5 

SUBCHAPTER E—PESTICIDE PROGRAMS 

PART 150—GENERAL 

AUTHORITY: Reorganization Plan No. 3 of 

1970 (5 U.S.C. App.). 

§ 150.17 Addresses for applications and 

correspondence. 

The official addresses for all submissions directed to the Office of Pesticide 

Programs (OPP) of the Environmental 

Protection Agency are as follows: 

(a) United States Postal Service mailing 

address. Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington 

DC 20460–0001. 

(b) Hand/courier delivery address. Office of Pesticide Programs, Environmental Protection Agency, 2777 S. 

Crystal Dr., Arlington, VA 22202–4501. 

(c) OPP Regulatory Public Docket address. OPP Regulatory Public Docket is 

physically located in Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA 22202–4501. 

This is not a mailing address. 

[71 FR 35545, June 21, 2006] 

PART 151 [RESERVED] 

PART 152—PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES 

Subpart A—General Provisions 

Sec. 

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 intended for a pesticidal purpose. 

152.15 Pesticide products required to be registered. 

Subpart B—Exemptions 

152.20 Exemptions for pesticides adequately 

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 Who may apply. 

152.42 Application for new registration. 

152.43 Alternate formulations. 

152.44 Application for amended registration. 

152.46 Notification and non-notification 

changes to registrations. 

152.50 Contents of application. 

152.55 Where to send applications and correspondence. 

Subpart D [Reserved] 

Subpart E—Procedures To Ensure 

Protection of Data Submitters’ Rights 

152.80 General. 

152.81 Applicability. 

152.83 Definitions. 

152.84 When materials must be submitted to 

the Agency. 

152.85 Formulators’ exemption. 

152.86 The cite-all method. 

152.90 The selective method. 

152.91 Waiver of a data requirement. 

152.92 Submission of a new valid study. 

152.93 Citation of a previously submitted 

valid study. 

152.94 Citation of a public literature study 

or study generated at government expense. 

152.95 Citation of all studies in the Agency’s 

files pertinent to a specific data requirement. 

152.96 Documentation of a data gap. 

152.97 Rights and obligations of data submitters. 

152.98 Procedures for transfer of exclusive 

use or compensation rights to another 

person. 

152.99 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. 


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§ 152.1 40 CFR Ch. I (7–1–11 Edition) 

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 submitted 

in support of registration. 

Subpart G—Obligations and Rights of 

Registrants 

152.122 Currency of address of record and 

authorized agent. 

152.125 Submission of information pertaining to adverse effects. 

152.130 Distribution under approved labeling. 

152.132 Supplemental distribution. 

152.135 Transfer of registration. 

Subpart H [Reserved] 

Subpart I—Classification of Pesticides 

152.160 Scope. 

152.161 Definitions. 

152.164 Classification procedures. 

152.166 Labeling of restricted use products. 

152.167 Distribution and sale of restricted 

use products. 

152.168 Advertising of restricted use products. 

152.170 Criteria for restriction to use by certified applicators. 

152.171 Restrictions other than those relating to use by certified applicators. 

152.175 Pesticides classified for restricted 

use. 

Subparts J–T [Reserved] 

Subpart U—Registration Fees 

152.400 Purpose. 

152.401 Inapplicability of fee provisions to 

applications filed prior to October 1, 1997. 

152.403 Definitions of fee categories. 

152.404 Fee amounts. 

152.406 Submission of supplementary data. 

152.408 Special considerations. 

152.410 Adjustment of fees. 

152.412 Waivers and refunds. 

152.414 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 

SOURCE: 53 FR 15975, May 4, 1988, unless 

otherwise noted. 

§ 152.1 Scope. 

(a) Part 152 sets forth procedures, requirements and criteria concerning the 

registration of pesticide products under 

FIFRA section 3, including plant-incorporated protectants (PIPs). Unless specifically superseded by part 174, the 

regulations in part 152 apply to PIPs. 

(b) Part 152 also describes associated 

regulatory activities affecting registration, as described in this paragraph. 

(1) Data compensation and exclusive 

use of data in support of registration. 

Refer to subpart E of this part. 

(2) Rights and obligations of registrants. 

Refer to subpart G of this part. 

(3) Classification of pesticide uses. 

Refer to subpart I of this part. 

(4) Fees. Refer to subpart U of this 

part. 

(5) Requirements pertaining to pesticide 

devices. Refer to subpart Z of this part. 

[73 FR 75594, Dec. 12, 2008] 

§ 152.3 Definitions. 

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. 

Acute dermal LD50 means 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 LC50 means 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 LD50 means a statistically 

derived estimate of the single oral dose 


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Environmental Protection Agency § 152.3 

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 or amended registration 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. 

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. 

(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 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. 

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. 


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§ 152.5 40 CFR Ch. I (7–1–11 Edition) 

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. 

Released for shipment. A product becomes released for shipment when the 

producer has packaged and labeled it in 

the manner in which it will be distributed or sold, or has stored it in an area 

where finished products are ordinarily 

held for shipment. Products stored in 

an area where finished products are ordinarily held for shipment, but which 

are not intended to be released for 

shipment must be physically separated 

and marked as not yet released for 

shipment. Once a product becomes released for shipment, the product remains in the condition of being released for shipment unless subsequent 

activities, such as relabeling or repackaging, constitute production. 

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; 73 FR 64224, Oct. 29, 

2008; 73 FR 75594, Dec. 12, 2008] 

§ 152.5 Pests. 

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. 

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. 


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Environmental Protection Agency § 152.6 

(2) Claims. The product must bear a 

sterilant claim, or a sterilant plus subordinate level disinfection claim. Products that bear antimicrobial claims 

solely at a level less than ‘‘sterilant’’ 

are not excluded and are jointly regulated by EPA and FDA. 

(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. 

(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 


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§ 152.8 40 CFR Ch. I (7–1–11 Edition) 

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, as amended at 73 

FR 75594, Dec. 12, 2008] 

§ 152.8 Products that are not pesticides because they are not for use 

against pests. 

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 intended for a pesticidal purpose. 

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. 

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): 


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Environmental Protection Agency § 152.25 

(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 

SOURCE: 53 FR 15977, May 4, 1988, unless 

otherwise noted. 

§ 152.20 Exemptions for pesticides adequately regulated by another Federal agency. 

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. 

(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. 

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 


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§ 152.25 40 CFR Ch. I (7–1–11 Edition) 

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 

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 

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 


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Environmental Protection Agency § 152.30 

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). 

[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. 

An unregistered pesticide, or a pesticide whose registration has been cancelled or suspended, may be distributed 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. 


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§ 152.40 40 CFR Ch. I (7–1–11 Edition) 

Subpart C—Registration 

Procedures 

SOURCE: 53 FR 15978, May 4, 1988, unless 

otherwise noted. 

§ 152.40 Who may apply. 

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. 

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. 

(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. 

(a) Except as provided by §152.46, any 

modification in the composition, labeling, or packaging of a 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] 


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Environmental Protection Agency § 152.50 

§ 152.46 Notification and non-notification changes to registrations. 

(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] 

§ 152.50 Contents of application. 

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 


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§ 152.50 40 CFR Ch. I (7–1–11 Edition) 

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 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. (1) 

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 chemical 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 or exemption 

from the requirement of a tolerance 

issued under section 408 of the Federal 

Food, Drug and Cosmetic Act (FFDCA). 

(2) If such residues have not been authorized, the application must be accompanied by a petition for establishment of appropriate tolerances or exemptions from the requirement of a 

tolerance, in accordance with part 180 

of this chapter. 

(j) Fees. (1) The applicant shall identify the appropriate fee category in the 

schedule provided for by FIFRA sec. 33, 


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Environmental Protection Agency § 152.81 

and shall submit the fee for that category as prescribed by the latest EPA 

notice of section 33 fees. 

(2) If FIFRA sec. 33 is not in effect, 

the applicant shall submit any fees required by subpart U of this part, if applicable. 

[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; 73 FR 75594, 

Dec. 12, 2008] 

§ 152.55 Where to send applications 

and correspondence. 

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] 

Subpart E—Procedures To Ensure 

Protection of Data Submitters’ 

Rights 

SOURCE: 49 FR 30903, Aug. 1, 1984, unless 

otherwise noted. 

§ 152.80 General. 

This subpart E describes the information that an applicant must submit 

with his application for registration or 

amended registration to comply (and 

for the Agency to determine compliance) with the provisions of FIFRA sec. 

3(c)(1)(F). 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. 

[73 FR 75594, Dec. 12, 2008] 

§ 152.81 Applicability. 

(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; 

(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; 


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§ 152.83 40 CFR Ch. I (7–1–11 Edition) 

(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. 

As used in this subpart, the following 

terms shall have the meanings set 

forth in this section: 

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. 

Data Submitters List means the current Agency list, entitled ‘‘Pesticide 

Data Submitters by Chemical,’’ of persons who have submitted data to the 

Agency. 

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 first registration. 

Original data submitter means the person who possesses all rights to exclusive use or compensation under FIFRA 

section 3(c)(1)(F) 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)(F) 

have been transferred, or the authorized representative of a group of joint 

data developers. 

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. 

[49 FR 30903, Aug. 1, 1984, as amended at 73 

FR 75595, Dec. 12, 2008] 

§ 152.84 When materials must be submitted to the Agency. 

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. 


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Environmental Protection Agency § 152.86 

§ 152.85 Formulators’ exemption. 

(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 

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. 

An applicant may comply with this 

subpart by citing all data in Agency 

files that are pertinent to its consideration of the requested registration 


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§ 152.90 40 CFR Ch. I (7–1–11 Edition) 

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 

(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)(F) 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)(F) 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)(F) 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. 

[49 FR 30903, Aug. 1, 1984, as amended at 73 

FR 75595, Dec. 12, 2008] 

§ 152.90 The selective method. 

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. 


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Environmental Protection Agency § 152.93 

(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 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. 

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. 

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. 

§ 152.93 Citation of a previously submitted valid study. 

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 


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22 

§ 152.94 40 CFR Ch. I (7–1–11 Edition) 

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)(F)(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)(F); 

(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 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). 

[49 FR 30903, Aug. 1, 1984, as amended at 73 

FR 75595, Dec. 12, 2008] 

§ 152.94 Citation of a public literature 

study or study generated at government expense. 

(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)(F). 

[49 FR 30903, Aug. 1, 1984, as amended at 73 

FR 75595, Dec. 12, 2008] 

§ 152.95 Citation of all studies in the 

Agency’s files pertinent to a specific 

data requirement. 

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 


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Environmental Protection Agency § 152.96 

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)(F); 

(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. 

[49 FR 30903, Aug. 1, 1984, as amended at 73 

FR 75595, Dec. 12, 2008] 

§ 152.96 Documentation of a data gap. 

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 


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§ 152.97 40 CFR Ch. I (7–1–11 Edition) 

(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 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. 

(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. 

A person who possesses rights to exclusive use or compensation under 

FIFRA section 3(c)(1)(F) 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: 

(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; 


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Environmental Protection Agency § 152.99 

(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)(F), unless a new transfer agreement is submitted to the Agency. 

[49 FR 30903, Aug. 1, 1984, as amended at 73 

FR 75595, Dec. 12, 2008] 

§ 152.99 Petitions to cancel registration. 

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. 

(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)(F). 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. 


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§ 152.100 40 CFR Ch. I (7–1–11 Edition) 

(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)(F)(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)(F), 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 requirements and procedures of FIFRA section 3(c)(1)(F) or 

of this subpart, in the manner described by the petitioner. A decision 

following a hearing shall be final. 

[49 FR 30903, Aug. 1, 1984, as amended at 73 

FR 75595, Dec. 12, 2008] 

Subpart F—Agency Review of 

Applications 

SOURCE: 53 FR 15980, May 4, 1988, unless 

otherwise noted. 

§ 152.100 Scope. 

(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. 

The Agency will issue in the FEDERAL

REGISTER a 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 the FEDERAL REGISTER a 


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Environmental Protection Agency § 152.111 

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. 

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. 

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, 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. 

(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. 

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. 

The Agency will complete its review 

of applications as expeditiously as possible. Applications subject to specific 

timeframes under the fee schedule established by FIFRA section 33 will be 

reviewed within the timeframes established for the application or action 

type. 

[73 FR 75595, Dec. 12, 2008] 

§ 152.111 Choice of standards for review of applications. 

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 


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§ 152.112 40 CFR Ch. I (7–1–11 Edition) 

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 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). 

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 for the product 

by part 158 or part 161 of this chapter, 

as applicable. 

(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, 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; 73 FR 75595, Dec. 12, 

2008] 

§ 152.113 Approval of registration 

under FIFRA sec. 3(c)(7)—Products 

that do not contain a new active ingredient. 

(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); 

(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 


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Environmental Protection Agency § 152.115 

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. 

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. 

(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. 

(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. 


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§ 152.116 40 CFR Ch. I (7–1–11 Edition) 

(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. 

(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)(F)(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. 

[53 FR 15980, May 4, 1988, as amended at 73 

FR 75595, Dec. 12, 2008] 

§ 152.117 Notification to applicant. 

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. 

(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 the FEDERAL 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. 

(a) The information submitted to 

support a registration application shall 

be part of the official Agency file for 

that registration. 


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Environmental Protection Agency § 152.130 

(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 

SOURCE: 53 FR 15983, May 4, 1988, unless 

otherwise noted. 

§ 152.122 Currency of address of 

record and authorized agent. 

(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 the FEDERAL REGISTER a 

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. 

(b) The registrant must also notify 

the Agency if he changes his authorized agent. 

§ 152.125 Submission of information 

pertaining to adverse effects. 

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, the registrant 

shall, in accordance with FIFRA section 6(a)(2) and the requirements of 

part 159, subpart D of this chapter, provide such information to the Agency, 

clearly identified as FIFRA 6(a)(2) 

data. 

[73 FR 75595, Dec. 12, 2008] 

§ 152.130 Distribution under approved 

labeling. 

(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 


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§ 152.132 40 CFR Ch. I (7–1–11 Edition) 

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. 

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 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. 

(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; 


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Environmental Protection Agency § 152.164 

(6) A description of the general nature of the underlying transaction, 

e.g., merger, spinoff, bankruptcy 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 section 

3(c)(1)(F) 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; 73 FR 75595, Dec. 12, 

2008] 

Subpart H [Reserved] 

Subpart I—Classification of 

Pesticides 

SOURCE: 53 FR 15986, May 4, 1988, unless 

otherwise noted. 

§ 152.160 Scope. 

(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. 

§ 152.161 Definitions. 

In addition to the definitions in 

§152.3, the following terms are defined 

for the purposes of this subpart: 

(a) Dietary LC50 means 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. 

(a) Grouping of products for classification purposes. In its discretion, the 

Agency may identify a group of products having common characteristics or 


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§ 152.166 40 CFR Ch. I (7–1–11 Edition) 

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. 

(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. 

(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. 

Unless modified by the Agency, the 

compliance dates in this section shall 

apply to restricted use products. 


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Environmental Protection Agency § 152.170 

(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. 

§ 152.168 Advertising of restricted use 

products. 

(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. 

(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: 


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§ 152.170 40 CFR Ch. I (7–1–11 Edition) 

(i) The pesticide, as diluted for use, 

has an acute oral LD50 of 1.5 g/kg or 

less; 

(ii) The pesticide, as formulated, has 

an acute dermal LD50 of 2000 mg/kg or 

less; 

(iii) The pesticide, as formulated, has 

an acute inhalation LC50 of 0.5 mg/liter 

or less, based upon a 4-hour 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 LD50 of 50 mg/kg or less; 

(ii) The pesticide, as formulated, has 

an acute dermal LD50 of 200 mg/kg or 

less; 

(iii) The pesticide, as diluted for use, 

has an acute dermal LD50 of 16 g/kg or 

less; 

(iv) The pesticide, as formulated, has 

an acute inhalation LC50 of 0.05 mg/ 

liter or less, based upon a 4-hour 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 

LC50 for non-target aquatic organisms 

likely to be exposed; or 

(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 LD50 of 

50 mg/kg or less as determined by extrapolation from tests conducted with 

technical material or directly with the 

formulated product; and 


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Environmental Protection Agency § 152.175 

(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. 

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. 

§ 152.175 Pesticides classified for restricted use. 

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 Formulation Use pattern Classification 1 Criteria influencing restriction 

Acrolein ............. As sole active ingredient. No mixtures registered.All uses ................... Restricted ......... Inhalation hazard to humans. Residue effects on 

avian species and aquatic 

organisms. 

Aldicarb ............. As sole active ingredient .................. Ornamental uses 

(indoor and outdoor).

......do ............... Other hazards—accident 

history. 

No mixtures registered ..................... Agricultural crop 

uses.

Under further 

evaluation.

Aluminum 

phosphide.

As sole active ingredient. No mixtures registered.......do ...................... ......do ............... Inhalation hazard to humans. 

Azinphos methyl All liquids with a concentration greater than 13.5 pct.......do ...................... ......do ............... Do. 

All other formulations ........................ ......do ...................... Under futher 

evaluation..


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§ 152.175 40 CFR Ch. I (7–1–11 Edition) 

Active ingredient Formulation Use pattern Classification 1 Criteria influencing restriction 

Carbofuran ........ All concentrate suspensions and 

wettable powders 40% and greater.

......do ...................... ......do ............... Acute inhalation toxicity. 

All granular formulations ................... Rice ........................ Under evaluation.

All granular and fertilizer formulations.All uses except rice ......do.

Chloropicrin ...... All formulations greater than 2% ...... All uses ................... ......do ............... Acute inhalation toxicity. 

All formulations ................................. Rodent control ........ ......do ............... Hazard to non-target organisms. 

All formulations 2% and less ............ Outdoor uses (other 

than rodent control).

Unclassified.

Clonitralid .......... All wettable powders 70% and greater.All uses ................... Restricted ......... Acute inhalation toxicity. 

All granulars and wettable powders Molluscide uses ...... Restricted ......... Effects on aquatic organisms. 

Pressurized sprays 0.55% and less Hospital antiseptics Unclassified.

Dicrotophos ...... All liquid formulations 8% and greater.All uses ................... Restricted ......... Acute dermal toxicity; residue effects on avian species (except for tree injections). 

Disulfoton .......... 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.

......do ...................... Restricted ......... Do. 

Acute inhalation toxicity. 

Non-aqueous solution 95% and 

greater.

Commercial seed 

treatment.

Restricted ......... Acute dermal toxicity. 

Granular formulations 10% and 

greater.

Indoor uses (greenhouse).......do ............... Acute inhalation toxicity. 

Ethoprop ........... Emulsifiable concentrates 40% and 

greater.

Aquatic uses ........... ......do ............... Acute dermal toxicity. 

All granular and fertilizer formulations.All uses ................... Under evaluation.

Ethyl parathion All granular and dust formulations 

greater than 2 pct, fertilizer formulations, wettable powders, emulsifiable concentrates, concentrated 

suspensions, concentrated solutions.

......do ...................... Restricted ......... Inhalation hazard to humans. Acute dermal toxicity. Residue effects on 

mammalian, aquatic, 

avian species. 

Smoke fumigants .............................. ......do ...................... ......do ............... Inhalation hazard to humans. 

Dust and granular formulations 2 pct 

and below.

......do ...................... ......do ............... Other hazards—accident 

history. 

Fenamiphos ...... Emulsifiable concentrates 35% and 

greater.

......do ...................... ......do ............... Acute dermal toxicity. 

Fonofos ............. Emulsifiable concentrates 44% and 

greater.

......do ...................... ......do ............... Acute dermal toxicity. 

Emulsifiable concentrates 12.6% 

and less with pebulate 50.3% and 

less.

Tobacco .................. Unclassified.

Methamidophos Liquid formulations 40% and greater ......do ...................... Restricted ......... Acute dermal toxicity; residue effects on avian species. 

Dust formulations 2.5% and greater ......do ...................... ......do ............... Residue effects on avian 

species. 

Methidathion ..... All formulations ................................. All uses except 

nursery stock, 

safflower and 

sunflower.

......do ............... Do. 

All formulations ................................. Nursery stock, safflower and sunflower.

Unclassified.

Methomyl .......... As sole active ingredient in 1 pct to 

2.5 baits (except 1 pct fly bait).

Nondomestic outdoors-agricultural 

crops, ornamental 

and turf. All other 

registered uses.

Restricted ......... Residue effects on mammalian species. 


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Environmental Protection Agency § 152.175 

Active ingredient Formulation Use pattern Classification 1 Criteria influencing restriction 

All concentrated solution formulations.......do ...................... ......do ............... Other hazards-accident history. 

90 pct wettable powder formulations 

(not in water soluble bags).

......do ...................... ......do ............... Do. 

90 pct wettable powder formulation 

in water soluble bags.

......do ...................... Unclassified.

All granular formulations ................... ......do ...................... ......do.

25 pct wettable powder formulations ......do ...................... ......do.

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.

Methyl bromide All formulations in containers greater 

than 1.5 lb.

All uses ................... Restricted ......... Do. 

Containers with not more than 1.5 lb 

of methyl bromide with 0.25 pct to 

2.0 pct chloropicrin as an indicator.

Single applications 

(nondomestic 

use) for soil treatment in closed 

systems.

Unclassified.

Container with not more than 1.5 lb 

having no indicator.

All uses ................... Restricted ......... Do. 

Methyl parathion All dust and granular formulations 

less than 5 pct.

......do ...................... ......do ............... Other hazards-accident history. All foliar applications 

restricted based on residue effects on mammalian and avian species. 

Microencapsulated ............................ ......do ...................... ......do ............... Residue effects on avian 

species. Hazard to bees. 

All dust and granular formulations 5 

pct and greater and all wettable 

powders and liquids.

......do ...................... ......do ............... Acute dermal toxicity. Residue effects on mammalian and avian species. 

Nicotine (alkaloid).Liquid and dry formulations 14% and 

above.

Indoor (greenhouse) ......do ............... Acute inhalation toxicity. 

All formulations ................................. Applications to cranberries.......do ............... Effects on aquatic organisms. 

Liquid and dry formulations 1.5% 

and less.

All uses (domestic 

and nondomestic).

Unclassified.

Paraquat (dichloride) and 

paraquat 

bis(methyl sulfate).

All formulations and concentrations 

except those listed below.

All uses ................... Restricted ......... Other hazards. Use and accident history, human toxicological data. 

Pressurized spray formulations containing 0.44 pct Paraquat 

bis(methyl sulfate) and 15 pct petroleum distillates as active ingredients.

Spot weed and 

grass control.

......do.

Liquid fertilizers 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.

All uses ................... Unclassified.

Phorate ............. Liquid formulations 65% and greater ......do ...................... Restricted ......... Acute dermal toxicity.

Residue effects on avian 

species (applies to foliar 

applications only). 

Residue effects on mammalian species (applies to 

foliar application only). 

All granular formulations ................... Rice ........................ ......do ............... Effects on aquatic organisms. 

Phosphamidon .. Liquid formulations 75% and greater ......do ...................... ......do ............... Acute dermal toxicity. 

Residue effects on mammalian species. 

Residue effects on avian 

species. 

Dust formulations 1.5% and greater ......do ...................... ......do ............... Do. 

Residue effects on mammalian species. 


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§ 152.400 40 CFR Ch. I (7–1–11 Edition) 

Active ingredient Formulation Use pattern Classification 1 Criteria influencing restriction 

Picloram ............ All formulations and concentrations 

except tordon 101 R.

......do ...................... ......do ............... Hazard to nontarget organisms (specifically nontarget plants both crop and 

noncrop). 

Tordon 101 R forestry herbicide containing 5.4 pct picloram and 20.9 

pct 2.4–D.

Control of unwanted 

trees by cut surface treatment.

Unclassified.

Sodium cyanide 3.

All capsules and ball formulations .... All uses ................... Restricted ......... Inhalation hazard to humans. 

Sodium 

fluoroacetate.

All solutions and dry baits ................ ......do ...................... ......do ............... Acute oral toxicity. Hazard 

to nontarget organisms. 

Use and accident history. 

Strychnine ......... All dry baits, pellets and powder formulations greater than 0.5 pct.......do ...................... ......do ............... Acute oral toxicity. Hazard 

to nontarget avain species. Use and accident 

history. 

All dry baits, pellets and powder formulations.All uses calling for 

burrow builders.

......do ............... Hazard to nontarget organisms. 

All dry baits, pellets and powder formulations 0.5 pct and below.All uses except subsoil.......do ............... Do. 

......do ................................................ All subsoil uses ...... Unclassified.

Sulfotepp .......... Sprays and smoke generators ......... All uses ................... Restricted ......... Inhalation hazard to humans. 

Zinc Phosphide All formulations 2% and less ............ All domestic uses 

and non-domestic 

uses in and 

around buildings.

Unclassified.

All dry formulations 60% and greater..

All bait formulations .......................... Non-domestic outdoor uses (other 

than around buildings).

......do ............... Hazard to non-target organisms. 

All dry formulations 10% and greater Domestic uses ........ ......do ............... 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. 2Percentages 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] 

Subpart U—Registration Fees 

SOURCE: 53 FR 19114, May 26, 1988, unless 

otherwise noted. 

§ 152.400 Purpose. 

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. 

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. 

(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 


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Environmental Protection Agency § 152.408 

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 application. For purposes of this paragraph, 

examples of major changes include but 

are not limited to, changes from nonfood 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 smallscale 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. 

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 Fee 

New chemical ........................................................ $184,500 

New biochemical or microbial ............................... 64,000 

New use pattern .................................................... 33,800 

Experimental use permit ........................................ 4,500 

Old chemical .......................................................... 4,000 

Amendment ........................................................... 700 

[53 FR 19114, May 26, 1988, as amended at 58 

FR 34203, June 23, 1993] 

§ 152.406 Submission of supplementary 

data. 

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. 

(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 


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§ 152.410 40 CFR Ch. I (7–1–11 Edition) 

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. 

(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 the FEDERAL

REGISTER as 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 the FEDERAL

REGISTER. 

§ 152.412 Waivers and refunds. 

(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. 

(2) IR–4. Fees will be waived for registration actions that are determined 

to be specifically associated with tolerance petitions submitted by the InterRegional 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 


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Environmental Protection Agency § 152.500 

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. 

(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. 

[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] 

Subpart Z—Devices 

§ 152.500 Requirements for devices. 

(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. 


wreier-aviles on DSK7SPTVN1PROD with CFR
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Pt. 153 40 CFR Ch. I (7–1–11 Edition) 

(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 the FEDERAL REGISTER of 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] 

PART 153—REGISTRATION POLICIES 

AND INTERPRETATIONS 

Subparts A–F [Reserved] 

Subpart G—Determination of Active and 

Inert Ingredients 

Sec. 

153.125 Criteria for determination of pesticidal activity. 

Subpart H—Coloration and Discoloration of 

Pesticides 

153.140 General. 

153.155 Seed treatment products. 

Subparts I–M [Reserved] 

AUTHORITY: 7 U.S.C. 136w. 

Subparts A–F [Reserved] 

Subpart G—Determination of 

Active and Inert Ingredients 

SOURCE: 53 FR 15989, May 4, 1988, unless 

otherwise noted. 

§ 153.125 Criteria for determination of 

pesticidal activity. 

(a) An ingredient will be considered 

an active ingredient if it is contained 

in a pesticide product and: 

(1) The ingredient has the capability 

by itself, and when used as directed at 

the proposed use dilution, to function 

as a pesticide; or 

(2) The ingredient has the ability to 

elicit or enhance a pesticidal effect in 

another compound whose pesticidal activity is substantially increased due to 

the interaction of the compounds. 

Compounds which function simply to 

enhance or prolong the activity of an 

active ingredient by physical action, 

such as stickers and other adjuvants, 

are not generally considered to be active ingredients. 

(b) Normally the applicant will determine and state in his application 

whether an ingredient is active or inert 

with respect to pesticidal activity. The 

Agency, as part of its review of an application for registration, or in conjunction with the Registration Standard or Special Review process, may require any ingredient, to be designated 

as an active ingredient if the Agency 

finds that it meets the criteria in paragraph (a) of this section. Conversely, 

the Agency may determine that any ingredient designated as active by an applicant is an inert ingredient if it fails 

to meet those criteria. 

(c) If an ingredient is designated as 

an active ingredient, it must be identified in the label ingredients statement. 

If an ingredient is designated as an 

inert ingredient, it must be included as 

part of the total inert ingredients in 

the label ingredients statement. 

(d) Designation of a substance as a 

pesticidally inert ingredient does not 

relieve the applicant or registrant of 

other requirements of FIFRA with respect to labeling of inert ingredients or 

submission of data, or from the requirements of the Federal Food, Drug, 


wreier-aviles on DSK7SPTVN1PROD with CFR