[Federal Register Volume 66, Number 14 (Monday, January 22, 2001)]
[Rules and Regulations]
[Pages 6469-6470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1565]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 99F-2336]


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 manganese ammonium 
pyrophosphate (C.I. Pigment Violet 16) as a colorant for all polymers 
intended for use in contact with food. This action is in response to a 
petition filed by Holliday Pigments, Ltd.

DATES:  This rule is effective January 22, 2001. Submit written 
objections and requests for a hearing by February 21, 2001.

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: Mark A. Hepp, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3098.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of July 21, 1999 (64 FR 39146), FDA announced that a food 
additive petition (FAP 9B4670) had been filed by Holliday Pigments, 
Ltd., Morley St., Kingston upon Hull, HU8 8DN ENGLAND. 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 
manganese ammonium pyrophosphate (C.I. Pigment Violet 16) as a colorant 
for all polymers intended for use in contact with food.
    FDA has evaluated the 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 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.
    This final rule contains no collections 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 file with the Dockets Management Branch (address above) 
written objections by February 21, 2001. 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 are to be 
submitted 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.

* * * * *
    (e) * * *

[[Page 6470]]



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             Substances                          Limitations
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  *                    *                    *                    *
                   *                    *                    *
Manganese Violet (manganese          For use at levels not to exceed 2
 ammonium pyrophosphate; CAS Reg.     percent by weight of polymers. The
 No. 10101-66-3).                     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: December 27, 2000.
Janice F. Oliver,
Deputy Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 01-1565 Filed 1-19-01; 8:45 am]
BILLING CODE 4160-01-F