Federal Register / Vol. 61, No. 119 / Wednesday, June 19, 1996 / Proposed Rules 31075

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 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 notice 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 docket

number [PP 2E4042/P661].

A record has been established for this

rulemaking under docket number [PP

2E4042/P661] (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, 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.

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 Virginia

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

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

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 t his

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.

This action does not impose any

enforceable duty, or contain any

‘‘unfunded mandates’’ as described in

Title II of the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104–4), or

require prior consultation as specified

by Executive Order 12875 (58 FR 58093,

October 28, 1993), entitled Enhancing

the Intergovernmental Partnership, or

special consideration as required by

Executive Order 12898 (59 FR 7629,

February 16, 1994).

Pursuant to the requirements of the

Regulatory Flexibility Act (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 explaing the

factual basis for this determination 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: June 4, 1996.

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 § 180.275, the table in paragraph

(a) is amended by adding alphabetically

the raw agricultural commodity

asparagus, to read as follows:

§ 180.275 Chlorothalonil; tolerances for

residues.

(a) * * *

Commodity Parts per

million

* * * * *

Asparagus ................................. 0.10

* * * * *

* * * * *

[FR Doc. 96–15478 Filed 6–18–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 6E4653/P665; FRL–5377–4]

RIN 2070–AC18

Sodium Salt of Fomesafen; Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish a

time-limited tolerance for residues of

the herbicide sodium salt of fomesafen

(also referred to in this document as

fomesafen) in or on the raw agricultural

commodity snap beans. The proposed

regulation to establish a maximum

permissible level for residues of the

herbicide was requested in a petition

submitted by the Interregional Research

Project No. 4 (IR-4).

DATES: Comments, identified by the

docket number [PP 6E4653/P665], must

be received on or before July 19, 1996.

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 Highway, Arlington, VA

22202.

Comments and data may also be

submitted to OPP by sending electronic

mail (e-mail) to:

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. Comments and data will

also be accepted on disks in

WordPerfect 5.1 file format or ASCII file

format. All comments and data in

electronic form must be identified by

the docket number [PP 6E4653/P665].

Electronic comments on this proposed

rule may be filed online at many Federal

Depository Libraries. Additional
31076 Federal Register / Vol. 61, No. 119 / Wednesday, June 19, 1996 / Proposed Rules

information on electronic submissions

can be found in the

‘‘SUPPLEMENTARY INFORMATION’’

section of this document.

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). CBI should not be submitted

through e-mail. Information marked as

CBI 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 4:30 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

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

20460. Office location and telephone

number: Sixth Floor, Crystal Station #1,

2800 Jefferson Davis Highway,

Arlington, VA 22202, (703) 308–8783; email: jamerson.hoyt@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: The

Interregional Research Project No. 4 (IR4), New Jersey Agricultural Experiment

Station, P.O. Box 231, Rutgers

University, New Brunswick, NJ 08903,

has submitted pesticide petition (PP)

6E4653 to EPA on behalf of the

Agricultural Experiment Stations of

Arkansas, Georgia, Kentucky,

Minnesota, New York, North Carolina,

Tennessee, and Virginia.

This 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 180.433 by

establishing a time-limited tolerance for

residues of the sodium salt of

fomesafen, 5-[2-chloro-4-

(trifluoromethyl)phenoxy]-N-

(methylsulfonyl)-2-nitrobenzamide, in

or on the raw agricultural commodity

snap beans at 0.05 parts per million

(ppm). IR-4 proposed that registration

for use of fomesafen on snap beans be

geographically limited to the following

states: Alabama, Arkansas, Delaware,

Georgia, Indiana, Illinois, Iowa, Kansas,

Kentucky, Louisiana, Maine, Maryland,

Massachusetts, Michigan, Minnesota,

Missouri, Mississippi, Nebraska, New

Hampshire, New Jersey, New York,

North Carolina, Oklahoma, Ohio,

Pennsylvania, Rhode Island, South

Carolina, Tennessee, Texas, Vermont,

Virginia, West Virginia, and Wisconsin.

Additional geographical restrictions,

within these states, will be specified on

the pesticide label.

EPA is proposing to establish this

tolerance with an expiration date of

December 31, 1998, to allow IR-4 time

to conduct additional residue field trials

in support of a permanent tolerance for

regional registration for use of

fomesafen on snap beans. The available

residue data show no-detectable

residues (less than 0.05 ppm) on snap

beans from the proposed use pattern.

The requested residue field trials are

expected to provide confirmatory data

in support of a permanent tolerance for

residues of fomesafen on snap beans at

0.05 ppm.

The scientific data submitted in the

petition and other relevant material

have been evaluated. The toxicological

data considered in support of the

proposed tolerance include:

(1) A 6–month feeding study in dogs

fed diets containing 0, 0.1, 1.0 or 25 mg/

kg/day with a no-observed-effect level

(NOEL) of 1.0 mg/kg/day. Dogs fed 25

mg/kg/day demonstrated altered lipid

metabolism and liver change.

(2) A 2–year feeding/carcinogenicity

study with rats fed diets containing 0,

5, 100, or 1,000 ppm with a NOEL for

systemic effects of 5 ppm (0.25 mg/kg/

day). At the lowest-effect level (LEL)

100 ppm (5 mg/kg/day) there was liver

toxicity and decreased body weight.

There were no carcinogenic effects

observed under the conditions of the

study.

(3) A 2–year feeding/carcinogenicity

study with mice fed diets containing 0,

1, 10, 100, or 1,000 ppm (equivalent to

0.15, 1.5, 15, or 150 mg/kg/day) with

statistically significant increases in the

incidences of liver adenomas in male

mice at 1, 100, and 1,000 ppm and in

female mice at 100 and 1,000 ppm, and

statistically significant increases in the

incidences of liver carcinomas and

combined liver carcinomas and

adenomas in both sexes at 1,000 ppm.

(4) A 2–generation reproduction study

in rats fed diets containing 0, 50, 250,

or 1,000 ppm (equivalent to 2.5, 12.5, or

50 mg/kg/day) with no reproductive

effects observed. The NOEL for systemic

toxicity (reduction in body weight and

liver necrosis) is established at 250 ppm

for this study.

(5) A developmental toxicity study in

rats given oral doses of 0, 50, 100, or 200

mg/kg/day on gestation days 6 to 15

with no developmental toxicity.

(6) A developmental toxicity study in

rabbits given oral doses of 0, 2.5, 10, or

40 mg/kg/day on gestation days 6 to 18

with no developmental toxicity.

(7) Fomesafen tested negative in assay

systems for gene mutation, structural

chromosome aberration, and other

genotoxic effects. Fomesafen did

produce a weak clastogenic response in

rat bone marrow.

(8) Metabolism studies in rats indicate

that more than 90 percent of the

compound is excreted within 7 days of

ingestion. The rat metabolism studies

also show that fomesafen tends to

concentrate in the liver, prior to

excretion. Fomesafen is metabolized

through hydrolytic cleavage of the

amide linkage to form aciflurofen,

which is classified by EPA as a probable

human carcinogen (Group B2).

Based on a weight-of evidence

determination, OPP’s Health Effects

Division, Carcinogenicity Peer Review

Committee (CPRC) has classified

fomesafen as a Group C carcinogen

(possible human carcinogen). The

upper-bound carcinogenic risk from

dietary exposure to fomesafen was

calculated using a potency factor (Q*) of

0.19 (mg/kg/day)-1 and dietary exposure

as estimated by the Anticipated Residue

Contribution (ARC) for existing

tolerances and the proposed tolerance

for snap beans. The upper-bound

carcinogenic risk from established

tolerances and the proposed tolerance

for snap beans is calculated at 1.56 ×

10-6. The upper-bound cancinogenic risk

from the proposed use on snap beans is

calculated at 1.4 × 10-6. EPA concludes

that the potential cancer risk from

residues of fomesafen resulting from

established tolerances and the proposed

tolerance for snap beans is negligible.

The Reference Dose (RfD) for

fomesafen has not been established by

OPP’s Health Effects Division, RfD

Committee. For purposes of this action,

the RfD is calculated at 0.0025 mg/kg of

body weight/day. The RfD is based on

a NOEL of 0.25 mg/kg/day from the rat

feeding/carcinogenicity study and an

uncertainty factor of 100. The ARC for

the overall U.S. population from

established tolerances and the proposed

tolerance for snap beans utilizes less

than 1 percent of the RfD. EPA generally

has no concern for exposures below 100

percent of the RfD.

The nature of the residue in plants

and animals is adequately understood.

The residue of concern is fomesafen per

se. An adequate analytical method for

enforcing this tolerance has been

published in the Pesticide Analytical

Manual (PAM 11). Secondary residues

are not expected to occur in milk, eggs,

and meat as a result of this action since

snap beans are not a significant

livestock feed commodity.

There are presently no actions

pending against the continued
Federal Register / Vol. 61, No. 119 / Wednesday, June 19, 1996 / Proposed Rules 31077

registration of this chemical. The

pesticide is considered useful for the

purpose for which the tolerance is

sought.

Based on the information and data

considered, the Agency has determined

that 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 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 notice 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 docket

number [PP 6E4653/P665].

A record has been established for this

rulemaking under docket number [PP

6E4653/P665], (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, 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.

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 Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

Under Executive Order 12866 (58 FR

51735, October 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 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.

This action does not impose any

enforceable duty, or contain any

‘‘unfunded mandates’’ as described in

Title II of the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104–4), or

require prior consultation as specified

by Executive Order 12875 (58 FR 58093,

October 28, 1993), entitled Enhancing

the Intergovernmental Partnership, or

special consideration as required by

Executive Order 12898 (59 FR 7629,

February 16, 1994).

Pursuant to the requirements of the

Regulatory Flexibility Act (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 explaining the

factual basis for this determination 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: June 7, 1996.

Susan Lewis,

Acting 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 § 180.433, by designating the

existing text as paragraph (a) and by

adding a paragraph (b) to read as

follows:

§ 180.433 Sodium salt of fomesafen;

tolerances for residues.

(a) * * *

(b) Tolerances with regional

registration are established for residues

of the sodium salt of fomesafen, 5-[2-

chloro-4-(trifluoromethyl)phenoxy]-4-N-

(methylsulfonyl)-2-nitrobenzamide, in

or on the raw agricultural commodities,

as follows:

Commodities Parts per

million

Expiration date

Beans, snap .......... 0.05 December 31,

1998

[FR Doc. 96–15480 Filed 6–18–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 1E4031/P666; FRL–5369–4]

RIN 2070–AB78

3-Dichloroacetyl-5-(2-furanyl)-2,2-

dimethyloxazolidine; Extension of

Temporary Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to extend the

time-limited tolerances for residues of

the inert ingredient (safener), 3-

dichloroacetyl-5-(2-furanyl)-2,2-

dimethyloxazolidine (CAS Reg. No.

121776–33–8) in or on corn from June

30, 1996 to June 30, 1998.

DATES: Comments, identified with the

docket number [PP 1E4031/P666] must

be received on or before July 5, 1996.

ADDRESSES: By mail, submit written

comments to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental