[Federal Register Volume 59, Number 17 (Wednesday, January 26, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1422]


[[Page Unknown]]

[Federal Register: January 26, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 93F-0361]

 

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 4-[[5-[[[4-
(aminocarbonyl)phenyl] amino]carbonyl]-2-methoxyphenyl]azo]-N-(5-
chloro-2,4-dimethoxyphenyl)-3-hydroxy-2-naphthalenecarboxamide (C.I. 
Pigment Red 187) as a colorant for all polymers intended for use in 
contact with food. This action is in response to a petition filed by 
Hoechst Celanese Corp.

DATES: Effective January 26, 1994; written objections and requests for 
a hearing by February 25, 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 October 29, 1993 (58 FR 58172), FDA announced that a food 
additive petition (FAP 3B4402) had been filed by Hoechst Celanese 
Corp., 500 Washington St., Coventry, RI 02186, proposing that 
Sec. 178.3297 Colorants for polymers (21 CFR 178.3297) be amended to 
provide for the safe use of 4-[[5-[[[4-aminocarbonyl)phenyl] amino]carb 
onyl]-2-methoxy phenyl] azo]-N-(5-chloro-2,4-dimethoxy phenyl)-3-
hydroxy-2-naphthalenecarboxa mide (C.I. Pigment Red 187) 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 additive is safe and 
that 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 February 25, 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).

    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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                                 *******                                
4-[[5-[[[4-(Aminocarbonyl) phenyl]   For use at levels not to exceed 1  
 amino]carbonyl]- 2-                  percent by weight of polymers. The
 methoxyphenyl]azo]-N-(5-chloro-2,4-  finished articles are to contact  
 dimethoxyphenyl)-3-hydroxy-2-        foods only under conditions of use
 naphthalene-carboxamide (C.I.        B through H described in Table 2  
 Pigment Red 187, CAS Reg. No.        of Sec. 176.170(c) of this        
 59487-23-9).                         chapter.                          
                                *******                                 
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    Dated: January 11, 1994.
 Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-1422 Filed 1-25-94; 8:45 am]
BILLING CODE 4160-01-F