312 

§ 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 

Subpart X—List of Approved Inert 

Ingredients 

§ 174.480 Scope and purpose. 

This subpart lists the inert ingredients that have been exempted from 

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

B of this part. 

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] 

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. 

§ 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 


ICR ATTACHMENT C

40 CFR part 176
313 

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. 

§ 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. 

§ 176.7 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 

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. 

§ 176.11 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. 

§ 176.13 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 

314 

§ 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. 

PART 178—OBJECTIONS AND 

REQUESTS FOR HEARINGS 

Subpart A—General Provisions 

Sec. 

178.3 Definitions. 

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. 

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. 

[55 FR 50291, Dec. 5, 1990, as amended at 57 

FR 28087, June 24, 1992] 

Subpart B—Procedures for Filing 

Objections and Requests for 

Hearing 

§ 178.20 Right to submit objections and 

requests for a hearing. 

(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.