Federal Register / Vol. 60, No. 31 / Wednesday, February 15, 1995 / Proposed Rules 8615

2. In § 180.368, paragraph (a) is

amended by adding and alphabetically

inserting the entry for celery, and

paragraph (c) is amended by adding and

alphabetically inserting the entry for

onion (dry bulb), to read as follows:

§ 180.368 Metolachlor; tolerances for

residues.

(a) * * *

Commodity Parts per

million

* * * * *

Celery ........................................ 0.1

* * * * *

* * * * *

(c) * * *

Commodity Parts per

million

Onion (dry bulb) ........................ 1.0

* * * * *

[FR Doc. 95–3386 Filed 2–14–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 6E3460/P597; FRL–4932–2]

RIN 2070–AB78

Pesticide Tolerance for Prometryn

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish a

tolerance for residues of the herbicide

prometryn in or on the raw agricultural

commodity parsley. 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

document control number [PP 6E3460/

P597], must be received on or before

March 17, 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: 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)

6E3460 to EPA on behalf of the

Agricultural Experiment Station of

California. 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 180.222 by

establishing a tolerance for residues of

the herbicide prometryn (2,4-

bis(isopropylamino)-6-methylthio-striazine) in or on the raw agricultural

commodity parsley at 0.1 part per

million (ppm). The petitioner proposed

that use of prometryn on parsley be

limited to California only 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.

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 2-year feeding study with dogs

fed diets containing 0, 15, 150, or 1,500

ppm (equivalent to 0, 0.375, 3.75, or

37.5 milligrams (mg)/kilogram (kg)/day)

with a no-observed-effect level (NOEL)

of 150 ppm (3.75 mg/kg/day) based on

degenerative hepatic changes, renal

tubule degeneration, and bone marrow

atrophy at the 1,500-ppm dose level.

2. A 104-week chronic feeding/

carcinogenicity study with rats fed diets

containing 0, 10, 100, 750, or 1,500 ppm

(equivalent to 0, 0.38, 3.90, 29.45, or

60.88 mg/kg/day for males and 0, 0.49,

4.91, 37.25, or 80.62 mg/kg/day for

females) with a systemic NOEL of 750

ppm (29.45 mg/kg/day in males and

37.25 mg/kg/day in females) based on

decreased body weight gain in both

sexes, and renal lesions (mineralized

concretions) in males at the 1,500-ppm

dose level. There were no carcinogenic

effects observed under the conditions of

the study.

3. A carcinogenicity study with mice

fed diets containing 0, 10, 1,000, or

3,000 ppm (equivalent to 0, 1, 100, or

300 mg/kg/day) for 102 weeks with a

systemic NOEL of 1,000 ppm (100 mg/

kg/day) based on decreased body weight

gain in female mice at the 3,000-ppm

dose level. There were no carcinogenic

effects observed under the conditions of

the study.

4. A two-generation reproduction

study in rats fed diets containing 0, 10,

750, or 1,500 ppm (equivalent to 0, 0.6,

47.8, 96.7 mg/kg/day in males and 0,

0.7, 53.6, or 105.6 mg/kg day in females)

with a NOEL for reproductive effects of

10 ppm (0.6 mg/kg/day in males and 0.7

mg/kg/day in females) based on

decreased pup weight at the 750-ppm

dose level. The NOEL for parental

systemic toxicity was also established at

10 ppm based on decreased food

consumption, body weight, and body

weight gain at the 750-ppm dose level.

5. A developmental toxicity study in

rabbits given gavage doses of 0, 2, 12, or

72 mg/kg/day with a NOEL of 12 mg/kg/

day for maternal toxicity based on

decreased food consumption at the

highest dose tested (72 mg/kg/day). The

NOEL for developmental effects was

established at 12 mg/kg/day based on

increased fetal resorption at the highest

dose tested.

6. A developmental toxicity study in

rats given gavage doses of 0, 10, 50, or

250 mg/kg/day during gestational days 6

to 15 with a NOEL of 50 mg/kg/day for

maternal toxicity based on salivation

and decreases in body weight and food

consumption at the highest dose tested

(250 mg/kg/day). A NOEL for

developmental toxicity was established

at 50 mg/kg/day based on decreased

fetal body weight and increased

incomplete ossification of sternebrae

and metacarpals at the 250-mg/kg/day

dose level.

7. Mutagenicity studies as follows: a

gene mutation test (Ames assay),

negative up to cytotoxic solubility

limits; structural chromosome

aberration tests, negative for anomalies

in micronuclei in bone marrow cells of
8616 Federal Register / Vol. 60, No. 31 / Wednesday, February 15, 1995 / Proposed Rules

Chinese hamsters dosed orally at 5,000

mg/kg; and tests for other genotoxic

effects, negative for unscheduled DNA

synthesis in rat hepatocytes up to

cytotoxic levels.

8. In a general metabolism study using

rats fed diets containing radio-labelled

prometryn, prometryn was extensively

metabolized with less than 2 percent of

the recovered 14C radioactivity

representing the parent compound.

Prometryn is excreted predominately in

the urine and feces.

The Reference Dose (RfD) for

prometryn is established at 0.04 mg/kg

of body weight (bwt)/day, based on a

NOEL of 3.75 mg/kg/day from the 2-year

feeding study in dogs and an

uncertainty factor of 100. The

Theoretical Maximum Residue

Contribution (TMRC) from established

tolerances and the current action is

estimated at 0.000181 mg/kg of body

weight/day and utilizes less than 1

percent of the RfD for the U.S.

population. The most highly exposed

subgroup (children of ages 1 through 6

years) will be exposed to less than 1

percent of the RfD from existing uses

and the proposed use on parsley.

An acute dietary exposure analysis

was conducted for prometryn based on

a NOEL of 12 mg/kg/day from the rabbit

developmental toxicity study. In the

analysis, tolerance level residues were

used to calculate the high-end exposure

for females older than 13 years, which

approximates women of child-bearing

age. High-end dietary exposure was

compared to the NOEL of 12 mg/kg/day

to obtain a high-end Margin of Exposure

(MOE) of 10,000. The Agency concludes

there is no acute dietary concern for

prometryn at this time.

The nature of residue in plants is

adequately understood for the purposes

of the proposed tolerance. An adequate

analytical method, gas chromatography,

is available for enforcement purposes.

The analytical method for enforcing this

tolerance has been published in the

Pesticide Analytical Manual, Vol. II

(PAM II).

There is no reasonable expectation

that secondary residues will occur in

milk, eggs, or meat of livestock and

poultry, since there are no livestock feed

items associated with this action.

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 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 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 6E3460/P597]. 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: January 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 § 180.222, paragraph (b) is

amended in the table therein by adding

and alphabetically inserting a new

entry, to read as follows:

§ 180.222 Prometryn; tolerances for

residues.

* * * * *

(b) * * *

Commodity Parts per

million

* * * * *

Parsley ...................................... 0.1

[FR Doc. 95–3385 Filed 2–14–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 300

[FRL–5154–4]

National Oil and Hazardous

Substances Contingency Plan; The

National Priorities List Update

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of intent to delete the

Cemetery Dump site, Rose Township,

Michigan from the National Priorities

List; request for comments.

SUMMARY: The Environmental Protection

Agency (EPA) Region V announces its

intent to delete the Cemetery Dump site,

Rose Township, Michigan from the

National Priorities List (NPL) and

requests public comment. The NPL is

Appendix B to the National Oil and

Hazardous Substances Contingency Plan

(NCP), which EPA promulgated

pursuant to section 105 of the

Comprehensive Environmental

Response, Compensation, and Liability

Act of 1980 (CERCLA) as amended. This

action is being taken by EPA, because it

has been determined that all Fund-