63956 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issue(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

A record has been established for this

rulemaking under docket number [PP

5F4584/R2190] (including comments

and data submitted electronically as

described below). A public version of

this record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

inspection from 8 a.m. to 4:30 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, Crystal Mall #2,

1921 Jefferson Davis Highway,

Arlington, VA.

Electronic comments can be sent

directly to EPA at:

opp-Docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer all comments received

electronically into printed, paper form

as they are received and will place the

paper copies in the official rulemaking

record which will also include all

comments submitted directly in writing.

The official rulemaking record is the

paper record maintained at the address

in ‘‘ADDRESSES’’ at the beginning of

this document.

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: November 28, 1995.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR part 180 is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.472, paragraph (e) is

amended by redesignating the existing

text as paragraph (e)(1), by revising the

table therein, and by adding paragraph

(e)(2) to read as follows:

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

N-2-imidazolidinimine; tolerances for

residues.

* * * * *

(e) * * *

Commodity Parts per

million

Expiration

date

Barley, forage ... 1.5 Nov. 28,

1998

Barley, grain ..... 0.05 Do.

Commodity Parts per

million

Expiration

date

Barley, straw ..... 0.2 Do.

Beets, sugar

(roots) ............ 0.05 August 24,

1998

Beets, sugar

(tops) ............. 0.1 Do.

Wheat, forage ... 7.0 Do.

Wheat, grain ..... 0.05 Do.

Wheat, straw ..... 0.3 Do.

(2) Residues in the commodities listed

in paragraph (e)(1) of this section not in

excess of the established tolerances

resulting from the uses described in this

paragraph (e) remaining after expiration

of the time-limited tolerances will not

be considered to be actionable if the

insecticide is applied during the term of

and in accordance with the provisions

of the above regulation in this paragraph

(e).

[FR Doc. 95–29987 Filed 12–12–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 1E3979/R2187; FRL–4985–8]

RIN 2070–AB78

Clopyralid; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes a

tolerance for residues of the herbicide

clopyralid in or on the raw agricultural

commodity asparagus. The regulation to

establish a maximum permissible level

for residues of the herbicide was

requested in a petition submitted by the

Interregional Research Project No. 4 (IR4) pursuant to the Federal Food, Drug

and Cosmetic Act (FFDCA).

EFFECTIVE DATE: This regulation

becomes effective December 13, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 1E3979/

R2187], may be submitted to: Hearing

Clerk (1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk should be

identified by the document control

number and submitted to: Public
Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations 63957

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 copy of objections and

hearing requests to: Rm. 1132, CM #2,

1921 Jefferson Davis Hwy., Arlington,

VA 22202.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect in 5.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket number [PP 1E3979/R2187].

No Confidential Business Information

(CBI) should be submitted through email. Electronic copies of objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

below in this document.

FOR FURTHER INFORMATION CONTACT: By

mail: Hoyt L. Jamerson, Registration

Support Branch, Registration Division

(7505W), Environmental Protection

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

DC 20460. Office location and telephone

number: 6th Floor, 2800 Crystal Drive,

North Tower, Arlington, VA 22202,

(703)-308-8783; e-mail:

jamerson.hoyt@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of September 29, 1995

(60 FR 50512), EPA issued a proposed

rule that gave notice that the

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

Station, P.O. Box 231, Rutgers

University, New Brunswick, NJ 08903,

had submitted a pesticide petition (PP

1E3979) to EPA on behalf of the IR-4

Agricultural Experiment Stations of

Arkansas, California, Maryland,

Michigan, Minnesota, and Washington.

The petition requests that the

Administrator, pursuant to section

408(e) of the FFDCA, 21 U.S.C. 346a(e),

amend 40 CFR 180.431 by establishing

a tolerance for residues of the herbicide

clopyralid (3,6-dichloro-2-

pyridinecarboxylic acid) in or on the

raw agricultural commodity asparagus

at 1.0 part per million (ppm).

There were no comments or requests

for referral to an advisory committee

received in response to the proposed

rule.

The data submitted with the proposal

and other relevant material have been

evaluated and discussed in the

proposed rule. Based on the data and

information considered, the Agency

concludes that the tolerance will protect

the public health. Therefore, the

tolerance is established as set forth

below.

Any person adversely affected by this

regulation may, within 30 days after

publication of this document in the

Federal Register, file written objections

and/or request a hearing with the

Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issue(s) on

which a hearing is requested, the

requestor’s contentions on such issues,

and a summary of any evidence relied

upon by the objector (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issue(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

A record has been established for this

rulemaking under docket number [PP

1E3979/R2187] (including any

objections and hearing requests

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8 a.m. to

4:30 p.m., Monday through Friday,

excluding legal holidays. The public

record is located in Room 1132 of the

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Written objections and hearing

requests, identified by the document

control number [PP 1E3979/R2187],

may be submitted to the Hearing Clerk

(1900), Environmental Protection

Agency, Rm. 3708, 401 M St., SW.,

Washington, DC 20460.

A copy of electronic objections and

hearing requests filed with the Hearing

Clerk can be sent directly to EPA at:

opp-Docket@epamail.epa.gov

A copy of electronic objections and

hearing requests filed with the Hearing

Clerk must be submitted as an ASCII file

avoiding the use of special characters

and any form of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any objections and hearing

requests received electronically into

printed, paper form as they are received

and will place the paper copies in the

official rulemaking record which will

also include all objections and hearing

requests submitted directly in writing.

The official rulemaking record is the

paper record maintained at the address

in ‘‘ADDRESSES’’ at the beginning of

this document.

Under Executive Order 12866 (58 FR

51735, Oct. 4, 1993), the Agency must

determine whether the regulatory action

is ‘‘significant’’ and therefore subject to

review by the Office of Management and

Budget (OMB) and the requirements of

the Executive Order. Under section 3(f),

the order defines a ‘‘significant

regulatory action’’ as an action that is

likely to result in 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

referred to 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 the

rights and obligations of recipients

thereof; 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 the 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
63958 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations

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: November 21, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR part 180 is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. Section 180.431 is amended in

paragraph (a) in the table therein by

adding and alphabetically inserting an

entry for the commodity asparagus, to

read as follows:

§ 180.431 Clopyralid; tolerances for

residues.

* * * * *

(a) * * *

Commodity Parts per

million

Asparagus ................................. 1.0

* * * * *

* * * * *

[FR Doc. 95–30113 Filed 12–12–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 2F4063/R2183; FRL–4984–7]

RIN 2070–AB78

Metalaxyl; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes

tolerances for combined residues of the

fungicide metalaxyl [N-(2,6-

dimethylphenyl)-N-(methoxyacetyl)

alanine methyl ester] and its metabolites

containing the 2,6-dimethylaniline

moiety and N-(2-hydroxymethyl-6-

methylphenyl)-N-(methoxyacetyl)-

alanine methyl ester, each expressed as

metalaxyl equivalents, in or on grass

forage at 10.0 parts per million (ppm)

and grass hay at 25.0 ppm. Ciba-Geigy

Corp. submitted a petition pursuant to

the Federal Food, Drug and Cosmetic

Act (FFDCA) for the regulation to

establish a maximum permissible level

for residues of the fungicide.

EFFECTIVE DATE: The effective date of

this regulation is October 26, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 2F4063/

R2183], may be submitted to: Hearing

Clerk (1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections shall be

labeled Tolerance Petition Fees and

forwarded to EPA Headquarters

Accounting Operations Branch, OPP

(Tolerance Fees), P. O. Box 360277M,

Pittsburgh, PA 15251. A copy of any

objections and hearing requests filed

with the Hearing Clerk should be

identified by the document control

number and submitted 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 copy of objections and

hearing requests to Rm. 1132, CM #2,

1921 Jefferson Davis Hwy., Arlington,

VA 22202.

A copy of any objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect in 5.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the document number [PP 2F4063/

R2183]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries. Additional

information on electronic submissions

can be found below in this document.

FOR FURTHER INFORMATION CONTACT: By

mail: Connie B. Welch, Product

Manager (PM) 21, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location and telephone number:

Rm. 227, CM #2, 1921 Jefferson Davis

Highway, Arlington, VA 22202, (703)

305-6226; e-mail:

welch.connie@.epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a notice of filing, published in

the Federal Register of June 15, 1995

(60 FR 31465), which announced that

Ciba-Geigy Corp., P.O. Box 18300,

Greensboro, NC 27419, had submitted a

pesticide petition, PP 2F4063, to EPA

requesting that the Administrator,

pursuant to section 408(d) of the

FFDCA, 21 U.S.C. 346a(d), establish

tolerances for combined residues of the

fungicide metalaxyl [N-(2,6-

dimethylphenyl)-N-(methoxyacetyl)

alanine methyl ester] and its metabolites

containing the 2,6-dimethylaniline

moiety and N-(2-hydroxymethyl-6-

methylphenyl)-N-(methoxyacetyl)-

alanine methyl ester, each expressed as

metalaxyl equivalents, in or on grass

forage at 10.0 parts per million (ppm)

and grass hay at 25.0 ppm.

There were no comments received in

response to the notice of filing. The

scientific data submitted in the petition

and other relevant material have been

evaluated. The toxicological data

considered in support of the tolerance

include:

1. A 3-month dietary study in rats

with a no-observed-effect level (NOEL)

at 17.5 milligrams per kilogram (mg/kg)

body weight (bwt)/day (250 parts per

million (ppm)).

2. A developmental toxicity study in

rats with a NOEL of 50 mg/kg bwt for

developmental toxicity and maternal

toxicity.

3. A developmental toxicity study in

rabbits with a NOEL of 300 mg/kg bwt

highest dose tested (HDT). Metalaxyl

did not cause developmental toxicity,

even in the presence of maternal

toxicity.

4. Metalaxyl was negative in bacterial

and mammalian gene mutation. The

fungicide also did not increase the

frequency of reverse mutations in yeast.

Metalaxyl was negative in an in vivo

cytogenetics assay (hamsters) and a

dominant-lethal assay (mice).

Metalaxyl did not increase

unscheduled DNA synthesis in rat

primary hepatocytes or in human

fibroblasts. These results suggest that

metalaxyl is not genotoxic.

5. A three-generation rat reproduction

study with a NOEL of 63 mg/kg bwt/day

(1,250 ppm).

6. A 6-month dog feeding study with

a NOEL of 6.3 mg/kg bwt/day (250

ppm). Effects found at 25 mg/kg were

increased serum alkaline phosphatase

activity and increased liver weight and

liver-to-brain weight ratios without

histological changes.