[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]
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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.
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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 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
