[Federal Register Volume 59, Number 164 (Thursday, August 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20982]


[[Page Unknown]]

[Federal Register: August 25, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 177

[Docket No. 94N-0014]

 

 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 p-cumylphenol as a 
chain terminator in the manufacture of polycarbonate resins intended 
for use in food-contact applications. This action is in response to a 
petition filed by General Electric Co.

DATES: Effective August 25, 1994; written objections and requests for a 
hearing by September 26, 1994.

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 March 29, 1994 (59 FR 14626), FDA announced that a food 
additive petition (FAP 4B4413) had been filed by General Electric Co., 
1 Lexan Lane, Mt. Vernon, IN 47620-9364. The petition proposed to amend 
the food additive regulations in Sec. 177.1580 Polycarbonate resins (21 
CFR 177.1580) to provide for the safe use of p-cumylphenol as a chain 
terminator in the manufacture of polycarbonate resins intended for use 
in food-contact applications.
     FDA has evaluated data in the petition and other relevant 
material. The agency concludes that the proposed use of the additive is 
safe and that Sec. 177.1580(b) 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 September 26, 1994, 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 177.1580 is amended in paragraph (b) by alphabetically 
adding a new entry under the headings ``List of Substances'' and 
``Limitations'' to read as follows:


Sec. 177.1580  Polycarbonate resins.

 * * * * *
     (b) * * * 

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         List of Substances                       Limitations           
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                                  *****                                 
 p-Cumylphenol (CAS Reg. No. 599-64-  For use only as a chain terminator
 4).                                   at a level not to exceed 5       
                                       percent by weight of the resin.  
                                  *****                                 
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 * * * * *

    Dated: August 16, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-20982 Filed 8-24-94; 8:45 am]
BILLING CODE 4160-01-F