[Federal Register Volume 60, Number 186 (Tuesday, September 26, 1995)]
[Rules and Regulations]
[Pages 49506-49507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23776]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 94F-0005]


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 oxidized 
bis(hydrogenated tallow alkyl)amines as a process stabilizer for 
polypropylene intended for use in contact with food. This action is in 
response to a petition filed by Ciba-Geigy Corp.

DATES: Effective September 26, 1995; written objections and requests 
for a hearing by October 26, 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: Daniel N. Harrison, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3080.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of February 24, 1994 (59 FR 8995), FDA announced that a food 
additive petition (FAP 4B4410) had been filed by Ciba-Geigy Corp., 
Seven Skyline Dr., Hawthorne, NY 10532. The petition proposed that the 
food additive regulations in Sec. 178.2010 Antioxidants and/or 
stabilizers for polymers (21 CFR 178.2010) be amended to provide for 
the safe use of oxidized bis(hydrogenated tallow alkyl)amines (CAS Reg. 
No. 143925-92-2) as a process stabilizer for polypropylene intended for 
use in contact with food.
    FDA has evaluated data in the petition and other relevant material. 
The agency is not including the Chemical Abstracts Service Registry 
number (CAS Reg. No. 143925-92-2) in the regulation because it 
corresponds to the pure hydroxylamine component of the additive and not 
to the additive itself. The agency concludes that the proposed food 
additive use is safe, and 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 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 October 26, 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 

[[Page 49507]]
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 under the headings ``Substances'' and 
``Limitations'' to read as follows:


Sec. 178.2010  Antioxidants and/or stabilizers for polymers.

 * * * * *
    (b) * * *

                                                                        
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             Substances                          Limitations            
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                      *      *      *      *      *                     
Oxidized bis(hydrogenated tallow     For use only at levels not to      
 alkyl)amines.                        exceed 0.05 percent by weight of  
                                      olefin polymers complying with    
                                      Sec.  177.1520(c) of this chapter,
                                      item 1.1, 1.2, or 1.3: The        
                                      finished polymers may be used in  
                                      contact with food types I, II, IV-
                                      B, VII-B, and VIII described in   
                                      Table 1 of Sec.  176.170(c) of    
                                      this chapter, under conditions of 
                                      use B through H described in Table
                                      2 of Sec.  176.170(c) of this     
                                      chapter, and with food types III, 
                                      IV-A, V, VI, VII-A, and IX        
                                      described in Table 1 of Sec.      
                                      176.170(c) of this chapter, under 
                                      conditions of use D through H     
                                      described in Table 2 of Sec.      
                                      176.170(c) of this chapter.       
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    Dated: September 13, 1995.
Janice F. Oliver,
Deputy Director for Systems and Support, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 95-23776 Filed 9-25-95; 8:45 am]
BILLING CODE 4160-01-F