[Federal Register: April 10, 2001 (Volume 66, Number 69)]
[Rules and Regulations]
[Page 18539-18540]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ap01-14]
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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:
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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