[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
