[Federal Register Volume 61, Number 245 (Thursday, December 19, 1996)]
[Rules and Regulations]
[Pages 66918-66919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32126]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 96F-0205]


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 additional 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 
and/or stabilizer in propylene homopolymer and high-propylene olefin 
copolymer articles intended for use in contact with food. This action 
is in response to a petition filed by Sumitomo Chemical America, Inc.

DATES: Effective December 19, 1996; written objections and requests for 
a hearing by January 21, 1997.

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: 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 July 3, 1996 (61 FR 34853), FDA announced that a food 
additive petition (FAP 6B4510) had been filed by Sumitomo Chemical 
America, Inc., c/o Keller and Heckman, 1001 G St. NW., suite 500 West, 
Washington, DC 20001. 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 additional 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 intended for use in 
contact with food.
    FDA has evaluated the data in the petition and other relevant 
material. The agency concludes that the proposed use of the additive is 
safe, that the food additive will have the intended technical effect, 
and therefore, 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 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 Sec. 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 January 21, 1997, 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) 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'' by adding a new entry ``3.'' under the 
heading ``Limitations'' to read as follows:


Sec. 178.2010  Antioxidants and/or stabilizers for polymers.

* * * * *
    (b) * * *

[[Page 66919]]



                                                                        
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             Substances                          Limitations            
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  *                    *                    *                    *      
                   *                    *                    *          
3,9-Bis[2-{3-(3-tert-butyl-4-        * * *                              
 hydroxy-5-                          3. At levels not to exceed 0.3     
 methylphenyl)propionyloxy}-1,1-      percent by weight of olefin       
 dimethylethyl]-2,4,8,10-             polymers complying with Sec.      
 tetraoxaspiro[5.5]undecane (CAS      177.1520(c) of this chapter, items
 Reg. No. 90498-90-1).                1.1, 3.1, and 3.2, where the      
                                      copolymers complying with items   
                                      3.1 and 3.2 contain not less than 
                                      85 weight percent of polymer units
                                      derived from propylene. The       
                                      finished polymer is to be used in 
                                      contact with food of types I, II, 
                                      IV-B, VI-A, VI-B, VI-C, VII-B, and
                                      VIII under conditions of use A    
                                      through H described in Tables 1   
                                      and 2 of Sec.  176.170(c) of this 
                                      chapter.                          
  *                    *                    *                    *      
                   *                    *                    *          
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    Dated: December 4, 1996.
Fred R. Shank,
Director, Center for Safety and Applied Nutrition.
[FR Doc. 96-32126 Filed 12-18-96; 8:45 am]
BILLING CODE 4160-01-F