Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)(1972)
TITLE 7--AGRICULTURE
CHAPTER 6--INSECTICIDES AND ENVIRONMENTAL PESTICIDE CONTROL
SUBCHAPTER I--INSECTICIDES
Sec. 121 to 134. Repealed
Secs. 121 to 134. Repealed. June 25, 1947, ch. 125, Sec. 16, 61
Stat. 172
Sections, act Apr. 26, 1910, ch. 191, 36 Stat. 335, formerly known
as ``The Insecticides Act, are covered by subchapter II of this
chapter.
Effective Date of Repeal; Savings Provision
Section 16 of act June 25, 1947, repealed this subchapter effective
one year after June 25, 1947, and further provided that this subchapter
should be deemed to remain in full force for the purpose of sustaining
any proper suit, action, or other proceeding with respect to any
violations, liabilities incurred, or appeals taken prior to such date of
repeal or to sales, shipments, or deliveries of insecticides and
fungicides exempted by the Secretary.
SUBCHAPTER II--ENVIRONMENTAL PESTICIDE CONTROL
Sec. 135 to 135k. Omitted.
Codification
Sections 135 to 135k, acts June 25, 1947, ch. 125, Secs. 2-13, 61
Stat. 163-172; Aug. 7, 1959, Pub. L. 86-139, Sec. 2, 73 Stat. 286; May
12, 1964, Pub. L. 88-305, Secs. 1-6, 78 Stat. 190-193; Oct. 15, 1970,
Pub. L. 91-452, title II, Sec. 204, 84 Stat. 928; Dec. 30, 1970, Pub. L.
91-601, Sec. 6(b), formerly Sec. 7(b), 84 Stat. 1673, renumbered, Aug.
13, 1981, Pub. L. 97-35, title XII, Sec. 1205(c), 95 Stat. 716, which
related to economic poison control, were superseded by the amendments
made to act June 25, 1947, by Pub. L. 92-516, Oct. 21, 1972, 86 Stat.
975. See section 4 of Pub. L. 92-516, set out as a note under section
136 of this title. The provisions of act June 25, 1947, as amended by
Pub. L. 92-516, are set out in section 136 et seq. of this title.
Section 135 provided definitions for the purposes of this
subchapter.
Section 135a related to prohibited acts.
Section 135b related to registration of economic poisons.
Section 135c related to access, inspection, and use in criminal
prosecutions of books and records.
Section 135d related to rules and regulations, examination of
economic poisons or devices, notification to violators, certification to
United States attorney, duty of attorney, and publication of judgments.
Section 135e related to exemptions from penalties.
Section 135f provided for penalties.
Section 135g related to seizure, disposal, and award of costs
against claimant.
Section 135h related to refusal of admission of imports.
Section 135i related to delegation of duties.
Section 135j related to authorization of appropriations and
expenditure of funds.
Section 135k related to cooperation between departments and
agencies.
Sec. 136. Definitions.
For purposes of this subchapter--
(a) Active ingredient
The term ``active ingredient means--
(1) in the case of a pesticide other than a plant regulator,
defoliant, desiccant, or nitrogen stabilizer, 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;
(4) in the case of a desiccant, an ingredient which will
artificially accelerate the drying of plant tissue; and
(5) in the case of a nitrogen stabilizer, an ingredient which
will prevent or hinder the process of nitrification,
denitrification, ammonia volatilization, or urease production
through action affecting soil bacteria.
(b) Administrator
The term ``Administrator means the Administrator of the
Environmental Protection Agency.
(c) Adulterated
The term ``adulterated applies to any pesticide if--
(1) its strength or purity falls below the professed standard of
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
(3) any valuable constituent of the pesticide has been wholly or
in part abstracted.
(d) Animal
The term ``animal means all vertebrate and invertebrate species,
including but not limited to man and other mammals, birds, fish, and
shellfish.
(e) Certified applicator, etc.
(1) Certified applicator
The term ``certified applicator means any individual who is
certified under section 136i of this title as authorized to use or
supervise the use of any pesticide which is classified for
restricted use. Any applicator who holds or applies registered
pesticides, or uses dilutions of registered pesticides consistent
with subsection (ee) of this section, 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 subchapter.
(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 the applicator or the applicators
employer or (if applied without compensation other than trading of
personal services between producers of agricultural commodities) on
the property of another person.
(3) Commercial applicator
The term ``commercial applicator means an applicator (whether
or not the applicator is a private applicator with respect to some
uses) who uses or supervises the use of any pesticide which is
classified for restricted use for any purpose or on any property
other than as provided by paragraph (2).
(4) Under the direct supervision of a certified applicator
Unless otherwise prescribed by its labeling, a pesticide shall
be considered to be applied under the direct supervision of a
certified applicator if it is applied by a competent person acting
under the instructions and control of a certified applicator who is
available if and when needed, even though such certified applicator
is not physically present at the time and place the pesticide is
applied.
(f) Defoliant
The term ``defoliant means any substance of mixture of substances
intended for causing the leaves or foliage to drop from a plant, with or
without causing abscission.
(g) Desiccant
The term ``desiccant means any substance or mixture of substances
intended for artificially accelerating the drying of plant tissue.
(h) Device
The term ``device means any instrument or contrivance (other than
a firearm) which is intended for trapping, destroying, repelling, or
mitigating any pest or any other form of plant or animal life (other
than man and other than bacteria, virus, or other microorganism on or in
living man or other living animals); but not including equipment used
for the application of pesticides when sold separately therefrom.
(i) District court
The term ``district court means a United States district court,
the District Court of Guam, the District Court of the Virgin Islands,
and the highest court of American Samoa.
(j) Environment
The term ``environment includes water, air, land, and all plants
and man and other animals living therein, and the interrelationships
which exist among these.
(k) 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, beverages, or pharmaceuticals.
(l) Imminent hazard
The term ``imminent hazard means a situation which exists when the
continued use of a pesticide during the time required for cancellation
proceeding would be likely to result in unreasonable adverse effects on
the environment or will involve unreasonable hazard to the survival of a
species declared endangered or threatened by the Secretary pursuant to
the Endangered Species Act of 1973 [16 U.S.C. 1531 et seq.].
(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, calculated as
elementary arsenic.
(o) Insect
The term ``insect means any of the numerous small invertebrate
animals generally having the body more or less obviously segmented, for
the most part belonging to the class insecta, comprising six-legged,
usually winged forms, as for example, beetles, bugs, bees, flies, and to
other allied classes of anthropods whose members are wingless and
usually have more than six legs, as for example, spiders, mites, ticks,
centipedes, and wood lice.
(p) Label and labeling
(1) Label
The term ``label means the written, printed, or graphic matter
on, or attached to, the pesticide or device or any of its containers
or wrappers.
(2) Labeling
The term ``labeling means all labels and all other written,
printed, or graphic matter--
(A) accompanying the pesticide or device at any time; or
(B) to which reference is made on the label or in literature
accompanying the pesticide or device, except to current official
publications of the Environmental Protection Agency, the United
States Departments of Agriculture and Interior, the Department
of Health and Human Services, State experiment stations, State
agricultural colleges, and other similar Federal or State
institutions or agencies authorized by law to conduct research
in the field of pesticides.
(q) Misbranded
(1) A pesticide is misbranded if--
(A) its labeling bears any statement, design, or graphic
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 established by
the Administrator pursuant to section 136w(c)(3) of this title;
(C) it is an imitation of, or is offered for sale under the
name of, another pesticide;
(D) its label does not bear the registration number assigned
under section 136e of this title to each establishment in which
it was produced;
(E) any word, statement, or other information required by or
under authority of this subchapter to appear on the label or
labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements,
designs, or graphic matter in the labeling) and in such terms as
to render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use;
(F) the labeling accompanying it does not contain directions
for use which are necessary for effecting the purpose for which
the product is intended and if complied with, together with any
requirements imposed under section 136a(d) of this title, are
adequate to protect health and the environment;
(G) the label does not contain a warning or caution
statement which may be necessary and if complied with, together
with any requirements imposed under section 136a(d) of this
title, is adequate to protect health and the environment; or
(H) in the case of a pesticide not registered in accordance
with section 136a of this title and intended for export, the
label does not contain, in words prominently placed thereon with
such conspicuousness (as compared with other words, statements,
designs, or graphic matter in the labeling) as to render it
likely to be noted by the ordinary individual under customary
conditions of purchase and use, the following: ``Not Registered
for Use in the United States of America.
(2) A pesticide is misbranded if--
(A) the label does not bear an ingredient statement on that
part of the immediate container (and on the outside container or
wrapper of the retail package, if there be one, through which
the ingredient statement on the immediate container cannot be
clearly read) which is presented or displayed under customary
conditions or purchase, except that a pesticide is not
misbranded under this subparagraph if--
(i) The size or form of the immediate container, or the
outside container or wrapper of the retail package, makes it
impracticable to place the ingredient statement on the part
which is presented or displayed under customary conditions
of purchase; and
(ii) the ingredient statement appears prominently on
another part of the immediate container, or outside
container or wrapper, permitted by the Administrator;
(B) the labeling does not contain a statement of the use
classification under which the product is registered;
(C) there is not affixed to its container, and to the
outside container or wrapper of the retail package, if there be
one, through which the required information on the immediate
container cannot be clearly read, a label bearing--
(i) the name and address of the producer, registrant, or
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 variations; and
(iv) when required by regulation of the Administrator to
effectuate the purposes of this subchapter, the registration
number assigned to the pesticide under this subchapter, 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 subchapter--
(i) the skull and crossbones;
(ii) the word ``poison prominently in red on a
background of distinctly contrasting color; and
(iii) a statement of a practical treatment (first aid or
otherwise) in case of poisoning by the pesticide.
(r) Nematode
The term ``nematode means invertebrate animals of the phylum
nemathelminthes and class nematoda, that is, unsegmented round worms
with elongated, fusiform, or saclike bodies covered with cuticle, and
inhabiting soil, water, plants, or plant parts; may also be called nemas
or eelworms.
(s) Person
The term ``person means any individual, partnership, association,
corporation, or any organized group of persons whether incorporated or
not.
(t) Pest
The term ``pest means (1) any insect, rodent, nematode, fungus,
weed, or (2) any other form of terrestrial or aquatic plant or animal
life or virus, bacteria, or other micro-organism (except viruses,
bacteria, or other micro-organisms on or in living man or other living
animals) which the Administrator declares to be a pest under section
136w(c)(1) of this title.
(u) Pesticide
The term ``pesticide means (1) any substance or mixture of
substances intended for preventing, destroying, repelling, or mitigating
any pest, (2) any substance or mixture of substances intended for use as
a plant regulator, defoliant, or desiccant, and (3) any nitrogen
stabilizer, except that the term ``pesticide shall not include any
article that is a ``new animal drug within the meaning of section
321(w) \1\ of title 21, that has been determined by the Secretary of
Health and Human Services not to be a new animal drug by a regulation
establishing conditions of use for the article, or that is an animal
feed within the meaning of section 321(x) \1\ of title 21 bearing or
containing a new animal drug. The term ``pesticide does not include
liquid chemical sterilant products (including any sterilant or
subordinate disinfectant claims on such products) for use on a critical
or semi-critical device, as defined in section 321 of title 21. For
purposes of the preceding sentence, the term ``critical device
includes any device which is introduced directly into the human body,
either into or in contact with the bloodstream or normally sterile areas
of the body and the term ``semi-critical device includes any device
which contacts intact mucous membranes but which does not ordinarily
penetrate the blood barrier or otherwise enter normally sterile areas of
the body.
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\1\ See References in Text note below.
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(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 improvement, maintenance, survival, health, and
propagation of plants, and as are not for pest destruction and are
nontoxic, nonpoisonous in the undiluted packaged concentration.
(w) Producer and produce
The term ``producer means the person who manufactures, prepares,
compounds, propagates, or processes any pesticide or device or active
ingredient used in producing a pesticide. The term ``produce means to
manufacture, prepare, compound, propagate, or process any pesticide or
device or active ingredient used in producing a pesticide. The dilution
by individuals of formulated pesticides for their own use and 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 subchapter.
(x) Protect health and the environment
The terms ``protect health and the environment and ``protection of
health and the environment mean protection against any unreasonable
adverse effects on the environment.
(y) Registrant
The term ``registrant means a person who has registered any
pesticide pursuant to the provisions of this subchapter.
(z) Registration
The term ``registration includes reregistration.
(aa) State
The term ``State means a State, the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Trust
Territory of the Pacific Islands, and American Samoa.
(bb) Unreasonable adverse effects on the environment
The term ``unreasonable adverse effects on the environment means
(1) 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, or (2) a human dietary risk from residues that result
from a use of a pesticide in or on any food inconsistent with the
standard under section 346a of title 21. The Administrator shall
consider the risks and benefits of public health pesticides separate
from the risks and benefits of other pesticides. In weighing any
regulatory action concerning a public health pesticide under this
subchapter, the Administrator shall weigh any risks of the pesticide
against the health risks such as the diseases transmitted by the vector
to be controlled by the 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 producing a pesticide is produced,
or held, for distribution or sale.
(ee) To use any registered pesticide in a manner inconsistent with its
labeling
The term ``to use any registered pesticide in a manner inconsistent
with its labeling means to use any registered pesticide in a manner
not permitted by the labeling, except that the term shall not include
(1) applying a pesticide at any 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 pesticide against any target pest not
specified on the labeling if the application is to the crop, animal, or
site specified on the labeling, unless the Administrator has required
that the labeling specifically state that the pesticide may be used only
for the pests specified on the labeling after the Administrator has
determined that the use of the pesticide against other pests would cause
an unreasonable adverse effect on the environment, (3) employing any
method of application not prohibited by the labeling unless the labeling
specifically states that the product may be applied only by the methods
specified on the labeling, (4) mixing a pesticide or pesticides with a
fertilizer when such mixture is not prohibited by the labeling, (5) any
use of a pesticide in conformance with section 136c, 136p, or 136v of
this title, or (6) any use of a pesticide in a manner that the
Administrator determines to be consistent with the purposes of this
subchapter. After March 31, 1979, the term shall not include the use of
a pesticide for agricultural or forestry purposes at a dilution less
than label dosage unless before or after that date the Administrator
issues a regulation or advisory opinion consistent with the study
provided for in section 27(b) of the Federal Pesticide Act of 1978,
which regulation or advisory opinion specifically requires the use of
definite amounts of dilution.
(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 136a(c)(5) of this title 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
136a(c)(5) of this title 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 determine 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 deliver. The term does not include the
holding or application of registered pesticides or use dilutions thereof
by any applicator who provides a service of controlling pests without
delivering any unapplied pesticide to any person so served.
(hh) Nitrogen stabilizer
The term ``nitrogen stabilizer means any substance or mixture of
substances intended for preventing or hindering the process of
nitrification, denitrification, ammonia volatilization, or urease
production through action upon soil bacteria. Such term shall not
include--
(1) dicyandiamide;
(2) ammonium thiosulfate; or
(3) any substance or mixture of substances.-- \2\
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\2\ So in original. Period probably should not appear.
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(A) that was not registered pursuant to section 136a of this
title prior to January 1, 1992; and
(B) that was in commercial agronomic use prior to January 1,
1992, with respect to which after January 1, 1992, the
distributor or seller of the substance or mixture has made no
specific claim of prevention or hindering of the process of
nitrification, denitrification, ammonia volatilization \3\
urease production regardless of the actual use or purpose for,
or future use or purpose for, the substance or mixture.
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\3\ So in original. Probably should be followed by ``, or.
Statements made in materials required to be submitted to any State
legislative or regulatory authority, or required by such authority to be
included in the labeling or other literature accompanying any such
substance or mixture shall not be deemed a specific claim within the
meaning of this subsection.
(jj) \4\ Maintenance applicator
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\4\ So in original. No subsec. (ii) was enacted.
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The term ``maintenance applicator means any individual who, in the
principal course of such individuals employment, uses, or supervises
the use of, a pesticide not classified for restricted use (other than a
ready to use consumer products pesticide); for the purpose of providing
structural pest control or lawn pest control including janitors, general
maintenance personnel, sanitation personnel, and grounds maintenance
personnel. The term ``maintenance applicator does not include private
applicators as defined in subsection (e)(2) of this section; individuals
who use antimicrobial pesticides, sanitizers or disinfectants;
individuals employed by Federal, State, and local governments or any
political subdivisions thereof, or individuals who use pesticides not
classified for restricted use in or around their homes, boats, sod
farms, nurseries, greenhouses, or other noncommercial property.
(kk) Service technician
The term ``service technician means any individual who uses or
supervises the use of pesticides (other than a ready to use consumer
products pesticide) for the purpose of providing structural pest control
or lawn pest control on the property of another for a fee. The term
``service technician does not include individuals who use
antimicrobial pesticides, sanitizers or disinfectants; or who otherwise
apply ready to use consumer products pesticides.
(ll) Minor use
The term ``minor use means the use of a pesticide on an animal, on
a commercial agricultural crop or site, or for the protection of public
health where--
(1) the total United States acreage for the crop is less than
300,000 acres, as determined by the Secretary of Agriculture; or
(2) the Administrator, in consultation with the Secretary of
Agriculture, determines that, based on information provided by an
applicant for registration or a registrant, the use does not provide
sufficient economic incentive to support the initial registration or
continuing registration of a pesticide for such use and--
(A) there are insufficient efficacious alternative
registered pesticides available for the use;
(B) the alternatives to the pesticide use pose greater risks
to the environment or human health;
(C) the minor use pesticide plays or will play a significant
part in managing pest resistance; or
(D) the minor use pesticide plays or will play a significant
part in an integrated pest management program.
The status as a minor use under this subsection shall continue as long
as the Administrator has not determined that, based on existing data,
such use may cause an unreasonable adverse effect on the environment and
the use otherwise qualifies for such status.
(mm) Antimicrobial pesticide
(1) In general
The term ``antimicrobial pesticide means a pesticide that--
(A) is intended to--
(i) disinfect, sanitize, reduce, or mitigate growth or
development of microbiological organisms; or
(ii) protect inanimate objects, industrial processes or
systems, surfaces, water, or other chemical substances from
contamination, fouling, or deterioration caused by bacteria,
viruses, fungi, protozoa, algae, or slime; and
(B) in the intended use is exempt from, or otherwise not
subject to, a tolerance under section 346a of title 21 or a food
additive regulation under section 348 of title 21.
(2) Excluded products
The term ``antimicrobial pesticide does not include--
(A) a wood preservative or antifouling paint product for
which a claim of pesticidal activity other than or in addition
to an activity described in paragraph (1) is made;
(B) an agricultural fungicide product; or
(C) an aquatic herbicide product.
(3) Included products
The term ``antimicrobial pesticide does include any other
chemical sterilant product (other than liquid chemical sterilant
products exempt under subsection (u) of this section), any other
disinfectant product, any other industrial microbiocide product, and
any other preservative product that is not excluded by paragraph
(2).
(nn) Public health pesticide
The term ``public health pesticide means any minor use pesticide
product registered for use and used predominantly in public health
programs for vector control or for other recognized health protection
uses, including the prevention or mitigation of viruses, bacteria, or
other microorganisms (other than viruses, bacteria, or other
microorganisms on or in living man or other living animal) that pose a
threat to public health.
(oo) Vector
The term ``vector means any organism capable of transmitting the
causative agent of human disease or capable of producing human
discomfort or injury, including mosquitoes, flies, fleas, cockroaches,
or other insects and ticks, mites, or rats.
(June 25, 1947, ch. 125, Sec. 2, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 975; amended Pub. L. 93-205, Sec. 13(f), Dec. 28,
1973, 87 Stat. 903; Pub. L. 94-140, Sec. 9, Nov. 28, 1975, 89 Stat. 754;
Pub. L. 95-396, Sec. 1, Sept. 30, 1978, 92 Stat. 819; Pub. L. 100-532,
title I, Sec. 101, title VI, Sec. 601(a), title VIII, Sec. 801(a), Oct.
25, 1988, 102 Stat. 2655, 2677, 2679; Pub. L. 102-237, title X,
Sec. 1006(a)(1), (2), (b)(3)(A), (B), Dec. 13, 1991, 105 Stat. 1894,
1895; Pub. L. 104-170, title I, Secs. 105(a), 120, title II,
Secs. 210(a), 221, 230, title III, Sec. 304, Aug. 3, 1996, 110 Stat.
1490, 1492, 1493, 1502, 1508, 1512.)
References in Text
The Endangered Species Act of 1973, referred to in subsec. (l), is
Pub. L. 93-205, Dec. 28, 1973, 87 Stat. 884, as amended, which is
classified generally to chapter 35 (Sec. 1531 et seq.) of Title 16,
Conservation. For complete classification of this Act to the Code, see
Short Title note set out under section 1531 of Title 16 and Tables.
Section 321 of title 21, referred to in subsec. (u), was
subsequently amended, and subsecs. (w) and (x) of section 321 no longer
define the terms ``new animal drug and ``animal feed, respectively.
However, such terms are defined elsewhere in that section.
Section 27(b) of Federal Pesticide Act of 1978, referred to in
subsec. (ee), is section 27(b) of Pub. L. 95-396, Sept. 30, 1978, 92
Stat. 841, which was formerly set out as a note under section 136w-4 of
this title.
Prior Provisions
A prior section 2 of act June 25, 1947, was classified to section
135 of this title prior to amendment of act June 25, 1947, by Pub. L.
92-516.
Amendments
1996--Subsec. (a)(1). Pub. L. 104-170, Sec. 105(a)(1)(A),
substituted ``defoliant, desiccant, or nitrogen stabilizer for
``defoliant, or desiccant.
Subsec. (a)(5). Pub. L. 104-170, Sec. 105(a)(1)(B)-(D), added par.
(5).
Subsec. (u). Pub. L. 104-170, Secs. 105(a)(2), 221(1), struck out
``and before ``(2), inserted ``and (3) any nitrogen stabilizer,
after ``desiccant,, and inserted at end ``The term `pesticide does
not include liquid chemical sterilant products (including any sterilant
or subordinate disinfectant claims on such products) for use on a
critical or semi-critical device, as defined in section 321 of title 21.
For purposes of the preceding sentence, the term `critical device
includes any device which is introduced directly into the human body,
either into or in contact with the bloodstream or normally sterile areas
of the body and the term `semi-critical device includes any device
which contacts intact mucous membranes but which does not ordinarily
penetrate the blood barrier or otherwise enter normally sterile areas of
the body.
Subsec. (bb). Pub. L. 104-170, Sec. 304, which directed amendment of
section 2(bb) by inserting ``(1) after ``means and adding cl. (2),
without specifying the Act being amended, was executed to this
subsection, which is section 2(bb) of the Federal Insecticide,
Fungicide, and Rodenticide Act, to reflect the probable intent of
Congress.
Pub. L. 104-170, Sec. 230(a), inserted at end ``The Administrator
shall consider the risks and benefits of public health pesticides
separate from the risks and benefits of other pesticides. In weighing
any regulatory action concerning a public health pesticide under this
subchapter, the Administrator shall weigh any risks of the pesticide
against the health risks such as the diseases transmitted by the vector
to be controlled by the pesticide.
Subsec. (hh). Pub. L. 104-170, Sec. 105(a)(3), added subsec. (hh).
Subsecs. (jj), (kk). Pub. L. 104-170, Sec. 120, added subsecs. (jj)
and (kk).
Subsec. (ll). Pub. L. 104-170, Sec. 210(a), added subsec. (ll).
Subsec. (mm). Pub. L. 104-170, Sec. 221(2), added subsec. (mm).
Subsecs. (nn), (oo). Pub. L. 104-170, Sec. 230(b), added subsecs.
(nn) and (oo).
1991--Subsec. (e)(1). Pub. L. 102-237, Sec. 1006(a)(1), substituted
``section 136i for ``section 136b and ``uses dilutions for ``use
dilutions and made technical amendment to reference to subsection (ee)
of this section involving corresponding provision of original act.
Subsec. (e)(2). Pub. L. 102-237, Sec. 1006(b)(3)(A), substituted
``the applicator or the applicators for ``him or his.
Subsec. (e)(3). Pub. L. 102-237, Sec. 1006(b)(3)(B), substituted
``the applicator for ``he.
Subsec. (q)(2)(A)(i). Pub. L. 102-237, Sec. 1006(a)(2), substituted
``size or form for ``size of form.
1988--Subsec. (c). Pub. L. 100-532, Sec. 801(a)(1), substituted
``if-- for ``if:.
Subsec. (p)(2)(B). Pub. L. 100-532, Sec. 801(a)(2), substituted
``Health and Human Services for ``Health, Education, and Welfare.
Subsec. (q)(2)(A). Pub. L. 100-532, Sec. 801(a)(3), substituted
``if-- for ``if:.
Subsec. (q)(2)(C)(iii). Pub. L. 100-532, Sec. 801(a)(4), substituted
``, except that for ``: Provided, That.
Subsec. (u). Pub. L. 100-532, Sec. 801(a)(5), substituted ``, except
that for ``: Provided, That, struck out ``(1)(a) after ``include
any article and ``or (b) after ``section 321(w) of title 21,, and
substituted ``Health and Human Services for ``Health, Education, and
Welfare, ``or that is for ``or (2) that is, and ``a new animal
drug for ``an article covered by clause (1) of this proviso.
Subsec. (ee). Pub. L. 100-532, Secs. 601(a)(1), 801(a)(6),
substituted ``, except that for ``: Provided, That, inserted
``unless the labeling specifically prohibits deviation from the
specified dosage, concentration, or frequency and ``unless the
labeling specifically states that the product may be applied only by the
methods specified on the labeling, substituted ``labeling, (4)
mixing for ``labeling, or (4) mixing, ``, (5) for ``: Provided
further, That the term also shall not include, ``or (6) any use for
``or any use, and ``. After for ``: And provided further, That
after.
Subsec. (ff). Pub. L. 100-532, Sec. 101, added subsec. (ff).
Subsec. (gg). Pub. L. 100-532, Sec. 601(a)(2), added subsec. (gg).
1978--Subsec. (e)(1). Pub. L. 95-396, Sec. 1(1), inserted provision
deeming an applicator not a seller or distributor of pesticides when
providing a service of controlling pests.
Subsec. (e)(3). Pub. L. 95-396, Sec. 1(2), substituted ``an
applicator for ``a certified applicator.
Subsec. (q)(1)(H). Pub. L. 95-396, Sec. 1(3), added subpar. (H).
Subsec. (w). Pub. L. 95-396, Sec. 1(4), (5), amended definition of
``producer and ``produce to include reference to active ingredient
used in producing a pesticide and inserted provision that an individual
did not become a producer when there was dilution of a pesticide for
personal use according to directions on registered labels.
Subsec. (dd). Pub. L. 95-396, Sec. 1(6), inserted ``or active
ingredient used in producing a pesticide.
Subsec. (ee). Pub. L. 95-396, Sec. 1(7), added subsec. (ee).
1975--Subsec. (u). Pub. L. 94-140 inserted proviso which excluded
from term ``pesticide any article designated as ``new animal drug
and any article denominated as animal feed.
1973--Subsec. (l). Pub. L. 93-205 substituted ``or threatened by the
Secretary pursuant to the Endangered Species Act of 1973 for ``by the
Secretary of the Interior under Public Law 91-135.
Effective Date of 1988 Amendment
Section 901 of Pub. L. 100-532 provided that: ``Except as otherwise
provided in this Act, the amendments made by this Act [see Short Title
of 1988 Amendment note below] shall take effect on the expiration of 60
days after the date of enactment of this Act [Oct. 25, 1988].
Effective Date of 1973 Amendment
Amendment by Pub. L. 93-205 effective Dec. 28, 1973, see section 16
of Pub. L. 93-205, set out as an Effective Date note under section 1531
of Title 16, Conservation.
Effective Date
Section 4 of Pub. L. 92-516, as amended by Pub. L. 94-140, Sec. 4,
Nov. 28, 1975, 89 Stat. 752; Pub. L. 95-396, Sec. 28, Sept. 30, 1978, 92
Stat. 842, provided that:
``(a) Except as otherwise provided in the Federal Insecticide,
Fungicide, and Rodenticide Act [this subchapter], as amended by this Act
and as otherwise provided by this section, the amendments made by this
Act [see Short Title note set out below] shall take effect at the close
of the date of the enactment of this Act [Oct. 21, 1972], provided if
regulations are necessary for the implementation of any provision that
becomes effective on the date of enactment, such regulations shall be
promulgated and shall become effective within 90 days from the date of
enactment of this Act.
``(b) The provisions of the Federal Insecticide, Fungicide, and
Rodenticide Act [this subchapter] and the regulations thereunder as such
existed prior to the enactment of this Act shall remain in effect until
superseded by the amendments made by this Act and regulations
thereunder.
``(c)(1) Two years after the enactment of this Act the Administrator
shall have promulgated regulations providing for the registration and
classification of pesticides under the provisions of this Act and
thereafter shall register all new applications under such provisions.
``(2) Any requirements that a pesticide be registered for use only
by a certified applicator shall not be effective until five years from
the date of enactment of this Act.
``(3) A period of five years from date of enactment shall be
provided for certification of applicators.
``(A) One year after the enactment of this Act the Administrator
shall have prescribed the standards for the certification of
applicators.
``(B) Each State desiring to certify applicators shall submit a
State plan to the Administrator for the purpose provided by section
4(b).
``(C) As promptly as possible but in no event more than one year
after submission of a State plan, the Administrator shall approve
the State plan or disapprove it and indicate the reasons for
disapproval. Consideration of plans resubmitted by States shall be
expedited.
``(4) One year after the enactment of this Act the Administrator
shall have promulgated and shall make effective regulations relating to
the registration of establishments, permits for experimental use, and
the keeping of books and records under the provisions of this Act.
``(d) No person shall be subject to any criminal or civil penalty
imposed by the Federal Insecticide, Fungicide, and Rodenticide Act, as
amended by this Act, for any act (or failure to act) occurring before
the expiration of 60 days after the Administrator has published
effective regulations in the Federal Register and taken such other
action as may be necessary to permit compliance with the provisions
under which the penalty is to be imposed.
``(e) For purposes of determining any criminal or civil penalty or
liability to any third person in respect of any act or omission
occurring before the expiration of the periods referred to in this
section, the Federal Insecticide, Fungicide, and Rodenticide Act shall
be treated as continuing in effect as if this Act had not been
enacted.
Short Title of 1996 Amendment
Section 1 of Pub. L. 104-170 provided that: ``This Act [enacting
sections 136i-2, 136r-1, and 136w-5 to 136w-7 of this title, amending
this section, sections 136a, 136a-1, 136d, 136q, 136s, 136w, 136w-3,
136x, and 136y of this title, and sections 321, 331, 333, 342, and 346a
of Title 21, Food and Drugs, and enacting provisions set out as notes
under section 136i-2 of this title and sections 301 and 346a of Title
21] may be cited as the `Food Quality Protection Act of 1996.
[Another Food Quality Protection Act of 1996 was enacted by Pub. L.
104-170, title IV, 110 Stat. 1513, see section 401(a) of Pub. L. 104-
170, set out as a note under section 301 of Title 21, Food and Drugs.]
Short Title of 1988 Amendment
Section 1(a) of Pub. L. 100-532 provided that: ``This Act [enacting
section 136a-1 of this title, amending this section and sections 136a to
136d, 136f to 136q, 136s, 136v to 136w-2, and 136y of this title, and
enacting provisions set out as notes under this section and sections
136m and 136y of this title] may be cited as the `Federal Insecticide,
Fungicide, and Rodenticide Act Amendments of 1988.
Short Title of 1978 Amendment
Section 29 of Pub. L. 95-396 provided that: ``This Act [enacting
sections 136w-1 to 136w-4 of this title, amending this section and
sections 136a to 136f, 136h, 136j, 136l, 136o, 136q, 136r, 136u to 136w,
136x, and 136y of this title, enacting provisions set out as notes under
sections 136a, 136o, and 136w-4 of this title, and amending provisions
set out as a note under this section] may be cited as the `Federal
Pesticide Act of 1978.
Short Title
Section 1 of Pub. L. 92-516 provided: ``That this Act [amending this
subchapter generally, enacting notes set out under this section, and
amending sections 1261 and 1471 of Title 15, Commerce and Trade, and
sections 321 and 346a of Title 21, Foods and Drugs] may be cited as the
`Federal Environmental Pesticide Control Act of 1972.
Section 1(a) of act June 25, 1947, as added by Pub. L. 92-516,
Sec. 2, provided that: ``This Act [enacting this subchapter] may be
cited as the `Federal Insecticide, Fungicide, and Rodenticide Act.
Termination of Trust Territory of the Pacific Islands
For termination of Trust Territory of the Pacific Islands, see note
set out preceding section 1681 of Title 48, Territories and Insular
Possessions.
Federal Compliance With Pollution Control Standards
For provisions relating to the responsibility of the head of each
Executive agency for compliance with applicable pollution control
standards, see Ex. Ord. No. 12088, Oct. 13, 1978, 43 F.R. 47707, set out
as a note under section 4321 of Title 42, The Public Health and Welfare.
Section Referred to in Other Sections
This section is referred to in sections 136a, 136o, 136w, 136w-1,
138 of this title.
Sec. 136a. Registration of pesticides.
(a) Requirement of registration
Except as provided by this subchapter, no person in any State may
distribute or sell to any person any pesticide that is not registered
under this subchapter. To the extent necessary to prevent unreasonable
adverse effects on the environment, the Administrator may by regulation
limit the distribution, sale, or use in any State of any pesticide that
is not registered under this subchapter and that is not the subject of
an experimental use permit under section 136c of this title or an
emergency exemption under section 136p of this title.
(b) Exemptions
A pesticide which is not registered with the Administrator may be
transferred if--
(1) the transfer is from one registered establishment to another
registered establishment operated by the same producer solely for
packaging at the second establishment or for use as a constituent
part of another pesticide produced at the second establishment; or
(2) the transfer is pursuant to and in accordance with the
requirements 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 directions
for its use;
(D) the complete formula of the pesticide;
(E) a request that the pesticide be classified for general
use or for restricted use, or for both; and
(F) 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 submitted to the
Administrator and that the Administrator may consider in
accordance with the following provisions:
(i) With respect to pesticides containing active
ingredients that are initially registered under this
subchapter after September 30, 1978, data submitted to
support the application for the original registration of the
pesticide, 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 permission of the
original data submitter, be considered by the Administrator
to support an application by another 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) The period of exclusive data use provided under
clause (i) shall be extended 1 additional year for each 3
minor uses registered after August 3, 1996, and within 7
years of the commencement of the exclusive use period, up to
a total of 3 additional years for all minor uses registered
by the Administrator if the Administrator, in consultation
with the Secretary of Agriculture, determines that, based on
information provided by an applicant for registration or a
registrant, that--
(I) there are insufficient efficacious alternative
registered pesticides available for the use;
(II) the alternatives to the minor use pesticide
pose greater risks to the environment or human health;
(III) the minor use pesticide plays or will play a
significant part in managing pest resistance; or
(IV) the minor use pesticide plays or will play a
significant part in an integrated pest management
program.
The registration of a pesticide for a minor use on a crop
grouping established by the Administrator shall be
considered for purposes of this clause 1 minor use for each
representative crop for which data are provided in the crop
grouping. Any additional exclusive use period under this
clause shall be modified as appropriate or terminated if the
registrant voluntarily cancels the product or deletes from
the registration the minor uses which formed the basis for
the extension of the additional exclusive use period or if
the Administrator determines that the registrant is not
actually marketing the product for such minor uses.
(iii) 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 amendment adding a
new use to an existing registration, to support or maintain
in effect an existing registration, 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 referred to as the ``applicant)
within the fifteen-year period following the date the data
were originally submitted only if the applicant has made an
offer to compensate the original data submitter and
submitted such offer to the Administrator accompanied by
evidence of delivery to the original data submitter of the
offer. The terms and amount of compensation may be fixed by
agreement between the original data submitter and the
applicant, or, failing such agreement, binding arbitration
under this subparagraph. If, at the end of ninety 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
Federal 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,
misrepresentation, or other misconduct. The parties to the
arbitration shall share equally in the payment of the fee
and expenses of the arbitrator. If the Administrator
determines that an original data submitter has failed to
participate in a procedure for reaching an agreement or in
an arbitration proceeding as required by this subparagraph,
or failed to comply with the terms of an agreement or
arbitration decision concerning compensation under this
subparagraph, the original data submitter shall forfeit the
right to compensation for the use of the data in support of
the application. Notwithstanding any other provision of this
subchapter, if the Administrator determines that an
applicant has failed to participate in a procedure for
reaching an agreement or in an arbitration proceeding as
required by this subparagraph, or failed to comply with the
terms of an agreement or arbitration decision concerning
compensation under this subparagraph, the Administrator
shall deny the application or cancel the registration of the
pesticide in support of which the data were used without
further hearing. Before the Administrator takes action under
either of the preceding two sentences, the Administrator
shall furnish to the affected person, by certified mail,
notice of intent to take action and allow fifteen days from
the date of delivery of the notice for the affected person
to respond. If a registration is denied or canceled under
this subparagraph, the Administrator may make such order as
the Administrator deems appropriate concerning the continued
sale and use of existing stocks of such pesticide.
Registration action by the Administrator shall not be
delayed pending the fixing of compensation.
(iv) 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), (ii), and (iii), the
Administrator may consider such item of data in support of
an application by any other applicant without the permission
of the original data submitter and without an offer having
been received to compensate the original data submitter for
the use of such item of data.
(v) The period of exclusive use provided under clause
(ii) shall not take effect until 1 year after August 3,
1996, except where an applicant or registrant is applying
for the registration of a pesticide containing an active
ingredient not previously registered.
(vi) With respect to data submitted after August 3,
1996, by an applicant or registrant to support an amendment
adding a new use to an existing registration that does not
retain any period of exclusive use, if such data relates
solely to a minor use of a pesticide, such data shall not,
without the written permission of the original data
submitter, be considered by the Administrator to support an
application for a minor use by another person during the
period of 10 years following the date of submission of such
data. The applicant or registrant at the time the new minor
use is requested shall notify the Administrator that to the
best of their knowledge the exclusive use period for the
pesticide has expired and that the data pertaining solely to
the minor use of a pesticide is eligible for the provisions
of this paragraph. If the minor use registration which is
supported by data submitted pursuant to this subsection is
voluntarily canceled or if such data are subsequently used
to support a nonminor use, the data shall no longer be
subject to the exclusive use provisions of this clause but
shall instead be considered by the Administrator in
accordance with the provisions of clause (i), as
appropriate.
(G) If the applicant is requesting that the registration or
amendment to the registration of a pesticide be expedited, an
explanation of the basis for the request must be submitted, in
accordance with paragraph (10) of this subsection.
(2) Data in support of registration
(A) In general
The Administrator shall publish guidelines specifying the
kinds of information which will be required to support the
registration of a pesticide and shall revise such guidelines
from time to time. If thereafter the Administrator requires any
additional kind of information under subparagraph (B) of this
paragraph, the Administrator shall permit sufficient time for
applicants to obtain such additional information. The
Administrator, in establishing standards for data requirements
for the registration of pesticides with respect to minor uses,
shall make such standards commensurate with the anticipated
extent of use, pattern of use, the public health and
agricultural need for such minor use, and the level and degree
of potential beneficial or adverse effects on man and the
environment. The Administrator shall not require a person to
submit, in relation to a registration or reregistration of a
pesticide for minor agricultural use under this subchapter, any
field residue data from a geographic area where the pesticide
will not be registered for such use. In the development of these
standards, the Administrator shall consider the economic factors
of potential national volume of use, extent of distribution, and
the impact of the cost of meeting the requirements on the
incentives for any potential registrant to undertake the
development of the required data. Except as provided by section
136h of this title, within 30 days after the Administrator
registers a pesticide under this subchapter the Administrator
shall make available to the public the data called for in the
registration statement together with such other scientific
information as the Administrator deems relevant to the
Administrators decision.
(B) Additional data
(i) If the Administrator determines that additional data are
required to maintain in effect an existing registration of a
pesticide, the Administrator shall notify all existing
registrants of the pesticide to which the determination relates
and provide a list of such registrants to any interested person.
(ii) Each registrant of such pesticide shall provide
evidence within ninety days after receipt of notification that
it is taking 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
Administrator of their agreement to develop jointly, or share in
the cost of developing, data, the registrants have not further
agreed on the terms of the data development arrangement or on a
procedure for reaching such agreement, any of such registrants
may initiate binding arbitration proceedings by requesting the
Federal Mediation and Conciliation Service to appoint an
arbitrator from the roster of arbitrators maintained by such
Service. The 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, misrepresentation, or other misconduct.
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 procedures
prescribed by clause (iv) if a registrant fails to comply with
this clause.
(iv) Notwithstanding any other provision of this subchapter,
if the Administrator determines that a registrant, within the
time required by the Administrator, has failed to take
appropriate steps to secure the data required under this
subparagraph, to participate in a procedure for reaching
agreement concerning a joint data development arrangement under
this subparagraph or in an arbitration proceeding as required by
this subparagraph, or to comply with the terms of an agreement
or arbitration decision concerning a joint data development
arrangement under this subparagraph, the Administrator may issue
a notice of intent to suspend such registrants registration of
the pesticide for which additional data is required. The
Administrator may include in the notice of intent to suspend
such provisions as the Administrator deems appropriate
concerning the continued sale and use of existing stocks of such
pesticide. Any suspension proposed under this subparagraph shall
become final and effective at the end of thirty days from
receipt by the registrant of the notice of intent to suspend,
unless during that time a request for hearing is made by a
person adversely affected by the notice or the registrant has
satisfied the Administrator that the registrant has complied
fully with the requirements that served as a basis for the
notice of intent to suspend. If a hearing is requested, a
hearing shall be conducted under section 136d(d) of this title.
The only matters for resolution at that hearing shall be whether
the registrant has failed to take the action that served as the
basis for the notice of intent to suspend the registration of
the pesticide for which additional data is required, and whether
the Administrators determination with respect to the
disposition of existing stocks is consistent with this
subchapter. If a hearing is held, a decision after completion of
such hearing shall be final. Notwithstanding any other provision
of this subchapter, a hearing shall be held and a determination
made within seventy-five days after receipt of a request for
such hearing. Any registration suspended under this subparagraph
shall be reinstated by the Administrator if the Administrator
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 submission to handle
any subsequent data compensation matters for the joint
submitters of such data.
(vi) Upon the request of a registrant the Administrator
shall, in the case of a minor use, extend the deadline for the
production of residue chemistry data under this subparagraph for
data required solely to support that minor use until the final
deadline for submission of data under section 136a-1 of this
title for the other uses of the pesticide established as of
August 3, 1996, if--
(I) the data to support other uses of the pesticide on a
food are being provided;
(II) the registrant, in submitting a request for such an
extension, provides a schedule, including interim dates to
measure progress, to assure that the data production will be
completed before the expiration of the extension period;
(III) the Administrator has determined that such
extension will not significantly delay the Administrators
schedule for issuing a reregistration eligibility
determination required under section 136a-1 of this title;
and
(IV) the Administrator has determined that based on
existing data, such extension would not significantly
increase the risk of any unreasonable adverse effect on the
environment. If the Administrator grants an extension under
this clause, the Administrator shall monitor the development
of the data and shall ensure that the registrant is meeting
the schedule for the production of the data. If the
Administrator determines that the registrant is not meeting
or has not met the schedule for the production of such data,
the Administrator may proceed in accordance with clause (iv)
regarding the continued registration of the affected
products with the minor use and shall inform the public of
such action. Notwithstanding the provisions of this clause,
the Administrator may take action to modify or revoke the
extension under this clause if the Administrator determines
that the extension for the minor use may cause an
unreasonable adverse effect on the environment. In such
circumstance, the Administrator shall provide, in writing to
the registrant, a notice revoking the extension of time for
submission of data. Such data shall instead be due in
accordance with the date established by the Administrator
for the submission of the data.
(vii) If the registrant does not commit to support a
specific minor use of the pesticide, but is supporting and
providing data in a timely and adequate fashion to support uses
of the pesticide on a food, or if all uses of the pesticide are
nonfood uses and the registrant does not commit to support a
specific minor use of the pesticide but is supporting and
providing data in a timely and adequate fashion to support other
nonfood uses of the pesticide, the Administrator, at the written
request of the registrant, shall not take any action pursuant to
this clause in regard to such unsupported minor use until the
final deadline established as of August 3, 1996, for the
submission of data under section 136a-1 of this title for the
supported uses identified pursuant to this clause unless the
Administrator determines that the absence of the data is
significant enough to cause human health or environmental
concerns. On the basis of such determination, the Administrator
may refuse the request for extension by the registrant. Upon
receipt of the request from the registrant, the Administrator
shall publish in the Federal Register a notice of the receipt of
the request and the effective date upon which the uses not being
supported will be voluntarily deleted from the registration
pursuant to section 136d(f)(1) of this title. If the
Administrator grants an extension under this clause, the
Administrator shall monitor the development of the data for the
uses being supported and shall ensure that the registrant is
meeting the schedule for the production of such data. If the
Administrator determines that the registrant is not meeting or
has not met the schedule for the production of such data, the
Administrator may proceed in accordance with clause (iv) of this
subparagraph regarding the continued registration of the
affected products with the minor and other uses and shall inform
the public of such action in accordance with section 136d(f)(2)
of this title. Notwithstanding the provisions of this clause,
the Administrator may deny, modify, or revoke the temporary
extension under this subparagraph if the Administrator
determines that the continuation of the minor use may cause an
unreasonable adverse effect on the environment. In the event of
modification or revocation, the Administrator shall provide, in
writing, to the registrant a notice revoking the temporary
extension and establish a new effective date by which the minor
use shall be deleted from the registration.
(viii)(I) If data required to support registration of a
pesticide under subparagraph (A) is requested by a Federal or
State regulatory authority, the Administrator shall, to the
extent practicable, coordinate data requirements, test
protocols, timetables, and standards of review and reduce
burdens and redundancy caused to the registrant by multiple
requirements on the registrant.
(II) The Administrator may enter into a cooperative
agreement with a State to carry out subclause (I).
(III) Not later than 1 year after August 3, 1996, the
Administrator shall develop a process to identify and assist in
alleviating future disparities between Federal and State data
requirements.
(C) Simplified procedures
Within nine months after September 30, 1978, the
Administrator shall, by regulation, prescribe simplified
procedures for the registration of pesticides, which shall
include the provisions of subparagraph (D) of this paragraph.
(D) Exemption
No applicant for registration of a pesticide 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 application shall be required to--
(i) submit or cite data pertaining to such purchased
product; or
(ii) offer to pay reasonable compensation otherwise
required by paragraph (1)(D) of this subsection for the use
of any such data.
(E) Minor use waiver
In handling the registration of a pesticide for a minor use,
the Administrator may waive otherwise applicable data
requirements if the Administrator determines that the absence of
such data will not prevent the Administrator from determining--
(i) the incremental risk presented by the minor use of
the pesticide; and
(ii) that such risk, if any, would not be an
unreasonable adverse effect on the environment.
(3) Application
(A) In general
The Administrator shall review the data after receipt of the
application and shall, as expeditiously as possible, either
register the pesticide in accordance with paragraph (5), or
notify the applicant of the Administrators determination that
it does not comply with the provisions of the subchapter in
accordance with paragraph (6).
(B) Identical or substantially similar
(i) The Administrator shall, as expeditiously as possible,
review and act on any application received by the Administrator
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 identified in
the application, or that would differ in composition and
labeling from such currently-registered pesticide only in
ways that would not significantly increase 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.
(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 incomplete,
reject the application;
(II) within 90 days after receiving a complete
application, 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.
(C) Minor use registration
(i) The Administrator shall, as expeditiously as possible,
review and act on any complete application--
(I) that proposes the initial registration of a new
pesticide active ingredient if the active ingredient is
proposed to be registered solely for minor uses, or proposes
a registration amendment solely for minor uses to an
existing registration; or
(II) for a registration or a registration amendment that
proposes significant minor uses.
(ii) For the purposes of clause (i)--
(I) the term ``as expeditiously as possible means that
the Administrator shall, to the greatest extent practicable,
complete a review and evaluation of all data, submitted with
a complete application, within 12 months after the
submission of the complete application, and the failure of
the Administrator to complete such a review and evaluation
under clause (i) shall not be subject to judicial review;
and
(II) the term ``significant minor uses means 3 or more
minor uses proposed for every nonminor use, a minor use that
would, in the judgment of the Administrator, serve as a
replacement for any use which has been canceled in the 5
years preceding the receipt of the application, or a minor
use that in the opinion of the Administrator would avoid the
reissuance of an emergency exemption under section 136p of
this title for that minor use.
(D) Adequate time for submission of minor use data
If a registrant makes a request for a minor use waiver,
regarding data required by the Administrator, pursuant to
paragraph (2)(E), and if the Administrator denies in whole or in
part such data waiver request, the registrant shall have a full-
time period for providing such data. For purposes of this
subparagraph, the term ``full-time period means the time
period originally established by the Administrator for
submission of such data, beginning with the date of receipt by
the registrant of the Administrators notice of denial.
(4) Notice of application
The Administrator shall publish in the Federal Register,
promptly after receipt of the statement 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 the
Administrator determines that, when considered with any restrictions
imposed under subsection (d) of this section--
(A) its composition is such as to warrant the proposed
claims for it;
(B) its labeling and other material required to be submitted
comply with the requirements of this subchapter;
(C) it will perform its intended function without
unreasonable adverse effects on the environment; and
(D) when used in accordance with widespread and commonly
recognized practice it will not generally cause unreasonable
adverse effects on the environment.
The Administrator shall not make any lack of essentiality a
criterion for denying registration of any pesticide. Where two
pesticides meet the 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 Administrator
may waive data requirements pertaining to efficacy, in which event
the Administrator may register the pesticide without determining
that the pesticides composition is such as to warrant proposed
claims of efficacy. If a pesticide is found to be efficacious by any
State under section 136v(c) of this title, a presumption is
established that the Administrator shall waive data requirements
pertaining to efficacy for use of the pesticide in such State.
(6) Denial of registration
If the Administrator determines that the requirements of
paragraph (5) for registration are not satisfied, the Administrator
shall notify the applicant for registration of the Administrators
determination and of the Administrators reasons (including the
factual basis) therefor, and that, unless the applicant corrects the
conditions 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, the Administrator shall notify the applicant of the
Administrators decision and of the Administrators 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 136d of this title.
(7) Registration under special circumstances
Notwithstanding 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 identical or
substantially similar to any currently registered pesticide and
use thereof, or differ only in ways that would not significantly
increase the risk of unreasonable adverse effects on the
environment, and (ii) approving the registration or amendment in
the manner proposed by the applicant would not significantly
increase the risk of any unreasonable adverse effect on the
environment. An applicant seeking conditional registration or
amended registration under this subparagraph shall submit such
data as would be required to obtain registration of a similar
pesticide under paragraph (5). If the applicant is unable to
submit an item of data because it has not yet been generated,
the Administrator may register or amend the registration of the
pesticide under such conditions as will require the submission
of such data not later than the time such data are required to
be submitted with respect to similar pesticides already
registered under this subchapter.
(B) The Administrator may conditionally amend the
registration of a pesticide to permit additional uses of such
pesticide notwithstanding that data concerning the pesticide 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 significantly increase the risk of any
unreasonable adverse effect on the environment. Notwithstanding
the foregoing provisions of this subparagraph, no registration
of a pesticide may be amended to permit an additional use of
such pesticide if the Administrator has issued a notice stating
that such pesticide, or any ingredient thereof, meets or exceeds
risk criteria associated in whole or in part with human dietary
exposure enumerated in regulations issued under this subchapter,
and during the pendency of any risk-benefit evaluation initiated
by such notice, if (I) the additional use of such pesticide
involves a major food or feed crop, or (II) the additional use
of such pesticide involves a minor food or feed crop and the
Administrator determines, with the concurrence of the Secretary
of Agriculture, there is available an effective alternative
pesticide that does not meet or exceed such risk criteria. An
applicant seeking amended registration under this subparagraph
shall submit such data as would be required to obtain
registration of a similar pesticide under paragraph (5). If the
applicant is unable to submit an item of data (other than data
pertaining to the proposed additional use) because it has not
yet been generated, the Administrator may amend the registration
under such conditions as will require the submission of such
data not later than the time such data are required to be
submitted with respect to similar pesticides already registered
under this subchapter.
(C) The Administrator may conditionally register a pesticide
containing an active ingredient not contained in any currently
registered pesticide for a period reasonably sufficient for the
generation and submission of required data (which are lacking
because a period reasonably sufficient for generation of the
data has not elapsed since the Administrator first imposed the
data requirement) on the condition that by the end of such
period the Administrator receives such data and the data do not
meet or exceed risk criteria enumerated in regulations issued
under this subchapter, and on such other conditions as the
Administrator may prescribe. A conditional registration under
this subparagraph shall be granted only if the Administrator
determines that use of the pesticide during such period will not
cause any unreasonable adverse effect on the environment, and
that use of the pesticide is in the public interest.
(8) Interim administrative review
Notwithstanding any other provision of this subchapter, 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 subchapter, unless such interim
administrative process is based on a validated test or other
significant evidence raising prudent concerns of unreasonable
adverse risk to man or to the environment. Notice of the definition
of the terms ``validated test and ``other significant evidence
as used herein shall be published by the Administrator in the
Federal Register.
(9) Labeling
(A) Additional statements
Subject to subparagraphs (B) and (C), it shall not be a
violation of this subchapter for a registrant to modify the
labeling of an antimicrobial pesticide product to include
relevant information on product efficacy, product composition,
container composition or design, or other characteristics that
do not relate to any pesticidal claim or pesticidal activity.
(B) Requirements
Proposed labeling information under subparagraph (A) shall
not be false or misleading, shall not conflict with or detract
from any statement required by law or the Administrator as a
condition of registration, and shall be substantiated on the
request of the Administrator.
(C) Notification and disapproval
(i) Notification
A registration may be modified under subparagraph (A)
if--
(I) the registrant notifies the Administrator in
writing not later than 60 days prior to distribution or
sale of a product bearing the modified labeling; and
(II) the Administrator does not disapprove of the
modification under clause (ii).
(ii) Disapproval
Not later than 30 days after receipt of a notification
under clause (i), the Administrator may disapprove the
modification by sending the registrant notification in
writing stating that the proposed language is not acceptable
and stating the reasons why the Administrator finds the
proposed modification unacceptable.
(iii) Restriction on sale
A registrant may not sell or distribute a product
bearing a disapproved modification.
(iv) Objection
A registrant may file an objection in writing to a
disapproval under clause (ii) not later than 30 days after
receipt of notification of the disapproval.
(v) Final action
A decision by the Administrator following receipt and
consideration of an objection filed under clause (iv) shall
be considered a final agency action.
(D) Use dilution
The label or labeling required under this subchapter for an
antimicrobial pesticide that is or may be diluted for use may
have a different statement of caution or protective measures for
use of the recommended diluted solution of the pesticide than
for use of a concentrate of the pesticide if the Administrator
determines that--
(i) adequate data have been submitted to support the
statement proposed for the diluted solution uses; and
(ii) the label or labeling provides adequate protection
for exposure to the diluted solution of the pesticide.
(10) Expedited registration of pesticides
(A) Not later than 1 year after August 3, 1996, the
Administrator shall, utilizing public comment, develop procedures
and guidelines, and expedite the review of an application for
registration of a pesticide or an amendment to a registration that
satisfies such guidelines.
(B) Any application for registration or an amendment, including
biological and conventional pesticides, will be considered for
expedited review under this paragraph. An application for
registration or an amendment shall qualify for expedited review if
use of the pesticide proposed by the application may reasonably be
expected to accomplish 1 or more of the following:
(i) Reduce the risks of pesticides to human health.
(ii) Reduce the risks of pesticides to nontarget organisms.
(iii) Reduce the potential for contamination of groundwater,
surface water, or other valued environmental resources.
(iv) Broaden the adoption of integrated pest management
strategies, or make such strategies more available or more
effective.
(C) The Administrator, not later than 30 days after receipt of
an application for expedited review, shall notify the applicant
whether the application is complete. If it is found to be
incomplete, the Administrator may either reject the request for
expedited review or ask the applicant for additional information to
satisfy the guidelines developed under subparagraph (A).
(d) Classification of pesticides
(1) Classification for general use, restricted use, or both
(A) As a part of the registration of a pesticide the
Administrator shall classify it as being for general use or for
restricted use. If the Administrator determines that some of the
uses for which the pesticide is registered should be for general use
and that other uses for which it is registered should be for
restricted use, the Administrator 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 reregistration. If some of the uses of
the pesticide are classified for general use, and other uses are
classified for restricted use, the directions relating to its
general uses shall be clearly separated and distinguished from those
directions relating to its restricted uses. 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 registered, or for one or
more of such uses, or in accordance with a widespread and commonly
recognized practice, will not generally cause unreasonable adverse
effects on the environment, the Administrator will classify the
pesticide, or the particular use or uses of the pesticide to which
the determination applies, for general use.
(C) If the Administrator determines that the pesticide, when
applied in accordance with its directions for use, warnings and
cautions and for the uses for which it is registered, or for one or
more of such uses, or in accordance with a widespread and commonly
recognized practice, may generally cause, without additional
regulatory restrictions, unreasonable adverse effects on the
environment, including injury to the applicator, the Administrator
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 because of a
determination that the acute dermal or inhalation toxicity of
the pesticide presents a hazard to the applicator or other
persons, the pesticide shall be applied for any use to which the
restricted classification applies only by or under the direct
supervision of a certified applicator.
(ii) If the Administrator classifies a pesticide, or one or
more uses of such pesticide, for restricted use because of a
determination that its use without additional regulatory
restriction may cause unreasonable adverse effects on the
environment, the pesticide shall be applied for any use to which
the determination 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 reviewable in the appropriate court of
appeals upon petition of a person adversely affected filed
within 60 days of the publication of the regulation in final
form.
(2) Change in classification
If the Administrator determines that a change in the
classification of any use of a pesticide from general use to
restricted use is necessary to prevent unreasonable adverse effects
on the environment, the Administrator shall notify the registrant of
such pesticide of such determination at least forty-five days before
making the change and shall publish the proposed change in the
Federal Register. The registrant, or other interested person with
the concurrence of the registrant, may seek relief from such
determination under section 136d(b) of this title.
(3) Change in classification from restricted use to general
use
The registrant of any pesticide with one or more uses classified
for restricted use may petition the Administrator to change any such
classification from restricted to general use. Such petition shall
set out the basis for the registrants position that restricted use
classification is unnecessary because classification of the
pesticide for general use would not cause unreasonable adverse
effects on the environment. The Administrator, within sixty days
after receiving such petition, shall notify the registrant whether
the petition has been granted or denied. Any denial shall contain an
explanation therefor and any such denial shall be subject to
judicial review under section 136n of this title.
(e) Products with same formulation and claims
Products which have the same formulation, are manufactured by the
same person, the labeling of which contains the same claims, and the
labels of which bear a designation identifying the product as the same
pesticide may be registered as a single pesticide; and additional names
and labels shall be added to the registration by supplemental
statements.
(f) Miscellaneous
(1) Effect of change of labeling or formulation
If the labeling or formulation for a pesticide is changed, the
registration shall be amended to reflect such change if the
Administrator determines that the change will not violate any
provision of this subchapter.
(2) Registration not a defense
In no event shall registration of an article be construed as a
defense for the commission of any offense under this subchapter. As
long as no cancellation proceedings are in effect registration of a
pesticide shall be prima facie evidence that the pesticide, its
labeling and packaging comply with the registration provisions of
the subchapter.
(3) Authority to consult other Federal agencies
In connection with consideration of any registration or
application for registration under this section, the Administrator
may consult with any other Federal agency.
(4) Mixtures of nitrogen stabilizers and fertilizer products
Any mixture or other combination of--
(A) 1 or more nitrogen stabilizers registered under this
subchapter; and
(B) 1 or more fertilizer products,
shall not be subject to the provisions of this section or sections
136a-1, 136c, 136e, 136m, and 136o(a)(2) of this title if the
mixture or other combination is accompanied by the labeling required
under this subchapter for the nitrogen stabilizer contained in the
mixture or other combination, the mixture or combination is mixed or
combined in accordance with such labeling, and the mixture or
combination does not contain any active ingredient other than the
nitrogen stabilizer.
(g) Registration review
(1) General rule
(A) Periodic review
The registrations of pesticides are to be periodically
reviewed. The Administrator shall by regulation establish a
procedure for accomplishing the periodic review of
registrations. The goal of these regulations shall be a review
of a pesticides registration every 15 years. No registration
shall be canceled as a result of the registration review process
unless the Administrator follows the procedures and substantive
requirements of section 136d of this title.
(B) Limitation
Nothing in this subsection shall prohibit the Administrator
from undertaking any other review of a pesticide pursuant to
this subchapter.
(2) Data
(A) Submission required
The Administrator shall use the authority in subsection
(c)(2)(B) of this section to require the submission of data when
such data are necessary for a registration review.
(B) Data submission, compensation, and exemption
For purposes of this subsection, the provisions of
subsections (c)(1), (c)(2)(B), and (c)(2)(D) of this section
shall be utilized for and be applicable to any data required for
registration review.
(h) Registration requirements for antimicrobial pesticides
(1) Evaluation of process
To the maximum extent practicable consistent with the degrees of
risk presented by an antimicrobial pesticide and the type of review
appropriate to evaluate the risks, the Administrator shall identify
and evaluate reforms to the antimicrobial registration process that
would reduce review periods existing as of August 3, 1996, for
antimicrobial pesticide product registration applications and
applications for amended registration of antimicrobial pesticide
products, including--
(A) new antimicrobial active ingredients;
(B) new antimicrobial end-use products;
(C) substantially similar or identical antimicrobial
pesticides; and
(D) amendments to antimicrobial pesticide registrations.
(2) Review time period reduction goal
Each reform identified under paragraph (1) shall be designed to
achieve the goal of reducing the review period following submission
of a complete application, consistent with the degree of risk, to a
period of not more than--
(A) 540 days for a new antimicrobial active ingredient
pesticide registration;
(B) 270 days for a new antimicrobial use of a registered
active ingredient;
(C) 120 days for any other new antimicrobial product;
(D) 90 days for a substantially similar or identical
antimicrobial product;
(E) 90 days for an amendment to an antimicrobial
registration that does not require scientific review of data;
and
(F) 90 to 180 days for an amendment to an antimicrobial
registration that requires scientific review of data and that is
not otherwise described in this paragraph.
(3) Implementation
(A) Proposed rulemaking
(i) Issuance
Not later than 270 days after August 3, 1996, the
Administrator shall publish in the Federal Register proposed
regulations to accelerate and improve the review of
antimicrobial pesticide products designed to implement, to
the extent practicable, the goals set forth in paragraph
(2).
(ii) Requirements
Proposed regulations issued under clause (i) shall--
(I) define the various classes of antimicrobial use
patterns, including household, industrial, and
institutional disinfectants and sanitizing pesticides,
preservatives, water treatment, and pulp and paper mill
additives, and other such products intended to
disinfect, sanitize, reduce, or mitigate growth or
development of microbiological organisms, or protect
inanimate objects, industrial processes or systems,
surfaces, water, or other chemical substances from
contamination, fouling, or deterioration caused by
bacteria, viruses, fungi, protozoa, algae, or slime;
(II) differentiate the types of review undertaken
for antimicrobial pesticides;
(III) conform the degree and type of review to the
risks and benefits presented by antimicrobial pesticides
and the function of review under this subchapter,
considering the use patterns of the product, toxicity,
expected exposure, and product type;
(IV) ensure that the registration process is
sufficient to maintain antimicrobial pesticide efficacy
and that antimicrobial pesticide products continue to
meet product performance standards and effectiveness
levels for each type of label claim made; and
(V) implement effective and reliable deadlines for
process management.
(iii) Comments
In developing the proposed regulations, the
Administrator shall solicit the views from registrants and
other affected parties to maximize the effectiveness of the
rule development process.
(B) Final regulations
(i) Issuance
The Administrator shall issue final regulations not
later than 240 days after the close of the comment period
for the proposed regulations.
(ii) Failure to meet goal
If a goal described in paragraph (2) is not met by the
final regulations, the Administrator shall identify the
goal, explain why the goal was not attained, describe the
element of the regulations included instead, and identify
future steps to attain the goal.
(iii) Requirements
In issuing final regulations, the Administrator shall--
(I) consider the establishment of a certification
process for regulatory actions involving risks that can
be responsibly managed, consistent with the degree of
risk, in the most cost-efficient manner;
(II) consider the establishment of a certification
process by approved laboratories as an adjunct to the
review process;
(III) use all appropriate and cost-effective review
mechanisms, including--
(aa) expanded use of notification and non-
notification procedures;
(bb) revised procedures for application review;
and
(cc) allocation of appropriate resources to
ensure streamlined management of antimicrobial
pesticide registrations; and
(IV) clarify criteria for determination of the
completeness of an application.
(C) Expedited review
This subsection does not affect the requirements or extend
the deadlines or review periods contained in subsection (c)(3)
of this section.
(D) Alternative review periods
If the final regulations to carry out this paragraph are not
effective 630 days after August 3, 1996, until the final
regulations become effective, the review period, beginning on
the date of receipt by the Agency of a complete application,
shall be--
(i) 2 years for a new antimicrobial active ingredient
pesticide registration;
(ii) 1 year for a new antimicrobial use of a registered
active ingredient;
(iii) 180 days for any other new antimicrobial product;
(iv) 90 days for a substantially similar or identical
antimicrobial product;
(v) 90 days for an amendment to an antimicrobial
registration that does not require scientific review of
data; and
(vi) 240 days for an amendment to an antimicrobial
registration that requires scientific review of data and
that is not otherwise described in this subparagraph.
(E) Wood preservatives
An application for the registration, or for an amendment to
the registration, of a wood preservative product for which a
claim of pesticidal activity listed in section 136(mm) of this
title is made (regardless of any other pesticidal claim that is
made with respect to the product) shall be reviewed by the
Administrator within the same period as that established under
this paragraph for an antimicrobial pesticide product
application, consistent with the degree of risk posed by the use
of the wood preservative product, if the application requires
the applicant to satisfy the same data requirements as are
required to support an application for a wood preservative
product that is an antimicrobial pesticide.
(F) Notification
(i) In general
Subject to clause (iii), the Administrator shall notify
an applicant whether an application has been granted or
denied not later than the final day of the appropriate
review period under this paragraph, unless the applicant and
the Administrator agree to a later date.
(ii) Final decision
If the Administrator fails to notify an applicant within
the period of time required under clause (i), the failure
shall be considered an agency action unlawfully withheld or
unreasonably delayed for purposes of judicial review under
chapter 7 of title 5.
(iii) Exemption
This subparagraph does not apply to an application for
an antimicrobial pesticide that is filed under subsection
(c)(3)(B) of this section prior to 90 days after August 3,
1996.
(4) Annual report
(A) Submission
Beginning on August 3, 1996, and ending on the date that the
goals under paragraph (2) are achieved, the Administrator shall,
not later than March 1 of each year, prepare and submit an
annual report to the Committee on Agriculture of the House of
Representatives and the Committee on Agriculture, Nutrition, and
Forestry of the Senate.
(B) Requirements
A report submitted under subparagraph (A) shall include a
description of--
(i) measures taken to reduce the backlog of pending
registration applications;
(ii) progress toward achieving reforms under this
subsection; and
(iii) recommendations to improve the activities of the
Agency pertaining to antimicrobial registrations.
(June 25, 1947, ch. 125, Sec. 3, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 979; amended Pub. L. 94-140, Sec. 12, Nov. 28, 1975,
89 Stat. 755; Pub. L. 95-396, Secs. 2(a), 3-8, Sept. 30, 1978, 92 Stat.
820, 824-827; Pub. L. 100-532, title I, Secs. 102(b), 103, title VI,
Sec. 601(b)(1), title VIII, Sec. 801(b), Oct. 25, 1988, 102 Stat. 2667,
2677, 2680; Pub. L. 101-624, title XIV, Sec. 1492, Nov. 28, 1990, 104
Stat. 3628; Pub. L. 102-237, title X, Sec. 1006(a)(3), (b)(1), (2), (c),
Dec. 13, 1991, 105 Stat. 1894-1896; Pub. L. 104-170, title I,
Secs. 105(b), 106(b), title II, Secs. 210(b), (c)(1), (d), (e), (f)(2),
222-224, 231, 250, Aug. 3, 1996, 110 Stat. 1491, 1494-1497, 1499, 1503,
1504, 1508, 1510.)
Prior Provisions
A prior section 3 of act June 25, 1947, was classified to section
135a of this title prior to amendment of act June 25, 1947, by Pub. L.
92-516.
Amendments
1996--Subsec. (c)(1)(F)(ii) to (vi). Pub. L. 104-170, Sec. 210(b),
added cls. (ii), (v), and (vi), redesignated former cls. (ii) and (iii)
as (iii) and (iv), respectively, and in cl. (iv) substituted ``(i),
(ii), and (iii) for ``(i) and (ii).
Subsec. (c)(1)(G). Pub. L. 104-170, Sec. 250(1), added subpar. (G).
Subsec. (c)(2)(A). Pub. L. 104-170, Secs. 210(d)(1), 231, inserted
heading, inserted ``the public health and agricultural need for such
minor use, after ``pattern of use,, and substituted ``potential
beneficial or adverse effects on man and the environment for
``potential exposure of man and the environment to the pesticide.
Subsec. (c)(2)(B). Pub. L. 104-170, Sec. 210(d)(2), inserted
heading.
Subsec. (c)(2)(B)(vi). Pub. L. 104-170, Sec. 210(c)(1), added cl.
(vi).
Subsec. (c)(2)(B)(vii). Pub. L. 104-170, Sec. 210(f)(2), added cl.
(vii).
Subsec. (c)(2)(B)(viii). Pub. L. 104-170, Sec. 222, added cl.
(viii).
Subsec. (c)(2)(C). Pub. L. 104-170, Sec. 210(d)(3), inserted
heading.
Subsec. (c)(2)(E). Pub. L. 104-170, Sec. 210(d)(4), added subpar.
(E).
Subsec. (c)(3)(A), (B). Pub. L. 104-170, Sec. 210(e)(1), (2),
inserted headings.
Subsec. (c)(3)(C), (D). Pub. L. 104-170, Sec. 210(e)(3), added
subpars. (C) and (D).
Subsec. (c)(9). Pub. L. 104-170, Sec. 223, added par. (9).
Subsec. (c)(10). Pub. L. 104-170, Sec. 250(2), added par. (10).
Subsec. (f)(4). Pub. L. 104-170, Sec. 105(b), added par. (4).
Subsec. (g). Pub. L. 104-170, Sec. 106(b), added subsec. (g).
Subsec. (h). Pub. L. 104-170, Sec. 224, added subsec. (h).
1991--Subsec. (c)(1)(D). Pub. L. 102-237, Sec. 1006(a)(3)(B), (C),
added subpar. (D) and redesignated former subpar. (D) as (F).
Subsec. (c)(1)(E). Pub. L. 102-237, Sec. 1006(a)(3)(A), (C), added
subpar. (E) and struck out former subpar. (E) which read as follows:
``the complete formula of the pesticide; and.
Subsec. (c)(1)(F). Pub. L. 102-237, Sec. 1006(a)(3)(A), (B), (D),
redesignated former subpar. (D) as (F), in cl. (i) substituted ``With
for ``with and a period for semicolon at end, in cl. (ii) substituted
``Except for ``except and a period for semicolon at end, in cl.
(iii) substituted ``After for ``after and a period for semicolon at
end, and struck out former subpar. (F) which read as follows: ``a
request that the pesticide be classified for general use, for restricted
use, or for both.
Subsec. (c)(2)(A). Pub. L. 102-237, Sec. 1006(b)(1), (2),
substituted ``the Administrator for ``he before ``requires,
``shall permit, ``shall make, and ``deems, and substituted ``the
Administrators for ``his.
Subsec. (c)(2)(D). Pub. L. 102-237, Sec. 1006(c), clarified
amendment made by Pub. L. 100-532, Sec. 102(b)(2)(A). See 1988 Amendment
note below.
Subsec. (c)(3)(A). Pub. L. 102-237, Sec. 1006(b)(2), substituted
``the Administrators for ``his.
Subsec. (c)(5). Pub. L. 102-237, Sec. 1006(b)(1), substituted ``the
Administrator for ``he before ``determines.
Subsec. (c)(6). Pub. L. 102-237, Sec. 1006(b)(1), (2), substituted
``the Administrator for ``he before ``shall notify in two places
and ``the Administrators for ``his in four places.
Subsec. (d)(1). Pub. L. 102-237, Sec. 1006(b)(1), substituted ``the
Administrator for ``he before ``shall classify it for both in
subpar. (A), before ``will classify in subpar. (B), and before ``shall
classify in subpar. (C).
Subsec. (d)(2). Pub. L. 102-237, Sec. 1006(b)(1), substituted ``the
Administrator for ``he before ``shall notify.
1990--Subsec. (c)(2)(A). Pub. L. 101-624 inserted after third
sentence ``The Administrator shall not require a person to submit, in
relation to a registration or reregistration of a pesticide for minor
agricultural use under this subchapter, any field residue data from a
geographic area where the pesticide will not be registered for such
use.
1988--Subsec. (a). Pub. L. 100-532, Sec. 601(b)(1), substituted
``Requirement of registration for ``Requirement in heading and
amended text generally. Prior to amendment, text read as follows:
``Except as otherwise provided by this subchapter, no person in any
State may distribute, sell, offer for sale, hold for sale, ship, deliver
for shipment, or receive and (having so received) deliver or offer to
deliver, to any person any pesticide which is not registered with the
Administrator.
Subsec. (c)(1)(D). Pub. L. 100-532, Sec. 801(b)(1)-(4), in
introductory provisions, substituted ``paragraph (2)(D) for
``subsection (c)(2)(D) of this section, in cl. (i), substituted ``(i)
with for ``(i) With and ``, except that for ``: Provided, That,
in cl. (ii), substituted ``clause (i) for ``subparagraph (D)(i) of
this paragraph, and in cl. (iii), substituted ``clauses (i) and (ii)
for ``subparagraphs (D)(i) and (D)(ii) of this paragraph.
Subsec. (c)(2)(A). Pub. L. 100-532, Sec. 801(b)(5)(A), (B),
substituted ``(2) Data in support of registration.--
``(A) The
for ``(2)(A) Data in support of registration.--The, and directed that
subpar. (A) be aligned with left margin of subsec. (d)(1)(A) of this
section.
Subsec. (c)(2)(B). Pub. L. 100-532, Secs. 102(b)(1), 801(b)(5)(C)-
(F), substituted ``(B)(i) If for ``(B) Additional data to support
existing registration.--(i) If, directed that cls. (ii) to (v) be
aligned with left margin of subpar. (A), in cls. (ii) and (iii),
inserted ``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., in cl. (iv), substituted ``title. The only for ``title:
Provided, that the only, and in cl. (v), substituted ``paragraph
(1)(D) for ``subsection (c)(1)(D) of this section.
Subsec. (c)(2)(C). Pub. L. 100-532, Sec. 801(b)(5)(G), (H), struck
out ``Simplified procedures after ``(C) and directed that text be
aligned with left margin of subpar. (A).
Subsec. (c)(2)(D). Pub. L. 100-532, Sec. 102(b)(2)(A), and Pub. L.
102-237, Sec. 1006(c), substituted ``the pesticide that is the subject
of the application for ``an end-use product.
Subsec. (c)(2)(D)(i). Pub. L. 100-532, Sec. 102(b)(2)(B), struck out
``the safety of after ``data pertaining to.
Subsec. (c)(3). Pub. L. 100-532, Sec. 103, substituted ``(A) The
Administrator for ``The Administrator and added subpar. (B).
Subsec. (c)(7). Pub. L. 100-532, Sec. 801(b)(6), in introductory
provisions, substituted ``paragraph (5) for ``subsection (c)(5) of
this section, in subpars. (A) and (B), substituted ``paragraph (5).
If for ``subsection (c)(5) of this section: Provided, That, if, and
in subpar. (C), substituted ``prescribe. A for ``prescribe: Provided,
that a.
Subsec. (d)(1)(A). Pub. L. 100-532, Sec. 801(b)(7), substituted
``restricted use. If for ``restricted use, provided that if and
``restricted uses. The Administrator for ``restricted uses: Provided,
however, That the Administrator.
Subsec. (f)(2). Pub. L. 100-532, Sec. 801(b)(8), substituted ``this
subchapter. As for ``this subchapter: Provided, That as.
Subsec. (g). Pub. L. 100-532, Sec. 801(b)(9), struck out subsec. (g)
which read as follows: ``The Administrator shall accomplish the
reregistration of all pesticides in the most expeditious manner
practicable: Provided, That, to the extent appropriate, any pesticide
that results in a postharvest residue in or on food or feed crops shall
be given priority in the reregistration process.
1978--Subsec. (c)(1)(D). Pub. L. 95-396, Sec. 2(a)(1), added subpar.
(D), and struck out provisions which required the applicant for
registration of a pesticide to file with the Administrator a statement
containing ``if requested by the Administrator, a full description of
the tests made and the results thereof upon which the claims are based,
except that data submitted on or after January 1, 1970, in support of an
application shall not, without permission of the applicant, be
considered by the Administrator in support of any other application for
registration unless such other applicant shall have first offered to pay
reasonable compensation for producing the test data to be relied upon
and such data is not protected from disclosure by section 136h(b) of
this title. This provision with regard to compensation for producing the
test data to be relied upon shall apply with respect to all applications
for registration or reregistration submitted on or after October 21,
1972. If the parties cannot agree on the amount and method of payment,
the Administrator shall make such determination and may fix such other
terms and conditions as may be reasonable under the circumstances. The
Administrators determination shall be made on the record after notice
and opportunity for hearing. If either party does not agree with said
determination, he may, within thirty days, take an appeal to the Federal
district court for the district in which he resides with respect to
either the amount of the payment or the terms of payment, or both.
Registration shall not be delayed pending the determination of
reasonable compensation between the applicants, by the Administrator or
by the court..
Subsec. (c)(2). Pub. L. 95-396, Secs. 2(a)(2)(A)-(D), 3, 4,
designated existing provisions as subpar. (A), inserted in second
sentence ``under subparagraph (B) of this paragraph after ``kind of
information, struck out from introductory text of third sentence
``subsection (c)(1)(D) of this section and after ``Except as provided
by, and inserted provisions relating to establishment of standards for
data requirements for registration of pesticides with respect to minor
uses and consideration of economic factors in development of standards
and cost of development, and added subpars. (B) to (D).
Subsec. (c)(5). Pub. L. 95-396, Sec. 5, provided for waiver of data
requirements pertaining to efficacy.
Subsec. (c)(7), (8). Pub. L. 95-396, Sec. 6, added pars. (7) and
(8).
Subsec. (d)(1)(A). Pub. L. 95-396, Sec. 7(1), authorized
classification of pesticide uses by regulation on the initial
classification and registered pesticides prior to reregistration.
Subsec. (d)(2). Pub. L. 95-396, Sec. 7(2), substituted ``forty-five
days for ``30 days.
Subsec. (d)(3). Pub. L. 95-396, Sec. 7(3), added par. (3).
Subsec. (g). Pub. L. 95-396, Sec. 8, added subsec. (g).
1975--Subsec. (c)(1)(D). Pub. L. 94-140 inserted exception relating
to test data submitted on or after January 1, 1970, in support of
application, inserted provision that compensation for producing test
data shall apply to all applications submitted on or after October 21,
1972, and provision relating to delay of registration pending
determination of reasonable compensation, struck out requirement that
payment determined by court not be less than amount determined by
Administrator, and substituted ``If either party for ``If the owner of
the test data.
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Effective Date of 1978 Amendment
Section 2(b) of Pub. L. 95-396 provided that: ``The amendment to
section 3(c)(1)(D) of the Federal Insecticide, Fungicide, and
Rodenticide Act [subsec. (c)(1)(D) of this section] made by [subsec.
(a)(1) of] this section shall apply with respect to all applications for
registration approved after the date of enactment of this Act [Sept. 30,
1978].
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Biological Pesticide Handling Study
Section 1498 of Pub. L. 101-624 provided that:
``(a) Study.--Not later than September 30, 1992, the National
Academy of Sciences shall conduct a study of the biological control
programs and registration procedures utilized by the Food and Drug
Administration, the Animal and Plant Health Inspection Service, and the
Environmental Protection Agency.
``(b) Development of Procedures.--Not later than 1 year after the
completion of the study under subsection (a), the agencies and offices
described in such subsection shall develop and implement a common
process for reviewing and approving biological control applications that
are submitted to such agencies and offices that shall be based on the
study conducted under such subsection and the recommendation of the
National Academy of Sciences, and other public comment.
Education, Study, and Report
Pub. L. 100-478, title I, Sec. 1010, Oct. 7, 1988, 102 Stat. 2313,
provided that:
``(a) Education.--The Administrator of the Environmental Protection
Agency in cooperation with the Secretary of Agriculture and the
Secretary of the Interior, promptly upon enactment of this Act [Oct. 7,
1988], shall conduct a program to inform and educate fully persons
engaged in agricultural food and fiber commodity production of any
proposed pesticide labeling program or requirements that may be imposed
by the Administrator in compliance with the Endangered Species Act (16
U.S.C. 1531 et seq.). The Administrator also shall provide the public
with notice of, and opportunity for comment on, the elements of any such
program and requirements based on compliance with the Endangered Species
Act, including (but not limited to) an identification of any pesticides
affected by the program; an explanation of the restriction or
prohibition on the user or applicator of any such pesticide; an
identification of those geographic areas affected by any pesticide
restriction or prohibition; an identification of the effects of any
restricted or prohibited pesticide on endangered or threatened species;
and an identification of the endangered or threatened species along with
a general description of the geographic areas in which such species are
located wherein the application of a pesticide will be restricted,
prohibited, or its use otherwise limited, unless the Secretary of the
Interior determines that the disclosure of such information may create a
substantial risk of harm to such species or its habitat.
``(b) Study.--The Administrator of the Environmental Protection
Agency, jointly with the Secretary of Agriculture and the Secretary of
the Interior, shall conduct a study to identify reasonable and prudent
means available to the Administrator to implement the endangered species
pesticides labeling program which would comply with the Endangered
Species Act of 1973, as amended, and which would allow persons to
continue production of agricultural food and fiber commodities. Such
study shall include investigation by the Administrator of the best
available methods to develop maps and the best available alternatives to
mapping as means of identifying those circumstances in which use of
pesticides may be restricted; identification of alternatives to
prohibitions on pesticide use, including, but not limited to,
alternative pesticides and application methods and other agricultural
practices which can be used in lieu of any pesticides whose use may be
restricted by the labeling program; examination of methods to improve
coordination among the Environmental Protection Agency, Department of
Agriculture, and Department of the Interior in administration of the
labeling program; and analysis of the means of implementing the
endangered species pesticides labeling program or alternatives to such a
program, if any, to promote the conservation of endangered or threatened
species and to minimize the impacts to persons engaged in agricultural
food and fiber commodity production and other affected pesticide users
and applicators.
``(c) Report.--The Administrator of the Environmental Protection
Agency in cooperation with the Secretary of Agriculture and the
Secretary of the Interior shall submit a report within one year of the
date of enactment of this Act [Oct. 7, 1988], presenting the results of
the study conducted pursuant to subsection (b) of this section to the
Committee on Merchant Marine and Fisheries and the Committee on
Agriculture of the United States House of Representatives, and the
Committee on Environment and Public Works and the Committee on
Agriculture, Nutrition, and Forestry of the United States Senate.
Section Referred to in Other Sections
This section is referred to in sections 136, 136a-1, 136c, 136d,
136h, 136i-1, 136j, 136k, 136l, 136m, 136o, 136q, 136v, 136w-7 of this
title; title 21 section 346a; title 42 section 300j-13.
Sec. 136a-1. Reregistration of registered pesticides
(a) General rule
The Administrator shall reregister, in accordance 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 Administrator has determined, after November
1, 1984, and before the effective date of this section, that--
(1) there are no outstanding data requirements; and
(2) the requirements of section 136a(c)(5) of this title 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 this section of the active ingredients of the pesticides that
will be reregistered.
(2) The second phase shall include the submission to the
Administrator under subsection (d) of this section of notices by
registrants respecting 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 inadequate data within the applicable time period.
(3) The third phase shall include submission to the
Administrator by registrants of the information required under
subsection (e) of this section.
(4) The fourth phase shall include an independent, initial
review by the Administrator under subsection (f) of this section of
submissions 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
Administrator under subsection (g) of this section of data submitted
for reregistration and appropriate regulatory action by the
Administrator.
(c) Phase one
(1) Priority for reregistration
For purposes of the reregistration of the pesticides described
in subsection (a) of this section, the Administrator 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) that--
(A) are in use on or in food or feed and may result in
postharvest residues;
(B) may result in residues of potential toxicological
concern in potable ground water, edible fish, or shellfish;
(C) have been determined by the Administrator before the
effective date of this section 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, list pesticide active ingredients 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) not 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 Administrator 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 Administrator shall send by certified mail
to the registrants of the pesticides containing such active
ingredients a notice of the time by which the registrants are to
notify the Administrator under subsection (d) of this section
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) of
this section shall submit to the Administrator, within the time
period prescribed by paragraph (4), the notice described in
paragraph (2) and any information, commitment, or offer described in
paragraph (3).
(2) Notice of intent to seek or not to seek reregistration
(A) The registrant of a pesticide containing an active
ingredient listed under subparagraph (B), (C), or (D) of subsection
(c)(2) of this section 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 pesticide that contains an active
ingredient listed under subparagraph (B), (C), or (D) of subsection
(c)(2) of this section and for which the registrant 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
Administrator under section 136a of this title, an
identification of--
(i) all data that are required by regulation to support
the registration of the pesticide with respect to such
active ingredient;
(ii) data that were submitted by the registrant
previously 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 identified under
subparagraph (A)(iii) within the applicable time period
prescribed by paragraph (4)(B); 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 136a(c)(2)(B) of this title with regard
to such cost sharing.
For purposes of a submission by a registrant under subparagraph
(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)(1)(G) of this section
that the registrant possesses or has access to the raw data used in
or generated by such study. For purposes of a submission by a
registrant 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 satisfaction of
the Administrator that such data should be considered 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
ingredient listed under subsection (c)(2)(B) of this section,
not later than 3 months after the date of publication of the
listing of such active ingredient;
(ii) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(C) of this section,
not later than 3 months after the date of publication of the
listing of such active ingredient; and
(iii) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(D) of this section,
not later than 3 months after the date of publication of the
listing of such active ingredient.
On application, the Administrator may extend a time period
prescribed by this subparagraph if the Administrator determines that
factors beyond the control of the registrant 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 time, as determined by the Administrator, 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 prescribed 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. Upon application of a registrant, the
Administrator shall, in the case of a minor use, extend the deadline
for the production of residue chemistry data under this subparagraph
for data required solely to support that minor use until the final
deadline for submission of data under this section for the other
uses of the pesticide established as of August 3, 1996, if--
(i) the data to support other uses of the pesticide on a
food are being provided;
(ii) the registrant, in submitting a request for such an
extension provides a schedule, including interim dates to
measure progress, to assure that the data production will be
completed before the expiration of the extension period;
(iii) the Administrator has determined that such extension
will not significantly delay the Administrators schedule for
issuing a reregistration eligibility determination required
under this section; and
(iv) the Administrator has determined that based on existing
data, such extension would not significantly increase the risk
of any unreasonable adverse effect on the environment. If the
Administrator grants an extension under this subparagraph, the
Administrator shall monitor the development of the data and
shall ensure that the registrant is meeting the schedule for the
production of the data. If the Administrator determines that the
registrant is not meeting or has not met the schedule for the
production of such data, the Administrator may proceed in
accordance with clause (iv) of section 136a(c)(2)(B) of this
title or other provisions of this section, as appropriate,
regarding the continued registration of the affected products
with the minor use and shall inform the public of such action.
Notwithstanding the provisions of this subparagraph, the
Administrator may take action to modify or revoke the extension
under this subparagraph if the Administrator determines that the
extension for the minor use may cause an unreasonable adverse
effect on the environment. In such circumstance, the
Administrator shall provide written notice to the registrant
revoking the extension of time for submission of data. Such data
shall instead be due in accordance with the date then
established by the Administrator for submission of the data.
(5) Cancellation and removal
(A) If the registrant of a pesticide does not submit a notice
under paragraph (2) or (3) within the time prescribed by paragraph
(4)(A), the Administrator shall issue a notice of intent to cancel
the registration of such registrant 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) of this section
notifies the Administrator under paragraph (2) that the
registrant intends to seek reregistration of any pesticide
containing 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 described in clauses (ii)
and (iii) of paragraph (3)(A);
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) of this section and a notice of intent to
cancel the registrations of all pesticides containing such active
ingredient and shall provide 60 days for comment on such notice.
(ii) After the 60-day period has expired, the Administrator, 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 furnishes a
notice of intent to reregister the pesticide in accordance with
paragraph (2); and
(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)(1) of
this section has been paid.
(6) Suspensions and penalties
The Administrator shall issue a notice of intent to suspend the
registration of a pesticide in accordance with the procedures
prescribed by section 136a(c)(2)(B)(iv) of this title 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 (3)(B) within the time period
prescribed by paragraph (4)(B) or (B) the registrant has not
submitted such data to the Administrator within such time period. If
the registrant does not commit to support a specific minor use of
the pesticide, but is supporting and providing data in a timely and
adequate fashion to support uses of the pesticide on a food, or if
all uses of the pesticide are nonfood uses and the registrant does
not commit to support a specific minor use of the pesticide but is
supporting and providing data in a timely and adequate fashion to
support other nonfood uses of the pesticide, the Administrator, at
the written request of the registrant, shall not take any action
pursuant to this paragraph in regard to such unsupported minor use
until the final deadline established as of August 3, 1996, for the
submission of data under this section for the supported uses
identified pursuant to this paragraph unless the Administrator
determines that the absence of the data is significant enough to
cause human health or environmental concerns. On such a
determination the Administrator may refuse the request for extension
by the registrant. Upon receipt of the request from the registrant,
the Administrator shall publish in the Federal Register a notice of
the receipt of the request and the effective date upon which the
uses not being supported will be voluntarily deleted from the
registration pursuant to section 136d(f)(1) of this title. If the
Administrator grants an extension under this paragraph, the
Administrator shall monitor the development of the data for the uses
being supported and shall ensure that the registrant is meeting the
schedule for the production of such data. If the Administrator
determines that the registrant is not meeting or has not met the
schedule for the production of such data, the Administrator may
proceed in accordance with section 136a(c)(2)(B)(iv) of this title
regarding the continued registration of the affected products with
the minor and other uses and shall inform the public of such action
in accordance with section 136d(f)(2) of this title. Notwithstanding
this subparagraph, the Administrator may deny, modify, or revoke the
temporary extension under this paragraph if the Administrator
determines that the continuation of the minor use may cause an
unreasonable adverse effect on the environment. In the event of
modification or revocation, the Administrator shall provide, in
writing, to the registrant a notice revoking the temporary extension
and establish a new effective date by which the minor use shall be
deleted from the registration.
(e) Phase three
(1) Information about studies
Each registrant of a pesticide that contains an active
ingredient listed under subparagraph (B), (C), or (D) of subsection
(c)(2) of this section who has submitted a notice under subsection
(d)(2) of this section of an intent to seek the reregistration 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 ingredient
previously submitted by the registrant in support of the
registration of a pesticide containing such active ingredient
and considered by the registrant to be adequate to meet the
requirements of section 136a of this title and the regulations
issued under such section;
(B) a summary of each study concerning the active ingredient
previously submitted by the registrant in support of the
registration of a pesticide containing such active ingredient
that may not comply with the requirements of section 136a of
this title 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 concerning chronic
dosing, oncogenicity, reproductive effects, mutagenicity,
neurotoxicity, teratogenicity, or residue chemistry of the
active ingredient that were submitted to the Administrator
before January 1, 1982;
(D) where data described in subparagraph (C) are not
required for the active ingredient by regulations issued under
section 136a of this title, 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 136a of this title
and the regulations issued under such section;
(E) an identification of data that are required to be
submitted to the Administrator under section 136d(a)(2) of this
title, indicating 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 Administrator
possesses or has access to the raw data used in or generated by
the studies that the registrant summarized under subparagraph
(A) or (B);
(H) either--
(i) a commitment to submit data to fill each outstanding
data requirement identified by the registrant; or
(ii) an offer to share in the cost of developing such
data to be incurred by a person who has made a commitment
under clause (i) to submit such data, and an offer to submit
to arbitration as described by section 136a(c)(2)(B) of this
title with regard to such cost sharing; and
(I) evidence of compliance with section 136a(c)(1)(D)(ii)
\1\ of this title and regulations issued thereunder with regard
to previously submitted data as if the registrant were now
seeking the original registration of the pesticide.
---------------------------------------------------------------------------
\1\ See References in Text note below.
A registrant who submits a certification under subparagraph (G) that
is false shall be considered to have violated this subchapter and
shall be subject to the penalties prescribed by section 136l of this
title.
(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
ingredient listed under subsection (c)(2)(B) of this section,
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
ingredient listed under subsection (c)(2)(C) of this section,
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
ingredient listed under subsection (c)(2)(D) of this section,
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 Administrator, but not more
than 48 months after the date the registrant submitted the
commitment under such paragraph. The Administrator, on application
of a registrant, may extend the period prescribed 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. Upon application of a
registrant, the Administrator shall, in the case of a minor use,
extend the deadline for the production of residue chemistry data
under this subparagraph for data required solely to support that
minor use until the final deadline for submission of data under this
section for the other uses of the pesticide established as of August
3, 1996, if--
(i) the data to support other uses of the pesticide on a
food are being provided;
(ii) the registrant, in submitting a request for such an
extension provides a schedule, including interim dates to
measure progress, to assure that the data production will be
completed before the expiration of the extension period;
(iii) the Administrator has determined that such extension
will not significantly delay the Administrators schedule for
issuing a reregistration eligibility determination required
under this section; and
(iv) the Administrator has determined that based on existing
data, such extension would not significantly increase the risk
of any unreasonable adverse effect on the environment. If the
Administrator grants an extension under this subparagraph, the
Administrator shall monitor the development of the data and
shall ensure that the registrant is meeting the schedule for the
production of the data. If the Administrator determines that the
registrant is not meeting or has not met the schedule for the
production of such data, the Administrator may proceed in
accordance with clause (iv) of section 136a(c)(2)(B) of this
title or other provisions of this section, as appropriate,
regarding the continued registration of the affected products
with the minor use and shall inform the public of such action.
Notwithstanding the provisions of this subparagraph, the
Administrator may take action to modify or revoke the extension
under this subparagraph if the Administrator determines that the
extension for the minor use may cause an unreasonable adverse
effect on the environment. In such circumstance, the
Administrator shall provide written notice to the registrant
revoking the extension of time for submission of data. Such data
shall instead be due in accordance with the date then
established by the Administrator for submission of the data.
(3) Cancellation
(A) If the registrant of a pesticide fails to submit the
information required by paragraph (1) within the time prescribed by
paragraph (2), the Administrator, by order and without hearing,
shall cancel the registration of such pesticide. If the registrant
does not commit to support a specific minor use of the pesticide,
but is supporting and providing data in a timely and adequate
fashion to support uses of the pesticide on a food, or if all uses
of the pesticide are nonfood uses and the registrant does not commit
to support a specific minor use of the pesticide but is supporting
and providing data in a timely and adequate fashion to support other
nonfood uses of the pesticide, the Administrator, at the written
request of the registrant, shall not take any action pursuant to
this subparagraph in regard to such unsupported minor use until the
final deadline established as of August 3, 1996, for the submission
of data under this section for the supported uses identified
pursuant to this subparagraph unless the Administrator determines
that the absence of the data is significant enough to cause human
health or environmental concerns. On the basis of such
determination, the Administrator may refuse the request for
extension by the registrant. Upon receipt of the request from the
registrant, the Administrator shall publish in the Federal Register
a notice of the receipt of the request and the effective date upon
which the uses not being supported will be voluntarily deleted from
the registration pursuant to section 136d(f)(1) of this title. If
the Administrator grants an extension under this subparagraph, the
Administrator shall monitor the development of the data for the uses
being supported and shall ensure that the registrant is meeting the
schedule for the production of such data. If the Administrator
determines that the registrant is not meeting or has not met the
schedule for the production of such data, the Administrator may
proceed in accordance with section 136a(c)(2)(B)(iv) of this title
regarding the continued registration of the affected products with
the minor and other uses and shall inform the public of such action
in accordance with section 136d(f)(2) of this title. Notwithstanding
this subparagraph, the Administrator may deny, modify, or revoke the
temporary extension under this subparagraph if the Administrator
determines that the continuation of the minor use may cause an
unreasonable adverse effect on the environment. In the event of
modification or revocation, the Administrator shall provide, in
writing, to the registrant a notice revoking the temporary extension
and establish a new effective date by which the minor use shall be
deleted from the registration.
(B)(i) If the registrant of a pesticide submits the information
required by paragraph (1) within the time prescribed by paragraph
(2) and such information does not conform to the guidelines for
submissions established by the Administrator, the Administrator
shall determine whether the registrant made a good faith attempt to
conform its submission 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 registrant a reasonable period of
time to make any necessary changes or corrections.
(iii)(I) If the Administrator determines that the registrant 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.
(III) If a hearing is requested, a hearing shall be conducted
under section 136d(d) of this title, except that the only matter for
resolution 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, 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 section 136a of this title
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 required 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)(1) of this section 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 reregistration to submit complete copies of
studies summarized under subsection (e)(1) of this section.
(B) The Administrator shall independently identify and publish
in the Federal Register the outstanding data requirements for each
active ingredient that is listed under subparagraph (B), (C), or (D)
of subsection (c)(2) of this section and that is contained in a
pesticide to be reregistered under this section. The Administrator,
at the same time, shall issue a notice under section 136a(c)(2)(B)
of this title for the submission of the additional 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
ingredient listed under subsection (c)(2)(B) of this section,
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
ingredient listed under subsection (c)(2)(C) of this section,
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
ingredient listed under subsection (c)(2)(D) of this section,
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 reasonable period of
time, as determined by the Administrator, 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 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. Upon
application of a registrant, the Administrator shall, in the case of
a minor use, extend the deadline for the production of residue
chemistry data under this subparagraph for data required solely to
support that minor use until the final deadline for submission of
data under this section for the other uses of the pesticide
established as of August 3, 1996, if--
(i) the data to support other uses of the pesticide on a
food are being provided;
(ii) the registrant, in submitting a request for such an
extension provides a schedule, including interim dates to
measure progress, to assure that the data production will be
completed before the expiration of the extension period;
(iii) the Administrator has determined that such extension
will not significantly delay the Administrators schedule for
issuing a reregistration eligibility determination required
under this section; and
(iv) the Administrator has determined that based on existing
data, such extension would not significantly increase the risk
of any unreasonable adverse effect on the environment. If the
Administrator grants an extension under this subparagraph, the
Administrator shall monitor the development of the data and
shall ensure that the registrant is meeting the schedule for the
production of the data. If the Administrator determines that the
registrant is not meeting or has not met the schedule for the
production of such data, the Administrator may proceed in
accordance with clause (iv) of section 136a(c)(2)(B) of this
title or other provisions of this section, as appropriate,
regarding the continued registration of the affected products
with the minor use and shall inform the public of such action.
Notwithstanding the provisions of this subparagraph, the
Administrator may take action to modify or revoke the extension
under this subparagraph if the Administrator determines that the
extension for the minor use may cause an unreasonable adverse
effect on the environment. In such circumstance, the
Administrator shall provide written notice to the registrant
revoking the extension of time for submission of data. Such data
shall instead be due in accordance with the date then
established by the Administrator for submission of the data.
(3) Suspensions and penalties
The Administrator shall issue a notice of intent to suspend the
registration of a pesticide in accordance with the procedures
prescribed by section 136a(c)(2)(B)(iv) of this title if the
Administrator 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 (1)(B), or (B) progress is insufficient to ensure
submission of the data referred to in clause (A) within the time
period prescribed by paragraph (2)(B) or the required data have not
been submitted to the Administrator within such time period. If the
registrant does not commit to support a specific minor use of the
pesticide, but is supporting and providing data in a timely and
adequate fashion to support uses of the pesticide on a food, or if
all uses of the pesticide are nonfood uses and the registrant does
not commit to support a specific minor use of the pesticide but is
supporting and providing data in a timely and adequate fashion to
support other nonfood uses of the pesticide, the Administrator, at
the written request of the registrant, shall not take any action
pursuant to this paragraph in regard to such unsupported minor use
until the final deadline established as of August 3, 1996, for the
submission of data under this section for the supported uses
identified pursuant to this paragraph unless the Administrator
determines that the absence of the data is significant enough to
cause human health or environmental concerns. On such a
determination the Administrator may refuse the request for extension
by the registrant. Upon receipt of the request from the registrant,
the Administrator shall publish in the Federal Register a notice of
the receipt of the request and the effective date upon which the
uses not being supported will be voluntarily deleted from the
registration pursuant to section 136d(f)(1) of this title. If the
Administrator grants an extension under this paragraph, the
Administrator shall monitor the development of the data for the uses
being supported and shall ensure that the registrant is meeting the
schedule for the production of such data. If the Administrator
determines that the registrant is not meeting or has not met the
schedule for the production of such data, the Administrator may
proceed in accordance with section 136a(c)(2)(B)(iv) of this title
regarding the continued registration of the affected products with
the minor and other uses and shall inform the public of such action
in accordance with section 136d(f)(2) of this title. Notwithstanding
this subparagraph, the Administrator may deny, modify, or revoke the
temporary extension under this paragraph if the Administrator
determines that the continuation of the minor use may cause an
unreasonable adverse effect on the environment. In the event of
modification or revocation, the Administrator shall provide, in
writing, to the registrant a notice revoking the temporary extension
and establish a new effective date by which the minor use shall be
deleted from the registration.
(g) Phase five
(1) Data review
The Administrator shall conduct a thorough examination of all
data submitted under this section concerning an active ingredient
listed under subsection (c)(2) of this section and 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 concerning an
active ingredient of a pesticide under subsection (f) of this
section, the Administrator shall determine whether pesticides
containing such active ingredient are eligible for reregistration.
For extraordinary circumstances, the Administrator may extend such
period for not more than 1 additional year.
(B) Before reregistering a pesticide, the Administrator shall
obtain any needed product-specific data regarding the pesticide by
use of section 136a(c)(2)(B) of this title and shall review such
data within 90 days after its submission. The Administrator 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 Administrator shall
determine whether to reregister a pesticide by determining whether
such pesticide meets the requirements of section 136a(c)(5) of this
title. If the Administrator determines that a pesticide is eligible
to be reregistered, the Administrator 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 determines that
a pesticide should not be reregistered, the Administrator shall take
appropriate regulatory action.
(E) As soon as the Administrator has sufficient information with
respect to the dietary risk of a particular active ingredient, but
in any event no later than the time the Administrator makes a
determination under subparagraph (C) or (D) with respect to
pesticides containing a particular active ingredient, the
Administrator shall--
(i) reassess each associated tolerance and exemption from
the requirement for a tolerance issued under section 408 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a);
(ii) determine whether such tolerance or exemption meets the
requirements of that Act [21 U.S.C. 301 et seq.];
(iii) determine whether additional tolerances or exemptions
should be issued;
(iv) publish in the Federal Register a notice setting forth
the determinations made under this subparagraph; and
(v) commence promptly such proceedings under this subchapter
and section 408 of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 346a] as are warranted by such determinations.
(h) Compensation of data submitter
If data that are submitted by a registrant under subsection (d),
(e), (f), or (g) of this section are used to support the application of
another person under section 136a of this title, the registrant who
submitted such data shall be entitled to compensation for the use of
such data as prescribed by section 136a(c)(1)(D) \2\ of this title. In
determining the amount of such compensation, the fees paid by the
registrant under this section shall be taken into account.
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\2\ See References in Text note below.
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(i) Fees
(1) Initial fee for food or feed use pesticide active
ingredients
The registrants of pesticides that contain an active ingredient
that is listed under subparagraph (B), (C), or (D) of subsection
(c)(2) of this section and that is an active ingredient of any
pesticide registered for a major food or feed use shall collectively
pay a fee of $50,000 on submission of information under paragraphs
(2) and (3) of subsection (d) of this section 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) of
subsection (c)(2) of this section and that is an active ingredient
of any pesticide registered for a major food or feed use shall
collectively pay a fee of $100,000--
(i) on submission of information for such ingredient under
subsection (e)(1) of this section if data are reformatted under
subsection (e)(1)(C) of this section; or
(ii) on submission of data for such ingredient under
subsection (e)(2)(B) of this section if data are not reformatted
under subsection (e)(1)(C) of this section.
(B) The registrants of pesticides that contain an active
ingredient that is listed under subsection (c)(2)(A) of this section
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) of this section 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
Administrator. 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) of this section
and that is not an active ingredient of any pesticide that is
registered 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 time 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 pesticides
that are registered solely for agricultural or nonagricultural minor
uses, or a pesticide the value or volume of use of which is small,
shall be exempt from the fees prescribed by paragraph (3).
(B) The Administrator shall exempt any public health pesticide
from the payment of the fee prescribed under paragraph (3) if, in
consultation with the Secretary of Health and Human Services, the
Administrator determines, based on information supplied by the
registrant, that the economic return to the registrant from sales of
the pesticide does not support the registration or reregistration of
the pesticide.
(C) 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 ``antimicrobial 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 inanimate
objects;
(iv) sterilizers intended to destroy viruses and all living
bacteria, fungi, and their spores on inanimate surfaces; or
(v) fungicides or fungistats.
(D)(i) Notwithstanding any other provision of this subsection,
in the case of a small business registrant of a pesticide, 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 subparagraph.
(ii) If during the 3-year period prior to reregistration the
average annual gross revenue of the registrant from pesticides
containing such active ingredient is--
(I) less than $5,000,000, the registrant shall pay 0.5
percent of such revenue;
(II) $5,000,000 or more but less than $10,000,000, the
registrant shall pay 1 percent of such revenue; or
(III) $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 business
registrant is a corporation, partnership, or unincorporated 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 January 15 of
each year of--
(i) $650 for the first registration; and
(ii) $1,300 for each additional registration, except that no
fee shall be charged for more than 200 registrations held by any
registrant.
(B) In the case of a pesticide that is registered for a minor
agricultural use, the Administrator may reduce or waive the payment
of the fee imposed under this paragraph if the Administrator
determines that the fee would significantly reduce the availability
of the pesticide for the use.
(C)(i) The amount of each fee prescribed under subparagraph (A)
shall be adjusted by the Administrator to a level that will result
in the collection under this paragraph of, to the extent
practicable, an aggregate amount of $17,000,000 fiscal year 2002.\3\
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\3\ So in original.
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(ii) in each of the fiscal years 1998, 1999, and 2000, the
Administrator is authorized to collect up to an additional
$2,000,000 in a manner consistent with subsection (k)(5) of this
section and the recommendations of the Inspector General of the
Environmental Protection Agency. The total fees that may be
collected under this clause shall not exceed $6,000,000.
(D) The maximum annual fee payable under this paragraph by--
(i) a registrant holding not more than 50 pesticide
registrations shall be $55,000; and
(ii) a registrant holding over 50 registrations shall be
$95,000.
(E)(i) For a small business, the maximum annual fee payable
under this paragraph by--
(I) a registrant holding not more than 50 pesticide
registrations shall be $38,500; and
(II) a registrant holding over 50 pesticide registrations
shall be $66,500.
(ii) For purposes of clause (i), the term ``small business
means a corporation, partnership, or unincorporated business that--
(I) has 150 or fewer employees; and
(II) during the 3-year period prior to the most recent
maintenance fee billing cycle, had an average annual gross
revenue from chemicals that did not exceed $40,000,000.
(F) The Administrator shall exempt any public health pesticide
from the payment of the fee prescribed under paragraph (3) if, in
consultation with the Secretary of Health and Humans \4\ Services,
the Administrator determines, based on information supplied by the
registrant, that the economic return to the registrant from sales of
the pesticide does not support the registration or reregistration of
the pesticide.
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\4\ So in original. Probably should be ``Human.
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(G) If any fee prescribed by this paragraph with respect to the
registration of a pesticide is not paid by a registrant by the time
prescribed, the Administrator, by order and without hearing, may
cancel the registration.
(H) The authority provided under this paragraph shall terminate
on September 30, 2002.
(6) Other fees
During the period beginning on October 25, 1988, and ending on
September 30, 2002, the Administrator may not levy any other fees
for the registration of a pesticide under this subchapter 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 ingredient
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 paragraph (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 containing such active
ingredient collectively pay more than 25 percent of the total
active ingredient reregistration fee.
(B) The Administrator, by order, may require any registrant to
submit such reports as the Administrator determines to be necessary
to allow the Administrator to determine and apportion fees under
this subsection, to determine the registrants eligibility for a
reduction or waiver of a fee, or to determine the volume usage for
public health pesticides.
(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 subsection, 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
reapportion 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) of this
section (other than subsection (i)(5) of this section) regarding data
concerning an active ingredient and fees for review of such data shall
not apply to any person who is the registrant of a pesticide to the
extent that, under section 136a(c)(2)(D) of this title, the person would
not be required to submit or cite such data to obtain an initial
registration of such pesticide.
(k) Reregistration and expedited processing fund
(1) Establishment
There shall be established in the Treasury of the United States
a reregistration and expedited processing fund which shall be known
as the Reregistration and Expedited Processing Fund.
(2) Source and use
(A) All moneys derived from fees collected by the Administrator
under subsection (i) of this section shall be deposited in the fund
and shall be available to the Administrator, without fiscal year
limitation, specifically to offset the costs of reregistration and
expedited processing of the applications specified in paragraph (3).
Such moneys derived from fees may not be expended in any fiscal year
to the extent such moneys derived from fees would exceed money
appropriated for use by the Administrator and expended in such year
for such costs of reregistration and expedited processing of such
applications. The Administrator shall, prior to expending any such
moneys derived from fees--
(i) effective October 1, 1997, adopt specific and cost
accounting rules and procedures as approved by the General
Accounting Office and the Inspector General of the Environmental
Protection Agency to ensure that moneys derived from fees are
allocated solely to the costs of reregistration and expedited
processing of the applications specified in paragraph (3) in the
same portion as appropriated funds;
(ii) prohibit the use of such moneys derived from fees to
pay for any costs other than those necessary to achieve
reregistration and expedited processing of the applications
specified in paragraph (3); and
(iii) ensure that personnel and facility costs associated
with the functions to be carried out under this paragraph do not
exceed agency averages for comparable personnel and facility
costs.
(B) The Administrator shall also--
(i) complete the review of unreviewed reregistration studies
required to support the reregistration eligibility decisions
scheduled for completion in accordance with subsection (l)(2) of
this section; and
(ii) contract for such outside assistance as may be
necessary for review of required studies, using a generally
accepted competitive process for the selection of vendors of
such assistance.
(3) Expedited processing of similar applications
(A) The Administrator shall use for each of the fiscal years
1997 through 2002, not more than \1/10\ of the maintenance fees
collected in such fiscal year 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 identified in the
application, or that would differ in composition and labeling
from any such currently-registered pesticide only in ways that
would not significantly increase the risk of unreasonable
adverse effects on the environment;
(ii) proposes an amendment to the registration of a
registered pesticide that does not require scientific review of
data; or
(iii) proposes the initial or amended registration of an end
use pesticide that, if registered as proposed, would be used for
a public health pesticide.
(B) Any amounts made available under subparagraph (A) shall be
used to obtain sufficient personnel and resources to carry out the
activities described in such subparagraph that are in addition to
the personnel and resources available to carry out such activities
on October 25, 1988.
(C) So long as the Administrator has not met the time frames
specified in clause (ii) of section 136a(c)(3)(B) of this title with
respect to any application subject to section 136a(c)(3)(B) of this
title that was received prior to August 3, 1996, the Administrator
shall use the full amount of the fees specified in subparagraph (A)
for the purposes specified therein. Once all applications subject to
section 136a(c)(3)(B) of this title that were received prior to
August 3, 1996, have been acted upon, no limitation shall be imposed
by the preceding sentence of this subparagraph so long as the
Administrator meets the time frames specified in clause (ii) of
section 136a(c)(3)(B) of this title on 90 percent of affected
applications in a fiscal year. Should the Administrator not meet
such time frames in a fiscal year, the limitations imposed by the
first sentence of this subparagraph shall apply until all overdue
applications subject to section 136a(c)(3)(B) of this title have
been acted upon.
(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
guaranteed thereby; or
(C) invested in obligations, participations, or other
instruments that are lawful investments for fiduciary, trust, or
public funds.
(5) Accounting and performance
The Administrator shall take all steps necessary to ensure that
expenditures from fees authorized by subsection (i)(5)(C)(ii) of
this section are used only to carry out the goals established under
subsection (l) of this section. The Reregistration and Expedited
Processing Fund shall be designated as an Environmental Protection
Agency component for purposes of section 3515(c) of title 31. The
annual audit required under section 3521 of such title of the
financial statements of activities under this subchapter under
section 3515(b) of such title shall include an audit of the fees
collected under subsection (i)(5)(C) of this section and disbursed,
of the amount appropriated to match such fees, and of the
Administrators attainment of performance measures and goals
established under subsection (l) of this section. Such an audit
shall also include a review of the reasonableness of the overhead
allocation and adequacy of disclosures of direct and indirect costs
associated with carrying out the reregistration and expedited
processing of the applications specified in paragraph (3), and the
basis for and accuracy of all costs paid with moneys derived from
such fees. The Inspector General shall conduct the annual audit and
report the findings and recommendations of such audit to the
Administrator and to the Committees on Agriculture of the House of
Representatives and the Senate. The cost of such audit shall be paid
for out of the fees collected under subsection (i)(5)(C) of this
section.
(l) Performance measures and goals
The Administrator shall establish and publish annually in the
Federal Register performance measures and goals. Such measures and goals
shall include--
(1) the number of products reregistered, canceled, or amended,
the status of reregistration, the number and type of data requests
under section 136a(c)(2)(B) of this title issued to support product
reregistration by active ingredient, the progress in reducing the
number of unreviewed, required reregistration studies, the aggregate
status of tolerances reassessed, and the number of applications for
registration submitted under subsection (k)(3) of this section that
were approved or disapproved;
(2) the future schedule for reregistrations, including the
projection for such schedules that will be issued under subsection
(g)(2)(A) and (B) of this section in the current fiscal year and the
succeeding fiscal year; and
(3) the projected year of completion of the reregistrations
under this section.
(m) 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 136n(b) of this title.
(n) Authorization of funds to develop public health data
(1) ``Secretary defined
For the purposes of this section, ``Secretary means the
Secretary of Health and Human Services, acting through the Public
Health Service.
(2) Consultation
In the case of a pesticide registered for use in public health
programs for vector control or for other uses the Administrator
determines to be human health protection uses, the Administrator
shall, upon timely request by the registrant or any other interested
person, or on the Administrators own initiative may, consult with
the Secretary prior to taking final action to suspend registration
under section 136a(c)(2)(B)(iv) of this title, or cancel a
registration under section 136a-1, 136d(e), or 136d(f) of this
title. In consultation with the Secretary, the Administrator shall
prescribe the form and content of requests under this section.
(3) Benefits to support family
The Administrator, after consulting with the Secretary, shall
make a determination whether the potential benefits of continued use
of the pesticide for public health or health protection purposes are
of such significance as to warrant a commitment by the Secretary to
conduct or to arrange for the conduct of the studies required by the
Administrator to support continued registration under section 136a
of this title or reregistration under this section.
(4) Additional time
If the Administrator determines that such a commitment is
warranted and in the public interest, the Administrator shall notify
the Secretary and shall, to the extent necessary, amend a notice
issued under section 136a(c)(2)(B) of this title to specify
additional reasonable time periods for submission of the data.
(5) Arrangements
The Secretary shall make such arrangements for the conduct of
required studies as the Secretary finds necessary and appropriate to
permit submission of data in accordance with the time periods
prescribed by the Administrator. Such arrangements may include
Public Health Service intramural research activities, grants,
contracts, or cooperative agreements with academic, public health,
or other organizations qualified by experience and training to
conduct such studies.
(6) Support
The Secretary may provide for support of the required studies
using funds authorized to be appropriated under this section, the
Public Health Service Act [42 U.S.C. 201 et seq.], or other
appropriate authorities. After a determination is made under
subsection (d) of this section, the Secretary shall notify the
Committees on Appropriations of the House of Representatives and the
Senate of the sums required to conduct the necessary studies.
(7) Authorization of appropriations
There is authorized to be appropriated to carry out the purposes
of this section $12,000,000 for fiscal year 1997, and such sums as
may be necessary for succeeding fiscal years.
(June 25, 1947, ch. 125, Sec. 4, formerly Sec. 3A, as added and
renumbered Sec. 4, Pub. L. 100-532, title I, Sec. 102(a), title VIII,
Sec. 801(q)(2)(A), Oct. 25, 1988, 102 Stat. 2655, 2683; amended Pub. L.
101-624, title XIV, Sec. 1493, Nov. 28, 1990, 104 Stat. 3628; Pub. L.
102-237, title X, Sec. 1006(a)(4), (e), (f), Dec. 13, 1991, 105 Stat.
1895-1897; Pub. L. 104-170, title I, Sec. 103, title II,
Secs. 210(c)(2), (f)(1), 232, 237, title V, Sec. 501, Aug. 3, 1996, 110
Stat. 1490, 1496, 1498, 1508, 1509, 1536; Pub. L. 107-73, title III,
Nov. 26, 2001, 115 Stat. 686.)
References in Text
The effective date of this section, referred to in subsecs. (a),
(c)(1), (2), and (e)(4)(A), is 60 days after Oct. 25, 1988. See
Effective Date note below.
Section 136a(c)(1)(D) of this title, referred to in subsecs.
(e)(1)(I) and (h), was redesignated section 136a(c)(1)(F) of this title
by Pub. L. 102-237, title X, Sec. 1006(a)(3)(B), Dec. 13, 1991, 105
Stat. 1894.
The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
(g)(2)(E)(ii), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
which is classified generally to chapter 9 (Sec. 301 et seq.) of Title
21, Food and Drugs. For complete classification of this Act to the Code,
see section 301 of Title 21 and Tables.
The Public Health Service Act, referred to in subsec. (n)(6), is act
July 1, 1944, ch. 373, 58 Stat. 682, as amended, which is classified
generally to chapter 6A (Sec. 201 et seq.) of Title 42, The Public
Health and Welfare. For complete classification of this Act to the Code,
see Short Title note set out under section 201 of Title 42 and Tables.
Prior Provisions
A prior section 4 of act June 25, 1947, which was classified to
section 136b of this title was transferred to section 11(a)-(c) of act
June 25, 1947, which is classified to section 136i(a)-(c) of this title.
Another prior section 4 of act June 25, 1947, was classified to
section 135b of this title prior to amendment of act June 25, 1947, by
Pub. L. 92-516.
Amendments
2001--Pub. L. 107-73, which directed the amendment of section 136a-1
of title 7, U.S.C., was executed by making the amendments to this
section, which is section 4 of the Federal Insecticide, Fungicide, and
Rodenticide Act, to reflect the probable intent of Congress. See below.
Subsec. (i)(5)(C)(i). Pub. L. 107-73 substituted ``$17,000,000 for
``$14,000,000 and ``fiscal year 2002 for ``each fiscal year.
Subsec. (i)(5)(H). Pub. L. 107-73 substituted ``2002 for ``2001.
Subsec. (i)(6). Pub. L. 107-73 substituted ``2002 for ``2001.
Subsec. (k)(3)(A). Pub. L. 107-73 substituted ``2002 for ``2001
and ``\1/10\ for ``\1/7\ in introductory provisions.
1996--Pub. L. 104-170, Sec. 501, which directed amendment of section
4 without specifying the name of the Act being amended, was executed to
this section, which is section 4 of the Federal Insecticide, Fungicide,
and Rodenticide Act, to reflect the probable intent of Congress.
Subsec. (d)(4)(B). Pub. L. 104-170, Sec. 210(c)(2), inserted at end
provisions authorizing extension of deadline for production of residue
chemistry data in case of minor use and setting forth conditions to be
met for such extension in cls. (i) to (iv).
Subsec. (d)(6). Pub. L. 104-170, Sec. 210(f)(1)(A), inserted at end
provisions delaying upon written request action with regard to
unsupported minor uses, authorizing refusal of request where there are
health or environmental concerns, authorizing publication of notice in
Federal Register and monitoring of development of data, setting forth
procedures where registrant is not meeting or has not met schedule for
production of data, and authorizing denial, modification, or revocation
of temporary extension where use may cause adverse effect on environment
and requiring notice of such revocation to registrant.
Subsec. (e)(2)(B). Pub. L. 104-170, Sec. 210(c)(2), inserted at end
provisions authorizing extension of deadline for production of residue
chemistry data in case of minor use and setting forth conditions to be
met for such extension in cls. (i) to (iv).
Subsec. (e)(3)(A). Pub. L. 104-170, Sec. 210(f)(1)(B), inserted at
end provisions delaying upon written request action with regard to
unsupported minor uses, authorizing refusal of request where there are
health or environmental concerns, authorizing publication of notice in
Federal Register and monitoring of development of data, setting forth
procedures where registrant is not meeting or has not met schedule for
production of data, and authorizing denial, modification, or revocation
of temporary extension where use may cause adverse effect on environment
and requiring notice of such revocation to registrant.
Subsec. (f)(2)(B). Pub. L. 104-170, Sec. 210(c)(2), inserted at end
provisions authorizing extension of deadline for production of residue
chemistry data in case of minor use and setting forth conditions to be
met for such extension in cls. (i) to (iv).
Subsec. (f)(3). Pub. L. 104-170, Sec. 210(f)(1)(A), inserted at end
provisions delaying upon written request action with regard to
unsupported minor uses, authorizing refusal of request where there are
health or environmental concerns, authorizing publication of notice in
Federal Register and monitoring of development of data, setting forth
procedures where registrant is not meeting or has not met schedule for
production of data, and authorizing denial, modification, or revocation
of temporary extension where use may cause adverse effect on environment
and requiring notice of such revocation to registrant.
Subsec. (g)(2)(E). Pub. L. 104-170, Sec. 103, added subpar. (E).
Subsec. (i)(4)(B) to (D). Pub. L. 104-170, Sec. 232(1), added
subpar. (B) and redesignated former subpars. (B) and (C) as (C) and (D),
respectively.
Subsec. (i)(5)(C). Pub. L. 104-170, Sec. 501(a)(2), designated
existing provisions as cl. (i) and added cl. (ii).
Subsec. (i)(5)(F), (G). Pub. L. 104-170, Sec. 232(2), added subpar.
(F) and redesignated former subpar. (F) as (G).
Subsec. (i)(5)(H). Pub. L. 104-170, Sec. 501(a)(1), substituted
``2001 for ``1997.
Pub. L. 104-170, Sec. 232(2), redesignated subpar. (G) as (H).
Subsec. (i)(6). Pub. L. 104-170, Sec. 501(a)(1), substituted
``2001 for ``1997.
Subsec. (i)(7)(B). Pub. L. 104-170, Sec. 232(3), substituted ``, to
determine the registrants eligibility for ``or to determine the
registrants eligibility and inserted before period at end ``, or to
determine the volume usage for public health pesticides.
Subsec. (k)(1). Pub. L. 104-170, Sec. 501(b), inserted ``which shall
be known as the Reregistration and Expedited Processing Fund before
period at end.
Subsec. (k)(2). Pub. L. 104-170, Sec. 501(c), amended heading and
text of par. (2) generally. Prior to amendment, text read as follows:
``All fees collected by the Administrator under subsection (i) of this
section shall be deposited into the fund and shall be available to the
Administrator, without fiscal year limitation, to carry out
reregistration and expedited processing of similar applications.
Subsec. (k)(3)(A). Pub. L. 104-170, Sec. 501(d)(1), which directed
the amendment of introductory provisions by substituting ``for each of
the fiscal years 1997 through 2001, not more than \1/7\ of the
maintenance fees collected in such fiscal year for ``for each of the
fiscal years 1992, 1993, and 1994, \1/7\th of the maintenance fees
collected, up to 2 million each year, was executed by making the
substitution for text which contained the phrase ``$2 million, to
reflect the probable intent of Congress.
Subsec. (k)(3)(A)(iii). Pub. L. 104-170, Sec. 232(4), added cl.
(iii).
Subsec. (k)(3)(C). Pub. L. 104-170, Sec. 501(d)(2), added subpar.
(C).
Subsec. (k)(5). Pub. L. 104-170, Sec. 501(e), amended heading and
text of par. (5) generally. Prior to amendment, text read as follows:
``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.
Subsec. (l). Pub. L. 104-170, Sec. 501(f), added subsec. (l). Former
subsec. (l) redesignated (m).
Subsec. (m). Pub. L. 104-170, Sec. 501(f), redesignated subsec. (l)
as (m). Former subsec. (m) redesignated (n).
Pub. L. 104-170, Sec. 237, added subsec. (m).
Subsec. (n). Pub. L. 104-170, Sec. 501(f), redesignated subsec. (m)
as (n).
1991--Subsec. (f)(3). Pub. L. 102-237, Sec. 1006(a)(4), realigned
margin.
Subsec. (i)(5). Pub. L. 102-237, Sec. 1006(e), amended par. (5)
generally, substituting, in subpar. (A), provisions relating to January
15 for provisions relating to March 1, in subpar. (A)(i), provisions
relating to fee of $650 for first registration for provisions relating
to fee of $425 for each registration for registrants holding not more
than 50 registrations, and in subpar. (A)(ii), provisions relating to
fee of $1,300 for each additional registration up to 200 registrations,
with no fee thereafter, for provisions relating to fee of $425 for each
registration up to 50, $100 for each registration over 50, with no fee
after 200 registrations, redesignating provisions formerly set out in
subpar. (A), following cl. (ii), as subpar. (B), and substituting
provisions relating to fee under this par. for provisions relating to
fee under this subpar., redesignating former subpar. (B) as (C),
striking former subpar. (C), which set maximum annual fee for
registrants under subpar. (A)(i) at $20,000, and for registrants under
subpar. (A)(ii) at $35,000, adding subpars. (D) and (E), and
redesignating former subpars. (D) and (E) as (F) and (G), respectively.
Subsec. (k)(3)(A). Pub. L. 102-237, Sec. 1006(f), substituted ``for
each of the fiscal years 1992, 1993, and 1994, \1/7\th of the
maintenance fees collected, up to $2 million each year for ``each
fiscal year not more than $2,000,000 of the amounts in the fund.
1990--Subsec. (i)(5)(A). Pub. L. 101-624 inserted sentence at end
relating to reduction or waiver of fee where pesticide is registered for
minor agricultural use.
Effective Date
Section effective on expiration of 60 days after Oct. 25, 1988, see
section 901 of Pub. L. 100-532, set out as an Effective Date of 1988
Amendment note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in sections 136a, 136d, 136j of this
title; title 21 section 346a.
Sec. 136b. Transferred.
Codification
Section, act June 25, 1947, ch. 125, Sec. 4, as added Oct. 21, 1972,
Pub. L. 92-516, Sec. 2, 86 Stat. 983; amended Nov. 28, 1975, Pub. L. 94-
140, Secs. 5, 11, 89 Stat. 753, 754; Sept. 30, 1978, Pub. L. 95-396,
Sec. 9, 92 Stat. 827; Oct. 25, 1988, Pub. L. 100-532, title VIII,
Sec. 801(c), (q)(1)(A), (B), 102 Stat. 2681, 2683, which related to use
of restricted use pesticides and certification of applicators, was
transferred to subsecs. (a) to (c) of section 11 of act June 25, 1947,
by section 801(q)(1)(A) of Pub. L. 100-532 and is classified to section
136i(a) to (c) of this title.
Sec. 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 application and all required supporting
data, the Administrator shall either issue the permit or notify the
applicant of the Administrators determination not to issue the permit
and the reasons therefor. The applicant may correct the application or
request a waiver of the conditions for such permit within thirty days of
receipt by the applicant of such notification. The Administrator may
issue an experimental use permit only if the Administrator determines
that the applicant needs such permit in order to accumulate information
necessary to register a pesticide under section 136a of this title. An
application for an experimental use permit may be filed at any time.
(b) Temporary tolerance level
If the Administrator determines that the use of a pesticide may
reasonably be expected to result in any residue on or in food or feed,
the Administrator may establish a temporary tolerance level for the
residue of the pesticide before issuing the experimental use permit.
(c) Use under permit
Use of a pesticide under an experimental 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 unreasonable adverse effects on the
environment. All results of such studies shall be reported to the
Administrator before such pesticide may be registered under section 136a
of this title.
(e) Revocation
The Administrator may revoke any experimental use permit, at any
time, if the Administrator 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 the
Administrator may by regulations prescribe, authorize any State to issue
an experimental use permit for a pesticide. All provisions of section
136i of this title relating to State plans shall apply with equal force
to a State plan for the issuance of experimental use permits under this
section.
(g) Exemption for agricultural research agencies
Notwithstanding the foregoing provisions of this section, the
Administrator may issue an experimental use permit for a pesticide to
any public or private agricultural research agency or educational
institution which applies for such permit. Each permit shall not exceed
more than a one-year period or such other specific time as the
Administrator may prescribe. Such permit shall be issued under such
terms and conditions restricting the use of the pesticide as the
Administrator may require. Such pesticide may be used only by such
research agency or educational institution for purposes of
experimentation.
(June 25, 1947, ch. 125, Sec. 5, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 983; amended Pub. L. 94-140, Sec. 10, Nov. 28, 1975,
89 Stat. 754; Pub. L. 95-396, Sec. 10, Sept. 30, 1978, 92 Stat. 828;
Pub. L. 100-532, title VIII, Sec. 801(d), (q)(1)(D), Oct. 25, 1988, 102
Stat. 2681, 2683; Pub. L. 102-237, title X, Sec. 1006(b)(1), Dec. 13,
1991, 105 Stat. 1895.)
Prior Provisions
A prior section 5 of act June 25, 1947, was classified to section
135c of this title prior to amendment of act June 25, 1947, by Pub. L.
92-516.
Amendments
1991--Subsecs. (b), (e), (f). Pub. L. 102-237 substituted ``the
Administrator for ``he before ``may in subsec. (b), before
``finds in subsec. (e), and before ``may in subsec. (f).
1988--Subsec. (f). Pub. L. 100-532, Sec. 801(q)(1)(D), substituted
``136i for ``136b.
Subsec. (g). Pub. L. 100-532, Sec. 801(d), substituted ``require.
Such pesticide for ``require: Provided, That such pesticide.
1978--Subsec. (a). Pub. L. 95-396, Sec. 10(1), provided for review
of application, issuance or nonissuance of experimental use permit
within prescribed period including reasons for denial, correction of
application, and waiver of conditions and substituted provision for
filing an application for experimental use permit at any time for prior
provision for filing at the time of or before or after an application
for registration is filed.
Subsec. (f). Pub. L. 95-396, Sec. 10(2), substituted in first
sentence ``shall for ``may where first appearing.
1975--Subsec. (g). Pub. L. 94-140 added subsec. (g).
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in sections 136, 136a, 136j of this
title.
Sec. 136d. Administrative review; suspension.
(a) Existing stocks and information
(1) Existing stocks
The Administrator may permit the continued sale and use of
existing stocks of a pesticide whose registration is suspended or
canceled under this section, or section 136a or 136a-1 of this
title, to such extent, under such conditions, and for such uses as
the Administrator determines that such sale or use is not
inconsistent with the purposes of this subchapter.
(2) Information
If at any time after the registration of a pesticide the
registrant has additional factual information regarding unreasonable
adverse effects on the environment of the pesticide, the registrant
shall submit such information to the Administrator.
(b) Cancellation and change in classification
If it appears to the Administrator that a pesticide or its labeling
or other material required to be submitted does not comply with the
provisions of this subchapter or, when used in accordance with
widespread and commonly recognized practice, generally causes
unreasonable adverse effects on the environment, the Administrator may
issue a notice of the Administrators intent either--
(1) to cancel its registration or to change its classification
together with the reasons (including the factual basis) for the
Administrators action, or
(2) to hold a hearing to determine whether or not its
registration should be canceled or its classification changed.
Such notice shall be sent to the registrant and made public. In
determining 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 Agriculture with a copy of such notice
and an analysis of such impact on the agricultural economy. If the
Secretary comments in writing to the Administrator regarding 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 and the response of the Administrator with regard to the
Secretarys 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 subsection and section 136w(d) of this title, in the
event that the Administrator determines 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
this subsection and of submission to the Scientific Advisory Panel
pursuant to section 136w(d) of this title and proceed in accordance with
subsection (c) of this section. When a public health use is affected,
the Secretary of Health and Human Services should provide available
benefits and use information, or an analysis thereof, in accordance with
the procedures followed and subject to the same conditions as the
Secretary of Agriculture in the case of agricultural pesticides. The
proposed action shall become final and effective at the end of 30 days
from receipt by the registrant, or publication, of a notice issued under
paragraph (1), whichever occurs later, unless within that time either
(i) the registrant makes the necessary corrections, if possible, or (ii)
a request for a hearing is made by a person adversely affected by the
notice. In the event a hearing is held pursuant to such a request or to
the Administrators determination under paragraph (2), a decision
pertaining to registration or classification issued after completion of
such hearing shall be final. In taking any final action under this
subsection, the Administrator shall consider restricting a pesticides
use or uses as an alternative to cancellation and shall fully explain
the reasons for these restrictions, and shall include among those
factors to be taken into account the impact of such final action on
production and prices of agricultural commodities, retail food prices,
and otherwise on the agricultural economy, and the Administrator shall
publish in the Federal Register an analysis of such impact.
(c) Suspension
(1) Order
If the Administrator determines that action is necessary to
prevent an imminent hazard during the time required for cancellation
or change in classification proceedings, the Administrator may, by
order, suspend the registration of the pesticide immediately. Except
as provided in paragraph (3), no order of suspension may be issued
under this subsection unless the Administrator has issued, or at the
same time issues, a notice of intention to cancel the registration
or change the classification of the pesticide under subsection (b)
of this section. 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, in accordance with the provisions of paragraph (2),
for an expedited hearing before the Administrator on the question of
whether an imminent hazard exists.
(2) Expedite hearing
If no request for a hearing is submitted to the Administrator
within five days of the registrants receipt of the notification
provided for by paragraph (1), the suspension order may be issued
and shall take effect and shall not be reviewable by a court. If a
hearing is requested, it shall 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 chapter 5 of title 5, except that the presiding
officer need not be a certified administrative law judge. The
presiding officer shall have ten days from the conclusion of the
presentation of evidence to submit recommended findings and
conclusions to the Administrator, who shall then have seven days to
render a final order on the issue of suspension.
(3) Emergency order
Whenever the Administrator determines that an emergency exists
that does not permit the Administrator to hold a hearing before
suspending, the Administrator may issue a suspension order in
advance of notification to the registrant. The Administrator may
issue an emergency order under this paragraph before issuing a
notice of intention to cancel the registration or change the
classification of the pesticide under subsection (b) of this section
and the Administrator shall proceed to issue the notice under
subsection (b) of this section within 90 days of issuing an
emergency order. If the Administrator does not issue a notice under
subsection (b) of this section within 90 days of issuing an
emergency order, the emergency order shall expire. In the case of an
emergency order, paragraph (2) shall apply except that (A) the order
of suspension 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
registrant and the Administrator shall participate except that any
person adversely affected may file briefs within the time allotted
by the Agencys rules. Any person so filing briefs shall be
considered a party to such proceeding for the purposes of section
136n(b) of this title.
(4) Judicial review
A final order on the question of suspension following a hearing
shall be reviewable in accordance with section 136n of this title,
notwithstanding the fact that any related cancellation proceedings
have not been completed. Any order of suspension entered prior to a
hearing before the Administrator shall be subject to immediate
review in an action by the registrant or other interested person
with the concurrence 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
effectiveness of the suspension order, pending the Administrators
final decision with respect to cancellation or change in
classification. This action may be maintained simultaneously with
any administrative review proceedings 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) of
this section or determined upon by the Administrator pursuant to
subsection (b) of this section, such hearing shall be held after due
notice for the purpose of receiving evidence relevant and material to
the issues raised by the objections filed by the applicant or other
interested parties, or to the issues stated by the Administrator, if the
hearing is called by the Administrator rather than by the filing of
objections. Upon a showing of relevance and reasonable scope of evidence
sought by any party to a public hearing, the Hearing Examiner shall
issue a subpena to compel testimony or production of documents from any
person. The Hearing Examiner shall be guided by the principles of the
Federal Rules of Civil Procedure in making any order for the protection
of the witness or the content of documents produced and shall order the
payment of reasonable fees and expenses as a condition to requiring
testimony of the witness. On contest, the 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 Examiners 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 National 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 functions of this section shall
have a financial or other conflict of interest 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 competent scientific review of the questions presented to
Committees of the Academy and to provide such other scientific advisory
services as may be required by the Administrator for carrying out the
purposes of this subchapter. As soon as practicable after completion of
the hearing (including the report of the Academy) but not later than 90
days thereafter, the Administrator shall evaluate the data and reports
before the Administrator and issue an order either revoking the
Administrators notice of intention issued pursuant to this section, or
shall issue an order either canceling the registration, changing the
classification, denying the registration, or requiring modification of
the labeling or packaging of the article. Such order shall be based only
on substantial 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 136a(c)(7) of this title if (A) the
Administrator, at any time during the period provided for satisfaction
of any condition imposed, determines that the registrant 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 subsection to such extent, under such conditions, and for such uses
as the Administrator may specify if the Administrator determines that
such sale or use is not inconsistent with the purposes of this
subchapter 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 receipt by the registrant
of the notice of intent to cancel unless during that time a request for
hearing is made by a person adversely affected by the notice. If a
hearing is requested, a hearing 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 provided or
whether the condition or conditions have been satisfied within the time
provided, and whether the Administrators determination with respect to
the disposition of existing stocks is consistent with this subchapter. 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) A registrant may, at any time, request that a pesticide
registration of the registrant be canceled or amended to terminate
one or more pesticide uses.
(B) Before acting on a request under subparagraph (A), the
Administrator shall publish in the Federal Register a notice of the
receipt of the request and provide for a 30-day period in which the
public may comment.
(C) In the case of a pesticide that is registered for a minor
agricultural use, if the Administrator determines that the
cancellation or termination of uses would adversely affect the
availability of the pesticide for use, the Administrator--
(i) shall publish in the Federal Register a notice of the
receipt of the request and make reasonable efforts to inform
persons who so use the pesticide of the request; and
(ii) may not approve or reject the request until the
termination of the 180-day period beginning on the date of
publication of the notice in the Federal Register, except that
the Administrator may waive the 180-day period upon the request
of the registrant or if the Administrator determines that the
continued use of the pesticide would pose an unreasonable
adverse effect on the environment.
(D) Subject to paragraph (3)(B), after complying with this
paragraph, the Administrator may approve or deny the request.
(2) Publication of notice
A notice of denial of registration, intent to cancel,
suspension, or intent to suspend issued under this subchapter or a
notice issued under subsection (c)(4) or (d)(5)(A) of section 136a-1
of this title shall be published in the Federal Register and shall
be sent by certified mail, return receipt requested, to the
registrants or applicants address of record on file with the
Administrator. If the mailed notice is returned to the Administrator
as undeliverable at that address, if delivery is refused, or if the
Administrator otherwise is unable to accomplish delivery 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.
(3) Transfer of registration of pesticides registered for
minor agricultural uses
In the case of a pesticide that is registered for a minor
agricultural use:
(A) During the 180-day period referred to in paragraph
(1)(C)(ii), the registrant of the pesticide may notify the
Administrator of an agreement between the registrant and a
person or persons (including persons who so use the pesticide)
to transfer the registration of the pesticide, in lieu of
canceling or amending the registration to terminate the use.
(B) An application for transfer of registration, in
conformance with any regulations the Administrator may adopt
with respect to the transfer of the pesticide registrations,
must be submitted to the Administrator within 30 days of the
date of notification provided pursuant to subparagraph (A). If
such an application is submitted, the Administrator shall
approve the transfer and shall not approve the request for
voluntary cancellation or amendment to terminate use unless the
Administrator determines that the continued use of the pesticide
would cause an unreasonable adverse effect on the environment.
(C) If the Administrator approves the transfer and the
registrant transfers the registration of the pesticide, the
Administrator shall not cancel or amend the registration to
delete the use or rescind the transfer of the registration,
during the 180-day period beginning on the date of the approval
of the transfer unless the Administrator determines that the
continued use of the pesticide would cause an unreasonable
adverse effect on the environment.
(D) The new registrant of the pesticide shall assume the
outstanding data and other requirements for the pesticide that
are pending at the time of the transfer.
(4) Utilization of data for voluntarily canceled pesticide
When an application is filed with the Administrator for the
registration of a pesticide for a minor use and another registrant
subsequently voluntarily cancels its registration for an identical
or substantially similar pesticide for an identical or substantially
similar use, the Administrator shall process, review, and evaluate
the pending application as if the voluntary cancellation had not yet
taken place except that the Administrator shall not take such action
if the Administrator determines that such minor use may cause an
unreasonable adverse effect on the environment. In order to rely on
this subsection, the applicant must certify that it agrees to
satisfy any outstanding data requirements necessary to support the
reregistration of the pesticide in accordance with the data
submission schedule established by the Administrator.
(g) Notice for stored pesticides with canceled or suspended
registrations
(1) In general
Any producer or exporter of pesticides, registrant of a
pesticide, applicant for registration of a pesticide, applicant for
or holder of an experimental use permit, commercial applicator, or
any person who distributes or sells any pesticide, who possesses any
pesticide which has had its registration canceled or suspended under
this section shall notify the Administrator 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 136n of this title.
(June 25, 1947, ch. 125, Sec. 6, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 984; amended Pub. L. 94-140, Sec. 1, Nov. 28, 1975,
89 Stat. 751; Pub. L. 95-251, Sec. 2(a)(2), Mar. 27, 1978, 92 Stat. 183;
Pub. L. 95-396, Secs. 11, 12, Sept. 30, 1978, 92 Stat. 828; Pub. L. 98-
620, title IV, Sec. 402(4)(A), Nov. 8, 1984, 98 Stat. 3357; Pub. L. 100-
532, title II, Sec. 201, title IV, Sec. 404, title VIII, Sec. 801(e),
(q)(2)(B), Oct. 25, 1988, 102 Stat. 2668, 2673, 2681, 2683; Pub. L. 101-
624, title XIV, Sec. 1494, Nov. 28, 1990, 104 Stat. 3628; Pub. L. 102-
237, title X, Sec. 1006(a)(5), (b)(1), (2), (3)(C)-(E), Dec. 13, 1991,
105 Stat. 1895, 1896; Pub. L. 104-170, title I, Secs. 102, 106(a), title
II, Secs. 210(g), (h), 233, Aug. 3, 1996, 110 Stat. 1489, 1491, 1500,
1509.)
Codification
``Subchapter II of chapter 5 of title 5, referred to in subsec.
(c)(2), was in the original ``subchapter II of Title 5, and was
editorially changed to reflect the probable intent of Congress.
Prior Provisions
A prior section 6 of act June 25, 1947, was classified to section
135d of this title prior to amendment of act June 25, 1947, by Pub. L.
92-516.
Amendments
1996--Subsec. (a). Pub. L. 104-170, Sec. 106(a)(1), substituted
``Existing stocks and information for ``Cancellation after five
years in heading.
Subsec. (a)(1). Pub. L. 104-170, Sec. 106(a)(2), amended heading and
text generally. Prior to amendment, text read as follows: ``The
Administrator shall cancel the registration of any pesticide at the end
of the five-year period which begins on the date of its registration (or
at the end of any five year period thereafter) unless the registrant, or
other interested person with the concurrence of the registrant, before
the end of such period, requests in accordance with regulations
prescribed by the Administrator that the registration be continued 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) of this section 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 subchapter and will not have unreasonable 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 registration 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.
Subsec. (b). Pub. L. 104-170, Sec. 233, inserted ``When a public
health use is affected, the Secretary of Health and Human Services
should provide available benefits and use information, or an analysis
thereof, in accordance with the procedures followed and subject to the
same conditions as the Secretary of Agriculture in the case of
agricultural pesticides. before ``The proposed action shall become
final.
Subsec. (c)(1). Pub. L. 104-170, Sec. 102(a), amended second
sentence generally. Prior to amendment, second sentence read as follows:
``No order of suspension may be issued unless the Administrator has
issued or at the same time issues notice of the Administrators
intention to cancel the registration or change the classification of the
pesticide.
Subsec. (c)(3). Pub. L. 104-170, Sec. 102(b), inserted after first
sentence ``The Administrator may issue an emergency order under this
paragraph before issuing a notice of intention to cancel the
registration or change the classification of the pesticide under
subsection (b) of this section and the Administrator shall proceed to
issue the notice under subsection (b) of this section within 90 days of
issuing an emergency order. If the Administrator does not issue a notice
under subsection (b) of this section within 90 days of issuing an
emergency order, the emergency order shall expire. and substituted
``In the case of an emergency order for ``In that case.
Subsec. (f)(1)(C)(ii). Pub. L. 104-170, Sec. 210(g)(1), substituted
``180-day for ``90-day in two places.
Subsec. (f)(3)(A). Pub. L. 104-170, Sec. 210(g)(2), substituted
``180-day for ``90-day.
Subsec. (f)(4). Pub. L. 104-170, Sec. 210(h), added par. (4).
1991--Subsec. (a)(1). Pub. L. 102-237, Sec. 1006(b)(1), substituted
``the Administrator for ``he before ``may specify and before
``determines.
Subsec. (a)(2). Pub. L. 102-237, Sec. 1006(b)(3)(C), substituted
``the registrant for ``he before ``shall.
Subsec. (b). Pub. L. 102-237, Sec. 1006(b)(1), (2), substituted
``the Administrators for ``his in introductory provisions and par.
(1), and ``the Administrator for ``he before ``shall publish in
last sentence.
Subsec. (c)(1). Pub. L. 102-237, Sec. 1006(b)(1), (2), substituted
``the Administrator for ``he before ``may and ``the
Administrators for ``his before ``intention.
Subsec. (c)(3). Pub. L. 102-237, Sec. 1006(b)(1), (3)(D),
substituted ``the Administrator for ``he before ``may and ``the
Administrator for ``him after ``permit.
Subsec. (d). Pub. L. 102-237, Sec. 1006(b)(2), (3)(E), in
penultimate sentence substituted ``the Administrators for ``his and
``the Administrator for ``him before ``and issue.
Subsec. (f)(3)(B). Pub. L. 102-237, Sec. 1006(a)(5), substituted
``adverse effect for ``adverse affect.
1990--Subsec. (f)(1). Pub. L. 101-624, Sec. 1494(1), amended par.
(1) generally. Prior to amendment, par. (1) read as follows: ``A
registrant at any time 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.
Subsec. (f)(3). Pub. L. 101-624, Sec. 1494(2), added par. (3).
1988--Subsec. (a)(1). Pub. L. 100-532, Sec. 801(e)(1), substituted
``effect. The Administrator for ``effect: Provided, That the
Administrator.
Subsec. (c). Pub. L. 100-532, Sec. 801(e)(2)-(4), in par. (1)
directed that undesignated paragraph beginning ``Except as provided be
run into sentence ending ``of the pesticide. and substituted ``before
the Administrator for ``before the Agency, in par. (2) substituted
``submitted to the Administrator for ``submitted to the Agency and
``and the Administrator for ``and the Agency, and in par. (3)
substituted ``(A) for ``(i), ``and the Administrator for ``and the
Agency, and ``(B) for ``(ii).
Subsec. (e). Pub. L. 100-532, Sec. 801(e)(5), (6), in par. (1),
substituted ``met. The Administrator for ``met: Provided, That the
Administrator, and in par. (2), substituted ``section. The only for
``section: Provided, That the only.
Subsec. (f). Pub. L. 100-532, Sec. 201, added subsec. (f). Former
subsec. (f) redesignated (h).
Subsec. (f)(2). Pub. L. 100-532, Sec. 801(q)(2)(B), made a technical
amendment to the reference to section 136a-1 of this title to reflect
the renumbering of the corresponding section of the original act.
Subsec. (g). Pub. L. 100-532, Sec. 404, added subsec. (g).
Subsec. (h). Pub. L. 100-532, Sec. 201, redesignated former subsec.
(f) as (h).
1984--Subsec. (c)(4). Pub. L. 98-620 struck out provisions requiring
petitions to review orders on the issue of suspension to be advanced on
the docket of the court of appeals.
1978--Subsec. (b). Pub. L. 95-396, Sec. 11, required the
Administrator, in taking any final action under subsec. (b), to consider
restricting a pesticides use or uses as an alternative to cancellation
and to fully explain the reasons for the restrictions.
Subsec. (c)(2). Pub. L. 95-251 substituted ``administrative law
judge for ``hearing examiner.
Subsecs. (e), (f). Pub. L. 95-396, Sec. 12, added subsec. (e) and
redesignated former subsec. (e) as (f).
1975--Subsec. (b). Pub. L. 94-140 established criteria which
Administrator must use in determining the issuance of a suspension of
registration notice and the time periods relating to such notice, set
forth required procedures to be followed by Administrator prior to
publication of such notice, required procedures when the Secretary
elects to comment or fails to comment on suspension notice, waiver or
modification of time periods in specified required procedures, required
procedures for waiver of notice and consent by Secretary for suspension
of registration, and established criteria for Secretary taking any final
action.
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Effective Date of 1984 Amendment
Amendment by Pub. L. 98-620 not applicable to cases pending on Nov.
8, 1984, see section 403 of Pub. L. 98-620, set out as an Effective Date
note under section 1657 of Title 28, Judiciary and Judicial Procedure.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in sections 136a, 136a-1, 136m, 136o,
136w of this title.
Sec. 136e. Registration of establishments.
(a) Requirement
No person shall produce any pesticide subject to this subchapter or
active ingredient used in producing a pesticide subject to this
subchapter 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 address of the
establishment and of the producer who operates such establishment.
(b) Registration
Whenever the Administrator receives an application under subsection
(a) of this section, the Administrator shall register the establishment
and assign it an establishment number.
(c) Information required
(1) Any producer operating an establishment registered under
this section shall inform the Administrator within 30 days after it
is registered of the types and amounts of pesticides and, if
applicable, active ingredients used in producing pesticides--
(A) which the producer is currently producing;
(B) which the producer has produced during the past year;
and
(C) which the producer has sold or distributed during the
past year.
The information required by this paragraph shall be kept current and
submitted to the Administrator annually as required under such
regulations as the Administrator may prescribe.
(2) Any such producer shall, upon the request of the
Administrator for the purpose of issuing a stop sale order pursuant
to section 136k of this title, inform the Administrator of the name
and address of any recipient of any pesticide produced in any
registered establishment which the producer operates.
(d) Confidential records and information
Any information submitted to the Administrator pursuant to
subsection (c) of this section other than the names of the pesticides or
active ingredients used in producing pesticides produced, sold, or
distributed at an establishment shall be considered confidential and
shall be subject to the provisions of section 136h of this title.
(June 25, 1947, ch. 125, Sec. 7, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 987; amended Pub. L. 95-396, Sec. 13, Sept. 30, 1978,
92 Stat. 829; Pub. L. 102-237, title X, Sec. 1006(b)(1), (3)(F), (G),
Dec. 13, 1991, 105 Stat. 1895, 1896.)
Prior Provisions
A prior section 7 of act June 25, 1947, was classified to section
135e of this title prior to amendment of act June 25, 1947, by Pub. L.
92-516.
Amendments
1991--Subsec. (b). Pub. L. 102-237, Sec. 1006(b)(1), substituted
``the Administrator for ``he before ``shall.
Subsec. (c)(1)(A) to (C). Pub. L. 102-237, Sec. 1006(b)(3)(F),
substituted ``the producer for ``he.
Subsec. (c)(2). Pub. L. 102-237, Sec. 1006(b)(3)(G), substituted
``the Administrator for ``him after ``inform and ``the producer
for ``he.
1978--Subsec. (a). Pub. L. 95-396, Sec. 13(1), made requirement of
registration applicable to production of active ingredient used in
producing a pesticide subject to this subchapter.
Subsec. (c)(1). Pub. L. 95-396, Sec. 13(2), required information
pertaining to types and amounts of active ingredients used in producing
pesticides where applicable.
Subsec. (d). Pub. L. 95-396, Sec. 13(3), considered names of
pesticides or active ingredients used in producing pesticides produced,
sold, or distributed at an establishment as not being confidential
information.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in sections 136, 136a, 136j, 136o, 136w
of this title.
Sec. 136f. Books and records.
(a) Requirements
The Administrator may prescribe regulations requiring producers,
registrants, and applicants for registration to maintain such records
with respect to their operations and the pesticides and devices produced
as the Administrator determines are necessary for the effective
enforcement of this subchapter and to make the records available for
inspection and copying in the same manner as provided in subsection (b)
of this section. No records required under this subsection shall extend
to financial data, sales data other than shipment data, pricing data,
personnel data, and research data (other than data relating to
registered pesticides or to a pesticide for which an application for
registration has been filed).
(b) Inspection
For the purposes of enforcing the provisions of this subchapter, 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 subchapter, shall, upon request of any officer or
employee of the Environmental Protection Agency or of any State or
political subdivision, duly designated by the Administrator, furnish or
permit such person at all reasonable times to have access to, and to
copy: (1) all records showing the delivery, movement, or holding of such
pesticide or device, including the quantity, the date of 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, pricing data, personnel data; and research data
(other than data relating to registered pesticides or to a pesticide for
which an application for registration has been filed). Before
undertaking an inspection under this subsection, the officer or employee
must present to the owner, operator, or agent in charge of the
establishment or other place where pesticides or devices are held for
distribution or sale, appropriate credentials and a written statement as
to the reason for the inspection, including a statement as to whether a
violation of the law is suspected. If no violation is suspected, an
alternate and sufficient reason shall be given in writing. Each such
inspection shall be commenced and completed with reasonable promptness.
(June 25, 1947, ch. 125, Sec. 8, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 987; amended Pub. L. 95-396, Sec. 14, Sept. 30, 1978,
92 Stat. 829; Pub. L. 100-532, title III, Sec. 301, Oct. 25, 1988, 102
Stat. 2668; Pub. L. 102-237, title X, Sec. 1006(b)(1), Dec. 13, 1991,
105 Stat. 1895.)
Prior Provisions
A prior section 8 of act June 25, 1947, was classified to section
135f of this title prior to amendment of act June 25, 1947, by Pub. L.
92-516.
Amendments
1991--Subsec. (a). Pub. L. 102-237 substituted ``the Administrator
for ``he before ``determines.
1988--Subsec. (a). Pub. L. 100-532 inserted ``, registrants, and
applicants for registration after ``requiring producers and ``and to
make the records available for inspection and copying in the same manner
as provided in subsection (b) of this section before period at end of
first sentence.
1978--Subsec. (b). Pub. L. 95-396 required, in connection with
inspection of records and information, the presentation of credentials,
written statement as to the reason for inspection, including statement
of suspected violation, or an alternative but sufficient reason, and
commencement and completion of inspection with reasonable promptness.
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in sections 136g, 136j, 136o, 136w-1 of
this title.
Sec. 136g. Inspection of establishments, etc.
(a) In general
(1) For purposes of enforcing the provisions of this subchapter,
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 pesticides or devices, packaged,
labeled, and released for shipment, and samples of any containers or
labeling for such pesticides or devices, or (B) any place where there is
being held any pesticide the registration of which has been suspended or
canceled for the purpose of determining compliance with section 136q of
this title.
(2) Before undertaking such inspection, the officers or employees
must present to the owner, operator, or agent in charge of the
establishment or other place where pesticides or devices are held for
distribution or sale, appropriate credentials and a written statement as
to the reason for the inspection, including a statement as to whether a
violation of the law is suspected. If no violation is suspected, an
alternate and sufficient reason shall be given in writing. Each such
inspection shall be commenced and completed with reasonable promptness.
If the officer or employee obtains any samples, prior to leaving the
premises, the officer or employee 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 subchapter and upon
a showing to an officer or court of competent jurisdiction that there is
reason to believe that the provisions of this subchapter have been
violated, officers or employees duly designated by the Administrator are
empowered to obtain and to execute warrants authorizing--
(1) entry, inspection, and copying of records for purposes of
this section or section 136f of this title;
(2) inspection and reproduction of all records showing the
quantity, date of shipment, and the name of consignor and consignee
of any pesticide or device found in the establishment which is
adulterated, misbranded, not registered (in the case of a pesticide)
or otherwise in violation of this subchapter and 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; and
(3) the seizure of any pesticide or device which is in violation
of this subchapter.
(c) Enforcement
(1) Certification of facts to Attorney General
The examination of pesticides or devices shall be made in the
Environmental Protection Agency or elsewhere as the Administrator
may designate for the purpose of determining from such examinations
whether they comply with the requirements of this subchapter. If it
shall appear from any such examination that they fail to comply with
the requirements of this subchapter, the Administrator 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 the persons views, either orally or in
writing, with regard to such contemplated proceedings, and if in the
opinion of the Administrator it appears that the provisions of this
subchapter 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 136l(b) of
this title or a civil proceeding under section 136l(a) of this
title, when the Administrator determines that such action will be
sufficient to effectuate the purposes of this subchapter.
(2) Notice not required
The notice of contemplated proceedings and opportunity to
present views set forth in this subsection are not prerequisites to
the institution of any proceeding by the Attorney General.
(3) Warning notices
Nothing in this subchapter shall be construed as requiring the
Administrator to institute proceedings for prosecution of minor
violations of this subchapter whenever the Administrator believes
that the public interest will be adequately served by a suitable
written notice of warning.
(June 25, 1947, ch. 125, Sec. 9, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 988; amended Pub. L. 100-532, title III, Sec. 302,
Oct. 25, 1988, 102 Stat. 2669; Pub. L. 102-237, title X,
Sec. 1006(b)(1), (3)(H), (I), Dec. 13, 1991, 105 Stat. 1895, 1896.)
Prior Provisions
A prior section 9 of act June 25, 1947, was classified to section
135g of this title prior to amendment of act June 25, 1947, by Pub. L.
92-516.
Amendments
1991--Subsec. (a)(2). Pub. L. 102-237, Sec. 1006(b)(3)(H),
substituted ``the officer or employee for ``he before ``shall in
fourth sentence.
Subsec. (c)(1). Pub. L. 102-237, Sec. 1006(b)(3)(I), substituted
``the persons for ``his in third sentence.
Subsec. (c)(3). Pub. L. 102-237, Sec. 1006(b)(1), substituted ``the
Administrator for ``he before ``believes.
1988--Subsec. (a). Pub. L. 100-532, Sec. 302(a), substituted ``(1)
For purposes of for ``For purposes of, inserted ``of the
Environmental Protection Agency or of any State, substituted ``at
reasonable times (A) for ``at reasonable times,, added cl. (B), and
substituted ``(2) Before for ``Before.
Subsec. (b)(1). Pub. L. 100-532, Sec. 302(b), amended par. (1)
generally, substituting ``entry, inspection, and copying of records for
purposes of this section or section 136f of this title for ``entry for
the purpose of this section.
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in section 136w-1 of this title.
Sec. 136h. Protection of trade secrets and other information.
(a) In general
In submitting data required by this subchapter, the applicant may
(1) clearly mark any portions thereof which in the applicants opinion
are trade secrets or commercial or financial information and (2) submit
such market material separately from other material required to be
submitted under this subchapter.
(b) Disclosure
Notwithstanding any other provision of this subchapter and subject
to the limitations in subsections (d) and (e) of this section, the
Administrator shall not make public information which in the
Administrators judgment contains or relates to trade secrets or
commercial or financial information obtained from a person and
privileged or confidential, except that, when necessary to carry out the
provisions of this subchapter, information relating to formulas of
products acquired by authorization of this subchapter 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 inspection information
which the applicant or registrant believes to be protected from
disclosure under subsection (b) of this section, the Administrator shall
notify the applicant or registrant, in writing, by certified mail. The
Administrator shall not thereafter make available for inspection such
data until thirty days after receipt of the notice by the applicant or
registrant. During this period, the applicant or registrant may
institute an action in an appropriate district court for a declaratory
judgment as to whether such information is subject to protection under
subsection (b) of this section.
(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 wildlife, humans and other mammals, plants,
animals, and soil, and studies on persistence, translocation and fate in
the environment, and metabolism, shall be available for disclosure to
the public. The use of such data for any registration purpose shall be
governed by section 136a of this title. 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, detecting,
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 confidential
treatment under subsection (b) of this section may be publicly disclosed
in connection with a public proceeding to determine whether a pesticide,
or any ingredient of a pesticide, causes unreasonable adverse effects on
health or the environment, if the Administrator determines that such
disclosure is necessary in the public interest.
(3) If the Administrator proposes to disclose information described
in clause (A), (B), or (C) of paragraph (1) or in paragraph (2) of this
subsection, the Administrator shall notify by certified mail the
submitter of such information of the intent to release such information.
The Administrator may not release such information, without the
submitters 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 (C) of paragraph (1) of
this subsection is necessary to avoid or lessen an imminent and
substantial risk of injury to the public health, the Administrator may
set such shorter period of notice (but not less than ten days) and such
method of notice as the Administrator finds appropriate. During such
period the data submitter may institute an action in an appropriate
district court to enjoin or limit the proposed disclosure. The court may
enjoin disclosure, or limit the disclosure or the parties to whom
disclosure shall be made, to the extent that--
(A) in the case of information described in clause (A), (B), or
(C) of paragraph (1) of this subsection, the proposed disclosure is
not 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 information.
(e) Disclosure to contractors
Information otherwise protected from disclosure to the public under
subsection (b) of this section may be disclosed to contractors with the
United States and employees of such contractors if, in the opinion of
the Administrator, such disclosure is necessary for the satisfactory
performance by the contractor of a contract with the United States for
the performance of work in connection with this subchapter and under
such conditions as the Administrator may specify. The Administrator
shall require as a condition to the disclosure of information under this
subsection that the person receiving it take such security precautions
respecting the information as the Administrator shall by regulation
prescribe.
(f) Penalty for disclosure by Federal employees
(1) Any officer or employee of the United States or former officer
or employee of the United States who, by virtue of such employment or
official position, has obtained possession of, or has access to,
material the disclosure of which is prohibited by subsection (b) of this
section, and who, knowing that disclosure of such material is prohibited
by such subsection, willfully discloses the material in any manner to
any person not entitled to receive it, shall be fined not more than
$10,000 or imprisoned for not more than one year, or both. Section 1905
of title 18 shall not apply with respect to the publishing, divulging,
disclosure, or making known of, or making available, information
reported or otherwise obtained under this subchapter. Nothing in this
subchapter shall preempt any civil remedy under State or Federal law for
wrongful disclosure of trade secrets.
(2) For the purposes of this section, any contractor with the United
States who is furnished information as authorized by subsection (e) of
this section, or any employee of any such contractor, shall be
considered to be an employee of the United States.
(g) Disclosure to foreign and multinational pesticide producers
(1) The Administrator shall not knowingly disclose information
submitted by an applicant or registrant under this subchapter to any
employee or agent of any business or other entity engaged in the
production, sale, or distribution of pesticides in countries other than
the United States or in addition to the United States or to any other
person who intends to deliver such data to such foreign or multinational
business or entity unless the applicant or registrant has consented to
such disclosure. The Administrator shall require an affirmation from any
person who intends to inspect data that such person does not seek access
to the data for 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 negligently cause the data to be delivered to
such business or entity or its agents or employees. Notwithstanding any
other provision of this subsection, the Administrator may disclose
information to any person in connection with a public proceeding under
law or regulation, subject to restrictions on the availability of
information contained elsewhere in this subchapter, which information is
relevant to a determination by the Administrator with respect to whether
a pesticide, or any ingredient of a pesticide, causes unreasonable
adverse effects on health or the environment.
(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 applicant or
registrant of the names and affiliations of such persons.
(3) Section 1001 of title 18 shall apply to any affirmation made
under paragraph (1) of this subsection.
(June 25, 1947, ch. 125, Sec. 10, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 989; amended Pub. L. 95-396, Sec. 15, Sept. 30, 1978,
92 Stat. 829; Pub. L. 98-620, title IV, Sec. 402(4)(B), Nov. 8, 1984, 98
Stat. 3357; Pub. L. 100-532, title VIII, Sec. 801(f), Oct. 25, 1988, 102
Stat. 2682; Pub. L. 102-237, title X, Sec. 1006(b)(1), (2), (3)(J), Dec.
13, 1991, 105 Stat. 1895, 1896.)
Prior Provisions
A prior section 10 of act June 25, 1947, was classified to section
135h of this title prior to amendment of act June 25, 1947, by Pub. L.
92-516.
Amendments
1991--Subsec. (a). Pub. L. 102-237, Sec. 1006(b)(3)(J), substituted
``the applicants for ``his.
Subsec. (b). Pub. L. 102-237, Sec. 1006(b)(2), substituted ``the
Administrators for ``his.
Subsec. (c). Pub. L. 102-237, Sec. 1006(b)(1), substituted ``the
Administrator for ``he before ``shall notify.
1988--Subsec. (d). Pub. L. 100-532 in par. (1), substituted
``public. The use for ``public: Provided, That the use and ``title.
This paragraph for ``title: Provided further, That this paragraph,
and in par. (3), ``notice. Where for ``notice: Provided, That where.
1984--Subsec. (d)(3). Pub. L. 98-620 struck out provisions requiring
the court to give expedited consideration to actions involving
injunctions or limitations of proposed disclosure.
1978--Subsec. (b). Pub. L. 95-396, Sec. 15(1), made disclosure of
information by the Administrator subject to the limitations of subsecs.
(d) and (e) of this section.
Subsecs. (d) to (g). Pub. L. 95-396, Sec. 15(2), added subsecs. (d)
to (g).
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Effective Date of 1984 Amendment
Amendment by Pub. L. 98-620 not applicable to cases pending on Nov.
8, 1984, see section 403 of Pub. L. 98-620, set out as an Effective Date
note under section 1657 of Title 28, Judiciary and Judicial Procedure.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in sections 136a, 136e of this title;
title 21 section 346a.
Sec. 136i. Use of restricted use pesticides; applicators.
Sec. 136i. Use of restricted use pesticides; applicators
(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 certification of applicators of pesticides. Such
program shall conform to the requirements imposed upon the States
under the provisions of subsection (a)(2) of this section and shall
not require private applicators to take any examination to establish
competency 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 Administrator 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 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 require any person engaging in the commercial application, sale,
offering for sale, holding for sale, or distribution of any
pesticide one or more uses of which have been classified for
restricted use to maintain such records and submit such reports
concerning the commercial application, sale, or distribution of such
pesticide as the Administrator may by regulation prescribe. Subject
to paragraph (2), the Administrator shall prescribe standards for
the certification of applicators of pesticides. Such standards shall
provide that to be certified, an individual must be determined to be
competent with respect to the use and handling of the pesticides, or
to the use and handling of the pesticide or class of pesticides
covered by such individuals certification. The certification
standard for a private applicator shall, under a State plan
submitted for approval, be deemed fulfilled by the applicator
completing a certification form. The Administrator shall further
assure that such form contains adequate information and affirmations
to carry out the intent of this subchapter, and may include in the
form an affirmation that the private applicator has completed a
training program approved by the Administrator so long as the
program does not require the private applicator to take, pursuant to
a requirement prescribed 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
program to be licensed under a State licensing program approved by
the Administrator.
(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 modification thereof, if such plan in the
Administrators 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 reports to
the Administrator in such form and containing such information
as the Administrator may from time to time require; and
(E) contains satisfactory assurances that State standards
for the certification of applicators of pesticides conform with
those 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.
(b) State plans
If the Administrator rejects a plan submitted under subsection
(a)(2) of this section, the Administrator shall afford the State
submitting the plan due notice and opportunity for hearing before so
doing. If the Administrator approves a plan submitted under subsection
(a)(2) of this section, 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, the
Administrator shall so notify the State and provide for a hearing at the
request of the State, and, if appropriate 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 techniques
Standards prescribed by the Administrator for the certification of
applicators of pesticides under subsection (a) of this section, and
State plans submitted to the Administrator under subsection (a) of this
section, shall include provisions for making instructional materials
concerning integrated pest management techniques available to
individuals at their request in accordance with the provisions of
section 136u(c) of this title, but such plans may not require that any
individual receive instruction concerning such techniques or to be shown
to be competent with respect to the use of such techniques. The
Administrator and States implementing such plans shall provide that all
interested individuals are notified on the availability of such
instructional materials.
(d) In general
No regulations prescribed by the Administrator for carrying out the
provisions of this subchapter shall require any private applicator to
maintain any records or file any reports or other documents.
(e) Separate standards
When establishing or approving standards for licensing or
certification, the Administrator shall establish separate standards for
commercial and private applicators.
(June 25, 1947, ch. 125, Sec. 11, formerly Secs. 4, 11, as added Pub. L.
92-516, Sec. 2, Oct. 21, 1972, 86 Stat. 983, 989; amended Pub. L. 94-
140, Secs. 5, 11, Nov. 28, 1975, 89 Stat. 753, 754; Pub. L. 95-396,
Sec. 9, Sept. 30, 1978, 92 Stat. 827; Pub. L. 100-532, title VIII,
Sec. 801(c), (q)(1)(A)-(C), Oct. 25, 1988, 102 Stat. 2681, 2683; Pub. L.
102-237, title X, Sec. 1006(a)(6), (b)(1), (2), (3)(K), Dec. 13, 1991,
105 Stat. 1895, 1896.)
Codification
Pub. L. 100-532, Sec. 801(q)(1)(A), transferred subsecs. (a) to (c)
of section 4 of act June 25, 1947, which was classified to section 136b
of this title, to subsecs. (a) to (c) of this section.
Prior Provisions
A prior section 11 of act June 25, 1947, was classified to section
135i of this title prior to amendment of act June 25, 1947, by Pub. L.
92-516.
Amendments
1991--Pub. L. 102-237, Sec. 1006(a)(6)(A), substituted
``applicators for ``appplicators in section catchline.
Subsec. (a)(1). Pub. L. 102-237, Sec. 1006(b)(3)(K), substituted
``the applicator for ``his in ninth sentence and ``the
Administrator for ``him before period at end.
Subsec. (a)(2). Pub. L. 102-237, Sec. 1006(b)(2), substituted ``the
Administrators for ``his in introductory provisions.
Subsec. (b). Pub. L. 102-237, Sec. 1006(a)(6)(B), (b)(1),
substituted ``subsection (a)(2) of this section for ``this paragraph
in two places and ``the Administrator for ``he before ``shall
afford and before ``shall so notify.
Subsec. (c). Pub. L. 102-237, Sec. 1006(a)(6)(C), substituted
``subsection (a) for ``subsections (a) and (b) after ``Administrator
under.
1988--Pub. L. 100-532, Sec. 801(q)(1)(A), (C), substituted section
catchline for one which read: ``Standards applicable to pesticide
applicators, redesignated subsecs. (a) and (b) as (d) and (e),
respectively, and transferred subsecs. (a) to (c) of section 136b of
this title to subsecs. (a) to (c), respectively, of this section.
Subsec. (a)(1). Pub. L. 100-532, Sec. 801(c), substituted
``pesticides. Such program for ``pesticides: Provided, That such
program and ``certification. The certification for ``certification:
Provided, however, That the certification.
1978--Subsec. (a)(1). Pub. L. 95-396 required that, in any State
without a State plan for applicator certification approved by the
Administrator, the Administrator, in consultation with the Governor of
the State, shall conduct a program for the certification of applicators
of pesticides under a Federal plan for applicator certification, and
also that in such a State records be maintained and reports submitted by
persons engaged in commercial application, sale or distribution of
pesticides classified for restricted use.
1975--Subsec. (a)(1). Pub. L. 94-140, Sec. 5, inserted proviso
relating to Administrators powers and duties with respect to the
certification forms and requirement for pesticide dealers participating
in certification program.
Subsec. (c). Pub. L. 94-140, Sec. 11, added subsec. (c).
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in sections 136, 136c, 136j, 136q, 136w-
1 of this title.
Sec. 136i-1. Pesticide recordkeeping.
(a) Requirements
(1) The Secretary of Agriculture, in consultation with the
Administrator of the Environmental Protection Agency, shall require
certified applicators of restricted use pesticides (of the type
described under section 136a(d)(1)(C) of this title) to maintain records
comparable to records maintained by commercial applicators of pesticides
in each State. If there is no State requirement for the maintenance of
records, such applicator shall maintain records that contain the product
name, amount, approximate date of application, and location of
application of each such pesticide used for a 2-year period after such
use.
(2) Within 30 days of a pesticide application, a commercial
certified applicator shall provide a copy of records maintained under
paragraph (1) to the person for whom such application was provided.
(b) Access
Records maintained under subsection (a) of this section shall be
made available to any Federal or State agency that deals with pesticide
use or any health or environmental issue related to the use of
pesticides, on the request of such agency. Each such Federal agency
shall conduct surveys and record the data from individual applicators to
facilitate statistical analysis for environmental and agronomic
purposes, but in no case may a government agency release data, including
the location from which the data was derived, that would directly or
indirectly reveal the identity of individual producers. In the case of
Federal agencies, such access to records maintained under subsection (a)
of this section shall be through the Secretary of Agriculture, or the
Secretarys designee. State agency requests for access to records
maintained under subsection (a) of this section shall be through the
lead State agency so designated by the State.
(c) Health care personnel
When a health professional determines that pesticide information
maintained under this section is necessary to provide medical treatment
or first aid to an individual who may have been exposed to pesticides
for which the information is maintained, upon request persons required
to maintain records under subsection (a) of this section shall promptly
provide record and available label information to that health
professional. In the case of an emergency, such record information shall
be provided immediately.
(d) Penalty
The Secretary of Agriculture shall be responsible for the
enforcement of subsections (a), (b), and (c) of this section. A
violation of such subsection shall--
(1) in the case of the first offense, be subject to a fine of
not more than $500; and
(2) in the case of subsequent offenses, be subject to a fine of
not less than $1,000 for each violation, except that the penalty
shall be less than $1,000 if the Secretary determines that the
person made a good faith effort to comply with such subsection.
(e) Federal or State provisions
The requirements of this section shall not affect provisions of
other Federal or State laws.
(f) Surveys and reports
The Secretary of Agriculture and the Administrator of the
Environmental Protection Agency, shall survey the records maintained
under subsection (a) of this section to develop and maintain a data base
that is sufficient to enable the Secretary and the Administrator to
publish annual comprehensive reports concerning agricultural and
nonagricultural pesticide use. The Secretary and Administrator shall
enter into a memorandum of understanding to define their respective
responsibilities under this subsection in order to avoid duplication of
effort. Such reports shall be transmitted to Congress not later than
April 1 of each year.
(g) Regulations
The Secretary of Agriculture and the Administrator of the
Environmental Protection Agency shall promulgate regulations on their
respective areas of responsibility implementing this section within 180
days after November 28, 1990.
(Pub. L. 101-624, title XIV, Sec. 1491, Nov. 28, 1990, 104 Stat. 3627;
Pub. L. 102-237, title X, Sec. 1006(d), Dec. 13, 1991, 105 Stat. 1896.)
Codification
Section was enacted as part of the Conservation Program Improvements
Act, and also as part of the Food, Agriculture, Conservation, and Trade
Act of 1990, and not as part of the Federal Insecticide, Fungicide, and
Rodenticide Act which comprises this subchapter.
Amendments
1991--Subsec. (a)(1). Pub. L. 102-237, Sec. 1006(d)(1), inserted
closing parenthesis after ``section 136a(d)(1)(C) of this title.
Subsec. (d)(1). Pub. L. 102-237, Sec. 1006(d)(2), inserted ``of
after ``fine.
Sec. 136i-2. Collection of pesticide use information.
(a) In general
The Secretary of Agriculture shall collect data of statewide or
regional significance on the use of pesticides to control pests and
diseases of major crops and crops of dietary significance, including
fruits and vegetables.
(b) Collection
The data shall be collected by surveys of farmers or from other
sources offering statistically reliable data.
(c) Coordination
The Secretary of Agriculture shall, as appropriate, coordinate with
the Administrator of the Environmental Protection Agency in the design
of the surveys and make available to the Administrator the aggregate
results of the surveys to assist the Administrator.
(Pub. L. 104-170, title III, Sec. 302, Aug. 3, 1996, 110 Stat. 1512.)
Codification
Section was enacted as part of the Food Quality Protection Act of
1996, and not as part of the Federal Insecticide, Fungicide, and
Rodenticide Act which comprises this subchapter.
Pesticide Use Information Study
Section 305 of Pub. L. 104-170 provided that:
``(a) The Secretary of Agriculture shall, in consultation with the
Administrator of the Environmental Protection Agency, prepare a report
to Congress evaluating the current status and potential improvements in
Federal pesticide use information gathering activities. This report
shall at least include--
``(1) an analysis of the quality and reliability of the
information collected by the Department of Agriculture, the
Environmental Protection Agency, and other Federal agencies
regarding the agricultural use of pesticides; and
``(2) an analysis of options to increase the effectiveness of
national pesticide use information collection, including an analysis
of costs, burdens placed on agricultural producers and other
pesticide users, and effectiveness in tracking risk reduction by
those options.
``(b) The Secretary shall submit this report to Congress not later
than 1 year following the date of enactment of this section [Aug. 3,
1996].
Sec. 136j. Unlawful acts.
(a) In general
(1) Except as provided by subsection (b) of this section, it shall
be unlawful for any person in any State to distribute or sell to any
person--
(A) any pesticide that is not registered under section 136a of
this title 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 subchapter;
(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 136a of this title;
(C) any registered pesticide the composition of which differs at
the time of its distribution or sale from its composition as
described in the statement required in connection with its
registration under section 136a of this title;
(D) any pesticide which has not been colored or discolored
pursuant to the provisions of section 136w(c)(5) of this title;
(E) any pesticide which is adulterated or misbranded; or
(F) any device which is misbranded.
(2) It shall be unlawful for any person--
(A) to detach, alter, deface, or destroy, in whole or in part,
any labeling required under this subchapter;
(B) to refuse to--
(i) prepare, maintain, or submit any records required by or
under section 136c, 136e, 136f, 136i, or 136q of this title;
(ii) submit any reports required by or under section 136c,
136d, 136e, 136f, 136i, or 136q of this title; or
(iii) allow any entry, inspection, copying of records, or
sampling authorized by this subchapter;
(C) to give a guaranty or undertaking provided for in subsection
(b) of this section which is false in any particular, except that a
person who receives and relies upon a guaranty authorized under
subsection (b) of this section may give a guaranty to the same
effect, which guaranty shall contain, in addition to the persons
own name and address, the name and address of the person residing in
the United States from whom the person received the guaranty or
undertaking;
(D) to use for the persons own advantage or to reveal, other
than to the Administrator, or officials or employees of the
Environmental 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 information acquired by authority of this subchapter
which is confidential under this subchapter;
(E) who is a registrant, wholesaler, dealer, retailer, or other
distributor to advertise a product registered under this subchapter
for restricted use without giving the classification of the product
assigned to it under section 136a of this title;
(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 section 136a(d) of
this title and any regulations thereunder, except that it shall not
be unlawful to sell, under regulations issued by the Administrator,
a restricted use pesticide to a person who is not a certified
applicator for application by a certified applicator;
(G) to use any registered pesticide in a manner inconsistent
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 136k of this
title;
(J) to violate any suspension order issued under section
136a(c)(2)(B), 136a-1, or 136d of this title;
(K) to violate any cancellation order issued under this
subchapter or to fail to submit a notice in accordance with section
136d(g) of this title;
(L) who is a producer to violate any of the provisions of
section 136e of this title;
(M) to knowingly falsify all or part of any application for
registration, application for experimental use permit, any
information submitted to the Administrator pursuant to section 136e
of this title, any records required to be maintained pursuant to
this subchapter, any report filed under this subchapter, or any
information marked as confidential and submitted to the
Administrator under any provision of this subchapter;
(N) who is a registrant, wholesaler, dealer, retailer, or other
distributor to fail to file reports required by this subchapter;
(O) to add any substance to, or take any substance from, any
pesticide in a manner that may defeat the purpose of this
subchapter;
(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;
(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 equipment 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
subchapter;
(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 136a(a) or
136q of this title.
(b) Exemptions
The penalties provided for a violation of paragraph (1) of
subsection (a) of this section 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 the person purchased or
received in good faith the pesticide in the same unbroken package,
to the effect that the pesticide was lawfully registered at the time
of sale and delivery to the person, and that it complies with the
other requirements of this subchapter, and in such case the
guarantor shall be subject to the penalties which would otherwise
attach to the person holding the guaranty under the provisions of
this subchapter;
(2) any carrier while lawfully shipping, transporting, or
delivering for shipment any pesticide or device, if such carrier
upon request of any officer or employee duly designated by the
Administrator shall permit such officer or employee to copy all of
its records concerning such pesticide or device;
(3) any public official while engaged in the performance of the
official duties of the public official;
(4) any person using or possessing any pesticide as provided by
an experimental use permit in effect with respect to such pesticide
and such use or possession; or
(5) any person who ships a substance or mixture of substances
being put through tests in which the purpose is only to determine
its value for pesticide purposes or to determine its toxicity or
other properties and from which the user does not expect to receive
any benefit in pest control from its use.
(June 25, 1947, ch. 125, Sec. 12, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 989; amended Pub. L. 95-396, Sec. 16, Sept. 30, 1978,
92 Stat. 832; Pub. L. 100-532, title VI, Secs. 601(b)(2), 603, title
VIII, Sec. 801(g), (q)(2)(B), Oct. 25, 1988, 102 Stat. 2677, 2678, 2682,
2683; Pub. L. 102-237, title X, Sec. 1006(a)(7), (b)(3)(L)-(O), Dec. 13,
1991, 105 Stat. 1895, 1896.)
Prior Provisions
A prior section 12 of act June 25, 1947, was classified to section
135j of this title prior to amendment of act June 25, 1947, by Pub. L.
92-516.
Amendments
1991--Subsec. (a)(2)(C). Pub. L. 102-237, Sec. 1006(b)(3)(L),
substituted ``the persons for ``his and ``the person for ``he
before ``received.
Subsec. (a)(2)(D). Pub. L. 102-237, Sec. 1006(b)(3)(M), substituted
``the persons for ``his.
Subsec. (a)(2)(F). Pub. L. 102-237, Sec. 1006(a)(7)(A), substituted
``thereunder, except that it for ``thereunder. It.
Subsec. (a)(2)(O). Pub. L. 102-237, Sec. 1006(a)(7)(B), struck out
``or after semicolon at end.
Subsec. (a)(2)(P). Pub. L. 102-237, Sec. 1006(a)(7)(C), substituted
a semicolon for period at end.
Subsec. (b)(1). Pub. L. 102-237, Sec. 1006(b)(3)(N), substituted
``the person for ``he after ``from whom and for ``him after
``delivery to.
Subsec. (b)(3). Pub. L. 102-237, Sec. 1006(b)(3)(O), substituted
``the official duties of the public official for ``his official
duties.
1988--Subsec. (a)(1). Pub. L. 100-532, Sec. 601(b)(2)(A), in
introductory provisions, substituted ``distribute or sell to any
person for ``distribute, sell, offer for sale, hold for sale, ship,
deliver for shipment, or receive and (having so received) deliver or
offer to deliver, to any person.
Subsec. (a)(1)(A). Pub. L. 100-532, Sec. 603(1), added subpar. (A)
and struck out former subpar. (A) which read as follows: ``any pesticide
which is not registered under section 136a of this title, except as
provided by section 136d(a)(1) of this title;.
Subsec. (a)(2)(B). Pub. L. 100-532, Sec. 603(2)(A), added subpar.
(B) and struck out former subpar. (B) which read as follows: ``to refuse
to keep any records required pursuant to section 136f of this title, or
to refuse to allow inspection of any records or establishment pursuant
to section 136f or 136g of this title, or to refuse to allow an officer
or employee of the Environmental Protection Agency to take a sample of
any pesticide pursuant to section 136g of this title;.
Subsec. (a)(2)(F). Pub. L. 100-532, Secs. 601(b)(2)(B), 801(g),
substituted ``to distribute or sell, or to make for ``to make and
``thereunder, It for ``thereunder: Provided, That it.
Subsec. (a)(2)(J). Pub. L. 100-532, Sec. 801(q)(2)(B), made a
technical amendment to the reference to section 136a-1 of this title to
reflect the renumbering of the corresponding section of the original
act.
Pub. L. 100-532, Sec. 603(2)(B), added subpar. (J) and struck out
former subpar. (J) which read as follows: ``to violate any suspension
order issued under section 136d of this title;.
Subsec. (a)(2)(K). Pub. L. 100-532, Sec. 603(2)(B), added subpar.
(K) and struck out former subpar. (K) which read as follows: ``to
violate any cancellation of registration of a pesticide under section
136d of this title, except as provided by section 136d(a)(1) of this
title;.
Subsec. (a)(2)(M). Pub. L. 100-532, Sec. 603(2)(C), substituted
``this subchapter for ``section 136f of this title.
Subsec. (a)(2)(Q), (R), (S). Pub. L. 100-532, Sec. 603(2)(D), added
subpars. (Q), (R), and (S).
1978--Subsec. (a)(2)(F). Pub. L. 95-396 inserted proviso exempting
from prohibition the sale, under regulations issued by the
Administrator, of a restricted use pesticide to a person who is not a
certified applicator for application by a certified applicator.
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Sec. 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 subchapter, 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 suspended, the Administrator may issue a
written or printed ``stop sale, use, or removal order to any person
who owns, controls, or has custody of such pesticide or device, and
after receipt of such order no person shall sell, use, or remove the
pesticide or device described in the order except in accordance with the
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
section 136a of this title;
(C) its labeling fails to bear the information required by
this subchapter;
(D) it is not colored or discolored and such coloring or
discoloring is required under this subchapter; or
(E) any of the claims made for it or any of the directions
for its use differ in substance from the representations made in
connection with its registration;
(2) in the case of a device, it is misbranded; or
(3) in the case of a pesticide or device, when used in
accordance with the requirements imposed under this subchapter and
as directed by the labeling, it nevertheless causes unreasonable
adverse effects on the environment.
In the case of a plant regulator, defoliant, or desiccant, used in
accordance with the label claims and recommendations, physical or
physiological effects on plants or parts thereof shall not be deemed to
be injury, when such effects are the purpose for which the plant
regulator, defoliant, or desiccant was applied.
(c) Disposition after condemnation
If the pesticide or device is 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 not be
sold contrary to the provisions of this subchapter or the laws of the
jurisdiction in which it is sold. On payment of the costs of the
condemnation proceedings and the execution and delivery of a good and
sufficient bond conditioned that the pesticide or device shall not be
sold or otherwise disposed of contrary to the provisions of the
subchapter 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
proceedings shall be at the suit of and in the name of the United
States.
(d) Court costs, etc.
When a decree of condemnation is entered against the pesticide or
device, court costs and fees, storage, and other proper expenses shall
be awarded against the person, if any, intervening as claimant of the
pesticide or device.
(June 25, 1947, ch. 125, Sec. 13, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 991; amended Pub. L. 100-532, title VIII,
Sec. 801(h), Oct. 25, 1988, 102 Stat. 2682.)
Prior Provisions
A prior section 13 of act June 25, 1947, was classified to section
135k of this title prior to amendment of act June 25, 1947, by Pub. L.
92-516.
Amendments
1988--Subsec. (b). Pub. L. 100-532, Sec. 801(h)(1), directed that
sentence beginning ``In the case of be moved from par. (3) and become
a full measure sentence after par. (3).
Subsec. (c). Pub. L. 100-532, Sec. 801(h)(2), substituted ``sold.
On for ``sold: Provided, That upon.
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in sections 136e, 136j, 136q of this
title.
Sec. 136l. Penalties.
(a) Civil penalties
(1) In general
Any registrant, commercial applicator, wholesaler, dealer,
retailer, or other distributor who violates any provision of this
subchapter may be assessed a civil penalty by the Administrator of
not more than $5,000 for each offense.
(2) Private applicator
Any private applicator or other person not included in paragraph
(1) who violates any provision of this subchapter subsequent to
receiving a written warning from the Administrator or following a
citation for a prior violation, may be assessed a civil penalty by
the Administrator of not more than $1,000 for each offense, except
that any applicator not included under paragraph (1) of this
subsection who holds or applies registered pesticides, or uses
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 subchapter
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
subsequent 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 incorporated city of the residence
of the person charged.
(4) Determination of penalty
In determining the amount of the penalty, the Administrator
shall consider the appropriateness of such penalty to the size of
the business of the person charged, the effect on the persons
ability to continue in business, and the gravity of the violation.
Whenever the Administrator finds that the violation occurred despite
the exercise of due care or did not cause significant harm to health
or the environment, the Administrator may issue a warning in lieu of
assessing a penalty.
(5) References to Attorney General
In case of inability to collect such civil penalty or failure of
any person to pay all, or such portion of such civil penalty as the
Administrator may determine, the Administrator shall refer the
matter to the Attorney General, who shall recover such amount by
action in the appropriate United States district court.
(b) Criminal penalties
(1) In general
(A) Any registrant, applicant for a registration, or producer
who knowingly violates any provision of this subchapter 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 pesticide, or
any other person not described in subparagraph (A) who distributes
or sells pesticides or devices, who knowingly violates any provision
of this subchapter 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 subchapter shall be
guilty of a misdemeanor and shall on conviction be fined not more
than $1,000, or imprisoned for not more than 30 days, or both.
(3) Disclosure of information
Any person, who, with intent to defraud, uses or reveals
information relative to formulas of products acquired under the
authority of section 136a of this title, shall be fined not more
than $10,000, or imprisoned for not more than three years, or both.
(4) Acts of officers, agents, etc.
When construing and enforcing the provisions of this subchapter,
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.
(June 25, 1947, ch. 125, Sec. 14, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 992; amended Pub. L. 95-396, Sec. 17, Sept. 30, 1978,
92 Stat. 832; Pub. L. 100-532, title VI, Sec. 604, Oct. 25, 1988, 102
Stat. 2678; Pub. L. 102-237, title X, Sec. 1006(a)(8), Dec. 13, 1991,
105 Stat. 1895.)
Amendments
1991--Subsec. (a)(2). Pub. L. 102-237 substituted ``, except that
for ``: Provided, That and ``uses for ``use.
1988--Subsec. (b)(1). Pub. L. 100-532 amended par. (1) generally.
Prior to amendment, par. (1) read as follows: ``Any registrant,
commercial applicator, wholesaler, dealer, retailer, or other
distributor who knowingly violates any provision of this subchapter
shall be guilty of a misdemeanor and shall on conviction be fined not
more than $25,000, or imprisoned for not more than one year, or both.
1978--Subsec. (a)(2). Pub. L. 95-396, Sec. 17(1), authorized
assessment of a civil penalty of not more than $500 for a first offense
and not more than $1,000 for each subsequent offense against any
applicator providing a service of controlling pests for violations of
this subchapter.
Subsec. (a)(3). Pub. L. 95-396, Sec. 17(2), struck out provision
respecting certain considerations when determining amount of penalty,
now covered in par. (4).
Subsec. (a)(4). Pub. L. 95-396, Sec. 17(4), reenacted second
sentence of par. (3) as par. (4) and authorized Administrator to issue a
warning in lieu of assessing a penalty. Former par. (4) redesignated
(5).
Subsec. (a)(5). Pub. L. 95-396, Sec. 17(3), redesignated former par.
(4) as (5).
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in sections 136a-1, 136g, 136q of this
title.
Sec. 136m. Indemnities.
(a) General indemnification
(1) In general
Except as otherwise provided in this section, if--
(A) the Administrator notifies a registrant under section
136d(c)(1) of this title that the Administrator intends to
suspend a registration or that an emergency order of suspension
of a registration under section 136d(c)(3) of this title has
been issued;
(B) the registration in question is suspended under section
136d(c) of this title, and thereafter is canceled under section
136d(b), 136d(d), or 136d(f) of this title; and
(C) any person who owned any quantity of the pesticide
immediately before the notice to the registrant under
subparagraph (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 Administrator finds that
the person--
(A) had knowledge of facts that, in themselves, would have
shown that the pesticide did not meet the requirements of
section 136a(c)(5) of this title for registration; and
(B) continued thereafter to produce the pesticide without
giving timely notice of such facts to the Administrator.
(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 Agriculture of the House of
Representatives, the Committee on Agriculture, Nutrition, and
Forestry of the Senate, and the Committees 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
payment.
(4) Appropriation
The Administrator may not make a payment 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 distributors
(1) End users
If--
(A) the Administrator notifies a registrant under section
136d(c)(1) of this title that the Administrator intends to
suspend a registration or that an emergency order of suspension
of a registration under section 136d(c)(3) of this title has
been issued;
(B) the registration in question is suspended under section
136d(c) of this title, and thereafter is canceled under section
136d(b), 136d(d), or 136d(f) of this title; 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 pesticide as an
end user, rather than for purposes of distributing or selling it
or further processing it for distribution or sale, suffered a
loss by reason of the suspension or cancellation 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 distributor
(hereinafter in this paragraph referred to as a ``seller) of a
registered pesticide who distributes or sells the pesticide 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, reimburse such person for the cost of
first acquiring the pesticide 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
pesticide is not subject to reimbursement by the seller.
(B) If--
(i) the Administrator notifies a registrant under section
136d(c)(1) of this title that the Administrator intends to
suspend a registration or that an emergency order of suspension
of a registration under section 136d(c)(3) of this title has
been issued;
(ii) the registration in question is suspended under section
136d(c) of this title, and thereafter is canceled under section
136d(b), 136d(d), or 136d(f) of this title;
(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 pesticide; and
(II) owned any quantity of the pesticide for purposes
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 cancellation 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 subparagraph
(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
sellers 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 paragraph (1) or (2) shall
be made from the appropriation provided under section 1304 of title
31.
(4) Administrative settlement
An administrative settlement of a claim for such indemnity may
be made in accordance with the third paragraph of section 2414 of
title 28 and shall be regarded as if it were made under that section
for purposes of section 1304 of title 31.
(c) Amount of payment
(1) In general
The amount of an indemnity payment under subsection (a) or (b)
of this section to any person shall be determined on the basis of
the cost of the pesticide owned by the person (other than the cost
of transportation, if any) immediately before the issuance of the
notice to the registrant referred to in subsection (a)(1)(A),
(b)(1)(A), or (b)(2)(B)(i) of this section, except that in no event
shall an indemnity payment to any person exceed the fair market
value of the pesticide owned by the person immediately before the
issuance of the notice.
(2) Special rule
Notwithstanding any other provision of this subchapter, the
Administrator may provide a reasonable time for use or other
disposal of the pesticide. In determining the quantity 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.
(June 25, 1947, ch. 125, Sec. 15, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 993; amended Pub. L. 100-532, title V, Sec. 501(a),
Oct. 25, 1988, 102 Stat. 2674.)
Amendments
1988--Pub. L. 100-532 amended section generally, in subsec. (a),
substituting provisions relating to general indemnification for
provisions relating to requirements for payment, adding subsec. (b), and
redesignating provisions of former subsec. (b), with further amendment,
as subsec. (c).
Effective Date of 1988 Amendment
Section 501(a) of Pub. L. 100-532 provided that amendment made by
Pub. L. 100-532 is effective 180 days after Oct. 25, 1988.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Interim Payments
Section 501(b) of Pub. L. 100-532 provided that:
``(1) Source.--Any obligation of the Administrator to pay an
indemnity arising under section 15 [this section], as it existed prior
to the effective date of the amendment made by this section [see
Effective Date of 1988 Amendment note above], shall be made from the
appropriation provided under section 1304 of title 31, United States
Code.
``(2) Administrative settlement.--An administrative settlement of a
claim for such indemnity may be made in accordance 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.
Section Referred to in Other Sections
This section is referred to in section 136a of this title.
Sec. 136n. Administrative procedure; judicial review.
(a) District court review
Except as otherwise provided in this subchapter, 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 controversy as to the validity of any order
issued by the Administrator following a public hearing, any person who
will be adversely affected by such order and who had been a party to the
proceedings may obtain judicial review by filing in the United States
court of appeals for the circuit wherein such person resides or has a
place of business, within 60 days after the entry of such order, a
petition 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 the Administrator for
that purpose, and thereupon the Administrator shall file in the court
the record of the proceedings on which the Administrator based the
Administrators order, as provided in section 2112 of title 28. 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
Administrator shall be sustained if it is supported by substantial
evidence when considered on the record as a whole. The judgment of the
court affirming or setting aside, in whole or in part, any order under
this section shall be final, subject to review by the Supreme Court of
the United States upon certiorari or certification as provided in
section 1254 of title 28. The commencement of proceedings under this
section shall not, unless specifically ordered by the court to the
contrary, operate as a stay of an order.
(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 subchapter.
(d) Notice of judgments
The Administrator shall, by publication in such manner as the
Administrator may prescribe, give notice of all judgments entered in
actions instituted under the authority of this subchapter.
(June 25, 1947, ch. 125, Sec. 16, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 994; amended Pub. L. 98-620, title IV,
Sec. 402(4)(C), Nov. 8, 1984, 98 Stat. 3357; Pub. L. 100-532, title
VIII, Sec. 801(i), Oct. 25, 1988, 102 Stat. 2682; Pub. L. 102-237, title
X, Sec. 1006(b)(1), (2), (3)(P), Dec. 13, 1991, 105 Stat. 1895, 1896.)
Amendments
1991--Subsec. (b). Pub. L. 102-237, Sec. 1006(b)(1), (2), (3)(P),
substituted ``the Administrator for ``he before ``based, ``the
Administrators for ``his, and ``the Administrator for ``him
after ``designated by.
Subsec. (d). Pub. L. 102-237, Sec. 1006(b)(1), substituted ``the
Administrator for ``he before ``may.
1988--Subsec. (a). Pub. L. 100-532 amended subsec. (a) generally.
Prior to amendment, subsec. (a) read as follows: ``Except as is
otherwise provided in this subchapter, Agency refusals to cancel or
suspend registrations or change classifications not following a hearing
and other final Agency actions not committed to Agency discretion by law
are judicially reviewable in the district courts.
1984--Subsec. (b). Pub. L. 98-620 struck out provisions requiring
the court to advance on the docket and expedite the disposition of all
cases filed pursuant to this section.
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Effective Date of 1984 Amendment
Amendment by Pub. L. 98-620 not applicable to cases pending on Nov.
8, 1984, see section 403 of Pub. L. 98-620, set out as an Effective Date
note under section 1657 of Title 28, Judiciary and Judicial Procedure.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in sections 136a, 136a-1, 136d, 136q of
this title.
Sec. 136o. Imports and exports.
(a) Pesticides and devices intended for export
Notwithstanding any other provision of this subchapter, no pesticide
or device or active ingredient used in producing a pesticide intended
solely for export to any foreign country shall be deemed in violation of
this subchapter--
(1) when prepared or packed according to the specifications or
directions of the foreign purchaser, except that producers of such
pesticides and devices and active ingredients used in producing
pesticides shall be subject to sections 136(p), (q)(1)(A), (C), (D),
(E), (G), and (H), 136(q)(2)(A), (B), (C)(i) and (iii), and (D),
136e, and 136f of this title; and
(2) in the case of any pesticide other than a pesticide
registered under section 136a or sold under section 136d(a)(1) of
this title, if, prior to export, the foreign purchaser has signed a
statement acknowledging that the purchaser understands that such
pesticide is not registered for use in the United States and cannot
be sold in the United States under this subchapter.
A copy of that statement shall be transmitted to an appropriate official
of the government of the importing country.
(b) Cancellation notices furnished to foreign governments
Whenever a registration, or a cancellation or suspension of the
registration of a pesticide becomes effective, or ceases to be
effective, the Administrator shall transmit through the State Department
notification thereof to the governments of other 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
concerning other pesticides that are registered under section 136a of
this title and that could be used in lieu of such pesticide.
(c) Importation of pesticides and devices
The Secretary of the Treasury shall notify the Administrator of the
arrival of pesticides and devices and shall deliver to the
Administrator, upon the Administrators request, samples of pesticides
or devices which are being imported into the United States, giving
notice to the owner or consignee, who may appear before the
Administrator and have the right to introduce testimony. If it appears
from the examination of a sample that it is adulterated, or misbranded
or otherwise violated the provisions set forth in this subchapter, 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 consignee and shall cause the destruction of any
pesticide or device refused delivery which shall not be exported by the
consignee within 90 days from the date of notice of such refusal under
such regulations as the Secretary of the Treasury may prescribe. The
Secretary of the Treasury may deliver to the consignee such pesticide or
device pending examination and decision in the matter on execution of
bond for the amount of the full invoice value of such pesticide or
device, together with the duty thereon, and on refusal to return such
pesticide or device for any cause to the custody of the Secretary of the
Treasury, when demanded, for the purpose of excluding them from the
country, or for any other purpose, said consignee shall forfeit the full
amount of said bond. All charges for storage, cartage, and labor on
pesticides or devices which are refused admission or delivery shall be
paid by the owner or consignee, and in default of such payment shall
constitute a lien against any future importation made by such owner or
consignee.
(d) Cooperation in international efforts
The Administrator shall, in cooperation with the Department of State
and any other appropriate Federal agency, participate and cooperate in
any international efforts to develop improved pesticide research and
regulations.
(e) Regulations
The Secretary of the Treasury, in consultation with the
Administrator, shall prescribe regulations for the enforcement of
subsection (c) of this section.
(June 25, 1947, ch. 125, Sec. 17, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 995; amended Pub. L. 95-396, Sec. 18(a), Sept. 30,
1978, 92 Stat. 833; Pub. L. 100-532, title VIII, Sec. 801(j), Oct. 25,
1988, 102 Stat. 2682; Pub. L. 102-237, title X, Sec. 1006(a)(9), (b)(2),
Dec. 13, 1991, 105 Stat. 1895.)
Amendments
1991--Subsec. (a). Pub. L. 102-237, Sec. 1006(a)(9), removed last
sentence from par. (2) and placed it as a full measure sentence under
par. (2).
Subsec. (c). Pub. L. 102-237, Sec. 1006(b)(2), substituted ``the
Administrators for ``his.
1988--Subsec. (c). Pub. L. 100-532 substituted ``prescribe. The
Secretary for ``prescribe: Provided, That the Secretary and ``bond.
All for ``bond: And provided further, That all.
1978--Subsec. (a). Pub. L. 95-396, Sec. 18(a)(1), amended subsec.
(a) generally.
Subsec. (b). Pub. L. 95-396, Sec. 18(a)(2), inserted sentence at end
relating to information to be included in notification.
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Effective Date of 1978 Amendment
Section 18(b) of Pub. L. 95-396 provided that: ``The amendment made
by subsection (a)(1) of this section [amending this section] shall
become effective one hundred and eighty days after the date of enactment
of this Act [Sept. 30, 1978].
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in section 136a of this title.
Sec. 136p. Exemption of Federal and State agencies.
The Administrator may, at the Administrators discretion, exempt any
Federal or State agency from any provision of this subchapter if the
Administrator determines that emergency conditions exist which require
such exemption. The Administrator, in determining whether or not such
emergency conditions exist, shall consult with the Secretary of
Agriculture and the Governor of any State concerned if they request such
determination.
(June 25, 1947, ch. 125, Sec. 18, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 995; amended Pub. L. 94-140, Sec. 8, Nov. 28, 1975,
89 Stat. 754; Pub. L. 100-532, title VIII, Sec. 801(k), Oct. 25, 1988,
102 Stat. 2682; Pub. L. 102-237, title X, Sec. 1006(b)(1), (2), Dec. 13,
1991, 105 Stat. 1895.)
Amendments
1991--Pub. L. 102-237 substituted ``the Administrator for ``he
before ``determines and ``the Administrators for ``his.
1988--Pub. L. 100-532 substituted ``and for ``or`` in section
catchline, and directed that sentence beginning ``The Administrator,
in be run in after first sentence beginning ``The Administrator may.
1975--Pub. L. 94-140 inserted provision requiring Administrator to
consult with Secretary of Agriculture and Governor of State concerned in
determining whether an emergency situation exists.
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in sections 136, 136a of this title;
title 21 section 346a.
Sec. 136q. Storage, disposal, transportation, and recall.
(a) Storage, disposal, and transportation
(1) Data requirements and registration of pesticides
The Administrator may require under section 136a or 136d of this
title that--
(A) the registrant or applicant for registration of a
pesticide 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 registration
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 contain
or collect excess or spilled quantities of the pesticide; and
(C) the registrant of a pesticide provide evidence of
sufficient financial and other resources to carry out a recall
plan under subsection (b) of this section, and provide for the
disposition of the pesticide, in the event of suspension and
cancellation of the pesticide.
(2) Pesticides
The Administrator may by regulation, or as part of an order
issued under section 136d of this title 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 registration 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 registration 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 Administrator may by regulation, or as part of an order
issued under section 136d of this title or an amendment to such an
order--
(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 quantities 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 136d of this title, and if the Administrator
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 paragraph (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 informal
hearing, that the plan is inadequate to protect health or the
environment.
(3) Mandatory recall
If, after determining under paragraph (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 subsection may require any person
that is subject to the regulation to--
(A) arrange to make available one or more storage facilities
to receive and store the pesticide to which the recall program
applies, and inform the Administrator of the location of each
such facility;
(B) accept and store at such a facility those existing
stocks of such pesticide that are tendered by any other 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, provide
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 pesticide
of the terms of the recall regulation and how those persons may
tender the pesticide and arrange for transportation 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 procedure imposed in accordance with paragraph
(2) of subsection (a) of this section 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) of this section for a pesticide whose registration
has been suspended and canceled shall, as soon as practicable after
the suspension of the registration of the pesticide, 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 registrant, the Administrator shall
reimburse the registrant, on request, 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 Administrator 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 approval
of the plan by the Administrator or the date of cancellation 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 approval of
the plan by the Administrator or the date of cancellation 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 year
following the date of the approval of the plan by the
Administrator or the date of cancellation of the registration 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 substance regarding the ultimate allocation of
the costs of storage, transportation, or disposal of a pesticide.
(2) Rule and regulation review
Section 136w(a)(4) of this title shall not apply to any
regulation issued under subsection (a)(2) or (b) of this section.
(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 subsection (a)(2) or (b) of this section
has failed substantially to comply with that regulation or order,
the Administrator may take action under section 136k or 136l of this
title or obtain injunctive relief under section 136n(c) of this
title 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, 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 compliance with the regulations
referred to in paragraph (1) not later than 5 years after the
effective date of this subsection.
(f) Pesticide residue removal
(1) Procedures
(A) Not later than 3 years after the effective date of this
subsection, 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 containers prior to disposal.
(B) The regulations may--
(i) specify, for each major type of pesticide container,
procedures and standards providing for, at a minimum, triple
rinsing or the equivalent degree of pesticide removal;
(ii) specify procedures that can be implemented promptly and
easily in various circumstances and conditions;
(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
Administrator, exempt products intended solely for household use
from the requirements of this subsection.
(2) Compliance
Effective beginning 5 years after the effective date of this
subsection, a State may not exercise primary enforcement
responsibility under section 136w-1 of this title, or certify an
applicator under section 136i of this title, unless the
Administrator 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 pesticide 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 containers;
(ii) the development and use of pesticide formulations 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 environmental
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, the Administrator shall submit to Congress a report
describing the results of the study required under paragraph (1).
(h) Relationship to Solid Waste Disposal Act
(1) In general
Nothing in this section shall diminish the authorities or
requirements of the Solid Waste Disposal Act (42 U.S.C. 6901 et
seq.).
(2) Antimicrobial products
A household, industrial, or institutional antimicrobial product
that is not subject to regulation under the Solid Waste Disposal Act
(42 U.S.C. 6901 et seq.) shall not be subject to the provisions of
subsections (a), (e), and (f) of this section, unless the
Administrator determines that such product must be subject to such
provisions to prevent an unreasonable adverse effect on the
environment.
(June 25, 1947, ch. 125, Sec. 19, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 995; amended Pub. L. 95-396, Sec. 19, Sept. 30, 1978,
92 Stat. 833; Pub. L. 100-532, title IV, Secs. 401-403, title VIII,
Sec. 801(q)(1)(D), Oct. 25, 1988, 102 Stat. 2669, 2672, 2683; Pub. L.
104-170, title II, Sec. 225, Aug. 3, 1996, 110 Stat. 1507.)
References in Text
The effective date of this subsection, referred to in subsecs. (e),
(f)(1)(A), (2), and (g)(2), is 60 days after Oct. 25, 1988, the
effective date of Pub. L. 100-532. See Effective Date of 1988 Amendment
note below.
The Solid Waste Disposal Act, referred to in subsecs. (f)(1)(B)(iv),
(3) and (h), is title II of Pub. L. 89-272, Oct. 20, 1965, 79 Stat. 997,
as amended generally by Pub. L. 94-580, Sec. 2, Oct. 21, 1976, 90 Stat.
2795, which is classified generally to chapter 82 (Sec. 6901 et seq.) of
Title 42, The Public Health and Welfare. For complete classification of
this Act to the Code, see Short Title note set out under section 6901 of
Title 42 and Tables.
Amendments
1996--Subsec. (h). Pub. L. 104-170 designated existing provisions as
par. (1), inserted heading, and added par. (2).
1988--Pub. L. 100-532, Sec. 401, amended section generally, in
subsec. (a) substituting provisions which related to storage, disposal,
and transportation, for provisions which directed Secretary to establish
procedures for disposal or storage, in subsec. (b) substituting
provisions which related to recalls, for provisions which directed
Administrator to provide advice to Secretary of Transportation, in
subsec. (c) substituting provisions which related to storage costs, for
provisions which related to disposal of unused quantities, and adding
subsec. (d).
Subsec. (a)(3). Pub. L. 100-532, Sec. 402, added par. (3).
Subsecs. (e), (f). Pub. L. 100-532, Sec. 403, added subsecs. (e) and
(f).
Subsec. (f)(2). Pub. L. 100-532, Sec. 801(q)(1)(D), substituted
``136i for ``136b.
Subsecs. (g), (h). Pub. L. 100-532, Sec. 403, added subsecs. (g) and
(h).
1978--Subsec. (c). Pub. L. 95-396 added subsec. (c).
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in sections 136g, 136j of this title.
Sec. 136r. Research and monitoring.
(a) Research
The Administrator shall undertake research including research by
grant or contract with other Federal agencies, universities, or others
as may be necessary to carry out the purposes of this subchapter, and
the Administrator shall conduct research into integrated pest management
in coordination with the Secretary of Agriculture. The Administrator
shall also take care to ensure that such research does not duplicate
research being undertaken by any other Federal agency.
(b) National monitoring plan
The Administrator shall formulate and periodically revise, in
cooperation with other Federal, State, or local agencies, a national
plan for monitoring pesticides.
(c) Monitoring
The Administrator shall undertake such monitoring activities,
including, but not limited to monitoring in air, soil, water, man,
plants, and animals, as may be necessary for the implementation of this
subchapter and of the national pesticide monitoring plan. The
Administrator shall establish procedures for the monitoring of man and
animals and their environment for incidential \1\ pesticide exposure,
including, but not limited to, the quantification 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.
---------------------------------------------------------------------------
\1\ So in original. Probably should be ``incidental.
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(June 25, 1947, ch. 125, Sec. 20, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 996; amended Pub. L. 95-396, Sec. 20, Sept. 30, 1978,
92 Stat. 834; Pub. L. 102-237, title X, Sec. 1006(a)(10), (b)(1), Dec.
13, 1991, 105 Stat. 1895.)
Amendments
1991--Subsec. (a). Pub. L. 102-237 substituted ``ensure for
``insure and ``the Administrator for ``he before ``shall
conduct.
1978--Subsec. (a). Pub. L. 95-396, Sec. 20(1), substituted in first
sentence ``shall conduct research into integrated pest management in
coordination with the Secretary of Agriculture for ``shall give
priority to research to develop biologically integrated alternatives for
pest control.
Subsec. (c). Pub. L. 95-396, Sec. 20(2), inserted provision
requiring establishment of monitoring procedures and the carrying out of
the activities in cooperation with other Federal, State, and local
agencies.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Availability of Grants
Pub. L. 106-74, title III, Oct. 20, 1999, 113 Stat. 1081, provided
in part: ``That notwithstanding 7 U.S.C. 136r and 15 U.S.C. 2609,
beginning in fiscal year 2000 and thereafter, grants awarded under
section 20 of the Federal Insecticide, Fungicide, and Rodenticide Act [7
U.S.C. 136r], as amended, and section 10 of the Toxic Substances Control
Act [15 U.S.C. 2609], as amended, shall be available for research,
development, monitoring, public education, training, demonstrations, and
studies.
Section Referred to in Other Sections
This section is referred to in section 5881 of this title.
Sec. 136r-1. Integrated Pest Management.
The Secretary of Agriculture, in cooperation with the Administrator,
shall implement research, demonstration, and education programs to
support adoption of Integrated Pest Management. Integrated Pest
Management is a sustainable approach to managing pests by combining
biological, cultural, physical, and chemical tools in a way that
minimizes economic, health, and environmental risks. The Secretary of
Agriculture and the Administrator shall make information on Integrated
Pest Management widely available to pesticide users, including Federal
agencies. Federal agencies shall use Integrated Pest Management
techniques in carrying out pest management activities and shall promote
Integrated Pest Management through procurement and regulatory policies,
and other activities.
(Pub. L. 104-170, title III, Sec. 303, Aug. 3, 1996, 110 Stat. 1512.)
Codification
Section was enacted as part of the Food Quality Protection Act of
1996, and not as part of the Federal Insecticide, Fungicide, and
Rodenticide Act which comprises this subchapter.
Sec. 136s. Solicitation of comments; notice of public hearings.
(a) Secretary of Agriculture
The Administrator, before publishing regulations under this
subchapter, shall solicit the views of the Secretary of Agriculture in
accordance with the procedure described in section 136w(a) of this
title.
(b) Secretary of Health and Human Services
The Administrator, before publishing regulations under this
subchapter for any public health pesticide, shall solicit the views of
the Secretary of Health and Human Services in the same manner as the
views of the Secretary of Agriculture are solicited under section
136w(a)(2) of this title.
(c) Views
In addition to any other authority relating to public hearings and
solicitation of views, in connection with the suspension or cancellation
of a pesticide registration or any other actions authorized under this
subchapter, the Administrator may, at the Administrators discretion,
solicit the views of all interested persons, either orally or in
writing, and seek such advice from scientists, farmers, farm
organizations, and other qualified persons as the Administrator deems
proper.
(d) Notice
In connection with all public hearings under this subchapter the
Administrator shall publish timely notice of such hearings in the
Federal Register.
(June 25, 1947, ch. 125, Sec. 21, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 996; amended Pub. L. 94-140, Sec. 2(b), Nov. 28,
1975, 89 Stat. 752; Pub. L. 100-532, title VIII, Sec. 801(l), Oct. 25,
1988, 102 Stat. 2682; Pub. L. 102-237, title X, Sec. 1006(b)(1), (2),
Dec. 13, 1991, 105 Stat. 1895; Pub. L. 104-170, title II, Sec. 234, Aug.
3, 1996, 110 Stat. 1509.)
Amendments
1996--Subsecs. (b) to (d). Pub. L. 104-170 added subsec. (b) and
redesignated former subsecs. (b) and (c) as (c) and (d), respectively.
1991--Subsec. (b). Pub. L. 102-237 substituted ``the Administrator
for ``he before ``deems and ``the Administrators for ``his.
1988--Pub. L. 100-532, Sec. 801(l), inserted headings for subsecs.
(a) to (c).
1975--Subsec. (a). Pub. L. 94-140 inserted ``in accordance with the
procedure described in section 136w(a) of this title after ``Secretary
of Agriculture.
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Sec. 136t. Delegation and cooperation.
(a) Delegation
All authority vested in the Administrator by virtue of the
provisions of this subchapter 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 Department of Agriculture,
any other Federal agency, and any appropriate agency of any State or any
political subdivision thereof, in carrying out the provisions of this
subchapter, and in securing uniformity of regulations.
(June 25, 1947, ch. 125, Sec. 22, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 996.)
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Sec. 136u. 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 subchapter through the use of
its personnel or facilities, to train personnel of the State or
Indian tribe to cooperate in the enforcement of this subchapter, and
to assist States and Indian tribes in implementing cooperative
enforcement programs through grants-in-aid; and
(2) to assist States in developing and administering State
programs, and Indian tribes that enter into cooperative agreements,
to train and certify applicators consistent with the standards the
Administrator prescribes.
Effective with the fiscal year beginning October 1, 1978, there are
authorized to be appropriated annually such funds as may be necessary
for the Administrator to provide through cooperative agreements an
amount equal to 50 percent of the anticipated cost to each State or
Indian tribe, as agreed to under such cooperative agreements, of
conducting training and certification 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 agencies for the purpose of encouraging
the training of certified applicators.
(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 pesticide users about accepted uses and
other regulations made under this subchapter.
(June 25, 1947, ch. 125, Sec. 23, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 996; amended Pub. L. 95-396, Sec. 21, Sept. 30, 1978,
92 Stat. 834.)
Amendments
1978--Subsec. (a). Pub. L. 95-396 extended provisions to Indian
tribes, authorized annual appropriation of funds for training and
certification programs, and required proportionate reduction of shares
in the allocation of available funds when appropriations do not cover 50
percent of the annual costs.
Subsec. (b). Pub. L. 95-396 authorized contracts with Indian tribal
agencies.
Subsec. (c). Pub. L. 95-396 substituted ``shall for ``may,
substituted ``use for ``utilize, and ``to inform and educate
pesticide users about accepted uses and other regulations for ``for
informing farmers of accepted uses and other regulations.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Availability of Grants for Pesticide Program Development and
Implementation
Pub. L. 105-276, title III, Oct. 21, 1998, 112 Stat. 2499, provided
in part: ``That beginning in fiscal year 1999 and thereafter, pesticide
program implementation grants under section 23(a)(1) of the Federal
Insecticide, Fungicide and Rodenticide Act, as amended [7 U.S.C.
136u(a)(1)], shall be available for pesticide program development and
implementation, including enforcement and compliance activities.
Section Referred to in Other Sections
This section is referred to in sections 136i, 136w-1 of this title.
Sec. 136v. 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 prohibited by this
subchapter.
(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 subchapter.
(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 subchapter and if registration for such use has not
previously been denied, disapproved, or canceled by the Administrator.
Such registration shall be deemed registration under section 136a of
this title for all purposes of this subchapter, but shall authorize
distribution and use only within such State.
(2) A registration issued by a State under this subsection shall not
be effective for more than ninety days if disapproved by the
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 intention to
disapprove and the reasons therefor, and provide the State time to
respond. The Administrator shall not prohibit or disapprove a
registration issued by a State under this subsection (A) on the basis of
lack of essentiality of a pesticide or (B) 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 [21 U.S.C. 301 et seq.] that permits the
residues of the pesticides 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 disapprove the registration.
(4) If the Administrator finds, in accordance with standards set
forth in regulations issued under section 136w of this title, 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 subchapter or has failed to exercise adequate controls,
the Administrator may suspend the authority of the State to register
pesticides until such time as the Administrator is satisfied that the
State can and will exercise adequate controls. Prior to any such
suspension, the Administrator shall advise the State of the
Administrators intention to suspend and the reasons therefor and
provide the State time to respond.
(June 25, 1947, ch. 125, Sec. 24, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 997; amended Pub. L. 95-396, Sec. 22, Sept. 30, 1978,
92 Stat. 835; Pub. L. 100-532, title VIII, Sec. 801(m), Oct. 25, 1988,
102 Stat. 2682.)
References in Text
The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
(c)(3), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which
is classified generally to chapter 9 (Sec. 301 et seq.) of Title 21,
Food and Drugs. For complete classification of this Act to the Code, see
section 301 of Title 21 and Tables.
Amendments
1988--Pub. L. 100-532, Sec. 801(m), inserted headings for subsecs.
(a) to (c) and realigned margins of pars. (1) to (4) of subsec. (c).
1978--Subsec. (a). Pub. L. 95-396 inserted ``federally registered
before ``pesticide or device.
Subsec. (b). Pub. L. 95-396 substituted ``labeling or packaging
and ``required under for ``labeling and packaging and ``required
pursuant to, respectively.
Subsec. (c)(1). Pub. L. 95-396 incorporated existing text in
provisions designated par. (1) and substituted ``registration for
additional uses of federally registered pesticides for ``registration
for pesticides.
Subsec. (c)(2). Pub. L. 95-396 incorporated existing text in
provisions designated par. (2), conditioned disapproval of registration
on communication of intention to disapprove and reasons for disapproval
and provision for time to respond, and restricted authority of
Administrator to prohibit or disapprove a State registration.
Subsec. (c)(3). Pub. L. 95-396 added par. (3).
Subsec. (c)(4). Pub. L. 95-396 incorporated existing text in
provisions designated par. (4) and authorized suspension of registration
authority of the State based on findings of inability or failure to
exercise adequate controls following an indication of intention to
suspend and reasons for the suspension and provision for time to
respond.
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in sections 136, 136a of this title.
Sec. 136w. Authority of Administrator.
Sec. 136w-1. State primary enforcement responsibility.
(a) In general
For the purposes of this subchapter, 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 subchapter;
(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 agreement with the
Administrator under section 136u of this title for the enforcement of
pesticide use restrictions shall have the primary enforcement
responsibility for pesticide use violations. Any State that has a plan
approved by the Administrator in accordance with the requirements of
section 136i of this title that the Administrator determines 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 136i of this title in effect on September 30, 1978, not
later than six months after that date.
(c) Administrator
The Administrator shall have primary enforcement responsibility for
those States that do not have primary enforcement responsibility under
this subchapter. Notwithstanding the provisions of section 136(e)(1) of
this title, during any period when the Administrator has such
enforcement responsibility, section 136f(b) of this title shall apply to
the books and records of commercial applicators and to any applicator
who holds or applies pesticides, or uses dilutions of pesticides, only
to provide a service of controlling pests without delivering any
unapplied pesticide to any person so served, and section 136g(a) of this
title shall apply to the establishment or other place where pesticides
or devices are held for application by such persons with respect to
pesticides or devices held for such application.
(June 25, 1947, ch. 125, Sec. 26, as added Pub. L. 95-396, Sec. 24(2),
Sept. 30, 1978, 92 Stat. 836; amended Pub. L. 100-532, title VIII,
Sec. 801(o), (q)(1)(D), Oct. 25, 1988, 102 Stat. 2683; Pub. L. 102-237,
title X, Sec. 1006(a)(11), Dec. 13, 1991, 105 Stat. 1895.)
Prior Provisions
A prior section 26 of act June 25, 1947, ch. 125, was renumbered
section 33 and is classified to section 136x of this title.
Amendments
1991--Subsec. (c). Pub. L. 102-237 substituted ``uses for ``use.
1988--Subsec. (a). Pub. L. 100-532, Sec. 801(o)(1), (2), inserted
heading and substituted ``regulations. The Administrator for
``regulations; Provided, That the Administrator in par. (1).
Subsec. (b). Pub. L. 100-532, Sec. 801(o)(3), (q)(1)(D), inserted
heading and substituted ``136i for ``136b in two places.
Subsec. (c). Pub. L. 100-532, Sec. 801(o)(4), inserted heading.
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in sections 136q, 136w-2 of this title.
Sec. 136w-2. Failure by the State to assure enforcement of State pesticide use regulations.
(a) Referral
Upon receipt of any complaint or other information alleging or
indicating a significant violation of the pesticide use provisions of
this subchapter, the Administrator shall refer the matter to the
appropriate State officials for their investigation of the matter
consistent with the requirements of this subchapter. If, within thirty
days, the State has not commenced appropriate enforcement action, the
Administrator may act upon the complaint or information to the extent
authorized under this subchapter.
(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 inadequate. The State shall have
ninety days after receipt of the notice to correct any deficiencies. If
after that time the Administrator determines that the State program
remains inadequate, the Administrator may rescind, in whole or in part,
the States primary enforcement responsibility for pesticide use
violations.
(c) Construction
Neither section 136w-1 of this title nor this section shall limit
the authority of the Administrator to enforce this subchapter, where the
Administrator determines that emergency conditions exist that require
immediate action on the part of the Administrator and the State
authority is unwilling or unable adequately to respond to the emergency.
(June 25, 1947, ch. 125, Sec. 27, as added Pub. L. 95-396, Sec. 24(2),
Sept. 30, 1978, 92 Stat. 837; amended Pub. L. 100-532, title VIII,
Sec. 801(p), Oct. 25, 1988, 102 Stat. 2683.)
Prior Provisions
A prior section 27 of act June 25, 1947, ch. 125, was renumbered
section 34 and is classified to section 136y of this title.
Amendments
1988--Pub. L. 100-532 inserted headings for subsecs. (a) to (c).
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Sec. 136w-3. Identification of pests; cooperation with Department of Agricultures program.
(a) In general
The Administrator, in coordination with the Secretary of
Agriculture, shall identify those pests that must be brought under
control. The Administrator shall also coordinate and cooperate with the
Secretary of Agricultures research and implementation programs to
develop and improve the safe use and effectiveness of chemical,
biological, and alternative methods to combat and control pests that
reduce the quality and economical production and distribution of
agricultural products to domestic and foreign consumers.
(b) Pest control availability
(1) In general
The Administrator, in cooperation with the Secretary of
Agriculture, shall identify--
(A) available methods of pest control by crop or animal;
(B) minor pest control problems, both in minor crops and
minor or localized problems in major crops; and
(C) factors limiting the availability of specific pest
control methods, such as resistance to control methods and
regulatory actions limiting the availability of control methods.
(2) Report
The Secretary of Agriculture shall, not later than 180 days
after November 28, 1990, and annually thereafter, prepare a report
and send the report to the Administrator. The report shall--
(A) contain the information described in paragraph (1);
(B) identify the crucial pest control needs where a shortage
of control methods is indicated by the information described in
paragraph (1); and
(C) describe in detail research and extension efforts
designed to address the needs identified in subparagraph (B).
(c) Integrated pest management
The Administrator, in cooperation with the Secretary of Agriculture,
shall develop approaches to the control of pests based on integrated
pest management that respond to the needs of producers, with a special
emphasis on minor pests.
(d) Public health pests
The Administrator, in coordination with the Secretary of Agriculture
and the Secretary of Health and Human Services, shall identify pests of
significant public health importance and, in coordination with the
Public Health Service, develop and implement programs to improve and
facilitate the safe and necessary use of chemical, biological, and other
methods to combat and control such pests of public health importance.
(June 25, 1947, ch. 125, Sec. 28, as added Pub. L. 95-396, Sec. 24(2),
Sept. 30, 1978, 92 Stat. 838; amended Pub. L. 101-624, title XIV,
Sec. 1495, Nov. 28, 1990, 104 Stat. 3629; Pub. L. 104-127, title VIII,
Sec. 862(b)(1), Apr. 4, 1996, 110 Stat. 1174; Pub. L. 104-170, title II,
Sec. 236, Aug. 3, 1996, 110 Stat. 1509.)
Amendments
1996--Subsec. (b)(2)(A). Pub. L. 104-127 struck out ``and the
information required by section 5882 of this title after ``paragraph
(1).
Subsec. (d). Pub. L. 104-170 added subsec. (d).
1990--Pub. L. 101-624 designated existing provisions as subsec. (a)
and added subsecs. (b) and (c).
Sec. 136w-4. Omitted.
Codification
Section, act June 25, 1947, ch. 125, Sec. 29, as added Pub. L. 95-
396, Sec. 24(2), Sept. 30, 1978, 92 Stat. 838, which required the
Administrator of the Environmental Protection Agency to submit an annual
report to Congress relating to applications filed for conditional
registration under section 136a(c)(7)(B), (C) of this title, terminated,
effective May 15, 2000, pursuant to section 3003 of Pub. L. 104-66, as
amended, set out as a note under section 1113 of Title 31, Money and
Finance. See, also, page 164 of House Document No. 103-7.
Sec. 136w-5. Minimum requirements for training of maintenance applicators and service technicians.
Each State may establish minimum requirements for training of
maintenance applicators and service technicians. Such training may
include instruction in the safe and effective handling and use of
pesticides in accordance with the Environmental Protection Agency
approved labeling, and instruction in integrated pest management
techniques. The authority of the Administrator with respect to minimum
requirements for training of maintenance applicators and service
technicians shall be limited to ensuring that each State understands the
provisions of this section.
(June 25, 1947, ch. 125, Sec. 30, as added Pub. L. 104-170, title I,
Sec. 121(2), Aug. 3, 1996, 110 Stat. 1492.)
Prior Provisions
A prior section 30 of act June 25, 1947, ch. 125, was renumbered
section 33 and is classified to section 136x of this title.
Sec. 136w-6. Environmental Protection Agency minor use program.
(a) The Administrator shall assure coordination of minor use issues
through the establishment of a minor use program within the Office of
Pesticide Programs. Such office shall be responsible for coordinating
the development of minor use programs and policies and consulting with
growers regarding minor use issues and registrations and amendments
which are submitted to the Environmental Protection Agency.
(b) The Office of Pesticide Programs shall prepare a public report
concerning the progress made on the registration of minor uses,
including implementation of the exclusive use as an incentive for
registering new minor uses, within 3 years of the passage of the Food
Quality Protection Act of 1996.
(June 25, 1947, ch. 125, Sec. 31, as added Pub. L. 104-170, title II,
Sec. 210(i), Aug. 3, 1996, 110 Stat. 1500.)
References in Text
The passage of the Food Quality Protection Act of 1996, referred to
in subsec. (b), probably means the date of enactment of Pub. L. 104-170,
which was approved Aug. 3, 1996.
Prior Provisions
A prior section 31 of act June 25, 1947, ch. 125, was renumbered
section 34 and is classified to section 136y of this title.
Sec. 136w-7. Department of Agriculture minor use program.
(a) In general
The Secretary of Agriculture (hereinafter in this section referred
to as the ``Secretary) shall assure the coordination of the
responsibilities of the Department of Agriculture related to minor uses
of pesticides, including--
(1) carrying out the Inter-Regional Project Number 4 (IR-4) as
described in section 450i of this title and the national pesticide
resistance monitoring program established under section 1651 \1\ of
the Food, Agriculture, Conservation, and Trade Act of 1990 (7 U.S.C.
5882);
---------------------------------------------------------------------------
\1\ See References in Text note below.
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(2) supporting integrated pest management research;
(3) consulting with growers to develop data for minor uses; and
(4) providing assistance for minor use registrations,
tolerances, and reregistrations with the Environmental Protection
Agency.
(b) Minor use pesticide data and revolving fund
(1) Minor use pesticide data
(A) Grant authority
The Secretary, in consultation with the Administrator, shall
establish a program to make grants for the development of data
to support minor use pesticide registrations and
reregistrations. The amount of any such grant shall not exceed
\1/2\ of the cost of the project for which the grant is made.
(B) Applicants
Any person who wants to develop data to support minor use
pesticide registrations and reregistrations may apply for a
grant under subparagraph (A). Priority shall be given to an
applicant for such a grant who does not directly receive funds
from the sale of pesticides registered for minor uses.
(C) Data ownership
Any data that is developed under a grant under subparagraph
(A) shall be jointly owned by the Department of Agriculture and
the person who received the grant. Such a person shall enter
into an agreement with the Secretary under which such person
shall share any fee paid to such person under section
136a(c)(1)(F) of this title.
(2) Minor Use Pesticide Data Revolving Fund
(A) Establishment
There is established in the Treasury of the United States a
revolving fund to be known as the Minor Use Pesticide Data
Revolving Fund. The Fund shall be available without fiscal year
limitation to carry out the authorized purposes of this
subsection.
(B) Contents of the Fund
There shall be deposited in the Fund--
(i) such amounts as may be appropriated to support the
purposes of this subsection; and
(ii) fees collected by the Secretary for any data
developed under a grant under paragraph (1)(A).
(C) Authorizations of appropriations
There are authorized to be appropriated for each fiscal year
to carry out the purposes of this subsection $10,000,000 to
remain available until expended.
(June 25, 1947, ch. 125, Sec. 32, as added Pub. L. 104-170, title II,
Sec. 210(j), Aug. 3, 1996, 110 Stat. 1501.)
References in Text
Section 1651 of the Food, Agriculture, Conservation, and Trade Act
of 1990, referred to in subsec. (a)(1), was classified to section 5882
of this title prior to repeal by Pub. L. 104-127, title VIII,
Sec. 862(a), Apr. 4, 1996, 110 Stat. 1174.
Sec. 136x. Severability.
If any provision of this subchapter or the application thereof to
any person or circumstance is held invalid, the invalidity shall not
affect other provisions or applications of this subchapter which can be
given effect without regard to the invalid provision or application, and
to this end the provisions of this subchapter are severable.
(June 25, 1947, ch. 125, Sec. 33, formerly Sec. 26, as added Pub. L. 92-
516, Sec. 2, Oct. 21, 1972, 86 Stat. 998; renumbered Sec. 30, Pub. L.
95-396, Sec. 24(1), Sept. 30, 1978, 92 Stat. 836; renumbered Sec. 33,
Pub. L. 104-170, title I, Sec. 121(1), Aug. 3, 1996, 110 Stat. 1492.)
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Sec. 136y. Authorization of appropriations.
There is authorized to be appropriated to carry out this subchapter
(other than section 136u(a) of this title)--
(1) $83,000,000 for fiscal year 1989, of which not more than
$13,735,500 shall be available for research under this subchapter;
(2) $95,000,000 for fiscal year 1990, of which not more than
$14,343,600 shall be available for research under this subchapter;
and
(3) $95,000,000 for fiscal year 1991, of which not more than
$14,978,200 shall be available for research under this subchapter.
(June 25, 1947, ch. 125, Sec. 34, formerly Sec. 27, as added Pub. L. 92-
516, Sec. 2, Oct. 21, 1972, 86 Stat. 998; amended Pub. L. 94-51, July 2,
1975, 89 Stat. 257; Pub. L. 94-109, Oct. 10, 1975, 89 Stat. 571; Pub. L.
94-140, Sec. 3, Nov. 28, 1975, 89 Stat. 752; renumbered Sec. 31 and
amended Pub. L. 95-396, Secs. 24(1), 25, Sept. 30, 1978, 92 Stat. 836,
838; Pub. L. 96-539, Sec. 3, Dec. 17, 1980, 94 Stat. 3195; Pub. L. 98-
201, Sec. 2, Dec. 2, 1983, 97 Stat. 1380; Pub. L. 99-198, title XVII,
Sec. 1768, Dec. 23, 1985, 99 Stat. 1656; Pub. L. 100-532, title VII,
Sec. 701, Oct. 25, 1988, 102 Stat. 2679; renumbered Sec. 34, Pub. L.
104-170, title I, Sec. 121(1), Aug. 3, 1996, 110 Stat. 1492.)
Codification
Another section 1768 of Pub. L. 99-198 enacted sections 154a and 159
and amended sections 151, 154, and 157 of Title 21, Food and Drugs.
Amendments
1988--Pub. L. 100-532 amended section generally. Prior to amendment,
section read as follows: ``There is authorized to be appropriated to
carry out this subchapter for the period beginning October 1, 1985, and
ending September 30, 1986, $68,604,200 of which not more than
$11,993,100 shall be available for research under this subchapter.
1985--Pub. L. 99-198 substituted provisions authorizing
appropriations of $68,604,200 for fiscal year 1986 of which not more
than $11,993,100 shall be available for research for former provisions
which had authorized appropriations for fiscal years 1973 through 1984.
1983--Pub. L. 98-201 authorized necessary appropriations for period
beginning Oct. 1, 1983, and ending Sept. 30, 1984, not in excess of
$64,200,000.
1980--Pub. L. 96-539 inserted provisions authorizing appropriations
for period beginning Oct. 1, 1979, and ending Sept. 30, 1980, and for
period beginning Oct. 1, 1980, and ending Sept. 30, 1981.
1978--Pub. L. 95-396, Sec. 25, substituted appropriations
authorization of $46,636,000 for period beginning Oct. 1, 1976, and
ending Sept. 30, 1977, for prior authorization of $23,600,000 for period
beginning Oct. 1, 1976, and ending Mar. 31, 1977, and authorized
appropriations of $54,500,000 for period beginning Oct. 1, 1977, and
ending Sept. 30, 1978, and such sums as may be necessary, limited to
$70,000,000, for period beginning Oct. 1, 1978, and ending Sept. 30,
1979.
1975--Pub. L. 94-140 authorized appropriation of $47,868,000 to
carry out provisions of this subchapter for period beginning Oct. 1,
1975, and ending Sept. 30, 1976, and $23,600,000 for period beginning
Oct. 1, 1976, and ending Mar. 31, 1977.
Pub. L. 94-109 inserted provisions authorizing appropriation of
$5,983,500 for period beginning Oct. 1, 1975 and ending Nov. 15, 1975.
Pub. L. 94-51 authorized appropriation of $11,967,000 to carry out
provisions of this subchapter for period beginning July 1, 1975, and
ending Sept. 30, 1975.
Effective Date of 1988 Amendment
Section 701 of Pub. L. 100-532 provided that amendment made by Pub.
L. 100-532 is effective Oct. 1, 1988.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
