[Federal Register Volume 61, Number 1 (Tuesday, January 2, 1996)]
[Rules and Regulations]
[Pages 5-6]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31556]



=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. 94F-0283]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of menadione 
nicotinamide bisulfite as a nutritional supplement for the prevention 
of vitamin K deficiency and as a source of supplemental niacin in 
chicken and turkey feed when used at a rate not to exceed 2 grams per 
ton (g/t) of complete feed. This action is in response to a food 
additive petition filed by Vanetta (U.S.A.) Inc.

DATES: Effective January 2, 1996; written objections and request for 
hearing by February 1, 1996.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Sharon A. Benz, Center for Veterinary 
Medicine (HFV-226), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1729.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 15, 1994 (59 FR 41769), FDA announced that a food 
additive petition (FAP 2228) had been filed by Vanetta (U.S.A.) Inc., 
1770 East Market St., York, PA 17402. The petition proposed to amend 
the food additives regulations in 21 CFR part 573 to provide for the 
safe use of menadione nicotinamide bisulfite as a nutritional 
supplement for the prevention of vitamin K deficiency in chickens and 
turkeys and as a source of supplemental niacin in chicken and turkey 
diets to be used at a level not to exceed 2 g/t of complete feed.
    The notice of filing provided for a 75-day comment period. No 
comments were received.
    FDA has evaluated the data and information in the petition and 
other relevant material. FDA concludes that the proposed use of the 
additive in chicken and turkey diets, not to exceed
2 g/t of complete feed, is safe. Therefore, the food additive 
regulations in part 573 are amended to add new Sec. 573.625 to reflect 
this approved use.
    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 21 CFR 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.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.
    Any person who will be adversely affected by this regulation may at 
any time on or before February 1, 1996, 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.
    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: Secs. 201, 402, 409 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348).

    2. New Sec. 573.625 is added to subpart B to read as follows:


Sec. 573.625  Menadione nicotinamide bisulfite.

    The food additive may be safely used as follows:
    (a) Product. 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) Conditions of use. As a nutritional supplement in chicken and 
turkey feeds for both the prevention of vitamin K deficiency and as a 
source of supplemental niacin.
    (c) Limitations. Not to exceed 2 grams per ton of complete feed. To 
assure safe use, the label and labeling shall bear adequate directions 
for use.


[[Page 6]]

    Dated: December 22, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Madicine.
[FR Doc. 95-31556 Filed 12-29-95; 8:45 am]
BILLING CODE 4160-01-F