[Federal Register Volume 60, Number 31 (Wednesday, February 15, 1995)]
[Rules and Regulations]
[Pages 8545-8547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3804]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 91F-0271]


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 , 3(or 4)-
bis(octadecylthio)cyclohexylethane as an antioxidant for general use in 
polymeric food-contact articles. This action is in response to a 
petition filed by Atochem North America, Inc.

DATES: Effective February 15, 1995; written objections and requests for 
a hearing by March 17, 1995.

[[Page 8546]] 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: Vir Anand, Center for Food Safety and 
Applied Nutrition (HFS-216), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, 202-254-9500.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 8, 1991 (56 FR 37712), FDA announced that a food 
additive petition (FAP 1B4274) had been filed by Atochem North America, 
Inc., c/o 1150 17th St. NW., Washington, DC 20036 (presently, 1001 G 
St. NW, suite 500 West, Washington, DC 20001). The petition proposed 
that the food additive regulations be amended in Sec. 176.170 
Components of paper and paperboard in contact with aqueous and fatty 
foods (21 CFR 176.170) to provide for the safe use of  , 3(or 
4)-bis(octadecylthio)cyclohexylethane as an antioxidant in polymeric 
articles intended for food-contact uses. The agency reviewed the 
nomenclature of the additive and has determined that to ensure 
unambiguous identification of the compound, a synonym compatible with 
the Chemical Abstract Service nomenclature, namely, 1-[(beta-
(octadecylthio)ethyl]-3(or 4)-(octadecylthio)cyclohexane, should be 
included in this final rule.
    Upon further review of the petition, the agency noted that the 
petitioner had requested use of the additive for general use in 
polymers rather than as an additive for paper and paperboard. In a 
notice published in the Federal Register of September 11, 1991 (56 FR 
46323), FDA amended the filing notice of August 8, 1991, to state that 
the petitioner had requested that the food additive regulations be 
amended in Sec. 178.2010 Antioxidants and/or stabilizers for polymers 
(21 CFR 178.2010) to provide for the use of , 3(or 4)-
bis(octadecylthio)cyclohexylethane as an antioxidant for general use in 
polymeric food-contact articles.
    FDA has evaluated the data in the petition and other relevant 
material. The agency concludes that the proposed use of the additive 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 March 17, 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 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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  *                    *                    *                    *      
                   *                    *                    *          
 , 3(or 4)-                 For use only:                      
 Bis(octadecylthio)cyclohexylethane                                     
 (CAS Reg. No. 37625-75-5); CAS                                         
 synonym: 1-[(beta-                                                     
 (octadecylthio)ethyl]-3(or 4)-                                         
 (octadecylthio)cyclohexane.                                            
                                     1. At levels not to exceed 0.3     
                                      percent by weight of all polymers 
                                      for use in contact with foods of  
                                      Types I, II, IV-B, VI, VII-B, and 
                                      VIII under conditions of use B    
                                      through H as described in Tables 1
                                      and 2 of Sec. 176.170(c) of this  
                                      chapter.                          
                                     2. At levels not to exceed 0.3     
                                      percent by weight of polyolefins  
                                      complying with Sec. 177.1520 of   
                                      this chapter, for use in contact  
                                      with food of types III, IV-A, V,  
                                      VII-A, and IX under conditions of 
                                      use C through G as described in   
                                      Tables 1 and 2 of Sec. 176.170(c) 
                                      of this chapter.                  
  *                    *                    *                    *      
                   *                    *                    *          
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    [[Page 8547]] Dated: February 3, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-3804 Filed 2-14-95; 8:45 am]
BILLING CODE 4160-01-F