18558 Federal Register / Vol. 60, No. 70 / Wednesday, April 12, 1995 / Proposed Rules

1. Available data demonstrate that

oleyl alcohol is no more than slightly

toxic to mammals, fish, and aquatic

invertebrates.

2. Oleyl alcohol is found in fish oils

and one of its uses is as a carrier for

medicaments. Anticipated residues of

oleyl alcohol at the proposed level of

use are expected to be of little or no

toxicological significance.

3. Oleyl alcohol is approved by the

Food and Drug Administration for use

as a component of paper and

paperboard under 21 CFR 176.170, as

defoaming agent under 21 CFR 176.210,

and as a component of animal glue

under 21 CFR 178.3120.

Based upon the above information

and review of its use, the Agency does

not believe that a potential for

significant hazard exists when used in

accordance with good agricultural

practice. The Agency believes and that

this ingredient is useful and a tolerance

is not necessary to protect the public

health. Therefore, EPA proposes that the

exemption from the requirement of a

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, [OPP-300384]. 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 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 29, 1995.

James J. Jones,

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. Section 180.1001(c) is amended in

the table therein by adding and

alphabetically inserting the inert

ingredient, to read as follows:

§ 180.1001 Exemptions from the

requirements of a tolerance.

* * * * *

(c) * * *

Inert ingredients Limits Uses

* * * * * * *

Oleyl alcohol (CAS Reg. No 143-28-2) ......................... 15% ........................................... Cosolvent

* * * * * * *

* * * * *

[FR Doc. 95–8730 Filed 4–11–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 8F3671/P610; FRL–4945–3]

RIN 2070–AC18

Alachlor; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This document proposes to

establish an increased tolerance for

residues of the herbicide alachlor (2-

chloro-2’,6’-dimethyl-N-

(methoxymethyl) acetanilide) and its

metabolites in or on the raw agricultural

commodity (RAC) sorghum forage at 2.0

parts per million (ppm). The Monsanto

Co. requested the establishment of this

maximum permissible residue of the

herbicide.

DATES: Comments, identified by the

document control number [PP 8F3671/

P610], 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 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-

6800; e-mail:

taylor.robert@epamail.epa.gov.
Federal Register / Vol. 60, No. 70 / Wednesday, April 12, 1995 / Proposed Rules 18559

SUPPLEMENTARY INFORMATION: EPA

issued a notice in the Federal Register

of October 12, 1988 (53 FR 39785), that

announced that the Monsanto Co., 1101

17th St., NW., Washington, DC 20036,

proposed amending 40 CFR 180.249 by

establishing a regulation under section

408 of the Federal Food, Drug, and

Cosmetic Act (FFDCA), 21 U.S.C. 346a,

to permit the residues of the herbicide

alachlor (2-chloro-2’,6’-dimethyl-N-

(methoxymethyl) acetanilide) and its

metabolites in or on sorghum forage at

2.0 parts per million (ppm) (pesticide

petition (PP) 8F3671). This increased

tolerance was necessary because review

of additional data submitted in response

to reregistration indicated that the

current tolerance of 1.0 for sorghum

forage was not adequate and needed to

be increased. EPA issued a notice in the

Federal Register of March 23, 1989 (54

FR 12010), which announced that the

Monsanto Co. proposed amending 40

CFR parts 185 and 186 by establishing

a regulation under section 409 of the

FFDCA, 21 U.S.C. 348, permitting

residues of the herbicide alachlor in or

on sorghum milling fractions at 0.5

ppm, sorghum milling fractions (except

germ) at 0.3 ppm, and sorghum germ at

0.5 ppm (food/feed additive (FAP)

9H5576).

No comments were received in

response to these notices of filing.

During the course of its review, the

Agency determined that the food/feed

additive tolerances for sorghum milling

fractions and sorghum germ were not

needed and that there is no current

evidence of use of sorghum milling

fractions as a human food and very

limited evidence of use of soghum

milling fractions as livestock feed. The

petitioner subsequently withdrew FAP

No. 9H5576. Because it has been longer

than 5 years since the original proposal,

the tolerance of 2.0 ppm for sorghum

forage is being proposed for 30 days

following the date of publication in the

Federal Register to allow for public

comment.

The data submitted in the petition

and other relevant material have been

evaluated. The pesticide is considered

useful for the purpose for which the

tolerance is sought. The toxicological

data listed below were considered in

support of the proposed tolerance.

1. Several acute toxicology studies

place technical alachlor in acute toxicity

category IV for primary eye and dermal

irritation and, acute toxicity category III

for acute oral, dermal, and inhalation.

2. A 1-year feeding study with dogs

fed dose levels of 0, 1, 3, and 10

milligrams/kilograms/day (mg/kg/day)

with a no-observed effect level (NOEL)

of 1.0 mg/kg/day based on hemosiderin

storage in kidney and spleen in males at

10 mg/kg.

3. A 2-year chronic feeding/

carcinogenicity study in rats fed

epichlorohydrin-free alachlor at dose

levels of 0, 0.5, 2.5, and 15 mg/kg/day

with a NOEL for nonneoplastic toxicity

at 2.5 mg/kg/day based on ocular lesions

and hepatoxicity at 10 mg/kg/day.

Carcinogenic effects included a nasal

turbinate tumor in females at 2.5 mg/kg/

day, significant increases in nasal

turbinate tumors in both males and

females at 15 mg/kg/day (highest dose

tested (HDT)) and a significant increase

in thymus lymphosarcomas and adrenal

pheochromocytomas in high-dose

females.

4. A second chronic feeding/

carcinogenic study with rats fed

alachlor, with epichlorohydrin, at dose

levels of 0, 14, 42, and 126 mg/kg/day

with a systemic NOEL of less than 14

mg/kg/day based on ocular lesions and

hepatotoxicity at 14 mg/kg/day.

Carcinogenic effects included increased

number of nasal turbinate tumor in

males and females at 42 mg/kg/day and

mg/kg/day, an increase in stomach

tumors in both sexes at 126 mg/kg/day,

and an increase in thyroid follicular

tumors in males at 126 mg/kg/day

(HDT).

5. A special chronic feeding study in

rats fed a dose level of 126 mg/kg/day.

Ocular lesions, mainly, the uveal

degeneration syndrome (UDS) occurred

in 100% of the animals at the end of the

study. This syndrome was irreversible

once it began. Alachlor was a positive

oncogen with increased nasal turbinate

tumors, stomach tumors, and thyroid

tumors.

6. An 18-month carcinogenicity study

in mice fed dose levels of 0, 26, 78, and

260 mg/kg/day with carcinogenic effects

(increased lung bronchiolaraveolar

tumors in females at 260 mg/kg/day).

7. A three-generation reproduction

study with rats fed dose levels of 0, 3,

10, 11, and 30 mg/kg/day with a

reproductive NOEL of 10 mg/kg/day

based on kidney effects in F2 and F3

pups at 30 mg/kg/day (HDT).

8. A developmental toxicity study in

rats fed dose levels of 0, 50, 150, and

400 mg/kg/day with a developmental

toxicity equal to a greater than 400 mg/

kg/day with a fetotoxic NOEL of 150

mg/kg/day based on an increase in postimplantation loss and a slight decrease

in mean number of viable fetuses at 400

mg/kg/day . The maternal toxicity NOEL

for this study is 150 mg/kg/day based on

soft stools, hair loss, anogenital staining,

and death at 400 mg/kg/day.

9. A developmental toxicity study in

rabbits fed doses of 50, 100, and 150

mg/kg/day with a developmental NOEL

greater than 150 mg/kg/day greater than

150 mg/kg/day. The maternal NOEL was

100 mg/kg/day based on reduced body

weight gain.

10. Mutagenicity studies include

several Ames Tests. Alachlor and its

metabolites were negative in four Ames

assays with Salmonella with and

without S9 activation at 0.1 to 10 mg/

plate. Two metabolites of alachlor were

positive in an Ames test with and

without S9 activation at 0.01 to 10 mg/

plate. Bile from alachlor-treated rates

did not induce a mutagenic response

towards Salmonella strains TA98,

TA100, TA1535, and TA1537. Other

mutagenicity tests include DNA

damage/repair in rat positive for UDS at

the HDT = LD50 at the 4 doses tested (50,

200, and 1,000 mg/kg)—weakly

genotoxic; gene mutation in CHO/

HGPRT—negative, and in vivo bone

marrow chromosome aberration assay—

negative.

Alachlor has been classified as a B2

carcinogen—‘‘Probable Human

Carcinogen’’ by the Agency. Alachlor

met all but one of the criteria specified

for the B2 classification. Alachlor

produced an increased incidence of

nasal turbinate tumors (mostly benign)

at the mid and high doses, in both sexes,

thyroid follicular tumors in male rats

and malignant stomach tumors in male

and female rats in Long-Evans rats in

three different experiments at more than

one dose level via dietary

administration. Alachlor also produced

a statistically significant increase in

lung tumors in female CD-1 mice at two

dose levels. In another experiment with

Long-Evans rats, nasal turbinate tumors

occurred only 5 to 6 months after

exposure. The tumor incidence was as

high at 50% and tumor site was

unusual, i.e., not an increase of normal

high background tumor type. A

metabolite of alachlor was mutagenic in

the Ames Test at 6 dose levels, and

alachlor is structurally similar to

acetochlor and metolachlor, two other

known carcinogens. A detailed

discussion of the Agency’s classification

of alachlor as a B2 carcinogen was

published in the Federal Register of

December 31, 1987 (52 FR 49480). The

publication was entitled ‘‘Alachlor,

Notice of Intent to Cancel Registrations,

Conclusion of Special Review.’’

For the purpose of risk

characterization of alachlor, the use of

the linearized multi-stage model, as

recommended to EPA’s Carcinogenic

Risk Assessment Guidelines, was

applied to the rat oncogenicity data

discussed above. As a result, the cancer

potency value for alachlor, known as the

‘‘Q*1’’, was calculated to be 8 X 10-2 or

0.08 (mg/kg/day)-1. Refer to the
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