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Environmental Protection Agency Pt. 172 

by a certified applicator, and he maintains the records required in this subsection. Each restricted use pesticide 

retail dealer shall maintain records at 

each individual dealership of each 

transaction where a restricted use pesticide was made available to an 

uncertified person for use by a certified 

applicator. Records of each such transaction shall be maintained for a period 

of 24 months after the date of the 

transaction, and shall include the following information: 

(A) The name and address of the residence or principal place of business of 

the uncertified person to whom the restricted use pesticide is made available 

for use by a certified applicator. 

(B) The name and address of the residence or principal place of business of 

the certified applicator who will use 

the restricted use pesticide. 

(C) The certified applicator’s certification number, the State (or other governmental unit) that issued his certification document, the expiration date 

of the certification, and the categories 

in which the applicator is certified, if 

appropriate. 

(D) The product name, EPA registration number, and the State special 

local need registration number, granted under section 24(c) of the FIFRA (if 

any) on the label of the pesticide. 

(E) The quantity of the pesticide 

made available for use in the transaction. 

(F) The date of the transaction. 

(G) At the time of each transaction, 

EPA recommends that the dealer obtain the information required in paragraph (g)(2)(ii) (A) through (C) of this 

section and assure himself that the restricted use pesticide is made available 

for use by a certified applicator by examining one of the following sets of 

documents: 

(1) The original of the certified applicator’s certification document, and a 

driver’s license or other State, county, 

or Tribal identification document 

issued to the uncertified person to 

whom the restricted use pesticide is 

made available. 

(2) A photocopy or facsimile of the 

certified applicator’s certification document, together with a statement 

signed by the certified applicator authorizing the uncertified person to purchase the restricted use pesticide on 

his behalf, and a driver’s license or 

other State, county, or Tribal identification document issued to the 

uncertified person to whom the restricted use pesticide is made available. 

(3) A photocopy or facsimile of the 

certified applicator’s certification document, together with a copy of a 

signed contract or agreement, between 

the uncertified person to whom the restricted use pesticide is being made 

available for use and the identified certified applicator, which provides for 

the use of the restricted use pesticide 

by the identified certified applicator, 

and a driver’s license or other State, 

county, or Tribal identification document issued to the uncertified person 

to whom the restricted use pesticide is 

made available. 

(3) Availability of required records. 

Each pesticide dealer shall, upon request of any officer or employee of 

EPA duly designated by the Administrator, furnish or permit such person 

at all reasonable times to have access 

to and copy all records required to be 

maintained under this section. 

(4) Failure to comply. Any person who 

fails to comply with the provisions of 

this rule may be subject to civil or 

criminal sanctions, under section 14 of 

the Act, or 18 U.S.C. 1001. Violations include failure to submit or falsification 

of any report required under this paragraph, failure to maintain or falsification of records as required under this 

section, and making available for use 

any pesticide classified for restricted 

use to a person who is not a certified 

commercial applicator other than in 

accordance with these regulations and 

section 3(d) of the amended FIFRA or 

rules promulgated thereunder. 

[43 FR 24837, June 8, 1978, as amended at 48 

FR 29855, June 29, 1983; 48 FR 53974, Nov. 29, 

1983; 49 FR 17759, Apr. 25, 1984; 58 FR 34203, 

June 23, 1993; 77 FR 39642, July 5, 2012] 

PART 172—EXPERIMENTAL USE 

PERMITS 

Subpart A—Federal Issuance of 

Experimental Use Permits 

Sec. 

172.1 Definitions. 


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§ 172.1 40 CFR Ch. I (7–1–13 Edition) 

172.2 General. 

172.3 Scope of requirement. 

172.4 Applications. 

172.5 The permit. 

172.6 Labeling. 

172.7 Importation of technical material. 

172.8 Program surveillance and reporting of 

data. 

172.9 Renewals. 

172.10 Refusals to issue and revocation. 

172.11 Publication. 

Subpart B—State Issuance of Experimental 

Use Permits 

172.20 Scope. 

172.21 Definitions. 

172.22 General. 

172.23 State plans. 

172.24 State issuance of permits. 

172.25 Administration of State programs. 

172.26 EPA review of permits. 

Subpart C—Notification for Certain 

Genetically Modified Microbial Pesticides 

172.43 Definitions. 

172.45 Requirement for a notification. 

172.46 Submission of a notification. 

172.48 Data requirements for a notification. 

172.50 Response to a notification. 

172.52 Notification exemption process. 

172.57 Submission of information regarding 

potential unreasonable adverse effects. 

172.59 Enforcement. 

AUTHORITY: 7 U.S.C. 136c, 136w. Section 

172.4 is also issued under 31 U.S.C. 9701. 

SOURCE: 40 FR 18782, Apr. 30, 1975, unless 

otherwise noted. 

Subpart A—Federal Issuance of 

Experimental Use Permits 

§ 172.1 Definitions. 

Terms used in this part have the 

same meaning as in the Act. In addition, as used in this part, the following 

terms shall apply: 

Act means the Federal Insecticide, 

Fungicide and Rodenticide Act, as 

amended. 

Applicant means any person who applies for an experimental use permit 

pursuant to section 5 of the Act. 

Cooperator means any person who 

grants permission to a permittee or a 

permittee’s designated participant for 

the use of an experimental use pesticide at an application site owned or 

controlled by the cooperator. 

Experimental animals means individual animals or groups of animals, 

regardless of species, intended for use 

and used solely for research purposes. 

The term does not include animals intended to be used for any food purposes 

Participant means any person acting 

as a representative of the permittee 

and responsible for making available 

for use, or supervising the use or evaluation of, an experimental use pesticide to be applied at a specific application site. 

Permittee means any applicant to 

whom an experimental use permit has 

been granted. 

Value for pesticide purposes means 

that characteristic of a substance or 

mixture of substances which produces 

an efficacious action on a pest. 

[73 FR 75599, Dec. 12, 2008] 

§ 172.2 General. 

(a) Pursuant to section 5 of the Federal Insecticide, Fungicide, and 

Rodenticide Act, as amended (86 Stat. 

983), and except as herein provided by 

§172.3, any person wishing to accumulate information necessary to register 

under section 3 of the Act and the regulations thereunder (1) a pesticide not 

registered with this Agency or (2) a 

registered pesticide for a use not previously approved in the registration of 

the pesticide may apply to the Administrator at any time for an experimental use permit. 

(b) Pesticides under experimental use 

permits may not be sold or distributed 

other than through participants and, if 

sold or distributed through participants, may be used only at an application site of a cooperator and in accordance with the terms and conditions of 

the experimental use permit. 

§ 172.3 Scope of requirement. 

(a) An experimental use permit 

(EUP) is generally required for testing 

of any unregistered pesticide or any 

registered pesticide being tested for an 

unregistered use. However, as described 

in paragraph (b) of this section, certain 

of such tests are presumed not to involve unreasonable adverse effects and, 

therefore, do not require an EUP. 

(b) Except as provided in subpart C of 

this part or as specifically determined 

by the Environmental Protection 

Agency (EPA), it may be presumed 

that EUPs are not required when: 


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Environmental Protection Agency § 172.3 

(1) The experimental use of the pesticide is limited to: 

(i) Laboratory or greenhouse tests, 

(ii) Limited replicated field trials as 

described in paragraph (c) of this section to confirm such tests, or 

(iii) Other tests as described in paragraph (c) of this section whose purpose 

is only to assess the pesticide’s potential efficacy, toxicity, or other properties. 

(2) The producer, applicator, or any 

other person conducting the test does 

not expect to receive any benefit in 

pest control from the pesticide’s use. 

(c) For purposes of paragraphs 

(b)(1)(ii) and (b)(1)(iii) of this section, 

the following types of experimental 

tests are presumed not to need an EUP: 

(1) A small-scale test involving use of 

a particular pesticide that is conducted 

on a cumulative total of no more than 

10 acres of land per pest, except that: 

(i) When testing for more than one 

target pest occurs at the same time 

and in the same locality, the 10 acre 

limitation shall encompass all of the 

target pests. 

(ii) Any food or feed crops involved 

in, or affected by, such tests (including, 

but not limited to, crops subsequently 

grown on such land which may reasonably be expected to contain residues of 

the tested pesticides) shall be destroyed or consumed only by experimental animals unless an appropriate 

tolerance or exemption from a tolerance has been established under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA) for residues of the pesticide. 

(2) A small-scale test involving the 

use of a particular pesticide that is 

conducted on a cumulative total of no 

more than 1 surface acre of water per 

pest, except that: 

(i) When the testing for more than 

one target pest occurs at the same 

time and in the same locality, the 1 

acre limitation shall encompass all of 

the target pests. 

(ii) Waters which are involved in or 

affected by such tests are not used for 

irrigation purposes, drinking water 

supplies, or body contact recreational 

activities. 

(iii) Testing shall not be conducted in 

any waters which contain or affect 

fish, shellfish, plants, or animals taken 

for recreational or commercial purposes and used for food or feed, unless 

an appropriate tolerance or exemption 

from a tolerance has been established 

under the FFDCA for residues of the 

pesticide. 

(3) Animal treatment tests involving 

the use of a particular pesticide that 

are conducted only on experimental 

animals which will not be used for food 

or feed, unless an appropriate tolerance 

or an exemption from a tolerance has 

been established for animal products 

and byproducts under the FFDCA for 

residues of the pesticide. 

(d) The examples in paragraphs (c)(1), 

(c)(2), and (c)(3) of this section are not 

all-inclusive and do not preclude testing in larger areas or larger numbers of 

units if the intended use meets the criteria of paragraph (a) of this section. 

However, tests which do not come 

within the examples in paragraphs 

(c)(1), (c)(2), and (c)(3) of this section, 

absent a specific determination by EPA 

to the contrary, require an EUP. Persons intending to conduct tests who 

are uncertain whether the testing may 

be conducted without a permit may 

submit a request for determination to 

the Office of Pesticide Programs’ Document Processing Desk at the appropriate address as set forth in 40 CFR 

150.17(a) or (b). Such a request shall include the information listed in 

§172.4(b)(1)(ii) and (b)(1)(iii) and in the 

case of an unregistered product, the information in §172.4(b)(3)(i). 

(e) Notwithstanding paragraphs (b) 

through (d) of this section, EPA may, 

on a case-by-case basis, require that 

certain testing of a particular pesticide 

or class of pesticides be carried out 

under an EUP, if it is determined that 

such EPA oversight is warranted. If 

EPA determines that an EUP is required, it will notify the developer of 

the pesticide of the need for an EUP 

and provide opportunity for comment 

or objections before imposing the requirement. 

(f) No EUP is required for a substance 

or mixture of substances being put 

through tests for the sole purpose of 

gathering data required for approval of 

such substance or mixture under the 

FFDCA (21 U.S.C. 301 et seq.) as: 

(1) A ‘‘new drug’’ (21 U.S.C. sec. 321(p) 

and sec. 355). 


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§ 172.4 40 CFR Ch. I (7–1–13 Edition) 

(2) A ‘‘new animal drug’’ (21 U.S.C. 

sec. 321(w) and sec. 360(b)), or 

(3) An ‘‘animal feed’’ (21 U.S.C. sec. 

321 (x)) containing a ‘‘new animal 

drug’’ (21 U.S.C. sec. 360(b)). 

(g) Paragraph (f) of this section shall 

not apply when a purpose of such test 

is to accumulate information necessary 

to register a pesticide under section 3 

of the Act. 

[59 FR 45611, Sept. 1, 1994, as amended at 71 

FR 35546, June 21, 2006; 73 FR 75599, Dec. 12, 

2008] 

§ 172.4 Applications. 

(a) Time for submission. An application 

or request for amendment to an existing permit shall be submitted as far as 

possible in advance of the intended 

date of shipment or use to the Office of 

Pesticide Programs’ Document Processing Desk at the appropriate address 

as set forth in 40 CFR 150.17(a) or (b). 

(b) Contents of applications—(1) General requirements. (i) The name and address of the applicant; 

(ii) The registration number of the 

product, if registered; 

(iii) The purpose or objectives of the 

proposed testing; a description in detail of the proposed testing program including test parameters; a designation 

of the pest organism(s) involved; the 

amount of pesticide product proposed 

for use; the crops, fauna, flora, sites, 

modes, dosage rates, and situation of 

application on or in which the pesticide 

is to be used; the States in which the 

proposed program will be conducted; 

the number of acres, number of structural sites, or number of animals by 

State to be treated or included in the 

area of experimental use; the proposed 

dates or period(s) during which the 

testing program is to be conducted; and 

the manner in which supervision of the 

program will be accomplished; 

(iv) The name, street address, telephone number, and qualifications of all 

participants in the program (whether 

or not in the employ of the applicant). 

A permit must be amended to add or 

change participants; 

(v) The name and street address of all 

cooperators, if available at the time an 

application is submitted or as soon 

thereafter as available; 

(vi) A description and the specific results of any appropriate prior testing 

of the product conducted by the applicant to determine toxicity and effects 

in or on target organisms at the site of 

application; and to determine 

phytotoxicity and other forms of toxicity or effects on nontarget plants, 

animals, and insects at or near the site 

of application; and to determine adverse effects on the environment; 

(vii) The proposed method of storage 

and disposition of any unused experimental use pesticide and its containers; and 

(viii) Such other additional pertinent 

information as the Administrator may 

require. 

(2) Requirement for tolerance. If the experimental use pesticide is to be used 

in such a manner that any residue can 

reasonably be expected to result in or 

on food or feed, the applicant must: 

(i) Submit evidence that a tolerance 

or exemption from the requirement of 

a tolerance has been established for 

residues of the pesticide in or on such 

food or feed under section 408 of the 

Federal Food, Drug, and Cosmetic Act; 

or 

(ii) Submit a petition proposing establishment of a tolerance or an exemption from the requirement of a tolerance under section 408 of the Federal 

Food, Drug, and Cosmetic Act; or 

(iii) Certify that the food or feed derived from the experimental program 

will be destroyed or fed only to experimental animals for testing purposes, or 

otherwise disposed of in a manner 

which will not endanger man or the environment. The method of such destruction or disposition shall be provided in the application for the permit. 

(3) Additional requirements for unregistered pesticide products. (i) A complete 

confidential statement of composition 

for the formulation to be tested giving 

the name and percentage by weight of 

each ingredient, active and inert; 

(ii) Chemical and physical properties 

of each active ingredient of the formulation to be tested, including, but not 

limited to, the manufacturing or laboratory processes and analytical methods suitable for determining the active 

ingredients in the formulation; 

(iii) Appropriate date, if available, on 

the rate of decline of residues on the 

treated crop or environmental site or 

other information for determination 


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Environmental Protection Agency § 172.7 

regarding entry of persons into treated 

areas; and 

(iv) Results of toxicity tests and 

other data relevant to the product’s potential for causing injury to the users 

or other persons who may be exposed, 

including any available epidemiological information as to man. 

(c) Fees. The payment of fees for experimental use permits shall apply as 

specified in subpart U of part 152 of the 

chapter. 

[40 FR 18782, Apr. 30, 1975, as amended at 53 

FR 19115, May 26, 1988; 71 FR 35546, June 21, 

2006; 73 FR 75599, Dec. 12, 2008] 

§ 172.5 The permit. 

(a) Issuance. The Experimental Use 

Permit shall be issued when the Administrator determines that the conditions of section 5 of the Act, and the 

regulations thereunder, have been met 

subject to such terms and conditions as 

the Administrator determines are warranted. 

(b) Duration. Permits will be effective 

for a specified period of time, normally 

one year, depending upon the crop or 

site to be tested and the requirements 

of the testing program submitted. The 

applicant should propose a suitable duration of the permit commensurate 

with the program submitted. Permits 

and associated temporary tolerances 

may be renewed, extended, or amended 

upon request if circumstances warrant. 

(c) Limitations. The quantity of a pesticide allowed by a permit may be less 

than requested if it is determined that 

the available information on efficacy, 

toxicity or other hazards, the need for 

data, or the adequacy of program supervision does not justify the quantity 

of the pesticide requested. Other limitations may also be placed in the permit if necessary for the protection of 

the public health and the environment. 

(d) Additions. With respect to an experimental use pesticide containing 

any chemical or combination of chemicals not included in any previously registered pesticides, the Administrator 

may require that additional studies be 

conducted during the permit period to 

gather data to support the establishment of tolerances and/or registration. 

To the extent practicable, the applicant will be notified of any such requirements before or at the time an experimental use permit is issued. 

(e) Maintenance of records. All producers of pesticides produced pursuant 

to an experimental use permit shall 

maintain records in accordance with 

part 169. 

§ 172.6 Labeling. 

(a) Contents. Except as provided by 

paragraph (b) of this section, all pesticides shipped or used under an experimental use permit shall be labeled with 

directions and conditions for use which 

shall include the following: 

(1) The prominent statement, ‘‘For 

Experimental Use Only’’; 

(2) The Experimental Use Permit 

number; 

(3) The statement, ‘‘Not for sale to 

any person other than a participant or 

cooperator of the EPA-approved Experimental Use Program’’; 

(4) The name, brand, or trademark; 

(5) The name and address of the permittee, producer, or registrant; 

(6) The net contents; 

(7) An ingredient statement; 

(8) Warning or caution statements; 

(9) Any appropriate limitations on 

entry of persons into treated areas; 

(10) The establishment registration 

number, except in those cases where 

application of the pesticide is made 

solely by the producer; and 

(11) The directions for use, except 

that the Administrator may approve 

the use of the experimental program as 

labeling provided that such program is 

to be distributed with the product. 

(b) Supplemental labeling. In the case 

of a registered pesticide, the Administrator may, at his discretion, permit a 

pesticide to be used under an experimental use permit with supplemental 

labeling as approved by him. 

§ 172.7 Importation of technical material. 

Technical materials may be imported 

without registration in sufficient quantities to formulate a pesticide for 

which an Experimental Use Permit has 

been requested if the application for 

such permit states that such importation will occur. 


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§ 172.8 40 CFR Ch. I (7–1–13 Edition) 

§ 172.8 Program surveillance and reporting of data. 

(a) The permittee shall supervise the 

test program and evaluate the results 

of testing at each site of application. It 

will further be the responsibility of the 

permittee to report immediately to the 

Administrator, or to any person designated by him, any adverse effects 

from use of, or exposure to, the pesticide. 

(b) The permittee shall submit the 

following reports to the Registration 

Division during the experimental program. 

(1) [Reserved] 

(2) A final report shall be submitted 

within 180 days after the expiration of 

the permit, unless a request for extension of time is approved, and shall include: 

(i) All data gathered during the testing program; field notes need not be 

submitted but must be maintained and 

submitted upon request; 

(ii) A description of the disposition of 

any pesticide containers and any unused pesticides including amounts disposed of and the method and site of disposition; and 

(iii) The method of disposition of affected food and/or feed. 

The data under paragraph (b)(2)(i) of 

this section above may be submitted as 

part of an application for registration 

submitted within 180 days after the expiration of the permit, provided that 

the final report shall include a statement that such application has been 

made, and the date of such application. 

(c) In addition to the reporting requirements provided for elsewhere in 

this part, in the case of any meat-producing animals or birds that receive a 

direct treatment or application of any 

experimental use pesticide, the name 

and location of the packing plant 

where the animals will be processed 

shall be sent to the U.S. Department of 

Agriculture, Animal and Plant Health 

Inspection Service, Washington, DC 

20250, at least 10 days before the animals are to be shipped for slaughter. 

This requirement may be waived, on 

request, by the USDA. These provisions 

do not exempt treated food-producing 

animals and their products from compliance with other applicable inspection requirements. 

(d) Failure to submit required reports 

may constitute grounds for revocation 

of the permit. 

(e) For the purpose of supervising the 

use of experimental use pesticides, the 

Agency may require the permittee or 

any participant to give reasonable advance notification of the intended 

dates, times, and sites on which such 

experimental use pesticide will be applied. 

(f) The permittee or participants in 

the experimental use program will permit any authorized representative of 

the Agency, upon presentation of official identification, entry, at any reasonable time, to any premises involved 

in the testing program to inspect and 

to determine whether there has been 

compliance with the terms and conditions of the permit. 

[40 FR 18782, Apr. 30, 1975, as amended at 60 

FR 32097, June 19, 1995] 

§ 172.9 Renewals. 

Applications for renewal of experimental use permits and temporary tolerances, to provide for additional testing, shall be submitted prior to expiration of the permit. Requirements for 

renewals are the same as for applications under §172.4, except that information previously submitted may be incorporated by reference. 

§ 172.10 Refusals to issue and revocation. 

(a) Refusal. At any time that the Administrator determines that an experimental use permit is not justified, or 

that the issuance of such a permit 

would cause unreasonable adverse effects on the environment, or that for 

any other reason provided for under 

the law a permit shall not be issued, he 

shall notify the applicant in writing. 

(b) Revocation. The Administrator 

may revoke an experimental use permit if he finds that its terms or conditions are being violated or that its 

terms or conditions are inadequate to 

avoid unreasonable adverse effects on 

the environment, or if new evidence is 

obtained which demonstrates that the 

tolerance will be inadequate to protect 

the public health, or for failure to meet 

any other provision of this part 172. 

The Administrator will notify the permittee in writing of such revocation. 


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Environmental Protection Agency § 172.22 

The permittee shall notify all participants of such revocation as soon as 

possible after he receives notice of revocation. The revocation of a permit 

shall not preclude the Administrator 

from initiating civil or criminal sanctions for the violations of the permit 

conditions or otherwise as authorized 

by law. 

(c) Hearing. In the event that an applicant for an experimental use permit 

wishes to contest the refusal to issue 

an experimental use permit, or an experimental use permittee wishes to 

contest the revocation of any such permit, he shall, within twenty days after 

receipt of notice of such refusal or revocation, file with the Administrator a 

written request for an opportunity to 

confer with the Administrator or his 

designee. Within twenty days after 

such conference, the applicant or permittee will be notified of the Administrator’s final decision. 

§ 172.11 Publication. 

(a) Notice of receipt of an experimental 

use permit application. The Administrator shall publish notice in the FEDERAL REGISTER of receipt of an application for an experimental use permit 

upon finding that issuance of the experimental use permit may be of regional or national significance. This 

notice shall include: 

(1) The active ingredients, 

(2) Use pattern(s), 

(3) Quantity of pesticide, 

(4) Total acreage, 

(5) Location of area of application, 

(6) A statement soliciting comments 

from any interested persons regarding 

the application. 

(b) Public hearing. The Administrator 

may hold a public hearing, and publish 

notice in the FEDERAL REGISTER of the 

date and location of the hearing, when 

he determines that there is sufficient 

interest in the application to warrant a 

hearing, based upon the comments received in response to the Notice of Receipt of an Application, or that a hearing would otherwise be in the public interest. 

(c) Issuance of experimental use permit. 

The Administrator shall give prompt 

notice in the FEDERAL REGISTER of the 

issuance of an experimental use permit. The notice shall include: 

(1) The active ingredients, 

(2) Use pattern(s), 

(3) Quantity of pesticide, 

(4) Total acreage, 

(5) Location of area of application, 

(6) A statement indicating where the 

experimental use permit is available 

for public inspection. 

Subpart B—State Issuance of 

Experimental Use Permits 

SOURCE: 44 FR 41787, July 18, 1979, unless 

otherwise noted. 

§ 172.20 Scope. 

This subpart sets forth regulations 

governing State issuance of experimental use permits pursuant to section 

5(f) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (FIFRA). It also sets forth regulations governing authorization by the 

Administrator of State experimental 

use permit programs. 

§ 172.21 Definitions. 

Terms used in this subpart shall have 

the meaning set forth in FIFRA and in 

§172.1. 

Designated State agency means the 

State agency designated by State law 

or other authority to be responsible for 

registering pesticides to meet special 

local needs. 

Public or private agricultural research 

agency or educational institution means 

any organization engaged in research 

pertaining to the agricultural use of 

pesticides, or any educational institution engaged in pesticide research. Any 

research agency or educational institution whose principal function is to promote, or whose principal source of income is directly derived from, the sale 

or distribution of pesticides (or their 

active ingredients) does not come within the meaning of this term. 

[73 FR 75599, Dec. 12, 2008] 

§ 172.22 General. 

(a) Experimental use permits are not 

required under this rule in those situations described in §172.3 of subpart A 

pertaining to Federal experimental use 

permits. 

(b) Subpart B is not applicable to experimental use permits issued by a 


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§ 172.23 40 CFR Ch. I (7–1–13 Edition) 

State, as required by State law, to a 

permittee who already holds a valid 

Federal experimental use permit issued 

under subpart A for the same purpose, 

or who is not required to obtain a permit under this rule. 

(c) Pesticide products used under experimental use permits may not be sold 

or distributed other than through participants, and, if sold or distributed 

through participants, may be used only 

at an application site of a cooperator 

and in accordance with the terms and 

conditions of the experimental use permit. 

(d) Establishments in which pesticide 

products under State experimental use 

permits are produced shall be registered as required by 40 CFR 167.2(a) 

and producers of such products shall 

maintain books and records as required 

by 40 CFR 169.2. 

(e) Pesticide products and their containers used under this rule must also 

be packaged, stored, transported, used, 

and disposed of in accordance with all 

applicable Federal laws and regulations, including the Resource Conservation and Recovery Act of 1976 as 

amended (Pub. L. 94–580; 90 Stat. 2795; 

42 U.S.C. 6901 et seq.) (RCRA), and rules 

thereunder. 

§ 172.23 State plans. 

(a) Submission. (1) A State may, by 

submitting a State plan, request the 

Administrator to authorize the designated State agency to issue experimental use permits under section 5(f) 

of FIFRA. 

(2) A State shall request authorization to issue experimental use permits 

by having the Governor or Chief Executive Officer or his designated agent 

submit a State plan in writing to the 

Administrator. 

(b) Contents. A State plan shall include— 

(1) A designation of the State agency 

responsible for the administration of 

the State experimental use permit program. 

(2) An opinion of the State attorney 

general or the legal counsel of the designated State agency that the State 

has the requisite legal authorities as 

set forth in paragraph (c)(1)(i) of this 

section, accompanied by copies of the 

applicable State laws and regulations. 

(3) A description of procedures that 

the designated State agency will follow: 

(i) To review experimental use permit applications, to ensure that experimental use permits will be issued in accordance with the terms and conditions 

of the authorization, FIFRA, and this 

subpart; and 

(ii) To supervise use pursuant to the 

permits, and to ensure that permits are 

used in accordance with their terms 

and conditions, FIFRA, and this subpart. 

(c) Criteria for EPA acceptance of State 

plan. (1) The Administrator shall grant 

authorization to issue experimental 

use permits if the State plan establishes that the designated State agency— 

(i) Has adequate legal authority 

under State law to implement the plan, 

including authority: 

(A) To issue experimental use permits, subject to limitations necessary 

for the protection of public health and 

the environment; 

(B) To supervise the use of a pesticide 

pursuant to an experimental use permit, as provided in §172.25(c); 

(C) To deny an experimental use permit if it determines that a permit is 

not justified, or that the issuance of 

the permit would cause unreasonable 

adverse effects on the environment; 

(D) To amend or revoke an experimental use permit, if the designated 

State agency finds that: 

(1) The terms and conditions of the 

permit are being violated, or are inadequate to avoid unreasonable adverse 

effects on the environment; 

(2) Any required tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 301 et seq.) has been revoked 

by EPA, or any exemption from the requirement for tolerance has been withdrawn by EPA; or 

(3) A failure by the permittee or any 

cooperator to meet any other provision 

of FIFRA or this subpart has occurred; 

(E) To enter, by consent or by warrant or by other legal means, in connection with an experimental use permit, a permittee’s or cooperator’s 

premises at reasonable times in order 

to sample or inspect any pesticides 

used or property treated, to inspect 

any equipment or records kept, or to 


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Environmental Protection Agency § 172.24 

observe any activities conducted, as 

necessary to enforce compliance with 

State law, the terms of the permit, and 

this subpart; 

(F) To comply in all other respects 

with the requirements of this subpart, 

including labeling requirements; and 

(ii) Utilizes procedures for the review 

of each permit which are adequate to 

ensure that the State program will be 

administered in accordance with the 

purposes of FIFRA and this subpart. 

(2) After receiving a State plan, EPA 

shall publish a FEDERAL REGISTER notice announcing the fact and inviting 

interested parties to comment thereon. 

(d) Approval, rejection, and revocation. 

(1) EPA shall approve or reject the 

State plan within 90 days after receipt 

of all information necessary for final 

review of the plan, including copies of 

effective statutes and regulations 

which satisfy the requirements of this 

subpart. 

(2) The Administrator may at any 

time revoke the authorization of a 

State to issue experimental use permits if he determines that the designated State agency has not complied 

with the requirements of this subpart 

or with the terms and conditions of 

such authorization. State experimental 

use permits issued prior to the revocation of authority shall remain valid 

until they expire or until three years 

from the date of revocation of the 

State’s authority, whichever comes 

first, unless sooner revoked by EPA 

under §172.26(c) of this subpart. 

(3) Notices of approval, rejection, and 

revocation shall be published in the 

FEDERAL REGISTER, as well as the basis 

for such approval, rejection, or revocation. 

(4) Prior to rejecting or revoking authorization, the Administrator shall 

notify the State in writing of his intention to take such action, along with 

the basis for such action, and shall afford the State the opportunity for a 

hearing, and time to take corrective 

action. 

§ 172.24 State issuance of permits. 

(a) General. Upon approval of a State 

plan by the Administrator under 

§172.23, the designated State agency is 

authorized to issue, amend, renew, 

deny or revoke experimental use permits subject to the terms of the authorization and these regulations. 

(b) Authority. A designated State 

agency may issue an experimental use 

permit— 

(1) To any person for the purpose of 

gathering the data necessary to support the State registration of a pesticide to meet special local needs under 

section 24(c), FIFRA. 

(2) To any agricultural research 

agency or educational institution conducting work within the State for the 

purpose of experimentation: 

(i) Which is done within the State; 

and 

(ii) Which is not directly intended to 

result in the registration of a specific 

pesticide product. 

(3) For use of a restricted use pesticide only if the pesticide is to be used 

by, or under the direct supervision of, 

an applicator certified in accordance 

with section 11 of FIFRA. 

(c) Limitations. (1) In the case of applicants who need to gather data required to register a pesticide product 

to meet a special local need under section 24(c) of FIFRA, a State may only 

issue experimental use permits for the 

types of pesticide products and uses 

which it has authority to register 

under section 24(c). 

(2) A State may not issue an experimental use permit under §172.24(b)(1) or 

§172.24(b)(2) for any of the following: 

(i) A product containing an active or 

inert ingredient not contained in any 

EPA-registered product; 

(ii) A product containing an active or 

inert ingredient which is currently subject to an EPA cancellation or suspension of registration order, or which is 

currently subject to an EPA notice of 

intent to suspend or cancel registration because of human health, environmental or efficacy considerations; except that the State may issue a permit 

for such a product for a purpose or in a 

formulation— 

(A) Which was not specifically considered in, or which is not subject to, 

such suspension or cancellation proceedings, after consultation with appropriate EPA officials; or 

(B) Which was specifically considered 

during such proceedings but not suspended, cancelled, or subjected to a notice of intent to suspend or cancel; 


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§ 172.25 40 CFR Ch. I (7–1–13 Edition) 

(iii) A use of a product which has 

been the subject of a notice of denial of 

registration published in the FEDERAL

REGISTER pursuant to section 3(c)(6) of 

FIFRA and part 154 of this chapter; or 

(iv) A use of a product which may involve use in or on food or feed other 

than as authorized under §172.24(d), Requirement of tolerance. 

(3) A State may not issue an experimental use permit for use of a pesticide 

product in an area or in an amount in 

excess of that necessary to accomplish 

the purposes for which the permit was 

issued under paragraph (b) of this section. 

(d) Requirement of tolerance. If the experimental use pesticide is to be used 

in or on food or feed, the applicant 

must— 

(1) Submit evidence that: 

(i) A tolerance or exemption from the 

requirement of a tolerance has been established for residues of the pesticide 

in or on such food or feed under section 

408 of the Federal Food, Drug and Cosmetic Act; and 

(ii) The proposed program would not 

reasonably be expected to result in residues of the pesticide in or on such food 

or feed in excess of that authorized 

under section 408 of the Federal Food, 

Drug and Cosmetic Act; and 

(iii) All inert ingredients in the pesticide are exempted from the requirement of a tolerance under the appropriate section of 40 CFR part 180, subpart D; or 

(2) Certify that the food or feed derived from the experimental program 

will be destroyed or fed only to experimental animals for testing purposes, or 

otherwise disposed of in a manner 

which will not endanger man or the environment. The method of destruction 

or disposal shall be described in the application for the permit. 

[44 FR 41787, July 18, 1979, as amended at 50 

FR 49020, Nov. 27, 1985; 73 FR 75599, Dec. 12, 

2008] 

§ 172.25 Administration of State programs. 

(a) General. State experimental use 

permit programs shall be consistent 

with the Federal experimental use permit program, as set forth in subpart A 

of 40 CFR part 172. 

(b) Procedures leading to issuance. An 

application for an experimental use 

permit shall be made in writing, and 

shall contain sufficient information, 

including a confidential statement of 

formula for any new product, to enable 

the State to determine whether use 

pursuant to the permit would be in accordance with the purposes of FIFRA 

and this subpart. 

(c) Labeling. (1) New products shall 

bear labeling satisfying the requirements of §172.6(a), except that the 

prominent statement ‘‘For Distribution and Experimental Use Only Within 

(State)’’ shall be used in place of ‘‘For 

Experimental Use Only’’. The designated State agency may approve, as 

directions for use on labeling, the experimental program, provided such program is to be distributed with the product. 

(2) The designated State agency may 

permit an EPA or State registered pesticide to be used under an experimental 

use permit with supplemental labeling 

as approved by the State agency. In exercising this discretion, the designated 

State agency shall ensure that the supplemental labeling and the registered 

label together satisfy the requirements 

of §172.6(a). 

(d) Duration. State experimental use 

permits shall be issued for a specified 

period of time, not to exceed three 

years, depending upon the nature of 

the pest problem and the requirements 

of the testing program submitted. The 

designated State agency may renew, 

extend or amend the stated duration of 

a permit, if circumstances warrant. 

(e) Limitations. The designated State 

agency shall impose such limitations 

in the permit as are necessary to protect health and the environment, including limitations on quantity, sites, 

area, disposal, and other aspects of pesticide use. 

(f) Program surveillance and reporting 

of data. (1) The permittee shall supervise the test program and evaluate the 

results of testing at each site of application. The designated State agency 

shall require the permittee to report to 

it immediately any adverse effects resulting from use of, or exposure to, the 

pesticide. 


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Environmental Protection Agency § 172.26 

(2) During the course of the program, 

the designated State agency shall require the permittee to submit such reports (both special and periodic) as are 

necessary to supervise effectively the 

progress of the program to prevent unreasonable adverse effects on man or 

the environment. The designated State 

agency shall also require the permittee 

to submit a final report at the conclusion of the program. Where applicable, 

such reports shall also be made available to the U.S. Department of Agriculture, Food Service and Quality 

Service (FSQS), as required by 

§172.8(c). 

(g) Disposal. All pesticides and pesticide containers, whether disposed of 

during the course of a State permit or 

remaining at the termination of a permit, must either be: 

(1) Disposed of in accordance with a 

disposal plan approved as part of the 

experimental program; or 

(2) Returned to the permittee for 

storage or disposal in accordance with 

the requirements of RCRA and rules 

there under; or 

(3) If the product is currently registered, used in accordance with the 

registered label. 

[44 FR 41787, July 18, 1979, as amended at 60 

FR 32097, June 19, 1995] 

§ 172.26 EPA review of permits. 

(a) Notification of State action. (1) 

Within 10 days after the issuance of an 

experimental use permit, the designated State agency shall notifiy EPA 

of the action by forwarding to the appropriate EPA Regional Office a copy 

of the permit, a description of the experimental program to be conducted 

under the terms of the permit, a copy 

of the approved labeling, and a copy of 

the confidential statement of formula 

for any new product. 

(2) Within 10 days after amendment 

or revocation of an experimental use 

permit by a State, the designated State 

agency shall notify the appropriate 

EPA Regional Office in writing of the 

amendment or revocation. The notice 

shall include a brief explanation of the 

reason for the amendment or revocation. If amendments to permits include 

changes in the approved labeling, the 

designated State agency shall also forward a copy of the amended labeling. 

(3) EPA shall give notice in the FEDERAL REGISTER of State issuance of experimental use permits. 

(b) Reports. The designated State 

agency shall submit the following reports to EPA: 

(1) An annual report covering the 

number of permits issued, the names 

and addresses of permittees, the names 

of the products covered by permits, and 

the State permit numbers issued; 

(2) Reports, as requested by EPA, 

containing any information that EPA 

may determine necessary to ensure 

that a State has acted in compliance 

with provisions of FIFRA and this subpart; and 

(3) Reports of any serious adverse effect(s), as soon thereafter as possible, 

from use of, or exposure to, a pesticide 

used pursuant to an experimental use 

permit. 

(c) Revocation by EPA. (1) The Administrator may revoke an experimental 

use permit issued under this subpart if 

he finds: 

(i) That its terms and conditions are 

being violated; 

(ii) That its terms and conditions are 

inadequate to avoid unreasonable adverse effects on the environment; 

(iii) That new evidence demonstrates 

that any tolerance upon which the permit is based will be inadequate to protect the public health, or that any exemption from the requirement for a 

tolerance is no longer appropriate; or 

(iv) That a failure by the permittee 

to meet any other provisions of FIFRA 

or this subpart has occurred. 

(2) The Administrator shall, prior to 

revoking a State experimental use permit, consult with the State agency 

which issued the permit, except in 

cases where continued use of the pesticide under the permit would create 

an imminent hazard to man or the environment. 

(3) The Administrator shall notify 

the designated State agency, in writing, of the revocation, and the State 

agency shall notify the permittee, also 

in writing, of the revocation. 

(4) The permittee shall notify all participants of the revocation within 10 

days after he receives notice of revocation. 

(5) The revocation of a permit shall 

not preclude the Administrator from 


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§ 172.43 40 CFR Ch. I (7–1–13 Edition) 

initiating civil or criminal sanctions 

for violations of the permit conditions 

or other violations, as authorized by 

law. 

(6) If a permittee wishes to contest 

the revocation of a State experimental 

use permit, he shall, within 30 days 

after receipt of notice of such revocation, file with the Administrator a 

written request for an opportunity to 

confer with the Administrator or his 

designee. The revocation of the permit 

shall remain effective pending the outcome of any conference requested 

under this paragraph. 

(7) If a permittee requests a conference under paragraph (c)(6) of this 

section, the Administrator shall provide the permittee: 

(i) With information as to the time, 

place and nature of the conference, and 

of the matters of fact and law asserted 

by the Agency as grounds for the revocation action; 

(ii) An opportunity to offer a written 

statement of facts, explanations, and 

arguments relevant to the revocation 

action; 

(iii) All other procedural opportunities to which the permittee may be entitled by law. 

(8) The Administrator shall notify 

the affected permittee and State Agency, in writing, of his final decision on 

the revocation matter as expeditiously 

as possible and shall attempt to do so 

within 30 days after the conclusion of a 

conference conducted under paragraph 

(c)(7). The Administrator shall also 

provide the permittee and the State 

agency with a written statement of the 

reasons for his decision, which shall 

take into account the evidence presented pursuant to paragraph (c)(7)(ii) 

of this section. 

(9) A decision to revoke a permit 

under paragraph (c)(8) of this section is 

a final Agency action subject to judicial review as provided by law. 

[44 FR 41787, July 18, 1979, as amended at 73 

FR 75599, Dec. 12, 2008] 

Subpart C—Notification for Certain 

Genetically Modified Microbial Pesticides 

SOURCE: 59 FR 45612, Sept. 1, 1994, unless 

otherwise noted. 

§ 172.43 Definitions. 

Terms used in this subpart shall, 

with the exception of those defined 

below, have the meaning set forth in 

the Act and in §172.1. 

Containment and inactivation controls 

means any combination of mechanical, 

procedural, or biological controls designed and operated to restrict environmental release of viable microorganisms from a facility. 

Deliberately modified means the directed addition, rearrangement, or removal of nucleotide sequences to or 

from genetic material. 

Introduction of genetic material means 

the movement of nucleotide sequences 

into a microorganism, regardless of the 

technique used. 

Inversions of genetic material means 

the replacement of an internal section 

of a chromosome in the reverse orientation. 

Microbial pesticide means a microbial 

agent intended for preventing, destroying, repelling, or mitigating any pest, 

or intended for use as a plant regulator, defoliant, or desiccant, that: 

(1) Is a eucaryotic microorganism including, but not limited to, protozoa, 

algae and fungi; 

(2) Is a procaryotic microorganism, 

including, but not limited to, 

Eubacteria and Archaebacteria; or 

(3) Is a parasitically replicating microscopic element, including, but not 

limited to, viruses. 

Microbial pesticides resulting from rearrangements means a microbial pesticide resulting from translocations or 

inversions of genetic material. 

Microorganism means a bacterium, 

fungus, alga, virus, or protozoan. 

Nonindigenous microbial pesticide 

means a microbial pesticide brought 

into one of the following geographic 

areas from outside that area: 

(1) The continental United States, including Alaska, and the immediately 

adjoining countries (i.e., Canada and 

Mexico). 

(2) The Hawaiian Islands. 

(3) The Caribbean Islands including 

Puerto Rico and the U.S. Virgin Islands. 


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Environmental Protection Agency § 172.45 

Pesticidal property means a characteristic exhibited by a microorganism that contributes to the intentional use of the microorganism to prevent, destroy, repel, or mitigate a pest 

or to act as a plant regulator, defoliant, or desiccant. 

Single genome means the sum total of 

chromosomal and extrachromosomal 

genetic material of an isolate and any 

descendants derived under axenic culture conditions from that isolate. 

Small-scale test means the experimental use of a microbial pesticide in a 

facility such as a laboratory or greenhouse, or use in limited replicated field 

trials or other tests as described in 

§172.3(c). 

Test or testing means any use of a microbial pesticide consistent with section 5 of the Act, including limited replicated field trials and associated activities. 

Translocations of genetic material 

means a chromosomal configuration in 

which part of a chromosome becomes 

attached to a different chromosome, or 

inserts in a different location on the 

same chromosome. 

[59 FR 45612, Sept. 1, 1994, as amended at 72 

FR 61029, Oct. 26, 2007] 

§ 172.45 Requirement for a notification. 

(a) Who must submit a Notification. 

Notwithstanding §172.3, any person 

who plans to conduct small-scale testing of a type of microbial pesticide 

identified in paragraph (c) of this section must submit a Notification to 

EPA and obtain prior approval for either of the following tests: 

(1) Small-scale tests that involve an 

intentional environmental introduction of that microbial pesticide. 

(2) Small-scale tests performed in a 

facility without adequate containment 

and inactivation controls as provided 

in paragraph (e) of this section. 

(b) Alternative to Notification. In lieu 

of a Notification, any person required 

to submit a Notification under paragraph (a) of this section may submit an 

application for an experimental use 

permit (EUP) to EPA for approval. 

(c) Small-scale testing that requires a 

Notification. As provided in paragraph 

(a) of this section, and notwithstanding 

any other approval by any governmental entity, EPA review and approval are required prior to the initiation of any small-scale test involving 

either of the following microbial pesticides: 

(1) Microbial pesticides whose pesticidal properties have been imparted 

or enhanced by the introduction of genetic material that has been deliberately modified. 

(2) Nonindigenous microbial pesticides that have not been acted upon 

by the U.S. Department of Agriculture 

(i.e., either by issuing or denying a permit or determining that a permit is unnecessary; or a permit is not pending 

with the USDA). 

(d) Small-scale testing that does not require a Notification. (1) Testing conducted with microbial pesticides identified in paragraph (c) of this section, 

but made exempt pursuant to §172.52, 

does not require a Notification. The 

following microbial pesticides (or 

classes of pesticides) are exempt from 

the notification requirement in paragraph (a) of this section: 

(i) Microbial pesticides resulting 

from deletions or rearrangements within a single genome that are brought 

about by the introduction of genetic 

material that has been deliberately 

modified. 

(ii) [Reserved] 

(2) Testing conducted in a facility 

with adequate containment and inactivation controls, as provided in paragraph (e) of this section, does not require a Notification. 

(e) Selection and use of containment 

and inactivation controls. (1) Selection 

and use of containment and inactivation controls for a particular microbial 

pesticide shall take into account the 

following: 

(i) Factors relevant to the microbial 

pesticide’s ability to survive in the environment. 

(ii) Potential routes of release in air, 

solids, and liquids; in or on waste materials and equipment; in or on people 

(including maintenance and custodial 

personnel); and in or on other organisms such as insects and rodents. 

(iii) Procedures for transfer of materials between facilities. 

(iv) Plans for routine or emergency 

clean-up and test termination. 


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§ 172.46 40 CFR Ch. I (7–1–13 Edition) 

(2) For purposes of paragraph (e)(1) of 

this section, EPA will presume that 

compliance with the containment provisions of the National Institutes of 

Health (NIH) ‘‘Guidelines for Research 

Involving Recombinant DNA Molecules’’ (51 FR 16958, May 7, 1986) constitutes selection and use of adequate 

containment and inactivation controls. 

(3) The selection of containment and 

inactivation controls shall be approved 

by an authorized official of the organization that is conducting the test prior 

to commencement of the test. 

(4) Records shall be developed and 

maintained describing the selection 

and use of the containment and inactivation controls, including contingency plans for emergency clean-up 

and test termination, that will be used 

during the test. These records shall be 

available for inspection at the test facility. In addition, these records shall 

be submitted to EPA at EPA’s request 

and within the time frame specified in 

EPA’s request. 

(5) Subsequent to any EPA review of 

the containment/inactivation controls 

selected under paragraph (e)(1) of this 

section, changes to the controls necessary to prevent unreasonable adverse 

effects must be made upon EPA request. Failure to comply with EPA’s 

request shall result in automatic revocation of the exemption from the requirement to submit a Notification. 

§ 172.46 Submission of a notification. 

(a) When to submit a Notification. A 

Notification shall be submitted for approval at least 90 days prior to the initiation of the proposed test. 

(b) Where to submit a notification. A 

notification shall be 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), Attention: Biotechnology Notification Review. 

(c) How to format a Notification. A Notification submitted under this section 

must comply with the following procedures, but is not required to comply 

with the format and other provisions 

governing submission of data in 

§§158.32 and 158.33 or §§161.32 and 161.33 

of this chapter. However, because data 

submitted with the Notification may 

subsequently be used to support other 

regulatory actions (e.g., used in EUP or 

registration applications), it is recommended that such data comply with 

EPA requirements in §§158.32 and 158.33 

of this chapter. 

(1) Each Notification must be accompanied by a transmittal document that 

clearly identifies the EPA action supported as a Biotechnology Notification 

Review. 

(2) Five copies of each Notification 

must be submitted to EPA. 

(3) Any claims of confidentiality for 

information submitted in the Notification must be made as described in paragraph (d) of this section. 

(d) How to make confidential business 

information (CBI) claims in a Notification. Although it is strongly recommended that the submitter minimize the amount of data and other information claimed as CBI, a submitter 

may assert a claim of confidentiality 

for all or part of the information submitted to EPA in a Notification (See 

part 2, subpart B of this chapter). To 

assert such a claim, the submitter 

must comply with the following procedures: 

(1) Any claim of confidentiality must 

accompany the information at the time 

the information is submitted to EPA. 

Failure to assert a claim at that time 

will be considered a waiver of confidentiality for the information submitted, 

and the information may be made 

available to the public, subject to section 10(g) of the Act, with no further 

notice to the submitter. 

(2) Of the five copies of the Notification required by paragraph (c) of this 

section, four copies must be complete 

with the information that is claimed 

confidential clearly marked in the 

manner described in §2.203(b) of this 

chapter. All information claimed as 

confidential must be deleted from the 

fifth copy, but it must be otherwise 

complete. The first page of the fifth 

copy must be marked ‘‘Contains no information claimed as confidential.’’ 

EPA may include the fifth copy in a 

public file without further notice. EPA 

will consider incomplete a Notification 

containing information claimed as CBI 

that is not submitted in accordance 

with this paragraph and will suspend 

the review period on the Notification 

until such procedures are followed. 


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Environmental Protection Agency § 172.48 

(3) Any claim of confidentiality must 

be accompanied, at the time the claim 

is made, by comments substantiating 

the claim and explaining why the submitter believes that the information 

should not be disclosed. The submitter 

should refer to §2.204(e)(4) of this chapter for points to address in the substantiation. If such comments are themselves claimed confidential and are 

marked confidential when submitted to 

EPA, they will be treated as such in accordance with §2.205(c) of this chapter. 

EPA will consider incomplete all Notifications containing information 

claimed as CBI that are not accompanied by substantiation, and will suspend the review period on such Notifications until the required substantiation is provided. 

(4) EPA will disclose information 

that is subject to a claim of confidentiality asserted under this section only 

to the extent and by means of the procedures set forth in section 10 of the 

Act, in this subpart, and in part 2 of 

this chapter. 

[59 FR 45612, Sept. 1, 1994, as amended at 71 

FR 35546, June 21, 2006; 72 FR 61029, Oct. 26, 

2007; 73 FR 75600, Dec. 12, 2008] 

§ 172.48 Data requirements for a notification. 

This section identifies the data and 

information to be included in each Notification. When specific information is 

not submitted, an explanation of why 

it is not practical or necessary to provide the information is to be provided. 

(a) The identity of the microorganism which constitutes the microbial 

pesticide including: 

(1) Summary of data supporting the 

taxonomic designation and its interpretation. 

(2) Means and limit of detection 

using sensitive and specific methods 

(e.g., note the use of any markers that 

are used to distinguish the introduced 

population from native microorganisms). Introduction into the microbial 

pesticide of a unique genetic marker is 

encouraged. 

(b) Description of the natural habitat 

of the parental strain of the microbial 

pesticide including information on: 

(1) Physical and chemical features 

important to growth and survival of 

the parental strain. 

(2) Biological features of the parental 

strain that would have an impact on 

the microbial pesticide (e.g., presence 

of phages that infect the microorganism). 

(3) Competitors. 

(c) Information on the host range of 

the microbial pesticide, if any, with an 

assessment of infectivity and pathogenicity to nontarget organisms. 

(d) Information on survival and the 

ability of the microbial pesticide to increase in numbers (biomass) in the environment (e.g., in the environment 

into which the microbial pesticide will 

be introduced, and in substantially different environments that may be in the 

immediate vicinity). These data may 

be derived from the scientific literature or from tests conducted in a 

laboratory or other containment facility. 

(e) The identity of possible transmission vectors (e.g., insects). 

(f) Data on relative environmental 

competitiveness compared to the parental strain of the microbial pesticide. 

(g) Description of the methods used 

to genetically modify the microbial 

pesticide. 

(h) The identity and location of the 

gene segments that have been rearranged or inserted/deleted (host source, 

nature, and, for example, base sequence 

data, or restriction enzyme map of the 

genes). 

(i) Information on the control region 

of the genes, and a description of the 

new traits or characteristics that are 

expressed. 

(j) Data on potential for genetic 

transfer and exchange with other organisms and on genetic stability of any 

inserted sequences in the microbial 

pesticide. 

(k) A description of the proposed 

testing program including: 

(1) The purpose or objectives of the 

proposed testing. 

(2) Designation of the pest organisms 

involved (common and scientific 

names). 

(3) The States in which the proposed 

program will be conducted. 

(4) The exact location of the test 

sites (including proximity to residences and human activities, surface 

water, etc.). 


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§ 172.50 40 CFR Ch. I (7–1–13 Edition) 

(5) The crops, fauna, flora, geographical description of sites, modes, 

dosage rates, frequency, and situation 

of application on or in which the pesticide is to be used. 

(6) The total amount of pesticide 

product proposed for use in the testing. 

(7) The method of application. 

(8) A comparison of the natural habitat of the microbial pesticide with the 

proposed test site. 

(9) The number of acres, structural 

sites, or animals/plants by State, to be 

treated or included in the area of experimental use. 

(10) Procedures to be used to protect 

the test area from intrusion by unauthorized individuals. 

(11) The proposed dates or periods 

during which the testing program is to 

be conducted, and the manner in which 

supervision of the program will be accomplished. 

(12) Description of procedures for 

monitoring the microbial pesticide 

within and adjacent to the test site 

during the test. 

(13) The method of sanitation or disposal of plants, animals, soils, farm 

tools, machinery etc., that will be exposed to the microbial pesticide during 

or after the test. 

(14) Means of evaluating potential adverse effects and methods of controlling the microbial pesticide if detected 

beyond the test area. 

(l) A statement of composition for 

the formulation to be tested, giving: 

(1) The name and percentage by 

weight (or other suitable units) of each 

ingredient, active and inert. 

(2) Production methods. 

(3) Extraneous microorganisms 

present as contaminants. 

(4) Amount and potency of any toxin 

present. 

(5) Where applicable, the number of 

viable microorganisms per unit weight 

or volume of the product or other appropriate system for designating the 

quantity of active ingredient. 

(m) Any additional factual information regarding the potential for unreasonable adverse effects on the environment. 

§ 172.50 Response to a notification. 

(a) EPA will review and evaluate 

each Notification as expeditiously as 

possible and will make a determination 

no later than 90 days after receipt of 

the complete Notification; however, 

under no circumstances shall the proposed test proceed until the submitter 

has received notice from EPA of its approval of such test. 

(b) For each Notification, EPA may 

make the following determinations: 

(1) Require additional information 

from the submitter to assess the proposed test adequately. 

(2) Approve the proposed test. 

(3) Approve the proposed test provided that the submitter makes certain 

modifications to the test proposal. 

(4) Require an EUP for the test. 

(5) Disapprove the proposed test because of the potential for unreasonable 

adverse effects. Such disapproval by 

EPA shall be considered the equivalent 

of denial of an EUP and the remedies 

for such denial provided by §172.10 are 

available to the submitter. 

(c) If the proposed test is approved by 

EPA, then the submitter shall perform 

the test in the same manner described 

in the Notification, subject to any requirements imposed under paragraph 

(b)(3) of this section. 

§ 172.52 Notification exemption process. 

(a) Initiation of the exemption process. 

Pesticides may be added to the list of 

exemptions in §172.45(d) by rule at 

EPA’s initiative or in response to a petition submitted in accordance with 

paragraph (b) of this section. 

(b) Petitions for exemption from the requirement for a Notification—(1) Who 

may submit a petition. Any person may 

submit a petition requesting an exemption from the notification requirements of this subpart for a specific microbial pesticide or class of microbial 

pesticides. 

(2) Where to submit a petition. All petitions shall be 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). 

(3) Content of petition. Each petition 

shall contain the following: 

(i) Name and address of petitioner 

and name, address, and telephone number of a person who may be contacted 

for further information. 


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Environmental Protection Agency § 172.59 

(ii) Description of the exemption requested, including the specific microbial pesticide or class of microbial pesticides to be tested under the petition 

for exemption. 

(iii) Basis for the petitioner’s contention that the specific microbial pesticide or class of microbial pesticides 

meet the criteria of §172.3 for smallscale tests of pesticides that do not require an EUP. 

(iv) Discussion of the extent to which 

the microbial pesticide or class of microbial pesticides covered by the petition differ from microbial pesticides 

that are already registered or subject 

to an EUP under the Act. 

(4) Administrative action on a petition. 

EPA will review and evaluate petitions 

as expeditiously as possible and may 

request further information from the 

petitioner to assess the proposed exemption adequately. No later than 180 

days after the submission of a petition, 

or 90 days after the last submission of 

additional information by the petitioner, whichever is later, EPA will 

take one of the following actions with 

respect to the petition: 

(i) Grant the petition and publish a 

notice of proposed rulemaking in the 

FEDERAL REGISTER for a 45–day comment period proposing the exemption 

requested by the petitioner. 

(ii) Grant the petition and publish a 

notice of proposed rulemaking in the 

FEDERAL REGISTER for a 45–day comment period proposing an exemption 

under such terms and conditions as 

EPA deems appropriate. 

(iii) Deny the petition and provide 

the petitioner with a written explanation of EPA’s decision. 

(5) Confidential business information 

(CBI) claims. To assert a claim of confidentiality, the petitioner must comply with the applicable procedures in 

§172.46(d). 

(6) Supplements, amendments, and 

withdrawals. The petitioner may supplement, amend, or withdraw his or her 

petition in writing without EPA approval at any time prior to the granting or denial of the petition under 

paragraph (b)(4) of this section. The 

withdrawal of a petition shall be without prejudice to the resubmission of 

the petition at a later date. 

[59 FR 45612, Sept. 1, 1994, as amended at 71 

FR 35546, June 21, 2006] 

§ 172.57 Submission of information regarding potential unreasonable adverse effects. 

Any person using a microbial pesticide in small-scale testing covered by 

this subpart who obtains information 

regarding potential unreasonable adverse effects on health or the environment must within 30 days of receipt of 

such information submit the information to EPA, unless the person has actual knowledge that EPA has been adequately informed of such information. 

The requirement to submit information applies both to those microbial 

pesticides subject to the notification 

requirements under §172.45(c) and those 

that are exempt under §172.45(d). 

§ 172.59 Enforcement. 

(a) Imminent threat of substantial harm 

to health or the environment. The use of 

a microbial pesticide in small-scale 

testing covered by this subpart (whether subject to the notification requirements of §172.45(c) or exempt under 

§172.45(d)) in a manner that creates an 

imminent threat of substantial harm 

to health or the environment is prohibited, and is considered a violation of 

section 12(a)(2)(S) of the Act. 

(b) EPA response to violations. Under 

section 14 of the Act, EPA may seek 

civil or criminal penalties for violations of the Act. Failure to comply 

with the regulations in this part could 

result in civil or criminal penalties. 

Moreover, under sections 14 and 16(c) of 

the Act, EPA may at any time take appropriate action against violators to 

prevent or otherwise restrain use of a 

microbial pesticide in small-scale testing if it is determined that: 

(1) Such use would create an imminent threat of substantial harm to 

health or the environment that is prohibited under paragraph (a) of this section; or 

(2) The terms or conditions on which 

approval of the testing was granted 

under this subpart C are violated. 


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