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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2018]
[CITE: 21CFR179.26]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

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

Subpart B--Radiation and Radiation Sources

Sec. 179.26 Ionizing radiation for the treatment of food.

Ionizing radiation for treatment of foods may be safely used under the following conditions:

(a) Energy sources. 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).

(b) Limitations.

Use Limitations
1. For control of Trichinella spiralis in pork carcasses or fresh, non-heat-processed cuts of pork carcassesMinimum dose 0.3 kiloGray (kGy) (30 kilorad (krad)); maximum dose not to exceed 1 kGy (100 krad).
2. For growth and maturation inhibition of fresh foodsNot to exceed 1 kGy (100 krad).
3. For disinfestation of arthropod pests in food Do.
4. For microbial disinfection of dry or dehydrated enzyme preparations (including immobilized enzymes)Not to exceed 10 kGy (1 megarad (Mrad)).
5. For microbial disinfection of the following dry or dehydrated aromatic vegetable substances when used as ingredients in small amounts solely for flavoring or aroma: culinary herbs, seeds, spices, vegetable seasonings that are used to impart flavor but that are not either represented as, or appear to be, a vegetable that is eaten for its own sake, and blends of these aromatic vegetable substances. Turmeric and paprika may also be irradiated when they are to be used as color additives. The blends may contain sodium chloride and minor amounts of dry food ingredients ordinarily used in such blendsNot to exceed 30 kGy (3 Mrad).
6. For control of food-borne pathogens in fresh (refrigerated or unrefrigerated) or frozen, uncooked poultry products that are: (1) Whole carcasses or disjointed portions (or other parts) of such carcasses that are "ready-to-cook poultry" within the meaning of 9 CFR 381.l(b) (with or without nonfluid seasoning; includes, e.g., ground poultry), or (2) mechanically separated poultry product (a finely comminuted ingredient produced by the mechanical deboning of poultry carcasses or parts of carcasses)Not to exceed 4.5 kGy for non-frozen products; not to exceed 7.0 kGy for frozen products.
7. For the sterilization of frozen, packaged meats used solely in the National Aeronautics and Space Administration space flight programsMinimum dose 44 kGy (4.4 Mrad). Packaging materials used need not comply with 179.25(c) provided that their use is otherwise permitted by applicable regulations in parts 174 through 186 of this chapter.
8. For control of foodborne pathogens in, and extension of the shelf-life of, refrigerated or frozen, uncooked products that are meat within the meaning of 9 CFR 301.2(rr), meat byproducts within the meaning of 9 CFR 301.2(tt), or meat food products within the meaning of 9 CFR 301.2(uu), with or without nonfluid seasoning, that are otherwise composed solely of intact or ground meat, meat byproducts, or both meat and meat byproductsNot to exceed 4.5 kGy maximum for refrigerated products; not to exceed 7.0 kGy maximum for frozen products.
9. For control of Salmonella in fresh shell eggs.Not to exceed 3.0 kGy.
10. For control of microbial pathogens on seeds for sprouting.Not to exceed 8.0 kGy.
11. For the control of Vibrio bacteria and other foodborne microorganisms in or on fresh or frozen molluscan shellfish.Not to exceed 5.5 kGy.
12. For control of food-borne pathogens and extension of shelf-life in fresh iceberg lettuce and fresh spinach.Not to exceed 4.0 kGy.
13. For control of foodborne pathogens, and extension of shelf-life, in unrefrigerated (as well as refrigerated) uncooked meat, meat byproducts, and certain meat food productsNot to exceed 4.5 kGy.
14. For control of food-borne pathogens in, and extension of the shelf-life of, chilled or frozen raw, cooked, or partially cooked crustaceans or dried crustaceans (water activity less than 0.85), with or without spices, minerals, inorganic salts, citrates, citric acid, and/or calcium disodium EDTANot to exceed 6.0 kGy.

(c) Labeling. (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. As used in this provision, the term "radiation disclosure statement" means the written statement that discloses that a food has been intentionally subject to irradiation.

(2) For irradiated foods not in package form, the required logo and phrase "Treated with radiation" or "Treated by irradiation" shall be displayed to the purchaser with either (i) the labeling of the bulk container plainly in view or (ii) a counter sign, card, or other appropriate device bearing the information that the product has been treated with radiation. As an alternative, each item of food may be individually labeled. In either case, the information must be prominently and conspicuously displayed to purchasers. The labeling requirement applies only to a food that has been irradiated, not to a food that merely contains an irradiated ingredient but that has not itself been irradiated.

(3) For a food, any portion of which is irradiated in conformance with paragraph (b) of this section, the label and labeling and invoices or bills of lading shall bear either the statement "Treated with radiation--do not irradiate again" or the statement "Treated by irradiation--do not irradiate again" when shipped to a food manufacturer or processor for further processing, labeling, or packing.

[51 FR 13399, Apr. 18, 1986, as amended at 53 FR 12757, Apr. 18, 1988; 53 FR 53209, Dec. 30, 1988; 54 FR 32335, Aug. 7, 1989; 55 FR 14415, Apr. 18, 1990; 55 FR 18544, May 2, 1990; 60 FR 12670, Mar. 8, 1995; 62 FR 64121, Dec. 3, 1997; 63 FR 43876, Aug. 17, 1998; 65 FR 45282, July 21, 2000; 65 FR 64607, Oct. 30, 2000; 69 FR 76846, Dec. 23, 2004; 70 FR 48072, Aug. 16, 2005; 73 FR 49603, Aug. 22, 2008; 77 FR 71316, 71321, Nov. 30, 2012; 79 FR 20779, Apr. 14, 2014]

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