Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Proposed Rules 20471

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: April 13, 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 § 180.1(h) by amending the table

therein by revising the entry for summer

squash, to read as follows:

§ 180.1 Definitions and interpretations.

* * * * *

(h) * * *

A B

* * * * * * *

Summer squash .................................... Fruits of the gourd (Cucurbitaceae) family that are consumed when immature, 100% of the fruit is edible either cooked or raw, once picked it cannot be stored, has a soft rind which is easily penetrated,

and if seeds were harvested they would not germinate; e.g., Cucurbita pepo (i.e, crookneck squash,

straightneck squash, scallop squash, and vegetable marrow); Lagenaria, spp. (i.e., spaghetti squash,

hyotan, cucuzza); Luffa spp. (i.e., hechima, Chinese okra); Momordica spp. (i.e., bitter melon, balsam pear, balsam apple, Chinese cucumber); Sechium edule (chayote); and other cultivars and/or

hybrids of these.

* * * * * * *

* * * * *

[FR Doc. 95–10253 Filed 4–25–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 3E4249/P613; FRL–4949–2]

RIN 2070–AC18

Fenarimol; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish a

tolerance for the combined residues of

the fungicide fenarimol in or on the

imported raw agricultural commodity

bananas at 0.5 part per million (ppm).

Not more than 0.25 ppm shall be

present in the pulp after the peel is

removed. DowElanco petitioned for this

regulation to establish a maximum

permissible level for combined residues

of the fungicide.

DATES: Comments, identified by the

document control number [PP 3E4249/

P613], must be received on or before

May 26, 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

a copy of the 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: Connie B. Welch, Product

Manager (PM) 21, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 227, CM #2, 1921 Jefferson Davis

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

6900; e-mail:

welch.connie@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA is

proposing to establish an import

tolerance for the combined residues of

the fungicide fenarimol, [alpha-(2-

chlorophenyl)-alpha-(4-chlorophenyl)-

5-pyrimidinemethanol] and its

metabolites [alpha-(2-chlorophenyl)-

alpha-(4-chlorophenyl)-1,4-dihydro-5-

pyrimidinemethanol and 5-(2-

chlorophenyl)-(4-chlorophenyl)methyl]-

3,4-dihydro-4-pyrimidinol measured as

the total of fenarimol and 5-[(2-

chlorophenyl)-(4-

chlorophenyl)methyl]pyrimidine

(calculated as fenarimol)], in or on the

raw agricultural commodity bananas at

0.5 part per million (ppm). Not more

than 0.25 ppm shall be present in the

pulp after the peel is removed. The

proposed regulation to establish a

maximum permissible level of the

fungicide pursuant to section 408(e) of

the Federal Food, Drug, and Cosmetic

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

amending 40 CFR 180.421 to include

this commodity was requested in a

pesticide petition, PP 3E4249, submitted

by DowElanco, 9002 Purdue Rd.,

Indianapolis, IN 46268-1189. 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 the following:

1. A 1-year dog-feeding study using

doses of 0, 1.25, 12.5, and 125

milligrams/kilogram (mg/kg) body

weight (bwt)/day. The no-observedeffects level (NOEL) is 12.5 mg/kg bwt/

day. The 125 mg/kg bwt/day dose level

caused increased serum alkaline

phosphatase, increased liver weights,

increased p-nitroanisole o-demethylase

activity, and mild hepatic bile stasis.

2. An initial 2-year chronic feeding/

oncogenicity study in rats using dietary

concentrations of 0, 50, 130, and 350

ppm (equivalent to doses of 0, 2.5, 6.5,

and 17.5 mg/kg bwt/day). In a Federal

Register document published in the

issue of March 5, 1986 (51 FR 7567), the

Agency indicated fenarimol to be

oncogenic. In that document, the

Agency’s initial conclusion that

fenarimol was oncogenic was based on

a finding in the 2-year rat study of a

statistically significant increase in

hepatic lesions (adenomas and
20472 Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Proposed Rules

hyperplastic nodules) at the highest

dose tested (17.5 mg/kg bwt/day), when

data for male and female rats were

combined.

Since that time, the compound has

been reevaluated. The Agency now

considers it more appropriate to

separate data for males and females and

also to separate hyperplastic nodules

from tumors (adenomas and

carcinomas). When a reevaluation of the

hepatic lesions for males and females

was performed separately with the

elimination of hyperplastic nodules, the

data did not demonstrate a statistically

significant increased incidence in

adenomas and/or carcinomas in either

sex. Moreover, the mouse oncogenicity

study did not demonstrate oncogenic

potential at dose levels up to and

including a dose level of 85.7 mg/kg

bwt/day (the highest dose level tested).

Because of the appearance of a low

incidence of fatty change of the liver

(nonneoplastic pathological lesions) in

the low-dose groups in this study, it was

unclear if a NOEL for fatty change of the

liver was established in this study.

3. Additional 2-year chronic feeding/

oncogenicity studies in rats using

dietary concentrations of 0, 12.5, 25,

and 50 ppm (equivalent to doses of 0,

0.63, 1.25, and 2.5 mg/kg bwt/day). The

purpose of these additional studies was

to assist in determining a NOEL for fatty

liver changes. The first of these two

studies was compromised, however, by

an outbreak of chronic respiratory

disease which reduced survival in all

experimental groups, including

controls. The study was then repeated

with the same dose levels. In the second

study, no fatty liver changes or

oncogenic effects were observed at the

doses tested under the conditions of the

study. Using data from all three 2-year

studies, a NOEL for fatty liver change of

6.5 mg/kg bwt/day was established.

4. A 2-year oncogenicity study in

mice using dietary concentrations of 0,

50, 170, and 600 ppm (equivalent to 0,

7, 24.3, and 85.7 mg/kg bwt/day) that

was negative for oncogenic effects at all

doses tested under the conditions of the

study. At 600 ppm, an increase in fatty

change of the liver was demonstrated.

The NOEL for this effect was 170 ppm

(24.3 mg/kg bwt/day).

5. A rabbit teratology study that was

negative for teratogenic effects at all

doses tested (0, 5, 10, and 35 mg/kg).

6. A rat teratology study that

demonstrated hydronephrosis at 35 mg/

kg (doses tested were 0, 5, 13, and 35

mg/kg). A second study in rats (with a

postpartum evaluation) again

demonstrated hydronephrosis at 35 mg/

kg, but also indicated that the dose level

of 35 mg/kg was associated with a

maternal toxic effect (decreased body

weight gain during treatment). The

Agency considers the NOEL for

hydronephrosis and for maternal

toxicity to be 13 mg/kg.

7. A multigeneration reproduction

study in rats that demonstrated

decreased fertility in males and delayed

parturition and dystocia in females at 5

mg/kg bwt/day. The NOEL for

reproductive effects in this study was

2.5 mg/kg bwt/day.

8. Multigeneration reproduction

studies in guinea pigs and mice that

were negative for reproductive effects at

doses up to 35 mg/kg bwt/day (highest

dose tested) and 20 mg/kg bwt/day,

respectively.

9. An aromatase inhibition study in

rats that showed fenarimol to be a

moderately weak inhibitor of aromatase

activity.

The adverse reproductive effects

observed in the rat multigeneration

reproduction study are considered to be

a species-specific effect caused by

aromatase inhibition. This enzyme

promotes normal sexual behavior in rats

and mice, but not in guinea pigs,

primates, or man. A NOEL of 35 mg/kg

bwt/day for reproductive effects

relevant to humans was established in

the multigeneration reproduction study

in guinea pigs.

10. A mouse lymphoma forward

mutation assay, a DNA repair synthesis

study in rat liver culture systems, gene

mutation assays in Salmonella

typhimurium (Ames test) and

Escherichia coli, a dominant-lethal

assay in Wistar rats, an assay for

transformation activity in the C3H/10T

1/2 embryonic mouse fibroblast, and an

in vivo assay for chromosome aberration

in the Chinese hamster. Fenarimol did

not demonstrate mutagenic activity in

any of these studies. Furthermore,

fenarimol did not induce altered foci or

neoplastic nodules in an initiation and

promotion study in rat liver tissue.

Based on the above findings, the

Agency concluded that fenarimol was

not oncogenic in long-term studies in

rats and mice under the test conditions

in which the highest dose tested for

both species approached a maximumtolerated dose as evidenced by

increased fatty change in the liver.

The acceptable daily intake (ADI)

based on the 2-year rat chronic feeding

study (NOEL of 6.5 mg/kg bwt/day) with

an uncertainty factor of 100 is

calculated to be 0.065 mg/kg bwt/day.

The theoretical maximum residue

contribution (TMRC) from previously

established tolerances and the tolerance

established here is 0.000431 mg/kg/day

for the general population and utilizes

0.66% of the ADI. The percentage of the

ADI for the most highly exposed

subgroup, non-nursing infants (less than

1 year old), is 2.68%. The TMRC was

calculated based on the assumption that

fenarimol occurs at the maximum legal

limit in all of the dietary commodities

for which tolerances are proposed. Even

with this probable large overestimate of

exposure/risk, the TMRC is well below

the ADI for the population as a whole

and for each of the 22 subgroups

considered. Thus, the dietary risk from

exposure to fenarimol appears to be

minimal.

The nature of the residues is

adequately understood, and adequate

analytical methodology is available for

enforcement. Prior to their publication

in the Pesticide Analytical Manual, Vol.

II, the enforcement methodology is

being made available in the interim to

anyone who is interested in pesticide

enforcement when requested from:

Calvin Furlow, Public Information

Branch, Field Operations Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm 1128C, CM 2, 1921 Jefferson Davis

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

5232.

The pesticide is considered useful for

the purpose for which the tolerance is

sought. Based on the information and

data considered, the Agency has

determined that the tolerance

established by amending 40 CFR part

180 will protect the public health.

Therefore, the tolerances are established

as set forth below. By way of public

reminder, this notice also reiterates the

registrant’s responsibility under section

6(a)(2) of FIFRA, to submit additional

factual information regarding adverse

effects on the environment and to

human health by these pesticides.

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 3E4249/P613]. 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
Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Proposed Rules 20473

8 a.m. to 4 p.m., Monday through

Friday, except legal holidays.

Under Executive Order 12866 (58 FR

51735, October 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: April 17, 1995.

Donald R. Stubbs,

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. In § 180.421(b) by revising the table

therein, to read as follows:

§ 180.421 Fenarimol; tolerances for

residues.

* * * * *

(b) * * *

Commodity Parts per million

Bananas1 ....... 0.5 (Not more than 0.25 ppm

shall be present in the

pulp after peel is removed)

Cherries ......... 1.0.

Grapes ........... 0.2.

1There are no United States registrations for

bananas as of April 26, 1995.

[FR Doc. 95–10252 Filed 4–21–95; 2:56 pm]

BILLING CODE 6560–50–F

40 CFR Part 300

[FRL–5196–8]

National Oil and Hazardous

Substances Pollution Contingency

Plan; National Priorities List

AGENCY: Environmental Protection

Agency.

ACTION: Notice of Intent to Delete the

Jackson Township Landfill Superfund

Site from the National Priorities List;

Request for Comments.

SUMMARY: The United States

Environmental Protection Agency

(EPA), Region II, announces its intent to

delete the Jackson Township Landfill

Site from the National Priorities List

(NPL) and requests public comment on

this action. The NPL constitutes

Appendix B of 40 CFR Part 300 which

is the National Oil & Hazardous

Substances Pollution Contingency Plan

(NCP), which EPA promulgated

pursuant to Section 105 of the

Comprehensive Environmental

Response, Compensation, and Liability

Act of 1980 (CERCLA), as amended.

EPA and the New Jersey Department of

Environmental Protection (NJDEP) have

determined that no further remedial

action by the responsible party is

appropriate under CERCLA. In addition,

EPA and NJDEP have determined that

remedial activities conducted to date at

the site have been protective of public

health, welfare, and the environment.

DATES: Comments concerning the

deletion of the Jackson Township

Landfill Site from the NPL may be

submitted on or before May 26, 1995.

ADDRESSES: Comments should be

submitted to: Joseph Gowers, Remedial

Project Manager, U.S. Environmental

Protection Agency, Region II, 290

Broadway, 19th Floor, New York, New

York 10007–1866.

Comprehensive information on the

Jackson Township Landfill Site is

contained in the NJDEP public docket

and is available for viewing, by

appointment only, at: NJDEP-Bureau of

Community Relations, 401 East State

Street, CN 413, Trenton, NJ 08625,

Phone: (609) 984–3081, 8.30 AM to 4.30

PM—Monday through Friday (excluding

holidays), Contact: Donald Kakas.

Information on the Site is also

available for viewing at the Jackson

Township Landfill Site Administrative

Record Repositories located at:

Jackson Township Municipal Complex,

RD#4, Box 1000, Jackson, NJ 08527,

Monday-Friday: 9am–5pm, (908) 928–

1200

Ocean County Library, 101 Washington

Street, Toms River, NJ 08753,

Monday-Friday: 9am–9pm, Saturday:

9am-5pm (908) 349–6200

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction

II. NPL Deletion Criteria

III. Deletion Procedures

IV. Basis for Intended Site Deletion

I. Introduction

EPA Region II announces its intent to

delete the Jackson Township Landfill

Site from the NPL and requests public

comment on this deletion. The NPL is

Appendix B to the NCP, which EPA

promulgated pursuant to Section 105 of

CERCLA, as amended. EPA identifies

sites that appear to present a significant

risk to public health, welfare, or the

environment and maintains the NPL as

the list of those sites. Sites on the NPL

may be the subject of remedial actions

financed by the Hazardous Substances

Superfund Response Trust Fund (the

Fund). Pursuant to § 300.425(e)(3) of the

NCP, any site deleted from the NPL

remains eligible for Fund-financed

remedial actions, if conditions at the

site warrant such action.

EPA will accept comments

concerning the deletion of the Jackson

Township Landfill Site from the NPL for

30 days after publication of this notice

in the Federal Register until May 26,

1995.

Section II of this notice explains the

criteria for deleting sites from the NPL.

Section III discusses procedures that

EPA is using for this action. Section IV

discusses how the Jackson Township

Landfill Site meets the NPL deletion

criteria.

II. NPL Deletion Criteria

The NCP establishes the criteria that

the Agency uses to delete sites from the