[Federal Register Volume 60, Number 125 (Thursday, June 29, 1995)]
[Rules and Regulations]
[Pages 33711-33712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15922]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 21 CFR Part 178

[Docket No. 93F-0033]


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 3,9-bis[2-{3-(3-
tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy}-1,1-dimethylethyl]-
2,4,8,10-tetraoxaspiro[5.5]undecane as an antioxidant for high density 
polyethylene intended for use in food-contact articles. This action is 
in response to a petition filed by Sumitomo Chemical America, Inc.

DATES: Effective June 29, 1995; written objections by July 31, 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: Hortense S. Macon, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3086.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of March 12, 1993 (58 FR 13604), FDA announced that a food 
additive petition (FAP 3B4358) 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 Sec. 178.2010 Antioxidants 
and/or stabilizers for polymers (21 CFR 178.2010) to provide for the 
safe use of 3,9-bis[2-{3-(3-tert-butyl-4-hydroxy-5-
methylphenyl)propionyloxy}-1,1-dimethylethyl]-2,4,8,10-
tetraoxaspiro[5.5]undecane as an antioxidant for polyethylene complying 
with Sec. 177.1520 Olefin polymers (21 CFR 177.1520) intended for use 
in food-contact articles.
     FDA has evaluated the data in the petition and other relevant 
material. The agency concludes that data in the petition support the 
safe use of the additive only in high density polyethylene with a 
minimum density of 0.94, and under limited use conditions. Therefore, 
the use of the additive has been limited in Sec. 178.2010(b) consistent 
with these conditions.
    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 31, 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 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 
revising the ``Limitations'' for the entry ``3,9-Bis[2-{3-(3-tert-
butyl-4-hydroxy-5-methylphenyl)propionyloxy}-1,1 dimethylethyl]-
2,4,8,10-tetraoxaspiro[5.5]undecane'' to read as follows:


Sec. 178.2010  Antioxidants and/or stabilizers for polymers.

 * * * * *
     (b) *  *  *

                                                                        

[[Page 33712]]
                                                                        
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           Substances                          Limitations              
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  *                    *                    *                    *      
                   *                    *                    *          
 3,9-Bis[2-{3-(3-tert-butyl-4-  For use only:                           
 hydroxy-5-                                                             
 methylphenyl)propionyloxy}-                                            
 1,1-dimethylethyl]-2,4,8,10-                                           
 tetraoxaspiro[5.5]undecane                                             
 (CAS Reg. No. 90498-90-1).                                             
                                 1. At levels not to exceed 0.2 percent 
                                 by weight of polypropylene complying   
                                 with Sec.  177.1520(c), item 1.1 of    
                                 this chapter. The finished polymer is  
                                 to be used in contact with food only   
                                 under conditions of use D through H    
                                 described in Table 2 of Sec.           
                                 176.170(c) of this chapter.            
                                 2. At levels not to exceed 0.3 percent 
                                 by weight of polyethylene complying    
                                 with Sec.  177.1520(c) of this chapter,
                                 item 2.1, provided that the polymer has
                                 a minimum density of 0.94 grams per    
                                 cubic centimeter and is used in contact
                                 with food only under conditions of use 
                                 D through G described in Table 2 of    
                                 Sec.  176.170(c) of this chapter.      
  *                    *                    *                    *      
                   *                    *                    *          
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    Dated: June 15, 1995.

Janice F. Oliver,

Deputy Director for Systems and Support, Center for Food Safety and 
Applied Nutrition.

[FR Doc. 95-15922 Filed 6-28-95; 8:45 am]
BILLING CODE 4160-01-F