[Federal Register Volume 61, Number 113 (Tuesday, June 11, 1996)]
[Rules and Regulations]
[Page 29474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14648]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. 88F-0426]


Indirect Food Additives: Adhesives and Components of Coatings

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 3-aminomethyl-
3,5,5-trimethylcyclohexylamine as a cross-linking agent for use in 
epoxy resin coatings. This action responds to a petition filed by Huels 
AG.

DATES: Effective June 11, 1996; written objections and requests for a 
hearing by July 11, 1996.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Julius Smith, Center for Food Safety 
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3091.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of January 26, 1989 (54 FR 3853), FDA announced that a food 
additive petition (FAP 9B4118) had been filed by Huels AG, P.O. Box 
1320, D-4370 Marl, Federal Republic of Germany (currently c/o Bruce 
EnvivoExcel Group, Inc., 94 Buttermilk Bridge Rd., Washington, NJ 
07882). The petition proposed that the food additive regulations in 
Sec. 175.300 Resinous and polymeric coatings (21 CFR 175.300) be 
amended to provide for the safe use of 3-aminomethyl-3,5,5-
trimethylcyclohexylamine as a cross-linking agent for use in epoxy 
resins complying with Sec. 175.300(b)(3)(viii).
    FDA has evaluated the data in the petition and other relevant 
material. The agency concludes that the proposed use of the additive in 
resinous and polymeric coatings that are intended for contact with 
foods is safe and that the regulations in Sec. 175.300 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 July 11, 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 175

    Adhesives, 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 175 is amended as follows:

PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF 
COATINGS

    1. The authority citation for 21 CFR part 175 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 175.300 is amended in paragraph (b)(3)(viii)(b) by 
alphabetically adding a new entry to read as follows:


Sec. 175.300  Resinous and polymeric coatings.

* * * * *
    (b) * * *
    (3) * * *
    (viii) * * *
    (b) Catalysts and cross-linking agents for epoxy resins:
3-Aminomethyl-3,5,5-trimethylcyclohexylamine (CAS Reg. No. 2855-13-2).
* * * * *

    Dated: May 12, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-14648 Filed 6-10-96; 8:45 am]
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