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Federal Register/Vol. 78, No. 45/Thursday, March 7, 2013/Rules 14636 Federal Register / Vol. 78, No. 45 / Thursday, March 7, 2013 / Rules and Regulations products. However, FSIS will not make Done at Washington, DC, on: February 11, is responsible for determining the safety any changes to the performance 2013. of ingredients and sources of irradiation standards for these products until FSIS Alfred V. Almanza, used in the production of meat and has evaluated all comments received Administrator. poultry products, as well as prescribing and has analyzed the results of the new [FR Doc. 2013–05342 Filed 3–6–13; 8:45 am] safe conditions of use. Under the testing. BILLING CODE 3410–DM–P Federal Meat Inspection Act (FMIA) (21 U.S.C. 601, et seq.) and the Poultry USDA Nondiscrimination Statement Products Inspection Act (PPIA) (21 The U.S. Department of Agriculture DEPARTMENT OF AGRICULTURE U.S.C. 451 et seq.), FSIS is responsible (USDA) prohibits discrimination in all for determining the suitability of FDA- its programs and activities on the basis Food Safety and Inspection Service approved substances in meat and of race, color, national origin, gender, poultry products. Pursuant to a religion, age, disability, political beliefs, 9 CFR Part 424 Memorandum of Understanding (MOU) sexual orientation, and marital or family [Docket No. FSIS–2011–0018] that was implemented in January 2000, status. (Not all prohibited bases apply to FDA and FSIS work together to evaluate RIN 0583–AD47 all programs.) petitions requesting the approval of new substances, or new uses of previously Persons with disabilities who require Food Ingredients and Sources of approved substances, for use in or on alternative means for communication of Radiation Listed and Approved for Use meat and poultry products. The MOU is program information (Braille, large in the Production of Meat and Poultry available for viewing by the public in print, audiotape, etc.) should contact Products the FSIS docket room and on the FSIS USDA’s Target Center at 202–720–2600 AGENCY: Food Safety and Inspection Web site at: http://www.fsis.usda.gov/ (voice and TTY). _ _ Service, USDA. Regulations & Policies/ To file a written complaint of Labeling_FDA_MOU/index.asp. Under ACTION: Final rule. discrimination, write USDA, Office of this MOU, if FDA and FSIS approve an the Assistant Secretary for Civil Rights, SUMMARY: The Food Safety and ingredient for use in meat or poultry 1400 Independence Avenue SW., Inspection Service (FSIS) is amending products, FDA establishes the Washington, DC 20250–9410 or call the Federal meat and poultry products parameters of the approved use under 202–720–5964 (voice and TTY). USDA inspection regulations to remove its regulatory system. FSIS also lists the is an equal opportunity provider and sodium benzoate, sodium propionate, substance in FSIS Directive 7120.1, employer. and benzoic acid from the list of ‘‘Safe and Suitable Ingredients Used in the Production of Meat, Poultry, and Egg Additional Public Notification substances that the regulations prohibit for use in meat or poultry products. Products,’’ as part of a comprehensive FSIS will announce this document New uses of these substances in meat or listing of the substances that have been online through the FSIS Web page poultry products will continue to be reviewed and that have been accepted located at http://www.fsis.usda.gov/ approved by the Food and Drug as safe and suitable. (The Directive is regulations_&_policies/ Administration (FDA) for safety and by available at: http://www.fsis.usda.gov/ Federal_Register_Notices/index.asp. FSIS for suitability. FSIS will add OPPDE/rdad/FSISDirectives/ approved uses of these substances to the 7120.1.pdf.) FSIS will also make copies of this The proposed rule also explained Federal Register publication available list of approved substances contained in the Agency’s directive system. that, under FSIS’s regulations, certain through the FSIS Constituent Update, antimicrobial substances are prohibited DATES: which is used to provide information Effective May 6, 2013. for use in meat or poultry products regarding FSIS policies, procedures, FOR FURTHER INFORMATION CONTACT: because these substances have the regulations, Federal Register notices, Charles Williams, Director, Policy potential to conceal damage or FSIS public meetings, and other types of Issuances Division, Office of Policy and inferiority when used at certain levels (9 information that could affect or would Program Development, FSIS, U.S. CFR 424.23(a)(3)). Among these be of interest to constituents and Department of Agriculture, 1400 substances are potassium sorbate, stakeholders. The Update is Independence Avenue SW., propylparaben (propyl communicated via Listserv, a free Washington, DC 20250–3700, (202) 720– phydroxybenzoate), calcium propionate, electronic mail subscription service for 5627. sodium propionate, benzoic acid, and industry, trade groups, consumer SUPPLEMENTARY INFORMATION: sodium benzoate. interest groups, health professionals, In 2006, Kraft Foods Global, Inc. and other individuals who have asked Background petitioned FSIS to amend the Federal to be included. The Update is also On May 7, 2012, FSIS issued a meat and poultry products inspection available on the FSIS Web page. In proposed rule entitled ‘‘Food regulations to permit the use of sodium addition, FSIS offers an electronic mail Ingredients and Sources of Radiation benzoate and sodium propionate as subscription service which provides Listed and Approved for Use in the acceptable antimicrobial agents that automatic and customized access to Production of Meat and Poultry may be used in combination with other selected food safety news and Products’’ and requested comments on approved ingredients to inhibit the information. This service is available at the document (77 FR 26706). FSIS growth of Listeria monocytogenes (Lm) http://www.fsis.usda.gov/ proposed to remove sodium benzoate, in ready-to-eat (RTE) meat and poultry News_&_Events/Email_Subscription/. sodium propionate, and benzoic acid products. On July 26, 2010, Kemin Food Options range from recalls to export from the list of substances that the Technologies petitioned FSIS to amend information to regulations, directives, regulations prohibit for use in meat or the regulations to permit the use of and notices. Customers can add or poultry products. liquid sodium propionate and liquid delete subscriptions themselves, and As explained in the proposal, under sodium benzoate as acceptable have the option to password protect the Federal Food Drug and Cosmetics antimicrobial agents in meat and their accounts. Act (FFDCA)(21 U.S.C. 301 et seq.), FDA poultry products. VerDate Mar<15>2010 14:39 Mar 06, 2013 Jkt 229001 PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 E:\FR\FM\07MRR1.SGM 07MRR1 emcdonald on DSK67QTVN1PROD with RULES Federal Register / Vol. 78, No. 45 / Thursday, March 7, 2013 / Rules and Regulations 14637 After receiving each petition, FSIS under the conditions proposed in the maximum level for the combination conducted an initial evaluation of the petitions, are both safe and suitable for cannot exceed 0.1 percent (in requested action to confirm that FDA use as antimicrobial agents in certain accordance with 21 CFR 184.1(d)). FSIS had no objections to the safety of RTE meat and poultry products. will include this information in the sodium benzoate, sodium propionate, or Therefore, FSIS is amending 9 CFR directive. benzoic acid at the proposed levels of 424.23(a)(3) to remove these substances As a result of amending 9 CFR use. FSIS also considered each from the list of prohibited substances 424.23(a)(3), the procedures for listing petitioner’s supporting data on the that may be used ‘‘* * * in or on any approved uses of sodium propionate, suitability of these substances for use in product, only as provided in 9 CFR benzoic acid, and sodium benzoate in meat and poultry products. FSIS Chapter III.’’ the FSIS directive will be consistent concluded that the petitioners had Under this final rule, use of these with the procedures for listing approved established the safety of sodium substances in or on meat or poultry uses in meat and poultry products of benzoate, sodium propionate, and products will continue to be approved other safe and suitable substances. benzoic acid at the proposed levels of by FDA for safety and by FSIS for Approved new uses of potassium use but that the Agency needed suitability. FDA will continue to sorbate, propylparaben (propyl p- additional data to make a final establish the parameters of the approved hydroxybenzoate), and calcium suitability determination. Therefore, in use under its regulatory system, and propionate will continue to be listed July 2007, FSIS issued a waiver of FSIS will list approved uses of these through rulemaking because the provisions under 9 CFR 303.1(h) and substances in the table of approved regulations (9 CFR 424.23(a)(3)) prohibit 381.3(b) to enable Kraft to conduct substances in Directive 7120.1. In that their use in meat and poultry products. various experimental trials involving directive, FSIS will specify that sodium FSIS carefully considered all the the use of sodium benzoate and sodium propionate (generally recognized as safe comments received and developed the propionate, in combination with other under 21 CFR 184.1784) can be used as following responses. ingredients, to control the growth of Lm an antimicrobial in various meat and in RTE meat and poultry products. poultry products in an amount not to Discussion of Comments Additionally, from September 2010 exceed 0.5 percent (by weight of total FSIS received 20 comments in through March 2011, FSIS issued formulation) when used alone. Sodium response to the proposed rule. Members waivers to Kemin and to various meat propionate is a direct food ingredient of the public submitted twelve, and poultry product processing that must be labeled by its common or organizations related to the food establishments to conduct trials on the usual name in the ingredients statement industry five, and a food safety use of antimicrobial agents containing of a product (21 CFR 101.4, 9 CFR consulting firm, a non-profit liquid sodium propionate and propionic 317.2(f), 381.118(a)).
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