[Federal Register Volume 60, Number 156 (Monday, August 14, 1995)]
[Rules and Regulations]
[Pages 41804-41805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19946]



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[[Page 41805]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. 87C-0316]


Listing of Color Additives Exempt From Certification; 
Astaxanthin; Objection and Request for a Hearing; Staying Portions of 
the Regulation; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
has received one objection to the final rule for astaxanthin as a color 
additive in the feed of salmonid fish to enhance the color of their 
flesh. The objection concerns a specification and the requirement for 
labeling of the color additive. The objection requests a hearing on the 
two issues. The submission of the objection stays the effective date of 
two paragraphs of the astaxanthin regulation until the agency can rule 
on them. FDA is confirming the effective date of May 16, 1995, for the 
remainder of this regulation that appeared in the Federal Register of 
April 13, 1995 (60 FR 18736).

DATES: Effective date confirmed: May 16, 1995, except for 21 CFR 
73.35(b) for the specification for total carotenoids other than 
astaxanthin and 21 CFR 73.35(d)(3) for the labeling requirements.

FOR FURTHER INFORMATION CONTACT: James C. Wallwork, Center for Food 
Safety and Applied Nutrition (HFS-217), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204-0001, 202-418-3078.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 13, 1995 
(60 FR 18736), FDA amended part 73 (21 CFR part 73) of its regulations 
to provide for the safe use of astaxanthin as a color additive in the 
feed of salmonid fish to enhance the color of their flesh.
     FDA gave interested persons until May 15, 1995, to file objections 
and requests for a hearing on Sec. 73.35 (21 CFR 73.35). The agency 
received from one color additive manufacturer objections to two 
provisions of the final rule. The objector requested a hearing on two 
issues: The specification for total carotenoids other than astaxanthin 
of not more than 4 percent under Sec. 73.35(b) and the labeling 
requirement for the presence of the color additive in salmonid fish 
under Sec. 73.35(d)(3). Under section 701(e)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 371(e)(2)) the objection stays the 
effect of these two paragraphs of the astaxanthin regulation until the 
agency has ruled on the objections. Apart from Sec. 73.35(b) and 
(d)(3), FDA is confirming the effective date of May 16, 1995, for the 
final rule that amended the color additive regulations to provide for 
the use of astaxanthin as a color additive in the feed of salmonid fish 
to enhance the color of their flesh. The objections are on file in the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857, under the docket number 
found in the heading of this document.

List of Subjects in 21 CFR Part 73

     Color additives, Cosmetics, Drugs, Medical devices.
     Therefore, under the Federal Food, Drug, and Cosmetic Act (secs. 
201, 401, 402, 403, 409, 501, 502, 505, 601, 602, 701, 721 (21 U.S.C. 
321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e)) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 
5.10), notice is given that because of the objection and request for a 
hearing on the specification for total carotenoids other than 
astaxanthin of not more than 4 percent in Sec. 73.35(b) and the 
labeling requirement for the presence of the color additive in salmonid 
fish in Sec. 73.35(d)(3), these provisions are stayed until further 
notice. Accordingly, the amendments to Sec. 73.35 issued on April 13, 
1995 (60 FR 18736), became effective May 16, 1995, except for 
Secs. 73.35(b) and (d)(3), which are stayed until further notice.

    Dated: August 7, 1995.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 95-19946 Filed 8-11-95; 8:45 am]
BILLING CODE 4160-01-F