Federal Register / Vol. 60, No. 50 / Wednesday, March 15, 1995 / Proposed Rules 13941

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 4E4359/P604]. 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

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: February 28, 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 § 180.205, paragraph (a) is

amended in the table therein by adding

and alphabetically inserting the raw

agricultural commodities lentils, lentil

forage, and lentil hay, to read as follows:

§ 180.205 Paraquat; tolerances for

residues.

(a) * * *

Commodity Parts per

million

* * * * *

Lentils ........................................ 0.3

Lentil, forage ............................. 0.1

Lentil, hay ................................. 0.4

* * * * *

* * * * *

[FR Doc. 95–6418 Filed 3–14–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 0E3909, 2E4052, 2E4065, 2E4092, and

3E4162/P602; FRL–4936–1]

RIN 2070–AC18

Pesticide Tolerances for 2-[1-

(Ethoxyimino)Butyl]-5-[2-

(Ethylthio)Propyl]-3-Hydroxy-2-

Cyclohexen-1-One

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish

time limited tolerances for the

combined residues of the herbicide 2-[1-

(ethoxyimino)butyl]-5-[2-

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

cyclohexen-1-one (also referred to in

this document as sethoxydim) and its

metabolites in or on various raw

agricultural commodities. The

Interregional Research Project No. 4 (IR4) requested the proposed regulation to

establish maximum permissible levels

for residues of the herbicide. These

time-limited tolerances would expire on

December 31, 1996.

DATES: Comments, identified by the

document control number [PP 0E3909,

2E4052, 2E4065, 2E4092, and 3E4162/

P602], must be received on or before

April 14, 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: 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 Hwy., Arlington,

VA 22202, (703)-308-8783.

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 petitions (PP)

0E3909, 2E4052, 2E4065, 2E4092, and

3E4162 to EPA on behalf of the named

Agricultural Experiment Stations.

These petitions request 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 180.412 by

establishing time-limited tolerances for

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 certain raw agricultural

commodities as follows:

1. PP 0E3909. Petition submitted on

behalf of the Experimental Stations of

Massachusetts, Washington, and
13942 Federal Register / Vol. 60, No. 50 / Wednesday, March 15, 1995 / Proposed Rules

Wisconsin proposing a tolerance for

cranberry at 2.0 parts per million (ppm).

2. PP 2E4052. Petition submitted on

behalf of the Experimental Stations of

South Dakota and Washington

proposing tolerances for peppermint

and spearmint at 30 ppm.

3. PP 2E4065. Petition submitted on

behalf of the Experimental Station of

Florida proposing a tolerance for endive

at 2.0 ppm. The petitioner proposed that

use of sethoxydim on 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.

4. PP 2E4092. Petition submitted on

behalf of the Experimental Stations of

California, Florida, Maryland, Michigan,

New Jersey, North Carolina, and

Tennessee proposing a tolerance for

carrot at 1.0 ppm.

5. PP 3E4162. Petition submitted on

behalf of the Experimental Stations of

Arkansas, Arizona, Michigan, North

Carolina, Oklahoma, and Washington

proposing a tolerance for asparagus at

4.0 ppm.

The scientific data submitted in the

petitions and other relevant material

have been evaluated. The toxicological

data considered in support of the

proposed tolerances include:

1. Several acute toxicology studies

place technical sethoxydim in acute

toxicity category IV for primary eye and

dermal irritation and acute toxicity

category III for acute oral, dermal, and

inhalation. The dermal sensitization -

guinea pig study was waived because no

sensitization was seen in guinea pigs

dosed with the end-use product Poast

(18 percent a.i.).

2. A 1-year feeding study with dogs

fed diets containing 0, 8.86/9.41, 17.5/

19.9, and 110/129 milligrams (mg)/

kilogram (kg)/day (males/females) with

a no-observed-effect-level (NOEL) of

8.86/9.41 mg/kg/day (males/females)

based on equivocal anemia in male dogs

at the 17.5-mg/kg/day dose level.

3. A 2-year chronic feeding/

carcinogenicity study with mice fed

diets containing 0, 40, 120, 360, and

1,080 ppm (equivalent to 0, 6, 18, 54,

and 162 mg/kg/day) with a systemic

NOEL of 120 ppm (18 mg/kg/day) based

on non-neoplastic liver lesions in male

mice at the 360-ppm (54 mg/kg/day)

dose level. There were no carcinogenic

effects observed under the conditions of

the study. The maximum tolerated dose

(MTD) was not achieved in female mice.

4. A 2-year chronic feeding/

carcinogenic study with rats fed diets

containing 0, 2, 6, and 18 mg/kg/day

with a systemic NOEL greater than or

equal to 18 mg/kg/day (highest dose

tested). There were no carcinogenic

effects observed under the conditions of

the study. This study was reviewed

under current guidelines and was found

to be unacceptable because the doses

used were insufficient to induce a toxic

response and an MTD was not achieved.

5. A second chronic feeding/

carcinogenic study with rats fed diets

containing 0, 360, and 1,080 ppm

(equivalent to 18.2/23.0, and 55.9/71.8

mg/kg/day (males/females). The dose

levels were too low to elicit a toxic

response in the test animals and failed

to achieve an MTD or define a lowest

effect level (LEL). Slight decreases in

body weight in rats at the 1,080-ppm

dose level, although not biologically

significant, support a free-standing noobserved-adverse-effect-level (NOAEL)

of 1,080 ppm (55.9/71.8 mg/kg/day

(males/females)). There were no

carcinogenic effects observed under the

conditions of the study.

6. A developmental toxicity study in

rats fed dosages of 0, 50, 180, 650, and

1,000 mg/kg/day with a maternal

NOAEL of 180 mg/kg/day and a

maternal LEL of 650 mg/kg/day

(irregular gait, decreased activity,

excessive salivation, and anogenital

staining); and a developmental NOAEL

of 180 mg/kg/day, and a developmental

LEL of 650 mg/kg/day (21 to 22 percent

decrease in fetal weights, filamentous

tail, and lack of tail due to the absence

of sacral and/or caudal vertebrae, and

delayed ossification in the hyoids,

vertebral centrum and/or transverse

processes, sternebrae and/or

metatarsals, and pubes).

7. A developmental toxicity study in

rabbits fed doses of 0, 80, 160, 320, and

400 mg/kg/day with a maternal NOEL of

320 mg/kg/day and a maternal LOEL of

400 mg/kg/day (37% reduction in body

weight gain without significant

differences in group mean body weights

and decreased food consumption during

dosing); and a developmental NOEL

greater than 400 mg/kg/day (highest

dose tested).

8. A two-generation reproduction

study with rats fed diets containing 0,

150, 600, and 3,000 ppm (approximately

0, 7.5, 30, and 150 mg/kg/day) with no

reproductive effects observed under the

conditions of the study.

Although the dose levels were

insufficient to elicit a toxic response,

the Agency considers this study usable

for regulatory purposes and has

established a free-standing NOEL of

3,000 ppm (approximately 150 mg/kg/

day).

9. Mutagenicity studies including:

Ames assays were negative for gene

mutation in Salmonella typhimurium

strains TA98, TA100, TA1535, and TA

1537, with and without metabolic

activity; a Chinese hamster bone

marrow cytogenetic assay was negative

for structural chromosomal aberrations

at doses up to 5,000 mg/kg in Chinese

hamster bone marrow cells in vivo; and

recombinant assays and forward

mutations tests in Bacillus subtilis,

Escherichia coli, and S. typhimurium

were all negative for genotoxic effects at

concentrations of greater than or equal

to 100 percent.

10. In a rat metabolism study,

excretion was extremely rapid and

tissue accumulation was negligible.

The reference dose (RFD) is calculated

at 0.09 mg/kg of body weight/day, based

on a NOEL of 8.86 mg/kg/day from the

1-year feeding study in dogs and an

uncertainty factor of 100. The

theoretical maximum residue

contribution (TMRC) from existing

tolerances for the overall U.S.

population is estimated at 0.031961 mg/

kg of body weight/day, or 36% of the

RfD. The proposed tolerances for

asparagus, carrot, cranberry, endive,

peppermint, and spearmint will

increase the TMRC by 0.000701 mg/kg

of body weight/day and will utilize less

than 1 percent of the RfD for the overall

U.S. population. EPA estimates indicate

that dietary exposure will not exceed

the RfD for any population subgroup for

which EPA has data.

These tolerances are proposed as

time-limited tolerances since an

acceptable carcinogenicity study is

needed in one rodent species. A repeat

chronic feeding/carcinogenicity study in

rats is underway and is due to be

submitted to EPA in November of 1995.

The Agency will reassess sethoxydim

tolerances based on the outcome of the

rat chronic feeding/carcinogenicity

study and, if appropriate, will establish

permanent tolerances for asparagus,

carrot, cranberry, endive, peppermint

and spearmint. In the interim, the

Agency concludes that there is little risk

from establishment of the proposed

tolerances since available studies in rats

and mice indicate no carcinogenic

effects, there are adequate data to

establish a RfD, existing tolerances and

the proposed tolerances do not exceed

the RfD, and the proposed tolerances

utilize less than 1 percent of the RfD.

The nature of the residue is

adequately understood, and adequate

analytical methods are available for

enforcement purposes. Enforcement

methods for sethoxydim are listed in the

Pesticide Analytical Manual, Vol. II

(PAM II). Enforcement methods have
Federal Register / Vol. 60, No. 50 / Wednesday, March 15, 1995 / Proposed Rules 13943

also been submitted to the Food and

Drug Administration for publication in

PAM II. Because of the long lead time

for publication of the analytical

methods in PAM II, the analytical

methods are 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.

There is no reasonable expectation

that secondary residues will occur in

milk, eggs or meat of livestock and

poultry from the proposed uses of

sethoxydim on asparagus, cranberries,

endive, and mint; there are no livestock

feed items associated with these

commodities. Any secondary residues

occurring in meat, fat, meat byproducts

and milk of cattle, goats, hogs, horses

and sheep from the proposed use on

carrots will be covered by existing

tolerances. There are no residues

expected to occur in poultry meat, meat

byproducts, fat or eggs since carrots are

not considered a poultry feed item.

Based on the information and data

considered, the Agency has determined

that the tolerances established by

amending 40 CFR part 180 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 0E3909, 2E4052,

2E4065, 2E4092, and 3E4162/P602]. 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 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.

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: February 28, 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 § 180.412, by revising the section

heading and the introductory text of

paragraphs (a) and (b) to correct the

spelling of the chemical name and by

adding new paragraphs (c) and (d), to

read as follows:

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

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

(a) 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 raw agricultural

commodities:

* * * * *

(b) Tolerances with regional

registration, as defined in § 180.1(n), 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 raw agricultural

commodities:

* * * * *

(c) Time-limited tolerances to expire

December 31, 1996, are established for

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 raw agricultural

commodities:

Commodity Parts per

million

Asparagus ................................. 4.0

Carrot ........................................ 1.0

Cranberry .................................. 2.0

Peppermint ................................ 30.0

Spearmint .................................. 30.0

(d) Time-limited tolerances to expire

December 31, 1996, are established with

regional registration, as defined in

§ 180.1(n), for 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 raw agricultural

commodities:

Commodity Parts per

million

Endive ....................................... 2.0

[FR Doc. 95–6419 Filed 3–14–95; 8:45 am]

BILLING CODE 6560–50–F