[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