Federal Register / Vol. 60, No. 104 / Wednesday, May 31, 1995 / Rules and Regulations 28345

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 and hearing

requests 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 objections and hearing

requests submitted directly in writing.

The official rulemaking record is the

paper record maintained at the address

in ADDRESSES at the beginning of this

document.

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).

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 18, 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. 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. 95–13249 Filed 5–30–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 4F4280/R2135; FRL–4954–4]

RIN 2070–AB78

Benzoic Acid; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes a

tolerance for residues of the insecticide

benzoic acid, 3,5-dimethyl-1-(1,1-

dimethylethyl)-2-(4-

ethylbenzoyl)hydrazide, in or on the

raw agricultural commodity walnuts.

The Rohm & Haas Co. requested this

regulation pursuant to the Federal Food,

Drug and Cosmetic Act (FFDCA). The

regulation establishes a maximum

permissible level for residues of benzoic

acid in or on the commodity.

EFFECTIVE DATE: This regulation

becomes effective May 31, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 4F4280/

R2135], 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, 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 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 4F4280/R2135].

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: Richard P. Keigwin, Jr., Product

Manager (PM) 10, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 214, CM #2, 1921 Jefferson Davis

Highway, Arlington, VA 22202, (703)-

305-7001; e-mail:

Keigwin.rick@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the

Federal Register of April 5, 1995 (60 FR

17357), which announced that Rohm &

Haas Co. had submitted pesticide

petition PP 4F4280 to EPA requesting

that the Administrator, pursuant to

section 408(d) of the Federal Food,
28346 Federal Register / Vol. 60, No. 104 / Wednesday, May 31, 1995 / Rules and Regulations

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a(d), establish a tolerance for

residues of the insecticide benzoic acid,

3,5-dimethyl-1,1-(1,1-dimethylethyl)-2-

(4-ethylbenzoyl)hydrazide, in or on the

raw agricultural commodity walnuts at

0.1 part per million (ppm).

The scientific data submitted in the

petition and other relevant material

have been evaluated. The toxicological

data considered in support of the

tolerance include:

1. A 1-year dog feeding study with a

lowest-observable-effect level (LOEL) of

250 ppm (9 mg/kg/day for male and

female dogs ) based on decreases in

RBC, HCT, and HGB, increases in Heinz

bodies, methemoglobin, MCV, MCH,

reticulocytes, platelets, plasma total

bilirubin, spleen weight, and spleen/

body weight ratio, and liver weight and

liver/body weight ratio. Hematopoiesis

and sinusoidal engorgement occurred in

the spleen, and hyperplasia occurred in

the marrow of the femur and sternum.

The liver showed an increased pigment

in the Kupffer cells. The no-observableeffect level (NOEL) for systemic toxicity

in both sexes is 50 ppm (1.9 mg/kg/day).

2. An 18-month mouse

carcinogenicity study with no

carcinogenicity observed at dosage

levels up to and including 1,000 ppm.

3. A 2-year rat carcinogenicity study

with no carcinogenicity observed at

dosage levels up to and including 2,000

ppm (97 mg/kg/day and 125 mg/kg/day

for males and females, repectively).

4. A two-generation rat reproduction

study with a NOEL of 150 ppm (12.1

mg/kg/day) for reproductive effects

compared to a systemic NOEL of 10

ppm (0.85 mg/kg/day).

5. A rat developmental study with a

NOEL of 1,000 mg/kg/day for

developmental toxicity.

6. A rabbit developmental study with

a NOEL of 1,000 mg/kg/day for

developmental toxicity.

7. Several mutagenicity tests which

were all negative. These include an

Ames assay with and without metabolic

activation, an in vivo cytogenetic assay

in rat bone marrow cells, an in vitro

chromosome aberration assay in CHO

cells, a CHO/HGPRT assay, a reverse

mutation assay with E. coli, and an

unscheduled DNA synthesis assay

(UDS) in rat hepatocytes.

The reference dose (RfD), for chronic

toxicity as defined in a 1-year chronic

dog study is 0.019 mg/kg/day based

upon a NOEL of 1.9 mg/kg/day in dogs

of both sexes and applying an

uncertainty factor of 100. The

theoretical maximum residue

contribution (TMRC) for this first food

use of benzoic acid, 3,5-dimethyl-1-(1,1-

dimethylethyl)-2-(4-

ethylbenzoyl)hydrazide on walnuts for

the overall U.S. population is less than

0.000001 mg/kg/day and represents

0.003% of the RfD. The TMRC for the

highest exposed subgroup, children

(ages 1 6 years old), is less than

0.000001 mg/kg/day and represents

0.008% of the RfD.

The metabolism of benzoic acid, 3,5-

dimethyl-1-(1,1dimethylethyl)-2-(4-

ethylbenzoyl)hyrazide, is adequately

understood. An adequate analytical

method, HPLC separation with UV

detection, is available for enforcement

purposes and is being provided to FDA

for inclusion in the Pesticide Analytical

manual, Vol. II.

There are currently no actions

pending against the registration of this

chemical. There is no expectation of

residues occurring in meat, milk,

poultry, or eggs from this tolerance.

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

tolerance is 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

to the regulation and may also request

a hearing on those objections.

Objections and hearing requests must be

filed 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 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).

A record has been established for this

rulemaking under docket number [PP

4F4280/R2135] (including objections

and hearing requests 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

Rm. 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.

Written objections and hearing

requests, identified by the document

control number [PP 4F4280/R2135],

may be submitted to the Hearing Clerk

(1900), Environmental Protection

Agency, Rm. 3708, 401 M St., SW.,

Washington, DC 20460.

A copy of electronic objections and

hearing requests can be sent directly to

EPA at:

opp-Docket@epamail.epa.gov

A copy of electronic objections and

hearing requests 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 and hearing

requests 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 objections and hearing

requests submitted directly in writing.

The official rulemaking record is the

paper record maintained at the address

in ADDRESSES at the beginning of this

document.

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
Federal Register / Vol. 60, No. 104 / Wednesday, May 31, 1995 / Rules and Regulations 28347

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: May 12, 1995.

Daniel M. Barolo,

Director, 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. By adding new § 180.842, to read as

follows:

§ 180.842 Benzoic acid; tolerances for

residues.

A tolerance is established for residues

of the insecticide benzoic acid, 3,5-

dimethyl-1-(1,1-dimethylethyl)-2-(4-

ethylbenzoyl)hydrazide, in or on the

following raw agricultural commodity:

Commodity Parts per

million

Walnuts ..................................... 0.1

[FR Doc. 95–13250 Filed 5–30–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 2E4051/R2136; FRL–4955–5]

RIN 2070–AB78

Difenoconazole; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes

import tolerances for residues of the

fungicide difenoconazole in or on the

raw agricultural commodities barley

grain, rye grain, and wheat grain at 0.1

part per million (ppm); fat, meat, and

meat byproducts of cattle, goats, hogs,

horses, poultry, and sheep and eggs at

0.05 ppm; and milk at 0.01 ppm. CibaGeigy Corp. requested this regulation

pursuant to the Federal Food, Drug and

Cosmetic Act (FFDCA). The regulation

establishes the maximum permissible

level for residues of the fungicide in or

on the commodities.

EFFECTIVE DATE: This regulation

becomes effective May 31, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 2E4051/

R2136], 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 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 2E4051/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 Stone, Acting Product

Manager (PM) 22, Registration Division

(7505C), Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location and telephone

number: Rm. 259, 1921 Jefferson Davis

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

7391; e-mail:

stone.james@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of April 12, 1995 (60

FR 18555), EPA issued a proposed rule

that gave notice that Ciba-Geigy Corp.,

P.O. Box 18300, Greensboro, NC 27419-

8300, had petitioned EPA under section

408 of the FFDCA, 21 U.S.C. 346a, to

establish import tolerances under 40

CFR 180.475 for residues of the

fungicide difenoconazole, [(2S,4R)/

(2R,4S)]/[(2R,4R/2S,4S)] 1-(2-[4-(4-

chlorophenoxy)-2-chlorophenyl]-4-

methyl-1,3-dioxolan-2-yl-methyl)-1H1,2,4-triazole, in or on the raw

agricultural commodities (RACs) barley

grain, rye grain, and wheat grain at 0.1

ppm; fat, meat, and meat byproducts

(mbyp) of cattle, goats, hogs, horses,

poultry, and sheep and eggs at 0.04

ppm; and milk at 0.01 ppm.

There were no comments or requests

for referral to an advisory committee

received in response to the proposed

rule.

The data submitted with the proposal

and other relevant material have been

evaluated and discussed in the

proposed rule. Based on the data and

information considered, the Agency

concludes that the tolerances will

protect the public health. Therefore, the

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