Attachment A - 40 CFR part 174 - Procedures and Requirements for Plant-Incorporated Protectants

ICR ATTACHMENT A
40 CFR 174
Page 1 of 7

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.

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§ 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rescind be withdrawn and that the rescission proceeding be terminated.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use violations be rescinded in whole or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
174.3

Scope and purpose.
Definitions.

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ICR ATTACHMENT A
40 CFR 174
Page 2 of 7

§ 174.1

40 CFR Ch. I (7–1–06 Edition)

174.9 Confidential
business
information
claims for plant-incorporated protectant
submissions.

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

Subpart B—Exemptions

Subparts X—List of Approved Inert
Ingredients

174.21 General qualifications for exemptions.
174.25 Plant-incorporated protectant from
sexually compatible plant.

174.480 Scope and purpose.
174.485 Inert ingredients from sexually compatible plant.

Subpart C—Registration Procedures and
Requirements [Reserved]

Subparts Y–Z [Reserved]

Subpart D—Monitoring and Recordkeeping

AUTHORITY: 7 U.S.C. 136–136y; 21 U.S.C. 346a
and 371.

174.71 Submission of information regarding
adverse effects.

SOURCE: 66 FR 37814, July 19, 2001, unless
otherwise noted.

Subparts E–F [Reserved]

Subpart A—General Provisions

Subpart G—Labeling Requirements
[Reserved]

§ 174.1

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]

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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.

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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ICR ATTACHMENT A
40 CFR 174
Page 3 of 7

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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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ICR ATTACHMENT A
40 CFR 174
Page 4 of 7

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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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ICR ATTACHMENT A
40 CFR 174
Page 5 of 7

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.

hmoore on PROD1PC68 with HMCFR

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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OMB Control Number 2070-0142; EPA ICR Number 1693.05
ICR ATTACHMENT A
40 CFR 174
Page 6 of 7

§ 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]

[71 FR 24586, Apr. 26, 2006]

Subpart G—Labeling [Reserved]

§ 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.

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]

[69 FR 58284, Sept. 30, 2004]

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.

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gions. 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.

§ 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 re-

§ 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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ICR ATTACHMENT A
40 CFR 174
Page 7 of 7

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.

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.

[71 FR 13273, Mar. 15, 2006]

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.

§ 174.457 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 37854, July 19, 2001]

Subpart X—List of Approved Inert
Ingredients
§ 174.480

§ 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.

[66 FR 37830, July 19, 2001]

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Scope and purpose.

Subparts Y–Z [Reserved]

§ 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

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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