3796 Federal Register / Vol. 60, No. 12 / Thursday, January 19, 1995 / Proposed Rules

does not have a significant impact on

any small entities affected. Moreover,

due to the nature of the Federal-state

relationship under the CAA, preparation

of a regulatory flexibility analysis would

constitute Federal inquiry into the

economic reasonableness of state action.

The CAA forbids EPA to base its actions

concerning SIPs on such grounds.

Union Electric Co. v. U.S. E.P.A., 427

U.S. 246, 256–66 (S.Ct. 1976); 42 U.S.C.

7410(a)(2).

The OMB has exempted this action

from review under Executive Order

12866.

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Hydrocarbons,

Intergovernmental relations, Ozone,

Reporting and recordkeeping

requirements, Volatile organic

compound.

Authority: 42 U.S.C. 7401–7671q.

Dated: January 6, 1995.

Felicia Marcus,

Regional Administrator.

[FR Doc. 95–1318 Filed 1–18–95; 8:45 am]

BILLING CODE 6560–50–W

40 CFR Parts 152, 174, and 180

[OPP–300378; FRL–4932–6]

RIN 2070–AC02

Plant-Pesticides Subject to the Federal

Insecticide, Fungicide, and

Rodenticide Act; Proposed

Exemptions From the Requirement of

a Tolerance for Plant-Pesticides and

Nucleic Acids and Viral Coat Proteins

Produced in Plants under the Federal

Food, Drug, and Cosmetic Act;

Proposed Rules; Extension of

Comment Periods

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Extension of comment periods.

SUMMARY: EPA is extending the

comment period for a proposed rule for

plant-pesticides under the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA), and three proposed

exemptions from the requirement of a

tolerance under the Federal Food, Drug,

and Cosmetic Act (FFDCA). The

proposed rule and proposed exemptions

from tolerance requirements describe

how EPA proposes to address pesticidal

substances produced by plants under

FIFRA and FFDCA.

DATES: Comments identified by the

docket control numbers [OPP– 300367a,

300368a, 300369a, 300371a] must be

received on or before February 23, 1995.

ADDRESSES: Submit written comments

by mail to: Program Resources Section,

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Environmental Protection

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

DC 20460. In person, bring comments

to: Rm. 1132, Crystal Mall #2, 1921

Jefferson Davis Highway, Arlington, VA

22202.

FOR FURTHER INFORMATION CONTACT: By

mail: Bernice Slutsky, Science and

Policy Staff, Office of Prevention,

Pesticides and Toxic Substances (7101),

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. E–627, 401 M St., SW., Washington,

DC, (202–260–6900).

SUPPLEMENTARY INFORMATION: The

substances plants produce to protect

themselves against pests and disease are

considered to be pesticides under the

FIFRA definition of ‘‘pesticide.’’ These

substances, along with the genetic

material necessary to produce them are

designated ‘‘plant-pesticides’’ by EPA.

In the Federal Register of November 23,

1994, EPA published: (1) A proposed

policy statement that describes EPA’s

regulatory approach for plant-pesticides

under FIFRA and FFDCA (‘‘Proposed

Policy; Plant-Pesticides Subject to the

Federal Insecticide, Fungicide, and

Rodenticide Act and the Federal Food,

Drug, and Cosmetic Act’’) (59 FR

60496); (2) a proposed regulatory

amendment that would describe

categories of plant-pesticides that are

subject to or exempt from regulation

under FIFRA and clarifies the status of

plants that produce plant-pesticides

(‘‘Plant-Pesticides Subject to the Federal

Insecticide, Fungicide, and Rodenticide

Act; Proposed Rule’’) (59 FR 60519); (3)

a proposed exemption from the

requirement of a tolerance under

FFDCA for categories of plant-pesticides

that do not result in significantly

different dietary exposures (‘‘PlantPesticides; Proposed Exemption From

the Requirement of a Tolerance Under

the Federal Food, Drug, and Cosmetic

Act’’) (59 FR 60535); (4) a proposed

exemption from the requirement of a

tolerance under FFDCA for nucleic

acids, including deoxyribonucleic and

ribonucleic acids (‘‘Plant-Pesticides;

Proposed Exemption From the

Requirement of a Tolerance Under the

Federal Food, Drug, and Cosmetic Act

for Nucleic Acids Produced in Plants,’’)

(59 FR 60542); and (5) a proposed

exemption from the requirement of a

tolerance under FFDCA for viral coat

proteins (‘‘Plant-Pesticides; Proposed

Exemption From the Requirement of a

Tolerance Under the Federal Food,

Drug, and Cosmetic Act for Viral Coat

Proteins Produced in Plants’’) (59 FR

60545). In response to requests by

interested parties, EPA is extending the

comment period for the four proposals

by 30 days. Elsewhere in this issue of

the Federal Register, EPA is also

extending the comment period by 30

days for the proposed statement of

policy for pesticidal substances

produced in plants (plant-pesticides)

under FIFRA and FFDCA. Comments for

all documents must now be received by

February 23, 1995.

Comments must be filed with the

corresponding docket numbers:

Docket Number Document Name

OPP–300369a Plant-Pesticides Subject to the Federal Insecticide, Fungicide, and Rodenticide Act; Proposed Rule

OPP–300368a Plant-Pesticides; Proposed Exemption from the Requirement of a Tolerance Under the Federal Food,

Drug, and Cosmetic Act

OPP–300371a Plant-Pesticides; Proposed Exemption from the Requirement of a Tolerance Under the Federal Food,

Drug, and Cosmetic Act for Nucleic Acids Produced in Plants

OPP–300367a Plant-Pesticides; Proposed Exemption from the Requirement of a Tolerance Under the Federal Food,

Drug, and Cosmetic Act for Viral Coat Proteins Produced in Plants
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.