[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: 21CFR179.21]

[Page 432-433]
 
                        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. 179.21  Sources of radiation used for inspection of food, for inspection of packaged food, and for controlling food processing.


    Sources of radiation for the purposes of inspection of foods, for 
inspection of packaged food, and for controlling food processing may be 
safely used under the following conditions:
    (a) The radiation source is one of the following:

[[Page 433]]

    (1) X-ray tubes producing X-radiation from operation of the tube 
source at a voltage of 500 kilovolt peak or lower.
    (2) Sealed units producing radiations at energy levels of not more 
than 2.2 million electron volts from one of the following isotopes: 
Americium-241, cesium-137, cobalt-60, iodine-125, krypton-85, radium-
226, and strontium-90.
    (3) Sealed units producing neutron radiation from the isotope 
Californium-252 (CAS Reg. No. 13981-17-4) to measure moisture in food.
    (b) To assure safe use of these radiation sources:
    (1) The label of the sources shall bear, in addition to the other 
information required by the Act:
    (i) Appropriate and accurate information identifying the source of 
radiation.
    (ii) The maximum energy of radiation emitted by X-ray tube sources.
    (2) The label or accompanying labeling shall bear:
    (i) Adequate directions for installation and use.
    (ii) A statement that no food shall be exposed to radiation sources 
listed in paragraph (a) (1) and (2) of this section so as to receive an 
absorbed dose in excess of 10 grays.
    (iii) A statement that no food shall be exposed to a radiation 
source listed in paragraph (a)(3) of this section so as to receive an 
absorbed dose in excess of 2 milligrays.

[42 FR 14635, Mar. 15, 1977, as amended at 48 FR 46022, Oct. 11, 1983; 
61 FR 14246, Apr. 1, 1996; 64 FR 69191, Dec. 10, 1999]