[Federal Register Volume 60, Number 188 (Thursday, September 28, 1995)]
[Rules and Regulations]
[Pages 50098-50099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24154]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 579

[Docket No. 92F-0317]


Food Additives; Irradiation in the Production, Processing, and 
Handling of Animal Feed and Pet Food; Ionizing Radiation for Treatment 
of Poultry Feed or Poultry Feed Ingredients

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 for irradiation in the production, processing, and 
handling of animal feed and pet food to provide for the safe use of 
gamma radiation from cobalt-60 in an absorbed dose range of 2 kiloGrays 
(kGy) (0.2 Megarads) (Mrad) to 25 kGy (2.5 Mrad), for rendering 
complete poultry feeds or poultry feed ingredients salmonella negative. 
This action is in response to a food additive petition filed by Nordion 
International, Inc.

DATES: Effective September 28, 1995; written objections and request for 
a hearing by October 30, 1995.

ADDRESSES: Submit written objections to Dockets Management Branch (HFA-
305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Sharon A. Benz, Center for Veterinary 
Medicine (HFV-226), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1724.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 20, 1992 (57 FR 37825), FDA announced that a food 
additive petition (animal use) (FAP 2216) had been filed by Nordion 
International, Inc., 447 March Rd., P.O. Box 13500, Kanata, Ontario, 
Canada K2K 1X8. The petition proposed that the feed irradiation 
regulations be amended to provide for the safe use of gamma radiation 
from cobalt-60, not to exceed 25 kGy (2.5 Mrad), to control salmonella 
in complete poultry (chickens, turkeys, ducks, geese, cornish hens, 
pheasant, and quail) feeds or feed ingredients.
    The notice of filing of FAP 2216 provided for a 60-day comment 
period. No comments have been received.
    The use of irradiation was evaluated based on its ability to render 
feed salmonella negative. Salmonella is known to cause animal disease. 
The effect of subclinical cases of salmonella on animal production is 
difficult to quantitate. There are, however, substantial circumstantial 
data suggesting a potential link between the organisms in feed and 
organisms causing human and animal salmonellosis. For this reason, in 
1990, FDA announced a goal of salmonella negative for animal feed and 
feed ingredients. FDA has defined salmonella negative as 10 samples 
testing negative for salmonella using the culture procedure described 
in the 7th edition of FDA's Bacteriological Analytical Manual (BAM).
    Data submitted by the sponsor indicate that an irradiation dose of 
1.0 kGy effectively reduces salmonella count by 1 log cycle (one 
decimal reduction). To ensure that irradiation achieves the intended 
purpose, all portions of the feed must receive at least the minimum 
absorbed dose. The minimum absorbed dose should be based on initial 
salmonella concentration using the relationship that 1 kGy reduces 
salmonella concentration by 1 log cycle. Based on the statistical power 
of the sampling plan, the minimum dose should be no less than 2 kGy in 
order to meet the salmonella negative definition.
    Data submitted by the sponsor indicates that irradiation does have 
a minimal effect on the content of some nutrients such as water soluble 
vitamins and some amino acids. Feeds treated by irradiation should be 
formulated to account for such nutritional loss.
    FDA has evaluated the data in the petition and other relevant 
material. The agency concludes that irradiation of poultry feeds and 
poultry feed ingredients is safe when the feed is formulated to allow 
for nutritional loss, and that the regulations should be amended in 
part 579 (21 CFR part 579) by adding new Sec. 579.40 as set forth 
below.
    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 21 CFR 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.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen at the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.
    Any person who will be adversely affected by this regulation may at 
any time on or before October 30, 1995 file with the Dockets Management 
Branch (address above) written objections thereto. 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 

[[Page 50099]]
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 
shall be submitted and shall 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, 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: Secs. 201, 402, 403, 409, 701 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321, 342, 343, 348, 371).

    2. New Sec. 579.40 is added to read as follows:


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

    Ionizing radiation for the treatment of complete poultry diets and 
poultry feed ingredients may be safely used as follows:
    (a) Energy sources. Ionizing radiation is limited to gamma rays 
from sealed units of cobalt-60.
    (b) Limitation. The ionizing radiation is used for feed or feed 
ingredients that do not contain drugs.
    (c) Use. Ionizing radiation is used as a single treatment for 
rendering complete poultry diets or poultry feed ingredients salmonella 
negative as follows:
    (1) Minimum dose 2.0 kiloGrays (kGy) (0.2 megarad (Mrad)); maximum 
dose 25 kGy (2.5 megarads Mrad). The absorbed dose of irradiation is to 
be based on initial concentration of salmonella using the relationship 
that 1.0 kGy (0.1 Mrad) reduces salmonella concentration by one log 
cycle (one decimal reduction).
    (2) Feeds treated by irradiation should be formulated to account 
for nutritional loss.
    (3) 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 reirradiated.

    Dated: September 21, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-24154 Filed 9-27-95; 8:45 am]
BILLING CODE 4160-01-U