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Pesticide Registration

Pesticide Registration Manual: Chapter 1 -

Overview of Requirements for Pesticide

Registration and Registrant Obligations

Registration Manual Table of Contents

Pesticides Registration Manual Home Page

Introduction

1. Requirements for Pesticide Registration and Registrant Obligations

2. Registering a Pesticide Product

3. AdditionalConsiderations for Biopesticide Products

4. AdditionalConsiderations for Antimicrobial Products

5. Registration Fees

6. Amending a Registered Pesticide Product

7. Notifications and Minor Formulation Amendments

8. Inert Ingredients

9. Supplemental Distribution of a Registered Pesticide

10. Data Compensation Requirements

11. Tolerance Petitions

12. Applying for an Experimental Use Permit

13. Devices

14. How to Obtain an EPA Establishement Number

15. Submitting Data and ConfidentialBusiness Information

16. Transfer of Product Registrations and Data Rights

17. State Regulatory Authority

18. Other Federal or State Agency Requirements

19. How to Obtain Publications

20. Forms and How to Obtain Them

21. Directions for Submitting Applications and Contacting EPA

Appendices
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Appendix A: Guidance Documents

Appendix B: Examples of Registrant Documents

Appendix C: Pesticide Forms Overview Table

Appendix D: Examples of Completed Forms

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In this Chapter

Introduction

Laws and Regulations Pertaining to Pesticide Registration

Identifying Which Products Require Registration

Substances vs. Devices

Definition of Intent

Toxicity to Humans and Nontarget Organisms

Products or Substances that Are Regulated but Not Registered as

Pesticides

Adjuvants

Devices

Pesticide Intermediates

Pesticides Intended for Use on Food or Feed

Import and Export of Pesticides

Types of Pesticide Registration

Obtaining a Registration for a Pesticide Product

Obtaining a SupplementalRegistration to Distribute a

Product Registered by Someone Else

Amending the Registration of a Product Already Registered

with EPA

Unconditional/ConditionalRegistration

Registrant Obligations

State Pesticide Regulatory Agencies

Enforcement and Compliance

Contacts for AdditionalInformation

References Cited in Chapter 1

Intoduction
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This chapter provides an overview of the federal laws that govern EPA’s oversight of

pesticide use in the United States. The chapter also introduces concepts further

elaborated in later chapters of this manual, such as which products are subject to EPA’s

review, how EPA evaluates a pesticide chemical’s toxicity to humans or other

organisms, how EPA evaluates a chemical’s environmentalrisk, how EPA evaluates

pesticides intended for use on food crops and nonfood sites, different types of EPA

responses, role ofstate regulations, and obligations of companies and individuals

seeking a pesticide registration (referred to as "applicants").

Laws and Regulations Pertaining to Pesticide

Registration

The primary federal law that governs how EPA oversees pesticide use in the United

States is the FederalInsecticide, Fungicide, and Rodenticide Act (FIFRA), originally

enacted in 1947. This law has been significantly amended several times, notably in the

recent past by the Food Quality Protection Act of 1996 (FQPA) and by the Pesticide

Registration Improvement Act of 2003 (PRIA), which was reauthorized by the

Pesticide Registration Improvement Extension Act of 2012.

FQPA significantly strengthened the safety criteria in the Federal

Food, Drug, and Cosmetic Act (FFDCA), under which EPA

evaluates pesticide uses on food crops.

PRIA established pesticide registration fees for some registration

actions, under which applicants are required to pay a fee and, in

exchange, EPA is obligated to perform certain registration functions

within defined timeframes.

EPA also derives its authority to regulate pesticide residues on food items from

provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). FIFRA and

FFDCA require EPA to carefully evaluate any pesticide intended for use on food or

animalfeed crops before making a registration decision. If EPA determines that use of

the product would result in residues of the chemical(s) in or on food/feed items, the

Agency may not register the product under FIFRA unless EPA can determine that the

residues are "safe" under the FFDCA. The FFDCA defines "safe" to mean that there is

"a reasonable certainty of no harm" from the exposure to the residue in food and from

other non-occupationalsources.

After making a determination as to safety, the Agency may establish a "tolerance," i.e., a

maximum permissible pesticide residue on a particular food/feed commodity.

Alternatively, EPA may establish an exemption from the requirement of a tolerance,

which would allow any amount of a pesticide residue to remain in or on food or feed, if

EPA determines that granting the exemption would meet the FFDCA safety standard.
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There is a more detailed discussion of the FFDCA requirements and pesticide

tolerances later in the "Pesticides Intended for Use on Food or Feed” section of this

chapter.

Further legal and technical authority regarding how EPA regulates pesticides in the

United States is found in FIFRA’s implementing regulations at Title 40 of the Code of

FederalRegulations (40 CFR) Parts 150.189. These sections of 40 CFR govern the

sale, distribution and use of pesticides. Persons or companies subject to the law are

responsible for understanding and complying with FIFRA, FFDCA, and the relevant

sections of 40 CFR.

Identifying Which Products Require Registration

For a company to know if EPA must register its pesticide product(s), it is necessary to

know what the law defines as a pesticide. Anyone who plans to sell or distribute a

product in the United States that is intended to control a pest or regulate plant growth

should become familiar with the definition of pesticide in the law and regulations.

The term pesticide, as defined in FIFRA section 2(u) means:

1. any substance or mixture ofsubstances intended for preventing,

destroying, repelling, or mitigating any pest;

2. any substance or mixture ofsubstances intended for use as a plant

regulator, defoliant, or desiccant; and

3. any nitrogen stabilizer.

EPA has listed in 40 CFR 152.6 substances that are excluded from regulation by

FIFRA. Provided they meet the conditions or criteria specified in 40 CFR 152.6, such

substances include liquid chemicalsterilants, nitrogen stabilzers, human drugs, animal

drugs, animalfeeds vitamin hormone products, and products intended to aid the growth

of desirable plants. Further, EPA has listed, in 40 CFR 152.8, fertilizer products that

don’t contain pesticide and products intended to force bees from hives for the collection

of honey as products that are not pesticides because they are not for use against pests.

When other products are not pesticides because they are not intended for a pesticidal

purpose is explained in 40 CFR 152.10.

Substances vs. Devices

The use of the terms substance and mixtures ofsubstances in the definition of pesticide

provides the key to separating pesticides from devices (discussed below). If the

product contains a substance that is intended to prevent, destroy, repel, or mitigate a
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pest or constitutes a plant regulator, defoliant, desiccant, or nitrogen stabilizer, then the

product is considered to be a pesticide and, in general, willrequire registration

(exceptions to registration also discussed below).

If the pest is controlled by physical or mechanical action (as opposed to a substance),

then the product is considered a device and registration by EPA is not required.

However, devices are subject to other provisions of the law, which are more thoroughly

explained in Chapter 13.

Definition of Intent

As set forth at 40 CFR section 152.15, a substance is considered to be intended for a

pesticidal purpose, thus requiring EPA registration, if:

The person who distributes or sells the substance claims, states, or

implies (by labeling or otherwise):

that the substance (either by itself or in combination with any

other substance) can or should be used as a pesticide; or

that the substance consists of or contains an active ingredient

and that it can be used to manufacture a pesticide; or

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

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 pesticidal purpose.

Toxicity to Humans and Nontarget Organisms

Pesticides are substances that prevent, destroy, repel, or mitigate a pest. A product’s

relative toxicity to humans or other nontarget organisms does not make it a pesticide.

However, the product’s toxicity to humans and other organisms is carefully evaluated

during EPA’s registration evaluation process. When EPA determines that a pesticide

product can be registered for use, the Agency has concluded that the use of the

pesticide product will not cause unreasonable adverse effects to humans or the

environment when applied according to the label directions and restrictions.

It is important to become familiar with the other definitions in the law and regulations.

The definitions for devices, active and inert ingredients, and pests are terms that will be

vitalfor fully understanding the definition of a pesticide.
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Active ingredient (A.I.) – "Any substance (or group of

structurally similar substances ifspecified 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 [40 CFR ] § 174.3." 40 CFR

152.3. See also FIFRA 2(a).

Inert ingredient – "Any substance (or group ofstructurally similar

substances if designated by the Agency), other than an active

ingredient, which is intentionally included in a pesticide product,

except as provided by [40 CFR ] § 174.3." 40 CFR 152.3. See

also FIFRA 2(m).

Device – Devices are described in a following section in this

chapter, FIFRA section 2(h) and in detail in Chapter 13.

Pests – This term means "(1) any insect, rodent, nematode, fungus,

weed, or (2) any other form of terrestrial or aquatic plant or animal

life or virus, bacteria, or other micro-organism (except viruses,

bacteria, or other micro-organisms on or in living man or other

living animals) which the [Agency] declares to be a pest under

[FIFRA section 25(c)(1)(PDF).]" FIFRA 2(t).

Important Note: For assistance in determining whether a product is a pesticide or

device under FIFRA, you may contact the Registration Division, the Antimicrobials

Division, or the Biopesticides and Pollution Prevention Division Ombudsmen in the

Office of Pesticide Programs (OPP). The contact should be made in writing and should

include detailed information about the intended uses and composition of the product.

Submission of a proposed labelfor the product would also be helpful. The addresses

and/or FAX numbers for the Regulatory Division Ombudsmen are found in Chapter 21.

Please do not send any confidential information via FAX or e-mail.

Products or Substances that Are Regulated but Not

Registered as Pesticides

Adjuvants

For pesticide regulation, adjuvants are chemicals added to a pesticide by users to

improve the pesticide's efficacy. Agricultural chemical adjuvants are grouped according

to their intended purpose in a tank mix. Examples of adjuvants include:
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acidifying agents,

buffering agents,

anti-foam agents,

defoaming agents,

anti-transpirants,

dyes and brighteners,

compatibility agents,

crop oil concentrates,

oilsurfactants,

deposition agents,

drift reduction agents,

foam markers,

feeding stimulants,

herbicide safeners,

spreaders, extenders,

adhesive agents,

suspension agents,

gelling agents,

synergists,

wetting agents,

emulsifiers,

dispersing agents,

penetrants,

tank and equipment cleaners,

neutralizers,

water absorbents, and

water softeners.

Such agents are often included in pesticide formulations as "other ingredients," in which

case the ingredient is reviewed during registration and any necessary tolerances or

exemptions from the requirement of a tolerance are established. Where a product label

directs the user to add a particular adjuvant before use, the registering division will treat

that adjuvant as if it were an "other ingredient" in making the registration decision, and

will assure that any necessary tolerances or exemptions from the requirement of a

tolerance are established. It also would be within the Agency’s authority to treat any

tank-mixed substance as part of the pesticide (and thus needing an FFDCA tolerance)

in that it met the FIFRA definition of pesticide – i.e., a "mixture" ofsubstances intended

to kill a pest.

Devices

A device is defined in FIFRA section 2(h) 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 humans and other than bacteria, virus, or other
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microorganism on or in living man or other living animals); but not including equipment

used for the application of pesticides) when sold separately.” Tamper-resistant bait

boxes for rodenticides are an example of application equipment that does not fall within

the definition of a device.

Items that depend more upon the performance of a person than on the performance of

the device itself (e.g., flyswatters) are considered devices but are not subject to

regulation.

As already stated, registration is not required for devices although devices are subject to

other provisions of the law. Please refer to Chapter 13 for further information. A

nontechnicalfact sheet on devices is also available.

Pesticide Intermediates

Pesticide "intermediates" are substances that may not themselves be pesticides, but are

used in the synthesis of the active ingredient or the manufacture of the pesticide product.

Examples of intermediates are the starting materials used to synthesize by chemical

reactions or purify a technical grade of the active ingredient. A pesticide intermediate

may be produced at the same site as the final pesticide product or obtained from other

sources. Some pesticide intermediates are also pesticides because they are intended for

a pesticidal purpose. See 40 CFR section 152.15 for examples of what EPA considers

a substance intended for a pesticidal purpose. Pesticide intermediates that are not also

pesticides are not subject to registration under FIFRA but are subject to regulation

under the Toxic Substances Control Act (TSCA). Questions regarding chemicals or

compounds that are not pesticides should be referred to EPA’s Office of Pollution

Prevention and Toxics (OPPT).

Pesticides and Pest Control Organisms Exempt from

Registration Requirements

The following pesticides, pest control organisms, and treated articles are exempt from

the registration requirements of FIFRA under 40 CFR Part 152, Subpart B:

Exemptions for pesticides regulated by another Federal Agency (40 CFR

152.20)
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Certain biological control agents are exempt (except for eucaryotic

microorganisms, including protozoa, algae, and fungi; procaryotic

microorganisms, including bacteria; and viruses).

All living plants intended for use as biological control agents are

exempt from the requirements of FIFRA. However, plantincorporated protectants are not exempt pursuant to this section.

Regulations, including exemptions, for plant-incorporated

protectants are addressed in 40 CFR Part 174.

A nonliquid chemicalsterilant, 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.

Exemptions for pesticides of a character not requiring FIFRA regulation (40

CFR 152.25)

Treated articles or substances that meet the specific criteria of 40

CFR 152.25(a), pheromones and pheromone traps, preservatives

for biologicalspecimens, foods, natural cedar, and certain minimum

risk pesticides listed in 40 CFR 152.25(f)(1) and on the OPP

Pesticide Tolerances Website are exempt.

Pesticides that may be transferred sold or distributed without registration (40

CFR 152.30)

A pesticide transferred between registered establishments operated

by the same producer. (40 CFR 152.30(a))

A pesticide transferred between registered establishments not

operated by the same producer. (40 CFR 152.30(b))

A pesticide distributed or sold under an experimental use permit.

(40 CFR 152.30(c))

A pesticide transferred solely for export. (40 CFR 152.30(d)

A pesticide distributed or sold under an emergency exemption. (40

CFR 152.30(e))

A pesticide transferred for purposes of disposal. (40 CFR

152.30(f))

Existing stocks of a formerly registered product. (40 CFR

152.30(g))
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Pesticides Intended for Use on Food or Feed

EPA establishes maximum residue levels (tolerances) for pesticides in food, including

animalfeed, under section 408 of the Federal Food, Drug, and Cosmetic Act

(FFDCA). In the absence of a tolerance covering pesticide residues in a food, that food

is considered adulterated and subject to seizure. For this reason, EPA regulations

require that all needed tolerances be in place before a FIFRA registration will be

granted.

Specifically, if the proposed product labeling bears instructions for use of the product on

food or feed crops, or if the intended use of the product results or may be expected to

result, directly or indirectly, in pesticide residues in or on food or feed (including

residues of any active ingredient, inert ingredient, metabolite, or degradation product),

the applicant must submit a statement indicating whether a tolerance or an exemption

from the requirement of a tolerance has been established by the Agency under section

408 of the FFDCA for the pesticide residues resulting from the proposed use (40 CFR

152.50(i).

If the appropriate tolerances or exemptions are not in place, the application must be

accompanied by a petition for establishment of appropriate tolerances or exemptions

from the requirement of a tolerance in accordance with 40 CFR Part 180 (40 CFR

152.50(i)). Please refer to Chapter 11 for more detailed information on filing petitions

for a tolerance.

Import and Export of Pesticides

FIFRA section 17 contains import and export requirements for pesticides. Except for

certain exemptions from the requirements of FIFRA listed under 40 CFR Part 152,

Subpart B, FIFRA requires that a registration be obtained from EPA before any person

in any state or foreign country can sell or distribute any pesticide in the United States.

Pesticides produced by foreign manufacturers and imported for sale or distribution in

the United States must comply with allrequirements applicable to domestic producers.

This includes registering the pesticide product (follow the guidance in Chapter 2) and

obtaining an EPA Pesticide-Producing Establishment number before starting production

(follow the guidance in Chapter 14). In addition, regulations require an importer to

submit to EPA a Notice of Arrival of Pesticides and Devices (EPA Form 3540-1)

(PDF) (2 pp, 83k) for review and determination as to whether the shipment should

be sampled and/or permitted entry into the United States.

Technical materials may be imported without registration in sufficient quantities to

formulate a pesticide for which an Experimental Use Permit has been granted if the EUP

application cites the planned import (40 CFR 172.7). Per 40 CFR 152.30(e). The

unregistered product must be labeled in accordance with 40 CFR Part 156.
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FIFRA section 17 states that no pesticide, device, or active ingredient used in

producing a pesticide solely for export to any foreign country shall be deemed in

violation of FIFRA when prepared or packaged to the specifications or directions of the

foreign producer, except that producers ofsuch pesticides, devices, and active

ingredients are subject to FIFRA provisions on labels and labeling (section 2(p)) and

misbranding (sections 2(q)(1)(A), (C), (D), (E), (G), and (H); 2(q)(2)(A), (B), (C)(i)

and (iii); and (D), 7 and 8).

FIFRA section 17(a)(2) and its interpretation in 40 CFR 168.75 further state that

before the export of any pesticide not registered under section 3 or sold under section

6(a)(1) of FIFRA, the foreign purchaser must have signed a Prior Informed Consent

statement acknowledging that the purchaser understands that such pesticide is not

registered for use in the United States and cannot be sold in the United States under

FIFRA. The purchaser must transmit a copy of that statement to an appropriate official

of the government of the importing country. Refer to 40 CFR Part 168, Subpart D, for

more information. Related information can also be found at the pesticides International

Activities Website.

Types of Pesticide Registration

Any company wishing to sell its own pesticide product must either:

obtain a federalregistration for its own product; or

become a supplementalregistrant (often termed a supplemental

distributor or sub-registrant) for a product that is already federally

registered.

These types of registrations, together with amendments to a registration, are described

in more detail below. Before submitting a registration request to EPA, the company

must obtain a company number.

Obtaining a Registration for a Pesticide Product

An applicant who wishes to obtain a registration for its own pesticide product is

responsible for submitting or citing all of the information and data that are required to

support the registration. The information required includes:
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forms,

proposed product labeling,

technical and scientific data that meet the data requirements related

to the specific product the applicant intends to produce, and

statement of how the applicant will comply with any data

compensation requirements.

Registrant Summary of Pesticide Petitions for EPA's Notice of Filing provide a

company with the ability to electronically prepare a pesticide tolerance petition for

submission to EPA.

Chapter 2 contains detailed instructions on how to submit an application for pesticide

registration.

Obtaining a Supplemental Registration to Distribute a Product

Registered by Someone Else

An applicant who does not wish to register and produce its own unique product may

become a supplementalregistrant for another company that has already registered a

product. This supplementalregistration allows the new registrant to market the product

under its own company and brand name. To use the supplementalregistration process,

both parties (the originalregistrant and the supplemental distributor) must:

enter into an agreement with one another,

complete and file a Notice of Supplemental Distribution of a

Registered Pesticide Product (EPA Form 8570-5) (PDF) with

EPA, and

ensure that the supplemental product bears the identical label

language apart from the exceptions listed at 40 CFR 152.132(d).

Two of the exceptions include the supplemental label utilizing a

different product name and the supplemental distributor’s name and

address instead of the registrant’s.

Refer to Chapter 9 for detailed instructions on how to submit an application for

supplemental distribution of a pesticide product.

Amending the Registration of a Product Already Registered with

EPA

If a registrant has a product previously registered with EPA and wishes to make a

change to the registration such as change the formulation or labeling text (i.e., add,

delete, or change formulation components or label precautionary statements, or add or
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change uses), it must file an application to amend its registered product.

Refer to Chapter 6 for detailed instructions on how to submit an application for

amended registration of a pesticide product. There are certain changes that registrants

may make that do not require an amendment application, but simply require that

registrants notify the Agency of the change, and other changes that require no

notification at all. Notifications are discussed in Chapter 7 and in PR Notice 98-10

(PDF) (23 pp, 243 K).

Unconditional/Conditional Registration

EPA has discretion to make pesticide registration decisions under either the

unconditionalregistration criteria of FIFRA section 3(c)(5) or the conditional

registration criteria of FIFRA section 3(c)(7). These are described below.

Unconditional Registration

An application will be approved under the unconditionalregistration criteria only if EPA

has (as listed in 40 CFR 152.112):
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determined that the application was complete and was

accompanied by all materials required by FIFRA, including but not

limited to, evidence that the applicant had complied with the data

compensation requirements;

reviewed allrelevant data in its possession;

determined that no additional data were necessary to make the

determinations required under FIFRA section 3(c)(5) with respect

to the subject product;

determined that the composition of the product is such as to

warrant the proposed efficacy claims for it, if efficacy data were

required;

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;

determined that the product was not misbranded as defined by

FIFRA section 2(q) and 40 CFR Part 156;

determined that, if the proposed labeling bears directions for use on

food, animalfeed, 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 of any active or inert

ingredient of the product in or on food or animalfeed, all necessary

tolerances or exemptions from the requirement of a tolerance, and

food additive regulations have been issued under FFDCA section

408, section 409, or both; and

been notified by the FDA that the product complies with any

requirements imposed by FDA if the product, in addition to being a

pesticide, is a drug within the meaning of FFDCA section 201(q).

Unconditionalregistrations can be granted for a variety of applications – such as

identical/substantially similar (me-toos) (described below), new uses, or new active

ingredients – so long as all criteria above are met.

Conditional Registration under FIFRA 3(c)(7)

EPA may conditionally approve an application for registration or amended registration

of a pesticide product. This may occur if EPA determines that, while a registration

decision can be made, further data, studies, or action by the registrant are required by

EPA. This section further details how EPA grants a conditionalregistration depending

on whether it is a new active ingredient, a new use, or an Identical/Substantially Similar

(formerly "Me Too") product.

Identical/Substantially Similar (Formerly Me-Too) Products:
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EPA may conditionally approve an application for registration or amended registration

of a pesticide product under FIFRA section 3(c)(7)(A) if the Agency determines that:

it possesses all data necessary to make the determinations required

by FIFRA section 3(c)(7)(A) with respect to the pesticide product

that is the subject of the application (including, at a minimum, data

needed to characterize any incrementalrisk that would result from

approval of the application);

the pesticide and proposed uses are identical or substantially similar

to any currently registered pesticide and its uses, or differ only in

ways that would not significantly increase the risk of unreasonable

adverse effects on the environment (See 40 CFR 152.113(b))

(PDF) (2 pp, 146.14 K); and

approving the registration or amendment in the manner proposed

would not significantly increase the risk of any unreasonable

adverse effect on the environment (40 CFR 152.113(a)(2)).

Each registration issued under 3(c)(7)(A) must submit or cite the same data that would

be required for unconditionalregistration of a similar product under FIFRA section 3(c)

(5).

These data must be submitted or cited no later than the time that the data are required

to be submitted for similar pesticide product(s) already registered. If a notice requiring

these data has been issued under FIFRA section 3(c)(2)(B) before the application has

been approved, the applicant must submit or cite those data at the time specified in the

notice.

New Uses: EPA may conditionally amend the registration of a pesticide to permit

additional uses, even if the data concerning the pesticide may be insufficient to support

the unconditionalregistration, if the Agency determines under FIFRA section 3(c)(7)(B)

that:

the applicant has submitted satisfactory data pertaining to the

proposed additional use,

amending the registration would not significantly increase the risk of

any unreasonable adverse effect on the environment, and

Each registration issued under 3(c)(7)(B) must submit or cite the same data that would

be required for unconditionalregistration of a similar product under FIFRA section 3(c)

(5).
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Note: If an applicant is unable to submit an item of data (other than data pertaining to

the proposed additional use) because it has not yet been generated (such as data

required by a data call-in issued by EPA under FIFRA section 3(c)(2)(B)), the Agency

may amend the registration to require the submission of those data at the same time that

the data are required to be submitted with respect to similar pesticides already

registered (FIFRA section 3(c)(7)(B)).

New Active Ingredients: EPA may conditionally register a pesticide containing an

active ingredient not in any currently registered product for a period reasonably

sufficient for the generation and submission of data necessary for registration under

FIFRA section 3(c)(7)(C), if the Agency determines that:

insufficient time has elapsed since the imposition of the data

requirement for those data to be developed, on the condition that

when the Agency receives such data that they do not meet or

exceed risk criteria stated in the regulations issued under FIFRA

and other conditions issued by the Agency;

the use of the pesticide during such period will not cause any

unreasonable risk to the environment; and

the use of the pesticide is in the public interest.

Note: Additionalrequirements for conditionalregistration of new active ingredients are

found in 40 CFR 152.114(b) and (c) (PDF) (1 pp, 143.20 K)

Pesticides that Do Not Qualify for Conditional Registration:

EPA will not approve the conditionalregistration of a pesticide product for a new use if

(40 CFR 152.113(c)):

the pesticide is the subject of a SpecialReview, based on a use of

the product that results in human dietary exposure; and

the proposed new use is for a major food or feed crop, or involves

use on a minor food or feed crop for which there is an effective

alternative registered pesticide that does not meet the risk criteria

associated with human dietary exposure.

Registrant Obligations

Registrants are entirely responsible for their pesticide and pesticide labeling and are

required by FIFRA and EPA regulations (40 CFR Part 152 and 169) to:
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ensure that each production facility is registered and has an

establishment number (and ensure that any contractor facility they

use is registered) (40 CFR 167.20);

maintain a U.S. mailing address (40 CFR 152.122(a));

notify EPA of name and/or address changes (if a registrant changes

its name and/or address and fails to notify EPA of the change(s)

and EPA's good faith attempts to contact the registrant are not

successful, EPA will issue in the FederalRegister a notice of intent

to cancel all of the registrant’s products under FIFRA section 6(b))

(40 CFR 152.122(a));

notify EPA if the authorized agent changes (40 CFR 152.122(b));

provide information on any adverse effects of a pesticide that have

not been previously submitted to the Agency in accordance with

FIFRA section 6(a)(2) (40 CFR 152.125);

ensure that their product labeling is in compliance with FIFRA

(FIFRA 2(q) and 40 CFR Part 156);

ensure that supplemental distributor products and their distributor

product labeling are in compliance with FIFRA (40 CFR Part

152.132);

obtain permission to transfer registration of a product and/or data

to another person (40 CFR 152.135); and

pay the annual pesticide registration maintenance fees.

If a registrant owns the production facility, the registrant must:

register the establishment number(s) for each production facility (40

CFR 167.20);

maintain product data records (40 CFR 169.2); and

report annual production volume (40 CFR 169.2(a)).

Refer to 40 CFR Part 152, Subpart G, and 40 CFR Part 169.

State Pesticide Regulatory Agencies

The registration and use of pesticides are not only regulated by federal laws, but also by

state laws and regulations, which differ from state to state. It is advisable to consult with

each state and U.S. territory for information on their registration requirements. The

National Pesticide Information Center provides the telephone numbers and

addresses for the primary pesticide regulatory agency in each state and U.S. territory.

Exit
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Enforcement and Compliance

EPA's regulatory oversight of pesticides manufactured in, imported to, and/or used in

the United States includes not only the science-based review and decision-making

process performed by the Agency's Office of Pesticide Programs but also oversight to

ensure compliance with federal laws and regulations related to pesticides. These efforts

are conducted by EPA's Office of Enforcement and Compliance Assurance (OECA).

Contacts for Additional Information

The following chapters of this manual are intended to provide detailed information

regarding the pesticide registration process and obligations of applicants and registrants

during that process. However, if during the registration process you require additional

information or clarification concerning a pending application for registration, contact the

Product Manager assigned to the pesticide in your product. A listing of Product

Managers and a sampling of the pesticides they are responsible for can be found in

Chapter 21.

For questions of a general nature that do not pertain to any specific pesticide, or pertain

to a new pesticide active ingredient not yet applied for, contact the respective

Ombudsman for the type of pesticide (i.e., conventional chemical, biopesticide, or

antimicrobial) for which you have a question. A listing of the various Ombudsmen can

be found in Chapter 21.

If you have any questions concerning devices, including whether they are subject to

FIFRA or how to register an establishment, please contact:

U.S. EPA

Toxics and Pesticides Enforcement Division

1200 Pennsylvania Avenue, N.W. (2245A)

Washington, D.C., 20460-0001

Telephone:(202) 564-2325

References Cited in Chapter 1

Refer to Chapter 19 for information on the source of these documents.

Code of FederalRegulation, Title 40
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Part 152 - Pesticide Registration and Classification Procedures

Part 156 - Labeling Requirements for Pesticides and Devices

Part 158 - Data Requirements for Registration

Part 168 - Statements of Enforcement Policies and Interpretations

Part 169 - Books and Records of Pesticide Production and

Distribution

Part 172 - Experimental Use Permits

Part 180 - Tolerances and exemptions from tolerances for pesticide

chemicals in food

Code of FederalRegulation, Title 21

Part 182 - Substance generally recognized as safe

FederalInsecticide, Fungicide, and Rodenticide Act, as amended by the Food

Quality Protection Act of August 3, 1996

Section 2 - Definitions

Section 3 - Registration of pesticides

Section 6 - Administrative review; suspension

Section 7 - Registration of establishments

Section 8 - Books and Records

Section 17 - Imports and Exports

Federal Food, Drug and Cosmetic Act

Section 201 - Definitions

Section 408 - Requirement for Tolerance or Exemption

Last updated on June 26, 2014
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