Federal Register / Vol. 60, No. 70 / Wednesday, April 12, 1995 / Proposed Rules 18555

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 170

[OPP–250103; FRL–4948–5]

RIN No. 2070–AC69 and 2070–AC82

Amendments to the Worker Protection

Standard Requirements for Crop

Advisors and Training Requirements

for Agricultural Workers and Pesticide

Handlers; Notification to Secretary of

Agriculture

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notification to Secretary of

Agriculture.

SUMMARY: Notice is given that the

Administrator of EPA has forwarded to

the Secretary of Agriculture a final rule

amending the crop advisor provisions of

the Worker Protection Standard and a

final rule amending the training

requirements for workers and pesticide

handlers. These final rules are being

issued under the Federal Insecticide,

Rodenticide, and Fungicide Act

(FIFRA).

FOR FURTHER INFORMATION CONTACT:

Donald Eckerman, Certification and

Training, Occupational Safety Branch

(7506C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm 1101, CM #2, 1921 Jefferson Davis

Highway, Arlington, VA., (703) 305–

7371.

SUPPLEMENTARY INFORMATION: Pursuant

to Section 25(a)(2)(B) of FIFRA, the

Administrator shall provide the

Secretary of Agriculture with a copy of

any final rule before publication in the

Federal Register. If the Secretary

comments in writing to the

Administrator regarding the final rule,

the Administrator shall issue for

publication in the Federal Register,

with the final rule, the comments of the

Secretary of Agriculture, if requested by

the Secretary, and the response of the

Administrator concerning the

Secretary’s comments. The

Administrator has forwarded to the

Secretary of Agriculture a copy of the

final rule amending the requirements for

training employees and a final rule

amending the requirements for crop

advisors.

The Administrator has also provided

a copy of these final rules to the

Committee on Agriculture of the House

of Representatives, and the Committee

on Agriculture and Forestry of the

Senate.

List of Subjects in 40 CFR Part 170

Administrative Practice and

Procedures, Occupational Safety and

Health, Pesticides and Pests.

Dated: April 5, 1995.

Daniel M. Barolo,

Director, Office of Pesticide Programs.

[FR Doc. 95–9167 Filed 4–11–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 2E4051/P608; FRL–4943–1]

RIN 2070–AC18

Difenoconazole; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish

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; 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. Ciba-Geigy

Corp. requested the proposed regulation

to establish a maximum permissible

level of the fungicide in or on the

commodities.

DATES: Comments, identified by the

document control number, [PP 2E4051/

P608], 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 Highway, Arlington, VA

22202. Information submitted as a

comment concerning this notice 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: Cynthia Giles-Parker, 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: gilesparker.cynthia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA is

proposing to establish import tolerances

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 0.05

ppm; and milk at 0.01 ppm. The

proposed regulation to establish a

maximum permissible level of the

fungicide in or on this commodity was

requested in a pesticide petition (PP

2E4051) submitted by Ciba-Geigy Corp.,

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

8300, that 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 180.475 by

establishing import tolerances for

residues of the fungicide.

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 rat acute oral study with an LD50

of 1,453 milligrams (mg)/kilogram (kg).

2. A 13-week rat feeding study with

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

ppm (1 mg/kg/day).

3. A 13-week mouse feeding study

with a NOEL of 20 ppm (3.6 mg/kg/day).

4. A 26-week dog feeding study with

a NOEL of 1,000 ppm (3.3 mg/kg/day).

5. A 21-day rabbit dermal study with

a NOEL of 10 mg/kg and reduction in

body weight gain and food consumption

from exposure to doses equal to or

greater than 100 mg/kg.

6. A carcinogenicity study in mice

with a NOEL of 30 ppm (5 mg/kg/day)

and a lowest-effect-level (LEL) of 300

ppm (50 mg/kg/day) owing to

reductions in cumulative body weights.

There was limited evidence of

carcinogenicity based on the occurrence

of increased benign and/or malignant

liver tumors in males and females. The

carcinogenic effects observed are

discussed below.
18556 Federal Register / Vol. 60, No. 70 / Wednesday, April 12, 1995 / Proposed Rules

7. A rat chronic feeding/

carcinogenicity study with a NOEL of 20

ppm (1 mg/kg/day) for systemic effects

and a LEL of 500 ppm (25 mg/kg/day)

owing to reductions in cumulative body

weight gains and hepatotoxicity in

males. There was no evidence of

carcinogenicity under conditions of the

study.

8. A 1-year dog chronic feeding study

with a NOEL of 100 ppm (3.5 mg/kg/

day); the LEL was 500 ppm (18 mg/kg/

day) owing to reduction in food

consumption and increase in alkaline

phosphatase in males at high dose.

9. A two generation reproduction

study in rats with a parental and

reproductive NOEL of 25 ppm (1.25 mg/

kg/day) and an LEL of 250 ppm (12.5

mg/kg/day) owing to reduction of

female body weight gain and significant

reductions in male pup weight at day

21.

10. A developmental toxicity study in

rabbits with a maternal NOEL of 25 mg/

kg and an LEL of 75 mg/kg/day owing

to decreased body weight, death of one

doe and abortion, and a developmental

NOEL of 25 mg/kg, and an LEL of 75

mg/kg owing to increased

postimplantation loss and resorptions

and significantly decreased fetal weight.

11. A developmental toxicity study in

rats with a maternal NOEL of 16 mg/kg

and an LEL of 85 mg/kg owing to excess

salivation, and decreased body weight

gain and food consumption, and a

developmental NOEL of 85 mg/kg/day,

and an LEL of 171 mg/kg owing to

increase bifid or unilateral ossification

of thoracic vertebrate, increased average

number of ossified hyoid, and decrease

in average number of sternal centers of

ossification.

12. A microbial gene mutation study

and an unscheduled DNA synthesis in

rat hepatocyte study were both negative.

An in vivo micronucleus assay/

chromosomal analysis study showed no

increase in micronucleated

polychromatic erythrocytes at any dose

tested.

13. A rat metabolism study showed

that difenoconazole was adequately

absorbed and mainly eliminated via the

bile. No evidence of bioaccumulation in

any tissue was noted.

The Health Effects Division,

Carcinogenicity Peer Review

Committee, has concluded that the

available data provide limited evidence

of the carcinogenicity of difenoconazole

in mice and has classified

difenoconazole as a Group C (possible

human carcinogen with limited

evidence of carcinogenicity in animals)

in accordance with Agency guidelines,

published in the Federal Register in

1986 (51 FR 33992; Sept. 24, 1986) and

recommended that quantitative risk

assessment is not appropriate for the

following reasons:

1. The carcinogenic response

observed with this chemical,

statistically significant increases in

hepatocellular adenomas, carcinomas,

and combined adenomas/carcinomas in

both sexes of CD-1 mice, occurred only

at doses considered to be excessively

high for carcinogenicity testing.

2. There were no apparent tumor

increases in either sex in SpragueDawley rats at dietary levels up to 2,500

ppm.

3. Difenoconazole was not mutagenic

in three well conducted genotoxic

assays.

Based on this evidence, EPA

concludes that difenoconazole poses at

most a negligible cancer risk to humans

and that for purposes of risk

characterization the Reference Dose

(RfD) and Margin of Exposure (MOE)

approaches should be use for

quantification of human risk. In a spring

wheat processing study, no residues

were detected in grain or any processed

fraction. Therefore, food/feed additive

tolerances are not needed in

conjunction with this use on barley, rye,

and wheat.

Using a 100-fold safety factor and the

NOEL of 1 mg/kg/day determined from

the rat chronic feeding study (the most

sensitive species), the Reference Dose

RfD is 0.01 mg/kg/day. The theoretical

maximum residue contribution (TMRC)

from the established and proposed

tolerances is 0.00042 mg/kg/day and

utilizes 4 percent of the RfD for the

overall U.S. population. For exposure of

the most highly exposed subgroups in

the population, children (ages 1 to 6

years old) and nonnursing infants (less

than 1 year old), the TMRC is 0.000947

mg/kg/day and 0.000960 mg/kg/day and

utilizes 9 and 10 percent of the RfD,

respectively.

The dietary acute exposure MOE for

developmental toxicity effects was

calculated to be 62,500 for high

exposure in the females 13+ subgroup.

For substances whose acute NOEL is

based on animal studies, the Agency is

not generally concerned unless the MOE

is below 100.

The metabolism of difenoconazole in

plants is adequately understood. The

tolerances established for milk, eggs,

meat, fat, and meat byproducts will

cover any dietary exposure from

secondary residues in these RACs.

There are currently no actions pending

against the continued registration of this

chemical.

An adequate analytical method, gas

chromatography with nitrogen

phosphorous detection, is available for

enforcement purposes. Because of the

long lead time from establishing these

tolerances to publication of the

enforcement methodology in the

Pesticide Analytical Manual, Vol. II, the

analytical methodology is being made

available in the interim to anyone

interested in pesticide enforcement

when requested from: Calvin Furlow,

Public Information Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location

and telephone number: Rm. 242, CM #2,

1921 Jefferson Davis Hwy., Arlington,

VA 22202, (703-305-4432).

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 2E4051/P608]. 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
Federal Register / Vol. 60, No. 70 / Wednesday, April 12, 1995 / Proposed Rules 18557

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: March 28, 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. In § 180.475, by adding new

paragraph (c), to read as follows:

§ 180.475 Difenoconazole; tolerances for

residues.

* * * *

*

(c) Tolerances are established for

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 following raw

agricultural commodities:

Commodity Parts per

million

Barley, grain1 ............................ 0.1

Cattle, fat .................................. 0.05

Cattle, meat .............................. 0.05

Cattle, mbyp ............................. 0.05

Eggs .......................................... 0.05

Goats, fat .................................. 0.05

Goats, meat .............................. 0.05

Goats, mbyp ............................. 0.05

Hogs, fat ................................... 0.05

Hogs, mbyp .............................. 0.05

Commodity Parts per

million

Horses, fat ................................ 0.05

Horses, meat ............................ 0.05

Horses, mbyp ........................... 0.05

Milk ........................................... 0.01

Poultry, fat ................................ 0.05

Poultry, meat ............................ 0.05

Poultry, mbyp ............................ 0.05

Rye, grain1 ................................ 0.1

Sheep, fat ................................. 0.05

Sheep, meat ............................. 0.05

Sheep, mbyp ............................ 0.05

Wheat, grain ............................. 0.1

1 There are no U.S. registrations as of April

12, 1995 for use on barley and rye.

[FR Doc. 95–8728 Filed 4–11–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[OPP–300384; FRL–4945–7]

RIN 2070–AC18

Oleyl Alcohol; Tolerance Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This document proposes that

oleyl alcohol (CAS Reg. No. 143-28-2) be

exempted from the requirement of a

tolerance when used as a cosolvent in

pesticide formulations applied to

growing crops or to raw agricultural

commodities after harvest. Henckel

Corp., Emery Group, requested this

proposed regulation.

DATES: Comments, identified by the

document control number [OPP300384], 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,

deliver comments to: Rm. 1132, Crystal

Mall, Building #2, 1921 Jefferson Davis

Hwy., Arlington, VA 22202.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part of 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

will be included in the public docket by

the EPA without prior notice. The

public docket is 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: Amelia M. Acierto, Registration

Support Branch, Registration Division

(7505W), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

2800 Crystal Drive, North Tower,

Arlington, VA 22202, (703)-308-8375; email: Acierto.Amelia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Henkel

Corp., Emery Group, 4900 Este Ave.,

Cincinnati, OH 45232-1491, submitted

pesticide petition (PP) 4E4335 to EPA

requesting that the Administrator,

pursuant to section 408(e) of the Federal

Food, Drug, and Cosmetic Act, 21 U.S.C.

346a(e), propose to amend 40 CFR

180.1001(c) by establishing an

exemption from the requirement of a

tolerance for oleyl alcohol when used as

a cosolvent in pesticide formulations

applied to growing crops and raw

agricultural commodities after harvest.

Inert ingredients are all ingredients

that are not active ingredients as defined

in 40 CFR 153.125, and include, but are

not limited to, the following types of

ingredients (except when they have a

pesticidal efficacy of their own):

solvents such as alcohols and

hydrocarbons; surfactants such as

polyoxyethylene polymers and fatty

acids; carriers such as clay and

diatomaceous earth; thickeners such as

carrageenan and modified cellulose;

wetting, spreading, and dispersing

agents; propellants in aerosol

dispensers; microencapsulating agents;

and emulsifiers. The term ‘‘inert’’ is not

intended to imply nontoxicity; the

ingredient may or may not be

chemically active.

The data submitted in the petition

and other relevant material have been

evaluated. As part of the EPA policy

statement on inert ingredients published

in the Federal Register of April 22, 1987

(52 FR 13305), the Agency established

data requirements which will be used to

evaluate the risks posed by the presence

of an inert ingredient in a pesticide

formulation. Exemptions from some or

all of the requirements may be granted

if it can be determined that the inert

ingredient will present minimal or no

risk. The Agency has decided that the

data normally required to support the

proposed tolerance exemption for oleyl

alcohol will not need to be submitted.

The rationale for this decision is

described below: