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ICR ATTACHMENT D
40 CFR part 152: Pesticide Registration and Classification Procedures
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PART 152—PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES
Section Contents
Subpart A—General Provisions
§ 152.1 Scope.
§ 152.3 Definitions.
§ 152.5 Pests.
§ 152.6 Substances excluded from regulation by FIFRA.
§ 152.8 Products that are not pesticides because they are not for use against pests.
§ 152.10 Products that are not pesticides because they are not deemed to be used for a
pesticidal effect.
§ 152.15 Pesticide products required to be registered.
Subpart B—Exemptions
§ 152.20 Exemptions for pesticides regulated by another Federal agency.
§ 152.25 Exemptions for pesticides of a character not requiring FIFRA regulation.
§ 152.30 Pesticides that may be transferred, sold, or distributed without registration.
Subpart C—Registration Procedures
§ 152.40
§ 152.42
§ 152.43
§ 152.44
§ 152.46
§ 152.50
§ 152.55
Who may apply.
Application for new registration.
Alternate formulations.
Application for amended registration.
Notification and non-notification changes to registrations.
Contents of application.
Where to send applications and correspondence.
Subpart D [Reserved]
Subpart E—Procedures To Ensure Protection of Data Submitters' Rights
§ 152.80
§ 152.81
§ 152.83
§ 152.84
§ 152.85
General.
Applicability.
Definitions.
When materials must be submitted to the Agency.
Formulators' exemption.
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§ 152.86
§ 152.90
§ 152.91
§ 152.92
§ 152.93
§ 152.94
§ 152.95
§ 152.96
§ 152.97
§ 152.98
§ 152.99
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The cite-all method.
The selective method.
Waiver of a data requirement.
Submission of a new valid study.
Citation of a previously submitted valid study.
Citation of a public literature study or study generated at government expense.
Citation of all studies in the Agency's files pertinent to a specific data requirement.
Documentation of a data gap.
Rights and obligations of data submitters.
Procedures for transfer of exclusive use or compensation rights to another person.
Petitions to cancel registration.
Subpart F—Agency Review of Applications
§ 152.100 Scope.
§ 152.102 Publication.
§ 152.104 Completeness of applications.
§ 152.105 Incomplete applications.
§ 152.107 Review of data.
§ 152.108 Review of labeling.
§ 152.110 Time for Agency review.
§ 152.111 Choice of standards for review of applications.
§ 152.112 Approval of registration under FIFRA sec. 3(c)(5).
§ 152.113 Approval of registration under FIFRA sec. 3(c)(7)—Products that do not contain a
new active ingredient.
§ 152.114 Approval of registration under FIFRA sec. 3(c)(7)—Products that contain a new
active ingredient.
§ 152.115 Conditions of registration.
§ 152.116 Notice of intent to register to original submitters of exclusive use data.
§ 152.117 Notification to applicant.
§ 152.118 Denial of application.
§ 152.119 Availability of material in support of registration.
Subpart G—Obligations and Rights of Registrants
§ 152.122
§ 152.125
§ 152.130
§ 152.132
§ 152.135
Currency of address of record and authorized agent.
Submission of information pertaining to adverse effects.
Distribution under approved labeling.
Supplemental distribution.
Transfer of registration.
Subpart H [Reserved]
Subpart I—Classification of Pesticides
§ 152.160
§ 152.161
§ 152.164
§ 152.166
§ 152.167
§ 152.168
§ 152.170
§ 152.171
§ 152.175
Scope.
Definitions.
Classification procedures.
Labeling of restricted use products.
Distribution and sale of restricted use products.
Advertising of restricted use products.
Criteria for restriction to use by certified applicators.
Restrictions other than those relating to use by certified applicators.
Pesticides classified for restricted use.
Subparts J–T [Reserved]
Subpart U—Registration Fees
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§ 152.400
§ 152.401
§ 152.403
§ 152.404
§ 152.406
§ 152.408
§ 152.410
§ 152.412
§ 152.414
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Purpose.
Inapplicability of fee provisions to applications filed prior to October 1, 1997.
Definitions of fee categories.
Fee amounts.
Submission of supplementary data.
Special considerations.
Adjustment of fees.
Waivers and refunds.
Procedures.
Subparts V–Y [Reserved]
Subpart Z—Devices
§ 152.500 Requirements for devices.
Authority: 7 U.S.C. 136–136y; Subpart U is also issued under 31 U.S.C. 9701.
Subpart A—General Provisions
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Source: 53 FR 15975, May 4, 1988, unless otherwise noted.
§ 152.1 Scope.
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Except as provided in part 174, part 152 sets forth procedures, requirements, and criteria concerning the
registration and reregistration of pesticide products under FIFRA sec. 3, and for associated regulatory
activities affecting registration. These latter regulatory activities include data compensation and
exclusive use (subpart E), and the classification of pesticide uses (subpart I). Part 152 also sets forth
procedures, requirements, and criteria applicable to plant-incorporated protectants. Unless specifically
superseded by part 174, the regulations in part 152 apply to plant-incorporated protectants.
[66 FR 37814, July 19, 2001]
§ 152.3 Definitions.
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Terms used in this part have the same meaning as in the Act. In addition, the following terms have the
meanings set forth in this section.
Act or FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C.
136–136y).
Active ingredient means any substance (or group of structurally similar substances if specified by the
Agency) that will prevent, destroy, repel or mitigate any pest, or that functions as a plant regulator,
desiccant, or defoliant within the meaning of FIFRA sec. 2(a), except as provided in §174.3 of this
chapter.
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Acute dermal LD 50means a statistically derived estimate of the single dermal dose of a substance that
would cause 50 percent mortality to the test population under specified conditions.
Acute inhalation LC 50means a statistically derived estimate of the concentration of a substance that
would cause 50 percent mortality to the test population under specified conditions.
Acute oral LD 50means a statistically derived estimate of the single oral dose of a substance that would
cause 50 percent mortality to the test population under specified conditions.
Administrator means the Administrator of the United States Environmental Protection Agency or his
delegate.
Agency means the United States Environmental Protection Agency (EPA), unless otherwise specified.
Applicant means a person who applies for a registration, amended registration, or reregistration, under
FIFRA sec. 3.
Biological control agent means any living organism applied to or introduced into the environment that is
intended to function as a pesticide against another organism declared to be a pest by the Administrator.
Distribute or sell and other grammatical variations of the term such as “distributed or sold” and
“distribution or sale,” means the acts of distributing, selling, offering for sale, holding for sale, shipping,
holding for shipment, delivering for shipment, or receiving and (having so received) delivering or offering
to deliver, or releasing for shipment to any person in any State.
End use product means a pesticide product whose labeling
(1) Includes directions for use of the product (as distributed or sold, or after combination by the user with
other substances) for controlling pests or defoliating, desiccating, or regulating the growth of plants, and
(2) Does not state that the product may be used to manufacture or formulate other pesticide products.
Final printed labeling means the label or labeling of the product when distributed or sold. Final printed
labeling does not include the package of the product, unless the labeling is an integral part of the
package.
Genetic material necessary for the production means both: Genetic material that encodes a substance
or leads to the production of a substance, and regulatory regions. It does not include noncoding,
nonexpressed nucleotide sequences.
In a living plant means inside the living plant, on the surface of the living plant, or as an exudate from the
living plant.
Inert ingredient means any substance (or group of structurally similar substances if designated by the
Agency), other than an active ingredient, which is intentionally included in a pesticide product, except as
provided by §174.3 of this chapter.
Institutional use means any application of a pesticide in or around any property or facility that functions
to provide a service to the general public or to public or private organizations, including but not limited to:
(1) Hospitals and nursing homes.
(2) Schools other than preschools and day care facilities.
(3) Museums and libraries.
(4) Sports facilities.
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(5) Office buildings.
Living plant means a plant, plant organ, or plant part that is alive, viable, or dormant. Examples of plant
parts include, but are not limited to, seeds, fruits, leaves, roots, stems, flowers, and pollen.
Manufacturing use product means any pesticide product that is not an end-use product.
New use, when used with respect to a product containing a particular active ingredient, means:
(1) Any proposed use pattern that would require the establishment of, the increase in, or the exemption
from the requirement of, a tolerance or food additive regulation under section 408 or 409 of the Federal
Food, Drug and Cosmetic Act;
(2) Any aquatic, terrestrial, outdoor, or forestry use pattern, if no product containing the active ingredient
is currently registered for that use pattern; or
(3) Any additional use pattern that would result in a significant increase in the level of exposure, or a
change in the route of exposure, to the active ingredient of man or other organisms.
Noncoding, nonexpressed nucleotide sequences means the nucleotide sequences are not transcribed
and are not involved in gene expression. Examples of noncoding, nonexpressed nucleotide sequences
include, but are not limited to, linkers, adapters, homopolymers, and sequences of restriction enzyme
recognition sites.
Operated by the same producer, when used with respect to two establishments, means that each such
establishment is either owned by, or leased for operation by and under the control of, the same person.
The term does not include establishments owned or operated by different persons, regardless of
contractural agreement between such persons.
Package or packaging means the immediate container or wrapping, including any attached closure(s), in
which the pesticide is contained for distribution, sale, consumption, use, or storage. The term does not
include any shipping or bulk container used for transporting or delivering the pesticide unless it is the
only such package.
Pesticidal substance, when referring to a plant-incorporated protectant only, means a substance that is
intended to be produced and used in a living plant, or in the produce thereof, for a pesticidal purpose
during any part of a plant's life cyle (e.g., in the embryo, seed, seedling, mature plant).
Pesticide means any substance or mixture of substances intended for preventing, destroying, repelling,
or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant, other than any
article that:
(1) Is a new animal drug under FFDCA sec. 201(w), or
(2) Is an animal drug that has been determined by regulation of the Secretary of Health and Human
Services not to be a new animal drug, or
(3) Is an animal feed under FFDCA sec. 201(x) that bears or contains any substances described by
paragraph (s) (1) or (2) of this section.
Pesticide product means a pesticide in the particular form (including composition, packaging, and
labeling) in which the pesticide is, or is intended to be, distributed or sold. The term includes any
physical apparatus used to deliver or apply the pesticide if distributed or sold with the pesticide.
Plant-incorporated protectant means a pesticidal substance that is intended to be produced and used in
a living plant, or in the produce thereof, and the genetic material necessary for production of such a
pesticidal substance. It also includes any inert ingredient contained in the plant, or produce thereof.
Produce thereof, when referring to plant-incorporated protectants only, means a product of a living plant
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containing a plant-incorporated protectant, where the pesticidal substance is intended to serve a
pesticidal purpose after the product has been separated from the living plant. Examples of such products
include, but are not limited to, agricultural produce, grains, and lumber. Products such as raw agricultural
commodities bearing pesticide chemical residues are not “produce thereof” when the residues are not
intended to serve a pesticidal purpose in the produce.
Regulatory region means genetic material that controls the expression of the genetic material that
encodes a pesticidal substance or leads to the production of a pesticidal substance. Examples of
regulatory regions include, but are not limited to, promoters, enhancers, and terminators.
Residential use means use of a pesticide directly:
(1) On humans or pets,
(2) In, on, or around any structure, vehicle, article, surface, or area associated with the household,
including but not limited to areas such as non-agricultural outbuildings, non-commercial greenhouses,
pleasure boats and recreational vehicles, or
(3) In any preschool or day care facility.
[53 FR 15975, May 4, 1988, as amended at 66 FR 37814, July 19, 2001]
§ 152.5 Pests.
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An organism is declared to be a pest under circumstances that make it deleterious to man or the
environment, if it is:
(a) Any vertebrate animal other than man;
(b) Any invertebrate animal, including but not limited to, any insect, other arthropod, nematode, or
mollusk such as a slug and snail, but excluding any internal parasite of living man or other living animals;
(c) Any plant growing where not wanted, including any moss, alga, liverwort, or other plant of any higher
order, and any plant part such as a root; or
(d) Any fungus, bacterium, virus, or other microorganism, except for those on or in living man or other
living animals and those on or in processed food or processed animal feed, beverages, drugs (as
defined in FFDCA sec. 201(g)(1)) and cosmetics (as defined in FFDCA sec. 201(i)).
§ 152.6 Substances excluded from regulation by FIFRA.
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Products and substances listed in this section are excluded from FIFRA regulation if they meet the
specified conditions or criteria.
(a) Liquid chemical sterilants. A liquid chemical sterilant product is not a pesticide under section 2(u) of
FIFRA if it meets all of the following criteria. Excluded products are regulated by the Food and Drug
Administration (FDA). Products excluded are those meeting all of the following criteria:
(1) Composition. The product must be in liquid form as sold or distributed. Pressurized gases or
products in dry or semi-solid form are not excluded by this provision. Ethylene oxide products are not
liquid products and are not excluded by this provision.
(2) Claims. The product must bear a sterilant claim, or a sterilant plus subordinate level disinfection
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claim. Products that bear antimicrobial claims solely at a level less than “sterilant” are not excluded and
are jointly regulated by EPA and FDA. “Sterilant” is defined in §156.441 of this chapter.
(3) Use site. (i) The product must be intended and labeled only for use on “critical or semi-critical
devices.” A “critical device” is 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. A semi-critical device is 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.
(ii) Liquid chemical sterilants that bear claims solely for use on non-critical medical devices are jointly
regulated by EPA and FDA.
(iii) Liquid chemical sterilants that bear claims solely for use on sites that are not medical devices, such
as veterinary equipment, are not excluded and are regulated solely by EPA.
(b) Nitrogen stabilizers. A nitrogen stabilizer is excluded from regulation under FIFRA if it is a substance
(or mixture of substances), meeting all of the following criteria:
(1) The substance prevents or hinders the process of nitrification, denitrification, ammonia volatilization,
or urease production through action affecting soil bacteria and is distributed and sold solely for those
purposes and no other pesticidal purposes. For purposes of this section, living organisms are not
considered to be substances, and the actions of living organisms are not relevant to whether a
substance is deemed to be a nitrogen stabilizer.
(2) The substance was in “commercial agronomic use” in the United States before January 1, 1992. EPA
considers a substance to be in commercial agronomic use if it is available for sale or distribution to users
for direct agronomic benefit, as opposed to limited research, experimental or demonstration use.
(3) The substance was not registered under FIFRA before January 1, 1992.
(4) Since January 1, 1992, the distributor or seller has made no claim that the product prevents or
hinders the process of nitrification, denitrification, ammonia volatilization or urease production. EPA
considers any of the following claims (or their equivalents) to be a claim that the product prevents or
hinders nitrification, denitrification, ammonia volatilization or urease production:
(i) Improves crop utilization of applied nitrogen.
(ii) Reduces leaching of applied nitrogen or reduces groundwater nitrogen contamination.
(iii) Prevents nitrogen loss.
(iv) Prolongs availability of nitrogen.
(v) Increases nitrogen uptake, availability, usage, or efficiency.
(5) A product will be considered to have met the criterion of paragraph (b)(4) of this section that no
nitrogen stabilization claim has been made if:
(i) The nitrogen stabilization claim, in whatever terms expressed, is made solely in compliance with a
State requirement to include the claim in materials required to be submitted to a State legislative or
regulatory authority, or in the labeling or other literature accompanying the product; and
(ii) The State requirement to include the claim was in effect both before the product bearing the claim
was introduced into commercial agronomic use, and before the effective date of this rule.
(6) A product that meets all of the criteria of this paragraph with respect to one State is not thereby
excluded from FIFRA regulation if distributed and sold in another State whose nitrogen stabilization
statement requirement does not meet the requirements of paragraph (b)(5)(ii) of this section.
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(c) Human drugs. Fungi, bacteria, viruses or other microorganisms in or on living man are not “pests” as
defined in section 2(t) of FIFRA. Products intended and labeled for use against such organisms are
human drugs subject to regulation by the FDA under the FFDCA.
(d) Animal drugs. (1) Fungi, viruses, bacteria or other microorganisms on or in living animals are not
“pests” under section 2(t) of FIFRA. Products intended for use against such organisms are “animal
drugs” regulated by the FDA under the FFDCA.
(2) A “new animal drug” as defined in section 201(w) of the FFDCA, or an animal drug that FDA has
determined is not a “new animal drug” is not a pesticide under section 2(u) of FIFRA. Animal drugs are
regulated by the FDA under the FFDCA.
(e) Animal feeds. An animal feed containing a new animal drug is not a pesticide under section 2(u) of
FIFRA. An animal feed containing a new animal drug is subject to regulation by the FDA under the
FFDCA.
(f) Vitamin hormone products. A product consisting of a mixture of plant hormones, plant nutrients,
inoculants, or soil amendments is not a “plant regulator” under section 2(v) of FIFRA, provided it meets
the following criteria:
(1) The product, in the undiluted package concentration at which it is distributed or sold, meets the
criteria of §156.62 of this chapter for Toxicity Category III or IV; and
(2) The product is not intended for use on food crop sites, and is labeled accordingly.
(g) Products intended to aid the growth of desirable plants. A product of any of the following types,
intended only to aid the growth of desirable plants, is not a “plant regulator” under section 2(v) of FIFRA,
and therefore is not a pesticide:
(1) A plant nutrient product, consisting of one or more macronutrients or micronutrient trace elements
necessary to normal growth of plants and in a form readily usable by plants.
(2) A plant inoculant product consisting of microorganisms to be applied to the plant or soil for the
purpose of enhancing the availability or uptake of plant nutrients through the root system.
(3) A soil amendment product containing a substance or substances intended for the purpose of
improving soil characteristics favorable for plant growth.
[66 FR 64763, Dec. 14, 2001]
§ 152.8 Products that are not pesticides because they are not for use against pests.
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A substance or article is not a pesticide, because it is not intended for use against “pests” as defined in
§152.5, if it is:
(a) A fertilizer product not containing a pesticide.
(b) A product intended to force bees from hives for the collection of honey crops.
[53 FR 15975, May 4, 1988, as amended at 66 FR 64764, Dec. 14, 2001]
§ 152.10 Products that are not pesticides because they are not deemed to be used for
a pesticidal effect.
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A product that is not intended to prevent, destroy, repel, or mitigate a pest, or to defoliate, desiccate or
regulate the growth of plants, is not considered to be a pesticide. The following types of products or
articles are not considered to be pesticides unless a pesticidal claim is made on their labeling or in
connection with their sale and distribution:
(a) Deodorizers, bleaches, and cleaning agents;
(b) Products not containing toxicants, intended only to attract pests for survey or detection purposes,
and labeled accordingly;
(c) Products that are intended to exclude pests only by providing a physical barrier against pest access,
and which contain no toxicants, such as certain pruning paints to trees.
§ 152.15 Pesticide products required to be registered.
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No person may distribute or sell any pesticide product that is not registered under the Act, except as
provided in §§152.20, 152.25, and 152.30. A pesticide is any substance (or mixture of substances)
intended for a pesticidal purpose, i.e. , use for the purpose of preventing, destroying, repelling, or
mitigating any pest or use as a plant regulator, defoliant, or desiccant. A substance is considered to be
intended for a pesticidal purpose, and thus to be a pesticide requiring registration, if:
(a) The person who distributes or sells the substance claims, states, or implies (by labeling or
otherwise):
(1) That the substance (either by itself or in combination with any other substance) can or should be
used as a pesticide; or
(2) That the substance consists of or contains an active ingredient and that it can be used to
manufacture a pesticide; or
(b) The substance consists of or contains one or more active ingredients and has no significant
commercially valuable use as distributed or sold other than (1) use for pesticidal purpose (by itself or in
combination with any other substance), (2) use for manufacture of a pesticide; or
(c) The person who distributes or sells the substance has actual or constructive knowledge that the
substance will be used, or is intended to be used, for a pesticidal purpose.
Subpart B—Exemptions
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Source: 53 FR 15977, May 4, 1988, unless otherwise noted.
§ 152.20 Exemptions for pesticides regulated by another Federal agency.
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The pesticides or classes of pesticide listed in this section are exempt from all requirements of FIFRA.
The Agency has determined, in accordance with FIFRA sec. 25(b)(1), that they are adequately regulated
by another Federal agency.
(a) Certain biological control agents. (1) Except as provided by paragraphs (a)(3) and (a)(4) of this
section, all biological control agents are exempt from FIFRA requirements.
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(2) If the Agency determines that an individual biological control agent or class of biological control
agents is no longer adequately regulated by another Federal agency, and that it should not otherwise be
exempted from the requirements of FIFRA, the Agency will revoke this exemption by amending
paragraph (a)(3) of this section.
(3) The following biological control agents are not exempt from FIFRA requirements:
(i) A eucaryotic microorganism including, but not limited to, protozoa, algae and fungi;
(ii) A procaryotic microorganism including, but not limited to, Eubacteria and Archaebacteria; or
(iii) A parasitically-replicating microscopic element, including, but not limited to, viruses.
(4) All living plants intended for use as biological control agents are exempt from the requirements of
FIFRA. However, plant-incorporated protectants are not exempt pursuant to this section. Regulations,
including exemptions, for plant-incorporated protectants are addressed in part 174 of this chapter.
(b) Non-liquid chemical sterilants. A non-liquid chemical sterilant, except ethylene oxide, that meets the
criteria of §152.6(a)(2) with respect to its claims and §152.6(a)(3) with respect to its use sites is
exempted from regulation under FIFRA.
[53 FR 15977, May 4, 1988, as amended at 66 FR 37814, July 19, 2001; 66 FR 64764, Dec. 14, 2001;
72 FR 61027, Oct. 26, 2007]
§ 152.25 Exemptions for pesticides of a character not requiring FIFRA regulation.
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The pesticides or classes of pesticides listed in this section have been determined to be of a character
not requiring regulation under FIFRA, and are therefore exempt from all provisions of FIFRA when
intended for use, and used, only in the manner specified.
(a) Treated articles or substances. An article or substance treated with, or containing, a pesticide to
protect the article or substance itself (for example, paint treated with a pesticide to protect the paint
coating, or wood products treated to protect the wood against insect or fungus infestation), if the
pesticide is registered for such use.
(b) Pheromones and pheromone traps. Pheromones and identical or substantially similar compounds
labeled for use only in pheromone traps (or labeled for use in a manner which the Administrator
determines poses no greater risk of adverse effects on the environment than use in pheromone traps),
and pheromone traps in which those compounds are the sole active ingredient(s).
(1) For the purposes of this paragraph, a pheromone is a compound produced by an arthropod which,
alone or in combination with other such compounds, modifies the behavior of other individuals of the
same species.
(2) For the purposes of this paragraph, a synthetically produced compound is identical to a pheromone
only when their molecular structures are identical, or when the only differences between the molecular
structures are between the stereochemical isomer ratios of the two compounds, except that a synthetic
compound found to have toxicological properties significantly different from a pheromone is not identical.
(3) When a compound possesses many characteristics of a pheromone but does not meet the criteria in
paragraph (a)(2) of this section, it may, after review by the Agency, be deemed a substantially similar
compound.
(4) For the purposes of this paragraph, a pheromone trap is a device containing a pheromone or an
identical or substantially similar compound used for the sole purpose of attracting, and trapping or killing,
target arthropods. Pheromone traps are intended to achieve pest control by removal of target organisms
from their natural environment and do not result in increased levels of pheromones or identical or
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substantially similar compounds over a significant fraction of the treated area.
(c) Preservatives for biological specimens. (1) Embalming fluids.
(2) Products used to preserve animal or animal organ specimens, in mortuaries, laboratories, hospitals,
museums and institutions of learning.
(3) Products used to preserve the integrity of milk, urine, blood, or other body fluids for laboratory
analysis.
(d) Foods. Products consisting of foods and containing no active ingredients, which are used to attract
pests.
(e) Natural cedar. (1) Natural cedar blocks, chips, shavings, balls, chests, drawer liners, paneling, and
needles that meet all of the following criteria:
(i) The product consists totally of cedarwood or natural cedar.
(ii) The product is not treated, combined, or impregnated with any additional substance(s).
(iii) The product bears claims or directions for use solely to repel arthropods other than ticks or to retard
mildew, and no additional claims are made in sale or distribution. The labeling must be limited to specific
arthropods, or must exclude ticks if any general term such as “arthropods,” “insects,” “bugs,” or any
other broad inclusive term, is used. The exemption does not apply to natural cedar products claimed to
repel ticks.
(2) The exemption does not apply to cedar oil, or formulated products which contain cedar oil, other
cedar extracts, or ground cedar wood as part of a mixture.
(f) Minimum risk pesticides —(1) Exempted products. Products containing the following active
ingredients are exempt from the requirements of FIFRA, alone or in combination with other substances
listed in this paragraph, provided that all of the criteria of this section are met.
Castor oil (U.S.P. or equivalent)
Cedar oil
Cinnamon and cinnamon oil
Citric acid
Citronella and citronella oil
Cloves and clove oil
Corn gluten meal
Corn oil
Cottonseed oil
Dried blood
Eugenol
Garlic and garlic oil
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Geraniol
Geranium oil
Lauryl sulfate
Lemongrass oil
Linseed oil
Malic acid
Mint and mint oil
Peppermint and peppermint oil
2-Phenethyl propionate (2-phenylethyl propionate)
Potassium sorbate
Putrescent whole egg solids
Rosemary and rosemary oil
Sesame (includes ground sesame plant) and sesame oil
Sodium chloride (common salt)
Sodium lauryl sulfate
Soybean oil
Thyme and thyme oil
White pepper
Zinc metal strips (consisting solely of zinc metal and impurities)
(2) Permitted inerts . A pesticide product exempt under paragraph (f)(1) of this section may only include
inert ingredients listed in the most current List 4A. This list is updated periodically. The most current list
may be obtained by contacting the Registration Division at the appropriate address as set forth in 40
CFR 150.17(a) or (b).
(3) Other conditions of exemption. All of the following conditions must be met for products to be
exempted under this section:
(i) Each product containing the substance must bear a label identifying the name and percentage (by
weight) of each active ingredient and the name of each inert ingredient.
(ii) The product must not bear claims either to control or mitigate microorganisms that pose a threat to
human health, including but not limited to disease transmitting bacteria or viruses, or claims to control
insects or rodents carrying specific diseases, including, but not limited to ticks that carry Lyme disease.
(iii) The product must not include any false and misleading labeling statements, including those listed in
40 CFR 156.10(a)(5)(i) through (viii).
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[53 FR 15977, May 4, 1988, as amended at 59 FR 2751, Jan. 19, 1994; 61 FR 8878, Mar. 6, 1996; 66
FR 64764, Dec. 14, 2001; 71 FR 35545, June 21, 2006]
§ 152.30 Pesticides that may be transferred, sold, or distributed without registration.
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An unregistered pesticide, or a pesticide whose registration has been cancelled or suspended, may be
dis-tributed or sold, or otherwise transferred, to the extent described by this section.
(a) A pesticide transferred between registered establishments operated by the same producer. An
unregistered pesticide may be transferred between registered establishments operated by the same
producer. The pesticide as transferred must be labeled in accordance with part 156 of this chapter.
(b) A pesticide transferred between registered establishments not operated by the same producer. An
unregistered pesticide may be transferred between registered establishments not operated by the same
producer if:
(1) The transfer is solely for the purpose of further formulation, packaging, or labeling into a product that
is registered;
(2) Each active ingredient in the pesticide, at the time of transfer, is present as a result of incorporation
into the pesticide of either:
(i) A registered product; or
(ii) A pesticide that is produced by the registrant of the final product; and
(3) The product as transferred is labeled in accordance with part 156 of this chapter.
(c) A pesticide distributed or sold under an experimental use permit. (1) An unregistered pesticide may
be distributed or sold in accordance with the terms of an experimental use permit issued under FIFRA
sec. 5, if the product is labeled in accordance with §172.6 of this chapter.
(2) An unregistered pesticide may be distributed or sold in accordance with the provisions of §172.3 of
this chapter, pertaining to use of a pesticide for which an experimental use permit is not required,
provided the product is labeled in accordance with part 156 of this chapter.
(d) A pesticide transferred solely for export. An unregistered pesticide may be transferred within the
United States solely for export if it meets the following conditions:
(1) The product is prepared and packaged according to the specifications of the foreign purchaser; and
(2) The product is labeled in accordance with part 156 of this chapter.
(e) A pesticide distributed or sold under an emergency exemption. An unregistered pesticide may be
distributed or sold in accordance with the terms of an emergency exemption under FIFRA sec. 18, if the
product is labeled in accordance with part 156 of this chapter.
(f) A pesticide transferred for purposes of disposal. An unregistered, suspended, or cancelled pesticide
may be transferred solely for disposal in accordance with FIFRA sec. 19 or an applicable Administrator's
order. The product must be labeled in accordance with part 156 of this chapter.
(g) Existing stocks of a formerly registered product. A cancelled or suspended pesticide may be
distributed or sold to the extent and in the manner specified in an order issued by the Administrator
concerning existing stocks of the pecticide.
Subpart C—Registration Procedures
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top
Source: 53 FR 15978, May 4, 1988, unless otherwise noted.
§ 152.40 Who may apply.
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Any person may apply for new registration of a pesticide product. Any registrant may apply for
amendment of the registration of his product.
§ 152.42 Application for new registration.
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Any person seeking to obtain a registration for a new pesticide product must submit an application for
registration, containing the information specified in §152.50. An application for new registration must be
approved by the Agency before the product may legally be distributed or sold, except as provided by
§152.30.
§ 152.43 Alternate formulations.
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(a) A product proposed for registration must have a single, defined composition, except that EPA may
approve a basic formulation and one or more alternate formulations for a single product.
(b) An alternate formulation must meet the criteria listed in paragraph (b) (1) through (4) of this section.
The Agency may require the submission of data to determine whether the criteria have been met.
(1) The alternate formulation must have the same certified limits for each active ingredient as the basic
formulation.
(2) If the alternate formulation contains an inert ingredient or impurity of toxicological signficance, the
formulation must have the same upper certified limit for that substance as the basic formulation;
(3) The label text of the alternate formulation product must be identical to that of the basic formulation.
(4) The analytical method required under §158.355 of this chapter must be suitable for use on both the
basic formulation and the alternate formulation.
(c) Notwithstanding the criteria in this section, the Agency may determine that an alternate formulation
must be separately registered. If EPA makes this determination, the Agency will notify the applicant of its
determination and its reasons. Thereafter the application for an alternate formulation will be treated as
an application for new registration, and the alternate formulation will be assigned a new registration
number.
[53 FR 15978, May 4, 1988, as amended at 72 FR 61027, Oct. 26, 2007]
§ 152.44 Application for amended registration.
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(a) Except as provided by §152.46, any modification in the composition, labeling, or packaging of a
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registered product must be submitted with an application for amended registration. The applicant must
submit the information required by §152.50, as applicable to the change requested. If an application for
amended registration is required, the application must be approved by the Agency before the product,
as modified, may legally be distributed or sold.
(b) In its discretion, the Agency may:
(1) Waive the requirement for submission of an application for amended registration;
(2) Require that the applicant certify to the Agency that he has complied with an Agency directive rather
than submit an application for amended registration; or
(3) Permit an applicant to modify a registration by notification or non-notification in accordance with
§152.46.
(c) A registrant may at any time submit identical minor labeling amendments affecting a number of
products as a single application if no data are required for EPA to approve the amendment (for example,
a change in the wording of a storage statement for designated residential use products). A consolidated
application must clearly identify the labeling modification(s) to be made (which must be identical for all
products included in the application), list the registration number of each product for which the
modification is requested, and provide required supporting materials (for example, labeling) for each
affected product.
[53 FR 15978, May 4, 1988, as amended at 61 FR 33041, June 26, 1996; 66 FR 64764, Dec. 14, 2001]
§ 152.46 Notification and non-notification changes to registrations.
top
(a) Changes permitted by notification. (1) EPA may determine that certain minor modifications to
registration having no potential to cause unreasonable adverse effects to the environment may be
accomplished by notification to the Agency, without requiring that the registrant obtain Agency approval.
If EPA so determines, it will issue procedures following an opportunity for public comment describing the
types of modifications permitted by notification and any conditions and procedures for submitting
notifications.
(2) A registrant may modify a registration consistent with paragraph (a)(1) of this section and any
procedures issued thereunder and distribute or sell the modified product as soon as the Agency has
received the notification. Based upon the notification, the Agency may require that the registrant submit
an application for amended registration. If it does so, the Agency will notify the registrant and state its
reasons for requiring an application for amended registration. Thereafter, if the registrant fails to submit
an application the Agency may determine that the product is not in compliance with the requirements of
the Act. Notification under this paragraph is considered a report filed under the Act for the purposes of
FIFRA section 12(a)(2)(M).
(b) Changes permitted without notification. EPA may determine that certain minor modifications to
registration having no potential to cause unreasonable adverse effects to the environment may be
accomplished without notification to or approval by the Agency. If EPA so determines, it will issue
procedures following an opportunity for public comment describing the types of amendments permitted
without notification (also known as non-notification). A registrant may distribute or sell a product changed
in a manner consistent with such procedures without notification to or approval by the Agency.
(c) Effect of non-compliance. Notwithstanding any other provision of this section, if the Agency
determines that a product has been modified through notification or without notification in a manner
inconsistent with paragraphs (a) or (b) of this section and any procedures issued thereunder, the Agency
may initiate regulatory and/or enforcement action without first providing the registrant with an opportunity
to submit an application for amended registration.
[61 FR 33041, June 26, 1996]
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§ 152.50 Contents of application.
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Each application for registration or amended registration must include the following information, as
applicable:
(a) Application form. An application form must be completed and submitted to the Agency. Application
forms are provided by the Agency, with instructions as to the number of copies required and proper
completion.
(b) Identity of the applicant —(1) Name. The applicant must identify himself. An applicant not residing in
the United States must also designate an agent in accordance with paragraph (b)(3) of this section to act
on behalf of the applicant on all registration matters.
(2) Address of record. The applicant must provide an address in the United States for correspondence
purposes. The U.S. address provided will be considered the applicant's address of record, and EPA will
send all correspondence concerning the application and any subsequent registration to that address. It
is the responsibility of the applicant and any registrant under §152.122 to ensure that the Agency has a
current and accurate address.
(3) Authorized agent. An applicant may designate a person residing in the United States to act as his
agent. If an applicant wishes to designate an agent, he must send the Agency a letter stating the name
and United States address of his agent. The applicant must notify the Agency if he changes his
designated agent. This relationship may be terminated at any time by the applicant by notifying the
Agency in writing.
(4) Company number. If an applicant has been assigned a company number by the Agency, the
application must reference that number.
(c) Summary of the application . Each application must include a list of the data submitted with the
application, together with a brief description of the results of the studies. The list of data submitted may
be the same as the list required by §158.32 or §161.32, as applicable, of this chapter. The summary
must state that it is releasable to the public after registration in accordance with §152.119.
(d) Identity of the product. The product for which application is being submitted must be identified. The
following information is required:
(1) The product name;
(2) The trade name(s) (if different); and
(3) The EPA Registration Number, if currently registered.
(e) Draft labeling. Each application for new registration must be accompanied by five legible copies of
draft labeling (typescript or mock-up). Each application for amended registration that proposes to make
any changes in the product labeling must be accompanied by five legible copies of draft labeling
incorporating the proposed labeling changes. If the proposed labeling change affects only a portion of
the labeling, such as the use directions, the applicant may submit five copies of that portion of the label
which is the subject of the amendment. Upon request, an applicant for amended registration must
submit a complete label to consolidate amendments.
(f) Registration data requirements. (1) An applicant must submit materials to demonstrate that he has
complied with the FIFRA sec. 3(c)(1)(F) and subpart E of this part with respect to satisfaction of data
requirements, to enable the Agency to make the determination required by FIFRA sec. 3(c)(5)(B).
Required items are described in subpart E of this part.
(2) An applicant must furnish any data specified in part 158 or part 161 of this chapter, as applicable, of
this chapter which are required by the Agency to determine that the product meets the registration
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standards of FIFRA sec. 3(c)(5) or (7). Each study must comply with:
(i) Section 158.32 of this chapter, with respect to format of data submission.
(ii) Section 158.33 of this chapter, with respect to studies for which a claim of trade secret or confidential
business information is made.
(iii) Section 158.34 of this chapter, with respect to flagging for potential adverse effects.
(iv) Section 160.12 of this chapter, with respect to a statement whether studies were conducted in
accordance with Good Laboratory Practices of part 160.
(3) An applicant shall furnish with his application any factual information of which he is aware regarding
unreasonable adverse effects of the pesticide on man or the environment, which would be required to be
reported under FIFRA sec. 6(a)(2) if the product were registered.
(g) Certification relating to child-resistant packaging. If the product meets the criteria for child-resistant
packaging, the applicant must submit a certification that the product will be distributed or sold only in
child-resistant packaging. Refer to part 157 of this chapter for the criteria and certification requirements.
(h) Request for classification. If an applicant wishes to request a classification different from that
established by the Agency, he must submit a request for such classification and information supporting
the request.
(i) Statement concerning tolerances. If the proposed labeling bears instructions for use of the pesticide
on food or feed crops, or if the intended use of the pesticide results or may be expected to result, directly
or indirectly, in pesticide residues in or on food or feed (including residues of any active ingredient, inert
ingredient, metabolite, or degradation product), the applicant must submit a statement indicating whether
such residues are authorized by a tolerance, exemption from the requirement of a tolerance, or food
additive regulation issued under section 408 or 409 of the Federal Food, Drug and Cosmetic Act
(FFDCA). If such residues have not been authorized, the application must be accompanied by a petition
for establishment of appropriate tolerances, exemptions from the requirement of a tolerance, or food
additive regulations, in accordance with part 180 of this chapter.
[53 FR 15978, May 4, 1988, as amended at 58 FR 34203, June 23, 1993; 60 FR 32096, June 19, 1995;
72 FR 61027, Oct, 26 2007]
§ 152.55 Where to send applications and correspondence.
top
Applications and correspondence relating to registration should be sent to the Office of Pesticide
Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or
(b).
[71 FR 35545, June 21, 2006]
Subpart D [Reserved]
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Subpart E—Procedures To Ensure Protection of Data Submitters' Rights
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Source: 49 FR 30903, Aug. 1, 1984, unless otherwise noted.
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§ 152.80 General.
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This subpart E (§§152.80 through 152.119)1 describes the information that an applicant must submit
with his application for registration, amended registration, or reregistration to comply (and for the Agency
to determine compliance) with the provisions of FIFRA section 3(c)(1)(D). This subpart also describes
the procedures by which data submitters may challenge registration actions which allegedly failed to
comply with these procedures. If the Agency determines that an applicant has failed to comply with the
requirements and procedures in this subpart, the application may be denied. If the Agency determines,
after registration has been issued, that an applicant failed to comply with these procedures and
requirements, the Agency may issue a notice of intent to cancel the product's registration.
1
Editorial Note:Sections 152.116 and 152.119 were transferred to subpart F at 53 FR 15980,
May 4, 1988.
[49 FR 30903, Aug. 1, 1984, as amended at 58 FR 34203, June 23, 1993]
§ 152.81 Applicability.
top
(a) Except as provided in paragraph (b) of this section, §§152.83 through 152.119 apply to:
(1) Each application for registration of a new product;
(2) Each application for an amendment of a registration; and
(3) Each application for reregistration under FIFRA section 3(g).
(b) This subpart E does not apply to:
(1) Applications for registration submitted to States under FIFRA section 24(c);
(2) Applications for experimental use permits under FIFRA section 5;
(3) Applications for emergency exemptions under FIFRA section 18;
(4) Applications to make only one or more of the following types of amendments to existing registrations,
unless the Administrator or his designee finds that Agency consideration of scientific data would be
necessary in order to approve the amendment under FIFRA section 3(c)(5):
(i) An increase or decrease in the percentage in the product of one or more of its active ingredients or
deliberately added inert ingredients;
(ii) A revision of the identity or amount of impurities present in the product;
(iii) The addition or deletion of one or more deliberately added inert ingredients;
(iv) The deletion of one or more active ingredients;
(v) A change in the source of supply of one or more of the active ingredients used in the product, if the
new source of the active ingredient is a product which is registered under FIFRA section 3;
(vi) Deletion of approved uses of claims;
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(vii) Redesign of the label format involving no substantive changes, express or implied, in the directions
for use, claims, representations, or precautionary statements;
(viii) Change in the product name or addition of an additional brand name, if no additional claims,
representations, or uses are expressed or implied by the changes;
(ix) Clarification of directions for use;
(x) Correction of typographical errors;
(xi) Changes in the registrant's name or address;
(xii) Adding or deleting supplemental registrants;
(xiii) Changes in the package or container size;
(xiv) Changes in warranty, warranty disclaimer, or liability limitation statements, or addition to or deletion
of such statements;
(xv) “Splitting” a label for the sole purpose of facilitating the marketing of a product in different
geographic regions with appropriate labels, where each amended label will contain previously approved
use instructions (and related label statements) appropriate to a particular geographic region;
(xvi) Any other type of amendment, if the Administrator or his designee determines, by written finding,
that the Agency consideration of scientific data would not be necessary in order to approve the
amendment under FIFRA section 3(c)(5); and
(xvii) Compliance with Agency Regulations, adjudicatory hearing decisions, notices, or other Agency
announcements that unless the registration is amended in the manner the Agency proposes, the
product's registration will be suspended or cancelled, or that a hearing will be held under FIFRA section
6. (However, this paragraph does not apply to amendments designed to avoid cancellation or
suspension threatened under FIFRA section 3(c)(2)(B) or because of failure to submit data.)
§ 152.83 Definitions.
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As used in this subpart, the following terms shall have the meanings set forth in this section:
(a) Data gap means the absence of any valid study or studies in the Agency's files which would satisfy a
specific data requirement for a particular pesticide product.
(b) Data Submitters List means the current Agency list, entitled “Pesticide Data Submitters by Chemical,”
of persons who have submitted data to the Agency.
(c) Exclusive use study means a study that meets each of the following requirements:
(1) The study pertains to a new active ingredient (new chemical) or new combination of active
ingredients (new combination) first registered after September 30, 1978;
(2) The study was submitted in support of, or as a condition of approval of, the application resulting in
the first registration of a product containing such new chemical or new combination (first registration), or
an application to amend such registration to add a new use; and
(3) The study was not submitted to satisfy a data requirement imposed under FIFRA section 3(c)(2)(B);
Provided that, a study is an exclusive use study only during the 10-year period following the date of the
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first registration.
(d) Original data submitter means the person who possesses all rights to exclusive use or compensation
under FIFRA section 3(c)(1)(D) in a study originally submitted in support of an application for
registration, amended registration, reregistration, or experimental use permit, or to maintain an existing
registration in effect. The term includes the person who originally submitted the study, any person to
whom the rights under FIFRA section 3(c)(1)(D) have been transferred, or the authorized representative
of a group of joint data developers.
(e) Valid study means a study that has been conducted in accordance with the Good Laboratory
Practice standards of 40 CFR part 160 or generally accepted scientific methodology and that EPA has
not determined to be invalid.
§ 152.84 When materials must be submitted to the Agency.
top
All information required by this subpart should be submitted with the application, but may be submitted
at any later time prior to EPA's approval of the application. The Agency will not approve any application
until it determines either that the application is not subject to these requirements or that all required
materials have been submitted and are acceptable.
§ 152.85 Formulators' exemption.
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(a) Statutory provision . FIFRA section 3(c)(2)(D) excuses an applicant from the requirement to submit or
cite data pertaining to any pesticide contained in his product that is derived solely from one or more
EPA-registered products which the applicant purchases from another person. This provision is
commonly referred to as the formulators' exemption.
(b) Applicability of the formulators' exemption . (1) The formulators' exemption applies only to data
concerning the purchased product or its ingredients. These data may include, but are not limited to,
product chemistry, toxicology, residue chemistry, exposure, environmental fate, and ecological effects.
(2) The data to which the formulators' exemption applies usually will concern the safety of one or more
of the product's active ingredients, specifically, those active ingredients which are contained in the
purchased product. In general, data for which the required test substance is the technical grade of the
active ingredient, the pure active ingredient, the radiolabeled pure active ingredient, or a typical end-use
product are eligible for the formulators' exemption.
(3) The formulators' exemption generally does not apply to data on the applicant's product itself,
including the safety or efficacy of the product, unless the composition of the product is identical to the
purchased product. In general, data for which the required test substance is the product proposed for
registration are not eligible for the formulators' exemption.
(c) Limitation of the formulators' exemption . EPA interprets FIFRA section 3(c)(2)(D) as allowing an
applicant to use the formulators' exemption with respect to data concerning an ingredient of his product
only if:
(1) The application indicates that the ingredient's presence in the product is attributable solely to the
purchase from another person of an identified, registered product containing that ingredient and the use
of the purchased product in formulating the product; and
(2) The purchased product is a registered manufacturing-use product whose label does not prohibit its
use for making an end-use product labeled for any use for which the applicant's product will be labeled;
or
(3) The purchased product is a registered end-use product labeled for each use for which the applicant's
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product will be labeled.
(d) Claiming eligibility for the exemption . (1) If the product contains one or more ingredients eligible for
the formulators' exemption, the applicant need not comply with the requirements of §§152.90 through
152.96 with respect to any data requirement pertaining to such ingredient, provided that he submits to
the Agency a certification statement containing the following information (a form for this purpose is
available from the Agency):
(i) Identification of the applicant, and of the product by EPA registration number or file symbol.
(ii) Identification of each ingredient in the pesticide that is eligible for the formulators' exemption, and the
EPA registration number of the product that is the source of that ingredient.
(iii) A statement that the listed ingredients meet the requirements for the formulators' exemption.
(iv) A statement that the applicant has submitted (either previously or with the current application) a
complete, accurate and current Confidential Statement of Formula.
(v) The name, title and signature of the applicant or his authorized representative and the date of
signature.
(2) An applicant for amended registration is not required to submit a new formulators' exemption
statement, if the current statement in Agency files is complete and accurate.
(e) Approval of registration . Notwithstanding FIFRA section 3(c)(2)(D), EPA will not approve an
application unless there are available to EPA for its review all data that are necessary to make the
required risk/benefit finding under FIFRA section 3(c)(5) or section 3(c)(7).
[72 FR 61027, Oct. 26, 2007]
§ 152.86 The cite-all method.
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An applicant may comply with this subpart by citing all data in Agency files that are pertinent to its
consideration of the requested registration under FIFRA section 3(c)(5), in accordance with the
procedures in this section, as applicable.
(a) Exclusive use studies. The applicant must certify to the Agency that he has obtained, from each
person listed on the Data Submitters List as an exclusive use data submitter for the chemical in
question, a written authorization that contains at least the following information:
(1) Identification of the applicant to whom the authorization is granted;
(2) Authorization to the applicant to use all pertinent studies in satisfaction of data requirements for the
application in question; and
(3) The signature and title of the original data submitter or his authorized representative and date of the
authorization.
If the Agency identifies any exclusive use data submitter not on the Data Submitters List, the applicant
will be required prior to registration to obtain the necessary written authorization from such person.
(b) Other studies. The applicant must certify to the Agency that, with respect to each other person on the
Data Submitters List for the chemical in question:
(1) He has obtained from that person a written authorization that contains the information required by
paragraphs (a) (1) through (3) of this section; or
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(2) He has furnished to that person:
(i) A notification of his intent to apply for registration, including the name of the proposed product, and a
list of the product's active ingredients;
(ii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(D) for any
data on which the application relies;
(iii) An offer to commence negotiations to determine the amount and terms of compensation, if any, to be
paid for the use of any study; and
(iv) His name, address and telephone number.
(c) General offer to pay statement. The applicant must submit to the Agency the following general offer
to pay statement:
[ Name of applicant ] hereby offers and agrees to pay compensation to other persons, with
regard to the approval of this application, to the extent required by FIFRA section 3(c)(1)(D) of
the Federal Insecticide, Fungicide and Rodenticide Act.
(d) Acknowledgement of reliance on data. Each application filed under this section shall include an
acknowledgement that for purposes of FIFRA section 3(c)(1)(D) the application relies on the following
data:
(1) All data submitted with or specifically cited in the application; and
(2) Each other item of data in the Agency's files which:
(i) Concerns the properties or effects of the applicant's product, of any product which is identical or
substantially similar to the applicant's product, or of one or more of the active ingredients in the
applicant's product; and
(ii) Is one of the types of data that EPA would require to be submitted if the application sought the initial
registration under FIFRA section 3(c)(5) of a product with composition and intended uses identical or
substantially similar to the applicant's product, under the data requirements in effect on the date EPA
approves the applicant's present application.
§ 152.90 The selective method.
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An applicant may comply with this subpart by listing the specific data requirements that apply to his
product, its active ingredients, and use patterns, and demonstrating his compliance for each data
requirement by submitting or citing individual studies, or by demonstrating that no study has previously
been submitted to the Agency. This section summarizes the procedures that an applicant must follow if
he chooses the selective method of demonstrating compliance. Sections 152.91 through 152.96 contain
specific procedures for citing or submitting a study or demonstrating a data gap.
(a) List of data requirements. Each applicant must submit a list of the data requirements that would apply
to his pesticide, its active ingredients, and its use patterns, if the product were being proposed for
registration under FIFRA section 3(c)(5) for the first time. The applicant need not list data requirements
pertaining to any ingredient which qualifies for the formulator's exemption.
(1) If a Registration Standard has been issued for any active ingredient, the applicant must list the
applicable data requirements enumerated in that Standard for the active ingredient and, if end use
products are covered by the Registration Standard, for such products containing that active ingredient.
(2) If a Registration Standard has not been issued, or if an issued Registration Standard does not cover
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all data requirements for products containing the active ingredient in question, the applicant must list the
applicable requirements as prescribed by 40 CFR part 158 or part 161, as applicable. All required (R)
studies, and any studies that could be conditionally required (CR) based upon composition, use pattern,
or the results of required studies, are to be listed. The applicant may demonstrate via the data gap
procedures in §152.96 that a conditional requirement need not be satisfied by the submission or citation
of data at the time of application.
(b) Methods of demonstrating compliance. The applicant must state for each data requirement on the list
required by paragraph (a) of this section which of the following methods of compliance with the
requirement he is using, and shall provide the supporting documentation specified in the referenced
section.
(1) Existence of or granting of a data waiver. Refer to §152.91.
(2) Submission of a new valid study. Refer to §152.92.
(3) Citation of a specific valid study previously submitted to the Agency by the applicant or another
person, with any necessary written authorizations or offers to pay. Refer to §152.93.
(4) Citation of a public literature study. Refer to §152.94.
(5) Citation of all pertinent studies previously submitted to the Agency, with any necessary written
authorizations or offers to pay. Refer to §152.95.
(6) Documentation of a data gap. Refer to §152.96.
[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007]
§ 152.91 Waiver of a data requirement.
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The applicant may demonstrate compliance for a data requirement by documenting the existence of a
waiver in accordance with paragraph (a) of this section, or by being granted a new waiver requested in
accordance with paragraph (b) of this section.
(a) Request for extension of an existing waiver. An applicant may claim that a waiver previously granted
by the Agency also applies to a data requirement for his product. To document this claim, the applicant
must provide a reference to the Agency record that describes the previously granted waiver, such as an
Agency list of waivers or an applicable Registration Standard, and must explain why that waiver should
apply to his product.
(b) Request for a new waiver. An applicant who requests a waiver to satisfy a data requirement must
submit the information specified in 40 CFR 158.45 or 40 CFR 161.45.
(c) Effect of denial of waiver request. If the request for a new waiver or extension of an existing waiver is
denied by the Agency, the applicant must choose another method of satisfying the data requirement.
[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007]
§ 152.92 Submission of a new valid study.
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An applicant may demonstrate compliance for a data requirement by submitting a valid study that has
not previously been submitted to the Agency. A study previously submitted to the Agency should not be
resubmitted but should be cited in accordance with §152.93.
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§ 152.93 Citation of a previously submitted valid study.
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An applicant may demonstrate compliance for a data requirement by citing a valid study previously
submitted to the Agency. The study is not to be submitted to the Agency with the application.
(a) Study originally submitted by the applicant. If the applicant certifies that he is the original data
submitter, no documentation other than the citation is necessary.
(b) Study previously submitted by another person. If the applicant is not the original data submitter, the
applicant may cite the study only in accordance with paragraphs (b) (1) through (3) of this section.
(1) Citation with authorization of original data submitter. The applicant may cite any valid study for which
he has obtained the written authorization of the original data submitter. The applicant must obtain written
authorization to cite any study that is an exclusive use study. The applicant must certify that he has
obtained from the original data submitter a written authorization that contains at least the following
information:
(i) Identification of the applicant to whom the authorization is granted;
(ii) Identification by title, EPA Accession Number or Master Record Identification Number, and date of
submission, of the study or studies for which the authorization is granted;
(iii) Authorization to the applicant to use the specified study in satisfaction of the data requirement for the
application in question; and
(iv) The signature and title of the original data submitter or his authorized representative, and date of the
authorization.
(2) Citation with offer to pay compensation to the original data submitter. The applicant may cite any
valid study that is not subject to the exclusive use provisions of FIFRA section 3(c)(1)(D)(i) without
written authorization from the original data submitter if the applicant certifies to the Agency that he has
furnished to the original data submitter:
(i) A notification of the applicant's intent to apply for registration, including the proposed product name
and a list of the product's active ingredients;
(ii) Identification of the specific data requirement involved and of the study for which the offer to pay is
made (by title, EPA Accession Number or Master Record Identification Number, and date of submission,
if possible);
(iii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(D);
(iv) An offer to commence negotiations to determine the amount and terms of compensation, if any, to
be paid for the use of the study; and
(v) The applicant's name, address and telephone number.
(3) Citation without authorization or offer to pay. The applicant may cite any valid study without written
authorization from, or offer to pay to, the original data submitter, if:
(i) The study was originally submitted to the Agency on or before December 31, 1969; or
(ii) The study was originally submitted to the Agency on or before the date that is 15 years before the
date of the application for which it is cited, and the study is not an exclusive use study, as defined in
§152.83(c).
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§ 152.94 Citation of a public literature study or study generated at government
expense.
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(a) An applicant may demonstrate compliance for a data requirement by citing, and submitting to the
Agency, one of the following:
(1) A valid study from the public literature.
(2) A valid study generated by, or at the expense of, any government (Federal, State, or local) agency.
(b) In no circumstances does submission of a public literature study or government-generated study
confer any rights on the data submitter to exclusive use of data or compensation under FIFRA section 3
(c)(1)(D).
§ 152.95 Citation of all studies in the Agency's files pertinent to a specific data
requirement.
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An applicant normally may demonstrate compliance for a data requirement by citation of all studies in
the Agency's files pertinent of that data requirement. The applicant who selects this cite-all option must
submit to the Agency:
(a) A general offer to pay statement having the same wording as that specified in §152.86(c) except that
the offer to pay may be limited to apply only to data pertinent to the specific data requirement(s) for
which the cite-all method of support has been selected;
(b) A certification that:
(1) For each person who is included on the Data Submitters List as an original data submitter of
exclusive use data for the active ingredient in question, the applicant has obtained a written
authorization containing the information required by §152.86(a) for the use the any exclusive use study
that would be pertinent to the applicant's product; and
(2) For each person included on the current Data Submitters List as an original data submitter of data
that are not exclusive use for the active ingredient in question, the applicant has furnished:
(i) A notification of the applicant's intent to apply for registration, including the name of the proposed
product, and a list of the product's active ingredients;
(ii) Identification of the specific data requirement(s) for which the offer to pay for data is being made;
(iii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(D);
(iv) An offer to commence negotiations to determine the amount and terms of compensation, if any, to
be paid for use of any study; and
(v) The applicant's name, address and telephone number; and
(c) An acknowledgment having the same wording as that specified in §152.86(d), except that it may be
limited to apply only to data pertinent to the specific data requirement(s) for which the cite-all method of
support has been selected.
§ 152.96 Documentation of a data gap.
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top
Except as provided in paragraph (a) of this section, an applicant may defer his obligation to satisfy an
applicable data requirement until the Agency requests the data if he can demonstrate, by the procedure
in this section, that no other person has previously submitted to the Agency a study that would satisfy
the data requirement in question.
(a) When data gap procedures may not be used. (1) An applicant for registration of a product containing
a new chemical may not defer his obligation by the procedure in this section, unless he can demonstrate
to the Agency's satisfaction that the data requirement was imposed so recently that insufficient time has
elapsed for the study to have been completed and that, in the public interest, the product should be
registered during the limited period of time required to complete the study. Refer to FIFRA section 3(c)
(7)(C).
(2) An applicant for registration of a product under FIFRA section 3(c)(7) (A) or (B) may not defer his
obligation by the procedure in this section if the Agency requires the data to determine:
(i) Whether the product is identical or substantially similar to another currently registered product or
differs only in ways that would not substantially increase the risk of unreasonable adverse effects on the
environment;
(ii) If efficacy data are required, whether the product is efficacious; or
(iii) Whether the new use would substantially increase the risk of unreasonable adverse effects on the
environment, usually required when the application involves a new use of a product which is identical or
substantially similar to a currently registered product.
(b) Data gap listed in a Registration Standard. The applicant may rely on a data gap that is documented
by a Registration Standard without submitting the certification required by paragraph (c) of this section. If
the data gap listed in the Registration Standard has been filled since the issuance of the Standard, the
Agency will notify the applicant and require him to choose another method of demonstrating compliance.
(c) Certification of a data gap. Except as provided by paragraph (b) of this section, an applicant who
wishes to claim that a data gap exists must certify to the Agency that:
(1) The applicant has furnished, by certified mail, to each original data submitter on the current Data
Submitters List for the active ingredient in question, a notice containing the following information:
(i) The name and address of the applicant;
(ii) The name of the product, and a statement that the applicant intends to apply for registration of that
product;
(iii) The name(s) of the active ingredient(s) in the procuct;
(iv) A list of the data requirements for which the applicant intends to claim under this section that a data
gap exists; and
(v) A request that the data submitter identify, within 60 days of receipt of the notice, any valid study
which he has submitted to the Agency that would fulfill any of the data requirement(s) listed.
(2) The applicant has, within that 60-day period, received no response, or has received a negative
response, from each person notified; and
(3) The applicant has no basis to believe that any data have been submitted to the Agency that would
fulfill the data requirement, and is entitled to claim that a data gap exists.
(d) Requirement to obtain permission or make offer to pay. In responding to a data gap letter, the
original data submitter is not deemed to have given his authorization for the applicant to cite any study
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which the data submitter identifies in his response. The applicant must seek and obtain specific written
authorization from, or make an offer to pay to, the original data submitter to cite the identified study in
order to demonstrate compliance for the data requirement. Nothing, however, precludes the applicant
from requesting written authorization or making an offer to pay at the same time that he requests
confirmation of a data gap.
§ 152.97 Rights and obligations of data submitters.
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(a) Right to be listed on Data Submitters List. (1) Each original data submitter shall have the right to be
included on the Agency's Data Submitters List.
(2) Each original data submitter who wishes to have his name added to the current Data Submitters List
must submit to the Agency the following information:
(i) Name and current address;
(ii) Chemical name and common name (if any) of the active ingredient(s), with respect to which he is an
original data submitter;
(iii) For each such active ingredient, the type(s) of study he has previously submitted (corresponding to
Guidelines reference numbers given in tables in 40 CFR part 158 or part 161, as applicable), the date of
submission, and the EPA registration number, file symbol, or other identifying reference for which it was
submitted.
(3) Each applicant not already included on the Data Submitters List for a particular active ingredient
must inform the Agency at the time of submission of a relevant study whether he wishes to be included
on the Data Submitters List for that pesticide.
(b) Obligation to respond to data gap letters. An applicant who chooses to defer his obligation by
demonstrating the existence of a data gap must write to each original data submitter for confirmation that
the data submitter has not submitted a valid study that would satisfy the requirement. The original data
submitter is not required to respond to such letters. However, if he fails to respond, the applicant is
entitled to assume (and the Agency will act on the assumption) that the original data submitter has not
submitted a study to satisfy the requirement. The data submitter may thereby limit his right to later
challenge the applicant's claim if he fails respond in writing delivered to the applicant within 60 days of
receipt of the applicant's data gap letter.
[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007]
§ 152.98 Procedures for transfer of exclusive use or compensation rights to another
person.
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A person who possesses rights to exclusive use or compensation under FIFRA section 3(c)(1)(D) may
transfer such rights to another person in accordance with this section.
(a) The original data submitter must submit to the Agency a transfer document that contains the
following information:
(1) The name, address and state of incorporation (if any) of the original data submitter (the transferor);
(2) The name, address and state of incorporation (if any) of the person to whom the data rights are being
transferred (the transferee);
(3) Identification of each item of data transferred including:
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(i) The name of the study or item of data;
(ii) Whether the study is an exclusive use study, and, if so, when the period of exclusive use protection
expires;
(iii) The name of the person or laboratory that conducted the study;
(iv) The date the study was submitted to the Agency;
(v) The EPA document number assigned to the item of data (the Master Record Identification Number or
Accession Number), if known. If not known, the EPA administrative number (such as the EPA
Registration Number, petition number, file symbol, or permit number) with which the item of data was
submitted, such that the Agency can identify the item of data.
(vi) A statement that the transferor transfers irrevocably to the transferee all rights, titles, and interest in
the items of data named;
(vii) A statement that the transferor and transferee understand that any false statement may be
punishable under 18 U.S.C. 1001; and
(viii) The names, signatures and titles of the transferor and transferee, and the date signed.
(b) In addition, the original data submitter must submit to the Agency a notarized statement affirming
that:
(1) The person signing the transfer agreement is authorized by the original data submitter to bind the
data submitter;
(2) No court order prohibits the transfer, and any required court approvals have been obtained; and
(3) The transfer is authorized under Federal, State, and local law and relevant corporate charters,
bylaws or partnership agreements.
(c) The Agency will acknowledge the transfer of the data by notifying both transferor and transferee, and
will state the effective date of the transfer. Thereafter the transferee will be considered to be the original
data submitter of the items of data transferred for all purposes under FIFRA section 3(c)(1)(D), unless a
new transfer agreement is submitted to the Agency.
§ 152.99 Petitions to cancel registration.
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An original data submitter may petition the Agency to deny or cancel the registration of a product in
accordance with this section if he has submitted to the Agency a valid study which, he claims, satisfies a
data requirement that an applicant purportedly has failed to satisfy.
(a) Grounds for petition. (1) If an applicant has offered to pay compensation to an original data submitter
of a study (either specifically or by filing a general offer to pay statement), the original data submitter
may petition the Agency to deny or cancel the registration to which the offer related on any of the
following grounds:
(i) The applicant has failed to participate in an agreed-upon procedure for reaching an agreement on the
amount and terms of compensation. The petitioner shall submit a copy of the agreed-upon procedure
and describe the applicant's failure to participate in the procedure.
(ii) The applicant has failed to comply with the terms of an agreement on compensation. The petitioner
shall submit a copy of the agreement, and shall describe how the applicant has failed to comply with the
agreement.
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(iii) The applicant has failed to participate in an arbitration proceeding. The petitioner shall submit
evidence of such failure.
(iv) The applicant has failed to comply with the terms of an arbitration decision. The petitioner shall
submit a copy of the arbitration decision, and describe how the applicant has failed to comply with the
decision.
(2) When no offer to pay has been made, the petitioner shall state in his petition the basis for the
challenge, and describe how the failure of the applicant to comply with the procedures of this subpart
has deprived him of the rights accorded him under FIFRA section 3(c)(1)(D). Possible grounds for
challenge include, but are not limited to, the following:
(i) The applicant has failed to list a data requirement applicable to his product, or has failed to
demonstrate compliance with all applicable data requirements.
(ii) The applicant has submitted or cited a study that is not valid.
(iii) The applicant has submitted or cited a study that does not satisfy the data requirement for which it
was submitted or cited.
(iv) The applicant has failed to comply with the procedure for showing that a data gap exists.
(v) The applicant has improperly certified that a data gap exists. An original data submitter who has
failed without good cause to respond to an applicant's request for confirmation of a data gap may not
petition the Agency for review on this basis.
(vi) The applicant has submitted or cited a study originally submitted by the petitioner, without the
required authorization or offer to pay.
(b) Procedure for petition to the Agency —(1) Time for filing. A petition under paragraph (a)(1) of this
section may be filed at any time that the circumstances warrant. A petition under paragraph (a)(2) of this
section must be filed within one year after the Agency makes public the issuance of the registration.
(2) Notice to affected registrant. At the same time that the petitioner files his petition with the Agency, he
shall send a copy by certified mail to the affected applicant or registrant. The applicant or registrant shall
have 60 days from the date of his receipt of the petition to submit written comments to the Agency.
(c) Disposition of petitions. The Agency will consider the material submitted by the petitioner and the
response, if any, by the affected applicant or registrant.
(1) If the Agency determines that the petition is without merit, it will inform the petitioner and the affected
applicant or registrant that the petition is denied. Denial of a petition is a final Agency action.
(2) If the Agency determines that an applicant has acted in any way described by paragraph (a)(1) of this
section, the Agency will notify the petitioner and the affected applicant or registrant that it intends to deny
or cancel the registration of the product in support of which the data were cited. The affected applicant or
registrant will have 15 days from the date of delivery of this notice to respond. If the Agency determines,
after considering any response, that the affected applicant or registrant has acted in the ways described
by paragraph (a)(1) of this section, the Agency will deny or cancel the registration without further
hearing. Refer to FIFRA section 3(c)(1)(D)(ii). Denial or cancellation of a registration is a final Agency
action.
(3) Except as provided in paragraph (c)(2) of this section, if the Agency determines that an applicant for
registration of a product has acted in any way that deprives an original data submitter of rights under
FIFRA section 3(c)(1)(D), the Agency will take steps to deny the application or cancel the registration, as
appropriate. The procedures in FIFRA section 3(c)(6) or section 6(b) shall be followed. Denial or
cancellation is a final Agency action.
(d) Hearing. Any hearing will be conducted in accordance with the procedures in 40 CFR part 164. The
only matter for resolution at the hearing shall be whether the registrant failed to comply with the
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requirements and procedures of FIFRA section 3(c)(1)(D) or of this subpart, in the manner described by
the petitioner. A decision following a hearing shall be final.
Subpart F—Agency Review of Applications
top
Source: 53 FR 15980, May 4, 1988, unless otherwise noted.
§ 152.100 Scope.
top
(a) The Agency will follow the procedures in this subpart for all applications for registration, except an
application for registration of a pesticide that has been the subject of a previous Agency cancellation or
suspension notice under FIFRA sec. 6.
(b) The Agency will follow the procedures of subpart D of part 164 of this chapter in evaluating any
application for registration of a pesticide involving use of the pesticide in a manner that is prohibited by a
suspension or cancellation order, to the extent required by subpart D of part 164.
§ 152.102 Publication.
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The Agency will issue in theFederal Registera notice of receipt of each application for registration of a
product that contains a new active ingredient or that proposes a new use. After registration of the
product, the Agency will issue in theFederal Registera notice of issuance. The notice of issuance will
describe the new chemical or new use, summarize the Agency's regulatory conclusions, list missing
data and the conditions for their submission, and respond to comments received on the notice of
application.
§ 152.104 Completeness of applications.
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The applicant is responsible for the accuracy and completeness of all information submitted in
connection with the application. The Agency will review each application to determine whether it is
complete. An application is incomplete if any pertinent item specified in §152.50 has not been submitted,
or has been incorrectly submitted (for example, data required by part 158, or part 161 of this chapter, as
applicable, and not submitted in accordance with the requirements for format, claims of confidential
business information, or flagging).
[72 FR 61028, Oct. 26, 2007
§ 152.105 Incomplete applications.
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The Agency will not begin or continue the review of an application that is incomplete. If the Agency
determines that an application is incomplete or that further information is needed in order to complete
the Agency's review, the Agency will notify the applicant of the deficiencies and allow the applicant 75
days to make corrections or additions to complete the application. If the applicant believes that the
deficiencies cannot be corrected within 75 days, he must notify the Agency within those 75 days of the
date on which he expects to complete the application. If, after 75 days, the applicant has not responded,
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or if the applicant subsequently fails to complete the application within the time scheduled for
completion, the Agency will terminate any action on such application, and will treat the application as if it
had been withdrawn by the applicant. Any subsequent submission relating to the same product must be
submitted as a new application.
§ 152.107 Review of data.
top
(a) The Agency normally will review data submitted with an application that have not previously been
submitted to the Agency.
(b) The Agency normally will review other data submitted or cited by an applicant only:
(1) As part of the process of reregistering currently registered products;
(2) When acting on an application for registration of a product containing a new active ingredient;
(3) If such data have been flagged in accordance with §158.34 or 161.34 of this chapter; or
(4) When the Agency determines that it would otherwise serve the public interest.
(c) If the Agency finds that it needs additional data in order to determine whether the product may be
registered, it will notify the applicant as early as possible in the review process.
[53 FR 15980, May 4, 1988, as amended at 72 FR 61028, Oct. 26, 2007]
§ 152.108 Review of labeling.
top
The Agency will review all draft labeling submitted with the application. If an applicant for amended
registration submits only that portion of the labeling proposed for amendment, the Agency may review
the entire label, as revised by the proposed changes, in deciding whether to approve the amendment.
The Agency will not approve final printed labeling, but will selectively review it for compliance.
§ 152.110 Time for Agency review.
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The Agency will complete its review of applications as expeditiously as possible. Applications involving
new active ingredients, new uses, petitions for tolerance or exemptions, or consultation with other
Federal agencies normally will take longer than applications for substantially similar products and uses.
§ 152.111 Choice of standards for review of applications.
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The Agency has discretion to review applications under either the unconditional registration criteria of
FIFRA sec. 3(c)(5) or the conditional registration criteria of FIFRA sec. 3(c)(7). The type of review
chosen depends primarily on the extent to which the relevant data base has been reviewed for
completeness and scientific validity. EPA conducts data reviews needed to support unconditional
registrations on a chemical-by-chemical basis, according to an established priority list. Except for
applications for registration of a new active ingredient or in special cases where it finds immediate
review to be warranted, the Agency will not commence a complete review of the existing data base on a
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given chemical in response to receipt of an application for registration. Instead the Agency will review
the application using the criteria for conditional registration in FIFRA sec. 3(c)(7) (A) and (B).
§ 152.112 Approval of registration under FIFRA sec. 3(c)(5).
top
EPA will approve an application under the criteria of FIFRA sec. 3(c)(5) only if:
(a) The Agency has determined that the application is complete and is accompanied by all materials
required by the Act and this part, including, but not limited to, evidence of compliance with subpart E of
this part;
(b) The Agency has reviewed all relevant data in the possession of the Agency (see §§152.107 and
152.111);
(c) The Agency has determined that no additional data are necessary to make the determinations
required by FIFRA sec. 3(c)(5) with respect to the pesticide product which is the subject of the
application;
(d) The Agency has determined that the composition of the product is such as to warrant the proposed
efficacy claims for it, if efficacy data are required to be submitted by part 158 or part 161, as applicable,
of this chapter for the product.
(e) The Agency has determined that the product will perform its intended function without unreasonable
adverse effects on the environment, and that, when used in accordance with widespread and commonly
recognized practice, the product will not generally cause unreasonable adverse effects on the
environment;
(f) The Agency has determined that the product is not misbranded as that term is defined in FIFRA sec.
2(q) and part 156 of this chapter, and its labeling and packaging comply with the applicable
requirements of the Act, this part, and parts 156 and 157 of this chapter;
(g) If the proposed labeling bears directions for use on food, animal feed, or food or feed crops, or if the
intended use of the pesticide results or may reasonably be expected to result, directly or indirectly, in
pesticide residues (including residues of any active or inert ingredient of the product, or of any
metabolite or degradation product thereof) in or on food or animal feed, all necessary tolerances,
exemptions from the requirement of a tolerance, and food additive regulations have been issued under
FFDCA sec. 408, sec. 409 or both; and
(h) If the product, in addition to being a pesticide, is a drug within the meaning of FFDCA sec. 201(q),
the Agency has been notified by the Food and Drug Administration (FDA) that the product complies with
any requirements imposed by FDA.
[53 FR 15980, May 4, 1988, as amended at 72 FR 61028, Oct. 26, 2007]
§ 152.113 Approval of registration under FIFRA sec. 3(c)(7)—Products that do not
contain a new active ingredient.
top
(a) Except as provided in paragraph (b) of this section, the Agency may approve an application for
registration or amended registration of a pesticide product, each of whose active ingredients is contained
in one or more other registered peticide products, only if the Agency has determined that:
(1) It possesses all data necessary to make the determinations required by FIFRA sec. 3(c)(7)(A) or (B)
with respect to the pesticide product which is the subject of the application (including, at a minimum,
data needed to characterize any incremental risk that would result from approval of the application);
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(2) Approval of the application would not significantly increase the risk of any unreasonable adverse
effect on the environment; and
(3) The criteria of §152.112(a), (d), and (f) through (h) have been satisfied.
(b) Notwithstanding the provisions of paragraph (a) of this section, the Agency will not approve the
conditional registration of any pesticide under FIFRA sec. 3(c)(7)(A) unless the Agency has determined
that the applicant's product and its proposed use are identical or substantially similar to a currently
registered pesticide and use, or that the pesticide and its proposed use differ only in ways that would not
significantly increase the risk of unreasonable adverse effects on the environment.
(c) Notwithstanding the provisions of paragraph (a) of this section, the Agency will not approve the
conditional registration of any pesticide product for a new use under FIFRA sec. 3(c)(7)(B) if:
(1) The pesticide is the subject of a special review, based on a use of the product that results in human
dietary exposure; and
(2) The proposed new use involves use on a major food or feed crop, or involves use on a minor food or
feed crop for which there is available an effective alternative registered pesticide which does not meet
the risk criteria associated with human dietary exposure. The determination of available and effective
alternatives shall be made with the concurrence of the Secretary of Agriculture.
§ 152.114 Approval of registration under FIFRA sec. 3(c)(7)—Products that contain a
new active ingredient.
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An application for registration of a pesticide containing an active ingredient not in any currently
registered product may be conditionally approved for a period of time sufficient for the generation and
submission of certain of the data necessary for a finding of registrability under FIFRA sec. 3(c)(5) if the
Agency determines that:
(a) Insufficient time has elapsed since the imposition of the data requirement for those data to have been
developed;
(b) All other required test data and materials have been submitted to the Agency;
(c) The criteria in §152.112(a), (b), (d), and (f) through (h) have been satisfied;
(d) The use of the pesticide product during the period of the conditional registration will not cause any
unreasonable adverse effect on the environment; and
(e) The registration of the pesticide product and its subsequent use during the period of the conditional
registration are in the public interest.
§ 152.115 Conditions of registration.
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(a) Substantially similar products and new uses. Each registration issued under §152.113 shall be
conditioned upon the submission or citation by the registrant of all data which are required for
unconditional registration of his product under FIFRA sec. 3(c)(5), but which have not yet been
submitted, no later than the time such data are required to be submitted for similar pesticide products
already registered. If a notice requiring submission of such data has been issued under FIFRA sec. 3(c)
(2)(B) prior to the date of approval of the application, the applicant must submit or cite the data
described by that notice at the time specified by that notice. The applicant must agree to these
conditions before the application may be approved.
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(b) New active ingredients. Each registration issued under §152.114 shall be conditioned upon the
applicant's agreement to each of the following conditions:
(1) The applicant will submit remaining required data (and interim reports if required) in accordance with
a schedule approved by the Agency.
(2) The registration will expire upon a date established by the Agency, if the registrant fails to submit
data as required by the Agency. The expiration date will be established based upon the length of time
necessary to generate and submit the required data. If the studies are submitted in a timely manner, the
registration will be cancelled if the Agency determines, based on the data (alone, or in conjuction with
other data), that the product or one or more of its uses meets or exceeds any of the risk criteria
established by the Agency to initiate a special review. If the Agency so determines, it will issue to the
registrant a Notice of Intent to Cancel under FIFRA sec. 6(e), and will specify any provisions for sale and
distribution of existing stocks of the pesticide product.
(3) The applicant will submit an annual report of the production of the product.
(c) Other conditions. The Agency may establish, on a case-by-case basis, other conditions applicable to
registrations to be issued under FIFRA sec. 3(c)(7).
(d) Cancellation if condition is not satisfied. If any condition of the registration of the product is not
satisfied, or if the Agency determines that the registrant has failed to initiate or pursue appropriate action
towards fulfillment of any condition, the Agency will issue a notice of intent to cancel under FIFRA sec. 6
(e).
[53 FR 15980, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]
§ 152.116 Notice of intent to register to original submitters of exclusive use data.
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(a) Except as provided in paragraph (c) of this section, at least 30 days before registration of a product
containing an active ingredient for which a previously submitted study is eligible for exclusive use under
FIFRA sec. 3(c)(1)(D)(i), the Agency will notify the original submitter of the exclusive use study of the
intended registration of the product. If requested by the exclusive use data submitter within 30 days, the
Agency will also provide the applicant's list of data requirements and method of demonstrating
compliance with each data requirement.
(b) Within 30 days after receipt of the Agency's notice, or of the applicant's list of data requirements,
whichever is later, the exclusive use data submitter may challenge the issuance of the registration in
accordance with the procedures in §152.99 (b) and (c). If the Agency finds that the challenge has merit,
it will issue a notice of denial of the application. The applicant may then avail himself of the hearing
procedures provided by FIFRA sec. 3(c)(6). If the Agency finds that the challenge is without merit, it will
deny the petition and register the applicant's product. Denial of the petition is a final Agency action.
(c) If an applicant has submitted to the Agency a certification from an exclusive use data submitter that
he is aware of the applicant's application for registration, and does not object to the issuance of the
registration, the Agency will not provide the 30-day notification described in paragraph (a) of this section
to that exclusive use data submitter.
§ 152.117 Notification to applicant.
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The Agency will notify the applicant of the approval of his application by a Notice of Registration for new
registration, or by a letter in the case of an amended registration.
§ 152.118 Denial of application.
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top
(a) Basis for denial. The Agency may deny an application for registration if the Agency determines that
the pesticide product does not meet the criteria for registration under either FIFRA sec. 3(c)(5) or (7), as
specified in §§152.112 through 152.114.
(b) Notification of applicant. If the Agency determines that an application should be denied, it will notify
the applicant by certified letter. The letter will set forth the reasons and factual basis for the
determination with conditions, if any, which must be fulfilled in order for the registration to be approved.
(c) Opportunity for remedy by the applicant. The applicant will have 30 days from the date of receipt of
the certified letter to take the specified corrective action. During this time the applicant may request that
his application be withdrawn.
(d) Notice of denial. If the applicant fails to correct the deficiencies within the 30-day period, the Agency
may issue a notice of denial, which will be published in theFederal Register,and which will set forth the
reasons and the factual basis for the denial.
(e) Hearing rights. Within 30 days following the publication of the notice of denial, an applicant, or any
interested person with written authorization of the applicant, may request a hearing in accordance with
FIFRA sec. 6(b). Hearings will be conducted in accordance with part 164 of this chapter.
§ 152.119 Availability of material in support of registration.
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(a) The information submitted to support a registration application shall be part of the official Agency file
for that registration.
(b) Within 30 days after registration, the Agency will make available for public inspection, upon request,
the materials required by subpart E to be submitted with an application. Materials that will be publicly
available include an applicant's list of data requirements, the method used by the applicant to
demonstrate compliance for each data requirement, and the applicant's citations of specific studies in
the Agency's possession if applicable.
(c) Except as provided by FIFRA sec. 10, within 30 days after registration, the data on which the Agency
based its decision to register the product will be made available for public inspection, upon request, in
accordance with the procedures in 40 CFR part 2.
Subpart G—Obligations and Rights of Registrants
top
Source: 53 FR 15983, May 4, 1988, unless otherwise noted.
§ 152.122 Currency of address of record and authorized agent.
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(a) The registrant must keep the Agency informed of his current name and address of record. If the
Agency's good faith attempts to contact the registrant are not successful, the Agency will issue in
theFederal Registera notice of intent to cancel all products of the registrant under FIFRA sec. 6(b). The
registrant must respond within 30 days requesting that the registrations be maintained in effect, and
providing his name and address of record. If no response is received, the cancellations will become
effective at the end of 30 days without further notice to the registrant. The Agency may make provision
for the sale and distribution of existing stocks of such products after the effective date of cancellation.
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(b) The registrant must also notify the Agency if he changes his authorized agent.
§ 152.125 Submission of information pertaining to adverse effects.
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If at any time the registrant receives or becomes aware of any factual information regarding
unreasonable adverse effects of the pesticide on the environment that has not previously been
submitted to the Agency, he shall, in accordance with FIFRA sec. 6(a)(2), provide such information to
the Agency, clearly identified as FIFRA 6(a)(2) data.
[53 FR 15975, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]
§ 152.130 Distribution under approved labeling.
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(a) A registrant may distribute or sell a registered product with the composition, packaging and labeling
currently approved by the Agency.
(b) A registrant may distribute or sell a product under labeling bearing any subset of the approved
directions for use, provided that in limiting the uses listed on the label, no changes would be necessary
in precautionary statements, use classification, or packaging of the product.
(c) Normally, if the product labeling is amended on the initiative of the registrant, by submission of an
application for amended registration, the registrant may distribute or sell under the previously approved
labeling for a period of 18 months after approval of the revision, unless an order subsequently issued by
the Agency under FIFRA sec. 6 or 13 provides otherwise. However, if paragraph (d) of this section
applies to the registrant's product, the time frames established by the Agency in accordance with that
paragraph shall take precedence.
(d) If a product's labeling is required to be revised as a result of the issuance of a Registration Standard,
a Label Improvement Program notice, or a notice concluding a special review process, the Agency will
specify in the notice to the registrant the period of time that previously approved labeling may be used.
In all cases, supplemental or sticker labeling may be used as an interim compliance measure for a
reasonable period of time. The Agency may establish dates as follows governing when label changes
must appear on labels:
(1) The Agency may establish a date after which all product distributed or sold by the registrant must
bear revised labeling.
(2) The Agency may also establish a date after which no product may be distributed or sold by any
person unless it bears revised labeling. This date will provide sufficient time for product in channels of
trade to be distributed or sold to users or otherwise disposed of.
§ 152.132 Supplemental distribution.
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The registrant may distribute or sell his registered product under another person's name and address
instead of (or in addition to) his own. Such distribution and sale is termed “supplemental distribution” and
the product is referred to as a “distributor product.” The distributor is considered an agent of the
registrant for all intents and purposes under the Act, and both the registrant and the distributor may be
held liable for violations pertaining to the distributor product. Supplemental distribution is permitted upon
notification to the Agency if all the following conditions are met:
(a) The registrant has submitted to the Agency for each distributor product a statement signed by both
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the registrant and the distributor listing the names and addresses of the registrant and the distributor, the
distributor's company number, the additional brand name(s) to be used, and the registration number of
the registered product.
(b) The distributor product is produced, packaged and labeled in a registered establishment operated by
the same producer (or under contract in accordance with §152.30) who produces, packages, and labels
the registered product.
(c) The distributor product is not repackaged (remains in the producer's unopened container).
(d) The label of the distributor product is the same as that of the registered product, except that:
(1) The product name of the distributor product may be different (but may not be misleading);
(2) The name and address of the distributor may appear instead of that of the registrant;
(3) The registration number of the registered product must be followed by a dash, followed by the
distributor's company number (obtainable from the Agency upon request);
(4) The establishment number must be that of the final establishment at which the product was
produced; and
(5) Specific claims may be deleted, provided that no other changes are necessary.
(e) Voluntary cancellation of a product applies to the registered product and all distributor products
distributed or sold under that registration number. The registrant is responsible for ensuring that
distributors under his cancelled registration are notified and comply with the terms of the cancellation.
[53 FR 15975, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]
§ 152.135 Transfer of registration.
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(a) A registrant may transfer the registration of a product to another person, and the registered product
may be distributed and sold without the requirement of a new application for registration by that other
person, if the parties submit to the Agency the documents listed in paragraphs (b) and (c) of this section,
and receive Agency approval as described in paragraph (d) of this section.
(b) Persons seeking approval of a transfer of registration must provide a document signed by the
authorized representative of the registrant (the transferor) and of the person to whom the registration is
transferred (the transferee) that contains the following information:
(1) The name, address and State of incorporation (if any) of the transferor;
(2) The name, address and State of incorporation of the transferee;
(3) The name(s) and EPA registration number(s) of the product(s) being transferred;
(4) A statement that the transferor transfers irrevocably to the transferee all right, title, and interest in the
EPA registration(s) listed in the document;
(5) A statement that the transferred registration(s) shall not serve as collateral or otherwise secure any
loan or other payment arrangement or executory promise, and that the registration(s) shall not revert to
the transferor unless a new transfer agreement is submitted to and approved by the Agency;
(6) A description of the general nature of the underlying transaction, e.g., merger, spinoff, bankruptcy
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transfer (no financial information need be disclosed);
(7) A statement that the transferor and transferee understand that any false statement may be
punishable under 18 U.S.C. 1001; and
(8) An acknowledgment by the transferee that his rights and duties concerning the registration under
FIFRA and this chapter will be deemed by EPA to be the same as those of the transferor at the time the
transfer is approved.
(c) In addition, the transferor must submit to the Agency a notarized statement affirming that:
(1) The person signing the transfer agreement is authorized by the registrant to bind the transferor;
(2) No court order prohibits the transfer, and that any required court approvals have been obtained; and
(3) The transfer is authorized under all relevant Federal, State and local laws and all relevant corporate
charters, bylaws, partnerships, or other agreements.
(d) If the required documents are submitted, and no information available to the Agency indicates that
the information is incorrect, the Agency will approve the transfer without requiring that the transferee
obtain a new registration. The Agency will notify the transferor and transferee of its approval.
(e) The transfer will be effective on the date of Agency approval. Thereafter the transferee will be
regarded as the registrant for all purposes under FIFRA.
(f) Rights to exclusive use of data or compensation under FIFRA sec. 3(c)(1)(D) are separate from the
registration itself and may be retained by the transferor, or may be transferred independently in
accordance with the provisions of §152.98. If the registrant as the original data submitter wishes to
transfer data rights at the same time as he transfers the registration, he may submit a single transfer
document containing the information required by this section for both the registration and the data.
[53 FR 15983, May 4, 1988, as amended at 58 FR 34203, June 23, 1993]
Subpart H [Reserved]
top
Subpart I—Classification of Pesticides
top
Source: 53 FR 15986, May 4, 1988, unless otherwise noted.
§ 152.160 Scope.
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(a) Types of classification. A pesticide product may be unclassified, or it may be classified for restricted
use or for general use. The Agency does not normally classify products for general use; products that
are not restricted remain unclassified.
(b) Kinds of restrictions. The Agency may restrict a product or its uses to use by a certified applicator, or
by or under the direct supervision of a certified applicator, as described in FIFRA sec. 3(d)(1)(C). The
Agency may also, by regulation, prescribe restrictions relating to the product's composition, labeling,
packaging, uses, or distribution and sale, or to the status or qualifications of the user.
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§ 152.161 Definitions.
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In addition to the definitions in §152.3, the following terms are defined for the purposes of this subpart:
(a) Dietary LC 50means a statistically derived estimate of the concentration of a test substance in the
diet that would cause 50 percent mortality to the test population under specified conditions.
(b) Outdoor use means any pesticide application that occurs outside enclosed manmade structures or
the consequences of which extend beyond enclosed manmade structures, including, but not limited to,
pulp and paper mill water treatments and industrial cooling water treatments.
§ 152.164 Classification procedures.
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(a) Grouping of products for classification purposes. In its discretion, the Agency may identify a group of
products having common characteristics or uses and may classify for restricted use same or all of the
products or uses included in that group. Such a group may be comprised of, but is not limited to,
products that:
(1) Contain the same active ingredients.
(2) Contain the same active ingredients in a particular concentration range, formulation type, or
combination of concentration range and formulation type.
(3) Have uses in common.
(4) Have other characteristics, such as toxicity, flammability, or physical properties, in common.
(b) Classification reviews. The Agency may conduct classification reviews and classify products at any
time, if it determines that a restriction on the use of a pesticide product is necessary to avoid
unreasonable adverse effects on the environment. However, classification reviews normally will be
conducted and products classified only in the following circumstances:
(1) As part of the review of an application for new registration of a product containing an active
ingredient not contained in any currently registered product.
(2) As part of the review of an application for a new use of a product, if existing uses of that product
previously have been classified for restricted use. Review of a restricted use product at this time is for
the purpose of determining whether the new use should also be classified for restricted use. Normally
the Agency will not conduct initial classification reviews for existing uses of individual products in
conjunction with an application for amended registration.
(3) As part of the process of developing or amending a registration standard for a pesticide. The Agency
normally will conduct classification reviews of all uses of a currently registered pesticide at this time.
(4) As part of any special review of a pesticide, in accordance with the procedures of 40 CFR part 154.
(c) Classification procedures. (1) If the Agency determines that a product or one or more of its uses
should be classified for restricted use, the Agency initially may classify the product by regulation. In this
case, within 60 days after the effective date of a final rule, each registrant of a product subject to the rule
must submit to the Agency one of the following, as directed in the final rule:
(i) A copy of the amended label and any supplemental labeling to be used as an interim compliance
measure.
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(ii) A statement, which the Agency considers a report under the Act, that the registrant will comply with
the labeling requirements prescribed by the Agency within the timeframes prescribed by the regulation.
(iii) An application for amended registration to delete the uses which have been restricted, or to “split”
the registration into two registrations, one including only restricted or all uses, and the other including
only uses that have not been classified.
(2) Alternatively, EPA may notify the applicant or registrant of the classification decision and require that
he submit the information required by paragraph (c)(1) of this section. The Agency may deny registration
or initiate cancellation proceedings if the registrant fails to comply within the timeframes established by
the Agency in its notification.
§ 152.166 Labeling of restricted use products.
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(a) Products intended for end use. A product whose labeling bears directions for end use and that has
been classified for restricted use must be labeled in accordance with the requirements of §156.10 of this
chapter or other Agency instructions. The Agency will permit the use of stickers or supplemental labeling
as an interim alternative to the use of an approved amended label, in accordance with §152.167.
(b) Products intended only for formulation. A product whose labeling does not bear directions for end
use (a product that is intended and labeled solely for further formulation into other pesticide products) is
not subject to the labeling requirements of this subpart.
§ 152.167 Distribution and sale of restricted use products.
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Unless modified by the Agency, the compliance dates in this section shall apply to restricted use
products.
(a) Sale by registrant or producer. (1) No product with a use classified for restricted use may be
distributed or sold by the registrant or producer after the 120th day after the effective date of such
classification unless the product:
(i) Bears an approved amended label which contains the terms of restricted use imposed by the Agency
and otherwise complies with part 156 of this chapter;
(ii) Bears a sticker containing the product name, EPA registration number, and any terms of restricted
use imposed by the Agency; or
(iii) Is accompanied by supplemental labeling bearing the information listed in paragraph (a)(1)(ii) of this
section.
(2) If the registrant chooses to delete the restricted uses from his product label, that product may not be
distributed or sold after the 180th day after the effective date of classification unless the product bears
amended labeling with the restricted uses deleted.
(3) Notwithstanding paragraphs (a) (1) and (2) of this section, after the 270th day after the effective date
of classification, no registrant or producer may distribute or sell a product that does not bear the
approved amended label. After that date, stickers and supplemental labeling described in paragraph (a)
(1) (ii) and (iii) are no longer acceptable.
(b) Sale by retailer. No product with a use classified for restricted use by a regulation may be distributed
or sold by a retailer or other person after the 270th day after the effective date of the final rule unless the
product bears a label or labeling which complies with paragraph (a)(1) of this section.
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§ 152.168 Advertising of restricted use products.
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(a) Any product classified for restricted use shall not be advertised unless the advertisement contains a
statement of its restricted use classification.
(b) The requirement in paragraph (a) of this section applies to all advertisements of the product,
including, but not limited, to:
(1) Brochures, pamphlets, circulars and similar material offered to purchasers at the point of sale or by
direct mail.
(2) Newspapers, magazines, newsletters and other material in circulation or available to the public.
(3) Broadcast media such as radio and television.
(4) Telephone advertising.
(5) Billboards and posters.
(c) The requirement may be satisfied for printed material by inclusion of the statement “Restricted Use
Pesticide,” or the terms of restriction, prominently in the advertisement. The requirement may be
satisfied with respect to broadcast or telephone advertising by inclusion in the broadcast of the spoken
words “Restricted use pesticide,” or a statement of the terms of restriction.
(d) The requirements of this section shall be effective:
(1) After 270 days after the effective date of restriction of a product that is currently registered, unless
the Agency specifies a shorter time period;
(2) Upon the effective date of registration of a product not currently registered.
§ 152.170 Criteria for restriction to use by certified applicators.
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(a) General criteria. An end-use product will be restricted to use by certified applicators (or persons
under their direct supervision) if the Agency determines that:
(1) Its toxicity exceeds one or more of the specific hazard criteria in paragraph (b) or (c) of this section,
or evidence described in paragraph (d) of this section substantiates that the product or use poses a
serious hazard that may be mitigated by restricting its use;
(2) Its labeling, when considered according to the factors in paragraph (e)(2) of this section, is not
adequate to mitigate these hazard(s);
(3) Restriction of the product would decrease the risk of adverse effects; and
(4) The decrease in risks of the pesticide as a result of restriction would exceed the decrease in benefits.
(b) Criteria for human hazard —(1) Residential and institutional uses. A pesticide product intended for
residential or institutional use will be considered for restricted use classification if:
(i) The pesticide, as diluted for use, has an acute oral LD50of 1.5 g/kg or less;
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(ii) The pesticide, as formulated, has an acute dermal LD50of 2000 mg/kg or less;
(iii) The pesticide, as formulated, has an acute inhalation LC50of 0.5 mg/liter or less, based upon a 4hour exposure period;
(iv) The pesticide, as formulated, is corrosive to the eye (causes irreversible destruction of ocular tissue)
or results in corneal involvement or irritation persisting for more than 7 days;
(v) The pesticide, as formulated, is corrosive to the skin (causes tissue destruction into the dermis and/or
scarring) or causes severe irritation (severe erythema or edema) at 72 hours; or
(vi) When used in accordance with label directions, or widespread and commonly recognized practice,
the pesticide may cause significant subchronic, chronic or delayed toxic effects on man as a result of
single or multiple exposures to the product ingredients or residues.
(2) All other uses. A pesticide product intended for uses other than residential or institutional use will be
considered for restricted use classification if:
(i) The pesticide, as formulated, has an acute oral LD50of 50 mg/kg or less;
(ii) The pesticide, as formulated, has an acute dermal LD50of 200 mg/kg or less;
(iii) The pesticide, as diluted for use, has an acute dermal LD50of 16 g/kg or less;
(iv) The pesticide, as formulated, has an acute inhalation LC50of 0.05 mg/liter or less, based upon a 4hour exposure period;
(v) The pesticide, as formulated, is corrosive to the eye or causes corneal involvement or irritation
persisting for more than 21 days;
(vi) The pesticide, as formulated, is corrosive to the skin (causes tissue destruction into the dermis
and/or scarring); or
(vii) When used in accordance with label directions, or widespread and commonly recognized practice,
the pesticide may cause significant subchronic toxicity, chronic toxicity, or delayed toxic effects on man,
as a result of single or multiple exposures to the product ingredients or residues.
(c) Criteria for hazard to non-target species —(1) All products. A pesticide product intended for outdoor
use will be considered for restricted use classification if:
(i) When used according to label directions, application results in residues of the pesticide, its
metabolites, or its degradation products, in the diet of exposed mammalian wildlife, immediately after
application, such that:
(A) The level of such residues equals or exceeds one-fifth of the acute dietary LC50; or
(B) The amount of pesticide consumed in one feeding day (mg/kg/day) equals or exceeds one-fifth of the
mammalian acute oral LD50;
(ii) When used according to label directions, application results, immediately after application, in
residues of the pesticide, its metabolites or its degradation products, in the diet of exposed birds at
levels that equal or exceed one-fifth of the avian subacute dietary LC50;
(iii) When used according to label directions, application results in residues of the pesticide, its
metabolites or its degradation products, in water that equal or exceed one-tenth of the acute LC50for
non-target aquatic organisms likely to be exposed; or
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(iv) Under conditions of label use or widespread and commonly recognized practice, the pesticide may
cause discernible adverse effects on non-target organisms, such as significant mortality or effects on the
physiology, growth, population levels or reproduction rates of such organisms, resulting from direct or
indirect exposure to the pesticide, its metabolites or its degradation products.
(2) Granular products. In addition to the criteria of paragraph (c)(1) of this section, a pesticide intended
for outdoor use and formulated as a granular product will be considered for restricted use classification
if:
(i) The formulated product has an acute avian or mammalian oral LD50of 50 mg/kg or less as
determined by extrapolation from tests conducted with technical material or directly with the formulated
product; and
(ii) It is intended to be applied in such a manner that significant exposure to birds or mammals may
occur.
(d) Other evidence. The Agency may also consider evidence such as field studies, use history, accident
data, monitoring data, or other pertinent evidence in deciding whether the product or use may pose a
serious hazard to man or the environment that can reasonably be mitigated by restricted use
classification.
(e) Alternative labeling language. (1) If the Agency determines that a product meets one or more of the
criteria of paragraphs (b) or (c) of this section, or if other evidence identified in paragraph (d) of this
section leads the Agency to conclude that the product should be considered for restricted use
classification, the Agency will then determine if additional labeling language would be adequate to
mitigate the identified hazard(s) without restricted use classification. If the labeling language meets all
the criteria specified in paragraph (e)(2) of this section, the product will not be classified for restricted
use.
(2) The labeling will be judged adequate if it meets all the following criteria:
(i) The user, in order to follow label directions, would not be required to perform complex operations or
procedures requiring specialized training and/or experience.
(ii) The label directions do not call for specialized apparatus, protective equipment, or materials that
reasonably would not be available to the general public.
(iii) Failure to follow label directions in a minor way would result in few or no significant adverse effects.
(iv) Following directions for use would result in few or no significant adverse effects of a delayed or
indirect nature through bioaccumulation, persistence, or pesticide movement from the original
application site.
(v) Widespread and commonly recognized practices of use would not nullify or detract from label
directions such that unreasonable adverse effects on the environment might occur.
§ 152.171 Restrictions other than those relating to use by certified applicators.
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The Agency may by regulation impose restrictions on a product or class of products if it determines that:
(a) Without such restrictions, the product when used in accordance with warnings, cautions and
directions for use or in accordance with widespread and commonly recognized practices of use may
cause unreasonable adverse effects on the environment; and
(b) The decrease in risks as a result of restricted use would exceed the decrease in benefits as a result
of restricted use.
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§ 152.175 Pesticides classified for restricted use.
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The following uses of pesticide products containing the active ingredients specified below have been
classified for restricted use and are limited to use by or under the direct supervision of a certified
applicator.
Active
ingredient
Acrolein
Aldicarb
Aluminum
phosphide
Azinphos
methyl
Carbofuran
Chloropicrin
Formulation
As sole active
ingredient. No
mixtures
registered
As sole active
ingredient
No mixtures
registered
As sole active
ingredient. No
mixtures
registered
All liquids with a
concentration
greater than 13.5
pct
All other
formulations
All concentrate
suspensions and
wettable powders
40% and greater
All granular
formulations
All granular and
fertilizer
formulations
All formulations
greater than 2%
Criteria
influencing
Use pattern Classification1 restriction
All uses
Restricted
Inhalation
hazard to
humans.
Residue
effects on
avian
species and
aquatic
organisms.
Ornamental ......do
Other
uses (indoor
hazards—
and outdoor)
accident
history.
Agricultural Under further
crop uses
evaluation
......do
......do
Inhalation
hazard to
humans.
......do
......do
......do
Under futher
evaluation.
......do
......do
Rice
All uses
except rice
All uses
Do.
Acute
inhalation
toxicity.
Under
evaluation
......do
......do
Acute
inhalation
toxicity.
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Clonitralid
Dicrotophos
Disulfoton
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All formulations
Rodent
control
All formulations
2% and less
Outdoor uses Unclassified
(other than
rodent
control)
All uses
Restricted
All wettable
powders 70% and
greater
All granulars and Molluscide
wettable powders uses
Pressurized
Hospital
sprays 0.55% and antiseptics
less
All liquid
All uses
formulations 8%
and greater
All emulsifiable
concentrates 65%
and greater, all
emulsifiable
concentrates and
concentrate
solutions 21% and
greater with
fensulfothion 43%
and greater, all
emulsifiable
concentrates 32%
and greater in
combination with
32% fensulfothion
and greater
Non-aqueous
solution 95% and
greater
Granular
formulations 10%
and greater
......do
......do
Restricted
Hazard to
non-target
organisms.
Acute
inhalation
toxicity.
Effects on
aquatic
organisms.
Unclassified
Restricted
Restricted
Commercial Restricted
seed
treatment
Indoor uses ......do
(greenhouse)
Acute
dermal
toxicity;
residue
effects on
avian
species
(except for
tree
injections).
Do.
Acute
inhalation
toxicity.
Acute
dermal
toxicity.
Acute
inhalation
toxicity.
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Ethoprop
Emulsifiable
concentrates 40%
and greater
All granular and
fertilizer
formulations
Ethyl parathion All granular and
dust formulations
greater than 2 pct,
fertilizer
formulations,
wettable powders,
emulsifiable
concentrates,
concentrated
suspensions,
concentrated
solutions
Smoke fumigants
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Aquatic uses ......do
All uses
Under
evaluation
......do
Restricted
......do
......do
Dust and granular ......do
formulations 2 pct
and below
......do
Fenamiphos
Emulsifiable
......do
concentrates 35%
and greater
Fonofos
Emulsifiable
......do
concentrates 44%
and greater
Emulsifiable
Tobacco
concentrates
12.6% and less
with pebulate
50.3% and less
Methamidophos Liquid formulations ......do
40% and greater
Dust formulations ......do
2.5% and greater
......do
......do
Acute
dermal
toxicity.
Inhalation
hazard to
humans.
Acute
dermal
toxicity.
Residue
effects on
mammalian,
aquatic,
avian
species.
Inhalation
hazard to
humans.
Other
hazards—
accident
history.
Acute
dermal
toxicity.
Acute
dermal
toxicity.
Unclassified
Restricted
......do
Acute
dermal
toxicity;
residue
effects on
avian
species.
Residue
effects on
avian
species.
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Methidathion
Methomyl
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All formulations
All uses
except
nursery
stock,
safflower and
sunflower
All formulations
Nursery
stock,
safflower and
sunflower
As sole active
Nondomestic
ingredient in 1 pct outdoorsto 2.5 baits
agricultural
(except 1 pct fly
crops,
ornamental
bait)
and turf. All
other
registered
uses
All concentrated ......do
solution
formulations
90 pct wettable
powder
formulations (not
in water soluble
bags)
90 pct wettable
powder
formulation in
water soluble bags
All granular
formulations
25 pct wettable
powder
formulations
In 1.24 pct to 2.5
pct dusts as sole
active ingredient
and in mixtures
with fungicides
and chlorinated
hydrocarbon,
inorganic
phosphate and
biological
insecticides
......do
Do.
Unclassified
Restricted
Residue
effects on
mammalian
species.
......do
Other
hazardsaccident
history.
Do.
......do
......do
......do
Unclassified
......do
......do
......do
......do
......do
......do
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Methyl bromide All formulations in
containers greater
than 1.5 lb
Containers with
not more than 1.5
lb of methyl
bromide with 0.25
pct to 2.0 pct
chloropicrin as an
indicator
Container with not
more than 1.5 lb
having no
indicator
Methyl
All dust and
parathion
granular
formulations less
than 5 pct
Nicotine
(alkaloid)
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All uses
Restricted
Single
Unclassified
applications
(nondomestic
use) for soil
treatment in
closed
systems
All uses
Restricted
......do
......do
Microencapsulated ......do
......do
All dust and
......do
granular
formulations 5 pct
and greater and all
wettable powders
and liquids
......do
Liquid and dry
Indoor
......do
formulations 14% (greenhouse)
and above
All formulations
Applications ......do
to
cranberries
Liquid and dry
All uses
Unclassified
Do.
Do.
Other
hazardsaccident
history. All
foliar
applications
restricted
based on
residue
effects on
mammalian
and avian
species.
Residue
effects on
avian
species.
Hazard to
bees.
Acute
dermal
toxicity.
Residue
effects on
mammalian
and avian
species.
Acute
inhalation
toxicity.
Effects on
aquatic
organisms.
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formulations 1.5% (domestic
and less
and
nondomestic)
Paraquat
All formulations
All uses
Restricted
(dichloride) and and
paraquat bis
concentrations
(methyl sulfate) except those listed
below
Phorate
Pressurized spray Spot weed
formulations
and grass
containing 0.44
control
pct Paraquat bis
(methyl sulfate)
and 15 pct
petroleum
distillates as active
ingredients
Liquid fertilizers
All uses
containing
concentrations of
0.025 pct paraquat
dichloride and
0.03 percent
atrazine; 0.03 pct
paraquat
dichloride and
0.37 pct atrazine,
0.04 pct paraquat
dichloride and
0.49 pct atrazine
Liquid formulations ......do
65% and greater
Other
hazards.
Use and
accident
history,
human
toxicological
data.
......do
Unclassified
Restricted
Acute
dermal
toxicity.
Residue
effects on
avian
species
(applies to
foliar
applications
only).
Residue
effects on
mammalian
species
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All granular
formulations
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Rice
......do
Phosphamidon Liquid formulations ......do
75% and greater
......do
Dust formulations ......do
1.5% and greater
......do
All formulations
......do
and
concentrations
except tordon 101
R
......do
Control of
unwanted
trees by cut
surface
treatment
All uses
Unclassified
Sodium
cyanide3
Tordon 101 R
forestry herbicide
containing 5.4 pct
picloram and 20.9
pct 2.4–D
All capsules and
ball formulations
Restricted
Sodium
fluoroacetate
All solutions and
dry baits
......do
......do
Strychnine
All dry baits,
......do
......do
Picloram
(applies to
foliar
application
only).
Effects on
aquatic
organisms.
Acute
dermal
toxicity.
Residue
effects on
mammalian
species.
Residue
effects on
avian
species.
Do.
Residue
effects on
mammalian
species.
Hazard to
nontarget
organisms
(specifically
nontarget
plants both
crop and
noncrop).
Inhalation
hazard to
humans.
Acute oral
toxicity.
Hazard to
nontarget
organisms.
Use and
accident
history.
Acute oral
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pellets and
powder
formulations
greater than 0.5
pct
All dry baits,
pellets and
powder
formulations
All dry baits,
pellets and
powder
formulations 0.5
pct and below
......do
Sulfotepp
All subsoil
uses
Sprays and smoke All uses
generators
Zinc Phosphide All formulations
2% and less
All uses
All uses
calling for
burrow
builders
All uses
except
subsoil
......do
......do
toxicity.
Hazard to
nontarget
avain
species.
Use and
accident
history.
Hazard to
nontarget
organisms.
Do.
Unclassified
Restricted
Inhalation
hazard to
humans.
All domestic Unclassified
uses and
non-domestic
uses in and
around
buildings
All dry
formulations 60%
and greater.
Restricted
Acute
inhalation
toxicity.
All bait
Non......do
formulations
domestic
outdoor uses
(other than
around
buildings)
All dry
Domestic
......do
formulations 10% uses
and greater
Hazard to
non-target
organisms.
Acute oral
toxicity.
1“Under
evaluation” means no classification decision has been made and the use/formulation in
question is still under active review within EPA.
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2Percentages
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given are the total of dioxathion plus related compounds.
3(Note—M–44
sodium cyanide capsules may only be used by certified applicators who have also taken
the required additional training.)
[43 FR 5790, Feb. 9, 1978, as amended at 44 FR 45132, Aug. 1, 1979; 46 FR 5698, Jan. 19, 1981.
Redesignated and amended at 53 FR 15988, May 4, 1988; 60 FR 32096, June 19, 1995]
Subparts J–T [Reserved]
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Subpart U—Registration Fees
top
Source: 53 FR 19114, May 26, 1988, unless otherwise noted.
§ 152.400 Purpose.
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Subpart U prescribes fees to be charged for the pesticide regulatory activities set forth in §152.403 as
performed by the Environmental Protection Agency (as authorized by 31 U.S.C. 9701 and Pub. L. 100–
202) and provisions regarding their payment.
§ 152.401 Inapplicability of fee provisions to applications filed prior to October 1,
1997.
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No fee required by this subpart U shall be levied with respect to any application filed during the period
beginning on October 25, 1988, and ending on September 30, 1997. See FIFRA section 4(i)(7) (added
to FIFRA by Pub. L. 100–532, October 25, 1988, 102 Stat. 2654).
[53 FR 11923, Mar. 22, 1989]
§ 152.403 Definitions of fee categories.
top
(a) New chemical registration review means review of an application for registration of a pesticide
product containing a chemical active ingredient which is not contained as an active ingredient in any
other pesticide product that is registered under FIFRA at the time the application is made.
(b) New biochemical and microbial registration review means review of an application for registration of
a biochemical or microbial pesticide product containing a biochemical or microbial active ingredient not
contained in any other pesticide product that is registered under FIFRA at the time the application is
made. For purposes of this subpart, the definitions of biochemical and microbial pesticides contained in
§158.2000 and §158.2100, respectively, shall apply.
(c) New use pattern registration review means review of an application for registration, or for amendment
of a registration entailing a major change to the use pattern of an active ingredient contained in a
product registered under FIFRA or pending Agency decision on a prior application at the time of
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application. For purposes of this paragraph, examples of major changes include but are not limited to,
changes from non-food to food use, outdoor to indoor use, ground to aerial application, terrestrial to
aquatic use, and non-residential to residential use.
(d) Old chemical registration review means review of an application for registration of a new product
containing active ingredients and uses which are substantially similar or identical to those currently
registered or for which an application is pending Agency decision.
(e) Amendment review means review of any application requiring Agency approval to amend the
registration of a currently registered product, or for which an application is pending Agency decision, not
entailing a major change to the use pattern of an active ingredient.
(f) Experimental use permit review means review of an application for a permit pursuant to section 5 of
FIFRA to apply a limited quantity of a pesticide in order to accumulate information necessary to register
the pesticide. The application may be for a new chemical or for a new use of an old chemical. The fee
applies to such experimental uses of a single unregistered active ingredient (no limit on the number of
other active ingredients, in a tank mix, already registered for the crops involved) and no more than three
crops. This fee does not apply to experimental use permits required for small-scale field testing of
microbial pest control agents (40 CFR 172.3).
[53 FR 19114, May 26, 1988, as amended at 72 FR 61028, Oct. 26, 2007]
§ 152.404 Fee amounts.
top
The fee prescribed by the following table must be submitted with each application for registration,
amended registration or experimental use permit. Fees will be adjusted annually in accordance with
§152.410. The Agency may waive or refund fees in accordance with §152.412.
Table—Registration Fees
Type of review
New chemical
New biochemical or microbial
New use pattern
Experimental use permit
Old chemical
Amendment
Fee
$184,500
64,000
33,800
4,500
4,000
700
[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]
§ 152.406 Submission of supplementary data.
top
Applicants may submit data to supplement pending applications without incurring additional charges if
the proper fee was paid with submission of the original application and subsequent submissions of
supplementary data do not constitute a change in the type of registration action requested.
[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]
§ 152.408 Special considerations.
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top
(a) If two or more applicants apply for a new chemical registration for products having the same active
ingredient and each applicant provides a set of data in support of the registration developed
independently of the other applicants' data, then each applicant submitting an independent set of data
shall be charged the full new chemical registration review fee.
(b) If two or more applicants apply for a new chemical registration for products having the same active
ingredient and the applicants have jointly developed or paid for the joint development of a common set
of data to support their applications for registration, then each applicant shall be charged an equal share
of the total fee for review of the applications for all of the subject products. The total fee will include the
sum of the new chemical registration review fee for one product and one old chemical registration review
fee for each additional product.
(c) If an application is received for registration of a product that contains two or more new chemical
active ingredients and a different set of generic data is required by the Agency for each new chemical for
the purpose of registration, the applicant will be required to pay the full new chemical registration review
fee for each active ingredient.
§ 152.410 Adjustment of fees.
top
(a) The fee schedule will be adjusted annually by the same percentage as the percent change in the
Federal General Schedule (GS) pay scale. Such adjustments will be published in theFederal Registeras
a final rule and will be effective 30 days or more after promulgation.
(b) Processing costs and fees will be reviewed periodically and changes will be made to the schedule as
necessary. Such adjustments will be published for notice and comment in theFederal Register.
§ 152.412 Waivers and refunds.
top
(a) Refunds. If an application is not accepted for processing because it is incomplete, the fee, less
$1,200 for handling and initial review (or the amount of the fee, whichever is less), shall be returned. If
an application is withdrawn by the applicant before significant Agency scientific review has begun, the
fee, less $1,200, shall be returned. If an unacceptable or withdrawn petition is resubmitted, it shall be
accompanied by the fee that would be required if it were submitted for the first time.
(b) Waiver of fees for activities initiated by the Agency. The Agency may waive fees for amended
registrations where the amendment has been initiated solely by the Agency. The Agency retains sole
discretion in determining when this fee will be waived. The announcement of the fee waiver will
accompany the EPA request for an amendment. The Agency will not approve any individual requests for
waivers of EPA-initiated activity fees.
(c) Waiver of fees for activities initiated by applicants. Upon request by an applicant, together with the
supporting documentation or justification described in this paragraph, the Agency may waive or refund
fees in whole or in part. A request for waiver must be submitted in accordance with §152.414(a). An
application for which a waiver of fees has been requested will not be accepted for review until the waiver
has been granted, or until the waiver has been denied and thereafter the proper fee has been submitted.
(1) Minor use. Fees may be waived for applications limited to minor uses that lack commercial feasibility
for the pesticide applicant. An applicant requesting a waiver on this basis must provide supporting
information that demonstrates that anticipated revenues from the uses that are the subject of the
application would be insufficient to pay back the cost of the fee. The burden of proof of the
reasonableness of this estimate rests with the applicant.
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(2) IR–4. Fees will be waived for registration actions that are determined to be specifically associated
with tolerance petitions submitted by the Inter-Regional Research Project Number 4 (IR–4 program)
when such waiver is deemed by the Agency to be in the public interest.
(3) Severe economic impact. The Agency may waive two-thirds of any cumulative registration fee
payment in a 12-month period following completion of the applicant's most recent fiscal year that
exceeds 3 percent of the applicant's pesticide sales in its most recently completed fiscal year. An
applicant requesting a waiver on this basis must provide documentation (e.g. copy of an annual report,
or income tax forms filed with the Internal Revenue Service, or if needed, a notarized statement signed
by a corporate officer regarding annual pesticide sales) demonstrating that:
(i) The company applying had less than $40 million in gross revenue (including all revenue sources) in
the most recently concluded fiscal year of operation, and a single fee would constitute more than 3
percent of the applicant's gross revenue from pesticide sales in the most recently completed fiscal year
of operation, or
(ii) The company applying had less than $40 million in gross revenue (including all revenue sources) in
the most recently concluded fiscal year of operation, and the cumulative registration fees paid during the
12 months following the applicant's most recently completed fiscal year, including any registration fees
paid for the applicant for which a waiver is requested, constitute more than 3 percent of the applicant's
gross revenue from pesticide sales in the most recently concluded fiscal year of operation.
(iii) The Agency will not grant such a waiver if it determines that the entity submitting the application has
been formed or manipulated to qualify for such a waiver.
(4) Public interest. The Agency, in its discretion, may waive in whole or in part any of the fees
established herein in the public interest. Examples include, but are not limited to, pesticides offering
unique advantages for reducing public health risks, those that significantly reduce a current
environmental risk, or a product with extraordinary utility for use in Integrated Pest Management (IPM).
[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]
§ 152.414 Procedures.
top
(a) Procedures for requesting a waiver. (1) A request for a waiver must be submitted in writing at the
time the application is submitted to the Office of Pesticide Programs' Document Processing Desk at the
appropriate address as set forth in 40 CFR 150.17(a) or (b).
(2) A payment of $1,200 for processing the waiver or the amount of the actual fee, whichever is less,
must be submitted simultaneously to the address set forth in paragraph (b) of this section. This fee will
be refunded (or applied to any resulting partial fee) if the waiver is granted. Payment of fees for the
registration activities, in contrast to the waiver fee, shall not be required until the Agency makes a
determination on the waiver request. Since the actual fee is submitted to an address different than the
one to which the waiver request is submitted, a copy of the payment document must be submitted with
the waiver request that is submitted to the Office of Pesticide Programs' Document Processing Desk as
described in paragraph (a)(1) of this section. No fee is required from a person who has no financial
interest in the application.
(b) Procedures for payment of fees. All fees required by this section must be paid by money order, bank
draft, or certified check drawn to the order of the Environmental Protection Agency. All payment of fees
must be forwarded to the Environmental Protection Agency, Headquarters Accounting Operations
Branch, Office of Pesticide Programs (Registration Fees), P.O. Box 360277M, Pittsburgh, PA 15251.
The payments should be specifically labeled “Registration Fees” and should be accompanied only by a
copy of the registration application form or the experimental use permit application form, as appropriate.
An application will not be accepted for processing until the required fees have been submitted.
(c) Procedures for submitting application and supporting data. The application, along with supporting
data, shall be forwarded within 30 days of payment to the Washington DC address set forth in paragraph
(a)(1) of this section.
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[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993; 69 FR 39864, July 1, 2004;
71 FR 35545, June 21, 2006]
Subparts V–Y [Reserved]
top
Subpart Z—Devices
top
§ 152.500 Requirements for devices.
top
(a) A device is defined as any instrument or contrivance (other than a firearm) intended for trapping,
destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and
other than a bacterium, virus, or other microorganism on or in living man or living animals) but not
including equipment used for the application of pesticides (such as tamper-resistant bait boxes for
rodenticides) when sold separately therefrom.
(b) A device is not required to be registered under FIFRA sec. 3. The Agency has issued a policy
statement concerning its authority and activities with respect to devices, which was published in
theFederal Registerof November 19, 1976 (41 FR 51065). A device is subject to the requirements set
forth in:
(1) FIFRA sec. 2(q)(1) and part 156 of this chapter, with respect to labeling;
(2) FIFRA sec. 7 and part 167 of this chapter, with respect to establishment registration and reporting;
(3) FIFRA sec. 8 and part 169 of this chapter, with respect to books and records;
(4) FIFRA sec. 9, with respect to inspection of establishments;
(5) FIFRA sec. 12, 13, and 14, with respect to violations, enforcement activities, and penalties;
(6) FIFRA sec. 17, with respect to import and export of devices;
(7) FIFRA sec. 25(c)(3), with respect to child-resistant packaging; and
(8) FIFRA sec. 25(c)(4), with respect to the Agency's authority to declare devices subject to certain
provisions of the Act.
[53 FR 15990, May 4, 1988. Redesignated at 60 FR 32096, June 19, 1995]
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Section 508 / Accessibility
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=224da6e96e6083e1054a791a76a... 10/16/2008
| File Type | application/pdf |
| File Title | Microsoft Word - Attachment D.doc |
| Author | Caroline |
| File Modified | 2008-10-17 |
| File Created | 2008-10-14 |