[Federal Register Volume 72, Number 138 (Thursday, July 19, 2007)]
[Rules and Regulations]
[Pages 39560-39562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-13954]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. 1998F-0196] (Formerly 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 (FAP) in feed to provide for 
the safe use of selenium yeast as a source of supplemental selenium in 
feed supplements for limit feeding for beef cattle and in salt mineral 
mixes for free-choice feeding for beef cattle. This action is in 
response to an amendment of a food additive petition filed by Alltech, 
Inc.

DATES: This rule is effective July 19, 2007. Submit written or 
electronic objections and requests for a hearing by August 20, 2007. 
See section V of this document for information on the filing of 
objections.

ADDRESSES: You may submit written or electronic objections and requests 
for a hearing identified by Docket No. 1998F-0196, by any of the 
following methods:
Electronic Submissions
Submit electronic objections in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written objections in the following ways:
     Fax: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of objections, FDA is no longer 
accepting objections submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic objections by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.

[[Page 39561]]

    Instructions: All submissions received must include the agency name 
and docket number for this rulemaking. All objections received will be 
posted without change to http://www.fda.gov/ohrms/dockets/default.htm, 
including any personal information provided. For detailed instructions 
on submitting objections, see the ``Objections'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
objections received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Isabel W. Pocurull, Center for 
Veterinary Medicine (HFV-226), 7519 Standish Pl., Rockville, MD 20855, 
240-453-6853.

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 
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 these data were submitted for turkeys and 
swine, the selenium food additive regulation was amended to extend the 
use of selenium yeast in the complete feeds of turkeys and swine on 
July 17, 2002 (67 FR 46850). Additional data submitted by the sponsor 
and further amendments to the petition provided information to extend 
the use to beef and dairy cattle. Based on the information in the 
petition, the selenium food additive regulation was again amended to 
include the use of selenium yeast in the complete feed of beef and 
dairy cattle on September 3, 2003 (68 FR 52339). Additional data 
submitted by the sponsor and further amendments to the petition 
provided information for safe use of selenium yeast as a source of 
supplemental selenium in feed supplements for limit feeding for beef 
cattle and in salt mineral mixes for free-choice feeding for beef 
cattle. The notice of filing provided for a 60-day comment period on 
the petitioner's environmental assessment. No substantive comments have 
been received.

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 will be made available for inspection 
at the Center for Veterinary Medicine by appointment with the 
information contact person (see FOR FURTHER INFORMATION CONTACT). 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 
file with the Division of Dockets Management (see ADDRESSES) written or 
electronic objections. 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 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.

0
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

0
1. The authority citation for 21 CFR part 573 continues to read as 
follows:

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

0
2. Section 573.920 is amended by revising paragraph (h) to read as 
follows:


Sec.  573.920  Selenium.

* * * * *
    (h) Selenium yeast is a dried, non-viable 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.
    (1) Selenium, as selenium yeast, is added to feed as follows:
    (i) In complete feed for chickens, turkeys, swine, beef cattle, and 
dairy cattle at a level not to exceed 0.3 part per million.
    (ii) In feed supplements for limit feeding for beef cattle at a 
level not to exceed an intake of 3 milligrams per head per day.
    (iii) In salt-mineral mixtures for free-choice feeding for beef 
cattle up to 120 parts per million in a mixture for free-choice feeding 
at a rate not to exceed an intake of 3 milligrams per head per day.
    (2) Guaranteed organic selenium content from selenium yeast must be 
declared on the selenium yeast product label.
    (3) The additive, as selenium yeast, shall be incorporated into 
feed as follows:

[[Page 39562]]

    (i) It shall be incorporated into each ton of complete feed by 
adding no less than 1 pound of a premix containing no more than 272.4 
milligrams of added selenium per pound.
    (ii) It shall be incorporated into each ton of salt-mineral mixture 
for beef cattle from a premix containing no more than 4.5 grams of 
added selenium per pound.
    (4) Usage of this additive must conform to the requirements of 
paragraphs (e) and (f) of this section.

    Dated: July 6, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-13954 Filed 7-18-07; 8:45 am]
BILLING CODE 4160-01-S