[Federal Register Volume 65, Number 109 (Tuesday, June 6, 2000)]
[Rules and Regulations]
[Pages 35823-35824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14214]


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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 chickens. This action is in response to a food additive 
petition filed by Alltech Biotechnology Center.

DATES: This rule is effective June 6, 2000. Submit written objections 
and requests for a hearing by July 6, 2000.

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: Nelson Chou, Center for Veterinary 
Medicine (HFV-228), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0161.

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 intended for use in poultry. The notice of filing provided 
for a 60-day comment period on the petitioner's environmental 
assessment. No comments have been received.

II. Conclusion

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

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 listed above. 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

[[Page 35824]]

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 (address above) 
written objections by July 6, 2000. 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.

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 (b) and by 
adding paragraph (h) to read as follows:


Sec. 573.920  Selenium.

* * * * *
    (b) The food additive selenium is a nutrient administered in animal 
feed as sodium selenite or sodium selenate or in a controlled-release 
sodium selenite bolus, as provided in paragraphs (f) and (g) of this 
section, or as selenium yeast, as provided in paragraph (h) of this 
section.
* * * * *
    (h) The additive selenium yeast is added to complete feed for 
chickens at a level not to exceed 0.3 part per million. Usage of this 
additive must conform to the requirements of paragraphs (e) and (f) of 
this section.

    Dated: May 26, 2000.
Andrew A. Beaulieu,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 00-14214 Filed 6-5-00; 8:45 am]
BILLING CODE 4160-01-F