Source: https://www.federalregister.gov/documents/2012/11/30/2012-28967/irradiation-in-the-production-processing-and-handling-of-food
Timestamp: 2018-03-22 12:57:43
Document Index: 331731439

Matched Legal Cases: ['art 179', 'art 179', '§\u2009179', '§\u2009179', '§\u2009179', '§\u2009171', '§\u2009171']

71312-71316 (5 pages)
https://www.federalregister.gov/d/2012-28967 https://www.federalregister.gov/d/2012-28967
In a notice published in the Federal Register of December 22, 1999 (64 FR 71792), FDA announced that a food additive petition (FAP 9M4695) 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 that the food additive regulations in part 179, Irradiation in the Production, Processing and Handling of Food (21 CFR part 179), be amended to provide for the safe use of a 4.5 kGy maximum dose of ionizing radiation to treat unrefrigerated (as well as refrigerated [1] ) uncooked meat, meat byproducts,[2] and certain meat food products to reduce levels of foodborne pathogens and extend shelf-life.
FDA's current regulation under § 179.26(b)(8) permits the irradiation 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 byproducts. The foods covered under § 179.26(b)(8) are subject to the Federal Meat Inspection Act (21 U.S.C. 601, et seq.), and, as described previously in this document, are defined by the USDA/FSIS in Title 9 of the Code of Federal Regulations. In this document, the term “meat” will be used to refer collectively to meat, meat byproducts, and certain meat food products applicable to this notice.
Under section 201(s) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(s)), a source of radiation used to treat food is a food additive. The additive is not added to food literally, but is rather a source of radiation used to process or treat food such that, analogous to other food processing technologies, its use can affect the characteristics of the food. Under section 409(c)(3)(A) of the FD&C Act (21 U.S.C. 348(c)(3)(A)), a food additive cannot be approved for a particular use unless a fair evaluation of the evidence establishes that the additive is safe under the conditions of that use. Importantly, the statute does not prescribe the safety tests to be performed but leaves that determination to the discretion and scientific expertise of FDA. Not all food additives require the same amount or type of testing to establish safety. The testing and data required to establish the safety of an additive will vary depending on the particular additive and its intended use.
The major components of meat are proteins and lipids and the ratios vary. Ground beef is a food defined by USDA and ranges from 5 percent to 30 percent lipids. The ratio of protein to lipid in whole cuts of beef varies depending on many factors.[3] FDA has extensively reviewed the radiation chemistry of flesh foods [4] in its rulemakings on the use of ionizing radiation to treat meat (62 FR 64107) and molluscan shellfish (70 FR 48057). In the meat rule (62 FR 64107 at 64111), FDA concluded: “In summary, the results obtained from chemical analyses of irradiated flesh foods establish that there would be very small amounts of individual radiolytic products generated by radiation doses comparable to those proposed in the petition. In addition, most of these radiolytic products are either the same as, or structurally very similar to, compounds found in foods that have not been irradiated. Because of their structural similarities to compounds found in foods that have not been irradiated, these radiolytic products would be expected to be toxicologically similar to such compounds as well. Thus, the available information regarding the radiation chemistry of the major components of flesh foods supports the proposition that there is no reason to suspect a toxicological hazard due to consumption of an irradiated flesh food.”
To summarize the previous discussions, a variety of radiolysis products derived from lipids have been identified. These include the following: Fatty acids, esters, aldehydes, ketones, alkanes, alkenes, and other hydrocarbons (Ref. 2). Identical or analogous products are found in foods that have not been irradiated. In particular, heating food produces generally the same types of products, but in amounts far greater than the trace amounts produced by irradiating food (62 FR 64107 at 64111 and references cited therein).
A class of radiolysis products that is derived from lipids, 2-alkylcyclobutanones (2-ACBs), has been reported to form in small quantities when fats are exposed to ionizing radiation. Any 2-ACB formed will depend on the fatty acid composition of the food, e.g., 2-dodecylcyclobutanone (2-DCB) is a radiation byproduct of palmitic acid (Refs. 7 and 8). In the molluscan shellfish rule, the Agency noted the reported creation of 2-DCB in irradiated chicken and ground beef, which contain triglycerides with esterified palmitic acid. FDA did not find that the presence of low levels of 2-DCB raised a safety issue (70 FR 48057 at 48060).
The Agency has determined that, although the use would be modestly different in the current petitioned request, the microbial hazards that carcasses would be subjected to would be equivalent to the microbial hazards from meat that has been further processed, i.e., meat from a completely broken-down carcass that has been refrigerated. Moreover, the same doses of irradiation would be expected to be equally effective in lowering levels of pathogenic and spoilage microorganisms.[5] Therefore, the Agency concludes, based on all the evidence before it, that irradiation of meat under the conditions set forth in the regulation presented in this document will not result in a microbiological hazard (Ref. 18).
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 provide for the safe use of a 4.5 kGy maximum dose of ionizing radiation to treat unrefrigerated (as well as refrigerated) uncooked meat, meat byproducts, and certain meat food products to reduce levels of foodborne pathogens and extend shelf-life is safe, and therefore the regulations in § 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 unrefrigerated meat 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.
FDA's review of this petition was limited to section 409 of the FD&C Act. This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, the Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amended the FD&C Act to, among other things, add section 301(ll) (21 U.S.C. 331(ll)). Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exceptions in section 301(ll)(1) to (ll)(4) of the FD&C Act applies. In our review of this petition, FDA did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to the ionizing radiation source. Accordingly, this final rule should not be construed to be a statement that ionizing radiation used to treat meat, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all food additive final rules and therefore, should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.
7. 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.
8. 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.
11. 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.
12. 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.
19. Merritt, C., Jr., P. Angelini, E. Wierbicki, and G. W. Shults, “Chemical Changes Associated With Flavor in Irradiated Meat,” Journal of Agricultural and Food Chemistry, 23:1037-1041, 1975.
2. Section 179.26 is amended in the table in paragraph (b) by adding a new entry “13.” under the headings “Use” and “Limitations” to read as follows: