[Federal Register Volume 62, Number 10 (Wednesday, January 15, 1997)]
[Rules and Regulations]
[Pages 2014-2016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-946]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178

[Docket No. 93F-0309]


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 di-tert-
butylphenyl phosphonite condensation product with biphenyl as an

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antioxidant/stabilizer for olefin polymers and for rubber articles 
intended for repeated use in contact with food. This action is in 
response to a petition filed by Sandoz AG (currently, Clariant Huningue 
S.A.).

DATES: Effective January15, 1997; written objections and requests for a 
hearing by February 14, 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 October 7, 1993 (58 FR 52315), FDA announced that a food 
additive petition (FAP 3B4395) had been filed by Sandoz AG (currently, 
Clariant Huningue S.A.), c/o Registration and Consulting Co., Ltd., CH-
4452 Itingen/Basel, Switzerland. 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 di-tert-butylphenyl phosphonite condensation product with 
biphenyl as an antioxidant/stabilizer for olefin polymers and for 
rubber articles intended for repeated use in contact with food.
    Based on more precise analytical data on the isomeric composition 
of the antioxidant, the petitioner has obtained a new CAS Reg. No. for 
the subject additive. This final rule, therefore, uses the new, 
corrected, CAS Reg. No., 119345-01-6.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that: (1) The proposed use of the additive is 
safe, (2) the food additive will have the intended technical effect, 
and (3) 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 February 14, 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) by 
revising the entry for ``Di-tert-butylphenyl phosphonite condensation 
product with biphenyl * * *'' under the heading ``Substances'' and by 
revising entries ``1.'' and ``4.'' and adding a new entry ``5.'' under 
the heading ``Limitations'' to read as follows:


Sec. 178.2010  Antioxidants and/or stabilizers for polymers.

* * * * *

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                            Substances                                              Limitations                 
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                                          *      *      *      *      *                                         
Di-tert-butylphenyl phosphonite condensation product with          For use only:                                
 biphenyl (CAS Reg. No. 119345-01-6) produced by the condensation  1. At levels not to exceed 0.1 percent by    
 of 2,4-di-tert-butylphenol with the Friedel-Crafts addition        weight of olefin polymers complying with    
 product (phosphorus trichloride and biphenyl) so that the food     Sec.  177.1520(c) of this chapter, items    
 additive has a minimum phosphorus content of 5.4 percent, an       1.1, 1.2, 1.3, 3.2b, 3.3a, 3.3b, 3.4, 3.5,  
 acid value not exceeding 10 mg KOH/gm, and a melting range of 85   and 3.1a (where the density is not less than
 C to 110 C (185 F to 230 F).                                       0.85 gram per cubic centimeter and not more 
                                                                    than 0.91 gram per cubic centimeter); and   
                                                                    2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, and 3.6    
                                                                    (where the density is not less than 0.94    
                                                                    gram per cubic centimeter) and 5.           
                                                                   * * * * *                                    
                                                                   4. At levels not to exceed 0.15 percent by   
                                                                    weight of olefin 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,  
                                                                    and 3.6 (where the polyethylene component   
                                                                    has a density less than 0.94 gram per cubic 
                                                                    centimeter).                                
                                                                   5. At levels not to exceed 0.1 percent by    
                                                                    weight of repeated use rubber articles      
                                                                    complying with Sec.  177.2600 of this       
                                                                    chapter.                                    
                                          *      *      *      *      *                                         
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    Dated: December 19, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 97-946 Filed 1-14-97; 8:45 am]
BILLING CODE 4160-01-F