Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Proposed Rules 3797

List of Subjects in 40 CFR Parts 152,

174, and 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities,

Biotechnology pesticides, Pesticides and

pests, Plants, Plant-pesticides, Reporting

and recordkeeping requirements.

Dated: January 12, 1995.

Lynn R. Goldman,

Assistant Administrator for Prevention,

Pesticides and Toxic Substances.

[FR Doc. 95–1319 Filed 1–18–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 4E4349/P599; FRL–4932–9]

RIN 2070–AC18

Pesticide Tolerance for Amitraz

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish a

tolerance for residues of the insecticide/

miticide amitraz and its metabolites in

or on imported dried hops at 60 parts

per million (ppm). AgrEvo (formerly

Nor Am) Chemical Co. requested this

regulation to establish the maximum

permissible level of residues of the

insecticide/miticide in or on the

commodity.

DATE: Comments, identified by the

document control number [PP 4E4349/

P599], must be received on or before

February 21, 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 20460. In person, bring

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

Jefferson Davis Hwy., 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 above, 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: EPA

issued a notice, published in the

Federal Register of December 13, 1991

(56 FR 65080), which announced that

Nor-Am Chemical Co., Little Falls

Centre One, 2711 Centerville Rd.,

Wilmington, DE 19808, had submitted a

food additive petition (FAP 2H5618) to

EPA requesting that the Administrator,

pursuant to sections 408(d) and 409 of

the Federal Food, Drug, and Cosmetic

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

348, establish a tolerance for the

insecticide/miticide amitraz (N’-[2,4-

dimethylphenyl]-N-[[(2,4-

dimethylphenyl)imino]methyl]]-Nmethylmethanimidamide) and its

metabolites N-(2,4-dimethylphenyl)-Nmethyl formamide and N-(2,4-

dimethylphenyl)-Nmethylmethanimidamide (both

calculated as the parent compound) in

or on imported dried hops at 75 parts

per million. There were no comments

received in response to the initial notice

of filing.

In the Federal Register of May 17,

1994 (59 FR 25586), the Agency issued

a proposal to establish the amitraz hops

tolerance at 75 ppm. No comments were

received in response to this proposal;

however, a concern was raised regarding

the potential acute dietary risk of

amitraz posed by its registered uses

during reregistration under the Federal

Insecticide, Fungicide, and Rodenticide

Act, 7 U.S.C. 136 et seq., and therefore

the final rule was not published. To

address this concern, the company

provided a voluntary human study and

additional residue data and proposed a

lower tolerance of 50 ppm for hops. An

Agency review of the data concluded

that a tolerance of 60 ppm is needed

given the existing application rates.

EPA had not proposed to establish a

tolerance for amitraz on hops in the past

because dried hops have been

considered a processed food requiring a

section 409 tolerance and EPA was

concerned that a section 409 tolerance

for amitraz might be prohibited by the

section 409 Delaney anti-cancer clause.

Recently, EPA reclassified dried hops as

a raw agricultural commodity (see

proposed rule at 59 FR 25586; May 17,

1994).

The data submitted in the petition

and all other relevant material have

been evaluated. The toxicology data

considered in support of the tolerance

was described in the May 17, 1994

proposed rule. In June 1994, a voluntary

human study was submitted. This study

indicated changes in systolic blood

pressure, body temperature, ECG rate,

and psychomotor performance observed

from a single oral dose at the 0.125 mg/

kg (the NOEL) level to be minimal and

transient.

As directed by FIFRA section

4(g)(2)(A), the database for amitraz has

undergone a reevaluation and

reassessment as part of the reregistration

process. It was determined that a

combined developmental, neurological,

and reproduction toxicity study in rats

is needed to provide confirmatory data.

The amitraz Reregistration Eligibility

Document (RED), which is expected to

be released shortly, will require this

study.

The nature of the residue in plants

and livestock is adequately understood.

The residues of concern are amitraz and

its metabolites containing the 2,4-

dimethylaniline moiety. The residue

analytical method is a common moiety

method which converts amitraz and its

two metabolites to 2,4-dimethylaniline

with determination of the residues by

gas chromatography using 63Ni electron

detection. The method has been

published in FDA’s PAM II. Magnitude

of the residue data show that total

amitraz residues on dried hops are not

expected to exceed the proposed

tolerance when amitraz is used as

directed. There are currently no actions

pending against continued registration

of this chemical.

The Agency has prepared a dietary

risk assessment for the amitraz RED,

which is expected to be released shortly.

Amitraz is a possible human carcinogen

based on a 2-year mouse carcinogenicity

study. The current dietary risk

determined during preparation of the

RED was calculated to be 1.4 X 10-6 (for

the cottonseed/eggs/poultry use, plus

pears, cattle, swine, and honey/

beeswax). The addition of the use on

hops will add 1.2 X 10-6 to this risk,

assuming exposure over a lifetime of 70

years for a total lifetime dietary cancer

risk from exposure to amitraz residues

of 2.6 X 10-6. The use of amitraz on

imported hops is expected to still keep

the overall lifetime dietary cancer risk

within the negligible range.

The anticipated residue contribution

(ARC) for this chemical from published

tolerances utilizes 1 percent of the

reference dose (RfD). The proposed

tolerance will contribute 0.000025 mg/

kg/bwt/day utilizing an additional 1

percent of the RfD. This results in a total

utilization of 2 percent of the RfD.
3798 Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Proposed Rules

As stated previously, the May 17,

1994 proposed rule to establish a

tolerance for amitraz in/on imported

hops was not finalized because the

amitraz reregistration activities

indicated the potential for an acute risk

of concern. Using the voluntary human

study submitted by the company, a

revised dietary exposure analysis was

performed assessing the acute risk from

the proposed use of amitraz on dried

hops. Acute exposure from beer was

calculated by multiplying individual,

single day consumption estimates taken

from the USDA’s 1977-1978 Nationwide

Food Consumption Survey by a residue

of 0.22 ppm to derive a distribution of

acute exposures for the two subgroups

previously identified as being most

highly exposed to amitraz through beer,

‘‘Males 13 years and older’’ and

‘‘Females 13 years and older.’’ Because

hops are mixed as part of the brewing

process, a residue value in beer

reflecting the average residue in hops

was deemed more appropriate than

using a residue value in beer based on

the tolerance on hops.

The Margin of Exposure (MOE) is a

measure of how closely exposure comes

to the NOEL (the highest dose at which

no effects were observed in the study),

and is calculated as the ratio of the

NOEL to the exposure (NOEL/exposure

= MOE). The Agency normally

considers an MOE of 10 or greater

acceptable when the NOEL is based on

a human study. MOEs at the 99th

percentile from amitraz in beer were 10

for ‘‘Males, 13 +’’ and 15 for ‘‘Females,

13 +’’. Only those consumers within

both subgroups having consumption

greater than the 99th percentile

consumer would have MOEs for beer

which are below 10. Additionally, the

acute risk assessment assumed that 100

percent of all imported beer and 100

percent of all imported hops used in

domestic beer production would

contain amitraz. The Agency considers

this to be extremely unlikely.

The Agency expects a brewing study

providing additional residue data to be

submitted which may enable further

refinement and reevaluation of the risk.

At this time, no residue data supporting

domestic use have been submitted for

the U.S., and there are no U.S.

registrations for the use of amitraz on

hops. The Agency will not consider any

applications for registration of amitraz

to be used on hops in the U.S., nor will

EPA consider any Special Local Needs

Registrations (FIFRA section 24(c)) until

acceptable U.S. residue data are

submitted and reviewed and a risk/

benefit analysis is performed.

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 that this

rulemaking proposal be referred to an

Advisory Committee in accordance with

FFDCA section 408(e).

Interested persons are invited to

submit written comments on the

proposed regulation. Comments must

bear a notation indicating the document

control number, [PP 4E4349/P599]. All

written comments filed in response to

this petition will be available in the

Public Docket and Freedom of

Information Section, at the address

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 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

Administrative practice and

procedure, Agricultural commodities,

Pesticides and pests, Recording and

recordkeeping requirements.

Dated: January 12, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, it is proposed that 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 § 180.287, by amending the table

therein by adding and alphabetically

inserting the raw agricultural

commodity dried hops, to read as

follows:

§ 180.287 Amitraz; tolerances for residues.

* * * * *

Commodity Parts per

million

* * * * *

Hops, dried ............................... 60

* * * * *

[FR Doc. 95–1320 Filed 1–18–95; 8:45 am]

BILLING CODE 6560–50–F

LEGAL SERVICES CORPORATION

45 CFR Part 1611

Eligibility

AGENCY: Legal Services Corporation.

ACTION: Proposed rule.

SUMMARY: The Legal Services

Corporation (‘‘LSC’’ or ‘‘Corporation’’)

proposes to amend regulations relating

to eligibility for LSC-funded legal

services. This regulation has been

substantially revised and reordered, in

part to simplify the regulation and

clarify current Corporation policy and

in part to revise Corporation policy,

particularly with respect to access by

LSC to client records.

DATES: Comments may be submitted on

or before March 20, 1995.

ADDRESSES: Comments may be

submitted to the Office of General

Counsel, Legal Services Corporation,

750 First St., NE., 11th Floor,

Washington, DC 20002–4250.

FOR FURTHER INFORMATION CONTACT:

Victor Fortuno, General Counsel, (202)

336–8810.

SUPPLEMENTARY INFORMATION: The

Operations and Regulations Committee

of the LSC Board (‘‘Committee’’) held

public hearings on June 20, 1994, and

September 17, 1994, in Washington, DC,

to consider a draft of proposed revisions

to 45 CFR part 1611, LSC’s regulations

on eligibility for LSC-funded legal

assistance. At a meeting in Washington,

DC, on October 28, 1994, the Committee

approved a draft to be published in the

Federal Register as a proposed rule for

public comment.

Under this proposal, part 1611 has

been substantially revised and reordered

to make the regulation less complex and

easier for recipients to apply. While

there are numerous proposals for

substantive change, the majority of the

revisions reflect the Committee’s desire

to make this rule more comprehensible

and less subject to confusion and

misinterpretation than is the current

regulation. Throughout the rule, there

are slight changes in language to clarify

the rule or to make it consistent with