28118 Federal Register / Vol. 61, No. 108 / Tuesday, June 4, 1996 / Proposed Rules

This ANPRM is issued under section

301 et seq. of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 301 et seq.)

and under the authority of the

Commissioner of Food and Drugs.

Dated: May 28, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96–13980 Filed 6–3–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[INTL–0054–95]

RIN 1545–AT96

Proposed Amendments to the

Regulations on the Determination of

Interest Expense Deduction of Foreign

Corporations and Branch Profits Tax;

Correction

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Correction to notice of proposed

rulemaking.

SUMMARY: This document contains a

correction to the notice of proposed

rulemaking [INTL–0054–95] which was

published in the Federal Register for

Friday, March 8, 1996 (61 FR 9377). The

notice of proposed rulemaking relate to

the determination of the interest

expense deduction of foreign

corporations, and the branch profits tax.

FOR FURTHER INFORMATION CONTACT:

Ahmad Pirasteh or Richard Hoge (202)

622–3870 (not a toll-free number).

SUPPLEMENTARY INFORMATION:

Background

The notice of proposed rulemaking

that is subject to these corrections are

under sections 882 and 884 of the

Internal Revenue Code.

Need for Correction

As published, the proposed

rulemaking contains errors that are in

need of clarification.

Correction of Publication

Accordingly, the publication of the

proposed rulemaking which is the

subject of FR Doc. 96–5264 is corrected

as follows:

1. On page 9378, in the preamble

under column 2, following the

paragraph heading ‘‘B. Hedging

transactions’’, line 6, the language ‘‘case

may be, the amount of their U.S.’’ is

corrected to read ‘‘case may be, the

amount of its U.S.’’.

§ 1.882–5 [Corrected]

2. On page 9379, column 3, § 1.882–

5(d)(6), Example 4. (i), line 18, the

language ‘‘liabilities of 90x U.S. dollars

and 1000 x’’ is corrected to read

‘‘liabilities of 90x U.S. dollars and

1000x’’.

§ 1.884–1 [Corrected]

3. On page 9380, column 3, § 1.884–

1(d)(2)(xi), Example 8., last line, the

language ‘‘from securities) of the value

of the securities.’’ is corrected to read

‘‘from securities) of the amount of the

securities.’’.

Cynthia E. Grigsby,

Chief, Regulations Unit, Assistant Chief

Counsel (Corporate).

[FR Doc. 96–13722 Filed 6–3–96; 8:45 am]

BILLING CODE 4830–01–U

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[PP 5E04443/P659; FRL–5371–5]

RIN 2070–AB18

1,1-Difluoroethane; Proposed

Exemption from Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This document proposes that

residues of 1,1-difluoroethane (CAS Reg.

No. 75–37–6) be exempted from the

requirement of a tolerance when used as

an inert ingredient (aerosol propellant)

in aerosol pesticide formulations used

for insect control in food- and feedhandling establishments and animals.

This proposed regulation was requested

by The Dupont Company, pursuant to

the Federal Food, Drug, and Cosmetic

Act (FFDCA).

DATES: Comments, identified by the

docket control number [PP 5E04443/

P659], must be received on or before

July 5, 1996.

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 #2, 1921 Jefferson Davis Highway,

Arlington, VA.

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

will be included in the public docket by

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 4:30 p.m., Monday

through Friday, excluding legal

holidays.

Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect in 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket

number, [PP 5E04443/P659]. No CBI

should be submitted through e-mail.

Electronic comments on this proposed

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: 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, telephone number, and

e-mail address: 2800 Crystal Drive,

North Tower, Arlington, VA, (703) 308–

8375, e-mail:

acierto.amelia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: The

Dupont Company, 1007 Market Street,

Wilmington, DE 19898 has submitted

pesticide petition (PP) 5E04443 to EPA

requesting that the Administrator,

pursuant to section 408(e) of the

FFDCA, 21 U.S.C. 346a(e), propose to

amend 40 CFR 180.1001(c) and (e) by

establishing an exemption from the

requirement of a tolerance for the

residues of 1,1-difluoroethane (CAS Reg.

No. 75–37–6) when used as an inert

ingredient (aerosol propellant) in

aerosol pesticide formulations used for

insect control in food- and feedhandling establishments and animals.

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
Federal Register / Vol. 61, No. 108 / Tuesday, June 4, 1996 / Proposed Rules 28119

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 set forth a list

of studies which would generally be

used to evaluate the risks posed by the

presence of an inert ingredient in a

pesticide formulation. However, where

it can be determined without that data

that the inert ingredient will present

minimal or no risk, the Agency

generally does not require some or all of

the listed studies to rule on the

proposed tolerance or exemption from

the requirement of a tolerance for an

inert ingredient. The Agency has

decided that no data, in addition to that

described below, for 1,1-difluoroethane

will need to be submitted. The rationale

for this decision is described below:

1. 1,1-Difluoroethane has been

designated by the EPA as a substance

about which it has little concern

regarding its ozone-depleting potential

and is listed as an acceptable substitute

for certain uses of currently used ozonedepleting propellants. 1,1-

Difluoroethane is now used in consumer

products (e.g., hair sprays, baby oil

mousse, spray bandage, rug shampoos

and oven cleaners).

2. An acute rat toxicity study which

showed no mortality when animals

were exposed to 1,1-difluoroethane at

concentrations up to 200,000 ppm,

indicating that the substance is

essentially non-toxic following acute

inhalation exposure.

3. A chronic rat inhalation toxicity

study with exposures for 6 hours, 5

days/week for 2 years, with a noobserved-effect-level (NOEL) of 27,000

mg/M3 and LOEL of 67,500 mg/M3

based on mild reversible renal effects.

4. A rat inhalation developmental

toxicity study with pregnant CD rats

exposed to concentrations of 0, 5,000 or

50,000 ppm for 6 hours/day on gestation

days 6 through 15 showing no

treatment-related maternal or fetal

effects at any dose level, indicating that

1,1-difluoroethane is not a

developmental toxicant at dose levels of

equal or less than 50,000 ppm.

5. A human (volunteers) study

reported no adverse effects except for

reversible analgesia and feelings of

impending loss of consciousness after

acute inhalation exposure to 500,000

ppm of 1,1-difluoroethane.

6. 1,1-Difluoroethane is approved

under 21 CFR 178.3010 by the United

States Food and Drug Administration

(FDA) as an indirect food additive (e.g.,

blowing agent in the production of

polystyrene articles which come in

contact with food).

7. 1,1-Difluoroethane is a gas at

ambient temperatures. Therefore, rapid

volatilization of the substance and

dilution by ambient air is expected,

suggesting that human exposure would

be insignificant. It would not be

expected that the Reference Dose (RfD)

of 74 ppm (200 mg/M3) established by

the Agency for this chemical would be

reached or exceeded in exposures

resulting from its intended use as an

aerosol propellant.

The toxicological profile indicates a

lack of chronic, subchronic or

developmental toxicity. Based upon the

physico-chemical characteristics, and

review of its use, and the determination

that there is no reasonable expectation

of finite residues in food or feed items

as a result of its use as a propellent in

pesticide formulations, the Agency has

concluded that the use of 1,1-

difluoroethane would result in

negligible risks to human health and the

environment. Accordingly, the Agency

has found that, 1,1-difluoroethane,

when used in accordance with good

agricultural practice, is useful and a

tolerance is not necessary to protect the

public health. Therefore, EPA proposes

that the exemption from the

requirement of a 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 proposal be

referred to an Advisory Committee in

accordance with section 408(e) of

FFDCA.

Interested persons are invited to

submit written comments on the

proposed regulation. Comments must

bear a notation indicating the docket

control number, [PP 5E04443/P659]. 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 4:30 p.m. Monday through

Friday, except legal holidays.

A record has been established for this

rulemaking under docket number [PP

5E04443/P659] (including 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 Mallι2, 1921

Jefferson Davis Highway, Arlington, VA.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments 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 all comments 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.

The Office of Management and Budget

has exempted this proposed rule from

the requirements of section 3 of

Executive Order 12866.

This action does not impose any

enforceable duty, or contain any

‘‘unfunded mandates’’ as described in

Title II of the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104–4), or

require prior consultation as specified

by Executive Order 12875 (58 FR 58093,

October 28, 1993), entitled Enhancing

the Intergovernmental Partnership, or

special consideration as required by

Executive Order 12898 (59 FR 7629,

February 16, 1994).

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96–

3 54, 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).
28120 Federal Register / Vol. 61, No. 108 / Tuesday, June 4, 1996 / Proposed Rules

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 15, 1991.

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. Section 180.1001 is amended in

paragraphs (c) and (e) in the table

therein by adding and alphabetically

inserting the inert ingredient, to read as

follows:

§ 180.1001 Exemptions from the

requirements of a tolerance.

* * * * *

(c) * * *

Inert Ingredients Limits Uses

* * * * * * *

1,1-difluoroethane (CAS Reg. No. 75–37–6) ................ For aerosol pesticide formulations used for insect control

in food- and feed-handling

establishments and animals.

Aerosol propellant

* * * * * * *

* * * * * (e) * * *

Inert Ingredients Limits Uses

* * * * * * *

1,1-difluoroethane (CAS Reg. No. 75–37–6) ................ For aerosol pesticide formulations used for insect control

in food- and feed-handling

establishments and animals

Aerosol propellant

* * * * * * *

[FR Doc. 96–13440 Filed 6–3–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 6E04704/P657; FRL–5369–5]

RIN 2070–AC18

α-Alkyl (C10-C15)-ω-Hydroxy

Poly(oxyethylene) Sulfate and its

Ammonium, Calcium, Magnesium,

Potassium, Sodium and Zinc Salts;

Tolerance Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This document proposes that

the current exemption from the

requirement of a tolerance for α-alkyl

(C12-C15)-ω-hydroxy poly(oxyethylene)

sulfate and its ammonium, calcium,

magnesium, potassium, sodium and

zinc salts; the polyoxyethylene content

averages 3 moles be amended to include

alkyl groups ranging from C10-C14. This

proposed regulation was requested by

Henkel Corporation pursuant to Federal

Food, Drug, and Cosmetic Act (FFDCA).

DATES: Comments, identified by the

docket control number [PP 6E04704/

P657], must be received on or before

July 5, 1996.

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 #2, 1921 Jefferson Davis Highway,

Arlington, VA.

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

will be included in the public docket by

EPA without prior notice. The public

docket is available for public inspection

in Rm. 1132 at the Virginia address

given above, from 8 a.m. to 4:30 p.m.,

Monday through Friday, excluding legal

holidays.

Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket

number, [PP 6E04704/P657]. No CBI

should be submitted through e-mail.

Electronic comments on this proposed

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: Bipin Gandhi, Registration

Support Branch, Registration Division

(7505W), Office of Pesticide Programs,