[Federal Register Volume 61, Number 172 (Wednesday, September 4, 1996)]
[Rules and Regulations]
[Pages 46544-46545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22483]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178

[Docket No. 96F-0092]


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 expanded safe use of 
phosphorous acid, cyclic neopentanetetrayl bis(2,6-di-tert-butyl-4-
methylphenyl)ester for use as an antioxidant and/or stabilizer at 
levels not to exceed 0.05 percent by weight of olefin polymers intended 
for use in contact with food. This action is in response to a petition 
filed by Asahi Denka Kogyo K. K.

DATES: Effective September 4, 1996; written objections and requests for 
a hearing by October 4, 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: 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 25, 1996 (61 FR 12075), FDA announced that a food 
additive petition (FAP 6B4498) had been filed by Asahi Denka Kogyo K. 
K., 2-13 Shirahata 5-Chome, Urawa City, Saitama 336, Japan. 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 expanded safe use of phosphorous acid, 
cyclic neopentanetetrayl bis(2,6-di-tert-butyl-4-methylphenyl)ester for 
use as an antioxidant and/or stabilizer at levels not to exceed 0.05 
percent by weight of olefins complying with 21 CFR 177.1520 intended 
for use in contact with food.
    FDA has evaluated data in the petition and other relevant material.

[[Page 46545]]

Based on this information, the agency concludes that the proposed use 
of the additive is safe, that the additive will achieve its 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 October 4, 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 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 entry for ``Phosphorous acid, cyclic neopentanetetrayl 
bis(2,6-di-tert-butyl-4-methylphenyl)ester'' under the heading 
``Substances'' and by adding a new entry ``2.'' under the heading 
``Limitations'' to read as follows:


Sec. 178.2010  Antioxidants and/or stabilizers for polymers.

* * * * *
    (b) * * *

                                                                                                                
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                       Substances                                               Limitations                     
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
Phosphorous acid, cyclic neopentanetetrayl bis(2,6-di-                                                          
 tert-butyl-4-methylphenyl)ester (CAS Reg. No. 80693-00-                                                        
 1).....................................................  For use only:                                         
  ......................................................  1. At levels not to exceed 0.25 percent by weight of  
                                                           polypropylene complying with Sec.  177.1520 of this  
                                                           chapter. * * *                                       
  ......................................................  2. At levels not to exceed 0.05 percent by weight of  
                                                           polymers complying with Sec.  177.1520(c) of this    
                                                           chapter, item 3.1 or 3.2, and with a maximum         
                                                           thickness of 100 micrometers (0.004 inch) for use    
                                                           with all food types under conditions of use B, C, D, 
                                                           E, F, G, and H described in Table 2 of Sec.          
                                                           176.170(c) of this chapter.                          
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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    Dated: August 20, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-22483 Filed 9-3-96; 8:45 am]
BILLING CODE 4160-01-F