[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR179.25]

[Page 433]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD--Table of Contents
 
               Subpart B--Radiation and Radiation Sources
 
Sec. 179.25  General provisions for food irradiation.

    For the purposes of Sec. 179.26, current good manufacturing practice 
is defined to include the following restrictions:
    (a) Any firm that treats foods with ionizing radiation shall comply 
with the requirements of part 110 of this chapter and other applicable 
regulations.
    (b) Food treated with ionizing radiation shall receive the minimum 
radiation dose reasonably required to accomplish its intended technical 
effect and not more than the maximum dose specified by the applicable 
regulation for that use.
    (c) Packaging materials subjected to irradiation incidental to the 
radiation treatment and processing of prepackaged foods shall comply 
with Sec. 179.45.
    (d) Radiation treatment of food shall conform to a scheduled 
process. A scheduled process for food irradiation is a written procedure 
that ensures that the radiation dose range selected by the food 
irradiation processor is adequate under commercial processing conditions 
(including atmosphere and temperature) for the radiation to achieve its 
intended effect on a specific product and in a specific facility. A food 
irradiation processor shall operate with a scheduled process established 
by qualified persons having expert knowledge in radiation processing 
requirements of food and specific for that food and for that irradiation 
processor's treatment facility.
    (e) A food irradiation processor shall maintain records as specified 
in this section for a period of time that exceeds the shelf life of the 
irradiated food product by 1 year, up to a maximum of 3 years, whichever 
period is shorter, and shall make these records available for inspection 
and copy by authorized employees of the Food and Drug Administration. 
Such records shall include the food treated, lot identification, 
scheduled process, evidence of compliance with the scheduled process, 
ionizing energy source, source calibration, dosimetry, dose distribution 
in the product, and the date of irradiation.

(Approved by the Office of Management and Budget under control number 
0910-0186)

[51 FR 13399, Apr. 18, 1986]