[Federal Register Volume 67, Number 137 (Wednesday, July 17, 2002)]
[Rules and Regulations]
[Pages 46850-46851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17959]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. 98F-0196]


Food Additives Permitted in Feed and Drinking Water of Animals; 
Selenium Yeast

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulations for food additives permitted in feed to provide for the 
safe use of selenium yeast as a source of selenium in animal feeds 
intended for turkeys and swine. This action is in response to a food 
additive petition filed by Alltech Biotechnology Center.

DATES: This rule is effective July 17, 2002. Submit written objections 
and request for hearing by September 16, 2002.

ADDRESSES: Submit written objections and requests for a hearing to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
objections to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Sharon Benz, Center for Veterinary 
Medicine (HFV-228), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-6656.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of May 12, 1998 (63 
FR 26193), FDA announced that a food additive petition (animal use) 
(FAP 2238) had been filed by Alltech Biotechnology Center, 3031 Catnip 
Hill Pike, Nicholasville, KY 40356. The petition proposed to amend the 
food additive regulations in Sec. 573.920 Selenium (21 CFR 573.920) to 
provide for the safe use of selenium yeast as a source of selenium in 
animal feeds for poultry, swine, and cattle. Based on the information 
in the petition, the selenium food additive regulation was amended to 
include the use of selenium yeast in feed for chickens on June 6, 2000 
(65 FR 35823). FDA sought additional data from the sponsor before 
approving use in other species. After this data was submitted, 
subsequent amendments to the petition provided information to extend 
its use in turkeys and swine.

II. Conclusion

    FDA concludes that the data establish the safety and utility of 
selenium yeast, for use as proposed and that the food additive 
regulations should be amended as set forth in this document.

III. Public Disclosure

    In accordance with Sec. 571.1(h) (21 CFR 571.1(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 Veterinary Medicine by appointment with the information 
contact person. As provided in Sec. 571.1(h), the agency will delete 
from the documents any materials that are not available for public 
disclosure before making the documents available for inspection.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.32(r) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

V. Objections and Hearing Requests

    Any person who will be adversely affected by this regulation may at 
any time file with the Dockets Management Branch (see ADDRESSES) 
written objections by September 16, 2002. 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 and are to 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.

[[Page 46851]]

List of Subjects in 21 CFR Part 573

    Animal feeds, Food additives.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 573 is 
amended as follows:

PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF 
ANIMALS

    1. The authority citation for 21 CFR part 573 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348.
    2. Section 573.920 is amended by revising paragraph (h) to read as 
follows:


Sec. 573.920  Selenium.

* * * * *
    (h) The additive selenium yeast is added to complete feed for 
chickens, turkeys, and swine at a level not to exceed 0.3 part per 
million. Usage of this additive must conform to the requirements of 
paragraphs (d)(1), (e), and (f) of this section.

    Dated: July 1, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-17959 Filed 7-16-02; 8:45 am]
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