9816 Federal Register / Vol. 60, No. 35 / Wednesday, February 22, 1995 / Proposed Rules

that this rulemaking proposal be

referred to an Advisory Committee in

accordance with FFDCA section 408(e).

Interested person are invited to

submit written comments on the

proposed regulation. Comments must

bear notation indicating the document

control number, [OPP-300379]. All

written comments filed in response to

this document will be be available in

the Public Docket and Freedom of

Information Section, at the addressed

given above from 8 a.m. to 4 p.m,

Monday through Friday, except legal

holidays.

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96-

354, 94 Stat. 1164, 5 U.S.C. 601-612),

the Administrator has determined that

regulations establishing exemption from

tolerance requirements do not have a

significant economic impact on a

substantial number of small entities. A

certification statement to this effect was

published in the Federal Register of

May 4, 1981 (46 FR 24950).

List of Subjects in 40 CFR Part 180

Administrative practice and

procedure, Agricultural commodities,

Pesticides and pests, Reporting and

recordkeeping requirements.

Dated: February 10, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, it is proposed that chapter

I of title 40 of the Code of Federal

Regulations be amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to as follows:

Authority: 21 U.S.C. 346a and 371.

2. In 180.472, by revising paragraph

(d), to read as follows:

§ 180.472 1-[(6-Chloro-3-pyridinyl) methyl]-

N-nitro-2-imidazolidinimine; tolerances for

residues.

* * * * *

(d) A time-limited tolerance, to expire

June 28, 1996, is established permitting

the combined residues of the insecticide

1-[(6-chloro-3-pyridinyl)methyl]-Nnitro-2-imidazolidinimine and its

metabolites containing the

chloropyridinyl moiety, all expressed as

1-[(6-chloro-3-pyridinyl)methyl]-Nnitro-2-imidazolidinimine, in or on the

following raw agricultural commodity:

Commodity Parts per

million

Hops, dried ............................... 3.0

[FR Doc. 95–4185 Filed 2–21–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 2E4071/P603; FRL 4936–2]

RIN 2070–AC18

Methyl Anthranilate; Exemptions from

the Requirement of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish

exemptions from the requirement of a

tolerance for residues of the biochemical

methyl anthranilate in or on the raw

agricultural commodities blueberry,

cherry, and grape when the pesticide is

used in accordance with good

agricultural practices. The Interregional

Research Project No. 4 (IR-4) requested

these exemptions in a petition

submitted to EPA.

DATES: Comments, identified by the

document control number, [PP 2E4071/

P603], must be received on or before

March 24, 1995.

ADDRESSES: By mail, submit written

comments to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW,

Washington, DC 20460. In person, bring

comments to: Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA

22202. Information submitted as a

comment concerning this notice may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI).

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the comment that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Hoyt Jamerson, Registration

Division (7505W), Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location

and telephone number: Sixth Floor,

Crystal Station #1, 2800 Jefferson Davis

Hwy., Arlington, VA 22202, (703)-308-

8783.

SUPPLEMENTARY INFORMATION: The

Interregional Research Project No. 4 (IR4), New Jersey Agricultural Experiment

Station, P.O. Box 231, Rutgers

University, New Brunswick, NJ 08903,

has submitted pesticide petition (PP)

2E4071 to EPA on behalf of the

Agricultural Experiment Station of

Washington. Pesticide petition 2E4071

requests that the Administrator,

pursuant to section 408(e) of the Federal

Food, Drug and Cosmetic Act (FFDCA),

21 U.S.C. 346a(e), establish exemptions

from the requirement of a tolerance for

residues of the biochemical methyl

anthranilate in or on the raw

agricultural commodities blueberry,

cherry, and grape. Methyl anthranilate

will be applied as a dilute foliar spray

to these crops to repel birds and reduce

bird depredation. Methyl anthranilate is

a natural constituent of food that can be

found in grape and citrus. Methyl

anthranilate is also synthetically

produced and used in the purified form

(not less than 99 percent pure) as a

flavoring agent in beverages, ice cream,

candy, baked goods, gelatins, puddings,

and chewing gum. The synthetic

product mimics the chemical structure

and function of the natural plant

constituent. Methyl anthranilate is

listed by the Food and Drug

Administration (FDA) as a flavoring

compound under 21 CFR 182.60, and is

classified generally recognized as safe

(GRAS) by the Expert Panel of the

Flavor and Extract Manufacturer’s

Association (FEMA). Registrants who

produce end-use products for this active

ingredient that are intended for use on

blueberry, cherry, or grape will be

required to use methyl anthranilate

produced to meet or exceed U.S. Food

Chemical Codex and U.S.

Pharmacopoeia specifications.

Residue data submitted with the

petition indicate that residues of methyl

anthranilate would not exceed 35 parts

per million (ppm) on blueberry, cherry,

and grape from the proposed use. The

incremental dietary exposure to methyl

anthranilate is not significant compared

to naturally occurring levels, or levels

resulting from use of the chemical as a

flavoring agent. For example, naturally

occurring levels of methyl anthranilate

are reported at 33 ppm in concord

grapes, and the use of methyl

anthranilate as a flavoring agent results

in residues of approximately 30 ppm in
Federal Register / Vol. 60, No. 35 / Wednesday, February 22, 1995 / Proposed Rules 9817

baked goods and hard candies and

almost 400 ppm in chewing gum.

Methyl anthranilate is hydrolyzed in

the small intestine to form an alcohol

and either anthranilic acid or an N-alkyl

anthranilic acid. Anthranilic acid is a

common human metabolite that is

excreted in the urine or converted to

anthranilic acid glucuronide prior to

excretion.

The available information is sufficient

to demonstrate that there are no

foreseeable human health hazards likely

to arise from dietary exposure resulting

from the proposed use of methyl

anthranilate on blueberry, cherry, and

grape.

There is also no reasonable

expectation of secondary residues in

meat, milk, poultry, or eggs from the

proposed use.

No enforcement actions based on the

level of residues in food are expected.

Therefore, the requirement for an

analytical method for enforcement

purposes is not applicable to the

exemption from the requirement of a

tolerance.

Based on the information and data

considered, the Agency concludes that

tolerances are not needed to protect the

public health. Therefore, it is proposed

that the exemptions from the

requirement of a tolerance be

established as set forth below.

Any person who has registered or

submitted an application for registration

of a pesticide, under the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA) as amended, which

contains any of the ingredients listed

herein, may request within 30 days after

publication of this notice in the Federal

Register that this rulemaking proposal

be referred to an Advisory Committee in

accordance with section 408(e) of the

FFDCA.

Interested persons are invited to

submit written comments on the

proposed regulation. Comments must

bear a notation indicating the document

control number, [PP 2E4071/P603]. All

written comments filed in response to

this petition will be available in the

Public Response and Program Resources

Branch, at the address given above from

8 a.m. to 4 p.m., Monday through

Friday, except legal holidays.

Under Executive Order 12866 (58 FR

51735, October 4, 1993), the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to all the requirements of the

Executive Order (i.e., Regulatory Impact

Analysis, review by the Office of

Management and Budget (OMB)). Under

section 3(f), the order defines

‘‘significant’’ as those actions likely to

lead to a rule (1) having an annual effect

on the economy of $100 million or

more, or adversely and materially

affecting a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local or tribal governments or

communities (also known as

‘‘economically significant’’); (2) creating

serious inconsistency or otherwise

interfering with an action taken or

planned by another agency; (3)

materially altering the budgetary

impacts of entitlement, grants, user fees,

or loan programs; or (4) raising novel

legal or policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in this Executive

Order.

Pursuant to the terms of this

Executive Order, EPA has determined

that this rule is not ‘‘significant’’ and is

therefore not subject to OMB review.

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96-

354, 94 Stat. 1164, 5 U.S.C. 601-612),

the Administrator has determined that

regulations establishing new tolerances

or raising tolerance levels or

establishing exemptions from tolerance

requirements do not have a significant

economic impact on a substantial

number of small entities. A certification

statement to this effect was published in

the Federal Register of May 4, 1981 (46

FR 24950).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: February 9, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

PART 180—[AMENDED]

Therefore, it is proposed that 40 CFR

part 180 be amended as follows:

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346A and 371.

2. In Subpart D, by adding new

§ 180.1143, to read as follows:

§ 180.1143 Methyl anthranilate; exemption

from the requirement of a tolerance.

Methyl anthranilate, a biochemical

pesticide, is exempt from the

requirement of a tolerance when used in

accordance with good agricultural

practices on the following raw

agricultural commodities: Blueberry,

cherry, and grape.

[FR Doc. 95–4306 Filed 2–16–95; 2:39 pm]

BILLING CODE 6560–50–F