Federal Register / Vol. 60, No. 35 / Wednesday, February 22, 1995 / Proposed Rules 9815

List of Subjects in 40 CFR Part 81

Environmental protection, Air

pollution control, National parks,

Wilderness areas.

Authority: 42 U.S.C. 7401–7671q.

Dated: January 25, 1995.

John P. DeVillars,

Regional Administrator, Region I.

[FR Doc. 95–4295 Filed 2–21–95; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 180

[OPP–300379; FRL–4934–8]

RIN 2070–AC18

Extended Tolerance on Dried Hops for

Imidacloprid

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to extend the

tolerance for residues of the insecticide

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

metabolites (common name

‘‘imidacloprid’’) in or on dried hops at

3.0 parts per million (ppm). On its own

inititative, EPA proposes to extend the

tolerance to allow time to review a

petition from the Interregional Research

Project No. 4 (IR-4).

DATES: Written comments, identified by

the document control number, [OPP300379], may be submitted on or before

March 24, 1995.

ADDRESSES: Comments may be

submitted to: Public Docket and

Freedom of Information Section, Field

Operations Division (7506C), Office of

Pesticide Programs, 401 M St., SW.,

Washington, DC 20604. In person, bring

comments to: Rm. 1132, CM #2,

Arlington, VA 22202.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information

‘‘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 below, from 8 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Dennis H. Edwards, Jr., Product

Manager (PM) 19, Registration Division

(7505C), Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location and telephone

number: Rm. 207, CM #2, 1921 Jefferson

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

305-6386.

SUPPLEMENTARY INFORMATION: On its

own initiative and pursuant to section

408(e) of the Federal Food, Drug, and

Cosmetic Act (FFDCA), 21 U.S.C.

346a(e), the Agency established in 40

CFR 180.472 a time-limited tolerance for

the residues of imidacloprid on dried

hops at 3.0 parts per million (ppm) (see

the Federal Register of June 28, 1994

(59 FR 33204)). EPA established this

tolerance because EPA had granted a

petition for an emergency exemption

under section 18 of the Federal

Insecticide, Fungicide and Rodenticide

Act, 7 U.S.C. 136p, for the use of

imidacloprid on hops in the States of

Washington, Oregon, and Idaho;

imidacloprid is used in other countries

which export hops to the United States;

and the database for imidacloprid is

relatively complete. At that time, a third

field residue trial was outstanding.

Since then, the Interregional Research

Project No. 4 (IR-4) has submitted a

pesticide petition to the Agency

requesting that a tolerance be

established in or on dried hops. This

petition is currently in review. The

Agency may not complete its review of

the IR-4 petition before the time-limited

tolerance would expire. EPA does not

believe that its risk assessment will

significantly change as a result of the IR4 petition. Therefore, the Agency is

proposing to extend this tolerance for an

additional 1-year period, i.e., to June 28,

1996.

In the Federal Register of November

30, 1994 (59 FR 61278), EPA revised 40

CFR 180.472 and removed the timelimited designation for commodities

listed in paragraph (a). The listing for

‘‘Hops, dried’’ at 3.0 ppm inadvertently

was left in paragraph (a) in the new list

of commodities without a time-limited

designation. Hops should have retained

the time-limited designation, June 28,

1995, and been moved to a new

paragraph. This change was made by a

technical amendment published in the

Federal Register of February 22, 1995.

All relevant materials have been

evaluated. The toxicology data

considered in support of the tolerance

include:

1. A three generation rat reproduction

study that showed a NOEL of 100 ppm

(8 mg/kg/bwt); rat and rabbit teratology

studies were negative at doses up to 30

mg/kg/bwt and 24 mg/kg/bwt,

respectively.

2. A 2-year rat feeding/carcinogenicity

study that was negative for carcinogenic

effects under the conditions of the study

and had a NOEL of 100 ppm (5.7 mg/

kg/bwt in males and 7.6 mg/kg/bwt in

females) for noncarcinogenic effects,

which included decreased body weight

gain in females at 300 ppm and

increased thyroid lesions in males at

300 ppm and females at 900 ppm.

3. A 1-year dog feeding study that

showed a NOEL of 1,250 ppm (41/mg/

kg/bwt).

4. A 2-year mouse carcinogenicity

study that was negative for carcinogenic

effects under the conditions of the study

and had a NOEL of 1,000 ppm (208 mg/

kg/day).

There is no cancer risk associated

with exposure to this chemical.

Imidacloprid has been classified as a

‘‘Group E’’ (no evidence of

carcinogenicity for humans) carcinogen

by the OPP Reference Dose (RfD)

Committee.

The reference dose (RfD), based on the

2-year rat feeding/carcinogenic study

with a NOEL of 5.7 mg/kg/bwt and 100-

fold uncertainty factor, is calculated to

be 0.057 mg/kg/bwt. The theoretical

maximum residue contribution (TMRC)

from the proposed tolerances is

0.000984 mg/kg/bwt/day and utilizes

2% percent of the ADI.

The nature of the residue in plants

and livestock is adequately understood.

Spent hops are not considered a poultry

feed item; therefore, secondary

imidacloprid tolerances for poultry and

eggs are not required. The analytical

method is a common moiety method for

imidacloprid and its metabolites

containing the 6-chloropyridinyl moiety

in plants using a permanganate

oxidation, silyl derivatization, and

capillary GC-MS-selective ion

monitoring. The magnitude of the

residue crop field trial data for

imidacloprid on hops indicates that

residues of total imidacloprid will not

exceed the proposed tolerance when the

formulations are used as directed. The

extension for this use will expire on

June 28, 1996.

This pesticide is considered useful for

the purposes for which the tolerances

are sought. Based on the above

information considered by the Agency,

the tolerance established by amending

40 CFR part 180 would protect the

public health. Therefore, it is proposed

that the tolerance be established as set

forth below. Any person who has

registered or submitted an application

for registration of a pesticide, under

FIFRA, as amended, which contains any

of the ingredients listed herein, may

request within 30 days after publication

of this document in the Federal Register
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