[Federal Register Volume 59, Number 26 (Tuesday, February 8, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2880]


[[Page Unknown]]

[Federal Register: February 8, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 93F-0297]

 

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 N-[4-
(aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-
yl)amino]carbonyl]-2-oxopropyl]azo]benzamide (C. I. Pigment Yellow 181) 
as a colorant in all polymers intended for use in contact with food. 
This action is in response to a petition filed by Hoechst Celanese 
Corp.

DATES: Effective February 8, 1994; written objections and requests for 
a hearing by March 10, 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 September 17, 1993 (58 FR 48659), FDA announced that a food 
additive petition (FAP 3B4393) had been filed by Hoechst Celanese 
Corp., 500 Washington St., Coventry, RI 02816. The petition proposed 
that Sec. 178.3297 Colorants for polymers (21 CFR 178.3297) be amended 
to provide for the safe use of N-[4-(aminocarbonyl)phenyl]-4-[[1-
[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-
oxopropyl]azo]benzamide (C. I. Pigment Yellow 181) as a colorant in all 
polymers intended 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 Sec. 178.3297(e) 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 March 10, 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 178.3297 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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                                 *******                                
N-[4-(Aminocarbonyl)phenyl]-4-[[1-   For use at levels not to exceed 1  
 [[(2,3-dihydro-2-oxo-1H-             percent by weight of polymers. The
 benzimidazol-5-yl)amino]carbonyl]-   finished articles are to contact  
 2-oxopropyl]azo]benzamide (C. I.     food only under conditions of use 
 Pigment Yellow 181, CAS Reg. No.     B through H described in Table 2  
 74441-05-7).                         of Sec. 176.170(c) of this        
                                      chapter.                          
                                 *******                                
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    Dated: January 31, 1994.
 Fred R. Shank,
 Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-2880 Filed 2-7-94; 8:45 am]
BILLING CODE 4160-01-F