[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR179.21]
[Page 451-452]
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
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:
(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.
(4) Machine sources producing X-radiation at energies no greater
than 10 million electron volts (MeV).
(5) Monoenergetic neutron sources producing neutrons at energies not
less than 1 MeV but no greater than 14 MeV.
(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.
[[Page 452]]
(iii) The maximum energy of X-radiation emitted by machine source.
(iv) The minimum and maximum energy of radiation emitted by neutron
source.
(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.
(iv) A statement that no food shall be exposed to a radiation source
listed in paragraph (a)(4) of this section so as to receive a dose in
excess of 0.5 gray (Gy).
(v) A statement that no food shall be exposed to a radiation source
listed in paragraph (a)(5) of this section so as to receive a dose in
excess of 0.01 gray (Gy).
[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; 66 FR 18539, Apr.
10, 2001; 69 FR 76404, Dec. 21, 2004]
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