[Federal Register Volume 64, Number 95 (Tuesday, May 18, 1999)]
[Rules and Regulations]
[Pages 26841-26842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12396]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 98F-0824]


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 anthra(2,1,9-
def:6,5,10-d'e'f')diisoquinoline-1,3,8,10 (2H,9H)-tetrone (C.I. Pigment 
Violet 29) as a colorant for polymers intended for use in contact with 
food. This action is in response to a petition filed by BASF Corp.

DATES: Effective May 18, 1999; written objections and requests for a 
hearing by June 17, 1999.
ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-

[[Page 26842]]

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 October 6, 1998 (63 FR 53679), FDA announced that a food 
additive petition (FAP 8B4626) had been filed by BASF Corp., 3000 
Continental Dr. North, Mt. Olive, NJ 07828-1234. 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 anthra(2,1,9-
def:6,5,10-d'e'f')diisoquinoline-1,3,8,10(2H,9H)-tetrone (C.I. Pigment 
Violet 29) as a colorant for polymers intended for use in contact with 
food.
     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 as a colorant for all polymers intended 
for use in contact with food is safe and that the additive will have 
the intended technical effect. Therefore, the regulations in 
Sec. 178.3297 should be amended as set forth below.
     In accordance with Sec. 171.1(h) (21CFR 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 previously considered the potential environmental 
effects of this rule as announced in the notice of filing for the 
petition. 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 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 on or before June 17, 1999 file with the Dockets Management 
Branch (address above) a written objection 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 objection 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 for anthra(2,1,9-def:6,5,10-
d'e'f')diisoquinoline-1,3,8,10(2H,9H)-tetrone (C.I. Pigment Violet 29) 
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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  *                    *                    *                    *
                   *                    *                    *
Anthra(2,1,9-def:6,5,10-             For use at levels not to exceed 1%
 d'e'f')diisoquinoline-               by weight of polymers. The
 1,3,8,10(2H,9H)-tetrone (C.I.        finished articles are to contact
 Pigment Violet 29; CAS Reg. No. 81-  food only under conditions of use
 33-4)                                B through H as described in Table
                                      2 of Sec.  176.170(c) of this
                                      chapter.
  *                    *                    *                    *
                   *                    *                    *
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    Dated: May 5, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-12396 Filed 5-17-99 8:45 am]
BILLING CODE 4160-01-F