Sec. 2. [136] Definitions
For purposes of this Act--
(a) Active Ingredient--The term "active ingredient" means--
(1) in the case of a pesticide other than a plant regulator,
defoliant, or 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 11 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 Act.
(2) Private Applicator.--The term "private applicator" means a
certified applicator who uses or supervises the use of any pesticide
which is classified for restricted use for purposes of producing any
agricultural commodity on property owned or rented by the applicator or
the applicator's 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 or mixture of substances
intended for causing the leaves or foliage to drop from a plant, with or
without causing abscission.
(g) Desiccant.--The term "desiccant" means any substance or mixture of substances
intended for artificially accelerating the drying of plant tissue.
(h) Device.--The term "device" means any instrument or contrivance (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 of the Interior
under Public Law 91-135.
(m) Inert ingredient.--The term "inert ingredient" means an ingredient which is not
active.
(n) Ingredient statement.--The term "ingredient statement" means a statement which
contains--
(1) the name and percentage of each active ingredient, and the
total percentage of all inert ingredients, in the pesticide; and
(2) if the pesticide contains arsenic in any form, a statement
of the percentages of total and water soluble arsenic, 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 arthropods whose members are wingless and
usually have more than six legs, as for example, spiders, mites, ticks,
centipedes, and wood lice.
(p) Label and labeling.--
(1) Label.--The term "label" means the written, printed, or graphic matter
on, or attached to, the pesticide or device or any of its containers
or wrappers.
(2) Labeling.--The term "labeling" means all labels and all other written,
printed, or graphic matter--
(A) accompanying the pesticide or device at any time; or
(B) to which reference is made on the label or in literature
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 25(c)(3);
(C) it is an imitation of, or is offered for sale under the
name of, another pesticide;
(D) its label does not bear the registration number assigned
under section 7 to each establishment in which it was produced;
(E) any word, statement, or other information required by or
under authority of this Act to appear on the label or
labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements,
designs, or graphic matter in the 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 3(d) of this Act, 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 3(d) of this
Act, is adequate to protect health and the environment; or
(H) in the case of a pesticide not registered in accordance
with section 3 of this Act 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 of 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 Act, the registration
number assigned to the pesticide under this Act, and
the use classification; and
(D) the pesticide contains any substance or substances in
quantities highly toxic to man, unless the label shall bear, in
addition to any other matter required by this Act--
(i) the skull and crossbones;
(ii) the word "poison" prominently in red on a
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
25(c)(1).
(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 201(w) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(w)) that has been determined by the
Secretary of Health and Human Services not to be a new animal drug by a
regulation establishing conditions of use for the article, or that is an animal
feed within the meaning of section 201(x) of such Act (21 U.S.C. 321(x)) bearing
or containing a new animal drug. 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 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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.
(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 Act.
(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 Act.
(z) Registration.--The term "registration" includes reregistration.
(aa) State.--The term "State" means a State, the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Trust
Territory of the Pacific Islands, and American Samoa.
(bb) Unreasonable Adverse Effects on the Environment.--The term "unreasonable
adverse effects on the environment" means (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 408 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 346a)./1/ 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
Act, the Administrator shall weigh any risks of the pesticide against the health
risks such as diseases transmitted by the vector to be controlled by the
pesticide.
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/1/ Sec. 304 of P.L. 104-170 amended sec.2 (bb) (7 U.S.C. 136(bb)) by inserting
"1" and ", or (2)" and all that follows through "346a).", without sepcifying the Act that
was being amended. The amendments were executed to this Act to effectuate the probable
intent of Congress.
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(cc) Weed.--The term "weed" means any plant which grows where not wanted.
(dd) Establishment.--The term "establishment" means any place where a pesticide
or device or active ingredient used in producing a pesticide is produced,
or held, for distribution or sale.
(ee) To Use Any Registered Pesticide in a Manner Inconsistent with Its
Labeling.--The term "to use any registered 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 5, 18, or 24 of
this Act, or (6) any use of a pesticide in a manner that the
Administrator determines to be consistent with the purposes of this
Act. After March 31, 1979, the term shall not include the use of
a pesticide for agricultural or forestry purposes at a dilution less
than label dosage unless before or after that date the Administrator
issues a regulation or advisory opinion consistent with the study
provided for in section 27(b) of the Federal Pesticide Act of 1978,
which 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 3(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
3(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.--
(A) that was not registered pursuant to section 3 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 urease production regardless
of the actual use of purpose for, or future use or purpose for, the substance or
mixture.
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) /1/ Maintenance Applicator.--The term "maintenance
applicator" means any individual who, in the principal course of such individual's
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 section
2(e)(2); 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 commercial property.
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/1/ So in original (as added by sec. 120 of P.L. 104-70). This subsection
should probably be "(ii)" and subsequent subsections should be redesignated accordingly.
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(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 or
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 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
346a and 348) or a food additive regulation under section 409 of such Act.
(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 that liquid chemical sterilant products exempt
under subsection (u)), 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.
Sec. 3 [136a] Registration of pesticides.
(a) Requirement of Registration.--Except as provided by this Act, no
person in any State may distribute or sell to any person any pesticide that is
not registered under this Act. 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 Act and that is not the subject of
an experimental use permit under section 5 of this title or an
emergency exemption under section 18 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
Act after the date of enactment of the Federal Pesticide Act of
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 minor uses registered
after the date of enactment of this clause 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
Act, if the Administrator determines that an
applicant has failed to participate in a procedure for
reaching an agreement or in an arbitration proceeding as
required by this subparagraph, or failed to comply with the
terms of an agreement or arbitration decision concerning
compensation under this subparagraph, the 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 enactment of this clause,
except where an applicant or registrant is applying for the
registration is applying for the registration of a pesticide
containing an active ingredient not previously registered.
(vi) With respect to data submitted after the date of
enactment of this clause 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
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 Act, 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 10, within 30 days after
the Administrator registers a pesticide under this Act 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 Administrator's 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 Act, 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
registrant's 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 6(d) of this Act. 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 Administrator's determination with
respect to the disposition of existing stocks is consistent with
this Act. If a hearing is held, a decision after completion
of such hearing shall be final. Notwithstanding any other provision
of this Act, a hearing shall be held and a determination made
within seventy-five days after receipt of a request for such
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 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 4 for the other uses of the pesticide established as of
the date of enactment of the Food Quality Protection Act of 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 Administrator's schedule for issuing a
reregistration eligibility determination required under section 4; 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./1/ 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.
-----------------------------------------------------------------------------------------
/1/ Indentation of the following sentences of this clause is so in the original
(as added by sec. 201(c)(1) of P.L. 104-170). Probably should be indented the same as
flush matter of this clause.
-----------------------------------------------------------------------------------------
(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 the date of enactment of the Food Quality Protection Act of 1996,
for the submission of data under section 4 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 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 6(f)(1). 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 6(f)(2). 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 effects 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 cause 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 the date of enactment of this clause, 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 the date of enactment
of this subparagraph, 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) Time for Acting with Respect to 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 Administrator's determination that it does not
comply with the provisions of the Act 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 18 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 Administrator's 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)--
(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 Act;
(C) it will perform its intended function without unreasonable adverse effects on
the environment; and
(D) when used in accordance with widespread and commonly recognized practice it
will not generally cause unreasonable adverse effects on the environment.
The Administrator shall not make any lack of essentiality a
criterion for denying registration of any pesticide. Where two
pesticides meet the 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 pesticide's composition is such as to warrant proposed
claims of efficacy. If a pesticide is found to be efficacious by any
State under section 24(c) of this Act, a presumption is
established that the Administrator shall waive data requirements
pertaining to efficacy for use of the 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 Administrator's determination and of the Administrator's
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 Administrator's decision
and of the Administrator's reasons (including the factual basis) therefor. The
Administrator shall promptly publish in the Federal Register notice of such denial of
registration and the reasons therefor. Upon such notification, the applicant for
registration or other interested person with the concurrence of the applicant shall have
the same remedies as provided for in section 6.
(7) Registration under Special Circumstances.--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, (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 Act.
(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 Act, and during the pendency of any risk-benefit evaluation
initiated by such notice, if (I) the additional use of such pesticide involves a major
food or feed crop, or (II) the additional use of such pesticide involves a minor food
or feed crop and the Administrator determines, with the concurrence of the Secretary
of Agriculture, there is available an effective alternative pesticide that does not
meet or exceed such risk criteria. An applicant seeking amended registration under
this 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 Act.
(C) The Administrator may conditionally register a pesticide containing an active
ingredient not contained in any currently registered pesticide for a period reasonably
sufficient for the 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 Act, 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 Act,
the Administrator may not initiate a public interim administrative review process to
develop a risk-benefit evaluation of the ingredients of a pesticide or any of its uses
prior to initiating a formal action to cancel, suspend, or deny registration of such
pesticide, required under this Act, unless such interim administrative process is based
on a 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 Act 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 Act 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 the date of enactment of this paragraph, 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 6(b).
(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 registrant's position that restricted
use classification is unnecessary because classification of the pesticide for general
use would not cause unreasonable adverse effects on the environment. The Administrator,
within sixty days after receiving such petition, shall notify the registrant whether
the petition has been granted or denied. Any denial shall contain an explanation
therefor and any such denial shall be subject to judicial review under section 16 of
this Act.
(e) Products with Same Formulation and Claims.--Products which have the same formulation,
are manufactured by the same person, the labeling of which contains the same claims, and
the labels of which bear a designation identifying the product as the same pesticide may
be registered as a single pesticide; and additional names and labels shall be added to
the registration by supplemental statements.
(f) Miscellaneous.--
(1) Effect of Change of Labeling or Formulation.--If the labeling or formulation for a
pesticide is changed, the registration shall be amended to reflect such change if the
Administrator determines that the change will not violate any provision of this Act.
(2) Registration Not a Defense.--In no event shall registration of an article be
construed as a defense for the commission of any offense under this Act. As long as no
cancellation proceedings are in effect registration of a pesticide shall be prima facie
evidence that the pesticide, its labeling and packaging comply with the registration
provisions of the Act.
(3) Authority to Consult Other Federal Agencies.--In connection with consideration of
any registration or application for registration under this section, the Administrator may
consult with any other Federal agency.
(4) Mixtures of Nitrogen Stabilizers and Fertilizer Products.--Any mixture or other
combination of--
(A) 1 or more nitrogen stabilizers registered under this Act; and
(B) 1 or more fertilizer products,
shall not be subject to the provisions of this section or sections 4, 5, 7, 15, and
17(a)(2) if the mixture or other combination is accompanied by the labeling required
under this Act 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)(A) General Rule.--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 pesticide's 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 6.
(B) Limitation.--Nothing in this subsection shall prohibit the Administrator from
undertaking any other review of a pesticide pursuant to this Act.
(2)(A) Data.--The Administrator shall use the authority in subsection (c)(2)(B) 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) 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 the
date of enactment of this subsection 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 the date of enactment of this
subsection, 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
Act, 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).
(D) Alternative Review Periods.--If the final regulations to carry out this
paragraph are not effective 630 days after the date of enactment of this subsection,
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 2(mm) of this 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, United States Code.
(iii) Exemption.--This subparagraph does not apply to an application for an
antimicrobial pesticide that is filed under subsection (c)(3)(B) prior to 90 days
after the date of enactment of this subsection.
(4) Annual Report.--
(A) Submission.--Beginning on the date of enactment of this subsection 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.
Sec. 4. [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 3(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 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 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).
(4) The fourth phase shall include an independent, initial
review by the Administrator under subsection (f) 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 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), 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) whether the registrants intend
to seek or not to seek reregistration of such pesticides.
(d) Phase Two.--
(1) In General.--The registrant of a pesticide that contains an active ingredient
listed under subparagraph (B), (C), or (D) of subsection (c)(2) shall submit to the
Administrator, within the time period prescribed by paragraph (4), the notice
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) 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) 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 3, 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
&nb