[Federal Register Volume 63, Number 202 (Tuesday, October 20, 1998)]
[Rules and Regulations]
[Pages 55945-55946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28060]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 98F-0390]
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 2,9-
dimethylanthra(2,1,9-def:6,5,10-d'e'f')diisoquinoline-1,3,8,10(2H,9H)-
tetrone, (C.I. Pigment Red 179) as a colorant for all polymers intended
for use in contact with food. This action responds to a petition filed
by BASF Corp.
DATES: This regulation is effective October 20, 1998; written
objections and requests for a hearing by November 19, 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 June 15, 1998 (63 FR 32672), FDA announced that a food
additive petition (FAP 8B4596) 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 2,9-
dimethylanthra(2,1,9-def:6,5,10-d'e'f')diisoquinoline-1,3,8,10-(2H,9H)-
tetrone, (C.I. Pigment Red 179) 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 previously considered the environmental effects of
this rule as announced in the notice of filing for FAP 8B4596 (63 FR
32672, June 15, 1998). 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 November 19, 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.
[[Page 55946]]
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) * * *
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Substances Limitations
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* * * * * *
*
2,9-Dimethylanthra(2,1,9-def:6,5,10- For use at levels not to exceed 1 percent by weight of
d'e'f')diisoquinoline-1,3,8,10(2H,9H)-tetrone (C.I. polymers. The finished articles are to contact food
Pigment Red 179, CAS Reg. No. 5521-31-3). only under conditions of use B through H as described
in Table 2 of Sec. 176.170(c) of this chapter.
* * * * * *
*
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Dated: October 9, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 98-28060 Filed 10-19-98; 8:45 am]
BILLING CODE 4160-01-F
