[Federal Register Volume 61, Number 129 (Wednesday, July 3, 1996)]
[Notices]
[Page 34852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16975]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96F-0184]


Life Technologies, 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 Life 
Technologies, Inc., has filed a petition proposing that the food 
additive regulations be amended to provide for a change in the level of 
reactants for sulphopropyl cellulose ion-exchange resin for the 
recovery and purification of proteins for food use.

DATES: Written comments on the petitioner's environmental assessment by 
August 2, 1996.

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: Andrew D. Laumbach, Center for Food 
Safety and Applied Nutrition (HFS-217), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3071.

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 6A4500) has been filed by Life Technologies, 
Inc., 8400 Helgerman Ct., Gaithersburg, MD 20874. The petition proposes 
to amend the food additive regulations in Sec. 173.25 Ion-exchange 
resins (21 CFR 173.25) to provide for a change in the level of the 
reactants for sulphopropyl cellulose ion-exchange resin for the 
recovery and purification of proteins for food use. The amendment 
proposes that the amount of epichlorohydrin plus propylene oxide 
employed does not exceed 250 percent by weight of the starting quantity 
of cellulose. The current regulation provides that the amount of 
epichlorohydrin plus propylene oxide employed does not exceed 61 
percent by weight of the starting quantity of cellulose.
    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 August 2, 
1996, 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: May 31, 1996.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 96-16975 Filed 7-2-96; 8:45 am]
BILLING CODE 4160-01-F