Federal Register / Vol. 60, No. 50 / Wednesday, March 15, 1995 / Proposed Rules 13939

44931, August 31, 1994), EPA has

determined that when used in

accordance with good agricultural

practice, this ingredient is useful and

that the tolerances will protect the

public health. Therefore, EPA is

proposing to establish permanent

tolerances 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 8F3658/P605]. 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 exemptions

from tolerance requirements do not have

a significant 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).

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 15, 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. By revising § 180.459, to read as

follows:

§ 180.459 Triasulfuron; tolerances for

residues.

Tolerances are established for

residues of the herbicide triasulfuron,

[3-(6-methoxy-4-methyl-1,3,5-triazin-2-

yl)-1-(2-(2-

chloroethoxy)phenylsulfonyl)urea] in or

on the following raw agricultural

commodities:

Commodity Parts per

million

Barley, forage ........................... 5.0

Barley, grain .............................. 0.02

Barley, straw ............................. 2.0

Cattle, fat .................................. 0.1

Cattle, kidney ............................ 0.2

Cattle, mbyp (except kidney) .... 0.1

Cattle, meat .............................. 0.1

Goats, fat .................................. 0.1

Goats, kidney ............................ 0.2

Goats, mbyp (except kidney) .... 0.1

Goats, meat .............................. 0.1

Hogs, fat ................................... 0.1

Hogs, kidney ............................. 0.2

Hogs, mbyp (except kidney) ..... 0.1

Hogs, meat ............................... 0.1

Horses, fat ................................ 0.1

Horses, kidney .......................... 0.2

Horses, mbyp (except kidney) .. 0.1

Horses, meat ............................ 0.1

Milk ............................................ 0.02

Sheep, fat8 ............................... 0.1

Sheep, kidney ........................... 0.2

Sheep, mbyp (except kidney) ... 0.1

Sheep, meat ............................. 0.1

Wheat, forage ........................... 5.0

Wheat, grain ............................. 0.02

Wheat, straw ............................. 2.0

[FR Doc. 95–6417 Filed 3–14–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 4E4359/P604; FRL–4936–3]

RIN 2070–AC18

Pesticide Tolerance for Paraquat

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish

tolerances for residues of the desiccant,

defoliant, and herbicide paraquat in or

on the raw agricultural commodities

lentils, lentil forage, and lentil hay. The

proposed regulation to establish

maximum permissible levels for

residues of the herbicide was requested

in a petition submitted by the

Interregional Research Project No. 4 (IR4).

DATES: Comments, identified by the

document control number, [PP 4E4359/

P604], 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 petition (PP)

4E4359 to EPA on behalf of the

Agricultural Experiment Stations of

Idaho and Washington. 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

180.205 by establishing tolerances for

residues of paraquat (1,1’-dimethyl-4,4’-
13940 Federal Register / Vol. 60, No. 50 / Wednesday, March 15, 1995 / Proposed Rules

bipyridinium-ion) derived from

application of either the bis (methyl

sulfate) or the dichloride salt (both

calculated as the cation), in or on the

raw agricultural commodities lentils at

0.3 part per million (ppm), lentil forage

at 0.1 ppm, and lentil hay at 0.4 ppm.

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. A 1-year feeding study in dogs fed

diets containing 0, 15, 30, and 50 ppm

(equivalent to 0, 0.45, 0.93, and 1.51

milligrams/kilogram (mg/kg) of body

weight (bwt) day with a no-observedeffect level (NOEL) of 15 ppm (0.45 mg/

kg/day) based on increased severity and

extent of chronic pneumonitis in both

sexes, especially males, at the 30-ppm

dose level.

2. A 23-month chronic feeding/

carcinogenicity study in mice fed diets

containing 12.5, 37.5, and 100/125 ppm

paraquat ion (the highest dose tested

(HDT) was increased from 100 to 125

ppm at week 36) with a systemic NOEL

of 12.5 ppm (equivalent to 1.87 mg/kg/

day) based on renal tubular

degeneration in male mice, and weight

loss and decreased food intake in female

mice. There were no carcinogenic

effects observed under the conditions of

the study.

3. A 2-year chronic feeding/

carcinogenicity study in Fischer rats fed

diets containing 0, 1.25, 3.75, and 7.5

mg/kg/day with equivocal (uncertain)

evidence of carcinogenicity (squamous

cell carcinomas) in the head region (ear,

nasal cavity, oral cavity, and skin) of

male rats of the highest dose level

group, and an approximate systemic

NOEL of 1.25 mg/kg/day based on

incidence of opacities, cataracts, and

nonneoplastic lung lesions (alveolar

macrophages and epithelialization and

slight peribronchiolar lymphoid

hyperplasia). The squamous cell

carcinomas were not associated with

oral exposure, but were the result of

topical exposure (through powdered

diet).

4. A 2-year chronic feeding/

carcinogenicity study in Wistar rats fed

diets containing 6, 30, 100, and 300

ppm (paraquat dichloride) with a

systemic NOEL of 100 ppm (equivalent

to 5 mg/kg/day) based on increased

mortality in males and females;

decreased erythrocytes, hemoglobin,

and serum protein in males and females;

decreased hematocrit, glucose and

corpuscular cholinesterase activity in

males; decreased leukocytes, albuminto-globulin ratio, and alkaline

phosphatase; increased

polymorphonucleocytes in males;

increased potassium and glucose in

females; decreased absolute and/or

relative weights of heart (males and

females), liver and brain (females); and

increased absolute weights of kidneys

(males and females) at the highest dose

tested (HDT) (equivalent to 15 mg/kg/

day). There was no evidence of

carcinogenicity observed under the

conditions of the study.

5. A developmental toxicity study in

rats given gavage dosages of 1, 5, and 10

mg paraquat ion/kg of body weight from

day 6 through day 15 of pregnancy with

NOEL’s for fetotoxic effects and

maternal toxicity of 1.0 mg/kg/day. The

lowest effect level (LEL) was established

at 5 mg/kg/day based on weight

reduction and slight retardation in

ossification (fetotoxicty) and

piloerection, weight loss, and hunched

appearance (maternal toxicity).

6. A developmental toxicity study in

mice given gavage dosages of 1, 5, and

10 mg/kg/day with no developmental

toxicity observed under the conditions

of the study at any dosage level tested.

7. A three-generation reproduction

study with rats fed diets containing 25,

75, and 150 ppm with a systemic NOEL

of 25 ppm (equivalent to 1.25 mg/kg/

day) based on an increased incidence of

alveolar histiocytosis in the lungs of

male and female parents. There were no

reproductive effects observed under the

conditions of the study.

8. Paraquat was negative in 10

mutagenicity studies (mostly gene

mutation and chromosome aberration

studies and one DNA damage/repair

assay); weakly positive in four studies

(two gene mutation, one chromosome

aberration, and one DNA damage/repair

assay); and positive in four studies (all

DNA damage/repair assays).

The Agency (Peer Review Committee)

initially classified paraquat as a category

‘‘C’’ carcinogen based on the significant

increase of squamous cell carcinomas in

the head region of the high-dose males

in the Fisher rat chronic feeding/

carcinogenicity study. Review of the

study by an independent laboratory

concluded that those tumor sites should

not be combined; without the

combination, there were no statistically

significant tumor increases for any

particular tumor type. Discussion and

review by the Agency (Peer Review

Committee) concluded that these tumor

sites normally should not be combined

when the exposure to the chemical is by

the oral route and that these tumors are

likely the result of topical exposure to

paraquat contained in the powdered

diet (paraquat is a topical irritant), not

the result of exposure through the

gastrointestinal tract. The Agency

considered two additional studies (rat

and mouse carcinogenicity studies) and

further evaluated the tumors in the male

rats. Based on all the information, the

Agency concluded that there is no

evidence of carcinogenicity in male

Wistar rats at 12 mg/kg/day (HDT) and

female Wistar rats at 15 mg/kg/day. The

Agency concluded that there was at best

equivocal evidence of carcinogenicity in

male Fisher rats at 7.5 mg/kg/day and

that this equivocal evidence was

associated with irritation due to topical

exposure, and not with oral exposure.

Paraquat was, therefore, placed in

Category E (not a human carcinogen).

Because paraquat is a restricted-use

pesticide and precautionary measures

are required to protect applicators from

the acute toxicity of the chemical, the

potential for carcinogenic effects by

excessive (irritating) topical exposure is

not a concern for applicators.

The reference dose (RfD) is

established at 0.0045 mg/kg body

weight/day based on a NOEL of 0.45

mg/kg/day from the 1-year dog study

and an uncertainity factor of 100. The

theoretical maximum residue

contribution (TMRC) from existing uses

of paraquat utilizes 42% of the RfD for

the general U.S. population, or 95.7% of

the RfD for children, aged 1 to 6 years

old (the population subgroup most

highly exposed). The proposed

tolerance for lentils would utilize

0.008% of the RfD for the U.S.

population, or 0.007% of the RfD for

children, aged 1 to 6 years.

The nature of the residue is

adequately understood for the purpose

of these tolerances. An adequate

analytical method is available for

enforcement purposes. The analytical

method for enforcing these tolerances

has been published in the Pesticide

Analytical Manual, Vol. II (PAM II). Any

secondary residues in milk, eggs, or

meat of livestock and poultry will fall

within existing tolerances for these

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 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
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