[Federal Register Volume 63, Number 158 (Monday, August 17, 1998)]
[Rules and Regulations]
[Pages 43873-43874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22091]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 97F-0467]


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 benzenesulfonic 
acid, 4-chloro-5-methyl-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-
sulfophenyl)-1H-pyrazo-4-yl]azo], ammonium salt (C.I. Pigment Yellow 
191:1) as a colorant in polymers intended for use in contact with food. 
This action is in response to a petition filed by Ciba Specialty 
Chemicals Corp.

DATES: The regulation is effective August 17, 1998. Submit written 
objections and requests for a hearing by September 16, 1998.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-215), 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 November 19, 1997 (62 FR 61823), FDA announced that a food 
additive petition (FAP 8B4566) had been filed by Ciba Specialty 
Chemicals Corp., 335 Water St., Newport, DE 19804 (presently, c/o 
Keller and Heckman, 1001 G St. NW., suite 500 West, Washington, DC 
20001). The petition proposed to amend the food additive regulations in 
Sec. 178.3297 Colorants for polymers (21 CFR 178.3297) to provide for 
the safe use of benzenesulfonic acid, 4-chloro-5-methyl-2-[[4,5-
dihydro-3-methyl-5-oxo-1-(3-sulfophenyl)-1H-pyrazo-4-yl]azo], ammonium 
salt (C.I. Pigment Yellow 191:1) as a colorant in polymers intended for 
use in contact with food. In this final rule the agency is using the 
alternate name 4-chloro-2-[[5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H-
pyrazol-4-yl]azo]-5-methylbenzenesulfonic acid, diammonium salt (1:2), 
(C.I. Pigment Yellow 191:1).
    FDA has evaluated data in the petition and other relevant material. 
Based on this information, 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 rule as announced in the notice of filing for FAP 
8B4566 (62 FR 61823). No new information or comments have been received 
that would affect the agency's previous determination that there is no 
significant impact on the human environment and that an environmental 
impact statement is not required.
    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.
    Any person who will be adversely affected by this regulation may at 
any time on or before September 16, 1998, 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: 21 U.S.C. 321, 342, 348, 379e.

    2. Section 178.3297 is amended in the table in paragraph (e) by 
alphabetically adding an entry under the headings ``Substances'' and 
``Limitations'' to read as follows:

Sec. 178.3297   Colorants for polymers.

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    (e) * * *

[[Page 43874]]



                                                                                                                
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                       Substances                                               Limitations                     
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  *                    *                    *                    *                    *                    *    
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 4-Chloro-2-[[5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H-    For use at levels not to exceed 0.5 percent by weight 
 pyrazol-4-yl]azo]-5-methylbenzenesulfonic acid,          of polymers. The finished articles are to contact food
 diammonium salt (1:2): (C.I. Pigment Yellow 191:1, CAS   under conditions of use A through H described in Table
 Reg. No. 154946-66-4).                                   2 of Sec.  176.170(c) of this chapter.                
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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    Dated: July 30, 1998.
Janice F. Oliver,
Deputy Director for Systems and Support, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 98-22091 Filed 8-14-98; 8:45 am]
BILLING CODE 4160-01-F