[Federal Register Volume 62, Number 141 (Wednesday, July 23, 1997)]
[Rules and Regulations]
[Pages 39441-39442]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19250]



[[Page 39441]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 96F-0051]


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 expand the safe use of oxidized bis 
(hydrogenated tallow alkyl) amines as a process stabilizer for 
polypropylene homo- and copolymers and high-density polyethylene homo- 
and copolymers intended for use in contact with food. This action is in 
response to a petition filed by Ciba-Geigy Corp.

DATES: Effective July 23, 1997; written objections and requests for a 
hearing by August 22, 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: Mark A. Hepp, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3098.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of February 23, 1996 (61 FR 7005), FDA announced that a food 
additive petition (FAP 6B4491) had been filed by Ciba-Geigy Corp., 540 
White Plains Rd., P.O. Box 2005, Tarrytown, NY 10591-9005 (zip code was 
incorrectly identified as 10591-4311). The petition proposed to amend 
the food additive regulations in Sec. 178.2010 Antioxidants and/or 
stabilizers for polymers (21 CFR 178.2010) to expand the safe use of 
oxidized bis (hydrogenated tallow alkyl) amines as a process stabilizer 
for polypropylene homo- and copolymers and high-density polyethylene 
homo- and copolymers 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 as a process 
stabilizer for polypropylene homo- and copolymers and high-density 
polyethylene homo- and copolymers is safe and that the additive will 
have the intended technical effect. Therefore, 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. No comments were received during the 30-day comment 
period specified in the filing notice for comments on the environmental 
assessment submitted with the petition.
    Any person who will be adversely affected by this regulation may at 
any time on or before August 22, 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 ``Limitations'' for the entry ``Oxidized bis (hydrogenated 
tallow alkyl) amines'' to read as follows:

Sec. 178.2010  Antioxidants and/or stabilizers for polymers.

* * * * *
    (b) *   *   *

[[Page 39442]]



                                                                                                                
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                       Substances                                              Limitations                      
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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
Oxidized bis (hydrogenated tallow alkyl) amines          For use only:                                          
                                                         1. At levels not to exceed 0.1 percent by weight of    
                                                          polypropylene polymers complying with Sec.            
                                                          177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 3.1a 
                                                          (density not less than 0.85 gram per cubic centimeter 
                                                          and less than 0.91 gram per cubic centimeter), 3.2b,  
                                                          3.4, and 3.5. 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.       
                                                         2. At levels not to exceed 0.075 percent by weight of  
                                                          high-density polyethylene polymers complying with Sec.
                                                           177.1520(c) of this chapter, item 2.1, 2.2, 2.3,     
                                                          3.1a, 3.1b, 3.2a, 3.6 (density not less than 0.94 gram
                                                          per cubic centimeter), and 5. 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: July 3, 1997.
Janice F. Oliver,
Deputy Director for Systems and Support, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 97-19250 Filed 7-22-97; 8:45 am]
BILLING CODE 4160-01-F