[Federal Register Volume 59, Number 56 (Wednesday, March 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6764]


[[Page Unknown]]

[Federal Register: March 23, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 93F-0112]

 

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 
dimethyldibenzylidene sorbitol as a clarifying agent for polypropylene 
and high-propylene olefin copolymers intended for use in contact with 
food. This action is in response to a petition filed by Milliken 
Chemical.

DATES: Effective March 23, 1994; written objections and requests for a 
hearing by April 22, 1994.

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, 202-254-9500.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of April 22, 1993 (58 FR 21583), FDA announced that a food 
additive petition (FAP 2B4341) had been filed by Milliken Chemical, c/o 
1001 G St. NW., suite 500 West, Washington, DC 20001, proposing that 
Sec. 178.3295 Clarifying agents for polymers (21 CFR 178.3295) be 
amended to provide for the safe use of dimethyldibenzylidene sorbitol 
as a clarifying agent in polypropylene articles intended for use in 
contact with food.
    Upon further review of the petition, the agency noted that the 
petitioner had requested use of the additive as a clarifying agent in 
high-propylene olefin copolymers in addition to its use in 
polypropylene films. In a notice published in the Federal Register of 
January 4, 1994 (59 FR 307), FDA amended the filing notice of April 22, 
1993, to state that the petitioner had requested that the food additive 
regulations be amended to provide for the safe use of 
dimethyldibenzylidene sorbitol as a clarifying agent in polypropylene 
and high-propylene olefin copolymers 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 food additive is safe 
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 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 (insert date 30 days after date of publication in 
the Federal Register), 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 178.3295 is amended in the table by alphabetically 
adding a new entry under the headings ``Substances'' and 
``Limitations'' to read as follows:

Sec. 178.3295  Clarifying agents for polymers.

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            Substances                           Limitations            
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Dimethyldibenzylidene sorbitol (CAS  For use only as a clarifying agent 
 Reg. No. 135861-56-2).               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; in    
                                      contact with all food types under 
                                      conditions of use B, C, D, E, F,  
                                      G, and H, described in Table 2 of 
                                      Sec. 176.170(c) of this chapter.  
                                                                        
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    Dated: March 14, 1994.
 L. Robert Lake,
 Acting Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-6764 Filed 3-22-94; 8:45 am]
BILLING CODE 4160-01-F