[Federal Register Volume 59, Number 93 (Monday, May 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11785]


[[Page Unknown]]

[Federal Register: May 16, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178

[Docket No. 92F-0162]

 

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 expand the safe use of sodium 2,2'-
methylenebis(4,6-di-tert-butylphenyl)phosphate as a clarifying agent in 
polypropylene articles intended for contact with all types of food to 
include frozen or refrigerated storage of ready-prepared foods intended 
to be reheated in the container at the time of use. This action is in 
response to a petition filed by Asahi Denka Kogyo K. K.

DATES: Effective May 16, 1994; written objections and requests for a 
hearing by June 15, 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 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 May 4, 1992 (57 FR 19133), FDA announced that a food 
additive petition (FAP 2B4300) had been filed by Asahi Denka Kogyo K. 
K., c/o Japan Technical Information Center, Inc., 1002 Pennsylvania 
Ave. SE., Washington, DC 20003, proposing that the food additive 
regulations be amended in Sec. 178.3295 Clarifying agents for polymers 
(21 CFR 178.3295) to expand the safe use of sodium 2,2'-
methylenebis(4,6-di-tert-butylphenyl)phosphate (CAS Reg. No. 85209-1-2) 
as a clarifying agent in polypropylene articles intended for 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. 178.3295 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 June 15, 1994, 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 revising the entry 
for ``Sodium 2,2'-methylenebis(4,6-di-tert-butylphenyl)phosphate'' to 
read as follows:


Sec. 178.3295  Clarifying agents for polymers.

* * * * * 

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             Substances                          Limitations            
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                                 *******                                
Sodium 2,2'- methylenebis(4,6-di-    For use only as a clarifying agent 
 tert-butylphenyl)phosphate (CAS      at a level not exceeding 0.30     
 Reg. No. 85209-91-2).                percent by weight of olefin       
                                      polymers complying with Sec.      
                                      177.1520(c) of this chapter, items
                                      1.1, 3.1, or 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 contact foods   
                                      only of types I, II, IV-B, VI-B,  
                                      VII-B, and VIII as identified in  
                                      Table 1 of Sec. 176.170(c) of this
                                      chapter and limited to conditions 
                                      of use B through H described in   
                                      Table 2 of Sec. 176.170(c) of this
                                      chapter, or foods of all types,   
                                      limited to conditions of use C    
                                      through H described in Table 2 of 
                                      Sec. 176.170(c) of this chapter.  
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    Dated: May 6, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-11785 Filed 5-13-94; 8:45 am]
BILLING CODE 4160-01-F