402 

§ 173.8 40 CFR Ch. I (7–1–13 Edition) 

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. 

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 

174.500 Scope and purpose. 

174.501 Bacillus thuringiensis Vip3Aa protein 

in corn and cotton; exemption from the 

requirement of a tolerance. 

174.502 Bacillus thuringiensis Cry1A.105 protein; exemption from the requirement of 

a tolerance. 

174.504 Bacillus thuringiensis Cry1F protein 

in cotton; exemption from the requirement of a tolerance. 

174.505 Bacillus thuringiensis modified Cry3A 

protein (mCry3A) in corn; exemption 

from the requirement of a tolerance. 


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Environmental Protection Agency § 174.1 

174.506 Bacillus thuringiensis Cry34Ab1 and 

Cry35Ab1 proteins in corn; exemption 

from the requirement of a tolerance. 

174.507 Nucleic acids that are part of a 

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

174.508 Pesticidal substance from sexually 

compatible plant; exemption from the requirement of a tolerance. 

174.509 Bacillus thuringiensis Cry3A protein; 

exemption from the requirement of a tolerance. 

174.510 Bacillus thuringiensis Cry1Ac protein 

in all plants; exemption from the requirement of a tolerance. 

174.511 Bacillus thuringiensis Cry1Ab protein 

in all plants; exemption from the requirement of a tolerance. 

174.512 Coat Protein of Potato Virus Y; exemption from the requirement of a tolerance. 

174.513 Potato Leaf Roll Virus Resistance 

Gene (also known as orf1/orf2 gene); exemption from the requirement of a tolerance. 

174.514 Coat Protein of Watermelon Mosaic 

Virus-2 and Zucchini Yellow Mosaic 

Virus; exemption from the requirement 

for a tolerance. 

174.515 Coat Protein of Papaya Ringspot 

Virus; exemption from the requirement 

of a tolerance. 

174.516 Coat protein of cucumber mosaic 

virus; exemption from the requirement of 

a tolerance. 

174.517 Bacillus thuringiensis Cry9C protein 

in corn; exemption from the requirement 

of a tolerance. 

174.518 Bacillus thuringiensis Cry3Bb1 protein 

in corn; exemption from the requirement 

of a tolerance. 

174.519 Bacillus thuringiensis Cry2Ab2 protein 

in corn and cotton; exemption from the 

requirement of a tolerance. 

174.520 Bacillus thuringiensis Cry1F protein 

in corn; exemption from the requirement 

of a tolerance. 

174.521 Neomycin phosphotransferase II; exemption from the requirement of a tolerance. 

174.522 Phosphinothricin Acetyltransferase 

(PAT); exemption from the requirement 

of a tolerance. 

174.523 CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS) synthase in all 

plants; exemption from the requirement 

of a tolerance. 

174.524 Glyphosate Oxidoreductase GOX or 

GOXv247 in all plants; exemption from 

the requirement of a tolerance. 

174.525 E. coli B-D-glucuronidase enzyme as 

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

174.526 Hygromycin B phosphotransferase 

(APH4) marker protein in all plants; exemption from the requirement of a tolerance. 

174.527 Phosphomannose isomerase in all 

plants; exemption from the requirement 

of a tolerance. 

174.529 Bacillus thuringiensis modified 

Cry1Ab protein as identified under OECD 

Unique Identifier SYN–IR67B–1 in cotton; 

exemption from the requirement of a tolerance. 

174.530 Bacillus thuringiensis Cry2Ae protein in cotton; exemption from the requirement of a tolerance. 

174.531 Coat protein of plum pox virus; exemption from the requirement of a tolerance. 

174.532 Bacillus thuringiensis eCry3.1Ab 

protein in corn; exemption from the requirement of a tolerance. 

174.533 Glycine max Herbicide-Resistant 

Acetolactate Synthase (GM–HRA) inert 

ingredient; exemption from the requirement of a tolerance. 

Subpart X—List of Approved Inert 

Ingredients 

174.700 Scope and purpose. 

174.705 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 supersede the regulations found in parts 150 through 180 of 

this chapter to the extent that the regulations conflict. Unless otherwise superseded by this part, the regulations 


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§ 174.3 40 CFR Ch. I (7–1–13 Edition) 

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. 

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 


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Environmental Protection Agency § 174.9 

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). 

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 information submitted, and the 

information may be made available to 

the public, subject to section 10(g) of 


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§ 174.21 40 CFR Ch. I (7–1–13 Edition) 

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 

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 §§174.507 through 174.508, 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 §174.705. Plantincorporated protectants that are not 

exempt from the requirements of 

FIFRA under this subpart are subject 

to all the requirements of FIFRA. 

[66 FR 37814, July 19, 2001, as amended at 72 

FR 20434, Apr. 25, 2007] 

§ 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 subpart 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. 


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Environmental Protection Agency § 174.504 

(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 

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 

§ 174.500 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 food commodities. 

[72 FR 20434, Apr. 25, 2007] 

§ 174.501 Bacillus thuringiensis 

Vip3Aa protein in corn and cotton; 

exemption from the requirement of 

a tolerance. 

Residues of Bacillus thuringiensis 

Vip3Aa proteins in or on corn or cotton 

are exempt from the requirement of a 

tolerance when used as plant-incorporated protectants in or on the food 

and feed commodities of corn; corn, 

field; corn, sweet; corn, pop; and cotton; cotton, undelinted seed; cotton, 

refined oil; cotton, meal; cotton, hay; 

cotton, hulls; cotton, forage; and cotton, gin byproducts. 

[73 FR 45624, Aug. 6, 2008] 

§ 174.502 Bacillus thuringiensis 

Cry1A.105 protein; exemption from 

the requirement of a tolerance. 

(a) Residues of Bacillus thuringiensis 

Cry1A.105 protein in or on the food and 

feed commodities of corn; corn, field, 

flour; corn, field, forage; corn, field, 

grain; corn, field, grits; corn, field, 

meal; corn, field, refined oil; corn, 

field, stover; corn, sweet, forage; corn, 

sweet, kernel plus cob with husk removed; corn, sweet, stover; and corn, 

pop, grain and corn, pop, stover are exempt from the requirement of a tolerance when the Bacillus thuringiensis 

Cry1A.105 protein is used as a plant-incorporated protectant in these food and 

feed corn commodities. 

(b) A time-limited exemption from 

the requirement of a tolerance is established for residues of Bacillus 

thuringiensis Cry1A.105 protein in or on 

the food and feed commodities of cotton; cotton, forage; cotton, gin byproducts; cotton, hay; cotton, hulls; cotton, 

meal; cotton, refined oil; and cotton, 

undelinted seed when the Bacillus 

thuringiensis Cry1A.105 protein is used 

as a plant-incorporated protectant in 

these food and feed cotton commodities. The exemption from the requirement of a tolerance expires and is revoked on November 22, 2010. 

[74 FR 39543, Aug. 7, 2009] 

§ 174.504 Bacillus thuringiensis Cry1F 

protein in cotton; exemption from 

the requirement of a tolerance. 

Residues of Bacillus thuringiensis 

Cry1F protein in cotton are exempt 

from the requirement of a tolerance 


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§ 174.505 40 CFR Ch. I (7–1–13 Edition) 

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

of cotton. 

[72 FR 20434, Apr. 25, 2007] 

§ 174.505 Bacillus thuringiensis modified Cry3A protein (mCry3A) in 

corn; exemption from the requirement of a tolerance. 

Residues of Bacillus thuringiensis 

modified Cry3A protein (mCry3A) in 

corn are exempt from the requirement 

of a tolerance when used as plant-incorporated protectant in the food and 

feed commodities of corn; corn, field; 

corn, sweet; and corn, pop. 

[72 FR 20434, Apr. 25, 2007] 

§ 174.506 Bacillus thuringiensis 

Cry34Ab1 and Cry35Ab1 proteins in 

corn; exemption from the requirement of a tolerance. 

Residues of Bacillus thuringiensis 

Cry34Ab1 and Cry35Ab1 proteins 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. 

[72 FR 20434, Apr. 25, 2007] 

§ 174.507 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. Redesignated at 72 

FR 20434, April 25, 2007] 

§ 174.508 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. Redesignated at 72 

FR 20434, April 25, 2007] 

§ 174.509 Bacillus thuringiensis Cry3A 

protein; exemption from the requirement of a tolerance. 

Residues of Bacillus thuringiensis 

Cry3A protein are exempted from the 

requirement of a tolerance when used 

as a plant-incorporated protectant in 

potatoes. 

[72 FR 20435, Apr. 25, 2007] 

§ 174.510 Bacillus thuringiensis 

Cry1Ac protein in all plants; exemption from the requirement of a tolerance. 

Residues of Bacillus thuringiensis 

Cry1Ac protein in all plants are exempt 

from the requirement of a tolerance 

when used as plant-incorporated 

protectants in all food commodities. 

[72 FR 20435, Apr. 25, 2007] 

§ 174.511 Bacillus thuringiensis 

Cry1Ab protein in all plants; exemption from the requirement of a tolerance. 

Residues of Bacillus thuringiensis 

Cry1Ab protein in all plants are exempt 

from the requirement of a tolerance 

when used as plant-incorporated 

protectants in all food commodities. 

[72 FR 20435, Apr. 25, 2007] 

§ 174.512 Coat Protein of Potato Virus 

Y; exemption from the requirement 

of a tolerance. 

Residues of Coat Protein of Potato 

Virus Y are exempt from the requirement of a tolerance when used as a 

plant-incorporated protectant in or on 

all food commodities. 

[72 FR 20435, Apr. 25, 2007] 


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Environmental Protection Agency § 174.521 

§ 174.513 Potato Leaf Roll Virus Resistance Gene (also known as orf1/orf2 

gene); exemption from the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues of the plant-incorporated protectant Potato Leaf Roll Virus Resistance 

Gene (also known as orf1/orf2 gene) in 

or on all food commodities. 

[72 FR 20435, Apr. 25, 2007] 

§ 174.514 Coat Protein of Watermelon 

Mosaic Virus-2 and Zucchini Yellow 

Mosaic Virus; exemption from the 

requirement for a tolerance. 

Residues of Coat Protein of Watermelon Mosaic Virus-2 and Zucchini 

Yellow Mosaic Virus are exempt from 

the requirement of a tolerance when 

used as a plant-incorporated protectant 

in or on all food commodities. 

[72 FR 20435, Apr. 25, 2007] 

§ 174.515 Coat Protein of Papaya 

Ringspot Virus; exemption from the 

requirement of a tolerance. 

Residues of Coat Protein of Papaya 

Ringspot Virus are exempt from the requirement of a tolerance when used as 

a plant-incorporated protectant in or 

on all food commodities. 

[72 FR 20435, Apr. 25, 2007] 

§ 174.516 Coat protein of cucumber 

mosaic virus; exemption from the 

requirement of a tolerance. 

Residues of Coat Protein of Cucumber Mosaic Virus are exempt from the 

requirement of a tolerance when used 

as a plant-incorporated protectant in 

or on all food commodities. 

[72 FR 20435, Apr. 25, 2007] 

§ 174.517 Bacillus thuringiensis Cry9C 

protein in corn; exemption from the 

requirement of a tolerance. 

The plant-incorporated protectant 

Bacillus thuringiensis Cry9C protein in 

corn is exempted from the requirement 

of a tolerance for residues, only in corn 

used for feed; as well as in meat, poultry, milk, or eggs resulting from animals fed such feed. 

[72 FR 20435, Apr. 25, 2007] 

§ 174.518 Bacillus thuringiensis 

Cry3Bb1 protein in corn; exemption 

from the requirement of a tolerance. 

Residues of Bacillus thuringiensis 

Cry3Bb1 protein in corn are exempt 

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. 

[72 FR 20435, Apr. 25, 2007] 

§ 174.519 Bacillus thuringiensis 

Cry2Ab2 protein in corn and cotton; 

exemption from the requirement of 

a tolerance. 

Residues of Bacillus thuringiensis 

Cry2Ab2 protein in or on corn or cotton 

are exempt from the requirement of a 

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

commodities of corn; corn, field; corn, 

sweet; corn, pop; and cotton seed, cotton oil, cotton meal, cotton hay, cotton hulls, cotton forage, and cotton gin 

byproducts. 

[73 FR 37850, July 2, 2008] 

§ 174.520 Bacillus thuringiensis Cry1F 

protein in corn; exemption from the 

requirement of a tolerance. 

Residues of Bacillus thuringiensis 

Cry1F protein in corn are exempt 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. 

[72 FR 20435, Apr. 25, 2007] 

§ 174.521 Neomycin 

phosphotransferase II; exemption 

from the requirement of a tolerance. 

Residues of the neomycin 

phosphotransferase II (NPTII) enzyme 

are exempted from the requirement of 

a tolerance in all food commodities 

when used as a plant-incorporated protectant inert ingredient. 

[72 FR 20435, Apr. 25, 2007] 


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§ 174.522 40 CFR Ch. I (7–1–13 Edition) 

§ 174.522 Phosphinothricin 

Acetyltransferase (PAT); exemption 

from the requirement of a tolerance. 

Residues of the Phosphinothricin 

Acetyltransferase (PAT) enzyme are 

exempt from the requirement of a tolerance when used as plant-incorporated 

protectant inert ingredients in all food 

commodities. 

[72 FR 20435, Apr. 25, 2007] 

§ 174.523 CP4 Enolpyruvylshikimate-3- 

phosphate (CP4 EPSPS) synthase in 

all plants; exemption from the requirement of a tolerance. 

Residues of the CP4 

Enolpyruvylshikimate-3-phosphate 

(CP4 EPSPS) synthase enzyme in all 

plants are exempt from the requirement of a tolerance when used as 

plant-incorporated protectant inert ingredients in all food commodities. 

[72 FR 20435, Apr. 25, 2007] 

§ 174.524 Glyphosate Oxidoreductase 

GOX or GOXv247 in all plants; exemption from the requirement of a 

tolerance. 

Residues of the Glyphosate 

Oxidoreductase GOX or GOXv247 enzyme in all plants are exempt from the 

requirement of a tolerance when used 

as plant-incorporated protectant inert 

ingredients in all food commodities. 

[72 FR 20435, Apr. 25, 2007] 

§ 174.525 E. coli B-D-glucuronidase enzyme as a plant-incorporated protectant inert ingredient; exemption 

from the requirement of a tolerance. 

Residues of E. coli B-D-glucuronidase 

enzyme are exempt from the requirement of a tolerance when used as a 

plant-incorporated protectant inert ingredient in all food commodities. 

[72 FR 20435, Apr. 25, 2007] 

§ 174.526 Hygromycin B 

phosphotransferase (APH4) marker 

protein in all plants; exemption 

from the requirement of a tolerance. 

Residues of the Hygromycin B 

phosphotransferase (APH4) enzyme in 

all plants are exempt from the requirement of a tolerance when used as a 

plant-incorporated protectant inert ingredient in cotton. 

[72 FR 20435, Apr. 25, 2007] 

§ 174.527 Phosphomannose isomerase 

in all plants; exemption from the requirement of a tolerance. 

Residues of the phosphomannose 

isomerase (PMI) enzyme in plants are 

exempt from the requirement of a tolerance when used as plant-incorporated 

protectant inert ingredients in all food 

commodities. 

[72 FR 20435, Apr. 25, 2007] 

§ 174.529 Bacillus thuringiensis modified Cry1Ab protein as identified 

under OECD Unique Identifier 

SYN–IR67B–1 in cotton; exemption 

from the requirement of a tolerance. 

Residues of Bacillus thuringiensis 

modified Cry1Ab protein as identified 

under OECD Unique Identifier SYN– 

IR67B–1 are exempt from the requirement of a tolerance when used as a 

plant-incorporated protectant in cotton; cotton, undelinted seed; cotton, 

refined oil; cotton, meal; cotton, hay; 

cotton, hulls; cotton, forage; and cotton, gin byproducts. 

[73 FR 40764, July 16, 2008] 

§ 174.530 Bacillus thuringiensis 

Cry2Ae protein in cotton; exemption from the requirement of a tolerance. 

Residues of Bacillus thuringiensis 

Cry2Ae protein in or on the food and 

feed commodities of cotton; cotton, 

undelinted seed; cotton, gin byproducts; cotton, forage; cotton, hay; cotton, hulls; cotton, meal; and cotton, refined oil, are exempt from the requirement of a tolerance when Bacillus 

thuringiensis Cry2Ae protein is used as 

a plant-incorporated protectant in cotton. 

[77 FR 6475, Feb. 8, 2012] 


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Environmental Protection Agency § 176.1 

§ 174.531 Coat protein of plum pox 

virus; exemption from the requirement of a tolerance. 

Residues of the coat protein of plum 

pox virus in or on the food commodities of fruit, stone, Group 12; and almond, are exempt from the requirement of a tolerance in these food commodities when expressed by the plantincorporated protectant, coat protein 

gene of plum pox virus, and used in accordance with good agricultural practices. 

[75 FR 29435, May 26, 2010] 

§ 174.532 Bacillus thuringiensis 

eCry3.1Ab protein in corn; exemption from the requirement of a tolerance. 

Residues of Bacillus thuringiensis 

eCry3.1Ab protein in corn, in or on the 

food and feed commodities of corn; 

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

are exempt from the requirement of a 

tolerance when Bacillus thuringiensis 

eCry3.1Ab protein in corn is used as a 

plant-incorporated protectant. 

[77 FR 47291, Aug. 8, 2012] 

§ 174.533 Glycine max Herbicide-Resistant Acetolactate Synthase (GM– 

HRA) inert ingredient; exemption 

from the requirement of a tolerance. 

Residues of Glycine max herbicide-resistant acetolactate synthase (GM– 

HRA) enzyme in or on the food and feed 

commodities of soybean are exempt 

from the requirement of a tolerance 

when used as a plant-incorporated protectant inert ingredient. 

[78 FR 9321, Feb. 8, 2013] 

Subpart X—List of Approved Inert 

Ingredients 

§ 174.700 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. 

[66 FR 37814, July 19, 2001. Redesignated at 72 

FR 20434, Apr. 25, 2007] 

§ 174.705 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. 

[66 FR 37814, July 19, 2001. Redesignated at 72 

FR 20434, Apr. 25, 2007] 

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. 

SOURCE: 65 FR 64131, Oct. 25, 2000, unless 

otherwise noted. 

§ 176.1 Scope and applicability. 

This part describes the procedures 

and criteria under which EPA will establish time-limited tolerances and exemptions from the requirement of a 

tolerance for pesticide chemical residues associated with use of pesticides 

under emergency or crisis exemptions 

under FIFRA section 18. This part applies only to tolerances issued on the 

initiative of EPA as the result of the 

issuance of an emergency exemption or 

the declaration of a crisis exemption. 

This part does not cover time-limited 

tolerances in any other circumstances. 


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