[Federal Register Volume 59, Number 164 (Thursday, August 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20985]
[[Page Unknown]]
[Federal Register: August 25, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94F-0289]
Isomedix, 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
Isomedix, Inc., has filed a petition proposing that the food additive
regulations be amended to provide for the safe use of sources of
ionizing radiation to treat the fresh or frozen raw edible tissue of
domesticated mammalian human food sources for purposes of reduction of
parasites and microbial pathogens, and extension of product shelf-life.
DATES: Written comments on the petitioner's environmental assessment by
September 26, 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: Patricia A. Hansen, Center for Food
Safety and Applied Nutrition (HFS-206), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3090.
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 4M4428) has been filed by Isomedix, Inc., 11
Apollo Dr., Whippany, NJ 07981. The petition proposes that the food
additive regulations in part 179 Irradiation in the Production,
Processing and Handling of Food (21 CFR part 179) be amended to provide
for the safe use of sources of ionizing radiation to treat the fresh or
frozen raw edible tissue of domesticated mammalian human food sources
for purposes of reduction of parasites and microbial pathogens, and
extension of product shelf-life.
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
September 26, 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 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: August 18, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-20985 Filed 8-24-94; 8:45 am]
BILLING CODE 4160-01-F
