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Environmental Protection Agency Pt. 174 

(d) If a termination order is issued or 

the hearing is rescheduled after the notice of intent to rescind is published in 

the FEDERAL REGISTER, such order or 

notice rescheduling the hearing shall 

also be published in the FEDERAL REGISTER. 

§ 173.7 Hearing and recommended decision. 

(a) The Presiding Officer shall: 

(1) Conduct a fair and impartial hearing, without unnecessary delay; 

(2) Ensure that the facts are fully 

elicited; and 

(3) Consider all evidence, comment, 

and argument which is submitted by 

persons who will be affected by the outcome of the proceeding and which is 

not irrelevant, immaterial, unduly repetitious, or otherwise unreliable or of 

little probative value. The Presiding 

Officer may require any prospective 

witness to make available, in advance 

of the hearing, a brief summary of his 

or her testimony. 

(b) If, following the close of the hearing, the Presiding Officer finds that the 

State has corrected, or has agreed in 

writing to correct, the deficiencies 

specified in the notice of intent to rescind or has shown that such deficiencies do not exist, the Presiding Officer shall issue a decision recommending that the notice of intent to 

rescind be withdrawn and that the rescission proceeding be terminated. 

(c) If, following the close of the hearing, the Presiding Officer finds that the 

State has not corrected the deficiencies in its program, the Presiding 

Officer shall issue a decision recommending that the State’s primary enforcement responsibility for pesticide 

use violations be rescinded in whole or 

in part. 

(d) The recommended decision of the 

Presiding Officer shall become final 

Agency action forty-five (45) days after 

its service upon the parties and without further proceedings unless (1) an 

appeal to the Administrator is taken 

from it by a party to the proceeding, or 

(2) the Administrator elects, sua 

sponte, to review the recommended decision. 

§ 173.8 Final order. 

(a) If the State does not request a 

hearing within the sixty-day time period and the Administrator has not 

issued an order withdrawing the notice 

of intent to rescind, the Administrator 

shall issue a final order as soon as 

practicable after the time for public 

comment on the notice of intent to rescind has elapsed. The final order shall 

either withdraw the notice of intent to 

rescind and terminate the proceeding 

or rescind, in whole or in part, the 

State’s primary enforcement responsibility for pesticide use violations. 

(b) If a hearing has been held and the 

Presiding Officer has made a recommended decision, then either the Office of Enforcement or the State may 

appeal the recommended decision to 

the Administrator or the Administrator may elect to review the recommended decision on his own initiative. 

(c) After an appeal or sua sponte review the Administrator shall issue a 

final order terminating the rescission 

proceeding or rescinding, in whole or in 

part, the State’s primary enforcement 

responsibility for pesticide use violations. 

(d) In no event may the Administrator issue his final decision sooner 

than ninety (90) days after service of 

the notice of intent to rescind on a 

State. 

(e) Any final order, or a recommended decision which becomes a 

final order under §173.7(c), shall be published in the FEDERAL REGISTER. 

§ 173.9 Judicial review. 

The State may appeal an order rescinding, in whole or in part, its primary enforcement responsibility for 

pesticide use violations to the appropriate federal court pursuant to section 

16 of FIFRA. 

PART 174—PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED PROTECTANTS 

Subpart A—General Provisions 

Sec. 

174.1 Scope and purpose. 

174.3 Definitions. 


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§ 174.1 40 CFR Ch. I (7–1–06 Edition) 

174.9 Confidential business information 

claims for plant-incorporated protectant 

submissions. 

Subpart B—Exemptions 

174.21 General qualifications for exemptions. 

174.25 Plant-incorporated protectant from 

sexually compatible plant. 

Subpart C—Registration Procedures and 

Requirements [Reserved] 

Subpart D—Monitoring and Recordkeeping 

174.71 Submission of information regarding 

adverse effects. 

Subparts E–F [Reserved] 

Subpart G—Labeling Requirements 

[Reserved] 

Subpart H—Data Requirements [Reserved] 

Subpart I [Reserved] 

Subpart J—Good Laboratory Practices 

[Reserved] 

Subpart K—Export Requirements 

[Reserved] 

Subparts L–T [Reserved] 

Subpart U—Experimental Use Permits 

[Reserved] 

Subpart V [Reserved] 

Subpart W—Tolerances and Tolerance 

Exemptions 

174.451 Scope and purpose. 

174.452 Bacillus thuringiensis VIP3A protein 

and the genetic material necessary for 

its production; temporary exemption 

from the requirement of a tolerance. 

174.455 Bacillus thuringiensis Cry1F protein 

and the genetic material necessary for 

its production in cotton; exemption from 

the requirement of a tolerance. 

174.456 Bacillus thuringiensis modified 

Cry3A protein (mCry3A) and the genetic 

material necessary for its production in 

corn. 

174.457 Bacillus thuringiensis Cry34Ab1 and 

Cry35Ab1 proteins and the genetic material necessary for their production in 

corn; exemption from the requirement of 

a tolerance. 

174.475 Nucleic acids that are part of a 

plant-incorporated protectant; exemption from the requirement of a tolerance. 

174.479 Pesticidal substance from sexually 

compatible plant; exemption from the requirement of a tolerance. 

Subparts X—List of Approved Inert 

Ingredients 

174.480 Scope and purpose. 

174.485 Inert ingredients from sexually compatible plant. 

Subparts Y–Z [Reserved] 

AUTHORITY: 7 U.S.C. 136–136y; 21 U.S.C. 346a 

and 371. 

SOURCE: 66 FR 37814, July 19, 2001, unless 

otherwise noted. 

Subpart A—General Provisions 

§ 174.1 Scope and purpose. 

The characteristics of plant-incorporated protectants such as their production and use in plants, their biological properties, and their ability to 

spread and increase in quantity in the 

environment distinguish them from 

traditional chemical pesticides. Therefore, plant-incorporated protectants 

are subject to some different regulatory requirements and procedures 

than traditional chemical pesticides. 

This part sets forth regulatory requirements, criteria, and procedures applicable to plant-incorporated protectants 

under FIFRA and FFDCA. When applied to plant-incorporated 

protectants, the definitions and regulations in this part supercede the regulations found in parts 150 through 180 of 

this chapter to the extent that the regulations conflict. Unless otherwise 

superceded by this part, the regulations in parts 150 through 180 of this 

chapter apply to plant-incorporated 

protectants. 

§ 174.3 Definitions. 

Terms used in this part have the 

same meaning as in FIFRA. In addition, the following terms have the 

meaning set forth in this section. 

Active ingredient means a pesticidal 

substance that is intended to be produced and used in a living plant, or in 

the produce thereof, and the genetic 

material necessary for the production 

of such a pesticidal substance. 


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Environmental Protection Agency § 174.3 

Administrator means the Administrator of the United States Environmental Protection Agency or his/her 

delegate. 

Bridging crosses between plants means 

the utilization of an intermediate plant 

in a cross to produce a viable zygote 

between the intermediate plant and a 

first plant, in order to cross the plant 

resulting from that zygote with a third 

plant that would not otherwise be able 

to produce viable zygotes from the fusion of its gametes with those of the 

first plant. The result of the bridging 

cross is the mixing of genetic material 

of the first and third plant through the 

formation of an intermediate zygote. 

Cell fusion means the fusion in vitro of 

two or more cells or protoplasts. 

Conventional breeding of plants means 

the creation of progeny through either: 

The union of gametes, i.e., syngamy, 

brought together through processes 

such as pollination, including bridging 

crosses between plants and wide 

crosses, or vegetative reproduction. It 

does not include use of any of the following technologies: Recombinant 

DNA; other techniques wherein the genetic material is extracted from an organism and introduced into the genome 

of the recipient plant through, for example, micro-injection, macro-injection, micro-encapsulation; or cell fusion. 

EPA means the United States Environmental Protection Agency. 

Exudate means a substance gradually 

discharged or secreted across intact 

cellular membranes or cell walls and 

present in the intercellular spaces or 

on the exterior surfaces of the plant. 

FFDCA means the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 321 

et seq.). 

FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act, 

as amended (7 U.S.C. 136 et seq.). 

Food includes articles used for food 

or drink by humans or other animals. 

Food plant means a plant which either in part or in toto, is used as food. 

Genetic material necessary for the production means both: Genetic material 

that encodes a substance or leads to 

the production of a substance; and regulatory regions. It does not include 

noncoding, nonexpressed nucleotide sequences. 

Genome means the sum of the heritable genetic material in the plant, including genetic material in the nucleus 

and organelles. 

In a living plant means inside the living plant, on the surface of the living 

plant, or as an exudate from the living 

plant. 

Inert ingredient, means any substance, 

such as a selectable marker, other than 

the active ingredient, where the substance is used to confirm or ensure the 

presence of the active ingredient, and 

includes the genetic material necessary for the production of the substance, provided that genetic material 

is intentionally introduced into a living plant in addition to the active ingredient. 

Living plant means a plant, plant 

organ, or plant part that is alive, viable, or dormant. Examples of plant 

parts include, but are not limited to, 

seeds, fruits, leaves, roots, stems, flowers, and pollen. 

Noncoding, nonexpressed nucleotide sequences means the nucleotide sequences 

are not transcribed and are not involved in gene expression. Examples of 

noncoding, nonexpressed nucleotide sequences include, but are not limited to, 

linkers, adapters, homopolymers, and 

sequences of restriction enzyme recognition sites. 

Nucleic acids means ribosides or 

deoxyribosides of adenine, thymine, 

guanine, cytosine, and uracil; polymers 

of the deoxyribose-5′-monophosphates 

of thymine, cytosine, guanine, and adenine linked by successive 3′-5′ 

phosphodiester bonds (also known as 

deoxyribonucleic acid); and polymers 

of the ribose-5′-monophosphates of uracil, cytosine, guanine, and adenine 

linked by successive 3′-5′ 

phosphodiester bonds (also known as 

ribonucleic acid). The term does not 

apply to nucleic acid analogues (e.g., 

dideoxycytidine), or polymers containing nucleic acid analogues. 

Pesticidal substance, means a substance that is intended to be produced 

and used in a living plant, or in the 

produce thereof, for a pesticidal purpose, during any part of a plant’s life 

cyle (e.g., in the embryo, seed, seedling, mature plant). 


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§ 174.9 40 CFR Ch. I (7–1–06 Edition) 

Plant, for plant-incorporated 

protectants, means an organism classified using the 5-kingdom classification 

system of Whittaker in the kingdom 

Plantae. This includes, but is not limited to, bryophytes such as mosses, 

pteridophytes such as ferns, 

gymnosperms such as conifers, and 

angiosperms such as most major crop 

plants. 

Plant-incorporated protectant means a 

pesticidal substance that is intended to 

be produced and used in a living plant, 

or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance. It 

also includes any inert ingredient contained in the plant, or produce thereof. 

Produce thereof, when used with respect to plants containing plant- incorporated protectants only, means a 

product of a living plant containing a 

plant-incorporated protectant, where 

the pesticidal substance is intended to 

serve a pesticidal purpose after the 

product has been separated from the 

living plant. Examples of such products 

include, but are not limited to, agricultural produce, grains, and lumber. 

Products such as raw agricultural commodities bearing pesticide chemical 

residues are not ‘‘produce thereof’’ 

when the residues are not intended to 

serve a pesticidal purpose in the 

produce. 

Recipient plant means the living plant 

in which the plant-incorporated protectant is intended to be produced and 

used. 

Recombinant DNA means the genetic 

material has been manipulated in vitro 

through the use of restriction 

endonucleases and/or other enzymes 

that aid in modifying genetic material, 

and subsequently introduced into the 

genome of the plant. 

Regulatory region means genetic material that controls the expression of 

the genetic material that encodes a 

pesticidal substance or leads to the 

production of a pesticidal substance. 

Examples of regulatory regions include, but are not limited to, promoters, enhancers, and terminators. 

Sexually compatible, when referring to 

plants, means a viable zygote is formed 

only through the union of two gametes 

through conventional breeding. 

Source means the donor of the genetic 

material that encodes a pesticidal substance or leads to the production of a 

pesticidal substance. 

Vegetative reproduction means either: 

(1) In seed plants, reproduction by 

apomixis, or 

(2) In other plants, reproduction by 

fragmentation, or division of the somatic body. 

Wide crosses means to facilitate the 

formation of viable zygotes through 

the use of surgical alteration of the 

plant pistil, bud pollination, mentor 

pollen, immunosuppressants, in vitro 

fertilization, pre-pollination and postpollination hormone treatments, manipulation of chromosome numbers, 

embryo culture, or ovary and ovule 

cultures. 

§ 174.9 Confidential business information claims for plant-incorporated 

protectant submissions. 

Although it is strongly recommended 

that the submitter minimize the 

amount of data and other information 

claimed as Confidential Business Information (CBI), a submitter may assert a 

claim of confidentiality for all or part 

of the information submitted to EPA 

in a submission for a plant-incorporated protectant. (See part 2, subpart 

B of this chapter.) To assert such a 

claim, the submitter must comply with 

all of the following procedures: 

(a) 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 

constitutes a waiver of confidentiality 

for the nformation submitted, and the 

information may be made available to 

the public, subject to section 10(g) of 

FIFRA, with no further notice to the 

submitter. 

(b) 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 

must address each of the points listed 

in §2.204(e)(4) of this chapter in the 

substantiation. EPA will consider incomplete all plant-incorporated protectant submissions containing information claimed as CBI that are not accompanied by substantiation, and will 


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Environmental Protection Agency § 174.71 

suspend any applicable review of such 

submissions until the required substantiation is provided. 

Subpart B—Exemptions 

§ 174.21 General qualifications for exemptions. 

A plant-incorporated protectant is 

exempt from the requirements of 

FIFRA, other than the requirements of 

§174.71, if it meets all of the following 

criteria: 

(a) The plant-incorporated protectant 

meets the criteria listed in at least one 

of the sections in §§174.25 through 

174.50. 

(b) When the plant-incorporated protectant is intended to be produced and 

used in a crop used as food, the residues of the plant-incorporated protectant are either exempted from the requirement of a tolerance under FFDCA 

(as amended, 21 U.S.C. 321 et seq.) as 

codified at §§174.475 through 174.479, or 

no tolerance would otherwise be required for the plant-incorporated protectant. 

(c) Any inert ingredient that is part 

of the plant-incorporated protectant is 

on the list codified at §§174.485 through 

174.490. Plant-incorporated protectants 

that are not exempt from the requirements of FIFRA under this subpart are 

subject to all the requirements of 

FIFRA. 

§ 174.25 Plant-incorporated protectant 

from sexually compatible plant. 

A plant-incorporated protectant is 

exempt if all of the following conditions are met: 

(a) The genetic material that encodes 

the pesticidal substance or leads to the 

production of the pesticidal substance 

is from a plant that is sexually compatible with the recipient plant. 

(b) The genetic material has never 

been derived from a source that is not 

sexually compatible with the recipient 

plant. 

Subpart C—Registration Procedures and Requirements [Reserved] 

Subpart D—Monitoring and 

Recordkeeping 

§ 174.71 Submission of information regarding adverse effects. 

(a) Any person who produces, for sale 

or distribution, a plant-incorporated 

protectant exempt under subpart B of 

this part, who obtains any information 

regarding adverse effects on human 

health or the environment alleged to 

have been caused by the plant-incorporated protectant must submit such 

information to EPA. This requirement 

does not apply to any person who does 

not produce a plant-incorporated protectant exempt under supart B of this 

part. This may include, for example, 

researchers performing field experiments, breeders making crosses among 

plant varieties with the goal of developing new plant varieties, or a person 

who only sells propagative materials 

(e.g., seed) to farmers without producing the propagative materials 

themselves. EPA must receive the report within 30 calendar days of the date 

the producer first possesses or knows of 

the information. 

(b) Adverse effects on human health 

or the environment for purposes of 

plant-incorporated protectant means 

at a minimum information about incidents affecting humans or other nontarget organisms where both: 

(1) The producer is aware, or has been 

informed, that a person or nontarget 

organism allegedly suffered a toxic or 

adverse effect due to exposure to (e.g., 

ingestion of) a plant-incorporated protectant. 

(2) The producer has or could reasonably obtain information concerning 

where the incident occurred. 

(c) All of the following information, 

if available, must be included in a report. 

(1) Name of reporter, address, and 

telephone number. 

(2) Name, address, and telephone of 

contact person (if different than reporter). 

(3) Description of incident. 

(4) Date producer became aware of incident. 

(5) Date of incident. 

(6) Location of incident. 

(d) Reports and questions should be 

submitted to the Office of Pesticide 


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§ 174.451 40 CFR Ch. I (7–1–06 Edition) 

Programs’ Document Processing Desk 

at the appropriate address as set forth 

in 40 CFR 150.17(a) or (b). 

[66 FR 37814, July 19, 2001, as amended at 71 

FR 35546, June 21, 2006] 

Subparts E–F [Reserved] 

Subpart G—Labeling [Reserved] 

Subpart H—Data Requirements 

[Reserved] 

Subpart I [Reserved] 

Subpart J—Good Laboratory 

Practices [Reserved] 

Subpart K—Export Requirements 

[Reserved] 

Subparts L–T [Reserved] 

Subpart U—Experimental Use 

Permits [Reserved] 

Subpart V [Reserved] 

Subpart W—Tolerances and 

Tolerance Exemptions 

§ 174.451 Scope and purpose. 

This subpart lists the tolerances and 

exemptions from the requirement of a 

tolerance for residues of plant-incorporated protectants in or on raw agricultural commodities, in food, and in 

animal feeds. 

§ 174.452 Bacillus thuringiensis VIP3A 

protein and the genetic material 

necessary for its production; temporary exemption from the requirement of a tolerance. 

Bacillus thuringiensis VIP3A protein 

and the genetic material necessary for 

its production is temporarily exempt 

from the requirement of a tolerance 

when used as a vegetative-insecticidal 

protein in cotton seed, cotton oil, cotton meal, cotton hay, cotton hulls, cotton forage, and cotton gin byproducts. 

Genetic material necessary for its production means the genetic material 

which comprise genetic encoding the 

VIP3A protein and its regulatory regions. Regulatory regions are the genetic material, such as promoters, terminators, and enhancers, that control 

expression of the genetic material encoding the VIP3A protein. This temporary exemption from the requirement of a tolerance expires May 1, 2007. 

[71 FR 24586, Apr. 26, 2006] 

§ 174.455 Bacillus thuringiensis Cry1F 

protein and the genetic material 

necessary for its production in cotton; exemption from the requirement of a tolerance. 

Bacillus thuringiensis Cry1F protein 

and the genetic material necessary for 

its production in cotton are exempt 

from the requirement of a tolerance 

when used as a plant-incorporated protectant in food and feed commodities 

of cotton. ‘‘Genetic material necessary 

for its production’’ means the genetic 

material which comprise: Genetic material encoding the Cry1F protein and 

its regulatory regions. ‘‘Regulatory regions’’ are the genetic material, such 

as promoters, terminators, and 

enhancers, that control the expression 

of the genetic material encoding the 

Cry1F protein. 

[69 FR 58284, Sept. 30, 2004] 

§ 174.456 Bacillus thuringiensis modified Cry3A protein (mCry3A) and 

the genetic material necessary for 

its production in corn. 

Bacillus thuringiensis modified Cry3A 

protein (mCry3A) and the genetic material necessary for its production in 

corn is temporarily exempt from the 

requirement of a tolerance when used 

as plant-incorporated protectant in the 

food and feed commodities of field 

corn, sweet corn and popcorn. Genetic 

material necessary for its production 

means the genetic material which comprise genetic material encoding the 

mCry3A protein and its regulatory regions. Regulatory regions are the genetic material, such as promoters, terminators, and enhancers, that control 

the expression of the genetic material 

encoding the mCry3A protein. This 

temporary exemption from the requirement of a tolerance will permit the use 

of the food commodities in this paragraph when treated in accordance with 

the provisions of the experimental use 

permit 67979–EUP–4 which is being 


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Environmental Protection Agency Pt. 176 

issued under the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA), as amended (7 U.S.C. 136). 

This temporary exemption from the requirement of a tolerance expires and is 

revoked October 15, 2007; however, if 

the experimental use permit is revoked, or if any experience with or scientific data on this pesticide indicate 

that the tolerance is not safe, this temporary exemption from the requirement of a tolerance may be revoked at 

any time. 

[71 FR 13273, Mar. 15, 2006] 

§ 174.457 Bacillus thuringiensis 

Cry34Ab1 and Cry35Ab1 proteins 

and the genetic material necessary 

for their production in corn; exemption from the requirement of a tolerance. 

Bacillus thuringiensis Cry34Ab1 and 

Cry35Ab1 proteins and the genetic material necessary for their production in 

corn are exempted from the requirement of a tolerance when used as 

plant-incorporated protectants in the 

food and feed commodities of corn; 

corn, field; corn, sweet; and corn, pop. 

[70 FR 55260, Sept. 21, 2005] 

§ 174.475 Nucleic acids that are part of 

a plant-incorporated protectant; exemption from the requirement of a 

tolerance. 

Residues of nucleic acids that are 

part of a plant-incorporated protectant 

are exempt from the requirement of a 

tolerance. 

[66 FR 37830, July 19, 2001] 

§ 174.479 Pesticidal substance from 

sexually compatible plant; exemption from the requirement of a tolerance. 

Residues of a pesticidal substance 

that is part of a plant-incorporated 

protectant from a sexually compatible 

plant are exempt from the requirement 

of a tolerance if all the following conditions are met: 

(a) The genetic material that encodes 

for the pesticidal substance or leads to 

the production of the pesticidal substance is from a plant that is sexually 

compatible with the recipient food 

plant. 

(b) The genetic material has never 

been derived from a source that is not 

sexually compatible with the recipient 

food plant. 

(c) The residues of the pesticidal substance are not present in food from the 

plant at levels that are injurious or 

deleterious to human health. 

[66 FR 37854, July 19, 2001] 

Subpart X—List of Approved Inert 

Ingredients 

§ 174.480 Scope and purpose. 

This subpart lists the inert ingredients that have been exempted from 

FIFRA and FFDCA section 408 requirements and may be used in a plant-incorporated protectant listed in subpart 

B of this part. 

§ 174.485 Inert ingredients from sexually compatible plant. 

An inert ingredient, and residues of 

the inert ingredient, are exempt if all 

of the following conditions are met: 

(a) The genetic material that encodes 

the inert ingredient or leads to the production of the inert ingredient is derived from a plant sexually compatible 

with the recipient food plant. 

(b) The genetic material has never 

been derived from a source that is not 

sexually compatible with the recipient 

food plant. 

(c) The residues of the inert ingredient are not present in food from the 

plant at levels that are injurious or 

deleterious to human health. 

Subparts Y–Z [Reserved] 

PART 176—TIME-LIMITED TOLERANCES FOR EMERGENCY EXEMPTIONS 

Sec. 

176.1 Scope and applicability. 

176.3 Definitions. 

176.5 Establishment of a time-limited tolerance or exemption. 

176.7 Information needed to establish a tolerance. 

176.9 Publication of a tolerance. 

176.11 Duration of a tolerance. 

176.13 Modification of a time-limited tolerance. 

176.15 Effect of a tolerance. 

AUTHORITY: 21 U.S.C. 346a and 371. 


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