[Federal Register Volume 61, Number 172 (Wednesday, September 4, 1996)]
[Rules and Regulations]
[Pages 46543-46544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22482]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 95F-0402]


Indirect Food Additives: Polymers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of di(4-methylbenzoyl) 
peroxide as an accelerator for silicone polymers and elastomers for use 
in contact with food. This action is in response to a petition filed by 
Registration and Consulting Co., Ltd., on behalf of Peroxid-Chemie 
GmbH.

DATES: Effective September 4, 1996; written objections and requests for 
a hearing by October 4, 1996.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-

[[Page 46544]]

305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
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 December 20, 1995 (60 FR 65658), FDA announced that a food 
additive petition (FAP 6B4489) had been filed by Registration and 
Consulting Co., Ltd., on behalf of Peroxid-Chemie GmbH, c/o Bruce A. 
Schwemmer, Bruce EnviroExcel Group, Inc., 94 Buttermilk Bridge Rd., 
Washington, NJ 07882 (formerly 55 River Dr. South No. 1808, Jersey 
City, NJ 07310). The petition proposed to amend the food additive 
regulations in Sec. 177.2600 Rubber articles intended for repeated use 
(21 CFR 177.2600) to provide for the safe use of di(4-methylbenzoyl) 
peroxide as an accelerator for silicone polymers and elastomers 
complying with Sec. 177.2600 for use in contact with food.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that the proposed use of the additive is safe, 
that it will achieve its intended technical effect, and that the 
regulations in Sec. 177.2600 should be amended as set forth below.
    In accordance with Sec. 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 October 4, 1996, 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 objections 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 177

    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 177 is amended as follows:

PART 177--INDIRECT FOOD ADDITIVES: POLYMERS

    1. The authority citation for 21 CFR part 177 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 177.2600 is amended in paragraph (c)(4)(ii)(b) by 
alphabetically adding a new entry for ``Di(4-methylbenzoyl) peroxide'' 
to read as follows:


Sec. 177.2600  Rubber articles intended for repeated use.

      *      *      *      *      *
    (c) * * *
    (4) * * *
    (ii) * * *
    (b) * * *
Di(4-methylbenzoyl) peroxide (CAS Reg. No. 895-85-2) for use only as a 
crosslinking agent in silicone polymers and elastomers identified under 
paragraph (c)(4)(i) of this section at levels not to exceed 1 percent 
by weight of such polymers and elastomers where the total of all 
accelerators does not exceed 1.5 percent by weight of rubber product.
      *      *      *      *      *

    Dated: August 22, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-22482 Filed 9-3-96; 8:45 am]
BILLING CODE 4160-01-F