[Federal Register Volume 60, Number 114 (Wednesday, June 14, 1995)]
[Rules and Regulations]
[Pages 31243-31244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-14464]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 94F-0451]


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 copper chromite 
black spinel as a colorant for all polymers intended to contact food. 
This action is in response to a petition filed by The Shepherd Color 
Co.

DATES: Effective June 14, 1995; written objections and request for a 
hearing by July 14, 1995.
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, 202-418-3081.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of January 12, 1995 (60 FR 2976), FDA announced that a food 
additive petition (FAP 5B4446) had been filed by The Shepherd Color 
Co., 4539 Dues Dr., Cincinnati, OH 45246. 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 copper 
chromite black spinel (C.I. Pigment Black 28) as a colorant in all 
polymers intended to contact food.
    FDA has evaluated the 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 July 14, 1995, file with the Dockets Management 
Branch (address above) written objections 

[[Page 31244]]
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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  *                      *                    *                    *    
                    *                    *                    *         
Copper chromite black spinel (C.I.   For use at levels not to exceed 5  
 Pigment Black 28, CAS Reg. No.       percent by weight of polymers. The
 68186-91-4).                         finished articles are to contact  
                                      food only under conditions of use 
                                      A through H as described in Table 
                                      2 of Sec. 176.170(c) of this      
                                      chapter.                          
  *                      *                    *                    *    
                    *                    *                    *         
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    Dated: May 26, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-14464 Filed 6-13-95; 8:45 am]
BILLING CODE 4160-01-F