Attachment D - 40 CFR 176

OMB Control Number 2070-0032; EPA ICR Number 0596.09
ICR ATTACHMENT D
40 CFR part 176

§ 174.480

40 CFR Ch. I (7–1–07 Edition)

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]
EFFECTIVE DATE NOTE: At 72 FR 20434, Apr.
25, 2007, § 174.479 was redesignated as § 174.508,
effective July 24, 2007

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.

Subpart X—List of Approved Inert
Ingredients
§ 174.480

PART 176—TIME-LIMITED TOLERANCES FOR EMERGENCY EXEMPTIONS

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.
EFFECTIVE DATE NOTE: At 72 FR 20434, Apr.
25, 2007, § 174.480 was redesignated as § 174.700
and remains in subpart X, effective July 24,
2007.

§ 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.
EFFECTIVE DATE NOTE: At 72 FR 20434, Apr.
25, 2007, § 174.485 was redesignated as § 174.705
and remains in subpart X, effective July 24,
2007.

Subparts Y–Z [Reserved]

§ 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.
§ 176.3 Definitions.
The terms have the same meaning as
in the Federal Insecticide, Fungicide,
and Rodenticide Act section 2, and in
the Federal Food, Drug, and Cosmetic
Act section 201 and § 166.3 of this chapter. In addition, the following terms
are defined for the purposes of this
part.
Agency means the U.S. Environmental Protection Agency.
Applicant means any entity authorized under section 18 of FIFRA to request an emergency exemption that requests such an exemption under § 166.20
of this chapter, or issues a crisis exemption under § 166.40 of this chapter.
Crisis exemption means an exemption
authorized under FIFRA section 18, in
accordance with § § 166.40 through 166.53
of this chapter.
Emergency exemption means a specific,
quarantine, or public health exemption

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Environmental Protection Agency

§ 176.13

authorized under FIFRA section 18 and
the regulations at § § 166.20 through
166.35 of this chapter.
EPA means the U.S. Environmental
Protection Agency.
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 (7
U.S.C 136 et seq.).
Tolerance
means
the
maximum
amount of a pesticide chemical residue
that may lawfully be present in or on a
raw agricultural commodity, or processed food, or animal feed, expressed as
parts per million by weight of the pesticide chemical residue in the food or
feed.
Tolerance exemption means a formal
determination by the Agency pursuant
to FFDCA section 408(c), 21 U.S.C
346a(c), that no tolerance is needed for
a given pesticide chemical residue in or
on a particular food commodity. For
purposes of this part, the term ‘‘tolerance’’ shall include an exemption from
the requirement of a tolerance.

account the limited duration and emergency nature of a section 18 application, and based on the available data
the Agency cannot conclude that there
is a reasonable certainty that no harm
will result from the use proposed by
the applicant or granted pursuant to a
crisis exemption, EPA will not establish a tolerance.
(b) Data and other relevant information to support the establishment of a
time-limited tolerance may be submitted by the applicant, or by any
other person, in support of the timelimited tolerance. The applicant may
also cite relevant data previously submitted to the Agency.
§ 176.9 Publication of a tolerance.
(a) If EPA issues an emergency exemption or crisis exemption under
FIFRA section 18, and EPA concludes
that the tolerance for residues resulting from use of the pesticide under the
exemption will be safe, then EPA will
establish the tolerance by publishing
an amendment to 40 CFR part 180 in
the FEDERAL REGISTER.
(b) A tolerance under this part may
be established without prior publication of a proposed tolerance or comment period.

§ 176.5 Establishment of a time-limited
tolerance or exemption.
EPA will establish a time-limited
tolerance for pesticide chemical residues in or on raw or processed food or
feed resulting from the use of a pesticide chemical, if EPA authorizes an
emergency exemption or a crisis exemption. EPA will consider establishing such a tolerance only if an applicant acting under authority of
FIFRA section 18 either has requested
an emergency exemption, has stated its
intention to issue a crisis exemption,
or has issued a crisis exemption for a
use that may result, directly or indirectly, in pesticide chemical residues
in food or feed.

§ 176.11 Duration of a tolerance.
(a) Tolerances issued under this part
will become effective upon publication
in the FEDERAL REGISTER, unless otherwise specified by the Administrator.
(b) Unless extended, tolerances will
automatically expire and be revoked,
without further action by EPA, at the
time set out in the final rule published
in FEDERAL REGISTER.
(c) The Administrator may revoke a
tolerance at any time if the Administrator determines that the tolerance is
no longer safe.

§ 176.7 Information needed to establish
a tolerance.
(a) EPA will establish a time-limited
tolerance only if EPA can determine
that the tolerance is safe, that is, there
is a reasonable certainty that no harm
will result from aggregate exposure to
the pesticide chemical residue. EPA
will base its determination upon data
submitted by the applicant and other
readily available data. If, taking into

§ 176.13 Modification of a time-limited
tolerance.
If additional emergency or crisis exemptions are authorized that would extend use beyond the date originally authorized, or if EPA determines that the
duration of a time-limited tolerance is
insufficient to allow treated commodities to clear the channels of trade,
EPA may modify the time-limited tolerance by publication of a final rule in

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§ 176.15

40 CFR Ch. I (7–1–07 Edition)

the FEDERAL REGISTER. EPA will use
the same criteria and procedures for
modification as for establishing tolerances under this part.
§ 176.15

Effect of a tolerance.

The establishment of a tolerance
under this part does not alter the requirement that any applicant comply
with procedures established in part 166
of this chapter for emergency exemptions of FIFRA.

[55 FR 50291, Dec. 5, 1990, as amended at 57
FR 28087, June 24, 1992]

PART 178—OBJECTIONS AND
REQUESTS FOR HEARINGS

Subpart B—Procedures for Filing
Objections and Requests for
Hearing

Subpart A—General Provisions
Sec.
178.3

Assistant Administrator means the
Agency’s Assistant Administrator for
Prevention, Pesticides and Toxic Substances, or any officer or employee of
the Agency’s Office of Prevention, Pesticides and Toxic Substances to whom
the Assistant Administrator delegates
the authority to perform functions
under this part.
FFDCA means the Federal Food,
Drug, and Cosmetic Act, as amended,
21 U.S.C. 301–392.

Definitions.

§ 178.20 Right to submit objections and
requests for a hearing.

Subpart B—Procedures for Filing
Objections and Requests for Hearing
178.20 Right to submit objections and requests for a hearing.
178.25 Form and manner of submission of
objections.
178.27 Form and manner of submission of request for evidentiary hearing.
178.30 Response by Administrator to objections and to requests for hearing.
178.32 Rulings on requests for hearing.
178.35 Modification or revocation of regulation or prior order.
178.37 Order responding to objections on
which a hearing was not requested or was
denied.

Subpart C [Reserved]
Subpart D—Judicial Review
178.65 Judicial review.
178.70 Administrative record.
AUTHORITY: 21 U.S.C. 346a, 371(a); Reorg.
Plan No. 3 of 1970.
SOURCE: 55 FR 50291, Dec. 5, 1990, unless
otherwise noted.

Subpart A—General Provisions
§ 178.3

Definitions.

For the purposes of this part:
Administrator means the Administrator of the Agency, or any officer or
employee of the Agency to whom the
Administrator delegates the authority
to perform functions under this part.
Agency means the United States Environmental Protection Agency.

(a) On or before the 60th day after the
date of publication in the FEDERAL
REGISTER of an order under part 180 of
this chapter establishing, modifying, or
revoking a regulation, or denying all or
any portion of a petition, a person adversely affected by such order or petition denial may submit, in accordance
with § 178.25, one or more written objections to the order (or to the action that
is the subject of the order).
(b) A person may include with any
such objection a written request for an
evidentiary hearing on such objection
in accordance with § 178.27
(c) A person who submits objections
need not request a hearing. For instance, if the person’s objections are of
a purely legal or policy nature, a hearing request would be inappropriate; the
purpose of an evidentiary hearing is to
resolve factual disputes. The Administrator will rule on the objections,
whether or not a hearing is requested.
(d) As a matter of discretion, the Administrator may order a hearing on an
objection even though no person has
requested a hearing.
[55 FR 50291, Dec. 5, 1990, as amended at 70
FR 33359, June 8, 2005]

§ 178.25 Form and manner of submission of objections.
(a) To be considered by the Administrator, an objection must:
(1) Be in writing.

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