[Federal Register Volume 59, Number 14 (Friday, January 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1424]
[[Page Unknown]]
[Federal Register: January 21, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93F-0461]
Novo Nordisk Bioindustrials, Inc.; Filing of Food Additive
Petition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that Novo
Nordisk Bioindustrials, Inc., has filed a petition proposing that the
food additive regulations be amended to provide for the safe use of
aspartic proteinase enzyme preparation produced by pure culture
fermentation of a strain of Aspergillus oryzae modified by recombinant
deoxyribonucleic acid (DNA) techniques to contain the gene for aspartic
proteinase enzyme from Rhizomucor miehei for use in the production of
cheese.
DATES: Written comments on the petitioner's environmental assessment by
February 22, 1994.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Dennis M. Keefe, Center for Food
Safety and Applied Nutrition (HFS-206), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-254-9523.
SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic
Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food
additive petition (FAP 4A4406) has been filed by Novo Nordisk
Bioindustrials, Inc., 33 Turner Rd., P.O. Box 1907, Danbury, CT 06813-
1907. The petition proposes to amend the food additive regulations to
provide for the safe use of aspartic proteinase enzyme preparation
produced by pure culture fermentation of a strain of A. oryzae modified
by recombinant DNA techniques to contain the gene for aspartic
proteinase enzyme from R. miehei for use in the production of cheese.
The potential environmental impact of this action is being
reviewed. To encourage public participation consistent with regulations
promulgated under the National Environmental Policy Act (40 CFR
1501.4(b)), the agency is placing the environmental assessment
submitted with the petition that is the subject of this notice on
public display at the Dockets Management Branch (address above) for
public review and comment. Interested persons may, on or before
February 22, 1994, submit to the Dockets Management Branch (address
above) written comments. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday. FDA will also place
on public display any amendments to, or comments on, the petitioners's
environmental assessment without further announcement in the Federal
Register. If, based on its review, the agency finds that an
environmental impact statement is not required and this petition
results in a regulation, the notice of availability of the agency's
finding of no significant impact and the evidence supporting that
finding will be published with the regulation in the Federal Register
in accordance with 21 CFR 25.40(c).
Dated: January 11, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-1424 Filed 1-19-94; 4:15 pm]
BILLING CODE 4160-01-F
