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United States • Title 21 CFR • Part 179

Part 179PART 179—IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD

This part of the CFR outlines the regulations for the use of radiation in the production, processing, and handling of food. It specifies the types of radiation sources, their safe usage conditions, and limitations for various food treatments, including inspection, processing control, and direct treatment of food products.

What this part covers

  • Defines acceptable sources of radiation (X-ray, sealed units, machine sources, neutron sources) for food inspection and processing control.
  • Establishes conditions for the safe use of radiation sources, including labeling requirements and maximum absorbed dose limitations for different radiation types.
  • Outlines general provisions for food irradiation, emphasizing compliance with current good manufacturing practices (CGMP), minimum effective doses, and the use of scheduled processes.
  • Specifies recordkeeping requirements for food irradiation processors, including details on the treated food, lot identification, scheduled process, and dosimetry.
  • Details the types of ionizing radiation (gamma rays, electrons, X-rays) permitted for food treatment and their specific energy limitations.
  • Mandates labeling requirements for irradiated foods, including a specific logo and statement, for both packaged and non-packaged products.
  • Provides a table of specific uses for ionizing radiation in food treatment, with corresponding limitations on radiation dose for various food categories (e.g., pork, poultry, herbs, spices, shellfish).
  • Addresses the use of radiofrequency radiation (including microwave frequencies) for heating food, requiring compliance with FCC regulations.
  • Covers ultraviolet radiation for food processing and treatment, specifying lamp types and conditions for surface microorganism control and sterilization.
  • Includes regulations for pulsed light treatment of food for surface microorganism control, with limitations on pulse duration and total cumulative treatment.
  • Details the use of carbon dioxide lasers for etching information on citrus fruit surfaces, with specific energy and area limitations.
  • Specifies acceptable packaging materials that can be subjected to irradiation incidental to the treatment of prepackaged foods, with dose limitations.

Sections in Part 179

§ 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…

§ 179.25

General provisions for food irradiation.

For the purposes of § 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 parts 110 and 117 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 food shall be in compliance with § 179.45, shall be the subject of an exemption for such use under § 170.39 of this chapter, or shall be the subject of an effective premarket notification for a food contact substance for such use submitted under § 170.100 of this chapter. (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…

§ 179.26

Ionizing radiation for the treatment of food.

Ionizing radiation for treatment of foods may be safely used under the following conditions: Energy sources.(a) Ionizing radiation is limited to: (1) Gamma rays from sealed units of the radionuclides cobalt-60 or cesium-137. (2) Electrons generated from machine sources at energies not to exceed 10 million electron volts. (3) X rays generated from machine sources at energies not to exceed 5 million electron volts (MeV), except as permitted by paragraph (a)(4) of this section. (4) X rays generated from machine sources using tantalum or gold as the target material and using energies not to exceed 7.5 (MeV). Limitations.(b) Labeling.(c) (1) The label and labeling of retail packages of foods irradiated in conformance with paragraph (b) of this section shall bear the following logo along with either the statement “Treated with radiation” or the statement “Treated by irradiation” in addition to information required by other regulations. The logo shall be placed prominently and conspicuously in conjunction with the required statement. The radiation disclosure statement is not required to be more prominent than the declaration of ingredients required under § 101.4 of this chapter.…

§ 179.30

Radiofrequency radiation for the heating of food, including microwave frequencies.

Radiofrequency radiation, including microwave frequencies, may be safely used for heating food under the following conditions: (a) The radiation source consists of electronic equipment producing radio waves with specific frequencies for this purpose authorized by the Federal Communications Commission. (b) The radiation is used or intended for use in the production of heat in food wherever heat is necessary and effective in the treatment or processing of food.

§ 179.39

Ultraviolet radiation for the processing and treatment of food.

Ultraviolet radiation for the processing and treatment of food may be safely used under the following conditions: (a) The radiation sources consist of low pressure mercury lamps emitting 90 percent of the emission at a wavelength of 253.7 nanometers (2,537 Angstroms). (b) The ultraviolet radiation is used or intended for use as follows: Table | Irradiated food | Limitations | Use | | --- | --- | --- | | Food and food products | Without ozone production: high fat-content food irradiated in vacuum or in an inert atmosphere; intensity of radiation, 1 W (of 2,537 A. radiation) per 5 to 10 ft. | Surface microorganism control. | | Potable water | Without ozone production; coefficient of absorption, 0.19 per cm or less; flow rate, 100 gal/h per watt of 2,537 A. radiation; water depth, 1 cm or less; lamp-operating temperature, 36 to 46 °C. | Sterilization of water used in food production. | | Juice products | Turbulent flow through tubes with a minimum Reynolds number of 2,200. | Reduction of human pathogens and other microorganisms. | [42 FR 14635, Mar. 15, 1977, as amended at 65 FR 71057, Nov. 29, 2000]

§ 179.41

Pulsed light for the treatment of food.

Pulsed light may be safely used for treatment of foods under the following conditions: (a) The radiation sources consist of xenon flashlamps designed to emit broadband radiation consisting of wavelengths covering the range of 200 to 1,100 nanometers (nm), and operated so that the pulse duration is no longer than 2 milliseconds (msec); (b) The treatment is used for surface microorganism control; (c) Foods treated with pulsed light shall receive the minimum treatment reasonably required to accomplish the intended technical effect; and 2(d) The total cumulative treatment shall not exceed 12.0 Joules/square centimeter (J/cm .) [61 FR 42383, Aug. 15, 1996]

§ 179.43

Carbon dioxide laser for etching food.

Carbon dioxide laser light may be safely used for etching information on the surface of food under the following conditions: −3512(a) The radiation source consists of a carbon dioxide laser designed to emit pulsed infrared radiation with a wavelength of 10.6 micrometers such that the maximum energy output of the laser does not exceed 9.8 × 10 joules per square centimeter (J/cm ); (b) The carbon dioxide laser shall be used only for etching information on the skin of fresh, intact citrus fruit, providing the fruit has been adequately washed and waxed prior to laser etching, and the etched area is immediately rewaxed after treatment; and −3512(c) The maximum total energy to which the etched citrus fruit is exposed from the use of the carbon dioxide laser shall not exceed 1.5 × 10 J, and the maximum total etched surface area of the citrus fruit shall not exceed 0.122 cm . [77 FR 34215, June 11, 2012]

§ 179.45

Packaging materials for use during the irradiation of prepackaged foods.

The packaging materials identified in this section may be safely subjected to irradiation incidental to the radiation treatment and processing of prepackaged foods, subject to the provisions of this section and to the requirement that no induced radioactivity is detectable in the packaging material itself: (a) The radiation of the food itself shall comply with regulations in this part. (b) The following packaging materials may be subjected to a dose of radiation, not to exceed 10 kilograys, unless otherwise indicated, incidental to the use of gamma, electron beam, or X-radiation in the radiation treatment of prepackaged foods: (1) Nitrocellulose-coated or vinylidene chloride copolymer-coated cellophane complying with § 177.1200 of this chapter. (2) Glassine paper complying with § 176.170 of this chapter. (3) Wax-coated paperboard complying with § 176.170 of this chapter. (4) Polyolefin film prepared from one or more of the basic olefin polymers complying with § 177.1520 of this chapter. The finished film may contain: (i) Adjuvant substances used in compliance with §§ 178.3740 and 181.22 through 181.30 of this chapter, sodium citrate, sodium lauryl sulfate, polyvinyl…

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This document sits within United States CFR and is most useful when linked to operational submission, quality, and inspection workflows.

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