[Federal Register Volume 66, Number 69 (Tuesday, April 10, 2001)]
[Rules and Regulations]
[Pages 18539-18540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8719]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 21 CFR Part 579

[Docket No. 99F-2799]


Irradiation in the Production, Processing, and Handling of Animal 
Feed and Pet Food; Irradiation

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to reflect approval of a food additive petition 
(FAP) filed by Sterigenics International, Inc. (now IBA Food Safety 
Division) that provides for irradiation of various animal feeds and 
feed ingredients for microbial control.

DATES: This rule is effective April 10, 2001. Submit written objections 
and request for a hearing by May 10, 2001.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: John D. McCurdy, Center for Veterinary 
Medicine (HFV-222), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0171.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of September 3, 1999 (64 FR 48409), FDA announced that a food 
additive petition (FAP 2243) had been filed by SteriGenics 
International, Inc., 4020 Clipper Ct., Fremont, CA 94538-6540. The 
petition proposed to amend the food additive regulations in part 21 CFR 
part 579 Irradiation in the Production, Processing, and Handling of 
Animal Feed and Pet Food to provide for the irradiation of various 
animal feeds and feed ingredients to control microbial contaminants. 
The notice of filing provided for a 60-day comment period. The agency 
received no comments.
    FDA has evaluated data submitted by the sponsor of the petition and 
concludes that the data establish the safety and functionality of 
irradiation for use as proposed.
    This final rule extends the ability to irradiate all animal feeds 
for the purpose of microbial disinfection, therefore, references to 
laboratory animals have been deleted from the regulation. Also, 
paragraph (b)(2) has been added to Sec. 579.22 to make clear that as 
long as an irradiated feed ingredient is less than 5 percent of the 
final product, the final product may be irradiated without conflicting 
with the statement in Sec. 579.22(b)(1) that the ionizing radiation is 
used or intended for use in single treatment.
    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 the petition are available for inspection at the 
Center for Veterinary Medicine by appointment with the information 
contact person listed above. As provided in Sec.  571.1(h), the agency 
will delete from the documents any materials that are not available for 
public disclosure before making the documents available for inspection.
    FDA has determined under 21 CFR 25.32(j) that this action is of 
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.
    Any person who will be adversely affected by this regulation may at 
any time file with the Dockets Management Branch (address above) 
written objections by May 10, 2001. 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

[[Page 18540]]

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. Three copies of all documents are to be submitted and are to 
be identified 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 Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

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

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

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

    2. Section 579.22 is amended by revising the section heading, the 
introductory paragraph, and paragraph (b) to read as follows:


Sec.  579.22  Ionizing radiation for treatment of animal diets.

    Ionizing radiation for treatment of complete diets for animals may 
be safely used under the following conditions:
* * * * *
    (b) Uses. (1) The ionizing radiation is used or intended for use in 
single treatment as follows:

------------------------------------------------------------------------
      Food for irradiation            Limitations             Use
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Bagged complete diets, packaged   Absorbed dose: Not  Microbial
 feeds, feed ingredients, bulk     to exceed 50        disinfection,
 feeds, animal treats and chews.   kiloGrays. Feeds    control or
                                   and feed            elimination
                                   ingredients
                                   treated by
                                   irradiation
                                   should be
                                   formulated to
                                   account for
                                   nutritional loss.
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    (2) If an irradiated feed ingredient is less than 5 percent of the 
final product, the final product can be irradiated without being 
considered to be re-irradiated.

    Dated: March 31, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-8719 Filed 4-9-01; 8:45 am]
BILLING CODE 4160-01-S