Source: https://www.federalregister.gov/documents/2012/11/30/2012-28968/irradiation-in-the-production-processing-and-handling-of-food
Timestamp: 2017-02-20 11:11:21
Document Index: 402150738

Matched Legal Cases: ['§\u2009179', '§\u2009179', '§\u2009179', 'art 417', '§\u2009179', '§\u2009171', '§\u2009171', '§\u2009179']

A Rule by the Food and Drug Administration on 11/30/2012
71316-71321
https://www.federalregister.gov/d/2012-28968
In a notice published in the Federal Register of December 21, 1999 (64 FR 71461), FDA announced that a food additive petition (FAP 9M4696) had been filed by the USDA/FSIS, 300 12th St. SW., rm. 112, Washington, DC 20250 (currently, Food Safety and Inspection Service, Stop Code 3782, Patriots Plaza III, Cubicle 8-163A, 1400 Independence Ave. SW., Washington, DC 20250-3700). The petition proposed to amend the food additive regulation, Ionizing radiation for the treatment of food (§ 179.26 (21 CFR 179.26)) in item 6 of the table in paragraph (b) to: (1) Increase the maximum dose of ionizing radiation permitted in the treatment of poultry products; (2) include specific language intended to clarify the poultry products covered by the regulations; and (3) remove the limitation that any packaging used during irradiation of poultry shall not exclude oxygen.
FDA's current regulation under § 179.26(b)(6) permits the irradiation of fresh or frozen, uncooked poultry products that are: (1) Whole carcasses or disjointed portions of such carcasses that are “ready-to-cook poultry” within the meaning of 9 CFR 381.1(b)(44) or (2) mechanically separated poultry product (a finely comminuted ingredient produced by the mechanical deboning of poultry carcasses or parts of carcasses) up to a maximum absorbed dose of 3.0 kiloGray (kGy) with the restriction that any packaging used shall not exclude oxygen.
This amendment will bring the poultry regulation into conformity with the current regulation permitting the irradiation of refrigerated or frozen, uncooked products that are meat, meat byproducts, or meat food products; i.e., it permits a maximum absorbed dose of 4.5 kGy for non-frozen products and 7.0 kGy for frozen products (§ 179.26(b)(8)), and provides no limitation that the packaging shall not exclude oxygen, which would allow the use of packaging including modified atmosphere packaging and vacuum packaging.
a. Protein. As noted previously in this document, FDA has previously provided detailed discussions of the radiation chemistry of proteins in its rulemakings on the use of ionizing radiation to treat meat, meat byproducts, and certain meat food products (62 FR 64107 at 64110) and molluscan shellfish (70 FR 48057 at 48059-48060). Studies conducted with high-protein foods (e.g., meat, poultry, and seafood) have established that most of the radiolysis products derived from food proteins have the same amino acid composition as the original protein and are altered only in their secondary and tertiary structures (i.e., they are denatured, Ref. 2). These changes are similar to those that occur as a result of heating, but in the case of irradiation, even at doses up to 50 kGy and when food is irradiated at temperatures ranging from −168 °C to 60 °C in various studies, such changes are far less pronounced than heating and the amounts of reaction products generated are far lower (62 FR 64107 at 64110). Based on these studies, FDA concludes that there will be no significant change in the amino acid composition of poultry that is irradiated at absorbed doses not to exceed 4.5 kGy for non-frozen products and not to exceed 7.0 kGy for frozen products.
In the 1990 final rule for irradiation of poultry (55 FR 18538), FDA determined that while irradiation at a dose of 3 kGy reduces the number of many pathogenic and spoilage bacteria, it does not eliminate the relatively radiation-resistant spore-forming bacteria such as Clostridium botulinum (55 FR 18541). FDA also determined in the final rule that C. botulinum, if present, would not render fresh poultry irradiated at 3 kGy toxic before normal signs of spoilage became apparent (55 FR 18542).[1] As an extra margin of safety, however, the final rule established the limitation that packaging shall not exclude oxygen with respect to poultry, because C. botulinum does not grow in oxygenated environments (Ref. 18).
Since the final rule permitting the irradiation of poultry was published in 1990, the Agency notes that poultry production practices have changed, making C. botulinum contamination and growth less of a concern.[2] As part of the 1990 rulemaking, the Agency considered the fact that C. botulinum type E could potentially contaminate fish meal, which was typically used in chicken feed. Currently, however, fish meal has almost been completely replaced with high protein soybean and corn meal. Additionally, C. botulinum does not produce toxin when held at 10 °C (Ref. 19), and current USDA/FSIS regulations generally require that poultry plants maintain poultry at temperatures below 10 °C during processing (9 CFR 381.66(b)(1)). Finally, controlling microbiological contamination, including contamination from C. botulinum, is now required under mandatory USDA/FSIS poultry processing Hazard Analysis Critical Control Point plans (9 CFR part 417).
Based on the data and studies submitted in the petition and other information in the Agency's files, FDA concludes that the proposed use of irradiation to treat fresh (refrigerated and unrefrigerated) poultry food products [3] with absorbed doses that will not exceed 4.5 kGy and frozen poultry products not to exceed 7.0 kGy is safe with no need for a requirement that the packaging shall not exclude oxygen, and therefore, § 179.26 should be amended as set forth in this document.
In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the use of irradiation of poultry in response to the petition will be made available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person (see FOR FURTHER INFORMATION CONTACT). As provided in § 171.1(h), the Agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.
8. Crone, A.V.J., et al., “Effect of Storage and Cooking on the Dose Response of 2-Dodecylcyclobutanone, a Potential Marker for Irradiated Chicken,” Journal of the Science of Food and Agriculture, 58:249-252, 1992.
9. Gadgil, P., K.A. Hachmeister, J.S. Smith, and D.H. Kropf, “2-Alkylcyclobutanones as Irradiation Dose Indicators in Irradiated Ground Beef Patties,” Journal of Agriculture and Food Chemistry, 50:5746-5750, 2002.
12. Locas, C. and V.A. Yaylayan, “Origin and Mechanistic Pathways of Formation of the Parent Furan—a Toxicant.,” Journal of Agricultural and Food Chemistry, 52:6830-6836, 2005.
13. Fan, X., and K.J.B. Sokorai, “Effect of Ionizing Radiation on Furan Formation in Fresh-Cut Fruits and Vegetables.” Journal of Food Science. 73(2):C79-C83, 2008.
16. Underdal, B., J. Nordal, G. Lunde, and B. Eggum, “The Effect of Ionizing Radiation on the Nutritional Value of Fish (Cod) Protein,” Lebensmittel Wissenschaft Technologie, 6:90-93, 1973.
19. Firstenberg-Eden, R., D.B. Rowley, and G.E. Shattuck. “Factors Affecting Growth and Toxin Production by Clostidium Botulinum Type E on Irradiated (0.3 Mrad) Chicken Skins.” Journal of Food Protection, 47:867-870, 1982.
2. Section 179.26 is amended in the table in paragraph (b) by revising entry “6.” under the headings “Use” and “Limitations” to read as follows: § 179.26 Ionizing radiation for the treatment of food.
UseLimitations * * * * * * *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. * * * * * * *
We note that C. botulinum is not able to grow at temperatures below freezing.
We note that C. botulinum generally occurs in very low numbers in chicken.
The term “fresh poultry” is defined by USDA to include both refrigerated and unrefrigerated poultry food products.