[Federal Register Volume 68, Number 99 (Thursday, May 22, 2003)]
[Rules and Regulations]
[Page 27904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12785]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. 02F-0327]


Food Additive Permitted in Feed and Drinking Water of Animals; 
Feed-Grade Biuret

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 to provide for the safe use of feed-
grade biuret in lactating dairy cattle feed. This action is in response 
to a food additive petition filed by ADM Alliance Nutrition, Inc.

DATES: This rule is effective May 22, 2003; written objections and 
request for hearing should be submitted by July 23, 2003.

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: 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 August 28, 2002 
(67 FR 55269), FDA announced that a food additive petition (FAP 2248) 
had been filed by ADM Alliance Nutrition, Inc., 1000 North 30th St., 
P.O. Box C1., Quincy, IL 62305-7100. The petition proposed to amend the 
food additive regulations in Part 573 Food Additives Permitted in Feed 
and Drinking Water of Animals (21 CFR part 573) to provide for the use 
of feed grade biuret in the diets of lactating dairy cows. The notice 
of filing provided for a 75-day comment period on the petitioner's 
environmental information. No substantive comments have been received.

II. Conclusion

    FDA has evaluated data submitted by the sponsor of the petition and 
concludes that the data establish the safety and functionality of feed-
grade biuret for use as proposed.

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 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 on or before July 23, 2003, file with the Dockets Management 
Branch (address above) written objections thereto. 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 shall be 
submitted and shall 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.

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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

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

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


Sec.  573.220  Feed-grade biuret.

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2. Section 573.220 Feed-grade biuret is amended by removing paragraph 
(c)(1)(iii).

    Dated: May 14, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-12785 Filed 5-21-03; 8:45 am]
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