[Federal Register Volume 76, Number 55 (Tuesday, March 22, 2011)]
[Notices]
[Page 15985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-6624]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1991-F-0203] (Formerly Docket No. 91F-0111)


Hartech Corporation; 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 1M4246) proposing that the food additive 
regulations be amended to provide for the safe use of a source of 
ionizing radiation to treat shellfish, including crustaceans.

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 Docket No. FDA-1991-F-0203, by any 
of the following methods:
    Electronic Submissions
    Submit electronic objections in the following way:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the 
instructions for submitting comments.
    Written Submissions
    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.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of April 16, 1991 (56 FR 15373), FDA announced that a food 
additive petition (FAP 1M4246) had been filed by Hartech Corp. 
(formerly United States Harvest Technologies, Inc., One East Chase St., 
suites 1112 and 1113, Baltimore, MD). 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 ionizing radiation to treat shellfish, including crustaceans.
    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). 
Hartech Corp. was notified of significant deficiencies in the 
information supporting its petition by letters from the Agency dated 
May 28, 1992, February 5, 1999, December 15, 2004, March 19, 2009, and 
May 22, 2009. The deficiencies related primarily to concerns about the 
possibility of Clostridium botulinum outgrowth in irradiated products, 
especially where the normal growth pattern of typical spoilage 
organisms could be changed by irradiation, thus reducing perception of 
spoilage. FDA had therefore requested information on typical spoilage 
and pathogenic microbial populations of shellfish irradiated at the 
maximum dose requested. FDA also requested additional data on the 
efficacy of the proposed doses of irradiation in reducing pathogens in 
crustaceans because the petition only included data on the efficacy of 
irradiation in reducing the levels of Vibrio species in oysters.
    Hartech Corp. has not provided information to address these 
deficiencies, and the Agency's most recent letters to Hartech Corp.'s 
last known address were returned as undeliverable. Additional efforts 
to contact this petitioner have been unsuccessful. 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 (21 U.S.C. 
348). FDA is therefore 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. 2011-6624 Filed 3-21-11; 8:45 am]
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