Federal Register / Vol. 60, No. 55 / Wednesday, March 22, 1995 / Proposed Rules 15109

IV of the Act, and Utah commits to

adopt the rules and requirements

promulgated by EPA to implement an

acid rain program through the title V

permit.

B. Proposed Action

EPA is proposing full approval of the

operating permits program submitted to

EPA by the State of Utah on April 14,

1994. Among other things, Utah has

demonstrated that the PROGRAM will

be adequate to meet the minimum

elements of a State operating permits

program as specified in 40 CFR part 70.

EPA also proposes approval of the Utah

Construction Permit Program found in

section R307–1–3 of the State’s

regulations under section 112(l) of the

Act for the purpose of creating Federally

enforceable permit conditions for

sources of hazardous air pollutants

listed pursuant to section 112(b) of the

Act, and, under the authority of title V

and 40 CFR part 70, for the purpose of

providing a mechanism to implement

section 112(g) of the Act during any

transition period between EPA’s

promulgation of a section 112(g) rule

and adoption by the State of rules to

implement section 112(g).

In Utah’s part 70 program submission,

the State indicated that it is not seeking

approval from EPA to administer the

State’s part 70 PROGRAM within the

exterior boundaries of Indian

Reservations in Utah. In this notice,

EPA proposes to approve Utah’s part 70

PROGRAM for all areas within the State

except the following: lands within the

exterior boundaries of Indian

Reservations (including the Uintah and

Ouray, Skull Valley, Paiute, Navajo,

Goshute, White Mesa, and Northwestern

Shoshoni Indian Reservations) and any

other areas which are ‘‘Indian Country’’

within the meaning of 18 U.S.C. 1151

(excepted areas).

In proposing not to extend the scope

of Utah’s part 70 PROGRAM to sources

located in the excepted areas, EPA is not

making a determination that the State

either has adequate jurisdiction or lacks

jurisdiction over such sources. Should

the State of Utah choose to seek program

approval within these areas, it may do

so without prejudice. Before EPA would

approve the State’s part 70 PROGRAM

for any portion of the excepted areas,

EPA would have to be satisfied that the

State has authority, either pursuant to

explicit Congressional authorization or

applicable principles of Federal Indian

law, to enforce its laws against existing

and potential pollution sources within

any geographical area for which it seeks

program approval and that such

approval would constitute sound

administrative practice.

Requirements for approval, specified

in 40 CFR 70.4(b), encompass section

112(l)(5) requirements for approval of a

program for delegation of section 112

standards as promulgated by EPA as

they apply to part 70 sources. Section

112(l)(5) requires that the State’s

program contain adequate authorities,

adequate resources for implementation,

and an expeditious compliance

schedule, which are also requirements

under part 70. Therefore, EPA is also

proposing to grant approval under

section 112(l)(5) and 40 CFR part 63.91

of the State’s program for receiving

delegation of section 112 standards that

are unchanged from Federal standards

as promulgated. This program for

delegations applies to sources covered

by the part 70 program, as well as nonpart 70 sources.

III. Administrative Requirements

A. Request for Public Comments

The EPA is requesting comments on

all aspects of this proposed full

approval. Copies of the State’s submittal

and other information relied upon for

the proposed title V and section 112(l)

approvals are contained in a docket

maintained at the EPA Regional Office.

The docket is an organized and

complete file of all the information

submitted to, or otherwise considered

by, EPA in the development of these

proposed approvals. The principal

purposes of the docket are:

(1) to allow interested parties a means

to identify and locate documents so that

they can effectively participate in the

approval process, and

(2) to serve as the record in case of

judicial review. The EPA will consider

any comments received by April 21,

1995.

B. Executive Order 12866

The Office of Management and Budget

has exempted this action from Executive

Order 12866 review.

C. Regulatory Flexibility Act

EPA’s actions under section 502 and

section 112(l) of the Act do not create

any new requirements, but simply

address operating permits programs

submitted to satisfy the requirements of

40 CFR part 70 and the creation of

Federally enforceable permit conditions

for sources of hazardous air pollutants

listed pursuant to section 112(b) of the

Act. Because this action does not

impose any new requirements, it does

not have a significant impact on a

substantial number of small entities.

List of Subjects in 40 CFR Part 70

Environmental protection,

Administrative practice and procedure,

Air pollution control, Intergovernmental

relations, Operating permits, Reporting

and recordkeeping requirements.

Authority: 42 U.S.C. sections 7401–7671q.

Dated: March 14, 1995.

William P. Yellowtail,

Regional Administrator.

[FR Doc. 95–7063 Filed 3–21–95; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 180

[PP 3E4241/P607; FRL–4941–1]

RIN 2070–AC18

Imazethapyr; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish

tolerances with regional registration for

the sum of the residues of the herbicide

imazethapyr, as its ammonium salt, and

its metabolite in or on the raw

agricultural commodities lettuce and

endive. The Interregional Research

Project No. 4 (IR–4) requested this

proposed regulation.

DATES: Comments, identified by the

document control number, [PP 3E4241/

P607], must be received on or before

April 21, 1995.

ADDRESSES: By mail, submit written

comments 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

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 as

‘‘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: Hoyt L. Jamerson, Registration

Division (7505W), Office of Pesticide

Programs, Environmental Protection
15110 Federal Register / Vol. 60, No. 55 / Wednesday, March 22, 1995 / Proposed Rules

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

DC 20460. Office location and telephone

number: Sixth Floor, Crystal Station #1,

2800 Jefferson Davis Hwy., Arlington,

VA 22202, (703)-308-8783.

SUPPLEMENTARY INFORMATION: The

Interregional Research Project No. 4 (IR–

4), New Jersey Agricultural Experiment

Station, P.O. Box 231, Rutgers

University, New Brunswick, NJ 08903,

has submitted pesticide petition (PP)

3E4241 to EPA on behalf of the

vegetable growers of Florida. The

petition requests that the Administrator,

pursuant to section 408(e) of the Federal

Food, Drug, and Cosmetic Act (FFDCA),

21 U.S.C. 346a(e), amend 40 CFR

180.447 by establishing tolerances with

regional registration for residues of the

herbicide imazethapyr, 2-[4,5-dihydro4-methyl-4-(1-methylethyl)-5-oxo-1Himidazol-2-yl]-5-ethyl-3-pyridine

carboxylic acid, as its ammonium salt,

and its metabolite, 2-[4,5-dihydro-4-

methyl-4-(1-methylethyl)-5-oxo-1Himidazol-2-yl]-5-(1-hydroxyethyl-3-

pyridine carboxylic acid), free and

conjugated, in or on the raw agricultural

commodities lettuce (head and leaf) and

endive (escarole) at 0.1 part per million

(ppm). The petitioner proposed that use

of imazethapyr on lettuce and endive be

limited to Florida based on the

geographical representation of the

residue data submitted. Additional

residue data will be required to expand

the area of usage. Persons seeking

geographically broader registration

should contact the Agency’s

Registration Division at the address

provided above.

The scientific data submitted in the

petition and other relevant material

have been evaluated. The toxicological

data considered in support of the

proposed tolerances include:

1. Several acute toxicology studies

placing technical-grade imazethapyr in

Toxicity Category III and Toxicity

Category IV.

2. A 1-year feeding study with dogs

fed diets containing 0, 1,000, 5,000, or

10,000 part per million (ppm) with a

systemic no-observed-effect level

(NOEL) of 1,000 ppm (25 milligrams

(mg)/kilogram (kg)/day) based on

decreased packed cell volume,

hemoglobin, and erythrocytes in the

blood of female dogs at the 5,000-ppm

(125 mg/kg/day) dose level.

3. A 78-week carcinogenicity study in

mice fed diets containing 0, 1,000, 5,000

or 10,000 ppm (equivalent to 0, 150,

750, or 1,500 mg/kg/day) with a

systemic NOEL of 5,000 ppm based on

decreased body weight gain in both

sexes at the 10,000-ppm dose level. No

carcinogenic effects were observed

under the conditions of the study.

4. A 2-year chronic feeding/

carcinogenicity study in rats fed diets

containing 0, 1,000, 5,000, or 10,000

ppm (equivalent to 0, 50, 250, or 500

mg/kg/day) with no treatment-related

systemic or carcinogenic effects

observed under the conditions of the

study.

5. A multi-generation reproduction

study in rats fed diets containing 0,

1,000, 5,000, or 10,000 ppm (equivalent

to 0, 50, 250, or 500 mg/kg/day) with no

treatment-related systemic or

reproductive effects observed under the

conditions of the study.

6. Developmental toxicity studies in

rats and rabbits with no developmental

toxicity observed under the conditions

of the studies at dose levels up to and

including the highest dose tested (1,125

mg/kg/day in rats and 1,000 mg/kg/day

in rabbits).

7. Mutagenicity studies include gene

mutation assays in bacteria cells

(negative) and Chinese hamster ovary

cells (no dose-response); structural

chromosomal aberration assays in vivo

in rat bone marrow cells (negative) and

in vitro in Chinese hamster ovary cells

(positive without activation at levels

toxic to cells and negative with

activation); and other genotoxic effects

(did not induce unscheduled DNA

synthesis in rat hepatocytes cultured in

vitro).

The reference dose (RfD) for

imazethapyr is established at 0.25 mg/

kg body weight/day. The RfD is based

on a NOEL of 25 mg/kg/day established

in the 1-year feeding study in dogs and

an uncertainty factor of 100. The

theoretical maximum residue

contribution (TMRC) from existing uses

and the proposed uses on lettuce and

endive utilizes less than 1 percent of the

RfD for the general population and all

22 subgroup populations for which EPA

routinely conducts dietary risk

assessments. This is a worst-case

estimate of dietary exposure which

assumes tolerance level residues and

treatment of the total production acreage

of the commodities. The dietary risk

assessment indicates that there is

minimal risk from the establishment of

the proposed tolerances for lettuce and

endive.

The nature of residues in lettuce and

endive is adequately understood for the

purposes of establishing the proposed

tolerances. An adequate analytical

method is available for enforcement

purposes. The enforcement

methodology has been submitted to the

Food and Drug Administration for

publication in the Pesticide Analytical

Manual, Vol. 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 Divisions (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 Hwy.,

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

No secondary residues are expected to

occur in meat, milk, poultry, or eggs

from this action since lettuce and

endive are not considered livestock feed

commodities.

There are currently 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 180.447 would

protect the public health. Therefore, it is

proposed that the tolerances be

established as set forth below.

Any person who has registered or

submitted an application for registration

of a pesticide, under the Federal

Insecticide, Fungicide, and Rodenticide

Act (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 section

408(e) of the FFDCA.

Interested persons are invited to

submit written comments on the

proposed regulation. Comments must

bear a notation indicating the document

control number, [PP 3E4241/P607]. All

written comments filed in response to

this petition will be available in the

Public Response and Program Resources

Branch, at the address given above from

8 a.m. to 4 p.m., Monday through

Friday, except legal holidays.

Under Executive Order 12866 (58 FR

51735, Oct. 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
Federal Register / Vol. 60, No. 55 / Wednesday, March 22, 1995 / Proposed Rules 15111

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: March 8, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, it is proposed that 40 CFR

part 180 be 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 § 180.447, by adding new

paragraph (d), to read as follows:

§ 180.447 Imazethapyr, ammonium salt;

tolerance for residues.

* * * * *

(d) Tolerances with regional

registration, as defined in § 180.1(n) of

this chapter, are established for the sum

of residues of the herbicide

imazethapyr, 2-[4,5-dihydro-4-methyl-4-

(1-methylethyl)-5-oxo-1H-imidazol-2-

yl]-5-ethyl-3-pyridine carboxylic acid,

as its ammonium salt, and its

metabolite, 2-[4,5-dihydro-4-methyl-4-

(1-methylethyl)-5-oxo-1H-imidazol-2-

yl]-5-(1-hydroxyethyl)-3-pyridine

carboxylic acid, both free and

conjugated, in or on the following raw

agricultural commodities:

Commodity Parts per

million

Endive (escarole) ...................... 0.1

Lettuce (head and leaf) ............ 0.1

[FR Doc. 95–6932 Filed 3–21–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[OPP–300380; FRL–4936–4]

RIN 2070–AC18

Acetic Acid Ethenyl Ester, Polymer

with Ethenol and (α)-2-Propenyl-(ω)-

Hydroxypoly(Oxy-1,2-Ethanediyl);

Tolerance Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This document proposes to

establish an exemption from the

requirement of a tolerance for residues

of acetic acid ethenyl ester, polymer

with ethenol and (α)-2-propenyl-(ω)-

hydroxypoly(oxy-1,2-ethanediyl) (CAS

Reg. No. 137091–12–4), when used as

an inert ingredient (component of watersoluble film) in pesticide formulations

applied to growing crops only under 40

CFR 180.1001(d). Japan Technical

Information Center, Inc., requested this

proposed regulation on behalf of

Nippon Gohsei (U.S.A.) Co., Ltd.

DATES: Written comments, identified by

the document control number, [OPP–

300380], must be received on or before

April 21, 1995.

ADDRESSES: By mail, submit written

comments 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

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 as

‘‘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

will be included in the public docket 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:

Kerry Leifer, Registration Support

Branch, Registration Division (7505W),

Environmental Protection Agency, 401

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

Office location and telephone number:

2800 Crystal Drive, North Tower, 6th

Floor, Arlington, VA 22202, (703) 308–

8323.

SUPPLEMENTARY INFORMATION: Japan

Information Center, Inc., 775 South 23rd

St., Arlington, VA 22202, on behalf of

Nippon Gohsei (U.S.A.) Co., Ltd.,

submitted pesticide petition (PP)

4EO4403 to EPA requesting that the

Administrator, pursuant to section

408(e) of the Federal Food Drug, and

Cosmetic Act (FFDCA) (21 U.S.C.

346a(e)), propose to amend 40 CFR

180.1001(d) by establishing an

exemption from the requirement of a

tolerance for residues of acetic acid

ethenyl ester, polymer with ethenol and

(α)-2-propenyl-(ω)-hydroxypoly(oxy-1,2-

ethanediyl) (CAS Reg. No. 137091–12–

4), when used as an inert ingredient

(component of water-soluble film) in

pesticide formulations applied to

growing crops only under 40 CFR

180.1001(d).

Inert ingredients are all ingredients

that are not active ingredients as defined

in 40 CFR 153.125, and include, but are

not limited to, the following types of

ingredients (except when they have a

pesticidal efficacy of their own):

solvents such as alcohols and

hydrocarbons; surfactants such as

polyoxyethylene polymers and fatty

acids; carriers such as clay and

diatomaceous earth; thickeners such as

carrageenan and modified cellulose;

wetting, spreading, and dispersing

agents; propellants in aerosol

dispensers; microencapsulating agents;

and emulsifiers. The term ‘‘inert’’ is not

intended to imply nontoxicity; the

ingredient may or may not be

chemically active.

The data submitted in the petition

and other relevant material have been

evaluated. As part of the EPA policy

statement on inert ingredients published

in the Federal Register of April 22, 1987

(52 FR 13305), the Agency set forth a list

of studies which would generally be

used to evaluate the risks posed by the

presence of an inert ingredient in a

pesticide formulation. However, where

it can be determined without that data

that the inert ingredient will present

minimal or no risk, the Agency

generally does not require some or all of

the listed studies to rule on the

proposed tolerance or exemption from

the requirement of a tolerance for an