KF3775 United States Office of
Environmental Protection Pesticide Programs
•A33 Agency Washington DC 20460
1978
November 1978 OPA 17/9
The Federal
Insecticide, Fungicide,
and Rodenticide Act
as Amended
Public Law 92-516
October 21, 1972
as amended by
Public Law 9^140
November 28, 1975
and Public Law 95-396
September 30, 1978
U.S. Environmental Protection Agency
Region 5, library (PL- 12J)
77 West Jackson Boulevard, 12tti Ftacr
Chicago, ft 60604-3590
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Public Law 92-5 16, 92nd Congress, H.R. 10729, October 21, 1972 as amended
by Public Law 94-140, 94th Congress, H.R. 8841, November 28, 1975 and
Public Law 95-396, 95th Congress, S. 1678, September 30, 1978.
86 STAT. 973-999
To amend the Federal Insecticide, Fungicide, and Rodenticide Act, and for
other purposes.
Federal Be it enacted by the Senate and House Representatives of the United States
pKt'c°demenla' of America in Congress assembled, That this Act may be cited as the "Federal
conmAct Environmental Pesticide Control Act of 1972."
of 1972
Amendments to Federal Insecticide, Fungicide, and Rodenticide Ac!
6i stat 163, Sec. 2. The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136
78 siat 190 et Seq.) is amended to read as follows:
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"SECTION 1. SHORT TITLK AND TABLE OK CONTENTS.
(a) Short Title — This Act may be cited as the 'Federal Insecticide,
Fungicide, and Rodenticide Act'.
(b) Table of Contents —
'Section 1. Short title and table of contents
"(a) Short title
"(b) Table of contents.
"Sec 2 Definition!,.
"(a) Active ingredient.
"(b) Administrator
"(c) Adulterated
"(d) Animal.
"(e) Certified applicator, etc.
"(1) Certified applicator.
"(2) Private applicator
"(3) Commercial applicator.
"(4) Under the direct supervision
of a certified applicator.
"(f) Defoliant.
"(g) Desiccant
"(h) Device.
"(i) District court "Sec
"(j| Environment appli
"(k) Fungus
"(1) Imminent hazard.
"(m) Inert ingredient.
"(n) Ingredient statement.
"(o) Insect.
"(p) Label and labeling
"(1) Label
"(2) Labeling.
"(q) Misbranded.
"(r) Nematodc.
"(s) Person
"(t) Pest
"(u) Pesticide.
"(v) Plant regulator.
"(w) Producer and produce
"(x) Protect health and (he environ- "Sec
ment
"(y) Registrant.
"(z) Registration.
"(aa) State.
"(bb) Unreasonable adverse effects on
the environment
"(cc) Weed
"(dd) Establishment.
"(ee) To use any registered pesticide in a
manner inconsistent with its labeling.
'Sec. 3. Registration of pesticides.
"(a) Requirement
"(b) Exemptions.
"(c) Procedure for registration
"(1) Statement required "Sec
"(2) Data in support of registra-
tion.
"(3) Time for acting with respect
to application.
"(4) Notice of application.
"(5) Approval 'of registration "Sec
"(6) Denial of registration.
"(7) Registration under special cir-
cumstances "Sec
"(8) Interim administrative review
"(d) Classification of pesticides.
"(1) Classification for general use,
restricted use, or both.
"(2) Change in classification.
"(3) Change in classification from
restricted use to general use.
"(e) Products with same formulation
and claims.
"(f) Miscellaneous.
"(1) Effect of change of labeling
or formulation.
"(2) Registration not a defense.
"(3) Authority to consult othei
Federal agencies
"(g) Reregistration of pesticides.
. 4. Use of restricted use pesticides; certified
cators.
"(a) Certification procedure.
"(1) Federal certification
"(2) State certification.
"(b) State plans.
"(c) Instruction in integrated pest
management techniques.
. 5 Experimental use permits.
"(a) Issuance.
"(b) Temporary tolerance level.
"(c) Use under permit
"(d) Studies.
"(e) Revocation
"(f) State issuance of permits.
"(g) Exemption for agricultural research
agencies
6. Administrative review; suspension.
"(a) Cancellation alter five years.
"(1) Procedure
"(2) Information.
"(b) Cancellation and change m classifi-
cation
"(c) Suspension.
"(1) Order.
"(2) Expedite hearing.
"(3) Emergency order
"(4) Judicial review.
"(d) Public hearings and scientific re-
view
"(e) Conditional registration.
"(f) Judicial review
. 7 Registration of establishments.
"(a) Requirements
"(b) Registration.
"(c) Information required
"(d) Confidential records and informa-
tion.
. 8 Books and records.
"(a) Requirement.
"(b) Inspection.
9. Inspection of establishments, etc
"(a) In general
"(b) Warrants.
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"(c) Enforcement.
"(1) Certification of facts to At-
torney General.
"(2) Notice not required.
"(3) Warning notices.
"Sec. 10. Protection of trade secrets and other
information.
"(a) In general.
"(b) Disclosure
"(c) Disputes.
"(d) Limitations.
"(e) Disclosure to contractors.
"(f) Penalty for disclosure by Federal
employees.
"(g) Disclosure to foreign and multi-
national pesticide producers.
"Sec. 11. Standards applicable to pesticide ap-
plicators.
"(a) In general.
"(b) Separate standards.
"Sec. 12. Unlawful acts.
"(a) In general.
"(b) Exemptions.
"Sec. 13. Stop sale, use, removal, and seizure.
"(a) Stop sale, etc., orders.
"(b) Seizure.
"(c) Disposition after condemnation.
"(d) Court costs, etc.
"Sec. 14. Penalties
"(a) Civil penalties.
"(1) In general.
"(2) Private applicator.
"(3) Hearing
"(4) Determination of penalty.
"(5) References to Attorney
General.
"(b) Criminal penalties.
"(1) In general.
"(2) Private applicator.
"(3) Disclosure of information.
"(4) Acts of officers, agents, etc.
15. Indemnities.
"(a) Requirement.
"(b) Amount of payment
"(1) In general.
"(2) Special rule.
16. Administrative procedure, judicial
;'Sec
"Sec,
review.
"(a) District court review.
"(b) Review by Court of Appeals.
"(c) Jurisdiction of district courts.
"(d) Notice of judgments.
"Sec. 17. Imports and exports
"(a) Pesticides and devices intended for
export.
"(b) Cancellation notices furnished to
foreign governments
"(c) Importation of pesticides and de-
vices.
"(d) Cooperation in international
efforts.
"(e) Regulations.
"Sec. 18. Exemption of Federal agencies.
"Sec. 19. Disposal and transportation.
"(a) Procedures.
"(b) Advice to Secretary of Transporta-
tion.
"(c) Provisions for unused quantities.
"Sec. 20. Research and monitoring.
"(a) Research.
"(b) National monitoring plan.
"(c) Monitoring.
"Sec. 21. Solicitation of comments; notice of
public hearings.
"Sec. 22. Delegation and cooperation.
"(a) Delegation.
"(b) Cooperation.
"Sec. 23. State cooperation, aid, and training.
"(a) Cooperative agreements.
"(b) Contracts for training
"(c) Information and education.
"Sec. 24. Authority of States.
"Sec. 25. Authority of Administrator.
"(a) (1) Regulations.
"(2) Procedure.
"(3) Congressional committees.
"(b) Exemption of pesticides.
"(c) Other authority.
"(a) Scientific advisory panel.
"Sec. 26 State primary enforcement responsi-
bility.
"Sec. 27. Failure by the State to assure enforce-
ment of State pesticide use regulations.
"Sec. 28. Identification of pests; cooperation
with Department of Agriculture's program.
"Sec. 29 Annual report.
"Sec. 30. Severability.
"Sec. 31. Authorization for appropriations "
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"SEC. 2. DEFINITIONS.
"For purposes of this Act—
"(a) Active Ingredient.—The term 'active ingredient' means—
"(1) in the case of a pesticide other than a plant regulator, defoliant,
or desiccant, an ingredient which will prevent, destroy, repel, or
mitigate any pest;
"(2) in the case of a plant regulator, an ingredient which, through
physiological action, will accelerate or retard the rate of growth or rate
of maturation or otherwise alter the behavior of ornamental or crop
plants or the product thereof;
"(3) in the case of a defoliant, an ingredient which will cause the
leaves or foliage to drop from a plant; and
"(4) in the case of a desiccant, an ingredient which will artificially ac-
celerate the drying of plant tissue.
"(b) Administrator.—The term 'Administrator' means the Administrator
of the Environmental Protection Agency.
"(c) Adulterated.—The term 'adulterated' applies to any pesticide if:
"(1) its strength or purity falls below the professed standard of quali-
ty as expressed on its labeling under which it is sold;
"(2) any substance has been substituted wholly or in part for the
pesticide; or
"(3) any valuable constituent of the pesticide has been wholly or in
part abstracted.
"(d) Animal.—The term 'animal' means all vertebrate and invertebrate
species, including but not limited to man and other mammals, birds, fish, and
the shellfish.
"(e) Certified Applicator, Etc.—
"(1) Certified applicator.—The term 'certified applicator' means any
individual who is certified under section 4 as authorized to use or super-
vise the use of any pesticide which is classified for restricted use. Any p i 95-1%.
applicator who holds or applies registered pesticides, or use dilutions of 92 Sul s"
registered pesticides consistent with section 2(ee) of this Act, only to
provide a service of controlling pests without delivering any unapplied
pesticide to any person so served is not deemed to be a seller or
distributor of pesticides under this Act.
"(2) Private applicator.—The term 'private applicator' means a cer-
tified applicator who uses or supervises the use of any pesticide which is
classified for restricted use for purposes of producing any agricultural
commodity on property owned or rented by him or his employer or (if
applied without compensation other than trading of personal services
between producers of agricultural commodities) on the property of
another person.
"(3) Commercial applicator.—The term 'commercial applicator'
means an applicator (whether or not he is private applicator with respect
to some uses) who uses or supervises the use of any pesticide which is
classified for restricted use for any purpose or on any property other
than as provided by paragraph (2).
"(4) Under the direct supervision of a certified applicator.— Unless
otherwise prescribed by its labeling, a pesticide shall be considered to be
applied under the direct supervision of a certified applicator if it is ap-
plied by a competent person acting under the instructions and control of
a certified applicator who is available if and when needed, even though
such certified applicator is not physically present at the time and place
the pesticide is applied.
"(0 Defoliant.—The term 'defoliant' means any substance or mixture of
substances intended for causing the leaves or foliage to drop from a plant,
with or without causing abscission.
"(g) Desiccant.—The term 'desiccant' means any substance or mixture of
substances intended for artificially accelerating the drying of plant tissue.
"(h) Device.—The term 'device' means any instrument or contrivance
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(other than a firearm) which is intended for trapping, destroying, repelling, or
mitigating any pest or any other form of plant or animal life (other than man
and other than bacteria, virus, or other microorganism on or in living man or
other living animals); but not including equipment used for the application of
pesticides when sold separately therefrom.
"(i) District Court.—The term 'district court' means a United States
district court, the District Court of Guam, the District Court of the Virgin
Islands, and the highest court of American Samoa
"(j) Environment.—The term 'environment' includes water, air, land, and
all plants and man and other animals living therein, and the interrelationships
which exist among these.
"(k) f-ungut,.— The term 'tungus' means any non-chlorophyll-bearing
thallophyte (that is, any non-chlorophyll-bearing plant of a lower ordei than
mosses and liverworts), as for example, rust, smut, mildew, mold, yeasi, and
bacteria, except those on or in living man or other animals and those on or in
processed food, beverages, or Pharmaceuticals.
"1) Imminent Hazard.—The term 'imminent hazard' means a situation
which exists when the continued use of a pesticide during the time required for
cancellation proceeding would be likely to result in unreasonable adverse ef-
fects on the environment or will involve unreasonable hazard to the survival of
a species declared endangered by the Secretary of the Interior under Public
Law 91-135.
"(m) inert Ingredient.—The term "inert ingredient' means an ingredient
which is not active.
"(n) Ingredient Statement —The term 'ingredient statement' means a state-
ment which eontams—
"(1) the name and percentage of each active ingredient, and the total
percentage of all inert ingredients, in the pesticide; and
"(2) if the pesticide contains arsenic in any form, a statement of the
percentages of total and water soluble arsenic, calculated as elementary
arsenic.
"(o) Insect.—The term 'insect' means any of the numerous small in-
vertebrate animals generally having the body more or less obviously
segmented, for the most part belonging to the class insecta, comprising six-
legged, usually winged forms, as for example, beetles, bugs, bees, flies, and to
other allied classes of arthropods whose members are wingless and usually
have more than six legs, as for example, spiders, mites, ticks, centipedes, and
wood lice.
"(p) Label and Labeling.—
"(1) Label.—The term 'label' means the written, printed, or graphic
matter on, or attached to, the pesticide or device or any of its containers
or wrappers.
"(2) Labeling.—The term "labeling' means all labels and all other
written, printed, or graphic matter—
"(A) accompanying the pesticide or device at any time; or
"(B) to which reference is made on the label or in literature ac-
companying the pesticide or device, except to current official
publications of the Environmental Protection Agency, the United
States Departments of Agriculture and Interior, the Department of
Health, Education, and Welfare, State experiment stations, State
agricultural colleges, and other similiar Federal or State instituiions
or agencies authorized by law to conduct research in the field of
pesticides.
"(q) Misbranded.—
"(1) A pesticide is misbranded if—
"(A) its labeling bears any statement, design, or graphic represen-
tation relative thereto or to its ingredients which is false or
misleading in any particular;
"(B) it is contained in a package or other container or wrapping
which does not conform to the standards established by the Ad-
ministrator pursuant to section 25(c)(3);
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"(C) it is an imitation of, or is offered for sale under the name of,
another pesticide;
"(D) its label does not bear the registration number assigned 7 use 131*
under section 7 to each establishment in which it was produced;
"(E) any word, statement, or other information required by or
under authority of this Act to appear on the label or labeling is not
prominently placed thereon with such conspicuousness (as compared
with other words, statements, designs, or graphic matter in the label-
ing) and in such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use;
"(F) the labeling accompanying it does not contain directions for
use which are necessary for effecting the purpose for which the
product is intended and if complied with, together with any re-
quirements imposed under section 3(d) of this Act, are adequate to i use nsa
protect health and the environment;
"(G) the label does not contain a warning or caution statement
which may be necessary and if compiled with, together with any re-
quirements imposed under section 3(d) of this Act, is adequate to 7 LSC n6a
protect health and the environment; or
"(H) in the case of a pesticide not registered in accordance with PI 95396, 92 sui si9,
section 3 of this Act and intended for export, the label does not con- i LSC n6a
tain, in words prominently placed thereon with such conspicuousness
(as compared with other words, statements, designs, or graphic mat-
ter in the labeling) as to render it likely to be noted by the ordinary
individual under customary conditions of purchase and use, the
following: 'Not Registered for Use in the United States of America'.
"(2) A pesticide is misbranded if—
"(A) the label does not bear an ingredient statement on that part
of the immediate container (and on the outside container or wrapper
of the retail package, if there be one, through which the ingredient
statement on the immediate container cannot be clearly read) which
is presented or displayed under customary conditions of purchase,
except that a pesticide is not misbranded under this subparagraph if:
"(i) the size of form of the immediate container, or the outside
container or wrapper of the retail package, makes it impracticable
to place the ingredient statement on the part which is presented or
displayed under customary conditions of purchase: and
"(ii) the ingredient statement appears prominently on another
part of the immediate container, or outside container or wrapper,
permitted by the Administrator;
"(B) the labeling does not contain a statement of the use
classification under which the product is registered;
"(C) there is not affixed to its container, and to the outside con-
tainer or wrapper of the retail package, if there be one, through
which the required information on the immediate container cannot
be clearly read, a label bearing—
"(i) the name and address of the producer, registrant, or per-
son for whom produced;
"(ii) the name, brand, or trademark under which the pesticide
is sold;
"(iii) the net weight or measure of the content; Provided, That
the Administrator may permit reasonable variations; and
"(iv) when required by regulation of the Administrator to ef-
fectuate the purposes of this Act, the registration number as-
signed to the pesticide under this Act, and the use classification;
and
"(D) the pesticide contains any substance or substances in quan-
tities highly toxic to man, unless the label shall bear, in addition to
any other matter required by this Act—
"(i) the skull and crossbones;
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"(ii) the word 'poison' prominently in red on a background of
distinctly contrasting color; and
"(iii) a statement of a practical treatment (first aid or otheiwise)
in case of poisoning by the pesticide.
"(r) Nematode.—The term 'nematode' means invertebrate animals of the
phylum nemathelminthes and class nematoda, that is, unsegmented round
worms with elongated, fusiform, or saclike bodies covered with cuticle, and
inhabiting soil, water, plants, or plant parts; may also be called nemas or
eelworms.
"(s) Person.—The term 'person' means any individual, partneiship,
association, corporation, or any organized group of persons whether incor-
porated or not.
"(t) Pest.—The term 'pest' means (1) any insect, rodent, nematode,
fungus, weed, or (2) any other form of terrestrial or aquatic plant or animal
life or virus, bacteria, or other micro-organism (except viruses, bacteria, or
other micro-organisms on or in living man or other living animals) which the
T use B6w Administrator declares to be a pest under section 25(c)(l).
PL 94-i4o, "(u) Pesticide.—The term'pesticide'means (1) any substance or mixture of
89SlaI 754 substances intended for preventing, destroying, repelling, or mitigating any
pest, and (2) any substance or mixture of substances intended for use as a plant
regulator, defoliant, or desiccant: Provided, That the term 'pesticide' shall not
include any article (l)(a) that is a 'new animal drug' within the meaning of sec-
tion 201(w) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(w)),
or (b) that has been determined by the Secretary of Health, Education, and
Welfare not to be a new animal drug by a regulation establishing conditions of
use for the article, or (2) that is an animal feed within the meaning of section
201(x) of such Act (21 U.S.C.321(x)) bearing of containing an article covered
by clause (1) of this proviso."
"(v) Plant Regulator.—The term 'plant regulator' means any substance or
mixture of substances intended, through physiological action, for accelerating
or retarding the rate of growth or rate of maturation, or for otherwise altering
the behavior of plants or the produce thereof, but shall not include substances
to the extent that they are intended as plant nutrients, trace elements, nutri-
tional chemicals, plant inoculants, and soil amendments. Also, the term 'plant
regulator' shall not be required to include any of such of those nutrient mix-
tures or soil amendments as are commonly known as vitamin-hormone hor-
ticultural products, intended for improvement, maintenance, survival, health,
and propagation of plants, and as are not for pest destruction and are non-
toxic, nonpoisonous in the undiluted packaged concentration.
"(w) Producer and Produce.—The term 'producer' means the person who
manufactures, prepares, compounds, propagates, or processes any pesticide or
p i 95-396. device or active ingredient used in producing a pesticide. The term 'produce'
92Stai 819 means to manufacture, prepare, compound, propagate, or process any
pesticide or device, or active ingredient used in producing a pesticide. The
dilution by individuals of formulated pesticides for their own use and accor-
ding to the directions on registered labels shall not of itself result in such in-
dividuals being included in the definition of 'producer' for the purposes of this
Act."
"(x) Protect Health and the Environment.—The terms 'protect health and
the environment' and 'protection of health and the environment' mean protec-
tion against any unreasonable adverse effects on the environment.
"(y) Registrant.—The term 'registrant' means a person who has registered
any pesticide pursuant to the provisions of this Act.
"(z) Registration.—The term 'registration' includes reregistration.
"(aa) State.— The term 'State' means a State, the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Trust Territory
of the Pacific Islands, and American Samoa.
"(bb) Unreasonable Adverse Effects on the Environment.—The term
'unreasonable adverse effects on the environment' means any unreasonable
risk to man or the environment, taking into account the economic, social, and
environmental costs and benefits of the use of any pesticide.
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"(cc) Weed.—The term 'weed' means any plant which grows where not
wanted.
"(dd) Establishment.—The term 'establishment' means any place where a
pesticide or device or active ingredient used in producing a pesticide is
produced, or held, for distribution or sale.
"(ee) To Use Any Registered Pesticide in a Manner Inconsistent With Its
Labeling.—The term 'to use any registered pestiscide in a manner inconsistent
with its labeling" means to use any registered pesticide in a manner not permit-
ted by the labeling: Provided, That the term shall not include (1) applying a
pesticide at any dosage, concentration, or frequency less than that specified on
the labeling, (2) applying a pesticide against any target pest not specified on
the labeling if the application is to the crop, animal, or site specified on the
labeling, unless the Administrator has required that the labeling specifically
state that the pesticide may be used only for the pests specified on the labeling
after the Administrator has determined that the use of the pesticide against
other pests would cause an unreasonable adverse effect on the environment,
(3) employing any method of application not prohibited by the labeling, or (4)
mixing a pesticide or pesticides with a fertilizer when such mixture is not pro-
hibited by the labeling: Provided further, That the term also shall not include
any use of a pesticide inconformance with section 5, 18, or 24 of this Act, or any
use of a pesticide in a manner that the Administrator determines to be consis-
tent with the purposes of this Act: And provided further, That after March 31,
1979, the term shall not include the use of a pesticide for agricultural or
forestry purposes at a dilution less than label dosage unless before or after that
date the Administrator issues a regulation or advisory opinion consistent with
the study provided for in section 27(b) of the Federal Pesticide Act of 1978,
which regulation or advisory opinion specifically requires the use of definite
amounts of dilution.
P L 95-396,
92 Slac 819
7 USC I36c, I36p, 136v
7 USC 136\v-4 nole
"SEC. 3. REGISTRATION OF PESTICIDES.
"(a) Requirement.—Except as otherwise provided by this Act, no person in
any State may distribute, sell, offer for sale, hold for sale, ship, deliver for
shipment, or receive and (having so received) delivery or offer to deliver, to
any person any pesticide which is not registered with the Administrator.
"(b) Exemptions.—A pesticide which is not registered with the Ad-
ministrator may be transferred if—
"(1) the transfer is from one registered establishment to another
registered establishment operated by the same producer solely for
packaging at the second establishment or for use as a constituent part of
another pesticide produced at the second establishment; or
"(2) the transfer is pursuant to and in accordance with the re-
quirements of an experimental use permit.
"(c) Procedure for Registration.—
(1) Statement required.—Each applicant for registration of a
pesticide shall file with the Administrator a statement which includes—
"(A) the name and address of the applicant and of any other per-
son whose name will appear on the labeling;
"(B) the name of the pesticide;
"(C) a complete copy of the labeling of the pesticide, a statement
of all claims to be made for it, and any directions for its use;
"(D) except as otherwise provided in subsection (c)(2)(D) of this
section, if requested by the Administrator, a full description of the
tests made and the results thereof upon which the claims are based,
or alternatively a citation to data that appears in the public literature
or that previously had been submitted to the Administrator and that
P L 95-396,
92 Stal 820
(See note below)
Note.
Section 2(b) of the Federal Pesticide Act of 1978 provides, The amendment to section 3(c)(l)(D) of 7 USC 136a note
the Federal Insecticide, Fungicide, and Rodenticide Act made by this section shall apply with respect
to all applications for registration approved after September 30, 1978.
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the Administrator may consider in accordance with the following
provisions:
"(i) with respect to pesticides containing active ingredients that
are initially registered under this Act after September 30, 1978,
data submitted to support the application for the original registra-
tion of the pesticide, or an application for an amendment adding
hxciuMve any new use to the registration and that pertains solely to such
"sc 0| dala new use, shall not, without the written permission of the original
data submitter, be considered by the Administrator to support an
application by another person during a period of ten years follow-
ing the date the Administrator first registers the pesticides: Pro-
vided, That such permission shall not be required in the case of
defensive data;
"(ii) except as otherwise provided in subparagraph (D)(i) of
this paragraph, with respect to data submitted after December 31,
1969, by an applicant or registrant to support an application for
registration, experimental use permit, or amendment adding a
new use to an existing registration, to support or maintain in ef-
fect an existing registration, or for reregistration, the Adminis-
trator may, without the permission of the original data submitter,
consider any such item of data in support of an application by any
other person (hereinafter in this subparagraph referred to as the
'applicant') within the fifteen-year period following the date the
data were originally submitted only if the applicant has made an
compensation offer to compensate the original data submitter and submitted
such offer to the Administrator accompanied by evidence of
delivery to the original data submitter of the offer. The terms and
amount of compensation may be fixed by agreement between the
original data submitter and the applicant, or, failing such agree-
ment, binding arbitration under this subparagraph. If, at the end
of ninety days after the date of delivery to the original data sub-
mitter of the offer to compensate, the original data submitter and
the applicant have neither agreed on the amount and terms of
compensation nor on a procedure for reaching an agreement on
the amount and terms of compensation, either person may initiate
Aeration binding arbitration proceedings by requesting the Federal Media-
tion and Conciliation Service to appoint an arbitrator from the
roster of arbitrators maintained by such Service. The procedure
and rules of the Service shall be applicable to the selection of such
arbitrator and to such arbitration proceedings, and the findings
and determination of the arbitrator shall be final and conclusive,
and no official or court of the United States shall have power or
jurisdiction to review any such findings and determination, except
for fraud, misrepresentation, or other misconduct by one of the
parties to the arbitration or the arbitrator where there is a verified
complaint with supporting affidavits attesting to specific in-
stances of such fraud, misrepresentation, or other misconduct.
The parties to the arbitration shall share equally in the payment of
the fee and expenses of the arbitrator. If the Administrator deter-
mines that an original data submitter has failed to participate in a
procedure for reaching an agreement or in an arbitration pro-
ceeding as required by this subparagraph, or failed to comply with
the terms of an agreement or arbitration decision concerning
compensation under this subparagraph, the original data submit-
ter shall forfeit the right to compensation for the use of the data
in support of the application. Notwithstanding any other provi-
sion of this Act, if the Administrator determines that an applicant
has failed to participate in a procedure for reaching an agreement
or in an arbitration proceeding as required by this subparagraph,
or failed to comply with the terms of an agreement or arbitration
decision concerning compensation under this subparagraph, the
8
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Administrator shall deny the application or cancel the registration
of the pesticide in support of which the data were used without
further hearing. Before the Administrator takes action under
either of the preceding two sentences, the Administrator shall fur-
nish to the affected person, by certified mail, notice of intent to
take actions and allow fifteen days from the date of delivery of
the notice for the affected person to respond. If a registration is
denied or canceled under this subparagraph, the Administrator
may make such order as the Administrator deems appropriate
concerning the continued sale and use of existing stocks of such
pesticide. Registration action by the Administrator shall not be
delayed pending the fixing of compensation;
"(iii) after expiration of any period of exclusive use and any
period for which compensation is required for the use of an item
of data under subparagraphs (D)(i) and (D)(ii) of this paragraph,
the Administrator may consider such item of data in support of
an application by any other applicant without the permission of
the original data submitter and without an offer having been
received to compensate the original data submitter for the use of
such item of data;
"(E) the complete formula of the pesticide; and
"(F) a request that the pesticide be classified for general use, for
restricted use, or for both.
"(2) (A) Data in support of registration.— The Administrator shall
publish guidelines specifying the kinds of information which will be
required to support the registration of a pesticide and shall revise
such guidelines from time to time. If thereafter he requires any addi-
tional kind of information under subparagraph (B) of this
paragraph, he shall permit sufficient time for applicants to obtain
such additional information. The Administrator, in establishing p L 95-396,
standards for data requirements for the registration of pesticides 92 Slal 824
with respect to minor uses, shall make such standards commensurate
with the anticipated extent of use, pattern of use, and the level and
degree of potential exposure of man and the environment to the
pesticide. In the development of these standards, the Administrator
shall consider the economic factors of potential national volume of
use, extent of distribution, and the impact of the cost of meeting the
requirements on the incentives for any potential registrant to under-
take the development of the required data. Except as provided by
section 10, within 30 days after the Administrator registers a 7 use i36h
pesticide under this Act he shall make available to the public the
data called for in the registration statement together with such other
scientific information as he deems relevant to his decision.
"(B) Additional data to support existing registrations.—
"(0 If the Administrator determines that additional data are PL 95396
required to maintain in effect an existing registration of a 92 Stal 822
pesticide, the Administrator shall notify all existing registrants of Nonficanon
the pesticide to which the determination relates and provide a list
of such registrants to any interested person.
"(ii) Each registrant of such pesticide shall provide evidence
within ninety days after receipt of notification that it is taking ap-
propriate steps to secure the additional data that are required .
Two or more registrants may agree to develop jointly, or to share iomi data
in the cost of developing, such data if they agree and advise the development
Administrator of their intent within ninety days after notification.
Any registrant who agrees to share in the cost of producing the
data shall be entitled to examine and rely upon such data in sup-
port of maintenance of such registration.
-------
Arbitration "(in) If, at the end of sixty days after advising the Ad-
ministrator of their agreement to develop jointly, or share in the
cost of developing, data, the registrants have not further agreed
on the terms of the data development arrangement or on a pro-
cedure for reaching such agreement, any of such registrants may
initiate binding arbitration proceedings by requesting the Federal
Mediation and Conciliation Service to appoint an arbitrator from
the roster of arbitrators maintained by such Service. The pro-
cedure and rules of the Service shall be applicable to the selection
of such arbitrator and to such arbitration proceedings, and the
findings and determination of the arbitrator shall be final and
conclusive, and no official or court of the United States shall have
power or jurisdiction to review any such findings and determina-
tion, except for fraud, misrepresentation, or other misconduct by
one of the parties to the arbitration or the arbitrator where there
is a verified complaint with supporting affidavits attesting to
specific instances of such fraud, misrepresentation, or other
misconduct. All parties to the arbitration shall share equally in the
payment of payment of the fee and expenses of the arbitrator.
arbllr'""r "(iv) Notwithstanding any other provision of this Act, if the
Administrator determines that a registrant, within the time re-
quired by the Administrator, has failed to take appropriate steps
to secure the data required under this subparagraph, to par-
ticipate in a procedure for reaching agreement concerning a joint
data development arrangement under this subparagraph or in an
arbitration proceeding as required by this subparagraph, or to
comply with the terms of an agreement or arbitration decision
concerning a joint data development arrangement under this sub-
paragraph, the Administrator may issue a notice of intent to sus-
pend such registrant's registration of the pesticide for which addi-
tional data is required. The Administrator may include in the
notice of intent to suspend such provisions as the Administrator
deems appropriate concerning the continued sale and use of ex-
isting stocks of such pesticide. Any suspension proposed under
this subparagraph shall become final and effective at the end of
thirty days from receipt by the registrant of the notice of intent to
suspend, unless during that time a request for hearing is made by
a person adversely affected by the notice or the registrant has
satisfied the Administrator that the registrant has complied fully
Hearing with the requirements that served as a basis for the notice of in-
tent to suspend. If a hearing is requested, a hearing shall be con-
7 use i36d ducted under section 6(d) of this Act: Provided, That the only
matters for resolution at that hearing shall be whether the
registrant has failed to take the action that served as the basis for
the notice of intent to suspend the registration of the pesticide for
which additional data is required, and whether the Ad-
ministrator's determination with respect to the disposition of ex-
isting stocks is consistent with this Act. If a hearing is held, a deci-
sion after completion of such hearing shall be final. Notwith-
standing any other provision of this Act, a hearing shall be held
and a determination made within seventy-five days after receipt of
a request for such hearing. Any registration suspended under this
subparagraph shall be reinstated by the Administrator if the Ad-
ministrator determines that the registrant has compiled fully with
the requirements that served as a basis for the suspension of the
registration.
"(v) Any data submitted under this subparagraph shall be subject to the
provisions of subsection (c)(l)(D) of this section. Whenever such data are sub-
mitted jointly by two or more registrants, an agent shall be agreed on at the
time of the joint submission to handle any subsequent data compensation mat-
ters for the joint submitters of such data.".
10
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"(C) Simplified procedures.—Within nine months after date of p L 95396,
enactment of this subparagraph, the Administrator shall by regula- 92 Sldl 824
tion, prescribe simplified procedures for the registration of
pesticides, which shall include the provisions of subparagraph (D) of
this paragraph.
"(D) Exemption.—No applicant for registration of a pesticide PI 95-396,
who proposes to purchase a. registered pesticide from another pro- 92 Slal 824
ducer in order to formulate such purchased pesticide into an end-use
product shall be required to—
"(i) submit or cite data pertaining to the safety of such pur-
chased product; or
"(ii) offer to pay reasonable compensation otherwise required
by paragraph (1)(D) of this subsection for the use of any such
data.".
"(3) Time for acting with respect to application.—The Ad-
ministrator shall review the data after receipt of the application and
shall, as expeditiously as possible, either register the pesticide in accor-
dance with paragraph (5), or notify the applicant of his determination
that it does not comply with the provisions of the Act in accordance
with paragraph (6).
"(4) Notice of application.—The Administrator shall publish in the Publication m
Federal Register, promptly after receipt of the statement and other data Fcderal Ree|sl"
required pursuant to paragraphs (1) and (2), a notice of each application
for registration of any pesticide if it contains any new active ingredient
or if it would entail a changed use pattern. The notice shall provide for a
period of 30 days in which any Federal agency or any other interested
person may comment.
"(5) Approval of registration.—The Administrator shall register a
pesticide if he determines that, when considered with any restrictions
imposed under subsection (d)—
"(A) its composition is such as to warrant the proposed claims for
it;
"(B) its labeling and other material required to be submitted com-
ply with the requirements of this Act;
"(C) it will perform its intended function without unreasonable
adverse effects on the environment; and
"(D) when used in accordance with widespread and commonly
recognized practice it will not generally cause unreasonable adverse
effects on the environment.
The Administrator shall not make any lack of essentiality a criterion for
denying registration of any pesticide. Where two pesticides meet the re-
quirements of this paragraph, one should not be registered in preference
to the other. In considering an application for the registration of a PL 95-396,
pesticide, the Administrator may waive data requirements pertaining to 92 Slal 825
efficacy, in which event the Administrator may register the pesticide
without determining that the pesticide's composition is such as to war-
rant proposed claims of efficacy. If a pesticide is found to be efficacious
by any State under section 24(c) of this Act, a presumption is established 7 use i36v
that the Administrator shall waive data requirements pertaining to ef-
ficacy for use of the pesticide in such State.
"(6) Denial of registration.—If the Administrator determines that
the requirements of paragraph (5) for registration are not satisfied, he
shall notify the applicant for registration of his determination and of his
reasons (including the factual basis) therefor, and that, unless the appli-
cant corrects the conditions and notifies the Administrator thereof dur-
ing the 30-day period beginning with the day after the date on which the
applicant receives the notice, the Administrator may refuse to register
the pesticide. Whenever the Administrator refuses to register a
pesticide, he shall notify the applicant of his decision and of his reasons
(including the factual basis) therefor. The Administrator shall promptly Publication m
publish in the Federal Register notice of such denial of registration and Federal Res'«"
11
-------
the reasons therefor. Upon such notification, the applicant for registra-
tion or other interested person with the concurrence of the applicant
shall have the same remedies as provided for in section 6.
PL 95396, "(7) Registration under special circumstances.—Notwithstanding the
92 Stal 825 provisions of subsection (c)(5) of this section—
"(A) The Administrator may conditionally register or amend the
registration of a pesticide if the Administrator determines that (i) the
pesticide and proposed use are identical or substantially similar to
any currently registered pesticide and use thereof, or differ only in
ways that would not significantly increase the risk of unreasonable
adverse effects on the environment, and (ii) approving the registra-
tion or amendment in the manner proposed by the applicant would
not significantly increase the risk of any unreasonable adverse effect
on the environment. An applicant seeking conditional registration or
amended registration under this subparagraph shall submit such data
as would be required to obtain registration of a similar pesticide
under subsection (c)(5) of this section: Provided, That, if the appli-
cant is unable to submit an item of data because it has not yet been
generated, the Administrator may register or amend the registration
of the pesticide under such conditions as will require the submission
of such data not later than the time such data are required to be sub-
mitted with respect to similar pesticides already registered under this
Act.
"(B) The Administrator may conditionally amend the registration
of a pesticide to permit additional uses of such pesticide notwith-
standing that data concerning the pesticide may be insufficient to
support an unconditional amendment, if the Administrator deter-
mines that (i) the applicant has submitted satisfactory data pertaining
to the proposed additional use, and (ii) amending the registration in
the manner proposed by the applicant would not significantly in-
crease the risk of any unreasonable adverse effect on the environ-
ment. Notwithstanding the foregoing provisions of this subpara-
graph, no registration of a pesticide may be amended to permit an
additional use of such pesticide if the Administrator has issued a
notice stating that such pesticide, or any ingredient thereof, meets or
exceeds risk criteria associated in whole or in part with human
dietary exposure enumerated in regulations isued under this Act, and
during the pendency of any risk-benefit evaluation initiated by such
notice, if (i) the additional use of such pesticide involves a major
food or feed crop, or (ii) the additional use of such pesticide involves
a minor food or feed crop and the Administrator determines, with
the concurrence of the Secretary of Agriculture, there is available an
effective alternative pesticide that does not meet or exceed such risk
criteria. An applicant seeking amended registration under this sub-
paragraph shall submit such data as would be required to obtain
registration of a similar pesticide under subsection (c)(5) of this sec-
tion: Provided, That, if the applicant is unable to submit an item of
data (other than data pertaining to the proposed additional use)
because it has not yet been generated, the Administrator may amend
the registration under such conditions as will require the submission
of such data not later than the time such data are required to be sub-
mitted with respect to similar pesticides already registered under this
Act.
"(C) The Administrator may conditionally register a pesticide
containing an active ingredient not contained in any currently
registered pesticide for a period reasonably sufficient for the genera-
tion and submission of required data (which are lacking because a
period reasonably sufficient for generation of the data has not
elapsed since the Administrator first imposed the data requirement)
on the condition that by the end of such period the Administrator
receives such data and the data do not meet or exceed risk criteria
enumerated in regulations issued under this Act, and on such other
12
-------
conditions as the Administrator may prescribe: Provided, That a
conditional registration under this subparagraph shall be granted
only if the Administrator determines that use of the pesticide during
such period will not cause any unreasonable adverse effect on the en-
vironment, and that use of the pesticide is, in the public interest.
"(8) Interim administrative review.—Notwithstanding any other pro- P L 95-396,
vision of this Act, the Administrator may not initiate a public interim 92 Slal 826
administrative review process to develop a risk-benefit evaluation of the
ingredients of a pesticide or any of its uses prior to initiating a formal
action to cancel, suspend, or deny registration of such pesticide, re-
quired under this Act, unless such interim administrative process is
based on a validated test or other significant evidence raising prudent
concerns of unreasonable adverse risk to man or to the environment.
Notice of the definition of the terms 'validated test' and 'other signifi- Nonce ot
cant evidence' as used herein shall be published by the Administrator in pu^™!,'"™ m
the Federal Register." Federal RcgM
'(d) Classification of Pesticides.—
"(1) Classification for genera/ use, restricted use, or both.—
"(A) As a part of the registration of a pesticide the Administrator
shall classify it as being for general use or for restricted use, provided
that if the Administrator determines that some of the uses for which
the pesticide is registered should be for general use and that other
uses for which it is registered should be for restricted use, he shall
classify it for both general use and restricted use. Pesticide uses may P L 95-196,
be classified by regulation on the initial classification, and registered 92 Slal 826
pesticides may be classified prior to reregistration. If some of the
uses of the pesticide are classified for general use and other uses are
classified for restricted use, the directions relating to its general uses
shall be clearly separated and distinguished from those directions
relating to its restricted uses: Provided, however, That the Ad-
ministrator may require that its packaging and labeling for restricted
uses shall be clearly distinguishable from its packaging and labeling
for general uses.
"(B) If the Administrator determines that the pesticide, when ap-
plied in accordance with its directions for use, warnings and cautions
and for the uses for which it is registered, or for one or more of such
uses, or in accordance with a widespread and commonly recognized
practice, will not generally cause unreasonable adverse effects on the
environment, he will classify the pesticide, or the particular use or
uses of the pesticide to which the determination applies, for general
use.
"(C) If the Administrator determines that the pesticide, when ap-
plied in accordance with its directions for use, warnings and cautions
and for the uses for which it is registered, or for one or more of such
uses, or in accordance with a widespread and commonly recognized
practice, may generally cause, without additional regulatory restric-
tions, unreasonable adverse effects on the environment, including
injury to the applicator, he shall classify the pesticide, or the par-
ticular use or uses to which the determination applies, for restricted
use:
"(i) If the Administrator classifies a pesticide, or one or more
uses of such pesticide, for restricted use because of a determina-
tion that the acute dermal or inhalation toxicity of the pesticide
presents a hazard to the applicator or other persons, the pesticide
shall be applied for any use to which the restricted classification
applies only by or under the direct supervision of a certified ap-
plicator.
"(ii) If the Administrator classifies a pesticide, or one or more
uses of such pesticide, for restricted use because of a determina-
tion that its use without additional regulatory restriction may
cause unreasonable adverse effects on the environment, the
pesticide shall be applied for any use to which the determination
13
-------
applies only by or under the direct supervision of a certified ap-
plicator, or subject to such other restrictions as the Administrator
may provide by regulation. Any such regulation shall be
reviewable in the appropriate court of appeals upon petition of a
person adversely affected filed within 60 days of the publication
of the regulation in final form.
publication m "(2) Change in classification.—If the Administrator determines that
rederai Register a cnange jn (ne classification of any use of a pesticide from general use
to restricted use is necessary to prevent unreasonable adverse effects on
the environment, he shall notify the registrant of such pesticide of such
determination at least forty-five days before making the change and
shall publish the proposed change in the Federal Register. The
registrant, or other interested person with the concurrence of the
7 use i36d, registrant, may seek relief from such determination under section 6(b).
p L 95-396, "(3) Change in classification from restricted use to general use.—The
92 Stal 827 registrant of any pesticide with one or more uses classified for restricted
use may petition the Administrator to change any such classification
from restricted to general use. Such petition shall set out the basis for
the registrant's position that restricted use classification is unnecessary
because classification of the pesticide for general use would not cause
unreasonable adverse effects on the environment. The Administrator,
within sixty days after receiving such petition, shall notify the registrant
whether the petition has been granted or denied. Any denial shall con-
tain an explanation therefor and any such denial shall be subject to
7 use n6n judicial review under section 16 of this Act.
"(e) Products With Same Formulation and Claims.— Products which have
the same formulation, are manufactured by the same person, the labeling of
which contains the same claims, and the labels of which bear a designation
identifying the product as the same pesticide may be registered as a single
pesticide; and additional names and labels shall be added to the registration by
supplemental statements.
"(f) Miscellaneous.—
"(1) Effect of change of labeling or formulation.—If the labeling or
formulation for a pesticide is changed, the registration shall be amended
to reflect such change if the Administrator determines that the change
will not violate any provision of this Act.
"(2) Registration not a defense.—In no event shall registration of an
article be construed as a defense for the commission of any offense
under this Act: Provided, That as long as no cancellation proceedings
are in effect registration of a pesticide shall be prima facie evidence that
the pesticide, its labeling and packaging comply with the registration
provisions of the Act.
"(3) Authority to consult other Federal agencies.—In connection
with consideration of any registration or application for registration
under this section, the Administrator may consult with any other
Federal agency.
PL 95396. "(g) Reregistration of Pesticides.—The Administrator shall accomplish the
92 Sul 827 reregistration of all pesticides in the most expeditious manner practicable:
Provided, That, to the extent appropriate, any pesticide that results in a
postharvest residue in or on food or feed crops shall be given priority in the
reregistration process.
7usci36b "SEC. 4. USE OF RESTRICTED USE PESTICIDES; CERTIFIED AP-
PLICATORS.
"(a) Certification Procedure.—
p L 95-3% "(1) Federal certification.—In any State for which a State plan for
92 Slal 827 applicator certification has not been approved by the Administrator, the
Administrator, in consultation with the Governor of such State, shall
conduct a program for the certification of applicators of pesticides: Pro-
vided, That such program shall conform to the requirements imposed
upon the States under the provisions of subsection (a)(2) of this section
14
-------
and shall not require private applicators to take any examination to
establish competency in the use of pesticides. Prior to the implementa-
tion of the program, the Administrator shall publish in the Federal
Register for review and comment a summary of the Federal plan for ap-
plicator certification and shall make generally available within the State
copies of the plan. The Administrator shall hold public hearings at one Public hearings
or more locations within the State if so requested by the Governor of
such State during the thirty days following publication of the Federal
Register notice inviting comment on the Federal plan. The hearings shall
be held within thirty days following receipt of the request from the
Governor. In any State in which the Administrator conducts a certifica-
tion program, the Administrator may require any person engaging in the
commercial application, sale, offering for sale, holding for sale, or
distribution of any pesticide one or more uses of which have been
classified for restricted use to maintain such records and submit such
reports concerning the commercial application, sale, or distribution of
such pesticide as the Administrator may by regulation prescribe. Subject sundard?
to paragraph (2), the Administrator shall prescribe standards for the
certification of applicators of pesticides. Such standards shall provide
that to be certified, an individual must be determined to be competent
with respect to the use and handling of pesticides, or to the use and
handling of the pesticide or class of pesticides covered by such in-
dividual's certification: Provided, however, That the certification stan- p L 94-140,
dard for a private applicator shall, under a State plan submitted for ap- 89 Slat 753
proval, be deemed fulfilled by his completing a certification form.
The Administrator shall further assure that such form contains ade-
quate information and affirmations to carry out the intent of this Act,
and may include in the form an affirmation that the private applicator
has completed a training program approved by the Administrator so
long as the program does not require the private applicator to take, pur-
suant to requirement prescribed by the Administrator, any examination
to establish competency in the use of the pestiscide. The Administrator
may require any pesticide dealer participating in a certification program
to be licensed under a State licensing program approved by him.
"(2) State certification.—If any State, at any time, desires to certify
applicators of pesticides, the Governor of such State shall submit a State
plan for such purpose. The Administrator shall approve the plan sub-
mitted by any State, or any modification thereof, if such plan in his
judgment—
"(A) designates a State agency as the agency responsible for ad-
ministering the plan throughout the State;
"(B) contains satisfactory assurances that such agency has or will
have the legal authority and qualified personnel necessary to carry
out the plan;
"(C) gives satisfactory assurances that the State will devote ade-
quate funds to the administration of the plan;
"(D) provides that the State agency will make such reports to the
Administrator in such form and containing such information as the
Administrator may from time to time require; and
"(E) contains satisfactory assurances that State standards for the
certification of applicators of pesticides conform with those stan-
dards prescribed by the Administrator under paragraph (1).
Any State certification program under this section shall be maintained
in accordance with the State plan approved under this section.
"(b) State Plans.—If the Administrator rejects a plan submitted under this Hearing
paragraph, he shall afford the State submitting the plan due notice and oppor-
tunity for hearing before so doing. If the Administrator approves a plan sub-
mitted under this paragraph, then such State shall certify applicators of
pesticides with respect to such State. Whenever the Administrator determines
that a State is not administering the certification program in accordance with
the plan approved under this section, he shall so notify the State and provide
for a hearing at the request of the State, and, if appropriate corrective action is
15
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P.L. 94-140,
89 Stal 754
not taken within a reasonable time, not to exceed ninety days, the Ad-
ministrator shall withdraw approval of such plan.
"(c) Instruction in Integrated Pest Management Techniques.—Standards
prescribed by the Administrator for the certification of applicators of
pesticides under subsection (a), and the State plans submitted to the Ad-
ministrator under subsection (a) and (b), shall include provisions for making
instructional materials concerning integrated pest management techniques
available to individuals at their request in accordance with the provisions of
section 23(c) of this Act, but such plans may not require that any individual
receive instruction concerning such techniques or be shown to be competent
with respect to the use of such techniques. The Administrator and States im-
plementing such plans shall provide that all interested individuals are notified
of the availability of such instructional materials."
P L 95-396,
92 Slac 828
7 USC 136a
7 USC !36a
P L 94-140,
89 Slat 754
"SEC. 5. EXPERIMENTAL USE PERMITS.
"(a) Issuance.—Any person may apply to the Administrator for an ex-
perimental use permit for a pesticide. The Administrator shall review the ap-
plication. After completion of the review, but not later than one hundred and
twenty days after receipt of the application and all required supporting data,
the Administrator shall either issue the permit or notify the applicant of the
Administrator's determination not to issue the permit and the reasons
therefor. The applicant may correct the application or request a waiver of the
conditions for such permit within thirty days of receipt by the applicant of
such notification. The Administrator may issue an experimental use permit
only if the Administrator determines that the applicant needs such permit in
order to accumulate information necessary to register a pesticide under section
3 of this Act. An application for an experimental use permit may be filed at
any time.
"(b) Temporary Tolerance Level.—If the Administrator determines that
the use of a pesticide may reasonably be expected to result in any residue on or
in food or feed, he may establish a temporary tolerance level for fhe residue of
the pesticide before issuing the experimental use permit.
"(c) Use Under Permit.—Use of a pesticide under an experimental use per-
mit shall be under the supervision of the Adminstrator, and shall be subject to
such terms and conditions and be for such period of time as the Administrator
may prescribe in the permit.
"(d) Studies.—When any experimental use permit is issued for a pesticide
containing any chemical or combination of chemicals which has not been in-
cluded in any previously registered pesticide, the Administrator may specify
that studies be conducted to detect whether the use of the pesticide under the
permit may cause unreasonable adverse effects on the environment. All results
of such studies shall be reported to the Administrator before such pesticide
may be registered under section 3.
"(e) Revocation.—The Administrator may revoke any experimental use
permit, at any time, if he finds that its terms or conditions are being violated,
or that its terms and conditions are inadequate to avoid unreasonable adverse
effects on the environment.
"(f) State Issuance of Permits.—Notwithstanding the foregoing provisions
of this section, the Adminsitrator shall,under such terms and conditions as
he may by regulations prescribe, authorize any State to issue an experimental
use permit for a pesticide. All provisions of section 4 relating to State plans
shall apply with equal force to a State plan for the issuance of experimental use
permits under this section.
"(g) Exemption for Agricultural Research Agencies.—Notwithstanding the
foregoing provisions of this section, the Administrator may issue an ex-
perimental use permit for a pesticide to any public or private agricultural
research agency or educational institution which applies for such permit. Each
permit shall not exceed more than a one-year period or such other specific time
as the Administrator may prescribe. Such permit shall be issued under such
terms and conditions restricting the use of the pesticide as the Administrator
\6
-------
may require: Provided, That such pesticide may be used only by such research
agency or educational institution for purposes of experimentation."
"SEC. 6. ADMINISTRATIVE REVIEW; SUSPENSION. 7 isc UM
"(a) Cancellation After Five Years.—
"(1) Procedure.—The Administrator shall cancel the registration of
any pesticide at the end of the five-year period which begins on the date
of its registration (or at the end of any five-year period thereafter) unless
the registrant, or other interested person with the concurrence of the
registrant, before the end of such period, requests in accordance with
regulations prescribed by the Administrator that the registration be con-
tinued in effect: Provided, That the Administrator may permit the con-
tinued sale and use of existing stocks of a pesticide whose registration is
canceled under this subsection or subsection (b) to such extent, under
such conditions, and for such uses as he may specify if he determines
that such sale or use is not inconsistent with the purposes of this Act and
will not have unreasonable adverse effects on the environment. The Ad-
ministrator shall publish in the Federal Register, at least 30 days prior to pubin.ai.on m
the expiration of such five-year period, notice that the registration will Federal Re8'ster
be canceled if the registrant or other interested person with the concur-
rence of the registrant does not request that the registration be con-
tinued in effect.
"(2) Information.—If at any time after the registration of a pesticide
the registrant has additional factual information regarding
unreasonable adverse effects on the environment of the pesticide, he
shall submit such information to the Administrator.
"(b) Cancellation and Chance in Classification.—If it appears to the Ad-
ministrator that a pesticide or its labeling or other material required to be sub-
mitted does not comply with the provisions of this Act or when used in accor-
dance with widespread and commonly recognized practice, generally causes
unreasonable adverse effects on the environment, the Administrator may issue
a notice of his intent either—
"(1) to cancel its registration or to change its classification together
with the reasons (including the factual basis) for his action, or
"(2) to hold a hearing to determine whether or not its registration Hearmg
should be canceled or its classification changed.
Such notice shall be sent to the registrant and made public. In determining p i 94-140,
whether to issue any such notice, the Administrator shall include among those 89 Slal 751
factors to be taken into account the impact of the action proposed in such
notice on production and prices of agricultural commodities, retail food
prices, and otherwise on the agricultural economy. At least 60 days prior to
sending such notice to the registrant or making public such notice, whichever
occurs first, the Administrator shall provide the Secretary of Agriculture with
a copy of such notice and an analysis of such impact on the agricultural
economy. If the Secretary comments in writing to the Administrator regarding pubin.at.on m
the notice and analysis within 30 days after receiving them, the Administrator Hderal RvfM™
shall publish in the Federal Register (with the notice) the comments of
the Secretary and the response of the Administrator with regard to the
Secretary's comments. If the Secretary does not comment in writing to the Ad-
ministrator regarding the notice and analysis within 30 days after receiving
them, the Administrator may notify the registrant and make public the notice
at any time after such 30-day period notwithstanding the foregoing 60-day
time requirement. The time requirements imposed by the preceding 3
sentences may be waived or modified to the extent agreed upon by the Ad-
ministrator and the Secretary. Notwithstanding any other provision of this
subsection (b) and section 25(d), in the event that the Administrator deter- • use i36»
mines that suspension of a pesticide registration is necessary to prevent an im-
minent hazard to human health, then upon such a finding the Administrator
may waive the requirement of notice to and consultation with the Secretary of
Agriculture pursuant to subsection (b) and of submission to the Scientific Ad-
17
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P L. 95-396,
92 Slat 828
P L 94-140,
89Stal 751
80 Slat 381,
81 Slat 54
5 USC 551
visory Panel pursuant to section 25(d) and proceed in accordance with subsec-
tion (c). The proposed action shall become final and effective at the end of 30
days from receipt by the registrant, or publication, of a notice issued under
paragraph (1), whichever occurs later, unless within that time either (i) the
registrant makes the necessary corrections, if possible, or (ii) a request For a
hearing is made by a person adversely affected by the notice. In the event a
hearing is held pursuant to such a request or to the Administrator's determina-
tion under paragraph (2), a decision pertaining to registration or classification
issued after completion of such hearing shall be final.
In taking any final action under this subsection, the Administrator shall
consider restricting a pesticide's use or uses as an alternative to cancellation
and shall fully explain the reasons for these restrictions, and shall include
among those factors to be taken into account the impact of such final action
on production and prices of agricultural commodities, retail food prices, and
otherwise on the agricultural economy, and he shall publish in the Federal
Register an analysis of such impact.
"(c) Suspension.—
"(1) Order.—If the Administrator determines that action is necessary
to prevent an imminent hazard during the time required for cancellation
or change in classification proceedings he may, by order, suspend the
registration of the pesticide immediately. No order of suspension may
be issued unless the Administrator has issued or at the same time issues
notice of his intention to cancel the registration or change the classifica-
tion of the pesticide.
Except as provided in paragraph (3), the Administration shall notify
the registrant prior to issuing any suspension order. Such notice shall in-
clude findings pertaining to the question of 'imminent hazard'. The
registrant shall then have an opportunity, in accordance with the provi-
sions of paragraph (2), for an expedited hearing before the Agency on
the question of whether an imminent hazard exists.
"(2) Expedite hearing.—If no request for a hearing is submitted to
the Agency within five days of the registrant's receipt of the notification
provided for by paragraph (1), the suspension order may be issued and
shall take effect and shall not be reviewable by a court. If a hearing is re-
quested, it shall commence within five days of the receipt of the request
for such hearing unless the registrant and the Agency agree that it shall
commence at a later time. The hearing shall be held in accordance with
the provisions of subchapter II of title 5 of the United States Code, ex-
cept that the presiding officer need not be a certified hearing examiner.
The presiding officer shall have ten days from the conclusion of the
presentation of evidence to submit recommended findings and conclu-
sions to the Administrator, who shall then have seven days to render a
final order on the issue of suspension.
"(3) Emergency order.— Whenever the Administrator determines
that an emergency exists that does not permit him to hold a hearing
before suspending, he may issue a suspension order in advance of
notification to the registrant. In that case, paragraph (2) shall apply ex-
cept that (i) the order of suspension shall be in effect pending the ex-
peditious completion of the remedies provided by that paragraph and
the issuance of a final order on suspension, and (ii) no party other than
the registrant and the Agency shall participate except that any person
adversely affected may file briefs within the time allotted by the Agen-
cy's rules. Any person so filing briefs shall be considered a party to such
proceeding for the purpose of section 16(b).
"(4) Judicial review.— A final order on the question of suspension
following a hearing shall be reviewable in accordance with Section 16 of
this Act, notwithstanding the fact that any related cancellation pro-
ceedings have not been completed. Petitions to review orders on the
issue of suspension shall be advanced on the docket of the courts of ap-
peals. Any order of suspension entered prior to a hearing before the Ad-
ministrator shall be subject to immediate review in an action by the
registrant or other interested person with the concurrence of the
18
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registrant in an appropriate district court, solely to determine whether
the order of suspension was arbitrary, capricious or an abuse of discre-
tion, or whether the order was issued in accordance with the procedures
established by law. The effect of any order of the court will be only to
stay the effectiveness of the suspension order, pending the Ad-
ministrator's final decision with respect to cancellation or change in
classification. This action may be maintained simultaneously with any
administrative review proceeding under this section. The commence-
ment of proceedings under this paragraph shall not operate as a stay of
order, unless ordered by the court.
"(d) Public Hearings and Scientific Review.—In the event a hearing is re-
quested pursuant to subsection (b) or determined upon by the Administrator
pursuant to subsection (b), such hearing shall be held after due notice for the
purpose of receiving evidence relevant and material to the issues raised by the
objections filed by the applicant or other interested parties, or to the issues
stated by the Administrator, if the hearing is called by the Administrator
rather than by the filing of objections. Upon a showing of relevance and
reasonable scope of evidence sought by any party to a public hearing, the
Hearing Examiner shall issue a subpoena to compel testimony or production of subpoena
documents from any person. The Hearing Examiner shall be guided by the
principles of the Federal Rules of Civil Procedure in making any order for the 28 use app
protection of the witness or the content of documents produced and shall
order the payment of reasonable fees and expenses as a condition to requiring
testimony of the witness. On contest, the subpoena may be enforced by an ap-
propriate United States district court in accordance with the principles stated
herein. Upon the request of any party to a public hearing and when in the
Hearing Examiner's judgment it is necessary or desirable, the Hearing Ex-
aminer shall at any time before the hearing record is closed refer to a Commit-
tee of the National Academy of Sciences the relevant questions of scientific
fact involved in the public hearing. No member of any committee of the Na-
tional Academy of Sciences established to carry out the functions of this sec-
tion shall have a financial or other conflict of interest with respect to any mat-
ter considered by such committee. The Committee of the National Academy Report
of Sciences shall report in writing to the Hearing Examiner within 60 days after
such referral on these questions of scientific fact. The report shall be made
public and shall be considered as part of the hearing record. The Ad-
ministrator shall enter into appropriate arrangements with the National
Academy of Sciences to assure an objective and competent scientific review of
the questions presented to Committees of the Academy and to provide such
other scientific advisory services as may be required by the Administrator for
carrying out the purposes of this Act. As soon as practicable after completion
of the hearing (including the report of the Academy) but not later than 90 days
thereafter, the Administrator shall evaluate the data and reports before him
and issue an order either revoking his notice of intention issued pursuant to
this section, or shall issue an order either canceling the registration, changing
the classification, denying the registration, or requiring modification of the
labeling or packaging of the article. Such order shall be based only on substan-
tial evidence of record of such hearing and shall set forth detailed findings of
fact upon which the order is based.
"(e) Conditional Registration.— PL 95-395,
"(1) The Administrator shall issue a notice of intent to cancel a 92Stat 828
registration issued under section 3(c)(7) of this Act if (A) the Ad- Nonce
ministrator, at any time during the period provided for satisfaction of i use i36a
any condition imposed, determines that the registrant has failed to in-
itiate and pursue appropriate action toward fulfilling any condition im-
posed, or (B) at the end of the period provided for satisfaction of any
condition imposed, that condition has not been met: Provided, That the
Administrator may permit the continued sale and use of existing stocks
of a pesticide whose conditional registration has been canceled under
this subsection to such extent, under such conditions, and for such uses
as the Administrator may specify if the Administrator determines that
such sale or use is not inconsistent with the purposes of this Act and will
19
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not have unreasonable adverse effects on the environment.
"(2) A cancellation proposed under this subsection shall become
final and effective at the end of thirty days from receipt by the registrant
of the notice of intent to cancel unless during that time a request for
hearing is made by a person adversely affected by the notice. If a hear-
ing is requested, a hearing shall be conducted under subsection (d) of
this section: Provided, That the only matters for resolution at that hear-
ing shall be whether the registrant has initiated and pursued appropriate
action to comply with the condition or conditions within the time pro-
vided or whether the condition or conditions have been satisfied within
the time provided, and whether the Administrator's determination with
respect to the disposition of existing stocks is consistent with this Act. A
decision after completion of such hearing shall be final. Notwithstand-
ing any other provision of this section, a hearing shall be held and a
determination made within seventy-five days after receipt of a request
for such hearing.
"(0 Judicial Review. —Final orders of the Administrator under this section
shall be subject to judicial review pursuant to section 16.
7 USC 136e
P.L. 95-396,
92 Slat 829
92 Stat 829
"SEC. 7. REGISTRATION OF ESTABLISHMENTS.
"(a) Requirement.—No person shall produce any pesticide subject to this
Act or active ingredient used in producing a pesticide subject to this Act in any
State unless the establishment in which it is produced is registered with the Ad-
ministrator. The application for registration of any establishment shall include
the name and address of the establishment and of the producer who operates
such establishment.
"(b) Registration.—Whenever the Administrator receives an application
under subsection (a), he shall register the establishment and assign it an
establishment number.
"(c) Information Required.—
"(1) Any producer operating an establishment registered under this
section shall inform the Administrator within 30 days after it is
registered of the types and amounts of pesticides and, if applicable, ac-
tive ingredients used in producing pesticides—
"(A) which he is currently producing;
"(B) which he has produced during the past year; and
"(C) which he has sold or distributed during the past year.
The information required by this paragraph shall be kept current and
submitted to the Administrator annually as required under such regula-
tions as the Administrator may prescribe.
"(2) Any such producer shall, upon the request of the Administrator
for the purpose of issuing a stop sale order pursuant to section 13, in-
form him of the name and address of any recipient of any pesticide pro-
duced in any registered establishment which he operates.
"(d) Confidential Records and Information.—Any information submitted
to the Administrator pursuant to subsection (c) other than the names of the
pesticides or active ingredients used in producing pesticides produced, sold, or
distributed at an establishment shall be considered confidential and shall be
subject to the provisions of section 10.
7 use U6f "SEC. 8. BOOKS AND RECORDS.
Regulations "(a) Requirements.—The Administrator may prescribe regulations requir-
ing producers to maintain such records with respect to their operations arid the
pesticides and devices produced as he determines are necessary for the effec-
tive enforcement of this Act. No records required under this subsection shall
extend to financial data, sales data other than shipment data, pricing data,
personnel data, and research data (other than data relating to registered pesti-
cides or to a pesticide for which an application for registration has been filed).
20
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"(b) Inspection.—For the purposes of enforcing the provisions of this Act,
any producer, distributor, carrier, dealer, or any other person who sells or of-
fers for sale, delivers or offers for delivery any pesticide or device subject to
this Act, shall, upon request of any officer or employee of the Environmental
Protection Agency or of any State or political subdivision, duly designated by
the Administrator, furnish or permit such person at all reasonable times to
have access to, and to copy: (1) all records showing the delivery, movement, or
holding of such pesticide or device, including the quantity, the date of ship-
ment and receipt, and the name of the consignor and consignee; or (2) in the
event of the inability of any person to produce records containing such infor-
mation, all other records and information relating to such delivery, move-
ment, or holding of the pesticide or device. Any inspection with respect to any
records and information referred to in this subsection shall not extend to
financial data, sales data other than shipment data, pricing data, personnel
data, and research data (other than data relating to registered pesticides or to a
pesticide for which an application for registration has been filed).
Before undertaking an inspection under this subsection, the officer or p i 95-396,
employee must present to the owner, operator, or agent in charge of the 92 Slat 829
establishment or other place where pesticides or devices are held for distribu-
tion or sale, appropriate credentials and a written statement as to the reason
for the inspection, including a statement as to whether a violation of the law is
suspected. If no violation is suspected, an alternate and sufficient reason shall
be given in writing. Each such inspection shall be commenced and completed
with reasonable promptness.
"SEC. 9. INSPECTION OF ESTABLISHMENTS, ETC.
"(a) In General.—For purposes of enforcing the provisions of this Act, of-
ficers or employees duly designated by the Administrator are authorized to
enter at reasonable times, any establishment or other place where pesticides or
devices are held for distribution or sale for the purpose of inspecting and ob-
taining samples of any pesticides or devices, packaged, labeled , and released
for shipment, and samples of any containers or labeling for such pesticides or
devices.
Before undertaking such inspection, the officers or employees must
present to the owner, operator, or agent in charge of the establishment or
other place where pesticides or devices are held for distribution or sale, ap-
propriate credentials and a written statement as to the reason for the inspec-
tion, including a statement as to whether a violation of the law is suspected. If
no violation is suspected, an alternate and sufficient reason shall be given in
writing. Each such inspection shall be commenced and completed with
reasonable promptness. If the officer or employee obtains any samples, prior
to leaving the premises, he shall give to the owner, operator, or agent in charge
a receipt describing the samples obtained and, if requested, a portion of each
such sample equal in volume or weight to the portion retained. If an analysis is
made of such samples, a copy of the results of such analysis shall be furnished
promptly to the owner, operator, or agent in charge.
"(b) Warrants.—For purposes of enforcing the provisions of this Act and
upoaa showing to an officer or court of competent jurisdiction that there is
reason to believe that the provisions of this Act have been violated, officers or
employees duly designated by the Administrator are empowered to obtain and
to execute warrants authorizing—
"(1) entry for the purpose of this section;
"(2) inspection and reproduction of all records showing the quantity,
date of shipment, and the name of consignor and consignee of any
pesticide or device found in the establishment which is adulterated,
misbranded, not registered (in the case of a pesticide) or otherwise in
violation of this Act and in the event of the inability of any person to
produce records containing such information, all other records and m-
21
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formation relating to such delivery, movement, or holding of the
pesticide or device; and
"(3) the seizure of any pesticide or device which is in violation of this
Act.
"(c) Enforcement.—
"(1) Certification of facts to attorney general.— The examination of
pesticides or devices shall be made in the Environmental Protection
Agency or elsewhere as the Administrator may designate for the purpose
of determining from such examinations whether they comply with the
requirements of this Act. If it shall appear from any such examination
that they fail to comply with the requirements of this Act, the Ad-
ministrator shall cause notice to be given to the person against whom
criminal or civil proceedings are contemplated. Any person so notified
shall be given an opportunity to present his views, either orally O" in
writing, with regard to such contemplated proceedings, and if in the opi-
nion of the Administrator it appears that the provisions of this Act have
been violated by such person, then the Administrator shall certify the
facts to the Attorney General, with a copy of the results of the analysis
or the examination of such pesticide for the institution of a criminal pro-
7 use i36i ceeding pursuant to section 14(b) or a civil proceeding under section
14(a), when the Administrator determines that such action will be suffi-
cient to effectuate the purposes of this Act.
"(2) Notice not required.—The notice of contemplated proceedings
and opportunity to present views set forth in this subsection are not
prerequisites to the institution ot any proceeding by the Attorney
General.
"(3) Warning notices. — Nothing in this Act shall be construed as re-
quiring the Administrator to institute proceedings for prosecution of
minor violations of this Act whenever he believes that the public intei est
will be adequately served by a suitable written notice of warning.
7 use i36h "SEC. 10. PROTECTION OF TRADE SECRETS AND OTHER INFOR-
MATION.
"(a) In General.—In submitting data required by this Act, the applicant
may (1) clearly mark any portions thereof which in his opinion are trade
secrets or commercial or financial information and (2) submit such marked
materials separately from other material lequired to be submitted under this
Act.
"(b) Disclosure.—Nothwithstanding any other provision of this Act, and
subject to the limitations in subsections (d) and (e) of this section the Ad-
ministrator shall not make public information which in his judgment contains
or relates to trade secrets or commercial or financial information obtained
from a person and privileged or confidential, except that, when necessary to
carry out the provisions of this Act, information relating to formulas of pro-
ducts acquired by authorization of this Act may be revealed to any Federal
agency consulted and may be revealed at a public hearing or in findings of fuel
issued by the Administrator.
"(c) Disputes.— If the Administrator proposes to release foi inspection in-
formation which the applicant or registrant believes to be protected from
disclosure under subsection (b), he shall notify the applicant or registrant, in
writing, by certified mail. The Administrator shall not thereafter make
available for inspection such data until thirty days after receipt of the notice by
the applicant or registrant. During this period, the applicant or registrant may
institute an action in an appropriate district court for a declaratory judgment
as lo whether such information is subject to protection under subsection (b).
PL 95-396, "(d) Limitations.—
92Stal 83° "(1) All information concerning the objectives, methodology,
information, results, or significance of any test or experiment performed on 01 with a
availability
to public
22
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registered or previously registered pesticide or its separate ingredients,
impurities, or degradation products, and any information concerning
the effects ot such pesticide on any organism or the behavior of such
pesticide in the environment, including, but not limited to, data on safe-
ty to fish and wildlife, humans and other mammals, plants, animals,
and soil, and studies on persistence, translocation and fate in the en-
vironment, and metabolism, shall be available for disclosure to the
public: Provided, That the use of such data for any registration purpose
shall be governed by section 3 of this Act: Provided further, That this 71 st i36a
paragraph does not authorize the disclosure of any information that —
"(A) discloses maufactunng or quality control processes,
"(B) discloses the details of any methods for testing, detecting, or
measuring the quantity of any delibrately added inert ingredient of a
pesticide, or
"(C) discloses the identity or percentage quantity of any
deliberately added inert ingredient of a pesticide, unless the Adminis-
trator has first determined that disclosure is necessary to protect
against an unreasonable risk of injury to health or the environment.
"(2) Information concerning production, distribution, sale, or inven-
tories of a pesticide that is otherwise entitled to confidential treatment
under subsection (b) of this section may be publicly disclosed in connec-
tion with a public proceeding to determine whether a pesticide, or any
ingredient of a pesticide, causes unreasonable adverse effects on health
or the environment, if the Administrator determines that such
disclosure is necessary in the public interest.
"(3) If the Administrator proposes to disclose information described
in clause (A), (B), or (C) of paragraph (1) or in paragraph (2) of this
subsection, the Administrator shall notify by certified mail the submit-
ter of such information of the intent to release such information. The
Administrator may not release such information, without the submit-
ter's consent, until thirty days after the submitter has been furnished
such notice: Provided, That where the Administrator finds that
disclosure of information described in clause (A), (B), (C) of paragraph
(1) of this subsection is necessary to avoid or lessen an imminent and
substantial risk of injury to the public health, the Administrator may set
such shorter period of notice (but not less than ten days) and such
method of notice as the Administrator finds appropriate. During such
period the data submitter may institute an action in an appropriate
district court to enjoin or limit the proposed disclosure. The court shall
give expedited consideration to any such action. The court may enjoin
disclosure, or limit the disclosure or the parties to whom disclosure shall
be made, to the extent that—
"(A) in the case of information described in clause (A), (B), or (C)
of paragraph (1) of this subsection, the proposed disclosure is not re-
quired to protect against an unreasonable risk of injury to health or
the environment; or
"(B) in the case of information described in paragraph (2) of this
subsection, the public interest in availability of the information in the
public proceeding does not outweigh the interests in preserving the
confidentiality of the information.
"(e) Disclosure to Contractors.—Information otherwise protected from PI 95-396,
disclosure to the public subsection (b) of this section may be disclosed to con- 92 Slal 831
tractors with the United States and employees of such contractors if, in the opi-
nion of the Administrator, such disclosure is necessary for the satisfactory per-
formance by the contractor of a contract with the United States for the perfor-
mance of work in connection with this Act and under such conditions as the
Administrator may specify. The Administrator shall require as a condition to
the disclosure of information under this subsection that the person receiving it
take such security precautions respecting the information as the Administrator
shall by regulation prescribe.
"(f) Penalty for disclosure by Federal Employees.— PL 95-196.
92 Slal 831
23
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"(1) Any officer or employee of the United States or former officer
or employee of the United States who, by virtue of such employment or
official position, has obtained possession of, or has access to, material
the disclosure of which is prohibited by subsection (b) of this section,
and who, knowing that disclosure of such material is prohibited by such
subsection, willfully discloses the material in any manner to any person
not entitled to receive it, shall be fined not more than $10,000 or im-
prisoned for not more than one year, or both. Section 1905 of title 18 of
the United States Code shall not apply with respect to the publishing,
divulging, disclosure, or making known of, or making available, infor-
mation reported or otherwise obtained under this Act. Nothing in this
Act shall preempt any civil remedy under State or Federal law for
wrongful disclosure of trade secrets.
"(2) For the purposes of this section, any contractor with the United
States who is furnished information as authorized by subsection (e) of
this section, or any employee of any such contractor, shall be considered
to be an employee of the United States.
PI ss-396, "(g) Disclosure to Foreign and Multinational Pesticide Producers.—
92 Slal 831 "(1) The Administrator shall not knowingly disclose information
submitted by an applicant or registrant under this Act to any employee
or agent of any business or other entity engaged in the production, sale,
or distribution of pesticides in countries other than the United States or
in addition to the United States or to any other person who intends to
deliver such data to such foreign or multinational business or entity
unless the applicant or registrant has consented to such disclosure. The
Administrator shall require an affirmation from any person who intends
to inspect data that such person does not seek access to the data for pur-
poses of delivering it or offering it for sale to any such business or entity
or its agents or employees and will not purposefully deliver or negligent-
ly cause the data to be delivered to such business or entity or its agents
or employees. Notwithstanding any other provision of this subsection,
the Administrator may disclose information to any person in connection
with a public proceeding under law or regulation, subject to restrictions
on the availability of information contained elsewhere in this Act, which
information is relevant to the determination by the Administrator with
respect to whether a pesticide, or any ingredient of a pesticide, causes
unreasonable adverse effects on health or the environment.
Records "(2) The Administrator shall maintain records of the names of per-
sons to whom data are disclosed under this subsection and the persons
or organizations they represent and shall inform the applicant or
registrant of the names and affiliation of such persons.
"(3) Section 1001 of title 18 of the United States Code shall apply to
any affirmation made under paragraph (1) of this subsection.
7 use 136, "SEC. 11. STANDARDS APPLICABLE TO PESTICIDE APPLICATORS.
"(a) In General.—No regulations prescribed by the Administrator for car-
rying out the provisions of this Act shall require any private applicator to
maintain any records or file any reports or other documents.
"(b) Separate Standards.—When establishing or approving standards for
licensing or certification, the Administrator shall establish separate standards
for commercial and private applicators.
7 use i36j "SEC. 12. UNLAWFUL ACTS.
"(a) In General.—
"(1) Except as provided by subsection (b), it shall be unlawful for
24
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any person in any State to distribute, sell, offer for sale, hold for sale,
ship, deliver for shipment, or receive and (having so received) deliver or
offer to deliver, to any person—
"(A) any pesticide which is not registered under section 3, except 7 use B6a,
as provided by section 6(a)(l);
"(B) any registered pesticide if any claims made for it as a part of
its distribution or sale substantially differ from any claims made for
it as a part of the statement required in connection with its registra-
tion under section 3;
"(C) any registered pesticide the composition of which differs at
the time of its distribution or sale from its composition as described
in the statement required in connection with its registration under
section 3;
"(D) any pesticide which has not been colored or discolored pur- 7 use i36»
suant to the provisions of section 25(c)(5);
"(E) any pesticide which is adulterated or misbranded; or
"(F) any device which is misbranded.
"(2) It shall be unlawful for any person—
"(A) to detach, alter, deface, or destroy, in whole or in part, any
labeling required under this Act;
"(B) to refuse to keep any records required pursuant to section 8, 7 use ivsi,
or to refuse to allow the inspection of any records or establishment
pursuant to section 8 or 9, or to refuse to allow an officer or
employee of the Environmental Protection Agency to take a sample
of any pesticide pursuant to section 9;
"(C) to give a guaranty or undertaking provided for in subsection
(b) which is false in any particular, except that a person who receives
and relies upon a guaranty authorized under subsection (b) may give
a guaranty to the same effect, which guaranty shall contain, in addi-
tion to his own name and address, the name and address of the per-
son residing in the United States from whom he received the guaran-
ty or undertaking;
"(D) to use for his own advantage or to reveal, other than to the
Administrator, or officials or employees of the Environmental Pro-
tection Agency or other Federal executive agencies, or to the courts,
or to physicians, pharmacists, and other qualified persons, needing
such information for the performance of their duties, in accordance
with such directions as the Administrator may prescribe, any infor-
mation acquired by authority of this Act which is confidential under
this Act;
"(E) who is a registrant, wholesaler, dealer, retailer, or other 7 use n6a
distributor to advertise a produce registered under this Act for
restricted use without giving the classification of the product as-
signed to it under section 3;
"(F) to make available for use, or to use, any registered pesticide 7 use i36a
classified for restricted use for some or all purposes other than in ac-
cordance with section 3(d) and any regulations thereunder;
Provided, That it shall not be unlawful to sell, under regulations p i 95-396,
issued by the Administrator, a restricted use pesticide to a person 92 s'dl 832
who is not a certified applicator for application by a certified ap-
plicator;
"(G) to use any registered pesticide in a manner inconsistent with
its labeling;
"(H) to use any pesticide which is under an experimental use per-
mit contrary to the provisions of such permit;
"(I) to violate any order issued under section 13; 7 use H6k.
"(J) to violate any suspension order issued under section 6; 7 use HM
"(K) to violate any cancellation of registration of a pesticide
under section 6, except as provided by section 6(a)(l);
"(L) who is a producer to violate any of the provisions of section i use i36t
7;
25
-------
7 use 136e, i36i "(M) to knowingly falsify all or part of any application for
registration, application for experimental use permit, any informa-
tion submitted to the Administrator pursuant to section 7, any
records required to be maintained pursuant to section 8, any report
filed under this Act, or any information marked as confidential and
submitted to the Administrator under any provision of this act,
"(N) who is a registrant, wholesaler, dealer, retailer, or other
distributor to fail to file reports required by this Act;
"(O) to add any substance to, or take any substance from, any
pesticide in a manner that may defeat the purpose of this Act; or
"(P) to use any pesticide in tests on human beings unless such
human beings (i) are fully informed of the nature and purposes of the
test and of any physical and mental health consequences which are
reasonably foreseeable therefrom, and (ii) freely volunteer to par-
ticipate in the test.
"(b) Exemptions.—The penalties provided for a violation of paragraph (1)
of subsection (a) shall not apply to—
"(1) any person who establishes a guaranty signed by, and containing
the name and address of, the registrant or person residing in the United
States from whom he purchased or received in good faith the pesticide
in the same unbroken package, to the effect that the pesticide was
lawfully registered at the time of sale and delivery to him, and that it
complies with the other requirements of this Act, and in such case the
guarantor shall be subject to the penalties which would otherwise attach
to the person holding the guaranty under the provisions of this Act;
"(2) any carrier while lawfully shipping, transporting, or delivering
for shipment any pesticide or device, if such carrier upon request of any
officer or employee duly designated by the Administrator shall permit
such officer or employee to copy all of its records concerning such
pesticide or device;
"(3) any public official while engaged in the performance of his of-
ficial duties;
"(4) any person using or possessing any pesticide as provided by an
experimental use permit in effect with respect to such pesticide and such
use or possession; or
"(5) any person who ships a substance or mixture of substances being
put through tests in which the purpose is only to determine its value for
pesticide purposes or to determine its toxicity or other properties and
from which the user does not expect to receive any benefit in pest con-
trol from its use.
"SEC. 13. STOP SALE, USE, REMOVAL, AND SEIZURE.
"(a) Stop Sale, Etc., Orders.—Whenever any pesticide or device is found
by the Administrator in any State and there is reason to believe on the basis of
inspection or tests that such pesticide or device is in violation of any of the pro-
visions of this Act, or that such pesticide or device has been or is intended to
be distributed or sold in violation of any such provisions, or when the registra-
tion of the pesticide has been canceled by a final order or has been suspended,
the Administrator may issue a written or printed 'stop sale, use, or removal'
order to any person who owns, controls, or has custody of such pesticide or
device, and after receipt of such order no person shall sell, use, or remove the
pesticide or device described in the order except in accordance with the provi-
sions of the order.
"(b) Seizure.—Any pesticide or device that is being transported or, having
been transported, remains unsold or in original unbroken packages, or that is
sold or offered for sale in any State, or that is imported from a foreign coun-
try, shall be liable to be proceeded against in any district court in the district
26
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where it is found and seized for confiscation by a process in rem for condem-
nation if—
"(1) in the case of a pesticide—
"(A) it is adulterated or misbranded;
"(B) it is not registered pursuant to the provisions of section 3;
"(C) its labeling fails to bear the information required by this Act;
"(D) it is not colored or discolored and such coloring or discolor-
ing is required under this Act; or
"(E) any of the claims made for it or any of the directions for its
use differ in substance from the representations made in connection
with its registration;
"(2) in the case of a device, it is misbranded; or
"(3) in the case of a pesticide or device, when used in accordance
with the requirements imposed under this Act and as directed by the
labeling, it nevertheless causes unreasonable adverse effects on the en-
vironment. In the case of a plant regulator, defoliant, or desiccant, used
in accordance with the label claims and recommendations, physical or
physiological effects on plants or parts thereof shall not be deemed to be
injury when such effects are the purpose for which the plant regulator,
defoliant, or desiccant was applied.
"(c) Disposition After Condemnation.—If the pesticide or device is con-
demned it shall, after entry of the decree, be disposed of by destruction or sale
as the court may direct and the proceeds, if sold, less the court costs, shall be
paid into the Treasury of the United States, but the pesticide or device shall
not be sold contrary to the provisions of this Act or the laws of the jurisdiction
in which it is sold; Provided, That upon payment of the costs of the condem-
nation proceedings and the execution and delivery of a good and sufficient
bond conditioned that the pesticide or device shall not be sold or otherwise
disposed of contrary to the provisions of the Act or the laws of any jurisdic-
tion in which sold, the court may direct that such pesticide or device be
delivered to the owner thereof. The proceedings of such condemnation cases
shall conform, as near as may be to the proceedings in admiralty, except that
either party may demand trial by jury of any issue of fact joined in any case,
and all such proceedings shall be at the suit of and in the name of the United
States.
"(d) Court Costs, Etc.—When a decree of condemnation is entered against
the pesticide or device, court costs and fees, storage, and other proper ex-
penses shall be awarded against the person, if any, intervening as claimant of
the pesticide or device.
'SEC. 14. PENALTIES. ? use iw
"(a) Civil Penalties.—
"(I) In General.—Any registrant, commercial applicator, whole-
saler, dealer, retailer, or other distributor who violates any provision of
this Act may be assessed a civil penalty by the Administrator of not
more than $5,000 for each offense.
"(2) Private Applicator. — Any private applicator or other person not
included in paragraph (1) who violates any provision of this Act subse-
quent to receiving a written warning from the Administrator or follow-
ing a citation for a prior violation, may be assessed a civil penalty by the
Administrator of not more than $1,000 for each offense: Provided, PI 95-196.
That any applicator not included under paragraph (1) of this subsection 91 Sul H2
who holds or applies registered pesticides, or use dilutions of registered
pesticides, only to provide a service of controlling pests without deliver-
ing any unapplied pesticide to any person so served, and who violates
any provision of this Act may be assessed a civil penalty by the Ad-
ministrator of not more than $500 for the first offense nor more than
$1,000 for each subsequent offense.
27
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"(3) Hearing.—No civil penalty shall be assessed unless the person
charged shall have been given notice and opportunity for a hearing on
such charge in the county, parish, or incorporated city of the residence
of the person charged.
pi 95-396, "(4) Determination of Penalty.—In determining the amount of
92 Slal 8" the penalty, the Administrator shall consider the appropriateness of such
penalty to the size of the business of the person charged, the effect on
the person's ability to continue in business, and the gravity of the viola-
tion. Whenever the Administrator finds that the violation occurred
despite the exercise of due care or did not cause significant harm to
health or the environment, the Administrator may issue a warning in
lieu of assessing a penalty.".
"(5) References to Attorney General.—In case of inability to collect
such civil penalty or failure of any person to pay all, or such portion of
such civil penalty as the Administrator may determine, the Ad-
ministrator shall refer the matter to the Attorney General, who shall
recover such amount by action in the appropriate United States district
court.
"(b) Criminal Penalties.—
"(1) In General.—Any registrant, commercial applicator,
wholesaler, dealer, retailer, or other distributor who knowingly violates
any provision of this Act shall be guilty of a misdemeanor and shall on
conviction be fined not more than $25,000, or imprisoned for not more
than one year, or both.
"(2) Private applicator.—Any private applicator or other person not
included in paragraph (1) who knowingly violates any provision of this
Act shall be guilty of a misdemeanor and shall on conviction be fined
not more than $1,000, or imprisoned for not more than 30 days, or
both.
"(3) Disclosure of information.—Any person, who, with intent to
defraud, uses or reveals information relative to formulas of products ac-
7 use n6a quired under the authority of section 3, shall be fined not more than
$10,000, or imprisoned for not more than three years, or both.
"(4) Acts of officers, agents, etc.—When construing and enforcing
the provisions of this Act, the act, omission, or failure of any officer,
agent, or other person acting for or employed by any person shall in
every case be also deemed to be the act, omission, or failure of such per-
son as well as that of the person employed.
7 use i36m "SEC. 15. INDEMNITIES.
"(a) Requirement.—If—
"(1) the Administrator notifies a registrant that he has suspended the
registration of a pesticide because such action is necessary to prevent an
imminent hazard;
"(2) the registration of the pesticide is canceled as a result of a final
determination that the use of such pesticide will create an imminent
hazard; and
"(3) any person who owned any quantity of such pesticide im-
mediately before the notice to the registrant under paragraph (1) suf-
fered losses by reason of suspension or cancellation of the registration.
The Administrator shall make an indemnity payment to such person,
unless the Administrator finds that such person (i) had knowledge of
facts which, in themselves, would have shown that such pesticide did
7 LSC B6a not meet the requirements of section 3(c)(5) for registration, and (ii)
continued thereafter to produce such pesticide without giving timely
notice of such facts to the Administrator.
"(b) Amount of Payment.—
"(1) In General.—The amount of the indemnity payment under
28
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subsection (a) to any person shall be determined on the basis of the cost
of the pesticide owned by such person immediately before the notice to
the registrant referred to in subsection (a)(l); except that in no event
shall an indemnity payment to any person exceed the fair market value
of the pesticide owned by such person immediately before the notice
referred to in subsection (a)(l)-
"(2) Special rule.—Notwithstanding any other provision of his Act,
the Administrator may provide a reasonable time for use or other
disposal of such pesticide. In determining the quantity of any pesticide
for which indemnity shall be paid under this subsection, proper adjust-
ment shall be made for any pesticide used or otherwise disposed of by
such owner.
"SEC. 16. ADMINISTRATIVE PROCEDURE; JUDICIAL REVIEW. 7 use U6n
"(a) District Court Review.—Except as is otherwise provided in this Act,
Agency refusals to cancel or suspend registrations or change classifications not
following a hearing and other final Agency actions not committed to Agency
discretion by law are judicially reviewable in the district courts.
"(b) Review by Court of Appeals.—In the case of actual controversy as to
the validity of any order issued by the Administrator following a public hear-
ing, any person who will be adversely affected by such order and who had been
a party to the proceedings may obtain judicial review by filing in the United
States court of appeals for the circuit wherein such person resides or has a
place of business, within 60 days after the entry of such order, a petition pray-
ing that the order be set aside in whole or in part. A copy of the petition shall
be forthwith transmitted by the clerk of the court to the Administrator or any
officer designated by him for that purpose, and thereupon the Administrator
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 fil- 72 siai 941.
ing of such petition the court shall have exclusive jurisdiction to affirm or set sosiai 1323
aside the order complained of in whole or in part. The court shall consider all
evidence of record. The order ot the Administrator shall be sustained if
it is supported by substantial evidence when considered on the record as a
whole. 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 pro-
vided in section 1254 of title 28 of the United States Code. The commencement 52 sut 928
of proceedings under this section shall not, unless specifically ordered by the
court to the contrary, operate as a stay of an order. The court shall advance on
the docket and expedite the disposition of all cases filed therein pursuant to
this section.
"(c) Jurisdiction of District Courts.—The district courts of the United
States are vested with jurisdiction specifically to enforce, and to prevent and
restrain violations of this Act.
"(d) Notice of Judgments.—The Administrator shall, by publication in
such manner as he may prescribe, give notice of all judgments entered in ac-
tions instituted under the authority of this Act.
"SEC. 17. IMPORTS AND EXPORTS.
"(a) Pesticides and Devices Intended for Export.—Notwithstanding any PI 95-3%,
92 Slat 833
(Sec nolc below)
other provision of this Act, no pesticide or device or active ingredient used in 92 Sul 813
Section 18 (b) of the Federal Pesticide Act of 1978 provides, The amendment [lo Section 17(a)l
made by subsection (a)(l) of this section shall become effective March 29, 1979
29
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producing a pesticide intended solely for export to any foreign country shall be
deemed in violation of this Act—
"(1) when prepared or packed according to the specifications or
directions of the foreign purchaser, except that producers of such
pesticides and devices and active ingredients used in producing
7 use 136, i36e, n6r pesticides shall be subject to sections 2(p), 2(q)(l) (A), (C), (D), (E),
(G), and (H), 2(q)(2) (A), (B), (C) (i) and (iii), and (D), 7, and 8 of this
Act; and
"(2) in the case of any pesticide other than a pesticide registered
7 use i36a, i36d under section 3 or sold under section 6(a)(l) of this Act, if, prior to ex-
port, the foreign purchaser has signed a statement acknowledging that
the purchaser understands that such pesticide is not registered for use in
the United States and cannot be sold in the United States under this Act.
A copy of that statement shall be transmitted to an appropriate official
of the government of the importing country.
"(b) Cancellation Notices Furnished to Foreign Governments.—Whenever
a registration, or a cancellation or suspension of the registration of a pesticide
becomes effective, or ceases to be effective, the Administrator shall transmit
through the State Department notification thereof to the governments of other
p L 95-396, countries and to appropriate international agencies. Such notification shall,
92 ilal 833 upon request, include all information related to the cancellation or suspension
of the registration of the pesticide and information concerning other pesticides
Notification that are registered under section 3 of this Act and that could be used in lieu of
such pesticide.
"(c) Importation of Pesticides and Devices.—The Secretary of the
Treasury shall notify the Administrator of the arrival of pesticides and devices
and shall deliver to the Administrator, upon his request, samples of pesticides
or devices which are being imported into the United States, giving notice to the
owner or consignee, who may appear before the Administrator and have the
right to introduce testimony. If it appears from the examination of a sample
that it is adulterated, or misbranded or otherwise violates the provisions set
forth in this Act, or is otherwise injurious to health or the environmenl, the
pesticide or device may be refused admission, and the Secretary of the
Treasury shall refuse delivery to the consignee and shall cause the destruction
of any pesticide or device refused delivery which shall not be exported by the
consignee within 90 days from the date of notice of such refusal under such
regulations as the Secretary of Treasury may prescribe: Provided, That the
Secretary of the Treasury may deliver to the consignee such pesticide or device
pending examination and decision in the matter on execution of bond for the
amount of the full invoice value of such pesticide or device, together with the
duty thereon, and on refusal to return such pesticide or device for any cause to
the custody of the Secretary of the Treasury, when demanded, for the purpose
of excluding them from the country, or for any other purpose, said consignee
shall forfeit the full amount of said bond: And provided further, That all
charges for storage, cartage, and labor on pesticides or devices which are
refused admission or delivery shall be paid by the owner or consignee, and in
default of such payment shall constitute a lien against any future importation
made by such owner or consignee.
"(d) Cooperation in International Efforts.—The Administrator shall in
cooperation with the Department of State and any other appropriate Federal
agency, participate and cooperate in any international efforts to develop im-
proved pesticide research and regulations.
"(e) Regulations.—The Secretary of the Treasury, in consultation with the
Administrator, shall prescribe regulations for the enforcement of subsection
(c) of this section.
i use i36P "SEC. 18. EXEMPTION OF FEDERAL AGENCIES.
"The Administrator may, at his discretion, exempt any Federal or State
30
-------
agency from any provision of this Act if he determines that emergency condi-
tions exist which require such exemption.
"The Administrator, in determining whether or not such emergency condi- P i 94-140,
tions exist, shall consult with the Secretary of Agriculture and the Governor of 89 S|JI 754
any State concerned if they request such determination."
"SEC. 19. DISPOSAL AND TRANSPORTATION.
"(a) Procedures.—The Administrator shall, after consultation with other
interested Federal agencies, establish procedures and regulations for the
disposal or storage of packages and containers of pesticides and for disposal
or storage of excess amounts of such pesticides, and accept at convenient loca-
tions for safe disposal a pesticide the registration of which is canceled under
section 6(c) if requested by the owner of the pesticide.
"(b) Advice to Secretary of Transportation.—The Administrator shall pro-
vide advice and assistance to the Secretary of Transportation with respect to
his functions relating to the transportation of hazardous materials under the
Department of Transportation Act (49 U.S.C. 1657), the Transportation of
Explosives Act (18 U.S.C. 831-835), the Federal Aviation Act of 1958 (49
U.S.C. 1421-1430, 1472 II), and the Hazardous Cargo Act (46 U.S.C. 170,
375, 416).
"(c) Provisions for unused quantities.—Notification of cancellation of any
pesticide shall include specific provisions for the disposal of the unused quan-
tities of such pesticide.
7 HSC U6i|
8(1 Sid 944,
74 Sid 808,
79 Sid 286,
72 .Sid
85 Sid
C omrdLl
AmhoiilN
P L 95 396,
92 Sldt 833
"SEC. 20. RESEARCH AND MONITORING.
"(a) Research.—The Administrator shall undertake research, including
research by grant or contract with other Federal agencies, universities, or
others as may be necessary to carry out the purposes of this Act, and he shall
conduct research into integrated pest management in coordination with the
Secretary of Agriculture. The Administrator shall also take care to insure that
such research does not duplicate research being undertaken by any other
Federal agency.
"(b) National Monitoring Plan.—The Administrator shall formulate and
periodically revise, in cooperation with other Federal, State, or local agencies,
a national plan for monitoring pesticides.
"(c) Monitoring.—The Administrator shall undertake such monitoring ac-
tivities, including, but not limited to, monitoring in air, soil, water, man,
plants, and animals, as may be necessary for the implementation of this Act
and of the national pesticide monitoring plan. The Administrator shall
establish procedures for the monitoring of man and animals and their environ-
ment for incidental pesticide exposure, including, but not limited to, the quan-
tification of incidental human and environmental pesticide pollution and the
secular trends thereof, and identification of the sources of contamination and
their relationship to human and environmental effects. Such activities shall be
carried out in cooperation with other Federal, State, and local agencies.
P I 95-396,
92 Sldt 834
P 1 95-396,
92 Slat 834
"SEC. 21. SOLICITATION OF COMMENTS; NOTICE OE PUBLIC 7tsci3^
HEARINGS.
"(a) The Administrator, before publishing regulations under this Act, shall PI 94140.
solicit the views of the Secretary of Agriculture in accordance with the pro- 89 Su" 752>
cedure described in section 25(a). 7 use n<™
"(b) In addition to any other authority relating to public hearings and
31
-------
Publications in
Federal Register
solicitation of views, in connection with the suspension or cancellation of a
pesticide registration or any other actions authorized under this Act, the Ad-
ministrator may, at his discretion, solicit the views of all interested persons,
either orally or in writing, and seek such advice from scientists, farmers, farm
organizations, and other qualified persons as he deems proper.
"(c) In connection with all public hearings under this Act the Ad-
ministrator shall publish timely notice of such hearings in the Federal Register.
"SEC. 22. DELEGATION AND COOPERATION.
"(a) Delegation.—All authority vested in the Administrator by virtue of the
provisions of this Act may with like force and effect be executed by such
employees of the Environmental Protection Agency as the Administrator may
designate for the purpose.
"(b) Cooperation.—The Administrator shall cooperate with the Depart-
ment of Agriculture, any other Federal agency, and any appropriate agency of
any State or any political subdivision thereof, in carrying out the provisions of
this Act, and in securing uniformity of regulations.
P L 95-396,
92 Slat 834
"SEC. 23. STATE COOPERATION, AID, AND TRAINING.
"(a) Cooperative Agreements.—The Administrator may enter into
cooperative agreements with States and Indian tribes—
"(1) to delegate to any State or Indian tribe the authority to
cooperate in the enforcement of this Act through the use of its personnel
or facilities, to train personnel of the State or Indian tribe to cooperate
in the enforcement of this Act, and to assist States and Indian tribes in
implementing cooperative enforcement programs through grants-iri-aid;
and
"(2) to assist States in developing and administering State programs,
and Indian tribes that enter into cooperative agreements, to train and
certify applicators consistent with the standards the Administrator
prescribes.
Effective with the fiscal year beginning October 1, 1978, there are author-
ized to be appropriated annually such funds as may be necessary for the Ad-
ministrator to provide through cooperative agreements an amount equal to 50
percent of the anticipated cost to each State or Indian tribe, as agreed to under
such cooperative agreements, of conducting training and certification pro-
grams during such fiscal year. If funds sufficient to pay 50 percent of the costs
for any year are not appropriated, the share of each State and Indian tribe
shall be reduced in a like proportion in allocating available funds.
"(b) Contracts for Training.—In addition, the Administrator may enter in-
to contracts with Federal, State, or Indian tribal agencies for the purpose of
encouraging the training of certified applicators.
"(c) Information and Education.—The Administrator shall, in coopera-
tion with the Secretary of Agriculture, use the services of the cooperative State
extension services to inform and educate pesticide users about accepted, uses
and other regulations made under this Act.
^ USC 136v
P L 95-396.
92 Slat 835
"SEC. 24. AUTHORITY OF STATES.
"(a) A State may regulate the sale or use of any federally registered
pesticide or device in the State, but only if and to the extent the regulation does
not permit any sale or use prohibited by this Act.
32
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"(b) Such State shall not impose or continue in effect any requirements for
labeling or packaging in addition to or different from those required under
this Act.
"(c)(l) A State may provide registration for additional uses of federally
registered pesticides formulated for distribution and use within that
State to meet special local needs in accord with the purposes of this Act
and if registration for such use has not previously been denied, disap-
proved, or cancelled by the Administrator. Such registration shall be
deemed registration under section 3 for all purposes of this Act, but
shall authorize distribution and use only within such State.
"(2) A registration issued by a State under this subsection shall not
be effective for more than ninety days if disapproved by the Ad-
ministrator within that period. Prior to disapproval, the Administrator
shall, except as provided in paragraph (3) of this subsection, advise the
State of the Administrator's intention to disapprove and the reasons
therefor, and provide the State time to respond. The Administrator shall
not prohibit or disapprove a registration issued by a State under this
subsection (A) on the basis of lack of essentiality of a pesticide or (B) ex-
cept as provided in paragraph (3) of this subsection, if its composition
and use patterns are similar to those of a federally registered pesticide.
"(3) In no instance may a State issue a registration for a food or feed
use unless there exists a tolerance or exemption under the Federal Food,
Drug, and Cosmetic Act that permits the residues of the pesticide on the
food or feed. If the Administrator determines that a registration issued
by a State is inconsistent with the Federal Food, Drug, and Cosmetic
Act, or the use of a pesticide under a registration issued by a State con-
stitutes an imminent hazard, the Administrator may immediately disap-
prove the registration.
"(4) If the Administrator finds, in accordance with standards set
forth in regulations issued under section 25 of this Act, that a State is
not capable of exercising adequate controls to assure that State registra-
tion under this station will be in accord with the purposes of this act or
has failed to exercise adequate controls, the Administrator may suspend
the authority of the State to register pesticides until such time as the Ad-
ministrator is satisfied that the State can and will exercise adequate con-
trols. Prior to any such suspension, the Administrator shall advise the
State of the Administrator's intention to suspend and the reasons
therefor and provide the State time to respond.".
'SEC. 25. AUTHORITY OF ADMINISTRATOR.
"(a)(l) Regulations.—The Administrator is authorized in accordance with
the procedure described in paragraph (2), to prescribe regulations to
carry out the provisions of this Act. Such regulations shall take into ac-
count the difference in concept and usage between various classes of
pesticides and differences in environmental risk and the appropriate data
for evaluating such risk between agricultural and nonagricultural
pesticides.
(2) Procedure.—
"(A) Proposed regulations.—At least 60 days prior to signing any
proposed regulation for publication in the Federal Register, the Ad-
ministrator shall provide the Secretary of Agriculture with a copy of
such regulation. If the Secretary comments in writing to the Ad-
ministrator regarding any such regulation within 30 days after receiv-
ing it, the Administrator shall publish in the Federal Register (with
the proposed regulation) the comments of the Secretary and the
response of the Administrator with regard to the Secretary's com-
ments. If the Secretary does not comment in writing to the Ad-
P 1 94-140,
89 Stat 751
P I 94-140,
89 Slat 752
Publications in
Federal Rcgiste
P I 95-196.
92 Stal 836
33
-------
ministrator regarding the regulation within 30 days after receiving it,
the Administrator may sign such regulation for publication in the
Federal Register any time after such 30-day period notwithstanding
the foregoing 60-day time requirement.
"(B) Final regulations.—At least 30 days prior to signing any
regulation in final form for publication in the Federal Register, the
publication m Administrator shall provide the Secretary of Agriculture with a copy
Federal Register Qf such regu[atjon if the Secretary comments in writing to the Ad-
ministrator regarding any such final regulation within 15 days after
receiving it, the Administrator shall publish in the Federal Register
(with the final regulation) the comments of the Secretary, if re-
quested by the Secretary, and the response of the Administrator con-
cerning the Secretary's comments. If the Secretary does not comment
in writing to the Administrator regarding the regulation within 15
days after receiving it, the Administrator may sign such regulation
for publication in the Federal Register at any time after such 15-day
period notwithstanding the foregoing 30-day time requirement.
p L 95 396, In taking any final action under this subsection, the Administrator
92 stai 836 shall include among those factors to be taken into account the effect
of the regulation on production and prices of agricultural com-
modities, retail food prices, and otherwise on the agriculiural
publication m economy, and the Administrator shall publish in the Federal Register
federal Register an analysis of such effect.
"(C) Time requirements.—The time requirements imposed by
subparagraphs (A) and (B) may be waived or modified to the extent
agreed upon by the Administrator and the Secretary.
"(D) Publication in the federal register.—The Administrator
shall, simultaneously with any notification to the Secretary of
Agriculture under this paragraph prior to the issuance of any pro-
posed or final regulation, publish such notification in the Federal
Register.".
P i 94-i4o. "(3) Congressional Committees.—At such time as the Administrator
89 Stal 753 is required under paragraph (2) of this subsection to provide the
Secretary of Agriculture with a copy of proposed regulations and a copy
of the final form of regulations, he shall also furnish a copy of such
regulations to the Committee on Agriculture of the House of Represen-
tatives and the Committee on Agriculture and Forestry of the Senate."
"(b) Exemption of Pesticides.—The Administrator may exempt from the
requirements of this Act by regulation any pesticide which he determines either
(1) to be adequately regulated by another Federal agency, or (2) to be of a
character which is unnecessary to be subject to this Act in order to carry out
the purposes of this Act.
"(c) Other Authority.— The Administrator, after notice and opportunity
for hearing, is authorized—
"(1) to declare a pest any form of plant or animal life (other than
man and other than bacteria, virus, and other micro-organisms on or in
living man or other living animals) which is injurious to health or the en-
vironment:
"(2) to determine any pesticide which contains any substance or
substances in quantities highly toxic to man;
"(3) to establish standards (which shall be consistent with those
84 stat 1670 established under the authority of the Poison Prevention Packaging Act
15 use 1471 note (Public Law 91-601)) with respect to the package, container, or wrap-
ping in which a pesticide or device is enclosed for use or consumption, in
order to protect children and adults from serious injury or illness
resulting from accidental ingestion or contact with pesticides or devices
regulated by this Act as well as to accomplish the other purposes of this
Act;
"(4) to specify those classes of devices which shall be subject to any
7 use i36e provision of paragraph 2(q)(l) or section 7 of this Act upon his deter-
34
-------
mination that application of such provision is necessary to effectuate the
purposes of this Act;
"(5) to prescribe regulations requiring any pesticide to be colored or
discolored if he determines that such requirement is feasible and is
necessary for the protection of health and the environment; and
"(6) to determine and establish suitable names to be used in the in-
gredient statement.
"(d) Scientific Advisory Panel.—The Administrator shall submit to an ad- p L 94-140,
visory panel for comment as to the impact on health and the environment of 89Slal 753
the action proposed in notices of intent issued under section 6(b) and of the 7 use i36d
proposed and final form of regulations issued under section 25(a) within the 7 use i.v™
same time periods as provided for the comments of the Secretary of
Agriculture under such sections. The time requirements for notices of intent
and proposed and final forms of regulation may not be modified or waived
unless in addition to meeting the requirements of section 6(b) or 25(a), as ap-
plicable, the advisory panel has failed to comment on the proposed action
within the prescribed time period or has agreed to the modification or waiver.
The Administrator shall also solicit from the advisory panel comments, p i 95-*»,
evaluations, and recommendations for operating guidelines to improve the ef- 92Slal 8-16
fectiveness and quality of scientific analyses made by personnel of the En-
vironmental Protection Agency that lead to decisions by the Administrator in
carrying out the provisions of this Act. The comments, evaluations, and Pubinanon m
recommendations of the advisory panel and the response of the Administrator 'cdcwl Re8lslCT
shall be published in the Federal Register in the same manner as provided for
publication of the comments of the Secretary of Agriculture under such sec-
tions. The Chairman of the advisory panel, after consultation with the Ad-
ministrator, may create temporary subpanels on specific projects to assist the
full advisory panel in expediting and preparing its evaluations, comments, and
recommendations. The panel referred to in this subsection shall consist of Members
seven members appointed by the Administrator from a list of 12 nominees, six
nominated by the National Institutes of Health, and six by the National
Science Foundation. The Administrator may require such information from pubinanon m
the nominees to the advisory panel as he deems necessary, and he shall publish fedcral Register
in the Federal Register the name, address, and professional affiliations of each
nominee. Each member of the panel shall receive per diem compensation at a compensation
rate not in excess of that fixed for GS-18 of the General Schedule as may be - ust s"2 n"K
determined by the Administrator, except that any such member who holds
another office or position under the Federal Government the compensation p i 94 HO,
for which exceeds such rate may elect to receive compensation at the rate pro- 89 Su" ™
vided for such other office or position in lieu of the compensation provided by
this subsection. In order to assure the objectivity of the advisory panel, the Regulations
Administrator shall promulgate regulations regarding conflicts of interest with
respect to the members of the panel. The advisory panel established under this PI 95 -vx,. 92 siat 836
subsection shall terminate September 30, 1981. In performing the functions AIMSOI> panel,
assigned by this Act, the panel shall consult and coordinate its activities with rcmi"M"u"
the Science Advisory Board established under the Environmental Research, 42 ust 4365
Development, and Demonstration Authorization Act of 1978.
"SEC. 26. STATE PRIMARY ENFORCEMENT RESPONSIBILITY. 7 use IM»-
"(a) For the purposes of this Act, a State shall have primary enforcement p i 95-396,
responsibility for pesticide use violations during any period for which the Ad- 92 Sul 836
ministrator determines that such State—
"(1) has adopted adequate pesticide use laws and regulations; Pro-
vided, That the Administrator may not require a State to have pesticide
use laws that are more stringent than this Act;
"(2) has adopted and is implementing adequate procedures for the
enforcement of such State laws and regulations; and
35
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7 USC 136
7 USC 136f
7 USC 136g
"(3) will keep such records and make such reports showing com-
pliance with paragraphs (1) and (2) of this subsection as the Ad-
ministrator may require by regulation.
"(b) Notwithstanding the provisions of subsection (a) of this section, any
State that enters into a cooperative agreement with the Administrator under
section 23 of this Act for the enforcement of pesticide use restrictions shall
have the primary enforcement responsibility for pesticide use violations. Any
State that has a plan approved by the Administrator in accordance with the re-
quirements of section 4 of this Act that the Administrator determines meets
the criteria set out in subsection (a) of this section shall have the primary en-
forcement responsibility for pesticide use violations. The Administrator shall
make such determinations with respect to State plans under Section 4 of this
Act in effect on September 30, 1978 not later than March 31, 1979
"(c) the Administrator shall have primary enforcement responsibility for
those States that do not have primary enforcement responsibility under this
Act. Notwithstanding the provisions of section 2(e) (1) of this Act, during any
period when the Administrator has such enforcement responsibility, section
8(b) of this Act shall apply to the books and records of commercial applicators
and to any applicator who holds or applies pesticides, or use dilutions of
pesticides, only to provide a service of controlling pests without delivering any
unapplied pesticide to any person so served, and section 9(a) of this Act shall
apply to the establishment or other place where pesticides or devices are held
for application by such persons with respect to pesticides or devices held for
such application.
P L 95-196,
92 Stal 837
7 USC 136»-1
"SEC. 27. FAILURE BY THE STATE TO ASSURE ENFORCEMENT OF
STATE PESTICIDE USE REGULATIONS.
"(a) Upon receipt of any complaint or other information alleging or in-
dicating a significant violation of the pesticide use provisions of this Act, the
Administrator shall refer the matter to the appropriate State officials for their
investigation of the matter consistent with the requirements of this Act. If,
within thirty days, the State has not commenced appropriate enforcement ac-
tion, the Administrator may act upon the complaint or information to the ex-
tent authorized under this Act.
"(b) Whenever the Administrator determines that a State having primary
enforcement responsibility for pesticide use violations is not carrying out (or
cannot carry out due to the lack of adequate legal authority) such responsibili-
ty, the Administrator shall notify the State. Such notice shall specify those
aspects of the administration of the State program that are determined to be
inadequate. The State shall have ninety days after receipt of the notice to cor-
rect any deficiencies. If after that time the Administrator determines that the
State program remains inadequate, the Administrator may rescind, in whole
or in part, the State's primary enforcement responsibility for pesticide use
violations.
"(c) Neither section 26 of this Act nor this section shall limit the authority
of the Administrator to enforce this Act, where the Adminstrator determines
that emergency conditions exist that require immediate action on the part of
the Administrator and the State authority is unwilling or unable adequately to
respond to the emergency.
7 USC U(j»-3
P I 95-396.
92 Slal 838
"SEC. 28. IDENTIFICATION OF PESTS; COOPERATION WITH
DEPARTMENT OF AGRICULTURE'S PROGRAM.
"The Administrator, in coordination with the Secretary of Agriculture,
shall identify those pests that must be brought under control. The Ad-
ministrator shall also coordinate and cooperate with the Secretary of
36
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Agriculture's research and implementation programs to develop and improve
the safe use and effectiveness of chemical, biological, and alternative methods
to combat and control pests that reduce the quality and economical produc-
tion and distribution of agricultural products to domestic and foreign con-
"SEC. 29. ANNUAL REPORT.
"The Administrator shall submit an annual report to Congress before
February 16 of each year and the first report shall be due February 15, 1979.
The report shall include the total number of applications for conditional
registration under section 3(c)(7)(B) and 3(c)(7)(C) of this Act that were filed
during the immediately preceding fiscal year, and, with respect to those ap-
plications approved, the Administrator shall report the Administrator's find-
ings in each case, the conditions imposed and any modification of such condi-
tions in each case, and the quantities produced of such pesticides.
7 USC 136»-4
P I. 95-396,
92 but 838
"SEC. 30. SEVERABILITY.
"If any provision of this Act or the application thereof to any person or cir-
cumstance is held invalid, the invalidity shall not affect other provisions or ap-
plications of this Act which can be given effect without regard to the invalid
provision or application, and to this end the provisions of this Act are
severable.
"SEC. 31. AUTHORIZATION FOR APPROPRIATIONS.
"There is authorized to be appropriated such sums as may be necessary to
carry out the provisions of this Act for each of the fiscal years ending June 30,
1973, June 30, 1974, and June 30, 1975. The amounts authorized to be ap-
propriated for'any fiscal year ending after June 30, 1975, shall be the sums
hereafter provided by law."
"There are hereby authorized to be appropriated to carry out the provisions
of this Act for the period beginning October 1, 1975, and ending September
30, 1976, the sum of $47,868,000 and for the period beginning October 1,
1976, and ending September 30, 1977, the sum of $46,636,000, and for the
period beginning October 1, 1977, and ending September 30, 1978, the sum of
$54,500,000, and for the period beginning October 1, 1978, and ending
September 30, 1979, such sums as may be necessary, but not in excess of
$70,000,000".
7 LS( I36y
P L 94-140,
89 Slal 752
P L 95-396,
92 Slal 838
Amendments to Other Acts
Sec. 3. of P.L. 92-516 (1972) states, 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:
(1) The Federal Hazardous Substances Act, as amended (15 U.S.C. 74Siai nos
1261 et seq.);
(2) The Poison Prevention Packaging Act, as amended (15 U.S.C. 84 siai i67o
1471 et seq.); and
(3) The Federal Food, Drug, and Cosmetic Act, as amended (21 52Sid[ 1040
U.S.C. 301 et seq.).
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Savings
provision
61 Stat 163
7 USC 135 note
P L 94-140,
89 Slat 752
P L 94-140,
89 Stat 753
P L 95-396,
92 Stat 842
Effective Dates of Provisions of Act
Sec. 4. of P.L. 92-516 (1972), as amended, states, (a) Except as otherwise
provided in the Federal Insecticide, Fungicide, and Rodenticide Act, as
amended by this Act, and as otherwise provided by this section, the amend-
ments made by this Act shall take effect at the close of the date of the enact-
ment of this Act, provided if regulations are necessary for the implementation
of any provision that becomes effective on the date of enactment, such regu-
lations shall be promulgated and shall become effective within 90 days from
the date of enactment of this Act.
(b) The provisions of the Federal Insecticide, Fungicide, and Rodenticide
Act and the regulations thereunder as such existed prior to the enactment of
this Act shall remain in effect until superseded by the amendments made by
this Act and regulations thereunder.
(c)(l) Two years after the enactment of this Act the Administrator shall
have promulgated regulations providing for the registration and
classification of pesticides under the provisions of this Act and
thereafter shall register all new applications under such provisions.
(2) Any requirements that a pesticide be registered for use only by a
certified applicator shall not be effective until five years from the date of
enactment of this Act.
(3) A period of five years from date of enactment shall be provided
for certification of applicators.
(A) One year after the enactment of this Act the Administrator
shall have prescribed the standards for the certification of ap-
plicators.
(B) Each State desiring to certify applicators shall submit a State
plan to the Adminstrator for the purpose provided by section 4(b).
(C) As promptly as possible but in no event more than one year
after submission of a State plan, the Administrator shall approve the
State plan or disapprove it and indicate the reasons for disapproval.
Consideration of plans resubmitted by States shall be expedited.
(4) One year after the enactment of this Act the Administrator shall
have promulgated and shall make effective regulations relating to the
registration of establishments, permits for experimental use, and the
keeping of books and records under the provisions of this Act.
(d) No person shall be subject to any criminal or civil penalty imposed by
the Federal Insecticide, Fungicide, and Rodenticide Act, as amended by this
Act, for any act (or failure to act) occurring before the expiration of 60 days
after the Administrator has published effective regulations in the Federal
Register and taken such other action as may be necessary to permit compliance
with the provisions under which the penalty is to be imposed.
(e) For purposes of determining any criminal or civil penalty or liability to
any third person in respect of any act or omission occurring before the expira-
tion of the periods referred to in this section, the Federal Insecticide,
Fungicide, and Rodenticide Act shall be treated as continuing in effect as if
this Act had not been enacted.
Legislative History
Public Law 92-516
92nd Congress, H. R. 10729
Occober 21, 1972
HOUSE REPORTS: No. 92-511 (Comm. on Agriculture) and No. 92-1540 (Comm. of
Conference).
SENATE REPORTS: No. 92-838 (Comm. on Agriculture and Forestry) and No. 92-
970 (Comm. on Commerce).
38
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CONGRESSIONAL RECORD:
Vol. 117 (1971): Nov. 8, 9, considered and passed House.
Vol. 118 (1972): Sept. 26, considered and passed Senate, amended.
Oct. 5, Senate agreed to conference report.
Oct. 12, House agreed to conference report.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS:
Vol. 8, No. 44 (1972): Oct. 21, Presidential statement.
Public Law 94-14D
94lh Congress, H. R. 8841
November 28, 1975
HOUSE REPORTS: No. 94-497 (Comm. on Agriculture) and NO. 94-668 (Comm.
of Conference).
SENATE REPORT No. 94-452 (Comm. on Agriculture and Forestry).
CONGRESSIONAL RECORD: Vol. 121 (1975)
Sept. 26, Oct. 3, 9, considered and passed House.
Nov. 12, considered and passed Senate, amended.
Nov. 18, House agreed to conference report.
Nov. 19, Senate agreed to conference report.
Public Law 95—396
951h Congress, S. 1678
September 30, 1978
HOUSE REPORTS: No. 95-343 and No. 95-343, Pt. 2, (Comm. on Agriculture) both
accompanying H.R. 7073 and No. 95-1560 (Comm. of Con-
ference).
SENATE REPORTS: No. 95-334 (Comm. on Agriculture, Nutrition and Forestry) and
95-1188 (Comm. of Conference).
CONGRESSIONAL RECORD:
Vol. 123 (1977): July 29, considered and passed Senate.
Sept. 22, Oct 31, considered and passed House, amended, in lieu of
H.R. 7073.
Vol. 124 (1978): Sept. 18, Senate agreed to conference report.
Sept. 19, House agreed to conference report.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS.
Vol. 14, No. 40: Oct. 2, 1978, Presidential statement.
The following is Section 27(a) of P.L. 95-396, the "Federal Pesticide Act of 1978",
but is not an amendment to FIFRA.
Studies
Sec. 27. (a) The Administrator of the Environmental Protection Agency 7 use i36
shall perform a study examining the feasibility of assessing and collecting fees notc
from persons applying to register, or amend the registration of, pesticides to
cover the costs incurred by the Environmental Protection Agency in process-
ing such applications under the provisions of the Federal Insecticide,
Fungicide, and Rodenticide Act. The Administrator shall complete this study Repon \o
and submit a report setting forth the findings of the study and recommenda- Congression
tions for the implementation of these findings to the Senate. Committee on
Agriculture, Nutrition, and Forestry and the House Committee on
Agriculture, not later than June 30, 1979.
(b) The Adminstrator, in cooperation with the Secretary of Agriculture,
and after consultation with appropriate State officials, shall review available
scientific information dealing with issues involved in the methods of pesticide
application, including , but not limited to, the advisability of ultra-Iow-volume
methods of application, and shall recommend to the Senate Committee on
39
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Agriculture, Nutrition, and Forestry and the House Committee on Agriculture
such changes as the Administrator may deem necessary in existing law relative
to provisions of the Act pertaining to the use of a registered pesticide in a
manner inconsistent with its labeling. The report shall be submitted as soon
as practicable, but not later than March 31, 1979.
(c) The Administrator shall submit an updated study examining the prob-
lems of minor uses of pesticides not specifically permitted by labeling. The Ad-
ministrator shall complete this study and submit a report setting forth the find-
ings of the study and recommendations for the implementation of these find-
ings to the Senate Committee on Agriculture, Nutrition, and Forestry and the
House Committee on Agriculture, not later than June 30, 1979
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U.S. Environmental Protection Agency
Region 5, Library (PL- 12J)
77 West Jackson Boulevard. 12tti
Chicago. !L 60604-3590
-------
If you have suggestions,
questions, or requests for
further information, they
may be directed to your
nearest EPA Regional public
information office.
EPA Region 1 • JFK
Federal Bldg • Boston
MA 02203 • Connec
ticut, Maine, Massachu-
setts, New Hampshire,
Rhode Island, Vermont •
617-223-7210
EPA Region 2 • 26
Federal Plaza • New
York NY 10007 • New
Jersey, New York, Puer-
to Rico, Virgin Islands •
212-264-2525
EPA Region 3 • 6th
and Walnut Streets •
Philadelphia PA 19106
• Delaware, Maryland,
Pennsylvania, Virginia,
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Columbia • 215-597 9814
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Courtland Street NE •
Atlanta GA 30308 •
Alabama, Georgia,
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Carolina, Tennessee,
Kentucky • 404-881 4727
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Dearborn • Chicago IL
60604 • Illinois, Indiana,
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sin, Minnesota •
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siana, Oklahoma, Texas,
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orado, Utah, Wyoming,
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Fremont Street • San
Francisco CA 94105 •
Arizona, California,
Nevada, Hawaii, Guam,
American Samoa, Trust
Territories of the Pacific
• 415-556-2320
EPA Region 10 • 1200 ' /
Sixth Avenue • Seattle
WA 98101 • Alaska,
Idaho, Oregon, Washing
ton • 206 442-1220
EPA is charged by Congress to protect the Nation's land, air and water
systems. Under a mandate of national environmental laws focused on air
and water quality, solid waste management and the control of toxic
substances, pesticides, noise and radiation, the Agency strives to for-
mulate and implement actions which lead to a compatible balance be-
tween human activities and the ability of natural systems to support and
nurture life.
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