[Federal Register Volume 61, Number 127 (Monday, July 1, 1996)]
[Rules and Regulations]
[Pages 33846-33847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16662]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 96F-0052]


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 additional safe use of 
dimethyldibenzylidene sorbitol as a clarifying agent for propylene 
homopolymers and high-propylene copolymer articles intended for contact 
with food. This action is in response to a petition filed by Milliken & 
Co.

DATES: Effective July 1, 1996; written objections and requests for a 
hearing by July 31, 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: 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 February 26, 1996 (61 FR 7111), FDA announced that a food 
additive petition (FAP 6B4495) had been filed by Milliken & Co., 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. 178.3295 Clarifying agents for polymers (21 CFR 178.3295) to 
provide for the additional safe use of dimethyldibenzylidene sorbitol 
as a clarifying agent for olefin polymers complying with Sec. 177.1520 
(21 CFR 177.1520), items 1.1, 3.1, and 3.2, for contact with food under 
condition of use A, described in Table 2 of Sec. 176.170(c) of this 
chapter.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that the proposed use of the additive is safe, 
that the additive will have the intended technical effect, and that the 
regulations in Sec. 178.3295 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.
    Any person who will be adversely affected by this regulation may at 
any time on or before July 31, 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 
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

[[Page 33847]]

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 178.3295 is amended in the table by revising the entry 
for ``Dimethyldibenzylidene sorbitol'' to read as follows:


Sec. 178.3295  Clarifying agents for polymers.

* * * * *

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                Substances                           Limitations        
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                      *      *      *      *      *                     
Dimethyldibenzylidene sorbitol (CAS Reg.    For use only as a clarifying
 No 135861-56-2).                            agent at a level not to    
                                             exceed 0.4 percent by      
                                             weight of olefin polymers  
                                             complying with Sec.        
                                             177.1520(c) of this        
                                             chapter, items 1.1, 3.1,   
                                             and 3.2, where the         
                                             copolymers complying with  
                                             items 3.1 and 3.2 contain  
                                             not less than 85 weight    
                                             percent of polymer units   
                                             derived from polypropylene.
                                             The finished polymers shall
                                             be used in contact with    
                                             food under conditions of   
                                             use A through H described  
                                             in Table 2 of Sec.         
                                             176.170(c) of this chapter.
                      *      *      *      *      *                     
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    Dated: June 12, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-16662 Filed 6-28-96; 8:45 am]
BILLING CODE 4160-01-F