Attachment A- 40 CFR 174

§ 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.

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§ 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; ex-

emption 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.

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§ 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.

wreier-aviles on DSK5TPTVN1PROD with CFR

[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

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§ 174.500

Scope and purpose.

§ 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]

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]

§ 174.504 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
fied
corn;
ment

Bacillus thuringiensis modiCry3A protein (mCry3A) in
exemption from the requireof 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]

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§ 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.

§ 174.518 Bacillus
thuringiensis
Cry3Bb1 protein in corn; 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.

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]

§ 174.514 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.

§ 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.

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.

[73 FR 37850, July 2, 2008]

[72 FR 20435, Apr. 25, 2007]

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.

§ 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.

wreier-aviles on DSK5TPTVN1PROD with CFR

[72 FR 20435, Apr. 25, 2007]

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.

§ 174.520 Bacillus thuringiensis Cry1F
protein in corn; exemption from the
requirement of a tolerance.

[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]

[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.

plant-incorporated protectant inert ingredient in cotton.

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.

§ 174.527 Phosphomannose isomerase
in all plants; exemption from the requirement of a tolerance.

[72 FR 20435, Apr. 25, 2007]

§ 174.523 CP4 Enolpyruvylshikimate-3phosphate (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]

wreier-aviles on DSK5TPTVN1PROD with CFR

§ 174.526 Hygromycin
B
phosphotransferase (APH4) marker
protein in all plants; exemption
from the requirement of a tolerance.

[72 FR 20435, Apr. 25, 2007]

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]

Residues of the Hygromycin B
phosphotransferase (APH4) enzyme in
all plants are exempt from the requirement of a tolerance when used as a

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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.

Subpart X—List of Approved Inert
Ingredients

wreier-aviles on DSK5TPTVN1PROD with CFR

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

[78 FR 9321, Feb. 8, 2013]

§ 174.700

§ 174.705 Inert ingredients from sexually compatible plant.

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]

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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