[Federal Register Volume 62, Number 76 (Monday, April 21, 1997)]
[Rules and Regulations]
[Pages 19220-19221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10252]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 96F-0245]


Indirect Food Additives: Adjuvants, Production Aids, and 
Sanitizers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the expanded safe use of 4-chloro-
2-[[5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H-pyrazol-4-yl]azo]-5-
methylbenzenesulfonic acid, calcium salt (1:1); (C.I. Pigment Yellow 
191) 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 April 21, 1997; written objections and requests for a 
hearing by May 21, 1997.

.ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration,

[[Page 19221]]

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 August 27, 1996 (61 FR 44066), FDA announced that a food 
additive petition (FAP 6B4493) had been filed by Hoechst Celanese 
Corp., 500 Washington St., Coventry, RI 02816. The petition proposed to 
amend the food additive regulations in Sec. 178.3297 Colorants for 
polymers (21 CFR 178.3297) to provide for the expanded safe use of 4-
chloro-2-[[5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H-pyrazol-4-yl]azo]-5-
methylbenzenesulfonic acid, calcium salt (1:1); (C.I. Pigment Yellow 
191) as a colorant for 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, 
that the additive will achieve its intended technical effect, and 
therefore, 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 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. No comments were received during the 30-day comment 
period specified in the filing notice for comments on the environmental 
assessment submitted with the petition.
    Any person who will be adversely affected by this regulation may at 
any time on or before May 21, 1997, 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 
revising the entry for 4-Chloro-2-[[5-hydroxy-3-methyl-1-(3-
sulfophenyl)-1H-pyrazol-4-yl]azo]5-methylbenzenesulfonic acid, calcium 
salt (1:1); (C.I. Pigment Yellow 191), under the heading 
``Limitations'' to read as follows:


Sec. 178.3297  Colorants for polymers.

* * * * *
    (e) * * *

                                                                        
------------------------------------------------------------------------
                Substances                           Limitations        
------------------------------------------------------------------------
                      *      *      *      *      *                     
4-Chloro-2-[[5-hydroxy-3-methyl-1-(3-       For use at levels not to    
 sulfophenyl)-1H-pyrazol-4-yl]azo]-5-        exceed 1.0 percent by      
 methylbenzenesulfonic acid, calcium salt    weight of the finished     
 (1:1); (C.I. Pigment Yellow 191, CAS Reg.   polymers. The finished     
 No. 129423-54-7).                           articles are to contact    
                                             food only under conditions 
                                             of use B through H as      
                                             described in Table 2 of    
                                             Sec.  176.170(c) of this   
                                             chapter.                   
                      *      *      *      *      *                     
------------------------------------------------------------------------

* * *

    Dated: April 1, 1997.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 97-10252 Filed 4-18-97; 8:45 am]
BILLING CODE 4160-01-F