Federal Register / Vol. 60, No. 100 / Wednesday, May 24, 1995 / Rules and Regulations 27417

paper record maintained at the address

in ‘‘ADDRESSES’’ at the beginning of

this document.

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 4, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR part 180 is

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(d) is amended in

the table therein by adding and

alphabetically inserting the inert

ingredient, to read as follows:

§ 180.1001 Exemptions from the

requirement of a tolerance.

* * * * *

(d) * * *

Inert ingredient Limits Uses

* * * * * * *

Acetic acid ethenyl ester, polymer with ethenol and (α)

-2-propenyl-(ω)-hydroxypoly (oxy-1,2-ethanediyl)

(CAS Reg. No.137091-12-4); minimum number average molecular weight 15,000.

................................................... Component of water-soluble film.

* * * * * * *

* * * * *

[FR Doc. 95–12567 Filed 5–23–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

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

3E4162/R2128; FRL–4950–3]

RIN 2070–AB78

2-[1-(Ethoxyimino)Butyl]-5-[2-

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

Cyclohexen-1-One; Pesticide

Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes

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 this regulation to establish

maximum permissible levels for

residues of the herbicide. These timelimited tolerances expire on December

31, 1996.

EFFECTIVE DATE: This regulation

becomes effective May 24, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 0E3909,

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

R2128], may be submitted to: Hearing

Clerk (1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk should be

identified by the document control

number and submitted 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 copy of objections and

hearing requests to: Rm. 1132, CM #2,

1921 Jefferson Davis Hwy., Arlington,

VA 22202.

A copy of objections and hearing

requests may also be submitted

electronically by sending electronic

mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

electronic objections and hearing

request must be submitted as an ASCII

file avoiding the use of special

characters and any form of encryption.

Copies of objections and hearing

requests will also be accepted on disks

in WordPerfect in 5.1 file format or

ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket number, [PP 0E3909, 2E4052,

2E4065, 2E4092, and 3E4162/R2128].

No Confidential Business Information

(CBI) should be submitted through email. Copies of electronic objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

below in this document.

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; e-mail:

jamerson.hoyt@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of March 15, 1995 (60

FR 13939), EPA issued a proposed rule

that gave notice that the the

Interregional Research Project No. 4 (IR4), New Jersey Agricultural Experiment

Station, P.O. Box 231, Rutgers

University, New Brunswick, NJ 08903,

had submitted pesticide petitions (PP)

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

3E4162 to EPA on behalf of various

Agricultural Experiment Stations.

These petitions requested 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 various raw agricultural

commodities.

There were no comments or requests

for referral to an advisory committee

received in response to the proposed

rule.

The data submitted on the proposal

and other relevant material have been

evaluated and discussed in the

proposed rule. Based on the data and

information considered, the Agency
27418 Federal Register / Vol. 60, No. 100 / Wednesday, May 24, 1995 / Rules and Regulations

concludes that the time-limited

tolerances will protect the public health.

Therefore, the time-limited tolerances

are established as set forth below.

Any person adversely affected by this

regulation may, within 30 days after

publication of this document in the

Federal Register, file written objections

and/or request a hearing with the

Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issue(s) on

which a hearing is requested, the

requestor’s contentions on such issues,

and a summary of any evidence relied

upon by the objector (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issue(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Under Executive Order 12866 (58 FR

51735, Oct. 4, 1993), the Agency must

determine whether the regulatory action

is ‘‘significant’’ and therefore subject to

review by the Office of Management and

Budget (OMB) and the requirements of

the Executive Order. Under section 3(f),

the order defines a ‘‘significant

regulatory action’’ as an action that is

likely to result in 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

referred to 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 the

rights and obligations of recipients

thereof; 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 the 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).

A record has been established for this

rulemaking under docket number [PP

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

3E4162/R2128] (including any

comments and data submitted

electronically as described below). A

public version of this record, including

printed, paper versions of electronic

comments, which does not include any

information claimed as CBI, is available

for inspection from 8 a.m. to 4:30 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, Crystal Mall #2,

1921 Jefferson Davis Highway,

Arlington, VA.

A copy of electronic objections and

hearing requests filed with the Hearing

Clerk can be sent directly to EPA at:

opp-Docket@epamail.epa.gov

A copy of electronic objections and

hearing requests filed with the Hearing

Clerk must be submitted as an ASCII file

avoiding the use of special characters

and any form of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any objections received

electronically into printed, paper form

as they are received and will place the

paper copies in the official rulemaking

record which will also include all

comments submitted directly in writing.

The official rulemaking record is the

paper record maintained at the address

in ADDRESSES at the beginning of this

document.

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 10, 1995.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR part 180 is

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) 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

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

on 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

on December 31, 1996, are established

for combined residues of the herbicide
Federal Register / Vol. 60, No. 100 / Wednesday, May 24, 1995 / Rules and Regulations 27419

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. 95–12744 Filed 5–23–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 2F4154/R2136; FRL–4955–3]

RIN 2070–AB78

Fenbuconazole; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for combined

residues of the fungicide fenbuconazole,

alpha-[2-(4-chlorophenyl)ethyl]-alphaphenyl-3-(1H-1,2,4-triazole)-1-

propanenitrile, and its metabolites cis-5-

(4-chlorophenyl)dihydro-3-phenyl-3-

(1H-1,2,4-triazole-1-ylmethyl)-2-3Hfuranone and trans-5-(4-

chlorophenyl)dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3Hfuranone, expressed as fenbuconazole,

in or on the raw agricultural commodity

bananas (whole fruit) at 0.3 ppm of

which not more than 0.05 ppm is

contained in the banana pulp. Rohm &

Haas Co. submitted petitions for this

regulation to establish a maximum

permissible level for residues of the

fungicide.

EFFECTIVE DATE: This regulation

becomes effective May 24, 1995..

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 2F4154/

R2136], may be submitted to: Hearing

Clerk (1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections shall be

labeled ‘‘Tolerance Petition Fees’’ and

forwarded to: EPA Headquarters

Accounting Operations Branch

(Tolerance Fees), P.O. Box 360277M,

Pittsburgh, PA 15251. A copy of any

objections and hearing request filed

with the Hearing Clerk should be

identified by the document control

number and submitted to: Public

Response and Program Resources

Branch, Field Operations Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20450. In

person, bring copy of objections and

hearing request to: Rm. 1132, CM #2,

1921 Jefferson Davis Hwy., Arlington,

VA 22202.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect in 5.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket number [PP 2F4154/R2136].

No Confidential Business Information

(CBI) should be submitted through email. Electronic copies of objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

below in this document.

FOR FURTHER INFORMATION CONTACT: By

mail: James M. Stone, Acting Product

Manager (PM) 22, Registration Division,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 229, CM #2, 1921 Jefferson Davis

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

5540; e-mail:

stone.james@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the

Federal Register of December 30, 1992

(57 FR 62334), which announced that

Rohm & Haas, Agricultural Chemicals,

Independence Mall West, Philadelphia,

PA 19105, had submitted a pesticide

petition (PP) 2F4154, to EPA requesting

that the Administrator, pursuant to

section 408(d) of the Federal Food, Drug

and Cosmetic Act (FFDCA), 21 U.S.C.

346a(d), amend 40 CFR part 180 by

establishing a regulation to permit

residues of fenbuconazole, alpha-[2-(4-

chlorophenyl)ethyl]-alpha-phenyl-3-

(1H-1,2,4-triazole)-1-propanenitrile, and

its metabolites [5-(4-chlorophenyl)-

dihydro-3-phenyl-3-(methyl-1H-1,2,4-

triazole-1-yl)-2-3H-furanone] in or on

bananas (pulp) at 0.05 part per million

(ppm) and bananas (peel) at 0.3 ppm.

Subsequently, on June 29, 1994 (59 FR

33503), EPA announced that Rohm &

Haas had amended the petition to

propose amending 40 CFR part 180 by

establishing a regulation to permit

residues of fenbuconazole, alpha-(2-(4-

chlorophenyl)ethyl)-alpha-phenyl-3-

(1H-1,2,4-triazole)-1-propanenitrile, and

its metabolites cis-5-(4-

chlorophenyl)dihydro-3-phenyl-3-(1H1,2,4-triazole-1-4-ylmethyl)-2-3Hfuranone and trans-5-(4-

chlorophenyl)dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3H-furanone

in or on bananas (whole fruit) at 0.3

ppm of which not more than 0.05 ppm

is contained in banana pulp.

There were no comments or requests

for referral to an advisory committee

received in response to these notices of

filing.

The scientific data submitted in the

petitions and all other relevant material

have been evaluated. The toxicology

data considered in support of the

tolerances include:

1. A rat acute oral study with an LD50

greater than 2 grams (g)/kilogram (kg).

2. A 13-week rat feeding study with

a no-observed-effect level (NOEL) of 20

ppm (1.3 milligrams(mg)/kg/day males

and 1.5 mg/kg/day females) and a

lowest-observed-effect level (LOEL) of

80 ppm (5.1 mg/kg/day males and 6.3

mg/kg/day females) based on

hepatotoxicity.

3. A 3-month mouse feeding study

with a NOEL of 20 ppm (3.8 mg/kg/day

males and 5.7 mg/kg/day females) and

a LOEL of 60 ppm (11.1 mg/kg/day

males and 17.6 mg/kg/day females)

based on hepatotoxicity.

4. A 3-month dog feeding study with

a NOEL of 100 ppm (3.3 mg/kg/day

males and 3.5 mg/kg/day females) and

LOEL of 400 ppm (13.3 mg/kg/day

males and 14.0 mg/kg/day females),

based hepatocellular hypertrophy.

5. A 21-day rat dermal study with a

NOEL greater than 1,000 mg/kg/day

(limit dose).

6. A 78-week dietary carcinogenicity

study in mice with a NOEL of 1.43 mg/

kg/day and a LOEL of 28.6 mg/kg/day

(males) and 92.9 mg/kg/day (females)

based on hepatocellular enlargement

and a greater incidence and severity of

hepatocellular vacuolation. There was

evidence of carcinogenicity based on the

occurrence of increased trend for

malignant liver tumors in males and an

increase in benign and malignant liver

tumors in females. The carcinogenic

effects observed are discussed below.

7. A 24-month rat chronic feeding/

carcinogenicity study with a NOEL of 80

ppm (3.03 mg/kg/day for males and 4.02

mg/kg/day for females) for systemic

effects and an LEL of 800 ppm (30.62

mg/kg/day for males and 43.07 mg/kg/

day for females) based on decreased in

body weights in females, and increased

liver weighs in females and males along

with hepatocellular enlargement and