[Federal Register Volume 64, Number 25 (Monday, February 8, 1999)]
[Notices]
[Page 6100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2851]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99F-0187]


Monsanto Co.: 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 
Monsanto Co. has filed a petition proposing that the food additive 
regulations be amended to provide for the safe use of L-Phenylalanine, 
N-[N-(3,3-dimethylbutyl)-L--aspartyl]-,1-methyl ester as a 
general use sweetener. Monsanto proposes that this additive be 
identified as neotame.

DATES: Written comments on the petitioner's environmental assessment by 
April 10, 1999.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

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 9A4643) has been filed by Monsanto Co., 5200 Old 
Orchard Rd., Skokie, IL 60077. The petition proposes to amend the food 
additive regulations in part 172 Food Additives Permitted for Direct 
Addition to Food for Human Consumption to provide for the safe use of 
N-[N-(3,3-dimethylbutyl)-L--aspartyl]-L-phenylalanine 1-methyl 
ester as a general use sweetener. Monsanto proposes the sweetener 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 April 10, 
1999, 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 28, 1999.
 Laura M. Tarantino,
 Acting Director, Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 99-2851 Filed 2-5-99; 8:45 am]
BILLING CODE 4160-01-F