[Federal Register Volume 63, Number 27 (Tuesday, February 10, 1998)]
[Notices]
[Page 6762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3296]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98F-0052]
Monsanto Co.; Filing a 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
Monsanto Co. has filed a petition proposing that the food additive
regulations be amended to provide for the safe use of L-
Phenylanlanine,N-[N-(3,3-dimethylbutyl)-L--aspartyl]-,1-methyl
ester for use as a tabletop sweetener. Monsanto Co. also proposes that
this additive be identified as neotame.
DATES: Written comments on the petitioner's environmental assessment by
March 12, 1998.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Blondell Anderson, Center for Food
Safety and Applied Nutrition (HFS-206), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3106.
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 8A4580) has been filed by Monsanto Co., 5200 Old
Orchard Rd., Skokie, IL 60077. The petition proposes to amend the food
additive regulations in 21 CFR part 172 to provide for the safe use of
L-Phenylanlanine,N-[N-(3,3-dimethylbutyl)-L- -aspartyl]-,1-
methyl ester as a tabletop sweetener and for the additive to be
identified as neotame.
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
display at the Dockets Management Branch (address above) for public
review and comment. Interested persons may, on or before March 12,
1998, 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 petitioner'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 23, 1998.
Laura M. Tarantino,
Acting Director, Office of Premarket Approval, Center for Food Safety
and Applied Nutrition.
[FR Doc. 98-3296 Filed 2-9-98; 8:45 am]
BILLING CODE 4160-01-F