Federal Register / Vol. 60, No. 87 / Friday, May 5, 1995 / Rules and Regulations 22269

By authority of the Board.

For the Board,

Beatrice Ezerski,

Secretary to the Board.

[FR Doc. 95–11142 Filed 5–4–95; 8:45 am]

BILLING CODE 7905–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 94F–0440]

Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the safe use of 2,2′-methylenebis(4-

methyl-6-tert-butylphenol)monoacrylate

as an antioxidant in acrylonitrilebutadiene-styrene copolymers intended

for use in contact with food. This action

is in response to a petition filed by

Sumitomo Chemical America, Inc.

DATES: Effective May 5, 1995; written

objections and requests for a hearing by

June 5, 1995.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–216), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

January 3, 1995 (60 FR 129), FDA

announced that a food additive petition

(FAP 5B4443) had been filed by

Sumitomo Chemical America, Inc., 345

Park Ave., New York, NY 10154. The

petition proposed to amend the food

additive regulations in § 178.2010

Antioxidants and/or stabilizers for

polymers (21 CFR 178.2010) to provide

for the safe use of 2,2′-methylenebis(4-

methyl-6-tert-butylphenol)monoacrylate

as an antioxidant in acrylonitrilebutadiene-styrene copolymers

complying with § 177.1020 (21 CFR

177.1020) intended for use in contact

with food.

FDA has evaluated data in the

petition and other relevant material. The

agency concludes that the proposed

food additive use is safe, and that the

regulations in § 178.2010 should be

amended as set forth below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in 21 CFR

171.1(h), the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

Any person who will be adversely

affected by this regulation may at any

time on or before June 5, 1995, file with

the Dockets Management Branch

(address above) written objections

thereto. Each objection shall be

separately numbered, and each

numbered objection shall specify with

particularity the provisions of the

regulation to which objection is made

and the grounds for the objection. Each

numbered objection on which a hearing

is requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objection received in

response to the regulation may be seen

in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

List of Subjects in 21 CFR Part 178

Food additives, Food packaging.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Director, Center for Food Safety and

Applied Nutrition, 21 CFR part 178 is

amended as follows:

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR

part 178 continues to read as follows:

Authority: Secs. 201, 402, 409, 721 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348, 379e).

2. Section 178.2010 is amended in the

table in paragraph (b) for the entry ‘‘2,2′-

methylenebis(4-methyl-6-tertbutylphenol)monoacrylate’’ by adding a

new entry ‘‘4.’’ under the heading

‘‘Limitations’’ to read as follows:

§ 178.2010 Antioxidants and/or stabilizers

for polymers.

* * * * *

(b) * * *

Substances Limitations

* * * * *

2,2′-Methylenebis(4-

methyl-6-tertbutylphenol)monoacrylate

(CAS Reg. No.

61167–58–6).

For use only:

* * * * *

4. At levels not to

exceed 0.5 percent

by weight of acrylonitrile-butadienestyrene copolymers

that comply with

§ 177.1020 of this

chapter when used

in articles that contact food only

under conditions of

use E, F, and G as

described in Table

2, § 176.170 (c) of

this chapter.

* * * * *

Dated: April 24, 1995.

Fred R. Shank,

Director, Center for Food Safety and Applied

Nutrition.

[FR Doc. 95–11060 Filed 5–4–95; 8:45 am]

BILLING CODE 4160–01–F

NATIONAL LABOR RELATIONS

BOARD

29 CFR Part 100

Administrative Regulations

AGENCY: National Labor Relations Board

(NLRB).