[Federal Register Volume 78, Number 91 (Friday, May 10, 2013)]
[Rules and Regulations]
[Pages 27303-27304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-11147]



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 Rules and Regulations
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  Federal Register / Vol. 78, No. 91 / Friday, May 10, 2013 / Rules and 
Regulations  

[[Page 27303]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 579

[Docket No. FDA-2012-F-0178]


Irradiation in the Production, Processing, and Handling of Animal 
Feed and Pet Food; Electron Beam and X-Ray Sources for Irradiation of 
Poultry Feed and Poultry Feed Ingredients

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulations for irradiation of animal feed and pet food to provide for 
the safe use of electron beam and x-ray sources for irradiation of 
poultry feed and poultry feed ingredients. This action is in response 
to a food additive petition filed by Sadex Corp.

DATES: This rule is effective May 10, 2013. Submit either electronic or 
written objections and requests for a hearing by June 10, 2013.

ADDRESSES: You may submit either electronic or written objections and 
requests for a hearing, identified by Docket No. FDA-2012-F-0178, by 
any of the following methods:

Electronic Submissions

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

Written Submissions

    Submit written objections in the following ways:
    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.
    Instructions: All submissions received must include the Agency name 
and [Docket Number] for this rulemaking. All objections received will 
be posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
objections, see the ``Objections'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
objections received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Isabel W. Pocurull, Center for 
Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-453-6853, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of February 29, 2012 
(77 FR 12226), FDA announced that a food additive petition (animal use) 
(FAP 2272) had been filed by Sadex Corp., 2650 Murray St., Sioux City, 
IA 51111. The petition proposed to amend Title 21 of the Code of 
Federal Regulations (CFR) in part 579 Irradiation in the Production, 
Processing, and Handling of Animal Feed and Pet Food (21 CFR part 579) 
to provide for the safe use of electron beam and x-ray sources for 
irradiation of poultry feed and poultry feed ingredients. The notice of 
filing provided for a 30-day comment period on the petitioner's 
environmental assessment. One comment was received that was not 
substantive.

II. Conclusion

    FDA concludes that the data establish the safety and utility of 
electron beam and x-ray sources for use as proposed with modification 
and that the regulations for irradiation of animal feed and pet food 
should be amended as set forth in this document.

III. Public Disclosure

    In accordance with Sec.  571.1(h) (21 CFR 571.1(h)), the petition 
and the documents that FDA considered and relied upon in reaching its 
decision to approve this petition are available for inspection at the 
Center for Veterinary Medicine by appointment with the information 
contact person (see FOR FURTHER INFORMATION CONTACT). As provided in 
Sec.  571.1(h), the Agency will delete from the documents materials 
that are not available for public disclosure before making the 
documents available for inspection.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.32(j) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment, nor an environmental impact statement is required.

V. Objections and Hearing Requests

    Any person who will be adversely affected by this regulation may 
file with the Division of Dockets Management (see ADDRESSES) either 
electronic or written objections by (see DATES). Each objection shall 
be separately numbered, and each numbered objection shall specify with 
particularity the provision 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 regulation may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

[[Page 27304]]

List of Subjects in 21 CFR Part 579

    Animal feeds, Animal foods, Radiation protection.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 579 is 
amended as follows:

PART 579--IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING 
OF ANIMAL FEED AND PET FOOD

0
1. The authority citation for 21 CFR part 579 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 343, 348, 371.

0
2. In Sec.  579.40, revise paragraph (a) to read as follows:


Sec.  579.40  Ionizing radiation for the treatment of poultry feed and 
poultry feed ingredients.

* * * * *
    (a) Energy sources. Ionizing radiation is limited to:
    (1) Gamma rays from sealed units of cobalt-60 or cesium-137;
    (2) Electrons generated from machine sources at energy levels not 
to exceed 10 million electron volts;
    (3) X-rays generated from machine sources at energies not to exceed 
5 million electron volts, except as permitted by Sec.  179.26(a)(4) of 
this chapter; or
    (4) X-rays generated from machine sources using tantalum or gold as 
the target material and using energies not to exceed 7.5 (MeV).
* * * * *

    Dated: April 22, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-11147 Filed 5-9-13; 8:45 am]
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