[Federal Register: September 3, 2003 (Volume 68, Number 170)]
[Rules and Regulations]               
[Page 52339-52340]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

21 CFR Part 573

[Docket No. 1998F-0196]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.


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 for 
beef and dairy cattle and to provide a description of the food 
additive. This action is in response to a food additive petition filed 
by Alltech Biotechnology Center.

DATES: This rule is effective September 3, 2003. Submit written 
objections and request for hearing by November 3, 2003.

ADDRESSES: Submit written objections and requests for a hearing to the 
Division of Dockets Management (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.


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 for 
turkeys and swine, the selenium food additive regulation was amended to 
extend its use in turkeys and swine on July 17, 2002 (67 FR 46850). 
Additional data submitted by the sponsor and further amendments to the 
petition provide information to extend its use to beef and dairy 
cattle. The notice of filing provided for a 60-day comment period on 
the petitioner's environmental assessment. No substantive comments have 
been received.
    In the regulation in Sec.  571.1(c) (21 CFR 571.1(c)), paragraph E 
of the form for petitions requires full reports of investigations of 
the safety of a food additive. The Center for Veterinary Medicine (CVM) 
evaluated information in the petition and in the scientific literature 
and has determined that there is an acceptable daily intake of 0.4 
milligram (mg) per person per day for selenium in the human diet. It 
has further determined that when supplemental selenium is incorporated 
at the maximal allowable levels of 0.3 part per million (ppm) of 
complete feeds, selenium levels in edible animal products are at or 
below the upper limit of the normal range of selenium in untreated 
animals. These upper limits are as follows: Swine, 0.8 ppm in muscle 
and 1.1 ppm in liver, and dairy cattle (milk) 0.14 ppm. Further, CVM 
considers the normal range for selenium in beef (liver) is 0.1 to 1.2 
ppm; turkeys, 0.6 ppm in muscle and 1.4 ppm in liver; for chicken 
(liver) 0.1 to 0.9 ppm and for eggs 0.1 to 0.5 ppm.

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), 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.

[[Page 52340]]

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 
file with the Division of Dockets Management (see ADDRESSES) written 
objections by (see DATES). Each objection must be separately numbered, 
and each numbered objection must 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 must state that a hearing is requested. Failure to request a 
hearing for any particular objection will constitute a waiver of the 
right to a hearing on that objection. Each numbered objection for which 
a hearing is requested must 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 
will constitute a waiver of the right to a hearing on the objection. 
Three copies of all documents must be submitted and must 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 Division of Dockets Management 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:


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

    Authority: 21 U.S.C. 321, 342, 348.

2. Section 573.920 is amended by revising paragraph (h) to read as 

Sec.  573.920  Selenium.

* * * * *
    (h) The additive selenium yeast is added to complete feed for 
chickens, turkeys, swine, beef cattle and dairy cattle at a level not 
to exceed 0.3 part per million.
    (1) Selenium yeast is a dried, nonviable yeast (Saccharomyces 
cerevisiae) cultivated in a fed-batch fermentation which provides 
incremental amounts of cane molasses and selenium salts in a manner 
which minimizes the detrimental effects of selenium salts on the growth 
rate of the yeast and allows for optimal incorporation of inorganic 
selenium into cellular organic material. Residual inorganic selenium is 
eliminated in a rigorous washing process and must not exceed 2 percent 
of the total selenium content in the final selenium yeast product.
    (2) Guaranteed organic selenium content from selenium yeast must be 
declared on the selenium yeast product label.
    (3) Usage of this additive must conform to the requirements of 
paragraphs (d)(1), (e), and (f) of this section.

    Dated: August 19, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-22358 Filed 9-2-03; 8:45 am]