18560 Federal Register / Vol. 60, No. 70 / Wednesday, April 12, 1995 / Proposed Rules

document published in the Federal

Register of December 31, 1987 (54 FR

49484) for details.

The reference dose (RFD) based on a

NOEL of 1.0 mg/kg/day (1-year feeding

study in dogs) and an uncertainty factor

of 100 was calculated to be 0.01 mg/kg/

day. The theoretical maximum residue

contribution (TMRC) for the overall U.

S. population from published and

proposed uses recommended through

reregistration is 0.000532 mg/kg/day or

5.3% of the RfD. For the most highly

exposed subgroup, nonnursing infants

less than 1 year old, the published and

proposed use recommended through

reregistration is 0.002184 mg/kg/day or

21.8% of the RfD. The current action of

increasing the tolerance on sorghum

forage to 2.0 does not contribute any

additional TMRC or utilize additional

RfD because sorghum forage is not a

human food and current tolerances in

livestock commodities will not be

exceeded as a result of the proposed

increase in the tolerance for sorghum

forage.

Refinements in residue and percentcrop treated information were

considered in calculating the

Anticipated Residue Contribution (ARC)

for the same population groups above.

The ARC is considered the more

accurate estimate of dietary exposure.

These exposure estimates were then

compared to the RfD for alachlor to get

estimates of chronic dietary risk. The

ARC for the overall U. S. population for

published tolerances is 1.3 X 10-5 or

0.1% of the RfD. For the most highly

exposed subgroup, nonnursing infants,

the ARC is 5.4 X 10-5 or less than 1%

of the RfD. The current action does not

contribute additional ARC or utilize

additional RfD. Other tolerances

proposed by reregistration result in an

ARC of 4.0 X 10-6 mg/kg/day or 0.04%

of the RfD for the overall U.S.

population and an ARC of 5.3 X 10-5

mg/kg/day or 0.5% of the RfD for

nonnursing infants, less than 1 year old.

Based on a Q*1 of 0.08 (mg/kg/day)-1

the upper-bound cancer risk was

calculated to be 1.4 X 10-6 and

contributed through all published and

proposed uses for alachlor. The current

action for sorghum forage contributes no

additional risks.

There are currently no regulations

against the registration of this chemical

for use on sorghum forage. Even though

alachlor is classified as a probable

human carcinogen, EPA believes the

establishment of this tolerance will not

pose an unreasonable risk to humans as

a result of dietary exposure.

The pesticide is useful for the

purposes for which tolerances are

sought. The nature of the residues is

adequately understood for the purposes

of establishing tolerances. Adequate

analytical methods (high-pressure liquid

chromatography and gas

chromatography) are available for

enforcement purposes (PAM II, Method

III).

Based on the information considered

by the Agency, the Agency has

determined that when used in

accordance with good agricultural

practice, this ingredient is useful and

that the tolerance established by

amending 40 CFR part 180 would

protect the public health. It is proposed,

therefore, 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 document in the

Federal Register that this rulemaking

proposal be referred to an Advisory

Committee in accordance with section

408(e) of the Federal Food, Drug and

Cosmetic Act.

Interested persons are invited to

submit written comments on the

proposed regulation. Comments must

bear a notation indicating the document

control number, [PP 8F3671/P610]. 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.

The Office of Management and Budget

has exempted this rule from the

requirements of section 3 of Executive

Order 12866. 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 30, 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 § 180.249, by amending the table

therein by revising the entry for

sorghum forage, to read as follows:

§ 180.249 Alachlor; tolerances for

residues.

* * * * *

Commodity Parts per

million

* * * * *

Sorghum, forage ....................... 2.0

* * * * *

[FR Doc. 95–8729 Filed 4–11–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Parts 180 and 186

[PP 8F3646 and FAP 8H5558/P611; FRL–

4947–3]

RIN 2070–AC18

Sethoxydim; Pesticide Tolerance and

Feed Additive Regulation

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to increase the

established pesticide tolerance for the

combined residues of the herbicide

sethoxydim (2-[1-(ethoxyimino)butyl]-5-

[2-(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one) and its metabolites

containing the 2-cyclohexen-1-one

moiety (calculated as the herbicide) in

or on the raw agricultural commodity

sugar beet roots to 1.0 part per million

(ppm) and to increase the established

feed additive regulation on the animal

feed commodity sugarbeet molasses to

10.0 ppm. The BASF Corp. requested

these regulations to establish the

maximum permissible levels for

residues of the pesticide in or on the

above commodities.

DATES: Comments, identified by the

document control number, [PP 8F3646

and FAP 8H5558/P611], must appear on

or before May 12, 1995.

ADDRESSES: By mail, submit written

comments to: Public Response and
Federal Register / Vol. 60, No. 70 / Wednesday, April 12, 1995 / Proposed Rules 18561

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, Robert J. Taylor, Product Manager

(PM-25), Registration Division (7505C),

Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm 241, CM #2, 1921 Jefferson Davis

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

6027; e-mail:

taylor.robert@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued notices, published in the Federal

Register of October 12, 1988 (53 FR

39783 and 39785), which announced

that BASF Corp., P.O. Box 13528,

Research Triangle Park, NC 27709-3528,

had submitted pesticide petition (PP)

8F3646 and a feed additive petition

(FAP) 8H5558 to EPA. Pesticide petition

8F3646 requests that the Administrator,

pursuant to section 408(d) of the Federal

Food, Drug and Cosmetic Act (FFDCA),

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

180 by establishing a tolerance for the

combined residues of the herbicide

sethoxydim (2-[1-ethoxyimino)butyl]-5-

[2-(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one) and its metabolites

containing the 2-cyclohexen-1-one

moiety (calculated as the herbicide)) in

or on the raw agricultural commodity

(RAC) sugarbeet roots at 1.0 part per

million (ppm). Feed additive petition

8H5558 requests that the Administrator,

pursuant to section 409(e) of FFDCA (21

U.S.C. 348), amend 40 CFR part 186 by

establishing a feed additive regulation

for the combined residues of the

herbicide sethoxydim and its

metabolites containing the 2-

cyclohexen-1-one moiety (calculated as

the herbicide) in or on the animal feed

sugar beet molasses at 5.0 ppm.

There were no comments or requests

for referral to an advisory committed

received in response to these notices.

The petitioner subsequently amended

the notice for FAP 8H5558 by

submitting a revised Section F

proposing to increase the established

feed additive regulation to permit

residues of sethoxydim in the animal

feed sugar beet molasses at 10.0 ppm.

Because the 10.0 ppm has not been

proposed previously and because it has

been longer than 5 years since the

original proposal, the tolerances of 1.0

ppm on sugar beet roots and 10.0 ppm

on sugar beet molasses are being

proposed for 30 days to allow for public

comment.

The information submitted in the

petitions and other relevant material

have been evaluated. The pesticide is

useful for the purpose for which the

tolerances are sought. The toxicological

data and other information considered

in support of PP 8F3646 and FAP

8H5558 are discussed in the final rule

referring to pesticide petitions (PP)

9F3855, 2F4121, and 4F4413, which

appears elsewhere in the ‘‘Rules and

Regulations’’ section of this issue of the

Fedral Register.

The reference dose (RfD) based on a

NOEL of 8.86 mg/kg/day in the 1-year

feeding study in dogs and an

uncertainty factor of 100 was calculated

to be 0.09 mg/kg bwt/ day. The

theoretical maximum residue

contribution (TMRC) for existing

tolerances for the overall U.S.

population is 0.032904 mg/kg bwt/day

or 36.5% of the RfD. The current action

will increase the TMRC by 0.000299

mg/kg bwt/day. These tolerances and

previously established tolerances utilize

36.8% of the RfD for the overall U.S.

population. For U.S. subgroup

populations, nonnursing infants and

children aged 1 to 6, the current action

and previously established tolerances

utilize, respectively, a total of 63.136

and 74.318% of the RfD, assuming that

residue levels are at the established

tolerances and that 100% of the crop is

treated.

Based on the information and the data

considered, the Agency has determined

that the tolerances established by

amending 40 CFR part 180 would

protect the public health, and the

establishment of a feed additive

regulation by amending 40 CFR part 186

would be safe. Therefore, it is proposed

that they 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, 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 as it

relates to the section 408 tolerance 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 8F3646 and FAP

8H5558/P611]. All written comments

filed in response to these petitions 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 of 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.

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, or establishing or raising

food/feed additive regulations 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).
18562 Federal Register / Vol. 60, No. 70 / Wednesday, April 12, 1995 / Proposed Rules

List of Subjects in 40 CFR Parts 180 and

186

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Feed

additives, Pesticides and pests,

Reporting and recordkeeping

requirements.

Dated: March 30, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, it is proposed that chapter

I of title 40 of the Code of Federal

Regulations be amended as follows:

PART 180—[AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follow:

Authority: 21 U.S.C. 346a and 371.

b. In § 180.412(a), by amending the

table therein by revising the entry for

sugar beet, roots, to read as follows:

§ 180.412 2-[1-(Ethoxyimino)butyl]-5-[2-

(ethylthio)propyl]-3-hydroxy-2-cyclohexen1-one; tolerances for residues.

(a) * * *

Commodity Part per

million

* * * * *

Sugar beet, roots ...................... 1.0

* * * * *

* * * * *

PART 186—[AMENDED]

2. In part 186:

a. The authority citation for part 186

continues to read follows:

Authority: 21 U.S.C. 348.

b. In § 186.2800, by revising the

section heading and introductory text

and by amending the table therein by

revising the entry for sugar beet

molasses, to read as follows:

§ 186.2800 2-[1-(Ethoxyimino)butyl]-5-[2-

(ethylthio)propyl]-3-hydroxy-2-cyclohexen1-one.

Tolerances are established for the

combined residues of the herbicide 2-[1-

(ethoxyimino)butyl]-5-[2-

(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one and its metabolites

containing the 2-cyclohexen-1-one

moiety (calculated as the herbicide) in

or on the following commodities:

Food Part per

million

* * * * *

Sugar beet molasses ................ 10.0

* * * * *

[FR Doc. 95–8732 Filed 4–11–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Parts 180, 185, and 186

[PP 9F3731 and FAP 9H5574/P612; FRL–

4948–4]

RIN 2070–AC18

Cyfluthrin; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish

time-limited tolerances, with an

expiration date of November 15, 1997,

for residues of the synthetic pyrethroid

cyfluthrin in or on the raw agricultural

commodities (RAC’s) tomatoes; carrots;

peppers; radishes; meat, fat, and meat

byproducts of cattle, goats, horses, hogs,

poultry, and sheep; milkfat; and eggs

and in food/feed additive commodities

tomato, pomace (dry and wet) and

tomato concentrated products. Miles

Corp., Animal Products (formerly

Mobay Corp.), requested the proposed

tolerances and regulations to establish

maximum permissible levels for

residues of the pesticide.

DATES: Comments, identified by the

document control number, [PP 9F3731

and FAP 9H5574/P612], must be

received on or before May 12, 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 notice 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: George T. LaRocca, Product

Manager (PM) 13, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 200, CM #2, 1921 Jefferson Davis

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

6100.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the

Federal Register of March 23, 1989 (54

FR 35434), which announced that Miles

Corp. had submitted pesticide petition

(PP) 9F3731 and food/feed additive

petition (FAP) 9H5574 to EPA.

Pesticide petition (PP) 9F3731

requests that the Administrator,

pursuant to section 408(d) of the Federal

Food, Drug, and Cosmetic Act (FFDCA),

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

180.436 by increasing tolerances for

residues of the insecticide cyfluthrin,

cyano(4-fluoro-3-phenoxyphenyl)-

methyl-3-(2,2-dicloroethenyl)-2,2-

dimethylcyclopropanecarboxylate, in or

on the raw agricultural commodities

alfalfa forage at 5.0 ppm; alfalfa hay at

10.0 ppm; broccoli at 2.0 ppm; brussels

sprouts at 0.5 ppm; cabbage at 1.0 ppm;

cauliflower at 0.5 ppm; carrots at 0.1

ppm; celery at 1.5 ppm; lettuce at 2.5

ppm; peppers at 0.2 ppm; radishes at 0.5

ppm; spinach at 1.0 ppm; sweet corn at

0.05 ppm; sweet corn forage at 1.0 ppm;

sunflower seed at 0.02 ppm; sunflower

forage at 1.0 ppm; soybeans at 0.03 ppm;

soybean forage at 10.0 ppm; soybean

hay at 1.5 ppm; soybean straw at 1.0

ppm; tomato at 0.2 ppm; milk at 0.1

ppm; eggs at 0.01 ppm; meat, fat and

meat byproduct of cattle, goats, hogs,

horses, and sheep at 1.5 ppm; and meat,

fat, and meat byproducts of poultry at

0.01 ppm.

Food/feed additive petition (FAP)

9H5574 requests that the Administrator,

pursuant to section 409(e) of the FFDCA

(21 U.S.C. 348(e)) amend 40 CFR parts

185 and 186 by establishing a food/feed

additive regulation for cyfluthrin in or

on processed food commodities tomato

concentrated products at 0.5 ppm and

feed commodities sweet corn (cannery

wastes) at 1.5 ppm; tomato, pomace

(wet) at 1.5 ppm; tomato, pomace dry at

5.0 ppm.; soybean hulls at 0.1 ppm; and

sunflower hulls at 2.5 ppm.

On July 20, 1993, Miles Corp.

requested that the pesticide petition and

food/feed additive petition be amended

by withdrawing the proposed tolerance