[Federal Register Volume 61, Number 180 (Monday, September 16, 1996)]
[Rules and Regulations]
[Pages 48623-48624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-23549]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 92F-0117]


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 a mixture of 
methylated 4,4'-bis(2-benzoxazolyl)stilbenes, with the major portion 
consisting of 4-(2-benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene 
and lesser portions consisting of 4,4'-bis(5-methyl-2-
benzoxazolyl)stilbene and 4,4'-bis(2-benzoxazolyl) stilbene, as an 
optical brightener in all food-contact polymers. This action is in 
response to a petition filed by Hoechst Aktiengesellschaft.

DATES: Effective September 16, 1996; written objections and requests 
for a hearing by October 16, 1996.

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: Ellen M. Waldron, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-606-0202.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of April 8, 1992 (57 FR 11958), FDA announced that a food 
additive petition (FAP 2B4317) had been filed by Hoechst 
Aktiengesellschaft,
c/o Keller and Heckman, 1001 G St. NW., suite 500 West, Washington, DC 
20001. The petition proposed to amend the food additive regulations in 
Sec. 178.3297 Colorants for polymers (21 CFR 178.3297) to provide for 
the safe use of a mixture of methylated 4,4'-bis(2-benzoxazolyl) 
stilbenes, with the major portion consisting of 4-(2-benzoxazolyl)-4'-
(5-methyl-2-benzoxazolyl) stilbene and lesser portions consisting of 
4,4'-bis(5-methyl-2-benzoxazolyl) stilbene and 4,4'-bis(2-benzoxazolyl) 
stilbene, as an optical brightener in all food-contact polymers. 
(Because of a printing error, 4,4'-bis(5-methyl-2-benzoxazolyl) 
stilbene was not listed in the filing notice summary as a lesser 
component of the proposed additive. However, the correct composition of 
the additive was given in the supplemental information section of the 
filing notice.)
    FDA has evaluated the data in the petition and other relevant 
material. Based on this information, the agency concludes that the 
proposed use of the additive is safe, that the additive will achieve 
its intended technical effect, and that therefore, the regulations in 
Sec. 178.3297 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 16, 1996 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 
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

[[Page 48624]]

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 178.3297 is amended in the table in paragraph (e) by 
alphabetically adding a new entry under the headings ``Substances'' and 
``Limitations'' to read as follows:


Sec. 178.3297  Colorants for polymers.

* * * * *
    (e) * * *

                                                                        
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                Substances                          Limitations         
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  *                    *                    *                    *      
                   *                    *                    *          
Mixed methylated 4,4'-bis(2-               For use as an optical        
 benzoxazolyl)stilbenes with the major      brightener only at levels   
 portion consisting of 4-(2-benzoxazolyl)-  not to exceed 0.05 percent  
 4'-(5-methyl-2-benzoxazolyl)stilbene       by weight of rigid and      
 (CAS Registry No. 5242-49-9) and lesser    semirigid polyvinyl chloride
 portions consisting of 4,4'-bis(5-methyl-  and not to exceed 0.03      
 2-benzoxazolyl)stilbene (CAS Registry      percent by weight in all    
 No. 2397-00-4) and 4,4'-bis(2-             other polymers. The finished
 benzoxazolyl)stilbene (CAS Registry No.    food-contact articles shall 
 1533-45-5).                                be used only under          
                                            conditions of use D, E, F,  
                                            and G described in Table 2  
                                            of Sec.  176.170(c) of this 
                                            chapter.                    
  *                    *                    *                    *      
                   *                    *                    *          
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    Dated: August 28, 1996.
 Fred R. Shank,
 Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-23549 Filed 9-13-96; 8:45 am]
BILLING CODE 4160-01-F