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,
Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations 63961

goat fat at 0.05 ppm, goat meat at 0.05

ppm, goat mbyp at 0.10 ppm, hog fat at

0.05 ppm, hog meat at 0.05 ppm, hog

mbyp at 0.10 ppm, horse fat at 0.05

ppm, horse meat at 0.05 ppm, horse

mbyp at 0.10 ppm, milk at 0.02 ppm,

poultry fat at 0.05 ppm, poultry meat at

0.05 ppm, poultry mbyp at 0.10 ppm,

sheep fat at 0.05 ppm, sheep meat at

0.05 ppm, and sheep mbyp at 0.10 ppm.

Almonds are not considered a poultry

feed commodity under present EPA

Guidelines, and AgrEvo USA Co. has

requested that the proposed tolerances

for secondary residues in eggs, poultry

fat, meat, and meat byproducts be

deleted from the tolerances requested.

This document also amends 40 CFR

180.473 to change the chemical

expression for the herbicide to that

given above in conformity with

Chemical Abstract nomenclature.

The chemical expression for

glufosinate ammonium has been

changed to follow that given by the

Chemical Abstracts Index Name for this

chemical. This action is taken in concert

with the final rule for Premanufacture

Notification; Revisions of

Premanufacture Notification

Regulations, published in the Federal

Register of March 29, 1995 (60 FR

16298-16310). The proposed analytical

method for determining residues is

high-pressure liquid chromatography.

There were no comments or requests

for referral to an advisory committee

received in response to the notice of

filing.

The data submitted in the petition

and other relevant material have been

evaluated. The toxicology data listed

below were considered in support of

these tolerances.

1. A battery of acute toxicity studies

placing technical glufosinateammonium in Toxicity Categories II and

III.

2. A 90-day feeding study in rats at

dietary intakes of 0, 0.52, 4.1, 32, or 263

mg/kg/day with a no-observed-effect

level (NOEL) of 4.1 mg/kg/day. The

lowest-observed-effect level (LOEL) was

established at 32 mg/kg/day based on

increased absolute and relative kidney

weights.

3. A 90-day feeding study in mice at

dietary intakes of 0, 16.6, 67.1, or 278

mg/kg/day with a NOEL of 16.6 mg/kg/

day and an LOEL of 67.1 mg/kg/day

based on increased absolute and relative

liver weights (both sexes) and an

increase in serum potassium levels

(males).

4. Three teratology studies in rats at

doses from 0.5 to 250 mg/kg/day with

no teratogenic effects occurring up to

and including 250 mg/kg/day. A NOEL

for developmental toxicity was 2.24 mg/

kg/day, based upon an increase in the

incidence of dilated renal pelvis with

hydroureter in the fetuses at 10 mg/kg/

day. The maternal NOEL was also 2.24

mg/kg/day.

5. A teratology study in rabbits at

doses of 0, 2, 6.3, or 20 mg/kg/day with

no teratogenic effects occurring up to

and including 20 mg/kg/day, and a

maternal NOEL of 6.3 mg/kg/day and a

developmental NOEL of 20 mg/kg/day,

the highest dose tested.

6. A two-generation reproduction

study in rats at dietary concentrations of

0, 40, 120, or 360 ppm with an NOEL

for reproductive effects at 120 ppm

(equivalent to 12 mg/kg/day) based

upon reduced number of pups in the

high-dose group. The NOEL for parental

toxicity was also 120 ppm based upon

increased kidney weights in the highdose group.

7. A 12-month feeding study in dogs

at doses of 0, 2, 5, or 8.5 mg/kg/day. The

NOEL was 5.0 mg/kg/day based upon

the death of one male and one female

dog at 8.5 mg/kg/day with no other

treatment-related toxicity.

8. A mouse carcinogenicity study at

doses of 0, 2.8, 10.8, or 22.7 mg/kg/day

in males and 0, 4.2, 16.2, or 64.0 mg/kg/

day in females for 104 weeks with no

carcinogenic effects observed under the

conditions of the study up to and

including 64 mg/kg/day and a systemic

NOEL of 10.8 and 16.2 for males and

females, respectively, based on the doserelated increase in mortality.

9. A chronic feeding/carcinogenicity

study in rats at dietary doses of 0, 2.5,

8.8, or 31.5 mg/kg/day (males) and 0,

2.4, 8.2, or 28.7 mg/kg/day (females)

with an NOEL of 2.1 mg/kg/day for

systemic effects based on an increase in

mortality rate in females at the two

higher doses. There were no treatmentrelated carcinogenic effects at any dose

level.

10. Acceptable studies on gene

mutation (Salmonella, E coli., and

mouse lymphoma assays), structural

chromosomal aberration (in vivo

micronucleus assay in mice), and other

genotoxic effects (unscheduled DNA

synthesis assay with rat hepatocytes)

yielded negative results.

11. Pharmacokinetic and metabolism

studies in rats indicated that

approximately 80 to 90 percent of the

orally administered dose of glufosinate

ammonium remained unabsorbed and

was eliminated in the feces.

Approximately 10 to 15 percent was

eliminated in the urine. The major

metabolic pathway is oxidative

deamination yielding the metabolite, 3-

methyl-phospinico propionic acid.

The chronic analysis used a Reference

Dose (RfD) of 0.02 mg/kg/ body weight

day, based on an NOEL of 2.1 mg/kg/

day and an uncertainty factor of 100.

The NOEL is based on a 2-year rat

feeding study that demonstrated

increased absolute and relative kidney

weight in males as an endpoint effect.

Using tolerance-level residues and

assumptions that 100 percent of every

crop for which glufosinate-ammonium

has a proposed use is treated, the total

Theoretical Maximum Residue

Contribution (TMRC) for the general

population and the highest exposed

subgroup in DRES are as follows (as

percents of RFD): General population,

0.627 percent; nonnursing infants less

than 1-year-old, 3.7 percent.

A data gap currently exists for a rat

carcinogenicity study. All tolerances are

time-limited because of this gap. The

time limitation allows for development

and review of the data.

The analysis for glufosinateammonium using tolerance level

residues suggests that the proposed uses

on apples, grapes, and tree nut group

will not cause exposure to exceed the

levels at which the Agency believes

there is an appreciable risk. All DRES

subgroups are below 100 of the RfD for

chronic effects.

The pesticide is useful for the

purposes for which these tolerances are

sought. The nature of the residues is

adequately understood for the purpose

of establishing these tolerances.

Adequate analytical methodology (gas

chromatography with flame photometric

detection of phosphorus) is available for

enforcement purposes. Because of the

long lead time from establishing these

tolerances to publication, the

enforcement methodology is being made

available in the interim to anyone

interested in pesticide enforcement

when requested by mail from: Calvin

Furlow, Public Response 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. 1130A, CM

#2, 1921 Jefferson Davis Hwy.,

Arlington, VA 22202, (703)-305-5937.

Based on the information cited above,

the Agency has determined that the

establishment of the time-limited

tolerances by amending 40 CFR 180.473

will protect the public health; therefore,

the time-limited 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

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
63962 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations

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

8F3607/R2184] (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 8F3607/R2184],

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

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 30, 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. In § 180.473, by revising paragraph

(a), to read as follows:

§ 180.473 Glufosinate ammonium;

tolerances for residues.

(a)(1) Time-limited tolerances are

established for residues of the herbicide

glufosinate ammonium (butanoic acid,

2-amino-4-(hydroxymethylphosphinyl)-,

monoammonium salt) and its

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

raw agricultural commodities:

Commodity Parts per

million

Expiration

date

Almond hulls ..... 0.50 July 13,

1999

Apples ............... 0.05 Do.

Cattle, fat .......... 0.05 Do.

Cattle, meat ...... 0.05 Do.

Cattle, mbyp ..... 0.10 Do.

Goats, fat .......... 0.05 Do.

Goats, meat ...... 0.05 Do.

Goats, mbyp ..... 0.10 Do.

Grapes .............. 0.05 Do.

Hogs, fat ........... 0.05 Do.

Hogs, meat ....... 0.05 Do.

Hogs, mbyp ...... 0.10 Do.

Horses, fat ........ 0.05 Do.

Horses, meat .... 0.05 Do.

Horses, mbyp ... 0.10 Do.

Milk ................... 0.02 Do.

Sheep, fat ......... 0.05 Do.

Sheep, meat ..... 0.05 Do.

Sheep, mbyp .... 0.10 Do.

Tree nuts group 0.1 Do.

(2) Residues in these commodities not

in excess of the established tolerances

resulting from the uses described in

paragraph (a)(1) of this section

remaining after expiration of the timelimited tolerance will not be considered

to be actionable if the herbicide is

applied during the term of and in

accordance with the provisions of

paragraph (a)(1) of this section.

* * * * *

[FR Doc. 95–30117 Filed 12–12–95; 8:45 am]

BILLING CODE 6560–50–F