THE UNITED STATES ENVIRONMENTAL PROTECTION
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Statutes and Legislative Historv
Executive Orders
Regulations
Guidelines and Reports
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THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
Statutes and Legislative History
Executive Orders
Regulations
Guidelines and Reports
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FOREWORD
It has been said that America is like a gigantic boiler in that
once the fire is lighted, there are no limits to the power it can
generate. Environmentally, the fire has been lit!
With a mandate from the President and an aroused public con-
cern over the environment, we are experiencing a new American
Revolution, a revolution in our way of life. The era which began
with the industrial revolution is over and things will never be
quite the same again. We are moving slowly, perhaps even grudg-
ingly at times, but inexorably into an age when social, spiritual
and aesthetic values will be prized more than production and
consumption. We have reached a point where we must balance
civilization and nature through our technology.
The U.S. Environmental Protection Agency, formed by Reor-
ganization Plan No. 3 of 1970, was a major commitment to this
new ethic. It exists and acts in the public's name to ensure that
due regard is given to the environmental consequences of actions
by public and private institutions.
In a large measure, this is a regulatory role, one that encom-
passes basic, applied, and effects research; setting and enforcing
standards; monitoring; and making delicate risk-benefit decisions
aimed at creating the kind of world the public desires.
The Agency was not created to harass industry or to act as a
shield behind which man could wreak havoc on nature. The great-
est disservice the Environmental Protection Agency could do to
American industry is to be a poor regulator. The environment
would suffer, public trust would diminish, and instead of free
enterprise, environmental anarchy would result.
It was once sufficient that the regulatory process produce wise
and well-founded courses of action. The public, largely indifferent
to regulatory activities, accepted agency actions as being for the
"public convenience and necessity." Credibility gaps and cynicism
make it essential not only that today's decisions be wise and
well-founded but that the public know this to be true. Certitude,
not faith, is de rigueur.
In order to participate intelligently in regulatory proceedings,
the citizen should have access to the information available to the
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IV
agency. EPA's policy is to make the fullest possible disclosure of
information, without unjustifiable expense or delay, to any inter-
ested party. With this in mind, the EPA Compilation of Legal
Authority was produced not only for internal operations of EPA,
but as a service to the public, as we strive together to lead the way,
through the law, to preserving the earth as a place both habitable
by and hospitable to man.
WILLIAM D. RUCKELSHAUS,
Administrator
U.S. Environmental Protection Agency
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PREFACE
Reorganization Plan No. 3 of 1970 transferred 15 governmental
units with their functions and legal authority to create the U.S.
Environmental Protection Agency. Since only the major laws
were cited in the Plan, the Administrator, William D. Ruckelshaus,
requested that a compilation of EPA legal authority be researched
and published.
The publication has the primary function of providing a work-
ing document for the Agency itself. Secondarily, it will serve as a
research tool for the public.
A permanent office in the Office of Legislation has been estab-
lished to keep the publication updated by supplements.
It is the hope of the EPA that this set will assist in the awesome
task of developing a better environment.
MARY LANE REED WARD GENTRY, J.D.
Assistant Director for Field Operations
Office of Legislation
U.S. Environmental Protection Agency
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ACKNOWLEDGEMENT
The idea of producing a compilation of the legal authority of
EPA was conceived and commissioned by William D. Ruckelshaus,
Administrator of EPA. The production of this compilation in-
volved the cooperation and effort of numerous sources, both within
and outside the Agency. The departmental libraries at Justice and
Interior were used extensively; therefore we express our appreci-
ation to Marvin P. Hogan, Librarian, Department of Justice;
Arley E. Long, Land & Natural Resources Division Librarian,
Department of Justice; Frederic E. Murray, Assistant Director,
Library Services, Department of the Interior.
For exceptional assistance and cooperation, my gratitude to:
Gary Baise, formerly Assistant to the Administrator, currently
Director, Office of Legislation, who first began with me on this
project; A. James Barnes, Assistant to the Administrator; K. Kirke
Harper, Jr., Special Assistant for Executive Communications;
John Dezzutti, Administrative Assistant, Office of Executive Com-
munications; Roland 0. Sorensen, Chief, Printing Management
Branch, and Jacqueline Gouge and Thomas Green, Printing Man-
agement Staff; Ruth Simpkins, Janis Collier, Wm. Lee Rawls,
Peter J. McKenna, James G. Chandler, Jeffrey D. Light, Randy
Mott, Thomas H. Rawls, John D. Whittaker, John M. Himmelberg,
Dana W. Smith, and Linda L. Payne, and a beautiful staff who
gave unlimited effort; and to many others behind the scenes who
rendered varied assistance.
MARY LANE REED WARD GENTRY, J.D.
Assistant Director for Field Operations
Office of Legislation
U.S. Environmental Protection Agency
VI
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INSTRUCTIONS
The goal of this text is to create a useful compilation of the legal
authority under which the U.S. Environmental Protection Agency
operates. These documents are for the general use of personnel of
the EPA in assisting them in attaining the purposes set out by the
President in creating the Agency. This work is not intended and
should not be used for legal citations or any use other than as
reference of a general nature. The author disclaims all responsibil-
ity for liabilities growing out of the use of these materials contrary
to their intended purpose. Moreover, it should be noted that por-
tions of the Congressional Record from the 92nd Congress were
extracted from the "unofficial" daily version and are subject to
subsequent modification.
EPA Legal Compilation consists of the Statutes with their
legislative history, Executive Orders, Regulations, Guidelines and
Reports. To facilitate the usefulness of this composite, the Legal
Compilation is divided into the eight following chapters:
A. General E. Pesticides
B. Air F. Radiation
C. Water G. Noise
D. Solid Waste H. International
PESTICIDES
The chapter labeled "Pesticides" and color coded green contains
the legal authority of the Agency as it applies to pesticide pollution
abatement. It is well to note that any law which is applicable to
more than one chapter of the Compilation will appear in each of
the chapters; however, its legislative history will be cross-refer-
enced into the "General" chapter where it is printed in full.
SUBCHAPTERS
Statutes and Legislative History
For convenience, the Statutes are listed throughout the Com-
pilation by a one-point system, i.e., 1.1,1.2,1.3, etc., and Legislative
History begins wherever a letter follows the one-point system.
Thusly, any l.la, l.lb, 1.2a, etc., denotes the public laws com-
prising the 1.1, 1.2 statute. Each public law is followed by its
legislative history. The legislative history in each case consists of
vii
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viii INSTRUCTIONS
the House Report, Senate Report, Conference Report (where
applicable), the Congressional Record beginning with the time the
bill was reported from committee.
Example:
1.1 The Federal Insecticide, Fungicide, and Rodenticide Acts, as
amended, 7 U.S.C. §§135-135k (1970).
l.la The Insecticide Act, April 26, 1910, P.L. 61-152, 36
Stat. 331.
(1) Senate Committee on Agriculture and Forestry,
S. REP. No. 436, 61st Cong., 2d Sess. (1910).
(2) House Committee on Interstate and Foreign Com-
merce, H.R. REP. No. 990, 61st Cong., 2d Sess.
(1910).
(3) Congressional Record, Vol. 45 (1910) :
(a) April 4: Debated, amended and passed Sen-
ate, pp.4204-4206;
(b) April 18: Debated, amended and passed
House, pp. 4914-4920;
(c) April 19: Senate agrees to House amend-
ments, p. 4959.
This example not only demonstrates the pattern followed for
legislative history, but indicates the procedure where only one
section of a public law appears. You will note that the Congression-
al Record cited pages are only those pages dealing with the discus-
sion and/or action taken pertinent to the section of law applicable
to EPA, In the event there is no discussion of the pertinent section,
only action or passage, then the asterisk (*) is used to so indicate,
and no text is reprinted in the Compilation. In regard to the situ-
ation where only one section of a public law is applicable, then
only the parts of the report dealing with same are printed in
the Compilation.
Secondary Statutes
Many statutes make reference to other laws and rather than
have this manual serve only for major statutes, these secondary
statutes have been included where practical. These secondary
statutes are indicated in the table of contents to each chapter by
a bracketed cite to the particular section of the major act which
made the reference.
Citations
The United States Code, being the official citation, is used
throughout the Statute section of the Compilation.
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INSTRUCTIONS
IX
TABLE OF STATUTORY SOURCE
Statutes
Source
1.1 The Federal Insecticide, Fungi-
cide, and Rodenticide Act, as
amended, 7 U.S.C. §§135-135k
(1970).
1.2 Federal Food, Drug, and Cos-
metic Act, as amended, 21 U.S.C.
§§346, 346a, 348 (1970).
1.3 Studies of the Effect in Use of
Chemicals, as amended, 16 U.S.C.
§§742d-l (1968).
1.4 The Public Health Service Act,
as amended, 42 U.S.C. §241, 243,
246,264 (1970).
1.5 Special Packaging of Household
Substances for the Protection of
Children, 15 U.S.C. §1471 et seq.
(1970).
1.6 Hearings: Presiding Employees:
Powers and Duties; Burden of
Proof; Evidence; Records as a
Basis of Decision, 5 U.S.C.
§556(c) (1966).
1.7 Record on Review and Enforce-
ment of Agency Orders, as
amended, 28 U.S.C. §2112 (1966).
1.8 Courts of Appeals; Certiorari,
Appeal; Certified Questions, as
amended, 28 U.S.C. §1254 (1948).
1.9 Adulterated Food, as amended,
21 U.S.C. §432(a) (1968).
1.10 Appointment and Compensation
of Advisory Committee, Color Ad-
ditive Amendments of 1960, as
amended, 21 U.S.C. §§376 (b) (5)
(D) (1970).
1.11 Regulations and Hearings—Au-
thority to Promulgate Regula-
tions, 21 U.S.C. §371 (1960).
1.12 Penalties—Violation of §331 of
this Title, 21 U.S.C. §333(c)
(1970).
The Reorg. Plan No. 3 of 1970.
Directly cited in Reorg. Plan No. 3 of
1970.
Directly cited in the Reorg. Plan No. 3
of 1970.
Reorg. Plan No. 3 of 1970.
In first section of Act, direct reference
is made to both FIFRA and the Fed-
eral Food, Drug, and Cosmetic Act,
section over which we were given au-
thority through Reorg. Plan No. 3 of
1970.
Referred to in the FIFRA at §135b
and FD&C Act at §246a(d) (5).
Referred to in FIFRA at §135b(d),
and FD&C Act at §346a (i) (2) (3),
348 (g) (2), and Special Packaging of
Household Substances Act at §1474
(b)(l).
Referred to in FIFRA at §135b(d),
and FD&C Act at §§346a(i) (5),
348 (g) (5), and Special Packaging of
Household Substances Act at
§1474(b) (5).
Referred to in FD&C Act at §§346,
346a(a),348(a((2).
Referred to in FD&C Act at §346a(g).
Referred to in FD&C Act at §346a(k),
and Special Packaging of Household
Substances Act at §1474 (a).
Referred to in FD&C Act in §346a (n).
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INSTRUCTIONS
Statutes
Source
Referred to in Public Health Service
Act at §241 (h).
Special Packaging of Household Sub-
stances Act at §1474 (a), (b).
Special Packaging of Household Sub-
stances Act at §1474 (b) (3), (4).
Referred to in Special Packaging of
Household Substances Act at
§1475(b).
1.13 Research and Development Act,
Contracts, as amended, 10 U.S.C.
§§2353,2354 (1956).
1.14 Rule. Making, Administrative
Procedure, as revised, 5 U.S.C.
§553 (1966).
1.15 Judicial Review, Relief Pending
Review; Scope, as revised, 5
U.S.C. §§705, 706(2) (A),(B),
(C),(D) (1966).
1.16 Per Diem, Travel and Transpor-
tation Expenses; Experts and
Consultants; Individuals Serving
Without Pay, as amended, 5
U.S.C. §5703 (1966).
Executive Orders
The Executive Orders are listed by a two-point system (2.1,
2.2, etc.). Executive Orders found in General are ones applying to
more than one area of the pollution chapters.
Regulations
The Regulations are noted by a three-point system (3.1, 3.2,
etc.). Included in the Regulations are those not only promulgated
by the Environmental Protection Agency, but those under which
the Agency has direct contact.
Guidelines and reports
This subchapter is noted by a four-point system (4.1, 4.2, etc.).
In this subchapter is found the statutorily required reports of
EPA, published guidelines of EPA, selected reports other than
EPA's and inter-departmental agreements of note.
UPDATING
Periodically, a supplement will be sent to the interagency distri-
bution and made available through the U.S. Government Print-
ing Office in order to provide an accurate working set of EPA
Legal Compilation.
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CONTENTS
E. PESTICIDES
Volume I
Page
1. Statutes and Legislative History 1
1.1 The Federal Insecticide, Fungicide, and Rodenticide Acts,
as amended, 7 U.S.C. §§135-135k (1970) 3
l.la The Insecticide Act, April 26, 1910, P.L. 61-152,
36 Stat. 331. 20
(1) Senate Committee on Agriculture and For-
estry, S. REP. No. 436, 61st Cong., 2d Sess.
(1910). 27
(2) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 990, 61st Cong.,
2d Sess. (1910) 30
(3) Congressional Record, Vol. 45 (1910):
(a) April 4: Debated, amended and passed
Senate, pp. 4204-4206; 37
(b) April 18: Debated, amended and passed
House, pp. 4917-4918, 4920; 43
(c) April 19: Senate agrees to House amend-
ments, p. 4959. 48
l.lb Federal Insecticide, Fungicide, and Rodenticide
Act, June 25, 1947, P.L. 80-104, 61 Stat. 163 48
(1) House Committee on Agriculture, H.R. REP.
No. 313, 80th Cong., 1st Sess. (1947). 61
(2) Senate Committee on Agriculture and For-
estry, S. REP. No. 199, 80th Cong., 1st Sess.
(1947). 69
(3) Congressional Record, Vol. 93 (1947):
(a) May 12: Passed House, pp. 5050-5055; 75
(b) June 16: Passed Senate, pp. 7007-7008. 86
l.lc Reorganization Plan No. 2 of 1953, 67 Stat. 633. 87
l.ld Nematocide, Plant Regulator, Defoilant and Des-
iccant Amendments of 1959, August 7, 1959, P.L.
86-139, 73 Stat. 286. 89
(1) House Committee on Agriculture, H.R. REP.
No. 552, 86th Cong., 1st Sess. (1959). 93
(2) Senate Committee on Agriculture and For-
estry, S. REP. No. 519, 86th Cong., 1st Sess.
(1959). 104
(3) Congressional Record, Vol. 105 (1959):
(a) July 6: Amended and passed House, pp.
12712-12713; 116
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xii CONTENTS
Page
(b) July 16: Amended and passed Senate,
pp. 13588; 118
(c) July 29: House concurs in Senate amend-
ment, p. 14629. 119
l.le Additional Time for Registration of Certain Nem-
atocides, Plant Regulators, Defoliants and Des-
iccants, March 29, 1961, P.L. 87-10, 75 Stat. 18. 119
(1) Senate Committee on Agriculture and For-
estry, S. REP. No. 74, 87th Cong., 1st Sess.
(1961). 120
(2) House Committee on Agriculture, H.R. REP.
No. 61, 87th Cong., 1st Sess. (1961). 125
(3) Congressional Record, Vol. 107 (1961):
(a) March 20: Amended and passed Senate
pp. 4282-4283; 130
(b) March 21: Passed House, p. 4399 131
l.lf Food Additives Transitional Provision Amend-
ment of 1961, April 7, 1961, P.L. 87-19, 75 Stat.
42. 132
(1) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 53, 87th Cong.,
1st Sess. (1961). 134
(2) Senate Committee on Labor and Public Wel-
fare, S. REP. No. 86, 87th Cong., 1st Sess.
(1961). 151
(3) Congressional Record, Vol. 107 (1961):
(a) March 14: Amended and passed House,
pp. 3924-3926; 163
(b) March 27: Passed Senate, pp. 4874-4875. 168
l.lg Amendments to the Federal Insecticide, Fungi-
cide, and Rodenticide Act, May 12, 1964, P.L. 88-
305, 78 Stat. 190. 169
(1) Senate Committee on Agriculture and For-
estry, S. REP. No. 573, 88th Cong., 1st Sess.
(1963). 174
(2) House Committee on Agriculture, H.R. REP.
No. 1125, 88th Cong., 2d Sess. (1964) 208
(3) Congressional Record:
(a) Vol. 109 (1963), Oct. 22: Considered and
passed Senate, pp. 20077-20081; 240
(b) Vol. 110 (1964), Feb. 17: Considered and
passed House, amended, pp. 2947-2950; 248
(c) Vol. 110 (1964), April 8: Senate con-
curred in House amendment with an
amendment, pp. 7188-7190; 253
(d) Vol. 110 (1964), April 29: House con-
curred in Senate amendment, pp. 9421. - 258
l.lh Food Additives Transitional Provisions Amend-
ment of 1964, October 3, 1964, P.L. 88-625, §3, 78
Stat. 1002. 259
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CONTENTS xiii
Page
(1) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 1770, 88th Cong.,
2d Sess. (1964). 260
(2) Senate Committee on Labor and Public
Works, S. REP. No. 1593, 88th Cong., 2d
Sess. (1964). 269
(3) Congressional Record, Vol. 110 (1964):
(a) Sept. 3: Passed House, pp. 21597-21599; 279
(b) Sept. 25: Passed Senate, p. 22900.*1 _...__ 281
l.li Organized Crime Control Act of 1969, October 15,
1970, P.L. 91-452, Title II, §204, 84 Stat. 928 281
(1) Senate Committee on the Judiciary, S. REP.
No. 91-617, 91st Cong., 1st Sess. (1969) 282
(2) House Committee on the Judiciary, H.R.
REP. No. 91-1549, 91st Cong., 2d. Sess.
(1970). _.___. 294
(3) Congressional Record, Vol. 116 (1970):
(a) Jan. 21, 22, 23: Debated in Senate, pp.
587-588, 601, 852-853, 952; 296
(b) Jan. 23: Amended and passed Senate,
pp. 971, 972; 300
(c) Oct. 6, 7: Debated, amended, and passed
House, pp. 35196-35197, 35200, 35207-
35208, 35012-35013, 35291, 35303-35304,
35313, 35321, 35335, 36363-36364; 301
(d) Oct. 12: Debated, Senate concurred in
House amendment, pp. 36280-36283,
36293-36298, 36296. 310
l.lj Poison Prevention Packaging Act of 1970, De-
cember 30, 1970, P.L. 91-601, 84 Stat. 1670.
[See Pesticides 1.6-1.60(4) (c) for text and legis-
lative history.] 314
1.2 The Federal Food, Drug, and Cosmetic Act, as amended,
21 U.S.C. §§346, 346a, 348 (1970) 314
1.2a Food, Drug, and Cosmetic Act, 1906, June 30,
1906, P.L. 59-384, 34 Stat. 768 330
(1) Senate Committee on Manufacture, S. REP.
No. 8, 59th Cong., 1st Sess. (1905). 337
(2) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 2118 (parts 1 &
2), 59th Cong., 1st Sess. (1906) 338
(3) Committee of Conference, H.R. REP. No.
5056, 59th Cong., 1st Sess. (1906). 348
(4) Second Committee of Conference, H.R. REP.
No. 5096, 59th Cong., 1st Sess. (1906). 349
(5) Congressional Record, Vol. 40 (1906):
(a) Jan. 10, 16, 17, 18, 23, Feb. 2, 19, 20, 21:
Debated and passed Senate, pp. 894-898,
1129-1135, 1216-1221, 1414-1417, 2643-
2644, 2654-2658, 2662-2666, 2719-2722,
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xiv CONTENTS
Page
2728-2729, 2747-2748, 2755-2758, 2761-
2763, 2766-2767, 2773; 359
(b) May 7, June 21, 22, 23: Debated, amend-
ed and passed House, pp. 6464-6467,
8889-8915, 9005, 9048-9052, 9063-9070,
9075; 457
(c) June 27: First conference report sub-
mitted to Senate, pp. 9379-9381;* 484
(d) June 27: First conference report submit-
ted to House, p. 9417;* 489
(e) June 28: First conference report with-
drawn in Senate, p. 9459;* 489
(f) June 28, 29: Second conference report
submitted and passed Senate, pp. 9472,
9474, 9495-9596; 489
(g) June 29: Second conference report sub-
mitted and passed House, pp. 9735,
9737-9738, 9740. 490
1.2b Federal Food, Drug, and Cosmetic Act, June 25,
1938, P.L. 75-717, §406, 52 Stat. 1049. 492
(1) Senate Committee on Commerce, S. REP.
No. 91, 75th Cong., 1st Sess. (1937). 493
(2) Senate Committee on Commerce, S. REP.
No. 152, 75th Cong., 1st Sess. (1937) 496
(3) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 2139, 75th Cong.,
3rd Sess. (1938). 498
(4) Committee of Conference, H.R. REP. No.
2716, 75th Cong., 3rd Sess. (1938). 506
(5) Congressional Record:
(a) Vol. 81 (1937), March 8, 9: Debated,
amended and passed Senate, pp. 1962,
2010, 2013-2014, 2016, 2018-2019; 513
(b) Vol. 83 (1938), May 31: Made Special
Order and debated, pp. 7771-7778, 7780-
7781; 515
(c) Vol. 83 (1938), June 1: Amended and
passed House, pp. 7889, 7891, 7893-7894,
7897-7898, 7903; 523
(d) Vol. 83 (1938), June 2: Senate disagrees
to House amendments, p. 7955;* 526
(e) Vol. 83 (1938), June 10: Senate agrees
to conference report, pp. 8731-8738;* .... 526
(f) Vol. 83 (1938), June 13: House agrees to
conference report, pp. 9095-9101. 527
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CONTENTS xv
Volume II
Page
1.2c 1940 Reorganization Plan No. IV, §12, 54 Stat.
1237. 529
1.2d 1953 Reorganization Plan No. I, §§5, 8, 67 Stat.
632. „ 529
1.2e Food Additives Amendments of 1958, September
6, 1958, P.L. 85-929, §§3(c), 4, 6(a), 72 Stat.
1784. 529
(1) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 2284, 85th Cong.,
2d Sess. (1958). 537
(2) Senate Committee on Labor and Public Wel-
fare, S. REP. No. 2422, 85th Cong., 2d Sess.
(1958). - 565
(3) Congressional Record, Vol. 104 (1958):
(a) Aug. 23: Amended and passed Senate,
pp. 19358-19359;* 588
(b) Aug. 23: House concurs in Senate
amendments, p. 19641.* 588
1.2f Color Additives Amendments of 1960, July 12,
1960, P.L. 86-618, Title I, Section 103(a)(l),
74 Stat. 398. 588
(1) Senate Committee on Labor and Public Wel-
fare, S. REP. No. 795, 86th Cong., 1st Sess.
(1959). 589
(2) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 1761, 86th Cong.,
2d Sess. (1960) _____ 609
(3) Congressional Record:
(a) Vol. 105 (1959), Aug. 24: Amended and
passed Senate, pp. 16776-16780;* 651
(b) Vol. 106 (1960), June 25: Debated,
amended and passed House, pp. 14349-
14355,14357-14359,14361-14362, 14378;* 652
(c) Vol. 106 (1960), June 30: Senate con-
curs in House amendments, pp. 15133-
15137.* 664
1.2g Administrative Agency Proceedings Act, August
28, 1958, P.L. 85-791, §20, 72 Stat. 947 665
(1) House Committee on the Judiciary, H.R.
REP. No. 842, 85th Cong., 1st Sess. (1957). .. 666
(2) Senate Committee on the Judiciary, S. REP.
No. 2129, 85th Cong., 2d Sess. (1958). 668
(3) Congressional Record:
(a) Vol. 103 (1957), Aug. 5: Amended and
passed House, pp. 13617-13621;* 671
(b) Vol. 104 (1958), Aug. 14: Passed Senate,
p. 17537.* 671
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xvi CONTENTS
Page
1.2h Amendments to Food Additives, June 29, I960,
P.L. 86-546, 74 Stat. 255 671
(1) House Committee on the Judiciary, H.R.
REP, No. 1462, 86th Cong., 2d Sess. (1960). 672
(2) Senate Committee on the Judiciary, S. REP.
No. 1566, 86th Cong., 2d Sess. (I960).* 674
(3) Congressional Record, Vol. 106 (1960):
(a) April 19: Amended and passed House, p.
8190; * 674
(b) June 18: Passed Senate, p. 13203.* 674
1.2i Drug Amendments of 1962, October 10,1962, P.L.
87-781, Title I, Section 104(f) (1), 76 Stat. 785..- 674
(1) Senate Committee on the Judiciary, S. REP.
No. 1744 (part 1 & 2), 87th Cong., 2d Sess.
(1962). 675
(2) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 2464, 87th Cong.,
Sess. (1962). 676
(3) Committee of Conference, H.R. REP. No.
2526, 87th Cong., 2d Sess. (1962) 678
(4) Congressional Record, Vol. 108 (1962):
(a) Aug. 23: Debated, amended, and passed
Senate, pp. 17364-17422;* 682
(b) Sept. 27: Amended and passed House,
pp. 21092, 21096-21097, 21099-21100; .... 682
(c) Oct. 3: Senate agrees to conference re-
port, pp. 22037, 22039, 22091-22092,
22044-22045, 22047, 22050; 683
(d) Oct. 4: House agrees to conference re-
port, pp. 22323, 22325. 691
l.Zj Heart Disease, Cancer, Stroke and Kidney Dis-
ease Amendments of 1970, October 30, 1970,
P.L. 91-515, Title VI, Section 601(d)(l), 84 Stat.
1311. 691
(1) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 91-1297, 91st
Cong., 2d Sess. (1970).* 691
(2) Senate Committee on Labor and Public Wel-
fare, S. REP. No. 91-1090, 91st Cong., 2d
Sess. (1970).* 691
(3) Committee of Conference, H.R. REP. No.
91-1590, 91st Cong., 2d Sess. (1970).* 692
(4) Congressional Record, Vol. 116 (1970):
(a) Aug. 12: Amended and passed House, p.
28532; * 692
(b) Sept. 9: Amended and passed Senate, p.
31013; * 692
(c) Oct. 13: House agrees to conference re-
port, pp. 36589-36591;* 692
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CONTENTS xvii
Page
(d) Oct. 14: Senate agrees to conference re-
port, pp. 36888-36892;* 692
1.2k Comprehensive Health Manpower Training Act
of 1971, November 18, 1971, P.L. 92-157, Title
III, §303(a), 85 Stat. 464 692
(1) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 92-258, 92d Cong.,
1st Sess. (1971).* _______ 693
(2) Senate Committee on Labor and Public Wel-
fare, S. REP. No. 92-251, 92d Cong., 1st
Sess. (1971).* 693
(3) Committee of Conference, H.R. REP. No.
92-578, 92d Cong., 1st Sess. (1971).* 693
(4) Congressional Record, Vol. 117 (1971):
(a) July 1: Considered and passed House;* 693
(b) July 14: Considered and passed Senate,
amended;* 693
(c) Oct. 19: Senate agreed to conference re-
port;* 693
(d) Nov. 9: House agreed to conference re-
port.* -... 693
1.21 Federal Environmental Pesticide Control Act of
1972, P.L. 92-516, §3(3), 86 Stat. 998. 693
(1) House Committee on Agriculture, H.R. REP.
No. 92-511, 92d Cong., 1st Sess. (1971).* ____. 694
(2) Senate Committee on Agriculture and For-
estry, S. REP. No. 92-838, 92d Cong., 2d
Sess. (1972).* 694
(3) Senate Committee on Commerce, S. REP.
No. 92-970, 92d Cong., 2d Sess. (1972).* ___. 694
(4) Committee of Conference, H.R. REP. No.
92-1540, 92d Cong., 2d Sess. (1972).* 694
(5) Congressional Record:
(a) Vol. 117 (1971), Nov. 8, 9: Considered
and passed House;* 694
(b) Vol. 118 (1972), Sept. 26; Considered
and passed Senate, amended;* 694
(c) Vol. 118 (1972), Oct. 5: Senate agreed
to conference report;* 694
(d) Vol. 118 (1972), Oct. 12: House agreed
to conference report.* 694
1.3 Studies of Effects in Use of Chemicals, as amended, 16
U.S.C. §742d-l (1968) 695
1.3a Pesticide Research Act, August 1, 1958, P.L. 85-
582, 72 Stat. 479. 695
(1) Senate Committee on Interstate and Foreign
Commerce, S. REP. No. 1592, 85th Cong., 2d
Sess. (1958). 696
(2) House Committee on Merchant Marine and
Fisheries, H.R. REP. No. 2181, 85th Cong.,
2d Sess. (1958). 702
-------
xviii CONTENTS
Page
(3) Congressional Record, Vol. 104 (1958):
(a) May 29: Passed Senate, pp. 9797-9798; 703
(b) July 21: Amended and passed House, p.
14439; * 705
(c) July 23: Senate concurs in House amend-
ments, p. 14741.* 705
1.3b Fish and Wildlife Studies, September 16, 1959,
P.L. 86-279, 73 Stat. 563. 705
(1) Senate Committee on Interstate and Foreign
Commerce, S. REP. No. 708, 86th Cong., 1st
Sess. (1959). 705
(2) House Committee on Merchant Marine and
Fisheries, H.R. REP. No. 975, 86th Cong., 1st
Sess. (1959). 710
(3) Congressional Record, Vol. 105 (1959):
(a) Aug. 19: Amended and passed Senate,
p. 16345;* 715
(b) Sept. 2: Amended and passed House, pp.
17768-17769;* 716
(c) Sept. 10: Senate concurs in House
amendments, p. 18938. 716
1.3c Protection of Fish and Wildlife from Pesticides,
October 1, 1965, P.L. 89-232, 79 Stat. 902. 716
(1) Senate Committee on Commerce, S. REP. No.
169, 89th Cong., 1st Sess. (1965). 717
(2) House Committee on Merchant Marine and
Fisheries, H.R. REP. No. 1002, 89th Cong.,
1st Sess. (1965). 719
(3) Congressional Record, Vol. Ill (1965):
(a) April 29: Amended and passed Senate,
pp. 8967-8968;* 722
(b) Sept. 20: Passed House, p. 24374. 722
1.3d Pesticide Research, July 11, 1968, P.L. 90-394,
82 Stat. 338 723
(1) House Committee on Merchant Marine and
Fisheries, H.R. REP. No. 1223, 90th Cong.,
2d Sess. (1968). 724
(2) Senate Committee on Commerce, S. REP.
No. 1236, 90th Cong., 2d Sess. (1968). 738
(3) Congressional Record, Vol. 114 (1968):
(a) June 24: Passed Senate, pp. 18356-
18357; 745
(b) June 27: Passed House, p. 19095. 746
1.4 Public Health Service Act, as amended, 42 U.S.C. §§241,
243,246,264 (1970).
(See, "General 1.12a-1.12ae(3) (c)" for legislative his-
tory) 747
1.5 Environmental Quality Branch of the Plant Protection
Division 766
1.5a The Organic Act of 1862, as amended, 7 U.S.C.
§§2201-2212 (1967). 766
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CONTENTS xix
Page
1.5b The President's Science Advisory Committee Re-
port on Pesticides, May 14, 1963, p. 22. 768
1.6c Agricultural Research Service, Department of
Agriculture and Related Agencies Appropriation
Act of 1965, September 2, 1965, P.L. 88-573,
Title I, 78 Stat. 862. 771
1.6 Special Packaging of Household Substances for Protec-
tion of Children, 15 U.S.C. §1471 et seq. (1972) 774
1.6a Poison Prevention Packaging Act of 1970, De-
cember 30, 1970, P.L. 91-601, 84 Stat. 1670. 780
(1) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 91-1642, 91st
Cong., 2d Sess. (1970). 786
(2) Senate Committee on Commerce, S. REP.
No. 91-845, 91st Cong., 2d Sess. (1970) __ 802
(3) Committee of Conference, H.R. REP. No.
91-1755, 91st Cong., 2d Sess. (1970). 807
(4) Congressional Record, Vol. 116 (1970):
(a) May 11: Considered and passed Senate,
pp. 14796-14798;* 816
(b) Dec. 7: Considered and passed House,
amended, pp. 40188-40193;* 816
(c) Dec. 16: Senate and House agreed to con-
ference report, pp. 41729-41730, 41948.* 816
1.6b Federal Environmental Pesticide Control Act of
1972, October 21, 1972, P.L. 92-516, §3(3), 86
Stat. 998. 817
(1) House Committee on Agriculture, H.R. REP.
No. 92-511, 92d Cong., 1st Sess. (1971).*.- 817
(2) Senate Committee on Agriculture and For-
estry, S. REP. No. 92-838, 92d Cong., 2d
Sess. (1972).* 817
(3) Senate Committee on Commerce, S. REP.
No. 92-970, 92d Cong., 2d Sess. 817
(4) Committee of Conference, H.R. REP. No.
92-1540, 92d Cong., 2d Sess. (1972).* 817
(5) Congressional Record:
(a) Vol. 117 (1971), Nov. 8, 9: Considered
and passed House;* 817
(b) Vol. 118 (1972), Sept. 26: Considered
and passed Senate, amended;* 817
(c) Vol. 118 (1972), Oct. 5: Senate agreed
to conference report;* 818
(d) Vol. 118 (1972), Oct. 12: House agreed
to conference report.* 818
1.7 Hearings; Presiding Employees; Powers and Duties;
Burden of Proof; Evidence; Record as a Basis of Deci-
sion, as revised, 5 U.S.C. §556(c) (1966). [Referred to
in 7 U.S.C. §135b(c), 21 U.S.C. §246a(d)(5)] 818
1.7a Administrative Procedure in Hearings Act, June
11, 1946, P.L. 79-404, §7, 60 Stat. 241. 819
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xx CONTENTS
Page
(1) Senate Committee on the Judiciary, S. REP.
No. 752, 79th Cong., 1st Sess. (1945) 821
(2) House Committee on the Judiciary, H.R. REP.
No. 1980, 79th Cong., 2d Sess. (1946). 834
(3) Congressional Record, Vol. 92 (1946):
(a) March 12: Debated and passed Senate,
pp. 2151, 2155-2159, 2162, 2165, 2167;.... 845
(b) May 24: Debated, amended and passed
House, pp. 5645, 5649, 5652-5653, 5655,
5665-5668; 851
(c) May 27: Senate concurs in House amend-
ment, pp. 5790. 855
1.7b Administrative Procedure in Hearings Amend-
ments, September 6, 1966, P.L. 89-554, §556, 80
Stat. 386. 856
(1) House Committee on the Judiciary, H.R.
REP. No. 901, 89th Cong., 1st Sess. (1965). 858
(2) Senate Committee on the Judiciary, S. REP.
No. 1380, 89th Cong., 2d Sess. (1966) 859
(3) Congressional Record:
(a) Vol. Ill (1965), Sept. 7: Considered and
passed House, p. 22954;* 860
(b) Vol. 112 (1966), July 25: Amended and
passed Senate, p. 17010;* 860
(c) Vol. 112 (1966), Aug. 11: House concurs
in Senate amendments, p. 19077;* 860
1.8 Record on Review and Enforcement of Agency Orders,
as amended, 28 U.S.C. §2112 (1966).
[Referred to in 7 U.S.C. §135b(d), 21 U.S.C. §§346a(i)-
(2)(3), 348(g)(2), 15 U.S.C. §1474(b)(l)] 860
1.8a Uniform Review, Records and Enforcement
Orders Amendments, August 28, 1958, P.L. 85-
791, §2, 72 Stat. 941. 860
(1) House Committee on the Judiciary, H.R.
REP. No. 842, 85th Cong., 1st Sess. (1957). 863
(2) Senate Committee on the Judiciary, S. REP.
No. 2129, 85th Cong., 2d Sess. (1958). 874
(3) Congressional Record:
(a) Vol. 103 (1957), Aug. 5: Amended and
passed House, pp. 13617-13618;* 881
(b) Vol. 104 (1958), Aug. 14: Passed Senate,
p. 17537. 881
1.9 Courts of Appeals; Certiorari; Appeal; Certified Ques-
tions, as amended, 28 U.S.C. §1254 (1948).
[Referred to in 7 U.S.C. §135b(d), 21 U.S.C. §§346a(i)-
(5), 348(g)(5), 15 U.S.C. §1474(b)(5)] 882
1.9a Appeals to and/or from the Circuit Court of Ap-
peals, March 3, 1911, P.L. 61-475, §§239, 240, 36
Stat. 1157. 883
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CONTENTS xxi
Page
(1) Senate Special Joint Committee on Revision
and Codification of Laws, S. REP. No. 388
(2) House Committee on Revision of the Laws,
(parts 1 and 2), 61st Cong., 2d Sess. (1910). 884
H.R. Doc. No. 783, (part 1), 61st Cong., 2d
Sess. (1910). 884
(3) House Committee on Revision of the Laws,
H.R. REP. No. 818, 61st Cong., 2d Sess.
(1910). 885
(4) Committee of Conference, S. DOC. No. 848,
61st Cong., 3rd Sess. (1911). 886
(5) Congressional Record, Vol. 46 (1911):
(a) Feb. 8: Amended and passed Senate, p.
2140;* 887
(b) Feb. 23: Amended and passed House, p.
3220; 887
(c) March 2: Senate agreed to conference
report, p. 3853; 887
(d) March 2: House agreed to conference
report, pp. 3998; 4000; 4012. 887
1.9b Judicial Code Amendments of 1925, February 13,
1925, P.L. 68-415, §1, 43 Stat. 938. 887
(1) House Committee on the Judiciary, H.R.
REP. No. 1075, 68th Cong., 2d Sess. (1925). 888
(2) Congressional Record, Vol. 66 (1925):
(a) Feb. 2: Amended and passed House, pp.
2877-2880; * 898
(b) Feb. 3: Amended and passed Senate, p.
2928; * 898
(c) Feb. 4: House agreed to Senate amend-
ments, p. 3005. 898
1.9c Writs of Error Abolished Amendments, January
31, 1928, P.L. 70-10, §1, 45 Stat. 54. 899
(1) House Committee on the Judiciary, H.R.
REP. No. 370, 70th Cong., 1st Sess. (1928). 899
(2) Congressional Record, Vol. 69 (1928):
(a) Jan. 14: Discharged and passed Senate
without amendment, p. 1486; 900
(b) Jan. 25: Passed House, without amend-
ment, p. 2040.* 900
1.9d District of Columbia Court of Appeals Act, June
7, 1934, P.L. 73-298, 48 Stat. 926. 900
(1) Senate Committee on the Judiciary, S. REP.
No. 917, 73rd Cong., 2d Sess. (1934). 901
(2) House Committee on the Judiciary, H.R.
REP. No. 1748, 73rd Cong., 2d Sess. (1934). 902
(3) Congressional Record, Vol. 78 (1934):
(a) May 10: Passed Senate, p. 8479; 904
(b) June 5: Passed House, pp. 10536-10537.* 905
1.9e Court of Appeals Review Act, June 25, 1948,
P.L. 80-773, §1254, 62 Stat. 928. 905
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xxii CONTENTS
Page
(1) House Committee on the Judiciary, H.R.
REP. No. 308, 80th Cong., 1st Sess. (1947). 906
(2) Senate Committee on the Judiciary, S. REP.
No. 1559, 80th Cong., 2d Sess. (1948). 908
(3) Congressional Record:
(a) Vol. 93 (1947), July 7: Passed House, p.
8392; * 910
(b) Vol. 94 (1948), June 12: Amended and
passed Senate, p. 7927;* 911
(c) Vol. 94 (1948), June 16: House concurs
in Senate amendments, p. 8501.* 911
1.10 Adulterated Food, as amended, 21 U.S.C. §342(a) (1968).
[Referred to in 21 U.S.C. §§346, 346a(a), 348(a)(2)]_._. 911
l.lOa Federal Food, Drug, and Cosmetic Act, June 25,
1938, P.L. 75-717, §402, 52 Stat. 1046. 912
(1) Senate Committee on Commerce, S. REP.
No. 91, 75th Cong., 1st Sess. (1937) 913
(2) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 2139, 75th Cong.,
3rd Sess. (1938). 920
(3) Committee of Conference, H.R. REP. No.
2716, 75th Cong., 3rd Sess. (1938). 921
(4) Congressional Record:
(a) Vol. 81 (1937), March 9: Amended and
passed Senate, p. 2009; 923
(b) Vol. 83 (1938), June 1: Amended and
passed House, p. 7903; 923
(c) Vol. 83 (1938), June 10: Senate agrees
to conference report, p. 8733; 924
(d) Vol. 83 (1938), June 13: House agrees
to conference report, pp. 9089-9090.*—. 924
l.lOb Federal Adulterated Food Amendments, July 22,
1954, P.L. 83-518, §2, 68 Stat. 511. 924
(1) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 1385, 83rd Cong.,
2d Sess. (1954). 925
(2) Senate Committee on Labor and Public Wel-
fare, S. REP. No. 1635, 83rd Cong., 2d Sess.
(1954). 929
(3) Congressional Record, Vol. 100 (1954):
(a) April 5: Amended and passed House, p.
4604; * 932
(b) July 6: Amended and passed Senate, p.
9726; 932
(c) July 8: House concurs in Senate amend-
ment, p. 10095.* 934
l.lOc Food Additives Amendment of 1958, September
6, 1958, P.L. 85-929, §3(a), (b), 72 Stat. 1784..... 934
(1) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 2284, 85th Cong.,
2d Sess. (1958). 935
-------
CONTENTS xxiii
Page
(2) Senate Committee on Labor and Public Wel-
fare, S. REP. No. 2422, 85th Cong., 2d Sess.
(1958). 938
(3) Congressional Record, Vol. 104 (1958):
(a) Aug. 13: Amended and passed House,
pp. 17412, 17414-17415, 17418, 17422-
17424; 941
(b) Aug. 23: Amended and passed Senate,
pp. 19358-19359; 949
(c) Aug. 23: House concurs in Senate amend-
ment, p. 19641.* 951
l.lOd Color Additive Amendments of 1960, July 12,
1960, P.L. 86-618, Title I, §§102(a) (1), (2),
105(c), 74 Stat. 397, 404. 951
(1) Senate Committee on Labor and Public Wel-
fare, S. REP. No. 795, 86th Cong., 1st Sess.
(1959). 952
(2) House Committee on Interstate and Foreign
Commerce, H.P. REP. No. 1761, 86th Cong.,
2d Sess. (1960). 957
(3) Congressional Record:
(a) Vol. 105 (1959), Aug. 24: Amended and
passed Senate, pp. 16780;* 966
(b) Vol. 106 (1960), June 25: Discharged,
amended, and passed House, pp. 14353,
14355-14358, 14373, 14377; 966
(c) Vol. 106 (1960), June 30: Senate concurs
in House amendment, p. 15133.* 972
l.lOe Animal Drugs in Feeds Amendments of 1968,
July 13, 1968, P.L. 90-399, §104, 82 Stat. 352. __._ 972
(1) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 875, 90th Cong.,
1st Sess. (1967). 973
(2) Senate Committee on Labor and Public Wel-
fare, S. REP. No. 1308, 90th Cong., 2d Sess.
(1968). 976
(3) Congressional Record:
(a) Vol. 113 (1967), Nov. 6: Amended and
passed House, p. 31291; 982
(b) Vol. 114 (1968), June 24: Amended and
passed Senate, p. 18424;* 983
(c) Vol. 114 (1968), July 2: House concurs
in Senate amendments, pp. 19713-19714. 983
1.11 Listings and Certification of Color Additives for Foods,
Drugs and Cosmetics—Unsafe Color Additives, as
amended, 21 U.S.C. §376(b)(5)(D) (1970).
[Referred to in 21 U.S.C. §346a(g)] 985
l.lla Federal Food, Drug, and Cosmetic Act Amend-
ments of 1962, October 10,1962, P.L. 87-781, Title
I, §104(f)(2), 76 Stat. 785. 985
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xxiv CONTENTS
Page
(1) Senate Committee on the Judiciary, S. REP.
No. 1744, 87th Cong., 2d Sess. (1962). 986
(2) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 2464, 87th Cong.,
2d Sess. (1962). 988
(3) Committee of Conference, H.R. REP. No.
2526, 87th Cong., 2d Sess. (1962) 993
(4) Congressional Record, Vol. 108 (1962):
(a) Aug. 23: Amended and passed Senate, p.
17422; * 997
(b) Sept. 27: Discharged, amended and
passed House, pp. 21052, 21083, 21097; 997
(c) Oct. 3: Senate concurred in conference
report, pp. 22039, 22053; 998
(d) Oct. 4: House concurs in conference
report, p. 22321. _"_.... 999
l.llb National Advisory Council Amendments, October
30, 1970, P.L. 91-515, Title VI, §601(d)(2), 84
Stat. 1311. 1000
(1) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 91-1297, 91st
Cong., 2d Sess. (1970). 1001
(2) Senate Committee on Labor and Public Wel-
fare, S. REP. No. 91-1090, 91st Cong., 2d
Sess. (1970). 1002
(3) Committee of Conference, H.R. REP. No.
91-1590, 91st Cong., 2d Sess. (1970) 1003
(4) Congressional Record, Vol. 116 (1970):
(a) Aug. 12: Considered and passed House,
p. 28532; 1006
(b) Sept. 9: Considered and passed Senate,
p. 31019; 1006
(c) Oct. 13: House agrees to conference
report, pp. 36589, 36591;* 1007
(d) Oct. 14: Senate agrees to conference
report, pp. 36888-36892.* 1007
1.12 Regulations and Hearings—Authority to Promulgate
Regulations, 21 U.S.C. §371 (1960).
[Referred to in 21 U.S.C. §346a(k), 15 U.S.C. §1474(a)] 1007
1.12a Federal Food, Drug, and Cosmetic Act—Regula-
tions and Hearings, June 25, 1938, P.L. 75-717,
§701, 52 Stat. 1055. 1010
(1) Senate Committee on Commerce, S. REP.
No. 91, 75th Cong., 1st Sess. (1937). 1012
(2) Senate Committee on Commerce, S. REP.
No. 152, 75th Cong., 1st Sess. (1937). 1015
(3) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 2139, 75th Cong.,
3rd Sess. (1938). 1018
(4) Committee of Conference, H.R. REP. No.
2716, 75th Cong., 3rd Sess. (1938). 1028
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CONTENTS xxv
Page
(5) Congressional Record:
(a) Vol. 81 (1937), March 9: Amended and
passed Senate, p. 2019;* 1031
(b) Vol. 83 (1938), June 1: Amended and
passed House, pp. 7891-7899; 1031
(c) Vol. 83 (1938), June 10: Senate agrees
to conference report, pp. 8731-8738;*.- 1040
(d) Vol. 83 (1938), June 13: House agrees
to conference report, pp. 9095-9100.*-. 1040
1.12b 1940 Reorganization Plan IV, Section 12, 54 Stat.
1237. 1040
1.12c Judicial Code, Definition, Amendments, June 25,
1948, P.L. 80-773, §32, 62 Stat. 991. 1041
(1) House Committee on the Judiciary, H.R.
REP. No. 308, 80th Cong., 1st Sess. (1947). 1041
(2) Senate Committee on the Judiciary, S. REP.
No. 1559, 80th Cong., 2d Sess. (1948). 1042
Volume III
(3) Congressional Record:
(a) Vol. 93 (1947), July 7: Amended and
passed House, p. 8392;* 1043
(b) Vol. 94 (1948), June 21: Amended and
passed Senate, p. 7927;* 1043
(c) Vol. 94 (1948), June 16: House concurs
in Senate amendment, p. 8499.* 1043
1.12d 1953 Reorganization Plan I, §§5, 8, 67 Stat. 631: 1043
1.12e Federal Pood, Drug, and Cosmetic Act Amend-
ments of 1954, April 15, 1954, P.L. 83-335, §2,
68 Stat. 55. 1044
(1) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 934, 83rd Cong.,
1st Sess. (1953) 1044
(2) Senate Committee on Labor and Public Wel-
fare, S. REP. No. 1060, 83rd Cong., 2d Sess.
(1954). 1046
(3) Congressional Record:
(a) Vol. 991 (1953), July 30: Passed House,
p. 10527;* ___. 1049
(b) Vol. 100 (1954), April 5: Passed Senate,
pp. 4556-4557 1049
1.12f 1956 Federal Food, Drug, and Cosmetic Amend-
ments, August 1, 1956, P.L. 84-905, §2, 70 Stat.
919. 1051
(1) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 2623, 84th Cong.,
2d Sess. (1956) 1053
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xxvi CONTENTS
Page
(2) Senate Committee on Labor and Public Wel-
fare, S. REP. No. 2752, 84th Cong., 2d Sess.
(1956) 1061
(3) Congressional Record, Vol. 102 (1956):
(a) July 16: Passed House, pp. 12911-
12912; * 1066
(b) July 23: Passed Senate, p. 13923.* 1066
1.12g Abbreviated Records on Review Act, August 28,
1958, P.L. 85-791, §21, 72 Stat. 948 1066
(1) House Committee on the Judiciary, H.R.
REP. No. 842, 85th Cong., 1st .Sess. (1957). 1066
(2) Senate Committee on the Judiciary, S. REP.
No. 2129, 85th Cong., 2d Sess. (1958). 1069
(3) Congressional Record:
(a) Vol. 103 (1957), Aug. 5: Amended and
passed House, p. 13620;* 1075
(b) Vol. 104 (1958), Aug. 14: Passed Senate,
p. 17537. 1075
1.12h 1960 Amendments to Federal Food, Drug, and
Cosmetic Act, July 12, 1960, P.L. 86-618, Title I,
§103(a) (4), 74 Stat. 398. 1076
(1) Senate Committee on Labor and Public Wel-
fare, S. REP. No. 795, 86th Cong., 1st Sess.
(1959). 1076
(2) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 1761, 86th Cong.,
2d Sess. (1960). 1080
(3) Congressional Record:
(a) Vol. 105 (1959), Aug. 24: Amended and
passed Senate, p. 16777;* 1085
(b) Vol. 106 (1960), June 25: Amended and
passed House, pp. 14334, 14373, 14376;* 1085
(c) Vol. 106 (1960), June 30: Senate concurs
in House amendments, p. 15133.* 1085
1.13 Penalties—Violation of Section 331 of this Title, 21
U.S.C. §333(c) (1970).
[Referred to in 21 U.S.C. §346a(n)] 1085
1.13a Federal Food, Drug, and Cosmetic Act Penalties,
June 25, 1938, P.L. 75-717, §303, 52 Stat. 1043.-. 1086
(1) Senate Committee on Commerce, S. REP.
No. 91, 75th Cong., 1st Sess. (1937). 1088
(2) Senate Committee on Commerce, S. REP.
No. 152, 75th Cong., 1st Sess. (1937) 1089
(3) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 2139, 75th Cong.,
3rd Sess. (1938). 1091
(4) Committee of Conference, H.R. REP. No.
2716, 75th Cong., 3rd Sess. (1938). 1092
(5) Congressional Record:
(a) Vol. 81 (1937), March 9: Amended and
passed Senate, p. 2005; 1094
-------
CONTENTS xxvii
Page
(b) Vol. 83 (1938), June 1: Amended and
passed House, p. 7903;* 1094
(c) Vol. 83 (1938), June 10: Senate agrees
to conference report, p. 8732;* 1094
(d) Vol. 83 (1938), June 13: House agrees to
conference report, pp. 9088-9089.* 1094
1.13b 1940 Reorganization Plan IV, §12, 54 Stat. 1237. 1094
1.13c 1951 Amendments to Federal Food, Drug, and
Cosmetic Act, October 26, 1951, P.L. 82-215, §2,
65 Stat. 649. ... 1094
(1) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 700, 82nd Cong.,
1st Sess. (1951) 1095
(2) Senate Committee on Labor and Public Wel-
fare, S. REP. No. 946, 82nd Cong., 1st Sess.
(1951). 1103
(3) Congressional Record, Vol. 97 (1951):
(a) Aug. 1: Amended and passed House, pp.
9333, 9334;* 1118
(b) Oct. 15: Amended and passed Senate,
pp. 13126; 13128; 13131; 1118
(c) Oct. 17: House concurs in Senate amend-
ments, p. 13378. 1119
1.13d 1953 Reorganization Plan I, §§5, 8, 67 Stat. 632... 1119
1.13e Food Coloring Amendments of 1960, July 12,
1960, P.L. 86-618, Title I, §105(b), 74 Stat. 403.. 1120
(1) Senate Committee on Labor and Public Wel-
fare, S. REP. No. 795, 86th Cong., 1st Sess.
(1959). 1121
(2) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 1761, 86th Cong.,
2d Sess. (1960). 1124
(3) Congressional Record:
(a) Vol. 105 (1959), Aug. 24: Amended and
passed Senate, p. 16778;* 1133
(b) Vol. 106 (1960), June 25: Amended and
passed House, pp. 14373, 14377;* 1133
(c) Vol. 106 (1960), June 30: Senate concurs
in House amendments, p. 15135.* 1133
1.13f Drug Abuse Control Amendments of 1965, July
15, 1965, P.L. 89-74, §§7, 9(d), 79 Stat. 233, 235. 1133
(1) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 130, 89th Cong.,
1st Sess. (1965) 1134
(2) Senate Committee on Labor and Public Wel-
fare, S. REP. No. 337, 89th Cong., 1st Sess.
(1965). 1136
(3) Congressional Record, Vol. Ill (1965):
(a) March 10: Amended and passed House,
pp. 4702-4703;* 1138
-------
xxviii CONTENTS
Page
(b) June 23: Amended and passed Senate,
p. 14609;* 1138
(c) July 8: House concurs in Senate amend-
ments, pp. 15977-15978.* 1138
1.13g Federal Food, Drug, and Cosmetic Act LSD
Amendments, October 24, 1968, P.L. 90-639, §3,
82 Stat. 1361. 1138
(1) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 1546, 90th Cong.,
2d Sess. (1968). 1139
(2) Senate Committee on Labor and Public Wel-
fare, S. REP. No. 1609, 90th Cong., 2d Sess.
(1968). 1149
(3) Committee of Conference, H.R. REP. No.
1958, 90th Cong., 2d Sess. (1968). 1156
(4) Congressional Record, Vol. 114 (1968):
(a) July 12: Amended and passed House,
pp. 21032-21040; 1158
(b) Oct. 4: Amended and passed Senate, pp.
29633, 29634; 1163
(c) Oct. 11: House agrees to conference re-
port, pp. 30761, 30762; 1165
(d) Oct. 11: Senate agrees to conference re-
port, pp. 30963, 30965 1167
1.13h Comprehensive Drug Abuse Prevention and Con-
trol Act, October 27, 1970, P.L. 91-513, Title II,
§701 (b), 84 Stat. 1281 1170
(1) Senate Committee on the Judiciary, S. REP.
No. 91-613, 91st Cong., 1st Sess. (1969) 1171
(2) House Committee on Interstate and Foreign
Commerce, H.R. REP. No. 91-1444, (Parts 1
and 2), 91st Cong., 2d Sess. (1970). 1174
(3) Committee of Conference, H.R. REP. No.
91-1603, 91st Cong., 2d Sess. (1970). 1176
(4) Congressional Record, Vol. 116 (1970):
(a) Jan. 28: Considered and passed Senate,
p. 1690;* 1177
(b) Sept. 24: Considered and passed House,
p. 33667;* 1177
(c) Oct. 7: Amended and passed Senate, pp.
35496-35497;* 1177
(d) Oct. 14: House agrees to conference re-
port, p. 36655;* 1177
(e) Oct. 14: Senate agrees to conference
report, p. 36885.* 1177
1.14 Research and Development Act, Contracts, as amended,
10U.S.C. §§2353,2354 (1956).
[Referred to in 42 U.S.C. §241 (h)] 1178
1.14a Armed Forces Research and Development Act,
July 16, 1952, P.L. 82-557, §§4, 5, 66 Stat. 725. .. 1179
-------
CONTENTS xxix
Page
(1) House Committee on Armed Services, H.R.
REP. No. 548, 82nd Cong., 1st Sess. (1951). 1181
(2) Senate Committee on Armed Services, S.
REP. No. 936, 82nd Cong., 1st Sess. (1951). 1194
(3) Congressional Record:
(a) Vol. 97 (1951), Aug. 2: Passed House,
pp. 9431-9433; 1204
(b) Vol. 98 (1952), July 3: Amended and
passed Senate, pp. 9053-9054; 1210
(c) Vol. 98 (1952), July 4: House concurs
in Senate amendments, pp. 9374-9375. _. 1212
1.14b Armed Forces Procurement Amendments of 1956,
August 10, 1956, P.L. 84-1028, §52353, 2354,
70A Stat. 134 1213
(1) House Committee on the Judiciary, H.R.
REP. No. 970, 84th Cong., 1st Sess. (1955). 1214
(2) Senate Committee on the Judiciary, S. REP.
No. 2484, 84th Cong., 2d Sess. (1956). 1217
(3) Congressional Record:
(a) Vol. 101 (1955), Aug. 1: Amended and
passed House, pp. 12718-12719; .... 1218
(b) Vol. 102 (1956), July 23: Amended and
passed Senate, p. 13953;* 1219
(c) Vol. 102 (1956), July 25: House concurs
in Senate amendment, p. 14455.* 1219
1.15 Rule Making, Administrative Procedure, as revised, 5
U.S.C. §553 (1966).
[Referred to in 15 U.S.C. §1474(a), (b)] 1219
1.15a Rule Making, June 11, 1946, P.L. 97-404, §4, 60
Stat. 238. 1220
(1) Senate Committee on the Judiciary, S. REP.
No. 752, 79th Cong., 1st Sess. (1945). 1221
(2) House Committee on the Judiciary, H.R.
REP. No. 1980, 79th Cong., 2d Sess. (1946). 1230
(3) Congressional Record, Vol. 92 (1946):
(a) March 12: Debated, amended and passed
Senate, pp. 2151-2152, 2155, 2157, 2161-
2162, 2165; 1241
(b) May 24: Debated, amended and passed
House, pp. 5645, 5649; 5650-5652, 5656,
5660-5661; 1244
(c) May 27: Senate concurs in the House
amendments, p. 5788.* 1248
1.15b Administrative Procedure and Rule Making,
September 6, 1966, P.L. 89-554, §553, 80 Stat.
383. 1248
(1) House Committee on the Judiciary, H.R.
REP. No. 901, 89th Cong., 1st Sess. (1965). 1249
(2) Senate Committee on the Judiciary, S. REP.
No. 1380, 89th Cong., 2d Sess. (1966) 1251
-------
xxx CONTENTS
Page
(3) Congressional Record:
(a) Vol. Ill (1965), Sept. 7: Passed House,
p. 22954;* 1251
(b) Vol. 112 (1966), July 25: Amended and
passed Senate, p. 17010;* 1252
(c) Vol. 112 (1966), Aug. 11: House concurs
in Senate amendments, p. 19077. 1252
1.16 Judicial Review; Relief Pending Review; Scope, as re-
vised, 5 U.S.C. §§705, 706(2) (A), (B), (C), (D) (1966).
[Referred to in 15 U.S.C. §1474(b) (3) (4)] 1252
1.16a Judicial Interim Relief and Review of Agencies
Acts, June 11, 1946, P.L. 79-404, §10(d), (e), 60
Stat. 243. .._. 1253
(1) Senate Committee on the Judiciary, S. REP.
No. 752, 79th Cong., 1st Sess. (1945) 1255
(2) House Committee on the Judiciary, H.R.
REP. No. 1980, 79th Cong., 2d Sess. (1946). 1261
(3) Congressional Record, Vol. 92 (1946):
(a) March 12: Amended and passed Senate,
pp. 2151, 2153, 2158, 2163, 2166; 1267
(b) May 24: Debated, amended and passed
House, pp. 5454-5457, 5660, 5666; 1270
(c) May 27: Senate concurs in House amend-
ments, p. 5790.* 1276
1.16b Judicial Interim Relief and Review of Agency
Amendments, September 6, 1966, P.L. 89-554,
§§705, 706, 80 Stat. 393. 1276
(1) House Committee on the Judiciary, H.R.
REP. No. 901, 89th Cong., 1st Sess. (1965). 1277
(2) Senate Committee on the Judiciary, S. REP.
No. 1380, 89th Cong., 2d Sess. (1966). 1279
(3) Congressional Record:
(a) Vol. Ill (1965), Sept. 7: Passed House,
p. 22954;* -- 1279
(b) Vol. 112 (1966), July 25: Amended and
passed Senate, pp. 17010, 17011;* 1279
(c) Vol. 112 (1966), Aug. 11: House concurs
in Senate amendments, p. 19077.* 1280
1.17 Per Diem, Travel and Transportation Expenses; Experts
and Consultants; Individuals Serving Without Pay, as
amended, 5 U.S.C. §5703 (1966).
[Referred to in 15 U.S.C. §1475(b)]
(See, "General 1.15a-1.15d(3) (c)" tor legislative his-
tory) 1280
1.18 Federal Water Pollution Control Act, as amended, 33
U.S.C. §1155(1) (1), (2) (1970) 1281
1.18a The Water Quality Improvement Act of 1970,
April 3, 1970, P.L. 91-224, §105(L), 84 Stat. 111. 1281
(1) House Committee on Public Works, H.R.
REP. No. 91-127, 91st Cong., 1st Sess.
(1969). 1283
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CONTENTS xxxi
Page
(2) Senate Committee on Public Works, S. REP.
No. 91-351, 91st Cong., 1st Sess. (1969). .... 1284
(3) Committee of Conference, H.R. REP. No.
91-940, 91st Cong., 2d Sess. (1970). 1285
(4) Congressional Record:
(a) Vol. 115 (1969), April 16: Amended and
passed House, p. 9293;* 1286
(b) Vol. 115 (1969), Oct. 7: Senate debated
and amended, pp. 28923-28924, 28987-
29008; 1286
(c) Vol. 115 (1969), Oct. 8: Passed Senate,
p. 29099;* 1338
(d) Vol. 116 (1970), March 24: Senate
agrees to conference report; 1338
(e) Vol. 116 (1970), March 25: House agrees
to conference report, p. 9334.* 1338
1.18b Federal Water Pollution Control Act Amend-
ments of 1972, October 18, 1972, P.L. 92-500,
§104(1), 86 Stat. 822. 1338
(1) Senate Committee on Public Works, S. REP.
No. 92-414, 92d Cong., 1st Sess. (1971) 1339
(2) House Committee on Public Works, H.R.
REP. No. 92-911, 92d Cong., 2d Sess. (1972). 1344
(3) Committee of Conference, H.R. REP. 92-
1465, 92d Cong., 2d Sess. (1972). 1345
(4) Congressional Record:
(a) Vol. 117 (1971), Nov. 2: Considered and
passed Senate;* 1345
(b) Vol. 118 (1972), Mar. 27-29: Considered
and passed House, amended;* 1345
(c) Vol. 118 (1972), Oct. 4: House and
Senate agreed to conference report;* .._. 1345
(d) Vol. 118 (1972), Oct. 18: Senate and
House overrode veto.* 1345
1.19 Interest on Certain Government Obligations, as amend-
ed, 26 U.S.C. §103 (1969).
(See, "General 1.9a-1.9d(4)(d)" for legislative history) 1346
1.20 Amortization of Pollution Control Facilities, as amend-
ed, 26 U.S.C. §169 (1969).
(See "General 1.4a-1.4a(5) (c)" for legislative history) 1347
2. Executive Orders 1351
2.1 E.O. 11643, Environmental Safeguards on Activities
for Animal Damage Control on Federal Lands; Feb-
ruary 9, 1972, 37 Fed. Reg. 2875 (1972) 1353
3. Regulations 1355
3.1 Regulations for the Enforcement of the Federal Insec-
ticide, Fungicide, and Rodenticide Act, U.S. Environ-
mental Protection Agency, 40 C.F.R. §162.1-162.36
(1970) 1357
3.2 Interpretations, Regulations for the Enforcement of
FIFRA, U.S. Environmental Protection Agency, 40
-------
xxxii CONTENTS
C.F.R. §§162.100-162.125 (1970). _... 1357
3.3 Certification of Usefulness of Pesticide Chemicals, U.S.
Environmental Protection Agency, 40 C.F.R. §163.1-
163.12 (1959). 1357
3.4 Rules Governing the Appointment, Compensation, and
Proceedings of an Advisory Committee; and Rules of
Practice Governing Hearings Under the Federal In-
secticide, Fungicide, and Rodenticide Act, U.S. Environ-
mental Protection Agency, 40 C.F.R. §164.1-164.44
(1972) 1357
3.5 FAA Certification of Private Agricultural Operations,
Federal Aviation Administration, 14 C.F.R. §137.1-
137.77 (1968). 1357
3.6 Tolerances and Exemptions from Tolerances for Pesti-
cide Chemicals in or on Raw Agricultural Commodities,
U.S. Environmental Protection Agency, 40 C.F.R.
§180.1-180.1023 (1972). 1357
4. Guidelines and Reports 1359
4.1 Interdepartmental Agreements. 1361
4.1a Interdepartmental Agreement for Protection of
Public Health and Quality of Environment be-
tween Departments of Agriculture, Interior, and
Health, Education and Welfare concerning eco-
nomic poisons, March 3, 1970, 35 Fed. Reg. 4014
(1970). 1361
4.1b Agreement Between Department of Health, Edu-
cation, and Welfare and Environmental Protec-
tion Agency, December 22, 1971, 36 Fed Reg.
24234. .... 1364
4.1c Interagency Agreement Between the Departs
ment of Health, Education and Welfare and the
Environmental Protection Agency for Joint Par-
ticipation in the National Center for Toxico-
logical Research, April 1, 1971. 1367
4.1d Memorandum of Agreement Between the United
States Environmental Protection Agency and the
United States Department of Agriculture, June
14, 1972. 1370
4.1e Interagency Agreement Between the Depart-
ment of Agriculture and the Environmental Pro-
tection Agency, Jan. 23, 1973 1372
4.2 Selected Reports 1376
4.2a The President's Science Advisory Committee Re-
port on Pesticides, May 14, 1963 1376
4.2b Deficiencies in Administration of Federal Insec-
ticide, Fungicide, and Rodenticide Act, House
Committee on Government Operations, H.R.
REP. No. 91-637, 91st Cong., 1st Sess. (1969).-- 1402
4.2c Report on 2, 4, 5-T, A Report of the Panel on
Herbicides of the President's Science Advisory
Committee, March 1971 1495
-------
STATUTES AND LEGISLATIVE HISTORY 1043
1.12c (3) CONGRESSIONAL RECORD
1.12c (3) (a) VOL. 93 (1947), July 7: Amended and passed House,
p. 8392
[No Relevant Discussion on Pertinent Section]
1.12c (3) (b) VOL. 94 (1948), June 21: Amended and passed Sen-
ate, p.7927
[No Relevant Discussion on Pertinent Section]
1.12c (3) (c) VOL. 94 (1948), June 16: House concurs in Senate
amendment, p. 8499
[No Relevant Discussion on Pertinent Section]
1.12d 1953 REORGANIZATION PLAN I, §§5, 8, 67 STAT. 631
Prepared by the President and transmitted to the Senate and the House of
Representatives in Congress assembled, March 12, 1953, pursuant to the
provisions of the Reorganization Act of 1949, approved June 20, 1949, as
amended.
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
[p.631]
SEC. 5. Transfers to the Department.—All functions of the
Federal Security Administrator are hereby transferred to the
Secretary. All agencies of the Federal Security Agency, together
with their respective functions, personnel, property, records, and
unexpended balances of appropriations, allocations, and other
funds (available or to be made available), and all other functions,
personnel, property, records, and unexpended balances of appro-
priations, allocations, and other funds (available or to be made
available) of the Federal Security Agency are hereby transferred
to the Department.
SEC. 8. Abolitions.—The Federal Security Agency (exclusive
of the agencies thereof transferred by section 5 of this reorgani-
zation plan), the offices of Federal Security Administrator and
Assistant Federal Security Administrator created by Reorgani-
zation Plan No. 1 (53 Stat. 1423), the two offices of assistant
heads of the Federal Security Agency created by Reorganization
Plan No. 2 of 1946 (60 Stat. 1095), and the office of Commissioner
for Social Security created by section 701 of the Social Security
Act, as amended (64 Stat. 558), are hereby abolished. The Secre-
tary shall make such provisions as may be necessary in order to
wind up any outstanding affairs of the Agency and offices abol-
-------
1044 LEGAL COMPILATION—PESTICIDES
ished by this section which are not otherwise provided for in this
reorganization plan.
[p. 632]
1.12e FEDERAL FOOD, DRUG, AND COSMETIC ACT AMEND-
MENTS OF 1954
April 15,1954, P.L. 83-335, §2, 68 Stat. 55
SEC. 2. Section 701 (e) of the Federal Food, Drug, and Cosmetic
Act is amended by striking out "401,".
1.12e (1) HOUSE COMMITTEE ON INTERSTATE AND FOR-
EIGN COMMERCE
H.R. REP. No. 934, 83rd Cong., 1st Sess. (1953)
AMENDING SECTIONS 401 AND 701 OF THE FEDERAL
FOOD, DRUG, AND COSMETIC ACT WITH RESPECT TO
ESTABLISHMENT OF FOOD STANDARDS
JULY 24, 1953.—Committed to the Committee of the Whole House on the State
of the Union and ordered to be printed
Mr. HALE, from the Committee on Interstate and Foreign
Commerce, submitted the following
REPORT
[To accompany H.R. 6434]
The Committee on Interstate and Foreign Commerce, to whom
was referred the bill (H.R. 6434) to amend sections 401 and 701
of the Federal Food, Drug, and Cosmetic Act so as to simplify the
procedures governing the establishment of food standards, having
considered the same, report favorably thereon without amendment
and recommend that the bill do pass.
PURPOSE OP THE LEGISLATION
The bill has a twofold purpose:
(1) To simplify the procedures governing the issuing,
amending, or repealing of regulations fixing and establishing
definitions and standards of identity, standards of quality, or
standards of fill of container, for foods as authorized by sec-
tion 401 of the Federal Food, Drug, and Cosmetic Act, by
restricting the requirements for the formal type of hearings,
as now prescribed in section 701 (e) of that act, to instances
where this procedure is desired by a party who would be
-------
STATUTES AND LEGISLATIVE HISTORY 1045
adversely affected if the regulation, as proposed, were to
become effective; and
(2) To enlarge the class of persons who as a matter of
right may petition the Secretary to act on a proposal to issue,
amend, or repeal, as the case may be, any such regulation.
[p. 1]
Section 2
Section 2 deletes "401" from present section 701 (e), thus ren-
dering the procedural requirements of that section inapplicable to
orders issued upon proposals published under section 401 (b) (1)
after enactment of this act.
*******
CHANGES IN EXISTING LAW
In compliance with clause 3 of rule XIII of the Rules of the
House of Representatives, changes in existing law made by the
bill, as introduced, are shown as follows (existing law proposed
to be omitted is enclosed in black brackets, new matter is printed
in italics, existing law in which no change is proposed is shown
in roman) :
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* ******
[p-4]
CHAPTER VII—GENERAL ADMINISTRATIVE PROVISIONS
REGULATIONS AND HEARINGS
SEC. 701. (a) * * *
*******
(e) The Secretary, on his own initiative or upon an application of any
interested industry or substantial portion thereof stating reasonable grounds
therefor, shall hold a public hearing upon a proposal to issue amend, or repeal
any regulation contemplated by any of the following sections of this Act:
[401,] 403 (j), 404 (a), 406 (a) and (b), 501 (b), 502 (d), 502 (h), 504, and
604. The Secretary shall give appropriate notice of the hearing, and the notice
shall set forth the proposal in general terms and specify the time and place
for a public hearing to be held thereon not less than thirty days after the
date of the notice, except that the public hearing on regulations under section
404 (a) may be held within a reasonable time, to be fixed by the Secretary,
after notice thereof. At the hearing any interested person may be heard in
[p. 5]
person or by his representative. As soon as practicable after completion of the
hearing, the Secretary shall by order make public his action in issuing,
amending, or repealing the regulation or determining not to take such action.
The Secretary shall base his order only on substantial evidence of record at
the hearing and shall set forth as part of the order detailed findings of fact
on which the order is based. No such order shall take effect prior to the
-------
1046 LEGAL COMPILATION—PESTICIDES
ninetieth day after it is issued, except that if the Secretary finds that
emergency conditions exist necessitating an earlier effective date, then the
Secretary shall specify in the order his findings as to such conditions and
the order shall take effect at such earlier date as the Secretary shall specify
therein to meet the emergency.
[p. 6]
1.12e (2) SENATE COMMITTEE ON LABOR AND PUBLIC
WELFARE
S. REP. No. 1060, 83rd Cong., 2d Sess. (1954)
AMENDING SECTIONS 401 AND 701 OF THE FEDERAL
FOOD, DRUG, AND COSMETIC ACT WITH RESPECT
TO ESTABLISHMENT OF FOOD STANDARDS
MARCH 9 (legislative day, March 1), 1954.—Ordered to be printed
Mr. PURTELL, from the Committee on Labor and Public Welfare,
submitted the following
REPORT
[To accompany H.R. 6434]
The Committee on Labor and Public Welfare, to whom was
referred the bill (H.R. 6434) to amend sections 401 and 701 of the
Federal Food, Drug, and Cosmetic Act so as to simplify the proce-
dures governing the establishment of food standards, having con-
sidered the same, report favorably thereon without amendment
and recommend that the bill do pass.
PURPOSE OF THE BILL
The main purpose of the bill is to facilitate the making of non-
controversial changes in food standards regulations. The bill is
designed to—
(1) Simplify the procedures governing the issuing, amend-
ing, or repealing of regulations fixing and establishing defini-
tions and standards of identity, standards of quality, or stan-
dards of fill of container for foods as authorized by section
401 of the Federal Food, Drug, and Cosmetic Act by restrict-
ing the requirements for the formal type of hearings, as now
prescribed in section 701 (e) of that act, to instances where
this procedure is desired by a party who would be adversely
affected if the regulation, as proposed, were to be effec-
tive ; and
(2) Enlarge the class of persons who as a matter of right
may petition the Secretary to act on a proposal to issue,
-------
STATUTES AND LEGISLATIVE HISTORY 1047
amend, or repeal, as the case may be, any such regulation.
The consensus of opinion among all the leading food producers,
as well as Food and Drug Administration officials, is that the exist-
ing standard-making procedures are slow and cumbersome. The
[p-1]
procedural requirements of the present law are unnecessarily
burdensome in that they require formal hearings and all that this
implies, whether a proposed regulation is controversial or not,
with the resultant useless expenditure of time and money by both
the Government and the interested industry, even when all are in
agreement as to the proposed regulation. Enactment of this bill
would provide needed relief from these unnecessary burdens by
eliminating the requirement for formal hearings except in instan-
ces where such a hearing is desired for the purpose of providing
a basis for the judicial review as now provided in the act, should
the objecting party find the ultimate regulation still objectionable.
The Commissioner of Food and Drugs, together with counsel
representing the interests of leading food producers, appeared
before members of the Subcommittee on Health of this committee
and strongly urged the early enactment of this legislation. All
communications received by the committee concerning this meas-
ure have been unanimous in favor of the bill's enactment and the
committee knows of no opposition thereto.
The Secretary of Health, Education, and Welfare, whose report
follows, as well as the Bureau of the Budget, endorse the bill and
recommend its enactment:
Hon. H. ALEXANDER SMITH,
Chairman, Committee on Labor and Public Welfare,
United States Senate, Washington 25, D.C.
DEAR MR. CHAIRMAN : This letter is in response to your request of August
3, 1953, for a report on H.R. 6434, a bill to amend section 401 and 701 of the
Federal Food, Drug, and Cosmetic Act so as to simplify the procedures
governing the establishment of food standards, as passed by the House of
Representatives.
This bill would provide for issuing, amending, or repealing food standards
regulations by a procedure comparable to that specified by section 507 (f) of
the act for regulations concerning the certification of certain antibiotic drugs.
This bill would greatly facilitate noncontroversial changes in food standards
regulations. It would eliminate the necessity for public hearings and the estab-
lishment of a record of testimony and exhibits where, after due notice, it
developed no one opposed the change. A further advantage would be to sim-
plify hearings on regulations containing both controversial and noncontrover-
sial issues by separating and eliminating the noncontroversial.
Experience in the establishment of food standards under authority of
section 401 demonstrates that the present procedures are cumbersome and
time-consuming, while experience in the promulgation of regulations under
-------
1048 LEGAL COMPILATION—PESTICIDES
section 507 (f) shows that the procedures of that section are simple, equitable,
and effective. Amendment of the law to simplify the food standards procedures
is highly desirable.
The present law requires the Secretary to hold hearings on proposals to
issue, amend, or repeal food standards upon application of an interested indus-
try or substantial portion thereof, stating reasonable grounds therefor. The
bill broadens this provision by requiring a hearing on petition of any interested
person, stating reasonable grounds. We regard this change as in the interest
of fairness and the development of improved technology in food production.
The House of Representatives made minor technical changes from the
original House bill, H.R. 5055, that are entirely acceptable to this Department.
This Department endorses this bill and recommends its enactment.
The Bureau of the Budget advises that it perceives no objection to the sub-
mission of this report to your committee.
Sincerely yours,
OVETA GULP HOBBY, Secretary.
[P-2]
Section 2
Section 2 deletes "401" from present section 701 (e), thus ren-
dering the procedural requirements of that section inapplicable
to orders issued upon proposals published under section 401 (b)
(1) after enactment of this act. [p. 4]
CHAPTER VII—GENERAL ADMINISTRATIVE PROVISIONS
REGULATIONS AND HEARINGS
SEC. 701. (a) * * *
*******
(e) The Secretary, on his own initiative or upon an application of any
interested industry or substantial portion thereof stating reasonable grounds
therefor, shall hold a public hearing upon a proposal to issue, amend, or repeal
any regulation contemplated by any of the following sections of this Act: [401,]
403 (j), 404 (a), 406 (a) and (b), 501 (b), 502 (d), 502 (h), 504, and 604. The
Secretary shall give appropriate notice of the hearing, and the notice shall set
forth the proposal in general terms and specify the time and place for a public
hearing to be held thereon not less than thirty days after the date of the notice,
except that the public hearing on regulations under section 404 (a) may be
held within a reasonable time, to be fixed by the Secretary, after notice thereof.
At the hearing any interested person may be heard in person or by his repre-
sentative. As soon as practicable after completion of the hearing, the Secre-
tary shall by order make public his action in issuing, amending, or repealing
[p. 5]
the regulation or determining not to take such action. The Secretary shall
base his order only on substantial evidence of record at the hearing and shall
set forth as part of the order detailed findings of fact on which the order is
based. No such order shall take effect prior to the ninetieth day after it is
issued, except that if the Secretary finds that emergency conditions exist
necessitating an earlier effective date, then the Secretary shall specify in the
order his findings as to such conditions and the order shall take effect at such
earlier date as the Secretary shall specify therein to meet the emergency.
[p. 6]
-------
STATUTES AND LEGISLATIVE HISTORY
1049
1.12e (3) CONGRESSIONAL RECORD
1.12e (3) (a) VOL. 991 (1953), July 30: Passed House, p. 10527
[No Relevant Discussion on Pertinent Section]
1.12e (3) (b) VOL. 100 (1954), April 5: Passed Senate, pp. 4556-
4557
Mr. PURTELL. Mr. President, the
main purpose of the bill is to facili-
tate the making of noncontroversial
changes in food standards regulations.
The bill is designed to—
First. Simplify the procedures gov-
erning the issuing, amending, or re-
pealing of regulations fixing and
establishing definitions and standards
of identity, standards of quality, or
standards of fill of container for foods
as authorized by section 401 of the Fed-
eral Food, Drug, and Cosmetic Act by
restricting the requirements for the
formal type of hearings, as now pre-
scribed in section 701 (e) of that act,
to instances where this procedure is
desired by a party who would be ad-
versely affected if the regulation, as
proposed, were to be effective; and
Second. Enlarge the class of persons
who as a matter of right may petition
the Secretary to act on a proposal to
issue, amend, or repeal, as the case
may be, any such regulation.
Actually, enactment of the bill will
do away with a great deal of unneces-
sary work which imposes not only addi-
tional cost, but also a loss of time on
petitioners and on the Food and Drug
administration. No objection at all to
the bill has been submitted to the com-
mittee; all witnesses who appeared at
the hearing were in favor of enact-
ment of the bill.
The Secretary of Health, Education,
and Welfare, who has submitted a re-
port on the bill — and the report is
printed in the hearings — and various
other persons endorse the bill and rec-
ommend its enactment.
*****
Mr. GORE. The distinguished Sena-
tor from Connecticut has made an able
explanation of the bill. Does he con-
sider it in the public interest that for-
mal hearings be waived, even though
no direct controversy is involved?
Would not it be in the public interest
to have available to the public the
reasons, formally stated, for such reg-
ulations?
Mr. PURTELL. Public hearings are
not to be waived, in the sense that
there are to be no public hearings,
when anyone at all objects to the pro-
posed regulations. The bill provides
that time for the filing of objections
will be allowed, and then a hearing will
be held before any such regulation on
the part of the Food and Drug Admin-
istration will become binding on the
public.
Mr. GORE. Mr. President, will the
Senator from Connecticut yield again
to me?
Mr. PURTELL. I yield.
Mr. GORE. It may be that our dif-
ference of opinion turns on the question
of what is and what is not a formal
hearing. What kind of hearing would
be held in case no controversy were in-
volved?
My point is that a person who applies
for a particular decision may well not
consider it controversial; but the pub-
lic interest may not be properly pro-
tected—and I stress my use of the word
"may" in that connection—unless the
public has knowledge of the facts and
unless a formal record is made of the
facts upon which the regulation is
made.
Mr. PURTELL. Of course, any regu-
lation will have to be worked out with
the interested parties, and then will be
published before it becomes effective.
Mr. BUTLER of Maryland. Mr.
President, will the Senator from Con-
necticut yield to me?
-------
1050
LEGAL COMPILATION—PESTICIDES
Mr. PURTELL. I yield.
Mr. BUTLER of Maryland. Does
the bill contain any provision for re-
course to the courts?
Mr. PURTELL. Oh, yes. It does not
change existing law in that respect at
all.
Mr. GORE. Mr. President, will the
Senator from Connecticut explain the
difference between the kind of hearing
to which he has alluded and the formal
type of hearing to which he has made
reference?
Mr. PURTELL. I shall be glad to do
so. I think perhaps it is better ex-
plained in the report, as compared with
any extemporaneous explanation I
might give.
I read now from the report:
EXPLANATION OP THE BILL BY SECTIONS
SECTION 1
This section amends section 401 of the Federal
Food, Drug, and Cosmetic Act by adding a new
subsection (b) prescribing the procedure for the
promulgation, under such section 401, of regu-
lations fixing and establishing definitions and
standards of identity, standards of quality, or
standards of fill of container for foods. It does
not change the present section 401 except that
it will now be designated as section 401 (a).
The procedural provisions of the proposed new
subsection (b) are divided into three subdivis-
ions providing respectively, for (1) the initiation
of action authorized by section 401 (a) and the
issuance of an order upon any published pro-
posal for such action ; (2) the filing of objections
by any person who will be adversely affected by
any order issued under (1) ; and (3) the formal
hearing on objections thus filed, the issuance of
an appropriate order following such hearing,
and the judicial review, as provided in section
701 (f) and (g), of any challenged order. A
more detailed explanation of these provisions
follows:
The action contemplated by section 401 (b)
(1) includes any action to issue, amend, or
repeal any regulation authorized by section 401
(a). This action may be initiated either by
publication of a proposal by the Secretary on
his own initiative or by filing of a petition by
any interested party submitting a proposal to
the Secretary for publication.
By allowing "any interested person" to peti-
tion for the issuance, amendment, or repeal of
any regulation authorized by section 401 (a),
the class of members of the food industry who
may file the petition as a matter of right has
been enlarged. The present law, section 701 (e),
provides that a hearing for the purpose of con-
sidering issuing, amending, or repealing a
regulation authorized by section 401 shall be
held "upon application of any interested indus-
try or a substantial portion thereof stating a
reasonable ground therefor." This language has
been construed as restricting those who may
apply for hearings as a matter of right to
the basic food manufacturers and food fabri-
cators. This provision has been unnecessarily
restrictive on other persons having a legitimate
and direct interest in the problems of food
standardization. For example, those who manu-
facture, or have manufactured for them, sub-
stances intended for use in processed or fabri-
cated foods may not, under the present law,
apply as a matter of right for a hearing to
consider the inclusion of their ingredient in a
standardized food. This situation will be cor-
rected by this change in language.
The present law, section 701 (e), requires that
a showing of "reasonable grounds" be made in
support of any application for a hearing. Since
the class of persons who may petition for action
by the Secretary on their proposal will be sub-
stantially enlarged, this requirement, which is
being included in the proposed sub&ection (b)
(1), assumes even greater significance and
should be( retained. Practical administration of
the law requires that there be a substantial
showing of merit for any proposed action.
Paragraph (2) of the new subsection (b)
provides for the filing of objections to any order
issued under (1), by any person who will be
adversely affected by such order. This refers, of
course, to the order acting on a published pro-
posal after a reasonable opportunity has been
afforded for presentation of views on the pro-
posed action. The Secretary's action denying a
petition filed with him as provided in (1) is not
an "order" within the meaning of this term as
used in any part of section 401 (b).
The filing of objections will operate to stay
the effectiveness of those provisions of the order
to which objection is made. In order that all
interested parties may be duly apprised of the
status of any order after the time for the filing
of objections has expired, the Secretary is re-
quired to publish a notice in the Federal Regis-
ter stating which provisions of the proposed
order as published are stayed and, when no
objections are filed, stating that fact.
Paragraph (3) of the new subsection (b)
prescribes the procedure for hearings on the
objections filed under paragraph (2) and, by
cross reference to section 701 (f) and (g)
incorporates these judicial review provisions so
that orders issued after hearing, as provided in
this paragraph, will remain subject to the same
judicial review provisions as those issued under
section 401 as at present in effect.
SECTION 2
Section 2 deletes "401" from present section
701 (e), thus rendering the procedural require-
ments of that section inapplicable to orders
issued upon proposals published under section
401 (b) (1) after enactment of this act.
-------
STATUTES AND LEGISLATIVE HISTORY
1051
SECTION 3
Section 3 relates to the question of the appli-
cability of the new procedure to matters which
may be pending before the Secretary at the time
of the enactment of this legislation. It provides
that in any case in which prior to the date of the
enactment of this legislation, a public hearing
has been begun, in accordance with section 701
[p. 4556]
(e) of the present law, upon a proposal for
issuance, amendment, or repeal of any regula-
tion contemplated by section 401, the provisions
of the present law as now in force shall be
applicable as though this legislation had not
been passed.
The PRESIDING OFFICER. Under
the 5-minute rule, the time available
to the Senator from Connecticut has
expired.
Mr. HENDRICKSON. Mr. Presi-
dent, I ask unanimous consent that the
Senator from Connecticut have 2 addi-
tional minutes.
The PRESIDING OFFICER. With-
out objection, it is so ordered.
Mr. PURTELL. Mr. President, I
hope the explanation I have given an-
swers the question of the Senator from
Tennessee.
Mr. GORE. Mr. President, will the
Senator from Connecticut yield again
tome?
Mr. PURTELL. I am glad to yield.
Mr. GORE. From the explanation
the Senator from Connecticut has
given, it seems clear that in case no
objection is filed to an application, no
record—that is to say, no stenographic
record or no record from the technical,
legal standpoint—will be made of the
hearing; but if objection is filed in
time, a formal hearing will be held.
Mr. PURTELL. That is correct.
Mr. GORE. Mr. President, I must
say that I have some doubt as to the
advisability of passing the bill. How-
ever, in view of the fact that the com-
mittee has reported it unanimously,
and particularly in view of the con-
sideration which the distinguished sen-
ior Senator from Connecticut has
given to this bill, and his approval of
it, I shall resolve the doubt in favor of
his position and withdraw my objec-
tion.
Mr. PURTELL. I certainly suggest
that if there is any doubt in the Sena-
tor's mind we should resolve such
doubt.
The PRESIDING OFFICER. (Mr.
UPTON in the chair). Is there objec-
tion to the present consideration of the
bill?
There being no objection, the bill
(H. R. 6434) to amend sections 401
and 701 of the Federal Food, Drug,
and Cosmetic Act so as to simplify the
procedures governing the establish-
ment of food standards was considered,
ordered to a third reading, read the
third time, and passed.
[p. 4557]
1.12f 1956 FEDERAL FOOD, DRUG, AND COSMETIC AMEND-
MENTS
August 1,1956, P.L. 84-905, §2, 70 Stat. 919
AN ACT
To amend sections 401 and 701 (e) of the Federal Food, Drug, and Cosmetic
Act so as to simplify the procedures governing the prescribing of regula-
tions under certain provisions of such Act, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, That section 401
of the Federal Food, Drug, and Cosmetic Act (21 U. S. C., sec.
341) is amended by striking out "(a)" where it appears after
"SEC. 401.", and subsection (b) of such section is repealed.
SEC. 2. Section 701 (e) of such Act (21 U.S.C., sec. 371 (e)) is
amended to read as follows:
-------
1052 LEGAL COMPILATION—PESTICIDES
"(e) (1) Any action for the issuance, amendment, or repeal of
any regulation under section 401, 403 (j),404 (a), 406 (a) or (b),
501 (b), 502 (d) or (h), 504, or 604, of this Act shall be begun by a
proposal made (A) by the Secretary on his own initiative, or (B) by
petition of any interested person, showing reasonable grounds
therefor, filed with the Secretary. The Secretary shall publish such
proposal and shall afford all interested persons an opportunity
to present their views thereon, orally or in writing. As soon as
practicable thereafter, the Secretary shall by order act upon such
proposal and shall make such order public. Except as provided in
paragraph (2), the order shall become effective at such time as
may be specified therein, but not prior to the day following the
last day on which objections may be filed under such paragraph.
"(2) On or before the thirtieth day after the date on which
an order entered under paragraph (1) is made public, any person
who will be adversely affected by such order if placed in effect may
file objections thereto with the Secretary, specifying with particu-
larity the provisions of the order deemed objectionable, stating the
grounds therefor, and requesting a public hearing upon such
objections. Until final action upon such objections is taken by
the Secretary under paragraph (3), the filing of such objections
shall operate to stay the effectiveness of those provisions of the
order to which the objections are made. As soon as practicable
after the time for filing objections has expired the Secretary shall
publish a notice in the Federal Register specifying those parts of
the order which have been stayed by the filing of objections and,
if no objections have been filed, stating that fact.
" (3) As soon as practicable after such request for a public hear-
ing, the Secretary, after due notice, shall hold such a public hear-
ing for the purpose of receiving evidence relevant and material to
the issues raised by such objections. At the hearing, any interested
person may be heard in person or by representative. As soon as
practicable after completion of the hearing, the Secretary shall by
order act upon such objections and make such order public. Such
order shall be based only on substantial evidence of record at such
hearing and shall set forth, as part of the order, detailed findings
of fact on which the order is based. The Secretary shall specify in
the order the date on which it shall take effect, except that it shall
not be made to take effect prior to the ninetieth day after its publi-
cation unless the Secretary finds that emergency conditions exist
necessitating an earlier effective date, in which event the Secretary
shall specify in the order his findings as to such conditions."
[p.919]
-------
STATUTES AND LEGISLATIVE HISTORY 1053
1.12f (1) HOUSE COMMITTEE ON INTERSTATE AND FOR-
EIGN COMMERCE
H.R. REP. No. 2623, 84th Cong., 2d Sess. (1956)
AMENDING THE FEDERAL FOOD, DRUG, AND COSMETIC
ACT TO SIMPLIFY PROCEDURES GOVERNING THE PRE-
SCRIBING OF REGULATIONS UNDER CERTAIN
PROVISIONS OF SUCH ACT
JULY 5,1956.—Committed to the Committee of the Whole House on the State
of the Union and ordered to be printed
Mr. PRIEST, from the Committee on Interstate and Foreign
Commerce, submitted the following
REPORT
[To accompany H.R. 9547]
The Committee on Interstate and Foreign Commerce, to whom
was referred the bill (H.R. 9547) to amend section 701 of the
Federal Food, Drug, and Cosmetic Act so as to simplify the pro-
cedures governing the prescribing of regulations under certain
provisions of such act, and for other purposes, having considered
the same, report favorably thereon with an amendment and rec-
ommend that the bill as amended do pass.
The amendment is as follows:
Amend the title so as to read:
A bill to amend sections 401 and 701 (e) of the Federal
Food, Drug, and Cosmetic Act so as to simplify the procedures
governing the prescribing of regulations under certain pro-
visions of such Act, and for other purposes.
PURPOSE OF LEGISLATION
The purpose of the bill is to simplify the procedures followed by
the Food and Drug Administration in making regulations under
certain provisions of the Federal Food, Drug, and Cosmetic Act.
The bill would remove in specified situations, where the proposed
regulations are not controversial, the mandatory requirement of
following formal rulemaking procedures.
The legislation would extend the procedural simplification pro-
visions of Public Law 335, 83d Congres^. Public Law 335 was
limited in its application to regulations establishing standards of
identity, standards of quality, or standards of fill of container,
for food products. The experience under Public Law 335 has been
[p.l]
-------
1054 LEGAL COMPILATION—PESTICIDES
so gratifying to both industry and government that all concerned
desire to have this simplified procedure apply to all regulatory pro-
cedures referred to in section 701 of the Federal Food, Drug, and
Cosmetic Act. These include labeling for special dietary foods,
tolerances for necessary and unavoidable poisonous and deleteri-
ous substances in foods, listing of coal-tar colors which may be
certified for use in food, drugs, and cosmetics, and other provi-
sions calling for rulemaking by the Food and Drug Administration.
The procedural requirements of the present law are unnecessar-
ily burdensome. They require formal hearings, whether a proposed
regulation is controversial or not. This results in useless expendi-
tures of time and money by both the Government and the interested
industry.
The Subcommittee on Health and Science held hearings on this
legislation, in the course of which the sponsor of the bill, a repre-
sentative of the Department of Health, Education, and Welfare,
and the chairman of the legislative committee of the food, drug,
and cosmetic law section of the New York State Bar Association
testified in favor of this bill. The committee knows of no opposi-
tion to this legislation.
The reports of the Departments of Health, Education, and Wel-
fare, and Justice, and the Executive Office of the President support
the proposed legislation, and read as follows:
DEPARTMENT OF HEALTH,
EDUCATION, AND WELFARE,
June 6, 1956.
HON. J. PERCY PRIEST,
Chairman, Committee on Interstate and Foreign Commerce,
House of Representatives, Washington $5, D. C.
DEAR MR. CHAIRMAN: This is in response to your request of March 1, 1956,
for a report on H. R. 9547, a bill to amend section 701 of the Federal Food,
Drug, and Cosmetic Act so as to simplify the procedure governing the pre-
scribing of regulations under certain provisions of such act, and for other
purposes.
This bill would extend the procedural simplification provisions of Public
Law 335, 83d Congress, 2d session, by removing the requirements of formal
rulemaking—public hearing, and establishment of a record of testimony and
exhibits on which to base a decision—with respect to certain regulations in
cases where the regulation, or amendment or repeal of the regulation, is non-
controversial. The regulations concerned are those dealing with labeling for
special dietary foods (sec. 403 (j)), emergency permit control (sec. 404), toler-
ances for necessary and unavoidable poisonous and deleterious substances
in foods (sec. 406 (a)), listing of coal-tar colors which may be certified for
use in food, drugs and cosmetics (sees. 406 (b), 504, and 604), modification
of tests and assays prescribed in official compendia or prescribing tests for
official drugs where the compendia have no prescribed tests (sec. 501 (b)),
-------
STATUTES AND LEGISLATIVE HISTORY 1055
listing of chemical derivatives of habit-forming drugs (sec. 502 (d)), and
packaging requirements and labeling precautions for drugs liable to dete-
rioration (sec. 502 (h)).
The bill would greatly facilitate the establishment of regulations insofar
as they are noncontroversial. It would also simplify hearings on regulations
containing both controversial and noncontroversial issues by separating and
[p. 2]
eliminating the noncontroversial. On the narrow issues about which there is
controversy, any interested person affected by a proposed regulation could,
by filing a petition, initiate the formal procedure, including a public hear-
ing, establishment of the public record on which our action would be based,
and review of our action in the United States Courts of Appeals. Thus, no
substantial rights of any person would be relieved of protection, while govern-
ment, the public, and industry are relieved of the costs and expenditure of
time in holding hearings on points about which all agree.
Experience with Public Law 335, which was limited to regulations estab-
lishing standards of identity, quality, and fill of container for food prod-
ucts, has shown that it provides an effective procedure for establishing regu-
lations with a minimum of cost and wasted effort, while at the same time
protecting the rights of interested persons.
Your committee's report on H.R. 6434 (which becomes Public Law 335)
stated in regard to the proposal to simplify the procedure for food standards
issued under section 401 of the act:
"All of the communications received by the committee, including many not
a part of the record, and both of the witnesses appearing before the committee,
favored the proposed legislation and urged its early enactment. There is no
known opposition.
"The consensus of opinion as expressed in these communications and by
witnesses appearing before the committee may be fairly stated to be that (a)
the procedural requirements of the present law are unnecessarily burden-
some in that they require formal hearings and all that this implies, whether
a proposed regulation is controversial or not, with the resultant useless expen-
diture of time and money by both the Government and the interested indus-
try, even when all are in agreement as to the proposed regulation; and (6)
the proposed legislation is favored by them because it should provide the
needed relief from these unnecessary burdens by eliminating the requirement
for formal hearings except in instances where such a hearing is desired for
the purpose of providing a basis for the judicial review as now provided in
the act, should the objecting party find the ultimate regulation still objection-
able (H. Kept. 934, 83d Cong., 1st sess.)."
We believe that the amendment of section 701 (e) contained in the bill,
which makes the simplification effected by Public Law 335 applicable to the
procedure for the other regulations governed by section 701 (e), will prove
as noncontroversial in its extension to other regulations as was the prior
amendment affecting only the food standards procedure.
The existing law is unnecessarily burdensome, and the proposed bill would
afford the required relief. We recommend that it be considered favorably by
your committee.
We have also prepared and submitted to the President of the Senate an
identical draft bill, with a request that it be considered by the appropriate
committee of the Senate. A copy of our letter of transmittal of the draft bill
is enclosed for your convenience.
-------
1056 LEGAL COMPILATION—PESTICIDES
The Bureau of the Budget advises that it perceives no objection to the sub-
mission of this report to your committee.
Sincerely yours,
M. B. FOLSOM, Secretary.
[p. 3]
EXECUTIVE OFFICE OF THE PRESIDENT,
BUREAU OF THE BUDGET,
Washington 25, D. C., May 7,1956.
HON. J. PERCY PRIEST,
Chairman, Committee on Interstate and Foreign Commerce,
House of Representatives, Washington 25, D. C.
MY DEAR MR. CHAIRMAN: This is in reply to your letter of March 1, 1956,
requesting the views of the Bureau of the Budget on H.R. 9547, to amend
section 701 of the Federal Food, Drug, and Cosmetic Act so as to simplify
the procedures governing the prescribing of regulations under certain pro-
visions of such act, and for other purposes.
This bill would extend to eight additional sections of the Federal Food,
Drug, and Cosmetic Act the simplified procedures which have proven work-
able on a more limited scale under the recently enacted Hale amendment.
Under this simplified procedure the holding of a hearing prior to the making
or changing of a rule is eliminated as a condition precedent to rulemaking,
when the proposed rule is not in controversy. From the point of view of the
best utilization of scarce legal and other enforcement personnel of the Food
and Drug Administration, this bill would represent a change for the better.
Furthermore, the Department of Health, Education, and Welfare asserts
that no substantial rights of any persons would be jeopardized by this sim-
plified procedure, inasmuch as the bill provides for the right to a full and
impartial hearing upon petition by any person who feels that he would be
adversely affected by a proposed rule.
This office would have no objection to the enactment of this measure.
Sincerely yours,
ROBERT E. MERBIAM,
Assistant to the Director.
DEPARTMENT OF JUSTICE,
May U, 1956.
HON. J. PERCY PRIEST,
Chairman, Committee on Interstate and Foreign Commerce,
House of Representatives, Washington, D. C.
DEAR MR. CHAIRMAN: This is in response to your request for the views of
the Department of Justice concerning the bill (H.R. 9547) to amend section
701 of the Federal Food, Drug, and Cosmetic Act so as to simplify the proce-
dures governing the prescribing of regulations under certain provisions
of such act, and for other purposes.
The purpose of the bill would be accomplished by eliminating the present
requirement of the Federal Food, Drug, and Cosmetic Act that hearings be
conducted in certain cases although no controversy exists.
-------
STATUTES AND LEGISLATIVE HISTORY 1057
The act now provides for two separate procedures pertaining to the issu-
ance of regulations. Section 401 (b) relates to regulations pertaining to
standards of identity, quality, and fill of containers for food. Section 701 (e)
relates to regulations issued pursuant to eight other sections of the act.
Under this latter provision a public hearing is required as a condition prece-
dent to the issuance, amendment, or repeal of any regulation covered. Under
section 401 (b) a public hearing need be held only when requested by a person
adversely affected by a proposed rulemaking action.
[P. 4]
The bill would establish a uniform procedure for the issuance of regulations
under the listed sections, and would adopt the provisions of section 401 (b)
with respect to public hearings as applicable to all of the sections.
The Department of Justice would have no objection to the enactment of
this legislation.
The Bureau of the Budget has advised that there is no objection to the sub-
mission of this report.
Sincerely,
WILLIAM P. ROGERS,
Deputy Attorney General.
CHANGES IN EXISTING LAW
In compliance with clause 3 of rule XIII of the Rules of the
House of Representatives, changes in existing law made by the bill,
as introduced, are shown as follows (existing law proposed to be
omitted is enclosed in black brackets, new matter is printed in
italics, existing law in which no change is proposed is shown in
roman) :
SECTIONS 401 AND 701 (e) OF THE FEDERAL
FOOD, DRUG, AND COSMETIC ACT
CHAPTER IV—FOOD
DEFINITIONS AND STANDARDS FOR FOOD
SEC. 401 [ (a) ] Whenever in the judgment of the Secretary such
action will promote honesty and fair dealing in the interest of con-
sumers, he shall promulgate regulations fixing and establishing
for any food, under its common or usual name so far as practicable,
a reasonable definition and standard of identity, a reasonable stan-
dard of quality, and/or reasonable standards of fill of container:
Provided, That no definition and standard of identity and no stan-
dard of quality shall be established for fresh or dried fruits, fresh
or dried vegetables, or butter, except that definitions and standards
of identity may be established for avocados, cantaloupes, citrus
fruits, and melons. In prescribing any standard of fill of container,
the Secretary shall give due consideration to the natural shrinkage
in storage and in transit of fresh natural food and to need for the
necessary packing and protective material. In the prescribing of
-------
1058 LEGAL COMPILATION—PESTICIDES
any standard of quality for any canned fruit or canned vegetable,
consideration shall be given and due allowance made for the differ-
ing characteristics of the several varieties of such fruit or vege-
table. In prescribing a definition and standard of identity for any
food or class of food in which optional ingredients are permitted,
the Secretary shall, for the purpose of promoting honesty and fair
dealing in the interest of consumers, designate the optional ingre-
dients which shall be named on the label. Any definition and stan-
dard of identity prescribed by the Secretary for avocados, canta-
loupes, citrus fruits, or melons shall relate only to maturity and to
the effects of freezing. , --.
[p. 5]
[(b) (1) Any action under subsection (a) for the issuance,
amendment, or repeal of any regulation shall be begun by a pro-
posal made (A) by the Secretary of his own initiative, or (B) by
petition of any interested person, showing reasonable grounds
therefor, filed with the Secretary. The Secretary shall publish such
proposal and shall afford all interested persons an opportunity to
present their views thereon, orally or in writing. As soon as prac-
ticable thereafter, the Secretary shall by order act upon such pro-
posal and shall make such order public. Except as provided in para-
graph (2), the order shall become effective at such time as may
be specified therein, but not prior to the day following the last day
on which objections may be filed under such paragraph.
[ (2) At any time prior to the thirtieth day after the date on
which an order entered under paragraph (1) is made public, any
person who will be adversely affected by such order if placed in
effect may file objections thereto with the Secretary, specifying
with particularity the provisions of the order deemed objection-
able, stating the grounds therefor, and requesting a public hearing
upon such objections. Until final action upon such objections is
taken by the Secretary under paragraph (3), the filing of such
objections shall operate to stay the effectiveness of those provisions
of the order to which the objections are made. As soon as practi-
cable after the time for filing objections has expired the Secretary
shall publish a notice in the Federal Register specifying those parts
of the order which have been stayed by the filing of objections and,
if no objections have been filed, stating that fact.
[ (3) As soon as practicable after such request for a public hear-
ing, the Secretary, after due notice, shall hold such a public hearing
for the purpose of receiving evidence relevant and material to the
issues raised by such objections. At the hearing, any interested
person may be heard in person or by representative. As soon as
practicable after completion of the hearing, the Secretary shall by
-------
STATUTES AND LEGISLATIVE HISTORY 1059
order act upon such objections and make such order public. Such
order shall be based only on substantial evidence of record at such
hearing and shall set forth, as part of the order, detailed findings
of fact on which the order is based. The Secretary shall specify in
the order the date on which it shall take effect, except that it shall
not be made to take effect prior to the ninetieth day after its pub-
lication unless the Secretary finds that emergency conditions exist
necessitating an earlier effective date, in which event the Secretary
shall specify in the order his findings as to such conditions. Such
order shall be subject to the provisions of section 701 (f) and (g).]
*******
CHAPTER VII—GENERAL ADMINISTRATIVE PROVISIONS
REGULATIONS AND HEARINGS
Sec. 701. (a) * * *
*******
[ (e) The Secretary, on his own initiative or upon an applica-
tion of any interested industry or substantial portion thereof stat-
ing reasonable grounds therefor, shall hold a public hearing upon
[p. 6]
a proposal to issue, amend, or repeal any regulation contemplated
by any of the following sections of this Act: 403 (j), 404 (a),
406 (a) and (b), 501 (b), 502 (d), 502 (h), 504, and 604. The
Secretary shall give appropriate notice of the hearing, and the
notice shall set forth the proposal in general terms and specify the
time and place for a public hearing to be held thereon not less than
thirty days after the date of the notice, except that the public
hearing on regulations under section 404 (a) may be held within
a reasonable time, to be fixed by the Secretary, after notice thereof.
At the hearing any interested person may be heard in person or by
his representative. As soon as practicable after completion of the
hearing, the Secretary shall by order make public his action in issu-
ing, amending, or repealing the regulation or determining not to
take such action. The Secretary shall base his order only on sub-
stantial evidence of record at the hearing and shall set forth as
part of the order detailed findings of fact on which the order is
based. No such order shall take effect prior to the ninetieth day
after it is issued, except that if the Secretary finds that emergency
conditions exist necessitating an earlier effective date, then the
Secretary shall specify in the order his findings as to such condi-
tions and the order shall take effect at such earlier date as the Sec-
retary shall specify therein to meet the emergency.]
(e) (1) Any action for the issuance, amendment, or repeal of any
-------
1060 LEGAL COMPILATION—PESTICIDES
regulation under section 401, 403 (j), 404 (a), 406 (a) or (b), 501
(b), 502 (d) or (h), 504, or 604, of this Act shall be begun by a pro-
posal made (A) by the Secretary on his own initiative, or (B) by
petition of any interested person, showing reasonable grounds
therefor, filed with the Secretary. The Secretary shall publish such
proposal and shall afford all interested persons an oppportunity
to present their views thereon, orally or in writing. As soon as
practicable thereafter, the Secretary shall by order act upon such
proposal and shall make such order public. Except as provided in
paragraph (2), the order shall become effective at such time as
may be specified therein, but not prior to the day following the
last day on which objections may be filed under such paragraph.
(2) On or before the thirtieth day after the date on which an
order entered under paragraph (1) is made public, any person who
will be adversely affected by such order if placed in effect may file
objections thereto with the Secretary, specifying with particular-
ity the provisions of the order deemed objectionable, stating the
grounds therefor, and requesting a public hearing upon such objec-
tions. Until final action upon such objections is taken by the Secre-
tary under paragraph (3), the filing of such objections shall oper-
ate to stay the effectiveness of those provisions of the order to
which the objections are made. As soon as practicable after the
time for filing objections has expired the Secretary shall publish
a notice in the Federal Register specifying those parts of the order
which have been stayed by the filing of objections and, if no objec-
tions have been filed, stating that fact.
(3) As soon as practicable after such request for a public hear-
ing, the Secretary, after due notice, shall hold such a public hearing
for the purpose of receiving evidence relevant and material to the
issues raised by such objections. At the hearing, any interested
person may be heard in person or by representative. As soon as
practicable after completion of the hearing, the Secretary shall by
[p. 7]
order act upon such objections and make such order public. Such
order shall be based only on substantial evidence of record at such
hearing and shall set forth, as part of the order, detailed findings
of fact on which the order is based. The Secretary shall specify in
the order the date on which it shall take effect, except that it shall
not be made to take effect prior to the ninetieth day after its pub-
lication unless the Secretary finds that emergency conditions exist
necessitating an earlier effective date, in which event the Secretary
shatt specify in the order his findings as to such conditions.
[P. 8]
-------
STATUTES AND LEGISLATIVE HISTORY 1061
1.12f (2) SENATE COMMITTEE ON LABOR AND PUBLIC
WELFARE
S. REP. No. 2752, 84th Cong., 2d Sess. (1956)
AMENDING THE FEDERAL FOOD, DRUG, AND COSMETIC
ACT TO SIMPLIFY PROCEDURES GOVERNING THE
PRESCRIBING OF REGULATIONS UNDER CERTAIN
PROVISIONS OF SUCH ACT
JULY 21 (legislative day, July 16), 1956.—Ordered to be printed
Filed under authority of the order of the Senate of July 21 (legislative day,
July 16), 1956
Mr. MURRAY, from the Committee on Labor and Public Welfare,
submitted the following
REPORT
[To accompany H.R. 9547]
The Committee on Labor and Public Welfare, to whom was
referred the bill (H.R. 9547) to amend section 701 of the Federal
Food, Drug, and Cosmetic Act so as to simplify the procedures
governing the prescribing of regulations under certain provisions
of such act, and for other purposes, having considered the same,
report favorably thereon without amendment and recommend that
the bill do pass.
PURPOSE OF LEGISLATION
The purpose of the bill is to simplify the procedures followed by
the Food and Drug Administration in making regulations under
certain provisions of the Federal Food, Drug, and Cosmetic Act.
The bill would remove in specified situations, where the proposed
regulations are not controversial, the mandatory requirement of
following formal rulemaking procedures.
The legislation would extend the procedural simplification pro-
visions of Public Law 335, 83d Congress. Public Law 335 was lim-
ited in its application to regulations establishing standards of iden-
tity, standards of quality, or standards of fill of container, for food
products. The experience under Public Law 335 has been so grati-
fying to both industry and government that all concerned desire
to have this simplified procedure apply to all regulatory procedures
referred to in section 701 of the Federal Food, Drug, and Cosmetic
Act. These include labeling for special dietary foods, tolerances
for necessary and unavoidable poisonous and deleterious sub-
stances in foods, listing of coal-tar colors which may be certified
-------
1062 LEGAL COMPILATION—PESTICIDES
for use in food, drugs, and cosmetics, and other provisions calling
[P.I]
for rulemaking by the Food and Drug Administration.
The procedural requirements of the present law are unneces-
sarily burdensome. They require formal hearings, whether a pro-
posed regulation is controversial or not. This results in useless
expenditures of time and money by both the Government and the
interested industry.
The Subcommittee on Health and Science of the Committee on
Interstate and Foreign Commerce in the House of Representatives
held hearings on this legislation, in the course of which the sponsor
of the bill, a representative of the Department of Health, Educa-
tion, and Welfare, and the chairman of the legislative committee
of the food, drug, and cosmetic law section of the New York State
Bar Association testified in favor of this bill.
The committee knows of no opposition to this legislation.
The reports submitted to the House Committee by the Depart-
ments of Health, Education, and Welfare, and Justice, and the
Executive Office of the President support the proposed legislation,
and read as follows: r on
Lp. 2]
CHANGES IN EXISTING LAW
In compliance with subsection (4) of rule XXIX of the Standing
Rules of the Senate, changes in existing law made by the bill, as
reported, are shown as follows (existing law proposed to be omit-
ted is enclosed in black brackets, new matter is printed in italics,
existing law in which no change is proposed is shown in roman) :
SECTIONS 401 AND 701 (e) OF THE FEDERAL FOOD,
DRUG, AND COSMETIC ACT
CHAPTER IV—FOOD
DEFINITIONS AND STANDARDS FOR FOOD
SEC. 401. [ (a) ] Whenever in the judgment of the Secretary such
action will promote honesty and fair dealing in the interest of con-
sumers, he shall promulgate regulations fixing and establishing for
any food, under its common or usual name so far as practicable, a
reasonable definition and standard of identity, a reasonable stan-
dard of quality, and/or reasonable standards of fill of container:
Provided, That no definition and standard of identity and no stan-
dard of quality shall be established for fresh or dried fruits, fresh
or dried vegetables, or butter, except that definitions and stan-
dards of identity may be established for avocados, cantaloupes,
citrus fruits, and melons. In prescribing any standard of fill of con-
-------
STATUTES AND LEGISLATIVE HISTORY 1063
tainer, the Secretary shall give due consideration to the natural
shrinkage in storage and in transit of fresh natural food and to
need for the necessary packing and protective material. In the
prescribing of any standard of quality for any canned fruit or
canned vegetable, consideration shall be given and due allowance
made for the differing characteristics of the several varieties of
such fruit or vegetable. In prescribing a definition and standard
of identity for any food or class of food in which optional ingredi-
ents are permitted, the Secretary shall, for the purpose of promot-
ing honesty and fair dealing in the interest of consumers, desig-
nate the optional ingredients which shall be named on the label.
Any definition and standard of identity prescribed by the Secre-
tary for avocados, cantaloupes, citrus fruits, or melons shall relate
only to maturity and to the effects of freezing.
[(b) (1) Any action under subsection (a) for the issuance,
amendment, or repeal of any regulation shall be begun by a pro-
posal made (A) by the Secretary of his own initiative, or (B) by
petition of any interested person, showing reasonable grounds
therefor, filed with the .- ,.-.
Secretary. The Secretary shall publish such proposal and shall
afford all interested persons an opportunity to present their
views thereon, orally or in writing. As soon as practicable there-
after, the Secretary shall by order act upon such proposal and
shall make such order public. Except as provided in paragraph
(2), the order shall become effective at such time as may be
specified therein, but not prior to the day following the last day
on which objections may be filed under such paragraph.
[(2) At any time prior to the thirtieth day after the date on
which an order entered under paragraph (1) is made public, any
person who will be adversely affected by such order if placed in
effect may file objections thereto with the Secretary, specifying
with particularity the provisions of the order deemed objection-
able, stating the grounds therefor, and requesting a public hearing
upon such objections. Until final action upon such objections is
taken by the Secretary under paragraph (3), the filing of such
objections shall operate to stay the effectiveness of those provi-
sions of the order to which the objections are made. As soon as
practicable after the time for filing objections has expired, the
Secretary shall publish a notice in the Federal Register specifying
those parts of the order which have been stayed by the filing of
objections and, if no objections have been filed, stating that fact.
[ (3) As soon as practicable after such request for a public hear-
ing, the Secretary, after due notice, shall hold such a public hear-
-------
1064 LEGAL COMPILATION—PESTICIDES
ing for the purpose of receiving evidence relevant and material to
the issues raised by such objections. At the hearing, any interested
person may be heard in person or by representative. As soon as
practicable after completion of the hearing, the Secretary shall
by order act upon such objections and make such order public.
Such order shall be based only on substantial evidence of record
at such hearing and shall set forth, as part of the order, detailed
findings of fact on which the order is based. The Secretary shall
specify in the order the date on which it shall take effect, except
that it shall not be made to take effect prior to the ninetieth day
after its publication unless the Secretary finds that emergency
conditions exist necessitating an earlier effective date, in which
event the Secretary shall specify in the order his findings as to
such conditions. Such order shall b° subject to the provisions of
section701 (f) and (g).]
CHAPTER VII—GENERAL ADMINISTRATIVE PROVISIONS
REGULATIONS AND HEARINGS
SEC. 701. (a) * * *
*******
[(e) The Secretary, on his own initiative or upon an applica-
tion of any interested industry or substantial portion thereof stat-
ing reasonable grounds therefor, shall hold a public hearing upon a
proposal to issue, amend, or repeal any regulation contemplated
by any of the following sections of this Act: 403 (j), 404 (a),
406 (a) and (b), 501 (b), 502 (d), 502 (h), 504, and 604. The
Secretary shall give appropriate notice of the hearing, and the
notice shall set forth the proposal in general terms and specify
the time and place for a public hearing to be held thereon not less
[p. 6]
than thirty days after the date of the notice, except that the public
hearing on regulations under section 404 (a) may be held within
a reasonable time, to be fixed by the Secretary, after notice there-
of. At the hearing any interested person may be heard in person
or by his representative. As soon as practicable after completion
of the hearing, the Secretary shall by order make public his action
in issuing, amending, or repealing the regulation or determining
not to take such action. The Secretary shall base his order only on
substantial evidence of record at the hearing and shall set forth
as part of the order detailed findings of fact on which the order is
based. No such order shall take effect prior to the ninetieth day
after it is issued, except that if the Secretary finds that emergency
conditions exist necessitating an earlier effective date, then the
-------
STATUTES AND LEGISLATIVE HISTORY 1065
Secretary shall specify in the order his findings as to such condi-
tions and the order shall take effect at such earlier date as the
Secretary shall specify therein to meet the emergency.]
(e) (1) Any action for the issuance, amendment, or repeal of
any regulation under section 401, 403 (j), 404 (a), 406 (a) or (b),
501 (b), 502 (d) or (h), 504, or 604, of this Act shall be begun by
a proposal made (A) by the Secretary on his own initiative, or (B)
by petition of any interested person, showing reasonable grounds
therefor, filed with the Secretary. The Secretary shall publish such
proposal and shall afford all interested persons an opportunity to
present their views thereon, orally or in writing. As soon as
practicable thereafter, the Secretary shall by order act upon such
proposal and shall make such order public. Except as provided in
paragraph (2), the order shall become effective at such time as
may be specified therein, but not prior to the day following the last
day on which objections may be filed under such paragraph.
(2) On or before the thirtieth day after the date on which an
order entered under paragraph (1) is made public, any person who
will be adversely affected by such order if placed in effect may file
objections thereto with the Secretary, specifying with particularity
the provisions of the order deemed objectionable, stating the
grounds therefor, and requesting a public hearing upon such
objections. Until final action upon such objections is taken by the
Secretary under paragraph (3), the filing of such objections shall
operate to stay the effectiveness of those provisions of the order to
which the objections are made. As soon as practicable after the
time for filing objections has expired the Secretary shall publish
a notice in the Federal Register specifying those parts of the order
which have been stayed by the filing of objections and, if no objec-
tions have been filed, stating that fact.
(3) As soon as practicable after such request for a public hear-
ing, the Secretary, after due notice, shall hold such a public hearing
for the purpose of receiving evidence relevant and material to the
issues raised by such objections. At the hearing, any interested
persons may be heard in person or by representative. As soon as
practicable after completion of the hearing, the Secretary shall by
order act upon such objections and make such order public. Such
order shall be based only on substantial evidence of record at such
hearing and shall set forth, as part of the order, detailed findings
of fact on which the order is based. The Secretary shall specify in
the order the date on which it shall take effect, except that it shall
not be made to take effect prior to the ninetieth day after its publi-
cation unless the Secretary finds that emergency conditions exist
-------
1066 LEGAL COMPILATION—PESTICIDES
necessitating an earlier effective date, in which event the Secretary
shall specify in the order his findings as to such conditions.
[p. 7]
1.12f (3) CONGRESSIONAL RECORD, VOL. 102 (1956)
1.12f (3) (a) July 16: Passed House, pp. 12911-12912
[No Relevant Discussion on Pertinent Section]
1.12f (3) (b) July 23: Passed Senate, p. 13923
[No Relevant Discussion on Pertinent Section]
1.12g ABBREVIATED RECORDS ON REVIEW ACT
August 28,1958, P.L. 85-791, §21, 72 Stat. 948
SEC. 21. (a) The second and third sentences of paragraph (1)
of subsection (f) of section 701 of the Federal Food, Drug, and
Cosmetic Act (52 Stat. 1055), as amended, are amended to read as
follows: "A copy of the petition shall be forthwith transmitted by
the clerk of the court to the Secretary or other officer designated by
him for that purpose. The Secretary thereupon shall file in the
court the record of the proceedings on which the Secretary based
his order, as provided in section 2112 of title 28, United States
Code."
(b) The first sentence of paragraph (3) of subsection (f) of
section 701 of the Federal Food, Drug, and Cosmetic Act (52 Stat.
1055), as amended, is amended to read as follows: "Upon the
filing of the petition referred to in paragraph (1) of this subsec-
tion, the court shall have jurisdiction to affirm the order, or to set
it aside in whole or in part, temporarily or permanently."
[p. 948]
1.12g (1) HOUSE COMMITTEE ON THE JUDICIARY
H.R. REP. No. 842, 85th Cong., 1st Sess. (1957)
AUTHORIZING ABBREVIATED RECORDS IN REVIEWING
ADMINISTRATIVE AGENCY PROCEEDINGS
JULY 23,1957.—Ordered to be printed
Mr. WlLUS, from the Committee on the Judiciary, submitted the
following
REPORT
[To accompany H.R. 6788]
The Committee on the Judiciary, to whom was referred the bill
(H.R. 6788) to authorize the abbreviation of the record on the
-------
STATUTES AND LEGISLATIVE HISTORY 1067
review or enforcement of orders of administrative agencies by the
courts of appeals and the review or enforcement of such orders on
the original papers and to make uniform the law relating to the
record on review or enforcement of such orders, and for other
purposes, having considered the same, report favorably thereon
with amendments and recommend that the bill do pass.
The amendments are as follows:
*******
[P.I]
PURPOSE
The purpose of the bill is to permit the several courts of appeals
to adopt rules authorizing the abbreviation of the transcript and
other parts of the record made before Federal administrative
agencies when the orders of those agencies are to be reviewed by
the courts of appeals.
In many instances much of the record made before such agencies
is not relevant to the questions actually raised on appeal. This legis-
lation, in permitting an abbreviated record to be transmitted,
should result in a substantial saving of time and money without
interfering with any of the appellate rights which persons now
have under existing law.
[p. 6]
Sections 3 to 33 contain provisions which make changes to pres-
ent law. For the most part those changes are to conform the present
provisions of law to section 2 of the bill and are explained in
another part of this report under "Explanation of amendments".
The agencies, boards, commissions or offices whose orders are to be
reviewable under the statutes proposed to be amended by sections 3
to 34 of the bill are the following:
Section 3. Federal Trade Commission
Section 4. Interstate Commerce Commission, Federal Com-
munications Commission, Civil Aeronautics
Board, Board of Governors of the Federal
Reserve System
Section 5. Postmaster General
Section 6. Secretary of Agriculture
Section 7. Contract Market Commission, Secretary of Agri-
culture
Section 8. Secretary of the Treasury
Section 9. Securities and Exchange Commission
Section 10. Securities and Exchange Commission
Section 11. Foreign Trade Zone Board
-------
1068 LEGAL COMPILATION—PESTICIDES
Section 12. Federal Communications Commission
Section 13. National Labor Relations Board
Section 14. Secretary of the Treasury
Section 15. Securities and Exchange Commission
Section 16. Federal Power Commission
Section 17. Federal Maritime Board; Secretary of Commerce
Section 18. Civil Aeronautics Board
Section 19. Federal Power Commission
Section 20. Secretary of Health, Education, and Welfare,
Secretary of Agriculture
Section 21. Secretary of Health, Education, and Welfare
Section 22. Secretary of Labor
Section 23. Railroad Retirement Board
Section 24. Secretary of Agriculture
Section 25. Securities and Exchange Commission
Section 26. Securities and Exchange Commission
Section 27. Public Health Service
Section 28. Secretary of Agriculture
Section 29. Subversive Activities Control Board
Section 30. Detention Review Board
Section 31. Federal Communications Commission, Secretary of
Agriculture, Federal Maritime Board, Maritime
Administration, Atomic Energy Commission
Section 32. Department of Health, Education, and Welfare
Section 33. Attorney General (Executive Order 10644)
Section 34. Board of Governors of the Federal Reserve System
[p. 10]
5. Section 21 of the bill would amend section 701 (f) of the
Federal Food, Drug, and Cosmetic Act to provide in effect that the
filing and contents of the administrative record with the court
shall be governed by the proposed section 2112 of title 21 United
States Code. We believe that, in the interest of uniformity within
the Federal Food, Drug, and Cosmetic Act the additional changes
contained in section 20 of the bill, above referred to, should also
be incorporated in section 21. We therefore suggest that section 21
be changed to read as follows:
"SEC. 21. (a) The second and third sentences of paragraph (1)
of subsection (f) of section 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371 (f)), are amended to read as follows:
'A copy of the petition shall be forthwith transmitted by the clerk
of the court to the Secretary or any officer designated by him for
that purpose, and thereupon the Secretary shall file in the court
the record of the proceedings on which he based his order, as
-------
STATUTES AND LEGISLATIVE HISTORY 1069
provided in section 2112 of title 28, United States Code.'
"(b) The first sentence of paragraph (3) of subsection (f) of
section 701 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 371 (f)) is amended to read as follows: 'Upon the filing of
the petition referred to in paragraph (1) of this subsection, the
court shall have jurisdiction to affirm the order, or to set it aside in
whole or in part, temporarily or permanently'."
[p. 21]
SEC. 21. (a) The second and third sentences of paragraph (1)
of subsection (f) of section 701 of the Federal Food, Drug, and
Cosmetic Act (52 Stat. 1055), as amended: A copy of the petition
shall be forthwith transmitted by the clerk of the court to the
Secretary or other officer designated by him for that purpose. [The
summons and petition may be served at any place in the United
States.] "The Secretary [promptly upon service of the summons
and petition] thereupon shall [certify and] file in the court the
[p. 43]
[transcript] record of proceedings [and the record] on which the
Secretary based his order, as provided in section 2112 of title 28,
United States Code." (21 U.S.C., sec. 371, Secretary of Health,
Education, and Welfare).
(b) The first sentence of paragraph 3 of subsection (f) of sec-
tion 701 of the Federal Food, Drug, and Cosmetic Act (52 Stat.
1055), as amended: "Upon the filing of the petition referred to in
paragraph (1) of this subsection, the court shall have jurisdiction
to affirm the order, or to set it aside in whole or in part, temporar-
ily or permanently." j- 44-,
1.12g (2) SENATE COMMITTEE ON THE JUDICIARY
S. REP. No. 2129, 85th Cong., 2d Sess. (1958)
AUTHORIZING ABBREVIATED RECORDS IN REVIEWING
ADMINISTRATIVE AGENCY PROCEEDINGS
AUGUST 4,1958.—Ordered to be printed
Mr. EASTLAND, from the Committee on the Judiciary, submitted the
following
REPORT
[To accompany H.R. 6788]
The Committee on the Judiciary, to which was referred the bill
(H.R. 6788) to authorize the abbreviation of the record on the
review or enforcement of orders of administrative agencies by the
-------
1070 LEGAL COMPILATION—PESTICIDES
courts of appeals and the review or enforcement of such orders on
the original papers and to make uniform the law relating to the
record on review or enforcement of such orders, and for other
purposes, having considered the same, reports favorably thereon,
without amendment, and recommends that the bill do pass.
PURPOSE
The purpose of the proposed legislation is to save time and
expense by permitting the several courts of appeals to adopt rules
authorizing the abbreviation of the transcript and other parts of
the record made before Federal administrative agencies when the
orders of those agencies are to be reviewed by the courts of appeals.
If review proceedings have been instituted in two or more courts
with respect to the same order, the bill would require the Federal
administrative agency involved to file the record in that court in
which the proceeding was first instituted, but in the interest of
justice and for the convenience of the parties, such court may
thereafter transfer the proceedings to another court of appeals.
[p.l]
STATEMENT
1. ORIGIN AND PRIOR CONSIDERATION
This proposal emanates from the Judicial Conference of the
United States. It was submitted to the Congress after substantial
consideration by the Committee on Revision of the Laws of the
Judicial Conference and the Judicial Conference itself. After
submission, it was the subject of a hearing before a subcommittee
of the House Committee on the Judiciary on May 17, 1956, and
subjected to agency comments. It was thereafter revised and
reintroduced and again subjected to review by the administrative
agencies. Following this, the Judiciary Committee after adopting
several amendments, reported the bill to the House of Representa-
tives, which later approved it.
The bill has been approved in principle by the American Bar
Association, and it incorporates a recommendation of the Presi-
dent's Conference on Administrative Procedure. It likewise carries
the approval of the Judicial Conference of the United States.
2. DISCUSSION AND SUMMARY
Most of the present statutes which provide for judicial review or
enforcement by the courts of appeals of the orders of administra-
tive agencies require that a transcript of the entire record of the
proceedings before the agency be prepared by the agency and
physically filed with the court. Such a requirement frequently
-------
STATUTES AND LEGISLATIVE HISTORY 1071
operates to delay court proceedings and to impose upon the agency
large and unnecessary expenditures of money and effort. In many
types of cases the agency record involves persons other than the
petitioner for review. The record may, therefore, be unnecessarily
voluminous and much of it irrelevant to the review.
The object of the instant legislation is to eliminate the filing of
the entire record except in those instances where it is required for
an adequate determination or where the abbreviation of the record
would prove more costly than the transmission of the entire record.
This objective could have been accomplished by a general statute
repealing all inconsistent provisions of the various acts providing
for judicial review of agency action. Such a course, however, would
have left a residuum of doubt as to whether specific provisions
would have been repealed by implication. This legislation avoids
that difficulty by direct amendment of the many existing statutes
providing for judicial review of administrative determinations
and orders.
Many of the statutes providing for the enforcement or review of
agency orders provide that the courts of appeals acquire jurisdic-
tion upon the filing of the petition for review. Many others provide
however, that jurisdiction is not acquired by the courts until the
filing of the transcript of the record. This latter provision has
sometimes proved both illogical and unwise—illogical, since it
places authority within the Federal agency to delay the acquisition
[p. 2]
of full jurisdiction by a Federal appellate court; and unwise, since
it raises a serious question concerning the extent of the court's
authority to make orders relating to the filing of the record or
other preliminary orders between the time of filing the petition
for review and the time when the record is actually filed. Accord-
ingly, this legislation proposes to amend various statutes to pro-
vide that in all cases the reviewing court shall acquire jurisdiction
upon the filing of a petition on review. However, the bill further
provides that although jurisdiction shall be immediately acquired
by the court upon the filing of a petition for review, the existing
jurisdiction of agencies, pending filing of the record, is preserved
and until such filing the (jurisdiction shall be concurrent and shall
become exclusive in the appellate court only upon the filing of the
record. This provision was added in order to make clear that up
to the filing of the record or transcript, an agency may retain
jurisdiction in order to permit that agency to entertain motions
for additional processes before the administrative agency, such as
the modification or setting aside of an order.
-------
1072 LEGAL COMPILATION—PESTICIDES
This legislation accomplishes its objective of permitting the
filing of abbreviated records by adding a new section, section 2112,
to title 28, of the United States Code, and amending the several
statutes relating to appeals from administrative agencies to bring
them into conformity with the provisions of this new section of
title 28. The bill seeks to accomplish its purposes in the following
ways:
(1) By giving the courts of appeals, with the approval of
the Judicial Conference, authority to adopt rules on the
subject, which are to be so far as practicable uniform in all
courts.
(2) By providing for the abbreviation of the record to
include only those materials which are relevant to the issues
involved as determined by the rules or special orders of the
court or by stipulation of the parties.
(3) By providing in appropriate cases which can be dis-
posed of on the pleadings, such as consent decrees, that no
record at all need be filed.
(4) By permitting the entire record to be filed in those
cases where the parties find it will be less expensive and time
consuming to do so than to select and copy portions of it for
filing. The selection of the relevant portions of the record to
be printed in the petitioner's appendix can sometimes better
be done at the brief-writing stage.
(5) By providing that the courts may permit an agency to
file in court merely a list of the materials in the record while
retaining in its custody the materials themselves until any
such materials are actually needed and sent for by the court.
(6) By authorizing the agency, if it finds it better to do so,
to transmit original papers, rather than copies, as the record
on review. These are, of course, to be returned to the agency
upon the termination of the proceeding, or earlier if needed.
The bill would further accomplish its objectives by amending the
various statutes now providing for the review and enforcement of
agency orders so as to bring about uniformity in their provisions
by—
(7) Providing that the record shall be filed in each case as
provided in the new section 2112 of title 28; r 31
(8) Providing that the jurisdiction of the court of appeals
shall attach in all cases upon the filing of the petition for
review or enforcement, while preserving the concurrent juris-
diction of the agency, in appropriate cases, until the record is
filed; and
-------
STATUTES AND LEGISLATIVE HISTORY 1073
(9) Providing that in all cases it shall be the duty of the
clerk of the court to transmit to the agency a copy of the peti-
tion for review which has been filed with the court.
In addition, the bill meets the problem which is presented when
petitions by different aggrieved parties to review the same
agency order are filed in different circuits. It does so by providing
that the court of appeals in which the first petition is filed shall
have exclusive jurisdiction of all the petitions but with power to
transfer them all to another court of appeals if the convenience of
the parties and the interests of justice so require. At present the
agency, by selecting the court in which it files the record, deter-
mines which court shall have jurisdiction.
CONCLUSION
With the advent of an increasing number of bureaus and agen-
cies within the Federal Government, the Congress has seen fit to
authorize judicial review of the orders of such agencies and bu-
reaus in order to afford maximum protection to the interests of
the Government and the individual or corporate litigant. In many
cases this review function has been placed upon the Federal courts
of appeals, thereby increasing the workload of that part of the
Federal court system. Part of that workload involves the perusal of
records filed in connection with such appeals. These records are
frequently voluminous and are not edited, so as to encompass only
information relevant to the points at issue. The reduction of such
a record to its pertinent parts, as proposed here, should in most
cases serve as an aid to the expedition of appeals from orders of
administrative agencies. Thus, adoption of this measure is expect-
ed to facilitate the work of the Federal appellate courts. Moreover,
this legislation is likewise expected to occasion a saving in time
and expense to the Federal Government in its role as litigant. The
cost of preparing the transcript in nearly all cases rests with the
agency and is, therefore, a charge upon the Federal Treasury.
Consequently, any reduction in the size of the record which
must be filed could result in reducing the cost of litigation to
the Government.
In addition to these considerations, the authority conferred by
the bill contains sufficient flexibility to permit an appellate court
to adapt its procedures to the exigencies of cases presented to it.
Thus, if a litigant, either an indivdiual or an agency, determined
that the cause of justice, or considerations of time or expense,
require the submission of a full record, that may be done. The
purpose of the proposal is expedition, but not expedition at the
expense of justice.
-------
1074 LEGAL COMPILATION—PESTICIDES
The bill was the subject of thorough consideration in the Judi-
cial Conference prior to its submission to the Congress, and since
its submission has been reviewed in detail by the administrative
agencies. It is also appropriate to note that the agency primarily
concerned with litigation involving the Federal Government, the
Department of Justice, considers the proposal "a laudible effort
[p. 4]
to eliminate unnecessary expenditures in time and money in the
review of agency orders by the courts of appeals." In short, the
Department of Justice recommends enactment of the measure.
The acceptance and approval of this bill by the bench and the bar
indicates that it may reasonably be calculated to accomplish the
worthwhile objective which it is designed to accomplish. Conse-
quently, the committee recommends favorable consideration of
the legislation.
Attached to this report is the letter of transmittal of the Admin-
istrative Office of United States Court, dated April 5,1957, and the
report of the Department of Justice under date of June 10, 1957, to
which reference was made earlier. The other agency reports on the
bill are incorporated in House Report No. 842 of the 85th Congress,
1st session. In the interests of brevity they may be considered as
having been incorporated by reference in this report.
[p-5]
SEC. 21. (a) The second the third sentences of paragraph (1)
of subsection (f) of section 701 of the Federal Food, Drug, and
Cosmetic Act (52 Stat. 1055), as amended: A copy of the petition
shall be forthwith transmitted by the clerk of the court to the
Secretary or other officer designated by him for that purpose. [The
summons and petition may be served at any place in the United
States.] The Secretary [promptly upon service of the summons and
petition] thereupon shall [certify and] file in the court the [tran-
script] record of the proceedings [and the record] on which the
Secretary based his order, as provided in section 2112 of title 28,
United States Code."
(b) The first sentence of paragraph 3 of subsection (f) of
section 701 of the Federal Food, Drug, and Cosmetic Act (52 Stat.
1055), as amended: "Upon the filing of the petition referred to in
paragraph (1) of this subsection, the [The] court shall have juris-
diction to affirm the order, or to set it aside in whole or in part,
temporarily or permanently." (21 U.S.C., sec. 371, Secretary of
Health, Education, and Welfare.)
[P. 17]
-------
STATUTES AND LEGISLATIVE HISTORY
1075
1.12g (3) CONGRESSIONAL RECORD
1.12g (3) (a) VOL. 103 (1957), Aug. 5: Amended and passed
House, p. 13620
[No Relevant Discussion on Pertinent Section]
1.12g (3) (b) VOL. 104 (1958), Aug. 14: Passed Senate, p. 17537
ENFORCEMENT OP ORDERS OF
ADMINISTRATIVE AGENCIES
The bill (H. R. 6788) to authorize
the abbreviation of the record on the
review or enforcement of orders of ad-
ministrative agencies, was announced
as next in order.
Mr. HRUSKA. Mr. President, may
we have an explanation of the bill?
Mr. EASTLAND. Mr. President, this
bill authorizes the several courts of ap-
peals of the United States to adopt
rules authorizing the abbreviation of
the transcript and other parts of the
record made before Federal adminis-
trative agencies when the orders of
those agencies are to be reviewed by
the courts of appeals. Under several
existing statutes permitting appeals to
the court of appeals from the findings
and orders of administrative agencies,
it is necessary for the administrative
agency to prepare and file the entire
record of the proceedings before the
administrative agency. This oftentimes
results in a voluminous record, much
of it not pertinent to the matters under
review. Many times, likewise, the rec-
ord involves other applicants not a
party to the appeal.
Under the authority conferred by
this bill, the courts of appeals could,
by special order or by stipulation of
the parties, provide for the filing of
only those materials which are rele-
vant to the issues before the court. In
such matters the courts of appeals
must, of necessity, have some latitude,
and this legislation affords them that
latitude.
The bill also provides that when pe-
titions are filed in different circuits to
review the same agency order, the ju-
risdiction of all the petitions shall rest
with the court of appeals in which the
first petition is filed but that court will
have authority to transfer such cases
to another court of appeals if it ap-
pears that the convenience of the par-
ties and the interests of justice would
be served. Under existing law the
agency, by selecting the court in which
it files the record, determines which
court shall have jurisdiction.
Information submitted to the com-
mittee indicated that the adoption of
this legislation would result in the sav-
ing of time on the part of the court of
appeals. Since it is now incumbent up-
on the Federal agencies to prepare the
record for filing in the courts of ap-
peals, it is also likely that this legisla-
tion would result in a saving of time
and expense on the part of the Federal
administrative agencies.
For these reasons, the committee has
recommended that the legislation be
favorably considered.
The PRESIDING OFFICER. Is
there objection to the present consider-
ation of the bill?
There being no objection, the bill
was considered, ordered to a third read-
ing, read the third time, and passed.
[p.17537]
-------
1076 LEGAL COMPILATION—PESTICIDES
1.12H 1960 AMENDMENTS TO FEDERAL FOOD, DRUG, AND
COSMETIC ACT
July 12,1960, P.L. 86-618, Title I, §103 (a) (4), 74 Stat. 398
REGULATIONS TO ASSURE SAFETY OF COLOR ADDITIVES FOR FOODS,
DRUGS, AND COSMETICS
SEC. 103. (a) Such Act is further amended by—
(1) repealing subsection (b) of section 406 and striking out
the subsection designation "(a)" after "SEC. 406." in such
section;
(2) repealing section 504;
(3) repealing section 604; and
(4) amending section 701 (e) by (A) striking out "406 (a)
°r [p. 398]
(b)" and inserting in lieu thereof "406"; (B) striking out "504,
or 604,"; and (C) inserting the word "or" after "501 (b),".
[p. 399]
1.12h (1) SENATE COMMITTEE ON LABOR AND PUBLIC
WELFARE
S. REP. No. 795, 86th Cong., 1st Sess. (1959)
COLOR ADDITIVE AMENDMENTS OF 1959
AUGUST 21,1959.—Ordered to 'be printed
Mr. HiLL, from the Committee on Labor and Public Welfare,
submitted the following
REPORT
[To accompany S. 2197]
The Committee on Labor and Public Welfare, to whom was
referred the bill (S. 2197) to protect the public health by amending
the Federal Food, Drug, and Cosmetic Act so as to authorize the
use of suitable color additives in or on foods, drugs, and cosmetics,
in accordance with regulations prescribing the conditions (includ-
ing maximum tolerances) under which such additives may be
safely used, having considered the same, report favorably thereon
with amendments and recommend that the bill, as amended, do pass.
EXPLANATION
S. 2197 is designed to better protect the public health with
respect to procedures necessary to assure the safety of color addi-
-------
STATUTES AND LEGISLATIVE HISTORY 1077
tives in foods, drugs, and cosmetics and to authorize the use of
such color additives as have been predetermined to be perfectly
safe in the amounts in which they are to be used. The bill is
designed to meet a pressing need for replacing the inconsistent,
and in part outmoded, provisions which now govern the use of
different kinds of color for articles covered by the Federal Food,
Drug, and Cosmetic Act with a scientifically sound and uniform
system for the listing of color additives of any kind which may be
safely used in foods, drugs, or cosmetics, subject, when necessary,
to appropriate tolerance limitations and other conditions of use
and to official certification of batches of color so as to assure the
safety of such use to the consumer.
Under existing law coal-tar colors may not be used in foods,
drugs, or cosmetics unless they have been certified by the Food and
Drug Administration as harmless and suitable for use. A recent
Supreme Court decision has defined the "harmless" principle as
meaning harmless regardless of the quantity of the coal-tar color
which is being used. Thus, a color must be decertified if any
[p.l]
quantity or concentration of the color is harmful, even though in
lesser concentrations it may be perfectly safe. Because of this
principle, as defined by the Supreme Court, it has been necessary
for the Food and Drug Administration to withdraw certification
of seven food colors. Seventeen additional colors have been pro-
posed for delisting. The effect of the application of the "harmless"
principle in terms of existing law is to cause many of the coal-tar
colors widely used in industry to be no longer available, and the
number of colors withdrawn will eventually seriously handicap
manufacturers of foods, drugs, and cosmetics in the production of
products in the manner that is customary and usual.
Many food industries find themselves seriously affected by the
delisting of colors. If additional proposed delistings are accom-
plished, similar effect is faced by drug and cosmetic industries. The
very existence of many products depends upon the use of suit-
able color.
This legislation is necessary, because it will give the Secretary of
Health, Education, and Welfare a flexibility, which he does not
have under the present law, to certify coal-tar colors within toler-
ance limits which he determines are safe.
Two amendments to the bill as originally introduced were adopt-
ed by the committee. Both amendments were developed coopera-
tively by the committee staff, representatives of the industries con-
cerned, and representatives of the Food and Drug Administration.
-------
1078 LEGAL COMPILATION—PESTICIDES
Both have been declared acceptable by the Administration and by
industry. Their objectives are, first, to permit those additives
found "safe" by the Secretary under the procedures set forth in
the Food Additives Amendments Act of 1958 to be considered
"safe" when used as color additives, and secondly, to relieve the
Administration from the obligation of requiring the use of certain
analytical methods, when, in its opinion, they are not needed.
The bill as amended has the endorsement of the Administration
and of the following business groups which have concerned them-
selves with the legislation: The Certified Color Industry Commit-
tee, the Toilet Goods Association, the National Association of
Margarine Manufacturers, the International Association of Ice
Cream Manufacturers, the Grocery Manufacturers of America,
and the National Confectioners Association.
S. 2197 was introduced at the request of the Department of
Health, Education, and Welfare with the approval of the Bureau
of the Budget.
DEPARTMENTAL COMMENT
Set forth below are, first, the letter of transmittal from Arthur S.
Flemming, Secretary, Department of Health, Education and Wel-
fare, requesting the introduction of the legislation and setting
forth the principal reasons which give rise to the need for immedi-
ate action in this field, and second, letters dated August 7 and
August 12, 1959, from Elliot L. Richardson, Assistant Secretary,
Department of Health, Education, and Welfare, expressing approv-
al of the committee amendments.
* [p. 2]
[SECTION-BY-SECTION ANALYSIS]
Section 103
Subsection (a) repeals those sections (sees. 406 (b), 504, and 604)
of the basic act directing the Secretary to provide for listing, and
certification of batches, of coal-tar colors which are "harmless and
suitable" for use in food, drugs, and cosmetics, respectively; it also
repeals the references to these sections in section 701 (e) of the act.
The saving provisions of 1 U.S.C. 109, will, of course, apply to
these repeals.
Subsection (b) amends section 706 of the act to make more
flexible and, incidentally, bring together within a single section of
the act, the Secretary's rulemaking authority with respect to the
use of color additives in or on food, drugs, or cosmetics. (Under
present law, sec. 706 contains only a provision which conditions
the admitting to listing and certification of coal-tar colors upon
-------
STATUTES AND LEGISLATIVE HISTORY 1079
the payment of fees. Cf. subsec. (e) of sec. 706 as amended by the
bill.) The major provisions of the proposed section 706 are:
[p. 15]
*******
[Section 706]
Procedure for Issuance, Amendment, or Repeal of Regulations
(d) The provisions of section 701 (e), (f), and (g) of this Act
shall apply to and in all respects govern proceedings for the issu-
ance, amendment, or repeal of regulations under subsections (b),
(c), or (e) of this section (including judicial review of the Secre-
tary's action in such proceedings) and the admissibility of tran-
scripts of the record of such proceedings in other proceedings,
except that—
(1) the Secretary's order after public hearing (acting upon
objections filed to an order made prior to hearing) shall be
subject to the requirements of section 409(f) (2); and
(2) the scope of judicial review of such order shall be in
accordance with the third sentence of paragraph (2), and
with the provisions of paragraph (3), of section 409(g).
Fees
(e) The admitting to listing and certification of color additives,
in accordance with regulations prescribed under this Act, shall be
performed only upon payment of such fees, which shall be specified
in such regulations, as may be necessary to provide, maintain, and
equip an adequate service for such purposes.
Exemptions
(f) The Secretary shall by regulation (issued without regard to
subsection (d) provide for exempting from the requirements of
this section any color additive or any specific type of use thereof,
and any article of food, drug, or cosmetic bearing or containing
such additive, intended solely for investigational use by qualified
experts when in his opinion such exemption is consistent with the
public health.
[p. 28]
-------
1080 LEGAL COMPILATION—PESTICIDES
1.12h (2) HOUSE COMMITTEE ON INTERSTATE AND FOR-
EIGN COMMERCE
H.R. REP. No. 1761,86th Cong., 2d Seas. (1960)
COLOR ADDITIVE AMENDMENTS OF 1960
JUNE 7,1960.—Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
Mr. HARRIS, from the Committee on Interstate and Foreign Com-
merce, submitted the following
REPORT
[To accompany H.R. 7624]
The Committee on Interstate and Foreign Commerce, to whom
was referred the bill (H.R. 7624) to protect the public health by
amending the Federal Food, Drug, and Cosmetic Act so as to
authorize the use of suitable color additives in or on foods, drugs,
and cosmetics, in accordance with regulations prescribing the
conditions (including maximum tolerances) under which such
additives may be safely used, having considered the same, report
favorably thereon with amendments and recommend that the bill
as amended do pass.
The amendments, as they appear in the reported bill, are as
follows: r -n
[p-1]
PURPOSE OF LEGISLATION
The purpose of this bill is to protect the public health by amend-
ing the Federal Food, Drug, and Cosmetic Act so as to authorize
the use of suitable color additives in or on foods, drugs, and cos-
metics in accordance with regulations to be issued by the Secretary
of Health, Education, and Welfare, prescribing the conditions,
including maximum tolerances, under which such additives may
be safely used.
GENERAL SUMMARY
The committee bill—
(1) takes "color additives" out of the scope of the Food
Additives Amendment of 1958;
(2) repeals the present provisions of the Federal Food,
Drug, and Cosmetic Act for the listing and certification of
"harmless" coal-tar colors (sees. 406 (b), 504, and 604) ;
(3) enacts new, integrated provisions for the separate list-
ing of suitable "color additives," safe for use in food, drugs,
-------
STATUTES AND LEGISLATIVE HISTORY 1081
or cosmetics, under such conditions (including tolerance limi-
tations) as the Secretary of Health, Education, and Welfare
may find necessary to assure the safety of the uses permitted;
(4) provides for the certification (or exemption from certi-
fication) of listed color additives for such permitted uses;
(5) adapts the adulteration and other provisions of the
Federal Food, Drug, and Cosmetic Act to the substantive and
other changes involved in the above-mentioned changes; and
(6) contains transitional provisions for commercially estab-
lished colors.
HEARINGS
Extensive hearings were held by the committee on this legisla-
tion in January, February, March, and May 1960 and a large
number of witnesses were heard. The committee also heard from
a distinguished group of scientific experts, selected by the Presi-
dent of the National Academy of Sciences, which discussed the
scientific problems involved in this legislation, with special empha-
sis on the Delaney anticancer clause.
[p. 6]
Section 103
Subsection (a) repeals those sections (sees. 406 (b), 504, and
604) of the basic act directing the Secretary to provide for listing,
and certification of batches, of coal-tar colors which are "harmless
and suitable" for use in food, drugs, and cosmetics, respectively;
it also repeals the references to these sections in section 701 (e) of
the act. The saving provisions of 1 U.S.C. 109, will, of course, apply
to these repeals.
Subsection (b) amends section 706 of the act to make more
flexible and, incidentally, bring together within a single section of
the act, the Secretary's rulemaking authority with respect to the
use of color additives in or on food, drugs, or cosmetics. (Under
present law, sec. 706 contains only a provision which conditions
the admitting to listing and certification of coal-tar colors upon
the payment of fees. Cf. subsec. (e) of sec. 706 as amended by the
bill.) The major provisions of the proposed section 706 are:
[p. 24]
[CERTIFICATION OF COAL-TAR COLORS FOR COSMETICS
[SEC. 604. The Secretary shall promulgate regulations providing
for the listing of coal-tar colors which are harmless and suitable
for use in cosmetics and for the certification of batches of such
colors, with or without harmless diluents.]
-------
1082 LEGAL COMPILATION—PESTICIDES
CHAPTER VII—GENERAL ADMINISTRATIVE PROVISIONS
REGULATIONS AND HEARINGS
SEC. 701. (a) The authority to promulgate regulations for the
efficient enforcement of this Act, except as otherwise provided in
this section, is hereby vested in the Secretary.
(b) The Secretary of the Treasury and the Secretary of Health,
Education, and Welfare shall jointly prescribe regulations for the
efficient enforcement of the provisions of section 801, except as
otherwise provided therein. Such regulations shall be promulgated
in such manner and take effect at such time, after due notice, as
the Secretary of Health, Education, and Welfare shall determine.
(c) Hearings authorized or required by this Act shall be con-
ducted by the Secretary or such officer or employee as he may
designate for the purpose.
(d) The definitions and standards of identity promulgated in
accordance with the provisions of this Act shall be effective for the
purposes of the enforcement of this Act; notwithstanding such
definitions and standards as may be contained in other laws of the
United States and regulations promulgated thereunder.
[p. 55]
(e) (1) Any action for the issuance, amendment, or repeal of
any regulation under section 401, 403 (j), 404 (a), 406 [ (a) or (b) ],
501 (b), or 502 (d) or (h), [504, or 604,] of this Act shall be
begun by a proposal made (A) by the Secretary on his own initia-
tive, or (B) by petition of any interested person, showing reason-
able grounds therefor, filed with the Secretary. The Secretary shall
publish such proposal and shall afford all interested persons an
opportunity to present their views thereon, orally or in writing.
As soon as practicable thereafter, the Secretary shall by order act
upon such proposal and shall make such order public. Except as
provided in paragraph (2), the order shall become effective at such
time as may be specified therein but not prior to the day following
the last day on which objections may be filed under such paragraph.
(2) On or before the thirtieth day after the date on which an
order entered under paragraph (1) is made public, any person who
will be adversely affected by such order if placed in effect may file
objections thereto with the Secretary, specifying with particular-
ity the provisions of the order deemed objectionable, stating the
grounds therefor, and requesting a public hearing upon such
objections. Until final action upon such objections is taken by the
Secretary under paragraph (3), the filing of such objections shall
operate to stay the effectiveness of those provisions of the order to
which the objections are made. As soon as practicable after the
-------
STATUTES AND LEGISLATIVE HISTORY 1083
time for filing objections has expired the Secretary shall publish
a notice in the Federal Register specifying those parts of the
order which have been stayed by the filing of objections and, if no
objections have been filed, stating that fact.
(3) As soon as practicable after such request for a public hear-
ing, the Secretary, after due notice, shall hold such a public hear-
ing for the purpose of receiving evidence relevant and material to
the issues raised by such objections. At the hearing, any interested
person may be heard in person or by representative. As soon as
practicable after completion of the hearing, the Secretary shall by
order act upon such objections and make such order public. Such
order shall be based only on substantial evidence of record
at such hearing and shall set forth, as part of the order, detailed
findings of fact on which the order is based. The Secretary shall
specify in the order the date on which it shall take effect, except
that it shall not be made to take effect prior to the ninetieth day
after its publication unless the Secretary finds that emergency
conditions exist necessitating an earlier effective date, in which
event the Secretary shall specify in the order his findings as to
such conditions.
(f) (1) In a case of actual controversy as to the validity of any
order under subsection (e), any person who will be adversely
affected by such order if placed in effect may at any time prior to
the ninetieth day after such order is issued file a petition with the
Circuit Court of Appeals of the United States for the circuit
wherein such person resides or has his principal place of business,
for a judicial review of such order. A copy of the petition shall be
forthwith transmitted by the clerk of the court to the Secretary or
other officer designated by him for that purpose. The Secretary
thereupon shall file in the court the record of the proceedings on
which the Secretary based his order, as provided in section 2112
of title 28, United States Code. r ...
LP- oj
(2) If the petitioner applies to the court for leave to adduce
additional evidence, and shows to the satisfaction of the court that
such additional evidence is material and that there were reasonable
grounds for the failure to adduce such evidence in the proceeding
before the Secretary, the court may order such additional evidence
(and evidence in rebuttal thereof) to be taken before the Secretary,
and to be adduced upon the hearing, in such manner and upon
such terms and conditions as to the court may seem proper. The
Secretary may modify his findings as to the facts, or make new
findings, by reason of the additional evidence so taken, and he shall
file such modified or new findings, and his recommendation, if any,
-------
1084 LEGAL COMPILATION—PESTICIDES
for the modification or setting aside of his original order, with the
return of such additional evidence.
(3) Upon the filing of the petition referred to in paragraph (1)
of this subsection, the court shall have jurisdiction to affirm the
order, or to set it aside in whole or in part, temporarily or perma-
nently. If the order of the Secretary refuses to issue, amend, or
repeal a regulation and such order is not in accordance with law
the court shall by its judgment order the Secretary to take action
with respect to such regulation, in accordance with law. The find-
ings of the Secretary as to the facts, if supported by substantial
evidence, shall be conclusive [now covered by U.S.C. title 28, sec.
1254].
(4) The judgment of the court affirming or setting aside, in
whole or in part, any such order of the Secretary shall be final,
subject to review by the Supreme Court of the United States upon
certiorari or certification as provided in sections 239 and 240 of
the Judicial Code, as amended.
(5) Any action instituted under this subsection shall survive
notwithstanding any change in the person occupying the office of
Secretary or any vacancy in such office.
(6) The remedies provided for in this subsection shall be in
addition to and not in substitution for any other remedies provided
by law.
(g) A certified copy of the transcript of the record and pro-
ceedings under subsection (e) shall be furnished by the Secretary
to any interested party at his request, and payment of the costs
thereof, and shall be admissible in any criminal, libel for condem-
nation, exclusion of imports, or other proceeding arising under or
in respect to this Act, irrespective of whether proceedings with
respect to the order have previously been instituted or become final
under subsection (f).
*******
[COST OF CERTIFICATION OF COAL-TAR COLORS
[SEC. 706. The admitting to listing and certification of coal-tar
colors, in accordance with regulations prescribed under this Act,
shall be performed only upon payment of such fees, which shall be
specified in such regulations, as may be necessary to provide, main-
tain, and equip an adequate service for such purposes.]
[P. 7]
Section 103
Subsection (a) repeals those sections (sees. 406 (b), 504, and
604) of the basic act directing the Secretary to provide for listing,
and certification of batches, of coal-tar colors which are "harmless
-------
STATUTES AND LEGISLATIVE HISTORY 1085
and suitable" for use in food, drugs, and cosmetics, respectively; it
also repeals the references to these sections in section 701 (e) of
the act. The saving provisions of 1 U.S.C., 109, will, of course,
apply to these repeals.
[p. 70]
1.12H (3) CONGRESSIONAL RECORD
1.12h (3) (a) VOL. 105 (1959), Aug. 24: Amended and passed
Senate p. 16777
[No Relevant Discussion on Pertinent Section]
1.12K (3) (b) VOL. 106 (1960), June 25: Amended and passed
House, pp. 14334,14373,14376
[No Relevant Discussion on Pertinent Section]
1.12h (3) (c) VOL. 106 (1960), June 30: Senate concurs in House
amendments, p. 15133
[No Relevant Discussion on Pertinent Section]
1.18 PENALTIES—VIOLATION OF SECTION 331 OF
THIS TITLE
21 U.S.C. §333 (c) (1970)
[Referred to in 21 U.S.C. §346a (n)]
PENALTIES—VIOLATION OF SECTION 331
OF THIS TITLE
§333.
* * *****
Exceptions in certain cases of good faith, etc.
(c) No person shall be subject to the penalties of subsection
(a) of this section, (1) for having received in interstate com-
merce any article and delivered it or proffered delivery of it, if
such delivery or proffer was made in good faith, unless he refuses
to furnish on request of an officer or employee duly designated by
the Secretary the name and address of the person from whom he
purchased or received such article and copies of all documents, if
any there be, pertaining to the delivery of the article to him; or
(2) for having violated section 331 (a) or (d) of this title, if he
establishes a guaranty or undertaking signed by, and containing
the name and address of, the person residing in the United States
from whom he received in good faith the article, to the effect, in
case of an alleged violation of section 331 (a) of this title, that
such article is not adulterated or misbranded, within the meaning
of this chapter designating this chapter or to the effect, in case of
-------
1086 LEGAL COMPILATION—PESTICIDES
an alleged violation of section 331 (d) of this title, that such article
is not an article which may not, under the provisions of section 344
or 355 of this title, be introduced into interstate commerce; or (3)
for having violated section 331 (a) of this title, where the viola-
tion exists because the article is adulterated by reason of contain-
ing a color additive not from a batch certified in accordance with
regulations promulgated by the Secretary under this chapter, if
such person establishes a guaranty or undertaking signed by, and
containing the name and address of, the manufacturer of the color
additive, to the effect that such color additive was from a batch
certified in accordance with the applicable regulations promulgated
by the Secretary under this chapter; or (4) for having violated
section 331 (b), (c) or (k) of this title by failure to comply with
section 352 (f) of this title in respect to an article received in in-
terstate commerce to which neither section 353 (a) nor (b) (1) of
this title is applicable, if the delivery of proffered delivery was
made in good faith and the labeling at the time thereof contained
the same directions for use and warning statements as were con-
tained in the labeling at the time of such receipt of such article;
or (5) for having violated section 331 (i) (2) of this title if such
person acted in good faith and had no reason to believe that use
of the punch, die, plate, stone, or other thing involved would result
in a drug being a counterfeit drug, or for having violated section
331 (i) (3) of this title if the person doing the act or causing it to
be done acted in good faith and had no reason to believe that the
drug was a counterfeit drug.
June 25, 1938, c. 675, § 303, 52 Stat. 1043; 1940 Reorg. Plan No.
IV, § 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237, Oct. 26,
1951, c. 578, § 2, 65 Stat. 649; 1953 Reorg. Plan No. 1, §§ 5, 8, eff.
Apr. 11,1953,18 F.R. 2053, 67 Stat. 631; July 12,1960, Pub.L. 86-
618, Title I, § 105(b), 74 Stat. 403; and amended July 15, 1965,
Pub.L. 89-74, §§ 7, 9(d), 79 Stat. 233, 235; Oct. 24, 1968, Pub.L.
90-639, § 3, 82 Stat. 1361; Oct. 27, 1970, Pub.L. 91-513, Title II,
§ 701 (b), 84 Stat. 1281.
1.13a FEDERAL FOOD, DRUG, AND COSMETIC ACT PENAL-
TIES
June 25,1938, P.L. 75-717, §303, 52 Stat. 1043
PENALTIES
SEC. 303. (a) Any person who violates any of the provisions of
section 301 shall be guilty of a misdemeanor and shall on conviction
thereof be subject to imprisonment for not more than one year, or
a fine of not more than $1,000, or both such imprisonment and fine;
-------
STATUTES AND LEGISLATIVE HISTORY 1087
but if the violation is committed after a conviction of such person
under this section has become final such person shall be subject to
imprisonment for not more than three years, or a fine of not more
than $10,000, or both such imprisonment and fine.
(b) Notwithstanding the provisions of subsection (a) of this
section, in case of a violation of any of the provisions of section 301,
with intent to defraud or mislead, the penalty shall be imprison-
ment for not more than three years, or a fine of not more than
$10,000, or both such imprisonment and fine.
(c) No person shall be subject to the penalties of subsection (a)
of this section, (1) for having received in interstate commerce any
article and delivered it or proffered delivery of it, if such delivery
or proffer was made in good faith, unless he refuses to furnish on
request of an officer or employee duly designated by the Secretary
the name and address of the person from whom he purchased or
received such article and copies of all documents, if any there be,
pertaining to the delivery of the article to him; or (2) for having
violated section 301 (a) or (d), if he establishes a guaranty or
undertaking signed by, and containing the name and address of,
the person residing in the United States from whom he received
in good faith the article, to the effect, in case of an alleged viola-
tion of section 301 (a), that such article is not adulterated or mis-
branded, within the meaning of this Act, designating this Act, or
to the effect, in case of an alleged violation of section 301 (d), that
such article is not an article which may not, under the provisions
of section 404 or 505, be introduced into interstate commerce; or
(3) for having violated section 301 (a), where the violation exists
because the article is adulterated by reason of containing a coal-tar
color not from a batch certified in accordance with regulations pro-
mulgated by the Secretary under this Act, if such person estab-
[p.1043]
lishes a guaranty or undertaking signed by, and containing the
name and address of, the manufacturer of the coal-tar, to the effect
that such color was from a batch certified in accordance with the
applicable regulations promulgated by the Secretary under this Act.
[p. 1044]
-------
1088 LEGAL COMPILATION—PESTICIDES
1.13a (1) SENATE COMMITTEE ON COMMERCE
S. REP. No. 91, 75th Cong., 1st Sess. (1937)
FOODS, DRUGS, AND COSMETICS
FEBRUARY 15,1937.—Ordered to be printed
Mr. COPELAND, from the Committee on Commerce, submitted the
following
REPORT
[To accompany S. 5]
The Committee on Commerce, to whom was referred the bill
(S. 5) to prevent the adulteration, misbranding, and false adver-
tisement of food, drugs, devices, and cosmetics, in interstate,
foreign, and other commerce subject to the jurisdiction of the
United States, for the purposes of safeguarding the public health,
preventing deceit upon the purchasing public, and for other pur-
poses, having considered the same, report thereon with certain
amendments, and as so amended, recommend that the bill do pass.
The amendments are incorporated in the bill as reported.
This bill has been prepared with three basic principles in mind:
First, it must not weaken the existing laws; second, it must
strengthen and extend that law's protection of the consumer; and
third, it must impose on honest industrial enterprise no hardship
which is unnecessary or unjustified in the public interest.
[p.lj
Technical, innocent violations of this bill will frequently arise.
Overzealous enforcement officers could cause honest business untold
damage and annoyance. The bill, therefore, limits the enforcement
officers in the drastic power of unlimited seizure to cases of adulter-
ation and those cases of misbranding where, in the public interest,
the power should be exercised. In addition, this bill increases the
criminal penalties for adulteration and misbranding over those in
the existing law, and adds injunction, temporary and permanent,
as a means of prohibiting adulteration and misbranding. The exist-
ing law does not have such a provision.
[p. 4]
The only other change of consequence in the seizure provision is
that when seizures have been made the trial may be held in a dis-
trict of reasonable proximity to the claimant's place of business.
Nothing is claimed for this provision except that it is fair. Goods
must be seized wherever found. But, there is no reason why a
-------
STATUTES AND LEGISLATIVE HISTORY 1089
claimant for the goods, who perhaps may reside across the conti-
nent, should be compelled to cross the country to try the case.
A summary of the principal respects in which this bill increases
the scope of the old law and affords the public greater protection
follows:
*******
GENERAL ^P- *
20. Prohibits the use of poisonous containers for food, drugs,
and cosmetics.
21. Requires that food, drugs, and cosmetics be prepared and
handled under conditions of reasonable cleanliness.
22. Forbids the use of uncertified and impure coal-tar colors in
food, drugs, and cosmetics.
23. Prohibits slack-filling and the use of deceptive containers for
food and drugs.
24. Provides for factory inspection and the procurement of rec-
ords needed to prove Federal jurisdiction.
25. Provides increased penalties for violations.
26. Authorizes the Federal courts to enjoin violations.
[p. 6]
1.13a (2) SENATE COMMITTEE ON COMMERCE
S. REP. No. 152, 75th Cong., 1st Sess. (1937)
FOODS, DRUGS, AND COSMETICS
MARCH 8,1937.—Ordered to be printed
Mr. COPELAND, from the Committee on Commerce, submitted, in
lieu of Senate Report No. 91, the following
AMENDED REPORT
[To accompany S. 5]
The Committee on Commerce, to whom was referred the bill
(S. 5) to prevent the adulteration, misbranding, and false adver-
tisement of food, drugs, devices, and cosmetics, in interstate,
foreign, and other commerce subject to the jurisdiction of the
United States, for the purposes of safeguarding the public health,
preventing deceit upon the purchasing public, and for other pur-
poses, and which was heretofore reported with certain amend-
ments, submit herewith an amended report and recommend that
the bill, as amended, do pass. The amendments are incorporated in
the bill as reported. r ,,
Lp- 1J
-------
1090 LEGAL COMPILATION—PESTICIDES
Technical, innocent violations of this bill will frequently arise.
Overzealous enforcement officers could cause honest business
untold damage and annoyance. The bill, therefore, limits the en-
forcement officers in the drastic power of unlimited seizure to
cases of adulteration and those cases of misbranding where, in the
public interest, the power should be exercised. In addition, this bill
increases the criminal penalties for adulteration and misbranding
over those in the existing law, and adds injunction, temporary and
permanent, as a means of prohibiting adulteration and misbrand-
ing. The existing law does not have such a provision.
[p-4]
FOODS, DRUGS, AND COSMETICS
The only other change of consequence in the seizure provision is
that when seizures have been made the trial may be held in a
district of reasonable proximity to the claimant's place of business.
Nothing is claimed for this provision except that it is fair. Goods
must be seized wherever found. But, there is no reason why a
claimant for the goods, who perhaps may reside across the conti-
nent, should be compelled to cross the country to try the case.
A summary of the principal respects in which this bill increases
the scope of the old law and affords the public greater protection
follows:
*******
[p. 5]
GENERAL
20. Prohibits the use of poisonous containers for food, drugs,
and cosmetics.
21. Requires that food, drugs, and cosmetics be prepared and
handled under conditions of reasonable cleanliness.
22. Forbids the use of uncertified and impure coal-tar colors in
food, drugs, and cosmetics.
23. Prohibits slack-filling and the use of deceptive containers for
food and drugs.
24. Provides for factory inspection and the procurement of
records needed to prove Federal jurisdiction.
25. Provides increased penalties for violations.
26. Authorizes the Federal courts to enjoin violations.
[P. 6]
-------
STATUTES AND LEGISLATIVE HISTORY 1091
1.13a (3) HOUSE COMMITTEE ON INTERSTATE AND FOR-
EIGN COMMERCE
H.R. REP. No. 2139, 75th Cong., 3rd Sess. (1938)
FOOD, DRUG, AND COSMETIC ACT
APRIL 14,1938.—Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
Mr. LEA, from the Committee on Interstate and Foreign Commerce,
submitted the following
REPORT
[To accompany S. 5]
The Committee on Interstate and Foreign Commerce, to whom
was referred the act (S. 5) to prevent the adulteration, misbrand-
ing, and false advertising of food, drugs, devices, and cosmetics
in interstate, foreign, and other commerce subject to the jurisdic-
tion of the United States, for the purposes of safeguarding the
public health, preventing deceit upon the purchasing public, and
for other purposes, report favorably thereon with an amendment
and recommend that the act do pass.
The committee amendment strikes out all of the Senate bill and
inserts in lieu thereof a substitute which appears in the reported
bill in italic type.
The act herewith reported is the culmination of more than 5
years of study by your committee.
GENERAL PURPOSES
This act seeks to set up effective provisions against abuses of
consumer welfare growing out of inadequacies in the Food and
Drugs Act of June 30, 1906, as amended (U. S. C., title 21, sees.
1-15). That act is popularly known as the Wiley pure-food law,
because that great pioneer in pure food and drug legislation, Dr.
Harvey W. Wiley, led the fight for its enactment.
While the old law has been of incalculable benefit to American
consumers, it contains serious loopholes and is not sufficiently
broad in its scope to meet the requirements of consumer protection
under modern conditions.
[p.l]
Section 303 increases substantially the criminal penalties of the
present law which some manufacturers have regarded as substan-
tially a license fee for the conduct of an illegitimate business. Ap-
-------
1092 LEGAL COMPILATION—PESTICIDES
propriate exemptions are provided for dealers who innocently
receive and distribute illegal goods.
[p. 4]
Further opportunity for review of a regulation placed in effect
by the Secretary will occur in criminal, injunction, libel for con-
demnation, exclusion of imports, or other proceedings instituted by
the Government under the bill, in which the defendant is charged
with violating the regulation (see sees. 302, 303, 304, and 801). If,
through prior review proceedings, there has been a final determina-
tion of the validity of the regulation or order in question by the
Supreme Court of the United States, or the circuit court of appeals
for the particular circuit, then the question of validity would likely
have become stare decisis. If, however, this is not the case, the
validity of the regulation or order could be inquired into and
determined in such criminal, injunction, libel for condemnation,
exclusion of imports, or other proceeding.
[p. HI
1.13a (4) COMMITTEE OF CONFERENCE
H.R. REP. No. 2716, 75th Cong., 3rd Sess. (1938)
FOOD, DRUG, AND COSMETIC ACT
JUNE 11,1938.—Ordered to be printed
Mr. LEA, from the committee of conference, submitted the following
CONFERENCE REPORT
[To accompany S. 5]
The committee of conference on the disagreeing votes of the two
Houses on the amendment of the House to the bill (S. 5) to prevent
the adulteration, misbranding, and false advertisement of food,
drugs, devices, and cosmetics in interstate, foreign, and other com-
merce subject to the jurisdiction of the United States, for the pur-
poses of safeguarding the public health, preventing deceit upon
the purchasing public, and for other purposes, having met, after
full and free conference, have agreed to recommend and do recom-
mend to their respective Houses as follows:
That the Senate recede from its disagreement to the amendment
of the House and agree to the same with an amendment as follows:
In lieu of the matter proposed to be inserted by the House amend-
ment insert the following:
[P.I]
-------
STATUTES AND LEGISLATIVE HISTORY 1093
Penalties
Sec. 303. (a) Any person who violates any of the provisions of
section 301 shall be guilty of a misdemeanor and shall on convic-
tion thereof be subject to imprisonment for not more than one year,
or a fine of not more than $1,000, or both such imprisonment and
fine; but if the violation is committed after a conviction of such
person under this section has become final such person shall be
subject to imprisonment for not more than three years, or a fine of
not more than $10,000, or both such imprisonment and fine.
(b) Notwithstanding the provisions of subsection (a) of this
section, in case of a violation of any of the provisions of section
301, with intent to defraud or mislead, the penalty shall be im-
prisonment for not more than three years, or a fine of not more
than $10,000, or both such imprisonment and fine.
(c) No person shall be subject to the penalties of subsection (a) of
this section, (1) for having received in interstate commerce any
article and delivered it or proffered delivery of it, if such delivery
or proffer was made in good faith, unless he refuses to furnish on
request of an officer or employee duly designated by the Secretary
the name and address of the person from whom he purchased or
received such article and copies of all documents, if any there be,
pertaming to the delivery of the article to him; or (2) for having
violated section 301 (a) or (d), if he establishes a guaranty or
undertaking signed by, and containing the name and address of
the person residing in the United States from whom he received in
good faith the article, to the effect, in case of an alleged violation of
section 301 (a), that such article is not adulterated or misbranded,
[p. 4]
within the meaning of this Act, designating this Act, or to the
effect, in case of an alleged violation of section 301 (d), that such
article is not an article which may not, under the provisions of
section 404 or 505, be introduced into interstate commerce; or
(3) for having violated section 301 (a), where the violation exists
because the article is adulterated by reason of containing a coal-tar
color not from a batch certified in accordance with regulations
promulgated by the Secretary under this Act, if such person estab-
lishes a guaranty or undertaking signed by, and containing the
name and address of, the manufacturer of the coal-tar color, to the
effect that such color was from a batch certified in accordance with
the applicable regulations promulgated by the Secretary under
this Act.
[p. 5]
-------
1094 LEGAL COMPILATION — PESTICIDES
1.13a(5) CONGRESSIONAL RECORD
1.13s. (5) (a) VOL. 81 (1937), March 9 : Amended and passed Sen-
ate, p. 2005
The next amendment of the committee was, in section 5, para-
graph (a) , on page 11, line 24, after the word "subdivisions", to
strike out "(1), (2), (3), (4), (6), (7), or (8)" and to insert in
lieu thereof "(a), (b), (c), (d), (f), (g), or (h) ", so as to make
the subdivision read :
CRIMINAL
SEC 5. (a) Any person who violates any of the provisions of subdivisions
(a), (b), (c), (d), (f), (g), or (h) of section 3 shall be guilty of a misde-
meanor and shall on conviction thereof be subject to imprisonment for not
more than 1 year or a fine of not more than $1,000, or both such imprison-
ment and fine; and for a second or subsequent offense imprisonment for not
more than 2 years, or a fine of not more than $5,000, or both such imprison-
ment and fine.
The amendment was agreed to. r
l.lSa (5) (b) VOL. 83 (1938), June 1: Amended and passed
House, p. 7903
[No Relevant Discussion on Pertinent Section]
1.13a (5) (c) VOL. 83 (1938), June 10: Senate agrees to confer-
ence report, pp. 8732
[No Relevant Discussion on Pertinent Section]
1.13a (5) (d) VOL. 83 (1938), June 13: House agrees to confer-
ence report, pp. 9088-9089
[No Relevant Discussion on Pertinent Section]
1.13b 1940 REORGANIZATION PLAN IV, §12, 54 STAT. 1237
SEC. 12. Transfer of Food and Drug Administration — The Food
and Drug Administration in the Department of Agriculture and its
functions, except those functions relating to the administration of
the Insecticide Act of 1910 and the Naval Stores Act, are trans-
ferred to the Federal Security Agency and shall be administered
under the direction and supervision of the Federal Security Admin-
istrator. The Chief of the Food and Drug Administration shall
hereafter be known as the Commissioner of Food and Drugs.
[p. 1237]
1.13c 1951 AMENDMENTS TO FEDERAL FOOD, DRUG, AND
COSMETIC ACT
October 26, 1951, P.L. 82-215, §2, 65 Stat. 649
SEC. 2. Subsection (c) of section 303 of the Federal Food, Drug,
and Cosmetic Act, as amended, is amended by striking out the
-------
STATUTES AND LEGISLATIVE HISTORY 1095
period at the end of clause (3) and inserting in lieu thereof a
semicolon and the following: "or (4) for having violated section
301 (b), (c) or (k) by failure to comply with section 502 (f) in
respect to an article received in interstate commerce to which
neither section 503 (a) nor section 503 (b) (1) is applicable, if
the delivery or proffered delivery was made in good faith and the
labeling at the time thereof contained the same directions for use
and warning statements as were contained in the labeling at the
time of such receipt of such article."
[p. 649]
1.13c (1) HOUSE COMMITTEE ON INTERSTATE AND FOR-
EIGN COMMERCE
H.R. REP. No. 700, 82nd Cong., 1st Sess. (1951)
AMENDING SECTION 503 (b) OF THE FEDERAL FOOD,
DRUG, AND COSMETIC ACT
JULY 16,1951.—Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
Mr. WILLIAMS of Mississippi, from the Committee on Interstate
and Foreign Commerce, submitted the following
REPORT
[To accompany H. R. 3298]
The Committee on Interstate and Foreign Commerce, to whom
was referred the bill (H.R. 3298) to amend section 503 (b) of the
Federal Food, Drug, and Cosmetic Act, having considered the
same, report favorably thereon with an amendment and recom-
mend that the bill as amended do pass.
The amendment is as follows:
Strike out all after the enacting clause and insert the following:
That subsection (b) of section 503 of the Federal Food, Drug, and Cosmetic
Act, as amended, is amended to read as follows:
" (b) (1) A drug intended for use by man which—
" (A) is a habit-forming drug to which section 502 (d) applies; Oi
"(B) because of its toxicity or other potentiality for harmful effect, or
the method of its use, or the collateral measures necessary to its use, has
been determined by the Administrator, on the basis of opinions generally
held among experts qualified by scientific training and experience to eval-
uate the safety and efficacy of such drug (and, where a public hearing is
required by paragraph (5), on the basis of evidence adduced at such
hearing by such experts), to be safe and efficacious for use only after
professional diagnosis by, or under the supervision of, a practitioner
licensed by law to administer such drug; or
-------
1096 LEGAL COMPILATION—PESTICIDES
"(C) is limited by an effective application under section 505 to use
under the professional supervision of a practitioner licensed by law to
administer such drug,
shall be dispensed only (i) upon a written prescription of a practitioner
licensed by law to administer such drug, or (ii) upon an oral prescription of
such practitioner which is reduced promptly to writing and filed by the phar-
macist, or (iii) by refilling any such written or oral prescription if such refil-
ling is authorized by the prescriber either in the original prescription or by
oral order which is reduced promptly to writing and filed by the pharmacist.
The act of dispensing a drug contrary to the provisions of this paragraph
shall be deemed to be an act which results in the drug being misbranded
while held for sale.
"(2) Any drug dispensed toy filling or refilling a written or oral prescrip-
tion of a practitioner licensed by law to administer such drug shall be exempt
from the requirements of section 502, except paragraphs (a), (i) (2) and
[p-1]
(3), (k),and (1) and the packaging requirements of paragraphs (g) and (h),
if the drug bears a label containing the name and address of the dispenser,
the serial number and date of the prescription or of its filling, the name of
the prescriber, and, if stated in the prescription, the name of the patient, and
the directions for use and cautionary statements, if any, contained in such
prescription. This exemption shall not apply to any drug dispensed in the
course of the conduct of a business of dispensing drugs pursuant to diagnosis
by mail or otherwise without examination of the patient or to a drug dispensed
in violation of paragraph (1) of this subsection.
"(3) The Administrator may by regulation remove drugs subject to section
502 (d) and section 505 from the requirements of paragraph (1) of this sub-
section when such requirements are not necessary for the protection of the
public health.
"(4) A drug which is subject to paragraph (1) of this subsection shall be
deemed to be misbranded if at any time prior to dispensing its label fails to
bear the statement 'Caution: Federal law prohibits dispensing without pres-
cription'. A drug to which paragraph (1) of this subsection does not apply
shall be deemed to be misbranded if at any time prior to dispensing its label
bears the caution statement quoted in the preceding sentence or any other
statement which represents or implies that the dispensing of the drug without
the prescription of a licensed practitioner is prohibited.
"(5) Any interested person may file with the Administrator a petition
proposing the making of a determination, or the modification of a determina-
tion made or proposed to be made, by the Administrator pursuant to subpara-
graph (B) of paragraph (1). The filing of a petition for the purpose of oppos-
ing a proposed determination that a drug is one to which such subparagraph
(B) applies shall stay the operation of paragraph (1) with respect to such
drug until a petition for judicial review can be filed and interim relief sought
under section 10 (d) of the Administrative Procedure Act. The petition shall
set forth in general terms the proposal contained therein, and shall state
reasonable grounds therefor. The Administrator shall give public notice of the
proposal made in the petition and shall give to all interested persons a reason-
able opportunity to present their views thereon, orally or in writing, and as
soon as practicable thereafter shall make public his action on the proposal.
At any time prior to the thirtieth day after such action is made public, any
interested person may file with the Administrator objections to such action,
-------
STATUTES AND LEGISLATIVE HISTORY 1097
specifying with particularity the changes proposed, stating reasonable
grounds therefor, and requesting a public hearing for the taking of evidence
of experts who are qualified by scientific training and experience to testify
on the question of whether the drug in question is safe and efficacious for use
only after professional diagnosis by, or under the supervision of, a practi-
tioner licensed by law to administer such drug. The Administrator shall
thereupon, after appropriate notice, hold such public hearing. As soon as
practicable after the hearing, the Administrator shall make his determina-
tion and issue an appropriate order. The Administrator shall make his order
only after a review of the whole record and in accordance with the reliable,
probative, and substantial evidence, and shall make detailed findings of the
facts on which he based his order. Such order shall be subject to judicial
review in accordance with the provisions of section 701 (f) and (g).
"(6) Nothing in this subsection shall be construed to relieve any person
from any requirement prescribed by or under authority of law with respect to
drugs now included or which may hereafter be included within the classifica-
tions stated in section 3220 of the Internal Revenue Code (26 U. S. C. 3220),
or to marijuana as defined in section 3238 (b) of the Internal Revenue Code
(26 U. S. C. 3238 (b) )."
SEC. 2. The provisions of this act shall take effect six months after the date
of its enactment.
WHAT THE BILL DOES
This bill amends the Federal Food, Drug, and Cosmetic Act to
accomplish two broad objectives:
(1) To strengthen the protection of the public health against
dangerous abuses in the sale of potent prescription drugs;
(2) To relieve retail druggists and the public from burdensome
and unnecessary restrictions on the dispensing of drugs which may
be safely used without supervision by a physician.
[p. 2]
The bill does this by placing in the Federal Food, Drug, and Cos-
metic Act express provisions which will eliminate confusion and
dissatisfaction which exist under the present rather general pro-
visions dealing with the labeling and dispensing of drugs which
may be sold only on prescription and drugs which may be sold over
the counter.
The bill, as amended, is designed to solve these labeling and dis-
pensing problems in the following ways:
1. By providing for a clear-cut method of distinguishing between
"prescription" drugs (that is, drugs which are not suitable for self-
medication because they should be used only under the supervision
of a physician, and which therefore should be dispensed only on
prescription) and "over-the-counter" drugs (that is, drugs which
are suitable for self-medication, and which therefore should be
permitted to be dispensed freely "over-the-counter"), and by
requiring that drugs be so labeled as to indicate to the retail drug-
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1098 LEGAL COMPILATION—PESTICIDES
gist and to the general public into which of these two classes they
fall.
Under the present law, and the regulations issued there-
under, the initial responsibility is upon the manufacturer to
decide whether his drug is unsuitable for self-medication and
therefore must be labeled with a caution legend (that is, a
warning that the drug in question may be dispensed only by
or on prescription of a physician) and may be sold only on
prescription, or whether his drug is suitable for self-
medication and therefore must be labeled with adequate direc-
tions for use and may be sold freely over the counter. Lack of
uniformity among manufacturers in interpreting the present
law and regulations has led to great confusion in the labeling
of drugs for prescription sale and for over-the-counter sale.
2. By expressly setting forth in the statute the restrictions appli-
cable to the dispensing of "prescription" drugs.
At present the restrictions on dispensing "prescription"
drugs are not specifically stated in the statute. As hereafter
explained, they result from conditions which have been im-
posed by the Federal Security Administrator in connection
with certain exemptions which he is authorized to grant under
the present law.
3. By authorizing the filling and refilling of telephone prescrip-
tions under appropriate safeguards.
The present law recognizes written and signed prescrip-
tions only, in complete disregard of the need for the use of the
telephone in prescribing medicines.
4. By specifying in detail the conditions under which pharma-
cists may refill prescriptions.
Under the present law no prescription may be lawfully
refilled unless refilling is specifically authorized in writing by
the prescribing physician. This makes it unlawful for the
pharmacist to refill prescriptions without written authoriza-
tion even for drugs which are suitable for self-medication. The
bill would permit the refilling of prescriptions for such drugs
without authorization from the physician. However, in the
case of dangerous drugs, habit-forming drugs, and new drugs
which are limited to use under medical supervision, it would
prohibit refilling unless the prescribing physician specifically
authorizes the refill. rp g-j
CHANGES IN EXISTING LAW
In compliance with paragraph 2a of rule XIII of the Rules of the
House of Representatives, changes in existing law made by the bill,
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STATUTES AND LEGISLATIVE HISTORY 1099
as introduced, are shown as follows (existing law proposed to be
omitted is enclosed in black brackets, new matter is printed in
italics, existing law in which no change is proposed is shown in
roman) :
SECTION 503 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
EXEMPTIONS IN CASE OF DRUGS AND DEVICES
SEC. 503. (a) The Administrator is hereby directed to promulgate regula-
tions exempting from any labeling or packing requirement of this Act drugs
and devices which are, in accordance with the practice of the trade, to be
processed, labeled, or repacked in substantial quantities at establishments
other than those where originally processed or packed, on condition that such
drugs and devices are not adulterated or misbranded under the provisions of
this Act upon removal from such processing, labeling, or repacking
establishment.
[ (b) A drug dispensed on a written prescription signed by a physician, den-
tist, or veterinarian (except a drug dispensed in the course of the conduct
of a business of dispensing drugs pursuant to diagnosis by mail), shall if—
[(1) such physician, dentist, or veterinarian is licensed by law to
administer such drug, and
[(2) such drug bears a label containing the name and place of busi-
ness of the dispenser, the serial number and date of such prescription,
and the name of such physician, dentist, or veterinarian,
be exempt from the requirements of section 502 (b) and (e), and (in case
such prescription is marked by the writer thereof as not refillable or its refil-
ling is prohibited by law) of section 502 (d).]
(b) A drug dispensed by filling or refilling a written or oral prescription
of a practitioner licensed by law to administer such drug shall be exempt
from the requirements of section 502, except paragraphs (a), (i) (2) and (3),
(k), and (I), and the packaging requirements of paragraphs (g) and (h),
if the drug bears a label containing the name and address of the dispenser,
the serial number and date of the prescription, or of its filling, the name of
the prescriber, and, if stated in the prescription, the name of the patient, and
the directions for use and cautionary statements, if any, contained in such
prescription. This exemption shall not apply to any drug dispensed in the
course of the conduct of a business of dispensing drugs pursuant to diagnosis
by mail or otherwise without examination of the patient. If the drug is
intended for use by man and—
(1) is a habit-forming drug subject to the regulations prescribed under
section 502 (d) ;
(2) has been found by the Administrator, after investigation and
opportunity for public hearing, to be unsafe or ineffective for use with-
out the professional diagnosis or supervision of a practitioner licensed
by law;
[p. 18]
(8) if an effective application under section 505 limits it to use under
the professional supervision of a practitioner licensed by law, such
exemption shall apply only if such drug is dispensed upon a written pres-
cription of a practitioner licensed by law to administer such drug or upon
an oral prescription of such practitioner which is reduced to writing
and filed by the pharmacist, or is dispensed by refilling a prescription
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1100 LEGAL COMPILATION—PESTICIDES
if such refilling is authorized by the prescriber in the original prescrip-
tion or by oral order and such order is reduced to writing and filed by
the pharmacist.
The Administrator may by regulation remove drugs subject to section 502
(d) and section 505 from the provision of this subsection when such require-
ments are not necessary for the protection of the public health.
A drug which is subject to clause (1), (2), or (S) of this subsection shall
be deemed to be misbranded if at any time prior to dispensing its label fails
to bear the statement "Caution: Federal law prohibits sale or dispensing
without prescription".
The act of dispensing a drug contrary to the provisions of this subsection
shall be deemed to be an act which results in the drug's being misbranded
while held for sale.
Any interested person may file with the Administrator a petition proposing
the addition to, or deletion from, the list of drugs promulgated by the Admin-
istrator in accordance with clause (2) hereof. Such petition shall set forth
the proposal in general terms and shall state reasonable grounds therefor.
The Administrator shall give public notice of the proposal and an opportunity
for all interested persons to present their views thereon, oratty or in writing,
and as soon as practicable thereafter shall make public his action upon such
proposal. At any time prior to the thirtieth day after such action is made
public any interested person may file objections to such action, specifying
with particularity the changes desired, stating reasonable grounds therefor
and requesting a public hearing upon such objections. The Administrator shall
thereupon, after due notice, hold such public hearing. As soon as practicable
after completion of the hearing, the Administrator shall by order make public
his action on such objections.
An order so issued by the Administrator may, within ninety days after its
issuance, be appealed by any interested person in accordance with the pro-
visions prescribed in section 701 (f) and (g) of this Act, except that an appeal
from the Administrator's order issued hereunder shall be in the nature of a
trial de novo, without presumptions in favor of either party to such appeal.
The provisions of this section of the Act shall not be applicable to drugs
now included or which may hereafter be included within the classifications
stated in section 3220 of the Internal Revenue Code (26 U.S.C. S220), or to
marijuana as defined in section S2S8 (b) of the Internal Revenue Code (26
U. S. C. S28 (b) ).
[p. 19]
APRIL 30, 1951.
HON. ROBERT GROSSER,
Chairman, Committee on Interstate and Foreign Commerce,
House of Representatives, Washington, D. C.
MY DEAR MR. CHAIRMAN: This is in response to your request for the views
of the Department of Justice concerning the hill (H. R. 3298) to amend sec-
tion 503 (b) of the Federal Food, Drug, and Cosmetic Act.
Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U. S. C. 352)
sets forth the various circumstances under which drugs and devices will be
deemed to be misbranded. Section 503 (b) (21 U. S. C. 353 (b) ) specifies cer-
tain exemptions with respect to drugs dispensed on written prescriptions.
The bill would amend section 503 (b) so as to provide that a drug dispensed
by filling or refilling a written or oral prescription shall be exempt from the
-------
STATUTES AND LEGISLATIVE HISTORY 1101
requirements of section 502, except with respect to certain packaging require-
ments and those provisions of the section which provide that a drug shall be
deemed to be misbranded if its labeling is false or misleading in any particu-
lar or if it is an imitation of another drug or if it is offered for sale under the
name of another drug, and except with respect to the provisions of the act
dealing with insulin and the various antibiotics covered by the statute. The
measure provides, however, that such exemption shall prevail only if the drug
bears a label containing the name and address of the dispenser, the serial
number and date of the prescription or of its filling, the name of the pres-
criber and, if stated in the prescription, the name of the patient, and the
directions for use and cautionary statements, if any, contained in the
prescription.
Separate provision is made if the drug is intended for use by man, and is
(1) a habit-forming drug subject to the regulations prescribed under section
502 (d) (21 U. S. C. 352 (d)), or (2) has been found by the Federal Security
Administrator to be unsafe or ineffective for use without the professional
diagnosis or supervision of a practitioner licensed by law, or (3) if an effec-
tive new drug application under section 505 (21 U. S. C. 355) limits it to use
under the professional supervision of a licensed practitioner. In such event
the exemption is to apply only if the drug is dispensed upon a written pres-
cription or upon an oral prescription which is reduced to writing and filed
by the pharmacist, or is dispensed by refilling a prescription if such refilling
is authorized by the prescriber in the original prescription or the oral order
and such order is reduced to writing and filed by the pharmacist. A drug which
falls within the three categories mentioned immediately above will be mis-
branded if at any time prior to its being dispensed its label fails to bear the
statement "Caution: Federal law prohibits sale or dispensing without
prescription."
The bill also provides that the act of dispensing the drug contrary to the
provisions of the bill shall be deemed to be an act which results in the drug's
being misbranded while held for sale. This would insert into the Federal
Food, Drug, and Cosmetic Act the theory, based on regulations, pursuant to
which the Food and Drug Administration has recommended prosecution of
druggists who sell, without prescriptions, drugs bearing the so-called pres-
[P- 22]
cription legend and which have not been removed from the immediate con-
tainers in which they were shipped in interstate commerce. Such a sale by a
druggist would be in violation of section 301 (k) (21 U. S. C. 331 (k) ).
The bill also provides a procedure whereby any interested person may file a
petition with the Federal Security Administrator proposing the addition to
or deletion from the list of drugs found to be unsafe or ineffective for use in
accordance with clause (2) of section 503 (b). Upon the filing of such a
petition, the Administrator is required to give public notice of the proposal
and a hearing thereon, and as soon as practicable thereafter shall make pub-
lic his action upon such proposal. Any interested person may file objections
to such action and request a public hearing upon such objections. The Admin-
istrator shall thereupon after due notice hold such public hearing and as
soon as practicable thereafter by order make public his action on such objec-
tions. The order of the Administrator may within 90 days after its issuance
be appealed to the court of appeals in accordance with the provisions pres-
cribed in section 701 (f) and (g) of the Act (21 U. S. C. 371 (f) and (g) ),
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1102 LEGAL COMPILATION—PESTICIDES
except that such appeal shall be in the nature of a trial de novo without pre-
sumptions in favor of either party to such appeal.
The bill also provides that its provisions shall not apply to drugs now
included or which may hereafter be included within the classification stated
in section 3220 of the Internal Revenue Code or to marijuana as defined in
section 3238 (b) thereof.
Whether the bill should be enacted involves a question of policy concerning
which this Department prefers not to make any recommendation. There are
certain features of the measure, however, concerning which the committee
may wish to give further consideration.
The bill provides for two public hearings in connection with a proposal
for the addition to or deletion from the list of drugs found to be unsafe in
accordance with the provisions of clause 2. A public hearing is provided for
on the original proposal, and again provided for in connection with objections
to the action of the Administrator upon the proposal. It would seem that one
public hearing on the original proposal would be sufficient.
The bill also provides for an appeal from the order of the Administrator.
It is assumed that the order referred to is that made after the public hearing
on the objections to the previous action of the Administrator. The review
proceeding is to be in accordance with the provisions of section 701 (f) and
(g) of the act, except that the appeal shall be in the nature of a trial de novo.
It will be noted, however, that the review proceedings in section 701 are con-
fined to questions of law. The court is given jurisdiction to affirm the order
complained of or to set it aside in whole or in part. If the order refuses to
issue, amend, or repeal a regulation and such order is not in accordance with
law, the court shall by its judgment order the Administrator to take
action with respect to the matter, in accordance with law. In a de novo pro-
ceeding the court ordinarily has the power and function to make its own find-
ings and judgment. Such a trial contemplates not only the record before the
Administrator but the testimony of additional witnesses if desired. No such
procedure is contemplated under section 701. The provision for a trial de
novo would be incompatible with the review procedure provided for and
leaves an ambiguity and doubt as to what the function of the appellate court
would be. In addition, such a proceeding would appear to make the appellate
court a revising agency and its action in the nature of an administrative
decision. A question arises as to whether such a function is within the judi-
cial power conferred upon Federal courts by the Constitution. Compare Radio
Commission v. General Electric Co. (281 U. S. 464).
It might -be desirable to consider the question of review in connection with
the action of the Administrator in designating unsafe drugs under clause
(2). It is believed that a review from such a determination in accordance with
the procedure in section 701, would fully protect the rights of any person
adversely affected since the Supreme Court has recently held that in consider-
ing the question of whether an order of this nature is supported by substan-
tial evidence, the appellate court shall review the whole record.
The Director of the Bureau of the Budget has advised that there is no
objection to the submission of this report.
Yours sincerely,
PEYTON FORD,
Deputy Attorney General.
[p. 23]
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STATUTES AND LEGISLATIVE HISTORY 1103
1.13c (2) SENATE COMMITTEE ON LABOR AND PUBLIC
WELFARE
S. REP. No. 946, 82nd Cong., 1st Sess. (1951)
AMENDING SECTIONS 303 (C) AND 503 (B) OF THE
FEDERAL FOOD, DRUG, AND COSMETIC ACT
OCTOBER 12 (legislative day, OCTOBER 1), 1951.—Ordered to be printed
Mr. HUMPHREY, from the Committee on Labor and Public Welfare,
submitted the following
R E P OR T
[To accompany H. R. 3298]
The Committee on Labor and Public Welfare, to whom was re-
ferred the bill (H.R. 3298) to amend section 503 (b) of the Fed-
eral Food, Drug, and Cosmetic Act, as amended, having considered
the same, report favorably thereon with amendments and recom-
mend that the bill, as amended, do pass.
The amendments are as follows:
(1) On page 3, line 5, strike out the words "or otherwise with-
out examination of the patient" and insert in lieu thereof a comma.
(2) On page 3, lines 19-22, strike out the words "or any other
statement which represents or implies that the dispensing of the
drug without the prescription of a licensed practitioner is pro-
hibited."
(3) On page 4, between lines 5 and 6, insert a new section 2, to
read as follows:
SEC. 2. Subsection (c) of section 303 of the Federal Food, Drug, and Cos-
metic Act, as amended, is amended by inserting before the period a semicolon
and the following: "or (4) for having violated section 301 (b), (c), or (k)
by failure to comply with section 502 (f) in respect to an article received in
interstate commerce to which neither section 503 (a) nor section 503 (b) (1)
is applicable, if the delivery or proffered delivery was made in good faith and
the labeling at the time thereof contained the same directions for use and
warning statements as were contained in the labeling at the time of such
receipt of such article."
(4) On page 4, line 6, strike out the figure "2" and insert in lieu
thereof the figure "3."
INTRODUCTION
This bill amends the Federal Food, Drug, and Cosmetic Act to
deal more directly and realistically with the labeling and dispensing
of drugs that may be sold only upon the prescription of licensed
practitioners. It has a twofold objective: (1) to protect the public
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1104 LEGAL COMPILATION—PESTICIDES
from abuses in the sale of potent prescription drugs; and (2) to
[P.I]
relieve retail pharmacists and the public from burdensome and
unnecessary restrictions on the dispensing of drugs that are safe
for use without the supervision of a physician. The committee
believes that the bill, as amended, will serve to eliminate much
confusion and dissatisfaction caused by ambiguities in the present
provisions of the act, and will benefit drug manufacturers, retail
druggists, medical practitioners, and the public.
In its consideration of this bill, the Committee has had the
benefit of careful study of its provisions by its standing Subcom-
mittee on Health. The subcommittee carefully and thoroughly
explored the need for such legislation at this time, and examined
the manner in which the provisions of the bill are adapted to deal
with the serious problems which have been shown to exist in con-
nection with the labeling and dispensing of both "prescription"
and "over-the-counter" drugs. Hearings on the bill were held
before the subcommittee from September 11 through September
13, 1951. Favorable action on the bill was urged at the hearing by
the Federal Security Administrator and by the Food and Drug
Administration, the agency of the Government that administers
and enforces the Federal Food, Drug, and Cosmetic Act. In addi-
tion, virtually all segments of the drug industry, including the
principal associations of drug manufacturers, the retail druggists,
and the licensed pharmacists were represented at the hearing and
submitted testimony which clearly shows that this bill is necessary
legislation and will do much to make the Act a fairer and more
effective instrument for protecting the public against abuses in the
labeling and dispensing of drugs. A representative of the Ameri-
can Medical Association testified at the hearing in support of
the bill.
The hearing held before the subcommittee developed the fact
that while there was virtually unanimity of opinion of those who
testified as to the need for basic changes in the law governing the
labeling and dispensing of "prescription" drugs, there were two
principal issues in controversy.
1. The first area of controversy was over a proposal to autho-
rize the Federal Security Administrator to list by name or class
the "dangerous" drugs that may be sold only on prescription. The
subcommittee had before it for consideration at the time of the
hearing, not only this bill, which has been passed by the House of
Representatives, but also the companion Senate bill (S. 1186), and
amendments in the nature of a substitute therefor, introduced by
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STATUTES AND LEGISLATIVE HISTORY 1105
Senator Humphrey. The principal difference between the bill as
passed by the House of Representatives and Senator Humphrey's
amendments in the nature of a substitute, had to do with the re-
quirement under which, as part of the definition of so-called dan-
gerous drugs, an administrative determination would have been
necessary thus to classify a drug. The amendments in the nature
of a substitute for S. 1186 also set forth detailed procedures,
including administrative hearings to be followed in connection with
the making of administrative determinations referred to, together
with provisions for judicial review of such determinations.
Prior to the hearing, the provisions for administrative listing of
so-called dangerous drugs were vigorously supported by the Na-
tional Association of Retail Druggists, and equally vigorously
opposed by the several associations of drug manufacturers, includ-
ing the American Pharmaceutical Manufacturers' Association, the
[P. 2]
American Drug Manufacturers Association, and the Proprietary
Association. At the hearing, however, a statement was submitted
on behalf of all four of these associations, indicating an agreement
on their part that the controversial provisions for administrative
listing of so-called dangerous drugs might be eliminated. The four
associations, at the same time, proposed two new amendments to
the bill. This agreement had the effect of eliminating one of the
principal areas of controversy, particularly in view of the fact that
the subcommittee was assured by the Food and Drug Administra-
tion and the Federal Security Administrator that the bill, while not
in their view the best solution, would be workable in the form pro-
posed under the agreement. The subcommittee recommended to
the Committee on Labor and Public Welfare, therefore, that the
provisions of the House bill which omit the administrative listing
provisions, rather than the provisions of the amendments in the
nature of a substitute for S. 1186 which include such provisions, be
favorably reported to the Senate. The subcommittee further recom-
mended, in reporting favorably on the House bill, that the bill be
amended to include the two amendments proposed by the associa-
tions of retail druggists and drug manufacturers under the agree-
ment referred to above. The intent and effect of these amendments
are discussed hereafter in this report.
2. The other principal area of controversy which developed at
the hearing arose with respect to certain language of the bill which
was objected to by the representative of a firm engaged in selling
through the mail to epileptic patients living throughout the United
States a medication comprised principally of phenobarbital. Al-
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1106 LEGAL COMPILATION—PESTICIDES
though the language in question was included in the legislation as
originally introduced in both the House of Representatives and the
Senate, in the bill as reported to the House of Representatives by
the House Interstate and Foreign Commerce Committee and in the
bill as passed in the House of Representatives, no issue had been
raised concerning this language prior to the hearing before the
subcommittee. The subcommittee, however, felt that the language
might safely be omitted from the bill. Accordingly, it proposed, and
the committee recommends, that this language be stricken. The
effect of this amendment is discussed elsewhere in this report.
WHAT THE BILL DOES
As has been pointed out, the bill amends the Federal Food, Drug,
and Cosmetic Act so that its provisions will be better adapted to
deal realistically with the labeling and dispensing of drugs that
may be sold only upon the prescription of licensed practitioners.
Its provisions are remedial in the sense that they are intended to
protect the public from abuses in the sale of potent prescription
medicines. They will also relieve retail pharmacists of unnecessary
restrictions on the dispensing of drugs that are safe for use with-
out medical supervision.
Prescription drugs
The bill provides a statutory definition of prescription drugs; it
expressly forbids their sale without a prescription; it specifies how
they are to be labeled both at the time of interstate shipment and
at the time of ultimate dispensing; and it prohibits unauthorized
refilling of prescriptions for them.
[p-3]
There are three classes of drugs covered by the statutory defini-
tion. The first includes the habit-forming drugs subject to section
502 (d) of the present statute. These are such drugs as the barbitu-
rates. The third class includes all new drugs restricted to pre-
scription sale by effective new-drug applications under section 505
of the present statute. There is no controversy whatever about
these two classes. The second class includes any drug which "be-
cause of its toxicity or other potentiality for harmful effect, or the
method of its use, or the collateral measures necessary to its use, is
not safe for use except under the supervision of a practitioner li-
censed by law to administer such drugs."
This definition of so-called dangerous drugs is contained in para-
graph (b) (1) (B) of the bill. It is substantially the same as the
administrative definition now contained in the regulations issued
by the Federal Security Administrator under the provisions of the
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STATUTES AND LEGISLATIVE HISTORY 1107
Federal Food, Drug, and Cosmetic Act. The proposed definition,
however, omits the reference to "efficacious" for use, as well as
"safe" for use, without the supervision of a medical practitioner in
order to be eligible for over-the-counter sale. This omission is not
intended to mean that the only matter to be considered in applying
the definition is whether or not a particular drug is poisonous.
The word "safe," as used in the definition, is intended to have its
ordinary meaning. For example, nontoxic drugs like quinidine sul-
fate, intended for heart disease, or penicillin, for infections, are not
safe for self-medication because their unsupervised use may indi-
rectly cause injury or death. The language of the definition clearly
shows that toxicity is only one factor to be considered by the courts
in determining whether a particular drug is safe for use without
medical supervision. The definition requires the court to consider
also other potentialities for harmful effect, the method by which
the drug is used, and the collateral measures that may be necessary
in order to use the drug safely. When this language is given judi-
cial interpretation consistent with the over-all purpose of the
Federal Food, Drug, and Cosmetic Act to protect the public health
it will effectively restrict to prescription sale all drugs that re-
quire professional supervison for their use.
In order to give this general definition a more precise meaning so
that it may be applied with greater uniformity by the drug trade
the Administrator can exercise the authority he has under section
701 (a) of the Federal Food, Drug, and Cosmetic Act to issue inter-
pretative regulations. It is to be understood that the inclusion of the
statutory definition does not, of course, in any way derogate from
the Administrator's authority to interpret and enforce the defini-
tion through the issuance of any regulations necessary or appro-
priate to protect the public from indiscriminate dispensing of drugs
over the counter when they may be unsafe for use without the
supervision of a practitioner licensed by law to administer such
drugs.
As previously stated, the committee considered S. 1186 together
with H. R. 3298. S. 1186 would have authorized the Federal Secur-
ity Administrator to list by name or class the drugs which he
considered within the statutory definition. The grant of such
administrative authority was objected to as an unnecessary regula-
tion of the drug industry, and the committee concluded that
administrative listing is not necessary at this time. It was felt that
[p. 4]
the statutory definition, together with the authority to make inter-
pretative regulations, could bring an end to the existing confusion
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1108 LEGAL COMPILATION—PESTICIDES
in drug labeling and that uniformity can be achieved through
cooperative efforts of the drug industry and the Food and Drug
Administration working under the statutory plan. If the present
confusion is not ended by this legislation it will then be time
enough to consider the need for the administrative listing
approach.
All drugs covered by the three classifications of prescription
drugs must bear a label containing the statement "Federal law
prohibits dispensing without prescription." This gives the retail
druggist clear notice that he will be in violation of the Federal
Food, Drug, and Cosmetic Act if he dispenses any drug so labeled
without a prescription. This bill also specifies what information
must be contained upon the label of the package dispensed to the
patient. That label must contain the name and address of the dis-
penser, the serial number and date of the prescription or of its fill-
ing, the name of the prescriber, and, if stated in the prescription,
the name of the patient, and the directions for use and cautionary
statements, if any, contained in the prescription.
This bill strengthens the controls over the habit-forming bar-
biturates. The problems of misuse of these drugs to the detriment
of the public—especially of young people—are growing and must
be controlled in the public interest. The bill requires that they be
sold only on prescription and forbids unauthorized refills of pre-
scriptions for them. In this, it is a definite and clear step forward.
It is felt, however, that these drugs pose a special problem not com-
mon to all drugs because they are desired by addicts for nonmedi-
cal use. This will call for their special treatment, and the committee
wishes it understood that in recommending the passage of this
bill, as amended, it does so with the knowledge that further legis-
lative consideration must be given to adequate barbiturate con-
trols.
The bill does not relieve any person from any requirements of
law, now existing or hereafter adopted, with respect to drugs
covered by the narcotic control laws. Paragraph (5) of section
1 makes this clear.
Oral prescriptions
The present law does not recognize the practice of dispensing
drugs on oral prescriptions. The committee feels that in this
respect the law needs modification and clarification for the con-
venience of the public, the retail druggist, and the physician.
The filling and refilling of prescriptions upon oral or telephone
orders with proper safeguards should be permitted, and this bill
gives statutory recognition to the practice of telephone dispensing.
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STATUTES AND LEGISLATIVE HISTORY 1109
It permits oral prescriptions for all drugs. However, in the case
of habit-forming' drugs, dangerous drugs, and new drugs limited
to prescription sale, an oral prescription would have to be reduced
promptly to writing and kept on file by the pharmacist. The oral
order may be communicated to the dispenser by the prescriber
himself or under his express authority.
Oral prescriptions for habit-forming drugs
The committee believes that the term "oral prescription," as
used in the bill in connection with habit-forming drugs to which
section 50 (d) of the act applies, should be given a construction
which will assure that these drugs are used only upon the express
order of a practitioner licensed by law to administer them. In fact,
[p. 5]
certain of these drugs, such as narcotics subject to the Harrison
Narcotics Act may be dispensed only on a written prescription of
a licensed practitioner, and this requirement is expressly preserved
by the bill. (See par. (5) of the new sec. 503 (b).) The public
interest clearly requires that other habit-forming drugs be dis-
pensed and used only under the close and immediate supervision
of a licensed practitioner. Accordingly, it is the intention of the
committee that the term "oral prescription" as applied to these
drugs, means an order communicated orally to the pharmacist
by a practitioner licensed by law to administer such drugs, ex-
pressly prescribing such a drug, which is reduced promptly to
writing and filed by the pharmacist. The Food and Drug Admin-
istration, within the limitations of its staffing, can check pharma-
cists' records to make sure that all habit-forming drugs sold are
accounted for by prescriptions on file. The pharmacist, before he
dispenses any such drug on oral order, must obtain satisfactory
evidence, on the basis of consultation with the licensed practitioner
or otherwise, that the order has been expressly authorized in each
case by such practitioner.
The Federal Security Agency may adopt regulations needed for
the efficient enforcement of this provision, and may find it desir-
able to require special records for any habit-forming drugs dis-
pensed so that pharmacists and enforcement officials alike can
readily detect any possible abuses of the oral prescription privilege
extended for such drugs.
Refilling prescriptions
The bill, as amended, deals expressly with the troublesome
problem of refilling prescriptions. Under the present law a drug
dispensed by refilling a prescription without the knowledge or
-------
1110 LEGAL COMPILATION—PESTICIDES
consent of the prescriber is misbranded and the dispenser is
liable to criminal prosecution. The committee concluded that
these provisions are too stringent and should be modified. There is
no reason why the law should prohibit the refilling of prescriptions
for drugs that are not dangerous and are suitable for use by a
layman without medical supervision. The bill provides that pre-
scriptions for such drugs may be freely refilled. But, here again,
as to drugs which are habit-forming, or which are dangerous, or
which are restricted by new drug applications to use under
medical supervision, the bill requires that prescriptions may be
refilled only with the prescriber's express authorization. This
authorization may be either written or oral, but if it is given orally
the dispenser must promptly reduce it to writing and keep it on
file.
The provisions relating to the refilling of prescriptions are
needed to meet a serious public health problem which has arisen
from the indiscriminate refilling of prescriptions for dangerous
and habit-forming drugs. A witness for the Food and Drug Ad-
ministration cited cases in which death had occurred as a conse-
quence of unauthorized prescription refills. The use of dangerous
and habit-forming drugs must be under the supervision of the
prescribing physician. This bill is intended to require that the
licensed practitioner, if he has not authorized the refill in writing,
be consulted by the pharmacist and the refill be authorized by such
practitioner before any prescription for a drug that is limited
to prescription sale may be refilled. r _,
[p. bj
EFFECT OF COMMITTEE AMENDMENTS
Amendment (1) was proposed by a firm engaged in selling
through the mails to epileptic patients living throughout the
United States a medication comprised principally of phenobar-
bital. Other provisions of the bill, to which the firm did not object,
clarify and simplify the provisions of existing law regarding the
labeling, sale, and dispensing of habit-forming and other dan-
gerous drugs that should be sold only on prescription. These pro-
visions are adequate to enable the Food and Drug Administration
to compel such firms through appropriate court action, if neces-
sary, to operate in a manner consistent with the public interest.
The committee is aware of the obvious dangers to the public
interest in the sale of barbiturates, including phenobarbital, with-
out immediate and close medical supervision. The Food and Drug
Administration has a responsibility in connection with the elim-
ination of such dangers. This bill greatly strengthens the Admin-
istration's hand in discharging that responsibility.
-------
STATUTES AND LEGISLATIVE HISTORY nil
The other two amendments were proposed by the combined
drug: trade in a statement signed by the National Association of
Retail Druggists, the American Pharmaceutical Manufacturers'
Association, the American Drug Manufacturers Association, and
the Proprietary Association.
Amendment (2) was recommended because the associations felt
the language it strikes out was of uncertain meaning and added
nothing of importance to the bill. In any event, should a person
place a statement on the label of a drug entirely safe for self-
medication representing or implying that dispensing it without a
prescription is prohibited by Federal law, that drug would be
misbranded under the provision of law, section 502 (a), which
forbids false or misleading labeling statements. Striking the lan-
guage objected to does not relieve any manufacturer, regardless
of the way in which he does business, from compliance with the
requirement of section 502 (f) that all drugs not limited to pre-
scription sale must bear adequate warnings and adequate direc-
tions for use telling the purchasing public what the drug is to
be used for and how it is to be taken to accomplish the beneficial
effects it is intended to have.
Amendment (3) was proposed to emphasize the fact that the
responsibility for preparing adequate directions for use and appro-
priate warnings against misuse in the labeling of drugs that may
be sold without a prescription is upon the manufacturer and not
the retail druggist. It does nothing more than free the retail drug-
gist of responsibility for supplementing the labeling of some
manufacturers' drugs to give the public adequate directions for
use and warnings against misuse. The druggist could rely in good
faith upon the manufacturers' labeling for compliance with these
requirements of the existing law. The amendment offers the drug-
gist no protection against violations which arise if he sells a
dangerous drug covered by paragraph (1) of the bill without
meeting the prescription requirements.
Amendment (4) is a technical renumbering amendment.
EFFECTIVE I>ATE
Section 3 of the amended bill provides that its provisions shall
take effect 6 months after the date of its enactment. This post-
[p.7]
ponement of the effective date is considered necessary to permit
manufacturers to meet the new labeling requirements.
SECTIONAL ANALYSIS
Section 1 of the bill amends the Federal Food, Drug, and Cos-
-------
1112 LEGAL COMPILATION—PESTICIDES
metic Act by substituting for subsection (b) of section 503, relat-
ing to the labeling and dispensing of prescription drugs, a new
subsection defining drugs that may be dispensed only on prescrip-
tion and specifying the conditions under which such drugs may be
dispensed.
Prescription drugs
Under paragraph (1) of the new subsection (b) prescription
drugs are defined as drugs intended for use by man which fall
within any one of three different categories. In limiting prescrip-
tion drugs to those intended for use by man this new subsection
differs from the present law, which refers to prescription drugs
to include not only those dispensed on prescription of physicians
and dentists, but also those dispensed on prescription of a veter-
inarian. Under the committee bill, drugs intended for use under
the supervision of a veterinarian will not require a prescription,
although it will be possible under section 502 (f) to exempt such
drugs from adequate directions for use if they are to be used by
or under the supervision of a veterinarian. In the absence of any
exempting regulations, these drugs will be subject to the labeling
and dispensing requirements of the act applicable to over-the-
counter drugs.
The three categories of prescription drugs defined as such in the
bill are: (a.) habit-forming drugs to which section 502 (d) of the
act relating to drugs containing any narcotic or hypnotic sub-
stance, including barbituric acid, or habitxforming chemical deriva-
tives thereof, is applicable; (6) drugs which, because of their
toxicity or other potentiality for harmful effect, or the methods
of their use, or the collateral measures necessary to their use, are
not safe for use except under the supervision of a practitioner
licensed by law to administer such drugs; or (c) drugs which are
limited by an effective application under section 505 of the act,
relating to new drugs, to use under professional supervision.
Included in the first of these three categories are not only the
habit-forming narcotics and chemical derivatives thereof, but also
barbituric acid and its habit-forming derivatives, such as amytal,
phenobarbital, pentobarbital, and the like. This category includes
all of the drugs and derivatives thereof specified in section 502 (d)
of the act and the regulations thereunder. Dispensing of these
drugs must not only comply with the provisions of the bill, but
also must conform to the requirements of that section, and the
interstate label must bear the name and quantity or proportion of
the habit-forming drug or derivatives and in juxtaposition there-
with the statement: "Warning—May be habit forming."
-------
STATUTES AND LEGISLATIVE HISTORY 1113
The second category of prescription drugs, denned in subpara-
graph (B) of paragraph (1) of the new subsection (b) includes
the so-called dangerous drugs. As noted elsewhere in this report,
the phrase "not safe," as used in this subparagraph, is intended
to have its ordinary meaning. Furthermore, in determining
whether a drug is safe for use without medical supervision, there
must be taken into consideration not only the drug's toxicity, but
[p. 8]
also other potentialities for harmful effect, the method by which
it is used, and the collateral measures necessary to its safe use.
The broad language of the definition contained in this subpara-
graph is intended to comprehend all drugs that in fact should be
administered under medical supervision in order to insure their
safe use. Such difficult borderline cases as may arise under this
definition can be dealt with under the interpretative and rule-
making power provided for in section 701 (a) of the act.
The third category of drugs defined as "prescription" drugs
includes all new drugs restricted to prescription sale by effective
new drug applications under section 505 of the act,
Written and oral prescriptions and refills
Paragraph (1) of the new subsection (b) also provides that a
"prescription" drug (any drug falling in any one of the three cate-
gories referred to above) shall be dispensed only (1) upon a writ-
ten prescription of a practitioner licensed by law to administer
such drug, or (2) upon an oral prescription of such a practitioner,
communicated by him or under his express authority to the phar-
macist, if such prescription is promptly reduced to writing and
filed by the pharmacist, or (3) by refilling any such written or oral
prescription if such refilling is authorized by or under the express
authority of the practitioner either in the original prescription or
by oral order, which is reduced promptly to writing and filed by the
pharmacist. The provisions with respect to oral prescriptions and
refills do not apply, however, in the case of narcotics subject to
the Internal Revenue Code (Harrison Narcotic Act), since sub-
paragraph (5) of the new subsection (b) expressly safeguards
the provisions of that act, and under those provisions and the
regulations of the Bureau of Narcotics such drugs may be dis-
pensed only on written prescription. Also, as pointed out else-
where, with respect to other habit-forming drugs, oral prescrip-
tions and refills are limited to situations in which the pharmacist
obtains satisfactory evidence, on the basis of consultation with a
licensed practitioner or otherwise, that the prescription or refill
has been expressly authorized by such practitioner. A violation
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1114 LEGAL COMPILATION—PESTICIDES
of the prescription requirements of paragraph (1) of the new
subsection (b) is, under the provisions of this paragraph, deemed
to be an act which results in the drug being misbranded while held
for sale.
Labeling of'prescription drugs
Paragraph (2) of the new subsection (b) provides that a drug
dispensed on prescription shall be exempt from the provisions
of the act relating to the misbranding of drugs except those which
specify that a drug shall be deemed to be misbranded if its labeling
is false or misleading in any particular (sec. 502 (a) ), if it is an
imitation of another drug or is offered for sale under the name of
another drug (sec. 502 (i) (2) and (3) ), if it is, or purports to
be, or is represented as a drug composed wholly or partly of insu-
lin or of penicillin or certain other antibiotics except under certain
conditions (sec. 502 (k) and (1) ). These provisions continue to
apply to any drug subject to the act, whether sold over-the-counter
or on prescription. Similarly, the packaging requirements set
forth in section 502 (g) and (h) apply to all such drugs. Pres-
cription drugs must, however, bear at the time of dispensing a
label containing the name and address of the dispenser, the serial
[p. 9]
number and the date of the prescription or of its filling, the name
of the practitioner, if stated in the prescription the name of the
patient, and the directions for use and cautionary statements, if
any, stated in the prescription. The exemption provided for by
this paragraph does not apply to any drug dispensed in the course
of the conduct of a business of dispensing drugs pursuant to diag-
nosis by mail, or to a drug dispensed in violation of paragraph (1)
of the subsection.
Exempt narcotics and similar drugs
Under paragraph (3) of the new subsection (b) the Adminis-
trator may by regulation remove habit-forming drugs, as defined
in section 502 (d), and new drugs, from the prescription require-
ments contained in paragraph (1) of the subsection when these
requirements are not necessary for the protection of the public
health.
Prescription legend
Paragraph (4) of the new subsection requires that in addition
to the labeling requirements in the case of prescription drugs spe-
cified in paragraph (2) of the subsection, the interstate label on
such drugs must bear the statement "Caution: Federal law pro-
hibits dispensing without prescription." On the other hand, over-
-------
STATUTES AND LEGISLATIVE HISTORY 1115
the-counter drugs are forbidden to bear a label containing this
caution statement. A prescription drug, the label on which does
not bear the specified caution statement, is deemed to be mis-
branded. So too, is an over-the-counter drug, the label on which
bears this or a substantially similar statement.
Narcotics and marihuana
Paragraph (5) of the new subsection provides that compliance
with the requirements of the bill does not relieve any person from
any other requirement prescribed by or under authority of law
with respect to drugs now or hereafter within the classifications
defined in the Harrison Narcotic Act (sec. 3220 of the Internal
Revenue Code, 26 U.S.C. 3220), or marihuana, as defined in sec-
tion 3238 (b) of the Internal Revenue Code (26 U.S.C. 3238 (b)
of the Internal Revenue Code (26 U.S.C. 3238 (b)).
Good faith defense for retail druggists
Section 2 of the bill amends section 303 of the act, which speci-
fies the penalties applicable to violations of the act. It adds to the
several defenses available under subsection (c) of section 303 a
new defense which has the effect of relieving from liability because
of misbranding under section 502 (f) of the act any dispenser
who makes delivery or proffers delivery of a drug in good faith
if the labeling on such drug at the time of such delivery or prof-
fered delivery contained the same directions for use and warning
statements as were contained in the labeling at the time of receipt
of the drug by such dispenser. This defense, however, is not
applicable in the case of a drug which, in accordance with the
practice of the trade, is to be processed, labeled, or repacked in
substantial quantities at establishments other than those where
originally processed or packed, and is not applicable to a pre-
scription drug.
Effective date
Section 3 contains an effective date provision. In order to enable
the drug industry to adapt its operations to the requirements
specified in the bill, and to give the Food and Drug Administration
[p. 10]
time in which to develop procedures necessary to implement
administration of the bill, it is provided that the provisions of the
bill will not go into effect until 6 months have elapsed after the
date of its enactment.
CHANGES IN EXISTING LAW
In compliance with subsection 4 of rule XXIX of the Standing
Rules of the Senate, changes in the existing law made by the bill
-------
1116 LEGAL COMPILATION—PESTICIDES
are shown as follows: (Existing law proposed to be omitted is
enclosed in black brackets; new matter is printed in italics, exist-
ing law in which no change is proposed is shown in roman).
FEDERAL FOOD, DRUG AND COSMETIC ACT
PENALTIES
SEC. 303. (a) Any person who violates any of the provisions of section 301
shall be guilty of a misdemeanor and shall on conviction thereof be subject to
imprisonment for not more than one year, or a fine of not more than $1,000, or
both such imprisonment and fine; but if the violation is committed after a
conviction of such person under this section has become final such person shall
be subject to imprisonment for not more than three years, or a fine of not
more than $10,000, or both such imprisonment and fine.
(b) Notwithstanding the provisions of subsection (a) of this section, in
case of a violation of any of the provisions of section 301, with intent to
defraud or mislead, the penalty shall be imprisonment for not more than
three years, or a fine of not more than $10,000, or both such imprisonment
and fine.
(c) No person shall be subject to the penalties of subsection (a) of this
section, (1) for having received in interstate commerce any article and deliv-
ered it or proffered delivery of it, if such delivery or proffer was made in good
faith, unless he refuses to furnish on request of an officer or employee duly
designated by the Administrator the name and address of the person from
whom he purchased or received such article and copies of all documents, if
any there be, pertaining to the delivery of the article to him; or (2) for hav-
ing violated section 301 (a) or (d), if he establishes a guaranty or under-
taking signed by, and containing the name and address of, the person resid-
ing in the United States from whom he received in good faith the article, to
the effect, in case of an alleged violation of section 301 (a), that such article
is not adulterated or misbranded, within the meaning of this Act, designating
this Act, or to the effect, in case of an alleged violation of section 301 (d),
that -such article is not an article which may not, under the provisions of
section 404 or 505, be introduced into interstate commerce; or (3) for having
violated section 301 (a), where the violation exists because the article is adul-
terated by reason of containing a coal-tar color not from a batch certified in
accordance with regulations promulgated by the Administrator under this
Act, if such person establishes a guaranty or undertaking signed by, and con-
taining the name and address of, the manufacturer of the coal-tar color, to
the effect that such color was from a batch certified in accordance with the
applicable regulations promulgated by the Administrator under this Act;
of (4) for having violated section SOI (b), (c) or (k) by failure to comply
with section 502 (f) in respect to an article received in interstate commerce
to which neither section SOS (a) nor section 503 (b) (1) is applicable, if the
delivery or proffered delivery was made in good faith and the labeling at the
time thereof contained the same directions for use and warning statements
as were contained in the labeling at the time of such receipt of such article.
EXEMPTIONS IN CASE OF DRUGS AND DEVICES
SEC. 503. (a) The Administrator is hereby directed to promulgate regula-
tions exempting from any labeling or packing requirement of this Act drugs
and devices which are, in accordance with the practice of the trade, to be proc-
-------
STATUTES AND LEGISLATIVE HISTORY 1117
essed, labeled, or repacked in substantial quantities at establishments other
than those where originally processed or packed, on condition that such drugs
and devices are not adulterated or misbranded under the provisions of this
Act upon removal from such processing, labeling, or repacking establishment.
[p.ll]
[ (b) A drug dispensed on a written prescription signed by a physician, den-
tist, or veterinarian (except a drug dispensed in the course of the conduct of
a business of dispensing drugs pursuant to diagnosis by mail), shall if—
(1) such physician, dentist, or veterinarian is licensed by law to admin-
ister such drug, and
(2) such drug bears a label containing the name and place of business
of the dispenser, the serial number and date of such prescription, and
the name of such physician, dentist, or veterinarian,
be exempt from the requirements of section 502 (b) and (e), and (in case
such prescription is marked by the writer thereof as not refillable or its refil-
ling is prohibited by law) of section 502 (d).]
(b) (1) A drug intended for use by man which—
(A) is a habit-forming drug to which section 502 (d) applies; or
(B) because of its toxicity or other potentiality for harmful effect, or
the method of its use, or the collateral measures necessary to its use, is
not safe for use except under the supervision of a practitioner licensed
by law to administer such drug; or
(C) is limited by an effective application under section 505 to use
under the professional supervision of a practitioner licensed by law to
administer such drug,
shall be dispensed only (i) upon a written prescription of a practitioner
licensed by law to administer such drug, or (ii) upon an oral prescription of
such practitioner which is reduced promptly to writing and filed by the phar-
macist, or (Hi) by refilling any such written or oral prescription if such refil-
ling is authorized by the prescriber either in the original prescription or by
oral order which is reduced promptly to writing and filed by the pharmacist.
The act of dispensing a drug contrary to the provisions of this paragraph
shall be deemed to be an act which results in the drug being misbranded
while held for sale.
(2) Any drug dispensed by filling or refilling a written or oral prescrip-
tion of a practitioner licensed by law to administer such drug shall be
exempt from the requirements of section SOS, except paragraphs (a), (i)
(2) and, (S), (k), and (I), and the packaging requirements of paragraphs
(g) and (h), if the drug bears a label containing the name and address of the
dispenser, the serial number and date of the prescription or of its filling, the
name of the prescriber, and, if stated in the prescription, the name of the
patient, and the directions for use and cautionary statements, if any, con-
tained in such prescription. This exemption shall not apply to any drug dis-
pensed in the course of the conduct of a business of dispensing drugs pur-
suant to diagnosis by mail, or to a drug dispensed in violation of paragraph
(1) of this subsection.
(3) The Administrator may by regulation remove drugs subject to section
502 (d) and section 505 from the requirements of paragraph (1) of this sub-
section when such requirements are not necessary for the protection of the
public health.
(It) A drug which is subject to paragraph (1) of this subsection shall be
-------
1118
LEGAL COMPILATION—PESTICIDES
deemed to be misbranded if at any time prior to dispensing its label fails to
bear the statement "Caution: Federal law prohibits dispensing without pres-
cription". A drug to which paragraph (1) of this subsection does not apply
shall be deemed to be misbranded if at any time prior to dispensing its label
bears the caution statement quoted in the preceding sentence.
(5) Nothing in this subsection shall be construed to relieve any person
from any requirement prescribed by or under authority of law with respect
to drugs now included or which may hereafter be included within the classi-
fications stated in section S220 of the Internal Revenue Code (26 U. S. C.
3220), or to marihuana as defined in section 3238 (b) of the Internal Revenue
Code (26 U. S. C. S2S8 (b) ). [p. 12]
1.13c (3) CONGRESSIONAL RECORD, VOL. 97 (1951)
1.13c (3) (a) Aug. 1: Amended and passed House, pp. 9333,9334
[No Relevant Discussion on Pertinent Section]
1.13c (3) (b) Oct 15: Amended and passed Senate, pp. 13126,13128,
13131
AMENDMENT OF SECTION
503 (B) FEDERAL FOOD, DRUG,
AND COSMETIC ACT
Mr. McFARLAND. Mr. President, I
move that the Senate proceed to the
consideration of the bill (H. R. 3298) to
amend section 503 (b) of the Federal
Food, Drug, and Cosmetic Act.
The PRESIDING OFFICER. The
question is on the motion of the Sena-
tor from Arizona.
The motion was agreed to; and the
Senate proceeded to consider the bill,
which had been reported from the Com-
mittee on Labor and Public Welfare,
with amendments.
[p.13126]
Mr. CASE. I believe the Senator has
said that the bill comes before the Sen-
ate with the unanimous support of the
Committee on Labor and Public Wel-
fare.
Mr. HUMPHREY. That is correct.
The PRESIDING OFFICER. The
clerk will state the committee amend-
ments.
The amendments were, on page 3,
line 4, after the word "by", to strike
out "mail or otherwise without exam-
ination of the patient" and insert
"mail"; in line 11,after the word "the",
to strike out "production" and insert
"protection"; in line 20, after the word
"sentence", to strike out "or any other
statement which represents or implies
that the dispensing of the drug with-
out the prescription of a licensed prac-
titioner" ; on page 4, after line 6, to in-
sert:
SEC. 2. Subsection (c) of section SOS of the
Federal Food, Drug, and Cosmetic Act, as
amended, is amended by striking out the period
at the end of clause (3) and inserting in lieu
thereof a semicolon and the following: "or (4)
for having violated section 301 (b), (c) or (k)
by failure to comply with section B02 (f) in
respect to an article received in interstate
commerce to which neither section 503 (a) nor
section 503 (b) (1) is applicable, if the delivery
or proffered delivery was made in good faith
and the labeling at the time thereof contained
the same directions for use and warning state-
ments as were contained in the labeling at the
time of such receipt of such article."
And in line 19, to change the section
number from "2" to "3."
The amendments were agreed to.
The PRESIDING OFFICER. The
bill is open to further amendment.
Mr. HUMPHREY. Mr. President, I
want to offer an amendment with re-
gard to changing the title of the bill.
The PRESIDING OFFICER. That
does not have to be done at this time.
-------
STATUTES AND LEGISLATIVE HISTORY
1119
The question is on the engrossment
of the amendments and the third read-
ing of the bill.
The amendments were ordered to be
engrossed, and the bill to be read a
third time.
The bill was read the third time, and
passed.
[p.13128]
Mr.HUMPHERY subsequently said:
Mr. President, I move that the Senate
insist upon its amendments, ask for a
conference with the House thereon, and
that the Chair appoint the conferees
on the part of the Senate.
The motion was agreed to; and the
Presiding Officer appointed Mr. LEH-
MAN, Mr. HUMPHREY, and Mr. IVES
conferees on the part of the Senate.
[p.13131]
1.13c (3) (c)
p. 13378
TO AMEND SECTION 503 (B) OP
THE FEDERAL FOOD, DRUG,
AND COSMETIC ACT
Mr. GROSSER. Mr. Speaker, I ask
unanimous consent to take from the
Speaker's table the bill (H. R. 3298)
an act to amend section 503 (b) of the
Federal Food, Drug, and Cosmetic Act,
with Senate amendments, and concur
in the Senate amendments.
The Clerk read the title of the bill.
The Clerk read the Senate amend-
ments, as follows:
Page 3, lines 4 end 5, strike out "mail or
otherwise without examination of the patient"
and insert "mail."
Page 3, line 19, strike out all after "sentence"
down to and including "prohibited" in lines 21
and 22.
Page 4, after line 5, insert:
"SEC. 2. Subsection (c) of section 303 of the
Federal Food, Drug, and Cosmetic Act, as
amended, is amended by striking out the period
at the end of clause (3) and inserting in lieu
Oct. 17: House concurs in Senate amendments,
thereof a semicolon and the following: 'or (4)
for having violated section 301 (b), (c) or (k)
by failure to comply with section 602 (f) in
respect to an article received in interstate com-
merce to which neither section 603 (a) nor sec-
tion 603 (b) (1) is applicable, if the delivery or
proffered delivery was made in good faith and
the labeling at the time thereof contained the
same directions for use and warning statements
as were contained in the labeling at the time of
such receipt of such article'."
Page 4, line 6, strike out "2" and insert "3."
Amend the title so as to read: "An act to
amend sections 303 (c) and 603 (b) of the
Federal Food, Drug, and Cosmetic Act, as
amended."
The SPEAKER. Is there objection to
the request of the gentleman from Ohio
[Mr. GROSSER] ?
There was no objection.
The Senate amendments were con-
curred in.
A motion to reconsider was laid on
the table.
[p.13378]
1.13d 1953 REORGANIZATION PLAN I, §§5, 8, 67 STAT. 632
SEC. 5. Transfers to the Department.—All functions of the Fed-
eral Security Administrator are hereby transferred to the Secre-
tary. All agencies of the Federal Security Agency, together with
their respective functions, personnel, property, records, and unex-
pended balances of appropriations, allocations, and other funds
(available or to be made available), and all other functions, per-
sonnel, property, records, and unexpended balances of appropria-
tions, allocations, and other funds (available or to be made availa-
ble) of the Federal Security Agency are hereby transferred to the
Department.
SEC. 6. Performance of Functions of the Secretary.—The Secre-
tary may from time to time make such provisions as the Secretary
-------
1120 LEGAL COMPILATION—PESTICIDES
deems appropriate authorizing the performance of any of the
functions of the Secretary by any other officer, or by any agency
or employee, of the Department.
SEC. 7. Administrative Services.—In the interest of economy
and efficiency the Secretary may from time to time establish central
administrative services in the fields of procurement, budgeting,
accounting, personnel, library, legal, and other services and activi-
ties common to the several agencies of the Department; and the
Secretary may effect such transfers within the Department of the
personnel employed, the property and records used or held, and
the funds available for use in connection with such administrative
service activities as the Secretary may deem necessary for the con-
duct of any services so established: Provided, That no professional
or substantive function vested by law in any officer shall be
removed from the jurisdiction of such officer under this section.
[p. 632]
1.13e FOOD COLORING AMENDMENTS OF 1960
July 12, I960, P.L. 86-618, Title I, §105(b), 74 Stat. 403
CHANGES IN CROSS-REFERENCES AND TERMINOLOGY
SEC. 105. Such Act is further amended by—
(a) striking out, in section 301 (i) thereof (relating to for-
gery or unauthorized use of certain identification devices),
"404, 406 (b), 504, 506, 507, or 604", and inserting in lieu
thereof "404,506,507, or 706";
(b) (1) striking out, in clause (3) of section 303 (c) relat-
ing to color manufacturer's guarantee), the word "coal-tar"
wherever it appears in such clause, and (2) inserting after
the word "color", wherever it appears in such clause, the word
[p. 403]
"additive"; and
(c) striking out "harmless coloring" in section 402 (d)
(relating to nonnutritive substances in confectionery) and
inserting in lieu thereof "authorized coloring".
[p. 404]
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STATUTES AND LEGISLATIVE HISTORY 1121
1.13e (1) SENATE COMMITTEE ON LABOR AND PUBLIC
WELFARE
S. REP. No. 795, 86th Cong., 1st Sess. (1959)
COLOR ADDITIVE AMENDMENTS OF 1959
AUGUST 21,1959.—Ordered to be printed
Mr. HILL, from the Committee on Labor and Public Welfare,
submitted the following
REPORT
[To accompany S. 2197]
The Committee on Labor and Public Welfare, to whom was
referred the bill (S. 2197) to protect the public health by amend-
ing the Federal Food, Drug, and Cosmetic Act so as to authorize
the use of suitable color additives in or on foods, drugs, and cos-
metics, in accordance with regulations prescribing the conditions
(including maximum tolerances) under which such additives may
be safely used, having considered the same, report favorably there-
on with amendments and recommend that the bill, as amended,
do pass.
EXPLANATION
S. 2197 is designed to better protect the public health with
respect to procedures necessary to assure the safety of color addi-
tives in foods, drugs, and cosmetics and to authorize the use of
such color additives as have been predetermined to be perfectly
safe in the amounts in which they are to be used. The bill is
designed to meet a pressing need for replacing the inconsistent,
and in part outmoded, provisions which now govern the use of
different kinds of color for articles covered by the Federal Food,
Drug, and Cosmetic Act with a scientifically sound and uniform
system for the listing of color additives of any kind which may
be safely used in foods, drugs, or cosmetics, subject, when neces-
sary, to appropriate tolerance limitations and other conditions of
use and to official certification of batches of color so as to assure
the safety of such use to the consumer.
Under existing law coal-tar colors may not be used in foods,
drugs, or cosmetics unless they have been certified by the Food and
Drug Administration as harmless and suitable for use. A recent
Supreme Court decision has defined the "harmless" principle as
meaning harmless regardless of the quantity of the coal-tar color
which is being used. Thus, a color must be decertified if any quan-
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1122 LEOAL COMPILATION—PESTICIDES
tity or concentration of the color is harmful, even though in lesser
[p.l]
concentrations it may be perfectly safe. Because of this principle,
as defined by the Supreme Court, it has been necessary for the
Food and Drug Administration to withdraw certification of seven
food colors. Seventeen additional colors have been proposed for
delisting. The effect of the application of the "harmless" principle
in terms of existing law is to cause many of the coal-tar colors
widely used in industry to be no longer available, and the number
of colors withdrawn will eventually seriously handicap manufac-
turers of foods, drugs, and cosmetics in the production of products
in the manner that is customary and usual.
Many food industries find themselves seriously affected by the
delisting of colors. If additional proposed delistings are accom-
plished, similar effect is faced by drug and cosmetic industries. The
very existence of many products depends upon the use of suitable
color.
This legislation is necessary, because it will give the Secretary
of Health, Education, and Welfare a flexibility, which he does not
have under the present law, to certify coal-tar colors within toler-
ance limits which he determines are safe.
Two amendments to the bill as originally introduced were
adopted by the committee. Both amendments were developed
cooperatively by the committee staff, representatives of the indus-
tries concerned, and representatives of the Food and Drug Admin-
istration. Both have been declared acceptable by the Administra-
tion and by industry. Their objectives are, first, to permit those
additives found "safe" by the Secretary under the procedures set
forth in the Food Additives Amendments Act of 1958 to be con-
sidered "safe" when used as color additives, and, secondly, to
relieve the Administration from the obligation of requiring the use
of certain analytical methods, when, in its opinion, they are not
needed.
The bill as amended has the endorsement of the Administration
and of the following business groups which have concerned them-
selves with the legislation: The Certified Color Industry Commit-
tee, the Toilet Goods Association, the National Association of Mar-
garine Manufacturers, the International Association of Ice Cream
Manufacturers, the Grocery Manufacturers of America, and the
National Confectioners Association.
S. 2197 was introduced at the request of the Department of
Health, Education, and Welfare with the approval of the Bureau
of the Budget. r 01
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STATUTES AND LEGISLATIVE HISTORY 1123
[Arthur S. Flemming, Secretary, Department of Health, Educa-
cation, and Welfare]
"3. There is a need for making applicable to all color uses and all
types of color — whether they be coal-tar colors or others — the
same pretesting requirements and, where necessary for the pro-
tection of color users and consumers, the same requirement for cer-
tification of colors to assure their purity and identity with those
listed as safe. At present there are no provisions for the certifica-
tion of non-coal-tar colors; there is, moreover, no pretesting
requirement for non-coal-tar color additives as such, other than
food additives." ,- ,-,
The technical provisions and approach of this bill are summa-
rized in detail in the section-by-section analysis which follows.
SECTION-BY-SECTION ANALYSIS OP "COLOR ADDITIVE
AMENDMENTS OF 1959"
I. INTRODUCTION
Under existing law, so-called coal-tar colors are regulated under
the Federal Food, Drug, and Cosmetic Act through similar sets of
provisions in chapters IV (food), V (drugs), and VI (cosmetics).
Food containing a coal-tar color is deemed adulterated by section
402 (c) of the act unless the color is from a batch certified by the
Secretary under section 406; section 406 (b) then directs the Secre-
tary to provide for listing coal-tar colors that are harmless and
suitable for use in food, and to provide for certifying batches of
such colors. A drug containing a coal-tar color solely for coloring
purposes is deemed adulterated by section 501 (a) (4) unless the
color is from a batch certified by the Secretary under section 504;
section 504 then directs the Secretary to provide for listing coal-tar
colors that are harmless and suitable for use in drugs for purposes
of coloring only, and for certifying batches of such colors. A cos-
metic (other than a hair dye (defined to exclude eyelash and eye-
brow dyes)) containing a coal-tar color is deemed adulterated by
section 601 (e) unless the color is from a batch certified by the Sec-
retary under section 604; section 604 then directs the Secretary
to provide for listing coal-tar colors that are harmless and suitable
for use in cosmetics, and for certifying batches of such colors.
Food colors which are not coal-tar colors are, when not generally
recognized by experts as safe, regulated as "food additives" under
the Food Additives Amendment of 1958 (Public Law 85-929).
Under section 402 (a) (2) (C) of the act, a food which is, bears, or
contains a "food additive" is deemed adulterated if the additive is
unsafe within the meaning of section 409; and under section 409,
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1124 LEGAL COMPILATION — PESTICIDES
the food additive is deemed unsafe unless it and its use (or
intended use) conform to a regulation under section 409 announc-
ing the conditions under which the additive may be safely used.
The present bill takes "color additives" out of the scope of the
Food Additives Amendment of 1958; repeals the present provi-
sions for the listing and certification of "harmless" coal-tar colors
(sees. 406 (b) , 504, and 604) ; enacts new, integrated provisions for
the separate listing of suitable "color additives" safe for use in
food, drugs, or cosmetics, under such conditions (including toler-
ance limitations) as the Secretary may find necessary to assure
the safety of the uses permitted ; provides for the certification (or
exemption from certification) of listed color additives for such per-
mitted uses ; adapts the adulteration and other provisions of the
act to the substantive and other changes involved in the above-
mentioned changes ; and contains transitional provisions for com-
mercially established colors.
r
Lp.
Section 105
Contains appropriate changes of cross-references in, and other
conforming amendments to, sections 301 (i) (false use of required
marks), 303 (c) (3) (guarantee that coal-tar color is certified),
and 402 (d) (nonnutritive substances in confectionery) of the
basic act. .- ^-.
1.13e (2) HOUSE COMMITTEE ON INTERSTATE AND FOR-
EIGN COMMERCE
H.R. REP. No. 1761, 86th Cong., 2d Sess. (1960)
COLOR ADDITIVE AMENDMENTS OF 1960
JUNE 7, 1960.—Committed to the Committee of the Whole House on the State
of the Union and ordered to be printed
Mr. HARRIS, from the Committee on Interstate and Foreign
Commerce, submitted the following
REPORT
[To accompany H.R. 7624]
The Committee on Interstate Foreign Commerce, to whom was
referred the bill (H.R. 7624) to protect the public health by
amending the Federal Food, Drug, and Cosmetic Act so as to
authorize the use of suitable color additives in or on foods, drugs,
and cosmetics, in accordance with regulations prescribing the con-
ditions (including maximum tolerances) under which such addi-
-------
STATUTES AND LEGISLATIVE HISTORY 1125
tives may be safely used, having considered the same, report favor-
ably thereon with amendments and recommend that the bill as
amended do pass. r 1,
PURPOSE OF LEGISLATION
The purpose of this bill is to protect the public health by amend-
ing the Federal Food, Drug, and Cosmetic Act so as to authorize
the use of suitable color additives in or on foods, drugs, and cos-
metics in accordance with regulations to be issued by the Secre-
tary of Health, Education, and Welfare, prescribing the conditions,
including maximum tolerances, under which such additives may be
safely used.
GENERAL SUMMARY
The committee bill—
(1) takes "color additives" out of the scope of the Food
Additives Amendment of 1958;
(2) repeals the present provisions of the Federal Food,
Drug, and Cosmetic Act for the listing and certification of
"harmless" coal-tar colors (sees. 406 (b), 504, and 604) ;
(3) enacts new, integrated provisions for the separate
listing of suitable "color additives," safe for use in food, drugs,
or cosmetics, under such conditions (including tolerance limi-
tations) as the Secretary of Health, Education, and Welfare
may find necessary to assure the safety of the uses permitted;
(4) provides for the certification (or exemption from certi-
fication) of listed color additives for such permitted uses;
(5) adapts the adulteration and other provisions of the
Federal Food, Drug, and Cosmetic Act to the substantive and
other changes involved in the above-mentioned changes; and
(6) contains transitional provisions for commercially estab-
lished colors.
HEARINGS
Extensive hearings were held by the committee on this legisla-
tion in January, February, March, and May 1960 and a large num-
ber of witnesses were heard. The committee also heard from a dis-
tinguished group of scientific experts, selected by the President
of the National Academy of Sciences, which discussed the scien-
tific problems involved in this legislation, with special emphasis
on the Delaney anticancer clause.
[p. 6]
5. Certification and exemptions from certification.—While pro-
viding for certification of batches of listed colors, as existing law
does for coal-tar colors, the bill would permit the Secretary to
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1126 LEGAL COMPILATION—PESTICIDES
grant exemptions from the requirement of certification where cer-
tification is not necessary to protect the public health. The present
requirement of certification for coal-tar colors is intended to assure
food processors and housewives that the color is free from toxic
impurities and otherwise complies with regulations defining the
color's identity. The committee agrees with the Secretary of
Health, Education, and Welfare, however, that authority to
exempt colors from the certification requirement is desirable, espe-
cially since the coverage of the law is broadened to include all types
of substances capable of imparting color.
[p. 15]
(2) Color additives exempted under Food Additives Amend-
ment (p. 9, beginning on line 8 of reported bill)
This committee amendment revises proposed section 706 (b) (4)
by transferring the provisions of subparagraphs (B) and (C)
thereof, in consolidated and modified form, to proposed section
706 (b) (5) (see discussion immediately below) and adding a pro-
viso to the revised section 706 (b) (4) providing that a color addi-
tive shall be deemed to be suitable and safe for listing for use
generally in or on food while there is in effect a published finding
by the Secretary declaring that such additive is exempt under the
Food Additives Amendment of 1958 because of its being generally
recognized by qualified experts as safe for its intended use as pro-
vided in section 201 (s) of the act.
(3) Analytical methods for color additives (p. 11, beginning on
line 1 of reported bill)
This committee amendment adds a new subparagraph (iv) to
proposed section 706 (b) (5) (A) in the bill, which consolidates and
modifies the provisions of subparagraphs (B) and (C) of proposed
section 706 (b) (4) in the bill as introduced. These subsections deal
[p. 18]
with practicable methods of analysis for color additives and for
determining the identity and quantity of such additives or their
reaction products in foods, drugs, and cosmetics.
The net effect of the change would be to require the Secretary
to determine whether, with respect to particular color additives
and proposed listings, all of the analytical methods described both
in the original bill and in the proposed amendment are needed and,
to the extent that they are, to refuse a listing unless these methods
exist and are made available to him, whereas, under the bill as
originally introduced, the Secretary must refuse a listing unless
all of the described methods of analysis are available to him, with-
-------
STATUTES AND LEGISLATIVE, HISTORY 1127
out regard to whether, with respect to a particular proposed listing
of a color additive, such methods are in his judgment actually
needed.
The proponents of the amendment believe that some of the
requirements of the original bill, and in particular the require-
ment that there be practicable methods for determining the iden-
tity and quantity of any substance formed in or on food because
of the use of a color additive, could not always be met in the pres-
ent state of knowledge and that, in those cases in which there is no
need for such a method of analysis for adequate public health pro-
tection, the requirement would unnecessarily bar the use of a color
additive which would be perfectly safe. The committee amendment
meets this objection without impairing consumer health protection.
[p. 19]
Section 105
Contains appropriate changes of cross-references in, and other
conforming amendments to sections 301 (i) (false use of required
marks), 303 (c) (3) (guarantee that coal-tar color is certified), and
402 (d) (nonnutritive substances in confectionery) of the basic act.
[p. 29]
PENALTIES
SEC. 303. (a) Any person who violates any of the provisions of
section 301 shall be guilty of a misdemeanor and shall on convic-
tion thereof be subject to imprisonment for not more than one year,
or a fine of not more than $1,000, or both such imprisonment and
fine; but if the violation is committed after a conviction of such
person under this section has become final such person shall be
subject to imprisonment for not more than three years, or a fine
of not more than $10,000, or both such imprisonment and fine.
(b) Notwithstanding the provisions of subsection (a) of this
section, in case of a violation of any of the provisions of section
301, with intent to defraud or mislead, the penalty shall be impris-
onment for not more than three years, or a fine of not more than
$10,000, or both such imprisonment and fine.
(c) No person shall be subject to the penalties of subsection (a)
of this section, (1) for having received in interstate commerce any
article and delivered it or proffered delivery of it, if such delivery
or proffer was made in good faith, unless he refuses to furnish on
request of an officer or employee duly designated by the Secretary
the name and address of the person from whom he purchased or
received such article and copies of all documents, if any there be,
pertaining to the delivery of the article to him; or (2) for having
violated section 301 (a) or (d), if he establishes a guaranty or
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1128 LEGAL COMPILATION—PESTICIDES
undertaking signed by, and containing the name and address of,
the person residing in the United States from whom he received
in good faith the article, to the effect, in case of an alleged viola-
tion of section 301 (a), that such article is not adulterated or mis-
branded, within the meaning of this Act, designating this Act, or
to the effect, in case of an alleged violation of section 301 (d), that
such article is not an article which may not, under the provisions
of section 404 or 505, be introduced into interstate commerce; or
(3) for having violated section 301 (a), where the violation exists
because the article is adulterated by reason of containing a [coal-
tar] color additive not from a batch certified in accordance with
regulations promulgated by the Secretary under this Act, if such
person establishes a guaranty or undertaking signed by, and con-
taining the name and address of, the manufacturer of the [coal-
tar] color additive, to the effect that such color additive was from
a batch certified in accordance with the applicable regulations pro-
mulgated by the Secretary under this Act; or (4) for having vio-
lated section 301 (b), (c) or (k) by failure to comply with section
502 (f) in respect to an article received in interstate commerce to
which neither section 503 (a) nor section 503 (b) (1) is applicable,
if the delivery or proffered delivery was made in good faith and
the labeling at the time thereof contained the same directions for
use and warning statements as were contained in the labeling at
the time of such receipt of such article.
* [p. 86]
EXPLANATION OP PRINCIPAL FEATURES AND PURPOSES OP PROPOSED
COLOR ADDITIVE AMENDMENTS OF 1959
The letter of transmittal briefly summarizes the general objec-
tives of this legislative proposal, the principal reasons which gave
rise to it, and previous amendments to the Federal Food, Drug,
and Cosmetic Act which, in the case of Food, show congressional
endorsement of its key principle, that is, recognition of the scien-
tific soundness of considering the level and other conditions of use
in determining the safety of a color additive. A fuller explanation
is, however, necessary to an adequate understanding of the major
provisions of the bill and their purposes against the background
of existing law. In addition, a section-by-section analysis is
enclosed for the benefit of those who desire to become conversant
with the details of each provision.
A. PRESENT LAW
Under present law, the treatment of color additives differs radi-
cally as between the so-called coal-tar colors and others. (For
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STATUTES AND LEGISLATIVE HISTORY 1129
explanation of the technical difference between so-called coal-tar
colors and others, see the discussion under "Major Changes Pro-
posed.")
1. Coal-tar colors.—The act requires the Secretary to provide by
regulation for listing and certifying batches of "coal-tar colors
which are harmless and suitable for use" in food, drugs, or cos-
metics; and a food, drug, or cosmetic (other than a hair dye) is
deemed adulterated if it bears or contains a coal-tar color other
than from a certified batch (except that in the case of drugs this
provision applies only where the coal-tar color is used for coloring
[P.63]
purposes only). (See sees. 402(c), 406(b), 501 (a) (4), 504, 601
(e), 604, and 701 (e) and (f) of the act.) Under these provisions,
we are without power to admit a color to listing under tolerance
limitations. (Flemming v. Florida Citrus Exchange, 358 U.S.
153 (1958)).
2. Other colors.—A coloring material not classified as a coal-tar
color is not subject to any pretesting, listing, or certification
requirement in the case of cosmetics or drugs (except as pretesting
may be required for a coloring component as an incident to official
clearance of a "new drug" under the "new drug" provisions of
the act).
On the other hand, with respect to their use in food, non-coal-tar
coloring materials which are classed as "food additives" under the
recent Food Additives Amendment of 1958 (Public Law 85-929)
are subject to a requirement of official safety clearance, and to the
establishment of tolerance limitations and other conditions of safe
use where necessary for public health protection, except that colors
which were in commercial use before January 1, 1958, are allowed
a grace period for compliance; this period will expire not later than
March 6, 1961. Such "food additive" colors, however, are not sub-
ject to any requirement of "batch" certification even if, in our
view, this would be desirable for the protection of food processors
and housewives using the color.
B. MAJOR CHANGES PROPOSED
The bill would change existing law in the following respects:
1. Uniform criteria of admissibility.—It would do away with the
differences in legal requirements and treatment as between the
so-called coal-tar colors and other color additives, and would estab-
lish an integrated and internally consistent basis for determining
the admissibility of any coloring material for use in or on foods,
drugs, or cosmetics, other than hair dyes. This would be accom-
plished by excepting color additives, as defined in the bill, from the
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1130 LEGAL COMPILATION—PESTICIDES
term "food additive"; repealing the present provisions for listing
and certification of coal-tar colors; enacting, as part of a single
section (sec. 706), comprehensive provisions for the separate list-
ing of any color additives suitable and safe for general or
restricted use in foods, drugs, or cosmetics, and for their certifi-
cation (or exemption from certification) ; and making other
amendments to the act to mesh with these provisions.
The term "coal-tar color" has been interpreted to apply not only
to substances which are coal-tar derivatives, but also to synthetic
substances so related in their chemical structure to a coal-tar con-
stituent as to be capable of derivation therefrom even when not
actually so derived. The present bill would embrace all color addi-
tives whether or not synthesized and whether or not capable of
derivation from a coal-tar constituent. From the point of view of
determining safety of use, there is no sound scientific basis for
distinguishing between a color additive extracted from a plant,
animal, or mineral source and one which is synthesized with a
chemical structure which will bring it under the term "coal-tar
color." The bill would, therefore, establish common ground rules
for all such colors.
Doing away with the distinction between so-called coal-tar col-
ors and other coloring substances will have the incidental effect of
establishing a pretesting and safety clearance requirement for the
latter type of colors in the case of drugs or cosmetics. The lack of
consumer protection inherent in the absence of such a requirement
[P. 64]
was forcefully brought to the attention of Congress by the investi-
gations and recommendations of the House Select Committee to
Investigate the Use of Chemicals in Foods and Cosmetics, Delaney
committee—see House Report No. 2356, and House Report No.
2182, 82d Congress—and by the hearings culminating in the enact-
ment of the Food Additives Amendment of 1958.
2. Safety-of-use principle.—The bill adopts for all colors, and for
all color uses covered by it, the basic principle of the Food Addi-
tives Amendment of 1958, by providing for the official listing of
color additives for any use in or on foods, drugs, or cosmetics, for
which they are determined to be safe, subject to such conditions
of use, including maximum tolerance limitations, as are determined
to be necessary to assure the safety of such use.
3. Comprehensive lists.—The bill, however, retains the approach
of the present coal-tar color provisions in providing for compre-
hensive lists of colors, instead of attempting to carve out an excep-
tion from listing for colors "generally recognized" by experts as
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STATUTES AND LEGISLATIVE HISTORY 1131
safe for use. While there may have been justification in the case
of the Food Additives Amendment of 1958 for placing the burden
on the Government to prove that an additive is not generally recog-
nized as safe before the safety clearance procedure applies — in
view of the broad sweep of the amendment, which otherwise would
have covered such additives as salt, vinegar, and natural spices—
we do not believe that such an exception is sound in the case of
color additives, whether they be extracted from a natural source
or synthesized. To engraft such an exception on the bill would be
retrogressive as compared with present law relating to coal-tar
colors. If a color is in fact generally recognized by competent
experts as safe for unrestricted use in any kind of article, this can
be readily established and reflected in regulations listing such color.
4. Certification and exemptions from certification.—While pro-
viding for certification of batches of listed colors, as existing law
does for coal-tar colors, the bill would permit the Secretary to grant
exemptions from the requirement of certification where certifica-
tion is not necessary to protect the public health. The present
requirement of certification for coal-tar colors is intended to assure
food processors and housewives that the color is free from toxic
impurities and otherwise complies with regulations defining the
color's identity. We believe, however, that power to exempt colors
from the certification requirement is desirable, especially since the
coverage of the law is broadened to include all types of substances
capable of imparting color.
5. Effective date and transitional provisions.—The amendments
made by the bill to the Federal Food, Drug, and Cosmetic Act, that
is, title I of the bill, would become effective as soon as the bill is
enacted.
However, in order to allow on an interim basis, for a reasonable
period, the use of commercially established color additives to the
extent consistent with the public health, pending completion of the
scientific investigations needed as a basis for making determina-
tions as to listing of such additives under the new permanent pro-
visions of the bill, the bill provides for the provisional listing of
such color additives, and their certification (or exemption from
certification in certain cases). The "commercially established"
color additives falling under these transitional provisions are (a)
those coal-tar colors of which a batch or batches were actually cer-
[p.65]
tiffed prior to the date of enactment of the bill, and (b) those non-
coal-tar colors, and synthetic beta-carotene, which were commer-
cially used or sold prior to that date for food, drug, or cosmetic use.
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1132 LEGAL COMPILATION—PESTICIDES
Provisional listings would be subject to appropriate temporary
tolerance limitations and other conditions of use when deemed nec-
essary for the protection of the public health during the period of
provisional listing. The bill would permit establishment of a zero
tolerance or removal from the provisional list at any time during
this transitional period when the protection of the public health
so requires.
A provisional listing would be automatic, except that in the case
of a coal-tar color which was "delisted" prior to the enactment date
of the bill, the color could be provisionally listed under these tran-
sitional provisions only upon request to the Secretary.
In order to enable the Secretary to compile and promulgate a
list of colors which are deemed provisionally listed without specific
request to the Secretary, and in order to enable him to determine
temporary tolerances for such colors, the Secretary would, after
reasonable public notice for submission of data, be required, for
the time being, to fix temporary tolerances at zero level with
respect to those colors and uses thereof for which the data avail-
able to him do not establish a reliable basis for inclusion in a list
of colors deemed provisionally listed and for determining the pre-
vailing levels of use thereof prior to the enactment date.
In general, a provisional listing would terminate no later than
the end of the 2^-year period beginning on the date of enactment.
However, where necessary to complete the scientific testing
required for a particular additive, the Secretary could extend this
period with respect to a particular color additive or use, if this is
consistent with the protection of the public health and with the
objective of completing these tests as soon as practicable. Of
course, a provisional listing of a color additive for any use, if not
sooner terminated, would cease upon listing of the additive for such
use under the permanent provisions of the bill.
C. NEED FOR THE BILL
The interests of consumer protection and of the food, drug, cos-
metic ; and color industries combine to make urgent the need for
enactment of this bill.
1. Consumer protection
First. — Under present law the Government has to perform
extensive research to determine whether the colors now listed and
being used are in fact harmless and suitable for use in food, drugs,
and cosmetics. This testing may require up to 20 years. The bill
would require industry to assume the burden of this testing, and
would require the tests to be completed within 2Va years or, in
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STATUTES AND LEGISLATIVE HISTORY 1133
individual cases, such additional testing period as is shown to be
required and to be consistent with public-health protection. Fur-
ther, it would allow the Department to place safe tolerance limi-
tations on the amount of color that may be used and the products
on which it may be used during this transition period; the Depart-
ment has no such authority under present law.
[p.66]
1.13e (3) CONGRESSIONAL RECORD
1.13e (3) (a) VOL. 105 (1959), Aug. 24: Amended and passed
Senate, p. 16778
[No Relevant Discussion on Pertinent Section]
1.13e (3) (b) VOL. 106 (1960), June 25: Amended and passed
House, pp. 14373,14377
[No Relevant Discussion on Pertinent Section]
1.13e (3) (c) VOL. 106 (1960), June 30: Senate concurs in House
amendments, p. 15135
[No Relevant Discussion on Pertinent Section]
1.13f DRUG ABUSE CONTROL AMENDMENTS OF 1965
July 15,1965, P.L. 89-74, §§7, 9(d), 79 Stat. 233, 235
PENALTIES
SEC. 7 (a) Section 303 (a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 333 (a) ) is amended by inserting after the
final word "fine" and before the period the following: " '.Provided,
however, That any person who, having attained his eighteenth
birthday, violates section 301 (q) (2) by selling, delivering, or oth-
erwise disposing of any depressant or stimulant drug to a person
who has not attained his twenty-first birthday shall, if there be no
previous conviction of such person under this section which has
become final, be subject to imprisonment for not more than two
years, or a fine of not more than $5,000, or both such imprisonment
and fine, and for the second or any subsequent conviction for such
a violation shall be subject to imprisonment for not more than six
years, or a fine of not more than $15,000, or both such imprison-
ment and fine".
(b) Section 303 (b) of such Act (21 U.S.C. 333 (b)) is amended
by inserting after the word "shall" the following: "(except in the
case of an offense which is subject to the provisions of the proviso
to subsection (a) relating to second or subsequent offenses)".
[p. 233]
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1134 LEGAL COMPILATION—PESTICIDES
SEC. 9.
* * *****
(d) Section 303 of such Act (21 U.S.C. 333 (c) ) is amended by
inserting immediately before the period at the end thereof the
following: "; or (5) for having violated section 301 (i) (2) if such
person acted in good faith and had no reason to believe that use of
the punch, die, plate, stone, or other thing involved would result
in a drug being a counterfeit drug, or for having violated section
301 (i) (3) if the person doing the act or causing it to be done
acted in good faith and had no reason to believe that the drug was
a counterfeit drug".
[p. 235]
1.13f (1) HOUSE COMMITTEE ON INTERSTATE AND FOR-
EIGN COMMERCE
H.R. REP. No. 130, 89th Cong., 1st Sess. (1965)
DRUG ABUSE CONTROL AMENDMENTS OF 1965
MARCH 2,1965.—Committed to the Committee of the Whole House on the State
of the Union and ordered to be printed
Mr. HARRIS, from the Committee on Interstate and Foreign
Commerce, submitted the following
REPORT
[To accompany H.R. 2]
The Committee on Interstate and Foreign Commerce, to whom
was referred the bill (H.R. 2) to protect the public health and
safety by amending the Federal Food, Drug, and Cosmetic Act to
establish special controls for depressant and stimulant drugs, and
for other purposes, having considered the same, report favorably
thereon with amendments and recommend that the bill as amended
do pass.
The amendments are a substitute for the text of the bill which
is printed in italic type in the bill, as reported, and an amendment
to the title which conforms it to the substitute amendment.
PURPOSE OF THE BILL
The bill provides increased controls over the distribution of bar-
biturates, amphetamines, and other drugs having a similar effect
on the central nervous system. The controls are accomplished
through increased recordkeeping and inspection requirements,
through providing for control over intrastate traffic in these drugs
-------
STATUTES AND LEGISLATIVE HISTORY 1135
because of its effect on interstate traffic, and through making pos-
session of these drugs (other than by the user) illegal outside of
the legitimate channels of commerce. The bill also increases the
authority of the Department of Health, Education, and Welfare
over counterfeit drugs.
tp-1]
SECTION 7. PENALTIES
This section amends section 303 of the Federal Food, Drug, and
Cosmetic Act so as to provide a special penalty in any case where a
person who is 18 years of age or older is convicted of selling, deliver-
ing, or otherwise disposing of any depressant or stimulant drug
to any person who is younger than 18 years of age. In the case of
a first offense the penalty would be imprisonment for not more
than 2 years, or a fine of not more than $5,000, or both, and, in the
case of a second or subsequent offense, imprisonment for not more
than 6 years, or a fine of not more than $15,000, or both.
[p.19]
SECTION 9. COUNTERFEITING OF DRUGS
(1) there is a substantial traffic in counterfeit drugs;
(2) such traffic poses a serious hazard to the health of
innocent consumers of such drugs because of the lack of pro-
per qualifications, facilities, and manufacturing controls on
the part of the counterfeiters;
(3) the controls for the suppression of the traffic in coun-
terfeit drugs are inadequate; and
(4) these factors require enactment of additional controls
with respect to counterfeit drugs without regard to their
interstate or intrastate origins.
Subsection (b) adds to section 201 of the Federal Food, Drug,
and Cosmetic Act a definition of "counterfeit drug." As defined,
the term means a drug which, or the container or labeling of
which, without authorization, bears the trademark, trade name,
or other identifying mark, imprint, or device, or any likeness
thereof of a drug manufacturer, processor, packer, or distributor
other than the person or persons who in fact manufactured, proc-
essed, packed, or distributed such drug and which thereby falsely
purports or is represented to be the product of, or to have been
packed or distributed by, such other drug manufacturer, processor,
packer, or distributor.
Subsection (c) amends section 301 of the Federal Food, Drug,
and Cosmetic Act so as to add to the list of things prohibited by
that section the (1) making, selling, disposing of, or keeping in
possession, control, or custody, or concealing anything designed
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1136 LEGAL COMPILATION—PESTICIDES
to reproduce the identifying mark of another or any likeness there-
of upon any drug or container or labeling thereof so as to render
such drug a counterfeit drug, or (2) the doing of any act which
causes a drug to be a counterfeit drug, or the sale or dispensing,
or the holding for sale or dispensing, of a counterfeit drug.
Subsection (d) amends section 303 of the Federal Food, Drug,
and Cosmetic Act so as to provide that no person shall be subject
to a penalty for having done any act described in clause (1) of
the preceding paragraph if he acted in good faith and had no
reason to believe that use of any such thing would result in a drug
being a counterfeit drug, or for having done any act described
in clause (2) of the preceding paragraph if he acted in good faith
and had no reason to believe that the drug was a counterfeit drug.
[p. 20]
1.13f (2) SENATE COMMITTEE ON LABOR AND PUBLIC
WELFARE
S. REP. No. 337, 89th Cong., 1st Sess. (1965)
DRUG ABUSE CONTROL AMENDMENTS OF 1965
JUNE 21,1965.—Ordered to be printed
Mr. YARBOROUGH, from the Committee on Labor and Public Wel-
fare, submitted the following
REPORT
[To accompany H.R. 2]
The Committee on Labor and Public Welfare, to whom was
referred the bill (H.R. 2) to protect the public health and safety
by amending the Federal Food, Drug, and Cosmetic Act to estab-
lish special controls for depressant and stimulant drugs and coun-
terfeit drugs, and for other purposes, having considered the same,
report favorably thereon with amendments and recommend that
the bill as amended do pass.
PURPOSE
The bill provides increased controls over the distribution of
barbiturates, amphetamines, and other drugs having a similar
effect on the central nervous system. The controls are accom-
plished through increased recordkeeping and inspection require-
ments, through providing for control over intrastate traffic in
these drugs because of its effect on interstate traffic, and through
making possession of these drugs (other than by the user) illegal
-------
STATUTES AND LEGISLATIVE HISTORY 1137
outside of the legitimate channels of commerce. The bill also
increases the authority of the Department of Health, Education,
and Welfare over counterfeit drugs.
A bill with the same objectives in the control of stimulant and
depressant drugs was sponsored by Senator Dodd and unanimously
approved by the Senate last year. That bill was S. 2628.
[p.l]
Section 7 provides for increased maximum penalties for persons
over 18 who illegally dispense a depressant or stimulant drug to
persons under 21, i.e., up to 2 years or $5,000 or both for the first
offense, and 6 years or $15,000 or both for a subsequent offense, as
compared to the maximum of 1 year and $1,000 for a first offense
(not shown to involve an intent to defraud or mislead) and 3 years
and $10,000 for a subsequent offense (or for first offenses com-
mitted with intent to defraud or mislead) otherwise applicable
under the Food, Drug, and Cosmetic Act.
*******
Section 9 (a) contains a finding that there is a substantial traffic
in counterfeit drugs, that such traffic poses a serious health haz-
ard, that, while such drugs are misbranded under section 502 (i)
of the Food, Drug, and Cosmetic Act, controls for suppression of
the traffic are inadequate because of the difficulty of determining
the place of origin and the fact that implements for counterfeiting
are not subject to seizure, and that these factors require enact-
ment of additional controls as to such drugs without regard to their
interstate or intrastate origin.
Section 9 (b) defines the term "counterfeit drug" to mean "a
drug which, or the container or labeling of which, without author-
ization, bears the trademark, trade name, or other identifying
mark, imprint, or device, or any likeness thereof, of a drug manu-
facturer, processor, packer, or distributor, other than the person
or persons who, in fact, manufactured, processed, packed, or
distributed such drug and which thereby falsely purports or is
represented to be the product of, or to have been packed or dis-
tributed by, such other drug manufacturer, processor, packer, or
distributor."
Section 9 (c) prohibits the making, selling, disposing of, pos-
sessing, or concealing of equipment for counterfeiting drugs. It
also prohibits the doing of any act which causes a drug to be a
counterfeit drug, or the sale or dispensing, or the holding for sale
or dispensing, of a counterfeit drug. Persons acting in good faith
and having no reason to believe that their acts, or the use of the
equipment, would result in a counterfeit drug, or that the drugs
-------
1138 LEGAL COMPILATION—PESTICIDES
in their possession are counterfeits, are exempted from the crimi-
nal penalties of the statute because of acts prohibited by section
9
-------
STATUTES AND LEGISLATIVE HISTORY 1139
"(3) (A) Except as otherwise'provided in this subparagraph
or in subparagraph (B), any person who violates clause (3) (B)
of section 301 (q) shall be imprisoned for not more than one year
or fined not more than $1,000, or both. If any person commits
such a violation after two prior convictions of him for violation
of such clause have become final, he shall be imprisoned for not
more than three years or fined not more than $10,000, or both.
"(B) In the case of any person who is convicted for the first
time of violating a provision of section 301 (q) and whose con-
viction was for violating clause (3) (B) of such section, the court
may suspend the imposition or execution of sentence and place
such person on probation subject to such conditions as the court
may impose and for such period, not to exceed one year, as the
court may prescribe. The court may, in its discretion, uncondi-
tionally discharge such person from probation prior to the expi-
ration of the maximum period prescribed for such person's pro-
bation. Such discharge shall automatically set aside the convic-
tion, and the court shall issue to such person a certificate to that
effect. If during the period of his probation such person does not
violate any of the conditions of his probation, his conviction shall
at the expiration of such period be automatically set aside, and
the court shall issue to such person a certificate to that effect."
[p.1362]
1.13g (1) HOUSE COMMITTEE ON INTERSTATE AND FOR-
EIGN COMMERCE
H.R. REP. No. 1546, 90th Cong., 2d Sess. (1968)
INCREASING PENALTIES FOR UNLAWFUL ACTS
INVOLVING LSD AND OTHER DEPRESSANT AND
STIMULANT DRUGS
JUNE 12,1968.—Committed to the Committee of the Whole House on the State
of the Union and ordered to be printed
Mr. STAGGERS, from the Committee on Interstate and Foreign
Commerce, submitted the following
REPORT
[To accompany H.R. 14096]
The Committee on Interstate and Foreign Commerce, to whom
was referred the bill (H.R. 14096) to amend the Federal Food,
Drug, and Cosmetic Act to prescribe penalties for the possession
of LSD and other hallucinogenic drugs by unauthorized persons,
-------
1140 LEGAL COMPILATION—PESTICIDES
having considered the same, report favorably thereon with
amendments and recommend that the bill as amended do pass.
The amendments are as follows:
Strike out all after the enacting clause and insert in lieu there-
of the following:
That section 201 (v) (3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321) is amended by striking out "any drug" and inserting in lieu
thereof "lysergic acid diethylamide and any other drug".
SEC. 2. (a) Section 511 (c) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360a (c)) is amended to read as follows:
"(c) No person, other than a person described in subsection (a) or (b) (2)
of this section, shall—
"(1) possess any depressant or stimulant drug for sale, delivery, or
other disposal to another, or
"(2) otherwise possess any such drug unless such drug was obtained
directly, or pursuant to a valid prescription, from a practitioner (licensed
by law to prescribe or administer such a drug) while acting in the course
of his professional practice."
(b) Clause (3) of paragraph (q) of section 301 of such Act (21 U.S.C. 331
(q) (3) is amended to read as follows: "(3) (A) the possession of a drug in
violation of section 511 (c) (1), or (B) the possession of a drug in violation of
section 511 (c) (2);".
SEC. 3. Section 303 of such Act (21 U.S.C. 333) is amended by striking out
subsections (a) and (b) inserting in lieu thereof the following new sub-
sections :
[P.I]
"SEC. 303. (a) Any person who violates a provision of section 301 (other
than a provision referred to in subsection (b) of this section) shall be impris-
oned for not more than one year or fined not more than $1,000, or both; except
that if any person commits such a violation after a conviction of him under
this subsection has become final, or commits such a violation with the intent to
defraud or mislead, such person shall be imprisoned for not more than three
years or fined not more than $10,000, or both.
"(b) (1) Any person who violates clause (1), (2), or (3) (A) of section
301 (q), or violates, with respect to a depressant or stimulant drug, any of the
provisions of paragraph (3) of section 301 (i), shall, except as otherwise
provided in paragraph (2) of this subsection, be imprisoned for not more than
five years or fined not more than $10,000, or both.
"(2) Any person eighteen or older who violates clause (2) of section 301
(q) by selling, delivering, or otherwise disposing of any depressant or stimu-
lant drug to a person who is under twenty-one, shall be imprisoned for not
more than ten years or fined not more than $15,000, or both, except that if any
person commits such a violation after a conviction of him under this paragraph
has become final, he shall be imprisoned for not more than fifteen years or
fined not more than $20,000, or both.
"(3) (A) Except as provided in subparagraph (B) of this paragraph, any
person who violates clause (3) (B) of section 301 (q) shall (1) be imprisoned
for not more than one year or fined not more than $1,000, or both, if he has
not been convicted of violating any provision of section 301 (q) prior to his
conviction for violating such clause, or (2) be imprisoned for not more than
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STATUTES AND LEGISLATIVE HISTORY 1141
three years or fined not more than $10,000, or both, if he has been convicted of
violating a provision of such section prior to his conviction for violating such
clause.
"(B) In the case of any person who is convicted for the first time of
violating a provision of section 301 (q) and whose conviction was for violating
clause (3) (B) of such section, the court may suspend the imposition or
execution of sentence and place such person on probation subject to such con-
ditions as the court may impose and for such period, not to exceed one year,
as the court may prescribe. The court may, in its discretion, unconditionally
discharge such person from probation prior to the expiration of the maximum
period prescribed for such person's probation. Such discharge shall automati-
cally set aside the conviction, and the court shall issue to such person a certifi-
cate to that effect. If during the period of his probation such person does not
violate any of the conditions of his probation, his conviction shall at the
expiration of such period be automatically set aside, and the court shall issue
to such person a certificate to that effect."
SEC. 4. It is the sense of the Congress that, because of the inadequate knowl-
edge on the part of the people of the United States of the substantial adverse
effects of misuse of depressant and stimulant drugs, and of other drugs liable
to abuse, on the individual, his family, and the community, his highest priority
should be given to Federal programs to disseminate information which may be
used to educate the public, particularly young persons, regarding the dangers
of drug abuse.
SEC. 5. The amendments made by this Act shall apply only with respect
to violations of the Federal Food, Drug, and Cosmetic Act committed after the
date of the enactment of this Act.
Amend the title so as to read:
A bill to amend the Federal Food, Drug, and Cosmetic Act to increase the
penalties for unlawful acts involving lysergic acid diethylamide (LSD) and
other depressant and stimulant drugs, and for other purposes.
PRINCIPAL PURPOSE OF THE BILL
As reported by the committee, the bill would provide increased
penalties for persons trafficking illegally in barbiturates, depres-
sants, amphetamines, and LSD, and other halucinogens, and
would make possession of barbiturates, depressants, ampheta-
mines and hallucinogenic drugs a misdemeanor, unless the drugs
in question were obtained pursuant to a valid prescription. Provi-
sion is made for special treatment of first offenders accused of
illegal possession of the drugs in question.
[p. 2]
Since the provisions of the bill with respect to penalties for pos-
session are intended primarily as an aid to law enforcement agen-
cies, and the other provisions provide increased penalties for acts
already made illegal, it is not anticipated that any increased appro-
priations would be required to carry out the act.
[p. 3]
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1142 LEGAL COMPILATION—PESTICIDES
PENALTIES FOR POSSESSION
In the 1965 Drug Abuse Control Amendments, possession of
dangerous drugs for personal use was not made a prohibited act,
although possession for purposes of sale or other disposition to
another outside of legitimate channels of trade was made a pro-
hibited act, subject to fine and imprisonment.
Testimony presented at the hearings indicated that a number
of physicians feel that possession for personal use should be con-
trolled through educational programs, and not through making
such possession a criminal offense. This feeling appears to be
based generally upon the theory that the adverse effects, particu-
larly on the young, of arrest and prosecution, with the possibility
of consequent criminal records, overweigh the adverse effects of
drug abuse.
This approach, of course, involves subjective judgments, balanc-
ing adverse physical and psychological effects of drug abuse
against the psychological effects of fear of arrest, and possible
arrest and prosecution. The view that possession should not be
a prohibited act is not however a view unanimously held by the
medical profession. The committee received testimony from phy-
sicians in support of the approach of the bill. [p. 6]
In general, law enforcement officers favor making possession
of drugs illegally obtained a prohibited act. Not only does the
presence of such a penalty in the law operate as a deterrent, penal-
ties for possession serve greatly to aid in law enforcement. It is
frequently difficult to obtain evidence sufficient to sustain a suc-
cessful prosecution against a person trafficking in drugs; how-
ever, where the possession of such drugs is illegal, arrests and
prosecution for possession can serve to take these traffickers out
of circulation and thereby curtail illicit traffic in these drugs.
A further reason for making the possession of dangerous drugs
obtained illictly a prohibited act is to counter the feeling among
some young people that abuse of dangerous drugs is not detri-
mental to them, since there is no penalty for personal abuse.
APPROACH OF THE BILL
The committee has attempted to strike a balance between the
conflicting points of view on the question of whether or not pos-
session of dangerous drugs obtained illicitly should be made a
prohibited act, subject to fine or imprisonment. The bill makes
possession of dangerous drugs a misdemeanor subject to imprison-
ment up to 1 year and a fine up to $1,000 for a first offender, with
a penalty of up to 3 years' imprisonment and up to $10,000 fine
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STATUTES AND LEGISLATIVE HISTORY 1143
for the second and subsequent offenses. The bill also provides,
however, that where an individual is charged with simple posses-
sion of dangerous drugs obtained without a doctor's prescription,
and he has not previously been convicted of a violation of the law
with respect to dangerous drugs, the court may, in lieu of fine or
imprisonment, place the offender upon probation for such period,
up to 1 year, as the court might determine, subject to such condi-
tions as the court may impose. For example, a person charged
with the first offense of possession could be required to obtain
psychiatric help as a condition of probation. The court is author-
ized to discharge the offender from probation prior to the expira-
tion of 1 year. If the offender is discharged from probation by
the court, or if, at the completion of the period of probation
prescribed by the court, the court determines that the offender has
fully complied with the terms and conditions of probation, the con-
viction is automatically set aside and the court is required to issue
a certificate to the offender to this effect.
In this fashion, persons convicted of a first offense for personal
use may, in the discretion of the court, be treated with leniency,
and upon compliance with the conditions of probation, wind up
with no criminal record. In the event of a second offense against
the laws controlling dangerous drugs by a person whose conviction
has been set aside under the previous procedure, that individual
will be treated as a first offender (see Stevenson, v. U.S. 380 F2d
590, 593 (D.C. Cir. 1967) ; however, in the case of the second
offense the court will have available to it as a part of normal
presentence investigations, knowledge of the previous set-aside
conviction, and the court will take this fact into account in deter-
mining whether or not to grant probation to the offender.
Of course, if the offender is a juvenile (below the age of 18),
the Juvenile Offenders Act will apply to him, which means that
[p. 7]
he will be treated in the same fashion as other juvenile offenders
against Federal law are treated; and as an adult will have no crim-
inal record. In addition, in the case of a youthful offender (below
the age of 26), the Federal Youth Offenders Act will also be appli-
cable, which also provides for probation, and under some circum-
stances, the setting aside of a conviction.
In addition to the above protections for youthful offenders, the
Department of Justice has established administratively a system
referred to as the Brooklyn Plan, under which the U.S. attorney,
may, either prior to or after arrest, call the juvenile offenders
and parents or guardian where appropriate to his office, and with-
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1144 LEGAL COMPILATION—PESTICIDES
hold arrest or prosecution of the offender in appropriate cases
where, in the discretion of the U.S. attorney, it appears that the
purposes of the law can be better served thereby.
The committee has therefore struck a balance in the reported
bill between the separate points of view concerning penalties for
possession of dangerous drugs. The committee has prescribed
penalties for possession, both as an aid to law enforcement and for
its deterrent effect; however, the committee has added to the pro-
tection of the Brooklyn Plan, the Juvenile Offenders Act, and the
Federal Youth Corrections Act further protections designed to
minimize the long term adverse consequences upon a youth of a
conviction of a violation of the prohibition against possession of
dangerous drugs.
In his message on the Challenge of Crime to Our Society of
February 7,1968 (H. Doc. 250, 90th Cong.) the President request-
ed that the Congress enact legislation to make the illegal manu-
facture, sale, or distribution of LSD and other dangerous drugs
a felony and the illegal possession of these drugs a misdemeanor.
This bill carries out that recommendation.
Until April of this year, enforcement of this act was the re-
sponsibility of the Food and Drug Administration, acting through
the Bureau of Drug Abuse Control. Reorganization Plan No. 1
of 1968 establishing the Bureau of Narcotics and Dangerous
Drugs, transferred to the Attorney General all functions of the
Secretary of Health, Education, and Welfare under this act except
the function of regulating the counterfeiting of drugs which are
not controlled depressant or stimulant drugs.
INCREASED PENALTIES FOE TRAFFICKING IN DANGEROUS DRUGS
Under existing law (sec. 301 of the Federal Food, Drug, and
Cosmetic Act), the following are prohibited acts:
(1) Manufacture, compounding, or processing of a con-
trolled barbiturate, depressant, amphetamine, or hallucino-
gen outside legitimate channels of trade;
(2) Sale, delivery, or other disposition of such a drug
outside legitimate channels of trade; and
(3) Possession of such dangerous drug except where
obtained through legitimate channels, and except for per-
sonal use by the possessor or a member of his household or
for administration to an animal owned by him or a member
of his household.
Violation of any of the above provisions is subject to the same
penalties as are prescribed for other violations of the Food and
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STATUTES AND LEGISLATIVE HISTORY 1145
Drug Act; namely up to 1 year imprisonment or $1,000 fine, or
both, for a first offense and up to 3 years imprisonment or up to
[p. 8]
$10,000 fine, or both, for a second or subsequent offense, or for
a first offense committed with intent to defraud or mislead. High-
er penalties are prescribed for illegal sales of controlled drugs
to minors.
The reported bill follows the recommendations of the adminis-
tration, and makes all offenses involving illegal trafficking in con-
trolled barbiturates, amphetamines, or hallucinogens a felony, sub-
ject to imprisonment of up to 5 years, or a fine of up to $10,000, or
both. In case of a sale to a minor by a person over the age of 18, the
penalties prescribed in the bill are up to 10 years imprisonment
for a first offense or a fine of not more than $15,000, or both, and
in case of a second or subsequent offense, imprisonment for more
than 15 years or a fine of not more than $20,000, or both.
SECTION-BY-SECTION SUMMARY OP THE COMMITTEE AMENDMENT
*******
[p. 9]
Revision of penalties for offenses involving depressant or stimulant
drugs
Section 3 of the committee amendment makes a general revision
in the penalties prescribed in section 303 of the act for offenses
involving depressant or stimulant drugs. Examples of such offenses
are the unlawful manufacturing, sale, and possession of those
drugs, and failure to comply with recordkeeping, plant inspection,
and prescription requirements.
The penalties under existing law are as follows:
(1) A first offense involving a depressant or stimulant drug
committed without the intent to defraud or mislead is a misde-
meanor punishable by a fine not exceeding $1,000 or imprison-
ment for not more than a year, or both.
(2) A second or subsequent offense or one committed with the
intent to defraud or mislead is a felony punishable by a fine not
exceeding $10,000 or imprisonment for not more than 3 years,
or both.
(3) There is an exception to the provisions described in the
preceding paragraphs. If a person 18 or over sells or otherwise
unlawfully disposes of a depressant or stimulant drug to a person
under 21, the penalty for the first offense is a fine not exceeding
$5,000 or imprisonment for not more than 2 years, or both, but if
the offense is committed with the intent to defraud or mislead,
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1146 LEGAL COMPILATION—PESTICIDES
the penalty would be the one described in paragraph (2). The
penalty for second or subsequent offenses is a fine not exceeding
$15,000 or imprisonment for not more than 6 years, or both.
The committee amendment makes the following changes:
(1) In general, if the offense involves the unlawful manufac-
turing of, sale or other disposal of, or possession with intent to
sell, a depressant or stimulant drug or involves counterfeit depres-
sant or stimulant drugs, the penalty (prescribed in the new sec.
303 (b) (1) of the act) is a fine not exceeding $10,000 or impris-
onment for not more than 5 years, or both.
(2) A stiffer penalty is provided in the new section 303 (b)
(2) of the act for unlawful sales or other disposals of depressant
or stimulant drugs by persons over 18 to persons under 21. The
penalty for the first offense is a fine not exceeding $15,000 or
imprisonment for not more than 10 years, or both. The penalty
provision for second or subsequent offenses increases the maxi-
mum fine to $20,000 and the maximum imprisonment to 15 years.
(3) The penalty provision in the new section 303 (b) (3) for
possession of a depressant or stimulant drug for purposes other
than sale or other disposal contains a special provision for a person
whose conviction for such possession is his first conviction for
any offense under the act. The court may suspend the imposition
or execution of sentence on that person and place him on proba-
tion for not to exceed 1 year. If the court unconditionally dis-
charges that person from probation prior to the prescribed
probation period or if he completes his probation period without
violating any of the conditions of his probation, the conviction
of that person is automatically set aside. This provision is similar
to provisions in the Federal Youth Corrections Act (18 U.S.C.
5005-5026). [p. 10]
CHANGES IN EXISTING LAW MADE BY THE BILL, AS
REPORTED
In compliance with clause 3 of rule XIII of the Rules of the
House of Representatives, changes in existing law made by the
bill, as reported, are shown as follows (existing law proposed to be
omitted is enclosed in black brackets, new matter is printed in
italic, existing law in which no change is proposed is shown in
roman):
*******
[p. 12]
PENALTIES
[SEC. 303 (a) Any person who violates any of the provisions of
section 301 shall be guilty of a misdemeanor and shall on convic-
-------
STATUTES AND LEGISLATIVE HISTORY 1147
tion thereof be subject to imprisonment for not more than one
year, or a fine of not more than $1,000, or both such imprisonment
and fine; but if the violation is committed after a conviction of such
person under this section has become final such person shall be
subject to imprisonment for not more than three years, or a fine
of not more than $10,000, or both such imprisonment and fine:
Provided, however, That any person who, having attained his
eighteenth birthday, violates section 301 (q) (2) by selling, deliver-
ing, or otherwise disposing of any depressant or stimulant drug to
a person who has not attained his twenty-first birthday shall, if
there be no previous conviction of such person under this section
which has become final, be subject to imprisonment for not more
than two years, or a fine of not more than $5,000, or both such
imprisonment and fine, and for the second or any subsequent con-
viction for such a violation shall be subject to imprisonment for
not more than six years, or a fine of not more than $15,000, or
both such imprisonment and fine.
[ (b) Notwithstanding the provisions of subsection (a) of this
section, in case of a violation of any of the provisions of section
301, with intent to defraud or mislead, the penalty shall (except in
the case of an offense which is subject to the provisions of the
proviso to subsection (a) relating to second or subsequent
offenses) be imprisonment for not more than three years, or a
fine of not more than $10,000, or both such imprisonment and fine.]
[p. 14]
Sec. 303. (a,) Any person who violates a provision of section 301
(other than a provision referred to in subsection (b) of this sec-
tion) shall be imprisoned for not more than one year or fined not
more than $1,000, or both; except that if any person commits such
a violation after a conviction of him under this subsection has
become final, or commits such a violation with the intent to defraud
or mislead, such person shall be imprisoned for not more than
three years or fined not more than $10,000, or both.
(b)(l) Any person who violates clause (1), (2), or (3)(A) of
section 301 (q), or violates, with respect to a depressant or stimu-
lant drug, any of the provisions of paragraph (3) of section 301 (i),
shall, except as otherwise provided in paragraph (2) of this sub-
section, be imprisoned for not more than five years or fined not
more than $10,000, or both.
(2) Any person eighteen or older who violates clause (2) of
section 301 (q) by selling, delivering, or otherwise disposing of
any depressant or stimulant drug to a person who is under twen-
ty-one, shall be imprisoned for not more than ten years or fined
-------
1148 LEGAL COMPILATION—PESTICIDES
not more than $15,000, or both, except that if any person commits
such a violation after a conviction of him, under this paragraph
has become final, he shall be imprisoned for not more than fifteen
years or fined not more than $20,000, or both.
(3) (A) Except as provided in subparagraph (B) of this para-
graph, any person who violates clause (3) (B) of section 301 (q)
shall (1) be imprisoned for not more than one year or fined not
more than $1,000, or both, if he has not been convicted of violating
any provision of section 301 (q) prior to his conviction for vio-
lating such clause, or (2) be imprisoned for not more than three
years or fined not more than $10,000, or both, if he has been con-
victed of violating a provision of such section prior to his convic-
tion for violating such clause.
(B) In the case of any person who is convicted for the first time
of violating a provision of section 301 (q) and whose conviction
was for violating clause (3) (B) of such section, the court may
suspend the imposition or execution of sentence and place such
person on probation subject to such conditions as the court may
impose and for such period, not to exceed one year, as the court
may prescribe. The court may, in its discretion, unconditionally
discharge such person from probation prior to the expiration of
the maximum period prescribed for such person's probation. Such
discharge shall automatically set aside the conviction, and the
court shall issue to such person a certificate to that effect. If dur-
ing the period of his probation such person does not violate any of
the conditions of his probation, his conviction shall at the expira-
tion of such period be automatically set aside, and the court shall
issue to such person a certificate to that effect.
(c) No person shall be subject to the penalties of subsection
(a) of this section, (1) for having received in interstate com-
merce any article and delivered it or proffered delivery of it, if
such delivery or proffer was made in good faith, unless he refuses
to furnish on request of an officer or employee duly designated by
the Secretary the name and address of the person from whom he
purchased or received such article and copies of all documents,
if any there be, pertaining to the delivery of the article to him;
or (2) for having violated section 301 (a) or (d), if he establishes
a guaranty or undertaking signed by, and containing the name
and address of, the person residing in the United States from
whom he received in good faith the article, to the effect, in case
[p. 15]
of an alleged violation of section 301 (a), that such article is not
adulterated or misbranded, within the meaning of this Act,
-------
STATUTES AND LEGISLATIVE HISTORY 1149
designating this Act, or to the effect, in case of an alleged viola-
tion of section 301 (d) that such article is not an article which
may not, under the provisions of section 404 or 505, be introduced
into interstate commerce; or (3) for having violated section 301
(a), where the violation exists because the article is adulterated
by reason of containing a color additive not from a batch certified
in accordance with regulations promulgated by the Secretary
under this Act, if such person establishes a guaranty or under-
taking signed by, and containing the name and address of, the
manufacturer of the color additive, to the effect that such color
additive was from a batch certified in accordance with the appli-
cable regulations promulgated by the Secretary under this Act; or
(4) for having violated section 301 (b), (c), or (k) by failure
to comply with section 502 (f) in respect to an article received
in interstate commerce to which neither section 503 (a) nor sec-
tion 503 (b) (1) is applicable, if the delivery or proffered deliv-
ery was made in good faith and the labeling at the time thereof
contained the same directions for use and warning statements
as were contained in the labeling at the time of such receipt of
article; or (5) for having violated section 301 (i) (2) if
such person acted in good faith and had no reason to believe that
use of the punch, die, plate, stone, or other thing involved would
result in a drug being a counterfeit drug, or for having violated
section 301 (i) (3) if the person doing the act or causing it to be
done acted in good faith and had no reason to believe that the drug
was a counterfeit drug.
*******
[p. 16]
1.13g (2) SENATE COMMITTEE ON LABOR AND PUBLIC
WELFARE
S. REP. No. 1609,90th Cong., 2d Seas. (1968)
AMENDMENTS TO THE FEDERAL FOOD, DRUG,
AND COSMETIC ACT
OCTOBER 2 (legislative day, SEPTEMBER 24), 1968,—Ordered to be printed
Mr. HILL, from the Committee on Labor and Public Welfare,
submitted the following
REPORT
[To accompany H.R. 14096]
The Committee on Labor and Public Welfare, to which was
referred the bill (H.R. 14096) to amend the Federal Food, Drug,
-------
1150 LEGAL COMPILATION—PESTICIDES
and Cosmetic Act to increase the penalties for unlawful acts
involving lysergic acid diethylamide (LSD) and other depressant
and stimulant drugs, and for other purposes, having considered
the same, reports favorably thereon with amendments and recom-
mends that the bill as amended do pass.
PRINCIPAL, PURPOSE OF THE BILL
As reported by the committee, the bill would provide increased
penalties for persons trafficking illegally in barbiturates, depres-
sants, amphetamines, and LSD and other hallucinogens, and
would make possession of barbiturates, depressants, ampheta-
mines and hallucinogenic drugs illegal, unless the drugs in ques-
tion were obtained pursuant to a valid prescription. Provision is
made for special treatment of first offenders accused of illegal
possession of the drugs in question.
Since the provisions of the bill with respect to penalties for pos-
session are intended primarily as an aid to law enforcement agen-
cies, and the other provisions provide increased penalties for acts
already made illegal, it is not anticipated that any increased appro-
priations would be required to carry out this act.
[p.l]
PENALTIES FOR POSSESSION
In the 1965 Drug Abuse Control Amendments, possession of
dangerous drugs for personal use was not made a prohibited act,
although possession for purposes of sale or other disposition to
another outside of legitimate channels of trade was made a pro-
hibited act, subject to fine and imprisonment.
A number of physicians feel that possession for personal use
should be controlled through educational programs, and not
through making such possession a criminal offense. This feeling
appears to be based generally upon the theory that the adverse
effects, particularly on the young, of arrest and prosecution, with
the possibility of consequent criminal records, overweigh the
adverse effects of drug abuse.
This approach of course, involves subjective judgments, balanc-
ing adverse physical and psychological effects of drug abuse
against the psychological effects of fear of arrest, and possible
arrest and prosecution. The view that possession should not be a
prohibited act is not however a view unanimously held by the
medical profession.
In general, law enforcement officers favor making possession
of drugs illegally obtained a prohibited act. Not only does the pres-
ence of such a penalty in the law operate as a deterrent, penalties
-------
STATUTES AND LEGISLATIVE HISTORY 1151
for possession serve greatly to aid in law enforcement. It is fre-
quently difficult to obtain evidence sufficient to sustain a success-
ful prosecution against a person trafficking in drugs; however,
where the possession of such drugs is illegal, arrests and prose-
cution for possession can serve to take these traffickers out of
circulation and thereby curtail illicit traffic in these drugs.
A further reason for making the possession of dangerous drugs
obtained illicitly a prohibited act is to counter the feeling among
[p-4]
some young people that abuse of dangerous drugs is not detrimen-
tal to them, since there is no penalty for personal abuse.
[p. 5]
INCREASED PENALTIES FOR TRAFFICKING IN DANGEROUS DRUGS
Under existing law (sec. 301 of the Federal Food, Drug, and
Cosmetic Act), the following are prohibited acts:
(1) Manufacture, compounding, or processing of a con-
trolled barbiturate, depressant, amphetamine, or hallucino-
gen outside legitimate channels of trade;
(2) Sale, delivery, or other disposition of such a drug
outside legitimate channels of trade; and
(3) Possession of such dangerous drug except where
obtained through legitimate channels, and except for per-
sonal use by the possessor or a member of his household or
for administration to an animal owned by him or a member
of his household.
Violation of any of the above provisions is subject to the same
penalties as are prescribed for other violations of the Food and
Drug Act; namely up to 1 year imprisonment or $1,000 fine, or
both, for a first offense and up to 3 years imprisonment or up to
$10,000 fine, or both, for a second or subsequent offense, or for
a first offense committed with intent to defraud or mislead. High-
er penalties are prescribed for illegal sales of controlled drugs
to minors.
The reported bill follows the recommendations of the adminis-
tration, and makes all offenses involving illegal trafficking in con-
trolled barbiturates, amphetamines, or hallucinogens a felony,
subject to imprisonment of up to 5 years, or a fine of up to $10,000,
or both. In case of a sale to a minor by a person over the age of 18,
the penalties prescribed in the bill are up to 10 years' imprison-
ment for a first offense or a fine of not more than $15,000, or both,
and in the case of a second or subsequent offense, imprisonment
for more than 15 years or a fine of not more than $20,000, or both.
[p. 8]
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1152 LEGAL COMPILATION—PESTICIDES
SECTION-BY-SECTION SUMMARY OF THE COMMITTEE AMENDMENTS
Revision of penalties for offenses involving depressant or stimulant
drugs
Section 3 of the legislation makes a general revision in the
penalties prescribed in section 303 of the act for offenses involving
depressant or stimulant drugs. Examples of such offenses are the
unlawful manufacturing, sale, and possession of those drugs, and
failure to comply with recordkeeping, plant inspection, and pre-
scription requirements.
The penalties under existing law are as follows:
(1) A first offense involving a depressant or stimulant drug
committed without the intent to defraud or mislead is a misde-
meanor punishable by a fine not exceeding $1,000 or imprison-
ment for not more than a year, or both. [p. 9]
(2) A second or subsequent offense or one committed with the
intent to defraud or mislead is a felony punishable by a fine not
exceeding $10,000 or imprisonment for not more than 3 years,
or both.
(3) There is an exception to the provisions described in the
preceding paragraphs. If a person 18 or over sells or otherwise
unlawfully disposes of a depressant or stimulant drug to a per-
son under 21, the penalty for the first offense is a fine not exceed-
ing $5,000 or imprisonment for not more than 2 years, or both,
but if the offense is committed with the intent to defraud or mis-
lead, the penalty would be the one described in paragraph (2).
The penalty for second or subsequent offenses is a fine not exceed-
ing $15,000 or imprisonment for not more than 6 years, or both.
The legislation makes the following changes:
(1) In general, if the offense involves the unlawful manufac-
turing of, sale or other disposal of, or possession with intent to
sell, a depressant or stimulant drug or involves counterfeit depres-
sant or stimulant drugs, the penalty (prescribed in the new sec.
303 (b) (1) of the act) is a fine not exceeding $10,000 or impris-
onment for not more than 5 years, or both.
(2) A stiffer penalty is provided in the new section 303 (b)
(2) of the act for unlawful sales or other disposals or depressant
or stimulant drugs by persons over 18 to persons under 21. The
penalty for the first offense is a fine not exceeding $15,000 or
imprisonment for not more than 10 years, or both. The penalty
provision for second or subsequent offenses increases the maxi-
mum fine to $20,000 and the maximum imprisonment to 15 years.
(3) The penalty in the new section 303 (b) (3) for possession
of a depressant or stimulant drug for purposes other than sale or
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STATUTES AND LEGISLATIVE HISTORY 1153
other disposal is a fine not exceeding $1,000 or imprisonment for
not to exceed 1 year, or both in the case of a first or second offense.
The penalty for a third or subsequent offense for such possession
would be a maximum fine of $10,000 and maximum imprison-
ment of 3 years, or both. A special provision is included for a per-
son whose conviction for such possession is his first conviction
for any offense under the act. The court may suspend the imposi-
tion or execution of sentence on that person and place him on pro-
bation for not to exceed 1 year. If the court unconditionally dis-
charges that person from probation prior to the prescribed proba-
tion period or if he completes his probation period without violat-
ing any of the conditions of his probation, the conviction of that
person is automatically set aside. This provision is similar to
provisions in the Federal Youth Corrections Act (18 U.S.C. 5005-
5026).
[p. 10]
PENALTIES
[SEC. 303. (a) Any person who violates any of the provisions
of section 301 shall be guilty of a misdemeanor and shall on con-
viction thereof be subject to imprisonment for not more than one
year, or a fine of not more than $1,000, or both such imprison-
ment and fine; but if the violation is committed after a convic-
tion of such person under this section has become final such per-
son shall be subject to imprisonment for not more than three
years, or a fine of not more than $10,000, or both such imprison-
ment and fine: Provided, however, That any person who, having
attained his eighteenth birthday, violates section 301 (q) (2) by
selling, delivering, or otherwise disposing of any depressant or
stimulant drug to a person who has not attained his twenty-first
birthday shall, if there be no previous conviction of such person
under this section which has become final, be subject to imprison-
ment for not more than two years, or a fine of not more than
$5,000, or both such imprisonment and fine, and for the second
or any subsequent conviction for such a violation shall be sub-
ject to imprisonment for not more than six years, or a fine of not
more than $15,000, or both such imprisonment and fine.
[ (b) Notwithstanding the provisions of subsection (a) of this
section, in case of a violation of any of the provisions of section
301, with intent to defraud or mislead, the penalty shall (except
in the case of an offense which is subject to the provisions of the
proviso to subsection (a) relating to second or subsequent of-
fenses) be imprisonment for not more than three years, or a fine of
not more than $10,000, or both such imprisonment and fine.]
-------
1154 LEGAL COMPILATION—PESTICIDES
SEC. 303 (a) Any person who violates a provision of section
301 (other than a provision referred to in subsection (b) of this
section) shall be imprisoned for not more than one year or fined
not more than $1,000, or both; except that if any person commits
such a violation after a conviction of him under this subsection
has become final, or commits such a violation with the intent to
defraud or mislead, such person shall be imprisoned for not more
than three years or fined not more than $10,000, or both.
(b) (1) Any person who violates clause (1), (2), or (3) (A) of
section 301 (q), or violates, with respect to a depressant or stim-
ulant drug, any of the provisions of paragraph (3) of section 301
(i), shall, except as otherwise provided in paragraph (2) of this
subsection, be imprisoned for not more than five years or fined
not more than $10,000, or both.
(2) Any person eighteen or older who violates clause (2) of
section 301 (q) by selling, delivering, or otherwise disposing of
any depressant or stimulant drug to a person who is under twenty-
one, shall be imprisoned for not more than ten years or fined not
more than $15,000, or both, except that if any person commits
such a violation after a conviction of him under this paragraph
has become final, he shall be imprisoned for not more than fifteen
years or fined not more than $20,000, or both.
(3) (A) Except as otherwise provided in this subparagraph or
in subparagraph (B), any person who violates clause (3)(B) of
section 301 (q) shall be imprisoned for not more than one year or
fined not more than $1,000, or both. If any person commits such
a violation after two prior convictions of him for violation of
such clause have become final, he shall be imprisoned for not
[p. 14]
more than three years or fined not more than $10,000, or both.
(B) In the case of any person who is convicted for the first time
of violating a provision of section 301 (q) and whose conviction was
for violating clause (3) (B) of such section, the court may suspend
the imposition or execution of sentence and place such person on
probation subject to such conditions as the court may impose and
for such period, not to exceed one year, as the court may prescribe.
The court may, in its discretion, unconditionally discharge such
person from probation prior to the expiration of the maximum
period prescribed for such person's probation. Such discharge
shall automatically set aside the conviction, and the court shall
issue to such person a certificate to that effect. If during the period
of his probation such person does not violate any of the conditions
-------
STATUTES AND LEGISLATIVE HISTORY 1155
of his probation, his conviction shall at the expiration of such
period be automatically set aside, and the court shall issue to such
person a, certificate to that effect.
(c) No person shall be subject to the penalties of subsection (a)
of this section, (1) for having received in interstate commerce any
article and delivered it or proffered delivery of it, if such delivery
or proffer was made in good faith, unless he refuses to furnish on
request of an officer or employee duly designated by the Secretary
the name and address of the person from whom he purchased or
received such article and copies of all documents, if any there be,
pertaining to the delivery of the article to him; or (2) for having
violated section 301 (a) or (d), if he establishes a guaranty or
undertaking signed by, and containing the name and address of,
the person residing in the United States from whom he received
in good faith the article, to the effect, in case of an alleged violation
of section 301 (a), that such article is not adulterated or mis-
branded, within the meaning of this Act, designating this Act, or
to the effect, in case of an alleged violation of section 301 (d) that
such article is not an article which may not, under the provisions
of section 404 or 405, be introduced into interstate commerce; or
(3) for having violated section 301 (a), where the violation exists
because the article is adulterated by reason of containing a color
additive not from a batch certified in accordance with regulations
promulgated by the Secretary under this Act, if such person estab-
lishes a guaranty or undertaking signed by, and containing the
name and address of, the manufacturer of the color additive, to the
effect that such color additive was from a batch certified in accord-
ance with the applicable regulations promulgated by the Secretary
under this Act; or (4) for having violated section 301 (b), (c), or
(k) by failure to comply with section 502 (f) in respect to an article
received in interstate commerce to which neither section 503 (a)
nor section 503 (b) (1) is applicable, if the delivery or proffered
delivery was made in good faith and the labeling at the time thereof
contained the same directions for use and warning statements as
were contained in the labeling at the time of such receipt of such
article; or (5) for having violated section 301 (i) (2) if such person
acted in good faith and had no reason to believe that use of the
punch, die, plate, stone, or other thing involved would result in a
drug1 being a counterfeit drug, or for having violated section
301 (i) (3) if the person doing the act or causing it to be done acted
in good faith and had no reason to believe that the drug was a
counterfeit drug.
[p. 15]
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1156 LEGAL COMPILATION—PESTICIDES
1.13g (3) COMMITTEE OF CONFERENCE
H.R. REP. No. 1958, 90th Cong., 2d Sess. (1968)
INCREASING PENALTIES FOR UNLAWFUL ACTS IN-
VOLVING LSD AND OTHER DEPRESSANT AND STIMU-
LANT DRUGS
OCTOBER 9 (legislative day, OCTOBER 8), 1968.—Ordered to be printed
MR. STAGGERS, from the committee of conference,
submitted the following
CONFERENCE REPORT
[To accompany H.R. 14096]
The committee of conference on the disagreeing votes of the two
Houses on the amendments of the Senate to the bill (H.R. 14096)
to amend the Federal Food, Drug, and Cosmetic Act to increase the
penalties for unlawful acts involving lysergic acid diethylamide
(LSD) and other depressant and stimulant drugs, and for other
purposes, having met, after full and free conference, have agreed
to recommend and do recommend to their respective Houses as
follows:
That the House recede from its disagreement to the amendments
of the Senate numbered 1, 2, 3, 4, and 5, and agree to the same.
HARLEY O. STAGGERS,
JOHN JAEMAN,
PAUL G. ROGERS,
DAVID E. SATTERFIELD III,
W. L. SPRINGER,
ANCHER NELSEN,
TIM LEE CARTER,
Managers on the Part of the House.
LISTER HILL,
RALPH W. YARBOROUGH,
HARRISON WILLIAMS,
CLAIBORNE PELL,
EDWARD KENNEDY,
J. JAVTTS,
GEORGE MURPHY,
PETER H. DOMINICK,
Managers on the Part of the Senate.
[p.l]
-------
STATUTES AND LEGISLATIVE HISTORY 1157
STATEMENT OF THE MANAGERS ON THE PART OF THE
HOUSE
The managers on the part of the House to the conference on the
disagreeing votes of the two Houses on the amendments of the
Senate to the bill (H.R. 14096) to amend the Federal Food, Drug,
and Cosmetic Act to increase the penalties for unlawful acts in-
volving lysergic acid diethylamide (LSD) and other depressant
and stimulant drugs, and for other purposes, submit the following
statement in explanation of the effect of the action agreed upon by
the conferees and recommended in the accompanying conference
report:
Amendment No. 1: This amendment changes the penalty pro-
vided in the House bill for convictions for the unlawful possession
for personal use of depressant or stimulant drugs. The House bill
provided a penalty of imprisonment for not more than 1 year, or a
fine of not more than $1,000, or both, if there had been no previous
conviction for violations of section 301 (q) of the Federal Food,
Drug, and Cosmetic Act (relating to certain unlawful acts involv-
ing depressant or stimulant drugs), and imprisonment for not
more than 3 years, or a fine of not more than $10,000, or both, if
there was a previous conviction for violating such section. The
Senate amendment provided a penalty of imprisonment for not
more than 1 year, a fine of not more than $1,000, or both, for the
first two convictions for such unlawful possession (irrespective of
any prior convictions for violations of such section 301 (q)), and
provided a penalty of imprisonment for not more than 3 years, a
fine of not more than $10,000, or both, for subsequent convictions
for such unlawful possession. The House recedes.
Amendment No. 2: This amendment makes certain provisions of
the Federal Food, Drug, and Cosmetic Act relating to depressant
or stimulant drugs, their containers, and the equipment used to
manufacture, compound, or process them applicable to the Canal
Zone. The House recedes.
Amendments Nos. 3 and 4: These amendments are conforming
amendments to amendment No. 2. The House recedes.
-------
1158
LEGAL COMPILATION—PESTICIDES
Amendment No. 5: This amendment amends the act establishing
the National Eye Institute in the National Institutes of Health by
changing the name of the National Institute of Neurological Dis-
eases and Blindness to the National Institute of Neurological Dis-
eases and Stroke. The House recedes.
HARLEY 0. STAGGERS,
JOHN JARMAN,
PAUL G. ROGERS,
DAVID E. SATTERFIELD III,
W. L. SPRINGER,
ANCHER NELSEN,
TIM LEE CARTER,
Managers on the Part of the House.
[p. 2]
1.13g (4) CONGRESSIONAL RECORD, VOL. 114 (1968)
1.13g (4) (a)
21040
July 12: Amended and passed House, pp. 21032-
INCREASING PENALTIES FOR
UNLAWFUL ACTS INVOLVING
LSD AND OTHER DEPRESSANT
AND STIMULANT DRUGS
Mr. STAGGERS. Mr. Speaker, I ask
unanimous consent that the bill (H.R.
14096) to amend the Federal Food,
Drug, and Cosmetic Act to prescribe
penalties for the possession of LSD and
other hallucinogenic drugs by unau-
thorized persons, be considered in the
House as in the Committee of the
Whole.
The Clerk read the title of the bill.
The SPEAKER. Is there objection to
the request of the gentleman from
West Virginia?
There was no objection.
The Clerk read the bill, as follows:
H.R. 14096
Be it enacted by the Senate and House of
Representatives of the United States of America
in Congress assembled. That (a) (1) section 201
of the Federal Food, Drug, end Cosmetic Act
(21 U.S.C. 321) is amended hy adding at the end
thereof the following new paragraph:
"(w) The term 'hallucinogenic drug' means
lysergic acid diethylamide or any other depres-
sant or stimulant drug which the Secretary,
after investigation, has found to have, and by
regulation designates as having, hallucinogenic
properties similar to those of lysergic acid
diethylamide. The provisions of subsections (e),
(f), and (g) of section 701 shall apply to and
govern proceedings for the issuance, amend-
ment, or repeal of regulations under this para-
graph."
(2) Section 611(g)(l) of such Act (21 U.S.C.
360a(g)(l)) 13 amended (A) by inserting "or
under section 201(w)" immediately after "sec-
tion 201 (v)" the first time it appears in such
section, and (B) by inserting "or pursuant to
section 201 (w)" immediately after "section
201 (V)" the second time it appears in such
section.
(b) Section 611 (c) of such Act (21 U.S.C.
360a(c)) is amended—
(1) by inserting "other than a hallucinogenic
drug)" immediately after "depressant or stimu-
lant drug" in the first sentence;
(2) by striking out in the second sentence "of
this subsection" and inserting in lieu thereof
"of the preceding sentence"; and
(3) by adding at the end thereof the following
new sentence: "No person, other than a person
described in subsection (a) or subsection (b)(2),
shall possess any hallucinogenic drug; except
pursuant to a prescription by a duly licensed
practitioner."
With the following committee amend-
ment:
Strike out all after the enacting clause and
insert:
"That section 201 (v) (3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321) is
amended by striking out 'any drug' and insert-
-------
STATUTES AND LEGISLATIVE HISTORY
1159
ing in lieu thereof 'lysergic acid diethylamide
and any other drug*.
"SEC. 2. (a) Section 611 (c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
360a (c)) is amended to read as follows:
" '(c) No person, other than a person de-
scribed in subsection (a) or (b) (2) of this
section, shall—
" '(1) possess any depressant or stimulant
drug for sale, delivery, or other disposal to
another, or
'' '(2) otherwise possess any such drug unless
such drug was obtained directly, or pursuant
to a valid prescription, from a practitioner
(licensed by law to prescribe or administer such
drug) while acting in the course of his profes-
sional practice.'
"(b) Clause (3) of paragraph (q) of section
301 of such Act (21 U.S.C. 331 (q) (3)) is
amended to read as follows: '(3) (A) the posses-
sion of a drug in violation of section Bll(c)(l),
or (B) the possession of a drug in violation of
section 511 (c) (2) ;'.
"SEC. 3. Section 303 of such Act (21 U.S.C.
333) is amended by striking out subsections (a)
and (b) and inserting in lieu thereof the fol-
lowing new subsections:
" 'SEC. 303. (a) Any person who violates a
provision of section 301 (other than a provision
referred to in subsection (b) of this section)
shall be imprisoned for not more than one year
or fined not more than $1,000, or both; except
that if any person commits such a violation
after a conviction of him under this subsection
haa become final, or commits such a violation
with the intent to defraud or mislead, such
person shall be imprisoned for not more than
three years or fined not more than $10,000, or
both.
" '(b) (1) Any person who violates clause (1),
(2), or (3) (A) of section 301(q), or violates,
with respect to a depressant or stimulant drug,
any of the provisions of paragraph (3) of
section 301 (i), shall, except as otherwise pro-
vided in paragraph (2) of this subsection be
imprisoned for not more than five years or fined
not more than $10,000, or both.
" '(2) Any person eighteen or older who
violates clause (2) of section 301 (q) by selling,
delivering, or otherwise disposing of any de-
pressant or stimulant drug to a person who is
under twenty-one, shall be imprisoned for not
more than ten years or fined not more than
$15,000, or both, except that if any person
commits such a violation after a conviction of
him under this paragraph has become final, he
shall be imprisoned for not more than fifteen
years or fined not more than $20,000, or both.
"'(3) (A) Except as provided in subparagraph
(B) of this paragraph, any person who violates
clause (3) (B) of section 301(q) shall (1) be
imprisoned for not more than one year or fined
not more than $1,000, or both, if he has not
been convicted of violating any provision of
section 301 (q) prior to his conviction for vio-
lating: such clause, or (2) be imprisoned for not
more than three years or fined not more than
$10,000, or both, if he has been convicted of
violating a provision of such section prior to
his conviction for violating such clause.
'"(B) In the case of any person who is
convicted for the first time of violating a pro-
vision of section 301 (q) and whose conviction
was for violating clause (3) (B) of such section,
the court may suspend the imposition or execu-
tion of sentence and place such person on
probation subject to such conditions as the court
may impose and for such period, not to exceed
one year, as the court may prescribe. The court
may, in its discretion, unconditionally discharge
such person from probation prior to the expira-
tion of the maximum period prescribed for such
person's probation. Such discharge shall auto-
matically set aside the conviction, and the court
shall issue to such person a certificate to that
effect. If during the period of his probation such
person doea not violate any of the conditions of
his probation, his conviction shall at the expira-
tion of such period be automatically set aside,
and the court shall issue to such person a cer-
tificate to that effect.'
"SEC. 4. It is the sense of the Congress that,
bee ause of the inadequate knowledge on the
part of the people of the United States of the
substantial adverse effects of misuse of depres-
sant and stimulant drugs, and of other drugs
liable to abuse, on the individual, hia family,
and the community, the highest priority should
be given to Federal programs to disseminate
information which may be used to educate the
public, particularly young persons, regarding
the dangers of drug abuse.
"SEC. 6. The amendments made by this Act
shall apply only with respect to violations of
the Federal Food, Drug, and Cosmetic Act
committed after the date of the enactment of
this Act."
Mr. STAGGERS (during the read-
ing) . Mr. Speaker, I ask unanimous
consent that the committee amendment
be considered as read, printed in the
RECORD, and open to amendment at any
point.
The SPEAKER. Is there objection to
the request of the gentleman from
West Virginia?
There was no objection.
Mr. STAGGERS. Mr. Speaker, I
move to strike the last word.
Mr. Speaker, the bill before the
House today is intended to strengthen
the laws against drug abuse which is
one of the most serious health prob-
lems facing the United States today.
In recent years, the abuse of amphet-
-------
1160
LEGAL COMPILATION—PESTICIDES
amines, barbiturates, and hallucino-
gens such as LSD and the like has in-
creased a great deal particularly
among the young.
The bill fundamentally does two
things. First, it increases substantially
the penalties for illegal trafficking in
drugs covered by the Drug Abuse Con-
trol Amendments of 1965, and second,
it makes possession of these drugs for
one's own use a misdemeanor in the
case of the first offense, and a felony
for the second and subsequent offenses.
In general, people who abuse drugs
take them as a means of escape. For
one reason or another they cannot face
the world they live in without some
kind of a crutch and tend to turn to
drugs for that crutch, frequently with
serious adverse effects on their health.
There is also some abuse of drugs by
persons who are merely experimenting
with them. Sometimes the experiment-
ers do no more than just that; some-
times however, they damage their
health in the process.
Drug abuse is a serious problem in
our society, and those who cater to this
market are among the lowest types of
human beings.
With respect to pushers, this legis-
lation provides greatly strengthened
penalties. Existing law provides that
for a first offense of manufacturing or
selling drugs subject to control under
the Food and Drug Act, the penalty is
1 year imprisonment and a $1,000 fine,
and for a second offense the penalty is
3 years and $10,000. The bill increases
these penalties to provide for up to
5 years imprisonment and $10,000 fine
[p.21032]
or both for illegal trafficking in these
drugs.
As an aid to law enforcement, the
bill also makes possession of these
drugs obtained without a valid pre-
scription, a criminal offense. A first
offender against the possession prohi-
bition will be guilty of a misdemeanor
with possible imprisonment up to 1
year and a fine of up to $1,000. A sec-
ond or subsequent violation of the pos-
session prohibition will lead up to 3
years imprisonment or up to $10,000
fine, or both.
Unfortunately, there is fairly wide-
spread abuse of drugs among the
young. During our hearings it was
pointed out that in one high school in
the United States, a survey indicated
that over 8 percent of the students had
tried LSD. Now, no one wants to put
high school students in jail and, simi-
larly, no one wants to take college stu-
dents and other young people who may
be just experimenting a time or two
and throw them into jail. For that rea-
son, our committee put a provision in
the bill to the effect that where a per-
son is convicted for a first offense of
possession of one of these drugs for
his own use, the court may suspend
any sentence and place the offender on
probation for up to 1 year. If the of-
fender fully complies with the terms
and conditions of his probation, his
conviction will be automatically set
aside so that he does not thereby ob-
tain a criminal record.
Mr. Speaker, drug abuse is a serious
problem in America today and our
committee has reported a bill to the
House that we believe will go a long
way toward curbing this problem.
I urge my colleagues to support the
bill as reported.
*****
Mr. ROGERS of Florida. Mr. Speak-
er, I move to strike the requisite num-
ber of words.
Mr. Speaker, last November 20 I was
joined by 23 of my colleagues on the
Interstate and Foreign Commerce
Committee in sponsoring a bill to make
possession of LSD and other hallucino-
genic drugs by unauthorized persons
a Federal crime.
At the time I was shocked to learn
that with all the work the Congress
has done in the field of food, drugs, and
cosmetics, there was no Federal pen-
alty prescribed for the use of lysergic
acid diethylamide, better known as
-------
STATUTES AND LEGISLATIVE HISTORY
1161
LSD, or other hallucinogenic drugs by
persons who have obtained the drug
illegally.
There are existing penalties for the
unauthorized manufacture, distribu-
tion, and selling of the drug, yet no
penalty for its use.
Thus, there existed a dilemma for
the law enforcement officers; they
would have ample evidence to conduct
a raid where marijuana and LSD were
being used. They could arrest those
who were smoking marijuana, but
they could not arrest those who had
taken LSD, or who had LSD in their
possession for their own use, unless
proof was available to link those pos-
sessing LSD with another person who
illegally manufactured, distributed, or
sold the drug to those possessing it at
the time of the raid.
Mr. Speaker, the bill before the
House today will correct that gap in
the law.
This bill, H.R. 14096, which I intro-
duced, with amendments we adopted in
committee, increases the penalties for
persons who deal illegally in stimu-
lant, depressant, and hallucinogenic
drugs. The bill makes possession of
such drugs a misdemeanor on the first
[p.21033]
offense unless the drugs in question
were obtained pursuant to a valid pre-
scription. Second and subsequent of-
fenses would be a felony.
*****
This bill would prescribe penalties
for abuse of the so-called dangerous
drugs: Non-narcotic drugs that are
habit forming or have a potential for
abuse because of their stimulant, de-
pressant, or hallucinogenic effect.
The hallucinogens vary in their
chemical makeup, but the most widely
known is LSD, lysergic acid diethaly-
mide. Others include peyote, Mescaline,
and Psilocybin.
By this bill, LSD is specifically in-
cluded in section 201 (v) (3) of the Fed-
eral Food, Drug, and Cosmetic Act (21
U.S.C. 321) as well as any other drug
which contains any quantity of a sub-
stance which now the Attorney Gen-
eral of the United States after investi-
gation, has found to have, and by regu-
lation designates as having, a poten-
tial for abuse because of its hallucino-
genic effect.
The Attorney General also has the
benefit of a drug advisory committee
which can offer assistance and recom-
mendations concerning the stimulant,
depressant or hallucinogenic effect of
existing drugs, or any new drugs which
may be manufactured.
There is ample time and proper pro-
cedure for objection to the Attorney
General's ruling on a specific drug, and
such ruling is to be printed in the Fed-
eral Register.
*****
The penalties prescribed in the bill
are realistic, and were formulated af-
ter extensive deliberation by the sub-
committee after hearing all thf. testi-
mony.
We do not wish to make criminals
out of a half million high school stu-
dents in the Nation who may take LSD
on one occasion.
But, we do not wish to condone such
acts.
This bill strikes a balance.
This bill makes possession of dan-
gerous drugs a misdemeanor on the
first offense subject to imprisonment
up to 1 year, and a fine up to $1,000.
However, the bill also provides that
where an individual is charged with
simple possession of dangerous drugs
obtained without a doctor's prescrip-
tion, and he has not previously been
convicted of a violation of the law with
respect to dangerous drugs, the court
may, in lieu of a fine or imprisonment,
place the person upon probation for a
period, up to 1 year, as the court might
determine, subject to such conditions
as the court may impose, such as re-
quired psychiatric treatment.
[p. 21034]
Mr. BROWN of Ohio.
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1162
LEGAL COMPILATION—PESTICIDES
Without this law, possession and use
or sale would still be legal although
sale was not permitted. My original
proposal would have made felonies pos-
session as well as use. The bill on which
we are voting today, however, makes
first offense possession only a misde-
meanor- [p. 21035]
Mr. HALPERN. Mr. Speaker, it is
high time that we faced up to the
reality of the dangers of LSD and
other hallucinogenic drugs and enacted
tough penalties for their possession.
As a sponsor of similar legislation, I
am gratified to note that the bill before
us today fills the enforcement vacuum
that has heretofore existed.
This bill provides strong penalties
for trafficking in these dangerous
drugs. It is my hope that these penal-
ties will act as effective deterrents to
both the clandestine manufacturer and
his crony, the despicable dope pusher.
The plight of the individual drug
user, however, presents an entirely dif-
ferent problem. I am pleased to call to
your attention that this difficult situa-
tion is handled in H.R. 14096 in a most
constructive manner, as I shall point
out. The bill makes possession of dan-
gerous hallucinogenic drugs legal only
when such drugs are given to a person
by a practitioner authorized to dis-
pense them, or upon the legal order
for such drugs, as represented in the
form of a prescription from a medical
practitioner.
Since hallucinogenic drugs are not
available through normal channels of
distribution, the possession of LSD and
similar drugs will, in most cases, be
illegal, and subject the possessor to
fine or imprisonment. Under present
Federal law, Federal authorities may
seize any quantity of such drugs from
an individual as contraband items ob-
tained from illegal sources, but no ac-
tion may be taken with respect to the
possessor himself where the drugs are
for his personal use.
Under the legislation before us to-
day, however, possession of depressant
or stimulant drugs for the purpose of
sale or other disposal is subject to
tough penalties. Simple possession is
made illegal, but in the case of a first
conviction for any offense under the
food and drug law, the court may sus-
pend sentencing, and place the offender
on probation which may not exceed 1
year. Thus there is a humanitarian
aspect to this tough bill. If the indi-
vidual completes his probation satis-
factorily, or is otherwise uncondition-
ally discharged from his probation
period by the court, the conviction will
be set aside.
Mr. Speaker, there can be no doubt
that this legislation deals effectively
with the hallucinogenic-drug abuse
problem that exists in our society to-
day. The members of the Interstate
and Foreign Commerce Committee are
to be congratulated for the intelligent
manner in which they have approached
this grave, nevertheless delicate prob-
lem. They have acted with force, yet,
at the same time, have acted humane-
ly, for the bill they have presented to
us strikes a balance between varying
enforcement and medical viewpoints
about how to deal with drug abuse
wisely.
I urge the unanimous approval of
this bill.
Mr. MACHEN. Mr. Speaker, I rise
today to give my full support to H.R.
14096. We have needed legislation pre-
scribing stringent penalties for the un-
authorized possession of LSD and
other hallucinogenic drugs for some
time. The penalties provided in the bill
we are now considering are stringent
enough to be a great aid to law en-
forcement officials in cutting off this
drug traffic. They will also serve to
make it clear that possession of these
drugs is not fashionable and counter
the idea that seems to have developed
among some of our young people that
abuse of these drugs is not detrimental
to them because there was no penalty
for their unauthorized possession.
[p. 21036]
-------
STATUTES AND LEGISLATIVE HISTORY
1163
Mr. WIDNALL.
*****
This bill, therefore, strikes a balance
between differing points of view on the
imposition of penalties for possession
of dangerous drugs. Strict penalties
are provided for possession, both as an
aid to law enforcement and as a deter-
rent. At the same time, however, a first
offender of the prohibition against
mere possession may, in lieu of fine or
imprisonment, be placed on probation
by the court for no longer than a year.
The court may prescribe the terms of
this probation such as the obtaining of
psychiatric help, and following the
completion of the probationary period,
the conviction is automatically set
aside to eliminate any criminal record.
The SPEAKER. The question is on
the engrossment and third reading of
the bill.
The bill was ordered to be engrossed
and read a third time, and was read
the third time.
The SPEAKER. The question is on
the passage of the bill.
The question was taken; and the
Speaker announced that the ayes ap-
peared to have it.
Mr. SPRINGER. Mr. Speaker, I ob-
ject to the vote on the ground that a
quorum is not present and make the
point of order that quorum is not pres-
ent.
The SPEAKER. Evidently a Quorum
is not present.
The Doorkeeper will close the doors,
the Sergeant at Arms will notify ab-
sent Members, and the Clerk will call
the roll.
The question was taken and there
were—yeas 320, nays 2, not voting 111,
as follows:
*****
[p. 21040]
1.13g (4) (b) Oct. 4: Amended and passed Senate, pp. 29633, 29634
AMENDMENT OF THE FEDERAL
FOOD, DRUG, AND COSMETIC ACT
Mr. MANSFIELD. Mr. President, I
ask unanimous consent that the Senate
proceed to the consideration of Calen-
dar No. 1598, H.R. 14096, which I
understand can be disposed of briefly.
The PRESIDING OFFICER. The
bill will be stated by title for the in-
formation of the Senate.
The LEGISLATIVE CLERK. A bill (H.R.
14096) to amend the Federal Food,
Drug, and Cosmetic Act to increase
the penalties for unlawful acts involv-
ing lysergic acid diethylamide—LSD
—and other depressant and stimulant
drugs, and for other purposes.
The PRESIDING OFFICER. (Mr.
HART in the chair). Is there objection
to the request of the Senator from
Montana ?
There being no objection, the Senate
proceeded to consider the bill, which
had been reported from the Committee
on Labor and Public Welfare, with
amendments on page 3, after line 18,
strike out:
(3) (A) Except as provided in subparagrarh
(B) of this paragraph, any person who violates
clause (3)(B) of section 301(q) shall (1) be
imprisoned for not more than one year or fined
not more than $1,000, or both, if he has not
been convicted of violating any provision of
section 301 (q) prior to his conviction for violat-
ing: such clause, or (2) be imprisoned for not
more than three years or fined not more than
$10,000, or both if he has been convicted of vio-
lating a provision of such section prior to his
conviction for violating such clause.
And in lieu thereof, insert:
(3) (A) Except as otherwise provided in this
subparagraph or in subparagraph (B), any
person who violates clause (3)(B) of section
301 (q) shall be imprisoned for not more than
one year or fined not more than $1,000, or both.
If any person commits such a violation after
two prior convictions of him for violation of
such clause have become final, he shall be im-
prisoned for not more than three years or fined
not more than $10,000, or both.
On page 5, after line 3, insert a new
section, as follows:
SBC. 4. (a) Section 201 (a) (2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
321 (a) (2)) is amended by striking out the period
-------
1164
LEGAL COMPILATION—PESTICIDES
at the end thereof and inserting in lieu thereof
the following: " ; except that such term includes
the Canal Zone for the purposes of sections
201, 301(1), 301 (p), 301 (q), 302, SOS, 304 (other
than paragraph (1) of subsection (a)), 307,
610, 511, 702, 703, 704, and 705 aa they apply to
depressant or stimulant drugs, containers
thereof and equipment used in manufacturing,
compounding or processing any such drug."
(b) Section 304(a) of such Act (21 U.S.C.
334 (a)), is amended by inserting "or United
States court of a Territory" after "district court
of the United States" wherever these words
occur.
At the beginning of line 18, change
the section number from "4" to "5";
and oft page 6, at the beginning of line
3, change the section number from "5"
to "6".
Mr. HILL. Mr. President, I have the
honor to submit to the Senate H.R.
14096 to amend the Federal Food,
Drug, and Cosmetic Act to increase the
penalties for unlawful acts involving
LSD and depressant and stimulant
drugs. This legislation was approved
in the House of Representatives by a
vote of 319 yeas and 2 nays. The Com-
mittee on Labor and Public Welfare
approved H.R. 14096 without a dis-
senting vote.
Mr. President, under existing law it
is illegal for unauthorized persons to
[p. 29633]
manufacture, sell, deliver, or otherwise
dispose of certain hallucinogenic, stim-
ulant, and depressant drugs and to
possess such drugs for other than
personal use. The penalty for a first
offense is a maximum fine of $1,000 or
imprisonment for not more than 1
year or both such fine and imprison-
ment; H.R. 14096 would increase the
maximum fine to $10,000 and extend
the period of imprisonment to not more
than 5 years. In the case of a conviction
for a second or subsequent offense, the
present penalty is a maximum fine of
$10,000 or imprisonment for not more
than 3 years, or both such fine and im-
prisonment; H.R. 14096 would increase
the maximum term of imprisonment to
5 years.
There is an exception to the penal-
ties described above in the case of an
individual 18 years of age or older
selling or otherwise disposing of a
dangerous drug to someone who is
under 21 years of age. The penalty for
a first offense is a maximum fine of
$5,000 or imprisonment for not more
than 2 years, or both; H.R. 14096
would increase the maximum fine to
$15,000 and the term of imprisonment
to a maximum of 10 years. For a
second or subsequent offense, the pen-
alty is a maximum fine of $15,000 or
imprisonment of up to 6 years, or both;
H.R. 14096 would increase the fine to
$20,000 and the maximum imprison-
ment to 15 years.
Under existing law it is legal for an
individual to have dangerous drugs in
his possession for use by himself, a
member of his household, or an animal
of the household. H.R. 14096 would
require a valid prescription from a
licensed practitioner for such posses-
sion. The penalty for a first offense or
a second offense would be a maximum
fine of $1,000 or imprisonment, for up
to 1 year, or both. H.R. 14096 specifies
that a court may suspend sentence and
place the individual on probation in the
case of a first conviction. For a third
offense, and subsequent offenses, the
maximum fine would be $10,000 and the
maximum period of imprisonment
would be 3 years.
The enactment of this legislation
that is recommended by the Depart-
ment of Justice is essential if we are
to effectively combat the increasing
illegal traffic in dangerous drugs.
Mr. President, I ask unanimous con-
sent that the committee amendments
be considered en bloc.
The PRESIDING OFFICER. With-
out objection, the amendments are
considered and agreed to en bloc.
The bill is open to further amend-
ment.
Mr. HILL. Mr. President, I send to
the desk an amendment and ask that it
be stated.
-------
STATUTES AND LEGISLATIVE HISTORY
1165
It has seen the devastating effects
of heroin among young people who
live in the slums of our large cities.
It has studied the so-called "nice
drugs," the amphetamines and barbitu-
rates which are used and abused in
the affluent suburbs.
More recently, we held hearings on
marihuana smoking among college stu-
dents.
And it was this subcommittee which
in 1965 first considered the need for
new controls over LSD and the other
hallucinogenic drugs.
In that connection, I want to point
out a few things about this bill which
will increase the penalties for unlawful
acts involving LSD and the other
dangerous drugs covered under the
Federal Food, Drug, and Cosmetic Act.
Mr. President, there is wide agree-
ment that the drug problem is growing
more serious every day.
Last year in California alone arrests
of young people for marihuana viola-
tions increased 180 percent.
There was a reported 400-percent
growth in drug arrests in Baltimore,
Md.
And there appears to have been a
similar upsurge of drug abuse in other
parts of the country.
While there has been a decrease in
the use of LSD there is an opposite
trend with respect to marihuana and
we have been told that some 20 percent
of our college students have used mari-
huana.
We have also been told that in sev-
eral areas of the country, as many as
75 percent of high school students have
smoked marihuana.
The PRESIDING OFFICER. The
amendment will be stated.
The legislative clerk read as follows:
On page 6, after line 6, insert a new section,
as follows:
"SEC. 7. The last sentence of Public Law
90-489 is amended to read as follows: "The
name of the National Institute of Neurological
Diseases and Blindness is hereby changed to the
'National Institute of Neurological Diseases and
Stroke.' "
Mr. HILL. Mr. President, this amend-
ment is needed to correct a technical
error in Public Law 90-489 that
changed the name of the National In-
stitute of Neurological Diseases and
Blindness. Since that act created a
National Eye Institute there is no
longer any need for a reference to
blindness in the title of the National
Institute of Neurological Diseases and
Blindness. My amendment, therefore,
would change the name of the institute
to the National Institute of Neurologi-
cal Diseases and Stroke. This new title
will give recognition to the research
effort of the Institute against stroke,
a health problem that causes 200,000
deaths each year.
The PRESIDING OFFICER. The
question is on agreeing to the amend-
ment of the Senator from Alabama
[Mr. HILL].
The amendment was agreed to.
The PRESIDING OFFICER. The
bill is open to further amendment. If
there be no further amendment to be
proposed, the question is on the en-
grossment of the amendments and
third reading of the bill.
The amendments were ordered to be
engrossed and the bill to be read a
third time.
The bill was read the third time, and
passed. [p 29634]
1.13g (4) (c) Oct. 11: House agrees to conference report, pp. 30761,
30762
INCREASING PENALTIES FOR
UNLAWFUL ACTS INVOLVING
LSD AND OTHER DEPRESSANT
AND STIMULANT DRUGS
Mr. FRIEDEL. Mr. Speaker, I call
up the conference report on the bill
(H.R. 14096) to amend the Federal
Food, Drug, and Cosmetic Act, to in-
crease the penalties for unlawful acts
involving lysergic acid diethylamide
(LSD) and other depressant and
stimulant drugs, and for other pur-
-------
1166
LEGAL COMPILATION—PESTICIDES
poses, and ask unanimous consent that
the statement of the managers on the
part of the House be read in lieu of
the report.
The Clerk read the title of the bill.
The SPEAKER. Is there objection
to the request of the gentleman from
Maryland?
There was no objection.
The Clerk read the statement.
The conference report and statement
are as follows:
*****
[p. 30761]
Mr. PRIEDEL. (during the read-
ing). Mr. Speaker, I ask unanimous
consent that further reading of the
statement of the managers on the part
of the House be dispensed with.
The SPEAKER. Is there objection
to the request of the gentleman from
Maryland?
There was no objection.
Mr. ROGERS of Florida. Mr.
Speaker, the conference report being
considered by the House today is on a
bill passed by the House unanimously
on July 12 increasing penalties for
unlawful acts involving LSD and other
depressant or stimulant drugs.
The House bill provided that posses-
sion of drugs subject to controls under
the legislation is unlawful except where
those drugs have been obtained pursu-
ant to a valid prescription. The House
bill provided that a first offense of un-
lawful possession should be a misde-
meanor with the second and all subse-
quent offenses constituting a felony.
The Senate amended the bill to provide
that both the first and second offenses
of unlawful possession should be mis-
demeanors with the third and subse-
quent offenses constituting a felony.
Another of the amendments of the
Senate makes the laws relating to de-
pressant or stimulant drugs applicable
in the Canal Zone.
The final Senate amendment would
change the name of the "National
Institute for Neurological Diseases"
to the "National Institute of Neuro-
logical Diseases and Stroke".
Mr. Speaker, the Senate conferees
were quite persuasive in their argu-
ments for the approach of the bill, as
amended by the Senate. Therefore, the
Senate amendments, and we recom-
mend that the House adopt the con-
ference report.
Mr. NELSEN. Mr. Speaker, some
time ago this House passed H.R. 14096
to provide a criminal penalty for pos-
session of LSD and similar drugs and
to increase penalties for selling them.
The Senate changed our bill in only
one respect and that was to make the
first two convictions for possession
misdemeanors rather than only the
first violation. The purposes of this
amendment to the Drug Act seem to
be accomplished by either version and
so your conferees receded.
Another entirely extraneous amend-
ment was tacked on in the other body.
This would change the name of the
National Institute of Neurological
Diseases to the National Institute of
Neurological Diseases and Stroke.
Your conferees were not in favor of
this latter amendment but when it
appeared that the very desirable
change in the LSD statute would be
sacrificed unless it remained, your
conferees receded. On balance I rec-
ommend that we accept the conference
report.
Yet, it became clear from our hear-
ings that in spite of the agreement on
the seriousness of the problem there
is much less agreement on what to do
about it.
There is at least a very basic conflict
between the law-enforcement agencies,
including the drug law-enforcement
agencies, on the one hand and the scien-
tists, researchers, and educators on the
other hand as to how the drug abuse
situation should be handled.
The first group wants strong laws
and rather severe penalties even for
simple possession of dangerous drugs,
while the other group wants no penal-
ties for possession.
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STATUTES AND LEGISLATIVE HISTORY
1167
Mr. FRIEDEL. Mr. Speaker, I move
the previous question on the conference
report.
The previous question was ordered.
The conference report was agreed to.
A motion to reconsider was laid on
the table.
[p. 30762]
1.13g (4)(d) Oct. 11: Senate agrees to conference report, pp.
30963-30965.
AMENDMENT OF FEDERAL
FOOD, DRUG, AND COSMETIC
ACT—CONFERENCE REPORT
Mr. HILL. Mr. President, I submit
a report of the committee of conference
on the disagreeing votes of the two
Houses on the amendments of the
Senate to the bill (H.R. 14096) to
amend the Federal Food, Drug, and
Cosmetic Act to increase the penalties
for unlawful acts involving lysergic
acid diethylamide (LSD) and other
depressant and stimulant drugs, and
for other purposes. I ask unanimous
consent for the present consideration
of the report.
The PRESIDING OFFICER. The
report will be read for the information
of the Senate.
The legislative clerk read the report.
(For conference report, see House
proceedings of October 11, 1968, pages
30761-30762, CONGRESSIONAL RECORD.)
The PRESIDING OFFICER. Is
there objection to the present consider-
ation of the report?
There being no objection, the Senate
proceeded to consider the report.
Mr. HILL. Mr. President, this con-
ference report is signed by all of the
conferees on the part of the Senate and
by all of the conferees on the part of
the House.
As passed by the House, the penalty
for a conviction for possesion of a
dangerous drug, for purposes other
than sale, delivery, or other disposal
to another, in the absence of a valid
prescription from a licensed practi-
tioner, is imprisonment for up to 1
year or a fine of not more than $1,000,
or both, if the individual has not been
convicted for a violation under the
drug abuse control amendments. If
there is a previous conviction, the
penalty would be imprisonment for up
to 3 years or a fine of not more than
$10,000, or both.
The Senate amendment provides
that the penalty for such illegal pos-
session of dangerous drugs would be
imprisonment for not more than 1 year
or a fine of not more than $1,000, or
both, except that the penalty would be
imprisonment for not more than 3
years or a fine of not more than
$10,000, or both, for violations after
two prior convictions for such illegal
possession have become final. The
House receded.
The second Senate amendment car-
ried out the recommendations of the
Canal Zone Government and the De-
partment of Justice to make the Canal
Zone subject to the provisions of the
drug abuse control amendments. The
House receded. The House also receded
on the third and fourth amendments
of the Senate that renumbered two
sections of H.R. 14096.
Finally, the fifth Senate amendment
corrected a technical error in Public
Law 90-489, the legislation that es-
tablished a National Eye Institute by
changing the name of the National
Institute of Neurological Diseases and
Blindness to "National Institute of
Neurological Diseases and Stroke."
The House receded.
Mr. DOt>D. Mr. President, I have
some brief comments on the bill that
has just emerged from the House-
Senate conference to establish new
penalties for drug violations.
The Juvenile Delinquency Subcom-
mittee has devoted a great deal of time
to the study of drug abuse in the
Nation.
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1168
LEGAL COMPILATION—PESTICIDES
Many police officers believe that long
sentences are a deterrent to crime, the
[p.30963]
scientists believe they increase disre-
spect toward the law among youth.
The majority of law-enforcement of-
ficers believe that severe penalties can
keep young people in line, the other
side gives evidence that such harsh
treatment increases what the scientists
call alienation of youth from adults
and from the society at large.
Having adopted H.R. 14096 we must
still give some recognition to this con-
flict because we have not solved it with
this legislation and we will have to
make further efforts to resolve the con-
troversy.
Mr. President, I am convinced today,
as I have been for some years that in
time the best way to deal with our pres-
ent narcotic and dangerous drug prob-
lem will be a comprehensive review of
our entire framework of drug laws
with a view to making sweeping revi-
sions in these laws.
At this late hour of the 90th Con-
gress, such action cannot be accom-
plished.
Therefore, I have supported the bill
before us, but only in anticipation of a
review of all our drug laws in the near
future, and in anticipation of the de-
velopment of a more adequate system
of drug laws and drug control proce-
dures.
Having studied the drug issue for a
number of years, I have strong views
on this matter.
For one, I cannot support the posi-
tion of the witnesses who have testified
before our committee in behalf of more
punitive drug laws and longer sen-
tences.
I think today we are compiling suf-
ficient evidence that it is not the length
of the penal sentence which restrains a
potential lawbreaker, but it is rather
the certainty of apprehension and pun-
ishment. A recent study conducted in
California substantiates this conclu-
sion. And our criminologists and ex-
perts on the penal system have held
this conviction for a good number of
years.
On the other hand, neither do I think
any of the dangerous drugs, including
marihuana, should be legalized or oth-
erwise made available to the public
without proper controls in the case of
prescriptive drugs and without penal-
ties for violation in the case of all
drugs covered under the Food and
Drug Act or under any other law.
I think no person should possess
marihuana, LSD, or any drug contrary
to the provisions of law and not suffer
the consequences.
However, such offenses do not neces-
sarily call for a 5- or a 10-year term of
imprisonment.
Such severe penalties are presently
possible for the possession of marihua-
na. Yet, they have not prevented the
spectacular rise of marihuana abuse.
The bill before us does not deal with
marihuana, but rather with LSD and
the other drugs covered by the Food,
Drug, and Cosmetic Act.
The penalties which it suggests for
simple possession are far less severe
than in the case of marihuana.
In fact, this bill as passed by the
House of Representatives and as adop-
ted in the Senate Labor and Public
Welfare Committee, would provide for
setting aside of convictions for certain
first and second offenses so that no
criminal involvement would mar the
record of a young person apprehended
with LSD or another controlled drug.
I think this is a considerable im-
provement over the previous versions
of this bill which would have made pos-
session offense an unqualified misde-
meanor.
For this reason, I supported this bill
and refrained from introducing a sub-
stitute proposal.
Nevertheless, I believe there is a
loophole in this measure which would
make some of the penalties it proposes
particularly for the transfer of drugs
highly inequitable and unjust.
-------
STATUTES AND LEGISLATIVE HISTORY
1169
Therefore, I asked Senator HILL to
spell out the congressional intent re-
garding this measure in the accom-
panying Senate report.
My concern is with those sections of
the bill prescribing felony penalties for
"selling, delivering, or otherwise dis-
posing of any depressant or stimulant
drug."
Indeed I had prepared an amend-
ment that would differentiate between
the penalties applicable to the sale of
these drugs on the one hand and to the
delivery or other disposal on the other
hand.
It would have made felony penalties
applicable only to the illegal sale or
possession for sale or other commercial
transfer of drugs. And it would have
applied only misdemeanor penalties to
other delivery or disposal of these
drugs.
Our hearings have confirmed that
the main objective of this bill should
be to get at the commercial and crimi-
nal trafficker who sells these drugs for
profit to our citizens and particularly
to young people.
I fully agree that we need substan-
tial penalties for these illegal commer-
cial transactions.
But language in the bill dealing with
the delivery or other disposal of a drug
to another creates a serious problem
that should not have been bypassed.
This language going beyond the sale
to delivery or other disposal of the
control drugs could make felons out of
hundreds of thousands of law-abiding
citizens.
It can, in fact, throw our system of
justice and of law back to the dark ages
when men could be hanged for as triv-
ial a crime as picking pockets.
And, if misused, it would, in effect,
invade millions of American homes
with the threat of a hard and inequi-
table law. Mr. President, under the
provisions spelled out in this legisla-
tion, a mother giving one of her own
sleeping pills to her daughter could
go to prison for 10 years because of an
essentially humanitarian act.
If we impose the same penalties for
any type of disposal of these drugs to
another as we do for the sale of these
drugs we, in effect, make a felon out
of a. college student who gives just one
amphetamine pill to a friend to help
him stay awake to prepare for an ex-
amination. And we make a felon out of
any individual who, however unwisely
from a medical standpoint, but with
the best motivation and without any
criminal intent, gives a sleeping pill or
a pep pill to a friend.
All these individuals can be subject
to a felony record and in many cases to
a 10-year prison term under the pro-
visions of this bill.
Certainly, it is not good practice for
any layman to give any medicine to an-
other. This should be the prerogative
of a physician. Nevertheless, we are
dealing with reality here and our hear-
ings prove that this happens every day
all over the country among essentially
law-abiding people.
Wrong as this may be, I insist that
these people are not felons and should
not be made such under this law.
Mr. President, I can stand the
thought of a young college student fac-
ing a misdemeanor charge for passing
a pep pill to a friend because the judge
can fine him $10 and his conviction may
even be expunged. But I think it in-
credible that such a young person or
any of the other persons I have men-
tioned could be made felons and sent to
prison for 10 years because of this rela-
tively trivial crime.
At a time when our system of crimi-
nal justice tends to emphasize treat-
ment and rehabilitation, to expand
probation, work-release programs, and
other noninstitutional correction, it is
an incredible paradox to create a new
felony offense and threaten perhaps
millions of our people, many of them
young, many of them our brightest col-
lege students.
Ours is a drug-infested society where
-------
1170
LEGAL COMPILATION—PESTICIDES
prescription drugs and other control
drugs are passed from one person to
another. But, when no commercial pur-
pose or criminal intent is involved in
these transactions they should not be
subject to felony convictions because
of a eatchall phrase in the bill.
Let me emphasize that large variety
of the barbiturate- or amphetamine-
type drugs have become standard items
in millions of medicine cabinets in
American homes.
And, I venture to say that in millions
of homes these drugs are acquired on
prescription by one member of the fam-
ily but are used by several other mem-
bers as well.
Under this bill, which was intro-
duced mainly because of the public's
fear of LSD, we will now have millions
of new felons in the Nation every time
medicine cabinets are opened and one
member of the family gives a pill with
stimulant or depressant properties to
another member.
This is what has concerned me about
the provisions of this bill. They are
acceptable when applied to the traffic
in LSD, but they are outrageous if
applied across the board to every
transfer of a control drug by one per-
son to another, even if the law is not
enforced in these instances.
This is why I considered amending the
bill to allow felony penalties only for
violations in connection with commer-
cial transfer of the drugs controlled
by the Food, Drug, and Cosmetic Act.
The Justice Department asked me to
withhold the amendment. The Depart-
ment claims that in many cases, prose-
cution becomes impossible if a sale or
the intent to sell has to be proved.
I am not convinced that this is a le-
gitimate argument. And I will look at
it more closely when the Juvenile De-
linquency Subcommittee resumes hear-
ings on drug abuse next year.
At this time, however, the Justice
Department has given assurance that
felony indictments would not be insti-
L30964]
tuted in cases of noncommercial pos-
session or transfer of small amounts
of drugs.
Senator HILL has included that as-
surance in the language of the report
and with that expression of congres-
sional intent in this matter, I think we
have achieved some protection against
the possibility of inequitable applica-
tion of the law.
In that light, I think the bill will
promote a more effective procedure for
controlling the drug menace.
I want to commend the President for
offering this bill as a part of his broad
crime control program.
I want to commend Senator HILL for
his able management of the bill in the
Senate.
And, with the qualifications I have
outlined, I want to commend this bill to
the public as an expression and a part
of this administration's active and ef-
fective effort to control the serious
crime problem in the Nation.
Mr. HILL. Mr. President, I move the
adoption of the report.
The PRESIDING OFFICER. The
question is on agreeing to the confer-
ence report.
The report was agreed to.
[p.30965]
1.13h COMPREHENSIVE DRUG ABUSE PREVENTION AND
CONTROL ACT
October 27,1970, P.L. 91-513, Title II, §701(b), 84 Stat. 1281
REPEALS AND CONPOEMING AMENDMENTS
SEC. 701. (a) Sections 201 (v), 301 (q), and 511 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321 (v), 331 (q), 360(a)
are repealed.
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STATUTES AND LEGISLATIVE HISTORY 1171
(b) Subsections (a) and (b) of the section 303 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 333) are amended to
read as follows :
"SEC. 303. (a) Any person who violates a provision of section
301 shall be imprisoned for not more than one year or fined not
more than $1,000, or both.
"(b) Notwithstanding the provisions of subsection (a) of this
section, if any person commits such a violation after a conviction
of him under this section has become final, or commits such a viola-
tion with the intent to defraud or mislead, such person shall be
imprisoned for not more than three years or fined not more than
$10,000 or both."
1.13h (1) SENATE COMMITTEE ON THE JUDICIARY
S. REP. No. 91-613, 91st Cong., 1st Sess. (1969)
CONTROLLED DANGEROUS SUBSTANCES ACT OF 1969
DECEMBER 16,1969.—Ordered to be printed
MR. DODD, from the Committee on the Judiciary, submitted the
following
REPORT
together with
ADDITIONAL VIEWS
[To accompany S. 3246]
The Committee on the Judiciary, having under consideration
legislation to protect the public health and safety by amending the
narcotic, depressant, stimulant and hallucinogenic drug laws, and
for other purposes, reports an original bill and recommends that it
do pass.
NEW PROVISIONS ADDED IN COMMITTEE
The original bill generally follows the basic language and struc-
ture of both S. 1895 and S. 2637. However, three major provisions
were added to the basic bill in committee which were originally
contained in S. 1895. One of these provisions is designed to change
the penalty structure applicable to drug offenses under title V. The
other provision adds certain tranquilizers to the list of "controlled
substances" under title II. And the third provision is designed to
establish a committee to study marihuana.
The penalty provision was added based on evidence developed
through subcommittee investigations and hearings which indicated
-------
1172 LEGAL COMPILATION—PESTICIDES
that the penalties provided in S. 2637 were inconsistent as com-
pared with the harmfulness, abuse characteristics and their social
implications of the several classes of drugs. For example, to impose
the same high mandatory penalties for marihuana-related offenses
as for LSD and heroin offenses is inequitable in the face of a con-
siderable amount ef evidence that marihuana is significantly less
harmful and dangerous than LSD or heroin.
[p. 1]
PURPOSE OP THE BILL
The bill was a necessary reaction to the reorganization of drug
control agencies carried out under President Johnson's Adminis-
tration in 1968. Under the reorganization plan the drug enforce-
ment agencies of the Department of Health, Education, and Wel-
fare and of the Treasury Department (except those involved with
customs) were transferred to the Department of Justice.
The next step was to collect the diverse drug control and enforce-
ment laws under one piece of legislation to facilitate law enforce-
ment, drug research, educational and related control activities.
Equally, the purpose expressed in the bill is to classify the drugs
subject to control in specific schedules according to the chemical
properties, psychological and physical effects and abuse potential
of the different drugs. Based on this classification, the schedules
developed were then made to correspond to the penalties appli-
cable to violations involving the different classes of drugs.
The basic elements of the penalty structure are described in sub-
sequent sections of the report.
Furthermore, the overall purpose of the bill is to improve the
administration and regulation of the manufacture, importation and
exportation of the controlled dangerous substances covered under
its provisions, so that the widespread diversion presently occur-
ring can be halted.
[p. 3]
TITLE VII—ENFORCEMENT PROVISIONS
Under this title, enforcement personnel of the Bureau of Nar-
cotics and Dangerous Drugs are vested with broader enforcement
powers required for the effective enforcement of this act.
The title provides for search warrants which allow entry without
notice into premises for the purpose of seizing property that might
otherwise be destroyed or to protect human life. This is a vital pro-
vision to help law enforcement officers obtain evidence for criminal
proceedings against traffickers in controlled dangerous substances.
The ability to prosecute these offenders often depends on the
[p. 9]
amount of drugs found on the premises. At the same time these
-------
STATUTES AND LEGISLATIVE HISTORY 1173
substances can be easily destroyed in a relatively short period of
time.
Apprehension of the serious traffickers and illicit manufacturers
of drugs is probably the most effective way to control the drug
problem. The so-called no-knock provision established by this title
is an invaluable legal device to help achieve this objective.
It also provides administrative inspections and warrants and
criteria for forfeiture of certain property which is substantially
involved in drug violations.
It further provides for notification to be given in certain cases
to individuals against whom criminal proceedings are to be insti-
tuted under this act and for privilege and immunity against self-
incrimination for witnesses compelled to testify in proceedings
initiated under this act. In addition, it places the burden of proof
on a person involved in litigation under the act to rebut the pre-
sumption by the Government that such person has violated any
registration or recordkeeping requirements. Equally, the title
protects Federal enforcement officers from liability for law en-
forcement activities relating to controlled dangerous substances
and provides for the expenditure of certain Federal funds in pay-
ment to persons giving information concerning violations of the
act.
[p.10]
TITLE VII—ENFORCEMENT PROVISIONS
Section 701. Powers of Enforcement Personnel
Section 701 (a) incorporates and expands upon 21 U.S.C. 372 (c)
and 26 U.S.C. 7607, Section 372 (e) contains the authority granted
to agents of the former Bureau of Drug Abuse Control by the
Drug Abuse Control Amendment of 1965. Section 7607 contains
the authority granted to agents of the former Bureau of Narcotics.
The authorities in each of the above sections have been carried
over by proposed section 701 (a) of this act. These authorities
have the right to carry firearms, execute and serve search-and-
arrest warrants, subpenas, and summonses. This authority is ex-
panded to include the execution and service of administrative in-
spection warrants. This additional authority is necessary to con-
form to the Supreme Court decisions in the Camara and See cases
which require the Government to obtain warrants to make inspec-
tions—that is, accountability investigations.
Both 21 U.S.C. 372 (e) (4) and 26 U.S.C. 7607(2) granted
agents the authority to make arrests for dangerous drug and nar-
cotic drug or marihuana offenses, respectively, committed in the
agent's presence or, in the case of felonies, when the agent has
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1174 LEGAL COMPILATION—PESTICIDES
probable cause. Section 701 (a) (3) broadens this arrest authority
to include any offenses against the United States.
Section 701 (a) (4) contains the authority to seize property
which is in violation of the narcotic and dangerous drug laws.
Section 701 (a) (5) grants the agents authority to perform other
law enforcement duties as the Attorney General may designate.
This section is not aimed at any particular function, but provides
the Attorney General with flexibility in the utilization of enforce-
ment personnel.
Subsection (b) of this section provides that nothing shall dero-
gate from the authority of the Secretary of the Treasury under
the customs and related laws.
[p. 30]
1.13h (2) HOUSE COMMITTEE ON INTERSTATE AND FOR-
EIGN COMMERCE
H.R. REP. No. 91-1444, (Parts 1 & 2), 91st Cong., 2d Sess. (1970)
COMPREHENSIVE DRUG ABUSE PREVENTION AND
CONTROL ACT OF 1970
SEPTEMBER 10,1970.—Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
ME. STAGGERS, from the Committee on Interstate and Foreign
Commerce, submitted the following
REPORT
[To accompany H.R. 18583]
The Committee on Interstate and Foreign Commerce, to whom
was referred the bill (H.R. 18583) to amend the Public Health
Service Act and other laws to provide increased research into, and
prevention of, drug abuse and drug dependence; to provide for
treatment and rehabilitation of drug abusers and drug dependent
persons; and to strengthen existing law enforcement authority in
the field of drug abuse, having considered the same, report favor-
ably thereon with an amendment and recommend that the bill as
amended do pass.
The amendment strikes out all after the enacting clause and
inserts a new text, which is set forth in italic in the reported bill.
PRINCIPAL PURPOSE OF THE BILL
This legislation is designed to deal in a comprehensive fashion
with the growing menace of drug abuse in the United States (1)
-------
STATUTES AND LEGISLATIVE HISTORY 1175
through providing authority for increased efforts in drug abuse
prevention and rehabilitation of users, (2) through providing more
effective means for law enforcement aspects of drug abuse preven-
tion and control, and (3) by providing for an overall balanced
scheme of criminal penalties for offenses involving drugs.
[p-1]
PART G—CONFORMING, TRANSITIONAL AND EFFECTIVE DATE, AND
GENERAL PROVISIONS
Section 701—Repeals and conforming amendments
Section 701 deletes from the Federal Food, Drug, and Cosmetic
Act the provisions relating to depressant or stimulant drugs in-
serted by the Drug Abuse Control Amendments of 1965, and the
1968 penalty amendments, and makes conforming amendments to
the Federal Food, Drug, and Cosmetic Act, section 302 (a) of the
Public Health Service Act, and sections 1111 and 1952 of title 18 of
the U.S. Code. Section 302 (a) of the Public Health Service Act,
which now requires the Service to investigate the use and misuse
of narcotic drugs and advise the Attorney General on the quantities
of narcotic drugs necessary to supply U.S. medicinal and scientific
requirements, is also broadened so as to require research in drug
abuse and drug dependence for all controlled substances and to
require the Service to advise the Attorney General on domestic
requirements for all such substances.
See, also, sections 1101 and 1102 of the bill with respect to repeals
of, and conforming amendments to, laws within the jurisdiction of
the Ways and Means Committee. .
PART II
COMPREHENSIVE DRUG ABUSE PREVENTION AND
CONTROL ACT OF 1970
SEPTEMBER 10, 1970.—Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
MR. STAGGERS, from the Committee on Interstate and Foreign
Commerce, submitted the following
CHANGES IN EXISTING LAW
[To accompany H.R. 18583]
CHANGES IN EXISTING LAW MADE BY THE BILL, AS
REPORTED
In compliance with clause 3 of rule III of the Rules of the House
of Representatives, changes in existing law made by the bill, as
-------
1176 LEGAL COMPILATION—PESTICIDES
reported, are shown as follows (existing law proposed to be omitted
is enclosed in black brackets, new matter is printed in italic, exist-
ing law in which no change is proposed is shown in roman) :
FEDERAL FOOD, DRUG, AND COSMETIC ACT
*******
CHAPTER II—DEFINITIONS
SEC. 201. For the purposes of this Act—
(a) (1) The term "State", except as used in the last sentence of
section 702 (a), means any State or Territory of the United States,
the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The Term "Territory" means any Territory or possession of
the United States, including the District of Columbia, and exclud-
ing the Commonwealth of Puerto Rico and the Canal Zone [ :except
that such term includes the Canal Zone for the purposes of sections
201, 301 (i), 301 (p), 301 (q), 302, 303, 304 (other than paragraph
(1) of subsection (a)), 307, 510, 511, 702, 703, 704, and 705 as
they apply to depressant or stimulant drugs, containers thereof
and equipment used in manufacturing, compounding or processing
any such drug]. .. -,
*******
Sec. 303. (a,) Any person who violates a provision of section 301
shall be imprisoned for not more than one year or fined not more
than $1,000 or both.
(b) Notwithstanding the provisions of subsection (a) of this sec-
tion, if any person commits such a violation after a conviction of
him under this section has become final, or commits such a violation
with the intent to defraud or mislead, such person shall be im-
prisoned for not more than three years or fined not more than
$10,000, or both. r 0,
Lp. oj
1.13h (3) COMMITTEE OF CONFERENCE
H.R. REP. No. 91-1603, 9lst Cong., 2d Sess. (1970)
COMPREHENSIVE DRUG ABUSE PREVENTION AND
CONTROL ACT OF 1970
OCTOBER 13,1970.—Ordered to be printed
MR. STAGGERS, from the committee of conference,
submitted the following
CONFERENCE REPORT
[To accompany H.R. 18583]
The committee of conference on the disagreeing votes of the two
Houses on the amendments of the Senate to the bill (H.R. 18583)
-------
STATUTES AND LEGISLATIVE HISTORY 1177
to amend the Public Health Service Act and other laws to provide
increased research into, and prevention of, drug abuse and drug
dependence; to provide for treatment and rehabilitation of drug
abusers and drug dependent persons; and to strengthen existing
law enforcement authority in the field of drug abuse, having met,
after full and free conference, have agreed to recommend and do
recommend to their respective Houses as follows:
That the Senate recede from its amendments numbered 1, 6, 7,
8, 9, 10,11, 12,13,14,15, 16, 17, 18, and 20.
That the House recede from its disagreement to the amendments
of the Senate numbered 2 and 21, and agree to the same.
Amendment numbered 3 :
That the House recede from its disagreement to the amendment
of the Senate numbered 3, and agree to the same with an amend-
ment, as follows:
In lieu of the matter proposed to be inserted by the Senate
amendment insert the following:
*******
[P.I]
1.13h(4) CONGRESSIONAL RECORD, VOL. 116 (1970)
1.13h (4) (a) Jan. 28: Considered and passed Senate, p. 1690
[No Relevant Discussion on Pertinent Section]
1.13h (4) (b) Sept. 24: Considered and passed House, p. 33667
[No Relevant Discussion on Pertinent Section]
1.13h (4)(c) Oct. 7: Amended and passed Senate, pp. 35496-
35497
[No Relevant Discussion on Pertinent Section]
1.13h (4) (d) Oct. 14: House agrees to conference report, p. 36655
[No Relevant Discussion on Pertinent Section]
1.13h (4) (e) Oct. 14: Senate agrees to conference report, p. 36885
[No Relevant Discussion on Pertinent Section]
-------
1178 LEGAL COMPILATION—PESTICIDES
1.14 RESEARCH AND DEVELOPMENT ACT, CONTRACTS,
AS AMENDED
10 U.S.C. §§2353, 2354 (1956)
[Referred to in 42 U.S.C. §241 (h) ]
THE RESEARCH AND DEVELOPMENT ACT
§ 2353. Contracts: acquisition, construction, or furnishing of
test facilities and equipment
(a) A contract of a military department for research or de-
velopment, or both, may provide for the acquisition or construc-
tion by, or furnishing to the contractor of research, developmental,
or test facilities and equipment that the Secretary of the military
department concerned determines to be necessary for the perform-
ance of the contract. The facilities and equipment, and specialized
housing for them, may be acquired or constructed at the expense
of the United States, and may be lent or leased to the contractor
with or without reimbursement, or may be sold to him at fair
value. This subsection does not authorize new construction or im-
provements having general utility.
(b) Facilities that would not be readily removable or separ-
able without unreasonable expense or unreasonable loss of value
may not be installed or constructed under this section on property
not owned by the United States, unless the contract contains—
(1) a provision for reimbursing the United States for the
fair value of the facilities at the completion or termination of
the contract or within a reasonable time thereafter;
(2) an option in the United States to acquire the under-
lying land; or
(3) an alternative provision that the Secretary concerned
considers to be adequate to protect the interests of the United
States in the facilities.
(c) Proceeds of sales or reimbursements under this section
shall be paid into the Treasury as miscellaneous receipts, except to
the extent otherwise authorized by law with respect to property
acquired by the contractor. Aug. 10, 1956, c. 1041, 70A Stat. 1S4.
§ 2354. Contracts: indemnification provisions
(a) With the approval of the Secretary of the military depart-
ment concerned, any contract of a military department for re-
search or development, or both, may provide that the United States
will indemnify the contractor against either or both of the follow-
ing, but only to the extent that they arise out of the direct per-
-------
STATUTES AND LEGISLATIVE HISTORY 1179
formance of the contract and to the extent not compensated by
insurance or otherwise:
(1) Claims (including reasonable expenses of litigation or
settlement) by third persons, including employees of the con-
tractor, for death, bodily injury, or loss of or damage to prop-
erty, from a risk that the contract defines as unusually
hazardous.
(2) Loss of or damage to property of the contractor from
a risk that the contract defines as unusually hazardous.
(b) A contract, made under subsection (a), that provides for
indemnification must also provide for—
(1) notice to the United States of any claim or suit against
the contractor for the death, bodily injury, or loss of or dam-
age to property; and
(2) control of or assistance in the defense by the United
States, at its election, of that suit or claim.
(c) No payment may be made under subsection (a) unless the
Secretary of the department concerned, or an officer or official
of his department designated by him, certifies that the amount is
just and reasonable.
(d) Upon approval by the Secretary concerned, payment under
subsection (a) may be made from—
(1) funds obligated for the performance of the contract
concerned;
(2) funds available for research or development, or both,
and not otherwise obligated; or
(3) funds appropriated for those payments. Aug. 10, 1956,
c. 1041,70A Stat. 134.
1.14a ARMED FORCES RESEARCH AND DEVELOPMENT
ACT
July 16,1952, P.L. 82-557, §§4, 5, 66 Stat. 725
SEC. 4. Any contract of the military departments for research or
development, or both, may provide for the acquisition or construc-
tion by, or furnishing to, the contractor of such research, develop-
mental, or test facilities and equipment as may be determined by
the Secretary concerned to be necessary for the performance there-
of. Such research, developmental, or test facilities and equipment,
including specialized housing therefor, may be acquired or con-
structed at Government expense, and may be furnished to the
contractor by lease, loan, or sale at fair value, and with or without
reimbursement to the Government for the use thereof: Provided,
-------
1180 LEGAL COMPILATION—PESTICIDES
That nothing contained in this subsection shall be deemed to
authorize new construction or improvements having general util-
ity: Provided further, That nothing contained herein shall be
deemed to authorize the installation or construction of facilities on
property not owned by the Government which would not be readily
removable or separable without unreasonable expense or unreason-
able loss of value, unless adequate provision is made in the contract
for (1) reimbursement to the Government of the fair value of
such facilities upon the completion or termination of the contract,
or within a reasonable time thereafter, or (2) an option in the
[p. 725]
Government to acquire the underlying land, or (3) such other
provisions as will in the opinion of the Secretary concerned be
adequate to protect the Government's interest in such facilities:
And provided further, That all money arising from sales or reim-
bursement under this section shall be covered into the Treasury as
miscellaneous receipts, except to the extent otherwise authorized by
law with respect to contractor-acquired property. The Secretary of
each of the military departments shall transmit to the Congress
reports covering contracts for research or development entered
into during each six months following the enactment of this Act.
Each such report shall contain (1) a list of each contract for
research or development entered into during such period the total
cost of which to the Government will exceed $50,000, and (2)
specific information with respect to each such contract, except that
specific information the disclosure of which he deems incompatible
with the security of the United States may be excluded from such
reports.
SEC. 5. With the approval of the Secretary concerned, any con-
tract of the military departments for research or development, or
both, may provide that the Government will indemnify the contrac-
tor against either or both of the following, to the extent that they
arise out of the direct performance of said contract and are not
compensated by insurance or otherwise: (1) Liability on account
of claims (including reasonable expenses of litigation or settlement
of such claims) by third persons, including employees of the con-
tractor, for death, bodily injury, or loss of or damage to property,
arising as a result of a risk defined in the contract to be unusually
hazardous: Provided, That any contract so providing shall also
contain appropriate provisions for notice to the Government of
suits or actions filed or claims made, against the contractor, with
respect to any alleged liability for such death, bodily injury, or loss
of or damage to property, and for control of or assistance in the
-------
STATUTES AND LEGISLATIVE HISTORY 1181
defense of any such suit, action, or claims, by the Government, at
its election; and (2) loss of or damage to property of the contrac-
tor arising as a result of a risk defined in the contract to be unusu-
ally hazardous: And provided further, That no payment shall be
made by the Government under authority of this section unless the
amount thereof shall first have been certified to be just and reason-
able by the Secretary concerned or by an official of the department
designated for such purpose by the Secretary. Any such payment
may be made, with the approval of the Secretary concerned, out
of any funds obligated for the performance of such contract or out
of funds available for research and development work and not
otherwise obligated; or out of any funds appropriated by the Con-
gress for the making of such payments.
[p. 726]
1.14a (1) HOUSE COMMITTEE ON ARMED SERVICES
H.R. REP. No. 548, 82nd Cong., 1st Sess. (1951)
FACILITATING THE PERFORMANCE OF RESEARCH AND
DEVELOPMENT WORK BY AND ON BEHALF OF THE
DEPARTMENTS OF THE ARMY, NAVY, AND AIR FORCE
JUNE 12,1951.—Committed to the Committee of the Whole House on the State
of the Union and ordered to be printed
Mr. HEBERT, from the Committee on Armed Services, submitted
the following
REPORT
[To accompany H.R. 1180]
The Committee on Armed Services, to whom was referred the bill
(H.R. 1180) to facilitate the performance of research and develop-
ment work by and on behalf of the Departments of the Army, the
Navy, and the Air Force, and for other purposes, having consid-
ered the same, report favorably thereon without amendment and
recommend that the bill do pass.
The purpose of the proposed legislation is to provide the armed
services with powers which are considered to be necessary to facil-
itate the carrying on of their research and development programs.
The recent war may truly be called the scientists' war. Of course,
the most spectacular evidence of this is the development of the
atomic bomb. Other known illustrations are the proximity fuze,
the myriad applications of radar, recoilless weapons, and the use
of infra-red in front-line combat. On the side of the enemy there
-------
1182 LEGAL COMPILATION—PESTICIDES
were such things as the V-l guided missile, and the V-2 rocket, the
sonic torpedo, and the snorkel submarine.
The significance of this for our national security in the future
has been well stated by Dr. Vannevar Bush in his report to the
President entitled, "Science—The Endless Frontier":
We cannot again rely on our allies to hold off the enemy while we struggle to
catch up. There must be more—and more adequate—military research in
peacetime.
It must be remembered that on mobilization day the enemy will
have a far greater number of men under arms than the Allied Na-
tions. The logical answer on our part appears to be an equivalent
counter-superiority in arms and equipment as a result of our "more
[p-1]
—and more adequate—military research in peacetime." The truth
of this statement has been demonstrated by the early experience of
UN troops against the mass attacks of Communists in Korea.
As a result of that experience, funds have been made available
for the acceleration of the research and development program.
Money alone, however, will not enable the military departments
to meet their research and development obligations. They must
have clear authority necessary to arrange and organize their re-
search and development work so as to secure the maximum results
for the funds expended. It is for that reason that the Armed Forces
have joined in recommending the passage of H. R. 1180.
This proposal does not require the increase of current appropria-
tions for research and development. The proposed legislation will
result in no increased cost to the Government, except to the extent
that unforeseen hazards may create liabilities under the indemnity
provisions contained in section 5 of the proposed bill. It is impos-
sible to foresee the extent of such claims under these provisions, or
even whether justifiable claims will actually be made.
Experience has shown conclusively how research and develop-
ment, its personnel, and its institutions, must have each of the ele-
ments of authority incorporated in this bill. This can be demon-
strated by analyzing the bill section by section.
SECTIONAL ANALYSIS
Section 1 provides for the establishment of research and develop-
ment advisory committees or panels and the employment of such
part-time advisory personnel in each of the military departments
as they may deem necessary in carrying out their research and
development activities. The wartime experience of the armed serv-
ices has demonstrated that such committees or panels and part-time
-------
STATUTES AND LEGISLATIVE HISTORY 1183
consultants are of immeasurable aid to the research and develop-
ment programs of the armed services, because they focus the great-
est scientific minds of the country on the planning and execution of
the research and development projects of the armed services. The
members of these committees or panels and such advisory person-
nel should be permitted to serve either with or without compensa-
tion, and should be exempted from the laws (sees. 281, 283, and 284
of title 18, U. S. Code) which contain certain statutory prohibitions
and penalties which would be applicable to all Federal employees,
for example, in regard to the participation in Government contracts
or claims against the Government. The most competent persons and
efficient firms are those we hope will accept appointments and con-
tracts with the Government, and may be in a positon to lay valid
claims against the Government. These persons and firms should
not be embarrassed by their inter-relationship while in Govern-
ment service. This section would overcome the reluctance of such
persons and firms and put them at ease in accepting such work.
Past experience has shown that it is in the best interests of the
United States to utilize the experience of the country's outstanding
industrialists, scientists, and educators who might be unwilling to
accept pay, or fearful of liabilities under the cited laws.
Section 2 authorizes the employment of scientific and technical
persons, whether or not they are citizens of the United States. It is
[p. 2]
common knowledge that many of the leading experts in these fields
are noncitizens and this authority will permit the employment of
such persons under the provisions of Public Law 600, Seventy-
ninth Congress.
Section 3 provides for long-term contracts. Research and devel-
opment programs must be planned far in advance in order to
achieve and maintain superior weapons and equipment systems.
The individual projects which contribute to the over-all programs
are unpredictable as to results and as to the length of time required
for completion. Continuing funds as authorized in Public Law 604,
Eighty-first Congress, together with a 5-year contract term plus
provision for additional 5-year contract renewals, will provide the
necessary continuity. Under the proposed system the Bureau of the
Budget and the Congress would not lose control over appropriated
funds. In the case of each activity they would be presented annual-
ly, with a single figure, representing the "bank balance" of that
activity. A large percentage of research and development activities
are conducted by contract with civilian institutions. The inability
of the military services to conform to established business prac-
-------
1184 LEGAL COMPILATION—PESTICIDES
tices in making long-term contracts seriously impairs this relation-
ship. A prospective contractor hesitates to commit a highly trained
staff, recruited with difficulty, for fear of termination of the work
when the contract is on a short-term basis. Accelerated progress in
critical fields may thus be retarded until a subsequent appropriation
to cover an amendment or a new contract can be justified. Author-
ity to place long-term contracts is considered essential to meet the
foregoing requirements.
Section 4 provides for the furnishing of necessary research, de-
velopmental or test facilities to contractors, subject to adequate
protection of the Government's interests therein. It is the com-
mittee's understanding that, under the provisions of this section, the
military departments may utilize research and development funds
for the furnishing or construction of equipment or facilities for the
use of contractors where appropriate. Wartime experience indi-
cates that situations arise in which contractors require special
facilities for the performance of their contracts. Since in many
cases these facilities would be of no use to them apart from the per-
formance of such contracts, they are unable to provide the facilities
at their own expense. On the other hand, to permit contract prices
to include sufficient amounts to cover the cost of such facilities,
would obviously be unfair to the Government in that the Govern-
ment would, in effect, be not only buying the facilities, but would
then leave them in the possession of the contractor. The solution
proposed herein is to authorize the Government to provide such
facilities, at the same time protecting its interest therein.
Section 5 provides authority for the military departments to
agree to indemnify contractors against liability and loss resulting
from injury to persons or damage to property arising out of the
direct performance of a research and development contract, to the
extent that such losses are not compensated by insurance or other-
wise. In many cases, contractors are reluctant to undertake a re-
search or development contract involving extremely hazardous
new developments without adequate protection in the event of li-
ability resulting from claims made as a result of damage from those
experiments. No provision can be made for such protection by in-
[P.3]
eluding a reserve in the contract price, and the cost of insurance,
if at all obtainable, would be prohibitive. The solution is for the
Government to agree to indemnify such a contractor, subject to
the safeguards provided in this section.
Section 6 provides authority for the Secretaries of the military
departments, with the approval of the Secretary of Defense and the
-------
STATUTES AND LEGISLATIVE HISTORY 1185
Comptroller General to promulgate regulations stating the extent
to which vouchers for funds expended under any research and de-
velopment contract shall require itemization or substantiation prior
to payment. Universities and nonprofit institutions, in which much
research is conducted, as well as some commercial organizations,
are not equipped to handle the detailed vouchering procedures and
auditing technicalities required. Difficulty is experienced in negoti-
ating contracts with these institutions for that reason. Relaxed
procedures were applied to contracts let by the Office of Scientific
Research and Development during the war and proved highly satis-
factory. The requirement of approval by the Secretary of Defense
and the Comptroller General is an important safeguard on the
extent to which this authority will be used.
Section 7 provides authority for the prompt publication of sci-
entific and technical information developed by the departments,
which will be extremely useful in disseminating such information.
Frequently, it will be advantageous for the departments to avail
themselves of specialized means of distribution of such informa-
tion, such as the use of the services and mailing lists of appropriate
learned societies. The current situation of inflation, increased costs,
and the consequent shrinkage in media of publication of scientific
work, plus increased scientific activity, has resulted in considerable
difficulty in the publication of the findings of scientific work. Scien-
tific progress is directly related to the prompt dissemination of
technical data to others who are engaged in similar work. It is to
the interest of the military service to assist in such dissemination
of information, subject to security controls. This section excludes
the publication of such material from the provisions of law which
generally require that all printing for Government agencies shall
be done at the Government Printing Office.
Section 8 authorizes the Secretaries of the military departments
to delegate any authority provided by this act to the Under or Assis-
tant Secretaries of the Departments, the Chiefs of the Technical
Services, bureaus or offices, and to one assistant of each such chief.
Such delegation of authority is normal and is considered essential
in order to achieve the necessary facility and flexibility of opera-
tion.
There can be no question that the future security of our Nation
depends largely upon our military research and development pro-
grams. The purpose of the proposed bill is to provide the armed
services with adequate means for properly discharging their re-
search and development functions.
As previously noted, it is impossible to predict unforeseen hazards
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1186 LEGAL COMPILATION—PESTICIDES
which may create liabilities under the indemnity provisions con-
tained in section 5 of the proposed bill. It is the intention of the
committee that the departments continue the current policy of hav-
ing contractors insure employees against hazards in doing research
contract work where the premiums on such insurance are not pro-
hibitively costly. It is recognized that some of the undertakings in
the research and development contracts are so hazardous that they
[p. 4]
cannot be insured in any amount. If such contracts are to be under-
taken, and the committee agrees that they must, there is no other
solution than that of having the Government agree to indemnify
the contractor if liability should be sustained by him. Except for
this possibility, the proposed legislation will result in no increased
cost to the Government.
The proposed legislation is a part of the Department of Defense
legislative program for 1951 and it has been approved by the
Bureau of the Budget. The Department of Defense recommends
that it be enacted by the Congress as is evidenced by the report of
the Secretary of Defense which is hereto attached and made a part
of this report:
ASSISTANT SECRETARY OF DEFENSE
Washington, D.C., January 5,1951.
Hon. SAM EAYBURN,
Speaker of the House of Representatives.
MY DEAR MR. SPEAKER: There is forwarded herewith a draft of legislation
"to facilitate the performance of research and development work by and on
behalf of the Army, the Navy, and the Air Force, and for other purposes,"
together with a sectional analysis thereof.
This proposed legislation is a part of the Department of Defense Legislative
Program for 1951 and it has been approved by the Bureau of the Budget. The
Department of Defense recommends that it be enacted by the Congress.
Purpose of the legislation: the purpose of this legislation is to provide the
military departments with administration authority required to carry out
research and development programs. General authority for research and
development programs of the Departments of the Army and Air Force is
provided by the Army and Air Force Authorization Act of 1949, while the
Department of the Navy carries out its research and development program
under the authority of the act of August 1, 1946 (60 Stat. 779). The National
Security Act of 1947, as amended, provides for the authority of the Secretary
of Defense and the Research and Development Board with respect to all
research and development programs of the Department of Defense. This legis-
lation is not designed to affect such general authorities and relationships but
merely to provide the military departments with administrative powers which
are essential, in order to effectively implement the general authority to conduct
such programs.
These essential powers are:
(1) The appointment of research advisory committees;
(2) The employment of alien scientists and technicians;
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STATUTES AND LEGISLATIVE HISTORY 1187
(3) The periodic renewal of research contracts;
(4) The furnishing of Government facilities;
(5) The indemnification against damage loss, where the contractor is
unable to procure insurance coverage;
(6) A simplified voucher procedure, the requirements of which can be
met by colleges, universities, institutes, and other contractors; and
(7) The publication and dissemination of scientific and technical infor-
mation.
Legislative references: Legislation similar to this proposal was introduced
in the Eightieth Congress (S. 1560). S. 1560 was passed by the Senate (S.
Rept. No. 1397), but was not reported out of the House Committee before
adjournment.
The Army and Air Force Authorization Act of 1949 (Public Law 604, 81st
Cong.) which was approved on July 10, 1950 authorized the Departments of
the Army and Air Force to conduct, engage, and participate in research and
development programs and to procure or contract for facilities, equipment,
services, and supplies to effectuate such programs. That act also provided for
the continued availability of appropriations to the Departments of the Army,
Navy, and Air Force for research and development.
Legislation identical with this proposal except for technical changes and
the omission of authority for the continued availability of appropriations for
research and development in the enclosed draft, was included in the Depart-
ment of Defense legislative program for consideration by the Eighty-first
Congress, second session, approved by the Bureau of the Budget, and intro-
duced in the Congress (S. 3521 and H.R. 8352). No further action was taken
by the Eighty-first Congress with respect to S. 3521 and H.R. 8352.
Cost and budget data: Enactment of the proposed legislation should result in
no additional expenditure of public funds, except to the extent that unforeseen
[p. 5]
hazards may create liabilities under the indemnity provisions of the proposed
legislation. It is impossible to foresee the extent of claims under those
provisions.
Department of Defense action agency: The Department of the Army has
been designated as the representative of the Department of Defense for this
legislation.
Sincerely yours,
MARX LEVA.
Existing comparable law is printed below on the left with the
bill (H.R. 1180) on the right:
EXISTING COMPARABLE LAW
ARMY AND AIR FORCE AUTHORIZATION
ACT OF 1949—RESEARCH AND
DEVELOPMENT AUTHORIZATION
(Army Authority)
SEC. 104. The Secretary of the Army
is hereby authorized to conduct, en-
gage, and participate in research and
development programs related to ac-
tivities of the Army of the United
THE BILL (H.R. 1180)
A BILL To facilitate the performance of re-
search and development work by and on
behalf of the Departments of the Army, the
Navy, and the Air Force, and for other
purposes:
That each of the Secretaries of the
military departments is hereby author-
ized to establish such advisory com-
mittees or panels as may be necessary
for the conduct of the research and
-------
1188
LEGAL COMPILATION—PESTICIDES
EXISTING COMPARABLE LAW
States and to procure, or contract for
the use of, such facilities, equipment,
services, and supplies as may be re-
quired to effectuate such programs.
(Air Force Authority)
SEC. 205. The Secretary of the Air
Force is hereby authorized to conduct,
engage, and participate in research
and development programs related to
activities of the Air Force of the United
States and to procure, or contract for
the use of, such facilities, equipment,
services, and supplies as may be re-
quired to effectuate such programs.
(Army, Navy, and Air Force
Appropriation Authority)
SEC. 303. (a) There are hereby au-
thorized to be appropriated, out of any
moneys in the Treasury of the United
States not otherwise appropriated,
such sums as may be necessary to carry
out the purposes of this Act.
(b) Moneys appropriated to the De-
partments of the Army, Navy, or Air
Force for procurement of technical
military equipment and supplies, the
construction of public works, and for
research and development, including
moneys appropriated to the Depart-
ment of the Navy for the procurement,
construction, and research and devel-
opment of guided missiles, which are
hereby authorized for the Department
of the Navy, shall remain available
until expended unless otherwise pro-
vided in the appropriation Act con-
cerned.
ACT or AUGUST 1,1946 (60 STAT. 779)
(Office of Naval Research)
* * * That there is hereby created
and established in the Office of the Sec-
retary of the Navy an Office of Naval
Research, which shall be charged with
such duties relating to (1) the en-
THE BILL (H. R. 1180)
development activities of his depart-
ment, and to employ such part-time ad-
visory personnel as they may deem nec-
essary in carying out such activities.
Persons holding other offices or posi-
tions under the United States for
which they receive compensation, while
serving as members of such commit-
tees, shall receive no additional com-
pensation for such services. Other
members of such committees and other
part-time advisory personnel so em-
ployed may serve without compensa-
tion or may receive compensation at a
rate not to exceed $50 for each day of
service, as determined by the appoint-
ing authorities.
Service of an individual as a member
of any such advisory committee, or in
any other part-time capacity for a de-
partment hereunder, shall not be con-
sidered as service bringing such indi-
vidual within the provisions of section
281, 283, or 284 of title 18, United
States Code, unless the act of such in-
dividual, which by such section is made
unlawful when performed by an in-
dividual referred to in such section, is
with respect to any particular matter
which directly involves a department
which such person is advising or in
which such department is directly
interested. The provisions of the Act
of July 12, 1870 (Revised Statutes,
3679), as amended shall not apply to
the acceptance of voluntary service
of any member of any committee or
panel authorized by this section.
SEC. 2. No provision of law prohibit-
ing employment of or payment of com-
pensation or expenses to any person
not a citizen of the United States shall
[p. 6]
apply to any expert, scientific, techni-
cal, or professional person whose ap-
pointment or employment in connec-
tion with the research and development
activities of the military departments
is determined by the Secretary con-
cerned to be necessary.
-------
STATUTES AND LEGISLATIVE HISTORY
1189
EXISTING COMPARABLE LAW
couragement, promotion, planning, in-
itiation, and coordination, of naval re-
search; (2) the conduct of naval re-
search in augmentation of and in con-
junction with the research and devel-
opment conducted by the respective bu-
reaus and other agencies and offices of
the Navy Department; and (3) the su-
pervision, administration, and control
of activities within or on behalf of the
Department of the Navy relating to
patents, inventions, trade-marks, copy-
rights, royalty payments, and matters
connected therewith; as may be pre-
scribed by the Secretary of the Navy.
All of the duties of this Office shall be
performed under the authority of the
Secretary of the Navy and its orders
shall be considered as emanating from
him and shall have full force and effect
as such.
SEC. 2. At the head of the Office of
Naval Research there shall be a Chief
of Naval Research, appointed by the
President, by and with the advice and
consent of the Senate, for a term of not
to exceed three years, from among offi-
cers not below the grade of commander
on the active list of the Navy. The
Chief of Naval Research shall have the
same rank and shall be entitled to the
same pay, allowances, and privileges
of retirement as are now or may here-
after be prescribed by or in pursuance
of law for chiefs of bureaus in the
Navy Department.
SEC. 3. An officer on the active list of
the Navy may be detailed as Assistant
Chief of Naval Research, and such offi-
cer shall receive the highest pay of his
grade and in case of the death, resig-
nation, absence, or sickness of the Chief
of Naval Research, shall, until other-
wise directed by the President as pro-
vided in Revised Statutes, section 179
(U. S. C., title 5, sec. 6), perform the
duties of such chief until his successor
is appointed or such absence or sick-
ness shall cease.
SEC. 4. The Secretary of the Navy is
hereby authorized to establish a Naval
THE BILL (H. R. 1180)
SEC. 3. Contracts of the military de-
partments for services and use of facil-
ities for research or development may
be made for a term not to exceed five
years, and may be extended for an
additional period not to exceed five
years, subject to the availability of
appropriations therefor.
SEC. 4. An contract of the military
departments for research or develop-
ment, or both, may provide for the
acquisition or construction, by, or
furnishing to, the contractor of such
research, developmental, or test facili-
ties and equipment as may be deter-
mined by the Secretary concerned to be
necessary for the performance thereof.
Such research, developmental, or test
facilities and equipment including spe-
cialized housing therefor, may be
acquired or constructed at Govern-
ment expense, and may be furnished
to the contractor by lease, loan, or sale
at fair value, and with or without re-
imbursement to the Government for
the use thereof: Provided, That noth-
ing contained in this subsection shall
be deemed to authorize new construc-
tion or improvements having general
utility: Provided further,That nothing
contained herein shall be deemed to
authorize the installation or construc-
tion of facilities on property not owned
by the Government which would not be
readily removable or separable without
unreasonable expense or unreasonable
loss of value, unless adequate provision
is made in the contract for (1) reim-
bursement to the Government of the
fair value of such facilities upon the
completion or termination of the con-
tract, or within a reasonable time
thereafter, or (2) an option in the Gov-
ernment to acquire the underlying
land, or (3) such other provisions as
will in the opinion of the Secretary
concerned be adequate to protect the
Government's interest in such facili-
ties: And provided further, That all
moneys arising from sales or reim-
bursement under this section shall be
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1190
LEGAL COMPILATION—PESTICIDES
EXISTING COMPARABLE LAW
Research Advisory Committee, which
shall consist of not exceeding fifteen
persons to be appointed by the Secre-
tary from those persons in civilian life
who are preeminent in the fields of
science, research, and development
work. One
member of such committee will be from
the field of medicine. The members of
such committee shall serve for such
term or terms as the Secretary may
specify, and shall meet at such times
as may be specified by the Secretary to
consult with and advise the Chief of
Naval Operations and the Chief of the
Office of Naval Research. Each mem-
ber of such committee shall be entitled
to compensation in the amount of $50
for each day or part of a day he shall
be in attendance at any regularly
called meeting of the committee, to-
gether with reimbursement for all
travel expenses incident to such at-
tendance : Provided, That nothing con-
tained in sections 41, 109, and 113 of
the Criminal Code (U. S. C., title 18,
sees. 93, 198, and 203) ; in Revised
Statutes, section 190 (U. S. C., title 5,
sec. 99); in section 19 (e) of the Con-
tract Settlement Act of 1944 (Public
Law 395, Seventy-eighth Congress);
or in any other provision of Federal
law imposing restrictions, require-
ments, or penalties in relation to the
employment of persons, the perform-
ance of services, or the payment or
receipt of compensation in connection
with any claim proceeding, or matter
involving the United States, shall ap-
ply to such persons solely by reason of
their appointment to and membership
on such committee.
SEC. 5. (a) There is hereby author-
ized to be appropriated such amounts
as may be necessary for the Office of
Naval Research to carry out its func-
tions as provided for herein, including
such sums as may be required for ad-
ministrative expenses, and the conduct
of research and development work in
THE BILL (H. R. 1180)
covered into the Treasury as miscel-
laneous receipts, except to the extent
otherwise authorized by law with re-
spect to contractor-acquired property.
[p. 7]
SEC. 5. With the approval of the
Secretary concerned, any contract of
the military departments for research
or development, or both, may provide
that the Government will indemnify
the contractor against either or both
of the following, to the extent that they
arise out of the direct performance of
said contract and are not compensated
by insurance or otherwise: (1) Lia-
bility on account of claims (including
reasonable expenses of litigation or
settlement of such claims) by third
persons, including employees of the
contractor, for death, bodily injury, or
loss of or damage to property, arising
as a result of a risk defined in the con-
tract to be unusually hazardous: Pro-
vided, That any contract so providing
shall also contain appropriate provi-
sions for notice to the Government of
suits or actions filed or claims made,
against the contractor, with respect to
any alleged liability for such death,
bodily injury, or loss of or damage to
property, and for control of or assist-
ance in the defense of any such suit,
action, or claims, by the Government,
at its election; and (2) loss of or dam-
age to property of the contractor aris-
ing as a result of a risk defined in the
contract to be unusually hazardous:
And provided further, That no pay-
ment shall be made by the Government
under authority of this section unless
the amount thereof shall first have
been certified to be just and reasonable
by the Secretary concerned or by an
official of the department designated
for such purpose by the Secretary. Any
such payment may be made, with the
approval of the Secretary concerned,
out of any funds obligated for the per-
formance of such contract or out of
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STATUTES AND LEGISLATIVE HISTORY
1191
EXISTING COMPARABLE LAW
Government facilities and under con-
tracts with private individuals, corpor-
ations, and educational or scientific
institutions. Sufficient information rel-
ative to estimates of appropriations
for research by the several bureaus
and offices shall be furnished to the
Chief of the Office of Naval Research
to assist him in coordinating the Navy
research program and the carrying
out of such other duties as outlined in
section 1.
(b) Any funds appropriated to en-
able the Office of Naval Research to
carry out its functions as provided for
herein shall, if obligated during the
fiscal year for which appropriated, re-
main available for expenditure for
four years following the expiration of
the fiscal year for which appropriated.
After such a four-year period, the un-
expended balances of appropriations
shall be carried to the surplus fund
and covered into the Treasury.
SEC. 6. Within the limits of avail-
able appropriations, the Secretary of
the
Navy, and, by direction of the Secre-
tary, the Chief of the Office of Naval
Research and the chiefs of all bureaus
of the Navy Department may enter
into contracts, or amendments or modi-
fications of contracts, for services and
materials necessary for the making
and securing of reports, tests, models,
apparatus, and for the conducting of
research, without performance or other
bonds, and without regard to section
3709 of the Revised Statutes (U. S. C.,
title 41, sec. 5) section 3718 of the
Revised Statutes (U. S. C., title 34,
sec. 561), section 3719 of the Revised
Statutes (U. S. C., title 34, sec. 562),
section 3720 of the Revised Statutes
(U. S. C., title 34, sec. 563), section
3722 of the Revised Statutes (U. S. C.,
title 34, sec. 572), and may make ad-
vance, progress, and other payments
with respect to such contracts without
regard to the provisions of section 3648
of the Revised Statutes (U. S. C., title
THE BILL (H. R. 1180)
funds available for research and devel-
opment work and not otherwise obli-
gated; or out of any funds appropri-
ated by the Congress for the making of
such payments.
SEC. 6. Each of the Secretaries of the
military department is authorized to
prescribe, with the approval of the
Secretary of Defense and of the Comp-
troller General of the United States,
regulations for his department stating
the extent to which vouchers for funds
expended under any contract for re-
search or development, or both, shall
be subject to itemization, substantia-
tion, or certification prior to payment,
without regard to the limitations of
other laws relating to the expenditure
of public funds and accounting there-
for.
SEC. 7. Each of the Secretaries of the
military departments is authorized to
arrange for the publication of scien-
tific and technical information result-
ing from
[p. 8]
the research and development activi-
ties of his department, so as to further
the full dissemination of information
of scientific value consistent with the
national interest without regard to the
provisions of section 87 of the Act of
January 12, 1895 (28 Stat. 662), as
amended, or of section 2 of the Act of
June 30, 1906 (34 Stat. 762), as
amended.
SEC. 8. Each of the Secretaries of the
military departments is authorized to
delegate any authority provided by
this Act to the Under Secretary or any
Assistant Secretary of his department
and, except the authority under the
second proviso in section 4 hereof, the
said Secretaries may delegate any au-
thority provided by this Act to the
chiefs of the technical services, bu-
reaus, or offices and to one assistant to
each such chief. The power to negoti-
ate, execute, and administer contracts
for research or development, or both,
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1192
LEGAL COMPILATION—PESTICIDES
EXISTING COMPARABLE LAW
31, sec. 529): Provided, That nothing
herein shall be construed to authorize
the use of the cost-plus-a-percentage-
of-cost system of contracting.
SEC. 7. The Secretary of the Navy is
authorized to transfer to the Office of
Naval Research, as in his judgment
may be necessary and appropriate,
such research and development func-
tions as are now assigned to the vari-
ous bureaus and other agencies and of-
fices of the Navy Department, together
with any or all personnel, buildings,
facilities, and other property used in
the administration thereof, including
without limitation the Special Devices
Division and the Naval Research Lab-
oratory.
NATIONAL SECURITY ACT OF 1947, AS
AMENDED BY THE NATIONAL SECURITY
ACT AMENDMENTS OF 1949.
(Research and Development Board)
"SEC. 214. (a) There is hereby estab-
lished in the Department of Defense
a Research and Development Board
(hereinafter in this section referred to
as the 'Board'). The Board shall be
composed of a Chairman, who shall be
the head thereof and who shall, subject
to the authority of the Secretary of
Defense and in respect to such matters
authorized by him, have the power of
decision on matters falling within the
jurisdiction of the Board, and two rep-
resentatives from each of the Depart-
ments of the Army, Navy, and Air
Force, to be designated by the Secre-
taries of their respective Departments.
The Chairman shall be appointed from
civilian life
by the President, by and with the ad-
vice and consent of the Senate, and
shall receive compensation at the rate
of $14,000 a year. The purpose of the
Board shall be to advise the Secretary
of Defense as to the status of scientific
research relative to the national secur-
ity, and to assist him in assuring ade-
quate provision for research and devel-
opment on scientific problems relating
THE BILL (H. E. 1180)
may be further delegated, subject to
the provisions of any other applicable
law.
[p. 9]
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STATUTES AND LEGISLATIVE HISTORY
1193
EXISTING COMPARABLE LAW
to the national security.
"(b) Subject to the authority and
direction of the Secretary of Defense,
the Board shall perform the following
duties and such other duties as the
Secretary of Defense may prescribe:
"(1) preparation of a complete and
integrated program of research and de-
velopment for military purposes;
"(2) advising with regard to trends
in scientific research relating to na-
tional security and the measures neces-
sary to assure continued and increas-
ing progress;
"(3) coordination of research and
development among the military de-
partments, and allocation among them
of responsibilities for specific pro-
grams ;
"(4) formulation of policy for the
Department of Defense in connection
with research and development mat-
ters involving agencies outside the De-
partment of Defense; and
" (5) consideration of the interaction
of research and development and strat-
egy, and advising the Joint Chiefs of
Staff in connection therewith.
"(c) When the Chairman of the
Board first appointed has taken office,
the Joint Research and Development
Board shall cease to exist and all its
records and personnel shall be trans-
ferred to the Research and Develop-
ment Board.
" (d) The Secretary of Defense shall
provide the Board with such personnel
and facilities as the Secretary may de-
termine to be required by the Board
for the performance of its functions."
THE BILL (H. E. 1180)
[p.10]
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1194 LEGAL COMPILATION—PESTICIDES
1.14a(2) SENATE COMMITTEE ON ARMED SERVICES
S. REP. No. 936, 82nd Cong., 1st Sess. (1951)
FACILITATING THE PERFORMANCE OF RESEARCH AND
DEVELOPMENT WORK BY AND ON BEHALF OF THE
DEPARTMENTS OF THE ARMY, THE NAVY, AND
THE AIR FORCE
OCTOBER 11 (legislative day, OCTOBER 1), 1951.—Ordered to be printed
MR. STENNIS, from the Committee on Armed Services, submitted
the following
REPORT
[To accompany H.R. 1180]
The Committee on Armed Services, to whom was referred the bill
H.R. 1180, to facilitate the performance of research and develop-
ment work by and on behalf of the Departments of the Army, the
Navy, and the Air Force, and for other purposes, having considered
the same, report favorably thereon, without amendments, and
recommend that the bill do pass.
PURPOSE OF THE BILL
The proposed legislation would provide the three military depart-
ments with certain administrative authority required to carry out
their research and development programs.
EXPLANATION OF THE BILL
Background of the pending bill
The bill is substantially the same as S. 1560, Eightieth Congress,
which was passed by the Senate on June 1, 1948, but concerning
which no action was taken by the House of Representatives. The
pending bill introduces no change in policy or procedure not con-
templated in S. 1560, Eightieth Congress.
General authority for research and development
The Army and Air Force Organization Act of 1949 contains
general authority for research and development programs to be
carried out by the Departments of the Army and Air Force. The
[P.I]
Department of the Navy carries out its research and development
program under the authority of the act of August 1,1946 (60 Stat.
779). The National Security Act of 1947, as amended by the Na-
tional Security Act Amendments of 1949, makes provision for the
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STATUTES AND LEGISLATIVE HISTORY 1195
authority of the Secretary of Defense and the Research and Devel-
opment Board with respect to research and development programs
within the Department of Defense.
H.R. 1180 does not disturb these general authorities and rela-
tionships but is intended to provide the three military departments
with certain administrative powers which are essential for them to
implement the general authority which they now have to conduct
such programs.
Major provisions of the bill
The more important administrative powers which the bill pro-
vides are listed below:
(1) The appointment of research advisory committees;
(2) The employment of alien scientists and technicians;
(3) The periodic renewal of research contracts;
(4) The furnishing of Government facilities ;
(5) The indemnification against damage loss, where the con-
tractor is unable to procure insurance coverage;
(6) A simplified voucher procedure, the requirements of which
can be met by colleges, universities, institutes, and other contrac-
tors ; and
(7) The publication and dissemination of scientific and technical
information.
A more detailed discussion of each of the sections of the bill is
contained in the section-by-section analysis which follows.
SECTION-BY-SECTION ANALYSIS
Section 1, Establishment of research and development advisory
committees
This section provides for the establishment of research and
advisory committees and panels and for the employment of such
part-time advisory personnel as the Secretaries deem necessary in
carrying out research and development activities.
Wartime experience demonstrated that such committees or
panels and part-time consultants were of invaluable assistance in
the conduct of research and development programs. Such groups
make it possible for the country to avail itself of the best scientific
minds to deal with both the planning and the execution of projects
of the type for which professional personnel of the armed services
are not particularly equipped.
The bill provides that members of such committees and panels
and advisory personnel may serve either with or without compen-
sation and shall be exempt from the conflict of interest sections of
title 18 of the United States Code.
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1196 LEGAL COMPILATION—PESTICIDES
The authority to pay compensation at the rate of not to exceed
$50 per day of service is comparable to that contained in the 1949
amendments to the National Security Act. It should be pointed out
that this language does not constitute a new or separate authority
for the employment of consultants. The committee is mindful of
[p. 2]
the fact that substantial numbers of consultants are already em-
ployed by the Federal Government based upon authorizations con-
tained in various appropriations acts. One of the beneficial results
of the bill S. 913 (Mr. McClellan), which would establish a Joint
Budget Committee to service and work on the Federal budget,
would be a scrutiny of the justifications for selection and employ-
ment of this category of personnel.
Section 2. Employment of noncitizens
This section authorizes the employment of scientific and tech-
nical persons, whether or not they are citizens of the United States.
Many of the experts in these fields are noncitizens and this author-
ity will permit the employment of such persons under the provi-
sions of Public Law 600, Seventy-ninth Congress.
Section 3. Contracts
This section provides for long-term contracts. Research and
development programs must be planned far in advance. The indi-
vidual projects which contribute to the over-all programs are
unpredictable both as to results and as to the length of time required
for completion. Continuing funds as authorized in the Army and
Air Force Authorization Act of 1949, together with a 5-year con-
tract term plus provision for additional 5-year contract renewals,
will provide the necessary continuity. Under the proposed system
the Bureau of the Budget and the Congress would not lose control
over appropriated funds. In the case of each activity Congress
would be presented annually with a single figure representing the
"bank balance" of that activity.
A large percentage of research and development activities are
conducted by contract with civilian institutions. The inability of
the military services to conform to established business practices
in making long-term contracts seriously impairs this relationship.
A prospective contractor hesitates to commit a highly trained staff,
recruited with difficulty, for fear of termination of the work when
the contract is on a short-term basis. Accelerated progress in
critical fields may thus be retarded until a subsequent appropria-
tion to cover an amendment or a new contract can be justified.
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STATUTES AND LEGISLATIVE HISTORY 1197
Authority to place long-term contracts is considered essential to
meet the foregoing requirements.
Section 4- Furnishing of certain essential facilities to contractors
This section provides for the furnishing of necessary research,
developmental or test facilities to contractors, subject to adequate
protection of the Government's interests therein. Under the provi-
sions of this section, the military departments may utilize research
and development funds for the furnishing or construction of equip-
ment or facilities for the use of contractors where appropriate.
Wartime experience indicates that situations arise in which con-
tractors require special facilities for the performance of their
contracts. Since in many cases these facilities would be of no use
to them apart from the performance of such contracts, they are
unable to provide the facilities at their own expense. On the other
hand, to permit contract prices to include sufficient amounts to
cover the cost of such facilities, would obviously be unfair to the
Government in that the Government would, in effect, be not only
[p. 3]
buying the facilities, but would then leave them in the possession of
the contractor. The solution proposed herein is to authorize the
Government to provide such facilities, at the same time protecting
its interest therein.
Section 5. Authority to indemnify contractors against liability and
loss arising from injury or damage
This section provides authority for the military departments to
agree to indemnify contractors against liability and loss resulting
from injury to persons or damage to property arising out of the
direct performance of a research and development contract, to the
extent that such losses are not compensated by insurance or other-
wise. In many cases, contractors are reluctant to undertake a
research or development contract involving extremely hazardous
new developments without securing adequate protection in the
event of liability resulting from claims made as a result of damage
from those experiments. No provision can be made for such protec-
tion by including a reserve in the contract price, and the cost of
insurance, if at all obtainable, would be prohibitive. The solution is
for the Government to agree to indemnify such a contractor, sub-
ject to the safeguards provided in this section.
Section 6. Simplified vouchering procedures
This section provides authority for the Secretaries of the mili-
tary departments, with the approval of the Secretary of Defense
and the Comptroller General to promulgate regulations stating the
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1198 LEGAL COMPILATION—PESTICIDES
extent to which vouchers for funds expended under any research
and development contract shall require itemization or substanti-
ation prior to payment. Universities and nonprofit institutions, in
which much research is conducted, as well as some commercial
organizations, are not equipped to handle the detailed vouchering
procedures and auditing technicalities required. Difficulty is experi-
enced in negotiating contracts with these institutions for that
reason. Relaxed procedures were applied to contracts let by the
Office of Scientific Research and Development during the war and
proved highly satisfactory. The requirement of approval by the
Secretary of Defense and the Comptroller General is an important
safeguard on the extent to which this authority will be used.
Section 7. Authorization for scientific and technical publications
This section 7 provides authority for the prompt publication of
scientific and technical information developed by the departments,
which will be extremely useful in disseminating such information.
It frequently will be advantageous for the departments to avail
themselves of specialized means of distribution of such informa-
tion, such as the use of the services and mailing lists of appropriate
learned societies. The current situation of inflation, increased costs,
and the consequent shrinkage in media of publication of scientific
work, plus increased scientific activity, has resulted in considerable
difficulty in the publication of the findings of scientific work. Scien-
tific progress is directly related to the prompt dissemination of
technical data to others who are engaged in similar work. It is to
the interest of the military service to assist in such dissemination
of information, subject to security controls. This section provides
the means to that end, and also excludes such material from the
[p. 4]
provisions of law which generally require that all printing for
Government agencies shall be done at the Government Printing
Office.
Section 8. Delegation of authority
This section authorizes the Secretaries of the military depart-
ments to delegate any authority provided by this act to the Under or
Assistant Secretaries of the Departments, the chiefs of the techni-
cal services, bureaus or offices, and to one assistant of each such
chief. Such delegation of authority is normal and is considered
essential in order to achieve the necessary facility and flexibility of
operation.
CONCLUSION
There can be no question that the future security of our Nation
-------
STATUTES AND LEGISLATIVE HISTORY 1199
depends largely upon our military research and development pro-
grams. The purpose of the proposed bill is to provide the armed
services with adequate means for properly discharging their re-
search and development responsibilities.
As previously noted, it is impossible to predict unforeseen haz-
ards which may create liabilities under the indemnity provisions
contained in section 5 of the proposed bill. It is anticipated that the
departments will continue their current policy of having contrac-
tors insure employees against hazards in doing research contract
work where the premiums on such insurance are not prohibitively
costly. It is recognized that some of the undertakings in the re-
search and development contracts are so hazardous that they can-
not be insured in any amount. If such contracts are to be under-
taken there is no other solution than that of having the Government
agree to indemnify the contractor if liability should be sustained
by him. Except for this possibility, the proposed legislation will
result in no increased cost to the Government.
RECOMMENDATION OF DEPARTMENT OF DEFENSE
The proposed legislation is a part of the Department of Defense
legislative program for 1951 and it has been approved by the
Bureau of the Budget. The Department of Defense recommends
that it be enacted by the Congress as is evidencd by the report of
the Secretary of Defense which is hereto attached and made a part
of this report.
ASSISTANT SECRETARY OF DEFENSE,
Washington 25, D. C. January 5,1951.
Hon. RICHARD B. RUSSELL,
Chairman, Committee on Armed Services,
United States Senate.
DEAR MR. CHAIRMAN : There is forwarded herewith a draft of legislation to
facilitate the performance of research and development work by and on behalf
of the Army, the Navy, and the Air Force, and for other purposes, together
with a sectional analysis thereof.
This proposed legislation is a part of the Department of Defense legislative
program for 1951 and it has been approved by the Bureau of the Budget. The
Department of Defense recommends that it be enacted by the Congress.
Purpose of the legislation.—The purpose of this legislation is to provide the
military departments with administrative authority required to carry out re-
search and development programs. General authority for research and develop-
ment programs of the Departments of the Army and Air Force is provided by
the Army and Air Force Authorization Act of 1949, while the Department of
[p. 5]
the Navy carries out its research and development program under the
authority of the act of August 1, 1946 (60 Stat. 779). The National Security
Act of 1947, as amended, provides for the authority of the Secretary of De-
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1200 LEGAL COMPILATION—PESTICIDES
fense and the Eesearch and Development Board with respect to all research
and development programs of the Department of Defense. This legislation is
not designed to affect such general authorities and relationships but merely to
provide the military departments with administrative powers which are
essential in order to effectively implement the general authority to conduct
such programs.
These essential powers are:
(1) The appointment of research advisory committees;
(2) The employment of alien scientists and technicians;
(3) The periodic renewal of research contracts;
(4) The furnishing of Government facilities;
(5) The indemnification against damage loss, where the contractor is unable
to procure insurance coverage;
(6) A simplified voucher procedure, the requirements of which can be met
by colleges, universities, institutes, and other contractors; and
(7) The publication and dissemination of scientific and technical informa-
tion.
Legislative references.—Legislation similar to this proposal was introduced
in the Eightieth Congress (S. 1560). S. 1560 was passed by the Senate (S.
Kept. No. 1397), but was not reported out of the House committee before
adjournment.
The Army and Air Force Authorization Act of 1949 (Public Law 604, 81st
Cong.) which was approved on July 10, 1950, authorized the Departments of
the Army and Air Force to conduct, engage, and participate in research and
development programs and to procure or contract for facilities, equipment,
services, and supplies to effectuate such programs. That act also provided for
the continued availability of appropriations to the Department0 of the Army,
Navy, and Air Force for research and development.
Legislation identical with this proposal except for technical changes and
the omission of authority for the continued availability of appropriations for
research and development in the enclosed draft, was included in the Depart-
ment of Defense legislative program for consideration by the Eighty-first
Congress, second session, approved by the Bureau of the Budget, and intro-
duced in the Congress (S. 3521 and H.R. 8352). No further action was taken
by the Eighty-first Congress with respect to S. 3521 and H.R. 8352.
Cost and budget data.—Enactment of the proposed legislation should result
in no additional expenditure of public funds, except to the extent that unfore-
seen hazards may create liabilities under the indemnity provisions of the
proposed legislation. It is impossible to foresee the extent of claims under
those provisions.
Department of Defense action agency.—The Department of the Army has
been designated as the representative of the Department of Defense for this
legislation.
Sincerely yours,
MARX LEVA,
-------
STATUTES AND LEGISLATIVE HISTORY 1201
The following statutes set forth existing provisions of law which
are related to the authority recommended in the proposed legisla-
tion and are included in this report as a matter of convenience:
ARMY AND AIR FORCCE AUTHORIZATION ACT OF 1949—RESEARCH AND
DEVELOPMENT AUTHORIZATION
(Army Authority)
SEC. 104. The Secretary of the Army is hereby authorized to conduct engage,
and participate in research and development programs related to activities of
the Army of the United States and to procure, or contract for the use of, such
facilities, equipment, services, and supplies as may be required to effectuate
such programs.
(Air Force Authority)
SEC. 205. The Secretary of the Air Force is hereby authorized to conduct,
engage, and participate in research and development programs related to
activities of the Air Force of the United States and to procure, or contract
for the use of, such facilities, equipment, services, and supplies as may be
required to effectuate such programs.
[p. 6]
(Army, Navy, and Air Force Appropriation Authority)
SEC. 303. (a) There are hereby authorized to be appropriated, out of any
moneys in the Treasury of the United States not otherwise appropriated, such
sums as may be necessary to carry out the purposes of this Act.
(b) Moneys appropriated to the Department of the Army, Navy, or Air
Force for procurement of technical military equipment and supplies, the con-
struction of public works, and for research and development, including moneys
appropriated to the Department of the Navy for the procurement, construction,
and research and development of guided missiles, which are hereby authorized
for the Department of the Navy, shall remain available until expended unless
otherwise provided in the appropriation Act concerned.
ACT OF AUGUST 1,1946 (60 STAT. 779)
(Office of Naval Research)
* * * That there is hereby created and established in the Office of the
Secretary of the Navy an Office of Naval Research, which shall be charged
with such duties relating to (1) the encouragement, promotion, planning,
initiation, and coordination, of naval research; (2) the conduct of naval re-
search in augmentation of and in conjunction with the research and develop-
ment conducted by the respective bureaus and other agencies and offices of the
Navy Department; and (3) the supervision, administration, and control of
activities within or on behalf of the Department of the Navy relating to
patents, inventions, trademarks, copyrights, royalty payments, and matters
connected therewith; as may be prescribed by the Secretary of the Navy. All
of the duties of this Office shall be performed under the authority of the
Secretary of the Navy and its orders shall be considered as emanating: from
him and shall have full force and effect as such.
SEC. 2. At the head of the Office of Naval Research there shall be a Chief of
Naval Research, appointed by the President, by and with the advice and
consent of the Senate, for a term of not to exceed 3 years, from among
officers not below the grade of commander on the active list of the Navy. The
-------
1202 LEGAL COMPILATION—PESTICIDES
Chief of Naval Research shall have the same rank and shall be entitled to the
same pay, allowances, and privileges of retirement as are now or may here-
after be prescribed by or in pursuance of law for chiefs of bureaus in the
Navy Department.
SEC. 3. An officer on the active list of the Navy may be detailed as Assistant
Chief of Naval Research, and such officer shall receive the highest pay of his
grade and in case of the death, resignation, absence, or sickness of the Chief of
Naval Research, shall until otherwise directed by the President as provided in
Revised Statutes, section 179 (U.S.C., title 5, sec. 6), perform the duties of
such chief until his successor is appointed or such absence or sickness shall
cease.
SEC. 4. The Secretary of the Navy is hereby authorized to establish a Naval
Research Advisory Committee, which shall consist of not exceeding fifteen
persons to be appointed by the Secretary from those persons in civilian life
who are preeminent in the fields of science, research, and development work.
One member of such committee will be from the field of medicine. The mem-
bers of such committee shall serve for such term or terms as the Secretary
may specify, and shall meet at such times as may be specified by the Secretary
to consult with and advise the Chief of Naval Operations and the Chief of
the Office of Naval Research. Each member of such committee shall be entitled
to compensation in the amount of $50 for each day or part of a day he shall
be in attendance at any regularly called meeting of the committee, together
with reimbursement for all travel expenses incident to such attendance;
Provided, That nothing contained in sections 41, 109, and 113 of the Criminal
Code (U. S. C., title 18, sees. 93, 198, and 203); in Revised Statutes, section
190 (U. S. C., title 5, sec. 99); in section 19 (e) of the Contract Settlement Act
of 1944 (Public Law 395, Seventy-eighth Congress); or in any other provision
of Federal law imposing restrictions, requirements, or penalties in relation
to the employment of persons, the performance of services, or the payment or
receipt of compensation in connection with any claim proceeding, or matter
involving the United States, shall apply to such persons solely by reason of
their appointment to and membership on such committee.
SEC. 5. (a) There is hereby authorized to be appropriated such amounts as
may be necessary for the Office of Naval Research to carry out its functions as
provided for herein, including such sums as may be required for administrative
[p. 7]
expenses, and the conduct of research and development work in Government
facilities and under contracts with private individuals, corporations, and
educational or scientific institutions. Sufficient information relative to esti-
mates of appropriations for research by the several bureaus and offices shall
be furnished to the Chief of the Office of Naval Research to assist him in
coordinating the Navy research program and the carrying out of such other
duties as outlined in section 1.
(b) Any funds appropriated to enable the Office of Naval Research to carry
out its functions as provided for herein shall, if obligated during the fiscal
year for which appropriated, remain available for expenditure for 4 years
following the expiration of the fiscal year for which appropriated. After such
a 4-year period, the unexpended balances of appropriations shall be carried
to the surplus fund and covered into the Treasury.
SEC. 6. Within the limits of available appropriations, the Secretary of the
Navy, and, by direction of the Secretary, the Chief of the Office of Naval
-------
STATUTES AND LEGISLATIVE HISTORY 1203
Research and the chiefs of all bureaus of the Navy Department may enter into
contracts, or amendments or modifications of contracts, for services and ma-
terials necessary for the making and securing of reports, tests, models, appar-
atus, and for the conducting of research, without performance or other bonds,
and without regard to section 3709 of the Revised Statutes (U. S. C., title 41,
sec. 5), section 3718 of the Revised Statutes (U. S. C., title 34, sec. 561), sec-
tion 3719 of the Revised Statutes (U. S. C., title 34, sec. 562), section 3720 of
the Revised Statutes (U. S. C., title 34, sec. 563), section 3722 of the Revised
Statues (U. S. C., title 34, sec. 572), and may make advance, progress, and
other payments with respect to such contracts without regard to the provisions
of section 3648 of the Revised Statutes (U. S. C., title 31, sec. 529) : Provided,
That nothing herein shall be construed to authorize the use of the cost-plus-a-
percentage-of-cost system of contracting.
SEC. 7. The Secretary of the Navy is authorized to transfer to the Office of
Naval Research, as in his judgment may be necessary and appropriate, such
research and development functions as are now assigned to the various bureaus
and other agencies and offices of the Navy Department, together with any or
all personnel, buildings, facilities, and other property used in the administra-
tion thereof, including without limitation the Special Devices Division and
the Naval Research Laboratory.
NATIONAL SECURITY ACT OF 1947, AS AMENDED BY THE NATIONAL SECURITY
ACT AMENDMENTS OF 1949
(Research and Development Board)
"SEC. 214. (a) There is hereby established in the Department of Defense a
Research and Development Board (hereinafter in this section referred to as
the 'Board'). The Board shall be composed of a Chairman, who shall be the
head thereof and who shall, subject to the authority of the Secretary of
Defense and in respect to such matters authorized by him, have the power of
decision on matters falling within the jurisdiction of the Board, and two repre-
sentatives from each of the Departments of the Army, Navy, and Air Force,
to be designated by the Secretaries of their respective Departments. The
Chairman shall be appointed from civilian life toy the President, by and with
the advice and consent of the Senate, and shall receive compensation at the
rate of $14,000 a year. The purpose of the Board shall be to advise the Secre-
tary of Defense as to the status of scientific research relative to the national
security, and to assist him in assuring adequate provision for research and
development on scientific problems relating- to the national security.
"(b) Subject to the authority and direction of the Secretary of Defense, the
Board shall perform the following duties and such other duties as the Secretary
of Defense may prescribe:
"(1) preparation of a complete and integrated program of research and
development for military purposes;
"(2) advising with regard to trends in scientific research relating to
national security and the measures necessary to assure continued and in-
creasing progress ;
"(3) coordination of research and development among the military depart-
ments, and allocation among them of responsibilities for specfic programs;
" (4) formulation of policy for the Department of Defense in connection with
research and development matters involving agencies outside the Department
of Defense; and
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1204
LEGAL COMPILATION—PESTICIDES
"(5) consideration of the interaction of research and development and
strategy, and advising the Joint Chiefs of Staff in connection therewith.
[p. 8]
"(c) When the Chairman of the Board first appointed has taken office, the
Joint Research and Development Board shall cease to exist and all its records
and personnel shall be transferred to the Research and Development Board.
"(d) The Secretary of Defense shall provide the Board with such personnel
and facilities as the Secretary may determine to be required by the Board for
the performance of its functions."
SEC. 303. (a) The Secretary of Defense, the Chairman of National Security
Resources Board, the Director of Central Intelligence, and the National Secur-
ity Council, acting through its Executive Secretary, are authorized to appoint
such advisory committees and to employ, consistent with other provisions of
this Act, such part-time advisory personnel as they may deem necessary in
carrying out their respective functions and the functions of agencies under
their control. Persons holding other offices or positions under the United States
for which they receive compensation, while serving as members of such com-
mittees, shall receive no additional compensation for such service. Other mem-
bers of such committees and other part-time advisory personnel so employed
may serve without compensation or may receive compensation at a rate not to
exceed $50 for each day of service, as determined by the appointing authority.
(b) Service of an individual as a member of any such advisory committee,
or in any other part-time capacity for a department or agency hereunder,
shall not be considered as service bringing such individual within the provi-
sions of sections 109 or 113 of the Criminal Code (U. S. C., 1940 edition, title
18, sees. 198 and 203) or section 19 (e) of the Contract Settlement Act of 1944,
unless the act of such individual, which by such section is made unlawful when
performed by an individual referred to in such section, is with respect to any
particular matter which directly involves a department or agency which such
person is advising or in which such department or agency is directly interested.
[p. 9]
1.14a(3) CONGRESSIONAL RECORD
1.14a (3) (a) VOL. 97 (1951), Aug. 2: Passed House, pp. 9431-
9433
ARMED SERVICES RESEARCH AND
DEVELOPMENT WORK
Mr. SABATH. Mr. Speaker. I call
up House Resolution 358 and ask for
its immediate consideration.
The Clerk read as follows:
Resolved, That immediately upon the adoption
of this resolution it shall be in order to move
that the House resolve itself into the Committee
of the Whole House on the State of the Union
for the consideration of the bill (H. R. 1180) to
facilitate the performance of research and de-
velopment work by and on behalf of the Depart-
ments of the Army, the Navy, and the Air
Force, and for other purposes. That after
general debate, which shall be confined to the
bill and continue not to exceed 1 hour, to be
equally divided and controlled by the chairman
and ranking minority member of the Committee
on Armed Services, the bill shall be be read for
amendment under the 5-minute rule. At the
conclusion of the consideration of the bill for
amendment, the Committee shall rise and report
the bill to the House with such amendments as
may have been adopted and the previous question
shall be considered as ordered on the bill and
amendments thereto to final passage without
intervening motion except one motion to re-
commit.
Mr. SABATH. Mr. Speaker, House
Resolution 358 makes in order the bill
(H. R. 1180) to facilitate the perform-
ance of research and development work
by and on behalf of the Department of
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STATUTES AND LEGISLATIVE HISTORY
1205
the Army, the Navy, and the Air Force.
The bill was unanimously reported
from the great Committee on Armed
Services, and its very able and efficient
chairman the gentleman from Georgia
[Mr. VINSON] so thoroughly convinced
the membership of my Committee on
Rules that it, too, voted to report this
rule unanimously. And while there is 1
hour of debate allowed on this rule, I
feel certain it will not be utilized. As
for myself, realizing that Members
have so many important matters to
attend to, I shall not detain them.
Mr. Speaker, I yield 30 minutes to the
gentleman from Ohio [Mr. BROWN],
a member of the Committee on Rules,
and reserve the balance of my time.
Mr. BROWN of Ohio. Mr. Speaker,
I yield 5 minutes to the gentleman
from Nebraska [Mr. MILLER].
Mr. MILLER of Nebraska. Mr.
Speaker, the bill we have before us now
is important. I am sorry it is called
up at a time when we have so few
Members present, because it is of suffi-
cient importance that we ought to have
a thorough look at its contents. I am
going to support the bill. I do want to
point out that the bill does set up and
let each one of the Secretaries in the
departments have their own advisory
committees as far as scientific develop-
ments are concerned. Each Secretary
shall appoint an advisory committee.
There is no limit to the number of com-
mittees ; there is no limit to the number
of $50-a-day men they may put on the
payroll. I was under the impression
that we had unification of the armed
services. I have been under that im-
pression for some time.
Mr. SABATH. Mr. Speaker, will the
gentleman yield?
Mr. MILLER of Nebraska. I yield to
the gentleman from Illinois.
Mr. SABATH. The members of these
advisory committees will not be on the
payroll. They will be allowed so much
per day when they are called upon to
perform duties.
Mr. MILLER of Nebraska. Yes; let
me quote from the bill:
Each of the Secretaries of the military de-
partments is hereby authorized to establish such
advisory committees or panels as may be neces-
sary for the conduct of the research and devel-
opment activities of his department.
And on page 2 it says that they may
be paid up to $50 for each day of serv-
ice, as determined by the appointing
authority.
I submit to you if we are going to
have unification we do not need three
separate advisory committees, one for
each Secretary, with a large group of
people, we do not know how many there
will be, at $50 a day advising upon sci-
entific matters.
I am willing to support this bill, but
I want to point these things out. I think
it is bad procedure. If we are going to
have unification of the armed services
we ought to say that there shall be one
advisory committee on scientific re-
search. Of course, no advance is ever
made in the country unless we do have
research and examination of things.
After all, research is nothing more than
inquiring and asking questions of the
unknown and seeking the answers. But
here we are making it possible for the
three Secretaries of the Armed Forces
to use specialists and all working along
the same lines without coordination.
In my own memory I do not know of
any great scientific advance that has
been made by the Government, cer-
tainly not in medicine and in any sci-
entific field in which I am acquainted.
The Government itself has never made
one contribution to society in that re-
spect and I doubt very much if they
have in the military field. Your great
advance in medicine comes in scientific
performance when freemen with free
minds can go out and explore into the
unknown, find and come up with the
answer. That is where the progress has
been made. When freemen become fet-
tered by Government regulations, as I
am afraid they will under this bill, no
progress is made. I think you have to
have some scientific men, but you have
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1206
LEGAL COMPILATION—PESTICIDES
to take them from private life, not
from Government. Of course, these
men who are on the Government pay-
roll do not get extra pay. However, I
am sure that advance in science, and
scientific attainment, under this type
of bill will come from industry, not by
Government effort. It has always been
true that every time the Government
lays its cold and clammy hand on scien-
tific development then progress stops.
[p. 9431]
The great advance in the past comes
with the minimum of interference by
the Government. The scientific mind
does not perform when restricted by
red tape.
I realize there are other things in
the bill besides the matter of the ap-
pointment or the establishment of ad-
visory committees, and I have no objec-
tion to them. I do hope that when the
bill is adopted perhaps these three
Secretaries can get together and will
not have three advisory committees
and a lot of people on the payroll at
$50 a day doing the same work. Do we
have unification of the Armed Forces
when you permit the three Secretaries,
and probably we will have a fourth in
the Marine Corps set-up, having ad-
visory committees doing the same
work? There ought to be unity and a
complete exchange of ideas. Right now
in Washington—England, Canada,
France and the United States are try-
ing to standardize their small arms.
That is all to the good.
I would like this bill better if all the
Secretaries had their scientific commit-
tees under one umbrella and their work
coordinated—it would save the taxpay-
ers money.
Mr. BROWN of Ohio. Mr. Speaker, I
yield 1 minute to the gentleman from
Illinois [Mr. ABENDS] .
Mr. ABENDS. Mr. Speaker, I take
this time for the purpose of inquiring
of the majority leader if he can at this
time inform the House as to the pro-
gram for next week.
Mr. McCORMACK. I will be glad to.
On Monday we will take up the Con-
sent Calendar. There will also be two
suspensions. One is H. R. 4288, inter-
state compacts, Texas and Louisiana,
and the other is H. R. 3830, geomag-
netic station construction. I understand
that that bill would have been con-
sidered by unanimous consent except
for the fact that it slightly exceeded
the amount that the screening com-
mittee felt should not be passed by
unanimous consent.
On Tuesday there will be the call of
the Private Calendar.
Wednesday, and for the remainder
of the week, we will take up the De-
partment of Defense appropriation
bill, 1952.
There are primaries in Mississippi
and Virginia on Tuesday, and of
course, we have an understanding that
on those days no roll calls will be had.
The only business on that day will be
the call of the Private Calendar.
Conference reports, of course, may
be brought up at any time, but none
will be brought up on Monday or Tues-
day. I make that statement so that
the Members of the House can govern
themselves accordingly.
Any further program or change in
program, of course, for next week,
will be announced as soon as possible
later on.
Mr. ARENDS. Is it the hope to finish
the Department of Defense appropria-
tion bill next week?
Mr. McCORMACK. Oh, yes, because
the week after next we expect to have
the ECA authorization bill up. With
the Department of Defense appropria-
tion bill and the ECA appropriation
bill, which ought to follow quickly, out
of the way, daylight can be seen for
some 3-day recesses. I do not know how
many, and I cannot make any prom-
ises, but I have been driving for it since
last January.
Mr. ARENDS. That is the best ray
of sunshine I have had for a long time,
and I think that goes for all the Mem-
bers.
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STATUTES AND LEGISLATIVE HISTORY
1207
Mr. McCORMACK. I thank the gen-
tleman.
Mr. SABATH. Mr. Speaker, I move
the previous question on the resolution.
The previous question was ordered.
The resolution was agreed to.
Mr. BROOKS. Mr. Speaker, there is
no opposition to this bill, so I ask unan-
imous consent that we waive the terms
of the resolution requiring us to go into
the Committee of the Whole House on
the State of the Union and that in lieu
thereof the bill be printed at this point,
and be considered in the House under
the 5-minute rule.
The Clerk read the title of the bill.
The SPEAKER pro tempore (Mr.
KELLEY of Pennsylvania). Is there ob-
jection to the request of the gentleman
from Louisiana?
There was no objection.
The bill is as follows :
Be it enacted, etc.. That each of the Secre-
taries of the military departments is hereby
authorized to establish such advisory committees
or panels as may be necessary for the conduct
of the research and development activities of
his department, and to employ such part-time
advisory personnel as they may deem necessary
in carrying: out such activities. Persons holding
other offices or positions under the United States
for which they receive compensation, while
serving as members of such committees, shall
receive no additional compensation for such
service. Other members of such committees and
other part-time advisory personnel so employed
may serve without compensation or may receive
compensation at a rate not to exceed $50 for
each day of service, as determined by the
appointing authority.
Service of an individual as a member of any
such advisory committee, or in any other part-
time capacity for a department hereunder, shall
not be considered as service bringing such indi-
vidual within the provisions of sections 281, 283,
or 284 of title 18, United States Code, unless the
act of such individual, which by such section is
made unlawful when performed by an individual
referred to in such section, is with respect to any
particular matter which directly involves a
department which such person is advising or in
which such department is directly interested.
The provisions of the act of July 12, 1870
(Revised Statutes, 3679), as amended, shall not
apply to the acceptance of voluntary service of
any member of any committee or panel author-
ized by this section.
SEC. 2. No provision of law prohibiting em-
ployment of or payment of compensation or
expenses to any person not a citizen of the
United States shall apply to any expert, sci-
entific, technical, or professional person whose
appointment or employment in connection with
the research and development activities of the
military departments is determined by the
Secretary concerned to be necessary.
SEC. 3. Contracts of the military departments
for services and use of facilities for research
or development may be made for a term not to
exceed 6 years, and may be extended for an
additional period not to exceed 5 years, subject
to the availability of appropriations therefor.
SEC. 4. Any contract to the military depart-
ments for research or development, or both,
may provide for the acquisition or construction
by, or furnishing to, the contractor of such
research, developmental, or test facilities and
equipment as may be determined by the Secre-
tary concerned to be necessary for the per-
formance thereof. Such research, developmental,
or test facilities and equipment, including spe-
cialized housing therefor, may be acquired or
constructed at Government expense, and may
be furnished to the contractor by lease, loan, or
sale at fair value, and with or without reim-
bursement to the Government for the use
thereof: Provided, That nothing contained in
this subsection shall be deemed to authorize new
construction or improvements having general
utility: Provided further, That nothing con-
tained herein shall be deemed to authorize the
installation or construction of facilities on
property not owned by the Government which
would not be readily removable or separable
without unreasonable expense or unreasonable
loss of value, unless adequate provision is made
in the contract for (1) reimbursement to the
Government of the fair value of such facilities
upon the completion or termination of the con-
tract, or within a reasonable time thereafter, or
(2) an option in the Government to acquire
the underlying land, or (3) such other provisions
as will in the opinion of the Secretary concerned
be adequate to protect the Government's interest
in such facilities: And provided further. That
all moneys arising from sales or reimbursement
under this section shall be covered into the
Treasury as miscellaneous receipts, except to
the extent otherwise authorized by law with
respect to contractor-acquired property.
SEC. 5. With the approval of the Secretary
concerned, any contract of the military depart-
ments for research or development, or both,
may provide that the Government will indem-
nify the contractor against either or both of
the following to the extent that they arise out
of the direct performance of said contract and
are not compensated by insurance or otherwise:
(1) Liability on account of claims (including
reasonable expenses of litigation or settlement
of such claims) by third persons, including em-
ployees of the contractor, for death, bodily
injury, or loss of or damage to property, arising
as a result of a risk denned in the contract to
be unusually hazardous: Provided, That any
contract so providing shall also contain appro-
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1208
LEGAL COMPILATION—PESTICIDES
priate provisions for notice to the Government
of suits or actions filed or claims made, against
the contractor, with respect to any alleged
liability for such death, bodily injury, or loss
of or damage to property, and for control of or
assistance in the defense of any such suit,
action, or claims, by the Government, at its
election; and (2) loss of or damage to property
of the contractor arising as a result of a risk
defined in the contract to be unusually haz-
ardous; And provided further. That no payment
shall be made by the Government under author-
ity of this section unless the amount thereof
shall first have been certified to be just and
reasonable by the Secretary concerned or by an
official of the department designated for such
purpose by the Secretary. Any such payment
may be made, with the approval of the Secretary
concerned, out of any funds, obligated for the
performance of auch contract or out of funds
available for research and development work
and not otherwise obligated: or out of any
funds appropriated by the Congress for the
making of such payments.
SEC. 6. Each of the Secretaries of the military
department is authorized to prescribe, with the
approval of the Secretary of Defense and of the
Comptroller General of the United States, regu-
lations for his department stating the extent
to which vouchers for funds expended under
any contract for research or development, or
both, shall be subject to itemization, substantia-
[p. 9432]
tion, or certification prior to payment, without
regard to the limitations of other laws relating
to the expenditure of public funds and account-
ing therefor.
SEC. 7. Each of the Secretaries of the military
departments is authorized to arrange for the
publication of scientific and technical informa-
tion resulting from the research and develop-
ment activities of his department, eo as to
further the full dissemination of information of
scientific value consistent with the national
interest without regard to the provisions of sec-
tion 87 of the act of January 12, 1895 (28 Stat.
662), as amended, or of section 2 of the act of
June 30, 1906 (34 Stat. 762), as amended.
SBC. 8. Each of the Secretaries of the military
departments is authorized to delegate any au-
thority provided by this act to the Under Secre-
tary or any Assistant Secretary of his depart-
ment and, except the authority under the
second proviso in section 4 hereof, the said
Secretaries may delegate any authority provided
by this act to the chiefs of the technical
services, bureaus, or offices and to one assistant
to each such chief. The power to negotiate,
execute, and administer contracts for research
or development, or both, may be further dele-
gated, subject to the provisions of any other
applicable law.
Mr. HEBERT. Mr. Speaker, I move
to strike out the last word.
Mr. Speaker, this bill is designed to
coordinate and unify the efforts of the
Department of Defense in the field of
research and development. It does four
particular and important things: First
of all, it gives to the several Secretar-
ies of the Department of Defense the
Power and the legal right to employ
any individual skilled in the particular
field of science in which there is a de-
sired development.
In answer to the distinguished gen-
tleman from Nebraska, this bill accom-
plishes exactly and definitely what he
obviously misunderstands in his read-
ing of it. It means that the greatest
scientists in any field, without limita-
tion, can be employed as advisers by
the Department of Defense in the de-
velopment of that specific science. I
think that is what the gentleman ob-
jected to.
Mr. MILLER of Nebraska. No, I am
not objecting to that at all. I think that
is a very fine part of the bill. The gen-
tleman said in his opening statement
that it was designed to unify the de-
partments. I claim that when you have
three Secretaries, each one with the
right and power and authority to es-
tablish advisory committees or panels,
and to set up advisory boards, there is
no unification, even though you may
say there is. When you have three men
doing the same work, setting up the
same panels, hiring the same experts,
then I claim that that is not unification
of the armed forces. I wish it were.
Does the gentleman think it is? You
have three bosses. How can you do it?
Mr. HEBERT. What this bill does
is to write into law that which is al-
ready the practice under the Unifica-
tion Act. Let the gentleman not confuse
himself in the idea that these three
Secretaries will be duplicating their
efforts. It means that the three Secre-
taries are able to obtain the services
of the highest scientific skill known in
this country, or foreign assistance, if
necessary, and they are able to get it,
to develop the weapons necessary for
-------
STATUTES AND LEGISLATIVE HISTORY
1209
each individual branch of the service.
By the farthest stretch of the imagina-
tion the Secretary of the Navy could
not be expected to draw on a scientist
in a field that is related to the Army or
the Air Force or the development of
airplanes if he wanted to find out
something about a battleship. This bill
allows the Secretaries of the Army, the
Air Force, and the Navy to employ the
specific specialists and experts and sci-
entists in their particular fields. There
is absolutely no duplication of effort.
On the contrary, there is a concentra-
tion and a unification of effort.
Mr. MILLER of Nebraska. I happen
to have some information and knowl-
edge about the so-called ABC program
of the Defense Department, that is,
the Atomic Energy, Bacterial, and
Chemical Warfare Division. Under
this each Secretary has a division
working with that same lethal weapon,
which I think is absolutely necessary.
But I am very fearful, in fact, I know
they are not coordinating their work. I
raise the question that if you are going
to have unification there ought to be
some coordination of that one particu-
lar field. We can go into the field of
medicine and cover the whole gauntlet.
Men who are working in the Navy, the
Air Force, and the Army tell me there
is no coordination in their bone graft-
ing, blood transfusions, and other tech-
nical things where there should be
absolute coordination of the work. Here
you are saying to the three Secretaries,
"Set up your own division, your own
division board, and go your own way."
I would like to see just what the gentle-
man has mentioned, unification where
you can bring these scientists all to-
gether under one tent, and not under
three bosses.
Mr. HEBERT. In reply to the gen-
tleman from Nebraska may I point out
the fact that I had the privilege of be-
ing present at the Eniwetok atomic
experiments, and I have never seen
such unification, such coordination,
such cooperation, and such unity of
purpose as I saw at Eniwetok between
the three branches of the services, and
added to that the inclusion of the civil-
ian branch.
Mr. MILLER of Nebraska. I think
that is true. I am glad to know it. But
I would feel much better if we would
say that the Secretary of Defense,
under whom these Secretaries work,
might have the authority to set up an
advisory committee, which he is al-
ready doing and should do, in which he
could pool all of these scientists under
one tent, under one umbrella, instead
of having three sets, as I know they are
doing today, going many times in oppo-
site directions and not coordinating
their work. That is the thing I objected
to. I think it is not in the interest of
the public.
Mr. HEBERT. I feel certain this bill
will tend toward accomplishing the
purpose which both the gentleman and
I have in common. I am confident of it.
The bill also provides that the De-
partment of Defense shall be allowed
to enter into long-term contracts in the
field of research and development. The
necessity for this becomes obvious
when we realize that so many of the
contracts in this field cannot be ter-
minated in a short time and it is neces-
sary that they be spread over a longer
period. In addition, the bill also pro-
vides that the Department of Defense
shall be empowered to employ the serv-
ices of other than citizens of the United
States. I think it is generally recog-
nized that some of the great scientists
of this age and day come from other
countries. This bill allows them to come
into the Department of Defense in re-
search and development, The most im-
portant feature of the bill is that
section which in effect indemnifies
private contractors who are contracted
to the Government to conduct these ex-
perimental features. I may point out
the necessity for this is pointed up
perhaps in the development of the
supersonic plane by the Bell Airplane
Co. In that particular instance it was
-------
1210
LEGAL COMPILATION—PESTICIDES
impossible to indemnify a civilian test
pilot, and an Army lieutenant was used
to fly that ship on its first flight.
Mr. BROOKS. Mr. Speaker, will the
gentleman yield?
Mr. HEBERT. I yield.
Mr. BROOKS. I compliment the gen-
tleman for doing a great job here in
handling this bill and having it ap-
proved and brought to the House. It is
an extremely important bill. I recall in
the testimony it was stated that the
authority to use scientists is presently
in the law. What is wanted now is the
authority to use them in committees.
They told us at the time this was con-
sidered that this would not result in
the employment of one single addi-
tional individual. That is correct, is it
not?
Mr. HEBERT. That is correct. The
bill indicates no additional employment
of individuals and no additional appro-
priations. It is merely unifying and
codifying the law in connection with
present practices. There is no indicated
expansion of personnel.
Mr. BROOKS. I am impressed very
much with the authority given under
this bill to enter into long-term or long-
range contracts for experimental work.
In my judgment it will not only bring
about greater results but will result in
greater efficiency and at far less cost
to the Government. If anything, I
would call this bill a bill to save money
and render more efficient service in re-
search work. That is true, is it not?
Mr. HEBERT. The gentleman's in-
terpretation of the bill is correct. This
is a bill that unties the hands of the
departments and expands them in the
field of research and development
which is so essential and necessary in
this age of scientific warfare. It be-
comes very important that the Depart-
ment of Defense be allowed without
interference and without any hand-
tying to continue to develop our weap-
ons of war in the scientific field. Of
course, No. 1 is the atomic bomb, re-
coilless weapons and infrarays used in
the front lines, and many many other
weapons now on the drawing boards
and in the scientific laboratories.
The SPEAKER. The time of the
gentleman has expired.
The bill was ordered to be engrossed
and read a third time, was read the
third time, and passed, and a motion to
reconsider was laid on the table.
[p. 9433]
1.14a(3)(b) VOL. 98 (1952), July 3: Amended and passed Senate,
pp. 9053-9054
FACILITATION OF RESEARCH
AND DEVELOPMENT WORK BY
DEPARTMENTS OF ARMY,
NAVY, AND AIR FORCE
The bill (H. R. 1180) to facilitate
the performance of research and de-
velopment work by and on behalf of the
Departments of the Army, the Navy,
and the Air Force, and for other pur-
poses was announced as next in order.
Mr. MORSE. Mr. President, I should
like to make a brief statement on this
bill.
The VICE PRESIDENT. Is the Sen-
ator reserving the right to object?
Mr. MORSE. I reserve the right to
object.
Mr. President, I make this statement
in behalf of the Armed Services Com-
mittee: The Senator from Kansas [Mr.
SCHOEPPEL] has prepared several
amendments to House bill 1180 dealing
with research and development work.
These amendments are restrictive in
nature. However, in examining them,
we feel that that there is no reason they
should not be accepted by the commit-
tee and by the Senate, so that the bill
may be passed.
I want to make it clear that we have
gone into this matter with the assist-
ance of the professional staff of the
Armed Services Committee, and I think
-------
STATUTES AND LEGISLATIVE HISTORY
1211
the amendments of the Senator from
[p. 9053]
Kansas should be adopted. I hope he
will offer them and that there will be
no objection to them.
The VICE PRESIDENT. The ques-
tion is, Is there objection to the consid-
eration of the bill?
There being no objection, the Senate
proceeded to consider the bill.
Mr. SCHOEPPEL. Mr. President, I
call up amendment A, amendment B,
and amendment C which were sent to
the desk a few days ago, and which I
understand are printed.
The VICE PRESIDENT. Does the
Senator wish to have them considered
en bloc?
Mr. SCHOEPPEL. Yes, Mr. Presi-
dent.
The VICE PRESIDENT. The clerk
will state the amendments offered by
the Senator from Kansas.
Mr. HAYDEN. Mr. President, may
I ask the Senator from Kansas if one
of those amendments is to strike out
section 7?
Mr. SCHOEPPEL. Amendment C
does that.
Mr. HAYDEN. That section should
be eliminated, because it interferes
with the jurisdiction of the Joint Com-
mittee on Printing.
Mr. SCHOEPPEL. That was the
view of the Senator from Kansas.
The VICE PRESIDENT. The clerk
will state the amendments offered by
the Senator from Kansas.
The amendments were:
On page 2, strike out all in lines 7 to 20,
inclusive.
On page 4. line 12, after the period, insert the
following: "The Secretary of each of the mili-
tary departments shall transmit to the Congress
reports covering contracts for research or
development entered into during each 6 months
following the enactment of this act. Each euch
report shall contain (1) a list of each contract
for research or development entered into during
such period the total cost of which to the Gov-
ernment will exceed $50,000, and (2) specific
information with respect to each such contract,
except that specific information the disclosure
of which he deems incompatible with the secur-
ity of the United States may be excluded from
such reports."
On page 6, strike out all in lines 4 to 12,
inclusive.
On page 6, line 13, strike out the section No.
"8" and insert in lieu thereof the section No.
"7."
Mr. SCHOEPPEL. Mr. President,
with reference to amendment A, under
section 1 of the bill members of com-
mittees and panels and advisory per-
sonnel could be exempted from the so-
called conflict of interest provisions of
title 18, United States Code, relating
to Federal officers and employees. The
amendment A would strike this provi-
sion from the bill.
Amendment B would require that re-
ports be made to Committees on Ap-
propriations and Armed Services of
the Senate and of the House of Repre-
sentatives every 6 months by the Secre-
tary of each of the Military Depart-
ments, listing all contracts for research
and development in excess of $50,000.
Such reports shall contain specific in-
formation with respect to any such
contract. Provision is made, however,
for the exclusion in such reports of
specific information pertaining to such
contracts which is deemed by the Sec-
retary to be incompatible with the se-
curity of the United States.
Amendment C would eliminate from
this bill authority to waive certain ex-
isting requirements of law with regard
to printing in the case of publication of
scientific and technical information.
The VICE PRESIDENT. The ques-
tion is on agreeing en bloc to the
amendments offered by the Senator
from Kansas.
The amendments were agreed to.
The amendments were ordered to be
engrossed and the bill to be read a
third time.
The bill was read the third time and
passed.
[p.9054]
-------
1212
LEGAL COMPILATION—PESTICIDES
1.14a(3)(c) VOL. 98 (1952), July 4: House concurs in Senate
amendments, pp. 9374-9375
RESEARCH AND DEVELOPMENT restrictive in nature and while the De-
WORK partment would normally not want to
agree to those amendments, the time
element at present has prompted them
to state that the House should agree to
the amendments.
Section 1 of the House bill relieved
the members of the committees of civil-
ians, which committees were to assist
each of the service Secretaries on cer-
tain statutory restrictions. For in-
stance, the members of these commit-
tees would be permitted to serve with
or without compensation and would be
exempted from certain statutory pro-
hibitions and penalties which are ap-
plicable to all other Federal employees,
for example, in regard to the partici-
pation in Government contracts or
claims against the Government. The
net result of the Senate amendment
would be that persons who comprise
these advisory panels to the Secre-
taries will probably have to be picked
from sources which are not in a con-
tractual relationship with the Govern-
ment.
The second amendment requires each
of the Secretaries to report on research
and development contracts involving
more than $50,000 each 6 months, un-
less publication of the information
would violate security considerations.
The third amendment deletes section
7 of the bill which authorized the Sec-
retaries of the military departments to
arrange for the publication of scien-
tific and technical information result-
ing from the research and development
activities of his Department.
The author of the Senate amend-
ment, Senator SCHOEPPEL, is of the
opinion that this printing can be taken
care of in a different fashion.
Mr. ABENDS. Mr. Speaker, I with-
draw my reservation of objection.
The SPEAKER. Is there objection
to the request of the gentleman from
Georgia [Mr. VINSON]?
Mr. VINSON. Mr. Speaker, I ask
unanimous consent to take from the
Speaker's table the bill (H. R. 1180) to
facilitate the performance of research
and development work by and on be-
half of the Departments of the Army,
the Navy, and the Air Force, and for
other purposes, with Senate amend-
ments thereto, and concur in the Sen-
ate amendments.
The Clerk read the title of the bill.
The Clerk read the Senate amend-
ments, as follows:
Page 2, strike out lines 7 to 20, inclusive.
Page 4, line 12, after "property", insert "The
Secretary of each of the military departments
shall transmit to the Congress reports covering
contracts for research or development entered
into during each 6 months following the enact-
ment of this act. Each such report shall contain
(1) a list of each contract for research or devel-
opment entered into during such period the total
cost of which to the Government will exceed
$50,000, and (2) specific information with
respect to each such contract, except that spe-
cific information the disclosure of which he
deems incompatible with the security of the
United States may be excluded from euch
reports."
Page 6, strike out lines 8 to 16, inclusive.
Page 6, line 17, strike out "8" and insert "7."
The SPEAKER. Is there objection
to the request of the gentleman from
Georgia?
Mr. ARENDS. Mr. Speaker, reserv-
ing the right to object, I do so only for
[p. 9374]
the purpose of asking the chairman of
the Committee on Armed Services to
explain to the House these three
changes which were made by the other
body and agreed to by the conferees.
Mr. VINSON. Mr. Speaker, H. R.
1180 is a bill to facilitate the perform-
ance of research and development work
by the Army, Navy, and Air Force,
passed the House on August 2,1951. It
passed the Senate on July 3,1952, with
three amendments.
The three Senate amendments are
-------
STATUTES AND LEGISLATIVE HISTORY
1213
There was no objection.
The Senate amendments were con-
curred in.
A motion to reconsider was laid on
the table.
[p.9375]
1.14b ARMED FORCES PROCUREMENT AMENDMENTS OF
1956
August 10,1956, P.L. 84-1028, §§2353, 2354, 70A Stat. 134
§ 2353. Contracts: acquisition, construction, or furnishing of test
facilities and equipment
(a) A contract of a military department for reasearch or de-
velopment, or both, may provide for the acquisition or construction
by, or furnishing to, the contractor, of research, developmental, or
test facilities and equipment that the Secretary of the military
department concerned determines to be necessary for the perform-
ance of the contract. The facilities and equipment, and specialized
housing for them, may be acquired or constructed at the expense of
the United States, and may be lent or leased to the contractor with
or without reimbursement, or may be sold to him at fair value. This
subsection does not authorize new construction or improvements
having general utility.
(b) Facilities that would not be readily removable or separable
without unreasonable expense or unreasonable loss of value may
not be installed or constructed under this section on property not
owned by the United States, unless the contract contains—
(1) a provision for reimbursing the United States for the
fair value of the facilities at the completion or termination of
the contract or within a reasonable time thereafter;
(2) an option in the United States to acquire the underly-
ing land; or
(3) an alternative provision that the Secretary concerned
considers to be adequate to protect the interests of the United
States in the facilities.
(c) Proceeds of sales or reimbursement under this section shall
be paid into the Treasury as miscellaneous receipts, except to the
extent otherwise authorized by law with respect to property ac-
quired by the contractor.
§ 2354. Contracts: indemnification provisions
(a) With the approval of the Secretary of the military depart-
ment concerned, any contract of a military department for research
or development, or both, may provide that the United States will
indemnify the contractor against either or both of the following,
but only to the extent that they arise out of the direct performance
-------
1214 LEGAL COMPILATION—PESTICIDES
of the contract and to the extent not compensated by insurance or
otherwise:
(1) Claims (including reasonable expenses of litigation or
settlement) by third persons, including employees of the con-
tractor, for death, bodily injury, or loss of or damage to prop-
erty, from a risk that the contract defines as unusually haz-
ardous.
(2) Loss of or damage to property of the contractor from
a risk that the contract defines as unusually hazardous.
(b) A contract, made under subsection (a), that provides for
indemnification must also provide for—
(1) notice to the United States of any claim or suit against
the contractor for the death, bodily injury, or loss of or dam-
age to property; and
(2) control of or assistance in the defense by the United
States, at its election, of that suit or claim.
(c) No payment may be made under subsection (a) unless the
Secretary of the department concerned, or an officer or official of
his department designated by him, certifies that the amount is just
and reasonable. [p. 134]
(d) Upon approval by the Secretary concerned, payments under
subsection (a) may be made from—
(1) funds obligated for the performance of the contract
concerned;
(2) funds available for research or development, or both,
and not otherwise obligated; or
(3) funds appropriated for those payments. r 1QK,
Lp. looj
1.14b(l) HOUSE COMMITTEE ON THE JUDICIARY
H.R. REP. No. 970,84tti Cong., 1st Sess. (1955)
REVISION OF TITLE 10, U. S. CODE, ENTITLED "ARMED
FORCES", AND TITLE 32, U. S. CODE, ENTITLED
"NATIONAL GUARD"
JUNE 28,1955.—Committed to the Committee of the Whole House on the State
of the Union ordered to be printed
Mr. WILLIS, from the Committee on the Judiciary, submitted the
following
REPORT
[To accompany H.R. 7049]
The Committee on the Judiciary, to whom was referred the bill
(H.R. 7049) to revise, codify, and enact into law title 10 of the
-------
STATUTES AND LEGISLATIVE HISTORY
1215
United States Code, entitled "Armed Forces", and title 32, United
States Code, entitled "National Guard", having considered the
same, report favorably thereon and recommend that the bill do
pass. [pl]
2.SCOPE
In general, the new title 10, Armed Forces, and the new title 32,
National Guard, codify the statutory provisions heretofore reflect-
ed in titles 10, 32, and 34, and chapters 3, 7, and 11B of title 5, of
the United States Code. All provisions within these areas have
been accounted for (see Table 2), whether or not they are codified
in the new titles. However, logic and consistency require the exclu-
sion of some laws now codified in the titles and chapters just men-
tioned, and the inclusion of others now codified elsewhere. Laws of
this kind have been accounted for only if included (see Table 2).
[P. 5]
SECTION 2353
Source
' Code>
2353 (a) 5:235e (1st sentence; and
2d sentence, less 2d and
last provisos)
5:475j (1st sentence; and
2d sentence, less 2d and
last provisos)
5:628e (1st sentence; and
2d sentence, less 2d and
last provisos)
2353 (b) 5:235e (2d proviso of 2d
sentence)
5:475j (2d proviso of 2d
sentence)
5:628e (2d proviso of 2d
sentence)
2353 (c) 5:235e (last proviso of 2d
sentence)
5:475j (last proviso of 2d
sentence)
5:628e (last proviso of 2d
sentence)
In subsection (a), the words "furnished to" and "for the use
thereof" are omitted as surplusage.
In subsections (a) and (b), the words "United States" are sub-
stituted for the word "Government".
In subsection (b), the introductory clause is substituted for
5:235e (words of 2d proviso before clause (1)), 475j, and 628e.
Source (Statutes at Large)
July 16,1952, ch. 882, § 4 (less 3d
and last sentences), 66 Stat. 725.
-------
1216
LEGAL COMPILATION—PESTICIDES
The words "that. . . considers" are substituted for the words "as
will in the opinion". The words "an alternative" are substituted for
the words "such other".
In subsection (c), the words "Proceeds of" are substituted for
the words "That all moneys arising from".
Revised
Section Source
-------
STATUTES AND LEGISLATIVE HISTORY
1217
1.14b (2) SENATE COMMITTEE ON THE JUDICIARY
S. REP. No. 2484, 84th Cong., 2d Sess. (1956)
REVISION OF TITLE 10, UNITED STATES CODE, ENTITLED
"ARMED FORCES", AND TITLE 32, UNITED STATES CODE,
ENTITLED "NATIONAL GUARD"
JULY 9,1956.—Ordered to be printed
Mr. O'MAHONEY, from the Committee on the Judiciary, submitted
the following
REPORT
[To accompany H.R. 7049]
The Committee on the Judiciary, to which was referred the bill
(H.R. 7049) to revise, codify, and enact into law title 10 of the
United States Code, entitled "Armed Forces", and title 32 of the
United States Code, entitled "National Guard", having considered
the same, reports favorably thereon with amendments and recom-
mends that the bill, as amended, do pass.
Revised
Section
2353 (a)
Source (U. S. Code)
2353 (b)
2353 (c)
5:235e (1st sentence; and
2d sentence, less 2d and
last provisos)
5:475j (1st sentence; and
2d sentence, less 2d and
last provisos)
5:628e (1st sentence; and
2d sentence, less 2d and
last provisos)
5:235e (2d proviso of 2d
sentence)
5:475j (2d proviso of 2d
sentence)
5:628e (2d proviso of 2d
sentence)
5:235e (last proviso of 2d
sentence
5:475j (last proviso of 2d
sentence
5:628e (last proviso of 2d
sentence
SECTION 2353
Source (Statutes at Large)
July 16,1952, ch. 882, § 4 (less 3d and
last sentences), 66 Stat. 725.
-------
1218
LEGAL COMPILATION—PESTICIDES
In subsection (a), the words "furnished to" and "for the use
thereof" are omitted as surplusage.
In subsections (a) and (b), the words "United States" are sub-
stituted for the word "Government".
In subsection (b), the introductory clause is substituted for
5:235e (words of 2d proviso before clause (1)), 475j, and 628e.
The words "that. . . considers" are substituted for the words "as
will in the opinion". The words "an alternative" are substituted for
the words "such other".
In subsection (e), the words "Proceeds of" are substituted for
the words "That all moneys arising from".
SECTION 2354
Revised Source (Statutes at Large)
Section Source July is, 1952, ch. 882, § 5, 66 Stat. 726.
2354 (a) 5:235f (1st sentence, less
provisos)
5:475k (1st sentence, less
provisos)
5:628f (1st sentence, less
provisos)
2354 (b) 5:235f (1st proviso of 1st
sentence)
5:475k (1st proviso of 1st
sentence)
5:628f (1st proviso of 1st
sentence)
2354 (c) 5:235f (last proviso of 1st
sentence)
5:475k (last proviso of 1st
sentence)
5:628f (last proviso of 1st
sentence)
2354 (d) 5:235f (less 1st sentence)
5:475k (less 1st sentence)
5:628f (less 1st sentence)
In subsection (a), the words "Liability on account of", and "of
such claims" are omitted as surplusage. In clauses (1) and (2), the
word "from" is substituted for the words "arising as a result of".
[p. 149]
1.14b (3) CONGRESSIONAL RECORD
1.14b(3)(a) VOL. 101 (1955), Aug. 1: Amended and passed
House, pp. 12718-12719
[No Relevant Discussion on Pertinent Section]
-------
STATUTES AND LEGISLATIVE HISTORY 1219
l.Ub (3) (b) VOL. 102 (1956), July 23: Amended and passed
Senate, p. 13953
[No Relevant Discussion on Pertinent Section]
1.14b(3)(c) VOL. 102 (1956), July 25: House concurs in Senate
amendment, p. 14455
[No Relevant Discussion on Pertinent Section]
1.15 RULE MAKING, ADMINISTRATIVE PROCEDURE
AS REVISED
5 U.S.C. §553 (1966)
[Referred to in 15 U.S.C. §1474(a), (b)]
THE ADMINISTRATIVE PROCEDURE ACT
§ 553. Rule making
(a) This section applies, according to the provisions thereof,
except to the extent that there is involved—
(1) a military or foreign affairs function of the United
States; or
(2) a matter relating to agency management or personnel
or to public property, loans, grants, benefits, or contracts.
(b) General notice of proposed rule making shall be published in
the Federal Register, unless persons subject thereto are named and
either personally served or otherwise have actual notice thereof in
accordance with law. The notice shall include—
(1) a statement of the time, place, and nature of public rule
making proceedings;
(2) reference to the legal authority under which the rule is
proposed; and
(3) either the terms or substance of the proposed rule or a
description of the subjects and issues involved.
Except when notice or hearing is required by statute, this subsec-
tion does not apply—
(A) to interpretative rules, general statements of policy, or
rules of agency organization, procedure, or practice; or
(B) when the agency for good cause finds (and incor-
porates the finding and a brief statement of reasons therefore
in the rules issued) that notice and public procedure thereon
are impracticable, unnecessary, or contrary to the public
interest.
(c) After notice required by this section, the agency shall give
interested persons an opportunity to participate in the rule making
through submission of written data, views, or arguments with or
-------
1220 LEGAL COMPILATION—PESTICIDES
without opportunity for oral presentation. After consideration of
the relevant matter presented, the agency shall incorporate in the
rules adopted a concise general statement of their basis and pur-
pose. When rules are required by statute to be made on the record
after opportunity for an agency hearing, sections 556 and 557 of
this title apply instead of this subsection.
(d) The required publication or service of a substantive rule
shall be made not less than 30 days before its effective date,
except—
(1) a substantive rule which grants or recognizes an
exemption or relieves a restriction;
(2) interpretative rules and statements of policy; or
(3) as otherwise provided by the agency for good cause
found and published with the rule.
(e) Each agency shall give an interested person the right to
petition for the issuance, amendment, or repeal of a rule. Pub.L.
89-554, Sept. 6,1966,80 Stat. 383.
1.15a RULE MAKING, JUNE 11,1946, P.L. 97-404, §4,
60 STAT. 238
RULE MAKING
SEC. 4. Except to the extent that there is involved (1) any mil-
itary, naval, or foreign affairs function of the United States or (2)
any matter relating to agency management or personnel or to public
property, loans, grants, benefits, or contracts—
[p. 238]
(a) NOTICE.—General notice of proposed rule making shall be
published in the Federal Register (unless all persons subject there-
to are named and either personally served or otherwise have actual
notice thereof in accordance with law) and shall include (1) a
statement of the time, place, and nature of public rule making pro-
ceedings; (2) reference to the authority under which the rule is
proposed; and (3) either the terms or substance of the proposed
rule or a description of the subjects and issues involved. Except
where notice or hearing is required by statute, this subsection
shall not apply to interpretative rules, general statements of pol-
icy, rules of agency organization, procedure, or practice, or in any
situation in which the agency for good cause finds (and incorpo-
rates the finding and a brief statement of the reasons therefor in
the rules issued) that notice and public procedure thereon are im-
practicable, unnecessary, or contrary to the public interest.
(b) PROCEDURES.—After notice required by this section, the
agency shall afford interested persons an opportunity to partici-
-------
STATUTES AND LEGISLATIVE HISTORY 1221
pate in the rule making through submission of written data, views,
or arguments with or without opportunity to present the same orally
in any manner; and, after consideration of all relevant matter pre-
sented, the agency shall incorporate in any rules adopted a concise
general statement of their basis and purpose. Where rules are re-
quired by statute to be made on the record after opportunity for an
agency hearing, the requirements of sections 7 and 8 shall apply in
place of the provisions of this subsection.
(c) EFFECTIVE DATES.—The required publication or service of
any substantive rule (other than one granting or recognizing ex-
emption or relieving restriction or interpretative rules and state-
ments of policy) shall be made not less than thirty days prior to the
effective date thereof except as otherwise provided by the agency
upon good cause found and published with the rule.
(d) PETITIONS.—Every agency shall accord any interested per-
son the right to petition for the issuance, amendment, or repeal of
a rule.
[p. 239]
1.15a (1) SENATE COMMITTEE ON THE JUDICIARY
S. REP. No. 752, 79th Cong., 1st Sess. (1945)
ADMINISTRATIVE PROCEDURE ACT
NOVEMBER 19 (legislative day, October 29), 1945.—Ordered to be printed
Mr. McCARRAN, from the Committee on the Judiciary,
submitted the following
REPORT
[To accompany S. 7]
The Committee on the Judiciary, to whom was referred the bill
(S. 7), to improve the administration of justice by prescribing fair
administrative procedure, having considered the same, reports
favorably thereon, with an amendment, and recommend that the
bill do pass, as amended.
There is a widespread demand for legislation to settle and regu-
late the field of Federal administrative, law and procedure. The
subject is not expressly mentioned in the Constitution, and there is
no recognizable body of such law, as there is for the courts in the
Judicial Code. There are no clearly recognized legal guides for
either the public or the administrators. Even the ordinary opera-
tions of administrative agencies are often difficult to know. The
Committee on the Judiciary is convinced that, at least in essentials,
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1222 LEGAL COMPILATION—PESTICIDES
there should be some simple and standard plan of administrative
procedure.
I. LEGISLATIVE HISTORY
For more than 10 years Congress has considered proposals for
general statutes respecting administrative law and procedure.
Figure 1 on page 2 presents a convenient chronological chart of the
main bills introduced. Each of them has received widespread notice
and intense consideration.
The growth of the Government, particularly of the executive
branch, has added to the problem. The situation had become such by
the middle of the 1930's that the President appointed a committee
[p.l]
III. STRUCTURE OF THE BILL
The bill, as reported, is not a specification of the details of admin-
istrative procedure, nor is it a codification of administrative law.
Instead, out of long consideration and in the light of the studies
heretofore mentioned, there has been framed an outline of mini-
mum basic essentials. Figure 2 on page 9 diagrams the bill.
The bill is designed to afford parties affected by administrative
powers a means of knowing what their rights are and how they
may be protected. By the same token, administrators are provided
with a simple course to follow in making administrative determin-
ations. The (jurisdiction of the courts is clearly stated. The bill thus
provides for public information, administrative operation, and
judicial review.
SUBSTANCE OF THE BILL.—What the bill does in substance may
be summarized under four headings:
1. It provides that agencies must issue as rules certain
specified information as to their organization and procedure,
and also make available other materials of administrative law
(sec. 3).
2. It states the essentials of the several forms of administra-
tive proceedings (sees. 4, 5, and 6) and the limitations on
administrative powers (sec. 9).
3. It provides in more detail the requirements for admin-
istrative hearings and decisions in cases in which statutes
require such hearings (sees. 7 and 8).
4. It sets forth a simplified statement of judicial review
designed to afford a remedy for every legal wrong (sec. 10).
The first of these is basic, because it requires agencies to take the
initiative in informing the public. In stating the essentials of the
different forms of administrative proceedings, it carefully dis-
tinguishes between the so-called legislative functions of adminis-
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STATUTES AND LEGISLATIVE HISTORY 1223
trative agencies (where they issue general regulations) and their
judicial functions (in which they determine rights or liabilities in
particular cases).
The bill provides quite different procedures for the "legislative"
and "judicial" functions of administrative agencies. In the "rule
making" (that is, "legislative") function it provides that, with
certain exceptions, agencies must publish notice and at least permit
interested parties to submit their views in writing for agency
consideration before issuing general regulations (sec. 4). No
hearings are required by the bill unless statutes already do so in
a particular case. Similarly, in "adjudications" (that is, the
"judicial" function) no agency hearings are required unless
statutes already do so, but in the latter case the mode of hearing
[p. 7]
and decision is prescribed (sec. 5). Where existing statutes require
that either general regulations (called "rules" in the bill) or
particularized adjudications (called "orders" in the bill) be made
after agency hearing or opportunity for such hearing, then
section 7 spells out the minimum requirements for such hearings,
section 8 states how decisions shall be made thereafter, and section
11 provides for examiners to preside at hearings and make or
participate in decisions.
While the administrative power and procedure provisions of sec-
tions 4 through 9 are law apart from court review, the provisions
for judicial review provide parties with a method of enforcing
their rights in a proper case (sec. 10). However, it is expressly
provided that the judicial review provisions are not operative
where statutes otherwise preclude judicial review or where agency
action is by law committed to agency discretion.
KINDS OP PROVISIONS.—The bill may be said to be composed of
five types of provisions:
1. Those which are largely formal such as the sections
setting forth the title (sec. 1), definitions (sec. 2), and rules
of construction (sec. 12).
2. Those which require agencies to publish or make avail-
able information on administrative law and procedure (sec. 3).
3. Those which provide for different kinds of procedures
such as rule making (sec. 4), adjudications (sec. 5), and mis-
cellaneous matters (sec. 6) as well as for limitations upon
sanctions and powers (sec. 9).
4. Those which provide more of the detail for hearings (sec.
7) and decisions (sec. 8) as well as for examiners (sec. 11).
5. Those which provide for judicial review (sec. 10).
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1224 LEGAL COMPILATION—PESTICIDES
The bill is so drafted that its several sections and subordinate
provisions are closely knit. The substantive provisions of the bill
should be read apart from the purely formal provisions and minor
functional distinctions. The definitions in section 2 are important,
but they do not indicate the scope of the bill since the subsequent
provisions make many functional distinctions and exceptions. The
public information provisions of section 3 are of the broadest
application because, while some functions and some operations may
not lend themselves to formal procedure, all administrative opera-
tions should as a matter of policy be disclosed to the public except
as secrecy may obviously be required or only internal agency
"housekeeping" arrangements may be involved. Sections 4 and 5
prescribe the basic requirements for the making of rules and the
adjudication of particular cases. In each case, where other statutes
require opportunity for an agency hearing, sections 7 and 8 set
forth the minimum requirements for such hearings and the agency
decisions thereafter while section 11 provides for the appointment
and tenure of examiners who may participate. Section 6 prescribes
the rights of private parties in a number of miscellaneous respects
which may be incidental to rule making, adjudication, or the exer-
cise of any other agency authority. Section 9 limits sanctions, and
section 10 provides for judicial review. r on
IP- oJ
Section 1 prescribes the title, section 2 the definitions, and section 3 the effective dates and rules
of construction. In the above diagram, the first row of sections sets forth the several kinds of
requirements, procedures, and limitations; and the second row includes hearing and decision re-
quirements where other statutes require a hearing. Section 10 on judicial review relates not only
to decisions made after agency hearing but, in appropriate cases, to the exercise of any other
administrative power or authority.
IV. ANALYSIS OP PROVISIONS
The following statements respecting each provision of the bill
are designed to answer specific questions relating to language and
objectives. Under each section or subsection heading there appears
an italicized synopsis of the provision, followed by one or more
paragraphs of analysis or special comment. A reading of all the
italicized paragraphs will, therefore, afford a synopsis of the whole
bill, which is reproduced at length in appendix A at page 32.
[p. 9]
SBC. 4. RULE MAKING.—The introductory clause exempts from
all of the requirements of section 4 any rule making so far as there
are involved (1) military, naval, or foreign affairs functions or
(2) matters relating to agency management or personnel or to
public property, loans, grants, benefits, or contracts.
-------
STATUTES AND LEGISLATIVE HISTORY 1225
These exceptions would not, of course, relieve any agency from
requirements imposed by other statutes. The phrase "foreign
affairs functions," used here and in some other provisions of the
bill, is not to be loosely interpreted to mean any function extending
beyond the borders of the United States but only those "affairs"
which so affect relations with other governments that, for example,
public rule making provisions would clearly provoke definitely
undesirable international consequences. The exception of matters
of management or personnel would operate only so far as not
inconsistent with other provisions of the bill relating to internal
management or personnel. The exception of proprietary matters is
included because the principal considerations in most such cases
relate to mechanics and interpretations or policy, and it is deemed
wise to encourage and facilitate the issuance of rules by dispensing
with all mandatory procedural requirements. None of these excep-
tions, however, is to be taken as encouraging agencies not to adopt
voluntary public rule making procedures where useful to the
agency or beneficial to the public. The exceptions merely confer a
complete discretion upon agencies to decide what, if any, public rule
making procedures they will adopt in a given situation within their
terms. It should be noted, moreover that the exceptions apply only
"to the extent" that the excepted subjects are directly involved.
(a) NOTICE.—General notice of proposed rule making must be
published in the Federal Register and must include (1) time, place,
[p. 13]
and nature of proceedings, (2) reference to authority under which
held, and (3) terms, substance, or issues involved. However, except
where notice and hearing is required by some other statute, the
subsection does not apply to rules other than those of substance or
where the agency for good cause finds (and incorporates the finding
and reasons therefor in the published rule) that notice and public
procedure are impracticable, unnecessary, or contrary to the pub-
lic interest.
Agenay notice must be sufficient to fairly apprise interested
parties of the issues involved, so that they may present responsive
data or argument relating thereto. The subsection governs the
application of the public procedures required by the next subsec-
tion, since those procedures only apply where notice is required
by this subsection. Agencies are given discretion to dispense with
notice (and consequently with public proceedings) in the case of
interpretative rules, general statements of policy, or rules of
agency organization, procedure, or practice. This does not mean,
however, that agencies should not—where useful to them or help-
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1226 LEGAL COMPILATION—PESTICIDES
ful to the public—undertake public procedures in connection with
such rule making. The exemption of situations of emergency or
necessity is not an "escape clause" in the sense that any agency
has discretion to disregard its terms or the facts. A true and sup-
ported or supportable finding of necessity or emergency must be
made and published. "Impracticable" means a situation in which
the due and required execution of the agency functions would be
unavoidably prevented by its undertaking public rule-making pro-
ceedings. "Unnecessary" means unnecessary so far as the public is
concerned, as would be the case if a minor or merely technical
amendment in which the public is not particularly interested were
involved. "Public interest" supplements the terms "impracticable"
or "unnecessary"; it requires that public rule-making procedures
shall not prevent an agency from operating and that, on the other
hand, lack of public interest in rule making warrants an agency to
dispense with public procedure. It should be noted that where
authority beneficial to the public does not become operative until
a rule is issued, the agency may promulgate the necessary rule
immediately and rely upon supplemental procedures in the nature
of a public reconsideration of the issued rule to satisfy the require-
ments of this section. Where public rule-making procedures are
dispensed with, the provisions of subsection (c) and (d) of this
section would nevertheless apply.
(b) PROCEDURES.—After such notice, the agency must afford
interested persons an opportunity to participate in the rule making
at least to the extent of submitting written data, views, or argu-
ment; and, after consideration of such presentations, the agency
must incorporate in any rules adopted a concise general statement
of their basis and purpose. However, where other statutes require
rules to be made after hearing, the requirements of sections 7 and 8
(relating to public hearings and decisions thereon) apply in place
of the provisions of this subsection.
This subsection states, in its first sentence, the minimum require-
ments of public rule making procedure short of statutory hearing.
Under it agencies might in addition confer with industry advisory
committees, consult organizations, hold informal "hearings," and
the like. Considerations of practicality, necessity, and public inter-
est as discussed in connection with subsection (a) will naturally
govern the agency's determination of the extent to which public
[p. 14]
proceedings should go. Matters of great import, or those where the
public submission of facts will be either useful to the agency or a
protection to the public, should naturally be accorded more elabo-
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STATUTES AND LEGISLATIVE HISTORY 1227
rate public procedures. The agency must analyze and consider all
relevant matter presented. The required statement of the basis and
purpose of rules issued should not only relate to the data so pre-
sented but with reasonable fullness explain the actual basis and
objectives of the rule.
(c) EFFECTIVE DATES.—The required publication or service of
any substantive rule must be made not less than 30 days prior to
its effective date except (1) as otherwise provided by the agency
for good cause found and published or (2) in the case of rules
recognizing exemption or relieving restriction, interpretative rules,
and statements of policy.
This subsection does not provide procedures alternative to notice
and other public proceedings required by the prior subsections of
this section. Nor does it supersede the provisions of subsection (d)
of this section. Where public procedures are omitted as authorized
in certain cases, subsection (c) does not thereby become inopera-
tive. It will afford persons affected a reasonable time to prepare
for the effective date of a rule or rules or to take any other action
which the issuance of rules may prompt. While certain named
kinds of rules are not necessarily subject to the deferred effective
date provided, it does not thereby follow that agencies are required
to make such excepted types of rules operative with less notice or
no notice but, instead, agencies are given discretion in those cases
to fix such future effective date as they may find advisable. The
other exception, upon good cause found and published, is not an
"escape clause" which may be arbitrarily exercised but requires
legitimate grounds supported in law and fact by the required
finding. Moreover, the specification of a 30-day deferred effective
date is not to be taken as a maximum, since there may be cases in
which good administration or the convenience and necessity of
the persons subject to the rule reasonably requires a longer period.
(d) PETITIONS.—Every agency is required to accord any inter-
ested person the right to petition for the issuance, amendment, or
repeal of a rule.
This subsection applies not merely to effective rules existing at
any time but to proposed or tentative rules. Where the latter are
published, agencies should receive petitions for modification
because that is one of the purposes of publishing proposed or tenta-
tive rules. Where such petitions are made, the agency must fully
and promptly consider them, take such action as may be required,
and pursuant to section 6(d) notify the petitioner in case the
request is denied. The agency may either grant the petition, under-
take public rule making proceedings as provided by subsections
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1228 LEGAL COMPILATION—PESTICIDES
(a) and (b) of this section, or deny the petition. The taking or
denial of action would have the same effect and consequences as
the taking or denial of action where, under presently existing legis-
lation, the equivalent of a right of petition is recognized in inter-
ested persons. The mere filing of a petition does not require an
agency to grant it, or to hold a hearing, or engage in any other
public rule making proceedings. The refusal of an agency to
grant the petition or to hold rule making proceedings, therefore,
would not per se be subject to judicial reversal. However, the facts
or considerations brought to the attention of agency by such a
petition might be such as to require the agency to act to prevent
[p. 15]
the rule from continuing or becoming vulnerable upon judicial
review, through declaratory judgment or other procedures pur-
suant to section 10.
SEC. 5. ADJUDICATIONS.—The various subsequent provisions of
section 5 relating to adjudications apply only where the case is
otherwise required by statute to be determined upon an agency
hearing except that, even in that case, the following classes of
operations are expressly not affected: (1) Cases subject to trial de
novo in court, (2) selection or tenure of public officers other than
examiners, (3) decisions resting on inspections, tests, or elections,
(4) military, naval, and foreign affairs functions (5) cases in
which an agency is acting for a court, and (6) the certification of
employee representatives.
The general limitation of this section to cases in which other
statutes require the agency to act upon or after a hearing is impor-
tant. All cases are nevertheless subject to sections 2, 3, 6, 9,10, and
12 so far as those are otherwise relevant.
The numbered exceptions remove from the operation of the
section even adjudications otherwise required by statute to be
made after hearing. The first, where the adjudication ia subject to
a judicial trial de novo, is included because whatever judgment the
agency makes is effective only in a prima facie sense at most and
the party aggrieved is entitled to complete judicial retrial and
decision. The second, respecting the selection and tenure of officers
other than examiners, is included because the selection and con-
trol of public personnel has been traditionally regarded as a dis-
cretionary function which, if to be overturned, should be done by
separate legislation. The third exempts proceedings resting on
inspections, tests, or elections because those methods of determina-
tion do not lend themselves to the hearing process. The fourth
exempts military, naval, and foreign affairs functions for the same
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STATUTES AND LEGISLATIVE HISTORY 1229
reasons that they are exempted from section 4; and in any event,
rarely if ever do statutes require such functions to be exercised
upon hearing. The fifth, exempting cases in which an agency is
acting as the agent for a court, is included because the administra-
tive operation is subject to judicial revision in toto. The sixth,
exempting the certification of employee representatives such as
the Labor Board operations under section 9(c) of the National
Labor Relations Act, is included because these determinations rest
so largely upon an election or the availability of an election. It
should be noted that these exceptions apply only "to the extent"
that the excepted subject is involved and, it may be added, only to
the extent that such subjects are directly involved.
(a) NOTICE.—Persons entitled to notice of an agency hearing
are to be duly and timely informed of (1) the time, place, and
nature of the hearing, (2) the legal authority and jurisdiction
under which it is to be held, and (3) the matters of fact and law
asserted. Where private persons are the moving parties, respon-
dents must give prompt notice of issues controverted in law or
fact; and in other cases the agency may require responsive plead-
ing. In fixing the times and places for hearings the agency must
give due regard to the convenience and necessity of the parties.
The specification of the content of notice, so far as legal author-
ity and the issues are concerned, does not mean that prior to the
commencement of the proceedings an agency must anticipate all
developments and all possible issues. But it does mean that, either
by the formal notice or otherwise in the record, it must appear that
the party [p. 16]
Rule Making
Sec. if. Except to the extent that there is involved (1) any military, naval, or
foreign affairs function of the United States or (2) any matter relating to
agency management or personnel or to public property, loans, grants,
benefits or contracts—
(a) Notice.—General notice of proposed rule making shall be published in
the Federal Register and shall include (1) a statement of the time, place, and
nature of public rule making proceedings; (2) reference to the authority
under which the rule is proposed; and (S) either the terms or substance of the
proposed rule or a description of the subjects and issues involved. Except
where notice or hearing is required by statute, this subsection shall not apply
to interpretative rules, general statements of policy, rules of agency organiza-
tion, procedure, or practice, or in any situation in which the agency for good
cause finds (and incorporates the finding and a brief statement of the reasons
therefore in the rules issued) that notice and public procedure thereon are
impracticable, unnecessary, or contrary to the public interest.
(b) Procedures.—After notice required by this section, the agency shall
afford interested persons an opportunity to participate in the rule making
through submission of written data, views, or argument with or without oppor-
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1230 LEGAL COMPILATION—PESTICIDES
tomity to present the same orally in any manner; and, after consideration of
all relevant matter presented, the agency shall incorporate in any rules
adopted a concise general statement of their basis and purpose. Where rules
are required by law to be made upon the record after opportunity for or upon
an agency hearing, the requirements of sections 7 and 8 shall apply in place
of the provisions of this subsection.
(c) Effective Dates.—The required publication or service of any substan-
tive rule (other than one granting or recognizing exemption or relieving
restriction or interpretative rules and statements of policy) shall be made not
less than thirty days prior to the effective date thereof except as otherwise
provided by the agency upon good cause found and published with the rule.
(d) Petitions.—Every agency shall accord any interested person the right
to petition for the issuance, amendment, or repeal of a rule. [p. 33]
Section 4. The term "naval" in the first exception clause is intended to
include the defense functions of the Coast Guard and the Bureau of Marine
Inspection and Navigation.
Section 4 (b), in requiring the publication of a concise general statement
of the basis and purpose of rules made without formal hearing, is not intended
to require an elaborate analysis of rules or of the detailed considerations upon
which they are based but is designed to enable the public to obtain a general
idea of the purpose of, and a statement of the basic justification for, the rules.
The requirement would also serve much the same function as the whereas
clauses which are now customarily found in the preambles of Executive orders.
[p. 39]
Section 4 (c): This subsection is not intended to hamper the agencies in
cases in which there is good cause for putting a rule into effect immediately,
or at some time earlier than 30 days. The section requires, however, that where
an earlier effective date is desired the agency should make a finding of good
cause therefor and publish its finding along with the rule.
Section 4 (d) simply permits any interested person to petition an agency
for the issuance, amendment, or repeal of a rule. It requires the reception
and consideration of petitions but does not compel an agency to undertake any
rule-making procedure merely because a petition is filed. [p. 40]
1.15a (2) HOUSE COMMITTEE ON THE JUDICIARY
H.R. REP. No. 1980, 79th Cong., 2d Sess. (1946)
ADMINISTRATIVE PROCEDURE ACT
MAY 3, 1946.—Committed to the Committee of the Whole House on the State
of the Union and Ordered to be printed
Mr. WALTER, from the Committee on the Judiciary, submitted the
following
REPORT
[To accompany S. 7]
The Committee on the Judiciary, to whom was referred the bill
(S. 7) to improve the administration of justice by prescribing fair
-------
STATUTES AND LEGISLATIVE HISTORY 1231
administrative procedure, having considered the same, report the
bill favorably to the House, with an amendment, with the recom-
mendation that, as amended, the bill do pass.
The committee amendment is as follows:
Strike out all of the bill after the enacting clause and insert in
lieu thereof the following:
TITLE
SECTION 1. This Act may be cited as the "Administrative Procedure Act".
DEFINITIONS
SEC. 2. As used in this Act—
(a) AGENCY.—"Agency" means each authority (whether or not within or
subject to review by another agency) of the Government of the United States
other than Congress, the courts, or the governments of the possessions, Terri-
tories, or the District of Columbia. Nothing in this Act shall be construed to
repeal delegations of authority as provided by law. Except as to the require-
ments of section 3, there shall be excluded from the operation of this Act (1)
agencies composed of representatives of the parties or of representatives of
organizations of the parties to the disputes determined by them, (2) courts
martial and military commissions, (3) military or naval authority exercised
in the field in time of war or in occupied territory, or (4) functions which by
law expire on the termination of present hostilities, within any fixed period
thereafter, or before July 1,1947, and the functions conferred by the following
statutes: Selective Training and Service Act of 1940; Contract Settlement Act
of 1944; Surplus Property Act of 1944.
(b) PERSON AND PARTY.—"Person" includes individuals, partnerships, cor-
porations, associations, or public or private organizations of any character
other than agencies. "Party" includes any person or agency named or admitted
as a party, or properly seeking and entitled as of right to be admitted as a
party, in any agency proceeding; but nothing herein shall be construed to
prevent an agency from admitting any person or agency as a party for limited
purposes.
[P.I]
(c) RULE AND RULE MAKING.—"Rule" means the whole or any part of any
agency statement of general or particular applicability and future effect
designed to implement, interpret, or prescribe law or policy or to describe the
organization, procedure, or practice requirements of any agency and includes
the approval or prescription for the future of rates, wages, corporate or
financial structures or reorganizations thereof, prices, facilities, appliances,
services, or allowances therefor, or of valuations, costs, or accounting, or
practices bearing upon any of the foregoing. "Rule making" means agency
process for the formulation, amendment, or repeal of a rule.
(d) ORDER AND ADJUDICATION.—"Order" means the whole or any part of
the final disposition (whether affirmative, negative, injunctive, or declaratory
in form) of any agency in any matter other than rule making but including
licensing. "Adjudication" means agency process for the formulation of an
order.
(e) LICENSE AND LICENSING.— "License" includes the whole or part of any
agency permit, certificate, approval, registration, charter, membership, statu-
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1232 LEGAL COMPILATION—PESTICIDES
tory exemption, or other form of permission. "Licensing" includes agency
process respecting the grant, renewal, denial, revocation, suspension, annul-
ment, withdrawal, limitation, amendment, modification, or conditioning of
a license.
(f) SANCTION AND RELIEF.—"Sanction" includes the whole or part of any
agency (1) prohibition, requirement, limitation, or other condition affecting
the freedom of any person; (2) withholding of relief; (3) imposition of any
form of penalty or fine; (4) destruction, taking, seizure, or withholding of
property; (5) assessment of damages, reimbursement, restitution, compensa-
tion, costs, charges, or fees; (6) requirement, revocation, or suspension of a
license; or (7) taking of other compulsory or restrictive action. "Relief"
includes the whole or part of any agency (1) grant of money, assistance,
license, authority, exemption, exception, privilege, or remedy; (2) recognition
of any claim, right, immunity, privilege, exemption, or exception; or (3)
taking of any other action upon the application or petition of, and beneficial
to, any person.
(g) AGENCY PROCEEDING AND ACTION.—"Agency proceeding" means any
agency process as defined in subsections (c), (d), and (e) of this section.
"Agency action" includes the whole or part of every agency rule, order, license,
sanction, relief, or the equivalent or denial thereof, or failure to act.
PUBLIC INFORMATION
SEC. 3. Except to the extent that there is involved (1) any function of the
United States requiring secrecy in the public interest or (2) any matter
relating solely to the internal management of an agency—
(a) RULES.—Every agency shall separately state and currently publish in
the Federal Register (1) descriptions of its central and field organization in-
cluding delegations by the agency of final authority and the established places
at which, and methods whereby, the public may secure information or make
submittals or requests; (2) statements of the general course and method by
which its functions are channeled and determined, including the nature and
requirements of all formal or informal procedures available as well as forms
and instructions as to the scope and contents of all papers, reports, or examina-
tions; and (3) substantive rules adopted as authorized by law and statements
of general policy or interpretations formulated and adopted by the agency for
the guidance of the public, but not rules addressed to and served upon named
persons in accordance with law. No person shall in any manner be required to
resort to organization or procedure not so published.
(b) OPINIONS AND ORDERS.—Every agency shall publish or, in accordance
with published rule, make available to public inspection all final opinions
or orders in the adjudication of cases (except those required for good cause
to be held confidential and not cited as precedents) and all rules.
(c) PUBLIC RECORDS.—Save as otherwise required by statute, matters of
official record shall in accordance with published rule be made available to
persons properly and directly concerned except information held confidential
for good cause found.
RULE MAKING
SEC. 4. Except to the extent that there is involved (1) any military, naval,
or foreign affairs function of the United States or (2) any matter relating
to agency management or personnel or to public property, loans, grants, bene-
fits, or contracts—
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STATUTES AND LEGISLATIVE HISTORY 1233
(a) NOTICE.—General notice of proposed rule making shall be published in
the Federal Register (unless all persons subject thereto are named and either
personally served or otherwise have actual notice thereof in accordance with
[p-2]
law) and shall include (1) a statement of the time, place, and nature of public
rule-making proceedings; (2) reference to the authority under which the rule
is proposed; and (3) either the terms or substance of the proposed rule or a
description of the subjects and issues involved. Except where notice or
hearing is required by statute, this subsection shall not apply to interpretative
rules, general statements of policy, rules of agency organization, procedure, or
practice, or in any situation in which the agency for good cause finds (and
incorporates the finding and a brief statement of the reasons therefor in the
rules issued) that notice and public procedure thereon are impracticable,
unnecessary, or contrary to the public interest.
(b) PROCEDURES.—After notice required by this section, the agency shall
afford interested persons an opportunity to participate in the rule making
through submission of written data, views, or argument with or without
opportunity to present the same orally in any manner; and, after considera-
tion of all relevant matter presented, the agency shall incorporate in any
rules adopted a concise general statement of their basis and purpose. Where
rules are required by statute to be made on the record after opportunity for
an agency hearing, the requirements of sections 7 and 8 shall apply in place
of the provisions of this subsection.
(c) EFFECTIVE DATES.—The required publication or service of any substan-
tive rule (other than one granting or recognizing exemption or relieving
restriction or interpretative rules and statements of policy) shall be made not
less than thirty days prior to the effective date thereof except as otherwise
provided by the agency upon good cause found and published with the rule.
(d) PETITIONS.—Every agency shall accord any interested person the right
to petition for the issuance, amendment, or repeal of a rule. [p. 3]
III. THE SUBSTANCE OF THE BILL
Manifestly the bill does not unduly encroach upon the needs of
any legitimate government operation, although it is of course
operative according to its terms even if it should cause some
administrative inconvenience or changes in procedure. It is brief,
but necessarily not oversimplified. Functional classifications and
exemptions have been made, but in no part of the bill is any
agency exempted by name. The bill is meant to be operative
"across the board" in accordance with its terms, or not at all.
Where one agency has been able to demonstrate that .it should be
exempted, all like agencies have been exempted in general terms.
(See sec. 2 (a)). Where one agency has shown that some particu-
lar operation should be exempted from any particular requirement,
the same function in all agencies has been exempted. No agency
has been favored by special treatment.
The bill is an outline of minimum essential rights and proce-
dures. Agencies may fill in details, so long as they publish them. It
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1234 LEGAL COMPILATION—PESTICIDES
affords private parties a means of knowing what their rights are
and how they may protect them, while administrators are given
[p. 16]
a simple framework upon which to base oi"^ operations as are
subject to the provisions of the bill.
What the bill does in substance may be summarized under four
headings: 1. It provides that agencies must issue as rules certain
specified information as to their organization and procedure, and
also make available other materials of administrative law (sec. 3).
2. It states the essentials of the several forms of administrative
proceedings (sees. 4, 5, and 6) and the general limitations on
administrative powers (sec. 9). 3. It provides in more detail the
requirements for administrative hearings and decisions in cases
in whch statutes require such hearings (sees. 7 and 8). 4. It sets
forth a simplified statement of judicial review designed to afford
a remedy for every legal wrong (sec. 10).
The public information section is basic, because it requires
agencies to take the initiative in informing the public. In stating
the essentials of the different forms of administrative proceedings,
the bill carefully distinguishes between the so-called legislative
functions of administrative agencies (where they issue general
regulations) and their judicial functions (in which they determine
rights or liabilities in particular cases). It provides quite different
procedures for the "legislative" and "judicial" functions of admin-
istrative agencies. In the "rule making" (that is, "legislative")
function it provides that with certain exceptions agencies must
publish notice and at least permit interested parties to submit their
views in writing for agency consideration before the issuance of
general regulations (sec. 4). No hearings are required by the bill
unless statutes already do so in a particular case. Similarly, in
"adjudications" (that is, the "judicial" function) no agency hear-
ings are required unless statutes already do so, but in the latter
case the mode of hearing and decision is prescribed (sec. 5). Where
existing statutes require that either general regulations (called
"rules" in the bill) or particularized adjudications (called "orders"
in the bill) be made after agency hearing or opportunity for such
hearing, then section 7 spells out the minimum requirements for
such hearings, section 8 states how decisions shall be made there-
after, and section 11 provides for examiners to preside at hearings
and make or participate in decisions.
While the administrative power and procedure provisions of sec-
tions 4 through 9 are law apart from court review, the provisions
for judicial review afford parties a method of enforcing their
-------
STATUTES AND LEGISLATIVE HISTORY 1235
rights in proper cases (sec. 10). However, it is expressly provided
that the judicial-review provisions are not operative where stat-
utes otherwise preclude judicial review or where agency action is
by law committed to agency discretion.
The bill is so drafted that its several sections and subordinate
provisions are closely knit. The operative provisions of the bill
should be read apart from the purely formal provisions and minor
functional distinctions. The definitions in section 2 are important,
but they do not indicate the scope of the bill since the subsequent
provisions make many functional distinctions and exceptions. The
public-information provisions of section 3 are of the broadest
application because, while some functions and some operations may
not lend themselves to formal procedure, all administrative opera-
tions should as a matter of policy be disclosed to the public except as
[p. 17]
secrecy may obviously be required or only internal agency "house-
keeping" arrangements may be involved. Sections 4 and 5 pre-
scribe the basic requirements for the making of rules and the adju-
dication of particular cases. In each case, where other statutes
require opportunity for an agency hearing, sections 7 and 8 set
forth the minimum requirements for such hearings and the agency
decisions thereafter while section 11 provides for the appointment
and tenure of examiners who may participate. Section 6 prescribes
the rights of private parties in a number of miscellaneous respects
which may be incidental to rule making, adjudication, or the exer-
cise of any other agency authority. Section 9 limits sanctions, and
section 10 provides for judicial review.
A diagram of the bill is to be found at pages 28-29 of this report.
IV. EXPLANATION OF PROVISIONS
In the following explanation, under each section heading there
appears an italicized synopsis of the provision and a paragraph or
more of analysis or comment. The chart on pages 28 and 29 pro-
vides a diagrammed synopsis of the bill. The full bill is reproduced
as appendix A hereto, which also shows the clarifications it makes
in the similar Senate bill.
[P. 18]
SECTION 4. RULE MAKING
The introductory clause exempts from all of the requirements of
section 4 any rule making so far as there are involved (1) military,
naval, or foreign-affairs functions or (2) matters relating to
agency management or personnel or to public property, loans,
grants, benefits, or contracts.
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1236 LEGAL COMPILATION—PESTICIDES
The principal purpose of this section is, where other statutes do
not require a hearing, to provide that the legislative functions of
administrative agencies shall so far as possible be exercised only
upon public participation on notice as provided in sections 4 (a)
and (b).
The introductory exceptions to the section do not relieve an
agency from any requirements imposed by law apart from this
bill. They apply only "to the extent" that the excepted subject
matter is clearly and directly involved. The phrase "foreign affairs
functions," used here and in some other provisions of the bill, is
not to be loosely interpreted to mean any agency operation merely
because it is exercised in whole or part beyond the borders of the
United States but only those "affairs" which so affect the relations
of the United States with other governments that, for example,
public rule-making provisions would provoke definitely undesirable
international consequences. The exception of matters of manage-
ment or personnel would operate only so far as not inconsistent with
other provisions of the bill relating to those matters. The term
"public property" would include property held by the United
States in trust or as guardian, as Indian property is often held.
The exception of proprietary matters is included because a main
consideration in such cases relates to mechanics, interpretations,
or policy and it is wise to encourage and facilitate the issuance of
rules by dispensing with all mandatory procedural requirements.
Changes can then be sought through the petition procedures of
section 4(d), by which such rule making may also be initially
invoked. But these exceptions are not to be taken as encouraging
agencies not to adopt voluntary public rule-making procedures
where useful to the agency or beneficial to the public. They merely
confer a discretion upon agencies to decide what, if any, public
rule-making procedures shall be utilized in a given situation
within their terms. [p. 23]
SECTION 4 (A) . NOTICE OP EULE MAKING
General notice of proposed rule making must be published in the
Federal Register—unless all persons subject to the rules are named
and are personally served or otherwise have actual notice as
provided by law—and must include (1) the time, -place, and nature
of proceedings, (2) reference to the authority under which held,
and (3) the terms, substance, or issues involved. However, except
where notice and hearing is required by some other statute, the
section does not apply to rules other than those of substance or
where the agency for good cause finds (and incorporates the find-
ing and reasons therefor in the published rule) that notice and
-------
STATUTES AND LEGISLATIVE HISTORY 1237
public procedure are impracticable, unnecessary, or contrary to
the public interest.
The provisions respecting the fullness of notice apply whether or
not, under the terms of the section, it must be published in the
Federal Register. Notice must fairly apprise interested persons of
the issues involved, so that they may present relevant data or
argument. The required specification of legal authority must be
done with particularity. Statements of issues in the general statu-
tory language of legislative delegations of authority to the agency
would not be a compliance with the section. Prior to public pro-
cedures agencies must conduct such nonpublic studies or investiga-
tions as will enable them to formulate issues, or where possible to
issue proposed or tentative rules for the purpose of public proceed-
ings. Summaries and reports may also be issued as aids in securing
public comment or suggestions.
The section governs the application of the public procedures
required by section 4(b) since those procedures only apply where
notice is required by this section. Agencies are given discretion to
dispense with notice (and consequently with public proceedings)
in the case of interpretative rules, general statements of policy, or
rules of agency organization, procedure, or practice; but this does
not mean that they should not undertake public procedures in
connection with such rule making where useful to them or helpful
to the public. The exemption of situations of emergency or neces-
sity is not an "escape clause" in the sense that any agency has
discretion to disregard its terms or the facts. A true and support-
ed or supportable finding of necessity or emergency must be made
and published. "Impracticable" means a situation in which the due,
timely, and required execution of agency functions would be un-
avoidably prevented by its undertaking public rule-making pro-
ceedings. "Unnecessary" means so far as the public is concerned,
as would be the case if a minor or merely technical amendment in
which the public is not particularly interested were involved.
"Public interest" supplements the terms "impracticable" or "unnec-
essary" ; it requires that public rule-making procedures shall not
unreasonably prevent an agency from fulfilling its duty and that,
on the other hand, lack of public concern in rule making warrants
an agency to dispense with public procedure. Where authority
beneficial to the public does not become operative until a rule is
issued, the agency may promulgate the necessary rule immediate-
ly and rely upon supplemental procedures in the nature of a public
reconsideration of the issued rule to satisfy the requirements of
[p. 24]
-------
1238 LEGAL COMPILATION—PESTICIDES
this section. Where public rule-making procedures are dispensed
with, the provisions of subsections (c) and (d) of this section
would nevertheless apply. Notice otherwise required by law apart
from this bill is not repealed or diminished by this section.
SECTION 4 (B) . PUBLIC PROCEDURES IN RULE MAKING
After such notice, the agency must afford interested persons an
opportunity to participate in the rule making at least to the extent
of submitting written data, views, or argument; and, after con-
sideration of such presentations, the agency must incorporate in
any rules adopted a concise general statement of their basis and
purpose. However, where other statutes require rules to be made
after opportunity for hearing, the requirements of sections 7 and 8
(relating to public hearings and decisions thereon) apply in place
of the provisions of this subsection.
The first sentence states the minimum requirements of public
rule-making procedure short of statutory hearing. Under it agen-
cies might in addition confer with industry advisory committees,
consult organizations, hold informal "hearings," and the like. Open
proceedings may be aided by the submission of reports or sum-
maries of data by agency representatives. Where open proceedings
are held, interested persons unable to be present would be entitled
to make written submittals. Considerations of practicality, neces-
sity, and public interest as discussed in connection with section
4 (a) will naturally govern the agency's determination of the
extent to which public proceedings may be carried. Matters of
great import, or those where the public submission of facts will be
either useful to the agency or a protection to the public, should
naturally be accorded more elaborate public procedures. The agency
must keep a record and analyze and consider all relevant matter
presented prior to the issuance of rules. The required statement of
the basis and purpose of rules issued should not only relate to the
data so presented but with reasonable fullness explain the actual
basis and objectives of the rule.
These rule-making procedures must be incorporated in the rules
published pursuant to section 3 (a), although their applicability
may be left to the notice of rule making in a given case and modifi-
cations or extensions of procedure may be made in the notice.
SECTION 4 (C). FUTURE EFFECTIVE DATE OF RULES
The required publication or service of any substantive rule must
be made not less than 30 days prior to its effective date except (1)
as otherwise provided by the agency for good cause found and pub-
lished or (2) in the case of rules recognizing exemption or relieving
-------
STATUTES AND LEGISLATIVE HISTORY 1239
restriction, interpretative rules, and statements of policy.
This section does not repeal or diminish other time requirements
provided by law apart from this bill. It does not provide procedures
alternative to notice and other public proceedings required by the
prior sections. Nor does it supersede the provisions of section 4 (d).
Where public procedures are omitted as authorized in certain cases,
section 4 (c) does not thereby become inoperative. It will afford
persons affected a reasonable time to prepare for the effective date
of a rule or rules or to take any other action which the issuance of
rules may prompt. The specification of a 30-day deferred effective
[p.25]
date is not to be taken as a maximum, since there may be cases in
which good administration or the convenience and necessity of the
persons subject to the rule reasonably require a longer period.
While certain named kinds of rules are not necessarily subject to
the deferred effective date provided, it does not thereby follow
that agencies are required to make such excepted types of rules
operative with less notice or no notice but, instead, agencies may
fix such future effective date as is advisable. The other exception—
upon good cause found and published—is not an "escape clause"
which may be exercised at will but requires legitimate grounds
supported in law and fact by the required finding. Many rules, such
as some agricultural marketing "orders," may be made operative
in less than 30 days because of inescapable or unavoidable limita-
tions of time, because of the demonstrable urgency of the condi-
tions they are designed to correct, and because the parties subject
to them may during the usually protracted hearing and decision
procedures anticipate the regulation. In any event, however, no
rule requiring action may be made effective until a legally reasonable
time after its issuance as judged in the light of all the circumstances.
SECTION 4 (D). PETITIONS RESPECTING RULES
Every agency is required to accord any interested person the
right to petition for the issuance, amendment, or repeal of a rule.
This section applies not merely to effective rules existing at any
time but to proposed or tentative rules. Where such petitions are
made, the agency must fully and promptly consider them, take such
action as may be required, and pursuant to section 6 (d) notify the
petitioner in case the request is denied. The agency may either
grant the petition, undertake public rule-making proceedings as
provided by sections 4 (a) and 4 (b), or deny the petition. The
mere filing of a petition does not require an agency to grant it, or
to hold a hearing, or to engage in other public rule-making pro-
ceedings. But the agency must act on the petition in accordance
-------
1240 LEGAL COMPILATION—PESTICIDES
with procedures set up and published in compliance with section
3 (a). [p.26]
QUASI-LEGISLATIVE FUNCTIONS
SEC. 4. Rule Making.—Except war,
foreign affairs, management, and pro-
prietary functions: (a) notice of rule
making is to be published in certain
instances, (b) thereafter interested
persons are to be permitted to make at
least written submittals for agency
consideration, except that if other
statutes require an agency hearing
then sections 7 and 8 apply, (c) effec-
tive date of rules is to be 30 days
following publication, and (d) any
interested person may petition for
issuance, amendment, or repeal of a
rule. [p. 29]
RULE MAKING
SEC. 4. Except to the extent that there is involved (1) any military, naval,
or foreign affairs function of the United States or (2) any matter relating to
agency management or personnel or to public property, loans, grants, bene-
fits, or contracts—
(a) NOTICE.—General notice of proposed rule making shall be published in
the Federal Register (unless all persons subject thereto are named and either
personally served or otherwise have actual notice thereof in accordance with
law)8 and shall include (1) a statement of the time, place, and nature of
public rule making proceedings; (2) reference to the authority under which
the rule is proposed; and (3) either the terms or substance of the proposed
rule or a description of the subjects and issues involved. Except where notice
or hearing is required by statute, this subsection shall not apply to interpreta-
tive rules, general statements of policy, rules of agency organization, pro-
cedure, or practice, or in any situation in which the agency for good cause
finds (and incorporates the finding and a brief statement of the reasons
therefor in the rules issued) that notice and public procedure thereon are
impracticable, unnecessary, or contrary to the public interest.
(b) PROCEDURES.—After notice required by this section, the agency shall
afford interested persons an opportunity to participate in the rule making
through submission of written data, views, or argument with or without
opportunity to present the same orally in any manner; and, after consider-
ation of all relevant matter presented, the agency shall incorporate in any
rules adopted a concise general statement of their basis and purpose. Where
rules are required by [law] statute to be made [upon] on the record after
opportunity for [or upon]9 an agency hearing, the requirements of sections 7
and 8 shall apply in place of the provisions of this subsection.
(c) EFFECTIVE DATES.—The required publication or service of any substan-
tive rule (other than one granting or recognizing exemption or relieving
restriction or interpretative rules and statements of policy) shall be made not
less than thirty days prior to the effective date thereof except as otherwise
provided by the agency upon good cause found and published with the rule.
(d) PETITIONS.—Every agency shall accord any interested person the right
to petition for the issuance, amendment, or repeal of a rule. [p. 51]
8 The added language supplements the changes explained in notes 6 and 7. There is no reason
to burden the Federal Register with notices addressed to particular parties who have been
personally served or Otherwise have notice.
9 The change is made to conform to the language used in the introductory clause of section
5 respecting adjudications. A statute may, in terms, require a rule or order to be made upon
the record of a hearing, or in the usual case be interpreted as manifesting a Congressional
intention so to require, and in either situation sections 7 and 8 would apply save as other ex-
ceptions are operative.
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STATUTES AND LEGISLATIVE HISTORY
1241
1.15a (3) CONGRESSIONAL RECORD, VOL. 92 (1946)
1.15a(3)(a) March 12: Debated, amended and passed Senate, pp.
2151-2152,2155,2157,2161-2162,2165
vided by the bill for the legislative and
judicial functions of administrative
agencies. In the rule-making, that is,
legislative, function the bill provides
that, with certain exceptions, agencies
must publish notice and at least permit
interested parties to submit their views
in writing for agency consideration be-
fore issuing general regulations. No
hearings are required by the bill unless
statutes already do so in a particular
case. Similarly, in adjudications—that
is, the judicial function—no agency
hearings are required unless statutes
already do so, but in the latter case the
mode of hearing and decision is pre-
scribed. Where existing statutes re-
quire that either general regulations—
which the bill calls rules—or particu-
larized adjudications—which the bill
calls orders—shall be made after
agency hearing or opportunity for such
hearing, then section 7 of the bill spells
out the minimum requirements for
such hearings; section 8 states how de-
cisions shall be made thereafter, and
section 11 provides for examiners to
preside at hearings and make or par-
ticipate in decisions.
While the administrative power and
procedure provisions of sections 4, 5, 6,
7, 8, and 9 are law apart from court re-
view, the provisions for judicial review
provide parties with a method of en-
forcing their rights in a proper case.
However, it is expressly provided that
the judicial review provisions are not
operative where statutes otherwise
preclude judicial review, or where
agency action is by law committed to
agency discretion.
Mr. McCARRAN.
*****
To state it simply, this bill is de-
signed to afford parties affected by
administrative powers a means of
knowing what their rights are, and
how they may be protected. At the
same time, administrators are pro-
vided with a simple course to follow in
making administrative determinations.
The jurisdiction of the courts is clearly
stated. The bill thus provides for pub-
lic information, administrative opera-
tion, and judicial review.
The substance of what the bill does
may be summarized under four head-
ings:
First: It provides that agencies must
issue as rules certain specified infor-
mation as to their organization and
procedure, and also make available
other materials of administrative law.
Second. It states the essentials of the
several forms of administrative pro-
ceedings and the limitations on admin-
istrative powers.
Third. It provides in more detail the
requirements for administrative hear-
ings and decisions in cases in which
statutes require such hearings.
Fourth. It sets forth a simplified
statement of judicial review designed
to afford a remedy for every legal
wrong.
The first of those four points is basic,
because it requires agencies to take the
initiative in informing the public. In
stating the essentials of the different
forms of administrative proceedings,
the bill carefully distinguishes between
the so-called legislative functions of
administrative agencies—where they
issue general regulations—and their
judicial functions—in which they de-
termine rights or liabilities in particu-
lar cases.
Quite different procedures are pro-
[p.2151]
Sections 4 and 5 of the bill prescribe
the basic requirements for the making
of rules and the adjudication of par-
ticular cases. In each case, where other
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1242
LEGAL COMPILATION—PESTICIDES
statutes require opportunity for an
agency hearing, sections 7 and 8 set
forth the minimum requirements for
such hearings and the agency decisions
thereafter, while section 11 provides
for the appointment and tenure of ex-
aminers who may participate. Section
6 prescribes the rights of private par-
ties in a number of miscellaneous re-
spects which may be incidental to rule
making, adjudication, or the exercise
of any other agency authority. Section
9 limits sanctions, and section 10 pro-
vides for judicial review.
*****
The term "rule making" is defined to
mean agency process for the formula-
tion, amendment, or repeal of a rule,
and includes any prescription for the
future of rates, wages, financial struc-
tures, and so on.
The term "order" is defined to mean
the final disposition of any matter,
other than rule making but including
licensing, whether or not affirmative,
negative, or declaratory in form.
[p. 2152]
The definitions of the Walter-Logan
bill were imperfect and confusing.
Rules were so defined as to include
"orders" and were limited to interpre-
tations of terms of statutes. That bill,
therefore, failed to distinguish between
substantive, interpretive, and proce-
dural rules. The pending bill exempts
from its procedural requirements all
interpretive, organizational, and pro-
cedural rules, because under present
law interpretive rules, being merely
adaptations of interpretations of stat-
utes, are subject to a more ample de-
gree of judicial review, and because the
problem with respect to the other ex-
empted types of rules is to facilitate
their issuance rather than to supply
procedures.
*****
Section 4 concerns rule making. The
introductory clause exempts from all
of the requirements of section 4 any
rule making, so far as there are in-
volved military, naval, or foreign af-
fairs functions, or matters relating to
agency management or personnel, or
to public property, loans, grants, bene-
fits, or contracts.
Mr. President, I wish the Senate
would give close consideration to what
I am about to discuss, because it is all
important.
Subsection (a) of section 4 concerns
notice. It provides that general notice
of proposed rule making must be pub-
lished in the Federal Register and must
include the time, place, and nature of
the proceedings, a reference to the au-
thority under which such proceedings
are held, and the terms, substance, or
issues involved. However, except where
notice and hearing is required by some
other statute, the subsection does not
apply to rules other than those of sub-
stance, or where the agency for good
cause finds, and incorporates the find-
ing and reasons therefor in the pub-
lished rule, that notice and public pro-
cedure are impracticable, unnecessary,
or contrary to the public interest.
Subsection (b) of section 4 concerns
procedures. This subsection provides
that after such notice as required by
the preceding subsection, the agency
must afford interested persons an op-
portunity to participate in the rule-
making, at least to the extent of sub-
mitting written data, views, or argu-
ment. This subsection also provides
that after consideration of such pre-
sentations, the agency must incorpo-
rate in any rules adopted a concise
general statement of their basis and
purpose. However, where other stat-
utes require rules to be made after
hearing, the requirements of sections
7 and 8, which relate to public hearings
and decisions thereon, apply in place of
the provisions of this subsection.
Subsection (c) of section 4 refers to
effective dates. The required publica-
tion or service of any substantive rule
must, under this provision, be made
not less than 30 days prior to the ef-
fective date of such rule, except as
-------
STATUTES AND LEGISLATIVE HISTORY
1243
otherwise provided by the agency for
good cause found and published, or, in
the case of rules recognizing exemp-
tion or relieving restriction, interpreta-
tive rules, and statements of policy.
Subsection (d) of section 4 concerns
petitions, and provides that every
agency shall accord any interested per-
son the right to petition for the issu-
ance, amendment, or repeal of a rule.
[p.2155]
Section 7 concerns hearings and ap-
plies only where hearings are required
by section 4 or 5.
[p.2157]
Mr. JOHNSON of Colorado.
The proposed act is said by its drafters to be
designed to achieve four essential and simple
purposes:
"(1) It requires administrative agencies to
publish their organizations and procedures, and
to make available to public inspection their
orders and releases.
"(2) As to rule making, it requires that
agencies publish notice and at least permit
interested parties to submit views or data for
consideration.
" (3) As to adjudication, it provides that, in
the absence of agreement through informal
methods, agencies must accord the parties
notice, hearing, and decision before responsible
officers, with provision for the segregation of
deciding and prosecuting functions.
"(4) As to judicial review, it provides forms
of review actions for the determination of all
questions of law in all matters not expressly
committed to executive discretion."
The short title of the act is given as the
"Administrative Procedure Act."
[p. 2161]
Section 4 of the proposed act covers the sub-
ject of "adjudication" and provides that in
every case of administrative adjudication in
which the rights, duties, obligations, privileges,
benefits, or other legal relations of any person
are required to be determined only after oppor-
tunity for an administrative hearing (except to
the extent that if there is directly involved any
matter subject to a subsequent trial of the law
and facts de novo in any court notice shall be
given [subsec. (a)]).
The introductory double exception to the sec-
tion removes from the operations of sections 4,
6, and 7 all administrative procedures in which
the law concerned does not require rules or
orders to be made upon a hearing and all mat-
ters subject to a subsequent trial de novo in
any court.
[p.2162]
[Committee amended bill]
RULE MAKING
SEC. 4. Except to the extent that there is in-
volved (1) any military, naval, or foreign affairs
function of the United States or (2) any matter
relating to agency management or personnel
or to public property, loans, grants, benefits, or
contracts—
(a) Notice: General notice of proposed rule
making shall be published in the Federal Regis-
ter and shall include (1) a statement of the
time, place, and nature of public rule making
proceedings ; (2) reference to the authority un-
der which the rule is proposed; and (3) either
the terms or substance of the proposed rule or
a description of the subjects and issues involved.
Except where notice or hearing is required by
statute, this subsection shall not apply to inter-
pretative rules, general statements of policy,
rules of agency organization, procedure, or prac-
tice, or in any situation in which the agency for
good cause finds (and incorporates the finding
and a brief statement of the reasons therefor
in the rules issued) that notice and public pro-
cedure thereon are impracticable, unnecessary,
or contrary to the public interest.
(b) Procedures: After notice required by this
section, the agency shall afford interested per-
sons an opportunity to participate in the rule
making through submission of written data,
views, or argument with or without opportunity
to present the same orally in any manner; and,
after consideration of all relevant matter pre-
sented, the agency shall incorporate in any
rules adopted a concise general statement of
their basis and purpose. Where rules are re-
quired by law to be made upon the record after
opportunity for or upon an agency hearing, the
requirements of sections 7 and 8 shall apply in
place of the provisions of this subsection.
(c) Effective dates: The required publication
or service of any substantive rule (other than
one granting or recognizing exemption or re-
lieving restriction or interpretative rules and
statements of policy) shall be made not less
than 30 days prior to the effective date thereof
except as otherwise provided by the agency upon
good cause found and published with the rule.
(d) Petitions: Every agency shall accord any
interested person the right to petition for the
issuance, amendment, or repeal of a rule.
[p.2165]
-------
1244
LEGAL COMPILATION—PESTICIDES
1.15a(3)(b) May 24: Debated, amended and passed House, pp.
5645,5649,5650-5651,5656,5660-5661
ADMINISTRATIVE PROCEDURE ACT several forms of administrative pro-
ceedings and the general limitations on
administrative powers.
Third. It provides in more detail the
requirements for administrative hear-
ings and decisions in cases in which
statutes require such hearings.
Fourth. It sets forth a simplified
statement of judicial review designed
to afford a remedy for every legal
wrong.
[p. 5645]
But this bill does more than merely
analyze the administrative process and
lay down the forms of procedure for
each. It really deals with three sepa-
rate subjects: First, public informa-
tion ; second, administrative operation;
and third, judicial review.
The first operative section of the bill
is basic and requires agencies to issue
certain information which is essential
to inform the public about the sub-
stance and the procedure of adminis-
trative law. It requires that agencies
state their organizational set-ups, pro-
mulgate statements respecting their
procedures, and make available as reg-
ulations the substantive and interpre-
tative rules which they have framed
for the guidance of the public.
Sections 4, 5, 6,8,9, and 11 deal with
administrative operations. Section 4 re-
lates to the legislative functions of ad-
ministrative agencies and provides
that where Congress has not required
hearings, with some exceptions, the
agency shall give notice of the making
of proposed regulations and afford in-
terested parties an opportunity for the
informal submission and consideration
of their views or requests. Section 5
deals with administrative adjudica-
tions of particular cases where Con-
gress has required adjudications to be
made upon a hearing. Sections 7, 8,
and 11 spell out the details of hearing
and decision procedures in all cases in
which, by other legislation, Congress
Mr. SABATH. Mr. Speaker, I call up
House Resolution 615 and ask for its
immediate consideration.
The Clerk read the resolution, as
follows:
Retolved. That upon the adoption of this
resolution it shall be in order to move that the
House resolve itself into the Committee of the
Whole House on the State of the Union for the
consideration of the act (S. 7) to improve the
administration of justice by prescribing fair
administrative procedure. That after general
debate, which shall be confined to the act and
continue not to exceed 2 hours, to be equally
divided and controlled by the chairman and the
ranking minority member of the Committee on
the Judiciary, the act shall be read for amend-
ment under the 6-minute rule. At the conclusion
of the consideration of the act for amendment,
the Committee shall rise and report the act to
the House with such amendments as may have
been adopted and the previous question shall
be considered as ordered on the act and amend-
ments thereto to final passage without inter-
vening motion except one motion to recommit.
TO IMPROVE ADMINISTRATIVE PROCEDURE
Mr. SABATH. Mr. Speaker, later on
I shall yield 30 minutes to the gentle-
man from Michigan [Mr. MICHENER].
Mr. Speaker, House Resolution 615
makes in order the consideration of
Senate 7 as amended by the Committee
on the Judiciary. The bill aims to im-
prove the administration of justice by
prescribing fair administrative proce-
dure. The rule is an open rule, and pro-
vides for 2 hours of general debate.
Mr. Speaker, I hope this is only the
beginning of legislation to improve the
administration of justice and that it
will bring out real justice to all those
who are obliged to face our courts.
*****
What the bill does, in substance, may
be summarized under four headings:
First. It provides that agencies must
issue as rules certain specified infor-
mation as to their organization and
procedure, and also make available
other materials of administrative law.
Second. It states the essentials of the
-------
STATUTES AND LEGISLATIVE HISTORY
1245
has required an agency hearing. Sec-
tion 9 states certain limitations upon
the penalties or relief which agencies
may impose or confer in any case. Sec-
tion 6 deals with the investigative pow-
ers and other incidental matters of im-
portance.
In the all-important field of judicial
review section 10 is a complete state-
ment of the subject. It prescribes brief-
ly when there may be judicial review
and how far the courts may go in ex-
amining into a given case.
I shall discuss all these matters in
greater detail next in taking up the bill
section by section, subsection by sub-
section.
[p.5649]
BULB MAKING, SECTION 4
Section 4 deals with the very impor-
tant subject of rule making. From it,
however, are exempted: First, mili-
tary, naval, or foreign affairs func-
tions; and second, matters relating to
agency management or personnel or
to public property, loans, grants, bene-
fits, and contracts. The exemption of
military and naval functions needs no
explanation here. The exempted for-
eign affairs are those diplomatic func-
tions of high importance which do not
lend themselves to public procedures
and with which the general public is
ordinarily not directly concerned. The
exemption of proprietary matters is
included because in those cases the
Government is in the position of an
individual citizen and is concerned with
its own property, funds, or contracts.
NOTICE OF RULE MAKING, SECTION 4 (A)
There are two particularly impor-
tant aspects of section 4 (a), which
deals with the notice of rule making.
In the first place, where notice is re-
quired, it should be complete and spe-
cific as the subsection indicates on its
face. In the second place, except where
notice and hearing are required by
some other statute, the agency by this
provision is authorized to dispense
with notice where it finds for good
cause that notice and public procedure
thereon are impracticable, unneces-
sary, or contrary to the public interest.
This latter is not an escape clause but
one which, as the committee report ex-
plains, may be made operative only
where facts and interests are such that
notice and proceedings are impossible
or manifestly unnecessary.
PROCEDURES, SECTION 4 (B)
The second subsection of section 4 is
designed to provide that, where other
statutes do not require an agency hear-
ing, the legislative functions in admin-
istrative agencies shall, so far as pos-
sible, be exercised only upon some form
of public participation after notice.
That is, an agency may permit parties
to submit written statements, confer
with industry advisory committees,
hold open meetings, and the like. What-
ever method is adopted, the agency
must consider the data or argument so
presented by interested people and in-
corporate a concise general statement
of their basis and purpose in any rules
it issues.
The effect of this provision will be to
enable parties to express themselves
in some informal manner prior to the
issuance of rules and regulations, so
that they will have been consulted be-
fore being faced with the accomplished
fact of a regulation which they may
not have anticipated or with reference
to which they have not been consulted.
This provision will make for good pub-
lic relations on the part of administra-
tive agencies. Wisely used and faith-
fully executed, as it must be, it should
be of great aid to administrative agen-
cies by affording them a simple statu-
tory means of apprising'the public of
what they intend to do and afford-
ing the 'interested public a nonburden-
some method of presenting its side of
the case. Day by day Congress takes
account of the interests and desires of
the people in framing legislation; and
there is no reason why administrative
agencies should not do so when they
-------
1246
LEGAL COMPILATION—PESTICIDES
exercise legislative functions which the
Congress has delegated to them.
EFFECTIVE DATE OF RULES, SECTION 4 (C)
Under section 4 (c) agencies are re-
quired, in addition to the foregoing, to
defer the effective date of any sub-
stantive rule for not less than 30 days
except as they may specifically provide
otherwise for good cause or in the case
of rules recognizing exemptions or re-
lieving restrictions, and so forth. This
section places the burden upon admin-
istrative agencies to justify in law and
fact the issuance of any rule effective
in less than 30 days. Rules may be
made effective in a legally responsible
time less than 30 days because of the
shown urgency of conditions coupled
with demonstrated and unavoidable
limitations of time. The section re-
quires agencies to proceed with the
convenience or necessity of the people
[p. 5650]
affected as the primary consideration,
so that an agency may not itself be
dilatory and then issue a rule requiring
compliance forthwith.
PETITIONS, SECTION 4 (D)
Section 4 (d) is of the greatest im-
portance because it is designed to af-
ford every properly interested person
statutory authority to petition for the
issuance, amendment, or repeal of a
rule. No agency may receive such peti-
tions in a merely pro forma manner.
Every agency possessing rule-making
authority will be required to set up pro-
cedures for the receipt, consideration,
and disposition of these petitions. The
right of petition is written into the
Constitution itself. This subsection
confirms that right where Congress
has delegated legislative powers to ad-
ministrative agencies. As in connection
with the prior provisions of section 4,
this subsection should be a most useful
instrument for both improving the pub-
lic relations of administrative agencies
and protecting the public by affording
interested persons a legal and regular
means of securing the issuance, change,
or rescission of a rule.
[p. 5651]
HEARINGS, SECTION 7
It will be recalled that section 4—re-
lating to rule making—and section 5—
relating to the determination of partic-
ular cases—refer to situations in which
Congress has by some other statute re-
quired an agency to act upon a hearing.
Accordingly sections 7 and 8, which I
am about to discuss, state the requi-
sites of statutory agency hearings and
decisions.
[p. 5652]
Mr. GRANGER. There are a number
of us in Congress, of course, who are
not lawyers. This bill I suppose is fully
understood by those who are members
of the legal profession. As I under-
stood the purpose of the bill—I was
somewhat confused by the gentleman's
statement that it was to regulate bu-
reaus—my impression was that it was
simply a bill to make uniform rules
promulgated by the bureaus and prac-
tice before the various boards and com-
missions of the country. Is not that
generally what it is supposed to do ?
Mr. GWYNNE of Iowa. No; I would
not say that was all of it. It does not
as a matter of fact make uniform prac-
tice before bureaus and tribunals. It
requires these agencies of Government
in their practice to maintain certain
minimum standards. It is an attempt
to bring into the practice of these bu-
reaus and tribunals those principles of
due process that we understand and
that have been enforced in the courts.
If I may proceed for a few minutes I
believe I will make these things clear
as I go along. I really wish to touch the
bill a little. I will yield later if I have
time.
In the matter of rule making, the bill
provides, for instance, this in sub-
stance: It requires the agency to give
notice of its intention to make rules
and regulations. It requires the agency
to allow interested parties to appear
-------
STATUTES AND LEGISLATIVE HISTORY
1247
and state their views and request that
certain rules and regulations be
adopted. That would be much like the
hearings that we now have before our
committees in the House. Incidentally,
that practice is now being followed by
certain agencies of the Government.
Then it requires that these rules or
regulations which have the effect of
law must be published in the Federal
Register and go into effect at some
future date. That is stating it very
briefly but that is the substance of
what is required on the important sub-
ject of rule making.
[p. 5656]
Mr. ROBSION of Kentucky. Some
of the most commendable features of
this bill are:
First. It defines "agency," "person,"
"party," "rule," "rule-making," "or-
der" and "adjudication," "license" and
"licensing," "sanction" and "relief."
Second. It provides that these orders,
rules, and directives can only be
adopted after reasonable notice, and,
when once adopted, they must be pub-
lished in the Federal Register. These
records are open to the public, and they
cannot be amended or changed without
giving a hearing to interested parties.
Third. This bill recognizes the prin-
ciples on which our three branches of
government are based so that the pro-
secutor may not get up the evidence,
prosecute the case, and, at the same
time, decide the case.
Fourth. The interested parties must
be given proper notice of the legal and
factual issues, with due time to exam-
ine, consider, and prepare for them and
the parties who are entitled to appear
on their own behalf or by counsel either
an attorney at law or other person who
has been admitted to appear before
such board or agency.
Fifth. The agency is required to af-
ford the parties an opportunity for set-
tlement or adjustment of the issues
involved where the nature of the pro-
ceeding and the public interest permit.
Sixth. All presiding officers and de-
ciding officers are to operate imparti-
ally. Such officer may disqualify him-
self and a party to the proceeding may
file proper affidavit to show that the
presiding officer has personal bias or is
otherwise disqualified. These officers
may exclude irrelevant, immaterial, or
unduly repetitious evidence.
These are only a few of the many
provisions of this bill that leads us to
believe that it will improve the admin-
istration of justice in administrative
procedure of the various agencies and
further protect the constitutional
rights and the interest of the American
people.
[p.5660]
Mr. KEFAUVER.
In this complex day when Govern-
ment is interested in so many things, it
is, of course, necessary to have admin-
istrative agencies which must of neces-
sity be able to make some rules and
regulations and to act in quasi-judicial
positions in certain instances. Con-
gress cannot, by the very complexity of
the situation, make all of the detailed
rules and regulations. But in connec-
tion with the administration of the
agencies, the lawyers of America, the
businessmen, and interested people
have for many years been perplexed in
trying to find some way to get unifor-
mity into the making and publication
of regulations and in obtaining a re-
view procedure. Some of the agencies
for many years have resisted various
administrative procedure bills that
have been presented on the theory that
the bills would unduly hamstring them
in the operation of their departments.
On the other hand, some lawyers of
America and many others wanted more
drastic rules for the regulation of
agencies than the Congress has been
willing to impose. Finally the agencies
have come to realize that some orderly
administration must be worked out for
them and they now join in the approval
of this legislation.
-------
1248
LEGAL COMPILATION—PESTICIDES
Various bar associations and com-
mittees that have worked on this mat-
ter have likewise joined in recommend-
ing it.
I have noticed in the debate on the
bill that various Members have felt
that in some instances the bill went
too far, in other instances it did not
go far enough; some things should be
done that are not done and some things
should not be done that are-done. This
bill will not be entirely satisfactory to
everyone but it marks an excellent be-
ginning. Only after years of practice,
experience, and application can we
come to see the places where it will
need remedying and where it will need
strengthening. I think it is going to be
greatly in the public interest to have
uniform administration in the various
agencies of the Government.
[p. 5661]
1.15a (3)(c) May 27: Senate concurs in the House amendments,
p. 5788
[No Relevant Discussion on Pertinent Section]
1.15b ADMINISTRATIVE PROCEDURE AND RULE MAKING
September 6,1966, P.L. 89-554, §553, 80 Stat. 383
§553. Rule making
(a) This section applies, according to the provisions thereof,
except to the extent that there is involved—
(1) a military or foreign affairs function of the United
States; or
(2) a matter relating to agency management or personnel
or to public property, loans, grants, benefits, or contracts.
(b) General notice of proposed rule making shall be published
in the Federal Register, unless persons subject thereto are named
and either personally served or otherwise have actual notice there-
of in accordance with law. The notice shall include—
(1) a statement of the time, place, and nature of public
rule making proceedings;
(2) reference to the legal authority under which the rule
is proposed; and
(3) either the terms or substance of the proposed rule or a
description of the subjects and issues involved.
Except when notice or hearing is required by statute, this sub-
section does not apply—
[p.383]
(A) to interpretative rules, general statements of policy,
or rules of agency organization, procedure, or practice; or
(B) when the agency for good cause finds (and incorpo-
rates the finding and a brief statement of reasons therefor
in the rules issued) that notice and public procedure thereon
are impracticable, unnecessary, or contrary to the public
interest.
-------
STATUTES AND LEGISLATIVE HISTORY 1249
(c) After notice required by this section, the agency shall give
interested persons an opportunity to participate in the rule making
through submission of written data, views, or arguments with or
without opportunity for oral presentation. After consideration of
the relevant matter presented, the agency shall incorporate in the
rules adopted a concise general statement of their basis and pur-
pose. When rules are required by statute to be made on the record
after opportunity for an agency hearing, sections 556 and 557 of
this title apply instead of this subsection.
(d) The required publication or service of a substantive rule
shall be made not less than 30 days before its effective date, except—
(1) A substantive rule which grants or recognizes an ex-
emption or relieves a restriction;
(2) interpretative rules and statements of policy; or
(3) as otherwise provided by the agency for good cause
found and published with the rule.
(e) Each agency shall give an interested person the right to
petition for the issuance, amendment, or repeal of a rule.
[p. 384]
1.15b (1) HOUSE COMMITTEE ON THE JUDICIARY
H.R. REP. No. 901, 89th Cong., 1st Sess. (1965)
TITLE 5, UNITED STATES CODE, "GOVERNMENT
ORGANIZATION AND EMPLOYEES"
AUGUST 31, 1965.—Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
Mr. WILLIS, from the Committee on the Judiciary, submitted the
following
REPORT
[To accompany H.R. 10104]
The Committee on the Judiciary, to whom was referred the bill
(H.R. 10104) to enact Title 5, United States Code, "Government
Organization and Employees," codifying the general and perma-
nent laws relating to the organization of the Government of the
United States and to its civilian officers and employees, having
considered the same, report favorably thereon without amendment
and recommend that the bill do pass.
PRELIMINARY STATEMENT
Purpose.—The purpose of this bill is to restate in comprehensive
form, without substantive change, the statutes in effect before
-------
1250 LEGAL COMPILATION—PESTICIDES
July 1, 1965, that relate to Government employees, the organiza-
tion and powers of Federal agencies generally, and administrative
procedure, and to enact title 5 of the United States Code. In the
revised title 5, simple language has been substituted for awkward
and obsolete terms, and superseded, executed, and obsolete statutes
have been eliminated. This bill is a part of the program of the
Committee on the Judiciary of the House of Representatives to
enact into law all fifty titles of the United States Code.
[p.l]
SUBCHAPTER II—ADMINISTRATIVE PROCEDURE
Sec.
551. Definitions.
552. Publication of information, rules, opinions, orders, and public records.
553. Rule making.
554. Adjudications.
555. Ancillary matters.
556. Hearings; presiding employees; powers and duties; burden of proof;
evidence; record as basis of decision.
557. Initial decisions; conclusiveness; review by agency; submissions by par-
ties ; contents of decisions; record.
558. Imposition of sanctions; determination of applications for licenses; sus-
pension, revocation, and expiration of licenses.
559. Effect on other laws; effect of subsequent statute.
[p. 10]
SECTION 553
Derivation: United States Code Revised Statutes and Statutes at Large
5 U.S.C. 1003 June 11, 1946, ch. 324, § 4, 60 Stat. 238.
In subsection (a) (1), the words "or naval" are omitted as in-
cluded in "military".
In subsection (b), the word "when" is substituted for "in any
situation in which".
In subsection (c), the words "for oral presentation" are substi-
tuted for "to present the same orally in any manner". The words
"sections 556 and 557 of this title apply instead of this subsection"
are substituted for "the requirements of sections 1006 and 1007 of
this title shall apply in place of the provisions of this subsection".
Standard changes are made to conform with the definitions
applicable and the style of this title as outlined in the preface to
the report.
[p. 12]
-------
STATUTES AND LEGISLATIVE HISTORY 1251
1.15b (2) SENATE COMMITTEE ON THE JUDICIARY
S. REP. No. 1380, 89th Cong., 2d Sess. (1966)
TITLE 5, UNITED STATES CODE, "GOVERNMENT
ORGANIZATION AND EMPLOYEES"
JULY 21,1966.—Ordered to be printed
Mr. ERVIN, from the Committee on the Judiciary, submitted the
following
REPORT
[To accompany H.R. 10104]
The Committee on the Judiciary, to which was referred the bill
(H.R. 10104), to enact title 5, United States Code, "Government
Organization and Employees," codifying the general and perma-
nent laws relating to the organization of the Government of the
United States and to its civilian officers and employees, having
considered the same, reports favorably thereon, with amendments,
and recommends that the bill, H.R. 10104, as amended, do pass.
[p.l]
SECTION 553
Derivation: United States Code Revised Statutes and Statutes at Large
5 U.S.C. 1003 June 11,1946, ch. 324, § 4, 60 Stat. 238.
In subsection (a) (1), the words "or naval" are omitted as in-
cluded in military".
In subsection (b), the word "when" is substituted for "in any
situation in which".
In subsection (c), the words "for oral presentation" are substi-
tuted for "to present the same orally in any manner". The words
"sections 556 and 557 of this title apply instead of this subsection"
are substituted for "the requirements of sections 1006 and 1007
of this title shall apply in place of the provisions of this
subsection".
Standard changes are made to conform with the definitions
applicable and the style of this title as outlined in the preface to
the report.
[p. 28]
1.15b(3) CONGRESSIONAL RECORD
1.15b (3) (a) VOL. Ill (1965), Sept. 7: Passed House, p. 22954
[No Relevant Discussion on Pertinent Section]
-------
1252
LEGAL COMPILATION—PESTICIDES
1.15b (3) (b) VOL. 112 (1966), July 25: Amended and passed Sen-
ate, p.17010
[No Relevant Discussion on Pertinent Section]
1.15(3)(c) VOL. 112 (1966), Aug. 11: House concurs in Senate
amendments, p. 19077
Mr. TUCK (interrupting the read-
ing). Mr. Speaker, I ask unanimous
consent that further reading of the
Senate amendments be dispensed with,
and that they be printed in the REC-
ORD.
The SPEAKER. Is there objection
to the request of the gentleman from
Virginia?
There was no objection.
The SPEAKER. Is there objection
to the request of the gentleman from
Virginia?
Mr. POFF. Mr. Speaker, reserving
the right to object—and I shall not
object—may I inquire of my dis-
tinguished colleague from Virginia
whether any of the amendments made
in the other body affect the substance
of the title?
Mr. TUCK. Mr. Speaker, if the gen-
tleman will yield, the amendments do
not affect the substance of the title.
They are only clerical amendments,
and do not make any change in sub-
stantive law.
The original bill passed this body
unanimously. It passed the Senate
unanimously. The amendments were
adopted by the Senate unanimously.
Mr. POFF. Mr. Speaker, I thank
my colleague, and withdraw my res-
ervation.
The SPEAKER. Is there objection
to the request of the gentleman from
Virginia?
There was no objection.
The Senate amendments were con-
curred in.
A motion to reconsider was laid on
the table.
[p. 19077]
1.16 JUDICIAL REVIEW; RELIEF PENDING REVIEW;
SCOPE, AS REVISED
5 U.S.C. §§705, 706(2) (A), (B), (C), (D) (1966)
[Referred to in 15 U.S.C. §1474(b)(3)(4)]
JUDICIAL REVIEW AND SCOPE
5 § 705. Relief pending review
When an agency finds that justice so requires, it may postpone
the effective date of action taken by it, pending judicial review. On
such conditions as may be required and to the extent necessary to
prevent irreparable injury, the reviewing court, including the
court to which a case may be taken on appeal from or on applica-
tion for certiorari or other writ to a reviewing court, may issue all
necessary and appropriate process to postpone the effective date of
an agency action or to preserve status or rights pending conclusion
of the review proceedings. Pub.L. 89-554, Sept. 6, 1966, 80 Stat.
393.
-------
STATUTES AND LEGISLATIVE HISTORY 1253
§ 706. Scope of review
To the extent necessary to decision and when presented, the re-
viewing court shall decide all relevant questions of law, interpret
constitutional and statutory provisions, and determine the mean-
ing or applicability of the terms of an agency action. The review-
ing court shall—
(1) compel agency action unlawfully withheld or unreason-
ably delayed; and
(2) hold unlawful and set aside agency action, findings,
and conclusions found to be—
(A) arbitrary, capricious, an abuse of discretion, or
otherwise not in accordance with law;
(B) contrary to constitution right, power, privilege,
or immunity;
(C) in excess of statutory jurisdiction, authority, or
limitations, or short of statutory right;
(D) without observance of procedure required by law;
(E) unsupported by substantial evidence in a case
subject to sections 556 and 557 of this title or otherwise
reviewed on the record of an agency hearing provided by
statute; or
(F) unwarranted by the facts to the extent that the
facts are subject to trial de novo by the reviewing court.
In making the foregoing determinations, the court shall review the
whole record or those parts of it cited by a party, and due account
shall be taken of the rule of prejudicial error. Pub.L 89-554, Sept.
6, 1966, 80 Stat. 393.
1.16a JUDICIAL INTERIM RELIEF AND REVIEW OF AGEN-
CIES ACTS
June 11, 1946, P.L. 79-404, §lO(d), (e), 60 Stat. 243
JUDICIAL REVIEW
SEC. 10. Except so far as (1) statutes preclude judicial review or
(2) agency action is by law committed to agency discretion—
(a) RIGHT OP REVIEW.—Any person suffering legal wrong be-
cause of any agency action, or adversely affected or aggrieved by
such action within the meaning of any relevant statute, shall be
entitled to judicial review thereof.
(b) FORM AND VENUE OF ACTION.—The form of proceeding for
judicial review shall be any special statutory review proceeding
relevant to the subject matter in any court specified by statute or, in
the absence or inadequacy thereof, any applicable form of legal
action (including actions for declaratory judgments or writs of
-------
1254 LEGAL COMPILATION—PESTICIDES
prohibitory or mandatory injunction or habeas corpus) in any
court of competent jurisdiction. Agency action shall be subject
to judicial review in civil or criminal proceedings for judicial
enforcement except to the extent that prior, adequate, and exclu-
sive opportunity for such review is provided by law.
(c) REVIEW ABLE ACTS.—Every agency action made reviewable
by statute and every final agency action for which there is no other
adequate remedy in any court shall be subject to judicial review.
Any preliminary, procedural, or intermediate agency action or
ruling not directly reviewable shall be subject to review upon the
review of the final agency action. Except as otherwise expressly
required by statute, agency action otherwise final shall be final for
the purposes of this subsection whether or not there has been
presented or determined any application for a declaratory order,
for any form of reconsideration, or (unless the agency otherwise
requires by rule and provides that the action meanwhile shall be
inoperative) for an appeal to superior agency authority.
(d) INTERIM RELIEF.—Pending judicial review any agency is
authorized, where it finds that justice so requires, to postpone the
effective date of any action taken by it. Upon such conditions as
may be required and to the extent necessary to prevent irreparable
injury, every reviewing court (including every court to which a
case may be taken on appeal from or upon application for certio-
rari or other writ to a reviewing court) is authorized to issue all
necessary and appropriate process to postpone the effective date
of any agency action or to preserve status or rights pending
conclusion of the review proceedings.
(e) SCOPE OP REVIEW.—So far as necessary to decision and where
presented the reviewing court shall decide all relevant questions of
law, interpret constitutional and statutory provisions, and deter-
mine the meaning or applicability of the terms of any agency
action. It shall (A) compel agency action unlawfully withheld or
unreasonably delayed; and (B) hold unlawful and set aside agency
action, findings, and conclusions found to be (1) arbitrary, capri-
cious, an abuse of discretion, or otherwise not in accordance with
law; (2) contrary to constitutional right, power, privilege, or
[p. 243]
immunity; (3) in excess of statutory jurisdiction, authority, or
limitations, or short of statutory right; (4) without observance of
procedure required by law; (5) unsupported by substantial evi-
dence in any case subject to the requirements of sections 7 and 8 or
otherwise reviewed on the record of an agency hearing provided
by statute; or (6) unwarranted by the facts to the extent that the
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STATUTES AND LEGISLATIVE HISTORY 1255
facts are subject to trial de novo by the reviewing court. In making
the foregoing determinations the court shall review the whole rec-
ord or such portions thereof as may be cited by any party, and due
account shall be taken of the rule of prejudicial error.
[p. 244]
1.16a (1) SENATE COMMITTEE ON THE JUDICIARY
S. REP. No. 752, 79th Cong., 1st Sess. (1945)
ADMINISTRATIVE PROCEDURE ACT
NOVEMBER 19 (legislative day, OCTOBER 29), 1945.—Ordered to be printed
Mr. McCARRAN, from the Committee on the Judiciary,
submitted the following
REPORT
[To accompany S. 7]
The Committee on the Judiciary, to whom was referred the bill
(S. 7), to improve the administration of justice by prescribing fair
administrative procedure, having considered the same, reports
favorably thereon, with an amendment, and recommend that the
bill do pass, as amended.
There is a widespread demand for legislation to settle and regu-
late the field of Federal administrative law and procedure. The
subject is not expressly mentioned in the Constitution, and there is
no recognizable body of such law, as there is for the courts in the
Judicial Code. There are no clearly recognized legal guides for
either the public or the administrators. Even the ordinary opera-
tions of administrative agencies are often difficult to know. The
Committee on the Judiciary is convinced that, at least in essentials,
there should be some simple and standard plan of administrative
procedure.
[P.I]
III. STRUCTURE OF THE BILL
The bill, as reported, is not a specification of the details of admin-
istrative procedure, nor is it a codification of administrative law.
Instead, out of long consideration and in the light of the studies
heretofore mentioned, there has been framed an outline of mini-
mum basic essentials. Figure 2 on page 9 diagrams the bill.
The bill is designed to afford parties affected by administrative
powers a means of knowing what their rights are and how they
may be protected. By the same token, administrators are provided
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1256 LEGAL COMPILATION—PESTICIDES
with a simple course to follow in making administrative determi-
nations. The jurisdiction of the courts is clearly stated. The bill
thus provides for public information, administrative operation, and
judicial review.
SUBSTANCE OF THE BILL.—What the bill does in substance may
be summarized under four headings:
1. It provides that agencies must issue as rules certain speci-
fied information as to their organization and procedure, and
also make available other materials of administrative law
(sec. 3).
2. It states the essentials of the several forms of admin-
istrative proceedings (sees. 4, 5, and 6) and the limitations on
administrative powers (sec. 9).
3. It provides in more detail the requirements for admin-
istrative hearings and decisions in cases in which statutes
require such hearings (sec. 7 and 8).
4. It sets forth a simplified statement of judicial review
designed to afford a remedy for every legal wrong (sec. 10).
The first of these is basic, because it requires agencies to take the
initiative in informing the public. In stating the essentials of the
different forms of administrative proceedings, it carefully dis-
tinguishes between the so-called legislative functions of admin-
istrative agencies (where they issue general regulations) and their
judicial functions (in which they determine rights or liabilities in
particular cases).
The bill provides quite different procedures for the "legislative"
and "judicial" functions of administrative agencies. In the "rule
making" (that is, "legislative") function it provides that, with
certain exceptions, agencies must publish notice and at least permit
interested parties to submit their views in writing for agency con-
sideration before issuing general regulations (sec. 4). No hearings
are required by the bill unless statutes already do so in a particular
case. Similarly, in "adjudications" (that is, the "judicial" function)
no agency hearings are required unless statutes already do so, but
in the latter case the mode of hearing and decision is prescribed
[P-7]
(sec. 5). Where existing statutes require that either general regu-
lations (called "rules" in the bill) or particularized adjudications
(called "orders" in the bill) be made after agency hearing or oppor-
tunity for such hearing, then section 7 spells out the minimum
requirements for such hearings, section 8 states how decisions shall
be made thereafter, and section 11 provides for examiners to pre-
side at hearings and make or participate in decisions.
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STATUTES AND LEGISLATIVE HISTORY 1257
While the administrative power and procedure provisions of sec-
tions 4 through 9 are law apart from court review, the provisions
for judicial review provide parties with a method of enforcing their
rights in a proper case (sec. 10). However, it is expressly provided
that the judicial review provisions are not operative where statutes
otherwise preclude judicial review or where agency action is by law
committed to agency discretion.
KINDS OF PROVISIONS.—The bill may be said to be composed of
five types of provisions:
1. Those which are largely formal such as the sections set-
ting forth the title (sec. 1), definitions (sec. 2), and rules of
construction (sec. 12).
2. Those which require agencies to publish or make avail-
able information on administrative law and procedure (sec. 3).
3. Those which provide for different kinds of procedures
such as rule making (sec. 4), adjudications (sec. 5), and mis-
cellaneous matters (sec. 6) as well as for limitations upon
sanctions and powers (sec. 9).
4. Those which provide more of the detail for hearings
(sec. 7) and decisions (sec. 8) as well as for examiners
(sec. 11).
5. Those which provide for judicial review (sec. 10).
The bill is so drafted that its several sections and subordinate
provisions are closely knit. The substantive provisions of the bill
should be read apart from the purely formal provisions and minor
functional distinctions. The definitions in section 2 are important,
but they do not indicate the scope of the bill since the subsequent
provisions make many functional distinctions and exceptions. The
public information provisions of section 3 are of the broadest
application because, while some functions and some operations
may not lend themselves to formal procedure, all administrative
operations should as a matter of policy be disclosed to the public
except as secrecy may obviously be required or only internal agency
"housekeeping" arrangements may be involved. Sections 4 and 5
prescribe the basic requirements for the making of rules and the
adjudication of particular cases. In each case, where other statutes
require opportunity for an agency hearing, sections 7 and 8 set
forth the minimum requirements for such hearings and the agency
decisions thereafter while section 11 provides for the appointment
and tenure of examiners who may participate. Section 6 prescribes
the rights of private parties in a number of miscellaneous respects
which may be incidental to rule making, adjudication, or the exer-
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1258 LEGAL COMPILATION—PESTICIDES
cise of any other agency authority. Section 9 limits sanctions, and
section 10 provides for judicial review. r 0,
[p. 8]
SEC. 10. JUDICIAL REVIEW.—Section 10 on judicial review does
not apply in any situation so far as there are involved matters with
respect to which statutes preclude judicial review or agency action
is by law committed to agency discretion.
Very rarely do statutes withhold judicial review. It has never
been the policy of Congress to prevent the administration of its
own statutes from being judicially confined to the scope of author-
ity granted or to the objectives specified. Its policy could not be
otherwise, for in such a case statutes would in effect be blank
checks drawn to the credit of some administrative officer or board.
The basic exception of matters committed to agency discretion
would apply even if not stated at the outset. If, for example, stat-
utes are drawn in such broad terms that in a given case there is no
law to apply, courts of course have no statutory question to review.
That situation cannot be remedied by an administrative procedure
act but must be treated by the revision of statutes conferring
administrative powers. However, where statutory standards,
definitions, or other grants of power deny or require action in given
situations or confine an agency within limits as required by the
Constitution, then the determination of the facts does not lie in
agency discretion but must be supported by either the administra-
tive or judicial record.
(a.) RIGHT OF REVIEW.—Any person suffering legal wrong be-
cause of any agency action, or adversely affected within the mean-
ing of any statute, is entitled to judicial review.
This subsection confers a right of review upon any person ad-
versely affected in fact by agency action or aggrieved within the
meaning of any statute. The phrase "legal wrong" means such a
wrong as is specified in subsection (e) of this section. It means
that something more than mere adverse personal effect must be
shown—that is, that the adverse effect must be an illegal effect.
The law so made relevant is not just constitutional law but any
and all applicable law.
[p. 26]
*******
JUDICIAL REVIEW
SEC. 10. Except so far as (1) statutes preclude judicial review or (2) agency
action is by law committed to agency discretion—
(a) Right of review.—Any person suffering legal wrong because of any
agency action, or adversely affected or aggrieved by such action within the
meaning of any relevant statute, shall be entitled to judicial review thereof.
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STATUTES AND LEGISLATIVE HISTORY 1259
(b) Form and venue of action.—The form of proceeding for judicial re-
view shall be any special statutory review proceeding relevant to the subject
matter in any court specified by statute or, in the absence or inadequacy there-
of, any applicable form of legal action (including actions for declaratory judg-
ments or writs of prohibitory or mandatory injunction or habeas corpus) in
any court of competent jurisdiction. Agency action shall be subject to judicial
review in civil or criminal proceedings for judicial enforcement except to the
extent that prior, adequate, and exclusive opportunity for such review is pro-
vided by law.
(c) Reviewable acts.—Every agency action made reviewable by statute
and every final agency action for which there is no other adequate remedy in
any court shall be subject to judicial review. Any preliminary, procedural, or
intermediate agency action or ruling not directly reviewable shall be subject
to review upon the review of the final agency action. Except as otherwise ex-
pressly required by statute, agency action shall be final whether or not there
has been presented or determined any application for a declaratory order, for
any form of reconsideration, or (unless the agency otherwise requires by rule)
for an appeal to superior agency authority.
(d) Interim relief.—Pending judicial review any agency is authorized
where it finds that justice so requires, to postpone the effective date of any
action taken by it. Upon such conditions as may be required and to the extent
necessary to prevent irreparable injury, every reviewing court (including
every court to which a case may be taken on appeal from or upon application
for certiorari or other writ to a reviewing court) is authorized to issue all
necessary and appropriate process to postpone the effective date of any agency
action or to preserve status or rights pending conclusion of the review pro-
ceedings.
(e) Scope of review.—So far as necessary to decision and where presented
the reviewing court shall decide all relevant questions of law, interpret con-
stitutional and statutory provisions, and determine the meaning or applica-
bility of the terms of any agency action. It shall (A) compel agency action
unlawfully withheld or unreasonably delayed; and (B) hold unlawful and set
aside agency action, findings, and conclusions found to be (1) arbitrary,
capricious, or otherwise not in accordance with law; (2) contrary to constitu-
tional right, power, privilege, or immunity; (8) in excess of statutory juris-
diction, authority, or limitations, or short of statutory right; (4) without
observance of procedure required by law; (5) unsupported by substantial
[p. 36]
evidence in any case subject to the requirements of sections 7 and 8 or other-
wise reviewed on the record of an agency hearing provided by statute; or
(6) unwarranted by the facts to the extent that the facts are subject to trial
de novo by the reviewing court. In making the foregoing determinations the
court shall review the whole record or such portions thereof as may be cited
by the parties, and due account shall be taken of the rule of prejudicial error.
[p. 37]
Section 10 (d) : The first sentence states existing law. The second sentence
may be said to change existing law only to the extent that the language of the
opinion in Scripps-Howard Radio, Inc. v. Federal Communications Commission
(316 U. S. 4, 14) may be interpreted to deny to reviewing courts the power to
permit an applicant for a renewal of a license to continue to operate as if the
original license had not expired, pending conclusion of the judicial review pro-
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1260 LEGAL COMPILATION—PESTICIDES
ceedings. In any event, the court must find, of course, that granting of interim
relief is necessary to prevent irreparable injury.
Section 10 (e): This declares the existing law concerning the scope of
judicial review. The power of the court to direct or compel agency action un-
lawfully withheld or unreasonably delayed is not intended to confer any non-
judicial function or to narrow the principle of continuous administrative
control enunciated by the Supreme Court in Federal Communications Com-
mission v. Pottsville Broadcasting Co. (309 U.S. 134). Clause (5) is intended
to embody the law as declared, for example, in Consolidated Edison Co. v.
National Labor Relations Board (305 U.S. 197). There the Chief Justice said:
"Substantial evidence is more than a mere scintilla. It means such relevant
evidence as a reasonable mind might accept as adequate to support a conclu-
sion (p. 229) * * * assurance of a desirable flexibility in administrative pro-
cedure does not go so far as to justify orders without a basis in evidence
having rational probative force" (p. 230).
The last sentence of this section makes it clear that not every failure to
observe the requirements of this statute or of the law is ipso facto fatal to the
validity of an order. The statute adopts the rule now well established as a
[p. 44]
matter of common law in all jurisdictions that error is not fatal unless
prejudicial.
Section 11: This section provides for the appointment, compensation, and
tenure of examiners who will preside over hearings and render decisions pur-
suant to sections 7 and 8. The section provides that appointments shall be
made "subject to the civil service and other laws to the extent not inconsistent
with this act." Appointments are to be made by the respective employing
agencies of personnel determined by the Civil Service Commission to be qual-
ified and competent examiners. The examiners appointed are to serve only as
examiners, except that, in particular instances (especially where the volume
of hearings under a given statute or in a given agency is not very great),
examiners may be assigned additional duties which are not inconsistent with
or which do not interfere with their duties as examiners. To insure equality of
participation among examiners in the hearing and decision of cases, the
agencies are required to use them in rotation so far as may be practicable.
Examiners are subject to removal only for good cause "established and
determined" by the Commission. The Commission must afford the examiner a
hearing, if requested, and must rest its decision solely upon the basis of the
record of such hearing. It should be noted that the hearing and the decision
are to be conducted and made pursuant to the provisions of sections 7 and 8.
Section 11 provides further that the Commission shall prescribe the com-
pensation of examiners, in accordance with the compensation schedules pro-
vided in the Classification Act, except that the efficiency rating system set
forth in that act shall not be applicable to examiners.
Section 12: The first sentence of section 12 is intended simply to indicate
that the act will be interpreted as supplementing constitutional and legal
requirements imposed by existing law.
The section further provides that "no subsequent legislation shall be held
to supersede or modify the provisions of this act except to the extent that such
legislation shall do so expressly." It is recognized that no congressional legisla-
tion can bind subsequent sessions of the Congress. The present act can be
repealed in whole or in part at any time after its passage. However, the act is
-------
STATUTES AND LEGISLATIVE HISTORY 1261
intended to express general standards of wide applicability. It is believed that
the courts should as a rule of construction interpret the act as applicable on a
broad basis, unless some subsequent act clearly provides to the contrary.
[p. 45]
1.16a(2) HOUSE COMMITTEE ON THE JUDICIARY
H.R. REP. No. 1980, 79th Cong., 2d Sess. (1946)
ADMINISTRATIVE PROCEDURE ACT
MAY 3, 1946.—Committed to the Committee of the Whole House on the State
of the Union and Ordered to be printed
Mr. WALTER, from the Committee on the Judiciary, submitted
the following
REPORT
[To accompany S. 7]
The Committee on the Judiciary, to whom was referred the
bill (S. 7) to improve the administration of justice by prescrib-
ing fair administrative procedure, having considered the same,
report the bill favorably to the House, with an amendment, with
the recommendation that, as amended, the bill do pass.
The committee amendment is as follows:
Strike out all of the bill after the enacting clause and insert in
lieu thereof the following:
TITLE
SECTION 1. This Act may be cited as the "Administrative Procedure Act".
*******
[p.l]
of this Act or other proceedings required by law and shall make its decision.
Except in cases of willfulness or those in which public health interest, or
safety requires otherwise, no withdrawal, suspension, revocation, or annul-
ment of any license shall be lawful unless prior to the institution of agency
proceedings therefor, facts or conduct which may warrant such action shall
have been called to the attention of the licensee by the agency in writing and
the licensee shall have been accorded opportunity to demonstrate or achieve
compliance with all lawful requirements. In any case in which the licensee has
in accordance with agency rules made timely and sufficient application for a
renewal or a new license, no license with reference to any activity of a con-
tinuing nature shall expire until such application shall have been finally
determined by the agency.
JUDICIAL REVIEW
SEC. 10. Except so far as (1) statutes preclude judicial review or (2)
agency action is by law committed to agency discretion—
(a.) RIGHT OF REVIEW.—Any person suffering legal wrong because of any
agency action, or adversely affected or aggrieved by such action within the
meaning of any relevant statute, shall be entitled to judicial review thereof.
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1262 LEGAL COMPILATION—PESTICIDES
(b) FORM AND VENUE OF ACTION.—The form of proceeding for judicial re-
view shall be any special statutory review proceeding relevant to the subject
matter in any court specified by statute or, in the absence or inadequacy
thereof, any applicable form of legal action (including actions for declaratory
judgments or writs of prohibitory or mandatory injunction or habeas corpus)
in any court of competent jurisdiction. Agency action shall be subject to judi-
cial review in civil or criminal proceedings for judicial enforcement except
to the extent that prior, adequate, and exclusive opportunity for such review
is provided by law.
(c) REVIEWABLE ACTS.—Every agency action made reviewable by statute
and every final agency action for which there is no other adequate remedy
in any court shall be subject to judicial review. Any preliminary, procedural,
or intermediate agency action or ruling not directly reviewable shall be subject
to review upon the review of the final agency action. Except as otherwise
expressly required by statute, agency action otherwise final shall be final for
the purposes of this subsection whether or not there has been presented or
determined any application for a declaratory order, for any form of recon-
sideration, or (unless the agency otherwise requires by rule and provides that
the action meanwhile shall be inoperative) for an appeal to superior agency
authority.
(d) INTERIM RELIEF.—Pending judicial review any agency is authorized,
where it finds that justice so requires, to postpone the effective date of any
action taken by it. Upon such conditions as may be required and to the extent
necessary to prevent irreparable injury, every reviewing court (including
every court to which a case may be taken on appeal from or upon application
for certiorari or other writ to a reviewing court) is authorized to issue all
necessary and appropriate process to postpone the effective date of any agen-
cy action or to preserve status or rights pending conclusion of the review
proceedings.
(c) SCOPE OF REVIEW.—So far as necessary to decision and where presented
the reviewing court shall decide all relevant questions of law, interpret con-
stitutional and statutory provisions, and determine the meaning or applica-
bility of the terms of any agency action. It shall (A) compel agency action
unlawfully withheld or unreasonably delayed; and (B) hold unlawful and
set aside agency action, findings, and conclusions found to be (1) arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law;
(2) contrary to constitutional right, power, privilege, or immunity; (3) in
excess of statutory jurisdiction, authority, or limitations, or short of statutory
rights; (4) without observance of procedure required by law; (5) unsupported
by substantial evidence in any case subject to the requirements of sections
7 and 8 or otherwise reviewed on the record of an agency hearing provided
by statute; or (6) unwarranted by the facts to the extent that the facts are
subject to trial de novo by the reviewing court. In making the foregoing deter-
minations the court shall review the whole record or such portions thereof as
may be cited by any party, and the account shall be taken of the rate of judi-
cial error.
EXAMINEES
SEC. 11. Subject to the civil-service and other laws to the extent not incon-
sistent with this Act, there shall be appointed by and for each agency as many
qualified and competent examiners as may be necessary for proceedings per-
tinent to sections 7 and 8 who shall be assigned to cases in rotation so far as
practicable.
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STATUTES AND LEGISLATIVE HISTORY 1263
SECTION 10 (D) . TEMPORARY RELIEF PENDING FULL REVIEW
Pending judicial review any agency may postpone the effective
date of its action. Upon conditions and as may be necessary to
prevent irreparable injury, any reviewing court may postpone
the effective date of any agency action or preserve the status quo
pending conclusion of review proceedings.
This section permits either agencies or courts, if the proper
showing be made, to maintain the status quo. The section is in
effect a statutory extension of rights pending (judicial review,
although the reviewing court must order the extension; or, to put
the situation another way, status authorizing agency action are
to be construed to extend rights pending judicial review and the
exclusiveness of the administrative remedy is diminished so far
as this section operates. While the section would not permit a
court to grant an initial license, it provides intermediate judicial
relief for every other situation in order to make judicial review
effective. The authority granted is equitable and should be used
by both agencies and courts to prevent irreparable injury or afford
parties an adequate judicial remedy. Such relief would normally,
if not always, be limited to the parties complainant and may be
withheld in the absence of a substantial question for review. In
determining whether agency action should be postponed, the
court should take into account that persons other than parties
[p. 43]
may be adversely affected by such postponement and in such cases
the party seeking postponement may be required to furnish
security to protect such other persons from loss resulting from
postponement.
SECTION 10 (E). SCOPE OF COURT REVIEW
Reviewing courts are required to decide all relevant questions
of law, interpret constitutional and statutory provisions, and
determine the meaning or applicability of any agency action.
They must (A) compel action unlawfully withheld or unreasonably
delayed and (B) hold unlawful any action, findings, or conclusions
found to be (1) arbitrary or an abuse of discretion, (2) contrary
to the Constitution, (3) contrary to statutes or statutory right,
(4) without observance of procedure required by law, (5) unsup-
ported by substantial evidence in any case reviewed upon the
record of an agency hearing provided by statute, or (6) unwar-
ranted by the facts so far as the latter are subject to trial de novo.
In making these determinations the court is to consider the whole
record or such parts as any party may cite, and due account must
be taken of the rule of prejudicial error.
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1264 LEGAL COMPILATION—PESTICIDES
This section provides that questions of law are for courts rather
than agencies to decide in the last analysis and it also lists the
several categories of questions of law. Under it courts are required
to determine the application or threatened application or ques-
tions respecting the validity or terms of any agency action not-
withstanding the form of the proceeding or whether brought by
private parties for review or by public officers or others for
enforcement. It expressly recognizes the right of properly inter-
ested parties to compel agencies to act where they improvidently
refuse to act. "Finding" and "conclusion" also mean failure to
find or conclude as the law and the record may require. "Accord-
ance with law" requires, among other things, a judicial determina-
tion of the authority or propriety of interpretative rules and
statements of policy. "Short of statutory right" means that agen-
cies are not authorized to give partial relief where a party demon-
strates his right to the whole. Authorized relief must be granted
by an agency to the full extent that entitlement is shown.
"Without observance of procedure required by law" means not
only the procedures required and procedural rights conferred by
this bill but any other procedures or procedural rights the law
may require. Except in a few respects, this is not a measure con-
ferring administrative powers but is one laying down definitions
and stating limitations. These definitions and limitations must,
to be sure, be interpreted and applied by agencies affected by
them in the first instance. But the enforcement of the bill, by the
independent judicial interpretation and application of its terms,
is a function which is clearly conferred upon the courts in the
final analysis. It will thus be the duty of reviewing courts to pre-
vent avoidance of the requirements of the bill by any manner or
form of indirection, and to determine the meaning of the words
and phrases used. For example, in several provisions the expres-
sion "good cause" is used. The cause so specified must be inter-
preted by the context of the provision in which it is found and
the purpose of the entire section and bill. Cause found must be
real and demonstrable. If the agency is proceeding upon a statu-
tory hearing and record, the cause will appear there; otherwise
it must be such that the agency may show the facts and considera-
[p. 44]
tions warranting the finding in any proceeding in which the find-
ing is challenged. The same would be true in the case of findings
other than of good cause, required in the bill. As has been said,
these findings must in the first instance be made by the agency
concerned but, in the final analysis, their propriety in law and on
-------
STATUTES AND LEGISLATIVE HISTORY 1265
the facts must be sustainable upon inquiry by a reviewing court.
"Substantial evidence" means evidence which on the whole
record is clearly substantial, plainly sufficient to support a finding
or conclusion under the requirements of section 7 (c), and mater-
ial to the issues. It is exceedingly important. Difficulty has come
about by the practice of agencies and courts to rely upon some-
thing less—suspicion, surmise, implications, or plainly incredible
evidence. Although the agency must do so in the first instance,
under this bill it will be the duty of the courts to determine in the
final analysis and in the exercise of their independent judgment
whether on the whole of the proofs brought to their attention the
evidence in a given instance is sufficiently substantial to support
a finding, conclusion, or other agency action or inaction. In review-
ing a case under this fifth category the court must base its judg-
ment upon its own review of the entire record or so much thereof
as may be cited by any party.
*******
[p. 45]
JUDICIAL REVIEW
SEC. 10. Except so far as (1) statutes preclude judicial review or (2)
agency action is by law committed to agency discretion—
(a) RIGHT OF REVIEW.—Any person suffering legal wrong because of any
agency action, or adversely affected or aggrieved by such action within the
meaning of any relevant statute, shall 'be entitled to judicial review thereof.
(b) FORM AND VENUE OF ACTION.—The form of proceeding for judicial
review shall be any special statutory review proceeding relevant to the sub-
ject matter in any court specified by statute or, in the absence or inadequacy
thereof, any applicable form of legal action (including actions for declara-
tory judgments or writs of prohibitory or mandatory injunction or habeas
corpus) in any court of competent jurisdiction. Agency action shall be sub-
ject to judicial review in civil or criminal proceedings for judicial enforce-
[p. 54]
ment except to the extent that prior, adequate, and exclusive opportunity for
such review is provided by law.
(c) REVIEWABLE ACTS.—Every agency action made reviewable by statute
and every final agency action for which there is no other adequate remedy in
any court shall be subject to judicial review. Any preliminary, procedure, or
intermediate agency action or ruling not directly reviewable shall be subject
to review upon the review of the final agency action. Except as otherwise
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1266 LEGAL COMPILATION—PESTICIDES
expressly required by statute, agency action otherwise final shall be final for
the purposes of this subsection whether or not there has been presented or
determined any application for a declaratory order, for any form of recon-
sideration, or (unless the agency otherwise requires by rule and provides
that the action meanwhile shall be inoperative for an appeal to superior agen-
cy authority.21
(d) INTERIM RELIEF.—Pending judicial review any agency is authorized,
where it finds that justice so requires, to postpone the effective date of any
action taken by it. Upon such conditions as may be required and to the extent
necessary to prevent irreparable injury, every reviewing court (including
every court to which a case may be taken on appeal from or upon application
for certiorari or other writ to a reviewing court) is authorized to issue all
necessary and appropriate process to postpone the effective date of any agen-
cy action or to preserve status or rights pending conclusion of the review
proceedings.
(e) SCOPE OF REVIEW.—So far as necessary to decision and where presented
the reviewing court shall decide all relevant questions of law, interpret con-
stitutional and statutory provisions, and determine the meaning or applica-
bility of the terms of any agency action. It shall (A) compel agency action
unlawfully withheld or unreasonably delayed; and (B) hold unlawful and set
aside agency action, findings, and conclusions found to be (1) arbitrary, capri-
cious, an abuse of discretion,22 or otherwise not in accordance with law; (2)
contrary to constitutional right, power, privilege, or immunity; (3) in excess
of statutory jurisdiction, authority, or limitations, or short of statutory right;
(4) without observance of procedure required by law; (5) unsupported by
substantial evidence in any case subject to the requirements of section 7 and 8
or otherwise reviewed on the record of an agency hearing provided by stat-
ute; or (6) unwarranted by the facts to the extent that the facts are sub-
ject to trial de novo by the reviewing court. In making the foregoing determi-
nations the court shall review the whole record or such portions thereof as
may be cited by [the parties] any party,23 and due account shall be taken of
the rule of prejudicial error.
[p. 55]
21 The change is made to clarify the provision by making specifically the language of the
bill the explanation given in the Senate Committee report (p. 27). It should be noted that
section 8 (a) permits agencies to provide by rule for appeals to them from initial decisions of
examiners. That provision, as well as this provision of section 10 (c), would authorize an
agency to adopt rules requiring a party to take a timely appeal to the agency before resorting
to the courts. A party cannot wilfully fail to exhaust his administrative remedies and then, after
the agency action has become operative, either secure a suspension of the agency action by a
belated appeal to the agency, or resort to court without having given the agency an opportunity
to determine the questions raised. If he so fails he is precluded from judicial review by the
application of the time-honored doctrine of exhaustion of administrative remedies. This is not
to say that after the right to an administrative appeal has lapsed an agency may not, on proper
application, either reconsider an adjudication or receive proposals for the modification of a
rule, with or without suspending the operation of the agency action involved.
22 The change is designed to make it clear that S. 7 preserves judicial review of abuses of
discretion.
23 This change is to conform the language with the similar provision in sec. 7(c).
-------
STATUTES AND LEGISLATIVE HISTORY
1267
1.16a(3) CONGRESSIONAL RECORD, VOL. 92 (1946)
1.16a(3)(a) March 12: Amended and passed Senate, pp. 2151,
2153,2158,2166
with the construction which I place on
the term:
Mr. McCARRAN.
*****
Five types of provisions compose
this bill. They are:
First. Provisions which are largely
formal, such as the sections setting
forth the title, definitions, and rules of
construction.
Second. Provisions which require
agencies to publish or make available
information on administrative law and
procedure.
Third. Provisions for different kinds
of procedures such as rule-making, ad-
judications, and miscellaneous matters,
as well as for limitations upon sanc-
tions and powers.
Fourth. Provisions concerning the
detail for hearings and decisions as
well as for examiners.
Fifth. Provisions for judicial review.
I desire to emphasize the fifth type
of provisions, namely, provisions for
judicial review, because it is something
in which the American public has been
and is much concerned, harkening
back, if we may, to the Constitution of
the United States, which sets up the
judicial branch of the Government for
the redress of human wrongs and for
the enforcement of human rights.
[p. 2151]
Mr. McCARRAN. I have not in mind
the language to which the able Senator
refers, but the language as I heard
him read it is rather common language
addressing itself to that subject. My
conception of the term "legal wrong"
is set forth in the committee report on
page 26:
The phrase "legal wrong" means such a
wrong as is specified in subsection (e) of this
section. It means that something: more than
mere adverse personal effect must be shown—
that is, that the adverse effect must be an illegal
effect. The law so made relevant is not just con-
stitutional law, but any and all applicable law.
Let me read further in connection
Reviewing courts are required to decide all
relevant questions of law, interpret constitu-
tional and statutory provisions, and determine
the meaning or applicability of any agency
action. They must (A) compel action unlawfully
withheld or unreasonably delayed and (B) hold
unlawful any action, findings, or conclusions
found to be (1) arbitrary, (2) contrary to the
Constitution, (3) contrary to statutes or short
of statutory right, (4) without observance of
procedure required by law, (5) unsupported by
substantial evidence upon the administrative
record where the agency is authorized by statute
to hold hearings subject to sections 7 and 8, or
(6) unwarranted by the facts so far as the
latter are subject to trial de novo.
I have tried to anticipate the ques-
tion which the able Senator has pro-
pounded to me. I am glad that he asked
the question. I have tried to define the
term, because I thought it might be
well to have it defined in the RKCORD.
Mr. AUSTIN. Mr. President, will
the Senator further yield ?
Mr. McCARRAN. I yield.
Mr. AUSTIN. I see.the application
of what the distinguished Senator has
just stated to the following part of the
clause in section 10 (a) namely, "or
adversely affected or aggrieved by such
action within the meaning of any rele-
vant statute." That is another category
of men and women who are entitled to
review. But my question was limited to
the category described as "any person
suffering legal wrong because of any
agency action." On this point I should
like to read further from the definition
of "wrong," because this is a new use
of the word. If the author of the bill
intends by the use of the term "legal
wrong" what is here set forth, I should
like to have it in the RECORD, because it
would save a great deal of contro-
versy. May I take the time of the Sena-
tor to read further from the definition
of "wrong" in Bouvier's Law Diction-
ary?
-------
1268
LEGAL COMPILATION—PESTICIDES
Mr. McCARRAN. Yes; I should like
to have the Senator read it.
Mr. AUSTIN. The definition is as
follows:
Wrong. An injury; a tort; a violation of
right.
In its broad sense, it includes every injury to
another, independent of the motive causing the
injury (Union Pae. Ry. Co. v. Henry (36 Kan.
670. HPac. 1)J.
A wrong is an invasion of right to the damage
of the party who suffers it. It consists in the
injury done, and not commonly in the purpose
or mental or physical capacity of the person or
agent doing it. It may or may not have been
done with bad motive; the question of motive is
usually a question of aggravation only (Wil~
Hams v. Hays (143 N. Y. 417, 38 N.E. 449, 26
L. R. A. 153, 42 Am. St. Rep. 743)).
In its most usual sense, wrong signifies an
injury committed to the person or property of
another, or to his relative rights unconnected
with contract; and these wrongs are committed
with or without force. But in a more extended
signification, wrong includes the violation of a
contract; a failure by a man to perform his
undertaking or promise is a wrong or injury to
him to whom it was made (3 Bla. Com. 168).
A public wrong is an act which is injurious
to the public generally, commonly known by the
name of crime, misdemeanor, or offense; and
it ia punishable in various ways, such as indict-
ments, summary proceedings and, upon con-
viction, by death, imprisonment, fine, etc.
Private wrongs, which are injuries to indi-
viduals, unaffecting the public; these are re-
dressed by actions for damages, etc. See Reme-
dies ; Tort.
For a classification of wrongs, see Holland,
Jurisprudence 270.
The combination of words used here
is very significant. The adjective
"legal" is a limiting adjective; and, as
it has been applied in jurisprudence to
"injury," it is defined as follows in
Words and Phrases, fourth series,
second volume, page 548:
"Legal injury" must be violation of some
legal right and id distinct from "damage,"
which is harm, or loss, sustained by injury
(Combs v. Harais Bank & Trust Co. (27 S. W.
(2d) 956, 966, 234 Ky. 202)).
For the sake of the future of those
practicing under this estimable bill,
I think it would be well to have the
RECORD show whether the distinguished
author of the bill regards the category
of persons entitled to review which is
here described, that is, "any person
suffering legal wrong," as any person
who has suffered in the manner de-
scribed in the quotation from Bouvier's
Law Dictionary.
Mr. McCARRAN. Taking Bouvier
and Words and Phrases combined, and
taking the decisions of the courts of
last resort, to whose language we have
access, I should answer the Senator
"yes." That is, I take into consideration
all the definitions which apply to define
that term, and I respectfully refer to
the committee report, which I read a
moment ago. It means that something
more than mere adverse personal effect
must be shown; that is, that the adverse
effect must be an illegal effect. So, to
Bouvier, to Words and Phrases, and to
the decisions to which the able Senator
refers, I also add the expression con-
tained in the committee report.
Mr. AUSTIN. I thank the Senator.
Mr. McCARRAN. Let me go a little
further, because I am very grateful to
the Senator for bringing up this ques-
tion. We asked the Attorney General
and the Department of Justice to com-
ment on this bill. I now read to the
Senate the Attorney General's com-
ment :
Section 10 (a) : Any person suffering legal
wrong because of any agency action, or ad-
versely affected or aggrieved by such action
within the meaning of any relevant statute,
shall be entitled to judicial review of such
action. This reflects existing law. In Alabama
Power Co. v. Ickes (302 U. S. 404), the Supreme
Court stated the rule concerning persons en-
titled to judicial review. Other cases having
an important bearing on this subject are:
Massachusetts v. Mellon (262 U.S. 447), The
Chicago Junction Case (264 U. S. 258), Sprunt
& Son v. United States (281 U. S. 249), and
Perkins v. Lukens Steel Co. (310 U. S. 113).
An important decision interpreting the mean-
ing of the terms "aggrieved" and "adversely
affected" is Federal Communications Commis-
sion v. Sanders Bros. Radio Station (309 U.S.
470).
Mr. President, I have referred the
Senator to that expression coming
from the Attorney General, in connec-
tion with this bill, to indicate to him and
to the Senate the meticulous study
which we have tried to give to this bill,
so that we may construe the terms in
such a way that there may be no diver-
-------
STATUTES AND LEGISLATIVE HISTORY
1269
gence of views when we get through.
I realize that the layman says this
is an intricate bill. In a way it is, and
yet in a way it simplifies itself in
practice.
[p. 2153]
Mr. McCARRAN.
Section 10 is the section which re-
lates to judicial review. This section
does not apply in any situation so far
as there are involved matters with
respect to which existing statutes pre-
clude judicial review, or with respect
to which agency action is by lav/ com-
mitted to agency discretion.
Subsection (a) of section 10 provides
that any person suffering legal wrong
because of any agency action, or ad-
versely affected within the meaning of
any statute, is entitled to judicial re-
view.
Subsection (b) of section 10 con-
cerns the form and venue of action. It
provides that the technical form of
proceeding for judicial review is any
special proceeding provided by statute,
or, in the absence or inadequacy thereof,
any relevant form of legal action, such
as those for declaratory judgments or
injunctions, in any court of competent
jurisdiction. Furthermore, under this
subsection, agency action is also made
subject to judicial review in any civil
or criminal proceeding for enforce-
ment, except to the extent that prior,
adequate, and exclusive opportunity
for such review is provided by law.
Subsection (c) of section 10 con-
cerns reviewable acts of agencies. This
subsection provides that agency action
made reviewable specially by statute,
or final agency action for which there
is no other adequate judicial remedy,
is subject to judicial review. In addi-
tion, preliminary or procedural mat-
ters not directly subject to review are
made reviewable upon the review of
final actions. Except as statutes may
expressly require otherwise, agency
action is final regardless of whether
there has been presented or determined
any application for a declaratory order,
for any form of reconsideration, or
unless the agency otherwise requires
by rule, for an appeal to superior
agency authority.
Subsection (d) of section 10 con-
cerns interim relief. It provides that
pending judicial review, any agency
may postpone the effective date of its
action. Upon conditions, and as may
be necessary to prevent irreparable
injury, any reviewing court may post-
pone the effective date of any agency
action, or preserve the status quo pend-
ing conclusion of review proceedings.
Subsection (e) of section 10 concerns
the scope of review. Under this subsec-
tion, reviewing courts are required to
decide all relevant questions of law,
interpret constitutional and statutory
provisions, and determine the meaning
or applicability of any agency action.
Such courts are required to compel
action shown to be unlawfully withheld
or unreasonably delayed. They are re-
quired to hold unlawful any action,
findings, or conclusions found to be
either arbitrary or contrary to the
Constitution or contrary to statutes or
short of statutory right or without
observance of procedure required by
law or unsupported by substantial evi-
dence upon the administrative record,
where the agency is authorized by
statute to hold hearings subject to
sections 7 and 8, or unwarranted by
the facts insofar as the latter are
subject to trial de novo. In making
these determinations the court is to
consider the whole record or such parts
as the parties may cite, and due ac-
count must be taken of the rule of
prejudicial error.
Lp.2158 J
JUDICIAL REVIEW
SEC. 10. Except so far as (1) statutes pre-
clude judicial review or (2) agency action is by
law committed to agency discretion—
(a) Right of review: Any person suffering
legal wrong because of any agency action, or
adversely affected or aggrieved by such action
within the meaning of any relevant statute,
shall be entitled to judicial review thereof.
-------
1270
LEGAL COMPILATION—PESTICIDES
(b) Form and venue of action: The form of
proceeding for judicial review shall be any spe-
cial statutory review proceeding relevant to the
subject matter in any court specified by statute
or in the absence or inadequacy thereof, any
applicable form of legal action (including ac-
tions for declaratory judgments or writs of
prohibitory or mandatory injunction or habeas
corpus) in any court of competent jurisdiction.
Agency action shall be subject to judicial review
in civil or criminal proceedings for judicial
enforcement except to the extent that prior,
adequate, and exclusive opportunity for such
review is provided by law.
(c) Reviewable acts: Every agency action
made reviewable by statute and every final
agency action for which there is no other ade-
quate remedy in any court shall be subject to
judicial review. Any preliminary, procedural, or
intermediate agency action or ruling not di-
rectly reviewable shall be subject to review upon
the review of the final agency action. Except as
otherwise expressly required by statute, agency
action shall be final whether or not there has
been presented or determined any application
for a declaratory order, for any form of recon-
sideration, or (unless the agency otherwise re-
quires by rule) for an appeal to superior agency
authority.
(d) Interim relief: Pending judicial review
any agency is authorized, where it finds that
justice so requires, to postpone the effective date
of any action taken by it. Upon such conditions
as may be required and to the extent necessary
to prevent irreparable injury, every reviewing
court (including every court to which a case
may be taken on appeal from or upon applica-
tion for certiorari or other writ to a reviewing
court) is authorized to issue all necessary and
appropriate process to postpone the effective
date of any agency action or to preserve status
or rights pending conclusion of the review pro-
ceedings.
(e) Scope of review: So far as necessary to
decision and where presented the reviewing
court shall decide all relevant questions of law,
interpret constitutional and statutory provi-
sions, and determine the meaning or applic-
ability of the terms of any agency action. It
shall (A) compel agency action un 1 awfully
withheld or unreasonably delayed; and (B)
hold unlawful and set aside agency action, find-
ings and conclusions found to be (1) arbitrary,
capricious, or otherwise not in accordance with
law ; (2) contrary to constitutional right, power,
privilege, or immunity; (3) in excess of statu-
tory jurisdiction, authority, or limitations, or
short of statutory right; (4) without observance
of procedure required by law: (5) unsupported
by substantial evidence in any case subject to
the requirements of sections 7 and 8 or other-
wise reviewed on the record of an agency hear-
ing provided by statute; or (6) unwarranted by
the facts to the extent that the facts are subject
to trial de novo by the reviewing court. In
making the foregoing determinations the court
shall review the whole record or such portions
thereof as may be cited by the parties, and due
account shall be taken of the rule of prejudicial
[p. 2166]
1.16a(3)(b) May 24: Debated, amended and passed House, pp.
5454-5457,5660,5666
Mr. SABATH. The first exempts all matters so far as
statutes preclude judicial review. Con-
gress has rarely done so. Legislative
intent to forbid judicial review must
be, if not specific and in terms at least
clear, convincing, and unmistakable
under this bill. The mere fact that
Congress has not expressly provided
for judicial review would be completely
immaterial—see Stark v. Wickard (321
U.S. 288 at p. 317).
The second general limitation on the
section is that there are exempted mat-
ters to the extent that they are by law
committed to the absolute discretion of
administrative agencies. There have
been much misunderstanding and con-
fusion of terms respecting the discre-
tion of agencies. They do not have
JUDICIAL REVIEW, SECTION 10
Section 10 is a comprehensive state-
ment of the right, mechanics, and
scope of judicial review. It requires an
effective, just, and complete determina-
tion of every case and every relevant
issue. It is a means of enforcing all
forms of law and all types of legal
limitations. Every form of statutory
right or limitation would thus be sub-
ject to judicial review under the bill.
It would not be limited to constitu-
tional rights or limitations alone—See
Perkins v. Lukens Steel Co. (310 U.S.
113).
Two general exceptions are made in
the introductory clause of section 10.
-------
STATUTES AND LEGISLATIVE HISTORY
1271
authority in any case to act blindly or
arbitrarily. They may not willfully act
or refuse to act. Although like trial
courts they may determine facts in the
first instance and determine conflicting
evidence, they cannot act in disregard
of or contrary to the evidence or with-
out evidence. They may not take affir-
mative or negative action without the
factual basis required by the laws
under which they are proceeding. Of
course, they may not proceed in dis-
regard of the Constitution, statutes,
or other limitations recognized by law.
RIGHT OF REVIEW, SECTION 10 (A)
The first subsection of section 10
provides that any person suffering
legal wrong because of any agency
action, or adversely affected within the
meaning of any statute, is entitled to
judicial review. Legal wrong means
action of inaction in violation of the
law or the facts. The categories of
questions of legal wrong are set forth
later as subsection (e) of section 10.
FORMS OF REVIEW ACTIONS,
SECTION 10 (B)
Under this bill the technical form of
proceeding for judicial review is, first,
any special proceeding which Congress
has provided or, in the absence or in-
adequacy thereof, any relevant form
of action such as those for declaratory
judgments or injunctions in any court
of competent jurisdiction. In addition,
any agency action is also subject to
judicial review in any civil or criminal
enforcement proceeding except to the
extent that prior, adequate, and ex-
clusive opportunity for such review is
otherwise provided by law.
These provisions summarize the situ-
ation as it is now generally under-
stood. The section does not disturb
special proceedings which Congress
has provided, nor does it disturb the
venue arrangements under existing
law. It does, however, constitute a
statutory adoption of traditional forms
of action in cases where Congress has
made no contrary provision for judicial
review.
REVIEWABLE ACTS, SECTION 10 (C)
In any proceeding for judicial re-
view, the parties who seek it must
specify what it is they wish reviewed
and what it is they claim to be review-
able. Accordingly, secton 10 (c) pro-
vides that specific acts which are either
expressly made reviewable by legisla-
tion or for which there is no other
adequate judicial remedy are subject
to review under section 10 of this bill.
Preliminary or procedural matters not
so reviewable may be reviewed in con-
nection with final actions. An act is
final whether or not there has been pre-
sented or determined an application
for any form of reconsideration, unless
statutes otherwise expressly require.
The provisions of this section are
technical but involve no departure
from the usual and well understood
rules of procedure in this field.
TEMPORARY RELIEF, SECTION 10 (D>
Of importance in the field of judicial
review is the authority of courts to
grant temporary relief pending final
decision of the merits of a judicial-
review action. Accordingly section 10
(d) provides that any agency may
itself postpone the effective date of its
action pending judicial review or, upon
conditions and as may be necessary to
prevent irreparable injury, reviewing
courts may postpone the effective date
of contested action or preserve the
status quo pending conclusion of
judicial-review proceedings.
The section is a definite statutory
statement and extension of rights
pending judicial review. It thus, so far
as necessary, amends statutes confer-
ring exclusive authority upon adminis-
trative agencies to take or withhold
action. Its operation will involve no
radical departures from what has
generally been regarded as an essential
and inherent right of the courts; but,
however that may be, this provision
confers full authority to courts to pro-
-------
1272
LEGAL COMPILATION—PESTICIDES
tect the review process and purpose
otherwise expressed in section 10.
SCOPE OF REVIEW, SECTION 10 (E)
The final subsection of section 10
states the extent or degree of review
which courts are required to afford un-
der this bill. I have already referred
to the exemption of situations in which
Congress has specifically withheld re-
view or in which action has by law been
committed to the absolute discretion of
administrative agencies.
Subsection (e) of section 10 requires
courts to determine independently all
relevant questions of law, including the
interpretation of constitutional or stat-
utory provisions and the determination
of the meaning or applicability of any
agency action. They must compel ac-
tion unlawfully withheld or unreason-
ably delayed. They must hold unlawful
any action, findings or conclusions
which they find to be, first, arbitrary
or in abuse of discretion; second, con-
trary to any provision of the Consti-
tution; third, in violation of statutes
or statutory rights; fourth, without ob-
servance of procedure required by law;
fifth, unsupported by substantial evi-
dence in any case reviewed upon the
record of an agency hearing provided
by statute; or, sixth, unwarranted by
the facts so far as the latter are sub-
ject to trial de novo. In making these
determinations the court is to consider
the whole record or such parts as any
party may cite and, where error has
been fully cured prior to the effective
date of agency action, the courts may
apply the rule respecting nonprejudi-
cial error.
The term "substantial evidence" as
used in this bill means evidence which
on the whole record as reviewed by the
court and in the exercise of the inde-
pendent judgment of the reviewing
court is material to the issues, clearly
substantial, and plainly sufficient to
support a finding or conclusion affirma-
tive or negative in form under the re-
quirements of section 7 (c) heretofore
[p.5654]
discussed. Under this section the func-
tion of the courts is not merely to search
the record to see whether it is barren of
any evidence, or lacking any vestige of
reliable and probative evidence, or sup-
ports the agency action by a scintilla
or by mere hearsay, rumor, suspicion,
speculation, and inference—cf. Edison
Co. v. Labor Board (305 U. S. 197,
229-230). Under this bill it will not be
sufficient for the court to find, as the
late Chief Justice Stone pointed out
within the year, merely that there is
some "tenuous support of evidence"—
Bridges v. Wixon (326 U. S. at 178).
Nor may the bill be construed as per-
mitting courts to accept the judgments
of agencies upon unbelievable or in-
credible evidence.
Where there is no statutory admin-
istrative hearing to which review is
confined, the facts pertinent to any rel-
evant question of law must, of course,
be tried and determined de novo by the
reviewing court.
Whether a court is proceeding upon
an administrative or a judicial record,
the requirement of review upon the
whole record means that courts may
not look only to the case presented by
one of the parties but must decide upon
all of the proofs submitted.
[p.5655]
Mr. GWYNNE of Iowa.
*****
The only other and remaining fea-
ture I would like to mention has to do
with appeals, then I shall be glad to
yield. The great difficulty with our
present setup is that many of these
agencies are not subject to court re-
view and many of them even if we pass
this bill will still not be subject to
court review. This bill does not give a
court review in any case where review
is now precluded by statute. It simply
clarifies and expands in some particu-
lars the authority of the court in re-
viewing cases in which court review
is not precluded by law. In general they
can reverse or modify the judgment on
these grounds:
-------
STATUTES AND LEGISLATIVE HISTORY
1273
First. If the finding is contrary to
some provision of the Constitution;
Second. If the tribunal or agency has
failed to follow the procedure provided
by law;
Third. If the decision is arbitrary or
capricious; and
Finally, and very important, if the
finding of the agency is not supported
by substantial evidence.
[p.5656]
Mr. SPRINGER.
The gentleman from Iowa [Mr.
GWYNNE] has gone rather carefully
over the provisions of the bill. I desire
to call attention to only one, and that
is the fourth provision, relating to the
question of reviewable acts, the review
of the proceedings by the judiciary,
and the scope of the review. Under the
present procedure, in many cases
where there is any evidence, even a
scintilla of evidence, decisions have
been rendered and predicated on that
character of evidence before the hear-
ing tribunal.
Mr. HANCOCK. Even though con-
trary to the preponderance of the evi-
dence.
Mr. SPRINGER. Yes, as the distin-
guished gentleman from New York
says, that has been done in many cases
even though it is contrary to the pre-
ponderance of the evidence introduced
at the hearing.
May I say further on this particular
point that in many instances the evi-
dence upon which a decision has been
predicated has not been competent evi-
dence.
The bill pending before this commit-
tee, and which I hope will be passed
without a dissenting vote, provides for
judicial review in certain instances,
and it takes up the scope of the review.
It is to that particular feature that I
desire to address the few comments I
have to make upon this measure.
Page 39 of the bill provides that un-
der this law the reviewing courts "shall
compel agency action unlawfully with-
held or unreasonably delayed."
In many of those cases there has
been a withholding or a long delay, and
that particular feature is intended to
hasten action on the part of these agen-
cies. I feel confident each Member will
approve that provision in this bill.
The second provision, to which I now
refer, provides "and hold unlawful
and set aside agency action, findings,
and conclusions found to be arbitrary,
capricious, an abuse of discretion, or
otherwise not in accordance with law."
To my mind, that is a most potent
statement and is a fair and equitable
provision of the bill.
Mr. SCRIVNER. Mr. Chairman, will
the gentleman yield?
Mr. SPRINGER. I am happy to yield
to my friend from Kansas.
Mr. SCRIVNER. Does the gentle-
man feel that that would correct the
evils that might exist where a regula-
tion was contrary to the intent, spirit,
or purpose of the act?
Mr. SPRINGER. I think, unques-
tionably, it would. The gentleman is
precisely correct. That is the purpose
and that is the intention of that provi-
sion which has been written into this
bill. In those cases where these deci-
sions are found to be arbitrary, where
the decision is found to be capricious
or an abuse of discretion or otherwise
not in accordance with the law, the de-
cision can be set aside. That is certainly
fair, that is certainly equitable, and
that is certainly based upon a sound
philosophy.
The next provision under the scope
of review to which I desire to call the
attention of the Members is that any
decision can be set aside which is con-
trary to constitutional right, power,
privilege, or immunity. There is no one
in the world who could object to a pro-
vision of that kind because that is
based upon the sound philosophy of the
law.
The following provision in the scope
of review that I desire to call to the
-------
1274
LEGAL COMPILATION—PESTICIDES
attention of the Members is that in
cases "where the decision is in excess
of statutory jurisdiction, authority,
or limitations, or short of statutory
right," such decision can be set aside.
In other words, where the person who
has been tried has had taken away
from him the legal rights to which he
is entitled; or the limitation to which
he is entitled under the provisions of
the law have been reduced, then that
character of decision under the scope
provided in this bill can be set aside.
Fourth. "Without observance of pro-
cedure required by law." That is a
potent and powerful reason. Decisions
thus can be set aside where there is no
observance of the legal procedure on
the part of the hearing administrator
or agent. When that authority has been
taken into his hands and he has failed
to observe the legal requirements and
procedures, then such a decision, predi-
cated upon that theory, can be set
aside.
Fifth. "A decision which is unsup-
ported by substantial evidence" can be
set aside. I mentioned just a little while
ago that many cases in which decisions
have been rendered upon a mere scin-
tilla of evidence, and not on the weight
of the evidence, have been discovered.
In many instances the decisions have
been based upon evidence which is not
competent. But under the provisions of
this bill it is required that all such de-
cisions shall be based upon and predi-
cated upon substantial evidence. That
is the only fair basis upon which deci-
sions of this character should be made
by either a court or any agency assum-
ing the authority to hear and deter-
mine cases.
The sixth provision applies to deci-
sions unwarranted by the facts to the
extent that the facts are subject to a
trial de novo by the reviewing court. It
is my judgment that under the scope of
review set forth in the pending bill it
wll give every person the opportunity
and right to have a fair, just, and im-
partial trial in the judicial proceeding,
and a complete review of the case
which has been conducted against him.
I hope this bill is passed without any
objection. This worth-while legislation
has been too long delayed already, and
it is my hope that it will be passed in
the House, fully approved by the other
body, and promptly signed by the
President.
[p. 5657]
Mr. RUSSELL. Mr. Chairman, at
the outset I must agree that this bill
in its entirety will be a valuable asset
to the people of America if it is passed.
In the main, it seeks to give the courts
a little more function with regard to
administrative agencies' rulings, de-
crees, orders, and judgments. In that
respect I am in full accord with the
terms of the bill.
Being a member of the lawyers' pro-
fession, I have always looked upon the
functions of our courts and the juris-
prudence of our country in general
with jealousy and zealousness. I have
always been able to speak with pride
of the jurisprudence of the American
Government because of the funda-
mental principles underlying the rules
by which the courts, both trial and ap-
pellate, are guided. Perhaps some of
you do not know it, but as far as I
know, without a single exception each
general principle of the rules of evi-
dence that have been adopted by the
courts is based upon some Biblical quo-
tation. Every rule is taken from the
Bible, when you analyze it and run it
back to its source. This fact alone
should make the American people
proud of American jurisprudence.
There is one thing I am somewhat ap-
prehensive about in regard to this bill.
It is for that reason I take the floor for
these few minutes. If you will turn
with me to page 38 to subsection (c) of
section 10,1 want to read the first part
of that paragraph to you. It is as fol-
lows :
Every agency action made reviewable by
statute and every final agency action for which
there is no other adequate remedy in any court
shall be subject to judicial review.
-------
STATUTES AND LEGISLATIVE HISTORY
1275
That is fine. That is excellent. That
is what the American people have been
clamoring for for the last few years.
The Congress has been clamoring for
it too. The paragraph reads further:
Any preliminary, procedural, or intermediate
agency action or ruling not directly reviewable
shall be subject to review upon the review of the
final agency action.
Now, that is fine, But here is the
clause or phrase that I am afraid of:
Except as otherwise expressly required by
statute—
I am afraid of that provision. I am
not in a position, because I did not
know the bill was up for consideration,
and I happened into the Chamber and
heard this discussion, to answer direct-
ly the way in which I think this would
preserve the dictatorial powers of that
agency or that authorization by law.
The law, of course, is what the Con-
gress makes. There are some laws
which I am not able to point out to you
right now which make it possible for
an agency to pass upon a question pre-
sented to them on the basis of the
slightest evidence, whether it be rele-
vant or irrelevant, whether it be ma-
terial or immaterial, and whether it be
prejudicial or not prejudicial.
The CHAIRMAN. The time of the
gentleman from Texas has expired.
Mr. SUMNERS of Texas. Mr. Chair-
man, I yield three additional minutes
to the gentleman.
Mr. SPRINGER. Mr. Chairman, I
yield one additional minute to the gen-
tleman.
Mr. RUSSELL. When an agency has
such an authorization, which under the
authorization is the law, then this act
is exempting that agency from a judi-
cial review or a passing upon that evi-
dence, regardless of the kind of evi-
dence it may be.
Mr. WALTER. Mr. Chairman, will
the gentleman yield?
Mr. RUSSELL. I am glad to yield to
the gentleman.
Mr. WALTER. The gentleman is not
seriously contending that an agency
decision based upon a mere scintilla of
evidence would hold up?
Mr. RUSSELL. If the law has made
it such, it will hold up under this very
phrase that I have just read. That is
what I am afraid of.
Mr. WALTER. Well, the very meas-
ure now under consideration is de-
signed to prevent that sort of thing,
and will prevent it.
Mr. RUSSELL. But this is the thing
I am afraid of, that is, giving life to
that power which the measure is sup-
posed to take away.
There is another bill pending in this
House, a very controversial bill. Per-
haps you heard of it this week on Cal-
endar Wednesday, where a provision is
embodied in that bill which I do not be-
lieve 25 Members—10 Members—not 5
Members—if they understood the legal
effect of that provision, would vote for
the bill with that in it, because they
would be cutting off their own noses
and denying themselves a right which
they hold near and dear. That same
provision is embodied in that bill. If it
becomes law, the law making that scin-
tilla of evidence binding upon the
court, then this bill will not take care
of it. That is my only objection to this
bill. I do not want to tie the hands of
the courts, but throughout the years of
American history there has developed
the most beautiful, the most equita-
ble, the most American jurisprudence
known throughout the world, a system
of jurisprudence under which each
man can go into court where justice,
and justice alone, will prevail.
I ask you to look into this question
because I am fearful that by this pro-
vision you are giving life to that which
you think you are destroying.
[p. 5660]
-------
1276 LEGAL COMPILATION—PESTICIDES
1.16a(3)(c) May 27: Senate concurs in House amendments, p.
5790
[No Relevant Discussion on Pertinent Section]
1.16b JUDICIAL INTERIM RELIEF AND REVIEW OF
AGENCY AMENDMENTS
September 6,1966, P.L. 89-554, §§705, 706, 80 Stat. 393
§ 705. Relief pending review
When an agency finds that justice so requires, it may postpone
the effective date of action taken by it, pending judicial review. On
such conditions as may be required and to the extent necessary to
prevent irreparable injury, the reviewing court, including the court
to which a case may be taken on appeal from or on application for
certiorari or other writ to a reviewing court, may issue all neces-
sary and appropriate process to postpone the effective date of an
agency action or to preserve status or rights pending conclusion
of the review proceedings.
§ 706. Scope of review
To the extent necessary to decision and when presented, the
reviewing court shall decide all relevant questions of law, interpret
constitutional and statutory provisions, and determine the mean-
ing or applicability of the terms of an agency action. The reviewing
court shall—
(1) compel agency action unlawfully withheld or unreason-
ably delayed; and
(2) hold unlawful and set aside agency action, findings and
conclusions found to be—
(A) arbitrary, capricious, an abuse of discretion, or
otherwise not in accordance with law;
(B) contrary to constitutional right, power, privilege, or
immunity;
(C) in excess of statutory jurisdiction, authority, or
limitations, or short of statutory right;
(D) without observance of procedure required by law;
(E) unsupported by substantial evidence in a case sub-
ject to sections 556 and 557 of this title or otherwise
reviewed on the record of an agency hearing provided by
statute; or
(F) unwarranted by the facts to the extent that the facts
are subject to trial de novo by the reviewing court.
In making the foregoing determinations, the court shall review the
whole record or those parts of it cited by a party, and due account
shall be taken of the rule or prejudicial error. [p. 393]
-------
STATUTES AND LEGISLATIVE HISTORY 1277
1.16b(l) HOUSE COMMITTEE ON THE JUDICIARY
H.R. REP. No. 901, 89th Cong., 1st Sess. (1965)
TITLE 5, UNITED STATES CODE, "GOVERNMENT
ORGANIZATION AND EMPLOYEES"
AUGUST 31,1965.—Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
Mr. WILLIS, from the Committee on Judiciary,
submitted the following
REPORT
[To accompany H.R. 10104]
The Committee on the Judiciary, to whom was referred the bill
(H.R. 10104) to enact Title 5, United States Code, "Government
Organization and Employees," codifying the general and perma-
nent laws relating to the organization of the Government of the
United States and to its civilian officers and employees, having
considered the same, report favorably thereon without amend-
ment and recommend that the bill do pass.
PRELIMINARY STATEMENT
Purpose.—The purpose of this bill is to restate in comprehensive
form, without substantive change, the statutes in effect before
July 1,1965, that relate to Government employees, the organization
and powers of Federal agencies generally, and administrative pro-
cedure, and to enact title 5 of the United States Code. In the revised
title 5, simple language has been substituted for awkward and
obsolete terms, and superseded, executed, and obsolete statutes
have been eliminated. This bill is a part of the program of the
Committee on the Judiciary of the House of Representatives to
enact into law all fifty titles of the United States Code.
History.—The statutes that relate to Government personnel
begin with the first statute enacted by Congress, 1 Stat. 23. With
the growth of the United States and the accompanying growth in
the size of the Government's work force and the complexity of
their duties, the personnel statutes grew in number and in com-
plexity. Attempts were made periodically to consolidate personnel
statutes, but these attempts had only partial success and grew obso-
lete through the enactment of subsequent statutes. The Commission
on Organization of the Executive Branch of the Government
[p.l]
-------
1278 LEGAL COMPILATION—PESTICIDES
(Hoover Commission), in its report on personnel and civil service,
February 1955, recommended that the Civil Service Commission
prepare and that Congress enact a statute to codify the personnel
statutes of the United States (Recommendation 17, pp. 82-83).
The need for codification of the statutes relating to personnel has
also been recognized by the Committees on Post Office and Civil
Service of both Houses, the Bureau of the Budget, and the Civil
Service Commission.
In June of 1956, the Civil Service Commission directed its Gen-
eral Counsel, L. V. Meloy, to undertake the recodification of title 5.
The recodification effort resulted in two earlier bills. H.R. 8748,
86th Congress, 1st session, which was introduced on August 20,
1959, and H.R. 4158, 88th Congress, 1st session, which was intro-
duced on February 25, 1963. Both bills were circulated among the
departments and agencies of the Government and, after receipt,
consideration, and adoption of the constructive comments submit-
ted, and incorporation of subsequent legislation, the bill was
revised into its present form. Throughout the project, close liaison
was maintained between the office of general counsel of the Civil
Service Commission and Dr. Charles J. Zinn, law revision counsel
for the House Committee on the Judiciary.
Inclusion and exclusion of statutes.—Title 5 as revised does not
include all the personnel statutes of the United States. Statutes
that relate to the employees of only one agency, if not previously
in title 5, have not been brought into the title. Statutes relating to
civilian employees which apply to more than one agency are
included in title 5 regardless of where they may have appeared
previously. Some of these statutes also apply to members of the
uniformed service.
Statutes that are temporary in nature are omitted from title 5.
A citation to each of these statutes which was in effect before July
1,1965, is provided in table III. .- gi
SECTION 705
Derivation: United States Code Revised Statutes and Statutes at Large
5 U.S.C. 1009 (d) June 11,1946, ch. 324, § 10 (d), 60
Stat. 243.
Standard changes are made to conform with the definitions
applicable and the style of this title as outlined in the preface to
the report.
SECTION 706
Derivation: United States Code Revised Statutes and Statutes at Large
5 U.S.C. 1009 (e) June 11,1946, ch. 824, § 10 (e), 60
Stat. 243.
-------
STATUTES AND LEGISLATIVE HISTORY 1279
Standard changes are made to conform with the definitions
applicable and the style of this title as outlined in the preface to
the report. [p. 17]
1.16b (2) SENATE COMMITTEE ON THE JUDICIARY
S. REP. No. 1380, 89th Cong., 2d Sess. (1966)
TITLE 5. UNITED STATES CODE "GOVERNMENT
ORGANIZATION AND EMPLOYEES"
JULY 21,1966.—Ordered to be printed
Mr. ERVIN, from the Committee on Judiciary,
submitted the following
REPORT
[To accompany H.R. 10104]
The Committee on the Judiciary, to which was referred the bill
(H.R. 10104), to enact title 5, United States Code, "Government
Organization and Employees," codifying the general and permanent
laws relating to the organization of the Government of the United
States and to its civilian officers and employees, having considered
the same, reports favorably thereon, with amendments, and recom-
mends that the bill, H.R. 10104, as amended, do pass. [p. 1]
SECTION 705
Derivation: United States Code Revised Statutes and Statutes at Large
5 U.S.C. 1009 (d) June 11,1946, ch. 324, § 10 (d), 60
Stat. 243.
Standard changes are made to conform with the definitions
applicable and the style of this title as outlined in the preface of the
report. [p. 33]
SECTION 706
Derivation: United States Code Revised Statutes and Statutes at Large
5 U.S.C. 1009 (c) June 11,1946, ch. 324, § 10 (e), 60
Stat. 243.
Standard changes are made to conform with the definitions
applicable and the style of this title as outlined in the preface to the
report. [p. 34]
1.16b (3) CONGRESSIONAL RECORD
1.16b(3) (a) VOL. Ill (1965), Sept. 7: Passed House, p. 22954
[No Relevant Discussion on Pertinent Section]
1.16b(3) (b) VOL. 112 (1966), July 25: Amended and passed Sen-
ate, pp.17010,17011
[No Relevant Discussion on Pertinent Section]
-------
1280 LEGAL COMPILATION—PESTICIDES
1.16b(3)(c) VOL. 112 (1966), Aug. 11: House concurs in Senate
amendments, p. 19077
[No Relevant Discussion on Pertinent Section]
1.17 PER DIEM, TRAVEL AND TRANSPORTATION EX-
PENSES; EXPERTS AND CONSULTANTS; INDIVID-
UALS SERVING WITHOUT PAY, AS AMENDED
5 U.S.C. §5703 (1966)
[Referred to in 15 U.S.C. §1475(b)]
(See, "General 1.15a-1.15d (3) (c)" for legislative history)
PER DIEM, TRAVEL, AND TRANSPORTATION EXPENSES;
EXPERTS AND CONSULTANTS; INDIVIDUAL
SERVING WITHOUT PAY
5 § 5703.
(a) For the purpose of this section, "appropriation" includes
funds made available by statute under section 849 of title 31.
(b) An individual employed intermittently in the Government
service as an expert or consultant and paid on a daily when-actual-
ly-employed basis may be allowed travel expenses under this sub-
chapter while away from his home or regular place of business,
including a per diem allowance under this subchapter while at his
place of employment.
(c) An individual serving without pay or at $1 a year may be
allowed transportation expenses under this subchapter and a per-
diem allowance under this section while en route and at his place
of service or employment away from his home or regular place of
business. Unless a higher rate is named in an appropriation or
other statute, the per diem allowance may not exceed—
(1) the rate of $25 for travel inside the continental United
States; and
(2) the rates established under section 5702 (a) of this title
for travel outside the continental United States.
(d) Under regulations prescribed under section 5707 of this
title, the head of the agency concerned may prescribe conditions
under which an individual to whom this section applies may be
reimbursed for the actual and necessary expenses of the trip, not
to exceed an amount named in the travel authorization, when the
maximum per diem allowance would be much less than these ex-
penses due to the unusual circumstances of the travel assignment.
The amount named in the travel authorization may not exceed—
(1) $40 for each day in a travel status inside the continen-
tal United States; or
-------
STATUTES AND LEGISLATIVE HISTORY 1281
(2) the maximum per diem allowance plus $18 for each
day in a travel status outside the continental United States.
Pub.L. 89-554, Sept. 6, 1966, 80 Stat. 499; and amended Pub.L.
91-114, § 2, Nov. 10, 1969, 83 Stat. 190.
1.18 FEDERAL WATER POLLUTION CONTROT ACT, AS
AMENDED
33 U.S.C. §1254(e)(l)-(2)
Collection and dissemination of scientific knowledge on effects
and control of pesticides in water
(I) (1) The Administrator shall, after consultation with ap-
propriate local, State, and Federal agencies, public and private
organizations, and interested individuals, as soon as practicable
but not later than January 1, 1973, develop and issue to the States
for the purpose of carrying out this chapter the latest scientific
knowledge available in indicating the kind and extent of effects
on health and welfare which may be expected from the presence of
pesticides in the water in varying quantities. He shall revise and
add to such information whenever npr"*""-*™ to reflect developing
scientific knowledge.
(2) The President shall, in consultation with appropriate local,
State, and Federal agencies, public and private organizations, and
interested individuals, conduct studies and investigations of meth-
ods to control the release of pesticides into the environment which
study shall include examination of the persistency of pesticides in
the water environment and alternatives thereto. The President
shall submit reports, from time to time, on such investigations to
Congress together with his recommendations for any necessary
legislation.
June 30,1948, c. 758, Title I §104, as added Oct. 18, 1972, Pub.L.
92-500, 32, 86 Stat. 822.
1.18a THE WATER QUALITY IMPROVEMENT ACT OF 1970
April 3,1970, P.L. 91-224, §105(L), 84 Stat. 112
AN ACT
To amend the Federal Water Pollution Control Act, as amended, and for
other purposes.(
Be it enacted by the Senate and House of Representatives of the United
States of America in Congress assembled,
TITLE I—WATER QUALITY IMPROVEMENT
SEC. 101. This title may be cited as the "Water Quality Improve-
ment Act of 1970".
-------
1282 LEGAL COMPILATION—PESTICIDES
SEC. 105.
*******
"(1) (1) The Secretary shall, after consultation with appropri-
ate local, State, and Federal agencies, public and private organiza-
tions, and interested individuals, as soon as practicable but not later
than two years after the effective date of this subsection, develop
and issue to the States for the purpose of adopting standards pur-
suant to section 10 (c) the latest scientific knowledge available in
indicating the kind and extent of effects on health and welfare
which may be expected from the presence of pesticides in the water
in varying quantities. He shall revise and add to such information
whenever necessary to reflect dev^i'™1'"^ scientific knowledge.
[p. 112]
"(2) For the purpose of assuring effective implementation of
standards adopted pursuant to paragraph (1) the President shall,
in consultation with appropriate local, State, and Federal agencies,
public and private organizations, and interested individuals, con-
duct a study and investigation of methods to control the release of
pesticides into the environment which study shall include exam-
ination of the persistency of pesticides in the water environment
and alternates thereto. The President shall submit a report on such
investigation to Congress together with his recommendations for
any necessary legislation within two years after the effective date
of this subsection."
(3) in redesignated subsection (m) (4) by striking out the
words "and June 30,1969," and inserting in lieu thereof "June
30, 1969, June 30, 1970, and June 30, 1971,";
(4) by amending the first sentence of redesignated subsec-
tion (n) to read as follows: "There is authorized to be appro-
priated to carry out this section, other than subsection (g) (1)
and (2), not to exceed $65,000,000 per fiscal year for each of
the fiscal years ending June 30,1969, June 30, 1970, and June
30, 1971. There is authorized to be appropriated to carry out
subsection (g) (1) of this section $5,000,000 for the fiscal
year ending June 30, 1970, and $7,500,000 for the fiscal year
ending June 30, 1971. There is authorized to be appropriated
to carry out subsection (g) (2) of this section $2,500,000 per
fiscal year for each of the fiscal years ending June 30, 1970,
and June 30,1971.".
[p. 113]
-------
STATUTES AND LEGISLATIVE HISTORY 1283
1.18a (1) HOUSE COMMITTEE ON PUBLIC WORKS
H.R. REP. No. 91-127, 91st Cong., 1st Sess. (1969)
WATER QUALITY IMPROVEMENT ACT OF 1969
MARCH 25, 1969.—Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
Mr. FALLON, from the Committee on Public Works,
submitted the following
REPORT
[To accompany H.R. 4148]
The Committee on Public Works, to whom was referred the bill
(H.R. 4148) to amend the Federal Water Pollution Control Act,
as amended, and for other purposes, having considered the same,
report favorably thereon with an amendment and recommend that
the bill as amended do pass.
The amendment is as follows:
The amendment strikes out all after the enacting clause and
inserts a substitute text which appears in italic type in the
reported bill. r ^ -,
(1) (1) The Secretary shall, after consultation with appropriate
local, State, and Federal agencies, public and private organizations,
and interested individuals, as soon as practicable but not later than
two years after the effective date of this subsection, develop and
issue to the States for the purpose of adopting standards pursuant
to section 10 (c) the latest scientific knowledge available in indicat-
ing the kind and extent of effects on health and welfare which may
be expected from the presence of pesticides in the water in varying
quantities. He shall revise and add to such information whenever
necessary to reflect developing scientific knowledge.
(2) For the purpose of assuring effective implementation of
standards adopted pursuant to paragraph (1) the President shall,
in consultation with appropriate local, State, and Federal agencies,
public and private organizations, and interested individuals, con-
duct a study and investigation of methods to control the release
of pesticides into the environment which study shall include exam-
ination of the persistency of pesticides in the water environment
and alternatives thereto. The President shall submit a report on
such investigation to Congress together with his recommendations
for any necessary legislation within two years after the effective
date of this subsection. [p. 11]
-------
1284 LEGAL COMPILATION—PESTICIDES
1.18a (2) SENATE COMMITTEE ON PUBLIC WORKS
S. REP. No. 91-351,91st Cong., 1st Sess. (1969)
AMENDING THE FEDERAL WATER POLLUTION CON-
TROL ACT, AS AMENDED, AND FOR OTHER PURPOSES
AUGUST 7 (legislative day, AUGUST 5), 1969.— Ordered to be printed
Mr. MUSKIE, from the Committee on Public Works,
submitted the following
REPORT
[To accompany S. 7]
The Committee on Public Works, to which was referred the bill
(S. 7), having considered the same, reports favorably thereon with
amendments and recommends that the bill (as amended) do pass.
INTRODUCTION
S. 7, as reported, includes three titles, the first two of which
would amend the Federal Water Pollution Control Act, establish
an environmental policy for Federal public works projects and pro-
vide for the establishment of an Office of Environmental Quality.
Title I of this legislation would provide specific approaches for
dealing with particular kinds of water pollution problems and
directing that additional studies be made with regard to some of
their more complex aspects.
For the first time the President would have power and author-
ity to deal with disastrous oil spills which threaten serious injury
to the Nation's waters and beaches.
The bill also breaks new ground by requiring compliance with
water quality standards by all activities over which the Federal
Government has direct control or for which Federal licenses or per-
mits are required. Discharges of sewage from vessels which foul
many of the Nation's marinas, harbors, and ports will be subject
to control measures.
Authority would be provided to designate those hazardous sub-
stances, the discharge of which into the Nation's waters, presents
a substantial endangerment to health and welfare.
Authorization for continued research under the act are provided
as is new authority to solve specific pollution problems caused by
eutrophication (the natural process of aging of lakes) and the
acid mine drainage. , -,
-------
STATUTES AND LEGISLATIVE HISTORY 1285
Title II of this bill sets forth a fundamental procedure to coordi-
nate Federal, and federally assisted public works activities to
assure adequate consideration of the environmental policies set by
the Water Quality Act, the Air Quality Act, and the Solid Waste
Disposal Act. This title of S. 7, as reported, is designed to bring
coherent and integrated management of those environmental poli-
cies into the programs of the Federal Government.
Title III includes provisions for acquiring land for use of the
U. S. Senate.
The provisions, their ramifications and the intent of the com-
mittee will be discussed in detail by title.
[No Relevant Discussion on Pertinent Section]
1.18a (3) COMMITTEE OF CONFERENCE
H.R. REP. No. 91-940, 91st Cong., 2d Sess. (1970)
WATER QUALITY IMPROVEMENT ACT OF 1970
MARCH 24,1970.—Ordered to be printed
Mr. FALLON, from the committee of conference,
submitted the following
CONFERENCE REPORT
[To accompany H.R. 4148]
The committee of conference on the disagreeing votes of the two
Houses on the amendments of the Senate to the bill (H.R. 4148) to
amend the Federal Water Pollution Control Act, as amended, and
for other purposes, having met, after full and free conference,
have agreed to recommend and do recommend to their respective
Houses as follows:
That the House recede from its disagreement to the amendment
of the Senate to the text of the bill and agree to the same with an
amendment as follows:
In lieu of the matter proposed to be inserted by the Senate
amendment insert the following:
*******
[p.l]
Conference substitute
Section 105 of the conference substitute amends section 5 of the
Federal Water Pollution Control Act as follows:
(1) By relettering the last two subsections and inserting
after subsection (f) new subsections (g) through (1).
-------
1286
LEGAL COMPILATION—PESTICIDES
(2) The new subsection (g) provides the same authority
with respect to training of personnel as was provided by the
Senate amendment in its amendment to section 5 (g).
The new subsection (h) provides for the same authority with
respect to lake eutrophication as was contained in the Senate
amendment. It would authorize financial assistance for the con-
struction of publicly owned research facilities by public agencies,
including publicly owned universities.
The new subsection (i), relating to research on oil removal prob-
lems with the substitution of the requirement that the specifica-
tions be developed from time to time, rather than by June 30, 1970,
and with other minor changes is the same as the Senate amend-
ment in this regard.
The new subsection (j), relating to marine sanitation device
research is essentially the same as the provisions contained in the
proposed subsection (j) in the House bill.
The new subsection (k), relating to land acquisition, is essen-
tially the same as the comparable provisions in both the House
bill and Senate amendment.
The new subsection (1) is essentially the same as the proposed
subsection (j) in the Senate amendment relating to pesticides with
the exception that reference to criteria has been deleted, and the
term "scientific knowledge" substituted therefor, and the require-
ment of making the study on pesticides has been placed in the
President rather than the Secretary. The conferees expect that the
Secretary will consult with the Secretary of HEW on the health
aspects of pesticides and will avoid duplication of the research
activities of the Department of HEW
[p- 60]
1.18a (4) CONGRESSIONAL RECORD
1.18a (4) (a) VOL. 115 (1969), April 16: Amended and passed
House, p. 9293
[No Relevant Discussion on Pertinent Section]
1.18a (4) (b) VOL. 115 (1969), Oct. 7: Senate debated and amend-
ed, pp. 28923-28924, 28987-29008
THE PESTICIDE PERIL—LXII
Mr. NELSON. Mr. President, the
fine publications sponsored by our
country's conservation organizations
have been on the forefront of inform-
ing concerned citizens regarding the
threat to our wildlife and our total
environment from persistent pesti-
cides.
The August-September issue of
National Wildlife Magazine includes
an editorial which expertly outlines
the pesticide issue. Like so many
other accounts, the editorial reports
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STATUTES AND LEGISLATIVE HISTORY
1287
on the growing evidence of fish and
wildlife destruction from DDT and
related pesticides and on the buildup
of pesticide residues in man. In the
face of this rapidly accumulating data,
the editorial strongly states:
The widespread use of DDT should be
halted immediately unless its safety can be
proven.
I ask unanimous consent that the
editorial be printed in the RECORD.
There being no objection, the article
was ordered to be printed in the
RECORD, as follows:
OUB POINT OF VIEW, DDT THREATENS Youl
(By Ed Chaney, Director, Information Services)
Thousands of tons of DDT have been ladled
onto lands surrounding Lake Michigan over the
past 20 years to combat real, and sometimes
imaginary threats from a variety of creepy
crawlies.
This perennial application contains poison
that moves freely from place to place and retains
its toxicity for a guesstimated half century or
more. Yet it has become an accepted method
of dealing with pests. And over the years—
via wind, water and soil — DDT has washed
into Lake Michigan from farms, orchards,
mosquito swamps, elm-lined streets, flower
beds and even from mothproofing by dry clean-
ers.
Occasionally, someone would wonder at the
scarcity of robins after the community elms
were doused with DDT to fight Dutch elm dis-
ease. Once in a while a few unexplainably dead
fish would appear in a nearby creek. And
sometimes an article claiming DDT was eating
the livers out of eagles and ospreys would turn
up on the back page of our paper.
"SILENT SPUING" SILENCED
But compared to the commotion over the
surtax, the ABM and getting Johnny ready
for graduation, these isolated incidents seemed
of little concern to most people. Dr. George
Mehren. former Assistant Secretary of Agri-
culture, summed up the tenor of the times in
a statement to a congressional committee in
1968, "... the hysteria associated with 'Silent
Spring' has effectively subsided."
But then it happened 1 The Food and Drug
Administration put the grabs on more than
[p. 28923]
10 tons of Lake Michigan coho salmon en
route to family dinner tables. The salmon con-
tained up to 19 parts per million DDT—almost
three times the maximum allowed in beef sold
for human consumption. Suddenly, the funda-
mental relationship of DDT to man's position
at the top of the natural food chain became an
exciting topic of conversation for folks living
in the Great Lakes area.
The coho seizures added fuel to the smolder-
ing coals of Rachel Carson's best seller which
had already been furiously fanned by a group
of citizens and scientists banded together in
the "Environmental Defense Fund." Attempt-
ing to ban DDT as a water pollutant in the
state of Wisconsin, EDF paraded an impres-
sive array of scientists through the national
press damning DDT as a heinous, uncontrolla-
ble global pollutant.
Reaction to the contaminated coho im-
poundment was quick. Lacking an established
tolerance level for DDT in fish. Secretary Rob-
ert Finch of Health, Education and Welfare,
quickly set a temporary standard of five parts
per million. He also established a commission
to study the situation and present recommen-
dations within six months.
State and Federal fishery biologists pre-
dicted DDT levels in this year's crop of Lake
Michigan coho would reach that five parts per
million by mid-summer and several times that
concentration by fall. Because growing fish
concentrate DDT in their tissues, biologists
hold out little hope that millions of pounds of
valuable fish will be safe for consumption by
the end of the summer. The United States Bu-
reau of Commercial Fisheries also warned that
DDT levels in the lake are so high that repro-
duction of lake trout, salmon and other spe-
cies may be in real danger.
Visions of DDT scuttling the $200 million
Lake Michigan coho salmon fishing industry
brought prompt reaction from the governors
of the states surrounding Lake Michigan.
They met and declared there was no im-
mediate DDT health hazard in Lake Michigan.
Then they set up several committees to study
the problem to see if a tolerance level of 20
parts per million DDT would be safe for hu-
mans. (Nobody knows what a really safe limit
is. Whether it is 1, B, 20 or 100 parts per mil-
lion is an arbitrary judgment.)
Illinois Governor Richard B. Ogilvie an-
nounced his intention to continue drinking
Lake Michigan water and eating coho salmon.
The Michigan Department of Agriculture
"banned" DDT in April. This "ban" was anal-
ogous to slamming the barn door behind a
horse thief and giving him several years to get
out of town since it allows unlimited quanti-
ties of DDT to be sold and used in Michigan
if the chemical was in transit from the manu-
facturer by June 27. Consequently, new, home-
grown DDT will continue to pollute the air,
water, soil, wildlife and people of Michigan
for a long time.
It is a disturbing, spooky fact that no one
really knows what effects, if any, DDT has
on humans. Some eminent scientists maintain
it may be difficult, even impossible, to find out
until incalculable damage has occurred and it
is too late to do anything about it.
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1288
LEGAL COMPILATION—PESTICIDES
1 . PARTS PER PERSON
We do know the average American carries
around approximately 12 parts per million
DDT in his body. Man gets an estimated 90
percent of his DDT from food. We also know
it is passed on to the human fetus via the
mother's placenta and a nursing mother's
milk generally contains more DDT than is
allowed in milk you buy at the store.
Laboratory experiments with various ani-
mals have shown DDT attacks the central ner-
vous system, upsets body chemistry, distorts
cells, accelerates gene mutation, reduces drug
effectiveness and affects calcium absorption by
the bones.
Hungarian experiments with mice empha-
sized DDT's cancer-producing potential, and
that country recently banned its use. These
carcinogenic properties were confirmed by a
recent controversial six-year study by the
National Cancer Institute which found DDT
in mice did cause tumors, most of which
". . . had malignant potential."
A pharmacologist with a leading drug firm
says DDT has a deleterious effect on rats' sex
hormones, which are essentially the same as
man's. Further, the amount of DDT necessary
to produce that effect ". . . is well within the
range of DDT found in human fat."
All this growing, damning evidence does
not absolutely prove DDT is having or might
have the same effects on the human animal.
But Dr. Wayland Hayes, past chief of the
Public Health Service toxology section, has
said, "In considering the safety of workers
who formulate DDT, we must depend largely
on animal experiments."
Unfortunately, the evidence damning DDT
as a potential threat to mankind, all the lab-
oratory experiments, state and Federal study
groups, commissions and exploding public
concern, may have little impact.
IT'S BIO BUSINESS
The manufacture of DDT is a $20 million
a year business, and pesticide manufacturers
also fear the fight over DDT will carry over
onto its persistent chlorinated hydrocarbon
relatives, heptachlor, lindane, aldrin, endrin,
dieldrin, and chlordane which constitute a big
part of the industry's $1 billion annual sales.
The pesticide lobby is powerful, experienced
and at the slightly disparaging word aimed at
DDT, industry spokesmen trot out an im-
pressive array of truths extolling its virtues
in fighting disease organisms and agricultural
pests throughout the world. No one contests
these truths.
But there are substitutes for DDT "in the
form of safe non-persistent insecticides. In-
sect sterilization offers much hope for counter-
acting certain pests, and research has been
stepped up on insect predators.
But DDT's apologists continue their cam-
paign that DDT is indispensable to the wel-
fare of mankind and get away with it. They
know from past experience that the public's
memory is short and the people who make the
laws and buy the products don't read history
books. The decisions will be made behind the
scenes.
Agriculture committees in state and Fed-
eral government are almost universally dom-
inated by farm and pesticide-oriented legisla-
tors. These committees are commonly consid-
ered rubber stamps for all but the most offen-
sive industry pleas and graveyards for regu-
latory bills.
DDT's proponents seem willing to write off
the growing list of threatened wildlife includ-
ing the bald eagle, osprey, peregrine falcon,
eider duck, bermuda petrel, brown pelican and
even the sportsman-revered mallard duck.
During the EDF hearing in Madison, spokes-
men for the National Agricultural Manufac-
turers Association said, ". . . the damage is
not as severe as conservationists claim." One
of their arguments is that "DDT inhibits the
reproduction of birds . . . but these are pri-
marily birds of prey, and very small numbers
are involved." And, "A person whose thing is
studying the peregrine falcon is concerned only
about every little thing that might happen to
his bird."
CAN'T PROVE HUMAN EFFECTS
When the question of DDT's possible ef-
fects on humans is raised, their answers boil
down to "prove it." Despite the overwhelming,
growing scientific evidence that portends
frightening effects on man, DDT's fans are
willing to gamble. And they have graciously
volunteered the rest of the world.
The already dangerous and climbing levels of
DDT in the food fish of Lake Michigan may be
a grim hint of what is to come. Even if not
another ounce of DDT were applied anywhere
in the world beginning today, some experts
guess it would be at least 25 years before the
concentrations in the environment begin to
level off. However, researchers have revealed
a great deal of variability in the chemical's
persistence depending upon local conditions.
Our exploding technology now keeps some
men alive with artificial hearts and puts oth-
ers on the moon. What unknown secrets will
we discover about the 12 parts per million
DDT we all carry in our bodies? At this level,
the FDA would rule the average American
unfit for human consumption.
John Gottschalk, Director of the Bureau of
Sports Fisheries and Wildlife, said "What is
happening in Lake Michigan is an indication
of what to expect elsewhere. There will be a
day, and it may not be until the year 2000,
when we are the coho salmon."
The widespread use of DDT should be halted
immediately unless its safety can be proven.
[p. 28924]
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STATUTES AND LEGISLATIVE HISTORY
1289
WATER QUALITY IMPROVE-
MENT ACT OF 1969
The Senate resumed the considera-
tion of the bill (S. 7) to amend the
Federal Water Pollution Control Act,
as amended, and for other purposes.
Mr. CURTIS. Mr. President, I have
an amendment at the desk, and I ask
that it be read.
The PRESIDING OFFICER. The
amendment will be stated.
The assistant legislative clerk read
as follows:
On page 66, line 6, strike out the word
"two" and insert "three"; and in line 7,
strike out the word "two" and insert "three".
Mr. CURTIS. Mr. President, under
section 16 (c) (6) it is provided that
for any facility being constructed
under a Federal license on the date of
enactment of S. 7, no certification
under section 16(c) (1) is required
for any Federal operating license
necessary for such facilities, if such
operating license is issued within 2
years following the date of enactment.
The subsection further provides that
after 2 years, the licensee must pro-
vide certification or see its operating
license terminate.
This provision is directed princi-
pally at facilities licensed under the
Atomic Energy Act and is designed
to require those facilities to comply
with applicable water quality stan-
dards particularly as they relate to
thermal pollution. This objective is
laudible and I support it. However,
the 2-year period of time for facili-
ties being constructed to revise their
specifications is possibly too short. The
installation of facilities necessary to
achieve compliance with water quali-
ty standards involves millions of dol-
lars and requires considerable time for
design and construction. I, therefore,
submit, and the basis of my amend-
ment is, that the 2-year time period
in order that facilities under the pro-
visions of subsection 16(c) (6) be
given added time to achieve neces-
sary compliance.
I think this amendment is necessary
to avoid undue hardship while at the
same time achieving compliance with
water quality standards. The amend-
ment would merely extend the time 1
year.
I urge the adoption of the amend-
ment. It is my hope that the distin-
guished chairman of the committee,
who is in charge of the bill, will see
fit to accept it.
Mr. MUSKIE. Mr. President, I have
discussed this amendment with the
distinguished Senator from Nebraska
and the distinguished Senator from
Delaware (Mr. BOGGS). It does not in
any way change the thrust of this
provision of the bill or the principle
underlying it. It is a question of
allowing more time for plants that
began their construction before the
date of enactment of this bill to adjust
to its requirements. I have no objec-
tion to the amendment.
Mr. CURTIS. I thank the distin-
guished Senator very much.
I ask for a vote.
The PRESIDING OFFICER. The
question is on agreeing to the amend-
ment of the Senator from Nebraska.
The amendment was agreed to.
AMENDMENT NO. 132—ADDITIONAL
COSPONSORS
Mr. NELSON. Mr. President, I call
up my amendment No. 132, and I ask
unanimous consent that the names of
the following Senators be added as co-
sponsors of the amendment: Mr. Mus-
KIE, Mr. RANDOLPH, Mr. BAYH, Mr.
BROOKE, Mr. BURDICK, Mr. CANNON,
Mr. CASE, Mr. CHURCH, Mr. CRAN-
STON, Mr. DODD, Mr. EAGLETON, Mr.
GOODELL, Mr. GRAVEL, Mr. HARRIS, Mr.
HART, Mr. HARTKE, Mr. ROLLINGS, Mr.
INOUYE, Mr. JAVITS, Mr. KENNEDY,
Mr. MAGNUSON, Mr. MCGEE, Mr. Mc-
GOVERN, Mr. MclNTYRE, Mr. MONDALE,
Mr. Moss, Mr. PELL, Mr. PROXMIRE,
Mr. TYDINGS, Mr. WILLIAMS of New
Jersey, and Mr. YOUNG of Ohio.
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1290
LEGAL COMPILATION—PESTICIDES
The PRESIDING OFFICER. With-
out objection, it is so ordered.
The amendment will be stated.
The assistant legislative clerk read
as follows:
AMENDMENT NO. 132
On page 69, line 7, in lieu of "(k)" insert
"(1)".
On page 72, between lines 8 and 9, insert
the following: "(j) (1) The Secretary shall,
after consultation with appropriate local,
State, and Federal agencies, public and private
organizations, and interested individuals, as
soon as practicable but not later than two
years after the effective date of this subsec-
tion, develop and issue to the States for the
purpose of adopting standards pursuant to
section 10 (c) criteria reflecting the latest sci-
entific knowledge useful in indicating the kind
and extent of effects on health and welfare
which may be expected from the presence of
pesticides in the water in varying quantities.
He shall revise and add to such criteria when-
ever necessary to reflect developing scientific
knowledge.
"(2) For the purpose of assuring effective
implementation of standards adopted pursu-
ant to paragraph (1) the Secretary shall, in
consultation with appropriate local. State,
and Federal agencies, public and private or-
ganizations, and interested individuals, con-
duct a study and investigation of methods to
control the release of pesticides into the envi-
ronment, which study shall Include examina-
tion of the persistency of pesticides in the
water environment and alternatives thereto.
The Secretary shall submit a report on such
investigation to Congress together with his
recommendations for any necessary legislation
within two years after the effective date of
this subsection."
On page 72, line 9, in lien of "(j)" in-
sert ("k").
Mr. NELSON. Mr. President, in a
recent grim scenario, a noted ecolo-
gist, Dr. Paul Ehrlich, projects the
[p. 28987]
end of the oceans as a significant
source of life in 10 years. Mass starva-
tion of mankind follows, then war.
Dr. Ehrlich says if present trends
continue, such a disastrous end to life
on earth could be perilously near.
Not surprisingly, pesticides were a
key part of Dr. Ehrlich's setting for
disaster. As the first dramatic danger
signal of the threat to life in the sea,
the ecologist cites the report in 1968
that DDT slows down photosynthesis
in marine plant life.
In his article in Ramparts maga-
zine, Dr. Ehrlich spells out the impli-
cations :
It was announced in a short paper in the
technical journal, Science, but to ecologists
it smacked of doomsday. They knew that all
life In the sea depends on photosynthesis, the
chemical process by which green plants bind
the sun's energy and make it available to
living things. And they knew that DDT and
similar chlorinated hydrocarbons had pol-
luted the entire surface of the earth, including
the sea.
Events moved inexorably from that
point on in the Ehrlich scenario, with
pesticides continuing to play a major
role. Through the present, all events
he cites are fact. For the future, he
bases his conjecture on current trends.
Implausible to project the end of
the oceans and man in 10 years? There
have been too many "implausibles" or
"impossibles" in this century that have
come true: World War I, World War
II, the atomic bomb, the hydrogen
bomb, the war in Vietnam, the riots in
American cities and universities, the
assassination of a President, a candi-
date for President, and an interna-
tional civil rights leader. One can read-
ily understand the perceptive comment
of Nobel Prize Winning Biologist Dr.
George Wald that today's youth are
the first generation that believes, and
with good reason, that there may be
no future.
And as we move into the last third
of the 20th century, it has become
dramatically clear that the danger we
face from the destruction of the habi-
tat and life support systems of man
by overpopulation and pollution is as
great as that from nuclear holocaust.
Only a short time ago, anyone dis-
cussing our environmental problems
could not have thought to include pes-
ticides as a major threat. Like other
technological innovations that have
brought shocking byproducts, pesti-
cides have come into being and then
into mass use with stunning speed.
-------
STATUTES AND LEGISLATIVE HISTORY
1291
DDT DISCOVERED
For instance, DDT was first formu-
lated in 1874. But its properties as an
insecticide were not discovered and
put into use until World War II. Al-
most immediately, DDT became known
as the miracle insecticide that helped
control tropical disease and win the
war.
Since then, thousands of millions
of pounds of DDT and other synthetic
pesticides have been applied to millions
of acres to regulate economic plant or
animal populations to protect food and
fibre crops, reduce vectors of disease,
and abate pest nuisances.
Their fame spread as did their use.
Billions upon billions of pests have
fallen victim to their dust, spray, or
powder.
But new strains of pests developed
with increased resistance to DDT and
other common pesticides.
Too often, instead of seeking more
effective, more selective means of pest
control, the reaction of many users has
been to apply more, perhaps two,
three, 10 times as much, to overcome
the pest's newly attained resistance.
Today, nearly 900 million pounds of
pesticides, including insecticides, herbi-
cides, fungicides, rodenticides, and
fumigants, are sold annually in the
United States alone, more than 4
pounds for every American. Last year,
the sales of pesticides increased some
10 percent over the previous year, and
by 1985, it is estimated that they will
increase another sixfold.
Reports indicate that about 1 acre
of every 10 in America is treated with
an average of nearly 4 pounds of pes-
ticides every year.
And in little over 25 years, DDT
and other pesticides have been spread
by the soil, wind, the tide, and the
chain of life itself to the farthest
reaches of the earth. This and other
highly persistent, mobile pesticide com-
pounds are now one of the most easily
distinguishable marks of the presence
of man.
GLOBAL CONTAMINATION
Six years ago, two U.S. scientists
hypothesized that the entire globe may
already have been contaminated by
DDT. To find out, they went to Ant-
arctica. If any area of the world were
to be free of pesticide residues, it
would be that isolated continent, where
there are no pests, few animals or
plants, and where the nearest pesticide
use is thousands of miles away.
The scientists found pesticide resi-
dues in four of 16 Adelie penquin they
tested, four of 16 Wedell seals, and 15
of 16 skuas—a sea bird. The evidence
was inescapable. Worldwide pesticide
contamination was confirmed.
Another scientist, who measured
residues in the Antarctic snow melt,
estimated that over the last two and
a half decades, about 2,600 tons of
DDT could have accumulated in the
Antarctic snow and ice.
Scientists have yet to discover ex-
actly how DDT and other pesticides
have spread so far, so fast. But some
things are clear: DDT, with a half
life of 10 years, is remarkably hard to
break down, especially in the natural
environment where nature has not de-
veloped the means to decompose this
synthetic compound. And pesticides
such as DDT and Dieldrin are highly
mobile, able to travel through the
environment by any number of means.
The pesticide residues tend to con-
centrate to progressively higher levels
when they are picked up around the
globe by tiny organisms, then passed
up the food chain.
A well-researched example of this
characteristic was documented in Cali-
fornia. In order to control a trouble-
some flying insect that was hatching
in a lake in that State, the water was
treated with the insecticide DDD—
similar to DDT—yielding a concentra-
tion of 0.02 parts per million. Plank-
ton, which includes microscopic water-
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1292
LEGAL COMPILATION—PESTICIDES
borne plants and animals, accumulated
the DDD residues at five parts per
million. Fish eating the plankton con-
centrated the pesticide in their fat to
levels from several hundred to up to
2,000 parts per million. Grebes, diving
birds similar to loons, fed on the fish
and died. The highest concentration
of DDD found in the tissues of the
grebes was 1,600 parts per million.
If it were simply a case of another
compound sprawling over the earth
like dirt or air there might be little
cause for concern. But the implica-
tions of the pervasive pesticide ac-
cumulation are far more serious.
ACTIVE AGAINST LIFE
Dr. Charles Wurster, an organic
chemist and nationally known pesti-
cide expert assisting the Environmen-
tal Defense Fund, likens the pesticide
spread to mass use of biocides, agents
which are known by scientists as "ac-
tive against life."
"In general, if an organism has
nerves, DDT or Dieldrin can kill it,"
Wurster believes. He says the action
of other hard, chlorinated hydrocar-
bon pesticides such as Aldrin, Endrin,
Heptachlor and Toxaphene is similar.
Thus, Wurster says these compounds
"are toxic to almost the entire animal
world."
During a recent conference on pesti-
cides in Stockholm, evidence was pre-
sented that DDT, even in very small
quantities, could affect human metabo-
lism. One of the studies cited was Hus-
sion research that indicated that
workers whose jobs bring them in con-
tact with DDT and other organochlor-
ine pesticides were found to suffer
from changes in the liver which slowed
down the elimination of wastes from
the body.
A major study published this sum-
mer by the National Cancer Institute
found that at least 11 pesticides out
of 123 chemical compounds tested in-
duced a significantly increased inci-
dence of tumors in laboratory animals.
The 11 tumorigenic compounds in-
cluded five insecticides p.p' —DDT,
Mirex, bis(2-chlorethyl)-ether, chloro-
benzilate and strobane; five fungicides
PCNB, Avadex, Ethyl selenac, ethyl-
ene thiourea, and bis (2-hydroxyethyl)
dithiocarbamic acid potassium salt;
and one herbicide N-(hydroexthyl)
hydrazine.
While the researchers have reserved
judgment on whether these pesticides
should be considered as a potential
cause of cancer, it appears very cer-
tain that growing concern about the
threat of pesticides to human health is
entirely warranted.
In 25 years, then, we have turned
loose on the earth a massive dose of
compounds that can cripple or kill, and
which are tragically indiscriminate in
their attacks. When DDT is applied to
do one job, it lingers and accumulates
in the environment as a toxic threat
to fish, wildlife, and possibly even to
man.
Already, the petrel of Bermuda, the
bald eagle and peregrine falcon of
America and the blue shell crab of the
sea are each being pushed to the
brink of extinction by the spread of
pesticides through our environment.
Like so many other environmental
disasters, it is shocking that this has
happened. But what is almost beyond
belief is that, even from the begin-
ning, the pesticide dangers were
known.
The fact that DDT would kill wild-
life was determined in 1945, the same
[p. 28988]
year that the pesticide was released
for civilian use. The discovery was
made by wildlife biologists working in
U. S. Department of Agriculture
studies.
From that point on, scientific con-
cern continued to mount worldwide,
but, unfortunately, the debate sim-
mered out of the public eye for almost
two decades.
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STATUTES AND LEGISLATIVE HISTORY
1293
"SILENT SPRING"
Then, in 1962, came a dramatic
turning point: The New Yorker maga-
zine serialized a book by a lady biolo-
gist in the U.S. Department of Interior
that brought home to the public for
the first time the rapidly building
dangers from pesticide misuse. The
book was "Silent Spring," by Miss
Rachel Carson.
Challenging the myth that pesticides
were the panacea that they were being
proclaimed, Miss Carson said:
As crude a weapon as the cave man's club
has been hurled against the fabric of life.
Translated into 30 languages, the
book was read by millions in the
United States and around the world.
Almost single-handedly, it bridged the
gap between the scientist and the con-
cerned citizen which so often exists
in our complex society today.
In 1963, Miss Carson testified before
the Senate Government Operations
Committee, chaired by our colleague,
Senator ABRAHAM RIBICOFF.
Also in 1963, a report by the Presi-
dent's Science Advisory Committee,
chaired by Jerome Wiesner, concluded
that the goal of our national efforts
should be "elimination of the use of
persistent toxic insecticides."
In the following Congress, I initially
introduced legislation to ban the inter-
state sale and shipment of DDT. I
subsequently introduced the same leg-
islation in the 90th and 91st Congres-
ses, and similar measures have since
been introduced in the House. During
the past three Congresses, no commit-
tee hearings have 'been held on these
proposals.
However, interest around the coun-
try in achieving effective pesticide
controls continued to build, and there
was growing citizen impatience with
the failure of State and Federal agen-
cies to act.
Yet, despite the urgent warnings
and concern, our government agencies
have failed miserably to respond res-
ponsibly to this massive problem. Not
a single Federal office has taken any
significant action that would lead to
the goal of "eliminating" the use of
persistent toxic pesticides that was
established 6 years ago by the Presi-
dential committee.
AGENCIES INEFFECTIVE
The fact is that the Federal Govern-
ment has been perpetuating this grave
environmental and health problem,
rather than resolving it.
It was recently revealed that the
U.S. Department of Agriculture,
which is charged with regulating pes-
ticide use, has been sponsoring a pro-
gram with the Air Force and other
Government agencies under which
250,000 pounds of dieldrin has been
applied to 56 military and civilian
airports across the country over the
past 15 years.
This program, which has raised
strenuous objection from scientists,
was twice reviewed and approved by
the interdepartmental Federal Com-
mittee on Pest Control.
The committee, which is billed as
the regulator of Federal pesticide use,
recently confirmed that the General
Services Administration and the Of-
fice of the Capitol Architect have not
even submitted their pesticide pro-
grams to the committee for review.
Clearly, the Federal effort at regu-
lating itself has been as ineffective as
has the regulation of pesticide use at
large.
Ironically, a number of States, as
well as several foreign countries, have
shown far greater willingness to act
than the U.S. Government. DDT has
been banned by the States of Michigan
and Arizona, and overseas, by Den-
mark and Sweden. And countless cit-
ies and towns have stopped using DDT
in their mosquito control and tree
disease eradication programs. In addi-
tion, a number of States, including
Wisconsin, and California, are consid-
ering steps to drastically restrict the
-------
1294
LEGAL COMPILATION—PESTICIDES
use of DDT and other hard pesticides
within their borders.
These recent State and local mea-
sures are a reflection of the citizen
demand for action that has been build-
ing at a heartening pace.
For instance, the idea of creating
an Environmental Defense Fund grew
out of a suit filed in April 1966,
against the Suffolk County Mosquito
Control Commission, by Victor J.
Yannacone, Jr., a young lawyer, on
behalf of his wife, Carol, and all other
people of Suffolk County, Long Island.
The court challange was based on a
report that a DDT dumping by com-
mission employees was the cause of
a fish kill in a nearby lake.
The New York suit was successful
in leading to a temporary ban on the
use of DDT in Suffolk County by pub-
lic agencies, and gained public recog-
nition as one of the first attempts to
argue that the citizen has the right
under law to protect his environment.
Then in November of 1967, the
Environmental Defense Fund brought
its first court action in its own name,
seeking to prevent the use of dieldrin
in a Japanese-beetle control project
in Michigan by the Michigan and U.S.
Departments of Agriculture. Several
Michigan Conservation Department
affidavits, including one holding that
the spraying would threaten Lake
Michigan's new coho salmon fishery,
were disallowed on a technicality
when the State attorney general's
office refused to let the department
officially enter the case. The tragic
results of pesticide misuse for the
coho were to become evident 3 years
later.
In the Michigan suit, Yannacone
got a temporary order from the State
court of appeals to stop the dieldrin
spraying, but this injunction was dis-
solved after a 6-hour trial.
WISCONSIN DDT HEARINGS
One year later, the battleground
shifted to the other side of Lake
Michigan, to Madison, Wis., where
citizen groups and the Environmental
Defense Fund joined forces in a peti-
tion asking the State Department of
Natural Resources to ban the use of
DDT in the State under any circum-
stances where the pesticide can enter
the world circulation patterns and
further contaminate the biosphere.
With EDF, the petitions groups were
the Citizens Natural Resources Asso-
ciation of Wisconsin and the Wiscon-
sin division of the Izaak Walton
League.
In the State hearing which began
last December, the Alliance of Con-
cerned Scientists and Lawyers pre-
sented extensive testimony outlining
the growing pollution of the environ-
ment by persistent pesticides in the
chlorinated hydrocarbon family.
Dr. Robert W. Risebrough, an envi-
ronmental scientist at the University
of California at Berkeley, stated that
the effect of pesticides on man may be
very serious. He said that man accu-
mulates 12 parts per million of DDT
in his fatty tissues before the body
discharges it. He said that this is
enough to stimulate enzyme produc-
tion, which acts as a catalyst for
bodily processes, such as digestion.
Risebrough added that the death of
some birds has been traced to enzyme
induction by DDT, impairing their
ability to reproduce.
Dr. Charles F. Wurster, Jr., an
organic chemist at the State Univer-
sity of New York, Stonybrook, testi-
fied on the range of the pesticide resi-
dues through the world.
Other witnesses have testified that
DDT goes into the atmosphere along
with evaporating water, builds up to
extremely high levels in predator
birds and animals, and has caused new
insect problems by killing predators
that once held those insects in check.
Dr. Joseph Hickey, a University of
Wisconsin wildlife ecologist, said that
DDT has been linked to reproduction
-------
STATUTES AND LEGISLATIVE HISTORY
1295
failures of certain birds, including
the eagle, the osprey, and the pere-
grine falcon. Dr. Hickey and other
researchers have traced the presence
of pesticide residues to a decrease in
weight and thickness of the shells of
eggs produced by these birds.
In related testimony, Lucille Stickel,
the pesticide research coordinator of
the Interior Department's Patuxent
Wildlife Research Center, stated that
the presence of small quantities of
DDT and its derivative DDE in the
diets of mallard ducks decreased egg-
shell thickness, increased egg break-
age, and decreased overall reproduc-
tive success.
Although the second half of the
hearings, held last spring, was billed
as the time for the defense against
the arguments of the environmenta-
lists, the pesticide industry, which
historically has promoted more pesti-
cide use and fought new controls, made
a weak defense.
Industry witnesses who were knowl-
edgeable about the environmental
impact of pesticides were few and far
between. Instead, defense witnesses
relied on shopworn repetitions of the
past triumphs of DDT and trotted out
research from a decade ago which
purported to show that the health of
pesticide workers was not impaired
by constant exposure to the com-
pounds.
In fact, witnesses for the defense
often provided the environmentalists
with valuable evidence to support their
contentions. For example, a Shell
Development Co. scientist confirmed
the fact that DDT does not remain in
the soil, but has a great deal of mobil-
ity and persistence which enables it to
infiltrate the atmosphere, the waters,
[p. 28989]
and the total environment.
Another witness for the DDT
defense, a U.S. Department of Agri-
culture pesticide official, admitted that
his agency relies almost totally on
industry claims regarding health and
environmental effects.
An initial decision on the environ-
mentalists' petition is expected before
the end of this year.
COHO SALMON SEIZED
Midway through the Wisconsin
hearings, a new and dramatic confir-
mation of pesticide dangers was
announced to Wisconsin and the
Nation: The U.S. Food and Drug
Administration was seizing 28,150
pounds of frozen Lake Michigan Coho
salmon because it said high DDT and
dieldrin residues had made the fish
unfit for human consumption.
According to the FDA, the concen-
tration of DDT in the salmon was
found to be up to 19 parts per million,
while the accumulation of dieldrin was
just short of 0.3 of a part per million,
both levels considered hazardous by
the FDA and the World Health
Organization.
The contamination of the Coho
challenges a basic foundation of the
pesticide argument that has been
sounded for a quarter of a century—
that pesticide use is invariably an
economic benefit, that is to say, an
"economic" poison.
One might ask the commercial fish-
erman who sees the Coho salmon as a
great new opportunity in a lamprey-
ravaged Great Lakes fishery whether
the current pesticide approach is
"economic". One might also ask the
same question of the resort owner in
northern Michigan who saw his busi-
ness skyrocket with the introduction
of the salmon in Lake Michigan in
1965.
One might ask the economic benefit
question of the Michigan Department
of Natural Resources, which during
the 1966 EDF suit attempted to warn
of the danger to the Coho, and which
has invested millions of dollars to
plant Coho salmon fry in Lake Michi-
gan only to see nearly a million of the
fry killed by the pesticide contamina-
-------
1296
LEGAL COMPILATION—PESTICIDES
tion. And, finally, one might ask the
economic effects if the national recrea-
tion resource of the Great Lakes,
enhanced by millions of State and
Federal tax dollars, is further damaged
by the pesticide peril to the salmon
and other lake resources, including
the very quality of the water itself.
Ironically, the Lake Michigan Water
Pollution Conference in 1968 was
warned that the pesticide concentra-
tion in Lake Michigan was at the cri-
sis point. W. F. Carbine, Great Lakes
Regional Director for the Bureau of
Commercial Fisheries, stated:
Lake Michigan has the highest concentra-
tion of pesticides of any of the Great Lakes,
which now are only slightly below levels that
are known to be injurious to man or aquatic
life. ... A continuation at high levels or an
upsurge in pesticide application in the Lake
Michigan Basin could increase the pesticide
concentration prevailing in the open lake from
the present non-lethal level to a lethal value.
The evidence is already clear that
for the United States, the Lake Michi-
gan tragedy is only the beginning.
On June 17 of this year, 52 cases of
jack mackerel, caught on the west
coast, were confiscated in New York
by the Food and Drug Administra-
tion because of high DDT levels. The
mackerel appeared to be the first
ocean fish from American waters to
be declared unfit for human food
because of DDT.
In several central and northern
New York lakes, lake trout have either
been eliminated, or their reproduction
seriously impaired, because of high
pesticide levels. DDT concentrations
in the lake trout of up to 3,000 parts
per million in the fatty tissues have
already been reported.
NATIONAL PESTICIDE SURVEY
A 2-year national pesticide study
recently completed by the U.S. Bureau
of Sport Fisheries and Wildlife found
DDT in 584 of 590 samples of fish
taken from 45 rivers and lakes across
the United States.
The study results showed DDT
ranging up to 45 parts per million in
the whole fish, a count more than nine
times higher than the current FDA
guideline level for DDT residues in
fish.
Residues of DDT reached levels
higher than the FDA's temporary
limit of five parts per million in 12
of the rivers and lakes, including the
Hudson in New York; the Delaware;
the Cooper in South Carolina; St.
Lucie Canal and the Apalachicola in
Florida; the Tombigbee in Alabama;
the Rio Grande in Texas; Lake Onta-
rio; Lake Michigan; the Arkansas
and the White in Arkansas; and the
Sacramento in California.
Residues of dieldrin, a pesticide
even more toxic to humans than DDT,
were found in excess of the 0.3 parts
per million FDA limit in 15 rivers
and lakes including the Connecticut;
the Hudson; the Delaware; the Savan-
nah in Georgia; the Apalachicola; the
Tombigbee; the Rio Grande; Lake
Ontario; Lake Huron; the Illinois in
Illinois; the Arkansas and the White;
the Red River in Minnesota; the San
Joaquin in California; and the Rogue
in Oregon.
In summary, the comprehensive sur-
vey found DDT in almost 100 percent
of the fish samples, dieldrin in 75 per-
cent, heptachlor and/or heptaehlor
epoxide in 32 percent, and chlordane
in 22 percent.
Related research over the 4-year
period, ending in 1968, has determined
that more than 1,640,000 fish were
killed by pesticide pollution in the
Nation's waters, the result of pesti-
cide spills or runoff and concentration
in our waters. Millions of more fish
no doubt went unborn due to reproduc-
tive failures caused by pesticides.
Laboratory research has proven
that pesticide levels in water, of even
the low parts per billion, can 'be toxic
to adult fish. Levels in low parts per
trillion have been found to affect
reproduction.
Already, the pesticide levels in Lake
-------
STATUTES AND LEGISLATIVE HISTORY
1297
Michigan, the most pesticide-polluted
of the Great Lakes, are in the low
parts per trillion range.
And findings released just this
month by the U.S. Public Health Serv-
ice reported the detection of pesticides
in 76 of 79 samples of drinking water
supplies around the country. Although
the PHS report noted that so far the
pesticide levels have not exceeded
recommended permissible limits, the
health service was concerned. The
PHS said:
The high frequency of occurrence and our
lack of knowledge of the long-term health
effects of this class of compounds dictate the
need for increased surveillance and research
as well as for increased recognition of the
potential of this problem by state and local
health departments.
In summary, the already massive
and still accumulating evidence on pes-
ticides makes it clear that these toxic
compounds have become one of the
most serious problems of our envi-
ronment, and are threatening even
greater worldwide damage. Pesticides
have concentrated to the far ends of
the earth; they are killing fish and
wildlife; they have inhibited fish and
wildlife reproduction; high pesticide
residues have pushed some fish-feeding
birds and other animals to the edge
of extinction, and now, there is
increasing concern and evidence about
the threats posed to man.
The problem of pesticides in the
environment is showing up most dra-
matically and seriously in our rivers
and lakes. Although the bulk of pesti-
cide application is on land, the com-
pounds, especially hard pesticides like
DDT and dieldrin, are persisting long
enough to be carried by agricultural
and urban runoff into water bodies.
There, as I have pointed out, they
enter and are concentrated through
the food chain of marine life and fish-
feeding birds.
There is little question that pesti-
cides are a grave pollution threat, one
which we have barely acknowledged,
let alone dealt with. And if we con-
tinue to delay action to protect the
environment and man from these
compounds, I am gravely concerned
for the probable consequences.
Fortunately, there is an excellent
vehicle already available to us to deal
with the pollution aspects of the pes-
ticide problem—the Federal Water
Pollution Control Act, and particu-
larly the provisions added by the
Water Quality Act of 1965.
PESTICIDE AMENDMENT
It is to this act which my amend-
ment to Senate bill 7 is directed. Most
simply stated, the amendment provides
congressional direction to the Secre-
tary of the Interior to take certain
steps to deal with water pollution
problems of pesticides under the
authorities granted him by the pollu-
tion control statute.
I ask unanimous consent that an
analysis of the amendment be printed
in the RECORD at this point.
There being no objection, the ana-
lysis was ordered to be printed in the
RECORD, as follows:
ANALYSIS OP NELSON PESTICIDE POLLUTION
AMENDMENT
Under this two-part amendment, the Secre-
tary of the Interior would utilize the authori-
ties granted him by the Federal Water Pollu-
tion Control Act to deal with water pollution
caused by pesticides.
Part One directs the Secretary to develop
and issue to the states within two years water
quality criteria for all pesticides. The criteria
would list safe pesticide levels in water for
public water supplies, propagation of fish and
wildlife, recreational purposes, and other legiti-
mate uses.
The criteria would be issued for the pur-
pose of setting pesticide standards as part of
the interstate water quality standards already
adopted by the 50 states for other pollutants
under Federal and state laws.
For the purpose of setting the standards
[p. 28990]
Section IOC of the Federal Water Pollution
Control Act provides that ". . . if the Secre-
tary or the Governor of any State affected by
water quality standards . . . desires a revi-
sion in such standards, the Secretary may . . .
prepare regulations setting forth standards of
water quality to be applicable to interstate
waters...."
-------
1298
LEGAL COMPILATION—PESTICIDES
Under this procedure, the Secretary would
ask the states to revise their interstate water
quality standards to include pesticide limits.
If a state does not act, the Secretary is author-
ized to set the standards. Also, a state may, on
its own, request a revision of its standards.
In addition to serving as a basis for these
interstate water quality standards, the pesti-
cide criteria would also give the Secretary a
useful tool in ongoing and any future federal-
state pollution abatement conferences where
pesticide pollution might be occurring.
As is the case with present water quality
standards, responsibility for enforcing the
pesticide standards would rest primarily with
the states under an implementation plan
adopted by each state as part of the standards.
In the setting and implementing of the
standards, Federal law provides that consid-
eration must be given to their practicability
and physical and economical feasibility.
Means of implementing the standards could
include: state administrative or legislative ac-
tion to restrict the use of a pesticide pollutant
statewide or in the affected watershed; inter-
state action; integrated pest control; use of less
persistent pesticides; development of agents to
decompose pesticides; and biodegradability and
toxicity standards on the pesticides themselves.
Fart Two of the amendment directs the
Secretary of the Interior, in consultation with
appropriate Federal agencies and other con-
cerned parties, to conduct a study on methods
of controlling the release of pesticides into
our nation's lakes and rivers and the environ-
ment. The study will include examination of
the persistence of pesticides in the water and
alternatives thereto. Within two years, the
Secretary will submit a report on this study
to Congress, together with his recommendations
for any necessary legislation.
This study will assist the Secretary in per-
fecting existing means of dealing with pesti-
cide pollution and in determining new ones.
Mr. NELSON. Mr. President, Part
1 of the amendment requires the Sec-
retary to develop within 2 years water
quality criteria for all pesticides. The
criteria would set forth the effects of
various pesticide levels in water on
fish and wildlife, man and the envi-
ronment. Because they would outline
maximum safe levels, they would rep-
resent the essential basis for action
to deal with the pesticide pollution
problem.
Under his existing authorities, the
Secretary has already developed cri-
teria for a wide range of pollutants,
from municipal sewage to industrial
waste, and these are serving as the
basis for the interstate water quality
standards which have been set by all
50 States as the key to the national
pollution cleanup effort. Criteria have
been developed for some pesticides,
but they are general and incomplete,
and technical personnel have advised
that 2 years is a reasonable time to
allow development of comprehensive
pesticide criteria.
STATE STANDARDS INADEQUATE
After a review of the water quality
standards already adopted by the
States under the Federal act, it is very
clear that pesticides are dealt with
only in the most general way in the
standards, and it is doubtful that this
approach will lead to effective control.
For instance, only three States—
Alaska, California, and South Dakota
—have set specific numerical limits
for pesticides in their water quality
standards. Two other States—Idaho
and Virginia—specifically mention
pesticides in toxicity sections of their
standards. Otherwise, the State stand-
ards deal with pesticides only as they
would be covered in general narrative
statements on toxicity or by public
water supply or aquatic life criteria.
I requested the Federal Water Pol-
lution Control Administration to do
a State-by-State summary of pesti-
cide provisions in the water quality
standards, and I ask unanimous con-
sent that it be printed in the RECORD
at the end of this statement.
The PRESIDING OFFICER (Mr.
CRANSTON in the chair). Without
objection, it is so ordered.
(See exhibit 1.)
Mr. NELSON. Mr. President, based
on the preliminary criteria already
developed by the Interior Department,
the comprehensive pesticide guidelines
required by this amendment would no
doubt indicate what level of a specific
pesticide in water is hazardous to a
specific species of fish. In addition,
safe levels for pesticides would no
-------
STATUTES AND LEGISLATIVE HISTORY
1299
doubt be determined for other water
uses, including those of drinking,
swimming, and boating.
The comprehensive pesticide criteria
would be issued by the Secretary to the
States for the purpose of setting pes-
ticide standards as part of the inter-
state water quality standards already
adopted by the States under Federal
and State laws.
For the purpose of setting the
standards, section 10 (c) of the Fed-
eral Water Pollution Control Act
provides:
If the Secretary or the Governor of any State
affected by water quality standards . . . desires
a revision of such standards, the Secretary may
. . . prepare regulations setting forth standards
of water quality to be applicable to interstate
waters. . . .
Under this procedure, the Secre-
tary would ask the States to revise
their interstate water quality stand-
ards to include pesticide limits. If a
State does not act, the Secretary is
authorized to set the standards. Also,
a State may on its own request a
revision of its standards. The Federal
law provides that consideration must
be given in the standard setting to
practicability and physical and econo-
mic feasibility.
In addition to serving as a basis
for interstate water quality standards,
the pesticide criteria would also give
the Secretary a useful tool in ongoing
and any future Federal-State pollu-
tion abatement conferences where pes-
ticide pollution might be occuring.
The step-by-step procedure that
would be followed under the Federal
Water Pollution Control Act for
standard setting and implementation
follows:
First. The Secretary, after consul-
tation with interested, concerned par-
ties, would prepare and publish regu-
lations setting forth water quality
standards for pesticides, based on the
criteria he had developed.
Second. The States would then adopt
pesticide standards for their inter-
state waters, subject to the review and
approval by the Secretary as meeting
his comprehensive criteria. The States
could adopt more stringent standards
than provided by the criteria. If the
States did not adopt pesticide stand-
ards and did not petition the Secre-
tary for a public hearing on the ques-
tion, the Secretary is authorized to
promulgate the standards.
Third. Responsibility for enforcing
the standards would rest primarily
with the States, under an enforcement
plan adopted as part of the standards.
Implementation of the present water
quality standards for other pollutants
generally means the issuance by the
States of orders to polluters to take
remedial steps. If the orders are not
followed, State court action could fol-
low. Issuance of pollution cleanup
orders must be preceded by further
public hearings.
It is unlikely that action to imple-
ment pesticide standards under the
water pollution control law would be
by court action against pesticide users.
This is true principally because,
unlike municipal sewage which is dis-
charged from one point, pesticides
usually enter the water in a general-
ized fashion from a wide range of
sources. For instance, DDT may be
coming to a river from 100 farms, or
15 towns, in one watershed.
IMPLEMENTATION OF STANDARDS
Fortunately, there are more equita-
ble and efficient means available to
implement and enforce pesticide stand-
ards, approaches which would be car-
ried out by cooperative efforts between
users, pollution control and other pes-
ticide regulatory agencies, and pesti-
cide manufacturers:
First, State administrative or legis-
lative action to restrict or prohibit the
use of a pesticide pollutant statewide
or in the affected watershed. As
pointed out earlier, a number of
States, and cities and towns are
already taking this approach.
-------
1300
LEGAL COMPILATION—PESTICIDES
Second, interstate action, through
comparts, or the Federal-State pollu-
tion control conference provided in
Federal law, to restrict or prohibit
the use of certain pesticides. For
instance, a committee to the Federal-
State conference on Lake Michigan
made specific recommendations for
pesticide limits and other interstate
or uniform State actions.
Third, increased use of less persis-
tent pesticides as substitutes for com-
pounds such as dieldrin and DDT
which remain in a toxic state for
years. This would be coupled with
more efficient means of pesticide appli-
cation. The feasibility of this approach
is demonstrated by the fact that for
virtually all crops, the U.S. Depart-
ment of Agriculture lists more than
one pesticide as being able to control
harmful pests; I ask unanimous con-
sent that a list of readily degradable
pesticides prepared by the U.S.
Department of Agriculture be printed
in the RECORD at this point.
There being no objection, the list
was ordered to be printed in the
RECORD, as follows:
[p.28991]
-------
STATUTES AND LEGISLATIVE HISTORY
1301
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-------
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LEGAL COMPILATION—PESTICIDES
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LEGAL COMPILATION—PESTICIDES
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STATUTES AND LEGISLATIVE HISTORY
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1306
LEGAL COMPILATION—PESTICIDES
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-------
STATUTES AND LEGISLATIVE HISTORY
1307
Mr. NELSON. Mr. President,
fourth, is the increased use of systems
of integrated pest control, combining
biological and chemical controls, and
additionally, developing pest-resistant
crop strains. This approach is showing
increased success as an effective eco-
nomic means of pest control;
Fifth, further development of agents
which cause the persistent pesticides
to decompose more rapidly in the soil
and water after they have been
applied to a crop and accomplished
their task; and,
Sixth, the development of standards
on the biodegradability and toxicity of
pesticide components.
COMPREHENSIVE STUDY
Part 2 of the amendment directs the
Secretary of the Interior, in consulta-
tion with appropriate Federal agen-
cies, and other concerned parties, to
conduct a study on methods of control-
ling the release of pesticides in our
Nation's lakes and rivers and the envi-
ronment. The study will include exami-
nation of the persistency of pesticides
in the water and alternatives thereto.
Within the 2 years, the Secretary will
submit a report on this study to Con-
gress together with his recommenda-
tions for any necessary legislation.
This study should assist the Secre-
tary in perfecting existing means of
dealing with pesticide pollution and in
determining new ones, to assure equit-
able and enforceable standards.
There is abundant evidence to show
that the six approaches—State action,
interstate action, integrated pest con-
trol, use of less persistent pesticides,
development of agents to decompose
pesticides, and biodegradability and
toxicity standards—will prove effec-
tive in the nationwide program of pes-
ticide water quality criteria and stand-
ards which this amendment would
establish.
For instance, a report published
this month by the American Chemical
Society described in detail a number
of means by which the massive pesti-
cide contamination can be minimized.
I believe it would be helpful to out-
line some of the information provided
by this and other reports which we
have studied.
First, since pesticides have been
billed as a panacea for controlling all
pests, heavy application has become
a national habit, whether it is needed
or not. For example, cotton is often
sprayed with toxic, persistent pesti-
cides every 5, 7, or 10 days.
BETTER PESTICIDE USE
Yet, with effective use of our
improved knowledge of the life cycle
and behavior of both the crop and the
pest, pesticide application could be cut
down to only that period of the time
when a pest is in fact endangering a
crop.
In addition, acceptance of the valid
idea that 100-percent pest control need
not be achieved would further cut pes-
ticide use. Often, damage to crop pro-
duction could be prevented with just a
75-percent control of the pests.
Another valid application method
which would further cut pesticide use,
expense, and pollution, is treating only
the areas that are heavily infested with
pests. As an example, mountain water
in North Carolina was found to con-
tain more than 0.3 part per billion of
DDT when an entire oak-hickory for-
est was treated for a tree disease.
Later, when only the region of the
forest affected by the disease was
treated, it was impossible to find any
trace of DDT in the waters. And the
disease was still controlled.
If improved application equipment
were used, there would be another sig-
nificant reduction in pesticide use.
A Mississippi study on the aerial
application of the persistent pesticide
heptachlor showed that only 17 per-
cent of the compound was applied at
the proper rate on the crop. The
remainder either missed the crop, was
applied at a rate much lower than
-------
1308
LEGAL COMPILATION—PESTICIDES
necessary, or was applied at a rate
much higher than necessary. In
another study, only 10 to 20 percent of
a pesticide dust reached the plant, with
the remainder missing its target
entirely.
Concentrated efforts to eradicate
whole pests populations also offer
great promise. For example, if just
three pests, the boll weevil, the boll
worm, and the codling moth, were erad-
icated, it would be possible to reduce
the amount of insecticides applied
each year in the United States by some
40 percent.
BIOLOGICAL CONTROL
Insect sterilization has become one
of the most effective ways to eliminate
a total insect population. This was the
technique that was used to eradicate
the screw-worm fly from the South-
east United States. The U.S. Depart-
ment of Agriculture raised millions
of screw-worm flies weekly, with radio-
active cobalt used to make the flies
reproductively sterile.
Massive numbers of sterilized flies
were air dropped regularly over
thousands of square miles infested by
native screw-worm flies. The sterile
flies mated with the native females,
and the resulting eggs failed to hatch.
Repeated releases of sterile flies
reduced screw-worm numbers, until
the pests finally disappeared.
Presently, the Agriculture Depart-
ment is maintaining a barrier zone
along the United States-Mexico border
to keep out new screwworms though
continuously releasing sterile flies
along that area.
The American Chemical Society
says that the ideal pesticide should be
as effective as possible against one or
several pests and as safe as possible
to all other forms of life, including
beneficial insects and predators, fish
and other wildlife, domestic animals,
and man. As one of its main recom-
mendations in its recent report, the
Society urged:
Persistent pesticides should only be used
in minimal amounts snd under conditions
where they have been shown not to cause
widespread contamination of the environment
Where possible, highly persistent materials
should be replaced by rapidly degradable ma-
terials.
The feasibility of this approach is
demonstrated by the fact that, as
pointed out earlier, for virtually all
crops, there are several pesticides,
some very persistent and some not,
which can effectively control harmful
pests.
In several parts of the country, the
cost of pesticide use has increased so
drastically, that other systems of pest
control with little or no reliance on
chemical formulations have been adop-
ted with great success.
INTEGRATED PEST CONTROL
Among these approaches is inte-
grated pest control, which can be best
defined as an insect population man-
agement system that depends primar-
ily on the use of beneficial predator
insects with limited reliance on the
use of selective chemicals.
Presently there are successful inte-
grated pest control programs in opera-
tion on the following crops: cotton,
citrus fruits, apples and pears,
tomatoes, potatoes, avocadoes, olives,
grapes, corn, eggplant, lettuce, straw-
berries and others.
This means of pest control is based
on the principles of applied ecology.
In order for success to be achieved, the
fields must be placed under periodic
surveillance to determine when and
where specific pest infestations occur.
When & problem is discovered, preda-
[p. 28994]
tors, parasites, or disease organisms
specifically related to that pest are
released to bring the pests back
into a favorable balance. Very limited
amounts of pesticide may be used, but
only when absolutely necessary, and
only on the infested area of the crop.
While many farmers and other
pesticide users resist giving up chemi-
-------
STATUTES AND LEGISLATIVE HISTORY
1309
cal means of pest control because they
feel that other alternatives may be
more costly, the opposite has been
proven true with regard to integrated
pest control.
LOWER COST
Prof. Robert VandenBosch of the
College of Agricultural Sciences, Uni-
versity of California at Berkeley, cites
this example: The cost of pest control
using chemical pesticides for 4,000
acres of cotton in California was
$185,000. When integrated pest con-
trol replaced the use of chemical pes-
ticides, the cost dropped to $20,000 a
year. The statistics for spotted alfalfa
in California are very similar, where
in 1957, the cost of pest control with
chemical pesticides was at least $12
million. Today, after the introduction
of integrated pest control, the cost has
been reduced to only $3 million, with
little or no pest problems remaining.
A recent edition of the Western
Fruit Grower cites additional cases of
the successful and economical appli-
cation of integrated pest control in
place of the use of chemical pesticides.
One expert in biological control has
enabled a producer of Valencia
oranges to reduce the cost of pest con-
trol from $200 per acre, using chemi-
cal control, to only $60 an acre with
integrated pest control. Another
orange grower has been able to reduce
his cost per acre for pest control to
just $35 per acre, using integrated
pest control, and has had higher yields
than ever in the history of the grove.
Another pest control approach
showing major promise is the use of
hormones. The principle is to give an
insect its own hormone at the wrong
stage of its life, so that it upsets the
bug's growth processes and causes it
to destroy itself.
Finally, the search is now under-
way for a catalyst which would cause
DDT to self-destruct after it had
accomplished its insect control tasks.
If successful, this would be a major
breakthrough in dealing with the ten-
dency of hard pesticides to persist in
the environment long after they are
needed. Secretary of the Interior
Walter Hickel recently announced the
award of a contract to test this
approach.
America and the world cannot afford
to wait much longer to decide that
hurling the crude weapon of hard pes-
ticides against the fabric of life, the
apt description by Rachel Carson, is
not the answer to our pest control
problems.
Our approach must be much more
sophisticated than that, and as I have
outlined above, there is an abundance
of alternatives. And there is no rea-
son why the job cannot be done more
effectively and far more economically
than the present massive, indiscrimi-
nate pesticide use. The savings would
accrue to the farmer and all other
pesticides users, to our environment,
and most importantly, to future gener-
ations of life on earth.
I believe the pesticide amendment
to S. 7 is a major step in the right
direction. Criteria would be developed,
standards would be set and imple-
mented, and the means to meet these
standards brought into use.
I urge the Senate's adoption of the
amendment, and I am heartened and
deeply appreciative of the cosponsor-
ship of this proposal by 31 Senators,
including the chairman of the Senate
Public Works Committee, Senator
RANDOLPH, and the chairman of the
Subcommittee on Air and Water Pol-
lution, Senator MUSKIE, who is the
author of S. 7.
This board support is without ques-
tion a confirmation of the growing
insistence of Congress that the quality
of the American environment and the
quality of life for all Americans be
given the protection that is so urgently
needed.
-------
1310
LEGAL COMPILATION—PESTICIDES
EXHIBIT 1
U.S. DEPARTMENT or THE INTERIOR
FEDERAL WATER POLLUTION CON-
TOOL ADMINISTRATION
Washington, D.C., Augutt 25, 1969.
HON. GAYLORD NELSON,
U.S. Senate.
Washington, D.C.
DEAR SENATOR NELSON: In accordance -with
Mr. John Heritage's recent request by tele-
phone to Mr. Bern Wright of our Water Qual-
ity Standards Branch, a review has been made
of the States' water quality standards require-
ments on pesticides and the following informa-
tion and enclosed summaries are being pro-
vided for your use.
Most of the State standards contain one or
more requirements by which limits on specific
toxic substances may be imposed on a case-by-
case basis. These controls are found in the
standards in the form of a general narrative
statement on toxicity, or they may be included
in the public water supply or aquatic life use
criteria. Three of the States have specific nu-
merical limits for pesticides and at least two
others specifically mention pesticides in their
toxicity standards.
SPECIFIC NUMERICAL STANDARDS ON
PESTICIDES
Alaska.
Standards of the State of Alaska contain a
pesticide limit of 0.001 of the 96-hour LCso.
(96-hour LCso means the lethal concentra-
tion of a substance that will result in a 60%
kill of the test organism in a 96-hour period.)
California
Tidal Waters Inland from the Golden Gate
within the San Francisco Bay Region — No
individual pesticide or combination of pesti-
cides shall reach concentrations found to be
deleterious to fish or wildlife at any place.
Goose Lake — The total chlorinated hydro-
carbon pesticide content shall not exceed 0.10
micrograms per liter as determined by the
summation of the individual concentrations,
and the individual pesticide content shall not
reach those levels found to be detrimental to
aquatic life and wildlife.
Idaho
Toxic or Other Deleterious Substances (pes-
ticides, phenolica and related organic and in-
organic materials)—Toxic chemicals of other
than natural origin in concentrations found
to be of public health significance or adversely
affect the uses indicated. Guides such as the
Water Quality Criteria published by the State
of California Water Quality Control Board,
Second Edition, 1963, will be used in evaluat-
ing the tolerances of the various toxic chemi-
cals for the use indicated.
South Dakota,
Pesticides, herbicides and related compounds
shall be treated as toxic materials and taste
and odor producing chemicals and controlled
under the provisions of Chapter II, Section
II, Subsection 2 and 4.
Chapter II, Section II. Subsection 2—Toxin
Materials. No materials shall be discharged to
any surface water or watercourse in the State
which produce concentrations of chemicals
toxic to humans, animals or the most sensitive
stage or form of aquatic life greater than 0.1
times the acute (96-hour) median lethal dose
for short residual compounds or 0.01 times the
acute median lethal dose for accumulative sub-
tances or substances exhibiting a residual life
exceeding 30 days in the receiving waters.
Chapter II, Section II, Subsection 4—Taste
and Odor Producing Chemicals. No materials
shall be discharged which will result in con-
centrations in the receiving water sufficient to
impart objectionable tastes and odors to edible
aquatic life.
Virginia
Salt water (shellfish)—Area is not to be so
contaminated with radionuclides, pesticides,
herbicides or fecal material, that consumption
of the shellfish might be hazardous.
PUBLIC WATER SUPPLY CRITERIA
Several States have included the Public
Health Service (PHS) Drinking Water Stan-
dards as requirements for establishing tne
quality of water to be maintained as an accept-
able source of public water supply. These stan-
dards establish a limit of 0.2 mg/1 for Carbon
Chloroform Extract (CCE). This is intended
to be a general safety control for the detection
of "ill defined" chemicals which could include
pesticides. The CCE control is not intended for
replacement of specific limits on pesticides and
other toxic substances.
Those States which expressly include the
PHS requirements for waters designated for
public water supply use are as follows: Ala-
bama, Alaska, California, Connecticut, Geor-
gia, Maine, Michigan, Minnesota, Montana,
Nebraska, North Carolina, Rhode Island, Ver-
mont, West Virginia, Wyoming.
AQUATIC LIFE-TOXICITY STANDARDS
All of the States' standards provide for the
protection of aquatic life from toxic sub-
stances. Appendix A is a summary of these
requirements as they relate to aquatic life.
A copy of the "Report of the Committee on
Water Quality Criteria—Federal Water Pollu-
tion Control Administration" is also enclosed
for your reference use. Pages 56, 68, 59 of this
report provide discussions on "Toxic Sub-
stances" and "Bioassay" which may be help-
ful to you in interpreting the standards on
toxic substances. You will also find on pages
62-66, 82-83, 116, 118, 131, 137, 166 of this
report information on pesticides. Each of the
-------
STATUTES AND LEGISLATIVE HISTORY
1311
State water pollution control agencies have
been provided a copy of this report and it is
being widely used by the States as a guide in
the updating of their water quality standards.
If you have any further questions concern-
ing specific requirements in the standards,
please let me know.
Sincerely yours,
DAVID D. DOMINICK,
Commissioner.
APPENDIX A—TOXICITY STANDARDS For
Surface Waters Used for FISH PROPAGA-
TION AND WILDLIFE
(Toxic substances—Maximum allowable
(me/D)
Alabama: Only amounts not injurious to
fish and aquatic life, including shrimp and
crabs, or the propagation thereof. 1/10 of 48-
hour TLm or other approved limits.
Alaska: Less than acute or chronic problem
levels as revealed by bioassay. None which
causes tainting of flesh of edible species.b
Pesticides: 0.001 of 96-hour LCsob.
Arizona: Biocide concentrations shall be
[p. 28995]
kept below levels which are deleterious to
human, animal, plant, or aquatic life, or in
amounts which interfere with this use.
Arkansas: Shall not be present in quanti-
ties toxic to human, animal, plant, or aquatic
life or which interfere with the normal propa-
gation of aquatic life. 1/10 of 48-hour TLm.
California: At all times less than the con-
centrations toxic or harmful to wild or domes-
tic animals or to aquatic life.
Colorado: Free from biocides, toxic, or
other deleterious wastes in concentrations or
combinations sufficient to be harmful to aqua-
tic life.
Connecticut: Free from chemical constitu-
ents in concentrations or combinations which
would be harmful to human, animal, or aqua-
tic life. Bioassays shall be performed as needed.
Delaware: None in concentrations harmful
(synergistically or otherwise) to humans, fish,
wildlife, and aquatic life.
District of Columbia: None from waste
sources in concentrations or combinations
which are harmful to human, animal, plant,
or aquatic life or which interfere with this use.
Florida: Free from waste substances toxic
or harmful to human, animal, or aquatic life.
F: 10.0 Cu-O.B, Zn-1.0, Cr6-0.06, Pb-0.06,
Fe-0.3, As-0.05. Cn: none detectable.
Georgia: None in concentrations that would
harm man, fish and game, or other beneficial
aquatic life.
Territory of Guam: Free from waste mate-
rials that will be toxic or irritating to humans,
animals, plants, or aquatic life.
Hawaii: Free from biocides, toxic, or other
Footnotes at end of article.
deleterious substances in concentrations harm-
ful to human, animal, or marine life, or which
cause unpleasant taste in seafood.
Idaho: No toxic chemicals of other than nat-
ural origin, in concentrations of public health
significance or which adversely affect this use.
Illinois: 1/10 of 48-hour TLm, As-1.0, Ba-
6.0 Cd-O.OB, Cr6-0.05, Cr3-1.00, Cu-0.04, Cn-
0.025, Pb-0.1, Ag-0.05, An-1.00.
Indiana: 1/10 of 96-hour TLm from continu-
ous-flow bioassays where the dilution water
and toxicant are continuously renewed, or
other factors when justified and approved.
Iowa: NHs-2.0. As-1.0, Ba-5.0, Cd-0.06,
Cr«-0.06, Cri-1.00, Cu-0.02, Cn-0.026. Pb-0.10,
Zn-1.0. Maximum of 5.0 for entire heavy
metal group.
Kansas: Pollutional substances will be main-
tained below maximum permissible concentra-
tions which would be detrimental for recrea-
tional requirements.
Kentucky: 1/10 of 48-hour TLm. Free from
waste substances in concentrations or combi-
nations which are toxic or harmful to human,
animal, plant, or aquatic life.
Louisiana: 1/10 of 48-hour TLm. None pres-
ent in quantities that alone or in combination
will be toxic to animal or plant life.
Maine: No chemical constituents from waste
sources, which are harmful to humans, animal,
or aquatic life, or which adversely affect this
use.
Maryland: Free from toxic wastes which
interfere with this use or which are harmful
to human, animal, plant or aquatic life.
Massachusetts: None at levels harmful to
human, animal, or aquatic life, or which make
the waters unsuitable for fish or their propaga-
tion, or impair their palatability.
Michigan: 1/10 of 96-hour TLm, from con-
tinuous flow bioassays.
Minnesota: Cr-tr, Cu-tr, Cn-tr, NH3(N)-
trbl, Cr-1.0, Cu-0.2, Cn-0.02, NH3(N)-1.0<=,
Cr-1.0, Cu-0.2, Cn-0.02, NH3(N)-2.0<. None
directly or indirectly harmful."
Mississippi: 1/10 of 48-hour TLm.
Missouri: None which have harmful effect
on human or animal life.
Montana: 1/10 or 96-hour TLm for short
residual materials and 1/100 of 96-hour TLm
for pesticides.
Nebraska: None in combinations or con-
centrations which render the water unsafe or
unsuitable for this use.
Nevada: None present in concentrations,
from other than natural origin, which are
deleterious to animal, plant, or aquatic life,
or which exceed the 1962 PHS "Drinking
Water Standards."
New Hampshire: None in toxic concentra-
tions or combinations. Free from chemicals and
conditions inimical to fish or the maintenance
thereof.
New Jersey: None which would affect hu-
-------
1312
LEGAL COMPILATION—PESTICIDES
mans or be detrimental to the natural aquatic
biota.
New Mexico: 1/10 of 48-hour TLm. Shall
not change the ecology to an extent detrimen-
tal to existing forms of life nor be toxic to hu-
mans, plants, fish, or animals.
New York: None alone or in combination
with other substances or wastes in sufficient
amounts to be injurious to fish life or impair
the water for this use.
North Carolina: 1/10 of 48-hour TLm. Shall
not change the ecology to an extent detrimen-
tal to existing forms of life nor be toxic to
humans, plants, fish, animals.
North Dakota: No waste materials, either
in concentrations or combinations, which re-
sult in the waters being toxic or harmful to
human, animal, or aquatic life.
Ohio: 1/10 of 48-hour TLm. Free from waste
substances in concentrations or combinations
which are toxic or harmful to human, animal,
or aquatic life.
Oklahoma: 1/10 of 48-hour TLm. Shall not
be present in such quantities as to cause the
•waters to be toxic to human, animal, plant, or
aquatic life.
Oregon: No conditions deleterious to fish or
other aquatic life or which affect the palata-
bility of fish.
Pennsylvania: None in amounts sufficient to
be inimical or harmful to this use.
Commonwealth of Puerto Rico: None alone
or in combination with other substances or
wastes in amounts injurious to edible fish or
their culture, taste, or propagation.
Rhode Island: Bioassays shall be performed
as required by the appropriate agencies. None
which would be harmful to human, animal, or
aquatic life.
South Carolina: Free from waste materials
which are toxic or harmful to human, animal,
plant, or aquatic life, or which interfere direct-
ly or indirectly with this use.
South Dakota: 1/10 of 96-hour TLm for
short residual compounds. 1/100 of 96-hour
TLm for substances of residual life exceeding
30 days. Cn-02"""''* 0.06h.
Tennessee: There shall be no substances
added that will produce toxic conditions that
affect fish or aquatic life.
Texas: Shall not exhibit acute or chronic
toxicity to human, animal, or aquatic life to
such an extent as to interfere with this use.
Utah: No waste materials in concentrations
or combinations which are toxic or which pro-
duce undesirable physiological responses in
humans, fish, and other animal life, and plants.
Vermont: Bioassays shall be performed, in-
cluding assessment of taste and odor. Free
from chemical constituents harmful to human,
animal, or aquatic life.
Virginia: Free from toxic substances at-
tributable to waste, in concentrations or com-
binations which interfere directly or indirectly
with this use.
Virgin Islands of the United States: Free
from waste substances in concentrations or
combinations which are toxic or harmful to
human, animal, or aquatic life.
Washington: Below concentrations which
may cause acute or chronic toxic conditions to
the aquatic biota.
West Virginia: No concentrations of mate-
rials poisonous to man, animal, or fish life.
Wisconsin: None present in amounts which
by bioassay or other tests indicate acute or
chronic levels harmful to animal, plant, or
aquatic life.
Wyoming: Free from toxic substances of
other than natural origin in concentrations or
combinations which are toxic to human, ani-
mal, or aquatic life.
FOOTNOTES
b Standard reserved from approval by
FWPCA.
" Applies to propagation and maintenance
of warm and coldwater sport or commercial
fishes.
62 Standards apply only to coastal waters.
e Applies to propagation and maintenance
of sport and commercial fishes.
d Applies to propagation and maintenance
of fish species common to the area waters.
*' Fish life propagation—coldwater perma-
nent.
« Applies to use by wildlife.
•J Fish life propagation—coldwater mar-
ginal
1 Fish life propagation—warmwater perma-
nent.
s Fish life propagation—warmwater semi-
permanent.
h Fish life propagation—warmwater mar-
ginal.
Mr. RANDOLPH. Mr. President,
will the Senator yield?
Mr. NELSON. I yield to the Sena-
tor from West Virginia.
Mr. RANDOLPH. Mr. President,
the Senator from Wisconsin has often
appeared before the Committee on
Public Works and its subcommittees
in reference to the matters of cleansing
the air and purifying the water. I
will not mention the long list of affirm-
ative actions he has initiated in the
Senate. I am not sure how many
cosponsors on the amendment, but I
do know there is a considerable list.
I am delighted I could join him in the
amendment.
In the joining with him we recognize
his leadership in this field. I think his
explanation this afternoon of the pres-
-------
STATUTES AND LEGISLATIVE HISTORY
1313
ence of pesticides and the danger that
can be wrought by this type pollution
is a real one. I express my thanks for
his constructive efforts.
Mr. NELSON. I thank the distin-
guished chairman of the Committee on
Public Works for his gracious
remarks. I might add, however, the
reason I appeared before the Commit-
tee on Public Works, of which the
Senator from West Virginia is chair-
man, is that that committee has been
doing such extensive work in the field
of enhancing the quality of air and
water in this country. They have made
it possible for conservationists and
Members of Congress to appear in con-
nection with legislation of this nature
to which his committee has devoted so
much time.
Mr. MONDALE. Mr. President, I
rise in support of the amendment (No.
132) introduced by the Senator from
Wisconsin (Mr. NELSON) to S. 7.
I have already stated the many rea-
sons that I support the Water Quality
Improvement Act of 1969, and I
appreciate this opportunity to direct
specific remarks to the amendment
now proposed by my distinguished
colleague from Wisconsin.
Under the proposed amendment, the
Secretary of the Interior is directed
to take certain steps that would guar-
antee water quality criteria for all
pesticides. The criteria would be based
on the effects of various pesticide lev-
els on fish and wildlife, as well as man
and his environment. The criteria
would outline maximum safe levels
for the presence of pesticides in water,
and these would represent the essen-
tial basis for State or Federal action
[p. 28996]
to deal with the pesticide pollution
problem.
It is clear that persistent pesticides
are so polluting our rivers, lakes,
streams, and oceans that fish can and
have been killed; that fish reproduc-
tion can and has been inhibited; that
high pesticide residues in water have
affected birds and other animals; and,
that now, even man is threatened.
Specifically, the amendment would
permit the Secretary of the Interior,
after consultation with all interested
and concerned parties, to prepare and
publish regulations setting forth water
quality standards for pesticides that
will clearly not have a deleterious
effect on fish or man. Responsibility
for enforcing the standards would
rest primarily with the States. Stand-
ards could be implemented by issuing
orders to polluters to take remedial
measures.
A particularly significant aspect of
this amendment is that it permits the
establishment of a system for tabu-
lating, monitoring, and recording pre-
cisely what pesticide residues should
be permitted.
As chairman of the Senate Sub-
committee on Migratory Labor, I have
become particularly aware of the need
to establish similar procedures inso-
far as farmworkers may be affected
by pesticide use.
There is mounting evidence con-
cerning the harmful effects of pesti-
cides on our Nation's migrant and
seasonal farmworkers. Experts from
the Department of Health, Education,
and Welfare concede that perhaps as
many as 800 farmworkers are killed
and 80,000 injured by pesticides each
year. We know that the agricultural
industry experiences one of the high-
est occupational disease rates in the
United States. Just last week we
learned that a substantial proportion
of farmworkers experience symptoms
of chemical poisoning which include
dermatitis, rashes, eye irritation, nau-
sea, vomiting, fatigue, excess sweat-
ing', headaches, double vision, dizzi-
ness, skin irritations, difficulty in
breathing, loss of fingernails, ner-
vousness, insomnia, bleeding noses,
and diarrhea.
It is clear from our hearings that
proper safeguards and protections for
farmworkers do not exist in the use
-------
1314
LEGAL COMPILATION—PESTICIDES
of pesticides. In fact, under the pres-
ent State and Federal regulations,
information about how, when, and
where chemicals are used is seldom
available to the farmworker or to the
public.
The hearing record is painfully lack-
ing in any firm evidence that the pes-
ticides to which farmworkers are daily
exposed in fact have no deleterious
short- or long-range effects on their
health and well-being. Further, it was
shocking to learn of the pitifully inad-
equate funding of programs devoted
to research on occupational hazards
to farmworkers; and to discover that
programs aimed at protecting the
farmworkers are neither adequately
funded nor enforced.
We do know, however, from recent
accounts in medical and scientific
journals, that the wrong kinds of
chemicals, in the wrong amounts, and
in the wrong places are sometimes
used with inadequate regard of the
health and safety of their workers.
Furthermore, we know that recent
scientific investigations have produced
evidence that DDT causes cancer in
animals and provides very strong indi-
cations that DDT may produce can-
cer in man.
Mr. President, I support this amend-
ment, because it establishes a mecha-
nism for the Secretary of the Interior
to determine maximum safe levels of
pesticides in water that would repre-
sent the essential basis for action to
deal with the pesticide pollution prob-
lem in water. Additionally, enactment
of this amendment may serve as a
workable model for necessary legisla-
tion to protect farmworkers through
establishment of a meaningful system
for monitoring pesticide effects on
man.
Mr. MUSKIE. Mr. President, the
amendment offered by the Senator
from Wisconsin (Mr. NELSON) is a
constructive addition to the legislation
which is pending before the Senate.
I have discussed this proposal with
the Senator from Wisconsin and agree
with the need to provide the Secretary
of the Interior with a specific direc-
tive te formulate criteria which indi-
cate the effects of pesticides on the
water environment.
There is a growing national con-
cern regarding the use of pesticides.
Conservationists, scientists, medical
experts, and ecologists are speaking
out against indiscriminate use of pes-
ticides while other scientists, health
officials, and agricultural experts
oppose actions to limit their availa-
bility and use.
Existing information is sufficient to
suggest that we have not exercised
due care in either the amount or type
of pesticides we use. Inadequate atten-
tion has been paid to developing less
toxic more degradable pesticides and
thus, today, we are confronted with
the potential of banning entirely the
use of some materials which have
been extremely helpful in expanding
the Nation's productivity and pro-
tecting the Nation's health.
I am not prepared, at this time, to
suggest that all pesticides, herbicides,
fungicides, and insecticides should be
banned or even that some of them
should be banned. I support Senator
NELSON'S amendment because we need
to know a great deal more about the
health and welfare effects of these pol-
lutants and because existing scientific
information needs to be assembled
and evaluated.
The criteria to be published by the
Secretary should provide useful assist-
ance to the States in determining the
extent to which the use of pesticides
and water quality requirements are in
conflict.
In some States it may be necessary
to establish limitations on the avail-
ability of certain types of pesticides
and, in other cases, it may be neces-
sary to limit use of specific pesticides
in certain watersheds. Whatever
course is taken in controlling use of
persistent pesticides, care should be
-------
STATUTES AND LEGISLATIVE HISTORY
1315
taken to assure the public health re-
sponsibilities such as malaria control
are not hindered.
Enforcement procedures must con-
sider the differences between point
source control available to municipal
and industrial wastes as opposed to
the general diffusion of the pollutant
in this case. The inability to effectively
control this type of pollutant after
application suggests the need to con-
sider legislation which will establish
uniform standards on the biograda-
bility and toxicity of pesticides to
assure environmental protection prior
to the indiscriminate introduction of
pesticides into the environment.
The Senator from Wisconsin (Mr.
NELSON) has indicated an intent to
introduce such legislation in the near
future. I will cosponsor his proposal
and the Subcommittee on Air and
Water Pollution will hold hearings
early next year.
I would like to ask the distinguished
Senator this question. First of all I
share the Senator's concern about the
growing dilemma of pesticide pollu-
tion. In many ways I think it is per-
haps the most serious in its potential
impact upon the environment, upon
wildlife, and upon human life itself.
It is the most persistent and most
difficult to come to grips with once
pesticides are released in the envi-
ronment. In that sense, it is like air
pollution. Once discharged, it cannot
be controlled; so, as in the case of
pesticides at the dispersal point.
Since the problem of control is, for
that reason, somewhat different from
that of air pollutants, the enforce-
ment problem is different in the same
way. So we have to come to grips with
that problem.
The amendment offered by the dis-
tinguished Senator from Wisconsin is
a major advance, I think, toward
restoring and preserving the quality
of our waters that are now threatened
by pesticides.
In addition to leading to specific
standards for safe concentrations of
pesticides in interstate rivers and
lakes, I believe that the amendment
serves an equally important purpose
of establishing a comprehensive pro-
gram for research in the Department
of the Interior, to study the problems
of persistent pesticides and alterna-
tives that can eliminate this contami-
nation of our environment.
That is the point which, I think, is
at the heart of resistance to the con-
trol of pesticides.
I ask the Senator from Wisconsin
whether he believes that the standards
that would be developed as a result of
his amendment can be met without
hindering efforts to control insects,
weeds, fungus, and other pests that
can cause damage to farmers and can
pose a potential hazard to human
health.
Mr. NELSON. I do not think there
is any question about that. No Mem-
ber of Congress is more familiar with
the Water Pollution Control Act than
the Senator from Maine (Mr. MUSKIE)
who conducted the hearings, drafted
the bill, and engineered its passage in
the Senate.
As the Senator knows, under sec-
tion 10 (c) the Secretary can estab-
lish criteria, but he must consider the
practicability and the economic feasi-
bility of any standards that are pro-
posed to be used. He must take these
factors into consideration.
I make one other point. The Depart-
ment of Agriculture prescribes an
alternative pesticide for every chlor-
inated hydrocarbon, so far as I can
ascertain, that is listed for use on
virtually every crop in this country. In
other words, there is another, more
readily degrading pesticide that is
readily available. As I review the
application rates recommended by the
[p. 28997]
Department and the current prices of
pesticides, the cost of hard pesticides
compared with readily degradable
pesticides is roughly the same.
-------
1316
LEGAL COMPILATION—PESTICIDES
I believe that the Senator knows
Michigan and Arizona have already
banned the use of DDT. My own State
of Wisconsin is moving to drastically
improve the controls on it and has
created a board to determine if it is
necessary to use certain pesticides.
There is integrated pest control which
has been initiated successfully in Cali-
fornia in which they do not indiscrim-
inately spray the crop. They use
whatever biological methods they can,
including certain organisms which
prey on insects. But whatever method
they use, biological or chemical, it is
limited to the area where the pest is.
In my earlier remarks, I outlined
those programs and the cost per acre,
which is dramatically less for a pro-
gram of integrated pest control.
Unfortunately, so many people just
hire an airplane and go out and spray
indiscriminately all over the place.
So in answer to the Senator, I
believe that many practical, alterna-
tive means are available right now.
But again I say, the Secretary must
consider the practicability and the
economic feasibility for any standards.
So that is the protection against arbi-
trariness on anything he may propose.
Mr. MUSKIE. That is the value of
the Senator's amendment. It increases
the pressure to recognize the avail-
ability of other means of controlling
pests than with hard pesticides. If we
do not concentrate on that and enlarge
the possibilities in this respect, we will
be wasting, perhaps, the last chance
we will have to avoid the massive dis-
persal of hard pesticides into the
environment.
I am delighted to cosponsor the
amendment. I compliment the Senator
on becoming, in my judgment, the most
knowledgeable expert in the Senate on
this problem.
Mr. NELSON. Mr. President, inci-
dentally, I might say to the Senate,
that my staff and the staff of the Sena-
tor from Maine will get together and
develop a legislative proposal estab-
lishing standards for the components
of pesticides, taking into consideration
their persistence, degradability, and
toxicity. This is the next step that
must follow so that we can determine
if pesticides, like detergents, should
be subject to certain standards in
order to protect the environment.
Mr. MUSKIE. I thank the Senator.
Mr. TYDINGS. Mr. President, as a
cosponsor of amendment No. 132, I
congratulate the junior Senator from
Wisconsin (Mr. NELSON) for his tire-
less efforts to call attention to the
environmental danger stemming from
the widespread and often indiscrimi-
nate use of persistent pesticides.
Toxic residues of these chemical
compounds are showing up in our air
and water, and, through the multi-
plying effect of the food chain, in
human beings as well.
The effect of these poisons on fish
and wildlife are well known. Our ani-
mal resources can be killed outright,
as the Coho salmon were, or face grad-
ual destruction, if not extinction, as
are the brown pelican and the bald
eagle.
The effect of pesticide residues on
man are not yet fully known. Pres-
ently there is no evidence that the
increasing amounts of pesticides in
fact harm human beings. Yet common
sense tells us that absorbing poisonous
chemicals is not healthy.
The long-term health impact on man
of persistent pesticides may well be
most damaging.
Mr. President, in late July I intro-
duced wide ranging pesticide protec-
tion legislation. The bill, S. 2747,
directs the Secretary of Health, Edu-
cation, and Welfare to make a com-
plete study of the use and effects of
pesticides. It transfers the pesticide
regulatory functions from the Depart-
ment of Agriculture to the Depart-
ment of Health, Education, and Wel-
fare. It removes the exemption from
registration and labeling of those pes-
ticides intended solely for export.
-------
STATUTES AND LEGISLATIVE HISTORY
1317
Finally, the bill places a 4-year mora-
torium on four of the more persistent
and powerful pesticides.
It is perhaps the most comprehen-
sive legislation on pesticides yet intro-
duced in the Senate. But it is unlikely
to go anywhere and now will serve
only as a point of discussion.
Yet what is required now is not
just talk but action as well. Senator
NELSON'S amendment is the first step
toward protecting our environment
from toxic pesticides. I fully support
his amendment and again congratu-
late the Senator for alerting us to the
threat.
Mr. HART. Mr. President, I am
very pleased to cosponsor Senator
NELSON'S amendment to S. 7 which
would require the Secretary of the
Interior to develop water quality cri-
teria for pesticides. These criteria
would then be used by the States as a
basis for the adoption of standards
to effectively control pesticide pollu-
tion of our lakes and rivers.
As with most of our clean water
efforts, the need to develop standards
which will help to reduce the quantity
of persistent pesticides entering our
water is long overdue. For many years
scientists have been warning that the
large-scale and indiscriminate intro-
duction of these chemicals into our
environment may be doing serious
harm. But only today are people gener-
ally beginning to realize that although
agricultural production has increased
and disease control has been improved
through the use of persistent pesti-
cides, these short-term gains may have
been purchased at the price of irre-
versible disruption of many ecological
systems.
The so-called magnification effect of
pesticides on fish and wildlife has now
been well documented. Fish, feeding
on miscroscopic organisms which con-
tain persistent pesticides, assimilate
these chemicals into their own sys-
tems. In addition, through normal gill
action, a fish appears to effectively fil-
ter pesticides directly from the water.
In both cases, the pesticide is stored
up in the body fat of the fish where it
becomes increasingly more concen-
trated. Then, moving upward in the
food chain, each successive predator
assimilates greater and greater con-
centrations of these pesticides from
the smaller fish on which it feeds. Fish
at the end of the food chain, such as
the Lake Michigan coho salmon, now
contain DDT concentrations ranging
up to 19 parts per million, and fish-
eating birds, such as the osprey and
eagle, contain even higher levels of
this pesticide.
The effects of such concentrations of
persistent pesticides on fish and wild-
life are daily becoming better under-
stood. For example, Prof. Howard
Johnson of Michigan State University
has reported upon the reproduc-
tive problems DDT has created for
the Lake Michigan coho salmon.
Apparently the female salmon pass-
es some of the DDT on to her eggs
in concentrations ranging between
five and seven parts per million. After
the fry hatches from these eggs,
they begin to absorb the yolk sac,
but as they do, the DDT remaining
in the yolk becomes more and more
highly concentrated. At the last
stages of absorption, DDT concen-
trations become six to 12 times higher
than those in the actual body tissue
of the fry and this high level of DDT
has proven fatal to a high percentage
of the fry.
Slightly different problems have
occurred with fish-eating birds. Here
the high concentrations of DDT appar-
ently upset the bird's liver enzyme
balance and as a result affect its cal-
cium metabolism. The result has been
that these birds have produced eggs
which have exceptionally brittle shells.
In most cases the mother is unable to
hatch these eggs, because she acci-
dently breaks the shell. In one case
reported by the Audobon Society, an
embryo was born without a shell
-------
1318
LEGAL COMPILATION—PESTICIDES
altogether; it was encased only in a
membrane.
Last week the Commerce Commit-
tee's Subcommittee on Energy, Nat-
ural Resources, and the Environment,
which I chair, held field hearings in
Michigan to consider the effects of
pesticides on sports and commercial
fisheries. At these hearings Prof.
Joseph Hickey of the University of
Wisconsin commented on the serious
disruption which DDT has caused to
fish-eating bird populations. Brand-
ing DDT as the "compound of extinc-
tion," Professor Hickey stated:
In a series of closely integrated studies,
British, Canadian, and American scientists
have proven that similar reproductive fail-
ures (1) oecured in 1947 in peregrine
falcons; (2) involve fish-eating birds like bald
eagles, ospreys, brown pelicans, double-
breasted cormorants, and herring gulls; (3)
are producing regional extinction in some spe-
cies and continentally wide extinction in others;
and (4) are due to DDT. There is simply no
scientific doubt about these statements.
He then went on to state:
We have lost at least 95 per cent of our nest-
ing peregrine falcons—perhaps the supreme
example of avian evolution—in the United
States south of Canada, and we may very well
lose its entire subspecies in North America.
We are going to lose our national bird, the
bald eagle, as a nesting species on the shores
of the Great Lakes, not necessarily on inland
lakes. We have lost the brown pelican on the
west side of the Gulf of Mexico. And we will
lose it on the coast of California. These are
pollution effects due to DDT. The facts are
solid and the result of careful, painstaking
research.
[p. 28998]
Much more speculative at the pres-
ent time are questions about whether
consumption of DDT or other persis-
tent pesticides by man could seriously
harm his health or well-being. Never-
theless, the evidence of its harm to
birds and fish is sufficient to cause
grave concern. And recent research
efforts are beginning to produce addi-
tional disturbing results. For example,
earlier this year I released a report of
a study which had been conducted for
the National Cancer Institute. This
study revealed that when a group of
mice was fed a mixture containing 140
parts per million of DDT over a period
of 81 weeks, 63 percent developed tu-
mors. With a control group of mice,
only 16 percent developed tumors, in-
dicating that the mice exposed to DDT
were approximately four times more
likely to develop tumors than mice not
so exposed. In describing the DDT-
induced tumors, the report states:
It seems more reasonable to conclude that
the great majority had malignant potentiality.
In addition, at the Environmental
Subcommittee hearings on pesticides
which were held last May, we asked
the Food and Drug Administration
whether they could summarize some
of their work on the mutagenic effects
of pesticides. One of the investiga-
tions which they described involves a
study of 40 volunteers who are heavy
pesticide users and 20 control subjects
who are examined monthly to de-
termine what leukocyte chromosome
damage can be associated with the ex-
posure to pesticides. According to the
FDA:
Preliminary results indicate that during mid-
summer the exposed group had something
on the order of five times as many chromo-
some abberations as the control group. So far
this study has not been able to make com-
parisons between the groups at other times
of the year.
The Food and Drug Administration,
concerned with the results of the ex-
panding volume of research on pesti-
cides, has moved to set pesticide tol-
erances on many food products. In the
case of fish, an interim tolerance level
of five parts per mission has been es-
tablished. Although there is little ques-
tion that the FDA is taking proper
precautions in setting these toler-
ances, there is also little doubt that
this action will seriously disrupt, if
not destroy, the fishing industry on
Lake Michigan. The coho salmon can
no longer be marketed in interstate
commerce because of its high DDT
concentrations, and other commercial-
ly important fish which are lower
down in the lake's food chain, such as
-------
STATUTES AND LEGISLATIVE HISTORY
1319
the chub, now appear to be building up
DDT concentrations in excess of the
minimum FDA tolerances. Analyses
by the Michigan field office of the Bu-
reau of Commercial Fisheries indicate
that the DDT concentration in some
chubs now exceeds nine parts per mil-
lion. Lake Michigan lake trout, too,
also frequently contain concentrations
in excess of the FDA's minimum tol-
erances.
To preserve many of our country's
unique forms of life from extinction,
to reverse the grave ecological dam-
age which we are presently causing,
and to restore the vitality of our fresh-
water fisheries, it is imperative that
we begin now to upgrade the quality
of our water. Establishing water tol-
erance levels for pesticides—and then
rigidly enforcing these standards—is
an essential step toward this goal. We
should emphasize, however, that be-
cause very minute quantities of persis-
tent pesticides within water — meas-
ured in terms of parts per trillion—
cause severe harm to aquatic organ-
isms which concentrate these pesticides
within their systems, water quality
standards should be based on the pes-
ticide levels found in fish taken from
the water, and not on the water itself.
Only in this manner can we readily
determine when the amount of pesti-
cides in our waters is reaching danger-
ous levels.
Mr. President, I reiterate my great
pleasure in supporting this amend-
ment, and I earnestly hope that not
only is it adopted, but that meaningful
standards are forthcoming1 in the very
near future.
The PRESIDING OFFICER. The
question is on agreeing to the amend-
ment, No. 132, of the Senator from
Wisconsin.
The amendment was agreed to.
Mr. MUSKIE, Mr. President, I move
that the vote by which the amendment
was agreed to be reconsidered.
Mr. BYRD of West Virginia. Mr.
President, I move that the motion to
reconsider be laid on the table.
The motion to lay on the table was
agreed to.
Mr. NELSON. Mr. President, I ask
unanimous consent to have printed in
the RECORD a series of technical studies
taken from various scientific and con-
servation magazines.
There being no objection, the mate-
rial was ordered to be printed in the
RECORD, as follows:
[From Scientific American, March 1967]
Toxic SUBSTANCES AND ECOLOGICAL CYCLES
(By George M. Wood well)
The vastness of the earth has fostered a
tradition of unconcern about the release of
toxic wastes into the environment. Billowing
clouds of smoke are diluted to apparent noth-
ingness; discarded chemicals are flushed away
in rivers; insecticides "disappear" after they
have done their job; even the massive quanti-
ties of radioactive debris of nuclear explo-
sives are diluted in the apparently infinite
volume of the environment. Such pollutants
are indeed diluted to traces—to levels infini-
tesimal by ordinary standards, measured as
parts per billion or less in air, soil and water.
Some pollutants do disappear; they are im-
mobilized or decay to harmless substances.
Others last, sometimes in toxic form, for long
periods. We have learned in recent years that
dilution of persistent pollutants even to trace
levels detectable only by refined techniques Is
no guarantee of safety. Nature has ways of
concentrating substances that are frequently
surprising and occasionally disastrous.
We have had dramatic examples of one of
the hazards in the dense smogs that blanket
our cities with increasing frequency. What
is less widely realized is that there are global,
long-term ecological processes that concen-
trate toxic substances, sometimes hundreds of
thousands of times above levels in the envi-
ronment. These processes include not only
patterns of air and water circulation but also
a complex series of biological mechanisms.
Over the past decade detailed studies of the
distribution of both radioactive debris and
pesticides have revealed patterns that have
surprised even biologists long fam
-------
1320
LEGAL COMPILATION—PESTICIDES
Pacific were contaminated with fallout radia-
tion that would have been lethal to man. Japa-
nese and U.S. oceanographic vessels surveying
the region found that the radioactive debris had
been spread by wind and water, and, more
disturbing, it was being passed rapidly along
food chains from small plants to small ma-
rine organisms that ate them to large ani-
mals (Including the tuna, a staple of the
Japanese diet).
The U.S. Atomic Energy Commission and
agencies of other nations, particularly Britain
and the U.S.S.R., mounted a large interna-
tional research program, costing many mil-
lions of dollars, to learn the details of the
movement of such debris over the earth and
to explore its hazards. Although these studies
have been focused primarily on radioactive
materials, they have produced a great deal
of basic information about pollutants in gen-
eral. The radioactive substances serve as trac-
ers to show the transport and concentration of
materials by wind and water and the biologi-
cal mechanisms that are characteristic of nat-
ural communities.
One series of investigations traced the world-
wide movement of particles in the air. The
tracer in this case was strontium 90, a fission
product released into the earth's atmosphere
in large quantities by nuclear-bomb tests. Two
reports in 1962—one by S. Laurence Kulp and
Arthur R. Schulert of Columbia University
and the other by a United Nations commit-
tee—furnished a detailed picture of the trav-
els of strontium 90. The isotope was concen-
trated on the ground between the latitudes of
30 and 60 degrees in both hemispheres, but
concentrations were five to 10 times greater
in the Northern Hemisphere, where most of
the bomb tests were conducted.
It is apparently in the middle latitudes that
exchanges occur between the air of upper
elevations (the stratosphere) and that of lower
elevations (the troposphere). The larger tests
have injected debris into the stratosphere;
there it remains for relatively long periods,
being carried back into the troposphere and
to the ground in the middle latitudes in late
winter or spring. The mean "half-time" of
the particles' residence in the stratosphere
(that is, the time for half of a given injec-
tion to fall out) is from three months to five
years, depending on many factors, including
the height of the injection, the size of the
particles, the latitude of injection and the time
of year. Debris injected into the troposphere
has a mean half-time of residence ranging
from a few days to about a month. Once air-
borne, the particles may travel rapidly and
far. The time for one circuit around the earth
in the middle latitudes varies from 25 days
to less than 15. (Following two recent bomb
tests in China fallout was detected at the
Brookhaven National Laboratory on Long
Island respectively nine and 14 days after the
tests.)
Numerous studies have shown further that
precipitation (rain and snowfall) plays an
important role in determining where fallout
will be deposited. Lyle T. Alexander of the
Soil Conservation Service and Edward P.
Hardy, Jr., of the AEC found in an extensive
study in Clallam County, Washington, that the
amount of fallout was directly proportional to
the total annual rainfall.
It is reasonable to assume that the findings
about the movement and fallout of radio-
active debris also apply to other particles of
similar size in the air. This conclusion is sup-
ported by a recent report by Donald F. Gatz
and A. Nelson Dingle of the University of
Michigan, who showed that the concentration
[p. 28999]
of pollen in precipitation follows the same
pattern as that of radioactive fallout. This
observation is particularly meaningful be-
cause pollen is not injected into the tropo-
sphere by a nuclear explosion; it is picked up
in air currents from plants close to the ground.
There is little question that dust and other
particles, including small crystals of pesti-
cides, also follow these patterns.
From these and other studies it is clear that
various substances released into the air are
carried widely around the world and may be
deposited in concentrated form far from the
original source. Similarly, most bodies of
water — especially the oceans — have surface
currents that may move materials five to 10
miles a day. Much higher rates, of course, are
found in such major oceanic currents as the
Gulf Stream. These currents are one more
physical mechanism that can distribute pol-
lutants widely over the earth.
The research programs of the AEC and
other organizations have explored not only
the pathways of air and water transport but
also the pathways along which pollutants are
distributed in plant and animal communities.
In this connection we must examine what we
mean by a "community."
Biologists define communities broadly to
include all species, not just man. A natural
community is an aggregation of a great many
different kinds of organisms, all mutually in*
terdependent. The basic conditions for the
integration of a community are determined
by physical characteristics of the environ-
ment such as climate and soil. Thus a sand
dune supports one kind of community, •
freshwater lake another, a high mountain
still another. Within each type of environ-
ment there develops a complex of organisms
that in the course of evolution becomes a bal-
anced, self-sustaining biological system.
Such a system has a structure of interrela-
tions that endows the entire community with
a predictable development pattern, called "suc-
cession," that leads toward stability and en-
-------
STATUTES AND LEGISLATIVE HISTORY
1321
ables the community to make the best use of
its physical environment. This entails the
development of cycles through which the com-
munity as a whole shares certain resources,
such as mineral nutrients and energy. For
example, there are a number of different in-
puts of nutrient elements into such a system.
The principal input is from the decay of pri-
mary minerals in the soil. There are also cer-
tain losses, mainly through the leaching of
substances into the underlying water table.
Geologists view the cycles in the system as
mechanisms that have evolved to conserve the
elements essential for the survival of the or-
ganisms making up the community.
One of the most important of these cycles
is the movement of nutrients and energy from
one organism to another along the pathways
that are sometimes called food chains. Such
chains start with plants, which use the sun's
energy to synthesize organic matter; animals
eat the plants; other animals eat these herbi-
vores, and carnivores in turn may constitute
additional levels feeding on the herbivores and
on one another. If the lower orders in the
chain are to survive and endure, there must
be a feedback of nutrients. This is provided
by decay organisms (mainly microorganisms)
that break down organic debris into the sub-
stances used by plants. It is also obvious that
the community will not survive if essential
links in the chain are eliminated; therefore the
preying of one level on another must be lim-
ited.
Geologists estimate that such a food chain
allows the transmission of roughly 10 percent
of the energy entering one level to the next
level above it, that is, each level can pass on
10 percent of the energy it receives from below
without suffering a loss of population that
would imperil its survival. The simplest ver-
sion of a system of this kind takes the form
of a pyramid, each successively higher popu-
lation receiving about a tenth of the energy
received at the level below it.
Actually nature seldom builds communities
with so simple a structure. Almost invariably
the energy is not passed along in a neatly
ordered chain but is spread about to a great
variety of organisms through a sprawling,
complex web of pathways. The more mature
the community, the more diverse its makeup
and the more complicated its web. In a natural
ecosystem the network may consist of thou-
sands of pathways.
This complexity is one of the principal fac-
tors we must consider in investigating how
toxic substances may be distributed and con-
centrated in living communities. Other im-
portant basic factors lie in the nature of the
metabolic process. For example, of the energy
a population of organisms receives as food,
usually less than 50 percent goes into the con-
struction of new tissue, the rest being spent
for respiration. This circumstance acts as a
concentrating mechanism: a substance not
involved in respiration and not excreted effi-
ciently may be concentrated in the tissues two-
fold or more when passed from one popula-
tion to another.
Let us consider three types of pathways for
toxic substances that involve man as the ulti-
mate consumer. The three examples, based on
studies of radioactive substances, illustrate the
complexity and variety of pollution problems.
The first and simplest case is that of
strontium 90. Similar to calcium in chemical
behavior, this element is concentrated in bone.
It is a long-lived radioactive isotope and is a
hazard because its energetic beta radiation
can damage the mechanisms involved in the
manufacture of blood cells in the bone mar-
row. In the long run the irradiation may pro-
duce certain types of cancer. The route of
strontium 90 from air to man is rather direct:
we ingest it in leafy vegetables, which ab-
sorbed it from the soil or received it as fallout
from the air, or in milk and other dairy prod-
ucts from cows that have fed on contami-
nated vegetation. Fortunately strontium is not
usually concentrated in man's food by an ex-
tensive food chain. Since it lodges chiefly in
bone, it is not concentrated in passing from
animal to animal in the same ways other ra-
dioactive substances may be (unless the preda-
tor eats bones!).
Quite different is the case of the radioac-
tive isotope cesium 137. This isotope, also a
fission product, has a longlived radioactivity
(its half-life is about 30 years) and emits
penetrating gamma rays. Because it behaves
chemically like potassium, an essential con-
stituent of all cells, it becomes widely dis-
tributed once it enters the body. Consequently
it is passed along to meat-eating animals, and
under certain circumstances it can accumu-
late in a chain of carnivores.
A study in Alaska by Wayne C. Hanson,
H. E. Palmer and B. I. Griffin of the AEC's
Pacific-Northwest Laboratory showed that the
concentration factor for cesium 137 may be
two or three for one step in a food chain. The
first link of the chain in this case was lichens
growing in the Alaskan forest and tundra.
The lichens collected cesium 137 from fallout
in rain. Certain caribou in Alaska live mainly
on lichens during the winter, and caribou meat
in turn is the principal diet of Eskimos in the
same areas. The investigators found that cari-
bou had accumulated about 15 micromicro-
curies of cesium radioactivity per gram of
tissue in their bodies. The Eskimos who fed on
these caribou had a concentration twice as
high (about 30 micromicrocuries per gram of
tissue) after eating many pounds of caribou
meat in the course of a season. Wolves and
foxes that ate caribou sometimes contained
three times the concentration in the flesh of
the caribou. It is easy to see that in a longer
chain, involving not just two animals but
-------
1322
LEGAL COMPILATION—PESTICIDES
several, the concentration of a substance that
was not excreted or metabolized could be in-
creased to high levels.
A third case is that of iodine 131, another
gamma ray emitter. Again the chain to man
is short and simple: The contaminant (from
fallout) comes to man mainly through cows'
milk, and thus the chain involves only grass,
cattle, milk and man. The danger of iodine
181 lies in the fact that iodine is concentrated
in the thyroid gland. Although iodine 131 is
short-lived (its half-life is only about eight
days), its quick and localized concentration
in the thyroid can cause damage. For instance,
a research team from the Brookhaven Na-
tional Laboratory headed by Robert Conard
has discovered that children on Rongelap Atoll
who were exposed to fallout from the 1954
bomb test later developed thyroid nodules.
The investigations of the iodine 131 hazard
yielded two lessons that have an important
bearing on the problem of pesticides and other
toxic substances released in the environment.
In the first place we have had a demonstra-
tion that the hazard of the toxic substance
itself often tends to be underestimated. This
was shown to be true of the exposure of the thy-
roid to radiation. Thyroid tumors were found
in children who had been treated years before
for enlarged thymus glands with doses of
X-rays that had been considered safe. As a
result of this discovery and studies of the ef-
fects of iodine 131, the Federal Radiation
Council in 1961 issued a new guide reducing
the permissible limit of exposure to ionizing
radiation to less than a tenth of what had pre-
viously been accepted. Not the least significant
aspect of this lesson is the fact that the toxic
effects of such a hazard may not appear until
long after the exposure; on Rongelap Atoll
10 years passed before the thyroid abnormali-
ties showed up in the children who had been
exposed.
The second lesson is that, even when the
pathways are well understood, it is almost
impossible to predict just where toxic sub-
stances released into the environment will reach
dangerous levels. Even in the case of the sim-
ple pathway followed by iodine 131 the even-
tual destination of the substance and its effects
on people are complicated by a great many vari-
ables: the area of the cow's pasture (the
smaller the area, the less fallout the cow will
pick up); the amount and timing of rains on
the pasture (which on the one hand may bring
down fallout but on the other may wash it off
the forage); the extent to which the cow
is given stored, uncontaminated feed; the
amount of iodine the cow secretes in its milk;
the amount of milk in the diet of the indi-
vidual consumer, and so on.
If it is difficult to estimate the nature and
extent of the hazards from radioactive fall-
out, which have been investigated in great
detail for more than a decade by an inter-
national research program, it must be said
that we are in a poor position indeed to esti-
mate the hazards from pesticides. So far the
amount of research effort given to the eco-
logical effects of these poisons has been com-
paratively small, although it is increasing
rapidly. Much has been learned, however,
about the movement and distribution of pesti-
cides in the environment, thanks in part to
the clues supplied by the studies of radioac-
tive fallout.
Our chief tool in the pesticide inquiry is
DDT. There are many reasons for focusing
on DDT; it is long-lasting, it is now com-
paratively easy to detect, it is by far the
most widely used pesticide and it is toxic to
a broad spectrum of animals, including man.
Introduced only a quarter-century ago
[p. 29000]
and spectacularly successful during World War
II in controlling body lice and therefore
typhus, DDT quickly became a universal
weapon in agriculture and in public health
campaigns against disease-carriers. Not sur-
prisingly, by this time DDT has thoroughly
permeated our environment. It is found in
the air of cities, in wildlife all over North
America and in remote corners of the earth,
even in Adelie penguins and skua gulls (both
carnivores) in the Antarctic. It is also found
the world over in the fatty tissue of man.
It is fair to say that there are probably few
populations in the world that are not con-
taminated to some extent with DDT.
We now have a considerable amount of
evidence that DDT is spread over the earth
by wind and water in much the same patterns
as radioactive fallout. This seems to be true
in spite of the fact that DDT is not injected
high into the atmosphere by an explosion.
When DDT is sprayed in the air, some frac-
tion of it is picked up by air currents as
pollen is, circulated through the lower tropo-
sphere and deposited on the ground by rainfall.
I found in tests in Maine and New Bruns-
wick, where DDT has been sprayed from air-
planes to control the spruce budworm in forests,
that even in the open, away from trees,
about SO percent of the DDT does not fall to
the ground. Instead it is probably dispersed as
small crystals in the air. This is true even on
days when the air is still and when the low-
flying planes release the spray only 50 to 100
feet above treetop level. Other mechanisms
besides air movement can carry DDT for great
distances around the world. Migrating fish
and birds can transport it thousands of miles.
So also do oceanic currents. DDT has only a
low solubility in water (the upper limit is
about one part per billion), but as algae and
other organisms in the water absorb the sub-
stance in fats, where it is highly soluble, they
make room for more DDT to be dissolved into
the water. Accordingly water that never con-
tains more than a trace of DDT can continu-
-------
STATUTES AND LEGISLATIVE HISTORY
1323
ously transfer it from deposits on the bottom
to organisms.
DDT is an extremely stable compound that
breaks down very slowly in the environment.
Hence with repeated spraying the residues
in the soil or water basins accumulate. Work-
ing with Frederic T. Martin of the University
of Maine, I found that in a New Brunswick
forest where spraying had been discontinued
in 1958 the DDT content of the soil increased
from half a pound per acre to 1.8 pounds per
acre in the three years between 1958 and 1961.
Apparently the DDT residues were carried to
the ground very slowly on foliage and decayed
very little. The conclusion is that DDT has
a long half-life in the trees and soil of a for-
est, certainly in the range of tens of years.
Doubtless there are many places in the
world where reservoirs of DDT are accumu-
lating. With my colleagues Charles F. Wur-
ster, Jr., and Peter A. Isaacson of the State
University of New York at Stony Brook, I
recently sampled a marsh along the south
shore of Long Island that had been sprayed
with DDT for 20 years to control mosquitoes.
We found that the DDT residues in the upper
layer of mud in this marsh ranged up to 32
pounds per acrel
We learned further that plant and animal
life in the area constituted a chain that con-
centrated the DDT in spectacular fashion. At
the lowest level the plankton in the water
contained .04 part per million of DDT; min-
nows contained one part per million, and a
carnivorous scavenging bird (a ring-billed
gull) contained about 75 parts per million in
its tissues (on a whole-body, wetweight
basis). Some of the carnivorous animals in
this community had concentrated DDT by a
factor of more than 1,000 over the organisms
at the base of the ladder.
A further tenfold increase in the concen-
trations along this food web would in all
likelihood result in the death of many of the
organisms in it. It would then be impossible
to discover why they had disappeared. The
damage from DDT concentration is particu-
larly serious in the higher carnivores. The
mere fact that conspicuous mortality is not
observed is no assurance of safety. Compara-
tively low concentrations may inhibit repro-
duction and thus cause the species to fade
away.
That DDT is a serious ecological hazard
was recognized from the beginning of its use.
In 1946 Clarence Cottam and Elmer Higgins
of the U.S. Fish and Wildlife Service warned
in the Journal of Economic Entomology that
the pesticide was a potential menace to mam-
mals, birds, fishes and other wildlife and that
special care should be taken to avoid its ap-
plication to streams, lakes and coastal bays
because of the sensitivity of fishes and crabs.
Because of the wide distribution of DDT the
effects of the substance on a species of ani-
mal can be more damaging than hunting or
the elimination of a habitat (through an
operation such as dredging marshes). DDT
affects the entire species rather than a single
population and may well wipe out the species
by eliminating reproduction.
Within the past five years, with the devel-
opment of improved techniques for detecting
the presence of pesticide residues in animals
and the environment, ecologists have been
able to measure the extent of the hazards pre-
sented by DDT and other persistent general
poisons. The picture that is emerging is not
a comforting one. Pesticide residues have now
accumulated to levels that are catastrophic
for certain animal populations, particularly
carnivorous birds. Furthermore, it has been
clear for many years that because of their
shotgun effect these weapons not only attack
the pests but also destroy predators and com-
petitors that normally tend to limit prolifera-
tion of the pests. Under exposure to pesticides
the pests tend to develop new strains that are
resistant to the chemicals. The result is an
escalating chemical warfare that is self-
defeating and has secondary effects whose
costs are only beginning to be measured. One
of the costs is wildlife, notably carnivorous
and scavenging birds such as hawks and
eagles. There are others: destruction of food
webs aggravates pollution problems, particu-
larly in bodies of water that receive mineral
nutrients in sewage or in water draining from
heavily fertilized agricultural lands. The plant
populations, no longer consumed by animals,
fall to the bottom to decay anaerobically, pro-
ducing hydrogen snlfide and other noxious
gases, further degrading the environment.
Concentration
(parts per
Location Organism Tissue million)
United States Man Fat 11.0.
(Average).
Alaska (Eskimo) 2.8.
England 2.2.
West Germany 2.3.
France 5.2.
Canada 5.3.
Hungary 12.4.
Israel 19.2.
India 12.8-31.0.
United States:
California Plankton 5.3.
Do Bass Edible Flesh. 4-138.
Do Grebes Visceral Fat.. Up to 1,600.
Montana Robin Whole Body.. 6.8-13.9.
Wisconsin Crustacea 0.41.
Do Chub Whole Body.. 4.52.
Do Gull Brain 20.8.
Missouri Bald Eagle. Eggs 1.1-5.6.
Connecticut... Osprey do 6.5.
Florida Dolphin . Blubber About 220.
Canada Woodcock. WholeBody.. 1.7.
Antarctica Penguin .. Fat 0.015-0.18.
Antarctica Seal Fat 0.042-0.12.
Scotland Eagle Eggs 1.18.
New Zealand.... Trout Whole Body.. 0.6-0.8.
Note: DDT residues, which include the derivatives DDO
and DDE as well as DDT itself, have apparently entered most
food webs. These data were selected from hundreds of
reports that show DDT has a worldwide distribution, with
the highest concentrations in carnivorous birds.
-------
1324
LEGAL COMPILATION—PESTICIDES
The accumulation of persistent toxic sub-
stances In the ecological cycles of the earth
is a problem to which mankind will have to
pay increasing attention. It affects many
elements of society, not only in the necessity
for concern about the disposal of wastes but
also in the need for a revolution in pest con-
trol. We must learn to use pesticides that
have a short half-life in the environment—
better yet, to use pest-control techniques that
do not require applications of general poisons.
What has been learned about the dangers in
polluting ecological cycles is ample proof that
there is no longer safety in the vastnesa of
the earth.
DDT RESIDUES AND DECLINING REPRODUCTION
IN BERMUDA PETREL
(Abstract. Residues of DDT [1,1,1-trichloro-
2,2-bis(p-chlorophenyl) ethane] averaging 6.44
parts per million in eggs and chicks of the
carnivorous Bermuda petrel indicate wide-
spread contamination of an oceanic food chain
that is remote from applications of DDT.
Reproduction by the petrel has declined dur-
ing the last 10 years at the annual rate of
3.25 percent; if the decline continues, repro-
duction will fail completely by 1978. Concen-
trations of residues are similar to those in
certain terrestrial carnivorous birds whose
productivity is also declining. Various con-
siderations implicate contamination by in-
secticides as a probable major cause of the
decline.)
Many oceanic birds nested on Bermuda
in 1609 when the first settlers arrived, the
most abundant apparently being the Ber-
muda petrel, Pterodroma cahow. Within 20
years man and his imported mammals vir-
tually exterminated those species; for nearly
300 years it was considered extinct. Several
records of specimens since 1900 were fol-
lowed in 1951 by discovery of a small breeding
colony (1), and in 1967 22 pairs nested on a
few rocky islets off Bermuda. With a total
population of about 100 the petrel is among
the world's rarest birds.
A wholly pelagic species, P. cahow visits
land only to breed, breeds only on Bermuda,
and arrives and departs only at night. The
single egg is laid underground at the end
of a long burrow. When not in the burrow
the bird feeds far at sea, mainly on cephalo-
poda; when not breeding it probably ranges
over much of the North Atlantic (1).
Reproduction by P. cahow has declined
recently. The data since 1958 (Table 1) show
an annual rate of decline of 3.25±1.05 per-
cent; the negative slope of a weighted regres-
sion is significant (P, .015; F test). If this
linear decline continues, reproduction will fail
completely by 1978, with extinction of the spe-
cies. Many recent reports have correlated
diminished reproduction by certain carnivor-
ous birds with contamination by chlorinated
hydrocarbon insecticides (2-7). As the ter-
minal member of a pelagic food chain, pre-
sumably feeding over much of the North
Atlantic, the petrel may be expected to con-
centrate by many orders of magnitude any
stable, lipid soluble chemicals, such as chlo-
rinated hydrocarbon insecticides, present in
lower trophic levels (2, 3, 8). In fact it should
serve as an ideal environmental monitor for
detection of insecticide contamination as a
general oceanic pollutant, rather than con-
tamination resulting directly from treatment
of a specific land area (9). When we ana-
lyzed several specimens of P. cahow for chlo-
rinated hydrocarbon insecticides, all samples
contained DDT residues (10).
During March 1967 five unhatched eggs and
dead chicks were collected from unsuccessful
petrel burrows and stored frozen. The small
size of the population precluded the sampling
of living birds. Samples were analyzed for
DDT, o.p-DDT, DDE, DDD, dieldrin, and en-
drin by electron-capture gas chromatography;
the results are summarized in Table 2. No
o.p-DDT, diedrin, or
[p. 29001]
endrin was detected, but an independent labo-
ratory detected a trace of dieldrin.
Certain identifications were confirmed by
thin-layer chromatography (11) as follows:
After Florisil cleanup (12), the unknown
sample was spotted on a thin-layer plate
with l-/tg authentic standard samples on both
sides. After development, the unknown was
masked by a strip of paper, and the stand-
ards were sprayed with chromogenic reagent
(11). When spots were visible following ex-
posure to ultraviolet light, the masking was
removed, horizontal lines were drawn between
the standard spots in order to locate corre-
sponding compounds in the unknown, and
these areas were scraped from the plate and
extracted with a few drops of a mixture of
hexane and acetone (9:1 by volume). Injec-
tion into the gas chromatograph confirmed
the presence of DDT, DDE, and DDD by
showing the appropriate single peaks for these
compounds. This confirmation procedure was
employed because the electron-capture detec-
tor is more sensitive than the chromogenic
spray reagent in detecting minute amounts of
these materials.
Coincidental with diminishing reproduction
by the Bermuda petrel is the presence of DDT
residues averaging 6.44 parts per million
(ppm) in its eggs and chicks. In itself this
coincidence does not establish a causal rela-
tion, but these findings must be evaluated in
the light of other studies. Whereas a healthy
osprey (Pandion haliaetua) population pro-
duces 2.2 to 2.5 young per nest, a Maryland
colony containing- DDT residues of 3.0 ppm
in its eggs yielded 1.1 young per nest, and a
Connecticut colony containing 5.1 ppm pro-
-------
STATUTES AND LEGISLATIVE HISTORY
1325
duced only 0.6 young per nest; the Connecti-
cut population has declined 30 percent annu-
ally for the last 9 years (4). In New Bruns-
wick, breeding success of American woodcocks
(PhUohela minor) showed a statistically sig-
nificant inverse correlation with the quantity
of DDT applied to its habitat in a given year.
Furthermore, during 1962 and 1963, birds
from unsprayed Nova Scotia showed breeding
success nearly twice as great as did those from
sprayed New Brunswick, where woodcock eggs
averaged 1.3 ppm of DDT residues during
those years (6).
TABLE 1.—REPRODUCTIVE SUCCESS OF THE BERMUDA
PETREL BETWEEN 1958 AND 1967'
Success
Year Pairs Chicks (percent)
1958.
1959.
1960.
1961.
1962.
1963.
1964.
1965.
1966.
1967.
17(1)
17(1)
4
2
6
12
9
9
20
21
22
66.7
40.0
46.2
66.7
47.4
529
47.1
40.0
28.6
36.4
1 Percentages of established adult pairs under observation
whose chicks survived 2 weeks after hatching. Numbers of
pairs of unknown success (not included in calculations)
appear in parentheses. Data from 1961 to 1967 are believed
to represent the total breeding population; earlier, not all
burrows had been discovered. The decline in reproductive
success follows the linear relation y=a+bx(y, reproductive
success; a, a constant; b, annual percentage decline in
success; x, year). The regression weighted by numbers of
pairs: y=251.9—3.25x.
In Britain five species of raptors, includ-
ing the peregrine falcon (Falco peregrinus)
and golden eagle (Aquila ehrysaetoi), carried
residues of chlorinated hydrocarbon insecti-
cides in their eggs, averaging 6.2 ppm; each
of these species has shown a decline in repro-
duction and total population during recent
years. By comparison, residues in the eggs of
five species of corvids averaged 0.9 ppm, and
breeding success and numbers have been main-
tained (6). It is noteworthy that during the
last decade the peregrine has become extinct
as a breeding bird in the eastern United
States (IS). Residues in bald eagle (HaUaetus
leucocephalus) eggs averaged 10.6 ppm, and
this species also shows declining reproduction
and population
-------
1326
LEGAL COMPILATION—PESTICIDES
hawk, Accipiter nisus (20). This decrease
correlates with the widespread introduction
of DDT into the environment during those
years, and further correlates with the onset
of reduced reproduction and of the described
symptoms of calcium deficiency. These mul-
tiple correlations indicate a high probability
that the decline in reproduction in most or
all of these birds, including P. cahow, is
causally related to their contamination by
DDT residues.
Other potential causes of the observed de-
cline for the Bermuda petrel appear unlikely.
The bird has been strictly protected and iso-
lated since 1957, and it seems that human
disturbance can be discounted. In such a
small population, inbreeding could become
important, but hatching failure is now con-
sistent in pairs having earlier records of suc-
cessful breeding, and deformed chicks are
never observed. Furthermore, the effects of
inbreeding would not be expected to increase
at a time when the total population, and prob-
ably the gene pool, is still increasing. The
population increase results from artificial
protection since 1957 from other limiting fac-
tors, especially competition for nest sites with
tropic birds (HI).
It is very unlikely that the observed DDT
residues in P. cdhow were accumulated from
Bermuda; the breeding grounds are confined
to a few tiny, isolated, and uninhabited islets
never treated with DDT, and the bird's feed-
ing habits are wholly pelagic. Thus the pres-
ence of DDT residues in all samples can lead
only to the conclusion that this oceanic food
chain, presumably including the plankton, is
contaminated. This conclusion is supported
by reported analyses showing residues in re-
lated seabirds including two species of shear-
waters from the Pacific (22); seabird eggs
(9, 22); freshwater, estuarine, and coastal
plankton (2, S, US); plankton-feeding orga-
nisms (2, S, 9. 22, 2S); and other marine ani-
mals from various parts of the world (S, 22).
These toxic chemicals are apparently very
widespread within oceanic organisms (S, 22),
and the evidence suggests that their ecologi-
cal effects are important.
CHARLES F. WUBSTEB, JK.,
Department of Biological Sciences.
State University of New York,
Stony Brook
DAVID B. WINGATB,
Department of Agriculture and
Fisheries, Paget East, Bermuda.
REFERENCES AND NOTES
1. R. C. Rurphy and L. S. Mowbray, Auk
68, 266 (1961); A. C. Bent, IAS. Nat. Museum
Butt. Itl (1922), pp. 112-7.
2. Ł. 6. Hunt and A. L Biscboff, Calif.
Fish Game 46, 91 (1960); E. G. Hunt, in Nat.
Acad. Sei.-Nat. Res. Council PubL 1401
(1966), p. 261.
3. J. P. Ludwig and C. S. Tomoff, Jack-
Pine Warbler 44. 77 (1966); J. A. Keith, J.
Appl. Eeol. 3 (suppL), 67 (1966); J. J. Hic-
key, J. A. Keith, F. B. Coon, ibid., p. 141.
4. P. L. Ames. ibid., p. 87.
5. B. S. Wright, J. Wildlife Management 29,
172 (1966).
6. S. Cramp, Brit. Birds 66, 124 (1963); J.
D. Lockie and D. A. Ratcliffe, ibid. 57, 89
(1964); D. A. Ratcliffe, ibid. 68, 66 (1966);
Bird Study 10, 66 (1963); 12, 66 (1965).
7. L. F. Stickel et al., in Trans. North
American Wildlife Natural Resources Con/.
Slat (1966), pp. 190-200; J. B. DeWitt, Audit-
ion Mao. 65, 30 (1963); A. Sprunt, ibid., p.
32.
8. G. M. Woodwell, C. F. Wurster, P. A.
Isaacson, Science 156, 821 (1967); G. M.
Woodwell, Set. Amer. 216, 24 (March 1967).
9. N. W. Moore and J. O'G. Tatton, Nature
207, 42 (1965); N. W. Moore. J. AppL Ecol.
3 (suppl.), 261 (1966).
10. Residues of DDT include DDT and its
decay products (metabolites) DDE and DDD;
DDT, 1,1,1 - trichloro- 2,2 -bis (p-chlorophenyl) -
ethane; DDE, l,l-dichloro-2,2-bis(p-chloro-
phenyl) ethylene; DDD (also known as TDE),
l,l-dicnloro-2,2-bis(j>-chlorophenyl) ethane.
11. M. F. Kovacs, J. Assoc. Offic. Anal,
Chemists 49, 366 (1966).
12. J. G. Cummings, K. T. Zee, V. Turner,
F. Quinn, R. E. Cook, ibid., p. 354.
13. R. A. Herbert and K. G. S. Herbert, Auk
82, 62 (1966); J. J. Hickey, Ed., Peregrine
[p. 29002]
Falcon Populations, Their Biology and De-
cline (Univ. of Wisconsin Press, Madison, in
press).
14. J. B. DeWitt, J. Agr. Food Chem. 3, 672
(1965); 4, 863 (1966); R. E. Genelly and R. L.
Rudd. Auk 73, 629 (1966).
16. J. H. Koeman, R. C. H. M. Oudejans,
and E. A. Huisman, Nature 215, 1094 (1967).
16. D. J. Jefferies, Ibis 109, 266 (1967); H.
Burlington and V. F. Lindeman, Proc. Soc.
Exp. Biol. Med. 74, 48 (1960); D. B. Peakall,
Nature 216, 505 (1967); Atlantic Naturalist
22, 109 (1967).
17. J. H. Welsh and H. T. Gordon, J. Cett.
Comp. Physiol. 30, 147 (1947); H. T. Gordon
and J. H. Welsh, ibid. 31, 395 (1948).
18. Z. Vaz, R. S. Pereira, D. M. Malheiro,
Science 101, 434 (1945).
19. D. H. Wurster, C. F. Wurster. R. N.
Strickland, Ecology 46, 488 (1965); L. B.
Hunt, unpublished manuscript. University of
Wisconsin, 1966.
20. D. R. Ratcliffe, Nature 215, 208 (1967).
21. D. B. Wingate, Can. Audubon 22, 145
(1960).
22. R. W. Risebrough, D. B. Menzel, D. J.
Martin, H. S. Olcott, Nature 216, 589 (1967);
J. Robinson, A. Richardson, A. N. Crabtree,
J. C. Coulson, G. R. Potts, ibid. 214, 1807
(1967); W. J. L. Sladen, C. M. Menzie, W. L.
-------
STATUTES AND LEGISLATIVE HISTORY
1327
Eeichel. ibid. 210, 670 (1966); J. O. G. Tatton
and J. H. A. Euzicka, ibid. 216, 346 (1967);
J. O. Keith and E. G. Hunt, in Trans North
American Wildlife Natural Resources Conj.
Slit (1966), pp. 150-77.
23. P. A. Butler, ibid!., pp. 184-9; J. Appl.
Ecol. 3 (suppl.), 253 (1966).
24. Aided by a grant from the Eesearch
Foundation of the State University of New
York; transportation by the Smithsonian In-
stitution, Washington, D.C. The Bermuda
petrel conservation program was financed by
Childs Frick and the New York Zoological
Society. We thank G. M. Woodwell for crit-
icizing the manuscript.
THE PEREGRINE SITUATION IN GREAT BRITAIN
1965-66
(By D. A. Ratcliffe)
(Monks Wood Experimental Station—The
Nature Conservancy)
INTRODUCTION
In order to follow latest trends in the
breeding population of the British Peregrine
(Falco peregrinus), a sample census was con-
tinued in 1965 and 1966 on a scale similar to
that of 1963-64. This paper summarises the
results, and gives data on chemical analysis
of the small samples of eggs taken during
these two years.
CENSUS DATA
Observations on 200 territories in 1965
and 213 territories in 1966 (representing 240
different territories of the two-year period)
are given in Table I, according to the six
different regions of Great Britain recognised
previously (Ratcliffe 1963). This sample is
approximately one-third of the mean annual
total of 650 territories estimated to be occu-
pied regularly in Great Britain during the
standard period 1930-39, or just under one-
third of the total of 718 territories occupied
at least once since 1930. Census data for
1961-64 are given for comparison. However,
because of a bias against visiting previously
deserted territories and reporting negative
observations during the period 1963-66, the
figures for these years are not directly com-
parable with those for 1961-62, and a correc-
tion has to be made (see Table I).
It is evident that there has been no ap-
preciable change in level of breeding popula-
tion since 1964, for although only 14 success-
TABLE I.—OCCUPATION OF PEREGRINE TERRITORIES, 1963-66
tl
Vear and region
1961: Total for Great Britain
1962: Total for Great Britain.
1963: Total for Great Britain
1964: Total for Great Britain
1965:
Southern England
Wales
Northern England
South and East Highlands...
North and West Highlands...
Total for Great Britain
1966:
Southern England
Wales
Northern England
Southern Scotland
South and East Highlands. . .
North and West Highlands...
Number
of tern- B
Dries ex-
amined
431
488
200
203
42
34
30
31
47
36
220
42
40
24
32
44
31
lirds ap-
parently
absent
173
247
110
109
40
26
17
12
18
117
40
34
13
11
7
12
lor
both of
the pair
present
but not
proved
to nest i
118
119
34
28
6
2 ..
3
8
6
25
3
4
6
11
5
Nesting,
outcome
mknown
17
22
4
3
1
3
7
6
17
1
2
1
7
Nested,
but un-
success-
fully
(eggs or
young
lost)
41
35
13
15
4
5
4
3
16
3
4
2
5
Successful
nesting
(young
reared)
91 (9)
77 (9)
39 (0)
48(0)
1
2
7
g
24
3
45(1)
2
2
3
9
23
2
Total for Great Britain
213
117
29
12
14
41 (3)
Notes: To make approximate correction for comparison with 1961-62, the figures for 1963-66regarding"birds apparently
absent* should be increased by ^j, and those for "successful nesting" should be reduced by K.These factors are derived
as follows: The sample of eyries visited in each of the years 1963-66 is similarly biased (toward territories likely to give
positive rather than negative records) by comparison with the much larger sample for 1961-62, and many eyries visited
with negative results have evidently not been reported to me. If the 1962 data are subsampled to give a list of those
eyries which were actually visited during 1963-66, simple calculation gives values of 44 percent for territory desertion
and 24 percent fpr successful breeding pairs. The figures calculated from the full 1962 data are, however, 50 and 16
percent respectively, i.e. approximately }f more for territory desertion and H less for successful pairs. As the samples
for 1961 and 1962 were closely comparable, the above correction factors apply also to 1961.
Actual breeding success for 1961 and 1962 is 19 and 13 percent, respectively, when broods taken by falconers are
regarded as failures (as in Ratcliffe 1963), but to show more accurately the proportion of healthy broods potentially able
to fledge, those taken by falconers have been included and give breeding success as a theoretical 21 and 16 percent.
Broods taken by falconers (illegally after 1961) are bracketed alongside the totals.
-------
1328
LEGAL COMPILATION—PESTICIDES
ful eyries were known In 1966, against 45 in
1966. this is not a significant difference. The
data certainly give no hint of overall im-
provement in the Peregrine situation during
the last two years. Few records for the main-
land of the North and West Highlands are
available for 1965-66, and most of the data
referring to this region are for Orkney and
Shetland. It is clear that parts of the South
and East Highlands are still the stronghold
of the Peregrine in Britain, and breeding suc-
cess has remained good in this region; but
even here, a quarter of the inspected terri-
tories held apparently nonbreeding birds in
1966. In England and Wales together, suc-
cessful breeding was limited to ten pairs in
1965 and seven pairs in 1966, and at least
four-fifths of the territories visited were un-
occupied in both years.
When the figures for 1966-66 are compared
with those for 1963-64, the proportion of
deserted territories is seen to have been fairly
constant throughout, i.e. about 60 percent of
the number of known territories visited,
when correction for observation/recording
bias has been made. Regarding breeding suc-
cess, it should be noted that in 1965 and
1966 there were, respectively, 17 and 12 eyries
where eggs were probably or certainly laid,
but which were not re-visited to determine
the final outcome; whereas in 1963 and 1964
there were only 4 and 3 such eyries. As the
other data suggest that at least half the 'out-
come unknown' eyries would be successful,
the figures for successful nesting in the
1965-66 census samples would almost cer-
tainly be higher than those given in Table I.
Even so, it is doubtful if there is valid evi-
dence for a significant change in breeding
success during the whole four-year period
1963-66; this has fluctuated from about 13
to 16 per cent of the number of known ter-
ritories visited. There may have been a slight
recovery in 1964 after the low ebb of 1963,
but the figures may indicate merely the nor-
mal fluctuation of a population which has
become relatively stabilised at a much re-
duced level; while, in any case, there is likely
to be a degree of sampling and observational
error.
By comparison with the fuller data for
1961-62, it would seem that the rapid decline
of those years continued into 1963, but that
the population then leveled off, and, at most,
has since shown marginal improvement in
breeding success alone. On the other hand,
when data for each region are examined sepa-
rately, the population of Southern Scotland
has shown evident improvement in breeding
success since 1963; in 1963, only 3 out of 19
inland territories visited had successful pairs,
whereas in 1966, 8 out of 24 reared young. M.
Gilbertson (pers. comm.) also reports an ap-
parent improvement in Northern Ireland,
where a total of only 5 young was reared in
14 territories examined in 1964, compared
with a total of 11 young in 16 territories in
1966. These are the regions closest to the
Scottish Highlands, and therefore the onea in
which any recovery of the Peregrine popula-
tion might be expected to show first.
PESTICIDE RESIDUES
Although only 12 Peregrine eggs have been
analysed (by gas-liquid chromatography) for
organo-chlorine pesticide residues in 1965-66,
the results (Table II) are revealing. Despite
the higher levels, compared with 1963-64, the
sample is too small for the data to be re-
garded as valid evidence of an increase in
contamination. However, the figures suggest
that the voluntary restrictions on use of al-
drin, dieldrin and heptachlor, in 1964, have
(up to the spring of 1966) had no effect in
reducing the contamination of the British
Peregrine by residues of these pesticides.
The figures for heptachlor in particular indi-
cate that, despite statements to the contrary,
[p. 29003]
there was still a considerable local use of
this chemical during 1965-66.
Whilst only 5 egg analyses are available yet
for the central part of the South and East
Highlands, they show an appreciably lower
mean level of contamination than the 22 eggs
from Northern England and Southern Scot-
land, though the difference lies largely in the
DDE component of the residues. This matches
the differences between the first region and
the second two in regard to both state of the
population and breeding success; and it sup-
ports the earlier contention (Ratcliffe 1963,
1965) that contamination risk to the Pere-
grine is lower in the South and East High-
lands than in most other parts of the British
Isles. Even within the 5 Highland eggs there
are suggestive differences; the two from An-
gus (within Peregrine reach of rich arable
farm land) contain appreciably higher resi-
dues of DDE, dieldrin and heptachlor expox-
ide than those from the three Inverness-shire
eyries, which were all remote from agricul-
tural land.
The egg analyses for 1963-64 showed no
difference between those from eyries which
failed and those which produced flying young
from the remaining eggs (Ratcliffe 1966).
Now that more data are available, a slight
difference shows when all egg analyses are
thus separated; the figures are (total organo-
chlorine residues) 17.4 p.p.m. for eggs from
failed eyries and 12.7 p.p.m. for eggs from
successful eyries. The difference is not sta-
tistically significant but it is suggestive.
In 1966, two eggs were examined for resi-
dues of mercury; one was blank (Table IIB,
1966/1) but the other (Table IIB, 1966/3)
contained 0.3 p.p.m.
-------
STATUTES AND LEGISLATIVE HISTORY
1329
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-------
1330
LEGAL COMPILATION—PESTICIDES
BREEDING SUCCESS, BROOD SIZE AND REPLACEMENT
OF LOSSES
Of the 30 eyries which fatted in 1966-66, egg
breakage or disappearance of eggs (usually
one by one and apparently due to parental
destruction) was the cause of failure in 26.
Mean brood size in successful eyries has con-
tinued to be low in regions south of the High-
lands (average of 1.8 young for 24 known
broods) and normal in the South and East
Highlands (average of 2.5 young for 28 known
broods).
I have recently been provided with data
collected by the late W. C. Lawrie at a regular
Lakeland eyrie between 1910 and 1939. The
history is incomplete, but the following records
are available of all successful nestings in which
the brood-size was definitely known:
1913, 3 young 1927, 4 young
1914, 3 young 1928, 1 young
1920, 3 young 1930, 4 young
1922, 3 young 1931, 3 young
1924, 4 young 1936, 4 young
1925, 2 young 1939, 4 young
1926, 4 young
The mean of these 13 broods was 3.2 young,
an appreciably higher figure than the national
pre-war average of 2.5 young. Unspecified
broods were also reared in several other years
and there are in existence several clutches of
eggs taken from this locality during the same
period. The haunt was never known to be
deserted between 1910 and 1939, and the only
cause of breeding failure was egg collecting,
apart from one year in which the birds de-
serted after being kept off the nest for many
hours. At least two different females were in-
volved during this period.
The recent history of occupation at this
same haunt is as follows:—
1961 3 eggs; two were later broken, the third
hatched but the chick died.
1962 3 eggs; all disappeared later, evidently
through parental destruction.
1963 3 eggs; one taken fresh for chemical
analysis (Table IIB, 1963, No. 3), the other
two hatched; one chick died and the other
fledged.
1964 3 eggs; only one chick hatched and it
later died.
1965 3 eggs; one broken later, one bad (Table
IIB, 1965, No. 4) and the third hatched; the
single chick fledged.
1966 No trace of the birds.
While the two eggs containing total organo-
chlorine residues of 86 and 27 p.p.m. (dieldrin+
heptachlor epoxide 5.2 and 1.4 p.p.m.) were
from clutches from which single young were
fledged, this level of contamination was asso-
ciated with a marked reduction in brood size,
compared with pre-war years. This haunt was
one of only five (out of 30) once regularly
occupied territories in Northern England which
were continuously occupied throughout the
period 1960-65; and 1966 was the first year
since 1910 when Peregrines were absent. Prob-
ably the same female occupied the haunt from
1961 to 1966, but it was a different bird from
that present in 1939.
The summarised figures in Table I conceal
the details of change occurring within a popu-
lation which as a whole remains stable. For
instance, in Southern Scotland, 27 territories
were visited in both 1965 and 1966, and 16
were found occupied in each year, but only 13
were occupied in both years. Since 1960, it is
usual for this region and Northern England
to show small gains and losses in any year, by
comparison with the preceding and succeeding
years, so that fresh gaps are still appearing as
old ones are filled.
The output of young Peregrines annually
from the whole of the Scottish Highlands would
seem adequate to allow a slow receovery, at
least in occupation of territories, and it is
perhaps surprising that even in this region,
about 47 per cent of territories visited re-
mained deserted or held by non-breeders in
1966. However, the annual surplus has also to
fill gaps caused by mortality amongst the es-
tablished breeding population, and when birds
move away from their birthplace to depleted
areas, they are themselves increasingly exposed
to pesticidal contamination, with the implica-
tion of increased risks of mortality and breed-
ing failure. As not all Peregrines are likely to
reach sexual maturity at one year old, many
probably pass their juvenile stage in country
away from breeding haunts and may then be
more at risk, as regards pesticides, than if they
were able to occupy a nesting place in their
first year.
Walpole-Bond (1914) noted that a barren
female Peregrine refused to mate or to allow
a prospecting pair to settle on her breeding
cliffs, but after she was shot, a new pair
soon appeared and nested. It could be that
many of the non-breeding Peregrines recently
holding territories also defend them against
potential breeders which arrive from other
area. Cade (1960) has suggested that the
tenacity with which Peregrine eyries are
[p. 29004]
usually held over a long period depends on the
survival at all times of one bird of the occupy-
ing pair, and that when both of the pair die
simultaneously, continuity is lost and the haunt
may then be left deserted for a period. Many
Peregrine breeding haunts south of the High-
lands seem to have been totally deserted for
several years, and this loss of continuity may
be an additional factor working against their
re-occupation. Even BO, rate of re-occupation of
totally deserted haunts in Southern England
was fairly rapid after intensive human 'control'
ceased in 1945. The continued failure of the
Peregrine to restore its previous breeding
numbers is most likely to be explained by lack
-------
STATUTES AND LEGISLATIVE HISTORY
1331
of improvement in the adverse factor which
originally depleted the areas concerned.
CONCLUSIONS
The continued investigations of 1966-66 rein-
force earlier conclusions (Ratcliffe 1963, 1965)
that the persistent organo-chlorine pesticide
residues have been a causal factor in the post-
1955 decline of the Peregrine in Britain. In
view of the evident maintenance of contamina-
tion levels in the environment, it is not sur-
prising that the breeding population has shown
no clear tendency towards recovery. Moreover,
there would seem to be no sign of general re-
sistance to these chemicals developing in this
species.
SUMMARY
A sample census of about one-third of the
Peregrine breeding population of Great Brit-
ain in 1965 and 1966 indicates that there
has been no significant change in proportion
of occupied territories or breeding success
of remaining birds during this period.
Comparison with earlier data suggests that
the Peregrine decline ceased after 1963, and
that the population has since remained rela-
tively stable, with occupied territories at
about 40 per cent of the pre-war level and
breeding success (pairs rearing young) vary-
ing between about 13 and 16 percent of the
maximum possible level (former mean an-
nual number of pairs). Breeding success may
have improved marginally after 1963 on the
national scale, and more significantly in
Southern Scotland and Northern Ireland.
The geographical pattern is unchanged,
with population level, breeding success and
brood size lowest in England and Wales, and
highest in the South and East Highlands of
Scotland.
Analysis of Peregrine eggs gives no evi-
dence of a decrease in contamination by any
organo-chlorine residue since 1964. Eggs from
Northern England and Southern Scotland
were more heavily contaminated than those
from the South and East Highlands during
the period 1968-66, though the difference lies
mainly in the DDE component.
Failure of young Peregrines from success-
ful eyries to build up the breeding population
of depleted areas is probably a reflection pri-
marily on the lack of improvement in the
adverse factor which initiated decline.
ADDENDUM
Since this account was written, preliminary
data for 1967 have become available. They in-
dicate a slight recovery of population, in both
occupation of territories and breeding success,
in the east and centra] Scottish Highlands,
Northern England and Northern Ireland. In
the southwest Highlands and Southern Scot-
land, breeding success was lower than in 1966,
but there was no decrease in number of
occupied territories. Analysis of ten eggs in
1967 shows a decrease in organo-chlorine resi-
due levels, especially of dieldrin and hepta-
chlor epoxide, compared with 1956-66, and
also confirms that residue levels are signifi-
cantly lower in the Central Highlands than
in other regions of the south. Slight recovery
of the population in more northerly regions
is thus consistent with a decrease in environ-
mental contamination, at least in these more
marginal arable farming districts, which
were least affected by the original population
decline.
It has recently been shown (Ratcliffe 1967)
that the post-war prevalence of egg breaking
in the British Peregrine correlates closely
with a widespread decrease in eggshell
weight/size ratio (i.e. probably thickness)
which appeared in 1947 and has persisted
ever since, except in some parts of the
Central Highlands. The connections between
these phenomena, and their possible relation-
ships to contamination of the species by
organo-chlorine residue, are being examined.
PROBLEMS WITH DDT IN FISH CULTURAL
OPERATIONS
(J. P. Cuerrier, J. A. Keith, and E. Stone)
ABSTRACT
'Various concentrations of DDT and residues
have been detected in eggs and fry of speckled,
rainbow, and cutthroat trout obtained from
local sources and from commercial suppliers
and handled at the Maligne Eiver Trout Hatch-
ery, Jasper National Park, Alberta. Concen-
trations of DDT and metabolites exceeding 400
ppb in eggs resulted in a 30 to 90 per cent
mortality among the fry 60 fingerlings during
the days following the swim-up stage. All com-
mercial dry feeds analysed contained DDT.
Among ingredients used in the manufacturing
of trout feeds, only brewer yeast was found
almost free of contamination.
INTRODUCTION
Because of the very wide distribution of DDT,
it would seem that all forms of life are being
exposed, directly or indirectly, to this chemical
insecticide. Extensive research has been done
on the toxicity of DDT to insects, the primary
target, but comparatively little is known of
the effects of secondary contamination of ani-
mals, particularly during the very early stages
of development. The purpose of this paper is
to present data on DDT contamination of trout
in fish hatcheries.
Mack and co-workers (1964) found DDT
concentrations in whole fish ranging from 0.2
to 7 ppm; certain tissues or organs contained
up to 40 ppm. Burdick and co-workers (1964)
found as much as 500 ppm of DDT by weight
in ether-extracted oils from lake trout eggs
taken from Lake George, New York State.
They found that 90 percent of lake trout <—••»
-------
1332
LEGAL COMPILATION—PESTICIDES
containing 2.95 ppm of DDT and above died
at the fry stage. With landlocked salmon at
Sebago Lake, Maine, Anderson and Everhart
(1966) found that ovaries of three-year-old
salmon contained 0.87 ppm of DDT, while
ovaries of older salmon showed 6.0 ppm of
DDT.
Mortality at the yolk-sac stage of lake trout
in George Lake and other waters in the State
of New York, and of the landlocked salmon in
Sebago Lake, has been ascribed to DDT con-
tamination.
For many years, gill diseases were thought to
cause mortality at different stages of develop-
ment of the various trout species raised at the
Maligne River Trout Hatchery, Jasper Nation-
al Park, Alberta. Recent investigations by the
Pathology Section of the Canadian Wildlife Serv-
ice, with the co-operation of the U.S. Bureau
of Sport Fisheries and Wildlife, have revealed
the occurrence of such diseases as "cold-water
disease", infectious pancreatic necrosis, and
"kidney disease", in addition to gill diseases.
Mortality has also been caused by dissolved
copper and zinc from pipes and valves in the
hatchery. In spite of these hazards and the
Damocles' sword ever present in fish culture
operations, in 1966 the Maligne River Hatchery
produced more than one and one-half million
trout of various species and sizes for plantings
in the Mountain Park waters.
However, some mortality could not be ex-
plained by viral or bacterial infections and
DDT contamination was suspected. Samples of
eggs, alevins, and commercial dry feeds were
analysed. All analyses were performed under
contract by Dr. D. J. Ecobichon, Pharmacology
Division, University of Guelph, using electron
capture gas chromatography and the extraction
procedure of Saschenbrecker and Ecobichon
(1967).
TROUT EGGS AND ALEVINS
Trout eggs handled at the Maligne River
Trout Hatchery come from various sources:
(a) local collections from wild stocks originat-
ing from annual hatchery plantings; (b) local
collections from domestic stocks held at the
hatchery; (c) commercial suppliers located in
the United States; and (d) provincial and
federal fisheries agencies. Table 1 presents data
on DDT and metabolite levels found in eggs
and alevins of various species of trout.
In view of the preliminary and exploratory
nature of this report, no attempt is being
made to establish a relationship between the
levels of each type of residue found in the
various samples. However, in samples with
levels of total DDT and residues below 200
ppb, residues of DDT and metabolites appear
in the following order: the lowest levels are
of o.p'-DDT, followed by ODD,, p-p'-DDT, and
DDE. DDE was the major component, with
about twice as much of it as of the other
residues combined.
TABLE 1.—DDT AND METABOLITES IN PARTS PER 10* (PPB) WET WEIGHT IN EGGS AND FRY OF VARIOUS SPECIES
OF TROUT
Sample
catalog
B-477
B-479
B-480
B-726
B-727
B-728
B-729
B-730
B-420
B-417
B-418
B-478
Concentration in parts per 10', ppb, wet weight
Description >
RT eggs, wild, Jasper
RT eggs commercial
RT eggs, commercial _
RT eggs, commercial _
RT eggs commercial
RT eggs, commercial _
Cutth. T. eggs, domestic
. RTf.sp., yolkfry
. RTf.sp., yolk fry..
EBT fry, domestic
DDE
65
57
63
79
129
46
62
166
333
1,022
971
217
o,p'-DDT
8
19
29
(')
1
54
^
ODD
23
28
33
9
n
6
378
A
178
51
p,p'-DDT
25
44
53
9
i
87
52
&
Total
123
US'1
178
79
176
64
68,
567
464
1,422
1,149
485
- Losses*
(percent)
—15
\-
30
70
90
90
90
1 Abbreviations: RT equals rainbow trout; f.sp. equals fall spawning; EBT equals eastern brook or speckled trout;
Cutth T. equals cutthroat trout.
1 Losses during the 2-month period following the swim-up stage.
1 Indicates undetected, the limit of detection being 1 ppb.
* Indicates traces in the range of 1 to 5 ppb.
Eggs collected from wild rainbow trout in
Lake Edith, Jasper National Park, where an-
nual plantings are carried out, showed a total
level of 123 ppb of DDT and metabolites.
Losses during the 60 days following the swim-
up stage were less than 16 per cent Spring-
spawning rainbow trout eggs from commercial
sources contained levels ranging from 64 ppb
to 178 ppb. Losses in alevins from these eggs
were less than 15 per cent during the 60 days
following the swim-up stage. Losses of this
magnitude are considered normal for that stage.
However, cutthroat trout fry resulting from
eggs purchased from a commercial supplier
showed a total concentration of 667 ppb of
DDT and metabolites; losses were about 80
percent.
Eastern brook trout fry resulting from eggs
[p. 29005]
-------
STATUTES AND LEGISLATIVE HISTORY
1333
extracted from a domestic brood stock held
at the Jasper Hatchery had a mortality of TO
per cent. The total level of DDT and metabo-
lites was 464 ppb.
Rainbow trout yolk-sac fry from an au-
tumn-spawning strain obtained from a com-
mercial supplier contained 396 ppb of DDT
and 236 ppd of DDD for a total of 1,285 ppb
of DDT and metabolites. Losses amounted to
close to 90 per cent in the two-month period
which followed the swim-up stage. Similar
heavy losses were experienced with brook
trout fry resulting from eggs obtained from a
domestic brood stock held by a government
agency. The concentration of total DDT and
metabolites was 485 ppb, mostly DDE and
p.p'DDT.
The fish with high levels of mortality were
not exposed to disease more than the others,
but during the period of this study, mortality
above 25 per cent seemed to be associated
with comparatively high levels of DDT and
its metabolites. Therefore, we conclude that
insecticide residues were responsible for this
high mortality. In their paper on chronic ef-
fects of DDT on cutthroat trout, Allison and
coworkers (1964) stated that "there was a
critical period shortly after hatching when
mortality was noticeably higher in offspring
of the high-dosage lots".
The relationship between mortality, level
of DDT contamination of the eggs, and tem-
perature of the water during yolk-sac ab-
sorption is under experimental study. In-
cubation and hatching during the winter
and spring seasons at the Maligne River Trout
Hatchery take place at a water temperature
of 40° F. Brook trout fry and alevins which
experienced a 90 per cent mortality at our
Maligne River Trout Hatchery had less than
15 per cent mortality at the hatchery where
the eggs came from. At that establishment,
incubation of trout eggs is carried out at a
water temperature ranging from 32° F. to
36° F.
COMMERCIAL TROUT DRY FEEDS
Fry are fed with commercial dry feeds after
reaching the advanced swimup stage. Sam-
ples of dry feeds were analyzed. Results are
presented in Table 2 but for obvious reasons,
brand names and sources are not given.
Analyses revealed the presence of DDT in all
samples, with levels ranging from 2 ppb to
234 ppb. One sample also contained 17 ppb of
dieldrin.
Presence of metabolites, from low to high
levels, is as follows: o.p'-DDT, DDD, p,p'-
DDT, and DDE. This same order was ob-
served with the samples of rainbow trout
eggs with low levels of DDT and metabolites.
Some ingredients utilized in the manufac-
turing of dry feeds were analyzed for DDT
residues. Data obtained indicated that of
all the ingredients examined, only brewers'
TABLE 2.—DDT AND METABOLITES IN PARTS PER 10'
-------
1334
LEGAL COMPILATION—PESTICIDES
CHLORINATED HYDROCARBONS AND EGGSHELL
CHANGES IN RAPTORIAL AND FISH-EATINO
BIRDS
(Abstract. Catastrophic declines of three
raptorial species in the United States have
been accompanied by decreases in eggshell
thickness that began in 1947, have amounted
to 19 percent or more, and were identical to
phenomena reported in Britain. In 1967,
shell thickness in herring gull eggs from
five states decreased with increases in chlori-
nated hydrocarbon residues.)
New perspectives on the role of chlorinated
hydrocarbon insecticides in our environment
have come into focus in recent years. Suc-
cessive discoveries have demonstrated that
these compounds are systematically con-
centrated in the upper trophic layers of
animal pyramids (1). Raptorial bird popu-
lations have simultaneously suffered severe
population crashes in the United States and
Western Europe (2, 3, 4). These involve
reproductive failures which, at least in Brit-
ain, are characterized by changes in calcium
metabolism and by a decrease in eggshell
thickness resulting in the parent birds'
breaking and eating their own eggs (4, 5.
6). Such a derangement of calcium metab-
olism or mobilization perhaps could result
from breakdown of steroids by hepatic mi-
crosomal enzymes induced by exposure to low
dietary levels of chlorinated hydrocarbons (7).
We have examined the possibility that the
eggshell changes reported in Britain (6) have
also occurred in the United States and that
the raptor population crashes in Europe and
North America may have had a common
physiological mechanism. The population
changes are without parallel in the recent
history of bird populations (8). They in-
clude the pending extirpation of the peregrine
falcon (Falco peregrinus) in northwestern
Europe, the complete extirpation of the nest-
ing population of this species in the eastern
half of the United States, and simultaneous
declines among other bird- and fish-eating rap-
tors on both sides of the Atlantic.
We examined 1729 blown eggs in 39 mu-
seum and private collections. Shells were
weighed to the nearest hundredth of a gram.
In 29 percent of these, we were able to insert
a micrometer through the hole drilled by the
collector at the girth of the shell and to take
four measurements of thickness 7 mm from
the edge of the blow hole; these were then
averaged to the nearest 0.01 mm for each
shell. Thickness in each case then repre-
sented the shell itself plus the dried egg
membranes. Peregrine falcons, bald eagles
(Haliaeetus leucoeephalut). and ospreys (Pan-
dion haliaetus) were selected as having one or
more regionally declining populations; golden
eagles (Aquila chrysaeetOi), red-tailed hawks
(Buteo jamaieenrif), and great horned owls
(Bubo viroinianus) were selected as represen-
tative of reasonably stationary populations
that may be slowly declining as their habitats
are gradually destroyed by man, but for which
widespread reproductive failures are currently
unknown. In addition, 57 eggs of the herring
gull (Lana arnentatusi were collected from
five colonies in 1967. The shells of these were
dried at room temperature for 4 months be-
fore being measured, and residues of the en-
tire egg contents were analyzed by the Wis-
consin Alumni Research Foundation for
chlorinated hydrocarbons but not for poly-
chlorinated biphenyls. Analytical procedure
followed that outlined by the U.S. Food and
Drug Administration ($). Analyses were con-
ducted on a gas chromatograph (Barber
Coleman, model GC 5000, and Jarrell-Ash,
model 28-700) with electron-capture detec-
tors. The glass column (0.6 cm by 1.2 m)
was packed with 5 percent DC 200 (12,500)
on Cromport XXX. The column temperature
was 210°C, and the nitrogen flow rate was
75 cm'/min. Each portion of the ground and
dried samples was extracted for 8 hours or
more in a Soxhlet apparatus with a mixture
of ether and petroleum ether (70:170). Por-
tions of the extracts were further purified by
putting them through a Florisil column.
In California, where the peregrine falcon
population is in "a serious condition" (10),
a change of 18.8 percent in shell weight oc-
curred from 1947 to 1952. Ratclifle (6) found
a corresponding decrease of 18.9 percent in
Britain. The change in California involved
a decrease in shell thickness and had no
precedent in the previous 57-year recorded
history of the peregrine in that state (Fig. 1).
In the eastern United States, where the nesting
population of peregrines has now been wiped
out (8), fragmentary data indicate that the
same change took place (Table 1). Broken
eggshells in a North American peregrine eyrie
were observed for the first time in 1947 by
J. A. Hagar 60 miles (6.9 km) from the
Massachusetts eyrie cited in this table (11).
They were next inferred in Quebec in 1948
when egg-eating was observed at the same
site in 1949 (12), and were observed in
Pennsylvania in 1949 and 1950 (IS). Chlori-
nated hydrocarbon data for this now-extinct
regional population are completely absent.
For nine surviving adult peregrines in Canada's
Northwest Territories in 1966, the data are
reported to have averaged 369 parts per mil-
lion (ppm) (fresh weight) in fat (H). For
four adults in another migratory population
in northern Alaska, values were even higher
(IS).
For the five other raptorial species we have
studied, the data do not permit a precise de-
lineation of the onset of the change in cal-
cium metabolism or mobilization, but the
decrease (Table 1) in shell weight (and
hence thickness) has involved only declin-
-------
STATUTES AND LEGISLATIVE HISTORY
1335
ing populations and not stationary ones.
Change in shell thickness occurs in poultry
as a result of dietary deficiencies and age
(16. 17). This phenomenon would probably
[p. 29006]
not occur simultaneously on two continents
1 year after the chlorinated hydrocarbon in-
secticides came into general usage. Other
chemicals affect shell thickness in poultry
(17), but the finding of high concentrations
of chlorinated hydrocarbons in the eggs of
wild populations of raptors and the time
correlation of shell changes with the intro-
duction of DDT [l,l,l-trichloro-2,2,-bis (p-chlo-
rophenyl) ethane] tend strongly to suggest
that chlorinated hydrocarbons are the major
contributing cause, although it is not unlikely
that other chemicals could be contributory.
TABLE 1—WEIGHTS OF RAPTOR EGGSHELLS IN MUSEUM AND PRIVATE COLLECTIONS
Weight (g)
Population
Region
Red-tailed hawk: California (23)'
Golden eagle: California (23)
Bald eagle (24a):
Brevard County, Fla
Osceola County, Fla.
Osprey (24b):
Maryland-Virginia
New Jersey
Peregrine (25):
British Columbia
California (23)
New Hampshire to New Jersey1...
Vermont
Massachusetts.
New Jersey
Great horned owl:
California (23)
Period Number
1885-1937
1943-44
1953-67
1889-1939
1940-46
1947-65
1886-1939
1947-62
1901-44
1959-62
1890-1938
1940-46
1955
1880-1938
1957
1915-37
1947-53
1895-1939
1940-46
1947-52
1888-1932
1946
1947
1950
1886-1936
1948-50
386
6
8
278
28
33
56
12
25
8
152
21
117
6
29
15
235
49
31
56
3
.1
154
12
Mean±S.E.2 Change (percent)
6.32±0.032
6.09±0.237
6.49±0.214
13.03±0.083
12.70±0.161
13.41±0.232
12.15±0.127
9.96±0.280
12.32±0.240
9.88±0.140
7.05±0.054
6.91±0.164
6.85
7.08±0.069
5.30±0.446
4.24±0.061
4.18±0.081
4.20±0.031
4.07±0.038
3.41±0.084
4 38±0.034
4.30
3.47
3.24
4 50±0.033
4.62±0.119
-3.6
+2.7
-2.5
+2.9
-18.0
-19.8
-2.0
-2.8
-25.1
-1.4
-3.1
-18.8
-1.8
-20.8
-26.0
+2.4
reproduction)
Stationary.
Do.
Do.
Do.
Declining.
Do.
Stationary.
Do.
Do.
Declining.
Stationary.
No data.
Declining.
Stationary.
Extirpated.
Do.
Stationary.
1 Citations (23-25) refer to the data for the population trend.
' S.E., standard error of the mean.
1 Including Vermont and Massachusetts.
In order to test the hypothesis that these
recent changes of thickness in raptor egg-
shells were the result of differences in expo-
sure to chlorinated hydrocarbons we ana-
lyzed 10 to 14 eggs taken in 1967 from each
of five colonies of the herring gull (Larus
argentatus). Mean shell weight and thick-
ness in 55 eggs collected in the same five
states prior to 1947 disclosed no geographic
gradients or significant differences. The
1967 mean thicknesses for each colony were
therefore compared to mean levels of resid-
ual DDE [l,l-dichloro-2,2-bis (p-chlorophenyl)
ethylene] on a fresh-weight basis, with the
result shown in Fig. 2, the r value being sig-
nificant, with P = .001. The residues of poly-
chlorinated biphenyls (18) have not been
studied in these ecosystems, but DDE has been
consistently high in the Lake Michigan birds,
averaging (fresh weight) 1925 ppm (S.E. 274)
in the fat of 12 healthy adults collected in
1963-64 (19).
Reproduction in these gull colonies was
generally normal in 1967 except perhaps in
Wisconsin. At the latter colony where an 11
percent mean decrease in shell thickness oc-
curred, some egg breakage and shell flaking
was evident in 1967, although not at the fre-
quency seen in previous years. Excessive re-
productive failure occurred at this site in
1964 when about 18 percent of eggs lost
about one-third of the shell due to flaking,
when clutch size decreased and embryonic
mortality was high, and when DDE residues
averaged 202 ppm (S.E. 34) in nine eggs
(20), (If linear extrapolation of the 1967
values is carried out to 202 ppm, the shell
thickness in 1964 could be estimated as hav-
ing decreased by about 32 percent.) The
effectiveness of DDE in the enzymatic me-
tabolism of aminopyrine has been reported
by Hart and Fouts (21), and our data sug-
gest that this compound, because of its
prevalence, has played a major role in in-
-------
1336
LEGAL COMPILATION—PESTICIDES
ducing the hepatic microsomal metabolism
of steroids that In turn resulted in the egg-
shell changes we have encountered in muse-
um collections. Without doubt DDE ia the
commonest insecticide or insecticide analog
now being found in avian tissues (22). In
1966, it was found to average 284 ppm (S.E.
62) in the fat of nine arctic-breeding pere-
grine falcons (H) and about 414 ppm in
four others on a wet-weight basis (15).
Concentrations of this compound and other
chlorinated hydrocarbons in the peregrine
populations that crashed farther south can
be assumed to have been as high—and they
may have been much higher.
From the above evidence and that accu-
mulated by others (t, 4. e, 8), we have reached
these conclusions: (i) many of the recent
and spectacular raptor population crashes in
both the United States and Western Europe
have had a common physiological basis; (ii)
eggshell breakage has been widespread but
largely overlooked in North America; (iii)
significant decreases in shell thickness and
weight are characteristic of the unprece-
dented reproductive failures of raptor popu-
lations in certain parts of the United States;
(iv) the onset of the calcium change 1 year
after the introduction of chlorinated hydro-
carbons into general usage was not a ran-
dom circumstance; and (v) these persisting
compounds are having a serious insidious
effect on certain species of birds at the tops
of contaminated ecosystems.
JOSEPH J. HICKEY.
DANIEL W. ANDERSON,
Department of Wildlife Ecology, Uni-
versity of Wisconsin, Madison.
REFERENCES AND NOTES
1. E. G. Hunt and A. I. Bischoff, Calif. Fish
Game 46, 91 (1960); review in R. L. Rudd,
Pesticides and the Living Landscape (Univ.
of Wisconsin Press, Madison, 1964), pp.
248-264.
2. C. Demandt, Ornithol. Mitt. 1, 6 (1956);
P. Linkola, Suomen Luonto 18, S, 34 (1959);
P. Linkola, ibid. 19, 20 (1960); P. Linkola.
ibid. 23, 6 (1964); K. Kleinstauber, Falke 10,
80 (1963); C. Kruyfhooft, in Working Con-
ference on Birds of Prey and Owls (Inter-
national Council Bird Protection, London,
1964), p. 70; J. F. Terrasse, ibid., p. 78.
3. D. D. Berger, C. R. Sindelar, Jr., K. E.
Gamble, in Peregrine Falcon Populations:
Their Biology and Decline, J. J. Hickey, Ed.
(Univ. of Wisconsin Press, Madison, 1968),
p. 166.
4. D. A. Ratcliffe, Bird Study 10, 66 (1963).
6. , Brit. Birds 61, 23 (1958).
6. . Nature 216. 208 (1967).
7. D. B. Peakall, ibid. 216, 505 (1967); L. G.
Hart, R. W. Shulties, J. R. Fouts, Toxicol.
Appl. Pharmacol. 6, 371 (1963); A. H. Con-
ney. Pharmacol. Rev. 19, 317 (1967); D.
Kupfer, Residue Rev. 19, 11 (1967).
8. J. J. Hickey. Ed., Peregrine Faleon Pop-
ulations: Their Biology and Decline (Univ.
of Wisconsin Press, Madison, 1968).
9. U.S. Food and Drug Administration,
Pesticide Analytical Manual, vol. 1 [U.S.
Dept. of Health, Education, and Welfare,
FDA Adm. Fubl. (1963, revised 1964 and
1965)].
10. B. Glading, in Hickey (8), p. 96.
11. J. A. Hagar, in Hickey (S), p. 123.
12. G. H. Hall, Brit. Birds 61, 402 (1968).
13. J. N. Rice, in Hickey (S), p. 156.
14. J. H. Enderson and D. D. Berger,
Condor 70, 149 (1968).
16. T. J. Cade, C. M. White, J. R. Haugh,
ibid., p. 170.
16. A. L. Romanoff and A. J. Romanoff, The
Avian Egg (Wiley, New York, 1949), pp. 154-
167.
17. T. G. Taylor and D. A. Stringer, in
Avian Physiology, P. D. Sturkie, Ed. (Cornell
Univ. Press, Ithaca, N.Y., ed. 2, 1965), p. 486.
18. D. C. Holmes, J. H. Simmons, J. O'G.
Tatton, Nature 216, 227 (1967).
19. J. J. Hickey, J. A. Keith, F. B. Coon, J.
Appl. Ecol. S (suppl.), 141 (1966).
20. J. A. Keith, J. Appl. Ecol 3 (suppl.), 57
(1966).
21. L. G. Hart and J. R. Fouts, Arch. Exp.
Pa.ih.ol. Pharmakol 249, 486 (1965).
22. E. H. Dustman and L. F. Stickel,
Amer. Sac. Agron, Spec. Publ. 8, 109 (1966).
23. J. B. Dixon, B. Glading, W. C. Hanna, E.
N. Harrison, S. B. Peyton, personal com-
munication.
24a. A. Sprunt, IV, personal communica-
tion.
24b. W. A. Stickel in Hickey (S), p. 337.
25. Except for the California data (US) the
data on population trends are given in (8)
by F. L. Beebe for British Columbia; by W. R.
Spofford for Vermont; by J. A. Hagar for
Massachusetts; and by D. D. Berger et al. for
New Jersey.
26. Research carried out under contract
with the Bureau of Sport Fisheries and Wild-
life, Fish and Wildlife Service, U.S. Dept of
Interior. W. H. Drury, J. T. Emlen and M. E.
Slate provided gull eggs for analysis. E. N.
Harrison, W. C. Hanna, and many other zoolo-
gists greatly facilitated our measurements of
eggshells. We thank D. A. Ratcliffe for advice
throughout the entire study.
16 July 1968
Mr. PROXMIBE. Mr. President, I
have an amendment at the desk and
I ask that it be stated.
The PRESIDING OFFICER. The
amendment will be stated.
The ASSISTANT LEGISLATIVE CLERK.
The Senator from Wisconsin proposes
-------
STATUTES AND LEGISLATIVE HISTORY
1337
an amendment, on page 73, line 24,
insert the following new section:
SBC. 109. Section 1706 (h) of Public Law
90-448 is amended by striking the word "or"
where it appears before the word "domitory"
and by inserting after the word "domitory"
the following: ", water, or sewer".
Mr. PROXMIRE. Mr. President,
the Water Quality Improvement Act
of 1969 which the Senate is consider-
ing today is mainly concerned with
the control of pollution whether by
oil, sewage flow, acid mine drainage,
or related pollutants into our rivers
and harbors. This bill would author-
ize appropriations to alleviate pol-
[p.29007]
luted conditions and to provide for
better coordination between Federal,
State, and local water pollution con-
trol programs. I congratulate the dis-
tinguished Senator from Maine for
the excellent leadership he has shown
on environmental policy. His work on
the Water Quality Improvement Act
is but one example of his continuing
efforts over the years to combat air
and water pollution.
I understand that the Public Works
Committee will later consider legisla-
tion on the very important subject of
providing additional financing to
State and local governments for the
construction of needed water and
sewer facilities. In 1968, State and
local governments borrowed nearly $3
billion to provide capital for financing
water, sewer, and conservation pro-
grams. The Water Quality Improve-
ment Act of 1968 was passed by the
Senate, but was not enacted into law
because time ran out in the 90th Con-
gress before differences in the House
and Senate versions could be resolved.
This 1968 act would have enabled
State and local government units to
raise between $6 and $7 billion in
capital by means of municipal bond
issues in order to pay for needed con-
struction.
The amendment I offer today would
afford to the State and local govern-
ment units access to the capital mar-
ket now enjoyed by State and local
governments when they issue bonds
for housing, university, and dormitory
purposes. Having access to a competi-
tive capital market will enable the
State and local governments through-
out the country to borrow money for
water and sewer construction at the
lowest possible cost. It is my belief
that in view of the astronomically
high interest rates which are now be-
ing paid, it is more imperative that
new water and sewer construction be
paid for by raising capital under the
most advantageous conditions. Fur-
thermore, as I mentioned earlier, the
fact that the Public Works Committee
has not yet considered legislation re-
lating to financial assistance by the
Federal Government for the raising
of such capital is an additional rea-
son why it is important at this time
that every advantage of a competitive
market be given for State and local
borrowing for water and sewer needs.
Mr. President, the Committee on
Banking and Currency has considered
this amendment in some detail and
hearings have been held on it. The
Senator from Maine (Mr. MUSKIE) is
familiar with the action taken, as he
serves as a member on that commit-
tee. It has also been discussed on the
floor before, and I would hope, as it
is discussed now with the distin-
guished Senator from Maine, that he
will be able to accept the amendment.
Mr. MUSKIE. Mr. President, I sup-
port the adoption of the amendment
offered by my distinguished colleague
from Wisconsin. The Subcommittee
on Air and Water Pollution has given
considerable thought and study as to
how capital is to be available to our
hard-pressed States and cities for the
construction of waste treatment fa-
cilities. I believe that every Member
of Congress is aware of the acute need
in every State and community for
such facilities. Many different financ-
-------
1338
LEGAL COMPILATION—PESTICIDES
ing proposals have been considered
by the subcommittee and by the full
Public Works Committee. The Clean
Water Restoration Act of 1966 author-
ized $3.5 billion for substantial Fed-
eral grants for this purpose. How-
ever, appropriations have fallen far
short of the authorized amounts. This
situation will be partially rectified
this year if the Congress appropri-
ates the amounts included by the
House Appropriations Committee in
the Public Works appropriations bill.
In the meantime, State and local
government units have continued to
raise the capital for both their share
and the Federal share of a project
cost by the issuance of bonds. They
will continue to raise needed State
and local capital by this method in
the future. The amendment now under
consideration would enable the pub-
lic issuers to have access to the same
capital markets now available for
Federal financing thereby insuring
that they may borrow in a competi-
tive market at the lowest cost.
Mr. President, for many reasons
the amendment is thoroughly consist-
ent with the objectives of the com-
mittee, struggling against budgetary
restrictions over the past 3 or 4 years,
to find alternative ways to make it
possible for States and communities
to find the capital to build these facili-
ties.
I compliment the Senator for offer-
ing his proposal. It has been heard by
committees. It is demonstrably sound
on the basis of the hearings held, and
I am delighted to take the amendment
into the bill.
The PRESIDING OFFICER. The
question is on agreeing to the amend-
ment offered by the Senator from
Wisconsin.
The amendment was agreed to.
Mr. MUSKIE. Mr. President, I
suggest the absence of a quorum.
The PRESIDING OFFICER. The
clerk will call the roll.
The assistant legislative clerk pro-
ceeded to call the roll.
Mr. BYRD of West Virginia. Mr.
President, I ask unanimous consent
that the order for the quorum call be
rescinded.
The PRESIDING OFFICER. With-
out objection, it is so ordered.
[p. 29008]
1.18a(4) (c) VOL. 115 (1969), Oct. 8: Passed Senate, p. 29099
[No Relevant Discussion on Pertinent Section]
1.18a(4)(d) VOL. 116 (1970), March 24: Senate agrees to con-
ference report, p. 4424
[No Relevant Discussion on Pertinent Section]
1.18a(4)(e) VOL. 116 (1970), March 25: House agrees to con-
ference report, p. 9334
[No Relevant Discussion on Pertinent Section]
1.18b FEDERAL WATER POLLUTION CONTROL ACT
AMENDMENTS OF 1972
October 18,1972, P.L. 92-500, 3 104 (e), 86 Stat. 822
AN ACT
To amend the Federal Water Pollution Control Act.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, That this Act
-------
STATUTES AND LEGISLATIVE HISTORY 1339
may be cited as the "Federal Water Pollution Control Act Amend-
ments of 1972".
SEC. 2. The Federal Water Pollution Control Act is amended to
read as follows:
"TITLE I—RESEARCH AND RELATED PROGRAMS
******
SEC. 104
******
"(1) (1) The Administrator shall, after consultation with ap-
propriate local, State, and Federal agencies, public and private
organizations, and interested individuals, as soon as practicable
but not later than January 1, 1973, develop and issue to the States
for the purpose of carrying out this Act the latest scientific knowl-
edge available in indicating the kind and extent of effects on health
and welfare which may be expected from the presence of pesticides
in the water in varying quantities. He shall revise and add to such
information whenever necessary to reflect developing scientific
knowledge.
1.18b(l) SENATE COMMITTEE ON PUBLIC WORKS
S. REP. No. 92-414, 92d Cong., 1st Sess. (1971)
FEDERAL WATER POLLUTION CONTROL ACT
AMENDMENTS OF 1971
OCTOBER 28,1971.—Ordered to be printed
Mr. RANDOLPH, from the Committee on Public Works, submitted
the following
REPORT
together with
SUPPLEMENTAL VIEWS
[To accompany S. 2770]
The Committee on Public Works, to which was referred the bill
(S. 2770) Federal Water Pollution Control Act Amendments of
1971, having considered the same, reports favorably thereon with-
out amendment and recommends that the bill do pass. An original
bill (S. 2770) is reported in lieu of S. 523, S. 1012, S. 1013, S. 1014,
S. 1017 and S. 1238 which were considered by the committee.
-------
1340 LEGAL COMPILATION — PESTICIDES
DISCUSSION OF INTENT
TITLE I— RESEARCH AND RELATED PROGRAMS
SECTION 104 — RESEARCH, INVESTIGATIONS, TRAINING, AND
INFORMATION
The authority of the Administrator in support of research pro-
grams to prevent and eliminate water pollution is continued and
expanded.
The Administrator is authorized to establish field research lab-
oratories in six sections of the Nation and to study the nature of
river systems and sewage in rural areas. Authorization for a one-
year study of problems associated with the disposal of waste oils,
such as lubricating oils, is included in this section.
New authorizations in this section also provide for research into
means to reduce unnecessary water consumption, as well as re-
search, in cooperation with the Secretary of Agriculture, on prob-
lems associated with the control of agricultural pollution. Ten
million dollars is authorized in fiscal year 1972, and annually
thereafter, for this agricultural pollution research.
Another $7,500,000 is authorized in fiscal year 1972 to continue
a pilot training program for personnel to operate and maintain
treatment works. In fiscal year 1972 $2,500,000 is authorized to
continue work on the forecasting of employment needs in water
pollution control. In addition to such special authorizations, there
is a general authorization for this section of $65,000,000 in fiscal
year 1972, $70,000,000 in fiscal year 1973, $75,000,000 in fiscal year
1974, and $80,000,000 in fiscal year 1975.
r
LP-
Water pollution resulting from agricultural production is clearly
a growing problem of great magnitude and complexity. Agriculture
is now one of the major contributors to the degregation of the
quality of our navigable water. The basic problem is one of man-
aging the inputs and outputs of agricultural production to main-
tain the quality of the water, air, and soil environment while
economically producing food and fiber.
Progress has been made in agricultural research but we must go
beyond it to meet the present challenge. Until we compile adequate
identification, analysis, and evaluation of existing programs and
methods ; vigorously study alternative production decisions avail-
able to [p. 15]
agricultural producers at various steps of the production process ;
and develop information of about the social, legal, and economic
impacts of these methods, we will have little impact on the
enormous problem of agricultural water pollution.
-------
STATUTES AND LEGISLATIVE HISTORY 1341
Subsection (p) provides that the Administrator shall carry out
a comprehensive study and research program to determine new
and improved methods of preventing and controlling water pollution
from agriculture, including legal, economic, and other implications
of the use of such methods.
[p. 161
SUPPLEMENTAL VIEWS OP SENATOR BOB DOLE
The bill reported by the committee adopts many of the proposals
offered by the President in his February 10, 1971, environmental
message and has been developed through a long process of consul-
tation and discussion between the committee and the administra-
tion.
A major new thrust of this bill is in the field of agricultural pol-
lution, and as a Senator from an agricultural State and a member
of the Senate Agriculture Committee, this matter is of great inter-
est to me and my State.
The bill would amend the Federal Water Pollution Control Act to
place responsibility on the States for instituting and expanding the
control of water pollution related to agriculture. To assist the
States in this effort, the Environmental Protection Agency, work-
ing closely with the Department of Agriculture, is directed by the
bill to provide technical expertise and in some cases financial assis-
tance for combatting this serious, yet extremely complex, form
of pollution. A total of $10 million is provided for agricultural
research.
This bill recognizes that the U.S. Department of Agriculture and
the agricultural community in general have made great strides in
improving the quality of the environment; therefore, the bill does
not attempt to parallel or duplicate the contributions already made
but seeks to incorporate them into the framework of the act.
The committee report discusses the operative provisions of the
bill in considerable detail and describes some of the problems asso-
ciated with agricultural pollution. Since this is a new area for
pollution control legislation, I would like to discuss some of the
more important aspects of this area which lie within the scope of
the bill's operations.
Agricultural pollution control is concerned primarily with the
following:
Sedimentation
Animal wastes
Fertilizers
Pesticides, Fungicides and Herbicides
Forest and crop residues
-------
1342 LEGAL COMPILATION—PESTICIDES
Agricultural processing wastes
Inorganic salts and minerals
The management and control of these factors are essential to the
maintenance of environmental quality while providing food and
fiber products in abundant quantity. At the outset, I believe it is
important to recognize that we are undertaking the first step in
establishing an overall water pollution control system. Before solu-
tions can be effected, we must, first identify and define the prob-
lems which face us, and second, we must then take into account
the available means of control and the costs of each type of control.
I believe discussion of three specific problem areas—pesticides,
animal wastes and fertilizers—will be helpful in understanding
the complexity of the agricultural problem and at the same time
indicate the need for coordinated control programs.
Most of the problems of agricultural pollution deal with non-
point sources. Very simply, a non-point source of pollution is one
that does not confine its polluting discharge to one fairly specific
outlet, such [p 9g]
as a sewer pipe, a drainage ditch or a conduit; thus, a feedlot
would be considered to be a non-point source as would pesticides
and fertilizers.
PESTICIDES, HERBICIDES AND FUNGICIDES
Pesticides provide substantial benefits to mankind by protecting
plants and animals from pest losses. It has been estimated that
without pesticides, food production would be reduced by 40 to 50
percent, with substantial accompanying reductions in quality also.
Approximately 50,000 species of fungi cause more than 1,500
plant diseases; of about 30,000 species of weeds 1,800 cause serious
economic losses each year; and nearly 1,500 varieties of nematodes
cause significant damage. In addition, there are more than 10,000
species of insects capable of causing large losses in food, feed and
fiber production. A number of agricultural chemicals are used to
control these problems, and their ecological impact must be taken
into account in the formulation of agricultural production pro-
grams.
The chief hazard of pesticide use lies in the long-lasting proper-
ties possessed by many of them. Some, such as DDT, retain their
potency for virtually unlimited periods after application, their
residues are introduced into the complicated food chains at work
in nature, and, ultimately, they become concentrated at levels
which are hazardous to both animal and human life.
Pesticide residues are of concern in three ways. First, residues
-------
STATUTES AND LEGISLATIVE HISTORY 1343
become attached to soil particles and may reach water through
runoff and erosion. Second, some crops pick up and accumulate
excess residues when irrigated with water contaminated through
runoff erosion.
Third pesticide residues in water are picked up at low levels by
certain marine organisms which result in relatively high concen-
trations being reached in organisms at the top of the food chain.
The use of pesticides and other agricultural chemicals will un-
doubtedly retain a high level of importance in agriculture for the
foreseeable future. In the meantime efforts at both State and Fed-
eral levels are paying off in securing the registration and adherence
to recommended usages. Increased research is underway to develop
alternative means of pest, weed and fungal control. Experiments
are underway to develop integrated programs in which cultural,
mechanical, chemical and biological methods are combined to
achieve the greatest degree of control at the least expense to the
environment.
Every possible effort must be made to see that in achieving con-
trol appropriate chemicals are applied at carefully controlled min-
imum rates. Off-target applications must be reduced, and soil and
water conservation measures must be utilized to prevent movement
of chemicals through runoff and erosion.
The ideal solution to the problem of pesticide residues would be
to employ only pesticides which degrade after application and leave
no toxic or hazardous after-products. The difficulty in this solution,
however, appears to be that the available alternative chemicals
which are non-persistent are extremely toxic to human life in the
forms in which they are effective in pest control.
Immediate dangers to human life are posed by these extremely
toxic chemicals, such as parathion which has been recommended
as a substitute for DDT. These substances, commonly referred to
as"hot"chem- [p 99]
icals, are recommended for use because they do attack the pests
against which persistent chemicals have proven effective, but they
do not persist in their toxic state for long periods after application.
Shortly after application, these chemicals start to disintegrate
and are soon absorbed by natural processes leaving no residual
accumulation to endanger wildlife or man. The difficulty in their
use arises out of their high original toxicity. These chemicals
cause most of the deaths from pesticides in the Nation. Mere
exposure to dust from a parathion sack has resulted in the death
of children, and farmers, justifiably, are fearful to use these
"hot" chemicals. r
-------
1344 LEGAL COMPILATION—PESTICIDES
1.18b(2) HOUSE COMMITTEE ON PUBLIC WORKS
H.R. REP. No. 92-911,92d Cong., 2d Sess. (1972)
FEDERAL WATER POLLUTION CONTROL ACT
AMENDMENTS OF 1972
MARCH 11, 1972.—Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
Mr. BLATNIK, from the Committee on Public Works, submitted
the following
REPORT
together with
ADDITIONAL AND SUPPLEMENTAL VIEWS
[To accompany H.R. 11896]
The Committee on Public Works, to whom was referred the bill
(H.R. 11896) to amend the Federal Water Pollution Control Act,
having considered the same, report favorably thereon with an
amendment and recommend that the bill as amended do pass.
Strike out all after the enacting clause and insert in lieu thereof
the following:
That this Act may be cited as the "Federal Water Pollution Control Act
Amendments of 1972".
SEC. 2. The Federal Water Pollution Control Act is amended to read as
follows:
"TITLE I—RESEARCH AND RELATED PROGRAMS
[P.1]
"RESEARCH, INVESTIGATIONS, TRAINING, AND INFORMATION
"SEC. 104.
* * * * *
"(1) (1) The Administrator shall, after consultation with appropriate local,
State, and Federal agencies, public and private organizations, and interested
individuals, as soon as practicable but not later than October 3, 1972, develop
and issue to the States for the purpose of carrying out this Act the latest scien-
tific knowledge available in indicating the kind and extent of effects on health
and welfare which may be expected from the presence of pesticides in the water
in varying quantities. He shall revise and add to such information whenever
necessary to reflect developing scientific knowledge.
"(2) The President shall, in consultation with appropriate local, State, and
Federal agencies, public and private organizations, and interested individuals,
conduct studies and investigations of methods to control the release of pesticides
into the environment which study shall include examination of the persistency
of pesticides in the water environment and alternatives thereto. The President
shall submit reports, from time to time, on such investigations to Congress
together with his recommendations for any necessary legislation.
[p. 5]
-------
STATUTES AND LEGISLATIVE HISTORY 1345
ANALYSIS OP THE BILL
Section 2.—
Section 104.—Research, Investigations, Training and Informa-
tion.
*****
Subsections (d), (e), (g), (h), (i), (k), and (1) are basically ex-
tensions of the existing law with relatively minor changes.
In regard to these subsections the following items should be
noted: (1) The rewriting of subsection (e) does not increase the
number of authorized laboratories at any one area of the country,
(2) the report relating to training required by subsection (g) (4) is
meant to be a new report, and not in lieu of previously authorized
reports, (3) the reference to cooperation with the Coast Guard in
subsection (i) is to indicate that the Committee recognizes the
extremely important role of that agency in this program, and
expects that the Administrator will work closely with the Coast
Guard in a manner which would preclude any differences as to
which agency is the lead agency, (4) the Administrator is granted
a 6-month extension on the requirements of subsection (1) (1) and
the reports required by subsection (1) (2) are in addition to and
not in lieu of the report required in the existing law.
[p. 81]
1.18b(3) COMMITTEE OF CONFERENCE
H.R. REP. 92-1465 92d Cong., 2d Sess. (1972)
[No Relevant Discussion on Pertinent Section]
1.18b(4) CONGRESSIONAL RECORD:
1.18b(4)(a) VOL. 117 (1971), Nov. 2: Considered and passed
Senate
[No Relevant Discussion on Pertinent Section]
1.18b(4) (b) VOL. 118 (1972), Mar. 27-29; Considered and passed
House, amended
[No Relevant Discussion on Pertinent Section]
1.18b(4)(c) VOL. 118 (1972), Oct. 4. House and Senate agreed
to conference report
[No Relevant Discussion on Pertinent Section]
1.18b(4)(d) VOL. 118 (1972), Oct. 18. Senate and House over-
rode veto
[No Relevant Discussion on Pertinent Section]
-------
1346 LEGAL COMPILATION—PESTICIDES
1.19 INTEREST ON CERTAIN GOVERNMENT OBLIGATIONS,
AS AMENDED
26 U.S.C. §103
(See "General 1.9a-1.9b" for legislative history)
§103. Interest on certain governmental obligations
(a) General rule.—Gross-income does not include interest on—
(1) the obligations of a State, a Territory, or a possession
of the United States, or any political subdivision of any of the
foregoing, or of the District of Columbia;
(2) the obligations of the United States; or
(3) the obligations of a corporation organized under Act of
Congress, if such corporation is an instrumentality of the
United States and if under the respective Acts authorizing
the issue of the obligations the interest is wholly exempt from
the taxes imposed by this subtitle.
(b) Exception.—Subsection (a) (2) shall not apply to interest
on obligations of the United States issued after September 1, 1917
(other than postal savings certificates of deposit, to the extent
they represent deposits made before March 1, 1941), unless under
the respective Acts authorizing the issuance thereof such interest
is wholly exempt from the taxes imposed by this subtitle.
(c) Industrial development bonds.—
(1) Subsection (a) (1) not to apply.—Except as otherwise
provided in this subsection, any industrial development bond
shall be treated as an obligation not described in subsection
(a) (1).
(2) Industrial development bond.—For purposes of this
subsection, the term "industrial development bond" means
any obligation—
(A) which is issued as part of an issue all or a major
portion of the proceeds of which are to be used directly
or indirectly in any trade or business carried on by any
person who is not an exempt person (within the meaning
of paragraph (3)), and
(B) the payment of the principal or interest on which
(under the terms of such obligation or any underlying
arrangement) is, in whole or in major part—
(i) secured by any interest in property used or to
be used in a trade or business or in payments in
respect of such property, or
(ii) to be derived from payments in respect of
property, or borrowed money, used or to be used in a
trade or business.
-------
STATUTES AND LEGISLATIVE HISTORY 1347
(3) Exempt person.—For purposes of paragraph (2) (A),
the term "exempt" person means—
(A) a governmental unit, or
(B) an organization described in section 501 (c) (3)
and exempt from tax under section 501 (a) (but only
with respect to a trade or business carried on by such
organization which is not an unrelated trade or business,
determined by applying section 513(a) to such organiza-
tion) .
(4) Certain exempt activities.—Paragraph (1) shall not
apply to any obligation which is issued as part of an issue sub-
stantially all of the proceeds of which are to be used to
provide—
(A) residential real property for family units,
(B) sports facilities,
(C) convention or trade show facilities,
(D) airports, docks, wharves, mass commuting facili-
ties for the local furnishing of electric energy or gas,
directly related to any of the foregoing,
(E) sewage or solid waste disposal facilities or facili-
ties for the local furnishing of electric energy or gas,
(F) air or water pollution control facilities, or
(G) facilities for the furnishing of water, if available
on reasonable demand to members of the general public.
*******
Aug. 16, 1954, c. 736, 68A Stat. 29; Dec. 10, 1971, Pub.L. 92-178,
Title III, §315 (a), 85 Stat. 529.
1.20 AMORTIZATION OF POLLUTION CONTROL FACILI-
TIES, AS AMENDED
26 U.S.C. §169 (1969)
(See, "General 1.4a-1.4a(5) (c)" for legislative history)
§169. Amortization of pollution control facilities
(a) Allowance of deduction.—Every person, at his election, shall
be entitled to a deduction with respect to the amortization of the
amortizable basis of any certified pollution control facility (as
defined in subsection (d), based on a period of 60 months. Such
amortization deduction shall be an amount, with respect to each
month of such period within the taxable year, equal to the amor-
tizable basis of the pollution control facility at the end of such
month divided by the number of months (including the month for
which the deduction is computed) remaining in the period. Such
-------
1348 LEGAL COMPILATION—PESTICIDES
amortizable basis at the end of the month shall be computed with-
out regard to the amortization deduction for such month. The
amortization deduction provided by this section with respect to
any month shall be in lieu of the depreciation deduction with
respect to such pollution control facility for such month provided
by section 167. The 60-month period shall begin, as to any pollu-
tion control facility, at the election of the taxpayer, with the
month following the month in which such facility was completed
or acquired, or with the succeeding taxable year.
(b) Election of amortization—The election of the taxpayer to
take the amortization deduction and to begin the 60-month period
with the month following the month in which the facility is com-
pleted or acquired, or with the taxable year succeeding the taxable
year in which such facility is completed or acquired, shall be made
by filing with the Secretary or his delegate, in such manner, in
such form, and within such time, as the Secretary or his delegate
may by regulations prescribe, a statement of such election.
(c) Termination of amortization deduction.—A taxpayer which
has elected under subsection (b) to take the amortization deduc-
tion provided in subsection (a) may, at any time after making
such election, discontinue the amortization deduction with respect
to the remainder of the amortization period, such discontinuance
to begin as of the beginning of any month specified by the tax-
payer in a notice in writing filed with the Secretary or his delegate
before the beginning of such month. The depreciation deduction
provided under section 167 shall be allowed, beginning with the
first month as to which the amortization deduction does not apply,
and the taxpayer shall not be entitled to any further amortization
deduction under this section with respect to such pollution control
facility.
(d) Definitions.—For purposes of this section—
(1) Certified pollution control facility.—The term "certified
pollution control facility" means a new identifiable treatment
facility which is used, in connection with a plant or other
property in operation before January 1, 1969, to abate or
control water or atmospheric pollution or contamination by
removing, altering, disposing, or storing of pollutants, con-
taminants, wastes, or heat and which—
(A) the State certifying authority having jurisdiction
with respect to such facility has certified to the Federal
certifying authority as having been constructed, recon-
structed, erected, or acquired in conformity with the
State program or requirements for abatement or control
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STATUTES AND LEGISLATIVE HISTORY 1349
of water or atmospheric pollution or contamination; and
(B) the Federal certifying authority has certified to
the Secretary or his delegate (i) as being in compliance
with the applicable regulations of Federal agencies and
(ii) as being in furtherance of the general policy of the
United States for cooperation with the States in the pre-
vention and abatement of water pollution under the Fed-
eral Water Pollution Control Act, as amended (33 U.S.C.
466 et seq.), or in the prevention and abatement of at-
mospheric pollution and contamination under the Clean
Air Act, as amended (42 U.S.C. 1857 et seq.).
(2) State certifying authority.—The term "State certifying
authority" means, in the case of water pollution, the State
water pollution control agency as denned in section 13 (a) of
the Federal Water Pollution Control Act and, in the case of
air pollution, the air pollution control agency as denned in
section 302 (b) of the Clean Air Act. The term "State certify-
ing authority" includes any interstate agency authorized to
act in place of a certifying authority of the State.
(3) Federal certifying authority.—The term "Federal certi-
fying authority" means, in the case of water pollution, the
Secretary of the Interior and, in the case of air pollution, the
Secretary of Health, Education, and Welfare.
(4) New identifiable treatment facility.—For purposes of
paragraph (1), the term "new identifiable treatment facility"
includes only tangible property (not including a building and
its structural components, other than a building which is ex-
clusively a treatment facility) which is of a character subject
to the allowance for depreciation provided in section 167,
which is identifiable as a treatment facility, and which—
(A) is property—
(i) the construction, reconstruction, or erection of
which is completed by the taxpayer after December
31,1968, or
(ii) acquired after December 31, 1968, if the orig-
inal use of the property commences with the tax-
payer and commences after such date, and
(B) is placed in service by the taxpayer before Janu-
ary 1,1975.
In applying this section in the case of property described in
clause (i) of subparagraph (A), there shall be taken into
account only that portion of the basis which is properly at-
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1350 LEGAL COMPILATION—PESTICIDES
tributable to construction, reconstruction, or erection after
December 31,1968.
(e) Profitmaking abatement works, etc.—The Federal certify-
ing authority shall not certify any property under subsection (d)
(1) (B) to the extent it appears that by reason of profits derived
through the recovery of wastes or otherwise in the operation of
such property, its costs will be recovered over its actual useful life.
*******
Aug. 16, 1954, c. 736, 68A Stat. 55, added Pub.L. 91-172, Title
VII, § 704 (a), Dec. 30,1969, 83 Stat. 667.
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Executive
Orders
-------
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EXECUTIVE ORDERS 1353
2.1 E.O. 11643, ENVIRONMENTAL SAFEGUARDS ON
ACTIVITIES FOR ANIMAL DAMAGE CONTROL ON
FEDERAL LANDS
February 9,1972, 37 Fed. Reg. 2875
EXECUTIVE ORDER 11643
Environmental Safeguards on Activities for Animal Damage Con-
trol on Federal Lands
By virtue of the authority vested in me as President of the
United States and in furtherance of the purposes and policies of
the National Environmental Policy Act of 1969 (42 U.S.C. 4321
et seq.) and the Endangered Species Conservation Act of 1969 (16
U.S.C. 668aa), it is ordered as follows:
SECTION 1. Policy. It is the policy of the Federal Government to
(1) restrict the use on Federal lands of chemical toxicants for the
purpose of killing predatory mammals or birds; (2) restrict the
use on such lands of chemical toxicants which cause any secondary
poisoning effects for the purpose of killing other mammals, birds,
or reptiles; and (3) restrict the use of both such types of toxicants
in any Federal programs of mammal or bird damage control that
may be authorized by law. All such mammal or bird damage con-
trol programs shall be conducted in a manner which contributes to
the maintenance of environmental quality, and to the conservation
and protection, to the greatest degree possible, of the Nation's
wildlife resources, including predatory animals.
SEC. 2. Definitions. As used in this order the term:
(a) "Federal lands" means all real property owned by or leased
to the Federal Government, excluding (1) lands administered by
the Secretary of the Interior pursuant to his trust responsibilities
for Indian affairs, and (2) real property located in metropolitan
areas.
(b) "Agencies" means the departments, agencies, and establish-
ments of the executive branch of the Federal Government.
(c) "Chemical toxicant" means any chemical substance which,
when ingested, inhaled, or absorbed, or when applied to or injected
into the body, in relatively small amounts, by its chemical action
may cause significant bodily malfunction, injury, illness, or death,
to animals or man.
(d) "Predatory mammal or bird" means any mammal or bird
which habitually preys upon other animals or birds.
(e) "Secondary poisoning effect" means the result attributable
to a chemical toxicant which, after being ingested, inhaled, or
-------
1354 LEGAL COMPILATION—PESTICIDES
absorbed, or when applied to or injected into, a mammal, bird, or
reptile, is retained in its tissue, or otherwise retained in such a
manner and quantity that the tissue itself or retaining part if
thereafter injested by man, mammal, bird, or reptile, produces the
effects set forth in paragraph (c) of this section.
(f) "Field use" means use on lands not in, or immediately adja-
cent to, occupied buildings.
SEC. 3. Restrictions on Use of Chemical Toxicants.
(a) Heads of agencies shall take such action as is necessary to
prevent any Federal lands under their jurisdiction, or in any Fed-
eral program of mammal or bird damage control under their
jurisdiction:
(1) the field use of any chemical toxicant for the purpose of
killing a predatory mammal or bird; or
(2) the field use of any chemical toxicant which causes any sec-
ondary poisoning effect for the purpose of killing mammals, birds,
or reptiles.
(b) Notwithstanding the provisions of subsection (a) of this
section, the head of any agency may authorize the emergency use
on Federal lands under his jurisdiction of a chemical toxicant for
the purpose of killing predatory mammals or birds, or of a chemi-
cal toxicant which causes a secondary poisoning effect for the pur-
pose of killing other mammals, birds, or reptiles, but only if in each
specific case he makes a written finding, following consultation
with the Secretaries of the Interior, Agriculture, and Health, Edu-
cation, and Welfare, and the Administrator of the Environmental
Protection Agency, that any emergency exists that cannot be dealt
with by means which do not involve use of chemical toxicants, and
that such use is essential:
(1) to the protection of the health or safety of human life;
(2) to the preservation of one or more wildlife species threat-
ened with extinction, or likely within the foreseeable future to
become so threatened; or
(3) to the prevention of substantial irretrievable damage to
nationally significant natural resources.
SEC. 4. Rules for Implementation of Order. Heads of agencies
shall issue such rules or regulations as may be necessary and ap-
propriate to carry out the provisions and policy of this order.
RICHARD NIXON.
-------
Regulations
-------
-------
REGULATIONS 1357
REGULATIONS
3.1 Regulations for the Enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act, U.S. Environmental Protec-
tion Agency, 40 C.F.R. §162.1-162.36 (1971).
3.2 Interpretations, Regulations for the Enforcement of FIFRA,
U.S. Environmental Protection Agency, 40 C.F.R. §162.100-
162.125 (1971).
3.3 Certification of Usefulness of Pesticide Chemicals, U.S. En-
vironmental Protection Agency, 40 C.F.R. §163.1-163.12
(1971).
3.4 Rules Governing the Appointment, Compensation, and Pro-
ceedings of an Advisory Committee; and Rules of Practice
Governing Hearings Under the Federal Insecticide, Fungicide,
and Rodenticide Act, U.S. Environmental Protection Agency,
40 C.F.R. §164.1-164.44 (1972).
3.5 FAA Certification of Private Agricultural Operations, Fed-
eral Aviation Administration, 14 C.F.R. §137.1-137.77 (1968).
3.6 Tolerances and Exemptions from Tolerances for Pesticide
Chemicals in or on Raw Agricultural Commodities, U.S.
Environmental Protection Agency, 40 C.F.R. §180.1-180.1023
(1972).
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-------
Guidelines and
Reports
-------
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GUIDELINES AND REPORTS
1361
4.1 INTERDEPARTMENTAL AGREEMENTS
4.1a INTERDEPARTMENTAL AGREEMENT FOR PROTEC-
TION OF PUBLIC HEALTH AND QUALITY OF ENVIRONMENT
BETWEEN DEPARTMENTS OF AGRICULTURE, INTERIOR,
AND HEALTH, EDUCATION, AND WELFARE CONCERNING
ECONOMIC POISONS
March 3,1970 35 Fed. Reg. 4014 (1970)
INTERDEPARTMENTAL AGREE-
MENT FOR PROTECTION OF
PUBLIC HEALTH AND QUALITY
OF ENVIRONMENT
Purpose. Coordination of the activi-
ties of the three Departments per-
taining to economic poisons as defined
in section 2 of the Federal Insecticide,
Fungicide, and Rodenticide Act (7
U.S.C. 135), hereinafter referred to
as pesticides, with reference to the
review of current or proposed regis-
trations to assure maximum protec-
tion of the public health, the well
being of man, and the quality of the
environment.
Existing departmental responsibil-
ities. Each of the three Departments
has certain statutory authority and
responsibility relating to pesticides
in the environment, as set forth
below:
DEPARTMENT OF AGRICULTURE
1. Statutory authority under the
Federal Insecticide, Fungicide, and
Rodenticide Act for registration of
pesticides.
2. Responsibility for research, edu-
cation, information, regulatory, and
action programs designed to protect
the well being of man, crops, live-
stock, forests, ranges, habitats, prod-
ucts, structures, and premises against
arthropod and other invertebrate
pests, weeds, and fungi with equal
concern for the protection of benefi-
cial nontarget organisms and the
quality of the environment.
DEPARTMENT OF HEALTH, EDUCATION,
AND WELFARE
DHEW has the statutory authori-
ty and responsibility under the Fed-
eral Food, Drug, and Cosmetic Act
for establishing safe tolerances for
pesticides in or on raw agricultural
commodities, processed food and po-
table water. The Department also has
responsibilities for protecting the
public from health, occupational, and
environmental hazards related to the
use and disposal of pesticides, and
for other public health aspects such
as the control of diseases and their
vectors.
DEPARTMENT OF INTERIOR
USDI has statutory authority and
responsibility under the Federal
Water Pollution Control Act to carry
out programs, to protect and enhance
the quality of the Nation's waters
including determining the effects of
pesticides in water on health, welfare,
and aquatic life. These responsibili-
ties include establishing water quality
standards for interstate waters. The
Department also has statutory au-
thority for the conservation of wild
birds, fish, mammals, their food orga-
nisms and their environment as
affected by pesticides and the ap-
praisal of effects of pesticides on
fish and wildlife.
Information. Each Department will
keep each of the other Departments
fully informed of developments in
knowledge from research or other
sources which may come into its pos-
session in connection with matters
referred to in this agreement. High
priority shall be placed by each De-
partment representative to respond
to each of the other Departments'
-------
1362
LEGAL COMPILATION—PESTICIDES
requests, whether written or oral,
for any and all information concern-
ing action pending or taken on pes-
ticide matters.
Procedures—A. General. 1. Each
Department will designate a quali-
fied representative to act on 'behalf
of such Department in carrying out
the terms of this agreement. All com-
munications from USDA, DHEW,
and USDI will be directed to these
representatives.
2. USDA shall furnish to the other
Departments copies of each proposal
received for registration or reregis-
tration with the accompanying safety
data (if any) and a request for an
opinion from DHEW and USDI on
the requested action in their areas
of responsibility.
3. Within 15 working days, DHEW
and USDI shall evaluate each regis-
tration or reregistration proposal in
light of the data supplied and offer
an opinion or provide a status report
as to whether or not the registration
should be granted or specify the addi-
tional data deemed necessary before
such evaluation can be made. When
either is unable to assess the public
health or environmental risk without
additional data, USDA shall advise
the registrant of its inability to con-
sider registration of the pesticide
until the additional data requested
have been received and reviewed by
the respective Departments according
to the following procedures described
below.
B. Specific. 1. The Departmental
Representative will accomplish review
by his agency of each proposal and
report results of such review to each
of the other agencies within 15 work-
ing days of the receipt of the pro-
posal. If there is insufficient infor-
mation to reach a decision on the
proposal, USDA will be contacted
within such period of 15 working days
and advised with particularity what
additional information is needed for
the necessary evaluation. Applicants
for registration should not be dis-
couraged from communicating with
DHEW or USDI on registration mat-
ters of mutual interest, so long as
the other representatives are informed
of the details of such contact by
memorandum thereof.
2. Upon receipt of such a request
for further information, the USDA
will make arrangements to obtain
the additional information, if avail-
able, and furnish it to the Depart-
ment making the request. USDA will
withhold final action on the matter
for 15 working days, from the date
of furnishing the requested informa-
tion or advice that such information
is not available, pending receipt of
the report of the other Department
of the results of further review.
3. If a Department concludes that
the registration should be rejected in
whole or in part, this view shall be
expressed in writing along with a
statement of the reasons for the con-
clusion including the specific infor-
mation, lack of information, or scien-
tific judgment upon which these are
based.
Upon being so notified, USDA will
notify the party involved, i.e., the
applicant or registrant, and offer him
an opportunity to submit any data,
views, or arguments with respect to
the proposed rejection and any such
submission shall be promptly referred
to the other Department representa-
tives who shall report to USDA the
results of their review of the sub-
mission.
4. In the event that after the re-
view of the additional data the
Departments cannot agree on the
approval of the proposal, any De-
partment may request the formation
of a Registration Review Panel for
the purpose of making a complete
review of the issues and related infor-
mation or lack thereof and submit a
detailed report of their findings. Each
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GUIDELINES AND REPORTS
1363
Registration Review Panel shall be
composed of two representatives from
each of the three Departments with
the chairman to be selected from the
representatives of the Department
from which the objections have come.
The Registration Review Panel
shall prepare its report within 20
working days, including any minor-
ity opinions, and submit it to each of
the three Departments.
5. The report(s) of the Registra-
tion Review Panel shall be reviewed
by each Department within 15 work-
ing days of its receipt.
6. If significant differences between
the Departments remain still unre-
solved, all data and information sub-
mitted by all parties shall be reviewed
at the first monthly Interdepartment
Pesticide Meeting after the reviews
of the Registration Review Panel
reports have been made.
7. In the event agreement is not
reached among the Department rep-
resentatives at the monthly Inter-
department Pesticide Meeting, a sub-
mission of the reports of the reviews
referred to in paragraphs B-l through
B-6 above, will be referred at the
request of the Secretary of the object-
ing Department to the Cabinet Com-
mittee on Environmental Quality. The
referral shall be accompanied by a
statement prepared by each Depart-
ment analyzing the issues involved
and setting forth the decision it
recommends. The Cabinet Committee
on Environmental Quality will con-
sider such recommendations and
make a written report, either accept-
ing, rejecting, or modifying them.
8. Based upon consideration of the
action of the Cabinet Committee, the
Secretary of Agriculture will make
the decision as to the specific action
to be taken with respect to the matter
on which the Department represent-
atives were not in agreement, and
will thereupon notify the other two
Secretaries in writing in advance of
the publication of the final determi-
nation if he has not followed the
recommendations made by the object-
ing Department (s), specifically stat-
ing his reasons for such action.
9. When registration is granted,
USDA shall supply to DHEW and
USDI final printed labeling at the
time of registration with a copy of
the final letter to the registrant.
10. The Departmental representa-
tives may review existing patterns
of usage and registrations for par-
ticular pesticides. A conclusion by
USDA, DHEW, or USDI that an
existing pesticide use or registration
may be detrimental to the public
health or to the quality of the envi-
ronment shall be transmitted to the
other two Departments together with
the supporting reasoning and infor-
mation, with a recommendation for
corrective action. Written informa-
tion from all sources on the health
or environmental aspects of such pes-
ticides shall be submitted to a Regis-
tration Review Panel for review and
recommendations. If USDA, DHEW,
or USDI disagrees with the recom-
mendations of the Registration Re-
view Panel, that Department can
initiate further review by the proce-
dural steps described in paragraphs
B-6 through B-8 above.
Interdepartment pesticide meetings
and conferences. The Department
representatives will meet jointly at
an Interdepartment Pesticide Meet-
ing once a month to provide a con-
tinuous dialogue concerning all as-
pects of their current activities and
to promote cooperation and under-
standing among the Departments.
Monthly reports concerning their ac-
tivities will be made to the Secretaries
of the three Departments, according
to a mutually agreed upon format.
The Departmental representatives
will arrange a general conference at
least once each year to discuss re-
search needs, research program and
-------
1364
LEGAL COMPILATION—PESTICIDES
policy, and the application of research
findings in action programs, includ-
ing public information relating to
pesticides. The Interdepartment Pes-
ticide Conference will consider broad
questions on policies relating to pes-
ticides involving the interrelation-
ships of control programs, research,
registration, tolerances, the public
health, and general departmental rec-
ommendations to the public.
In order to promote free inter-
change or information among the
Departments involved under this
agreement, each Department repre-
sentative should be invited and en-
couraged to participate in confer-
ences, meetings, and various sympo-
siums with Federal, State, university,
or industry people on possible matters
of mutual interest.
Effective date and supersedure.
This agreement shall become effective
upon signature by the Secretaries of
USDA, USDI, and DHEW, and shall
supersede the agreement entitled "In-
terdepartmental Coordination of Ac-
tivities Relating to Pesticides by the
Department of Agriculture, the De-
partment of Health, Education, and
Welfare, and the Department of the
Interior", published in the FEDERAL
REGISTER on May 1, 1964 (29 F.R.
5808).
Dated: January 28,1970.
CLIFFORD M. HARDIN,
Secretary of Agriculture.
ROBERT H. FINCH,
Secretary of Health,
Education, and Welfare.
WALTER J. HICKEL,
Secretary of the Interior.
4.1b AGREEMENT BETWEEN DEPARTMENT OF HEALTH,
EDUCATION, AND WELFARE AND ENVIRONMENTAL
PROTECTION AGENCY
December 22,1971, 36 Fed. Reg. 24234
AGREEMENT BETWEEN DEPART-
MENT OP HEALTH, EDUCATION,
AND WELFARE AND ENVIRON-
MENTAL PROTECTION AGENCY
Notice Regarding Hatters of Mutual
Responsibility
The Department of Health, Educa-
tion, and Welfare and the Environ-
mental Protection Agency have drawn
up an agreement regarding matters
of mutual responsibility under the
Federal Food, Drug, and Cosmetic
Act and the Federal Insecticide, Fun-
gicide, and Rodenticide Act. It reads
as follows:
DEPARTMENT OF HEALTH, EDUCATION, AND
WELFARE
ENVIRONMENTAL PROTECTION AGENCY
MEMORANDUM OF AGREEMENT REGARDING MAT-
TERS OF MUTUAL RESPONSIBILITY UNDER FEDERAL
FOOD, DRUG, AND COSMETIC ACT AND FEDERAL
INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT
Reorganization Plan No. 3 of 1970 pub-
lished in the FEDERAL REGISTER of October 6,
1970. stated in section 2, paragraph (4) that
the functions vested in the Secretary of
Health, Education, and Welfare of establish-
ing tolerances for pesticide chemicals under
the Federal Food, Drug, and Cosmetic Act, as
amended, 21 U.S.C. 346, 346a, and 348, were
transferred to the Administrator of the
Environmental Protection Agency effective
December 2, 1970. After considering all of the
various pesticide uses which have been sub-
ject to petition procedures under these three
sections, and certain other economic poison
uses subject both to the Federal Insecticide,
Fungicide, and Rodenticide Act, 731 U.S.C.
35, and to the Federal Food, Drug, and
Cosmetic Act, the Administrator of the Envi-
ronmental Protection Agency and the Sec-
retary of Health, Education, and Welfare
have concluded that this agreement is needed
to provide for the coordination of activities
pertaining to economic poisons and to inform
all concerned as to which agency will process
the pesticide petitions for each type of use.
Reorganization Plan No. 3 also transferred
to the Administrator of the Environmental
Protection Agency the functions of the Sec-
retary of Agriculture under the Federal In-
secticide, Fungicide, and Rodenticide Act.
There are certain products which are subject
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GUIDELINES AND REPORTS
1365
to the requirements of both the Federal Food,
Drug-, and Cosmetic Act (FFDCA) and the
Federal Insecticide, Fungicide, and Rodenti-
cide Act (FIFRA). In the past, confusion,
misunderstanding and inconvenience have
resulted from procedures followed in con-
nection with the proposed marketing of such
products. The Administrator of the Environ-
mental Protection Agency (EPA) and the
Secretary of Health, Education, and Welfare
are agreed that a new procedure should be
followed, whereby the manufacturer would
be informed (1) of the agency exercising
primary jurisdiction regarding his product,
(2) that the matter will be referred to the
other agency for decision under the law of
that agency, and (3) that approval for mar-
keting the product will not be granted un-
less or until each agency has approved the
marketing under its respective authority.
This matter was the subject of a proposed
statement of general policy and interpreta-
tion published in the FEDERAL REGISTER on
August 6, 1970.
There are other procedures which should
be established in order to facilitate the han-
dling of matters which are of direct concern
to both agencies. These matters involve is-
suance of regulations under section 406 of the
FFDCA establishment of reference stand-
ards, exchange of information on certain pro-
grams, agreements with States and foreign
countries on surveillance and enforcement
activities on pesticide residues in food and
publication of the Pesticide Analytical Manual.
The term "pesticide chemical" is denned in
section 201 (q) of the Federal Food, Drug,
and Cosmetic Act as a substance which is an
"economic poison" under the Federal Insecti-
cide, Fungicide, and Rodenticide Act and
which is used in the production, storage, or
transportation of raw agricultural commodi-
ties. Economic poisons used on food crops be-
fore or after harvest and on food animals are
included in this category. Economic poisons
used on or concentrating in processed foods
are treated in the Federal Food, Drug, and
Cosmetic Act as food additives rather than
pesticide chemicals.
Both agencies agree that:
1. The following petitions will be processed
by the Environmental Protection Agency:
a. Petitions requesting tolerances or ex-
emption from tolerances for residues of
pesticide chemicals on raw agricultural
commodities.
b. Petitions for food additive regulations
required for residues of pesticide chemicals
carrying over and concentrating in processed
foods manufactured from treated raw agri-
cultural commodities.
c. Petitions for regulations for residues of
economic poisons from direct treatment of
processed foods with fumigants or insecticides.
d. Petitions for food additive regulations
to permit the safe use of economic poisons to
impregnate food-packaging materials such as
wrappers or bags to protect raw agricultural
commodities from any pest or to protect proc-
essed foods from insects.
2. The following petitions will be proc-
essed by FDA:
a. Petitions for food additive regulations to
permit use of sanitizers on food-contact
surfaces.
b. Petitions for food additive regulations
to permit the safe use of economic poisons
and preservatives in processed food.
c. Petitions for food additive regulations
to permit the safe use of economic poisons
in food packaging material when such use is
not covered by l.d.
3. Applications for approval of drugs under
FFDCA and for registration of economic
poisons under FIFRA will be processed as
follows:
a. Whenever a product is submitted to
either FDA or EPA for approval and it is be-
lieved by either agency that the product is
subject to the requirements of both the
FFDCA and the FIFRA, an interagency deter-
mination will be made and an agreement
reached with respect to (1) whether the
product is subject to the requirements of
the FFDCA and FIFRA, (2) whether par-
ticular claims are "economic poison" or "drug"
claims and (3) whether the representations
made for the product, including the impli-
cations to be drawn therefrom, are primarily
"economic poison" or "drug" representations.
b. Whenever application is made to EPA
for registration of a product that is both a
drug and an economic poison and deter-
mination has been made that the principal
claims or representations relate to an eco-
nomic poison, EPA will withhold registration
of the product under FIFRA until it has been
informed by FDA that the product com-
plies with the provisions of the laws admin-
istered by FDA.
c. Whenever application is made to FDA
for approval of a product that is both a drug
and an economic poison and determination
has been made that the principal claims or
representations relate to a drug, FDA will not
approve a new drug application, a new ani-
mal drug application, or an antibiotic appli-
cation without first being advised by EPA
that the claims or representations subject to
the provisions of the FIFRA are warranted
and that the product is eligible for registra-
tion under that act.
d. Whenever application is made to EPA
for the registration of a product that is both
a drug and an economic poison and deter-
mination has been made that the principal
claims or representations relate to a drug,
the matter will be referred by EPA to FDA
and the matter will thereafter be handled
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1366
LEGAL COMPILATION—PESTICIDES
as if the application had been originally made
to PDA.
e. Whenever application is made to FDA
for approval of a product that is both an
economic poison and a drug and determina-
tion has been made that the principal claims
or representations relate to an economic poi-
son, the matter will be referred by FDA to
EPA and the matter will thereafter be han-
dled as if the application had been originally
made to EPA.
f. Neither agency will approve the market-
ing of a product under the law administered
by it if the product would not be in full
compliance with the requirements of a law
administered by the other.
4. If the poisonous or deleterious substance
referred to in section 406 of the Federal
Food, Drug, and Cosmetic Act is present in
food primarily as a result of its use as a
pesticide chemical, or an economic poison,
any regulation establishing a tolerance for
such substance in food will be promulgated
by the Environmental Protection Agency.
Any other regulations under section 406 will
be promulgated by FDA.
B. EPA will have primary responsibility
for maintenance of an analytical reference
standards repository of pesticides for which
tolerances are established. FDA will transfer
to EPA those samples which have been pre-
pared for this purpose. Upon request, por-
tions of these samples will be made available
to the FDA and local enforcement authori-
ties as needed for use in official analysis.
6. Each agency will appoint an individual
and alternates -who shall be responsible for
interagency cooperation and coordination.
a. These representatives, with staff sup-
port as desired, shall meet regularly on a
mutually agreeable schedule to discuss program
and policy coordination and to establish
operating procedures between the agen-
cies. Primary functions of the representa-
tives are: (i) To assure adherence to the
general provsiions of paragraphs 1-4 above,
inclusive; (ii) to promote mutual concur-
rence on chemical, toxicologic, and pharma-
cologic requirements for pesticide tolerances;
(iii) to provide for complete and timely
exchange of information concerning proposed
tolerances, administrative guidelines, meth-
odology, research programs, monitoring, sur-
veillance and enforcement programs, and
legal action; (iv) to provide that FDA wfll
continue responsibility for agreements with
States and foreign countries on surveillance
and enforcement activities on pesticide resi-
dues in food; (v) to provide that where the
official U.S. delegate to international organi-
zations is either EPA or FDA this will not
automatically preclude representation by the
other agency; and (vi) to provide that pub-
lication of FDA's Pesticide Analytical Manual
for residues in foods and other environ-
mental substrates will be continued as a joint
FDA-EPA sponsorship under editorial man-
agement consisting of representatives of both
agencies.
b. Issues arising out of the above provi-
sions which are not resolved after two regu-
larly scheduled meetings shall he submitted
through the organizational structure of each
agency for resolution.
c. Agency representatives may propose
additional agreements concerning these and
other matters affecting interagency coordina-
tion and cooperation on the health aspects
of pesticides and their residues in food and
drugs. These proposals may be jointly ap-
proved by the Deputy Assistant Administra-
tor for Pesticides Programs EPA, and the
Commissioner of Food and Drugs, HEW.
For the Department of Health, Education,
and Welfare.
J. G. VENEMAN,
Acting Secretary.
JUNE 17, 1971.
CHARLES C. EDWARDS,
Commissioner.
MAY 11. 1971.
For the Environmental Protection Agency.
WILLIAM D. RUCKELSHAUS,
Administrator.
SEPTEMBER 4, 1971.
Effective date. This agreement be-
came effective on November 10,1971.
Dated: December 9,1971.
CHARLES C. EDWARDS,
Commissioner of Food and Drugs.
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GUIDELINES AND REPORTS 1367
4.1c INTERAGENCY AGREEMENT BETWEEN THE DE-
PARTMENT OF HEALTH, EDUCATION AND WELFARE AND
THE ENVIRONMENTAL PROTECTION AGENCY FOR JOINT
PARTICIPATION IN THE NATIONAL CENTER FOR TOXI-
COLOGICAL RESEARCH, APRIL 1, 1971
INTERAGENCY AGREEMENT BETWEEN THE DEPART-
MENT OF HEALTH, EDUCATION, AND WELFARE AND THE
ENVIRONMENTAL PROTECTION AGENCY FOR JOINT PAR-
TICIPATION IN THE NATIONAL CENTER FOR TOXICO-
LOGICAL RESEARCH
PINE BLUFF, ARKANSAS
Purpose and General Policy:
On January 27, 1971, President Nixon announced the establish-
ment of a National Center for Toxicological Research at Pine Bluff,
Arkansas. The Food and Drug Administration will administer the
facility in a manner that is responsive to the needs of the signatory
agencies when programs require research and development suit-
able to the Center. In addition, other Federal agencies, universities,
and industry groups will be invited to participate to the extent
that their participation appears feasible and desirable. Priority is
to be given to those programs of concern to the participating
agencies, particularly if these programs are jointly planned or
supported. An effort will be made to maintain maximum flexibility
in the operation and management of the facility to ensure respon-
siveness to the changing needs of participating agencies.
Principles of Operation:
There will be a Director of the Center with overall authority to
operate and manage the Center in accordance with policies and
priorities established by a policy board. The Director will be
appointed by the Commissioner of the Food and Drug Administra-
tion after consultation with and approval by the policy board.
The policy board will consist of government employees appointed
by the Secretary of Health, Education, and Welfare, and the
Administrator of the Environmental Protection Agency, with
provision for additional members as needed.
All members of the board must have an opportunity to express
their opinions and vote on all major decisions.
The Director will be authorized to arrange for operations of all
or any portion of the Center by contract with a suitable organiza-
-------
1368 LEGAL COMPILATION—PESTICIDES
tion, if after consultation with the policy board, such contract
operations seem desirable.
Fiscal and agency audit functions will be the responsibility of
the Food and Drug Administration.
Functions of Director:
The Director shall provide a full-time staff of one or more people
acceptable to the policy board to serve as Secretariat to the
policy board. The Director will provide managerial supervision and
facilities to this staff, but will not interfere in any way with any
instructions the Secretariat staff receives from the board. He will
assure that such staff as well as the members of the board have
full access, with his knowledge, to all activities of the Center.
Functions of Policy Board:
The policy board will meet at regular intervals, no less than six
times per year primarily at the Center, to consider and develop
policies, scientific priorities, and related program budgets and
such other matters as may affect the scientific excellence of the
Center and to assure its flexibility to serve the purposes for which
it is established. An interim board is hereby established to serve
not beyond September 30, 1971, by which time the permanent
policy board will be designated. The membership of the interim
board will consist of three voting members appointed by the
Secretary of Health, Education, and Welfare, three voting mem-
bers appointed by the Administrator of the Environmental Pro-
tection Agency, one observer from the Office of Science and
Technology, and one observer from the Council on Environmental
Quality. The six voting members shall elect a chairman from
among themselves.
The interim board will proceed immediately to develop a charter
and operating procedures to be approved by the Secretary (HEW)
and the Administrator (EPA). The charter and operating pro-
cedures will specify: the structure and membership of the board,
the procedure for appointing members (which procedure shall in
any event provide for representation in equal numbers from HEW
and EPA), a mechanism for participation of other organizations
that should participate in the policy and priority setting, a mech-
anism for obtaining scientific advice from consultants, the selec-
tion of the chairman, the frequency of meetings, the definition of
a quorum, the procedures for convening special meetings, and a
method of amending the charter and operating procedures.
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GUIDELINES AND REPORTS 1369
Matters upon which the policy board will provide advice or
guidelines to the Director include :
1. Organization of the Center
2. Qualifications and selection of key personnel
3. Overall budget requests and modifications
4. General plans and overall protocols of major projects.
5. Major building construction and modification requirements
6. Arrangements for contracts for major activities of the
Center
7. Contingencies which require experimentation and expen-
ditures of contingency funds
8. Such other matters as the Director or members of the
board considers appropriate
Protection of the scientific integrity of the laboratory is para-
mount. To this end, it should be understood that no regulatory
body will be obligated in any way to give any special weight to
results of activities of the Center or interpretation of those
results; by the same token, the board rather than individual
scientists, will be the source of any official interpretations of Cen-
ter activities desired by regulatory agencies.
As soon as possible, the interim board will recommend contracts
or other activities to the Commissioner of FDA that will facilitate
and expedite the establishment of appropriate activities of the
Center, making use of the funds being held in reserve for this
purpose.
Functions Reserved to the Commissioner of FDA :
1. Appointment of the Director of the Center after consulta-
tion with an approval by the policy board
2. Establishment of procedures to assure the legal and fiscal
responsibilities of the Center
Effective Date:
This plan of operation will become effective on the first day after
it has been signed by both the Secretary of HEW and the Admin-
istrator of EPA.
Date : Apr. 1, 1971 /g/ ELLIQT L RICHARDSON
Secretary, Health, Education and Welfare
Date : Apr. 1, 1971 /g/ WILLIAM D RUCKELSHAUS
Administrator, Environmental Protection Agency
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1370 LEGAL COMPILATION—PESTICIDES
4.1d MEMORANDUM OF AGREEMENT BETWEEN THE
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
AND THE UNITED STATES DEPARTMENT OF AGRICUL-
TURE, JUNE 14, 1972
MEMORANDUM OF AGREEMENT BETWEEN THE UNITED
STATES ENVIRONMENTAL PROTECTION AGENCY AND
THE UNITED STATES DEPARTMENT OF AGRICULTURE
I. Purpose
The purpose of this agreement is to establish policies and pro-
cedures that will provide for a continuing working relationship
between the Environmental Protection Agency (EPA) and the
Extension Service (ES), United States Department of Agriculture
(USDA) in support of programs which will encourage productive
and enjoyable harmony between man and his environment; to
promote efforts which will prevent or eliminate damage to the
environment and biosphere and stimulate the health and welfare
of man; and to enrich the understanding of the ecological system
and natural resources important to the Nation.
II. Background
The National Environmental Policy Act of 1969 directs all
Federal agencies to utilize a systematic, interdisciplinary approach
which will insure the integrated use of the natural and social
sciences and the environmental design arts in planning and
decision making which may have an impact on man's environment.
Further, the Intergovernmental Cooperation Act of 1968 specifies
that Federal agencies administering development assistance pro-
grams will consult with other affected agencies in an effort to
assure fully coordinated programs.
The Extension Service carries out educational programs related
to environmental concerns in the area of agricultural production
and marketing, natural resources development and management,
horticulture, disaster prevention and relief, and associated pollu-
tion abatement practices.
The Environmental Protection Agency has responsibility for
establishing environmental standards, monitoring and enforcing
standards, conducting research and development, and providing
training and technical assistance which are designed to improve
the quality of the environment. These involve programs dealing
with water quality, air quality, soil pollutants, radiation contami-
nation, pesticide use, solid waste and the introduction and use of
chemicals affecting human and animal health.
-------
GUIDELINES AND REPORTS 1371
III. Under terms of this agreement, the Extension Service, USDA,
will:
a. Assign appropriate staff to function in a liaison capacity with
the EPA staff in areas where mutuality of interest exists and
cooperative programs are developed.
b. Collaborate with EPA to provide through State cooperative
extension services information and education to farmers, agricul-
tural service firms and others concerning safe and effective meth-
ods of application, use and storage, and disposal of excess pesti-
cides and pesticide containers.
c. Develop and conduct education programs through and in
cooperation with the State cooperative extension services on waste
management stemming from agricultural practices, including ani-
mal, crop processing, and forest wastes, in accordance with EPA
and/or State environmental water quality standards and guidelines.
d. Develop and conduct training programs through State coop-
erative extension services and in collaboration with EPA, as
appropriate, on pesticides and other environmental improvements
relating to air, water, and soil pollution in addition to b and c
above. Keep EPA informed about training programs in these areas
conducted by State cooperative extension services.
e. Provide EPA with current information on environmental
problems concerning agriculture (including marketing and pro-
cessing) and rural communities and information from State coop-
erative extension services to assist EPA in evaluating current and
potentially new programs in areas of mutual concern.
f. Assist in negotiations of contracts and agreements, as appro-
priate, between the State cooperative extension services and EPA.
g. Encourage communication and cooperation between State
cooperative extension services and the appropriate EPA Regional
Office personnel, including the assignment of personnel to serve in
a liaison capacity.
h. Provide EPA with copies of all USDA publications and re-
leases dealing with pesticides and the environment, pesticide use,
and pesticide wastes immediately after publication.
IV. Under terms of this agreement, the Environmental Protection
Agency will:
a. Assign staff members to serve in liaison capacity with the
USDA in areas where mutuality of interest exists and cooperative
programs are developed.
b. Transmit information on changes in pesticide regulations
and registrations directly to designated leaders in State extension
services and to the ES/USDA.
-------
1372 LEGAL COMPILATION—PESTICIDES
c. Coordinate with ES/USDA in the design, development, and
support of training programs and pilot or demonstration projects
conducted on a regional or State level by participating cooperative
services.
d. Encourage communication and cooperation between EPA
Regional Office pesticide generalists and the appropriate State
cooperative extension services, including the assignment of appro-
priate staff to work with State extension personnel.
e. Work closely with the ES/USDA and State cooperative
extension services as well as other State agencies in the develop-
ment of training programs for pesticide applicators, including the
utilization of State training facilities and capabilities. Furnish the
Extension Service with copies of training and public information
materials on pesticides and the environment.
f. Provide ES/USDA with copies of all EPA publications and
releases dealing with pesticides and the environment, pesticide
use, and pesticide wastes immediately after publication.
V. This memorandum shall be implemented as follows:
a. The Environmental Protection Agency and the Department
of Agriculture each will assign a senior staff officer who will
serve in a liasion capacity.
b. Any joint endeavors involving reimbursement or transfers
of funds between the two parties will be handled in accordance
with the Economy Act and normal Government financial procedures.
Date: June 14,1972 DAyiD L DOMINIC
Assistant Administrator for Categorical Programs
U.S. ENVIRONMENTAL PROTECTION AGENCY
Date: June 14,1972 j pmL CAMpBELL
Under Secretary of Agriculture
U.S. DEPARTMENT OF AGRICULTURE
4.1e INTERAGENCY AGREEMENT BETWEEN THE U. S.
DEPARTMENT OF AGRICULTURE AND THE U. S. ENVIRON-
MENTAL PROTECTION AGENCY, Jan. 23,1973.
I. Purpose
The June 1972 decision of the Administrator, Environmental
Protection Agency (EPA), to ban the use of DDT has required
that growers look to alternative pesticides whose use may involve
a variety of hazards. This in turn requires that the users of these
materials receive special training in their safe use beyond that
-------
GUIDELINES AND REPORTS 1373
now being provided in on-going State Extension Services programs.
EPA has agreed to share the cost of the needed additional train-
ing with the Extension Services of selected States. The June 14
Memorandum of Understanding between EPA and the Extension
Service (ES), U. S. Department of Agriculture provides for
collaboration in the conduct of training activities relating to the
safe use of pesticides including those involving the State Exten-
sion Services. The purpose of this agreement is to specify the
conditions under which EPA will utilize the existing administrative
arrangements between ES and specified State Extension Services
as a means of carrying out these jointly funded training activities.
II. Scope of Work
The work to be performed by the ES will include the following:
1. Reviewing patterns of pesticides usage in all 50 States so
as to determine those states in which additional training
is required in the safe use of replacement pesticides. This
phase of the work has been completed and has resulted in
the identification of Virginia, South Carolina, North Caro-
lina, Georgia, Florida, Tennessee, Kentucky, Alabama, Mis-
sissippi, Arkansas, Texas, Louisiana, Oklahoma, and
Missouri as requiring training programs beyond those now
provided by on-going efforts of the Extension Services of
those states.
2. Obtaining proposals from the Extension Services of each
of the states listed above which outlines a plan for provid-
ing the additional training needed by that state. While
these plans may vary according to the specific problems and
capabilities of the individual states, they should include
(1) Numerical description of the problem; i.e., number of
individuals who might be poisoned absent a new fed-
erally funded program.
(2) Brief description of expected problems in implement-
ing proposed program.
(3) A detailed plan of events schedule.
(4) Proposed method of regular monthly activity report-
ing and evaluation of effectiveness.
3. Participating with EPA representatives in the review of
proposed State plans to determine if the plans represent a
satisfactory basis for the conduct of a jointly funded
training program.
4. Utilizing existing ES administrative arrangements with
State Extension Services as a means for entering into
-------
1374 LEGAL COMPILATION—PESTICIDES
contracts with the above states for the conduct of training
programs based upon State proposals.
5. Providing technical and administrative direction of the
work performed under each of these contracts.
6. Participating with EPA in evaluating the effectiveness of
the training activities in each State.
III. Provisions
The following special provisions are applicable to the perform-
ance of work under this agreement:
1. Contractual arrangements with the State Extension Ser-
vices will provide for a sharing of cost in ratio of 750/1100
Federal funds to 350/1100 State funds.
2. The total funds to be transferred from EPA to USDA in
support of this joint program are $750,000. The transfer
of funds from the USDA to the individual State Extension
Services will be on a 40-40-20 basis; i.e., 40 percent as the
State plan is approved, an additional percent will be released
midway through the project (April 1, 1973), and the final
20 percent prior to the completion of the program (June 1,
1973); the second and third allocations will be made subse-
quent to on-going review and final approval of the indi-
vidual continuing State programs by EPA Regional Pro-
ject Managers.
3. Each proposed State plan must have the written approval
of both the EPA and ES Project Officers before it is used
as a basis for entering into a contract.
4. EPA Regional Office staffs will participate directly with the
State Extension Services in the development of mutually
acceptable proposed State plans. Regional Office staffs will
carry out close liaison with the individual State Extension
Services so as to coordinate the work accomplished under
these contracts with direct EPA efforts in the area of
pesticide safety.
5. Contracts with individual State Extension Services will
include requirements for the submission of the reports
listed in Section IV directly to EPA and ES Project Officers.
IV. Duration of Agreement
This agreement will cover the period through June 1, 1973, or
until completion of the work whichever occurs first.
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GUIDELINES AND REPORTS 1375
V. Reports
A monthly report will be submitted by each State Extension
Service to the EPA Regional Project Managers which will:
1. Compare actual expenditures by line item with those pro-
jected in the approved State plan.
2. Indicate the number of safety aides hired and the number
of safety aides receiving training.
3. A description of the actual training provided to members
of the target audience specifying the type of training and
the number of persons receiving training.
4. The results of statistically valid sample audits of training
activity as agreed upon by EPA and USDA/ES.
VI. Project Officers
Mr. Paul Pendorf, Room 1037, 401 M St., S.W., Washington,
D. C. (202-755-0320) will serve as Project Officer for EPA; Dr.
L. C. Gibbs, Room 5513, South Agriculture Building, 14th and
Independence Ave., S.W., Washington, D. C. (202-447-4481) will
serve as Project Officer for ES.
VII. Funding
EPA will transfer $750,000 to ES to cover EPA's share of the
costs under the contracts entered into by ES pursuant to this
agreement. This amount is to be allocated to individual State
Extension Services in accordance with the provisions of clause
111(2) above and the State by State distribution of funds as set
forth in Attachment A. Any of this foregoing amount remaining
unexpended after the completion of the work under these contracts
shall be returned to EPA.
Upon execution of this agreement an allocation transfer will be
made from EPA to the ES, by Standard Form 1151, "Non-
Expenditure Transfer Authorization." Funds will be withdrawn
from Office of Pesticides Program Sub-Element No. PE 2E5367-32
for this purpose.
VIII. Termination and Amendment
In case the ban on the use of DDT is lifted by court action, the
program may be stopped at a mutually agreed date and unused
funds returned. The program may be extended indefinitely if
mutually agreed to.
-------
1376 LEGAL COMPILATION — PESTICIDES
IX. Authority
This agreement is entered into pursuant to Section 23 (c) of
Federal Environmental Pesticides Control Act of 1972, PL 92-516.
Date Jan. 23, 1973
DQMINICK
Assistant Administrator for Categorical Programs
U. S. ENVIRONMENTAL PROTECTION AGENCY
Date Feb. 3, 1973 , , T _„„ „ . ,,T,T,T,T T
/s/ J. PHIL CAMPBELL
Under Secretary of Agriculture
U.S. DEPARTMENT OF AGRICULTURE
State ATTACHMENT A Funding
Alabama .......................................... $ 86,500
Arkansas ......................................... 38,475
Florida ........................................... 13,650
Georgia ........................................... 63,400
Kentucky ......................................... 3,825
Louisiana ......................................... 25,425
Mississippi ........................................ 82,050
Missouri .......................................... 37,050
North Carolina .................................... 173,100
Oklahoma ......................................... 27,825
South Carolina .................................... 56,025
Tennessee ......................................... 86,500
Texas ............................................ 36,150
Virginia .......................................... 20,025
$750,000
4.2 SELECTED REPORTS
4.2a THE PRESIDENTS SCIENCE ADVISORY COMMITTEE
REPORT ON PESTICIDES, MAY 14, 1963
I. INTRODUCTION
Man's primary concerns have always been the struggle for sur-
vival and improvement of his lot. As his numbers increased, he
attained greater ability to manipulate his environment. In the proc-
ess he sometimes inflicted damage on himself and on his sur-
roundings. Advances have always entailed a degree of risk which
society must weigh and either accept, or reject, as the price of
material progress.
A major step in civilization was the domestication of food
plants. With the birth of organized agriculture and the resultant
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GUIDELINES AND REPORTS 1377
concentration of crops and animals, the stage was set for out-
breaks of pests. Until that time man had to search for food as did
the pests. Afterwards neither had to search; instead pest control
became necessary. The welfare of an increasing human population
requires intensified agriculture. This in turn enables the pests to
increase, which necessitates the use of pesticides with their con-
comitant hazards. It thus seems inevitable that, as the population
increases, so do certain hazards.
In an effort to understand and evaluate these problems, the
Panel undertook a review of the information relevant to pesticides,
including experimental data and the various administrative proce-
dures which are designed for the protection of the public. The
Panel could not have accomplished this review without the assist-
ance it received from the Departments of Agriculture, Interior,
Defense, and Health, Education and Welfare, as well as from many
individuals throughout the country.
The information provided to the Panel has demonstrated how
remarkably effective the modern organic chemicals are in facili-
tating both the control of insect vectors of disease and the unpre-
cedented production of food, feed and fiber. The use of pesticides
associated with the production of our food is carefully controlled
by the growers and supervised by agricultural specialists and the
Food and Drug Administration. As a result, the residue levels
measured on foods intended for interstate and foreign commerce
are low and rarely above federal tolerance limits.
The Panel believes that the use of pesticides must be continued
if we are to maintain the advantages now resulting from the work
of informed food producers and those responsible for control of
disease. On the other hand, it has now become clear that the prop-
er usage is not simple and that, while they destroy harmful insects
and plants, pesticides may also be toxic to beneficial plants and
animals, including man. Their toxic effects in large doses are well
known and precautions can be taken to see that humans are never
needlessly exposed. But we must now also take measures to ensure
that continued exposures to small amounts of these chemicals in
our environment will not be harmful over long periods of time.
Review of pesticides brings into focus their great merits while
suggesting that there are apparent risks. This is the nature of the
dilemma that confronts the nation. The Panel has attempted to
state the case—the benefits, the hazards and the methods of con-
trolling the hazards. It can suggest ways of avoiding or lessening
the hazards, but in the end society must decide, and to do so it
must obtain adequate information on which to base its judgments.
-------
1378 LEGAL COMPILATION—PESTICIDES
The decision is an uncomfortable one which can never be final but
must be constantly in flux as circumstances change and knowledge
increases. r ,,
[p. 1]
II. GAINS FROM THE USE OP PESTICIDES
Our material standard of living has been greatly elevated dur-
ing the twentieth century by increased control over the environ-
ment. Few recent developments have been so effective or have had
application in such a wide range of human endeavor as the pesti-
cide chemicals. Although pesticides have been used for centuries as
adjuncts in pest control, the great advances of the last 20 years
resulting from the discovery, manufacture and application of new
compounds have changed their role in many instances to that of
the principal and frequently sole control measure.
Pesticides have made a great impact by facilitating the produc-
tion and protection of food, feed and fibre in greater quantity and
quality; by improving health; and by keeping in check many kinds
of nuisance insects and unwanted plants. Agricultural needs have
entailed the largest applications of pesticides in this country. Pro-
ductivity has been so increased that famine is an unknown expe-
rience to the people of the developed nations. Mechanization,
improved fertilizers, and the breeding of productive and disease-
resistant crops have also contributed importantly. In addition, pes-
ticides have made possible the economical production of many
crops which otherwise would be available only to a limited number
of wealthy consumers.
While reducing food losses, pest control has also resulted in
foodstuffs of the highest quality. Today, for example, sweet corn,
potatoes, cabbage, apples and tomatoes are all available unmarred,
and the American housewife is accustomed to blemish-free prod-
ucts. Citrus fruits are seldom damaged or lost because of scale
insects, fruit flies or diseases, and the cost of animal protein is
lower because large losses of cattle from tick fever and grubs no
longer occur.
Modern agricultural efficiency is maintained not only through
the use of insecticides, but also by means of herbicides, fungicides,
rodenticides, nematocides, plant growth regulators and other
chemicals. Their benefits extend beyond crops raised for direct
human consumption. They permit efficient production of forage
and grains, which in turn are needed for a productive livestock
economy. In addition, they allow profitable yields of non-food
crops such as cotton, tobacco and timber. Pesticides have not, how-
ever, reached an optimum of effectiveness. More than 100 estab-
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GUIDELINES AND REPORTS 1379
lished pests have developed resistance to one or more previously
effective chemicals, and new pests are occasionally introduced by
international traffic.
Rapid population growth and concomitant decrease in land avail-
able for agriculture necessitate greater crop yields per acre and
reduction of losses and spoilage in stored foods. Moreover, many
products must be protected during the process of manufacture and
distribution.
Besides enabling spectacular increases in agricultural produc-
tion, pesticides have freed man from communicable diseases to an
unprecedented extent. In less developed areas of the world, ma-
laria, typhus and yellow fever, previously controlled only with
great difficulty, are now limited and in some locations eradicated.
In each case, pesticides have facilitated control of the insect vector.
At some stage of their natural history a number of the major
communicable diseases involve an intermediate host or vector.
Most successful r „-,
disease control programs have been directed at eliminating this
link in the chain of transmission, rather than treating man after
he has contracted the disease.
However, control programs have not achieved disease eradica-
tion. Malaria is still the disease responsible for the largest num-
ber of deaths in the world each year, although new cases are rare
in the United States. Yellow fever, schistosomiasis, plague and
some rickettsial diseases are almost unknown in the mainland of
North America, but they still take a large toll of human lives in
the rest of the world. Furthermore, reservoirs of disease in ani-
mals, and insects which can transmit them, will remain with us
for the predictable future both in this country and in other parts
of the world thus requiring a continued effort to control them.
An additional complication in disease control is that the insect
vectors, such as mosquitoes that transmit malaria, may produce
resistant populations capable of transmitting the resistance to
pesticides from generation to generation. In order to keep up with
the successive threats of insect vectors as they develop resistance
to one chemical after another, it is important to enlarge and im-
prove our capability for controlling pests.
Pesticides also have made control of many nuisance insects and
plants financially feasible. Were the costs higher, the funds for their
control would be used by other more critical demands on the econ-
omy. For example, it might be too expensive to control the varieties
of mosquitoes that breed in marshes and estuaries which do not
transmit disease, but limit man's enjoyment of some of the most
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1380 LEGAL COMPILATION—PESTICIDES
desirable recreational areas. Similarly, elimination of roaches from
kitchens, aphids from roses and fungi from golf greens are very
desirable but nonessential benefits.
Efficient agricultural production, protection of health and elim-
ination of nuisances are now required and expected by modern man.
The methods used to accomplish these ends must continue to im-
prove, although their present scope and magnitude far exceed the
few examples included here. It is certain that coming years will
witness sophistication of methods and new uses for which pesticides
were not originally conceived.
III. THE HAZARDS OP USING PESTICIDES
Evidence of increasing environmental contamination by pesticide
chemicals has generated concern which is no longer limited to citi-
zens of affected areas or members of special interest groups. During
two decades of intensive technical and industrial advancement we
have dispersed a huge volume of synthetic compounds, both inten-
tionally and inadvertently. Many, such as detergents, industrial
wastes and pesticides are now found far from the point of initial
dispersal.
Today, pesticides are detectable in many food items, in some
clothing, in man and animals, and in various parts of our natural
surroundings. Carried from one locality to another by air currents,
water runoff, or living organisms (either directly or indirectly
through extended food chains), pesticides have travelled great dis-
tances and some of them have persisted for long periods of
[p. 3]
time. Although they remain in small quantities, their variety,
toxicity and persistence are affecting biological systems in nature
and may eventually affect human health. The benefits of these
substances are apparent. We are now beginning to evaluate some
of their less obvious effects and potential risks.
Precisely because pesticide chemicals are designed to kill or
metabolically upset some living target organism, they are potentially
dangerous to other living organisms. Most of them are highly toxic
in concentrated amounts, and in unfortunate instances they have
caused illness and death of people and wildlife. Although acute
human poisoning is a measurable and, in some cases, a significant
hazard, it is relatively easy to identify and control by comparison
with potential, low-level chronic toxicity which has been observed in
experimental animals.
The Panel is convinced that we must understand more completely
the properties of these chemicals and determine their long-term
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GUIDELINES AND REPORTS 1381
impact on biological systems including man. The Panel's recommen-
dations are directed toward these needs, and toward more judicious
use of pesticides or alternate methods of pest control, in an effort
to minimize risks and maximize gains. They are offered with the
full recognition that pesticides constitute only one facet of the
general problem of environmental pollution, but with the conviction
that the hazards resulting from their use dictate rapid strengthen-
ing of interim measures until such time as we have realized a com-
prehensive program for controlling environmental pollution.
A. CLASSES OF COMPOUNDS
The term pesticide broadly includes compounds intended for a
variety of purposes. They are used to control insects, mites, ticks,
fungi, nematodes, rodents, pest birds, predatory animals, rough
fish, plant diseases and weeds; and also to act as regulators of plant
growth, as defoliants, and as desiccants. As of June, 1962, almost
500 compounds incorporated in more than 54,000 formulations were
registered for use in the United States.
1. The chlorinated hydrocarbons containing carbon, hydrogen,
and chlorine are the pesticides used in greatest tonnage. The most
familiar are DDT, dieldrin, aldrin, endrin, toxaphene, lindane,
methoxychlor, chlordane, and heptachlor. Among those used exten-
sively as herbicides are 2,4-D and 2,4,5-T for control of broad-
leaved weeds in lawns, pastures, cereal crops, and brush growth
along highways and fences.
2. The organic phosphorus compounds, composed of phosphorus,
oxygen, carbon and hydrogen, are used principally as insecticides
and miticides. Parathion, malathion, phosdrin and tetraethyl pyro-
phosphate (TEPP) are examples.
3. Other organic compounds include the carbamates, dinitrophe-
nols, organic sulfur compounds, organic mercurials, and such
natural products as rotenone, pyrethrum, nicotine, strychnine and
the anticoagulant rodent poisons.
4. Inorganic substances with a long history of use include copper
sulfate, arsenate of lead, calcium arsenate, compounds of chlorine
and fluorine, zinc phosphide, thallium sulfate and sodium fluoro-
acetate. r ...
[p. 4]
B. DISTRIBUTION AND PERSISTENCE IN THE ENVIRONMENT
The world-wide use of pesticides has substantially increased since
the development of DDT and other chlorinated hydrocarbons in the
early 1940's. United States production and use are illustrated in
figures 1 and 2. It is estimated that 350 million pounds of insecti-
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1382 LEGAL COMPILATION—PESTICIDES
cides alone were used in the United States during 1962. They are
distributed annually over nearly 90 million acres (about 1 acre out
of 20 within the 48 contiguous states). These acreages are composed
of farmlands, forests and insect breeding areas, including wetlands.
Weed killers are distributed on approximately the same number of
acres, with some overlap of areas covered by insecticides. Thus the
land area treated with pesticides is approximately 1 acre of 12
within the 48 states. About 45 million pounds are used each year in
urban areas and around homes, much of this by individual home
owners. The annual sale of aerosol "bug bombs" amounts to more
than one per household. Other compounds, such as fungicides, also
are used in substantial tonnage.
In recent years we have recognized the wide distribution and
persistence of DDT. It has been detected at great distances from
the place of application and its concentration in certain living orga-
nisms has been observed. DDT has been found in oil of fish that live
far at sea and in fish caught off the coasts of eastern and western
North America, South America, Europe and Asia. Observed con-
centrations have varied from less than 1 part per million (ppm) to
more than 300 ppm in oil.
Residues of DDT and certain other chlorinated hydrocarbons
have been detected in most of our major rivers, in ground water, in
fish from our fresh waters, in migratory birds, in wild mammals and
in shellfish. Small amounts of DDT have been detected in food from
many parts of the world, including processed dairy products from
the United States, Europe, and South America. The amounts are
rarely above Food and Drug Administration (FDA) tolerance limits
but these have probably contributed to the buildup of DDT we now
observe in the fat of the people of the United States, Canada, Ger-
many and England. In the United States, DDT and its metabolites
have been found in the fat of persons without occupational exposure
at an average of 12 ppm (approximately 100 to 200 mg. of DDT per
adult) for the past 10 years. In England and Germany, recent
studies revealed an average concentration of 2 ppm in human fat.
Data about children are not available.
An important characteristic of several commonly used pesticides
is their persistence in the environment in toxic form. The chemical
half-life of stable chlorinated hydrocarbons in soils, and the time
they remain active against some soil insects are measured in years.
The organic phosphorus compounds are more rapidly degraded al-
though, under certain circumstances, they have persisted from one
growing season to the next following routine application. Pyre-
thrum, rotenone, and nicotine are destroyed relatively rapidly after
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GUIDELINES AND REPORTS 1383
application, but compounds incorporating copper, lead, and arsenic
are persistent.
The distribution and persistence of other chlorinated hydrocar-
bons have been studies in less detail, although some of these chem-
icals have been widely applied. One of these, dieldrin, resembles DDT
in stability, persistence, and in solubility. Recently, it has been
found in the fat of residents of r 51
southern England. It has also been found in many wild birds, fish
and mammals in the United States. These facts led the Panel to
anticipate that surveys will discover dieldrin and other persistent
chlorinated hydrocarbons in man and wildlife throughout most of
the United States.
C. BIOLOGICAL EFFECTS ON MAN AND ANIMALS
1. Exposure of man
The extent of hazard associated with use of a pesticide is deter-
mined by the degree of exposure and the compound's toxicity. Ex-
posure depends on persistence, the amount applied, the method of
application, and availability of the chemical in a biologically active
form. Pesticides can enter the body by (a) ingestion, (b) absorption
through the intact skin, and (c) inhalation.
(a) When examining the potential hazards to man from extensive
use of pesticides, an early consideration should be the possible effects
of chemical residues in the nation's food supply. The Panel has
received evidence that, before pesticides are recommended for reg-
istration, considerable research has been performed on the extent
and nature of their residues on foods, and that safeguards exist
which can permit pesticide usage without danger to the consumer.
These include proper controls over manufacture, commercial dis-
tribution, and techniques of pesticide application to crops; strict
establishment of tolerance limitations; inspection for residues in
produce; and other precautions. When measured in foods entering
interstate or foreign commerce, and in total diet studies, residue
levels have been very low and rarely above the legal tolerance limits.
If illegal residues are found, the foods containing them are removed
from the market.
Residues are not so consistently low for food items marketed
within their state of origin. Some state authorities sample food for
pesticide residues. Data from certain states have shown residues
well above the Federal tolerance on 3 percent of the fresh fruits and
vegetables offered for sale in wholesale markets. Many states do not
perform systematic sampling for residues in the produce and dairy
products intended for consumption within the state.
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1384 LEGAL COMPILATION—PESTICIDES
Residues of several chlorinated hydrocarbons have been meas-
ured in game birds and game fish at levels above Federal tolerance
limits. Because few wildlife meals are consumed, this is not an
important source for residue accumulation in man. By contrast,
household use of pesticides with inadvertent contamination of
dishes, utensils, or food may well produce more significant residues
in man.
(b) Most insecticides are readily absorbed through the intact
skin. Skin contamination can be an important source of exposure
for persons who mishandle pesticides in their formulation or com-
mercial application. Furthermore, since householders usually take
few precautions in their home and garden uses of these chemicals,
they may receive extensive skin contact both from successive appli-
cations and from continuing exposure to residues.
The rate of absorption through the skin depends on the chemical
nature of the pesticide and on its formulation. In general, compounds
in solution in oils or in organic solvents are absorbed more readily
than those
[p. 6]
in aqueous preparations or in dry powder. Skin absorption can
occur from pesticide aerosols, from dusts, from clothing or blank-
ets impregnated with chlorinated hydrocarbons and from con-
taminated soil or lawn grass.
The rates of skin absorption have not been adequately studied in
man. It is particularly important to determine the rates at which
mothproofing insecticides are absorbed through human skin in con-
tact with impregnated clothing or blankets. Such impregnation is
performed during the manufacture of mothproofed garments and
materials, and routinely during drycleaning. Many of these articles,
such as sweaters and blankets, may be in direct contact with the
skin for prolonged periods. Clearly, studies are needed to understand
possible sensitization and allergic responses.
(c) Man's exposure to pesticides can also occur through inhala-
tion. Airborne insecticides are sources of exposure when released
during fogging operations directed against nuisance insects in pub-
lic areas, buildings, and homes. Pesticides may be inhaled in dusts
from treated soil, from house dusts contaminated by applications
for household pests, or from mothproofed rugs and blankets.
2. Effects on Man
There have been few systematic studies of people occupationally
exposed to pesticides. In one such investigation, a small group of
volunteers with an intake up to 35 mg. of DDT per day over a period
of months was reported to show no apparent ill effects during 18
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GUIDELINES AND REPORTS 1385
months of gross observation. DDT and its metabolites averaged 270
ppm in their fat, more than 20 times the average level found in
adults sampled in this country. Limited groups of adults occupa-
tionally exposed to the more toxic pesticides are also being studied,
and there is evidence of neurologic impairment, usually reversible,
in those individuals heavily exposed to certain chlorinated hydro-
carbons and organic phosphates. Unfortunately, possible long term
effects of other compounds cannot be predicted on the basis of ex-
perience with DDT, or even predicted for DDT itself, on the basis
of the limited clinical studies available.
Accidental acute poisoning in man has been caused by about 50
pesticides, including at least one compound from each major class.
Each year, approximately 150 deaths are attributed to misuse of
pesticides in the United States. About half of these occur in children
who were accidentally exposed at home. The number of non-fatal
poisonings can only be estimated. A Special Committee on Public
Policy Regarding Agricultural Chemicals, appointed by Governor
Edmund G. Brown on June 15, 1960, reported that in California,
which uses 20 % of the nationally consumed pesticides, 3,000 children
per year ingest various amounts of these compounds. In that state
during 1959 there were also 1,100 cases of occupational disease due
to agricultural chemicals, mostly among agricultural workers. These
figures include acute illnesses, whether the reaction was very mild,
or severe enough to require hospitalization. One difficulty in esti-
mating the incidence of poisoning is that the symptoms caused by
pesticide toxicity are little different from those of many common
illnesses.
Little is known about the consequences to man when he accumu-
lates more than one pesticide in his body. Synergism, or potentia-
tion, is the joint action of two agents which results in an effect which
is greater than the sum r ,
of their individual effects. Some combinations of two organic
phosphates have produced effects ten times those observed when
either compound was fed separately. Preliminary FDA data show
only additive effects from mixtures of chlorinated hydrocarbons
included in diets of experimental animals.
Physicians are generally unaware of the wide distribution of
pesticides, their toxicity and their possible effects on human health.
Diagnosis of pesticide toxicity is apparent when a patient with acute
asthma has to be resuscitated in the middle of the night following
exposure to commercial fogging. However, diagnosis is difficult in
patients with nonspecific symptoms that may result from unsus-
pected contamination with pesticides. The Panel was unable to find
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1386 LEGAL COMPILATION—PESTICIDES
any Federally sponsored research in this area of potential medical
importance.
3. Effects on Wildlife
Many kinds of insect control programs have produced substantial
mortalities among birds and other wildlife. Some fatalities have
been the result of carelessness or nondirected use; others have fol-
lowed programs carried out exactly as planned. Mortalities among
birds have approached 80 percent in areas heavily treated with DDT
for Dutch Elm Disease control, with heptachlor for imported fire
ant control and with aldrin or dieldrin for controlling the Japanese
Beetle. Fish losses have been extensive even with lower rates of
application in programs such as spruce budworm control using
DDT. Losses following agricultural operations are more scattered
and less well documented.
Most insecticides are toxic to a wide range of animals and certain
classes are consistently more susceptible than others. Insecticides
tend to be more toxic to invertebrates than vertebrates, because the
target insects are more closely related to other invertebrates. For
example, pink shrimp have been experimentally poisoned by 0.9
parts per billion of heptachlor. Other marine organisms are also
highly sensitive. The growth of young oysters has been inhibited
by concentrations as low as 3 parts per 100 million of chlordane,
heptachlor, or rotenone. Five other commonly used pesticides in-
hibit oyster growth in concentrations of 1 part per 10 million.
An entire year's production of young salmon was nearly elimi-
nated in the Miramichi River in New Brunswick in 1954, and again
in 1956. This resulted from DDT applications of one-half pound per
acre for control of the spruce budworm. Stream insects, which are
a most important food for young salmon, disappeared and failed
to return within 2 years. Surviving young salmon were very thin.
In British Columbia, mortality of coho salmon approached 100
percent in at least four major streams after the surrounding for-
ests were sprayed with 1 pound of DDT per acre for control of the
blackheaded budworm. This mortality occurred despite preventive
measures to avoid treating the streams themselves.
Among vertebrates, fish are generally more sensitive than birds,
and birds are more sensitive than mammals. Reptiles and amphib-
ians vary greatly from species to species, but their susceptibilities
usually fall between those of fish and birds. Variations in sensi-
tivity may result in the elimination of certain forms from the food
chain. While some organisms may be decimated, resistant orga-
nisms which survive exposure may concentrate and
[p. 8]
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GUIDELINES AND REPORTS 1387
store pesticides at levels higher than those found in the environ-
ment. Such biological magnification on the part of resistant
species may ultimately damage more sensitive organisms which
are higher in the food chain. At Clear Lake, California, for example,
waters containing 0.02 ppm of TDE produced plankton containing
5 ppm, which in turn produced fish with fat containing hundreds
to thousands of parts per million. Grebes that fed on the fish
died although their fat contained somewhat smaller residues than
the fish.
Robin populations declined drastically after Dutch elm disease
spraying in certain communities in Wisconsin and Michigan.
Earthworms, resistant to DDT, fed on fallen elm leaves and accu-
mulated substantial amounts of the pesticide. Robins, for whom
worms are a principal food, fed on the worms and died.
The process of biological magnification has less impact on man
because human food is produced by a two or three link chain in
which the process, if recognized, can be controlled. For example,
residues are permitted on feeds for domestic animals only in
amounts that will not ultimately yield unacceptable levels in meat,
in milk, or in other animal products. Thus, excessive levels of pesti-
cide residues in agricultural products used for human food result
only from accident or misuse, while damaging levels in the food of
wild animals may be unwanted effects resulting from recommended
practices. When contaminated fish and shellfish are harvested com-
mercially, any residues they may contain are of concern to the
fisherman and the consumer. Yet the commercial fisherman cannot
control the sources of such contamination.
Wild animal populations are affected differently by pesticides
residues than are domestic animals and man. Unlike the latter,
wild animals cannot be kept from treated areas long enough for
the chemical residues to degrade or otherwise dissipate. Because
birds and mammals are free to range over relatively large areas,
they are exposed to a variety of different compounds. Insectivorous
birds are likely to be attracted to areas which dense insect popula-
tions, and may be exposed when chemicals are applied. Further-
more, birds reoccupy a depleted area very rapidly; thus a treated
area may constitute a trap into which successive waves of birds
move and are killed. Fish in streams are generally less mobile than
birds and mammals, but they, too, may be subject to multiple
exposure to pesticides. Flowing waters contaminated by accidental
drifts or run-offs can affect the fish even though they do not move
into treated areas.
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1388 LEGAL COMPILATION—PESTICIDES
D. TOXICITY OF SPECIFIC COMPOUNDS
1. Chlorinated Hydrocarbons
In very small doses (some cases less than 1 ppm) chlorinated
hydrocarbons have caused liver damage to experimental animals,
and in large doses they have caused acute central nervous system
effects, occasionally followed by death. The mechanisms leading to
these effects are unknown.
The biological effects of DDT have been studied more fully than
those of other pesticides. Its toxicity to man and other mammals
is low. People ingesting large amounts of DDT usually suffer no
apparent ill effects. In chronic feeding experiments with rats, 5
ppm produced characteristic
[p. 9]
chlorinated hydrocarbon changes in the liver, but no evidence of
tumor induction. Reproduction studies in rats showed that 50 ppm
reduced the number of young that survived the nursing period.
There was no effect on reproduction at 10 ppm. However, many
useful insects and other valuable invertebrates such as shrimp,
crayfish, and crabs are highly susceptible to DDT. Decimation of
these useful populations may be a costly side effect of extensive
applications.
Dieldrin and aldrin are many times more toxic to vertebrates
than DDT. Since aldrin is converted to dieldrin in man and in the
environment, a discussion of dieldrin applies to both.
Dieldrin is present in the body fat of residents of England (aver-
age 0.2 ppm) and is probably also present in the fat of the U.S.
population as a result of extensive applications of the chemical in
this country. There have been many cases of acute poisoning in
people exposed to dieldrin in their work. Signs of intoxication in-
volve the central nervous system, and may include electroencephalo-
graphic changes, muscle tremors and convulsions. Individuals have
suffered recurrences of these symptoms after they have been free
of them for more than a month following their last exposure.
Our knowledge of toxicity at lower doses comes chiefly from
FDA feeding experiments in which mice were fed varying concen-
trations of dieldrin and aldrin in their diet. Chronic exposure to as
little as 0.5 ppm produced histological liver damage while increase
to 10 ppm caused a four fold increase in the frequency of liver
tumors. There are virtually no data on the effects on embryonic
development. In one of the few experiments known to the Panel,
the feeding of dieldrin (at 0.6 mg/kg of body weight) to several
pregnant dogs resulted in 100 percent mortality of 14 nursing
puppies. The mothers were fed the pesticide during pregnancy
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GUIDELINES AND REPORTS 1389
but none during lactation. In another study, rats fed dieldrin at
2.5 ppm in the diet showed a significant reduction in number of
pregnancies and an increased mortality in suckling young.
Although most insecticides do not kill wild mammals in the
field even when they kill birds and fish, 1 to 3 Ibs. per acre of
dieldrin or aldrin produces high mortality among mammals in the
treated areas. Dieldrin is also highly toxic to many birds, amphibia,
reptiles, and fish. It reduces the reproduction of captive quail by
decreasing egg production, decreasing the percentage of eggs that
hatch, and increasing the mortality of chicks. Many beneficial and
useful invertebrates are very susceptible.
Other chlorinated hydrocarbons in common use have shown
marked acute toxicity to rats in feeding experiments. Chronic
effects have been noted with chlordane and heptachlor at the low-
est level fed to experimental animals. Chlordane at 2.5 ppm pro-
duced liver damage and 0.5 ppm of heptachlor epoxide produced
liver damage and increased mortality in the laboratory mice. Field
use also suggests high toxicity to birds and mammals. Although
these substances are used in large quantities there have been no
studies to determine whether they accumulate in the human popula-
tion, nor are there adequate studies of their genetic, tumorigenic,
teratogenic or reproductive effects in mammals or birds.
[p. 10]
2. Organic Phosphorus Compounds
Among their effects, the organic phosphorus compounds inhibit
cholinesterase activity and thereby interfere with transmission of
impulses from nerve to ganglion and nerve to muscle.
Most organic phosphorus insecticides have relatively high acute
toxicities and have caused many fatal and nonfatal poisonings in
man. In cases of poisoning, removal from exposure to the compound
usually permits rapid recovery. Many of them are degraded rapidly
and thus seldom persist in the environment but some, such as
parathion, have persisted for months in soils and have recently
been found in trace amounts in water drawn from deep wells.
[p. HI
IV. PEST CONTROL WITHOUT CHEMICALS
Methods for controlling pests without the use of pesticides were
known to farmers even in ancient times. Crops were planted in
areas least liable to pest damage; crops were moved to virgin terri-
tory to leave the pests behind; rotation was practiced and crops
that were less prone to disease were planted; if the pests came late
in the season, crops were planted early, and vice versa. Many of
these methods are used today.
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1390 LEGAL COMPILATION—PESTICIDES
The environment can also be modified indirectly; for example
we use screens on windows to keep out mosquitoes, and flood or
drain marshes to destroy their breeding areas. In certain cases
parasites, predators and diseases control the pests without chemi-
cals. In the United States and many other countries of the world
parasites and predators have been successfully introduced to com-
bat scale insects on citrus fruits, apples and sugar cane; and in
Australia the myxomatosis virus was introduced to kill rabbits.
Entomologists have long been interested in the use of insect
enemies for pest control. The United States Department of Agri-
culture has been active in this area since 1888. It has imported
more than 500 species of insect destroying organisms, of which
about 36 have had partial or complete success. Introduced insects
have succeeded in controlling cactus in Australia and Klamath
weed in the western United States. However, biological methods
of insect control have received relatively little attention in the
United States by comparison with the great emphasis on chemical
control.
An effective method of biological control is the discovery or
breeding of resistant varieties of crops. This method has worked
best for plant diseases, and several varieties of wheat which are
resistant to rust have been bred in this country. Another example
of the use of plant resistance was provided by the grafting of
French wine grapes to resistant American rootstocks when the
French grapes were severely damaged by the root insect Phylloxera
in the middle of the last century.
Other examples of effective biological control can be cited, but
success has not been frequent. Continued and extensive searches
will undoubtedly yield more, and the Panel believes this approach
should be expanded.
Although non-chemical methods for pest control are intriguing
they also have weaknesses. Two are particularly important. In the
first place, parasites and predators have adjusted over the millenia
to a dynamic balance with their hosts such that they kill some but
not all of them; complete host destruction would eliminate the
parasite or predator by destroying its food supply. Thus, control
of the pest is seldom complete enough to prevent economic damage.
Furthermore, reduction of the pest population is rarely sufficient to
prevent its becoming dense again. A second limitation to the use of
natural enemies is that the host may become resistant, just as it
may develop resistance to chemical controls.
Australian rabbits for example, are becoming resistant to myx-
omatosis, and their populations once again are on the increase.
[P. 12]
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GUIDELINES AND REPORTS 1391
A new method of biological control is the laboratory production
of sterile male insects in very large numbers, using either gamma
rays or specific chemical sterilants. The males are then liberated
into the natural population where their matings produce infertile
eggs. Although this procedure eliminated the screw worm fly in
Florida, it has not yet been investigated extensively for controlling
other insects.
A still newer method is the use of sex attractants to lure male
insects into traps and thus their death. With certain species this
technique has great promise and developmental research is being
expanded.
The variety of methods that has proven useful for biological
control of certain pests, and the indication of potential value for
others lead to the conclusion that more active exploration and use
of these techniques may yield important benefits for the national
economy and for the protection of health.
[p. 13]
V. THE ROLE OF GOVERNMENT IN PESTICIDE REGULATION
A. MECHANISMS FOR REGULATION
Public interest in the protection of the nation's health and its
resources has led to the enactment of legislation and the establish-
ment of administrative procedures to regulate the marketing and
use of pesticides. The Public Health Service has general responsi-
bilities for the health of man and the Fish and Wildlife Service for
the protection of wild animals. In addition, two fundamental laws,
the Federal Insecticide, Fungicide, and Rodenticide Act, and the
Food, Drug, and Cosmetic Act, assign responsibility for pesticide
control to the U. S. Department of Agriculture (USDA) and re-
sponsibility for the safety of foods containing pesticide residues
to the Department of Health, Education and Welfare (HEW). The
Secretary has delegated this responsibility to the Food and Drug
Administration (FDA).
When a new pesticide is developed in an industrial laboratory an
application is submitted to USDA requesting that it be registered
for use. If the proposed use does not include application on a food
crop, USDA reviews the experimental data submitted with the
application. The compound is registered for use if it is concluded
that no undue hazard to man and domestic animals is associated
with the proposed use when applied according to the instructions
on the label.
When a pesticide is proposed for use on food crops, the applica-
tion for registration must list each crop on which it is to be applied
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1392 LEGAL COMPILATION—PESTICIDES
and must present the necessary data on effectiveness and toxicity.
If it can be demonstrated to USDA that the produce leaves no
residue on a particular crop when used in the proposed manner,
the specific pesticidal formulation covered by the application is
registered for use on that crop on a "no residue" basis. The product
may then be legally shipped in Interstate Commerce. If, however,
the compound leaves a residue, USDA delays registration until a
residue tolerance has been established by FDA.
To initiate this procedure, the manufacturer files a petition for
tolerance with FDA. The USDA then certifies to FDA that the
product under consideration is useful and offers an opinion on
whether the petitioner's proposed tolerance reasonably reflects the
residues to be expected from its use according to directions. Until
1955, tolerances were established by FDA on the basis of testimony
presented in public hearings. Present law requires the petitioner to
present FDA with experimental evidence on toxicity to establish
what tolerances, if any, will be safe, to show that the tolerances
can be met under the practical conditions of the pesticide use and
to provide practical methods of analysis for enforcement of the
tolerances.
The concept of "zero tolerance" should be distinguished from
that of "no residue." "No residue" is a determination by USDA,
based on experimental data, that none will remain from a par-
ticular pesticide use, irrespective of toxicity. "Zero tolerance" is
an FDA prohibition of any residue on a crop because the compound
is too toxic to permit a residue. The concepts of "zero tolerance"
and the "no residue" registration have been modified as more sensi-
tive detection methods become available. In practice r 1 .,
"zero tolerance" is interpreted by FDA in some cases to include a
detectable level of residue, lower than that believed to be pharma-
cologically significant.
In addition to toxicity data, the petitioner must also submit
information on the chemistry of the compound, reference to related
uses and residue measurements on the crop involved. If the raw
agricultural product is to be used for animal feed, data must be
submitted on residues in meat and milk. A method of analysis
suitable for enforcement purposes also must be submitted.
When a tolerance has been set by FDA, USDA registers the
pesticide which can then be marketed with approved labeling. No
pesticide can be shipped in interstate and foreign commerce with-
out USDA registration; however, by law USDA must grant regis-
tration "under protest" upon written demand of a petitioner
subsequent to registration refusal by USDA. At present, the pur-
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GUIDELINES AND REPORTS 1393
chaser cannot distinguish such a product from one which has been
accepted for registration because the label does not carry any
indication of its unsanctioned status.
A pesticide registration must be renewed every five years. Within
that interval petitioners may apply for increased tolerances or for
extension of existing tolerances to additional crops. Similarly, FDA
may alter residue tolerances if new information warrants. Lower
tolerances are not set unless the FDA believes it could prove in
court that the hazard is greater than formerly determined.
The Food and Drug Administration is responsible for establish-
ing safe tolerances of pesticide residues on food products and for
enforcing such tolerances by preventing illegal residues on inter-
state and foreign food shipments. The Department of Agriculture
has sole responsibility for approving registration for pesticide use
on any agricultural product other than food crops, on food crops
where no residue results, and for all nonagricultural uses.
Both USDA and FDA have enforcement programs. The USDA
is responsible for insuring that the marketed pesticides are prop-
erly labeled. The FDA is responsible for insuring that tolerances
are not exceeded. In addition, individual states may directly
control pesticides uses, and enforce their own tolerances for
produce sold within the state.
B. ADEQUACY OF PESTICIDE CONTROL
Federal laws and administrative practices relating to pesticides
are intended to assure both efficacy of the product and safety to the
purchaser, user, and the public. Decisions on efficacy appear to be
based on reliable evidence. Experiments are well designed, mean-
ingful controls are used, sample sizes are adequate, and conclusions
reached are supported by
[p. 15]
the data obtained. However, efficacy alone is not an adequate
criterion for judgment. Unless a pesticide proposed for registration
is equally effective in a less hazardous way than methods already
available, the Panel believes registration should be considered con-
servatively. As a corollary to cautious registration of new pesti-
cides, more hazardous compounds might well be removed from the
market when equally effective and less hazardous substitutes are
found. The Panel believes that it is necessary to modify the use of
some especially hazardous and persistent materials now registered.
The Panel has found that decisions on safety are not as well
based as those on efficacy despite recent improvements in the
procedures required by the Federal Food, Drug and Cosmetic Act
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1394 LEGAL COMPILATION—PESTICIDES
for the establishment of safe tolerances for pesticide residues on
food. Until 1954, the evidence of safety was submitted in the form
of testimony at public hearings, and tolerances were established
when the evidence appeared to support the application. At that
time, the manufacturer was not required to provide an analytical
method for the practical enforcement of the tolerance. Moreover,
FDA has no subpoena power to require testimony not voluntarily
offered. Amendments of the Act in 1954 materially improved these
procedures. In addition to requiring the submission of data on
chemistry, toxicology, and residues, it also required the petitioner
to provide a practical analytical method for use in enforcement.
The result was the provision of more data from animal experi-
ments and, in some cases, information on human pharmacology.
As an administrative principle, tolerances are set by FDA at
1/100 of the lowest level which causes effects in the most sensitive
test animals whenever data on human toxicity are not available.
However, tolerances have been set for some compounds such as
dieldrin, aldrin, heptachlor (epoxide) and chlordane, although a
"no effect" level in animals has never been determined. After re-
viewing the data on which tolerances are based, the Panel concludes
that, in certain instances, the experimental evidence is inadequate.
Recent review by FDA has also demonstrated several such ex-
amples and the tolerances are being reassessed.
The Panel believes that all data used as a basis for granting
registration and establishing tolerances should be published, thus
allowing the hypotheses and the validity and reliability of the data
to be subjected to c*"*'L'~al review by the public and the scientific
community.
The FDA has responsibility only for setting tolerances for pesti-
cides which remain on foods. Decisions on all the other uses
of these compounds and registration for all other compounds are
the responsibility of USDA. Thus the Department of Agriculture
regulatory staff evaluates and approves uses that bring pesticides
into intimate contact with people, such as mothproofing of clothes
and blankets, and applications to households, lawns, and gardens.
The Panel .believes that decisions on registrations, clearly related
to health, should be the responsibility of the Department of Health,
Education and Welfare. r , „-,
[p. 16]
Current registration procedures are primarily intended to pro-
tect people and domestic animals from damage by pesticides. The
protection of fish and wildlife resources will require affirmation
of this intent by Congress. Following such action by the Congress,
the Panel believes the Secretary of the Interior should actively
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GUIDELINES AND REPORTS 1395
participate in review of all registrations that may affect fish and
wildlife.
Federally operated or supported programs are subject to review
by the Federal Pest Control Review Board. In addition, an Interde-
partmental Committee on Pest Control exchanges information re-
garding control programs. An Armed Forces Pest Control Board
provides liaison and coordination within the Department of De-
fense and regulates sales of pesticides in military stores. There are
no provisions for federal control of use after sale except in federal
programs and by indirect means such as enforcement of residue
tolerances.
The Federal Pest Control Review Board was established in 1961
through joint actions of the Secretaries of Agriculture, Interior,
Defense, and Health, Education and Welfare, and is composed of
representatives from each of these Departments. Technical matters
are referred to staffs within the agencies for consideration and
advice, and occasionally to the Interdepartmental Committee on
Pest Control. The Board has not used consultants from outside the
Government. The basic responsibility for Federal pest control
operations is placed by statute in various departments and agen-
cies. The fact that these same agencies constitute the Federal Pest
Control Review Board restricts the Board's effectiveness in review-
ing the programs of member agencies. The Board carefully con-
siders programs before giving clearance and, when appropriate,
offers recommendations for altering proposed procedures. Although
many programs have been modified as a result of such reviews,
particularly by the incorporation of additional safeguards, the
discontinuation of a program has not been recommended.
More than half of the insecticides used in Federal programs are
applied for the control of pests introduced from foreign areas.
Quarantine is a first defense, but there are opportunities for pests
to spread. Through prompt action, the Mediterranean Fruit Fly
has been eradicated on three occasions during the last 33 years,
following introduction into Florida. In these cases, prompt eradica-
tion of the fly prevented its spread and the need for more extensive
use of chemicals.
Although eradication of a pest population is a laudable goal, it
is seldom realistic. Control programs by contrast, apply pesticides
in less volume, to a smaller land area, with fewer undesirable side
effects at any one time, yet produce the same economic results. The
gypsy moth, fire ant, Japanese Beetle, and white-fringed beetle
programs, which have been continued for years, are examples of
failures of the "eradication" approach. The acceptance of a phi-
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1396 LEGAL COMPILATION—PESTICIDES
losophy of control rather than eradication does not minimize the
technical or economic importance of a program, but acknowledges
the realities of biology. As new control techniques such as male
sterilization or highly specific attractants are developed for practi-
cal use, the elimination of some of our alien pests may become
technically and economically feasible. r ^ „-,
In 1962, the Federal Government supported control programs
involving the application of pesticides to more than 4 million acres,
at a cost of about 20 million dollars. Although the Federally sup-
ported programs represent only a small part of the total national
use of pesticides, individual programs may involve thousands of
acres of populated urban areas.
The Panel feels that Federal programs should be models of
correct practice for use in the guidance of states, localities and
private users. They should, therefore, be conducted not only with
attention to maximum effect on the target organisms, but with
further evaluation of the associated hazards. It would, in these
terms, be reasonable to expect that every large-scale operation be
followed by a complete report which would appear in the public
literature. , 1Q-.
[p. 18]
VI. RECOMMENDATIONS
The Panel's recommendations are directed to: an assessment of
the levels of pesticides in man and his environment; to measures
which will augment the safety of present practices; to needed
research and the development of safer and more specific methods
of pest control; to suggested amendments or public laws governing
the use of pesticides; and to public education.
A. IN ORDER TO DETERMINE CURRENT PESTICIDE LEVELS AND THEIK
TRENDS IN MAN AND HIS ENVIRONMENT, IT IS RECOMMENDED THAT
THE DEPARTMENT OP HEALTH, EDUCATION AND WELFARE
1. Develop a comprehensive data gathering program so that the
levels of pesticides can be determined in occupational workers, in
individuals known to have been repeatedly exposed, and in a sample
of the general population. As a minimum, the survey should include
determinations on fat, brain, liver and reproductive organs in adults
and infants; examinations to determine if placental transmission
occurs; and determination of levels which may be excreted in human
milk. These studies should use samples sufficiently large and prop-
erly drawn to obtain a clear understanding of the manner in which
these chemicals are absorbed and distributed in the human body.
2. Cooperate with other departments to develop a continuing
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GUIDELINES AND REPORTS 1397
network to monitor residue levels in air, water, soil, man, wildlife,
and fish. The total diet studies on chlorinated hydrocarbons initiated
by the Food and Drug Administration should be expanded. These
should, for example, include data on organophosphates, herbicides
and the carbamates in populated areas where they are widely used.
3. Provide Federal funds to assist individual states to improve
their capabilities for monitoring pesticide levels in foods which are
produced and consumed within the state.
B. IN ORDER TO AUGMENT THE SAFETY OF PRESENT PRACTICES, IT IS
RECOMMENDED THAT
1. The Food and Drug Administration proceed as rapidly as
possible with its current review of residue tolerances, and the
experimental studies on which they are based. When this review
is completed, it is recommended that the Secretary of Health, Edu-
cation and Welfare select a panel from nominations by the Na-
tional Academy of Sciences to revaluate toxicological data on pres-
ently used pesticides to determine which, if any, current residue
tolerances should be altered. Of the commonly used chemicals at-
tention should be directed first to heptachlor, methoxychlor, diel-
drin, aldrin, chlordane, lindane, and parathion because their
tolerances were originally based upon data which are in particular
need of review. Upholding the same standards, the Secretary
should ensure that new compounds proposed for registration be
rigorously evaluated.
[p. 19]
2. The existing Federal advisory and coordinating mechanisms
be critically assessed and revised as necessary to provide clear
assignments of responsibility for control of pesticide use. The
Panel feels that the present mechanisms are inadequate and that
it is necessary to provide on a continuing basis for:
(a) Review of present and proposed Federal control and
eradication programs to determine if, after consideration
of benefits and risks, some programs should be modified
or terminated.
(b) Development and coordination of a monitoring program
conducted by Federal agencies to obtain timely, system-
atic data on pesticide residues in the environment.
(c) Coordination of the research programs of those Federal
agencies concerned with pesticides.
(d) Initiation of a broad educational program delineating the
hazards of both recommended use and of the misuse of
pesticides.
-------
1398 LEGAL COMPILATION—PESTICIDES
(e) Review of pesticide uses and, after hazard evaluation,
restriction or disapproval for use on a basis of "reason-
able doubt" of safety.
(f) A forum for appeal by interested parties.
3. The National Academy of Sciences-National Research Council
be requested to study the technical issues involved in the concepts
of "zero tolerance" and "no residue" with the purpose of suggesting
legislative changes.
4. The Secretaries of Agriculture, Interior, and Health, Educa-
tion and Welfare review and define their roles in the registration
of pesticides that are not present on food, but that may impinge on
fish and wildlife or come into intimate contact with the public.
5. The accretion of residues in the environment be controlled by
orderly reduction in the use of persistent pesticides.
As a first step, the various agencies of the Federal Government
might restrict wide scale use of persistent insecticides except for
necessary control of disease vectors. The Federal agencies should
exert their leadership to induce the states to take similar actions.
Elimination of the use of persistent toxic pesticides should be
the goal.
C. RESEARCH NEEDS
1. In order to develop safer, more specific controls of pests, it
is recommended that government sponsored programs continue to
shift their emphasis from research on broad spectrum chemicals to
provide more support for research on: p _»-,
a. Selectively toxic chemicals
b. Non-persistent chemicals
c. Selective methods of application
d. Non-chemical control methods such as the use of attractants
and the prevention of reproduction.
In the past few years, the Department of Agriculture has shifted
its programs toward these specific controls. The Panel believes this
trend should be continued and strengthened. Production of safer,
more specific and less persistent pesticide chemicals is not an
unreasonable goal; but its attainment will require extending re-
search efforts beyond empirical approaches to more fundamental
..studies of subjects such as: The mode of action of pesticides;
comparative toxicology; the metabolism of compounds in insects,
plants, and higher animals; and the processes of chemical degrada-
tion and inactivation in nature. Such studies will also provide the
information necessary to control those pests which are rapidly
becoming resistant to currently available chemicals. Intensified
effort is needed in the search for selective methods of pesticide
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GUIDELINES AND REPORTS 1399
application. Compounds are often applied in excessive quantity or
frequency because of such inefficiencies as drift, uneven coverage,
or distribution methods insufficiently specific to reach the target
pest.
2. Toxicity Studies Related to Man. The toxicity data upon which
registrations and tolerances are based should be more complete
and of higher quality. Although data are available on acute toxic
effects in man, chronic effects are more readily demonstrated in
animals because their generation time is shorter, and thus the
natural history of pesticide effects is telescoped chronologically.
However, there will continue to be uncertainties in the extrapola-
tion from experimental animals to man, and in the prediction of
the nature and frequency of effects in humans on the basis of those
observed in other forms of life.
The Panel recommends that toxicity studies include determina-
tion of:
a. Effects on reproduction through at least two generations in
at least two species of warm-blooded animals. Observations
should include effects on fertility, size and weight of litter,
fetal mortality, teratogenicity, growth and development of
sucklings and weanings.
b. Chronic effects on organs of both immature and adult ani-
mals, with particular emphasis on tumorigenicity and other
effects common to the class of compounds of which the test
substance is a member.
c. Possible synergism and potentiation of effects of commonly
used pesticides with such commonly used drugs as sedatives,
tranquilizers, analgesics, antihypertensive agents and ste-
roid hormones, which are administered over prolonged
periods. [p 21]
3. Toxicity Studies Related to Wildlife. The Panel recommends
expanded research and evaluation by the Department of the Inte-
rior of the toxic effects of pesticides on wild vertebrates and inver-
tebrates.
The study of wildlife presents a unique opportunity to discover
the effects on the food chain of which each animal is a part, and to
determine possible pathways through which accumulated and, in
some cases, magnified pesticide residues can find their way directly
or indirectly to wildlife and to man.
4. Amplification of Research Resources. Only by stimulating
training and basic investigation in the fields of toxicology and
ecology are research needs likely to be met. An increased output of
basic research data and a continuing supply of capable research
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1400 LEGAL COMPILATION—PESTICIDES
personnel could be ensured by a system of grants and contracts.
Training grants, basic research grants, and contracts to univer-
sities and other nongovernmental research agencies funded by the
Departments of Agriculture, Interior, and Health, Education and
Welfare would stimulate this research. In order to accelerate im-
mediate progress, it might prove useful to explore the contributions
which can be made by competent research people and their facilities
in other countries.
D. IN ORDER TO STRENGTHEN PUBLIC LAWS ON PESTICIDES, IT IS
RECOMMENDED THAT AMENDMENTS TO PUBLIC LAWS BE REQUESTED.
THESE SHOULD
1. Eliminate "Protest" registrations. The Panel concurs with the
Department of Agriculture that these technically evade the intent
of the public laws. Industry needs an appeal mechanism, however,
to protect it from arbitrary decisions. Public hearings could be
held on such appeals.
2. Require that every pesticide formulation carry its official reg-
istration number on the label. The Department of Agriculture has
recommended such an amendment as a means of increasing the
protection of the consumer.
3. Clarify the intent of the Federal Insecticide, Fungicide, and
Rodenticide Act to protect fish and wildlife by including them as
useful vertebrates and invertebrates.
4. Provide, as a part of the operating budgets of Federal control
and eradication programs, funds to evaluate the efficiency of the
programs and their effects on nontarget organisms in the environ-
ment. Results of these studies should be published promptly.
Approximately 20 million dollars were allocated to pest control
programs in 1962, but no funds were provided for concurrent field
studies of effects on the environment. The Department of Agricul-
ture has repeatedly suggested that other interested agencies partici-
pate in the general programs, but funds have not been available
except by diversion from other essential agency functions.
[P. 22]
E. TO ENHANCE PUBLIC AWARENESS OF PESTICIDE BENEFITS AND
HAZARDS, IT IS RECOMMENDED THAT
The appropriate Federal departments and agencies initiate pro-
grams of public education describing the use and the toxic nature
of pesticides. Public literature and the experiences of panel mem-
bers indicate that, until the publication of "Silent Spring" by
Rachel Carson, people were generally unaware of the toxicity of
pesticides. The government should present this information to the
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GUIDELINES AND REPORTS 1401
public in a way that will make it aware of the dangers while
recognizing the value of pesticides.
[p. 23]
PRESIDENT'S SCIENCE ADVISORY COMMITTEE
PANEL ON THE USE OF PESTICIDES
H. Stanley Bennett, Dean, Division of Biological Sciences, University of
Chicago.
Kenneth Clark, Dean, College of Arts and Sciences, University of Colorado.
Paul M. Doty, Professor of Chemistry, Harvard University.
William H. Drury, Jr., Director, Hatheway School of Conservation Education,
Massachusetts Audubon Society.
David R. Goddard, Provost, University of Pennsylvania.
James G. Horsfall, Director, Connecticut Agricultural Experiment Station.
William D. McElroy, Chairman, Department of Biology, The Johns Hopkins
University.
James D. Watson, Professor of Biology, Harvard University.
Colin M. MacLeod, Chairman, Professor of Medicine, School of Medicine,
New York University.
TECHNICAL ASSISTANTS, OFFICE OF SCIENCE AND TECHNOLOGY
Peter S. Bing, John L. Buckley, James B. Hartgering, Gay E. G. Luce.
[p. 24]
Harvey Brooks, Dean, Division of Engineering and Applied Physics, Har-
vard University.
Paul M. Doty, Professor of Chemistry, Harvard University.
Richard L. Garwin, Watson Research Laboratory, Columbia University—
International Business Machines Corp.
Edwin R. Gilliland, Professor of Chemical Engineering, Massachusetts
Institute of Technology.
Donald F. Hornig, Professor of Chemistry, Princeton University.
George B. Kistiakowsky, Professor of Chemistry, Harvard University.
Colin M. MacLeod, Professor of Medicine, School of Medicine, New York
University.
William D. McElroy, Chairman, Department of Biology, The Johns Hopkins
University.
Wolfgang K. H. Panofsky, Director, Stanford Linear Accelerator Center,
Stanford University.
[p. 25]
John R. Pierce, Executive Director, Research, Communications Principles
Division, Bell Telephone Laboratories.
Frank Press, Director, Seismological Laboratory, California Institute of
Technology.
Edward M. Purcell, Professor of Physics, Harvard University.
Frederick Seitz, President, National Academy of Sciences.
John W. Tukey, Professor of Mathematics, Princeton University.
Jerrold R. Zacharias, Professor Physics, Massachusetts Institute of Tech-
nology.
Jerome B. Wiesner, Chairman, Special Assistant to the President for Science
and Technology, The White House.
[p. 26]
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1402 LEGAL COMPILATION—PESTICIDES
4.2b DEFICIENCIES IN ADMINISTRATION OF FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT, HOUSE
COMMITTEE ON GOVERNMENT OPERATIONS
H.R. REP. No. 91-637, 91st Cong., 1st Sess. (1969)
DEFICIENCIES IN ADMINISTRATION OF FEDERAL INSEC-
TICIDE, FUNGICIDE, AND RODENTICIDE ACT
NOVEMBER 13,1969.—Committed to the Committee of the Whole House on the
State of the Union, and ordered to be printed
Mr. DAWSON, from the Committee on Government Operations,
submitted the following'
ELEVENTH REPORT
[To accompany llth report on deficiencies in administration of Federal Insec-
ticide, Fungicide, and Rodenticide Act]
BASED ON A STUDY BY THE INTERGOVERNMENTAL RELATIONS
SUBCOMMITTEE
On November 12, 1969, the Committee on Government Opera-
tions approved and adopted a report entitled "Deficiencies in Ad-
ministration of Federal Insecticide, Fungicide, and Rodenticide
Act." The chairman was directed to transmit a copy to the Speaker
of the House.
INTRODUCTION
Under the rules of the House of Representatives, the Committee
on Government Operations has responsibility for studying the oper-
ation of Government activities at all levels from the standpoint of
economy and efficiency. The committee also has responsibility for
receiving and examining reports of the Comptroller General of the
United States. These responsibilities, insofar as they relate to the
Department of Agriculture, the Department of Health, Education
and Welfare, and a number of other agencies, have been assigned
by the committee to the Intergovernmental Relations Subcom-
mittee. In accordance with this assignment, the subcommittee has
ben examining the administration of the Federal Insecticide, Fun-
gicide, and Rodenticide Act.
The subcommittee began its investigation of this subject area
late in 1968, after receiving a report from the Comptroller Gen-
eral concerning "Need to Improve Regulatory Enforcement Pro-
cedures Involving Pesticides" which disclosed the existence of
serious deficiencies in the operations of the Pesticides Regulation
Division of the Depart- [p. 1]
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GUIDELINES AND REPORTS 1403
ment of Agriculture's Agricultural Research Service. The sub-
committee's investigation and a second report by the Comptroller
General revealed further serious deficiencies and led to preparation
of this report.
The subcommittee held public hearings on May 7 and June 24,
1969, with testimony from the following officials of the Depart-
ment of Agriculture and the Department of Health, Education,
and Welfare:
DEPARTMENT OF AGRICULTURE
Office of the Secretary
Dr. Ned D. Bayley, Director, Science and Education.
Agricultural Research Service
Dr. George W. Irving, Jr., Administrator.
Dr. Robert J. Anderson, Associate Administrator.
Dr. Harry W. Hays, Director, Pesticides Regulation Division.
Lowell E. Miller, Assistant Director for Enforcement, Pesti-
cides Regulation Division.
Harold G. Alford, Assistant Director for Registration, Pesti-
cides Regulation Division.
Anthony J. Dellavecchia, Head, Inspection Services and Acci-
dent Investigation, Pesticides Regulation Division.
Office of the General Counsel
Charles W. Bucy, Assistant General Counsel for Marketing,
Regulatory Laws, Research and Operations.
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
Food and Drug Administration
R. E. Duggan, Deputy Associate Commissioner for Compliance.
Dr. T. H. Harris, Chief, Division of Pesticide Registration,
Office of Product Safety.
Lessel L. Ramsey, Assistant Director for Regulatory Programs,
Bureau of Science.
Office of the General Counsel
William W. Goodrich, Assistant General Counsel, Food, Drug,
and Environmental Health Division.
Testimony at the hearings was supplemented by data furnished
for the record. Additional information was obtained by the sub-
committee staff through interviews with personnel of the agen-
cies concerned and through examination of material in their files.
The subcommittee investigation was concentrated on adminis-
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1404 LEGAL COMPILATION—PESTICIDES
tration of the Federal Insecticide, Fungicide, and Rodenticide
Act and related statutes; it did not extend to questions such as
the long-range effect of persistent pesticides on the environment.
ACKNOWLEDGMENT
The subcommittee wishes to express its appreciation for the
assistance provided by the General Accounting Office in connec-
tion with its investigation. The subcommittee particularly appre-
ciates the contribution made by Mr. Morton A. Myers and Mr.
Richard E. Chervenak of the GAO staff.
[p. 2]
SUMMARY
Federal regulation of pesticides
Since 1947, the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) has required that all pesticides shipped in inter-
state commerce be registered with the U.S. Department of
Agriculture (USDA). To qualify for registration, a pesticide
must be both safe and effective when used as directed. The act
provides criminal penalties for the interstate shipment of pesti-
cide products which are unregistered, adulterated or misbranded.
Under the act, a pesticide is "misbranded" if its labeling contains
false or misleading statements or if it does not bear clearly under-
standable warning statements adequate if complied with to pre-
vent injury and protect the public. USDA is authorized by the
act to initiate court proceedings for seizure of pesticides which
violate the act.
A pesticide registration may be canceled at any time, in accord-
ance with procedures specified in the act, if it does not appear
that the product or its labeling comply with provisions of the act.
A registration may also be canceled if it is not renewed every 5
years. A registration may be suspended immediately if the Secre-
tary of Agriculture determines such action is necessary to prevent
an imminent hazard to the public.
The Federal Food, Drug, and Cosmetic Act requires establish-
ment of a tolerance by the Food and Drug Administration (FDA)
in the event a registered use of a pesticide will leave a residue on
food; in the absence of a tolerance (or an exemption from the tol-
erance requirement) food containing a pesticide residue is con-
sidered adulterated.
Primary responsibility for carrying out provisions of FIFRA is
assigned to the Pesticides Regulation Division (PRD), a unit of
USDA's Agricultural Research Service (ARS). Within PRD, ad-
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GUIDELINES AND REPORTS 1405
ministrative details and records relating to registration applica-
tions and cancellation proceedings are handled by the Registration
Branch, although product evaluation staffs are responsible for
making final decisions concerning approval of applications or can-
cellation of registrations. The Enforcement Branch is responsible
for conducting activities necessary to effectively regulate market-
ing of pesticides, including inspection, sampling and laboratory
analysis of products in marketing channels, seizure and recall
actions, and preparing cases for criminal prosecution.
PRD specialists review data submitted by manufacturers or
formulators of products proposed for registration in order to
determine the safety and effectiveness of such products, and the
adequacy of proposed label warnings and directions. If the data
submitted is not considered sufficient, more information is request-
ed. Under a 1964 interdepartmental agreement, pesticide labels
submitted for registration are reviewed by the Department of
Health, Education, and Welfare (HEW) from the standpoint of
possible effects of the pesticide on human health and the Depart-
ment of Interior in terms of the effect on fish and wildlife.
More than 45,000 products involving some 900 different chemi-
cal compounds are currently registered. r „,
Lp. oj
GAO criticism of enforcement procedures
In September 1968, the General Accounting Office (GAO) issued
a highly critical report concerning enforcement procedures fol-
lowed by PRD through mid-1967. The report included the follow-
ing disclosures:
(1) When its inspectors found a potentially hazardous or inef-
fective product, it was PRD practice to take seizure action against
only the quantity of pesticide at the location where the sample
was obtained. No action was taken to locate and remove from the
market additional quantities of the same product being held for
sale at other locations, although FIFRA authorizes access to ship-
ping records for this purpose.
(2) Despite evidence of repeated violations by some shippers,
PRD had not initiated a single criminal prosecution, for 13 years.
Moreover, it had no procedures for determining under what cir-
cumstances such action would be taketi.
(3) Notices of judgments obtained in actions (primarily sei-
zures) instituted under FIFRA had not been published as required
by the act.
Subcommittee investigation
The subcommittee began its investigation shortly after receiv-
-------
1406 LEGAL COMPILATION—PESTICIDES
ing the GAO report. At the same time, the GAO continued work
on a second report dealing- with PRD's registration of certain
products containing lindane. In the second report, issued in Feb-
ruary 1969, the GAO found that PRD had continued to register
lindane products for use in continuous vaporizers in restaurants
and other commercial and industrial establishments for many
years, despite repeated objections by the Public Health Service
(PHS) and other public and private organizations, without resolv-
ing the safety questions involved.
Subcommittee hearings were held on May 7 and June 24, 1969.
At the hearings, USDA officials acknowledged the accuracy of the
GAO reports and stated that the reports had been helpful.
Changes in enforcement procedures
Testimony at subcommittee hearings established that significant
changes in PRD enforcement procedures and operations were made
after the mid-1967 appointment of Lowell E. Miller as assistant
director for enforcement. In September 1967, PRD began request-
ing manufacturers to voluntarily recall violative products from
the market. Formal procedures for requesting voluntary recall
action, to be followed by examination of shipping records and mul-
tiple seizure actions in instances where shippers refused to take
voluntary action, were approved May 5, 1969. Operating guide-
lines for referring cases to the Department of Justice were estab-
lished, and a criminal indictment was returned by a Chicago grand
jury in March 1969. Steps were taken to resume publication of
notices of judgment.
Other testimony disclosed that a newly formed prosecutions and
import section was staffed by only one man at the professional
level, who was responsible for supervising all imports of pesticides
in addition to preparing cases for prosecution. PRD witnesses
admitted it was unlikely that one man working part time would be
able to reduce or even keep up with the backlog of cases being
reviewed for prosecution.
[p. 4]
Claimed improvements in registration procedures
USDA witnesses acknowledged the existence of past deficiencies
in registration procedures, but contended that significant improve-
ment had been made. They attributed much of the progress claimed
to the work of a 1965 task force which studied PRD and to the
appointment in mid-1966 of its chairman, Dr. Harry W. Hays, as
director of the Pesticides Regulation Division.
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GUIDELINES AND REPORTS 1407
Lack of interagency cooperation
The 1964 interdepartmental agreement provides for depart-
mental representatives to try to resolve differences, if one agency
believes a registration proposal should be rejected. If agreement
cannot be reached within two weeks of the initial objection, the
agreement provides for the matter to be referred directly to the
Secretary of the Department responsible for final action. The
agreement further provides for a general conference of depart-
mental representatives at least once each year.
Dr. Harry Hays estimated at the May 7 hearing that only about
half a dozen of some 45,000 registered products had been approved
by USDA over HEW objections. Further inquiry by the subcom-
mittee disclosed that, according to USDA figures, HEW had
objected to a total of 1,663 proposed registrations or reregistra-
tions during a 5-year period from July 1, 1964, through June 30,
1969. Neither HEW nor USDA could tell the subcommittee how
many of the 1,633 products objected to were actually registered,
since USDA did not keep records of products registered over objec-
tions and did not inform HEW as to the action taken. However,
USDA advised the subcommittee that during fiscal year 1969 alone
there apparently were 185 registrations over HEW objections.
USDA witnesses admitted that not one of the 1633 HEW objec-
tions was referred to the Secretary of Agriculture in accordance
with provisions of the Interdepartmental Agreement, even though
the 1965 task force—headed by Dr. Hays—had called attention to
the lack of compliance with this requirement. Dr. George W.
Irving, ARS Administrator, took the position that ARS had "re-
solved" the issues involved in the objections by placing the prod-
ucts on the market and there consequently was no need to refer
the matters to the Secretary. USDA witnesses also testified that
the annual meetings required by the agreement had not been held.
Memoranda in HEW files indicate that some HEW officials con-
cluded before the end of 1964 that PRD had no intention of com-
plying with the terms of the Interdepartmental Agreement, and
that this belief continued more or less unchanged for several years
thereafter. On May 7, 1969, USDA witnesses told the subcommit-
tee that a meeting of USDA, HEW and Interior Department repre-
sentatives had been held on March 19,1969, to try to improve inter-
departmental cooperation in connection with the agreement. The
meeting apparently was not completely successful, since the sub-
committee subsequently located a memorandum indicating that an
HEW request for information on products registered over objec-
tions had been turned down in April 1969 by Dr. Hays on the
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1408 LEGAL COMPILATION—PESTICIDES
ground that the information, if provided, might be used against
him.
Misconception of burden of proof
Until early 1964, the Federal Insecticide, Fungicide, and Roden-
ticide Act authorized "protest registration." Under the law, PRD
was required to register a product, if the applicant insisted, even
though PRD did not believe it had been shown to be safe; the prod-
uct could then be removed from the market only on the basis of
evidence sufficient to justify a court decision. FIFRA was amend-
ed in May 1964 to eliminate protest registration and make it clear
that the burden of establishing the safety of a pesticide product
must be met by the applicant before it could be registered. Al-
though some USDA statements acknowledged that the burden of
proof of safety was on the applicant, other testimony indicated
that PRD had, in effect, shifted this burden by registering pesti-
cides over objections unless the objectors could produce satisfac-
tory evidence of hazard.
Food adulteration
Under the Federal Food, Drug, and Cosmetic Act, any food in
interstate commerce which bears or contains any added poisonous
or deleterious substance is considered adulterated unless a toler-
ance (or an exemption from the tolerance requirement) for such
substance has been granted by FDA and the amount of the sub-
stance does not exceed the tolerance.
FIFRA contains no specific provision relating to contamination
of food. However, the position of USDA, as reported in a 1965
study made by the National Academy of Sciences under a joint
USDA-HEW contract, is that directions for use of a pesticide are
not adequate to protect the public if it might leave a residue on
food which would be subject to FDA action.
The subcommittee investigation disclosed that USDA had re-
ceived an FDA study in 1953 which concluded that the use of
lindane vaporizers in restaurants would leave residues on food. It
further disclosed that USDA continued to register and reregister
lindane for use in continuous vaporizers in restaurants for more
than 15 years thereafter, even though no tolerance had been grant-
ed or even requested for such residues. PRD registration files for a
DDVP resin strip distributed by the Shell Chemical Co. contain
documents establishing that a similar situation occurred in con-
nection with that product over a period of several years.
USDA witnesses admitted that other units of the Department of
Agriculture prohibited use of lindane vaporizers and DDVP strips
-------
GUIDELINES AND REPORTS 1409
in food processing establishments under their jurisdiction at the
same time PRD was approving registration of such products for
use around food. The subcommittee investigation also disclosed
that FDA had refused to approve a 1963 application for a toler-
ance for residues of pyrethrins and piperonyl butoxide resulting
from use of a vaporizing device in food processing areas.
Basis for lindane cancellation action
USDA finally announced that it was taking action to cancel
registrations of lindane products for use in continuous vaporizers
on April 29, 1969, some 2 months after release of the GAO report
on this subject and a few days before the subcommittee's first
hearing. USDA witnesses contended that the agency's failure to
act for some 16 years r „,
Lp. bj
after it became aware of safety questions concerning lindane
products was necessitated by a lack of scientific data establishing
that the use of such products was hazardous. They claimed, more-
over, that such data had not become available until very recently,
despite vigorous and long-continued efforts on their part to obtain
it previously. However, further inquiry by the subcommittee indi-
cated that the data cited by PRD's medical advisors in recom-
mending cancellation had been in PRD's hands or readily available
to it for more than 2 years.
The subcommittee investigation also disclosed that when PRD
finally decided to conduct its own tests after nearly 16 years, it
took only 5 days to establish that use of lindane vaporizers would
result in illegal residues on food. Action to require label warnings
against use of DDVP strips in areas where food is prepared or
served was not initiated until September 1969.
Confusing and contradictory pesticide labeling
Early stages of the subcommittee's investigation raised questions
concerning the adequacy of labeling approved by PRD for a num-
ber of pesticide products. In some instances, safety warnings and
directions for use appeared to be contradictory. For example, prod-
ucts containing thallium sulfate—a highly toxic ant and rat poi-
son—bore warnings that the poison should be kept away from
children; however, the directions for use called for the product to
be placed on floors and in other places accessible to ants and rats
—and obviously accessible to children. Products containing lin-
dane and DDVP bore warnings against contamination of food,
but their labels indicated they were approved for use in restau-
rants under conditions practically certain to result in contamina-
tion of any exposed food.
-------
1410 LEGAL COMPILATION—PESTICIDES
When questioned about this, Dr. Hays assured the subcommittee
that products presently being approved for use were being care-
fully screened so that obviously contradictory labeling could no
longer get by. However, the subcommittee investigation disclosed
that a concentrated fly and roach spray product bearing such label-
ing had been approved in May 1969, a few days after the sub-
committee's first hearing. In this instance, the warning notice
cautioned the user to "Use in well ventilated rooms or areas only"
while the directions for use began by instructing him to "Close all
doors, windows and transoms."
The subcommittee investigation also disclosed that PRD had
approved a label claiming that a widely advertised detergent
"germproofs" in cold water, although Dr. Hays acknowledged
under questioning that the product would not kill germs.
PRD advised the subcommittee that it had entered into a con-
tract with the University of Illinois in June 1968 for a study of
pesticide labeling. Preliminary reports indicate that the research-
ers conducting the study nave concluded that most pesticide users
do not read labels and that those who do find the labels difficult to
understand.
'Inadequate information on pesticide poisonings
Dr. Hays told the subcommittee that PRD places considerable
reliance on accident reports as a means of detecting dangerous
pesticides whose potential hazards might not have been fully
apparent when they were registered. The subcommittee was also
informed that USDA's accident reporting system appeared to be
working very well. Further inquiry disclosed that USDA received
reports of 150 to 175 pesticide r _,
poisoning incidents during 1968. Most of these did not involve
humans; the 52 that did involved a total of 163 persons.
Dr. Hays indicated it was his opinion that the reports received
by USDA represented a "fair share" of the total number of pesti-
cide poisonings occurring each year. He subsequently stated that
he was unaware that the HEW National Clearinghouse of Poison
Control Centers receives approximately 5,000 reports of pesticide
poisonings annually and that officials of that unit believe the total
number of such poisonings is 8 to 10 times the number reported to
the poison control centers.
Failure to initiate cancellation actions
Since 1964, USDA has had specific authority to cancel registra-
tions of pesticides which do not appear to comply with the provi-
sions of FIFRA. Under the law, cancellation action must be initi-
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GUIDELINES AND REPORTS 1411
ated by giving notice to the registrant. Thirty days after such
notice, the registration is automatically cancelled unless the regis-
trant takes corrective action (if corrective action is possible),
requests referral of the matter to an advisory committee selected
by the National Academy of Sciences or asks for a public hearing.
After reviewing the report of an advisory committee or the record
of a public hearing, the Secretary issues an order with respect to
cancellation or modification of the registration. If the registrant
is dissatisfied with an order issued after an advisory committee
study, he may still request a public hearing.
Although the 1964 amendments to FIFRA provided basic legal
authority for cancellation proceedings, the authority could not be
utilized in contested cases without rules of practice for hearings
and procedures for referral of matters to advisory committees.
The subcommittee investigation disclosed that such rules and pro-
cedures were not adopted until August 29, 1969. A number of re-
quests for referrals to advisory committees or public hearings were
received prior to 1969; documents in PRD files indicate that when
such requests were received, efforts to pursue the cancellation
action were abandoned and the product involved was simply left
on the market. Insofar as the subcommittee is aware, PRD has
never secured cancellation of a registration in a contested case.
The subcommittee investigation also disclosed that PRD had
failed to even send cancellation notices to distributors of certain
arsenic compounds, although it had decided nearly 2 years before
on the basis of "numerous accidents involving children and domes-
tic animals" that such products were too dangerous to be sold for
use in or around the home.
Suspension authority used only once
FIFRA authorizes suspension of pesticide registrations when
USDA finds such action is necessary to prevent an imminent haz-
ard to the public. However, testimony at subcommittee hearings
indicated that this has occurred in only one instance. PRD officials
testified that registration of a DDVP strip distributed by the Aero-
seal Co. had been suspended in March 1969 after representatives
of Shell Chemical Co. complained that the Aeroseal product was
not the same as the Shell DDVP strips even though it had been
registered on that basis. Although the Aeroseal product contained
the same amount of DDVP as the Shell resin strip, Dr. Hays testi-
fied that he was concerned that the r
blotter type material in which the DDVP was impregnated might
permit its release in concentrations "that could produce some very
-------
1412 LEGAL COMPILATION—PESTICIDES
serious effects." Despite his expressed concern about the Aeroseal
DDVP strip, however, Dr. Hays testified that he had taken no
action to require Shell to remove from the market or relabel DDVP
strips being sold without a required warning against use in nur-
series or rooms where infants, ill or aged persons were confined
nor did he see any particular need for such action.
Lack of action to protect 'public from hazardous products
Although the subcommittee investigation did not disclose any
instance (other than the Aeroseal matter) in which a registration
had been cancelled or suspended in a contested proceeding, there
were instances in which registrants more or less voluntarily agreed
to cancellation of registrations for products regarded as particu-
larly hazardous, such as those containing thallium sulfate. Testi-
mony at subcommittee hearings disclosed that PRD had no pro-
cedures to insure that its enforcement personnel were notified
when pesticide registrations were cancelled or amended for safety
reasons. Moreover, testimony by Dr. Hays disclosed that he had
deliberately left violative products on the market to be sold after
cancellation or amendment of registrations.
While obviously necessary to protect the public, removal of haz-
ardous pesticides from marketing channels does not prevent injury
to an unsuspecting buyer who already has the product in his home.
Although other units of the Agricultural Research Service appar-
ently take prompt action to warn against possible hazards to ani-
mals from regulated products, PRD witnesses testified that there
were no procedures for warning the public of specific hazards from
particular pesticide products.
Federal conflict-of-interest laws
Federal conflict of interest laws prohibit Government employees,
including consultants serving on an intermittent or temporary
basis, from participating personally and substantially in their
official capacity in matters in which they have a financial interest.
The prohibition also applies to matters in which, to the Govern-
ment employee's knowledge, a private organization which employs
him or with which he is negotiating or has an arrangement con-
cerning prospective employment has a financial interest. Former
Federal employees are prohibited from acting as agent or attorney
for anyone other than the United States in connection with matters
involving a particular party or parties in which the United States
is a party or has a direct and substantial interest if the former
employee participated personally and substantially in the matter
as a Government employee.
-------
GUIDELINES AND REPORTS 1413
Appointment of Shell official to registration task force
In July 1965, the Secretary of Agriculture announced appoint-
ment of a seven-member task force, headed by Dr. Harry Hays, to
study procedures used by PRD in determining the safety and
effectiveness of pesticides offered for Federal registration. Dr. T.
Roy Hansberry, an official of a Shell Chemical Co. research affiliate
at Modesto, Calif., was the only member of the task force employed
by private industry. Although Shell Chemical Co. is one of the
larger producers of pesticides
[p. 9]
and had registered more than 160 products before the end of 1965,
an as yet unidentified individual in the ARS Personnel Division
noted on Dr. Hansberry's personnel clearance form that ARS:
* * * does not have, or know of, any official business with
the persons, firms, or institutions with which Dr. Hansberry
has other financial interests * * * which might constitute a
conflict of interest.
Failure to keep minutes of meetings
Although the subcommittee was informed that the principal
reason for wanting Dr. Hansberry on the task force was so that he
could review procedures, facilities, and personnel at PRD labora-
tories, documents located by the subcommittee indicate that Dr.
Hansberry was assigned to a three-member subcommittee which
reviewed criteria used by PRD in determining whether registra-
tion applications should be approved. Minutes were kept for only
one meeting of the task force; they were kept by Harold Alford, a
PRD staff member who had been named Executive Secretary of
the task force. According to the minutes, Mr. Alford reminded
the group at the close of the first meeting that there were restric-
tions in the law with respect to disclosure of confidential informa-
tion and that this should be thoroughly understood since Dr. Hans-
berry was associated with private industry. At the beginning of
the next meeting, Mr. Alford testified, he was told by Dr. Hays
that his services would no longer be required; no minutes were
kept thereafter. Although Alford's appointment had been an-
nounced by the Secretary, the subcommittee investigation disclosed
no evidence that his dismissal had been approved by—or even
made known to—the Secretary.
Activities of John S. Leary, Jr., relating to Shell DDVP strip
registration
Documents in PRD files indicate that the initial registration of
Shell's DDVP strip was approved early in 1963 after John S.
-------
1414 LEGAL COMPILATION—PESTICIDES
Leary, Jr., then PRD's Chief Staff Officer for Pharmacology, over-
ruled an objection raised by one of his subordinates. PRD records
also indicate that Mr. Leary participated in meetings involving
the safety of DDVP strips with representatives of Shell and of
Government agencies in 1964 and 1965. During this period, ARS
and HEW records reflect consistent opposition by HEW personnel
to the continued registration of DDVP strips and lindane and py-
rethrum products for use in vaporizing devices. Late in 1965, after
ARS declined to participate in a joint study, an Ad Hoc Commit-
tee was appointed by the Public Health Service to study safety
questions relating to use of the above products. The Ad Hoc Com-
mittee met in Washington on November 19, 1965. All eight of its
members subsequently recommended against continued use of
lindane vaporizers; six of the eight also opposed DDVP strips and
pyrethrin vaporizers.
In September 1966, the report of the PHS Ad Hoc Committee
was sent by the Surgeon General to the Agricultural Research
Service. In October, Dr. Harry Hays called a meeting of three
PRD medical consultants to consider safety questions relating to
the same products covered by the PHS Ad Hoc Committee report.
The subcommittee investigation disclosed no evidence that the
medical consultants were
[p. 10]
given copies of the PHS report; they were, however, given copies
of a six-page memorandum on vaporized pesticides prepared for
Dr. Hays by Mr. Leary. By contrast with the PHS report, the
Leary memorandum did not oppose continued registration of
DDVP strips.
Leary action involving DDVP after accepting Shell position
USDA records indicate that on November 14, 1966, Mr. Leary
resigned, effective December 31, 1966, to accept a position with
Shell Chemical Co. PRD files contain a memorandum dated Decem-
ber 6,1966, from Mr. Leary to Dr. Hays reviewing the PHS report
on vaporized pesticides. The Leary memorandum stated that the
PHS report "serves no useful purpose" and did not justify any
change in the registration status of vaporized pesticides.
Leary meets with PRD officials on behalf of Shell
In 1967 and early 1968, PRD informed Shell Chemical Co. on
several occasions that a warning against use around infants, ill or
aged persons must appear on the label of its DDVP strip. On
July 15, 1968, representatives of Shell Chemical Co. met with
Dr. Hays and Mr. Alford of PRD to argue that the requested
-------
GUIDELINES AND REPORTS 1415
warning was not necessary. Correspondence and documents in
PRD files, as well as statements by Dr. Hays and Mr. Alford,
indicate that John S. Leary, Jr., was present and took an active
part. The subcommittee investigation also disclosed that Mr. Leary
visited the Atlanta offices of the PHS pesticides program to discuss
matters related to continued registration of Shell's DDVP strip.
Utilization of same medical consultant by PRD and Shell
The subcommittee investigation disclosed that Dr. Mitchell R.
Zavon was on the rolls as a consultant to the Pesticides Regulation
Division almost continuously from March 1963 until June 1969.
During this entire period, Dr. Zavon apparently was also serving
as a medical consultant to Shell Chemical Co.
In April 1964 and again in May 1965, when Dr. Zavon was
reappointed a PRD consultant for 1-year periods, the USDA
Office of General Counsel noted his connection with Shell Chemical
Co. The ARS Personnel Division was asked to especially call the
conflict-of-interest laws and regulations to Dr. Zavon's attention
in order that any possible conflict of interest between his PRD
duties and his position with Shell might be avoided.
Zavon scientific studies on DDVP
The subcommittee investigation disclosed that Dr. Zavon, indi-
vidually or with others, conducted a number of scientific studies
used by Shell to support its contention that DDVP was safe. A
1964 study in which food samples collected under Dr. Zavon's
direction were sent to Shell laboratories in Modesto, Calif., for
analysis resulted in a finding that use of DDVP strips in restau-
rants for 1-and 2-hour periods did not leave residues in exposed
food; by contrast, studies carried out by others found that use
of DDVP strips did leave residues in food.
Contacts by Dr. Zavon with Federal officials concerning DDVP
HEW records indicate that Dr. Zavon participated—presumably
as a consultant to Shell—in an April 1965 meeting concerning
DDVP
[p. 11]
with John S. Leary, Jr., two representatives of the Public
Health Service, and three Shell employees.
Shell Chemical Co. had formally objected to the November
1965 PHS Ad Hoc Committee study of vaporized pesticides, argu-
ing that the National Academy of Sciences (NAS) was the appro-
priate body to conduct such a study, if any were carried out. PHS
had also recommended referral of the matter to NAS when it sent
-------
1416 LEGAL COMPILATION—PESTICIDES
a copy of the ad hoc committee report to USDA in September 1966.
In August 1966, supervisory responsibility for the PHS pesti-
cide program was transferred from Washington to the Communi-
cable Disease Center (CDC) in Atlanta. A CDC official had been
one of the two members of the ad hoc committee who favored
continued registration of DDVP strips; in advocating his minor-
ity position, he had stressed that effort devoted by CDC over a
period of years to promoting the use of insecticide vapors to
control disease-carrying insects might be nullified by action
against DDVP.
In December 1966, Dr. Zavon wrote an assistant surgeon gen-
eral about the report of the ad hoc committee. Dr. Zavon endorsed
DDVP "as a health officer" (he is an assistant health commis-
sioner for the city of Cincinnati) and suggested that the entire
matter of pesticide vaporizers be "re-viewed" by PHS with an
opportunity for those with experience with the devices to present
information concerning them. Dr. Zavon's letter—the only in-
stance known to the subcommittee in which a health officer wrote
PHS to endorse use of DDVP strips—did not mention his rela-
tionship with Shell Chemical Co.
Dr. Zavon serves as PRD consultant in meeting on DDVP
In June 1967, Dr. Zavon, in his capacity as a consultant to PRD,
participated in a Washington meeting with other PRD medical
advisors. The agenda for the meeting included safety questions
concerning lindane and DDVP strips; minutes of the meeting
indicated that these matters were discussed at some length but
that no recommendations for action were made. Dr. Zavon's travel
expenses for the meeting were paid by USDA.
Agreement with PHS on DDVP warning
Dr. Zavon, who had served as a medical officer in the Public
Health Service from 1950 to 1957, was in frequent contact with
Atlanta officials of the PHS pesticides program during the latter
part of 1967. According to information supplied by Shell Chemi-
cal Co., he was responsible for reaching an agreement with PHS
for withdrawal of that agency's objection to registration of DDVP
strips provided a warning was placed on the label against use in
rooms "continuously" occupied by infants and infirm individuals.
PHS records indicate the agreement was reached in September
1967.
PRD refuses to accept proposed labeling
Shell subsequently asked PRD to approve addition of the warn-
ing statement agreed to by PHS, but PRD advised Shell that
-------
GUIDELINES AND REPORTS 1417
inclusion of the word "continuously" was not acceptable. Shell
responded by withdrawing its request for a label change and sub-
mitting additional data which it contended established that the
warning was not needed. r .. 0,
LP- J-^J
Further contacts by Zavon with PHS
A memorandum in HEW files indicates that Dr. Zavon called
Atlanta to advise PHS officials there that a copy of the additional
data was being sent to them. According to the memorandum, the
reason given by Dr. Zavon for Shell's decision not to add the
warning statement was that Dr. Hays "did not see the need" for
revising the label; there is no indication in the memorandum that
Dr. Zavon mentioned PRD's insistence on a stronger warning
statement. The memorandum also indicates that Dr. Zavon asked
PHS officials to make "discreet inquiries" concerning the accuracy
of a report he had heard that the President's Office of Science
and Technology would review the problem of pesticide vaporizing
devices.
Zavon conference with PRD officials
An August 7, 1968, letter written by Shell Chemical Co. to Dr.
Harry Hays refers to a "recent conference" at which Dr. Zavon
reviewed scientific data on DDVP strips for Dr. Hays. Dr. Hays
told the subcommittee staff he did not remember whether Dr.
Zavon was present at the July 15 meeting in which Mr. Leary
participated, but that it was possible he might have been.
Shell agrees to relabel DDVP strips
After further demands by PRD that Shell add a warning
statement to the label of its DDVP strip, Shell finally agreed to
do so on January 8, 1969. On the same day, PRD medical consul-
tants met in New York to again consider safety questions relating
to lindane and DDVP strips. The group recommended cancellation
action against lindane products, but decided to reconsider ques-
tions relating to DDVP strips at a subsequent meeting.
Question concerning dieldrin
When Dr. Zavon was initially appointed to serve as -a consultant
in 1963, his job description indicated that he was to advise PRD
on problems involving the pesticide dieldrin. Shell Chemical Co.
is a basic producer of dieldrin, and had a number of registered
pesticide products containing that substance prior to and during
1963. The subcommittee investigation did not disclose whether
or not Dr. Zavon actually advised USDA, as a consultant, on any
matter involving dieldrin in which Shell had a financial interest.
-------
1418 LEGAL COMPILATION—PESTICIDES
Patent question
The subcommittee investigation disclosed that HEW announced
in 1955 that PHS research scientists had discovered a new insec-
ticide known as DDVP; the announcement stated that any domes-
tic manufacturer who wished to do so would be free to produce
DDVP. Despite these statements, however, Shell Chemical Co. now
claims exclusive patent rights to DDVP.
FINDINGS AND CONCLUSIONS
1. Until mid-1967, the USDA Pesticides Regulation Division
failed almost completely to carry out its responsibility to enforce
provisions of the Federal Insecticide, Fungicide, and Rodenticide
Act intended to protect the public from hazardous and ineffective
pesticide products being marketed in violation of the act.
[p. 13]
Prior to mid-1967, no effort was made to systematically remove
potentially hazardous or ineffective products from the market;
instead, only the amount of illegal product found at the single
location where a violative sample had been obtained was seized.
Not a single criminal prosecution had been initiated for more
than 10 years prior to mid-1967, despite evidence of repeated
violations by some shippers.
Notices of judgments obtained in seizure actions were not being
published, even though publication is required by law.
Significant improvements in PRD enforcement procedures have
been made since mid-1967.
In late 1967, after appointment of Lowell E. Miller as Assistant
Director for Enforcement, PRD began requesting manufacturers
to voluntarily recall violative products from the market.
Formal procedures for requesting recall action, to be followed
by multiple seizure action if necessary, were approved in May 1969.
Operating guidelines for referral of cases to the Department
of Justice have been established and an indictment has been
returned in a case so referred. A Prosecutions and Import Section
has been established to handle referral of cases; however, its staff-
ing—consisting of the part-time services of only one person at the
professional level—is obviously inadequate.
Publication of notices of judgment has been resumed.
2. Numerous pesticide products have been approved for regis-
tration over objections of the Department of Health, Education,
and Welfare as to their safety without compliance with required
procedures for resolving such safety questions.
The subcommitee investigation disclosed that HEW objected to
-------
GUIDELINES AND REPORTS 1419
proposed registrations for more than 1,600 pesticide products
during the 5-year period ending June 30,1969.
Many, if not most, of these products were registered for uses
to which HEW had objected. The exact number is not known
because PRD does not keep records of products registered over
HEW objections and has failed or even refused to inform HEW
of action taken with respect to its objections.
The subcommittee investigation disclosed that PRD was, in
effect, demanding that HEW supply scientific proof of hazard to
support its objections, rather than asking the would-be registrant
to resolve any doubt by providing adequate evidence of the prod-
uct's safety.
Although a 1964 interdepartmental agreement requires that
unresolved HEW objections be referred to the Secretary of Agri-
culture for determination before a registration is approved, not
one of the more than 1,600 HEW objections was so referred. A
task force headed by the present PRD Director noted in a 1965
report that PRD was not complying with the agreement, but no
action was taken to correct the matter.
3. The Pesticides Regulation Division has approved pesticide
products for uses which it knew or should have known were prac-
tically certain to result in illegal adulteration of food.
The subcommittee investigation disclosed that PRD has regis-
tered or reregistered products such as lindane vaporizers or DDVP
strips for use in restaurants or other food-handling establish-
ments despite r 1.,
evidence that such uses would leave residues on food and despite
the fact that other Federal agencies refused to permit use of the
products in food-handling establishments.
Pesticide residues on food in interstate commerce constitute
adulteration, unless a tolerance has been issued for such residues
by the Food and Drug Administration. In the above instances, no
such tolerances had been issued or even applied for. Moreover,
FDA's authority to issue a tolerance for addition of a pesticide
to prepared food in restaurants is questionable.
4. The Pesticides Regulation Division has failed to take adequate
precautions to insure that pesticide product labels approved for
registration clearly warn users against possible hazards associated
with such products.
Examination of a relatively small number of pesticide products
labels during the subcommittee investigation disclosed several
instances where warning statements and directions for use on the
same label were confusing or even directly contradictory. At least
-------
1420 LEGAL COMPILATION—PESTICIDES
one instance where a misleading effectiveness claim has been
approved and widely used was also found.
Preliminary results of a study being made under a contract with
PRD indicate that most pesticide users do not read labels and
those who do have difficulty understanding them.
5. Information available to Federal agencies concerning pesti-
cide poisonings is inadequate and incomplete. The Pesticides Reg-
ulation Division has failed to make effective use of even the
limited data available.
According to its Director, the Pesticides Regulation Division
has placed considerable reliance on accident reports as a means
of detecting dangerous pesticide products. During 1968, PRD
received reports of 52 pesticide poisoning incidents involving a
total of 163 persons, a figure characterized as representing a fair
share of all pesticide poisonings.
The subcommittee investigation disclosed that the reports re-
ceived by PRD were actually only a tiny fraction of the approxi-
mately 5,000 pesticide poisoning cases reported annually to HEW,
even though the reports received by HEW were estimated to re-
flect only one of every eight or 10 pesticide poisonings actually
occurring.
The subcommittee found no evidence that PRD has made any
systematic use of the HEW reports; in fact, PRD's Director was
not even aware of the volume of reports received by HEW.
6. The Pesticides Regulation Division did not take prompt or
effective cancellation action in cases where it had reason to believe
a registered product might be ineffective or potentially hazardous.
Although PRD has had specific cancellation authority for more
than 5 years, it has never secured cancellation of a registration in
a contested case.
The subcommittee investigation disclosed evidence of lengthy
and unwarranted delays in initiating cancellation action after
facts sufficient to justify such action became known to PRD.
Until a few weeks ago, PRD did not even have procedures for
conducting hearings or studies which registrants may request as
a matter of right before cancellation action can become effective.
When r - _,
[p. 15]
registrants receiving cancellation notices requested hearings or
studies, prosecution of the cancellation action was halted and the
product left on the market.
A mistaken belief that positive evidence of hazard—rather than
simply a lack of adequate assurance of safety—is necessary to
support a cancellation action appears to have been a factor in
-------
GUIDELINES AND REPORTS 1421
PRD's failure to initiate such action in cases where it was obvi-
ously justified.
Cancellation action against a number of products has been
initiated during the subcommittee's investigation.
7. The Pesticides Regulation Division has consistently failed to
take action to remove potentially hazardous products from mar-
keting channels after cancellation of a pesticide registration or
through suspension of a registration.
Although PRD has never secured cancellation of a registration
in a contested case, there have been instances where registrations
of potentially hazardous products have been canceled by consent
or through failure of the registrant to contest the action. The
subcommittee investigation disclosed that PRD has no procedures
for taking action to remove such products from the market after
cancellation of the registration or even for notifying the Enforce-
ment Branch that the registration has been canceled.
PRD has no procedures or criteria for determining when a
registration should be suspended on the ground that a product
constitutes an "imminent hazard" to the public. Such action has
been taken only once; but a product containing an identical
amount of the same active ingredient was allowed to remain on
the market without even bearing a required warning notice on
its label.
In some cases, hazardous products were deliberately allowed to
remain on the market after cancellation of registrations.
8. The Pesticides Regulation Division has no procedures for
warning purchasers of potentially hazardous pesticide products.
Although removal of dangerous pesticides from marketing chan-
nels obviously does not protect buyers who already have the prod-
uct in their homes, PRD has not procedures for issuing warning
notices to the public when it becomes aware of possible hazards
from particular pesticide products. By contrast, other units of
the Agricultural Research Service apparently have procedures
for warning against possible hazards to animals from regulated
products which have already been sold.
PRD has recently issued warning notices concerning several
pesticide products discussed during subcommittee hearings.
9. The Agricultural Research Service failed to take appropriate
precautions against appointment of consultants to positions in
which their duties might conflict with the financial interests of
their private employer. Facts disclosed by the subcommittee inves-
tigation raised a number of serious conflict of interest questions.
Although Shell Chemical Co. is one of the country's largest
-------
1422 LEGAL COMPILATION—PESTICIDES
producers of registered pesticide products, Dr. T. Roy Hansberry,
an official of one of the company's affiliates, was appointed to a
1965 task force examining criteria used by PRD in determining
whether pesticide registration applications should be approved.
Before the appointmerx was made, an individual in the ARS
Personnel Division
[p. 16]
(whom ARS officials report they have been unable to identify)
certified on Dr. Hansberry's personnel clearance form that the
agency did not know of any official business with his private
employer which might constitute a conflict of interest.
Minutes kept by the task force's executive secretary are avail-
able for only one of its meetings; they indicate that he reminded
the group of legal restrictions on disclosure of confidential infor-
mation which should be kept in mind in view of Dr. Hansberry's
association with a private firm. The executive secretary was sub-
sequently dismissed by the task force chairman, and no further
minutes were kept.
Dr. Mitchell R. Zavon, a medical consultant to Shell Chemical
Co., served simultaneously as a consultant to the Pesticides Regu-
lation Division. Documents examined by the subcommittee indi-
cate that Dr. Zavon was actively concerned as a Shell consultant
in scientific studies and in negotiations with Federal agencies
relating to Shell's DDVP strip. The subcommittee investigation
also disclosed that Dr. Zavon participated as a PRD consultant
in a meeting at which safety questions relating to DDVP strips
were discussed, but no action was recommended.
USDA records indicate that Dr. Zavon was originally appointed
for the specific purpose of advising PRD on problems relating
to Dieldrin, a pesticide produced by Shell Chemical Co. The sub-
committee investigation did not disclose whether or not Dr. Zavon
actually advised USDA, as a consultant, on any matter involving
Dieldrin in which Shell had a financial interest.
Registration of Shell's DDVP strip was originally approved in
1963 after John S. Leary, Jr., then PRD's Chief Staff Officer for
Pharmacology, overruled an objection raised by a subordinate. In
November 1966, Mr. Leary gave notice that he was leaving PRD
to accept employment with Shell Chemical Co. In December 1966,
before leaving PDR, Mr. Leary recommended that PRD ignore a
Public Health Service report opposing continued sale of DDVP
strips. In 1968, as a Shell employee, Mr. Leary participated in a
meeting at which Shell opposed addition of a warning notice to
the label of its DDVP strip.
-------
GUIDELINES AND REPORTS 1423
In view of the conflict of interest questions raised by the sub-
committee investigation, the matters involving Dr. Hansberry, Dr.
Zavon, and Mr. Leary have been or are being referred by USDA
to the Department of Justice.
RECOMMENDATIONS
1. In view of the long-continued and serious deficiences which
have been disclosed in administration of the Federal Insecticide,
Fungicide, and Rodenticide Act by the USDA Pesticides Regula-
tion Division, the committee recommends that the Secretary of
Agriculture conduct a thorough review of PRD operations for
the purpose of—
(a) Making certain that the administrative deficiencies
discussed in this report (and any others found to exist) are
promptly corrected;
(b) Insuring that the Pesticides Regulation Division is
staffed by supervisory officials with sufficient qualifications,
experience, and administrative ability to prevent any repeti-
tion of such deficiencies;
[p. 17]
(c) Taking any necessary steps to insure that there are
adequate operating procedures and guidelines for all phases
of PRD operations.
The committee further recommends that USDA officials at the
highest levels and the General Accounting Office maintain close
surveillance over future operations of the Pesticides Regulation
Division.
It is the committee's understanding that action has been or is
being taken to correct at least some of the deficiencies described in
this report, and that the USDA Office of Inspector General is
examining some phases of PRD operations at the present time.
Committee recommendations concerning specific aspects of
USDA operations follow.
2. The committee recommends that USDA take prompt action
to make certain that pesticide products are not registered or
reregistered unless there is adequate assurance that they are safe
and effective.
The committee particularly recommends that such steps as are
necessary be taken to insure effective and unreserved cooperation
by the Pesticides Regulation Division with the Department of
Health, Education, and Welfare and other agencies concerned
with the safety and effectiveness of pesticide products. Immediate
action should be taken to make certain that unresolved safety
-------
1424 LEGAL COMPILATION—PESTICIDES
questions raised by HEW or the Department of Interior concern-
ing products proposed for registration are referred to the Secre-
tary of Agriculture, and that the provision of the interdepart-
mental agreement referring to furnishing of scientific evidence
not be misconstrued as in any way shifting the burden of proof
of safety away from the would-be registrant. Appropriate steps
should be taken to insure that any proposed pesticide uses which
may result in residues on food are reviewed by the Food and
Drug Administration.
Policies and procedures with respect to label review should be
strengthened, with a view to obtaining the maximum practicable
assurance that all labels approved in the future contain directions
for use which incorporate all necessary warning statements, use
format and language which will be as clearly readable and under-
standable as possible, and do not contain misleading effectiveness
claims.
Any necessary action should be taken to make certain that all
USDA personnel concerned with pesticide registration activities
fully understand that the safety of a pesticide product must be
established before it can be registered and that the burden of
proving a product's safety rests with the would-be registrant.
3. The committee recommends that the pesticides regulation
division review, as soon as feasible, all current pesticide registra-
tions in order to identify and take appropriate action with respect
to any registered products which—
(a) Bear inadequate, misleading, contradictory or confus-
ing labeling;
(b) Were approved without resolution of safety questions
raised by HEW;
(c) Make unjustified effectiveness claims;
(d) Are approved for uses likely to result in adulteration
or contamination of food. r ., 0,
[p. 18]
4. The Committee recommends that USDA take prompt action
to improve its present arrangements for obtaining data concern-
ing pesticide poisonings.
The committee specifically recommends that USDA take steps
to obtain and analyze, on a current basis, all useful information on
pesticide poisonings reasonably available from HEW poison con-
trol centers and other Government agencies. The committee further
recommends that USDA work with other Government agencies
toward improving the amount and usefulness of pesticide poison-
ing data available.
5. The committee recommends that USDA take appropriate
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GUIDELINES AND REPORTS 1425
steps to insure that cancellation proceedings are promptly initiated
whenever a reasonable question as to the safety of a registered
product becomes apparent.
The committee further recommends that USDA provide such
additional legal and other assistance to the Pesticides Regulation
Division as may be necessary to handle the present backlog of can-
cellation cases and to insure that PRD's recently adopted rules and
procedures for cancellation actions are adequate.
6. The committee recommends that USDA take necessary action
to provide better protection for the public against potentially haz-
ardous pesticides in marketing channels.
The committee specifically recommends that appropriate criteria
for determining when to suspend a product registration to prevent
"imminent hazard" to the public be established without delay and
that adequate procedures to insure uniform application of such
criteria be adopted.
The committee further recommends that procedures be estab-
lished to insure that the PRD enforcement branch is notified of
cancellations of registrations and that immediate action is taken
to remove potentially hazardous products from marketing channels
when registrations are cancelled. In particular, it recommends that
the Secretary take whatever action may be necessary to provide
positive assurance that officials of the Pesticides Regulation Di-
vision do not deliberately allow illegal and potentially hazardous
products to remain on the market in the future.
In addition, the committee recommends that USDA establish
procedures for issuance of warning notices to purchasers when it
receives information indicating that a pesticide product may be
potentially hazardous to users.
7. The committee recommends that USDA take such action as
may be necessary to insure that individuals are not appointed to
serve as employees of the Department under circumstances in
which their personal financial interests or those of their private
employer may conflict with their official duties. The committee
further recommends that added precautions be taken to prevent
violation of conflict of interest laws or regulations by employees
or former employees.
The committee specifically recommends that USDA strengthen
its procedures for clearing special Government employees from a
conflict of interest standpoint. Responsibility for clearing each
such appointment should be assigned to a specific individual whose
identity is made a matter of record. In addition to being familiar
with Federal conflict of interest laws and regulations, individuals
-------
1426 LEGAL COMPILATION—PESTICIDES
authorized to grant clearances should also have full knowledge of
the governmental .- ., „-,
duties and private financial interests involved. If it appears that
a possible conflict of interest is involved, the appointment should
not be made; if exceptional circumstances are deemed to justify
an exception, legal requirements for exempting an employee from
the conflict of interest laws should be carefully observed.
The committee further recommends and specifically requests
that USDA make a detailed and searching investigation of the cir-
cumstances involved in appointment of Dr. Hansberry to the 1965
task force, including the name(s) of the person or persons respon-
sible for clearing the appointment, and make a full report to the
committee on its findings. In addition, the committee recommends
that USDA review the duties and financial interests of all individu-
als now on its rolls as special Government employees to determine
whether any actual or potential conflicts of interest exist.
In instances where USDA employees, including special Govern-
ment employees, have financial interests in organizations doing
business with USDA, the committee recommends that the persons
responsible for supervising their work be informed of such inter-
ests and instructed to avoid assigning such employees to any duties
which could result in or give the appearance of creating a conflict
of interest. USDA officials should be specifically warned against
permitting former employees to represent private firms in connec-
tion with matters in which such former employees participated
personally and substantially as USDA employees. USDA officials
should also be instructed to carefully screen work assignments of
employees who have accepted or are negotiating for employment
with outside organizations to avoid possible conflicts of interest.
When matters relating to pesticide registrations or cancellations
are referred to advisory committees appointed by the National
Academy of Sciences, the committee recommends that USDA take
appropriate action to insure that members of such committees meet
the same standards with respect to conflicts of interest as would
be required of Federal employees.
The committee further recommends that USDA take adequate
precautions to insure that adequate records, including minutes of
meetings, are kept concerning the work of advisory groups whose
members are not all full-time Government employees.
8. The committee recommends that USDA take appropriate ac-
tion to provide additional personnel for the prosecutions and
imports section of the Pesticides Regulation Division's Enforce-
ment Branch.
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GUIDELINES AND REPORTS 1427
BACKGROUND
FEDERAL REGULATION OF PESTICIDES
Background
Since 1947, the Federal Insecticide, Fungicide, and Rodenticide
Act1 (FIFRA) has provided for regulation of marketing of pesti-
cides in interstate commerce. The act requires that all pesticides
must be registered with the Department of Agriculture before
they can be shipped in interstate commerce. Before a pesticide can
be registered, evidence must be presented to show that it is safe and
effective when used as directed. Responsibility for administering
the provisions of the act has been assigned by the Department of
Agriculture to the
[p. 20]
Pesticides Regulation Division (PRD), a unit of the Agricultural
Research Services (ARS).
Certain provisions of the Federal Food, Drug, and Cosmetic Act,2
after which FIFRA is patterned, also directly affect the regulation
of pesticides. This act is administered by the Food and Drug Ad-
ministration (FDA), Department of Health, Education, and Wel-
fare (HEW).
Pesticides or "economic poisons" covered by FIFRA include all
substances or mixtures of substances intended for—
* * * preventing, destroying, repelling, or mitigating any
insects, rodents, nematodes, fungi, weeds, and other forms of
plant or animal life or viruses, except viruses on or in living
man or other animals * * *
As defined in the act, as amended, the term "economic poison" also
includes any substances intended for use as plant regulators, de-
foliants or dessicants.
According to USD A, more than 45,000 products made from one
or more of some 900 chemical compounds are currently registered
under the act. These include not only products used to combat
weeds, insects, rodents and plant diseases, both on the farm and
around the home, but chemicals used for sterilizing and disinfect-
ing surgical instruments and restaurant equipment. Sales of regis-
tered pesticides are estimated at more than a billion dollars annu-
ally. Approximately half the registered pesticides are designed for
nonfarm uses, although those sold for agricultural use account for
the largest sales volume. The Department of Agriculture regards
11 U.S.C. 135-135k, hearing, record, appendix, p.248.
2 21 U.S.C. 301.
-------
1428 LEGAL COMPILATION—PESTICIDES
agricultural pesticides as so important that it has estimated crop
and livestock production would drop 25 to 30 percent if no pesti-
cides were used.
Statutory authority for pesticides regulation
The basic purpose of FIFRA is to insure that pesticides shipped
and held for sale in interstate commerce are safe and effective. The
act authorizes and directs the Department of Agriculture to refuse
to register a product if it does not appear to warrant the claims
made for it. The act prohibits interstate shipment of pesticides
which are not registered. It also prohibits interstate shipment of a
registered pesticide if any of the claims made for it or any of the
directions for its use differ in substance from the representations
made in connection with its registration. In addition, the act pro-
hibits interstate shipment of a pesticide if the composition differs
from its composition as represented in connection with its registra-
tion.
Economic poisons which contain any substance in quantities
highly toxic to man cannot legally be shipped in interstate com-
merce unless the label bears the skull and crossbones, the word
"Poison" in red on a background of a distinctly contrasting color,
and a statement of the antidote for the poison.
The act further prohibits the interstate shipment of pesticides
which are adulterated or misbranded. Under the act, an economic
poison is "misbranded" if its labeling bears any statement relative
to it or its ingredients which is false or misleading in any particu-
lar ; if it is an imitation of or offered for sale under the name of
another economic poison; or if its labeling does not contain direc-
tions for use and warning or caution statements adequate if com-
plied with to prevent injury and protect the public. A pesticide is
also misbranded under the act if
[p. 21]
any required statement is not prominently displayed on its
labeling in such terms as to be read and understood by the ordin-
ary individual under customary conditions of purchase and use;
or if it is injurious to living man or other vertebrate animals when
used as directed or in accordance with commonly recognized
practice.
The registration of any economic poison may be canceled at the
end of 5 years, and at the end of each additional 5-year period
thereafter, unless the registrant requests that it be continued. A
registration may be canceled at any time if it does not appear that
the product or its labeling complies with the provisions of the act;
the cancellation must be carried out in accordance with procedures
-------
GUIDELINES AND REPORTS 1429
specified in the act and becomes effective, if not contested, 30 days
after notice. The registration on an economic poison may be sus-
pended immediately when the Secretary finds that such action is
necessary to prevent an imminent hazard to the public. The regis-
trant must then be given an opportunity to oppose the suspension,
but the product cannot legally be sold until the matter is resolved.
Economic poisons imported mto the United States are subject to
the provisions of FIFRA. However, products intended solely for
export and prepared or packed according to the specifications or
direction of the foreign purchaser are not subject to the act.
Any person violating provisions of the act may be fined for his
first offense and fined, imprisoned (for not more than 1 year) or
both for each subsequent offense occurring not more than 5 years
after the last previous conviction. If criminal prosecution is con-
templated because it appears from an examination of an economic
poison that the product does not comply with the requirements of
the act, notice and an opportunity to present his views must first
be given to the person against whom such prosecution is contem-
plated.
The Department of Agriculture is authorized by the act to insti-
tute court proceedings for seizure and appropriate disposition of
economic poisons in interstate commerce which are adulterated,
misbranded or unregistered. Manufacturers, distributors, carriers,
and sellers of economic poisons subject to the act are required to
allow access to shipment records to authorized personnel of the
Department of Agriculture, although specific evidence obtained in
this manner may not be used in a criminal prosecution against the
person from whom obtained.
The Department of Agriculture is not required to initiate crim-
inal prosecutions or seizure proceedings for minor violations of
the act when it believes the public interest will be adequately
served by a suitable written notice of warning. The act requires
the Department to publish notices of all judgments in actions in-
stituted under its authority.
While FIFRA covers only economic poisons in interstate com-
merce, almost all States have generally similar registration laws
applicable to pesticides distributed within the State.
The pesticide chemical and food additive amendments to the
Federal Food, Drug, and Cosmetic Act provide that a tolerance
must be established by the Food and Drug Administration in the
event a registered use of an economic poison will result in residues
on or in food and feedstuffs.
[p. 22]
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1430 LEGAL COMPILATION—PESTICIDES
ARS PESTICIDES REGULATION DIVISION
Organization of Pesticides Regulation Division
The Agricultural Research Service was established in 1953 to
consolidate most of the physical, biological, chemical, and engineer-
ing research carried out by the Department of Agriculture within
a single organization. Agricultural Research Service also is re-
sponsible for a number of regulatory programs, including pesti-
cides regulation. Pesticides regulation activities are assigned to
the Pesticides Regulation Division.
According to an organization chart supplied by PRD,3 Division
personnel are assigned to two branches—one for registration and
one for enforcement—and five separate staffs performing special-
ized functions.
The registration branch handles administrative details, corre-
spondence and records relating to registration applications and
cancellation proceedings. Product evaluation staffs are responsible
for making final decisions, within the guidelines of division policy
and criteria, concerning approval of applications or cancellation of
registrations. Separate product evaluation staffs are established to
deal with disinfectants, fungicides, insecticides, herbicides, and
plant growth regulators, and rodenticides.
The enforcement branch is responsible for planning, directing,
and coordinating with other Federal and State programs the field
activities necessary to effectively regulate the marketing of pesti-
cides. These include accident investigations, inspection and sam-
pling of products in marketing channels, laboratory analysis of
product samples, seizure and recall action, and preparing infor-
mation necessary to initiate criminal prosecutions.
The other four staff groups whose responsibilities are described
in the organization charts are the regulation and interpretation
staff, the interagency coordination staff, the new chemicals evalu-
ation staff, and the pesticides safety advisory staff.
Registration procedures and operations
The following description of registration procedures used by
the Pesticides Regulation Division was supplied by PRD: *
Before a product can be registered, the manufacturer or
formulator must file a formal application, submit five copies
of the proposed labeling, a statement of complete chemical
composition of the product, and extensive data on both effi-
cacy and safety.
8 Hearing record, p. 297.
* Hearing record, p. 241.
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GUIDELINES AND REPORTS 1431
The new chemicals evaluation staff first reviews the label
for accuracy of chemical composition, ingredient statement,
net contents, chemical nomenclature, and product name.
The product evaluation staff, made up of specialists in en-
tomology, plant pathology, agronomy, bacteriology, and ani-
mal biology, reviews the labels and data for effectiveness.
Among the criteria used are the pests to be controlled, dosage
and rate of application, soil persistence, metabolism, phyto-
toxicity, migration, translocation, and method of application.
[p. 23]
The pesticides safety evaluation staff reviews the toxico-
logical data with respect to safety to man, fish, and wildlife,
and other beneficial animals. The principal criteria used in
the safety evaluation are the results of acute oral, dermal,
and inhalation studies, subacute feeding studies, eye and skin
irritation, sensitization, neurotoxicity, reproduction, and car-
cinogenic studies. On the basis of the data, it can be deter-
mined whether the front panel of the label shall carry the
signal word "Danger," "Warning," or "Caution," and what
precautionary statements are necessary, which, if complied
with, are adequate to prevent injury to living man and other
vertebrate animals, vegetation, and useful invertebrate
animals.
If the product is to be used on food or feed, careful con-
sideration is given to residues that are likely to occur from
such use and in which case the matter is referred to the
Food and Drug Administration for establishing a tolerance.
After the scientific review has been completed, the applica-
tion is again reviewed in its entirety to determine if the
product is acceptable for registration. If data are inadequate,
the applicant is so advised and registration is withheld until
all requirements have been satisfied. If it appears that regis-
tration is in order, the label and data are referred to the
Department of the Interior and/or the Department of Health,
Education, and Welfare as provided for under the interde-
partmental agreement. The purpose of this agreement is to
give the other departments an opportunity to advise the De-
partment of Agriculture of any changes in labeling that
might be necessary to further protect the public, or to protect
fish and wildlife. Our scientists are in day-to-day communi-
cation with HEW and Interior.
During fiscal year 1968, according to its records, the Pesticides
Regulation Division accepted nearly 5,000 new products for regis-
-------
1432 LEGAL COMPILATION—PESTICIDES
tration and processed almost 11,000 amendments to labels of pre-
viously registered products. (Labels of registered products are
amended because of new patterns of use or minor changes in for-
mulation or precautionary statements.) During the same period,
about 10,000 pesticide labels were reviewed by the Public Health
Service (PHS) and around 4,500 by the Department of the Inte-
rior. All labels for new products were referred to PHS for review;
however, amendments to labels were not usually so referred if no
safety question was believed to be involved.
The Department of Interior reviewed labels for pesticide uses
which might affect birds, animals, and fish and their habitats,
but did not review those involving only household uses.
As of mid-1969, about 105 employees of the Pesticides Regula-
tion Division were assigned to duties relating to the registration
of pesticide products. About 60 of these worked directly under
the Office of the Director or were assigned to product evaluation
staffs, with the remainder working in the registration branch.
Enforcement procedures and operations
The basic objective of Pesticides Regulation Division enforce-
ment activities is to insure that pesticide products being marketed
in interstate commerce meet the standards required for regis-
tration and sale.
[P. 24]
For this purpose, PRD inspectors inspect and sample pesticides
in warehouses and sales outlets throughout the United States.
Pesticide labels are examined to ascertain whether the product is
registered and whether the information contained on the label is
adequate. Samples of pesticides are sent to PRD laboratories for
analysis to determine whether the product contains all ingredients
listed on the label in the amounts listed and whether or not the
product is adulterated with chemicals or other materials not
listed on the label. Results of laboratory analysis of samples are
forwarded to Washington, where Enforcement Branch personnel
determine what further action should be taken with respect to
those results indicating violations.
As of mid-1969, the PRD Enforcement Branch had 5 super-
visory inspectors and 26 field inspectors stationed at about 20
locations throughout the United States.
The Pesticides Regulation Division has five chemistry labora-
tories staffed by a total of five supervisory chemists and 27 other
chemists, as well as nontechnical personnel. These laboratories
analyze samples to determine their composition and the presence
of adulterants. In addition, PRD has seven laboratories which
-------
GUIDELINES AND REPORTS 1433
perform biological testing related to safety and effectiveness.
These consist of two plant biology laboratories, two entomology
laboratories, a pharmacological laboratory, an animal biology
laboratory and a bacteriological laboratory. These are staffed
by seven supervisors and 17 other professionals. During fiscal
year 1968, the chemistry laboratories tested 5,219 samples and
the biological laboratories tested 2,737.
The Pesticides Regulation Division has cooperative agreements
with about half the States and informal working arrangements
with a number of cities. Under the cooperative agreements, State
inspectors can, upon request, collect samples, obtain records of
interstate shipment, and ship samples to Federal laboratories.
ENFORCEMENT ACTIVITIES
Failure to remove illegal products from market
On September 10, 1968, the Comptroller General issued a report
to the Congress on "Need to Improve Regulatory Enforcement
Procedures Involving Pesticides." 5 The report was based on a
review by General Accounting Office personnel of enforcement
actions initiated by the Pesticides Regulation Division during
fiscal year 1966 and related events occurring before and after
this period. The report clearly showed that PRD procedures for
removal from the market of hazardous or ineffective pesticide
products being sold illegally were, as of mid-1967, almost totally
inadequate.
The GAO report did not criticize the manner in which samples
of pesticide products were collected and analyzed to determine
whether the products complied with provisions of the Federal
Insecticide, Fungicide, and Rodenticide Act. According to the
report, PRD tested and reviewed 2,751 samples of pesticide prod-
ucts in fiscal year 1966. Of these, 750 were found to be in viola-
tion of the act; 188 of the 750 violations were determined by PRD
to be minor, requiring only a written notice of warning to the
registrant rather than seizure or criminal pros-
r
LP.
ecution. The other 562 samples — about 20 percent of all those tested
and reviewed — were considered to be in major violation of the act.
Although the act authorizes PRD to obtain information con-
cerning the location of pesticide products from the shipping rec-
ords of manufacturers, distributors, carriers and dealers, the
GAO review showed that PRD did not have procedures or stand-
ards for obtaining such information. GAO found that generally
* Hearing record, appendix, p. 141.
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1434 LEGAL COMPILATION—PESTICIDES
it was PRD practice to remove from the market only the amount
of product, if any, found at the one retail or wholesale outlet
where the sample was collected, without any attempt to deter-
mine whether additional quantities of the violative products were
in marketing channels at other locations. According to the report,
106 seizure actions were taken in fiscal year 1966; however, 22 of
these did not result in removal of any quantity of pesticide prod-
ucts from the market because the product was no longer on the
shelves at the location where the sample had been taken. The other
84 seizure actions, involving 79 different products, affected only
80 different wholesale or retail outlets.
The GAO report cited a graphic example of failure by PRD to
effectively remove a dangerous illegal product from the market.
According to the report, registrations of 58 products containing
the chemical thallium were canceled as of the end of August 1965.-
The cancellations took place because the use of thallium for the
control of insects and rodents had resulted in a large number of
poisonings; statistics of the Public Health Service indicated that
there were about 400 reported cases of thallium poisoning of
children in 1962 and 1963. Despite the cancellations, the report
disclosed, products containing thallium were found in six of 22
retail establishments visited in the Washington area in late 1967
—more than 2 years later.
The GAO findings concerning removal of illegal products from
the market contrasted sharply with a claim by the Department
of Agriculture that—
Aggressive enforcement action to take * * * dangerous pes-
ticides off the market has been a significant part of the pro-
tection being given the public * * *.«
Thirteen-year failure to prosecute
In addition to criticizing PRD procedures for removing illegal
pesticide products from the market, the September 1968 GAO
report also criticized the Pesticides Regulation Division for fail-
ing to take effective action to initiate prosecution of those re-
sponsible for placing the illegal products on the market.
According to the report, during the fiscal year 1966 PRD noti-
fied 242 shippers of pesticide products that criminal proceedings
were contemplated against them. The notifications were based on
456 samples of pesticide products considered by PRD to be in
major violation of the Federal Insecticide, Fungicide, and Roden-
« The Yearbook of Agriculture, 1966. p. 279.
-------
GUIDELINES AND REPORTS 1435
ticide Act, each of which was regarded as evidencing a separate
violation of the act. One hundred sixty-five of the 242 shippers
were responsible for only a single violative sample; the other 77
had shipped a total of 291. One hundred thirty-four violative
samples—nearly 30 percent of the total—were shipped by 17
firms, each of which had shipped five or more. Two firms were
responsible for 20 violative samples each.
[P. 26]
The General Accounting Office found, in its report, that PRD
did not have established procedures for determining under what
circumstances evidence of violations of the act would be reported
to the Department of Justice for prosecution. The GAO also found
that, despite evidence of repeated violations by some shippers,
not a single case of alleged violations of the act was reported to
the Department of Justice for prosecution during the 13-year
period from February 1955 through February 1968. The report
further noted that the complete absence of prosecutions occurred
despite the fact that some shippers simply ignored notices of con-
templated proceedings and made no attempt to explain apparent
serious violations disclosed by samples.
Failure to publish notices of judgments
Section 6(e) of the Federal Insecticide, Fungicide, and Roden-
ticide Act requires that the Secretary of Agriculture give notice
by publication of all judgments entered in actions instituted
under the authority of the Act. The GAO found that, from the
inception of FIFRA in 1947 to November 1964, 18 publications
summarizing the results of 515 judgments (primarily seizures)
had been issued at intervals averaging about 6 months. How-
ever, the GAO found, no publications had been issued from No-
vember 1964 through December 1967. During this period, the
report stated, there was an accumulation of about 250 judgments
which had not been published. The explanation offered for USDA's
failure to publish notices of these judgments, according to the
report, was that the employee assigned to compiling the infor-
mation necessary for publishing the notices had retired and had
not been replaced.
Testimony concerning GAO findings
During subcommittee hearings, Department of Agriculture
witnesses were asked whether they found any fault with the
September 1968 GAO report and a subsequent report issued in
February 1969. Dr. Robert J. Anderson, Associate Administrator
-------
1436 LEGAL COMPILATION—PESTICIDES
of the Agricultural Research Service, gave the following
responses:7
No, sir. On the contrary, we found these reports to be very
helpful to us in carrying out our responsibility in adminis-
tering the act.
USDA witnesses specifically confirmed GAO findings concern-
ing the lack of procedures for prosecution of violations of the act
and the failure of PRD to refer a single case to the Department of
Justice for prosecution over a 13-year period. They further ac-
knowledged that no notices of judgment had been issued during
a period of more than 4 years.8
Testimony at subcommittee hearings also supported GAO crit-
icism of PRD's failure to remove illegal pesticide products from
the market. Dr. Anderson admitted that, as of the end of 1966,
PRD policy was to seize only the quantity of illegal pesticide
products found at the location where the sample was taken;
there were no procedures for records examinations to locate addi-
tional quantities of illegal products or multiple seizures to remove
them from distribution channels.9
Subcommittee hearings also established that existing stocks of
rat poison containing thallium had deliberately been left on the
market [p 27]
after registrations for such use had been cancelled because
of the large number of injuries and deaths—mostly involving
children—caused by thallium. PRD took action in June 1960 to
limit the amount of thallium which could be used in an attempt
to reduce the possibility of fatal accidents involving such prod-
ucts; however, deaths continued to occur. All registrations for
thallium products were finally cancelled effective August 31, 1965,
but the Department of Agriculture knowingly allowed continued
sale of products already on the market. Dr. Harry W. Hays, Direc-
tor of the Pesticides Regulation Division, stated that:10
We did not make any attempt to withdraw the materials
from the market on the premise * * * that the cancellation
would in itself prevent the continued proliferation and thus
a phasing out, a dilution and finally disappearance.
Dr. Hays was unable to tell the subcommittee how many deaths
had resulted from thallium or how many accident reports involv-
ing thallium had been received after 1963.
1 Hearing record, p. 6.
8 Hearing record, pp. 33-35.
0 Hearing record, p. 15.
10 Hearing record, p. 17.
-------
GUIDELINES AND REPORTS 1437
Dr. Anderson told the subcommittee that the Department of
Agriculture believed voluntary recalls by the manufacturer are
"* * * the most effective and efficient * * *" means for removing
violative products from the market. Questioning of USDA wit-
nesses established that no use of voluntary recalls had been made
from the enactment of FIFRA in 1947 until September 1967, a
situation Dr. Anderson attributed at first to "* * * lack of author-
ity in the act providing for the recall action." Under further
questioning, Dr. Anderson confirmed that voluntary recall pro-
cedures—which he described as "working quite well"—had been
instituted without necessity for enactment of any additional legal
authority.11
Improvement in enforcement procedures and operations
Significant improvements in PRD enforcement procedures and
operations were made after the appointment in mid-1967 of an
assistant director for enforcement, Lowell E. Miller.
In September 1967 according to testimony at subcommittee
hearings, PRD made its first request that a manufacturer volun-
tarily withdraw a violative product from the market. From July
1, 1968, through April 30, 1969, 32 such requests for voluntary
recalls were made. In a May 22, 1968, letter to the General
Accounting Office, the acting administrator of the Agricultural
Research Service stated that ARS would examine shipping rec-
ords to obtain product location data and make multiple seizures
in instances where manufacturers refused to recall violative
products from the market voluntarily. Formal recall procedures
were approved on May 5, two days before the subcommittee's
first hearing.12
In December 1967, a new Prosecution and Import Section was
created. The stated purpose of this section is—
* * * not only to establish more effective procedures for the
handling of prosecution but also to focus attention upon the
fact that prosecutions are an important part of the enforce-
ment program.
Operating guidelines for determining under what circum-
stances cases would be forwarded to the Department of Justice
for prosecution,
[p. 28]
which had not previously existed, were established in early 1968.
11 Hearing record, pp. 3, 7.
12 Hearing record, pp. 3, 6, 176.
-------
1438 LEGAL COMPILATION—PESTICIDES
The guidelines call for cases to be forwarded for prosecution
where—
* * * (1) the evidence indicates that the violation was
willful, (2) the violation is of a serious nature (e.g., signifi-
cant deficiency of active ingredient or contamination) and
is the result of apparent gross negligence, or (3) the com-
pany has engaged in repeated violations.13
Agricultural Research Service told the subcommittee that it
was now "* * * putting major emphasis on starting action against
repeat violators." The agency reported that the first criminal
indictment in at least 13 years alleging violation of the Federal
Insecticide, Fungicide, and Rodenticide Act had been returned
by a grand jury in Chicago in March 1969. Agricultural Research
Service further reported that two additional case files had been
forwarded to USDA's Office of General Counsel with a recom-
mendation for prosecution and that case files relating to alleged
violations of the act by approximately 20 companies were in
various stages of preparation.14
The subcommittee was assured that steps had been taken to
resume publication of notices of judgment and to provide for
regular publication of such notices in the future.15
Serious deficiencies remaining
Although subcommittee hearings indicated that significant
progress had been made in improving Enforcement Branch pro-
cedures and operations, they also disclosed that serious deficien-
cies remained.
In a May 22, 1968, letter to the General Accounting Office, Dr.
R. J. Anderson, acting administrator of the Agricultural Research
Service, stated that ARS agreed with GAO's belief that prosecu-
tions were necessary for a strong enforcement program. Dr.
Anderson further advised the General Accounting Office with
respect to the newly created prosecutions and imports section
that:16
This section became sufficiently staffed in January 1968 so
that work could be commenced on setting up procedures for
the handling of prosecutions. We are currently reviewing all
cases in the recent past to determine whether criminal prose-
cution should be recommended.
is Hearing record, p. 4.
1* Hearing record, p. 4.
15 Hearing record, p. 35.
18 Hearing record, p. 177.
-------
GUIDELINES AND REPORTS 1439
Testimony at a subcommittee hearing on May 7, 1969, disclosed
that the entire staff of the prosecutions and import section con-
sisted of one man at the professional level and one clerical assist-
ant. In addition to reviewing cases for possible prosecution, the
one professional also had responsibility for supervising all im-
ports of pesticides. The backlog of cases being reviewed for pros-
ecution was estimated at about 20, and PRD witnesses admitted
that more than 20 additional cases might be added to the back-
log before the current 20 had been reviewed.17
Subcommittee hearings also disclosed that there were no pro-
cedures for warning the general public about possible danger
when potentially hazardous pesticides were found in marketing
channels. In addition, while procedures for removing dangerous
products located by PRD inspectors appeared to be adequate, it
was found that there were no
[p.29]
procedures to insure that appropriate enforcement action was
taken after a registration was canceled because of a safety ques-
tion or lack of effectiveness. These matters are discussed in greater
detail in this report.
REGISTRATION ACTIVITIES
LINDANE
Failure to resolve safety questions relating to lindane
The September 1968 GAO report on enforcement procedures,
which led to the subcommittee investigation, was followed by a
second report on "Need to Resolve Questions of Safety Involving
Certain Registered Uses of Lindane Pesticide Pellets." 1S This
report was issued on February 20, 1969, after the subcommittee
investigation had been initiated.
In its report, the General Accounting Office found that the ARS
Pesticides Regulation Division had continued to register pellets
containing the chemical lindane for use in continuous vaporizing
devices in commercial and industrial establishments—such as
restaurants and other food handling businesses—even though
the Public Health Service and other Federal, State, and private
organizations had opposed this use over a long period of time.
According to the report, the initial registration of lindane pel-
lets for use in continuously operating vaporizing devices in com-
mercial and industrial establishments took place in 1950 or 1951
17 Hearing record, p. 34.
is Hearing record, appendix, p. 181.
-------
1440 LEGAL COMPILATION — PESTICIDES
without objection from the Public Health Service or the Food
and Drug Administration. In October 1952, the Interdepartmental
Committee on Pest Control, composed of representatives of the
Departments of Agriculture, Interior and Defense and the Fed-
eral Security Agency (predecessor to the Department of Health,
Education, and Welfare), recommended against the use of insec-
ticide vaporizers in rooms or areas where food is served, processed
or stored unless it could be demonstrated that contamination of
food did not occur. Thereafter, the report indicated, at least 14
States and 35 municipalities adopted measures to control the in-
stallation, sale or use of lindane vaporizers.
In 1953, according to the report, a copy of a letter from the
Secretary of Health, Education, and Welfare raising questions
concerning possible health hazards associated with the use of
lindane vaporizers was transmitted to ARS. Also in 1953, a study
by the Food and Drug Administration concluded that use of lin-
dane vaporizers around food resulted in contamination. The
study further concluded that food would not be protected from
such contamination by the use of common wrapping or covering
materials, except metal.
In spite of the questions raised concerning lindane, PRD con-
tinued to register and reregister lindane pellets for use in con-
tinuous vaporizing devices. By contrast, the unit of the Depart-
ment of Agriculture responsible for meat inspection — which was
also a part of the Agricultural Research Service at the time —
refused to permit the use of lindane vaporizers in meat process-
ing and slaughtering establishments.
In early 1964, an interdepartmental agreement intended to
coordinate activities relating to pesticides registration was signed
by the Secretaries of Agriculture, Interior, and Health, Educa-
tion, and Welfare. Under the agreement, proposed registrations
and reregistrations
r
Lp.
of pesticides were to be submitted by the Department of Agricul-
ture to HEW for review. The Public Health Service, which reviewed
proposed registrations for HEW from the standpoint of safety,
thereafter objected to registration of lindane pellets for use in
continuous vaporizers in food handling establishments. In 1965,
an ad hoc committee was appointed by the Bureau of State Ser-
vices, PHS, to review the use of pesticide vaporizing devices. The
committee's report, which expressed unanimous opposition to the
use of lindane vaporizers, was transmitted to ARS in September
1966.
In July 1967, according to the GAO report, a PRD inspector
called attention to what he regarded as contradictory labeling of
-------
GUIDELINES AND REPORTS 1441
lindane pellets, pointing out that one side of the label called for
use in restaurants, bars, and offices, while the other side warned
against inhalation and against contamination of food. The inspec-
tor was informed that the labeling he was questioning was sub-
stantially the same as that accepted for registration; apparently
no further action was taken.
Although the question of safety of lindane vaporizers had been
raised repeatedly, the General Accounting Office found that the
Pesticides Regulations Division had taken no action to resolve it.
The GAO report also noted that PRD apparently was acting on
the assumption that once a pesticide had been registered the
burden of proof was on PRD to establish that is was unsafe before
reregistration could be denied.
Belated action to stop sale of lindane
On November 27, 1968, after reviewing a draft of the GAO
report relating to lindane, the Department of Agriculture wrote
the General Accounting Office that:19
Information has recently come to our attention which indi-
cates the need for a reevaluation of the safety of lindane in
an uncontrolled environment. It has been shown that malnu-
trition greatly enhances the toxicity of lindane in laboratory
animals. Significant residue levels have also been found in
tissues of animals exposed to vaporized lindane. * * *
USDA advised GAO that ARS was arranging a meeting with
departmental representatives responsible for carrying out pro-
visions of the 1964 Interagency Agreement to determine what
steps should be taken concerning the problem of lindane vaporiz-
ers. USDA further advised GAO that a meeting was being
scheduled with medical experts who provide advice and counsel
to the Pesticides Regulation Division on matters relating to the
use of pesticides.
On April 29, 1969, some 2 months after public release of the
GAO report, USDA announced that it was initiating action to
cancel registrations of lindane products for use in vaporizing
devices "because of undue risk to the health of persons chroni-
cally exposed to the vapors." The USDA announcement further
stated that the "expansion of scientific knowledge since 1951"
had also raised serious doubts about the safe use of lindane in
areas where food is being processed or stored. According to the
announcement, studies initiated several months before and inten-
N> Hearing record, p. 216.
-------
1442 LEGAL COMPILATION—PESTICIDES
sified after publication of the GAO report had disclosed that prac-
tically all food, whether packaged or unpackaged, contained
[p. 31]
illegal residues after 5 days exposure to lindane under simulated
restaurant conditions.
Questionable excuses and misleading statements
In testimony before the subcommittee, ARS witnesses admitted
that the agency first became aware of objections by the Public
Health Service and the Food and Drug Administration to the use
of lindane vaporizers in 1953. However, they contended that the
agency's failure to act for some 16 years was necessitated by its
lack of scientific data establishing that such use of lindane was
hazardous. ARS witnesses also claimed that they had looked every-
where for such data, but had been unable to find it.20
USDA witnesses acknowledged in their testimony that, under
the law, the burden of establishing that a pesticide chemical is
safe rests upon the registrant. However, their testimony indi-
cated that when PRD was warned of possible health hazards
associated with use of lindane vaporizers, it disregarded this fact.
It further indicated that instead of calling upon the registrants
to submit additional evidence of safety, PRD acted as though it
was the responsibility of the Public Health Service to provide
scientific data proving that use of lindane vaporizers was danger-
ous before any action could or should be taken.21
Testimony of ARS officials suggested that the agency had made
vigorous efforts over a long period of time to obtain information
which might resolve questions concerning the safety of lindane
vaporizers. The record does not support this contention. ARS
did not bother to conduct laboratory tests (or require that such
tests be conducted by registrants) for almost 16 years after ques-
tions about lindane were raised by other Federal agencies. When
such tests finally were performed in February 1969, it took only
5 days to establish that use of lindane vaporizers under simulated
restaurant conditions would result in illegal residues on food.
The subcommittee investigation further disclosed that a copy of
a 1953 Food and Drug Administration study, which concluded
that the use of lindane vaporizers around food would result in
contamination, had been provided to ARS not long after it was
completed.
In its November 27, 1968, letter to the General Accounting
20 Hearing record, pp. 24-26, 29.
21 Bearing record, pp. 24-29, 67.
-------
GUIDELINES AND REPORTS 1443
Office, the Department of Agriculture indicated that ARS was
arranging a meeting concerning the lindane problem with medical
consultants and with departmental representatives responsible
for carrying out the interagency agreement on pesticides. USDA
further indicated that the meetings were being scheduled because
of information which had recently come to its attention relating
to residue levels in tissues of animals exposed to vaporized lin-
dane and to the effect of malnutrition on the toxicity of lindane
in laboratory animals. At subcommittee hearings, ARS witnesses
presented testimony apparently intended to imply that the re-
cently obtained information formed the primary basis for a con-
clusion by its medical advisers that use of lindane vaporizers con-
stituted an undue risk to the health of those continuously exposed
to the vapors.22 Further inquiry by the subcommittee disclosed
however, that the report prepared by the medical advisory panel
did not even mention the recently obtained information purport-
edly responsible for their consideration of the lindane problem.
Instead, the
[p. 32]
panel's report emphasized 1965 and 1967 articles describing a
possible relationship between the use of vaporized lindane and the
development of aplastic anemia in humans. An advance copy of
the 1967 article had been sent to and received by Harry W. Hays,
Director of the Pesticides Regulation Division, in February 1967.
The subcommittee investigation also disclosed that the lindane
problem had first been referred to PRD's medical advisory panel
in October 1966, more than 2 years before the November 1968
letter to GAO. In addition, the subcommittee found that the meet-
ing of departmental representatives referred to in the letter did
not take place until March 19,1969, and that minutes of this meet-
ing do not disclose any reference whatever to lindane.
CLAIMED IMPROVEMENT
In testimony before the subcommittee, witnesses from the Agri-
cultural Research Service acknowledged the existence of deficien-
cies in registration procedures in past years. However, they con-
tended that significant improvements had been made, attributing
much of the progress claimed to the work of a 1965 task force on
the pesticide regulation and the subsequent hiring of the task
force chairman, Dr. Harry W. Hays, as Director of the Pesticides
Regulation Division. Before joining PRD in mid-1966, Dr. Hays
22 Hearing records, pp. 6, 216-217.
-------
1444 LEGAL COMPILATION — PESTICIDES
had served for almost 10 years as Director of the Advisory Cen-
ter on Toxicology of the National Academy of Sciences-National
Research Council.
Dr. George W. Irving, Administrator of ARS, described the
work of the task force in his testimony and stated that: 2S
We are now in vastly better condition with respect to regis-
tration than we were prior to that time.
Dr. Robert J. Anderson, ARS's Associate Administrator, indi-
cated in his testimony that the appointment of the task force by
the Secretary of Agriculture marked the beginning of efforts to
strengthen administration of the Federal Insecticide, Fungicide,
and Rodenticide Act. Dr. Anderson told the subcommittee that,
after Dr. Hays became Director of PRD : 2*
We reorganized the Division, giving greater emphasis to
criteria of safety used in the registration process.
The report of the task force appears on pages 248-296 of the
hearing record. A statement concerning recommendations of the
task force and action taken to carry them out appears in the hear-
ing record on pages 48-50.
INTEEAGENCY COOPERATION
Interdepartmental agreement on coordination of activities
Under the Federal Insecticide, Fungicide, and Rodenticide Act,
basic responsibility for registration of pesticides is placed in the
Department of Agriculture. However, other Federal agencies have
significant responsibilities and interests involving registration of
pesticides. The Food and Drug Administration is required, under
the Federal Food, Drug, and Cosmetic Act, to establish a safe tol-
erance before pesticides can legally be registered for uses which
will result in residues on or in food or feedstuffs. The Public
Health Service is concerned about
r
[p.
the effect of pesticides on human health. The Department of the
Interior administers programs designed to protect fish and wild-
life from pesticide contamination.
In its May 15, 1963, Report on Use of Pesticides, the Presi-
dent's Science Advisory Committee recommended, among other
things, that:
The Secretaries of Agriculture, Interior, and Health, Edu-
cation, and Welfare review and define their roles in the regis-
28 Hearing record, p. 62.
Z* Hearing record, p. 14.
-------
GUIDELINES AND REPORTS 1445
tration of pesticides that are not present on food, but that
may impinge on fish and wildlife or come into intimate con-
tact with the public.
In response to the report of the President's Committee, the
Secretaries of the three departments signed a memorandum of
agreement for the stated purpose of "Coordination of activities
of the three departments pertaining to pesticides with special
reference to registration and the setting of tolerances * * *." The
first signature was affixed to the agreement on March 27, 1964;
the last one on April 8, 1964. (The full text of the agreement
appears in the hearing record on pp. 70-71.)
The agreement described the existing responsibilities of each
department as follows:
Department of the Interior
Fish and Wildlife Service.—Conserving beneficial wild birds,
mammals, fish, and their food organisms and habitat, with regard
to pesticides.
Department of Health, Education, and Welfare
U.S. Public Health Service.—Protecting and improving the
health of man in regard to pesticides.
Food and Drug Administration.—Establishing tolerances for
pesticides in or on raw agricultural commodities and processed
foods.
Department of Agriculture
Agricultural Research Service.—Providing for the safe and
effective use of pesticides, including the registration thereof.
The agreement provides for each of the three departments to
keep the others fully informed of knowledge about pesticides
which comes into its possession. It specifies that USDA is to fur-
nish the other departments with a weekly listing of all proposals
affecting registration and reregistration and that HEW is to
furnish a similar listing of proposals affecting tolerances. It fur-
ther provides that USDA and HEW respectively will, upon re-
quest, furnish to the other departments full information about
any pending action on registration or the setting of a tolerance.
The agreement also specifies that questions concerning any item
on the weekly listings are to be communicated to the originating
department within one week, stating the specific reason for need
for further review. The originating department is then required
to furnish the necessary information and make the necessary
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1446 LEGAL COMPILATION—PESTICIDES
arrangements for further review and to withhold final action on
the matter questioned for an additional 3 weeks.
If one department concludes that a proposal should be rejected
in whole or in part, the agreement provides for the objection to
be expressed in writing and supported by appropriate scientific
evidence. [p g4]
Upon such notification, the agreement requires the de-
partment responsible for final action to take the initiative to work
out a basis for agreement. In the event agreement is not reached
among the department representatives within 2 weeks of the
initial objection, the agreement provides for the matter to be re-
ferred directly to the Secretary of the department responsible for
final action with such information, views and recommendations
as the representatives of the three departments deem appropriate.
The agreement further provides that the Secretary charged with
final action will notify the other two departments in advance of
the proposed final determination of the issues.
Departmental representatives responsible for implementing the
agreement are required to jointly make a quarterly report con-
cerning their activities to the Secretaries of the three depart-
ments. The agreement also requires that a general conference be
held at least once each year—
to discuss research needs, research program and policy, and
the application of research findings in action programs,
including public information relating to pesticides.
Registration of pesticides over objections
At a subcommittee hearing on May 7, Dr. Harry W. Hays,
Director of the Pesticides Regulation Division, was asked how
many pesticide products were currently registered by PRD for
marketing although the Public Health Service or some other
Government agency had expressed doubt concerning their safety
or effectiveness. Dr. Hays gave the following response:2S
Well, we have some 45,000 products registered with the
Pesticides Regulation Division and of that I don't think
there is more than—I really don't know. I would say a half
dozen in which the Public Health Service has expressed
some concern.
Further inquiry by the subcommittee disclosed that neither the
Pesticides Regulation Division nor the Public Health Service ac-
tually knew how many such products are being marketed. USD A
3* Hearing record, p. :
-------
GUIDELINES AND REPORTS 1447
witnesses admitted at a later hearing that no separate records
were kept to identify products registered over PHS objections
and that it would be necessary to make an extensive review of
individual files to identify such products. HEW witnesses told the
subcommittee that they did not know how many products to
which they had objected were on the market because USD A did
not inform them of the action taken concerning their objections.
(The mere fact that a product to which PHS objected was regis-
tered did not necessarily mean that an objection had been ignored,
since some objections could have been resolved by requiring a
change in labeling prior to registration.) 26
While the total number of pesticide products being marketed
over PHS objections is not known, it is obviously many times
larger than the "half dozen" suggested by Dr. Hays' testimony
on May 7. USDA subsequently advised the subcommittee that
during fiscal year 1969 alone, "there were 185 registrations or
reregistrations that appear to have been issued over Public
Health Service's objections." 27
[p. 35]
During a 5-year period from July 1, 1964, through June 30,
1969, according to figures furnished by USDA, a total of 1,633
objections to proposed registrations or reregistrations were made
by PHS. The number of objections reported for each of the 5 fiscal
years included in this period ranged from a high of 545 in fiscal
1967 to a low of 185 in fiscal 1969.28
USDA cited the decrease in objections in fiscal 1969 from prior
years as evidence it had made use of many of PHS' objections.
HEW contended, on the other hand, that its review indicated
USDA was registering practically all products objected to and
that USDA figures showed more products registered over HEW
objections in some years than the number of objections actually
made.29
Noncompliance with provisions of agreement
Dr. George W. Irving, Administrator of the Agricultural
Research Service, told the subcommittee that he felt that ARS
had adequately considered objections made by the Public Health
Service to products proposed for reregistration. Dr. R. J. Ander-
son, the Associate Administrator, stated in testimony concerning
the interdepartmental agreement that the advice and recommen-
26 Hearing record, pp. 73-74, 126, 133.
2T Hearing record, p. 801.
28 Hearing record, p. 302.
29 Hearing record, pp. 301-302.
-------
1448 LEGAL COMPILATION—PESTICIDES
dations of HEW and the Department of Interior "are considered
and weighted carefully in connection with the decision to register
or refuse registration of a product." 30
Further investigation by the subcommittee indicated that PHS
officials took a much less optimistic view of interagency cooperation
under the agreement. Toward the end of 1964, Dr. Daniel I. Mullal-
ly of the PHS Office of Pesticides wrote a memorandum to Dr.
Howard Bond, Chief of the Office's Registration Staff, concerning
a November 20,1964, meeting with Justus Ward, then Director of
the USDA Pesticides Regulation Division. In concluding the
memorandum, Dr. Mullally stated that:
In summary, this meeting and other developments before
and since this time, have only served to confirm my opinion
that the Registration Division of the USDA has no intention
of complying with the spirit or even the letter of the terms of
the interdepartmental agreement.
Dr. Mullally's concern appears, in retrospect, to have been justi-
fied. Item 2(e) of the interagency agreement provides that:
In the event agreement is not reached among the depart-
ment representatives within 2 weeks of the initial objection,
the matter will then be referred directly to the secretary of
the department responsible for final action * * *.
However, the subcommittee investigation disclosed that not a
single one of the more than 1,600 objections made by HEW was
referred to the Secretary of Agriculture. Dr. Irving told the sub-
committee that ARS felt they had resolved the issues involved in
the objections by allowing the products to be placed on the market
and that there consequently was no need to refer the matters to
the Secretary.31
Failure of the Pesticides Regulation Division to comply with the
provisions of item 2 (e) were called to the attention of the Agricul-
tural
[p. 36]
Research Service in a November 1965 report by a task force
assigned to review registration and enforcement procedures of the
Division. The report cited the requirement that objections be
referred to the Secretary "in the event agreement is not reached
among the department representatives within 2 weeks of the initial
objection," and stated flatly that "this has not been done." The
30 Hearing record, pp. 11, 72-73.
81 Hearing record, pp. 66, 71.
-------
GUIDELINES AND REPORTS 1449
report was submitted to Dr. R. J. Anderson, ARS Associate Ad-
ministrator, on November 19,1965.32
Chairman of the 1965 task force was Dr. Harry W. Hays, then
Director of the Advisory Center on Toxicology for the National
Academy of Sciences-National Research Council, who was subse-
quently named Director of the Pesticides Regulation Division.
When asked whether he remembered the 1965 comment by the
task force on item 2 (e), Dr. Hays responded that:
I really don't recall, sir. I have not reviewed that report
for some time.33
The subcommittee subsequently located a September 29, 1965,
memorandum from E. P. Reagan, Acting Deputy Administrator,
ARS, to Carl Barnes, USDA Director of Personnel, giving details
of the task force study and the particular areas of inquiry to each
individual member. The memorandum stated that:
Dr. Hays personally looked into operations under the [inter-
departmental] agreement * * *.
Item 3 of the interdepartmental agreement provides for a gen-
eral conference of departmental representatives to be held at least
once each year. However, testimony at subcommittee hearings
disclosed that not one such meeting had been held during the more
than 5 years since adoption of the agreement.34
Evidence of continued lack of cooperation
The General Accounting Office reports concerning operations of
the Pesticides Regulation Division were issued in September 1968
and February 1969. At its May 7, 1969, hearing, the subcommittee
was informed that a meeting of representatives of USDA, HEW,
and Interior had been held on March 19, 1969. One of the pur-
poses of the meeting, the subcommittee was told, was to help
resolve differences of opinion among departmental representatives
and to improve cooperation in connection with the agreement.35
While the March 19 meeting may have been a step in the right
direction, it clearly did not bring about complete cooperation. The
subcommittee found that on March 21, 1969, 2 days after the
meeting, Dr. Thomas H. Harris, Director of the Division of Pesti-
cide Registration, Food and Drug Administration (which now has
responsibility for label review activities formerly assigned to the
Public Health Service) addressed a letter to the USDA Pesticides
82 Hearing record, pp. 248, 287.
33 Hearing record, p. 28.
8* Hearing record, pp. 71,128.
so Hearing record, pp. 5, 27.
-------
1450 LEGAL COMPILATION—PESTICIDES
Regulation Division requesting information relating to whether or
not certain pesticide products to which objections had been made
were currently registered. A file memorandum prepared by Dr.
Harris indicates that no answer to the letter had been received as
of April 2 and that Dr. Harris called PRD on that date "to ascer-
tain whether or not this information would be forthcoming."
According to the memorandum, Dr. Harris
[p.37]
was informed that Dr. Harry W. Hays, Director of the USDA
Pesticides Regulation Division, would call him. Dr. Hays, accord-
ing to the memorandum, asked why FDA wanted the information
and was told that it was needed in order to ascertain whether the
product involved had been registered over HEW safety objections.
Dr. Harris' memorandum gave the following account of the
remainder of his telephone conversation with Dr. Hays:36
Dr. Hays said that the information requested was, in his
opinion, not related in any way to the requirements in the
agreement and that the agreement did not require that PRD
furnish us with such information. I reminded Dr. Hays that
paragraph 1, information, page 2 of the agreement states
in part, "Upon request, the Departments of Agriculture and
Health, Education, and Welfare, respectively, will furnish
to the other departments full information about any pend-
ing action on registration or the setting of a tolerance." To
this he did not comment.
Dr. Hays told me that as a result of the two General
Accounting Office reports he was suspicious of everybody and
that he thought the GAO was out to get him. He claimed that
certain members of his staff had been misquoted in the GAO
reports and that from now on any information that came out
of PRD would be very carefully screened by him beforehand.
He said that if he gave us the information requested in our
letter he was of the opinion it would be used against him.
I asked Dr. Hays if all this meant that we could not expect
to receive this information. He replied, "I didn't say that."
I then asked when we could expect to receive the information.
He replied, "I have no idea." I asked if this meant that it
might be 6 months before we could expect to obtain the infor-
mation and he said, "I cannot tell you. I have no idea." At
this point I thanked him and told him that I had another
matter that I would like to discuss with him.
86 Hearing record, pp. 131-132.
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GUIDELINES AND REPORTS 1451
Misconception of burden of proof
The subcommittee investigation indicated that a significant
factor in the registration of such a large number of pesticide prod-
ucts over unresolved safety objections was a basic misunderstand-
ing by USDA officials of the legal requirement that pesticides must
be shown to be safe before being registered.
In the discussion of Hndane earlier in this report, it was noted
that USDA officials—although admitting that it was the responsi-
bility of would-be registrants to establish the safety of their
products—conducted themselves as though products should be
registered unless those opposed proved them to be hazardous. This
pattern of conduct was not limited to lindane products.
Dr. R. J. Anderson, Associate Administrator of the Agricul-
tural Research Service told the subcommittee that:3T
The current legislation, amended in 1959 and 1962, is based
on the concept of protecting the public and our total environ-
ment from possible hazards created by the use of economic
[p. 38]
poisons. Registration procedures require proof of the safety
and effectiveness of a material before it is marketed in inter-
state commerce.
Other statements by USDA officials, however, indicated that this
policy was not followed. Dr. George W. Irving, ARS Administra-
tor, told the subcommittee that:
* * * the action we take is to register in the absence of
evidence to indicate it shouldn't be.
Dr. Ned D. Bayle, USDA Director of Science and Education,
told the General Accounting Office in a November 27, 1968, letter
that lindane products had been registered over objection of the
Public Health Service because :
* * * ARS felt that the evidence was not sufficiently well
documented * * * to refuse registration.38
Prior to early 1964, there might have been some basis for a
belief that it was necessary to show a pesticide was hazardous to
justify refusing registration of a pesticide product which had not
been clearly demonstrated to be safe. Until then, the Federal Insec-
ticide, Fungicide, and Rodenticide Act required USDA to register
a product under protest, if the applicant insisted, even though
USDA did not believe it had been shown to be safe. The registrant
87 Bearing; record, p. 2.
88 Hearing record, pp. 65, 216.
-------
1452 LEGAL COMPILATION—PESTICIDES
could then sell the product to the public unless and until US DA
was able to develop legally acceptable proof to justify a court
decision to remove the product from the market. However, Public
Law 88-305, signed by the President on May 12, 1964, amended
FIFRA to eliminate protest registration and make it clear that
the burden of establishing the safety of a pesticide must be met by
the applicant before it could be registered.
Although officials of the Pesticides Regulation Division complete-
ly ignored some provisions of the interdepartmental agreement—
such as the one requiring unresolved objections to be referred to
the Secretary—there was at least one conspicuous exception. Sec-
tion 2(d) of the agreement provides that if a department con-
cludes that a registration proposal should be rejected, this view
shall be expressed in writing and "supported by appropriate
scientific evidence." When the agreement was adopted, in March
and April 1964, pesticides could still be marketed under protest
registration; under then existing law, evidence of hazard might be
useful or even essential in keeping a particular pesticide off the
market. Since May 1964, however, the law has clearly required
that the safety of pesticides be established before they are regis-
tered; in the absence of adequate evidence of safety, a product
cannot legally be registered even if there is no proof that it is
hazardous. Interagency agreements cannot, of course, contain
requirements which contravene mandatory provisions of the stat-
utes. Nevertheless, USDA has consistently taken the position that
it was free to ignore safety questions raised by HEW unless it
was furnished with scientific proof that the pesticide involved
was hazardous.
POOD ADULTERATION
Statutory prohibition of food adulteration
The Federal Food, Drug, and Cosmetic Act prohibits adultera-
tion of food in interstate commerce.39 Under the act, a food is
deemed to be [p 39]
adulterated if it bears or contains any poisonous or deleterious
substance which may render it injurious to health ;• if the sub-
stance is not an added substance, however, the food is not
considered adulterated if the quantity of such substance in the
food does not ordinarily render it injurious to health.40 If, on the
other hand, the food contains an added poisonous or deleterious
substance (other than one which is a pesticide chemical in or on a
8» 21 U.S.C. 831.
*°21U.S.C. 342(a) (1).
-------
GUIDELINES AND REPORTS 1453
raw agricultural commodity, a food additive or a color additive),
it is considered to be adulterated under the act regardless of
whether or not it would be injurious to health except where such
substance is required in the production of the food or cannot be
avoided by good manufacturing practice.41
Although not covered by the general prohibition against any
added poisonous or deleterious substances, a pesticide chemical in
or on a raw agricultural commodity is considered under the act to
adulterate such commodity, if the chemical is not generally recog-
nized by experts as safe, unless a tolerance for the chemical has
been issued and the amount is within the tolerance or unless the
chemical has been exempted from the requirement of a tolerance
with respect to use on the commodity. Under the act, the Secre-
tary of Agriculture is responsible for determining whether a pesti-
cide chemical is useful to agriculture when used as proposed, and
the Secretary of Health, Education, and Welfare is then responsi-
ble for determining a safe tolerance—which may even be zero.42
A food additive is defined in the act as any substance not gener-
ally recognized by experts as safe:
The intended use of which results or may reasonably be
expected to result, directly or indirectly, in its becoming a
component or otherwise affecting the characteristics of any
food.43
A poisonous or deleterious substance which is a food additive
is considered under the act to adulterate food unless a regulation
has been issued by HEW prescribing the conditions under which
such additive may be safely used and its use conforms with such
regulation or unless it has been exempted from the requirements
of the act for investigational use by qualified experts. Where a
pesticide chemical has been used in or on a raw agricultural com-
modity in conformity with an exemption or tolerance, the residue
of such chemical remaining in or on processed food is not con-
sidered to adulterate the food if the residue has been removed to
the extent possible in good manufacturing practice and the con-
centration of the pesticide residue in the processed food is not
greater than the tolerance prescribed for the raw commodity.44
Approval of pesticide uses likely to contaminate food
The Food and Drug Administration has primary responsibility
for enforcing provisions of Federal law prohibiting adulteration
41 21 U.S.C. 342(a) (2) (A); 21 U.S.C. 346(a).
*221 U.S.C. 342(a) (2) (B); 21 U.S.C. 346 (a).
*321 U.S.C. 321 (s).
«21 U.S.C. 342(a) (2) (C); 21 U.S.C. 348.
-------
1454 LEGAL COMPILATION—PESTICIDES
of food. However, the Department of Agriculture plays—or
should play—a significant role in preventing adulteration of food
by pesticides. In accordance with a recommendation of the Presi-
dent's Science Advisory Committee on Use of Pesticides, HEW
and USDA jointly contracted with the National Academy of
Sciences-National Research Council to r .„,
[p. 40]
make a study of problems involved in regulating pesticide resi-
dues on food. The study was made by a pesticides residue commit-
tee under the chairmanship of James H. Jenson, president of
Oregon State University; the Committee's secretary was Dr.
Harry W. Hays. In a June 1965 report, the Committee gave the
following description of USDA's position with respect to registra-
tion of pesticides which might leave residues on food:
The Federal Insecticide, Fungicide, and Rodenticide Act
carries no specific provisions relating to the contamination
of food. However, in administering the act, the U.S. Depart-
ment of Agriculture has taken the position that directions
for use of a pesticide are not adequate to protect the public
if any use of it might leave a residual amount of the pesti-
cide on food or feed crops that would make them subject to
action by the Food and Drug Administration.
However, the subcommittee investigation disclosed that USDA's
Pesticides Regulation Division had registered pesticides for uses
which were obviously likely to result in illegal residues on food.
An example, which has been discussed previously in this report,
was the registration of lindane for use in continuous vaporizers
in restaurants. Because such products kill insects by filling a room
with pesticide, it is obvious that a residue of the pesticide could
be expected in any exposed food in the room—in fact, it would be
most surprising if there were no residue under such conditions.
USDA not only should have anticipated that lindane vaporizers
would leave residues on food in restaurants, but was provided
with an FDA study in 1953 which concluded that such residues
would result. Nevertheless, USDA continued to register and re-
register lindane for use in continuous vaporizers in restaurants
for more than 15 years. When USDA finally made its own tests,
after release of a GAO report criticizing continued registration
of lindane, it took only 5 days to establish that residues would
result.45
Another example involved the registration by PRD of the Shell
Chemical Co.'s "No-Pest Strip" and substantially identical prod-
is Hearing record, pp. 30-31, 87.
-------
GUIDELINES AND REPORTS 1455
ucts distributed by other companies. The active ingredient of the
"No-Pest Strip" is vapona, Shell's trade name for the chemical
2,2-dichlorovinyl dimethyl phosphate, which is also known as
DDVP or dichlorvos. In the "No-Pest Strip," vapona is incor-
porated into a resin which is molded into plastic strips and sealed
into an envelope of metal foil. After removal of the wrapper,
vapona is released slowly from the strip; according to the label,
the strip retains its insecticide properties for up to 3 months.
Directions for use call for one strip for each 1,000 cubic feet of
space.
Although the "No-Pest Strip" did not utilize an electrical va-
porizer, as did lindane products, the purpose of the strip was simi-
lar—to fill a room with a sufficient concentration of pesticide to
kill insects. Despite the obvious likelihood that residues would be
left on food, the Pesticides Regulation Division registered Shell's
vapona strip and similar products beginning in 1963 for use in
restaurants and other places where food is customarily left un-
covered. The registration was continued even though tests made
by Shell disclosed that vapona strips r ...,
did leave residues of DDVP on exposed food and USDA officials
responsible for meat inspection would not allow use of the strips
in meat processing establishments.46
The subcommittee investigation disclosed that USDA had not
submitted proposed registrations and reregistrations of either
lindane vaporizers or vapona strips to FDA for a determination
as to whether or not any proposed use would result in illegal pes-
ticide residues on food. Moreover, the investigation indicated
that it was questionable whether FDA, if requested to do so,
would have authority under the Food and Drug Act to issue a
tolerance or a regulation allowing pesticide residues on food in
restaurants. While tolerances for pesticide residues on raw agri-
cultural commodities may be granted, many of the food items
normally served in restaurants would not be considered "raw
agricultural commodities." (The term "raw agricultural commod-
ity" is defined in the Food and Drug Act as "any food in its raw
or natural state.") The law authorizes FDA, under certain con-
ditions, to issue regulations permitting the use of pesticides as
food additives. However, FDA advised the subcommittee that it
is not clear that this would be permissible in the case of vapona.47
The subcommittee found that FDA had refused to approve a
tolerance for residues resulting from a device which was to re-
** Hearing record, p. 99.
*7 Hearing record, pp. 80, 87, 90, 91.
-------
1456 LEGAL COMPILATION—PESTICIDES
lease a mixture of pyrethrins and piperonyl butoxide in food
processing areas on an intermittent basis. In an October 10, 1963,
letter to the attorney for the applicant for the tolerance, J. K.
Kirk, Assistant Commissioner, FDA, made the following
comments :
* * * it is our view that the terms of the Food Additives
Amendment are such as to preclude the establishment of any
tolerance for a food additive in or on a food at a level higher
than reasonably required to accomplish the effect intended.
In this case we have a petition which is not limited to a spe-
cific food product; neither is there, in our opinion, a demon-
stration that the tolerance sought by your client is the result
of the use of the pesticide in an amount reasonably needed to
rid the establishment of flies.
On the contrary, we have before us a proposal for applying
this pesticide in all sorts of food producing and handling
establishments through a metering device which will add the
pesticide at frequent intervals, whether or not there is a
demonstrated need for that amount of the pesticide at any
particular time.
It is our view that the tolerance sought by your client for
the residual pesticide resulting from the use of his device
is not contemplated by the terms of the statute * * *
Whether or not it could legally have done so, FDA unquestion-
ably has not issued a tolerance for residues of lindane or vapona
on food in restaurants. And, since there are no tolerances, such
residues clearly constitute illegal adulteration of food.48
FDA-PRD action relating to residues from vapona strips
Earlier in this report, it was noted that the Department of
Agriculture has initiated action to cancel registrations permitting
saleof _ [p. 42]
lindane pellets for use in continuous vaporizers. After the
subcommittee hearings, USDA also initiated action to require
labeling of vapona strips to carry more specific warnings against
food contamination.
During his testimony, Dr. George W. Irving, Administrator,
ARS, assured the subcommittee that if FDA took the position
that a particular pesticide use would result in food adulteration,
ARS would accede to this position and require such labeling
changes as were necessary to prevent such adulteration. FDA
« Hearing record, pp. 88, 138.
-------
GUIDELINES AND REPORTS 1457
witnesses advised the subcommittee at its June 24 hearing that
a review of the registration of vapona strips would be made.49
On August 6, 1969, FDA informed the USDA Pesticides Regu-
lation Division that FDA's review of residue data submitted by
the Shell Chemical Co. for vapona strips—particularly a 1964
study conducted in New Jersey—had led it to conclude:
* * * That the use of these strips in accordance with label directions will
result in contamination of exposed foods.
FDA further advised PRO that:
As you know, the registered label for this product bears
the statement "Do not contaminate food, water, and food-
stuffs" but no information is present on the label specifying
just how this contamination can be avoided. We conclude that
the contamination feature calls for clearcut additional in-
structions warning against using the strips in areas where
food is prepared or served; for example, "Do not use in
kitchens or dining areas" and also include a specific restau-
rant prohibition.
We are bringing this matter to your attention with the
belief that you will want to require the registrants to amend
these labels in such a manner as to avoid contamination of
feed, water, and foodstuffs.
The Pesticides Regulation Division has advised the subcommit-
tee that all firms which have registrations for vapona strips have
been informed that labels must be revised to bear the warning
"Do not use in kitchens, restaurants, or areas where food is pre-
pared or served."
LABELING OF PESTICIDES
PRD approval of confusing and contradictory labeling
The Federal Insecticide, Fungicide, and Rodenticide Act pro-
hibits the interstate shipment of any economic poison which is
misbranded. The act provides that the term "misbranded" shall
apply to any economic poison if the labeling accompanying it
does not contain directions for use which, if complied with, are
adequate for the protection of the public. It also designates an
economic poison as "misbranded" if any information required
by or under the authority of the act to appear on the labeling is
not placed thereon with such conspicuousness and in such terms
as to render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use. The
« Hearing record, pp. 97. 126-127.
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1458 LEGAL COMPILATION—PESTICIDES
act further provides that no economic poison shall be registered
until it has been determined that the poison's labeling complies
with the applicable provisions of the act.50 r . „,
During the earlier stages of the subcommittee's investigation,
its study raised questions concerning the adequacy of labeling
which had been approved for several products. For example,
products containing thallium sulfate, a highly toxic ant and rat
poison, bore warnings that the poison should be kept away from
children and pets; however, the directions for use advised that it
be placed on floors and in other places accessibile to rats and ants
—and obviously accessible to children. Products containing lin-
dane and vapona bore warnings against contamination of food,
but their labels indicated they were approved for use in restau-
rants under conditions practically certain to result in contamina-
tion of any exposed food.51
In view of these questions, Dr. Harry W. Hays, Director of the
Pesticides Regulation Division, was asked at the subcommittee's
June 24 hearing whether he was confident that products presently
being approved for registration were being screened carefully
enough so that such obviously contradictory labeling could no
longer get by. Dr. Hays responded as follows: 52
I think we are doing the best job possible, Mr. Chairman,
in screening not only the labels but in reviewing and review-
ing again, all the data submitted with that particular appli-
cation, to make certain that the precautionary labeling is
consistent with the data and that the directions for use are
adequate.
Despite Dr. Hays' confidence, the subcommittee found that
labeling for a concentrated fly and roach spray manufactured by
the Hysan Products Company of Chicago had been approved
(USDA Reg. No. 334-294) after the subcommittee's first hearing
although it bore obviously contradictory warnings and directions
for use. The warning notice on the label cautions the user to:53
Use in well ventilated rooms or areas only. Always spray
away from you. Do not stay in room that has been heavily
treated. Avoid inhalation.
However, the directions for use instructed the user to :
Close all doors, windows, and transoms. Spray with a fine
60 Hearing record, pp. 223-224, 227, 229.
51 Hearing record, pp. 19-20, 23, 61, 96-97.
52 Hearing record, p. 62.
63 Hearing record, p. 63.
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GUIDELINES AND REPORTS 1459
mist sprayed freely upwards in all directions so the room is
filled with the vapor. If the insects have not dropped to the
floor in 3 minutes repeat spraying, as quantity sprayed was
insufficient. After 10 minutes doors and windows may be
opened.
Misleading effectiveness claim
In addition to poisons bearing inadequate safety warnings and
directions, the act designates an economic poison as "misbranded"
if its labeling bears any statement relative to the product which
is false or misleading in any particular.54
Since disinfectants are classified by law as economic poisons,
such products must be registered by USDA before being sold in
interstate commerce. One registered product claiming disinfec-
tant properties is the detergent Cold Power which has been
widely advertised as "germproofing" clothes even when used in
cold water. Labeling
[p. 44]
approved for this product by the Pesticides Regulation Division
makes the claim that it "germproofs."
Under questioning at subcommittee hearings, Dr. Hays testified
that Cold Power would not kill germs and would at most only
inhibit the growth of bacteria. Dr. Hays further acknowledged
that the ordinary individual would regard a substance which
"germproofs" as one which is proof against germs, rather than
one which simply inhibits their growth.55
On July 7, 1969, USDA announced that "germproofing" claims
would no longer be accepted on labels unless data was furnished
to show that the product involved "will impart self-disinfecting
properties."
University of Illinois study of pesticide labeling
The subcommittee was informed during its investigation that
the Pesticides Regulation Division had arranged for an in-depth
study of pesticide labeling to be made by the University of Illinois.
The study is being performed under a contract entered into on
June 19, 1968, which provides for a study to be completed by May
31, 1970, at a cost of $52,000.
As might be expected, personnel working on the University of
Illinois project had not—as of mid-1969—reached any formal
conclusions as to the adequacy of pesticide labeling nor made rec-
ommendations concerning methods of improving it. However, in
5* Hearing; record, p. 223.
55 Hearing record, pp. 38—89.
-------
1460 LEGAL COMPILATION—PESTICIDES
a report covering activities from January 1 to March 31, 1969,
they reported that a nearly completed review of literature relat-
ing to pesticide labeling had given them "* * * a broad view of
the dimensions of the problem of studying the communication
effectiveness of pesticide labels."
The problem, as perceived by the project investigators, is rather
basic. According to the report, their review of literature indicated
first "that most of the pesticide users do not read pesticide labels"
and second that "* * * in general, users find it difficult to under-
stand pesticide labels when they read them."
PESTICIDE POISONINGS
Reliance on accident reports to detect dangerous products
In his testimony, Dr. Harry Hays indicated that the Pesticides
Regulation Division placed considerable reliance on accident re-
ports as a means of detecting dangerous pesticides, particularly
those products with potential hazards which might not have been
fully apparent at the time of registration. Dr. Hays told the sub-
committee that: 56
* * * For any accident that is associated with any pesti-
cide we have a complete review by a group that I have
assigned to this task. It is their responsibility to review every
accident, regardless of what it is, to determine what the
cause may have been and what we could have done to prevent
it perhaps through labeling, whether it was an accidental in-
gestion, whether it was a suicide attempt, no matter what
it was.
USDA was asked to submit for the record a description of its
arrangements for receiving reports of pesticide poisoning and its
evaluation of how well these arrangements were believed to be
working. The
[p. 45]
material submitted indicated that the accident reporting network
had been established in 1966 and consisted of personnel of three
units of the Agricultural Research Service—the Plant Pest Con-
trol Division, the Animal Health Division, and the Pesticides Regu-
lation Division—and the Pesticide Coordinators of the Federal
Extension Service. Although the ARS Plant Pest Control Division
is presently designated as coordinating office, the subcommittee
was advised that it is proposed that this responsibilty be trans-
ferred to the Pesticide Regulation Division. The subcommittee
06 Hearing record, p. 20.
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GUIDELINES AND REPORTS 1461
was informed that "the reporting system appears to be working
very well * * *.""
Seriously inadequate information on pesticide poisonings
Further inquiry by the subcommittee disclosed that USDA
received reports of approximately 150 to 175 pesticide poisoning
incidents during 1968. However, the subcommittee was told that
only 52 of these incidents involved humans; the other incidents
involved domestic animals, crops, fish, and wildlife, water pollu-
tion and other categories. A total of 163 people were involved in
the 52 incidents in which poisonings of humans were reported,
according to Dr. Hays.58 When asked his opinion as to how the
number of reports received by USDA compared with the total
number of pesticide poisonings occurring each year, Dr. Hays
responded:59
I don't believe there is any way in which we can really
ascertain that figure. I have seen figures that are rather, in
my opinion, astronomical. And I certainly don't believe that
one report of some 20,000 accidents is anywhere near correct.
We are sure we don't receive all reports of all accidents, but I
believe we get a fair share of those involving economic
poisonings.
Dr. Hay's opinion that the 163 reports of humans being poi-
soned by pesticides constituted a "fair share" of the total con-
trasted sharply with information obtained by the subcommittee
from the National Clearinghouse for Poison Control Centers, a
unit of the Food and Drug Administration. The Poison Control
Centers consist of a network of voluntary units throughout the
country, usually associated with hospitals, whose primary pur-
pose is to serve as a source of immediate information concerning
the manner in which poisoning by various substances should be
treated. As a byproduct of their primary purpose, most of the
centers furnish reports to the central clearinghouse in Washing-
ton concerning the causes of poisoning cases which come to their
attention. Officials of the national clearinghouse informed the
subcommittee that they receive approximately 5,000 reports of
pesticide poisonings annually, about 4,000 of which involve chil-
dren under 5 years of age. They also advised that, in their opin-
ion, they receive reports on only about one out of every eight or
10 pesticide poisonings.
W Hearing record, p. 38.
58 Hearing record, pp. 55-67.
w Hearing record, p. 55.
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1462 LEGAL COMPILATION—PESTICIDES
Although Dr. Hays told the subcommittee that the Pesticides
Regulation Division had been routinely checking with the national
clearinghouse to review records on pesticides accidents, he admit-
ted that he was unaware that the clearinghouse received approxi-
mately 5,000 pesticide poisonings reports annually or that it pre-
pared computer runs
[p. 46]
listing the number of reports received by type of poison involved.60
Dr. George W. Irving, ARS Administrator, told the subcommit-
tee that is was his impression that the number of deaths from pes-
ticides is "very, very small." Neither Dr. Irving nor Dr. Hays
was able to provide an estimate as to the total number of deaths
resulting from pesticides. However, PRD personnel told the sub-
committee that 18 deaths resulted from the 163 human poisonings
reported to USDA in 1968.61
Dr. R. J. Anderson, Associate Administrator, ARS, told the
subcommittee that there has been no central reporting agency
within the Federal Government but that a task force of the Fed-
eral Committee on Pest Control has now been assigned responsi-
bility for determining what needs to be done to develop a compre-
hensive and coordinated system for reporting pesticide accidents
and injuries.62 (The Federal Committee on Pest Control is an
interdepartmental committee which reviews use of pesticides by
agencies of the Federal Government.)
CANCELLATION OF REGISTRATIONS
Legal authority for cancellation of registrations
Before elimination of "protest registration" in 1964, USDA's
statutory authority to cancel pesticide registrations was extremely
limited. The law authorized cancellation of a registration "in
order to protect the public," but required issuance of a registra-
tion under protest to replace it.
In 1964, the Federal Insecticide, Fungicide, and Rodenticide
Act was amended to provide that a registration may be canceled
whenever it does not appear that the registered product or its
labeling complies with the provisions of the act. When USDA
determines that a registration should be canceled, it is required
to notify the registrant of this action and the reasons for it. If
the reason for cancellation is one which can be eliminated by
corrective action (such as, for example, a change in labeling), the
60 Hearing record, p. 56.
61 Hearing record, pp. 58-59.
02 Hearing record, p. 60.
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GUIDELINES AND REPORTS 1463
registrant has 30 days after notice in which to take such action;
if adequate corrective action is taken within the time limit, there
is, of course, no longer any basis for cancellation. If the reason for
the cancellation action is not subject to corrective action or if the
registrant does not wish to take the requested action, the regis-
trant has two alternatives under the law. The registrant may file
a petition requesting that the matter be referred to an advisory
committee selected by the National Academy of Sciences or he
may request a public hearing; if neither of these actions is taken
within 30 days after notice of cancellation, the registration is
canceled.63
If referral to an advisory committee is requested, USDA is
required "forthwith" to submit all relevant data to the committee.
As soon as practicable after such submission, but not later than
60 days, unless the time is extended for an additional 60 days by
USDA, the committee is to submit a report and recommendation
to USDA as to registration of the product. Costs of the advisory
committee may be assessed against the registrant, unless the
committee recommends in his favor or the matter was referred
to the committee by USDA. After due consideration of the views
of the committee and all other data before him,
[p. 47]
and within 90 days after receipt of the report, the Secretary of
Agriculture must make a determination and issue an order with
respect to whether or not the registration shall be canceled. If the
registrant is dissatisfied with the order, he has 60 days in which
to ask for a public hearing.
If a public hearing is held, the Secretary must issue an order
with respect to cancellation or modification of the registration
within 90 days after completion of the hearing. The order must
be based only on substantial evidence of record in the hearing,
including the report and recommendations of the advisory com-
mittee if the matter was so referred.64 Such orders are subject
to judicial review.65 In the event of judicial review, the findings
of the Secretary as to questions of fact are to be sustained if they
are based on substantial evidence in the record.
Five-year failure to adopt rules of procedure
Although the 1964 amendments to FIFRA provided basic legal
authority for cancellation of pesticide registrations, this author-
ity could not be utilized in contested cases until rules of practice
637 U.S.C. 135b(c); (hearing record, pp. 229-232).
e* Ibid.
857 U.C.S. 135b(c) and (d); hearing record, pp. 232-233.
-------
1464 LEGAL COMPILATION—PESTICIDES
for hearings had been promulgated. Such rules did not become
effective until August 29, 1969, more than 5 years after the
amendments were adopted.
During the 5-year period between enactment of cancellation
authority and adoption of procedures to implement this authority,
a number of requests for public hearings or referral of a matter to
an advisory committee were received. The subcommittee investi-
gation indicated that when such requests were received, efforts
to pursue the cancellation action were abandoned and the product
involved was simply left on the market.
One instance in which this occurred involved Sibur Mothproof
Concentrate, registration No. 1110-1, an arsenic trioxide moth-
proofing agent for clothes, furs, bedding, rugs, and furniture
which was initially registered in 1948. On June 2, 1967, the Pub-
lic Health Service questioned the continued registration of this
product on the ground that serious questions had been raised as
to the hazard associated with wearing garments treated with
products containing arsenic compounds. On August 30, 1967, the
Pesticides Regulation Division notified the registrant that the
registration for the product would be canceled within 30 days
unless data could be furnished to show that its use would not
result in a hazard to persons wearing articles treated with it.
In response to a September 19, 1967, inquiry from an attorney
for the registrant asking for clarification, PRD replied on Sep-
tember 25, 1967, that the August 30 letter constituted a 30-day
notice of cancellation, but that the 30-day deadline would be
extended in the event of a request for a hearing or referral to an
advisory committee. On September 28, 1967, the attorney wrote
back to request a public hearing.
On January 24, 1968, attorneys for the registrant again wrote
the Pesticides Regulation Division asking for confirmation of their
belief that, since they had requested a public hearing which had
not been held, Sibur Mothproof Concentrate could still be sold
legally. On February 15, 1968, PRD replied that: .- 4g,
Registration for this product has not been canceled and it
can still be legally shipped in interstate commerce at this time.
As of August 30, 1969, 2 years after the original 30-day notice
of cancellation had been sent to Sibur, no hearing had been held
and the product was still registered.
From 1967 until August 29, 1969, when rules of practice were
finally promulgated, the subcommittee found that at least 18 other
companies had requested public hearings or referrals to advisory
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GUIDELINES AND REPORTS 1465
committees involving a total of at least 46 products. In each of
these cases, so far as the subcommittee is aware, the request had
the effect of halting any further cancellation proceedings and the
product involved is still on the market.
Inaction by USD A Office of General Counsel
As evidenced by the 5-year delay in promulgation of rules of
practice for cancellation actions, the USDA Office of General
Counsel took no action on its own initiative to prepare appropriate
administrative procedures to implement the 1964 legislative
changes. Moreover, OGC apparently ignored a specific request
from the Agricultural Research Service that such procedures be
established. On April 2, 1968, F. R. Mangham, Acting Adminis-
trator, ARS, wrote E. H. Shulman, USDA General Counsel, to
advise that a request for a public hearing on a registration had
been received by the Pesticides Regulation Division. Mr. Mang-
ham stated that:
Since the Division has not gone through this procedure
since the act was amended in 1964, we would like to know
what procedural steps are necessary in granting the hearing
as provided under the law.
Although the Mangham memorandum to Shulman asked for
"an early opinion on this matter," ARS officials advised the sub-
committee that they were unable to locate any reply.
PRD officials also wrote letters in October 1968 to a number of
registrants who had requested public hearings or referrals to an
advisory committee stating that the Office of General Counsel had
been asked to set forth the procedural steps to be followed in
granting their requests.
Failure to pursue contested cancellation actions
Since May 1964 USDA has had specific statutory authority to
cancel pesticide registrations when the facts warrant such action.
Under the law, a registrant who requests it must be granted a
public hearing before registration of his product can be can-
celed. As of the end of September 1962, no such public hearing
had ever been held. Administrative procedures for such hearings
did not even exist until August 29, 1969.
A large number of registration cancellations have taken place
since 1964; however, not one of these cancellations has been the
result of a contested cancellation action. Many cancellations have
been noncontroversial label changes, fully agreed to or even ini-
tiated by the registrant. In other instances, newly available infor-
-------
1466 LEGAL COMPILATION—PESTICIDES
mation disclosed a likelihood that previously approved uses might
leave illegal residues on food crops and subject such crops to
seizure by the Food and Drug Administration; cancellations of
these uses were not contested by the registrants.
[p. 49]
The Pesticides Regulation Division did send a number of 30-day
notices of cancellation to registrants; if the registrant did not
request a hearing or referral to an advisory committee within 30
days, the registration was canceled by default. If, however, the
registrant called what amounted to a bluff by PRD by requesting
a hearing or referral to an advisory committee, the cancellation
proceeding was suspended indefinitely and the product remained
on the market.
Two-year delay in cancellation action on arsenic compounds
Even if prompt action were to be taken by USDA, statutory
requirements for cancellation of registrations would make a con-
tested proceeding potentially very time-consuming. First, a 30-
day notice of cancellation must be given. If referral to an advisory
committee is requested, the committee study may take a maximum
of up to 120 days after referral. The Secretary of Agriculture has
90 days after the committee reports to make a determination and
issue an order; if the registrant is dissatisfied with the order, he
has 60 days to request a public hearing. After completion of a
hearing and issuance of a decision, the registrant could still seek
judicial review of an adverse determination. Until the litigation
was finally decided, the registration would not be canceled and the
product could remain on the market.66 (A statutory provision
permitting suspension of registration under certain circum-
stances will be discussed later in this report.)
Despite the fact that a contested cancellation proceeding could
take many months at best, the subcommittee found that in the
case of certain arsenic compounds, USDA resorted to an unneces-
sary preliminary procedure—which took nearly 2 years—before
even starting cancellation proceedings.
On August 1, 1967, the Pesticides Regulation Division notified
manufacturers, formulators, distributors, and registrants of pes-
ticides containing sodium arsenite and arsenic trioxide that prod-
ucts containing these substances had been involved in "numerous
accidents involving children and domestic animals." (Such prod-
ucts are used primarily as weedkillers, soil sterilizers and, in a
few instances, for termite control.) PRD further advised recip-
es Hearing record, pp. 91-95.
-------
GUIDELINES AND REPORTS 1467
ients of the notice that products containing more than 2 percent
sodium arsenite or 1.5 percent arsenic trioxide would no longer be
acceptable for use in or around the home. Although the notice
states that labeling of products exceeding the specified percent-
ages must bear a warning against home use and that the label
changes "should be initiated as soon as possible," it was not so
worded as to constitute the 30-day notice of cancellation required
by statute.
On November 25, 1967, nearly 4 months later, a notice was
published in the FEDERAL REGISTER stating, in effect, that the
Pesticides Regulation Division was considering issuance of a
formal interpretation taking the position already announced in
the August 1 notice. The November 25 announcement also stated
that interested persons would have 30 days after the date of pub-
lication to submit views or arguments concerning the proposed
interpretation. PRD informed the subcommittee that the Novem-
ber 25 announcement was made because of resistance to the August
1 position expressed by affected registrants.
On July 25, 1968, 8 months later, a further notice was pub-
lished in the FEDERAL REGISTER stating that "after thorough con-
sideration of all
[p. 50]
relevant matters" interpretation 25 was being issued. Interpreta-
tion 25, which was to become effective 90 days after publication,
restated the same position taken in the original August 1, 1967,
notice. On October 15, 1968, a few days before interpretation 25
was scheduled to become effective, still another notice was pub-
lished. It stated that, after the July 25 publication, "additional
information was submitted which requires further study," and
that the effective date of interpretation 25 was therefore being
"delayed until further notice."
During its hearings, the subcommittee requested that it be sup-
plied with any new data submitted between July and October 1968.
It was subsequently advised that the data submitted during this
period was essentially the same as that previously submitted.67
At the subcommittee's June 24, 1969, hearing, when asked the
status of the arsenicals matter, Dr. Harry Hays replied that:
* * * in order to resolve this matter we have referred it to
the National Academy of Sciences.
Under further questioning, Dr. Hays admitted that the matter
had not actually been referred to NAS, but that the Administrator
87 Hearing record, p. 110.
-------
1468 LEGAL COMPILATION—PESTICIDES
of ARS had been asked to so refer it. Further testimony made it
plain that 1) referral by ARS would mean that USD A would pay
the cost of the NAS study; if the study were made at the regis-
trant's request, the registrant could be held responsible for the
cost if the results did not support his position; 2) such a referral
would not set in motion the cancellation procedures required by
law, since this can be done only by a 30-day notice to the regis-
trant; and 3) the registrant might be legally entitled to demand a
second NAS study after notice of cancellation if the results of the
original study were adverse. Dr. George W. Irving, ARS Admin-
istrator, also acknowledged that he had personally concluded a
long time ago that the arsenical products were not safe for use
around the home.68
On July 17, 1969, USDA announced that the proposed limita-
tions on home use of products containing sodium arsenite or ar-
senic trioxide were being adopted and that manufacturers were
being sent notices that registration of products not in compliance
would be cancelled if appropriate label changes were not made
within 30 days. USDA did not refer the matter to the National
Academy of Sciences during the interim period between the sub-
committee's June 24 hearing and the July 17 announcement.
Further misunderstanding of burden of proof
Earlier in this report, it was pointed out that the Pesticides
Regulation Division has consistently conducted its operations as
though it was required to register a pesticide in the absence of
proof that it was hazardous, even though current law clearly
places the burden of proof on the would-be registrant to establish
the safety of his product. PRD's misconception of the burden of
proof has been even more pronounced with respect to cancella-
tion proceedings than in original registrations.
Since termination of "protest registration" in 1964, the basic
issue in determining whether or not a pesticide product is entitled
to registration—whether the particular proceeding relates to re-
fusal to issue an initial registration or proposed cancellation of
an existing one— r _.,,
[p. 51]
is whether or not the product involved is safe and effective and
thereby in compliance with the law. The burden of proving the
product is safe and effective is with the manufacturer in either
case.
It is apparent, however, that PRD personnel have been acting
on the assumption that once a product was registered, the burden
68 Hearing record, pp. 100-108.
-------
GUIDELINES AND REPORTS 1469
of proof shifted and it was up to PRD to prove the product was
not safe before the registration could be canceled. Furthermore,
PRD personnel took the position that it would be "discriminatory"
to refuse to accept new registrations for a product suspected of
being hazardous so long as existing registrations for the product
had not been canceled.69
POTENTIALLY HAZARDOUS PESTICIDES
No procedures for removing hazardous registered pesticides from
market
Earlier in this report, it was noted that Pesticides Regulation
Division enforcement branch procedures for removal from the
market of hazardous products which were not registered or did
not comply with the terms of registration were totally inade-
quate as of mid-1967 but had been improved substantially since
that time. The subcommittee investigation disclosed an equally
serious deficiency as of mid-1967 in registration branch proce-
dures for initiating action to remove from the market pesticides
which were discovered to be hazardous after being registered.
Moreover, as of mid-1969 the subcommittee found no evidence
of any real improvement in the latter situation.
Since 1964, the Federal Insecticide, Fungicide, and Rodenticide
Act has authorized the Secretary of Agriculture to suspend the
registration of an economic poison immediately when he finds
that such action "is necessary to prevent an imminent hazard to
the public." 70 However, at the time of subcommittee hearings 5
years later, the Pesticides Regulation Division had no criteria
for determining whether a particular product was hazardous
enough to warrant suspension of its registration so that it could
be removed from the market immediately nor did it have estab-
lished procedures for implementing such a determination. In fact,
the subcommittee investigation indicated that only one registra-
tion—for a product manufactured by the Aeroseal Corp., Camp
Hill, Pa.—had ever been suspended.71
Suspension of Aeroseal DDVP strip registration
The one suspension action taken involved a DDVP insecticide
strip similar in many respects to the Shell "No-Pest Strip" dis-
cussed earlier in this report.
According to testimony by Dr. Harry W. Hays, the registration
approved for Aeroseal covered a vapona strip to be manufactured
69 Hearing record, pp. 203-205.
'07 U.S.C. 136b(c), hearing record, p. 232.
71 Hearing record, pp. 86, 94.
-------
1470 LEGAL COMPILATION—PESTICIDES
by Shell and purchased from Shell by Aeroseal; the chemical com-
position of the registered product was to be identical to the Shell
"No-Pest Strip." Subsequently, Dr. Hays testified, Aeroseal began
manufacturing its own supplies of vapona rather than purchasing
the material from Shell. Dr. Hays told the subcommittee that the
active insecticide ingredient used by Aeroseal (DDVP) was the
same as that used by Shell, but the Aeroseal chemical was impreg-
nated into "blotter paper" rather than resin, as was the case with
the "No-Pest Strip." 72
Dr. Hays told the subcommittee he was "not completely familiar"
[p. 52]
with the circumstances leading to PRD action against Aeroseal.
Further questioning by the subcommittee disclosed that the
case began when representatives of Shell visited the Pesticides
Regulation Division to complain about the Aeroseal product. The
subcommittee investigation indicated that an official sample of
the product was obtained on March 20, 1969, and sent to a PRD
laboratory for anlysis. A notice of suspension was issued on March
24, only 4 days later; at the time it was issued no report had yet
been received from the laboratory. According to Harold Alford,
PRD Assistant Director for Registration, no reports of accidents
attributed to the Aeroseal product had been received prior to the
suspension notice.73 The March 24 suspension notice contained
the following language:
We have no information to show that the subject product
would be either effective or safe when used as directed. In
the absence of such information, we consider the product to
be potentially hazardous to persons exposed. Therefore,
registration for this product is immediately suspended as
provided in section 4(c) of the statute.
Dr. Hays told the subcommittee that his basic reason for con-
cern about the Aeroseal product was that the blotter type material
in which DDVP was impregnated might release a higher concen-
tration of DDVP than anticipated and that "the amount in the
atmosphere could reach a level that could produce some very
serious effects." 74
Failure to require relabeling of Shell DDVP strip
The Aeroseal DDVP strip and the Shell DDVP strip contained
identical active ingredients and similar directions for use; the
only significant difference between the two, apparently, was in
72 Hearing record, p. 81.
73 Hearing record, pp. 82-84.
74 Hearing record, pp. 86, 98.
-------
GUIDELINES AND REPORTS 1471
the material in which the active ingredient was impregnated.75
There was no such similarity, however, in the speed with which
the Pesticides Regulation Division reacted to complaints against
the two products.
Although Dr. Hays testified that he was "not aware of any
specific objections" by the Public Health Service to registration
of Shell's "No-Pest Strip," the subcommittee's investigation dis-
closed that PHS had objected to the registration of DDVP strips
from at least 1965 until early 1969. PHS' objection initially was
on the ground that DDVP strips deliberately subjected humans
to continued exposure to a pesticide. In late 1967, PHS officials
decided that the objection to Shell's vapona strip would be with-
drawn if an appropriate warning against exposure of infants
and aged and infirm persons were placed on the label. Subse-
quently, the Pesticides Regulation Division informed Shell on
several occasions that the warning must be added to the label;
however, no action was taken to enforce the PRD demand.
On January 8, 1969, Shell finally agreed to the added warning,
but the registration was not amended to reflect the change until
April 18, 1969. Under the amended registration, the warning
statement "Do not use in nurseries or rooms where infants, ill
or aged persons are confined," was required to appear on the
label of each "No-Pest Strip." 76 (Further discussion of circum-
stances involved in the label change appears later in this report.)
[p. 53]
After the change in registration, "No-Pest Strips" which did
not bear the required warning statement could not legally be
shipped or held for sale in interstate commerce. However, at the
time of the subcommittee's hearings in May and June 1969, no
action had been taken to remove vapona strips not containing the
warning from the market or to require that they be relabeled.
When asked about the situation, Dr. Hays commented that, "We
don't see any particular need for recalling these." Earlier the
same day, it might be noted, Dr. R. J. Anderson, Associate Admin-
istrator, ARS, had told the subcommittee that:
In safety precautions, we are particularly concerned about
effects upon young children and older people as the most
susceptible segments of our population.77
A few days after the subcommittee hearings, Shell was notified
75 Hearing record, pp. 81-82, 86.
76 Hearing record, pp. 76-77, 83.
77 Hearing record, pp. 4, 81, 78.
-------
1472 LEGAL COMPILATION—PESTICIDES
that all "No-Pest Strips" must be relabeled to bear the required
warning statement.
Inadequate procedures for following up cancellation actions
As indicated earlier in this report, the Enforcement Branch of
the Pesticides Regulation Division now appears to have reason-
ably adequate procedures for removing potentially hazardous pes-
ticides from the market through voluntary recalls or multiple
seizures when violative products are discovered by Enforcement
Branch inspectors. However, the subcommittee found that the
PRD had no procedures to insure that the Registration Branch
notified the Enforcement Branch in the event a pesticide registra-
tion was cancelled or amended for safety reasons.
Moreover, as the earlier discussion in this report of the han-
dling of thallium products and Shell's "No-Pest Strips" makes clear,
PRD deliberately left violative products on the market after can-
cellation or amendment of registrations.
Failure to warn public
The necessity for removing hazardous pesticide products from
marketing channels in order to protect the public is obvious. How-
ever, even if successfully accomplished, such action would not
protect anyone who had already purchased the hazardous product
and had it in his home.
The subcommittee investigation indicated that PRD issues rou-
tine press releases describing enforcement and cancellation actions
and that such notices are distributed to farm-oriented news media.
However, the investigation indicated that there were no proce-
dures for warning consumers of specific hazards which came to
PRD's attention concerning particular pesticide products. By con-
trast, it appeared that another unit of the Agricultural Research
Service—the Veterinary Biologies Division—took prompt and
vigorous action to alert livestockmen to possible hazards to cattle
from blackleg—malignant edema bacterin.78
In his June 24 testimony, Dr. Hays agreed that the idea of
issuing a specific warning notice to the public in every instance
where a product on the market may be dangerous "has virtue." T8
USDA subsequently issued warning notices relating to several
pesticide products.
[p. 54]
78Hearing record, pp. 10-11, 80.
79 Hearing record, p. 79.
-------
GUIDELINES AND REPORTS 1473
CONFLICT OF INTEREST QUESTIONS
CONFLICT OF INTEREST LAWS AND REGULATIONS
Restrictions on actions of Federal employees
Federal law prohibits certain actions by Government employ-
ees affecting a personal financial interest. The basic conflict of
interest statute applicable to Federal employees is 18 U.S.C. 208.
This section prohibits an officer or employee of the executive
branch of the U.S. Government, including a special Government
employee, from participating "personally and substantially as a
Government officer or employee, through decision, approval, dis-
approval, recommendation, the rendering of advice, investigation,
or otherwise in a judicial or other proceeding, application, request
for a ruling or other determination, contract, claim, controversy,
charge, accusation, arrest, or other particular matter" in which
he has a financial interest. The same prohibition applies, if, to his
knowledge, his wife or child or an organization in which he is
serving as an officer or employee or with which he is negotiating
or has any arrangement concerning prospective employment, has
a financial interest.
The penalty for violation of 18 U.S.C. 208 is a fine of not more
than $10,000, or imprisonment for not more than 2 years, or both.
The restrictions imposed by section 208 may be waived if the offi-
cer or employee received a written determination in advance that
the financial interest is not so substantial as to be deemed likely
to affect the integrity of his services or if the financial interest
has been exempted from the requirements of the law by a general
rule or regulation as being too remote or too inconsequential to
affect the integrity of Government officers' or employees' services.
A "special government employee" is defined for the purposes
of section 208 as an officer or employee of the executive or legisla-
tive branch of the U.S. Government "who is retained, designated,
appointed, or employed to perform, with or without compensa-
tion * * * temporary duties either on a full-time or intermittent
basis," for not more than 130 days during any period of 365 con-
secutive days.80
USDA regulations relating to employee responsibilities and
conduct, in addition to prohibiting actual conflicts of interest, also
provide that an employee may not have a direct or indirect finan-
cial interest that appears to conflict substantially with his re-
sponsibilities and duties as a Federal employee.81
8018U.S.C. 202(a).
81 Department of Agriculture Personnel Manual, 735-24(a).
-------
1474 LEGAL COMPILATION—PESTICIDES
Limitations on activities of former officers and employees
In addition to proscribing acts of present employees affecting
a personal financial interest, Federal law also places limitations
on activities of former officers and employees.
18 U.S.C. 207 (a) makes it unlawful for anyone who has been
an officer or employee of the executive branch of the U.S. Govern-
ment, including a special government employee, to knowingly act
after his employment has ceased:
as agent or attorney for anyone other than the United States
in connection with any judicial or other proceeding, applica-
tion, request for a ruling or other determination, contract,
claim, controversy, charge, accusation, arrest, or other par-
[p.65]
ticular matter involving a specific party or parties in which
the United States is a party or has a direct and substantial
interest and in which he participated personally and substan-
tially as an officer or employee, through decision, approval,
disapproval, recommendation, the rendering of advice, inves-
tigation, or otherwise, while so employed * * *
The penalty for violation of section 207 (a) is the same as that
applicable to section 208. The definition of "special Government
employee" applicable to section 207 (a) is also the same as for
section 208.
Under certain circumstances, former officers or employees may
be exempted from the coverage of section 207 (a) ; in such cases
a written determination that it is in the national interest must be
made and published in the FEDERAL REGISTER.82
The statute of limitations applicable to prosecutions for viola-
tions of sections 207 and 208 is 5 years.83
SERVICE OF DR. T. ROY HANSBERRY ON USDA TASK FORCE
Appointment of Shell official to review registration procedures
On July 6, 1965, Secretary of Agriculture Freeman announced
the appointment of a seven-member task force to study procedures
used by the Pesticides Regulation Division " * * * in determining
the safety and effectiveness of pesticides offered for Federal regis-
tration." Dr. Harry W. Hays, then of the National Academy of
Sciences, was named chairman. The announcement named four
USDA officials as members of the task force along with an official
of the California Department of Agriculture and one man from
8218U.S.C. 207 (b).
83 18 U.S.C. 3282.
-------
GUIDELINES AND REPORTS 1475
private industry. The latter was Dr. T. Roy Hansberry, Assistant
Director, Agricultural Research Division, Shell Development Co.,
Modesto, Calif. The Shell Development Co. is an affiliate of the
Shell Chemical Co., a division of Shell Oil Co.
The appointment of Dr. Hansberry to the task force, according
to testimony by Dr. George W. Irving, ARS Administrator, was
suggested by Dr. Harry W. Hays. Dr. Hansberry had served with
Dr. Hays on a National Academy of Sciences committee studying
tolerances for pesticide residues. Dr. Irving told the subcommittee
that the principal reason for wanting Dr. Hansberry on the task
force was so that he could review the procedures, facilities and
personnel at laboratories operated by the Pesticides Regulation
Division.84
Records of the task force are incomplete, for reasons which will
be made clear below. However, a September 29, 1965, letter from
E. P. Reagan, Acting Deputy Administrator, ARS, to Carl Barnes,
USDA Director of Personnel, indicates that the actual duties per-
formed by Dr. Hansberry as a member of the task force related to
registration procedures and policies, rather than laboratory oper-
ations. The letter states that Dr. Hays, chairman of the task force,
had assigned subcommittees to make detailed studies in specific
areas. The letter identifies Dr. Hansberry as being assigned to a
three-member subcommittee on "Criteria." The assignment of this
group, according to the letter, was to make :
* * * a critical review of the operations of each of the units
having responsibility for various phases of registration in
order to evaluate the criteria used by each unit in establishing
registration in terms of safety and effectiveness.
Hansberry conflict-of-interest clearance
According to information supplied by the Pesticides Regulation
Division, Shell Chemical Co. registered a total of 256 pesticide
products with PRD from the beginning of the registration pro-
gram through June 1969. Of these, 162 products were registered
before the end of 1965. (The total number of products currently
registered by Shell is sustantially less than 256 since a number of
product registrations have either been canceled or allowed to
[p. 56]
In view of the large number of pesticide products it sells — none
of which can be sold in interstate commerce unless registration is
approved by USDA — the interest of Shell Chemical Co. in PRD
8* Hearing record, p. 117.
-------
1476 LEGAL COMPILATION—PESTICIDES
registration procedures is obvious. At the time the task force was
appointed in 1965, Shell had reason to be particularly concerned
about objections being raised to continued registration of its No-
Pest Strip. Further details concerning the nature and extent of
such objections will be discussed later in this report.
ARS advised the subcommittee that, under procedures in effect
in 1965, prospective consultants were required to submit financial
statements which were reviewed from a conflict-of-interest stand-
point by the ARS Personnel Division and then forwarded to the
USDA Office of Personnel for further review. If there was consid-
ered to be a question regarding a possible conflict of interest, the
financial statement was to be submitted by the USDA Office of
Personnel to the Office of General Counsel.
Despite the extensive dealings between Shell and the Pesticides
Registration Division, the clearance form approved by the Office
of Personnel bears the typed notation:
The Agricultural Research Service does not have, or know
of, any official business with the persons, firms, or institu-
tions with which Dr. Hansberry has other financial interests
as reported on the SF-68 [statement of employment and finan-
cial interests] which might constitute a conflict of interest.
Dr. George W. Irving, ARS Administrator, was asked to ascer-
tain who was responsible for the purported ARS clearance state-
ment; he subsequently advised the subcommittee that he had
been unable to determine who had made the statement. Max Reid,
USDA's Deputy Director of Personnel, testified that Dr. Hans-
berry's SF-68 could not be located and that there was no record
that his employment had been cleared with the Office of General
Counsel.85
Clearance of the Hansberry appointment contrasted sharply, in
some respects, with the manner in which appointment of another
man associated with Shell had been handled a few weeks earlier.
That matter involved reappointment of Dr. Mitchell R. Zavon to
serve without compensation as a consultant to the Pesticides Regu-
lation Division; Dr. Zavon also served, according to his SF-68, as
consultant to the Shell Chemical Co. and held stock in" a Shell
affiliate. On May 7,1965, Dr. Zavon's SF-68 was forwarded by the
ARS Personnel Divi- r _„,
IP- 57J
sion to the USDA Office of Personnel with a notation on it "No
conflict in ARS." The letter of transmittal contained a specific
request that the SF 68 be sent to the Office of General Counsel
85 Hearing record, pp. 116-118.
-------
GUIDELINES AND REPORTS 1477
for clearance. The Zavon SF 68 was transmitted to the Office of
General Counsel on May 11, 1965; on May 21 it was returned to
the Office of Personnel with a notation that, although there was
no apparent conflict of interest, in view of Zavon's connection with
Shell Chemical Co. he should be advised of the provisions of
Executive Order 11222. This order, promulgated on May 8, 1965,
relates to Standards of Ethical Conduct for Government Officers
and Employees and includes a specific description of types of
conduct prohibited by conflict-of-interest laws and regulations.
(Activities of Dr. Zavon involving Shell's vapona strip are described
later in this report.)
The apparent failure of the office of personnel to send the Hans-
berry appointment to OGC for clearance also contrasts with the
handling of the appointment of Dr. Harry W. Hays as chairman
of the task force; Dr. Hays' SF 68 was sent to OGC for clearance.
Dismissal of task force secretary
In addition to naming members of the Pesticides Regulation
Task Force, Secretary Freeman's July 6 announcement designated
Harold G. Alford of the Pesticides Regulation Division as Execu-
tive Secretary of the unit. The initial meeting of the task force
was held on July 8 and 9, 1965. In his capacity as Executive Secre-
tary, Mr. Alford prepared comprehensive minutes of the meeting.
The last page of the minutes, page 28, contains the following
paragraph:
Mr. Alford reminded the group that there are restrictions
in the law regarding the disclosure of information relative to
formulas and thought that this should be thoroughly under-
stood since Dr. Hansberry is an industry representative. Dr.
Hansberry stated that he thoroughly understood the restric-
tions of the law and felt that no complications would arise.
In response to questions, Mr. Alford testified at subcommittee
hearings that when he arrived at the second series of meetings of
the task force, he was informed by Dr. Hays that his services were
no longer required. Dr. Hays told the subcommittee that he had
decided not to have Mr. Alford present because he wanted to have
"free and open discussions" and thought it would be better not to
have Alford—an employee of the Pesticides Regulation Division—
present. Dr. George W. Irving, ARS Administrator, told the sub-
committee that Dr. Hays' action in relieving Mr. Alford of his
responsibilities was concurred in at the time by R. J. Anderson,
then Deputy Administrator.86
86 Hearing record, pp. 116-116.
-------
1478 LEGAL COMPILATION—PESTICIDES
Although Mr. Alford's appointment as Executive Secretary had
been announced by the Secretary of Agriculture, the subcommittee
investigation disclosed no evidence that his dismissal had been
approved by—or even made known to—the Secretary. Moreover,
although Dr. Hays told the subcommittee he made it clear at a
task force meeting that he expected every member to respect the
confidentiality of certain types of material, the subcommittee
found no evidence that employees who had custody of confidential
information were instructed that Dr. Hansberry was not to have
access to it.87 r CQ-.
[p. 58]
Mr. Alford's minutes of the task force's first 2-day meeting give
a clear picture of what took place; as might be expected, the min-
utes indicate that the initial meeting was primarily a briefing and
planning session. No minutes were prepared for the subsequent
meetings at which decisions were made. Although Dr. Hays testi-
fied that he kept some notes,88 he subsequently advised subcommit-
tee staff members that he had destroyed the notes after completion
of the task force report.
Reference to Shell Chemical Co. in minutes of task force meeting
Page 7 of the minutes of the July 8-9 meeting indicates that
G. M. Downard, then head of the registration section, explained
the registration process to the task force "Using as an example the
Shell Chemical Co. as applicant." The minutes do not make clear
whether an actual registration application was used or whether
Shell's name was used in a hypothetical one. However, an August
4, 1965, memorandum from R. J. Anderson, then ARS Deputy
Administrator, to Carl B. Barnes, USDA Director of Personnel,
describing the work of the task force, states that "The registration
process is being examined as actual applications are processed."
At the time, two Shell applications for additional vapona strip
registrations were pending.
CONDUCT OP JOHN S. LEARY, JR.
Approval of Shell vapona strip for registration by John S. Leary, Jr.
The initial application for registration of Shell's vapona strip
was submitted by the Washington office of the Shell Chemical Co.
on January 22, 1963. John S. Leary, Jr., was then Chief Staff Offi-
cer for Pharmacology of the Pesticides Regulation Division; as
head of the Pharmacology Section, his responsibilities included
87 Hearing record, pp. 114-117.
88 Hearing record, p. 116.
-------
GUIDELINES AND REPORTS 1479
supervising review of labels to determine whether products pro-
posed for registration would be safe when used as directed. The
subcommittee investigation indicated that Leary played a signifi-
cant part in events involving Shell's vapona strip during his
service with PRD.
PRD records indicate that D. Thomas von Sumpter, a pharma-
cologist in Leary's section, reviewed the Shell application on Feb-
ruary 15,1963, and objected to the proposed labeling. On February
22, 1963, PRD sent a letter to Shell's Washington office advising
that the label should be changed to bear the word "Poison" and a
skull and crossbones; this position apparently was taken because
a liquid vapona product previously registered had been classified
as a substance highly toxic to man which requires such warnings.
Notations in the registration file for Shell's vapona strip indicate
that Shell representatives visited the Pesticides Regulation Divi-
sion to discuss the application on March 6, 1963, and that the
objection to the proposed labeling for the vapona strip was with-
drawn by Mr. Leary on the same day. On March 7, 1963, registra-
tion No. 201-136 was issued for Shell's vapona strip.
1964-65 participation by Leary interest involving vapona
Records in the files of the Pesticides Regulation Division indicate
that Mr. Leary met with representative of Shell in early 1964 and
on April 14,1965, to discuss matters involving the safety of vapona.
[p. 59]
Representatives of PHS also attended the 1965 meeting. PHS rec-
ords indicate that Leary represented PRD at a September 2, 1964,
conference in Sacramento, Calif., at which representatives of the
California Department of Public Health expressed opposition to
registration of vapona for home use.
ARS-PHS differences concerning vapona and other vaporized
pesticides
Documents in ARS and PHS files reflect a considerable amount
of controversy between the two agencies relating to the continued
registration of vapona (DDVP) and lindane products. In June
1965, PHS wrote ARS to reaffirm its opposition to DDVP-impreg-
nated strips and lindane and pyrethrum vaporizing devices, em-
phasizing that it had decided to object to such usage patterns
"after consultation with numerous scientists and public health
officers about this problem." A July 23 reply from Dr. R. J. Ander-
son, then ARS Deputy Administrator, agreed that opposition to
use of vaporized pesticides in homes had "considerable merit from
the theoretical viewpoint;" Dr. Anderson stated, however, that
-------
1480 LEGAL COMPILATION — PESTICIDES
ARS did not have scientific evidence to support cancellation of
existing registrations for such pesticides and therefore did not
feel it was in a position to refuse to register new products of the
same type.
A meeting of ARS and PHS officials was held on August 6, 1965.
Subsequent correspondence between the two agencies indicates
that PHS officials believed an agreement had been reached for
formation of a joint committee to study problems relating to va-
pona strips, lindane, and pyrethrum vaporizers. ARS, however,
took the position that no such agreement had been reached and that
if a committee were set up it should be appointed by the National
Academy of Sciences. After ARS declined to participate in a joint
study, PHS decided to go ahead with its own ad hoc committee.
On October 13, 1965, before the meeting of the PHS ad hoc
committee, ARS notified PHS that, in the absence of scientific evi-
dence that presently registered DDVP uses were hazardous, it
intended to approve pending applications for additional registra-
tions for such uses. On November 15, 16, and 17, according to
PRD records, eight additional registrations for vapona products
were approved. Two of the registrations were issued to Shell;
the other six were issued to companies which planned to purchase
vapona from Shell. (It might be noted at this point that the
registrations were approved during Dr. Hansberry's service on
the task force studying PRD registration procedures.)
PHS committee opposes use of DDVP
The PHS Ad Hoc Committee on Vaporizing Devices met in
Washington on November 19, 1965. The eight committee mem-
bers present, according to the minutes, consisted of two scientists
from the National Institutes of Health, two from universities, two
from State health departments (California and New York) , one
from the PHS Communicable Disease Center (which had played
a prominent part in development of DDVP as an insecticide) , and
one from private industry. After deliberation, all eight committee
members recommended against use of lindane in vaporizing de-
vices. Six of the eight also recommended against use of DDVP
and pyrethrum vaporizers ; the two dissenters were the scientists
from the Communicable Disease Center and the one from private
industry.
[p
On September 22, 1966, the report of the ad hoc committee
meeting was sent by the Surgeon General to Dr. R. J. Anderson,
then Deputy Administrator of the Agricultural Research Service.
In the letter of transmittal, the Surgeon General stated that PHS
-------
GUIDELINES AND REPORTS 1481
had heard that USDA was considering referral of the matter to
the National Academy of Sciences, that PHS wished to endorse
such action, and that it would withhold its final recommendation
until the report of an NAS-NRC Committee was available. PHS
also offered to assist in arranging for an NAS-NRC study if
USDA so desired.
Meeting of PRD medical advisers
In early October 1966, Dr. Harry W. Hays, Director of the
Pesticides Regulation Division, asked three medical experts to
meet in Washington on October 26, 1966, to advise PRD on prob-
lems relating to vaporized pesticides. Although the report of the
PHS ad hoc committee on this subject had recently been received,
the subcommittee found no evidence that copies of the report were
provided to the medical consultants. PRD files indicate, however,
that they were given copies of a six-page memorandum prepared
for Dr. Hays by John S. Leary, Jr. The Leary memorandum, by
contrast with the ad hoc committee report, did not oppose contin-
ued registration of DDVP strips, lindane, and pyrethrum vapor-
izers. It did, however, suggest that such pesticide uses not be con-
sidered "air pollution" but be regarded as "air additives"—a term
defined as meaning substances which are introduced into con-
fined spaces in a highly controlled manner to produce a specified
and desirable result.
Dr. Hays advised the subcommittee staff that no minutes of the
October 26 meeting were kept. The subcommittee did find a No-
vember 3, 1966, letter from one of the participants (Dr. Ted A.
Loomis, professor of pharmacy, University of Washington) to
Dr. Hays indicating a belief that some suitable authority should
accept responsibility for stating whether or not the vaporized pes-
ticides were safe. The letter recommended referral of the matter
to the National Academy of Sciences, and indicated that such
referral had been discussed at the meeting.
Acceptance of position with Shell by John S. Leary, Jr.
On November 14, 1966, according to USDA records, John S.
Leary, Jr., resigned his position with the Pesticides Regulation
Division, effective December 31, 1966. In a personnel form dated
November 14, Mr. Leary gave his reason for leaving as "To accept
a position with the Shell Chemical Co."
USDA records examined by the subcommittee did not disclose
when employment negotiations between Mr. Leary and Shell
Chemical Co. began.
-------
1482 LEGAL COMPILATION — PESTICIDES
Leary opposes action against vapona strips
The subcommittee's examination of PRD files disclosed a memo-
randum from John S. Leary, Jr., as Acting Assistant Chief Staff
Officer, Pesticides Safety Advisory Staff, to Dr. Harry W. Hays
reviewing the report of the PHS Ad Hoc Committee on vapor-
ized pesticides. The memorandum is dated December 6, 1966, 3
weeks after Mr. Leary notified USDA that he was leaving to
accept employment with Shell Chemical Co.
r
The Leary memorandum, after criticizing various aspects of
the ad hoc committee's work, stated that "The report of the com-
mittee serves no useful purpose." The memorandum recommended
that the report "should be set aside as inadequate justification for
any change in the registration status of these methods of pest
control."
Leary represents Shell at 1968 meeting on vapona strips
On March 27 and May 29, 1968, Harold Alford, Assistant Di-
rector for Registration, Pesticides Regulation Division, stated in
letters to Shell Chemical Co.'s Washington office that a warning
against use in rooms where infants or infirm individuals are con-
fined must appear on the label of Shell's vapona strip. Registra-
tion No. 201-136. (Circumstances leading to the letters will be
discussed further later in this report.) On June 12, 1968, L. E.
Mitchell of Shell wrote Alford indicating that Shell would like
to discuss this matter with Dr. Hays and would contact him for
an appointment in July, at which time Shell personnel who had
been doing research overseas on vapona were expected to be in
the United States.
The subcommittee's investigation disclosed that a meeting
between Shell representatives and Dr. Hays and Mr. Alford of
PRD on the above matter took place on July 15, 1968. Dr. Hays
and Mr. Alford advised subcommittee staff members that there
were no minutes for the meeting, but that Mr. Leary had been
there and had taken an active part in it. Correspondence in PRD
files also indicates that Mr. Leary was present and that he had
submitted material relating to the safety of vapona strips. The
subcommittee found in the PRD file for Registration 201-136 a
document entitled "Vapona Human Study Evaluation : Literature
Review" dated April 26, 1968, which argues that use of vapona
strips without a warning for infants and infirm individuals
"offers no hazard to human health." A sheet of paper attached to
the front cover bore the written notation "Review submitted by
Mr. Leary, July 15, 1968."
-------
GUIDELINES AND REPORTS 1483
ACTIVITIES OF DR. MITCHELL R. ZAVON
Utilization of same medical consultant by both Shell and PRD
A number of individuals represented Shell Chemical Co. in
dealings with Federal agencies relating to vapona strips. One of
the most active of these was Mitchell R. Zavon, previously iden-
tified as a consultant to both Shell and the Pesticides Regulation
Division.
Dr. Zavon, a graduate of Harvard Medical School, served with
the Public Health Service from 1950 to 1957. Since that time he
has been associated with the Kettering Laboratory of the Univer-
sity of Cincinnati College of Medicine and has also served as
assistant health commissioner for the city of Cincinnati. USDA
records indicate that, except for three interruptions totaling about
11 weeks, Dr. Zavon was on the rolls as a consultant to the Pesti-
cides Regulation Division continuously from March 13, 1963 until
June 30, 1969. In testimony before a Senate committee on June
25, 1963,89 Dr. Zavon stated that he was a consultant to Shell
and the relationship apparently has continued to the present time.
Dr. Zavon's 1963 testimony was presented in his capacity as chair-
man, toxicology committee, National Agricultural Chemicals As-
sociation ; the as- r
sociation was described by its president as a nonprofit organiza-
tion formed in 1963 "to promote the interests of manufacturers
and formulators of pest control chemicals in a manner consistent
with the public interest."
Clearance of Zavon appointment
For the purposes of sections 207 and 208, the Federal conflict-
of-interest laws, a person who is appointed to perform temporary
duties either on a full-time or intermittent basis for not more than
130 days during any period of 365 consecutive days is classified as
a "special Government employee ;" this classification applies with-
out regard to whether or not such employee receives compensa-
tion for his services.90
The law does not prohibit a special Government employee who
is employed by or has a financial interest in a private firm from
transacting business with the Government on behalf of that firm
so long as it is unrelated to his present or past Federal employ-
ment. However, it does prohibit him from participating personally
and substantially as a Government employee in a matter in which
89 Subcommittee on Reorganization and International Organizations, Senate Committee on
Government Operations.
9018 U.S.C. 202(a).
-------
1484 LEGAL COMPILATION—PESTICIDES
the firm has a financial interest. It also prohibits a special Govern-
ment employee who participates personally and substantially as an
employee in a matter involving a specific party or parties in which
the United States is a party or has a direct and substantial interest
from representing anyone other than the United States in con-
nection with such matter after his employment has ceased.91
Under Federal personnel policies, departments and agencies do
not normally appoint an individual to serve as a consultant, ad-
viser, or other temporary intermittent employee for periods of
more than 365 days; it is not uncommon, however, for such an
individual to be reappointed after expiration of an appointment.
Before making such appointments, each Federal department and
agency is expected to make its best estimate of the number of days
during the following 365 on which it will require the services of
the appointee; if the estimate is more than 130 days, the ap-
pointee is not to be carried on the rolls as a special Government
employee.
USDA records indicate that Mitchell R. Zavon was appointed
a consultant to the Pesticides Regulation Division in March 1963,
and was regularly reappointed—usually for 1-year periods—
thereafter. In some instances, Dr. Zavon's service was not con-
tinuous because a current appointment expired a few days before
the effective date of reappointment.
In April 1964, in connection with a proposed 1-year reappoint-
ment of Dr. Zavon, a financial statement showing his connection
with Shell Chemical Co. was forwarded to the Office of General
Counsel for review. After reviewing the financial statement, Elmer
Mostow, then Director of the OGC Research and Operations Di-
vision, advised that a presidential memorandum on conflicts of
interest be brought to Dr. Zavon's attention. On April 7, 1964, the
USDA Office of Personnel informed the ARS Personnel Division
of Mr. Mostow's advice on the Zavon matter and stated:
Please see to it that the President's memorandum "Pre-
venting Conflicts of Interest on the Part of Special Govern-
ment Employees," May 2, 1963, is especially called to his
[p. 63]
attention so that he may avoid any possible conflict of interest
between his official duties as a consultant for the Department
and as a consultant for the Shell Chemical Co.
Dr. Zavon was reappointed for another 1-year period in May
1965. As indicated earlier in this report, the Office of General
»l 18 U.S.C. 207, 208.
-------
GUIDELINES AND REPORTS 1485
Counsel again advised that the conflict-of-interest laws and regu-
lations be specially called to Dr. Zavon's attention, and the USDA
Office of Personnel again asked the ARS Personnel Division to
take such action. USDA records did not indicate that similar ac-
tion was taken after 1965.
Zavon scientific work relating to safety of vapona
The subcommittee investigation disclosed that Dr. Zavon, either
individually or with others, conducted a number of studies relat-
ing to various aspects of the safety of vapona. Published and un-
published reports of some of these studies, as well as private com-
munications from Dr. Zavon, were cited by Shell from time to time
to support its contention that vapona strips were safe and that
no special warning for infants and infirm persons was needed.
Shell also made use of studies relating to vapona performed by
other scientists associated with the Kettering Laboratory.
One instance in which Dr. Zavon carried out studies on vapona
occurred in 1964. On March 20, 1964, Dr. Zavon wrote John S.
Leary, Jr., of the Pesticides Regulation Division referring to "our
recent conversation," enclosing descriptions of four proposed
studies of vapona strips, and asking Leary for any comments he
might care to make on the proposed studies. One of the studies
was for the stated purpose of determining whether detectable
food contamination occurs from use of vapona strips in restau-
rants.
According to a November 9, 1964, report prepared by Shell
(RES 64-112), the food contamination study involved collection
from a Hamilton, Ohio, restaurant of food samples which had been
exposed to vapona strips for 1 and 2 hours. The samples were col-
lected under Dr. Zavon's direction in August 1964, and sent to
the Shell Development Co., Modesto, Calif., for analysis. No resi-
dues of vapona were found, according to the report. (As has pre-
viously been noted in this report, studies performed by others did
disclose residues resulting from use of vapona strips around
food.)
Zavon participation in USDA advisory committee meeting on va-
pona strips
The subcommittee investigation disclosed that Dr. Zavon's ac-
tivities on behalf of Shell with respect to vapona strips were obvi-
ously not limited to conducting scientific studies. The subcommit-
tee found evidence of numerous contacts by Dr. Zavon with Govern-
ment officials relating to vapona strips.
Files of the Public Health Service contain notes indicating that
-------
1486 LEGAL COMPILATION—PESTICIDES
a meeting at which vapona strips were discussed was held on
April 14, 1965. The notes indicate that participants were Dr.
Zavon, John S. Leary, Jr., two representatives of the Public
Health Service, and three employees of Shell. Dr. Zavon presum-
ably attended the meeting in his capacity as a consultant to Shell;
the subcommittee found no indication in USDA files that Dr.
Zavon was acting as a consultant to the Pesticides Regulation Di-
vision on that occasion. r - ...
[p. 64]
The situation was different at a June 9, 1967, meeting of the
Pesticides Regulation Division Advisory Committee. The agenda
for the meeting lists the members of the committee as Drs. Victor
A. Drill, Bertram D. Dinman, Ted A. Loomis, and Mitchell Zavon.
Seven items were listed on the agenda. Items number 3 and 4,
respectively, were "Report on Pyrethrum Vaporizers" and "Lin-
dane Vaporizers and DDVP Strips." Minutes of the meeting con-
tain the following statement relating to discussion of lindane va-
porizers and vapona strips:
Dr. Hays said we are still getting reports of adverse reac-
tions from the use of these devices and he raised the question
as to whether continuous use of DDVP in a home is needed
to control flies. There was considerable discussion regarding
lindane and DDVP with no definite conclusions being reached.
USDA records indicate that Dr. Zavon's travel expenses from
Cincinnati to Washington and return were paid by the Depart-
ment of Agriculture and that Dr. Zavon was paid 2 days per diem
to cover other expenses in connection with the June 9 meeting.
Zavon contacts with Public Health Service
The subcommittee investigation established that Dr. Zavon, a
former medical officer in the Public Health Service, had frequent
contacts with PHS personnel in Atlanta and Washington relating
to vapona. These contacts occurred both before and after Dr.
Zavon's participation in the June 9, 1967, Pesticides Regulation
Division Advisory Committee meeting.
Shell opposes PHS study; referral to NAS discussed
Correspondence in PHS files indicates that Shell Chemical Co.
actively opposed having the safety of vapona strips studied by
either a joint USDA-PHS committee or the PHS ad hoc committee
which eventually examined the question. Shortly before the ad
hoc committee met, Shell complained to the Surgeon General about
the attitude of personnel of the PHS Office of Pesticides toward
vapona strips and other vaporizing type pesticides and suggested
-------
GUIDELINES AND REPORTS 1487
that, if any study were to be made, it should be by the National
Academy of Sciences.
Insofar as the subcommittee is aware, the report of the ad hoc
committee, based on its November 19, 1965, meeting, never was
released publicly. However, the position of the committee appar-
ently was no secret to the pesticide trade. The November 29, 1965,
issue of Food Chemical News reported that the committee had
concluded that the use of pesticide vaporizers in the home was
dangerous and that PHS would recommend to USDA that such
registration be discontinued.
By the time the ad hoc committee report was formally trans-
mitted to USDA by the Surgeon General on September 22, 1966,
reports were already circulating that USDA would ask for an
NAS study. As previously noted earlier in this report, the Surgeon
General stated in his letter of transmittal that PHS had heard
USDA was considering referral of the matter to the National
Academy of Sciences, that PHS wished to endorse such action,
and that it would withhold its final recommendation until an
NAS-NRC report was available. Referral to the National Academy
of Sciences was also discussed at the October 1966 meeting of
the Pesticides Regulation Division's medical advisers.
[p. 65]
Supervisory responsibility for label review transferred to Com-
municable Disease Center
Around 1949, the Communicable Disease Center of the Public
Health Service established a toxicology laboratory at Savannah,
Ga., for the purpose of testing and recommending the most effec-
tive and safest pesticides for the control of human disease. The
toxicology laboratory was associated with the PHS Technical
Development Laboratories, which were to become active in the
development of DDVP. The toxicology laboratory was moved to
Atlanta, Ga., in 1960 as a part of the technology branch of the
Communicable Disease Center, which had its headquarters there.
Until August 1966, PHS review of pesticide labels proposed
for registration was carried out by the Office of Pesticides, a
Washington-based unit of the PHS Bureau of State Services. At
that time, supervisory responsibility for PHS label review activi-
ties was transferred from the Bureau of State Services in Wash-
ington to the National Communicable Disease Center in Atlanta.
Actual review of proposed pesticides registrations continued to
be performed by a unit in Washington headed by Dr. Thomas H.
Harris; Dr. S. W. Simmons of CDC became overall head of the
pesticides program.
-------
1488 LEGAL COMPILATION—PESTICIDES
Dr. K. D. Quarterman, an official of the Communicable Disease
Center, had been one of the two members of the ad hoc committee
who favored continued registration of DDVP strips. In advocat-
ing his minority position, Dr. Quarterman had argued that CDC
had devoted a considerable effort over a period of years to devel-
oping the concept of using insecticidal vapors for control of disease-
carrying insects and that any adverse action with respect to regis-
tration of DDVP strips would tend to nullify these efforts.
Zavon requests "re-review" of vapona strips by PHS
On December 21, 1966, Dr. Zavon wrote then Assistant Sur-
geon General Richard Prindle about the report of the Ad Hoc
Committee. Zavon noted that the report had never been made pub-
lic, but stated that "enough information about its contents has
circulated to cause me to write to you about the matter." Dr.
Zavon transmitted with his letter a copy of a report on "some of
the work my associates and I have done recently" to evaluate the
use hazard of DDVP strips. Dr. Zavon went on to endorse DDVP
"as a Health Officer" (Dr. Zavon is assistant health commission
for the city of Cincinnati) and to suggest that the entire matter
of pesticide vaporizers "be re-reviewed by the Public Health
Service with opportunity provided for those with experience with
these devices to present all of the available information for re-
view." Dr. Zavon's letter made no reference to his relationship
with Shell Chemical Co.
Public Health Service files contain a number of letters written
by State and local health officers to raise questions about or ex-
press opposition to the use of DDVP strips. However, the Zavon
letter is the only instance known to the subcommittee in which a
health officer wrote PHS to endorse the use of DDVP strips.
Dr. Zavon's letter of December 21,1966, was referred to Atlanta
for reply. On January 4, 1967, Dr. S. W. Simmons, Chief of the
pesticides program, wrote Dr. Zavon to advise him that, shortly
after taking over the Office of Pesticides, CDC had recommended
to USDA that the matter be turned over to the National Academy
of Sciences-
[p. 66]
National Research Council. Dr. Simmons further advised Dr.
Zavon that CDC understood this had beeh done.
Zavon negotiates agreement with PHS on vapona strips
Documents in HEW and USDA files indicate that the Public
Health Service agreed to withdraw its objection to registration of
pyrethrin vaporizers, at a March 1967 meeting in Atlanta with
-------
GUIDELINES AND REPORTS 1489
USDA representatives, but recommended a precautionary state-
ment on the label against exposure of infants, ill and aged per-
sons. The addition of such a precautionary statement apparently
was approved by industry representatives at a June 27 meeting
in Atlanta, according to a PHS document summarizing the
meeting.
On August 21, 1967, Dr. Zavon wrote Dr. David W. Sencer,
Director of the Communicable Disease Center, to confirm a tele-
phone conversation earlier in the month. In the letter, Dr. Zavon
indicated that there was a reluctance on the part of some State
and local health officers to allow use of DDVP strips because of
a belief that PHS did not actually agree with the use pattern as
registered by USDA. Dr. Zavon enclosed copies of a recently com-
pleted report on a 1-year study of the effect of DDVP strips on
humans. Dr. Zavon further stated that, if the matter could not be
cleared up by correspondence, he and the responsible people from
Shell Chemical Co. would be available to discuss it.
A September 12, 1967, flle memorandum written by Milton J.
Foter, Deputy Chief of the pesticides program, to the Chief, Dr.
S. W. Simmons, indicates that Dr. Zavon was in Atlanta on Au-
gust 28 and 29 during Dr. Simmons' absence to discuss the PHS
position relative to a cautionary statement on the label of vapona
strips. The memorandum further indicates that Mr. Foter and
Dr. Wayland J. Hayes, then Chief Toxicologist for the pesticides
program, suggested the label bear the warning "Do not use in
nurseries or rooms where infants, ill or aged persons are con-
fined." In addition, the memorandum indicates that Dr. Zavon
called Dr. Simmons on September 7, 1967, to discuss the matter
and had called Mr. Foter on the morning of September 12. Ac-
cording to Mr. Foter, Dr. Zavon had discussed the proposed warn-
ing with representatives of Shell Chemical Co., and they had
proposed that the warning read "Do not use in rooms continuously
occupied by infants and infirm individuals." Dr. Zavon had re-
quested, according to Mr. Foter, that he be advised by telephone
whether the proposed alternative labeling was acceptable and
be sent a copy of a typical letter being used to answer inquiries
from State health agencies relating to vapona strips.
PHS files contain a copy of a September 11, 1967, letter from
Dr. Simmons to the North Carolina State Board of Health stating
that personnel of the PHS pesticides program had talked with
USDA and Shell Chemical Co. representatives concerning vapona
strips. Dr. Simmons further stated that he believed Shell would
soon resubmit their label to include the warning "Do not use in
-------
1490 LEGAL COMPILATION—PESTICIDES
rooms continuously occupied by infants and infirm individuals,"
and that PHS would have no objection to use of vapona strips with
such a warning1. PHS files indicate that a blind carbon copy of
the September letter was sent by Dr. Simmons to Dr. Zavon on
September 12, 1967, with a covering note stating that "I believe
this is along the lines of our conversation of several days ago."
[P. 67]
USD A refuses to accept labeling proposed by Shell
On Oct. 24, 1967, C. G. Green, Washington representative for
Shell Chemical Co. wrote to H. G. Alford, PRD Assistant Director
for Registration, requesting approval of a number of changes in
the labeling for Shell's "No-Pest Strip"; one of these was the
inclusion of the cautionary statement proposed by Shell and agreed
to by Dr. Simmons. On November 15, 1967, Mr. Alford wrote
Shell to advise that inclusion of the word "continuously" in the
statement was not acceptable; Alford's letter indicated that the
matter had been discussed in a recent conference. On December
11, 1967, Shell again wrote Alford stating that the company was
submitting new data on vapona which it felt eliminated the need
for the caution statement and wished to withdraw the request
for a change in labeling. The December 11 letter was signed for
Shell by L. E. Mitchell, division representative; a copy bore the
initials JSL, presumably indicating it had been drafted by John
S. Leary, Jr.
Events reflected in the above correspondence are consistent
with statements in a brief submitted to the subcommittee by Shell
Chemical Co. In the brief, Shell states that it reached agreement
with PHS on a cautionary statement through the company's medi-
cal consultant, Dr. Mitchell R. Zavon, but that USDA had insisted
on deletion of the word "continuously." 92
Further Zavon contacts with PHS officials in Atlanta
A December 14, 1967, memorandum by Mr. Foter to Dr. Sim-
mons states that Dr. Zavon called on December 13 and talked with
Mr. Foter in Dr. Simmons' absence. Dr. Zavon stated, according
to the memorandum, that Dr. Harry Hays of the USDA Pesticides
Regulation Division "did not see the need" for revising the vapona
strip label to include precautionary statements as previously dis-
cussed with PHS. In order to resolve the situation, Mr. Leary had
written a letter to Dr. Hays with new data on the lack of toxicity
of DDVP and Dr. Zavon had asked Mr. Leary to send a copy of
the material to Dr. Simmons.
•2 Hearing record, p. 309.
-------
GUIDELINES AND REPORTS 1491
Mr. Foter also advised Dr. Simmons that Dr. Zavon told him he
had received information that the President's Office of Science
and Technology had been requested to review the whole prob-
lem of pesticide vaporizing devices. According to Foter, Dr. Zavon
stated he was not certain of the reliability of his information and
encouraged them to make "discreet inquiries" about the matter.
The Foter memorandum also indicated that Dr. Zavon had visited
the pesticides program offices in Atlanta on November 28 and
29, 1967.
During December 1967 and early January 1968, there was
apparently some confusion on the part of the pesticides program
registration staff as to the wording of the cautionary statement
to be required for vapona strips. (Personnel of the registration
section had not participated in the Atlanta discussions relating to
the matter.) The registration section informed USD A in comment-
ing on proposed registrations for DDVP products that "We
would not object to registration or reregistration of these prod-
ucts if the label bore the statement 'Do not use in nurseries or
homes where infants, ill, aged or debilitated people are housed.'"
On January 16, 1968, Dr. Simmons sent Dr. Thomas Harris,
chief of the registration section, a memorandum instructing that
inquiries [p 6g]
about vapona strips should be answered by a statement
that the pesticides program had no objection to use of the devices
in accordance with label instructions, with the additional pre-
cautions : "Do not use in rooms continuously occupied by infants
and infirm individuals." A second memorandum sent the same day
contained the same instructions with respect to use of pyrethrum-
piperonyl butoxide aerosol dispensers, except that a stronger pre-
cautionary statement was to be required as follows: "Do not use
in nurseries or rooms where infants, ill or aged persons are
confined."
A further exchange of correspondence between Dr. Zavon and
Dr. Simmons in early February indicates that Mr. Leary had been
in Dr. Simmons' office and had been shown a copy of the January
16 memorandum on vapona strips. A copy of the memorandum
was also sent to Dr. Zavon on February 8, 1968.
Shell personnel meet with officials of Pesticides Regulation
Division
Additional notices that a warning against use of vapona strips
where infants or infirm individuals might be exposed must ap-
pear on the label were sent Shell by PRD in March and May, 1968.
-------
1492 LEGAL COMPILATION—PESTICIDES
On July 15, 1968, Shell representatives, including John S. Leary,
Jr., a former PRD official, met to discuss the matter with Dr.
Hays and Mr. Alford of PRD. Details of this meeting have been
discussed previously.
On August 7, 1968, M. J. Sloan, manager of regulatory affairs
for Shell Chemical Co., wrote Dr. Harry Hays to submit further
data on vapona strips. In the letter, Mr. Sloan referred to previous
scientific reports "which our medical consultant, Dr. M. R. Zavon,
reviewed for you in our recent conference." Dr. Hays informed
the subcommittee staff that he did not remember whether Dr.
Zavon was present at the July 15, 1968, meeting but that it was
possible that he might have been.
Shell agrees to label warning
On September 10, 1968, a report by the Comptroller General
which sharply criticized past PRD enforcement procedures was
made public. On October 15, 1968, the General Accounting Office
submitted a draft of a proposed report on safety questions involv-
ing lindane vaporizers to USDA officials for comment. On Novem-
ber 27,1968. USDA advised GAO that a meeting of PRD's medical
consultants was being called to discuss the lindane situation. Fur-
ther details of these events have been discussed earlier in this
report.
On December 10, 1968, PRD notified Shell that it had reviewed
the additional data submitted on vapona strips and did not feel
the data supported continued use of the product in areas where
infants, aged or sick people would be continuously exposed; con-
sequently, the precautionary statement "Do not use in nurseries
or rooms where infants, ill or aged persons are confined" must
appear on the label. On December 12, 1968, Shell asked that they
be allowed to use a statement reading "continuously confined."
On January 2, 1969, PRD replied that the alternative wording
was not acceptable and that the original statement must be
promptly added to the label if registration of the product was to
be continued. Both PRD letters bore the signature of Dr. Hays;
symbols on the copies indicated the letters were drafted by Harold
Alford. On January 8, 1969, Shell wrote PRD that, while it did
not agree that the cautionary statement being demanded was
necessary, it would comply with PRD's requirement.
[p. 69]
1969 meeting of PRD medical consultants
On January 8,1969—the same day Shell finally agreed to PRD's
demand for a cautionary statement—PRD's panel of medical ad-
-------
GUIDELINES AND REPORTS 1493
visors met in New York. A March 17, 1969, report to Dr. Harry
Hays signed by Drs. Victor A. Drill, Bertram D. Dinman and Ted
A. Loomis summarized the advisory panel's opinions on questions
discussed at the meeting. The panel reported that it was their
opinion that the use of vaporized lindane by persons other than
qualified pest control operators in areas where food for human
consumption is stored or served created a hazard potentially det-
rimental to human health. Subsequent action taken by PRD to
cancel registrations for lindane products has been discussed
previously.
The March 17 report also indicated that safety of DDVP strips
was discussed at the January 8 meeting, and stated that "No
definitive consensus of opinion on this subject was achieved at the
meeting of the panel. The available data needs additional compar-
ative evaluation. The subject will be reconsidered at a subsequent
meeting."
Dr. Hays informed the subcommittee staff that Dr. Zavon was
not at the January 8 meeting in New York and that he himself
was the only person there other than the three persons signing
the report.
- After subcommittee hearings in May and June 1969, USDA took
action to require relabeling of Shell "No-Pest Strips" which were
being marketed without the cautionary statement called for under
its amended registration. USDA has also informed Shell (and
other distributors of DDVP strips) that an additional warning
against contamination of food must be added to the label. Details
of these actions were discussed earlier in this report.
Possible conflict-of-interest question involving dieldrin
When Dr. Zavon was initially appointed to serve as a USDA
consultant in March 1963, the description of his duties read in
part as follows:
* * * expert consultant on matters relating to industrial
toxicology to confer with and advise the Secretary, the Ad-
ministrator and Deputy Administrators of the Agricultural
Research Service, the Director of the Pesticides Regulation
Division, and other officials of the Department on the problem
of pesticide usage for plant pest control, specifically dieldrin.
Shell Chemical Co. is a basic producer of dieldrin. As such, it
has had a number of pesticide products containing dieldrin regis-
tered with the Pesticides Regulation Division since before 1963.
The subcommittee investigation did not disclose whether or not
Dr. Zavon actually advised USDA, as an expert consultant, on
-------
1494 LEGAL COMPILATION—PESTICIDES
any matter or matters involving dieldrin in which Shell had a fi-
nancial interest.
Referral of conflict-of-interest questions to Department of Justice
The subcommittee has been advised by the Department of Agri-
culture that possible conflict-of-interest questions involving Dr.
Hansberry, Mr. Leary and Dr. Zavon have been or will be referred
to the Department of Justice.
[p. 70]
QUESTION CONCERNING PATENT RIGHTS
On February 1, 1955, then Secretary of Health, Education, and
Welfare Hobby called a press conference to announce the discov-
ery by research scientists at the Savannah, Ga., laboratory of the
Public Health Service's Communicable Disease Center of a new
insecticide. The insecticide, DDVP, was described as "more potent
in killing insects than many modern economic poisons."
In August 1955, an article by Kenneth D. Quarterman, then
head of the CDC Savannah laboratory, was published in Public
Health Reports. The article contained the following paragraph:
It has been determined that the Federal Government is
entitled to the entire right, title, and interest in the invention
of DDVP. It was decided also that the Government should
not seek to obtain a domestic patent on the invention because
prior publications on the invention by the Government sci-
entists who developed it are deemed sufficient protection
against the prosecution of a successful patent application by
a later inventor. These publications will, within 1 year from
the first date of publication, constitute a dedication of the
invention to the public. Such a dedication adequately pro-
tects the interests of the Government. On the basis of this
determination and decision, any manufacturer who wishes to
do so may proceed with the domestic production of DDVP
in the United States without seeking a license from the
Government.
Despite the statements in the Quarterman article, Shell Chem-
ical Co. now claims exclusive U.S. patent rights to DDVP. The
subcommittee has not yet completed its examination of the circum-
stances on which this claim is based.
[p. 71]
-------
GUIDELINES AND REPORTS 1495
4.2c REPORT ON 2,4,5-T, A REPORT OF THE PANEL ON
HERBICIDES OF THE PRESIDENT'S SCIENCE ADVISORY
COMMITTEE, MARCH 1971
THE PRESIDENT'S SCIENCE ADVISORY COMMITTEE,
EXECUTIVE OFFICE BUILDING,
Washington, D.C., March 2,1971
The publication of this report on the herbicide, 2,4,5-T, symbolizes an area
of public policy decision-making in which science and, hence, scientists have
a large responsibility. The report itself is a landmark. It examines in detail
the scientific considerations leading to policy judgments about a pesticidal
chemical.
The foresight of Dr. Lee DuBridge, Science Adviser to the President at the
time this review was initiated in October 1969, is commendable. The Govern-
ment agencies charged with responsibilities for regulating pesticides and for
overseeing the integrity of the public's health, chose a course of regulatory
action in October 1969 which restricted some uses of 2,4,5-T. This action was
taken as a result of a new and unexpected research finding which emerged
from experiments sponsored by the Government. At that time, Dr. DuBridge
perceived the need for a thorough and critical review of all of the scientific
information available on the herbicide — including that dealing with biological
properties and human health.
Importantly, the report's recommendations already have been adopted by
the appropriate Government agencies and specific actions have resulted. The
original experiments were confirmed and extended by later research. A
potent impurity, a family of dioxins, has been the subject of several research
projects. These have taught us more about the herbicide's physical stability,
environmental persistence and biological properties. A recommendation for
a legislative mechanism to restrict temporarily the use of a pesticide on the
occasion of an unexpected research finding implicating it as a health hazard
(while further confirmatory research is performed) is reflected in the Admin-
istration's proposed legislation on pesticide regulation.
Although the report is concerned with highly technical matters, it does
allude to some policy issues. It compares the scientific evidence available, and
considered adequate, at the time of first registration of 2,4,5-T with the
much greater level of scientific understanding demanded today. The Panel
found evidence of measurable benefits from the use of 2,4,5-T but there was
simply very little information that could be used to assess risk. Based on its
experience in evaluating risks and benefits on the basis of incomplete infor-
mation, the Panel cautions that judgments on benefits and risks associated
with pesticidal chemicals require an unusual measure of prudence to assure
that the public is neither subjected to undue risk nor unnecessarily denied
the benefits of valuable chemicals.
The report does not speak in particular to the regulatory actions taken by
the Government on 2,4,5-T (although I am satisfied that the review comple-
ments them in every respect). If any of the Government actions appear diver-
gent from these recommendations, the divergence is consistently on the side
of prudence and avoidance of the possibility of hazard to human health, and
this is as it should be, for Government must act on the side of prudence. It
-------
1496 LEGAL COMPILATION—PESTICIDES
provides those of us concerned with pesticides, their economic value and
utility, their negative effects on the environment, and their other biological
effects, with an excellent case study. The principles brought out in this study
will be useful in dealing with other pesticides, and indeed with chemicals of
other kinds.
EDWARD E. DAVID, JR.,
Chairman
MEMBERS OF THE PANEL
DR. COLIN M. MACLEOD, Chairman, New York University Medical
Center, New York, New York
DR. JOHN D. BALDESCHWIELER, Stanford University, Stanford,
California
DR. NYLE C. BRADY, Cornell University, Ithaca, New York
DR. EMMANUEL FARBER, University of Pittsburgh, Pittsburgh,
Pennsylvania
DR. PAUL KOTIN, National Institute of Environmental Health
Sciences, Durham, North Carolina
DR. BRIAN MACMAHON, Harvard School of Public Health, Boston,
Massachusetts
DR. NORTON NELSON, New York University Medical Center, New
York, New York
DR. L. DALE NEWSOM, Louisiana State University, Baton Rouge,
Louisiana
DR. JOHN W. TUKEY, Princeton University, Princeton, New Jersey
DR. JAMES G. WILSON, Children's Hospital Research Foundation,
Cincinnati, Ohio
DR. EDWARD J. BURGER, JR., Staff, Technical Assistant, Office of
Science and Technology, Executive Office of the President,
Washington, D.C.
DR. DAVID PIMENTAL, Consultant, Office of Science and Technology,
Executive Office of the President, Washington, D.C.
[p. iii]
-------
GUIDELINES AND REPORTS 1497
CONTENTS
Page
Summary and Recommendations 1
Introduction 8
Chemistry 10
Synthesis 10
Formulation 11
Solubilities 12
Purity of Technical Grade Material 13
Analytic Methods 17
Chemical Stability of 2,4,5-T 21
Uses and Significance 25
Production 26
Uses 26
1. Domestic 26
2. Military 32
Cost Sharing Program 36
Toxicology 38
Acute Toxicological Investigations 39
Occupational Experience 42
National Cancer Institute Screening Study 42
Reports of Birth Defects 47
Toxicity of Dioxin 47
Teratogenesis Testing 49
Summary of Experiments 50
Residues of 2,4,5-T in the Environment 54
Residues of 2,4,5-T resulting from recommended uses in
the United States 54
Residues of 2,4-D and 2,4,5-T resulting from recommend-
ed uses by the military for defoliation 60
Some Ecological Effects 65
[p. vii]
SUMMARY AND RECOMMENDATIONS
SUMMARY
This review of the herbicide, 2,4,5-T, began with an examina-
tion of the results from an experimental screening study which
implicated it as a potential teratogen. It quickly became evident
that examination from such a restricted basis was inadequate.
Therefore, the Panel decided to study more broadly important
aspects of 2,4,5-T, including details of its chemistry and purity,
its domestic uses and their relative importance, the military sig-
-------
1498 LEGAL COMPILATION—PESTICIDES
nificance attached to 2,4,5-T as a defoliant, residue levels (in
order to estimate probabilities of human exposure), general
effects on the environment, as well as its toxicity. In examining
the toxicity of 2,4,5-T, the Panel reviewed the information avail-
able from the literature (as well as some unpublished documents)
which had been considered in the past in establishing policy deci-
sions for the various uses to which this pesticide had been put.
Selection of 2,4,5-T as an example for detailed examination has
had a number of advantages. There has been an extensive history
of use and experience. 2,4,5-T was first registered on March 2,
1948, by the Amchem Products Company, Ambler, Pennsylvania.
Since that time considerable information on its properties and
uses has accumulated. Furthermore, it has been the subject of
reviews by others in the past. Finally, the problem which brought
it to the Panel's attention, suspicion of teratogenicity, appears to
be a relatively manageable problem in contrast to many other bio-
logical effects, notably tumor production and genetic alterations.
This is important since the recommendations vrhich follow can
be made with a degree of confidence that cannot be applied to
carcinogenic or mutagenic effects. For example, the dose-response
characteristics of teratogens is generally restricted to a relatively
small range of dosage. Accordingly, a threshold below which no
effect would be expected can be assigned with more certainty.
Experiments to determine this range of values can be performed
in a relatively short time and do not require very large numbers
of animals.
The Panel is gratified that some of its recommendations are
already being carried out, especially further experiments to con-
firm and ex- r 1,
[p. 1]
tend the results of the original screening that indicated 2,4,5-T
to be teratogenic.
In considering the chemistry of 2,4,5-T, our attention was
drawn to impurities which can result from the manufacturing
process. Particular attention was focused on a single impurity,
2,3,7,8-tetrachlorodibenzo-p-dioxin, which occurs in commercial
preparations of the herbicide in highly variable amounts unless
particular care is taken to exclude it. This impurity is extremely
toxic. Its amount depends upon variations in the reaction condi-
tions. Other dioxins can be formed from various impurities in the
starting materials. The dioxin impurity came to particular atten-
tion when the U.S. herbicide industry was asked to produce larger
quantities of 2,4,5-T during the middle 1960's. However, its pres-
ence as an impurity and certain of its acute toxic effects had been
-------
GUIDELINES AND REPORTS 1499
known since 1957. Its concentration in commercial 2,4,5-T has
been greatly reduced in the past year or so.
Analytic methods available for 2,4,5-T are accurate and relia-
ble. With the possible exception of citrus fruits, determination of
residues in food has not presented a serious analytic problem.
2,4,5-T is relatively labile in nature. Residues in soils and water
are not persistent except under unusual conditions. The herbicide
is not stored in plants or animals to a significant extent.
Production of 2,4,5-T in the United States rose rapidly between
1960 and 1968. Civilian use, most of which is for clearing of
range land and rights-of-way and for treatment of pastures, de-
clined about 50% between 1964 and 1966. Military use of 2,4,5-T
as a defoliant, expressed as number of acres sprayed, rose sharply
between 1964 and 1967 but has declined since then. Although ac-
counting for only a small amount of the total usage of 2,4,5-T, its
place in control of aquatic weeds is significant. There is a small
but important list of agricultural uses where 2,4,5-T is applied
to food crops. Potential human exposure is recognized in this
direct application to food crops, in range and pasture lands grazed
by domestic meat and dairy animals, and possibly, in water sup-
plies derived from treated waterways and streams. The economic
importance of the various uses is considerable, but is very much
less than that of 2,4-D. Substitution of 2,4-D for 2,4,5-T can be
made for certain uses.
Defoliation, using mixtures of 2,4-D and 2,4,5-T, has been em-
ployed in Vietnam since 1962, more intensively since 1967.
Although not rigorously demonstrated, its military usefulness
has been considered to be very high.
The background of toxicological information on 2,4,5-T is thin.
Most of the animal studies have been concerned with acute toxic-
ity (single doses or repeated doses for short periods of time).
Based on these experiments, the acute toxicity of 2,4,5-T was
found to be low. Little is known of the details of the metabolic
handling of the material although rapid excretion in the urine
seems to be the rule. r ..
The screening study supported by the National Cancer Insti-
tute on the toxicity of certain pesticides and other important in-
dustrial chemicals marks an important advance in toxicological
testing in that the tests were designed to detect carcinogenic, tera-
togenic and mutagenic potential. The preparation of 2,4,5-T used
in those tests was shown to be teratogenic in both rats and mice.
There was no evidence that it was carcinogenic. While this study
had a number of limitations which qualified its usefulness, the
-------
1500 LEGAL COMPILATION—PESTICIDES
teratogenic results were sufficiently convincing so that the Panel
urged, early in its discussions, that they be repeated and extended
using better characterized preparations of 2,4,5-T. Analysis of a
sample of the 2,4,5-T preparation used in the original teratogene-
sis study revealed a dioxin level of about 27 ppm. Such a consider-
able contamination by this highly toxic material raised the ques-
tion as to whether the teratogenic effects observed were caused
by 2,4,5-T itself, by the dioxin impurity or by other impurities in
the commercial preparation tested.
The Panel was aware of press reports of increased birth defects
in Vietnam attributed to the use of defoliants. The lack of accu-
rate epidemiological data on the incidence and kinds of birth de-
fects in the Vietnamese population before or since the military
use of defoliants precludes any estimate as to whether an in-
crease in birth defects has occurred. Calculations of potential
human exposures from sources such as drinking water or direct
fallout make this appear unlikely (though theoretically possible).
A review of the environmental effects of 2,4,5-T on nontarget
organisms reveals few harmful consequences of its recommended
uses. Induced changes in vegetation are followed by alteration in
numbers of wild animals. Accelerated erosion of soil may follow
the killing of brush with herbicides but mechanical removal
causes greater erosion.
RECOM MENDATIONS
1. Further studies.
a. The animal experiments which raised the question of the
teratogenic potential of 2,4,5-T should be extended to include a
wider range of doses administered to non-inbred strains of ani-
mals and to larger numbers of animals.
b. The importance of the impurities in 2,4,5-T as potential
health hazards should be ascertained. Recent experiments de-
signed to distinguish between 2,4,5-T and the dioxin impurity
have suggested that both the herbicide and the dioxin are poten-
tial teratogens in some experimental animals. However, experi-
ments necessary to establish this answer have not been performed.
In addition, there may be additional impurities in commercially
prepared phenoxy herbicides which may be biologically active.
[p. 3]
c. The metabolism of 2,4,5-T in humans should be determined
and compared to that in experimental animals.
-------
GUIDELINES AND REPORTS 1501
2. The level of dioxin, a recognized impurity in 2,4,5-T, should
be rigorously controlled and limited to not more than 0.5 ppm,
A reduction to not more than 0.1 ppm should be urged. Several
polychlorinated dioxins have been found to be highly toxic and
capable of eliciting teratogenic effects, though they vary widely
in toxicity. Since they may reach the environment from multiple
sources, control over known sources should be exercised to the
extent possible.
3. A decision to restrict the use of 2,4,5-T should not be based
on the isolated finding of toxicity but on the expected exposure
following recommended use in relation to dose response effects.
In general, the imposition of restrictions on the use of a pesti-
cide would appear to be a function of two factors, the potential
for human exposure and the nature of the toxic effects. For ex-
ample, if carefully documented residue information points to little
likelihood of exposure, the risk of adverse effects would be less
significant than if exposure were widespread.
The Panel found no evidence to suggest that significant resi-
dues would result from recommended uses of 2,4,5-T on food
crops. It is possible for residues to occur in tissues of animals
grazing on recently treated pastures and range land. In fact, the
only residues which have been identified in the total diet studies
have occurred in meat and dairy products. However, the few cases
in which residues have been discovered have all been at levels well
below those which would be expected to result in significant tox-
icity for man.
The experimental finding of teratogenesis requires further elab-
oration before it can be interpreted as a human health hazard.
The risk of teratogenic effects should be placed in perspective.
Teratogenesis induced by chemicals is a fetal response at a par-
ticularly sensitive period in embryonic development to lower
doses of the chemical than are acutely toxic to the mother. Birth
defects can be produced in the embryo through many mechanisms
of injury when the agents are administered during critical periods
of organogenesis. It is generally held that by careful choice of
dosage, which may be close to the acutely toxic dose for the mother,
most chemicals might be shown to be teratogenic in animals. For
a variety of reasons, it is not possible to translate directly the
results of experiments in animals to man. There are differences in
sensitivity which arise from differences in metabolism. Compara-
tive metabolic studies in man and animals, therefore, are impor-
tant in interpreting toxicity for man.
-------
1502 LEGAL COMPILATION—PESTICIDES
The important consideration is not only the demonstration of
teratogenicity, which may occur with many chemicals at selected
dosages, but the estimation of the likelihood of teratogenic effects
with the amounts likely to be ingested incident to recommended
[p. 4]
use. To restrict or ban usage of chemicals on the basis of demon-
stration of teratogenicity at dose levels which far exceed actual or
expected exposures is unreasonable and could well deny usage of
chemicals whose benefits far outweigh risks.
4. Registrations of 2,4,5-T for uses on pastures and range lands
should be treated as registrations for food crop uses.
It is possible for residues of 2,4,5-T to occur in milk and tissues
of animals grazing on land recently treated with 2,4,5-T. To date,
meat and dairy products have been the only food products in the
total diet studies that contained measurable amounts of 2,4,5-T.
Use on range and pasture land should be included in registration
for use on food crops.
5. Monitoring of 2,4,5-T residues should be significantly ex-
panded, especially for meat and milk. In sampling meat and milk,
special attention should be given to geographic areas where
treatment of pastures and range lands with 2,4,5-T is most com-
mon. The 2,4,5-T residues that may occur in meat and milk of
animals allowed to graze on pastures and range lands treated
according to current recommendations should also be restudied.
6. As new information is developed on pesticides, it should be
disseminated promptly to individuals and organizations that are
legitimately concerned as manufacturers, formulators, users and
scientific investigators.
The case of 2,4,5-T is illustrative of inordinate delay in making
available new research information as it became known. The
screening study of pesticides which was carried out by Bionetics
Corporation under contract with the National Cancer Institute
was completed about August 1968. It was 14 months later when
the Government announced its coordinated actions on restricting
the use of 2,4,5-T. It was only after an additional several months
that the detailed data of the screening study were made publicly
available. A centralized mechanism for handling and disseminat-
ing new information about pesticides could help alleviate this
problem.
7. A mechanism should be established for restricting use of
a registered pesticide temporarily on the basis of information
-------
GUIDELINES AND REPORTS 1503
which implicates the chemical as a possible health hazard pending
the collection of more definitive information.
If a pesticide is already in established use, the decision is par-
ticularly difficult. Long established use inevitably implies a depend-
ence upon it by the consumer and a corresponding reluctance
by the manufacturer to withdraw it from the market.
At the present time, a registration may be held in abeyance only
by cancellation or suspension. Because of the serious import of
these actions they are put into effect with considerable reluctance.
They were not designed for situations such as the present with
respect to 2,4,5-T where temporary withdrawal from use, without
cancellation or suspension of registration, might have been a more
appropriate r cl
LP. oj
action. Such an alternative course of action is not possible under
present regulations.
There is need for a mechanism whereby the use of a pesticide
or other chemical that may affect human health can be tempo-
rarily restricted or held in abeyance. Such action would permit
the gathering of more definitive information in time for sufficient
consultation to permit a decision that would protect the public
health and not impose an undue economic burden on the producers,
marketers, and users of a product. Coincident with the imposition
of restrictions on a pesticide, a mechanism should be available for
informing and educating pesticide users and applicators so as to
make them more responsible agents. It is recognized that a change
in the law governing pesticides would be necessary to accommodate
this mechanism of a temporary restriction.
8. There is an urgent need for a focus of responsibility in
D/HEW to coordinate and monitor the toxicity and health activ-
ities related to effects of pesticides.
Information about the health effects of a pesticide derives from
a variety of sources including occupational exposures, residue
monitoring, toxicological investigations, clinical experience and
epidemiological studies. In the past, there has been no single focus
within D/HEW which has been concerned with all of these sources
of data and, more important, which has had the authority and
responsibility to coordinate new investigative initiatives. The
new Advisory Committee on Pesticides to the Secretary of D/HEW
can be expected to serve as a source of expert advice but cannot
fill the essential need for a focus of responsibility and authority
at the level of the Office of the Secretary. Consideration of the
functions to be fulfilled and the resources available suggests that
-------
1504 LEGAL COMPILATION—PESTICIDES
this responsibility should be assigned to the Assistant Secretary
for Health and Scientific Affairs because the various components
of D/HEW concerned most with aspects of the health effects of
pesticides report directly to him (National Institutes of Health,
Food and Drug Administration, National Communicable Disease
Center, Environmental Health Service) .*
9. Information provided in applications for registrations of pes-
ticides should take into account not only the pesticide for which
registration is sought but should identify other substances includ-
ing vehicles used in formulations, "inert" ingredients, and im-
purities.
Investigation of the synthesis of 2,4,5-T and examination of
the manufacturing process revealed that an extremely toxic im-
purity, 2,3,7,8-tetrachlorodibenzo-p-dioxin, present in variable
amounts in r fi-,
commercial preparations of 2,4,5-T, may account for some of the
toxicological characteristics assigned to 2,4,5-T itself. The pres-
ence of this impurity was recognized as early as 1957. However,
the importance of this impurity was not generally recognized in
the United States until after 1964. It appears logical that greater
specificity in identifying the components and properties of the
mixture of materials which are registered under a single name
would increase the probability of identification of potentially
toxic substances.
10. Registration procedures should be based on toxicological
studies of the particular compounds to be registered rather than
extrapolations from studies on related compounds.
Toxicological studies provided as information in behalf of
2,4,5-T registration were performed on a variety of related com-
pounds (the free acid, several types of esters and a variety of
salts). Results of these tests were regarded as being interchange-
able and applicable to the related compounds. There is evidence
to caution against this concept. The thorough testing of isomers,
esters, salts, and related compounds is a very large and expensive
task. Nevertheless, information about a potential health hazard
may be incomplete unless all of the compounds to be used are
tested. [p7]
• Since this report was written, the President established, through Reorganization Plan, the
Environmental Protection Agency which is to be responsible for broad areas of regulation
covering environmental matters. The Environmental Protection Agency will also have the
capacity to carry out some research under its name. Hence, we recognize that some of the
elements of coordination recommended in this section will be accommodated by this new agency.
-------
GUIDELINES AND REPORTS 1505
INTRODUCTION
In 1964, The National Cancer Institute undertook through a
contract a screening study of a number of pesticidal chemicals.
Among the results of this screening study was the finding that
birth defects could be provoked experimentally in rats and mice
by the administration of relatively large doses of the herbicide,
2,4,5-T. By the time these results were reported, 2,4,5-T had been
in common use as an herbicide for more than 20 years. Further,
it had been employed along with 2,4-D as a defoliant in Vietnam
since 1962, although in sizeable quantities only since 1967.
In October 1969 several agencies of Government moved in a
coordinated manner to bring about restriction of the use of 2,4,5-T
both within the United States and abroad (1). In terms of domes-
tic agricultural use, restriction was placed on the use of 2,4,5-T
on food crops pending the acquisition of further information that
might permit the Food and Drug Administration to grant a toler-
ance. Use as a defoliant in Vietnam was restricted to non-popu-
lated areas.
For a number of reasons, it seemed wise to explore this issue
in some detail. The most important of these reasons, perhaps,
was the desire to examine the scientific evidence available to stand
behind future policies governing the use of 2,4,5-T and to suggest
directions for further experimental research. Accordingly, a panel
of experts was assembled by the President's Science Adviser to
consider a number of aspects of a variety of herbicides some of
which where used as defoliants in Vietnam. The present report
represents their review of 2,4,5-T.
This review considers topics which are of concern to those who
are faced with policy decisions for 2,4,5-T. We hope that it can
serve as an example for the consideration of the health effects
and safety of pesticides and other chemicals purposefully placed
in the environment.
A number of issues are raised when the utility and safety of an
already existing material is questioned. It is elementary but
nevertheless true to say that the issues are complex. In a way,
their examination can be compared to following a seemingly end-
less and continuously branching program. The subject of how
much assurance of safety should be afforded is important.
Teratogenesis appears to be a more manageable problem than
some other health effects (such as tumor production). Prediction of
[p. 8]
safety can probably be made with reasonable assurance. In
-------
1506 LEGAL COMPILATION—PESTICIDES
addition, experiments to test a suspected substance are reasonably
straightforward to conduct.
Among other problems, the purity of the chemical became an
issue. In the case of 2,4,5-T separation of biological effects of the
principal material from those of the impurities turned out to have
unusual importance. For this reason, the resolution and accuracy
of analytic methods available and used to detect 2,4,5-T and its
impurities had to be evaluated. In ascertaining the probable haz-
ard to man of an agricultural chemical, its toxicity in absolute
terms must be related to the probabilities of human exposure.
Residue information on 2,4,5-T therefore was explored.
Finally, there remains a series of policy questions which are at
least as philosophical as they are technical, the most crucial one
being how wide a margin of safety should a society adopt for itself.
The panel also touched on a narrower aspect of this question by
posing an additional one. This is the practical problem, in the
case of a material already in use, of how the Government should
act in the interim between the time of acquisition of preliminary
experimental data which reveal a chemical suspect and the per-
formance of more definitive experiments which establish the risk.
REFERENCES
(1) Press Release on 2,4,5-T. Office of Science and Technology, October 29,
1969' [p. 9]
CHEMISTRY
SUMMARY
2,4,5-trichlorophenoxyacetic acid is produced commercially by
a process which begins with tetrachlorobenzene as starting ma-
terial. Technical grade 2,4,5-T is 90-92% pure acid. One of the
important impurities, a polychlorinated dioxin, results both from
impurities in the starting material and as side products of the
desired reaction. A large number of esters and amine salts of
2,4,5-T have been developed as well as a variety of formulations
in order to derive specific properties of volatility and solubility.
About one-half of this total production can be accounted for by the
2,4,5-T acid and its n-butyl ester. The free acid is practically
insoluble in water and, generally, the esters are slightly soluble.
The amine salts tend to be more soluble. Among other things,
penetration into the soil or leaching is a function of water solu-
bility.
In general, 2,4,5-T residues can be expected to be relatively
unstable materials in the environment. They are broken down by
-------
GUIDELINES AND REPORTS
1507
microbial action and by sunlight and esters are readily hydrolyzed
to the free acid. Available analytic methods for detecting residues
are quite sensitive. The sensitivity of gas chromatography with
microcoulometric detection is about 0.01 ppm (10 ppb). Detection
of residues in plant material appears to be uncomplicated by
bound or complexed residues with the possible exception of resi-
dues in the peels of citrus fruits.
CHEMICAL SYNTHESIS OP 2,4,5-T
The herbicide commonly known as 2,4,5-T or 2,4,5-trichlorophe-
noxyacetic acid has the chemical formula:
ci
CH2COOH
The usual starting material in the chemical synthesis of 2,4,5-T
is 1,2,4,5-tetrachlorobenzene which can be reacted with methanol
[p. 10]
and sodium hydroxide in an autoclave under high temperature and
pressure conditions to give the sodium salt of 2,4,5-trichlorophenol:
high temperature
high pressure
CH3OH
NaOH
CH.,
Cl
Cl
Na
[1]
(2,4,5-trichloroanisole)
2,4,5-trichloroanisole is presumed to be an intermediate in this re-
action. The high temperature and high pressure conditions of this
step are also favorable for the production of a variety of other
compounds from these starting materials. The choice of the proper
temperature and pressure, and the control of these conditions
throughout the reaction are critical for minimizing side reactions
and hence impurities in the final product.
The aqueous trichlorosodium phenoxide is next reacted with
chloroacetic acid under mildly alkaline conditions.
12]
This product is then acidified with H2S04 to produce 2,4,5-T.
>CH2COONa
H2SO.
'CHjCOOH
[3]
-------
1508 LEGAL COMPILATION—PESTICIDES
The conditions for reactions [2] and [3] are mild compared with
those required for the hydrolysis in step [1].
The acid reacts readily with a variety of alcohols to produce a
large selection of esters, and with amines to produce amine salts.
CH2COOH + ROH > C\~// X>—OCH2COOE
COMMERCIAL FORMULATIONS OF 2,4,5-T
The 2,4,5-T compounds used in commercial spray formulations
include the acid, salts, and a wide variety of esters and mixtures of
esters. These active components are then formulated with solvents
and other ingredients to produce a bewildering array of commer-
cial final products marketed under cryptic trade names.
2,4,5-T formulations are applied as solids or liquids. The solids
usually involve 2,4,5-T esters incorporated with clays, talcs, Fullers
[p. 11]
earth, mineral silicates, or fertilizers. One of the major hazards
in the use of 2,4,5-T is drift of the herbicide into areas where it is
not desired due to volatility of the formulation or drift of fine
particles in the wind. This hazard is reduced in one solid formu-
lation for which the active material is deposited on polystyrene
spheres with a very narrow and carefully controlled particle size
distribution.
The liquid formulations require a solvent. Typical organic
solvents are kerosene or diesel oil. In formulations that are mixed
with water for spraying, emulsifiers and surfactants are necessary
ingredients. A truly thorough attempt at estimation of the toxicity
of the several commercial preparations of 2,4,5-T should take into
account all of the added material, "inert" ingredients, vehicles
and impurities.
2,4,5-T is most commonly employed as an ester or amine salt
(Table 1). The n-butyl ester is used as a defoliant in Vietnam in
a 1:1 mixture with 2,4-D, known as Orange.
TABLE 1.—PRODUCTION AND VALUE PER POUND OF MAJOR 2,4,5-T FORMULATIONS—1967
[Drawn from U.S. Tariff Commission, 24]
Production Unit value
(1000 Ibs.) per pound ($)
2,4,5-Trjchlorophenoxy-acetic acid (2,4,5-T) 14,552 1.25
2,4,5-Trichlorophenoxy-aceticacid esters and salts, total 27,189 0.80
2,4,5-Trichlornphenoxy-acetic acid, n-butyl ester 19,422 0.68
2,4,5-Trichlorophenoxy-acetic acid, iso-octyl ester 4,653 1.16
All other (2,4,5-T esters and salts) 3,114 1.09
-------
GUIDELINES AND REPORTS 1509
SOLUBILITIES
The solubility of the herbicide compound used may be important
in determining the mechanism by which the toxic material enters
the plant. It also determines the nature of the vehicle to be used
in its dispersion.
The free acid form of 2,4,5-T is practically insoluble in water
(8). The sodium salt is only soluble to a limited extent (less than
3 %), a fact which precludes its use in the low volume application
technique which has become more and more widely used in recent
years.
The amine salts are considerably more soluble in water; how-
ever, they are somewhat difficult to prepare. Only the triethyl
and trimethylamine salts can be obtained in a concentrate of 4
Ibs. acid equivalent/gal, with satisfactory storage qualities. Fur-
thermore, the marked insolubility of the calcium and magnesium
salts of 2,4,5-T which are formed upon dilution with water
causes nozzle clogging during application. Therefore, these for-
mulations are not widely used. Ester formulations are most com-
monly used as oil-water emulsions.
The extent of leaching of various herbicide formulations was
tested by applying these in solution to the tops of soil containing
tubes. The depth of leaching could in general be compared with
solubility. For
[p. 12]
example, the amine salt of 2,4,5-T was taken to a depth of nine
inches whereas 2,4,5-T itself remains at three inches.
Aside from the herbicide itself, leaching of diesel oil, a vehicle
commonly used in herbicide application, might present a threat
to ground water quality. However, Lindin and Muller (cited in
13) sprayed diesel oil at rates of 50, 250, and 500 gal./acre, and
after sampling with a tube and leaching with rain water, they
found only 1.5-2 ppm of diesel oil in sandy loam above 2.5 inches.
TABLE 2.-2,4,5-T PRODUCT COMPOSITION
Percent by weight:
91.0±1.0 2,4,5-trichlorophenoxyacetic acid
0.5±0.1 2,4,5-trichloroanisole
2.0±0.5 5-methoxy 2,4-dichlorophenoxyacetic acid
2.0±0.5 2-methoxy 4,5-dichlorophenoxyacetic acid
0.3±0.1 2,4,5-trichlorophenol
3.0±0.5 bis-2,4,5-trichlorophenoxyacetic acid
0.3±0.1 2,5-dichlorophenoxyacetic acid
0.2±0.1 SO,
0.2±0.1 Sodium salt of 2,4,5-T
0.5±0.2 HiO
less than 1 ppm tetrachlorodibenz-p-dioxin (TDD).
-------
1510 LEGAL COMPILATION—PESTICIDES
PURITY OP TECHNICAL GRADE MATERIAL
Technical grade 2,4,5-T manufactured for agricultural applica-
tions typically contains 90 to 92% 2,4,5-trichlorophenoxyacetic acid,
and 8 to 10% impurities. The detailed composition of the technical
material given by one producer is shown in Table 3.
The 1,2,4,5-tetrachlorobenzene starting material for the 2,4,5-T
synthesis contains typically 3% other tetrachlorobenzene isomers
and other chlorinated benzenes. These impurities can contribute
to small amounts of a variety of other chlorinated products includ-
ing dichlorophenoxyacetic acids and other isomers of the trichloro-
phenoxyacetic acid, although these products were not listed by the
manufacturer as impurities (Table 3).
2,4,5-trichloroanisole,
iCH3
is proposed as an intermediate in step (1) of the manufacturing
process. Incomplete reaction of this intermediate accounts for its
presence in the final product. There is also a possibility that the
2,4,5-trichloroanisole intermediate can be hydrolyzed under the
conditions of step (1) to give methoxydichlorophenoxyacetic acid
as side products:
ci
Cl & N^V-OCH2COOH
H30
[p. 13]
OCH3
X ^
Cl
and 2,4,5-trichlorophenol,
results from the incomplete condensation of the sodium phenoxide
with chloroacetic acid in step (2) .
-------
GUIDELINES AND REPORTS 1511
Bis-2,4,5-trichlorophenoxyaceticacid,
ci
I H
%-O—C—COOH
Vci
is an important impurity because the chloroacetic acid used in
step (2) commonly contains some dichlorcacetic acid. The 2,5-
dichlorophenoxyacetic acid arises from small amounts of 1,2,5-
trichlorobenzene in the tetrachlorobenzene raw material. Some
sodium 2,4,5-T and sulfate ions are commonly carried into the
product from the acidification (step [3]).
The standard assay for technical grade 2,4,5-T is a simple
titration to give the acid equivalent of the product. On this basis
most manufacturers market a product that has 97 to 9S% acid
equivalent. Analysis for actual 2,4,5-trichlorophenoxyacetic acid
content by gas chromatography is less commonly given, although
a standard method exists. The Department of Agriculture reported
that the content of 2,4,5-T was often as low as 85 % in commercial
materials that meet the 97% acid equivalent specification. (22)
Gas chromatography is used to monitor trace impurities in proc-
ess control for step (1).
The impurities present in any commercial preparation of 2,4,5-T
depend strongly on the purity of the starting materials and the
reaction conditions. These can vary among various producers and
among batches for a given producer.
The detailed processing methods and purification procedures also
vary widely among the various producers. The variation in product
analysis has not been carefully documented, and the toxicities of
most of the impurit;es have not been tested. It is not prudent to
assume that the combined toxicity of the mixture of materials in
one preparation is representative of all of the preparations that are
widely used.
[p. 14]
One trace impurity produced in the manufacture of 2,4,5-T has
received considerable attention. Tetrachlorodibenz-p-dioxin, com-
monly known as TDD,
/\ ^o. /\
-Cl
I II II I
Cl-
-------
1512 LEGAL COMPILATION—PESTICIDES
is produced as a side product under the conditions of step (1).
Since this compound is known to be extraordinarily toxic, the his-
tory of the recognition and identification of this impurity is par-
ticularly interesting. Elucidation seems to have come from two
principal independent sources.
The sporadic occurrence of an impurity in specific lots of animal
feed in 1957 brought significant losses to poultry farmers in south-
eastern and central U.S. Chicks were afflicted with hydroperi-
cardium, and suffered gross kidney and liver damage. Empirical
tests for the presence of the "chick edema factor" were announced
by the FDA in 1966 (11). The test used electron capture gas chro-
matography to examine a fraction of a sample isolated from the fat.
The presence of a specific set of peaks with given retention times
indicated the presence of the factor. The empirical test is used as
a screening procedure. When the presence of the factor is indicated
by gas chromatography, a chick bioassay test is required for con-
firmation. The absence of the factor is a requirement of the edible
tallow used for making fatty acids that go into food emulsifiers.
The chick edema factor was identified by X-ray crystallography
as 1,2,3,7,8,9-hexachlorodibenz-p-dioxin in 1967 by Wootton of
Proctor and Gamble (25) from 4 mg of toxic material extracted
from 100 Ibs. of contaminated fat obtained from trade sources. The
toxicity of this compound and related compounds was reported by
representatives of the Food and Drug Administration in 1968 (11).
A clue to the possible origin of the dioxins was suggested in their
synthesis by condensation (21). Two molecules of 2,4,5-trichloro-
phenol condense directly to give TDD:
ci
Two molecules of 2,4-dichlorophenol condense to give the dichlo-
rodibenz-p-dioxln,
and mixtures of various isomeric chlorinated phenols give mixed
chlorinated dioxins.
[p. 15]
-------
GUIDELINES AND REPORTS 1513
The FDA group reported the following toxicities:
TABLE 3.—AFTER HIGGINBOTHAN, ET AL. (12)
Reactants
2,4-dichlorophenol
Chlorinated dibenz-p-dioxin1 . . . .
2,4,5-tncnlorophenol . . -
2,4,6-tnchlorophenol . - -
234 6-tetrachlorophenol
Pentachlorophenol
Reference toxic fat components
No. of Cl
dioxin
2
4
4
6
8
. .. Mixture
Chicken embryo
bioassay
MI/IE
500
0.05
0.25
5.0
1.0
5.0
3.0
percent
mortality
70
100
100
50
100
27
100
1 Mixed 3 and 4 chloro species.
The tetrachloro species, which will be the important product
from the condensation of 2,4,5-trichlorophenol, requires only 0.25
/j.g for 100% mortality in the chick embryo bioassay. A mixture
of the tri- and tetrachloro species was reported in one study to
be more toxic than the tetrachloro species alone (12). However,
more recent unpublished observations by the same authors have
pointed toward a singularly high degree of toxicity of the four
chlorine members of the family. The conditions required for the
production of the tetrachlorodibenz-p-dioxin, TDD, are present
in step (1) of the commercial 2,4,5-T synthesis, so this material
can be present in the original herbicide. Members of the family
of dioxins have been recognized in a variety of environmental
situations. The origins of these are not clear in every case (23).
The second source of information about the toxicity of dioxin
compounds came from observations of occupational exposures in
plants manufacturing 2,4,5-T. These are reviewed in another
section of this report. One of the diseases reported was a particu-
larly refractory form of skin rash known as chloracne. This was
also seen in workers involved in the production of other com-
pounds. The first report of chloracne in 2,4,5-T plant workers
was in 1957 (14). The authors in this case suggested that the
dioxin impurity may have been the factor which caused the
chloracne.
In 1964, the Dow Chemical Company (6) attempted to increase
the production of 2,4,5-T by changing the reaction conditions.
Plant operators became aifected with chloracne. The Dow Chem-
ical Company closed their facility and, early in 1965, alerted
other manufacturers of their problem. The active agent was
identified as 2,3,7,8-tetrachlorodibenz-p-dioxin. In addition, an
analytical method for its detection was standardized and various
methods for removing the impurity were devised. By 1965, suf-
ficient technology was available to allow the manufacture of
-------
1514 LEGAL COMPILATION—PESTICIDES
2,4,5-T and 2,4,5-trichlorophenol containing no more than 1 ppm
of 2,3,7,8-tetrachlorodibenz-p-dioxin. By 1966, a new Dow plant,
conforming to those specifications, was
[p. 16]
put into operation. TDD levels in technical grade 2,4,5-T from
another manufacturer are listed year by year in Table 4. Dioxin
levels in 2,4,5-T currently manufactured are reported not to
exceed 1 ppm.
TABLE 4.-HISTORY OF TDD CONCENTRATION IN TECHNICAL 2,4,5-T
[Analysis of material from one manufacturer]
Date ppm, TDD
1958
1959 _ _
1960 _
1961
1962
1963 _ _
1964 _
1965
1966 _ _
1967
1968...
1969_ ___ _
..._ 11
11
__ 8
. .. . 5
10
_. _ 11
12
._ 5-32
3-18
1-25
1-25
<1
ANALYTICAL METHODS
1. Standard Procedures.
A typical method for the analysis of herbicide residues in oil seed
crops has been described by G. Yip of the FDA (27). The method
involves extraction of 50 grams of oil with sodium bicarbonate solu-
tion, acidification, and extraction of the herbicides with chloro-
form. The herbicide residues in the acid form are then esterified
with diazomethane to produce the methyl esters which are finally
analyzed by programmed temperature gas chromatography. Both
electron capture and microcoulometric detection schemes are used.
The microcoulometric detector consists of a quartz tube condensa-
tion chamber where the herbicide is pyrolyzed at 800° C in the
presence of oxygen. The HC1 formed is carried into a microcoulo-
metric titration cell where the chloride is titrated with silver ion.
The sensitivity of this analytical scheme is about 0.01 ppm.
-------
GUIDELINES AND REPORTS
CONTROL
1515
2,3,6-TBA
PCP
0.02 PPM
MCPA
2,4-D
2.4,5-TP
2,4,5-T
2,4-DB
12 46 8 10 12 14 16 18 20 22
MINUTES
FIG. 1.—Gas chromatogram of the 0.02 ppm sample of herbicide mixture and
a control. Both curves represent 35 g of cottonseed oil.—After Yip (2?).
A gas chromatogram obtained from cottonseed oil treated with
a mixture of seven herbicides each at 0.02 ppm is shown in Fig. 1.
The seven herbicides used in this test of the method included:
-CH—COOH
2,3,6-TBA
2,4-DB
2,4.6-T
2,4,5-TF
[p. 17]
All of these residues are well separated and readily detected
after 22 minutes. Recoveries of these residues from the vegetable
oil samples were better than 90% in the 0.02 to 0.08 ppm range.
At the time this method was developed, samples of commercial
oils including cottonseed, corn, safflower, soybean, peanut, and
olive oils were analyzed for residues of these herbicides. No peaks
were discerned in the chromatogram of any sample.
Although the relative retention time of 2,4,5-trichlorophenol, a
common formulation impurity and one of the metabolic decom-
-------
1516 LEGAL COMPILATION—PESTICIDES
position products of 2,4,5-T was not reported, it should be less
than that of pentachlorophenol, and thus amenable to detection
by this scheme. (9)
Yip has also developed a paper chromatographic method which
allows qualitative determination of the same esters (28). A work-
able separation of the methylated acids was obtained using 35%
dimethyl formamide in ether as the immobile phase and 2,2,4-
trimethyl pentane as the mobile phase. The sensitivity of the paper
chromatographic technique is 0.1 ppm.
The procedure recommended by Yip (26) for analysis of resi-
dues on green crops involves high speed of blending finely chopped
greens with a mixture of H2S04, ethanol, petroleum ether and
ethyl ether. The solids are removed by centrifugation and the
liquid extracted with sodium bicarbonate and chloroform, as for
samples of vegetable oils. The procedure for wheat involves first
grinding the wheat kernels in a mill to pass a 30-mesh screen.
The ground wheat is then blended with 95% ethanol at high speed.
The solids are separated by centrifugalion and the residues ex-
tracted from the supernatant liquid as above.
2. Bound Residue. The above methods are adequate for the
analysis of 2,4,5-T residues that are in the form of the free acid
or various esters. The detailed analytical method provides steps
for the separate examination of the residues present in free acid
and ester forms although the esters are rarely found as residues
in crops.
[p. 18]
An issue of primary concern, however, is whether there can
exist in crops residues of 2,4,5-T chemically bound such that they
are not extracted and detected by the standard analytical method.
Crosby (4) showed that a water soluble, ether insoluble hydrolyz-
able form of 2,4-D is present in bean plants treated with 2,4-D.
It has been reported that 2,4-D as well as other herbicides can be
converted to coenzyme-A thioesters (3); this is a possible form
for the "bound" material. It has also been suggested that 2,4-D
may be bound as 2,4-dichlorophenoxy acetylglucoside (15). 2,4,5-
T could presumably undergo analogous reactions to give the cor-
responding bound forms.
The analytical method that has been used in most plant residue
studies provides no information on the fraction that may be
present in bound form. In a study of 2,4-D residues in forage and
milk, the residue levels shown in Tables 5 and 6 were found by
the standard analytical method (16) (29).
-------
GUIDELINES AND REPORTS
1517
TABLE 5.-RESIDUE OF 2,4-D IN FORAGE SAMPLES FROM PASTURES SPRAYED WITH BUTYL ESTER OR 2-ETHYL-
HEXYL ESTER OF 2,4-D AT A RATE IOF 2 LBS/ACRE. AVERAGE OF 1 TO 5 DETERMINATIONS—AFTER
KLINGMAN ET AL. (16)
2,4-D residues, ppm, from
Date, Ma)
6>
6' ..
8
10
13
Butyl ester
Acid
0
58.3
192
9.0
. 5.0
Butyl
ester
0
0.10
0.18
0.03
0
Ethyl
ester
0
0.04
0.02
0.03
0
2-ethylhexyl ester
Ethylhexyl
Acid ester
trace
36.6
38.6
23.8
13.7
0
11.8
6.7
2.0
1.4
1 Sampled just before spraying.
' Sampled within Vi hr after spraying.
Residues detected by the standard method were largely in the
form of the acid rather than the original esters. Some degradation
of the butylester to the ethyl ester apparently occurred. Essentially
no trace of residue was found in milk from dairy cows grazing
in pastures sprayed with 2,4-D (Table 6).
TABLE 6.—RESIDUE OF 2,4-D IN MILK, AS DETERMINED BY TWO METHODS OF ANALYSIS, FROM DAIRY COWS
GRAZING IN PASTURES SPRAYED WITH ESTERS OF 2,4-D AT 2 LB/A ON MORNING OF MAY 6,1963. SAMPLES
TAKEN FROM MORNING MILKINGS ONLY.1—AFTER KLINGMAN, ET AL. (16)
2,4-D residues in milk, ppm from
Date, May
6 ....
7
8
9
10
11
13
after butyl ester
FDA
«0 0
1 0.01
2 .01
3 .01
4 .01
5 .01
7 .01
SWRI
0
0.01
.01
.01
.01
.01
.01
2-ethylhexyl ester
FDA
0
0.01
.01
.01
!oi
SWRI
0
0.03
.02
'.01
.01
.01
1 Cows were kept in pastures continuously, except during milking. All data were rounded to nearest 0.01 because this
is about the practical limit of precision of the methods used. FDA=Food and Drug Administration and SWRI = Southwest
Research Institute.
* Milk was sampled in the morning before pastures weresprayed.
[p. 19]
The presence of bound 2,4-D in the grass samples from the
pasture sprayed with the ethylhexyl ester of 2,4-D was also
checked. To demonstrate the presence of bound 2,4-D, the acid
and ester were extracted from the forage samples as usual. The
filtrates were then extracted three times with ethyl ether to re-
move any residual 2,4-D acid and finally heated on a steam bath
for 16 hours under highly acidic conditions. Presence of bound
2,4-D would be indicated if amounts of 2,4-D found in the hydrol-
yzates were significantly higher than those found in the filtrates
before hydrolysis. Results are shown in Table 7.
-------
1518 LEGAL COMPILATION—PESTICIDES
TABLE 7.—PPM OF 2,4-D IN GRASS OF ETHYLHEXYL ESTER-SPRAYED PASTURE, FREE AND BOUND. (29)
Filtrates
Days after spraying Initial before Hydrolyzate
extraction hydrolysis
Control
2
4
7
46
50
- ... 20
19
0053
0.430
0.246
0230
/i\
0.54
1.31
1 Trace.
The presence of small amounts of bound 2,4-D is shown by the
value obtained from the hydrolyzates. There is a trend toward
increasing formation of bound 2,4-D with time. No bound resi-
dues could be detected in milk in these experiments. The results
from these experiments suggest that although bound residues
were detected, most of the residues were present as acid or ester
and there would not have been a major discrepancy between the
results of the standard method and the actual total residue
concentration.
There is evidence for the binding of residues of 2,4,5-TP
(Silvex), the phenoxy propionic acid analog of 2,4,5-T. A care-
ful study of 2,4,5-TP residues in orange peel, however, suggests
that a rather high percentage of the growth regulator residues
can be present as insoluble "bound" materials (10). 2,4,5-TP
fractions could be separated on the basis of solubility into four
types: free acid, ester (hexane soluble), complexed acid (water
soluble, hexane soluble), and heat-labile complexed acid (heat-
released). It was possible to detect the water soluble complexed
acid as the methyl ester after basic hydrolysis and identification.
The labile form was released after heating for 24 hours at 104-
105° C. The concentrations of these various forms during a 13-
week period are shown in Fig. 2.
r
Lp.
These results suggest that the original 2,4,5-TP amine salt is
first converted to the free acid. This acid then is converted to a
soluble conjugated form. However, it appears that the insoluble
complexed form ultimately becomes a major fraction of the total
residue. The results of this and other studies of herbicide residue
in citrus (7), (18) emphasize that the residues of halogenated
phenoxyacetic acids may take several forms in plant tissues.
Unless an effort is made to release the bound residues, the standard
analytical scheme does not provide a suitable basis for estimating
the total residue concentration.*
• It is possible that only the pure acid and ester residues produce physiological effects on
man and animals, while the bound forms are inert and non-toxic. The standard analytical
scheme would then provide a useful measure of the effective concentration of residue in toxic
form. The relative physiological effects of bound and unbound residues are unknown.
-------
GUIDELINES AND REPORTS
1519
CO
o_
Q.
UJ
9
Ul
Q_
eg
90
70
50
- C
O-FREE ACID
/*-SOL CONJ. ACID
O-HEAT LABILE ACID
10
1 3 5 7 9 11 13
WEEKS ELAPSED
FIGURE 2. — After Hendrickson and Meaghen (10).
CHEMICAL STABILITY OF 2,4,5-T
1. Photochemical Degradation.
Ultraviolet light has been shown to alter drastically the struc-
ture of many pesticides under laboratory conditions. Knowledge of
whether sunlight under "field conditions" can also affect these
transformations is critical. The detailed chemistry and toxicology
of the resulting decomposition products could be significant to agri-
culture and the public health.
Although the photochemistry of 2,4,5-T has not been investi-
gated, considerable effort has been expended to elucidate the path-
way for photochemical decomposition of 2,4-D. It might be expected
that these compounds react in a similar way. Several studies indi-
cated that rv,
LP-
2,4-D is, in fact, degraded in the presence of ultraviolet light
to phenolic products (19), (1), (2). Some evidence is available
which indicates that sunlight also detoxifies 2,4-D as Penfound
and Minyard (20) showed that malformations of water hyacinth
-------
1520
LEGAL COMPILATION—PESTICIDES
and kidney bean plants were more severe in shaded plants than in
those receiving full sun. The most recent photochemical study (5)
is the first to compare the transformations induced by sunlight and
ultraviolet light.
Photolysis in the presence of sodium bicarbonate (2xlO~3 M)
and water leads to several isolable products: 2,4-dichlorophenol,
4-chlorocatechol, 2-hydroxy-4-chlorophenoxy-acetic acid, and the
major product, polymeric humic acids.** Although the transient
1,2,4-benzenetriol could not initially be isolated, it could be trapped
if oxidation of this intermediate was inhibited by carrying out the
photolysis in the presence of excess sodium bisulfite.
These results suggest the following sequence:
OH
FIGURE 3. Proposed mechanism of 2,4-D photodecomposition
After Crosby (4)
Analogous results were obtained from irradiation in sunlight.
2. Hydrolysis.
The esters of 2,4,5-T are readily hydrolyzed to the free acid
under acidic or basic conditions. The esters are rarely found in
residues in crops. The rates of hydrolysis of course depend on the
detailed stereochemistry of the ester substituent. The rate of hy-
** No attempt was made to determine the fate of the two carbon fragment.
-------
GUIDELINES AND REPORTS 1521
drolysis is reduced as the bulk of the ester group is increased close
to the oxygen linkage. r 001
[p. ^J
3. Thermal Stability
2,4,5-T is stable with respect to thermal degradation to at least
its melting point of 153° C.
4. Biochemical Degradation.
2,4,5-T is slowly degraded in soil which contains organic matter
under warm, moist conditions. The generally accepted half-life
for this process is several weeks. However, the decay in 2,4,5-T
concentration is usually not a simple first order process since the
population of organisms that metabolize 2,4,5-T, increases in the
presence of 2,4,5-T. In areas pre-treated with 2,4,5-T, the lifetime
for degradation is significantly reduced. Three months appears
to be the accepted length of time for 2,4,5-T residues in soils to dis-
appear completely. The rate of disappearance appears to be inde-
pendent of the quantity of application. Some of the organisms re-
sponsible for 2,4,5-T biodegradation have been isolated and identi-
fied. (17) The subject of residues is more fully examined in Section
VI.
REFERENCES
(1) ALY, 0. H. and FAUST, S. D., J. Agric. and Food Chem. *2:541,1964.
(2) BELL, G. R., Botan. Gas. 118:133,1965.
(S) BORCH, M. K., Plant Physiology. 36:558,1961.
(It) CROSBY, D. G., J. Agric. and Food Chem. 12:2,1964.
(5) CROSBY, D. G., and TUTASS, H. 0., J. Agric. and Food Chem. 14:596, 1966.
(6) Dow Chemical Company, Personal communication.
(7) ERICKSON, L. C., BRANNAMEN, B. L., and COGGINS, C. W., J. Agric. and
Food Chem. 11:437,1963.
(8) FREAR, D. E. H., Chemistry of the Pesticides. 3rd Ed., D. Van Nostrand
Co., New York, 1955.
(9) GOVER-STRUL, G., KLEIGM, H. F. W., and MOSTAERT, H. E., Analytica
Chemica Acta 34:322, 1966.
(10) HENDRICKSON, R., and MEAGHER, W. R., J. Agric. and Food Chem. 17:
601,1969.
(11) HIGGINBOTHAM, G. R., RESS, J., and FIRESTONE, D. Chemical and Engi-
neering News 44:53,1966.
(12) HIGGINBOTHAM, G. R., HUANG, A., FIRESTONE, D., VERRETT, J., RESS, J.,
and CAMPBELL, A. D., Nature ZW :702,1968.
(IS) HOUSE, W. B., GOODSON, L. H., GADBERRY, H. M., and DOCKTER, K. W.,
Assessment of ecological effects of extensive or repeated use of herbi-
cides. Midwest Research. Institute. Project No. 3103-B, December
1967.
(14) KIMMIG, J., and SCHULZ, K., Dermatologica .795:540,1957.
(15) KLAMBT, H., Planta. 57:391,1962.
-------
1522 LEGAL COMPILATION—PESTICIDES
(16) KLINGMAN, D. L., GORDON, C. H., YIP, G., and BURCHFIELD, H. B., Weeds
14:164,1966.
(17) Loos, M. A. "Phenoxyacetic Acids," KEARNEY, P. C., and KAUFMAN, D. D.
(Ed.) Degradation of Herbicides. New York, Marcel Decker, Inc., 1965.
(18) MEAGHEK, W. R., J. Agric. and Food Chem. H :599,1966.
(19) PAYNE, M. G., and FULTS, J. L., Science 106:37,1947.
(20) PENFOUND, W. T., and MINYARD, V., Botan. Gaz. 109:231,1947.
(SI) TOMITA, M., VEDA, S., and NARISADA, M., Yakugaka Zasshi, 75:186,1959.
(22) U.S. Department of Agriculture, private communication.
[P.23]
(23) U.S. Department of HEW, FDA, personal communication.
(24) U.S. Tariff Commission, "Synthetic Organic Chemicals. U.S. Production
and Sales, 1967." Publication No. 295.
(25) WOOTON, J. C. Chem. and Eng. News, 45:10, 1967.
(26) YIP, G. J. Assoc. of Official Agricultural Chemists, 45:367,1962.
(27) YIP, G. J. Assoc. of Official Agricultural Chemists, 47:116,1964.
(28) YIP, G. J. Assoc. of Official Agricultural Chemists, 47:343,1964.
(29) YIF, G., and HEY, R. E., Jr., Weeds -Z4:167,1966.
[p. 24]
USES AND SIGNIFICANCE
SUMMARY
2,4,5-T has become important in land and waterway manage-
ment. It has been very useful for brush and weed control. A result
has been a growing dependence upon it. The Government itself has
encouraged the use of 2,4,5-T through an agricultural cost sharing
program.
Nearly 8 million acres were treated with 2,4,5-T in the United
States in 1964. The major use was brush control on rangelands,
pastures, and rights-of-way. Other uses were on certain food and
non-food crops, in aquatic weed control and in forestry.
In 1964 and 1966 almost half of the 2,4,5-T was used on rights-
of-way. Over two million acres of rights-of-way were treated in
1964 which is one quarter of the total area treated with this
herbicide.
Civilian uses of 2,4,5-T dropped nearly 50% from 1964 to 1966.
More recent, unpublished information from the Department of
Agriculture suggests that this trend continued through 1968 but
may have begun to reverse itself within the past year. This de-
crease accompanied price increases and shortages of supply asso-
ciated with the demand for 2,4,5-T as a defoliant and tactical
weapon in Vietnam. If acreage decreased proportionately, about
four million acres would have been treated in 1966.
To some extent, other herbicides can be substituted for 2,4,5-T
-------
GUIDELINES AND REPORTS 1523
(notably 2,4-D). If all alternative herbicides were available the
banning of 2,4,5-T would appear to lead to an additional cost of
nearly $52 million in land and waterway management or nearly a
100% increase over the current expenditures. These figures as-
sume practices designed to achieve the current level of manage-
ment and agricultural production. If other phenoxy herbicides are
also banned, the additional costs from elimination of 2,4,5-T alone
would amount to $172 million or over three times the present in-
vestment. Agricultural costs are estimated to rise $32 million and
$44 million, respectively, under the two assumptions, while costs
of right-of-way management would rise $12 million and $75 mil-
lion, respectively.
Agricultural production has become dependent upon the use of
herbicides. Their use in the United States has increased rapidly
during the past few years. They are employed as substitutes for
the more costly practices of hoeing, cultivating, mowing, chopping,
burning, and various other cultural practices for the control of
weeds. [p. 25]
One of the principal uses of the herbicide, 2,4,5-T, is for control
of weeds and brush on pasture and rangeland. Large quantities
are also used to control brush along roadways and under power-
lines. The principal crop use of 2,4,5-T is on hay and pasture.
In forest production, 2,4,5-T has proved useful for selective
weed control. 2,4,5-T acts upon deciduous hardwoods leaving the
conifers with little injury. This treatment has been helpful in re-
leasing conifers from deciduous hardwood competition in mixed
stands.
PRODUCTION
Total herbicide production in the United States has increased
rapidly:
"I960 75,000,000 pounds (S)
1965 220,000,000 pounds (8)
1968 403,000,000 pounds (12)
For 2,4,5-T (acid, esters and salts), production has increased
as follows:
1960 7,900,000 pounds (7)
1965 13,500,000 pounds (10)
1966 18,100,000 pounds (10)
1967 27,200,000 pounds (10)
1968 42,500,000 pounds (12)
A portion of this production is exported and a portion shipped
abroad for military use.
* Changes in the method of reporting after 1960 makes this figure difficult to compare with
later figures.
-------
1524 LEGAL COMPILATION—PESTICIDES
USES
1. Domestic.
a. Farm me.
In 1964, of the estimated 13,000,000 pounds of 2,4,5-T pro-
duced in the United States, only 13 percent or about 1,655,000
pounds were used in agriculture (Table 1). About 40 percent of
the quantity employed in agriculture was used for weed control
along fence rows, ditch banks, farm roadways, and other noncrop
uses. The remaining 60 percent or 979,000 pounds was employed
on crops (including hay, pasture and rangeland).
Since 1964, the use on farms has been decreasing. In 1966,
760,000 pounds were applied which is less than 50% of the 1964
amount (13). Use on hay, pasture, and rangeland declined 35 per-
cent, and other crop use decreased by 31 percent, whereas non-
crop use decreased about 84 percent.
b. Forestry, Rights-of-way, Aquatic Weeds and. Lawn and Turf.
In 1964, about 888,000 pounds of 2,4,5-T were used in private
nonfarm forest management for control of undesirable trees and
brush (Table 1); in 1966, this declined to 408,000 pounds
(Table 3).
TABLE l.-ESTIMATED USE OF 2,4,5-T IN THE UNITED STATES, 1964 (13)
Quantities of Proportion of
Use category Land treated active total quantity
per 1,000 acres 2,4,5-T applied applied
per 1,000 pounds (Percent)
Farm use:1
Hay, pasture and rangeland
Other farm use. ..
Total farm use ..
Non-farm use:
Federal Government agencies1 . __ . ..
Lawn and turf treatment4
Rights-of-waysB
Private non-farm forests'..
Other uses1 _
Total non-farm use - -
All uses. ,- .. . _ ,.
2441
. . ' 1,010
.. . 3,451
.. .- 296
1200
2175
430
81
306
4,488
7,939
581
1,074
1,655
656
600
4368
888
162
583
7257
•8912
'
7
12
19
7
7
49
10
2
6
81
100
1 Based on "Quantities of Pesticides Used by Farmers in 1964," AER 131. Farm data excludes Alaska and Hawaii.
In some farm uses, all acres in a field were reported treated while only spots actually received 2,4,5-T, thus making the
rate per acre seem low. '
' Sum of the acres of all crops, except hay, pasture, and rangeland treated, plus an acreage estimate for noncropland
receiving treatment. The acreage of noncropland was estimated by allocating the quantity of 2,4,5-T used for such
purposes at the rate of 2 pounds per acre.
3 Based on 1969 usage of the Departments of Agriculture, Interior, and Defense; and 1951-69 average usage by the
Tennessee Valley Authority.
* Based on estimated 500,000 acres of turf and 700,000 acres of lawns treated. Estimates based on "Extent and Cost
of Weed Control with Herbicides and an Evaluation of Important Weeds," ARS 34-102; and unpublished data.
' Based on sources cited in footnote 4 with rate of application same as for federally treated rights-of-way. Does not
include rights-of-way treated by Federal agencies.
• Estimated at 4 times the acreage treated and quantities of pesticides applied to public forests.
' Based on sources cited in footnote 4 and rates used on federally treated waterways.
• Includes governments other than federal and any other usage.
• Based on table 28 of the Pesticide Review 1969, Ag. Cons. Stab. Service.
-------
GUIDELINES AND REPORTS 1525
An estimated 4,368,000 pounds were applied to rights-of-way,
roadways, fire lanes, and similar areas for tree and brush control in
[p. 26]
1964 (Table 1); in 1966, this had decreased to 2,315,000 pounds
(TableS).
About 162,000 pounds were applied to aquatic habitats in 1964
for weed control on about 81,000 acres (Table 1) ; in 1966, this had
dropped to 75,000 pounds (Table 3).
TABLE 2.—FARM USE OF 2,4,5-T ON CROPS, BY CATEGORY OF USE, UNITED STATES, 1964 AND 1966 (13)'
Percentage
Active mgre- Acres treated of planted
dients per per 1,000 acres acres treated
Use category 1,000 pounds with 2,4,5-T
(percent)
Wheat
Other grams
All crop usage
1964 '
581
72
16
5
(')
' ; 264
41
_ .... 979
1966 5
379
58
26
6
23
34
127
653
1964'
2441
255
55
48
(')
1%
117
3,112
1966 >
861
337
59
18
16
99
175
1,565
1964*
0.4
0.4
(')
'HI
(')
1)4
0.1
0.3
1966s
0.1
0.5
0.1
0.1
0.8
0.2
0.2
0.2
1 Does not include Alaska and Hawaii. Use in 1964 generally reflects current practices. Use in 1966 was unusually small
and not representative of current practices because of domestic shortages due to increased military purchases.
* Revised estimates based on Quantities of Pesticides Used by Farmers in 1964. U.S. Dept. Agr., Agr. Econ. Rpt.
No. 131, Jan. 1968.
3 Data from the ERS Pesticide and General Farm Survey, 1966.
4 Acres treated as a percent of acres grown as reported in Stat. Bui. 384 and Agricultural Statistics 1968.
' Acres treated as a percent of acres grown as reported in Crop Production, 1967. U.S. Dept. Agr., Cr. Pr. 2-2(7-67).
' Less than one-tenth percent.
1 Included m other grains in 1964 only.
[p. 27]
TABLE 3.—QUANTITIES OF 2,4,5-T USED AND PERCENTAGE CHANGE IN USE, UNITED STATES, 1964 AND 1966 (13)
Use category
Farm use:1
Hay pasture, and rangeland ,.
Nonfarm use.
Federal Government agencies
Rights-of-way
Other uses _ -
All uses' .
Quantities of active Ri
2,4,5-T applied per (re
1,000 pounds i
1964'
581
1074
1 655
656
600
4,368
888
. 162
583
7257
8,912
1966 >
'379
>381
'760
»450
«300
•2,315
•408
'75
•292
3,840
•4,600
iduction
>m 1964
isage in
percent
35
65
54
31
50
47
54
46
50
48
48
'See table 1.
1 Data from 1966 ERS Pesticide and General Farm Survey, U.S. Dept. of Agric.
1 Based on decreases in Forest Service spending on timber improvement, and cooperative programs with states.
* Assuming 50 percent shift to dicamba.
• Residual after providing for other requirements.
' Based on same rate of reduction as total farm use.
' Based on same rate of reduction in 2,4,5-T use on hay, pasture, and rangeland.
• Assuming 50 percent of the 1964 use of 2,4,5-T was retained.
' Based on tables 2 and 3.
-------
1526 LEGAL COMPILATION—PESTICIDES
About 600,000 pounds of 2,4,5-T were applied to lawns and turf
in 1964 (Table 1) ; in 1966 this had fallen to 300,000 pounds
(TableS).
c. Fruit.
Small quantities (less than 10,000 pounds) of 2,4,5-T were used
as a growth regulator to thin fruit in the spring- and hold it on the
tree until harvest in the fall (9).
d. Federal Agencies.
The DOD, USDI, and USDA are the chief Federal agencies that
use 2,4,5-T on the lands they manage. During 1964 in continental
United States the Federal agencies used a total 656,000 pounds
(Table 1).
In 1969 the DOD treated 162,000 acres with 221,000 pounds of
2,4,5-T in continental United States (16). The majority of that
used by the Department of Defense was by the U.S. Army Corps
of Engineers Civil Works Program for the control of aquatic weeds
in navigable waters, in and around reservoirs, on stream banks
and rights-of-way. The use of herbicides on DOD installations is
generally restricted to small areas such as training sites, lawns,
fringes of air fields, fence rows and ammunition storage areas.
During 1969, the USDI treated 52,900 acres of rangeland with
38,200 pounds of 2,4,5-T; in addition 2,200 acres of aquatic habi-
tats were treated with 5,600 pounds (17).
In 1969, the USDA treated 107,000 acres of timberland with
221,000 pounds of 2,4,5-T. In addition, 34,000 acres of rangeland and
[p. 28]
2,000 acres of rights-of-way were treated with 94,000 pounds
(unpublished figures).
e. Economic Importance.
It is estimated that herbicides contribute significantly to the
profits of agriculture. For example, if phenoxy herbicides (includ-
ing 2,4,5-T) were not available, the net loss to rice producers in
the United States has been estimated at $7.6 million per year. This
represents some 2% of the farm value of all of the rice produced
in the United States per year or about 25% of the value of produc-
tion from acres treated with phenoxy herbicides (13).
2,4,5-T has a major use for control of brush under transmission
lines. It is estimated (13) that the control of brush with 2,4,5-T
on rights-of-way costs about $6.50/acre. Other chemicals which
could be substituted for 2,4,5-T on most of this acreage would
cost $42/acre. Manual control costs about $44/acre.
-------
GUIDELINES AND REPORTS 1527
The loss to agriculture if 2,4,5-T were no longer available would
be about $32 million (based on normal use in 1964 (see Table 4)).
Because of military demands for 2,4,5-T in Vietnam, the quantity
used in agriculture has declined by about one-half (Table 3).
It has been estimated that the increased costs of alternatives for
2,4,5-T for nonfarm use were about $20 million for 1964 (Table 4).
Between 1964 and 1966 these uses were also cut in half (Table 3).
If 2,4,5-T were not available and other phenoxy herbicides could
not be used as alternatives, it is estimated that the domestic cost
would be approximately $172 million (about $44 million for farm
use and $128 million for nonfarm use (Table 5)).
f. Registered Uses.
The registered uses of 2,4,5-T are shown in Table-6 for food-crop
use and in Table 7 for non-food crop use (14). r
L
TABLE 4.—ECONOMIC EFFECTS OF BANNING 2,4,5-T, IF OTHER PHENOXY HERBICIDES AND ALL OTHER
REGISTERED HERBICIDES COULD HAVE BEEN USED, UNITED STATES, 1970 (13)
Use category
Farm use:
Hay, pasture, rangeland1
Other farm use4
Total farm use -
Nonfarm use:
Federal Government5 - .
Lawn and turf*
Rights-of-way71 _
Private nonfarm forests' •
Aquatic areas710 .
Other"
Total nonfarm use ..
Total all uses
Esti-
mated
acres
treated
with
2,4,5-T'
1,000
acres
2,441
1010
3,451
296
1200
2,175
430
81
306
4,488
7939
Acres
that
could be
treated
with
alterna-
tive
1,000
acres
488
879
1,367
281
1,200
1,958
387
72
291
4,190
5,557
Acres
requir-
ing
addi-
tional
cultural
prac-
tices
1,000
acres
1,953
774
2,727
15
60
217
43
8
15
358
3,085
Cost of
2,4,5-T
and
appli-
cation
1,000
dollars
4,052
3,968
8,020
3,287
2,850
33,772
3,738
608
2,219
46,474
54,494
Cost of
alter-
native
herbi-
cides
and
appli-
cation
1,000
dollars
1,781
3,245
5,026
3,765
3,720
36,028
4,411
760
3,026
51,710
56,736
Cost of
addi-
tional
cultural
prac-
tices
1,000
dollars
32,443
2486
34,929
735
240
9,548
3,363
240
375
14,501
49,430
Net in-
creased
cost of
using
alter-
native1
1,000
dollars
30,172
1,763
31,935
1,213
1,110
11,804
4,036
392
1,182
19,737
51,672
1 From Table 1.
* Cost of alternative herbicides and application plus cost of additional cultural practices less cost of 2,4,5-T and
application.
1 The alternative herbicide was 0.5 Ibs. silvex and 1 Ib. 2,4-D on 20% of the acres treated. Cultural treatments on the
other 1,953,000 acres include renovating a third of the acres at $15.66 an acre; then bulldozing 72% of the remaining
two-thirds at $23.16 an acre, and mowing the other 28% at $1.50 an acre.
4 Most acres of individual crops treated with 2,4,5-T in 1964 could have been treated with 2,4-D. Silvex was applied
with 2,4-D on the noncropland. Rates of 2,4-D use on crops were assumed to be the 1966 average rate of all phenoxy
usage for that crop except tor other grains where 2,4-D was used at the same rate as 2,4,5-T. Supplemental hand or
mechanical control was used on some of the corn, sorghum, and noncropland. Additional acres of wheat, other small
grains, and other crops were grown to maintain production in spite of yield losses. In rice production, additional fertilizer
and a change in the crop rotation were required to maintain production and offset loss in quality.
1 Based on 1969 use by the Departments of Agriculture, Interior, and Defense; and TV A. Two Ibs. each of 2,4-D and
silvex were substituted for 2,4,5-T on 95;% of all acres treated in 1964. Remaining acres required additional cultural,
mechanical, and manual controls averaging $49.00 per treated acre.
4 All acres could have been treated with 0.5 Ibs. f '"
....... j. each of 2,4-D and silvex, but $4.00 of manual work was also required
on 5% of all acres.
1 Two Ibs. each of 2,4-D and silvex were used as substitutes for 2,4,5-T on 90% of all acres.
1 Ten percent of the acres required hand cutting at $44.00 per acre.
' Ten percent of the acres were mowed, hand cut, or undesirable species girdled at a cost of $78.21 per acre.
10 The remainder required cleaning with a drag line at $30.00 per acre for treated acres.
11 Two pounds each of 2,4-D and silvex were used to replace 2,4,5-T on 95% of these acres. The remaining acres required
mechanical control by hand or with machines at $25.00 per acre on which used. |~p 30]
-------
1528
LEGAL COMPILATION—PESTICIDES
TABLE 5.—ECONOMIC EFFECTS OF BANNING 2,4,5-T IF NO OTHER PHENOXY HERBICIDES COULD HAVE BEEN
USED BUT ALL OTHER REGISTERED HERBICIDES COULD HAVE BEEN USED, UNITED STATES, 1970 (13)
Use category
Farm use:
Hay, pasture, and rangeland*
Other farm use4
Total farm use
Nonfarm use:
Federal Government5
Lawn and turf8 „_
Rights-of-way7
Private nonfarm forests8
Aquatic areas0
Other" . ...
Total nonfarm use
Total all uses
Esti-
mated
acres
treated
with
2,4,5-T'
1,000
acres
2,441
1,010
3,451
296
1,200
2 175
430
81
306
4,488
7939
Acres
that
could be
treated
with
alterna-
tive
1,000
acres
628
628
83
1,200
1631
2,914
3542
Acres
requir-
ing
addi-
tional
cultural
prac-
tices
1,000
acres
2,441
618
3059
213
1,200
544
430
81
306
2774
5833
Cost of
2,4,5-T
and
appli-
cation
1,000
dollars
4,052 _
3,968
8,020
3,287
2,850
33772
3738
608
2,219
46,474
54494
Cost of
alter-
native
herbi-
cides
and
appli-
cation
1,000
dollars
6,386
6,386
3,901
2,310
84812
91,023
97,409
Cost of
addi-
tional
cultural
prac-
tices
1,000
dollars
40,551
5 167
45718
10,863
4,800
23936
33630
2,430
7,650
83,309
129 027
Net in-
creased
cost of
using
alter-
native'
1,000
dollars
36,499
7,585
44,084
11,477
4,260
74976
29892
1,822
5,431
127,858
171,942
1 From Table 1.
2 Cost of alternative herbicides and application plus cost of other treatments less cost of 2,4,5-T and application.
1 Cultural treatments include renovating a third of the acres at $15.66 an acre; then bulldozing 72% of the remaining
two-thirds at $23.16 an acre, and mowing the other 2B% at $1.50 an acre.
4 Weeds on some acres of most crops treated with 2,4,5-T in 1964 could have been controlled with nonphenoxy herbi-
cides. Important chemical substitutes used include dicamba, atrazine and oil on crops and picloram on noncropland.
Supplemental hand or mechanical control was also required on some corn, sorghum, small grains, and noncropland.
Additional acres of wheat, other small grams, and other crops were grown to maintain production in spite of yield losses.
In rice production additional fertilizer and a change in the crop rotation were required to maintain production and offset
loss in quality.
' Based on 1969 use by the Departments of Agriculture, Interior, and Defense; and TVA. Two pounds of picloram
with a drift reducing adjuvant were substituted for 2,4,5-T on 75 percent of federally maintained rights-of-way. All
other acres required cultural, mechanical, and manual control averaging $51.00 per acre.
• All acres can be treated with 0.5 pound dicamba but supplemental manual work costing $4.00 per acre was required
on all acres.
' Two pounds of picloram with a drift reducing adjuvant were substituted for 2,4,5-T on 75 percent of all acres. The
remainder required hand cutting at $44.00 an acre.
' All acres had to be mowed, hand cut, or undesirable species hand girdled at a cost of $78.21 per treated acre.
' All acres needed to be mechanically cleaned with a drag line at $30.00 per acre treated.
11 All acres required mechanical control by hand or with machines at $25.00 per acre.
[p.31]
-------
GUIDELINES AND REPORTS 1529
USDA SUMMARY OF REGISTERED AGRICULTURAL PESTICIDE CHEMICAL USES 2,4,5-TRICHLOROPHENOXYACETIC
ACID
(Principal formulations. EC esters; amine salts; Type pesticide: Herbicide and plant regulator)
Tolerance
Use (ppm) Dosage Limitations
Ib. actual/A.
Pastures: Grasses Extended... 3 Heavy brush. Apply when in full leaf and after grass is well
established.
1 Light brush. Apply when leaves are fully expanded.
Rangeland clearance Extended.__ 4 Apply in spring by airplane when brush is in heavy foliage
stage (40-90 days after leaves unfold).
Apples (Mclntosh) Extended 20 ppm spray (acid Preharvest drop control. Apply a single application 4-5 days
equivalent). before drop normally begins.
Blueberries (low bush).. Extended... 1.0 (acid Spray on revolving cloth-covered drum held above blueberry
equivalent). foliage. Apply during June and July of season preceding
a burn. Do not apply within 2 years of harvesting berries.
Grains, cereal Extended... 0.5 Apply when gram is in tiller to boot stage and weeds are in
(undesignated). actively growing condition. Do not apply from boot to
milk stage or in seedling stage.
Pastures: Grasses Extended... 3 Heavy brush. Apply when in full leaf and after grass is well
established.
1 Light brush. Apply when leaves are fully expanded.
Rangeland clearance Extended... 4 Apply in spring by airplane when brush is in heavy foliage
stage (40-90 days after leaves unfold).
Rice Extended... 1.25 Apply tiller to boot and before flooding (4-8 weeks after rice
emerges).
1.5 Apply after flooding (2-3 weeks) or 7-10 weeks after
planting.
Sugarcane Extended.__ 1 Preemergence use only (Louisiana). If cane is shaved and
off-barred, treat immediately following this operation.
4.5 Preemergence use only (Hawaii). Apply just before cane
emerges.
1 Postemergence (weeds in established cane). Apply over row
when weeds are growing vigorously. Do not apply after
cane is 2 feet tall.
Lakes; Ponds... Extended... 4 (with 20 Ibs./A. Broadcast application in early spring to summer. Do not use
2,4-D as ester). treated water for crop irrigation or livestock drinking water.
TABLE 7.—THE NONFOOD CROP USES OF 2,4,5-T. THE DOSES LISTED BELOW ARE GIVEN IN POUNDS OF 2,4,5-T
AND EQUIVALENT IN 100 GALLONS OF SPRAY USING WATER OR OIL AS THE VEHICLE. (USDA, PESTICIDE REG-
ULATION DIVISION, AS AMENDED BY PESTICIDE REGULATION DIVISION NOTICES 70-11 (4/20/70) AND 70-13
(5/1/70).
Pounds
Non-food crop uses 2,4,5-T acid Comment
Farm fence rows, lanes and roads ..
Pine release in hardwood forest
Industrial buildings including: Around factories, elevators, loading platforms, oil refineries, etc.
Industrial sites: Airline beacon stations, airport runways, coalyards, electric transformer
stations, lumberyards, parking areas, radio towers, railroad sidings, sawmills.
Recreational areas including* Race tracks, wildlife management
Rights-of-way: Fire lanes, highways, pipelines, powerlmes, railroads, telephone and telegraph .
Vacant lots
2
2-6
2-6
12-16
3-12
5.6-10
4-20
2-4
2. Military Uses of 2,4,5-T.
The phrase, military uses, refers to the employment of 2,4,5-T
as a defoliant in operations. Basic research on herbicides proceeded
through the period 1941-1947. The work was encouraged by efforts
[p.32]
to develop defoliating agents for use in jungle areas of the South
Pacific area during World War II (2). A major demonstration of
the utility of the mixture now known as Orange (1:1 mixture of
the butyl esters of 2,4-D and 2,4,5-T) as a defoliant for military
purposes was conducted in 1959 (1).
-------
1530 LEGAL COMPILATION—PESTICIDES
A preliminary series of defoliation trials was conducted in Viet-
nam between July 1961 and April 1962 (S). Operational spraying
began in Vietnam in 1962 and increased sharply after 1967. Re-
views on this subject are available (3, 5, 6).
Two herbicide formulations used in military operations in South-
east Asia include 2,4,5-T:
Agent
Purple
Orange
Composition
n-butyl ester 2 4-D 50% (wt )
n-butyl ester 2,4,5-T 30% (wt.).
Isobutyl ester 2,4,5-T 20% (wt.).
n-butyl ester 2 4-D 50% (wt )
n-butyl ester 2,4,5-T 50% (wt.).
Lb./Gal.
of active
material
89
89
Purple mixture was discarded early because it was found to be
no more effective than Orange. Orange is applied at a rate of 24 Ib.
per acre from both fixed wing aircraft and helicopters. C-123 air-
craft fly at 150 feet altitude at 130 knots. A swath of 240 feet per
pass is sprayed. Typically, a formation of 3-9 aircraft fly at the
same time.
The following table shows the total areas sprayed each year
between 1962 and 1968.
TABLE 8.-LAND AREA IN VIETNAM TO WHICH DEFOLIANTS HAVE BEEN APPLIED BETWEEN 1962 AND 1968 (15)
Year Number of acres sprayed
1962 4,940
1963 24,700
1964 _ 83,486
1965 ._ 155,610
1966 _ 741,247
1967 _ _. 1,486,446
1968 _ _. 1,267,110
It has been estimated that under usual operating conditions 90%
of the released material is confined to a band about 2.0 km wide on
either side of the 80 meter spray path (15). This figure is based
on the spectrum of particle sizes, the direction and speed of the
crosswind, and the altitude. Under realistic conditions but with a
crosswind at right angles to the flight path, only 0.1% of the spray
would be deposited between 1 and 2 km from the center line of
the flight path.
As shown in Table 8, the total area sprayed for defoliation in
1968 was less than in 1967. Defoliation was discontinued in April
197°- r~ *
-------
GUIDELINES AND REPORTS 1531
These three areas comprise about one-fifth of the total area to
which defoliants have been applied.
The Rung Sat Special Zone is an area which surrounds the ship-
ping channel into Saigon. 113,600 acres had been sprayed by the
end of January 1968 (6). War Zone C is northwest of Saigon be-
tween the Song Be River and the Cambodian border. 227,000 acres
had been treated in War Zone C by January 1968. War Zone D,
in which 405,000 acres were treated, is northeast of Saigon be-
tween the Song Be and Song Dong Hai Rivers (6). Repeated appli-
cation was made in some areas.
The general purposes for which defoliation operations have been
used include:
a. Defoliation of lines of communication. Sites of frequent am-
bush have been defoliated to afford better visibility along roads
and trails.
b. Defoliation of areas where Vietcong tax collectors customarily
exacted payments from the populace.
c. Defoliation of enemy infiltration routes.
d. Defoliation of enemy base camps. The rationale in this case
was based on the observation that the enemy tended to move out
of a base after the area had been sprayed.
e. Clearing of vegetation around American base camps and fire
bases in order to clear fields of fire and improve observation.
Importance of 2,4,5-T as a military defoliating agent.
Systematic studies have not been carried out to quantify the value
of defoliation in Vietnam. However, many of those concerned with
the program believe that the military advantages are clearly evi-
dent (4, 15). The following evaluations are extracted from testi-
mony offered by Rear Admiral W. E. Lemos before the Subcommit-
tee on National Security Policy and Scientific Developments of
the Committee on Foreign Affairs (4).
a. Major defoliation has been accomplished in War Zone C. Prior
to defoliation, 7 brigades were necessary to maintain US/GVN
presence. After defoliation, only 3 brigades were required.
b. The Commander of Naval Forces in Vietnam in a report to
General Abrams stated: "As you know, a major concern is the
vegetation along the main shipping channel. Your continuing ef-
forts under difficult and hazardous flying conditions, in keeping
this area and the adjacent inland areas devoid of vegetation have
contributed considerably in denying the protective cover from
which to ambush the slow-moving merchant ships and U.S. Navy
craft."
-------
1532 LEGAL COMPILATION—PESTICIDES
c. In 1968, the Commanding General of the First Field Force re-
ported : "Defoliation has been effective in enhancing the success of
[p. 34]
allied combat operations. Herbicide operations using C-123
aircraft, helicopters, truck mounted and hand sprayers have be-
come an integral part of the II CTZ operations against VC/NVA.
The operations are normally limited to areas under VC/NVA con-
trol remote from population centers. The defoliation program has
resulted in the reduction of enemy concealment and permitted in-
creased use of supply routes by friendly units. Aerial surveillance
of enemy areas has improved and less security forces are required
to control areas of responsibility. An overall result of the herbi-
cide program has been to increase friendly security and to assist
in returning civilians to GVN control."
d. The U.S. Commander in the III CTZ related: "Herbicide
operations have contributed significantly to allied combat opera-
tions in the III Corps. Defoliation is an important adjunct to target
acquisition. Aerial photographs can often be taken from which
interpreters can "see the ground" in areas that previously were
obscured. Defoliation also aids visual reconnaissance. USAF FAC's
(forward air controllers) and U.S. Army aerial observers have
discovered entire VC base camps in defoliated areas that had pre-
viously been overlooked."
e. In the south in the IV CTZ, C-123 herbicide operations are
limited. This is because of the vast areas of valuable crops which
are not to be destroyed, even though they may be in enemy hands.
Therefore, commander of the IV Corps area in presenting his eval-
uation cited the value of helicopter operations as follows: "A sig-
nificant helicopter defoliation mission was conducted in the vicin-
ity of SADEC in August 1968. The target area consisted of 3 main
canals which converged and formed a strong VC base. The dense
vegetation permitted visibility of only 10-15 meters horizontally
and nil vertically. The area was sprayed with approximately 135
gallons of herbicide White and over 90 percent of the area was
defoliated. As the result of the defoliation, an ARVIN battalion
was able to remain overnight in the area for the first time in five
years. Many enemy bunkers were open to observation. Since the
defoliation, the VC presence has decreased to the point that only
RF/PF forces are now necessary for local security."
f. As a part of the 1968 evaluation report of herbicide opera-
tions, the U.S. Senior Advisor in the IV Corps Tactical Zone area
reported: "A section of National Highway 4 in Phong Dinh Prov-
ince was the site for a defoliation operation on 24 June 1968. Since
-------
GUIDELINES AND REPORTS 1533
January 1968, a series of ambushes was conducted against SYN
convoys and troop movements. Because of the total inability of
ground troops to keep the area clear of VC, this area was sprayed
using 685 gallons of herbicide White. The target area was primar-
ily coconut palm and banana trees that had been abandoned by their
owners for several years. During the period of abandonment the
vegetation had become so dense that convoy security elements were
not able to see more then five meters into the underbrush and had
to rely on reconnaissance by
r
Lp.
fire to discover the hidden enemy. This method of protection had
proven ineffective. Three RF/PF companies with U.S. advisors
were used to secure the target for the helicopter operation in
addition to an armord cavalry troop. Since the defoliation mission
was completed, convoys have used the highway 2 or 3 times a
week without attack or harassment. Only one RF platoon has
remained in the area to provide local security to the hamlet and
highway."
g. In certain instances, we know the VC have been forced to di-
vert tactical units from combat missions to food-procurement oper-
ations and food transportation tasks, attesting to the effectiveness
of the crop destruction program. In local areas where extensive
crop destruction missions were conducted, VC/NVA defections to
GVN increased as a result of low morale resulting principally from
food shortages.
The most highly valued item of equipment to field commanders
in Vietnam is the helicopter. There was some question when the
helicopter spray equipment was first procured whether field com-
manders would divert the use of helicopters from combat opera-
tions for herbicide spray operations. The very fact that the com-
manders have used their helicopter spray equipment to the fullest
and have asked for more is certainly proof that herbicide opera-
tions have been helpful in protecting the American Soldier and
contributing to successful accomplishment of the ground combat
mission." (4)
COST SHARING PROGRAMS
The Agricultural Stabilization and Conservation Service of the
U.S. Department of Agriculture has provided a cost sharing pro-
gram for farmers in order to encourage desirable farm and con-
servation practices. Included in this Agricultural Conservation
Program are two programs in which 2,4,5-T was used :
1. Control of competitive shrubs on range and pastures.
In 1968, $7 million were paid to farmers who treated 1.9 million
-------
1534 LEGAL COMPILATION—PESTICIDES
acres. Approximately one-half of this land was treated with chem-
icals, a substantial part of which was 2,4,5-T. The remainder was
treated by mechanical means.
2. Control of specified noxious weeds on farmland or biennial
weeds on pasture and range lands.
In 1968, $1.75 million were paid to farmers to treat 700,000 acres.
In some cases 2,4,5-T was used, although in most cases, 2,4-D
and other chemicals were employed.
REFERENCES
(1) BROWN, J. W. Vegetation Control, Camp Drum. U.S. Army Biological
Laboratories, Crops Division, Frederick, Md. Summary Report, 1959.
(S) DELMORE, F. J. Importance of defoliation in counter emergency opera-
tions. Proc. First Defoliation Conference, July 29-30,1963. r ocn
LP. ooj
(S) HOUSE, W. B., GOODSON, L. H., GADBERRY, H. M., and DOCKTER, K. W.
Assessment of ecological effects of extensive or repeated use of herbi-
cides. Midwest Research Institute, Proj. No. 3103-B, December 1967.
(4) LEMOS, W. E. Testimony before the Subcommittee on National Security
Policy and Scientific Development, Committee on Foreign Affairs,
House of Representatives, December 15,1969.
(5) PETERSON, G. E. The discovery and development of 2,4-D. Agricultural
History, Vol. XIL(3), 11243-259, U.S. Government Printing Office,
1967.
(6) TSCHIRLEY, F. H. Science 163:779,1967.
(7) U.S. Department of Agriculture. The Pesticide Situation for 1962-
1963. USDA, Agricultural Stabilization and Conservation Service.
(8) U.S. Department of Agriculture. The Pesticide Review 1966. USDA,
Agricultural Stabilization and Conservation Service.
(9) U.S. Department of Agriculture. Quantities of Pesticides Used by
Farmers in 1964. USDA, Economic Research Service. Agricultural
Economic Report No. 131,1968.
(10) U.S. Department of Agriculture. The Pesticide Review 1968. USDA,
Agricultural Stabilization and Conservation Service.
(11) U.S. Department of Agriculture. Quantities of Pesticides Used by
Farmers in 1966. USDA, Economic Research Service Agricultural
Economic Report, 1969.
(IS) U.S. Department of Agriculture. The Pesticide Review 1969. USDA,
Agricultural Stabilization and Conservation Service.
(IS) U.S. Department of Agriculture. Report and tables on domestic use of
2,4,5-T, 1964 and 1966, supplied by Production Resources Branch,
Farm Production Economics Division, July 1970.
(14) U.S. Department of Agriculture. Information and tables on registered
uses of 2,4,5-T, supplied by Pesticides Regulation Division, Agricul-
tural Research Service.
(IS) U.S. Department of Defense. Material supplied by Department of De-
fense Research and Engineering, November 1969.
(16) U.S. Department of Defense. Unpublished report.
(17) U.S. Department of the Interior. Table on herbicide use by USDI.
Supplied by U.S. Department of the Interior, 1969. [p. 37]
-------
GUIDELINES AND REPORTS 1535
TOXICOLOGY
SUMMARY
Relatively little toxicological information has been available
on 2,4,5-T. Most of the experiments prior to the National Cancer
Institute screening study were of acute, single-dose or short-term
toxicity. The longest period of observation was 90 days. It was as-
,sumed (not unreasonably) that the several phenoxy herbicides be-
haved in similar fashion toxicologically. Hence, an understanding
of aspects of the toxicology of 2,4,5-T was inferred from experi-
ments with 2,4-D. The sample sizes used in many of the early tox-
icity studies were so small that it is difficult to draw statistically
valid inferences. The studies indicated that 2,4,5-T is only mod-
erately toxic. Relatively little is known about the mechanisms of
toxicity of 2,4,5-T or of its metabolism in man and animals.
The screening study of pesticides carried out under contract for
the National Cancer Institute tested the teratogenicity of a number
of compounds, including 2,4,5-T. 2,4,5-T appeared to be terato-
genic in mice and rats. Subsequent studies have confirmed these
observations and in addition indicated that purified 2,4,5-T con-
taining less than 1 ppm of the toxic contaminant tetrachlorodi-
benz-p-dioxin as well as 2,4,5-T contaminated with 27 ppm dioxin
are teratogenic. It has also been reported that dioxin by itself is
teratogenic. Tumor production by 2,4,5-T was not found.
Accounts of birth defects in defoliated areas of Vietnam have
been reported. The information available does not permit the con-
clusion that 2,4,5-T used in Vietnam has been the cause of human
birth defects.
2,4,5-T is classed as a plant hormone since, in appropriate
amounts, it accelerates plant growth. The mechanism of the herbi-
cidal effect is not fully understood. However, it is generally be-
lieved that excess growth stimulation and herbicidal properties
are related. Herbicidal effects occur when these materials are
used in large doses.
LP- a°J
A. ACUTE TOXICOLOGICAL INVESTIGATIONS
Toxicological studies on 2,4-D were first reported in 1944 (8).
However, there were no published reports of toxicological inves-
tigations of 2,4,5-T until 1953. In that year, Drill and Hiratzka
(5) reported a series of studies of acute and subacute toxicity of
2,4,5-T on dogs. The material used was commercially available
2,4,5-T (presumably the acid) and was administered in capsules
mixed in dog food. The single acute dose ranged from 50-400
-------
1536 LEGAL COMPILATION—PESTICIDES
mg/kg/. Chronic toxicity was studied in this case by oral adminis-
tration in doses of 2-20 mg/kg/day, 5 days per week over a period
of 13 weeks. Observations and measurements made included deter-
mination of the number of days until death ensued, changes in
body weight, general observations of abnormal physical signs,
gross pathology of organs, and selected histology. The number of
animals used was small (as few as one per dose and as many as
four per dose). In brief, the findings of this study suggested that a
single fatal dose for dogs lay somewhere between 100 and 400
mg/kg. It was inferred by the author that the acute LD50* was
around 100 mg/kg for dogs. Repeated daily doses of 20 mg/kg
led to the death of all four animals tested within 11-75 days. Re-
peated daily doses of 10 mg/kg did not prove fatal over a 90-day
period. There were some overt signs of toxicity including weight
loss, stiffness of hind legs, muscular weakness and, occasionally,
bleeding from gums.
The Dow Chemical Company, a manufacturer of 2,4,5-T, under-
took a series of studies of acute toxicity of this material beginning
around 1950. This series included a variety of species of animals
and a number of the various salts and esters of 2,4,5-T and sev-
eral of the various formulations. The details of these studies have
never been published in the open literature. A number of them have
been submitted as background material for a petition for the grant-
ing of a tolerance for the herbicide for uses of food crops. In 1954,
a summary of some of this work was published by Rowe and Hymas
(17). Table 1 lists the various herbicidal agents tested.
Table 1. Herbicidal formulations. &?• 391
TABLE 1.—HERBICIDAL FORMULATIONS STUDIED BY ROWE AND HYMAS (17)
Trade name Active ingredients (percent)
2,4-Dowweed killer (formula 40) 65.0 Alkanolamme salts of 2,4-D
Esteron44 44.0 Isopropyl ester of 2,4-D
Esteron 245 (old formulation).. 33.3 Isopropyl ester of 2,4,5-T: 12.1 mixed amyl esters of
2,4,5-T
Esteron 245 (present formulation),. 65.3 Mono-, di-, tnpropylene glycol butyl ether esters of
2,4,5-T
Esteron ten-ten 70.5 Mono-, di-, tripropylene glycol butyl ether esters of 2,4-D
Brush killer 50-50. 27.2 Butyl esters of 2,4-D; 26.5 Butyl esters of 2,4,5-T
Brush killer T 52.2 Butyl esters of 2,4,5-T
Esteron 76 (used in oil solution only) 37.1 Isopropyl esters of 2,4-D; 39.0 n-Butyl ester of 2,4-D
Esteron 76E (used in either oil solution or water emulsion). 36.8 Isopropyl esters of 2,4-D; 38.8 Butyl esters of 2,4-D
Esteron brush killer (old formulation) _ 25.6 Isopropyl esters of 2,4-D; 24.4 Isopropyl esters of 2,4,5-T
' " " tripropylene glycol butyl ether esters or
tripropylene glycol butyl ether esters of
Kuron (was called H-1078) 64.5 Mono-, di-, tripropylene glycol butyl ether esters of silvex
Dow MCPamineweed killer* 69.1 Alkanolamme salts of MCP
•2-methyl-4-chlorophenoxyaceticacid.
f 34.8 Mono-, di,, tr
Esteron brush killer (present formulation) < ,,?i*:P .. ..
1 33.0 Mono-, di-, tn
I 2,4,5-T
• LDgo—median lethal dose=the amount of a toxic agent which will be lethal to 50% of
the test animals to which it is administered under the conditions of the experiment.
-------
GUIDELINES AND REPORTS 1537
Table 2 presents a summary of the acute oral toxicities of the
various herbicide components.
TABLE 2.-ACUTE ORAL TOXICITIES OF VARIOUS PHENOXY ACETATE HERBICIDAL CHEMICALS. ROWE AND
HYMAS (17)
l.d. so (19/20 con-
Material Species Sex Vehicle fidence limits)
(mg./kg.)
24,5-T(2,4,5-Tnchlorophenoxyaceticacid) Rats M OliveoiL... 500(391-640)
Mice. M Oliveoil.-- 389(245-619)
Guinea pigs... M and F... Olive oil 381 (307-472)
Chicks MandF... Oliveoil—. 310(211-456)
Range
Dogs (4) Capsule... 100(50-250)
2,4,5-T, isopropyl ester _ Rats M and F... Oliveoil.... 495(420-584)
Guinea pigs... F Oliveoil 449(362-557)
Mice F Olive oil.... 551 (380-799)
2,4,5-T, mixed butyl esters _. Rat F Corn oil.... 481(313-739)
Range
Rabbit _. M Corn oil.... 712(500-1,000)
Mice F.. Corn oil.... 940 (674-1,312)
Range
Guinea pigs... F Corn oil 750(500-1,000)
Range
2,4,5-T, mixed amyl esters ._ _ Rats F Oliveoil.... 750(500-1,000)
Range
MCP (4-chloro-o-toloxyacetic acid or 2-Metnyl-4- Rat M Corn oil.... 700(500-1,000)
chlorophenoxyacetic acid). Range
MCP, amme salt ._ _ Rat M Water 1,200(1,000-2,000)
Range
Guinea pigs... M Water 1,200(630-2,000)
silvex, (2[2,4,5-trichlorophenoxy] propionic acid) Rat... _. MandF... Corn oil 650(560-760)
Range
silvex, mixed butyl esters Rat F Corn oil 600(250-1,000)
Range
Rabbits F Undiluted.. 750 (500-1,000
Chicks MandF... Corn oil.... 1,190(707-2,000)
silvex, mono-, di-, tripropyleneglycol butyl ether esters. Rat F.._ _ Corn oil 621(473-814)
Range
Guinea pigs... M Corn oil 1,250(500-2,000)
Range
Mice. F Corn oil.... 1,410(1,000-2,000)
Chicks M and F— Corn oil . 1,190(847-1,670
Rabbits F... Undiluted.. 819(610-1,070)
[p. 40]
Similarly, Rowe and Hymas reported the results of oral feeding
of several commercial formulations of 2,4,5-T and related com-
pounds (TableS).
Rowe and Hymas concluded that the acute LD50 for 2,4-D,
2,4,5-T, and their various formulations and combinations fell in
the range of 300-1000 mg/kg. There was some variation among
species with dogs appearing relatively more sensitive than other
species of animals.
Military applications of 2,4,5-T as a defoliant have utilized
combinations of 2,4-D and 2,4,5-T in formulations known as
Orange and Purple. There has been some acute toxicological testing
of the mixture, Purple, on small animals. Purple contains 50 per
cent butyl ester of 2,4-D, 20 per cent isobutyl ester of 2,4,5-T and
30 per cent n-butyl ester of 2,4,5-T. The details of this work have
not been published but have appeared in summary form in a review.
(8) (Table 4) [p 41]
-------
1538
LEGAL COMPILATION—PESTICIDES
TABLE 3.-SUMMARY OF ORAL TOXICITIES OF A VARIETY OF PHENOXY ACETATE HERBICIDAL FORMULATIONS.
ROWE AND HYMAS (17)
Material
Species
Sex
Vehicle
l.d.5"
(19/20 confidence
limits)
(mg./kg.)
Rani
2,4-Dowweed killer Guinea pigs F Water 2,000 (1,000-3,000)
Range
2,4-Dowweed killer (formula 40) Rats __ F Water 850 (700-1,000)
Range
Esteron44 Rats M Olive oil 650(300-1,000)
Range
Esteron 245 (old) Rats F Emulsion in water.. 1,000(300-2,000)
Range
Esteron 245 (new) Rats M Olive oil 800(600-1,000)
Esteron ten-ten _ Rats F Oliveoil 760(660-860)
Brush killer 50-50 Rats F Emulsion in water.. 1,070(700-1650)
Guinea pigs F Emulsion in water.. 1,160(820-1,630)
Mice F Corn oil 800 (624-1,070)
Range
Rabbits F _.. Undiluted 1,420 500-2,000)
Chicks MandF Undiluted 4,000 2,700-5,000)
Brush killer T .._ Rat F Emulsion in water.. 1,200 783-1,850)
Guinea pigs F Emulsion in water.. 1,410 875-2,290)
Mice F Oliveoil 1,230 (938-1,620)
Rabbits M Undiluted 849(604-1,190)
Chicks M and F Undiluted 2,000 (1,350-2,960)
Range
Brush killer 76 Rats F _._ Corn oil 750 (500-1,000)
Range
Brush killer 76E — Rats F Corn oil 300 (250-1,000)
Range
Esteron brush killer (old) Rats. M Emulsion in water.. 1,000(300-3,000)
Esteron brush killer (new) Rats MandF Corn oil 860(800-930)
Guinea pigs M Corn oil 1,220 (1,040-1,430)
Guinea pigs F Corn oil 1,600 (1,390-1,840)
Rabbits MandF CornoiL... 960(790-1,160)
Range
Chicks M and F .. Corn oil 2,000 (1,000-3,000)
Steers •_ Undiluted Greater than 1,000
TABLE 4.—ACUTE ANIMAL TOXICITY OF PURPLE (8)
Route
Toxicity
Dosages (mg/kg)
Rat
Rabbit
Dog
Oral
Intraperihmeal..
Intratracheal...
Percutaneous...
LD".
LD»_.
IDs*
LD'__
.
LD>._
LD".
566 .
213 .
586
121
569 .
244 .
5,562
3,178
1,994
363
12,034 .
493
a 500
>250
a 500
>250
> 1,250
a=approximation
There have been a few accounts of testing for acute toxicity of
2,4,5-Ton domestic animals (14,17). These indicated that repeated
doses of 100 mg/kg of 2,4,5-T were tolerated without over signs
of illness in sheep and steers. In one instance 1000 mg/kg/day
proved fatal to a steer after the third day. 500 mg/kg/day pro-
voked signs of acute toxicity in steers after the third day (17).
The numbers of animals used in these studies were very small (sin-
gle animals in some cases).
It has been assumed by some that the metabolism (and, hence,
-------
GUIDELINES AND REPORTS 1539
toxicity) of 2,4,5-T would resemble that of the other phenoxy acid
herbicides. This is probably a reasonable assumption although it
has not been systematically examined. There have been two recent
reviews of the toxicity of phenoxy acid herbicides (3), (19). In-
cluded in these reviews are accounts of acute human toxicity of
2,4-D. The accounts include incidents of excessive occupational ex-
posure, suicidal efforts, intended oral feeding and parenteral ad-
ministration as a form of treatment for coccidioidomycosis. From
descriptions such as these, it has been inferred that around 50 to
100 mg/kg of 2,4-D is acutely toxic to humans. However, there are
inconsistencies in this scanty information.
OCCUPATIONAL EXPERIENCE
Occupational exposures (in the 2,4,5-T manufacturing process
have provoked illness in workers. However, these effects have been
attributed to the dioxin impurity (tetrachlorodibenz-p-dioxin).
(See Section III, Chemistry). The toxicity of this impurity is con-
sidered later in this section.
NATIONAL CANCER INSTITUTE SCREENING STUDY FOR
CARCINOGENESIS AND TERATOGENESIS
In 1964, the National Cancer Institute contracted for a screen-
ing study of a number of pesticides. Among the purposes of this
large scale examination was to determine whether compounds in
common use might be tumorigenic, or teratogenic or mutagenic
(12). The results of r
testing for carcinogenesis have been summarized by Innes et al.
(9). The results of testing for teratogenesis with 2,4,5-T have
been analyzed and summarized by Courtney et al. (2) .
Screening for tumorigenicity was performed on two hybrid
strains of mice. The materials, which were from commercial lots,
were given by single subcutaneous injection or by continuous oral
feeding. For each dose and each strain, 18 animals of each sex
were used. Oral feeding was started when the animals were seven
days old and was continued for 18 months. The dose chosen cor-
responded to a maximal tolerated dose. This was the experimen-
tally determined maximum level resulting in zero mortality for
19 daily doses. The dose of 2,4,5-T used in the oral feeding studies
was 21.5 mg/kg. Of the 72 mice which started the study, 12 died
or were cannibalized before the end of the 18 months. Of those
surviving, nine animals exhibited tumors. Of the total number
-------
1540 LEGAL COMPILATION—PESTICIDES
necropsied (survivors plus premature deaths), 12 animals ex-
hibited tumors. These included 4 reticulum cell sarcomas, 2 pul-
monary adenomas, 5 heptomas, and 1 benign calcifying epithe-
lioma.
These results were compared with the tumor incidence in a
group of untreated control animals and in a group of animals
treated with known tumorigens. 2,4,5-T was not found to provoke
a significant increase in tumors after chronic administration.
In addition to 2,4,5-T, several related phenoxy compounds were
also screened for tumor production. The compounds included:
2,4-D
2,4-D isopropyl ester
2,4-D butyl ester
2,4-D isooctyl ester
a-(2,4-dichlorophenoxy) propionic acid
a- (2,5-dichlorophenoxy) propionic acid
a-(2,4,5-trichlorophenoxy) propionic acid
Three of these compounds administered by the subcutaneous
route [a-(2>4-dichlorophenoxy) propionic acid; a-2,4,5-trichloro-
phenoxy) propionic acid; and 2,4-D isopropyl ester] elicited
an increase in tumor incidence in comparison with negative con-
trols but the statistical significance was less than 0.02.
Screening for teratogenic effects was performed on four strains
of mice and, in the case of 2,4,5-T, on one strain of rats. 2,4,5-T
was one of 53 compounds examined in this study. Other related
agents included were:
2,4-D
2,4-D isopropyl ester
2,4-D butyl ester
2,4-D isoctyl ester
2,4-D methyl ester
2,4-D ethyl ester
a-(2,5-dichlorophenoxy) propionic acid r .„,
2,4-dichlorophenol
2,4,5-trichlorophenol
2,4,6-trichlorophenol
Compounds were administered subcutaneously in solution of
dimethyl sulfoxide in maximally tolerated doses to pregnant
female animals. Administration occurred between the 6th and the
14th days of gestation in mice. The animals were sacrificed on the
18th day and the fetuses were examined for abnormalities. With
-------
GUIDELINES AND REPORTS 1541
the finding of apparent increase in birth defects, the experiments
were repeated with oral administration of the agents. Because of
the findings of an increase in birth defects in the case of 2,4,5-T,
this compound was studied more intensively (wider range of doses
and two species of animals).
Evaluation compared the influence of these chemicals on the
total incidence of birth defects. In addition, a further analysis
attempted to reduce the interlitter statistical influences by calcu-
lating the incidence of birth defects on a litter-by-litter basis (2).
2,4,5-T was tested in the C57BL/6 and AKR strains of mice,
and in a hybrid strain produced by mating C57BL/6 females with
AKR males. Three dosage levels (21.5, 46.4, and 113.0 mg/kg)
were used orally and by injection. Numbers of litters varied from
6 to 18 in the experimental animals (6 to 12 in the orally fed
animals). Three different patterns of dosage and sacrifice were
used (dosage during days 6-14, 6-15, and 9-17). The findings
from this set of experiments were increases in incidence of fetuses
with cleft palate and fetuses with cystic kidney when compared to
controls. There was also an indication of a dose-response rela-
tionship. Table 5, reproduced from Courtney et al. (2), summa-
rizes the findings. The numbers in the columns representing the
percentages of abnormal fetuses per litter were derived by aver-
aging the percentages of abnormalities per litter for each dosage.
Because of these results, an additional series of experiments
was conducted in Sprague-Dawley rats. Four dosage levels were
used (4.6, 10.0, and 21.5 and 46.4 mg/kg). Two types of fetal
abnormalities were recognized, cystic kidney and enlarged renal
pelvis. Courtney et al. (2), in reviewing these experiments, ana-
lyzed the results on the basis of abnormalities per litter. In reduc-
ing the sample size from the total number of fetuses to the total
number of litters, these authors felt that the resulting sample
size for the 21.5 mg/kg dosage was too small and, hence, deleted
the data for this dose. Table 6 is a summary of these data.
The inferences which have been drawn from these experiments
are that 2,4,5-T appears to provoke a higher than expected level
of fetal death and fetal abnormality in rats and mice in the dosages
used. Further, there appeared to be a suggestion of a dose-
response relationship over the range of doses used. r ..,
Comments of the screening study contracted for by the National
Cancer Institute have already been published (18). The following
observations by the Panel are concerned with the portion of this
study in which the teratogenic potential of 2,4,5-T was tested.
-------
1542 LEGAL COMPILATION—PESTICIDES
1. The study involved a great number of variations in procedure
(strain of mice used, dates when tests were performed, and routes
of administration). These variations make the task of evaluation
difficult.
2. Too few animals and litters of animals were used. Since bio-
logical variability is considerable, the sample size must be ade-
quately large to demonstrate specific effects of the chemical agents
in question. At least 10 pregnant females to assure at least 100
conceptions is suggested. The Food and Drug Administration sug-
gests 20 females per test group.
3. There appears to be an unusually high level of embryo le-
thality and teratogenicity among untreated and vehicle-treated
groups. Either the experimental conditions were less than optimal
or the strain of animals was developmentally unstable.
4. The strain of mouse most often used (C57BL/6) appeared to
have had undesirable traits as a test animal, being variably and
uncertainly responsive to the substance being tested. A reasonably
homogeneous, colony-bred stock which has been maintained in
the laboratory long enough for the investigator to have accumu-
lated substantial background data on fecundity, spontaneous mal-
formation and intrauterine death rates is generally regarded as
preferable to inbred stocks for teratological testing. , ._,
TABLE 5.—TERATOGENIC EVALUATION OF 2,4,5-T IN MICE (2)
Compound
Vehicle
Dose
(mg/kg)
Fetal
Live mortal-
Litters fetuses ity per
(No.) per litter litter
(av. No.) (per-
cent)
Ab-
normal I
litters p<
(per-
cent)
Ab-
normal
fetuses
Percentage of
fetuses per
litter with:
(per- Cleft Cystic
cent) palate kidney
C57BL/6 strain treated days 6 to 14
Nontreated.
Control
Control
2,4,5-T
2,4,5-T
2,4,5-T
2,4,5-T
None
DMSO
Honey
DMSO.--.
DMSO....
Honey
Honey
None
C)
° 21,
113.0
46.4
113.0
72
106
32
6
18
6
12
5.8
5.5
7.1
7.7
4.4
8.5
4.8
26
29
15
3
42
8
t47
38
42
41
50
+86
tioo
tioo
11
12
14
12
t57
»37
t?0
0
0
t22
t23
1
2
1
0
t41
t33
t48
C57BL/6 strain treated days 9 to 17
Nontreated.
Control
2,4,5-T
None
DMSO..-_
DMSO....
None..
"HM
8
10
10
5.1
6.1
7.7
AKR strain treated days 6 to
Nontreated
Control
Control
2.4,5-T
2,4,5-T
None
DMSO....
Honey
DMSO
Honey
None
(C)
113.0
113.0
58
72
12
14
7
7.1
6.9
8.8
6.9
5.3
36
23
11
15
16
15
9
23
J42
71
30
tioo
19
24
0
tioo
31
8
t77
5
4
0
t29
t55
0
0
t29
0
t28
t55
7
0
teo
0
i
0
•Dose, 100 piper mouse.
tP=.01.
}P=.05.
-------
GUIDELINES AND REPORTS 1543
TABLE 6.-TERATOGENIC EVALUATION OF 2,4,5-T IN RATS
Dose
Compound Vehicle (mg/kg)
Nontreated
Control
2,4,5-T
245-T
2,4,5-T
None
Honey (t)
Honey 4.6
Honey 10.0
Honey 46.4
Average Percent P
No. of No. live fetal
litters fetuses/ mortal-
litter ity/htter
7
14
8
7
6
99
8.7
8.2
7.1
27
11
1
12
•"28
"•59
'ercent
Percent of fetuses
Percent per litter with:
mal mal Enlarged
litters fetuses/ renal
litter pelvis
43
57
88
86
67
9
12
"36
"46
§60
9
12
11
17
27
Cystic
kidney
0
21
"30
§33
t200^l/rat(2).
"Statistical Significance Level=0.05.
"•Statistical Significance Level=0.01.
§The sample size was possibly too small to show a significant difference.
5. It is puzzling that virtually no skeletal malformations were
encountered in either controls or test group. Skeletal defects
usually account for a substantial part of the easily detectable mal-
formations that occur spontaneously or after treatment in rodent
species. Hardly a strain that has been carefully studied in properly
cleared and stained specimens has failed to show vertebral and rib
variations.
6. There were some known teratogens used in these experiments
(trypan blue, 6-aminonicotinamide). It is puzzling to find that
these agents failed to produce significant teratogenic and embryo-
lethal effects consistently. This raises questions about the preci-
sion with which these teratogenicity tests were performed.
[p. 46]
7. 2,4,5-T appeared to be clearly teratogenic in two strains of
mice treated with 2,4,5-T at 113 mg/kg via either of the two
routes of administration. In rats, 2,4,5-T appeared only equivo-
cally teratogenic at any dosage but clearly embryo-lethal from
10.0-46.4 mg/kg.
8. The lack of an unequivocally defined dose-response relation-
ship renders these results less than completely satisfying.
REPORTS OP BIRTH DEFECTS AMONG HUMANS FOLLOWING EXPOSURE
TO 2,4,5-T
Shortly after the report of the teratogenesis screening in experi-
mental animals of pesticides, there appeared a series of articles
in the lay press which described the occurrence of birth defects
in parts of Vietnam where defoliants had been used. These articles
appeared in at least six different newspapers in South Vietnam
between June 26 and July 5, 1969. Both congenital abnormalities
and hydatid moles* were described. Translations of the articles
• (An abnormality of pregnancy which involves the placenta and the membranes surround-
ing the fetus.)
-------
1544 LEGAL COMPILATION—PESTICIDES
have alluded to the possibility that defoliants might be responsible
for these defects. The implication was offered that these abnor-
malities had increased in frequency in the recent past. No docu-
mentation has been available.
TOXICITY OF DIOXIN
It was pointed out in an earlier section of this report that one of
the impurities which arises in the manufacturing process of
2,4,5-T is 2,3,7,8-tetrachlorodibenzo-p-dioxin. This substance has
considerable interest because it is highly toxic, because a close
relative was a toxic constituent in chicken feed and because it has
caused chloracne, a severe skin disease, among workers engaged
in the manufacture of 2,4,5-T.
The dioxin impurity has assumed a further importance as an
impurity in commercially available 2,4,5-T. With the observation
that production lots of 2,4,5-T containing approximately 27 ppm
dioxin could be teratogenic, it became important to ascertain
whether it was 2,4,5-T itself or some impurity which was the
teratogen. Recent experiments at the National Institute of En-
vironmental Health Services indicate that partially purified
2,4,5-T (<0.1 ppm tetrachlorodibenzo-p-dioxin) shows terato-
genic activity in the mouse. Pure tetrachlorodibenzo-p-dioxin
shows teratogenic activity also, but not at low enough doses to
account for the activity of the partially purified 2,4,5-T. We
cannot exclude the possibility that other impurities may contribute
significantly to the observed teratogenic activity of 2,4,5-T.
[p. 47]
In the following paragraphs, the history of the discovery of
dioxin is examined in relation to the experimental observation of
the teratogenic properties of 2,4,5-T. Secondly, data on the toxicity
of this material are presented.
In March 1949, an accident occurred at a 2,4,5-T plant owned by
the Monsanto Chemical Company which led to the release of some
of the intermediate chemicals into the plant. As a result, 117
cases of a severe skin disease known as chloracne were found
among the exposed workers. Chloracne is characterized by come-
dones, blackheads, inclusion cysts, and pustules with eventual
scarring over the neck, back, and chest. In addition to the cases
which were traced to the accident, a number of other clinical
cases of chloracne were recognized among workers in the 2,4,5-T
plant who were not in the vicinity of the accident. (10) Kimmig and
Schulz (11) reported in 1957 that chloracne occurred among work-
ers engaged in the manufacture of 2,4,5-T in Germany. These au-
-------
GUIDELINES AND REPORTS 1545
thors demonstrated that the agent responsible for chloracne was tet-
rachlorodioxin. In 1964, the demand for 2,4,5-T in the United States
began to rise mainly due to its increasing use as a defoliant in
Vietnam. A greater demand was placed on each of the domestic
manufacturers to produce more herbicide. Coincident with the
increased production was the discovery of chloracne among some
60 2,4,5-T workers. (7) The Dow Chemical Company reduced its
operations substantially for a period of several months in order
to investigate the origin of the toxic hazard. It was found that the
amount of dioxin formed varied with the temperature and pres-
sure of the early reaction steps. The Dow Chemical Company
made its findings known to the other domestic manufacturers.
Looking back it is evident that dioxin levels varied widely among
commercial 2,4,5-T samples, as seen in Table 4 of Section III.
Rigorous control is now exercised to reduce dioxin levels in the
final product to less than 1 ppm.
A recent review of occupational disease attributed to dioxin
has been prepared by Poland et al. (15). These authors studied 73
male employees in a 2,4,5-T factory, some of whom had been ob-
served six years previously by Bleiberg (1) who then noted the
prevalence of chloracne. Poland et al. (15) also found chloracne
among the same population although estimates of exposures were
not made. Poland attributed the chloracne to the dioxin impurity.
They also examined the prevalence of a type of porphyria, thought
to be toxic in origin, known as porphyria cutanea tarda (elevated
urinary porphyrin excretion, skin fragility and vesicular erup-
tions) . Uroporphyrinuria had been noted during the early visit to
the plant by Bleiberg (1) but it was not found during the later
study. Elevated urinary coproporphyrin levels were noted, however,
but there appeared to be no correlation with the severity or pres-
ence of chloracne (1, 15). The later series of observations found
much of the chloracne still remaining
[P. 48]
but the porphyria had disappeared. Chloracne was attributed to
the dioxin impurity but the origin of the porphyria was less certain.
In order to measure the toxicity of the dioxin impurity, the
Dow Chemical Company undertook a series of acute toxicity
studies on small animals in 1967 (16). Single doses of 2,3,7,8-
tetrachlorodibenzo-p-dioxin were administered orally to lots of
five animals for each of several doses. The number surviving and
the time of death were noted. The animals used were male rats,
female rats and female guinea pigs. Table 7 gives the results of
these experiments:
-------
1546 LEGAL COMPILATION — PESTICIDES
TABLE 7.— Single-dose oral toxicity of dioxin (18)
Male rat _________________________________________________________ 0.022
Female rat ------------------------------------------------------- .045
Female guinea pig ________________________________________________ .0006
With this background in mind, the purity of the 2,4,5-T ma-
terial used in the National Cancer Institute screening study
assumed a new importance. A sample of this material was sub-
mitted to chemical analysis by gas chromatography. The result
was the finding of 27 ± 8 ppm of dioxin.
TESTING FOR TERATOGENICITY
The study of teratogenic effects in experimental animals is
characterized by a great deal of empiricism. However, in general
testing for teratogenic potential is a more manageable problem
than are a number of other types of biologic testing. There are
large numbers of agents known to be teratogenic to animals. In
fact, it has been held that virtually any material is potentially
teratogenic if administered in an appropriate dose at the critical
time in gestation. Interestingly, however, only a few chemicals
have been recognized as human teratogens.
In general, an embryo-toxic dose of a material is separated from
a maternal toxic dose by a small margin (perhaps no more than
a factor of 10). Only slightly below the embryo-lethal or toxic
dose is a no-effect dose (separated, perhaps, by a factor of 2) .
Between the highest level which has no effect on the developing
fetus and the embryo toxic level is a steep dose-response relation-
ship. In testing for teratogenicity, the lowest dose on the dose-
response curve (threshold for any embryo toxicity) is identified.
All doses below this level are, by definition, no effect doses. By
accepting an extra margin of safety below this dose (a factor of
1/10-1/100), reasonable freedom from teratogenic effects can
be predicted.
A problem arises in extrapolating findings in experimental ani-
mals to man. The embryotoxicity of a chemical agent is, in theory,
a function [p 49]
of the degree of exposure of the developing embryo to
the agent. This appears to be a function, in turn, of the persistence
of the material in the maternal circulation. Thus, in order to
extrapolate animal findings to humans, the animal must be "cali-
-------
GUIDELINES AND REPORTS 1547
brated" to humans for each chemical agent. That is, the rate of
disappearance of the agent from the animal circulation must be
compared quantitatively to that in humans. As a first approxima-
tion, corresponding doses in mg/kg would be taken as proportional
to the blood clearance rates for the two species.
These principles make possible the design of testing procedures
for reproductive defects caused by chemical substances. The
scheme described is of a general nature but can be applied to
2,4,5-T. The first step involves determination of the chemical na-
ture of the material in question. Secondly, animal studies should
be done to establish embryotoxic levels. In the case of 2,4,5-T,
some additional studies have been carried out to confirm the re-
sults of the National Cancer Institute screening study. In addition,
studies should be undertaken on pure 2,4,5-T and on its various
impurities to identify the teratogenic agent or agents. Hybrid
strains of animals should be used rather than highly inbred
strains. At least two animal species should be used. Preferably
strains of colony or random bred rats and mice should be used
which have been maintained in the laboratory long enough for
the investigator to have accumulated substantial background data
on fecundity, spontaneous malformations and intrauterine death
rates.
By careful testing, using a small series of doses, a TD50 dose
(that dose which will cause teratogenesis in 50 percent of fetuses)
can be ascertained. At the low end of the dose-response curve is
found, presumably, a threshold dose below which no detectable
teratogenic effects would be expected. Actual experimentation
locates TD»maii at which teratogenicity occurs in only a few per-
cent of all fetuses.
The next step is to compare the expected human exposure with
the animal TD,™ii. If these differ by as much as a factor of 100,
it would seem reasonable to consider the material safe with regard
to teratogenesis. If the difference between the human exposure
and the animal TDsmou is as little as a factor of 10, the margin
probably is insufficient. Between 100 and 10 lies a certain amount
of flexibility for further action. Finally, in order to extrapolate
the animal data to human experience, rates of excretion and de-
toxification in animals and humans should be compared.
SUMMARY OP RECENT EXPERIMENTS
Following analysis of the results of the screening study carried
out for the National Cancer Institute, it was felt that confirmatory
studies should be undertaken. Two sets of experiments were
-------
1548 LEGAL COMPILATION—PESTICIDES
begun independently by the Dow Chemical Company and by the
National r __,
[p. 50]
Institute of Environmental Health Sciences. At the time of this
writing, some of these experiments have been completed and the
results have been reportd.
1. Dow experiments.
2,4,5-T (containing
-------
GUIDELINES AND REPORTS 1549
narrower range of doses was tested. In rats, the dosage range was
10.0-21.5 mg/kg/day and here the material was administered
orally in sucrose. Pure dioxin was administered subcutaneously in
DMSO in rats and mice (1 and 3 mg/kg/day in mice and 0.5 and
2 mg/kg in rats).
In mice, both 2,4,5-T (in the purest form available) and dioxin
produced birth defects and increased fetal toxicity. The birth
defects were qualitatively similar to those seen previously in the
National Cancer Institute screening study and included cleft
palates and r C11
LP-51J
renal defects. In rats renal defects and excess fetal mortality
were seen but seemed to be related to dioxin content rather than
2,4,5-T.
3. FDA Experiments (unpublished data acquired in the spring
of 1970).
Teratogenic studies were performed by giving the test com-
pound by oral intubation to pregnant hamsters on day 6 through
10 of organogenesis. Embryos were removed by caesarian section
on day 14 of pregnancy. Samples of 2,4,5-T tested were:
a. "Dow Technical"—contained ^ 0.5 ppm dioxin.
b. "Dow Technical"—contained <: 0.1 ppm dioxin.
e. "Dow Pure"—contained ^ 0.1 ppm dioxin.
d. Hercules X-17394—contained no detectable dioxin.
e. Monsanto NL-07-020—contained 2.9 ppm dioxin.
f. "K & K" sample—contained about 45 ppm dioxin.
g. Eastman Kodak (recrystallized in FDA)—contained no de-
tectable dioxin.
In addition pure 2,3,7,8-tetrachlorodibenzo-p-dioxin (Dow)
was administered to hamsters.
These materials were tested in various doses from 40-100 mg/
kg. All of the 2,4,5-T samples produced increased embryotoxicity
and gastric and/or intestinal hemorrhages. Birth defects consisted
chiefly of poor head fusion and absence of eyelids.
The pure tetradioxin produced increased fetal toxicity at 0.31
and 1.43 fig/kg and gastric and/or intestinal hemorrhages at the
lowest dose, 0.02 jug/kg.
REFERENCES
(1) BLEIBERG, J., WALLEN, M., BRODKJN, R., and APPELBAUM, I., Arch. Derm
89 =793,1964.
(S) COURTNEY, K. D., GAYLOR, D. W., HOGAN, M. D., and FAIX, H. L., Tera-
-------
1550 LEGAL COMPILATION—PESTICIDES
togenic evaluation of 2,4,5-T. Manuscript submitted for publication
(1970).
(8) DALGAARD-MKKELSEN, S. and PAULSEN, E., Rev. 14:225,1962.
(4) Dow Chemical Company, personal communication.
(5) DRILL, V. A., and HIBATZKA, T., AM A Archives of Industrial Hygiene and
Occupational Medicine, 7:61,1953.
(6) EMERSON, J.C., THOMPSON, D. J., GERBIG, C. G., ROBINSON, V. B., Terato-
genic study of 2,4,5-trichlorophenoxy acetic acid in the rat. Presented
at the meeting of the Society of Toxicology, Atlanta, Georgia, March
17,1970 (abstract).
(7) HOLDER, B., Occupational Medicine Department, Dow Chemical Com-
pany. Personal communication.
(8) HOUSE, W. B., GOODSON, L. H., GADBERRY, H. M., and DOCKTER, K. W.,
Assessment of ecological effects of extensive or repeated use of herbi-
cides. Midwest Research Institute. Project No. 3103-B. December 1967.
(9) INNES, J. R. M., ULLAND, B. M., VALERIO, M. G., PETRUCELH, L., FISH-
BEIN, L., HART, E. R., PALLOTTA, A. J., BATES, R. R., FALK, H. L.,
GAST, J. J., KLEIN, M., MITCHELL, I., and PETERS, J., J. Nat. Cancer
Institute 42:1101,1969. r 52]
(10) Kettering, Laboratory, Unpublished reports. Department of Preventive
Medicine and Industrial Health, College of Medicine, University of
Cincinnati, Cincinnati, Ohio.
(11) KIMMIG, J., and SCHULZ, K.D., Dermatologica 115:54:0,1957.
(12) National Cancer Institute. Evaluation o,f the carcinogenic, tera togenic
and mutagenic activities of selected pesticides and industrial chem-
icals. 4 vols. Bionetics Research Laboratories, 7300 Pearl St., Bethesda,
Md., 1967.
(IS) National Institute of Environmental Health Sciences, unpublished data.
(14) PALMER, J. S., and RADELEFF, R. D., Ann. N. Y. Acad. Sci. S :729, 1964.
(15) POLAND, A. P., SMITH, D., METTES, G., and POSSICK, P., A health survey
of workers in a 2,4-D and 2,4,5-T plant: with special attention to
chloroacne, porphyria cutanea tarda and psychologic parameters. Man-
uscript in preparation, 1970.
(16) ROWE, V. K., Personal communication, 1970.
(17) ROWE, V. K. and HYMAS, T. A., Amer. J. Vet. Res. 15:622,1954.
(18) U.S. Department of Health, Education, and Welfare, Report of the
Secretary's Commission on Pesticides and Their Relationship to
Environmental Health, December 1969.
(19) WAY.J. M., Residue Rev. 26:37,1969. [p. 53]
RESIDUES OF 2,4,5-T IN THE ENVIRONMENT
SUMMARY
2,4,5-T residues disappear from soil with moderate speed, prob-
ably through action of microorganisms, persisting as long as three
months. During this period they are potentially available for trans-
port to non-target areas.
It appears unlikely that residues from recommended applica-
tions of 2,4,5-T could appear in hazardous quantities in water.
-------
GUIDELINES AND REPORTS 1551
Typical applications are to forested areas or those infested by
weeds where most of the herbicide appears to be intercepted by
the plants. Residues do not seem to persist in water, however, they
do remain longer in bottom sediments.
Residues from rangeland and pasture applications may find
their way into cattle permitted to graze soon after spraying. Cattle
excrete the intact herbicide rapidly but 2,4,5-T residues have
occasionally been found in meat and dairy products. Although the
residue levels are low, they dictate caution about pasturing soon
after rangeland treatment.
The rate of application of 2,4,5-T in Vietnam is 13 Ibs. of the
butyl ester per acre (26 Ibs. of Orange per acre). This rate is about
2-6 times as high as that used on rangelands domestically. More-
over, much larger areas are treated in Vietnam. Orange is not used
on food crops but on forests. Hence, human exposure to contami-
nated food crops would be unlikely. If, during the vulnerable
period of gestation, all a pregnant mother's food came from loca-
tions treated with Orange at 26 Ibs/acre within the preceding
week or so, the daily dose of 2,4,5-T might conceivably reach 15
mg/kg/day, which by comparison to some animal data might
prove to be embryotoxic. Such estimates are based on a very ex-
treme, worst-case calculation.
RESIDUES OF 2,4,5-T RESULTING FROM RECOMMENDED USES IN THE
UNITED STATES
The herbicide 2,4,5-T is applied for weed control to a relatively
few crops. However, it is used more extensively for control of
weeds in rangelands and pastures, non-croplands and aquatic areas
(Table 1). [p54]
It is not considered to be a persistent pesticide by com-
parison with many of the chlorinated hydrocarbon insecticides.
Nevertheless, its use at rates of recommended application results
in measurable levels of residue in soils, water, air, plants, and
animals which persist for relatively short periods of time after
application. The potential effects of such residues on the health of
man and other animals have been little studied and are poorly un-
derstood. Data available suggest that residues resulting from
recommended rates of application are not of sufficient magnitude
to justify concern as potential health hazards. Unfortunately, most
of the toxicity studies conducted thus far have been relatively
short-termed and of value for determining acutely toxic doses only.
Substantial amounts of data are available of the sort reported by
-------
1552 LEGAL COMPILATION—PESTICIDES
Palmer and Radeleff (14). Data from such studies indicate that
2,4,5-T is not acutely hazardous for cattle, sheep, and chickens
when applied at recommended rates. They considered rates of
application above 30 pounds per acre to be hazardous.
Recent concern over the possible adverse effects of long-term
exposure to relatively small amounts of 2,4,5-T as residues in food,
feed, and water makes it desirable to review the information
available on levels and persistence of such residues.
1. Soils—The possibility of residual toxicity to crops grown on
soils treated with 2,4,5-T has emphasized the need for infoimation
on the levels of residues resulting from various rates of application
and their persistence. Substantial amounts of data have been
accumulated on these points and there is relatively good agree-
ment in results of most studies. Taking into account differences in
soil type, temperature, and moisture and the phenomenon of bac-
terial proliferation in response to a new substrate, it appears that
2,4,5-T residues in soils may persist for as long as three months.
The persistency of residues seems to be independent of the rate of
application.
TABLE l.-SOME EXAMPLES OF DOMESTIC USES OF 2,4,5-T FOR CONTROL OF WEEDS. (SUGGESTED GUIDE FOR
WEED CONTROL, 1969). U.S.D.A. AGRICULTURE HANDBOOK NO. 332
Rate of
Crop or area application
pounds per A
Sugarcane _ _. _. 1.0
Grasses grown for seed - 0.75
Rice _ 0.5-1.5
Permanent pastures and rangelands 0.5-8.0
Non-cropland, rights-of-way, floodways, ditchbanks, fance rows, and industrial sites 1.0-4.0
Aquatic weeds _. 1.0-4.0
Laboratory studies suggest that breakdown of 2,4,5-T residues
in soils result from the action of microorganisms which are ca-
pable of using these chemicals as sources of energy and carbon.
Two species have been reported to use 2,4,5-T as a source for
energy and carbon. (1) The microbiological degradation of the
phenoxyacetic acid herbicides in the forest floor material probably
resembles that in soils. (13) -p 55-1
Under the conditions of this environment substantial amounts of
2,4,5-T remained after 4 months. The relatively rapid degrada-
tion of residues of phenoxyacetic acid herbicides in the soil makes
it unlikely that there will be any accumulation of 2,4,5-T from one
season to the next. Rates of removal from soils by plants and
invertebrates are uncertain.
A major concern about residues of persistent pesticides is that
they do not always stay in the target area. The fact that residues
-------
GUIDELINES AND REPORTS 1553
of 2,4,5-T may remain in the soil for periods of three months, or
more, makes it subject to transport to non-target areas. Soil par-
ticles contaminated with 2,4,5-T may be transported by wind or
water to areas far removed from the site of application. The ex-
tent to which this occurs seems to have received little or no
attention.
The choice among esters is often influenced by such considera-
tions as reduced volatility (which may reduce spreading to non-
target plants), slowness of hydrolysis, and avoidance of crystal-
lization after the vehicle has evaporated.
Experiments on leaching of 2,4,5-T products and vehicles sug-
gest that amine salts are leached more rapidly than the free acid
(8).
2. Water—Residues of pesticides in water are of concern because
of the possibility of their getting into drinking water for man and
other animals, of their potential adverse effects on aquatic orga-
nisms, and of the potential adverse effect on sensitive crop plants
of irrigation water contaminated with these chemicals. Contami-
nation of surface waters with herbicide residues is a matter
of special concern since surface water provides most municipal
water supplies. Nearly all of the water for livestock and other
animals is supplied from surface water.
Since nearly 100 million acres of land are treated with herbi-
cides in the United States each year, about 3 million acres of which
are forest or rangelands, it is inevitable that substantial contami-
nation of surface water occurs. However, most of the contamina-
tion is indirect as a result of drift from target areas.
The manner in which contamination occurs, whether from drift
or from direct application, determines the level of residues depos-
ited. In applications made to forested areas or to bodies of water
heavily infested by weeds extending above the water, much of the
total amount of herbicide applied will not reach the water directly.
As much as 88 percent of the total amount applied may be inter-
cepted by such plant covers as liveoak which are much less dense
than those of water hyacinth or alligator weed. (16) There appears
to be little information available on the possibility of future release
to water of residues in plants.
Streams in forests in Oregon sprayed with 2,4,5-T or mixtures
of 2,4,5-T and 2,4-D in a 1:1 ratio at the rate of 2 pounds per
acre showed maximum residues of 70 ppb which disappeared with-
in 17 days. (15) [-p 5g-|
Even at the heaviest rate of application recommended for con-
trol of weeds in permanent pastures and rangelands and aquatic
-------
1554 LEGAL COMPILATION—PESTICIDES
species, 2,4,5-T residues would not be substantial even at the
maximum levels that could be expected. For example, 8 pounds of
herbicide per acre applied to a body of water 3 inches deep would
result in residues of only 12 ppm, Table 2. An animal drinking
from even such an unusually shallow source could not get a dose
that would be expected to cause chronic toxicity. For example, a
cow weighing 500 kg may be expected to drink as much as 50 1. of
water per day during the warm seasons of the year which would
result in the ingestion of about 1.2 mg/kg/day. However, a more
realistic example could be expected from applications of 2,4,5-T
to rangelands at 4 pounds per acre. Treatment of a body of water
one foot deep at this rate would result in residues of only 1.5 mg/1.
A 500 kg cow drinking from such a source could get no morn than
0.15 mg/kg/day.
Adverse effects of residues of 2,4,5-T on aquatic species such
as fish and some of the bottom dwelling invertebrates might be
expected from the heavier recommended uses of this herbicide to
shallow bodies of water. For example, 24-hr. LC50* for bluegil] is
1. (4 ppm for the butoxyethanol ester of 2,4,5-T (see table 1 on page
67). Concentrations higher than this would result from the direct
application of 4 pounds per acre to bodies of water no more than
6 in. deep.
TABLE 2.-ESTIMATED MAXIMUM LEVEL (MG/L.) OF RESIDUES OF 2,4,5-T AT VARIOUS RATES OF APPLICA-
TION TO BODIES OF WATER RANGING FROM 3 INCHES TO 10 FEET IN DEPTH.
Rates of application, pounds per A
Depth of Water
20 26 80 100
3 inches
6 inches _ .
Hoot ....
2 feet
3 feet
4 feet
5 feet....
6 feet
7 feet...
8 feet
9 feet
10 feet
1.5
0.75
0.38
0.19
0.13
0.09
0.08
0.06
0.05
0.05
0.04
0.04
3.0
1.50
0.75
0.38
0.25
0.19
0.15
0.13
0.11
0.09
0.08
0.08
6.0
3.0
1.50
0.75
0.50
0.38
0.30
0.25
0.21
0.19
0.17
0.15
9.0
4.50
2.25
1.13
0.75
0.56
0.45
0.38
0.32
0.28
0.25
0.23
30.0
15.00
7.50
3.75
2.50
1.88
1.50
1.25
1.07
0.94
0.83
0.75
39.0
19.50
9.75
4.88
3.25
2.44
1.95
1.63
1.39
1.22
1.08
0.98
120.0
60.0
30.0
15.0
10.0
7.5(1
6.0(1
5.0(1
4.2!<
3.7!'
3.3:;
3.0(i
150.0
75.0
37.50
18.75
12.50
9.38
7.50
6.25
5.36
4.69
4.17
3.75
There appears to be little likelihood of 2,4,5-T appearing in haz-
ardous quantities in ground water or drainage channels from local
applications. Brown and Nishoka (3) reported that 2,4,5-T was
not detectable in samples of water-suspended sediment mixtures
from 11 streams in the western United States.
* LCso, median lethal concentration of a toxicant, typically placed in the ambient environ-
ment of the organisms whose survival is measured. Usually, the environment in question is
aquatic. The terms, LDjo and LCso, may be used interchangeably for aquatic organisms.
-------
GUIDELINES AND REPORTS 1555
However, a subsequent study of the same streams (11) making
use of improved techniques showed 28 of 235 samples taken from
17 rivers during 1966-68 to be positive for 2,4,5-T residues.
Twenty-one of these
r
Lp.
were from three rivers, the Arkansas, Brazos, and Canadian. All
of the seven samples taken from the latter were positive. The
amount of residues found was extremely small, ranging from 0.01
to 0.07 ppb. Samples were taken uniformly throughout the year
and there appeared to be little effect of season on incidence or
levels of 2,4,5-T residues.
Samples were analyzed as received with no effort made to sepa-
rate water and sediments. It is possible that a high percentage of
the residues was contained in the sediment since there is evidence
that phenoxyacetic acid herbicide residues persist longer in sedi-
ments than in water. In either case, these data provide strong evi-
dence that residues of 2,4,5-T in water which result from use of
the herbicide in this country are not hazardous.
3. Plants — The levels of residues of 2,4,5-T in plants have re-
ceived much less attention than has been devoted to insecticide
residues. The comparatively short residual life of this material
together with the fact that it is usually applied several weeks, or
even months, in advance of harvesting dates, has allowed it to be
used in most cases without danger of significant residues in the
harvested product. However, it is recommended for control of
weeds in permanent pastures and rangelands at rates which result
in significant levels of residues that have been reported to persist,
under some conditions, for as long as 6 weeks, Table 3. However,
there has been relatively good agreement in results obtained by
various workers who have reported on persistence of residues of
2,4,5-T applied to forage grasses in rangelands and pastures. The
data of Morton, et al. (12) indicate levels in pasture grasses rang-
ing from 10 to 32 ppm after about one month which agrees reason-
ably well with the 7 ppm reported by Baur, et al. (2) in range
forage grasses. r _0,
[p. 58]
Substantial levels of residues occur in forage plants treated
with 2,4,5-T at 2 Ibs/acre, and appreciable quantities sometimes
persist for as long as 3 weeks. This suggests that beef cattle per-
mitted to graze pastures or rangelands immediately after treat-
ment, or that dairy cattle permitted to graze such areas 7 days
after application at maximum rates recommended, may be ex-
posed to dosages that are too high for safety (Table 4) . Estimates
of the levels of residues that might occur in forage grasses treated
-------
1556 LEGAL COMPILATION—PESTICIDES
TABLE 3.-RATE OF DISAPPEARANCE OF 2,4,5-T RESIDUES FROM VARIOUS TYPES OF FORAGE CROPS.
ESTIMATED FROM SEMI-LOGARITHMIC PLOTS IN FIGURES 1-4. (12)
Concentration, ppm (2,4,5-T)
2 pounds
No. days from treatment per Abu- 2 pounds 1 pound
toxyethyl- per A acid per A amine
ester
0
2
4
7
14
21
28
35
42
49
56
63
70
77
84
91
98
300
130
70
55
45
_. 32
20
12
7
100
70
35
20
l!i
1?
1)
11
11
8
7
6
5
4
3
100
70
45
30
15
10
8
6
5
4
3
3
2
2
at higher rates indicate a possibility of transfer of residues to
milk and even chronic toxicity (Table 4). However, the fact that
no evidence of toxic effects has been reported and that residues of
2,4,5-T have been rarely found, and even when found have been
at very low levels in dairy products that have been analyzed by
FDA in total diet studies, argues against the probability that
residues of this herbicide in forage crops pose any significant
hazard.
TABLE 4.-ESTIMATED RATES OF DISAPPEARANCE OF 2,4,5-T RESIDUES FROM FORAGE TREAT ED AT DIF-
FERENT RATES WITH CORRESPONDING MAXIMUM AMOUNTS OF HERBICIDE THAT MIGHT BE
INGESTED BY CATTLE PASTURED ON FORAGE TREATED AT THE RATES INDICATED.
2,4,5-T butoxyethylester
O1 . .
1
2 _
3
4
5
6 . ...
7 . ...
8 ....
2 Ibs/A'
mg/kg in nig/kg/day4
forage ingested
300 25
130 11
.. -. 70 6
55 4
45 4
32 3
20 2
12 1
.. ... 7 0.6
4 lbs/AJ
mg/kg in mg/kg/day*
forage ingested
600 50
260 22
140 12
110 8
90 8
64 6
40 4
24 2
14 1.2
1 Within 30 mm. of treatment.
2 Estimated from semiloganthmic plots of graph in Table 2. (16).
1 Extrapolated from ' using maximum rates of 2,4,5-T recommended for permanent pastures and rangelemds in Agri-
culture Handbook No. 332, 1969.
• Assuming a 500 kg cow eating 45 kg forage per day.
4. Animals—Residues of 2,4,5-T in animals, as in plants have
received much less attention than some of the fat soluble, long-
persisting organochlorine insecticides. The residues that occur
-------
GUIDELINES AND REPORTS 1557
from ingestion of the phenoxy herbicides are eliminated rapidly
and there is evidence that accumulation occurs in only a few
species. Erne (6) in one of the most thorough studies of the dis-
tribution and elimination of 2,4,5-T reported that it was readily
absorbed and distributed completely in the body. He found that
it was eliminated rapidly. Plasma half-life values from single oral
doses of 100 mg/kg of the amine salt to male rats and pigs were
3 and 10 hours, respectively. Highest levels of residues were found
in the kidney, liver, lungs, and spleen with levels sometimes ex-
ceeding plasma levels. There was little evidence of penetration
into the brain or adipose tissues. The main
[p. 59]
excretory route was the kidney. His data (7) showing weak but
"certain" protein binding of 2,4-D suggest that this may also
occur with 2,4,5-T.
5. Food and feed—Results of studies of pesticide chemical resi-
dues in total diet samples by the Food and Drug Administration
during the period 1964-68 provide convincing evidence that 2,4,5-T
residues are not a significant health hazard in food in the United
States. During this 5-year period 30 composite samples of about
82 food items each have been collected each year from retail mar-
kets in 25 or more cities. Each composite sample, representing a
2-week diet for a 16- to 19-year-old male, is analyzed by multi-
residue methods for more than 60 chlorinated organic and organo-
phosphorus insecticides and for herbicides, carbamates, and se-
lected inorganic chemical residues. Examination of these samples
is carried out at levels of sensitivity much lower than those nor-
mally used for products tested for compliance with tolerances.
Data reported for the period June 1967-April 1968 (k) show
incidence and levels of 2,4,5-T residues that are typical. Only one
sample of dairy products was contaminated. About 2 percent of
dairy products and 1 percent of meat, fish, and poultry were re-
ported to contain residues of 2,4,5-T. All of these residues were
at trace levels, below 0.01 ppm. No residues of 2,4,5-T were found
in any of the other 10 classes of foods.
It is significant that residues of 2,4,5-T were detected only in
foods of animal origin. The most likely source is forage from pas-
tures and rangelands treated with 2,4,5-T for weed or brush
control.
Duggan and Lipscomb (5) summarized the results of sampling
for herbicide residues in prepared food from the total diet studies
over a period of four years. From these studies, they estimated
-------
1558 LEGAL COMPILATION—PESTICIDES
the likely dietary intake of all of the herbicides searched for to
below:
Estimated
dietary
Year intake
(mg/kg/day)
1965 0.0012
1966 0.00022
1967 _ . . .. 0.00005
1968 O.OOOOE
Since 2,4,5-T residues are only a small percentage of these total
herbicide residues found in foods it seems safe to conclude that
there is little likelihood of exposure from this source.
Residues of 2,4-D and 2,4,5-T resulting from recommended uses
by the military for defoliation.
All the available evidence indicates that 2,4-D and 2,4,5-T
behave similarly in animals with respect to absorption, distribu-
tion, metab-
[p. 60]
olism, and elimination. Since mixtures of these herbicides are
used in the defoliation program in Vietnam, it does not appear
reasonable to consider them separately.
The large-scale application of 2,4-D-2,4,5-T mixtures for de-
foliating military target areas in Vietnam poses some possible
unique hazards to humans. Application rates of about 26 Ibs/acre
of a 1:1 mixture of the n-butyl esters of the chemicals are generally
heavier than those used for agriculture and brush clearing in the
United States. (There have been a few, limited applications of
2,4-D reported to lakes, streams, and reservoirs in the United
States at rates of 80-100 Ibs/acre for aquatic weed control.) There
are other differences. There are vastly greater areas involved in
Vietnam. Because of the nature of the military targets—heavily
wooded, jungle areas—it is not likely that many crops are grown
in or near treated areas. Although defoliation procedures appear
to be under rigid control with all reasonable precautions taken to
prevent application to crops, the nature of military operations
makes it likely that accidents may occur and that mistakes may
be made which result in direct applications to non-target areas.
In such cases it is possible that food crops and water supplies in
restricted localities could receive heavy doses of the 2,4-D-2,4,5-T
mixture. A much more likely possibility is drift of relatively small
amounts of the herbicides to non-target areas. The n-butyl esters
of both 2,4-D and 2,4,5-T are volatile and substantial amounts of
-------
GUIDELINES AND REPORTS 1559
both chemicals may vaporize at temperatures prevalent in Vietnam
and escape from the target area.
If mixtures of 2,4-D and 2,4,5-T were applied directly to food
crops at the rates being used in Vietnam for defoliation (about
26 Ibs/acre), it is theoretically possible that amounts potentially
hazardous to humans could be deposited on food. The butyl ester
of 2,4,5-T applied to an improved pasture at the rate of 2 pounds
per acre was found to result in an initial deposit of about 300 ppm
on the forage (12). Direct application to food crops at 26 pounds
per acre could not reasonably be expected to result in initial resi-
dues greater than 3900 ppm. Assuming initial residues on food
crops as high as 3900 ppm from direct application at the rate of
26 pounds per acre is unrealistic. Such an assumption requires
that: 1) surface/volume ratios of food items be similar to that
of forage grasses; 2) all portions of food items, e.g., husks of
corn, peels of banana, shells of coconut, be consumed; 3) there is
no loss of herbicide during preparation and cooking; and 4) trans-
location of herbicide into portions of the plants used for food,
e.g., root crops, banana pulp, and coconut flesh and milk, results
in residues as high as if these portions had been treated directly.
None of these is true. Some items of food could not be contami-
nated by direct contact with the spray formulation. Translocation
from foliage to underground roots of sweet potato and fruits of
peanut [p 61]
and into aboveground fruits such as coconut would be required
for these foods to be contaminated.
Table 5 breaks down an estimated diet for a 60-kilogram Viet-
namese into three parts according to the rapidity with which 2,4-
D and 2,4,5-T might be translocated into the portions consumed
for food.
Table 6 estimates the maximum believable concentrations of
the herbicides in such a diet as being 3900 ppm initially, 1560 ppm
after one week and 910 ppm after 2 weeks (See Table 2 for esti-
mated rates of disappearance of 2,4,5-T residues for forage). The
maximum dosage retained, substantially greater than any realistic
figures, is about 30/mg/kg/day.
The possibility that any of these assumptions might approach
reality is probably nil. Many crops that are treated directly at such
high rates show severe damage within a few days and would not be
harvested. Translocation or penetration of residues into coconut
meat and milk and banana pulp would take some time to occur, if
at all, and would probably be at levels much lower than amounts
-------
1560
LEGAL COMPILATION—PESTICIDES
TABLE 5.—Estimated for a 60-kilogram Vietnamese divided into three groups based on
the rapidity with which 2,b-D and %A,5-T, might be translocated into portions
consumed for food'
A. Foods into which very rapid movement is possible, not necessarily probable,
and maximum concentration is attained immediately
Dietary
portions
consumed
g/person/day
Leafy green vegetable 52
Other vegetables 196
Condiment vegetable 40
Bananas 107
Other fruits 75
Total 470
B. Foods into which moderately rapid movement is possible, though not neces-
sarily probable, and maximum concentration is attained within 1 week
Cereals 500
Fish and meat 311
Fish sauce 1
Spices 1
Coconut flesh 25
Coconut milk 12
Total 850
C. Foods into which movement is relatively slow and maximum concentration
is attained within 2 weeks
Root vegetables 80
Beverage 5
Sugar and vegetable oils 95
Total 180
1 Components of diet and amounts consumed adapted from "Federation of Malaya Nutrition
Surrey", Report Interdepartmental Committee for Nutrition for National Defense, 1964, 365 pp.
(Modified in consultation with Vietnamese students at Louisiana State University.)
[P. 62]
TABLE 6.-CALCULATION OF UPPER LIMITS FOR DAILY DOSE OF 2,4-D AND 2,4,5-T COMBINED WHEN ALL
FOOD IS FULLY EXPOSED TO ONE AERIAL APPLICATION AT 26 LBS/A.1
[Maximum possible contamination, mg/kg/day]
Food Group
gm/person/ After After
day Immediate 1 2
week weeks
Group A.
Group B.
Group C.
Total.
470
850 .
180 .
30
12 7
22 13
3
30 34 23E
> See Table 5.
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GUIDELINES AND REPORTS 1561
deposited on foliage. The amount of residues of these chemicals
that would penetrate into kernals of mature rice through palea
and lemma is probably a very small percentage, if any, of the dose
applied. There does not appear to be information on these points,
however.
Probably the greatest potential hazard from contaminated food
would be from ingesting leafy green vegetables, other vegetables,
and fruits.
Much of the drinking water in the villages of Vietnam is from
shallow, open wells and from rainwater collected from the roofs
of thatched houses. Direct application of heavy rates of herbicide
to these sources could result in the ingestion of substantial amounts
of the chemicals in rainwater collected from roofs of houses. As-
suming that about 270 mg of herbicide is applied per sq. ft. of
surface, that water supplies are collected from rain falling on a
roof having a total area of 200 sq. ft., and that all of the herbicide
is washed off immediately after application and collected in con-
tainers holding 200 liters, a 60 kg person drinking 3 1. of water
could get about 10 mg/kg/day. No information is available on the
amounts of these chemicals that can be washed off a thatched roof
by rainfall. However, data on rates of dissipation of 2,4-D and
2,4,5-T from dead litter material in pastures show rates of dis-
appearance slower than for green tissues (12). Thus, it appears
reasonable to expect considerably less than 100 percent of the
amount applied to be washed off a thatch roof treated with 2,4-D
and 2,4,5-T. Even if it were all washed off, it appears to be
unreasonable to expect it all to be captured in vessels having a com-
bined capacity of only 200 liters. Therefore, any reasonable as-
sumption would be that a person getting drinking water from
such a source contaminated at the maximum rate possible would
get much less than 10 mg/kg/day. rp gg-i
Drinking water from a shallow well contaminated at the max-
imum rate expected from a 26 Ib/acre application, assuming a
depth of 4 feet for water in the well, would amount to less than
0.5 mg/kg/day, and thus would pose no hazard.
Other possible routes of entry into humans from accidental
direct application to non-target areas would be by inhalation and
penetration through the skin. There is inadequate information
available on these points to form any concept of the potential
hazard of residues from these sources. Way (17) has suggested
that there is little hazard of transport across the skin barrier.
However, these materials are fat soluble which might encourage
their percutaneous absorption. At least one study of the acute
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1562 LEGAL COMPILATION—PESTICIDES
toxicity of the defoliant, Purple (esters of 2,4-D and 2,4,5-T),
suggested that skin absorption of the animals tested occurred but
was perhaps 10-20 times slower than absorption from the GI
tract (10). In the extreme situation of a nude, pregnant female,
prone beneath an area of spraying of the defoliant, Orange, the
maximum impingement of 20.2 mg/kg of 2,4,5-T on her skin
might be expected. This should probably be viewed as equivalent
to 2.0 mg/kg of an oral dose.
REFERENCES
(1) AUDUS, L. J. Microbiological breakdown of herbicides in soils. In: Herbi-
cides and the soil. Woodford, E. H., and Sagar, G. R. (Eds.) 1960.
(2) BAUR, J. R., BOVEY, R. W., and SMITH, J. D. Weed Science 17:567, 1969.
(S) BROWN, E. and NISHIOKA, Y. A. Pesticides Monit. J. 1:38, 1967.
(4) COKNELIUSSEN, P. E. Pesticides Monit. J. 2:140,1969.
(5) DUGGAN, R. E., and LIPSCOMB, G. 0. Pesticides Monit. J. 2:153,1969.
(6) EBNE, KURT. Acta vet. scand. 7:240,1966.
(7) ERNE, KURT. Acta vet. scand. 7:264,1966.
(8) HOUSE, W. B., GOODSON, L. H., GADBERRY, H. M., and DOCKTER, K. W.,
Assessment of ecological affects of extensive or repeated use of herbi-
cides. Midwest Research Institute. Project No. 3103-B, December 1967.
(9) HUGHES, J. S. and DAVIS, J. T., Weeds 11:50,1963.
(10) MCNAMARA, B. P. Unpublished observations.
(11) MARIGOLD, DOUGLAS B. and SCHULZE, JEAN A. Pesticides Monit. J. 5:124,
1969.
(IS) MORTON, H. L., ROBINSON, E. D., and MEYER, R. E., Weeds 15:268, 1967.
(IS) NORRIS, LOGAN A. Degradation of several herbicides in red alder forest
floor material. In: Research Progress Report Western Society of Weed
Science, p. 21,1969.
(14) PALMER, J. S., and RADELEFF, R. D. The toxicity of some organic herbi-
cides to cattle, sheep, and chickens. ARS, USDA Production Research
Report No. 106,1969.
(15) TARRANT, R. F., and NORRIS, L. A. Residues of herbicides and diesel oil
carriers in forest water. Proc. Symposium on Herbicides in Vegeta-
tion Management (Oregon State University), p. 81,1967.
(16) TSCHIKLEY, F. S. Response of tropical and subtropical woody plants to
chemical treatments. ARS, USDA Research Report No. CR-13-67,
1968.
(17) WAY, J. G. Residue Rev. 26:37,1969.
[p. 64]
SOME ECOLOGICAL EFFECTS
SUMMARY
Elimination of types of vegetation on which mammals, birds,
fish, and insects and other species depend, can severely reduce or
eliminate them from the treated habitat. However, altering the
vegetation makeup may also benefit certain types of wildlife. The
-------
GUIDELINES AND REPORTS 1563
elimination of water hyacinth from some water bodies, for exam-
ple, has proved a necessity for the survival of sport fishery
programs.
2,4,5-T has been found to affect non-target organisms in a
number of ways:
1. Although chickens, quail and mallard ducks appear to be
relatively resistant to 2,4,5-T, the herbicide has been reported to
reduce egg production in domestic chickens.
2. Some formulations of 2,4,5-T, such as certain esters, have
been found to be quite toxic to fish and oysters.
3. The hydrocyanic acid content of sudan grass was found to
increase 70 percent following treatment with 2,4,5-T. Nitrate
levels in certain plants may increase up to 36 percent following
treatment with 2,4,5-T, making them more toxic to mammals
Increasing the toxicity of plants to wildlife might have important
effects in nature.
5. 2,4,5-T may cause some species of microorganisms to de-
crease in number while having no effect upon other species. In
soil, 2,4,5-T has been found to largely disappear in about three
months.
2,4,5-T has been found to influence non-target organisms both
directly and indirectly through habitat changes. The impact of
2,4,5-T on the principal classes of non-target organisms is pre-
sented in the following sections.
MAMMALS
Roe and Hymas (12) presented data to indicate that the acute
oral toxicity LD50 of 2,4,5-T to various species of mammals was
about 500 mg/kg.
2,4,5-T has some repellent action. When cottontail rabbits
(Sylvilagus florid&nus) were given a choice of either 2,4,5-T
treated vegetation or untreated, the rabbits consumed almost none
of the treated vegetation. (14) r __,
LP- 65]
Applying 2,4,5-T or 2,4,5-T in combination with 2,4-D at
recommended dosages for brush control in Michigan, resulted in
killing the oak type vegetation and released the pine and encour-
aged a dense ground cover of grasses and other herbs, taller berry
producing shrubs, and tree sprouts. (7) The low growing food and
cover were ideal for deer, rabbits, grouse, and other forest animals.
Chemical brush control was carried out in power-line right-of-
way with 2,4-D and 2,4,5-T applications. Woody brush was prac-
-------
1564 LEGAL COMPILATION—PESTICIDES
tically eliminated. White-tail deer (Odocoileits virginianus) have
used both the treated and untreated areas and their use of both
areas increased during the four years of investigation. (2) The
deer made less use of the treated areas during the winter months
because there was less food available. The deer fed most heavily
in the treated areas in the spring and early summer on various
grasses and herbs. Deer also bedded down in the treated areas in
patches of sedge and grass. Numbers of cottontail rabbits were
found to increase in the treated areas because of improved food
and cover.
BIRDS
Fifty percent mortality in birds occurred for the following doses
(2,4,5-T fed in the daily diet for less than 10 days): 5,000 ppm
for young bobwhite quail (Colinus virginianus); 5,000 ppm for
young mallard ducks (Anas platyrhynchos). (4) Approximate
LD50's based on estimated food consumption, were: 9,000 mg/kg
for the bobwhite; 21,000 mg/kg for the mallard.
The use of 2,4,5-T and 2,4-D for brush control under power
lines improved the environment for ruffed grouse (Bonasa umbel-
lus) (2). The grouse were found on the edges within 150-200 feet
of the right-of-way rather than on the right-of-way itself. This
emphasized the importance of the right-of-way as a creator of
edge effects. Wild turkeys (Meleagris gallopavo) were also ob-
served to make effective use of the rights-of-way treated areas.
The young turkeys were attracted to the openings for feeding on
various insects which were more abundant on the grassy right-of-
way than within the wooded areas.
Chickens were exposed daily for 14 days to grass treated with
2,4,5-T (15 percent active agent) at % oz/gal of water and 2!/2
oz/gal. (5) The low 2,4,5-T treatment led to a 9 percent reduction
in egg yield and the higher dosage to an 18 percent reduction but
there was no change in the fertility or hatchability of the eggs.
The exposed chickens also lost some weight.
FISH
The 24-hour LC50* for rainbow trout (Salmo gairdnerii) ex-
posed to 2,4,5-T was 12 ppm; however, Bohmont (1) reported a
48-hour LC50 [p 66]
for rainbow trout at 1.3 ppm. Bohmont also calculated the
48-hour LC50 for bluegills (Lepomis macrochirus) to be 0.50 ppm.
* LCso, median lethal concentration of a toxicant which kills 60 percent of the test organisms.
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GUIDELINES AND REPORTS 1565
Young silver salmon (Oncorhynchus kisutch) exposed to a com-
bination of 2,4,5-T and 2,4-D (about 10 percent of each chemical
in the formulation) at concentrations of 50 ppm or more were
observed to be "immediately distressed and would snap their jaws,
dart about the aquarium, and leap out of the water before loss of
equilibrium and death." (8)
Mullet (Mugil cephaius) exposed to 50 ppm of 2,4,5-T for 48
hours exhibited no noticeable effects. (3)
Table 1 gives 24- and 48-hour LC50's of bluegill sunfish to various
2,4,5-T formulation. (9) The esters appeared to be most toxic,
probably due to better solubility. No attempt was made by Hughes
and Davis to explain the wide variation in results obtained from
different batches of the same formulation.
TABLE l.-THE LCso OF BLUEGILL SUNFISH TO 2,4,5-T FORMULATIONS. (9)
Dimethylamine
Isooctyl ester*
Isooctyl ester*
Isooctyl ester* .
Propylene glycol butyl ethyl ester
Butoxyetnanol ester
24-hour
144
31
- - 28
_ 10.4
17
1 4
48-hour
144
31
26
10.4
17
1.4
•Different batches of the same formulation.
MOLLUSCS
The exposure of oysters (Crassostrea virginica) to 2.0 ppm of
2,4,5-T acid for 96 hours had no effect on shell growth. (3)
INVERTEBRATES
The minimum lethal dosages (ppm) which produced a kill ex-
ceeding 25 percent with 2,4,5-T are listed for the following fish
food organisms: Daphnia 1.5; Eucypris 0.5; Hyallella 0.7; Palae-
monetes 1.2; Amphiagrion 7.5; Pachydiplax and Tramea 8.0; and
Chironomus 6.0. (16)
The exposure of brown shrimp (Penaeus aztecus) to 1.0 ppm of
2,4,5-T for 48 hours had no noticeable effects. (3)
PLANTS
Swanson and Shaw (15) demonstrated that the hydrocyanic
acid content of sudan grass was increased by 70 percent in plots
treated with 1 Ib/acre of 2,4,5-T.
When 9 species of weeds were treated with sublethal dosages
(0.25 Ib/acre of 2,4,5-T, the nitrate content of the plants de-
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1566 LEGAL COMPILATION—PESTICIDES
creased from 5 to 32 percent in 4 species but increased from 3 to
36 percent [p 67]
in the other species. (6) The 36 percent increase occurred in
Impatiens biflora.
The exposure of phytoplankton to 1.0 ppm of 2,4,5-T for 4 hours
caused no decrease in growth. (3)
MICROORGANISMS
Magee and Colmer (11) reported that 2,4,5-T at 1,500 to 2,000
ppm produced inhibition of respiration to Azotobacter, however,
2,4,5-T was found not to affect Streptomyces at 2 and 50 Ib/acre.
PERSISTENCE
2,4,5-T applied at a rate of Va to 3 Ib/acre was found to persist
for 2 to 5 weeks with little or no leaching, under summertime
conditions in a temperate climate and moist loam soil. (10)
Sheets and Harris (13), however, reported that 2,4,5-T generally
persisted for about 3 months under moist soil conditions.
REFERENCES
(1) BOHMONT, B. L., Proc., 20th Western Weed Control Conf., 21:25, 1967.
(8) BRAMBLE, W. C. and BYRNES, W. E., Pa. Game News 29-.V1,1958.
(8) BUTLER, P. A., U.S. Dep. Interior, Fish Wildlife Serv. Circ. 167:11, 1963.
(4) DEWITT, J. B., STICKEL, W. H., and SPRINGER, P. F., Wildlife studies,
Patuxent Wildlife Research Center 1961-62. In Pesticide wildlife
studies. U.S. Fish Wildlife Serv. Circ. 167:74,1963.
(5) DOBSON, N., J. Ministry of Agriculture (Britain), 110:415,1954.
(6) FRANK, P. A. and GRIGSBY, B. H., Weeds, 5:206,1957.
(7) GYSELL, L. W., Down to Earth 2,1957.
(8) HOLLAND, G. A., LASATER, J. E., NEUMANN, E. D., and W. E. ELDRIDGE.
Toxic effects of organic and inorganic pollutants on young salmon
and trout. Wash. Dept. Fish. Res. Bull., 5,1960.
(9) HUGHES, J. S. and DAVIS, J. T., Weeds 11:50,1963.
(10) KLINGMAN, T. C., Weed control as a science. John Wiley and Sons, Inc.,
New York, 1961.
(11) MAGEE, L. A. and COLMER, A. R., Appl. Microbiol. 3:288,1955.
(12) EOWE, V. K. and HYMAS, T. A., Amer. J. of Vet. Res. IS :622,1954.
(IS) SHEETS, D. J. and HARRIS, C. I., Herbicide residues in soils and their
vital toxicities to crops grown in rotations, pp. 119-140 from Residue
Reviews, 11, F. A. Gunther (Editor), Springer-Verlag, New York,
Inc., 1965.
(14) SPRINGER, P. F., North Carolina, Pesticide Manual, 1957.
(15) SWANSON, C. R. and SHAW, W. C., Agron. J. 45:418,1954.
(16) ZISCHKALE, M., Field & Lab., 20:18,1952. [p. 68]
US Environmental Protection Agaw%vERB_,™ <,,,,,,
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