[Federal Register Volume 76, Number 55 (Tuesday, March 22, 2011)]
[Notices]
[Page 15986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-6623]



[[Page 15986]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1990-F-0390] (Formerly Docket No. 90F-0074)


Alpha Omega Technology, Inc.; Denial Without Prejudice of Food 
Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is denying a food 
additive petition (FAP 0M4181) proposing that the food additive 
regulations be amended to provide for the safe use of a source of 
irradiation to treat shellfish and finfish.

DATES: This order is effective June 20, 2011; except as to any 
provisions that may be stayed by the filing of proper objections. 
Submit either electronic or written objections and requests for a 
hearing by April 21, 2011.

ADDRESSES: You may submit either electronic or written objections and 
requests for a hearing, identified by FDA-1990-F-0390, by any of the 
following methods:

Electronic Submissions

    Submit electronic objections in the following way:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written objections in the following ways:
    <bullet> FAX: 301-827-6870.
    <bullet> Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Richard E. Bonnette, Center for Food 
Safety and Applied Nutrition (HFS-255), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1235.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of March 15, 1990 (55 FR 9772), FDA announced that a food 
additive petition (FAP 0M4181) had been filed by Alpha Omega 
Technology, Inc., 1279 Route 46 East, Parsippany, NJ 07054. The 
petition proposed to amend the food additive regulations in Sec.  
179.26 Ionizing radiation for the treatment of food (21 CFR 179.26) to 
provide for the safe use of a source of irradiation to treat finfish 
and shellfish.
    For any food additive petition, the burden is on the petitioner to 
submit to FDA data and information that are adequate for the Agency to 
determine that the proposed use of the additive under the specified 
conditions of use is safe (21 U.S.C. 348(c)(3)(A); 21 CFR 171.1). Alpha 
Omega Technology, Inc., was informed of significant deficiencies in its 
petition by letters from FDA dated May 28, 1992, September 15, 1993, 
February 10, 1999, July 20, 2004, March 19, 2009, and May 22, 2009. The 
deficiencies related primarily to the possibility of Clostridium 
botulinum outgrowth in packaged products, especially where the normal 
growth pattern of typical spoilage organisms could be changed by 
irradiation, thus reducing perception of spoilage.
    FDA noted that the data provided in the petition indicated that 
there was very little margin of safety with regard to the concern for 
C. botulinum outgrowth and toxin elaboration, particularly in 
irradiated fish stored at temperatures between 46 and 50 degrees 
Fahrenheit. FDA therefore requested data demonstrating that products 
irradiated at the maximum dose requested and subjected to some 
temperature abuse would show evidence of spoilage before showing 
evidence of toxicity.
    Alpha Omega Technology, Inc., has been unresponsive to these 
requests, and other efforts to contact the petitioner regarding the 
petition have not been successful. The petitioner has not provided 
sufficient data and information for the Agency to conclude that the 
proposed use of the food additive is safe in accordance with section 
409 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 
U.S.C. 348). Consequently, FDA is denying the petition without 
prejudice to a future filing (21 U.S.C. 348(c)(1)(B), 21 CFR 
171.100(a)).
    This order is effective as shown in the DATES section of this 
document; except as to any provisions that may be stayed by the filing 
of proper objections. Any person who will be adversely affected by this 
order may file with the Division of Dockets Management (see ADDRESSES) 
either electronic or written objections. Each objection shall be 
separately numbered, and each numbered objection shall specify with 
particularity the provisions of the regulation to which objection is 
made and the grounds for the objection. Each numbered objection on 
which a hearing is requested shall specifically so state. Failure to 
request a hearing for any particular objection shall constitute a 
waiver of the right to a hearing on that objection. Each numbered 
objection for which a hearing is requested shall include a detailed 
description and analysis of the specific factual information intended 
to be presented in support of the objection in the event that a hearing 
is held. Failure to include such a description and analysis for any 
particular objection shall constitute a waiver of the right to a 
hearing on the objection. It is only necessary to send one set of 
documents. It is no longer necessary to send three copies of all 
documents. Identify documents with the docket number found in brackets 
in the heading of this document. Any objections received in response to 
the order may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday. FDA will publish notice of the 
objections that the Agency has received or lack thereof in the Federal 
Register.

    Dated: March 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6623 Filed 3-21-11; 8:45 am]
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