[Federal Register Volume 61, Number 172 (Wednesday, September 4, 1996)]
[Rules and Regulations]
[Pages 46545-46547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22484]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178

[Docket No. 96F-0027]


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 bis(2,4-di-tert-
butyl-6-methylphenyl) ethyl phosphite as a processing stabilizer for 
olefin polymers intended for use in contact with food. This action is 
in response to a petition filed by Ciba-Geigy Corp.

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

[[Page 46546]]

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 February 9, 1996 (61 FR 5001), FDA announced that a food 
additive petition (FAP 6B4492) had been filed by Ciba-Geigy Corp., 540 
White Plains Rd., Tarrytown, NY 10591-9005, 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 bis(2,4-di-tert-butyl-6-methylphenyl) ethyl phosphite as a 
processing stabilizer for olefin polymers complying with 21 CFR 
177.1520 intended for use in contact with food.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that the proposed use of the additive is safe, 
that the additive will achieve its intended technical effect, and that 
the regulations in Sec. 178.2010(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 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 
alphabetically adding a new entry for bis(2,4-di-tert-butyl-6-
methylphenyl) ethyl phosphite to read as follows:

Sec. 178.2010  Antioxidants and/or stabilizers for polymers

* * * * *
(b) * * *

                                                                        
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           List of Substances                      Limitations          
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  *                    *                    *                    *      
                   *                    *                    *          
Bis(2,4-di-tert-butyl-6-methylphenyl)    For use only:                  
 ethyl phosphite (CAS Reg. No. 145650-   1. At levels not to exceed 0.3 
 60-8).                                   percent by weight of olefin   
                                          polymers complying with Sec.  
                                          177.1520(c) of this chapter.  
                                          The finished polymers may only
                                          be used with food of the types
                                          identified in Sec.  176.170(c)
                                          of this chapter, Table 1,     
                                          under Categories I, II, IV-B, 
                                          VI-A, VI-B, VII-B, and VIII,  
                                          and under conditions of use B 
                                          through H described in Table 2
                                          of Sec.  176.170(c) of this   
                                          chapter.                      
                                         2. At levels not to exceed 0.1 
                                          percent by weight of propylene
                                          polymers complying with Sec.  
                                          177.1520(c) of this chapter,  
                                          items 1.1, 1.2, 1.3, 3.2b,    
                                          3.4, or 3.5, or 3.1a (where   
                                          the density of this polymer is
                                          at least 0.85 gram per cubic  
                                          centimeter and less than 0.91 
                                          gram per cubic centimeter).   
                                          The finished polymers may only
                                          be used in contact with food  
                                          of the types identified in    
                                          Sec.  176.170(c) of this      
                                          chapter, Table 1, under       
                                          Categories III, IV-A, V, VI-C,
                                          VII-A, and IX, and under      
                                          conditions of use B through H 
                                          described in Table 2 of Sec.  
                                          176.170(c) of this chapter.   

[[Page 46547]]

                                                                        
                                         3. At levels not to exceed 0.1 
                                          percent by weight of high-    
                                          density ethylene polymers     
                                          complying with Sec.           
                                          177.1520(c) of this chapter,  
                                          items 2.1, 2.2, 2.3, 3.1a,    
                                          3.1b, 3.2a, or 3.6 (where the 
                                          density of each of these      
                                          polymers is at least 0.94 gram
                                          per cubic centimeter), or 5.  
                                          The finished polymers may only
                                          be used in contact with food  
                                          of the types identified in    
                                          Sec.  176.170(c) of this      
                                          chapter, Table 1, under       
                                          Categories III, IV-A, V, VI-C,
                                          VII-A, and IX, and under      
                                          conditions of use C (maximum  
                                          temperature 70 C) through G   
                                          described in Table 2 of Sec.  
                                          176.170(c) of this chapter.   
                                          Provided, that the finished   
                                          food contact articles have a  
                                          volume of at least 18.9 liters
                                          (5 gallons).                  
                                         4. At levels not to exceed 0.01
                                          percent by weight of low-     
                                          density ethylene polymers     
                                          complying with Sec.           
                                          177.1520(c) of this chapter,  
                                          items 2.1, 2.2, 2.3, 3.1a,    
                                          3.1b, 3.2a, 3.4, 3.5, or 3.6  
                                          (where the density of each of 
                                          these polymers is less than   
                                          0.94 gram per cubic           
                                          centimeter). The finished     
                                          polymers may only be used in  
                                          contact with food of the types
                                          identified in Sec.  176.170(c)
                                          of this chapter, Table 1,     
                                          under Categories III, IV-A, V,
                                          VI-C, VII-A, and IX, and under
                                          conditions of use B through H 
                                          described in Table 2 of Sec.  
                                          176.170(c) of this chapter.   
                                          Provided, that the average    
                                          thickness of such polymers in 
                                          the form in which they contact
                                          food shall not exceed 0.001   
                                          inch.                         
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

* * * * *

    Dated: August 22, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-22484 Filed 9-3-96; 8:45 am]
BILLING CODE 4160-01-F