[Federal Register Volume 62, Number 148 (Friday, August 1, 1997)]
[Rules and Regulations]
[Pages 41271-41272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20390]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 95F-0170]


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 2,4-dimethyl-6-(1-
methylpentadecyl)phenol as an antioxidant and/or stabilizer in 
acrylonitrile-butadiene-styrene copolymers and in rigid polyvinyl 
chloride intended for food-contact applications. This action is in 
response to a petition filed by Ciba-Geigy Corp.

DATES: Effective August 1, 1997. Written objections and requests for a 
hearing by September 2, 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 July 12, 1995 (60 FR 35913), FDA announced that a food 
additive petition (FAP 5B4468) had been filed by Ciba-Geigy Corp., 
Seven Skyline Dr., Hawthorne, NY 10532-2188. 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 safe 
use of 2,4-dimethyl-6-(1-methylpentadecyl)phenol as an antioxidant and/
or stabilizer in acrylonitrile-butadiene-styrene copolymers and in 
rigid polyvinyl chloride intended for food-contact applications.
    FDA has evaluated data in the petition and other relevant material. 
Based on this information, the agency concludes that the proposed use 
of the additive as an antioxidant and/or stabilizer in acrylonitrile-
butadiene-styrene copolymers and in rigid polyvinyl chloride intended 
for food-contact applications 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 September 2, 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.

[[Page 41272]]

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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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
2,4-Dimethyl-6-(1-methylpentadecyl)phenol (CAS Reg. No.  For use only:                                          
 134701-20-5)                                            1. At levels not to exceed 0.3 percent by weight of    
                                                          acrylonitrile-butadiene-styrene copolymers used in    
                                                          accordance with applicable regulations in parts 175,  
                                                          176, 177, and 181 of this chapter, under conditions of
                                                          use C through H as described in Table 2 of Sec.       
                                                          176.170(c) of this chapter.                           
                                                         2. At levels not to exceed 0.033 percent by weight of  
                                                          rigid polyvinyl chloride, under conditions of use A   
                                                          through H as described in Table 2 of Sec.  176.170(c) 
                                                          of this chapter.                                      
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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    Dated: July 24, 1997.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 97-20390 Filed 7-31-97; 8:45 am]
BILLING CODE 4160-01-F