[Federal Register Volume 62, Number 124 (Friday, June 27, 1997)]
[Rules and Regulations]
[Pages 34628-34629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16794]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 97F-0004]


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-(4,6-diphenyl-
1,3,5-triazin-2-yl)-5-(hexyloxy)phenol as a light stabilizer/
ultraviolet (UV) absorber for polycarbonate resins and polyester 
elastomers intended for use in contact with food. This action is in 
response to a petition filed by Ciba Specialty Chemicals Corp.

DATES: Effective June 27, 1997; written objections and requests for a 
hearing by July 28, 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: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-215), 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 January 16, 1997 (62 FR 2373), FDA announced that a food 
additive petition (FAP 7B4531) had been filed by Ciba Specialty 
Chemicals Corp., 540 White Plains Rd., Tarrytown, NY 10591-9005. 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- (4,6-diphenyl-1,3,5-
triazin-2-yl)-5-(hexyloxy)phenol as a light stabilizer/UV absorber for 
polycarbonate resins complying with 21 CFR 177.1580 and polyester 
elastomers complying with 21 CFR 177.1590 intended for use in contact 
with food.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that: (1) The proposed use of the additive is 
safe, (2) the additive will achieve its intended technical effect, and 
(3) 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

[[Page 34629]]

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.
    Any person who will be adversely affected by this regulation may at 
any time on or before July 28, 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 objection 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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  *                    *                    *                    *      
                   *                    *                    *          
2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5-     For use only                 
 hexyloxy)phenol (CAS Reg. No. 147315-50-  1. At levels not to exceed   
 2).                                        0.5 percent by weight of    
                                            polycarbonate resins        
                                            complying with Sec.         
                                            177.1580 of this chapter.   
                                           2. At levels not to exceed   
                                            0.5 percent by weight of    
                                            polyester elastomers        
                                            complying with Sec.         
                                            177.1590 of this chapter.   
  *                    *                    *                    *      
                   *                    *                    *          
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    Dated: June 16, 1997.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 97-16794 Filed 6-26-97; 8:45 am]
BILLING CODE 4160-01-F