THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
Statutes and Legislative Historv
Executive Orders
Regulations
Guidelines and Reports
5
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THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
Statutes and Legislative History
Executive Orders
Regulations
Guidelines and Reports
2EZ
Ul
u
JANUARY 1973
WILLIAM D. RUCKELSHAUS
Administrator
U.S. Environmental Protection Agency
Region V, Library
230 South Dearborn Street
Chicago, Illinois 60604- , ,
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For sale by the Superintendent of Documents, U.S. Government Printing Office
Washington, D.C. 20402 - Price: $7.25 per 3 vol. set. Sold in sets only
Stock Number 5500-0069
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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 O. 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)(D.
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 (8.1, 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, Defoliant 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.*! _____ 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, 1960,
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
1.2j 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
-------
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.E. 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
-------
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 Kecord, 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.llfo 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 Food, 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
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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 Pood, 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
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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
l.lSh 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
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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, §§2353, 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
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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-l 15d(3) (c)" for 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
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xxxii CONTENTS
Page
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 Governing1 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 Depart-
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
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STATUTES AND LEGISLATIVE HISTORY 529
1.2c 1940 REORGANIZATION PLAN NO. 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]
1.2d 1953 REORGANIZATION PLAN NO. I, §§5, 8, 67 STAT. 632
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 reorganization
plan), the offices of Federal Security Administrator and Assistant
Federal Security Administrator created by Reorganization Plan
No. I (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 Secretary shall
make such provisions as may be necessary in order to wind up any
outstanding affairs of the Agency and offices abolished by this sec-
tion which are not otherwise provided for in this reorganization
plan.
[p. 632]
1.2e FOOD ADDITIVES AMENDMENTS OF 1958
September 6,1958, P.L. 85-929, §§3(c), 4, 6(a), 72 Stat. 1784
AN ACT
To protect the public health by amending the Federal Food, Drug, and Cosmetic
Act to prohibit the use in food of additives which have not been adequately
tested to establish their safety.
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530 LEGAL COMPILATION—PESTICIDES
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, That this Act may
be cited as the "Food Additives Amendment of 1958".
SEC. 2. Section 201, as amended, of the Federal Food, Drug, and
Cosmetic Act is further amended by adding at the end of such
section the following new paragraphs:
"(s) The term 'food additive' means any substance 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 (including any substance
intended for use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food; and
including any source of radiation intended for any such use), if
such substance is not generally recognized, among experts qualified
by scientific training and experience to evaluate its safety, as
having been adequately shown through scientific procedures (or,
in the case of a substance used in food prior to January 1, 1958,
through either scientific procedures or experience based on com-
mon use in food) to be safe under the conditions of its intended
use; except that such term does not include—
"(1) a pesticide chemical in or on a raw agricultural com-
modity ; or
"(2) a pesticide chemical to the extent that it is intended
for use or is used in the production, storage, or transportation
of any raw agricultural commodity; or
"(3) any substance used in accordance with a sanction or
approval granted prior to the enactment of this paragraph
pursuant to this Act, The Poultry Products Inspection Act
(21 U.S.C. 451 and the following) or the Meat Inspection Act
of March 4, 1907 (34 Stat. 1260), as amended and extended
(21 U.S.C. 71 and the following).
"(t) The term 'safe', as used in paragraph (s) of this section
and in section 409, has reference to the health of man or animal."
SEC. 3. (a) Clause (2) of section 402 (a), as amended, of such
Act is amended to read as follows: " (2) (A) if it bears or contains
any added poisonous or added deleterious substance (except a pesti-
cide chemical in or on a raw agricultural commodity and except a
food additive) which is unsafe within the meaning of section 406,
or (B) if it is a raw agricultural commodity and it bears or con-
tains a pesticide chemical which is unsafe within the meaning of
section 408 (a), or (C) if it is, or it bears or contains, any food
additive which is unsafe within the meaning of section 409:
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STATUTES AND LEGISLATIVE HISTORY 531
Provided, That where a pesticide chemical has been used in or on
a raw agricultural commodity in conformity with an exemption
granted or a tolerance prescribed under section 408 and such raw
agricultural commodity has been subjected to processing such as
canning, cooking, freezing, dehydrating, or milling, the residue
of such pesticide chemical remaining in or on such processed food
shall, notwithstanding the provisions of sections 406 and 409, not
be deemed unsafe if such residue in or on the raw agricultural
commodity has been removed to the extent possible in good manu-
facturing practice and the concentration of such residue in the
processed food when ready to eat is not greater than the tolerance
prescribed for the raw agricultural commodity;".
[p. 1784]
(b) Section 402 (a), as amended, of such Act is further
amended by striking out the period at the end thereof and inserting
in lieu thereof a semicolon and the following: "or (7) if it has been
intentionally subjected to radiation, unless the use of the radiation
was in conformity with a regulation or exemption in effect pursu-
ant to section 409."
(c) The first sentence of section 406 (a) of such Act is amended
by striking out "clause (2)" wherever it appears in such sentence
and inserting in lieu thereof "clause (2) (A)".
SEC. 4. Chapter IV of such Act is amended by adding at the end
thereof the following new section:
"FOOD ADDITIVES
"Unsafe Food Additives
SEC. 409. (a) A food additive shall, with respect to any particu-
lar use or intended use of such additives, be deemed to be unsafe
for the purposes of the application of clause (2) (C) of section
402 (a), unless—
"(1) it and its use or intended use conform to the terms of
an exemption which is in effect pursuant to subsection (i) of
this section; or
" (2) there is in effect, and it and its use or intended use are
in conformity with, a regulation issued under this section
prescribing the conditions under which such additive may be
safely used.
While such a regulation relating to a food additive is in effect, a
food shall not, by reason of bearing or containing such an additive
in accordance with the regulation, be considered adulterated within
the meaning of clause (1) of section 402 (a).
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532 LEGAL COMPILATION—PESTICIDES
"Petition To Establish Safety
" (b) (1) Any person may, with respect to any intended use of a
food additive, file with the Secretary a petition proposing the
issuance of a regulation prescribing the conditions under which
such additive may be safely used.
"(2) Such petition shall, in addition to any explanatory or sup-
porting data, contain—
"(A) the name and all pertinent information concerning
such food additive, including, where available, its chemical
identity and composition;
"(B) a statement of the conditions of the proposed use of
such additive, including all directions, recommendations, and
suggestions proposed for the use of such additive, and includ-
ing specimens of its proposed labeling;
"(C) all relevant data bearing on the physical or other
technical effects such additive is intended to produce, and the
quantity of such additive required to produce such effect;
"(D) a description of practicable methods for determining
the quantity of such additive in or on food, and any substance
formed in or on food, because of its use; and
" (E) full reports of investigations made with respect to the
safety for use of such additive, including full information as
to the methods and controls used in conducting such inves-
tigations.
"(3) Upon request of the Secretary, the petitioner shall furnish
(or, if the petitioner is not the manufacturer of such additive, the
petitioner shall have the manufacturer of such additive furnish,
[p. 1785]
without disclosure to the petitioner) a full description of the
methods used in, and the facilities and controls used for, the pro-
duction of such additive.
"(4) Upon request of the Secretary, the petitioner shall furnish
samples of the food additive involved, or articles used as compo-
nents thereof, and of the food in or on which the additive is pro-
posed to be used.
"(5) Notice of the regulation proposed by the petitioner shall be
published in general terms by the Secretary within thirty days
after filing.
"Action on the Petition
"(c) (1) The Secretary shall—
" (A) by order establish a regulation (whether or not in
accord with that proposed by the petitioner) prescribing, with
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STATUTES AND LEGISLATIVE HISTORY 533
respect to one or more proposed uses of the food additive
involved, the conditions under which such additive may be
safely used (including, but not limited to, specifications as to
the particular food or classes of food in or in which such
additive may be used, the maximum quantity which may be
used or permitted to remain in or on such food, the manner
in which such additive may be added to or used in or on such
food, and any directions or other labeling or packaging
requirements for such additive deemed necessary by him to
assure the safety of such use), and shall notify the petitioner
of such order and the reason for such action; or
"(B) by order deny the petition, and shall notify the peti-
tioner of such order and of the reasons for such action.
"(2) The order required by paragraph (1) (A) or (B) of this
subsection shall be issued within ninety days after the date of
filing of the petition, except that the Secretary may (prior to such
ninetieth day), by written notice to the petitioner, extend such
ninety-day period to such time (not more than one hundred and
eighty days after the date of filing of the petition) as the Secretary
deems necessary to enable him to study and investigate the peti-
tion.
"(3) No such regulation shall issue if a fair evaluation of the
data before the Secretary—
"(A) fails to establish that the proposed use of the food
additive, under the conditions of use to be specified in the
regulation, will be safe; Provided, That no additive shall be
deemed to be safe if it is found to induce cancer when ingested
by man or animal, or if it is found, after tests which are
appropriate for the evaluation of the safety of food additives,
to induce cancer in man or animal; or
"(B) shows that the proposed use of the additive would
promote deception of the consumer in violation of this Act or
would otherwise result in adulteration or in misbranding of
food within the meaning of this Act.
"(4) If, in the judgment of the Secretary, based upon a fair
evaluation of the data before him, a tolerance limitation is required
in order to assure that the proposed use of an additive will be safe,
the Secretary—
"(A) shall not fix such tolerance limitation at a level
higher than he finds to be reasonably required to accomplish
the physical or other technical effect for which such additive is
intended; and
"(B) shall not establish a regulation for such proposed use
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534 LEGAL COMPILATION—PESTICIDES
if he finds upon a fair evaluation of the data before him that
such data do not establish that such use would accomplish
the intended physical or other technical effect.
[p.1786]
"(5) In determining for the purposes of this section, whether
a proposed use of a food additive is safe, the Secretary shall con-
sider among other relevant factors—
" (A) the probable consumption of the additive and of any
substance formed in or on food because of the use of the addi-
tive;
"(B) the cumulative effect of such additive in the diet of
man or animals, taking into account any chemically or phar-
macologically related substance or substances in such diet; and
"(C) safety factors which in the opinion of experts quali-
fied by scientific training and experience to evaluate the
safety of food additives are generally recognized as appro-
priate for the use of animal experimentation data.
"Regulation Issued on Secretary's Initiative
"(d) The Secretary may at any time, upon his own initiative,
propose the issuance of a regulation prescribing, with respect to
any particular use of a food additive, the conditions under which
such additive may be safely used, and the reasons therefor. After
the thirtieth day following publication of such a proposal, the Sec-
retary may by order establish a regulation based upon the proposal.
"Publication and Effective Date of Orders
"(e) Any order, including any regulation established by such
order, issued under subsection (c) or (d) of this section, shall be
published and shall be effective upon publication, but the Secretary
may stay such effectiveness if, after issuance of such order, a
hearing is sought with respect to such order pursuant to subsec-
tion (f).
"Objections and Public Hearing
" (f) (1) Within thirty days after publication of an order made
pursuant to subsection (c) or (d) of this section, any person
adversely affected by such an order may file objections thereto with
the Secretary, specifying with particularity the provisions of the
order deemed objectionable, stating reasonable grounds therefor,
and requesting a public hearing upon such objections. The Secre-
tary, shall, after due notice, as promptly as possible hold such
public hearing for the purpose of receiving evidence relevant and
material to the issues raised by such objections. As soon as practi-
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STATUTES AND LEGISLATIVE HISTORY 535
cable after completion of the hearing, the Secretary shall by order
act upon such objections and make such order public.
"(2) Such order shall be based upon a fair evaluation of the
entire record at such hearing, and shall include a statement setting
forth in detail the findings and conclusions upon which the order
is based.
"(3) 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 Secre-
tary 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.
"Judicial Review
" (g) (1) In a case of actual controversy as to the validity of any
order issued under subsection (f), including any order thereunder
with respect to amendment or repeal of a regulation issued under
this section, any person who will be adversely affected by such
order may obtain judicial review by filing in the United States
Court of Appeals for the circuit wherein such person resides or
has his principal place of business, or in the United States Court
[p.1787]
of Appeals for the District of Columbia Circuit, within sixty days
after the entry of such order, a petition praying that the order
be set aside in whole or in part.
"(2) A copy of such petition shall be forthwith served upon the
Secretary, or upon any officer designated by him for that purpose,
and thereupon the Secretary shall certify and file in the court a
transcript of the proceedings and the record on which he based
his order. Upon such filing, the court shall have exclusive jurisdic-
tion to affirm or set aside the order complained of in whole or in
part. The findings of the Secretary with respect to questions of fact
shall be sustained if based upon a fair evaluation of the entire
record at such hearing. The court shall advance on the docket and
expedite the disposition of all causes filed therein pursuant to this
section.
"(3) The court, on such judicial review, shall not sustain the
order of the Secretary if he failed to comply with any requirement
imposed on him by subsection (f) (2) of this section.
" (4) If application is made to the court for leave to adduce addi-
tional evidence, the court may order such additional evidence 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
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536 LEGAL COMPILATION—PESTICIDES
may seem proper, if such evidence is material and there were rea-
sonable grounds for failure to adduce such evidence in the proceed-
ings below. The Secretary may modify his findings as to the facts
and order by reason of the additional evidence so taken, and shall
file with the court such modified findings and order.
"(5) The judgment of the court affirming or setting aside, in
whole or in part, any order under this section shall be final, subject
to review by the Supreme Court of the United States upon certio-
rari or certification as provided in section 1254 of title 28 of the
United States Code. The commencement of proceedings under this
section shall not, unless specifically ordered by the court to the
contrary, operate as a stay of an order.
"Amendment or Repeal of Regulations
"(h) The Secretary shall by regulation prescribe the procedure
by which regulations under the foregoing provisions of this sec-
tion may be amended or repealed, and such procedure shall
conform to the procedure provided in this section for the promul-
gation of such regulations.
"Exemptions for Investigational Use
"(i) Without regard to subsection (b) to (h), inclusive, of this
section, the Secretary shall by regulation provide for exempting
from the requirements of this section any food additive, and any
food bearing or containing such additive, intended solely for inves-
tigational use by qualified experts when in his opinion such exemp-
tion is consistent with the public health."
SEC. 5. Section 301 (j) of such Act is amended by inserting
"409," after "404,".
SEC. 6. (a) Except as provided in subsections (b) and (c) of
this section, this Act shall take effect on the date of its enactment.
(b) Except as provided in subsection (c) of this section, section
3 of this Act shall take effect on the one hundred and eightieth day
after the date of enactment of this Act.
(c) With respect to any particular commercial use of a food
additive, if such use was made of such additive before January 1,
1958, section 3 of this Act shall take effect—
(1) either (A) one year after the effective date established
in subsection (b) of this section, or (B) at the end of such
additional period (but not later than two years from such
effective date established in subsection (b) as the Secretary
of Health, Education, and Welfare may prescribe on the basis
of a finding that such extension involves no undue risk to the
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STATUTES AND LEGISLATIVE HISTORY 537
public health and that conditions exist which necessitate the
prescribing of such an additional period, or
(2) on the date on which an order with respect to such use
under section 409 of the Federal Food, Drug, and Cosmetic
Act becomes effective.
whichever date first occurs.
SEC. 7. Nothing in this Act shall be construed to exempt any
meat or meat food product or any person from any requirement
imposed by or pursuant to the Poultry Products Inspection Act.
(21 U. S. C. 451 and the following) or the Meat Inspection Act of
March 4,1907, 34 Stat. 1260, as amended and extended (21 U. S. C.
71 and the following).
[p. 1788]
SEC. 8. The annual rate of basic compensation of the Commis-
sioner of Food and Drugs shall be $20,000.
SEC. 9. Section 208 (g) of the Public Health Service Act,
as amended (42 U. S. C. 210 (g) ), is amended by striking out the
phrase "in the professional and scientific service" and inserting
in lieu thereof the phrase "in the professional, scientific, and execu-
tive service" and by striking out the phrase "of specially qualified
scientific or professional personnel" and inserting in lieu thereof
"of specially qualified scientific, professional, and administrative
personnel."
Approved September 6,1958.
[p. 1789]
1.2e (1) HOUSE COMMITTEE ON INTERSTATE AND FOR-
EIGN COMMERCE
H.R. REP. No. 2284, 85th Cong., 2d Sess. (1958)
FOOD ADDITIVES AMENDMENT OF 1958
JULY 28, 1958.—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. 13254]
The Committee on Interstate and Foreign Commerce, to whom
was referred the bill (H. R. 13254) to protect the public health by
amending the Federal Food, Drug, and Cosmetic Act to prohibit
the use in food of additives which have not been adequately tested
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538 LEGAL COMPILATION—PESTICIDES
to establish their safety, having considered the same, report favor-
ably thereon with an amendment and recommend that the bill, as
amended, do pass.
The amendment is as follows:
The amendment strikes all of the text of the introduced bill and
inserts in lieu thereof a substitute which appears in the reported
bill in italic type.
PURPOSE OF LEGISLATION
The purpose of the legislation is twofold:
(1) To protect the health of consumers by requiring manufac-
turers of food additives and food processors to pretest any poten-
tially unsafe substances which are to be added to food; and (2)
to advance food technology by permitting the use of food additives
at safe levels.
Existing law bars the use, even at safe levels, of additives which
are poisonous or deleterious unless their use is required in produc-
tion or cannot be avoided by good manufacturing practice. The
Federal Government in order to prevent the use of an additive
must prove that it is a poisonous or deleterious substance. The law
thus gives rise to a dual problem. On the one hand, to prove an
untested substance poisonous or deleterious may require approxi-
mately 2 years or more of laboratory experiments with small
animals and during this period the Government cannot prevent the
use of such a substance in food. On the other hand, present law
entirely prohibits the use of these additives even if their use at
[P.I]
safe levels would advance our food technology and increase and
improve our food supplies.
The Food and Drug Administration has pointed out the dangers
to the public health resulting from the failure of the present law
to require pretesting of food additives. On the other hand that
agency agrees that the present law should be changed to permit the
use of additives at safe levels in order to advance our food tech-
nology.
While the responsible elements of the affected industries tradi-
tionally have voluntarily undertaken to pretest food additives they
are willing to assume this responsibility under a statutory man-
date. Thus, those elements of the industry which in the past have
used harmful additives or additives of unknown toxicity without
pretesting will in the future under this legislation be required to
assume the same duties as the responsible elements have hereto-
fore voluntarily assumed.
Although there has been complete agreement as to the need for
-------
STATUTES AND LEGISLATIVE HISTORY 539
this legislation, there have been differencs between the Food and
Drug Administration and the affected industries with respect to
procedures to be followed in determining the safety of an additive
and the method of judicial review of such a determination. With
respect to these controversial procedural questions, the committee
feels the proposed legislation steers a course which satisfies both
the need for protecting the public health and the legitimate inter-
ests of industry and Government in fair procedures.
HISTORY OF LEGISLATION
During the 81st Congress, a Select Committee to Investigate the
Use of Chemicals in Foods and Cosmetics (better known as the
Delaney committee, named after its chairman, Congressman James
J. Delaney) was created in the House of Representatives to study
the need to amend the present Federal Food, Drug, and Cosmetic
Act in this respect. After extended hearings, the committee on
June 30, 1952, filed a report (H. Kept. No. 2356, 82d Cong., 2d
sess.) urging amending the present law so that chemicals employed
in or on foods would be subjected to substantially the same safety
requirements as exist in the law for new drugs.
Bills to accomplish the objectives of the report were introduced
by Congressman Delaney and referred to this committee during
the 83d Congress and subsequent Congresses, and other Members
of Congress introduced numerous bills differing from the proto-
type bills primarily with respect to agency procedure and judicial
review.
During the 83d Congress, the committee held hearings and
reported favorably related legislation providing for the pretesting
of, and the establishment of safe tolerances for, pesticide chemi-
cals. This bill was enacted into law (Public Law 518, 83d Cong.).
During the 2d session of the 84th Congress, the Subcommittee
on Health and Science, under the chairmanship of the late full
committee chairman, J. Percy Priest, held 5 days of hearings on
10 bills dealing with chemical additives in and on food. The hearings
indicated basic agreement with regard to the need for chemical
additive legislation, but also considerable disagreement with regard
to the agency and judicial review procedures to be followed in
determining the safety of chemical additives. This disagreement
was not resolved, and no chemical additive legislation was enacted
during the 84th Congress.
[p. 2]
During the 85th Congress, the Subcommittee on Health and
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540 LEGAL COMPILATION—PESTICIDES
Science held 11 days of hearings on 9 bills.1 The hearings included
2 days of testimony by a panel of outstanding scientists and experts
selected by the National Academy of Sciences at the request of the
subcommittee, to give the subcommittee the scientific background
with regard to the testing and evaluating of the safety of chemical
additives. The subcommittee also heard witnesses from industry,
labor, and consumer organizations, representatives from the
Department of Health, Education, and Welfare, including those
from the Food and Drug Administration, and the chief judge of
the third judicial circuit appearing on behalf of the Judicial Con-
ference of the United States.
As a result of the hearings and after consideration of the various
bills, the chairman of the subcommittee, Congressman John Bell
Williams of Mississippi, introduced a clean bill (H. R. 13254)
which was reported unanimously by the subcommittee to the full
committee.
The full committee unanimously reported the bill with one
amendment which strikes out all after the enacting clause and
inserts in place of the introduced bill a substitute. The principal
difference between the proposed committee amendment and the
introduced bill is the elimination of the provisions in the introduced
bill relating to scientific advisory committees. The remaining differ-
ences are the result of clerical, technical, and clarifying changes.
PRINCIPAL PROVISIONS OF LEGISLATION
Substances covered by legislation
Pretesting is required under this legislation only with respect to
those food additives which are not generally recognized among
competent experts as having been adequately shown to be safe
under the conditions of their intended use. An additive may be
shown to be safe either by means of scientific procedures (includ-
ing a review of the existing scientific literature) or, in the case of
substances in use prior to January 1, 1958, also by means of expe-
rience based on common use in food.
The legislation covers substances which are added intentionally
to food. These additives are generally referred to as "intentional
additives."
The legislation also covers substances which may reasonably be
expected to become a component of any food or to affect the charac-
1H.R. 366 (O'Hara of Minnesota), H.R. 6747 (Harris), H.R. 7700 (Fulton), H.R. 7708
(Delaney) H.R. 7938 (Sullivan), H.R. 8390 (Harris), H.R. 8629 (Wolverton), H.R. 8112
(Miller), and H.R. 10404, (Williams of Mississippi).
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STATUTES AND LEGISLATIVE HISTORY 541
teristics of any food. These substances are generally referred to as
"incidental additives."
The principal examples of both intentional and incidental addi-
tives are substances intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, transporting,
or holding food.
On the other hand, substances which may accidentally get into a
food, as for example, paints or cleaning solutions used in food
processing plants, are not covered by the legislation. These addi-
tives are generally referred to as "accidental additives," since these
substances if properly used may not reasonably be expected to
become a component of a food or otherwise to affect the character-
istics of a food. If accidental additives do get into food, the provi-
sions of the Food, Drug, and Cosmetic Act dealing with poisonous
[p. 3]
and deleterious substances would be applicable.
Sources of radiation (including radioactive isotopes, particle
accelerators and X-ray machines) intended for use in processing
food are included in the .term "food additive" as defined in this
legislation.
Exempted from the scope of the legislation are (1) pesticide
chemicals in or on raw agricultural commodities which are already
covered by the pesticide chemicals amendment to the Federal Food,
Drug, and Cosmetic Act (Public Law 518, 83d Cong.) ; (2) resi-
dues of pesticide chemicals unavoidably remaining on processed
foods not in excess of tolerances prescribed by Food and Drug
Administration for raw agricultural commodities; and (3) sub-
stances already approved under the provisions of the Federal
Food, Drug, and Cosmetic Act or the Meat Inspection Act of
March 4, 1907.
The Secretary is given authority by this legislation to exempt by
regulation food additives for investigational use by qualified
experts when consistent with the public health.
Regulation to establish safety
A regulation prescribing the conditions under which an additive
may be safely used may be issued by the Secretary of Health, Edu-
cation, and Welfare either on the basis of a petition filed by any
person (ordinarily the manufacturer of the additive) or on the
Secretary's own initiative.
The petition would set forth the name and all pertinent infor-
mation concerning the additive, including, where available, its
chemical identity and composition; full reports of scientific inves-
tigations of safety for use; the conditions of the proposed use of
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542 LEGAL COMPILATION—PESTICIDES
such additive; relevant data bearing on the physical or other tech-
nical effect such additive is intended to produce; the quantity
required to produce such effect; when requested by the Secretary,
the methods used to produce the additive; and a description of
practical methods to determine the quantity of such additive left
in or on food because of its use.
Trade secrets supplied to the Secretary would be protected under
this legislation from unauthorized disclosure by departmental per-
sonnel.
The Secretary would either, by order, establish a regulation pre-
scribing the conditions under which such additive may be safely
used, or he would, by order, deny the petition and notify the peti-
tioner of the reasons for such action. Such orders would be issued
•within 90 days after the date of filing of the petition unless the
Secretary, by written notice to the petitioner, extends such period
for not more than an additional 90 days to enable him to study the
petition.
Concept of safety
The concept of safety used in this legislation involves the ques-
tion of whether a substance is hazardous to the health of man or
animal. Safety requires proof of a reasonable certainty that no
harm will result from the proposed use of an additive. It does not—
and cannot—require proof beyond any possible doubt that no harm
will result under any conceivable circumstance.
This was emphasized particularly by the scientific panel which
testified before the subcommittee. The scientists pointed out that
[p-4]
it is impossible in the present state of scientific knowledge to estab-
lish with complete certainty the absolute harmlessness of any
chemical substance.
In determining the "safety" of an additive, scientists must take
into consideration the cumulative effect of such additive in the diet
of man or animals over their respective life spans together with
any chemically or pharmacologically related substances in such
diet. Thus, the safety of a given additive involves informed judg-
ments based on educated estimates by scientists and experts of the
anticipated ingestion of an additive by man and animals under
likely patterns of use.
Reasonable certainty determined in this fashion that an additive
will be safe, will protect the public health from harm and will per-
mit sound progress in food technology.
The legislation adopts this concept of safety by requiring the
Secretary to consider in addition to information with regard to the
-------
STATUTES AND LEGISLATIVE HISTORY 543
specific additive in question, among others, the following relevant
factors: (1) the probable consumption of the additive and of any
substance formed in or on food because of the use of such additive;
(2) the cumulative effect of such additive in the diet of man or
animals, taking into account any chemically or pharmacologically
related substances in such diet; and (3) safety factors which quali-
fied experts consider appropriate for the use of animal experimen-
tation data.
In determining the safety of an additive, the Secretary would
have to consider not only the food to which the additive is directly
added, but also other foods derived from such foods. For example,
in evaluating the safety of an additive for poultry feed, the Secre-
tary would have to consider any residues that might appear in eggs
produced by the poultry. Similarly, in determining the safety of
additive-treated cattle feed, account would have to be taken of resi-
dues of the additive in the milk or edible flesh of the animal.
Since the scientific investigation and the other relevant data to
be taken into consideration by the Secretary include information
with respect to possible cancer causing characteristics of a pro-
posed additive, the public will be protected from possible harm on
this count.
Grounds for denial of petition
The Secretary would deny a petition to establish the safety of
an additive if the data before the Secretary fail to establish that
the proposed use of the additive under the specified conditions of
use will be safe.
The Secretary could also deny a petition on the ground that the
proposed use of the additive would promote deception of the con-
sumer in violation of the Food and Drug Act or would otherwise
result in adulteration or in misbranding of food within the mean-
ing of the Food and Drug Act.
Tolerance limitations
In the case of an additive which in the judgment of the Secre-
tary based upon a fair evaluation of the data before him, requires
a tolerance limitation in order to assure that the proposed use of
such additive will be safe, the legislation establishes two standards:
(1) the Secretary may not fix such tolerance limitation at a level
higher than he finds to be reasonably required to accomplish the
physical or other technical effect for which such additive is
intended; and
[p. 5]
(2) the Secretary may not establish a regulation for such pro-
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544 LEGAL COMPILATION—PESTICIDES
posed use if he finds upon a fair evaluation of the data before him
that such data do not establish that such use would accomplish the
intended physical or other technical effect.
The phrase "physical or other technical effect" refers to the
objective effect which the additive may have on the appearance,
flavor, texture, or other aspects of a food. The question of whether
an additive produces such effect (or how much of an additive is
required for such effect) is a factual one, and does not involve any
judgment on the part of the Secretary of whether such effect results
in any added "value" to the consumer of such food or enhances the
marketability from a merchandising point of view.
Advisory committees
The committee has deleted the advisory committee procedure
from the bill because there does not appear to be any need for this
complicated mechanism for securing the views of scientists. The
Department already has the privilege of making inquiry of com-
petent outside scientists on technical matters.
Public hearings
Any person adversely affected by an order of the Secretary may
file objections thereto and request a public hearing. At such hear-
ings the Secretary would receive evidence relevant and material to
the issues raised and would by order act upon such objections.
Judicial review
The committee has given long and careful thought to the prob-
lem of the scope of judicial review under this legislation. This
problem was discussed exhaustively by several witnesses, includ-
ing a Federal judge who testified on behalf of the Judicial Confer-
ence of the United States.
The committee feels that the Secretary's findings of fact and
orders should not be based on isolated evidence in the record, which
evidence in and of itself may be considered substantial without
taking account of contradictory evidence of possible equal or even
greater substance.
In the course of scientific panel hearings, the subcommittee
was impressed with the wide range of scientific judgment factors
which are involved in determining the safety of a food additive.
Considering the eminent qualifications of all the scientists and
experts who participated in these panel hearings, the scientific tes-
timony of any one of the participants must be considered "substan-
tial evidence." Nevertheless, any conclusions based solely on the
scientific judgment of any one of the participants without taking
account of contradictory scientific views expressed by other par-
-------
STATUTES AND LEGISLATIVE HISTORY 545
ticipants cannot be considered conclusions based upon a fair evalu-
ation of the entire record.
Thus, under this legislation, the Secretary's findings of fact and
orders based thereon must be based upon a fair evaluation of the
entire record. The committee adopted the language "fair evalua-
tion of the entire record" because it seemed to express most clearly
the standard of judicial review of administrative findings of fact
and orders based thereon which the committee feels should prevail.
The bill provides that the reviewing court shall not sustain the
order of the Secretary if he failed to base such order upon a fair
evaluation of the entire record at such hearing, or if he failed to
include in such order a statement setting forth in detail the findings
[p. 6]
and conclusions upon which the order is based. The court must
sustain the findings of the Secretary with respect to questions of
fact if based upon a fair evaluation of the entire record.
Judicial review of any order of the Secretary under this legisla-
tion may be obtained in the United States court of appeals for the
circuit wherein appellant resides, or has his principal place of busi-
ness, or in the United States Court of Appeals for the District of
Columbia.
Effective date
This legislation will, except as hereinafter stated, take effect on
the date on which it is enacted. Thus the Food and Drug Adminis-
tration can immediately begin making determinations as to the
safety of food additives.
However, since it will take a certain amount of time to make
these determinations of safety, the provisions of section 3 of the
legislation (which will have the effect of permitting seizure, injunc-
tion suits, and criminal prosecutions on account of the shipment
in interstate commerce of an additive, or food containing an addi-
tive, which has not been determined to be safe) will not take effect
until 180 days after the enactment of this legislation.
A further exception is made in the case of any particular com-
mercial use of a food additive if such use began before January 1,
1958. In the case of such use, section 3 would take effect either on
the establishment of an order with respect to the safety of such
use, or 18 months after the date of enactment of the legislation
(unless extended by the Secretary for not more than an additional
12 months), whichever date occurs first.
Meat inspection
The bill as amended provides that nothing in this legislation shall
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546 LEGAL COMPILATION—PESTICIDES
be construed to exempt any meat or meat food product or any per-
son from any requirement imposed by or pursuant to the Meat
Inspection Act of March 4, 1907. This provision would leave unaf-
fected the jurisdiction of the Department of Agriculture with
respect to food additives in establishments which are subject to the
Meat Inspection Act.
The report of the Secretary of Health, Education, and Welfare
reads as follows:
THE SECRETARY OF HEALTH, EDUCATION, AND WELFARE
Washington, July 11,1958.
Hon. OREN HARRIS,
Chairman, Committee on Interstate and Foreign Commerce,
House of Representatives, Washington, D.C.
DEAR MR. HARRIS: We note with gratification that the Health and Science
Subcommittee of your committee has reported favorably a chemical food ad-
ditives bill based essentially on H. R. 6747. We appreciate your great interest
in this bill.
The subcommittee revision is acceptable to this Department.
Because of the urgent public health need for legislation requiring adequate
testing of additives before they are used in food, we hope your committee can
give favorable consideration to the new bill, H. R. 13254, in time for it to be
acted upon by this session of Congress.
[p. 7]
In view of the urgency, this communication has not been submitted to the
Bureau of the Budget for advice in accordance with the usual procedure on
reports.
Sincerely yours,
M. B. FOLSOM, Secretary.
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,
AS AMENDED
AN ACT To prohibit the movement in interstate commerce of adulterated and
misbranded food, drugs, devices, and cosmetics, and for other purposes
Be it enacted by the Senate and House of Representatives of the United States
of America in Congress assembled,
[p. 8]
(s) The term "food additive" means any substance the intended
use of which results or may reasonably be expected to result,
directly or indirectly, in its becoming a component or otherwise
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STATUTES AND LEGISLATIVE HISTORY 547
affecting the characteristics of any food (including any substance
intended for use in producing, manufacturing, packing, process-
ing, preparing, treating, packaging, transporting, or holding food;
and including any source of ionizing radiation intended for any
such use, if such substance is not generally recognized, among
experts qualified by scientific training and experience to evaluate
its toxicity or other potentiality for harm, as having been ade-
quately shown through scientific procedures (or, in the case of a
substance used in food prior to the date of enactment of this
paragraph, through either scientific procedures or experience
based on common use in food) to be safe under the conditions of its
intended use; except that such term does not include—
(1) a pesticide chemical in or on a, raw agricultural com-
modity; or
(2) a pesticide chemical to the extent that it is intended for
use in the production, storage, or transportation of any raw
agricultural commodity; or
(3) any substance used in accordance with a sanction or
approval granted prior to the enactment of this paragraph
pursuant to this Act or the Meat Inspection Act of March 4,
1907 (34 Stat. 1260), as amended and extended (21 U.S.C.
71 and the following).
(t) The term "safe", as used in paragraph (s) of this section and
in section 409, means ivithout hazard to the health of man or ani-
mal.
[P. 10]
ADULTERATED FOOD
SEC. 402. A food shall be deemed to be adulterated—
(a) (1) If it bears or contains any poisonous or deleterious sub-
stance which may render it injurious to health; but in case the sub-
stance is not an added substance such food shall not be considered
adulterated under this clause if the quantity of such substance in
such food does not ordinarily render it injurious to health; or (2)
(A) if it bears or contains any added poisonous or added deleteri-
ous substance, [except] (except a pesticide chemical in or on a raw
agricultural [commodity,] commodity and except food additive)
which is unsafe within the meaning of section 406, or (B) if it is a
raw agricultural commodity and it bears or contains a pesticide
chemical which is unsafe within the meaning- of section [408 (a) ]
408 (a), or (C) if it is, or it bears or contains, any food additive
which is unsafe within the meaning of section 409: Provided, That
where a pesticide chemical has been used in or on a raw agricul-
tural commodity in conformity with an exemption granted or a
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548 LEGAL COMPILATION—PESTICIDES
tolerance prescribed under section 408 and such raw agricultural
commodity has been subjected to processing by cooking, freezing,
dehydrating, or milling, the residue of such pesticide chemical
remaining in or on such processed food shall, notwithstanding the
provisions of sections 406 and 409, not be deemed unsafe if such
residue in or on the raw agricultural commodity has been removed
to the extent possible in good manufacturing practice and the con-
centration of such residue in the processed food when ready to eat
is not greater than the tolerance prescribed for the raw agricul-
tural commodity; or (3) if it consists in whole or in part of any
filthy, putrid, or decomposed substance, or if it is otherwise unfit
for food; or (4) if it has been prepared, packed, or held under
insanitary conditions whereby it may have become contaminated
with filth, or whereby it may have been rendered injurious to
health; or (5) if it is, in whole or in part, the product of a diseased
animal or of an animal which has died otherwise than by slaughter;
or (6) if its container is composed, in whole or in part, of any
poisonous or deleterious substance which may render the contents
injurious to health; or (7) if it has been intentionally subjected to
ionizing radiation, unless the use of the ionizing radiation was in
conformity with a regulation or exemption in effect pursuant to
section 409.
[p. 12]
TOLERANCES FOR POISONOUS INGREDIENTS IN FOOD AND CERTIFICA-
TION OF COAL-TAR COLORS FOR FOOD
SEC. 406. (a) Any poisonous or deleterious substance added to
any food, except where such substance is required in the produc-
tion thereof or cannot be avoided by good manufacturing practice
shall be deemed to be unsafe for purposes of the application of
clause (2) (A) of section 402 (a) ; but when such substance is so
required or cannot be so avoided, the Secretary shall promulgate
regulations3 limiting the quantity therein or thereon to such extent
as he finds necessary for the protection of public health, and any
quantity exceeding the limits so fixed shall also be deemed to be
unsafe for purposes of the application of clause (2) (A) of section
402 (a). While such a regulation is in effect limiting the quantity
of any such substance in the case of any food, such food shall not,
by reason of bearing or containing any added amount of such sub-
stance, be considered to be adulterated within the meaning of
clause (1) of section 402 (a). In determining the quantity of such
added substance to be tolerated in or on different articles of food
the Secretary shall take into account the extent to which the use
of such substance is required or cannot be avoided in the produc-
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STATUTES AND LEGISLATIVE HISTORY 549
tion of each such article, and the other ways in which the con-
sumer may be affected by the same or other poisonous or deleteri-
ous substances.
(b) The Secretary shall promulgate regulations providing for
the listing of coal-tar colors4 which are harmless and suitable for
use in food and for the certification of batches of such colors, with
or without harmless diluents.
[p. 15]
TOLERANCES FOR PESTICIDE CHEMICALS IN OR ON RAW AGRICULTURAL
COMMODITIES
SEC. 408. (a) Any poisonous or deleterious pesticide chemical, or
any pesticide chemical which is not generally recognized, among
experts qualified by scientific training and experience to evaluate
the safety of pesticide chemicals, as safe for use, added to a raw
agricultural commodity, shall be deemed unsafe for the purposes of
the application of clause (2) of section 402 (a) unless—
[P.16]
(1) a tolerance for such pesticide chemical in or on the raw
agricultural commodity has been prescribed by the Secretary
of Health, Education, and Welfare under this section and the
quantity of such pesticide chemical in or on the raw agricul-
tural commodity is within the limits of the tolerance so pre-
scribed ; or
(2) with respect to use in or on such raw agricultural com-
modity, the pesticide chemical has been exempted from the
requirement of a tolerance by the Secretary under this section.
While a tolerance or exemption from tolerance is in effect for a
pesticide chemical with respect to any raw agricultural commodity,
such raw agricultural commodity shall not, by reason of bearing or
containing any added amount of such pesticide chemical, be con-
sidered to be adulterated within the meaning of clause (1) of sec-
tion 402 (a).
(b) The Secretary shall promulgate regulations establishing tol-
erances with respect to the use in or on raw agricultural commodi-
ties of poisonous or deleterious pesticide chemicals and of pesticide
chemicals which are not generally recognized, among experts quali-
fied by scientific training and experience to evaluate the safety
of pesticide chemicals, as safe for use, to the extent necessary to
protect the public health. In establishing any such regulation, the
Secretary shall give appropriate consideration, among other rele-
vant factors, (1) to the necessity for the production of an ade-
quate, wholesome, and economical food supply; (2) to the other
ways in which the consumer may be affected by the same pesticide
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550 LEGAL COMPILATION—PESTICIDES
chemical or by other related substances that are poisonous or dele-
terious; and (3) to the opinion of the Secretary of Agriculture as
submitted with a certification of usefulness under subsection (1)
of this section. Such regulations shall be promulgated in the man-
ner prescribed in subsection (d) or (e) of this section. In carrying
out the provisions of this section relating to the establishment of
tolerances, the Secretary may establish the tolerance applicable
with respect to the use of any pesticide chemical in or on any raw
agricultural commodity at zero level if the scientific data before
the Secretary does not justify the establishment of a greater tol-
erance.
(c) The Secretary shall promulgate regulations exempting any
pesticide chemical from the necessity of a tolerance with respect to
use in or on any or all raw agricultural commodities when such
tolerance is not necessary to protect the public health. Such regula-
tions shall be promulgated in the manner prescribed in subsection
(d) or (e) of this section.
(d) (1) Any person who has registered, or who has submitted
an application for the registration of, an economic poison under the
Federal Insecticide, Fungicide, and Rodenticide Act may file with
the Secretary of Health, Education, and Welfare, a petition pro-
posing the issuance of a regulation establishing a tolerance for a
pesticide chemical which constitutes, or is an ingredient of, such
economic poison, or exempting the pesticide chemical from the
requirement of a tolerance. The petition shall contain data show-
ing—
(A) the name, chemical identity, and composition of the
pesticide chemical;
(B) the amount, frequency, and time of application of the
pesticide chemical;
(C) full reports of investigations made with respect to the
safety of the pesticide chemical;
[p. 17]
(D) the results of tests on the amount of residue remaining,
including a description of the analytical methods used;
(E) practicable methods for removing residue which
exceeds any proposed tolerance;
(F) proposed tolerances for the pesticide chemical if tol-
erances are proposed; and
(G) reasonable grounds in support of the petition.
Samples of the pesticide chemical shall be furnished to the Secre-
tary upon request. Notice of the filing of such petition shall be pub-
lished in general terms by the Secretary within thirty days after
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STATUTES AND LEGISLATIVE HISTORY 551
filing. Such notice shall include the analytical methods available for
the determination of the residue of the pesticide chemical for which
a tolerance or exemption is proposed.
(2) Within ninety days after a certification of usefulness by the
Secretary of Agriculture under subsection (1) with respect to the
pesticide chemical named in the petition, the Secretary of Health,
Education, and Welfare shall, after giving due consideration to the
data submitted in the petition or otherwise before him, by order
make public a regulation—
(A) establishing a tolerance for the pesticide chemical
named in the petition for the purposes for which it is so cer-
tified as useful, or
(B) exempting the pesticide chemical from the necessity of
a tolerance for such purposes,
unless within such ninety-day period the person filing the petition
requests that the petition be referred to an advisory committee or
.the Secretary within such period otherwise deems such referral
necessary, in either of which events the provisions of paragraph
(3) of this subsection shall apply in lieu hereof.
(3) In the event that the person filing the petition requests,
within ninety days after a certification of usefulness by the Secre-
tary of Agriculture under subsection (1) with respect to the pes-
ticide chemical named in the petition, that the petition be referred
to an advisory committee, or in the event the Secretary of Health,
Education, and Welfare within such period otherwise deems such
referral necessary, the Secretary of Health, Education, and Wel-
fare shall forthwith submit the petition and other data before him
to an advisory committee to be appointed in accordance with sub-
section (g) of this section. As soon as practicable after such refer-
ral, but not later than sixty days thereafter, unless extended as
hereinafter provided, the committee shall, after independent study
of the data submitted to it by the Secretary and other data before
it, certify to the Secretary a report and recommendations on the
proposal in the petition to the Secretary, together with all under-
lying data and a statement of the reasons or basis for the recom-
mendations. The sixty-day period provided for herein may be
extended by the advisory committee for an additional thirty days
if the advisory committee deems this necessary. Within thirty days
after such certification, the Secretary shall, after giving due con-
sideration to all data then before him, including such report, rec-
ommendations, underlying data, and statement, by order make
public a regulation—
(A) establishing a tolerance for the pesticide chemical
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552 LEGAL COMPILATION—PESTICIDES
named in the petition for the purposes for which it is so cer-
tified as useful; or
[P. 18]
(B) exempting the pesticide chemical from the necessity of
tolerance for such purposes.
(4) The regulations published under paragraph (2) or (3) of
this subsection will be effective upon publication.
(5) Within thirty days after publication, any person adversely
affected by a regulation published pursuant to paragraph (2) or
(3) of this subsection, or pursuant to subsection (e), may file
objections thereto with the Secretary, specifying with particular-
ity the provisions of the regulation deemed objectionable, stating
reasonable grounds therefor, and requesting a public hearing upon
such objections. A copy of the objections filed by a person other
than the petitioner shall be served on the petitioner, if the regula-
tion was issued pursuant to a petition. The petitioner shall have
two weeks to make a written reply to the objections. The Secretary
shall thereupon, after due notice, hold such public hearing for the
purpose of receiving evidence relevant and material to the issues
raised by such objections. Any report, recommendations, underly-
ing data, and reasons certified to the Secretary by an advisory com-
mittee shall be made a part of the record of the hearing, if rele-
vant and material, subject to the provisions of section 7 (c) of the
Administrative Procedure Act (5 U.S.C., sec 1006 (c)). The
National Academy of Sciences shall designate a member of the
advisory committee to appear and testify at any such hearing with
respect to the report and recommendations of such committee upon
request of the Secretary, the petitioner, or the officer conducting
the hearing: Provided, That this shall not preclude any other mem-
ber of the advisory committee from appearing and testifying at
such hearing. As soon as practicable after completion of the hear-
ing, the Secretary shall act upon such objections and by order make
public a regulation. Such regulation shall be based only on substan-
tial evidence of record at such hearing, including any report, rec-
ommendations, underlying data, and reasons certified to the Sec-
retary by an advisory committee, and shall set forth detailed find-
ings of fact upon which the regulation is based. No such order shall
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.
(e) The Secretary may at any time, upon his own initiative or
upon the request of any interested person, propose the issuance of
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STATUTES AND LEGISLATIVE HISTORY 553
a regulation establishing a tolerance for a pesticide chemical or
exempting it from the necessity of a tolerance. Thirty days after
publication of such a proposal, the Secretary may by order publish
a regulation based upon the proposal which shall become effective
upon publication unless within such thirty-day period a person
who has registered, or who has submitted an application for the
registration of, an economic poison under the Federal Insecticide,
Fungicide, and Rodenticide Act containing the pesticide chemical
named in the proposal, requests that the proposal be referred to an
advisory committee. In the event of such a request, the Secretary
shall forthwith submit the proposal and other relevant data before
him to an advisory committee to be appointed in accordance with
subsection (g) of this section. As soon as practicable after such
referral, but not later than sixty days thereafter, unless extended
as hereinafter provided, the committee shall, after independent
study of the data submitted to it by the Secretary and other data
[p. 19]
before it, certify to the Secretary a report and recommendations
on the proposal together with all underlying data and a state-
ment of the reasons or basis for the recommendations. The sixty-
day period provided for herein may be extended by the advisory
committee for an additional thirty days if the advisory committee
deems this necessary. Within thirty days after such certification,
the Secretary may, after giving due consideration to all data
before him, including such report, recommendations, underlying
data and statement, by order publish a regulation establishing a
tolerance for the pesticide chemical named in the proposal or
exempting it from the necessity of a tolerance which shall become
effective upon publication. Regulations issued under this subsec-
tion shall upon publication be subject to paragraph (5) of sub-
section (d).
(f) All data submitted to the Secretary or to an advisory com-
mittee in support of a petition under this section shall be con-
sidered confidential by the Secretary and by such advisory commit-
tee until publication of a regulation under paragraph (2) or (3)
of subsection (d) of this section. Until such publication, such data
shall not be revealed to any person other than those authorized
by the Secretary or by an advisory committee in the carrying out
of their official duties under this section.
(g) Whenever the referral of a petition or proposal to an ad-
visory committee is requested under this section, or the Secretary
otherwise deems such referral necessary, the Secretary shall
forthwith appoint a committee of competent experts to review
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554 LEGAL COMPILATION—PESTICIDES
the petition or proposal and to make a report and recommenda-
tions, thereon. Each such advisory committee shall be composed of
experts, qualified in the subject matter of the petition and of
adequately diversified professional background selected by the
National Academy of Sciences and shall include one or more
representatives from land-grant colleges. The size of the commit-
tee shall be determined by the Secretary. Members of an advisory
committee shall receive as compensation for their services a
reasonable per diem, which the Secretary shall by rules and regu-
lations prescribe, for time actually spent in the work of the com-
mittee, and shall in addition be reimbursed for their necessary
traveling and subsistence expenses while so serving away from
their places of residence. The members shall not be subject to any
other provisions of law regarding the appointment and compen-
sation of employees of the United States. The Secretary shall
furnish the committee with adequate clerical and other assistance,
and shall by rules and regulations prescribe the procedure to be
followed by the committee.
(h) A person who has filed a petition or who has requested the
referral of a proposal to an advisory committee in accordance
with the provisions of this section, as well as representatives of
the Department of Health, Education, and Welfare, shall have
the right to consult with any advisory committee provided for in
subsection (g) in connection with the petition or proposal.
(i) (1) In a case of actual controversy as to the validity of any
order under subsection (d) (5), (e), or (1) any person who will
be adversely affected by such order may obtain judicial review by
filing in the United States Court of Appeals for the circuit wherein
such person resides or has his principal place of business, or in the
United States Court of Appeals for the District of Columbia
[p. 20]
Circuit, within sixty days after the entry of such order, a petition
praying that the order be set aside in whole or in part.
(2) In the case of a petition with respect to an order under
subsection (d) (5) or (e), a copy of the petition shall be forth-
with served upon the Secretary, or upon any officer designated by
him for that purpose, and thereupon the Secretary shall certify
and file in the court a transcript of the proceedings and the record
on which he based his order. Upon such filing, the court shall have
exclusive jurisdiction to affirm or set aside the order complained
of in whole or in part. The findings of the Secretary with respect
to questions of fact shall be sustained if supported by substantial
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STATUTES AND LEGISLATIVE HISTORY 555
evidence when considered on the record as a whole, including any
report and recommendation of an advisory committee.
(3) In the case of a petition with respect to an order under
subsection (1), a copy of the petition shall be forthwith served
upon the Secretary of Agriculture, or upon any officer designated
by him for that purpose, and thereupon the Secretary shall certify
and file in the court a transcript of the proceedings and the
record on which he based his order. Upon such filing, the court
shall have exclusive jurisdiction to affirm or set aside the order
complained of in whole or in part. The findings of the Secretary
with respect to questions of fact shall be sustained if supported
by substantial evidence when considered on the record as a whole.
(4) If application is made to the court for leave to adduce
additional evidence, the court may order such additional evidence
to be taken before the Secretary of Health, Education, and Welfare
or the Secretary of Agriculture, as the case may be, and to be
adduced upon the hearing in such manner and upon such terms
and conditions as to the court may seem proper, if such evidence
is material and there were reasonable grounds for failure to
adduce such evidence in the proceedings below. The Secretary of
Health, Education, and Welfare or the Secretary of Agriculture,
as the case may be, may modify his findings as to the facts and
order by reason of the additional evidence so taken, and shall file
with the court such modified findings and order.
(5) The judgment of the court affirming or setting aside, in
whole or in part, any order under this section shall be final, subject
to review by the Supreme Court of the United States upon certior-
ari or certification as provided in section 1254 of title 28 of the
United States Code. The commencement of proceedings under this
section shall not, unless specifically ordered by the court to the
contrary, operate as a stay of an order. The courts shall advance
on the docket and expedite the disposition of all causes filed therein
pursuant to this section.
(j) The Secretary may, upon the request of any person who has
obtained an experimental permit for a pesticide chemical under
the Federal Insecticide, Fungicide, and Rodenticide Act or upon
his own initiative, establish a temporary tolerance for the pesticide
chemical for the uses covered by the permit whenever in his
judgment such action is deemed necessary to protect the public
health, or may temporarily exempt such pesticide chemical from a
tolerance. In establishing such a tolerance, the Secretary shall give
due regard to the necessity for experimental work in developing
an adequate, wholesome, and economical food supply and to the
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556 LEGAL COMPILATION—PESTICIDES
limited hazard to the public health involved in such work when
conducted in accordance with applicable regulations under the
Federal Insecticide, Fungicide, and Rodenticide Act.
[p. 21]
(k) Regulations affecting pesticide chemicals in or on raw agri-
cultural commodities which are promulgated under the authority
of section 406 (a) upon the basis of public hearings instituted
before January 1, 1953, in accordance with section 701 (e), shall
be deemed to be regulations under this section and shall be subject
to amendment or repeal as provided in subsection (m).
(1) The Secretary of Agriculture, upon request of any person
who has registered, or who has submitted an application for the
registration of, an economic poison under the Federal Insecticide,
Fungicide, and Rodenticide Act, and whose request is accompanied
by a copy of a petition filed by such person under subsection (d)
(1) with respect to a pesticide chemical which constitutes, or is
an ingredient of, such economic poison, shall, within thirty days
or within sixty days if upon notice prior to the termination of
such thirty days the Secretary deems it necessary to postpone
action for such period, on the basis of data before him, either—
(1) certify to the Secretary of Health, Education, and
Welfare that such pesticide chemical is useful for the pur-
pose for which a tolerance or exemption is sought; or
(2) notify the person requesting the certification of his
proposal to certify that the pesticide chemical does not appear
to be useful for the purpose for which a tolerance or exemp-
tion is sought, or appears to be useful for only some of the
purposes for which a tolerance or exemption is sought.
In the event that the Secretary of Agriculture takes the action
described in clause (2) of the preceding sentence, the person
requesting the certification, within one week after receiving the
proposed certification, may either (A) request the Secretary of
Agriculture to certify to the Secretary of Health, Education, and
Welfare on the basis of the proposed certification; (B) request a
hearing on the proposed certification or the parts thereof objected
to; or (C) request both such certification and such hearing. If no
such action is taken, the Secretary may by order make the certifi-
cation as proposed. In the event that the action described in clause
(A) or (C) is taken, the Secretary shall by order make the certifi-
cation as proposed with respect to such parts thereof as are
requested. In the event a hearing is requested, the Secretary of
Agriculture shall provide opportunity for a prompt hearing. The
certification of the Secretary of Agriculture as the result of such
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STATUTES AND LEGISLATIVE HISTORY 557
hearing shall be made by order and shall be based only on sub-
stantial evidence of record at the hearing and shall set forth
detailed findings of fact. In no event shall the time elapsing
between the making of a request for a certification under this sub-
section and final certification by the Secretary of Agriculture
exceed one hundred and sixty days. The Secretary shall submit
to the Secretary of Health, Education, and Welfare with any certi-
fication of usefulness under this subsection an opinion, based on
the data before him, whether the tolerance or exemption proposed
by the petitioner reasonably reflects the amount of residue likely
to result when the pesticide chemical is used in the manner pro-
posed for the purpose for which the certification is made. The
Secretary of Agriculture, after due notice and opportunity for
public hearing, is authorized to promulgate rules and regulations
for carrying out the provisions of this subsection.
[p. 22]
(m) The Secretary of Health, Education, and Welfare shall
prescribe by regulations the procedure by which regulations under
this section may be amended or repealed, and such procedure shall
conform to the procedure provided in this section for the promul-
gation of regulations establishing tolerances, including the appoint-
ment of advisory committees and the procedure for referring peti-
tions to such committees.
(n) The provisions of section 303 (c) of the Federal Food, Drug,
and Cosmetic Act with respect to the furnishing of guaranties
shall be applicable to raw agricultural commodities covered by
this section.
(o) The Secretary of Health, Education, and Welfare shall by
regulation require the payment of such fees as will in the aggre-
gate, in the judgment of the Secretary, be sufficient over a reason-
able term to provide, equip, and maintain an adequate service for
the performance of the Secretary's functions under this section.
Under such regulations, the performance of the Secretary's ser-
vices or other functions pursuant to this section, including any one
or more of the following, may be conditioned upon the payment
of such fees: (1) The acceptance of filing of a petition submitted
under subsection (d) ; (2) the promulgation of a regulation estab-
lishing a tolerance, or an exemption from the necessity of a toler-
ance, under this section, or the amendment or repeal of such a
regulation; (3) the referral of a petition or proposal under this
section to an advisory committee; (4) the acceptance for filing
of objections under subsection (d) (5) ; or (5) the certification
and filing in court of a transcript of the proceedings and the record
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558 LEGAL COMPILATION—PESTICIDES
under subsection (i) (2). Such regulations may further provide
for waiver or refund of fees in whole or in part when in the judg-
ment of the Secretary such waiver or refund is equitable and not
contrary to the purposes of this subsection.
FOOD ADDITIVES
Unsafe Food Additives
Sec. 409. (a) A food additive shall, with respect to any particular
use or intended use of such additives, be deemed to be unsafe for
the purposes of the application of clause (2) (C) of section 402
(a), unless—
(1) it and its use or intended use conform to the terms of
an exemption which is in effect pursuant to subsection (j)
of this section or
(2) there is in effect, and it and its use or intended use are
in conformity with, a regulation issued under this section
prescribing the conditions under which such additive may
be safely used.
While such a regulation relating to a food additive is in effect, a
food shall not, by reason of bearing or containing such an additive
in accordance with the regulation, be considered adulterated within
the meaning of clause (1) of section 402 (a).
Petition To Establish Safety
(b) (l)Any person may, with respect to any intended use of a
food additive, file with the Secretary a petition proposing the
issuance of a regulation prescribing the conditions under which
such additive may be safely used.
[p. 23]
(2) Such petition shall, in addition to stating reasonable grounds
in support of the petition, contain—
(A) the name and all pertinent information concerning
suck food additive, including, where available, its chemical
identity and composition;
(B) a statement of the conditions of the proposed use of
such additive, including all directions, recommendations, and
suggestions proposed for the use of such additive, and includ-
ing specimens of its proposed labeling;
(C) all relevant data bearing on the physical or other tech-
nical effect such additive is intended to produce, and the
quantity of such additive required to produce such effect;
(D) a full description of the methods used in, and the fa-
cilities and controls used for, the production of such additive;
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STATUTES AND LEGISLATIVE HISTORY 559
(E) a description of practicable methods for determining
the quantity of such additive in or on food, and any substance
formed in or on food, because of its use; and
(F) full reports of investigations made with respect to the
toxicity or other potentiality for harm of such additive, includ-
ing full information as to the methods and controls used in
conducting such investigations.
(3) Upon request of the Secretary, the petitioner shall furnish
samples of the food additive involved, or articles used as compo-
nents thereof, and of the food in or on which the additive is pro-
posed to be used.
(4) Notice of the regulation proposed by the petitioner shall be
published in general terms by the Secretary within thirty days
after filing.
Action on the Petition
(c) (1) The Secretary shall, in the absence of a referral, or
request for referral, to an advisory committee made pursuant to
subsection (e) of this section—
(A) by order establish a regulation (whether or not in
accord with that proposed by the petitioner) prescribing, with
respect to one or more proposed uses of the food additive
involved, the conditions under which such additive may be
safely used (including, but not limited to) specifications as to
the particular food or classes of food in or on which such
additive may be used, the maximum quantity which may be
used or permitted to remain in or on such food, the manner
in which such additive may be added to or used in or on such
food, and any directions or other labeling or packaging re-
quirements for such additive deemed necessary by him to
assure the safety of such use, and shall notify the petitioner
of such order; or
(B) by order deny the petition, and shall notify the peti-
tioner of such order and of the reasons for such action.
(2) The order required by paragraph (1) (A) or (B) of this
subsection shall be issued within ninety days after the date of
filing of the petition, except that the Secretary may (prior to such
ninetieth day), by written notice to the petitioner, extend such
ninety-day period to such time (not more than one hundred and
eighty days after the date of filing of the petition) as the Secretary
deems necessary to enable him to study and investigate the petition.
[p. 24]
(3) No such regulation shall issue if the data before the Secre-
tary—
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560 LEGAL COMPILATION—PESTICIDES
(A) fail to establish that the proposed use of the food addi-
tive, under the conditions of use to be specified in the regula-
tion, will be safe; or
(B) show that the proposed use of the additive would
promote deception of the consumer or would be otherwise
contrary to this Act.
(4) If, in the judgment of the Secretary, a tolerance limitation
is required in order to assure that the proposed use of an additive
will be safe, the Secretary—
(A) shall not fix such tolerance limitation at a level higher
than he finds to be reasonably required to accomplish the
physical or other technical effect for which such additive is
intended; and
(B) shall not establish a regulation for such proposed use
if he finds that the data before him do not establish that such
use would accomplish the intended physical or other technical
effect.
(5) In determining, for the purposes of this section, whether a
proposed use of a food additive is safe, the Secretary shall consider
among other relevant factors—
(A) the probable consumption of the additive and of any
substance formed in or on food because of the use of the
additive;
(B) the cumulative effect of such additive in the diet of
man or animals, taking into account any chemically or phar-
macologically related substance or substances in such diet; and
(C) appropriate safety factors for the use of animal experi-
mentation data.
Regulation Issued on Secretary's Initiative
(d) The Secretary may at any time, upon his own initiative,
propose the issuance of a regulation prescribing, with respect to
any particular use of a food additive, the conditions under which
such additive may be safely used. After the thirtieth day following
publication of such a proposal, the Secretary may by order estab-
lish a regulation based upon the proposal, unless within such thirty-
day period a person files a petition under subsection (b) with
respect to such additive and requests that the proposal, or any
question of fact raised thereby, be referred to an advisory com-
mittee appointed pursuant to subsection (e) of this section.
Reference to Advisory Committee
(e) (1) At any time before, or within thirty days after, publica-
tion of an order issued under subsection (c) or (d) of this section,
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STATUTES AND LEGISLATIVE HISTORY 561
the petitioner may request that the petition or order thereon, or
the Secretary's proposal, or any question raised by such petition,
order, or proposal, be referred to an advisory committee. Upon
such request, or if the Secretary within such time deems such a
referral necessary, the Secretary shall forthwith appoint an ad-
visory committee of competent experts to review the petition,
order, or proposal, or question, as the case may be, and to make a
report and recommendation thereon. Each such advisory commit-
tee shall be composed of experts, qualified in the subject matter
of the petition, order, proposal, or question, as the case may be,
and of adequately diversified professional background selected
by the National Academy of Sciences, except that in the event of
the inability or refusal of the National Academy of Sciences to
act, the Secretary shall select the members of the committee.
[p. 25]
The size of the committee shall be determined by the Secretary.
Members of an advisory committee shall receive as compensation
for their services a reasonable per diem, which the Secretary shall
by rules and regulations prescribe, for time actually spent in the
work of the committee, and shall in addition be reimbursed for
their necessary traveling and subsistence expenses while so serving
away from their places of residence. The members shall not be sub-
ject to any other provisions of law regarding the appointment and
compensation of employees of the United States. The Secretary
shall furnish the committee with adequate clerical and other assis-
tance, and shall by rules and regulations prescribe the procedure to
be followed by the committee. The Secretary shall refer the petition,
order, or proposal, or question, as the case may be, to the advisory
committee so appointed, and furnish such committee all the data
before him. A person who has filed a petition or who has requested
the referral of an order, proposal, or question, to an advisory
committee, as well as representatives of the Department of Health,
Education, and Welfare, shall have the right to consult with such
advisory committee in connection with the matter referred to it.
"(2) Within sixty days after the date of such referral, or within
an additional thirty days if the committee deems such additional
time necessary, the committee shall, after independent study of
the data furnished to it by the Secretary and other data before it,
certify to the Secretary a report and recommendations, together
with all underlying data and a statement of the reasons or basis
for the recommendations. Within thirty days after such certifica-
tion, and after giving due consideration to all data then before
him, including such report, recommendations, underlying data,
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562 LEGAL COMPILATION—PESTICIDES
and statement, and to any prior order issued by him in connection
with such matter, the Secretary shall confirm or modify any order
theretofore issued or, if no such order has been issued, shall by
order establish a regulation prescribing, with respect to any par-
ticular use of the food additive involved, the conditions under
which such additive may be safely used or shall, by order, deny
the petition.
(3) The Secretary may by regulation condition referrals to
advisory committees pursuant to this subsection upon the payment,
by the person requesting the referral, of fees to defray the costs
arising by reason of such referrals. Such fees, including advance
deposits to cover such fees, shall be available, until expended, for
paying (directly or by ivay of reimbursement of the applicable
appropriation) the expenses of advisory committees under this
subsection and other expenses arising by reason of referrals to
such committees, and for refunds of excess payments.
Publication and Effective Date of Orders
(f) Any order, including any regulation established by such
order, issued under subsection (c), (d), or (e) of this section, shall
be published and shall be effective upon publication, but the Secre-
tary may stay such effectiveness if, after issuance of such order,
the order or any question related thereto is referred to an advisory
committee pursuant to subsection (e) or if a hearing is sought
with respect to such order pursuant to subsection (g).
Objections and Public Hearing
(g) (1) Within thirty days after publication of an order made
pursuant to subsection (c), (d), or (e) of this section, any person
adversely affected by such an order may file objections thereto
[p. 26]
with the Secretary, specifying with particularity the provisions of
the order deemed objectionable, stating reasonable grounds there-
for, and requesting a public hearing upon such objections. The
Secretary shall thereupon, after due notice, hold such public hear-
ing for the purpose of receiving evidence relevant and material to
the issues raised by such objections. Any report', recommendations,
underlying data, and reasons certified to the Secretary by an ad-
visory committee shall be made a part of the record of the hearing
if relevant and material, subject to the provisions of section 7 (c)
of the Administrative Procedure Act (5 U.S.C., sec. 1006 (c)). The
advisory committee shall designate a member to appear and testify
at any such hearing with respect to the report and recommenda-
tions of such committee upon request of the Secretary, the peti-
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STATUTES AND LEGISLATIVE HISTORY 563
tioner, or the officer conducting the hearing, but this shall not
preclude any other member of the advisory committee from appear-
ing and testifying at such hearing. As soon as practicable after
completion of the hearing, the Secretary shall by order act upon
such objections and make such order public.
(2) Such order shall be based upon a fair evaluation of the entire
record at such hearing, including any report, recommendations,
underlying data, and reasons certified to the Secretary by an
advisory committee, and shall include a statement setting forth in
detail the findings and conclusions upon which the order is based.
(3) 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 Secre-
tary 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.
Judicial Review
(h) (1) In a case of actual controversy as to the validity of any
order issued under subsection (g), including any order thereunder
with respect to amendment or repeal of a regulation issued under
this section, any person who will be adversely affected by such
order may obtain judicial review by filing in the United States
court of appeals for the circuit wherein such person resides or has
his principal place of business, or in the United States Court of
Appeals for the District of Columbia Circuit, within sixty days
after the entry of such order, a petition praying that the order
be set aside in whole or in part.
(2) A copy of such petition shall be forthwith served upon the
Secretary or upon any officer designated by him for that purpose,
and thereupon the Secretary shall certify and file in the court a
transcript of the proceedings and the record on which he based his
order. Upon such filing, the court shall have exclusive jurisdiction
to affirm or set aside the order complained of in whole or in part.
The findings of the Secretary with respect to questions of fact shall
be sustained if based upon a fair evaluation of the entire record at
such hearing, including any report, recommendation, underlying
data, and reasons certified to the Secretary by an advisory com-
mittee.
(3) If application is made to the court for leave to adduce addi-
tional evidence, the court may order such additional evidence 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, if such evidence is material and there were rea-
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564 LEGAL COMPILATION—PESTICIDES
sonable grounds for failure to adduce such evidence in the proceed-
ings below. The Secretary may modify his findings as to the facts
[p. 27]
and order by reason of the additional evidence so taken, and shall
file with the court such modified findings and order.
(4) The judgment of the court affirming or setting aside, in
whole or in part, any order under this section shall be final, subject
to review by the Supreme Court of the United States upon certio-
rari or certification as provided in section 1254 of title 28 of the
United States Code. The commencement of proceedings under this
section shall not, unless specifically ordered by the court to the con-
trary, operate as a stay of an order. The court shall advance on the
docket and expedite the disposition of all causes filed therein pur-
suant to this section.
(5) The court, on such judicial review, shall not sustain the order
of the Secretary if he failed to comply with any requirement
imposed on him by subsection (g) (2) of this section.
Amendment or Repeal of Regulations
(i) The Secretary shall by regulation prescribe the procedure by
which regulations under the foregoing provisions of this section
may be amended or repealed, and such procedure shall conform to
the procedure provided in this section for the promulgation of such
regulations, including the appointment of advisory committees and
the procedure for referring matters to such committees.
Exemptions for Investigational Use
(j) Without regard to subsection (b) to (i), inclusive, of this
section, the Secretary shall by regulation provide for exempting
from the requirements of this section any food additive, and a ly
food bearing or containing such additive, intended solely for inves-
tigational use by qualified experts when in his opinion such exemp-
tion is consistent with the public health.
[p. 28]
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STATUTES AND LEGISLATIVE HISTORY 565
1.2e (2) Senate Committee on Labor and Public Welfare, S. REP.
No. 2422, 85th Cong., 2d Sess. (1958)
FOOD ADDITIVES AMENDMENT OF 1958
AUGUST 18 (legislative day, AUGUST 16), 1958.—Ordered to be printed
Mr. HILL, from the Committee on Labor and Public Welfare,
submitted the following
REPORT
[To accompany H. R. 13254]
The Committee on Labor and Public Welfare, to whom was
referred the bill (H. R. 13254) to protect the public health by
amending the Federal Food, Drug, and Cosmetic Act to prohibit
the use in food of additives which have not been adequately tested
to establish their safety, having considered the same, report favor-
ably thereon, with amendments, and recommended that the bill
do pass.
EXPLANATION
The two amendments which this committee has added to the
bill as passed by the House, which are discussed in detail below,
do not in any way change the substance or content of the bill which
passed the House of Representatives without dissent. They deal,
not with the content of that bill, but with related problems regard-
ing the ability of the Department of Health, Education, and Wel-
fare to secure and retain the services of individuals unquestionably
qualified to protect and to better the health of our people.
In explanation of the bill sent us by the House, passage of which
your committee recommends with additions but without change in
any of its provisions, we would point out first that under existing
law the Federal Government is unable to prevent the use in foods
of a poisonous or deleterious substance until it first proves that the
additive is poisonous or deleterious. To establish this proof through
experimentation with generations of mice or other animals may
require 2 years or even more on the part of the relatively few sci-
entists the Food and Drug Administration is able to assign to a
particular problem. Yet, until that proof is forthcoming, an
unscrupulous processor of foodstuffs is perfectly free to purvey to
millions of our people foodstuffs containing additives which may or
may not be capable of producing illness, debility, or death.
[p.l]
Your committee is pleased to report to the Congress that an
analysis of the hearings on this and related measures which have
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566 LEGAL COMPILATION—PESTICIDES
been held over a period of some 6 years shows clearly that an over-
whelming percentage of our food processors—and by this we mean
the processors of well over 95 percent of the foodstuffs Americans
eat—have voluntarily undertaken, at considerable expense to them-
selves, to thoroughly test and prove safe to humans any additives
they have considered adding to foods to make them more appetiz-
ing, better keeping, more palatable, or otherwise improved. None-
theless, existing law permits any processor who chooses to pay no
heed either to the public's health or to his continuance in one par-
ticular line of business to unfairly compete with responsible proc-
essors, to defy the Food and Drug Administration and to endanger
the health of millions by using an untested additive for as long a
time as it may take for the Government to suspect the deleterious-
ness of his additives, schedule research into its properties and
effects, and, finally—perhaps years later—to begin the years-long
experiments needed to prove the particular additive safe or unsafe.
This huge loophole is 1 of 2 flaws in existing law which, through this
measure, we are attempting to fill. This bill, if enacted, will require
the processor who wants to add a new and unproven additive to
accept the responsibility now voluntarily borne by all responsible
food processors of first proving it to be safe for ingestion by human
beings.
The second flaw in existing law which has proved detrimental to
consumers, to processors, and to our national economy and which
this bill seeks to remove is a provision which has inadvertently
served to unnecessarily proscribe the use of additives that could
enable the housewife to safely keep food longer, the processor to
make it more tasteful and appetizing, and the Nation to make use
of advances in technology calculated to increase and improve our
food supplies. Your committee agrees with the Food and Drug
Administration that existing law should be changed to permit the
use of such additives as our technological scientists may produce
and which may benefit our people and our economy when the pro-
posed usages of such additives are in amounts accepted by the Food
and Drug Administration as safe. The rulings of the Department
of Health, Education, and Welfare on such questions are, of course,
subject to judicial review. The concept of safety used throughout
this bill centers on the question of whether a substance is safe for
use with reference to the health of man or animal. As the report of
the Committee on Interstate and Foreign Commerce of the House
of Representatives states, "Safety requires proof of reasonable
certainty that no harm will result from the proposed use of an
additive." Conscious of the fact that any substance or, for that mat-
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STATUTES AND LEGISLATIVE HISTORY 567
ter, any particular food known to be good for the health of human
beings can be deleterious to the health of an individual who insists
on consuming inordinate amounts of it, the committee agrees with
the Food and Drug Administration that, instead of insisting on
proof beyond any possible doubt that no harm will result under any
conceivable circumstances from the use of a particular additive—
which could, of course, occur if an individual decided to eat a pound
of salt or drink 4 gallons of pure water in an hour—the test which
should determine whether or not a particular additive may be used
in a specific percentage of relationship to the volume of the product
to which it might be added should be that of reasonable certainty
[p. 2]
in the minds of competent scientists that the additive is not harm-
ful to man or animal, subject to the procedural safeguards provided
in the bill which assure the right to hearing and judicial review.
The bill, the passage of which your committee recommends,
would correct both of these flaws in existing law. It would put upon
the processor rather than our Government the burden of proving
that a newly discovered substance which a processor of foodstuffs
proposes to add to the food we eat is safe. It would make possible
the use of additives discovered by our scientists which, having been
adjudged safe for humans and animals when used in or within cer-
tain quantitative limits, could materially advance our ability to
make more wholesome foods available to more people at all seasons
and, perhaps, we hope, to assure to ourselves and others the ability
to stockpile supplies of healthful and appetizing foods over such
long periods of time as emergencies might make either desirable or
essential.
HISTORY OF LEGISLATION
This bill, the passage of which your committee recommends as
urgent, is the product of some 6 years of the most extensive and
intensive hearings on legislative proposals in a particular field of
which we have knowledge. To us it represents the workings of a
free society at its best. Through public hearings, carried on over a
period of 6 years, not only in every one of those 6 years but in every
part of the country as well, the Committee on Interstate and For-
eign Commerce of the House of Representatives was able to effect
a meeting of minds and to send us a bill which has the support not
only of those required by law to protect the Nation's health—the
officials of the Food and Drug Administration — but also of the
overwhelming majority of all those engaged in processing and sell-
ing the foodstuffs essential to the Nation's health.
Passage of this bill is strong recommended not only by the execu-
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568 LEGAL COMPILATION—PESTICIDES
tive branch of our Government but by each of the organizations
connected with the processing and distribution of foods listed
below:
National Canners Association
National Dairy Products Corp., Kraft Foods division
Grocery Manufacturers of America
Millers National Federation
American Bakers Association
Manufacturing Chemists Association
Dairy Industry Committee, speaking for—
The American Butter Institute
The American Dairy Milk Institute
The Evaporated Milk Association
The International Association of Ice Cream Manufacturers
The Milk Industry Foundation
The National Cheese Institute
The National Creameries Association
During the 81st Congress, a Select Committee to Investigate the
Use of Chemicals in Foods and Cosmetics (better known as the
Delaney committee, named after its chairman, Congressman James
J. Delaney) was created in the House of Representatives to study
the need to amend the present Federal Food, Drug, and Cosmetic Act
[P. 3]
in this respect. After extended hearings, the committee on June 30,
1952, filed a report (H. Kept. No. 2356, 82d Cong., 2d sess.) urging
amending the present law so that chemicals employed in or on
foods would be subjected to substantially the same safety require-
ments as exist in the law for new drugs.
Bills to accomplish the objectives of that report were introduced
by Congressman Delaney and referred to that committee during
the 83d Congress and subsequent Congresses, and other Members
of Congress introduced numerous bills differing from the prototype
bills primarily with respect to agency procedure and judicial
review.
During the 83d Congress, that committee held hearings arid
reported favorably related legislation providing for the pretesting
of, and the establishment of safe tolerances for, pesticide chemicals.
This bill was enacted into law (Public Law 518, 83rd Cong.).
During the 2nd session of the 84th Congress, the Subcommittee
on Health and Science of the Committee on Interstate and Foreign
Commerce of the House of Representatives, under the chairman-
ship of the late full committee chairman, J. Percy Priest, held 5
days of hearings on 10 bills dealing with chemical additives in and
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STATUTES AND LEGISLATIVE HISTORY 569
on food. The hearings indicated basic agreement with regard to
the need for chemical additive legislation, but also considerable
disagreement with regard to the agency and judicial review pro-
cedures to be followed in determining the safety of chemical addi-
tives. This agreement was not resolved, and no chemical additive
legislation was enacted during the 84th Congress.
During the 85th Congress, that subcommittee held 11 days of
hearings on 9 related bills: The hearings included 2 days of testi-
mony by a panel of outstanding scientists and experts selected by
the National Academy of Sciences at the request of the subcommit-
tee, to give the subcommittee scientific background with regard to
the testing and evaluating of chemical additives. The subcommittee
also heard witnesses from industry, labor, and consumer organiza-
tions, representatives from the Department of Health, Education,
and Welfare, including those from the Food and Drug Administra-
tion, and the chief judge of the third judicial circuit appearing on
behalf of the Judicial Conference of the United States.
As a result of those hearings and after consideration of the
many related bills on this subject before the subcommittee, its chair-
man, Congressman John Bell Williams of Mississippi, introduced
a clean bill (H. R. 13254) which was reported unanimously by the
subcommittee to the full Committee on Interstate and Foreign
Commerce of the House of Representatives. That bill with 1 minor
committee amendment which we shall discuss below passed the
House without dissent and with the 2 amendments added by your
committee is the bill now under consideration.
PRINCIPAL PROVISIONS OF LEGISLATION
Substances covered by legislation
Pretesting is required under this legislation only with respect to
those food additives which are not generally recognized among
competent experts as having been adequately shown to be safe
under the conditions of their intended use. An additive may be
shown to be safe either by means of scientific procedures (includ-
[p-4]
ing a review of the existing scientific literature) or, in the case of
substances in use prior to January 1, 1958, also by means of expe-
rience based on common use in food.
The legislation covers substances which are added intentionally
to food. These additives are generally referred to as "intentional
additives."
The legislation also covers substances which may reasonably be
expected to become a component of any food or to affect the char-
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570 LEGAL COMPILATION—PESTICIDES
acteristics of any food. These substances are generally referred to
as "incidental additives."
The principal examples of both intentional and incidental addi-
tives are substances intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, transporting,
or holding food.
On the other hand, substances which may accidentally get into a
food, as for example, paints or cleaning solutions used in food proc-
essing plants, are not covered by the legislation. These additives
are generally referred to as "accidental additives," since these sub-
stances if properly used may not reasonably be expected to become
a component of a food or otherwise to affect the characteristics of
a food. If accidental additives do get into food, the provisions of the
Food, Drug-, and Cosmetic Act dealing with poisonous and deleteri-
ous substances would be applicable.
Sources of radiation (including radioactive isotopes, particle
accelerators and X-ray machines) intended for use in processing
food are included in the term "food additive" as defined in this
legislation.
Exempted from the scope of the legislation are (1) pesticide
chemicals in or on raw agricultural commodities which are already
covered by the pesticide chemicals amendment of the Federal Food,
Drug, and Cosmetic Act (Public Law 518, 83d Cong.) ; (2) resi-
dues of pesticide chemicals unavoidably remaining on processed
foods not in excess of tolerances prescribed by Food and Drug
Administration for raw agricultural commodities; and (3) sub-
stances already approved under the provisions of the Federal Food,
Drug, and Cosmetic Act or the Meat Inspection Act of March 4,
1907.
The Secretary is given authority by this legislation to exempt by
regulation food additives for investigational use by qualified
experts when consistent with the public health.
Regulation to establish safety
A regulation prescribing the conditions under which an additive
may be safely used may be issued by the Secretary of Health, Edu-
cation, and Welfare either on the basis of a petition filed by any
person (ordinarily the manufacturer of the additive) or on the
Secretary's own initiative.
The petition would set forth the name and all pertinent informa-
tion concerning the additive, including, where available, its chemi-
cal identity and composition; full reports of scientific investigations
of safety for use; the conditions of the proposed use of such addi-
tive; all relevant data bearing on the physical or other technical
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STATUTES AND LEGISLATIVE HISTORY 571
effect such additive is intended to produce; the quantity required
to produce such effect; when requested by the Secretary, the meth-
ods used to produce the additive; and a description of practicable
methods to determine the quantity cf such additive left in or on
[p. 5]
food because of its use.
In addition, upon request of the Secretary, the petitioner would
be required to furnish (or, if he is not the manufacturer of the addi-
tive, to have the manufacturer furnish) to the Secretary a full
description of the methods, facilities, and controls used for the
production of the additive. Samples of the additive or its compo-
nents, or of the food in which it is to be used, would also have to
be furnished if requested by the Secretary.
Trade secrets supplied to the Secretary would be protected under
this legislation from unauthorized disclosure by departmental
personnel.
The Secretary would either, by order, establish a regulation pre-
scribing the conditions under which such additive may be safely
used, or he would, by order, deny the petition and notify the peti-
tioner of the reasons for such action. Such orders would be issued
within 90 days after the date of filing of the petition unless the
Secretary, by written notice to the petitioner, extends such period
for not more than an additional 90 days to enable him to study
the petition.
Concept of safety
The concept of safety used in this legislation involves the ques-
tion of whether a substance is hazardous to the health of man or
animal. Safety requires proof of a reasonable certainty that no
harm will result from the proposed use of an additive. It does not—
and cannot— require proof beyond any possible doubt that no
harm will result under any conceivable circumstance.
This was emphasized particularly by the scientific panel which
testified before the subcommittee. The scientists pointed out that
it is impossible in the present state of scientific knowledge to estab-
lish with complete certainty the absolute harmlessness of any
chemical substance.
In determining the "safety" of an additive, scientists must take
into consideration the cumulative effect of such additives in the diet
of man or animals over their respective life spans together with
any chemically or pharmacologically related substances in such
diet. Thus, the safety of a given additive involves informed judg-
ments based on educated estimates by scientists and experts of the
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572 LEGAL COMPILATION—PESTICIDES
anticipated ingestion of an additive by man and animals under
likely patterns of use.
Reasonable certainty determined in this fashion that an additive
will be safe, will protect the public health from harm and will per-
mit sound progress in food technology.
The legislation adopts this concept of safety by requiring the
Secretary to consider in addition to information with regard to the
specific additive in question, among others, the following relevant
factors: (1) the probable consumption of the additive and of any
substance formed in or on food because of the use of such additive;
(2) the cumulative effect of such additive in the diet of man or ani-
mals, taking into account any chemically or pharmacologically
related substances in such diet; and (3) safety factors which quali-
fied experts consider appropriate for the use of animal experimen-
tation data.
In determining the safety of an additive, the Secretary would
have to consider not only the food to which the additive is directly
added, but also other foods derived from such foods. For example,
in evaluating the safety of an additive for poultry feed, the Secre-
tary would have to consider any residues that might appear in
[p. 6]
eggs produced by the poultry. Similarly, in determining the safety
of additive-treated cattle feed, account would have to be taken of
residues of the additive in the milk or edible flesh of the animal.
Since the scientific investigation and the other relevant data to
be taken into consideration by the Secretary include information
with respect to possible cancer causing characteristics of a pro-
posed additive, the public will be protected from possible harm on
this count.
Grounds for denial of petition
The Secretary would deny a petition to establish the safety of an
additive if the data before the Secretary fail to establish that the
proposed use of the additive under the specified conditions of use
will be safe.
The Secretary could also deny a petition on the ground that the
proposed use of the additive would promote deception of the con-
sumer in violation of the Federal Food, Drug, and Cosmetic Act or
would otherwise result in adulteration or in misbranding of food
within the meaning of the Food and Drug Act.
Tolerance limitations
In the case of an additive which, in the judgment of the Secre-
tary based upon a fair evaluation of the data before him, requires
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STATUTES AND LEGISLATIVE HISTORY 573
a tolerance limitation in order to assure that the proposed use of
such additive will be safe, the legislation establishes two standards:
(1) The Secretary may not fix such tolerance limitation at
a level higher than he finds to be reasonably required to accom-
plish the physical or other technical effect for which such
additive is intended; and
(2) The Secretary may not establish a regulation for such
proposed use if he finds upon a fair evaluation of the data
before him that such data do not establish that such use would
accomplish the intended physical or other technical effect.
The phrase "physical or other technical effect" refers to the
objective effect which the additive may have on the appearance,
flavor, texture, or other aspects of a food. The question of whether
an additive produces such effect (or how much of an additive is
required for such effect) is a factual one, and does not involve any
judgment on the part of the Secretary of whether such effect
results in any added "value" to the consumer of such food or
enhances the marketability from a merchandising point of view.
Public hearings
Any person adversely affected by an order of the Secretary may
file objections thereto and request a public hearing. At such hear-
ings the Secretary would receive evidence relevant and material to
the issues raised and would by order act upon such objections.
Judicial review
The problem of the scope of judicial review under this legislation
is an important one. It was discussed exhaustively by several wit-
nesses before the House subcommittee, including a Federal judge
who testified on behalf of the Judicial Conference of the United
States.
Your committee agrees with the House that the Secretary's find-
ings of fact and orders should not be based on isolated evidence in
the record, which evidence in and of itself may be considered sub-
stantial without taking account of contradictory evidence of pos-
sibly equal or even greater substance.
[P-7]
Following the appearance before it of a panel of outstanding
scientists, the House subcommittee expressed itself as impressed
with the wide range of scientific judgment factors which are
involved in determining the safety of a food additive. Considering
the eminent qualifications of all the scientists and experts who
participated in these panel hearings, the scientific testimony of any
one of the participants must be considered "substantial evidence."
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574 LEGAL COMPILATION—PESTICIDES
Nevertheless, any conclusions based solely on the scientific judg-
ment of any one of the participants without taking account of con-
tradictory scientific views expressed by other participants cannot
be considered conclusions based upon a fair evaluation of the
entire record.
Thus, under this legislation, the Secretary's findings of fact and
orders based thereon must be based upon a fair evaluation of the
entire record. The committee adopted the language "fair evalua-
tion of the entire record" because it seemed to express most clearly
the standard of judicial review of administrative findings of fact
and orders based thereon which the committee feels should prevail.
The bill provides that the reviewing court shall not sustain the
order of the Secretary if he failed to base such order upon a fair
evaluation of the entire record at such hearing, or if he failed to
include in such order a statement setting forth in detail the find-
ings and conclusions upon which the order is based. The court must
sustain the findings of the Secretary with respect to questions of
fact if based upon a fair evaluation of the entire record.
Judicial review of any order of the Secretary under this legisla-
tion may be obtained in the United States court of appeals for the
circuit wherein appellant resides, or has his principal place of
business, or in the United States Court of Appeals for the District
of Columbia.
As the House committee's report makes clear, the specific lan-
guage of this bill—"fair evaluation of the entire record" — repre-
sents a new standard of judicial review, which differs from the
standard of "substantial evidence on the record as a whole" that
has heretofore been the criterion. The chairman of the House sub-
committee that drafted and reported the bill, Hon. John Bell Wil-
liams, used the following words in explaining to the House this
significant change in existing law:
Ever since the Congress began delegating regulatory func-
tions to administrative agencies of the Government there
has been disagreement among lawyers as to the fairness of the
procedures under which the agencies operate. In 1946, the
Administrative Procedure Act was passed in an effort to for-
malize the day-to-day rulemaking and regulatory procedures
of Government agencies. The 1946 act provides that unless
the findings of fact upon which administrative orders are
based are supported by "substantial evidence" a Federal court
of appeals can reverse the order of the administrative agency.
Court decisions have required that an administrative agency
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STATUTES AND LEGISLATIVE HISTORY 575
must give consideration to the entire record, including contra-
dictory evidence, when it determines facts.
Manufacturers of food and of food additives have mani-
fested concern that under an administrative type of control
over the use of food additives, such as is provided by H. R.
13254, it would be possible for the institutional decisions of
[p. 8]
the Secretary of Health, Education, and Welfare to be based,
for example, more upon the personal convictions of scientists
employed by the Food and Drug Administration regarding
the safety of an additive than upon the inferences fairly to
be drawn from the scientific evidence of record. H. R. 13254
provides that orders regarding the use of food additives must
"be based upon a fair evaluation of the entire record." The
committee has endeavored to prescribe a new statutory cri-
terion requiring that a high standard of fairness be observed
in administrative rulemaking under this bill. Personal atti-
tudes or preferences of administrative officials could not pre-
vail on the basis of being supported by substantial evidence
picked from the record without regard to other evidence of
probative value in the record. The United States Courts of
Appeals will be able to enforce this high standard by deter-
mining whether the Secretary of Health, Education, and Wel-
fare has given appropriate consideration to the inferences
which should fairly be drawn from all of the evidence of
record.
Effective date
This legislation will, except as hereinafter stated, take effect on
the date on which it is enacted. Thus the Food and Drug Adminis-
tration can immediately begin making determinations as to the
safety of food additives.
However, since it will take a certain amount of time to make
these determinations of safety, the provisions of section 3 of the
legislation (which will have the effect of permitting seizure, injunc-
tion suits, and criminal prosecutions on account of the shipment in
interstate commerce of an additive, or food containing an additive,
which has not been determined to be safe) will not take effect until
180 days after the enactment of this legislation.
A further exception is made in the case of any particular com-
mercial use of a food additive if such use began before January 1,
1958. In the case of such use, section 3 would take effect either on
the establishment of an order with respect to the safety of such
use, or 18 months after the date of enactment of the legislation
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576 LEGAL COMPILATION—PESTICIDES
(unless extended by the Secretary for not more than an additional
12 months), whichever date occurs first.
Meat inspection
The bill as amended provides that nothing in this legislation shall
be construed to exempt any meat or meat food product or any per-
son from any requirement imposed by or pursuant to the Meat
Inspection Act of March 4, 1907. This provision would leave unaf-
fected the jurisdiction of the Department of Agriculture with
respect to the use of food additives in meat or meat food products
in establishments which are subject to the Meat Inspection Act.
DEPARTMENTAL REPORT
The report of the Secretary of Health, Education, and Welfare
on S. 4193, sponsored by Senator Hill and Senator Smith of New
Jersey, which is identical, save for the nonsubstantive amend-
ments added by your committee and one amendment accepted by
[p-9]
the committee on the House of Representatives and discussed
below, is as follows:
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,
July S9, 1958.
Hon. LISTER HILL,
Chairman, Committee on Labor and Public Welfare,
United States Senate, Washington, D. C.
DEAR MR. CHAIRMAN: This is in response to your request for a report on
S. 4193, a bill to protect tlie public health by amending the Federal Food, Drug,
and Cosmetic Act to prohibit the use in food of additives which have not been
adequately tested to establish their safety.
S. 4193 is in substantial agreement with S. 1895 which was drafted in this
Department and submitted to the President of the Senate with our letter of
April 5, 1957 (copy enclosed). The discussion of the principal features of the
draft bill, which accompanied our letter of April 5, would apply in general
to S. 4193.
We understand that S. 4193 is identical with H. R. 13254, the bill drafted
by the House Committee on Interstate and Foreign Commerce after it held
extensive hearings on food additives legislation. In our letter of July 11, 1958,
to the chairman of the House Committee on Interstate and Foreign Com-
merce, we endorsed H. R. 13254 and it has now been reported favorably by
the House committee.
S. 4193 would accomplish the public health benefits that we envisioned in
drafting proposed legislation last year. We urgently recommend its enact-
ment or the enactment of H. R. 13254 at this session of Congress.
In view of the urgency, time has not permitted the submission of this re-
port to the Bureau of the Budget in accordance with the usual procedure.
Sincerely yours,
ELLIOT L. RICHARDSON,
Assistant Secretary.
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STATUTES AND LEGISLATIVE HISTORY 577
AMENDMENTS
Two amendments made by your committee to the bill as passed
by the House are explained below. We would like, in addition, to
call attention to the fact that the Committee on Interstate and For-
eign Commerce of the House of Representatives, before bringing
the bill to a vote in the House, decided to add to its previously
approved bill the provision which appears on page 8 of the House-
passed bill (lines 10 to 15) and reads as follows:
Provided, That no additive shall be deemed to be safe if it is
found to induce cancer when ingested by man or animal, or
if it is found, after tests which are appropriate for the evalua-
tion of the safety of food additives, to induce cancer in man
or animal;
Your committee, which has the responsibility in the Senate of con-
sidering all legislation primarily relating to the health of our
people, is well aware and thoroughly approving of the vast amount
of time and energy which Congressman Delaney, author of that
amendment, has devoted to the fight against cancer and to our
attempts to find its cause and cure. We have no objections to that
amendment whatsoever, but we would point out that in our opinion
[p. 10]
it is the intent and purpose of this bill, even without that amend-
ment, to assure our people that nothing shall be added to the foods
they eat which can reasonably be expected to produce any type of
illness in humans or animals. We applaud Congressman Delaney
for having taken this, as he has every other opportunity, to focus
our attention on the cancer-producing potentialities of various
substances, but we want the record to show that in our opinion
the bill is aimed at preventing the addition to the food our people
eat of any substances the ingestion of which reasonable people
would expect to produce not just cancer but any disease or disabil-
ity. In short, we believe the bill reads and means the same with or
without the inclusion of the clause referred to. This is also the view
of the Food and Drug Administration.
The first of the amendments added to the bill by your committee
appears on page 15 as section 8 of the bill. It would increase the
salary of the Commissioner of Food and Drugs from $17,500 to
$20,000. In recommending this increase, the Department of Health,
Education, and Welfare set forth its reasoning in a memorandum
to the committee which we set forth herewith.
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578 LEGAL COMPILATION—PESTICIDES
July 24,1958.
MEMORANDUM TO THE COMMITTEE ON LABOR AND PUBLIC WELFARE,
UNITED STATES SENATE
SALARY OF THE COMMISSIONER OF FOOD AND DRUGS
The position of Commissioner of Food and Drugs is currently classified as
GS-18, which carries a salary of $17,500. In the light of the scope and com-
plexity of the program administered by the Commissioner of Food and Drugs
the Department of Health, Education, and Welfare believes that his salary
should be increased to $20,000.
The importance of such an increase in the salary of the Commissioner of
Food and Drugs has now been accentuated by the provision of the recent
Classified Pay Act under which five much-needed scientific supergrade posi-
tions have been assigned to the Food and Drug Administration. Two of these
positions will carry salaries higher than the current salary of the Commis-
sioner; three will carry the same salary.
Statutory language to provide for the proposed increase is attached.
ELLIOT L. RICHARDSON,
Assistant Secretary.
Your committee not only agrees with the Department but also
believes the recommended action to be long overdue. We unani-
mously recommend its approval.
The second amendment adopted by the committee has to do with
key personnel attached to the National Institutes of Health. It
appears as section 9 on page 15 of the bill. It does not change the
maximum salary limitations under that section of the act it
amends, nor does it increase the total number of supergrade posi-
tions allocated by the Congress to the National Institutes of Health.
It merely clarifies the intent of the Congress that, just as in the
case of the recently enacted National Aeronautics and Space Act
in which that intent was explicitly set forth, so too in the case of
the National Institutes of Health do we intend to permit the
[p.11]
employment in these key positions of men with superior executive
and administrative skills as well as men with superior scientific
and professional skills.
CHEMICAL PRESERVATIVES
During the committee's deliberations on this measure, Senator
Goldwater questioned Commissioner Larrick of the Food and Drug
Administration concerning the Department's policies and regula-
tions with respect to preservatives which might be added to canta-
loups and other produce of the soil after harvesting. While those
questions are the subject of other legislation already on the statute
books and do not relate to the measure before us, the committee
believes that the explanation given by Commissioner Larrick con-
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STATUTES AND LEGISLATIVE HISTORY 579
cerning current law, policies, and regulations bearing on that
problem may well be of interest to individuals concerned with any
aspect of legislation dealing with the safety of foodstuffs. There-
fore, and in response to Senator Goldwater's request, the commit-
tee is happy to include in this report that confirmatory letter sent
by Commissioner Larrick to the chairman of this committee which
sums up the Commissioner's replies to Senator Goldwater's ques-
tions. It is as follows:
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,
August 15,1958.
Hon. LISTER HILL,
Chairman, Committee on Labor and Public Welfare,
United States Senate, Washington, D.C.
DEAR MR. CHAIRMAN : This confirms the statement I made today before the
Committee on Labor and Public Welfare in response to questions by Senator
Goldwater about the required declaration of the presence and the names of
chemical preservatives on cantaloups and other produce of the soil.
Cantaloups and other produce of the soil are not required to have a sticker
label on them for this purpose. If they are treated with a pesticide chemical
after harvest to prevent deterioration, it is enough that the shipping con-
tainer has a label giving this information. If the cantaloups are taken away
from the containers for retail sales display, all we require is that there be
a counter card containing the information. Each melon need not be marked.
Pesticide chemicals applied before harvest are used under spray schedules
and other safeguards developed by the Department of Agriculture arid dis-
seminated by the county agents, and by labeling on the pesticides themselves.
Since the packing-shed operator ordinarily has no means of knowing what
pesticides may have been used in growing all the fruit he buys, we have issued
an exempting regulation recognizing that it is impractical for him to label
fruit with information as to the preharvest treatment. We could not extend
this exemption to postharvest treatments because we could not make the sta-
tutory finding that the label declaration was impractical.
We have recognized that it may be impractical in the retail store to name
on the counter card the pesticides on citrus fruit, and have proposed a regu-
lation to require that the counter card have only the information that a pre-
servative has been used, but not the name of the preservative.
Sincerely yours,
GEO. P. LARRICK,
Commissioner of Food and Drugs.
[p.12]
CHANGES IN EXISTING LAW
In compliance with subsection (4) of rule XXIX of the Stand-
ing Rules of the Senate, 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
italics, existing law in which no change is proposed is shown in
roman) :
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580 LEGAL COMPILATION—PESTICIDES
FEDERAL FOOD, DRUG, AND COSMETIC ACT,
AS AMENDED
AN ACT To prohibit the movement in interstate commerce of adulterated
and misbranded food, drug's, devices, and cosmetics, and for other purposes
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
CHAPTER I—SHORT TITLE
SECTION 1. This Act may be cited as the Federal Food, Drug,
and Cosmetic Act.
*******
CHAPTER II—DEFINITIONS
SEC. 201. For the purposes of this Act—
*******
(s) The term "food additive" means any substance 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 (including any substance
intended for use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food;
and including any source of radiation intended for any such use),
if such substance is not generally recognized, among experts quali-
fied by scientific training and experience to evaluate its safety, as
having been adequately shown through scientific procedures (or,
in the case of a substance used in food prior to January 1, 1958,
through either scientific procedures or experience based on com-
mon use in food) to be safe under the conditions of its intended
use; except that such term does not include—
"(1) a pesticide chemical in or on a raw agricultural com-
modity; or
(2) a pesticide chemical to the extent that it is intended for
use or is used in the production, storage, or transportation of
any raw agricultural commodity; or
(3) any substance used in accordance with a sanction or
approval granted prior to the enactment of this paragraph
pursuant to this Act or the Meat Inspection Act of March
4,1907 (34 Stat. 1260), as amended and extended (21 U. S. C.
71 and the following)";
(t) The term "safe", as used in paragraph (s) of this section and
in section 409, has reference to the health of man or animal.
[p. 13]
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STATUTES AND LEGISLATIVE HISTORY 581
CHAPTER III—PROHIBITED ACTS AND PENALTIES
PROHIBITED ACTS
SEC. 301. The following acts and the causing thereof are hereby
prohibited:
*******
(j) The using by any person to his own advantage, or revealing,
other than to the Secretary or officers or employees of the Depart-
ment, or to the courts when relevant in any judicial proceeding
under this Act, any information acquired under authority of sec-
tion 404, 409, 505, 506, 507, or 704 concerning any method or proc-
ess which as a trade secret is entitled to protection.
*******
CHAPTER IV—FOOD
ADULTERATED FOOD
SEC. 402. A food shall be deemed to be adulterated—
(a) (1) If it bears or contains any poisonous or deleterious sub-
stance which may render it injurious to health; but in case the
substance is not an added substance such food shall not be consid-
ered adulterated under this clause if the quantity of such substance
in such food does not ordinarily render it injurious to health; or
(2) (A) if it bears or contains any added poisonous or added dele-
terious substance, [except] (except a pesticide chemical in or on
a raw agricultural [commodity,] commodity and except a food
additive) which is unsafe within the meaning of section 406, or
(B) if it is a raw agricultural commodity and it bears or contains
a pesticide chemical which is unsafe within the meaning of section
[408 (a) ] 408 (a), or (C) if it is, or it bears or contains, any food
additive which is unsafe within the meaning of section 409: Pro-
vided, That where a pesticide chemical has been used in or on a
raw agricultural commodity in conformity with an exemption
granted or a tolerance prescribed under section 408 and such raw
agricultural commodity has been subjected to processing such as
canning, cooking, freezing, dehydrating, or milling, the residue of
such pesticide chemical remaining in or on such processed food
shall, notwithstanding the provisions of sections 406 and 409, not
be deemed unsafe if such residue in or on the raw agricultural com-
modity has been removed to the extent possible in good 'manufac-
turing practice and the concentration of such residue in the
processed food when ready to eat is not greater than the tolerance
prescribed for the raw agricultural commodity; or (3) if it con-
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582 LEGAL COMPILATION—PESTICIDES
sists in whole or in part of any filthy, putrid, or decomposed sub-
stance, or if it is otherwise unfit for food; or (4) if it has been
prepared, packed, or held under unsanitary conditions whereby
it may have become contaminated with filth, or whereby it may
have been rendered injurious to health; or (5) if it is, in whole or
in part, the product of a diseased animal or of an animal which
has died otherwise than by slaughter; or (6) if its container is
composed, in whole or in part, of any poisonous or deleterious sub-
stance which may render the contents injurious to health; or (7)
if it has been intentionally subjected to radiation, unless the use
[p. 14]
of the radiation was in conformity with a regulation or exemption
in effect pursuant to section 409.
*******
TOLERANCES FOR POISONOUS INGREDIENTS IN FOOD AND CERTIFICA-
TION OF COAL-TAR COLORS FOR FOOD
SEC. 406. (a) Any poisonous or deleterious substance added to
any food, except where such substance is required in the produc-
tion thereof or cannot be avoided by good manufacturing practice
shall be deemed to be unsafe for purposes of the application of
clause (2) (A) of section 402 (a) ; but when such substance is so
required or cannot be so avoided, the Secretary shall promulgate
regulations limiting the quantity therein or thereon to such extent
as he finds necessary for the protection of public health, and any
quantity exceeding the limits so fixed shall also be deemed to be
unsafe for purposes of the application of clause (2) (A) of section
402 (a). While such a regulation is in effect limiting the quantity
of any such substance in the case of any food, such food shall not,
by reason of bearing or containing any added amount of such sub-
stance, be considered to be adulterated within the meaning of
clause (1) of section 402 (a). In determining the quantity of such
added substance to be tolerated in or on different articles of food
the Secretary shall take into account the extent to which the use
of such substance is required or cannot be avoided in the produc-
tion of each such article, and the other ways in which the consumer
may be affected by the same or other poisonous or deleterious sub-
stances.
*******
Food Additives
Unsafe Food Additives
SEC. 409. (a) A food additive shall, with respect to any particu-
lar use or intended use of such additives, be deemed to be unsafe
-------
STATUTES AND LEGISLATIVE HISTORY 583
for the purposes of the application of clause (2) (C) of section
402 (a), unless—
(1) it and its use or intended use conform to the terms of an
exemption which is in effect pursuant to subsection (i) of this
section; or
(2) there is in effect, and it and its use or intended use are
in conformity with, a regulation issued under this section pre-
scribing the conditions under which such additive may be
safely used.
While such a regulation relating to a food additive is in effect, a
food shall not, by reason of bearing or containing such an additive
in accordance with the regulation, be considered adulterated ivithin
the meaning of clause (1) of section 402 (a).
Petition to Establish Safety
(b) (1) Any person may, with respect to any intended use of a
food additive, file with the Secretary a petition proposing the issu-
ance of a regulation prescribing the conditions under which such
additive may be safely used.
[p. 15]
(2) Such petition shall, in addition to any explanatory or sup-
porting data, contain—
(A) the name and all pertinent information concerning such
food additive, including, where available, its chemical identity
and composition;
(B) a statement of the conditions of the proposed use of
such additive, including all directions, recommendations, and
suggestions proposed for the use of such additive, and includ-
ing specimens of its proposed labeling;
(C) all relevant data bearing on the physical or other tech-
nical effect such additive is intended to produce, and the quan-
tity of such additive required to produce such effect;
(D) a description of practicable methods for determining
the quantity of such additive in or on food, and any substance
formed in or on food, because of its use; and
(E) full reports of investigations made with respect to the
safety for use of such additive, including full information as
to the methods and controls used in conducting such investi-
gations.
(3) Upon request of the Secretary, the petitioner shall furnish
(or, if the petitioner is not the manufacturer of such additive, the
petitioner shall have the manufacturer of such additive furnish,
without disclosure to the petitioner) a full description of the meth-
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584 LEGAL COMPILATION—PESTICIDES
ods used in, and the facilities and controls used for, the production
of such additive.
(4) Upon request of the Secretary, the petitioner shall furnish
samples of the food additive involved, or articles used as compo-
nents thereof, and of the food in or on which the additive is pro-
posed to be used.
(5) Notice of the regulation proposed by the petitioner shall be
published in general terms by the Secretary within thirty days
after filing.
Action on the Petition
(c) (1) The Secretary shall—
(A) by order establish a regulation (whether or not in
accord with that proposed by the petitioner) prescribing, with
respect to one or more proposed uses of the food additive
involved, the conditions under ivhich such additive may be
safely used (including, but not limited to, specifications as
to the particular food or classes of food in or in which such
additive may be used, the maximum quantity which may be
used or permitted to remain in or on such food, the manner
in which such additive may be added to or used in or on such
food, and any directions or other labeling or packaging
requirements for such additive deemed necessary by him to
assure the safety of such use), and shall notify the petitioner
of such order and the reasons for such action; or
(B) by order deny the petition, and shall notify the peti-
tioner of such order and of the reasons for such action.
(2) The order required by paragraph (1) (A) or (B) of this sub-
section shall be issued within ninety days after the date of filing
of the petition, except that the Secretary may (prior to such nine-
tieth day), by written notice to the petitioner, extend such ninety-
day period to such time (not more than one hundred and eighty
days after the date of filing of the petition) as the Secretary deems
necessary to enable him to study and investigate the petition.
[P-16]
(3) No such regulation shall issue if a fair evaluation of the data
before the Secretary—
(A) fails to establish that the proposed use of the food
additive, under the conditions of use to be specified in the
regulation, will be safe: Provided, That no additive shall be
deemed to be safe if it is found to induce cancer when ingested
by man or animal, or if it is found, after tests which are
appropriate for the evaluation of the safety of food additives,
to induce cancer in man or animal; or
-------
STATUTES AND LEGISLATIVE HISTORY 585
(B) shows that the proposed use of the additive would pro-
mote deception of the consumer in violation of this Act or
would otherwise result in adulteration or in misbranding of
food within the meaning of this Act.
(4) If, in the judgment of the Secretary, based upon a fair
evaluation of the data before him, a tolerance limitation is required
in order to assure that the proposed use of an additive will be safe,
the Secretary—
(A) shall not fix such tolerance limitation at a level higher
than he finds to be reasonably required to accomplish the
physical or other technical effect for which such additive is
intended; and
(B) shall not establish a regulation for such proposed use if
he finds upon a fair evaluation of the data before him that
such data do not establish that such use would accomplish the
intended physical or other technical effect.
(5) In determining, for the purposes of this section, whether a
proposed use of a food additive is safe, the Secretary shall consider
among other relevant factors—
(A) the probable consumption of the additive and of any
substance formed in or on food because of the use of the
additive;
(B) the cumulative effect of such additive in the diet of man
or animals, taking into account any chemically or pharmaco-
logically related substance or substances in such diet; and
(C) safety factors which in the opinion of experts qualified
by scientific training and experience to evaluate the safety of
food additives are generally recognized as appropriate for the
use of animal experimentation data.
Regulation Issued on Secretary's Initiative
(d) The Secretary may at any time, upon his own initiative, pro-
pose the issuance of a regulation prescribing, with respect to any
particular use of a food additive, the conditions under which such
additive may be safely used, and the reasons therefor. After the
thirtieth day following publication of such a proposal, the Secre-
tary may by order establish a regulation based upon the proposal.
Publication and Effective Date of Orders
(e) Any order, including any regulation established by such
order, issued under subsection (c) or (d) of this section, shall be
published and shall be effective upon publication, but the Secretary
may stay such effectiveness if, after issuance of such order, a hear-
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586 LEGAL COMPILATION—PESTICIDES
ing is sought with respect to such order pursuant to subsection (f).
[P. 17]
Objections and Public Hearing
(f) (1) Within thirty days after publication of an order made
pursuant to subsection (c) or (d) of this section, any person
adversely affected by such an order may file objections thereto
with the Secretary, specifying with particularity the provisions of
the order deemed objectionable, stating reasonable grounds there-
for, and requesting a public hearing upon such objections. The
Secretary shall, after due notice, as promptly as possible hold such
public hearing for the purpose of receiving evidence relevant and
material to the issues raised by such objections. As soon as prac-
ticable after completion of the hearing, the Secretary shall by
order act upon such objections and make such order public.
(2) Such order shall be based upon a fair valuation of the entire
record at such hearing, and shall include a statement setting forth
in detail the findings and conclusions upon which the order is based.
(3) 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 effec-
tive date, in which event the Secretary shall specify in the order
his findings as to such conditions.
Judicial Review
(g) (1) In a case of actual controversy as to the validity of any
order issued under subsection (f), including any order thereunder
with respect to amendment or repeal of a regulation issued under
this section, any persons who will be adversely affected by such
order may obtain judicial review by filing in the United States
Court of Appeals for the circuit wherein such person resides or has
his principal place of business, or in the United States Court of
Appeals for the District of Columbia Circuit, within sixty days
after the entry of such order, a petition praying that the order be
set aside in whole or in part.
(2) A copy of such petition shall be forthwith served upon the
Secretary, or upon any officer designated by him for that purpose,
and thereupon the Secretary shall certify and file in the court a
transcript of the proceedings and the record on which he based his
order. Upon such filing, the court shall have exclusive jurisdiction
to affirm or set aside the order complained of in whole or in part.
The findings of the Secretary with respect to questions of fact
shall be sustained if based upon a fair evaluation of the entire
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STATUTES AND LEGISLATIVE HISTORY 587
record at such hearing. The court shall advance on the docket and
expedite the disposition of all causes filed therein pursuant to this
section.
(3) The court, on such judicial review, shall not sustain the order
of the Secretary if he failed to comply with any requirement im-
posed on him by subsection (f) (2) of this section.
(4) If application is made to the court for leave to adduce addi-
tional evidence, the court may order such additional evidence 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, if such evidence is material and there were
reasonable grounds for failure to adduce such evidence in the pro-
ceedings below. The Secretary may modify his findings as to the
facts and order by reason of the additional evidence so taken, and
shall file with the court such modified findings and order.
[P. 18]
(5) The judgment of the court affirming or setting aside, in whole
or in part, any order under this section shall be final, subject to
review by the Supreme Court of the United States upon certiorari
or certification as provided in section 1254 of title 28 of the United
States Code. The commencement of proceedings under this section
shall not, unless specifically ordered by the court to the contrary,
operate as a stay of an order.
Amendment or Repeal of Regulations
(h) The Secretary shall by regulation prescribe the procedure by
which regulations under the foregoing provisions of this section
may be amended or repealed, and such procedure shall conform
to the procedure provided in this section for the promulgation of
such regulations.
Exemptions for Investigational Use
(i) Without regard to subsections (b) to (h), inclusive, of this
section, the Secretary shall by regulation provide for exempting
from the requirements of this section any food additive, and any
bearing or containing such additive, intended solely for investi-
gational use by qualified experts when in his opinion such exemp-
tion is consistent with the public health.
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588 LEGAL COMPILATION—PESTICIDES
PUBLIC HEALTH SERVICE ACT, AS AMENDED (42 U.S.C.
310 (g))
*******
SEC. 208.
*******
(g) The Secretary is authorized to establish and fix the com-
pensation for, within the Public Health Service, not more than
eighty-five positions of which not less than seventy-three shall be
for the National Institutes of Health in the professional, [and]
scientific, and executive service, each such position being estab-
lished to effectuate those research and development activities of
the Public Health Service which require the services of specially
qualified scientific, [or] professional, and administrative person-
nel : Provided, That the rates of compensation for positions estab-
lished pursuant to the provisions of this subsection shall not be less
than $12,500 per annum nor more than $19,000 per annum, and
shall be subject to the approval of the Civil Service Commission.
Positions created pursuant to this subsection shall be included in
the classified civil service of the United States but appointment to
such positions shall be made without competitive examination upon
approval of the proposed appointee's qualification by the Civil
Service Commission or such officers and agents as it may desig-
nate for this purpose.
[p. 19]
1.2e (3) CONGRESSIONAL RECORD, VOL. 104 (1958)
1.2e (3) (a) Aug. 23: Amended and passed Senate, pp. 19358-
19359
[No Relevant Discussion on Pertinent Section]
1.2e (3) (b) Aug. 23: House concurs in Senate amendments, p.
19641
[No Relevant Discussion on Pertinent Section]
1.2f. COLOR ADDITIVES AMENDMENTS OF 1960
July 12, 1960, P.L. 86-618, Title I, Section 103(a) (1), 74 Stat. 398
REGULATIONS TO ASSURE SAFETY OP 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
secti°n: [p. 398]
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STATUTES AND LEGISLATIVE HISTORY 589
1.2f (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, sub-
mitted 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
cosmetics, in accordance with regulations prescribing the condi-
tions (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 amend-
ed, 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 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
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590 LEGAL COMPILATION—PESTICIDES
meaning harmless regardless of the quantity of the coal-tar color
which is being used. Thus, a color must be decertified if any quan-
[p.l]
tity or concentration of the color is harmful, even though in lesser
concentrations it may be perfectly safe. Because of this principle,
as denned 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 adopt-
ed by the committee. Both amendments were developed coopera-
tively by the committee staff, representatives of the industries
concerned, and representatives of the Food and Drug Administra-
tion. 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 consid-
ered "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 Internationa] 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
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STATUTES AND LEGISLATIVE HISTORY 591
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 immediate
action in this field, and, second, letters dated August 7 and August
12, 1959, from Elliot L. Richardson, Assistant Secretary, Depart-
ment of Health, Education, and Welfare, expressing approval of
the committee amendments.
[p. 2]
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,
Washington, D.C., May 29,1959
Hon. RICHARD M. NIXON,
President of the Senate,
Washington, D.C.
DEAR MR. PRESIDENT : We are enclosing herewith a draft bill 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 food, drugs, and
cosmetics, in accordance with' regulations prescribing the conditions (in-
cluding maximum tolerances) under which such additives may be safely
used. The bill may be referred to by the short title "Color Additive Amend-
ments of 1959."
We respectfully urge the prompt consideration and enactment of this bill
by Congress.
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 addi-
tives of any kind which may safely be used in foods, drugs, or cosmetics, sub-
ject, when necessary, to appropriate tolerance limitations and other condi-
tions of use and to official certification of batches of color so as to assure the
safety of such use to the consumer.
The principal reasons which give rise to the need for this legislation may
be summarized as follows:
1. The law with respect to coal-tar colors—and this comprises most syn-
thetic colors—is not in consonance with modern concepts of consumer pro-
tection, in that it does not allow us to list a color for safe use under regula-
tions which place a limit on the amount of a color that may be used on an
article and to establish other conditions of use. For food, and for drugs and
cosmetics other than those externally applied, we must ban the use of such
a color completely as not being "harmless," if it is found to be toxic in the
laboratory when fed in some concentrations, even though its actual level and
manner of use may be completely safe; for externally applied drugs and
cosmetics the same principle applies if toxicity appears in the laboratory in
some concentrations by any relevant type of test, even though its actual
level and manner of use is wholly safe.
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592 LEGAL COMPILATION—PESTICIDES
The principle of allowing colors to be used under tolerance limitations
was endorsed in 1956 by a committee of recognized scientists appointed by
the National Academy of Sciences to review the coal-tar color research pro-
gram of the Food and Drug Administration, as indicated by the following
excerpt from the committee's report: "This committee feels compelled to
indicate that certification of a compound as 'harmless and suitable for use'
in food, drugs, and cosmetics as required under present law is unrealistic
unless the level of use is specified."
2. The theoretically "perfect" public-health protection once thought to be
accorded by the present law regarding coal-tar colors has turned out to be in
fact inadequate. While, theoretically, only "harmless" colors may be listed,
[p. 3]
a retesting program of the Food and Drug Administration, employing the
most modern testing techniques, has led to the discovery that many, perhaps
most, of the so-called colors on the list may in fact be toxic in some concen-
trations; yet we cannot take a particular color off the list until we esta-
blish its toxicity by laboratory tests, a process which for the list as a whole
may take as much as 20 years. Under the bill, there would, in general, be a
maximum of 2% years during which the retesting process for the established
colors would have to be completed—primarily by industry—and during which
we could establish temporary tolerance limitations, at zero level if neces-
sary, to protect the public health. This maximum period could be extended only
where, in a particular case, such extension is necessary to complete the re-
quired safety tests for a color and is found consistent with protection of the
public health.
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 require-
ments and, where necessary for the protection of color users and consumers,
the same requirement for certification of colors to assure their purity and
identity with those listed as safe. At present there are no provisions for the
certification of non-coal-tar colors; there is, moreover, no pretesting require-
ment for non-coal-tar color additives as such, other than food additives.
4. Unless the law, as proposed by the bill, is brought into conformity with
modern methods of control by incorporation of the safe-for-use principle, it
will become increasingly difficult, and may eventually become impossible, to
find permissible colors to supply the demand for various important color uses
on the part of consumers as well tgs the food, drug and cosmetic industries.
From the standpoint of the public intefest there is no compensating advan-
tage for the inflexibility of the present law in this respect.
The scientifically sound principle that we must consider conditions of use
when passing on suitability and safety of a color additive has recently been
approved by Congress in temporary emergency legislation (Public Law 86-2)
with respect to one coal-tar color,'f.e., citrus red No. 2 for use in coloring
oranges, after previous adoption of the safe-for-use principle in the Food
Additives Amendment of 1958 (Public Law 85-929). The only reason we had
suggested to Congress that the emergency legislation for citrus red No. 2
have a termination date was that color legislation limited to particular colors
and articles of food is discriminatory and that permanent legislation on this
subject should contain additional safeguards. Moreover, Public Law 86-2
on its face indicates the expectation that Congress will before long address
itself to the problem of general color legislation.
The bill—by permitting, for a reasonable period, the provisional listing and
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STATUTES AND LEGISLATIVE HISTORY 593
certification of heretofore commercially established colors, under temporary
tolerances where necessary for public-health protection, pending the develop-
ment of the scientific data required for a definitive determination as to the
listing of these colors under the permanent provisions of the bill—would
permit an orderly transition to the control procedures of the bill. At the
same time, the bill would establish on a permanent basis a sound system of
color regulation fully protective of consumer interests.
A more detailed explanation of the principal changes made in existing
law, and the reasons therefor, is attached to the draft bill. There is also en-
closed herewith a section-by-section analysis of the bill.
[p. 4]
The establishment of a tolerance system in this field requires, to an extent
not involved in a system without tolerance limitations, a program of educa-
tion of the user industries and public, and a program of enforcement activi-
ties by a thoroughly trained corps of inspectors and analysts. The fee pro-
visions, which are the same as those under existing law for coal-tar colors,
would defray only the cost of maintaining the listing and certification service;
additional costs would be incurred for the enforcement and informational
activities required by the establishment of a tolerance system. Enclosed here-
with, as required by Public Law 801, 84th Congress, are statements of cost
estimates and personnel requirements which would be entailed.
We should appreciate it if you would refer the enclosed draft bill, with the
accompanying material, to the appropriate committee for consideration.
The Bureau of the Budget advises that there is no objection to the presen-
tation of this proposed legislation to the Congress for its consideration.
Sincerely yours,
ARTHUR S. FLEMMING, Secretary
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,
Washington, August 7, 1959
Hon. LISTER HILL,
Chairman, Committee on Labor and Public Welfare,
U.S. Senate, Washington, D.C.
DEAR MR. CHAIRMAN: We understand that representatives of some of the
industries that would be affected by S. 2197 (to be known as the Color Addi-
tive Amendments of 1959) have suggested to your committee an amendment
to the bill relating to the requirements concerning analytical methods for
color additives, and that an expression of our views on the amendment is
desired.
Under the bill in its present form (p. 9, lines 3-16), the proposed section
706 (b) (4) of the Federal Food, Drug, and Cosmetic Act would preclude the
Secretary from listing a color additive for any use in or on food, drugs, or
cosmetics unless the data before him establish—
"(A) that such use, under the conditions of use to be specified in the
regulations, will be safe;
"(B)that practicable methods of analysis exist for determining the quan-
tity of the pure dye and all intermediates and other impurities contained
in such color additive; and
"(C) that practicable methods exist for determining the identity and
quantity (i) of such additive in or on any article of food, drug, or cosmetic,
-------
594 LEGAL COMPILATION—PESTICIDES
and (ii) of any substance formed in or on such article because of the use
of such additive."
The proposed amendment suggested by industry representatives would
consolidate the matter contained in the above-quoted paragraphs (b) and (c)
and, with appropriate editorial revision, transfer it to section 706 (b) (5),
which begins on the same page and enumerates some of the most important
factors which the Secretary must consider in passing on the safety of a pro-
posed use of a color additive. As so amended, section 706(b) (4) and (5), be-
ginning on page 9, line 3, and ending on page 10, line 9, of the bill, would
read as follows:
"(4) The Secretary shall not list a color additive under this section for a
proposed use unless the data before him establish that such use, under the
conditions of use specified in the regulations, will be safe.
[p. 5]
"(5) In determining, for the purposes of this section, whether a proposed
use of a color additive is safe, the Secretary shall consider, among other
relevant factors—
"(A) the probable consumption of, or other relevant exposure from, the
additive and of any substance formed in or on food, drugs, or cosmetics
because of the use of the additive;
"(B) the cumulative effect, if any, of such additive in the diet of man
or animals, taking into account the same or any chemically or pharmaco-
logically related substance or substances in such diet;
"(C) safety factors which, in the opinion of experts qualified by scien-
tific training and experience to evaluate the safety of color additives for
the use or uses for which the additive is proposed to be listed, are generally
recognized as appropriate for the use of animal experimentation data; and
"(D) the availability of any needed practicable methods of analysis for
determining the identity and quantity of (i) the pure dye and all inter-
mediates and other impurities contained in such color additive, (ii) such
additive in or on any article of food, drug, or cosmetic, and (iii) any sub-
stance formed in or on such article because of the use of such additive."
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 pro-
posed 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 analyses are available to him, without
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 requirement that there be practicable
methods for determining the identity 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 present state of knowledge and that, in those cases in which there is
no need for such a method of analysis for adequate public health protection,
the requirement would unnecessarily bar the use of a color additive which
would be perfectly safe.
The purpose of the requirement of the bill that there be practicable methods
of analysis for determining the quantity of the pure dye and all interme-
-------
STATUTES AND LEGISLATIVE HISTORY 595
diates and other impurities contained in a color additive is to enable the
manufacturer of the color, and also this Department where we are asked to
certify batches of color, to determine that the color in actual practice meets
the requirements for purity and the definitional standards of our regulations
and to facilitate enforcement. The purpose of the other requirements as to
available practicable methods of analysis is to make possible effective en-
forcement of any conditions or limitations that may be put on the listing of
a color for use in foods, drugs, or cosmetics. We, of course, regard practica-
bility and facility of enforcement as essential elements of safety in deter-
mining whether a proposed use of a color additive is safe within the meaning
of the bill.
[p. 6]
There are many circumstances where it would be necessary to have prac-
ticable analytical methods for all or most of the above-mentioned purposes.
We can, however, visualize some situations in which these analytical methods,
or some of them, would not be necessary for any of the purposes which we
have mentioned and would thus not be essential in the interest of sound public
health protection. We therefore recognize that in requiring such analytical
methods to be available in all cases without regard to actual need the original
bill goes further than absolutely necessary for public health protection.
Under the proposed change, we would consider ourselves bound to require
those analytical methods specified in the bill for which, on the basis of our
general knowledge or on the basis of the particular situation, we find that
there is a need for the above-mentioned purposes, or otherwise in the interest
of safeguarding the public health, and we would therefore feel bound to refuse
to list a color where such needed methods are not available. At the same time,
the proposed amendment would relieve us of the necessity of imposing these
requirements where they are not needed.
We therefore would not object to the proposed change in the bill.
The Bureau of the Budget advises that it perceives no objection to the
submission of this report to your committee.
Sincerely yours,
ELLIOT L. RICHARDSON,
Assistant Secretary
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,
Washington, D.C., August 12,1959
Hon. LISTER HILL,
U.S. Senate, Washington, D.C.
DEAR SENATOR HILL: Reference is made to S. 2197. We have had an oppor-
tunity to consider the suggestions of members of your staff with regard to
the status of coloring materials which are exempt from the provisions of the
Food Additives Amendment, Public Law 85-929.
Materials which are generally recognized as safe for their intended use by
experts qualified by training and experience to evaluate safety of foods are
exempt from the provisions of the food additives amendment. We see no rea-
son why such coloring materials as fall within this category and are found
by the Secretary to be so classified should not be listed as suitable for use in
food under the provisions of the color additive bill, S. 2197, and at the same
time be exempt from the certification procedures provided for in that bill.
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596 LEGAL COMPILATION—PESTICIDES
The language to reach this end is supplied herewith. We are satisfied that
this same result would be obtained under the bill in any event.
Sincerely yours,
ELLIOT L. RICHARDSON,
Assistant Secretary
EXPLANATION OF PRINCIPAL FEATURES AND PURPOSES OF THE COLOR
ADDITIVE AMENDMENTS OF 1959
The letter of transmittal from the Secretary of Health, Educa-
tion, and Welfare, briefly summarizes the general objectives of
S. 2197, the principal reasons which gave rise to it, and previous
[p. 7]
amendments to the Federal Food, Drug, and Cosmetic Act which, in
the case of food, show congressional endorsement of its key prin-
ciple ; i.e., recognition of the scientific 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.
A. PRESENT LAW
Under present law, the treatment of color additives differs
radically as between the so-called coal-tar colors and others. (For
explanation of the technical difference between so-called coal-tar
colors and others, see the discussion under "Major Changes
Proposed.")
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
purposes only). (See sees. 402(c), 406(b), 501 (a) (4), 504,
601 (e), 604, and 701 (c) and (f) of the act.) Under these provi-
sions, the Secretary is 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 re-
quirement 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).
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STATUTES AND LEGISLATIVE HISTORY 597
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 subject to any requirement of "batch" certification even if, in
view of the Administrator, this would be desirable for the protec-
tion 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 establish
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 accomplished
by excepting color additives (as defined in the bill) from the term
"food additive"; repealing the present provisions for listing and
[p. 8]
certification of coal-tar colors; enacting, as part of a single section
(sec. 706), comprehensive provisions for the separate listing of
any color additives suitable and safe for general or restricted use
in foods, drugs, or cosmetics, and for their certification (or exemp-
tion 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
constituent as to be capable of derivation therefrom even when
not actually so derived. S. 2197 would embrace all color additives
whether or not synthesized and whether or not capable of deriva-
tion from a coal-tar constituent. From the point of view of deter-
mining 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.
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598 LEGAL COMPILATION—PESTICIDES
Doing away with the distinction between so-called coal-tar colors
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.
2. Safety-of-use principle.—S. 2197 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.—S 2197, 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
exception from listing for colors "generally recognized" by experts
as safe for use. While there was 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 recognized
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 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
certification is not necesssary 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
[p. 9]
defining the color's identity. The committee believes, however, that
power to exempt colors from the certification requirement is desir-
able, especially since the coverage of the law is broadened to
include all types of substances capable of imparting color. One of
the amendments adopted by the committee provides that a color
additive deemed safe under the provisions of the Food Additives
-------
STATUTES AND LEGISLATIVE HISTORY 599
Amendment of 1956 shall be exempt from the requirement for
certification.
5. Effective date and transitional provisions.—The amendments
made by the bill to the Federal Food, Drug, and Cosmetic Act, i.e.,
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
provisions 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 certified
prior to the date of enactment of the bill, and (b) those non-coal-
tar colors, and synthetic, beta-carotene, which were commercially
used or sold prior to that date for food, drug, or cosmetic use.
Provisional listings would be subject to appropriate temporary
tolerance limitations and other conditions of use when deemed nec-
essary for 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
transitional 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 re-
spect to those colors and uses thereof for which the data available
to him do not establish a reliable basis for inclusion in a list of
colors deemed provisionally listed and for determining the prevail-
ing levels of use thereof prior to the enactment date.
In general, a provisional listing would terminate no later than
the end of the 2i/2-year period beginning on that date of enact-
ment. However, where necessary to complete the scientific testing
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600 LEGAL COMPILATION—PESTICIDES
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.
[p. 10]
C. NEED FOR THE BILL
The interests of consumer protection and of the food, drug,
cosmetic, and color industries combine to make urgent the need
for enactment of this bill.
1. Consumer protection.—First. Under present law the Govern-
ment 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. The bill would require indus-
try to assume the burden of this testing, and would require the
tests to be completed within 2i/2 years or, in individual cases, such
additional testing period as is shown to be required and to be con-
sistent with public-health protection. Further, it would allow the
Secretary to place safe tolerance limitations on the amount of
color that may be used and the products on which it may be used
during this transition period; the Secretary has no such authority
under present law.
Second. Other important aspects of consumer protection afforded
by the bill are (a) that the pretesting requirement would be ex-
tended to those non-coal-tar colors, especially those used in cos-
metics and drugs, to which it does not now apply, and (b) that the
requirement of certification of batches of color, where necessary
for the protection of the public health, would be extended to all
colors.
Third. The use of color in foods, drugs, and cosmetics, though
largely of value from the point of view of enhancing the market-
ability of the articles involved, is, in many cases, also in the con-
sumer's interest and affirmatively desired by consumers. This is
obviously so not only in the case of cosmetics, many of which are
designed and purchased for the very purpose of imparting color,
but also in the case of certain foods, e.g., margarine, where con-
sumers demand artificial color. Housewives also frequently pur-
chase certified color for use in home-prepared foods. In drugs,
color additives are much used for ready identification, thus helping
the pharmacist, the physician, the nurse, and the patient to avoid
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STATUTES AND LEGISLATIVE HISTORY 601
dangerous mistakes in choosing the wrong bottle or box. Thus, it
is in the interest of the consumer that the law be changed so as to
make available an adequate supply of colors of the safety of which,
for particular uses, the consumer can be assured.
2. Commercial interests.—The food, drug, cosmetic, and color
industries find themselves in a serious situation as the result of
the removal of color after color from the lists under the present
inflexible provisions of the law. Unless the law, by permitting
the listing of colors under safe tolerances, is brought into line
with present-day methods of control, the emergency will grow
and deepen, an emergency which, we believe, could be relieved for
most established colors on a sound and permanent basis by enact-
ing the provisions of S. 2197 without in any way conflicting with
the need for adequate protection of the public health.
There is no justification, from the point of view of the public
interest, in driving either color manufacturers or food, drug, or
cosmetic producers, dependent upon the use of color, out of busi-
ness where the particular use of color involved is one which can
safely be admitted under proper conditions of use (including toler-
ance limitations and certification requirements) established by the
Secretary.
[p. 11]
The technical provisions and approach of this bill are summar-
ized in detail in the section-by-section analysis which follows.
SECTION-BY-SECTION ANALYSIS OF "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
Secretary 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 cosmetic
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602 LEGAL COMPILATION—PESTICIDES
(other than a hair dye (defined to exclude eyelash and eyebrow
dyes)) containing a coal-tar color is deemed adulterated by section
601 (e) unless the color is from a batch certified by the Secretary
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,
the food additive is deemed unsafe unless it and its use (or in-
tended use) conform to a regulation under section 409 announcing
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 provisions
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
permitted 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.
[p. 12]
II. SECTIONAL ANALYSIS
Title I—Amendments to Federal Food, Drug, and Cosmetic Act
*******
Section 102 (a)
Paragraph (1) adds color additives to the exceptions from sec-
tion 402(a) (2) (A) of the act, which now declares adulterated
any food bearing or containing a poisonous or deleterious added
substance which is unsafe within the meaning of section 406 of the
act "except a pesticide chemical in or on a raw agricultural commod-
ity and except a food additive." This paragraph of the bill makes
explicit, with regard to color additives, the interpretation of the
Supreme Court in Flemming v. Florida Citrus Exchange, 358 U.S.
153 (1958), that section 406(a) of existing law—which authorizes
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STATUTES AND LEGISLATIVE HISTORY 603
the establishment of tolerances for poisonous or deleterious sub-
stances added to food where the additive is required in the produc-
tion of the food or cannot be avoided by good manufacturing
practice—cannot serve as a basis for allowing the use of coal-tar
colors where marketability of a food depends on such coloring.
Under the bill, section 706 of the act would (except during a tran-
sitional period) provide the exclusive procedure for the listing
(with or without tolerance limitations) and certification of color
additives.
Paragraph (2) amends section 402 (c) to deem a food adulter-
ated if "it is, or it bears or contains," a "color additive" which is
"unsafe within the meaning of section 706 (a)" of the basic act
[p. 13]
as enacted by the bill. This would replace the present requirement
of section 402 (c) that deems adulterated a food bearing a coal-tar
color which is not from a batch certified under section 406 (b),
and the provisos to section 402 (c) with respect to the use of color
on oranges. (See Public Law 86-2.) (Sec. 406 (b) of the act would
be repealed under another section of the bill.) The effect of these
changes would be to (a) make the new provisions applicable to all
color additives, whether or not they are coal-tar colors; (b) extend
them to the color additive itself before being added to food; and
(c) use the technique of the pesticide chemicals amendment and
food additives amendment by deeming the article adulterated if
the additive is "unsafe" under another section (in this case the
amended sec. 706) of the basic act which sets forth the criteria
under which the additive shall be deemed unsafe.
Paragraph (3) adds to section 403 of the basic act a new sub-
section (1), whereby a food which is a color additive is deemed
misbranded unless packaged and labeled in accordance with pack-
aging and labeling requirements, if any, contained in regulations
issued under section 706 (as amended by the bill). (Under the
basic act's definition of "food," a color additive intended to be
added to food is itself considered "food" before it is so added.)
[P-14]
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.
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604 LEGAL COMPILATION—PESTICIDES
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.15]
*******
TOLERANCES FOR POISONOUS INGREDIENTS IN FOOD AND CERTIFICA-
TION OF COAL-TAR COLORS FOR FOOD
SEC. 406 [(a)]
*******
[ (b) The Secretary shall promulgate regulations providing for
the listing of coal-tar colors which are harmless and suitable for
use in food and for the certification of batches of such colors, with
or without harmless diluents.]
*******
[p. 23]
LISTING AND CERTIFICATION OF COLOR ADDITIVES FOR FOODS, DRUGS,
AND COSMETICS
When Color Additives Deemed Unsafe
Sec. 706. (a) A color additive shall, with respect to any par-
ticular use (for which it is being used or intended to be used or is
represented as suitable) in or on food or drugs or cosmetics, be
deemed unsafe for the purposes of the application of section
402 (c), section 501 (a) (4), or section 601 (e), as the case may be,
unless—
(1) (A) there is in effect, and such additive and such use
are in conformity with, a regulation issued under subsection
(b) of this section listing such additive for such use, including
any provision of such regulation prescribing the conditions
under which such additive may be safely used, and (B) such
additive either (i) is from a batch certified, in accordance with
regulations issued pursuant to subsection (c), for such use, or
(ii), has, with respect to such use, been exempted by the
Secretary from the requirement of certification; or
(2) such additive and such use thereof conform to the terms
of an exemption which is in effect pursuant to subsection (f)
of this section.
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STATUTES AND LEGISLATIVE HISTORY 605
While there are in effect regulations under subsections (b) and
(c) of this section relating to a color additive or an exemption
[p. 25]
pursuant to subsection (f) with respect to such additive, an
article shall not, by reason of bearing or containing such additive
in all respects in accordance with such regulations or such exemp-
tion, be considered adulterated within the meaning of clause (1)
of section 402 (a) if such article is a food, or within the meaning
of section 601 (a) if such article is a cosmetic other than a hair dye
(as defined in the last sentence of section 601 (a)).
Listing of Colors
(b)(l) The Secretary shall, by regulation, provide for separately
listing color additives for use in or on food, color additives for use
in or on drugs, and color additives for use in or on cosmetics, if
and to the extent that such additives are suitable and safe for any
such use when employed in accordance with such regulations.
(2)(A) Such regulations may list any color additive for use
generally in or on food, or in or on drugs, or in or on cosmetics, if
the Secretary finds that such additive is suitable and may safely be
employed for such general use.
(B) If the data before the Secretary do not establish that the
additive satisfies the requirements for listing such additive on the
applicable list pursuant to subparagraph (A) of this paragraph,
or if the proposal is for listing such additive for a more limited
use or uses, such regulations may list such additive only for any
more limited use or uses for ivhich it is suitable and may safely be
employed.
(3) Such regulations shall, to the extent deemed necessary by
the Secretary to assure the safety of the use or uses for which a
particular color additive is listed, prescribe the conditions under
which such additive may be safely employed for such use or uses
(including, but not limited to, specifications, hereafter in this
section referred to as tolerance limitations, as to the maximum
quantity or quantities which may be used or permitted to remain
in or on the article or articles in or on which it is used, specifica-
tions as to the manner in which such additive may be added to or
used in or on such article or articles; and directions or other
labeling or packaging requirements for such additive).
(4) The Secretary shall not list a color additive under this sec-
tion for a proposed use unless the data before him establish that
such use, under the conditions of use specfied in the regulations,
win be safe: Provided, however, That a color additive shall be
deemed to be suitable and safe for the purpose of listing under this
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606 LEGAL COMPILATION—PESTICIDES
subsection for use generally in or on food, while there is in effect
a published finding of the Secretary declaring such substance
exempt from the term "food additive" because of its being gener-
ally recognized by qualified experts as safe for its intended use,
as provided in section 201 (s).
(5) In determining, for the purposes of this section, whether a
proposed use of a color additive is safe, the Secretary shall con-
sider, among other relevant factors—
(A) the probable consumption of, or other relevant ex-
posure from, the additive and of any substance formed in or
on food, drugs, or cosmetics because of the use of the additive;
(B) the cumulative effect, if any, of such additive in the
diet of man or animals, taking into account the same or any
chemically or pharmacologically related substance or sub-
stances in such diet;
(C) safety factors which, in the opinion of experts qualified
by scientific training and experience to evaluate the safety
[p. 26]
of color additives for the use or uses for which the additive
is proposed to be listed, are generally recognized as appropri-
ate for the use of animal experimentation data; and
(D) the availability of any needed practicable methods of
analysis for determining the identity and quantity of (i) the
pure dye and all intermediates and other impurities contained
in such color additive, (ii) such additive in or on any article
of food, drug, or cosmetic, and (Hi) any substance formed in
or on such article because of the use of such additive.
(6) The Secretary shall not list a color additive under this
subsection for a proposed use if the data before hint show that such
proposed use would promote deception of the consumer in violation
of this Act or ivould otherwise result in misbranding or adultera-
tion loithin the meaning of this Act.
(7) If, in the judgment of the Secretary, a tolerance limitation
is required in order to assure that a proposed use of a color additive
will be safe, the Secretary—
(A) shall not list the additive for such use if he finds that
the data before him do not establish that such additive, if
used within a safe tolerance limitation, would achieve the
intended physical or other technical effect; and
(B) shall not fix such tolerance limitation at a level higher
than he finds to be reasonably required to accomplish the
intended physical or other technical effect.
(8) If, having regard to the aggregate quantity of color additive
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STATUTES AND LEGISLATIVE HISTORY 607
likely to be consumed in the diet or to be applied to the human
body, the Secretary finds that the data before him fail to show that
it would be safe and otherwise permissible to list a color additive
(or pharmacologically related color additives) for all the uses
proposed therefor and at the levels of concentration proposed, the
Secretary shall, in determining for which use or uses such additive
(or such related additives) shall be or remain listed, or how the
aggregate allowable safe tolerance for such additive or additives
shall be allocated by him among the uses under consideration,
take into account, among other relevant factors (and subject to the
paramount criterion of safety), (A) the relative marketability of
the articles involved as affected by the proposed uses of the color
additive (or of such related additives) in or on such articles, and
the relative dependence of the industries concerned on such uses;
(B) the relative aggregate amounts of such color additive which
he estimates would be consumed in the diet or applied to the human
body by reason of the various uses and levels of concentration
proposed; and (C) the availability, if any, of other color additives
suitable and safe for one or more of the uses proposed.
Certification of Colors
(c) The Secretary shall further, by regulation, provide (1) for
the certification, ivith safe diluents or ivithout diluents, of batches
of color additives listed pursuant to subsection (b) and conforming
to the requirements for such additives established by regulations
under such subsection and this subsection, and (2) for exemption
from the requirement of certification in the case of any such addi-
tive, or any listing or use thereof, for which he finds such require-
ment not to be necessary in the interest of the protection of the
public health: Provided, That, with respect to any use in or on food
for which a listed color additive is deemed to be safe by reason of
[p. 27]
the proviso to paragraph (4) of subsection (b), the requirement
of certification shall be deemed not to be necessary in the interest
of public health protection.
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
issuance, amendment, or repeal of regulations under subsections
(b), (c), or (e) of this section (including judicial review of the
Secretary's action in such proceedings) and the admissibility of
transcripts of the record of such proceedings in other proceedings,
except that—
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608 LEGAL COMPILATION—PESTICIDES
(1) the Secretary's order after public hearing (acting upon
objections filed to an order made prior to hearing) shall be
sub feet 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]
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STATUTES AND LEGISLATIVE HISTORY 609
1.2f (2) HOUSE COMMITTEE ON INTERSTATE AND
FOREIGN COMMERCE
H.R. REP. No. 1761, 86th Cong., 2d Sess. (1960)
CONTENTS
Page
Committee amendments 1
Purpose of legislation 6
General summary 6
Hearings 6
Background information:
Coal-tar colors 6
Other colors 7
Need for legislation 8
Explanation of committee bill 10
Major changes proposed:
(1) Uniform criteria of admissibility 10
(2) Safety-of-use principle 11
(3) Delaney anticancer clause 11
(4) Comprehensive lists , 15
(5) Certification and exemptions from certification 15
(6) Effective date and transitional provisions 15
(7) Deception 16
(8) Recommended amendments to Food Additives Amendment 17
Explanation of principal committee amendments 17
(1) Agricultural chemicals affecting color 17
(2) Color additives extended under Food Additives Amendment 18
(3) Analytical methods for color additives 18
(4) Ad hoc scientific advisory committee on carcinogenicity of additive.. 19
(5) Color additive deemed to be safe under the proviso in section 706(b) (4)
need not be certified 20
(6) Time schedule governing action on a petition 20
(7) Review of regulation by Secretary terminating or placing a tolerance
limitation on a provisional listing 21
Reports from executive departments and agencies 21
Section-by-section analysis 21
Changes in existing law 32
Appendix 61
(p. iii)
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610 LEGAL COMPILATION—PESTICIDES
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 admendments, as they appear in the reported bill, are as
follows:
(1) On page 1, line 4, strike out "1959" and insert in lieu thereof
"1960".
(2) On page 3, line 9, strike out the quotation mark, and im-
mediately below line 9, insert the following:
"(3) Nothing in subparagraph (1) of this paragraph shall
be construed to apply to any pesticide chemical, soil or plant
nutrient, or other agricultural chemical solely because of
its effect in aiding, retarding, or otherwise affecting, directly
or indirectly, the growth or other natural physiological proc-
esses of produce of the soil and thereby affecting its color,
whether before or after harvest."
(3) On page 9, strike out lines 8 through 21 and insert in lieu
thereof the following:
" (4) The Secretary shall not list a color additive under this
section for a proposed use unless the data before him establish
that such use, under the conditions of use specified in the
regulations, will be safe: Provided, however, That a color
additive shall be deemed to be suitable and safe for the pur-
[P. 1]
pose of listing under this subsection for use generally in or on
food, while there is in effect a published finding of the Secre-
tary declaring such substance exempt from the term 'food
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STATUTES AND LEGISLATIVE HISTORY 611
additive' because of its being generally recognized by quali-
fied experts as safe for its intended use, as provided in section
201 (s).
(4) On page 10, line 19, strike out "and".
(5) On page 10, line 25, strike out the period and insert in lieu
thereof "; and".
(6) On page 11, immediately above line 8, insert the following:
"(iv) the availability of any needed practicable methods
of analysis for determining the identity and quantity of (I)
the pure dye and all intermediates and other impurities con-
tained in such color additive, (II) such additive in or on any
article of food, drug, or cosmetic, and (III) any substance
formed in or on such article because of the use of such additive.
(7) On page 11, lines 10, 12, and 19, immediately after "found"
insert "by the Secretary".
(8) On page 11, immediately below line 20, insert the following:
"(C) (i) In any proceeding for the issuance, amendment,
or repeal of a regulation listing a color additive, whether com-
menced by a proposal of the Secretary on his own initiative
or by a proposal contained in a petition, the petitioner, or any
other person who will be adversely affected by such proposal
or by the Secretary's order issued in accordance with para-
graph (1) of section 701 (c)) if placed in effect, may request,
within the time specified in this subparagraph, that the peti-
tion or order thereon, or the Secretary's proposal, be referred
to an advisory committee for a report and recommendations
with respect to any matter arising under subparagraph (B)
of this paragraph, which is involved in such proposal or order
and which requires the exercise of scientific judgment. Upon
such request, or if the Secretary within such time deems such
a referral necessary, the Secretary shall forthwith appoint an
advisory committee under subparagraph (D) of this para-
graph and shall refer to it, together with all the data before
him, such matter arising under subparagraph (B) for study
thereof and for a report and recommendations on such mat-
ter. A person who has filed a petition or who has requested
the referral of a matter to an advisory committee pursuant to
this subparagraph (C), as well as representatives of the
Department of Health, Education, and Welfare, shall have the
right to consult with such advisory committee in connection
with the matter referred to it. The request for referral under
this subparagraph, or the Secretary's referral on his own
initiative, may be made at any time before, or within thirty
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612 LEGAL COMPILATION—PESTICIDES
days after, publication of an order of the Secretary acting
upon the petition or proposal.
"(ii) Within sixty days after the date of such referral or
within an additional thirty days if the committee deems such
additional time necessary, the committee shall, after inde-
pendent study of the data furnished to it by the Secretary
[p. 2]
and other data before it, certify to the Secretary a report and
recommendations, together with all underlying data and a
statement of the reasons or basis for the recommendations.
A copy of the foregoing shall be promptly supplied by the
Secretary to any person who has filed a petition, or who has
requested such referral to the advisory committee. Within
thirty days after such certification, and after giving due
consideration to all data then before him, including such
report, recommendations, underlying data, and statement,
and to any prior order issued by him in connection with such
matter, the Secretary shall by order confirm or modify any
order theretofore issued or, if no such prior order has been
issued, shall by order act upon the petition or other proposal.
(iii) Where—
" (I) by reason of subparagraph (B) of this paragraph,
the Secretary has initiated a proposal to remove from
listing a color additive previously listed pursuant to this
section; and
"(II) a request has been made for referral of such
proposal to an advisory committee;
the Secretary may not act by order on such proposal until
the advisory committee has made a report and recommenda-
tions to him under clause (ii) of this subparagraph and he
has considered such recommendations, unless the Secretary
finds that emergency conditions exist necessitating the issu-
ance of an order notwithstanding this clause.
" (D) The advisory committee referred to in subparagraph
(C) of this paragraph shall be composed of experts selected
by the National Academy of Sciences, qualified in the subject
matter referred to the committee and of adequately diversified
professional background, except that in the event of the in-
ability or refusal of the National Academy of Sciences to act,
the Secretary shall select the members of the committee. The
size of the committee shall be determined by the Secretary.
Members of an advisory committee shall receive as compen-
sation for their services a reasonable per diem, which the
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STATUTES AND LEGISLATIVE HISTORY 613
Secretary shall by rules and regulations prescribe, for time
actually spent in the work of the committee, and shall in
addition be reimbursed for their necessary traveling and
subsistence expenses while so serving away from their places
of residence. The members shall not be subject to any other
provisions of law regarding the appointment and compensa-
tion of employees of the United States. The Secretary shall
furnish the committee with adequate clerical and other assis-
tance, and shall by rules and regulations prescribe the pro-
cedure to be followed by the committee.
(9) On page 17, line 5, immediately after "health" insert the
following:
Provided, That, with respect to any use in or on food for
which a listed color additive is deemed to be safe by reason
of the proviso to paragraph (4) of subsection (b), the require-
ment of certification shall be deemed not to be necessary in
the interest of public health protection.
[p. 3]
(10) On page 17, line 13, immediately after "shall" insert the
following:
, subject to the provisions of subparagraph (C) of subsection
(b) (5) of this section,
(11) On page 17, lines 16 and 17, stike out "subsections (b),
(c),or (e)" and insert in lieu thereof "subsection (b) or (c)".
(12) On page 17, immediately below line 20, insert the following:
" (1) if the proceeding is commenced by the filing of a peti-
tion, notice of the proposal made by the petition shall be
published in general terms by the Secretary within thirty
days after such filing, and the Secretary's order required by
paragraph (1) of section 701 (e)) acting upon such proposal
shall, in the absence of prior referral (or request for referral)
to an advisory committee, be issued within ninety days after
the date of such filing, except that the Secretary may (prior
to such ninetieth day), by written notice to the petitioner,
extend such ninety-day period to such time (not more than
one hundred and eighty days after the date of filing of the
petition) as the Secretary deems necessary to enable him to
study and investigate the petition;
"(2) any report, recommendations, underlying data, and
reasons certified to the Secretary by an advisory committee
appointed pursuant to subparagraph (D) of subsection (b)
(5) of this section, shall be made a part of the record of any
hearing if relevant and material, subject to the provisions of
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614 LEGAL COMPILATION—PESTICIDES
section 7(c) of the Administrative Procedure Act (5 U. S. C.,
sec. 1006 (c)). The advisory committee shall designate a mem-
ber to appear and testify at any such hearing with respect to
the report and recommendations of such committee upon
request of the Secretary, the petitioner, or the officer conduct-
ing the hearing, but this shall not preclude any other member
of the advisory committee from appearing and testifying at
such hearing;
(13) On page 19, line 1, strike out "(1)" and insert in lieu
thereof "(3)".
(14) On page 19, line 5, strike out "(2)" and insert in lieu
thereof " (4)".
(15) On page 25, line 14, strike out "Regulations" and insert
in lieu thereof:
Except as provided in subparagraph (C) of this paragraph,
regulations
(16) On page 25, line 23, immediately after the period insert
the following:
Regulations providing for fees (and advance deposits to cover
fees), which on the day preceding the enactment date were
in effect pursuant to section 706 of the basic Act, shall be
deemed to be regulations under such section 706 as amended
by this Act, and appropriations of fees (and advance depos-
its) available for the purposes specified in such section 706
[p. 4]
as in effect prior to the enactment date shall be available for
the purposes specified in such section 706 as so amended.
(B) If the Secretary, by regulation—
(i) has terminated a provisional listing (or deemed
provisional listing) of a color additive or particular use
thereof pursuant to paragraph (1) (E) of this subsec-
tion ; or
(ii) has, pursuant to paragraph (1) (C) or paragraph
(3) of this subsection, initially established or rendered
more restrictive a tolerance limitation or other restriction
or requirement with respect to a provisional listing (or
deemed provisional listing) which listing had become
effective prior to such action,
any person adversely affected by such action may, prior to the
expiration of the period specified in clause (A) of subsection
(a) (2) of this section, file with the Secretary a petition for
amendment of such regulation so as to revoke or modify such
action of the Secretary, but the filing of such petition shall not
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STATUTES AND LEGISLATIVE HISTORY 615
operate to stay or suspend the effectiveness of such action.
Such petition shall, in accordance with regulations, set forth
the proposed amendment and shall contain data (or refer to
data which are before the Secretary or of which he will take
official notice), which show that the revocation or modification
proposed is consistent with the protection of the public health.
The Secretary shall, after publishing such proposal and afford-
ing all interested persons an opportunity to present their
views thereon orally or in writing, act upon such proposal by
published order.
(C) Any person adversely affected by an order entered
under subparagraph (B) of this paragraph may, within thirty
days after its publication, file objections thereto with the
Secretary, specifying with particularity the provisions of the
order deemed objectionable, stating reasonable grounds for
such objections, and requesting a public hearing upon such
objections. The Secretary shall hold a public hearing on such
objections and shall, on the basis of the evidence adduced at
such hearing, act on such objections by published order. Such
order may reinstate a terminated provisional listing, or
increase or dispense with a previously established temporary
tolerance limitation, or make less restrictive any other limita-
tion established by him under paragraph (1) or (3) of this
subsection, only if in his judgment the evidence so adduced
shows that such action will be consistent with the protection
of the public health. An order entered under this subpara-
graph shall be subject to judicial review in accordance with
section 701 (f) of the basic Act except that the findings and
order of the Secretary shall be sustained only if based upon
a fair evaluation of the entire record at such hearing. No stay
or suspension of such order shall be ordered by the court
pending conclusion of such judicial review.
(17) On page 28, line 6, strike out "(B)" and insert in lieu
thereof "(D)".
[p. 5]
(18) On page 28, line 20, strike out "paragraph (1) (A) and
(C)" and insert in lieu thereof "paragraphs (1) (A) and (C) of
this subsection".
(19) On page 29, line 15, immediately after "product" insert
the following: "poultry or poultry product,".
PURPOSE OP 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
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616 LEGAL COMPILATION—PESTICIDES
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,
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
certification) 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
established 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.
BACKGROUND INFORMATION
Under the Federal Food, Drug, and Cosmetic Act the treatment
of color additives differs radically as between so-called coal-tar
colors and other colors.
1. Coal-tar colors.—The term "coal-tar color" has been inter-
preted to apply not only to substances which are coal-tar deriva-
tives but also to synthetic substances so related in their chemical
structure to a coal-tar constituent as to be capable of derivation
therefrom even when not actually so derived.
[P. 6]
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STATUTES AND LEGISLATIVE HISTORY 617
So-called coal-tar colors are regulated under the act through
similar sets of provisions in chapters IV (food), V (drugs), and
VI (cosmetics). The act requires the Secretary of Health, Educa-
tion, and Welfare to provide by regulation for listing and certify-
ing batches of "coal-tar colors which are harmless and suitable for
use" in food, drugs, and cosmetics.
Food containing a coal-tar color is deemed adulterated under
section 402 (c) of the act unless the color is from a bath certified
by the Secretary under section 406. Section 406 (b) then directs
the Secretary to provide for listing coal-tar colors that are harm-
less 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 cosmetic (other than a hair dye, which is defined to exclude
eyelash and eyebrow dyes) containing a coal-tar color is deemed
adulterated by section 601 (e) unless the color is from a batch
certified by the Secretary under section 604. Section 604 then
directs the Secretary to provide for listing of coal-tar colors that
are harmless and suitable for use in cosmetics, and for certifying
batches of such colors.
The Secretary of Health, Education, and Welfare is without
authority to admit a coal-tar color to listing under tolerance limi-
tations ; it must be harmless per se in order for the Secretary to
admit it to listing (Flemming v. Florida Citrus Exchange, 358
U.S. 153 (1958)).
One exception to the prohibition against the listing of a coal-tar
color under tolerance limitations was made by the Congress in
Public Law 86-2 to permit the temporary listing and certification
of the color Citrus Red No. 2 for the coloring of mature oranges
under tolerances found to be safe by the Secretary of Health, Edu-
cation, and Welfare.
2. Other colors.—A coloring material not classified as a coal-tar
color is not subject to any pretesting, listing, or certification
requirements 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.
Non-coal-tar coloring materials used in food, when such mate-
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618 LEGAL COMPILATION—PESTICIDES
rials are not generally recognized by experts as safe, are classified
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 to be
adulterated if the additive is unsafe within the meaning of section
409. Under section 409 the food additive is deemed unsafe unless
it and its use, or intended use, conform to a regulation issued by
the Secretary announcing the conditions, including the establish-
ment of tolerance limitations, under which the additive may be
safely used. Food colors which were in commercial use before Janu-
ary 1,1958, are allowed a grace period not later than March 6,1961,
for compliance with the provisions of the Food Additives Amend-
ment of 1958. Such "food additive" colors, however, are not sub-
ject to any requirement of "batch" certification.
[p. 7]
NEED FOE LEGISLATION
The principal reasons which give rise to the need for this legis-
lation may be summarized as follows:
1. The law with respect to coal-tar colors — and this comprises
most synthetic colors — is not in consonance with modern concepts
of consumer protection, in that it does not allow the Secretary of
Health, Education, and Welfare to list a color for safe use under
regulations which place a limit on the amount of a color that may
be used on an article and to establish other conditions of use. For
food, and for drugs and cosmetics other than those externally
applied, the Secretary must ban the use of such a color completely,
as not being "harmless," if it is found to be toxic in the laboratory
when fed to animals in some concentrations, even though its actual
level and manner of use may be completely safe. For externally
applied drugs and cosmetics, the same principle applies if toxicity
appears in the laboratory in some concentrations by any relevant
type of test, even though its actual level and manner of use may
be wholly safe.
Prior to delisting proceedings by the Department of Health,
Education, and Welfare there were 19 colors listed for unrestricted
use in food, drugs, and cosmetics, 69 colors listed for unrestricted
use in drugs and cosmetics, and 30 colors listed for use only in
externally applied drugs and cosmetics, a total of 118 straight
colors listed for certification. Seven colors have been removed from
the food, drug, and cosmetic list and have been relisted for external
use in drugs and cosmetic colors, so that we now have 12 food,
drug, and cosmetic colors, 69 unrestricted drug and cosmetic colors,
and 37 drug and cosmetic colors for external use. The Department
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STATUTES AND LEGISLATIVE HISTORY 619
has proposed that other colors be removed from listing and certi-
fication.
The principle of allowing colors to be used under tolerance limi-
tations was endorsed, in 1956, by a committee of recognized scien-
tists appointed by the National Academy of Sciences to review
the coal-tar color research program of the Food and Drug Admin-
istration, as indicated by the following excerpt from the Commit-
tee's report:
This Committee feels compelled to indicate that certifica-
tion of a compound as "harmless and suitable for use" in food,
drugs, and cosmetics as required under present law is unreal-
istic unless the level of use is specified (Report of the National
Academy of Sciences-National Research Council Ad Hoc
Advisory Committee to Review the Food and Drug Adminis-
tration's Research Program on Coal-tar Dyes, June 1956).
2. The theoretically "perfect" public health protection once
thought to be accorded by the present law regarding coal-tar colors
has turned out to be in fact inadequate. While, theoretically, only
"harmless" colors may be listed, a retesting program of the Food
and Drug Administration, employing the most modern testing
techniques, has led to the discovery that many of the so-called col-
ors on the list may in fact be toxic in some concentrations. Yet,
the Secretary of Health, Education, and Welfare cannot take a
particular color off the list until he establishes its toxicity by lab-
oratory tests, a process which for the list as a whole may take as
much as 20 years. Under the bill, there would, in general, be a
maximum of 2Va years during which the retesting process for the
[P. 8]
established colors would have to be completed—primarily by indus-
try—and during which the Secretary could establish temporary
tolerance limitations, at zero level if necessary, to protect the pub-
lic health. This maximum period could be extended only where, in
a particular case, such extension is necessary to complete the
required safety tests for a color and is found consistent with pro-
tection of the public health.
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
certification 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
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620 LEGAL COMPILATION—PESTICIDES
requirement for non-coal-tar color additives as such, other than
food additives.
4. Unless the law, as proposed by the bill, is brought into con-
formity with modern methods of control by incorporation of the
safe-for-use principle, it will become increasingly difficult, and may
eventually become impossible, to find permissible colors to supply
the demand for various important color uses on the part of consum-
ers as well as the food, drug, and cosmetic industries. From the
standpoint of the public interest there is no compensating advan-
tage for the inflexibility of the present law in this respect.
The food, drug, cosmetic, and color industries find themselves in
a serious situation as the result of the removal of color after color
from the lists under the present inflexible provisions of the law.
Unless the law, by permitting the listing of colors under safe tol-
erances, is brought into line with present-day methods of control,
the emergency will grow and deepen, an emergency which the Sec-
retary of Health, Education, and Welfare believes could be relieved
for most established colors on a sound and permanent basis by
enacting the provisions of this bill without in any way conflicting
with the need for adequate protection of the public health.
There is no justification, from the point of view of the public
interest, in driving either color manufacturers or food, drug, or
cosmetic producers, dependent upon the use of color, out of busi-
ness where the particular use of color involved is one which can
safely be admitted under proper conditions of use (including toler-
ance limitations and certification requirements) established by the
Department of Health, Education, and Welfare.
The scientifically sound principle that we must consider condi-
tions of use when passing on suitability and safety of a color addi-
tive has recently been approved by Congress in temporary emer-
gency legislation (Public Law 86-2) with respect to one coal-tar
color, i.e., citrus red No. 2 for use in coloring mature oranges, after
previous adoption of the "safe-for-use" principle in the Food Addi-
tives Amendment of 1958 (Public Law 85-929). In reporting upon
the emergency legislation for citrus red No. 2, this committee said:
It is specifically provided that the provisions of this bill
will become inoperative on August 31, 1961, or before that
time if general legislation affecting coloring materials for
food is enacted by the Congress. The reason for the time limit
is that this is emergency legislation, which will meet the imme-
diate needs of the citrus industry without permanently
engrafting on the basic Food, Drug, and Cosmetic Act a new
[p. 9]
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STATUTES AND LEGISLATIVE HISTORY 621
principle of tolerances for coal-tar colors which is not appli-
cable to foods generally. The expiration date has been so fixed
as to allow the Congress ample time to consider the applica-
tion of this principle to all foods.
It is the intention of the committee as soon as feasible to
study amendments to the Federal Food, Drug, and Cosmetic
Act dealing with color additives generally, since the need for
such legislation has been amply demonstrated to this commit-
tee (86th Cong., 1st sess., H. Kept. 88).
The bill—by permitting, for a reasonable period, the provisional
listing and certification of heretofore commercially established
colors, under temporary tolerances where necessary for public-
health protection, pending the development of the scientific data
required for a definitive determination as to the listing of these
colors under the permanent provisions of the bill—would permit an
orderly transition to the control procedures of the bill. At the same
time, the bill would establish on a permanent basis a sound system
of color regulation fully protective of consumer interests.
EXPLANATION OF COMMITTEE BILL
The committee 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 safely be used in foods, drugs, or cosmetics, sub-
ject, 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.
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 term "food additive"; repealing the present provisions for list-
ing 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 certification (or
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622 LEGAL COMPILATION—PESTICIDES
exemption from certification) ; and making other amendments to
the act to mesh with these provisions.
The bill would embrace all color additives whether or not syn-
thesized 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
[p. 10]
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 colors
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
was forcefully brought to the attention of Congress by the inves-
tigations and recommendations of the House Select Committee to
Investigate the Use of Chemicals in Foods and Cosmetics, the
Delaney committee in the 82d Congress, and by the hearings cul-
minating in the enactment 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 deter-
mined to be necessary to assure the safety of such use.
3. Delaney anticancer clause.—One provision of the bill which
aroused considerable controversy in the hearings on this legisla-
tion is proposed section 706 (b) (5) (B) appearing on page 11, line
8, of the reported bill, and often referred to as the Delaney anti-
cancer clause.
This clause provides that a color additive shall be deemed unsafe
and shall not be listed for any use which will or may result in
ingestion of all or any part of such additive if the additive is found
to induce cancer when ingested by man or animal, or if it is found
to induce cancer in man or animal by other tests, not involving
ingestion, which are considered to be appropriate for the evalua-
tion of the safety of additives for use in food.
This clause also provides that a color additive shall be deemed
unsafe and shall not be listed for any use which will not result in
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STATUTES AND LEGISLATIVE HISTORY 623
ingestion of any part of such additive if, after tests which are
appropriate for the evaluation of the safety of the additive for such
use, or after other relevant exposure of man or animal to such
additive, it is found by the Secretary to induce cancer in man or
animal.
A similar anticancer clause is included in the Food Additives
Amendment of 1958 to the Federal Food, Drug, and Cosmetic Act
(Public Law 85-929).
There are many unknowns about cancer that are yet to be solved.
We do know, however, that today cancer is second only to heart
disease as a cause of death among the American people. Every
year, approximately 250,000 people die of cancer in this country.
Approximately 450,000 new cases of cancer are discovered each
year. At any given time about 700,000 persons are under treat-
ment for cancer.
Expert testimony before the committee showed that scientific
inquiry into the incidence of cancer among certain occupational
groups has been traced, in several instances, to specific substances
involved in their environment. Laboratory experiments have shown
that a number of substances when added to the diet of test animals
have produced cancers of various kinds in the test animals. It is
this fact—namely, that small quantities of certain materials over
a period of time will cause abnormal cell growth in animals—that
gave rise to the Delaney anticancer clause in the Food Additives
Amendment.
[p. 11]
The Secretary of Health, Education, and Welfare very strongly
urged the retention of the Delaney clause in the reported bill. The
reason for his position may be summarized from his statement to
the committee as follows :
The preponderance of scientific evidence clearly dictates
our position: Our advocacy of the anticancer proviso in the
proposed color additives amendment is based on the simple
fact that no one knows how to set a safe tolerance for sub-
stances in human foods when those substances are known to
cause cancer when added to the diet of animals. I should like
to underline again one statement in particular which I read
earlier from the summary of Dr. [G. Burroughs] Mider's
review of the role of certain chemical and physical agents in
relation to cancer. It is this:
'Wo one at this time can tell how much or how little of a
carcinogen would be required to produce cancer in any human
being, or how long it would take the cancer to develop."
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624 LEGAL COMPILATION—PESTICIDES
This is why we have no hesitancy in advocating- the inclu-
sion of the anticancer clause.
Unless and until there is a sound scientific basis for the
establishment of tolerances for carcinogens, I believe the
Government has a duty to make clear—in law as well as in
administrative policy—that it will do everything possible
to put persons in a position where they will not unnecessarily
be adding residues of carcinogens to their diet.
The population is inadvertently exposed to certain carcino-
gens. Ultraviolet light occurs in sunlight. The burning of most
fuels produces some minute quantities of chemical compounds
that elicit cancer in experimental animals, and some of the
same agents can be identified in soot, tars, dusts, and similar
residues—even from the atmosphere. In view of these facts,
it becomes all the more imperative to protect the public from
deliberate introduction of additional carcinogenic materials
into the human environment.
Whenever a sound scientific basis is developed for the estab-
lishment of tolerances for carcinogens, we will request the
Congress to give us that authority. We believe, however, that
the issue is so important that the elected representatives of
the people should have the opportunity of examining the evi-
dence and determining whether or not the authority should be
granted.
Many have oftentimes expressed the fond hope that the
day is not far distant when we shall be able to control cancer.
A dramatic breakthrough in this sense may never come.
Rather, the progress—looked at from the standpoint of reduc-
ing the number of cases of cancer—may come only as we are
willing to give heed to the kind of leads that are incorporated
in the document prepared by Dr. Mider. It is clear that if we
include in our diet substances that induce cancer when
included in the diet of test animals, we are taking a risk. In
the light of the rising number of cases of cancer, why should
we take that risk? Why shouldn't the Government do every-
[p- 12]
thing possible to see to it that we do not involuntarily take
that risk?
*******
This, I believe, is as far as our discretion should go in the
light of present scientific knowledge. We have no basis for
asking Congress to give us discretion to establish a safe tol-
erance for a substance which definitely has been shown to
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STATUTES AND LEGISLATIVE HISTORY 625
produce cancer when added to the diet of test animals. We
simply have no basis on which such discretion could be exer-
cised because no one can tell us with any assurance at all
how to establish a safe dose of any cancer-producing sub-
stance.
Unless and until cancer research makes a breakthrough at
this point, the principle in the anticancer clause is sound.
(Statement by Hon. Arthur S. Flemming, Secretary of Health,
Education, and Welfare, before the House Committee on Inter-
state and Foreign Commerce, January 26, 1960.)
The Secretary further stated that, even if the Delaney clause is
deleted from the bill, he believes that he has the authority to apply
the policy that is reflected in that clause but he urged the Congress
to join with the executive branch in giving added assurance to the
public by including the anticancer clause in the proposed color
additives legislation.
The committee heard a large number of witnesses on the anti-
cancer clause, including a distinguished panel of scientific experts
on cancer selected by Dr. Detlev W. Bronk, President of the
National Academy of Sciences.
One industry witness objected to any anticancer clause. Another
witness argued that it is possible to establish safe tolerance levels
for substances that produce cancer when fed to test animals. Some
would have the ban on cancer producers apply only to colors that
induce cancer when ingested in an amount and under conditions
reasonably related to their intended use. And another witness pro-
posed that the cancer clause be taken out of its present position in
the bill and added with material language changes to section
705 (b) (5) (A) so that it would become simply one of the factors
for the Secretary to consider in evaluating the safety of a color
additive.
It is evident that such proposed changes are intended to give the
Secretary the right to establish tolerances for presumed safe levels
of colors that produce cancer when tested under appropriate lab-
oratory conditions. Thus, any of the proposals, if adopted, would
weaken the present anticancer clause in the reported bill. For this
reason all of the proposed changes were rejected by the committee.
The panel discussed in considerable detail the scientific problems
that confront us in connection with determination of the cancer-
producing potential of chemicals. They pointed out the difficulties
of designing and conducting an experiment to determine whether
a substance is a cancer producer for man and the difficulties in
evaluating the test data after they are obtained.
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626 LEGAL COMPILATION—PESTICIDES
Some of the panel members have suggested that despite these
difficulties, in extraordinary cases, the Secretary of Health, Edu-
cation, and Welfare should have the authority to decide that a
minute amount of a cancer-producing chemical may be added to
[P. 13]
man's food after a group of scientists consider all the facts and
conclude that the quantity to be tolerated is probably without
hazard.
In commenting on this testimony, the Secretary of Health, Edu-
cation, and Welfare said:
The Department's position is that the proposed color addi-
tives legislation should include an anticancer clause that
makes illegal the use of any color that will induce cancer when
tested by appropriate methods. We believe this position to
be the only sound public policy in view of the fact that our
experts tell us present scientific techniques do not permit them
to state unequivocally how much or how little of a substance
that induces cancer when administered to animals will induce
cancer when administered to man.
*******
The rallying point against the anticancer provision is the
catch phrase that it takes away the scientist's right to exercise
judgment. The issue thus made is a false one, because the
clause allows the exercise of all the judgment that can safely
be exercised on the basis of our present knowledge. The clause
is grounded on the scientific fact of life that no one, at this
time, can tell us how to establish for a man a safe tolerance
for a cancer-producing agent. Until cancer research makes
a breakthrough at this point, there simply is no scientific
basis on which judgment or discretion could be exercised in
tolerating a small amount of a known carcinogenic color or
food additive. As I pointed out in my original testimony, the
opposition to inclusion of an anticancer clause arises largely
out of a misunderstanding of how this provision works. It
allows the Department and its scientific people full discretion
and judgment in deciding whether a substance has been shown
to produce cancer when added to the diet of test animals. But
once this decision is made, the limits of judgment have been
reached and there is no reliable basis on which discretion could
be exercised in determining a safe threshold dose for the
established carcinogen.
So long as the outstanding experts in the National Cancer
Institute and the Food and Drug Administration tell us that
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STATUTES AND LEGISLATIVE HISTORY 627
they do not know how to establish with any assurance at all
a safe dose in man's food for a cancer-producing substance,
the principle in the anticancer clause is sound (statement by
Hon. Arthur S. Flemming, Secretary of Health, Education,
and Welfare before the House Committee on Interstate and
Foreign Commerce, May 9, 1960).
In view of the uncertainty surrounding the determination of
safe tolerances for carcinogens, the committee decided that the
Delaney anticancer provision in the reported bill should be retained
without change.
The committee adopted an amendment, discussed below, which
provides for an ad hoc advisory committee to study and report on
the question of whether a color additive is a carcinogen.
[p. 14]
4. Comprehensive lists.—The bill retains the approach of the
present coal-tar color provisions in providing for comprehensive
lists of colors, instead of attempting to carve out an exception from
listing for colors "generally recognized" by experts as 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 Gov-
ernment to prove that an additive is not generally recognized as
safe before the safety clearance procedure applies—in view of the
broad sweep of the amendment, which otherwise would have cov-
ered such additives as salt, vinegar, and natural spices—the Secre-
tary of Health, Education, and Welfare does not believe that such
an exception is sound in the case of color additives, whether they
be extracted from a natural source or synthesized. If a color is
in fact generally recognized by competent experts as safe for unre-
stricted use in any kind of article, this can be readily established
and reflected in regulations listing such color. It may be noted,
however, that a committee amendment to the bill deems a color
additive to be suitable and safe for the purpose of listing for use
generally in food, where there is in effect a published finding of the
Department that the substance is generally recognized as safe for
its intended use within the meaning of the provisions exempting
such substances from the Food Additives Amendments of 1958.
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
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
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628 LEGAL COMPILATION—PESTICIDES
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, especially
since the coverage of the law is broadened to include all types of
substances capable of imparting color.
6. Effective date and transitional provisions.—The amendments
made by the bill to the Federal Food, Drug, and Cosmetic Act—
i.e., 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
certified prior to the date of enactment of the bill, and (b) those
non-coal-tar colors, and synthetic beta-carotene, which were com-
mercially used or sold prior to that date for food, drug, or cos-
metic use.
Provisional listings would be subject to appropriate temporary
tolerance limitations and other conditions of use when deemed
necessary for the protection of the public health during the period
of provisional listing. The bill would permit establishment of a zero
[p. 15]
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 of Health,
Education, and Welfare.
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
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STATUTES AND LEGISLATIVE HISTORY 629
to those colors and uses thereof for which the data available 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 y% -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.
7. Deception.—A witness before the committee suggested amend-
ing proposed section 706 (b) (6) to add the word "harmful" before
the word "deception" so as to provide that the Secretary shall not
list a color additive for a proposed use if the data before him show
that such proposed use would "promote harmful deception of the
consumer in violation of this Act or would otherwise result in mis-
branding or adulteration within the meaning of this Act."
The Federal Food, Drug, and Cosmetic Act prohibits, among
other things, the introduction of an adulterated or misbranded
food, drug, or cosmetic into interstate commerce, or the adultera-
tion of misbranding of any food, drug, device, or cosmetic in inter-
state commerce, or while held for sale after interstate shipment.
Furthermore, the food additives amendment (sec. 409 (c) (3) (B)
of the act) specifically prohibits the Secretary from issuing a regu-
lation prescribing the conditions under which a food additive may
be safely used if a fair evaluation of the data before him shows
that the proposed use of the additive would "promote deception of
the consumer in violation of this Act or would otherwise result in
adulteration or in misbranding of food within the meaning of
this Act."
The committee is of the opinion that it would be unsound policy
to legislate against deception of the consumer in the food additives
law and against harmful deception of the consumer in the color
additives law. Obviously, the provision against deception of the
consumer should be identical under both sections of the law. It
should be emphasized that we are dealing here solely with decep-
tion which would violate the law. Among the relevant provisions
of the Food and Drug Act aimed at deception are those which deem
[p. 16]
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630 LEGAL COMPILATION—PESTICIDES
a food to be adulterated—
(3) if damage or inferiority has been concealed in any
manner; or (4) if any substance has been added thereto or
mixed or packed therewith so as to increase its bulk or weight,
or reduce its quality or strength, or make it appear better or
of greater value than it is (sec. 402(b) (3) and (4) of the
Federal Food, Drug, and Cosmetic Act).
Examples of coloring practices that would promote deception of
the consumer in violation of the basic act were cited by the Secre-
tary of Health, Education, and Welfare as follows: (1) the use of
artificial color in egg noodles to hide a deficiency in eggs, (2) the
use of artificial color on immature apples or oranges to make the
fruit appear mature, (3) the use of artificial color in tomato catsup
or juice or canned tomatoes prepared from immature raw mate-
rials, and (4) the use of artificial color in stale red meat to make
it appear fresh.
The Secretary of Health, Education, and Welfare, by letter dated
April 21, 1960, has advised the committee that use of artificial
coloring, under proper labeling declaration, on mature oranges
would not promote deception in violation of the Federal Food,
Drug, and Cosmetic Act. Likewise, the Food and Drug Adminis-
tration, by letter dated June 2, 1960, has advised the committee
that the use of safe coloring in oleomargarine or margarine, with
appropriate label declaration, or in butter would not promote
deception in violation of the act. These letters are included in the
appendix to this report.
(8) Recommended amendments to Food Additives Amendment.—
The Secretary of Health, Education, and Welfare recommended
the adoption of two amendments to the Food Additives Amend-
ment of 1958. These proposed amendments are:
(1) A modification of the Delaney anticancer clause to pro-
vide that additives used in animal feed which do not adversely
affect the animal and which leave no residue either in the ani-
mal after slaughter, or in any food product obtained from the
living animal, be exempt from the provisions of the clause.
The Secretary also suggested a corresponding change with
respect to color additives.
" (2) A modification of the "prior sanction or approval"
(grandfather) clause (sec. 201 (s) (3) of the act).
The Secretary's letter of May 13, 1960, submitting these amend-
ments is included in the appendix to this report.
The committee did not consider the above-mentioned amend-
ments because they involved amendments to the food additive
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STATUTES AND LEGISLATIVE HISTORY 631
amendments which are not directly germane to this bill. They may
be considered at a later date.
EXPLANATION OF PRINCIPAL COMMITTEE AMENDMENTS
(1) Agricultural chemicals affecting color (p. 3, beginning on
line 10 of reported bill)
The committee was advised that certain pesticide chemicals used
in fruit production have the effect not only of protecting the trees
against plant diseases but also of supporting or otherwise affecting
natural plant processes which thus result in the production of bet-
ter color and finish in the fruit. Also, some plant growth regula-
[P- 17]
tors, when applied to plants, likewise enhance the development of
normal color in the produce of such plants. Some fear has been
expressed that such chemicals and plant regulators could be con-
sidered to fall within the scope of the definition of "color additive"
in section 101 (c) of the bill since they have the ability to promote
the coloring of raw agricultural commodities.
The committee agrees with the Secretary of Health, Education,
and Welfare that such chemicals and plant nutrients are not color
additives within the meaning of the basic definition of color addi-
tive in this bill, since they merely promote the development of the
natural color of produce as the result of the normal physiological
processes of the plant or produce. To make this clear, however, the
committee has inserted an amendment to the effect that the term
"color additive" in section 101 (c) of the bill shall not be construed
to apply to any pesticide chemical, soil or plant nutrient, or other
agricultural chemical which affects the color of fruit or other raw
agricultural commodity which is the produce of the soil solely
through its effect on plant metabolism or enzymatic processes
either before or after harvest. Pesticide chemicals are regulated
under section 408 of the Federal Food, Drug, and Cosmetic Act
and under the Federal Insecticide, Fungicide, and Rodenticide Act
(61 Stat. 163; 7 U.S.C. 135—135k), and there is no necessity for
subjecting them to additional regulation under the color additive
amendments when their sole effect on color is through such meta-
bolic or enzymatic processes.1
It is not the intention of the committee, however, to exempt from
the provisions of this bill any chemical or nutrient if it also con-
tains a dye, pigment, or other substance whose function is to
1 Under a recent amendment to the Federal Insecticide, Fungicide, and Rodenticide Act (Public
Law 86-139) nematocides, plant regulators, defoliants, and desiccants have been classified as
pesticide chemicals.
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632 LEGAL COMPILATION—PESTICIDES
impart color to the fruit or other raw agricultural commodity.
The views of the Secretary of Health, Education, and Welfare
in letters to the committee dated February 8, 1960, and April 21,
1960, and the letter of the Assistant Secretary of Agriculture dated
April 14, 1960, expressing their views on this subject, in which
the committee concurs, are shown in the appendix to this report.
(2) Color additives exempted under Food Additives Amendment
(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, without
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 requirement
that there be practicable methods for determining the identity and
quantity of any substance formed in or on food because of the use
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STATUTES AND LEGISLATIVE HISTORY 633
of a color additive, could not always be met in the present state of
knowledge and that, in those cases in which there is no need for
such a method of analysis for adequate public health protection,
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.
(4) Ad Hoc Scientific Advisory Committee on Carcinogenicity of
Additive (p. 11, beginning on line 21 of reported bill)
This committee amendment provides that in any proceeding for
the issuance, amendment, or repeal of a regulation by the Secre-
tary of Health, Education, and Welfare listing a color additive, any
person who will be adversely affected may request that the petition
or order thereon or the Secretary's proposal which is the subject
of the proceeding be referred to an advisory committee for a report
and recommendations with respect to any matter arising under
proposed section 706(b) (5) (B) of the bill, commonly referred to
as the Delaney anticancer clause, if such matter is involved in such
proposal or order and requires the exercise of scientific judgment.
Upon such request, the Secretary shall forthwith appoint an
advisory committee and shall refer to it for study and for a report
and recommendations the question arising under section 706 (b)
(5) (B). The Secretary may also refer such a matter to such an
advisory committee on his own initiative. The petitioner as well as
representatives of the Department of Health, Education and Wel-
fare shall have the right to consult with the advisory committee.
The request for referral, or the Secretary's referral on his own
initiative, may be made at any time before, or within 30 days after,
publication of the Secretary's order acting upon the petition or
proposal.
Within 60 days after the referral date or within an additional
30 days if necessary, the advisory committee shall certify to the
Secretary a report and recommendations. Within 30 days after
such certification, and after giving due consideration to all the
information before him, including the report, the Secretary shall
by order confirm or modify any order theretofore issued, or if no
such prior order has been issued, he shall by order act upon the
petition or other proposal.
[P. 19]
Where by reason of section 706 (b) (5) (B) the Secretary has
initiated a proposal to remove from listing a color additive previ-
ously listed and a request has been made for referral of such a
proposal to an advisory committee, the Secretary may not act by
order on such proposal until the advisory committee has made a
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634 LEGAL COMPILATION—PESTICIDES
report and recommendations and he has considered such recom-
mendations unless the Secretary finds that emergency conditions
exist necessitating the issuance of an order.
The committee intends by the term "emergency conditions" to
mean, in general, a condition which requires immediate action in
order to avoid imminent hazard to public health.
The advisory committee shall be composed of experts selected by
the National Academy of Sciences, qualified in the subject matter
referred to the committee and of adequately diversified professional
background. In the unlikely event that the National Academy of
Sciences is unable or refuses to act, the Secretary shall select the
members of the advisory committee. The size of the committee
shall be determined by the Secretary.
Any report, recommendations, underlying data, and reasons
certified to the Secretary by such advisory committee shall be made
a part of the record of any hearing if relevant and material, subject
to the provisions of section 7(c) of the Administrative Procedures
Act (5 U.S.C. 1006 (c)) (p. 18, beginning on line 11 of reported bill).
The advisory committee shall designate a member to appear and
testify at any such hearing with respect to the report and recom-
mendations of such committee upon request of the Secretary, the
petitioner, or the officer conducting the hearing, but this shall not
preclude any other member of the advisory committee from appear-
ing and testifying at such hearing (p. 18, beginning on line 17 of
reported bill).
(5) Color additive deemed to be safe under the proviso in section
706(b)(4) need not be certified (p. 17, beginning on line 5 of
reported bill)
This committee amendment provides that any color additive
which has been listed as suitable and safe for use generally in or
on food by reason of the proviso in proposed section 706 (b) (4),
discussed above, need not be certified by the Secretary under
proposed section 706 (c) in this bill.
(6) Time schedule governing action on a petition (p. 17, beginning
on line 21 of reported bill)
This committee amendment sets up a time schedule governing
the action on a petition to the Secretary for the issuance, amend-
ment, or repeal of a regulation, except where matters are referred
to an advisory committee. As stated above, a separate time schedule
is prescribed for cases involving advisory committees.
Notice of the proposal made by a petition must be published in
general terms by the Secretary within 30 days after filing, and the
Secretary's order acting upon such proposal shall be issued within
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STATUTES AND LEGISLATIVE HISTORY 635
90 days after the date of the filing of the petition. The Secretary
may extend the 90-day period up to but not exceeding 180 days as
he deems necessary to enable him to study and investigate this
petition. This is the same time schedule as is provided in the Food
Additives Amendment of 1958.
[P. 20]
(7) Review of regulation by Secretary terminating or placing a
tolerance limitation on a provisional listing (p. 26, beginning
on line 7 of reported bill)
This committee amendment provides that if the Secretary of
Health, Education, and Welfare has, by regulation issued pursuant
to the transitional provisions of this legislation, terminated a provi-
sional listing (or deemed provisional listing) of a color additive
or a particular use thereof, or if he has established, or made more
restrictive, a tolerance limitation or other restriction or require-
ment with respect to an already effective provisional listing, any
person who may be adversely affected by such action may petition
the Secretary for an amendment to revoke or modify such action,
but such petition will not operate to stay or suspend the effective-
ness of such action. The Secretary must afford all interested
persons an opportunity to present their views on the proposal of
the petition after which the Secretary shall act on the petition
by published order.
Any person adversely affected by this order may, within 30 days,
file objections thereto, state reasonable grounds therefor, and
request a public hearing upon such objections which shall be grant-
ed. Based on the evidence adduced at such hearing, the Secretary
shall issue an order which may reinstate a terminated provisional
listing or alter a previously established temporary tolerance limita-
tion, or alter any other limitation established by him, only if in his
judgment the evidence shows that such action will be consistent
with the protection of the public health. Such order shall be subject
to judicial review in accordance with section 701 (f) of the Federal
Food, Drug, and Cosmetic Act except that the findings and order of
the Secretary shall be sustained only if based upon a fair evaluation
of the entire record at such hearing. The court may not stay or
suspend the Secretary's order pending conclusion of judicial review.
REPORTS FROM EXECUTIVE DEPARTMENTS AND AGENCIES
The reports from the various executive departments and agen-
cies on H. R. 7624 (S. 2197) are found in the appendix to this report.
The Secretary of Health, Education, and Welfare estimated the
cost of enforcing this legislation to be approximately $1 million
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636 LEGAL COMPILATION—PESTICIDES
during the first year of operation and close to $900,000 a year
thereafter. The details on this estimate are contained in the Secre-
tary's letter of May 29, 1959, reproduced in the appendix to this
report.
SECTION-BY-SECTION ANALYSIS OF "COLOR ADDITIVE AMENDMENTS
OF 1960"
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
[p. 21]
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
eyebrow dyes) containing a coal-tar color is deemed adulterated
by section 601 (e) unless the color is from a batch certified by the
Secretary 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 under existing law
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, the food additive is deemed unsafe un-
less it and its use (or intended use) conform to a regulation under
section 409 announcing 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 provisions
for the listing and certification of "harmless" coal-tar colors (sees.
406(b), 504, and 604) ; enacts new, integrated provisions for the
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STATUTES AND LEGISLATIVE HISTORY 637
separate listing of suitable "color additives" safe for use in food,
drugs, or cosmetics, under such conditions (including tolerance
limitations) as the Secretary may find necessary to assure the safe-
ty of the uses permitted; provides for the certification (or exemp-
tion from certification) of listed color additives for such permitted
uses; adapts the adulteration and other provisions of the act to the
substantive and other changes involoved in the above-mentioned
changes; and contains transitional provisions for commercially
established colors.
[p. 22]
II. SECTIONAL ANALYSIS
Title I—Amendments to Federal Food, Drug, and Cosmetic Act
*******
Section 102 (a)
Paragraph (1) adds color additives to the exceptions from section
402 (a) (2) (A) of the act, which now declares adulterated any food
bearing or containing a poisonous or deleterious added substance
which is unsafe within the meaning of section 406 of the act
"except a pesticide chemical in or on a raw agricultural commod-
ity and except a food additive." Under the bill, section 706 of the
act would (except during a transitional period) provide the exclu-
sive procedure for the listing (with or without tolerance limita-
tions) and certification of color additives.
Paragraph (2) amends section 402 (c) to deem a food adulter-
ated if "it is, or it bears or contains," a "color additive" which is
"unsafe within the meaning of section 706 (a)" of the basic act as
enacted by the bill. This would replace the present requirement of
section 402 (c) that deems adulterated a food bearing a coal-tar
color which is not from a batch certified under section 406 (b),
and the provisos to section 402 (c) with respect to the use of color
on oranges. (See Public Law 86-2.) (Sec. 406 (b) of the act would
be repealed under another section of the bill.) The effect of these
changes would be to (a) make the new provisions applicable to all
color additives, whether or not they are coal-tar colors; (b) extend
them to the color additive itself before being added to food; and
(c) use the technique of the pesticide chemicals amendment and
food additives amendment by deeming the article adulterated if the
additive is "unsafe" under another section (in this case the
amended sec. 706) of the basic act which sets forth the criteria
under which the additive shall be deemed unsafe.
Paragraph (3) adds to section 403 of the basic act a new subsec-
tion (1), whereby a food which is a color additive is deemed
misbranded unless packaged and labeled in accordance with pack-
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638 LEGAL COMPILATION—PESTICIDES
aging and labeling requirements, if any, contained in regulations
issued under section 706 (as amended by the bill). (Under the
basic act's definition of "food," a color additive intended to be
added to food is itself considered "food" before it is so added.)
[p. 23]
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 (c) 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]
^ * H« * * * *
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,
August 7, 1959.
Hon. OREN HARRIS,
Chairman, Committee on Interstate and Foreign Commerce,
House of Representatives, Washington, D.C.
DEAR MR. CHAIRMAN: We understand that representatives of some of the
industries that would be affected by H.R. 7624 (to be known as the Color Ad-
ditive Amendments of 1959) have suggested an amendment to the bill relating
to the requirements concerning analytical methods for color additives.
Under the bill in its present form (p. 9, lines 3-16), proposed section
706 (b) (4) of the Federal Food, Drug, and Cosmetic Act would preclude the
Secretary from listing a color additive for any use in or on food, drugs, or
cosmetics unless the data before him establish—
"(A) that such use, under the conditions of use to be specified in the
regulations, will be safe;
"(B) that practicable methods of analysis exist for determining the quan-
tity of the pure dye and all intermediates and other impurities contained in
such color additive; and
"(C) that practicable methods exist for determining the identity and
quantity (i) of such additive in or on any article of food, drug, or cosmetic,
and (ii) of any substance formed in or on such article because of the use
of such additive."
The proposed amendment suggested by industry representatives could con-
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STATUTES AND LEGISLATIVE HISTORY 639
solidate the matter contained in the above-quoted paragraphs (B) and (C)
and, with appropriate editorial revision, transfer it to section 706 (b) (5),
which begins on the same page and enumerates some of the most important
factors which the Secretary must consider in passing on the safety of a
proposed use of a color additive. As so amended, section 706(b) (4) and(5),
beginning on page 9, line 3, and ending on page 10, line 10, of the bill, would
read as follows:
"(4) The Secretary shall not list a color additive under this section for a
proposed use unless the data before him establish that such use, under the
conditions of use specified in the regulations, will be safe.
"(5) (A) in determining, for the purposes of this section, whether a pro-
posed use of a color additive is safe, the Secretary shall consider, among other
relevant factors—
"(i) the probable consumption of, or other relevant exposure from, the
additive and of any substance formed in or on food, drugs, or cosmetics
because of the use of the additive;
"(ii) the cumulative effect, if any, of such additive in the diet of man or
animals, taking into account the same or any chemically or pharmacologi-
cally related substance or substances in such diet;
"(iii) safety factors which, in the opinion of experts qualified by scientific
training and experience to evaluate the safety of color additives for the
use or uses for which the additive is proposed to be listed, are generally
recognized as appropriate for the use of animal experimentation data; and
"(iv) the availability of any needed practicable methods of analysis for
determining the identity and quantity of (I) the pure dye and all inter-
mediates and other impurities contained in such color additive, (II) such
additive in or on any article of food, drug, or cosmetic, and (III) any sub-
[p. 77]
stance formed in or on such article because of the use of such additive."
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 un-
less all of the described methods of analyses are available to him, without re-
gard to whether, with respect to a particular proposed listing of a color addi-
tive, 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 requirement that there be practicable
methods for determining the identity 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
present state of knowledge and that, in those cases in which there is no
need for such a method of analysis for adequate public health protection, the
requirement would unnecessarily bar the use of a color additive which would
be perfectly safe.
The purpose of the requirement of the bill that there be practicable meth-
ods of analysis for determining the quantity of the pure dye and all in-
termediates and other impurities contained in a color additive is to enable
the manufacturer of the color, and also this Department where we are asked
to certify batches of color, to determine that the color in actual practice
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640 LEGAL COMPILATION—PESTICIDES
meets the requirements for purity and the definitional standards of our regu-
lations, and to facilitate enforcement. The purpose of the other requirements
as to available practicable methods of analysis is to make possible effective
enforcement of any conditions or limitations that may be put on the listing of
a color for use in foods, drugs, or cosmetics. We, of course, regard practicabil-
ity and facility of enforcement as essential elements of safety in determining
whether a proposed use of a color additive is safe within the meaning of the
bill.
There are many circumstances where it would be necessary to have prac-
ticable analytical methods for all or most of the above-mentioned purposes.
We can, however, visualize some situations in which these analytical methods,
or some of them, would not be necessary for any of the purposes which we
have mentioned and would thus not be essential in the interest of sound pub-
lic health protection. We therefore recognize that in requiring such analytical
methods to be available in all cases without regard to actual need the original
bill goes further than absolutely necessary for public health protection.
Under the proposed change, we would consider ourselves bound to require
those analytical methods specified in the bill for which, on the basis of our
general knowledge or on the basis of the particular situation, we find that
there is a need for the above-mentioned purposes, or otherwise in the interest
of safeguarding the public health, and we would therefore feel bound to re-
fuse to list a color where such needed methods are not available. At the same
time, the proposed amendment would relieve us of the necessity of imposing
these requirements where they are not needed.
We therefore would not object to the proposed change in the bill.
The Bureau of the Budget advises that it perceives no objection to the sub-
mission of this report to your committee.
Sincerely yours,
ELLIOT L. RICHARDSON,
Assistant Secretary
[p. 78]
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
February 8,1960
HON. OREN HARRIS,
Chairman, Committee on Interstate and Foreign Commerce,
House of Representatives, Washington, D.C.
DEAR MR. CHAIRMAN : It has come to my attention that two questions have
been raised concerning the scope of the proposed color additives legislation
now being considered by your committee (S.2197 and H.R. 7624). Since these
questions were not covered by my testimony on January 26, I am taking this
opportunity of letting you have the views of our Department on them.
A representative of the packaging industry has expressed to us an appre-
hension that the Department's proposed legislation might be construed as
applying to coloring materials used in food wraps and other food packaging
materials even where the color does not migrate from the wrap to the food or,
if there is migration, where it is so slight that it would cause no color in
food discernible by the unaided eye.
It is our view that the color additives amendment would not apply to color
materials in food wraps that do not migrate from the wrap to the food.
Additionally, it is our view that the bill is intended to regulate substances
-------
STATUTES AND LEGISLATIVE HISTORY 641
that color or are capable of coloring food to a degree apparent to the naked
eye. Thus, a component of food packaging that migrated into food but did
not change its color in the ordinary sense of the term would continue to be
regulated, if necessary, under the food additives amendment and would not
become subject to the proposed color additives bill.
The second question relates to pesticide chemicals as defined in section
201 (q) of the Federal Food, Drug, and Cosmetic Act. We are advised that
certain fungicides used in fruit production have the effect not only of pro-
tecting the tree against plant diseases but also of effecting or supporting na-
tural plant processes so the plant produces better color and finish in the fruit;
and some plant growth regulators, when applied to plants, likewise enhance
the development of normal color in produce derived from them.
It is our view that pesticide chemicals used in this way are not color addi-
tives within the meaning of the proposed legislation and do not impart an
artificial color to the raw agricultural commodities. Rather, they promote the
development of the natural color of produce as a result of the normal physio-
logical processes of the plant. The legislation which we drafted was not in-
tended to apply to pesticide chemicals which enhance color by affecting or sup-
porting natural plant processes and we would expect to continue to regulate
pesticide chemicals, if the bill is enacted in its present form, under the pesti-
cide chemicals amendment and not the color additives amendment.
Sincerely yours,
ARTHUR S. FLEMMING, Secretary
[p. 79]
DEPARTMENT OP HEALTH, EDUCATION, AND WELFARE,
April 11, I960
HON. OREN HARRIS,
Chairman, Committee on Interstate and Foreign Commerce,
House of Representatives, Washington, D.C.
DEAR MR. CHAIRMAN : The purpose of this letter is to recommend a correc-
tion in the'hearing provision in title I of the proposed "Color Additive Amend-
ments of 1959" (H.R. 7624 and S. 2197) now pending before your committee.
As drafted by this Department and submitted to Congress, and as contained
in these bills, the hearing provision would, through an inadvertent cross-
reference to the subsection on fees, provide for hearing and judicial review not
only with respect to the issuance, amendment, or repeal of regulations relating
to the listing and certification of color additives, but also with respect to regu-
lations establishing fees for such listing and certification.
Under present law as consistently interpreted by us since its enactment,
the issuance or amendment of regulations establishing schedules of fees for
the listing and certification of coal-tar colors is not subject to hearing or ju-
dicial review (section 706 of Federal Food, Drug, and Cosmetic Act). This
likewise holds true in the case of fees for certification services for insulin or
antibiotics, fees for the pesticide regulation service, and fees for seafood in-
spection (sections 408 (o), 506, 507, 702A). The establishment of such fees is
purely a matter of cost accounting and, since the services must be self-sus-
taining, the fees are automatically kept at the appropriate level through
auditing of expenditures by the General Accounting Office. To provide for
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642 LEGAL COMPILATION—PESTICIDES
hearing and judicial review with respect to the establishment of fees would
thus serve no useful purpose and, on the other hand, might cause delay which
could seriously impede or make impossible the performance of the services
in question.
We therefore recommend that the provisions of these bills be corrected by
changing the phrase "subsections (b), (c), or (e) of this section" (H.R. 7624,
p. 13, line 6; S. 2197, p. 13, line 9) to read "subsection (b) or(c) of this
section."
Sincerely yours,
ARTHUR S. FLEMMING, Secretary
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,
Washington, D.C., April 21, 1960
HON. OREN HARRIS,
Chairman, Committee on Interstate and Foreign Commerce,
House of Representatives, Washington, D.C.
DEAR MR. CHAIRMAN : On January 29, you indicated during the hearings on
pending color additive legislation (H.R. 7624 and S. 2197) that you would like
to have our views on the various amendments proposed by witnesses other
than those representing this Department. Accordingly, we have reviewed the
record of the hearings and are glad to offer the following comments.
The amendments proposed by the witnesses fall into four principal cate-
gories :
1. There are a number of suggestions for change in the scope of the bills.
[p. 80]
2. There are several recommendations with respect to the substantive cri-
teria for listing colors, including a number of adverse comments on the
anticancer clause in the Department's proposal as contained in H.R. 7624.
The criticisms of the bill's anticancer clause also extend to the clause from
which it is derived, i.e., the so-called Delaney proviso in the Food Additives
Amendment of 1958.
3. A number of suggestions are made on procedural points, both with re-
spect to the permanent part (title I) and the transitional part (title II) of
the bill.
Additionally, one individual, Mr. Frank Schell, of Florida, has written to
the committee proposing an entirely new bill to be substituted for the De-
partment's bill.
Our comments on these various items, except the anticancer clause are en-
closed herewith (enclosure I). I expect to testify further on the anticancer
clause. There is enclosed herewith (enclosure II) a draft of a provision which
would accord an opportunity for hearing with respect to certain regulatory
actions under the transitional part of the bill, under the conditions stated in
my testimony. There is enclosed (enclosure III) a draft amendment to the
proposed section 706 (d) of the bills, to incorporate• time limits in the rule-
making procedure of the legislation if the committee should wish to do so.
Also there is enclosed (enclosure IV) a draft amendment to section 203 (d)
(2) (A) of the bill to make it clear that funds and regulations dealing with
the cost of certifying coal-tar colors under section 706 of the basic act, shall
continue to be available and in effect, respectively, for the purposes specified
in section 706 as amended by the proposed bill.
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STATUTES AND LEGISLATIVE HISTORY 643
In summary, we are opposed to all the amendments proposed by the wit-
nesses, except (1) a clarifying amendment on agricultural chemicals, in the
form contained in enclosure I agreed upon by us with the Department of Ag-
riculture, and (2) the amendments set forth in enclosures II and III. As
between the repective versions of S. 2197 and H.R. 7624, we have already
advised that the changes contained in S. 2197 as passed by the Senate are ac-
ceptable to us, except that we recommend inclusion of the anticancer clause
of H.R. 7624 with a modification relating to animal feed similar to the one
we are developing for the Delaney proviso to the Food Additive-s Amendment
of 1958. We have also recommended, by letter dated April 11, 1960, a technical
correction in section 706 (d).
Sincerely yours,
ARTHUR S. FLEMMING, Secretary
[Enclosure 1]
COMMENTS ON AMENDMENTS TO S. 2197 OR H.R. 7624,
PROPOSED BY NONGOVERNMENTAL WITNESSES
I. SCOPE OF BILL
1. Nature, source, or type of action of the coloring material
(a) * * *
(b) Agricultural chemicals.—Several witnesses suggested that
pesticide chemicals be exempted from the coverage of the color
additives legislation. A representative of the National Agricultural
Chemicals Association, on the other hand, indicated that the
[p. 81]
Department's position as to the interpretation of the bill—i.e., that
chemicals affecting color of fruit or other produce merely through
their effect on plant metabolism do not "impart color" within the
meaning of the bills—as submitted in our letter of February 8,
1960, to you, would meet the needs of the association. However, by
letter, the association has, we understand, requested that this
position be incorporated in the language of the bill rather than left
to legislative history. The Department of Agriculture also favors
this. We have no objection to incorporating the position in the bill
itself and suggest that the following language—jointly developed
by this Department and the Department of Agriculture, and sub-
mitted to the committee by that Department by letter dated April
14, 1960—be added as subparagraph (3) to the definition of the
term "color additive:"
"(3) Nothing in subparagraph (1) of this paragraph shall be
construed to apply to any pesticide chemical, soil or plant nutrient,
or other agricultural chemical solely because of its effect in aiding,
retarding, or otherwise affecting, directly or indirectly, the growth
or other natural physiological processes of produce of the soil and
thereby affecting its color, whether before or after harvest."
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644 LEGAL COMPILATION—PESTICIDES
More sweeping language suggested by the association and some
other witnesses, which would mandatorily exempt a pesticide
chemical even though that chemical also acts as a dye would be
seriously objectionable since it would result in our list of food
colors being incomplete and would admit of circumventing the
certification provisions of the bill through the development of
combined pesticide-dye chemicals. We invite attention to the fact
that the bill already excepts from the term "color additive" any
material "which the Secretary, by regulation, determines is used
(or intended to be used) solely for a purpose or purposes other
than coloring."
To avoid any misunderstanding, we emphasize that the Depart-
ment has no objection to the artificial coloring, under proper label-
ing declaration, of mature oranges. We have given this assurance
to the citrus industry, we have stated it for the record at the
hearings on the present bills, and we repeat it here.
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,
May IS, 1960.
Hon. OREN HARRIS,
Chairman, Committee on Interstate and Foreign Commerce,
House of Representatives, Washington, D.C.
DEAR MR. CHAIRMAN : On May 9, 1960, when I appeared before your com-
mittee with regard to proposed color additives legislation, you requested
that we comment on a proposal that has been made for amending the anti-
cancer clause of H.R. 7624. As we understand the proposal, it would change
section 706 (b) (5) (B) (i) so that it reads:
"(B) A color additive (i) shall be deemed unsafe and shall not be listed, for
any use which will or may result in ingestion of all or part of such additive,
if it is found, after tests which are appropriate for the evaluation of the safe-
[p. 82]
tly of additives for use in food, to induce cancer in man or animal, * * *."
(Interlined material present in original bill, but to be deleted.)
The deletion of the interlined language from the proposed color additives
bill, and deletion of comparable language from the anticancer clause of the
Food Additives Amendment of 1958, in view of the past history of the anti-
cancer clauses, is obviously designed to weaken the anticancer clause and to
allow room for the contention that our Department should establish toler-
ances to permit chemicals in food even though they had been found to induce
cancer when fed. This would serve no purpose except to lead to extended lit-
igation on this issue in the courts.
As you know from my testimony on January 26 and again on May 9,1960,
-------
STATUTES AND LEGISLATIVE HISTORY 645
we believe there is no sound scientific basis at this time for establishing tol-
erances to allow carcinogens to be added to food.
We recommend that the proposed change not be adopted.
Sincerely yours,
ARTHUR S. FLEMMING, Secretary
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,
Washington, May 13,1960.
Hon. OREN HARRIS,
Chairman, Committee on Interstate and Foreign Commerce,
House of Representatives, Washington, D.C.
DEAR MR. CHAIRMAN: As you know, in my testimony before your committee
on the color additive bills (H.R. 7624, S. 2197), I explained the need for modi-
fication of the Delaney (anticancer) proviso in the Food Additives Amendment
of 1958 insofar as animal feed is concerned, and the need for modification of
the so-called grandfather clause (sec. 201 (s) (3)) of the food additives amend-
ment, and stated that we were developing language to carry out these recom-
mendations. I also suggested that adoption of a parallel modification of the
anticancer clause of H.R. 7624 would be appropriate concomitantly with mod-
ification of the Delaney proviso.
At the close of my last appearance before the committee, you requested
that we submit the technical language which we had in mind to carry out
our recommendations, and you indicated that the record would be held open
to the end of this week.
We are therefore enclosing, for the consideration of the committee, proposed
amendments to the pending color bills which would carry out these recom-
mendations. The two amendments on food additives are in a measure com-
plementary to each other and, we believe, should be enacted at the same time.
In view of their urgency, and the close relation of one of these amendments
to the proposed modification of the anticancer clause of H.R. 7624, we hope
that they will be included in the pending legislation.
There is also enclosed herewith a further explanation of the need for, and
purposes of, the proposed changes in the Food Additives Amendment of 1958.
We should appreciate the inclusion of this letter and of the enclosures in the
record oi the hearings on H.R. 7624 and S. 2197.
[p. 83]
We are advised by the Bureau of the Budget that it perceives no objection
to the submission of these proposals.
Sincerely yours,
ARTHUR S. FLEMMING,
Secretary.
[p. 84]
EXPLANATION OF NEED FOR, AND PURPOSES OF, ENCLOSED DRAFT
AMENDMENTS TO GRANDFATHER CLAUSE AND ANTICANCER (DE-
LANEY) PROVISO OF FOOD ADDITIVES AMENDMENT OF 1958 (FOR
INCLUSION IN COLOR ADDITIVE BILL, WITH PARALLEL MODIFICA-
TION (ALSO ENCLOSED) OF ANTICANCER CLAUSE OF H.R. 7624)
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646 LEGAL COMPILATION—PESTICIDES
The enclosed draft amendments to the color additive legislation
would make two changes in those provisions of the Federal Food,
Drug, and Cosmetic Act which were added to that act by the Food
Additives Amendment of 1958 (Public Law 85-929), approved
September 6,1958.
Prior to the enactment of that amendment, pretesting and safety-
clearance requirements applied, in general, under the act only to
so-called pesticide chemicals used in or on raw agricultural commod-
[p.85]
ities (as provided by Public Law 518, 83d Cong.), except that drugs
used in animal feed or in other food, or administered directly to
animals raised for food production, were subject to safety clear-
ance under the new-drug provisions of the act (sec. 505). The
Food Additives Amendment of 1958 (Public Law 85-929) further
strengthened the public-health protection afforded by the act, by
prohibiting any food additive which has not been adequately tested
to establish affirmatively its safety for food use as determined
through a safety-clearance procedure established by that amend-
ment.
The underlying philosophy of the Food Additives Amendment of
1958 is that any reasonable doubt as to the safety of an additive
should be resolved against permitting its use. Moreover, in line
with this basic philosophy—and in the light of scientific evidence
before the House committee that present scientific knowledge is not
sufficient for determining a safe tolerance for the human diet in
the case of a substance which, when included in the diet of test
animals or otherwise administered to such animals through rele-
vant tests, induces cancer in such animals—the Congress inserted
in the law a proviso (known as the Delaney proviso) which bars a
substance completely for food use if it is "found to induce cancer
when ingested by man or animal, or if it is found, after tests which
are appropriate for the evaluation of the safety of food additives,
to induce cancer in man or animal."
The experience so far had under Public Law 85-929, however,
has disclosed a need for two modifications of the food additives
amendment which would better carry out its public-health objec-
tive and remove certain inequities.
1. Grandfather clause
In enacting the Food Additives Amendment of 1958, Congress
decided, in accordance with our recommendations, that in view of
its public-health objective it should in general apply not only to
new additives and new uses of existing additives, but also to uses
of additives already commercially established, subject to transi-
-------
STATUTES AND LEGISLATIVE HISTORY 647
tional provisions intended to allow a reasonable time for compli-
ance with the new pretesting requirements and safety-clearance
procedure. However, in order to avoid useless paperwork, the
amendment excluded from its scope two categories of additives
(in addition to pesticide chemicals for raw agricultural commodi-
ties) , i.e., any additive which is generally recognized by experts as
safe (such as salt, pepper, sugar, etc.) and also "any substance
used in accordance with a sanction or approval granted prior to the
enactment of [the Food Additives Amendment] pursuant to [the
Federal Food, Drug, and Cosmetic] Act, the Poultry Products
Inspection Act (21 U.S.C. 451 and the following) or the Meat
Inspection Act of March 4, 1907 (34 Stat. 1260), as amended and
extended (21 U.S.C. 71 and the following)."
Thus, while the last-quoted clause (which is now sec. 201 (s) (3),
but will be redesignated by the color additive bills as sec. 201 (s)
(4), of the Federal Food, Drug, and Cosmetic Act) is often for
convenience referred to as the "grandfather" clause of the Food
Additives Amendment, its purpose was not to confer any vested
right in a prior sanction or approval of an additive, but merely to
avoid the need for pro forma resort to the safety-clearance pro-
cedure of the amendment when the safety of the additive and of its
particular use has been satisfactorily established through a prior
sanction or approval. It was clearly understood that the so-called
[p. 86]
"grandfather" clause would be applicable only so long as the prior
sanction or approval remained in effect and that, as stated in the
explanation of this Department's draft bill from which the Food
Additives Amendment was derived, the clause "would not prevent
rescission of such a sanction or approval, and subsequent inclusion
of the additive under the bill, if the particular use of the additive
is subsequently found to be toxic or of doubtful safety." (Hearings
on food additives before a subcommittee of the House Committee
on Interstate and Foreign Commerce, 85th Cong. (1957 and 1958),
p. 28, at p. 35.) See also 21 C.F.R., sec. 121.3; 24 F.R. 2434, Mar.
28, 1959, which established certain notice requirements for with-
drawal or modification of such a prior sanction or approval.)
In submitting the grandfather clause to Congress, we had pri-
marily in mind official advice contained in letters of the Food and
Drug Administration (so-called trade correspondence) to mem-
bers of the food and chemical industries in response to inquiries
from them with respect to the interpretation or application of the
Federal Food, Drug, and Cosmetic Act. Such advice, not being
legally binding, could, of course, be withdrawn at any time without
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648 LEGAL COMPILATION—PESTICIDES
formal proceedings. However, there are also in effect certain prior
"sanctions" or "approvals" under the act—particularly those
granted for new drugs under section 505 of the act—which, though
granted in the first instance only on the basis of what was consid-
ered an affirmative showing of safety, cannot thereafter be with-
drawn unless the original application contained an untrue state-
ment of a material fact or unless the Government can establish—
on the basis of clinical experience, new test methods, or methods
not previously deemed reasonably applicable—that the article is
unsafe. This situation, of course, is contrary to the underlying
premise of the grandfather clause that the grandfather clause
would always become inapplicable when a previously sanctioned use
of a chemical additive to food was found to be of doubtful safety.
The law should make it very clear that establishing merely a
reasonable doubt as to the safety of any additive, in the light of all
available data, would be an adequate basis for withdrawal of any
sanction or approval with respect to it.
This creates a situation which is inconsistent with the above-
mentioned basic philosophy and public-health objective of the
Food Additives Amendment, and, in the case of a cancer-inducing
chemical, with the anticancer proviso of that amendment. In the
second place, it operates inequitably as between a person who holds
an effective new-drug application, antedating Public Law 85-929,
with respect to a drug manufactured by him for food use and who
is thus protected by the grandfather clause because it is not shown
to be unsafe but on which there may be doubt as to its safety, and
another person who desires to make and market the same drug for
the same purpose but who does not come within the grandfather
clause and cannot obtain clearance under the Food Additives
Amendment because the drug is banned by the anticancer proviso
or because for other reasons its safety cannot be affirmatively
demonstrated.
We therefore recommend amendment of the grandfather clause
so that, whenever on the basis of the information available to the
Secretary, he finds (after appropriate notice) that there is reason-
able doubt as to the safety of the use of an additive sanctioned or
approved pursuant to the Federal Food, Drug, and Cosmetic Act
[p. 87]
before enactment of Public Law 85-929, the grandfather clause
will, with respect to that sanction or approval, no longer apply, and
the safety-clearance requirements of the Food Additives Amend-
ment will apply, without regard to any other requirements of the
Food Additives Amendment will apply, without regard to any
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STATUTES AND LEGISLATIVE HISTORY 649
other requirements of the act relating to suspension or revocation
of such previous sanction or approval. If, in such a case, the addi-
tive is a carcinogen, this, of course, will mean that it is thereafter
subject to the above-quoted anticancer (Delaney) proviso, except
as proposed below with respect to animal feed.
2. Modification of Delaney proviso
[p. 88]
DEPARTMENT OF AGRICULTURE,
Washington, D.C., August 11,1959.
Hon. OREN HARRIS,
Chairman, Committee on Interstate and Foreign Commerce,
House of Representatives.
DEAR CONGRESSMAN HARRIS: This is in reply to your request of June 11, for
a report on H.R. 7624, a bill 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 regula-
tions prescribing the conditions (including maximum tolerances) under which
such additives may be safely used.
This Department would have no objection to enactment of the proposed
legislation. The proposed legislation would enable the Secretary of Health,
Education, and Welfare to take a realistic position with respect to the use of
colors in food products, many of which are agricultural products.
The bill would enable the Secretary of Health, Education, and Welfare to
establish tolerance limitations and other conditions of safe use for all color
additives in or on foods, drugs, and cosmetics, in a manner similar to that set
forth in the Food Additives Amendment of 1958. Under existing law the said
Secretary may not establish tolerance limitations for coal-tar colors. A color
additive would be deemed unsafe under the proposed bill if, among other
things, it is found after tests which are appropriate for the evaluation of such
additives to induce cancer in man or animals. The proposed legislation also
contains a provision that its terms should not be construed to exempt any
meat or meat food product or any person from any requirement imposed by or
pursuant to the Meat Inspection Act of the Poultry Products Inspection Act.
This provision is also considered to be consistent with and in no way modifying
the provisions of section 902 (b) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 392) which exempts meat and meat food products from the terms
of that act to the extent of the application thereto of the Meat Inspection Act.
Section 18 of the Poultry Products Inspection Act contains an exemption with
respect to poultry and poultry products similar to that contained in section
902 (b) of the Federal Food, Drug, and Cosmetic Act for meat and meat food
products.
We believe that all dyes and colorings for use in or on foods, drugs, and
cosmetics should be subject to the same principles presently applicable to food
additives. The Secretary of Health, Education, and Welfare should be permit-
ted to establish tolerances for these materials. Enactment of the proposed
legislation will avoid such special legislation as that enacted recently permit-
ting the addition of coloring to oranges (Public Law 86-2, approved March 17,
1959).
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650 LEGAL COMPILATION—PESTICIDES
The Bureau of the Budget advises that there is no objection to the
submission of this report.
Sincerely yours,
E. L. PETERSON, Acting Secretary.
[p. 90]
*******
DEPARTMENT OF AGRICULTURE,
Washington, D.C., May 16,1960,
Hon. OREN HARRIS,
Chairman, Committee on Interstate and Foreign Commerce,
House of Representatives.
DEAR CONGRESSMAN HARRIS: This is in further reference to the Depart-
ment's statement of March 11, before your committee on H.R. 7624 and S. 2197,
bills which would amend the Federal Food, Drug, and Cosmetic Act relating
to color additives. We indicated to the committee at that time that the Depart-
ment would prefer to delay making any recommendation with reference to the
so-called anticancer clause until there had been opportunity to consider the
matter further.
We now understand from consultations with representatives of the Depart-
ment of Health, Education, and Welfare that your committee may wish to
consider also the feasibility of amendments to the Food Additives Amendment
of 1958, which we understand are being sent to the committee by that Depart-
ment. Accordingly, we are also commenting on these amendments in this letter.
In the passage of the original Meat Inspection and Food and Drug Acts, the
Congress provided for the surveillance of all foods in interstate and foreign
commerce.
[P- 91]
In the case of meat, a comprehensive inspection system was established with
provisions for preclearance in the form of inspection of all carcasses, meats,
and meat food products, including approval or rejection of chemicals and other
additives. This is done under regulations issued by the Secretary of Agricul-
ture as circumstances and the advance of knowledge require, to assure that the
products marked "Inspected and Passed" are sound, healthful, wholesome, fit
for human food, and truthfully labeled.
In regard to other foods, covered under the original Food and Drug Act,
authority was not given for preclearance, but broad authority was estab-
lished for action against foods found in interstate or foreign commerce to be
in any way adulterated or misbranded.
In recent years, the trend in the Congress has been toward more preclear-
ance in order to serve two purposes: (1) To give greater assurance of safety
to the consumer; and (2) to give producers, processors, and distributors more
precise guidelines for their operations in order to assure the safety of foods
to consumers. Five congressional enactments are in point:
(a) The "new drugs" provisions of the Food, Drug, and Cosmetic Act of
1938 provided for the preclearance of drugs not generally recognized among
experts qualified by scientific training and experience as safe for use under
the conditions recommended.
(b) The Federal Insecticide, Fungicide, and Rodenticide Act of 1947
provided for USDA preexamination of economic poisons including labeling
to insure safety and effectiveness in use.
(c) The "Miller amendment" to the Food, Drug, and Cosmetic Act in 1954
-------
STATUTES AND LEGISLATIVE HISTORY 651
provided more workable procedures for HEW preclearance of pesticide
chemicals in or on raw agricultural commodities by authorizing the establish-
ment of tolerances when needed—legal levels—of such chemicals in these
products. The directions for use on labels registered by USDA for pesticides
are gaged to meet such tolerances in or on the raw agricultural commodities.
(d) The Poultry Products Inspection Act of 1957 provided for extension of
the meat inspection type of preclearance to poultry products by USDA.
(e) The Food Additives Amendment of 1958 to the Food, Drug, and Cos-
metic Act provided for preclearance of chemicals and other additives to foods.
In each case the Congress provided the mechanism which permits the exer-
cise of scientific and professional judgment in arriving at determinations of
safety of use and wholesomeness of the products. These are good provisions.
This Department fully supports them. The legislative histories show the
necessity for the exercise of such judgment to cope with the complexity of the
problems and the rapidly advancing state of knowledge concerning them.
[p. 92]
In addition, the Department of Health, Education, and Welfare is propos-
ing a modification of the prior sanction (grandfather) clause contained in
section 201 (s) of the Food, Drug, and Cosmetic Act as follows:
"The last numbered clause of section 201 (s) of the Federal Food, Drug,
and Cosmetic Act (which clause is redesignated as clause (4) by section
101 (a) of this act) is amended by inserting in such clause, before the period,
a colon and the following: 'Provided, That, with respect to any sanction or
approval granted pursuant to this Act, this clause shall be inapplicable, and
the provisions of this Act (other than this clause) relating to food additives
shall apply, to any such previously sanctioned or approved use of a substance
if, on the basis of the information then available, the Secretary finds that, for
the reasons set forth by him, there is reasonable doubt as to its safety. Except
when the Secretary finds that there is an imminent hazard to public health,
he shall take such action only in conformity with section 4 of the Adminis-
trative Procedure Act if such prior sanction or approval had been made
public, and only after sending reasonable notice of his proposed action and
the reasons therefor to any person on whose application such prior sanction
or approval had been granted and any other person who had been officially
advised thereof unless such personal notice is impracticable.' "
We have no objection to this proposal since it deals only with sanctions or
approvals granted by the Secretary of Health, Education, and Welfare under
the Food, Drug, and Cosmetic Act and would not affect the authority of this
Department or the impact of actions taken by it under programs which it
administers.
The Bureau of the Budget advises that there is no objection to the submis-
sion of this report.
Sincerely yours,
TRUE D. MORSE, Acting Secretary.
[p. 94]
1.2f (3) CONGRESSIONAL RECORD
1.2f (3) (a) VOL. 105 (1959), Aug. 24: Amended and passed
[No Relevant Discussion on Pertinent Section]
-------
652
LEGAL COMPILATION—PESTICIDES
COLOR ADDITIVE AMENDMENTS
OF 1960
Mr. DELANEY. Mr. Speaker, by di-
rection of the Committee on Rules I
call up House Resolution 559 and ask
for its immediate consideration.
1.2f (3) (b) VOL. 106 (1960), June 25: Debated, amended and
passed House, pp. 14349, 14355, 14357-14359, 14361-14362, 14378
for use. The Agency is now engaged in
retesting coal-tar dyes it cleared for
use many years ago, and as a result of
new and more sensitive testing pro-
cedures, a number of these dyes have
been found to be harmful and have
been removed from the approved list.
FDA figures that it would take 20
years *to complete the retesting pro-
gram. During that time the public
would have to run the risk of daily
exposure to dyes which have not been
clearly proven to be safe. This cannot
be justified on any grounds.
[p. 14350]
Mr. ALLEN.
The bill before us today is known as
a color additive bill and will regulate
the use of colors added to our daily
food supply, our drugs and cosmetics.
I anticipate that from time to time
there will be other bills to improve the
Federal Food, Drug, and Cosmetic Act.
H.R. 7624 originated with the De-
partment of Health, Education, and
Welfare, which sent copies of it last
year to both the Senate and the House.
The Senate committee took the bill,
deleted certain portions, and, without
holding a single hearing, reported it,
and it was passed without any floor
debate. I am absolutely opposed to the
Senate bill.
In the House, the Interstate and
Foreign Commerce Committee gave the
bill prolonged study and deliberation,
held many public hearings, listened on
three occasions to Secretary Flemming,
and then unanimously reported the bill.
While I do not consider this a perfect
bill, I think it is the best that we can
hope for at the present time, and I
support it.
[p. 14349]
The present bill also shifts the bur-
den of proof from the Government to
the sponsor of a color dye and it also
contains an anticancer provision.
It is vitally important for the pro-
tection of the consumer that the pro-
ducer of a dye be required to test it for
safety before permitting its introduc-
tion into our foods, drugs or cosmetics.
The Food and Drug Administration
simply does not have the facilities or
the staff to test all the colors proposed
If I may be so bold as to make some
suggestions, after following the learned
man on this subject, the gentleman
from New York. [Mr. DELANEY], I am
convinced that the Senate bill, as
passed, is a better bill. I am not saying
it on my own authority, but I am
saying it on the authority of many
chemists within and without the Gov-
ernment.
While I am in sympathy with the
purposes of this bill, I, after most
careful consideration, favor S. 2197 as
passed by the other body.
In my opinion the anticancer clause
in H.R. 7624, is unnecessary and re-
strictive.
I also believe that the decision on
safety be determined by the Secretary
of Health, Education, and Welfare
rather than be determined by law.
Otherwise, I am certain that our court
calendars presently loaded with pend-
ing cases in other fields will be even
more crowded. After all why should
not the Health, Education, and Welfare
Department, with firsthand scientific
information, decide as to safety.
It is my sincere hope that when in
-------
STATUTES AND LEGISLATIVE HISTORY
653
conference that these two defective
provisions be changed. Better still, the
bill presently before us should be
amended accordingly.
There are many chemists within and
without the Government whose judg-
ment is that the decision on safety
should be determined by the Secretary
of Health, Education, and Welfare
rather than be determined by law.
Mr. DELANEY. Under the provi-
sion of this bill, that is the case.
Mr. ALLEN. No, that is not my
understanding.
Mr. DELANEY. We are talking of
the color provisions now and, as I read
the bill here it is within his discretion.
Mr. ALLEN.That is not my under-
standing and I have a letter from some
very reliable people that I have very
recently received.
Mr. DELANEY. If the gentleman is
talking of the food additives provision,
the Secretary can determine that.
Mr. ALLEN. So I say, Mr. Speaker,
that with these two things, particularly
the latter part, if the Secretary of
Health, Education, and Welfare does
not make the decision and if it must
be decided according to the law, then
you are going to have more legislation
in the Federal courts than you have
now, and we all know that the courts
are pretty crowded now.
[p. 14351]
Mr. HARRIS. Mr. Speaker, I ask
unanimous consent that 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 accor-
dance with regulations prescribing the
conditions—including maximum toler-
ances—under which such additives may
be safely used, be considered in the
House as in Committee of the Whole.
The SPEAKER pro tempore. Is
there objection to the request of the
gentleman from Arkansas?
There was no objection.
The SPEAKER pro tempore. The
Clerk will report the bill.
[p. 14352]
Mr. HARRIS. Mr. Speaker, I ask
unanimous consent that the bill be
printed in the RECORD showing the
amendments.
The SPEAKER. Is there objection
to the request of the gentleman from
Arkansas?
There was no objection.
(The bill, as amended, reads as fol-
lows :)
Be it enacted by the Senate and House of
Representatives of the United States of Amer-
ica in Congress assembled. That this act may
be cited as the "Color Additive Amendments
of 1960."
TITLE I—AMENDMENTS TO THE FEDERAL POOD,
DRUG, AND COSMETIC ACT
Definitions
SEC. 101. Section 201, as amended, of the
Federal Food, Drug, and Cosmetic Act is
further amended as follows :
(a) Paragraph (s) of such section (defining
the term "food additive") is amended by re-
designating clause (3) as clause (4), and by
inserting immediately before clause (4), as so
redesignated, the following new clause:
"(3) a color additive; or".
(b) Paragraph (t) of such section is re-
designated and otherwise amended to read as
follows:
"(u) The term 'safe', as used in paragraph
(s) of this section and in sections 409 and
706, has reference to the health of man or
animal."
(c) There is inserted, immediately after
paragraph (s) of such section, the following
new paragraph:
"(t) (1) The term 'color additive' means a
material which—
"(A) is a dye, pigment, or other substance
made by a process of synthesis or similar
artifice, or extracted, isolated, or otherwise
derived, with or without intermediate or final
change of identity, from a vegetable, animal,
mineral, or other source, and
"(B) when added or applied to a food, drug,
or cosmetic, or to the human body or any part
thereof, is capable (alone or through reaction
with other substance) of imparting color
thereto;
except that such term does not include any
material which the Secretary, by regulation,
determines is used (or intended to be used)
solely for a purpose or purposes other than
coloring.
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654
LEGAL COMPILATION—PESTICIDES
"(2) The term 'color* includes black, white,
and intermediate grays.
"(3) Nothing in subparagraph (1) of this
paragraph shall be construed to apply to any
pesticide chemical, soil or plant nutrient, or
other agricultural chemical solely because of
its effect in aiding, retarding, or otherwise
affecting, directly or indirectly, the growth or
other natural physiological processes of pro-
duce of the soil and thereby affecting its color,
whether before or after harvest."
Colors or colored articles—when deemed to be
adulterated or miabranded foods, drugs, or
cosmetics
Food
SEC. 102. (a) (1) Clause (2) (A) of section
402(a), as amended, of such act (relating to
food deemed adulterated by reason of unsafe
additives) is further amended by striking out
the matter within the parentheses and inserting
in lieu thereof the following: "other than one
which is (i) a pesticide chemical in or on a raw
agricultural commodity; (ii) a food additive;
or (iii) a color additive."
(2) Section 402(c), as amended, of such act
(relating to food deemed adulterated by reason
of uncertified coal-tar color) is amended to
read as follows:
"(c) If it is, or it bears or contains, a color
additive which is unsafe within the meaning of
section 706(a)."
(3) Section 403 of such act (relating to the
circumstances under which food is deemed
misbranded) is amended by adding at the end
the* eof the following new paragraph:
" V m) If it is a color additive, unless its
packaging and labeling are in conformity with
such packaging and labeling requirements, ap-
plicable to such color additive, as may be con-
tained in regulations issued under section 706."
Drugs
(b)(l) Clause (4) of section 501(a) of such
act (relating to drugs deemed adulterated by
reason of uncertified coal-tar color) is amended
to read as follows: "(4) if (A) it is a drug
which bears or contains, for purposes of coloring
only, a color additive which is unsafe within
the meaning of section 706(a), or (B) it is a
color additive the intended use of which in or
on drugs is for purposes of coloring only and is
unsafe within the meaning of section 706(a)."
(2) Section 502 of such Act (relating to the
circumstances under which drugs are deemed
misbranded) is amended by adding at the end
thereof the following new paragraph:
"(m) If it is a color additive the intended use
of which in or on drugs is for the purpose of
coloring only, unless its packaging and labeling
are in conformity with such packaging and
labeling requirements, applicable to such color
additive, as may be contained in regulations
issued under section 706."
Cosmetics
(c)(l) Section 601(e) of such Act (relating
to cosmetics, other than hair dyes, deemed
adulterated by reason of uncertified coal-tar
color) is amended to read as follows:
"(e) If it is not a hair dye and it is, or it
bears or contains, a color additive which is
unsafe within the meaning of section 706(a)."
(2) Section 602 of such Act (relating to the
circumstances under which cosmetics shall be
deemed to be misbranded) is amended by adding
at the end thereof the following new paragraph:
"(e) If it is a color additive, unless its pack-
aging and labeling are in conformity with such
packaging and labeling requirements, applicable
to such color additive, as may be contained in
regulations issued under section 706. This para-
graph shall not apply to packages of color
additives which, with respect to their use for
cosmetics, are marketed and intended for use
only in or on hair dyes (as defined in the last
sentenceof section 601 (a) )."
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 ;
[p.14353]
(3) repealing section 604 ; and
(4) amending section 701(e) by (A) striking
out "406 (a) or (b)" and inserting in lieu
thereof "406" ; (B) striking out "504, or 604" ;
and (C) inserting the word "or" after "501
(b),".
(b) Section 706 of such Act is amended to
read as follows:
"Listing and certification of color additives for
foods, drugs, and cosmetics
"When Color Additives Deemed Unsafe
"SfiC, 706. (a) A color additive shall, with
respect to any particular use (for which it is
being used or intended to be used or is repre-
sented as suitable) in or on food or drugs or
cosmetics, be deemed unsafe for the purposes of
the application of section 402(c), section 501(a)
(4), or section 601 (e), as the case may be,
unless—
"(1)(A) there is in effect, and such additive
and such use are in conformity with, a regula-
tion issued under subsection (b) of this section
listing such additive for such use, including any
provision of such regulation prescribing the
conditions under which such additive may be
safely used, and (B) such additive either (i) is
from a batch certified, in accordance with
regulations issued pursuant to subsection (c),
for such use, or (ii) has, with respect to such
use, been exempted by the Secretary from the
requirement of certification ; or
-------
STATUTES AND LEGISLATIVE HISTORY
655
"(2) such additive and such use thereof
conform to the terms of an exemption which is
in effect pursuant to subsection (f) of this
section.
While there are in effect regulations under
subsections (b) and (c) of this section relating
to a color additive or an exemption pursuant to
subsection (f) with respect to such additive, an
article shall not, by reason of bearing or con-
taining such additive in all respects in accor-
dance with such regulations or such exemption,
be considered adulterated within the meaning
of clause (1) of section 402{a) if such article is
a food, or within the meaning of section 601 (a)
if such article is a cosmetic other than a hair
dye (as denned in the last sentence of section
601(a) ).
"Listing of Colors
"(b)(l) The Secretary shall, by regulation,
provide for separately listing color additives for
use in or on food, color additives for use in or on
drugs, and color additives for use in or on cos-
metics, if and to the extent that such additives
are suitable and safe for any such use when
employed in accordance with such regulations.
"(2) (A) Such regulations may list any color
additive for use generally in or on food, or in or
on dru^s, or in or on cosmetics, if tbe Secretary
finds that such additive is suitable and may
safely be employed for such genera] use.
"(B) If the data before the Secretary do not
establish that the additive satisfies the require-
ments for listing such additive on the applicable
list pursuant to subparagraph (A) of this para-
graph, or if the proposal is for listing such
additive for a more limited use or uses, such
regulations may list such additive only for any
more limited use or uses for which it is suitable
and may safely be employed.
"(3) Such regulations shall, to the extent
deemed necessary by the Secretary to assure
the safety of the use or uses for which a par-
ticular additive is listed, prescribe the condi-
tions under which such additive may be safely
employed for such use or uses (including, but
not limited to, specifications, hereafter in this
section referred to as tolerance limitations, as
to the maximum quantity or quantities which
may be used or permitted to remain in or on
the article or articles in or on which it is used;
specifications as to the manner in which such
additive may be added to or used in or on such
article or articles ; and directions or other label-
ing or packaging requirements for such addi-
tive) .
"(4) The Secretary shall not list a color
additive under this section for a proposed use
unless the data before him establish that such
use, under the conditions of use specified in the
regulations, will be safe: Provided, however,
That a color additive shall be deemed to be
suitable and safe for the purpose of listing
under this subsection for use generally in or
on food, while there is in effect a published
finding of the Secretary declaring such sub-
stance exempt from the term 'food additive*
because of its being generally recognized by
qualified experts as safe for its intended use,
as provided in section 201 (s).
"(5) (A) In determining for the purposes of
this section, whether a proposed use of a color
additive is safe, the Secretary shall consider,
among other relevant factors—
"(i) the probable consumption of, or other
relevant exposure from, the additive and of
any substance formed in or on food, drugs, or
cosmetics because of the use of the additive,
"(ii) the cumulative effect, if any, of such
additive in the diet of man or animals, taking
into account the same or any chemically or
pharmacologically related substance or sub-
stances in such diet;
"(in) safety factors which, in the opinion
of experts qualified by scientific training and
experience to evaluate the safety of color addi-
tives for the use or uses for which the additive
is proposed to be listed, are generally recog-
nized as appropriate for the use of animal
experimentation data; and
"(iv) the availability of any needed prac-
ticable methods of analysis for determining the
identity and quantity of (I) the pure dye and
all intermediates and other impurities contained
in such color additive, (II) such additive in or
on any article of food, drug, or cosmetic, and
(III) any substance formed in or on such ar-
ticle because of the use of such additive.
"(B) A color additive (i) shall be deemed
unsafe, and shall not be listed, for any use
which will or may result in ingestion of all
or part of such additive, if the additive is
found by the Secretary to induce cancer when
ingested by man or animal, or if it is found
by the Secretary, after tests which are ap-
propriate for the evaluation of the safety
of additives for use in food, to induce cancer
in man or animal, and (ii) shall be deemed
unsafe, and shall not be listed, for any use
which will not result in ingestion of any part
of such additive, if, after tests which are ap-
propriate for the evaluation of the safety of
additives for such use, or after other relevant
exposure of man or animal to such additive, it
is found by the Secretary to induce cancer in
man or animal.
"(C){i) In any proceeding for the issuance,
amendment, or repeal of a regulation listing a
color additive, whether commenced by a pro-
posal of the Secretary on his own initiative
or by a proposal contained in a petition, the
petitioner, or any other person who will be
adversely affected by such proposal or by the
Secretary's order issued in accordance with
paragraph (1) or section 701 (e)) if placed in
effect, may request, within the time specified
in this subparagraph, that the petition or order
thereon, or the Secretary's proposal, be referred
-------
656
LEGAL COMPILATION—PESTICIDES
to an advisory committee for a report and
recommendations with respect to any matter
arising under subparagraph (B) of this para-
graph, which is involved in such proposal or
order and which requires the exercise of scien-
tific judgment. Upon such request, or if the
Secretary within such time deems such a re-
ferral necessary, the Secretary shall forthwith
appoint an advisory committee under subpara-
graph (D) of this paragraph and shall refer
to it, together with all the data before him,
such matter arising under subparagraph (B)
for study thereof and for a report and recom-
mendations on such matter. A person who has
filed a petition or who has requested the re-
ferral of a matter to an advisory committee
pursuant to this subparagraph (C), as well as
representatives of the Department of Health,
Education, and Welfare, shall have the right
to consult with such advisory committee in
connection with the matter referred to it. The
request for referral under this subparagraph,
or the Secretary's referral on his own initia-
tive, may be made at any time before, or within
thirty days after, publication of an order of the
Secretary acting upon the petition or proposal.
"(ii) Within sixty days after the date of
such referral, or within an additional thirty
days if the committee deems such additional
time necessary, the committee shall, after in-
dependent study of the data furnished to it
by the Secretary and other data before it, cer-
tify to the Secretary a report and recommenda-
tions, together with all underlying data and
a statement of the reasons or basis for the
recommendations. A copy of the foregoing
shall be promptly supplied by the Secretary to
any person who has filed a petition, or who
has requested such referral to the advisory
committee. Within thirty days after such certi-
fication, and after giving due consideration
to all data then before him, including such re-
port, recommendations, underlying data, and
statement, and to any prior order issued by
him in connection with such matter, the Secre-
tary shall by order confirm or modify any order
theretofore issued or, if no such prior order
has been issued, shall by order act upon the
petition or other proposal.
(iii) Where—
"(I) by reason of subparagraph (B) of this
paragraph, the Secretary has initiated a pro-
posal to remove from listing a color additive
previously listed pursuant to this section ; and
(II) a request has been made for referral
of such proposal to an advisory committee;
the Secretary may not act by order on such
proposal until the advisory committee has made
a report and recommendations to him under
clause (ii) of this subparagraph and he has con-
sidered such recommendations, unless the Sec-
retary finds that emergency conditions exist
necessitating the issuance of an order not-
withstanding this clause.
"(D) The advisory committee referred to in
subparagraph (C) of this paragraph shall be
composed of experts selected by the National
Academy of Sciences, qualified in the subject
matter referred to the committee and of ade-
quately diversified professional background, ex-
cept that in the event of the inability or re-
fusal of the National Academy of Sciences to
act, the Secretary shall select the members of
the committee. The size of the committee shall
be determined by the Secretary. Members of
an advisory committee shall receive as compen-
sation for their services a reasonable per diem,
which the Secretary shall by rules and regula-
tions prescribe, for time actually spent in the
work of the committee, and shall in addition be
reimbursed for their necessary traveling and
subsistence expenses while so serving away from
their places of residence. The members shall
not be subject to any other provisions of law
regarding the appointment and compensation
of employees of the United States. The Sec-
retary shall furnish the committee with ade-
quate clerical and other assistance, and shall
by rules and regulations prescribe the proce-
dure to be followed by the committee.
"(6) The Secretary shall not list a color
additive under this subsection for a proposed
use if the data before him show that such pro-
posed use would promote deception of the con-
sumer in violation of this Act or would other-
wise result in misbranding or adulteration with-
in the meaning of this Act.
[p. 14354]
"(7) If, in the judgment of the Secretary,
a tolerance limitation is required in order to
assure that a proposed use of a color additive
will be safe, the Secretary—
"(A) shall not list the additive for such use
if he finds that the data before him do not
establish that such additive, if used within a
safe tolerance limitation, would achieve the in-
tended physical or other technical effect; and
"(B) shall net fix such tolerance limitation
at a level higher than he finds to be reasonably
required to accomplish the intended physical
or other technical effect.
"(8) If, having regard to the aggregate quan-
tity of color additive likely to be consumed in
the diet or to be applied to the human body,
the Secretary finds that the data before him fail
to show that it would be safe and otherwise
permissible to list a color additive (or pharma-
cologically related color additives) for all the
uses proposed therefor and at the levels of
concentration proposed, the Secretary shall, in
determining for which use or uses such addi-
tive (or such related additives) shall be or re-
main listed, or how the aggregate allowable
safe tolerance for such additive or additives
shall be allocated by him among the uses under
consideration, take into account, among other
relevant factors (and subject to the paramount
criterion of safety), (A) the relative market-
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STATUTES AND LEGISLATIVE HISTORY
657
ability of the articles involved as affected by
the proposed uses of the color additive (or of
such related additives) in or on such articles,
and the relative dependence of the industries
concerned on such uses; (B) the relative ag-
gregate amounts of such color additive which
he estimates would be consumed in the diet or
applied to the human body by reason of the
various uses and levels of concentration pro-
posed ; and (C) the availability, if any, of other
color additives suitable and safe for one or
more of the uses proposed.
"Certification of Colors
"(c) The Secretary shall further, by regula-
tion, provide (1) for the certification, with safe
diluents or without diluents, of batches of
color additives listed pursuant to subsection (b)
and conforming to the requirements for such
additives established by regulations under such
subsection and this subsection, and (2) for
exemption from the requirement of certifica-
tion in the case of any such additive, or any
listing or use thereof, for which he finds such
requirement not to be necessary in the interest
of the protection of the public health: Provided,
That with respect to any use in or on food for
which a listed color additive is deemed to be
safe by reason of the proviso to paragraph (4)
of subsection (b), the requirement of certifica-
tion shall be deemed not to be necessary in
the interest of public health protection.
"Procedure for Issuance, Amendment, or
Repeal of Regulations
"(d) The provisions of section 701 (e), (f),
and (g) of this Act shall, subject to the pro-
visions of subparagraph (C) of subsection
(b) (5) of this section, apply to and in all
respects govern proceedings for the issuance,
amendment, or repeal of regulations under
subsection (b) or (c) of this section (including
judicial review of the Secretary's action in such
proceedings) and the admissibility of tran-
scripts of the record of such proceedings in
other proceedings, except that—-
"(1) if the proceeding is commenced by the
filing of a petition, notice of the proposal
made by the petition shall be published in
general terms by the Secretary within thirty
days after such filing, and the Secretary's
order {required by paragraph (1) of section
701 (e) acting upon such proposal shall, in the
absence of prior referral (or request for re-
ferral) to an advisory committee, be issued
within ninety days after the date of such filing,
except that the Secretary may (prior to such
ninetieth day), by written notice to the peti-
tioner, extend such ninety-day period to such
time (not more than one hundred and eighty
days after the date of filing of the petition)
as the Secretary deems necessary to enable him
to study and investigate the petition ;
"(2) any report, recommendations, under-
lying data, and reasons certified to the Secre-
tary by an advisory committee appointed
pursuant to subparagraph (D) of subsection
(b)(5) of this section, shall be made a part
of the record of any hearing if relevant and
material, subject to the provisions of section
7(c) of the Administrative Procedure Act (B
U S.C., sec. 1006 (c)). The advisory committee
shall designate a member to appear and testify
at any such hearing with respect to the report
and recommendations of such committee upon
request of the Secretary, the petitioner, or the
officer conducting the hearing, but this shall not
preclude any other member of the advisory
committee from appearing and testifying at
such hearing ;
"(3) the Secretary's order after public hear-
ing (acting upon objections filed to an order
made prior to hearing) shall be subject to the
requirements of section 409 {f)(2) ; and
"(4) the scope of judicial review of such
order shall be in accordance with the fourth
sentence of paragraph (2), and with the pro-
visions of paragraph (3), of section 409(g).
"Fees
"(e) The admitting to listing and certification
of color additives, in accordance with regula-
tions prescribed under this Act, shall be per-
formed 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 (is-
sued 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 qual-
ified experts when in his opinion such exemp-
tion is consistent with the public health."
Confidentiality of trade secrets
SEC. 104. Section 301(j), as amended, of such
Act, prohibiting disclosure of trade secrets, is
amended by striking out "or 704" and inserting
in lieu thereof "704, or 706".
Changes in cross-reference and terminology
SEC. 105. Such Act is further amended by—
(a) striking out, in section 301 (i) thereof
relating to forgery or unauthorized use of cer-
tain 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) (relating to color manufacturer's guar-
antee), the word "coal-tar" wherever it ap-
pears in such clause, and (2) inserting after
the word "color", wherever it appears in such
clause, the word "additive" ; and
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658
LEGAL COMPILATION—PESTICIDES
(c) striking out "harmless coloring" in sec-
tion 402 (d) (relating to nonnutritive substances
in confectionery) and inserting in lieu thereof
"authorized coloring".
TITLE II—EFFECTIVE DATE, TRANSITIONAL
PROVISIONS, AND EFFECT ON OTHER LAWS
Definitions
SEC. 201. As used in this title, the term "basic
Act" means the Federal Food, Drug, and Cos-
metic Act; the term "enactment date" means
the date of enactment of this Act; and other
terms, insofar as also used in the basic Act
(whether before or after enactment of this Act)
shall have the same meaning as they have, or
had when in effect, under the basic Act.
Effective date
SEC. 202. This Act shall, subject to the pro-
visions of section 203, take effect on the enact-
ment date.
Provisional listings of commercially
established colors
SEC. 203. (a)(l) The purpose of this section
is to make possible, on an interim basis for a
reasonable period, through provisional listings,
the use of commercially established color addi-
tives to the extent consistent with the public
health, pending the completion of the scientific
investigations needed as a basis for making de-
terminations as to listing of such additives
under the basic Act as amended by this Act.
A provisional listing (including a deemed pro-
visional listing) of a color additive under this
section for any use shall, unless sooner ter-
minated or expiring under the provisions of this
section, expire (A) on the closing date (as
defined in paragraph (2) of this subsection)
or (B) on the effective date of a listing of such
additive for such use under section 706 of the
basic Act, whichever date first occurs.
(2) For the purposes of this section, the
term "closing date" means (A) the last day
of the two and one-half year period beginning
on the enactment date or (B), with respect to
a particular provisional listing (or deemed
provisional listing) of a color additive or use
thereof, such later closing date as the Secretary
may from time to time establish pursuant to
the authority of this paragraph. The Secretary
may by regulation, upon application of an
interested person or on his own initiative, from
time to time postpone the original closing date
with respect to a provisional listing (or deemed
provisional listing) under this section of a
specified color additive, or of a specified use or
uses of such additive, for such period or periods
as he finds necessary to carry out the purpose
of this section, if in the Secretary's judgment
such action is consistent with the objective of
carrying to completion in good faith, as soon as
reasonably practicable, the scientific investiga-
tions necessary for making a determination as
to listing such additive, or such specified use or
uses thereof, under section 706 of the basic Act.
The Secretary may terminate a postponement
of the closing date at any time if he finds that
such postponement should not have been grant-
ed, or that by reason of a change in circum-
stances the basis for such postponement no
longer exists, or that there has been a failure
to comply with a requirement for submission of
progress reports or with other conditions at-
tached to such postponement.
(b) Subject to the other provisions of this
section—
(1) any color additive which, on the day pre-
ceding the enactment date, was listed and
certifiable for any use or uses under section
406(b), 504, or 604, or under the third proviso
of section 402(c), of the basic Act, and of which
a batch or batches had been certified for such
use or uses prior to the enactment date, and
(2) any color additive which was commer-
cially used or sold prior to the enactment date
for any use or uses in or on any food, drug, or
cosmetic, and which either, (A), on the day pre-
ceding the enactment date, was not a material
within the purview of any of the provisions of
the basic Act enumerated in paragraph (1) of
this subsection, or (B) is the color additive
known as synthetic beta-carotene,
shall, beginning on the enactment date, be
deemed to be provisionally listed under this
section as a color additive for such use or uses.
Mr. HARRIS.
[p. 14355]
GENERAL SUMMARY
In brief, the committee bill, first,
takes color additives out of the scope of
the food additives amendment of 1958;
second, repeals the present provisions
of the Federal Food, Drug, and Cos-
metic Act for the listing and certifi-
cation of "harmless" coal-tar colors
(sees. 406(b), 504, and 604); third,
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 limitations—as the
Secretary of Health, Education, and
Welfare may find necessary to assure
the safety of the uses permitted;
fourth, provides for the certification
(or exemption from certification) of
listed color additives for such per-
mitted uses; fifth, adapts the adul-
teration and other provisions of the
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STATUTES AND LEGISLATIVE HISTORY
659
Federal Food, Drug, and Cosmetic
Act to the substantive and other
changes involved in the above-men-
tioned changes; and sixth, contains
transitional provisions for commer-
cially established colors.
*****
So-called coal-tar colors are regu-
lated under the act through similar
sets of provisions in chapters IV
Food, V Drugs, and VI Cosmetics. The
act requires the Secretary of Health,
Education, and Welfare to provide by
regulation for listing and certifying
batches of "coal-tar colors which are
harmless and suitable for use" in
food, drugs, and cosmetics.
Food containing coal-tar color is
deemed adulterated under section 402
(c) of the act unless the color is from
a batch certified by the Secretary un-
der section 406. Section 406 (b) then
directs the Secretary to provide for
listing coal-tar colors that are harm-
less and suitable for use in food to
provide for certifying batches of such
colors.
The Secretary of Health, Educa-
tion, and Welfare is without authority
to admit a coal-tar color to listing
under tolerance limitations; it must
be harmless per se in order for the
Secretary to admit it to listing—
Flemming v. Florida Citrus Exchange
(358 U.S. 153 (1958)).
Under section 409 the food additive
is deemed unsafe unless it and its use,
or intended use, conform to a regula-
tion issued by the Secretary announc-
ing the conditions, including the es-
tablishment of tolerance limitations,
under which the additive may be
safely used. Food colors which were
in commercial use before January 1,
1958, are allowed a grace period not
later than March 6, 1961, for compli-
ance with the provisions of the Food
Additives Amendment of 1958. Such
"food additive" colors, however, are
not subject to any requirement of
"batch" certification.
NEED FOR LEGISLATION
The principal reasons which give
rise to the need for this legislation
may be summarized as follows:
First. The law with respect to coal-
tar colors—and this comprises most
synthetic colors—is not in consonance
with modern concepts of consumer
protection, in that it does not allow
the Secretary of Health, Education,
and Welfare to list a color for safe
use under regulations which place a
limit on the amount of a color that
may be used on an article and to es-
tablish other conditions of use. For
food, and for drugs and cosmetics
other than those externally applied,
the Secretary must ban the use of
such a color completely, as not being
harmless, if it is found to be toxic in
the laboratory when fed to animals
in some concentrations, even though
its actual level and manner of use
may be completely safe. For external-
ly applied drugs and cosmetics, the
same principle applies if toxicity ap-
pears in the laboratory in some con-
centrations by any relevant type of
test, even though its actual level and
manner of use may be wholly safe.
Prior to delisting proceedings fay
the Department of Health, Education,
and Welfare there were 19 colors
listed for unrestricted use in food,
drugs, and cosmetics, 69 colors listed
for unrestricted use in drugs and cos-
metics, and 30 colors listed for use
only in externally applied drugs and
cosmetics, a total of 118 straight col-
ors listed for certification. Seven col-
ors have been removed from the food,
drug, and cosmetic list and have been
relisted for external use in drugs and
cosmetic colors, so that we now have
12 food, drug, and cosmetic colors, 69
unrestricted drug and cosmetic colors,
and 37 drug and cosmetic colors for
external use. The Department has
-------
660
LEGAL COMPILATION—PESTICIDES
proposed that other colors be removed
from listing and certification.
Only last week the Food and Drug
Administration announced a tentative
decision removing 14 coal-tar colors
used principally in lipsticks from the
list of permitted colors for unre-
stricted use in drugs and cosmetics.
This decision was based upon an
evaluation of evidence presented at a
public hearing granted color, lipstick,
and drug manufacturers. A final de-
cision on delisting will be made after
consideration of any objections which
may be filed by the affected parties to
the proposed order.
The principle of allowing colors to
be used under tolerance limitations
was endorsed, in 1956, by a commit-
tee of recognized scientists appointed
by the National Academy of Sciences
to review the coal-tar color research
program of the Food and Drug Ad-
ministration, as indicated by the fol-
lowing excerpt from the committee's
report:
This committee feels compelled to indicate
that certification of a compound as harmless
and suitable for use in food, drugs, and cos-
metics as required under present law is un-
realistic unless the level of use is specified
(report of the National Academy of Sciences-
National Research Council Ad Hoc Advisory
Committee To Review the Food and Drug Ad-
ministration's Research Program on Coal-tar
Dyes, June 1956).
Second. The theoretically perfect
public health protection once thought
to be accorded by the present law re-
garding coal-tar colors has turned out
to be in fact inadequate. While theo-
retically, only harmless colors may be
listed, a retesting program of the
Food and Drug Administration, em-
ploying the most modern testing tech-
niques, has led to the discovery that
many of the so-called coal-tar colors
on the list may in fact be toxic in
some concentrations. Yet, the Secre-
tary of Health, Education, and Wel-
fare cannot take a particular color
off the list until he establishes its tox-
icity by laboratory tests, a process
which for the list as a whole may
take as much as 20 years. Under the
bill, there would, in general, be a
maximum of 2% years during which
the retesting process for the estab-
lished colors would have to be com-
pleted—primarily by industry—and
during which the Secretary could es-
tablish temporary tolerance limita-
tions, at zero level if necessary, to pro-
tect the public health. This maximum
period could be extended only where,
in a particular case, such extension is
necessary to complete the required
safety tests for a color and is found
consistent with protection of the pub-
lic health.
Third. 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 pre-
testing requirements and, where nec-
essary for the protection of color
users and consumers, the same re-
quirement for certification of colors
to assure their purity and identity
with those listed as safe. At present
there are no provisions for the cer-
tification of non-coal-tar colors. There
is, moreover, no pretesting require-
ment for non-coal-tar additives as
such, other than food additives.
Fourth. Unless the law, as pro-
posed by the bill, is brought into con-
formity with modern methods of con-
trol by incorporation of the safe-for-
use principle, it will become increas-
ingly difficult, and may eventually be-
come impossible, to find permissible
colors to supply the demand for vari-
ous important color uses on the part
of consumers as well as the food,
drug, and cosmetic industries. From
the standpoint of the public interest
there is no compensating advantage
for the inflexibility of the present
law in this respect.
The food, drug, cosmetic, and color
industries find themselves in a serious
situation as the result of the removal
of color after color from the lists un-
[p. 14357]
-------
STATUTES AND LEGISLATIVE HISTORY
661
der the present inflexible provisions of
the law. Unless the law, by permitting
the testing of colors under safe toler-
ances, is brought into line with pres-
ent-day methods of control, the emer-
gency will grow and deepen, an emer-
gency which the Secretary of Health,
Education, and Welfare believes could
be relieved for most established colors
on a sound and permanent basis by
enacting the provisions of this bill
without in any way conflicting with
the need for adequate protection of
the public health.
There is no justification, from the
point of view of the public interest, in
driving either color manufacturers or
food, drug, or cosmetic producers, de-
pendent upon the use of color, out of
business where the particular use of
color involved is one which can safely
be admitted under proper conditions
of use—including tolerance limita- t
tions and certification requirements
—established by the Department of
Health, Education, and Welfare.
The scientifically sound principle
that we must consider conditions of
use when passing on suitability and
safety of a color additive has recently
been approved by Congress in tempo-
rary emergency legislation — Public
Law 86-2—with respect to one coal-
tar color, i.e., citrus red No. 2 for use
in coloring mature oranges, after pre-
vious adoption of the "Safe-for-use"
principle in the Food Additives
Amendment of 1958—Public Law 85-
929. In reporting upon the emergency
legislation for citrus red No. 2, this
committee said:
It is specifically provided that the provisions
of this bill will become inoperative on August
31, 1961, or before that time if general legisla-
tion affecting coloring materials for food is
enacted by the Congress. The reason for the
time limit is that this emergency legislation,
which will meet the immediate needs of the
citrus industry without permanently engrafting
on the basic Pood, Drug, and Cosmetic Act a
new principle of tolerances for coal-tar colors
which is not applicable to foods generally. The
expiration date has been so fixed as to allow
the Congress ample time to consider the appli-
cation of this principle to all foods.
It is the intention of the committee as soon
as feasible to study amendments to the Federal
Food, Drug, and Cosmetic Act dealing with
color additives generally, since the need for
such legislation has been amply demonstrated to
this committee (86th Cong., 1st sess., H.
Kept. 88).
The bill—by permitting, for a rea-
sonable period, the provisional listing
and certification of heretofore com-
mercially established colors, under
temporary tolerances where necessary
for public-health protection, pending
the development of the scientific data
required for a definitive determina-
tion as to the listing of these colors
under the permanent provisions of
the bill—would permit an orderly
transition to the control procedures
of the bill. At the same time, the bill
would establish on a permanent basis
a sound system of color regulation
fully protective of consumer interests.
EXPLANATION OF COMMITTEE BILL
The bill would change existing law
in the following major respects:
First. Uniform criteria of admissi-
bility. It would do away with the dif-
ferences in legal requirements and
treatment as between the so-called
coal-tar colors and other color addi-
tives, and would establish an inte-
grated 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 accomplished
by excepting color additives—as de-
nned in the bill—from the term "food
additive"; repealing the present pro-
visions for listing and certification of
coal-tar colors; enacting, as part of
a single section—section 706—compre-
hensive provisions for the separate
listing of any color additives suitable
and safe for general or restricted use
in foods, drugs, or cosmetics, and for
their certification—or exemption from
certification—and making other amend-
ments to the act to mesh with these
provisions.
The bill would embrace all color ad-
ditives whether or not synthesized
-------
662
LEGAL COMPILATION—PESTICIDES
and whether or not capable of deriva-
tion from a coal-tar constituent. From
the point of view of determining safe-
ty 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 be-
tween so-called coal-tar colors and
other coloring substances will have
the incidental effect of establishing a
pretesting and safety clearance re-
quirement 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
was forcefully brought to the atten-
tion of Congress by the investigations
and recommendations of the House
Select Committee To Investigate the
Use of Chemicals in Foods and Cos-
metics, the Delaney committee in the
82d Congress, and by the hearings
culminating in the enactment of the
Food Additives Amendment of 1958.
Second. Safety-of-use principle. The
bill adopts for all colors, and for all
color uses covered by it, the basic
principle of the Food Additives
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 deter-
mined to be safe, subject to such con-
ditions of use (including maximum
tolerance limitations) as are deter-
mined to be necessary to assure the
safety of such use.
Third. The Delaney anticancer
clause. One provision of the bill which
aroused considerable controversy in
the hearings on this legislation is
proposed section 706(b)(5)(B) ap-
pearing on page 11, line 8, of the re-
ported bill, and often referred to as
the Delaney anticancer clause.
This clause provides that a color
additive shall be deemed unsafe and
shall not be listed for any use which
will or may result in ingestion of all
or any part of such additive if the ad-
ditive is found to induce cancer when
ingested by man or animal, or if it is
found to induce cancer in man or
animal by other tests, not involving
ingestion, which are considered to be
appropriate for the evaluation of the
safety of additives for use in food.
[p. 14358]
In view of the uncertainty sur-
rounding the determination of safe
tolerances for carcinogens, the com-
mittee decided that the Delaney anti-
cancer provision in the reported bill
should be retained without change.
Fourth. Comprehensive lists. The
bill retains the approach of the pres-
ent coal-tar color provisions in pro-
viding for comprehensive lists of col-
ors, instead of attempting to carve
out an exception from listing for col-
ors "generally recognized" by experts
as safe for use. While there may have
been justification in the case of the
Food Additives Amendments of 1958
for placing the burden on the Gov-
ernment to prove that an additive is
not generally recognized as safe be-
fore 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—the
Secretary of Health, Education, and
Welfare does not believe that such an
exception is sound in the case of color
additives, whether they be extracted
from a natural source or synthesized.
If a color is in fact generally recog-
nized 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. It may be noted, however,
that a committee amendment to the
bill deems a color additive to be suit-
-------
STATUTES AND LEGISLATIVE HISTORY
663
able and safe for the purpose of list-
ing for use generally in food, where
there is in effect a published finding
of the Department that the substance
is generally recognized as safe for its
intended use within the meaning of
the provisions exempting such sub-
stances from the Food Additives
Amendments of 1958.
Fifth. Certification and exemptions
from certification. While providing
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
certification is not necessary to pro-
tect 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 regula-
tions 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 require-
ment is desirable, especially since the
coverage of the law is broadened to
include all types of substances capa-
ble of imparting color.
Sixth. Effective date and transi-
tional 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.
[p. 14359]
However, in order to allow on an
interim basis, for a reasonable period,
the use of commercially established
color additives to the extent consis-
tent with the public health, pending
completion of the scientific investiga-
tions needed as a basis for making
determinations as to listing of such
additives under the new permanent
provisions 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 es-
tablished" color additives falling un-
der these transitional provisions are
first, those coal-tar colors of which a
batch or batches were actually certi-
fied prior to the date of enactment of
the bill; and second, those non-coal-tar
colors, and synthetic beta-carotene,
which were commercially used or sold
prior to that date for food, drug, or
cosmetic use.
Provisional listings would be sub-
ject to appropriate temporary tolerance
limitations and other conditions of use
when deemed necessary for the pro-
tection 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 pro-
tection of the public health so re-
quires.
A provisional listing would be auto-
matic 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 transitional pro-
visions only upon request to the Sec-
retary of Health, Education, and Wel-
fare.
Seventh. Deception. A witness be-
fore the committee suggested amend-
ing proposed section 706 (b) (6) to add
the word "harmful" before the word
"deception" so as to provide that the
Secretary shall not list a color addi-
tive for a proposed use if the data
before him show that such proposed
use would "promote harmful decep-
tion of the consumer in violation of
this Act or would otherwise result in
misbranding or adulteration within
the meaning of this Act."
The Federal Food, Drug, and Cos-
metic Act prohibits, among other
things, the introduction of an adulter-
ated or misbranded food, drug, or cos-
metic into interstate commerce, or the
-------
664
LEGAL COMPILATION—PESTICIDES
adulteration or misbranding of any
food, drug, device, or cosmetic in inter-
state commerce, or while held for sale
after interstate shipment. Further-
more, the food additives amendment—
section 409 (c) (3) (B) of the act—
specifically prohibits the Secretary
from issuing a regulation prescribing
the conditions under which a food addi-
tive may be safely used if a fair evalu-
ation of the data before him shows
that the proposed use of the additive
would "promote deception of the con-
sumer in violation of this Act or would
otherwise result in adulteration or in
misbranding of food within the mean-
ing of this Act."
The committee is of the opinion that
it would be unsound policy to legislate
against deception of the consumer in
the food additives law and against
harmful deception of the consumer in
the color additives law. Obviously, the
provision against deception of the con-
sumer should be identical under both
sections of the law. It should be em-
phasized that we are dealing here
solely with deception which would vio-
late the law.
[p. 14361]
Mr. SULLIVAN.
*****
For instance, the Secretary of
Health, Education, and Welfare made
a strong request to the committee for
an amendment on this bill to cover a
serious loophole in the Food Additives
Act of 1958. The Secretary explained
how that loophole got into the act—be-
cause the Department apparently made
a too-sweeping statement in some of
the language which it drafted for the
Food Additives Act several years ago.
As a result, any food additive which
was ever cleared by any Government
agency as being safe for the use in-
tended, now has what amounts to an
unjustified "grandfather's clause" pro-
tecting it from removal action un-
less the Government has proof of its
danger. This is an intolerable interpre-
tation of what Congress intended. The
committee, however, has failed to rec-
ommend the repeal or modification of
this language in the 1958 act, even
though this provision has been causing
great difficulty and, in the case of the
stilbestrol-treated chickens, could be
handled only through voluntary agree-
ment at a cost of many millions of dol-
lars to the Federal Treasury and the
taxpayers.
The committee states in its report on
H.R. 7624 that it is not recommending
amendment of the Food Additives Act
of 1958 in the color legislation because
it did not consider such amendments
directly germane to the color bill. It
said it would consider such amend-
ments at a later date—presumably in
the next Congress. I think this is a
much more serious problem, however,
than the coal-tar color problem.
*****
I cannot support a bill which weak-
ens our consumer protections for the
economic benefit of manufacturers us-
ing coloring material which is not
completely safe. I particularly cannot
support such weakening of our con-
sumer laws, when we are not taking
any steps at the same time to close
glaring loopholes in the Food, Drug,
and Cosmetics Act.
[p. 14369]
The bill was ordered to be read a
third time, was read the third time, and
passed.
A motion to reconsider was laid on
the table.
The proceedings whereby H.R. 7624
was passed were vacated and that bill
was laid on the table.
[p. 14378]
1.2f (3) (c) VOL. 106 (1960), June 30: Senate concurs in House
amendments, pp. 15133-15137
[No Relevant Discussion on Pertinent Section]
-------
STATUTES AND LEGISLATIVE HISTORY 665
1.2g ADMINISTRATIVE AGENCY PROCEEDINGS ACT,
AUGUST 28,1958, P.L. 85-791, §20, 72 STAT. 947
SEC. 20. (a) The first and second sentences of paragraph (2) of
subsection (i) of section 408 of the Federal Food, Drug, and
Cosmetic Act, as added by the Act of July 22, 1954 (ch. 559, 68
Stat. 515), are amended to read as follows:
[p. 947]
"(2) In the case of a petition with respect to an order under
subsection (d) (5) or (e), 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 provided in section 2112 of title 28,
United States Code. Upon the filing of such petition, the court shall
have exclusive jurisdiction to affirm or set aside the order com-
plained of in whole or in part."
(b) The first and second sentences of paragraph (3) of sub-
section (i) of section 408 of the Federal Food, Drug, and Cosmetic
Act, as added by the Act of July 22, 1954 (ch. 559, 68 Stat. 515),
are amended to read as follows:
"(3) In the case of a petition with respect to an order under
subsection (1), a copy of the petition shall be forthwith trans-
mitted by the clerk of the court to the Secretary of Agriculture, 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 provided in section 2112 of title 28,
United States Code. Upon the filing of such petition, the court
shall have exclusive jurisdiction to affirm or set aside the order
complained of in whole or in part."
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-
-------
666 LEGAL COMPILATION—PESTICIDES
tion, the court shall have jurisdiction to affirm the order, or to set
it aside in whole or in part, temporarily or permanently."
SEC. 22. The second and third sentences of subsection (a) of
section 10 of the Fair Labor Standards Act of 1938 (52 Stat. 1065),
as amended, are amended to read as follows: "A copy of such
petition shall forthwith be transmitted by the clerk of the court to
the Secretary, and thereupon the Secretary shall file in the court
the record of the industry committee upon which the order com-
plained of was entered, as provided in section 2112 of title 28,
United States Code. Upon the filing of such petition such court
shall have exclusive jurisdiction to affirm, modify, or set aside
such order in whole or in part, so far as it is applicable to the
petitioner." [p g4g]
1.2g (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. WILLIS, 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
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 favor-
ably thereon with amendments and recommend that the bill do pass.
The amendments are as follows:
*!
*******
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.
-------
STATUTES AND LEGISLATIVE HISTORY 667
In many instances much of the record made before such
agencies is not relevant to the questions actually raised on appeal.
This legislation, in permitting an abbreviated record to be trans-
mitted, 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]
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 fol-
lows: '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 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]
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668 LEGAL COMPILATION—PESTICIDES
1.2g (2) SENATE COMMITTEE ON THE JUDICIARY
S. REP. No. 2129, 85th Cong., 2nd 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 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.I]
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
-------
STATUTES AND LEGISLATIVE HISTORY 669
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 adminis-
trative 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
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 residuum of doubt as to whether specific
provisions would have been repealed by implication. This legisla-
tion avoids that difficulty by direct amendment of the many
existing statutes providing for judicial review of administrative
determinations and orders.
[P-2]
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
bureaus 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
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670 LEGAL COMPILATION—PESTICIDES
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 individual 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.
[P-4]
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
[transcript] 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 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 [The] court shall have
jurisdiction to affirm the order, or to set 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 671
1.2g (3) CONGRESSIONAL RECORD
1.2g (3) (a) Vol. 103 (1957), Aug. 5: Amended and passed House,
pp. 13617-13621
[No Relevant Discussion on Pertinent Section]
1.2g (3) (b) Vol. 104 (1958), Aug. 14: Passed Senate, p. 17537
[No Relevant Discussion on Pertinent Section]
1.2h AMENDMENTS TO FOOD ADDITIVES JUNE 29, 1960,
P.L. 86-546, 74 STAT. 255
AN ACT
To make the uniform law relating to the record on review of agency orders
(Public Law 85-791) applicable to the judicial review of orders issued under
the Federal Aviation Act of 1958 and the Food Additives Amendment of 1958.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, That subsection
(c) of section 1006 of the Federal Aviation Act of 1958 (72 Stat.
795) is amended to read as follows:
" (c) A copy of the petition shall, upon filing, be forthwith trans-
mitted to the Board or Administrator by the clerk of the court,
and the Board or Administrator shall thereupon file in the court
the record, if any, upon which the order complained of was entered,
as provided in section 2112 of title 28, United States Code."
SEC. 2. The first and second sentences of paragraph (2) of
subsection (g) of section 409 of the Federal Food, Drug, and
Cosmetic Act, as added by the Food Additives Amendment of
1958 (72 Stat. 1788), are amended to read as follows: "A copy of
such 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 provided
in section 2112 of title 28, United States Code. Upon the filing of
such petition the court shall have jurisdiction, which upon the
filing of the record with it shall be exclusive, to affirm or set aside
the order complained of in whole or in part. Until the filing of the
record the Secretary may modify or set aside his order."
Approved June 29,1960.
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672 LEGAL COMPILATION—PESTICIDES
1.2h (1) HOUSE COMMITTEE ON THE JUDICIARY
H.R. REP. No. 1462, 86th Cong., 2d Sess. (1960)
REVIEW OF CERTAIN AGENCY ORDERS
APRIL 7,1960.—Referred to the House Calendar and ordered to be printed
Mr. WILLIS, from the Committee on the Judiciary, submitted the
following
REPORT
[To accompany H.R. 7847]
The Committee on the Judiciary, to whom was referred the bill
(H.R. 7847) to make the uniform law relating to the record on
review of agency orders (Public Law 85-791) applicable to the
judicial review of orders issued under the Federal Aviation Act
of 1958 and the Food Additives Amendment of 1958, having
considered the same, report favorably thereon with amendment
and recommend that the bill do pass.
The amendment is as follows:
On page 2, line 12, strike out the last sentence and insert in lieu
thereof the following:
Upon the filing of such petition the court shall have juris-
diction, which upon the filing of the record with it shall be
exclusive, to affirm or set aside the order complained of
in whole or in part. Until the filing of the record the Secretary
may modify or set aside his order.
EXPLANATION OF AMENDMENT
To bring the pertinent part of section 2 of the bill into line with
the provisions of present law (21 U.S.C. 348 (g) (2)) which give
the court exclusive jurisdiction upon the filing of the transcript of
the record and not, as set forth in the bill as introduced, upon the
filing of the petition.
PURPOSE
The purpose of this legislation is to bring judicial review provi-
sions of the Federal Aviation Act of 1958 and the Food Additives
Amendment of 1958 under the uniform provisions of Public Law
85-791 relating to court review of Government agency orders.
[P.I]
ANALYSIS OF THE BILL
*******
Section 2 of the bill provides that appeals under section 409 of
-------
STATUTES AND LEGISLATIVE HISTORY 673
the Federal Food, Drug-, and Cosmetic Act, as amended, taken
from agency orders shall be accomplished by filing a petition with
the court. The clerk of the court shall forthwith transmit to the
Secretary of Health, Education, and Welfare, or his designee, a
copy of the petition, and upon receipt thereof the Secretary shall
file in the court the record of the proceedings upon which the
order complained of is based, in accordance with provisions of
section 2112 title 28, United States Code. Upon the filing of such
petition the court has jurisdiction which, upon the filing of the
record, becomes exclusive to affirm or set aside the order com-
plained of. Until the filing of the record, however, the Secretary
may modify or set aside his order.
The committee wishes to make clear that the provision of the
last sentence of the amended bill, which gives the court exclusive
jurisdiction upon the filing of the record, is not intended to modify
the application of the provisions of 28 U.S.C. 2112 that determines
which single court of appeals has jurisdiction where proceedings
to review the same agency order are instituted in two or more
courts of appeals.
[p. 6]
CHANGES IN EXISTING LAW
In compliance with clause 3 of rule XIII of the House of Repre-
sentatives, there is printed below in roman existing law in which
no change is proposed, with matter proposed to be stricken out
enclosed in black brackets, and new matter proposed to be added
shown in italic:
72 Stat. 795; 49 U.S.C. 1486
JUDICIAL REVIEW OF ORDERS
ORDERS OF BOARD AND ADMINISTRATOR SUBJECT TO REVIEW
SEC. 1006. (a) * * *
(b) * * *
(c) Notice to Board or Administrator; filing of transcript.
[A copy of the petition shall, upon filing be forthwith transmit-
ted to the Board or Administrator by the clerk of the Court, and
the Board or Administrator shall thereupon certify and file in the
court a transcript of the record, if any, upon which the order
complained of was entered.]
A copy of the petition shall, upon filing, be forthwith transmitted
to the Board or Administrator by the clerk of the court, and the
Board or Administrator shall thereupon file in the court the record,
if any, upon which the order complained of was entered, as pro-
vided in section 2112 of title 28, United States Code.
-------
674 LEGAL COMPILATION—PESTICIDES
72 Stat. 1788; 21 U.S.C. 348g(2)
SEC. 409.
(g) Judicial review.
(1) * * *
(2) [A copy of such petition shall be forthwith served upon the
Secretary, or upon any officer designated by him for that purpose,
and thereupon the Secretary shall certify and file in the court a
transcript of the proceedings and the record on which he based
his order. Upon such filing, the court shall have exclusive juris-
diction to affirm or set aside the order complained of in whole or
in part.]
A copy of such 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 provided in section 2112 of title 28, United States Code. Upon
the filing of such petition the court shall have jurisdiction, which
upon the filing of the record with it shall be exclusive, to affirm
or set aside the order complained of in whole or in part. Until the
filing of the record the Secretary may modify or set aside his
order. * * *
[p. 8]
1.2h (2) SENATE COMMITTEE ON THE JUDICIARY
S. REP. No. 1566, 86th Cong., 2d Sess. (1960)
[No Relevant Discussion]
1.2h (3) CONGRESSIONAL RECORD, VOL. 106 (1960)
1.2h (3) (a) April 19: Amended and passed House, p. 8190
[No Relevant Discussion on Pertinent Section]
1.2h (3) (b) June 18: Passed Senate, p. 13203
[No Relevant Discussion on Pertinent Section]
1.2i DRUG AMENDMENTS OF 1962, OCTOBER 10, 1962,
P.L. 87-781, TITLE I, SECTION 104(f) (1), 76 Stat. 785
SEC. 104.
*******
(f) (1) Clause (A) of paragraph (3) of section 409 (c) of
such Act (21 U.S.C. 348 (c)) is amended by inserting before the
semicolon at the end thereof the following: ", except that this
proviso shall not apply with respect to the use of a substance as
an ingredient of feed for animals which are raised for food pro-
duction, if the Secretary finds (i) that, under the conditions of
-------
STATUTES AND LEGISLATIVE HISTORY 675
use and feeding specified in proposed labeling and reasonably
certain to be followed in practice, such additive will not adversely
affect the animals for which such feed is intended, and (ii) that
no residue of the additive will be found (by methods of examina-
tion prescribed or approved by the Secretary by regulations, which
regulations shall not be subject to subsections (f) and (g)) in any
edible portion of such animal after slaughter or in any food
yielded by or derived from the living animal".
(2) Subparagraph (B) of paragraph (5) of section 706 (b) of
such Act (21 U.S.C. 376 (b)) is amended by inserting before the
period at the end of the subparagraph a colon and the following
proviso: "Provided, That clause (i) of this subparagraph (B)
shall not apply with respect to the use of a color additive as an
ingredient of feed for animals which are raised for food produc-
tion, if the Secretary finds that, under the conditions of use and
feeding specified in proposed labeling and reasonably certain
to be followed in practice, such additive will not adversely affect
the animals for which such feed is intended, and that no residue
of the additive will be found (by methods of examination pre-
scribed or approved by the Secretary by regulations, which regu-
lations shall not be subject to subsection (d) in any edible portion
of such animals after slaughter or in any food yielded by or derived
from the living animal".
[p. 785]
1.2i (1) SENATE COMMITTEE ON THE JUDICIARY
S. REP. No. 1744 (part 1 & 2), 87th Cong., 2d. Sess. (1962)
DRUG INDUSTRY ACT OF 1962
JULY 19,1962.—Ordered to be printed
Mr. EASTLAND, from the Committee on the Judiciary, submitted
the following
REPORT
together with
INDIVIDUAL VIEWS
[To accompany S. 1552]
The Committee on the Judiciary, to which was referred the bill
(S. 1552) to amend and supplement the antitrust laws with re-
spect to the manufacture and distribution of drugs, and for other
purposes, having considered the same, reports favorably thereon,
-------
676 LEGAL COMPILATION—PESTICIDES
with an amendment in the nature of a substitute, and recommends
that the bill, as amended, do pass.
AMENDMENT
Strike all after the enacting clause and insert in lieu thereof the
following':
That this Act may be cited as the "Drug Industry Act of 1962".
[No Relevant Discussion on Pertinent Section]
[p.l]
1.2i (2) HOUSE COMMITTEE ON INTERSTATE AND FOR-
EIGN COMMERCE
H.R. REP. No. 2464, 87th Cong., 2d Sess. (1962)
DRUG AMENDMENTS OF 1962
SEPTEMBER 22, 1962.—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. 11581]
The Committee on Interstate and Foreign Commerce, to whom
was referred the bill (H.R. 11581) to protect the public health
by amending the Federal Food, Drug, and Cosmetic Act to assure
the safety, efficacy, and reliability of drugs, authorize standard-
ization of drug names, establish special controls for barbiturate
and stimulant drugs, and clarify and strengthen existing inspec-
tion authority with respect to any articles subject to the act; and
to amend related laws, having considered the same, report favor-
ably thereon with amendments and recommend that the bill as
amended do pass.
The amendments are as follows:
The amendment to the text strikes out all of the bill after the
enacting clause and inserts in lieu thereof a substitute which
appears in the reported bill in italic type. The substitute text is
also printed in appendix C.
The other amendment modifies the title of the bill to make it
conform to the changes made by the amendment to the text.
[p.l]
-------
STATUTES AND LEGISLATIVE HISTORY 677
ANIMAL FEED
The committee amended the anticancer clause of the food addi-
tives amendment and the color additive amendment of the Federal
Food, Drug, and Cosmetic Act by making this clause inapplicable
to chemicals such as veterinary drugs when used in feed for food-
producing animals if the Secretary finds (1) that under the con-
ditions of use and feeding specified in the proposed labeling and
reasonably certain to be followed in practice, such additive will
not adversely affect the animals for which such feed is intended,
and (2) that no residue of the additive will be found (by methods
of examination prescribed or approved by the Secretary by regu-
lations) in any edible portion of the animal after slaughter or in
any food such as milk or eggs yielded by or derived from the
living animal. , --,
[p. 5]
COMMITTEE HEARINGS
The committee held extensive hearings on June 19-22, 1962, on
H.R. 11581 and H.R. 11582 and on August 20-23, 1962, on H.R.
11581. Both of these bills were introduced by Chairman Harris at
the request of the Department of Health, Education, and Welfare
to give effect to a part of the President's message on consumer
protection.
H.R. 11581 seeks to amend the Federal Food, Drug, and Cos-
metic Act to assure the safety, efficacy, and reliability of drugs;
authorize standardization of drug "names; establish special con-
trols for barbiturate and stimulant drugs; and clarify and strength-
en existing inspection authority with respect to any articles subject
to the act.
H.R. 11582 seeks to amend this act to require a premarketing
showing of the safety of cosmetics; assure the safety, efficacy, and
reliability of therapeutic, diagnostic, and prosthetic devices; and
amend the act with respect to cautionary labeling.
[p-6]
Lack of time prevented further committee consideration of the
bill, H.R. 11582, and it is expected that this legislation will be
considered further during the next Congress.
While the committee had under consideration H.R. 11581, there
was referred to the committee a Senate passed pill, S. 1552. The
Senate bill deals in a somewhat different manner with several of
the aspects covered by H.R. 11581.
The committee in executive session considered the provisions
both of H.R. 11581 and S. 1552. The committee amendment in the
nature of a substitute takes the place of both of these bills.
The committee amendment omits provisions relating to the con-
-------
678 LEGAL COMPILATION—PESTICIDES
trol of barbiturates and stimulant drugs and biological drugs
which were contained in H.R. 11581. The committee expects to
give careful consideration to these provisions during the next
Congress.
AGENCY REPORTS
Agency reports relating to H.R. 11581 are shown in appendix A
to this report.
SECTION-BY-SECTION ANALYSIS OF BILL
SHORT TITLE
The first section of the bill would provide that the act may be
cited as the "Drug Amendments of 1962."
[p. 7]
Section 104(f) amends sections 409 (c) and 706 (d) of the
Federal Food, Drug, and Cosmetic Act, by making the anticancer
clause of the Food Additives Amendment of 1958 and the Color
Additive Amendment of 1960 inapplicable to chemicals, such as
veterinary drugs, when used in feed for food-producing animals if
the Secretary finds (1) that under the conditions of use and feeding
specified in the proposed labeling and reasonably certain to be
followed in practice, such additive will not adversely affect the
animals for which such feed is intended, and (2) that no residue
of the additive will be found (by methods of examination pre-
scribed or approved by the Secretary by regulations) in any edible
portion of the animal after slaughter or in any food, such as milk
or eggs, yielded by or derived from the living animal.
[p. 11]
1.2i (3) COMMITTEE OF CONFERENCE
H.R. REP. No. 2526, 87th Cong., 2d Sess. (1962)
DRUG AMENDMENTS OF 1962
OCTOBER 3,1962.—Ordered to be printed
Mr. ROBERTS of Alabama, from the committee of conference, sub-
mitted the following
CONFERENCE REPORT
[To accompany S. 1552]
The committee of conference on the disagreeing votes of the two
Houses on the amendments of the House to the bill (S. 1552) to
amend and supplement the laws with respect to the manufacture
and distribution of drugs, and for other purposes, having met,
-------
STATUTES AND LEGISLATIVE HISTORY 679
after full and free conference, have agreed to recommend and
do recommend to their respective Houses as follows:
That the Senate recede from its disagreement to the amend-
ment of the House 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 House
amendment insert the following:
That this Act, divided into titles and sections according to the
following table of contents, may be cited as the "Drug Amend-
ments of 1962".
TABLE OF CONTENTS
TITLE I—DRUGS
PART A—AMENDMENTS TO ASSURE SAFETY, EFFECTIVENESS, AND RELIABILITY
Sec. 101. Requirement of adequate controls in manufacture.
Sec. 102. Effectiveness and safety of new drugs.
Sec. 103. Records and reports as to experience on new drugs.
Sec. 104. New drug clearance procedure.
Sec. 105. Certification of antibiotics
Sec. 106. Records and reports as to experience on antibiotics.
Sec. 107. Effective dates and application of part A.
PART B—STANDARDIZATION OF DRUG NAMES
Sec. 111. Review and designation of official names.
Sec. 112. Name to be used on drug label.
Sec. 113. Exclusion of cosmetics.
Sec. 114. Information to physicians.
[p.l]
PART C—AMENDMENTS AS TO ADVERTISING
Sec. 1S1. Prescription drug advertisements.
TITLE II—FACTORY INSPECTION AND EFFECT ON STATE LAWS
Sec. 201. Factory inspection.
Sec. 80S. Effective on State laws
Sec. 203. Effective date.
TITLE III—REGISTRATION OF DRUG ESTABLISHMENTS AND PATENT INFORMATION
Sec. 301. Findings and declaration.
Sec. SOU. Registration of producers of drugs.
Sec. 303. Transitional provisions.
Sec. 304. Failure to register.
Sec. SOS. Drugs from nonregistered establishments misbranded.
Sec. SOS. Samples of imported drugs.
Sec. 307. Definitions.
Sec. 308. Information on patents for drugs.
[p. 2]
-------
680 LEGAL COMPILATION—PESTICIDES
NEW DRUG CLEARANCE PROCEDURE
Sec. 104. (a) Section 505 (a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355 (a)), is amended to read as follows:
[p. 5]
(f)(l) Clause (A) of paragraph (3) of section 409(c) of such
Act (21 U.S.C. 348 (c)) is amended by inserting before the semi-
colon at the end thereof the following: ", except that this proviso
shall not apply with respect to the use of a substance as an in-
gredient of feed for animals which are raised for food production,
if the Secretary finds (i) that, under the conditions of use and feed-
ing specified in proposed labeling and reasonably certain to be fol-
lowed in practice, such additive will not adversely affect the ani-
[p.6]
mals for which such feed is intended, and (ii) that no residue of
the additive will be found (by methods of examination prescribed
or approved by the Secretary by regulations, which regulations
shall not be subject to subsections (f) and (g)) in any edible por-
tion of such animal after slaughter or in any food yielded by or
derived from the living animal".
(2) Subparagraph (B) of paragraph (5) of section 706 (b) of
such Act (21 U.S.C. 376(b)) is amended by inserting before the
period at the end of the subparagraph a colon and the following
proviso: "Provided, That clause (i) of this subparagraph (B) shall
not apply with respect to the use of a color additive as an ingredi-
ent of feed for animals which are raised for food production, if
the Secretary finds that, under the conditions of use and feeding
specified in proposed labeling and reasonably certain to be followed
in practice, such additive will not adversely affect the animals
for which such feed is intended, and that no residue of the addi-
tive will be found (by methods of examination prescribed or
approved by the Secretary by regulations, which regulations shall
not be subject to subsection (d)) in any edible portion of such
animals after slaughter or in any food yielded by or derived from
the living animal".
[p. 7]
And the House agree to the same.
-------
STATUTES AND LEGISLATIVE HISTORY 681
That the Senate recede from its disagreement to the amendment
of the House to the title and agree to the same.
OREN HARRIS,
KENNETH A. ROBERTS,
LEO W. O'BRIEN,
PAUL G. ROGERS,
JOHN B. BENNETT,
PAUL F. SCHENCK,
ANCHER NELSEN,
Managers on the Part of the House.
JAMES 0. EASTLAND,
ESTES KEFAUVER,
OLIN D. JOHNSTON,
EVERETT M. DIRKSEN,
ROMAN L. HRUSKA,
Managers on the Part of the Senate.
[p. 18]
STATEMENT OF THE MANAGERS ON THE PART OF THE
HOUSE
The managers on the part of the House at the conference on
the disagreeing votes of the two Houses on the amendments of
the House to the bill (S. 1552) to amend and supplement the laws
with respect to the manufacture and distribution of drugs, and
for other purposes, submit the following statement in explanation
of the effect of the action agreed upon by the conferees and recom-
mended in the accompanying conference report:
The House struck out all of the Senate bill after the enacting
clause and inserted a substitute amendment.
The committee of conference has agreed to a substitute for both
the Senate bill and the House amendment. Except for clarifying,
clerical, and conforming changes, the differences are noted below:
[p. 19]
*******
ANIMAL FEED
The House amendment contained a provision amending the
anticancer clause of the food additives amendment and the color
[p. 20]
additive amendment of the Federal Food, Drug, and Cosmetic Act
by making this clause inapplicable to chemicals such as veterinary
drugs when used in feed for food-producing animals if the Secre-
tary finds (1) that under the conditions of use and feeding
-------
682
LEGAL COMPILATION—PESTICIDES
specified in the proposed labeling and reasonably certain to be
followed in practice, such additive will not adversely affect the
animals for which such feed is intended, and (2) that no residue
of the additive will be found (by methods of examination pres-
cribed or approved by the Secretary by regulations) in any edible
portion of the animal after slaughter or in any food such as milk
or eggs yielded by or derived from the living animal.
The Senate bill did not contain this provision.
The conference substitute adopts the House provision in this
respect.
[p
DEFINITION
The Senate bill contained a definition of the term "State."
The House amendment did not contain any such definition.
The conference report defines "State" appropriately for the
different sections of the act and revises the definition of the term
"Territory" to exclude the Commonwealth of Puerto Rico.
OREN HARRIS,
KENNETH A. ROBERTS,
LEO W. O'BRIEN,
PAUL G. ROGERS,
JOHN B. BENNETT,
PAUL F. SCHENCK,
ANCHER NELSEN,
Managers on the Part of the House.
[p. 27]
1.2i (4) CONGRESSIONAL RECORD, VOL. 108 (1962)
1.2i (4) (a) Aug. 23: Debated, amended, and passed Senate, pp.
17364-17422
[No Relevant Discussion on Pertinent Section]
1.2i (4) (b) Sept. 27: Amended and Passed House, pp. 21092,
21096-21097, 21099-21100
Mr. HARRIS. Mr. Speaker, I ask
unanimous consent to take from the
Speaker's table the Senate bill (S.
1552) to amend and supplement the
laws with respect to the manufacture
and distribution of drugs, and for
other purposes, strike out all after the
enacting clause, and insert in lieu
thereof the provisions of H.R. 11581,
to protect the public health by amend-
ing the Federal Food, Drug and Cos-
metic Act to assure the safety, efficacy,
and reliability of drugs, authorize
standardization of drug names, estab-
lish special controls for barbiturate and
stimulant drugs, and clarify and
strengthen existing inspection author-
ity with respect to any articles subject
-------
STATUTES AND LEGISLATIVE HISTORY
683
to the act; and to amend related laws,
just passed.
[p.21092]
The SPEAKER. The Clerk will re-
port the amendment.
The Clerk read as follows:
Amendment offered by Mr. Harris: strike
out all after the enacting clause and insert
the following:
[p.21096]
*****
"New Drug Clearance Procedure
"SEC. 104. (a) Section 605(a) of the Federal
Food, Drue, and Cosmetic Act (21 U.S.C.
355(a)), is amended to read as follows:
*****
"(f)(l) Clause (A) of paragraph (3) of sec-
tion 409(c) of such Act (21 U.S.C. 34.8(c)) is
amended by inserting before the semicolon at
the end thereof the following: ', except that
this proviso shall not apply with respect to the
use of a substance as an ingredient of feed for
animals which are raised for food production,
if the Secretary finds (i) that, under the condi-
tions of use and feeding specified in proposed
labeling and reasonably certain to be followed
in practice, such additive will not adversely
affect the animals for which such feed is in-
tended, and (ii) that no residue of the additive
will be found (by methods of examination pre-
scribed or approved by the Secretary by regu-
lations, which regulations shall not be subject
to subsections (f) and (g)) in any edible por-
tion of such animal after slaughter or in any
food yielded by or derived from the living
animal'.
"(2) Subparagraph (B) of paragraph (5) of
section 706(b) of such Act (21 U.S.C. 376(b))
is amended by inserting before the period at
the end of the Subparagraph a colon and the
following proviso: 'Provided, That clause (i)
of this Subparagraph (B) shall not apply with
respect to the use of a color additive as an
ingredient of feed for animals which are raised
for food production, if the Secretary finds that,
under the conditions of use and feeding speci-
fied in proposed labeling and reasonably certain
to be followed in practice, such additive will not
adversely affect the animals for which such
feed is intended, and that no residue of the
additive will be found (by methods of examina-
tion prescribed or approved by the Secretary
by regulations, which regulations shall not be
subject to subsection (d)) in any edible portion
of such animals after slaughter or in any food
yielded by or derived from the living animal'.
[p. 21097]
The amendment was agreed to.
[p. 21099]
The Senate bill was ordered to be
read a third time, was read the third
time and passed.
A motion to reconsider was laid on
the table.
The title was amended so as to read:
"An Act to protect the public health by
amending the Federal Food, Drug, and
Cosmetic Act to assure the safety, ef-
fectiveness, and reliability of drugs,
authorize standardization of drug
names, and clarify and strengthen ex-
isting inspection authority, and for
other purposes."
Mr. HARRIS. Mr. Speaker, I move
that the House insist upon the provi-
sions of the bill passed by the House
and request a conference with the
Senate.
The motion was agreed to.
The SPEAKER. The Chair appoints
the following conferees: Messrs. HAR-
RIS, ROBERTS of Alabama, O'BRIEN of
New York, ROGERS of Florida, BEN-
NET of Michigan, SCHENCK, and NEL-
SEN.
[p. 21100]
1.2i (4) (c) Oct. 3: Senate agrees to conference report, pp. 22137,
22039, 22041-22042, 22044-22045, 22049, 22050
DRUG INDUSTRY ACT OF 1962— and distribution of drugs, and for other
CONFERENCE REPORT 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 re-
port.)
(For conference report, see House
Mr. KEFAUVER. Madam Presi-
dent, I submit a report of the commit-
tee of conference on the disagreeing
votes of the two Houses on the amend-
ments of the House to the bill (S. 1552)
to amend and supplement the antitrust
laws with respect to the manufacture
-------
684
LEGAL COMPILATION—PESTICIDES
proceedings of Oct. 4, 1962, p. 22315,
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.
[p. 22037]
Mr. KEFAUVER.
SECTION 104 NEW DRUG CLEARANCE
PROCEDURE
There was only one difference be-
tween the Senate and House language
with respect to the new drug clearance
procedure. Both bills provided that a
new drug application cannot become
effective automatically under any cir-
cumstances but must be affirmatively
approved. Both provided that the Sec-
retary initially has 180 days—unless
further extended by agreement — in
which to decide to approve the appli-
cation or to give notice of an oppor-
tunity for a hearing; that the appli-
cant has 30 days in which to request a
hearing; and that the hearing would
have to begin within 90 days after
such 30 days, or within a total of 120
days after notice of the opportunity
of a hearing. The Senate bill did not
set forth any time period by which an
order would have to be entered follow-
ing the hearing. The House bill re-
quired the order to be issued in 90
days after the completion of the hear-
ing. A compromise was worked out to
the effect that the order would have
to be issued within 90 days, not after
the hearing, but after the date fixed
by the Secretary for filing final briefs.
This is the last step in the hearing
process prior to the final decision of
the Secretary.
I personally felt that the Senate bill,
which put no limit on the time that the
HEW could take after the hearing,
was preferable, but I trust that the
present provision will be adequate.
The conferees also accepted a House
provision which would correct a need-
less and unintentional inequity in the
application of the food additive anti-
cancer proviso to additives for animal
feed, while preserving in its full vigor
the consumer protection now afforded
by that provision.
The provision stipulates that the
anticancer proviso of existing law shall
not apply with respect to the use of a
substance—for example, a veterinary
drug—as an ingredient of feed for
animals which are raised for food pro-
duction, if the Secretary finds, first,
that, under the conditions of use and
feeding specified in proposed labeling
and reasonably certain to be followed
in practice, such additive will not ad-
versely affect the animals for which
such feed is intended; and, second,
that no residue of the additive will be
found in any edible portion of such
animals after slaughter or in any food
product of the living animal—such as
milk or eggs.
Another amendment would similarly
amend the basic act—which is the cor-
responding anticancer clause contained
in the color additive amendment of
1960 to the basic act.
It should be emphasized that where
a new drug is involved in these fields
and subsequent information and new
evidence raise a question as to its
safety, it can be withdrawn under the
new withdrawal and suspension pow-
ers provided for in section 102 of the
bill.
SECTION 105—CERTIFICATION OF
ALL ANTIBIOTICS
On this matter the conferees adopted
the Senate language with, however,
one important limitation contained in
the House bill; namely, that the re-
quirement for batch certification for
antibiotics not included in the present
law be limited to those "intended for
use by man." In other words, antibi-
otics not now subject to certification
which are solely intended for such
uses as veterinary purposes, animal
feed, et cetera, will not be required to
-------
STATUTES AND LEGISLATIVE HISTORY
685
go through batch-by-batch certifica-
tion. They will be subject to safety
and effectiveness tests under the new
drug procedures including the new
withdrawal powers provided in section
102.
I strongly urged that there should
be batch testing of antibiotics for use
by veterinarians in treating animals
and in animal feed as well as those
used for treating human beings, on the
theory that if an impure antibiotic is
used on a cow or a steer, the milk or
the meat might be infected, but I could
not prevail. That may be a subject of
legislative consideration in the next
session of Congress.
The conferees also agreed to an
amendment relating to proof of effec-
tiveness of antibiotics now on the mar-
ket which have been cleared for safety
through the new drug procedure of the
act but have not until now been subject
to batch-by-batch certification. The
purpose of this amendment is to facili-
tate the prompt certification of those
approximately 30 antibiotics that have
been approved for safety only under
the new drug provisions. Under the
certification procedure these antibiotics
will have to be both safe and effective
for their intended use. In the period of
transition, these antibiotics will be
approved for certification for the same
conditions that have been approved in
their new drug application. However,
the Food and Drug Administration
under this amendment is empowered to
review the adequacy of the evidence on
effectiveness and if it concluded that
there is a lack of substantial evidence
to support any or all of the existing
claims, it can change the certification
to eliminate these unsubstantiated
claims. There of course would be public
procedure with an opportunity for
hearings and judicial review afforded
the drug manufacturers before the
FDA began this type of action.
[p. 22039]
*****
The moral of the drug bill is that
even on an exceedingly complex issue
the legislative branch can perform in
the manner originally intended. With
only a small staff of competent profes-
sional personnel the Congress can
prove itself to be just as able as the
vast bureaucracy of the executive
branch, if not more so, to assume lead-
ership in the legislative process.
Madam President, I yield the floor.
The PRESIDING OFFICER (Mrs.
NEUBERGER in the chair). The question
is on agreeing to the conference report.
The report was agreed to.
During the delivery of Mr. KEPAU-
VER'S speech,
Mr. CARROLL. Madam President,
will the Senator from Tennessee yield?
Mr. KEFAUVER. I yield to the
Senator from Colorado, a distinguished
member of the Subcommittee on Anti-
trust and Monopoly, who worked long
and hard on the bill and whose labors
we all appreciate.
Mr. CARROLL. Madam President,
I desire to pay tribute to the long and
arduous work of the Senator from
Tennessee [Mr. KEFAUVER] and the
Senator from Michigan [Mr. HART],
and to the excellent work done by the
staff over a period of some 3 years, led
[p. 22041]
by Dr. John Blair, which has led to the
bill which is before the Senate today
for passage. No one can really fully
appreciate the scope of the bill unless
he has read the record or has attended
the hearings which took place through
many years.
S. 1552, a bill to amend and supple-
ment the laws with respect to the man-
ufacture and distribution of drugs, is
the result of 3 years of investigation
and research undertaken by the Anti-
trust and Monopoly Subcommittee of
which I am proud to be a member.
During much of this time we of the
subcommittee had very little support
and many obstacles were placed in our
path. It did not look as though we
could obtain a meaningful bill. During
all of this period, I am pleased to say
-------
686
LEGAL COMPILATION—PESTICIDES
that our chairman, the Senator from
Tennessee, never once was dissuaded
from his purpose.
As a result of the work done by our
committee members and by our com-
mittee staff—and unhappily because
of the great and tragic experience in
Europe with the experimental drug
thalidomide—we have before us today
a measure which marks a major
strengthening of the Federal drug
controls.
I am especially pleased that the bill
before the Senate, as approved by the
conference committee, embodies within
it the so-called Carroll-Javits amend-
ment, which requires for patient pre-
notification before experimental drugs
can be prescribed.
When we first presented this amend-
ment we were told that it was not
feasible. We persisted with our amend-
ment, however, because we felt that
when a man or his loved one consults
his family doctor, he has the right to
be assured that only safe and proven
medicines will be administered.
In the Senate version of the bill,
Senator JAVITS and I were successful
in obtaining an amendment—not all
that we sought, it is true—which would
insure that patients' rights would be
considered in the promulgation of reg-
ulations for the use of experimental
drugs.
Fortunately, happily, the House was
able to go even further in this respect
with the result that the bill before us
today provides that a doctor must ob-
tain a patient's permission to be treated
with an experimental drug. The only
exceptions to this lie in those cases
where a doctor feels obtaining such
permission would not be feasible or in
the patient's best interest.
Madam President, I am proud to
have worked shoulder to shoulder with
the Senator from Tennessee [Mr.
KEFAUVER] in this endeavor. I urge the
Senate to give this conference report
its speedy approval.
Madam President, I ask unanimous
consent to have printed at this point in
the RECORD an article entitled "Con-
ferees Vote Real Tightening Control
of Drugs," published in the Wall Street
Journal of today, October 3, 1962.
The PRESIDING OFFICER. Is
there objection?
There being no objection, the article
was ordered to be printed in the
RECORD, as follows:
CONFEREES VOTE BILL TIGHTENINO CONTROL OF
DRUGS—COMPROMISE MAKES FIRMS REGISTER
WITH AGENCY; FINAL PASSAGE LJKELY SOON
—SOME KENNEDY CLAUSES EASED
Washington.—A Senate-House conference
approved a bill tightening Federal controls over
the manufacture and marketing of prescription
drugs. Both Chambers are expected to approve
the measure by tomorrow and send it to the
White House.
The conferees accepted the Senate bill's re-
quirement that drug manufacturers register
with the Government and a House provision
that side-effect information to be included in
drug advertisements need only be "in briei
summary." But they rejected a Senate proposal
that the Government publish and distribute to
doctors, clinics, and libraries copies of the
printed material that the Government requires
be included in drug packages, containing de-
tailed information on the use and effects of
the drug.
The bill's controls are not as tight as those
proposed by the Kennedy administration, and
the measure omits some administration provi-
sions : New controls over barbiturates, ampheta-
mines, and biological drugs, and authority for
thorough Government inspection of factories
producing nonsprescription drugs.
PROVISIONS LISTED
These are the other major provisions of the
bill:
Thorough Federal inspection is authorized
for factories producing prescription drugs.
Drugs must be turned out under good manu-
facturing practices, must be safe, and meet
the quality and purity characteristics claimed
for them.
New drugs can't be marketed until specific
approval is granted by the Food and Drug
Administration, and a manufacturer must show
"substantial evidence" that a new drug will
have the effect claimed for it. The FDA is
given 180 days in which to consider a new-drug
application; an applicant has an additional 30
days to request a hearing if the FDA refuses
to approve the drug; the agency has 90 days
after that to hold a hearing, and the agency
has 90 days after the date set for filing final
legal briefs to issue a decision.
-------
STATUTES AND LEGISLATIVE HISTORY
687
The Government may withdraw from the
market any drug believed to present an "immi-
nent hazard" to the public.
Government controls over the manufacture of
certain antibiotics are extended to all of them.
Manufacturers must keep records of side
effects and ether experience with drugs and
make these records available to the FDA.
The common or official name of a drug must
be printed on the label prominently and in type
at least half as large as that of the brand name.
The FDA is authorized to determine a drug's
official name when the industry cannot agree.
EXPERIMENTAL DRUGS
In addition to these legal requirements, the
bill authorizes the FDA to include certain speci-
fied provisions in its regulations governing the
use of experimental drugs, those not yet ap-
proved for general public sale. Thalidomide,
the widely publicized German sleeping pill that
was linked to deformities in newborn babies,
was distributed in this country as such an ex-
perimental drug and was not approved by the
FDA. The bill's suggested new regulations,
largely similar to those proposed recently by
the FDA itself, would require doctors to:
Obtain a patient's permission to be treated
with an experimental drug, except w hen the
doctor feels obtaining such permission wouldn't
be feasible or in the patient's best interest.
Report to manufacturers and indirectly to
the Government on the results of experimental
drugs.
And administer experimental drugs only to
patients under their personal supervision.
Although the bill doesn't require the FDA to
issue these regulations, members of the con-
ference committee said it assumed the agency
•would agree to the recommendations.
[p. 22042]
Mr. KEFAUVER. Anyway, it will
all be in the RECORD. I ask unanimous
consent that the minority views, be-
ginning on page 33 of the committee
report, and the comparative analysis
to which the Senator from Nebraska
referred may be printed in the RECORD
at this point.
Mr. HRUSKA. Madam President, if
the Senator will yield, the comparative
analysis appears on several pages. I
would prefer to have that compiled in
one statement. It would be difficult to
take only one page and to get the com-
parative analysis.
Mr. KEFAUVER. Madam Presi-
dent, I ask unanimous consent to have
it included, when it is prepared.
Mr. HRUSKA. I thank the Senator.
Mr. KEFAUVER. And to further
aid in the understanding of the legis-
lative history, my statement of August
20, 1962.
The PRESIDING OFFICER. Is
there objection to the request by the
Senator from Tennessee?
There being no objection, the mate-
rial was ordered to be printed in the
RECORD, as follows:
VIEWS OF SENATORS ESTES KEPAUVEK, JOHN A.
CARROLL,! THOMAS J. DODD, PHILIP A. HABT,
AND EDWARD V. LONG
The undersigned voted to report favorably
S. 1552 as rewritten by the full Judiciary Com-
mittee because it does contain some provisions
which are improvements in the present law.
Moreover, in view of the great interest in the
subject, we felt the Senate as a whole should
have the opportunity of acting on certain
amendments which would strengthen the bill.
In the form in which it was originally intro-
duced on April 12, 1961, as well as the form in
which it was reported out by the Subcommittee
on Antitrust and Monopoly on March 8, 1962,
S. 1552 had three objectives:
1. To bring about reductions in the present
high prices of drugs.
2. To provide physicians with better and more
adequate information about drugs and correla-
tively to reduce the dissemination of information
which is false and misleading.
3. To insure that all drugs are of adequate
and acceptable quality.
In the form in which it was reported out by
the full Judiciary Committee, S. 1552 will have
only a very limited effect on prices, confined
[p. 22044]
to the minority of drugs which are not patented.
It will also have only a very limited effect in
improving the quality of information reaching
physicians. Its major result will be to improve
the quality of drugs.
While improvement in the quality of a prod-
uct is always desirable and S. 1552 should be
enacted for this purpose alone, the record is
clear that by any test and under any standard
the prices of most drugs are excessive and un-
reasonable. The record is also clear that physi-
cians are regularly inundated with a great mass
of advertising and promotional material, much
of which is misleading and some actually false.
Requiring drug plants to register their names
and addresses with the FDA, granting the
agency stronger inspection powers and requir-
ing drug plants to conform to current good
i Senator CARROLL concurs in all except amend-
ment No. 5 (see further individual views).
-------
688
LEGAL COMPILATION—PESTICIDES
manufacturing practice should tend to give
physicians greater confidence that, if they pre-
scribe by official or generic names, their patients
will receive drugs of adequate and acceptable
quality (sees. 3, 4, and 6 of S. 1652). Similarly,
the provision granting the Secretary of Health,
Education, and Welfare authority under cer-
tain conditions to establish the official names
should make for shorter and less complex ge-
neric names that physicians can remember,
pronounce, and spell (sec. 10). Because of these
changes it would be hoped that with the passage
of time more and more physicians will come to
prescribe by generic names. This should mean
lower prices for the patients of such doctors
for drugs which are not patented and are not
already sold on a generic-name basis, such as
phenobarbital, digitoxin, and others. The drugs
in which consumers can benefit from generic-
name prescribing probably represent less than
a fifth of all prescription sales.
Likewise, only three of the nine provisions
will contribute to providing physicians with
better information about drugs and reducing
the volume of misleading information. There
is, first, the requirement that HEW publish
the package inserts in convenient and readable
form and distribute them to physicians (sec 11).
Second is the provision authorizing the Com-
missioner of Patents to secure information on
drugs from the Department of Health, Educa-
tion, and Welfare (sec. 2). Presumably, if the
Patent Office, which has no physicians or
pharmacologists on its staff, is able to secure
information from HEW on the therapeutic
properties of drugs—which it is now able to
obtain only with the consent of the patent ap-
plicant—fewer patents may be issued. This in
turn should tend to reduce the number of prod-
ucts which could be the subject of high-pressure
blitz advertising and promotional campaigns
aimed at the doctors. Third is the provision
requiring the keeping of records and reports on
clinical testing, which should assist the FDA
in keeping off the market unsafe and ineffective
drugs or in prescribing proper and appropriate
warnings to puide physicians in their use
(sec. 7).
[p.22045]
AMENDMENT NO. 8—NEW DRUG CLEARANCE
PROCEDURE
Under the present law a new drug appli-
cation becomes effective automatically in 60
days unless it is disapproved or the Secretary
postpones its effective date "to such time (not
more than 180 days after the filing thereof) as
the Secretary deems necessary to enable him to
study and investigate the issue." Under S. 1562,
as reported by the Antitrust Subcommittee, no
time limit is imposed; the application would
not become effective until the Secretary had
determined that the drug is "safe for use and is
efficacious in use under conditions prescribed,
recommended, or suggested in the labeling
thereof." Under the bill as reported by the Judi-
ciary Committee the 60-day provision of the
present law is extended to 90 days, and if a
hearing is held, action pursuant to the hearing
need not be taken within the 180-day period, as
is required by regulation under the current law.
The need to give the physicians of the FDA
adequate time to appraise the safety and effec-
tiveness of drugs is dramatically illustrated by
the recent case example of thalidomide. This
drug, developed by the German firm, Chemie
Grunenthal, was extensively sold in Western
Europe, England, Canada, Brazil, Japan, and
other countries as a sedative. Since it produced
a deep sleep and did not have the "hangover
effects" of other sedatives, it achieved great
popularity and was manufactured literally by
the ton. Unfortunately, it also happens to have
horrible side effects. When given to expectant
mothers in early pregnancy, their babies may
be born with assorted malformations, particu-
larly with a condition called phocomelia, or
"seal limbs," because the hands and feet are
attached close to the body like flippers, with
little or no arms or legs. Medical authorities
estimate that from 3,500 to 5,000 malformed
babies resulting from the use of this drug will
have been born in Europe by this fall.
By the fall of 1961 the incidence in Europe of
these malformations, hitherto an exceedingly
rare phenomenon, had reached epidemic propor-
tions. In September 1961 four German univer-
sities set up a cooperative study which was re-
ported at a conference on November 18, 1961.
Dr. Widukind Lenz, a pediatrician with special
interest in genetics, discussed the possible role
of thalidomide (Contergan) in the deformity of
infants called seal limbs. Drs. R. A. Pfeiffer
and W. Kowenow reported a high statistical
significance connecting seal limbs with tha-
lidomide.
As the studies continued, irrefutable evidence
developed. In the February 3, 1962, issue of
the Lancet, Dr. Lenz wrote: "I have conclusive
evidence that Contergan (thalidomide) is tera-
togenic (monster producing) in man." This
evidence was based on studies of mothers who
disclosed before delivery that they had taken
thalidomide and in which the infants showed
typical malformations ; 65 cases in which the
exact date of the prescription coincides with
the time of development of the malformed
organs; 5 series of consecutive cases collected
in hospitals by gynecologists and pediatricians.
Dr. Lenz continued to receive reports connecting
the deformed babies with the prescription of
the drug for the mothers at the rate of 3 to 10
per day.
Dr. A. L. Spiers, a Scottish physician,
searched the prescription records of mothers
of deformed babies to determine whether and
when the expectant mothers had taken thalido-
-------
STATUTES AND LEGISLATIVE HISTORY
689
mide. Reporting his findings in the Lancet of
February 10, 1962, he stated :
"During the past year 10 babies with major
limb defects were born in Stirlingshire ma-
ternity units. At least eight of the mothers had
thalidomide prescribed for them in the early
weeks of pregnancy. This confirms a similar as-
sociation found in Europe and elsewhere."
The drug was withdrawn from the German
market on November 27, 1961, and from the
British market on December 2, 1961. It was not
withdrawn from the Canadian market until
March 2, 1962, and some druggists were still
selling their shelf supplies in April. It was
taken off the market in Belgium on June 14,
1962, after one distraught mother in Liege had
been charged with infanticide for destroying
her malformed baby.
Meanwhile, well before there was any basis
for associating the drug with any particular
side effects, the American licensee for the
product, Wm. S. Merrell, filed its new drug
application on September 12, 1960. It was to be
sold in the United States under the trade
name, Kevadon. Ironically, the proposed labeling
stressed the value of the drug in combating
nausea in pregnancy.
A few months later there appeared in the
British Medical Journal of January 14, 1961,
a communication from the clinical research
department of the British licensee, Distillers
Co., reporting instances of patients receiving
thalidomide who had developed "symptoms and
signs suggestive of peripheral neuritis" (i.e., in-
flammation of the nerves in the feet and hands).
Noting this report and other reports of damage
to adult nervous tissue, which is notably re-
sistant to injury, the medical officer of the
FDA handling the application, Dr. Frances
Kelsey, suspected the likelihood of more serious
damage to embryonic nervous tissue. According-
ly, she kept delaying approval of the application
on the grounds that the application was incom-
plete and that new information was required.
This resistance was in the face of strong
pressure by the company. The following synop-
sis, submitted by HEW, reveals more graph-
ically than could any general description, the
types of tactics employed to get a new drug
application approved, and the difficulties under
which the medical officers operate under condi-
tions where approval is automatic within a
given time period unless FDA acts to the
contrary:
"The new drug application was received on
September 12, 1960. FDA medical officers found
it incomplete and inadequate to demonstrate
safety on November 10, 1960.
"Between that date and February 23, the
firm contacted FDA medical officers 11 times
and submitted additional information intended
to establish safety of the product.
"On February 23, 1961, FDA again found
the application incomplete. By this time it had
learned from the medical literature of reports
of neuorological toxicity from the drug. FDA
called this to the firm's attention.
"The firm made 11 more contacts with FDA
medical officers between that time and May 11,
1961. On April 19, 1961, Mr. Murray of the firm
advised Dr. Ralph Smith of FDA that he (Mur-
ray) thought some pressure should be asserted.
Murray said he wanted a "yes or no" decision.
On May 9, 1961, Mr. Murray called Dr. Ralph
Smith and referred to a letter from Dr. Frances
Kelsey, an FDA officer, as somewhat libelous.
"On May 11, 1961, Mr. Murray of the firm
met with three of FDA's medical officers. They
advised him that FDA needed evidence that
the drug would be safe during pregnancy. FDA
felt that the evidence in the petition before us
was inadequate to support labeling: which
stressed the value of the drug in pregnancy.
"The firm made 14 contacts with FDA medi-
cal officers between this time and September 7,
1961, designed to expedite clearance of its new
drug application.
"On September 7, 1961, Mr. Murray of the
firm arranged a conference with FDA medical
officers at which some clinicians who had in-
vestigated the drug for the firm reported their
experience with it. FDA medical officers again
pointed out the inadequate evidence on safety
of the drug in pregnancy.
"The firm made 10 more contacts with FDA
between this time and November 30, 1961, de-
signed to get the drug cleared for marketing.
"November 30, 1961, Mr. Murray of the firm
advised FDA that the drug had been withdrawn
from the German market because of reports
that it caused birth defects in infants whose
mothers had been taking the drug.
"On March 8, 1962, the firm withdrew the
new drug application.
"Between September 12, 1960, when the ap-
plication was first submitted and November 30,
1961, when the firm advised of the birth ab-
normalities, William S. Merrell contacted FDA's
Bureau of Medicine 50 times in an effort to get
this drug on the American market and a number
of the efforts to get the new drug application
approved were very vigorous."
The fact that thalidomide was not approved
for sale in the United States was due in part
to the insight and eourag-e of FDA's medical
officer and in part to the coincidence that just
about the time that the grounds on which the
application could be held to be incomplete were
being exhausted, the reports began to appear
in the European medical journals associating
the drug with the malformed births. Had these
reports appeared only a few months later, there
is a strong probability that the drug: would
have been released for sale in the United
States in 1961.
It could then, of course, have been ordered
off the market, but what of the damage that
would have been done in the interim? It is this
-------
690
LEGAL COMPILATION—PESTICIDES
very practice under which the FDA approves
the marketing of a drug, only to have to take
it off the market later, that constitutes one of
the most serious weaknesses of the present law
—a weakness which will only be slightly re-
lieved under the bill reported by the committee.
The very fact that a drug is new usually means
that there is little in the way of independent
and objective clinical studies to guide the FDA
physicians in their work. Because of this lack
of information and also because of the pressures
engendered by the automatic approval require-
ment, the FDA has released too many drugs
for sale only to have to take them off the market
later as new information concerning side effects
develops. Under this procedure it is the Ameri-
can people who unknowingly serve as guinea
pigs for experiments by the drug companies.
The seriousness of the problem is indicated by
the table presented below which lists the new
drugs whose new drug applications were sus-
pended or withdrawn after mid-1958. Particu-
larly to be noted are those drugs with side
effects which can lead to death—blood dyscra-
sias, carcinogenic effects, liver damage, and
hepatitis. The table should constitute conclusive
evidence that the medical officers of the FDA,
who are trying to protect the American people
from drugs with dangerous side effects, should
have an adequate time period in which to assure
themselves that the drug is safe, and that appli-
cations should not become effective automati-
cally during any time period. If a drug company
feels that the delay in his application is arbi-
trary or capricious, it, of course, has recourse
to the courts.
[p. 22047]
[From the office of Senator Estes Kefauver,
Democrat, of Tennessee, AUK. 20, 1962J
SENATOR KEFAUVER HAILS JUDICIARY COMMIT-
TEE ACTION IN ADOPTING STRENGTHENING
AMENDTMENTS TO DRUO BILL
Senator ESTES KBFAUVER today hailed the
action by the Senate Judiciary Committee in
adopting strengthening amendments to S. 1652,
the drug industry bill, as "a great step for-
ward." "The passage of this bill," he stated,
"should go a long way toward assuring the
American people that drugs are not only safe
but will do what is claimed for them.
"By adopting most of the substance of the
President's strong recommendations sent to
Chairman EASTLAND on August 4," the Senator
said, "the committee has reported out a bill
which should not only result in better, safer
and more effective drugs, but in addition should
provide physicians with honest information
concerning their properties and prevent the
dissemination of false and misleading infor-
mation to doctors."
The Senator pointed out that the bill will thus
accomplish two of the three objectives which
he had in mind in introducing the measure on
April 12, 1961, following an extensive 2-year
investigation of the industry. In addition to pro-
viding for safer drugs and better information
to doctors, he had hoped to bring about price
reductions. By making it easier and safer for
physicians to prescribe by generic names, the
present bill should result in lower prices for
nonpatented drugs. "But", he pointed out,
"there is nothing in the committee's bill to
reduce the present high and excessive prices of
patented drugs, which constitute about 60 per-
cent of all prescription sales. I hope to achieve
this objective by offering amendments on the
floor of the Senate to require compulsory licens-
ing of prescription drugs where the price to the
druggist represents a markup of more than 600
percent of the factory cost (including research)
and to require that patent and license agree-
ments on drugs be filed with the Commissioner
of Patents to be available to the antitrust
agencies."
In addition, the Senator stated that he in-
tended to introduce an amendment explicitly
granting the FDA authority to require animal
testing on drugs before they are given to
humans, either in clinical testing or through
sales on the market.
"But on nine specific points," the Senator
added, "S. 1552 as amended in general accor-
dance with the President's recommendations is
generally the same as the bill in its original
form, as introduced on April 12, 1961. These
nine points are: efficacy, advertising, new drug
clearance procedure, determination of generic
names, certification of antibiotics, package in-
serts, labeling requirements, factory inspection,
and quality manufacturing controls. A listing
comparing the original with the present version
of S. 1552 on these points is attached.
PROVISIONS IN 8. 1662 (AS SUPPLEMENTED BY
THE COMMITTEE AMENDMENTS) SIKILAE IN
SUBSTANCE TO 8. 1662, AS INTRODUCED ON
APRIL 12,1961.
t. New drug eleanutet procedure
Although the Committee amendment does not
go as far as S. 1552 in its original form, which
would have eliminated the time limit altogether
for approval of a new drug application, it does
away with the automatic approval feature of
the present law and greatly extends the time
period from the present 60 to 180 days, plus
120 more if the applicant seeks a hearing.
* * # * *
[p. 22050]
-------
STATUTES AND LEGISLATIVE HISTORY
691
1.2i (4) (d) Oct. 4: House agrees to conference report, pp. 22323-
22325.
Mr. ROBERTS.
*****
Mr. Speaker, there were a few items
in the House bill which had no cor-
responding provision in the Senate bill
and vice versa, such as the animal
feed provision in the House bill, con-
fidentiality of information in the House
bill, effect of State laws in the House
bill, or registration of producers of
drugs in the Senate bill, publication by
the Department of Health, Education,
and Welfare of drug information in
the Senate bill as well as information
on patents in the Senate bill.
These items were worked out to the
satisfaction of the conference com-
mittee.
*****
[p. 22323]
Mr. Speaker, I move the previous
question.
The previous question was ordered.
The SPEAKER pro tempore (Mr.
HARRIS). The question is on agreeing
to the conference report.
The question was taken.
Mr. ROBERTS of Alabama. Mr.
Speaker, I object to the vote on the
ground that a quorum is not present
and make the point of order that a
quorum is not present.
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 347, nays 0, not voting 88,
as follows:
to.
So the conference report was agreed
[p. 22325]
1.2j HEART DISEASE, CANCER, STROKE AND KIDNEY
DISEASE AMENDMENTS OF 1970
October 30,1970, P.L. 91-515, Title VI, Section 601 (d) (1) 84 Stat. 1311
(d) (1) Subsection (g) of section 408 of the Food, Drug, and
Cosmetic Act87 is amended by striking out "as compensation for
their services a reasonable per diem, for time actually spent in
the work of the committee, and shall in addition be reimbursed
for their necessary traveling and subsistence expenses while so
serving away from their places of residence." after "shall receive"
and by inserting in lieu thereof "compensation and travel expenses
in accordance with subsection (b) (5) (D) of section 706."
[p. 1311]
1.2j (1) HOUSE COMMITTEE ON INTERSTATE AND FOR-
EIGN COMMERCE
H.R. REP. No. 91-1297, 91st Cong., 2d Sess. (1970)
[No Relevant Discussion on Pertinent Section]
1.2j (2) SENATE COMMITTEE ON LABOR AND PUBLIC
WELFARE
S. REP. No. 91-1090, 91st Cong., 2d Sess. (1970)
[No Relevant Discussion on Pertinent Section]
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692 LEGAL COMPILATION—PESTICIDES
1.2j (3) COMMITTEE OF CONFERENCE
H.R. REP. No. 91-1590, 91st Cong., 2d Sess. (1970)
[No Relevant Discussion on Pertinent Section]
1.2j (4) CONGRESSIONAL RECORD, VOL. 116 (1970)
1.2j (4) (a) Aug. 12: Amended and passed House, p. 28532
[No Relevant Discussion on Pertinent Section]
1.2j (4) (b) Sept. 9: Amended and passed Senate, p. 31013
[No Relevant Discussion on Pertinent Section]
1.2j (4) (c) Oct. 13: House agrees to conference report, pp. 36589-
36591
[No Relevant Discussion on Pertinent Section]
1.2j (4) (d) Oct. 14: Senate agrees to conference report, pp.
36888-36892
[No Relevant Discussion on Pertinent Section]
1.2k COMPREHENSIVE HEALTH MANPOWER TRAINING
ACT OF 1971
November 18, 1971, P.L. 92-157 Title III, §303(a), 85 Stat. 464
To amend title VII of the Public Health Service Act to provide increased man-
power for the health professions, and for other purposes.
AN ACT
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
TITLE I—AMENDMENTS TO TITLE VII OF THE PUBLIC
HEALTH SERVICE ACT
SHORT TITLE ; REFERENCES TO ACT
SEC. 101. (a) This title may be cited as the "Comprehensive
Health Manpower Training Act of 1971".
(b) Whenever in this title an amendment or repeal is expressed
in terms of an amendment to, or repeal of, a section or other pro-
vision, the reference shall be considered to be made to a section or
other provision of the Public Health Service Act.
[p.l]
-------
STATUTES AND LEGISLATIVE HISTORY 693
TITLE III—MISCELLANEOUS
# * * * *
TECHNICAL AMENDMENTS TO OTHER ACTS
SEC. 303. (a) The fourth sentence of section 408(g) of the Food,
Drug, and Cosmetic Act is amended by striking out ", which the
Secretary shall by rules and regulations prescribe,". r „_,
Lp. ooj
1.2k(l) HOUSE COMMITTEE ON INTERSTATE AND
FOREIGN COMMERCE
H.R. REP. No. 92-258, 92d Cong. 1st Sess. (1971)
[No Relevant Discussion on Pertinent Section]
1.2k(2) SENATE COMMITTEE ON LABOR AND
PUBLIC WELFARE
S. REP. No. 92-251, 92d Cong., 1st Sess. (1971)
[No Relevant Discussion on Pertinent Section]
1.2k(3) COMMITTEE OF CONFERENCE
H.R. REP. No. 92-578, 92d Cong., 1st Sess. (1971)
[No Relevant Discussion on Pertinent Section]
1.2k(4) CONGRESSIONAL RECORD, VOL. 117 (1971):
1.2k(4) (a) July 1: Considered and passed House
[No Relevant Discussion on Pertinent Section]
1.2k(4) (b) July 14: Considered and passed Senate, amended
[No Relevant Discussion on Pertinent Section]
1.2k(4) (c) Oct. 19: Senate agreed to conference report
[No Relevant Discussion on Pertinent Section]
1.2k(4) (d) Nov. 9: House agreed to conference report
[No Relevant Discussion on Pertinent Section]
1.21 FEDERAL ENVIRONMENTAL PESTICIDE CONTROL
ACT OF 1972
October 21, 1972, P.L. 92-516, § 3(3), 86 Stat. 998
AN ACT
To amend the Federal Insecticide, Fungicide, and Rodenticide 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 this Act
may be cited as the "Federal Environmental Pesticide Control Act
of 1972". _ _
[p. 1]
-------
694 LEGAL COMPILATION—PESTICIDES
AMENDMENTS TO OTHER ACTS
SEC. 3. The following Acts are amended by striking out the terms
"economic poisons" and "an economic poison" wherever they
appear and inserting in lieu thereof "pesticides" and "a pesticide"
respectively: *****
(3) The Federal Food, Drug, and Cosmetic Act, as amended
(21U.S.C. SOletseq.). _ _„
LP- ^oj
1.21(1) HOUSE COMMITTEE ON AGRICULTURE
H.R. REP. No. 92-511, 92d Cong., 1st Sess. (1971)
[No Relevant Discussion on Pertinent Section]
1.21(2) SENATE COMMITTEE ON AGRICULTURE
AND FORESTRY
S. REP. No. 92-838, 92d Cong., 2d Sess. (1972)
[No Relevant Discussion on Pertinent Section]
1.21(3) SENATE COMMITTEE ON COMMERCE
S. REP. No. 92-970, 92d Cong., 2d Sess. (1972)
[No Relevant Discussion on Pertinent Section]
1.21(4) COMMITTEE OF CONFERENCE
H.R. REP. No. 92-1540, 92d Cong., 2d Sess. (1972)
[No Relevant Discussion on Pertinent Section]
1.21(5) CONGRESSIONAL RECORD:
1.21(5)(a) VOL. 117 (1971), Nov. 8, 9: Considered and passed
House;
[No Relevant Discussion on Pertinent Section]
1.21(5)(b) VOL. 118 (1972), Sept. 26: Considered and passed
Senate, amend;
[No Relevant Discussion on Pertinent Section]
1.21(5)(c) VOL. 118 (1972), Oct. 5; Senate agreed to conference
report;
[No Relevant Discussion on Pertinent Section]
1.21(5)(d) VOL. 118 (1972), Oct. 12: House agreed to conference
report;
[No Relevant Discussion on Pertinent Section]
-------
STATUTES AND LEGISLATIVE HISTORY 695
1.8 STUDIES OF EFFECTS IN USE OF
CHEMICALS, AS AMENDED
16 U.S.C. §742d-l
§ 742d-l. Studies of effects in use of chemicals
The administrator of the Environmental Protection Agency
is authorized and directed to undertake comprehensive contin-
uing studies on the effects of insecticides, herbicides, fungicides,
and pesticides, upon the fish and wildlife resources of the United
States, for the purpose of determining the amounts, percentages,
and formulations of such chemicals that are lethal to or injuri-
ous to fish and wildlife and the amounts, percentages, mixtures,
or formulations that can be used safely, and thereby prevent
losses of fish and wildlife from such spraying, dusting, or other
treatment. (Pub. L. 85-582, § 1, Aug. 1, 1958, 72 Stat. 479; 1970
Reorg. Plan No. 3, § 2 (a) (2) (i), eff. Dec. 2. 1970, 35 F.R. 15623
84 Stat. .)
1.3a PESTICIDE RESEARCH ACT
August 1, 1958, P.L. 85-582, 72 Stat. 479
AN ACT
To authorize and direct the Secretary of the Interior to undertake continuing
studies of the effects of insecticides, herbicides, fungicides and other pesti-
cides, upon fish and wildlife for the purpose of preventing losses of those
invaluable natural resources following application of these materials and to
provide basic data on the various chemical controls so that forests, croplands,
wetlands, rangelands and other lands can be sprayed with minimum losses
of fish and wildlife.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, That the Sec-
retary of the Interior is authorized and directed to undertake
comprehensive continuing studies on the effects of insecticides,
herbicides, fungicides and pesticides, upon the fish and wildlife
resources of the United States, for the purpose of determining
the amounts, percentages, and formulations of such chemicals
that are lethal to or injurious to fish and wildlife and the amounts,
percentages, mixtures, or formulations that can be used safely,
and thereby prevent losses of fish and wildlife from such spray-
ing, dusting or other treatment.
Sec. 2. The sum of $280,000 per annum is hereby authorized
to be appropriated to carry out the objectives of this Act.
Approved August 1,1958.
[p. 479]
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696 LEGAL COMPILATION—PESTICIDES
1.3a (1) SENATE COMMITTEE ON INTERSTATE AND FOR-
EIGN COMMERCE
S. REP. No. 1592, 85th Cong., 2d Sess. (1958)
RESEARCH ON THE EFFECTS OF INSECTICIDES ON
FISH AND WILDLIFE
MAY 19,1958.—Ordered to be printed
Mr. MAGNUSON, from the Committee on Interstate and Foreign
Commerce, submitted the following
REPORT
[To accompany S. 2447]
The Committee on Interstate and Foreign Commerce, to whom
was referred the bill (S. 2447) to authorize and direct the Secre-
tary of the Interior to undertake continuing studies of the effects
of insecticides, herbicides, and fungicides upon fish and wildlife
for the purpose of preventing losses of those invaluable natural
resources following spraying, and to provide basic data on the
various chemical controls so that forests, croplands, and marsh-
es can be sprayed with minimum losses of fish and wildlife, hav-
ing considered the same, report favorably thereon with amend-
ments and recommend that the bill, as amended, do pass.
PURPOSE OP THE BILL
S. 2447, as amended and approved by unanimous vote of your
committee, would authorize and direct the Secretary of the Inter-
ior to undertake continuing studies of the effects of insecticides,
herbicides, fungicides, and pesticides upon fish and wild life for
the purpose of preventing losses of those invaluable natural
resources following application of these materials, and to provide
basic data on various chemical controls. This research and study
will, it is anticipated determine the amounts and percentages of
such formulations and chemicals that may be used on wet lands,
rangelands, and other lands with a minimum loss of fish and wild-
life.
COMMITTEE ACTION
Public hearings were held by our committee on this legislation,
and everyone desiring to testify was given an opportunity to be
heard. Appearing and speaking in favor of this legislation were
the following: Hon. Lee Metcalf, United States Representative
[p.l]
-------
STATUTES AND LEGISLATIVE HISTORY 697
from the First District of Montana; Lansing A. Parker, Assis-
tant. Director for Wildlife, Bureau of Sports Fisheries and Wild-
life, Department of the Interior; James D. Dewitt, Chief Chemist,
Bureau of Sports Fisheries and Wildlife, Department of the Inter-
ior ; John H. Baker, president, National Audubon Society; Charles
E. Jackson, general manager, National Fisheries Institute; H. S.
Mosebrook, forester of the American Pulpwood Association;
Charles H. Callison, conservation director, National Wildlife Fed-
eration; and Kenneth Pomeroy, representing the American For-
estry Association. This bill is endorsed by farm groups, timber
and logging industries, commercial fisheries, sportsmen, Federal
and State officials.
NEED FOR THIS LEGISLATION
The current situation is, in a large part, due to the phenomenal
growth in the use of new pesticidal compounds developed since
World War II. The usefulness of these chemicals in combating
ravages of insect pests is evidenced by reports that over 750 mil-
lion pounds of pesticides having a value of over $256 million are
produced in the United States each year. About two-thirds of this
production is for domestic use on some 65 million acres of the
Nation's land and water.
It is reported that there are over 6,000 aircraft, flying 541,000
hours, used to distribute or spray around 100 million gallons of
liquid formulations, a major share of which are insecticidal.
The effects of these sprays, or dustings, has not only killed
insects, but also destroyed wild and domestic animals and birds.
A Florida operation to control sandflies resulted in the death of an
estimated 1 million fish of 30 different species. A spray used to
destroy tree-girdling mice has killed other mammals and birds.
In March of 1958, approximately 3,000 geese died from eating
treated grain used in Klamath Basin, Oreg., mouse-control cam-
paign. Water runoff from some sprays on lands has killed fish.
There is grave concern as to whether chemicals used to kill fire
ants will even destroy earthworms, a major source of food for
woodcock wintering in those areas. In Washington State, there
has been damage to upland birds. In Montana, on the Yellow-
stone River, there was extensive damage to fish following appli-
cation of DDT as part of the spruce budworm control program.
A census of fish in seven Montana trout streams showed a loss
of from 70 to 80 percent as a result of this spray.
This all points up to a pressing and urgent need for research
studies to provide basic information which can be used as a guide
to the future development and application of such formulations.
-------
698 LEGAL COMPILATION—PESTICIDES
At the present time, the effects of many formulations are not
fully known or understood.
Your committee believes this Congress should set in motion
a research program in this all-important field.
This legislation carries no appropriation with it.
AGENCY COMMENTS
Department of the Interior
The Department of the Interior favors enactment of this legis-
lation, with certain amendments. All amendments suggested by
the Interior Department have been incorporated into the bill,and
are shown below.
[p. 2]
Section 2 of the bill should be eliminated. This section would
limit annual appropriations to the sum of $280,000.
The Department of Interior states:
In our opinion, an adequate research program for the
study of wildlife pesticide relationships probably would
exceed this amount for certain years, and we believe that an
arbitrary ceiling on appropriations for a program of this
type would not be advisable.
In addition, the Department suggested the following perfecting
amendments:
(1) Page 1, revise line 5 to read "of insecticides, herbicides,
fungicides, and pesticides upon the fish and".
(2) Page 2, revise line 1 to read "determining the amounts,
percentages, and formulations of such chemicals".
(3) Page 2, revise line 3 to read "amounts, percentages, mix-
tures, or formulations that can be used safely,".
(4) Page 2, revise line 5 to read "spraying, dusting, or other
treatments."
(5) Amend the title of the bill to read:
To authorize and direct the Secretary of the Interior to
undertake continuing studies of the effects of insecticides,
herbicides, fungicides, and other pesticides upon fish and
wildlife for the purpose of preventing losses of those invalu-
able natural resources following application of these mate-
rials, and to provide basic data on the various chemical con-
trols so that forests, croplands, wet lands, rangelands, and
other lands can be sprayed, dusted, or otherwise treated with
minimum losses of fish and wildlife.
The report from the United States Department of the Interior
on S. 2447 is appended hereto.
-------
STATUTES AND LEGISLATIVE HISTORY 699
Comptroller General of the United States
The Comptroller General of the United States, in his letter
dated July 19,1957, stated:
We have no information relative to the necessity for, or
advisability of, the additional legislation proposed by S. 2447
and we, therefore, make no recommendation with respect to
its enactment.
Department of Justice
The United States Department of Justice, in their letter dated
July 10,1957, stated:
The bill has been examined, but, since the subject matter
thereof is not related to any of the activities of the Depart-
ment of Justice, we would prefer not to offer any comment
concerning it.
Department of Health, Education, and Welfare
The Department of Health, Education, and Welfare did not
reply to the committee's request for comments on this bill.
Agriculture Department
The Agriculture Department did not reply to the committee's
request for comments on this legislation.
[p. 3]
DEPARTMENT OF THE INTERIOR,
OFFICE OF THE SECRETARY,
Washington, July 12,1957.
Hon. WARREN G. MAGNUSON,
Chairman, Committee on Interstate and Foreign Commerce,
United States Senate, Washington, D. C.
DEAR SENATOR MAGNUSON: Your committee has requested a report on
S. 2447, to authorize and direct the Secretary of the Interior to undertake
continuing studies of the effects of insecticides, herbicides, and fungicides upon
fish and wildlife for the purpose of preventing losses of those invaluable
natural resources following spraying, and to provide basic data on the various
chemical controls so that forests, croplands, and marshes can be sprayed with
minimum losses of fish and wildlife.
We are agreeable to the enactment of this proposed legislation, although
we believe the Fish and Wildlife Act of 1956 (70 Stat. 1119) and our general
authority in this field provide sufficient authority to carry out the program
contemplated by this bill. Enactment of specific legislation on this subject
would, of course, express the interest of the Congress in this particular pro-
gram that we consider to be vital to conservation of the Nation's fish and
wildlife resources. Our budget estimates for fiscal year 1958 contain an item
for pesticide studies on wildlife.
Sportsmen, conservationists, foresters, and farmers alike are concerned
over the tremendous increases in pesticide applications to eliminate insects,
-------
700 LEGAL COMPILATION—PESTICIDES
weeds, diseases, and other pests. Each year more acreage is being treated
with better and more efficient pesticides. Particularly impressive are the large
numbers of extensive forest DDT spraying programs now being conducted
yearly. Over 3.4 million acres of forests were sprayed last year, and more will
be sprayed this year. Last year 65 million acres—more than one-sixth of the
United States cropland—were treated with pesticides, the total amount of
formulated pesticides being 3 billion pounds. The cost of applying these pesti-
cides amounted to $256 million. Yet crop losses on untreated areas were esti-
mated at $7.5 billion.
The importance of our forests and agricultural crops is unquestioned. Both
are vitally needed. Likewise, insect and other pesticide-control operations are
necessary. However, pesticide-control programs have gone ahead without ade-
quate information on the effects which the pesticides have on fish and wildlife
resources. A multi-billion-dollar recreation and commercial fishery industry
of interest to more than 30 million Americans is involved.
The seriousness of the effects of insecticides on wildlife is emphasized by
extensive spraying for the control of Dutch elm disease, which is now taking
place. DDT is being used at as much as 10 times the concentration that can be
tolerated by wildlife, and the resultant death of thousands of birds has aroused
citizens in many parts of the country. Another current problem is the invasion
of alfalfa fields by the yellow aphid. Required insecticidal treatments could
have an appallingly serious effect on bird populations, as the yellow aphid has
spread over millions of acres in the last 3 or 4 years.
In 1954, the CAA estimated that 31 million acres of land were sprayed by
6,000 airplanes during 541,000 hours of flying. In the Mirimichi River drainage
of New Brunswick, Canada, following the airplane spraying of a DDT-oil
[p. 4]
solution to control a forest pest, the spruce budworm, serious losses of salmonid
fish occurred. Heavy depletions in fish populations also occurred in the Yellow-
stone River drainage of Montana and Wyoming in 1955, following similar
control operations for the spruce budworm. In the 100-mile section of the river
affected, the value of the fishery has been estimated at $20,000 per mile annu-
ally, giving the fish an annual value (in terms of expenditures by fishermen)
of $2 million. These instances of fish losses emphasize the need for more
knowledge upon which to predict the effects of DDT applications. When a DDT
spray operation is contemplated, the sponsors of the project should be able to
obtain advice from Federal and State conservation officials on physiological
problems, methods of application, formulations, and the timing of applications
to minimize fish and wildlife losses.
In view of our responsibilities under treaty obligations with Canada and
Mexico for the protection and management of migrating birds, including water-
fowl, and for the protection and management of fish in Federal waters, funds
are necessary to support research to determine the effects of insecticides on
fish and wildlife. Sufficient basic research has not been accomplished to predict
losses or to properly advise operating agencies on means of obtaining effective
control and, at the same time, avoiding unnecessary fish and wildlife mortality.
Combined laboratory and field investigations in cooperation with other gov-
ernmental agencies, such as the United States Forest Service, are necessary to
obtain the needed facts. Among the pesticide-wildlife relationships that should
be studied are the following:
(1) Tests of toxicity of new insecticides for birds, mammals, and fish.
-------
STATUTES AND LEGISLATIVE HISTORY 701
(2) Development of diagnostic tests to permit determinations as to
whether or not animals were killed by specific insecticides or other pesti-
cides.
(3) Studies of application of insecticides in forest pest control, such
as hark and spruce budworm.
(4) Studies of the effects on fish and wildlife of controlling the white-
fringed beetle, Japanese beetle, grasshoppers, Mormon crickets, corn
borer, and a host of other farm pests in all regions.
(5) Marsh studies on mosquito production and control in relationship
to waterfowl habitat preservation. These studies would involve develop-
ment of alternate methods of controlling mosquitoes, as well as testing
new insecticides as to their effects on waterfowl and other desirable forms
of marsh wildlife.
If favorable action is taken on this bill, we recommend that section 2 be
eliminated therefrom. This section would limit annual appropriations for these
purposes to the sum of $280,000. In our opinion, an adequate research program
for the study of wildlife-pesticide relationships probably would exceed this
amount for certain years, and we believe that an arbitrary ceiling on appropri-
ations for a program of this type would not be advisable. In addition, we sug-
gest the following perfecting amendments:
(1) Page 1, revise line 5 to read: "of insecticides, herbicides, fungicides,
and pesticides upon the fish and".
(2) Page 2, revise line 1 to read: "determining the amounts, percent-
ages, and formulations of such chemicals".
[p. 5]
(3) Page 2, revise line 3 to read: "amounts, percentages, mixtures, or
formulations that can be used safely,".
(4) Page 2, revise line 5 to read: "spraying, dusting, or other treat-
ments."
(5) Amend the title of bill to read: "To authorize and direct the Secre-
tary of the Interior to undertake continuing studies of the effects of
insecticides, herbicides, fungicides, and other pesticides upon fish and
wildlife for the purpose of preventing losses of these invaluable natural
resources following application of these materials, and to provide basic
data on the various chemical controls so that forests, croplands, wet lands,
rangelands, and other lands can be sprayed, dusted, or otherwise treated
with minimum losses of fish and wildlife."
The Bureau of the Budget has advised us that there would be no objection
to the submission of this report to your committee.
Sincerely yours,
HATFIEID CHILSON,
Under Secretary of the Interior.
[p. 6]
-------
702 LEGAL COMPILATION—PESTICIDES
1.3a (2) HOUSE COMMITTEE ON MERCHANT MARINE AND
FISHERIES
H.R. REP. No. 2181, 85th Cong., 2d Sess. (1958)
AUTHORIZING RESEARCH ON INSECTICIDES, HERBI-
CIDES, FUNGICIDES, AND OTHER PESTICIDES BY THE
SECRETARY OF THE INTERIOR
JULY 16, 1958.—Committed to the Committee of the Whole House on the State
of the Union and ordered to be printed
Mr.BoNNER, from the Committee on Merchant Marine and
Fisheries, submitted the following
REPORT
[To accompany S. 2447]
The Committee on Merchant Marine and Fisheries, to whom
was referred the bill (S. 2447) to authorize and direct the Secre-
tary of the Interior to undertake continuing studies of the effects
of insecticides, herbicides, fungicides, and other pesticides upon
fish and wildlife for the purpose of preventing losses of those
invaluable natural resources following application of these
materials and to provide basic data on the various chemical con-
trols so that forests, croplands, wetlands, rangelands, and other
lands can be sprayed with minimum losses of fish and wildlife,
having considered the same, report favorably thereon with
amendment and recommend that the bill as amended do pass.
The amendment is as follows:
On page 2, after line 8, add another section, reading as follows:
Sec. 2. The sum of $280,000 per annum is hereby author-
ized to be appropriated to carry out the objectives of this Act.
PURPOSE OF THE BILL
The purpose of the bill S. 2447 is to express the intent of the
Congress that the Secretary of the Interior increase his efforts
to determine the effects upon fish and wildlife of the many lethal
forms of insecticides, pesticides, and fungicides presently being
developed in aid of agriculture. It is probable that there exists
sufficient authority at present to conduct the necessary research
but the fact remains that it is not being conducted.
[p.l]
-------
STATUTES AND LEGISLATIVE HISTORY
703
1.3a (3) CONGRESSIONAL RECORD, VOL. 104 (1958)
1.3a (3) (a) May 29: Passed Senate, pp. 9797-9798
STUDY OF THE EFFECTS OF
INSECTICIDES, HERBICIDES,
AND FUNGICIDES UPON FISH
Mr. MANSFIELD. Mr. President, I
ask unanimous consent that the unfin-
ished business be laid aside temporari-
ly, so that the Senate may proceed to
the consideration of the three matters
to which I have referred. First, I ask
that the Senate proceed to the consid-
eration of Calendar No. 1622, S. 2447.
The PRESIDING OFFICER. The
bill will be stated by title.
The CHIEF CLERK. A bill (S. 2447) to
authorize and direct the Secretary of
the Interior to undertake continuing
studies of the effects of insecticides,
herbicides, and fungicides upon fish
and wildlife for the purpose of prevent-
ing losses of those invaluable natural
resources following spraying and to
provide basic data on the various chem-
ical controls so that forests, croplands,
and marshes can be sprayed with mini-
mum losses of fish and wildlife.
The PRESIDING OFFICER. Is
there objection to the present consider-
ation of the bill?
There being no objection, the Senate
proceeded to consider the bill, which
had been reported from the Committee
on Interstate and Foreign Commerce,
with amendments on page 1, line 5,
after the word "herbicides", to strike
out "and fungicides" and insert "fun-
gicides and pesticides"; on page 2, line
1, after the word "of", to strike out
"determining the amounts and percent-
ages of such chemicals that are lethal
to or injurious to fish and wildlife and
the amounts or percentages or mix-
tures which can be used safely, and
thereby prevent losses of fish and wild-
life from such spraying" and insert
"determining the amounts, percent-
ages, and formulations of such chemi-
cals that are lethal to or injurious to
fish and wildlife and the amounts, per-
centages, mixtures, or formulations
that can be used safely, and thereby
prevent losses of fish and wildlife from
such spraying, dusting, or other treat-
ment."
And, after line 10, to strike out:
SEC. 2. The gum of $280,000 per annum is
hereby authorized to be appropriated to carry
out the objectives of this act.
So as to make the bill read:
Be it enacted, etc.. That the Secretary of the
Interior is authorized and directed to undertake
comprehensive continuing studies on the effects
of insecticides, herbicides, fungicides and pesti-
cides, upon the fish and wildlife resources of
the United States, for the purpose of determin-
ing the amounts, percentages, and formulations
of such chemicals that are lethal to or injurious
to fish and wildlife and the amounts, percent-
ages, mixtures, or formulation that can be
used safely, and thereby prevent losses of fish
and wildlife from such spraying, dusting, or
other treatment.
The amendments were agreed to.
Mr. MAGNUSON. Mr. President,
Senate bill 2447 was unanimously re-
ported by the Committee on Interstate
and Foreign Commerce.
I ask unanimous consent to have
printed in the RECORD at this point ex-
tracts from the report on the bill.
There being no objection, the ex-
tracts from the report (No. 1592) were
ordered to be printed in the RECORD,
as follows:
PURPOSE OP THIS BILL
S. 2447, as amended and approved by unani-
mous vote of your committee, would authorize
and direct the Secretary of the Interior to
undertake continuing studies of the effects of
insecticides, herbicides, fungicides, and pesti-
cides upon fish and wildlife for the purpose of
preventing losses of those invaluable natural
resources following application of these ma-
terials, and to provide basic data on various
chemical controls. This research and study will,
it is anticipated, determine the amounts and
percentages of such formulations and chemicals
that may be used on wet lands, rangelands, and
other lands with a minimum loss to fish and
wildlife.
COMMITTEE ACTION
Public hearings were held by our committee
on this legislation, and everyone desiring to
testify was given an opportunity to be heard.
Appearing and speaking in favor of this legis-
lation were the following: Hon. Lee Metcalf,
-------
704
LEGAL COMPILATION—PESTICIDES
United States Representative from the First
District of Montana ; Lansing A. Parker, As-
sistant Director for Wildlife, Bureau of Sports
[p. 9797]
Fisheries and Wildlife, Department of the In-
terior ; James D. Dewitt, chief chemist. Bureau
of Sports Fisheries and Wildlife, Department of
the Interior; John H. Baker, president. Na-
tional Audubon Society; Charles E. Jackson,
general manager, National Fisheries Institute;
H. S. Mosebrook, forester of the American
Pulpwood Association ; Charles H. Callison, con-
servation director, National Wildlife Federa-
tion ; and Kenneth Pomeroy, representing the
American Forestry Association. This bill is en-
dorsed by farm groups, timber and logging in-
dustries, commercial fisheries, sportsmen, Fed-
eral and State officials.
NEED FOR THIS LEGISLATION
The current situation is, in a large part, due
to the phenomenal growth in the use of new
pesticidal compounds developed since World
War II. The usefulness of these chemicals in
combating ravages of insect pests is evidenced
by reports that over 750 million pounds of
pesticides having a value of over $256 million
are produced in the United States each year.
About two-thirds of this production is for do-
mestic use on some 65 million acres of the
Nation's land and water.
It is reported that there are over 6,000 air-
craft, flying 541,000 hours, used to distribute
or spray around 100 million gallons of liquid
formulations, a major share of which are in-
secticidal.
The effects of these sprays, or dusting, has
not only killed insects, but also destroyed wild
and domestic animals and birds. A Florida
operation to control sandflies resulted in the
death of an estimated 1 million fish of 30 dif-
ferent species. A spray used to destroy tree-
girdling mice has killed other mammals and
birds. In March of 1958 approximately 3,000
geese died from eating treated grain used in
Klamath Basin, Oreg., mouse-control campaign.
Water runoff from some sprays on lands has
killed fish. There is grave concern as to whether
chemicals used to kill ants will even destroy
earthworms, a major source of food for wood-
cock wintering in those areas. In Washington
State, there has been damage to upland birds.
In Montana, on the Yellowstone River, there
was extensive damage to fish following appli-
cation of DDT as part of the spruce budworm
control program. A census of fish in 7 Montana
trout streams showed a loss of from 70 to 80
percent as a result of this spray.
This all points up to a pressing and urgent
need for research studies to provide basic in-
formation which can be used as a guide to the
future development and application of such for-
mulations.
At the present time, the effects of many for-
mulations are not fully known or understood.
Your committee believes this Congress should
set in motion a research program in this all-
important field.
This legislation carries no appropriation with
it.
Mr. CURTIS. Mr. President, will the
Senator from Washington yield?
Mr. MAGNUSON. I yield.
Mr. CURTIS. Does the bill provide
for a new program, or the continua-
tion of a program?
Mr. MAGNUSON. It is a combina-
tion of both. The Agriculture Depart-
ment and the Department of the In-
terior have been somewhat concerned
for many years in their research as to
the effect of insecticides on crops and
on fish and wildlife. The departments
want authority to have a separate
study made in this field.
Mr. CURTIS. Does the bill have the
support of the full committee?
Mr. MAGNUSON. Yes. It was unan-
imously reported.
Mr. CURTIS. How about the De-
partment?
Mr. MAGNUSON. It is a depart-
mental bill. It was introduced at the
request of the Department.
Mr. CURTIS. I thank the Senator.
The PRESIDING OFFICER. The
bill is open to further amendment.
If there be no further amendment to
be offered, the question is on the en-
grossment and third reading of the
bill.
The bill (S. 2447) was ordered to be
engrossed for a third reading, read the
third time, and passed.
The title was amended, so as to read:
"A bill to authorize and direct the Sec-
retary of the Interior to undertake
continuing studies of the effects of in-
secticides, herbicides, fungicides and
other pesticides, upon fish and wildlife
for the purpose of preventing losses of
those invaluable natural resources fol-
lowing application of these materials
and to provide basic data on the vari-
ous chemical controls so that forests,
croplands, wetlands, rangelands and
other lands can be sprayed with mini-
mum losses of fish and wildlife."
[p. 9798]
-------
STATUTES AND LEGISLATIVE HISTORY 705
1.3a (3) (b) July 21: Amended and passed House, p. 14439
[No Relevant Discussion on Pertinent Section]
1.3a (3) (c) July 23: Senate concurs in House amendments, p.
14741
[No Relevant Discussion on Pertinent Section]
1.3b FISH AND WILDLIFE STUDIES
September 16, 1959, P.L. 86-279, 73 Stat. 563
AN ACT
To amend the Act of August 1, 1958, to authorize and direct the Secretary of
the Interior to undertake continuing studies of the effects of insecticides,
herbicides, fungicides, and other pesticides, upon fish and wildlife for the
purpose of preventing losses of those invaluable natural resources, and for
other purposes.
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled, That sec-
tion 2 of the Act of August 1, 1958, providing for continuing
studies of the effects of insecticides, herbicides, fungicides, and
other pesticides, upon fish and wildlife for the purpose of pre-
venting losses of those invaluable natural resources and for other
purposes is amended to read as follows:
"Sec. 2. The sum of $2,565,000 per annum is hereby authorized
to be appropriated to carry out the objectives of this Act."
Approved September 16,1959. r _„„,
Lp.oboJ
1.3b (1) SENATE COMMITTEE ON INTERSTATE AND FOR-
EIGN COMMERCE
S. REP. No. 708, 86th Cong., 1st Sess. (1959)
RESEARCH AND STUDIES ON INSECTICIDES
AUGUST 13 (legislative day, AUGUST 12), 1959.—Ordered to be printed
Mr. MAGNUSON, from the Committee on Interstate and Foreign
Commerce, submitted the following
REPORT
[To accompany S. 1575]
The Committee on Interstate and Foreign Commerce, to which
was referred the bill (S. 1575) to amend the act of August 1, 1958,
to authorize and direct the'Secretary of the Interior to undertake
continuing studies of the effects of insecticides, herbicides, fungi-
cides, and other pesticides, upon fish and wildlife for the purpose
-------
706 LEGAL COMPILATION—PESTICIDES
of preventing losses of those invaluable natural resources, and
for other purposes, having considered the same, report favor-
ably thereon with an amendment and recommend that the bill as
amended do pass.
Public hearings were held by your committee on the amended
bill, and everyone desiring to testify was given an opportunity to
be heard.
PURPOSE OF THE BILL
S. 1575 directs the Secretary of the Interior to continue the
studies inaugurated in 1958, under Public Law 582.
The phenomenal growth in production and use of chemical
control agents is illustrated by the fact that in 1940 these products
had a wholesale value of about $40 million. Today it is $290 million
and is estimated to reach $1 billion by 1975. One-sixth of all the
croplands and millions of acres of forests, rangelands, and marsh-
lands are treated annually with these chemicals. Most of these
areas are important wildlife and fish habitat.
Some of the chemicals persist in the soil for periods of 3 to 5
years and longer. Certain organisms, such as earthworms (angle-
worms), living in treated soils or waters, tend to concentrate the
poison in their body tissue. Hence fishes, crabs, shrimp, and oys-
ters are affected when they feed upon contaminated organisms.
Determination of the effects of pesticidal materials upon impor-
tant forms of animal life is a complex and time-consuming study.
Much greater effort is needed to—
[p. 1]
(1) determine the acute and chronic toxicities of some 200
basic pesticidal chemicals now on the market, plus many others
in various stages of development;
(2) conduct chemical analysis of plant and animal tissue to
determine the presence of pesticide residues, to develop diagnos-
tic procedures for determining suspected poisoning of fishes, birds,
and mammals and for measuring the degree and duration of toxic
conditions in fish and wildlife habitats;
(3) carry out field appraisals of immediate and long range
effects of large scale pest control upon fish and wildlife popula-
tions; and (4) facilitate the compilation and dissemination of
findings from research studies so that chemists, entomologists,
and others may apply such knowledge in the development of new
pest control materials, formulations, and techniques of applica-
tion to minimize hazards to desirable forms of life.
COST
The Secretary of the Interior, June 9, 1959, recommends the
------- OCR error (C:\Conversion\JobRoot\00000CRI\tiff\200152VE.tif): Saving image to "C:\Conversion\JobRoot\00000CRI\tiff\200152VE.T$F.T$F" failed.
-------
708 LEGAL COMPILATION—PESTICIDES
cidal materials employed as fungicides, nematocides, miticides, and rodenti-
cides also require evaluation.
Before 1940, relatively small amounts of such chemicals as nicotine, rote-
none, pyrethrum, and the arsenicals were used for insect control. During and
following World War II a rapid changeover to DDT, heptachlor, dieldrin,
TEPP, malathion, and related compounds occurred. The phenomenal growth in
production and use of chemical control agents is illustrated by the fact that in
1940 these products had a wholesale value of about $40 million, and in 1956
the total reached $290 million. By 1975 it is estimated that the wholesale value
of such materials will reach $1 billion. Approximately one-sixth of all crop-
lands and millions of acres of forests, rangelands, and marshlands are treated
annually with these chemicals. Most of the treated areas constitute important
habitat for numerous forms of fish and wildlife.
Studies to date have shown that DDT may kill fish and other aquatic life
when applied at dosage rates in excess of one-quarter pound per acre; 2
pounds kills birds; and 5 pounds causes heavy mortality to mammals. Other
insecticides such as heptachlor, dieldrin, aldrin, and endrin have acute tox-
icity ranges of from 15 to 200 times that of DDT. Some of these chemicals
persist in the soil for periods of 3 to 5 years or longer. Certain food chain
organisms, such as earthworms, living in treated soils or waters tend to con-
centrate the poisons in their body tissue. Hence, birds like the woodcock and
robin as well as aquatic creatures—fishes, shrimp, crabs, and oysters—are
affected when they feed upon contaminated organisms.
Pheasants, quail, and other species exposed to sublethal amounts of some
pesticides in food materials suffer delayed chronic effects in the form of
reduced reproductive capacity and survival of young. Persistent high levels
of DDT have been found in the bodies of fishes months after temporary con-
centrations in the stream environment had dissipated. Bird numbers in several
of the areas treated with heptachlor for imported fire ant control have been
found to be reduced 75 to 85 percent. Populations of quail, wild turkey, and
rabbits were also decimated or wiped out on some of the areas. In other
parts of the country, particularly the Midwest, local populations of robins
and other insectivorous songbirds have been depleted as a result of measures
carried out for mosquito and Dutch elm disease control.
[p. 3]
Considerable aerial spraying is carried out over salt water marshes, par-
ticularly in the East, and control chemicals applied to land areas adjacent
to inshore water reach important fish-producing water by drainage. There
is thus need to determine the effects of pesticides on inshore aquatic life. Biol-
ogists, fishermen, and conservationists are concerned about the effects of
these chemicals on fish, shrimp, and shellfish which live in inshore water as
adults and on those species for which the marshes and estuaries are essen-
tial nursery grounds. Menhaden, shad, striped bass, croakers, and weakfish
are reared in these areas during their early stages. Shrimp, crabs, oysters,
and clams which support major commercial fisheries, spend a part or all of
their lives in inshore environments.
Although the potential dangers from expanding use of insecticides is con-
sidered one of the most serious threats to valuable commercial fisheries today,
no comprehensive program for related research has yet been activated. The
limited work to date is incidental to other activities for which funds have been
provided. Findings from studies carried out at the Galveston Laboratory
-------
STATUTES AND LEGISLATIVE HISTORY 709
show that lindane, an insecticide employed for the control of mosquitoes, is
very toxic to shrimp. A total kill of laboratory test animals resulted within
24 hours after exposure to concentrations of the chemical as low as five parts
per billion. Other findings reveal that crabs may be killed by eating fish flesh
containing low levels of malathion.
Determination of the effects of pesticidal materials upon important forms of
animal life is a complex and time-consuming study. Much greater effort is
needed to: (1) Determine the acute and chronic toxicities of some 200 basic
pesticidal chemicals now on the market, plus many others in various stages
of development; (2) conduct chemical analysis of plant and animal tissue to
determine the presence of pesticide residues, to develop diagnostic pro-
cedures for determining suspected poisoning of fishes, birds, and mammals
and for measuring the degree and duration of toxic conditions in fish and
wildlife habitats; (3) carry out field appraisals of immediate and long-range
effects of large-scale pest control operations upon fish and wildlife popula-
tions; and (4) facilitate the compilation and dissemination of findings from
research studies so that chemists, entomologists, and others may apply such
knowledge in the development of new pest control materials, formulations,
and techniques of application to minimize hazards to desirable forms of life.
As required by the act of July 25, 1956 (70 Stat. 652), the attached addi-
tional information has been prepared concerning the estimated additional
man-years of civilian employment and expenditures for the first 5 years of
the program to which this legislation relates.
We have been advised by the Bureau of the Budget that there is no objection
to the submission of this report to your committee. Such advice, we are
informed by that Bureau, should not be construed as reflecting any commit-
ment as to the necessity for any appropriations beyond those contained in the
1960 budget for pesticide research.
Sincerely yours,
Ross LEFFLER,
Assistant Secretary of the Interior.
[p. 4]
CHANGES IN EXISTING LAW
In compliance with subsection (4) of rule XXIX of the Stand-
ing Rules of the Senate, changes in existing law made by the bill,
as reported, are shown as follows (new matter is printed in italic,
existing law in which no change is proposed is shown in roman,
matter which is omitted is shown in brackets).
PUBLIC LAW 85-582,85TH CONGRESS (72 STAT. 479)
AN ACT To authorize and direct the Secretary of the Interior to undertake
continuing studies of the effects of insecticides, herbicides, fungicides and
other pesticides, upon fish and wildlife for the purpose of preventing losses
of those invaluable natural resources following application of these mate-
rials and to provide basic data on the various chemical controls so that
forests, croplands, wetlands, rangelands and other lands can be sprayed
with minimum losses of fish and wildlife.
That the Secretary of the Interior is authorized and directed
to undertake comprehensive continuing studies on the effects of
-------
710 LEGAL COMPILATION—PESTICIDES
insecticides, herbicides, fungicides and pesticides, upon the fish
and wildlife resources of the United States, for the purpose of
determining the amounts, percentages, and formulations of such
chemicals that are lethal to or injurious to fish and wildlife and
the amounts, percentages, mixtures, or formulations that can be
used safely, and thereby prevent losses of fish and wildlife from
such spraying, dusting, or other treatment.
"Sec. 2 [The sum of $280,00.0 per annum is hereby authorized
to be appropriated to carry out the objectives of this Act.] There
is hereby authorized to be appropriated such sums as are neces-
sary to carry out the purposes of this Act."
[p. 5]
1.3b (2) HOUSE COMMITTEE ON MERCHANT MARINE AND
FISHERIES
H.R. REP. No. 975, 86th Cong., 1st Sess. (1959)
AUTHORIZING AND DIRECTING THE SECRETARY OF
THE INTERIOR TO UNDERTAKE CONTINUING STUDIES
OF THE EFFECTS OF INSECTICIDES, HERBICIDES,
FUNGICIDES, AND OTHER PESTICIDES UPON
FISH AND WILDLIFE
AUGUST 24,1959.—Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
Mr. BONNER, from the Committee on Merchant Marine and
Fisheries, submitted the following
REPORT
[To accompany H.R. 5813]
The Committee on Merchant Marine and Fisheries, to whom
was referred the bill (H.R. 5813) to amend the act of August 1,
1958, to authorize and direct the Secretary of the Interior to
undertake continuing studies of the effects of insecticides, herbi-
cides, fungicides, and other pesticides, upon fish and wildlife for
the purpose of preventing losses of those invaluable natural
resources, and for other purposes, having considered the same,
report favorably thereon without amendment and recommend
that the bill do pass.
PURPOSE OP THE BILL
The purpose of the bill is to increase substantially the author-
ized appropriation contained in the bill reported by this commit-
tee and enacted into law during the 85th Congress (Public Law
-------
STATUTES AND LEGISLATIVE HISTORY 711
85-582). That bill authorized the appropriation of $280,000 annu-
ally to study the effects of insecticides, herbicides, fungicides, and
other pesticides on fish and wildlife. At the time of the enact-
ment of that bill the committee was informed that the specified
amount of $280,000 was sufficient to institute such a program
but that as it developed there probably would be a need for addi-
tional funds. Since the enactment of that legislation it has come
to the attention of the committee that adverse effects upon wild-
life of the insecticide programs being carried on, particularly by
the Department of Agriculture, have proven much greater than
anticipated. Many wildlife species are in imminent danger of
destruction while successful efforts have been made to reduce the
amount of insecticides being used in such programs, such as that
[p.l]
of the fire ant eradication, there is reason to believe that even so
the wildlife in the affected areas continues to be in danger of era-
dication.
The committee notes that the authorization contained in the bill
for the expenditure of $2,565,000 is relatively small in comparison
with the insecticide programs presently in operation.
The Department of the Interior recommends the enactment of
the bill but suggests the elimination of the appropriation authori-
zation limitation. It believes that an arbitrary appropriation limi-
tation on an important research program may prove to be inac-
curate and unrealistic if the basic objectives of the program are to
be realized. However, the committee is of the view that the ceiling
contained in the bill is a desirable one and that if the expenditure
of larger amounts becomes necessary as the program develops, it
would be in order for the Fish and Wildlife Service to request
additional authorization as needed.
The reports of the Department of the Interior and the Depart-
ment of Agriculture follow:
DEPARTMENT OF THE INTERIOR,
OFFICE OF THE SECRETARY,
Washington, D.C., June 9,1959.
HON. HERBERT C. BONNER,
Chairman, Committee on Merchant Marine and Fisheries,
House of Representatives, Washington, D.C.
DEAR MR. BONNER: Your committee has requested a report on H.R. 5813,
a bill to amend the act of August 1, 1958, to authorize and direct the Secre-
tary of the Interior to undertake continuing: studies of the effects of insecti-
cides, herbicides, fungicides, and other pesticides, upon fish and wildlife for
the purpose of preventing losses of those invaluable natural resources, and
for other purposes. This bill would amend the 1958 act for the purpose of
authorizing increased appropriations to carry out the studies specified by that
-------
712 LEGAL COMPILATION—PESTICIDES
act. The act now authorizes the appropriation of $280,000 annually. By the
terms of this bill, annual appropriations of $2,565,000 would be authorized.
We recommend the enactment of this proposal if amended to eliminate the
present appropriation authorization contained in the 1958 act.
We believe that no specific appropriation authorization should be pres-
cribed in the act. As this research program develops and expands on a logi-
cal scientific basis, funds can be requested, as required by circumstances, in
accordance with established budgetary procedures. Consequently, we believe
that an arbitrary appropriation limitation on an important research pro-
gram may prove to be inaccurate and unrealistic if the basic objectives of the
program are to be realized. In any event, it is clear from our initial studies
that because of the magnitude of the problem to which this legislation is
directed, and the scope of the research that will be required, the present appro-
priation authorization is inadequate.
As directed by the 1958 act, we have begun research concerning the effects
of insecticides, herbicides, fungicides, and other pesticides upon fish and wild-
life for the purpose of preventing losses of these natural resources. As this
program of study gets underway, it is becoming clear that to understand
adequately and to reduce the detrimental effects of diverse and extensive pest
control activities upon fish and wildlife resources will require a continuing
research effort of much greater magnitude than is currently authorized. Man-
[p. 2]
power and facilities afforded by the present program permit only limited
study of a very small percentage of the wide array of recently developed insec-
ticides and herbicides in relation to a few forms of animal life. Numerous
new pesticidal materials employed as fungicides, nematocides, miticides, and
rodenticides also require evaluation.
Before 1940, relatively small amounts of such chemicals as nicotine, rote-
none, pyrethrum, and the arsenicals were used for insect control. During and
following World War II a rapid changeover to DDT, heptachlor, dieldrin,
TEPP, malathion, and related compounds occurred. The phenomenal growth
in production and use of chemical control agents is illustrated by the fact that
in 1940 these products had a wholesale value of about $40 million, and in 1956
the total reached $290 million. By 1975 it is estimated that the wholesale value
of such materials will reach $1 billion. Approximately one-sixth of all crop-
lands and millions of acres of forests, rangelands, and marshlands are treat-
ed annually with these chemicals. Most of the treated areas constitute impor-
tant habitat for numerous forms of fish and wildlife.
Studies to date have shown that DDT may kill fish and othe aquatic life
when applied at dosage rates in excess of one-quarter pound per acre; 2
pounds kills birds; and 5 pounds causes heavy mortality to mammals. Other
insecticides such as heptachlor, dieldrin, aldrin, and endrin have acute toxicity
ranges of from 15 to 200 times that of DDT. Some of these chemical persist in
the soil for periods of 3 to 5 years of longer. Certain food chain organisms,
such as earthworms, living in treated soils or waters tend to concentrate the
poisons in their body tissue. Hence, birds like the woodcock and robin as well
as aquatic creates—fishes, shrimp, crabs, and oysters—are affected when they
feed upon contaminated organisms.
Pheasants, quail, and other species exposed to sublethal amounts of some
pesticides in food materials suffer delayed chronic effects in the form of reduced
reproductive capacity and survival of young. Persistent high levels of
-------
STATUTES AND LEGISLATIVE HISTORY 713
DDT have been found in the bodies of fishes months after temporary concen-
trations in the stream environment had dissipated. Bird numbers in several
of the areas treated with heptachlor for imported fire ant control have been
found to be reduced 75 to 85 percent. Populations of quail, wild turkey, and
rabbits were also decimated or wiped out on some of the areas. In other parts
of the country, particularly the Midwest, local populations of robins and
other insectivorous songbirds have been depleted as a result of measures car-
ried out for mosquito and Dutch elm disease control.
Considerable aerial spraying is carried out over salt water marshes, par-
ticularly in the East, and control chemicals applied to land areas adjacent
to inshore water reach important fish-producing water by drainage. There
is thus need to determine the effects of pesticides on inshore aquatic life. Bio-
logists, fishermen, and conservationists are concerned about the effects of these
chemicals on fish, shrimp, and shellfish which live in inshore water as adults
and on those species for which the marshes and estuaries are essential nur-
sery grounds. Menhaden, shad, striped bass, croakers, and weakfish are reared
in these areas during their early stages. Shrimp, crabs, oysters, and clams,
which support major commercial fisheries, spend a part or all of their lives
in inshore environments.
[p. 3]
Although the potential dangers from expanding use of insecticides is con-
sidered one of the most serious threats to valuable commercial fisheries today,
no comprehensive program for related research has yet been activated. The
limited work to date is incidental to other activities for which funds have been
provided. Findings from studies carried out at the Galveston Laboratory show
that lindane, an insecticide employed for the control of mosquitoes, is very
toxic to shrimp. A total kill of laboratory test animals resulted within 24 hours
after exposure to concentrations of the chemical as low as five parts per
billion. Other findings reveal that crabs may be killed by eating fish flesh con-
taining low levels of malathion.
Determination of the effects of pesticidal materials upon important forms
of animal life is a complex and time-consuming study. Much greater effort is
needed to (1) determine the acute and chronic toxicities of some 200 basic
pesticidal chemicals now on the market, plus many others in various stages of
development; (2) conduct chemical analysis of plant and animal tissue to
determine the presence of pesticide residues, to develop diagnostic procedures
for determining suspected poisoning of fishes, birds, and mammals and for
measuring the degree and duration of toxic conditions in fish and wildlife
habitats; (3) carry out field appraisals of immediate and long-range effects of
large-scale pest control operations upon fish and wildlife populations; and (4)
facilitate the compilation and dissemination of findings from research studies
so that chemists, entomologists, and others may apply such knowledge in the
development of new pest control materials, formulations, and techniques of
application to minimize hazards to desirable forms of life.
As required by the act of July 25, 1956 (70 Stat. 652), the attached addi-
tional information has been prepared concerning the estimated additional
man-years of civilian employment and expenditures for the first 5 years of
the program to which this legislation relates.
We have been advised by the Bureau of the Budget that there is no objec-
tion to the submission of this report to your committee. Such advice, we are
informed by that Bureau, should not be construed as reflecting any commit-
-------
714 LEGAL COMPILATION—PESTICIDES
ment as to the necessity for any appropriations beyond those contained in the
1960 budget for pesticide research.
Sincerely yours,
(Signed) Ross LEFFLER,
Assistant Secretary of the Interior.
[p. 4]
Estimated additional man-years of civilian employment and expenditures for 5-year
program (preliminary)
19CY1 19CY+1 19CY+2
Executive direction:
Executive
Clerical . .
Stenographic
Total executive. _
Administrative service
and support
Program:
Laboratory and field
Supporting
Total program
Total estimated
additional man-years .
0
0
0
0
0
2
2
4
4
2
1
2
5
0
21
13
34
39
2
2
2
6
0
36
27
63
69
19CY+3 19CY+4
2
2
2
6
0
50
44
94
100
2
6
0
64
61
125
131
Estimated additional
expenditures:
Personal services $180,000 $505,000 $780,000 $1,055,000 $1,330,000
Expenses2 100,000 275,000 500,000 725,000 950,000
Total estimated
additional
expenditures 280,000 780,000 1,280,000 1,780,000 2,280,000
Total costs:
1st year $280,000
2d to 5th years 6,120,000
5 years 6,400,000
1 CY—current year (fiscal year 1960).
2 Includes $50,000 for contract services beginning CY-f 2.
DEPARTMENT OF AGRICULTURE,
Washington, D.C., June U, 1959.
Hon. HERBERT C. BONNER,
Chairman, Committee on Merchant Marine and Fisheries,
House of Representatives.
DEAR CONGRESSMAN BONNER: This is in reply to your request of March 25,
1959, for a report on H.R. 5813, a bill to amend the act of August 1, 1958, to
authorize and direct the Secretary of the Interior to undertake continuing
studies of the effects of insecticides, herbicides, fungicides, and other pesti-
cides, upon fish and wildlife for the purpose of preventing losses of those
invaluable natural resources, and for other purposes.
-------
STATUTES AND LEGISLATIVE HISTORY 715
Since the bill covers work that would be performed by the Department of
the Interior, we have no recommendation to make regarding its enactment.
The Bureau of the Budget advises that there is no objection to the sub-
mission of this report.
Sincerely yours,
TRUE D. MORSE, Acting Secretary.
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
italic, existing law in which no change is proposed is shown in
roman):
Public Law 85-582
85th Congress, S. 2447
August 1,1958
AN ACT To authorize and direct the Secretary of the Interior to undertake
continuing studies of the effects of insecticides, herbicides, fungicides and
other pesticides, upon fish and wildlife for the purpose of preventing losses
of those invaluable natural resources following application of these mate-
rials and to provide basic data on the various chemical controls so that
forests, croplands, wetlands, rangelands and other lands can be sprayed
with .ninimum losses of fish and wildlife.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, That the Secre-
tary of the Interior is authorized and directed to undertake com-
prehensive continuing studies on the effects of insecticides, herbi-
cides, fungicides and pesticides, upon the fish and wildlife resources
of the United States, for the purpose of determining the amounts
percentages, and formulations of such chemicals that are lethal to
or injurious to fish and wildlife and the amounts, percentages, mix-
tures, or formulations that can be used safely, and thereby prevent
losses of fish and wildlife from such spraying, dusting, or other
treatment.
[SBC. 2. The sum of $280,000 per annum is hereby authorized to
be appropriated to carry out the objectives of this Act.]
Sec. 2. The sum of $2,565,000 per annum is hereby authorized to
be appropriated to carry out the objectives of this Act.
[p. 6]
1.3b (3) CONGRESSIONAL RECORD, VOL. 105 (1959)
1.3b (3) (a) Aug. 19: Amended and passed Senate, p. 16345
[No Relevant Discussion on Pertinent Section]
-------
716
LEGAL COMPILATION—PESTICIDES
1.3b (3) (b) Sept. 2: Amended and passed House, pp. 17768-
17769
[No Relevant Discussion on Pertinent Section]
1.3b (3) (c)
18938
Sept. 10: Senate concurs in House amendments, p.
STUDIES OF THE EFFECTS OF
CERTAIN INSECTICIDES UPON
FISH AND WILDLIFE
*****
Mr. MAGNUSON. Mr. President,
the bill authorized the appropriation
of such sums as might be necessary to
carry out the purposes of the act, which
authorized and directed the Secretary
of the Interior to undertake continu-
ing studies of the effects of insecticides,
herbicides, fungicides, and other pes-
ticides, upon fish and wildlife for the
purpose of preventing losses of those
invaluable natural resources. The
House amended the bill by placing a
limit on the authorization.
Mr. President, I move that the Sen-
ate concur in the House amendment.
The PRESIDING OFFICER. The
question is on agreeing to the motion
of the Senator from Washington.
The motion was agreed to.
[p. 18938]
1.3c PROTECTION OF FISH AND WILDLIFE FROM
PESTICIDES
October 1, 1965, P.L. 89-232, 79 Stat. 902
AN ACT
To amend the Act of August 1, 1958, relating to a continuing study by the
Secretary of the Interior of the effects of insecticides, herbicides, fungicides,
and other pesticides upon fish and wildlife for the purpose of preventing los-
ses to this resource.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, That section 2 of
the Act of August 1,1958 (72 Stat. 479), as amended by the Act of
September 16,1959 (73 Stat. 563), is amended to read as follows:
"SEC. 2. In order to carry out the provisions of this Act, there
are authorized to be appropriated for the fiscal year ending June
30,1966, not to exceed $3,200,000, and not to exceed $5,000,000 for
each of the two fiscal years immediately following such year."
Approved October 1,1965.
[p. 902]
-------
STATUTES AND LEGISLATIVE HISTORY 717
1.3c (1) SENATE COMMITTEE ON COMMERCE
S. REP. No. 169, 89th Cong., 1st Sess. (1965)
PROTECTION OF FISH AND WILDLIFE FROM PESTICIDES
APRIL 28,1965.—Ordered to be printed
Mr. MAGNUSON, from the Committee on Commerce, submitted the
following
REPORT
[To accompany S. 1623]
The Committee on Commerce, to whom was referred the bill
(S. 1623) to amend the act of August 1, 1958, relating to a continu-
ing study by the Secretary of the Interior of the effects of insecti-
cides, herbicides, fungicides, and other pesticides upon fish and
wildlife for the purpose of preventing losses to this resource,
having considered the same, report favorably thereon with an
amendment and recommend that the bill as amended do pass.
PURPOSE OF THE BILL
The purpose of the bill, as amended, is to increase the authorized
annual appropriation for pesticide research by the Department of
the Interior from $2,565,000 to $3.2 million for fiscal year 1966 and
$5 million annually for fiscal years 1967 and 1968.
BACKGROUND
On May 15, 1963, the President's Science Advisory Committee
issued its report on the "Use of Pesticides." The Committee cited
the compelling need for participation by the Interior Department
in the establishment of a "continuing network to monitor residue
levels in air, water, soil, man, wildlife, and fish." This Committee
similarly urged "expanded research and evaluation by the Depart-
ment of the Interior of the toxic effects of pesticides on wild verte-
brates and invertebrates."
"The study of wildlife," the President's Committee concluded,
"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 acccmulated and, in some cases, magnified
[p.l]
pesticide residues can find their way directly or indirectly to wild-
life and to man."
During the last Congress, the Commerce Committee held hear-
ings on legislation to eliminate the present $2,565,000 authorization
ceiling on pesticide research by the Department of the Interior.
-------
718 LEGAL COMPILATION—PESTICIDES
Among the witnesses who appeared before the committee was
Rachel Carson, the famed biologist, whose "Silent Spring" alerted
millions of Americans to the potential danger from the uncon-
trolled use of pesticides.
The committee reported and the Senate passed, unanimously
S. 1251, which would have authorized the appropriation of $3.2
million for fiscal year 1965 and $5 million annually thereafter.
Senate action came too late in the session to enable the measure to
go to conference with the House for the resolution of differing
provisions between the Senate and House versions.
In his message to Congress on natural beauty early this year,
President Johnson dealt with the limitation on pesticide research:
Pesticides may effect living organisms wherever they occur.
In order that we may better understand the effects of those
compounds, I have included increased funds in the budget for
use by the Secretaries of Agriculture, Interior, and Health,
Education, and Welfare to increase their research efforts on
pesticides through the environment; study the means by
which pesticides break down and disappear in nature; and to
keep a constant check on the level of pesticides in our water,
air, soil, and food supply.
I have asked the Secretary of the Interior to submit legis-
lation to eliminate the ceiling on pesticide research.
COMMITTEE CONSIDERATION OF THE BILL
S. 1623, to eliminate the ceiling, was introduced by the chairman
and Mrs. Neuberger at the request of the Secretary of the Interior.
The committee was of the opinion that a ceiling should be placed on
the authorized appropriations for pesticide research in line with
the current needs for such research and that Congress should have
an opportunity to review these needs again in 3 years. The com-
mittee was informed by the Department of the Interior that a ceil-
ing of $3.2 million for fiscal year 1966 and $5 million annually
thereafter would be adequate to support the necessary forseeable
expansion in the Department. Therefore, the committee recom-
mends the adoption of an amendment increasing the authorization
for pesticide research for $3.2 million for fiscal 1966 and $5 million
annually for fiscal years 1967 and 1968.
[p. 2]
-------
STATUTES AND LEGISLATIVE HISTORY 719
1.3c (2) HOUSE COMMITTEE ON MERCHANT MARINE AND
FISHERIES
H.R. REP. No. 1002, 89th Cong., 1st Sess. (1965)
PROTECTION OF FISH AND WILDLIFE FROM PESTICIDES
SEPTEMBER 14,1965.—Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
Mr. GARMATZ, from the Committee on Merchant Marine and
Fisheries, submitted the following
REPORT
[To accompany S. 1623]
The Committee on Merchant Marine and Fisheries, to whom was
referred the bill (S. 1623) to amend the act of August 1, 1958,
relating to a continuing study by the Secretary of the Interior of
the effects of insecticides, herbicides, fungicides, and other pesti-
cides upon fish and wildlife for the purpose of preventing losses to
this resource, having considered the same report favorably thereon
without amendment, and recommend that the bill do pass.
PURPOSE OF THE BILL
The purpose of the bill is to increase the ceiling on authorized
annual appropriations for pesticide research from $2,565,000 to
$3.2 million for fiscal year 1966 and to $5 million annually for fiscal
years 1967 and 1968.
[p.l]
NEED FOR THE LEGISLATION
Your committee feels that an excellent explanation for the need
of this legislation can be found in the statement of Dr. Stanley A.
Cain, Assistant Secretary of the Interior for Fish and Wildlife,
presented at the open hearings on June 22, 1965, before the Sub-
committee on Fisheries and Wildlife Conservation, on S. 1623 and
related bills. Excerpts from that statement are as follows:
The Fish and Wildlife Service has studied the effects of
chemical pesticides, particularly DDT, on fish and wildlife
for more than 20 years. After receiving specific authorization
and appropriations, the Service has broadened its studies to
cover other chemicals and other species of animals.
Interior is a user of pesticides in many of its programs, and
is not opposed to their use, because we know the benefits that
these chemicals can bring. At the same time, through our back-
ground of studies of * * *, we know that some pesticides pose
-------
720 LEGAL COMPILATION—PESTICIDES
serious hazards and must be used with extreme caution against
proper targets.
Research to date has demonstrated some really disturbing
facts about minute quantities of pesticide chemicals used in
improper manner and reaching unexpected environments.
*******
DDT concentrations of one part per billion will kill blue
crabs in coastal estuaries within 8 days. Commercially im-
[p. 2]
portant brown and pink shrimp exposed to less than 0.5 part
per billion of another chemical were paralyzed in 48 hours,
and presumably would have died had they been in their natural
environments.
Oysters exposed to DDT at 0.5 part per million in small
tanks removed over half of the pesticides from the water
within 6 hours and concentrated it in their bodies * * *.
The Department of the Interior is deeply concerned about
the ways in which pesticides turn up in unlikely places. We
have found them in penguins and seals in Antarctica as well
as in animals in the far north, far removed from any local
spray programs.
They are found in the wild game taken by sportsmen. Com-
mercial fishermen have no control over the ways in which
pesticides may reach and be stored in the flesh of their prod-
uct. Although our past research has given us much informa-
tion, we believe that much more should be obtained to prevent
the decimation of fish and wildlife populations and the con-
tamination of their environments.
For example, we hope to monitor the occurrence of pesti-
cide residues in commercial fish and shellfish in their natural
environments, in recreationally important fish species, and
in wild birds and mammals * * *.
Much of the Department of the Interior's pesticide research
programs must be extended to studying the long-term effects
on fish and wildlife populations * * *.
Residues accumulated in fish and wildlife as they consume
other animals are greatly magnified to the point where acute
poisoning and tissue damage ultimately result. We know
almost nothing about the biological and toxicological signifi-
cance of continued exposure to small quantities of these chem-
icals either in animals or in man.
Neither do we know what happens when these chemicals
are mixed in small quantities over long periods of time * * *.
-------
STATUTES AND LEGISLATIVE HISTORY 721
We like to believe that the Department of the Interior is
on the right track in its current research on the ecological
implications of pesticides to animals, particularly fish and
game, and indirectly to man himself.
* * * For these reasons, we feel that the current ceilings
are too low. We also repeat the suggestion that no ceiling be
imposed, relying instead upon the annual review of congres-
sional appropriations committees to evaluate our progress and
our use of these very important funds for pesticide research.
Your committee noted that on May 15, 1963, the President's
Science Advisory Committee issued its report on the "Use of Pesti-
cides," wherein it recommended—
expanded research and evaluation by the Department of the
Interior of the toxic effects of pesticides on wild vertebrates
and invertebrates.
Your committee further noted that the witnesses from the De-
partments of Interior and Agriculture, in their support of the leg-
islation, stated that the President in his message to the Congress
[p. 3]
on natural beauty, of February' 8, 1965, pointed to the need for in-
creased research on pesticides and recommended the removal of
the ceiling on such research. Further, the witnesses stated that
consistent with the President's request, legislation was introduced
in the Senate which would eliminate the ceiling on pesticide re-
search and authorize such sums as may be necessary to carry out
the purposes of the act (S. 1623 as originally introduced).
Your committee was advised by the witness from the Interior
Department that the maximum amount authorized to be appropri-
ated under the act of August 1, 1958, $2,565,000, had been appro-
priated for fiscal year 1965, and that the Department of the In-
terior's planned program for that year called for expenditures of
about $3.5 million. It was further explained that because of the
increased need for expanded pesticide research, projected plans
call for the expenditure of approximately $5 million for the next
fiscal year and $7 million each year thereafter. In view of the fore-
going, your committee is of the opinion that a ceiling should be
placed on the authorized appropriation approximating the current
needs. Therefore, your committee unanimously recommends the
adoption of S. 1623, which would increase the authorization for
pesticide research to $3.2 million for fiscal 1966, and $5 million
annually for fiscal years 1967 and 1968.
It was the thinking of your committee that this legislation should
be limited to a period of 3 years so that at the termination of the
-------
722
LEGAL COMPILATION—PESTICIDES
program the Congress would have an opportunity again to review
the needs for pesticide research.
COST OP THE LEGISLATION
The cost of this legislation authorized by S. 1623 for fiscal year
1966 is $3.2 million and $5 million annually for fiscal years 1967
and 1968.
DEPARTMENTAL REPORTS
Departmental reports received on the bill are as follows:
[p. 4]
1.3c (3) CONGRESSIONAL RECORD, VOL. Ill (1965)
1.3c (3) (a) April 29: Amended and passed Senate, pp. 8967-8968
[No Relevant Discussion on Pertinent Section]
1.3c (3) (b) Sept. 20: Passed House, p. 24374
PROTECTION OF FISH AND
WILDLIFE FROM PESTICIDES
Mr. DINGELL. Mr. Speaker, I move
to suspend the rules and pass the bill
(S. 1623) to amend the act of August 1,
1958, relating to a continuing study
by the Secretary of the Interior of the
effects of insecticides, herbicides, fun-
gicides, and other pesticides upon fish
and wildlife for the purpose of pre-
venting losses to this resource.
The Clerk read as follows:
Be it enacted by the Senate and House of
Representatives of the United States of Amer-
ica in Congress assembled. That section 2 of
the Act of August 1, 1968 (72 Stat. 479). as
amended by the Act of September 16, 1969
(73 Stat. 563), is amended to read as follows:
"SEC. 2. In order to carry out the provisions
of this Act, there are authorized to be appro-
priated for the fiscal year ending June 30, 1966,
not to exceed $3,200,000, and not to exceed
$5,000,000 for each of the two fiscal years im-
mediately following such year."
The SPEAKER. Is a second de-
manded?
Mr. PELLY. Mr. Speaker, I demand
a second.
The SPEAKER. Without objection,
a second will be considered as ordered.
There was no objection.
Mr. DINGELL. Mr. Speaker, this is
an important piece of legislation. It
has been endorsed unanimously by ev-
ery Federal agency that has reported
upon it. It has the support of all the
private conservation agencies and the
State game and fish conservation com-
missions across the country.
This piece of legislation imposes a
3-year limitation on what otherwise
was a program that was open-ended
insofar as time is concerned. It raises
the existing amount of money author-
ized for research into the effects of
pesticides on fish and wildlife from
$2,565,000 to $3,200,000 for the first
year, and then to $5 million for each
of the next 2 years.
It is a piece of legislation which has
an important place in conservation and
is one of the pieces of legislation which
President Johnson mentioned in one of
his messages to the Congress.
Mr. PELLY. Mr. Speaker, I yield
myself 1 minute.
Mr. Speaker, S. 1623 would increase
the ceiling on authorized annual appro-
priations for pesticide research from
$2,565,000 to $3,200,000 annually for
fiscal years 1967 and 1968.
I think the hearings adequately jus-
tified the need for this increase. Al-
ready, research has indicated some
-------
STATUTES AND LEGISLATIVE HISTORY
723
frightening facts as to the danger to
wildlife by minute quantities of chem-
icals which find their way into and
pollute our streams and other waters.
I support this legislation which was
approved unanimously by the House
Subcommittee on Fish and Wildlife.
I urge its adoption.
Mr. SCHMIDHAUSER. Mr. Speak-
er, I rise in support of S. 1623, a bill
designed to afford greater protection
for fish and wildlife from pesticides.
There is no program more closely re-
lated to the long-range conservation
objectives of our Nation than this mea-
sure. All of the great programs which
have been enacted in Congress during
this session, and this most assuredly
has been a "conservation" Congress,
would have little effect if our Nation's
fish and wildlife were silently de-
stroyed because we do not fully under-
stand the lethal effects of chemicals
which are designed to control pests.
This is why it is especially important
that the authority of the Secretary of
Interior to authorize scientific study
of the effects of pesticides and other
poisonous chemicals upon our Nation's
fish and wildlife be continued and ex-
panded.
I therefore urge passage of this
much-needed legislation.
The SPEAKER. The question is,
Will the House suspend the rules and
pass the bill, S. 1623?
The question was taken; and (two-
thirds having voted in favor thereof)
the rules were suspended and the bill
was passed.
A motion to reconsider was laid on
the table.
1.3d PESTICIDE RESEARCH
July 11,1968, P.L. 90-394, 83 Stat. 338
AN ACT
To amend section 2 of the Act of August 1,1958, as amended, in order to pre-
vent or minimize injury to fish and wildlife from the use of insecticides,
herbicides, fungicides, and other pesticides.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, That section 2 of
the Act of August 1, 1958 (72 Stat. 479), as amended (16 U.S.C.
742d-l note), is amended to read as follows:
"SEC. 2. In order to carry out the provisions of this Act, there is
authorized to be appropriated the sum of $3,500,000 for the fiscal
year ending June 30, 1969, and for each of the two fiscal years
immediately following such year. Such sums shall remain available
until expended."
Approved July 11,1968.
[p. 338]
-------
724 LEGAL COMPILATION—PESTICIDES
1.3d (1) HOUSE COMMITTEE ON MERCHANT MARINE AND
FISHERIES
H.R. REP. No. 1223, 90th Cong., 2d Sess. (1968)
PESTICIDE RESEARCH
MARCH 29,1968.—Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
Mr. GARMATZ, from the Committee on Merchant Marine and
Fisheries submitted the following
REPORT
[To accompany H.R. 15979]
The Committee on Merchant Marine and Fisheries to whom
was referred the bill (H.R. 15979), to amend the act of August 1,
1958, in order to prevent or minimize injury to fish and wildlife
from the use of insecticides, herbicides, fungicides, and pesticides,
and for other purposes, having considered the same, report favor-
ably thereon with amendments and recommend that the bill do pass.
The amendments are as follows:
On page 3, line 7, strike out "June 30, 1968,", and insert in lieu
thereof the following: "June 30,1969,".
On page 3, line 8, strike out "succeeding fiscal year.' ", and insert
in lieu thereof the following: "of the two fiscal years immediately
following such year.' ".
PURPOSE OF THE BILL
The purpose of the bill is to prevent or minimize injury to fish
and wildlife from the use of insecticides, fungicides, pesticides, and
other poisonous chemicals.
LEGISLATIVE BACKGROUND
The bill was introduced March 14, 1968, by Congressman Jo-
seph E. Karth. It is identical to a bill previously introduced on
January 10,1967, by Congressman John D. Dingell.
The Subcommittee on Fisheries and Wildlife Conservation held
hearings on the legislation on March 14,1968.
The Department of Agriculture, in its report on the legislation,
indicated that it had no objection to the bill to the extent it would
[p.l]
provide new and more extensive research data on the relation of
pesticides to fish and wildlife. However, it deferred to the Depart-
ment of the Interior as to the need for this provision. The Depart-
ment of Agriculture opposed the labeling provision in the bill—
-------
STATUTES AND LEGISLATIVE HISTORY 725
section l(b)—on the grounds that it would create a conflict of
authority between the Secretaries of the Interior and Agriculture
in the administration of the Federal Insecticide, Fungicide, and
Rodenticide Act. Also, the objective of this provision is the subject
of a 1964 interdepartmental agreement and is being carried out
administratively among the Departments of the Interior, Agri-
culture, and Health, Education, and Welfare.
The Department of Health, Education, and Welfare reported
that—
We are in accord with the objectives of this bill. * * * We
believe, however, that section 1 of the bill in regard to labeling
is unnecessary * * * This interdepartmental agreement is
intended to provide a mechanism for the efficient coordination
of matters relating to pesticides which section 1 of H.R. 487
undertakes to remedy * * *
We defer to the views of the Department of the Interior
with respect to section 2 of the bill.
The Department of the Interior strongly recommended enact-
ment of the legislation with certain amendments. It recommended
that subsection (b) of section 1 be deleted as the objective of this
subsection is the subject of the 1964 administrative agreement. It
recommended that section 2 of the bill be deleted as the Department
has ample authority under the Fish and Wildlife Act of 1956 and
the Federal Water Pollution Control Act to carry out all that would
be authorized by this section.
The Department did not deem legislation necessary in any way
except to extend the research program beyond June 30, 1968.
Accordingly, the Department suggested a draft bill which would
extend the 1958 act authorization indefinitely. In addition, it would
remove the dollar ceiling, as recommended by the President in the
89th Congress.
Although all agencies reporting on the legislation expressed
opposition to the labeling provision of the bill, none expressed
opposition to the objectives of the legislation, and all witnesses
testifying at the hearings were in support of extending the pesti-
cide research program. After giving careful consideration to all the
evidence presented at the hearings and the departmental reports,
your committee reported the bill as introduced except for the sec-
tion pertaining to the authorization of funds. Your committee
amended this section to limit the program to a period of 3 years
only.
BACKGROUND AND NEED FOR THE LEGISLATION
Your committee feels that an excellent explanation for the need
-------
726 LEGAL COMPILATION—PESTICIDES
of this legislation can be found in a 1966 publication issued by the
Fish and Wildlife Service, U.S. Department of the Interior, entitled
"Fish, Wildlife, and * * * Pesticides." Excerpts from that publica-
tion are as follows:
Today, in the United States, 8,000 manufacturing firms mix
about 500 chemical compounds into more than 60,000 formula-
tions registered for use as pesticides. In 1964, the U.S. chemi-
[P.2]
cal industry produced 783 million pounds of pesticides, of
which three-quarters were for domestic use. Insecticides,
rodenticides, and fumigants accounted for 444 million pounds;
herbicides, 226 million; fungicides, 113 million.
It has been reported that about 1 acre in 10 in the continen-
tal United States is treated annually with an average of nearly
4 pounds of pesticides. The farmer uses most of the pesticides.
Fifteen percent of the 460 million acres of farmland in the
United States—69 million acres—produces crops requiring
insecticides—corn, rice, cotton, vegetables, fruits, and nuts.
The Federal Government uses less than 5 percent of all
pesticides used in the United States. About 15 percent of the
total domestic figure is bought for home and garden use.
Some pesticides have hitchhiked great distances and per-
sisted for long periods of time. Air currents, water runoff,
dust particles, and living organisms have been their vehicles.
* * * Residues have even been found in penguins and crabeater
seals in Antarctica. DDT was found in the oil of fish that live
far from land and in those caught off the coasts of four con-
tinents—ranging in concentrations from less than 1 part of
DDT in 1 million parts of oil (1 part per million) to more than
300 parts per million. Often, fish do not die immediately or at
the site of the pesticide exposure. In one recorded case, fish
started dying 3 months after DDT was applied, and death
reached downstream nearly 100 miles from the treatment site.
From 1960 to 1963, of 56 bald eagles found dead or inca-
pacitated in 20 States and two Canadian Provinces, all but one
(from Alaska) contained DDT.
The U.S. Public Health Service has reported traces of one
or more chlorinated hydrocarbons in every major river sys-
tem in the Nation. * * *
Pesticides are particularly significant to the fishing indus-
try. Some of the most valuable species of fish and shellfish are
also the most sensitive to pesticides. Ten marine animal
groups make up 80 percent of the $381.2 million U.S. fishery.
-------
STATUTES AND LEGISLATIVE HISTORY 727
Of the 10, five spend important parts of their lives in estua-
rine waters (where salt and fresh water meet) and are vul-
nerable to pesticides. The five are shrimp, mollusks, Pacific
salmon, crabs, and menhaden (a member of the herring fam-
ily used to make poultry feeds and oil).
During the past 4 years, the researchers have developed
objective methods for measuring effects of pesticides. New
chemicals sent by manufacturers are tested on plankton,
shrimp, crabs, oysters, and one or two species of commercial
fish. The researchers seek to assist in finding narrow-spectrum
pesticides that may be used to control target pests without
harm to other life.
Some pesticides paralyze shrimp or other crustaceans
rather than kill them. The criteria for testing toxicity of this
group are set by learning the concentrations of pesticide that
will cause paralysis or death to half of the sample within 24
[p. 3]
to 48 hours. To learn how much of a pesticide will kill fish, the
researchers treat the fish with low concentrations, about what
might be encountered in the water, and observe them for
months to see whether they store pesticides and what effects
the chemicals have on them.
Since enactment of the 1958 act, the U.S. Fish and Wildlife Serv-
ice has developed a program of pesticides research at four major
locations: Patuxent Wildlife Research Center, Laurel, Md.; Fish-
Pesticide Laboratory, Columbia, Mo.; Denver Wildlife Research
Center, Denver, Colo.; and Shellfish-Pesticide Laboratory, Gulf
Breeze, Fla. Approximately 150 employees are involved in carrying
out this research program of which 33 are in the Bureau of Com-
mercial Fisheries and Wildlife. This highly trained professional
staff consists of biologists, chemists, physiologists, and engineers.
Another explanation for the need of this legislation can be found
in the statement at the hearings by Dr. Stanley A. Cain, Assistant
Secretary of the Interior for Fish and Wildlife and Parks.
He said:
Under the terms of the 1964 interdepartmental agreement,
the Pesticide Registration Division of the Department of the
Interior receives applications daily from the Department of
Agriculture for registration and reregistration of pesticidal
chemicals, according to provisions of the Federal Insecticide,
Fungicide, and Rodenticide Act.
Our staff promptly submits the conclusions of their review
to USDA, advising them of any potential hazard to fish and
-------
728 LEGAL COMPILATION—PESTICIDES
wildlife, and recommending any appropriate modification of
label instructions or warnings. Since July 1964, when the
agreement was signed, the USDA has submitted over 25,000
labels for consideration by the Interior staff. * * *
*******
In 1958 we supported legislation authorizing pesticide
research, and we supported an extension of the legislation in
1959 and 1965. A further extension is needed because the
appropriation authorization terminates on June 30, 1968. * * *
*******
Departmental scientists study the transport of pesticides,
their distribution geographically and in the habitats, their
degradation, and in some cases, accumulation in water and
soil, and especially their biological transfer from one orga-
nism to another along the chains of the food web.
These ecological pesticide research programs can be divided
into four broad categories:
1. Monitoring the levels of pesticide residues in living
resources and their habitats;
2. Physiological studies of the effects of pesticides upon
life processes;
3. Bioassay studies of the lethal and sublethal effects
of pesticides under controlled laboratory conditions;
4. Field appraisal of the immediate and long-term
effects of pesticides upon various species of fish and
wildlife.
[p. 4]
Your committee noted that the President's Science Advisory
Committee issued its report on the "Use of Pesticides," wherein it
recommended expanded research and evaluation by the Department
of the Interior of the toxic effects of pesticides on wild vertebrates
and invertebrates.
Your committee further noted that the President in his message
to the Congress on natural beauty of February 8, 1965, pointed to
the need for increased research in pesticides and recommended the
removal of the ceiling on such research. On March 8,1968, Assistant
Secretary Stanley A. Cain, in a letter to the President, recommended
a draft bill which would extend the program indefinitely without a
dollar ceiling.
Your committee noted that in the last 10 years the amount of
expenditures for pesticide research has increased tenfold and now
approximate $3 million annually. Following is a table indicating
expenditures since the inception of the program.
-------
STATUTES AND LEGISLATIVE HISTORY 729
ANNUAL EXPENDITURES FOR PESTICIDE RESEARCH-U.S. DEPARTMENT OF THE INTERIOR
[In thousands of dollars]
Year BCF BSFW Total
1960
1961
1962
1963
1964
1965
1966
1967
1968 _
Total
33.0
95.0
... .. 95.4
102.2
208.8
506.3
... .. 512.8
... ._ 732.8
714.0
3,000.1
247.0
291.5
583.5
707.6
863.0
1,822.9
1,838.2
2,062.9
2,280.0
10,696.6
280.0
386.5
678.9
809.8
1,071 8
2,329.2
2,351.0
2,795.7
2,994.0
13,696.9
The Department of the Interior witness indicated at the hearings
that because of the increased need for expanded research, projected
plans call for expenditures of approximately $5 million annually
for the next 3 years.
In view of the foregoing, your committee unanimously recom-
mends adoption of H.R. 15979, as amended, which would authorize
to be appropriated $5 million annually for fiscal years 1969, 1970,
and 1971.
WHAT THE BILL DOES—SECTION-BY-SECTION ANALYSIS
Section 1, subsection (a) of the bill, is a restatement of existing
law. It would direct the Secretary of the Interior to undertake a
comprehensive and continuing program of research on the effects
of pesticides and other poisonous chemicals upon our Nation's fish
and wildlife. The purpose of the research would be to determine
amounts, percentages, and formulations of pesticidal chemicals
which could be used safely, and which would prevent losses to this
valuable resource.
Subsection (b) of this section would require the Secretary of the
Interior to make the research information available to the Secre-
tary of Agriculture relative to how pesticidal chemicals may be used
so that injury to fish and wildlife could be prevented or minimized.
It also would require the Secretary of Agriculture, in consultation
with the Secretary of the Interior, to have such information appear
[p. 5]
on the label of each package of such chemicals which is required to
be labeled under the Federal Insecticide, Fungicide, and Rodenticide
Act.
In 1964, an interdepartmental agreement was entered into
among the Departments of the Interior, Agriculture, and Health,
Education, and Welfare, to coordinate the activities of the three
Departments pertaining to pesticides. This agreement outlines the
responsibilities of the respective departments which relate to the
-------
730 LEGAL COMPILATION—PESTICIDES
registration of pesticides and setting the tolerances for pesticide
residues. Further, it requires each Department to keep each of the
other Departments informed of research developments and outlines
procedures for implementing interdepartmental recommendations.
Upon questioning at the hearings, the Department of Agricul-
ture witness admitted that subsection l(b) of section 1 of the bill
would not conflict with existing practices under the law—nor
under the 1964 interdepartmental agreement—nor would it in any
way impinge on the capability of the Departments of the Interior
and Agriculture to do precisely what they are presently doing with
respect to pesticide labeling.
Over the years, your committee has witnessed an immense
increase in toxicity from the use of pesticides and has heard of the
widespread distribution of these chemicals without due regard to
the effects on fish and wildlife. Unfortunately, it appears that the
insect kingdom is holding its own while fish and wildlife are falling
behind, unable to adapt to the increasingly toxic chemicals. In view
of this and in view of the fact the labeling requirements of subsec-
tion (b) of section 1 of the bill are being carried out under the 1964
memorandum of understanding—which could be mutually canceled
upon agreement—your committee feels that more protection would
be afforded fish and wildlife by enacting into law that which is
being carried out under administrative agreement. Accordingly,
your committee retained this provision in the bill.
New section 2 of the 1958 act would authorize the Secretary of
the Interior to conduct programs of evaluating chemicals proposed
for use as pesticide chemicals to determine their potential harm to
fish and wildlife resources and to distribute the results of these
studies to interested people and agencies. In carrying out this pro-
vision of the legislation, the Secretary would be authorized to
operate and maintain existing facilities, including laboratories.
New Section 3 of the 1958 act, as introduced, would authorize to
be appropriated $5 million annually to carry out a pesticide
research program indefinitely.
It was the thinking of your committee that this legislation should
be limited again to a period of 3 years so that, at the termination
of the program, the Congress would have an opportunity to review
the needs of pesticide research.
Accordingly, your committee amended this section to authorize
to be appropriated $5 million for fiscal years 1969, 1970, and 1971.
Section 2 of the bill would delay the effective date of the provi-
sions of the bill until 180 days after enactment.
-------
STATUTES AND LEGISLATIVE HISTORY 731
COST OF THE LEGISLATION
The maximum cost of this legislation authorized by H.R. 15979,
as amended, is $5 million annually for fiscal years 1969, 1970, and
1971.
[p. 6]
DEPARTMENTAL REPORTS,
U.S. DEPARTMENT OF THE INTERIOR,
Washington, D.C., February S3,1968.
Hon. EDWARD A. GARMATZ,
Chairman, Committee on Merchant Marine and Fisheries,
House of Representatives, Washington, D.C.
DEAR MR. CHAIRMAN: Your committee has requested this Department's
report on H.R. 487, a bill to amend the act of August 1, 1958, in order to
prevent or minimize injury to fish and wildlife from the use of insecticides,
herbicides, fungicides, and pesticides, and for other purposes.
We recommend the enactment of H.R. 487 with the changes recommended
herein.
Section 1 of the bill would amend the act of August 1, 1958 (72 Stat. 479;
16 U.S.C. 742d—1), in three ways.
The bill would add a new subsection to section 1 of the act which would
require the Department tq make information available to the Secretary of
Agriculture relative to how pesticides, etc., may be used so that they will
not injure fish or wildlife or so that the injury will be minimized. It would
also require the Secretary of Agriculture to put this information on pesticide
labels.
We believe that this subsection is unnecessary. The objective of the proposed
subsection is the subject of administrative agreement between the Depart-
ments of Interior, Agriculture, and Health, Education, and Welfare.
The bill would add a new section 2 to the 1958 act which would authorize
the Secretary to conduct programs of evaluating chemicals to determine their
potential harm to fish and wildlife resources and to distribute the results of
these studies to interested people and agencies.
Section 7 of the Fish and Wildlife Act of 1956 now directs the Secretary of
the Interior to—
"(4) take such steps as may be required for the development, advance-
ment, management, conservation, and protection of the fisheries re-
sources; and
"(5) take such steps as may be required for the development, manage-
ment, advancement, conservation, and protection of wildlife resources
through research, acquisition of refuge lands, development of existing
facilities, and other means."
In addition, section 5 of that act directs the Secretary to conduct contin-
uing investigations and disseminate information relative to the conserva-
tion and protection of fish and wildlife.
This Department, therefore, has adequate authority under the 1956 act not
only to do all that would be authorized by the new section 2 of the bill, but
also to carry out a comprehensive pesticide research program. Incidentally,
the Department now also has authority to conduct pesticide research in con-
nection with our responsibilities under the Federal Water Pollution Control
Act, as amended.
-------
732 LEGAL COMPILATION—PESTICIDES
We recognize, however, that in 1958 we supported this legislation because
it would provide the emphasis that was then and still is needed to make the
public aware of the problems associated with the use of- pesticides. Again in
1959 and 1965 we supported an extension of the legislation. We still strong-
ly support the program and believe that the legislation should be extended.
We believe, however, that it is not necessary to amend the 1958 act in any way
except to extend it beyond June 30, 1968. This latter change is urgently need-
ed because the appropriation authorization under the 1958 act terminates
on that date. We could, of course, and would continue this important pro-
[p. 7]
gram, and seek appropriations therefor under the authority of the Fish and
Wildlife Act of 1956, if action is not taken on this bill during the 90th Con-
gress. We believe, however, that it would be better to extend the 1958 act
authorization indefinitely without a dollar ceiling, as the President recom-
mended in the 89th Congress.
The Bureau of the Budget has advised that there is no objection to the
presentation of this report from the standpoint of the administration's pro-
gram.
Sincerely yours,
CLARKNCE F. PAUTZKE,
Deputy Assistant Secretary of the Interior.
DEPARTMENT OF AGRICULTURE,
Washington, D.C., February S9,1968.
HON. EDWARD A. GARMATZ,
Chairman, Committee on Merchant Marine and Fisheries,
House of Representatives.
DEAR MR. CHAIRMAN : Thank you for your letter of January 20,1967, giving
us the opportunity to review and report on H.R. 487, a bill entitled, "To amend
the act of August 1, 1958, in order to prevent or minimize injury to fish and
wildlife from the use of insecticides, herbicides, fungicides, and pesticides,
and for other purposes."
The bill would authorize the Secretary of the Interior to conduct a program
of evaluating chemicals proposed for use as pesticides for the purpose of
determining whether the chemicals are harmful or hazardous to fish and
wildlife resources. It provides that on the basis of these studies, the Secretary
of the Interior shall transmit information to the Secretary of Agriculture as
to how injury to fish and wildlife through the use-of insecticides, herbicides,
fungicides, or pesticides can be prevented or minimized, and that the Secre-
tary of Agriculture shall require such information or warning to appear on the
label of each package of such insecticide, herbicide, fungicide, or pesticide
under the authority of the Federal Insecticide, Fungicide, and Rodenticide
Act. The bill further provides that the Secretary of the Interior would dis-
tribute, to interested persons and agencies, both public and private, data col-
lected showing the effects of pesticides and would authorize him to operate
and maintain facilities necessary to carry out the purposes of the bill. H.R.
487 also would authorize the appropriation of the necessary funds to carry
out its purposes. The proposed amendments would be effective 180 days after
the bill's enactment.
This Department has no objection to the proposed bill to the extent that it
-------
STATUTES AND LEGISLATIVE HISTORY 733
would provide new and more extensive research data on the relation of pesti-
cides to fish and wildlife and increased information to this Department for
use in the administration of the Federal Insecticide, Fungicide, and Rodenti-
cide Act. However, we defer to the Department of the Interior as to the need
for this provision.
The provisions of that part of the proposed amendment dealing with the
labeling of products registered under the Federal Insecticide, Fungicide, and
[p. 8]
Rodenticide Act would appear to create the possibility of a conflict of author-
ity between the Secretary of Agriculture and the Secretary of the Interior
in the administration of the act. Further, these provisions are being carried
out administratively through an interdepartmental agreement among the
Departments of Health, Education, and Welfare; the Interior; and Agricul-
ture developed as a result of the President's Science Advisory Committee
report on the "Use of Pesticides."
Therefore, this Department recommends against section 1 (b) of H.R. 487.
The Bureau of the Budget advises that there is no objection to the pre-
sentation of this report from the standpoint of the administration's program.
Sincerely yours,
ORVILLE L. FREEMAN, Secretary.
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,
Washington, D.C., February 26,1968.
HON. EDWARD A. GARMATZ,
Chairman, Committee on Merchant Marine and Fisheries,
House of Representatives, Washington, D.C.
DEAR MR. CHAIRMAN : This letter is in response to your request of January
20, 1967, for a report on H.R. 487, a bill to amend the act of August 1, 1958,
in order to prevent or minimize injury to fish and wildlife from the use of
insecticides, herbicides, fungicides, and pesticides and for other purposes.
Section 1 of H.R. 487 would require the Secretary of the Interior, on the
basis of studies of the effects of insecticides, herbicides, fungicides, or pesti-
cides on fish and wildlife, to transmit to the Secretary of Agriculture informa-
tion as to how, in the use of such chemicals, injury to fish and wildlife can
be prevented or minimized. The Secretary of Agriculture, in consultation with
the Secretary of the Interior, would be required to have such information
appear on the label of each package of pesticides which is required to be
labeled under the Federal Insecticide, Fungicide, and Rodenticide Act.
Section 2 of H.R. 487 would authorize the Secretary of the Interior to con-
duct a program of evaluating chemicals proposed for use as pesticides, to
determine whether the chemicals are harmful or hazardous to fish and wild-
life; to distribute data showing the effects of pesticides on fish and wildlife;
and to operate and maintain facilities necessary to these purposes. It also
provides for an increase in the present appropriations ceiling for the Depart-
ment of Interior.
We are in accord with the objectives of this bill to give due consideration
to the interests of conservation of fish and wildlife in the regulation of pes-
ticides. However, due consideration should be given also to the harmful or
hazardous effects of pesticides on humans, domestic animals, and agricul-
tural crops. We believe, however, that section 1 of the bill, in regard to label-
-------
734 LEGAL COMPILATION—PESTICIDES
ing, is unnecessary. In 1964 an interdepartmental agreement was entered into
between the Departments of Agriculture, Interior, and Health, Education,
and Welfare to coordinate the activities of the three Departments pertaining
to pesticides. This agreement outlines the responsibilities of the respective
[P- 9]
Departments which relate to the registration of pesticides and the setting
of tolerances for pesticide residues. The agreement further provides that
each Department will undertake to keep each of the other Departments fully
informed of developments in knowledge on this subject from research or
other sources which may come into its possession. The agreement also outlines
the procedures to implement these interdepartmental coordination procedures.
This interdepartmental agreement is intended to provide a mechanism for
the efficient coordination of matters relating to pesticides which section 1 of
H.R. 487 undertakes to remedy. A copy of this agreement is attached for your
information.
We defer to the views of the Department of the Interior with respect to sec-
tion 2 of the bill.
We are advised by the Bureau of the Budget that there is no objection to
the presentation of this report from the standpoint of the administration's
program.
Sincerely, WILBUR J. COHEN,
Under Secretary.
MEMORANDUM OP AGREEMENT BETWEEN THE DEPARTMENT OF
AGRICULTURE, THE DEPARTMENT OF THE INTERIOR, AND THE DE-
PARTMENT OF HEALTH, EDUCATION, AND WELFARE ON INTERDE-
PARTMENTAL COORDINATION OF ACTIVITIES RELATING TO PESTI-
CIDES
PURPOSE
Coordination of activities of the three Departments pertaining
to pesticides with special reference to registration and the setting
of tolerances to give effect to the pertinent recommendations of the
May 15, 1963, report of the President's Science Advisory Commit-
tee on "Use of Pesticides."
EXISTING DEPARTMENTAL RESPONSIBILITIES
The following responsibilities of the respective departments
relate to the registration of pesticides and the setting of tolerances
for pesticide residues:
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.
-------
STATUTES AND LEGISLATIVE HISTORY 735
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 effec-
tive use of pesticides, including the registration thereof.
[p. 10]
AGREEMENT
1. Information
Each department undertakes to keep each of the other depart-
ments fully informed of developments in knowledge on this subject
from research or other sources which may come into its posses-
sion. Additionally, the Department of Agriculture undertakes to
furnish to the other two departments on a weekly basis a listing of
all proposals affecting registration and re-registration, and the
Department of Health, Education, and Welfare undertakes to fur-
nish to the other two departments on a weekly basis a listing of all
proposals affecting tolerances. 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.
2. Procedure
(a) Each department will designate a scientist to act on behalf
of such department in carrying out the terms of this agreement.
The weekly listings from the Departments of Agriculture and
Health, Education, and Welfare and any additional information
relating thereto will be directed to these representatives.
(b) The departmental representative will review the weekly
listings of actions pending. If there is reason to question any of the
items on that list, this will be communicated to the originating de-
partment within 1 week stating the specific reason for need for
further review.
(c) Upon receipt of such request the originating department
will furnish the necessary information and make the necessary
arrangements for further review and will withhold final action on
the matter for an additional 3 weeks.
(d) If one department concludes that the proposal should be re-
jected in whole or in part, this view shall be expressed in writing
and shall be supported by appropriate scientific evidence. Upon
being notified, the department responsible for final action will take
the initiative to work out a basis for agreement.
(e) In the event agreement is not reached among the depart-
-------
736 LEGAL COMPILATION—PESTICIDES
ment representatives within 2 weeks of the initial objection, the
matter will then be referred directly to the Secretary of the depart-
ment responsible for final action with such information, views, and
recommendations as the three department representatives deem
appropriate.
(f) The Secretary of the Department charged with final ac-
tion may then avail himself of whatever administrative and sci-
entific review procedures seem appropriate under the circum-
stances. The other two Departments will be notified in advance of
the proposed final determination of the issues.
(g) The Department representatives will jointly make a quar-
terly report concerning their activities to the Secretaries of the
three Departments.
(h) The departmental representatives are authorized to review
questions involving existing patterns of use of pesticides or toler-
ances upon which they have reason to believe that critical ques-
tions exist.
S. Conference
At least once each year the departmental representatives will
arrange a general conference to discuss research needs, research
[p. 11]
program and policy, and the application of research findings in
action programs, including public information relating to pesticides.
4. Federal Pest Control Review Board
The Federal Pest Control Review Board may be asked from time
to time to consider broad questions on policies relating to pesticides
involving the interrelationships of control programs, research, reg-
istration, tolerances, and general departmental recommendations to
the public.
ORVILLE L. FREEMAN,
Secretary, Department of Agriculture
Dated April 8,1964.
STEWART L. UDALL,
Secretary, Department of the Interior
Dated March 27,1964.
ANTHONY J. CELEBREZZE,
Secretary, Department of Health, Education, and Welfare
Dated April 3,1964.
CHANGES IN EXISTING LAW
In compliance with clause 3 of rule XIII of the Rules of the
House of Representatives, as amended, changes in existing law
made by the bill as reported, are shown as follows (existing law
-------
STATUTES AND LEGISLATIVE HISTORY 737
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) :
Act of August 1,1958
(16U.S.C.742d-l)
[That the Secretary of the Interior is authorized and directed to
undertake comprehensive continuing studies on the effects of insec-
ticides, herbicides, fungicides, and pecticides, upon the fish and
wildlife resources of the United States, for the purpose of deter-
mining the amounts, percentages, and formulations of such chem-
icals that are lethal to or injurious to fish and wildlife and the
amounts, percentages, mixtures, or formulations that can be used
safely, and thereby prevent losses of fish and wildlife from such
spraying, dusting, or other treatment.
[SEC. 2. In order to carry out the provisions of this Act, there
are authorized to be appropriated for the fiscal year ending June
30, 1966, not to exceed $3,200,000, and not to exceed $5,000,000 for
each of the two fiscal years immediately following such year.]
That (a) the Secretary of the Interior is authorized and directed
to undertake comprehensive continuing studies on the effects of in-
secticides, herbicides, fungicides, and pesticides, upon the fish and
wildlife resources of the United States, for the purpose of deter-
mining the amounts, percentages, and formulations of such chem-
icals that are lethal to or injurious to fish and wildlife and the
amounts, percentages, mixtures, or formulations that can be used
safely, and thereby prevent losses of fish and wildlife from such
spraying, dusting, or other treatment.
(b) On the basis of the studies carried on pursuant to subsection
(a) of this section, the Secretary of the Interior shall transmit in-
[p. 12]
formation to the Secretary of Agriculture as to how, in the use of
insecticides, herbicides, fungicides, or other pesticides, injury to
fish and wildlife can be prevented or minimized and the Secretary
of Agriculture, in consultation with the Secretary of the Interior,
shall require that such information or warning pertinent to
any insecticide, herbicide, fungicide, or other pesticide shall appear
on the label of each package of such insecticide, herbicide, fungi-
cide, or other pesticide, as the case may be, which is required to be
labeled under the Federal Insecticide, Fungicide, and Rodenticide
Act (7 U.S.C. 135-135k).
SEC. 2. The Secretary of the Interior is authorized—
(1) to conduct a program of evaluating chemicals proposed
for use as insecticides, herbicides, fungicides, or other pesti-
-------
738 LEGAL COMPILATION—PESTICIDES
aides for the purposes of determining whether the chemicals
are harmful or hazardous to the Nation's fish and wildlife
resources;
(2) to distribute to interested persons and agencies, both
public and private, data collected under this Act showing the
effects of insecticides, herbicides, fungicides, or other pesti-
cides; and
(3) to operate and maintain existing facilities, including
laboratories, necessary to carry out the purposes of this Act.
SEC. 3. There is authorized to be appropriated the sum of
$5,000,000 for the fiscal year ending June 30, 1969, and for each of
the two fiscal years immediately following such year.
NOTE.—The amendments made by this Act shall take effect on
the one hundred and eightieth day after the date of enactment of
this Act.
[p. 13]
1.3d (2) SENATE COMMITTEE ON COMMERCE
S. REP. No. 1236, 90th Cong., 2d Sess. (1968)
EFFECTS OF PESTICIDES UPON FISH AND WILDLIFE
JUNE 13, 1968.—Ordered to be printed
Mr. MAGNUSON, from the Committee on Commerce,
submitted the following
REPORT
together with
INDIVIDUAL VIEWS
[To accompany H.R. 15979]
The Committee on Commerce, to which was referred the bill
(H.R. 15979) to amend the act of August 1, 1958, in order to pre-
vent or neutralize injury to fish and wildlife from the use of
pesticides, herbicides, fungicides, and pesticides, and for other pur-
poses, having considered the same, reports favorably thereon with
amendments and recommends that the bill, as amended, do pass.
PURPOSE OF THE BILL
The purpose of the bill, as amended, is to continue the compre-
hensive continuing study of the effects of pesticides upon fish and
wildlife resources, which was authorized in the act of August 1,
1958, as amended, by authorizing annual appropriations under that
-------
STATUTES AND LEGISLATIVE HISTORY 739
act not to exceed $3,500,000 in each of fiscal years 1969, 1970, and
1971.
LEGISLATIVE BACKGROUND
Through enactment of the Pesticides Research Act in 1958, Con-
gress directed the Secretary of the Interior through the Fish and
Wildlife Service to undertake comprehensive continuing studies of
the effects of pesticides upon fish and wildlife resources for the
purpose of determining the amounts and formulations of such
chemicals that are lethal or injurious to such resources and the
amounts or mixtures that can be used safely so as to prevent loss of
fish and wildlife from dusting, spraying, or other use of chemicals.
[p.l]
Under that act, the Fish and Wildlife Service has developed a
program of pesticides research at five major locations: Patuxent
Wildlife Research Center, Laurel, Md.; Fish-Pesticide Laboratory,
Columbia, Mo.; Denver Wildlife Research Center, Denver, Colo.;
Shellfish-Pesticide Laboratory, Gulf Breeze, Fla.; and Biological
Laboratory, Ann Arbor, Mich. Approximately 150 employees are
involved in carrying out this research program of which 34 are in
the Bureau of Sports Fisheries and Wildlife. This highly trained
professional staff consists of biologists, chemists, physiologists,
and engineers.
The results of these research programs are currently being
transmitted to the Department of Agriculture pursuant to a for-
mal memorandum of agreement entered into in 1964 by the Depart-
ment of the Interior, the Department of Agriculture, and the
Department of Health, Education, and Welfare.
Under the terms of that agreement, the Pesticides Registration
Division of the Department of the Interior receives applications
daily from the Department of Agriculture for registration of pest-
icidal chemicals required by the Federal Insecticide, Fungicide, and
Rodenticide Act administered by the Department of Agriculture.
(7U.S.C. 135-135k).
The Pesticides Registration Division of the Department of the
Interior then submits the conclusions of their review of these
applications to the Department of Agriculture advising it of any
potential hazard to fish and wildlife, and recommending any
appropriate modification of label instructions or warning on the
particular pesticidal chemical.
The Department of the Interior, through the Fish and Wildlife
Service, carries out a number of cooperative studies leading to the
discovery and development of more selective and less hazardous
pest control methods; and many other extensive research pro-
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740 LEGAL COMPILATION—PESTICIDES
grams designed to evaluate the potentially injurious effects of
various pesticides on fish and wildlife.
NEED FOR THE LEGISLATION
The amount of pesticidal chemicals being produced and used
increases yearly. In 1964, the U.S. chemical industry produced 783
million pounds of pesticides, of which three-quarters were for
domestic use. In 1967, in the United States alone, 10,000 manufac-
turing firms mixed more than 900 chemical compounds into over
60,000 formulations registered with the Department of Agricul-
ture for use as pesticides. Sales increased an estimated 12 percent
in 1967 over 1966, and, by 1985, it is estimated they will increase
another sixfold.
It has been reported that about 1 acre in every 10 in the conti-
nental United States is treated annually with an average of nearly
4 pounds of pesticides. Most of the pesticides are used on the farm.
Fifteen percent of the 460 million acres of farmland in the United
States—69 million acres—produces crops requiring insecticides—
corn, rice, cotton, vegetables, fruits, and nuts.
Some pesticides have traveled great distances from actual use
and persisted for long periods of time. Air currents, water runoff,
dust particles, and living organisms have been their vehicles. Resi-
dues have even been found in penguins and crab-eater seals in
Antarctica. DDT was found in the oil of fish that live far from land
and in those caught off the coasts of four continents—ranging in
[p. 2]
concentrations from less than one part of DDT in 1 million parts
of oil (one part per million) to more than 300 parts per million.
Often, fish do not die immediately or at the site of the pesticide
exposure. In one recorded case, fish started dying 3 months after
DDT was applied, and death reached downstream nearly 100 miles
from the treatment site.
From 1960 to 1963, of 56 bald eagles found dead or incapacitated
in 20 States and two Canadian Provinces, all but one (from
Alaska) contained DDT.
The U.S. Public Health Service has reported traces of one or
more chlorinated hydrocarbons in every major river system in the
Nation.
Pesticides are particularly significant to the fishing industry.
Some of the most valuable species of fish and shellfish are also the
most sensitive to pesticides. Ten marine animal groups make up 80
percent of the $381.2 million fishing industry of the United States.
Of the 10, five spend important parts of their lives in estuarine
-------
STATUTES AND LEGISLATIVE HISTORY 741
waters (where salt and fresh water meet) and are vulnerable to
pesticides. The five are shrimp, mollusks, Pacific salmon, crabs,
and menhaden (a member of the herring family used to make poul-
try feeds and oil).
During the past 4 years, Fish and Wildlife Service researchers
have developed objective methods for measuring effects of pesti-
cides. New chemicals sent by manufacturers are tested on plank-
ton, shrimp, crabs, oysters, and one or two species of commercial
fish. The researchers seek to assist in finding narrow-spectrum
pesticides that may be used to control target pests without harm to
other life.
Some pesticides paralyze shrimp or other crustaceans rather
than kill them. The criteria for testing toxicity of this group are
set by learning the concentrations of pesticide that will cause
paralysis or death to half of the sample within 24 to 48 hours. To
learn how much of a pesticide will kill fish, the researchers treat
the fish with low concentrations, about what might be encountered
in the water, and observe them for months to see whether they
store pesticides and what effects the chemicals have on them.
Your committee has been further advised by the Department of
the Interior that studies of the past few years have highlighted
three types of research priorities:
1. Residue levels in animal bodies that indicate hazards to nor-
mal reproduction and behavior.—Experimental studies especially
designed to determine quantities of pesticides in wild animals and
their environments are necessary. Toxic limits should be estab-
lished for the various chlorinated hydrocarbons and heavy metals
(lead, mercury) found in animal tissues, together and separately.
Variations in toxicity due to species differences in sensitivity, and
variations due to stresses on individuals should be determined.
2. Quantities of residues in the fish and wildlife environment.—
This would supplement the general information obtained in the
national monitoring program. The environments of declining spe-
cies such as golden eagles, pelicans, ospreys, and of truly rare and
endangered species such as the southern bald eagle should be
studied. Estuarine areas, inland waters, forests, and grazing lands
—all historically have supported significant wildlife populations.
Perceptive investigations there should focus on residues in the
major animals and the food organisms in these habitats.
[p. 3]
3. Changes and flows of residue levels.—Rates and pathways of
gain and loss in various wild animals and their environments
should be identified. New chemical factors have been entering the
-------
742 LEGAL COMPILATION—PESTICIDES
lives and habitats of animals in recent years. Where they come
from, where they go, and hazards or lack of hazards they pose
while residing in wildlife need to be learned.
HEARINGS AND COMMITTEE CONSIDERATION OF THE BILL
H.R. 15979, as it passed the House of Representatives, would
restate the Pesticides Research Act of 1958.
In addition, it would add a new subsection 1 (b) to that law
requiring the Secretary of the Interior to make research informa-
tion available to the Secretary of Agriculture as to how in the use
of pesticidal chemicals injury to fish and wildlife can be prevented
or minimized. The Secretary of Agriculture, after consultation
with the Secretary of the Interior, would then be required to have
such information appear on the label of each package of pesticides
required to be labeled under the Federal Insecticide, Fungicide, and
Rodenticide Act.
The bill would also add a new section 2 to the existing law
authorizing the Secretary of the Interior to conduct programs of
evaluating chemicals proposed for use as pesticide chemicals to
determine their potential harm to fish and wildlife resources and
to distribute the results of these studies to interested people and
agencies.
Under the bill, as approved by the House, $5 million annually
would be authorized to be appropriated for fiscal years 1969, 1970,
and 1971. However, the provisions of the bill including the author-
ization would not become effective until 180 days after its
enactment.1
Hearings on H.R. 15979 were held on May 17 of this year. Your
committee heard extensive testimony from the Department of the
Interior, the Department of Agriculture, and other interested wit-
nesses. All favored the continuation of the comprehensive pesti-
cides research program being carried out under the Pesticides
Research Act of 1958. The Department of the Interior urged that
the authorization provision be amended to become effective July 1,
1968. Otherwise there would be a hiatus in the programs carried
out under that act, because the current authorization for funds
expires on June 30,1968.
The Department of Agriculture opposed the labeling provision of
new subsection 1 (b) because it felt it would appear to conflict with
the authority of the Secretary of Agriculture in the administration
IS. 3228 (introduced by request of the Department of the Interior by Senator Magnuson) would
have extended the authorization for appropriations under the act of Aug. 1, 1958, for fiscal year
1969 and each succeeding fiscal year such sums as may be necessary to carry out the purposes
of that act.
-------
STATUTES AND LEGISLATIVE HISTORY 743
of the Federal Insecticide, Fungicide, and Rodenticide Act. And
further, that the objectives of subsection l(b) are now accom-
plished under the interdepartmental agreement among the Depart-
ments of Agriculture, Interior, and Health, Education, and Welfare.
It was strongly supported in its opposition to subsection 1 (b) by
the National Agricultural Chemicals Association.
The National Wildlife Federation and a number of conservation
groups, on the other hand, favored the labeling provision contend-
ing that the final authority should rest with the Secretary of the
Interior for determining whether information concerning the dan-
[p. 4]
ger of potential injury of a particular pesticide to fish and wildlife
should appear on the label of that pesticide.
In this connection, your committee particularly noted the testi-
mony of the Department of the Interior. Although it did not urge
enactment of subsection l(b), the Department of the Interior did
state that its pesticidal research program is centered on evaluating
possible pesticidal side effects on the numerous species of fish and
wildlife and their necessary foods and environments. Consequently
its program used different techniques and approaches than the
research program carried out by the Department of Agriculture
which concentrates its studies primarily on target pests.
Most of the witnesses testified that the successful operation of
the interdepartmental agreement achieved through the effective
cooperation of the departments involved makes additional statu-
tory authority unnecessary at this time.
On the contrary, the two Departments affected testified that the
existing interdepartmental agreement accomplishes the same result
and was working effectively. In 1967, for example, a total of 6,544
label proposals under the Federal Insecticide, Fungicide, and
Rodenticide Act were referred to the Department of the Interior
by the Department of Agriculture pursuant to the interdepart-
mental agreement. Where the Department of the Interior provided
additional advice concerning these referrals, the Department of
Agriculture concurred in all but five or six.
Accordingly, H.R. 15979 has been amended by striking the pro-
posed subsection 1 (b).
Your committee also felt section 2 of H.R. 15979 should be
amended so that it would become effective immediately upon enact-
ment. Accordingly, that provision was also deleted. The amounts
authorized to be appropriated for fiscal years 1969, 1970, and 1971
were also revised downward to $3.5 million annually.
The testimony heard was unanimous in support of the present
-------
744 LEGAL COMPILATION—PESTICIDES
continuing pesticidal research program being carried out by the
Department of the Interior under the Pesticides Research Act.
Since the authorization for funds under that act expires at the end
of fiscal 1968, unless the new authorization becomes effective upon
enactment of H.R. 15979, the program would be halted, at least
temporarily.
H.R. 15979, as approved by the House of Representatives, con-
tained a 3-year $5 million annual authorization ceiling. As
amended, by your committee, the annual ceiling for the fiscal years
1969, 1970, and 1971 would be $3.5 million. It is felt that this
amount while providing room for growth, more accurately reflects
the need for annual appropriations and expenditures for the pro-
gram.
That part of H.R. 15979 which restates the act of August 1,
1958, has been deleted as unnecessary.
Similarly, your committee has deleted that provision in H.R.
15979 which would have added a provision to the Pesticides
Research Act authorizing the Secretary of the Interior to conduct
programs of evaluating the effects of pesticidal chemicals to deter-
mine their potential harm to fish and wildlife, and to distribute this
material to interested persons and agencies, It was felt that what
this section would require is currently authorized under existing
laW" [p. 5]
Finally, the title of H.R. 15979 has been amended to reflect more
accurately what effect the bill has on the act of August 1,1958.
CONCLUSION
According to the President's Science Advisory Committee, the
worldwide use of pesticides will grow from 120,000 metric tons
per year to 700,000 metric tons because the overall amount of
poisons needed to control pests will grow with the increasing
demand for food and fiber.
It seems evident that such massive applications of pesticides will
have a profound effect on other living organisms, including fish
and wildlife. It is, therefore, important that every possible precau-
tion be taken to minimize damages to these living resources. Con-
tinued and comprehensive research of the kind now being carried
out by the Department of the Interior and precautionary measures
will be assured by enactment of this legislation. r fi,
INDIVIDUAL VIEWS OF MESSRS. HART AND MAGNUSON
The emphasis and techniques of the Department of the Interior
in pesticidal research are directed specifically toward danger to
-------
STATUTES AND LEGISLATIVE HISTORY
745
fish and wildlife, whereas the Department of Agriculture specifi-
cally seeks to identify protection of crops and elimination of pests.
I believe the action of the House in adding subsection l(b) was
wise and I oppose the elimination of this labeling provision. The
fact that the Department of Agriculture concurred with the De-
partment of the Interior in all but five or six of more than 6,500
label proposals in 1967, does not persuade me that subsection 1 (b)
is unnecessary. These five or six instances can be said to support
the desirability that when danger to fish and wildlife is identified
by Interior, the law should require that such information appear
on the labels of the pesticide in question.
[p-15]
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 italic,
and existing law in which no change is proposed is shown in roman) :
ACT OF AUGUST 1, 1958
(72 Stat. 479, as amended, 79 Stat. 902)
[SEC. 2. In order to carry out the provisions of this Act, there is
authorized to be appropriated for the fiscal year ending June 30,
1966, not to exceed $3,200,000, and not to exceed $5,000,000 for
each of the two fiscal years immediately following such year.]
SEC. 2. In order to carry out the provisions of this Act, there is
authorized to be appropriated the sum of $3,500,000 for the fiscal
year ending June 30, 1969, and for each of the two fiscal years
immediately following such year. Such sums shall remain avail-
able until expended.
[p.16]
1.3d (3) CONGRESSIONAL RECORD, VOL. 114 (1968)
1.3d (3) (a) June 24: Passed Senate, pp. 18356-18357
order to prevent or minimize injury to
fish and wildlife from the use of in-
secticides, herbicides, fungicides, and
pesticides, and for other purposes.
The PRESIDING OFFICER. Is
there objection to the present consider-
ation of the bill?
There being no objection, the Sen-
ate proceeded to consider the bill,
which had been reported from the Com-
mittee on Commerce, with an amend-
MINIMIZING INJURY TO FISH
AND WILDLIFE
Mr. MANSFIELD. Mr. President, I
ask unanimous consent that the Senate
proceed to the consideration of Calen-
dar No. 1213, H.R. 15979.
The PRESIDING OFFICER. The
bill will be stated by title.
The LEGISLATIVE CLERK. H.R. 15979,
to amend the act of August 1, 1958, in
-------
746
LEGAL COMPILATION—PESTICIDES
ment, to strike out all after the enact-
ing clause and insert:
SEC. 2. In order to carry out the provisions
of this Act, there is authorized to be appropri-
ated the sum of $3,500,000 for the fiscal year
ending June 30, 1969, and for each of the two
fiscal years immediately following such year.
Such sums shall remain available until ex-
pended.
The PRESIDING OFFICER. The
question is on agreeing to the amend-
ment.
The amendment was agreed to.
The amendment was ordered to be
engrossed and the bill to be read a
third time.
The bill was read the third time and
passed.
The title was amended, so as to read:
"An act to amend section 2 of the act
of August 1,1958, as amended in order
to prevent or minimize injury to fish
and wildlife from the use of insecti-
cides, herbicides, fungicides, and other
pesticides."
Mr. MANSFIELD. Mr. President,
I ask unanimous consent to have print-
[p. 18356]
ed in the RECORD an excerpt from the
report (No. 1236), explaining the pur-
poses of the bill.
There being no objection, the excerpt
was ordered to be printed in the REC-
ORD, as follows:
[p. 18357]
1.3d (3) (b) June 27: Passed House, p. 19095
Mr. DINGELL. Mr. Speaker, I ask
unanimous consent to take from the
Speaker's desk the bill (H.R. 15979) to
amend the act of August 1,1958, in or-
der to prevent or minimize injury to
fish and wildlife from the use of insect-
icides, herbicides, fungicides, and pes-
ticides, and for other purposes, with
Senate amendments thereto, and con-
cur in the Senate amendments.
*****
The SPEAKER. Is there objection
to the request of the gentleman from
Michigan?
Mr. GROSS. Mr. Speaker, reserving
the right to object, I would ask the
gentleman from Michigan whether the
Senate amendments are germane to
the bill?
Mr. DINGELL. If the gentleman
will yield, I would say that all amend-
ments are germane.
Mr. GROSS. How did the House
come out financially?
Mr. DINGELL. If the gentleman
will yield further, I will be most pleased
to answer the gentleman from Iowa.
The House bill provided $5 million
over a period of 3 fiscal years. The
Senate bill provided $3.5 million over
the same 3 fiscal years, which was a
cut of $1.5 million per fiscal year.
The Senate struck out the labeling
requirements that had been inserted in
the House. So that all that remains is
the authorization to spend $3.5 million
a year for each of three fiscal years in
extension of an existing program
which passed this House in years past
unanimously, without the labeling re-
quirements which had been in the bill.
Mr. GROSS. Mr. Speaker, I thank
the gentleman from Michigan for his
explanation, and withdraw my reser-
vation of objection.
The SPEAKER. Is there objection
to the request of the gentleman from
Michigan?
There was no objection.
The Senate amendments were con-
curred in.
A motion to reconsider was laid on
the table.
[p. 19095]
-------
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 history)
PART A.—RESEARCH AND INVESTIGATIONS
§ 241. Research and investigations generally
The Surgeon General shall conduct in the Service, and en-
courage, cooperate with, and render assistance to other appro-
priate public authorities, scientific institutions, and scientists in
the conduct of, and promote the coordination of, research, investi-
gations, experiments, demonstrations, and studies relating to the
causes, diagnosis, treatment, control, and prevention of physical
and mental diseases and impairments of man, including water
purification, sewage treatment, and pollution of lakes and streams.
In carrying out the foregoing the Surgeon General is authorized
to—
(a) Collect and make available through publications and other
appropriate means, information as to, and the practical applica-
tion of, such research and other activities ;
(b) Make available research facilities of the Service to ap-
propriate public authorities, and to health officials and scientists
engaged in special study;
(c) Establish and maintain research fellowships in the Service
with such stipends and allowances, including traveling and sub-
sistence expenses, as he may deem necessary to procure the as-
sistance of the most brilliant and promising research fellows from
the United States and abroad;
(d) Make grants-in-aid to universities, hospitals, laboratories,
and other public or private institutions, and to individuals for
such research or research training projects as are recommended
by the National Advisory Health Council, or, with respect to
cancer, recommended by the National Advisory Cancer Council, or,
with respect to mental health, recommended by the National
Advisory Mental Health Council, or, with respect to heart di-
seases recommended by the National Advisory Heart Council or,
with respect to dental diseases and conditions, recommended by
the National Advisory Dental Research Council; and include in the
grants for any such project grants of penicillin and other anti-
biotic compounds for use in such project; and make, upon recom-
mendation of the National Advisory Health Council, grants-in-aid
to public or nonprofit universities, hospitals, laboratories, and
other institutions for the general support of their research and
research training programs: Provided, That such uniform per-
centage, not to exceed 15 per centum, as the Surgeon General
may determine, of the amounts provided for grants for research
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748 LEGAL COMPILATION—PESTICIDES
or research training projects for any fiscal year through the ap-
propriations for the National Institutes of Health may be trans-
ferred from such appropriations to a separate account to be avail-
able for such research and research training program grants-in-
aid for such fiscal year;
(e) Secure from time to time and for such periods as he
deems advisable, the assistance and advice of experts, scholars,
and consultants from the United States or abroad;
(f) For purposes of study, admit and treat at institutions, hos-
pitals, and stations of the Service, persons not otherwise eligible
for such treatment;
(g) Make available, to health officials, scientists, and appropri-
ate public and other nonprofit institutions and organizations,
technical advice and assistance on the application of statistical
methods to experiments, studies, and surveys in health and medi-
cal fields;
(h) Enter into contracts during the fiscal year ending June
30, 1966, and each of the eight succeeding fiscal years, including
contracts for research in accordance with and subject to the
provisions of law applicable to contracts entered into by the mili-
tary departments under sections 2353 and 2354 of Title 10, except
that determination, approval, and certification required thereby
shall be by the Secretary of Health, Education, and Welfare; and
(i) Adopt, upon recommendation of the National Advisory
Health Council, or, with respect to cancer, upon recommendation
of the National Advisory Cancer Council, or, with respect to
mental health, upon recommendation of the National Advisory
Mental Health Council, or, with respect to heart diseases, upon
recommendation of the National Advisory Heart Council, or, with
respect to dental diseases and conditions, upon recommendations
of the National Advisory Dental Research Council, such addi-
tional means as he deems necessary or appropriate to carry out
the purposes of this section.
July 1, 1944, c. 373, Title III, § 301, 58 Stat. 691; July 3, 1946, c.
538, § 7(a, b), 60 Stat. 423; June 16, 1948, c. 481, § 4(e, f), 62
Stat. 467; June 24, 1948, c. 621, § 4(e, f), 62 Stat. 601; June 25,
1948, c. 654, § 1, 62 Stat. 1017; July 3, 1956, c. 510, § 4, 70 Stat.
490; Sept. 15, 1960, Pub.L. 86-798, 74 Stat. 1053; Oct. 17, 1962,
Pub.L. 87-838, § 2, 76 Stat. 1073; Aug. 9, 1965, Pub.L. 89-115,
§ 3, 79 Stat. 448; Dec. 5, 1967, Pub.L. 90-174, § 9, 81 Stat. 540;
and amended Oct. 30, 1970, Pub.L. 91-515, Title II, § 292, 84 Stat.
1308.
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STATUTES AND LEGISLATIVE HISTORY 749
Part B.—Federal-State Cooperation
§ 243. General grant of authority for cooperation—Enforce-
ment of quarantine regulations; prevention of communicable di-
seases
(a) The Secretary is authorized to accept from State and local
authorities any assistance in the enforcement of quarantine regu-
lations made pursuant to this chapter which such authorities may
be able and willing to provide. The Secretary shall also assist
States and their political subdivisions in the prevention and sup-
pression of communicable diseases, shall cooperate with and aid
State and local authorities in the enforcement of their quarantine
and other health regulations and in carrying out the purposes
specified in section 246 of this title, and shall advise the several
States on matters relating to the preservation and improvement
of the public health.
Comprehensive and continuing planning; training of personnel for State and
local health work
(b) The Secretary shall encourage cooperative activities be-
tween the States with resepct to comprehensive and continuing
planning as to their current and future health needs, the estab-
lishment and maintenance of adequate public health services, and
otherwise carrying out the purposes of section 246 of this title.
The Secretary is also authorized to train personnel for State and
local health work.
Problems resulting from disasters; emergencies; reimbursement of United
States
(c) The Secretary may enter into agreements providing for
cooperative planning between Public Health Service medical fa-
cilities and community health facilities to cope with health prob-
lems resulting from disasters, and for participation by Public
Health Service medical facilities in carrying out such planning.
He may also, at the request of the appropriate State or local
authority, extend temporary (not in excess of forty-five days)
assistance to States or localities in meeting health emergencies
of such a nature as to warrant Federal assistance. The Secretary
may require such reimbursement of the United States for aid
(other than planning) under the preceding sentences of this
subsection as he may determine to be reasonable under the cir-
cumstances. Any reimbursement so paid shall be credited to the
applicable appropriation of the Public Health Service for the
year in which such reimbursement is received.
July 1, 1944, c. 373, Title III, § 311, 58 Stat. 693; Nov. 3, 1966,
Pub.L. 89-749, § 5, 80 Stat. 1190; Dec. 5, 1967, Pub.L. 90-174,
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750 LEGAL COMPILATION—PESTICIDES
§ 4, 81 Stat. 536; and amended Oct. 30, 1970, Pub.L. 91-515, Title
II, § 282, 84 Stat. 1308.
§ 246. Grants and services to States—Comprehensive health
planning and services
(a) (1) In order to assist the States in comprehensive and con-
tinuing planning for their current and future health needs, the
Secretary is authorized during the period beginning July 1,
1966, and ending June 30, 1973, to make grants to States which
have submitted, and had approved by the Secretary, State plans
for comprehensive State health planning. For the purposes of car-
rying out this subsection, there are hereby authorized to be ap-
propriated $2,500,000 for the fiscal year ending June 30, 1967,
$7,000,000 for the fiscal year ending June 30, 1968, $10,000,000
for the fiscal year ending June 30, 1969, $15,000,000 for the
fiscal year ending June 30, 1970, $15,000,000 for the fiscal year
ending June 30, 1971, $17,000,000 for the fiscal year ending June
30, 1972, and $20,000,000 for the fiscal year ending June 30, 1973.
(2) In order to be approved for purposes of this subsection, a
State plan for comprehensive State health planning must—
(A) designate, or provide for the establishment of, a single
State agency, which may be an interdepartmental agency, as
the sole agency for administering or supervising the ad-
ministration of the State's health planning functions under
the plan;
(B) Provide for the establishment of a State health plan-
ning council, which shall include representatives of Federal,
State, and local agencies (including as an ex officio member,
if there is located in such State one or more hospitals or
other health care facilities of the Veterans' Administration,
the individual whom the Administrator of Veterans' Af-
fairs shall have designated to serve on such council as the
representative of the hospitals or other health care facilities
of such Administration which are located in such State)
and nongovernmental organizations and groups concerned
with health, (including representation of the regional medi-
cal program or programs included in whole or in part within
the State) and of consumers of health services, to advise such
State agency in carrying out its functions under the plan,
and a majority of the membership of such council shall consist
of representatives of consumers of health services;
(C) set forth policies and procedures for the expenditure
of funds under the plan, which, in the judgment of the Secre-
tary are designed to provide for comprehensive State plan-
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STATUTES AND LEGISLATIVE HISTORY 751
ning for health services (both public and private) and in-
cluding home health care, including the facilities and persons
required for the provision of such services, to meet the
health needs of the people of the State and including en-
- vironmental considerations as they relate to public health;
(D) provide for encouraging cooperative efforts among
governmental or nongovernmental agencies, organizations
and groups concerned with health services, facilities, or man-
power, and for cooperative efforts between such agencies, or-
ganizations, and groups and similar agencies, organizations,
and groups in the fields of education, welfare, and rehabilita-
tion;
(E) contain or be supported by assurances satisfactory
to the Secretary that the funds paid under this subsection
will be used to supplement and, to the extent practicable,
to increase the level of funds that would otherwise be made
available by the State for the purpose of comprehensive
health planning and not to supplant such non-Federal funds;
(F) provide such methods of administration (including
methods relating to the establishment and maintenance of
personnel standards on a merit basis, except that the Secre-
tary shall exercise no authority with respect to the selection,
tenure of office, and compensation of any individual employed
in accordance with such methods) as are found by the Secre-
tary to be necessary for the proper and efficient operation of
the plan;
(G) provide that the State agency will make such reports,
in such form and containing such information, as the Secre-
tary may from time to time reasonably require, and will
keep such records and afford such access thereto as the Secre-
tary finds necessary to assure the correctness and verifica-
tion of such reports;
(H) provide that the State agency will from time to time,
but not less often than annually, review its State plan ap-
proved under this subsection and submit to the Secretary
appropriate modifications thereof;
(I) effective July 1, 1968, (i) provide for assisting each
health care facility in the State to develop a program for
capital expenditures for replacement, modernization, and
expansion which is consistent with an overall State plan de-
veloped in accordance with criteria established by the Secre-
tary after consultation with the State which will meet the
needs of the State for health care facilities, equipment, and
services without duplication and otherwise in the most ef-
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752 LEGAL COMPILATION—PESTICIDES
ficient and economical manner, and (ii) provide that the
State agency furnishing such assistance will periodically re-
view the program (developed pursuant to clause (i)) of
each health care facility in the State and recommend ap-
propriate modification thereof;
(J) provide for such fiscal control and fund accounting
procedures as may be necessary to assure proper disburse-
ment of and accounting for funds paid to the State under
this subsection; and
(K) contain such additional information and assurances
as the Secretary may find necessary to carry out the purposes
of this subsection.
(3) (A) From the sums appropriated for such purpose for
each fiscal year, the several States shall be entitled to allotments
determined, in accordance with regulations, on the basis of the
population and the per capita income of the respective States;
except that no such allotment to any State for any fiscal year shall
be less than 1 per centum of the sum appropriated for such fiscal
year pursuant to paragraph (1). Any such allotment to a State
for fiscal year shall remain available for obligation by the State,
in accordance with the provisions of this subsection and the
State's plan approved thereunder, until the close of the succeeding
fiscal year.
(B) The amount of any allotment to a State under subpara-
graph (A) for any fiscal year which the Secretary determines
will not be required by the State, during the period for which it
is available, for the purposes for which alloted shall be available
for reallotment by the Secretary from time to time, on such date
or dates as he may fix, to other States with respect to which such
a determination has not been made, in proportion to the original
allotments to such States under subparagraph (A) for such fiscal
year, but with such proportionate amount for any of such other
States being reduced to the extent it exceeds the sum the Secre-
tary estimates such State needs and will be able to use during
such period; and the total of such reductions shall be similarly
reallotted among the States whose proportionate amounts were
not so reduced. Any amount so reallotted to a State from funds
appropriated pursuant to this subsection for a fiscal year shall
be deemed part of its allotment under subparagraph (A) for
such fiscal year.
(4) From each State's allotment for a fiscal year under this
subsection, the State shall from time to time be paid the Federal
share of the expenditures incurred during that year or the suc-
ceeding year pursuant to its State plan approved under this sub-
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STATUTES AND LEGISLATIVE HISTORY 753
section. Such payments shall be made on the basis of estimates
by the Secretary of the sums the State will need in order to per-
form the planning under its approved State plan under this sub-
section, but with such adjustments as may be necessary to take
account of previously made underpayments or overpayments. The
"Federal share" for any State for purposes of this subsection
shall be all, or such part as the Secretary may determine, of
the cost of such planning, except that in the case of the allot-
ments for the fiscal year ending June 30, 1970, it shall not exceed
75 per centum of such cost.
Project grants for area wide health planning; authorization of appropriations;
prerequisites for grants; application; contents
(b) (1) (A) The Secretary is authorized, during the period
beginning July 1, 1966, and ending June 30, 1973, to make, with
the approval of the State agency administering or supervising the
administration of the State plan approved under subsection (a)
of this section, project grants to any other public or nonprofit
private agency or organization (but with appropriate representa-
tion of the interests of local government where the recipient of
the grant is not a local government or combination thereof on an
agency of such government or combination) to cover not to exceed
75 per centum of the cost of projects for developing (and from
time to time revising) comprehensive regional, metropolitan
area, or other local area plans for coordination of existing and
planned health services, including the facilities and persons re-
quired for provision of such services; and including the provision
of such services through home health care except that in the
case of project grants made in any State prior to July 1, 1968,
approval of such State agency shall be required only if such State
has such a State plan in effect at the time of such grants. No
grant may be made under this subsection after June 30, 1970,
to any agency or organization to develop or revise health plans
for an area unless the Secretary determines that such agency or
organization provides means for appropriate representation of the
interests of the hospitals, other health care facilities, and practic-
ing physicians serving such area, and the general public. For the
purposes of carrying out this subsection, there are hereby au-
thorized to be appropriated $5,000,000 for the fiscal year ending
June 30, 1967, $7,500,000 for the fiscal year ending June 30, 1968,
$10,000,000 for the fiscal year ending June 30, 1969, $15,000,000
for the fiscal year ending June 30, 1970, $20,000,000 for the
fiscal year ending June 30, 1971, $30,000,000 for the fiscal year
ending June 30, 1972, and $40,000,000 for the fiscal year ending
June 30,1973.
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754 LEGAL COMPILATION—PESTICIDES
(B) Project grants may be made by the Secretary under sub-
paragraph (A) to the State agency administering or supervising
the administration of the State plan approved under subsection
(a) of this section with respect to a particular region or area,
but only if (i) no application for such a grant with respect to
such region or area has been filed by any other agency or or-
ganization qualified to receive such a grant, and (ii) such State
agency certifies, and the Secretary finds, that ample opportunity
has been afforded to qualified agencies and organizations to file
application for such a grant with respect to such region or
area and that it is improbable that, in the foreseeable future,
any agency or organization which is qualified for such a grant will
file application therefor.
(2) (A) In order to be approved under this susbection, an ap-
plication for a grant under this subsection must contain or be
supported by reasonable assurances that there has been or will
be established, in or for the area with respect to which such grant
is sought, an areawide health planning council. The membership
of such council shall include representatives of public, voluntary,
and nonprofit private agencies, institutions, and organizations
concerned with health (including representatives of the interests
of local government, of the regional medical program for such
areas, and of consumers of health services). A majority of the
members of such council shall consist of representatives of con-
sumers of health services.
(B) In addition, an application for a grant under this subsec-
tion must contain or be supported by reasonable assurances that
the areawide health planning agency has made provision for as-
sisting health care facilities in its area to develop a program for
capital expenditures for replacement, modernization, and expan-
sion which is consistent with an overall State plan which will
meet the needs of the State and the area for health care facilities,
equipment, and services without duplication and otherwise in the
most efficient and economical manner.
Project grants for training, studies, and demonstrations; authorization of
appropriations
(c) The Secretary is also authorized, during the period be-
ginning July 1, 1966, and ending June 30, 1973, to make grants
to any public or nonprofit private agency, institution, or other
organization to cover all or any part of the cost of projects for
training, studies, or demonstrations looking toward the develop-
ment of improved or more effective comprehensive health plan-
ning throughout the Nation. For the purposes of carrying out this
subsection, there are hereby authorized to be appropriated $1,-
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STATUTES AND LEGISLATIVE HISTORY 755
500,000 for the fiscal year ending June 30, 1967, $2,500,000 for
the fiscal year ending June 30, 1968, $5,000,000 for the fiscal
year ending June 30, 1969, $7,500,000 for the fiscal year ending
June 30, 1970, $8,000,000 for the fiscal year ending June 30,
1971, $10,000,000 for the fiscal year ending June 30, 1972, and
$12,000,000 for the fiscal year ending June 30,1973.
Grants for comprehensive public health services; authorization of appropria-
tions; State plans; allotments; payments to States; Federal share;
allocation of funds
(d) (1) There are authorized to be appropriated $70,000,000
for the fiscal year ending June 30, 1968, $90,000,000 for the fiscal
year ending June 30, 1969, $100,000,000 for the fiscal year ending
June 30, 1970, $130,000,000 for the fiscal year ending June 30,
1971, $145,000,000 for the fiscal year ending June 30, 1972, and
$165,000,000 for the fiscal year ending June 30, 1973, to enable
the Secretary to make grants to State health or mental health
authorities to assist the States in establishing and maintaining
adequate public health services, including the training of person-
nel for State and local health work. The sums so appropriated
shall be used for making payments to States which have sub-
mitted, and had approved by the Secretary, State plans for pro-
vision of public health services, except that, for any fiscal year
ending after June 30, 1968, such portion of such sums as the
Secretary may determine, but not exceeding 1 per centum thereof,
shall be available to the Secretary for evaluation (directly or by
grants or contracts) of the program authorized by this subsection
and the amount available for allotments hereunder shall be re-
duced accordingly.
(2) In order to be approved under this subsection, a State plan
for provision of public health services must—
(A) provide for administration or supervision of adminis-
tration by the State health authority or, with respect to
mental health services, the State mental health authority;
(B) set forth the policies and procedures to be followed
in the expenditure of the funds paid under this subsection;
(C) contain or be supported by assurances satisfactory to
the Secretary that (i) the funds paid to the State under this
subsection will be used to make a significant contribution
toward providing and strengthening public health services in
the various political subdivisions in order to improve the
health of the people; (ii) such funds will be made available
to other public or nonprofit private agencies, institutions, and
organizations, in accordance with criteria which the Secre-
tary determines are designed to secure maximum participa-
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756 LEGAL COMPILATION—PESTICIDES
tion of local, regional, or metropolitan agencies and groups
in the provision of such services; (iii) such funds will be
used to supplement and, to the extent practical, to increase
the level of funds that would otherwise be made available
for the purposes for which the Federal funds are provided
and not to supplant such non-Federal funds; and (iv) the
plan is compatible with the total health program of the State;
(D) provide for the furnishing of public health services
under the State plan in accordance with such plans as have
been developed pursuant to subsection (a) of this section;
(E) provide that public health services furnished under
the plan will be in accordance with standards prescribed by
regulations, including standards as to the scope and quality
of such services;
(F) provide such methods of administration (including
methods relating to the establishment and maintenance of
personnel standards on a merit basis, except that the Secre-
tary shall exercise no authority with respect to the selection,
tenure of office, and compensation of any individual employed
in accordance with such methods) as are found by the Secre-
tary to be necessary for the proper and efficient operation
of the plan;
(G) provide that the State health authority or, with re-
spect to mental health services, the State mental health au-
thority will from time to time, but not less often than annu-
ally, review and evaluate its State plan approved under this
subsection and submit to the Secretary appropriate modifica-
tions thereof;
(H) provide that the State health authority or, with re-
spect to mental health services, the State mental health
authority, will make such reports, in such form and con-
taining such information, as the Secretary may from time to
time reasonably require, and will keep such records and af-
ford such access thereto as the Secretary finds necessary to
assure the correctness and verification of such reports;
(I) provide for such fiscal control and fund accounting
procedures as may be necessary to assure the proper dis-
bursement of and accounting for funds paid to the State
under this subsection;
(J) contain such additional information and assurances
as the Secretary may find necessary to carry out the pur-
poses of this subsection;
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STATUTES AND LEGISLATIVE HISTORY 757
(K) provide for services for the prevention and treat-
ment of drug abuse and drug dependence, commensurate with
the extent of the problem; and
(L) provide for services for the prevention and treatment
of alcohol abuse and alcoholism, commensurate with the ex-
tent of the problem.
(3) From the sums appropriated to carry out the provisions
of this subsection the several States shall be entitled for each
fiscal year to allotments determined, in accordance with regula-
tions, on the basis of the population and financial need of the
respective States, except that no State's allotment shall be less
for any year than the total amounts allotted to such State under
formula grants for cancer control, plus other allotments under
this section, for the fiscal year ending June 30,1967.
(4) (A) From each State's allotment under this subsection for
a fiscal year, the State shall be paid the Federal share of the
expenditures incurred during such year under its State plan ap-
proved under this subsection. Such payments shall be made from
time to time in advance on the basis of estimates by the Secretary
of the sums the State will expend under the State plan, except
that such adjustments as may be necessary shall be made on
account of previously made underpayments or overpayments un-
der this subsection.
(B) For the purpose of determining the Federal share for
any State, expenditures by nonprofit private agencies, organiza-
tions, and groups shall, subject to such limitations and condi-
tions as may be prescribed by regulations, be regarded as ex-
penditures by such State or a political subdivision thereof.
(5) The "Federal share" for any State for purposes of this
subsection shall be 100 per centum less than percentage which
bears the same ratio to 50 per centum as the per capita income
of such State bears to the per capital income of the United
States; except that in no case shall such percentage be less than
331/3 per centum or more than 66% per centum, and except that
the Federal share for the Commonwealth of Puerto Rico, Guam,
American Samoa, the Trust Territory of the Pacific Islands, and
the Virgin Islands shall be 66% per centum.
(6) The Federal shares shall be determined by the Secretary
between July 1 and September 1 of each year, on the basis of
the average per capita incomes of each of the States and of the
United States for the most recent year for which satisfactory
data are available from the Department of Commerce, and such
determination shall be conclusive for the fiscal year beginning on
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758 LEGAL COMPILATION—PESTICIDES
next July 1. The populations of the several States shall be deter-
mined on the basis of the latest figures for the population of the
several States available from the Department of Commerce.
(7) At least 15 per centum of a State's allotment under this
subsection shall be available only to the State mental health au-
thority for the provision under the State plan of mental health
services. Effective with respect to allotments under this subsec-
tion for fiscal years ending after June 30, 1968, at least 70 per
centum of such amount reserved for mental health services and
at least 70 per centum of the remainder of a State's allotment
under this subsection shall be available only for the provision
under the State plan of services in communities of the State.
Project grants for health services and related training; authorization of
appropriations; review of application by appropriate areawide health
planning agency
(e) There are authorized to be appropriated $90,000,000 for
the fiscal year ending June 30, 1968, $95,000,000 for the fiscal
year ending June 30, 1969, $80,000,000 for the fiscal year ending
June 30, 1970, $109,500,000 for the fiscal year ending June 30,
1971, $135,000,000 for the fiscal year ending June 30, 1972, and
$157,000,000 for the fiscal year ending June 30, 1973, for grants
to any public or nonprofit private agency, institution, or organiza-
tion to cover part of the cost (including equity requirements and
amortization of loans on facilities acquired from the Office of
Economic Opportunity or construction in connection with any pro-
gram or project transferred from the Office of Economic Op-
portunity) of (1) providing services (including related training)
to meet health needs of limited geographic scope or of specialized
regional or national significance, or (2) developing and support-
ing for an initial period new programs of health services (includ-
ing related training). Any grant made under this subsection may
be made only if the application for such grant has been referred
for review and comment to the appropriate areawide health
planning agency or agencies (or, if there is no such agency in
the area, then to such other public or nonprofit private agency
or organization (if any) which performs similar functions) and
only if the services assisted under such grant will be provided
in accordance with such plans as have been developed pursuant
to subsection (a) of this section.
Repeal
Subsec. (f) of this section repealed (less applicability
to commissioned officers of the Public Health Service) by
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STATUTES AND LEGISLATIVE HISTORY 759
Pub.L. 91-648, Title IV, §§ 403, 404, Jan. 5,1971, 84 Stat.
1925, effective sixty days after Jan. 5,1971.
Interchange of personnel with States
(f) (1) For the purposes of this subsection, the term "State"
means a State or a political subdivision of a State, or any agency
of either of the foregoing engaged in any activities related to
health or designated or established pursuant to subparagraph
(A) of paragraph (2) of subsection (a) of this section; the term
"Secretary" means (except when used in paragraph (3) (D) the
Secretary of Health, Education, and Welfare; and the term "De-
partment" means the Department of Health, Education, and
Welfare.
(2) The Secretary is authorized, through agreements or other-
wise, to arrange for assignment of officers and employees of States
to the Department and assignment to States of officers and em-
ployees in the Department engaged in work related to health, for
work which the Secretary determines will aid the Department in
more effective discharge of its responsibilities in the field of
health as authorized by law, including cooperation with States and
the provision of technical or other assistance. The period of as-
signment of any officer or employee under an arrangement shall
not exceed two years.
(3) (A) Officers and employees in the Department assigned
to any State pursuant to this subsection shall be considered, dur-
ing such assignment, to be (i) on detail to a regular work
assignment in the Department, or (ii) on leave without pay from
their positions in the Department.
(B) Persons considered to be so detailed shall remain as of-
ficers or employees, as the case may be, in the Department for
all purposes, except that the supervision of their duties during
the period of detail may be governed by agreement between the
Department and the State involved.
(C) In the case of persons so assigned and on leave without
pay—
(i) if the rate of compensation (including allowances)
for their employment by the State is less than the rate of
compensation (including allowances) they would be receiv-
ing had they continued in their regular assignment in the De-
partment, they may receive supplemental salary payments
from the Department in the amount considered by the Secre-
tary to be justified, but not at a rate in excess of the dif-
ference between the State rate and the Department rate; and
(ii) they may be granted annual leave and sick leave to
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760 LEGAL COMPILATION—PESTICIDES
the extent authorized by law, but only in circumstances con-
sidered by the Secretary to justify approval of such leave.
Such officers and employees on leave without pay shall, notwith-
standing any other provision of law, be entitled—
(iii) to continuation of their insurance under the Federal
Employees' Group Life Insurance Act of 1954, and coverage
under the Federal Employees Health Benefits Act of 1959,
so long as the Department continues to collect the employee's
contribution from the officer or employee involved and to
transmit for timely deposit into the funds created under such
Acts the amount of the employee's contributions and the
Government's contribution from appropriations of the De-
partment ; and
(iv) (I) in the case of commissioned officers of the Service,
to have their service during their assignment treated as pro-
vided in section 215 (d) of this title for such officers on leave
without pay, or (II) in the case of other officers and em-
ployees in the Department, to credit the period of their as-
signment under the arrangement under this subsection to-
ward periodic or longevity step increases and for retention
and leave accrual purposes, and, upon payment into the
civil service retirement and disability fund of the percentage
of their State salary, and of their supplemental salary pay-
ments, if any, which would have been deducted from a like
Federal salary for the period of such assignment and pay-
ment by the Secretary into such fund of the amount which
would have been payable by him during the period of such
assignment with respect to a like Federal salary, to treat
(notwithstanding the provisions of the Independent Offices
Appropriation Act, 1959, under the head "Civil Service Re-
tirement and Disability Fund") their service during such
period, as service within the meaning of the Civil Service
Retirement Act;
except that no officer or employee or his beneficiary may receive
any benefits under the Civil Service Retirement Act, the Federal
Employees Health Benefits Act of 1959, or the Federal Employees'
Group Life Insurance Act of 1954, based on service during an
assignment hereunder for which the officer or employee or (if he
dies without making such election) his beneficiary elects to receive
benefits, under any State retirement or insurance law or program,
which the Civil Service Commission determines to be similar. The
Department shall deposit currently in the funds created under
the Federal Employees' Group Life Insurance Act of 1954, the
Federal Employees Health Benefits Act of 1959, and the civil
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STATUTES AND LEGISLATIVE HISTORY 761
service retirement and disability fund, respectively, the amount
of the Government's contribution under these Acts on account of
service with respect to which employee contributions are collected
as provided in subparagraph (iii) and the amount of the Govern-
ment's contribution under the Civil Service Retirement Act on
account of service with respect to which payments (of the amount
which would have been deducted under that Act) referred to in
subparagraph (iv) are made to such civil service retirement
and disability fund.
(D) Any such officer or employee on leave without pay (other
than a commissioned officer of the Service) who suffers disability
or death as a result of personal injury sustained while in the
performance of his duty during an assignment hereunder, shall
be treated, for the purposes of the Federal Employees' Compensa-
tion Act, as though he were an employee, as defined in such Act,
who had sustained such injury in the performance of duty. When
such person (or his dependents, in case of death) entitled by
reason of injury or death to benefits under that Act is also entitled
to benefits from a State for the same injury or death, he (or his
dependents in case of death) shall elect which benefits he will
receive. Such election shall be made within one year after the
injury or death, or such further time as the Secretary of Labor
may for good cause allow, and when made shall be irrevocable
unless otherwise provided by law.
(4) Assignment of any officer or employee in the Department
to a State under this subsection may be made with or without
reimbursement by the State for the compensation (or supple-
mentary compensation), travel and transportation expenses (to
or from the place of assignment), and allowances, or any part
thereof, of such officer or employee during the period of assign-
ment, and any such reimbursement shall be credited to the ap-
propriation utilized for paying such compensation, travel or trans-
portation expenses, or allowances.
(5) Appropriations to the Department shall be available, in
accordance with the standardized Government travel regulations
or, with resnect to commissioned officers of the Service, the joint
travel regulations, for the expenses of travel of officers and em-
ployees assigned to States under an arrangement under this sub-
section on either a detail or leave-without-pay basis and, in ac-
cordance with applicable law, orders, and regulations, for ex-
penses of transportation of their immediate families and ex-
penses of transportation of their household goods and personal
effects, in connection with the travel of such officers and em-
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762 LEGAL COMPILATION—PESTICIDES
ployees to the location of their posts of assignment and their
return to their official stations.
(6) Officers and employees of States who are assigned to the
Department under an arrangement under this subsection may
(A) be given appointments in the Department covering the pe-
riods of such assignments, or (B) be considered to be on detail
to the Department. Appointments of persons so assigned may
be made without regard to the civil service laws. Persons so ap-
pointed in the Department shall be paid at rates of compensation
determined in accordance with the Classification Act of 1949, and
shall not be considered to be officers or employees of the Depart-
ment for the purposes of (A) the Civil Service Retirement Act,
(B) the Federal Employees' Group Life Insurance Act of 1954,
or (C) unless their appointments result in the loss of coverage
in a group health benefits plan whose premium has been paid
in whole or in part by a State contribution, the Federal Em-
ployees Health Benefits Act of 1959. State officers and employees
who are assigned to the Department without appointment shall
not be considered to be officers or employees of the Department,
except as provided in subsection (7), nor shall they be paid a
salary or wage by the Department during the period of their
assignment. The supervision of the duties of such persons dur-
ing the assignment may be governed by agreement between the
Secretary and the State involved.
(7) (A) Any State officer or employee who is assigned to the
Department without appointment shall nevertheless be subject to
the provisions of sections 203, 205, 207, 208, and 209 of Title 18.
(B) Any State officer or employee who is given an appointment
while assigned to the Department, or who is assigned to the De-
partment without appointment, under an arrangement under this
subsection, and who suffers disability or death as a result of per-
sonal injury sustained while in the performance of his duty dur-
ing such assignment shall be treated, for the purpose of the
Federal Employees' Compensation Act, as though he were an em-
ployee, as defined in such Act, who had sustained such injury in
the performance of duty. When such person (or his dependents,
in case of death) entitled by reason of injury or death to benefits
under that Act is also entitled to benefits from a State for the
same injury or death, he (or his dependents, in case of death)
shall elect which benefits he will receive. Such election shall be
made within one year after the injury or death, or such further
time as the Secretary of Labor may for good cause allow, and
when made shall be irrevocable unless otherwise provided by law.
(8) The appropriations to the Department shall be available, in
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STATUTES AND LEGISLATIVE HISTORY 763
accordance with the standardized Government travel regulations,
during the period of assignment and in the case of travel to and
from their places of assignmnt or appointment, for the payment
of expenses of travel of persons assigned to, or given appoint-
ments by, the Department under an arragement under this sub-
section.
(9) All arrangements under this subsection for assignment of
officers or employees in the Department to States or for assign-
ment of officers or employees of States to the Department shall be
made in accordance with regulations of the Secretary.
Consultation with State authorities; failure to comply with statute or rules
and regulations; definitions
(g) (1) All regulations and amendments thereto with respect
to grants to States under subsection (a) of this section shall
be made after consultation with a conference of the State health
planning agencies designated or established pursuant to subpara-
graph (A) of paragraph (2) of subsection (a) of this section.
All regulations and amendments thereto with respect to grants
to States under subsection (d) of this section shall be made
after consultation with a conference of State health authorities
and, in the case of regulations and amendments which relate to
or in any way affect grants for services or other activities in the
field of mental health, the State mental health authorities. Insofar
as practicable, the Secretary shall obtain the agreement, prior
to the issuance of such regulations or amendments, of the State
authorities or agencies with whom such consultation is required.
(2) The Secretary, at the request of any recipient of a grant
under this section, may reduce the payments to such recipient
by the fair market value of any equipment or supplies furnished
to such recipient and by the amount of the pay, allowances,
traveling expenses, and any other costs in connection with the
detail of an officer or employee to the recipient when such fur-
nishing or such detail, as the case may be, is for the convenience
of and at the request of such recipient and for the purpose of
carrying out the State plan or the project with respect to which
the grant under this section is made. The amount by which such
payments are so reduced shall be available for payment of such
costs (including the costs of such equipment and supplies) by the
Secretary, but shall, for purposes of determining the Federal share
under subsection (a) or (d) of this section, be deemed to have
been paid to the State.
(3) Whenever the Secretary, after reasonable notice and op-
portunity for hearing to the health authority or, where appro-
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764 LEGAL COMPILATION—PESTICIDES
priate, the mental health authority of a State or a State health
planning agency designated or established pursuant to subpara-
graph (A) of paragraph (2) of subsection (a) of this section,
finds that, with respect to money paid to the State out of ap-
propriations under subsection (a) or (d) of this section, there
is a failure to comply substantially with either—
(A) the applicable provisions of this section;
(B) the State plan submitted under such subsection; or
(C) applicable regulations under this section;
the Secretary shall notify such State health authority, mental
health authority, or health planning agency, as the case may be,
that further payments will not be made to the State from ap-
propriations under such subsection (or in his discretion that fur-
ther payments will not be made to the State from such ap-
propriations for activities in which there is such failure), until
he is satisfied that there will no longer be such failure. Until he
is so satisfied, the Secretary shall make no payment to such State
from appropriations under such subsection, or shall limit payment
to activities in which there is no such failure.
(4) For the purposes of this section—
(A) The term "nonprofit" as applied to any private agen-
cy, institution, or organization means one which is a corpora-
tion or association, or is owned and operated by one or more
corporations or associations, no part of the net earnings of
which inures, or may lawfully inure, to the benefit of any
private shareholder or individual; and
(B) The term "State" includes the Commonwealth of
Puerto Rico, Guam, American Samoa, the Trust Territory
of the Pacific Islands, the Virgin Islands, and the District
of Columbia and the term "United States" means the fifty
States and the District of Columbia.
July 1, 1944, c. 373, Title III, § 314, 58 Stat. 693; July 3, 1946, c.
538, § 9, 60 Stat, 424; June 16, 1948, c. 481, § 5, 62 Stat. 468;
1953 Reorg. Plan No. 1, § § 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053,
67 Stat. 631; Aug. 1, 1956, c. 852, § 18, 70 Stat. 910; July 22,
1958, Pub.L. 85-544, § 1, 72 Stat. 400; Oct. 5, 1961, Pub.L. 87-395,
§ 2(a)-(d), 75 Stat. 824; Sept. 25, 1962, Pub.L. 87-688, § 4 (a)
(1), 76 Stat. 587; Aug. 5, 1965, Pub.L. 89-109, § 4, 79 Stat. 436;
Nov. 3, 1966, Pub.L. 89-749, § 3, 80 Stat. 1181; Dec. 5, 1967,
Pub.L. 90-174, § § 2 (a) - (f), 3 (b) (2), 8 (a), (b), 12 (d), 81 Stat.
533-535, 540, 541; June 30, 1970, Pub.L. 91-296, Title I, § 111 (b),
Title IV, 401 (b) (1) (C), (D), 84 Stat. 340, 352; Oct. 27,
1970, Pub.L. 91-513, Title I, § 3(b), 84 Stat. 1241; Oct. 30, 1970,
Pub.L. 91-515, Title II, § § 220, 230, 240, 250,'260(a), (b), (c)
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STATUTES AND LEGISLATIVE HISTORY 765
(1), 282, 84 Stat. 1304-1306, 1308; and amended Dec. 31, 1970,
Pub.L. 91-616, Title III, § 331, 84 Stat. 1853.
Part G.—Quarantine and Inspection
§ 264. Regulations to control communicable diseases; apprehen-
sion, detention, and release of certain persons from particular
places
(a) The Surgeon General, with the approval of the Secretary,
is authorized to make and enforce such regulations as in his
judgment are necessary to prevent the introduction, transmission,
or spread of communicable diseases for foreign countries into the
States, or possessions, or from one State or possession into any
other State or possession. For purposes of carrying out and enforc-
ing such regulations, the Surgeon General may provide for such in-
spection, fumigation, disinfection, sanitation, pest extermination,
destruction of animals or articles found to be so infected or
contaminated as to be sources of dangerous infection to human
beings, and other measures, as in his judgment may be necessary.
(b) Regulations prescribed under this section shall not pro-
vide for the apprehension, detention, or conditional release of
individuals except for the purpose of preventing the introduction,
transmission, or spread of such communicable diseases as may
be specified from time to time in Executive orders of the Presi-
dent upon the recommendation of the National Advisory Health
Council and the Surgeon General.
(c) Except as provided in subsection (d) of this section, regu-
lations prescribed under this section, insofar as they provide for
the apprehension, detention, examination, or conditional release
of individuals, shall be applicable only to individuals coming into
a State or possession from a foreign country or a possession.
(d) On recommendation of the National Advisory Health Coun-
cil, regulations prescribed under this section may provide for
the apprehension and examination of any individual reasonably
believed to be infected with a communicable disease in a com-
municable stage and (1) to be moving or about to move from a
State to another State; or (2) to be a probable source of infection
to individuals who, while infected with such disease in a com-
municable stage, will be moving from a State to another State.
Such regulations may provide that if upon examination any such
individual is found to be infected, he may be detained for such time
and in such manner as may be reasonably necessary.
July 1, 1944, c. 373, Title III, § 361, 58 Stat. 703; 1953 Reorg.
Plan No. 1, § § 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat.
631; July 12,1960, Pub.L. 86-624, § 29 (c), 74 Stat. 419.
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766 LEGAL COMPILATION—PESTICIDES
1.5 ENVIRONMENTAL QUALITY BRANCH OF THE PLANT
PROTECTION DIVISION
1.5a THE ORGANIC ACT OF 1862, AS AMENDED
7 U.S.C. §§2201-2212 (1967)
§ 2201. Establishment of Department
There shall be at the seat of government a Department of Agri-
culture, the general design and duties of which shall be to acquire
and to diffuse among the people of the United States useful infor-
mation on subjects connected with agriculture, in the most general
and comprehensive sense of the word, and to procure, propagate,
and distribute among the people new and valuable seeds and plants.
R.S. § 520.
§ 2202. Executive Department; Secretary
The Department of Agriculture shall be an executive depart-
ment, under the supervision and control of a Secretary of Agricul-
ture, who shall be appointed by the President, by and with the
advice and consent of the Senate. The provisions of title IV of the
Revised Statutes, including all amendments thereto, shall be applic-
able to said department; and all laws and parts of laws relating to
the Department of Agriculture in existence February 9, 1889, as
far as the same are applicable and not in conflict with said sections,
and only so far, are continued in full force and effect.
Feb. 9,1889, c. 122, §§ 1, 4, 25 Stat. 659.
§ 2203. Seal
The Secretary of Agriculture is authorized and directed to pro-
cure a proper seal, with such suitable inscriptions and devices as
he may approve, to be known as the official seal of the Department
of Agriculture, and to be kept and used to verify official documents,
under such rules and regulations as he may prescribe.
Aug. 8,1894, c. 238, 28 Stat. 272.
§ 2204. General duties of Secretary
The Secretary of Agriculture shall procure and preserve all
information concerning agriculture which he can obtain by means
of books and correspondence, and by practical and scientific experi-
ments, accurate records of which experiments shall be kept in his
office, by the collection of statistics, and by any other appropriate
means within his power; he shall collect new and valuable seeds
and plants; shall test, by cultivation, the value of such of them as
may require such tests; shall propagate such as may be worthy of
propagation; and shall distribute them among agriculturists.
R.S. § 526.
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STATUTES AND LEGISLATIVE HISTORY 767
§ 2205. Duties of former Commissioner of Agriculture trans-
ferred to Secretary
The Secretary of Agriculture is authorized and directed to per-
form all the duties named in all Acts of Congress in force on
February 8, 1889, to be performed by the Commissioner of
Agriculture.
Mar. 2,1889, c. 373, 25 Stat. 840; July 14,1890, c. 707, 26 Stat. 288.
§ 2206. Custody of property and records
The Secretary of Agriculture shall have charge, in the building
and premises appropriated to the department, of the library,
furniture, fixtures, records, and other property appertaining to it,
or acquired for use in its business.
R.S. § 525.
§ 2207. Reports
The Secretary of Agriculture shall annually make a general
report in writing of his acts to the President, in which he may
recommend the publication of papers forming parts of or accom-
panying his report. He shall also make special reports on particu-
lar subjects whenever required to do so by the President or either
House of Congress, or when he shall think the subject in his charge
requires it.
R.S. §§ 528, 529; May 29, 1928, c. 901, § 1, 45 Stat. 993; Aug. 30,
1954, c. 1076, § 1 (6), 68 Stat. 966.
§ 2208. Same; expenditure of appropriations; accounting
The Secretary of Agriculture shall direct and superintend the
expenditure of all money appropriated to the Department and
render accounts thereof.
R.S. § 3677; Feb. 9,1889, c. 122, §§ 1, 4, 25 Stat. 659.
§ 2209. Same; additional statement of expenditures
The Secretary of Agriculture shall furnish proper vouchers and
accounts for the sums appropriated for the Department of Agri-
culture to the General Accounting Office.
Mar. 3, 1885, c. 338, § 2, 23 Stat. 356; Aug. 11, 1916, c. 313, 39 Stat.
492; June 10, 1921, c. 18, § 301, 42 Stat. 23; May 29, 1928, c. 901,
§ 1, 45 Stat. 992.
§ 2210. Under Secretary of Agriculture; appointment
There is established in the Department of Agriculture the posi-
tion of Under Secretary of Agriculture, to be appointed by the
President, by and with the advice and consent of the Senate.
Mar. 26, 1934, c. 89, Title I, 48 Stat. 467; Oct. 15, 1949, c. 695, $ 3,
63 Stat. 880; July 31, 1956, c. 804, Title I, $ 104(a), 70 Stat. 736.
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768 LEGAL COMPILATION—PESTICIDES
§ 2211. Same; duties
The Under Secretary of Agriculture is authorized to exercise the
functions and perform the duties of the first assistant of the
Secretary of Agriculture within the meaning of section 3345 of
Title 5 and shall perform such other duties as may be required by
law or prescribed by the Secretary of Agriculture.
June 5,1939, c. 181, 53 Stat. 809.
§ 2212. Assistant Secretary
There shall be in the Department of Agriculture an Assistant
Secretary of Agriculture, to be appointed by the President, by and
with the advice and consent of the Senate, who shall perform such
duties as may be required by law or prescribed by the Secretary.
The Assistant Secretary of Agriculture is authorized to perform
such duties in the conduct of the business of the Department of
Agriculture as may be assigned by the Secretary of Agriculture.
Feb. 9, 1889, c. 122, § 2, 25 Stat. 659; June 30, 1906, c. 3913, 34
Stat. 670.
1.5b THE PRESIDENT'S SCIENCE ADVISORY COMMITTEE
REPORT ON PESTICIDES, MAY 14, 1963, p. 22
THE WHITE HOUSE
This report on the use of pesticides has been prepared for me
by my Science Advisory Committee.
I have already requested the responsible agencies to implement
the recommendations in the report, including the preparation of
legislative and technical proposals which I shall submit to the
Congress.
Because of its general public interest, I am releasing the report
for publication.
JOHN F. KENNEDY.
THE WHITE HOUSE,
May 14,1963.
*******
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. 20]
a. Selectively toxic chemicals
b. Non-persistent chemicals
c. Selective methods of application
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STATUTES AND LEGISLATIVE HISTORY 769
d. Non-chemical control methods such as the use of attract-
ants 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
research 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 neeeded in the search for selective methods of pesticide
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 extrapolation 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
animals, 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 com-
monly used pesticides with such commonly used drugs as seda-
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770 LEGAL COMPILATION — PESTICIDES
tives, tranquilizers, analgesics, antihypertensive agents and
steroid hormones, which are administered over prolonged
periods.
[p
3. Toxicity Studies Related to Wildlife
The Panel recommends expanded research and evaluation by the
Department of the Interior of the toxic effects of pesticides on wild
vertebrates and invertebrates.
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 personnel could be ensured by a system of
grants and contracts. Training grants, basic research grants, and
contracts to universities 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 immediate 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
registration 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.
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STATUTES AND LEGISLATIVE HISTORY 771
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
participate in the control programs, but funds have not been
available except by diversion from other essential agency functions.
[p. 22]
1.5c AGRICULTURAL RESEARCH SERVICE, DEPARTMENT
OF AGRICULTURE AND RELATED AGENCD3S APPROPRI-
ATION ACT OF 1965
September 2, 1965, P.L. 88-573, Title I, 78 Stat. 862
DEPARTMENT OF AGRICULTURE AND RELATED
AGENCIES APPROPRIATION ACT, 1965
PUBLIC LAW 88-573; 78 STAT. 862
[H.R. 11202]
AN ACT making appropriations for the Department of Agriculture and
related agencies for the fiscal year ending June 30, 1965, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, That:
The following sums are appropriated, out of any money in the
Treasury not otherwise appropriated, for the Department of Agri-
culture and related agencies for the fiscal year ending June 30,
1965, and for other purposes: namely:
DEPARTMENT OF AGRICULTURE
TITLE I—GENERAL ACTIVITIES
AGRICULTURAL RESEARCH SERVICE
Salaries and Expenses
For expenses necessary to perform agricultural research relat-
ing to production, utilization, marketing, nutrition and consumer
use, to control and eradicate pests and plant and animal diseases,
and to perform related inspection, quarantine and regulatory work,
and meat inspection: Provided, That appropriations hereunder
shall be available for field employment pursuant to the second
sentence of section 706(a) of the Organic Act of 1944 (5 U.S.C.
574), and not to exceed $75,000 shall be available for employment
under section 15 of the Act of August 2, 1946 (5 U.S.C. 55a) :
Provided further, That appropriations hereunder shall be available
for the operation and maintenance of aircraft and the purchase of
not to exceed two for replacement only: Provided further, That
appropriations hereunder shall be available pursuant to title 5,
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772 LEGAL COMPILATION—PESTICIDES
United States Code, section 565a, for the construction, alteration,
and repair of buildings and improvements, but unless otherwise
provided, the cost of constructing any one building (except head-
houses connecting greenhouses) shall not exceed $20,000, except
for six buildings to be constructed or improved at a cost not to
exceed $45,000 each, and the cost of altering any one building dur-
ing the fiscal year shall not exceed $7,500 or 7.5 per centum of the
cost of the building, whichever is greater: Provided further, That
the limitations on alterations contained in this Act shall not apply
to a total of $100,000 for facilities at Beltsville, Maryland:
Research: For research and demonstrations on the production
and utilization of agricultural products; agricultural marketing
and distribution, not otherwise provided for; home economics or
nutrition and consumer use of agricultural and associated prod-
ucts ; and related research and services; and for acquisition of land
by donation, exchange, or purchase at a nominal cost not to exceed
$100, $114,991,000, plus not to exceed the following amounts, to
remain available until expended, for the planning, construction,
alteration, and equipping of research facilities; $1,000,000 for
crops research facilities at Fort Collins, Colorado; $850,000 for
facilities at the Agricultural Research Center, Beltsville, Mary-
land ; $800,000 for a stored-products insects laboratory, Savannah,
Georgia; $260,000 for plans for a livestock insects and toxicology
laboratory, College Station, Texas; $338,000 for plans for a plant
disease, nematode, and insect laboratory, Beltsville, Maryland;
$160,000 for plans for an insect attractants and stored-product
insects laboratory, Gainesville, Florida; $1,000,000 for a peanut
quality research laboratory, at Dawson, Georgia, on a site acquired
by donation; and $240,000 for plans for a Western cotton insects
and physiology laboratory, Tempe, Arizona; a cotton disease labo-
[p. 986]
ratory, College Station, Texas; a cotton physiology laboratory,
Stoneville, Mississippi; pilot cotton ginning facilities at Stoneville,
Mississippi, and Mesilla Park, New Mexico; and facilities in the
High Plains region in Texas for cotton ginning and storage
research; in all, $119,639,000: Provided, That the limitations con-
tained herein shall not apply to replacement of buildings needed
to carry out the Act of April 24, 1948 (21 U.S.C. 113(a)) ;
Plant and animal disease and pest control: For operations and
measures, not otherwise provided for, to control and eradicate
pests and plant and animal diseases and for carrying out assigned
inspection, quarantine, and regulatory activities, as authorized by
law, including expenses pursuant to the Act of February 28, 1947,
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STATUTES AND LEGISLATIVE HISTORY 773
as amended (21 U.S.C. 114b-c), $68,793,200, of which $1,500,000
shall be apportioned for use pursuant to section 3679 of the
Revised Statutes, as amended, for the control of outbreaks of
insects and plant diseases to the extent necessary to meet emer-
gency conditions: Provided, That no funds shall be used to formu-
late or administer a brucellosis eradication program for the cur-
rent fiscal year that does not require minimum matching by any
State of at least 40 per centum: Provided further, That no funds
in excess of $250,000 shall be available for carrying out the
screwworm eradication program that does not require minimum
matching by State or local sources of at least 50 per centum of the
expenses of production, irradiation, and release of the screwworm
flies: Provided further, That, in addition, in emergencies which
threaten the livestock or poultry industries of the country, the
Secretary may transfer from other appropriations or funds avail-
able to the agencies or corporations of the Department such sums
as he may deem necessary, to be available only in such emergen-
cies for the arrest and eradication of foot-and-mouth disease,
rinderpest, contagious pleuropneumonia, or other contagious or
infectious diseases of animals, or European fowl pest and similar
diseases in poultry, and for expenses in accordance with the Act of
February 28, 1947, as amended, and any unexpended balances of
funds transferred under this head in the next preceding fiscal year
shall be merged with such transferred amounts;
Meat inspection: For carrying out the provisions of laws relat-
ing to Federal inspection of meat, and meat-food products, and the
applicable provisions of the laws relating to process or renovated
butter, $30,837,000;
Special fund: To provide for additional labor to be employed
under contracts and cooperative agreements to strengthen the
work at research installations in the field, not more than $1,000,000
of the amount appropriated under this head for the previous fiscal
year may be used by the Administrator of the Agricultural
Research Service in departmental research programs in the cur-
rent fiscal year, the amount so used to be transferred to and merged
with the appropriation otherwise available under "Salaries and
expenses, Research".
Salaries and Expenses (Special Foreign Currency Program)
For payments in foreign currencies which accrue under title I
of the Agricultural Trade Development and Assistance Act of
1954, as amended (7 U.S.C. 1704), for market development
research authorized by section 104 (a) and for agricultural and
forestry research and other functions related thereto authorized by
-------
774 LEGAL COMPILATION—PESTICIDES
section 104 (k) of the Agricultural Trade Development and Assist-
ance Act of 1954, as amended (7 U.S.C. 1704 (a) (k)), to remain
available until expended, $2,000,000: Provided, That this appro-
priation shall be available in addition to other appropriations for
these purposes, for payments in the foregoing currencies: Provided
further, That funds appropriated herein shall be used for payments
in such foreign currencies as the Department determines are need-
ed and can be used most effectively to carry out the purposes of this
paragraph, and such foreign currencies shall, pursuant to the pro-
visions of section 104 (a), be set aside for sale to the Department
before foreign currencies which accrue under said title I are made
available for other United States uses: Provided further, That not
to exceed $25,000 of this appropriation shall be available for
payments in foreign currencies for
[p. 987]
1.6 SPECIAL PACKAGING OF HOUSEHOLD SUBSTANCES
FOR PROTECTION OF CHILDREN
15 U.S.C. §1471 et seg. (1970)
Sec.
1471. Definitions.
1472. Special packaging standards.
(a) Establishment.
(b) Considerations.
(c) Publication of findings, reasons, and citation of statutory
authorizations.
(d) Limitation.
1473. Conventional packages, marketing.
(a) Noncomplying packages for elderly or handicapped persons;
labeling statements.
(b) Noncomplying packages for substances dispensed pursuant to
orders of medical practitions.
(c) Exclusive use of special packaging; necessary circumstances.
1474. Regulations for special packaging standards.
(a) Rule making procedure; election and application of procedure
tinder section 371 of Title 21; publication of election proposal.
(b) Judicial review; petition; record; additional evidence; jurisdic-
tion of court of appeals; scope of review; relief pending review;
finality of judgment; review by Supreme Court.
1475. Technical advisory committee.
(a) Appointment; designation of chairman; representation of in-
terests; consultation of Secretary with committee.
(b) Compensation and travel expenses.
1476. Federal preemption.
§ 1471. Definitions
For the purpose of this Act—
(1) The term "Secretary" means the Secretary of Health, Edu-
cation, and Welfare.
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STATUTES AND LEGISLATIVE HISTORY 775
(2) The term "household substance" means any substance
which is customarily produced or distributed for sale for consump-
tion or use, or customarily stored, by individuals in or about the
household and which is—
(A) a hazardous substance as that term is denned in sec-
tion 1261 (f) of this title;
(B) a pesticide as that term is defined in section 135 (a)
of Title 7;
(C) a food, drug, or cosmetic as those terms are denned
section 321 of Title 21; or
(D) a substance intended for use as fuel when stored in a
portable container and used in the heating, cooking, or refrig-
eration system of a house.
(3) The term "package" means the immediate container or
wrapping in which any household substance is contained for con-
sumption, use, or storage by individuals in or about the household,
and, for purposes of section 1473 (a) (2) of this title, also means
any outer container or wrapping used in the retail display of any
such substance to consumers. Such term does not include—
(A) any shipping container or wrapping used solely for
the transportation of any household substance in bulk or in
quantity to manufacturers, packers, or processors, or to
wholesale or retail distributors thereof, or
(B) any shipping container or outer wrapping used by
retailers to ship or deliver any household substance to con-
sumers unless it is the only such container or wrapping.
(4) The term "special packaging" means packaging that is de-
signed or constructed to be significantly difficult for children under
five years of age to open or obtain a toxic or harmful amount of
the substance contained therein within & reasonable time and not
difficult for normal adults to use properly, but does not mean
packaging which all such children cannot open or obtain a toxic
or harmful amount within a reasonable time.
(5) The term "labeling" means all labels and other written,
printed, or graphic matter (A) upon any household substance or
its package, or (B) accompanying such substance.
Pub.L. 90-601, § 2, Dec. 30, 1970, 84 Stat. 1670.
§ 1472. Special packaging standards—Establishment
(a) The Secretary, after consultation with the technical advi-
sory committee provided for in section 1475 of this title, may
establish in accordance with the provisions of this Act, by regu-
lation, standards for the special packaging of any household sub-
stance if he finds that—
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776 LEGAL COMPILATION—PESTICIDES
(1) the degree or nature of the hazard to children in the
availability of such substance, by reason of its packaging, is
such that special packaging is required to protect children
from serious personal injury or serious illness resulting from
handling, using, or ingesting such substance; and
(2) the special packaging to be required by such standard
is technically feasible, practicable, and appropriate for such
substance.
Considerations
(b) In establishing a standard under this section, the Secretary
shall consider—
(1) the reasonableness of such standard;
(2) available scientific, medical, and engineering data con-
cerning special packaging and concerning childhood accidental
ingestions, illness, and injury caused by household substances;
(3) the manufacturing practices of industries affected by
this Act; and
(4) the nature and use of the household substance.
Publication of findings, reasons, and citation of statutory authorizations
(c) In carrying out this Act, the Secretary shall publish his
findings, his reasons therefor, and citation of the sections of stat-
utes which authorize his action.
Limitation
(d) Nothing in this Act shall authorize the Secretary to pre-
scribe specific packaging designs, product content, package quan-
ity, or, with the exception of authority granted in section 1473 (a)
(2) of this title, labeling. In the case of a household substance for
which special packaging is required pursuant to a regulation un-
der this section, the Secretary may in such regulation prohibit the
packaging of such substance in packages which he determines are
unnecessarily attractive to children.
Pub.L. 91-601, § 3, Dec. 30, 1970, 84 Stat. 1670.
§ 1473. Conventional packages, marketing—Noncomplying pack-
ages for elderly or handicapped persons; labeling statements
(a) For the purpose of making any household substance which
is subject to a standard established under section 1472 of this title
readily available to elderly or handicapped persons unable to use
such substance when packaged in compliance with such standard,
the manufacturer or packer, as the case may be, may package
any household substance, subject to such a standard, in packag-
ing of a single size which does not comply with such standard if—
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STATUTES AND LEGISLATIVE HISTORY 777
(1) the manufacturer (or packer) also supplies such sub-
stance in packages which comply with such standard; and
(2) the packages of such substance which do not meet
such standard bear conspicuous labeling stating; "This pack-
age for households without young children"; except that the
Secretary may be regulation prescribe a substitute statement
to the same effect for packaging too small to accommodate
such labeling.
Noncomplying packages for substances dispensed pursuant to orders of
medical practitioners
(b) In the case of a household substance which is subject to
such a standard and which is dispensed pursuant to an order of a
physician, dentist, or other licensed medical practitioner author-
ized to perscribe, such substance may be dispensed in noncomply-
ing packages only when directed in such order or when requested
by the purchaser.
Exclusive use of special packaging; necessary circumstances
(c) In the case of a household substance subject to such a
standard which is packaged under subsection (a) of this section
in a noncomplying package, if the Secretary determines that such
substance is not also being supplied by a manufacturer (or pack-
er) in popular size packages which comply with such standard, he
may, after giving the manufacturer (or packer) an opportunity
to comply with the purposes of this Act, by order require such
substance to be packaged by such manufacturer (or packer) ex-
clusively in special packaging complying with such standard if he
finds, after opportunity for hearing, that such exclusive use of
special packaging is necessary to accomplish the purposes of this
Act.
Pub.L. 91-601, § 4, Dec. 30,1970, 84 Stat. 1671.
§ 1474. Regulations for special packaging standards—Rule mak-
ing procedure; election and application of procedure under section
371 of Title 21; publication of election and proposal
(a) Proceedings to issue, amend, or repeal a regulation pre-
scribing a standard under section 1472 of this title shall be con-
ducted in accordance with the procedures prescribed by section
553 (other than paragraph (3) (B) of the last sentence of sub-
section (b) of such section) of Title 5 unless the Secretary elects
the procedures prescribed by subsection (e) of section 371 of Title
21, in which event such subsection and subsections (f) and (g) of
such section 371 shall apply to such proceedings. If the Secretary
makes such election, he shall publish that fact with the proposal
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778 LEGAL COMPILATION—PESTICIDES
required to be published under paragraph (1) of such subsection
(e).
Judicial review; petition; record; additional evidence; jurisdiction of court of
appeals; scope of review; relief pending review; finality of judgment;
review by Supreme Court
(b) (1) In the case of any standard prescribed by a regulation
issued in accordance with section 553 of Title 5, any person who
will be adversely affected by such a standard may, at any time
prior to the 60th day after the regulation prescribing such stand-
ard is issued by the Secretary, file a petition with the United
States Court of Appeals for the circuit in which such person re-
sides or has his principal place of business for a judicial review
of such standard. A copy of the petition shall be forthwith trans-
mitted by the clerk of the court to the Secretary or other officer
designated by him for that purpose. The Secretary shall file in the
court the record of the proceedings on which the Secretary based
his standard, as provided in section 2112 of Title 28.
(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 was no oppor-
tunity to adduce such evidence in the proceeding before the Sec-
retary, the court may order such additional evidence (and evi-
dence in rebuttal thereof) to be taken before the Secretary in a
hearing or in such other manner, and upon such terms and con-
ditions, 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, for the modifica-
tion or setting aside of his original standard, with the return of
such additional evidence.
(3) Upon the filing of the petition under paragraph (1) of this
subsection the court shall have jurisdiction to review the standard
of the Secretary in accordance with subparagraphs (A), (B),
(C), and (D) of paragraph (2) of section 706 of Title 5. If the
court ordered additional evidence to be taken under paragraph
(2) of this subsection, the court shall also review the Secretary's
standard to determine if, on the basis of the entire record before
the court pursuant to paragraphs (1) and (2) of this subsection,
it is supported by substantial evidence. If the court finds the
standard is not so supported, the court may set it aside.
(4) With respect to any standard reviewed under this subsec-
tion, the court may grant appropriate relief pending conclusion of
the review proceedings, as provided in section 705 of such Title 5.
-------
STATUTES AND LEGISLATIVE HISTORY 779
(5) The judgment of the court affirming or setting aside, in
whole or in part, any such standard of the Secretary shall be final,
subject to review by the Supreme Court of the United States upon
certiorari or certification, as provided in section 1254 of Title 28.
Pub.L. 91-601, § 5, Dec. 30, 1970, 84 Stat. 1671.
§ 1475. Technical advisory committee—Appointment; designa-
tion of chairman; representation of interests; consultation of Sec-
retary with committee
(a) For the purpose of assisting in carrying out the purposes
of this Act, the Secretary shall appoint a technical advisory com-
mittee, designating a member thereof to be chairman, composed
of not more than eighteen members who are representative of (1)
the Department of Health, Education, and Welfare, (2) the De-
partment of Commerce, (3) manufacturers of household sub-
stances subject to this Act, (4) scientists with expertise related
to this Act and licensed practitioners in the medical field, (5) con-
sumers, and (6) manufacturers of packages and closures for
household substances. The Secretary shall consult with the techni-
cal advisory committee in making findings and in establishing
standards pursuant to this Act.
Compensation and travel expenses
(b) Members of the technical advisory committee who are not
regular full-time employees of the United States shall, while at-
tending meetings of such committee, be entitled to receive com-
pensation at a rate fixed by the Secretary, but not exceeding $100
per diem, including traveltime, and while so serving away from
their homes or regular places of business, they may be allowed
travel expenses, including per diem in lieu of subsistence, as
authorized by section 5703 of Title 5 for persons in the Govern-
ment service employed intermittently.
Pub.L. 91-601, § 6, Dec. 30, 1970, 84 Stat. 1672.
§ 1476. Federal preemption
Whenever a standard established by the Secretary under this
Act applicable to a household substance is in effect no State or
political subdivision thereof shall have any authority either to
establish or continue in effect, with respect to such household sub-
stance, any standard for special packaging (and any exemption
therefrom and requirement related thereto) which is not identical
to the standard established under section 1472 of this title (and any
exemption therefrom and requirement related thereto) of this Act.
Pub.L. 91-601, § 8, Dec. 30,1970, 84 Stat. 1673.
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780 LEGAL COMPILATION—PESTICIDES
1.6a POISON PREVENTION PACKAGING ACT OF 1970
December 30, 1970, P.L. 91-601, 84 Stat. 1670
AN ACT
To provide for special packaging to protect children from serious personal
injury or serious illness resulting from handling, using or ingesting house-
hold substances, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled.
SECTION 1. This Act may be cited as the "Poison Prevention
Packaging Act of 1970".
SEC. 2. For the purpose of this Act—
(1) The term "Secretary" means the Secretary of Health,
Education, and Welfare.
(2) The term "household substance" means any substance
which is customarily produced or distributed for sale for consump-
tion or use, or customarily stored, by individuals in or about the
household and which is—
(A) a hazardous substance as that term is defined in
section 2(f) of the Federal Hazardous Substances Act (15
U.S.C. 1261 (f)) ;
(B) an economic poison as that term is defined in section
2a of the Federal Insecticide, Fungicide, and Rodenticide Act
(7 U.S.C. 135(a)) ;
(C) a food, drug, or cosmetic as those terms are defined in
section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321) ;or
(D) a substance intended for use as fuel when stored in a
portable container and used in the heating, cooking, or
refrigeration system of a house.
(3) The term "package" means the immediate container or
wrapping in which any household substance is contained for con-
sumption, use, or storage by individuals in or about the household,
and, for purposes of section 4(a)(2) of this Act, also means any
outer container or wrapping used in the retail display of any such
substance to consumers. Such term does not include—
(A) any shipping container or wrapping used solely for
the transportation of any household substance in bulk or in
quantity to manufacturers, packers, or processors, or to
wholesale or retail distributors thereof, or
(B) any shipping container or outer wrapping used by
retailers to ship or deliver any household substance to con-
sumers unless it is the only such container or wrapping.
-------
STATUTES AND LEGISLATIVE HISTORY 781
(4) The term "special packaging" means packaging that is
designed or constructed to be significantly difficult for children
under five years of age to open or obtain a toxic or harmful amount
of the substance contained therein within a reasonable time and
not difficult for normal adults to use properly, but does not mean
packaging which all such children cannot open or obtain a toxic
or harmful amount within a reasonable time.
(5) The term "labeling" means all labels and other written,
printed, or graphic matter (A) upon any household substance or
its package, or (B) accompanying such substance.
SEC. 3. (a) The Secretary, after consultation with the technical
advisory committee provided for in section 6 of this Act, may estab-
lish in accordance with the provisions of this Act, by regulation,
standards for the special packaging of any household substance if
he finds that—
(1) the degree or nature of the hazard to children in the
availability of such substance, by reason of its packaging, is
such that special packaging is required to protect children
[p. 1670]
from serious personal injury or illness resulting from han-
dling, using, or ingesting such substance; and
(2) the special packaging to be required by such standard
is technically feasible, practicable, and appropriate for such
substance.
(b) In establishing a standard under this section, the Secretary
shall consider—
(1) the reasonableness of such standard ;
(2) available scientific, medical, and engineering data con-
cerning special packaging and concerning childhood accidental
ingestions, illness, and injury caused by household substances;
(3) the manufacturing practices of industries affected by
this Act; and
(4) the nature and use of the household substance.
(c) In carrying out this Act, the Secretary shall publish his
findings, his reasons therefor, and citation of the sections of stat-
utes which authorize his action.
(d) Nothing in this Act shall authorize the Secretary to pre-
scribe specific packaging designs, product content, package quan-
tity, or, with the exception of authority granted in section 4 (a) (2)
of this Act, labeling. In the case of a household substance for which
special packaging is required pursuant to a regulation under this
section, the Secretary may in such regulation prohibit the packag-
-------
782 LEGAL COMPILATION—PESTICIDES
ing of such substance in packages which he determines are
unnecessarily attractive to children.
SEC. 4. (a) For the purpose of making any household sub-
stance which is subject to a standard established under section 3
readily available to elderly or handicapped persons unable to use
such substance when packaged in compliance with such standard,
the manufacturer or packer, as the case may be, may package any
household substance, subject to such a standard, in packaging of a
single size which does not comply with such standard if—
(1) the manufacturer (or packer) also supplies such sub-
stance in packages which comply with such standard; and
(2) the packages of such substance which do not meet such
standard bear conspicuous labeling stating: "This package for
households without young children"; except that the Secretary
may by regulation prescribe a substitute statement to the same
effect for packaging too small to accommodate such labeling.
(b) In the case of a household substance which is subject to
such a standard and which is dispensed pursuant to an order of a
physician, dentist, or other licensed medical practitioner author-
ized to prescribe, such substance may be dispensed in noncomply-
ing packages only when directed in such order or when requested
by the purchaser.
(c) In the case of a household substance subject to such a
standard which is packaged under subsection (a) in a noncomply-
ing package, if the Secretary determines that such substance is
not also being supplied by a manufacturer (or packer) in popular
size packages which comply with such standard, he may, after
giving the manufacturer (or packer) an opportunity to comply
with the purposes of this Act, by order require such substance to
be packaged by such manufacturer (or packer) exclusively in
special packaging complying with such standard if he finds, after
opportunity for hearing, that such exclusive use of special packag-
ing is necessary to accomplish the purposes of this Act.
SEC. 5. (a) Proceedings to issue, amend, or repeal a regulation
prescribing a standard under section 3 shall be conducted in
accordance with the procedures prescribed by section 553 (other
than paragraph (3) (B) of the last sentence of subsection (b) of
such section) of title 5 of the United States Code unless the
[p.1671]
Secretary elects the procedures prescribed by subsection (e) of
section 701 of the Federal Foodj Drug and Cosmetic Act, in which
event such subsection and subsections (f) and (g) of such section
-------
STATUTES AND LEGISLATIVE HISTORY 783
701 shall apply to such proceedings. If the Secretary makes such
election, he shall publish that fact with the proposal required to be
published under paragraph (1) of such subsection (e).
(b) (1) In the case of any standard prescribed by a regulation
issued in accordance with section 553 of title 5 of the United States
Code, any person who will be adversely affected by such a standard
may, at any time prior to the 60th day after the regulation pre-
scribing such standard is issued by the Secretary, file a petition
with the United States Court of Appeals for the circuit in which
such person resides or has his principal place of business for a
judicial review of such standard. 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
shall file in the court the record of the proceedings on which the
Secretary based his standard, as provided in section 2112 of title
28 of the United States Code.
(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 was no oppor-
tunity to adduce such evidence in the proceeding before the Secre-
tary, the court may order such additional evidence (and evidence
in rebuttal thereof) to be taken before the Secretary in a hearing
or in such other 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, for the modification or setting
aside of his original standard, with the return of such additional
evidence.
(3) Upon the filing of the petition under paragraph (1) of this
subsection the court shall have judisdiction to review the standard
of the Secretary in accordance with subparagraphs (A), (B),
(C), and (D) of paragraph (2) of section 706 of title 5 of the
United States Code. If the court ordered additional evidence to be
taken under paragraph (2) of this subsection, the court shall also
review the Secretary's standard to determine if, on the basis of the
entire record before the court pursuant to paragraphs (1) and (2)
of this subsection, it is supported by substantial evidence. If the
court finds the standard is not so supported, the court may set
it aside.
(4) With respect to any standard reviewed under this subsec-
tion, the court may grant appropriate relief pending conclusion of
the review proceedings, as provided in section 705 of such title 5.
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784 LEGAL COMPILATION—PESTICIDES
(5) The judgment of the court affirming or setting aside, in
whole or in part, any such standard of the Secretary shall be
final, subject to review by the Supreme Court of the United States
upon certiorari or certification, as provided in section 1254 of title
28 of the United States Code.
SEC. 6. (a) For the purpose of assisting in carrying out the
purposes of this Act, the Secretary shall appoint a technical advisory
committee, designating a member thereof to be chairman, com-
posed of not more than eighteen members who are representative
of (1) the Department of Health, Education, and Welfare, (2)
the Department of Commerce, (3) manufacturers of household
substances subject to this Act, (4) scientists with expertise related
to this Act and licensed practitioners in the medical field, (5) con-
sumers, and (6) manufacturers of packages and closures for
household substances. The Secretary shall consult with the tech-
nical advisory committee in making findings and in establishing
standards pursuant to this Act.
[p.1672]
(b) Members of the technical advisory committee who are not
regular full-time employees of the United States shall, while
attending meetings of such committee, be entitled to receive com-
pensation at a rate fixed by the Secretary, but not exceeding $100
per diem, including traveltime, and while so serving away from
their homes or regular places of business, they may be allowed
travel expenses, including per diem in lieu of subsistence, as
authorized by section 5703 of title 5 of the United States Code for
persons in the Government service employed intermittently.
SEC. 7. (a) Section 2(p) of the Federal Hazardous Substances
Act (15 U.S.C. 1261 (p)) is amended—
(1) by striking out "which substance" in the part preced-
ing paragraph (1) and inserting in lieu thereof "if the pack-
aging or labeling of such substance is in violation of an
applicable regulation issued pursuant to section 3 or 4 of the
Poison Prevention Packaging Act of 1970 or if such sub-
stance" ; and
(2) by adding the following after below paragraph (2) :
"The term 'misbranded hazardous substance' also includes a house-
hold substance as defined in section 2 (2) (D) of the Poison Preven-
tion Packaging Act of 1970 if it is a substance described in
paragraph 1 of section 2 (f) of this Act and its packaging or label-
ing is in violation of an applicable regulation issued pursuant to
section 3 or 4 of the Poison Prevention Packaging Act of 1970.".
-------
STATUTES AND LEGISLATIVE HISTORY 785
(b) Section 2z(2) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 135 (z) (2)) is amended by striking out
the period at the end of paragraph (h) of such section and insert-
ing in lieu thereof "; or" and by adding at the end thereof a new
paragraph as follows:
(i) if its packaging or labeling is in violation of an appli-
cable regulation issued pursuant to section 3 or 4 of the Poison
Prevention Packaging Act of 1970."
(c) Section 403 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 343) is amended by adding at the end thereof a new
paragraph as follows:
" (n) If its packaging or labeling is in violation of an applicable
regulation issued pursuant to section 3 or 4 of the Poison Preven-
tion Packaging Act of 1970."
(d) Section 502 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 352) is amended by adding at the end thereof a new
paragraph as follows:
" (p) If it is a drug and its packaging or labeling is in violation
of an applicable regulation issued pursuant to section 3 or 4 of the
Poison Prevention Packaging Act of 1970."
(e) Section 503 (b) (2) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 353 (b) (2)) is amended by striking out "and (h) "
and inserting in lieu thereof ", (h), and (p)".
(f) Section 602 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 362) is amended by adding at the end thereof a new
paragraph as follows :
"(f) If its packaging or labeling is in violation of an applicable
regulation issued pursuant to section 3 or 4 of the Poison Preven-
tion Packaging Act of 1970."
SEC. 8. Whenever a standard established by the Secretary under
this Act applicable to a household substance is in effect, no State or
political subdivision thereof shall have any authority either to
establish or continue in effect, with respect to such household
substance, any standard for special packaging (and any exemption
therefrom and requirement related thereto) which is not identical
to the standard established under section 3 (and any exemption
therefrom and requirement related thereto) of this Act.
[p.1673]
SEC. 9. This Act shall take effect on the date of its enactment.
Each regulation establishing a special packaging standard shall
specify the date such standard is to take effect which date shall not
be sooner than one hundred and eighty days or later than one year
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786 LEGAL COMPILATION—PESTICIDES
from the date such regulation is final, unless the Secretary, for
good cause found, determines that an earlier effective date is in
the public interest and publishes in the Federal Register his reason
for such finding, in which case such earlier date shall apply. No
such standard shall be effective as to household substances subject
to this Act packaged prior to the effective date of such final
regulation.
Approved December 30,1970.
[p.1674]
1.6a (1) HOUSE COMMITTEE ON INTERSTATE AND FOR-
EIGN COMMERCE
H.R. REP. No. 91-1642, 91st Cong., 2d Sess. (1970)
POISON PREVENTION PACKAGING ACT OF 1970
DECEMBER 1,1970.—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
REPORT
together with
ADDITIONAL VIEWS
[To accompany S. 2162]
The Committee on Interstate and Foreign Commerce, to whom
was referred the bill (S. 2162) for special packaging to protect
children from serious personal injury or serious illness resulting
from handling, using, or ingesting household substances, and for
other purposes, having considered the same, reports favorably
thereon with an amendment and recommends that the bill as
amended do pass.
The amendment is as follows:
Strike out all after the enacting clause and insert in lieu thereof
the following:
SECTION 1. This act may be cited as the "Poison Prevention Packaging Act
of 1970."
SEC. 2. For the purpose of this Act—
(1) The term "Secretary" means the Secretary of Health, Education, and
Welfare.
(2) The term "household substance" means any substance which is custom-
arily produced or distributed for sale for consumption or use, or customar-
ily stored, by individuals in or about the household and which is—
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STATUTES AND LEGISLATIVE HISTORY 787
(A) a hazardous substance as that term is defined in section 2(f) of
the Federal Hazardous Substances Act (15 U.S.C. 1261 (f));
(B) an economic poison as that term is denned in section 2a of the Fed-
eral Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135 (a)) ;
(C) a food, drug, or cosmetic as those terms are defined in section 201
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) ; or
(D) a substance intended for use as fuel when stored in a portable
container and used in the heating, cooking, or refrigeration system of
a house.
[P-I]
(3) The term "package" means the immediate container or wrapping in
which any household substance is contained for consumption, use, or storage
by individuals in or about the household, and, for purposes of section 4(a) (2)
of this Act, also means any outer container or wrapping used in the retail
display of any such substance to consumers. Such term does not include—
(A) any shipping container or wrapping used solely for the transpor-
tation of any household substance in bulk or in quantity to manufactur-
ers, packers, or processors, or to wholesale or retail distributors thereof,
or
(B) any shipping container or outer wrapping used by retailers to ship
or deliver any household substance to consumers unless it is the only
such container or wrapping.
(4) The term "special packaging" means packaging that is designed or
constructed to be significantly difficult for children under five years of age
to open or obtain a toxic or harmful amount of the substance contained there-
in within a reasonable time and not difficult for normal adults to use proper-
ly, but does not mean packaging which all such children cannot open or obtain
a toxic or harmful amount within a reasonable time.
(5) The term "labeling" means all labels and other written, printed, or
graphic matter (A) upon any household substance or its package, or (B)
accompanying such substance.
SEC. 3. (a) The Secretary, after consultation with the technical advisory
committee provided for in section 6 of this Act, may establish in accordance
with the provisions of this Act, by regulation, standards for the special pack-
aging of any household substance if he finds that—
(1) the degree or nature of the hazard to children in the availability
of such substance, by reason of its packaging, is such that special pack-
aging is required to protect children from serious personal injury or
serious illness resulting from handling, using, or ingesting such sub-
stance; and
(2) the special packaging to be required by such standard is techni-
cally feasible, practicable, and appropriate for such substance.
(b) In establishing a standard under this section, the Secretary shall con-
sider—
(1) the reasonableness of such standard;
(2) available scientific, medical, and engineering data concerning spe-
cial packaging and concerning childhood accidental ingestions, illness,
and injury caused by household substances;
(3) the manufacturing practices of industries affected by this Act; and
(4) the nature and use of the household substance.
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788 LEGAL COMPILATION—PESTICIDES
(c) In carrying out this Act, the Secretary shall publish his findings, his
reasons therefor, and citation of the sections of statutes which authorize his
action.
(d) Nothing in this Act shall authorize the Secretary to prescribe specific
packaging designs, product content, package quantity, or, with the exception
of authority granted in section 4 (a) (2) of this Act, labeling. In the case
of a household substance for which special packaging is required under
a regulation under this section, the Secretary may in such regulation prohibit
the packaging of such substance in packages which he determines are
unnecessarily attractive to children.
SEC. 4. (a) For the purpose of making a household substance for which a
standard has been established pursuant to this Act readily available to elder-
ly or handicapped persons who may be unable to use special packaging and to
those households without young children, such household substance may be
packaged in packages not complying with such standard if—
(1) such substance is supplied to the consumer in at least one popular
size package which complies with such standard; and
(2) the packages which do not meet such standard bear, in conformity
with regulations of the Secretary, conspicuous labeling stating: "This
product is also available in special packaging which is recommended for
use in households with young children".
In the case of a household substance dispensed pursuant to an order of a
physician, dentist, or other licensed medical practitioner who is authorized
to prescribe, such substance may be sold in noncomplying packaging only
when directed in the order of such practitioner or when requested by the
purchaser.
(b) Whenever the Secretary determines that any household substance pack-
aged in noncomplying packages is not also being supplied by a manufacturer
or packer in popular size packages which comply with the standard estab-
lished for such substance, he may, after giving the manufacturer or packer
an opportunity to comply with the purpose of this Act, by order require such
substance to be packaged by such manufacturer or packer exclusively in spe-
cial packaging complying with such standard if he finds, after opportunity
for hearing, that such exclusive use of such packaging is necessary to accom-
plish the purposes of this Act.
[p. 2]
SEC. 5. (a) Proceedings to issue, amend, or repeal a regulation prescribing
a standard under section 3 shall be conducted in accordance with the proce-
dures prescribed by section 553 (other than clause (B) of the last sentence
of subsection (b) of such section) of title 5 of the United States Code unless
the Secretary elects the procedures prescribed by subsection (e) of section
701 of the Federal Food, Drug, and Cosmetic Act, in which event such sub-
section and subsections (f) and (g) of such section 701 shall apply to such
proceedings. If the Secretary makes such election, he shall publish that fact
with the proposal required to be published under paragraph (1) of such
subsection (e).
(b) In the case of any standard prescribed by a regulation issued in accor-
dance with section 553 of title 5 of the United States Code, any person who
will be adversely affected by such a standard may, at any time prior to the
60th day after the regulation prescribing such standard is issued by the Sec-
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STATUTES AND LEGISLATIVE HISTORY 789
retary, file a petition with the United States Court of Appeals for the cir-
cuit in which such person resides or has his principal place of business for a
judicial review of such standard. A copy of the petition shall be forthwith
transmitted by the clerk of the court to the Secretary or other officer desig-
nated by him for that purpose. The Secretary shall file in the court the
record of the proceedings on which the Secretary based his standard, as pro-
vided in section 2112 of title 28 of the United States Code.
(c) If the petitioner applies to the court for leave to adduce additional evi-
dence, and shows to the satisfaction of the court that such additional evi-
dence is material and that there was no opportunity 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
in a hearing or in such other 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 recommenda-
tion, if any, for the modification or setting aside of his original standard,
with the return of such additional evidence.
(d) Upon the filing of the petition under subsection (b) the court shall
have jurisdiction to review the standard of the Secretary in accordance with
subparagraphs (A), (B), (C), and (D) of paragraph (2) of section 706 of
title 5 of the United States Code. If the court ordered additional evidence to
be taken under subsection (c), the court shall also review the Secretary's
standard to determine if, on the basis of the entire record before the court
pursuant to subsections (b) and (c), it is supported by substantial evidence.
If the court finds the standard is not so supported, the court may set it aside.
With respect to any standard reviewed under this subsection, the court may
grant appropriate relief pending conclusion of the review proceeding's, as
provided in section 705 of such title 5.
(e) The judgment of the court affirming or setting aside, in whole or in
part, any such standard of the Secretary shall be final, subject to review by
the Supreme Court of the United States upon certiorari or certification, as
provided in section 1254 of title 28 of the United States Code.
SEC. 6. (a) For the purpose of assisting in carrying out the purposes of
this Act, the Secretary shall appoint a technical advisory committee, desig-
nating a member thereof to be chairman, composed of not more than eighteen
members who are representative of (1) the Department of Health, Educa-
tion, and Welfare, (2) the Department of Commerce, (3) manufacturers of
household substances subject to this Act, (4) scientists with expertise related
to this Act and licensed practitioners in the medical field, (5) consumers,
and (6) manufacturers of packages and closures for household substances.
The Secretary shall consult with the technical advisory committee in making
findings and in establishing standards pursuant to this Act.
(b) Members of the technical advisory committee who are not regular full-
time employees of the United States shall, while attending meetings of such
committee, be entitled to receive compensation at a rate fixed by the Secre-
tary, but not exceeding $100 per diem, including traveltime, and while so
serving away from their homes or regular places of business, they may be
allowed travel expenses, including per diem in lieu of subsistence, as author-
ized by section 5703 of title 5 of the United States Code for persons in the
Government service employed intermittently.
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790 LEGAL COMPILATION—PESTICIDES
SEX:. 7. (a) Section 2(p) of the Federal Hazardous Substances Act (15
U.S.C. 1261 (p) ) is amended—
(1) by striking out "which substance" in the part preceding para-
graph (1) and inserting in lieu thereof "if the packaging or labeling of
such substance is in violation of an applicable regulation or order issued
pursuant to section 3 or 4 of the Poison Prevention Packaging Act of
1970 or if such substance"; and
[p. 3]
(2) by adding the following after and below paragraph (2);
"The term 'misbranded hazardous substance' also includes a household sub-
stance as defined in section 2(2) (D) of the Poison Prevention Packaging Act
of 1970 if it is a substance described in paragraph 1 of section 2(f) of this
Act and its packaging or labeling is in violation of an applicable regulation
or order issued pursuant to section 3 or 4 of the Poison Prevention Packaging
Act of 1970.".
(b) Section 2z(2) of the Federal Insecticide, Fungicide, and Rodenticide
Act (7 U.S.C. 135(z) (2)) is amended by striking out the period at the end
of paragraph (h) of such section and inserting in lieu thereof "; or" and by
adding at the end thereof a new paragraph as follows:
"(i) if its packaging or labeling is in violation of an applicable regu-
lation or order issued pursuant to section 3 or 4 of the Poison Prevention
Packaging Act of 1970."
(c) Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
343) is amended by adding at the end thereof a new paragraph as follows:
"(n) If its packaging or labeling is in violation of an applicable regula-
tion or order issued pursuant to section 3 or 4 of the Poison Prevention Pack-
aging Act of 1970."
(d) Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
352) is amended by adding at the end thereof a new paragraph as follows:
"(p) If it is a drug and its packaging or labeling is in violation of an appli-
cable regulation or order issued pursuant to section 3 or 4 of the Poison Pre-
vention Packaging Act of 1970."
(e) Section 503 (b) (2) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 353(b) (2)) is amended by striking out "and (h)" and inserting in
lieu thereof ", (h),and (p)".
(f) Section 602 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
362) is amended by adding at the end thereof a new paragraph as follows:
"(f) If its packaging or labeling is in violation of an applicable regulation
or order issued pursuant to section 3 or 4 of the Poison Prevention Packaging
Act of 1970."
SEC. 8. Whenever a standard established by the Secretary under this Act
applicable to a household substance is in effect, no State or political subdivi-
sion thereof shall have any authority either to establish or continue in effect,
with respect to such household substance, any standard for special packaging
(and any exception therefrom and requirement related thereto) which is
not identical to the standard established under section 3 (and any exemp-
tion therefrom and requirement related thereto) of this Act.
SEC. 9. This Act shall take effect on the date of its enactment. Each regu-
lation establishing a special packaging standard shall specify the date such
standard is to take effect which date shall not be sooner than one hundred
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STATUTES AND LEGISLATIVE HISTORY 791
and eighty days or later than one year from the date such regulation is final,
unless the Secretary, for good cause found, determines that an earlier effec-
tive date is in the public interest and publishes in the Federal Register his
reason for such finding, in which case such earlier date shall apply. No such
standard shall be effective as to household substances subject to this Act
packaged prior to the effective date of such final regulation.
NEED FOR LEGISLATION
Statistics compiled by the national clearinghouse for poison
control centers document the need for additional measures to curb
accidental poisonings which largely involve small children. The
national clearinghouse, operated by the Office of Product Safety in
the Food and Drug Administration, determined from reports
received from 420 poison control centers located across the Nation
that over 105,000 ingestions of drugs and potentially toxic house-
hold products occurred in 1968. Children under 5 years of age
were involved in 71,563 of these ingestion accidents, and 4,129
hospitalizations occurred within this age group as a result of
these accidents. These data also showed that during 1968 the State
of Illinois reported 12,503 such ingestions by children under 5
years of age. In California, the Los Angeles poison control center,
which serves much of the southern portion of the State, reported
13,404 poisoning accidents involving this age group during 1968.
[p. 4]
The principal product categories involved in the 1968 national
poisoning accident data were, in descending order of frequency,
cleaning and polishing agents, cosmetics, pesticides, turpentine
and related paint products, and plants. Statistics compiled by the
national clearinghouse since it was established in 1957 have con-
sistently shown that drug's and medicines account for about half of
the total poisoning accidents involving small children. In this
category, aspirin is the most frequently involved product.
In the household specialties area, some chemicals cause serious
illness requiring lengthy hospitalization and produce injuries from
which the child may never fully recover. Furniture polishes con-
taining petroleum distillates are one of the frequently ingested
products which present a serious hazard to small children. On
ingestion, these petroleum distillates are readily aspirated into the
lungs and may lead to severe chemical pneumonitis in a matter
of minutes.
The Food and Drug Administration received reports in 1968 of
782 children under age 5 who accidentally ingested petroleum
distillate furniture polish. Of this number, 178 were hospitalized.
The previous year, 675 ingestions and 170 hospitalizations were
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792 LEGAL COMPILATION—PESTICIDES
attributed to these products. In 1966, there were 567 such inges-
tions, which resulted in 100 children being hospitalized. Eight
deaths occurred in this age group from the ingestion of petroleum
distillate type furniture polishes in both 1966 and 1967. Six such
deaths have been recorded for 1968, although mortality data for
that year was not complete at the time this figure was submitted.
During 1967, the last year for which complete mortality data
are available, the National Center for Health Statistics of the
Public Health Service recorded the death of 325 children from
accidental poisoning. While the total of 325 child deaths from this
cause may not appear large in proportion to the 105,000 ingestion
incidents reported for this age group, it is a tragic and needless
toll which dictates that every effort be employed to reduce and, if
possible, eliminate it.
In hearings held by your committee and the Senate committee on
this legislation and in agency reports to the committees, a number of
products were mentioned as potentially hazardous to children if not
appropriately packaged. Of course, mere reference to the hazards
of a particular product will not necessarily mean that its packaging
will be regulated under this legislation. Regulation under this legis-
lation must be preceded by a finding that as a result of the degree
or nature of the hazard to children in the availability of the
product, by reason of its packaging, special packaging is required
to prevent serious injury or illness and a finding that special
packaging for the product is technically feasible, practicable,
and appropriate.
MARKETING OF PRODUCTS IN CONVENTIONAL AND
SPECIAL SAFETY PACKAGES
The only major controversy with respect to this legislation
involves section 4 of the bill which sets forth the conditions under
which products in conventional packages may be marketed. The
controversial issue is whether special safety packages should
become the rule or the exception on the shelves of supermarkets
and other stores. Under the following conditions, the bill as
[p. 5]
reported by your committee would permit the marketing in con-
ventional packages of household substances for which a special
packaging standard was in effect:
First, prescription drugs dispensed pursuant to the order of a
physician, dentist, or other licensed medical practitioner, who is
authorized to prescribe, may be made available in conventional
-------
STATUTES AND LEGISLATIVE HISTORY 793
packaging only when such packaging is directed by such practi-
tioner in such order or when it is requested by the purchaser.
Secondly, any other household substance for which a special
packaging standard has been established may be made available in
conventional packages if such substance is supplied to the con-
sumer in special safety packages (complying with the standard)
in at least one popular size. Furthermore, manufacturers would be
required to label conventional packages with a conspicuous label
stating: "This product is also available in special packaging which
is recommended for use in households with young children".
[p. 6]
SECTION-BY-SECTION ANALYSIS
Section 1—Short title "Poison Prevention Packaging Act of 1970"
Section 2—Definitions
1. "Secretary" means Secretary of Health, Education, and
Welfare.
2. "Household substance" means any substance customarily sold
for use, or stored, in and around the household, which is—
(a) a hazardous substance subject to the Federal Hazard-
ous Substance Act;
(b) an economic poison as defined in the Federal Insecti-
cide, Fungicide, and Rodenticide Act;
(c) a food, drug, or cosmetic as defined in the Federal Food,
Drug, and Cosmetic Act; or
(d) a substance intended for use as fuel when stored in a
portable container and used in heating, cooking, or refrigera-
tion.
3. "Package" means the immediate container or wrapping in
which a household substance is kept, and, for labeling purposes,
any outer container or wrapping used for retail display, but does
not include shipping containers except those which are used for
shipment or delivery to consumers and which are the only
containers.
4. "Special packaging" means packaging designed to be signifi-
cantly difficult for children under 5 years of age to open or obtain
harmful amounts from the container within a reasonable time but
not difficult for normal adults to use properly. (Special packaging
does not mean packaging which all such children are unable to
open or obtain a harmful amount within a reasonable time.)
5. "Labeling" means labels or printed matter upon any house-
hold substance or its package or accompanying such substance.
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794 LEGAL COMPILATION—PESTICIDES
Section 3—Establishment of standards
(a) Authorizes the Secretary after consultation with the tech-
nical advisory committee, to establish, by regulation, standards for
special packaging if he finds—
(1) the hazard of the substance to children, by reason of its
packaging, is such that special packaging is required to
protect children; and
(2) the packaging to be required by the standard is tech-
nically feasible, practicable, and appropriate.
(b) In establishing standards, the Secretary shall consider—
(1) the reasonableness of the standard;
(2) scientific and technical data concerning special packag-
ing and the harmful effects caused by the substance;
(3) the manufacturing practices of affected industries; and
(4) the nature and use of the substance.
(c) The Secretary shall publish his findings, his reasons there-
for, and cite appropriate provisions of the applicable statutes
authorizing his actions in implementing the Act.
(d) The Secretary shall not specify package designs, product
content, package quantity, and labeling except as provided in sec-
tion 4; however, the Secretary may prohibit, by regulation, packag-
ing unnecessarily attractive to children.
[p. 7]
Section 4—Marketing of conventional packages
(a) To make available conventional packages to the handicapped
elderly or to households without children a substance may be
packaged without compliance to the standards if—
(1) such product is available in at least one popular size of
special packaging; and
(2) noncomplying packages are conspicuously labeled "This
product is also available in special packaging which is recom-
mended for use in households with young children."
Substances dispensed pursuant to prescription may be sold in non-
complying packages only when so directed by practitioner or
requested by the purchaser.
(b) Whenever the Secretary finds that substances packaged in
noncomplying packages by a manufacturer are not also being sup-
plied in popular size packages which comply with the standard, he
may, after providing an opportunity to comply, require the manu-
facturer to package exclusively in complying special packaging if
he finds, after opportunity for hearing, such exclusive use of spe-
cial packaging is necessary to accomplish the purposes of the Act.
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STATUTES AND LEGISLATIVE HISTORY 795
Section 5—Procedural requirements
(a) Procedures to issue regulations establishing packaging
standards shall be pursuant to the informal rulemaking provisions
of chapter 5 of title 5 of the United States Code unless the Secre-
tary elects the procedures under the Federal Food, Drug, and
Cosmetic Act. If the Secretary so elects he shall publish that fact
with the proposed standard.
(b) If proceedings are conducted pursuant to such informal
rulemaking provisions, adversely affected persons may, within 60
days after issuance of the standards, petition an appropriate court
of appeals for judicial review of the standard. A copy of the peti-
tion shall be transmitted to the Secretary by the clerk of the court
and the Secretary shall file the record upon which he based the
standard.
(c) If the petitioner shows that additional evidence is material
and that there was no opportunity to adduce such evidence during
the proceeding before the Secretary, the court may order such
additional evidence to be taken before the Secretary in a hearing
or by other means the court deems proper. The Secretary may
modify his findings, and modify or set aside the standard if indi-
cated by the additional evidence.
(d) The court shall have jurisdiction to set aside a standard if it
is not, on the basis of the entire record, supported by substantial
evidence.
(e) The judgment of the court may be appealed to the Supreme
Court.
Section 6—Advisory committee
(a) The Secretary shall establish a technical advisory committee
of not more than 18 members who are representative of (1)
Department of Health, Education, and Welfare, (2) Department
of Commerce, (3) manufacturers of household substances, (4)
scientists and medical practitioners, (5) consumers, and (6) manu-
facturers of packages or closures. The Secretary shall consult the
committee in making findings and establishing standards.
[p. 8]
(b) Compensation of committee members not regular employees
of the United States may be fixed by Secretary but not to exceed
$100 per day (including travel time) and travel expenses and per
diem authorized.
Section 7—Enforcement
(a) Amends the Federal Hazardous Substances Act to make
substances which are subject to that Act misbranded if they are
labeled or packaged in violation of section 3 or 4 of this Act.
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796 LEGAL COMPILATION—PESTICIDES
(b) Amends the Federal Insecticide, Fungicide, and Rodenticide
Act to make substances subject to that Act misbranded if the label-
ing or packaging is in violation of sections 3 or 4 of this Act.
(c) Amends section 403 of the Federal Food, Drug, and Cosmet-
ic Act to make food misbranded if packaged or labeled in violation
of sections 3 or 4 of this Act.
(d) Amends section 502 of the Federal Food, Drug, and Cosmet-
ic Act to make drugs misbranded if they are packaged or labeled
in violation of sections 3 or 4 of this Act.
(e) Amends section 503 of the Federal Food, Drug and Cosmet-
ic Act to make the Act applicable to prescription drugs.
(f) Amends section 602 of the Federal Food, Drug, and Cosmet-
ic Act to make cosmetics misbranded if they are packaged or
labeled in violation of sections 3 or 4 of this Act.
Section 8—Federal preemption
State and local regulations of special packaging, which are not
identical to Federal requirements, are preempted by Federal stan-
dards established by the Secretary.
Section 9—Effective date
This Act will become effective upon enactment. Standards for
special packaging shall specify their effective date but such date
shall not be prior to 180 days or later than 1 year from the date
such regulation is final unless the Secretary finds that an earlier
effective date is in the public interest and publishes his reasons
therefor. No such standard shall be applicable to substances pack-
aged prior to the effective date of the final regulation concerning
such substance.
[p. 9]
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,
Washington, D.C., July 23, 1970
Hon. HAKLEY 0. STAGGERS,
Chairman, Committee on Interstate and Foreign Commerce,
House of Representatives, Washington, D.C.
DEAR MR. CHAIRMAN : This letter is in response to your requests for reports
on H.R. 6179, a bill "To amend the Federal Food, Drug, and Cosmetic Act to
protect children and others from accidental death or injury by authorizing
safety closures to be required for drug containers;" H.R. 6180, a bill "To
amend the Hazardous Substances Act to provide safe packaging of toxic house-
hold substances in order to protect children;" H.R. 11783 and H.R. 14094,
identical bills "To amend the Federal Hazardous Substances Act to provide for
child-resistant packaging to protect children from serious personal injury or
serious illness resulting from handling, using, or ingesting any hazardous
substance, and for other purposes;" and S. 2162, a bill "To provide for special
packaging to protect children from serious personal injury or serious illness
-------
STATUTES AND LEGISLATIVE HISTORY 797
resulting from handling, using, or ingesting household substances, and for
other purposes."
[p. 15]
Household substances in violation of this Act would be considered misbrand-
ed under the Federal Hazardous Substances Act, the Federal Insecticide,
Fungicide, and Eodenticide Act, and the Federal Food, Drug, and Cosmetic
Act and subject to the penalties imposed under these Acts. Whenever a stan-
dard established under this Act is in effect, no State or political subdivision may
establish or continue in effect, with respect to any household substance, any
standard for the special packaging or labeling of such substance which is not
identical to the standard established under this Act.
[p. 17]
Sincerely,
ELLIOT L, RICHARDSON, Secretary
Enclosure.
[p. 20]
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
italics, existing law in which no change is proposed is shown in
roman) :
SECTION 2 (p) OF THE FEDERAL HAZARDOUS SUBSTANCES ACT
(p) The term "misbranded hazardous substance" means a
hazardous substance (including a toy, or other article intended for
use by children, which is a hazardous substance, or which bears or
contains a hazardous substance in such manner as to be suscept-
ible of access by a child to whom such toy or other article is en-
trusted) intended, or packaged in a form suitable, for use in the
household or by children, [which] if the packaging or labeling of
such substance is in violation of an applicable regulation or order
issued pursuant to section 3 or 4 of the Poison Prevention Packag-
ing Act of 1970 or if such substance, except as otherwise provided
by or pursuant to section 3, fails to bear a label—
(1) which states conspicuously (A) the name and place of
business of the manufacturer, packer, distributor or seller;
(B) the common or usual name or the chemical name (if there
be no common or usual name) of the hazardous substance or of
each component which contributes substantially to its hazard,
unless the Secretary by regulation permits or requires the use
of a recognized generic name; (C) the signal word "DAN-
GER" on substances which are extremely flammable, corro-
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798 LEGAL COMPILATION—PESTICIDES
sive, or highly toxic, (D) the signal word "WARNING" or
"CAUTION" on all other hazardous substances; (E) an
affirmative statement of the principal hazard or hazards, such
as "Flammable," "Combustible," "Vapor Harmful," "Causes
Burns," "Absorbed Through Skin," or similar wording descrip-
tive of the hazard; (F) precautionary measures describing
the action to be followed or avoided, except when modified by
regulation of the Secretary pursuant to section 3; (G) instruc-
tion, when necessary or appropriate, for first-aid treatment;
(H) the word "poison" for any hazardous substance which is
defined as "highly toxic" by subsection (h) ; (I) instructions
for handling and storage of packages which require special
care in handling or storage; and (J) the statement (i) "Keep
out of the reach of children" or its practical equivalent, or,
(ii) if the article is intended for use by children and is not a
banned hazardous substance, adequate directions for the pro-
tection of children from the hazard, and
*******
(2) on which any statements required under subparagraph
(1) of this paragraph are located prominently and are in the
English language in conspicuous and legible type in contrast
by typography, layout, or color with other printed matter on
the label. [p 23]
The term "misbranded hazardous substance" also includes a house-
hold substance as defined in section 2(2) (D) of the Poison Preven-
tion Packaging Act of 1970 if it is a substance described in
paragraph 1 of section 2(f) of this Act and its packaging or
labeling is in violation of an applicable regulation or order issued
pursuant to section 3 or 4 of the Poison Prevention Packaging
Act of 1970.
*******
SECTION 2z(2) OF THE FEDERAL INSECTICIDE, FUNGICIDE, AND
RODENTICIDE ACT
z. The term "misbranded" shall apply—
(1) to any economic poison or device if its labeling bears
any statement, design, or graphic representation relative
thereto or to its ingredients which is false or misleading in
any particular;
(2) to any economic poison—
*******
(h) if in the case of a plant regulator, defoliant, or desic-
cant when used as directed it shall be injurious to living man
-------
STATUTES AND LEGISLATIVE HISTORY 799
or other vertebrate animals, or vegetation to which it is
applied, or to the person applying such economic poison:
Provided, That physical or physiological effects on plants or
parts thereof shall not be deemed to be injury, when this is
the purpose for which the plant regulator, defoliant, or desic-
cant was applied, in accordance with the label claims and
recommendations [.]; or
(i) if its packaging or labeling is in violation of an applic-
able regulation or order issued pursuant to section 3 or U of
the Poison Prevention Packaging Act of 1970.
FEDERAL FOOD, DRUG, AND COSMETIC ACT
*******
MISBRANDED FOOD
SEC. 403. A food shall be deemed to be misbranded—
*******
(n) If its packaging or labeling is in violation of an applicable
regulation or order issued pursuant to section 3 or 4 of the Poison
Prevention Packaging Act of 1970.
*******
MISBRANDED DRUGS AND DEVICES
SEC. 502. A drug or device shall be deemed to be misbranded—
*******
(p) If it is a drug and its packaging or labeling is in violation of
an applicable regulation or order issued pursuant to section 3 or 4
of the Poison Prevention Packaging Act of 1970.
*******
[p. 24]
EXEMPTIONS IN CASE OF DRUGS AND DEVICES
SEC. 503. (a) * * *
*******
(b) (1) * * *
*******
(2) Any 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 (1), and the packaging
requirements of paragraphs (g) [and (h)], (h) and (p), if the
drug bears a label containing the name and address of the dis-
penser, the serial number and date of the prescription or of its
-------
800 LEGAL COMPILATION—PESTICIDES
filling, the name of the prescriber, and, if stated in the prescrip-
tion, 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 to a drug dispensed in violation of paragraph
(1) of this subsection.
*******
MISBRANDED COSMETICS
SEC. 602. A cosmetic shall be deemed to be misbranded—
*******
(f) If its packaging or labeling is in violation of an applicable
regulation or order issued pursuant to section 3 or 4 of the Poison
Prevention Packaging Act of 1970.
*******
PROVISIONS OF LAW REFERRED TO IN BILL
For the information of the Members the provisions of law
referred to in section 2(2) of the bill which defines the term
"household substance" are shown below:
SECTION 2(f) OF THE FEDERAL HAZARDOUS SUBSTANCES ACT (15
U.S.C. 1261 (f))
DEFINITIONS
SEC. 2. For the purposes of this Act—
*******
(f) The term "hazardous substance" means:
1. (A) Any substance or mixture of substances which (i) is
toxic, (ii) is corrosive, (iii) is an irritant, (iv) is a strong
sensitizer, (v) is flammable or combustible, or (vi) generates
pressure through decomposition, heat, or other means, if such
substance or mixture of substances may cause substantial
personal injury or substantial illness during or as a proximate
result of any customary or reasonably foreseeable handling
or use, including reasonably forseeable ingestion by children.
[p- 25]
(B) Any substances which the Secretary by regulation
finds, pursuant to the provisions of section 3(a), meet the
requirements of subparagraph 1 (A) of this paragraph.
(C) Any radioactive substance, if, with respect to such
substance as used in a particular class of article or as pack-
aged, the Secretary determines by regulation that the sub-
-------
STATUTES AND LEGISLATIVE HISTORY 801
stance is sufficiently hazardous to require labeling in accord-
ance with this Act in order to protect the public health.
(D) Any toy or other article intended for use by children
which the Secretary by regulation determines, in accordance
with section 3 (e) of this Act, presents an electrical, mechani-
cal, or thermal hazard.
2. The term "hazardous substance" shall not apply to economic
poisons subject to the Federal Insecticide, Fungicide, and Rodenti-
cide Act, nor to foods, drugs, and cosmetics subject to the Federal
Food, Drug, and Cosmetic Act, nor to substances intended for use
as fuels when stored in containers and used in the heating, cook-
ing, or refrigeration system of a house, but such term shall apply
to any article which is not itself an economic poisin within the
meaning of the Federal Insecticide, Fungicide, and Rodenticide
Act but which is a hazardous substance within the meaning of sub-
paragraph 1 of this paragraph by reason of bearing or containing
such an economic poison.
3. The term "hazardous substance" shall not include any source
material, special nuclear material, or byproduct material as
defined in the Atomic Energy Act of 1954, as amended, and regula-
tions issued pursuant thereto by the Atomic Energy Commission.
SECTON 2a OF THE FEDERAL INSECTICIDE, FUNGICIDE,
AND RODENTICIDE ACT
(7U.S.C. 135(a)>
SEC. 2. For the purposes of this Act—
*******
a. The term "economic poison" means (1) any substance or mix-
ture 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, which the Secretary shall declare
to be a pest, and (2) any substance or mixture of substances
intended for use as a plant regulator, defoliant or desiccant.
SECTIONS 201 (f), (g), AND (i) OF THE FEDERAL FOOD, DRUG,
AND COSMETIC ACT (21 U.S.C. 321)
SEC. 201. For the purposes of this Act-—
*******
(f) The term "food" means (1) articles used for food or drink
for man or other animals, (2) chewing gum, and (3) articles used
for components of any such article.
[p. 26]
-------
802 LEGAL COMPILATION—PESTICIDES
(g) (1) The term "drug" means (A) articles recognized in the
official United States Pharmacopeia, official Homeopathic Phama-
copeia of the United States, or official National Formulary, or any
supplement to any of them; and (B) articles intended for use in
the diagnosis, cure, mitigation, treatment, or prevention of disease
in man or other animals; and (C) articles (other than food)
intended to affect the structure or any function of the body of man
or other animals; and (D) articles intended for use as a component
of any articles specified in clause (A), (B),or (C); but does not
include devices or their components, parts, or accessories.
(2) The term "counterfeit drug" 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, 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 distributed by, such other drug manu-
facturer, processor, packer, or distributor.
*******
(i) The term "cosmetic" means (1) articles intended to be
rubbed, poured, sprinkled, or sprayed on, introduced into, or other-
wise applied to the human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or altering the appearance,
and (2) articles intended for use as a component of any such arti-
cles ; except that such term shall not include soap.
[p. 27]
1.6a (2) SENATE COMMITTEE ON COMMERCE
S. REP. No. 91-845, 91st Cong., 2d Sess. (1970)
POISON PREVENTION PACKAGING ACT
MAY 6 (legislative day, MAY 5), 1970.—Ordered to be printed
Mr. Moss, from the Committee on Commerce, submitted the
following
REPORT
[To accompany S. 2162]
The Committee on Commerce, to which was referred the bill
(S. 2162) to amend the Federal Hazardous Substances Act to pro-
vide for child-resistant packaging to protect children from serious
personal injury or serious illness resulting from handling, using,
-------
STATUTES AND LEGISLATIVE HISTORY 803
or ingesting- any hazardous substance, and for other purposes, hav-
ing considered the same, reports favorably thereon with amend-
ments and recommends that the bill as amended do pass.
PURPOSE AND BRIEF SUMMARY
The purpose of S. 2162 is to reduce injuries to, and illnesses of,
young children arising from ingestion of toxic or harmful sub-
stances customarily produced or distributed for sale for consump-
tion, use, or storage by individuals in or about the household. The
purpose of the bill is to be accomplished by requiring1 household
substances which are accessible to young children and which may
cause injury or illness to be contained in special packaging that is
significantly difficult for children under six years of age to open
or obtain a toxic or harmful amount of such substances within a
reasonable time, but not difficult for normal adults to use properly.
Special packaging is considered to be practicable because young
children lack adult capabilities of strength, mastery of more com-
plex operations and dexterity.
The scope of S. 2162 extends across all product lines and types
to include all substances customarily produced or distributed for
sale for consumption, use, or storage in or about the household.
The bill authorizes the Secretary of Health, Education and Wel-
fare to determine whether a substance should be contained in spe-
cial packaging on the basis of its degree or nature, of hazard to
children. It empowers the Secretary after consultation with a
[P. 1]
technical advisory committee to establish performance standards
for special packaging designed to protect young children against
obtaining harmful amounts of such substance. Failure to conform
to special packaging standards will result in the substance being
deemed misbranded under applicable provisions of the Federal
Hazardous Substances Act, the Food, Drug, and Cosmetic Act and
the Federal Insecticide, Fungicide, and Rodenticide Act and subject
to the penalties therein prescribed.
Although special packaging, by definition, is not to be difficult
for normal adults to use, the Committee recognized that elderly and
handicapped persons (such as those with infirmities of the hand)
may experience particular problems in opening special packaging.
Accordingly, the Committee has provided that substances for
which special packaging standards have been established may,
nonetheless, be marketed in one size of ordinary container not com-
plying with special packaging standard, or if dispensed pursuant
to prescription, may be sold in ordinary packaging at the purchas-
-------
804 LEGAL COMPILATION—PESTICIDES
er's request, for the use of the elderly and the handicapped. The
single size container is to bear a label statement: "This package for
households without young children."
The bill provides for creation of a technical advisory committee
composed of members representative of industry, the public and
the scientific and medical professions to advise the Secretary in
making findings and establishing standards for substances.
Although the bill would become effective upon enactment, it pro-
vides that the effective date of regulations will be not sooner than
180 days after final promulgation of regulations. Morever, the bill
provides that states may not establish or continue in effect stan-
dards not identical with federal standards.
[p. 2]
ANALYSIS OF THE BILL
TEXT OF THE BILL AS AMENDED
[S. 2162,91st Cong., second session]
[Strike out all after the enacting clause and insert the part printed in italic]
A BILL To amend the Federal Hazardous Substances Act to provide for
child-resistant packaging to protect children from serious personal
injury or serious illness resulting from handling, using, or ingesting any
hazardous substance, and for other purposes
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, [That this Act
may be cited as the "Poison Prevention Packaging Act of 1969".
[p. 4]
*******
SEC. 6.
(b) Section 2(z) (2) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 135(z) (2)) is amended by striking out
the period at the end of paragraph (h) of such section and inserting
in lieu thereof a semicolon and the word "or" and by adding at the
end thereof a> new paragraph as follows:
"(i) if its packaging or labeling is in violation of regulations
issued pursuant to sections 3 and 4 of the Poison Prevention
Packaging Act of 1970."
[p. 8]
SECTION BY SECTION ANALYSIS
*******
Section 6. This section sets forth amendments to the Federal
Hazardous Substances Act, the Federal Insecticide, Fungicide, and
Rodenticide Act, and the Federal Food, Drug, and Cosmetic Act
-------
STATUTES AND LEGISLATIVE HISTORY 805
such that failure to comply with special packaging standards pro-
mulgated under the Poison Prevention Packaging Act results in
packaging being "misbranded" and subject to the sanctions pro-
vided by the other applicable acts.
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 italic,
existing law in which no change is proposed is shown in roman) :
[p. 12]
SECTION 2 (z) OF THE FEDERAL INSECTICIDE, FUNGICIDE, AND
RODENTICIDE ACT AS AMENDED (7 U.S.C. 135 (z) )
(z) The term "misbranded" shall apply—
/j\ * * *
(2) to any economic poison—
*******
(i) if its packaging or labeling is in violation of regula-
tions issued pursuant to sections 3 and 4 of the Poison Pre-
vention Packaging Act of 1970. r 10,
Lp. ioj
DEPARTMENT OF AGRICULTURE,
OFFICE OF THE SECRETARY,
Washington, B.C., October 11,1969.
Hon. WARREN G. MAGNUSON,
Chairman, Committe on Commerce,
U.S. Senate.
DEAR MR. CHAIRMAN : This is in reply to your request of September 24,1969
for a report on S. 2162. The bill is entitled "To amend the Federal Hazardous
Substances Act to provide for child-resistant packaging to protect children
from serious personal injury or serious illness resulting from handling, using,
or ingesting any hazardous substance, and for other purposes."
The bill would amend the Federal Hazardous Substances Act to extend the
provisions of the Act for protecting the public health and the safety of
children. The bill would authorize the Secretary of Health, Education, and
Welfare to promulgate regulations establishing standards for the packaging
of any hazardous substance designed to prevent or substantially reduce the
hazard of serious injury or serious illness to children likely to handle, use, or
ingest any such hazardous substance. The term "package" is denned under the
bill. The interstate shipment of any hazardous substance, as defined under the
Act (15 U.S.C. 1261), would be prohibited unless the package complies with
the standards established by the Secretary. The term "hazardous substance"
as denned under the bill does not apply to economic poisons regulated by this
Department under the Federal Insecticide, Fungicide, and Rodenticide Act
as now provided for under the Federal Hazardous Substances Act. This
exemption notwithstanding, Section 3(d)(l) contains provisions for estab-
-------
806 LEGAL COMPILATION—PESTICIDES
lishing standards for the packaging of any hazardous substance, as denned
under the bill, when the Secretary of Health, Education, and Welfare deter-
mines that the degree or nature of the hazard involved in the presence or use
of any hazardous substance, as defined, is such that the objective of pro-
tecting the public health and safety of children requires special packaging.
This Department recommends the enactment of S. 2162 if amended as fol-
lows:
On p. 3, line 10, after the "comma" delete "the Federal Insecticide,
Fungicide, and Rodenticide Act,".
On p. 3, line 12, after the word "law" insert the following "with the
exception of the Federal Insecticide, Fungicide, and Rodenticide Act, as
amended".
A more detailed statement in support of this position is enclosed for your
information.
This Department works closely with the Department of Health, Education,
and Welfare on matters relating to pesticides. We will continue to coordinate
activities relating to safe packaging standards for pesticides in protecting
the health and safety of all persons using pesticides, especially children.
[p. 17]
The Bureau of the Budget advises that there is no objection to the pre-
sentation of this report from the standpoint of the Administration's program.
Sincerely,
CLIFFORD M. HARDIN,
Secretary of Agriculture.
EXPLANATION OF USDA POSITION ON S. 2162
The Department of Agriculture is responsible for administering
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),
as amended. This Act requires that all economic poisons moving
in interstate commerce must be registered with this Department.
In the registration process we are directly concerned with the
avoidance of any kind of hazard involving the use of economic
poisons, generally known as pesticides. We do not register a prod-
uct until a determination is made that the product is both effective
and safe for intended use according to directions on the product
label. Labels that are easy to read and understand are a necessity.
In March 1964, we strengthened our regulations with respect to
labeling of registered products. Key warning and caution state-
ments are required to be shown in a prominent place on the front
panel of the pesticide label. The label must include the statement
"Keep Out of Reach of Children" or its equivalent and a "signal"
word-such as "Danger", "Warning" or "Caution"-which draws
the user's attention to the necessity for handling the product with
care. The registered label must be affixed to a package so as to be
easily read.
The Act, as amended, does not presently include an affirmative
provision specifically relating to packaging of pesticides. We do,
-------
STATUTES AND LEGISLATIVE HISTORY 807
however, refuse or cancel registration of pesticides if it is deter-
mined that the form in which the product is marketed is such that
it may be considered an "attractive nuisance" especially to children
or that it may be a hazard in some other manner. For example,
registration has been refused or cancelled for rodent baits which
have the appearance of cookies or candy, and ant baits in bottle
caps. Also, the size of the package is considered. Limitations on
package sizes of the more hazardous products are made in order
to avoid or preclude purchase by the homeowner or inexperienced
user. We intend to continue pursuing this aspect of pesticide regis-
tration to the fullest extent possible under our present authority.
In addition, we are considering a legislative proposal to amend
the FIFRA in several respects.One of these is to strengthen the
present authority regarding packaging of pesticides required to
be registered. With respect to pesticides, this Department's pro-
posal would cover more types of products than those which would
include "the degree or nature of the hazard involved in the pres-
ence or use of any hazardous substance in or around households is
such that the objective of the protection of the public health and
safety of children requires the special packaging thereof".
Pesticides regulated under the FIFRA are now exempt from
the Hazardous Substances Act (15 U.S.C. 1261 (f) (2)). This
Department recommends that this exemption be continued with
[p. 18]
respect to safe packaging requirements on the basis that (a) simi-
lar authority is being considered for packaging of pesticides by
amendment to FIFRA; and (b) that enforcement of safe packag-
ing requirements can be conducted more effectively by this Depart-
ment as a condition of registration required in order for pesticide
products to move in interstate commerce. r .,
1.6a (3) COMMITTEE OF CONFERENCE
H.R. REP. No. 91-1755, 91st Cong., 2d Sess. (1970)
THE POISON PREVENTION PACKAGING ACT OF 1970
DECEMBER 15,1970.—Ordered to be printed
Mr. STAGGERS, from the committee of conference, submitted the
following
CONFERENCE REPORT
[To accompany S. 2162]
The committee of conference on the disagreeing votes of the two
Houses on the amendment of the House to the bill (S. 2162) to pro-
-------
808 LEGAL COMPILATION — PESTICIDES
vide for special packaging to protect children from serious personal
injury or serious illness resulting from handling, using, or ingest-
ing household substances, and for other purposes, having met, after
full and free conference, have agreed to recommend and do rec-
ommend 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
amendment insert the following:
SECTION 1. This Act may be cited as the "Poison Prevention
Packaging Act of 1970".
SEC. 2. For the purpose of this Act —
(1) The term "Secretary" means the Secretary of Health, Educa-
tion, and Welfare.
(2) The term "household substance" means any substance which
is customarily produced or distributed for sale for consumption or
use, or customarily stored, by individuals in or about the household
and which is —
(A) a hazardous substance as that term is defined in section
%(f) of the Federal Hazardous Substances Act (15 U.S.C.
(B) an economic poison as that term is defined in section 2a
of the Federal Insecticide, Fungicide, and Rodenticide Act
(7 U.S.C. 135(a));
(C) a food, drug, or cosmetic as those terms are defined in
section 201 of the Federal Food, Drug, and Cosmetic Act. (21
U.S.C. 321); or
(D) a substance intended for use as fuel when stored in a
portable container and used in the heating, cooking, or refrig-
eration system of a house.
[p.l]
(3) The term "package" means the immediate container or wrap-
ping in which any household substance is contained for consump-
tion, use, or storage by individuals in or about the household, and,
for purposes of section 4(a) (2) of this Act, also means any outer
container or wrapping used in the retail display of any such sub-
stance to consumers. Such term does not include —
(A) any shipping container or wrapping used solely for the
transportation of any household substance in bulk or in quan-
tity to manufacturers, packers, or processors, or to wholesale
or retail distributors thereof, or
-------
STATUTES AND LEGISLATIVE HISTORY 809
(B) any shipping container or outer wrapping used by retail-
ers to ship or deliver any household substance to consumers
unless it is the only such container or wrapping.
(4) The term "special packaging" means packaging ttiat is
designed or constructed to be significantly difficult for children
under five years of age to open or obtain a toxic or harmful amount
of the substance contained therein within a reasonable time a/nd
not difficult for normal adults to use properly, but does not mean
packaging which all such children cannot open or obtain a toxic
or harmful amount within a reasonable time.
(5) The term "labeling" means all labels and other written,
printed, or graphic matter (A) upon any household substance or
its package, or (B) accompanying such substance.
SEC. 3. (a) The Secretary, after consultation with the technical
advisory committee provided for in section 6 of this Act, may estab-
lish in accordance with the provisions of this Act, by regulation,
standards for the special packaging of any household substance if
he finds that—
(1) the degree or nature of the hazard to children in the
availability of such substance, by reason of its packaging, is
such that special packaging is required to protect children
from serious personal injury or serious illness resulting from
handling, using, or ingesting such substance; and
(2) the special packaging to be required by such standard
is technically feasible, practicable, and appropriate for such
substance.
(b) In establishing a standard under this section, the Secretary
shall consider—
(1) the reasonableness of such standard;
(2) available scientific, medical, and engineering data con-
cerning special packaging and concerning childhood acciden-
tal ingestions, illness, and injury caused by household sub-
stances;
(3) the manufacturing practices of industries affected by
his Act; and
(4) the nature and use of the household substance.
(c) In carrying out this Act, the Secretary shall publish his
findings, his reasons therefor, and citation of the sections of stat-
utes which authorize his action.
(d) Nothing in this Act shall authorize the Secretary to prescribe
specific packaging designs, product content, package quantity, or,
with the exception of authority granted in section 4(a)(2) of this
Act, labeling. In the case of a household substance for which special
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810 LEGAL COMPILATION—PESTICIDES
packaging is required pursuant to a regulation under this section,
the Secretary may in such regulation prohibit the packaging of
[P. 2]
such substance in packages which he determines are unnecessarily
attractive to children.
SEC. 4. (a) For the purpose of making any household substance
which is subject to a standard established under section 3 readily
available to elderly or handicapped persons unable to use such
substance when packaged in compliance with such standard, the
manufacturer or packer, as the case may be, may package any
household substance, subject to such a standard, in packaging of
a single size which does not comply with such standard if—
(1) the manufacturer (or packer) also supplies such sub-
stance in packages which comply with such standard; and
(2) the packages of such substance which do not meet such
standard bear conspicuous labeling stating: "This package
for households without young children"; except that the Sec-
retary may by regulation prescribe a substitute statement to
the same effect for packaging too small to accommodate such
labeling.
(b) In the case of a household substance which is subject to such
a standard and which is dispensed pursuant to an order of a phy-
sician, dentist, or other licensed medical practitioner authorized
to prescribe, such substance may be dispensed in noncomplying
packages only when directed in such order or when requested by
the purchaser.
(c) In the case of a household substance subject to such a stand-
ard which is packaged under subsection (a) in a noncomplying
package, if the Secretary determines that such substance is not
also being supplied by a manufacturer (or packer) in popular size
packages which comply with such standard, he may, after giving
the manufacturer (or packer) an opportunity to comply with the
purposes of this Act, by order require such substance to be pack-
aged by such manufacturer (or packer) exclusively in special pack-
aging complying with such standard if he finds, after opportunity
for hearing, that such exclusive use of special packaging is neces-
sary to accomplish the purposes of this Act.
SEC. 5. (a) Proceedings to issue, amend, or repeal a regulation
prescribing a standard under section 3 shall be conducted in accord-
ance with the procedures prescribed by section 553 (other than
paragraph (3)(B) of the last sentence of subsection (b) of such
section) of title 5 of the United States Code unless the Secretary
elects the procedures prescribed by subsection (e) of section 701 of
-------
STATUTES AND LEGISLATIVE HISTORY 811
the Federal Food, Drug, and Cosmetic Act, in which event such
subsection and subsections (f) and (g) of such section 701 shall
apply to such proceedings. If the Secretary makes such election,
he shall publish that fact with the proposal required to be pub-
lished under paragraph (1) of such subsection (e).
(b) (1) in the case of any standard prescribed by a regulation
issued in accordance with section 553 of title 5 of the United States
Code, any person who will be adversely affected by such a standard
may, at any time prior to the 60th day after the regulation pre-
scribing such standard is issued by the Secretary, file a petition
with the United States Court of Appeals for the circuit in which
such person resides or has his principal place of business for a
judicial review of such standard. 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
shall file in the court the record of the proceedings on which the
[p. 3]
Secretary based his standard, as provided in section 2112 of title
28 of the United States Code.
(2) If the petitioner applies to the court for leave to adduce addi-
tional evidence, and shows to the satisfaction of the court that
such additional evidence is material and that there was no oppor-
tunity to adduce such evidence in the proceeding before the Secre-
tary, the court may order such additional evidence (and evidence
in rebuttal thereof) to be taken before the Secretary in a hearing
or in such other manner, and upon such terms and conditions as
to the facts, or make new findings, by reason of the additional evi-
dence so taken, and he shall file such modified or new findings, and
his recommendation, if any, for the modification or setting aside
of his original standard, with the return of such additional evi-
dence.
(3) Upon the filing of the petition under paragraph (1) of this
subsection the court shall have jurisdiction to review the standard
of the Secretary in accordance with subparagraphs (A), (B), (C),
and (D) of paragraph (2) of section 706 of title 5 of the United
States Code. If the court ordered additional evidence to be taken
under paragraph (2) of this subsection, the court shall also review
the Secretary's standard to determine if, on the basis of the entire
record before the court pursuant to paragraphs (1) and (2) of this
subsection, it is supported by substantial evidence. If the court
finds the standard is not so supported, the court may set it aside.
(4) With respect to any standard reviewed under this subsection,
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812 LEGAL COMPILATION—PESTICIDES
the court may grant appropriate relief pending conclusion of the
review proceedings, as provided in section 705 of such title 5.
(5) The judgment of the court affirming or setting aside, in
whole or in part, any such standard of the Secretary shall be final,
subject to review by the Supreme Court of the United States upon
certiorari or certification, as provided in section 1254 of title 28
of the United States Code.
SEC. 6. (a) For the purpose of assisting in carrying out the pur-
poses of this Act, the Secretary shall appoint a technical advisory
committee, designating a member thereof to be chairman, com-
posed of not more than eighteen members who are representative
of (1) the Department of Health, Education, and Welfare, (2) the
Department of Commerce, (3) manufacturers of household sub-
stances subject to this Act, (4) scientists with expertise related to
this Act and licensed practitioners in the medical field, (5) consum-
ers, and (6) manufacturers of packages and closures for household
substances. The Secretary shall consult with the technical advisory
committee in making findings and in establishing standards pur-
suant to this Act.
(b) Members of the technical advisory committee who are not
regular full-time employees of the United States shall, while
attending meetings of such committee, be entitled to receive com-
pensation at a rate fixed by the Secretary, but not exceeding $100
per diem, including traveltime, and while so serving away from
their homes or regular places of business, they may be allowed
travel expenses, including per diem in lieu of subsistence, as
authorized by section 5703 of title 5 of the United States Code for
persons in the Government service employed intermittently.
SEC. 7. (a) Section 2(p) of the Federal Hazardous Substances
Act (15 U.S.C. 1261(p)) is amended—
[P. 4]
(1) by striking out "which substance" in the part preceding
paragraph (1) and inserting in lieu thereof "if the packaging
or labeling of such substance is in violation of an applicable
regulation issued pursuant to section 3 or 4 of the Poison Pre-
vention Packaging Act of 1970 or if such substance"; and
(2) by adding the following after and below paragraph (2):
"The term 'misbranded hazardous substance' also includes a house-
hold substance as defined in section 2(2) (D) of the Poison Preven-
tion Packaging Act of 1970 if it is a substance described in para-
graph 1 of section 2(f) of this Act and its packaging or labeling is
in violation of an applicable regulation issued pursuant to section
3 or 4 of the Poison Prevention Packaging Act of 1970."
-------
STATUTES AND LEGISLATIVE HISTORY 813
(b) Section 2z(2) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 135(z)(2)) is amended by striking out
the period at the end of paragraph (h) of such section and insert-
ing in lieu thereof "; or" and by adding at the end thereof a new
paragraph as follows:
"(i) if its packaging or labeling is in violation of an appli-
cable regulation issued pursuant to section 3 or 4 of the Poison
Prevention Packaging Act of 1970."
(c) Section 403 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 343) is amended by adding at the end thereof a new
paragraph as follows :
"(n) If its packaging or labeling is in violation of an appli-
cable regulation issued pursuant to section 3 or 4 of the Poison
Prevention Packaging Act of 1970."
(d) Section 502 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 352) is amended by adding at the end thereof a new
paragraph as follows:
"(p) If it is a drug and its packaging or labeling is in violation of
an applicable regulation issued pursuant to section 3 or 4 of the
Poison Prevention Packaging Act of 1970."
(e) Section 503(b)(2) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 353(b) (2)) is amended by striking out "and (h)" and
inserting in lieu thereof ", (h), and (p)".
(f) Section 602 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 362) is amended by adding at the end thereof a new
paragraph as follows:
"(f) If its packaging or labeling is in violation of an applicable
regulation issued pursuant to section 3 or 4 of the Poison Preven-
tion Packaging Act of 1970."
SEC. 8. Whenever a standard established by the Secretary under
this Act applicable to a household substance is in effect, no State
or political subdivision thereof shall have any authority either to
establish or continue in effect, with respect to such household sub-
stance, any standard for special packaging (and any exemption
therefrom and requirement related thereto) which is not identical
to the standard established under section 3 (and any exemption
therefrom and requirement related thereto) of this Act.
SEC. 9. This Act shall take effect on the date of its enactment.
Each regulation establishing a special packaging standard shall
specify the date such standard is to take effect which date shall
not be sooner than one hundred and eighty days or later than one
year from the date such regulation is final, unless the Secretary,
[p. 5]
-------
814 LEGAL COMPILATION—PESTICIDES
for good cause found, determines that an earlier effective date is
in the public interest and publishes in the 'Federal Register his
reason for such finding, in which case such earlier date shall apply.
No such standard shall be effective as to household substances sub-
ject to this Act packaged prior to the effective date of such final
regulation.
And the House agree to the same.
HARLEY 0. STAGGERS,
JOHN E. Moss,
JOHN M. MURPHY,
HASTINGS KEITH,
Managers on the Part of the House.
WARREN G. MAGNUSON,
PHILIP A. HART,
FRANK E. Moss,
JAMES B. PEARSON,
CHARLES E. GOODELL,
Managers on the Part of the Senate.
[p. 6]
STATEMENT OF THE MANAGERS ON THE
PART OF THE HOUSE
The managers on the part of the House at the conference on the
disagreeing votes of the two Houses on the amendment of the
House to the bill (S. 2162) to provide for special packaging to
protect children from serious personal injury or serious illness
resulting from handling, using, or ingesting household substances,
and for other purposes, submit the following statement in explana-
tion of the effect of the action agreed upon by the conferees and
recommended in the accompanying conference report:
The House amendment to the bill struck out all of the Senate bill
after the enacting clause and inserted a substitute amendment.
The committee of conference has agreed to a substitute for both
the Senate bill and the House amendment to the bill. Except for
technical, clarifying, and conforming changes, the following state-
ment explains the differences between the House amendment and
the substitute agreed to in conference.
The conference substitute is identical to the bill as amended by
the House except for the provision in section 4 (a) authorizing
manufacturers (or packers) of household substances subject to
special packaging requirements to package such substances in
packages not complying with such requirements for the purpose of
making such substances readily available to the elderly and handi-
-------
STATUTES AND LEGISLATIVE HISTORY 815
capped unable to use such substances in packages complying with
such requirements.
In section 4 (a), as amended by the House, the manufacturer (cr
packer) of a household substance subject to a special packaging
requirement was given similar authority to package such a sub-
stance in noncomplying packages if he also packaged such sub-
stance in at least one package size complying with such standard
and if the noncomplying packages were labeled to show that there
were complying packages which should be used in households with
young children. Thus, under the House version, most of the pack-
ages used in the marketing of such substances could be noncomply-
ing packages. Complying packaging could have been the exception
to general marketing practices.
Section 4(a) of the conference substitute is designed to make
substances subject to special packaging requirements available to
the elderly and handicapped in packages which do not unneces-
sarily hinder them in their use of such substances. A manufacturer
(or packer) is permitted under such section to use for such a sub-
stance one size of packaging which does not meet the special pack-
aging requirements if he also supplies the substance in packaging
which complies with the requirements. In addition, the noncomply-
ing packaging must be labeled to show it is not for households with
young children.
It is expected that specially packaged substances will be the rule
rather than the exception for substances regulated under this legis-
lation. Also, it is expected that manufacturers (or packers) will not
[p. 7]
exact a premium price for specially packaged substances and will
make every effort to assure the adequate distribution and adver-
tisement of specially packaged substances so that the public will
become acquainted with special packaging and familiar with its
operation. Since the purpose of this section is to assist the elderly
and handicapped, it is expected that the manufacturer (or pack-
ers) will use noncomplying packaging only when the required
special packaging is of a kind that will create significant difficulty
in use for the elderly and handicapped, and that manufacturers
(or packers) will in using noncomplying packaging choose pack-
age sizes most likely to be used by the elderly and handicapped.
Although it has been pointed out that the majority of house-
holds do not contain young children, it was felt that, in order to
adequately protect young children, the marketing in complying
packages of substances subject to special packaging requirements
had to be made the general marketing practice.
-------
816 LEGAL COMPILATION—PESTICIDES
Section 4(b) of the conference substitute is identical to the
House amendment and provides that in the case of household sub-
stances which are dispensed only upon prescription such sub-
stances (if subject to special packaging requirements) may be
dispensed in noncomplying packages only when directed in the
prescription or when requested by the purchaser.
Section 4(c) of the conference substitute is the same as section
4(b) of the House version and authorizes the Secretary to require
exclusive use of special packaging for substances if (1) he deter-
mines that the substance is not being supplied by the manufacturer
(or packer) in popular sizes of special packages; and (2) after
giving the manufacturer (or packer) an opportunity to comply
with the purposes of this act, he finds, after opportunity for hear-
ing, that exclusive use of special packaging is necessary to accom-
plish the purposes of this act.
The legislation as passed by the Senate contained a special pro-
vision (section 3(e)) authorizing the Secretary to exempt cate-
gories of substances subject to special packaging requirements.
That special provision was not contained in the House version
and is not contained in the conference substitute because the Sec-
retary may provide such exemptions while prescribing such special
packaging requirements. In addition, if the Secretary wishes to
make such an exemption after he has prescribed special packaging
requirements, he may use the informal rulemaking authority pro-
vided in section 5 of the conference substitute to amend the regu-
lation prescribing such requirement.
HARLEY 0. STAGGERS,
JOHN E. Moss,
JOHN M. MURPHY,
HASTINGS KEITH,
Managers on the Part of the House.
[p. 8]
1.6a (4) CONGRESSIONAL RECORD, VOL. 116 (1970)
1.6a (4) (a) May 11: Considered and passed Senate, pp. 14796-
14798
[No Relevant Discussion on Pertinent Section]
1.6a (4) (b) Dec. 7: Considered and passed House, amended, pp.
40188-40193
[No Relevant Discussion on Pertinent Section]
l.Ga (4) (c) Dec. 16: Senate and House agreed to conference
report, pp. 41729-41730,41948
[No Relevant Discussion on Pertinent Section]
-------
STATUTES AND LEGISLATIVE HISTORY 817
1.6b FEDERAL ENVIRONMENTAL PESTICIDE CONTROL
ACT OF 1972
October 21, 1972, P.L. 92-516, §3(3), 86 Stat. 998
To amend the Federal Insecticide, Fungicide, and Rodenticide 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 this Act
may be cited as the "Federal Environmental Pesticide Control
Act of 1972". , ^
AMENDMENTS TO OTHER ACTS
SEC. 3. The following Acts are amended by striking out the terms
"economic poisons" and "an economic poison" wherever they
appear and inserting in lieu thereof "pesticides" and "a pesticide"
respectively :
*******
(2) The Poison Prevention Packaging Act, as amended (15
U.S.C. 1471etseq.);
1.6b (1) HOUSE COMMITTEE ON AGRICULTURE
H.R. REP. No. 92-511, 92d Cong. 1st Sess. (1971)
[No Relevant Discussion on Pertinent Section]
1.6b (2) SENATE COMMITTEE ON AGRICULTURE AND
FORESTRY
S. REP. No. 92-838, 92 Cong., 2d Sess. (1972)
[No Relevant Discussion on Pertinent Section]
1.6b (3) SENATE COMMITTEE ON COMMERCE
S. REP. No. 92-970, 92d Cong., 2d Sess. (1972)
[No Relevant Discussion on Pertinent Section]
1.6b (4) COMMITTEE OF CONFERENCE
H.R. REP. No. 92-1540, 92d Cong., 2d Sess. (1972)
[No Relevant Discussion on Pertinent Section]
1.6b (5) CONGRESSIONAL RECORD :
1.6b(5)(a) VOL. 117 (1971): Nov. 8, 9: Considered and passed
House
1.6b(5)(b) VOL. 118 (1972): Sept. 26: Considered and passed
Senate, amended
[No Relevant Discussion on Pertinent Section]
-------
818 LEGAL COMPILATION—PESTICIDES
1.6b(5)(c) VOL. 118 (1972), Oct. 5: Senate agreed to conference
report
[No Relevant Discussion on Pertinent Section]
1.6b(5)(d) VOL. 118 (1972), Oct. 12: House agreed to conference
report.
[No Relevant Discussion on Pertinent Section]
1.7 HEARINGS; PRESIDING EMPLOYEES; POWERS AND
DUTIES; BURDEN OF PROOF; EVIDENCE; RECORD AS A
BASIS OF DECISION, 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)]
ADMINISTRATIVE PROCEDURE ACT
§ 556. Hearings; presiding employees; powers and duties; bur-
den of proof; evidence; record as basis of decision
(a) This section applies, according to the provisions thereof, to
hearings required by section 553 or 554 of this title to be con-
ducted in accordance with this section.
(b) There shall preside at the taking of evidence—
(1) the agency;
(2) one or members of the body which comprises the
agency; or
(3) one or more hearing examiners appointed under sec-
tion 3105 of this title.
This subchapter does not supercede the conduct of specified classes
of proceedings, in whole or in part, by or before boards or other
employees specially provided for by or designated under statute.
The functions of presiding employees and of employees participat-
ing in decisions in accordance with section 557 of this title shall be
conducted in an impartial manner. A presiding or participating
employee may at any time disqualify himself. On the filing in good
faith of a timely and sufficient affidavit of personal bias or other
disqualification of a presiding or participating employee, the
agency shall determine the matter as a part of the record and
decision in the case.
(c) Subject to published rules of the agency and within its
powers, employees presiding at hearings may—
(1) administer oaths and affirmations;
(2) issue subpenas authorized by law;
(3) rule on offers of proof and receive relevant evidence;
(4) take depositions or have depositions taken when the
ends of justice would be served;
-------
STATUTES AND LEGISLATIVE HISTORY 819
(5) regulate the course of the hearing;
(6) hold conferences for the settlement or simplification of
the issues by consent of the parties;
(7) dispose of procedural requests or similar matters;
(8) make or recommend decisions in accordance with sec-
tion 557 of this title; and
(9) take other action authorized by agency rule consistent
with this subchapter.
(d) Except as otherwise provided by statute, the proponent of
a rule or order has the burden of proof. Any oral or documentary
evidence may be received, but the agency as a matter of policy
shall provide for the exclusion of irrelevant, immaterial, or unduly
repetitious evidence. A sanction may not be imposed or rule or
order issued except on consideration of the whole record or those
parts thereof cited by a party and supported by and in accordance
with the reliable, probative, and substantial evidence. A party is
entitled to present his case or defense by oral or documentary
evidence, to submit rebuttal evidence, and to conduct such cross-
examination as may be required for a full and true disclosure of
the facts. In rule making or determining claims for money or bene-
fits or applications for initial licenses an agency may, when a party
will not be prejudiced thereby, adopt procedures for the submis-
sion of all or part of the evidence in written form.
(e) The transcript of testimony and exhibits, together with all
papers and requests filed in the proceeding, constitutes the exclu-
sive record for decision in accordance with section 557 of this title
and, on payment of lawfully prescribed costs, shall be made avail-
able to the parties. When an agency decision rests on official notice
of a material fact not appearing in the evidence in the record, a
party is entitled, on timely request, to an opportunity to show the
contrary.
Pub.L. 89-554, Sept. 6,1966, 80 Stat. 386.
1.7a ADMINISTRATIVE PROCEDURE IN HEARINGS ACT
June 11, 1946, P.L. 79-404, 60 Stat. 241
HEARINGS
SEC. 7. In hearings which section 4 or 5 requires to be conducted
pursuant to this section—
(a) PRESIDING OFFICERS.—There shall preside at the taking of
evidence (1) the agency, (2) one or more members of the body
which comprises the agency, or (3) one or more examiners
appointed as provided in this Act; but nothing in this Act shall
-------
820 LEGAL COMPILATION—PESTICIDES
be deemed to supersede the conduct of specified classes of pro-
ceedings in whole or part by or before boards or other officers
specially provided for by or designated pursuant to statute. The
functions of all presiding officers and of officers participating in
decisions in conformity with section 8 shall be conducted in an
impartial manner. Any such officer may at any time withdraw if
he deems himself disqualified; and, upon the filing in good faith
of a timely and sufficient affidavit of personal bias or disqualifi-
cation of any such officer, the agency shall determine the matter as
a part of the record and decision in the case.
(b) HEARING POWERS.—Officers presiding at hearings shall
have authority, subject to the published rules of the agency and
within its powers, to (1) administer oaths and affirmations,
(2) issue subpenas authorized by law, (3) rule upon offers of
proof and receive relevant evidence, (4) take or cause depositions
to be taken whenever the ends of justice would be served thereby,
(5) regulate the course of the hearing, (6) hold conferences for
the settlement or simplification of the issues by consent of the
parties, (7) dispose of procedural requests or similar matters,
(8) make decisions or recommend decisions in conformity with
section 8, and (9) take any other action authorized by agency rule
consistent with this Act.
(c) EVIDENCE.—Except as statutes otherwise provide, the pro-
ponent of a rule or order shall have the burden of proof. Any oral
or documentary evidence may be received, but every agency shall
as a matter of policy provide for the exclusion of irrelevant, im-
material, or unduly repetitious evidence and no sanction shall be
imposed or rule or order be issued except upon consideration of
the whole record or such portions thereof as may be cited by any
party and as supported by and in accordance with the reliable,
probative, and substantial evidence. Every party shall have the
right to present his case or defense by oral or documentary evi-
dence, to submit rebuttal evidence, and to conduct such cross-
examination as may be required for a full and true disclosure of
the facts. In rule making or determining claims for money or
benefits or applications for initial licenses any agency may, where
the interest of any party will not be prejudiced thereby, adopt
procedures for the submission of all or part of the evidence in
written form.
(d) RECORD.—The transcript of testimony and exhibits, to-
gether with all papers and requests filed in the proceeding, shall
[p.241]
constitute the exclusive record for decision in accordance with
-------
STATUTES AND LEGISLATIVE HISTORY 821
section 8 and, upon payment of lawfully prescribed costs, shall be
made available to the parties. Where any agency decision rests on
official notice of a material fact not appearing in the evidence in
the record, any party shall on timely request be afforded an oppor-
tunity to show the contrary.
[p.242]
1.7a (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. , ^
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
-------
822 LEGAL COMPILATION—PESTICIDES
may be protected. By the same token, administrators are provided
with a simple course to follow in making administrative determina-
tions. The jurisdiction of the courts is clearly stated. The bill thus
provides for public information, administrative operation, and
judicial review.
SUBSTANCE OP THE BILL.—What the bill does in substance may
be summarized under four headings:
1. It provides the 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 (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 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 per-
mit interested parties to submit their views in writing for agency
consideration before issuing general regulations (sec. 4). No hear-
ings are required by the bill unless statutes already do so in a par-
ticular 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
[p. 7]
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 ex-
-------
STATUTES AND LEGISLATIVE HISTOIU 823
aminers to preside at hearings and make or participate in decisions.
While the administrative power and procedure provisions of
sections 4 through 9 are law apart from court review, the provi-
sions for judicial review provide parties with a method of enforc-
ing 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 ("^c. 3).
3. Those which provide for different kinds of procedures
such as rule making (sec. 4), adjudications (sec. 5), and
miscellaneous 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 appli-
cation because, while some functions and some operations may
not lend themselves to formal procedure, all administrative
operations should as a matter of pclicy 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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824 LEGAL COMPILATION—PESTICIDES
cise of any other agency authority. Section 9 limits sanctions, and
section 10 provides for judicial review. „..
[p. oj
*******
(b) PROCEDURES.—After such notice, the agency must afford
interested 'persons an opportunity to participate in the rule mak-
ing at least to the extent of submitting written data, views, or
argument; 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
interest as discussed in connection with subsection (a) will natu-
rally govern the agency's determination of the extent to which
public proceedings
[p. 14]
(c) RULE AND RULE MAKING.—"Rule" is defined as any agency
statement of general applicability designed to implement, interpret
or prescribe law, policy, organization, procedure, or practice re-
quirements. "Rule making" means agency process for the formula-
tion, amendment, or repeal of a rule and includes any prescription
for the future of rates, wages, financial structures, etc., etc.
The definition of "rule" is important because it prescribes the
kind of operation that is subject to section 4 rather than section 5.
The specifications of the activities that are involved in rule making
is included in order to comprehend them beyond any possible
question. They are defined as rules to the extent that, whether of
general or particular applicability, they formally prescribe a
course of conduct for the future rather than merely pronounce
existing rights or liabilities. It should be noted that rule making
is exempted from some of the general requirements of sections 7
and 8 relating to the details of hearings and decisions.
(d) ORDER AND ADJUDICATION.—"Order" means the final dis-
position of any •matter, other than rule making but including
licensing, whether or not affirmative, negative, or declaratory in
form. "Adjudication" means the agency process for the formula-
tion of an order.
-------
STATUTES AND LEGISLATIVE HISTORY 825
The term "order" is defined to exclude rules. "Licensing" is
specifically included to remove any possible question at the outset.
Licenses involve a pronouncement of present rights of named par-
ties although they may also prescribe terms and conditions for
future observance. It should be noted, however, that licensing is
exempted from some of the provisions of sections 5, 7, and 8 relat-
ing to hearings and decisions.
(e) LICENSE AND LICENSING.—"License" is defined to include
any form of required official permission such as certificate, charter,
etc. "Licensing" is defined to include agency process respecting the
grant, renewal, modification, denial, revocation, etc., of a license.
This definition supplements subsection (d). Later provisions of
the bill distinguish between initial lincenses and renewals or other
licensing proceedings. A further distinction might have been
drawn between licenses for a term, such as radio licenses, and
those of indefinite duration, such as certificates of convenience
and necessity. r 11,
should go. Matters of great import, or those where the public sub-
mission 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 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 presented 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 othenvise provided by the agency
for good cause found and published or (2) in the case of rules rec-
ognizing 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
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826 LEGAL COMPILATION—PESTICIDES
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. More-
over, 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 be-
cause 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
(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
legislation, the equivalent of a right of petition is recognized in
interested 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 an agency by such a
petition might be such as to require the agency to act to prevent
the rule from continuing or becoming vulnerable upon judicial
[P-15]
review, through declaratory judgment or other procedures pur-
suant to section 10. . .. „
(b) PROCEDURE.—The agency is required first to afford parties
an opportunity for the settlement or adjustment of issues (where
time, the nature of the proceeding, and the public interest permit)
followed, to the extent that issues are not so settled, by hearing and
decision under sections 7 and 8.
The preliminary settlement-by-consent provision of this sub-
section is of the greatest importance. Such adjustments may go to
the whole or any part of any case. The limitation of the require-
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STATUTES AND LEGISLATIVE HISTORY 827
ment to cases in which "time, the nature of the proceeding, and
the public interest permit" does not mean that formal proceedings,
to the exclusion of prior opportunity for informal settlement, lie
in the discretion of any agency irrespective of the facts, legal situ-
ation presented, or practical aspects of the case. It does not mean
that agencies have an arbitrary choice, or that they may consult
their mere preference or convenience. It is intended to exempt only
situations in which, for example, (1) time is unavoidably lacking,
(2) the nature of the proceeding is such that for example (as in
some forms of rule making) the great number of parties or possi-
ble parties makes it unlikely that any adjustment could be reached,
and (3) the administrative function requires immediate execution
in order to protect the tangible and demonstrable requirements of
public interest.
[p. 17]
SEC. 6. ANCILLARY MATTERS.—The provisions of section 6 relat-
ing to incidental or miscellaneous rights, powers, and procedures
do not override contrary provisions in other parts of the bill.
The purpose of this introductory exception, which reads "except
as otherwise provided in this act," is to limit, for example, the
right of appearance provided in subsection (a) so as not to author-
ize improper ex parte conferences during formal hearings and
pending formal decisions under sections 7 and 8.
[P. 18]
SEC. 7. HEARINGS.—Section 7 relating to agency hearings applies
only where hearings are required by sections 4 or 5.
As heretofore stated in connection with sections 4 and 5, the bill
requires no hearings unless other statutes contain such a require-
ment in particular cases of either rule making or adjudication. This
section 7, therefore, is merely supplementary to sections 4 or 5 in
the relevant cases.
(a) PRESIDING OFFICERS.—The hearing must be held either by
the agency, a member or members of the board which comprises it,
one or more examiners, or other officers specially provided for in
[p.20]
or designated by other statutes. All presiding and deciding offi-
cers are to operate impartially. They may at any time withdraw
if they deem themselves disqualified and, upon the filing of a prop-
er affidavit of personal bias or disqualification against them,
the agency is required to determine the matter as a part of the
record and decision in the case.
This subsection provides two mutually exclusive methods of
hearing—by the agency itself (or one or more of its members)
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828 LEGAL COMPILATION—PESTICIDES
or by subordinate officers. A third kind of hearing officer recog-
nized in this subsection is one specially provided for or named
in other statutes. Whoever presides is subject to the remaining
provisions of the bill. They must conduct the hearing in a strict-
ly impartial manner, rather than as the representative of an
investigative or prosecuting authority, but this does not mean
that they do not have the authority and duty—as a court does—
to make sure that all necessary evidence is adduced and to keep
the hearing orderly and efficient. The provision for affidavits of
bias or personal disqualification requires a decision thereon by the
agency in, and as a part of, the case; it thereby becomes subject
to administrative and judicial review. That decision might be
made upon the affidavit alone, as for example, the protest might
be dismissed as insufficient on its face. The agency itself may hear
any relevant argument or facts, or it may designate an examiner
to do so. The effect which bias or disqualification shown upon the
record might have would be determined by the ordinary rules of
law and the other provisions of this bill. If it appeared or were dis-
covered late, it would have the effect—where issues of fact or
discretion were important and the conduct and demeanor of
witnesses relevant in determining them—of rendering the recom-
mended decisions or initial decisions of such officers invalid. This
consequence will require agencies and examiners themselves to
take care that they do not sit where subject to disqualification or
conduct themselves in a manner which will invalidate the pro-
ceedings.
(b) HEARING POWERS.—Presiding officers, subject to the rules
of procedure adopted by the agency and within its powers, have
authority to (1) administer oaths, (2) issue such subpenas as are
authorized by law, (3) receive evidence and rule upon offers of
proof, (4) take depositions or cause depositions to be taken, (5)
regulate the hearing, (6) hold conferences for the settlement or
simplification of the issues, (7) dispose of procedural requests,
(8) make decisions or recommended decisions under section 8 of
the bill, and (9) exercise other authority as provided by agency
rule consistent with the remainder of the bill.
This subsection does not expand the powers of agencies. It is
designed to assure that the presiding officer will perform a real
function rather than serve merely as a notary or policeman. He
would have and should independently exercise all the powers
numbered in the subsection. The agency itself—which must ulti-
mately either decide the case, or consider reviewing it, or hear
appeals from the examiner's decision—should not in effect con-
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STATUTES AND LEGISLATIVE HISTORY 829
duct hearings from behind the scenes where it cannot know the
detailed happenings in the hearing room and does not hear or
see the private parties.
(c) EVIDENCE.—Except as statutes otherwise provide, the pro-
ponent of a rule or order has the burden of proof. While any evi-
dence may be received, as a matter of policy agencies are required
to provide for the exclusion of irrelevant and unduly repetitious
evidence and no sanction may be imposed or rule or order be
[p. 21]
issued except as supported by relevant, reliable, and probative
evidence. Any party may present his case or defense by oral or
documentary evidence, submit rebuttal evidence, and conduct
reasonable cross-examination. However, in the case of rule mak-
ing or determining applications for initial licenses, the agency
may adopt procedures for the submission of evidence in written
form so far as the interest of any party will not be prejudiced
thereby.
That the proponent of a rule or order has the burden of proof
means not only that the party initiating the proceeding has the
general burden of coming forward with a prima facie case but
that other parties, who are proponents of some different result,
also for that purpose have a burden to maintain. Similarly the
requirement that no sanction be imposed or rule or order be issued
except upon evidence of the kind specified means that the propo-
nents of a denial of relief must sustain such denial by that kind of
evidence. For example, credible and credited evidence submitted
by the applicant for a license may not be ignored except upon the
requisite kind and quality of contrary evidence. No agency is
authorized to stand mute and arbitrarily disbelieve credible evi-
dence. Except as applicants for a license or other privilege may
be required to come forward with a prima facie showing, no agen-
cy is entitled to presume that the conduct of any person or status
of any enterprise is unlawful or improper.
The second and primary sentence of the subsection is framed on
the theory that an administrative hearing is to be compared with
an equity proceeding in the courts. The mere admission of evi-
dence is not to be taken as prejudicial error (there being no lay
jury to be protected from improper influence) although irrelevant
and unduly repetitious evidence is to be excluded as a matter of
efficiency and good practice; and no finding or conclusion may be
entered except upon evidence which is plainly of the requisite
materiality and competence; that is, "relevant, reliable, and pro-
bative evidence." Thus while the exclusionary "rules of evidence"
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830 LEGAL COMPILATION—PESTICIDES
do not apply except as the agency may as a matter of good prac-
tice simplify the hearing and record by excluding obviously
improper or unnecessary evidence, the standards and principles of
probity and reliability of evidence must be the same as those pre-
vailing in courts of law or equity in nonadministrative cases. There
are no real rules of probity and reliability even in courts of law,
but there are certain standards and principles—usually applied
tacitly and resting mainly upon common sense—which people
engaged in the conduct of responsible affairs instinctively under-
stand and act upon. They may vary with the circumstances and
kind of case, but they exist and must be rationally applied. These
principles, under this subsection, are to govern in administrative
proceedings.
The right of cross-examination extends, in a proper case, to
written evidence submitted pursuant to the last sentence of the
subsection as well as to cases in which oral or documentary evi-
dence is received in open hearing. Even in the latter case, sub-
ject to the appropriate safeguards, technical data may as a mat-
ter of convenience be reduced to writing and introduced as in
courts. The written evidence provision of the last sentence of the
subsection is designed to cover situations in which, as a matter
of general rule or practice, the submission of the whole or sub-
stantial portions of the evidence in a case is done in written form.
In those situations, however, the provision limits the practice to
[p. 22]
specified classes of cases and, even then, only where and to the
extent that "the interest of any party will not be prejudiced
thereby." To the extent that cross-examination is necessary to
bring out the truth, the party should have it. Also, an adequate
opportunity must be provided for a party to prepare and submit
appropriate rebuttal evidence.
(d) RECORD. — The record of evidence taken and papers filed
is exclusive for decision and, upon payment of costs, is available
to the parties. Where decision rests on official notice of a mate-
rial fact not appearing in the evidence of record, any party may
on timely request show the contrary.
The "official notice" mentioned relates to the administrative
practice of taking facts as shown and true though not in the
record. This is done by analogy to judicial notice familiar in
court procedure. Where agencies take such notice they must so
state on the record or in their decisions and then afford the par-
ties an opportunity to show the contrary.
[p. 23]
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STATUTES AND LEGISLATIVE HISTORY 831
SEC. 12. CONSTRUCTION AND EFFECT.—Nothing in the bill is to
diminish constitutional rights or limit or repeal additional require-
ments of law. Requirements of evidence and procedure are to apply
equally to agencies and private persons except as otherwise pro-
vided by law. The unconstitutionally of any portion or applica-
tion of the bill is not to affect other portions or applications. Agen-
cies are granted all authority necessary to comply with the bill.
Subsequent legislation is not to modify the bill except as it may
do so expressly. The bill would become law three months after
its approval except that sections 7 and 8 take effect six months
after approval, the requirements of section 11 become effective a
year after approval, and no requirement is mandatory as to any
agency proceeding initiated prior to the effective date of such
requirement. r OQ
LP- Ł™ \
V. GENERAL COMMENTS
The bill is designed to operate as a whole and, as previously
stated, its provisions are interrelated. At the same time, how-
ever, there are certain provisions which touch on subjects long
regarded as of the highest importance. On those subjects, such as
the separation of examiners from the agencies they serve, there
has been a wide divergence of views. The committee has in such
cases taken the course which it believes will suffice without being
excessive. Moreover, amendatory or supplementary legislation
can supply any deficiency which experience discloses in those
cases. The committee believes that special note should be made of
the following situations:
The exemption of rule making and determining initial applica-
tions for licenses from provisions of sections 5 (c), 7 (c), and
8 (a) may require change if, in practice, it develops that they are
too broad. Earlier in this report, in commenting upon some of
those provisions, the committee has expressed its reasons for the
language used and has stated that, where cases present sharply
contested issues of fact, agencies should not as a matter of good
practice take advantage of the exemptions.
Should the preservation in section 7 (a) of the "conduct of
specified classes of proceedings in whole or part by or before
boards or other officers specially provided for by or designated
pursuant to statute" prove to be a loophole for avoidance of the
examiner system in any real sense, corrective legislation would
be necessary. That provision is not intended to permit agencies
to avoid the use of examiners but to preserve special statutory
types of hearing officers who contribute something more than
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832 LEGAL COMPILATION—PESTICIDES
examiners could contribute and at the same time assure the par-
ties fair and impartial procedure.
The basic provision respecting evidence in section 7 (c) —
requiring that any agency action must be supported by plainly
"relevant, reliable, and probative evidence"—will require full
compliance by agencies and diligent enforcement by reviewing
courts. Should that language prove insufficient to fix and main-
tain the standards of proof, supplemental legislation will become
necessary.
The "substantial evidence" rule set forth in section 10 (e) is
exceedingly important. As a matter of language, substantial evi-
dence would seem to be an adequate expression of law. The diffi-
culty comes about in the practice of agencies to rely upon (and
of courts to tacitly approve) something less—to rely upon suspi-
cion, surmise, implications, or plainly incredible evidence. 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
record the evidence in a given instance is sufficiently substantial
to support a finding, conclusion, or other agency action as a mat-
ter of law. In [p 3Q]
HEARINGS
Sec. 7. In hearings which section 4 or 5 requires to be conducted pursuant
to this section—
(a) Presiding officers.—There shall preside at the taking of evidence (1)
the agency, (2) one or more members of the body which comprises the agency,
or (3) one or more examiners appointed as provided in this Act; but nothing
in this Act shall be deemed to supersede the conduct of specified classes of
proceedings in whole or part by or before boards or other officers specially
provided for by or designated pursuant to statute. The functions of all presid-
ing officers and of officers participating in decisions in conformity with section
8 shall be conducted in an impartial manner. Any such officer may at any time
withdraw if he deems himself disqualified; and, upon the filing in good faith
of a timely and sufficient affidavit of personal bias or disqualification of any
such officer, the agency shall determine the matter as a part of the record and
decision in the case.
(b) Hearing powers.—Officers presiding at hearings shall have authority
subject to the published rules of the agency and within its powers, to (1)
administer oaths and affirmations, (2) issue subpenas authorized by law, (3)
rule upon offers of proof and receive relevant evidence, (4) take or cause
depositions to be taken whenever the ends of justice would be served thereby,
(5) regulate the course of the hearing, (6) hold conferences for the settlement
or simplification of the issues by consent of the parties, (7) dispose of proce-
dural requests or similar matters, (8) make decisions or recommend decisions
in conformity with section 8, and (9) take any other action authorized by
agency rule consistent with this Act.
(c) Evidence.—Except as statutes otherwise provide, the proponent of a
rule or order shall have the burden of proof. Any evidence, oral or documen-
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STATUTES AND LEGISLATIVE HISTORY 833
tary, may be received, but every agency shall as a matter of policy provide for
the exclusion of immaterial and unduly repetitious evidence and no sanction
shall be imposed or rule or order be issued except as supported by relevant,
reliable, and probative evidence. Every party shall have the right to present
his case or defense by oral or documentary evidence, to submit rebuttal evi-
dence, and to conduct such cross-examination as may be required for a full and
true disclosure of the facts. In rule making or determining claims for money
or benefits or applications for initial licenses any agency may, where the
interest of any party will not be prejudiced thereby, adopt procedures for the
submission of all or part of the evidence in written form.
(d) Record.—The transcript of testimony and exhibits, together with all
papers and requests filed in the proceeding, shall constitute the exclusive record
for decision in accordance with section 8 and, upon payment of lawfully pre-
scribed costs, shall be made available to the parties. Where any agency decision
rests on official notice of a material fact not appearing in the evidence in the
record, any party shall on timely request be afforded an opportunity to show
the contrary.
[p- 35]
Section 7: This section applies to those cases of statutory hearing which are
required by sections 4 and 5 to be conducted pursuant to section 7. Subject to
the numerous exceptions contained in sections 4 and 5, they are cases in which
an order or rule is to be made upon the basis of the record in a statutory
hearing.
Section 7 (a): The subsection is not intended to disturb presently existing
statutory provisions which explicitly provide for certain types of hearing
officers. Among such are (1) joint hearings before officers of the Federal
agencies and persons designated by one or more States, (2) where officers of
more than one agency sit, (3) quota allotment cases under the Agricultural
Adjustment Act of 1938, (4) marine casualty investigation boards, (5) regis-
[P. 41]
ters of the General Land Office, elections, are not covered. The second sentence
of the subsection enables the agency to take official notice of material facts
which do not appear in the record, provided the taking of such notice is stated
in the record or decision, but in such cases any party affected shall on timely
request be afforded an opportunity to show the contrary.
Section 8: This section applies to all hearings held under section 7.
[p. 43]
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834 LEGAL COMPILATION—PESTICIDES
1.7a (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 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".
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 there-
after, 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.
[P-I]
ADJUDICATION
SEC. 5. In every case of adjudication required by statute to be determined on
the record after opportunity for an agency hearing, except to the extent that
there is involved (1) any matter subject to a subsequent trial of the law and
the facts de novo in any court; (2) the selection or tenure of an officer or
-------
STATUTES AND LEGISLATIVE HISTORY 835
employee of the United States other than examiners appointed pursuant to
section 11; (3) proceedings in which decisions rest solely on inspections,
tests, or elections; (4) the conduct of military, naval, or foreign-affairs func-
tions; (5) cases in which an agency is acting as an agent for a court; and
(6) the certification of employee representatives—
(a) NOTICE.—Persons entitled to notice of an agency hearing shall be time-
ly informed of (1) the time, place, and nature thereof; (2) the legal author-
ity and jurisdiction under which the hearing is to be held; and (3) the mat-
ters of fact and law asserted. In instances in which private persons are the
moving parties, other parties to the proceeding shall give prompt notice of
issues controverted in fact or law; and in other instances agencies may by
rule require responsive pleading. In fixing the times and places for hearings,
due regard shall be had for the convenience and necessity of the parties of
their representatives.
(b) PROCEDURE.—The agency shall afford all interested parties opportunity
for (1) the submission and consideration of facts, argument, offers of settle-
ment, or proposals of adjustment where time, the nature of the proceeding,
and the public interest permit and (2) to the extent that the parties are
unable so to determine any controversy by consent, hearing, and decision upon
notice and in conformity with sections 7 and 8.
(c) SEPARATION OF FUNCTIONS.—The same officers who preside at the recep-
tion of evidence pursuant to section 1 shall make the recommended decision
or initial decision required by section 8 except where such officers become
unavailable to the agency. Save to the extent required for the disposition of
ex parte matters as authorized by law, no such officer shall consult any per-
son or party on any fact in issue unless upon notice and opportunity for all
parties to participate; nor shall such officer be responsible to or subject to the
supervision or direction of any officer, employee, or agent engaged in the per-
formance of investigative or prosecuting functions for any agency. No officer,
employee, or agent engaged in the performance of investigative or prosecu-
ting functions for any agency in any case shall, in that or a factually related
case, participate or advise in the decision, recommended decision, or agency
review pursuant to section 8 except as witness or counsel in public proceed-
ings. This subsection shall not apply in determining applications for initial
licenses or to proceedings involving the validity or application of rates, facili-
ties, or practices of public utilities or carriers; nor shall it be applicable in
any manner to the agency or any member or members of the body comprising
the agency.
(d) DECLARATORY ORDERS.—The agency is authorized in its sound discre-
tion, with like effect as in the case of other orders, to issue a declaratory
order to terminate a controversy or remove uncertainty.
ANCILLARY MATTERS
Sec. 6. Except as otherwise provided in this Act—
(a) APPEARANCE.—Any person compelled to appear in person before any
agency or representative thereof shall be accorded the right to be accompanied,
represented, and advised by counsel or, if permitted by the agency, by other
qualified representative. Every party shall be accorded the right to appear in
person or by or with counsel or other duly qualified representative in any
agency proceeding. So far as the orderly conduct of public business permits,
any interested person may appear before any agency or its responsible officers
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836 LEGAL COMPILATION—PESTICIDES
or employees for the presentation, adjustment, or determination of any issue,
request, or controversy in any proceeding (interlocutory, summary, or other-
wise) or in connection with any agency function. Every agency shall pro-
ceed with reasonable dispatch to conclude any matter presented to it except
that due regard shall be had for the convenience and necessity of the parties
or their representatives. Nothing herein shall be construed either to grant
or to deny any person who is not a lawyer the right to appear for or rep-
resent others before any agency or in any agency proceeding.
(b) INVESTIGATIONS.—No process, requirement of a report, inspection, or
other investigative act or demand shall be issued, made, or enforced in any
manner or for any purpose except as authorized by law. Every person com-
pelled to submit data or evidence shall be entitled to retain or, on payment
of lawfully prescribed costs, procure a copy or transcript thereof, except that
in a nonpublic investigatory proceeding the witness may for good cause be
limited to inspection of the official transcript of his testimony.
(c) SUBPENAS.—Agency subpenas authorized by law shall be issued to any
party upon request and, as may be required by rules of procedure, upon a
statement or showing of general relevance and reasonable scope of the evi-
dence sought. Upon contest the court shall sustain any such subpena or simi-
lar process or demand to the extent that it is found to be in accordance with
law and, in any proceeding for enforcement, shall issue an order requiring the
appearance of the witness or the production of the evidence or data within
a reasonable time under penalty of punishment for contempt in case of con-
tumacious failure to comply.
(d) DENIALS.—Prompt notice shall be given of the denial in whole or in
part of any written application, petition, or other request of any interested
person made in connection with any agency proceeding. Except in affirming
a prior denial or where the denial is self-explanatory, such notice shall be
accompanied by a simple statement of procedural or other grounds.
HEARINGS
Sec. 7. In hearings which section 4 or 5 requires to be conducted pursuant
to this section—
(a) PRESIDING OFFICERS.—There shall preside at the taking of evidence (1)
the agency, (2) one or more members of the body which comprises the agency,
or (3) one or more examiners appointed as provided in this Act; but nothing
in this Act shall be deemed to supersede the conduct of specified classes of
proceedings in whole or part by or before boards or other officers specially pro-
vided for by or designated pursuant to statute. The functions of all presiding
officers and of officers participating in decisions in conformity with section 8
shall be conducted in an impartial manner. Any such officer may at any time
withdraw if he deems himself disqualified; and, upon the filing in good faith of
a timely and sufficient affidavit of personal bias or disqualification of any such
officer, the agency shall determine the matter as a part of the record and
decision in the case.
(b) HEARING POWERS.—Officers presiding at hearings shall have authority,
subject to the published rules of the agency and within its powers, to (1)
administer oaths and affirmations, (2) issue subpenas authorized by law, (3)
rule upon offers of proof and receive relevant evidence, (4) take or cause depo-
sitions to be taken whenever the ends of justice would be served thereby, (5)
regulate the course of the hearing, (6) hold conferences for the settlement or
-------
STATUTES AND LEGISLATIVE HISTORY 837
simplification of the issues by consent of the parties, (7) dispose of proce-
dural requests or similar matters, (8) make decisions or recommend decisions
in conformity with section 8, and (9) to take any other action authorized
by agency rule consistent with this Act.
[P-4]
(c) EVIDENCE.—Except as statutes otherwise provide, the proponent of a
rule or order shall have the burden of proof. Any oral or documentary evidence
may be received, but every agency shall as a matter of policy provide for the
exclusion of irrelevant, immaterial, or unduly repetitious evidence and no
sanction shall be imposed or rule or order be issued except upon considera-
tion of the whole record or such portions thereof as may be cited by any party
and as supported by and in accordance with the reliable, probative, and sub-
stantial evidence. Every party shall have the right to present his case or
defense by oral or documentary evidence, to submit rebuttal evidence, and to
conduct such cross-examination as may be required for a full and true dis-
closure of the facts. In rule making or determining claims for money or bene-
fits or applications for initial licenses any agency may, where the interest of
any party will not be prejudiced thereby, adopt procedures for the submission
of all or part of the evidence in written form.
(d) RECORD.—The transcript of testimony and exhibits, together with all
papers and requests filed in the proceeding, shall constitute the exclusive
record for decision in accordance with section 8 and, upon payment of law-
fully prescribed costs, shall be made available to the parties. Where any agen-
cy decision rests on official notice of a material fact not appearing in the evi-
dence in the record, any party shall on timely request be afforded an oppor-
tunity to show the contrary.
[p. 5]
SECTION 7. HEARINGS
Section 7 relating to agency hearings applies only where hear-
ings are otherwise required by statute and by section 4 or 5.
As heretofore stated in connection with sections 4 and 5, the
bill requires no hearings unless other statutes contain such a
requirement in particular cases of either rule making or adjudi-
cation and even then section 5 contains numerous functional excep-
tions. This section 7, therefore, is merely supplementary to sec-
tion 4 or 5 in the relevant cases. These formal hearing provisions
are not in derogation of the settlement provisions of sections 5
and 6 (a), which require that parties be given every opportunity
to simplify or settle cases. Hearings are not to be used as indi-
rect burdens or penalties.
SECTION 7 (A). PRESIDING OFFICERS AT HEARINGS
The hearing must be held either by the agency, a member or
members of the board which comprises it, one or more examiners,
or other officers specially provided for in or designated pursuant
to other statutes. All presiding and deciding officers are to oper-
ate impartially. They may at any time withdraw if they deem
themselves disqualified and, upon the filing of a proper affidavit
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838 LEGAL COMPILATION—PESTICIDES
of personal bias or disqualification against them, the agency is
required to determine the matter as a part of the record and deci-
sion in the case.
The section provides two mutually exclusive methods of hear-
ing—by the agency itself (or one or more of its members) or by
subordinate officers. Also recognized as hearing officers are those,
including State representatives, specially provided for or named
in other statutes. But the reference to other statutory officers
would not prevent an agency, such as the head of a department
or a board, from utilizing examiners as provided by the bill. On
the other hand, statutory provisions authorizing the use of
employees or attorneys generally to be presiding officers are super-
seded. The preservation of the "conduct of specified classes of
proceedings by or before boards or other officers specially pro-
vided by or designated pursuant to statute" is not a loophole for
the avoidance of the examiner system; it is intended to preserve
only special types of statutory hearing officers who contribute
some special qualifications, as distinguished from examiners other-
wise provided in the bill, and at the same time assure the parties
fair and impartial procedure.
Those who so preside are subject to the remaining provisions
of the bill. They must conduct the hearing in a strictly impartial
and considerate manner, rather than as representatives of an
investigative or prosecuting authority. They may make sure that
all necessary evidence is adduced and keep the hearing orderly
and efficient. No examiner may proceed in willful disregard of
[p. 34]
law. Presiding officers must conduct themselves in accord with
the requirements of this bill and with due regard for the rights
of all parties as well as the facts, the law, and the need for prompt
and orderly dispatch of public business.
The provision for affidavits of bias or personal disqualification
requires a decision thereon by the agency in, and as a part of, the
case; it thereby becomes subject to administrative and judicial
review. That decision might be made upon the affidavit alone, as
for example, the protest might be dismissed as insufficient on its
face. The agency itself may hear any relevant argument or facts,
or it may designate an examiner to do so. The effect which bias
or disqualification shown upon the record might have would be
determined by the ordinary rules of law and the other provisions
of this bill. If it appeared or were discovered late, it would have
the effect—where issues of fact or discretion were important and
the conduct and demeanor of witnesses relevant in determining
-------
STATUTES AND LEGISLATIVE HISTORY 839
them—of rendering the recommended decisions or initial deci-
sions of such officers invalid. This consequence will require agen-
cies and examiners themselves to take care that they do not sit
where subject to disqualification.
The term "presiding officers" means those who officially sit and
conduct the proceedings for reception of evidence. If more than
one so "presides," there may of course be a chairman who also
presides in a slightly different but familiar sense as chairman of
the presiding body.
SECTION 7 (B) . HEARING POWERS OF PRESIDING OFFICERS
Presiding officers, subject to the rules of the procedure adopted
by the agency and within its powers, have authority to (1) admin-
ister oaths, (2) issue such subpenas as are authorized by law, (3)
receive evidence and rule upon offers of proof, (4) take depositions
or cause them to be taken, (5) regulate the hearing, (6) hold con-
ferences for the settlement or simplification of issues, (7) dispose
of procedural requests, (8) make decisions or recommended deci-
sions under section 8 of the bill, and (9) exercise other authority
as provided by agency rule consistent with the remainder of the
Ml.
The section does not expand the powers of agencies. It assures
that the presiding officer or officers will perform a real function
rather than serve merely as notaries or policemen. They would
have and independently exercise all the powers listed in the section.
The agency itself—which must ultimately either decide the case,
consider reviewing it, or hear appeals from the examiner's deci-
sion—should not in effect conduct hearings from behind the scenes
where it cannot know the detailed happenings in the hearing room
and does not hear or see the witnesses or private parties.
SECTION 7 (C) . EVIDENCE REQUIREMENTS
Except as statutes otherwise provide, the proponent of a rule
or order has the burden of proof. While any evidence may be
received, as a matter of policy agencies are required to provide
for the exclusion of irrelevant, immaterial, or unduly repetitious
evidence and no sanction may be imposed or rule or order be
issued except upon consideration of the whole record or such por-
tions as any party may cite and as supported by and in accordance
[p. 35]
with reliable, probative, and substantial evidence. Any party may
present his case or defense by oral or documentary evidence, sub-
mit rebuttal evidence, and conduct reasonable cross-examination.
However, in the case of rule making or determining applications
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840 LEGAL COMPILATION—PESTICIDES
for initial licenses, the agency may adopt procedures for the sub-
mission of evidence in written form so far as the interest of any
party will not be prejudiced thereby.
That the proponent of a rule or order has the burden of proof
means not only that the party initiating the proceeding has the
general burden of coming forward with a prima facie case but
that other parties, who are proponents of some different result,
also for that purpose have a burden to maintain. Similarly the
requirement that no sanction be imposed or rule or order be issued
except upon evidence of the kind specified means that the propo-
nents of a denial of relief must sustain such denial by that kind
of evidence. For example, credible and credited evidence submit-
ted by the applicant for a license may not be ignored except upon
the requisite kind and quality of contrary evidence. No agency
is authorized to stand mute and arbitrarily disbelieve credible
evidence. Except as applicants for a license or other privilege may
be required to come forward with a prima facie showing, no agen-
cy is entitled to presume that the conduct of any person or status
of any enterprise is unlawful or improper. In other words, this
section means that every proponent of a rule or order or the denial
thereof has the burden of coming forward with sufficient evi-
dence therefor; and in determining applications for licenses or
other relief any fact, conduct, or status so shown by credible and
credited evidence must be accepted as true except as the contrary
has been shown or such evidence has been rebutted or impeached
by duly credited evidence or by facts officially noticed and stated.
The second and primary sentence of the section is framed on
the premise that, as to the admissibility of evidence, an adminis-
trative hearing is to be compared with an equity proceeding in the
courts. Thus, the mere admission of evidence is not to be taken as
prejudicial error (there being no lay jury to be protected from
improper influence) although irrelevant, immaterial, and unduly
repetitious evidence is useless and is to be excluded as a matter of
efficiency and good practice; and no finding or conclusion may be
entered except upon consideration by the agency of the whole
record or so much thereof as a party may cite and as supported
by and in accordance with evidence which is plainly of the requi-
site relevance and materiality—that is, "reliable, probative, and
substantial evidence." Thus while the exclusionary "rules of evi-
dence" do not apply except as the agency may as a matter of sound
practice simplify the hearing and record by excluding improper
or unnecessary matter, the accepted standards and principles of
probity, reliability, and substantiality of evidence must be applied.
-------
STATUTES AND LEGISLATIVE HISTORY 841
These are standards or principles usually applied tacitly and rest-
ing mainly upon common sense which people engaged in the con-
duct of responsible affairs instinctively understand. But they exist
and must be rationally applied. They are to govern in administra-
tive proceedings. These requirements do not preclude the admis-
sion of or reliance upon technical reports, surveys, analyses, and
summaries where appropriate to the subject matter.
[p. 36]
The first and second sentences of the section therefore mean
that, where a party having the burden of proceeding has come
forward with a prima facie and substantial case, he will prevail
unless his evidence is discredited or rebutted. In any case the
agency must decide "in accordance with the evidence." Where
there is evidence pro and con, the agency must weigh it and
decide in accordance with the preponderance. In short, these pro-
visions require a conscientious and rational judgment on the
whole record in accordance with the proofs adduced. The proof
must be substantial, as provided in this section and also in sec-
tion 10 (e) where the term "substantial evidence" is discussed
later in this report.
The provision on its face does not confer a right of so-called
"unlimited" cross-examination. Presiding officers will have to
make the necessary initial determination whether the cross-exam-
ination is pressed to unreasonable lengths by a party or whether
it is required for the "full and true disclosure of the facts" stated
in the provision. Nor is it the intention to eliminate the authority
of agencies to confer sound discretion upon presiding officers in
the matter of its extent. The test is—as the section states—
whether it is required "for a full and true disclosure of the facts."
In many rule-making proceedings where the subject matter and
evidence are broadly economic or statistical in character and the
parties or witnesses numerous, the direct or rebuttal evidence may
be of such a nature that cross-examination adds nothing substan-
tial to the record and unnecessarily prolongs the hearings. The
right of cross-examination extends, in a proper case, to written
evidence submitted pursuant to the last sentence of the section as
well as to cases in which oral or documentary evidence is received
in open hearing. Even in the latter case, subject to the appropriate
safeguards, technical data may as a matter of convenience be
reduced to writing and introduced as in courts. Among these are
technical statements, reports of surveys, analyses, and summa-
ries. The written evidence provision of the last sentence of the
section is designed to cover situations in which, as a matter of
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842 LEGAL COMPILATION—PESTICIDES
general rule or practice, the submission of the whole or substan-
tial portions of the evidence in a case is done in written form. In
those situations, however, the provision limits the practice to spec-
ified classes of cases and, even then, only where and to the extent
that "the interest of any party will not be prejudiced thereby."
To the extent that cross-examination is necessary to bring out the
truth, the party must have it. An adequate opportunity must also
be provided for a party to prepare and submit appropriate rebut-
tal evidence.
Agencies must comply fully and the courts, pursuant to section
10 of the bill, must enforce all of these requirements diligently.
SECTION 7 (D). RECORD OP HEARINGS
The record of evidence taken and papers filed is exclusive for
decision and, upon payment of costs, is available to the parties.
Where decision rests on official notice of a material fact not
appearing in the evidence of record, any party may on timely
request show the contrary.
The "official notice" mentioned relates to the administrative
practice of taking facts as shown and true though not in the
record. This is done by analogy to "judicial notice" familiar in
court procedure. Where agencies take such notice they must so
state on the record or in their decisions and then afford the parties
[P. 37]
an opportunity to show the contrary. But such notice may initially
be taken only of generally recognized and ordinarily indisputable
facts—usually those of a scientific or public nature.
SECTION 8. AGENCY DECISIONS AFTER HEARING
Section 8 applies to cases in which a hearing is required to be
conducted pursuant to section 7.
Like section 7, upon which section 8 depends, this section is sup-
plementary to sections 4 and 5 in cases in which agency action is
required to be taken after hearing provided by statute and not
otherwise expressly excepted. The decision in formal proceedings
is exceedingly important, because most criticisms of the adminis-
trative process relate in one way or another to the methods
whereby agencies decide cases. There are suspicions and good
ground for assuming that those who purport to decide cases actu-
ally do not, that the submittals of private parties are not fully
considered, that the views of agency personnel are emphasized
without opportunity for private parties to meet them, and that
matters outside the record are often the real grounds of decision.
-------
STATUTES AND LEGISLATIVE HISTORY 843
SECTION 8 (A). DECISIONS BY SUBORDINATES
Where the agency has not presided at the reception of the evi-
dence, the presiding officer (or any other officer) qualified to pre-
side, in cases exempted from section 5 (c)) must make the initial
decision unless the agency—by general rule or in a particur case
—undertakes to make the initial decision. If the presiding officer
makes the initial decision, it becomes the decision of the agency in
the absence of an appeal to the agency or review by the agency on
its own motion. On such appeal or review by the agency on its own
motion. On such appeal or review, the agency has all the powers it
would have had in making the initial decision. If the agency makes
the initial decision without having presided at the taking of the
evidence, whatever officer took the evidence must first make a
recommended decision except that, in rule making or determining
applications for initial licenses, (1) the agency may instead issue
a decision or (2) such intermediate procedure may be wholly
omitted in any case in which the agency finds on the record that the
execution of its functions imperatively and unavoidably so requires.
These provisions are mandatory but permit agencies to either
have their examiners make decisions or, as is now usually the case,
recommend decisions. In either case the examiner system is neces-
sary because agencies cannot themselves hear all cases. Where they
do not do so some device must be used to bridge the gap between
the officials who hear and those who decide cases. The provision
that on agency review of initial examiners' decisions it has all the
powers it would have had in making the initial decision itself does
not mean that initial examiners' decisions or recommended deci-
sions are without effect. They become a part of the record and are
of consequence, for example, to the extent that material facts in
any case depend on the determination of credibility of witnesses
as shown by their demeanor or conduct at the hearing. In a broad
sense the agencies' reviewing powers are to be compared with that
of courts under section 10 (e). r „ ,
[p. ooj
HEARINGS
Sec. 7. In hearings which section 4 or 5 requires to be conducted pursuant to
this section—
(a) PRESIDING OFFICERS.—There shall preside at the taking of evidence (1)
the agency, (2) one or more members of the body which comprises the agency,
or (3) one or more examiners appointed as provided in this Act; but nothing
in this Act shall be deemed to supersede the conduct of specified classes of pro-
ceedings in whole or part by or before boards or other officers specially pro-
vided for by or designated pursuant to statute. The functions of all presiding
officers and of officers participating in decisions in conformity with section 8
shall be conducted in an impartial manner. Any such officer may at any time
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844
LEGAL COMPILATION—PESTICIDES
withdraw if he deems himself disqualified; and, upon the filing in good faith
of a timely and sufficient affidavit of personal bias or disqualification of any
such officer, the agency shall determine the matter as a part of the record and
decision in the case.
(b) HEARING POWERS.—Officers presiding at hearings shall have authority,
subject to the published rules of the agency and within its powers, to (1)
administer oaths and affirmations, (2) issue subpenas authorized by law, (3)
rule upon offers of proof and receive evidence, (4) take or cause depositions
to be taken whenever the ends of justice would be served thereby, (5) regulate
the course of the hearing, (6) hold conferences for the settlement or sim-
plification of the issues by consent of the parties, (7) dispose of procedural
requests or similar matters, (8) make decisions or recommend decisions in
conformity with section 8, and (9) take any other action authorized by agen-
cy rule consistent with this Act.
(c) EVIDENCE.—Except as statutes otherwise provide, the proponent of a
rule or order shall have the burden of proof. Any [evidence] oral or documen-
tary evidence 15 may be received, but every agency shall as a matter of policy
provide for the exclusion of irrelevant,1* immaterial, [and] or unduly repeti-
tious evidence and no sanction shall be imposed or rule or order be issued
except upon consideration of the whole record or such portions thereof as may
be cited by any party and 17 as supported by and in accordance with the [rele-
vant] reliable, [and] probative, and substantial evidence.18 Every party
shall have the right to present his case or defense by oral or documentary
evidence, to submit rebuttal evidence, and to conduct such cross-examination
as may be required for a full and true disclosure of the facts. In rule making
or determining claims for money or benefits or applications for initial licenses
any agency may, where the interest of any party will not be prejudiced there-
by, adopt procedures for the submission of all or part of the evidence in writ-
ten form.
(d) RECORD.—The transcript of testimony and exhibits, together with all
papers and requests filed in the proceeding, shall constitute the exclusive
record for decision in accordance with section 8 and, upon payment of law-
fully prescribed costs, shall be made available to the parties. Where any agen-
cy decision rests on official notice of a material fact not appearing in the evi-
dence in the record, any party shall on timely request be afforded an oppor-
tunity to show the contrary.
15 The prior form involved an unnecessary
circumlocution of language.
16 The word "relevant" has been stricken
from the latter part of this sentence and the
word "irrelevant" has been inserted at this
point where it more appropriately belongs, to
achieve the same purpose.
17 That the whole of the relevant record
must be considered is the rule laid down in
section 10 (e) on judicial review, but some
hypercritical mind might contend that the
omission to specify such consideration at the
agency stage of proceedings was intentional
and meant that the agency is not required to
consider the whole record.
18 The insertion of the word "substantial"
is made for the same reason as the insertion
explained in note 17. Obviously the agency will
proceed in accordance with the evidence which
it finds reliable, probative, and substantial—
there is no reason why the bill should not say
so.
-------
STATUTES AND LEGISLATIVE HISTORY
845
1.7a (3) CONGRESSIONAL RECORD, VOL. 92 (1946)
1.7a (3) (a) March 12: Debated and passed Senate, pp. 2151,
2155-2159,2162,2165, 2167
other materials of administrative law.
Second. It states the essentials of
the several forms of administrative
proceedings and the limitations on ad-
ministrative 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. 2151]
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
Mr. McCARRAN.
*****
Now let me point out some of the es-
sential respects in which the pending
bill differs from the Walter-Logan bill.
The bill now before the Senate differ-
entiates the several types of rules. It
requires no agency hearings in connec-
tion with either regulations or ad-
judications unless statutes already do
so in particular cases, thereby preserv-
ing rights of individual trials de novo.
Where statutory hearings are other-
wise provided, this bill fills in some of
the essential requirements; and it pro-
vides for a special class of semi-inde-
pendent subordinate hearing officers.
* * * * *
I cannot emphasize too strongly that
the bill now before the Senate is not a
specification of the details of adminis-
trative procedure. Neither is it a codi-
fication of administrative law. It rep-
resents, instead, an outline of mini-
mum basic essentials, framed out of
long consideration and in the light of
the comprehensive studies I have pre-
viously mentioned.
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 determina-
tions. The jurisdiction of the courts is
clearly stated. The bill thus provides
for public information, administrative
operation, 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
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846
LEGAL COMPILATION—PESTICIDES
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 incor-
porate 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 hear-
ings and decisions thereon, apply in
place of the provisions of this sub-
section.
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 effective
date of such rule, except as otherwise
provided by the agency for good cause
found and published, or, in the case of
rules recognizing exemption or reliev-
ing restriction, interpretative 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.
Section 5 of the bill concerns adjudi-
cations. The initial provision of this
section makes it clear that subsequent
provisions of the section 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:
First, cases subject to trial de novo in
court; second, selection or tenure of
public officers other than examiners;
third, decisions resting on inspections,
tests, or elections; fourth, military,
naval, and foreign affairs functions;
fifth, cases in which an agency is act-
ing for a court; and, sixth, the certifi-
cation of employee representatives.
Subsection (a) of section 5 refers to
notice. Under this subsection, persons
entitled to notice of an agency hearing
are to be duly and timely informed of
the time, place, and nature of the hear-
ing, the legal authority and jurisdic-
tion under which it is to be held, and
the matters of fact and law asserted.
Where private persons are the moving
parties, respondents must give prompt
notice of issues controverted in law or
fact; and in other cases the agency may
require responsive pleading. In fixing
the times and places for hearings the
agency must give due regard to the
convenience and necessity of the par-
ties.
Subsection (b) of section 5 concerns
procedure. Under this subsection the
agency is required first to afford par-
[p. 2155]
ties an opportunity for the settlement
or adjustment of issues, where time,
the nature of the proceeding, and the
public interest permit; and then re-
quires that such opportunity for settle-
ment or adjustment be followed, to the
extent that issues are not so settled or
adjusted, by hearing and decision un-
der sections 7 and 8.
[p. 2156]
Section 7 concerns hearings and ap-
plies only where hearings are required
by section 4 or 5.
Subsection (a) of section 7 provides
that the hearing must be held either by
the agency, a member or members of
the board which comprises it, one or
more examiners, or other officers spe-
cially provided for in other statutes or
designated by other statutes. All pre-
siding and deciding officers are to
operate impartially. They may at any
time withdraw if they deem themselves
disqualified; and, upon the filing of a
proper affidavit of personal bias or dis-
qualification against them, the agency
is required to determine the matter as
a part of the record and decision in
the case.
Subsection (b) of section 7 concerns
hearing powers. It provides that pre-
siding officers, subject to the rules of
-------
STATUTES AND LEGISLATIVE HISTORY
847
procedure adopted by the agency and
within its powers, have authority as
follows: First, to administer oaths;
second, to issue such subpenas as are
authorized by law; third, to receive
evidence and rule upon offers of proof;
fourth, to take depositions or cause dep-
ositions to be taken; fifth, to regulate
the hearing; sixth, to hold conferences
for the settlement or simplification of
the issue; seventh, to dispose of pro-
cedural requests; eighth, to make de-
cisions or recommended decisions under
section 8 of the bill; and, ninth, to
exercise other authority as provided by
agency rule consistent with the re-
mainder of the bill.
Subsection (c) of section 7 relates to
evidence. It provides that except as
statutes otherwise provide, the propo-
nent of a rule or order has the burden
of proof. While any evidence may be
received, as a matter of policy agencies
are required to provide for the exclu-
sion of irrelevant and unduly repeti-
tious evidence, and no sanction may be
imposed, or rule or order issued, except
as supported by relevant, reliable, and
probative evidence. Any party may
present his case or defense by oral or
documentary evidence, may submit
rebuttal evidence, and may conduct
reasonable cross-examination. How-
ever, in the case of rule making or
determining applications for initial
licenses, the agency may adopt pro-
cedures for the submission of evidence
in written form so far as the interest
of any party will not be prejudiced
thereby.
Mr. AUSTIN. Mr. President, at that
point I wish the Senator from Nevada
would yield for a question.
Mr. McCARRAN. I gladly yield to
the Senator from Vermont.
Mr. AUSTIN. Did the committee in-
tentionally choose the language "ex-
cept as supported by relevant, reliable,
and probative evidence" in order to
avoid the rule of scintilla of proof?
This phrase is very significant, as I
see it. On review, for example, the case,
in order to carry through as decided
by the agency, would have to be sup-
ported by relevant, reliable, and pro-
bative evidence. That is, in my opinion,
a very important forward step in ju-
dicial procedure, to say nothing about
administrative procedure. For my part
I am glad to see it in the bill.
Mr. McCARRAN. Let me say to the
Senator from Vermont that in the
preparation of this bill many obstacles
were encountered. Some of us insisted
that the testimony must be relevant,
material, and competent, and that
nothing else should be taken. However,
representatives of agencies came be-
fore us and presented their views, say-
ing that such a rule would curtail their
operations, and that they ought to be
given greater latitude. They said to
us, "We are not lawyers." We are
acting in a quasi-judicial capacity. We
ought to be able to go outside and get
hearsay testimony, if you please. We
might be able to indulge in theory." So
rather than curtail the agencies, we
sought an intermediate ground which
we thought would be protective of the
rights of individuals, and at the same
time would not handicap the agencies.
So we said to them, "You may go out-
side and get what would be secondary
evidence, or hearsay; you may perhaps
even go into the realm of conjecture;
but when you write your decision it
must be based upon probative evidence
and nothing else. If in the formation of
your decision you consider other than
probative evidence, your decision will
be subject to being set aside by a court
of review."
In other words, we did not wish to
destroy the administrative agencies or
prescribe the methods under which
they have been operating. Some of us
know that in committees of the Senate
we very frequently hear evidence
which we know is hearsay. I doubt very
much if any hearing is ever conducted
in which, to some extent, hearsay is
not admitted. But we believed, and we
now believe, that reasonable men can
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848
LEGAL COMPILATION—PESTICIDES
sift the grain from the chaff. Then we
laid down the rule that the administra-
tive agencies must not make a finding
which impinges upon an individual
unless there is behind such finding
probative evidence to sustain it. That
is what we have worked out in this bill.
I have given the explanation at some
length in answer to the Senator from
Vermont.
Mr. FERGUSON. Mr. President,
will the Senator yield?
Mr. McCARRAN. I yield.
Mr. FERGUSON. Would the Sen-
ator, then, say that the judgment or
decision of the agency must be based
upon stronger proof than a scintilla of
evidence?
Mr. McCARRAN. Very much
stronger.
Mr. FERGUSON. The old rule
which applied in the courts, particu-
larly on certiorari, was that if there
was any evidence to sustain the verdict
or judgment, it should be sustained.
The courts have many times so held.
The Senator would say, would he not,
that something more than "any evi-
dence" is required to sustain such a
decision.
Mr. McCARRAN. The answer is in
the affirmative. We say that the evi-
dence must be substantial probative
evidence.
Mr. FERGUSON, So we are chang-
ing the rule which has been applied in
the past that any evidence, or a scin-
tilla of evidence, as it is sometimes
defined, is sufficient to sustain a verdict
or judgment.
Mr. McCARRAN. We tried as best
we could to establish a guide for ad-
ministrative groups so that they would
apply the rule in such a way that there
would be substantial probative evi-
dence behind their findings, and so that
they could say, "We are not afraid to
have our findings reviewed by a court."
Mr. GEORGE. Mr. President, will
the Senator yield?
Mr. McCARRAN. I yield.
Mr. GEORGE. The courts have
many times held that if there is any
evidence to sustain the finding of an
administrative board under the stat-
ute, the courts have no power to inter-
vene. If this bill should become a law
would that rule, as heretofore con-
strued by the courts, remain in effect?
Mr. McCARRAN. The courts have
given various constructions. The
[p. 2157]
courts, in reviewing an order, are gov-
erned by the provisions of section 10
(e), which states the substantial-evi-
dence rule. In other words, in some
instances the courts have held that
there must be substantial evidence. We
are saying that there must be probative
evidence of a substantial nature, and
that even though the commission or
bureau may take hearsay evidence in
its hearings, it must have some proba-
tive evidence to sustain its finding.
Mr. GEORGE. The point I wish to
raise is that some of the acts of Con-
gress, particularly those enacted in re-
cent years, have led the courts to
hold—and they so hold—that if there
be any evidence to sustain the finding
of a board or agency, the court has no
power to interfere with it.
Mr. McCARRAN. I would put it in
this way—
Mr. GEORGE. Would the enactment
of this bill require some substantial or
probative evidence to support such a
finding?
Mr. McCARRAN. Yes.
Mr. GEORGE. Take the labor rela-
tions cases. Senators are familiar with
them. The circuit courts have fre-
quently complained against what the
Labor Relations Board did, but have
said, "We are powerless to interfere
with it." Would this bill change that
rule, if the court were of the opinion
that there was no probative evidence?
Mr. McCARRAN. Yes; it would
change that rule.
Mr. GEORGE. I am pleased to hear
it.
Mr. McCARRAN. I thank the Sen-
ator.
-------
STATUTES AND LEGISLATIVE HISTORY
849
Subsection (d) of section 7 provides
that the record of evidence taken and
papers filed is exclusive for decision,
and, upon payment of costs, is avail-
able to the parties. Where decision
rests on official notice of a material
fact not appearing in the evidence of
record, any party may on timely re-
quest show the contrary.
Section 8 relates to decisions, and
applies to cases in which a hearing is
required to be conducted pursuant to
section 7.
Subsection (a) of section 8 relates
to action by subordinates. It provides
that where the agency has not presided
at the reception of the evidence, the
presiding officer, or any other officer
qualified to preside, in cases exempted
from subsection (c) of section 5, must
make the initial decision unless the
agency, by general rule or in a par-
ticular case, undertakes to make the
initial decision. If the presiding officer
makes the initial decision, it becomes
the decision of the agency in the ab-
sence of an appeal to the agency or
review by the agency on its own mo-
tion. On such appeal or review, the
agency has all the powers it would
have had in making the initial decision.
If the agency makes the initial deci-
sion without having presided at the
taking of the evidence, whatever officer
took the evidence must first make a,
recommended decision, except that, in
rule making or determining applica-
tions for initial licenses, the agency
may instead issue a tentative decision
or any of its responsible officers may
recommend a decision, or such inter-
mediate procedure may be wholly
omitted in any case in which the agency
finds on the record that the execution
of its functions imperatively and un-
avoidably requires.
Subsection (b) of section 8 concerns
submittals and decisions. It provides
that prior to each recommended or
other decision or review, the parties
must be given an opportunity to submit
for the full consideration of deciding
officers, first, proposed findings and
conclusions, or exceptions to recom-
mended decisions or other decisions
being appealed or reviewed; and, sec-
ond, supporting reasons for such find-
ings, conclusions, or exceptions. All
recommended or other decisions be-
come a part of the record and must
include findings and conclusions, as
well as the basis therefor, upon all the
material issues of fact, law, or discre-
tion presented by the record, besides
including the appropriate agency ac-
tion or denial.
Section 9 concerns sanctions and
powers, and relates to the exercise of
any power or authority by an agency.
Unlike sections 7 and 8, section 9
applies in all relevant cases, regardless
of whether the agency is required by
statute to proceed upon hearing or in
any special manner. Section 9 also ap-
plies to any power or authority that an
agency may assume to exercise.
*****
[p. 2158]
That completes the synopsis of the
bill.
Mr. President, as I have pointed out
before, this bill is designed to operate
as a whole, and its provisions are close-
ly interrelated. At the same time, it
should be pointed out that there are
certain provisions which touch upon
subjects long regarded as of the high-
est importance. On some of these sub-
jects, such as the separation of ex-
aminers from the agencies they serve,
there has been a wide divergence of
views. The committee has, in such
cases, taken the course which it be-
lieves will suffice, without being exces-
sive. Amendatory or supplementary
legislation can supply any deficiency
which experience discloses in such
cases. The committee believes that spe-
cial note should be made of these
situations:
The exemption of rule making and
determining applications for licenses,
from provisions of sections 5 (c), 7
(c), and 8 (a) may require change if,
-------
850
LEGAL COMPILATION—PESTICIDES
in practice, it develops that they are
too broad. The committee believes it
has followed sound discretion in selec-
tion of the language used, and it is the
feeling of the committee that, where
cases present sharply contested issues
of fact, agencies should not as a mat-
ter of good practice take advantage of
the exemptions.
The committee has considered the
possibility that the preservation in sec-
tion 7 (a) of the "conduct of specified
classes of proceedings in whole or part
by or before boards or other officers
specially provided for by or designated
pursuant to statute" might prove to be
a loophole for avoidance of the exam-
iner system. If experience should prove
this true in any real sense, corrective
legislation would be or might be neces-
sary. Therefore, the committee desires
that Government agencies should be
put on notice that the provision in
question is not intended to permit
agencies to avoid the use of examiners,
but only to preserve special statutory
types of hearing officers who contribute
something more than examiners could
contribute, and at the same time to
assure the parties fair and impartial
procedure.
The basic provision respecting evi-
dence, in section 7 (c)—the provision
requiring that any agency action must
be supported by plainly "relevant, re-
liable, and probative evidence"—will
require full compliance by agencies,
and diligent enforcement by reviewing
courts, and so forth. Should the lan-
guage prove insufficient to fix and
maintain the standards of proof, sup-
plemental legislation will become nec-
essary. That is another matter which,
at the outset of legislation such as this
must depend upon the spirit in which
the agencies attempt to comply fully
with the law. The committee antici-
pates nothing less than full compliance
and adequate enforcement; and, with
such compliance and enforcement, the
committee believes that the language
in question will be adequate.
[p. 2159]
Section 7 contains provisions relating to deci-
sions for the initial submission of briefs, pro-
posed findings and conclusions, and oral argu-
ment for consideration in preparing an initial
decision, or where subordinate officers preside,
an intermediate report, the details of such re-
port or decision, provisions for administrative
review, the consideration of cases, the findings
and opinions and the service thereof upon all
the parties.
The provisions of these two sections on fair
hearings and findings or decisions should serve
to meet most of the heated criticisms heretofore
directed against administrative agencies in the
conduct of hearings. Most well-run agencies
have already provided for such procedures.
[p. 2162]
HEARINGS
SBC. 7. In hearings which section 4 or 6 re-
quires to be conducted pursuant to this section—
(a) Presiding officers: There shall preside at
the taking of evidence (1) the agency (2) one
or more members of the body which comprises
the agency, or (3) one or more examiners ap-
pointed as provided in this act; but nothing in
this act shall be deemed to supersede the conduct
of specified classes of proceedings in whole or
part by or before boards or other officers spe-
cially provided for by or designated pursuant
to statute. The functions of all presiding offi-
cers and of officers participating in decisions in
conformity with section 8 shall be conducted in
an impartial manner. Any such officer may at
any time withdraw if he deems himself dis-
qualified ; and, upon the filing in good faith of
a timely and sufficient affidavit of personal bias
or disqualification of any such officer, the
agency shall determine the matter as a part of
the record and decision in the case.
(b) Hearing powers-. Officers presiding at
hearings shall have authority, subject to the
published rules of the agency and within its
powers to (1) administer oatha and affirmations,
(2) issue subpenas authorized by law (3) rule
upon offers of proof and receive relevant evi-
dence, (4) take or cause depositions to be taken
whenever the ends of justice would be served
thereby, (5) regulate the course of the hearing,
(6) hold conferences for the settlement or
simplification of the issues by consent of the
parties, (1) dispose of procedural requests or
similar matters, (8) make decisions or recom-
mend decisions in conformity with section 8
and (9) take any other action authorized by
agency rule consistent with this act.
(c) Evidence: Except as statutes otherwise
provide, the proponent of a rule or order shall
have the burden of proof. Any evidence, oral or
documentary, may be received but every agency
shall as a matter of policy provide for the ex-
clusion of immaterial and unduly repetitious
-------
STATUTES AND LEGISLATIVE HISTORY
851
evidence and no sanction shall be imposed or
rule or order be issued except as supported by
relevant, reliable, and probative evidence. Every
party shall have the right to present his case
or defense by oral or documentary evidence, to
submit rebuttal evidence, and to conduct such
cross-examination as may be required for a full
and true disclosure of the facts. In rule making
or determining claims for money or benefits or
applications for initial licenses any agency may,
where the interest of any party will not be prej-
udiced thereby, adopt procedures for the sub-
mission of all or part of the evidence in written
form.
(d) Record: The transcript of testimony and
exhibits, together with all papers and requests
filed in the proceeding, shall constitute the
exclusive record for decision in accordance with
section 8 and, upon payment of lawfully pre-
scribed costs, shall be made available to the
parties. Where any agency decision rests on
official notice of a material fact not appearing
in the evidence in the record, any party shall
on timely request be afforded an opportunity
to show the contrary.
[p. 2165]
The amendment was agreed to.
The PRESIDING OFFICER. The
question is on the engrossment and the
third reading of the bill.
The bill (S. 7) was ordered to be en-
grossed for a third reading, read the
third time, and passed.
[p. 2167]
1.7a (3) (b) May 24: Debated, amended and passed House, pp.
5645, 5649, 5652-5653,5655,5665,5668
prescribing fair administrative proce-
dure. The rule is an open rule, and
provides 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 about real justice to all
those who are obliged to face our
courts.
ADMINISTRATIVE PROCEDURE
ACT
Mr, SABATH. Mr. Speaker, I call
up House Resolution 615 and ask for
its immediate consideration.
The Clerk read the resolution, as
follows:
Resolved, 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 5-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
PUBLICITY VALUABLE CONTRIBUTION
There is general agreement that the
present bill has not only eliminated
the objections previously made but has
achieved a substantial contribution in
its publicity requirements; and that it
has arrived at an equitable and helpful
differentiation of the legislative or
rule-making powers and the quasi-
judicial powers frequently lodged in
the same agency.
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 several forms of administrative
proceedings and the general limita-
tions on administrative powers.
Third. It provides in more detail the
requirements for administrative hear-
-------
852
LEGAL COMPILATION—PESTICIDES
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,
promulgate statements respecting their
procedures, and make available as
regulations the substantive and inter-
pretative 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
relates to the legislative functions of
administrative 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
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.
Section 6 deals with the investigative
powers and other incidental matters
of importance.
In the all-important field of judicial
review section 10 is a complete state-
ment of the subject. It prescribes
briefly when there may be judicial re-
view and how far the courts may go in
examining into a given case.
IV. DETAILED PROVISIONS
In taking up the specific provisions
of the bill as reported to the House, I
will not attempt to restate all of the
detail which appears in the committee
report at pages 18 to 48. I shall try,
however, to emphasize those things
which are of paramount importance
and at the same time state how the
provisions of the bill as a whole are
intended to operate.
[p. 5649]
HEARINGS, SECTION 7
It will be recalled that section 4—
relating to rule making—and section
5—relating to the determination of
particular cases—refer to situations in
which Congress has by some other stat-
ute required an agency to act upon a
hearing. Accordingly sections 7 and 8,
which I am about to discuss, state the
requisites of statutory agency hearings
and decisions.
PRESIDING OFFICERS, SECTION 7 (A)
The first subsection of section 7 re-
quires an agency to hold hearings it-
self, or through a member or members
of the board which comprises it, or by
one or more examiners qualified as
provided in section 11 of the bill, or
through other officers specially pro-
vided for or designated pursuant to
the authority contained in other stat-
utes. Whoever presides must do so
impartially. They may withdraw if
they deem themselves disqualified or,
if an affidavit of personal bias or dis-
qualification is filed against them, the
agency must determine the issue as a
part of the record and decision in the
case.
This provision authorizes agencies,
if they do not wish to hear cases them-
selves, to delegate the hearing function
-------
STATUTES AND LEGISLATIVE HISTORY
853
to the named types of presiding officers.
It does not mean, however, that agen-
cies are authorized—whether pursuant
to the express authority of other stat-
utes or not—to avoid the examiner
system—set up in this bill and here-
after discussed— by assigning general
employees or attorneys to hear cases
individually or as boards. In short,
unless the agency or its members or
some specially qualified statutory offi-
cer hears the case, an examiner quali-
fied under section 11 of this bill must
do so.
Of particular importance in this sub-
section is the requirement that any
presiding officer must act impartially
rather than as a prosecutor. These
provisions mean that presiding officers
will be required to conduct themselves
in the manner in which people think
they should—that is, as judges and not
as the representatives of factions or
special interests.
HEARING POWERS, SECTION 7 (B)
Subsection (b) of section 7 lists the
commonly accepted kinds of powers
which it is generally conceded that
officers who preside at hearings ought
to have. These include administering
oaths, issuing authorized subpenas,
receiving or excluding evidence, taking
depositions, generally regulating the
hearing, holding informal conferences
with the parties for the settlement or
simplification of issues, disposing of
procedural requests such as those for
adjournment, and the like. In exercis-
ing these powers, of course, presiding
officers will be bound by relevant legal
limitations.
EVIDENCE, SECTION 7 (C)
Subsection (c) of section 7 is one of
the more important provisions of the
bill. In its final report the Attorney
General's Committee on Administra-
tive Procedure stated that—pages 70-
71:
Although administrative agencies may be
freed from observance of strict common-law
rules of evidence for jury trials, it is erroneous
to suppose that agencies do not, as a result, ob-
serve some rules of evidence. * * * Abuses
in admitting remote hearsay and irrelevant
or unreliable evidence there surely have
been. * « * That strict adherence to stan-
dards of relevance and probative value should
be observed needs no underscoring. A diffuse
record dissipates the energies of the parties and
the deciding authorities and distracts attention
from the issues. Careless admission of evidence
for what it is worth—a practice not infrequent
among trial examiners—swells the record be-
vond its necessary limits.
Section 7 (c) of this bill provides
that the proponent of a rule or order
has the burden of proof except as stat-
utes otherwise provide. It authorizes
agencies to receive any evidence, al-
though as a matter of policy they are
required to provide for the exclusion of
irrelevant, immaterial, or unduly repe-
titious matter. Thus, the mere fact
that such matter is in the record would
not of itself be reversible error. The
principal provision of the subsection
provides that no sanction may be im-
posed or rule or order be issued except
upon consideration of the whole record
or such portions as any party may cite
and as supported by and in accordance
with reliable, probative, and substan-
tial evidence. The parties are author-
ized to present documentary, oral, and
rebuttal evidence and to conduct rea-
sonable cross-examination. In rule
making or determining applications
for initial licenses agencies may adopt
procedures for the submission of the
evidence in written form, so far as the
interest of any party will not be prej-
udiced thereby.
The requirement that agencies may
act only upon relevant, probative, and
substantial evidence means that the ac-
cepted standards of proof, as distin-
guished from the mere admissibility of
evidence, are to govern in administra-
tive proceedings as they do in courts
of law and equity. The same provision
contains two other limitations-—first,
that the agency must examine and con-
sider the whole of the evidence relevant
to any issue and, secondly, that it must
decide in accordance with the evidence.
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854
LEGAL COMPILATION—PESTICIDES
Under these provisions the function of
an administrative agency is clearly not
to decide arbitrarily or to act contrary
to the evidence or upon surmise or
suspicion or untenable inference. Mere
uncorroborated hearsay or rumor does
not constitute substantial evidence—
see Edison Co. v. Labor Board (305
U. S. 197, 230). Under this provision
agencies are not authorized to decide
in accordance with preconceived ideas
or merely to sustain or vindicate prior
administrative action, but they must
enter upon a bona fide consideration of
the record with a view to reaching a
just decision upon the whole of it.
RECORD, SECTION 7 (D)
The final subsection of section 7 pro-
vides that the record of the evidence
taken and the papers filed is exclusive
for purposes of decision. It also pro-
vides that, where a decision rests in
whole or part on official notice of a
material fact not appearing in the rec-
ord, any party must on timely request
be given an adequate opportunity to
show the true facts.
Both of these provisions are impor-
tant. The exclusiveness of the record
precludes deciding officers from basing
their judgments as to the facts upon
matters which are not in the record.
The provision respecting official notice
is essential in order to prevent mis-
carriages of justice through mistake or
by unwarranted expansion of the idea
of judicial notice.
[p. 5653]
EXAMINERS, SECTION 11
One of the most controversial pro-
posals in the field of administrative
law relates to the status and indepen-
dence of examiners who hear cases
where agencies themselves or members
of boards cannot do so. I have hereto-
fore referred to this problem in my
discussion of section 8 respecting deci-
sions. Both sections 7 and 8 authorize
the use of examiners. Section 11, which
I am about to discuss, provides for
their selection, tenure, and compensa-
tion.
* * * * *
CONSTRUCTION AND EFFECT, SECTION 12
The final section of the bill provides
that nothing in it is to diminish con-
stitutional or other legal rights, that
requirements of evidence and proced-
ure are to apply equally to agencies
and private persons, that the unconsti-
tutionality of any portion or applica-
tion of the bill shall be subject to the
usual saving provision, and that sub-
sequent legislation is not to be deemed
to modify the bill except as it may do
so expressly.
The final sentence provides that the
bill shall become law 3 months after its
approval, except that sections 7 and 8
respecting statutory hearings and de-
cisions shall not take effect until 6
months after its approval, the require-
ments of section 11 respecting the se-
lection of examiners are not to become
effective for a year, and no require-
ment of the bill is mandatory as to any
agency proceeding initiated prior to
the effective date of such requirement.
The staggered effective date provi-
sion has been thought necessary in
order to give administrative agencies
every opportunity to prepare fully.
V. CONCLUSION
This measure is the culmination of
long and earnest consideration. It re-
sponds to a widespread, deep-seated,
and insistent public demand for some
attention to the problem of administra-
tive justice and administrative opera-
tions. It has been drafted with the
greatest of care and upon fulsome con-
sideration of views from every side. It
is not, of course, the final word, but it
is a good beginning.
[p. 5655]
"HEARINGS
"SEC. 7. In hearings which section 4 or 5 re-
quires to be conducted pursuant to this section—
"(a) Presiding officers: There shall preside at
the taking of evidence (!) the agency, (2) one
or more members of the body which comprises
-------
STATUTES AND LEGISLATIVE HISTORY
855
the agency, or (3) one or more examiners ap-
pointed as provided in this act; but nothing in
this act shall be deemed to supersede the conduct
of specified classes of proceedings in whole or
part by or before boards or other officers spe-
cially provided for by or designated pursuant to
statute. The functions of all presiding officers
and of officers participating in decisions in con-
formity with section 8 shall be conducted in an
impartial manner. Any such officer may at any
time withdraw if he deems himself disqualified ;
and, upon the filing in good faith of a timely
and sufficient affidavit of personal bias or dis-
qualification of any such officer, the agency
shall determine the matter as a part of the rec-
ord and decision in the case.
"(b) Hearing powers: Officers presiding at
hearings shall have authority, subject to the
published rules of the agency and within its
powers, to (1) administer oaths and affirma-
tions, (2) issue subpenas authorized by law, (3)
rule upon offers of proof and receive relevant
evidence, (4) take or cause depositions to be
taken whenever the ends of justice would be
served thereby, (5) regulate the course of the
hearing, (6) hold conferences for the settlement
or simplification of the issues by consent of the
parties, (7) dispose of procedural requests or
similar matters, (8) make decisions or recom-
mend decisions in conformity with section 8,
and (9) take any other action authorized by
agency rule consistent with this act.
"(c) Evidence: Except as statutes otherwise
provide, the proponent of a rule or order shall
have the burden of proof. Any oral or docu-
mentary evidence may be received, but every
agency shall as a matter of policy provide for the
exclusion of irrelevant, immaterial, or unduly
repetitious evidence and no sanction shall be
imposed or rule or order be issued except upon
consideration of the whole record or such por-
tions thereof as may be cited by any party and
as supported by and in accordance with the
reliable, probative, and substantial evidence.
Every party shall have the right to present his
case or defense by oral or documentary evidence,
to submit rebuttal evidence, and to conduct
such cross-examination as may be required for
a full and true disclosure of the facts. In rule
making or determining claims for money or
benefits or applications for initial licenses any
agency may, where the interest of any party
will not be prejudiced thereby, adopt procedures
for the submission of all or part of the evidence
in written form.
"(b) Record: The transcript of testimony
and exhibits, together with all papers and re-
quests filed in the proceeding, shall constitute
the exclusive record for decision in accordance
with section 8 and, upon payment of lawfully
prescribed costs, shall be made available to the
parties. Where any agency decision rests on
official notice of a material fact not appearing
in the evidence in the record, any party shall
on timely request be afforded an opportunity to
show the contrary.
[p. 5665]
The CHAIRMAN. Under the rule,
the Committee rises.
Accordingly the Committee rose;
and the Speaker having resumed the
chair, Mr. SMITH of Virginia, Chair-
man of the Committee of the Whole
House on the State of the Union, re-
ported that that Committee having had
under consideration the bill (S. 7) to
improve the administration of justice
by prescribing fair administrative
procedure, pursuant to House Resolu-
tion 615, he reported the bill back to
the House with an amendment adopted
by the Committee of the Whole.
The SPEAKER. Under the rule, the
previous question is ordered.
The question is on the amendment.
The amendment was agreed to.
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 bill was passed.
A motion to reconsider was laid on
the table.
[p.5668]
1.7a (3) (c) May 27: Senate concurs in House amendment, p. 5790
Mr. McCARRAN. Mr. President,
some weeks ago the Senate passed Sen-
ate bill No. 7, which is known as the
administrative procedure bill.
The Senator from Maine will recall
that the bill passed the Senate, after a
careful discussion, without a dissent-
ing vote. Let me say that the bill has
been under study and consideration for
nearly 10 years. For about 2 years,
while the present chairman of the Ju-
diciary Committee and other members
of that committee have had the matter
in hand, a very careful and meticulous
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856
LEGAL COMPILATION—PESTICIDES
study has been made of the whole sub-
ject. The House did not in any sub-
stantial particular amend the Senate
bill. The only thing which the House
did was to clarify the bill in respect to
a few of its provisions. I can best illus-
trate that by a brief statement from
the Attorney General as to what the
House did. Without quoting him at
length, the Attorney General said that
he approved the amendments which
had been made by the House which
were merely explanatory in nature.
For that reason, Mr. President, I
move that the Senate concur in the
House amendment. [p. 5790]
1.7b ADMINISTRATIVE PROCEDURE IN HEARINGS
AMENDMENTS
September 6,1966, P.L. 89-554, §556, 80 Stat. 386
§556. Hearings; presiding employees; powers and duties; burden
of proof; evidence; record as basis of decision
(a) This section applies, according to the provisions thereof, to
hearing's required by section 553 or 554 of this title to be conducted
in accordance with this section.
(b) There shall preside at the taking of evidence—
(1) the agency;
(2) one or more members of the body which comprises the
agency;or
(3) one or more hearing examiners appointed under sec-
tion 3105 of this title.
This subchapter does not supersede the conduct of specified classes
of proceedings, in whole or in part, by or before boards or other
employees specially provided for by or designated under statute.
The functions of presiding employees and of employees participat-
ing in decisions in accordance with section 557 of this title shall
be conducted in an impartial manner. A presiding or participating
employee may at any time disqualify himself. On the filing in good
faith of a timely and sufficient affidavit of personal bias or other
disqualification of a presiding or participating employee, the
agency shall determine the matter as a part of the record and deci-
sion in the case.
(c) Subject to published rules of the agency and within its pow-
ers, employees presiding at hearings may—
(1) administer oaths and affirmations;
(2) issue subpenas authorized by law;
(3) rule on offers of proof and receive relevant evidence;
(4) take depositions or have depositions taken when the
ends of justice would be served;
(5) regulate the course of the hearing;
(6) hold conferences for the settlement or simplification of
the issues by consent of the parties;
-------
STATUTES AND LEGISLATIVE HISTORY 857
(7) dispose of procedural requests or similar matters;
(8) make or recommend decisions in accordance with sec-
tion 557 of this title; and
(9) take other action authorized by agency rule consistent
with this subchapter.
(d) Except as otherwise provided by statute, the proponent of
a rule or order has the burden of proof. Any oral or documentary
evidence may be received, but the agency as a matter of policy
shall provide for the exclusion of irrelevant, immaterial, or unduly
repetitious evidence. A sanction may not be imposed or rule or
order issued except on consideration of the whole record or those
parts thereof cited by a party and supported by and in accordance
with the reliable, probative, and substantial evidence. A party is
entitled to present his case or defense by oral or documentary evi-
dence, to submit rebuttal evidence, and to conduct such cross-
examination as may be required for a full and true disclosure of
the facts. In rule making or determining claims for money or
[p. 386]
benefits or applications for initial licenses an agency may, when
a party will not be prejudiced thereby, adopt procedures for the
submission of all or part of the evidence in written form.
(e) The transcript of testimony and exhibits, together with all
papers and requests filed in the proceeding, constitutes the exclu-
sive record for decision in accordance with section 557 of this title
and, on payment of lawfully prescribed costs, shall be made availa-
ble to the parties. When an agency decision rests on official notice
of a material fact not appearing in the evidence in the record, a
party is entitled, on timely request, to an opportunity to show
the contrary.
[p. 387]
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858 LEGAL COMPILATION—PESTICIDES
1.7b (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.E. 10104]
The Committee on the Judiciary, to whom was referred the
bill (H.R. 10104) to enact Title 5, United States Code, "Govern-
ment 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, report favorably thereon without
amendment and recommend that the bill do pass.
PRELIMINARY STATEMENT
Purpose.—The purpose of this bill is to restate in comprehen-
sive form, without substantive change, the statutes in effect before
July 1, 1965, that relate to Government employees, the organiza-
tion and powers of Federal agencies generally, and administra-
tive procedure, and to enact title 5 of the United States Code. In
the revised title 5, simple language has been substituted for awk-
ward 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.
SECTION 556 Cp-1]
Derivation: United States Code Revised Statutes and Statutes at Large
5 U.S.C. 1006 June 11, 1946, ch 324, § 7, 60 Stat. 241.
In subsection (b), the words "hearing examiners" are substi-
tuted for "examiners" in paragraph (3) for clarity. The prohibi-
tion in the second sentence is restated in positive form and the
words "This subchapter does not" are substituted for "but noth-
ing in this chapter shall be deemed to." The words "employee"
and "employees" are substituted for "officer" and "officers" in
view of the definition of "employee" in section 2105. The sentence
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STATUTES AND LEGISLATIVE HISTORY 859
"A presiding or participating employee may at any time disqua-
lify himself." is substituted for the words "Any such officer may
at any time withdraw if he deems himself disqualified."
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. 13]
1.7b (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.E. 10104]
The Committee on the Judiciary, to which was referred the
bill (H.R. 10104), to enact title 5, United States Code, "Govern-
ment 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, hav-
ing considered the same, reports favorably thereon, with amend-
ments, and recommends that the bill, H.R. 10104, as amended,
do pass.
[P. IT
SECTION 556
Derivation: United States Code Revised Statutes and Statutes at Large
5 U.S.C. 1006 June 11,1946, ch. 324, § 7, 60 Stat. 241.
In subsection (b), the words "hearing examiners" are substi-
tuted for "examiners" in paragraph (3) for clarity. The prohibi-
tion in the second sentence is restated in positive form and the
words "This subchapter does not" are substituted for "but noth-
ing in this chapter shall be deemed to." The words "employee"
and "employees" are substituted for "officer" and "officers" in
view of the definition of "employee" in section 2105. The sen-
tence "A presiding or participating employee may at any time
disqualify himself." is substituted for the words "Any such officer
may at any time withdraw if he deems himself disqualified."
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860 LEGAL COMPILATION—PESTICIDES
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. 30]
1.7b(3) CONGRESSIONAL RECORD
1.7b (3) (a) VOL. Ill (1965), Sept. 7: Considered and passed
House, p. 22954
[No Relevant Discussion on Pertinent Section]
1.7b (3) (b) VOL. 112 (1966), July 25: Amended and passed
Senate, p. 17010
[No Relevant Discussion on Pertinent Section]
1.7b (3) (c) VOL. 112 (1966), Aug. 11: House concurs in Senate
amendments, p. 19077
[No Relevant Discussion on Pertinent Section]
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) (1)1
1.8a UNIFORM REVIEW, RECORDS AND ENFORCEMENT
ORDERS AMENDMENTS
August 28, 1958, P.L. 85-791, §2, 72 Stat. 941
AN ACT
To authorize the abbreviation of the record on the 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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, That the analy-
sis of chapter 133 of title 28 of the United States Code, immedi-
ately preceding section 2101 of such title, is amended by inserting
at the end thereof the following additional item:
"2112. Record on review and enforcement of agency orders."
"Sec. 2. Chapter 133 of title 28 of the United States Code is
amended by inserting at the end of such chapter immediately
following section 2111 an additional section, as follows:
"§2112. Record on review and enforcement of agency orders
"(a) The several courts of appeals shall have power to adopt,
with the approval of the Judicial Conference of the United States,
rules, which, so far as practicable, shall be uniform in all such
-------
STATUTES AND LEGISLATIVE HISTORY 861
courts prescribing the time and manner of filing and the con-
tents of the record in all proceedings instituted in the courts of
appeals to enjoin, set aside, suspend, modify, or otherwise review
or enforce orders of administrative agencies, boards, commissions,
and officers, to the extent that the applicable statute does not spe-
cifically prescribe such time or manner of filing or contents of the
record. Such rules may authorize the agency, board, commission,
or officer to file in the court a certified list of the materials com-
prising the record and retain and hold for the court all such mate-
rials and transmit the same or any part thereof to the court, when
and as required by it, at any time prior to the final determination
of the proceeding, and such filing of such certified list of the
materials comprising the record and such subsequent transmittal
of any such materials when and as required shall be deemed full
compliance with any provision of law requiring the filing of the
record in the court. The record in such proceedings shall be cer-
tified and filed in or held for and transmitted to the court of appeals
by the agency, board, commission, or officer concerned within the
time and in the manner prescribed by such rules. If proceedings
have been instituted in two or more courts of appeals with res-
pect to the same order the agency, board, commission, or officer
concerned shall file the record in that one of such courts in
which a proceeding with respect to such order was first instituted.
The other courts in which such proceedings are pending shall
thereupon transfer them to the court of appeals in which the
record has been filed. For the convenience of the parties in the
interest of justice such court may thereafter transfer all the pro-
ceedings with respect to such order to any other court of appeals.
" (b) The record to be filed in the court of appeals in such a
proceeding shall consist of the order sought to be reviewed, or
enforced, the findings or report upon which it is based, and the
pleadings, evidence, and proceedings before the agency, board,
commission, or officer concerned, or such portions thereof (1)
as the said rules of the court of appeals may require to be includ-
ed therein, or (2) as the agency, board, commission, or officer
concerned, the petitioner for review or respondent in enforce-
ment, as the case may be, and any intervenor in the court pro-
ceeding by written stipulation filed with the agency, board, com-
mission, or officer concerned or in the court in any such proceed-
ing may consistently with the rules of such court designate to be
[p. 941]
included therein, or (3) as the court upon motion of a party or,
after a prehearing conference, upon its own motion may by order
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862 LEGAL COMPILATION—PESTICIDES
in any such proceeding designate to be included therein. Such a
stipulation or order may provide in an appropriate case that no
record need be filed in the court of appeals. If, however, the cor-
rectness of a finding of fact by the agency, board, commission, or
officer is in question all of the evidence before the agency, board,
commission, or officer shall be included in the record except such
as the agency, board, commission, or officer concerned, the peti-
tioner for review or respondent in enforcement, as the case may
be, and any intervenor in the court proceeding by written stipu-
lation filed with the agency, board, commission, or officer con-
cerned or in the court agree to omit as wholly immaterial to the
questioned finding. If there is omitted from the record any por-
tion of the proceedings before the agency, board, commission, or
officer which the court subsequently determines to be proper for
it to consider to enable it to review or enforce the order in ques-
tion the court may direct that such additional portion of the pro-
ceedings be filed as a supplement to the record. The agency,
board, commission, or officer concerned may, at its option and
without regard to the foregoing provisions of this subsection, and
if so requested by the petitioner for review or respondent in
enforcement shall, file in the court the entire record of the pro-
ceedings before it without abbreviation.
"(c) The agency, board, commission, or officer concerned may
transmit to the court of appeals the original papers comprising
the whole or any part of the record or any supplemental record,
otherwise true copies of such papers certified by an authorized
officer or deputy of the agency, board, commission, or officer con-
cerned shall be transmitted. Any original papers thus transmitted
to the court of appeals shall be returned to the agency, board, com-
mission, or officer concerned upon the final determination of the
review or enforcement proceeding. Pending such final determina-
tion any such papers may be returned by the court temporarily to
the custody of the agency, board, commission, or officer concerned
if needed for the transaction of the public business. Certified cop-
ies of any papers included in the record or any supplemental
record may also be returned to the agency, board, commission, or
officer concerned upon the final determination of review or
enforcement proceedings.
"(d) The provisions of this section are not applicable to pro-
ceedings to review decisions of the Tax Court of the United States
or to proceedings to review or enforce those orders of administra-
tive agencies, boards, commissions, or officers which are by law
reviewable or enforceable by the district courts." [p. 942]
-------
STATUTES AND LEGISLATIVE HISTORY 863
1.8a (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. WILLIS, 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 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 relat-
ing 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.l]
EXPLANATION OF AMENDMENTS
Amendment No. 1.—Several of the Federal agencies and the
American Bar Association propose that the bill be amended to
require the adoption of uniform rules. While uniformity is highly
desirable, there will be special conditions in particular circuits
which will not obtain generally. This amendment seeks substan-
tial uniformity by requiring the approval of the Judicial Confer-
ence to rules promulgated by the various courts of appeals while
at the same time permitting individual courts to make special
provision required by peculiar local conditions.
The latter part of this amendment makes it clear that the rules
to be adopted by the courts of appeals may cover the matters of
time of filing, manner of filing, and contents of the record to the
full extent that such matters or any of them are not specifically
covered by applicable statutes.
Amendment No. 2.—Subsection (a) of new section 2112 has
been expanded in accordance with suggestions made at the hear-
ing on May 17,1956, to provide that the rules of court may author-
ize the agency concerned, to file a certified list of the materials
comprising the record and retain the actual papers in its physical
custody to be transmitted to the court only when and if required
-------
864 LEGAL COMPILATION—PESTICIDES
by the court ill its consideration of the case. This procedure has
been recently tried in several of the courts and found feasible.
In carrying out this provision the instant amendment was inserted
to provide that the filing of a certified list of materials will be
deemed full compliance with any provision of law requiring the
filing of the record.
Amendment No. 3.—This amendment was made in the interest
of precision to implement the provisions of amendment No. 2.
Amendments Nos. 4 and 5.—The bill, as introduced, provided
that if proceedings have been instituted in two or more courts
with respect to the same order, the agency would be required to
file the record in that court which in its judgment would be most
convenient to the parties, and the other courts were then to trans-
fer their proceedings to it. This was intended to provide statutory
authority for the procedure developed by the courts in this situa-
tion. See Columbia Oil and Gas Co. v. Securities and Exchange
Commission (3d Cir. 1943, 134 F. 2d 265) ; L. J. Marquis & Co.
v. Securities & Exch. Com. (2 Cir. 1943,134 F. 2d 335) ; L. J. Mar-
quis & Co. v. Securities & Exchange Com. (3 Cir. 1943, 134 F. 2d
822). This provision would have provided a general rule applicable
to all agency review cases. The use of the phrase "in its judgment"
was intended to make clear that the choice of forum in such a case
was in the discretion of the agency and was not to be reviewable
[P. 4]
except for clear abuse of discretion. However, the American Bar
Association and several of the agencies found fault with the pro-
vision and recommended that the court of appeals—and not a Fed-
eral agency—in which the first proceeding was instituted, should
have exclusive jurisdiction of all proceedings involving the same
order with authority to transfer all the proceedings to another
court of appeals if that would best serve the convenience of the
parties. The committee has adopted this suggestion, and the instant
amendments carry out this recommendation.
Amendment No. 6.—It was suggested that additional portions
of the record ought to be ordered filed when the court thinks it
"proper." It need not be shown to be "necessary" before the
court may do so. Accordingly, this amendment was adopted to
carry out the suggestion.
Amendment No. 7.—Following the introduction of the bill, it
developed that as a result of recent rule changes, no court of
appeals now requires the entire record to be printed. This limi-
tation rendered the provision affected by this amendment
unnecessary.
-------
STATUTES AND LEGISLATIVE HISTORY 865
Amendment No. 8.—The American Bar Association suggested
that the petitioner for review and the respondent in enforcement
proceedings should have the option to require the entire proceed-
ing to be filed in the court. Since subsection (b) of new section
2112 includes a provision giving the agencies the right, at their
option, to file the entire record in the courts, it was deemed proper
that petitioners and respondents, at their option, should also have
the same right, and this amendment so provides.
Amendment No. 9.—This amendment makes a technical change
in the bill.
Amendment No. 10.—This amendment was adopted to make
clear that the bill is not intended to apply to the review of deci-
sions of the Tax Court, which is not an administrative agency,
or to the review of agency orders which are by law reviewable by
the district courts and not, in the first instance, by the several
courts of appeals.
Amendments Nos. 11 and 12.—These amendments remove any
possible ambiguity as to the right of the Federal Trade Commission
to modify or revoke an order under review prior to the filing of
the record. At the same time, the amendments do not interfere
with the basic scheme of the bill to make clear in all cases that
jurisdiction attaches in the court of appeals for the purpose of
making interlocutory and procedural orders from the time of
filing of the petition for review.
Amendments Nos. 13, 14, 15, 16, and 17.—These are clarifying
amendments, and were suggested by the Department of
Agriculture.
Amendment No. 18.—This amendment was adopted at the sug-
gestion of the Securities and Exchange Commission to make
clear that that Commission has concurrent jurisdiction with the
court of appeals to modify, amend*, or revoke its own order
between the time the petition for review is filed and the time the
record is filed. This permits the Commission to carry out the
provisions of the Securities and Exchange Act of 1934, the Public
Utility Holding Company Act of 1935, the Investment Company
Act of 1940 and the Investment Advisers Act of 1940. It was
pointed out at the hearing that, in these cases, there is no advan-
tage to be gained by conferring exclusive jurisdiction on the
court of appeals before the record is filed in that court. In fact,
in some instances, such a procedure might have the effect of
depriving a party of the right of a rehearing before the Commis-
[p.5]
sion and might be construed to deny the Commission the power
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866 LEGAL COMPILATION—PESTICIDES
to stay its own orders after the filing of a petition for review.
Amendments Nos. 19 and 20.—These amendments correct
typographical errors.
Amendment No. 21.—See explanation of amendment No. 18
above.
Amendment No. 22.—This amendment corrects typographical
error.
Amendment No. 23.—This is a clarifying amendment.
Amendments Nos. 24, 25, and 26.—These amendments are
needed to indicate that the definition of "commission" includes
both the Federal Maritime Board and the Department of Com-
merce, as set out in section 905 (e) of the Merchant Marine Act
of 1936, as amended.
Amendment No. 27.—This is a clarifying amendment.
Amendment No. 28.—This is a technical amendment.
Amendments Nos. 29, 30, and 31 are procedural amendments.
Amendments Nos. 32 and 33.—These are clarifying amend-
ments suggested by the Department of Agriculture.
Amendments Nos. 34 and 35.—See explanation of amendment
No. 18 above.
Amendments Nos. 36 and 37.—These amendments give the
courts of appeals jurisdiction upon the filing of the notice of
appeal.
Amendment No. 38.—Section 32 of the bill as introduced is
deleted by this amendment. The Federal Coal Mine Safety Board
of Review pointed out that the procedure upon review of the
orders of that Board is not analogous to other review proceedings
covered by the bill. The Board's proceedings are purely advisory
between parties before the Board and the Board itself is not a par-
ty to the review proceeding. After the committee had decided to
eliminate these provisions from section 32 of the bill, it further
decided, at the suggestion of the Department of Health, Educa-
tion, and Welfare, to add a provision to amplify section 207 (b)
of the act of September 23, 1950, to bring that law in harmony
with the other provisions of the bill affecting the Department of
Health, Education, and Welfare. This provision now forms sec-
tion 32.
Amendments Nos. 39, 40, and 41.—These amendments correct
typographical errors.
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
-------
STATUTES AND LEGISLATIVE HISTORY 867
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 agen-
cies is not relevant to the questions actually raised on appeal. This
legislation, 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.
BACKGROUND
In 1953 the Judicial Conference of the United States referred to
its Committee on Revision of the Laws a proposal that existing
statutes be amended so as to permit administrative agencies whose
orders are to be reviewed by a court of appeals to send to the court
an abbreviated record where the whole record is not necessary.
The proposal also provided for the authorization of the use of the
[p. 6]
original papers in appropriate cases in lieu of a transcript, the
papers to be returned to the administrative agency upon the com-
pletion of the review proceedings. The Judicial Conference com-
mittee concluded that the proposal had substantial merit.
An examination of the Federal statutes authorizing judicial
review of orders of administrative agencies by that committee
disclosed that many of them now specifically require a transcript
of the entire record to be filed by the agency in the court of appeals.
It was thought that these requirements should be eliminated
except in those instances where for some other reason it is neces-
sary to file the entire record.
This objective could, perhaps, have been accomplished by a gen-
eral statute repealing all inconsistent provisions of the various acts
providing for judicial review of agency action. But this would
have left the law in confusion as to what specific provisions would
have been thus repealed by implication. The Judicial Conference
committee became satisfied that in order to deal comprehensively
with the problem it would be necessary to amend many of the
existing statutes.
In addition it seemed advisable to that committee to add a new
section 2112 to title 28 of the United States Code which would
confer rulemaking power in this field upon the courts of appeals
with the approval of the Judicial Conference. Such a statute should,
the committee thought, be modeled upon section 6 of the Hobbs
Act of December 29, 1950 (5 U.S.C. 1036), which provides for uni-
form rules promulgated by the courts of appeals with the approval
of the Judicial Conference.
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868 LEGAL COMPILATION—PESTICIDES
The Committee on Revision of the Laws of the Judicial Confer-
ence accordingly prepared a tentative draft of such an amendatory
statute and submitted it to all the judges of the courts of appeals
and to all the agencies involved for their study and suggestions.
It received a large number of constructive suggestions which it
embodied in the revision of the bill which was introduced in the
84th Congress as H.R. 6682, and which was the subject of a hearing
before Subcommittee No. 3 of the House Committee on the Judici-
ary on May 17, 1956. Thereafter a further document was com-
piled made up of hearings, Government agency reports, and other
comments (hearings, Serial No. 25, House Committee on the Judi-
ciary, 84th Cong.), and was made available to all interested
organizations so that their views could be obtained on the proposed
legislation.
When the legislation (H.R. 6788) was introduced in this Con-
gress, further hearings were held. The Judiciary Committee has
considered the suggestions and feels that the instant bill, as
amended, will make a valuable contribution to the law of appellate
administrative procedures.
The bill has been approved in principle by the American Bar
Association. It incorporates the recommendation of the President's
Conference on Administrative Procedure in this field. It has the
approval of the Judicial Conference of the United States.
STATEMENT AND ANALYSIS OF BILL
The instant bill would add to title 28 of the United States Code a
new section 2112 entitled "Record on review and enforcement of
agency orders." The section includes enforcement as well as review
proceedings in the courts of appeals.
[p. 7]
Subsection (a) of new section 2112 as set out in section 2 of the
bill gives the courts of appeals power to adopt, with the approval of
the Judicial Conference, rules prescribing the time and manner of
filing and the contents of the record in all such proceedings insti-
tuted in those courts to review orders of Federal administrative
agencies, unless present law affecting those agencies specifically
provides a procedure on the subject. The general power granted by
section 2112 (a), however, will render separate statutory provi-
sions unnecessary in the future.
The section also provides that the rules of court may authorize
the Federal administrative agency concerned to file a certified list
of the materials comprising the record and retain the actual papers
in its physical custody to be transmitted to the court only when and
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STATUTES AND LEGISLATIVE HISTORY 869
if required by the court in its consideration of the case. This has
been a procedure which has been recently tried in several of the
appellate courts and has been found quite feasible, saving both
time and money.
As the result of a suggestion by the Securities and Exchange
Commission subsection (a) also includes a provision providing that
if review proceedings have been instituted in two or more courts
with respect to the same order, the Federal administrative agency
involved shall file the record in that court in which a proceeding
was first instituted. The courts in which other proceedings are
pending thereupon will transfer their proceedings to the court of
appeals in which the record has been filed. In the interest of justice
and for the convenience of the parties, such court may thereafter
transfer the proceedings to another court of appeals.
Subsection (b) of proposed section 2112 provides for the abbre-
viation of the record by the inclusion only of such material as the
rules of the court may require, or as the parties, including parties
permitted to intervene by the court, may stipulate, or as the court
may designate by order. The stipulation or order may provide in
an appropriate case, such as a petition for a consent degree enforc-
ing a National Labor Relations Board order, that no record at all
be filed. There are in the courts of appeals many cases in which the
National Labor Relations Board petitions the court to enter an
enforcement decree which has been consented to by the parties
concerned. The Board under present law must spend the time and
public money required to send the court a complete transcript of
the record before the latter can enter the decree requested. Sub-
section (b) will permit dispensing with the filing of the record in
such a case, and a decree may be entered upon the petition and
consenting answer or stipulation.
The provisions of subsection (b) will also enable the parties to
abbreviate the record by eliminating all material not relevant to the
actual questions raised on review, with consequent saving of time
and expense. Provision is made, however, that additional portions
of the record may be ordered by the court if found to be needed.
If the correctness of a finding of fact is in issue, subsection (b)
requires all the evidence to be included in the record except such
part as the parties, by stipulation, agree to omit as wholly imma-
terial to the questioned finding. This provision will enable the
court to perform its duty in cases under section 10 (e) of the
Administrative Procedure Act to "review the whole record or such
portions thereof as may be cited by any party."
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870 LEGAL COMPILATION—PESTICIDES
Several of the Federal agencies advised the committee that in
some instances it would not only delay proceedings but it would be
[p. 8]
more costly to abbreviate the record than it would be to send it in
its entirety to the court of appeals. The subsection therefore con-
tains a provision giving Federal agencies the right, at their option,
to file the entire record instead of an abbreviated record.
The American Bar Association suggested, among other things
that the petitioner for review and the respondent in enforcement
proceedings, should also have the right, at their option, to require
the filing of the entire record. In accordance with this recommenda-
tion, the bill provides for the filing of the entire record of the
proceedings upon such request.
Subsection (c) of new section 2112 as set out in section 2 of the
bill authorizes the transmittal of certified copies instead of the
original papers. A number of agencies pointed out that many of
their records are public records which are required to be kept in
their offices open to public inspection. It was also pointed out that
in many instances an agency must retain the original papers for
use in connection with a related case which is before it but which
is not on review. The subsection therefore contains a provision
authorizing the transmittal of the original papers at the option of
the agency. It also provides that this situation may pertain to a
part, as well as to the whole of, the record so that an agency may
transmit some original papers and certified copies of others. All
original papers and certified copies are to be returned to the agency
at the conclusion of the case.
The bill is not intended to apply to the review of decisions of the
Tax Court, which is not an administrative agency, or to the review
of such agency orders as are by law reviewable by the district
courts, such as exclusion and deportation orders. The Department
of Justice has suggested that this be made explicit in the proposed
legislation. Therefore, subsection (d) has been added to the pro-
posed section 2112 to clarify the congressional intent.
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. It was pointed out at the hear-
ing that this latter provision is illogical and unwise, illogical since
it places it within the power of the Federal agency to delay the
acquisition of full jurisdiction by the court, and unwise since it
raises a serious question as to the extent of the court's power to
-------
STATUTES AND LEGISLATIVE HISTORY 871
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 the record is actually filed. Accordingly, to take care of this
situation, the language of the bill adopts the pattern of the Hobbs
Act (5 U.S.C. 1036) relating to the review of orders of certain
Federal agencies, and proposes to amend the various statutes to
provide in all cases that the reviewing court shall acquire jurisdic-
tion upon the filing of the petition on review.
At the hearings the committee's attention was called to the fact
that the Federal Trade Commission act, the Clayton Act, the Pack-
ers and Stockyards Act, the National Labor Relations Act, the
Federal Power Act and the National Gas Act provide that an
agency acting under and pursuant to them may modify or set aside
its order after a petition for review has been filed and up to the
time of the filing of the record. Giving exclusive jurisdiction to the
courts upon the filing of the petition, as the instant bill, as intro-
[p. 9]
duced, provides, could work undue hardship. The bill was therefore
amended to provide that although jurisdiction shall be immediately
acquired by the court upon the filing of a petition for review, such
jurisdiction will be concurrent and shall become exclusive only
upon the filing of the record.
Sections 3 to 33 contain provisions which make changes to
present 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:
*******
[p. 10]
the words "under the provisions of this act," should be inserted
after the words "in part". The word "find" on page 17, line 5,
should be amended to read "finding."
However, legislation on this subject may not be necessary at
this time because the entire matter can be handled adequately by
court rules. For example, a number of the courts (Court of Appeals
2d, 3d, 4th, 5th, 10th, and the District of Columbia Circuit) have
promulgated rules to facilitate the filing of agency records for
review. There could readily be opportunity for further experi-
mentation, which is possible under the statutes as they now stand,
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872 LEGAL COMPILATION—PESTICIDES
but in any event the present degree of flexibility in such matters
should be preserved.
FEDERAL POWER COMMISSION,
By JEROME K. KUYKENDALL, Chairman
TITLE 28. UNITED STATES CODE
CHAPTER 133. REVIEW—MISCELLANEOUS PROVISIONS
*******
2112. Record on review and enforcement of agency orders.
*******
§ 2112. Record on review and enforcement of agency orders.
(a) The several courts of appeals shall have power to adopt, with
the approval of the Judicial Conference of the United States, rules,
which so far as practicable shall be uniform in all such courts
prescribing the time and manner of filing and the contents of the
record in all proceedings instituted in the courts of appeals to
enjoin, set aside, suspend, modify, or otherwise review or enforce
orders of administrative agencies, boards, commissions, and
officers, to the extent that the applicable statute does not specifical-
ly prescribe such time or manner of filing or contents of the
record. Such rules may authorize the agency, board, commission, or
officer to file in the court a certified list of the materials comprising
the record and retain and hold for the court all such materials and
transmit the same or any part thereof to the court, when and as
required by it, at any time prior to the final determination of the
proceeding, and such filing of such certified list of the materials
comprising the record and such subsequent transmittal of any
such materials when and as required shall be deemed full compli-
ance with any provision of law requiring the filing of the record in
the court. The record in such proceedings shall be certified and
filed in or held for and transmitted to the court of appeals by the
agency, board, commission, or officer concerned within the time
and in the manner prescribed by such rules. If proceedings have
been instituted in two or more courts of appeals with respect to
the same order the agency, board, commission or officer concerned
shall file the record in that one of such courts in which a proceeding
with respect to such order was first instituted. The other courts
[p. 35]
in which such proceedings are pending shall thereupon transfer
them to the court of appeals in which the record has been filed. For
the convenience of the parties in the interest of justice such court
may thereafter transfer all the proceedings with respect to such
order to any other court of appeals.
-------
STATUTES AND LEGISLATIVE HISTORY 873
(b) The record to be filed in the court of appeals in such a
proceeding shall consist of the order sought to be reviewed or
enforced, the findings or report upon which it is based, and the
pleadings, evidence, and proceedings before the agency, board,
commission, or officer concerned, or such portions thereof (1) as
the said rules of the court of appeals may require to be included
therein, or (2) as the agency, board, commission, or officer con-
cerned, the petitioner for review or respondent in enforcement, as
the case may be, and any intervenor in the court proceeding by
written stipulation filed with the agency, board, commission, or
officer concerned or in the court in any such proceeding may con-
sistently with the rules of such court designate to be included
therein, or (3) as the court upon motion of a party or, after a
prehearing conference, upon its own motion may by order in any
such proceeding designate to be included therein. Such a stipulation
or order may provide in an appropriate case that no record need
be filed in the court of appeals. If, however, the correctness of a
finding of fact by the agency, board, commission, or officer is in
question all of the evidence before the agency, board, commission,
or officer shall be included in the record except such as the agency,
board, commission, or officer concerned, the petitioner for review
or respondent in enforcement, as the case may be, and any inter-
venor in the court proceeding by written stipulation filed with the
agency, board, commission, or officer concerned or in the court
agree to omit as wholly immaterial to the questioned finding. If
there is omitted from the record any portion of the proceedings
before the agency, board, commission, or officer which the court
subsequently determines to be proper for it to consider to enable it
to review or enforce the order in question the court may direct that
such additional portion of the proceedings be filed as a supplement
to the record. The agency, board, commission, or officer concerned
may, at its option and without regard to the foregoing provisions
of this subsection, and if so requested by the petitioner for review
or respondent in enforcement shall, file in the court the entire
record of the proceedings before it without abbreviation.
(c) The agency, board, commission, or officer concerned may
transmit to the court of appeals the original papers comprising the
whole or any part of the record or any supplemental record, other-
wise true copies of such papers certified by an authorized officer
or deputy of the agency, board, commission, or officer concerned
shall be transmitted. Any original papers thus transmitted to the
court of appeals shall be returned to the agency, board, commission,
or officer concerned upon the final determination of the review or
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874 LEGAL COMPILATION—PESTICIDES
enforcement proceeding. Pending such final determination any
such papers may be returned by the court temporarily to the
custody of the agency, board, commission, or officer concerned if
needed for the transaction of the public business. Certified copies
of any papers included in the record or any supplemental record
may also be returned to the agency, board, commission, or officer
concerned upon the final determination of review or enforce-
ment proceedings.
(d) The provisions of this section are not applicable to proceed-
ings to review decisions of the Tax Court of the United States or to
proceedings to review or enforce those orders of administrative
agencies, boards, commissions, or officers which are by law review-
able or enforceable by the district court.
[p. 36]
1.8a (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
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
-------
STATUTES AND LEGISLATIVE HISTORY 875
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.I]
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 sub-
mission, 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
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
-------
876 LEGAL COMPILATION—PESTICIDES
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.
The bill is not intended to apply to the review of decisions of the
Tax Court, which is not an administrative agency within the
contemplation of this measure, or to the review of such agency
orders as are by law reviewable by the district courts, such as
exclusion and deportation 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
of full jurisdiction by a Federal appellate court; and unwise, since
it raises a serious question concerning the extent of the court's
[p. 2]
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
provide that in all cases the reviewing court shall acquire jurisdic-
tion upon the filing of a petition for 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.
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 follow-
ing ways:
-------
STATUTES AND LEGISLATIVE HISTORY 877
(1) By giving the courts of appeals, with the approval of
the Judicial Conference, authority to adopt rules on the sub-
ject, 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;
[p. 3]
(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
(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
petition 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
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878 LEGAL COMPILATION—PESTICIDES
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
agencies within the Federal Government, the Congress has seen
fit to authorize judicial review of the orders of such agencies and
bureaus 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 individual 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.
The bill was the subject of thorough consideration in the Judicial
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 laudable effort to
[p-4]
-------
STATUTES AND LEGISLATIVE HISTORY 879
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
Administrative 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.
VIEWS OP EXECUTIVE DEPARTMENTS
[p. 5]
*******
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 italic,
existing law in which no change is proposed is shown in roman) :
TITLE 28. UNITED STATES CODE
CHAPTER 133. REVIEW—MISCELLANEOUS PROVISIONS
*******
2112. Record on review and enforcement of agency orders.
*******
% 2112. Record on review and enforcement of agency orders.
(a) The several courts of appeals shall have power to adopt, with
the approval of the Judicial Conference of the United States, rules,
which so far as practicable shall be uniform in all such courts pre-
scribing the time and manner of filing and the contents of the
record in all proceedings instituted in the courts of appeals to.
enjoin, set aside, suspend, modify, or otherwise review or enforce
orders of administrative agencies, boards, commissions, and officers,
to the extent that the applicable statute does not specifically
prescribe such time or manner of filing or contents of the record.
Such rules may authorize the agency, board, commission, or
officer to file in the court a certified list of the materials comprising
-------
880 LEGAL COMPILATION—PESTICIDES
the record and retain and hold for the court all such materials and
transmit the same or any part thereof to the court, when and as
required by it, at any time prior to the final determination of the
proceeding, and such filing of such certified list of the materials
comprising the record and such subsequent transmittal of any
such materials when and as required shall be deemed full compli-
ance with any provision of law requiring the filing of the record
in the court. The record in such proceedings shall be certified and
filed in or held for and transmitted to the court of appeals by the
agency, board, commission, or officer concerned ivithin the time
and in the manner prescribed by such rules. If proceedings have
been instituted in two or more courts of appeals with respect to
the same order the agency, board, commission or officer concerned
shall file the record in that one of such courts in which a proceeding
with respect to such order was first instituted. The other courts in
which such proceedings are pending shall thereupon transfer them
to the court of appeals in which the record has been filed. For the
convenience of the parties in the interest of justice such court may
thereafter transfer all the proceedings with respect to such order
to any other court of appeals. [p. 8]
(b) The record to be filed in the court of appeals in such a pro-
ceeding shall consist of the order sought to be reviewed or enforced,
the findings or report upon which it is based, and the pleadings,
evidence, and proceedings before the agency, board, commission, or
officer concerned, or such portions thereof (1) as the said rules of
the court of appeals may require to be included therein, or (2) as
the agency, board, commission, or officer concerned, the petitioner
for review or respondent in enforcement, as the case may be, and
any intervenor in the court proceeding by written stipulation filed
with the agency, board, commission, or officer concerned or in the
court in any such proceeding may consistently with the rules of
such court designate to be included, therein or (3) as the court
upon motion of a party or, after a prehearing conference, upon its
own motion may by order in any such proceeding designate to be
included therein. Such a stipulation or order may provide in an
appropriate case that no record need be filed in the court of appeals.
If, however, the correctness of a finding of fact by the agency,
board, commission, or officer is in question all of the evidence be-
fore the agency, board, commission, or officer shall be included in
the record except such as the agency, board, commission, or officer
concerned, the petitioner for review or respondent in enforcement,
as the case may be, and any intervenor in the court proceeding by
written stipulation filed with the agency, board, commission, or
-------
STATUTES AND LEGISLATIVE HISTORY 881
officer concerned or in the court agree to omit as wholly immaterial
to the questioned finding. If there is omitted from the record any
portion of the proceedings before the agency, board, commission, or
officer which the court subsequently determines to be proper for it
to consider to enable it to review or enforce the order in question
the court may direct that such additional portion of the proceedings
be filed as a supplemental to the record. The agency, board, com-
mission, or officer concerned may, at its option and without regard
to the foregoing provisions of this subsection, and if so requested
by the petitioner for review or respondent in enforcement shall file
in the court the entire record of the proceedings before it without
abbreviation.
(c) The agency, board, commission, or officer concerned may
transmit to the court of appeals the original papers comprising
the whole or any part of the record or any supplemental record,
otherwise true copies of such papers certified by an authorized
officer or deputy of the agency, board, commission, or officer con-
cerned shall be transmitted. Any original papers thus transmitted
to the court of appeals shall be returned to the agency, board,
commission, or officer concerned upon the final determination of
the review or enforcement proceeding. Pending such final deter-
mination any such papers may be returned by the court tempo-
rarily to the custody of the agency, board, commission, or officer
concerned if needed for the transaction of the public business.
Certified copies of any papers included in the record or any supple-
mental record may also be returned to the agency, board, commis-
sion, or officer concerned upon the final determination of review
or enforcement proceedings.
(d) The provisions of this section are not applicable to proceed-
ings to review decisions of the Tax Court of the United States or
to proceedings to review or enforce those orders of administrative
agencies, boards, commissions, or officers which are by law review-
able or enforceable by the district court. [p. 9]
1.8a (3) CONGRESSIONAL RECORD
1.8a (3) (a) VOL. 103 (1957), Aug. 5: Amended and passed House,
pp. 13617-13618
[No Relevant Discussion on Pertinent Section]
1.8a(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-
ministration agencies, was announced
as next in order.
Mr. HRUSKA. Mr. President, may
we have an explanation of the bill?
Mr. EASTLAND. Mr. President,
-------
882
LEGAL COMPILATION—PESTICIDES
this bill authorizes the several courts
of appeals of the United States to
adopt rules authorizing the abbrevia-
tion of the transcript and other parts
of the record made before Federal ad-
ministrative 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 un-
der review. Many times, likewise, the
record 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 peti-
tions 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 agen-
cy, 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 reading,
read the third time, and passed.
[p.17537]
1.9 COURTS OF APPEALS; CERTIORARI; APPEALS; CERTI-
FIED QUESTIONS. 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),15U.S.C.§1474(b) (5)]
COURTS OF APPEALS; CERTIORARI; APPEAL;
CERTIFIED QUESTIONS
28 § 1254
Cases in the courts of appeals may be reviewed by the Supreme
Court by the following methods:
(1) By writ of certiorari granted upon the petition of any party
to any civil or criminal case, before or after rendition of judgment
or decree;
-------
STATUTES AND LEGISLATIVE HISTORY 883
(2) By appeal by a party relying on a State statute held by a
court of appeals to be invalid as repugnant to the Constitution,
treaties or laws of the United States, but such appeal shall pre-
clude review by writ of certiorari at the instance of such appel-
lant, and the review on appeal shall be restricted to the Federal
questions presented;
(3) By certification at any time by a court of appeals of any
question of law in any civil or criminal case as to which instruc-
tions are desired, and upon such certification the Supreme Court
may give binding instructions or require the entire record to be
sent up for decision of the entire matter in controversy. June 25,
1948, c. 646, 62 Stat. 928.
1.9a APPEALS TO AND/OR FROM THE CIRCUIT COURT OF
APPEALS
March 3, 1911, P.L. 61-475, §§239, 240, 36 Stat. 1157
SEC. 239. In any case within its appellate jurisdiction, as defined
in section one hundred and twenty-eight, the circuit court of
appeals at any time may certify to the Supreme Court of the United
States any questions or propositions of law concerning which it
desires the instruction of that court for its proper decision; and
thereupon the Supreme Court may either give its instruction on
the questions and propositions certified to it, which shall be binding
upon the circuit court of appeals in such case, or it may require
that the whole record and cause be sent up to it for its considera-
tion, and thereupon shall decide the whole matter in controversy in
the same manner as if it had been brought there for review by
writ of error or appeal.
SEC. 240. In any case, civil or criminal, in which the judgment or
decree of the circuit court of appeals is made final by the provisions
of this Title, it shall be competent for the Supreme Court to require,
by certiorari or otherwise, upon the petition of any party thereto,
any such case to be certified to the Supreme Court for its review
and determination, with the same power and authority in the case
as if it had been carried by appeal or writ of error to the Supreme
Court.
[p. 1157]
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884 LEGAL COMPILATION—PESTICIDES
1.9a (1) SENATE SPECIAL JOINT COMMITTEE ON REVI-
SION AND CODIFICATION OF LAWS
S. REP. No. 388 (parts 1 & 2), 61st Cong., 2d Sess. (1910)
S.7031
REVISION OF LAWS—JUDICIARY TITLE
MARCH 14,1910.—Ordered to be printed
Mr. HEYBURN, from the Special Joint Committee on Revision and
Codification of the Laws of the United States, submitted the
following
REPORT—PART 1
[To accompany S. 7031]
The Joint Committee on Revision and Codification of the Laws
of the United States submit herewith an explanatory statement of
each section contained in Senate Bill 7031.
This bill includes the first 12 chapters of the judiciary title, be-
ing title 13 of the Revised Statutes of 1878, with all legislation
amending, repealing, or modifying the same. Chapter 13, on habeas
corpus, chapter 15, on juries, and chapters 20 and 21, on the Court
of Claims, are included within this bill. [p. 1]
Section 239:
This section states concisely the appellate j urisdiction of the Su-
preme Court conferred upon it by the bankruptcy act of July 1,
1898 (2 Supp., 853). The only changes in phraseology are those
necessary to separate the provisions relating to the Supreme Court
from those relating to other courts.
Section 240:
Existing law; no change whatever. [p. 85]
1.9a (2) HOUSE COMMITTEE ON REVISION OF THE LAWS
H.R. Doc. No. 783, (part 1), 61st Cong., 2d Sess. (1910)
REVISION AND CODIFICATION OF THE LAWS, ETC.
MARCH 15,1910.—Referred to the Committee on Revision of the Laws and
ordered to be printed
Mr. MOON, of Pennsylvania, from the Special Joint Committee on
the Revision of the Laws, submitted the following report:
-------
STATUTES AND LEGISLATIVE HISTORY 885
The House members of the Special Joint Committee on the Re-
vision of the Laws, appointed under public resolution No. 58 of
the Sixtieth Congress, second session, to examine, consider, and
submit to Congress recommendations upon the revision and codifi-
cation of the laws prepared by the statutory Revision Commission,
heretofore authorized to revise and codify the laws of the United
States, having had under consideration the judiciary title reported
by that commission, and deeming it both necessary and expedient
to make certain changes, additions, and omissions, report in lieu
thereof the accompanying bill and submit the following report
thereon:
*******
[p.l]
Section 239:
This section states concisely the appellate jurisdiction of the Su-
preme Court conferred upon it by the bankruptcy act of July 1,
1898 (2 Supp., 853). The only changes in phraseology are those
necessary to separate the provisions relating to the Supreme Court
from those relating to other courts.
Section 240:
Existing law; no change whatever.
[p. 89]
1.9a (3) HOUSE COMMITTEE ON REVISION OF THE LAWS
H.R. REP. No. 818, 61st Cong., 2d Sess. (1910)
REVISION OF LAWS
MARCH 23,1910.—Referred to the House Calendar and ordered to be printed
Mr. MOON, of Pennsylvania, from the Committee on Revision of
the Laws, submitted the following
REPORT
[To accompany H.R. 23377]
The Committee on the Revision of the Laws, to whom was re-
ferred the bill H.R. 23377, submit the following report:
This bill having previously been considered by the Joint Com-
mittee on the Revision of the Laws, to which it was committed
under public resolution No. 58, Sixtieth Congress, second session,
which committee made a complete report thereon (H. Doc. No. 783,
-------
886 LEGAL COMPILATION—PESTICIDES
parts 1 and 2), this committee, upon the basis of that report, re-
ports the same back to the House with favorable recommendation.
[p-1]
1.9a (4) COMMITTEE OF CONFERENCE
S. DOC. No. 848, 61st Cong., 3rd Sess. (1911)
REVISION AND CODIFICATION OF THE LAWS.
MR. HEYBURN presented the following
CONFERENCE REPORT RELATIVE TO THE REVISION AND CODIFICATION
OF THE LAWS
MARCH 1,1911.—Ordered to be printed
The committee of conference on the disagreeing votes of the two
Houses on the amendment of the House to the bill S. 7031, being a
bill to codify, revise, and amend the laws relating to the judiciary,
having met, after full and free conference, have agreed to recom-
mend, and do recommend, to their respective Houses as follows:
That the Senate agree to the House amendment, with amend-
ments to sections 2, 13, 14, 21, 24, 28, 29, 30, 40, 56, 70, 76, 78, 88,
91, 92, 99, 103, 106, 112, 118, 126, 128, 140, 151, 152, 178, 182, 186,
201, 207, 226 227, 228, 229, 240, 250, 251, 259, 284, 289, 298, 301.
That the House agree to the amendments proposed by the Senate
conferees, as follows:
(The references to section numbers and pages are to the bill as
reported by the conferees and not to the bill as it passed the House
or Senate.)
[p.l]
Section 240. On page 192, in line 19, after the word "case" insert
civil or criminal; in line 22, after the word "otherwise," insert
upon the petition of any party thereto.
[p. 6]
-------
STATUTES AND LEGISLATIVE HISTORY 887
1.9a (5) CONGRESSIONAL RECORD, VOL. 46 (1911)
1.9a (5) (a) Feb. 8: Amended and passed Senate, p. 2140
[No Relevant Discussion on Pertinent Section]
1.9a (5) (b) Feb. 23: Amended and passed House, p. 3220
[No Relevant Discussion on Pertinent Section*]
1.9a (5) (c) March 2: Senate agreed to conference report, p. 3853
[No Relevant Discussion on Pertinent Section*]
1.9a (5) (d) March 2: House agreed to conference report, pp. 3998,
4000, 4012
[No Relevant Discussion on Pertinent Section*]
1.9b JUDICIAL CODE AMENDMENTS OF 1925
February 13, 1925, P.L. 68-415, §1, 43 Stat. 938
SEC. 1.
*******
"SEC. 239. In any case, civil or criminal, in a circuit court of
appeals, or in the Court of Appeals of the District of Columbia,
the court at any time may certify to the Supreme Court of the
United States any questions or propositions of law concerning
which instructions are desired for the proper decision of the cause;
and thereupon the Supreme Court may either give binding instruc-
tions on the questions and propositions certified or may require
that the entire record in the cause be sent up for its consideration,
and thereupon shall decide the whole matter in controversy in the
same manner as if it had been brought there by a writ of error
or appeal."
SEC. 240. (a) In any case, civil or criminal, in a circuit court of
appeals, or in the Court of Appeals of the District of Columbia, it
shall be competent for the Supreme Court of the United States,
upon the petition of any party thereto, whether Government or
other litigant, to require by certiorari, either before or after a
[p. 938]
judgment or decree by such lower court, that the cause be certified
to the Supreme Court for determination by it with the same power
and authority, and with like effect, as if the cause had been brought
there by unrestricted writ of error or appeal.
"(b) Any case in a circuit court of appeals where is drawn in
question the validity of a statute of any State, on the ground of its
being repugnant to the Constitution, treaties, or laws of the United
States, and the decision is against its validity, may, at the election
of the party relying on such State statute, be taken to the Supreme
-------
888 LEGAL COMPILATION—PESTICIDES
Court for review on writ of error or appeal; but in that event a
review on certiorari shall not be allowed at the instance of such
party, and the review on such writ of error or appeal shall be
restricted to an examination and decision of the Federal questions
presented in the case.
"(c) No judgment or decree of a circuit court of appeals or of
the Court of Appeals of the District of Columbia shall be subject
to review by the Supreme Court otherwise than as provided in
this section."
[p. 939]
1.9b (1) HOUSE COMMITTEE ON THE JUDICIARY
H.R. REP. No. 1075, 68th Cong., 2d Sess. (1925)
JURISDICTION OF CIRCUIT COURTS OF APPEALS AND
OF THE SUPREME COURT
JANUARY 6,1925.—Referred to the House Calendar and ordered to be printed
Mr. GRAHAM, from the Committee on the Judiciary, submitted the
following
REPORT
[To accompany H.R. 8206]
The Committee on the Judiciary, to whom was referred the bill
H.R. 8206, after hearings and consideration, report favorably
thereon with amendments, and recommend that the bill as amended
do pass.
The committee amendments are as follows:
On page 2, line 11, strike out "Constituton" and insert "Consti-
tution."
On page 5, in line 5, strike out "taken" and insert "applied for."
On page 8, after line 5, insert the following paragraph:
(5) Section 316 of "An act to regulate interstate and foreign commerce in
livestock, livestock products, dairy products, poultry, poultry products, and
eggs, and for other purposes," approved August 15,1921.
On page 10, in line 11, strike out "writ of error or."
On page 11, in line 9, add the following sentence:
A circuit judge shall have the same power to grant writs of habeas corpus
within his circuit that a district judge has within his district; and the order
of the circuit judge shall be entered in the records of the district court of the
district wherein the restraint complained of is had.
On page 13, in line 5, insert between "Supreme Court" and "be-
fore the court" the words "from a circuit court of appeals or the
-------
STATUTES AND LEGISLATIVE HISTORY 889
Court of Appeals of the District of Columbia."
On page 13, between lines 8 and 9, insert two paragraphs as
follows:
(c) No writ of error or appeal intended to bring any judgment or decree
before a circuit court of appeals for review shall be allowed unless applica-
tion therefor be duly made within three months after the entry of such
judgment or decree.
(d) In any case in which the final judgment or decree of any court is sub-
ject to review by the Supreme Court on writ of certiorari, the execution and
enforcement of such judgment or decree may be stayed for a reasonable time
to enable the party aggrieved to apply for and to obtain a writ of certiorari
from the Supreme Court. The stay may be granted by a judge of the court
rendering the judgment or decree or by a justice of the Supreme Court, and
may be conditioned on the giving of good and sufficient security, to be
[P.I]
approved by such judge or justice, that if the aggrieved party fails to make
application for such writ within the period allotted therefor, or fails to
obtain an order granting his application, or fails to make his plea good in
the Supreme Court, he shall answer for all damages and costs which the other
party may sustain by reason of the stay.
On page 17, above line 1, insert the following:
An act entitled "An act to amend the Judicial Code, in reference to appeals
February 17,1922.
An act entitled "An act to amend the Judicial Code, in reference to appeals
and writs of error," approved September 14, 1922.
On page 15, line 20, strike out "1916" and insert in lieu thereof
"1917."
THE BILL
It is one prepared by justices of the Supreme Court, not as volun-
teers, but in answer to a proper request to do so. A committee of
justices carefully considered the subject for a long time and then
framed a tentative measure, which was submitted to all the
justices and approved by them.
THE OBJECT
The bill is designed to lessen the number of cases which under
existing law reach the Supreme Court. It will not lighten the bur-
den or relieve the Supreme Court of work, but will remove from
their consideration a class of cases which now burden the docket
and have no public interest or value, and give the Supreme Court
time to hear and determine those cases which should alone engage
their attention. That court is more than a year behind on its list
of pending cases, and this condition will surely be aggravated each
year if the court is left without relief. It is hoped by this bill to
enable the court to overtake its work, and keep up with it. Having
to hear numbers of cases of a trivial character, or cases brought
-------
890 LEGAL COMPILATION—PESTICIDES
really for delay, or to wear out an adversary, the court is hindered
from hearing and determining more important cases and from
efficiently functioning in the performance of its highest duty of
interpreting the Constitution and preserving uniformity of deci-
sion by the intermediate courts of appeals.
The Supreme Court will always have plenty to do whether this
bill passes or not. The problem is whether the time and attention
and energy of the court shall be devoted to matters of large public
concern, or whether they shall be consumed by matters of less con-
cern, without especial general interest, and only because the liti-
gant wants to have the court of last resort pass upon his right.
Although final decisions will be multiplied in the intermediate
courts of appeals by this bill, if it shall become a law, yet every
case now reviewable by the Supreme Court under existing law will
still be reviewable by that tribunal whenever a question is pre-
sented which is of sufficient importance in the opinion of the Su-
preme Court. The obligatory appeal and writ of error is limited,
and a very broad and comprehensive discretionary power is given
by certiorari. Through this discretionary power there can and will
be a weeding out of all trivial and unimportant cases: cases
brought for delay; cases which cover matters already decided,
etc., so that rapidity of action will be achieved; and the public
questions—the vital and important ones—will be reviewed, con-
sidered, and decided. [p. 2]
The change of many cases from the obligatory class to the cer-
tiorari class will enable the court by a denial of the writ to give
immediate notice to the parties of the disposition of their cases. It
will greatly reduce the number of those who have to wait until
their cases are reached on the docket and relieve them of the
needless suspense and delay to which they are now subjected. The
opportunity of taking cases to the Supreme Court merely for delay
will be almost entirely removed.
Lest it should be thought that the increase of discretionary juris-
diction might impair the administration of justice and lead to par-
tial hearings and not secure a decision by the whole court, it is
proper to call attention to the very thorough and complete system
by which discretionary jurisdiction is exercised. In granting or
refusing a prayer for a certiorari the petitioner gets the judgment
of the whole court. The application is not disposed of by a single
justice. The luminous and informing statement of Mr. Justice
Van Devanter tells the whole story:
"While the authority of the Supreme Court to take cases on petition for cer-
tiorari is spoken of as a discretionary jurisdiction, this does not mean that the
-------
STATUTES AND LEGISLATIVE HISTORY 891
court is authorized merely to exercise a will in the matter but rather that the
petition is to be granted or denied according to a sound judicial discretion.
What actually is done may well be stated here with some particularity. The
party aggrieved by the decision of the circuit court of appeals and seeking a
further review in the Supreme Court is required to present to it a petition and
accompanying brief, setting forth the nature of the case, what questions are
involved, how they were decided in the circuit court of appeals, and why the
case should not rest on the decision of that court. The petition and brief are
required to be served on the other party, and time is given for the presenta-
tion of an opposing brief. When this has been done copies of the printed record
as it came from the circuit court of appeals and of the petition and briefs are
distributed among the members of the Supreme Court, and each judge exam-
ines them and prepares a memorandum or note indicating his view of what
should be done.
In conference these cases are called, each in its turn, and each judge states
his views in extenso or briefly as he thinks proper; and when all have spoken
any difference in opinion is discussed and then a vote is taken. I explain this
at some length because it seems to be thought outside that the cases are
referred to particular judges, as, for instance, that those coming from a par-
ticular circuit are referred to the justice assigned to that circuit, and that
he reports on them, and the others accept his report. That impression is
wholly at variance with what actually occurs.
We do not grant or deny these petitions merely according to a majority
vote. We always grant the petition when as many as four think that it should
be granted and sometimes when as many as three think that way. We pro-
ceed upon the theory that, if that number out of the nine are impressed with
the thought that the case is one that ought to be heard and decided by us, the
petition should be granted."
PROPOSED CHANGES IN SUPREME COURT'S METHOD OP REVIEW
The great object of this bill is to reduce the number of cases in
which there is an appeal or writ of error as of right, and increase
those in which only a certiorari or a certificate can bring the case
before the Supreme Court.
The courts over which the Supreme Court in this bill exercise
a direct review are:
First. The State supreme courts.
Second. The district courts of the United States.
Third. The circuit courts of appeal.
Fourth. Court of Appeals of the District of Columbia.
Fifth. Court of Claims.
[p. 3]
Sixth. Supreme Court of the Philippines.
The only cases in the proposed bill in which the Supreme Court
exercises obligatory jurisdiction—that is, by writ of error or
appeal—are:
First. Over the final judgments or decrees of State courts of
last resort.
-------
892 LEGAL COMPILATION—PESTICIDES
(a) In cases in which the validity of the statute of a State under
the Federal Constitution has been drawn in question and its valid-
ity sustained.
(b) Where the validity of a Federal statute or treaty has been
drawn in question and its validity denied.
Second. In four special classes of cases from the district court,
which are:
(a) Appeals from decrees in equity in suits brought by the
United States to enforce the antitrust or interstate commerce acts.
(b) Writs of error in criminal cases brought by the United States
to judgments of the district courts in which the United States has
been defeated by a ruling of the district court, and where the
defendant has not been exposed to jeopardy or acquitted by a
verdict of the jury.
(c) Appeals from interlocutory injunctions against enforce-
ment of State statutes by any officer of the State, or against the
exercise of an authority of a board acting under a State statute.
(d) Appeals from interlocutory and final decrees of injunction
and suspension of orders of Interstate Commerce Commission in
district courts.
In all other cases, to wit, (a) final judgments in the State su-
preme courts which involve Federal constitutional questions other
than those above mentioned; (b) all cases in the circuit courts of
appeals; (c) all cases in the Court of Appeals of the District of
Columbia; (d) all cases in the Court of Claims; and (e) certain
classes of cases from the Supreme Court of the Philippines, the
only method of review is either by certiorari from the Supreme
Court, or (except from the Philippines) by certificate by the in-
ferior court of questions. Writs of certiorari to State supreme
courts, to the Court of Claims, and to the Supreme Court of the
Philippines, can only issue after final judgments in those courts.
Such writs may issue to circuit courts of appeals and to the Court
of Appeals of the District of Columbia, before or after judgment,
but if before judgment, the application must be made before the
hearing and submission in those courts.
It is impossible to estimate how many cases these changes will
transfer from the obligatory jurisdiction of the Supreme Court,
as it is under existing law, to the discretionary jurisdiction of
the Supreme Court, but it will be such a substantial number as
greatly to help the court to catch up with its docket and to keep up
with it thereafter.
-------
STATUTES AND LEGISLATIVE HISTORY 893
JURISDICTION OF THE CIRCUIT COURTS OF APPEALS
We come now to the present and the proposed jurisdiction of the
circuit courts of appeal, from which we can get some idea of the
change in the appellate jurisdiction of the Supreme Court of cases
from the circuit court of appeals. Under the present law, the circuit
court of appeals has appellate jurisdiction in respect to all cases
[P. 4]
from the district court, except the four instances of direct appeal
to the Supreme Court already mentioned, as still retained in the
proposed bill, and also except in cases in which appeal can now be
taken from the district court directly to the Supreme Court, on the
sole question of jurisdiction of the district court as a Federal court,
on a question involving the construction and application of the
Constitution of the United States, or the construction of a treaty
and in prize cases, and in suits therein against the United States
for claims not exceeding $10,000 under what is known as the
Tucker Act, a jurisdiction of the district courts concurrent with
that of the Court of Claims. The new bill abolishes this direct
review of the Supreme Court in all these except the four instances
first mentioned and makes them subject to review by writ of error
or appeal in the circuit court of appeals, and thence they are only
reviewable by certiorari or certificate in the Supreme Court.
EXISTING LAW AS TO REVIEW OF CASES IN CIRCUIT COURTS OF APPEALS
Circuit courts of appeal now have final appellate jurisdiction in
all cases from the district courts wherein the amount involved does
not exceed $1,000, in diverse citizenship cases, in patent cases, in
copyright cases, in revenue cases, in criminal cases, in admiralty
cases, in trade-mark cases, and in bankruptcy proceedings, contro-
versies, and cases, in cases under the employers' liability act, in
cases under the hour of service act and cases under the safety
appliance act, and also in habeas corpus cases. These can under
existing law only reach the Supreme Court by certiorari or certifi-
cate. In all other cases coming up to the circuit court of appeals
from the district courts, there is, by existing law, an appeal or writ
of error as of right to the Supreme Court.
WRITS OF ERROR AND APPEALS FROM CIRCUIT COURTS OF APPEALS TO
THE SUPREME COURT CUT OFF BY THE BILL
Just what cases may, by existing law, be taken to the Supreme
Court from the circuit court of appeals by writ of error or appeal it
is difficult to state in a brief way. Section 24 of the Judicial Code
contains a list of 25 classes of civil suits that are cognizable by dis-
trict courts of the United States and are reviewable by the circuit
-------
894 LEGAL COMPILATION—PESTICIDES
court of appeals. They embrace suits so rarely brought as to be
regarded as nearly obsolete, e. g., "suits arising under any law
relating to the slave trade." On the other hand, they do include
such classes as civil suits.
(1) Brought by the United States, pr by any officer thereof
authorized by law to sue.
(2) Between citizens of the same State claiming lands under
grants from different States.
(3) Where more than $3,000 is involved and the suit arises
under the Constitution or laws or treaties of the United States.
(4) Seizures on land or waters not within admiralty or maritime
jurisdiction.
(5) Cases arising under the postal laws.
(6) Suits and proceedings under any law regulating commerce,
except such as may be covered by special statutes already men-
tioned.
(7) Civil suits and proceedings for enforcement of penalties
and forfeitures incurred under any law of the United States.
[p. 5]
(8) Suits for damages by officers and persons for injury done
him in protection or collection of United States revenue or to
enforce right of citizens to vote.
(9) Suits for damages by citizens injured in their Federal
constitutional rights.
(10) S uits against consuls and vice consuls.
(11) Suits under immigration and contract labor laws.
(12) Private suits under the antitrust act.
(13) Suits by Indians or part blood Indians for allotment un-
der any law or treaty.
(14) Suits by tenants in common or joint tenant for partition of
land in which the United States is also tenant in common or joint
tenant.
All these cases can now be heard in review by the circuit court of
appeals and then in the Supreme Court as of right, unless, as may
happen, they are also patent, revenue, criminal, or admiralty cases,
or in some other class now made final in the circuit court of appeals.
Under the proposed bill, the decisions in them in the circuit court
of appeals are to be final and they can only reach the Supreme
Court by certiorari or certificate.
REVIEW OP COURTS OP ALASKA AND DEPENDENCIES
Under existing law, appellate jurisdiction over the courts of our
dependencies (except those of the Philippines), and over the dis-
trict court of the Territory of Alaska, and over the United States
-------
STATUTES AND LEGISLATIVE HISTORY 895
court for China, is distributed between first, third, fifth, and ninth
circuit court of appeals. Cases from the Supreme Courts of Hawaii
and Porto Rico, as distinguished from United States district courts,
so called therein, are now reviewable in the Supreme Court of the
United States, when they present questions similar to those which
are reviewable in that court from State courts of last resort; and
some cases from the district court of Alaska also go to the Supreme
Court direct. All these cases from the dependencies, from Alaska,
and from the United States Court for China, under the new bill,
which are reviewable at all, no matter what they involve, are to be
carried by appeal or writ of error to the designated circuit court of
appeals. This final jurisdiction of circuit courts of appeals under
the new bill includes Porto Rico, Hawaii, both supreme and district
courts, the District Court of the Virgin Islands, the Court of the
Canal Zone, the United States Court for China, and the United
States District Court for Alaska. The review of these is final in the
designated circuit court of appeals, except that there is the same
opportunity for review by certiorari and certificate in the Supreme
Court as in other cases in such circuit courts of appeals. A few
changes have been made in the limit of the pecuniary amount
involved in cases which may be appealed from these dependency
and territorial courts, for the purpose of uniformity, but this is
not important.
EFFECT OF BILL ON REVIEW OF CASES IN THE COURT OF APPEALS OF
THE DISTRICT OF COLUMBIA
All cases from the Supreme Court of the District of Columbia
are, by the proposed law, appealable to the Court of Appeals of the
District, including all forms of cases, controversies, and proceed-
[P. 6]
ings in bankruptcy and cases in habeas corpus, and the judgments of
the Court of Appeals of the District are final therein, to be re-
viewed by the Supreme Court only by certiorari and certificate.
EFFECT OF BILL ON REVIEW OF CASES FROM COURT OF CLAIMS
The decisions of the Court of Claims are final, only to be reviewed
in the Supreme Court by certiorari or certificate.
REMEDIAL PROVISIONS
In addition to these changes in jurisdiction, there are in the pro-
posed bill some remedial amendments of a general character.
First. The time for application for writ of error or appeal or
certiorari to the Supreme Court has been enlarged from the pres-
ent limit of three months, and six months for the Philippines, by a
provision for a further allowance of 60 days upon order of a justice
-------
896 LEGAL COMPILATION—PESTICIDES
of the Supreme Court upon a proper showing.
Second. There is a reenactment of the present remedial provision
as to parol proof of amount in controversy, where it is necessary
for the jurisdiction and is not adequately shown either in the trial
court or in the appellate court.
Third. There is the remedial provision that if a man takes out
a writ or error when he should have taken out an appeal, or vice
versa, it shall be considered by the court to be a right writ. This is
at present the law; but in addition to this it is provided that where
one takes out a writ of error from the Supreme Court of the United
States to a State supreme court, and it turns out that it should
have been a certiorari, the writ of error may be considered by the
court as an application for certiorari and acted upon as such.
Fourth. There is a very necessary remedial provision for the
substitution in suits in the Supreme Court for public officers who
have ceased to be such, of their successors, as parties in suits
brought by them or against them. This is now the case with respect
to officers of the United States; but it is not the case with respect to
officers of the States, of the counties, or of the municipalities who
are plaintiffs or defendants in the Supreme Court. This is a great
injustice, because one may begin a suit in a district court of the
United States against officers of a State, county, or city, or such
officers may bring a suit therein, and not reach the Supreme Court
for review before their successors have been elected. Now, no sub-
stitution can be made, the case abates, and the action goes for
nothing. Under this provision, the new State, county, and city
officers may be substituted after notice to them and if such substi-
tution is shown not to work them injustice.
Fifth. There is another provision that takes away all rights of
corporations organized by Congress to seek the Federal court on
that ground. This enlarges a present provision of a similar tenor
which applies only to railway corporations.
THE WAY OP APPEAL WILL CEASE TO BE A "TRAP"
Besides the relief of the Supreme Court docket, and turning
aside a large number of cases from that court and making the
decisions of the circuit courts of appeals final in many cases and
only reviewable by certiorari—this bill should become a law be-
[P.7]
cause it clarifies and makes understandable the law governing
appeal whether by writ of error, appeal, or certiorari.
It was well said by the Chief Justice at the hearing that the
present laws are a "trap" in procedure.
This bill will simplify the law of appellate jurisdiction, relieve
-------
STATUTES AND LEGISLATIVE HISTORY 897
lawyers and litigants of uncertainties and perils which can not
always be avoided even by the well-equipped and trained prac-
titioner.
The statutes fixing the jurisdiction of the Supreme Court and
the circuit courts of appeals are to-day fragmentary. They are
scattered. Some are in the Revised Statutes of 1878; some in the
Judicial Code of 1911; and others consist of amendments appear-
ing here and there in many volumes of the Statutes at Large. They
are difficult to find and when found are neither harmonious nor
plain. Mr. Justice Van Devanter very forcefully pictured this state
of the law when he said in the hearing:
The circuit court of appeals act passed in 1891, besides defining the jurisdic-
tion of those courts, contained many provisions relating to the jurisdiction
of the Supreme Court. Most of these provisions and many amendatory enact-
ments were brought together advantageously in the Judicial Code of 1911.
But that was not a complete revision. It left some statutes, old ones, untouched
and did not bring them forward; so no one could examine the Judicial Code
and act safely merely upon what appeared there. It would be necessary to go
back and search the Revised Statutes and the intermediate Statutes at Large
to determine what course to pursue in invoking a review by either a circuit
court of appeals or the Supreme Court. Not only so, but the statutes when
found left it uncertain in some classes of cases in the district courts whether
the case could be carried directly to the Supreme Court or must go to the
circuit court of appeals.
Since the Judicial Code of 1911 many statutes have been enacted which bear
upon the jurisdiction of these courts—a statute would be adopted at one time
with respect to one class of cases, and another statute would be adopted at
another time with respect to another class. These statutes have been multiplied
until now they are not harmonious. Neither do they follow a consistent plan
or theory.
The situation now is that in the Supreme Court a good many cases have to
be dismissed, their merits left untouched, because they have been brought there
from a district court when they should have gone to a circuit court of appeals,
or because they have been brought from a circuit court of appeals on writ of
error or appeal when they could come up only on certiorari, or because they
have been brought from a State court on writ of error where certiorari was the
only admissible mode of bringing them up.
These mistakes are generally attributable to the fact that the practitioner
has found a part of the statues and not the rest. Sometimes the mistake is
mere carelessness; but it not infrequently happens that lawyers who stand
high in their profession at home mistake their remedy or the mode of invoking
it either because they do not find the controlling statute or because they have
difficulty in reconciling it with others.
Your committee expresses its deep obligation to the Chief Justice
and justices of the Supreme Court for their help not only in pre-
paring this bill but explaining it thoroughly.
The proposed legislation was recommended by the President in
his message of December 3, 1924, to the Congress. [p. 8]
-------
898
LEGAL COMPILATION—PESTICIDES
1.9b (2) CONGRESSIONAL RECORD, VOL. 66 (1925)
1.9b (2) (a) Feb. 2: Amended and passed House, pp. 2877-2880
[No Relevant Discussion on Pertinent Section]
1.9b (2) (b) Feb. 3: Amended and passed Senate, p. 2928
[No Relevant Discussion on Pertinent Section]
1.9b (2) (c) Feb. 4: House agreed to Senate amendments, p. 3005
JURISDICTION OF THE CIRCUIT COURTS OF
APPEALS AND OF THE SUPREME COURT
Mr. GRAHAM. Mr. Speaker, I call
up the bill (H. R. 8206) to amend the
Judicial Code and to further define the
jurisdiction of the circuit courts of ap-
peals and of the Supreme Court, and
for other purposes, with a Senate
amendment thereto, and move to con-
cur in the Senate amendment.
The Clerk read the Senate amend-
ment.
Mr. GRAHAM. Mr. Speaker, I yield
two minutes to the gentleman from
Texas. [Mr. BLANTON].
Mr. BLANTON. Mr. Speaker, the
last bill that was agreed to a moment
ago had all after the enacting clause
stricken out by the Senate, and then
a reenacting of our 19 pages of lan-
guage with one little change. We still
have a 19 page bill, but it has become
a Senate instead of a House bill. The
Senate has stricken out every word of
our bill after the enacting clause and
has then put back all of the language
of our bill, embracing nearly 20 pages,
except two little changes. Why was
that necessary? Some of the best law-
yers in the Nation are on this Judici-
ary Committee of the House. Are they
not able to write a bill that can be
passed into law without its being
stricken out? Why is it that every bill
we pass in the House and send to an-
other body, regardless of its size and
the number of its pages, has to have
all of it stricken out after the enacting
clause and practically the same lan-
guage put back into it page after page,
with just a few changes? Why do they
not insert their amendments in our
House bills? I am protesting against
their practice. It ought not to be con-
tinued. If a bill which we send to the
other body is meritorious but needs a
little change, the change ought to be
made by their amendment; they ought
not to rewrite word for word our entire
bill, and they ought not to require us
to read 19 pages of matter which they
insert and which they send back to us
to find out the changes they have made.
It puts double work on the committee
and it puts double work on the mem-
bership of the House and I hope that
they will stop it. [Applause.]
Mr. JONES. Mr. Speaker, will the
gentleman yield?
Mr. GRAHAM. Yes.
Mr. JONES. What changes did the
Senate make in the bill?
Mr. GRAHAM. They made one
change to meet the objection of the
gentleman from Illinois [Mr. DENI-
SON], made at the time we passed the
bill. I had given a promise that I would
help him introduce any change that
might be necessary to properly safe-
guard what he was seeking. He went
to the committee of judges and the
matter was agreed on, and two amend-
ments were inserted, and then there
was one formal amendment inserted
by the Senator from Massachusetts,
Mr. WALSH. Otherwise the bill is ex-
actly the same as it passed the House.
Mr. JONES. What was the other
amendment?
Mr. GRAHAM. The Judiciary Com-
mittee considered it and have author-
ized concurrence in the amendments
of the Senate, unanimously.
Mr. JONES. I understand the
amendment that the gentleman from
Illinois referred to, in respect to the
-------
STATUTES AND LEGISLATIVE HISTORY
899
jurisdiction of the Panama Canal, but
what does the other amendment refer
to?
Mr. GRAHAM. I can not point it out
as I have not the bill before me, but it
is a simple change. It does not involve
any organic change or even an im-
portant change. It was inserted to
satisfy the objection of Senator
WALSH.
The SPEAKER. The question is on
agreeing to the Senate amendment.
The Senate amendment was agreed
to. [p. 3005]
1.9c WRITS OF ERROR ABOLISHED AMENDMENTS
January 31,1928, P.L. 70-10, §1, 45 Stat. 54
CHAP. 14.—An Act In reference to writs of error.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, That the writ of
error in cases, civil and criminal, is abolished. All relief which
heretofore could be obtained by writ of error shall hereafter be
obtainable by appeal.
SEC. 2. That in all cases where an appeal may be taken as of right
it shall be taken by serving upon the adverse party or his attorney
of record, and by filing in the office of the clerk with whom the
order appealed from is entered, a written notice to the effect that
the appellant appeals from the judgment or order or from a speci-
fied part thereof. No petition of appeal or allowance of an appeal
shall be required: Provided, however, That the review of judg-
ments of State courts of last resort shall be petitioned for and
allowed in the same form as now provided by law for writs of error
to such courts.
Approved, January 31,1928. [p. 54]
1.9c (1) HOUSE COMMITTEE ON THE JUDICIARY
H.R. REP. No. 370, 70th Cong., 1st Sess. (1928)
IN REFERENCE TO WRITS OF ERROR
JANUARY 24,1928.—Referred to the House Calendar and ordered to be printed
Mr. DYER, from the Committee on the Judiciary, submitted the
following
REPORT
[To accompany S. 1801]
The Committee on the Judiciary to whom was referred the bill
S. 1801, after hearing (67th Cong., serial 25, p. 18) and consider-
ation, reports the same favorably and recommends that the bill
do pass.
-------
900
LEGAL COMPILATION—PESTICIDES
This bill is merely to simplify procedure by abolishing writs of
error and providing that the relief which heretofore could be
obtained by writ of error shall hereafter be obtainable by appeal.
It has been repeatedly indorsed by the American Bar Association.
[P.I]
1.9c (2) CONGRESSIONAL RECORD, VOL. 69 (1928)
1.9c (2) (a) Jan. 14: Discharged and passed Senate without
amendment, p. 1486
WRITS OF ERROR
The bill (S. 1801) in reference to
writs of error was considered as in
Committee of the Whole, and was read,
as follows:
Be it enacted, etc.. That the writ of error
in cases, civil and criminal, is abolished. All
relief which heretofore could be obtained by
writ of error shall hereafter be obtainable by
appeal.
SEC. 2. That in all cases where an appeal
may be taken as of right it shall be taken by
serving upon the adverse party or his attorney
of record, and by filing in the office of the clerk
with whom the order appealed from is entered,
a written notice to the effect that the appellant
appeals from the judgment or order or from
a specified part thereof. No petition of appeal
or allowance of an appeal shall be required:
Provided, however. That the review of judg-
ments of State courts of last resort shall be
petitioned for and allowed in the same form as
now provided by law for writs of error to such
courts.
Mr. WALSH of Montana. I may say
that this is a bill recommended by the
American Bar Association for the pur-
pose of simplifying the practice of get-
ting appeals into the Supreme Court
of the United States.
The bill was reported to the Senate
without amendment, ordered to be en-
grossed for a third reading, read the
third time, and passed.
[p.1486]
1.9c (2) (b) Jan. 25: Passed House, without amendment, p. 2040
[No Relevant Discussion on Pertinent Section]
1.9d DISTRICT OF COLUMBIA COURT OF APPEALS ACT
June 7, 1934, P.L. 73-298, 48 Stat. 926
[CHAPTER 426.]
AN ACT
To amend an Act of Congress approved February 9, 1893, entitled "An Act to
establish a court of appeals for the District of Columbia, and for other purposes."
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, That the court
established by the Act of February 9, 1893 (27 Stat. 434), entitled
"An Act to establish a court of appeals for the District of Colum-
bia, and for other purposes", shall hereafter be known as the
United States Court of Appeals for the District of Columbia.
Approved, June 7,1934.
[p. 926]
-------
STATUTES AND LEGISLATIVE HISTORY 901
1.9d (1) SENATE COMMITTEE ON THE JUDICIARY
S. REP. No. 917, 73rd Cong., 2d Sess. (1934)
TO CHANGE THE NAME OF THE COURT OF APPEALS TO
THE DISTRICT OF COLUMBIA TO THE UNITED STATES
COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA
APRIL 26 (calendar day, MAY 7), 1934.—Ordered to be printed
Mr. KING, from the Committee on the Judiciary, submitted the
following
REPORT
[To accompany S. 3524]
The Committee on the Judiciary, having had under considera-
tion the bill (S. 3524) to amend an act of Congress approved Feb-
ruary 9, 1893, entitled "An act to establish a court of appeals for
the District of Columbia, and for other purposes", report the same
favorably to the Senate and recommend that the bill do pass.
The sole purpose of this bill is to correct a misnomer in the title
of the court. The present title—"Court of Appeals of the District
of Columbia"—implies that the court is merely an appellate court
for matters arising in the District of Columbia. It has such local
appellate jurisdiction, but in addition its national jurisdiction is
broader than that of any other national court except the Supreme
Court of the United States. Among the national questions being
constantly considered by this court are those involving the Trans-
portation Act and the Interstate Commerce Act; mandamus pro-
ceedings in relation to Indian treaties; equity proceedings in rela-
tion to public lands; proceedings for the enforcement of the postal
laws; suits against the Federal Power Commission; suits against
the Civil Service Commission; suits against the Alien Property
Custodian; suits against the Federal Trade Commission; title to
patented public lands; appeals from the Board of Tax Appeals
without relation to the residence of the taxpayer; proceedings
under War Veterans' Act; proceedings in relation to irrigation
projects; proceeding's in relation to cancelation of mineral and oil
leases; proceedings in relation to the admission of aliens; the
enrollment of Indians; suits under the antitrust laws; and appeals
from the Radio Commission.
[p-1]
-------
902 LEGAL COMPILATION—PESTICIDES
1.9d (2) HOUSE COMMITTEE ON THE JUDICIARY
H.R. REP. No. 1748, 73rd Cong., 2d Sess. (1934)
TO CHANGE THE NAME OF THE COURT OF APPEALS
OF THE DISTRICT OF COLUMBIA
MAY 23,1934.—Referred to the House Calendar and ordered to be printed
Mr. SUMNERS, of Texas, from the Committee on the Judiciary,
submitted the following
REPORT
[To accompany H.R. 9437]
The Committee on the Judiciary, to whom was referred the bill
(H.R. 9437) to amend an act approved February 9, 1893, "An act
to establish a Court of Appeals for the District of Columbia, and
for other purposes," after consideration, report the same favorably
to the House with recommendation that the bill do pass.
This bill changes the name of the Court of Appeals of the Dis-
trict of Columbia to "The United States Court of Appeals for the
District of Columbia". It is felt that this change in name will help
to correct an erroneous impression which is frequently found to
exist among the laity, and the bar as well, that this court is simply
a local court of the District of Columbia, whereas, in fact, it is a
United States court with extensive national jurisdiction in addi-
tion to its jurisdiction as an appellate court of the District of
Columbia.
As pointed out by Mr. Justice Groner, one of the five members of
the court, the court deals with many questions which have no rela-
tion to the District of Columbia. These involve the Transportation
Act and the Interstate Commerce Act; mandamus proceedings in
relation to Indian treaties; equity proceedings in relation to pub-
lic lands; proceedings for the enforcement of the postal laws; suits
against the Federal Power Commission; suits against the Civil
Service Commission; suits against the Alien Property Custodian;
suits against the Federal Trade Commission; title to patented pub-
lic lands; appeals from the Board of Tax Appeals without relation
to the residence of the taxpayer; proceedings under War Veter-
ans' Act; proceedings in relation to irrigation projects; proceed-
ings in relation to cancelation of mineral and oil leases; proceedings
in relation to the admission of aliens; the enrollment of Indians;
suits under the antitrust laws; and appeals from the Radio Com-
mission, [p. 1]
-------
STATUTES AND LEGISLATIVE HISTORY 903
Mr. Justice Groner's communication addressed to the Chairman
of the Senate Committee on the Judiciary, which your committee
is advised expresses the views of the court, follows:
APRIL 25,1934.
Hon. WILLIAM H. KING,
United States Senate, Washington, D.C.
MY DEAR SENATOR KING: I enclose the bill making the change of name in the
Court of Appeals which Judge Van Orsdel and I spoke to you about this morn-
ing, and I wish again to thank you for your assurance that you would introduce
it tomorrow morning and have it acted on by the Judiciary Committee to which
you will have it referred next Monday. As the session will soon be over, the
element of time is of great importance.
The sole purpose of the bill is to correct a misnomer in the title of the court.
It creates no new office, adds no jurisdiction, and has no other purpose than
that mentioned above, but this is an important purpose, and its lack of notice
heretofore has been the cause of great misunderstanding on the part of the bar
of the importance of the court and its part in the Federal judicial system. It
is an appellate court for matters arising in the District of Columbia, just as
the Supreme Court of Utah is for matters arising in Utah, but this is only a
part of its jurisdiction and is the least part. Its national jurisdiction is broader
than that of any other national court, except the Supreme Court of the United
States. For instance, questions with no relation to the District of Columbia but
entirely national in their scope are constantly arising. These involve the
Transportation Act and the Interstate Commerce Act; mandamus proceedings
in relation to Indian treaties; equity proceedings in relation to public lands;
proceedings for the enforcement of the postal laws; suits against the Federal
Power Commission; suits against .the Civil Service Commission; suits against
the Alien Property Custodian; suits against the Federal Trade Commission;
title to patented public lands; appeals from the Board of Tax Appeals without
relation to the residence of the taxpayer; proceedings under War Veterans'
Act; proceedings in relation to irrigation projects; proceedings in relation to
cancelation of mineral and oil leases; proceedings in relation to the admission
of aliens; the enrollment of Indians; suits under the anti-trust laws; and
appeals from the Radio Commission.
The Supreme Court in a number of cases has declared the court is a court of
the United States. (See Benson v. Henkle, 198 U.S. 1; James v. United States,
202 U.S. 407, 408.) In the recent case of O'Donoghue v. United States (289
U.S. 516, 551), the Supreme Court said of the Court of Appeals: "It is a
constitutional court of the United States." And in another part of the same
opinion (p. 545) said of the Supreme Court and Court of Appeals of the
District of Columbia: "We take the true rule to be that they are courts of the
United States, vested generally with the same jurisdiction as that possessed
by the interior Federal courts located elsewhere in respect of the cases enum-
erated in section 2 of article III." And in Federal Trade Commission v.
Klesner (274 U.S. 145, 154), the Supreme Court said: "The courts of the
District of Columbia are Federal courts of the United States." And in the
same case (p. 156) : "The parallelism between the Supreme Court of the
District and the Court of Appeals of the District, on the one hand, and the
district courts of the United States and the circuit courts of appeals on the
other, * * * is complete." Many acts of Congress also refer to the courts as
"courts of the United States."
-------
904 LEGAL COMPILATION—PESTICIDES
If you will pardon a personal reference, Attorney General Mitchell told me,
as an inducement to leave the United States District Court for Virginia to
come to the Court of Appeals, that as a result of his 4 years as Solicitor Gen-
eral and his experiences as Attorney General he was of opinion that the Court
of Appeals was, after the Supreme Court of the United States, the most
important Federal court in the country. He was speaking, of course, from the
viewpoint of its general Federal jurisdiction, aftd this of course grows out of
its location at the seat of government.
The dignity of the court and its appeal to the highest grade lawyers in the
country when vacancies occur make the correction of this misnomer important,
and I very earnestly urge that you will take the matter under your considera-
tion to the end that it may be accomplished before the session ends.
Finally, may I add this statement? This court disposes of more cases each
year than any other Circuit Court of Appeals except the second (New York),
and the court is now up to date with its docket and the time required for a
hearing after the filing of the appeal is from 3 to 4 months, dependent upon
the time required for printing records and filing briefs.
Yours very cordially,
D. LAWRENCE GRONER
[p-2]
The Attorney General states that he has no objection to the pro-
posed change of name. A communication received by the chairman
of the committee from the Attorney General in this connection
follows:
DEPARTMENT OF JUSTICE
Washington, D.C., May 7, 1934
Hon. HATTON W. SUMNERS
Chairman Committee on the Judiciary, House of Representatives
MY DEAR MR. CHAIRMAN : I have your letter of May 3 in which you request
my comment on H.R. 9437, a bill to change the name of the Court of Appeals
of the District of Columbia to the United States Court of Appeals for the
District of Columbia.
In reply I wish to say that I know of no objection to the proposed change.
Sincerely yours,
HOMER CUMMINGS, Attorney General
[p-3]
1.9d (3) CONGRESSIONAL RECORD, VOL. 78 (1934)
1.9d (3) (a) May 10: Passed Senate, p. 8479
COURT OF APPEALS FOR THE DISTRICT
OF COLUMBIA
The Senate proceeded to consider the
bill (S. 3524) to amend an act of Con-
gress approved February 9, 1893, en-
titled "An act to establish a court of
appeals for the District of Columbia,
and for other purposes."
Mr. ROBINSON of Arkansas. The
report states that the object in chang-
ing the name of this court?
Mr. KING. Mr. President, I was re-
quested to introduce this bill by the
judges of the court. It changes the
name from the "Court of Appeals of
the District of Columbia" to the
"United States Court of Appeals for
the District of Columbia."
-------
STATUTES AND LEGISLATIVE HISTORY
905
Mr. ROBINSON of Arkansas. The
report states that the present title
"Court of Appeals of the District of
Columbia" implies that the court is
merely an appellate court for matters
arising in the District of Columbia,
whereas it exercises other jurisdiction.
Mr. KING. Exactly.
Mr. ROBINSON of Arkansas. I have
no objection.
Mr. KING. Much of the business of
the court comes now from outside the
District, and therefore its duties are
of a broader nature than implied by
the name, "Court of Appeals of the
District of Columbia."
The bill was ordered to be engrossed
for a third reading, read the third
time, and passed, as follows:
Be it enacted, etc., That the court estab-
lished by the act of February 9, 1893 (27 Stat.
434), entitled "An act to establish a court of
appeals for the District of Columbia, and for
other purposes", shall hereafter be known as
the United States Court of Appeals for the
District of Columbia.
[p. 8479]
1.9d (3) (b) June 5: Passed House, pp. 10536-10537
[No Relevant Discussion on Pertinent Section]
1.9e COURT OF APPEALS REVIEW ACT
June 25,1948, P.L. 80-773, §1254, 62 Stat. 928
§1254. Courts of appeals; certiorari; appeal; certified questions
Cases in the courts of appeals may be reviewed by the Supreme
Court by the following methods:
(1) By the writ of certiorari granted upon the petition of any
party to any civil or criminal case, before or after rendition of
judgment or decree;
(2) By appeal by a party relying on a State statute held by a
court of appeals to be invalid as repugnant to the Constitution,
treaties or laws of the United States, but such appeal shall pre-
clude review by writ of certiorari at the instance of such appellant,
and the review on appeal shall be restricted to the Federal ques-
tions presented;
(3) By certification at any time by a court of appeals of any
question of law in any civil or criminal case as to which instruc-
tions are desired, and upon such certification the Supreme Court
may give binding instructions or require the entire record to be
sent up for decision of the entire matter in controversy.
[p. 928]
-------
906 LEGAL COMPILATION—PESTICIDES
1.9e (1) HOUSE COMMITTEE ON THE JUDICIARY
H.R. REP. No. 308, 80th Cong., 1st Sess. (1947)
REVISION OF TITLE 28, UNITED STATES CODE
APRIL 25,1947.—Ordered to be printed
Mr. ROBISON, from the committee on the Judiciary, submitted the
following
REPORT
[To accompany H.R. 3214]
The Committee on the Judiciary submits the following report in
explanation of the bill (H.R. 3214) to revise, codify, and enact
into law title 28 of the United States Code entitled "Judicial Code
and Judiciary," and recommends that the bill do pass. The present
bill has been substituted for an earlier bill (H.R. 2055) on which
hearings were held and contains changes recommended by the
subcommittee.
PRELIMINARY STATEMENT
SCOPE OF REVISION
The source material of this revision was the Judicial Code of
1911 constituting, in part, title 28 of the United States Code. To
this were added appropriate sections from other titles which could
be transferred without impairing the framework of the official
United States Code prepared by the former Committee on Revi-
sion of the Laws of the House and enacted by Congress in 1926.
This revision includes all applicable laws in effect March 10,
1947.
Before actual revision was begun a scientific plan was assembled.
This included:
1. The complete text of title 28, United States Code, 1940 edition,
and the latest supplement thereto.
2. Pertinent provisions from other titles of the code.
3. Complete text of original acts set out in the Statutes at Large.
4. Applicable constructions by the courts.
5. Notes based upon a careful examination of the Code of Fed-
eral Regulations and law reviews.
6. Exhaustive historical notes.
7. Notes on the Rules of Civil Procedure and Rules of Criminal
Procedure promulgated by the Supreme Court. .- 1 -,
8. Suggestions from the bench and bar.
Revision, as distinguished from codification, required the substi-
-------
STATUTES AND LEGISLATIVE HISTORY 907
tution of plain language for awkward terms, reconciliation of con-
flicting laws, repeal of superseded sections, and consolidation of
related provisions.
HISTORY OF THE JUDICIAL CODE
The first law establishing the Federal courts and regulating
their jurisdiction and procedure was enacted at the first session of
the First Congress. This law of September 24, 1789 (ch. 21,1 Stat.
73), is popularly known as the Judiciary Act of 1789.
This first judicial code was very brief. It comprised only 35 sec-
tions. But the Nation itself was small, with a population of only
3,000,000.
From the beginning the body of the law relating to the courts
and judicial officers and their procedure developed gradually by
unrelated acts, without any real effort to reconcile conflicting pro-
visions of successive enactments. At the outbreak of the Civil War
the Statutes at Large numbered 12 volumes. That war and the
reconstruction period which followed gave impetus to Federal
legislation.
The whole of the expanding body of Federal law was carefully
examined by the commissioners empowered by Congress in 1866
to prepare the Revised Statutes of the United States. Obsolete and
superseded provisions, which had accumulated during the 88-year
period from 1789 to the date of the final approval of the Revised
Statutes in 1877, were repealed. Inconsistent provisions were re-
conciled and all existing laws relating to the courts were analyzed,
revised, and consolidated into title XIII, of the Revised Statutes,
entitled "The Judiciary," comprising 21 chapters and 564 sections.
The Judicial Code of 1911 was enacted into law by act March 3,
1911 (ch. 231, 36 Stat. 1152), after long and exhaustive study by
the same commission that drafted the Criminal Code of 1909.
In preparing the Judicial Code of 1911 the commissioners dis-
carded the analysis and arrangement used in the Revised Statutes.
Statutes were revised and consolidated, obsolete laws were repealed
and improvements were introduced. The old circuit courts were
abolished and their jurisdiction transferred to the district courts.
Thirty-six years have passed since the enactment of the Judicial
Code of 1911. That is a longer time than elapsed between the revi-
sions of 1878 and 1911. It comprises a period which witnessed
unprecedented changes on the national scene. During those years
the population of the United States leaped from 91,000,000 to
140,000,000 and the Nation twice experienced the tremendous
social changes that accompany world wars. It is a tribute to Con-
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908 LEGAL COMPILATION—PESTICIDES
gress and to the draftsmen of the Judicial Code of 1911 that our
judicial system has withstood the impact of these terrific changes.
However, there is little doubt that the changes of the past 36 years
make imperative this revision of the Judicial Code. r „-,
SECTION 1254—SECTION REVISED
Based entitle 28, U.S.C., 1940 ed., §§346 and 347 (Mar. 3, 1911,
ch. 231, §§239, 240, 36 Stat. 1157; Feb. 13, 1925, ch. 229, §1, 43
Stat. 938; Jan. 31, 1928, ch. 14, §1, 45 Stat. 54; June 7, 1934, ch.
426, 48 Stat. 926).
Section consolidates sections 346 and 347 of title 28, U.S.C.,
1940 ed.
Words "or in the United States Court of Appeals for the District
of Columbia" and "or of the United States Court of Appeals for the
District of Columbia" in sections 346 and 347 of title 28, U.S.C.,
1940 ed., were omitted. (See section 41 of this title.)
The prefatory words of this section preceding paragraph (1)
were substituted for subsection (c) of said section 347.
The revised section omits the words of section 347 of title 28,
'U.S.C., 1940 ed., "and with like effect as if the case had been
brought there with unrestricted appeal", and the words of section
346 of such title "in the same manner as if it had been brought
there by appeal". The effect of subsections (1) and (3) of the
revised section is to preserve existing law and retain the power
of unrestricted review of cases certified or brought up on certio-
rari. Only in subsection (2) is review restricted.
Changes were made in phraseology and arrangement.
[p. A107]
1.9e (2) SENATE COMMITTEE ON THE JUDICIARY
S. REP. No. 1559, 80th Cong., 2d Sess. (1948)
REVISING, CODIFYING, AND ENACTING INTO LAW TITLE
28 OF THE UNTED STATES CODE, ENTITLED "JUDICIAL
CODE AND JUDICIARY"
JUNE 9 (legislative day, JUNE 1), 1948.—Ordered to be printed
Mr. WILEY, from the Committee on the Judiciary, submitted the
following
REPORT
[To accompany H.R. 3214]
The Committee on the Judiciary, to whom was referred the bill
(H.R. 3214) to revise, codify, and enact into law title 28 of the
-------
STATUTES AND LEGISLATIVE HISTORY 909
United States Code, entitled "Judicial Code and Judiciary," having
considered the same, do now report the bill to the Senate favor-
ably, with amendments, and recommend that the bill, as amended,
do pass.
The purpose of the bill is to codify and revise the laws relating
to the Federal judiciary and judicial procedure.
No revision of these laws has been made since 1911, and the
Judicial Code enacted in that year did not include all the laws upon
the subject.
A tremendous amount of additional legislation in this field has
been enacted since 1911. Consequently, there is now a great mass
of statutory material upon this subject, much of which is archaic,
ambiguous, conflicting, and to an unascertained extent repealed by
implication by later statutes. These statutes are scattered through
many volumes of the Statutes at Large which are not easily access-
ible to the bench and bar. Moreover, many of the statutes relating
to procedure appearing in the books have been rendered wholly
obsolete by the Federal Rules of Civil Procedure prescribed by the
Supreme Court. This situation results in the loss of much time
and effort on the part of the bench and bar in determining what is
the present law in this field, always at the risk of possible error.
It is evident, therefore, that a thorough codification and revision
of the statutes relating to the judiciary and its procedure is very
much in the public interest in order that the law in this important
field may be clear, certain, and readily available.
The bill H.R. 3214 accomplishes these desirable results. The
statutory material presently in force has been arranged in the bill
in a logical and consistent way, rendering it easily ascertainable.
[p.l]
Existing inconsistencies and ambiguities have been removed and
obsolete and archaic provisions eliminated or modernized.
By enacting this bill into positive law as title 28 of the United
States Code, that title will thereby become the law rather than
merely presumptive evidence of the law, and reference to prior
volumes of the Statutes at Large will be rendered wholly unneces-
sary.
Many noncontroversial improvements have been effected which,
while individually small in themselves, add up to a very substan-
tial improvement in and modernization of the law relating to the
Federal judiciary. At the same time great care has been exercised
to make no changes in the existing law which would not meet with
substantially unanimous approval.
The bill with the amendments proposed by the committee
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910 LEGAL COMPILATION—PESTICIDES
includes all pertinent laws to January 5, 1948, and the bill pro-
vides for it to become effective September 1, 1948, thus allowing
an interval in which the bench and bar may become acquainted
with the revised arrangement of the law.
The report of the Committee on the Judiciary of the House of
Representatives upon the bill (H. Kept. No. 308, 80th Cong., 1st
sess.) describes in detail the scope of the revision, the manner in
which it was carried out by the House Committee on the Judiciary
and its predecessor, the House Committee on Revision of the Laws,
and the principal improvements effected. Appended to the report
are the revisers' notes to each section, together with accompanying
tables. These explain in great detail the source of the law and the
changes made in the course of the codification and revision.
As passed by the House of Representatives, the bill included pro-
visions covering the Tax Court of the United States. These pro-
posed to transfer that court from the Internal Revenue Code, title
26, United States Code, to the Judicial Code. This proposed trans-
fer of the Tax Court to the Judicial Code has proved controversial
with respect to the court and as to those who are entitled to prac-
tice before it. Since every effort has been made to avoid controver-
sial matters in this revision, the committee recommends that all
Tax Court provisions be omitted from this bill.
One of the changes proposed by the House of Representatives
with respect to the Tax Court provided that Tax Court decisions
should be reviewable on appeal to the same extent as similar deci-
sions of the district courts. This in effect repeals the contrary rule
laid down in Dobson v. Commissioner of Internal Revenue (320
U. S. 489). This proposal met with unanimous approval at the
hearings on the bill held by your committee. It is recommended
that the House amendment be retained. In view of the elimination
of the Tax Court from the bill, this must be accomplished by an
amendment of the Internal Revenue Code. Such an amendment is
included among the committee amendments.
The amendments proposed by the committee, together with the
reasons for each, are listed below.
[p. 2]
1.9e (3) CONGRESSIONAL RECORD
1.9e (3) (a) VOL. 93 (1947), July 7: Passed House, p. 8392
[No Relevant Discussion on Pertinent Section]
-------
STATUTES AND LEGISLATIVE HISTORY 911
1.9e(3) (b) VOL. 94 (1948), June 12: Amended and passed Senate,
p.7927
[No Relevant Discussion on Pertinent Section]
1.9e (3) (c) VOL. 94 (1948), June 16: House concurs in Senate
amendments, p. 8501
[No Relevant Discussion on Pertinent Section]
1.10 ADULTERATED FOOD, AS AMENDED
21U.S.C. §342 (a)
[Referred to in 21 U.S.C. §§346, 346a (a), 348(a) (2)]
ADULTERATED FOOD
§342
A food shall be deemed to be adulterated—
Poisonous, insanitary, etc., ingredients
(a) (1) If it bears or contains any poisonous or deleterious
substance which may render it injurious to health; but in case the
substance is not an added substance such food shall not be consid-
ered adulterated under this clause if the quantity of such substance
in such food does not ordinarily render it injurious to health; or
(2) (A) if it bears or contains any added poisonous or added dele-
terious substance (other than one which is (i) a pesticide chemi-
cal in or on a raw agricultural commodity; (ii) a food additive;
(iii) a color additive; or (iv) a new animal drug) which is unsafe
within the meaning of section 346 of this title, or (B) if it is a raw
agricultural commodity and it bears or contains a pesticide chemi-
cal which is unsafe within the meaning of section 346a (a) of this
title, or (C) if it is, or it bears or contains, any food additive
which is unsafe within the meaning of section 348 of this title:
Provided, That where a pesticide chemical has been used in or on
a raw agricultural commodity in conformity with an exemption
granted or a tolerance prescribed under section 346a of this title
and such raw agricultural commodity has been subjected to proc-
essing such as canning, cooking, freezing, dehydrating, or milling,
the residue of such pesticide chemical remaining in or on such
processed food shall, notwithstanding the provisions of sections
346 and 348 of this title, not be deemed unsafe if such residue in
or on the raw agricultural commodity has been removed to the
extent possible in good manufacturing practice and the concentra-
tion of such residue in the processed food when ready to eat is not
greater than the tolerance prescribed for the raw agricultural
commodity, or (D) if it is, or it bears or contains, a new animal
drug (or conversion product thereof) which is unsafe within the
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912 LEGAL COMPILATION—PESTICIDES
meaning of section 360b of this title; or (3) if it consists in whole
or in part of any filthy, putrid, or decomposed substance, or if it is
otherwise unfit for food; or (4) if it has been prepared, packed, or
held under insanitary conditions whereby it may have become con-
taminated with filth, or whereby it may have been rendered in-
jurious to health; or (5) if it is, in whole or in part, the product
of a diseased animal or of an animal which has died otherwise
than by slaughter; or (6) if its container is composed, in whole or
in part, of any poisonous or deleterious substance which may ren-
der the contents injurious to health; or (7) if it has been inten-
tionally subjected to radiation, unless the use of the radiation was
in conformity with a regulation or exemption in effect pursuant
to section 348 of this title.
June 25, 1938, c. 675, § 402, 52 Stat. 1046; 1940 Reorg. Plan No.
IV, § 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; Mar. 16,
1950, c. 61, § 3(d), 64 Stat. 21; 1953 Reorg. Plan No. 1, §§ 5, 8,
eff. April 11, 1953, 18 F.R. 2053, 67 Stat. 631; July 22, 1954, c.
559, § 2, 68 Stat. 511; July 9, 1956, c. 530, 70 Stat. 512; Sept. 6,
1958, Pub.L. 85-929, § 3(a), (b), 72 Stat. 1784; Mar. 17, 1959,
Pub.L. 86-2, 73 Stat. 3, July 12, 1960, Pub.L. 86-618, Title I,
§§ 102(a) (1), (2), 105(c), 74 Stat. 397, 404; and amended June
29,1966, Pub.L. 89-477, 80 Stat. 231; July 13, 1968, Pub.L. 90-399,
§ 104, 82 Stat. 352.
l.lOa FEDERAL FOOD, DRUG, AND COSMETIC ACT
June 25, 1938, P.L. 75-717, §402, 52 Stat. 1046
ADULTERATED FOOD
SEC. 402. A food shall be deemed to be adulterated—
(a) (1) If it bears or contains any poisonous or deleterious sub-
stance which may render it injurious to health; but in case the
substance is not an added substance such food shall not be consid-
ered adulterated under this clause if the quantity of such substance
in such food does not ordinarily render it injurious to health; or
(2) if it bears or contains any added poisonous or added deleteri-
ous substance which is unsafe within the meaning of section 406;
or (3) if it consists in whole or in part of any filthy, putrid, or
decomposed substance, or if it is otherwise unfit for food; or (4)
if it has been prepared, packed, or held under unsanitary conditions
whereby it may have become contaminated with filth, or whereby
it may have been rendered injurious to health; or (5) if it is, in
whole or in part, the product of a diseased animal or of an animal
"which has died otherwise than by slaughter; or (6) if its con-
tainer is composed, in whole or in part, of any poisonous or dele-
-------
STATUTES AND LEGISLATIVE HISTORY 913
terious substance which may render the contents injurious to
health.
(b) (1) If any valuable constituent has been in whole or in part
omitted or abstracted therefrom; or (2) if any substance has been
substituted wholly or in part therefor; or (3) if damage or inferi-
ority has been concealed in any manner; or (4) if any substance
has been added thereto or mixed or packed therewith so as to
increase its bulk or weight, or reduce its quality or strength, or
[p.1046]
make it appear better or of greater value than it is.
(c) If it bears or contains a coal-tar color other than one from a
batch that has been certified in accordance with regulations as pro-
vided by section 406: Provided, That this paragraph shall not apply
to citrus fruit bearing or containing a coal-tar color if application
for listing of such color has been made under this Act and such
application has not been acted on by the Secretary, if such color
was commonly used prior to the enactment of this Act for the
purpose of coloring citrus fruit.
(d) If it is confectionery, and it bears or contains any alcohol
or nonnutritive article or substance except harmless coloring, harm-
less flavoring, harmless resinous glaze not in excess of four-tenths
of 1 per centum, natural gum, and pectin: Provided, That this
paragraph shall not apply to any confectionery by reason of its
containing less than one-half of 1 per centum by volume of alcohol
derived solely from the use of flavoring extracts, or to any chewing
gum by reason of its containing harmless nonnutritive masticatory
substances. [p
l.lOa (1) SENATE COMMITTEE ON COMMERCE
S. REP. No. 91, 75th Cong., 1st Sess. (1937)
FOOD, 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, for-
eign, and other commerce subject to the jurisdiction of the United
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914 LEGAL COMPILATION—PESTICIDES
States, for the purposes of safeguarding the public health, pre-
venting deceit upon the purchasing public, and for other purposes,
having considered the same, report thereon with certain amend-
ments, 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 the 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.
This bill meets these three principles. It has been prepared after
many and extensive conferences with the enforcement agencies of
the Government and with representatives of various consumer
groups or associations, professional groups, and the industries to
be regulated.
Separately called meetings were held with representatives of the
food, drug, and cosmetic industries. Letters inviting suggestions
were sent to many persons known to be interested in the subject.
Several volumes of suggestions have been received from persons in
the groups just mentioned. These suggestions have been carefully
studied; many of them rejected; some accepted; some accepted in
part or in effect. The hearings which have been held by committees
of the Senate and House of Representatives on previous bills in
former sessions of the Congress have been reviewed and studied to
take advantage of the information and discussions contained
in them. [p t]
The legislative effort to secure a better law on this subject began
in June 1933, with the introduction of S. 1944. Since that time
there have been many bills and many revisions of bills. There have
been numerous hearings by committees of the Congress. The sub-
ject has been debated on the floors of Congress, in the press,
throughout the industries, and by the public. This study has gone
on over a period of 31/2 years. In the preparation of the present
bill there has been an earnest, painstaking effort to take advantage
of what light has been shed from these various courses.
This bill is presented with the confident assurance that, insofar
as it is possible, all the known facts have been utilized, and that the
measure is capable of accomplishing the purposes declared for it.
And it is a fair bill which will enable honest business to be carried
on without interference, except such as is necessary to safeguard
the public health.
It must be realized that the preparation of a bill which affects
so many and such varied industrial interests in intricate and tech-
-------
STATUTES AND LEGISLATIVE HISTORY 915
nical particulars, and which concerns and appeals to so many,
including consumers and others not immediately in the businesses
affected, necessarily presents a task of almost indescribable diffi-
culty. It is only natural that many emphasize their immediate
concerns without proportionate regard to the rights of others in
matters which do not directly interest them. Many advance their
particular interests without consideration for the technical and
legal requirements that are presented in the preparation of a bill.
Conflict also develops in the clash of extreme positions. There
are some who would give no regard whatever to the fairness of the
bill's application to business. Unforunately, there are some who
give no regard, or very little, to the effectiveness of the bill for
protection of the consumer. It should be said with emphasis that
all business does not fall in that latter class. Business has not been
unsympathetic to the effort for a better law. Strong support for a
better law exists in the industries affected.
Considering the variety and diversity of interest, the unavoida-
ble controversies that honestly arise among these interests, a so-
called "perfect" bill hardly can be formulated. This bill is not a
thing of perfection. It simply represents an earnest effort to serve
its declared purposes. It is introduced in the hope that all who
desire to see its purposes accomplished and all who are friends of
the movement for a better law, will give it unbiased, impartial, and
careful consideration, and, after so doing, will see their way clear
to support and advocate its enactment.
It will be noted that the sequence has been changed from that of
previous bills. This has been done with a view to making it simpler
to read, both while it is a bill and later as a law, when it will be
constantly examined by enforcement officials, courts, and lawyers.
It was thought that it would be an advantage to have the prohib-
ited acts and the enforcement machinery put in the forepart of the
bill so that one may quickly learn those requirements, and then
move deeper into the bill for details on the particular problem in
wh;ch he is interested.
The bill has been made shorter and less verbose than previous
bills. That has been done without deleting any effective provisions.
[p. 2]
It has been done by avoiding unnecessary repetitions which existed
in previous bills, and by consolidating at a single place in a few
lines what appeared heretofore at several different places.
That was also accomplished by eliminating some provisions
which, while lending nothing to the strength of the bill, presented
the possibility of confusion in enforcement and perhaps raised
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916 LEGAL COMPILATION—PESTICIDES
the issue of its constitutionality. For instance, the requirement
that claims for drug products should be supported by medical opin-
ion was deleted. Great difficulty always has been found in defining
"medical opinion". In one State, certain practitioners are licensed
and their opinions would be considered medical opinion, whereas
in another State such practitioners would not be licensed. Further-
more, as shown, in the previous discussions, it would often be
impossible to determine what the state of medical opinion is on
controverted subjects.
When those considerations were added to the possibility that the
guilty might escape through the uncertainties of such a provision,
and the strong likelihood that courts would invalidate a statute
making medical opinion the criterion of truth and the gage of a
criminal offense, the provision was deleted. The bill is stronger
for the deletion. Medical testimony can and will be adduced in
enforcing the law. It will be received as evidence. But, the bill will
avoid the danger of making it a legal standard, usually undeter-
minable, the violation of which incurs criminal penalties.
The bill also includes a provision that a drug shall be deemed to
be misbranded if it is dangerous to health when used in the dosage,
or with the frequency or duration, prescribed or recommended in
the labeling or advertising thereof. That provision has been in pre-
vious bills.
The controversial subject of control of advertising has been met
by providing for the prohibition of false advertising by injunction.
The bill also states differently the offense of false advertisement.
Previous bills have defined false advertisements as those which are
"false or misleading in any particular". That definition has occa-
sioned no end of controversy—some of it quite meritorious—on
the ground that when applied to the unlimited field of advertising
it was too elastic and encompassed things far beyond the purposes
of the bill. Also, it would lend itself to unnecessary and unjustified
governmental interference in the affairs of business, and impose
upon the Government a job far beyond the Government's financial
and personnel capacities to enforce. The statement of the offense
in the bill defines those subjects pertaining to food, drugs, and
cosmetics which should be under Government control.
There has been controversy as to whether the Food and Drug
Administration or the Federal Trade Commission should enforce
the bill's provisions on advertising. On the premise that advertise-
ments of foods, drugs, and cosmetics are nothing more than exten-
sions of the labeling, this bill proposes that the control be vested
in the Food and Drug Administration which enforces the provi-
-------
STATUTES AND LEGISLATIVE HISTORY 917
sions on adulteration and labeling. But, it does not have the effect
of depriving the Federal Trade Commission of its jurisdiction to
proceed against false advertising in such form as to make it an
unfair method of competition. The bill specifically provides that it
shall not be construed as impairing or diminishing the powers of
the Federal Trade Commission.
[P- 3]
The bill simply provides that the district courts of the United
States shall have the power to grant temporary and permanent
injunctions against the dissemination of any advertisement which
contains—
any representation regarding any food, drug, device, or cosmetic, or the ingre-
dients thereof, or the substances therein, or the identity, strength, quality,
purity, quantity, origin, source, harmlessness, or safety thereof, or the nutri-
tional, dietary, curative, therapeutic, preventive, diagnostic, or beneficial effects
thereof, or the safety or efficiency of the dosage, frequency, or duration of use
pertaining thereto, which is false or misleading in any material particular.
It is submitted that that is a perfectly proper power to vest in the
district courts of the United States, and that it not only is proper,
but necessary, that the Food and Drug Administration which has
foods, drugs, and cosmetics under observation, shall be authorized
to seek such injunctions at the hands of the courts. No one can dis-
pute that such advertisements should be enjoined. The fact that the
Federal Trade Commission may proceed against advertisers using
unfair methods of competition should not prevent the grant to the
Food and Drug Administration of this additional, necessary, and
very desirable power to protect the public against advertisements
which bear directly on public health.
The provisions of the previous bills with respect to seizure also
have been subject to much controversy. Again, it has been
attempted to take advantage of what has been learned in previous
studies. This bill permits multiple seizures of any food, drug,
device, or cosmetic that is adulterated. It permits multiple seizures
for misbranding when the misbranding has been the basis of a
prior judgment in favor of the Government, or when the Secretary
of Agriculture has probable cause to believe, from facts found by
him, that the misbranding renders the article dangerous to health.
The only limitation is that misbranding which does not render
an article dangerous to health, shall not be handled by multiple
seizures made at the will of enforcement officers. That has been the
declared policy of the Food and Drug Administration in enforcing
the existing law. The bill therefore does no more than write into
the law what is declared to be the policy of the Administration. But
it is important that that policy be written into the bill because it
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918 LEGAL COMPILATION—PESTICIDES
is the proper policy, and because succeeding administrations should
be held to that policy.
There is no comparison between this bill and the existing law as
to the extent of their respective applications and the extent of the
enforcement officers' powers under them. Where the existing law is
entirely negative in its labeling requirements, this bill is affirma-
tive. Where the existing law limits its attacks against misbranding
on therapeutic matters to statements which are false and fraudu-
lent, this bill expands them to those which are false or misleading.
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 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 misbrand-
ing over those in the existing law, and adds injunction, temporary
and permanent, as a means of prohibiting adulteration and mis-
branding. The existing 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
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:
ADVERTISING
1. Prohibits false advertising of food, drugs, therapeutic devices,
and cosmetics.
FOODS
2. Provides for the promulgation of standards of identity and a
reasonable standard of quality for food. (A standard of quality i?
authorized by the present law for canned food only.)
3. Requires the labeling of unstandardized food to disclose the
ingredients by name.
4. Prohibits traffic in food which is dangerous to health. (The
present law permits regulation of dangerous food only in the even
that the poison is added.)
5. Prohibits addition of poison. If it cannot be avoided in pro
-------
STATUTES AND LEGISLATIVE HISTORY 919
duction or manufacture, when it reaches the consumer the product
must be safe for human use.
6. Eliminates the "distinctive name" proviso of the existing law
under which the sale of products, the labels of which are mislead-
ing, are now permitted sale.
7. Requires fully informative labeling of infant and invalid
food.
8. Requires label declaration of artificial colors and artificial
flavors in food.
9. Forbids traffic in confectionery containing metallic trinkets
and other inedible substances which have been found to be a men-
ace to the welfare of children.
10. Authorizes emergency license control of food that might be
dangerous by reason of contamination with micro-organisms. Such
licensing is limited to operations in which the public health cannot
be protected otherwise.
COSMETICS
11. For the first time places cosmetics under Federal supervi-
sion. Requiring cosmetics to be truthfully sold and outlaws those
injurious to health.
DRUGS
12. Prohibits traffic in drugs and devices which are dangerous
to health under the conditions of use prescribed in the labeling or
advertising.
13. Requires habit-forming drugs to bear warning labels.
14. Requires adequate directions for use of drugs and devices
and appropriate warnings against their probable misuse through
overdosage, or by children, or in disease conditions where they
may be dangerous.
[p. 5]
15. Sets up special protection to consumers against drugs liable
to deterioration.
16. Requires that claims of effect of drugs and devices must not
be false or misleading in any material particular. (The present law
makes fraud, that is, wilful intent to deceive, an element of the
offense; unwarranted therapeutic claims resulting from sheer
ignorance of the manufacturer are not actionable.)
17. Defines "nonofficial" drugs as illegal if the standard of
strength varies from the standard claimed. (The present law pre-
scribes only those which fall below the standard claimed. Drugs
which are too strong may be quite dangerous.)
18. Requires that antiseptics possess germicidal power.
-------
920 LEGAL COMPILATION—PESTICIDES
19. Requires declaration on the label of the names of active
ingredients of nonofficial drugs.
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 rec-
ords needed to prove Federal jurisdiction.
25. Provides increased penalties for violations.
26. Authorizes the Federal courts to enjoin violations.
[p. 6]
l.lOa (2) 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 jurisdiction
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 recom-
mend 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.
-------
STATUTES AND LEGISLATIVE HISTORY 921
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. T 1-,
IP-1]
Sections 402 and 403 define, respectively, adulterated food and
misbranded food. They contain new provisions not found in the old
law but the need for which has been very definitely demonstrated
[p. 5]
through enforcement proceedings under the old law. Primarily
these new provisions provide control against unsanitary and con-
taminated foods, foods packed in poisonous containers, various
forms of food debasement, and provide for more informative label-
ing of foods. [p. 6]
l.lOa (3) 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
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 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:
-------
922 LEGAL COMPILATION—PESTICIDES
In lieu of the matter proposed to be inserted by the House
amendment insert the following:
Chapter I—Short Title
Section 1. This Act may be cited as the Federal Food, Drug, and
Cosmetic Act.
Chapter II—Definitions
*******
[p.l]
Chapter IV—Food
Adulterated Food
Sec. 402. A food shall be deemed to be adulterated—
(a) (1) If it bears or contains any poisonous or deleterious sub-
stance which may render it injurious to health; but in case the
substance is not an added substance such food shall not be consid-
ered adulterated under this clause if the quantity of such substance
in such food does not ordinarily render it injurious to health; or
(2) if it bears or contains any added poisonous or added deleterious
substance which is unsafe within the meaning of section 406; or
(3) if it consists in whole or in part of any filthy, putrid, or decom-
[p. 7]
posed substance, or if it is otherwise unfit for food; or (4) if it has
been prepared, packed, or held under insanitary conditions
whereby it may have become contaminated with filth, or whereby
it may have been rendered injurious to health; or (5) if it is, in
whole or in part, the product of a diseased animal or of an animal
which has died otherwise than by slaughter; or (6) if its container
is composed, in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health.
(b) (1) If any valuable constituent has been in whole or in part
omitted or abstracted therefrom; or (2) if any substance has been
substituted wholly or in part therefor; or (3) if damage or inferi-
ority has been concealed in any manner; or (4) if any substance
has been added thereto or mixed or packed therewith so as to
increase its bulk or weight, or reduce its quality or strength, or
make it appear better or of greater value than it is.
(c) If it bears or contains a coal-tar color other than one from a
batch that has been certified in accordance with regulations as pro-
vided by section 406: Provided, That this paragraph shall not
apply to citrus fruit bearing or containing a coal-tar color if appli-
cation for listing of such color has been made under this Act and
-------
STATUTES AND LEGISLATIVE HISTORY
923
such application has not been acted on by the Secretary, if such
color was commonly used prior to the enactment of this Act for
the purpose of coloring citrus fruit.
(d) If it is confectionery, and it bears or contains any alcohol
or nonnutritive article or substance except harmless coloring,
harmless flavoring, harmless resinous glaze not in excess of four-
tenths of 1 per centum, natural gum, and pectin: Provided, That
this paragraph shall not apply to any confectionery by reason of
its containing less than one-half of 1 per centum by volume of alco-
hol derived solely from the use of flavoring extracts, or to any
chewing gum by reason of its containing harmless nonnutritive
masticatory substances.
[p. 8]
l.lOa (4) CONGRESSIONAL RECORD
l.lOa (4) (a)
ate, p. 2009
The PRESIDING OFFICER. The
next amendment will be stated.
The next amendment of the Com-
mittee on Commerce was under the
subtitle "Adulterated food", in section
11, paragraph (a), on page 20, line 7,
after the word "section", to strike out
"15, or in excess of the limits of toler-
ance prescribed by regulations as pro-
vided by section", so as to make the
paragraph read:
ADULTERATED FOOD
SEC. 11. A food shall be deemed to be adul-
terated—
(a) (1) If it bears or contains any poisonous
or deleterious substance which may render it
dangerous to health; or (2) if it bears or con-
tains any added poisonous or added deleterious
substance which may render it injurious to
health, or which is unsafe within the meaning
of section 15; or (3) if it consists in whole or
in part of any filthy, putrid, or decomposed
substance, or if it is otherwise unfit for food ; or
(4) if it has been prepared, packed, or held
under insanitary conditions whereby it may
have become contaminated with filth, or
VOL. 81 (1937), March 9: Amended and passed Sen-
whereby it may have been rendered injurious
to health; or
(6) if it is, in whole or in part, the product of a
diseased animal or of an animal which has died
otherwise than by slaughter; or (6) if its con-
tainer is composed, in whole or in part, of any
poisonous or deleterious substance which may
render the contents injurious to health.
The amendment was agreed to.
The next amendment was, in the
same section, paragraph (b), on page
21, line 1, after the word "strength",
to strike out "to" and insert "or", so
as to make the paragraph read:
(b) (1) If any valuable constituent has been
in whole or in part abstracted therefrom; or
(2) if any substance has been substituted wholly
or in part therefor; or (3) if damage or in-
feriority has been concealed in any manner;
or (4) if any substance has been added thereto
or mixed or packed therewith so as to increase
its bulk or weight, or reduce its quality or
strength, or make it appear better or of greater
value than it is.
The amendment was agreed to.
[p.2009]
l.lOa (4) (b) VOL. 83 (1938), June 1: Amended and passed
House, pp. 7903
[No Relevant Discussion on Pertinent Section]
-------
924 LEGAL COMPILATION—PESTICIDES
l.lOa (4) (c) VOL. 83 (1938), June 10: Senate agrees to con-
ference report, p. 8733
"ADULTERATED FOOD
"SEC. 402. A food shall be deemed to be adulterated—
"(a) (1) If it bears or contains any poisonous or deleterious substance
which may render it injurious to health; but in case the substance is not an
added substance such food shall not be considered adulterated under this clause
if the quantity of such substance in such food does not ordinarily render it
injurious to health; or (2) if it bears or contains any added poisonous or add-
ed deleterious substance which is unsafe within the meaning of section 406; or
(3) if it consists in whole or in part of any filthy, putrid, or decomposed
substance, or if it is otherwise unfit for food; or (4) if it has been prepared,
packed, or held under insanitary conditions whereby it may have become con-
taminated with filth, or whereby it may have been rendered injurious to health;
or (5) if it is, in whole or in part, the product of a diseased animal or of an
animal which has died otherwise than by slaughter; or (6) if its container is
composed, in whole or in part, of any poisonous or deleterious substance which
may render the contents injurious to health.
"(b) (1) If any valuable constituent has been in whole or in part omitted
or abstracted therefrom; or (2) if any substance has been substituted wholly
or in part therefor; or (3) if damage or inferiority has been concealed in any
manner; or (4) if any substance has been added thereto or mixed or packed
therewith so as to increase its bulk or weight, or reduce its quality or strength,
or make it appear better or of greater value than it is.
" (c) If it bears or contains a coal-tar color other than one from a batch that
has been certified in accordance with regulations as provided by section 406:
Provided, That this paragraph shall not apply to citrus fruit bearing or con-
taining a coal-tar color if application for listing of such color has been made
under this Act and such application has not been acted on by the Secretary, if
such color was commonly used prior to the enactment of this Act for the
purpose of coloring citrus fruit.
"(d) If it is confectionery, and, it bears or contains any alcohol or nonnu-
tritive article or substance except harmless coloring, harmless flavoring, harm-
less resinous glaze not in excess of $io of 1 per centum, natural gum, and
pectin: Provided, That this paragraph shall not apply to any confectionery by
reason of its containing less than one-half of 1 per centum by volume of alco-
hol derived solely from the use of flavoring extracts, or to any chewing gum by
reason of its containing harmless nonnutritive masticatory substances.
[p. 8733]
l.lOa (4) (d) VOL. 83 (1938), June 13: House agrees to conference
report, pp. 9089-9090
[No Relevant Discussion on Pertinent Section]
l.lOb FEDERAL ADULTERATED FOOD AMENDMENTS
July 22,1954, P.L. 83-518, §2, 68 Stat. 511
SEC. 2. Clause (2) of section 402 (a) of the Federal Food, Drug,
and Cosmetic Act is amended to read as follows: " (2) if it bears
or contains any added poisonous or added deleterious substance,
except a pesticide chemical in or on a raw agricultural commodity,
-------
STATUTES AND LEGISLATIVE HISTORY 925
which is unsafe within the meaning of section 406, or if it is a
raw agricultural commodity and it bears or contains a pesticide
chemical which is unsafe within the meaning of section 408 (a);".
[p. 511]
l.lOb (1) HOUSE COMMITTEE ON INTERSTATE AND
FOREIGN COMMERCE
H.R. REP. No. 1385, 83rd Cong., 2d Sess. (1954)
AMENDING THE FEDERAL FOOD, DRUG, AND COSMETIC
ACT WITH RESPECT TO RESIDUES OF PESTICIDE
CHEMICALS IN OR ON RAW AGRICULTURAL
COMMODITIES
MARCH 23,1954.—Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
Mr. SPRINGER, from the U. S. Congress House Committee on
Interstate and Foreign Commerce, submitted the following
REPORT
[To accompany H.R. 7125]
The Committee on Interstate and Foreign Commerce, to whom
was referred the bill (H.R. 7125) to amend the Federal Food,
Drug, and Cosmetic Act with respect to residues of pesticide chemi-
cals in or on raw agricultural commodities, having considered the
same, report favorably thereon with amendments and recommend
that the bill as amended do pass.
The amendments are as follows:
Page 4, line 10, strike out "(1)" and insert "(1)".
Page 5, line 8, after "from", insert "the requirement of".
Page 6, line 7, strike out" (1)" and insert" (1)".
Page 6, line 9, after "Secretary", insert "of Health, Education,
and Welfare."
Page 6, line 20, strike out "event" and insert "events".
Page 6, line 25, strike out " (1)" and insert" (1)".
Page 7, line 2, after "or", insert "in the event"; and, in lines
3 and 4, after "Secretary", insert "of Health, Education, and
Welfare".
Page 10, line 1, strike out "person," and insert "person".
Page 11, line 3, strike out "or" and insert "of".
Page 12, line 20, strike out" (1)" and insert" (1)".
Page 13, line 17, strike out" (1)" and insert" (1)".
All of the foregoing amendments are either clerical or for the
purpose of making minor clarifications.
-------
926 LEGAL COMPILATION—PESTICIDES
PURPOSE
The primary purpose of the bill is to assure greater protection
of the public health by improving, simplifying, and speeding up the
[p.l]
method for regulating, under the provisions of the Federal Food,
Drug, and Cosmetic Act, the amount of residue which may remain
on raw agricultural commodities after use of pesticide chemicals.
Pesticide chemicals are substances such as insecticides, fungicides,
and weedkillers used in the production, storage, and transporta-
tion of food for the purpose of controlling insects, plant diseases,
weeds, and other pests. This bill is an exercise of the power of
Congress over the regulation of interstate commerce in adulter-
ated food.
This bill would accomplish its purpose primarily by adding to
the Federal Food, Drug, and Cosmetic Act an improved procedure
for establishment of tolerances for pesticide chemicals remaining
in or on raw agricultural commodities. Poisonous or deleterious
substances intentionally added to, or which remain in, other food
are subject to existing law and would not be affected by this bill.
A primary objective in drafting the bill was to develop legisla-
tion that would provide for prompt administrative action to permit
effective use of pesticide chemicals without hazard to the public
health; legislation that would be safe for consumers and practical
for producers.
The committee knows of no opposition to the bill. All interested
parties are agreed as to the need for the bill.
Existing law
Under existing law, added poisonous and deleterious sub-
stances—and most pesticide chemicals fall in this class—must be
kept out of foods unless they are required in production or cannot
be avoided by good manufacturing practice. When such a sub-
stance is required in production—as many pesticide chemicals are
required in growing agricultural crops—a tolerance may be estab-
lished by the Secretary of Health, Education, and Welfare, but
only after a formal public hearing. (The maximum amount of resi-
due that may lawfully remain in or on the food is commonly
referred to as a tolerance.) Detailed findings of fact and conclu-
sions must be made by the Secretary as to the required use of the
pesticide and the residue levels that may safely be tolerated.
Need for new legislation
Regulations limiting the amount of pesticidal residue which may
remain in or on food have been issued under the present law in
-------
STATUTES AND LEGISLATIVE HISTORY 927
only one instance, although the law authorizing such regulations
has been in effect for over 15 years. During all that time control
has been exercised through unofficial and informal tolerances. In
1950, lengthy public hearings were held for the purpose of estab-
lishing official tolerances (the maximum amount of poisonous or
deleterious residue which may legally remain in or on food) for
fresh fruits and vegetables. These hearings, at a cost of nearly a
half-million dollars to Government, to industry, to agricultural
organizations, and to the various land-grant colleges, produced
a very large volume of evidence that had not theretofore been
gathered together, but the record is still under consideration by
the Government and the necessary tolerances have not yet been
issued. This has been responsible for uncertainty under the law.
It has handicapped the Government in enforcing the law, the
grower in complying with the law, and the pesticide manufacturer
and Federal and State agencies in discharging their responsibility
for advising and making recommendations to the grower with
[p. 2]
respect to the use of pesticide chemicals. This, together with the
introduction of a large number of new pesticide chemicals, some of
which are known to be toxic, has been responsible for concern
that existing law is inadequate to protect the public health.
It has been generally recognized that a primary reason why tol-
erances have not been established to control agricultural usage of
pesticide chemicals as intended by Congress has been the cumber-
some, time-consuming, and impracticable procedure prescribed by
existing law.
SUMMARY OF THE BILL
Under this bill, a regulation establishing a tolerance for a pesti-
cide chemical used on raw agricultural commodities may be initi-
ated by an applicant for registration of an economic poison under
the Federal Insecticide, Fungicide, and Rodenticide Act or by the
Secretary of Health, Education, and Welfare. It is anticipated that,
in the usual case, registration of a new economic poison would be
withheld by the Department of Agriculture pending the issuance
of the tolerance.
The tolerance-setting process for a particular pesticide chemical
started by a person other than the Secretary is accomplished by (a)
filing with the Secretary of Agriculture a request to certify to the
Secretary of Health, Education, and Welfare that the pesticide
chemical is useful for its intended purpose and that the requested
tolerance reflects the amount of residue, if any, likely to result when
the pesticide is used as proposed; and (b) filing of a petition
-------
928 LEGAL COMPILATION—PESTICIDES
proposing the tolerance, together with supporting scientific data to
establish safe residue levels, with the Secretary of Health, Educa-
tion, and Welfare. Within 90 days after the Secretary of Agricul-
ture has certified to usefulness, the Secretary of Health, Education,
and Welfare would make public a regulation establishing the
tolerance.
The basic authority, under the bill, to establish tolerances or
exemptions from tolerances directs the Secretary of Health, Educa-
tion, and Welfare to limit in or on raw agricultural commodities
residues of poisonous or deleterious pesticide chemicals and pesti-
cide chemicals of unknown or uncertain toxicity "to the extent
necessary to protect the public health." In doing so, the Secretary
is directed to take into account the necessity for the production of
an adequate, wholesome, and economical food supply and the
Secretary of Agriculture's opinion as to the amount of residue that
will remain, as well as the overall effect the pesticide chemical may
have in consumers' diets.
The Secretary is authorized to fix the tolerance at zero—and thus
prohibit any residue—when the scientific data submitted does not
justify a greater tolerance.
Provision is made for the referral of a petition proposing a toler-
ance or exemption to an ad hoc advisory committee of scientific
experts selected by the National Academy of Sciences for a report
and recommendation where this is requested by the proponent of
the tolerance or is otherwise deemed necessary by the Secretary of
Health, Education, and Welfare. Such referral extends the time
limits otherwise prescribed for administrative action. The report
and recommendation of any such advisory committee is considered
by the Secretary before a tolerance is established and may be made
a part of the official record in the event of a public hearing, in
accordance with the provisions of the Administrative Procedure
Act.
[p. 3]
Section 2
The Federal Food, Drug, and Cosmetic Act (in sec. 301 (a)) pro-
hibits the shipment in interstate commerce of adulterated food.
Under section 402 (a) (2), a food is deemed to be adulterated if
it bears or contains any "added" poisonous or deleterious substance
which is "unsafe" within the meaning of section 406 of the act.
Section 406 contains a general declaration that any poisonous or
deleterious substance added to food is unsafe except where the sub-
stance is "required in the production thereof and cannot be avoided
by good manufacturing practice." However, in any case where such
-------
STATUTES AND LEGISLATIVE HISTORY 929
a substance is so required or cannot be so avoided (and this is so in
case of the use of pesticide chemicals in the production of most raw
agricultural commodities), section 406 directs the Secretary of
Health, Education, and Welfare to promulgate regulations limiting
the quantity on the food to such extent as such Secretary finds to be
necessary for protection of the public health.
As explained elsewhere in this report, the primary purpose of
this legislation is to provide a new method, and new procedures, for
regulating the amount of pesticide chemical residue which shall be
permitted to remain in or on raw agricultural commodities.
To attain this objective, section 2 of the bill amends section 402
(a) (2) so as to provide, in the case of any raw agricultural com-
modity bearing or containing a pesticide chemical, that such
commodity shall be deemed to be adulterated if such pesticide
chemical is unsafe within the meaning of the new section 408 (a)
which is being added to the law by section 3 of the bill. Thus,
section 406 of the law will no longer be applicable in the case of
raw agricultural commodities bearing or containing pesticide
chemicals.
[p. 7]
l.lOb (2) SENATE COMMITTEE ON LABOR AND PUBLIC
WELFARE
S. REP. No. 1635, 83rd Cong., 2d Sess. (1954)
AMENDING THE FEDERAL FOOD, DRUG, AND COSMETIC
ACT WITH RESPECT TO RESIDUES OF PESTICIDE CHEM-
ICALS IN OR ON RAW AGRICULTURAL COMMODITIES
JUNE 25 (legislative day, JUNE 22), 1954.—Ordered to be printed
Mr. PURTELL, from the Committee on Labor and Public Welfare,
submitted the following
REPORT
[To accompany H.R. 7125]
The Committee on Labor and Public Welfare, to whom was
•eferred the bill (H.R. 7125) to amend the Federal Food, Drug,
md Cosmetic Act with respect to residues of pesticide chemicals in
)r on raw agricultural commodities, having considered the same,
•eport favorably thereon with an amendment and recommend that
;he bill as amended do pass.
-------
930 LEGAL COMPILATION—PESTICIDES
The amendment is as follows:
On page 18, line 20, immediately preceding section 4, add a new
subsection (o) as follows:
(o) The Secretary of Health, Education, and Welfare shall by regulation
require the payment of such fees as will in the aggregate, in the judgment of
•die Secretary, be sufficient over a reasonable term to provide, equip, and main-
tain an adequate service for the performance of the Secretary's functions
under this section. Under such regulations, the performance of the Secretary's
services or other functions pursuant to this section, including any one or more
of the following, may be conditioned upon the payment of such fees: (1) the
acceptance of filing of a petition submitted under subsection (d); (2) the
promulgation of a regulation establishing a tolerance, or an exemption from
the necessity of a tolerance, under this section, or the amendment or repeal of
such a regulation; (3) the referral of a petition or proposal under this section
to an advisory committee; (4) the acceptance for filing of objections under
subsection (d) (5); or (5) the certification and filing in court of a transcript
of the proceedings and the record under subsection (i) (2). Such regulations
may further provide for waiver or refund of fees in whole or in part when in
the judgment of the Secretary such waiver or refund is equitable and not
contrary to the purposes of this subsection.
PURPOSE OF THE BILL
The primary purpose of the bill is to assure greater protection of
the public health by improving, simplifying, and speeding up the
procedure under the Federal Food, Drug, and Cosmetic Act, for
[p. 1]
regulating the amount of residue which may remain on raw agri-
cultural commodities after use of pesticide chemicals.
Pesticide chemicals are substances such as insecticides, fungi-
cides, and weedkillers used in the production, storage, and trans-
portation of food for the purpose of controlling insects, plant
diseases, weeds, and other pests.
A primary objective in drafting the bill was to develop legisla-
tion that would provide for prompt administrative action to permit
effective use of pesticide chemicals without hazard to the public
health; legislation that would be safe for consumers and practical
for producers.
The committee knows of no opposition to the bill. All interested
parties are agreed as to the need for the bill.
Existing law
Under existing law, added poisonous and deleterious substances
—and most pesticide chemicals fall in this class—must be kept out
of foods unless they are required in production or cannot be avoid-
ed by good manufacturing practice. When such a substance is
required in production—as many pesticide chemicals are required
-------
STATUTES AND LEGISLATIVE HISTORY 931
in growing agricultural crops—a tolerance may be established by
the Secretary of Health, Education, andWelfare, but only after a
formal public hearing. Detailed findings of fact and conclusions
must be made by the Secretary as to the required use of the pesti-
cide and the residue levels that may safely be tolerated.
Need for new legislation
Regulations limiting the amount of pesticidal residue which may
remain in or on food have been issued under the present law in only
one instance, although the law authorizing such regulations has
been in effect for over 15 years. During all that time control has
been exercised through unofficial and informal tolerances. In 1950,
lengthy public hearings were held for the purpose of establishing
official tolerances for fresh fruits and vegetables. These hearings,
at a cost of nearly a half-million dollars to Government, to industry,
to agricultural organizations, and to the various land-grant col-
leges, produced a very large volume of evidence that had not
theretofore been gathered together, but the record is still under
consideration by the Government and the necessary tolerances
have not yet been issued. This has been responsible for uncertainty
under the law. It has handicapped the Government in enforcing
the law, the grower in complying with the law, and the pesticide
manufacturer and Federal and State agencies in discharging their
responsibility for advising and making recommendations to the
grower with respect to the use of pesticide chemicals. This, together
with the introduction of a large number of new pesticide chemicals,
some of which are known to be toxic, has been responsible for
concern that existing law is inadequate to protect the public health.
It has been generally recognized that a primary reason why
tolerances have not been established to control agricultural usage
of pesticide chemicals as intended by Congress has been the cum-
bersome, time-consuming, and impracticable procedure prescribed
by existing law.
[p. 2]
ANALYSIS OF THE BILL BY SECTIONS
An explanation of the various provisions of the bill is contained
in the sectional analysis which follows:
*******
Section 2
The Federal Food, Drug, and Cosmetic Act (in sec. 301 (a) )
prohibits the shipment in interstate commerce of adulterated food.
Under section 402 (a) (2), a food is deemed to be adulterated if
it bears or contains any "added" poisonous or deleterious substance
-------
932
LEGAL COMPILATION—PESTICIDES
which is "unsafe" within the meaning of section 406 of the act.
[p. 6]
Section 406 contains a general declaration that any poisonous or
deleterious substance added to food is unsafe except where the sub-
stance is "required in the production thereof and cannot be avoided
by good manufacturing practice." However, in any case where such
a substance is so required or cannot be so avoided (and this is so in
case of the use of pesticide chemicals in the production of most raw
agricultural commodities), section 406 directs the Secretary of
Health, Education, and Welfare to promulgate regulations limiting
the quantity on the food to such extent as such Secretary finds to
be necessary for protection of the public health.
As explained elsewhere in this report, the primary purpose of
this legislation is to provide a new method, and new procedures, for
regulating the amount of pesticide chemical residue which shall be
permitted to remain in or on raw agricultural commodities.
To attain this objective, section 2 of the bill amends section 402
(a) (2) so as to provide, in the case of any raw agricultural com-
modity bearing or containing a pesticide chemical, that such
commodity shall be deemed to be adulterated if such pesticide
chemical is unsafe within the meaning of the new section 408 (a),
which is being added to the law be section 3 of the bill. Thus,
section 406 of the law will no longer be applicable in the case of
raw agricultural commodities bearing or containing pesticide
chemicals.
[p. 7]
l.lOb (3) CONGRESSIONAL RECORD, VOL. 100 (1954)
l.lOb (3) (a) April 5: Amended and passed House, pp. 4604
[No Relevant Discussion on Pertinent Section]
l.lOb (3) (b) July 6: Amended and passed Senate, p. 9726
The PRESIDING OFFICER. Is
there objection to the present consider-
ation of the bill?
Mr. HOLLAND. Mr. President, I
think this is an excellent bill, but I
think the RECORD should contain the
showing, which I believe is a good
showing, contained in the committee
report on the bill, indicating the im-
provements over existing law. I ask
that that part of the report, including
all of page 4 and down through the
second paragraph on page 5, under the
heading "Improvements Over Existing
Law" be printed in the RECORD at this
point as a part of my remarks.
There being no objection, the ex-
cerpt was ordered to be printed in the
RECORD, as follows:
IMPROVEMENTS OVER EXISTING LAW
The principal respects in which this bill
would change and improve existing law are—
1. A specific method for controlling the resi-
due of pesticide chemicals which may remain
in or on raw agricultural commodities is set
up which is distinct from that controlling: other
poisonous or deleterious substances which are
used in, or remain in, processed, fabricated,
and manufactured food. In this way, recogni-
tion is given to the peculiar economic, agricul-
-------
STATUTES AND LEGISLATIVE HISTORY
933
tural, and public health problems which are
important in the regulation of pesticide chem-
icals. Unlike many other chemicals, pesticide
chemicals are necessary instruments of agri-
culture in producing and expanding our food
supply and are comprehensively regulated by
the Department of Agriculture under the Fed-
eral Insecticide, Fungicide, and Rodenticide Act.
2. The determination of questions of agri-
cultural usefulness and probable residue levels
involved in the establishment of tolerances, is
made a function of the Department of Agri-
culture; while the determination of questions
of a public health nature remains a function
of the Department of Health, Education, and
Welfare. In this way, a more logical grouping
of governmental functions is effected than un-
der existing law which casts the responsibility
for determining agricultural questions as well
as public health questions upon the Department
of Health, Education, and Welfare.
3. Before any pesticide-chemical residue may
remain in or on a raw agricultural commodity,
scientific data must be presented to show that
the pesticide-chemical residue is safe from the
standpoint of the food consumer. The burden
is on the person proposing the tolerance or
exemption to establish the safety of such pesti-
cide-chemical residue.
4. Specific time limits for informal admin-
istrative action in establishing tolerances are
prescribed to avoid the adverse consequences of
inaction and protracted delay. Promptness is
vital in this area of regulation to all concerned.
5. Provision is made for the appointment of
independent committees of scientific experts
selected by the National Academy of Sciences
to study proposed regulations establishing toler-
ances for pesticide chemicals and to make rec-
ommendations thereon to the Department of
Health, Education, and Welfare.
6. The procedure prescribed for establishing
tolerances emphasizes informal proceedings
rather than the formal public hearing type of
proceedings. This is accomplished in two ways:
First, the bill sets up a procedure whereby the
manufacturer or formulator most directly con-
cerned with the establishment of a tolerance
for a particular pesticide chemical has the right
to initiate the proceedings for a tolerance on
that chemical by filing a petition. Second, the
bill provides for the initial setting of toler-
ances without a formal public hearing, limit-
ing such hearings to issues which may remain
in dispute at the conclusion of the informal
proceedings. Existing law requires a formal
public hearing before any tolerance can be
established and such a proceeding can be ini-
tiated only upon the request of a substantial
segment of the industry or upon the initiative
of the Government.
7. Where the informal procedures do not pro-
duce a satisfactory tolerance or exemption the
rights of all concerned to a full and fair hear-
ing on the disputed issues are preserved.
8. Enforcement of the adulteration provi-
sions relating to raw agricultural commodities
bearing pesticide chemicals is simplified and
made moi e effective, since, undei the bill,
authoiity to establish tolerances extends to pes-
ticide chemicals not generally recognized among
experts qualified by scientific training and expe-
rience to evaluate the safety of pesticide chem-
icals, as safe for use, as well as pesticide chem-
icals which are known to be poisonous or dele-
terious.
9. Provision is made for the exemption of
pesticide chemicals from the requirements of
a tolerance in cases where tolerances are not
necessary to protect the public health and for
the establishment of temporary tolerances for
those pesticide chemicals which are used in or
on raw agricultural commodities under experi-
mental permits issued by the Department of
Agriculture.
Mr. HENDRICKSON. Mr. Presi-
dent, I thank the distinguished Senator
from Connecticut for his able and en-
lightening explanation. I think he has
made a fine record for the bill.
The PRESIDING OFFICER. Is
there objection to the present consider-
ation of the bill?
There being no objection, the Senate
proceeded to consider the bill, which
had been reported from the Committee
on Labor and Public Welfare with an
[p.9726]
amendment, on page 18, after line 19,
to insert:
(o) The Secretary of Health, Education, and
Welfare shall by regulation require the payment
of such fees as will in the aggregate, in the
judgment of the Secretary, be sufficient over a
reasonable term to provide, equip, and maintain
an adequate service for the performance of the
Secretaiy's functions under this section. Under
such regulations, the performance of the Secre-
taiy's sei vices or other functions pursuant to
this section, including any one or more of the
following, may be conditioned upon the payment
of such fees: (1) The acceptance of filing of a
petition submitted under subsection (d); (2) the
promulgation of a regulation establishing a tol-
erance, or an exemption from the necessity of
a tolerance, under this section, or the amend-
ment or repeal of such a regulation; (3) the
referral of a petition or proposal under this
section to an advisory committee; (4) the
acceptance for filing: of objections under sub-
section (d) (B); or (5) the certification and
filing: in court of a transcript of the proceedings
and the record under subsection (i) (2). Such
regulations may further provide for waiver or
-------
934
LEGAL COMPILATION—PESTICIDES
refund of fees in whole or in part when in the
judgment of the Secretary such waiver or re-
fund is equitable and not contrary to the pur-
poses of this subsection.
The amendment was agreed to.
The amendment was ordered to be
engrossed and the bill to be read a
third time.
The bill was read the third time and
passed.
[p. 9727]
l.lOb (3) (c) July 8: House concurs in Senate amendment,
p. 10095
[No Relevant Discussion on Pertinent Section]
l.lOc FOOD ADDITIVES AMENDMENT OF 1958
September 6,1958, P.L. 85-929, §3(a), (b), 72 Stat. 1784
SEC. 3. (a) Clause (2) of section 402 (a), as amended, of such
Act is amended to read as follows: " (2) (A) if it bears or contains
any added poisonous or added deleterious substance (except a
pesticide chemical in or on a raw agricultural commodity and
except a food additive) which is unsafe within the meaning of
section 406, or (B) if it is a raw agricultural commodity and it
bears or contains a pesticide chemical which is unsafe within the
meaning of section 408 (a), or (C) if it is, or it bears or contains,
any food additive which is unsafe within the meaning of section
409: Provided, That where a pesticide chemical has been used in or
on a raw agricultural commodity in conformity with an exemption
granted or a tolerance prescribed under section 408 and such raw
agricultural commodity has been subjected to processing such as
canning, cooking, freezing, dehydrating, or milling, the residue of
such pesticide chemical remaining in or on such processed food
shall, notwithstanding the provisions of sections 406 and 409, not
be deemed unsafe if such residue in or on the raw agricultural
commodity has been removed to the extent possible in good manu-
facturing practice and the concentration of such residue in the
processed food when ready to eat is not greater than the tolerance
prescribed for the raw agricultural commodity;".
[p.1784]
(b) Section 402 (a), as amended, of such Act is further amend-
ed by striking out the period at the end thereof and inserting in
lieu thereof a semicolon and the following: "or (7) if it has been
intentionally subjected to radiation, unless the use of the radiation
was in conformity with a regulation or exemption in effect pursu-
ant to section 409."
[p.1785]
-------
STATUTES AND LEGISLATIVE HISTORY 935
l.lOc (1) HOUSE COMMITTEE ON INTERSTATE AND
FOREIGN COMMERCE
H.R. REP. No. 2284, 85th Cong., 2d Sess. (1958)
FOOD ADDITIVES AMENDMENT OF 1958
JULY 28,1958.—Committed to -he 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. 13254]
The Committee on Interstate and Foreign Commerce, to whom
was referred the bill (H.R. 13254) to protect the public health by
amending the Federal Food, Drug, and Cosmetic Act to prohibit the
use in food of additives which have not been adequately tested to
establish their safety, 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 all of the text of the introduced bill and
inserts in lieu thereof a substitute which appears in the reported
bill in italic type.
PURPOSE OP LEGISLATION
The purpose of the legislation is twofold:
(1) To protect the health of consumers by requiring manufac-
turers of food additives and food processors to pretest any poten-
tially unsafe substances which are to be added to food; and (2) to
advance food technology by permitting the use of food additives
at safe levels.
Existing law bars the use, even at safe levels, of additives which
are poisonous or deleterious unless their use is required in produc-
tion or cannot be avoided by good manufacturing practice. The
Federal Government in order to prevent the use of an additive
must prove that it is a poisonous or deleterious substance. The law
thus gives rise to a dual problem. On the one hand, to prove an
untested substance poisonous or deleterious may require approxi-
mately 2 years or more of laboratory experiments with small ani-
mals and during this period the Government cannot prevent the
use of such a substance in food. On the other hand, present law
[p.l]
-------
936 LEGAL COMPILATION—PESTICIDES
entirely prohibits the use of these additives even if their use at
safe levels would advance our food technology and increase and
improve our food supplies.
The Food and Drug Administration has pointed out the dangers
to the public health resulting from the failure of the present law to
require pretesting of food additives. On the other hand that agency
agrees that the present law should be changed to permit the use of
additives at safe levels in order to advance our food technology.
While the responsible elements of the affected industries tradi-
tionally have voluntarily undertaken to pretest food additives they
are willing to assume this responsibility under a statutory mandate.
Thus, those elements of the industry which in the past have used
harmful additives or additives of unknown toxicity without pre-
testing will in the future under this legislation be required to
assume the same duties as the responsible elements have heretofore
voluntarily assumed.
Although there has been complete agreement as to the need for
this legislation, there have been differences between the Food and
Drug Administration and the affected industries with respect to
procedures to be followed in determining the safety of an additive
and the method of judicial review of such a determination. With
respect to these controversial procedural questions, the committee
feels the proposed legislation steers a course which satisfies both
the need for protecting the public health and the legitimate inter-
ests of industry and Government in fair procedures.
HISTORY OF LEGISLATION
During the 81st Congress, a Select Committee To Investigate the
Use of Chemicals in Foods and Cosmetics (better known as the
Delaney committee, named after its chairman, Congressman James
J. Delaney) was created in the House of Representatives to study
the need to amend the present Federal Food, Drug, and Cosmetic
Act in this respect. After extended hearings, the committee on
June 30, 1952, filed a report (H. Kept. No. 2356, 82d Cong., 2d
sess.) urging amending the present law so that chemicals employed
in or on foods would be subjected to substantially the same safety
requirements as exist in the law for new drugs.
Bills to accomplish the objectives of the report were introduced
by Congressman Delaney and referred to this committee during the
83d Congress and subsequent Congresses, and other Members of
Congress introduced numerous bills differing from the prototype
bills primarily with respect to agency procedure and judicial
review.
-------
STATUTES AND LEGISLATIVE HISTORY 937
During the 83d Congress, the committee held hearings and
reported favorably related legislation providing for the pretesting
of, and the establishment of safe tolerances for, pesticide chemicals.
This bill was enacted into law (Public Law 518, 83d Cong.).
During the 2d session of the 84th Congress, the Subcommittee on
Health and Science, under the chairmanship of the late full com-
mittee chairman, J. Percy Priest, held 5 days of hearings on 10
bills dealing with chemical additives in and on food. The hearings
indicated basic agreement with regard to the need for chemical
additive legislation, but also considerable disagreement with regard
to the agency and judicial review procedures to be followed in
determining the safety of chemical additives. This disagreement
was not resolved, and no chemical additive legislation was enacted
during the 84th Congress.
[p. 2]
ADULTERATED FOOD
SEC. 402. A food shall be deemed to be adulterated—
(a) (1) If it bears or contains any poisonous or deleterious
substance which may render it injurious to health; but in case the
substance is not an added substance such food shall not be consid-
ered adulterated under this clause if the quantity of such substance
in such food does not ordinarily render it injurious to health; or
(2) (A) if it bears or contains any added poisonous or added dele-
terious substance, [except] (except a pesticide chemical in or on a
raw agricultural [commodity,] commodity and except food addi-
tive) which is unsafe within the meaning of section 406, or (B) if
it is a raw agricultural commodity and it bears or contains a pesti-
cide chemical which is unsafe within the meaning of section [408
(a) ] 408 (a), or (C) if it is, or it bears or contains, any food
additive which is unsafe within the meaning of section 409:
Provided, That where a pesticide chemical has been used in or on a
raw agricultural commodity in conformity with an exemption
granted or a tolerance prescribed under section 408 and such raw
agricultural commodity has been subjected to processing by cook-
ing, freezing, dehydrating, or milling, the residue of such pesticide
chemical remaining in or on such processed food shall, notwith-
standing the provisions of section 406 and 409, not be deemed
unsafe if such residue in or on the raw agricultural commodity
has been removed to the extent possible in good manufacturing
practice and the concentration of such residue 'in the processed
food when ready to eat is not greater than the tolerance prescribed
for the raw agricultural commodity; or (3) if it consists in whole
or in part of any filthy, putrid, or decomposed substance, or if it is
-------
938 LEGAL COMPILATION—PESTICIDES
otherwise unfit for food; or (4) if it has been prepared, packed, or
held under insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been rendered
injurious to health; or (5) if it is, in whole or in part, the product
of a diseased animal or of an animal which has died otherwise than
by slaughter; or (6) if its container is composed, in whole or in
part, of any poisonous or deleterious substance which may render
the contents injurious to health; or (7) if it has been intentionally
subjected to ionizing radiation, unless the use of the ionizing radia-
tion was in conformity with a regulation or exemption in effect
pursuant to section 409.
(b) (1) If any valuable constitutent has been in whole or in part
omitted or abstracted therefrom; or (2) if any substance has been
substituted wholly or in part therefor; or (3) if damage or inferi-
ority has been concealed in any manner; or (4) if any substance
has been added thereto or mixed or packed therewith so as to
increase its bulk or weight, or reduce its quality or strength, or
make it appear better or of greater value than it is.
[p. 12]
l.lOc (2) SENATE COMMITTEE ON LABOR AND PUBLIC
WELFARE
S. REP. No. 2422, 85th Cong., 2d Sess. (1958)
FOOD ADDITIVES AMENDMENT OF 1958
AUGUST 18 (legislative day, AUGUST 16), 1958.—Ordered to be printed
Mr. HILL, from the Committee on Labor and Public Welfare,
submitted the following
REPORT
[To accompany H. R. 13254]
The Committee on Labor and Public Welfare, to whom was
referred the bill (H. R. 13254) to protect the public welfare by
amending the Federal Food, Drug, and Cosmetic Act to prohibit
the use in food of additives which have not been adequately tested
to establish their safety, having considered the same, report favor-
ably thereon, with amendments, and recommend that the bill do
pass.
EXPLANATION
The two amendments which this committee has added to the
bill as passed by the House, which are discussed in detail below,
-------
STATUTES AND LEGISLATIVE HISTORY 939
do not in any way change the substance or content of the bill
which passed the House of Representatives without dissent. They
deal, not with the content of that bill, but with related problems
regarding the ability of the Department of Health, Education,
and Welfare to secure and retain the services of individuals
unquestionably qualified to protect and to better the health of our
people.
In explanation of the bill sent us by the House, passage of which
your committee recommends with additions but without change
in any of its provisions, we would point out first that under exist-
ing law the Federal Government is unable to prevent the use in
foods of a poisonous or deleterious substance until it first proves
that the additive is poisonous or deleterious. To establish this
proof through experimentation with generations of mice or other
animals may require 2 years or even more on the part of the rela-
tively few scientists the Food and Drug Administration is able
to assign to a particular problem. Yet, until that proof is forth-
coming, an unscrupulous processor of foodstuffs is perfectly free
to purvey to millions of our people foodstuffs containing additives
which may or may not be capable of producing illness, debility,
or death. r ,,
[P-1]
PRINCIPAL PROVISIONS OF LEGISLATION
Substances covered by legislation
Pretesting is required under this legislation only with respect
to those food additives which are not generally recognized among
competent experts as having been adequately shown to be safe
under the conditions of their intended use. An additive may be
shown to be safe either by means of scientific procedures (includ-
[p-4]
ing a review of the existing scientific literature) or, in the case
of substances in use prior to January 1, 1958, also by means of
experience based on common use in food.
The legislation covers substances which are added intentionally
to food. These additives are generally referred to as "intentional
additives."
The legislation also covers substances which may reasonably
be expected to become a component of any food or to affect the
characteristics of any food. These substances are generally refer-
red to as "incidental additives."
The principal examples of both intentional and incidental addi-
tives are substances intended for use in producing, manufactur-
ing, packing, processing, preparing, treating, packaging, trans-
porting, or holding food.
-------
940 LEGAL COMPILATION—PESTICIDES
On the other hand, substances which may accidentally get into a
food, as for example, paints or cleaning solutions used in food
processing plants, are not covered by the legislation. These addi-
tives are generally referred to as "accidental additives," since
these substances if properly used may not reasonably be expected
to become a component of a food or otherwise to affect the char-
acteristics of a food. If accidental additives do get into food, the
provisions of the Food, Drug, and Cosmetic Act dealing with poi-
sonous and deleterious substances would be applicable.
Sources of radiation (including radioactive isotopes, particle
accelerators and X-ray machines) intended for use in processing
food are included in the term "food additive" as defined in this
legislation.
Exempted from the scope of the legislation are (1) pesticide
chemicals in or on raw agricultural commodities which are already
covered by the pesticide chemicals amendment to the Federal
Food, Drug, and Cosmetic Act (Public Law 518, 83d Cong.) ; (2)
residues of pesticide chemicals unavoidably remaining on pro-
cessed foods not in excess of tolerances prescribed by Food and
Drug Administration for raw agricultural commodities; and (3)
substances already approved under the provisions of the Federal
Food, Drug, and Cosmetic Act or the Meat Inspection Act of
March 4,1907.
The Secretary is given authority by this legislation to exempt
by regulation food additives for investigational use by qualified
experts when consistent with the public health.
CHAPTER IV—FOOD Cp- 5]
*******
ADULTERATED FOOD
SEC. 402. A food shall be deemed to be adulterated—
(a) (1) If it bears or contains any poisonous or deleterious
substance which may render it injurious to health; but in case the
substance is not an added substance such food shall not be con-
sidered adulterated under this clause if the quantity of such sub-
stance in such food does not ordinarily render it injurious to
health; or (2) (A) if it bears or contains any added poisonous or
added deleterious substance, [except] (except a pesticide chemi-
cal in or on a raw agricultural [commodity,] commodity and
except a food additive) which is unsafe within the meaning of
section 406, or (B) if it is a raw agricultural commodity and it bears
or contains a pesticide chemical which is unsafe within the mean-
ing of section [408 (a) ] 408 (a), or (C) if it is, or it bears or con-
-------
STATUTES AND LEGISLATIVE HISTORY 941
tains, any food additive which is unsafe within the meaning of
section 409: Provided, That where a pesticide chemical has been
used in or on a raw agricultural commodity in conformity with
an exemption granted or a tolerance prescribed under section 408
and such raw agricultural commodity has been subjected to proc-
essing such as canning, cooking, freezing, dehydrating, or milling,
the residue of such pesticide chemical remaining in or on such
processed food shall, notwithstanding the provisions of sections
406 and 409, not be deemed unsafe if such residue in or on the
raw agricultural commodity has been removed to the extent pos-
sible in good manufacturing practice and the concentration of
such residue in the processed food when ready to eat is not greater
than the tolerance prescribed for the raw agicultural commodity;
or (3) if it consists in whole or in part of any filthy, putrid, or
decomposed substance, or if it is otherwise unfit for food; or (4)
if it has been prepared, packed, or held under insanitary condi-
tions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health; or (5)
if it is, in whole or in part, the product of a diseased animal or of
an animal which has died otherwise than by slaughter; or (6) if
its container is composed, in whole or in part, of any poisonous
or deleterious substance which may render the contents injurious
to health; or (7) if it has been intentionally subjected to radio.-
[p. 14]
tion, unless the use of the radiation icas in conformity with a
regulation or exemption in effect pursuant to section 409.
*******
[p. 15]
l.lOc (3) CONGRESSIONAL RECORD, VOL. 104 (1958)
l.lOc (3) (a) Aug. 13: Amended and passed House, pp. 17412,
17414-17415,17418,17422-17424
AMENDING FEDERAL FOOD,
DRUG AND COSMETIC ACT—USE
OF ADDITIVES IN FOOD
Mr. HARRIS. Mr. Speaker, I move
to suspend the rules and pass the bill
(H. R. 13254) to protect the public
health by amending the Federal Food,
Drug, and Cosmetic Act to prohibit the
use in food of additives which have not
been adequately tested to establish
Be it enacted, etc.. That this act may be cited
as the "Food Additives Amendment of 1958."
SEC. 3 (a) Clause (2) of section 402 (a), as
amended, or such act is amended to read as
follows: "(2) (A) if it bears or contains any
added poisonous or added deleterious substance
(except a pesticide chemical in or on a raw
agricultural commodity and except a food ad-
ditive) which U unsafe within the meaning of
section 406, or (B) if it is a raw agricultural
commodity and it bears or contains a pesticide
chemical which is unsafe within the meaning
of section 408 (a), or (C) if it is, or it bears or
contains, any food additive which is unsafe
their safety, as amended. . ,. ., . . . ,„„„.,,
within the meaning of section 409; Provided,
The Clerk read as follows: That where a pesticide chemicai ha3 been used
in or on a raw agricultural commodity in con-
formity with an exemption granted or a toler-
-------
942
LEGAL COMPILATION—PESTICIDES
ance prescribed under section 408 and such
raw agricultural commodity has been subjected
to processing such as canning, cooking, freez-
ing, dehydrating, or milling, the residue of such
pesticide chemical remaining in or on such
processed food shall, notwithstanding the pro-
visions of sections 406 and 409, not be deemed
unsafe if such residue in or on the raw agri-
cultural commodity has been removed to the
extent possible in good manufacturing practice
and the concentration of such residue in the
processed food when ready to eat is not greater
than the tolerance prescribed for the raw agri-
cultural commodity;".
(b) Section 402 (a), as amended, of such act
is further amended by striking out the period
at the end thereof and inserting in lieu thereof
a semicolon and the following: "or (7) if it
has been intentionally subjected to radiation,
unless the use of the radiation was in con-
formity with a regulation or exemption in effect
pursuant to section 409."
[p. 17412]
Mr. HARRIS.
The purpose of the legislation is
two-fold :
First, to protect the health of con-
sumers by requiring manufacturers of
food additives and food processors to
pretest any potentially unsafe sub-
stances which are to be added to food;
and second, to advance food technol-
ogy by permitting the use of food addi-
tives at safe levels.
Existing law bars the use, even at
safe levels, of additives which are
poisonous or deleterious unless their
use is required in production or cannot
be avoided by good manufacturing
practice. The Federal Government in
order to prevent the use of an additive
must prove that it is a poisonous or
deleterious substance. The law thus
gives rise to a dual problem. On the
one hand, to prove an untested sub-
stance poisonous or deleterious may
require approximately 2 years or more
of laboratory experiments with small
animals and during this period the
Government cannot prevent the use of
such a substance in food. On the other
hand, present law entirely prohibits
the use of these additives even if their
use at safe levels would advance our
food technology and increase and im-
prove our food supplies.
The Food and Drug Administration
has pointed out the dangers to the pub-
lic health resulting from the failure of
the present law to require pretesting
of food additives. On the other hand
that agency agrees that the present
law should be changed to permit the
use of additives at safe levels in order
to advance our food technology.
While the responsible elements of
the affected industries traditionally
have voluntarily undertaken to pretest
food additives they are willing to as-
sume this responsibility under a statu-
tory mandate. Thus, those elements of
the industry which in the past have
used harmful additives or additives of
unknown toxicity without pretesting
will in the future under this legislation
be required to assume the same duties
as the responsible elements have here-
tofore voluntarily assumed.
[p. 17413]
Although there has been complete
agreement as to the need for this legis-
lation, there have been differences be-
tween the Food and Drug Administra-
tion and the affected industries with
respect to procedures to be followed in
determining the safety of an additive
and the method of judicial review of
such a determination. With respect to
these controversial procedural ques-
tions, the committee feels the proposed
legislation steers a course which sat-
isfies both the need for protecting the
public health and the legitimate in-
terests of industry and Government in
fair procedures.
During the 81st Congress, a Select
Committee To Investigate the Use of
Chemicals in Foods and Cosmetics—
better known as the Delaney commit-
tee, named after its chairman, Con-
gressman JAMES J. DELANEY — was
created in the House of Representa-
tives to study the need to amend the
present Federal Food, Drug, and Cos-
metic Act in this respect. After ex-
tended hearings, the committee on June
-------
STATUTES AND LEGISLATIVE HISTORY
943
30, 1952, filed a report—House Report
No. 2356, 82nd Congress, 2d session-
urging amending the present law so
that chemicals employed in or on foods
would be subjected to substantially
the same safety requirements as exist
in the law for new drugs.
Bills to accomplish the objectives of
the report were introduced by Con-
gressman DELANEY and referred to
this committee during the 83d Con-
gress and subsequent Congresses, and
other Members of Congress introduced
numerous bills differing from the pro-
totype bills primarily with respect to
agency procedure and judicial review.
During the 83d Congress, the com-
mittee held hearings and reported
favorably related legislation providing
for the pretesting of, and the estab-
lishment of safe tolerances for, pesti-
cide chemicals. This bill was enacted
into law (Public Law 518, 83d Cong.).
During the 2d session of the 84th
Congress, the Subcommittee on Health
and Science, under the chairmanship
of the late full committee chairman,
J. Percy Priest, held 5 days of hearings
on 10 bills dealing with chemical addi-
tives in and on food. The hearings
indicated basic agreement with regard
to the need for chemical additive leg-
islation, but also considerable disagree-
ment with regard to the agency and
judicial review procedures to be fol-
lowed in determining the safety of
chemical additives. This disagreement
was not resolved, and no chemical addi-
tive legislation was enacted during the
84th Congress.
During the 85th Congress, the Sub-
committee on Health and Science held
11 days of hearings on 9 bills. The
hearings included 2 days of testimony
by a panel of outstanding scientists
and experts selected by the National
Academy of Sciences at the request of
the subcommittee, to give the subcom-
mittee the scientific background with
regard to the testing and evaluating of
the safety of chemical additives. The
subcommittee also heard witnesses
from industry, labor, and consumer
organizations, representatives from
the Department of Health, Education,
and Welfare, including those from the
Pood and Drug Administration, and the
chief judge of the third judicial circuit
appearing on behalf of the Judicial
Conference of the United States.
As a result of the hearings and after
consideration of the various bills, the
chairman of the subcommittee, Con-
gressman JOHN BELL WILLIAMS, of
Mississippi, introduced a clean bill—
H. R. 13254 — which was reported
unanimously by the subcommittee to
the full committee.
The full committee unanimously re-
ported the bill with one amendment
which strikes out all after the enacting
clause and inserts in place of the in-
troduced bill a substitute. The princi-
pal difference between the proposed
committee amendment and the intro-
duced bill is the elimination of the pro-
visions in the introduced bill relating
to scientific advisory committees. The
remaining differences are the result
of clerical, technical, and clarifying
changes.
Subsequently to the reporting of the
bill, as amended in the full committee,
the committee adopted unanimously a
further amendment to the amendment.
This amendment was suggested by Mr.
DELANEY who over the years since he
was the chairman of a Select Commit-
tee To Investigate the Use of Chemi-
cals in Poods and Cosmetics, has ex-
pressed his deep and abiding interest
in this subject. While the committee
felt that the bill as reported by the
committee includes the matter covered
by the Delaney amendment in the gen-
eral language contained in the bill,
there was no objection to the addition
of the amendment suggested by Mr.
DELANEY. This amendment would be
inserted on page 24, line 16 of the bill
H. R. 13254, as reported; before the
semicolon:
Provided, That no additive shall be deemed
to be safe if it is found to induce cancer when
ingested by man or animal, or if it is found,
-------
944
LEGAL COMPILATION—PESTICIDES
after tests which are appropriate for the evalu-
ation of the safety of food additives, to induce
cancer in man or animal.
The bill, as amended, has the ap-
proval of the Department of Health,
Education, and Welfare, and of the
organizations which represent the var-
ious industry groups which are affected
by this legislation. The letter of the
Department of Health, Education, and
Welfare, endorsing the bill, as amend-
ed, reads as follows:
Department of Health,
Education and Welfare,
Washington, August 8, 1958
Hon. OREN HARRIS,
Chairman, Committee on Interstate
and Foreign Commerce, House of
Representatives, Washington, D.C.
DEAR MR. CHAIRMAN: This is in reply to your
letter of August 5, 1958, acknowledging our
endorsement of H. R. 13254, the proposed Food
Additives Amendment of 1958, which was re-
ported favorably by our committee with an
amendment (in the nature of a substitute) on
July 28, 1958, and requesting an expression
of our additional views on the bill in view of
the amendments recommended by your com-
mittee.
The bill would require adequate testing of
the safety of so-called intentional or incidental
food additives, prior to their marketing and
use, so as to establish their safety under the
conditions of use to be specified by regulation.
Present law, though restrictive as to use of
known toxic substances in food, puts the bur-
den on the Government to prove that the sub-
stance is a poisonous or deleterious substance.
It may take two years or more of laboratory
tests on animals to establish this, thus leaving
the public without adequate protection in the
meantime.
The bill covers those additives not generally
recognized by competent experts as having been
adequately shown to be safe under the con-
ditions of their intended use. It covers sub-
stances that are added intentionally in foods
as well as those that may reasonably be ex-
pected to become a component of food inci-
dentally or to affect its characteristics. Irradi-
ation of food would be covered by the amend-
ment and would need to be established as safe
before commercial use.
Substances commonly used in food before
January 1, 1958, and generally recognized as
safe because of experience based on such use,
would be exempt from the law. Thus, sugar,
salt, butter, lard, pepper, and numerous other
ingredients would not have to go through the
clearance procedures of the bill-
Substances that get into food wholly acci-
dentally, such as paints, used in food processing
plants, are not covered by the legislation. These
accidental additives, if properly used, cannot
reasonably be expected to become a part of
food. If an accidental additive which is a poison-
ous or deleterious substance gets into food, the
food would be deemed adulterated and dealt
with under the basic 1938 law. The basic law
allows no tolerance for such additives.
Other additives not covered by the new amend-
ment are pesticide chemicals on raw agricul-
tural commodities which are already taken care
of under the Pesticide Chemicals Amendment
(Public Law 518, 83d Cong.) ; residues of pes-
ticide chemicals in processed foods which re-
sult from the proper use of raw materials that
have legal pesticide residues; and substances
that have already been approved for use in food,
under the Food, Drug, and Cosmetic Act, or in
the case of meats, under the Meat Inspection
Act.
Briefly, the new law would work as follows
fvith respect to additives within its scope:
1. A person who wants to promote a new
food additive would have to test it for safety
on animals and submit the results of the safety
tests to the Food and Drug Administration of
the Department of Health, Education, and Wel-
fare.
2. Scientists of the Food and Drug Admin-
istration would study the safety data and reach
an independent decision ag to the safety of the
new ingredient for use in our food supply. If
the data clearly demonstrate that the material
could be safely used, under certain conditions
of use, then this Department will, by order,
issue a regulation stating safe permissible uses
for the material. But if the safety of the addi-
tive is not reasonably certain, e.g., if the addi-
tive, in appropriate laboratory tests, indicates
a potential of inducing cancer, the Department
would not permit it and the public health would
be safeguarded in a way that has not been pos-
sible heretofore.
3. The Department would not be permitted
to sanction a use of an additive that promotes
deception of consumers in violation of other
provisions of the act or that otherwise would
result in misbranding or adulteration of food
within the meaning of the act. If the quantity
of the additive to be used must be limited to
safeguard health, then the Department could
not allow any quantity in excess of the amount
needed to accomplish the intended purpose, even
if a greater amount would still be safe. Even
the lower amount, of course, could not be al-
lowed unless it is safe.
4. A person adversely effected by the Secre-
tary's order would be entitled to a full admin-
[p. 17414]
istrative hearing on his objections. In case of
actual controversy as to the Secretary's action
after hearing, there would be a further oppor-
-------
STATUTES AND LEGISLATIVE HISTORY
945
tunity for judicial review of the validity of the
order on the basis of the record.
The Secretary's action after hearing would
have to be based upon a fair evaluation of
the entire record at the hearing. On judicial
review, the United States Court of Appeals
would be required to sustain the findings of
the Secretary if based upon a "fair evaluation
of the entire record at the hearing" ; it would
have to reverse the order of the Secretary if
it is not "based upon a fair evaluation of the
entire record" or if it fails to include a state-
ment setting forth in detail the findings and
conclusions upon which the order is based.
The "fair evaluation" provision is quite ac-
ceptable to the Department, because it is the
standard to which we are accustomed to adhere.
5. The amendment would become effective in
three stages:
(a) The Department would be authorized to
start making determinations as to the safety
o.f a food additive when the law is enacted.
(b) The provisions of section 3 of the legisla-
tion (which will have the effect of permitting
seizure, injunction suits, and criminal prose-
cutions on account of the shipment by inter-
state commerce of an additive or food con-
taining an additive, which has not been de-
termined to be safe) would take effect 180 days
after the enactment of the legislation. This is
required because it will take a certain amount
of time to make the necessary determinations
of safety.
(c) With respect to any particular commer-
cial use of a food additive which began before
January 1, 1958, industry would be allowed
12 months after the effective date of section 3
(18 months after date of enactment) to present
the necessary data to secure a regulation pre-
scribing the conditions under which the addi-
tive may be safely used. This would permit an
orderly transition from present procedures to
those of the amendment. Where there would be
no undue hazard to the public health and con-
ditions necessitate further extension, the Sec-
retary would have the authority to grant up
to an additional 12 months for this clearance
of old additive uses.
This is what is commonly referred to as the
"grandfather clause" of the legislation but it
is not a grandfather clause as that term is
generally used. The grandfather clause, as pro-
posed in some of the bills before your commit-
tee would have exempted substances used in
food prior to enactment of the legislation from
having to meet its requirements at all. This
Department opposed such a provision because
prior use in food would not be an adequate
substitute for a showing of safety.
In lieu of such a grandfather clause, the
present legislation, as indicated above, pre-
scribes a reasonable transition period which
will guarantee prompt decision on the status
of additives already in use in food and will
grant industry a reasonable period of time in
which to compile the data it has on the safety
of the additives and if necessary to perform
additional tests.
If the proposed legislation is not enacted,
substances of unknown toxicity, which would
be granted a limited time in which to meet
the safety provisions of H. R. 13254, may con-
tinue to be used indefinitely and additional
additives may be marketed for use in food
without any requirement that their safety
first be established. So a reasonable choice is
not between allowing the old additives or not
allowing them. The choice is between estab-
lishing their safety as soon as is practical un-
der the transition period allowed in H. R. 13254
or allowing their continued use without any
requirement that their safety he reevaluated.
However, the transitional period does not pro-
tect additives whose toxicity is known and
which are barred under present law. Food
containing such additives could meanwhile be
proceeded against under present law.
We would like, also, to make special men-
tion of: (1) The advisory committee procedure;
(2) the cancer question; and (3) the functional
value question.
1. The advisory committee procedure was in-
corporated in the proposed legislation which
this Department submitted to Congress (H. R.
6747) to give industry an opportunity to have
petitions reviewed by a panel of outside scien-
tists. We do not object to the committee's de-
letion of the procedure, because the Depart-
ment already has the privilege of making in-
quiry of competent outside scientists on tech-
nical matters.
2. The widespread interest in cancer led to
suggestions that the food additives legislation
should mention the disease by name and forbid
the approval of any substance that is found
upon test to cause cancer in test animals. This
Department is in complete accord with the in-
tent of these suggestions—that no substance
should be sanctioned for uses in food that
might produce cancer in man. H. R. 13254, as
approved by your committee, will accomplish
this intent, since it specifically instructs the
Secretary not to issue a regulation permitting
use of an additive in food if a fair evaluation
of the data before the Secretary fails to estab-
lish that the proposed use of the additive will
be safe. The scientific tests that are adequate
to establish the safety of an additive will give
information about the tendency of an additive
to produce cancer when it is present in food.
Any indication that the additive may thus be
carcinogenic would, under the terms of the bill,
restrain the Secretary from approving the pro-
posed use of the additive unless and until fur-
ther testing shows to the point of reasonable
certainty that the additive would not produce
cancer and thus would be safe under the pro-
posed conditions of use. This would afford
good, strong public health protection.
There are many serious conditions other than
-------
946
LEGAL COMPILATION—PESTICIDES
cancer that may be caused or aggravated by
the improper use of chemicals. It is manifestly
impracticable to itemize all of them in a bill.
To single out one class of diseases for special
mention would be anomalous and could be
misinterpreted. Hence, in drafting the Depart-
ment's bill (H. R. 6747) we chose general lan-
guage that would restrain any use of an addi-
tive that would have any adverse effect on the
public health* This approach has been followed
in H. R. 13254.
At the same time, if it would serve to allay
any lingering apprehension on the part of those
who desire an explicit statutory mandate on
this point, the Department would interpose no
objection to appropriate mention of cancer in
food additives legislation. If the specific dis-
ease were referred to in the law, it would, how-
ever, be important for everyone to have a clear
understanding that this would in no way re-
strict the Department's freedom in guarding
against other harmful effects from food addi-
tives.
It would be important, also, to use language
that would provide the intended safeguards
without creating unintended and unnecessary
complications. For example, the language sug-
gested by some to bar carcinogenic additives
would, if read literally, forbid the approval for
use in food of any substance that causes any
type of cancer in any test animal by any route
of administration. This could lead to unde-
sirable results which obviously were not in-
tended by those who suggested the language.
Concentrated sugar solution, lard, certain edible
vegetable oils, and even cold water have been
reported to cause a type of cancer at the site
of injection when injected repeatedly by hypo-
dermic needle into the same spot in a test
animal. But scientists have not suggested that
these same substances cause cancer when swal-
lowed by mouth.
The enactment of a law which would seem
to bar such common materials from the diet
on the basis of the evidence described above,
would place the agency that administered it
in an untenable position. The agency would
either have to try to enforce the law literally
so as to keep these items out of the diet—
evidently an impossible task—or it would have
to read between the lines of the law an intent
which would make the law workable, without
a clear guide from Congress as to what was
meant.
This difficulty could readily be avoided, if
there is still a desire to make specific mention
of cancer in the bill, by providing that "no
additive shall be deemed to be safe if it is
found to induce cancer when ingested by man
or animal, or if it is found, after tests which
are appropriate to the evaluation of the safety
of food additives, to induce cancer in animals."
Such language could be appropriately inserted
as a proviso before the semicolon on page 24,
line 16, of the bill as reported by your com-
mittee.
3. The functional value provision of this De-
partment's bill (H. R. 6747) was proposed to
prevent the useless addition of toxic chemicals
to food, to prevent the use of more of an addi-
tive which requires limitation in the interest
of safety than is needed to accomplish the in-
tended benefit, and to prevent deception of the
consumer. Some objected to this provision as
it appeared in H. R. 6747, in the belief that
it would require this Department, in some re-
spects, to make subjective judgments on ques-
tions not readily resolved on a factual basis.
H. R. 13254 is, clearly, not open to this objec-
tion but it retains the essential consumer pro-
tection features that were to be accomplished
by the functional value provision in the follow-
ing manner:
(a) If the additive requires a tolerance limi-
tation to insure its safe use:
(1) The Secretary may permit the proposed
use only if the data before him show that it
would accomplish the intended physical or other
technical effect. This would prevent the useless
additional toxic chemicals to food.
(2) The Secretary would only fix the toler-
ance limitation at the level reasonably required
to accomplish the physical or other technical
effect (provided, of course, this level is safe).
This would prevent the use of more of a toxic
chemical than is needed to accomplish the in-
tended effect.
(b) The Secretary would be forbidden to
permit use of an additive if the data before
him showed that the proposed use would pro-
mote deception of the consumer in violation
of, or would otherwise result in adulteration
or misbranding within the meaning of the Fed-
eral Food, Drug, and Cosmetic Act.
In conclusion, we strongly urge the enact-
ment of the bill by the present Congress in
order to close a serious gap in the present law.
In view of the urgency of this report, time
has not permitted its submission to the Bu-
reau of the Budget for advice in accordance
with the usual procedure.
Sincerely yours,
Elliot L. Richardson
Assistant Secretary
Great credit is due the chairman
and the members of the Subcommittee
on Health and Science who worked so
conscientiously to bring about sub-
stantially unanimous agreement with
regard to this legislation which has
been in the making for 6 years.
Instead of attempting to explain the
bill, as amended, section by section, I
feel that it would be easier to present
-------
STATUTES AND LEGISLATIVE HISTORY
947
an analysis of the principal provisions
of this legislation.
[p. 17415]
Mr. POFF. Mr. Speaker, I am in
favor of the bill.
Mr. Speaker, I applaud and com-
mend the chairman and members of
the Committee on Interstate and For-
eign Commerce for their work and the
results of their work on H. R. 13254
to amend the Federal Food, Drug, and
Cosmetic Act to prohibit the use in
food of additives which have not been
adequately tested to establish their
safety for human consumption.
As I understand the bill, pretesting
of additives is required only with re-
spect to those food additives which are
not generally recognized among com-
petent experts as having been ade-
quately shown to be safe under the
conditions of their intended use. An
additive may be shown to be safe either
by means of scientific procedures or,
in the case of substances in use prior to
January 1, 1958, by means of experi-
ence based on common use in food.
The legislation covers substances
which are added intentionally to food.
These additives are generally referred
to as intentional additives.
The legislation also covers sub-
stances which may reasonably be ex-
pected to become a component of any
food or to affect the characteristics of
any food. These substances are gener-
ally referred to as incidental additives.
The principal examples of both in-
tentional and incidental additives are
substances intended for use in produc-
ing, manufacturing, packaging, trans-
porting, or holding food.
*****
[p. 17418]
Mr. McDONOUGH. Mr. Speaker, I
was a member of the Delaney commit-
tee which held numerous hearings on
this subject in various parts of the
United States. Although this legisla-
tion is necessary in order to protect
the public, in my opinion, it is not as
positive nor as strong as it should be
on the basis of our hearings and the
information that we obtained from wit-
nesses. It is necessary largely because
of the increase in the number of ven-
dors and the competition between the
various vendors of foods with added
chemical additives to make the foods
look better but which sometimes re-
duces the protein value and the nutri-
tive value of the food. It is unfortunate
that we have to have such legislation
as this, but we have found it is neces-
sary. Great volumes of food are
turned out. All kinds of food is pro-
duced in ways to make it more attrac-
tive and to make it easier to bake
cakes and to make it easier to bake pies
and to make it easier to keep bread
from molding on the shelves and so on,
but with very little thought in many
instances given to the effect these
chemicals have on the nutritive value
of the food. I favor this legislation as
one means of protecting the public
because I think that many of these
chemicals are very dangerous in many
instances and may be harmful to the
health of many people throughout the
Nation. These additives should be pre-
tested before they are used. I trust,
however, that the Committee on Inter-
state and Foreign Commerce will give
further study and consideration to
chemical additives to food and propose
additional legislation to control the
use of dangerous and deleterious chem-
icals which could and may be the
source of infectious and contagious
disease. The public health must be
protected. Some of the cases that the
Delaney committee heard testimony
about from competent witnesses cre-
ated doubt as to whether the use of
these chemical additives in food did or
did not create favorable conditions for
the development of cancerous growth
and other noxious diseases.
The following parts of the commit-
tee report on H. R. 13254 will give its
purpose, history, and powerful provi-
-------
948
LEGAL COMPILATION—PESTICIDES
PURPOSES OF LEGISLATION
The purpose of the legislation is twofold;
1. To protect the health of consumers by re-
quiring manufacturers of food additives and
food processors to pretest any potentially unsafe
substances which are to be added to food ; and
2. To advance food technology by permitting
the use of food additives at safe levels.
Existing law bars the use, even at safe levels,
of additives which are poisonous or deleterious
unless their use is required in production or
cannot be avoided by good manufacturing prac-
tice. The Federal Government in order to pre-
vent the use of an additive must prove that
it is a poisonous or deleterious substance. The
law thus gives rise to a dual problem. On the
one hand, to prove an untested substance poi-
sonous or deleterious may require approximately
2 years or more of laboratory experiments with
small animals and during this period the Gov-
ernment cannot prevent the use of such a sub-
stance in food. On the other hand, present law
entirely prohibits the use of these additives
even if their use at safe levels would advance
our food technology and increase and improve
our food supplies.
The Food and Drug Administration has
pointed out the dangers to the public health
resulting from the failure of the present law
to require pretesting of food additives. On the
other hand that agency agrees that the present
law should be changed to permit the use of
additives at safe levels in order to advance our
food technology.
While the responsible elements of the af-
fected industries traditionally have voluntarily
undertaken to pretest food additives they are
willing to assume this responsibility under a
statutory mandate. Thus, those elements of the
industry which in the past have used harmful
additives or additives of unknown toxicity with-
out pretesting will in the future under this
legislation be required to assume the same duties
as the responsible elements have heretofor vol-
untarily assumed.
Although there has been complete agreement
as to the need for this legislation, there have
been differences between the Food and Drug
Administration and the affected industries with
respect to procedures to be followed in deter-
mining the safety of an additive and the method
of judicial review of such a determination. With
respect to these controversial procedural ques-
tions, the committee feels the proposed legisla-
tion steers a course which satisfies both the
need for protecting the public health and the
legitimate interests of industry and Government
in fair procedures.
*****
[p. 17422]
PRINCIPAL PROVISIONS OP LEGISLATION
Substances covered by legislation
The legislation covers substances which are
added intentionally to food. These additives
are generally referred to as intentional addi-
tives.
The legislation also covers substances which
my reasonably be expected to become a com-
ponent of any food or to affect the character-
istics of any food. These substances are gen-
erally referred to as incidental additives.
The principal examples of both intentional
and incidental additives are substances in-
tended for use in producing, manufacturing,
packing, processing, preparing, treating, pack-
aging, transporting, or holding food.
On the other hand, substances which may
accidentally get into a food, as for example,
paints or cleaning solutions used in food-proc-
essing plants, are not covered by the legislation.
These additives are generally referred to as
accidental additives, since these substances if
properly used may not reasonably be expected
to become a component of a food or otherwise
to affect the characteristics of a food. If acci-
dental additives do get into food, the provisions
of the Food, Drug, and Cosmetic Act dealing
with poisonous and deleterious substances would
be applicable.
Sources of radiation (including radioactive
isotopes, particle accelerators and X-ray ma-
chines) intended for use in processing food
are included in the term food additive as de-
nned in this legislation.
Exempted from the scope of the legislation
are (1) pesticide chemicals in or on raw agri-
cultural commodities which are already cov-
ered by the pesticide chemicals amendment to
the Federal Food, Drug, and Cosmetic Act
(Public Law 518 83d Cong.) ; (2) residues of
pesticide chemicals unavoidably remaining on
processed foods not in excess of tolerances
prescribed by Food and Drug Administration
for raw agricultural commodities; and (3) sub-
stances already approved under the provisions
of the Federal Food, Drug, and Cosmetic Act
or the Meat Inspection Act of March 4, 1907.
The Secretary is given authority by this legis-
lation to exempt by regulation food additives
for investigational use by qualified experts
when consistent with the public health.
Mr. HARRIS.
[p. 17423]
NEXT OBJECTIVE : SAFETY OF COSMETICS
Mr. Speaker, I am pleased that we
are finally passing a bill on chemical
additives in food after all of these
years of effort. I wish it were a better
bill. But it can accomplish a great deal
of good if it is enacted into law. I con-
gratulate all of those Members who
have had a part in shaping the bill,
-------
STATUTES AND LEGISLATIVE HISTORY
949
and I sincerely hope the Senate will
have an opportunity to act on the leg-
islation so that a bill can be sent to the
White House.
I now serve notice, Mr. Speaker, that
I intend to do everything I can be-
ginning at the start of the next session
of Congress to enact similar legislation
dealing with the safety of materials
and chemicals used in cosmetics. I hope
it does not take as long on that as it
has taken to get action on the food
additives. The problem is much the
same and the solution also is much the
same—that is, legislation to require
the manufacturers to prove the safety
of the chemicals they use rather than
to force the Government to prove the
chemicals to be unsafe.
The SPEAKER. The question is:
Will the House suspend the rules and
pass the bill, as amended?
The question was taken; and (two-
thirds having voted in favor thereof)
the rules were suspended and the bill
was passed.
A motion to reconsider was laid on
the table. [p. 17424]
l.lOc (3) (b)
19359
Aug. 23: Amended and passed Senate, pp. 19358-
PROHIBITION OF USE OF
UNTESTED ADDITIVES IN FOOD
The PRESIDING OFFICER. Cal-
endar No. 2487, House bill 13254, was
passed to the foot of the calendar. The
bill will be stated by title for the in-
formation of the Senate.
The LEGISLATIVE CLERK. A bill (H.
R. 13254) to protect the public health
by amending the Federal Food, Drug,
and Cosmetic Act to prohibit the use
in food of additives which have not
been adequately tested to establish
their safety.
Mr. HILL. Mr. President, I ask
unanimous consent to have printed in
the RECORD at this point a statement
which I have prepared on the bill.
There being no objection, the state-
ment was ordered to be printed in the
RECORD, as follows:
This hill, which is the result of some 6 years
of very intensive hearings held by the House
Committee on Interstate and Foreign Com-
merce, was reported unanimously by that com-
mittee to the House, passed the House without
dissent and has been unanimously reported by
the Committee on Labor and Public Welfare.
The bill has as ita objective the correction
of two deficiencies in the existing laws under
which we undertake to assure the safety of the
foods sold to the people of the United States.
In the first place, this legislation would re-
quire the processor of foodstuffs who proposes
to add to the food any new chemical additive
to first prove that the proposed addition will
be safe. Under present law the burden of prov-
ing any particular additive poisonous or dele-
terious to humans lies with the Food and Drug
Administration. Sometimes a chemical may be
added to foodstuffs and used for a considerable
period of time before anyone begins to suspect
that it may be having ill effects. When and if
suspicion has been aroused, more time passes
before the Food and Drug Administration can
schedule it for investigation. The scientists of
our Food and Drug Administration then un-
dertake investigatory procedures involving test-
ing the chemical additives on small animals.
This may take 2 years or even longer. In the
meantime, millions of people may be eating
the foodstuffs containing the perhaps seriously
deleterious additive. An overwhelming percent-
age of America's food processors of course have
[p.19358]
voluntarily undertaken to thoroughly test any
additives before using them. This bill would
require that all processors do so and that no
new additives be used without their safety
having first been established. The burden of
proof is placed where it belongs: Not on the
Government, but on the concern which intends
to add the chemical to our food.
The second change in existing law would
permit American industry to promote new
technological developments in food handling
calculated to make foods more tasteful and
appetizing, to enable them to be kept longer,
or to otherwise improve them, through the
use of additives now proscribed under a blan-
ket provision of existing law. This legislation,
which has the approval of the Food and Drug
Administration, would permit the use of addi-
tives at safe levels in order to advance our
food technology.
I have said that the bill before us passed the
House unanimously. I have also pointed out
that it has the support of the Food and Drug
Administration, which is charged by law with
-------
950
LEGAL COMPILATION—PESTICIDES
responsibility for protecting the public's health
with respect to the foods it eats. I am happy,
Mr. President, to be able to also announce that
our records indicate that this measure now has
the overwhelming support of the major indus-
trial and business concerns which "would be
affected by it. Its prompt passage is urged not
only by the Administration and the committee
but by such business groups as:
"National Canners Association; National
Dairy Products Corp.; Kraft Foods Division;
Grocery Manufacturers of America; Millers
National Federation; American Bakers Asso-
ciation ; Manufacturing Chemists Association;
and the Dairy Industry Committee, speaking
for: the American Butter Institute; the Ameri-
can Dairy Milk Institute; the Evaporated Milk
Association; the International Association of
Ice Cream Manufacturers; the Milk Industry
Foundation ; the National Cheese Institute ; and
the National Creameries Association.
The bill will further strengthen the adminis-
tration of the Pure Food and Drug Act and the
protection afforded the American people by that
act.
Mr. President, I note the presence of the dis-
tinguished senior Senator from Montana, Mr.
MURRAY. He is a former chairman of the Sen-
ate Committee on Labor and Public Welfare and
is always greatly interested in the strengthening
of the Pure Food and Drug Act. We owe much
to him and his able and devoted leadership.
Questions were raised concerning the inter-
pretation of two words in the bill. The questions
were taken up with the Department of Health,
Education, and Welfare. Following is a letter
from the Department giving its interpretation
of those words:
DEPARTMENT OP HEALTH,
EDUCATION, AND WELFARE,
Washington, August 20, 1S58
Hon. LISTER HILL,
Chairman, CommitteB on Labor, and
Public Welfare, United States Senate.
Washington, D.C.
DEAR MR. CHAIRMAN: Two questions have
arisen about the correct interpretation and the
legislative intent of section 2 of H. R. 13254,
referred to as the "Food Additives Amendment
of 1958." Those questions, and the viewpoints
of this Department and of the Food and Drue
Administration, are as follows:
1. Does the word "substance," as used in that
section, include a food or food component con-
sisting of two or more ingredients? Our inter-
pretation is in the affirmative.
2. Do the words "common use," as used in
that section, include a wide use of such a sub-
stance by many consumers, even though such a
substance may have been used by only a single
manufacturer of food or food components ?
Again cur answer is in the affirmative.
We would greatly appreciate it if you would
place this letter in the CONGRESSIONAL
RECORD in connection with the presentation
of the bill for Senate consideration.
Sincerely yours,
ELLIOT L. RICHARDSON,
Assistant Secretary
I would add that the term "other-
wise affecting the characteristics of
any food" refers to an effect not gener-
ally recognized as safe among experts
qualified by scientific training and ex-
perience to evaluate the safety of food
additives; but innocuous effects of
packaging, such as protection from
dirt, retarding moisture loss, preserv-
ing shape, providing convenience in
use, handling and storage, and the like,
would not be covered.
The PRESIDING OFFICER. Is
there objection to the present consider-
ation of the bill?
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 15, after line 5,
to insert a new section, as follows:
SEC. 8. The annual rate of basic compensation
of the Commissioner of Food and Drugs shall
be $20,000.
And after line 7, to insert a new sec-
tion, as follows:
SEC. 9. Section 208 (g) of the Public Health
Service Act, as amended (42 U.S.C. 210 (g)),
is amended by striking out the phrase "in the
professional and scientific service" and insert-
ing in lieu thereof the phrase "in the profes-
sional, scientific, and executive service" and by
striking out the phrase "of specially qualified
scientific or professional personnel" and in-
serting in lieu thereof "of specially qualified
scientific, professional, and administrative per-
sonnel."
Mr. HILL. Mr. President, I ask that
the committee amendments be agreed
to en bloc.
The PRESIDING OFFICER. With-
out objection, it is so ordered.
Mr. WILLIAMS. Mr. President, I
offer the amendments which I send to
the desk and ask to have stated.
The PRESIDING OFFICER. The
amendments 'offered by the Senator
from Delaware will be stated.
The LEGISLATIVE CLERK. On page 2,
-------
STATUTES AND LEGISLATIVE HISTORY
951
line 21, after the word "Act," it is pro-
posed to insert the following: ", the
Poultry Products Inspection Act (21
U.S.C. 451 and the following)."
On page 15, line 3, after the words
"pursuant to," it is proposed to insert
the following: "the Poultry Products
Inspection Act (21 U.S.C. 451 and the
following) or."
Mr. HILL. Mr. President, let me say
to the distinguished Senator from Del-
aware that these are very fine amend-
ments. The Department of Agriculture
favors the amendments. The Depart-
ment of Health, Education, and Wel-
fare has no objection to them. I hope
the amendments may be agreed to.
The PRESIDING OFFICER. The
question is on agreeing to the amend-
ments offered by the Senator from
Delaware.
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. 19359]
l.lOc (3) (c) Aug. 23: House concurs in Senate amendment,
p.19641
[No Relevant Discussion on Pertinent Section]
l.lOd COLOR ADDITIVE AMENDMENTS OF 1960
July 12, I960, P.L. 86-618, Title I, §§102(a) (1), (2), 105(c), 74 Stat. 397, 404
COLORS OE COLORED ARTICLES—WHEN DEEMED TO BE
ADULTERATED OR MISBRANDED FOODS, DRUGS, OR COSMETICS
Food
SEC. 102. (a) (1) Clause (2) (A) of section 402 (a), as
amended, of such Act (relating to food deemed adulterated by
reason of unsafe additives) is further amended by striking out
the matter within the parentheses and inserting in lieu thereof
the following: "other than one which is (i) a pesticide chemical
[p. 397]
in or on a raw agricultural commodity; (ii) a food additive; or
(iii) a color additive".
(2) Section 402 (c), as amended, of such Act (relating to food
deemed adulterated by reason of uncertified coal-tar color) is
amended to read as follows:
"(c) If it is, or it bears or contains, a color additive which is
unsafe within the meaning of section 706 (a)."
[p.398]
CHANGES IN CROSS-REFERENCES AND TERMINOLOGY
SEC. 105. Such Act is further amended by— r 403-1
*******
(c) striking out "harmless coloring" in section 402 (d) (relat-
ing to nonnutritive substances in confectionery) and inserting in
lieu thereof "authorized coloring". r , „ ...
Lp. 404]
-------
952 LEGAL COMPILATION—PESTICIDES
l.lOd (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 favor-
ably thereon with amendments and recommend that the bill, as
amended, do pass.
EXPLANATION
S. 2197 is designed to better protect the public health with res
pect to procedures necessary to assure the safety of color addi
tives in foods, drugs, and cosmetics and to authorize the use o
such color additives as have been predetermined to be perfect!:
safe in the amounts in which they are to be used. The bill i
designed to meet a pressing need for replacing the inconsistent
and in part outmoded, provisions which now govern the use o
different kinds of color for articles covered by the Federal Fooc
Drug, and Cosmetic Act with a scientifically sound and uniforr
system for the listing of color additives of any kind which may b
safely used in food, drugs, or cosmetics, subject, when necessary
to appropriate tolerance limitations and other conditions of us
and to official certification of batches of color so as to assure th
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 Fooi
and Drug Administration as harmless and suitable for use. i
recent Supreme Court decision has defined the "harmless" prir
ciple as meaning harmless regardless of the quantity of the coa
tar color which is being used. Thus, a color must be certified if an
[p.l
-------
STATUTES AND LEGISLATIVE HISTORY 953
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 "harm-
less" 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
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
tolerance 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.
[p. 2]
-------
9Ł4 LEGAL COMPILATION—PESTICIDES
II. SECTIONAL ANALYSIS
TITLE I—AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETICS ACT
*******
Section 102 (a)
Paragraph (1) adds color additives to the exceptions from sec-
tion 402(a) (2) (A) of the act, which now declares adulterated
any food bearing or containing a poisonous or deleterious added
substance which is unsafe within the meaning of section 406 of
the act "except a pesticide chemical in or on a raw agricultural
commodity and except a food additive." This paragraph of the
bill makes explicit, with regard to color additives, the interpre-
tation of the Supreme Court in Flemming v. Florida Citrus
Exchange, 358 U.S. 153 (1958), that section 406(a) of existing
law—which authorizes the establishment of tolerances for poison-
ous or deleterious substances added to food where the additive is
required in the production of the food or cannot be avoided by
good manufacturing practice—cannot serve as a basis for allow-
ing the use of coal-tar colors where marketability of a food depends
on such coloring. Under the bill, section 706 of the act would
(except during a transitional period) provide the exclusive proce-
dure for the listing (with or without tolerance limitations) and
certification of color additives.
Paragraph (2) amends section 402 (c) to deem a food adulter-
ated if "it is, or it bears or contains," a "color additive" which is
"unsafe within the meaning of section 706(a)" of the basic act as
[p. 13]
enacted by the bill. This would replace the present requirement of
section 402 (c) that deems adulterated a food bearing a coal-tar
color which is not from a batch certified under section 406 (b), and
the provisos to section 402 (c) with respect to the use of color on
oranges. (See Public Law 86-2.) (Sec. 406(b) of the act would be
repealed under another section of the bill.) The effect of these
changes would be to (a) make the new provisions applicable to all
color additives, whether or not they are coal-tar colors; (b) extend
them to the color additive itself before being added to food; and
(c) use the technique of the pesticide chemicals amendment and
food additives amendment by deeming the article adulterated if
the additive is "unsafe" under another section (in this case the
amended sec. 706) of the basic act which sets forth the criteria
under which the additive shall be deemed unsafe. r ., „,
[p. 14]
Section 105
Contains appropriate changes of cross-references in, and other
-------
STATUTES AND LEGISLATIVE HISTORY 955
conforming amendments to, section 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 17]
CHAPTER IV—FOOD
ADULTERATED FOOD
SEC. 402. A food shall be deemed to be adulterated—
(a) (1) If it bears or contains any poisonous or deleterious
substance which may render it injurious to health; but in case the
substance is not an added substance such food shall not be con-
sidered adulterated under this clause if the quantity of such
substance in such food does not ordinarily render it injurious to
health; or (2) (A) if it bears or contains any added poisonous or
added deleterious substance, [except a pesticide chemical in or on
[p. 21]
a raw agricultural commodity and except food additive) ] (other
than one which is (i) a pesticide chemical in or on a raw agricul-
tural commodity; (ii) a food additive; or (in) a color additive)
which is unsafe within the meaning of section 406, or
*******
(B) if it is a raw agricultural commodity and it bears or contains a
pesticide chemical which is unsafe within the meaning of section
408 (a) ; or (C) if it is, or it bears or contains, any food additive
which is unsafe within the meaning of section 409: Provided, That
where a pesticide chemical has been used in or on a raw agricul-
tural commodity in conformity with an exemption granted or a
tolerance prescribed under section (3) if it consists in whole or in
part of any filthy, putrid, or decomposed substance, or if it is
otherwise unfit for food; or (4) if it has been prepared, packed, or
held under insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been rendered
injurious to health; or (5) if it is, in whole or in part, the product
of a diseased animal or of an animal which has died otherwise than
by slaughter; or (6) if its container is composed, in whole or in
part, of any poisonous or deleterious substance which may render
the contents injurious to health; or (7) if it has been intentionally
subjected to radiation, unless the use of the radiation was in
conformity with a regulation or exemption in effect pursuant to
section 409 2a.
(b) (1) If any valuable constitutent has been in whole or in part
omitted or abstracted therefrom; or (2) if any substance has been
-------
956 LEGAL COMPILATION—PESTICIDES
substituted wholly or in part therefor; or (3) if damage or inferi-
ority has been concealed in any manner; or (4) if any substance
has been added thereto or mixed or packed therewith so as to
increase its bulk or weight, or reduce its quality or strength, or
make it appear better or of greater value than it is.
[ (c) If it bears or contains a coal-tar color other than one from
a batch that has been certified in accordance with regulations as
provided by section 406: . . . Provided . . . That, without regard to
the requirements of section 406 (b) and 701 (e), the Secretary shall
promptly establish, and may from time to time amend, regulations
(1) prescribing the conditions (including quantitative tolerance
limitations) under which the coal-tar color known as Citrus Red
No. 2 (more particularly to be denned in such regulations) may
be safely used in coloring the skins of oranges which are not
intended or used for processing (or, if so used, are oranges desig-
nated in the trade as "packing house elimination"), and which
meet minimum maturity standards established by or under the
laws of the States in which the oranges are grown, (2) providing
for separately listing such color solely for such use on such oranges,
and (3) providing for the certification of batches of such color,
with or without harmless diluents, for such restricted use; and
such oranges, if colored prior to September 1, 1961, and to the
enactment by the Congress (subsequent to the date of enactment
of this proviso) of general legislation for the listing and certifica-
tion of food color additives under safe tolerances, in conformity
with this proviso and such regulations, with Citrus Red No. 2 from
a batch certified in accordance with such regulations, shall not be
deemed to be adulterated within the meaning of this paragraph.]
(c) If it is, or it bears or contains, a color additive which is
unsafe within the meaning of section 706(a).
[p. 22]
(d) If it is confectionery, and it bears or contains any alcohol or
nonnutritive article or substance except [harmless coloring]
authorized coloring, harmless flavoring, harmless resinous glaze
not in excess of four-tenths of 1 per centum, natural gum, and
pectin: Provided, That this paragraph shall not apply to any
confectionery by reason of its containing less than one-half of 1
per centum by volume of alcohol derived solely from the use of
flavoring extracts, or to any chewing gum by reason of its contain-
ing harmless nonnutritive masticatory substances.
*******
[p. 23]
-------
STATUTES AND LEGISLATIVE HISTORY 957
l.lOd (2) HOUSE COMMITTEE ON INTERSTATE AND
FOREIGN 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 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:
*******
PURPOSE OF LEGISLATION '•p'
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
cosmetics 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 list-
ing of suitable "color additives," safe for use in food, drugs,
-------
958 LEGAL COMPILATION—PESTICIDES
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
distinguished group of scientific experts, selected by the President
of the National Academy of Sciences, which discussed the scientific
problems involved in this legislation, with special emphasis on
the Delaney anticancer clause.
BACKGROUND INFORMATION
Under the Federal Food, Drug, and Cosmetic Act, the treatment
of color additives differs radically as between so-called coal-tar
colors and other colors.
1. Coalrtar colors.—The term "coal-tar color" has been inter-
preted to apply not only to substances which are coal-tar deriva-
tives but also to synthetic substances so related in their chemical
structure to a coal-tar constituent as to be capable of derivation
therefrom even when not actually so derived.
So-called coal-tar colors are regulated under the act through
similar sets of provisions in chapters IV (food), V (drugs), and
VI (cosmetics). The act requires the Secretary of Health, Educa-
tion, and Welfare to provide by regulation for listing and certify-
ing batches of "coal-tar colors which are harmless and suitable for
use" in food, drugs, and cosmetics.
Food containing a coal-tar color is deemed adulterated under
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 Secretary to provide for listing coal-tar colors that are harm-
less 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
-------
STATUTES AND LEGISLATIVE HISTORY 959
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 cosmetic (other than a hair dye, which is defined to exclude
eyelash and eyebrow dyes) containing a coal-tar color is deemed
adulterated by section 601 (e) unless the color is from a batch
certified by the Secretary under section 604. Section 604 then
directs the Secretary to provide for listing of coal-tar colors that
are harmless and suitable for use in cosmetics, and for certifying
batches of such colors.
The Secretary of Health, Education, and Welfare is without
authority to admit a coal-tar color to listing under tolerance limi-
tations ; it must be harmless per se in order for the Secretary to
admit it to listing (Flemming v. Florida Citrus Exchange, 358 U.S.
153 (1958)).
One exception to the prohibition against the listing of a coal-tar
color under tolerance limitations was made by the Congress in
Public Law 86-2 to permit the temporary listing and certification
of the color Citrus Red No. 2 for the coloring of mature oranges
under tolerances found to be safe by the Secretary of Health,
Education, and Welfare.
2. Other colors.—A coloring material not classified as a coal-tar
color is not subject to any pretesting, listing, or certification
requirements 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.
Non-coal-tar coloring materials used in food, when such materi-
als are not generally recognized by experts as safe, are classified 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 to be
adulterated if the additive is unsafe within the meaning of section
409. Under section 409 the food additive is deemed unsafe unless
it and its use, or intended use, conform to a regulation issued by
the Secretary announcing the conditions, including the establish-
ment of tolerance limitations, under which the additive may be
safely used. Food colors which were in commercial use before
January 1, 1958, are allowed a grace period not later than March
6, 1961, for compliance with the provisions of the Food Additives
Amendment of 1958. Such "food additive" colors, however, are not
subject to any requirement of "batch" certification. r „,
Lp- «]
-------
960 LEGAL COMPILATION—PESTICIDES
EXPLANATION OF PRINCIPAL COMMITTEE
AMENDMENTS
(1) Agricultural chemicals affecting color (p. 3, beginning on
line 10 of reported bill)
The committee was advised that certain pesticide chemicals
used in fruit production have the effect not only of protecting the
trees against plant diseases but also of supporting or otherwise
affecting natural plant processes which thus result in the produc-
tion of better color and finish in the fruit. Also, some plant growth
regulators, when applied to plants, likewise enhance the develop-
ment of normal color in the produce of such plants. Some fear has
been expressed that such chemicals and plant regulators could be
considered to fall within the scope of the definition of "color addi-
tive" in section 101 (c) of the bill since they have the ability to
promote the coloring of raw agricultural commodities.
The committee agrees with the Secretary of Health, Education,
and Welfare that such chemicals and plant nutrients are not color
additives within the meaning of the basic definition of color addi-
tive in this bill, since they merely promote the development of the
natural color of produce as the result of the normal physiological
processes of the plant or produce. To make this clear, however, the
committee has inserted an amendment to the effect that the term
"color additive" in section 101 (c) of the bill shall not be construed
to apply to any pesticide chemical, soil or plant nutrient, or other
agricultural chemical which affects the color of fruit or other raw
agricultural commodity which is the produce of the soil solely
through its effect on plant metabolism or enzymatic processes
either before or after harvest. Pesticide chemicals are regulated
under section 408 of the Federal Food, Drug, and Cosmetic Act
and under the Federal Insecticide, Fungicide, and Rodenticide Act
(61 Stat. 163; 7 U.S.C. 135-135k), and there is no necessity for
subjecting them to additional regulation under the color additive
amendments when their sole effect on color is through such meta-
bolic or enzymatic processes.1
It is not the intention of the committee, however, to exempt from
the provisions of this bill any chemical or nutrient if it also con-
tains a dye, pigment, or other substance whose function is to
impart color to the fruit or other raw agricultural commodity.
The views of the Secretary of Health, Education, and Welfare in
1 Under a recent amendment to the Federal Insecticide, Fungicide, and Rodenticide Act (Pub-
lic Law 86-139) nematocides, plant regulators, defoliants, and dessicants have been classified as
pesticide chemicals.
-------
STATUTES AND LEGISLATIVE HISTORY 961
letters to the committee dated February 8,1960, and April 21,1960,
and the letter of the Assistant Secretary of Agriculture dated April
14, 1960, expressing their views on this subject, in which the
committee concurs, are shown in the appendix to this report.
*******
SECTION-BY-SECTION ANALYSIS OF
"COLOR ADDITIVE AMENDMENTS OF 1960"
Section 102(a)
Paragraph (1) adds color additives to the exceptions from sec-
tion 402 (a) (2) (A) of the act, which now declares adulterated any
food bearing or containing a poisonous or deleterious added sub-
stance which is unsafe within the meaning of section 406 of the act
"except a pesticide chemical in or on a raw agricultural commodity
and except a food additive." Under the bill, section 706 of the act
would (except during a transitional period) provide the exclusive
procedure for the listing (with or without tolerance limitations)
and certification of color additives.
Paragraph (2) amends section 402 (c) to deem a food adulter-
ated if "it is, or it bears or contains," a "color additive" which is
"unsafe within the meaning of section 706(a)" of the basic act as
enacted by the bill. This would replace the present requirement of
section 402 (c) that deems adulterated a food bearing a coal-tar
color which is not from a batch certified under section 406 (b), and
;he provisos to section 402 (c) with respect to the use of color on
jranges. (See Public Law 86-2.) (Sec. 406 (b) of the act would be
•epealed under another section of the bill.) The effect of these
changes would be to (a) make the new provisions applicable to all
;olor additives, whether or not they are coal-tar colors; (b) extend
;hem to the color additive itself before being added to food; and
(c) use the technique of the pesticide chemicals amendment and
!ood additives amendment by deeming the article adulterated if the
idditive is "unsafe" under another section (in this case the amend-
ed sec. 706) of the basic act which sets forth the criteria under
vhich the additive shall be deemed unsafe.
lection 105 [p'23]
Contains appropriate changes of cross-references in, and other
:onforming amendments to sections 301 (i) (false use of required
narks), 303 (c) (3) (guarantee that coal-tar color is certified), and
02 (d) (nonnutritive substances in confectionery) of the basic act.
[p. 29]
-------
962 LEGAL COMPILATION—PESTICIDES
CHAPTER IV—FOOD
*******
ADULTERATED POOD
SEC. 402. A food shall be deemed to be adulterated—
(a) (1) If it bears or contains any poisonous or deleterious sub-
stance which may render it injurious to health; but in case the
substance is not an added substance such food shall not be consid-
ered adulterated under this clause if the quantity of such substance
in such food does not ordinarily render it injurious to health; or
(2) (A) if it bears or contains any added poisonous or added dele-
terious substance [ (except a pesticide chemical in or on a raw
agricultural commodity and except a food additive) ] (other than
one which is (i) a pesticide chemical in or on a raw agricultural
commodity; (ii) a food additive; or (Hi) a color additive) which is
unsafe within the meaning of section 406, or (B) if it is a raw
agricultural commodity and it bears or contains a pesticide chem-
ical which is unsafe within the meaning of section 408 (a) ; or
(C) if it is, or it bears or contains, any food additive which is
unsafe within the meaning of section 409: Provided, That where
a pesticide chemical has been used in or on a raw agricultural
commodity in conformity with an exemption granted or a toler-
ance prescribed under section 408 and such raw agricultural com-
modity has been subjected to processing such as canning, cooking,
freezing, dehydrating, or milling, the residue of such pesticide
chemical remaining in or on such processed food shall, notwith-
standing the provisions of sections 406 and 409, not be deemed
unsafe if such residue in or on the raw agricultural commodity
has been removed to the extent possible in good manufacturing
practice and the concentration of such residue in the processed
food when ready to eat is not greater than the tolerance prescribed
for the raw agricultural commodity; or (3) if it consists in whole
or in part of any filthy, putrid, or decomposed substance, or if it
is otherwise unfit for food; or (4) if it has been prepared, packed,
or held under insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been rendered
injurious to health; or (5) if it is, in whole or in part, the product
of a diseased animal or of an animal which has died otherwise
than by slaughter; or (6) if its container is composed, in whole or
in part, of any poisonous or deleterious substance which may render
the contents injurious to health; or (7.) if it has been intentionally
subjected to radiation, unless the use of the radiation was ir
conformity with a regulation or exemption in effect pursuant tc
section 409.
-------
STATUTES AND LEGISLATIVE HISTORY 963
(b) (1) If any valuable constitutent has been in whole or in part
omitted or abstracted therefrom; or (2) if any substance has been
substituted wholly or in part therefor; or (3) if damage or inferi-
ority has been concealed in any manner; or (4) if any substance
has been added thereto or mixed or packed therewith so as to
increase its bulk or weight, or reduce its quality or strength, or
make it appear better or of greater value than it is.
[ (c) If it bears or contains a coal-tar color other than one from a
batch that has been certified in accordance with regulations as pro-
vided by section 406: Provided, That this paragraph shall not
apply to citrus fruit bearing or containing a coal-tar color if
application for listing of such color has been made under this Act
[p. 37]
and such application has not been acted on by the Secretary, if
such color was commonly used prior to the enactment of this Act
for the purpose of coloring citrus fruit: Provided further, That
this paragraph shall not apply to oranges meeting minimum
maturity standards established by or under the laws of the States
in which the oranges were grown and not intended for processing
(other than oranges designated by the trade as "packing house
elimination"), the skins of which have been colored at any time
prior to May 1, 1959, with the coal-tar color certified prior to the
enactment of this proviso as F. D. & C. Red 32, or certified after
such enactment as External D. & C. Red 14 in accordance with
section 21 Code of Federal Regulations, part 9: And provided
further, That, without regard to the requirements of sections
406 (b) and 701 (e), the Secretary shall promptly establish, and
may from time to time amend, regulations (1) prescribing the
conditions (including quantitative tolerance limitations) under
which the coal-tar color known as Citrus Red No. 2 (more particu-
larly to be defined in such regulations) may be safely used in
coloring the skins of oranges which are not intended or used for
processing (or, if so used, are oranges designated in the trade as
"packing house elimination"), and which meet minimum maturity
standards established by or under the laws of the States in which
the oranges are grown, (2) providing for separately listing such
color solely for such use on such oranges, and (3) providing for
the certification of batches of such color, with or without harmless
diluents, for such restricted use; and such oranges, if colored prior
to September 1,1961, and to the enactment by the Congress (subse-
quent to the date of enactment of this proviso) of general legisla-
tion for the listing and certification of food color additives under
safe tolerances in conformity with this proviso and such regula-
-------
964 LEGAL COMPILATION—PESTICIDES
tions, with Citrus Red No. 2 from a batch certified in accordance
with such regulations, shall not be deemed to be adulterated within
the meaning of this paragraph.]
(c) If it is, or it bears or contains, a color additive which is
unsafe within the meaning of section 706 (a).
(d) If it is confectionery, and it bears or contains any alcohol or
nonnutritive article or substance except [harmless] authorized
coloring, harmless flavoring, harmless resinous glaze not in excess
of four-tenths of 1 per centum, natural gum, and pectin: Provided,
That this paragraph shall not apply to any confectionery by
reason of its containing less than one-half of 1 per centum by
volume of alcohol derived solely from the use of flavoring extracts,
or to any chewing gum by reason of its containing harmless non-
nutritive masticatory substances.
(e) If it is oleomargarine or margarine or butter and any of the
raw material used therein consisted in whole or in part of any
filthy, putrid, or decomposed substance, or such oleomargarine or
margarine or butter is otherwise unfit for food.
[p. 38]
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
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
listing of any color additives suitable and safe for general or
restricted use in foods, drugs, or cosmetics, and for their certifica-
tion (or exemption from certification) ; and making other amend-
ments 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-
stitutent 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
-------
STATUTES AND LEGISLATIVE HISTORY 965
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.
[p. 64]
Section 102 (a)
Paragraph (1) adds color additives to the exceptions from sec-
tion 402 (a) (2) (A) of the act, which now declares adulterated any
food bearing or containing a poisonous or deleterious added sub-
stance which is unsafe within the meaning of section 406 of the
act "except a pesticide chemical in or on a raw agricultural
commodity and except a food additive." This paragraph of the bill
makes explicit, with regard to color additives, the interpretation
of the Supreme Court in Flemming v. Florida Citrus Exchange
(358 U.S. 153 (1958)), that section 406 (a) of existing law—
which authorizes the establishment of tolerances for poisonous or
deleterious substances added to food where the additive is required
in the production of the food or cannot be avoided by good manu-
facturing practice—cannot serve as a basis for allowing the use of
coal-tar colors where marketability of a food depends on such
coloring. Under the bill, section 706 of the act would (except dur-
ing a transitional period) provide the exclusive procedure for the
listing (with or without tolerance limitations) and certification
of color additives.
Paragraph (2) amends section 402 (c) to deem a food adulter-
ated if "it is, or it bears or contains," a "color additive" which is
"unsafe within the meaning of section 706(a)" of the basic act as
enacted by the bill. This would replace the present requirement of
section 402 (c) that deems adulterated a food bearing a coal-tar
color which is not from a batch certified under section 406 (b), and
the provisos to section 402 (c) with respect to the use of color on
oranges (see Public Law 86-2). (Sec. 406 (b) of the act would be
repealed under another section of the bill). The effect of these
changes would be to (a) make the new provisions applicable to all
color additives, whether or not they are coal-tar colors; (6) extend
them to the color additive itself before being added to food; and
(c) use the technique of the Pesticide Chemicals Amendment and
Food Additives Amendment by deeming the article adulterated if
the additive is "unsafe" under another section (in this case the
amended sec. 706) of the basic act which sets forth the criteria
under which the additive shall be deemed unsafe.
Paragraph (3) adds to section 403 of the basic act a new subsec-
-------
966
LEGAL COMPILATION—PESTICIDES
tion (1), whereby a food which is a color additive is deemed
[p. 69]
misbranded unless packaged and labeled in accordance with pack-
aging and labeling requirements, if any, contained in regulations
issued under section 706 (as amended by the bill). (Under the
basic act's definition of "food," a color additive intended to be
added to food is itself considered "food" before it is so added.)
Section 102(b)
Paragraph (1) amends section 501 (a) (4) of the basic act to
deem adulterated any drug containing a color additive solely for
purposes of coloring, and any color additive which (with respect
to its use in or on drugs) is intended solely for coloring purposes,
if these are unsafe within the meaning of section 706 (a) of the act.
This would replace the present provision of section 501 (a) (4),
which deems a drug adulterated if it bears or contains for purposes
of coloring only, a coal-tar color other than one from a batch that
has been certified under section 504. (Sec. 504 of the act would be
repealed by another section of the bill.)
Paragraph (2) adds to section 502 of the basic act a new sub-
section (m) deeming misbranded a drug which is a color additive
the intended use of which in or on drugs is for the purpose of
coloring only, unless its packaging and labeling are in conformity
with packaging and labeling requirements, if any, contained in
regulations issued under section 706. (A color additive is, under
the definition of "drug" in the basic act, itself a drug when intend-
ed for use as a component of drugs.)
[p. 70]
l.lOd (3) CONGRESSIONAL RECORD
l.lOd (3) (a) VOL. 105 (1959), Aug. 24: Amended and passed Sen-
ate, p. 16780
l.lOd (3) (b) VOL. 106 (1960), June 25: Discharged, amended, and
passed House, pp. 14356-14358,14373,14377
Mr. HARRIS.
*****
COLOR ADDITIVES AMENDMENTS
(H.R. 7624)
Mr. Speaker, the committee bill, H.R.
7624, was reported unanimously by the
Committee on Interstate and Foreign
Commerce. It is designed to meet a
pressing need for replacing the incon-
sistent, and in part outmoded, provi-
sions which now govern the use of
different kinds of color for articles
covered by the Federal Food, Drug,
and Cosmetic Act, with a specifically
sound and uniform system for the list-
ing of color additives of any kind
which may safely be used in foods,
drugs or cosmetics, subject, when nec-
essary, to appropriate tolerance limita-
tions 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.
-------
STATUTES AND LEGISLATIVE HISTORY
967
GENERAL SUMMARY
In brief, the committee bill, first,
takes color additives out of the scope
of the food additives amendment of
1958; second, repeals the present pro-
visions of the Federal Food, Drug, and
Cosmetic Act for the listing and certi-
fication of "harmless" coal-tar colors
(sees. 406(b), 504, and 604) ; third, en-
acts new, integrated provisions for the
separate listing of suitable color addi-
tives, safe for use in food, drugs or cos-
metics, under such conditions — in-
cluding tolerance limitations — as the
Secretary of Health, Education, and
Welfare may find necessary to assure
the safety of the uses permitted;
fourth, provides for the certification
(or exemption from certification) of
listed color additives for such per-
mitted uses; fifth, adapts the adulter-
ation and other provisions of the
Federal Food, Drug, and Cosmetic
Act to the substantive and other
changes involved in the above-men-
tioned changes; and sixth, contains
transitional provisions for commer-
cially established colors.
[p. 14356]
1. COAL-TAR COLORS
The term "coal-tar color" has been
interpreted to apply not only to sub-
stances which are coal-tar derivatives
but also to synthetic substances so re-
lated in their chemical structure to a
coal-tar constituent as to be capable of
derivation therefrom even when not
actually so derived.
So-called coal-tar colors are regu-
lated under the act through similar
sets of provisions in chapters IV Food,
V Drugs, and VI Cosmetics. The act
requires the Secretary of Health, Edu-
cation, and Welfare to provide by reg-
ulation for listing and certifying
batches of "coal-tar colors which are
harmless and suitable for use" in food,
drugs, and cosmetics.
Food containing coal-tar color is
deemed adulterated under section 402
(c) of the act unless the color is from
a batch certified by the Secretary under
section 406. Section 406 (b) then di-
rects the Secretary to provide for list-
ing 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) un-
less 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 cosmetic—other than a hair dye,
which is defined to exclude eyelash and
eyebrow dyes—containing a coal-tar
color is deemed adulterated by section
601 (e) unless the color is from a batch
certified by the Secretary under section
604. Section 604 then directs the Sec-
retary to provide for listing of coal-tar
colors that are harmless and suitable
for use in cosmetics, and for certifying
batches of such colors.
The Secretary of Health, Education,
and Welfare is without authority to
admit a coal-tar color to listing under
tolerance limitations; it must be harm-
less per se in order for the Secretary
to admit it to listing—Flemming v.
Florida Citrus Exchange (358 U.S.
153 (1958).
One exception to the prohibition
against the listing of a coal-tar color
under tolerance limitations was made
by the Congress in Public Law 86-2 to
permit the temporary listing and certi-
fication of the color citrus red No. 2
for the coloring of mature oranges
under tolerances found to be safe by
the Secretary of Health, Education,
and Welfare.
2. OTHER COLORS
A coloring material not classified as
a coal-tar color is not subject to any
pretesting, listing, or certification re-
-------
968
LEGAL COMPILATION—PESTICIDES
quirements in the case of cosmetics or
drugs except as pretesting may be re-
quired for a coloring component as an
incident to official clearance of a "new
drug" under the "new drug" provisions
of the act.
Non-coal-tar coloring materials used
in food, when such materials are not
generally recognized by experts as
safe, are classified 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 to be adul-
terated if the additive is unsafe within
the meaning of section 409. Under sec-
tion 409 the food additive is deemed
unsafe unless it and its use, or in-
tended use, conform to a regulation
issued by the Secretary announcing
the conditions, including the establish-
ment of tolerance limitations, under
which the additive may be safely used.
Food colors which were in commercial
use before January 1,1958, are allowed
a grace period not later than March 6,
1961, for compliance with the provi-
sions of the Food Additives Amend-
ment of 1958. Such "food additive"
colors, however, are not subject to any
requirement of "batch" certification.
NEED FOR LEGISLATION
The principal reasons which give
rise to the need for this legislation
may be summarized as follows:
First. The law with respect to coal-
tar colors—and this comprises most
synthetic colors—is not in consonance
with modern concepts of consumer pro-
tection, in that it does not allow the
Secretary of Health, Education, and
Welfare to list a color for safe use un-
der regulations which place a limit on
the amount of a color that may be used
on an article and to establish other
conditions of use. For food, and for
drugs and cosmetics other than those
externally applied, the Secretary must
ban the use of such a color completely,
as not being harmless, if it is found to
be toxic in the laboratory when fed to
animals in some concentrations, even
though its actual level and manner of
use may be completely safe. For exter-
nally applied drugs and cosmetics, the
same principle applies if toxicity ap-
pears in the laboratory in some con-
centrations by any relevant type of
test, even though its actual level and
manner of use may be wholly safe.
Prior to delisting proceedings by the
Department of Health, Education, and
Welfare there were 19 colors listed for
unrestricted use in food, drugs, and
cosmetics, 69 colors listed for unre-
stricted use in drugs and cosmetics,
and 30 colors listed for use only in ex-
ternally applied drugs and cosmetics,
a total of 118 straight colors listed for
certification. Seven colors have been
removed from the food, drug, and cos-
metic list and have been relisted for
external use in drugs and cosmetic
colors, so that we now have 12 food,
drug, and cosmetic colors, 69 unre-
stricted drug and cosmetic colors, and
37 drug and cosmetic colors for exter-
nal use. The Department has proposed
that other colors be removed from list-
ing and certification.
Only last week the Food and Drug
Administration announced a tentative
decision removing 14 coal-tar colors
used principally in lipsticks from the
list of permitted colors for unrestricted
use in drugs and cosmetics. This deci-
sion was based upon an evaluation of
evidence presented at a public hearing
granted color, lipstick, and drug man-
ufacturers. A final decision on delisting
will be made after consideration of any
objections which may be filed by the
affected parties to the proposed order.
The principle of allowing colors to
be used under tolerance limitations
was endorsed, in 1956, by a committee
of recognized scientists appointed by
the National Academy of Sciences to
review the coal-tar color research pro-
gram of the Food and Drug Adminis-
tration, as indicated by the following
excerpt from the committee's report:
-------
STATUTES AND LEGISLATIVE HISTORY
969
This committee feels compelled to indicate
that certification of a compound as harmless
and suitable for use in food, drugs, and cos-
metics as required under present law is un-
realistic unless the level of use is specified
(report of the National Academy of Sciences-
National Research Council Ad Hoc Advisory
Committee To Review the Food and Drug Ad-
ministration's Research Program on Coal-tar
Dyes, June 1956).
Second, The theoretically perfect
public health protection once thought
to be accorded by the present law re-
garding coal-tar colors has turned out
to be in fact inadequate. While theo-
retically, only harmless colors may be
listed, a retesting program of the Food
and Drug Administration, employing
the most modern testing techniques,
has led to the discovery that many of
the so-called coal-tar colors on the list
may in fact be toxic in some concentra-
tions. Yet, the Secretary of Health,
Education, and Welfare cannot take a
particular color off the list until he
establishes its toxicity by laboratory
tests, a process which for the list as a
whole may take as much as 20 years.
Under the bill, there would, in general,
be a maximum of 2% years during
which the retesting process for the
established colors would have to be
completed—primarily by industry—
and during which the Secretary could
establish temporary tolerance limita-
tions, at zero level if necessary, to
protect the public health. This maxi-
mum period could be extended only
where, in a particular case, such exten-
sion is necessary to complete the re-
quired safety tests for a color and is
found consistent with protection of
the public health.
Third. There is a need for making
applicable to all color uses and all
,ypes of color—whether they be coal-
er colors or others—the same pre-
testing requirements and, where nec-
assary for the protection of color
users and consumers, the same require-
ment for certification of colors to
assure their purity and identity with
;hose listed as safe. At present there
ire no provisions for the certification
of non-coal-tar colors. There is, more-
over, no pretesting requirement for
non-coal-tar additives as such, other
than food additives.
Fourth. Unless the law, as proposed
by the bill, is brought into conformity
with modern methods of control by in-
corporation of the safe-for-use princi-
ple, it will become increasingly difficult,
and may eventually become impossible,
to find permissible colors to supply the
demand for various important color
uses on the part of consumers as well
as the food, drug, and cosmetic indus-
tries. From the standpoint of the public
interest there is no compensating ad-
vantage for the inflexibility of the
present law in this respect.
The food, drug, cosmetic, and color
industries find themselves in a serious
situation as the result of the removal
of color after color from the lists under
[p. 14357]
the present inflexible provisions of the
law. Unless the law, by permitting the
listing of colors under safe tolerances,
is brought into line with present-day
methods of control, the emergency will
grow and deepen, an emergency which
the Secretary of Health, Education,
and Welfare believes could be relieved
for most established colors on a sound
and permanent basis by enacting the
provisions of this bill without in any
way conflicting with the need for ade-
quate protection of the public health.
There is no justification, from the
point of view of the public interest, in
driving either color manufacturers or
food, drug, or cosmetic producers, de-
pendent upon the use of color, out of
business where the particular use of
color involved is one which can safely
be admitted under proper conditions of
use—including tolerance limitations
and certification requirements—estab-
lished by the Department of Health,
Education, and Welfare.
The scientifically sound principle
that we must consider conditions of
use when passing on suitability and
safety of a color additive has recently
-------
970
LEGAL COMPILATION—PESTICIDES
been approved by Congress in tempor-
ary emergency legislation—Public Law
86-2—with respect to one coal-tar
color, i.e., citrus red No. 2 for use in
coloring mature oranges, after pre-
vious adoption of the "Safe-for-use"
principle in the Food Additives Amend-
ment of 1958—Public Law 85-929. In
reporting upon the emergency legis-
lation for citrus red No. 2, this com-
mittee said:
It is specifically provided that the provisions
of this bill will become inoperative on August
31, 1961, or before that time if general legis-
lation affecting coloring materials for food is
enacted by the Congress. One reason for the
time limit is that this emergency legislation,
will meet the immediate needs of the
citrus industry without permanently engrafting
on the basic Food, Drug, and Cosmetic Act a
new principle of tolerances for coal-tar colors
which is not applicable to foods generally. The
expiration date has been so fixed as to allow
the Congress ample time to consider the appli-
cation of this principle to all foods.
It is the intention of the committee as soon
as feasible to study amendments to the Federal
Food, Drug, and Cosmetic Act dealing, with
color additives generally, since the need for
such legislation has been amply demonstrated
to this committee (86th Cong., 1st sess., H.
Kept. 88).
The bill—by* permitting, for a rea-
sonable period, the provisional listing
and certification of heretofore commer-
cially established colors, under tempo-
rary tolerances where necessary for
public-health protection, pending the
development of the scientific data re-
quired for a definitive determination
as to the listing of these colors under
the permanent provisions of the bill—
would permit an orderly transition to
the control procedures of the bill. At
the same time, the bill would establish
on a permanent basis a sound system
of color regulation fully protective of
consumer interests.
EXPLANATION OF COMMITTEE BILL
The bill would change existing law
in the following major respects:
First. Uniform criteria of admissi-
bility. It would do away with the differ-
ences in legal requirements and treat-
ment as between the so-called coal-tar
colors and other color additives, and
would establish an integrated and in-
ternally consistent basis for determin-
ing the admissibility of any coloring
material for use in or on foods, drugs,
or cosmetics—other than hair dyes.
This would be accomplished by except-
ing color additives—as defined in the
bill—from the term "food additive";
repealing the present provisions for
listing and certification of coal-tar
colors; enacting, as part of a single
section—section 706—comprehensive
provisions for the separate listing of
any color additives suitable and safe
for general or restricted use in foods,
drugs, or cosmetics, and for their certi-
fication—or exemption from certifica-
tion—and making other amendments
to the act to mesh with these provisions.
The bill would embrace all color
additives whether or not synthesized
and whether or not capable of deriva-
tion 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 be-
tween so-called coal-tar colors and
other coloring substances will have the
incidental effect of establishing a pre-
testing and safety clearance require-
ment 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 was
forcefully brought to the attention of
Congress by the investigations and
recommendations of the House Select
Committee To Investigate the Use of
Chemicals in Foods and Cosmetics, the
Delaney committee in the 82nd Con-
gress, and by the hearings culminating
in the enactment of the Food Additives
Amendment of 1958.
-------
STATUTES AND LEGISLATIVE HISTORY
971
Second. Safety-of-use principle. The
bill adopts for all colors, and for all
color uses covered by it, the basic prin-
ciple of the Food Additives 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 (in-
cluding maximum tolerance limita-
tions) as are determined to be neces-
sary to assure the safety of such use.
Third. The Delaney anticancer
clause. One provision of the bill which
aroused considerable controversy in
the hearings on this legislation is pro-
posed section 706 (b) (5) (B) appearing
on page 11, line 8, of the reported bill,
and often referred to as the Delaney
anticancer clause.
This clause provides that a color
additive shall be deemed unsafe and
shall not be listed for any use which
will or may result in ingestion of all or
any part of such additive if the addi-
tive is found to induce cancer when
ingested by man or animal, or if it is
found to induce cancer in man or
animal by other tests, not involving
ingestion, which are considered to be
appropriate for the evaluation of the
safety of additives for use in food.
This clause also provides that a color
additive shall be deemed unsafe and
shall not be listed for any use which
will result in ingestion of any part of
such additive if, after tests which are
appropriate for the evaluation of the
safety of the additive for such use, or
after other relevant exposure of man
or animal to such additive, it is found
by the Secretary to induce cancer in
man or animal.
A similar anticancer clause is in-
cluded in the Food Additives Amend-
ment of 1958 to the Federal Food,
Drug, and Cosmetic Act—Public Law
85-929.
There are many unknowns about
cancer that are yet to be solved. We do
know, however, that today cancer is
second only to heart disease as a cause
of death among the American people.
Every year, approximately 250,000
people die of cancer in this country.
Approximately 450,000 new cases of
cancer are discovered each year. At
any given time about 700,000 persons
are under treatment for cancer.
Expert testimony before the com-
mittee showed that scientific inquiry
into the incidence of cancer among
certain occupational groups has been
traced, in several instances, to specific
substances involved in their environ-
ment. Laboratory experiments have
1 shown that a number of substances
when added to the diet of test animals
have produced cancers of various kinds
in the test animals. It is this fact—
namely, that small quantities of cer-
tain materials over a period of time
will cause abnormal cell growth in
animals—that gave rise to the Delaney
anticancer clause in the Food Addi-
tives Amendment.
[p. 14358]
Mr. HARRIS. Mr. Speaker, I ask
unanimous consent for the immediate
consideration of 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 suit-
able color additives in or on foods,
drugs, and cosmetics, in accordance
with regulations prescribing the con-
ditions — including maximum toler-
ances—under which such additives
may be safely used.
The Clerk read the title of the bill.
The SPEAKER pro tempore. Is
there objection to the request of the
gentleman from Arkansas?
There was no objection.
The Clerk read the bill, as follows:
Be it enacted by the Senate and House of
Representatives of the United States of America
in Congress assembled. That this act may be
cited as the "Color Additive Amendments of
1959."
-------
972
LEGAL COMPILATION—PESTICIDES
Colors or colored articles—when deemed to be
adulterated or misbranded foods, drugs,
or cosmetics
Food
SEC. 102. (a)(l) Clause <2)(A) of section
402(a), as amended, of such act (relating to
food deemed adulterated by reason of unsafe
additives) is further amended by striking out
the matter within the parentheses and inserting
in lieu thereof the following: "other than one
which is (i) a pesticide chemical in or on a raw
agricultural commodity; (ii) a food additive;
or (iii) a color additive".
(2) Section 402(c), as amended, of such act
(relating to food deemed adulterated by reason
of uncertified coal-tar color) is amended to
read as follows:
"(c) If it is, or it bears or contains, a color
additive which is unsafe within the meaning
of section 706(a)." [p. 14373]
"Changes in cross-references and
terminology
'SEC. 105. Such Act is further amended by—
"(a) striking out, in section 301 (i) thereof
(relating to forgery 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)(l) striking out, in clause (3) of section
303(c) (relating to color manufacturer's guar-
antee), 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 "additive*; and
"(c) striking out 'harmless coloring' in sec-
tion 402 (d) (relating to nonnutritive sub-
stances in confectionery) and inserting in lieu
thereof 'authorized coloring'.
[p. 14377]
l.lOd (3) (c) VOL. 106 (1960), June 30: Senate concurs in House
amendment, p. 15133
[No Relevant Discussion on Pertinent Section]
1.10e ANIMAL DRUGS IN FEEDS AMENDMENTS OF 1968
July 13,1968, P.L. 90-399, §104, 82 Stat. 352
ANIMAL DRUGS IN FEEDS AND RESIDUES THEREOF IN OTHER FOOD
SEC. 104. Section 402 of the Federal Food, Drug, and Cosmetic
Act, as amended, is amended by—
(1) striking out the word "or" before " (iii)" in clause (A)
of sub paragraph (2) of paragraph (a) and inserting "; or
(iv) a new animal drug" after the words "color additive"
therein; and
(2) adding before the semicolon following "commodity" at
the end of the proviso clause (C) of subparagraph (2) of
paragraph (a) the following: "; or (D) if it is, or it bears or
contains, a new animal drug (or conversion product thereof)
which is unsafe within the meaning of section 512".
[p. 352]
-------
STATUTES AND LEGISLATIVE HISTORY 973
l.lOe (1) HOUSE COMMITTEE ON INTERSTATE AND
FOREIGN COMMERCE
H.R. REP. No. 875, 90th Cong., 1st Sess. (1967)
ANIMAL DRUG AMENDMENTS OF 1967
OCTOBER 31, 1967.—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. 3639]
The Committee on Interstate and Foreign Commerce, to whom
was referred the bill (H.R. 3639) to protect the public health by
amending the Federal Food, Drug, and Cosmetic Act to consolidate
certain provisions assuring the safety and effectiveness of new
animal 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 as follows:
On page 28, strike out lines 9 through 16.
On page 28, line 19, strike out "107" and insert in lieu thereof
"106".
On page 29, line 4, strike out "108" and insert in lieu thereof
"107".
PRINCIPAL PURPOSE OF THE BILL
The bill would consolidate into one place in the law all of the
principal provisions of the Federal Food, Drug, and Cosmetic Act
which relate to premarketing clearance of new drugs for admin-
istration to animals, either directly or in their feed and water. The
bill is supported by the entire animal drug and feed manufacturing
industry, by the Department of Health, Education, and Welfare,
the Bureau of the Budget, and the Department of Agriculture.
[p.l]
*******
SECTIONS 104-105
These sections make changes in section 402 (adulterated food) ;
502 (misbranded drugs) ; and 507 (antibiotics) to reflect the new
pattern of regulation of new animal drugs and animal feeds by
the new section 512. r
[p. 6]
-------
974 LEGAL COMPILATION—PESTICIDES
CHAPTER IV—FOOD
*******
ADULTERATED FOOD
SEC. 402. A food shall be deemed to be adulterated—
(a) (1) If it bears or contains any poisonous or deleterious
substance which may render it injurious to health; but in case the
substance is not an added substance such food shall not be con-
sidered adulterated under this clause if the quantity of such
substance in such food does not ordinarily render it injurious to
health; or
[p. 17]
(2) (A) if it bears or contains any added poisonous or added dele-
terious substance (other than one which is (i) a pesticide chemical
in or on a raw agricultural commodity; (ii) a food additive; [or]
(iii) a color additive; or (iv) a new animal drug) which is unsafe
within the meaning of section 406, or (B) if it is a raw agricultur-
al commodity and it bears or contains a pesticide chemical which is
unsafe within the meaning of section 408 (a) ; or (C) if it is, or it
bears or contains, any food additive which is unsafe within the
meaning of section 409; Provided, That where a pesticide chemical
has been used in or on a raw agricultural commodity in conformity
with an exemption granted or a tolerance prescribed under section
408 and such raw agricultural commodity has been subjected to
processing such as canning, cooking, freezing, dehydrating, or
milling, the residue of such pesticide chemical remaining in or on
such processed food shall, notwithstanding the provisions of sec-
tions 406 and 409, not be deemed unsafe if such residue in or on
the raw agricultural commodity has been removed to the extent
possible in good manufacturing practice and the concentration of
such residue in the processed food when ready to eat is not greater
than the tolerance prescribed for the raw agricultural commodity;
or (D) if it is, or it bears or contains, a new animal drug (or con-
version product thereof) which is unsafe within the meaning of
section 512; or
(3) if it consists in whole or in part of any filthy, putrid, or
decomposed substance, or if it is otherwise unfit for food; or (4) if
it has been prepared, packed, or held under insanitary conditions
whereby it may have become contaminated with filth, or whereby it
may have been rendered injurious to health; or (5) if it is, in
whole or in part, the product of a diseased animal or of an animal
which has died otherwise than by slaughter; or (6) if its container
is composed, in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health; or
-------
STATUTES AND LEGISLATIVE HISTORY 975
(7) if it has been intentionally subjected to radiation, unless the
use of the radiation was in conformity with a regulation or exemp-
tion in effect pursuant to section 409.
(b) (1) If any valuable constituent has been in whole or in part
omitted or abstracted therefrom; or (2) if any substance has been
substituted wholly or in part therefor; or (3) if damage or inferi-
ority has been concealed in any manner; or (4) if any substance
has been added thereto or mixed or packed therewith so as to
increase its bulk or weight, or reduce its quality or strength, or
make it appear better or of greater value than it is.
(c) If it is, or it bears or contains, a color additive which is
unsafe within the meaning of section 706 (a).
(d) If it is confectionery, and—
(1) has partially or completely imbedded therein any non-
nutritive object: Provided, That this clause shall not apply in
the case of any nonnutritive object if, in the judgment of the
Secretary as provided by regulations, such object is of prac-
tical functional value to the confectionery product and would
not render the product injurious or hazardous to health;
(2) bears or contains any alcohol other than alcohol not in
excess of one-half of 1 per centum by volume derived solely
from the use of flavoring extracts; or
(3) bears or contains any nonnutritive substance: Pro-
vided, That this clause shall not apply to a safe nonnutritive
[p. 18]
substance which is in or on confectionery by reason of its use
for some practical functional purpose in the manufacture,
packaging, or storage of such confectionery if the use of the
substance does not promote deception of the consumer or
otherwise result in adulteration or misbranding in violation
of any provision of this Act: And provided further, That the
Secretary may, for the purpose of avoiding or resolving
uncertainty as to the application of this clause, issue regula-
tions allowing or prohibiting the use of particular nonnutri-
tive substances.
(e) If it is oleomargarine or margarine or butter and any of
the raw material used therein consisted in whole or in part of any
filthy, putrid, or decomposed substance, or such oleomargarine or
margarine or butter is otherwise unfit for food.
[p. 19]
-------
976 LEGAL COMPILATION—PESTICIDES
l.lOe (2) SENATE COMMITTEE ON LABOR AND PUBLIC
WELFARE
S. REP. No. 1308, 90th Cong., 2d Sess. (1968)
ANIMAL DRUG AMENDMENTS OF 1968
JUNE 21 (legislative day, JUNE 19), 1968.—Ordered to be printed
Mr, HILL, from the Committee on Labor and Public Welfare,
submitted the following
REPORT
[To accompany H.R. 3639]
The Committee on Labor and Public Welfare, to which was
referred the bill (H.R. 3639) to protect the public health by amend-
ing the Federal Food, Drug, and Cosmetic Act to consolidate
certain provisions assuring the safety and effectiveness of new
animal drugs, and for other purposes, having considered the same,
reports favorably thereon with amendments and recommends that
the bill as amended do pass.
PRINCIPAL PURPOSE OF THE BILL
The bill would consolidate into one place in the law all of the
principal provisions of the Federal Food, Drug, and Cosmetic Act
which relate to premarketing clearance of new drugs for admin-
istration to animals, either directly or in their feed and water.
The bill is supported by the entire animal drug and feed manu-
facturing industry, by the Department of Health, Education, anc
Welfare, the Bureau of the Budget, and the Department of Agri-
culture.
The enactment of this legislation would merely consolidate pro-
visions under existing law and would in no way weaken th<
authorities of the Food and Drug Administration with respect tc
the regulation of new animal drugs.
NEED FOR LEGISLATION
In many cases, the requirements for clearance of new drugs fo
administration to animals are more complicated than the clearance
procedures for new human drugs. These complexities have in somi
[P.I:
instances led to long delays in the clearance of new animal drugs
and the purpose of the bill is to provide a single procedure fo
clearance of these drugs.
-------
STATUTES AND LEGISLATIVE HISTORY 977
Under existing law, a drug which is intended for use in animal
feeds is regulated both as a new drug under section 505 of the
Federal Food, Drug, and Cosmetic Act, and as a food additive
under section 409 of that act. This means that the drug must be
cleared under the procedures of both sections of the law. Where
the product is a combination of drugs containing a certifiable
antibiotic, the product is regulated under the antibiotic section of
the Federal Food, Drug, and Cosmetic Act (sec. 507).
By consolidating into one place in the law all of the provisions
providing for regulation of these drugs, clearances should be expe-
dited, with resulting decreases in costs, and consequent encour-
agement for the development by manufacturers of new drugs for
use in animals.
USE OP ANIMAL DRUGS
In the past 15 years the animal feed industry in the United
States has been virtually revolutionized through the use of drugs
and other additives in the feed of animals. Drugs are used to pro-
mote growth and combat disease, and as a result of the increasing
use, animals today add more meat per pound of feed in a much
shorter time than has ever been true in the past. This means that
the price of meat and poultry is much less than it otherwise would
be. For example, in 1950 broiler production was about 630 million
birds whereas in 1965 it was well over 2 billion. The average retail
price of broilers has dropped from 57 cents a pound in 1950 to
approximately 39 cents today. This results from two factors. First,
a few years ago, broiler producers had 15 to 20 percent of their
chicks die before they reached maturity whereas today it is not
unusual for broiler producers to raise 99 to 100 percent of the
chicks started.
In addition, broilers are ready for market weeks earlier today
than a few years ago, and they consume less feed per pound of
added body weight than was true a few years ago. Similar devel-
opments have taken place in the beef producing industry and in
the production of swine, lambs, and other animals.
The American consumer, it is widely acknowledged, is the best
fed in the world. He is so in very large part because the animal
health industry has provided the farmer with the resources to
maintain and enlarge herds and flocks of meat- and milk-producing
animals. Yet the farmer even today suffers enormous losses in
disease, parasites, and insects, losses estimated by the Department
of Agriculture at $2.8 billion per year. These losses not only
reduce farm income, but by reducing the supply of food, affect the
-------
978 LEGAL COMPILATION—PESTICIDES
availability of meat, poultry, eggs, and milk and increase the cost
of the basic foods to the consumer.
Each delay in the clearance of safe and effective products for
animal health perpetuates these losses. Every duplication of unnec-
essary controls adds to the ultimate cost of providing food for the
consumer. Every lack of administrative coordination adds need-
lessly to the time required to provide the farmer with the resources
he needs to feed an ever-growing population.
[p. 2]
At the hearing held on H.R. 3639 and in similar hearings held on
earlier proposals, there was ample testimony that the existing
provisions of the Federal Food, Drug, and Cosmetic Act, because
they were designed primarily to be applicable to drugs and food
additives for human consumption, created problems in the admin-
istration of the act with respect to animal health products. Some of
the delay and lack of coordination has been cured administratively
by the Food and Drug Administration. On the basis of hearings,
however, it seems quite apparent that this coordination should be
fostered legislatively by consolidating into one section of the act,
in a coordinated fashion, under a simplified procedure, the various
provisions and requirements applicable to animal-health products.
H.R. 3639, as reported by the committee, is intended to do just
this: Coordinate and consolidate the applicable provisions govern-
ing drugs, feed additives, and antibiotics for animal use into one
logical coordinated system that, without removing any of the
stringent requirements for premarketing clearances, would assist
this clearance and the subsequent use of animal-health products.
This bill draws a distinction between new animal drugs and
animal feed bearing or containing a new animal drug, and subjects
them to different regulations and procedures.
Section 102 of this bill, which amends section 201 of the Federal
Food, Drug, and Cosmetic Act, in effect defines the term "new
animal drug," as used in the bill, as including any "new drug"
intended for use in animal feed but not including such animal feed.
"Animal feed" is defined as "an article which is intended for use
for food for animals other than man and which is intended for use
as a substantial source of nutrients in the diet of the animal, and
is not limited to a mixture intended to be the sole ration of the
animal." Thus, under this legislation, the term "animal feed"
encompasses all categories of animal feed intended for use as a
substantial source of nutrients in the diet of the animal, including
complete feed, feed additive supplements, and feed additive con-
centrates, as distinguished from so-called feed additive premixes.
An animal feed bearing or containing a new animal drug will be
-------
STATUTES AND LEGISLATIVE HISTORY 979
subject to the provisions of proposed new section 512 (m) as
contained in this bill. On the other hand, a feed additive "premix"
—which is defined by present regulations (21 CFR 121.200) as an
article that must be diluted in a ratio of 1 to 100 pounds per ton
for safe use in a feed additive concentrate or supplement or in a
complete feed—is, if it contains a new animal drug, itself classifi-
able as a "new animal drug" under the bill as distinguished from
an "animal feed." Such a premix is subject to the provisions of
proposed new section 512 (b) as embodied in this bill.
AMENDMENT
As passed by the House of Representatives, H.R. 3639 would
have permitted the export of new animal drugs, or animal feeds
bearing or containing new animal drugs, determined to be unsafe
within the meaning of the proposed section 512 of the Federal
Food, Drug, and Cosmetic Act. At the request of the Department of
Health, Education, and Welfare, this committee has adopted an
amendment to section 801 (d) of the act that would prevent the
export of such animal drugs and such animal feeds. r „,
Lp. oj
Under existing law, new animal drugs may not be exported to
foreign countries unless the drugs comply fully with the require-
ments of the U.S. law.
The purpose of the committee amendment is to preserve, essen-
tially, the status quo with respect to the export exemption. Except
for an extremely narrow category of antibotics that are intended
for direct administration to animals and have not been exempted
from the batch-by-batch certification requirement of the present
act (sec. 507), all the drugs which under the bill would be known
as new animal drugs, and also all animal feeds medicated there-
with, at present fall within the definition of "new drugs" and as
such are not within the scope of the export exemption (sec. 801
(d)) of the Food and Drug Act and must meet domestic standards
insofar as these apply. (It should be noted in this connection that,
under the terms of the bill, the requirement of the bill that the
manufacturer or distributor of a new animal drug for use in the
manufacture of feed obtain from the consignee of the drug a
statement that he is, or will ship only to, the holder of an approved
animal feed application applies only if the drug is for use in the
manufacture of feed in a State, and hence does not apply to exports
of these drugs for use in feed manufacture in foreign countries.)
HEARINGS
Hearings on H.R. 3639 were held on May 24, 1968, by the Sub-
committee on Health of the Labor and Public Welfare Committee.
-------
980 LEGAL COMPILATION—PESTICIDES
The Department of Health, Education, and Welfare recommended
enactment of the legislation with the amendment relating to the
export of new animal drugs adopted by the committee. The enact-
ment of H.R, 3639 was also endorsed by the Animal Health Insti-
tute, the Animal Veterinary Medical Association, and the Ameri-
can Feed Manufacturers Association.
The cost
The Department of Health, Education, and Welfare advises
this committee that the enactment of H.R. 3639 would entail no
additional cost for its administration.
SECTION- BY-SECTION ANALYSIS
The first section of the bill contains a short title.
[p. 4]
Sections 104-105
These sections make changes in sections 402 (adulterated food) ;
502 (misbranded drugs) ; and 507 (antibiotics) to reflect the new
pattern of regulation of new animal drugs and animal feeds by
the new section 512.
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
[p. 6]
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,
AS AMENDED
CHAPTER I—SHORT TITLE
SECTION 1. This Act may be cited as the Federal Food, Drug, and
Cosmetic Act.
[p. 7]
SEC. 201.
*******
(w) The term "new animal drug" means any drug intended for
use for animals other than man, including any drug intended for
use in animal feed but not including such animal feed—
(1) the composition of which is such that such drug is not
generally recognized, among experts qualified by scientific
training and experience to evaluate the safety and effective-
-------
STATUTES AND LEGISLATIVE HISTORY 981
ness of animal drugs, as safe and effective for use under the
conditions prescribed, recommended, or suggested in the label-
ing thereof; except that such a drug not so recognized shall
not be deemed to be a "new animal drug" if at any time prior
to June 25, 1938, it was subject to the Food and Drug Act of
June 25, 1906, as amended, and if at such time its labeling
contained the same representations concerning the conditions
of its use; or
(2) the composition of which is such that such drug, as a
result of investigations to determine its safety and effective-
ness for use under such conditions, has become so recognized
but which has not, otherwise than in such investigations, been
used to a material extent or for a material time under such
conditions; or
(3) which drug is composed wholly or partly of any kind of
penicillin, streptomycin, chlortetracycline, chloramphenicol,
or bacitracin, or any derivative thereof, except when there
is in effect a published order of the Secretary declaring such
drug not to be a new animal drug on the grounds that (A) the
requirement of certification of batches of such drug, as pro-
vided for in section 512(n), is not necessary to insure that the
objectives specified in paragraph (3) thereof are achieved and
(B) that neither subparagraph (1) nor (2) of this paragraph
(w) applies to such drug.
(x) The term "animal feed", as used in paragraph (w) of this
section, in section 512, and in provisions of this Act referring to
such paragraph or section, means an article which is intended for
use for food for animals other than man and which is intended for
use as a substantial source of nutrients in the diet of the animal,
and is not limited to a mixture intended to be the sole ration of the
animal.
[p. 8]
CHAPTER IV—FOOD
DEFINITIONS AND STANDARDS FOR FOOD
ADULTERATED FOOD
SEC. 402. A food shall be deemed to be adulterated—
(a) (1) If it bears or contains any poisonous or deleterious sub-
stance which may render it injurious to health; but in case the
substance is not an added substance such food shall not be con-
-------
982
LEGAL COMPILATION—PESTICIDES
sidered adulterated under this clause if the quantity of such sub-
stance in such food does not ordinarily render it injurious to
health; or
(2) (A) if it bears or contains any added poisonous or added
deleterious substance other than one which is (i) a pesticide
chemical in or on a raw agricultural commodity; (ii) a food addi-
tive ; [or] (iii) a color additive; or (iv) a new animal drug) which
is unsafe within the meaning of section 406, or (B) if it is a raw
agricultural commodity and it bears or contains a pesticide chemi-
cal which is unsafe within the meaning of section 408 (a) ; or (C)
if it is, or it bears or contains, any food additive which is unsafe
within the meaning of section 409; Provided, That where a pesticide
chemical has been used in or on a raw agricultural commodity in
conformity with an exemption granted or a tolerance prescribed
under section 408 and such raw agricultural commodity has been
subjected to processing such as canning, cooking, freezing, dehy-
drating, or milling, the residue of such pesticide chemical remain-
ing in or on such processed food shall, notwithstanding the provi-
sions of sections 406 and 409, not be deemed unsafe if such residue
in or on the raw agricultural commodity has been removed to the
extent possible in good manufacturing practice and the concentra-
tion of such residue in the processed food when ready to eat is not
greater than the tolerance prescribed for the raw agricultural com-
[p. 9]
modity; or (D) if it is, or it bears or contains, a new animal drug
(or conversion product thereof) which is unsafe within the mean-
ing of section 512; or
[p. 10]
l.lOe (3) CONGRESSIONAL RECORD
l.lOe (3) (a) VOL. 113 (1967), Nov. 6: Amended and passed House,
p. 31291
Mr. STAGGERS. Mr. Speaker, this
bill will assemble into one place in the
law all of the major provisions of the
Food and Drug Act which relate to
drugs for administration to animals
either directly or in their feed and
water.
Its principal benefits to the drug
and feed industry will be to provide
for regulation of these drugs through
legislation separate from legislation
related to human drugs so that in the
event of future legislation increasing
controls over human drugs, these in-
creased controls will not automatically
apply to animal drugs as would be the
case under existing law.
EXISTING LAW
The definition of "drug" in existing
law is very broad and covers every
substance which is intended to affect
the structure or functions of the body
of man or any other animal and, there-
-------
STATUTES AND LEGISLATIVE HISTORY
983
fore, includes not only all substances
for direct administration to animals
to promote health, but also includes all
feeds which contain drugs. This makes
every feed manufacturer in the United
States who mixes any drugs into his
product automatically a "drug manu-
facturer" subject to stringent regu-
lation.
Similarly, the term "food additive"
is very broadly defined in the Food and
Drug Act, so that drugs which are used
in the manufacture of animal feed are
also "food additives" as defined.
The result of the foregoing means
that every manufacturer of drugs for
use in animal feeds and every feed
manufacturer who uses such drugs is
subject to regulation under the Food
Additives Amendment—section 409 of
the Food and Drug Act—and the new
drug section of the law—section 505
of the Food and Drug Act.
Since a substantial number of ani-
l.lOe (3) (b) VOL. 114 (1968),
Senate, p. 18424
[No Relevant Discussion on Pertinent Section]
l.lOe (3) (c) VOL. 114 (1968), July 2: House concurs in Senate
amendments, pp. 19713-19714
AMENDING THE FEDERAL FOOD,
DRUG, AND COSMETIC ACT TO
CONSOLIDATE CERTAIN
PROVISIONS ASSURING SAFETY
AND EFFECTIVENESS OF NEW
ANIMAL DRUGS
Mr. STAGGERS. Mr. Speaker, I
ask unanimous consent to take from
the Speaker's desk the bill (H.R. 3639)
to protect the public health by amend-
ing the Federal Food, Drug and Cos-
metic Act to consolidate certain pro-
visions assuring the safety and effec-
tiveness of new animal drugs, 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:
mal feeds also contain antibiotics, feed
manufacturers are subject to regula-
tions under the antibiotic section of
the Food and Drug Act—section 507—
with respect to certified antibiotics.
A number of years ago, the manu-
facturers involved were required to
submit two separate applications to
FDA for clearance of animal feeds
containing any drug. Through adminis-
trative action, FDA has simplified the
procedure so that only one application
is required to be filed today and there
is better coordination between the three
divisions of FDA which pass on appli-
cations for the use of drugs in animal
feeds—the Food Additive Division, the
New Drug Division, and the Antibi-
otic Division.
A Bureau of Veterinary Medicine
has been established and the very sub-
stantial delays in FDA action which
formerly plagued the industry have
been cut down considerably.
[p. 31291]
June 24: Amended and passed
Page 1, line 4, strike out "1967.' " and insert
"1968.' "
Page 28. after line 8, insert:
"ANIMAL DRUGS FOB EXPORT
"SEC. 106. Section 801 (d) of the Federal Food,
Drug, and Cosmetic Act, as amended, is amended
by adding at the end thereof the following:
'Nothing in this subsection shall authorize the
exportation of any new animal drug, or an ani-
mal feed bearing or containing a new animal
drug, which is unsafe within the meaning of
section 512 of this Act.' "
Page 28, line 11, strike out "106." and insert
"107."
Page 28, line 21, strike out "107." and insert
"108."
The SPEAKER. Is there objection
to the request of the gentleman from
West Virginia?
Mr. SPRINGER. Mr. Speaker, re-
serving the right to object—and I shall
not object—I think there ought to be
some brief explanation.
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984
LEGAL COMPILATION—PESTICIDES
Mr. STAGGERS. Mr. Speaker, this
motion to concur in the Senate amend-
ment has been cleared with the gentle-
man from Illinois [Mr. SPRINGER] and
with the ranking members of the Sub-
committee on Public Health and Wel-
fare.
The amendment 0f the Senate mere-
ly restores the bill to the same status
it had when originally introduced in
the House. During the consideration of
the bill by our Subcommittee on Public
Health and Welfare, an amendment
was suggested providing some loosen-
ing of the requirements of the Food
and Drug Act with respect to exports
[p. 19713]
of animal feeds. When the bill was
considered in the Senate, this was the
only controversial feature of it, so the
Senate agreed to an amendment which
leaves existing law with respect to ex-
ports exactly the way it is today.
In other words, Mr. Speaker, this bill
is primarily a consolidation of existing
law relating to animal drugs and ani-
mal feeds bearing or containing new
animal drugs. The Senate amendment
leaves existing law as it currently
stands.
Section 106 which amends section
801 (d) of the act will in no way pre-
clude export of animal feed containing
a new animal drug which has been pro-
duced by a feed manufacturer in ac-
cordance with section 512 (m) of the
act, since its safety will have already
been determined. The Senate report
makes it clear—page 3—that animal
feed which contains a new animal drug
is to be distinguished from a new ani-
mal drug and is to be regulated under
the provisions of section 512 (m). The
second sentence of section 512 (a) (1)
which makes reference to a consignee
having an approved application applies
only to new animal drugs and has no
applicability to animal feed contain-
ing a new animal drug which has been
incorporated into the feed in accord-
ance with the provisions of section
512 (m).
Mr. Speaker, I urge the adoption of
the amendment.
Mr. SPRINGER. Mr. Speaker, I
withdraw my reservation of objection.
Mr. NELSEN. Mr. Speaker, I ask
unanimous consent to extend my re-
marks at this point in the RECORD.
The SPEAKER. Is there objection
to the request of the gentleman from
Minnesota?
There was no objection.
Mr. NELSEN. Mr. Speaker, all of us
who worked so hard and long on this
proposal to facilitate the handling of
animal drug applications by the FDS
are indeed very happy to see this bill
finally passed by the Congress.
I might comment on some clarifying
language which appears in the Senate
report. Section 106 which amends sec-
tion 801 (d) of the act will in no way
preclude the export of animal feed con-
taining a new animal drug which has
been produced by a feed manufacturer
in accordance with section 512 (m) ol
the act, since its safety will have al-
ready been determined. The Senate re-
port makes it clear—page 3—that ani-
mal feed which contains a new anima
drug is to be distinguished from a nevi
animal drug and is to be regulated un-
der the provisions of section 512 (m)
The second sentence of section 512 (a'
(1) which makes reference to a con
signee having an approved applicatioj
applies only to new animal drugs an<
has no applicability to animal feei
containing a new animal drug whic
has been incorporated into the feed i)
accordance with the provisions of sec
tion 512(m).
The SPEAKER. Is there objectioi
to the request of the gentleman fror
West Virginia?
There was no objection.
The Senate amendments were cor
curred in.
A motion to reconsider was laid o
the table.
[p. 19714
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STATUTES AND LEGISLATIVE HISTORY 985
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)]
LISTING AND CERTIFICATION OF COLOR ADDITIVES
FOR FOODS, DRUGS, AND COSMETICS—UNSAFE
COLOR ADDITIVES
21 § 376
/k) **********
/g\ **********
(D) The advisory committee referred to in subparagraph (C)
of this paragraph shall be composed of experts selected by the
National Academy of Sciences, qualified in the subject matter re-
ferred to the committee and of adequately diversified professional
background, except that in the event of the inability or refusal of
the National Academy of Sciences to act, the Secretary shall select
the members of the committee. The size of the committee shall be
determined by the Secretary. Members of any advisory committee
established under this chapter, while attending conferences or
meetings of their committees or otherwise serving at the request
of the Secretary, shall be entitled to receive compensation at rates
to be fixed by the Secretary but at rates not exceeding the daily
equivalent of the rate specified at the time of such service for
grade GS-18 of the General Schedule, including traveltime; and
while away from their homes or regular places of business they
may be allowed travel expenses, including per diem in lieu of sub-
sistence, as authorized by section 5703 (b) of Title 5 for persons
in the Government service employed intermittently. The members
shall not be subject to any other provisions of law regarding the
appointment and compensation of employees of the United States.
The Secretary shall furnish the committee with adequate clerical
and other assistance, and shall by rules and regulations prescribe
the procedure to be followed by the committee.
June 25, 1938, c. 675, § 706, 52 Stat. 1058; July 12, 1960, Pub.L.
86-618, Title I, § 103(b), 74 Stat. 399; and amended Oct. 10, 1962,
Pub.L. 87-781, Title I, § 104 (f) (2), 76 Stat. 785; Oct. 30, 1970,
Pub.L. 91-515, Title VI, § 601 (d) (2), 84 Stat. 1311.
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
SEC. 104 (f) (2) Subparagraph (B) of paragraph (5) of sec-
tion 706 (b) of such Act (21 U.S.C. 376 (b)) is amended by insert-
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986 LEGAL COMPILATION—PESTICIDES
ing before the period at the end of the subparagraph a colon and
the following proviso: "Provided, That clause (i) of this subpara-
graph (B) shall not apply with respect to the use of a color additive
as an ingredient of feed for animals which are raised for food pro-
duction, if the Secretary finds that, under the conditions of use and
feeding specified in proposed labeling and reasonably certain to be
followed in practice, such additive will not adversely affect the
animals for which such feed is intended, and that no residue of the
additive will be found (by methods of examination prescribed or
approved by the Secretary by regulations, which regulations shall
not be subject to subsection (d)) in any edible portion of such ani-
mals after slaughter or in any food yielded by or derived from the
living animal".
l.lla (1) SENATE COMMITTEE ON THE JUDICIARY
S. REP. No. 1744, 87th Cong., 2d Sess. (1962)
DRUG INDUSTRY ACT OF 1962
JULY 19,1962.—Ordered to be printed
Mr. EASTLAND, from the Committee on the Judiciary, submitted
the following
REPORT
together with
INDIVIDUAL VIEWS
[To accompany S. 1552]
The Committee on the Judiciary, to which was referred the bill
(S. 1552) to amend and supplement the antitrust laws with re-
spect to the manufacture and distribution of drugs, and for other
purposes, having considered the same, reports favorably thereon,
with an amendment in the nature of a substitute, and recommends
that the bill, as amended, do pass.
AMENDMENT
Strike all after the enacting clause and insert in lieu thereof the
following:
That the Act may be cited as the "Drug Industry Act of 1962".
[P.I]
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STATUTES AND LEGISLATIVE HISTORY 987
PURPOSE
The purpose of the proposed legislation, as amended, is to
strengthen and broaden existing laws in the drug field so as to bring
about better, safer medicine and to establish a more effective sys-
tem of enforcement of the drug laws.
The amended bill would help assure a safer and more reliable
drug supply for the Nation by requiring registration of all pre-
scription drug manufacturers and more effective inspection of their
plants to determine whether such drugs are being manufactured in
accordance with the law. In addition, the bill requires the installa-
tion and maintenance of acceptable drug manufacturing and con-
trol procedures and a premarketing showing that all new drugs are
effective—as well as safe—for their intended uses. The bill also
would improve the procedures employed in the advance approval
of new drugs and would permit the prompt removal from the mar-
ket of such drugs when new evidence, considered with what was
known originally establishes that the drug should not have been
cleared for safety in the first instance. The bill would further
require drug manufacturers to keep records and report to the
Department of Health, Education, and Welfare any indications
of adverse effects from a new drug or antibiotic and provide for the
advance testing and certification as to both safety and effectiveness
of all antibiotics—not just the few now covered by such proce-
dures. The bill includes basic improvements, in terms of simplifi-
cation and usefulness, of drug nomenclature to eliminate confu-
sion as to the identity and composition of drugs. Finally, the bill
makes provision for information on drugs to be more readily avail-
able to physicians and the general public. In short, the purpose of
this bill, as amended, is to strengthen the laws designed to keep
unfit drugs off the market in the first instance and speed their
removal should they reach the market.
[p. 8]
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988 LEGAL COMPILATION—PESTICIDES
l.lla (2) HOUSE COMMITTEE ON INTERSTATE AND
FOREIGN COMMERCE
H.R. REP. No. 2464, 87th Cong., 2d Sess. (1962)
DRUG AMENDMENTS OF 1962
SEPTEMBER 22,1962.—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. 11581]
The Committee on Interstate and Foreign Commerce, to whom
was referred the bill (H.R. 11581) to protect the public health by
amending the Federal Food, Drug, and Cosmetic Act to assure the
safety, efficacy, and reliability of drugs, authorize standardization
of drug names, establish special controls for barbiturate and stimu-
lant drugs, and clarify and strengthen existing inspection author-
ity with respect to any articles subject to the act; and to amend
related laws, having considered the same, report favorably there-
on with amendments and recommend that the bill as amended do
pass.
The amendments are as follows:
The amendment to the text strikes out all of the bill after the
enacting clause and inserts in lieu thereof a substitute which
appears in the reported bill in italic type. The substitute text is
also printed in appendix C.
The other amendment modifies the title of the bill to make it
conform to the changes made by the amendment to the text.
PURPOSE OF LEGISLATION
It is the principal purpose of the legislation better to protect the
public health by imposing additional requirements and improving
procedures in connection with—
1. Controls of manufacture of drugs to assure that manu-
facturing methods are in conformity with current good manu-
facturing practice;
2. Requirement that new drugs be shown to be effective as
well as safe;
3. Keeping of records and furnishing of reports in connec-
tion with safety and effectiveness of new drugs and antibiotics;
[p.l]
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STATUTES AND LEGISLATIVE HISTORY 989
4. Procedures to be followed in the testing of investigation-
al drugs, including patients' consent;
5. Agency procedures to be followed in approving new
drugs;
6. Summary suspension of new drugs where there is an
imminent hazard to public health;
7. Withdrawal of new drugs when their safety or effective-
ness is no longer assured;
8. Certification of all antibiotics for man (present law
requires only certification of certain antibiotics) ;
9. Factory inspection of establishments manufacturing
prescription drugs;
10. Manufacturers making available adequate information
concerning safety and effectiveness of drugs advertised to
physicians.
11. Simplifying drug nomenclature.
ADEQUATE MANUFACTURING CONTROLS FOR ALL DRUGS
The manufacturing of drugs is a business that requires highly
qualified and trained personnel, and special laboratory and other
facilities and most careful internal manufacturing, packaging, and
labeling controls. These requirements are necessary to the assur-
ance that the drugs will be safe for the user and will have, and so
far as possible retain, the identity, strength, quality, purity, and
effectiveness that they purport to have.
Except in the case of those drugs for which the Federal Food,
Drug, and Cosmetic Act requires premarketing clearance (i.e., new
drugs, certain antibiotics, and insulin) and except for drugs pre-
pared or held under insanitary conditions, nothing can be done
under the present act if these essential requirements demanded by
good manufacturing practice are not met, until a particular ship-
ment of drugs is marketed and the Food and Drug Administration
can prove that the drug itself is different. This is not adequate
assurance of consumer protection. People with inadequate expe-
rience, equipment, and technical competence can, and do, enter the
business of making drugs.
Section 101 of the reported bill would amend section 501 (a)
(1) of the Federal Food, Drug, and Cosmetic Act to deem a drug
to be adulterated if the methods, facilities, or controls used in its
manufacture, processing, packaging, or holding fail to conform to,
or are not operated or administered in conformity with, good manu-
facturing practices as determined in accordance with regulations
to be issued by the Secretary of Health, Education, and Welfare
which are designed to assure that the drug is safe and has the iden-
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990 LEGAL COMPILATION—PESTICIDES
tity and strength and meets the quality and purity characteristics
which it purports or is represented to possess. The phrase "oper-
ated or administered in conformity with current good manufactur-
ing practice" encompasses key technical and professional personnel
responsible for the safety of the drug, and its identity, strength,
quality, and purity characteristics.
The promulgation of these regulations would be subject to oppor-
tunity for hearing and judicial review. Thus, legal action could be
brought against firms failing to abide by these standards and
against the products they ship. r 01
LP- ^J
NEW DRUG CLEARANCE PROCEDURE
Section 104 makes a number of important changes in the new
drug procedures.
Section 104 (a) eliminates the provisions of existing law under
which a new-drug application becomes effective automatically at
the expiration of 60 or 180 days if the Department does not take
positive action to prevent this. Under the bill, a new-drug applica-
tion is not effective unless it has affirmative approval both for safe-
ty and effectiveness.
In section 104 (b) the committee revised the time schedule for
action on new-drug applications. The Secretary has 180 days, after
filing of a new drug application, to approve it or give the appli-
cant notice of an opportunity for hearing. The applicant has 30
days after notice to accept the opportunity for hearing-, the hearing
must start within 90 days unless a different date is agreed upon,
and it must proceed on an expedited basis. The Secretary has 90
days, after completion of the hearing, to issue his order.
Section 104 (c) provides that any order refusing, revoking, or
suspending approval of a new-drug application shall be withdrawn
by the Secretary when he finds that the facts so require.
Section 104 (d) changes the judicial review over the denial or
withdrawal of approval of a new drug from the district courts to
the U.S. courts of appeals. This is a review, on the record, of admin-
istrative action, which more appropriately belongs in the courts of
[p. 10]
appeals. And this procedure is the same as the judicial review
under other sections of the Federal Food, Drug, and Cosmetic Act.
Pending appeals taken prior to enactment of the bill would not be
affected.
Section 104 (e) contains conforming amendments in sections 301
and 503 (b) of the Federal Food, Drug, and Cosmetic Act to reflect
the fact that affirmative approval, rather than automatic effective
dates, has been required for new drugs.
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STATUTES AND LEGISLATIVE HISTORY 991
Section 104 (f) amends sections 409 (c) and 706 (d) of the
Federal Food, Drug, and Cosmetic Act, by making the anticancer
clause of the Food Additives Amendment of 1958 and the Color
Additive Amendment of 1960 inapplicable to chemicals, such as
veterinary drugs, when used in feed for food-producing animals
if the Secretary finds (1) that under the conditions of use and
feeding specified in the proposed labeling and reasonably certain
to be followed in practice, such additive will not adversely affect
the animals for which such feed is intended, and (2) that no resi-
due of the additive will be found (by methods of examination
prescribed or approved by the Secretary by regulations) in any
edible portion of the animal after slaughter or in any food, such
as milk or eggs, yielded by or derived from the living animal.
[p. HI
New Drug Clearance Procedure
Sec. 104 (a) Section 505(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 335(a)) is amended to read as follows:
"No person shall introduce or deliver for introduction into
interstate commerce any new drug, unless an approval of an appli-
cation filed pursuant to subsection (b) is effective with respect to
such drug."
(b) Section 505 (c) of such Act (21 U.C. 355 (c)) is amended
to read as follows.•
[p. 59]
"(c) Within one hundred and eighty days after the filing of an
application under this subsection, or such additional period as may
be agreed upon by the Secretary and the applicant, the Secretary
shall either—
"(1) approve the application if he then finds that none of
the grounds for denying approval specified in subsection (d)
applies, or
"(2) give the applicant notice of an opportunity for a hear-
ing before the Secretary under subsection (d) on the question
whether such application is approvable. If the applicant elects
to accept the opportunity for hearing by written request with-
in thirty days after such notice, such hearing shall commence
not more than ninety days after the expiration of such thirty
days unless the Secretary and the applicant otherwise agree.
Any such hearing shall thereafter be conducted on an expe-
dited basis and the Secretary's order thereon shall be issued
loithin ninety days after such hearing is completed."
(c) Section 505 (f) of such Act (21 U.S.C. 355 (f)) is amended
to read as follows:
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992 LEGAL COMPILATION—PESTICIDES
"(f) Whenever the Secretary finds that the facts so require, he
shall revoke any previous order under subsection (d) or (e) refus-
ing, withdrawing, or suspending approval of an application and
shall approve such application or reinstate such approval, as may
be appropriate."
(d) (1) The first four sentences of section 505 (h) of such Act
(21 U.S.C. 355 (h)) are amended to read as follows:
"(h) An appeal may be taken by the applicant from an order of
the Secretary refusing or withdrawing approval of an application
under this section. Such appeal shall be taken by filing in the United
States court of appeals for the circuit wherein such applicant
resides or has his principal place of business, or in the United
States Court of Appeals for the District of Columbia Circuit, with-
in sixty days after the entry of such order, a written petition pray-
ing that the order of the Secretary be set aside. A copy of such
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 certify and file in the court the
record upon which the order complained of was entered, as pro-
vided in section 2112 of title 28, United States Code. Upon the fil-
ing of such petition such court shall have exclusive jurisdiction to
affirm or set aside such order, except that until the filing of the
record the Secretary may modify or set aside his order."
(2) The ninth sentence of such section 505 (h) is amended to
read as follows: "The judgment of the court affirming or setting
aside 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 section 1254 of title 28 of the United
States Code."
(3) The amendments made by this subsection shall not apply to
any appeal taken prior to the date of enactment of this Act.
(e) (1) Section 801 (1) of such Act (21 U.S.C. 331 (I)) is amended
by (1) inserting "approval of" before "an application", and (2)
striking out "effective" and inserting in lieu thereof "in effect".
(2) Clause (C) of section 503 (b) (1) of such Act (21 U.S.C. 353
(b) (1) ) is amended by striking out "effective" and inserting in lieu
thereof "approved".
(f) (1) Clause (A) of paragraph (3) of section 409 (c) of such Act
(21 U.S.C. 348 (c) ) is amended by inserting before the semicolon at
the end thereof the following: ", except that this proviso shall not
apply with respect to the use of a substance as an ingredient of
feed for animals which are raised for food production, if the Sec-
retary finds (i) that, under the conditions of use and feeding
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STATUTES AND LEGISLATIVE HISTORY 993
specified in proposed labeling and reasonably certain to be fol-
lowed in practice, suck additive will not adversely affect the ani-
mals for which such feed is intended and (ii) that no residue of
the additive will be found by methods of examination prescribed
or approved by the Secretary by regulations, which regulations
shall not be subject to subsections (f) and (g) in any edible por-
tion of such animals after slaughter or in any food yielded by or
derived from the living animal" r „_,
LP- 60J
*******
(2) Subparagraph (B) of paragraph (5) of section 706
(b) of such Act (21 U.S.C. 376 (b)) is amended by inserting before
the period at the end of the subparagraph a colon and the following
proviso: "Provided, That clause (i) of this subparagraph (B) shall
not apply ivith respect to the use of a color additive as an ingredient
of feed for animals which are raised for food production, if the
Secretary finds that, under the conditions of use and feeding speci-
fied in proposed labeling and reasonably certain to be followed in
practice, such additive will not adversely affect the animals for
which such feed is intended, and that no residue of the additive will
be found (by 'methods of examination prescribed or approved by
the Secretary by regulations, which regulations shall not be subject
to subsection (d) ) in any edible portion of such animals after
slaughter or in any food yielded by or derived from the living
animal". [p
1.1 la (3) COMMITTEE OF CONFERENCE
H.R. REP. No. 2526, 87th Cong., 2d Sess. (1962)
DRUG AMENDMENTS OF 1962
OCTOBER 3,1962.—Ordered to be printed
Mr. ROBERTS of Alabama, from the committee of conference,
submitted the following
CONFERENCE REPORT
[To accompany S. 1552]
The committee of conference on the disagreeing votes of the two
Houses on the amendments of the House to the bill (S. 1552) to
amend and supplement the laws with respect to the manufacture
and distribution of 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 Senate recede from its disagreement to the amendment
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994 LEGAL COMPILATION—PESTICIDES
of the House 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 House amend-
ment insert the following:
That this Act, divided into titles and sections according to the fol-
lowing table of contents, may be cited as the "Drug Amendments
of 1962."
*******
[p.l]
New Drug Clearance Procedure
Sec. 104. (a) Section 505(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(a)), is amended to read as follows:
"(a) No person shall introduce or deliver for introduction into
interstate commerce any new drug, unless an approval of an appli-
cation filed pursuant to subsection (b) is effective with respect to
such drug."
(b) Section 505(c) of such Act (21 U.S.C. 355(c)) is amended to
read as follows:
"(c) Within one hundred and eighty days after the filing of an
application under this subsection, or such additional period as may
be agreed upon by the Secretary and the applicant, the Secretary
shall either— r _,
[p. 5]
"(1) approve the application if he then finds that none of
the grounds for denying approval specified in subsection (d)
applies, or
" (2) give the applicant notice of an opportunity for a hear-
ing before the Secretary under subsection (d) on the question
whether such application is approvable. If the applicant elects
to accept the opportunity for hearing by written request with-
in thirty days after such notice, such hearing shall commence
not more than ninety days after the expiration of such thirty
days unless the Secretary and the applicant otherwise agree.
Any such hearing shall thereafter be conducted on an expe-
dited basis and the Secretary's order thereon shall be issued
within ninety days after the date fixed by the Secretary for
filing final briefs."
(c) Section 505(f) of such Act (21 U.S.C. 355(f)) is amended to
read as follows:
"(f) Whenever the Secretary finds that the facts so require, he
shall revoke any previous order under subsection (d) or (e) refus-
ing, withdrawing, or suspending approval of an application and
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STATUTES AND LEGISLATIVE HISTORY 995
shall approve such application or reinstate such approval, as may
be appropriate."
(d)(l) The first four sentences of section 505(h) of such Act
(21 U.S.C. 355(h)) are amended to read as follows: "An appeal
may be taken by the applicant from an order of the Secretary refus-
ing or withdrawing approval of an application under this section.
Such appeal shall be taken by filing in the United States court of ap-
peals for the circuit wherein such applicant resides or has his prin-
cipal place of business, or in the United States Court of Appeals for
the District of Columbia Circuit, within sixty days after the entry of
such order, a written petition praying that the order of the Secre-
tary be set aside. A copy of such petition shall be forthioith trans-
mitted by the clerk of the court to the Secretary, or any officer
designated by him for that purpose, and thereupon the Secretary
shall certify and file in the court the record upon which the order
complained of was entered, as provided in section 2112 of title 28,
United States Code. Upon the filing of such petition such court
shall have exclusive jurisdiction to affirm or set aside such order,
except that until the filing of the record the Secretary may modify
or set aside his order."
(2) The ninth sentence of such section 505(h) is amended to read
as follotvs: "The judgment of the court affirming or setting aside
any such order of the Secretary shall be final, subject to review by
the Supreme Court of the United States upon certiorari or certifi-
cation as provided in section 1254 of title 28 of the United States
Code."
(3) The amendments made by this subsection shall not apply to
any appeal taken prior to the date of enactment of this Act.
(e) (1) Section 301(1) of such Act (21 U.S.C. 331(1)) is amended
by (1) inserting "approval of" before "an application", and (2)
striking out "effective" and inserting in lieu thereof "in effect".
(2) Clause (C) of section 503(b)(l) of such Act (21 U.S.C.
353(b) (1)) is amended by striking out "effective" and inserting in
lieu thereof "approved".
(f)(l) Clause (A) of paragraph (3) of section 409 (c) of such Act
(21 U.S.C. 348 (c)) is amended by inserting before the semicolon
at the end thereof the following: ", except that this proviso shall
not apply with respect to the use of a substance as an ingredient
of feed for animals which are raised for food production, if the Sec-
retary finds (i) that, under the conditions of use and feeding speci-
fied in proposed labeling and reasonably certain to be followed in
practice, such additive will not adversely affect the animals for
[p. 6]
-------
996 LEGAL COMPILATION—PESTICIDES
which such feed is intended, and (ii) that no residue of the additive
will be found (by methods of examination prescribed or approved
by the Secretary by regulations, which regulations shall not be
subject to subsections (f) and (g) in any edible portion of such
animal after slaughter or in any food yielded by or derived from
the living animal".
(2) Subparagraph (B) of paragraph (5) of section 706(b) of
such Act (21 U.S.C. 376(b)) is amended by inserting before the
period at the end of the subparagraph a colon and the following
proviso: "Provided, That clause (i) of this subparagraph (B) shall
not apply with respect to the use of a color additive as an ingredi-
ent of feed for animals which are raised for food production, if the
Secretary finds that, under the conditions of use and feeding speci-
fied in proposed labeling and reasonably certain to be followed in
practice, such additive will not adversely affect the animals for
which such feed is intended, and that no residue of the additive
will be found (by methods of examination prescribed or appraised
by the Secretary by regulations, which regulations shall not be
subject to subsection (d)) in any edible portion of such animals
after slaughter or in any food yielded by or derived from the living
animal". r „-.
ANIMAL FEED
The House amendment contained a provision amending the anti-
cancer clause of the food additives amendment and the color addi-
tive amendment of the Federal Food, Drug-, and Cosmetic Act by
[p. 20]
making this clause inapplicable to chemicals such as veterinary
drugs when used in feed for food-producing animals if the Secre-
tary finds (1) that under the conditions of use and feeding speci-
fied in the proposed labeling and reasonably certain to be followed
in practice, such additive will not adversely affect the animals for
which such feed is intended, and (2) that no residue of the addi-
tive will be found (by methods of examination prescribed or
approved by the Secretary by regulations) in any edible portion
of the animal after slaughter or in any food such as milk or eggs
yielded by or derived from the living animal.
The Senate bill did not contain this provision.
The conference substitute adopts the House provision in this
respect.
[p. 21]
-------
STATUTES AND LEGISLATIVE HISTORY
997
l.lla (4) CONGRESSIONAL RECORD, VOL. 108 (1962)
l.lla (4) (a) Aug. 23: Amended and passed Senate, p. 17422
[No Relevant Discussion on Pertinent Section]
l.lla (4) (b) Sept. 27: Discharged, amended and passed House, pp.
21052,21083, 21097
Mr. HARRIS. of overwhelming proof of danger to
the consumer from eating meat from
such animals, the farm people believe
they should have the right to use this
additive in feeding livestock.
But, Mr. Chairman, there is no jus-
tification—economic or otherwise—for
permitting the use of cancer-inducing
coloring matter in this feed. The ani-
mals, I believe, cannot distinguish col-
ors. But the farm hands apparently
can. So the dangerous additive, which
must not be fed to the cattle for at least
several days before slaughter, to make
sure there is no residue in the meat, is
identified with coloring matter to dif-
ferentiate one kind of feed from an-
other.
ANIMAL FEED
The committee amended the anti-
cancer clause of the food additives
amendment and the color additive
amendment of the Federal Food, Drug,
and Cosmetic Act by making this clause
inapplicable to chemicals such as vet-
terinary drugs when used in feed for
food-producing animals if the Secre-
tary finds first, that under the condi-
tions of use and feeding specified in the
proposed labeling and reasonably cer-
tain to be followed in practice, such
additive will not adversely affect the
animals for which such feed is intend-
ed; and second, that no residue of the
additive will be found—by methods of
examination prescribed or approved by
the Secretary by regulations—in any
edible portion of the animal after
slaughter or in any food such as milk
or eggs yielded by or derived from the
living animal.
[p.21052]
Mrs. SULLIVAN. Mr. Chairman, I
offer an amendment.
The Clerk read as follows:
Amendment offered by Mrs. SULLIVAN: On
page 46, line 4, strike out lines 4 through 19.
Mrs. SULLIVAN. Mr. Chairman,
my previous amendment was directed
at a proposal to allow more feed manu-
facturers to use a cancer-inducing sub-
stance in feed for meat animals. There
is some economic justification for using
stilbestrol in fattening cattle, if it can
be proved completely safe—as it has
not been so far. But farmers can fatten
their livestock to market weight much
faster and on less feed by using these
additives, and therefore, in the absence
Now just look what we are getting
into here. The feed manufacturers say
they have to use colors, which are now
prohibited for this use because they
can cause cancer. Are we allowing this
very potent and very dangerous can-
cer-inducing substance, stilbestrol, to
be handled by farmhands who are un-
able to read directions on the label or
package, and must have special colors
used to guide them—colors which are
cancer inducing?
Before the color additives act was
passed in 1960, I obtained and put in
the CONGRESSIONAL RECORD evidence
from National Institutes of Health
scientists, cancer experts, that there
is no such thing as a harmless amount
of a cancer-inducing substance as far
as humans are concerned.
In this bill—in the section to which I
previously offered an amendment—we
would let more feed manufacturers use
a cancer-inducing substance in animal
feed for economic reasons. Now, in this
-------
998
LEGAL COMPILATION—PESTICIDES
section, we would be saying: put a little
more cancer in, for color, to help the
farmhand know which sack to use in
the final days before slaughter. Are we
to believe our farmers are too dumb to
handle this material otherwise?
If the man can't read or understand
directions, how do we dare trust him
with these potent, dangerous, sub-
stances, to use the right proportion or
amount?
There is no justification for permit-
ting cancer-inducing coloring matter
in anything going into our food supply.
The Delaney clause prohibits it. Let us
uphold that principle. This provision of
the bill must come out.
Mr. ROBERTS of Alabama. Mr.
Chairman, I rise in opposition to the
amendment.
Mr. Chairman, the same arguments
that apply with reference to the gentle-
woman's other amendment apply to
this amendment. The only reason, I
suppose, for offering this amendment is
that veterinary drugs have been clas-
sified both as food additives and as
color additives. I repeat that there was
no proof before the subcommittee that
the use of stilbestrol as presently used
under the direction of the Food and
Drug Administration has been shown
to induce cancer in animals. No resi-
due has been found, no harm to the
animal.
The same proposition was before the
House a few minutes ago on a similar
amendment, and with the additional
power of withdrawal contained in the
omnibus bill those people who might
have some suspicion of this stilbestrol
are in a better position than they ever
have been before. The Food and Drug
Administration testified in favor of
this amendment. It has been asked for
by Secretary Ribicoff when he was
head of the Department of Health,
Education, and Welfare, also Secre-
tary Flemming. It has been approved
by studies made by the American Medi-
cal Association and by the National
Institutes of Health. I would respec-
tively ask that the House vote "no" on
this amendment.
The CHAIRMAN. The question is on
the amendment offered by the gentle-
woman from Missouri [Mrs. SULLI-
VAN].
The amendment was rejected.
[p.21083]
SEC. 104 "(f)(l) Clause (A) of paragraph
(3) of section 409(c) of such Act (21 U.S.C.
348 (c)) is amended by inserting before the semi-
colon at the end thereof the Mowing: ', ex-
cept that this proviso shall not apply with re-
spect to the use of a substance as an ingre-
dient of feed for animals which are raised for
food production, if the Secretary finds (i) that,
under the conditions of use and feeding speci-
fied in proposed labeling and reasonably cer-
tain to be followed in practice, such additive
will not adversely affect the animals for which
such feed is intended, and (ii) that no residue
of the additive will be found (by methods of
examination prescribed or approved by the
Secretary by regulations, which regulations
shall not be subject to subsections (f) and (g))
in any edible portion of such animal after
slaughter or in any food yielded by or derived
from the living animal'.
"(2) Subparagraph (B) of paragraph (5) of
section 706(b) of such Act (21 U.S.C. 376(b))
is amended by inserting before the period at the
end of the subparagraph a colon and the follow-
ing proviso: 'Provided. That clause (i) of this
subparagraph (B) shall not apply with respect
to the use of a color additive as an ingredient
of feed for animals which are raised for food
production, if the Secretary finds that, under
the conditions of use and feeding specified in
proposed labeling and reasonably certain to be
followed in practice, such additive will not ad-
versely affect the animals for which such feed
is intended, and that no residue of the additive
will be found (by methods of examination pre-
scribed or approved by the Secretary by regu-
lations, which regulations shall not be subject
to subsection (d) ) in any edible portion of such
animals after slaughter or in any food yielded
by or derived from the living animal*.
[p.21097]
l.lla (4) (c) Oct. 3: Senate concurred in conference report, pp.
22039, 22053
Mr. KEFAUVER. The conferees also accepted a House
provision which would correct a need-
-------
STATUTES AND LEGISLATIVE HISTORY
999
less and unintentional inequity in the
application of the food additive anti-
cancer proviso to additives for animal
feed, while preserving in its full vigor
the consumer protection now afforded
by that provision.
The provision stipulates that the an-
ticancer proviso of existing law shall
not apply with respect to the use of a
substance—for example, a veterinary
drug—as an ingredient of feed for ani-
mals which are raised for food produc-
tion, if the Secretary finds, first, that,
under the conditions of use and feeding
specified in proposed labeling and rea-
sonably certain to be followed in prac-
tice, such additive will not adversely
affect the animals for which such feed
is intended; and, second, that no resi-
due of the additive will be found in any
edible portion of such animals after
slaughter or in any food product of the
living animal—such as milk or eggs.
Another amendment would similarly
amend the basic act—which is the cor-
responding anticancer clause contained
in the color additive amendment of
1960 to the basic act.
It should be emphasized that where
a new drug is involved in these fields
and subsequent information and new
evidence raise a question as to its safe-
ty, it can be withdrawn under the new
withdrawal and suspension powers
provided for in section 102 of the bill.
[p.22039]
Mr. HUMPHREY.
VETERINARY DRUG PROVISION
I am particularly gratified to note
that the conferees have accepted the
House amendment clarifying the anti-
cancer clause of the food additives
amendment and the color additive
amendment of the Federal Food, Drug,
and Cosmetic Act, by making this
clause inapplicable to chemicals such
as veterinary drugs when used in feed
for food-producing animals, if—I em-
phasize—if, the Secretary finds:
First. That under the conditions of
use and feeding specified in the pro-
posed labeling and reasonably certain
to be followed in practice, such additive
will not adversely affect the animals
for which such feed is intended, and
Second. That no residue of the addi-
tive will be found—by methods of ex-
amination prescribed or approved by
the Secretary by regulations—in any
edible portion of the animal after
slaughter or in any food, such as milk
or eggs, yielded by or derived from the
living animal.
This corrects a needless and uninten-
tional inequity in the application of the
food additive anticancer proviso to ad-
ditives for animal feed, while preserv-
ing in its full vigor the consumer pro-
tection now afforded by that provision.
I reiterate—consumer protection is
assured. [p. 22053]
l.lla (4) (d) Oct. 4: House concurs in conference report, p. 22321
[Conference Report excerpt]
ANIMAL FEED
The House amendment contained a provision
amending the anticancer clause of the food
additives amendment and the color additive
amendment of the Federal Food, Drug, and
Cosmetic Act by making this clause inapplicable
to chemicals such as veterinary drugs when used
in feed for food-producing animals iŁ the Sec-
retary finds (1) that under the conditions of
use and feeding specified in the proposed label-
ing and reasonably certain to be followed in
practice, such additive will not adversely affect
the animals for which such feed is intended,
and (2) that no residue of the additive will be
found (by methods of examination prescribed
or approved by the Secretary by regulations)
in any edible portion of the animal aftei slaugh-
ter or in any food such as milk or egps yielded
by or derived from the living animal.
The Senate bill did not contain this provision.
The conference substitute adopts the House
provision in this respect.
[p. 22321]
-------
1000 LEGAL COMPILATION—PESTICIDES
l.llb NATIONAL ADVISORY COUNCIL AMENDMENTS
October 30, 1970, P.L. 91-515, Title VI, §601 (d) (2), 84 Stat. 1311
TITLE VI—MISCELLANEOUS
NATIONAL ADVISORY COUNCIL
SEC. 601.
*******
[p.1310]
(d) (1) Subsection (g) of section 408 of the Food, Drug, and
Cosmetic Act is amended by striking out "as compensation for
their services a reasonable per diem, for time actually spent in the
work of the committee, and shall in addition be reimbursed for
their necessary traveling and subsistence expenses while so serving
away from their places of residence," after "shall receive" and
by inserting in lieu thereof "compensation and travel expenses in
accordance with subsection (b) (5) (D) of section 706."
(2) Subparagraph (D) of paragraph (5) of subsection (b) of
section 706 of such Act is amended by striking out the third sen-
tence thereof and by inserting in lieu thereof the following new
sentence: "Members of any advisory committee established under
this Act, while attending conferences or meetings of their commit-
tees or otherwise serving at the request of the Secretary, shall be
entitled to receive compensation at rates to be fixed by the Secre-
tary but at rates not exceeding the daily equivalent of the rate
specified at the time of such service for grade GS-18 of the Gen-
eral Schedule, including travel time; and while away from their
homes or regular places of business they may be allowed travel
expenses, including per diem in lieu of subsistence, as authorized
by section 5703 (b) of title 5 of the United
[p.1311]
-------
STATUTES AND LEGISLATIVE HISTORY 1001
l.llb (1) HOUSE COMMITTEE ON INTERSTATE AND FOR-
EIGN COMMERCE
H.B. REP. No. 91-1297, 91st Cong., 2d Sess. (1970)
HEART DISEASE, CANCER, STROKE, AND KIDNEY
DISEASE AMENDMENTS OF 1970
JULY 13, 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
REPORT
[To accompany H.R. 17570]
The Committee on Interstate and Foreign Commerce, to whom
was referred the bill (H.R. 17570) to amend title IX of the Public
Health Service Act so as to extend and improve the existing pro-
gram relating to education, research, training, and demonstra-
tions in the fields of heart disease, cancer, stroke, and other major
diseases and conditions, and for other purposes, having considered
the same, report favorably thereon with amendments and recom-
mend that the bill as amended do pass.
The amendments are as follows:
[p-1]
PRINCIPAL PURPOSE OP THE BILL
The bill as reported by the committee would extend for 3 years
the existing program known as regional medical programs, under
which grants are made for local based programs designed to
improve the diagnosis, care, and treatment of heart disease, can-
cer, and stroke. The legislation would also expand the coverage of
the program to cover kidney disease, and would make a number
of relatively minor modifications in the program which experience
has shown to be desirable.
[p. 3]
**#*###
[P-4]
[No Relevant Discussion on Pertinent Section]
-------
1002 LEGAL COMPILATION—PESTICIDES
l.llb (2) SENATE COMMITTEE ON LABOR AND PUBLIC
WELFARE
S. REP. No. 91-1090, 91st Cong., 2d Sess. (1970)
THE HEALTH SERVICES IMPROVEMENT ACT OF 1970
AUGUST 11,1970.—Ordered to be printed
Mr. YARBOROUGH, from the Committee on Labor and Public
Welfare, submitted the following
REPORT
[To accompany S. 3355]
The Committee on Labor and Public Welfare, to which was
referred the bills (S. 3355 and related bills) to amend titles III
and IX of the Public Health Service Act so as to revise, extend,
and improve the programs of research, investigation, education,
training and demonstrations authorized thereunder, and for other
purposes having considered the same, reports favorably thereon
with amendments and recommends that the bill as amended do
pass.
SUMMARY
S. 3355 would extend for five years (fiscal year 1971 through
fiscal year 1975) certain of the authorities under titles III and IX
of the Public Health Service Act.
The bill would:
1. extend and improve the Regional Medical Programs authority
(Title IX).
2. extend and improve the Comprehensive Health Planning and
Services authority (section 314 of title III).
3. extend and improve the authority for the National Center
for Health Services Research and Development (section 304 of
title III).
4. improve the authority for the National Center for Health
Statistics (section 305 of title III).
5. permit for the joint administration of projects involving more
than one of the above mentioned authorities with the exception of
section 305 (section 310a of title III).
6. require that the Secretary of HEW submit an annual report
concerning the effectiveness of these programs (section 310b of
title III).
7. create a National Council on Health Policy in the Executive
-------
STATUTES AND LEGISLATIVE HISTORY 1003
Office of the President to conduct studies, research, and investi-
gations to set goals for a national health policy for the United
States.
8. enable the Secretary of HEW to authorize carriers partici-
pating in Federal health benefit programs for Federal employees
to issue contracts for prepaid group practice health services to
any person, whether or not such persons are Federal employees.
[p. 2]
l.llb (3) COMMITTEE OF CONFERENCE
H.R. REP. No. 91-1590, 91st Cong., 2d Sess. (1970)
REGIONAL MEDICAL PROGRAMS AND COMPREHENSIVE
HEALTH PLANNING AND SERVICES ACT OF 1970
OCTOBER 8,1970.—Ordered to be printed
Mr. STAGGERS, from the committee of conference,
submitted the following
CONFERENCE REPORT
[To accompany H.R. 17570]
The committee of conference on the disagreeing votes of the two
Houses on the amendments of the Senate to the bill (H.R. 17570)
to amend title IX of the Public Health Service Act so as to extend
and improve the existing program relating to education, research,
training, and demonstrations in the fields of heart disease, cancer,
stroke, and other related diseases, 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.n
*******
TITLE VI—MISCELLANEOUS
NATIONAL ADVISORY COUNCIL
SEC. 601. (a)(l) Sections 217(b), 432(a), 443(b), and 703(c) of
the Public Health Service Act are amended by inserting "or com-
mittees" after "councils" wherever it appears therein.
(2) Sections 431, 432(b), 433, 443, and 452 of such Act are
-------
1004 LEGAL COMPILATION—PESTICIDES
amended by inserting "or committee" after "council" wherever
it appears therein.
(3) Subsections (b) and (c) of section 222 of such Act are
amended by inserting "council or" before "committee" wherever
it appears therein.
(4) Such section is further amended by inserting in the heading
thereof "COUNCILS OR" before "COMMITTEES".
(b)(l) Subsection (c) of section 208 of the Public Health Service
Act is amended to read:
"(c) Members of the National Advisory Health Council and
members of other national advisory or review councils or commit-
tees established under this Act, including members of the Techni-
cal Electronic Product Radiation Safety Standards Committee
and the Board of Regents of the National Library of Medicine,
but excluding ex officio members, while attending conferences or
meetings of their respective councils or committees or while other-
wise serving at the request of the Secretary, shall be entitled to
[p. 14]
receive compensation at rates to be fixed by the Secretary, but
at rates not exceeding the daily equivalent of the rate specified
at the time of such service for grade GS-18 of the General Sched-
ule, including travel time; and ivhile away from their homes or
regular places of business they may be allowed travel expenses,
including per diem in lieu of subsistence, as authorized by section
5703(b) of title 5 of the United States Code for persons in the Gov-
ernment service employed intermittently."
(2) The second sentence of subsection (d) of section 306, the sec-
ond sentence of subsection (d) of section 307, the first sentence
of paragraph (2) of subsection (f) cf section 358, subsection (d) of
section (373), subsection (e) of section 641, subsection (d) of sec-
tion 373, subsection (e) of section 641, subsection (d) of section
703, subsection (d) of section 725, subsection (d) of section 774,
subsection (c) of section 841, and subsection (c) of section 905 of
such Act are deleted.
(3) Paragraph (2) of subsection (f) of section 358 is further
amended by striking out "under this subsection" in the second
sentence thereof and by inserting in lieu thereof "to members of
the Committee who are not officers or employees of the United
States pursuant to subsection (c) of section 208 of this Act".
(4) Subsection (d) of section 905 of such Act is redesigned as
subsection (c).
(c)(l) Subsection (a) of section 222 of such Act is amended
to read:
-------
STATUTES AND LEGISLATIVE HISTORY 1005
"(a) The Secretary may, without regard to the provisions of
title 5, United States Code, governing appointments in the com-
petitive service, and without regard to the provisions of chapter
51 and sub chapter III of chapter 53 of such title relating to classi-
fication and General Schedule pay rates, from time to time, appoint
such advisory councils or committees (in addition to those author-
ized to be established under other provisions of law), for such
periods of time, as he deems desirable with such period commenc-
ing on a date specified by the Secretary for the purpose of advising
him in connection with any of his functions."
(2) Subsection (c) of such section is amended by inserting "or
programs" after "projects".
(d)(l) Subsection (g) of section 408 of the Food, Drug, and Cos-
metic Act is amended by striking out "as compensation for their
services a reasonable per diem, for time actually spent in the work
of the committee, and shall in addition be reimbursed for their
necessary traveling and subsistence expenses while so serving
away from their places of residence." after "shall receive" and by
inserting in lieu thereof "compensation and travel expenses in
accordance with subsection (b) (5) (D) of section 706."
(2) Subparagraph (D) of paragraph (5) of subsection (b) of
section 706 of such Act is amended by striking out the third sen-
tence thereof and by inserting in lieu thereof the following new
sentence: "Members of any advisory committee established under
this Act, while attending conferences or meetings of their commit-
tees or otherwise serving at the request of the Secretary, shall be
entitled to receive compensation at rates to be fixed by the Secre-
tary but at rates not exceeding the daily equivalent of the rate
specified at the time of such service for grade GS-18 of the General
Schedule, including traveling time; and while away from their
homes or regular places of business they may be allowed travel
expenses, including per diem in lieu of subsistence, as authorized
by section 5703 (b) of title (5) of the United States Code for
persons in the Government service employed intermittently."
[p.15]
COMPENSATION OF ADVISORY COUNCIL MEMBERS, ETC.
The Senate amendment contained a provision not in the House
bill which would amend the Public Health Service Act and the
Federal Food, Drug, and Cosmetic Act to provide uniform rules
on compensation of advisory council members and to authorize
committees to be established where there is authority to establish
advisory councils. The conference substitute contains the provision
of the Senate amendment. [p. 22]
-------
1006
LEGAL COMPILATION—PESTICIDES
l.llb (4) CONGRESSIONAL RECORD, VOL. 116 (1970)
l.llb (4) (a) Aug. 12: Considered and passed House, p. 28532
[No Relevant Discussion on Pertinent Section]
l.llb (4) (b) Sept. 9: Considered and passed Senate, p. 31019
Mr. JAVITS.
* * * * *
[Sec. 104 (f)]
"(2) Subparagraph (D) of paragraph (5)
of subsection (b) of section 706 of such Act is
amended by striking out the third sentence
thereof and by inserting in lieu thereof the fol-
lowing new sentence:
" 'Members of any advisory committee es-
tablished under this Act while attending con-
ferences or meetings of their committees or
otherwise serving at the request of the Secre-
tary, shall be entitled to receive compensation
at rates to be fixed by the Secretary but not
exceeding the maximum rate specified at the
time of such service for grade GS-18 in section
5332 of title 5, United States Code, including
travel time; and while away from their homes
or regular places of business they may be al-
lov/ed travel expenses, including per diem in
lieu of subsistence, as authorized by section B
of the Administrative Expenses Act of 1946
(6 U.S.C. 73b-2) for persons in the Govern-
ment service employed intermittently.' "
Mr. JAVITS. Mr. President, this is
exactly the amendment offered by the
Senator from Texas (Mr. YARBOROUGH ).
It relates to compensation of members
of the Public Health Service Advisory
Council and committees which are es-
tablished under this bill.
Current provisions of the PHS Act
relating to compensation of members
of the Public Health Service advisory
councils and committees establish vary-
ing and widely disparate rates of re-
muneration for the members of these
various groups. At present, and for no
discernible reason, some groups are en-
titled to less than half of the compen-
sation available to the membership of
others. These proposed amendments
will permit the establishment of uni-
form rates of compensation for all
members of these councils and commit-
tees and will thus insure consistent
and equitable treatment. They author-
ize compensation at rates to be fixed
by the Secretary, not to exceed the
maximum rate specified at the time of
service for grade GS-18. They provide
for a uniform method of payment for
expenses including per diem in lieu of
subsistence as authorized for persons
in the Government service employed
intermittently. The advisory councils
and committees play a major role in
the NIH programs and those of other
Public Health Service agencies. Equi-
table treatment of their membership
in the manner of compensation is in
keeping with the importance of their
responsibilities.
Also, the Amendment being submit-
ted is similar to part C of the General
Education Provisions Act and repre-
sents the administration's effort—
which acts here through me, as I am
the ranking minority member of the
committee—to bring about this degree
of uniformity.
Again I express my gratitude to the
Senator from Texas (Mr. YARBOROUGH) .
I hope the Senate will take favorable
action on this amendment.
Mr. YARBOROUGH. Mr. President,
I congratulate the distinguished Sen-
ator from New York. As the ranking
minority member of the committee he
has had a hand in every health bill
that has been passed. He is a leader
in this field and his services are in-
valuable.
We have had a great body of health
legislation due to the cooperation of
the Senator from New York, as the
ranking minority member of the com-
mittee, and our side. We would not
have had this body of health legisla-
tion without the active cooperation of
the distinguished Senator, and I thank
him for it.
The PRESIDING OFFICER. The
question is on agreeing to the amend-
ment of the Senator from New York.
The amendment was agreed to.
[p.31019]
-------
STATUTES AND LEGISLATIVE HISTORY 1007
l.llb (4) (c) Oct. 13: House agrees to conference report, pp.
36589-36591
[No Relevant Discussion on Pertinent Section]
l.lld (4) (d) Oct. 14: Senate agrees to conference report, pp.
36888-36892
[No Relevant Discussion on Pertinent Section]
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)]
REGULATIONS AND HEARINGS—AUTHORITY TO
PROMULGATE REGULATIONS
§371.
(a) The authority to promulgate regulations for the efficient
enforcement of this chapter, except as otherwise provided in this
section, is vested in the Secretary.
Regulations for imports and exports
(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 381 of this title,
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.
Conduct of hearings
(c) Hearings authorized or required by this chapter shall be
conducted by the Secretary of Health, Education, and Welfare or
such officer or employee as he may designate for the purpose.
Effectiveness of definitions and standards of identity
(d) The definitions and standards of identity promulgated in
accordance with the provisions of this chapter shall be effective
for the purposes of the enforcement of this chapter, notwithstand-
ing such definitions and standards as may be contained in other
laws of the United States and regulations promulgated thereunder.
Procedure for establishment
(e) (1) Any action for the issuance, amendment, or repeal of
any regulation under section 341, 343(j), 344(a), 346, 351 (b), or
352 (d) or (h), of this title 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
-------
1008 LEGAL COMPILATION—PESTICIDES
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) of
this subsection, 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) of this subsection 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 pub-
lic hearing- upon such objections. Until final action upon such ob-
jections is taken by the Secretary under paragraph (3) of this
subsection, the filing of such objections shall operate to stay the
effectiveness of those provisions of the order to which the objec-
tions 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 pub-
lication unless the Secretary finds that emergency conditions
exist necessitating an earlier effective date, in which event the Sec-
retary shall specify in the order his findings as to such conditions.
Review of order
(f) (1) In a case of actual controversy as to the validity of
any order under subsection (e) of this section, 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 United States court of appeal for the circuit
-------
STATUTES AND LEGISLATIVE HISTORY 1009
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.
(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 reason-
able grounds for the failure to adduce such evidence in the pro-
ceeding 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 recommen-
dation, if any, 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 per-
manently. 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.
(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 346 and 347 of
Title 28.
(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 pro-
vided by law.
Copies of records of hearings
(g) A certified copy of the transcript of the record and pro-
ceedings under subsection (e) of this section shall be furnished
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1010 LEGAL COMPILATION—PESTICIDES
by the Secretary to any interested party at his request, and pay-
ment of the costs thereof, and shall be admissible in any criminal,
libel for condemnation, exclusion of imports, or other proceeding
arising under or in respect to this chapter, irrespective of whether
proceedings with respect to the order have previously been insti-
tuted or become final under subsection (f) of this section. June
25, 1938, c. 675, § 701, 52 Stat. 1055; 1940 Reorg. Plan No. IV,
§ 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; June 25, 1948,
c. 646, § 32, 62 Stat. 991; 1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr.
11, 1953, 18 F.R. 2053, 67 Stat. 631; Apr. 15, 1954, c. 143, § 2, 68
Stat. 55; Aug. 1, 1956, c. 861, § 2, 70 Stat. 919; Aug. 28, 1958,
Pub.L. 85-791, § 21, 72 Stat. 948, July 12, 1960, Pub.L. 86-618,
Title I, § 103 (a) (4), 74 Stat. 398.
1.12a FEDERAL FOOD, DRUG, AND COSMETIC ACT-
REGULATIONS & HEARINGS
June 25,1938, P.L. 75-717, §701, 52 Stat. 1055
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 Agri-
culture shall jointly prescribe regulations for the efficient enforce-
ment 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
Agriculture 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.
(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)
and (b), 501 (b), 502 (d), 502 (h), 504, and 604. The Secretary
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STATUTES AND LEGISLATIVE HISTORY 1011
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 rea-
sonable 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 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
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.
(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,
[p.1055]
for a judicial review of such order. The summons and petition may
be served at any place in the United States. The Secretary,
promptly upon service of the summons and petition, shall certify
and file in the court the transcript of the proceedings and the rec-
ord on which the Secretary based his order.
(2) If the petitioner applies to the court for leave to adduce addi-
tional 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 Secre-
tary, 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, for the modification or setting aside of his original order,
-------
1012 LEGAL COMPILATION—PESTICIDES
with the return of such additional evidence.
(3) The court shall have jurisdiction to affirm the order, or to
set it aside in whole or in part, temporarily or permanently. If the
order of the Secretary refuses to issue, amend, or repeal a regula-
tion 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 findings of the
Secretary as to the facts, if supported by substantial evidence,
shall be conclusive.
(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 proceed-
ings 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). [p. 1056]
1.12a (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-
-------
STATUTES AND LEGISLATIVE HISTORY 1013
tisement of food, drugs, devices, and cosmetics, in interstate, for-
eign, and other commerce subject to the jurisdiction of the United
States, for the purposes of safeguarding the public health, pre-
venting deceit upon the purchasing public, and for other purposes,
having considered the same, report thereon with certain amend-
ments, 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.
This bill meets these three principles. It has been prepared after
many and extensive conferences with the enforcement agencies of
the Government and with representatives of various consumer
groups or associations, professional groups, and the industries to
be regulated.
Separately called meetings were held with representatives of the
food, drug, and cosmetic industries. Letters inviting suggestions
were sent to many persons known to be interested in the subject.
Several volumes of suggestions have been received from persons in
the groups just mentioned. These suggestions have been carefully
studied; many of them rejected; some accepted; some accepted in
part or in effect. The hearings which have been held by commit-
tees of the Senate and House of Representatives on previous bills
in former sessions of the Congress have been reviewed and studied
to take advantage of the information and discussions contained
in them.
[p.l]
ADVERTISING
1. Prohibits false advertising of food, drugs, therapeutic devices,
and cosmetics.
FOODS
2. Provides for the promulgation of standards of identity and a
reasonable standard of quality for food. (A standard of quality
is authorized by the present law for canned food only.)
3. Requires the labeling of unstandardized food to disclose the
ingredients by name.
4. Prohibits traffic in food which is dangerous to health. (The
present law permits regulation of dangerous food only in the
event that the poison is added.)
5. Prohibits addition of poison. If it cannot be avoided in pro-
-------
1014 LEGAL COMPILATION—PESTICIDES
duction or manufacture, when it reaches the consumer the product
must be safe for human use.
6. Eliminates the "distinctive name" proviso of the existing
law under which the sale of products, the labels of which are mis-
leading, are now permitted sale.
7. Requires fully informative labeling of infant and invalid
food.
8. Requires label declaration of artificial colors and artificial
flavors in food.
9. Forbids traffic in confectionery containing metallic trinkets
and other inedible substances which have been found to be a men-
ace to the welfare of children.
10. Authorizes emergency license control of food that might be
dangerous by reason of contamination with micro-organisms. Such
licensing is limited to operations in which the public health cannot
be protected otherwise.
COSMETICS
11. For the first time places cosmetics under Federal supervi-
sion. Requiring cosmetics to be truthfully sold and outlaws those
injurious to health.
DRUGS
12. Prohibits traffic in drugs and devices which are dangerous
to health under the conditions of use prescribed in the labeling" or
advertising.
13. Requires habit-forming drugs to bear warning labels.
14. Requires adequate directions for use of drugs and devices
and appropriate warnings against their probable misuse through
overdosage, or by children, or in disease conditions where they
may be dangerous.
[p. 5]
15. Sets up special protection to consumers against drugs liable
to deterioration.
16. Requires that claims of effect of drugs and devices must not
be false or misleading in any material particular. (The present
law makes fraud, that is, wilful intent to deceive, an element of
the offense; unwarranted therapeutic claims resulting from sheer
ignorance of the manufacturer are not actionable.)
17. Defines "nonofficial" drugs as illegal if the standard of
strength varies from the standard claimed. (The present law pre-
scribes only those which fall below the standard claimed. Drugs
which are too strong may be quite dangerous.)
18. Requires that antiseptics possess germicidal power.
-------
STATUTES AND LEGISLATIVE HISTORY 1015
19. Requires declaration on the label of the names of active
ingredients of nonofficial drugs.
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 rec-
ords needed to prove Federal jurisdiction.
25. Provides increased penalties for violations.
26. Authorizes the Federal courts to enjoin violations.
[p. 6]
1.12a (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, for-
eign, and other commerce subject to the jurisdiction of the United
States, for the purposes of safeguarding the public health, prevent-
ing deceit upon the purchasing public, and for other purposes, and
which was heretofore reported with certain amendments, submit
herewith an amended report and recommend that the bill, as
amended, 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
-------
1016 LEGAL COMPILATION—PESTICIDES
which is unnecessary or unjustified in the public interest.
This bill meets these three principles. It has been prepared after
many and extensive conferences with the enforcement agencies of
the Government and with representatives of various consumer
groups or associations, professional groups, and the industries to
be regulated.
Separately called meetings were held with representatives of the
food, drug, and cosmetic industries. Letters inviting suggestions
were sent to many persons known to be interested in the subject.
Several volumes of suggestions have been received from persons in
the groups just mentioned. These suggestions have been carefully
studied; many of them rejected; some accepted; some accepted in
part or in effect. The hearings which have been held by committees
of the Senate and House of Representatives on previous bills in for-
mer sessions of the Congress have been reviewed and studied to
take advantage of the information and discussions contained in
them. [p. 1]
ADVERTISING
1. Prohibits false advertising of food, drugs, therapeutic devices,
and cosmetics.
POODS
2. Provides for the promulgation of standards of identity and a
reasonable standard of quality for food. (A standard of quality is
authorized by the present law for canned food only.) In providing
a standard of identity for citrus fruit, it is intended that such will
be a standard of maturity only.
3. Requires the labeling of unstandardized food to disclose the
ingredients by name.
4. Prohibits traffic in food which is dangerous to health. (The
present law permits regulation of dangerous food only in the event
that the poison is added.)
5. Prohibits addition of poison. If it cannot be avoided in pro-
duction or manufacture, when it reaches the consumer the product
must be safe for human use.
6. Eliminates the "distinctive name" proviso of the existing
law under which the sale of products, the labels of which are mis-
leading, are now permitted sale.
7. Requires fully informative labeling of infant and invalid food.
8. Requires label declaration of artificial colors and artificial
flavors in food.
9. Forbids traffic in confectionery containing metallic trinkets
and other inedible substances which have been found to be a menace
to the welfare of children.
-------
STATUTES AND LEGISLATIVE HISTORY 1017
10. Authorizes emergency license control of food that might be
dangerous by reason of contamination with micro-organisms. Such
licensing is limited to operations in which the public health cannot
be protected otherwise.
COSMETICS
11. For the first time places cosmetics under Federal supervi-
sion. Requiring cosmetics to be truthfully sold and outlaws those
injurious to health.
DRUGS
12. Prohibits traffic in drugs and devices which are dangerous
to health under the conditions of use prescribed in the labeling or
advertising.
13. Requires habit-forming drugs to bear warning labels.
[p. 5]
14. Requires adequate directions for use of drugs and devices
and appropriate warnings against their probable misuse through
overdosage, or by children, or in disease conditions where they may
be dangerous.
15. Sets up special protection to consumers against drugs liable
to deterioration.
16. Requires that claims of effect of drugs and devices must not
be false or misleading in any material particular. (The present law
makes fraud—that is, willful intent to deceive—an element of the
offense; unwarranted therapeutic claims resulting from sheer igno-
rance of the manufacturer are not actionable.)
17. Defines "nonofficial" drugs as illegal if the standard of
strength varies from the standard claimed. (The present law pre-
scribes only those which fall below the standard claimed. Drugs
which are too strong may be quite dangerous.)
18. Requires that antiseptics possess germicidal power.
19. Requires declaration on the label of the names of active
ingredients of nonofficial drugs.
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.
-------
1018 LEGAL COMPILATION—PESTICIDES
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]
1.12a (3) HOUSE COMMITTEE ON INTERSTATE AND
FOREIGN 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 jurisdiction
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 recom-
mend 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. 1]
-------
STATUTES AND LEGISLATIVE HISTORY 1019
Section 701 relates generally to regulations. In the case of regu-
lations, the violation of which constitutes an offense, it is required
that appropriate notice of a public hearing be given and that
adequate time shall be given after the promulgation of a regulation
before it becomes effective.
PROCEDURE GOVERNING FORMULATION AND JUDICIAL REVIEW OF
REGULATIONS
Section 701 (e), (f), and (g) of the committee amendment set
forth the procedure governing the formulation and judicial review
of certain regulations to be issued by the Secretary. These regula-
tions include those with respect to the following matters: Estab-
lishing definitions and standards of identity, standards of quality,
and standards of fill of container for foods (sec. 401) ; information
on label concerning vitamin, mineral, and dietary properties of
foods (sec. 403 (j) ) ; limitations on quantity of added poisonous
or deleterious substances whose presence cannot be avoided by good
manufacturing practice (sec. 406 (a) ) ; issuance of temporary
permits governing manufacturing, processing, or packing so as
to prevent contamination with micro-organisms (sec. 404 (a) ) ;
prescribing appropriate tests on methods of assay to determine
[p. 9]
strength, quality, or purity of drugs (sec. 501 (b) ) ; designation
of drugs as habit-forming (sec. 502 (d) ); directions on label as to
use of drugs (sec, 502 (f) ) ; statements on label as to precautions
necessary by reason of liability of drug to deterioration (sec. 502
(h) ) ; and listing- of harmless coal-tar colors and certification of
batches thereof for food, drugs, or cosmetics (sees. 406 (b), 504,
and 604).
Such regulations are not merely interpretive. They have the force
and effect of law and must be obiserved. Their violation may result
in the imposition of criminal penalties, or in the confiscation of the
goods involved if shipped in interstate commerce, or in their exclu-
sion from the country if imported.
Hearings.—A proposal to issue, amend, or repeal any such regu-
lation is to be made by the Secretary of Agriculture on his own
initiative, or by the interested industry or a substantial portion
thereof, and the Secretary is required to set the proposal for hear-
ing. The proposal is to be set forth in general terms so that the
Secretary will be free to frame the precise language of the regu-
lation or amendment or repeal in the light of the evidence devel-
oped at the hearing.
As a result of the hearing on the proposal the Secretary may
determine to issue, amend, or repeal the regulation, or not to do so.
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1020 LEGAL COMPILATION—PESTICIDES
In either case, however, he is required to issue and make public an
order specifying the action taken. This will prevent the pocketing
of proposals to issue, amend, or repeal a particular regulation and
eliminate application of the "negative order" doctrine which denies
court relief where the executive officer merely fails to take any
affirmative action.
If as a result of the hearing on any proposal the Secretary deter-
mines to issue, amend, or repeal the regulation, the action taken
may be based only on substantial evidence of record at the hearing.
Similarly, the action of the Secretary in failing to carry into effect
any proposal for issuance, amendment, or repeal of a regulation
set for hearing must rest on a like basis. In either instance detailed
findings of the facts on which the action of the Secretary is based
are required to be made public as a part of his order. It follows
that if the order of the Secretary is to be valid, the Government
must have placed in the record at the hearing its evidence in sup-
port of the action taken and thereby afford opportunity for persons
affected to controvert viva voce the Government's evidence. While
common law or jury trial rules of evidence need not be enforced at
such hearing, nevertheless it is essential to such a hearing that all
the evidence on which the administrative officer acts be disclosed
at the hearing and that the right to controvert viva voce be accord-
ed. Cf. Ohio Bell Tel. Co. v. Public Utilities Comm. of Ohio (1937)
301 U.S. (preliminary print) 292.
The order of the Secretary is to take effect not earlier than 90
days after it is issued and made public, except that if the Secretary
finds that emergency conditions so require, and specifies in the
order his findings as to such conditions, then the order may take
effect at an earlier date.
Judicial review.—Judicial review of the order of the Secretary
with respect to any proposal for the issuance, amendment, or repeal
of a regulation may be had in a district court of the United States.
Such review may be had on the initiative of any individual or
business organization by instituting the special review proceedings
[p. 10]
provided in the committee amendment within 90 days after issu-
ance of the Secretary's order. The complainant can institute the
proceedings only in a case of actual controversy as to the validity
of the order, thereby meeting the constitutional requirement for
vesting in the Federal courts jurisdiction only of "cases" or
"controversies."
Such review proceeding is to be instituted by filing a complaint
in the district court for the district where the complainant resides
-------
STATUTES AND LEGISLATIVE HISTORY 1021
or has his principal place of business. The new Rules of Civil Pro-
cedure for the District Courts of the United States which will take
effect following the present session of Congress, will govern the
form of complaint, service of summons, and the like. There is one
exception. Personal service on the Secretary may be had anywhere
in the United States even though he is without the territorial limits
of the State in which the court is held.
In such special review proceeding the court will have jurisdiction
to enjoin the Secretary from enforcing the order if it is invalid
and may also compel him to issue an order providing for such regu-
lation, amendment, or repeal as will be in accordance with law if
justice requires that such affirmative action be taken.
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 valid-
ity of the regulation or order could be inquired into and deter-
mined in such criminal, injunction, libel for condemnation, exclu-
sion of imports, or other proceeding.
There is also saved as a method to review a regulation placed in
effect by the Secretary whatever rights exist to initiate a historical
proceeding in equity to enjoin the enforcement of the regulation,
and whatever rights exist to initiate a declaratory judgment
proceeding.
The special type of review above outlined, where the proceedings
are instituted by the individual or business organization affected,
will permit an early determination of the validity of the Secretary's
action with respect to any proposal for a regulation, amendment,
or repeal, and make for prompt certainty as to legal rights.
In each of the types of review proceeding above outlined the tran-
script of the record and proceedings before the Secretary on the
proposal resulting in the order, may become a part of the evidence
in the court. In the special review proceedings the Secretary is
required to certify and file the transcript in the court. In the other
cases, a certified copy of the transcript is required to be furnished
by the Secretary and is admissible in court. The special review pro-
visions also specifically provide that the court is to permit the pri-
-------
1022 LEGAL COMPILATION—PESTICIDES
vate individual or concern to supplement the evidence in such
transcript by adducing additional evidence (which the Secretary
may rebut) bearing on the validity of the order, but only on a
showing that such additional evidence is material and that there
were reasonable grounds for failure to adduce it before the Secre-
[p. 11]
tary. While this right to adduce additional evidence inheres in the
criminal and libel proceedings originating in court, specific pro-
vision is made for it in the committee amendment in connection
with the special review proceedings. The additional evidence could
be taken before the court or a master, or, in the case of the special
review proceeding, the court may remand the case to the Secretary
for the taking of such evidence if the court deemed that desirable
because of the amount of such evidence or its technical character,
or in order to permit the Secretary to amend his order in the light
of such additional evidence, or for any other reason.
The committee amendment is silent as to any limitations on the
court in holding invalid the order of the Secretary. The court is
thus left free to exercise its right of review to the full extent that
it may constitutionally do so. A regulation would, of course, be
invalid if the Secretary failed to observe the procedural require-
ments as to hearing, notice, and the like, or if the order, as specifi-
cally required by the committee amendment, was not based on sub-
stantial evidence of record at his hearing, or went beyond or was
contrary to the Secretary's own finding, or to constitutional or
jurisdictional limitations. Furthermore, the order would be invalid
if for any other reason it was not in accordance with law. The court
can take into consideration the additional evidence, if any, adduced
before it, and to the extent that it may constitutionally do so, weigh
the combined evidence, and hold the order invalid if in the light of
such evidence it appears that the findings on which the Secretary
based the order are not true in fact or that the order is unreason-
able, arbitrary, or capricious. [p- 12]
PART 2
FOOD, DRUG, AND COSMETIC ACT
APKIL 21,1938.—Ordered to be printed
Mr. CHAPMAN, from the Committee on Interstate and Foreign
Commerce, submitted the following
MINORITY VIEWS
[To accompany S. 5]
The undersigned, members of the Committee on Interstate and
Foreign Commerce, submit the following minority views with res-
-------
STATUTES AND LEGISLATIVE HISTORY 1023
pect to one of the most important features of the bill, namely, pro-
visions for court review of regulations of section 701 (f).
It is our view that the bill, if enacted with this review provision,
will not afford any substantial improvement in consumer protection
over the terms of the present law. In fact, in some respects it rep-
resents an impairment of the consumer-protective features of the
present law.
Section 701 (f) sets up a method of court review of regulations
that is wholly unprecedented. It is specifically provided that this
method of review is in addition to, and not in substitution for, other
methods of review provided by law, such as equity proceedings and
proceedings under the Declaratory Judgment Act.
Regulations subject to this new form of review relate to the iden-
tity and quality of food; to requirements for informative labeling
of special dietary food, such as that used by infants and invalids;
to food contaminated with disease organisms where distribution
might result in serious epidemics; to the addition of poisons to food;
to the certification of coal-tar colors for use in foods, drugs, and
cosmetics; to establishing adequate laboratory tests for important
official drugs; to the listing of narcotic and habit-forming drugs;
to label warnings against probable misuse of dangerously potent
drugs; and to label directions for the preservation of potent drugs
liable to deterioration.
These provisions constitute the very heart of any worthy food
and drug legislation. If the public health and welfare are to be ade-
quately safeguarded, regulations putting these provisions into
effect should be promptly and effectively enforceable and certainly
should be subject to no greater restrictions and delays in review
by the courts to determine their validity than regulations autho-
rized by other Federal laws which deal with economic questions
[p.l]
rather than the vital questions of public health concerned in this
legislation.
Section 701 (f) permits any person who will be adversely affect-
ed by one of the regulations listed above to file, any time within
90 days after the regulation has issued, a complaint in the district
court for the district where such person resides or has his principal
place of business to enjoin the Secretary of Agriculture from
enforcing the regulation. For example, if a regulation is issued
requiring label warnings against probable and dangerous misuse
of a certain class of patent medicine, then each manufacturer of
that class of medicines and each dealer who profits by the sale of
the medicines may file a complaint in his local district court to
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1024 LEGAL COMPILATION—PESTICIDES
enjoin the enforcement of the regulation. If a single district judge
could be found who would issue an injunction against such enforce-
ment, the regulation could not be enforced at any place in the
United States, even though every other district judge in the coun-
try had refused to issue an injunction. The provision would there-
fore clothe each and every district judge with authority to block
the enforcement of a regulation throughout the United States.
This is an extraordinary extension of jurisdiction and an extraor-
dinary grant of power never heretofore seriously advanced in the
entire history of the country. As suggested in the letter of the Sec-
retary of Agriculture, a copy of which is hereto attached, if there
is to be an exploration into new forms of court review of administra-
tive regulations specifically authorized by congressional enact-
ment, it is our conviction that such experimentation should be made
in fields other than those of vitally important health laws.
Even if the injunction which blocks the enforcement of a regu-
lation can be overturned in appellate courts, there is a provision
under the preceding subsection (701 (e) ) whereby the question
can be reopened and the regulation again subjected to the same
hazards. This provision requires that—
the Secretary, on his own initiative, or at the request of any interested indus-
try or substantial portion thereof, shall hold a public hearing upon a proposal
to issue, amend, or repeal any regulation * * * [Italics supplied.]
If the manufacturers of the class of patent medicines referred
to above, or any substantial proportion of such manufacturers,
demanded a public hearing on a proposal to amend or repeal a
regulation previously validated by the courts after litigation under
subsection (f), the Secretary would have no alternative but to
hold such a hearing and to follow the prescribed procedure laid
down by subsection (e) under which he would issue an order con-
taining the regulation in effect. The continuation of the regulation
by such order would then become subject within the 90-day period
prescribed, to the filing of a second crop of complaints throughout
the United States. If a single district judge could again be found to
issue an injunction, the regulation would again be rendered
ineffective.
In most of the industries affected by the bill there are sufficient
minorities, vociferously opposed to any form of regulation, to
form a substantial proportion of the industry. These could be
depended upon in practically every instance in which a regulation
is required for the protection of public welfare to resort to the tac-
tics above described and prevent indefinitely the effectuation of
the purpose of the law. [p. 2]
The procedure set up in the bill to restrain the Secretary, while
-------
STATUTES AND LEGISLATIVE HISTORY 1025
in form only seeming to protect industry rights, in effect amounts
to the placing of the control of enforcement in the hands of those
whose interests are contrary to public welfare and who have cre-
ated the need for legislation.
It is true that the scope of the old law is broadened by the bill to
include cosmetics, therapeutic devices, and certain drugs which are
not now subject to regulation. It is true that in many instances
the definitions of adulteration and misbranding have been
expanded and strengthened, although even these improvements
are studded with a notable number of exceptions. It is also true
that the procedural provisions have been strengthened through
authorization of injunction proceedings, although this, to some
extent, is nullified by changes from the seizure section of the
existing law, particularly that under which trial of seizure cases
will in many instances occur in producing jurisdictions before
juries whose sympathies would ordinarily be with local industries
rather than in consuming jurisdictions where juries would be
expected to display less bias.
Weighing the advantages and disadvantages for the protection
of consumer welfare presented by the terms of this bill, we are
unable to escape the conclusion that because of the extraordinary
provision for court review of regulations in section 701 (f), which
would postpone indefinitely the consumer protection that can now
be afforded in some degree by the present law in much of the field
to be covered by these regulations, it would be better to continue
the old law in effect than to enact S.5 with this provision.
If there is to be exploration into new methods of court review,
such a radical departure from the well-established Federal pro-
cedure as is here proposed should be the subject of a separate bill,
applicable to all Federal laws authorizing regulations, to be con-
sidered on its own merits. This important health legislation should
not be made the sole medium for such experimentation.
Under date of March 28, 1938, the undersigned [Chapman and
Mapes] submitted the then latest draft of section 701, the court-
review section, of the bill to the Secretary of Agriculture and asked
for his views in regard to the same.
The following is a copy of his reply:
Hon. GAEL E. MAPES, MAKCH 29>1938-
House of Representatives.
MY DEAR MR. MAPES: Receipt is acknowledged of your letter of March 28,
1938, with which you enclose a copy of chapter VII, General Administrative
Provisions, section 701, from the latest edition of S. 5 as agreed upon by the
Interstate and Foreign Commerce Committee of the House. You ask for an
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1026 LEGAL COMPILATION—PESTICIDES
expression of my opinion of the effect of the provisions of this section upon the
administration of the measure.
I am of the opinion that if section 701 (f) remains in the bill its effect will
be to hamstring its administration so as to amount to a practical nullification
of the substantial provisions of the bill.
The clear intent of S. 5 is to close the channels of interstate commerce to
food, drugs, devices, and cosmetics that are adulterated or misbranded. Because
of the complex and technical nature of the subject matter involved a nu,mber
of the most important definitions of adulteration and misbranding are incom-
plete and must have their clearly stated outlines filled in with scientifically
accurate details before they can be enforced. The bill delegates to the Secre-
tary of Agriculture the quasi-legislative power to ascertain the necessary
technical facts and supply the details that will complete these definitions, thus
effectuating the legislative will. [p. 3]
The Secretary is entrusted with these powers in connection with sections
401, 403 (j),404 (a), 406 (a) and (b), 501 (b), 502 (d), 502 (f) exclusive of
the proviso, 502 (h), 504, and 604. These sections are extremely important.
They relate to the identity and quality of food, to requirements with respect to
special dietary food, to contaminated food, to poisonous substances in food, to
coal-tar colors in food, drugs, and cosmetics, to determining adequate tests
for official drugs, to narcotics and habit-forming drugs, to probable misuse of
dangerously potent drugs, and to labeling drugs liable to deterioration.
Section 701 (f) permits any person who will be adversely affected by any
order authorized by the sections listed above to file, any time within 90 days
after the issuance of the order, a complaint in the district court for the district
where such person resides or has his principal place of business, to enjoin the
Secretary from placing the order in effect. This subsection contains the unique
provision directing the courts to permit the complainant to supplement the
evidence recorded in the Secretary's hearing upon which the order was based.
This constitutes an invitation to those who would obstruct the enforcement of
a regulation to withhold or conceal evidence that should have been given in
the hearing and to employ such evidence merely for the purpose of upsetting
the order and thus postponing indefinitely the enforcement of the regulation. In
the event such order is upset there is nothing to prevent the same complainant
from instituting new proceedings on a new order and thereby causing further
delay. In fact, every amendment of an order could be a ground for the institu-
tion of new proceedings.
Even though a number of district courts might uphold an order, demanded
alike by the public and by the overwhelming majority of the industry regu-
lated, to terminate abusive practices, a single district court could enjoin per-
manently the enforcement of the regulation.
Frankly, I regard this provision as unfair to the Department, to the public,
and to the industries regulated, the majority of which unquestionably would
support regulations, based on substantial evidence, which the Secretary of
Agriculture would promulgate. It would constitute a serious impediment to
orderly administrative operations. If a bill containing this provision were
enacted it would not constitute any material contribution to the public protec-
tion that the Department cannot now extend under the existing law. In some
respects it would afford even less protection than that afforded by the existing
law, which is broad and general in its terms and is to some degree applicable
and effective in the fields covered by the sections involved in this discussion.
It is the Department's considered judgment that it would be better to con-
-------
STATUTES AND LEGISLATIVE HISTORY 1027
tinue the old law in effect than to enact S. 5 with this provision.
If there is to be exploration into new fields of administration law, may I
urge that it not be in the field of vitally important public health legislation.
There has not been sufficient time to permit the Department to ascertain the
relation of the foregoing to the program of the President.
Sincerely yours, H. A. WALLACE, Secretary.
Attention is called especially to the following statements in the
letter of the Secretary:
I am of the opinion that if section 701 (f) remains in the bill its effect
would be to hamstring its administration so as to amount to a practical nulli-
fication of the substantial provisions of the bill.
It is the Department's considered judgment that it would be better to
continue the old law in effect than to enact S. 5 with this provision.
If there is to be exploration into new fields of administrative law, may I
urge that it not be in the field of vitally important public health legislation.
The section as submitted to the Secretary of Agriculture was the
same as the section as reported by the majority of the committee,
except in two particulars, one of which weakens the enforcement
provision of the section, the other of which has no effect on it one
way or the other, in our opinion.
The committee amended the draft of the section as submitted to
the Secretary, (1) by striking out of the committee substitute,
page 82, line 19, after the word "shall", the words "if in his judg-
ment sufficient reason appears for so doing"; and (2) by inserting,
page 84, line 8, after the word "shall", the words "upon the show-
[p-4]
ing that such additional evidence is material and that there were
reasonable grounds for failure to adduce such evidence at the pro-
ceeding before the Secretary."
As stated, the first amendment weakens the enforcement provi-
sion of the section. The second one requires nothing more than a
court would ordinarily require without it.
If this bill is enacted into law with section 701 (f), the court-
review section, in it, as reported by a majority of the committee,
what started out as an effort on the part of the advocates of a more
adequate food and drug law to enlarge the scope of the existing
law, to fill in the loopholes in it, and to put more teeth into it, will
end with having accomplished the directly opposite result and
years of earnest effort will have gone for worse than naught.
VIRGIL CHAPMAN,
JERRY J. O'CONNELL,
CARL E. MAPES,
CHAS. A. WOLVERTON,
JAMES WOLFENDEN,
PEHR G. HOLMES, r 5-|
-------
1028 LEGAL COMPILATION—PESTICIDES
1.12a (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
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 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
amendment insert the following:
Chapter I—Short Title
Section 1. This Act may be cited as the Federal Food, Drug, and
Cosmetic Act.
Chapter II—Definitions
*******
[p.l]
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 Agricul-
ture shall jointly prescribe regulations for the efficient enforce-
ment 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 Agri-
culture shall determine.
-------
STATUTES AND LEGISLATIVE HISTORY 1029
(c) Hearings authorized or required by this Act shall be con-
ducted by the Secretary or such officer or employee as he may des-
ignate 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
[p. 16]
the United States and regulations promulgated thereunder.
(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 Secre-
tary shaU 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 hear-
ing on regulations under section 404 (a) may be held within a rea-
sonable 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 hear-
ing, 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 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.
(f) (1) In a case of actual controversy as to the validity of any
order under subsection (e), any person who will be adversely affec-
ted 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 Cir-
cuit 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. The summons and petition may be
served at any place in the United States. The Secretary, promptly
upon service of the summons and petition, shall certify and file in
-------
1030 LEGAL COMPILATION—PESTICIDES
the court the transcript of the proceedings and the record on which
the Secretary based his order.
(2) If the petitioner applies to the court for leave to adduce addi-
tional 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 Secre-
tary, 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,
for the modification or setting aside of his original order, with the
return of such additional evidence.
(3) The court shall have jurisdiction to affirm the order, or to
set it aside in whole or in part, temporarily or permanently. If the
order of the Secretary refuses to issue, amend, or repeal a regula-
tion 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 findings of the Sec-
retary as to the facts, if supported by substantial evidence, shall
be conclusive. [p. 17]
(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 certio-
rari or certification as provided in sections 239 and 240 of the
Judicial Code, as amended.
(5) Any action instituted under this subsection shall survive not-
withstanding any change in the person occupying the office of Sec-
retary or any vacancy in such office.
(6) The remedies provided for in this subsection shall be in addi-
tion to and not in substitution for any other remedies provided
by law.
(g) A certified- copy of the transcript of the record and proceed-
ings 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 condemnation,
exclusion of imports, or other proceeding arising under or in re-
spect to this Act, irrespective of whether proceedings with respect
to the order have previously been instituted or become final under
subsection (f).
[p. 18]
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STATUTES AND LEGISLATIVE HISTORY
1031
1.12a (5) CONGRESSIONAL RECORD
1.12a (5) (a) VOL. 81 (1937), March 9: Amended and passed Sen-
ate, p. 2019
[No Relevant Discussion on Pertinent Section]
1.12a (5) (b) VOL. 83 (1938), June 1: Amended and passed House,
pp. 7891-7899
Mr. MAPES. Mr. Chairman, I offer
an amendment, which I send to the
Clerk's desk.
The Clerk read as follows:
Amendment offered by Mr. MAPES: Page 83,
line 20, strike out all of paragraph (f), section
701, and insert the following:
"(f) 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 obtain a re-
view of such order in the circuit court of ap-
peals of the United States within any circuit
where such person resides or carries on busi-
ness by filing in the court, within 60 days from
the date of such order, a written petition pray-
ing that the order of the Secretary be set aside.
A copy of such petition shall be forthwith
served upon the Secretary, and thereupon the
Secretary shall certify and file in the court a
transcript of the entire record in the proceed-
ing, including all the evidence taken and the
report and order of the Secretary. Upon such
filing of the petition and transcript the court
shall have jurisdiction of the proceeding and of
the question determined therein, and shall have
power to make and enter upon the pleadings,
evidence, and proceedings set forth in such
transcript a decree affirming, modifying, or
setting aside the order of the Secretary. The
findings of the Secretary as to the facts, if sup-
ported by evidence, shall be conclusive. If either
party shall apply to the court for leave to ad-
duce additional evidence and shall show to the
satisfaction of the court that such additional
evidence is material and that there were rea-
sonable grounds for the failure to adduce such
evidence in the proceedings before the Secre-
tary, the court may order such additional evi-
dence to be taken before the Secretary and to
be adduced upon the hearings in such manner
and upon such terms and conditions as the court
may deem proper. The Secretary may modify
his findings as to the facts, or make new find-
ings, by reason of the additional evidence so
taken, and he shall file such modified or new
findings, which, if supported by evidence, shall
be conclusive, and his recommendation, if any,
for the modification or setting aside of his
original order, with the return of such addi-
tional evidence. The judgment and decree of the
court shall be final, except that the same shall
be subject to review by the Supreme Court
upon certiorari, as provided in section 240 of
the Judicial Code."
Mr. MAPES. Mr. Chairman, I ask
unanimous consent to proceed for 5
additional minutes.
The CHAIRMAN. Is there objection
to the request of the gentleman from
Michigan?
There was no objection.
Mr. MAPES. Mr. Chairman, it is
unfortunate to have to consider an
amendment of this importance with so
few Members on the floor. Several
months ago the Committee on Inter-
state and Foreign Commerce, which re-
ported the pending committee substi-
[p.7891]
tute, brought in a bill to amend the
Federal Trade Commission Act. The
amendment which I have offered is
the same as the court review section in
the Federal Trade Commission Act
with only such changes as are neces-
sary to adapt it to the pending bill.
In substance my amendment is identi-
cal with the provision reported by the
Committee on Interstate and Foreign
Commerce relating to the Federal
Trade Commission, except that it ap-
plies to the Food and Drug Administra-
tion instead of the Federal Trade
Commission. I referred yesterday to
similar provisions in the acts relating
to other regulatory bodies. At that
time I did not have before me this act
relating to the Federal Trade Com-
mission. As I said yesterday, nowhere
is there any law that I know of hav-
ing to do with a regulatory body that
is comparable or similar to the provi-
sion contained in the pending bill. This
legislation started out to enlarge the
scope of the food and drug law and
-------
1032
LEGAL COMPILATION—PESTICIDES
the jurisdiction of the Food and Drug
Administration, but if this section re-
mains in the bill it will end up by ma-
terially weakening and limiting the
authority of the Food and Drug Ad-
ministration.
The chairman of the Committee on
Interstate and Foreign Commerce yes-
terday stated that the minority report
was unfair and unwarranted, in that
it quoted a letter of the Secretary of
Agriculture with reference to this leg-
islation. When did it become unfair or
unwarranted to let the membership of
the House know what the views of the
head of a great department are in re-
gard to legislation affecting one of the
principal bureaus of his department?
I find myself in the position of trying
to sustain, as against the majority of
the committee, the views of not only
the Department of Agriculture, but the
Department of Justice as well, with
reference to this legislation.
I hold in my hand a memorandum
which was prepared by the Department
of Justice with reference to this bill.
I may say it was not prepared for me
or at my request. However, I have been
authorized over the telephone to say
that it was prepared in the Depart-
ment of Justice and expresses the views
of that Department in regard to some
of the provisions of this bill.
I shall read extracts from it and put
the rest of it in the RECORD without
taking the time to read it. It is as
follows:
RE S. 5 PURE FOOD AND DRUG BILL
Section 701 (f), which relates to judicial re-
view of the orders of the Secretary of Agricul-
ture by means of injunction suits in the United
States district courts, constitutes a radical and
undesirable departure from established practice.
This section provides that any person ad-
versely affected by any such order may bring
an injunction suit against the Secretary of Agri-
culture in the district wherein such person re-
sides or has his principal place of business.
The consequence of such grant of jurisdiction
would be to subject the Secretary to the possi-
bility of injunction suits by different parties in
85 different districts to review the validity of
the same order. The Secretary conceivably might
be required to defend simultaneously numerous
suits in as many aa 85 jurisdictions.
Now, listen to this:
Not only would this result in an intolerable
burden on the Government, in that Govern-
ment attorneys, Department of Agriculture ex-
perts, Government flies, laboratory specimens,
etc., would have to be carried from district to
district, but divergence of decisions might re-
sult which would tie up enforcement for months
and even years until the conflict of decisions
is ironed out by a series of decisions of the cir-
cuit courts of appeals or by a decision of the
Supreme Court of the United States. The ulti-
mate result would he to seriously hamper and
weaken the enforcement of the Pure Food and
Drug Act.
Under existing law, heads of Government De-
partments are suable only in the District of
Columbia, because the District of Columbia is
regarded as their official residence.
Do the members get that? Under ex-
isting law, heads of Government De-
partments are suable only in the Dis-
trict of Columbia.
No reason appears for extending preferen-
tial treatment in that respect to litigants under
the Pure Food and Drug Act, which is not ex-
tended to litigants against heads of other Gov-
ernment Departments or to litigants who sue
the Secretary of Agriculture under other statutes.
That is not my language. It is the
language of the Department of Justice.
The memorandum continues:
If the long-standing and established practice
is followed, persons who feel aggrieved at an
order of the Secretary of Agriculture, and de-
sire a judicial review of the validity of his
action, should be required to pursue their reme-
dy in the District Court of the United States
for the District of Columbia. In that way not
only would the Government be saved the in-
tolerable burden above mentioned but a diver-
sity of decisions would be prevented, and a final
determination could be expeditiously secured
in a single jurisdiction as to the validity of an
order of the Secretary. In this way the citizen
would have his day in court and would be ac-
corded the full and complete right of judicial
review of the validity of an administrative order
or regulation. At the same time interference
with enforcement of administrative orders and
regulations, and the orderly conduct of govern-
mental business would be reduced to a mini-
mum.
It is, therefore, suggested that it this sub-
section is to remain in the bill, it should be
amended by striking the words "for the district
wherein such person resides or has his princi-
pal place of business" from page 83, line 26,
to page 84, line 1, of the bill, and substituting
in lieu thereof "for the District of Columbia."
And now listen to this, and this
again is the language of the legal De-
-------
STATUTES AND LEGISLATIVE HISTORY
1033
partment of the Government, the De-
partment of Justice. I tried to make
this clear yesterday, and I am glad to
be substantiated by the Department of
Justice.
As a matter of fact, the entire subsection is
really unnecessary, because even without any
express provision in the bill for court review,
any citizen aggrieved by any order of the Sec-
retary, who contends that the order i« invalid,
may test the legality of the order by bringing
an injunction suit against the Secretary, or
the head of the Bureau, under the general
equity powers of the court.
The memorandum then discusses an-
other section of the bill. While that
part of the memorandum is not perti-
nent to my amendment, I will incorpo-
rate it in the RECORD. It is as follows :
Sections 304 (a) and (b) which relate to
seizure, contain provisions under which the
owner of the article libeled by the Department
of Agriculture may secure under certain cir-
cumstances a change of venue at his option. No
such privilege, however, is accorded the Govern-
ment. Why a defendant should be extended the
option of choosing in what jurisdiction he
should be sued, and yet the Government should
be precluded from making a selection of the
district in which suit should be brought, appears
to be inexplicable.
It should be noted that under the Federal
judicial system, changes of venue are unknown.
There are no provisions in Federal statutes
permitting either party to move for a change
of venue. No reason appears for introducing
this remedy in respect to one type of proceed-
ings under a special statute. Moreover, if the
remedy is to be accorded at all, it should be
equally available to both parties.
Specifically, sections 304 (a) and (b) provide
that if two libels are pending involving the
same person and the same issues, in two or more
districts, the claimant may require that the pro-
ceedings be consolidated for trial ard tried in
any one of such districts which is selected by
him. Why should not the selection be made by
the Government, which is the plaintiff in the
libel proceedings ?
The section further provides that the trial
in such cases may also be had in a district in a
State contiguous to the State of the claimant's
principal place of business, such district to be
agreed upon by stipulation or to be designated
by the court. In other words, under the second
alternative, the claimant in a series of libel
proceedings may insist on having all the libels
transferred to one district, and at that a dis-
trict in which none of them is pending, so
long as such district is contiguous to the State
of the claimant's principal place of business.
No reason appears for according to the owner
of articles charged with being in violation of
the Pure Food and Drugs Act, the right to
select the forum in which the issues shall be
determined.
It is suggested, therefore, that section 304 (a)
be amended by entirely striking therefrom the
clause beginning with the word "and" on line
14, page 53, and ending with the end of the
subsection ; and that section 304 (b) be amended
by entirely striking therefrom lines 4-21, in-
clusive, on page 54 of the bill.
Then the Department of Justice con-
cludes:
It is important to observe that the provisions
to which objection is made are not limited to
the new powers proposed to be granted to the
pending bill.
It would seem as if the writer of the
minority report, which the chairman of
the committee says is unwarranted and
unfair, might have had some consulta-
tion with the Department of Justice
before drafting the report. Let me as-
sure you, however, that he did not have
any such consultation.
The Department of Justice says, I
repeat—
It is important to observe that the provisions
to which objection is made are not limited to
the new powers proposed to be granted by the
pending bill. They would affect the enforce-
ment of the present law, as well as of the new
law, and therefore, are particularly undesir-
able in that they may undermine, hamper, and
weaken the entire enforcement of the Pure
Food and Drugs Act.
[p.7892]
The Secretary of Agriculture states
the enactment of this section would
hamstring the Department in the en-
forcement of the Food and Drugs Act.
The Department of Justice memo-
randum closes with this statement:
While undoubtedly this ia not the intention,
unfortunately, it may be the result of the enact-
ment of the bill in ita present form.
Why should the Food and Drug Ad-
ministration, among all the regulatory
bodies of the Government, be singled
out for special treatment and, in the
language of the Secretary of Agricul-
ture, be hamstrung in its enforcement
of food and drugs laws providing for
the protection of the health and the
well-being of the consuming public—
the men, women, and children of the
-------
1034
LEGAL COMPILATION—PESTICIDES
United States? Why should the Food
and Drug Administration be put on
trial? Why one rule for other regula-
tory bodies and another for the Food
and Drug Administration?
Perhaps the apple growers have been
overemphasized in this debate. They
are not the only ones affected by this
law. The law applies to proprietary
patent medicines, to impure and adul-
terated foods and drugs of all kinds,
and to cosmetics and devices. Is the
House ready to weaken the administra-
tive efficiency of the Food and Drug
Administration in all its regulatory
work merely to satisfy the complaints
of the apple growers? If this bill ap-
plied only to apple growers perhaps
this section would not be so objection-
able, but it applies to all violators of
the food and drugs law or to all who
come within its provisions. As the Sec-
retary of Agriculture states in his let-
ter which is printed in the minority
report, the enactment of this section
as it stands will hamstring the Food
and Drug Administration in the en-
forcement of the entire law.
Mr. ROBERTSON. Mr. Chairman,
I rise in opposition to the amendment.
Mr. Chairman, I do not intend to
enter into any elaborate discussion of
this amendment. The effect of the
amendment is simple. It makes a de-
partmental order supreme and denies
to those affected a day in court. It
makes it virtually impossible for any
user of a spray material for fruit or
vegetables to test in court the reason-
ableness of a departmental order af-
fecting residue tolerance.
The amendment seeks to accomplish
this in two ways. In the first place, it
provides that if there be any evidence
whatever, regardless of how inconse-
quential or flimsy it may be, to support
the findings of the Department of Ag-
riculture, such evidence becomes con-
clusive and binding upon the court.
You do not have any hearing on the
facts under this amendment. Of course,
the Department would have some evi-
dence, but our position is that it should
be evidence that is substantial and
that, in the opinion of a reasonable
court, would justify the court in up-
holding the order of the Department
that issued it.
The second provision of this amend-
ment—and I could not follow my friend
fully on this, but I understood him to
say yesterday he wanted to bring all
these cases to the District of Colum-
bia. I now understand that some cases
could be heard in the circuit court of
appeals of the State in which they
arose, but if the question at issue is
Nation-wide in its effect, it still has to
come to the District of Columbia.
Mr. MAPES. Mr. Chairman, will the
gentleman yield?
Mr. ROBERTSON. I yield.
Mr. MAPES. As I said in answer to
an interruption, I have gone more than
half way to meet the views of the Com-
mittee on Interstate and Foreign Com-
merce as expressed in the recent bill
which the committee reported relating
to the Federal Trade Commission.
Mr. ROBERTSON. Mr. Chairman,
this court-review section has been pro-
vided in the Senate bill, and I feel that
I am justified in stating to the House
that this bill will be enacted into law
by the Senate without it. This court-
review section is approved by a major-
ity of the committee that brings this
bill to us. It has the support of every
apple organization in the United States.
It has the support of all the organiza-
tions representing the production of
any type of fruit or vegetable where
spray must be used in the production.
If we adopt this amendment we will
leave thousands and thousands of
farmers in this Nation who must de-
pend upon the reasonableness of de-
partmental regulations with respect to
spray residue to keep their products
on the market at the mercy of the De-
partment. We have had an illustration
within the past five years of what
-------
STATUTES AND LEGISLATIVE HISTORY
1035
might happen to them. Dr. Tugwell,
Acting Secretary in the absence of the
Secretary of Agriculture, in misguided
enthusiasm to protect the public health,
well meaning but ignorant of what was
involved, promulgated a tolerance as
to lead residue that was nearly 100
percent below the then existing toler-
ance. It would have put every apple
producer in the United States out of
business. It was so capricious and so
unreasonable that as soon as the Sec-
retary got back and considered the
matter he reversed it and restored the
previous tolerance. That happened
once. It could happen again; and under
the amendment proposed by our dis-
tinguished colleague from Michigan
fruit and vegetable raisers could be
destroyed without a day in court. I do
not believe for a minute this House will
vote to subject the farmers of this
Nation to any such hazard at a time
when we all know they are not making
both ends meet. [Applause.]
[Here the gavel fell.]
[p.7893]
Mr. MAPES. Mr. Chairman, it pro-
vides in the first place that anyone who
desires to test the validity of a regu-
lation or order of the Food and Drug
Administration, instead of being per-
mitted to go into any district court of
the United States, must go before a
circuit court of appeals within the
district in which he resides. The hear-
ing would then come up before a three-
judge court instead of a one-judge
court. The action would be confined to
10 circuits instead of to 85 districts.
The amendment also contains the usual
provision, that the court is bound by
the findings of fact of the Food and
Drug Administration if supported by
substantial evidence, or evidence, and
if new evidence is discovered after the
hearing, then the court, instead of
opening the case and taking the testi-
mony itself, must remand the case to
the Food and Drug Administration to
take the additional evidence. That is
the usual provision.
Mr. VOORHIS. What about injunc-
tions under the gentleman's amend-
ment?
Mr. MAPES. The injunction matter
is outside of both of these provisions.
The injunction remedy by any ag-
grieved person is had without refer-
ence to the provisions in the bill or to
my amendment.
Mr. VOORHIS. I thank the gentle-
man.
Mr. COFFEE of Washington. Mr.
Chairman, will the gentleman yield?
Mr. VOORHIS. Yes.
Mr. COFFEE of Washington. Sec-
tion 701 (f) which is involved in this
dispute at the present time is the one
to which the leading women's clubs and
consumers' organizations in America
are offering objection, is it not?
Mr. VOORHIS. So I understand.
Mr. COFFEE of Washington. Every
organization of which I know anything
that has made a study of this question
is bitterly opposed to section 701 (f).
Mr. THOMAS of Texas. Mr. Chair-
man, will the gentleman yield?
Mr. VOORHIS. Yes.
Mr. THOMAS of Texas. To ask a
question of our colleague from Michi-
gan [Mr. MAPES]. Under section 701
(f) of the bill, suppose a manufacturer
is making improperly some type of
food or drug, and persisted in that dis-
tribution. How long would it take un-
der that procedure before the Govern-
ment could really stop him from using
the channels of interstate commerce?
Mr. MAPES. I do not know that I
can answer that question.
Mr. VOORHIS. We have had some
experience, I believe, with other types
of legislation.
Mr. LEA. Mr. Chairman, will the
gentleman yield?
Mr. VOORHIS. Certainly, I yield to
the chairman of the committee.
Mr. LEA. Under this bill the Gov-
ernment can act in that case within 24
hours.
Mr. THOMAS of Texas. The Gov-
ernment can act within 24 hours, but
-------
1036
LEGAL COMPILATION—PESTICIDES
how effectively can it act within a year
even?
Mr. LEA. It can stop the circulation
of it in 24 hours, because under this
bill we give the Food and Drug Admin-
istration the right to an injunction to
stop it immediately.
Mr. THOMAS of Texas. And that
injunction remains in effect until it
goes through the regular routine of
court procedure ?
Mr. LEA. We give that power to the
Food and Drug Administration in ev-
ery case, practically, that is involved
here.
Mr. THOMAS of Texas. And it stops
right there?
Mr. LEA. Yes, absolutely; and that
is a new power we give, by the way.
Mr. VOORHIS. Mr. Chairman, as I
understand the provisions of section
701 (f) it would mean that if one dis-
trict court was willing to issue an in-
junction holding up an order of the
Secretary under this bill, that that
would mean that that order could not
go into effect regardless of how serious
or important the provision was, and
because it avoids that possibility, it
seems to me, that the amendment of
the gentleman from Michigan is a
worthy one, and should be supported. I
believe we have had experience with
other types of legislation, where we
have seen an endless amount of litiga-
tion take place, where we have seen
the machinery hung up over long per-
iods if time. This is a matter where we
are attempting to get effective regula-
tion for the protection of the health of
the people, and I would hope, as was
said by the gentleman from Michigan,
that we would not have to hamstring
the Administration in that fashion. I
call the attention of the House also to
the fact that no such provision as this
is in existing law, that this is a new
departure and that it further compli-
cates the situation over what we have
now, and that if we wish to strengthen
the Food and Drug Administration, we
should not take the step of writing sec-
tion 701 (f) in the bill.
The CHAIRMAN. The time of the
gentleman from California has ex-
pired.
*****
Mr. ROBERTSON. Because he does
not get a hearing in the courts on the
facts but only on the law; yet the Gov-
ernment in its prosecution of those
cases where residue tolerances have
been exceeded have never thus far
proven a case where spray residue has
been injurious to the human body.
Mr. SAUTHOFF. That is not the
question. The question here involved
is the remedy, and the remedy exists if
I am not mistaken. You have your
hearings before the Secretary, your
facts are produced before the Secre-
tary ; and the law, of course, must con-
form to the facts. That is your case.
Any grower who feels himself ag-
grieved, of course, has the right to get
an injunction. It seems to me as I look
over this amendment offered by the
gentleman from Michigan that it is an
excellent amendment and much better
than section 701. Section 701 seems to
me to hamstring our law and make it
pretty easy for the makers of proprie-
tary and patent medicines to defeat
the wishes of Congress by constantly
going into various hearings and taking
appeals from the hearings and going
into court for injunctions. With 85 dif-
ferent district courts, just think of the
chance a chain store has. It could un-
doubtedly prolong litigation and hold
it up in one State after another. The
way to avoid that, in my judgment, is
to hold the hearing before the Secre-
tary, and let the Secretary make his
findings. If, then, the applicant feels
himself aggrieved, let him take an ap-
peal to the circuit court of appeals
rather than to the district court, be-
cause there are a limited number of
circuit courts of appeal; and, secondly,
when a decision is handed down you
are more apt to have uniformity of
decisions. This stands to reason. In
looking over the amendment offered by
-------
STATUTES AND LEGISLATIVE HISTORY
1037
the gentleman from Michigan it seems
to me ample remedy is afforded to any
applicant who feels himself aggrieved,
because one part of the amendment
gives him the opportunity to bring any
additional evidence he may have on
which to make a showing.
[Here the gavel fell.]
Mr. LEAVY. Mr. Chairman, I rise
in opposition to the pro forma amend-
ment, [p. 7895]
Mr. Chairman, it is to be regretted
that so many of us who apparently
think alike are so far apart upon this
particular amendment. The difficulty
doubtless lies in the fact that the Pure
Food and Drug Administration is
being given power to regulate by a
bureaucratic order both processed
products and those that are produced
naturally. The argument made in op-
position to the present language in the
law has some substantial weight when
applied to processed products, but
when you get over into the field of
natural products, like all fruits and
vegetables growing above ground, that
have to be protected from pests by the
use of spray material, then you have
examples in which it does an injury
that is irreparable. The individual pro-
ducer can get no relief if he is denied
a hearing before the order is made, and
also denied a day in court as would
happen if this amendment prevails.
I take issue with the gentlemen who
say you can go into any Federal court
and there get an injunction against an
agent of the United States Govern-
ment, for official actions. Every lawyer
knows that the United States Govern-
ment cannot be made a party defen-
dant. No individual can bring a suit
against the Government except by con-
gressional authorization. I challenge
the gentleman from Michigan [Mr.
MAPES] to cite authority authorizing
such general actions, as he refers to in
his remarks, where the citizen can in-
stitute suit against the United States.
Mr. SAUTHOFF. Mr. Chairman,
will the gentleman yield?
Mr. LEAVY. I will yield to the
gentleman if he will cite me the Fed-
eral statute that authorizes an action
of that kind on the part of an individ-
ual against the United States Govern-
ment.
Mr. SAUTHOFF. I am not citing—
Mr. LEAVY. If the gentleman can-
not give me a citation, I do not care to
have more of my time consumed.
Mr. SAUTHOFF. The suit is
brought against the person holding of-
fice, not against the Government.
Mr. LEAVY. The person making the
order is an executive officer of the
Government.
Mr. SAUTHOFF. Certainly.
Mr. LEAVY. He is appointed by the
Secretary of Agriculture. The Secre-
tary of Agriculture is appointed by the
President, who is the head of the exec-
utive branch of the Government; and
any court action must be against him
as an official, and not as an individual;
therefore it becomes a suit against
the United States.
The reason this has no comparison
with the citations of law concerning
the Federal Trade Commission and the
Communications Commission and all
those other commissions is the fact
that they are not executive arms of the
Government; they are quasi-judicial
bodies that hold hearings and deter-
mine in a judicial manner the facts.
In the instant case, however, you have
an executive officer who arbitrarily sits
down, without hearing a particle of
evidence, if he sees fit, and makes an
order. That is exactly what occurred, so
far as I have been able to learn, in con-
nection with spray residue. I am sure
no one will contend there was a hear-
ing where evidence was taken, where
interested parties could appear, and
where a record was made.
*****
Mr. ROBERTSON. Does not the
gentleman from Washington think that
a man who has all of his life savings
invested in an apple orchard should
-------
1038
LEGAL COMPILATION—PESTICIDES
have a day in court before we put him
out of business through some depart-
mental order?
Mr. LEAVY. I certainly do, and that
is exactly what this bill gives to him.
It is a question whether you are going
to permit the American citizen, whose
economic existence is being threatened
and taken from him, the opportunity
to go into court.
[p.7895]
Mr. REES of Kansas. The assump-
tion is that the Department of Agri-
culture is going to pick up the apple
growers and be particularly unfair to
that particular group.
Mr. ROBERTSON. No; I do not say
that; but I say before you pass a law
that would enable the Department to
wipe out an industry you should give
that industry an opportunity to have
a day in court on the reasonableness of
the regulations that are promulgated.
[p. 7896]
Mr. WHITE of Idaho. Is it not a
fact that the apple producers and ap-
ple shippers comply with the rules and
regulations of the Department of Ag-
riculture and wash apples and prepare
them for shipment in compliance with
the regulations for the removal of the
spray?
Mr. O'CONNELL of Montana. The
very reason you are pleading here or
the very reason that the apple growers
are pleading here is because they do
not want to comply with the regula-
tions of the Department. They want to
have this so-called spurious court pro-
ceeding or court review, which would
permit them to go into courts all over
the country and permit them to tie up
the proceedings indefinitely, and then
after a decision is rendered they will
take up some other protective feature
of the law and go into the courts on
that, so that, finally, you will have no
food and drug law whatsoever.
[Here the gavel fell.]
Mr. BUCK.
*****
The only safety the average citizen,
not merely the apple and pear grower,
has is to require the Government to
prove in every case the soundness of
its regulations and the basis on which
they rest. There is no way in the world,
unless you leave this section in the bill,
whereby not merely the apple grower,
but the pear grower, or any other pro-
ducer of perishable commodities can
protect himself against such erratic
meanderings of the minds of the de-
partmental authorities as I have briefly
cited you.
Mr. LEA. Mr. Chairman, it is un-
fortunate that a question of law and of
legitimate procedure for the protection
of the the people of the United States
must be discussed with so much exag-
geration and distortion as has been
presented here today.
Some time ago I attended a meeting
of about 300 lawyers in the city of
Washington who were concerned with
administrative law. It seemed to be the
unanimous opinion of these men, even
the men in the Government Depart-
ments themselves, that we badly need
a provision regulating the court review
of administrative proceedings. I be-
lieve there is no good lawyer in the
United States who will not admit we
are seriously in need of legislative im-
provement of procedure as to adminis-
trative law and practice. Our com-
mittee recognizes this, and we have
attempted in this bill to provide a
legitimate, orderly method of hearing
these cases and disposing of them more
promptly and in a way that will greatly
reduce litigation. If more farsighted
and progressive, the Departments
would welcome provisions such as we
have in this bill. With greater prestige
to themselves they would face less
litigation and dispose of their cases
more promptly. But to the static mind
every innovation, no matter how bene-
ficial ultimately, is destructive of their
rights. They cannot conceive of their
being deprived of any arbitrary power
to the advantage of the public.
A substitute amendment is proposed
-------
STATUTES AND LEGISLATIVE HISTORY
1039
here that seeks to gut this court-review
section. It does all it can to destroy a
legitimate court review without pro-
viding one that is of any use. It pro-
vides, among other things, that if the
record contains any evidence to support
the findings, then the court must deny
relief against arbitrary action by the
administrative agency. The proposal
is absurd on the face of it. Nothing
could be better written into the law to
shield irresponsible government, than
the court review in the gentleman's
amendment. It is a perfect arrange-
ment for arbitrary exercise of power
without legitimate opportunity for the
citizen affected to protect himself.
Mr. LEA. But the Federal Trade
Commission is a semi-judicial body.
Here we have a purely administrative
body with no judicial procedure. Even
if I supported a less desirable provision
yesterday that is no reason I should
repeat the mistake today.
I know of a case in one of the Depart-
ments in which three men had the right
to write regulations. They were inex-
perienced men; they were incompetent
men. They would go into a back room
and write regulations, with the result
that there was a regular stream of
irresponsible regulations coming from
that Department. After a little experi-
ence was applied to their regulations
they appeared as utterly ridiculous.
It is a question whether you want
orderly government by legitimate pro-
cedure, or whether you want to protect
irresponsible, bureaucratic control. Do
you want government by edict, or by
orderly procedure. We have had to
fight for any court review. Now it is
claimed the Department is for some
kind of a court review. What we are
offered is a pretense instead of sub-
stance. It is a shield for the exercise of
arbitrary power. The amendment pre-
sented here is skillfully designed to
really prevent any legitimate and
necessary court review.
It is said that there is no comparable
law. As to fundamental features,
that would not be true; but it is true
that today we have no legitimate
orderly law that provides for a practi-
cal method of testing the validity of
regulations prior to their enforcement.
Recently the Supreme Court re-
versed a case affecting the Secretary
of Agriculture, and why? The case had
been pending for 7 years, and only the
other day it was decided on a matter of
procedure instead of passing on the
merits. It was because we do not have
any orderly procedure provided by the
statutes of the United States such as
we offer here. If this provision had
been in effect, the Secretary of Agri-
culture would probably have had that
case decided several years ago, and in
his favor. He would have been provided
with a clearly defined course of duty
that would have saved him from the
pitfall in which he finds himself. Our
court-review procedure is largely based
on judicial interpretation of the Con-
stitution, without any orderly defined
procedure.
*****
One great trouble we have had in the
formulation of this bill is propaganda.
We have had innocent groups of good
people used to pull chestnuts for
shrewd propagandists in Washington.
A wire goes out from Washington, and
next day these good people, with little
knowledge of what it is all about,
proceed to act as if they were manikins
operated by the irresponsible and con-
cealed hand corrupting their sources of
information from Washington. They
permit themselves to be used to seek to
intimidate or influence men in Congress
to act in violation of their own better
judgment.
This problem involves regulations
adopted by administrative departments
with the people of the United States
not knowing who is writing the regu-
lations, regulations that have the effect
of a law passed by this Congress,
Nation-wide in scope, for violating
which a citizen may be sent to jail for
as much as 3 years. Do you want such
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1040
LEGAL COMPILATION—PESTICIDES
important functions performed in a
perfunctory and irresponsible way, or
subject to a procedure that will assure
that work being done under a sense of
responsibility?
In 1933, after the spraying season
was partly over, news came out that
certain tolerances only would be per-
mitted. Then came the question of
inspection to see whether or not the
pears, or apples, or whatever the food
might be, conformed. It was proposed
that the farmers' fruit would be in-
spected at New York. He took it to the
packing house in California, shipped
it to New York on consignment because
he could not sell it for cash, and subject
to inspection at New York. If it did not
conform to the requirements it had
either to be reconditioned or destroyed.
When you destroy a carload of fruit it
means that the average small farmer
in California has lost all the profits
on his fruit that year. He may have
figured on paying off part of his mort-
gage or doing something for his family,
but a regulation like that if carried
out would have prevented it. I sincerely
hope the substitute amendment will be
defeated.
[Here the gavel fell.]
The CHAIRMAN. The question is
on the amendment offered by the gen-
tleman from Michigan.
The question was taken; and on a
division (demanded by Mr. MAPES)
there were—ayes 34, noes 57.
So the amendment was rejected.
[p. 7898]
Mr. LEA. Mr. Chairman, I offer an
amendment to the preceding section.
The Clerk read as follows:
Amendment offered by Mr. LEA: Page 82,
lines 17 to 19, strike out the words "at the re-
quest of any interested industry or substan-
tial portion thereof" and in lieu thereof insert,
"or upon an application of any interested in-
dustry or substantial portion thereof stating
reasonable grounds therefor."
Mr. LEA. Mr. Chairman, this is the
amendment that during general debate
I stated I would offer. It provides that
when a request is made on the Secre-
tary of Agriculture for a hearing
before him reasonable grounds shall
be shown; and it is a further attempt
to meet the attitude of the Department
of Agriculture as to procedure under
the court review section.
Mr. MAPES. Mr. Chairman, I rise
in support of this amendment because
it corrects in some respects the action
of the committee to which the minority
report called attention, and which the
minority report said weakened the ad-
ministrative feature of the act. I am
glad to note that the majority of the
committee has been converted to the
views of the minority in this respect.
The CHAIRMAN. The question is on
the amendment offered by the gentle-
man from California [Mr. LEA].
The amendment was agreed to.
Mr. LEA. Mr. Chairman, I offer
another amendir ent which I send to
the Clerk's desk.
The Clerk reaJ: ,s follows:
Amendment offered y Mr. LEA; Page 85, line
5, after the word "i equest", insert "and pay-
ment of the costs thereof."
The amendment was agreed to.
[p. 7899]
1.12a (5) (c) VOL. 83 (1938), June 10: Senate agrees to confer-
ence report, pp. 8731-8738
[No Relevant Discussion on Pertinent Section]
1.12a (5) (d) VOL. 83 (1938), June 13: House agrees to confer-
ence report, pp. 9095-9100
[No Relevant Discussion on Pertinent Section]
1.12b 1940 REORGANIZATION PLAN IV, SECTION 12,
54 STAT. 1237
SEC. 12. Transfer of Food and Drug Administration.—The Food
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STATUTES AND LEGISLATIVE HISTORY 1041
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]
1.12c JUDICIAL CODE, DEFINITION, AMENDMENTS
June 25,1948, P.L. 80-773, §32, 62 Stat. 991
SEC. 32. As used in any statute of the United States:
"Circuit court of appeals" means a "United States court of
appeals";
"Senior circuit judge" means "chief judge of a judicial circuit";
"Senior district judge" means "chief judge of a United States
district court";
"Chief Justice" means "chief judge" except when reference to
the Chief Justice of the United States is intended;
"Justice" means "judge" except when used with respect to a
justice of the Supreme Court of the United States in his capacity
as such or as circuit justice;
"Presiding judge" means "chief judge."
[p.991]
1.12c (1) HOUSE COMMITTEE ON THE JUDICIARY
H.R. REP. No. 308, 80th Cong., 1st Sess. (1947)
REVISION OF TITLE 28, UNITED STATES CODE
APRIL 25,1947.—Ordered to be printed
Mr. ROBSION, from the Committee on the Judiciary, submitted
the following
REPORT
[To accompany H.R. 3214]
The committee on the Judiciary submits the following report in
explanation of the bill (H.R. 3214) to revise, codify, and enact
into law title 28 of the United States Code entitled "Judicial Code
and Judiciary," and recommends that the bill do pass. The pres-
ent bill has been substituted for an earlier bill (H.R. 2055) on
which hearings were held and contains changes recommended by
the subcommittee. To 11
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1042 LEGAL COMPILATION—PESTICIDES
1.12c (2) SENATE COMMITTEE ON THE JUDICIARY
S. REP. No. 1559, 80th Cong., 2d Sess. (1948)
REVISING, CODIFYING, AND ENACTING INTO LAW
TITLE 28 OF THE UNITED STATES CODE, ENTITLED
"JUDICIAL CODE AND JUDICIARY"
JUNE 9 (legislative day, JUNE 1), 1948.—Ordered to be printed
Mr. WILEY, from the Committee on the Judiciary, submitted the
following
REPORT
[To accompany H.R. 3214]
The Committee on the Judiciary, to whom was referred the
bill (H.R. 3214) to revise, codify, and enact into law title 28 of
the United States Code, entitled "Judicial Code and Judiciary,"
having considered the same, do now report the bill to the Senate
favorably, with amendments, and recommend that the bill, as
amended, do pass.
The purpose of the bill is to codify and revise the laws relating
to the Federal judiciary and judicial procedure.
No revision of these laws has been made since 1911, and the
Judicial Code enacted in that year did not include all the laws
upon the subject.
A tremendous amount of additional legislation in this field has
been enacted since 1911. Consequently, there is now a great mass
of statutory material upon this subject, much of which is ar^v ac,
ambiguous, conflicting, and to an unascertained extent repealed
by implication by later statutes. These statutes are scattered
through many volumes of the Statutes at Large which are not
easily accessible to the bench and bar. Moreover, many of the
statutes relating to procedure appearing in the books have been
rendered wholly obsolete by the Federal Rules of Civil Procedure
prescribed by the Supreme Court. This situation results in the
loss of much time and effort on the part of the bench and bar in
determining what is the present law in this field, always at the
risk of possible error.
It is evident, therefore, that a thorough codification and revi-
sion of the statutes relating to the judiciary and its procedure is
very much in the public interest in order that the law in this
important field may be clear, certain, and readily available.
The bill H.R. 3214 accomplishes these desirable results. r ^ -,
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