[Federal Register Volume 64, Number 166 (Friday, August 27, 1999)]
[Rules and Regulations]
[Page 46840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22313]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. 98F-0195]


Food Additives Permitted in the Feed and Drinking Water of 
Animals; Menadione Nicotinamide Bisulfite

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of menadione 
nicotinamide bisulfite (MNB) in diets of growing and finishing swine as 
a nutritional supplement for the prevention of vitamin K deficiency and 
as a source of supplemental niacin. This action is in response to a 
food additive petition (animal use) filed by Vanetta S.p.A.

DATES: The regulation is effective August 27, 1999; submit written 
objections and requests for a hearing by September 27, 1999.

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:  Michaela G. Alewynse, Center for 
Veterinary Medicine (HFV-228), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6657.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of May 12, 1998 (63 FR 26194), FDA announced that a food 
additive petition (animal use) (FAP 2239) had been filed by Vanetta 
S.p.A., Via Alzia Trento 10, Milano, Corsico, Italy. The petition 
proposed to amend the food additives regulations in part 573 (21 CFR 
part 573) to provide for use of menadione nicotinamide bisulfite in 
swine diets as a source of vitamin K activity and niacin. The notice of 
filing provided that written comments be sent to the Dockets Management 
Branch. No comments were received.
    The agency has evaluated the information submitted by the sponsor 
in support of the petition and other relevant material and concluded 
that it establishes the safety and utility of up to 10 grams MNB per 
ton of complete feed in the diets of growing and finishing swine as a 
nutritional supplement for the prevention of vitamin K deficiency and 
as a source of supplemental niacin. Therefore, Sec. 573.625 is amended 
to provide for this use. Furthermore, the section is revised to conform 
to current format.
    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), FDA will 
delete from the documents any materials that are not available for 
public disclosure before making the documents available for inspection.
    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.
    Any person who will be adversely affected by this regulation may at 
any time on or before September 27, 1999, file with the Dockets 
Management Branch (see 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.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 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 573.625 is revised to read as follows:


Sec. 573.625  Menadione nicotinamide bisulfite.

    The food additive may be safely used as follows:
    (a) The additive is 1,2,3,4-tetrahydro-2-methyl-1,4-dioxo-2-
naphthalene sulfonic acid with 3-pyridine carboxylic acid amine (CAS 
No. 73581-79-0).
    (b) The additive is used or intended for use as a nutritional 
supplement for both the prevention of vitamin K deficiency and as a 
source of supplemental niacin as follows:
    (1) In chicken and turkey feeds at a level not to exceed 2 grams 
per ton of complete feed.
    (2) In growing and finishing swine feeds at a level not to exceed 
10 grams per ton of complete feed.
    (c) To assure safe use, the label and labeling of the additive 
shall bear adequate directions for use.

    Dated: August 2, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-22313 Filed 8-26-99; 8:45 am]
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