[Federal Register Volume 59, Number 37 (Thursday, February 24, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4079]


[[Page Unknown]]

[Federal Register: February 24, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178

[Docket No. 93F-0180]

 

Indirect Food Additives: Adjuvants, Production Aids, and 
Sanitizers

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 2,4-di-tert-pentyl-
6-[1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl]phenyl acrylate as an 
antioxidant in the manufacture of polypropylene and styrene block 
polymers that contact food. This action is in response to two petitions 
filed by Sumitomo Chemical America, Inc.

DATES: Effective February 24, 1994; written objections and requests for 
a hearing by March 28, 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 Anand, Center for Food Safety and 
Applied Nutrition (HFS-216), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, 202-254-9500.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of June 23, 1993 (58 FR 34058), FDA announced that two food 
additive petitions (FAP's 3B4357 and 3B4359) had been filed by Sumitomo 
Chemical America, Inc., 345 Park Ave., New York, NY 10154, proposing 
that food additive regulations be amended in Sec. 178.2010 Antioxidants 
and/or stabilizers for polymers (21 CFR 178.2010) to provide for the 
safe use of 2,4-di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2-
hydroxyphenyl)ethyl]phenyl acrylate as an antioxidant in the 
manufacture of polypropylene and styrene block polymers that contact 
food.
    FDA has evaluated data in the petitions and other relevant 
material. The agency concludes that the proposed uses of the additive 
are safe and that the regulations in Sec. 178.2010 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 petitions 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 March 28, 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 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) by 
alphabetically adding a new entry under the headings ``Substances'' and 
``Limitations'' to read as follows:


Sec.  178.2010   Antioxidants and/or stabilizers for polymers.

* * * * *
     (b) *  *  *

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             Substances                          Limitations            
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                                 *******                                
2,4-Di-tert-pentyl-6-[1-(3,5-di-     For use only:                      
 tert-pentyl-2-                                                         
 hydroxyphenyl)ethyl]phenyl                                             
 acrylate (CAS Reg. No. 123968-25-                                      
 2).                                                                    
                                     1. At levels not to exceed 0.2     
                                      percent by weight of polypropylene
                                      complying with Sec. 177.1520 of   
                                      this chapter. The additive is used
                                      under conditions of useD through G
                                      described in Table 2 of Sec.      
                                      176.170(c) of this chapter.       
                                     2. At levels not to exceed 0.5     
                                      percent by weight of styrene block
                                      polymers complying with Sec.      
                                      177.1810 of this chapter. The     
                                      additive is used under conditions 
                                      of use D through G described in   
                                      Table 2 of Sec. 176.170(c) of this
                                      chapter.                          
                                 *******                                
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    Dated: February 15, 1994.
Janice F. Oliver,
Acting Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-4079 Filed 2-23-94; 8:45 am]
BILLING CODE 4160-01-F