[Federal Register Volume 60, Number 185 (Monday, September 25, 1995)]
[Rules and Regulations]
[Pages 49337-49339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23598]



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[[Page 49338]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178

[Docket No. 95F-0149]


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 phosphorous acid, 
cyclic butylethyl propanediol, 2,4,6-tri-tert-butylphenyl ester as an 
antioxidant and/or stabilizer in olefin polymers intended for use in 
contact with food. This action is in response to a petition filed by 
General Electric Co.

DATES: Effective September 25, 1995; written objections and requests 
for a hearing by October 25, 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: 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 June 21, 1995 (60 FR 32329), FDA announced that a food 
additive petition (FAP 5B4463) had been filed by General Electric Co., 
501 Avery St., Parkersburg, WV 26102-1868. The petition proposed 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 
safe use of phosphorous acid, cyclic butylethyl propanediol, 2,4,6-tri-
tert-butylphenyl ester as an antioxidant and/or stabilizer in olefin 
polymers 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 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 25, 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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  *                    *                    *                    *      
                   *                    *                    *          
Phosphorous acid, cyclic butylethyl  For use only at levels not to      
 propanediol, 2,4,6-tri-tert-         exceed 0.2 percent by weight of   
 butylphenyl ester (CAS Reg. No.      olefin polymers complying with    
 161717-32-4).                        Sec.  177.1520(c) of this chapter,
                                      items 1.1, 1.2, or 1.3, and items 
                                      2.1, 2.2, or 2.3 (where the       
                                      density of these polymers is not  
                                      less than 0.94 gram per cubic     
                                      centimeter), and items 3.1 or 3.2,
                                      provide that the finished polymer 
                                      contacts food only of types I, II,
                                      and VI-B as described in Table 1  
                                      of Sec.  176.170(c) of this       
                                      chapter only under conditions of  
                                      use B, C, D, E, F, G, and H as    
                                      described in Table 2 of Sec.      
                                      176.170(c) of this chapter.       
  *                    *                    *                    *      
                   *                    *                    *          
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[[Page 49339]]

    Dated: September 15, 1995.
 Janice F. Oliver,
Deputy Director for Systems and Support, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 95-23598 Filed 9-22-95; 8:45 am]
BILLING CODE 4160-01-F