LvEPA
United States
Environmental Protection
Agency
540/09-89-012
Revised October 1988
Office of Pesticide Programs
The Federal
Insecticide, Fungicide,
and Rodenticide Act
as Amended
Printed on Recycled Paper
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FEDERAL INSECTICIDE, FUNGICIDE, AND
RODENTICIDE ACT
(THROUGH P.L. 100-460,100-464 to 100-526, & 100-532)
(References [ ] in brackets are to title 7, United States Code)
TABLE OF CONTENTS
U.S.C. Act Sec. Page
7 U.S.C.
prec. 121 1. Short title and table of contents 3
136 2. Definitions 7
136a 3. Registration of pesticides 13
136b 4. Reregistration of pesticides 22
136c 5. Experimental use permits 33
136d 6. Administrative review; suspension 34
136e 7i Registration of establishments 39
136f 8. Books and records , 39
136g 9. Inspection of establishments, etc 40
136h 10. Protection of trade secrets and other infer- 41
mation.
136i 11. Use of restricted use pesticides; appplica- 44
tors.
136j 12. Unlawful acts 45
136k 13. Stop sale, use, removal, and seizure 48
1361 14. Penalties 49
136m 15. Indemnities 50
136n 16. Administrative procedure; judicial review 52
136o 17. Imports and exports 53
136p 18. Exemption of Federal and State agencies 54
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TABLE OF CONTENTS—Continued
136q 19. Disposal and transportation 54
136r 20. Research and monitoring 58
136s 21. Solicitation of comments; notice of public 59
hearings.
136t 22. Delegation and cooperation 59
186u 23. State cooperation, aid, and training 59
136v 24. Authority of States 60
136w 25. Authority of Administrator 60
186w-l 26. State primary enforcement responsibility 64
136w-2 27. Failure by the State to assure enforcement 65
of State pesticide use regulations.
136w-3 28. Identification of pests; cooperation with De- 65
partment of Agriculture's program.
136w-4 29. Annual report 65
136x 30. Severability 65
136y 31. Authorization for appropriations 65
Bracketed material and footnotes did not appear in Acts.
Prepared by the Senate Legislative Counsel's Office.
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Sec. 1
Act of June 25, 1947
Chapter 125
AN ACT
To regulate the marketing of economic poisons and devices, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. [prec. 121] SHORT TITLE AND TABLE OF CONTENTS.
(a) SHORT TITLE.—This Act may be cited as the "Federal Insecti-
cide, 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. Definitions.
(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.
(j) Environment.
(k) Fungus.
(1) Imminent hazard.
(m) Inert ingredient.
(n) Ingredient statement.
(o) Insect.
(p) Label and labeling.
(1) Label.
(2) Labeling.
(q) Misbranded.
(r) Nematode.
(s) Person.
(t) Pest.
(u) Pesticide.
(v) Plant regulator.
(w) Producer and produce.
(x) Protect health and the environment.
(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.
(ff) Outstanding data requirement.
(gg) To distribute or sell.
Sec. 3. Registration of pesticides.
(a) Requirement of registration.
(b) Exemptions.
(c) Procedure for registration.
(1) Statement required.
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(2) Data in support of registration.
(3) Time for acting with respect to application.
(4) Notice of application.
(5) Approval of registration.
(6) Denial of registration.
(7) Registration under special circumstances.
(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 other Federal agencies.
Sec. 4. Reregistration of registered pesticides.
(a) General rule.
(b) Reregistration phases.
(c) Phase one.
(1) Priority for reregistration.
(2) Reregistration lists.
(3) Judicial review.
(4) Notice to registrants.
(d) Phase two.
(1) In general.
(2) Notice of intent to seek or not to seek reregistration.
(3) Missing or inadequate data.
(4) Time periods.
(5) Cancellation and removal.
(6) Suspensions and penalties.
(e) Phase three.
(1) Information about studies.
(2) Time periods.
(3) Cancellation.
(4) Guidelines.
(5) Monitoring.
(f) Phase four.
(1) Independent review and identification of outstanding data requirements.
(2) Time periods.
(3) Suspensions and penalties.
(g) Phase five.
(1) Data review.
(2) Reregistration and other actions.
(h) Compensation of data submitter.
(i) Fees.
(1) Initial fee for food or feed use pesticide active ingredients.
(2) Final fee for food or feed use pesticide active ingredients.
(3) Fees for other pesticide active ingredients.
(4) Reduction or waiver of fees for minor use and other pesticides.
(5) Maintenance fee.
(6) Other fees.
(7) Apportionment.
(j) Exemption of certain registrants.
(k) Reregistration and expedited processing fund.
(1) Establishment.
(2) Source and use.
(3) Expedited processing of similar applications.
(4) Unused funds.
(5) Accounting.
(1) Judicial review.
Sec. 5. Experimental use permits.
(a) Issuance.
(b) Temporary tolerance level.
(c) Use under permit.
(d) Studies.
(e) Revocation.
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Sec. 1
(f) State issuance of permits.
(g) Exemption for agricultural research agencies.
Sec. 6. Administrative review; suspension.
(a) Cancellation after five years.
(1) Procedure.
(2) Information.
(b) Cancellation and change in classification or labels.
(c) Suspension.
(1) Order.
(2) Expedite hearing.
(3) Emergency order.
(4) Judicial review.
(d) Public hearings and scientific review.
(e) Conditional registration.
(f) General provisions.
(1) Voluntary cancellation.
(2) Publication of notice.
(g) Notice for stored pesticides with canceled or suspended registrations.
(1) In general.
(2) Copies.
(h) Judicial review.
Sec. 7. Registration of establishments.
(a) Requirements.
(b) Registration.
(c) Information required.
(d) Confidential records and information.
Sec. 8. Records.
(a) Requirement.
(b) Inspection.
Sec. 9. Inspection of establishments, etc.
(a) In general.
(b) Warrants.
(c) Enforcement.
(1) Certification of facts to Attorney 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 multinational pesticide producers.
Sec. 11. Use of restricted use pesticides; applicators.
(a) Certification procedure.
(1) Federal certification.
(2) State certification.
(b) State plans.
(c) Instruction in integrated pest management techniques.
(d) In general.
(e) 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.
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(b) Criminal penalties.
(1) In general.
(2) Private applicator.
(8) Disclosure of information.
(4) Acts of officers, agents, etc.
Sec. 15. Indemnities.
(a) General indemnification.
(1) In general.
(2) Exception.
(3) Report.
(4) Appropriation.
(b) Indemnification of end users, dealers, and distributors.
(1) End users.
(2) Dealers and distributors.
(3) Source.
(4) Administrative settlement.
(c) Amount of payment.
(1) In general.
(2) Special rule.
Sec. 16. Administrative procedure; judicial review.
(a) District court review.
(b) Review by Court of Appeals.
(c) Jurisdiction of district courts. t
(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 devices.
(d) Cooperation in international efforts.
(e) Regulations.
Sec. 18. Exemption of Federal and State agencies.
Sec. 19. Storage, disposal, transportation, and recall.
(a) Storage, disposal, and transportation.
(1) Data requirements and registration of pesticides.
(2) Pesticides.
(3) Containers, rinsates, and other materials.
(b) Recalls.
(1) In general.
(2) Voluntary recall.
(8) Mandatory recall.
(4) Recall procedure.
(5) Contents of recall plan.
(6) Requirements or procedures.
(c) Storage costs.
(1) Submission of plan.
(2) Reimbursement.
(d) Administration of storage, disposal, transportation, and recall programs.
(1) Voluntary agreements.
(2) Rule and regulation review.
(3) Limitations.
(4) Seizure and penalties.
(e) Container design.
(1) Procedures.
(2) Compliance.
(f) Pesticide residue removal.
(1) Procedures.
(2) Compliance.
(3) Solid Waste Disposal Act.
(g) Pesticide container study.
(1) Study.
(2) Report.
, (h) Relationship to Solid Waste Disposal Act.
Sec. 20. Research and monitoring.
(a) Research.
(b) National monitoring plan.
(c) Monitoring.
Sec. 21. Solicitation of comments; notice of public hearings.
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(a) Secretary of Agriculture.
(b) Views. .
(c) Notice.
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.
(a) In general.
(b) Uniformity.
(c) Additional uses.
Sec. 25. Authority of Administrator.
(a) In General.
(1) Regulations.
(2) Procedure.
(3) Congressional committees.
(4) Congressional review of regulations.
(b) Exemption of pesticides.
(c) Other authority.
(d) Scientific advisory panel.
Sec. 26. State primary enforcement responsibility.
(a) In general.
(b) Special rules.,
(c) Administrator.
Sec. 27. Failure by the State to assure enforcement of State pesticide use
regulations.
(a) Referral.
• (b) Notice. '
(c) Construction.
Sec. 28. Identification of pests; cooperation with Department of Agriculture's
program.
Sec. 29. Annual report.
Sec. 30. Severability.
Sec. 31. Authorization for appropriations.
SEC. 2. [136] 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, de-
foliant, 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 artifi-
cially accelerate the drying of plant tissue.
(b) ADMINISTRATOR.—The term "Administrator" means the Ad-
ministrator of the Environmental Protection Agency.
(c) ADULTERATED.—The term "adulterated" applies to any pesti-
cide if—
(1) its strength or purity falls below the professed standard of
quality as expressed on its labeling under which it is sold;
(2) any substance has been substituted wholly or in part for
the pesticide; or
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(3) any valuable constituent of the pesticide has been wholly
or in part abstracted.
(d) ANIMAL.—The term "animal" means all vertebrate and inver-
tebrate species, including but not limited to man and other mam-
mals, birds, fish, and shellfish.
(e) CERTIFIED APPLICATOR, ETC.—
(1) CERTIFIED APPLICATOR.—The term "certified applicator"
means any individual who is certified under section 4 *1 as au-
thorized to use or supervise the use of any pesticide which is
classified for restricted use. Any applicator who holds or ap-
plies registered pesticides, or use dilutions of registered pesti-
cides 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 certified 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 compensa-
tion other than trading of personal services between producers
of agricultural commodities) on the property of another person.
(3) COMMERCIAL APPLICATOR.—The term "commercial applica-
tor" means an applicator (whether or not he is a private appli-
cator 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 para-
graph (2).
(4) UNDER THE DIRECT SUPERVISION OF A CERTIFIED APPLICA-
TOR.—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 applied by a competent person
acting under the instructions and control of a certified applica-
tor who is available if and when needed, even though such cer-
tified applicator is not physically present at the time and place
the pesticide is applied.
(f) 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 con-
trivance (other than a firearm) which is intended for trapping, de-
stroying, 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.
•So in original. Probably should be "section 11"
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(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) FUNGUS.—The term "fungus" means any non-chlorophyll-
bearing thallophyte (that is, any non-chlorophyll-bearing plant of a
lower order than mosses and liverworts), as for example, rust,
smut, mildew, mold, yeast, and bacteria, except those on or in
living man or other animals and those on or in processed food, bev-
erages, or Pharmaceuticals.
(1) IMMINENT HAZARD.—The term "imminent hazard" means a
situation which exists when the continued use of a pesticide during
the tune required for cancellation proceeding would be likely to
result hi unreasonable adverse effects 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 statement which contains—
(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, calculat-
ed as elementary arsenic.
(o) INSECT.—The term "insect" means any of the numerous small
invertebrate animals generally having the body more or less obvi-
ously segmented, for the most part belonging to the class insecta,
comprising six-legged, usually winged forms, as for example, bee-
tles, 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 litera-
ture accompanying the pesticide or device, except to cur-
rent official publications of the Environmental Protection
Agency, the United States Departments of Agriculture and
Interior, the Department of Health and Human Services,
State experiment stations, State agricultural colleges, and
other similar Federal or State institutions or agencies au-
thorized by law to conduct research in the field of pesti-
cides.
(q) MlSBRANDED.—
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(1) A pesticide is misbranded if—
(A) its labeling bears any statement, design, or graphic
representation 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 estab-
lished by the Administrator pursuant to section 25(c)(3);
(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 as-
signed 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 con-
spicuousness (as compared with other words, statements,
designs, or graphic matter in the labeling) and in such
terms as to render it likely to be read and understood by
the ordinary individual under customary conditions of pur-
chase and use;
(F) the labeling accompanying it does not contain direc-
tions for use which are necessary for effecting the purpose
for which the product is intended and if complied with, to-
gether with any requirements imposed under section 3(d)
of this Act, are adequate to protect health and the environ-
ment;
(G) the label does not contain a warning or caution state-
ment which may be necessary and if complied with, to-
gether with any requirements imposed under section 3(d)
of this Act, is adequate to protect health and the environ-
ment; or
(H) in the case of a pesticide not registered in accord-
ance with section 3 of this Act and intended for export, the
label does not contain, in words prominently placed there-
on with such conspicuousness (as compared with other
words, statements, designs, or graphic matter in the label-
ing) as to render it likely to be noted by the ordinary indi-
vidual 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 dis-
played under customary conditions of purchase, except
that a pesticide is not misbranded under this subpara-
graph 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 state-
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Sec. 2
ment 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 out-
side container or wrapper of the retail package, if there be
one, through which the required information on the imme-
diate container cannot be clearly read, a label bearing—
(i) the name and address of the producer, registrant,
or person for whom produced;
(ii) the name, brand, or trademark under which the
pesticide is sold;
(iii) the net weight or measure of the content, except
that the Administrator may permit reasonable vari-
ations; and
(iv) when required by regulation of the Administra-
tor to effectuate the purposes of this Act, the registra-
tion number assigned to the pesticide under this Act,
and the use classification; and
(D) the pesticide contains any substance or substances in
quantities highly toxic to man, unless the label shall bear,
in addition to any other matter required by this Act—
(i) the skull and crossbones;
(ii) the word "poison" prominently in red on a back-
ground of distinctly contrasting color; and
(iii) a statement of a practical treatment (first aid or
otherwise) in case of poisoning by the pesticide.
(r) NEMATODE.—The term "nematode" means invertebrate ani-
mals 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, partner-
ship, association, corporation, "or any organized group of persons
whether incorporated or not.
(t) PEST.—The term "pest" means (1) any insect, rodent, nema-
tode, 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 Administrator declares to
be a pest under section 25(c)(l).
(u) PESTICIDE.—The term "pesticide" means (1) any substance or
mixture of substances intended for preventing, destroying, repel-
ling, or mitigating any pest, and (2) any substance or mixture of
substances intended for use as a plant regulator, defoliant, or desic-
cant, except that the term "pesticide" shall not include any article
that is a "new animal drug within the meaning of section 201(w)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(w)),
that has been determined by the Secretary of Health and Human
Services not to be a new animal drug by a regulation establishing
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12
conditions of use for the article, or that is an animal feed within
the meaning of section 201(x) of such Act (21 U.S.C. 321(x)) bearing
or containing a new animal drug.
(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, nutritional
chemicals, plant inoculants, and soil amendments. Also, the term
plant regulator" shall not be required to include any of such of
those nutrient mixtures or soil amendments as are commonly
known as vitamin-hormone horticultural products, intended for im-
provement, maintenance, survival, health, and propagation of
plants, and as are not for pest destruction and are nontoxic, non-
poisonous in the undiluted packaged concentration.
(w) PRODUCER AND PRODUCE.—The term "producer" means the
person who manufacturers, prepares, compounds, propagates, or
processes any pesticide or device or active ingredient used in pro-
ducing a pesticide. The term "produce" means to manufacture, pre-
pare, compound, propagate, or process any pesticide or device or
active ingredient used in producing a pesticide. The dilution by in-
dividuals of formulated pesticides for their own use and according
to the directions on registered labels shall not of itself result in
such individuals 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 en-
vironment" mean protection against any unreasonable adverse ef-
fects 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 reregistra-
tion.
(aa) STATE.—The term "State" means a State, the District of Co-
lumbia, 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.
(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 pro-
ducing a pesticide is produced, or held, for distribution or sale.
(ee) To USE ANY REGISTERED PESTICIDE IN A MANNER INCONSIST-
ENT WITH ITS LABELING.—The term "to use any registered pesticide
in a manner inconsistent with its labeling" means to use any regis-
tered pesticide in a manner not permitted by the labeling, except
that the term shall not include (1) applying a pesticide at any
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Sec. 3
dosage, concentration, or frequency less than that specified on the
labeling unless the labeling specifically prohibits deviation from
the specified dosage, concentration, or frequency, (2) applying a pes-
ticide 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 pe'sts would cause an unreasonable ad-
verse effect on the environment, (3) employing any method of appli-
cation not prohibited by the labeling unless the labeling specifical-
ly states that the product may be applied only by the methods spec-
ified on the labeling, (4) mixing a pesticide or pesticides with a fer-
tilizer when such mixture is not prohibited by the labeling, (5) any
use of a pesticide in conformance with section 5, 18, or 24 of this
Act, or (6) any use of a pesticide in a manner that the Administra-
tor determines to be consistent with the purposes of this Act. 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 regu-
lation or advisory opinion specifically requires the use of definite
amounts of dilution.
(ff) OUTSTANDING DATA REQUIREMENT.— "
(1) IN GENERAL.—The term "outstanding data requirement
means a requirement for any study, information, or data that
is necessary to make a determination under section 3(cX5) and
which study, information, or data—
(A) has not been submitted to the Administrator; or
(B) if submitted to the Administrator, the Administrator
has determined must be resubmitted because it is not
valid, complete, or adequate to make a determination
under section 3(c)(5) and the regulations and guidelines
issued under such section.
(2) FACTORS.—In making a determination under paragraph
(1)(B) respecting a study, the Administrator shall examine, at a
minimum, relevant protocols, documentation of the conduct
and analysis of the study, and the results of the study to deter-
mine whether the study and the results of the study fulfill the
data requirement for which the study was submitted to the
Administrator.
(gg) To DISTRIBUTE OR SELL.—The term "to distribute or sell"
means to distribute, sell, offer for sale, hold for distribution, hold
for sale, hold for shipment, ship, deliver for shipment, release for
shipment, or receive and (having so received) deliver or offer to de-
liver. The term does not include the holding or application of regis-
tered pesticides or use dilutions thereof by any applicator who pro-
vides a service of controlling pests without delivering any unap-
plied pesticide to any person so served.
SEC. 3. [136a] REGISTRATION OF PESTICIDES.
(a) REQUIREMENT OF REGISTRATION.—Except as provided by this
Act, no person in any State may distribute or sell to any person
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Sec. 3
FIFRA
14
any pesticide that is not registered under this Act. To the extent
necessary to prevent unreasonable adverse effects on the environ-
ment, the Administrator may by regulation limit the distribution,
sale, or use in any State of any pesticide that is not registered
under this 'Act and that is not the subject of an experimental use
permit under section 5 or an emergency exemption under section
18.
(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 an-
other 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 es-
tablishment; 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 person 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 direc-
tions for its use;
(D) except as otherwise provided in paragraph (2)(D), 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 appear
in the public literature or that previously had been sub-
mitted to the Administrator and that the Administrator
may consider in accordance with the following provisions:
(i) with respect to pesticides containing active ingre-
dients that are initially registered under this Act after
the date of enactment of the Federal Pesticide Act of
1978 [September 30, 1978], data submitted to support
the application for the original registration of the pes-
ticide, or an application for an amendment adding any
new use to the registration and that pertains solely to
such new use, shall not, without the written permis-
sion of the original data submitter, be considered by
the Administrator to support an application by an-
other person during a period of ten years following the
date the Administrator first registers the pesticide,
except that such permission shall not be required in
the case of defensive data;
(ii) except as otherwise provided in clause (i), with
respect to data submitted after December 31, 1969, by
an applicant or registrant to support an application
for registration, experimental use permit, or amend-
ment adding a new use to an existing registration, to
support or maintain in effect an existing registration,
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15
FIFRA
Sec. 3
or for reregistration, the Administrator 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 re-
ferred to as the "applicant") within the fifteen-year
period following the date the data were originally sub-
mitted only if the applicant has made an offer to com-
pensate the original data submitter and submitted
such offer to the Administrator accompanied by evi-
dence 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 submit-
ter and the applicant, or, failing such agreement, bind-
ing arbitration under this subparagraph. If, at the end
oflninety days after the date of delivery to the original
data submitter 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
binding arbitration proceedings by requesting the Fed-
eral Mediation 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 instances of such fraud, misrepre-
sentation, or other misconduct. The parties to the arbi-
tration shall share equally in the payment of the fee
and expenses of the arbitrator. If the Administrator
determines that an original data submitter has failed
to participate in a procedure for reaching an agree-
ment 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 original
data submitter shall forfeit the right to compensation
for the use of the data hi support of the application.
Notwithstanding any other provision of this Act, if the
Administrator determines that an applicant has failed
to participate in a procedure for reaching an agree-
ment or hi 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 Adminis-
trator shall deny the application or cancel the regis-
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Sec. 3
FIFRA
16
tration of the pesticide in support of which the data
were used without further hearing. Before the Admin-
istrator takes action under either of the preceding two
sentences, the Administrator shall furnish to the af-
fected person, by certified mail, notice of intent to
take action and allow fifteen days from the date of de-
livery of the notice for the affected person to respond.
If a registration is denied or canceled under this sub-
paragraph, the Administrator may make such order as
the Administrator deems appropriate concerning the
continued sale and use of existing stocks of such pesti-
cide. 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 clauses (i) and (ii), the
Administrator may consider such item of data in sup-
port 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) DATA IN SUPPORT OF REGISTRATION.—
(A) The Administrator shall publish guidelines specify-
ing the kinds of information which will be required to sup-
port the registration of a pesticide and shall revise such
guidelines from time to time. If thereafter he requires any
additional kind of information under subparagraph (B) of
this paragraph, he shall permit sufficient time for appli-
cants to obtain such additional information. The Adminis-
trator, in establishing standards for data requirements for
the registration of pesticides with respect to minor uses,
shall make such standards commensurate with the antici-
pated 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 poten-
tial national volume of use, extent of distribution, and the
impact of the cost of meeting the requirements on the in-
centives for any potential registrant to undertake the de-
velopment of the required data. Except as provided by sec-
tion 10, within 30 days after the Administrator registers a
pesticide under this Act he shall make available to the
public the data called for in the registration statement to-
gether with such other scientific information as he deems
relevant to his decision.
(BXi) If the Administrator determines that additional
data are required to maintain in effect an existing regis-
tration of a pesticide, the Administrator shall notify all ex-
isting registrants of the pesticide to which the determina-
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17
FIFRA
Sec. 3
tion relates and provide a list of such registrants to any
interested person.
(ii) Each registrant of such pesticide shall provide evi-
dence within ninety days after receipt of notification that
it is taking appropriate steps to secure the additional data
that are required. Two or more registrants may agree to
develop jointly, or to share in the cost of developing, such
data if they agree and advise the 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 support
of maintenance of such registration. The Administrator
shall issue a notice of intent to suspend the registration of
a pesticide in accordance with the procedures prescribed
by clause (iv) if a registrant fails to comply with this
clause.
(iii) If, at the end of sixty days after advising the Admin-
istrator of their agreement to develop jointly, or share in
the cost of developing data, the registrants have not fur-
ther agreed on the terms of the data development arrange-
ment or on a procedure for reaching such agreement, any
of such registrants may initiate binding arbitration pro-
ceedings by requesting the Federal Mediation and Concil-
iation 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, misrepresen-
tation, or other misconduct by one of the parties to the ar-
bitration or the arbitrator where there is a verified com-
plaint with supporting affidavits attesting to specific in-
stances of such fraud, misrepresentation, or other miscon-
duct. All parties to the arbitration shall share equally in
the payment of the fee and expenses of the arbitrator. The
Administrator shall issue a notice of intent to suspend the
registration of a pesticide in accordance with the proce-
dures prescribed by clause (iv) if a registrant fails to
comply with this clause.
(iv) Notwithstanding any other provision of this Act, if
the Administrator determines that a registrant, within the
time required by the Administrator, has failed to take ap-
propriate steps to secure the data required under this sub-
paragraph, to participate in a procedure for reaching
agreement concerning a joint data development arrange-
ment under this subparagraph or in an arbitration pro-
ceeding 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 subparagraph, the Administrator may issue a notice
of intent to suspend such registrant's registration of the
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Sec. 3
FIFRA
18
pesticide for which additional data is required. The Admin-
istrator may include in the notice of intent to suspend
such provisions as the Administrator deems appropriate
concerning the continued sale and use of existing stocks of
such pesticide. Any suspension proposed under this sub-
paragraph 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 with the require-
ments that served as a basis for the notice of intent to sus-
pend. If a hearing is requested, a hearing shall be conduct-
ed under section 6(d) of this Act. The only matters for reso-
lution 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 existing stocks is consistent with this Act. If a hearing is
held, a decision after completion of such hearing shall be
final. Notwithstanding 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 hear-
ing. Any registration suspended under this subparagraph
shall be reinstated by the Administrator if the Administra-
tor determines that the registrant has complied 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 paragraph (1)(D). Whenever
such data are submitted jointly by two or more registrants,
an agent shall be agreed on at the time of the joint sub-
mission to handle any subsequent data compensation mat-
ters for the joint submitters of such data.
(C) Within nine months after the date of enactment of
this subparagraph [September 30, 1978], the Administrator
shall, by regulation, prescribe simplified procedures for the
registration of pesticides, which shall include the provi-
sions of subparagraph (D) of this paragraph.
(D) EXEMPTION.—No applicant for registration of a pesti-
cide who proposes to purchase a registered pesticide from
another producer in order to formulate such purchased
pesticide into the pesticide that is the subject of the appli-
cation 3-1 shall be required to—
(i) submit or cite data pertaining to such purchased
product; or
ro 1,°i2(blfo&M of t5e/(*Jeral Insecticide, Fungicide, and Rodenticide Act Amendments
of 1988 (P.L. 100-532) amended this subparagraph by striking out "an end use product" and in-
serting in lieu thereof "the pesticide that is the subject of the application". Before the amend-
ment, the text of this subparagraph contained the phrase "an end-use product", with a hyphen.
The amendment was executed to this subparagraph to effectuate the probable intent of Con-
gress.
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19
FIFRA
Sec. 3
(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.—
(A) The Administrator shall review the data after re-
ceipt of the application and shall, as expeditiously as possi-
ble, either register the pesticide in accordance with para-
graph (5), or notify the applicant of his determination that
it does not comply with the provisions of the Act in accord-
ance with paragraph (6).
(B)(i) The Administrator shall, as expeditiously as possi-
ble, review and act on any application received by the Ad-
ministrator that—
(I) proposes the initial or amended registration of an
end-use pesticide that, if registered as proposed, would
be identical or substantially similar in composition
and labeling to a currently-registered pesticide identi-
fied in the application, or that would differ in composi-
tion and labeling from such currently-registered pesti-
cide only in ways that would not significantly increase
the risk of unreasonable adverse effects on the envi-
ronment; or
(II) proposes an amendment to the registration of a
registered pesticide that does not require scientific
review of data.
(ii) In expediting the review of an application for an
action described in clause (i), the Administrator shall—
(I) within 45 days after receiving the application,
notify the registrant whether or not the application is
complete and, if the application is found to be incom-
plete, reject the application;
(II) within 90 days after receiving a complete appli-
cation, notify the registrant if the application has been
granted or denied; and
(III) if the application is denied, notify the registrant
in writing of the specific reasons for the denial of the
application.
(4) NOTICE OF APPLICATION.—The Administrator shall publish
in the Federal Register, promptly after receipt of the state-
ment and other data 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 submit-
ted comply with the requirements of this Act;
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Sec. 3
FIFRA
20
(C) it will perform its intended function without unrea-
sonable adverse effects on the environment; and
(D) when used in accordance with widespread and com-
monly recognized practice it will not generally cause un-
reasonable 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 requirements of this paragraph, one should
not be registered in preference to the other. In considering an
application for the registration of a pesticide, the Administra-
tor may waive data requirements pertaining to efficacy, in
which event the Administrator may register the pesticide with-
out determining that the pesticide's composition is such as to
warrant 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 that the Administrator shall waive
data requirements pertaining to efficacy for use of the pesti-
cide in such State.
(6) DENIAL OF REGISTRATION.—If the Administrator deter-
mines 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 applicant corrects the con-
ditions and notifies the Administrator thereof during 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 publish in the Federal Register
notice of such denial of registration and the reasons therefor.
Upon such notification, the applicant for registration or other
interested person with the concurrence of the applicant shall
have the same remedies as provided for in section 6.
(7) REGISTRATION UNDER SPECIAL CIRCUMSTANCES.—Notwith-
standing the provisions of paragraph (5)—
(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 iden-
tical 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 appli-
cant would not significantly increase the risk of any un-
reasonable adverse effect on the environment. An appli-
cant seeking conditional registration or amended registra-
tion under this subparagraph shall submit such data as
would be required to obtain registration of a similar pesti-
cide under paragraph (5). If the applicant is unable to
submit an item of data because it has not yet been gener-
ated, the Administrator may register or amend the regis-
tration of the pesticide under such conditions as will re-
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21
FIFRA
Sec. 3
quire the submission of such data not later than the time
such data are required to be submitted with respect to
similar pesticides already registered under this Act.
(B) The Administrator may conditionally amend the reg-
istration of a pesticide to permit additional uses of such
pesticide notwithstanding that data concerning the pesti-
cide may be insufficient to support an unconditional
amendment, if the Administrator determines 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 signifi-
cantly increase the risk of any unreasonable adverse effect
on the environment. Notwithstanding the foregoing provi-
sions of this subparagraph, no registration of a pesticide
may be amended to permit an additional use of such pesti-
cide 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 di-
etary exposure enumerated in regulations issued under
this Act, andjduring the pendency of any risk-benefit eval-
uation 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 con-
currence 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 subparagraph shall submit such
data as would be required to obtain registration of a simi-
lar pesticide under paragraph (5). If the applicant is
unable to submit an item of data (other than data pertain-
ing to the proposed additional use) because it has not yet
been generated, the Administrator may amend the regis-
tration under such conditions as will require the submis-
sion of such data not later than the time such data are re-
quired to be submitted with respect to similar pesticides
already registered under this Act.
(C) The Administrator may conditionally register a pesti-
cide containing an active ingredient not contained in any
currently registered pesticide for a period reasonably suffi-
cient for the generation and submission of required data
(which are lacking because a period reasonably sufficient
for generation of the data has not elapsed since the Ad-
ministrator 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 conditions as the Administrator may
prescribe. A conditional registration under this subpara-
graph shall be granted only if the Administrator deter-
mines that use of the pesticide during such period will not
cause any unreasonable adverse effect on the environment,
and that use of the pesticide is in the public interest.
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Sec. 3
FIFRA
22
(8) INTERIM ADMINISTRATIVE REVIEW.—Notwithstanding any
other provision of this Act, the Administrator may not initiate
a public interim 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, required under this Act,
unless such interim administrative process is based on a vali-
dated test or other significant evidence raising prudent con-
cerns of unreasonable adverse risk to man or to the environ-
ment. Notice of the definition of the terms "validated test" and
"other significant evidence" as used herein shall be published
by the Administrator in the Federal Register.
(d) CLASSIFICATION OF PESTICIDES.—
(1) CLASSIFICATION FOR GENERAL USE, RESTRICTED USE, OR
BOTH.—
(A) As a part of the registration of a pesticide the Ad-
ministrator shall classify it as being for general use or for
restricted use. 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 regis-
tered should be for restricted use, he shall classify it for
both general use and restricted use. Pesticide uses may be
classified by regulation on the initial classification and
registered pesticides may be classified prior to reregistra-
tion. 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. The Administrator 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 applied in accordance with its directions for use,
warnings and cautions and for the uses for which it is reg-
istered, 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 particu-
lar use or uses of the pesticide to which the determination
applies, for general use.
(C) If the Administrator determines that the pesticide,
when applied in accordance with its directions for use,
warnings and cautions and for the uses for which it is reg-
istered, or for one or more of such uses, or in accordance
with a widespread and commonly recognized practice, may
generally cause, without additional regulatory restrictions,
unreasonable adverse effects on the environment, includ-
ing injury to the applicator, he shall classify the pesticide,
or the particular 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 be-
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23
FIFRA
Sec. 3
cause of a determination that the acute dermal or in-
halation 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 classifica-
tion applies only by or under the direct supervision of
a certified applicator.
(ii) If the Administrator classifies a pesticide, or one
or more uses of such pesticide, for restricted use be-
cause of a determination that its use without addition-
al regulatory restriction may cause unreasonable ad-
verse effects on the environment, the pesticide shall be
applied for any use to which the determination applies
only by or under the direct supervision of a certified
applicator, or subject to such other restrictions as the
Administrator may provide by regulation. Any such
regulation shall be reyiewable in the appropriate court
of appeals upon petition of a person adversely affected
filed within 60 days of the publication of the regula-
tion in final form.
(2) CHANGE IN CLASSIFICATION.—If the Administrator deter-
mines that a change hi the classification of any use of a pesti-
cide 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 pub-
lish the proposed change in the Federal Register. The regis-
trant, or other interested person with the concurrence of the
registrant, may seek relief from such determination under sec-
tion 6(b).
(3) CHANGE IN CLASSIFICATION FROM RESTRICTED USE TO GEN-
ERAL USE.—The registrant of any pesticide with one or more
uses classified for restricted use may petition the Administra-
tor to change any such classification from restricted to general
use. Such petition shall set out the basis for the registrant's po-
sition that restricted use classification is unnecessary because
classification of the pesticide for general use would not cause
unreasonable adverse effects on the environment. The Admin-
istrator, within sixty days after receiving such petition, shall
notify the registrant whether the petition has been granted or
denied. Any denial shall contain an explanation therefor and
any such denial shall be subject to judicial review under sec-
tion 16 of this Act.
(e) PRODUCTS WITH SAME FORMULATION AND CLAIMS.—Products
which have the same formulation, are manufactured by the same
Eerson, the labeling of which contains the same claims, and the
ibels of which bear a designation identifying the product as the
same pesticide may be registered as a single pesticide; and addi-
tional names and labels shall be added to the registration by sup-
plemental statements.
(f) MISCELLANEOUS.—
(1) EFFECT OF CHANGE OF LABELING OR FORMULATION.—If the
labeling or formulation for a pesticide is changed, the registra-
tion shall be amended to reflect such change if the Administra-
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Sec. 4
FIFRA
24
tor determines that the change will not violate any provision
of this Act.
(2) REGISTRATION NOT A DEFENSE.—In no event shall registra-
tion of an article be construed as a defense for the commission
of any offense under this Act. As long as no cancellation pro-
ceedings 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 con-
nection with consideration of any registration or application
for registration under this section, the Administrator may con-
sult with any other Federal agency.
SEC. 4. [136b] REREGISTRATION OP REGISTERED PESTICIDES.
(a) GENERAL RULE.—The Administrator shall reregister, in ac-
cordance with this section, each registered pesticide containing any
active ingredient contained in any pesticide first registered before
November 1, 1984, except for any pesticide as to which the Admin-
istrator has determined, after November 1, 1984, and before the ef-
fective date of this section [December 24, 1988], that—
(1) there are no outstanding data requirements; and
(2) the requirements of section 3(c)(5) have been satisfied.
(b) REREGISTRATION PHASES.—Reregistrations of pesticides under
this section shall be carried out in the following phases:
(1) The first phase shall include the listing under subsection
(c) of the active ingredients of the pesticides that will be rere-
gistered.
(2) The second phase shall include the submission to the Ad-
ministrator under subsection (d) of notices by registrants re-
specting their intention to seek reregistration, identification by
registrants of missing and inadequate data for such pesticides,
and commitments by registrants to replace such missing or in-
adequate data within the applicable time period.
(3) The third phase shall include submission to the Adminis-
trator by registrants of the information required under subsec-
tion (e).
(4) The fourth phase shall include an independent, initial
review by the Administrator under subsection (f) of submis-
sions under phases two and three, identification of outstanding
data requirements, and the issuance, as necessary, of requests
for additional data.
(5) The fifth phase shall include the review by the Adminis-
trator under subsection (g) of data submitted for reregistration
and appropriate regulatory action by the Administrator.
(c) PHASE ONE.—
(1) PRIORITY FOR REREGISTRATION.—For purposes of the rereg-
istration of the pesticides described in subsection (a), the Ad-
ministrator shall list the active ingredients of pesticides and
shall give priority to, among others, active ingredients (other
than active ingredients for which registration standards have
been issued before the effective date of this section [December
24, 1988]) that—
(A) are in use on or in food or feed and may result in
postharvest residues;
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25
FIFRA
Sec. 4
(B) may result in residues of potential toxicological con-
cern in potable ground water, edible fish, or shellfish;
(C) have been determined by the Administrator before
the effective date of this section [December 24, 1988] to
have significant outstanding data requirements; or
(D) are used on crops, including in greenhouses and
nurseries, where worker exposure is most likely to occur.
(2) REREGISTRATION LISTS.—For purposes of reregistration
under this section, the Administrator shall by order—
(A) not later than 70 days after the effective date of this
section [December 24, 1988], list pesticide active ingredi-
ents for which registration standards have been issued
before such effective date;
(B) not later than 4 months after such effective date, list
the first 150 pesticide active ingredients, as determined
under paragraph (1);
(C) not later than 7 months after such effective date, list
the second 150 pesticide active ingredients, as determined
under paragraph (1); and
(D) npt later than 10 months after such effective date,
list the remainder of the pesticide active ingredients, as
determined under paragraph (1).
Each list shall be published in the Federal Register.
(3) JUDICIAL REVIEW.—The content of a list issued by the Ad-
ministrator under paragraph (2) shall not be subject to judicial
review.
(4) NOTICE TO REGISTRANTS.—On the publication of a list of
pesticide active ingredients under paragraph (2), the Adminis-
trator shall send by certified mail to the registrants of the pes-
ticides containing such active ingredients a notice of the time
by which the registrants are to notify the Administrator under
subsection (d) whether the registrants intend to seek or not to
seek reregistration of such pesticides.
(d) PHASE Two.—
(1) IN GENERAL.—The registrant of a pesticide that contains
an active ingredient listed under subparagraph (B), (C), or (D)
of subsection (c)(2) shall submit to the Administrator, within
the time period prescribed by paragraph (4), the notice de-
scribed in paragraph (2) and any information, commitment, or
offer described in paragraph (3).
(2) NOTICE OF INTENT TO SEEK OR NOT TO SEEK REREGISTRA-
TION.—
(A) The registrant of a pesticide containing an active in-
gredient listed under subparagraph (B), (C), or (D) of sub-
section (c)(2) shall notify the Administrator by certified
mail whether the registrant intends to seek or does not
intend to seek reregistration of the pesticide.
(B) If a registrant submits a notice under subparagraph
(A) ,of an intention not to seek reregistration of a pesticide,
the Administrator shall publish a notice,in the Federal
Register stating that such a notice has been submitted.
(3) MISSING OR INADEQUATE DATA.—Each registrant of a pesti-
cide that contains an active ingredient listed under subpara-
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Sec. 4
F1FRA
26
graph (B), (C), or (D) of subsection (cX2) and for which the regis-
trant submitted a notice under paragraph (2) of an intention to
seek reregistration of such pesticide shall submit to the
Administrator—
(A) in accordance with regulations issued by the Admin-
istrator under section 3, an identification of—
(i) all data that are required by regulation to sup-
port the registration of the pesticide with respect to
such active ingredient;
(ii) data that were submitted by the registrant previ-
ously in support of the registration of the pesticide
that are inadequate to meet such regulations; and
(iii) data identified under clause (i) that have not
been submitted to the Administrator; and
(B) either—
(i) a commitment to replace the data identified
under subparagraph (A)(ii) and submit the data identi-
fied under subparagraph (A)(iii) within the applicable
time period prescribed by paragraph (4KB); or
(ii) an offer to share in the cost to be incurred by a
person who has made a commitment under clause (i)
to replace or submit the data and an offer to submit to
arbitration as described by section 3(c)(2)(B) with.
regard to such cost sharing.
For purposes of a submission by a registrant under subpara-
graph (A)(ii), data are inadequate if the data are derived from
a study with respect to which the registrant is unable to make
the certification prescribed by subsection (e)(l)(G) that the reg-
istrant possesses or has access to the raw data used in or gen-
erated by such study. For purposes of a submission by a regis-
trant under such subparagraph, data shall be considered to be
inadequate if the data are derived from a study submitted
before January 1, 1970, unless it is demonstrated to the satis-
faction of the Administrator that such data should be consid-
ered to support the registration of the pesticide that is to be
reregistered.
(4) TIME PERIODS.—
(A) A submission under paragraph (2) or (3) shall be
made—
(i) in the case of a pesticide containing an active in-
gredient listed under subsection (c)(2)(B), not later
than 3 months after the date of publication of the list-
ing of such active ingredient;
(ii) in the case of a pesticide containing an active in-
gredient listed under subsection (c)(2XC), not later
than 3 months after the date of publication of the list-
ing of such active ingredient; and
(iii) in the case of a pesticide containing an active in-
gredient listed under subsection (c)(2)(D), not later
than 3 months after the date of publication of the list-
ing of such active ingredient.
On application, the Administrator may extend a time
period prescribed by this subparagraph if the Administra-
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27
FIFRA
Sec. 4
tor determines that factors beyond the control of the regis-
trant prevent the registrant from complying with such
period.
(B) A registrant shall submit data in accordance with a
commitment entered into under paragraph (3)(B) within a
reasonable period of tune, as determined by the Adminis-
trator, but not more than 48 months after the date the
registrant submitted the commitment. The Administrator,
on application of a registrant, may extend the period pre-
scribed by the preceding sentence by no more than 2 years
if extraordinary circumstances beyond the control of the
registrant prevent the registrant from submitting data
within such prescribed period.
(5) CANCELLATION AND REMOVAL.—
(A) If the registrant of a pesticide does not submit a
notice under paragraph (2) or (3) within the time pre-
scribed by paragraph (4)(A), the Administrator shall issue
a notice of intent to cancel the registration of such regis-
trant for such pesticide and shall publish the notice in the
Federal Register and allow 60 days for the submission of
comments on the notice. On expiration of such 60 days, the
Administrator, by order and without a hearing, may
cancel the registration or take such other action, including
extension of applicable time periods, as may be necessary
to enable reregistration of such pesticide by another
person.
(B)(i) If-
(I) no registrant of a pesticide containing an active
ingredient listed under subsection (c)(2) notifies the
Administrator under paragraph (2) that the registrant
intends to seek reregistration of any pesticide contain-
ing that active ingredient;
(II) no such registrant complies with paragraph
(3)(A);or
(III) no such registrant makes a commitment under
paragraph (3)(B) to replace or submit all data de-
scribed in clauses (ii) and (iii) of paragraph (3XA);
the Administrator shall publish in the Federal Register a
notice of intent to remove the active ingredient from the
list established under subsection (c)(2) and a notice of
intent to cancel the registrations of all pesticides contain-
ing such active ingredient and shall provide 60 days for
comment on such notice.
(ii) After the 60-day period has expired, the Administra-
tor, by order, may cancel any such registration without
hearing, except that the Administrator shall not cancel a
registration under this subparagraph if—
(I) during the comment period a person acquires the
rights of the registrant in that registration;
(II) during the comment period that person fur-
nishes a notice of intent to reregister the pesticide in
accordance with paragraph (2); and
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Sec. 4
FIFRA
28
(III) not later than 120 days after the publication of
the notice under this subparagraph, that person has
complied with paragraph (3) and the fee prescribed by
subsection (i)(l) has been paid.
(6) SUSPENSIONS AND PENALTIES.—The Administrator shall
issue a notice of intent to suspend the registration of a pesti-
cide in accordance with the procedures prescribed by section
3(cX2XBXiy) if the Administrator determines that (A) progress
is insufficient to ensure the submission of the data required for
such pesticide under a commitment made under paragraph
(8KB) within the tune period prescribed by paragraph (4)(B) or
(B) the registrant has not submitted such data to the Adminis-
trator within such time period.
(e) PHASE THREE.—
(1) INFORMATION ABOUT STUDIES.—Each registrant of a pesti-
cide that contains an active ingredient listed under subpara-
graph (B), (C), or (D) of subsection (c)(2) who has submitted a
notice under subsection (d)(2) of an intent to seek the reregis-
tration of such pesticide shall submit, in accordance with the
guidelines issued under paragraph (4), to the Administrator—
(A) a summary of each study concerning the active in-
gredient previously submitted by the registrant in support
of the registration of a pesticide containing such active in-
gredient and considered by the registrant to be adequate
to meet the requirements of section 3 and the regulations
issued under such section; •
(B) a summary of each study concerning the active in-
gredient previously submitted by the registrant in support
of the registration of a pesticide containing such active in-
gredient that may not comply with the requirements of
section 3 and the regulations issued under such section but
which the registrant asserts should be deemed to comply
with such requirements and regulations;
(C) a reformat of the data from each study summarized
under subparagraph (A) or (B) by the registrant concern-
ing chronic dosing, pncogenicity, reproductive effects, mu-
. tagenicity, neurotoxicity, teratogenicity, or residue chemis-
try of the active ingredient that were submitted to the Ad-
ministrator before January 1, 1982;
CD) where data described in subparagraph (C) are not re-
quired for the active ingredient by regulations issued
under section 3, a reformat of acute and subchronic dosing
data submitted by the registrant to the Administrator
before January 1, 1982, that the registrant considers to be
adequate to meet the requirements of section 3 and the
regulations issued under such section;
(E) an identification of data that are required to be sub-
mitted to the Administrator under section 6(a)(2) indicat-
ing an adverse effect of the pesticide;
(F) an identification of any other information available
that in the view of the registrant supports the registration;
(G) a certification that the registrant or the Administra-
tor possesses or has access to the raw data used in or gen-
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29
FIFRA
Sec. 4
erated by the studies that the registrant summarized
under subparagraph (A) or (B);
(H) either—
(i) a commitment to submit data to fill each out-
standing data requirement identified by the regis-
trant; or
(ii) an offer to share in the cost of developing such
data to be incurred by a person who has made a com-
mitment under clause (i) to submit such data, and an
offer to submit to arbitration as described by section
3(c)(2)(B) with regard to such cost sharing; and
(I) evidence of compliance with section 3(c)(l)(D)(ii) and
regulations issued thereunder with regard to previously
submitted data as if the registrant were now seeking the
original registration of the pesticide.
A registrant who submits a certification under subparagraph
(G) that is false shall be considered to have violated this Act
and shall be subject to the penalties prescribed by section 14.
(2) TIME PERIODS.—
(A) The information required by paragraph (1) shall be
submitted to the Administrator—
(i) in the case of a pesticide containing an active in-
gredient listed under subsection (c)(2)(B), not later
than 12 months after the date of publication of the
listing of such active ingredient;
(ii) in the case of a pesticide containing an active in-
gredient listed under subsection (c)(2)(C), not later
than 12 months after the date of publication of the
listing of such active ingredient; and
(iii) in the case of a pesticide containing an active in-
gredient listed under subsection (c)(2)(D), not later
than 12 months after the date of publication of the
listing of such active ingredient.
(B) A registrant shall submit data in accordance with a
commitment entered into under paragraph (1)(H) within a
reasonable period of time, as determined by the Adminis-
trator, but not more than 48 months after the date the
registrant submitted the commitment under such para-
graph. The Administrator, on application of a registrant,
may extend the period prescribed by the preceding sen-
tence by no more than 2 years if extraordinary circum-
stances beyond the control of the registrant prevent the
registrant from submitting data within such prescribed
period.
(3) CANCELLATION.—
(A) If the registrant of a pesticide fails to submit the in-
formation required by paragraph (1) within the time pre-
scribed by paragraph (2), the Administrator, by order and
without hearing, shall cancel the registration of such pesti-
cide.
(B)(i) If the registrant of a pesticide submits the informa-
tion required by paragraph (1) within the time prescribed
by paragraph (2) and such information does not conform to
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Sec. 4
FIFRA
30
the guidelines for submissions established by the Adminis-
trator, the Administrator shall determine whether the reg-
istrant made a good faith attempt to conform its submis-
sion to such guidelines.
(ii) If the Administrator determines that the registrant
made a good faith attempt to conform its submission to
such guidelines, the Administrator shall provide the regis-
trant a reasonable period of time to make any necessary
changes or corrections.
(iiiXD If the Administrator determines that the regis-
trant did not make a good faith attempt to conform its
submission to such guidelines, the Administrator may
issue a notice of intent to cancel the registration. Such a
notice shall be sent to the registrant by certified mail.
(II) The registration shall be canceled without a hearing
or further notice at the end of 30 days after receipt by the
registrant of the notice unless during that time a request
for a hearing is made by the registrant.
(HI) If a hearing is requested, a hearing shall be conduct-
ed under section 6(d), except that the only matter for reso-
lution at the hearing shall be whether the registrant made
a good faith attempt to conform its submission to such
guidelines. The hearing shall be held and a determination
made within 75 days after receipt of a request for hearing.
(4) GUIDELINES.—
(A) Not later than 1 year after the effective date of this
section [December 24, 1988], the Administrator, by order,
shall issue guidelines to be followed by registrants in—
(i) summarizing studies;
(ii) reformatting studies;
(iii) identifying adverse information; and
(iv) identifying studies that have been submitted
previously that may not meet the requirements of sec-
tion 3 or regulations issued under such section,
under paragraph (1).
(B) Guidelines issued under subparagraph (A) shall not
be subject to judicial review.
(5) MONITORING.—The Administrator shall monitor the
progress of registrants in acquiring and submitting the data re-
quired under paragraph (1).
(f) PHASE FOUR.—
(1) INDEPENDENT REVIEW AND IDENTIFICATION OF OUTSTANDING
DATA REQUIREMENTS.—
(A) The Administrator shall review the submissions of
all registrants of pesticides containing a particular active
ingredient under subsections (d)(3) and (e)(l) to determine
if such submissions identified all the data that are missing
or inadequate for such active ingredient. To assist the
review of the Administrator under this subparagraph, the
Administrator may require a registrant seeking reregistra-
tion to submit complete copies of studies summarized
under subsection (e)(l).
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31
FIFRA
Sec. 4
(B) The Administrator shall independently identify and
publish in the Federal Register the outstanding data re-
quirements for each active ingredient that is listed under
subparagraph (B), (C), or (D) of subsection (c)(2) and that is
contained in a pesticide to be reregistered under this sec-
, tion. The Administrator, at the same time, shall issue a
notice under section 3(c)(2)(B) for the submission of the ad-
ditional data that are required to meet such requirements.
(2) TIME PERIODS.—
(A) The Administrator shall take the action required by
paragraph (1)—
(i) in the case of a pesticide containing an active in-
gredient listed under subsection (c)(2)(B), not later
than 18 months after the date of the listing of such
active ingredient;
(ii) in the case of a pesticide containing an active in-
gredient listed under subsection (c)(2XC), not later
than 24 months after the date of the listing of such
active ingredient; and
(iii) in the case of a pesticide containing an active in-
gredient listed under subsection (c)(2)(D), not later
than 33 months after the date of the listing of such
active ingredient.
(B) If the Administrator issues a notice to a registrant
under paragraph (1)(B) for the submission of additional
data, the registrant shall submit such data within a rea-
sonable period of time, as determined by the Administra-
tor, but not to exceed 48 months after the issuance of such
notice. The Administrator, on application of a registrant,
may extend the period prescribed by the preceding sen-
tence by no more than 2 years if extraordinary circum-
stances beyond the control of the registrant prevent the
registrant from submitting data within such prescribed
period.
(3) 4-1 SUSPENSIONS AND PENALTIES.—The Administra-
tor shall issue a notice of intent to suspend the regis-
tration of a pesticide in accordance with the proce-
dures prescribed by section 3(c)(2)(B)(iv) if the Adminis-
trator determines that (A) tests necessary to fill an
outstanding data requirement for such pesticide have
not been initiated within 1 year after the issuance of a
notice under paragraph (1KB), or (B) progress is insuf-
ficient to ensure submission of the data referred to in
clause (A) within the time period prescribed by para-
graph (2)(B) or the required data have not been sub-
mitted to the Administrator within such time period.
(g) PHASE FIVE.—
(1) DATA REVIEW.—The Administrator shall conduct a thor-
ough examination of all data submitted under this section con-
cerning an active ingredient listed under subsection (c)(2) and
'''So in original. Margin of paragraph (3) should be aligned with margin of preceding para-
graph (2).
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Sec. 4
FIFRA
32
of all other available data found by the Administrator to be
relevant.
(2) REREGISTRATION AND OTHER ACTIONS.—
(A) Within 1 year after the submission of all data con-
cerning an active ingredient of a pesticide under subsec-
tion (f), the Administrator shall determine whether pesti-
cides containing such active ingredient are eligible for re-
registration. For extraordinary circumstances, the Admin-
istrator may extend such period for not more than 1 addi-
tional year.
(B) Before reregistering a pesticide, the Administrator
shall obtain any needed product-specific data regarding
the pesticide by use of section 3(cX2XB) and shall review
such data within 90 days after its submission. The Admin-
istrator shall require that data under this subparagraph
be submitted to the Administrator not later than 8 months
after a determination of eligibility under subparagraph (A)
has been made for each active ingredient of the pesticide,
unless the Administrator determines that a longer period
is required for the generation of the data.
(C) After conducting the review required by paragraph
(1) for each active ingredient of a pesticide and the review
required by subparagraph (B) of this paragraph, the Ad-
ministrator shall determine whether to reregister a pesti-
cide by determining whether such pesticide meets the re-
quirements of section 3(c)(5). If the Administrator deter-
mines that a pesticide is eligible to be reregistered, the Ad-
ministrator shall reregister such pesticide within 6 months
after the submission of the data concerning such pesticide
under subparagraph (B).
(D) If after conducting a review under paragraph (1) or
subparagraph (B) of this paragraph the Administrator de-
termines that a pesticide should not be reregistered, the
Administrator shall take appropriate regulatory action.
(h) COMPENSATION OP DATA SUBMITTER.—If data that are submit-
ted by a registrant under subsection (d), (e), (f), or (g) are used to
support the application of another person under section 3, the reg-
istrant who submitted such data shall be entitled to compensation
for the use of such data as prescribed by section 3(c)(lXD). In deter-
mining the amount of such compensation, the fees paid by the reg-
istrant under this section shall be taken into account.
(i) FEES —
(1) INITIAL FEE FOR FOOD OR FEED USE PESTICIDE ACTIVE INGRE-
DIENTS.—The registrants of pesticides that contain an active in-
gredient that is listed under subparagraph (B), (C), or (D) of
subsection (cX2) and that is an active ingredient of any pesti-
cide registered for a major food or feed use shall collectively
pay a fee of $50,000 on submission of information under para-
graphs (2) and (3) of subsection (d) for such ingredient.
(2) FINAL FEE FOR FOOD OR FEED USE PESTICIDE ACTIVE
INGREDIENTS.—
(A) The registrants of pesticides that contain an active
ingredient that is listed under subparagraph (B), (C), or (D)
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33
FIFRA
Sec. 4
of subsection (c)(2) and that is an active ingredient of any
pesticide registered for a major food or feed use shall col-
lectively pay a fee of $100,000—
(i) on submission of information for such ingredient
under subsection (e)(l) if data are reformatted under
subsection (e)(l)(C); or
(ii) on submission of data for such ingredient under
subsection (e)(2)(B) if data are not reformatted under
subsection (e)(l)(C).
(B) The registrants of pesticides that contain an active
ingredient that is listed under subsection (c)(2)(A) and that
is an active ingredient of any pesticide registered for a
major food or feed use shall collectively pay a fee of
$150,000 at such time as the Administrator shall prescribe.
(3) FEES FOR OTHER PESTICIDE ACTIVE INGREDIENTS.—
(A) The registrants of pesticides that contain an active
ingredient that is listed under subparagraph (B), (C), or (D)
of subsection (c)(2) and that is not an active ingredient of
any pesticide registered for a major food or feed use shall
collectively pay fees in amounts determined by the Admin-
istrator. Such fees may not be less than one-half of, nor
greater than, the fees required by paragraphs (1) and (2). A
registrant shall pay such fees at the times corresponding
to the times fees prescribed by paragraphs (1) and (2) are
to be paid.
(B) The registrants of pesticides that contain an active
ingredient that is listed under subsection (c)(2)(A) and that
is not an active ingredient of any pesticide that is regis-
tered for a major food or feed use shall collectively pay a
fee of not more than $100,000 and not less than $50,000 at
such tune as the Administrator shall prescribe.
(4) REDUCTION OR WAIVER OF FEES FOR MINOR USE AND OTHER
PESTICIDES.—
(A) An active ingredient that is contained only in pesti-
cides that are registered solely for agricultural or nonagri-
cultural minor uses, or a pesticide the value or volume of
use of which is small, shall be exempt from the fees pre-
scribed by paragraph (3).
(B) An antimicrobial active ingredient, the production
level of which does not exceed 1,000,000 pounds per year,
shall be exempt from the fees prescribed by paragraph (3).
For purposes of this subparagraph, the term "antimicro-
bial active ingredient" means any active ingredient that is
contained only in pesticides that are not registered for any
food or feed use and that are—
(i) sanitizers intended to reduce the number of living
bacteria or viable virus particles on inanimate surface
or in water or air;
(ii) bacteriostats intended to inhibit the growth of
bacteria in the presence of moisture;
(iii) disinfectants intended to destroy or irreversibly
inactivate bacteria, fungi, or viruses on surfaces or in-
animate objects;
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Sec. 4
FIFRA
34
(iv) sterilizers intended to destroy viruses and all
living bacteria, fungi, and their spores on inanimate
surfaces; or
(v) fungicides or fungistats.
(CXi) Notwithstanding any other provision of this subsec-
tion, in the case of a small business registrant of a pesti-
cide, the registrant shall pay a fee for the reregistration of
each active ingredient of the pesticide that does not exceed
an amount determined in accordance with this subpara-
graph.
(ii) If during the 3-year period prior to reregistration the
average annual gross revenue of the registrant from pesti-
cides containing such active ingredient is—
® less than $5,000,000, the registrant shall pay 0.5
percent of such revenue;
(ID $5,000,000 or more but less than $10,000,000, the
registrant shall pay 1 percent of such revenue; or
(IH) $10,000,000 or more, the registrant shall pay 1.5
percent of such revenue, but not more than $150,000.
(iii) For the purpose of this subparagraph, a small busi-
ness registrant is a corporation, partnership, or unincorpo-
rated business that—
(I) has 150 or fewer employees; and
(II) during the 3-year period prior to reregistration,
had an average annual gross revenue from chemicals
that did not exceed $40,000,000.
(5) MAINTENANCE FEE.—
(A) Subject to other provisions of this paragraph, each
registrant of a pesticide shall pay an annual fee by March
1 of each year of—
(i) in the case of a registrant holding not more than
50 pesticide registrations, $425 for each registration;
and
(ii) in the case of a registrant holding more than 50
pesticide registrations—
(I) $425 for each registration up to 50 registra-
tions; and
CD) $100 for each registration over 50 registra-
tions, except that no fee shall be charged for more
than 200 registrations held by any registrant.
(B) The amount of each fee prescribed under subpara-
graph (A) shall be adjusted by the Administrator to a level
that will result hi the collection under this paragraph of,
to the extent practicable, an aggregate amount of
$14,000,000 each fiscal year.
(CXi) The maximum annual fee payable by a registrant
under clause (i) of subparagraph (A) (as adjusted under
subparagraph (B)) shall be $20,000.
(ii) The maximum annual fee payable by a registrant
under clause (ii) of subparagraph (A) (as adjusted under
subparagraph (B)) shall be $35,000.
(D) If any fee prescribed by this paragraph with respect
to the registration of a pesticide is not paid by a registrant
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35
FIFRA
Sec. 4
by the time prescribed, the Administrator, by order and
without hearing, may cancel the registration.
(E) The authority provided under this paragraph shall
terminate on September 30,1997.
(6) OTHER FEES.—During the period beginning on the date of
enactment of this section [October 25, 1988] and ending on Sep-
tember 30, 1997, the Administrator may not levy any other
fees for the registration of a pesticide under this Act except as
provided in paragraphs (1) through (5).
(7) APPORTIONMENT.—
(A) If two or more registrants are required to pay any
fee prescribed by paragraph (1), (2), or (3) with respect to a
particular active ingredient, the fees for such active ingre-
dient shall be apportioned among such registrants on the
basis of the market share in United States sales of the
active ingredient for the 3 calendar years preceding the
date of payment of such fee, except that—
(i) small business registrants that produce the active
ingredient shall pay fees in accordance with para-
graph (4)(C); and
(ii) registrants who have no market share but who
choose to reregister a pesticide containing such active
ingredient shall pay the lesser of—
(I) 15 percent of the reregistration fee; or
(II) a proportionate amount of such fee based on
the lowest percentage market share held by any
registrant active in the marketplace.
In no event shall registrants who have no market
share but who choose to reregister a pesticide contain-
ing such active ingredient collectively pay more than
25 percent of the total active ingredient reregistration
fee.
(B) The Administrator, by order," may require any regis-
trant to submit such reports as the Administrator deter-
mines to be necessary to allow the Administrator to
determine and apportion fees under this subsection or to
determine the registrant's eligibility for a reduction or
waiver of a fee.
(C) If any such report is not submitted by a registrant
after receiving notice of such report requirement, or if any
fee prescribed by this subsection (other than paragraph (5))
for'an active ingredient is not paid by a registrant to the
Administrator by the time prescribed under this subsec-
tion, the Administrator, by order and without hearing,
may cancel each registration held by such registrant of a
pesticide containing the active ingredient with respect to
which the fee is imposed. The Administrator shall reappor-
tion the fee among the remaining registrants and notify
the registrants that the registrants are required to pay to
the Administrator any unpaid balance of the fee within 30
days after receipt of such notice.
(j) EXEMPTION OF CERTAIN REGISTRANTS.—The requirements of
subsections (d), (e), (f), and (i) (other than subsection (i)(5)) regarding
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Sec. 5
FIFRA
36
data concerning an active ingredient and fees for review of such
data shall not apply to any person who is the registrant of a pesti-
cide to the extent that, under section 3(c)(2)(D), the person would
not be required to submit or cite such data to obtain an initial reg-
istration of such pesticide.
(k) REREGISTRATION AND EXPEDITED PROCESSING FUND.—
(1) ESTABLISHMENT.—There shall be established in the Treas-
ury of the United States a reregistration and expedited proc-
essing fund.
(2) SOURCE AND USE.—All fees collected by the Administrator
under subsection (i) shall be deposited into the fund and shall
be available to the Administrator, without fiscal year limita-
tion, to carry out reregistration and expedited processing of
similar applications.
(3) EXPEDITED PROCESSING OF SIMILAR APPLICATIONS.—
(A) The Administrator shall use each fiscal year not
more than $2,000,000 of the amounts in the fund to obtain
sufficient personnel and resources to assure the expedited
processing and review of any application that—
(i) proposes the initial or amended registration of an
end-use pesticide that, if registered as proposed, would
be identical or substantially similar in composition
and labeling to a currently-registered pesticide identi-
fied in the application, or that would differ in composi-
tion and labeling from any such currently-registered
pesticide only in ways that would not significantly in-
crease the risk of unreasonable adverse effects on the
environment; or
(ii) proposes an amendment to the registration of a
registered pesticide that does not require scientific
review of data.
(B) Any amounts made available under subparagraph
(A) shall be used to obtain sufficient personnel and re-
sources to carry out the activities described in such sub-
paragraph that are in addition to the personnel and re-
sources available to carry out such activities on the date of
enactment of this section [October 25, 1988].
(4) UNUSED FUNDS.—Money in the fund not currently needed
to carry out this section shall be—
(A) maintained on hand or on deposit;
(B) invested in obligations of the United States or guar-
anteed thereby; or
(C) invested in obligations, participations, or other in-
struments that are lawful investments for fiduciary, trust,
or public funds.
(5) ACCOUNTING.—The Administrator shall—
(A) provide an annual accounting of the fees collected
and disbursed from the fund; and
(B) take all steps necessary to ensure that expenditures
from such fund are used only to carry out this section.
(1) JUDICIAL REVIEW.—Any failure of the Administrator to take
any action required by this section shall be subject to judicial
review under the procedures prescribed by section 16(b).
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37
FIFRA
Sec. 5
SEC. 5. £136c] EXPERIMENTAL USE PERMITS.
(a) ISSUANCE.;—Any person may apply to the Administrator for
an experimental use permit for a pesticide. The Administrator
shall review the application. After completion of the review, but
not later than one hundred and twenty days after receipt of the ap-
plication and all required supporting data, the Administrator shall
either issue the permit or notify the applicant of the Administra-
tor's determination not to issue the permit and the reasons there-
for. 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 informa-
tion 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 L,EVEL.^-If the Administrator deter-
mines 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 tem-
porary tolerance level for the residue of the pesticide before issuing
the experimental use permit.
(c) USE UNDER PERMIT.—Use of a pesticide under an experimen-
tal use permit shall be under the supervision of the Administrator,
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 included 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 un-
reasonable 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 experimen-
tal 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 Administrator 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 11 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.—Not-
withstanding the foregoing provisions of this section, the Adminis-
trator may issue an experimental use permit for a pesticide to any
public or private agricultural research agency or educational insti-
tution which applies for such permit. Each permit shall not exceed
more than a one-year period or such other specific time as the Ad-
ministrator may prescribe. Such permit shall be issued under such
terms and conditions restricting the use of the pesticide as the Ad-
ministrator may require. Such pesticide may be used only by such
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Sec. 6
FIFRA
38
research agency or educational institution for purposes of experi-
mentation.
SEC. 6. [136dJ ADMINISTRATIVE REVIEW; SUSPENSION.
(a) CANCELLATION AFTER FIVE YEARS—
(1) PROCEDURE.—The Administrator shall cancel the registra-
tion 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 interest-
ed 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. The Administrator may permit the continued
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 inconsist-
ent with the purposes of this Act and will not have unreason-
able adverse effects on the environment. The Administrator
shall publish in the Federal Register, at least 30 days prior to
the expiration of such five-year period, notice that the registra-
tion will be canceled if the registrant or other interested
person with the concurrence of the registrant does not request
that the registration be continued in effect.
(2) INFORMATION.—If at any time after the registration of a
pesticide the registrant has additional factual information re-
garding unreasonable adverse effects on the environment of
the pesticide, he shall submit such information to the Adminis-
trator.
(b) CANCELLATION AND CHANGE IN CLASSIFICATION.—If it appears
to the Administrator that a pesticide or its labeling or other mate-
rial required to be submitted does not comply with the provisions
of this Act or, when used in accordance with widespread and com-
monly 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 to-
gether with the reasons (including the factual basis) for his
action, or
(2) to hold a hearing to determine whether or not its regis-
tration should be canceled or its classification changed.
Such notice shall be sent to the registrant and made public. In de-
termining whether to issue any such notice, the Administrator
shall include among those 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 Agri-
culture 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 the notice and analysis within 30
days after receiving them, the Administrator shall publish in the
Federal Register (with the notice) the comments of the Secretary
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39
FIFRA
Sec. 6
and the response of the Administrator with regard to the Secre-
tary's comments. If the Secretary does not comment in writing to
the Administrator 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 Administrator and
the Secretary. Notwithstanding any other provision of this subsec-
tion (b) and section 25(d), in the event that the Administrator de-
termines that suspension of a pesticide registration is necessary to
prevent an imminent 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 Advisory Panel
pursuant to section 25(d) and proceed in accordance with subsection
(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 ad-
versely affected by the notice. In the event a hearing is held pursu-
ant to such a request. or to the Administrator's determination
under paragraph (2), a decision pertaining to registration or classi-
fication 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 restric-
tions, and shall include among those factors to be taken into ac-
count 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 re-
quired for cancellation or change in classification proceedings,
he may, by order, suspend the registration of the pesticide im-
mediately. 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
Administrator shall notify the registrant prior to issuing any
suspension order. Such notice shall include findings pertaining
to the question of "imminent hazard". The registrant shall
then have an opportunity, m accordance with the provisions of
paragraph (2), for an expedited hearing before the Administra-
tor on the question of whether an imminent hazard exists.
(2) EXPEDITE HEARING.—If no request for a hearing is submit-
ted to the Administrator within five days of the registrant's re-
ceipt of the notification provided for by paragraph (1), the sus-
pension order may be issued and shall take effect and shall not
be reviewable by a court. If a hearing is requested, it shall
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Sec. 6
FIFRA
40
commence within five days of the receipt of the request for
such hearing unless the registrant and the Administrator
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, except that the presiding offi-
cer need not be a certified hearing examiner. The presiding of-
ficer shall have ten days from the conclusion of the presenta-
tion 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 deter-
mines 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 except that (A) the order of suspen-
sion shall be in effect pending the expeditious completion of
the remedies provided by that paragraph and the issuance of a
final order on suspension, and (B) no party other than the reg-
istrant and the Administrator shall participate except that any
person adversely affected may file briefs within the time allot-
ted by the Administrator's rules. Any person so filing briefs
shall be considered a party to such proceeding for the purposes
of section 16(b).
(4) JUDICIAL REVIEW.—A final order on the question of sus-
pension following a hearing shall be reviewable in accordance
with Section 16 of this Act, notwithstanding the fact that any
related cancellation proceedings have not been completed. 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 concur-
rence of the registrant in an appropriate district court, solely
to determine whether the order of. suspension was arbitrary,
capricious or an abuse of discretion, 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 ef-
fectiveness of the suspension order, pending the Administra-
tor'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 commencement 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 requested 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 rele-
vant 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 hear-
ing, the Hearing Examiner shall issue a subpena to compel testimo-
ny or production of documents from any person. The Hearing Ex-
aminer shall be guided by the principles of the Federal Rules of
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41
FIFRA
Sec. 6
Civil Procedure in making any order for the protection of the wit-
ness or the content of documents produced and shall order the pay-
ment of reasonable fees and expenses as a condition to requiring
testimony of the witness. On contest, the subpena may be enforced
by an appropriate 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 Examiner shall at any time
before the hearing record is closed refer to a Committee of the Na-
tional Academy of Sciences the relevant questions of scientific fact
involved in the public hearing. No member of any committee of the
National Academy of Sciences established to carry out the func-
tions of this section shall have a financial or other conflict of inter-
est with respect to any matter considered by such committee. The
Committee of the National Academy 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
Administrator shall enter into appropriate arrangements with the
National Academy of Sciences to assure an objective and compe-
tent 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 pur-
poses 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 re-
ports 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, deny-
ing 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.—
(1) The Administrator shall issue a notice of intent to cancel
a registration issued under section 3(c)(7) of this Act if (A) the
Administrator, at any time during the period provided for sat-
isfaction of any condition imposed, determines that the regis-
trant has failed to initiate and pursue appropriate action
toward fulfilling any condition imposed, or (B) at the end of the
period provided for satisfaction of any condition imposed, that
condition has not been met. The Administrator may permit the
continued sale and use of existing stocks of a pesticide whose
conditional registration has been canceled under this subsec-
tion 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 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 re-
ceipt by the registrant of the notice of intent to cancel Unless
during that time a request for hearing is made by a person ad-
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Sec. 7
FIFRA
42
yersely affected by the notice. If a hearing is requested, a hear-
ing shall be conducted under subsection (d) of this section. The
only matters for resolution at that hearing 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, satis-
fied 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. Notwithstanding 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.
(f) GENERAL PROVISIONS.—
(1) VOLUNTARY CANCELLATION.—A registrant at any tune
may request that any of its pesticide registrations be canceled
or be amended to delete one or more uses. Before acting on
such request, the Administrator shall publish in the Federal
Register a notice of the receipt of the request. Thereafter, the
Administrator may approve such a request.
(2) PUBLICATION OF NOTICE.—A notice of denial of registra-
tion, intent to cancel, suspension, or intent to suspend issued
under this Act or a notice issued under subsection (cX4) or
(dXSXA) of section 4 shall be published in the Federal Register
and shall be sent by certified mail, return receipt requested, to
the registrant's or applicant's address of record on file with the
Administrator. If the mailed notice is returned to the Adminis-
trator as undeliverable at that address, if delivery is refused,
or if the Administrator otherwise is unable to accomplish deliv-
ery of the notice to the registrant or applicant after making .
reasonable efforts to do so, the notice shall be deemed to have
been received by the registrant or applicant on the date the
notice was published in the Federal Register.
(g) NOTICE FOR STORED PESTICIDES WITH CANCELED OR SUSPENDED
REGISTRATIONS.—
(1) IN GENERAL.—Any producer or exporter of pesticides, reg-
istrant of a pesticide, applicant for registration of a pesticide,
applicant for or holder of an experimental use permit, commer-
cial applicator, or any person who distributes or sells any pesti-
cide, who possesses any pesticide which has had its registration
canceled or suspended under this section shall notify the Ad-
ministrator and appropriate State and local officials of—
(A) such possession,
(B) the quantity of such pesticide such person possesses,
and
(C) the place at which such pesticide is stored.
, (2) COPIES.—The Administrator shall transmit a copy of each
notice submitted under this subsection to the regional office of
the Environmental Protection Agency which has jurisdiction
over the place of pesticide storage identified in the notice.
(h) JUDICIAL REVIEW.—Final orders of the Administrator under
this section shall be subject to judicial review pursuant to section
16.
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43
FIFRA
Sec. 8
SEC. 7. C136eJ REGISTRATION OF ESTABLISHMENTS.
(a) REQUIREMENT.—No person shall produce any pesticide subject
to this Act or active ingredient used in producing a pesticide sub-
ject to this Act in any State unless the establishment in which it is
produced is registered with the Administrator. The application for
registration of any establishment shall include the name and ad-
dress of the establishment and of the producer who operates such
establishment.
(b) REGISTRATION.—Whenever the Administrator receives an ap-
plication 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 pesti-
cides and, if applicable, active 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 cur-
rent and submitted to the Administrator annually as required
under such regulations as the Administrator may prescribe.
(2) Any such producer shall, upon the request of the Admin-
istrator for the purpose of issuing a stop sale order pursuant to
section 13, inform him of the name and address of any recipi-
ent of any pesticide produced 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 pro-
ducing pesticides produced, sold, or distributed at an establishment
shall be considered confidential and shall be subject to the provi-
sions of section 10.
SEC. 8. [1360 BOOKS AND RECORDS.
(a) REQUIREMENTS.—The Administrator may prescribe regula-
tions requiring producers, registrants, and applicants for registra-
tion to maintain such records with respect to their operations and
the pesticides and devices produced as he determines are necessary
for the effective enforcement of this Act and to make the records
available for inspection and copying in the same manner as provid-
ed in subsection (b). No records required under this subsection shall
extend to financial data, sales data other than shipment data, pric-
ing data, personnel data, and research data (other than data relat-
ing to registered pesticides or to a pesticide for which an applica-
tion for registration has been filed).
(b) INSPECTION.—For the purposes of enforcing the provisions of
this Act, any producer, distributor, carrier, dealer, or any other
person who sells or offers 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 Admin-
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Sec. 9
FIFRA
44
istrator, 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 shipment 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 information, all other
records and information relating to such delivery, movement, 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, pric-
ing data, personnel data, and research data (other than data relat-
ing to registered pesticides or to a pesticide for which an applica-
tion for registration has been filed). Before undertaking an inspec-
tion under this subsection, the officer or employee must present to
the owner, operator, or agent hi charge of the establishment or
other place where pesticides or devices are held for distribution 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 al-
ternate and sufficient reason shall be given in writing. Each such
inspection shall be commenced and completed with reasonable
promptness.
SEC. 9. [136g3 INSPECTION OF ESTABLISHMENTS, ETC.
(a) IN GENERAL.--(I) For purposes of enforcing the provisions of
this Act, officers or employees of the Environmental Protection
Agency or of any State duly designated by the Administrator are
authorized to enter at reasonable times (A) any establishment or
other place where pesticides or devices are held for distribution or
sale for the purpose of inspecting and obtaining samples of any pes-
ticides or devices, packaged, labeled, and released for shipment,
and samples of any containers or labeling for such pesticides or de-
vices, or (B) any place where there is being held any pesticide the
registration of which has been suspended or canceled for the pur-
pose of determining compliance with section 19.
(2) Before undertaking such inspection, the officers or employees
must present to the owner, operator, or agent in charge of the es-
tablishment or other place where pesticides or devices are held for
distribution or sale, appropriate credentials and a written state-
ment as to the reason for the inspection, including a statement as
to whether a violation of the law is suspected. If no violation is sus-
pected, an alternate and sufficient reason shall be given in writing.
Each such inspection shall be commenced and completed with rea-
sonable 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 upon a showing to an officer or court of competent juris-
diction that there is reason to believe that the provisions of this
Act have been violated, officers or employees duly designated by
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45
FIFRA
Sec. 10
the Administrator are empowered to obtain and to execute war-
rants authorizing—
(1) entry, inspection, and copying of records for purposes of
this section or section 8;
(2) inspection and reproduction of all records showing the
quantity, date of shipment, and the name of consignor and con-
signee 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 contain-
ing such information, all other records and information relat-
ing 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 ex-
amination of pesticides or devices shall be made in the Envi-
ronmental Protection Agency or elsewhere as the Administra-
tor may designate for the purpose of determining from such ex-
aminations 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 Adminis-
trator 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 or in writing, with regard to such contem-
plated proceedings, and if in the opinion 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 proceeding pursuant to section 14(b) or a civil pro-
ceeding under section 14(a), when the Administrator deter-
mines that such action will be sufficient to effectuate the pur-
poses of this Act.
(2) NOTICE NOT REQUIRED.—The notice of contemplated pro-
ceedings and opportunity to present views set forth in this sub-
section are not prerequisites to the institution of any prpceed-
ing by the Attorney General.
(3) WARNING NOTICES.—Nothing in this Act shall be con-
strued as requiring the Administrator to institute proceedings
for prosecution of minor violations of this Act whenever he be-
lieves that the public interest will be adequately served by a
suitable written notice of warning.
SEC. 10. E136h] PROTECTION OF TRADE SECRETS AND OTHER INFORMA-
TION.
(a) IN GENERAL.—In submitting data required by this Act, the ap-
plicant may (1) clearly mark any portions thereof which in his
opinion are trade secrets or commercial or financial information
and (2) submit such marked material separately from other materi-
al required to be submitted under this Act.
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Sec. 10
FIFRA
46
(b) DISCLOSURE.—Notwithstanding any other provision of this Act
and subject to the limitations in subsections (d) and (e) of this sec-
tion, the Administrator 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 con-
fidential, except that, when necessary to carry out the provisions of
this Act, information relating to formulas of products 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
fact issued by the Administrator.
(c) DISPUTES.—If the Administrator proposes to release for inspec-
tion information 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 Adminis-
trator shall not thereafter make available for inspection such data
until thirty days after receipt of the notice by the applicant or reg-
istrant. During this period, the applicant or registrant may insti-
tute an action in an appropriate district court for a declaratory
judgment as to whether such information is subject to protection
under subsection (b).
(d) LIMITATIONS.—
(1) All information concerning the objectives, methodology,
results, or significance of any test or experiment performed on
or with a registered or previously registered pesticide or its
separate ingredients, impurities, or degradation products, and
any information concerning the effects of such pesticide on any
organism or the behavior of such pesticide in the environment,
including, but not limited to, data on safety to fish and wild-
life, humans and other mammals, plants, animals, and soil,
and studies on persistence, translocation and fate in the envi-
ronment, and metabolism, shall be available for disclosure to
the public. The use of such data for any registration purpose
shall be governed by section 3 of this Act. This paragraph does
not authorize the disclosure of any information that—
(A) discloses manufacturing or quality control processes,
(B) discloses the details of any methods for testing, de-
tecting, or measuring the quantity of any deliberately
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 Administrator 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
inventories of a pesticide that is otherwise entitled to confiden-
tial treatment under subsection (b) of this section may be pub-
licly disclosed in connection with a public proceeding to deter-
mine whether a pesticide, or any ingredient of a pesticide,
causes unreasonable adverse effects on health or the environ-
ment, if the Administrator determines that such disclosure is
necessary in the public interest.
(3) If the Administrator proposes to disclose information de-
scribed in clause (A), (B), or (C) of paragraph (1) or in para-
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47
FIFRA
Sec. 10
graph (2) of this subsection, the Administrator shall notify by
certified mail the submitter of such information of the intent
to release such information. The Administrator may not re-
lease such information, without the submitter's consent, until
thirty days after the submitter has been furnished such notice.
Where the Administrator finds that disclosure of information
described in clause (A), (B), or (G) of paragraph (1) of this sub-
section is necessary to avoid or lessen an imminent and sub-
stantial 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 ap-
propriate. During such period the data submitter may institute
an action in an appropriate district court to enjoin or limit the
proposed disclosure. 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 dis-
closure is not required 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 informa-
tiom
(e) DISCLOSURE TO CONTRACTORS.—Information otherwise protect-
ed from disclosure to the public under subsection (b) of this section
may be disclosed to contractors with the United States and employ-
ees of such contractors if, in the opinion of the Administrator, such
disclosure is necessary for the satisfactory performance by the con-
tractor of a contract with the United States for the performance 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 respect-
ing the information as the Administrator shall by regulation pre-
scribe.
(f) PENALTY FOR DISCLOSURE BY FEDERAL EMPLOYEES.—(1) Any
office or employee of the United States or former officer or employ-
ee of the United States who, by virtue of such employment or offi-
cial position, has obtained possession of, or has access to, material
the disclosure of which is prohibited by subsection (b) of this sec-
tion, and who, knowing that disclosure of such material is prohibit-
ed 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 imprisoned 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, information reported or
otherwise obtained under this Act. Nothing in this Act shall pre-
empt any civil remedy under State or Federal law for wrongful dis-
closure of trade secrets.
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Sec. 11
FIFRA
48
(2) For the purposes of this section, any contractor with the
United States who is furnished information as authorized by sub-
section (e) of this section, or any employee of any such contractor,
shall be considered to be an employee of the United States.
(g) DISCLOSURE TO FOREIGN AND MULTINATIONAL PESTICIDE PRO-
DUCERS.—(1) The Administrator shall not knowingly disclose infor-
mation 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 regis-
trant has consented to such disclosure. The Administrator shall re-
quire an affirmation from any person who intends to inspect data
that such person does not seek access to the data for purposes 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 negli-
gently 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 regula-
tion, subject to restrictions on the availability of information con-
tained elsewhere in this Act, which information is relevant to a de-
termination by the Administrator with respect to whether a pesti-
cide, or any ingredient of a pesticide, causes unreasonable adverse
effects on health or the environment.
(2) The Administrator shall maintain records of the names of
persons to whom data are disclosed under this subsection and the
persons or organizations they represent and shall inform the appli-
cant or registrant of the names and affiliations 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.
SEC. 11. [136iJ USE OF RESTRICTED USE PESTICIDES; APPPLICATORS "-1.
(a) CERTIFICATION PROCEDURE.—
(1) FEDERAL CERTIFICATION.—In any State for which a State
plan for 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 certifi-
cation of applicators of pesticides. Such program shall conform
to the requirements imposed upon the States under the provi-
sions of subsection (a)(2) of this section and shall not require
private applicators to take any examination to establish com-
petency in the use of pesticides. Prior to the implementation of
the program, the Administrator shall publish in the Federal
Register for review and comment a summary of the Federal
plan for applicator certification and shall make generally
available within the State copies of the plan. The Administra-
tor shall hold public hearings at one 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
"•'Misspelling is so in original.
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49
FIFRA
Sec. 11
shall be held within thirty days following receipt of the request
from the Governor. In any State in which the Administrator
conducts a certification program, the Administrator may re-
quire any person engaging in the commercial application, sale,
offering for sale, holding for sale, or distribution of any pesti-
cide one or more uses of which have been classified for restrict-
ed use to maintain such records and submit such reports con-
cerning the commercial application, sale, or distribution of
such pesticide as the Administrator may be regulation pre-
scribe. Subject to paragraph (2), the Administrator shall pre-
scribe standards for the certification of applicators of pesti-
cides. Such standards shall provide that to be certified, an indi-
vidual 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 individual's
certification. The certification standard for a private applicator
shall, under .a State plan submitted for approval, be deemed
fulfilled by his completing a certification form. The Adminis-
trator shall further assure that such form contains adequate
information and affirmations to carry out the intent of this
Act, and may include in the form an affirmation that the pri-
vate applicator has completed a training program approved by
the Administrator so long as the program does not require the
private applicator to take, pursuant to a requirement pre-
scribed by the Administrator, any examination to establish
competency in the use of the pesticide. The Administrator may
require any pesticide dealer participating in a certification pro-
gram 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 submitted by any State, or any modifi-
cation thereof, if such plan in his judgment—
(A) designates a State agency as the agency responsible
for administering 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 adequate funds to the administration of the plan;
(D) provides that the State agency will make such re-
ports 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 standards 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.
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Sec. 12
FIFRA
50
(b) STATE PLANS.—If the Administrator rejects a plan submitted
under this paragraph, he shall afford the State submitting the plan
due notice and opportunity for hearing before so doing. If the Ad-
ministrator approves a plan submitted 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 appropri-
ate corrective action is not taken within a reasonable time, not to
exceed ninety days, the Administrator shall withdraw approval of
such plan.
(c) INSTRUCTION IN INTEGRATED PEST MANAGEMENT TECH-
NIQUES.—Standards prescribed by the Administrator for the certifi-
cation of applicators of pesticides under subsection (a), and the
State plans submitted to the Administrator under subsections (a)
and (b), shall include provisions for making instructional materials
concerning integrated pest management techniques available to in-
dividuals at their request in accordance with the provisions of sec-
tion 23(c) of this Act, but such plans may not require that any indi-
vidual receive instruction concerning such techniques or be shown
to be competent with respect to the use of such techniques. The Ad-
ministrator and States implementing such plans shall provide that
all interested individuals are notified of the availability of such in-
structional materials.
(d) IN GENERAL.—No regulations prescribed by the Administrator
for carrying out the provisions of this Act shall require any private
applicator to maintain any records or file any reports or other doc-
uments.
(e) SEPARATE STANDARDS.—When establishing or approving stand-
ards for licensing or certification, the Administrator shall establish
separate standards for commercial and private applicators.
SEC. 12. [136J] UNLAWFUL ACTS.
(a) IN GENERAL.—
(1) Except as provided b;
for any person in any !
person—
(A) any pesticide that is not registered under section 3 or
whose registration has been canceled or suspended, except
to the extent that distribution or sale otherwise has been
authorized by the Administrator under this Act;
(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 registration under section 3;
(C) any registered pesticide the composition of which dif-
fers at the time of its distribution or sale from its composi-
tion as described in the statement required in connection
with its registration under section 3;
(D) any pesticide which has not been colored or discol-
ored pursuant to the provisions of section 25(c)(5);
(E) any pesticide which is adulterated or misbranded; or
(F) any device which is misbranded.
subsection (b), it shall be unlawful
Itate to distribute or sell to any
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51
FIFRA
Sec. 12
(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—
(i) prepare, maintain, or submit any records re-
quired by or under section 5, 7, 8,11, or 19;
(ii) submit any reports required by or under section
5, 6, 7, 8, 11, or 19; or
(iii) allow any entry, inspection, copying of records,
or sampling authorized by this Act;
(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 author-
ized under subsection (b) may give a guaranty to the same
effect, which guaranty shall contain, in addition to his own
name and address, the name and address of the person re-
siding in the United States from whom he received the
guaranty or undertaking;
(D) to use for his own advantage or to reveal, other than
to the Administrator, or officials or employees of the Envi-
ronmental Protection 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 confiden-
tial under this Act;
(E) who is a registrant, wholesaler, dealer, retailer, or
other distributor to advertise a product registered under
this Act for restricted use without giving the classification
of the product assigned to it under section 3;
(F) to distribute or sell, or to make available for use, or
to use, any registered pesticide classified for restricted use
for some or all purposes other than in accordance with sec-
tion 3(d) and any regulations thereunder. It shall not be
unlawful to sell, under regulations issued by the Adminis-
trator, a restricted use pesticide to a person who is not a
certified applicator for application by a certified applica-
tor;
(G) to use any registered pesticide in a'manner inconsist-
ent with its labeling;
(H) to use any pesticide which is under an experimental
use permit contrary to the provisions of such permit;
(I) to violate any order issued under section 13;
(J) to violate any suspension order issued under section
3(c)(2)(B), 4, or 6;
(K) to violate any cancellation order issued under this
Act or to fail to submit a notice in accordance with section
6(g);
(L) who is a producer to violate any of the provisions of
section 7;
(M) to knowingly falsify all or part of any application for
registration, application for experimental use permit, any
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Sec. 12
FIFRA
52
information submitted to the Administrator pursuant to
section 7, any records required to be maintained pursuant
to this Act, any report filed under this Act, or any infor-
mation marked as confidential and submitted to the Ad-
ministrator 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 participate in the test. 12"2
(Q) to falsify all or part of any information relating to
the testing of any pesticide (or any ingredient, metabolite,
or degradation product thereof), including the nature of
any protocol, procedure, substance, organism, or equip-
ment used, observation made, or conclusion or opinion
formed, submitted to the Administrator, or that the person
knows will be furnished to the Administrator or will
become a part of any records^ required to be maintained by
this Act;
(R) to submit to the Administrator data known to be
false in support of a registration; or
(S) to violate any regulation issued under section 3(a) or
19.
(b) EXEMPTIONS.—The penalties provided for a violation of para-
graph (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 re-
ceived in good faith the pesticide in the same unbroken pack-
age, 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 guar-
antor 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 de-
livering 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 official 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
wlSo in original, "or" should be struck.
'"So in original. Period should be a semicolon.
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53
FIFRA
Sec. 13
(5) any person who ships a substance or mixture of sub-
stances 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 control from its use.
SEC. 13. [136k] 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 provisions 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 registration of
the pesticide has been canceled by a final order or has, been^ sus-
pended, 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 provisions 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 country, shall be liable to be proceeded
against in any district court in the district where it is found and
seized for confiscation by a process in rem for condemnation if—
(1) in the case of a pesticide—
(A) it is adulterated or misbranded;
(B) it is not registered pursuant to the provisions of sec-
tion 3; ,
(C) its labeling fails to bear the information required by
this Act;
(D) it is not colored or discolored and such coloring or
discoloring 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 hi 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 accord-
ance with the requirements imposed under this Act and as di-
rected by the labeling, it nevertheless causes unreasonable ad-
verse effects on the environment.
In the case of a plant regulator, defoliant, or desiccant, used in ac-
cordance 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 condemned 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 riot be sold contrary
to the provisions of this Act or the laws of the jurisdiction in which
it is sold. On payment of the costs of the condemnation proceedings
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Sec. 14
FIFRA
54
and the execution and delivery of a good and sufficient bond condi-
tioned 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
jurisdiction 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
groceedings shall be at the suit of and in the name of the United
tates.
(d) COURT COSTS, ETC.—When a decree of condemnation is en-
tered against the pesticide or device, court costs and fees, storage,
and other proper expenses shall be awarded against the person, if
any, intervening as claimant of the pesticide or device.
SEC. 14. [1361] PENALTIES.
(a) CIVIL PENALTIES.—
(1) 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 Ad-
ministrator 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 provi-
sion of this Act subsequent to receiving a written warning
from the Administrator or following a citation for a prior viola-
tion, may be assessed a civil penalty by the Administrator of
not more than $1,000 for each offense: Provided, That any ap-
plicator not included under paragraph (1) of this subsection
who holds or applies registered pesticides, or use dilutions of
registered pesticides, only to provide a service of controlling
pests without delivering any unapplied pesticide to any person
so served, and who violates any provision of this Act may be
assessed a civil penalty by the Administrator of not more than
$500 for the first offense nor more than $1,000 for each subse-
quent offense.
(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 incorpo-
rated city of the residence of the person charged.
(4) DETERMINATION OF PENALTY.—In determining the amount
of the penalty, the Administrator shall consider the appropri-
ateness of such penalty to the size of the business of the person
charged, the effect on the person's ability to continue in busi-
ness, and the gravity of the violation. Whenever the Adminis-
trator finds that the violation occurred despite the exercise of
due care or did not cause significant harm to health or the en-
vironment, 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 Administrator shall refer the matter to the At-
torney General, who shall recover such amount by action in
the appropriate United States district court.
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55
FIFRA
Sec. 15
(b) CRIMINAL PENALTIES.—
(1) IN GENERAL.—
(A) Any registrant, applicant for a registration, or pro-
ducer who knowingly violates any provision of this Act
shall be fined not more than $50,000 or imprisoned for not
more than 1 year, or both.
(B) Any commercial applicator of a restricted use pesti-
cide, or any other person not described in subparagraph
(A) who distributes or sells pesticides or devices, who
knowingly violates any provision of this Act shall be fined
not more than $25,000 or imprisoned for not more than 1
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 impris-
oned 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 for-
mulas of products acquired 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 en-
forcing 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 person as well as that of the person
employed.
SEC. 15. INDEMNITIES.
(a) GENERAL INDEMNIFICATION.—
(1) IN GENERAL.—Except as otherwise provided in this sec-
tion, if—
(A) the Administrator notifies a registrant under section
6(c)(l) that the Administrator intends to suspend a regis-
tration or that an emergency order of suspension of a reg-
istration under section 6(c)(3) has been issued;
(B) the registration in question is suspended under
section 6(c), and thereafter is canceled under section 6(b),
6(d), or 6(f); and
(C) any person who owned any quantity of the pesticide
immediately before the notice to the registrant under sub-
paragraph (A) suffered losses by reason of suspension or
cancellation of the registration;
the Administrator shall make an indemnity payment to the
person.
(2) EXCEPTION.—Paragraph (1) shall not apply if the Adminis-
trator finds that the person—
(A) had knowledge of facts that, in themselves, would
have shown that the pesticide did not meet the require-
ments of section 3(c)(5) for registration; and
(B) continued thereafter to produce the pesticide without
giving timely notice of such facts to the Administrator.
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Sec. 15
FIFRA
56
(3) REPORT.—If the Administrator takes an action under
, paragraph (1) that requires the payment of indemnification,
the Administrator shall report to the Committee on Agricul-
ture of the House of Representatives, the Committee on Agri-
culture, Nutrition, and Forestry of the Senate, and the Com-
mittees on Appropriations of the House of Representatives and
the Senate on—
(A) the action taken that requires the payment of
indemnification;
(B) the reasons for taking the action;
(C) the estimated cost of the payment; and
(D) a request for the appropriation of funds for the pay-
ment.
(4) APPROPRIATION.—The Administrator may not make a pay-
ment of indemnification under paragraph (1) unless a specific
line item appropriation of funds has been made in advance for
the payment.
(b) INDEMNIFICATION OF END USERS, DEALERS, AND DISTRIBU-
TORS.—
(1) END USERS.—If—
(A) the Administrator notifies a registrant under section
6(c)(l) that the Administrator intends to suspend a regis-
tration or that an emergency order of suspension of a reg-
istration under section 6(c)(3) has been issued;
(B) the registration in question is suspended under sec-
tion 6(c), and thereafter is canceled under section 6(b), 6(d),
or 6(f); and
(C) any person who, immediately before the notice to the
registrant under subparagraph (A), owned any quantity of
the pesticide for purposes of applying or using the pesti-
cide as an end user, rather than for purposes of distribut-
ing or selling it or further processing it for distribution or
sale, suffered a loss by reason of the suspension or cancel-
lation of the pesticide;
the person shall be entitled to an indemnity payment under
this subsection for such quantity of the pesticide.
(2) DEALERS AND DISTRIBUTORS.—
(A) Any registrant, wholesaler, dealer, or other distribu-
tor (hereinafter in this paragraph referred to as a "seller")
of a registered pesticide who distributes or sells the pesti-
cide directly to any person not described as an end user in
paragraph (1)(C) shall, with respect to any quantity of the
pesticide that such person cannot use or resell as a result
of the suspension or cancellation of the pesticide, reim-
burse such person for the cost of first acquiring the pesti-
cide from the seller (other than the cost of transportation,
if any), unless the seller provided to the person at the time
of distribution or sale a notice, in writing, that the pesti-
cide is not subject to reimbursement by the seller.
(B)If-
(i) the Administrator notifies a registrant under sec-
tion 6(cXD that the Administrator intends to suspend
a registration or that an emergency order of suspen-
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57
FIFRA
Sec. 15
sion of a registration under section 6(c)(3) has been
issued;
(ii) the registration in question is suspended under
section 6(c), and thereafter is canceled under section
6(b), 6(d), or 6(f);
(iii) any person who, immediately before the notice
to the registrant under clause (i)—
(I) had not been notified in writing by the seller,
as provided under subparagraph (A), that any
quantity of the pesticide owned by such person is
not subject to reimbursement by the seller in the
event of suspension or cancellation of the pesti-
cide; and
(II) owned any quantity of the pesticide for pur-
poses of—
(aa) distributing or selling it; or
(bb) further processing it for distribution or
sale directly to an end user;
suffered a loss by reason of the suspension or cancella-
tion of the pesticide; and
(iv) the Administrator determines on the basis of a
claim of loss submitted to the Administrator by the
person, that the seller—
(I) did not provide the notice specified in sub-
paragraph (A) to such person; and
(II) is and will continue to be .unable to provide
reimbursement to such person, as provided under
subparagraph (A), for the loss referred to in clause
(iii), as a result of the insolvency or bankruptcy of
the seller and the seller's resulting inability to
provide such reimbursement;
the person shall be entitled to an indemnity payment
under this subsection for such quantity of the pesticide.
(C) If an indemnity payment is made by the United
States under this paragraph, the United States shall be
subrogated to any right that would otherwise be held
under this paragraph by a seller who is unable to make a
reimbursement in accordance with this paragraph with
regard to reimbursements that otherwise would have been
made by the seller.
(3) SOURCE.—Any payment required to be made under para-
graph (1) or (2) shall be made from the appropriation provided
under section 1304 of title 31, United States Code.
(4) ADMINISTRATIVE SETTLEMENT.—An administrative settle-
ment of a claim for such indemnity may be made in accord-
ance with the third paragraph of section 2414 of title 28,
United States Code, and shall be regarded as if it were made
under that section for purposes of section 1304 of title 31,
United States Code.
(c) AMOUNT OF PAYMENT.—
(1) IN GENERAL.—The amount of an indemnity payment
under subsection (a) or (b) to any person shall be determined
on the basis of the cost of the pesticide owned by the person
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58
(other than the cost of transportation, if any) immediately
before the issuance of the notice to the registrant referred to in
subsection (aXDCA), (bXD(A), or (b)(2)(B)(i), except that in no
event shall an indemnity payment to any person exceed the
fair market value of the pesticide owned by the person immedi-
ately before the issuance of the notice.
(2) SPECIAL RULE.—Notwithstanding any other provision of
this Act, the Administrator may provide a reasonable time for
use or other disposal of the pesticide. In determining the quan-
tity of any pesticide for which indemnity shall be paid under
this section, proper adjustment shall be made for any pesticide
used or otherwise disposed of by the owner.
SEC. 16. [136n3 ADMINISTRATIVE PROCEDURE; JUDICIAL REVIEW.
(a) DISTRICT COURT REVIEW.—Except as otherwise provided in
this Act, the refusal of the Administrator to cancel or suspend a
registration or to change a classification not following a hearing
and other final actions of the Administrator not committed to the
discretion of the Administrator by law are judicially reviewable by
the district courts of the United States.
(b) REVIEW BY COURT OF APPEALS.—In the case of actual contro-
versy as to the validity of any order issued by the Administrator
following a public hearing, any person who will be adversely affect-
ed by such order and who had been a party to the proceedings may
obtain judicial review by filing in the United States court of ap-
peals for the circuit wherein such person resides or has a place of
business, within 60 days after the entry of such order, a petition
praying 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 pur-
pose, 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 filing of
such petition the court shall have exclusive jurisdiction to affirm or
set aside the order complained of in whole or in part. The court
shall consider all evidence of record. The order of the Administra-
tor 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 com-
mencement of proceedings under this section shall not, unless spe-
cifically ordered by the court to the contrary, operate as a stay of
an order.
(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 publica-
tion in such manner as he may prescribe, give notice of all judg-
ments entered in actions instituted under the authority of this Act.
SEC. 17. E136oJ IMPORTS AND EXPORTS.
(a) PESTICIDES AND DEVICES INTENDED FOR EXPORT.—Notwith-
standing any other provision this Act, no pesticide or device or
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59
FIFRA
Sec. 17
active ingredient used in 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 pro-
ducing pesticides shall be subject to sections 2(p), 2(q) (1) (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 regis-
tered under section 3 or sold under section 6(a) (1) of this Act,
if, prior to export, the foreign purchaser has signed a state-
ment 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 GOVERN-
MENTS.—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 De-
partment notification thereof to the governments of other countries
and to appropriate international agencies. Such notification shall,
upon request, include all information related to the cancellation or
suspension of the registration of the pesticide and information con-
cerning other pesticides 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 pesti-
cides 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 in-
troduce testimony. If it appears from the examination of a sample
that it is adulterated, or misbranded or otherwise violates the pro-
visions set forth in this Act, or is otherwise injurious to health or
the environment, the pesticide or device may be refused admission,
and the Secretary of the Treasury shall- refuse delivery to the con-
signee and shall cause the destruction of any pesticide or device re-
fused delivery which shall not be exported by the consignee within
90 days from the date of notice of such refusal under such regula-
tions as the Secretary of the Treasury may prescribe. The Secre-
tary of the Treasury may deliver to the consignee such pesticide or
device pending examination and decision in the matter on execu-
tion of bond for the amount of. the full invoice value of such pesti-
cide 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 ex-
cluding them from the country, or for any other purpose, said cpn-
signee shall forfeit the full amount of said bond. All charges for
storage, cartage, and labor on pesticides or devices which are re-
fused admission or delivery shall be paid by the owner or consign-
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Sec. 18
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60
ee, 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 inter-
national efforts to develop improved pesticide research and regula-
tions.
(e) REGULATIONS.—The Secretary of the Treasury, in consultation
with the Administrator, shall prescribe regulations for the enforce-
ment of subsection (c) of this section.
SEC. 18. [136p] EXEMPTION OF FEDERAL AND STATE AGENCIES.
The Administrator may, at his discretion, exempt any Federal or
State agency from any provision of this Act if he determines that
emergency conditions exist which require such exemption. The Ad-
ministrator, in determining whether or not such emergency condi-
tions exist, shall consult with the Secretary of Agriculture and the
Governor of any State concerned if they request such determina-
tion.
SEC. 19. t!36ql STORAGE, DISPOSAL, TRANSPORTATION, AND RECALL.
(a) STORAGE, DISPOSAL, AND TRANSPORTATION.—
(1) DATA REQUIREMENTS AND REGISTRATION OF PESTICIDES.—
The Administrator may require under section 3 or 6 that—
(A) the registrant or applicant for registration of a pesti-
cide submit or cite data or information regarding methods
for the safe storage and disposal of excess quantities of the
pesticide to support the registration or continued registra-
tion of a pesticide;
(B) the labeling of a pesticide contain requirements and
procedures for the transportation, storage, and disposal of
the pesticide, any container of the pesticide, any rinsate
containing the pesticide, or any other material used to con-
tain or collect excess or spilled quantities of the pesticide;
and
(C) the registrant of a pesticide provide evidence of suffi-
cient financial and other resources to carry out a recall
plan under subsection (b), and provide for the disposition
of the pesticide, in the event of suspension and cancella-
tion of the pesticide.
(2) PESTICIDES.—The Administrator may by regulation, or as
part of an order issued under section 6 or an amendment to
such an order—
(A) issue requirements and procedures to be followed by
any person who stores or transports a pesticide the regis-
tration of which has been suspended or canceled;
(B) issue requirements and procedures to be followed by
any person who disposes of stocks of a pesticide the regis-
tration of which has been suspended; and
(C) issue requirements and procedures for the disposal of
any pesticide the registration of which has been canceled.
(3) CONTAINERS, RINSATES, AND OTHER MATERIALS.—The Ad-
ministrator may by regulation, or as part of an order issued
under section 6 or an amendment to such an order—
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FIFRA
Sec. 19
(A) issue requirements and procedures to be followed by
any person who stores or transports any container of a
pesticide the registration of which has been suspended or
canceled, any rinsate containing the pesticide, or any other
material used to contain or collect excess or spilled quanti-
ties of the pesticide;
(B) issue requirements and procedures to be followed by
any person who disposes of stocks of any container of a
pesticide the registration of which has been suspended,
any rinsate containing the pesticide, or any other material
used to contain or collect excess or spilled quantities of the
pesticide; and
(C) issue requirements and procedures for the disposal of
any container of a pesticide the registration of which has
been canceled, any rinsate containing the pesticide, or any
other material used to contain or collect excess or spilled
quantities of the pesticide.
(b) RECALLS.—
(1) IN GENERAL.—If the registration of a pesticide has been
suspended and canceled under section 6, and if the Administra-
tor finds that recall of the pesticide is necessary to protect
health or the environment, the Administrator shall order a
recall of the pesticide in accordance with this subsection.
(2) VOLUNTARY RECALL.—If, after determining under para-
i graph (1) that a recall is necessary, the Administrator finds
that voluntary recall by the registrant and others in the chain
of distribution may be as safe and effective as a mandatory
recall, the Administrator shall request the registrant of the
pesticide to submit, within 60 days of the request, a plan for
the voluntary recall of the pesticide. If such a plan is requested
and submitted, the Administrator shall approve the plan and
order the registrant to conduct the recall in accordance with
the plan unless the Administrator determines, after an infor-
mal hearing, that the plan is inadequate to protect health or
the environment.
(3) MANDATORY RECALL.—If, after determining under para-
graph (1) that a recall is necessary, the Administrator does not
request the submission of a plan under paragraph (2) or finds
such a plan to be inadequate, the Administrator shall issue a
regulation that prescribes a plan for the recall of the pesticide.
A regulation issued under this paragraph may apply to any
person who is or was a registrant, distributor, or seller of the
pesticide, or any successor in interest to such a person.
(4) RECALL PROCEDURE.—A regulation issued under this sub-
section may require any person that is subject to the regula-
tion to—
(A) arrange to make available one or more storage facili-
ties to receive and store the pesticide to which the recall
program applies, and inform the Administrator of the loca-
tion of each such facility;
(B) accept and store at such a facility those existing
stocks of such pesticide that are tendered by any other
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Sec. 19
FIFRA
62
person who obtained the pesticide directly or indirectly
from the person that is subject to such regulation;
(C) on the request of a person making such a tender, pro-
vide for proper transportation of the pesticide to a storage
facility; and
(D) take such reasonable steps as the regulation may
prescribe to inform persons who may be holders of the pes-
ticide of the terms of the recall regulation and how those
persons may tender the pesticide and arrange for transpor-
tation of the pesticide to a storage facility.
(5) CONTENTS OF RECALL PLAN.—A recall plan established
under this subsection shall include—
(A) the level in the distribution chain to which the recall
is to extend, and a schedule for recall; and
(B) the means to be used to verify the effectiveness of
the recall.
(6) REQUIREMENTS OR PROCEDURES.—No requirement or proce-
dure imposed in accordance with paragraph (2) of subsection
(a) may require the recall of existing stocks of the pesticide
except as provided by this subsection.
(c) STORAGE COSTS.—
(1) SUBMISSION OF PLAN.—A registrant who wishes to become
eligible for reimbursement of storage costs incurred as a result
of a recall prescribed under subsection (b) for a pesticide whose
registration has been suspended and canceled shall, as soon as
practicable after the suspension of the registration of the pesti-
cide, submit to the Administrator a plan for the storage and
disposal of the pesticide that meets criteria established by the
Administrator by regulation.
(2) REIMBURSEMENT.—Within a reasonable period of time
after such storage costs are incurred and paid by the regis-
trant, the Administrator shall reimburse the registrant, on re-
quest, for—
(A) none of the costs incurred by the registrant before
the date of submission of the plan referred to in paragraph
(1) to the Administrator;
(B) 100 percent of the costs incurred by the registrant
after the date of submission of the plan to the Administra-
tor or the date of cancellation of the registration of the
pesticide, whichever is later, but before the approval of the
plan by the Administrator;
(C) 50 percent of the costs incurred by the registrant
during the 1-year period beginning on the date of the ap-
proval of the plan by the Administrator or the date of can-
cellation of the registration of the pesticide, whichever is
later;
(D) none of the costs incurred by the registrant during
the 3-year period beginning on the 366th day following ap-
proval of the plan by the Administrator or the date of can-
cellation of the registration of the pesticide, whichever is
later; and
(E) 25 percent of the costs incurred by the registrant
during the period beginning on the first day of the 5th
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FIFRA
Sec. 19
year following the date of the approval of the plan by the
Administrator or the date of cancellation of the registra-
tion of the pesticide, whichever is later, and ending on the
date that a disposal permit for the pesticide is issued by a
State or an alternative plan for disposal of the pesticide in
accordance with applicable law has been developed.
(d) ADMINISTRATION OF STORAGE, DISPOSAL, TRANSPORTATION, AND
•RECALL PROGRAMS.—
(1) VOLUNTARY AGREEMENTS.—Nothing in this section shall
be construed as preventing or making unlawful any agreement
between a seller and a buyer of any pesticide or other sub-
stance regarding the ultimate allocation of the costs of storage,
transportation, or disposal of a pesticide.
(2) RULE AND REGULATION REVIEW.—Section 25(a)(4) shall not
apply to any regulation issued under subsection (a)(2) or (b).
(3) LIMITATIONS.—No registrant shall be responsible under
this section for a pesticide the registration of which is held by
another person. No distributor or seller shall be responsible
under this section for a pesticide that the distributor or seller
did not hold or sell. ,
(4) SEIZURE AND PENALTIES.—If the Administrator finds that
a person who is subject to a regulation or order under subsec-
tion (a)(2) or (b) has failed substantially to comply with that
regulation or order, the Administrator may take action under
section 13 or 14 or obtain injunctive relief under section 16(c)
against such person or any successor in interest of any such
person.
(e) CONTAINER DESIGN.—
(1) PROCEDURES.—
(A) Not later than 3 years after the effective date of this
subsection [December 24, 1988], the Administrator shall, in
consultation with the heads of other interested Federal
agencies, promulgate regulations for the design of pesticide
containers that will promote the safe storage and disposal
of pesticides.
(B) The regulations shall ensure, to the fullest extent
practicable, that the containers—
(i) accommodate procedures used for the removal of
pesticides from the containers and the rinsing of the
containers;
(ii) facilitate the safe use of the containers, including
elimination of splash and leakage of pesticides from
the containers;
(iii) facilitate the safe disposal of the containers; and
(iv) facilitate the safe refill and reuse of the
containers.
(2) COMPLIANCE.—The Administrator shall require compli-
ance with the regulations referred to in paragraph (1) not later
than 5 years after the effective date of this subsection [Decem-
ber 24, 1988]. ,
(f) PESTICIDE RESHJUE REMOVAL.—
(1) PROCEDURES.—
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Sec. 19
FIFRA
64
(A) Not later than 3 years after the effective date of this
subsection [December 24, 1988], the Administrator shall, in
consultation with the heads of other interested Federal
agencies, promulgate regulations prescribing procedures
and standards for the removal of pesticides from contain-
ers prior to disposal.
(B) The regulations may—
(i) specify, for each major type of pesticide container/
procedures and standards providing for, at a mini-
mum, triple rinsing or the equivalent degree of pesti-
cide removal;
(ii) specify procedures that can be implemented
promptly and easily in various circumstances and con-
ditions;
(iii) provide for reuse, whenever practicable, or
disposal of rinse water and residue; and
(iv) be coordinated with requirements for the rinsing
of containers imposed under the Solid Waste Disposal
Act (42 U.S.C. 6901 et seq.).
(C) The Administrator may, at the discretion of the Ad-
ministrator, exempt products intended solely for household
use from the requirements of this subsection.
(2) COMPLIANCE.—Effective beginning 5 years after the effec-
tive date of this subsection [December 24, 1988], a State may
not exercise primary enforcement responsibility under section
26, or certify an applicator under section 11, unless the Admin-
istrator determines that the State is carrying out an adequate
program to ensure compliance with this subsection.
(3) SOLID WASTE DISPOSAL ACT.—Nothing in this subsection
shall affect the authorities or requirements concerning pesti-
cide containers under the Solid Waste Disposal Act (42 U.S.C.
6901).
(g) PESTICIDE CONTAINER STUDY.—
(1) STUDY.—
(A) The Administrator shall conduct a study of options
to encourage or require—
(i) the return, refill, and reuse of pesticide con-
tainers;
(ii) the development and use of pesticide formula-
tions that facilitate the removal of pesticide residues
from containers; and
(iii) the use of bulk storage facilities to reduce the
number of pesticide containers requiring disposal.
(B) In conducting the study, the Administrator shall—
(i) consult with the heads of other interested Federal
agencies, State agencies, industry groups, and environ-
mental organizations; and
(ii) assess the feasibility, costs, and environmental
benefits of encouraging or requiring various measures
or actions.
(2) REPORT.—Not later than 2 years after the effective date of
this subsection [December 24, 1988], the Administrator shall
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65
FIFRA
Sec. 21
submit to Congress a report describing the results of the study
required under paragraph (1).
(h) RELATIONSHIP TO SOLID WASTE DISPOSAL ACT.—Nothing in this
section shall diminish the authorities or requirements of the Solid
Waste Disposal Act (42 U.S.C. 6901 et seq.).
SEC. 20. [136rJ RESEARCH AND MONITORING.
(a) RESEARCH.—The Administrator shall undertake research, in-
cluding research by grant or contract with other Federal agencies,
universities, or others as may be necessary to carry out the pur-
poses of this Act, and he shall conduct research into integrated
pest management in coordination with the Secretary of Agricul-
ture. The Administrator shall also take care to insure that such re-
search does not duplicate research being undertaken by any other
Federal agency.
(b) NATIONAL MONITORING PLAN.—The Administrator shall for-
mulate 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 moni-
toring activities, 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 monitor-
ing plan. The Administrator shall establish procedures for the
monitoring of man and animals and their environment for inciden-
tal pesticide exposure, including, but not limited to, the quantifica-
tion 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.
SEC. 21. rises! SOLICITATION OF COMMENTS; NOTICE OF PUBLIC HEAR-
INGS.
(a) SECRETARY OF AGRICULTURE.—The Administrator, before pub-
lishing regulations under this Act, shall solicit the views of the Sec-
retary of Agriculture in accordance with the procedure described in
section 25(a).
(b) VIEWS.—In addition to any other authority relating to public
hearings and solicitation of views, in connection with the suspen-
sion or cancellation of a pesticide registration or any other actions
authorized under this Act, the Administrator may, at his discre-
tion, solicit the views of all interested persons, either orally or in
writing, and seek such advice from scientists, farmers, farm organi-
zations, and other qualified persons as he deems proper.
(c) NOTICE.—In connection with all public hearings under this
Act the Administrator shall publish timely notice of such hearings
in the Federal Register.
SEC. 22. [136t3 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
Department of Agriculture, any other Federal agency, and any ap-
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Sec. 23
FIFRA
66
propriate agency of any State or any political subdivision thereof,
in carrying out the provisions of this Act, and in securing uniformi-
ty of regulations.
SEC. 23. [136u3 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 enforce-
ment programs through grants-in-aid; and
(2) to assist States in developing and administering State pro-
grams, and Indian tribes that enter into cooperative agree-
ments, to train and certify applicators consistent with the
standards the Administrator prescribes.
Effective with the fiscal year beginning October 1, 1978, there are
authorized to be appropriated annually such funds as may be nec-
essary for the Administrator to provide through cooperative agree-
ments 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 programs
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 into contracts with Federal, State, or Indian tribal agen-
cies for the purpose of encouraging the training of certified applica-
tors.
(c) INFORMATION AND EDUCATION.—The Administrator shall, in
cooperation with the Secretary of Agriculture, use the services of
the cooperative State extension services to inform and educate pes-
ticide users about accepted uses and other regulations made under
this Act.
SEC. 24. [136v3 AUTHORITY OF STATES.
(a) IN GENERAL.—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 prohib-
ited by this Act.
(b) UNIFORMITY.—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) ADDITIONAL USES.—
(1) 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, disapproved, or canceled by the Admin-
istrator. Such registration shall be deemed registration under
section 3 for all purposes of this Act, but shall authorize distri-
bution and use only within such State.
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Sec. 25
(2) A registration issued by a State under this subsection
shall not be effective for more than ninety days if disapproved
by the Administrator within that period. Prior to disapproval,
the Administrator shall, except as provided in paragraph (3) of
this subsection, advise the State of the Administrators inten-
tion 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 subsec-
tion (A) on the basis of lack of essentiality of a pesticide or (B)
except 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 res-
idues 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 constitutes 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 registration under this section will be in accord with
the purposes of this Act or has failed to exercise adequate con-
trols, the Administrator may suspend the authority of the
State to register pesticides runtil such time as the Administra-
tor is satisfied that the State can and will exercise adequate
controls. 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 re-
spond.
SEC. 25. [136w] AUTHORITY OF ADMINISTRATOR.
(a) IN GENERAL.—
(1) REGULATIONS.—The Administrator is authorized in ac-
cordance with the procedure described in paragraph (2), to pre-
scribe regulations to carry out the provisions of this Act. Such
regulations shall take into account 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 Fed-
eral Register, the Administrator shall provide the Secre-
tary of Agriculture with a copy of such regulation. If the
Secretary comments in writing to the Administrator re-
garding any such regulation within 30 days after receiving
it, the Administrator shall publish in the Federal Register
(with the proposed regulation) the comments of the Secre-
tary and the response of the Administrator with regard to
the Secretary's comments. If the Secretary does not com-
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Sec. 25
FIFRA
68
ment in writing to the Administrator regarding the regula-
tion 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 notwithstand-
ing the foregoing 60-day time requirement.
(B) FINAL REGULATIONS.—At least 30 days prior to sign-
ing any regulation in final form for publication in the Fed-
eral Register, the Administrator shall provide the Secre-
tary of Agriculture with a copy of such regulation. If the
Secretary comments in writing to the Administrator re-
garding any such final regulation within 15 days after re-
ceiving it, the Administrator shall publish in the Federal
Register (with the final regulation) the comments of the
Secretary, if requested by the Secretary, and the response
of the Administrator concerning the Secretary's comments.
If the Secretary does not comment in writing to the Ad-
ministrator 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
tune requirement. In taking any final action under this
subsection, the Administrator shall include among those
factors to be taken into account the effect of the regulation
on production and prices of agricultural commodities,
retail food prices, and otherwise on the agricultural econo-
my, and the Administrator shall publish in the Federal
Register an analysis of such effect.
(C) TIME REQUIREMENTS.—The time requirements im-
posed 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 Admin-
istrator shall, simultaneously with any notification to the
Secretary of Agriculture under this paragraph prior to the
issuance of any proposed or final regulation, publish such
notification hi the Federal Register.
(3) CONGRESSIONAL COMMITTEES.—At such time as the Admin-
istrator 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 Representatives and the Commit-
tee on Agriculture, Nutrition, and Forestry of the Senate.
(4) CONGRESSIONAL REVIEW OF REGULATIONS.—Simultaneously
with the promulgation of any rule or regulation under this
Act, the Administrator shall transmit a copy thereof to the
Secretary of the Senate and the Clerk of the House of Repre-
sentatives. The rule or regulation shall not become effective
until the passage of 60 calendar days after the rule or regula-
tion is so transmitted.
(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 an-
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69
FIFRA
Sec. 25
other Federal agency, or (2) to be of a character which is unneces-
sary to be subject to this Act in order to carry out the purposes of
this Act.
(c) OTHER AUTHORITY.—The Administrator, after notice and op-
portunity 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-orga-
nisms on or in living man or other living animals) which is in-
jurious to health or the environment;
(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 established under the authority of the Poison Prevention
Packaging Act (Public Law 91-601)) with respect to the pack-
age, container, or wrapping 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 acci-
dental 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 provision of paragraph 2(q)(l) or section 7 of this Act upon
his determination that application of such provision is neces-
sary to effectuate the purposes of this Act;
(5) to prescribe regulations requiring any pesticide to be col-
ored 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 ingredient statement.
(d) SCIENTIFIC ADVISORY PANEL.—The Administrator shall submit
to an advisory panel for comment as to the impact on health and
the environment of the action proposed in notices of intent issued
under section 6(b) and of the proposed and final form of regulations
issued under section 25(a) within the same time periods as provided
for the comments of the Secretary of Agriculture under such sec-
tions. 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 modi-
fication or waiver. The Administrator shall also solicit from the ad-
visory panel comments, evaluations, and recommendations for op-
erating guidelines to improve the effectiveness and quality of scien-
tific analyses made by personnel of the Environmental Protection
Agency that lead to decisions by the Administrator in carrying out
the provisions of this Act. The comments, evaluations, and recom-
mendations of the advisory panel submitted under this subsection
and the response of the Administrator 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 sections.
The chairman of the advisory panel, after consultation with the
Administrator, may create temporary subpanels on specific projects
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Sec. 25
FIFRA
70
to assist the full advisory panel in expediting and preparing its
evaluations, comments, and recommendations. The subpanels may
be composed of scientists other than members of the advisory
panel, as deemed necessary for the purpose of evaluating scientific
studies relied upon by the Administrator with respect to proposed
action. Such additional scientists shall be selected by the advisory
panel. The panel referred to in this subsection shall consist of 7
members appointed by the Administrator from a list of 12 nomi-
nees, 6 nominated by the National Institutes of Health and 6 by
the National Science Foundation, utilizing a system of staggered
terms of appointment. Members of the panel shall be selected on
the basis of their professional qualifications to assess the effects of
the impact of pesticides on health and the environment. To the
extent feasible to insure multidisciplinary representation, the
panel membership shall include representation from the disciplines
of toxicology, pathology, environmental biology, and related sci-
ences. If a vacancy occurs on the panel due to expiration of a term,
resignation, or any other reason, each replacement shall be select-
ed by the Administrator from a group of 4 nominees, 2 submitted
by each of the nominating entities named in this subsection. The
Administrator may extend the term of a panel member until the
new member is appointed to fill the vacancy. If a vacancy occurs
due to resignation, or reason other than expiration of a term, the
Administrator shall appoint a member to serve during the unex-
pired term utilizing the nomination process set forth in this subsec-
tion. Should the list of nominees provided under this subsection be
unsatisfactory, the Administrator may request an additional set of
nominees from the nominating entities. The Administrator may re-
quire such information from the nominees to the advisory panel as
he deems necessary, and he shall publish 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 rate not in excess of that fixed for GS-18 of the General Schedule
as may be determined by the Administrator, except that any such
member who holds another office or position under the Federal
Government the compensation for which exceeds such rate may
elect to receive compensation at the rate provided for such other
office or position in lieu of the compensation provided by this sub-
section. In order to assure the objectivity of the advisory panel, the
Administrator shall promulgate regulations regarding conflicts of
interest with respect to the members of the panel. The advisory
panel established under this section shall be permanent. In per-
forming the functions assigned by this Act, the panel shall consult
and coordinate its activities with the Science Advisory Board estab-
lished under the Environmental Research, Development, and Dem-
onstration Authorization Act of 1978. Whenever the Administrator
exercises authority under section 6(c) of this Act to immediately
suspend the registration of any pesticide to prevent an imminent
hazard, the Administrator shall promptly submit to the advisory
panel for comment, as to the impact on health and the environ-
ment, the action taken to suspend the registration of such pesti-
cide.
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FIFRA
Sec. 26
(e) PEER REVIEW.—The Administrator shall, by written proce-
dures, provide for peer review with respect to the design, protocols,
and conduct of major scientific studies conducted under this Act by
the Environmental Protection Agency or by any other Federal
agency, any State or political subdivision thereof, or any institution
or individual under grant, contract, or cooperative agreement from
or with the Environmental Protection Agency. In such procedures,
the Administrator shall also provide for peer review, using the ad-
visory panel established under subsection (d) of this section or ap-
propriate experts appointed by the Administrator from a current
list of nominees maintained by such panel, with respect to the re-
sults of any such scientific studies relied upon by the Administra-
tor with respect to actions the Administrator may take relating to
the change in classification, suspension, or cancellation of a pesti-
cide. Whenever the Administrator determines that circumstances
do not permit the peer review of the results of any such scientific
study prior to the Administrator's exercising authority under sec-
tion 6(c) of this Act to immediately suspend the registration of any
pesticide to prevent an imminent hazard, the Administrator shall
promptly thereafter provide for the conduct of peer review as pro-
vided in this sentence. The evaluations and relevant documentation
constituting the peer review that relate to the proposed scientific
studies and the results of the completed scientific studies shall be
included in the submission for comment forwarded by the Adminis-
trator to the advisory panel as provided hi subsection (d). As used
in this subsection, the term "peer review" shall mean an independ-
ent evaluation by scientific experts, either within or outside the
Environmental Protection Agency, in the appropriate disciplines.
SEC. 26. £136w-l] STATE PRIMARY ENFORCEMENT RESPONSIBILITY.
(a) IN GENERAL.—For the purposes of this Act, a State shall have
primary enforcement responsibility for pesticide use violations
during any period for which the Administrator determines that
such State—
(1) has adopted adequate pesticide use laws and regulations,
except 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
(3) will keep such records and make such reports showing
compliance with paragraphs (1) and (2) of this subsection as the
Administrator may require by regulation.
(b) SPECIAL RULES.—Notwithstanding the provisions of subsection
(a) of this section, any State that enters into a cooperative agree-
ment with the Administrator under section 23 of this Act for the
enforcement of pesticide use restrictions shall have the primary en-
forcement responsibility for pesticide use violations. Any State that
has a plan approved by the Administrator in accordance with the
requirements of section 11 of this Act that the Administrator deter-
mines meets the criteria set out in subsection (a) of this section
shall have the primary enforcement responsibility for pesticide use
violations. The Administrator shall make such determinations with
respect to State plans under section 11 of this Act in effect on the
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Sec. 27
FIFRA
72
date of enactment of the Federal Pesticide Act of 1978 [September
30,1978] not later than six months after that date.
(c) ADMINISTRATOR.—The Administrator shall have primary en-
forcement responsibility for those States that do not have primary
enforcement responsibility under this Act. Not withstanding the
provisions of section 2(e)(l) 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 appli-
cators 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 ap-
plication.
SEC. 27. [136W-2] FAILURE BY THE STATE TO ASSURE ENFORCEMENT OF
STATE PESTICIDE USE REGULATIONS.
(a) REFERRAL.—Upon receipt of any complaint or other informa-
tion alleging or indicating 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
action, the Administrator may act upon the complaint or informa-
tion to the extent authorized under this Act.
(b) NOTICE.—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 responsibility, the Administrator
shall notify the State. Such notice shall specify those aspects of the
administration of the State program that are determined to be in-
adequate. The State shall have ninety days after receipt of the
notice to correct any deficiencies. If after that time the Administra-
tor determines that the State program remains inadequate, the Ad-
ministrator may rescind, in whole or in part, the State's primary
enforcement responsibility for pesticide use violations.
(c) CONSTRUCTION.—Neither section 26 of this Act nor this section
shall limit the authority of the Administrator to enforce this Act,
where the Administrator determines that emergency conditions
exist that require immediate action on the part of the Administra-
tor and the State authority is unwilling or unable adequately to re-
spond to the emergency.
SEC. 28. £136w-3] IDENTIFICATION OF PESTS; COOPERATION WITH DE-
PARTMENT OF AGRICULTURE'S PROGRAM.
The Administrator, in coordination with the Secretary of Agri-
culture, shall identify those pests that must be brought under con-
trol. The Administrator shall also coordinate and cooperate with
the Secretary of Agriculture's research and implementation pro-
grams 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 production and distri-
bution of agricultural products to domestic and foreign consumers.
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FIFRA
Sec. 31
SEC. 29. [136w-4] 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 ap-
plications for conditional registration under sections 3(c)(7)(B) and
3(c)(7)(C) of this Act that were filed during the immediately preced-
ing fiscal year, and, with respect to those applications approved,
the Administrator shall report the Administrator's findings in each
case, the conditions imposed and any modification of such condi-
tions in each case, and the quantities produced of such pesticides.
SEC. 30. £136x3 SEVERABILITY.
If any provision of this Act or the application thereof to any
person or circumstance is held invalid, the invalidity shall not
affect other provisions or applications 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. [136y] AUTHORIZATION FOR APPROPRIATIONS.
There is authorized to be appropriated to carry out this Act
(other than section 23(a))—
(1) $83,000,000 for fiscal year 1989, of which not more than
$13,735,500 shall be available for research under this Act;
(2) $95,000,000 for fiscal year 1990, of which not more than
$14,343,600 shall be available for research under this Act; and
(3) $95,000,000 for fiscal year 1991, of which not more than
$14,978,200 shall be available for research under this Act.
•d U.S. GOVERNMENT PRINTING OFFICE:1992-617-003/67066
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