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.
Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations 63959

7. A 2-year rat chronic feeding/

carcinogenicity study with no

compound-related carcinogenic effects

under the conditions of the study at

dietary levels up to 1,250 ppm. The

NOEL is 13 mg/kg bwt/day (250 ppm).

The lowest-observed-effect level (LOEL)

is 63 mg/kg/day based upon slight

increases in liver weight to body weight

ratios and periacinar vacuolation of

hepatocytes.

8. A 2-year mouse oncogenic study

with no compound-related carcinogenic

effects under the conditions of the study

at dietary levels up to 190 mg/kg/day.

Because of concerns raised over some

equivocal increases in tumor incidences

in the male mouse liver and the male rat

adrenal medulla, and the female rat

thyroid, the two chronic feeding studies

were submitted to the Environmental

Pathology Laboratories (EPL) for an

independent reading of the microscopic

slides. The new pathological evaluation

by EPL and the original reports of the rat

and mouse oncogenicity studies were

then both submitted for review to EPA’s

Carcinogen Assessment Group (CAG). A

final review of the carcinogenicity

studies and related material was

performed by the Peer Review

Committee of the Toxicology Branch

(TB) of the Office of Pesticide Programs

(OPP).

The four major issues evaluated by

CAG and the peer review group

included: (1) Perifollicular cell

adenomas in the thyroid of female rats;

(2) adrenal medullary tumors

(pheochromocytomas) in male rats; (3)

liver tumors in male mice; and (4)

whether the HDT (1,250 ppm) in the rat

and mouse oncogenicity studies

represented a maximum-tolerated dose

(MTD).

Regarding the thyroid tumors in

female rats, the peer review group

concluded that the increased incidences

of thyroid tumors in females of treated

groups were not compound related. This

conclusion was based on the following:

(1) There was no progression of benign

tumors (adenomas) to malignancy

(carcinomas); (2) there was no increase

in hyperplastic changes; (3) there was

no dose-response relationship; and (4)

the two reevaluations of the microscopic

slides by the pathologists at EPL and TB

in OPP further did not confirm any

apparent effects observed in the original

report.

The issue of a possible treatmentrelated increase of adrenal medullary

gland tumors, namely,

pheochromocytomas, in the male rat

was also reassessed by both CAG and

the Peer Review Committee. Both

concluded that the data, especially in

view of the reevaluation of the

microscopic slides performed by EPL,

did not support a compound-related

increase of adrenal medullary tumors;

the incidence of pheochromocytomas

more accurately represented

spontaneous variations of a commonly

occurring tumor in the aged rat.

The analysis of the significance of the

equivocal increase in the incidence of

liver tumors in male mice was very

similar to that performed for the rat

thyroid and adrenal gland tumors. The

original pathological reading of the

tissue slides reported an elevated

increase of tumors in some treatment

groups; however, these increases were

not evident after a reevaluation of

themicroscopic slides was performed by

an independent pathologist at EPL and

by the reading of a CAG pathologist. The

Peer Review Committee concurred that

the reevaluation of the slides is reliable

and does not show any compoundrelated increase in the incidence ofliver

tumors in the mouse.

The Agency believes that the data

from the rat and mouse long-term

studies are sufficient to support the

conclusion that metalaxyl does not

show a carcinogenic potential in

laboratory animals. This conclusion is

supported by the following: (1) The

doses tested in both the rat and mouse

long-term studies approached an MTD

based upon compound-related changes

in liver weight and/or liver histology;

(2) extensive available mutagenic

evidence indicates no potential

genotoxic activity which correlates with

the negative carcinogenic potential

demonstrated in long-term testing; (3)

metalaxyl is not structurally related to

known carcinogens; and (4) under the

conditions of the rat and mouse tests, no

indication of compound-related

carcinogenic effects was noted at any of

the treatment doses, sexes, or species.

The reference dose (RfD), anticipated

residue contribution (ARC), and food

additive regulations are covered by

existing tolerances.

The nature of the residue is

adequately understood. The

enforcement methodology has been

submitted to the Food and Drug

Administration for publication in the

Pesticide Analytical Manual, Volume II

(PAM II). Because of the long lead time

for publication of the method in PAM II,

the analytical methodology is being

made available in the interim to anyone

interested in pesticide enforcement

when requested from: Calvin Furlow,

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 1132, CM #2, 1921 Jefferson Davis

Highway, Arlington, VA 22202, (703)-

305-5232.

There are presently no actions

pending against the continued

registration of this chemical.

Based on the information and data

considered, the Agency has determined

that the tolerances established by

amending 40 CFR part 180 will protect

the public health. Therefore, the

tolerances are 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

to the regulation and may also request

a hearing on those objections.

Objections and hearing requests must be

filed 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 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).

EPA has established a record for this

rulemaking under docket number [PP

2F4063/R2183] (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, except legal

holidays. The public record is located in

Rm. 1132 of the Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, Crystal Mall #2,
63960 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations

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, EPA

must judge whether a rule is ‘‘major’’

and therefore requires a Regulatory

Impact Analysis.

This rule was submitted to the Office

of Management and Budget (OMB) for

review as required by Executive Order

12866.

Under the Regulatory Flexibility Act

(5 U.S.C. 605(b)), EPA 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: October 26, 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 § 180.408, paragraph (a) is

amended by revising the introductory

text and by amending the table therein

by revising the entry for grasses, forage

and by adding and alphabetically

inserting a new entry for grass, hay, to

read as follows:

§ 180.408 Metalaxyl; tolerances for

residues.

(a) Tolerances are established for the

combined residues of the fungicide

metalaxyl [N-(2,6-dmethylphyenyl)-N-

(methoxyacetyl) alanine methylester]

and its metabolites containing the 2,6-

dimethylaniline moiety, and N-(2-

hydroxy methyl-6-methylphenyl)-N-

(methoxyacetyl)-alanine methyl ester,

each expressed as metalaxyl

equivalents, in or on the following raw

agricultural commodities:

Commodity Parts per

million

* * * * *

Grass, forage ............................ 10.0

Grass, hay ................................ 25.0

* * * * *

* * * * *

[FR Doc. 95–30116 Filed 12–12–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 8F3607/R2184; FRL–4985–3]

RIN 2070–AB78

Glufosinate Ammonium; Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes

time-limited tolerances for residues of

the herbicide glufosinate ammonium

(butanoic acid, 2-amino-4-

(hydroxymethylphosphinyl)-,

monoammonium salt) and its

metabolite, 3-methylphosphinicopropionic acid, in or on various raw

agricultural commodities (RAC’s).

AgrEvo USA Co. submitted a petition to

EPA under the Federal Food, Drug and

Cosmetic Act (FFDCA) requesting the

tolerances. The document also conforms

the chemical expression for the

herbicide to Chemical Abstract

nomenclature.

EFFECTIVE DATE: This regulation

becomes effective December 13, 1995.

The tolerances will expire on July 13,

1999.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 8F3607/

R2184], 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

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 8F3607/R2184].

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: Joanne I. Miller, Product Manager

(PM) 23, Registration Division (7505C),

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 237, CM #2, 1921 Jefferson Davis

Hwy., Arlington, VA 22202, (703)-305-

6224; e-mail:

miller.joanne@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of July 26, 1995 (60 FR

38334), EPA issued a notice announcing

that AgrEvo USA Co., Little Falls One,

2711 Centerville Rd., Wilmington, DE

19808, had submitted an amendment to

PP 8F3607 (published at 53 FR 18897,

May 25, 1988) proposing to amend 40

CFR 180.473 by adding tolerances for

residues of glufosinate ammonium and

its metabolite, 3-methylphosphinicopropionic acid, in or on the following

raw agricultural commodities: Tree nuts

group at 0.10 ppm, almond hulls at 0.50

ppm, cattle fat at 0.05 ppm, cattle meat

at 0.05 ppm, cattle meat byproducts

(mbyp) at 0.10 ppm, eggs at 0.05 ppm,