Food and Drug Administration, HHS.
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.
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.
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:
Submit electronic objections in the following way:
- Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
Submit written objections in the following ways:
- FAX: 301-827-6870.
- 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.End Further Info End Preamble Start Supplemental 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 § 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.Start Signature
Dated: March 15, 2011.
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6623 Filed 3-21-11; 8:45 am]
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