21 CFR 179.21 - Sources of radiation used for inspection of food, for inspection of packaged food, and for controlling food processing.

prev | next
§ 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.
(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]
Beta! The text on the eCFR tab represents the unofficial eCFR text at ecfr.gov.
§ 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.

(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]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 179 after this date.

  • 2015-11-18; vol. 80 # 222 - Wednesday, November 18, 2015
    1. 80 FR 71934 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Clarification of Compliance Date for Certain Food Establishments
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; clarification of compliance date for certain food establishments.
      The compliance date under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (published on September 17, 2015 at 80 FR 55908) for grade “A” milk and milk products covered by NCIMS under the PMO is September 17, 2018.
      21 CFR Parts 1, 11, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211