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Proposed Rules Federal Register Vol 26706 Proposed Rules Federal Register Vol. 77, No. 88 Monday, May 7, 2012 This section of the FEDERAL REGISTER 3782, 8–163A, Washington, DC 20250– listing of the substances that have been contains notices to the public of the proposed 3700. reviewed and that have been accepted issuance of rules and regulations. The Instructions: All items submitted by as safe and suitable. purpose of these notices is to give interested mail or electronic mail must include the Prohibited Substances That May persons an opportunity to participate in the Agency name and docket number FSIS– rule making prior to the adoption of the final Conceal Damage or Inferiority— 2011–0018. Comments received in rules. Regulatory Requirements response to this docket will be made available for public inspection and The regulations that prescribe DEPARTMENT OF AGRICULTURE posted without change, including any requirements for the use of food personal information, to http:// ingredients and sources of radiation in Food Safety and Inspection Service www.regulations.gov. meat and poultry products prohibit for Docket: For access to background use in such products substances that 9 CFR Part 424 documents or comments received, go to conceal damage or inferiority or that the FSIS Docket Room at the address make the product appear better or of [Docket No. FSIS–2011–0018] listed above between 8 a.m. and 4:30 greater value (9 CFR 424.23(a)). Under the regulations, certain antimicrobial RIN 0583–AD47 p.m., Monday through Friday. FOR FURTHER INFORMATION CONTACT: substances are prohibited for use in Food Ingredients and Sources of Charles Williams, Acting Director, meat or poultry products because these Radiation Listed and Approved for Use Policy Issuances Division, Office of substances have the potential to conceal in the Production of Meat and Poultry Policy and Program Development, FSIS, damage or inferiority when used at Products U.S. Department of Agriculture, 1400 certain levels (9 CFR 424.23(a)(3)). Independence Avenue SW., Among these substances are potassium AGENCY: Food Safety and Inspection Washington, DC 20250–3700, (202) 690– sorbate, propylparaben (propyl p- Service, USDA. 2282. hydroxybenzoate), calcium propionate, sodium propionate, benzoic acid, and ACTION: Proposed rule. SUPPLEMENTARY INFORMATION: sodium benzoate. The regulations SUMMARY: The Food Safety and Background provide that these substances ‘‘* * * Inspection Service (FSIS) is proposing Under the Federal Food Drug and may be used in or on any product, only as provided in 9 CFR Chapter III’’ (9 to remove sodium benzoate, sodium Cosmetics Act (FFDCA), (21 U.S.C. 301 CFR 424.23(a)(3)). Thus, while FSIS lists propionate, and benzoic acid from the et seq.) FDA is responsible for approved uses of other substances in its list of substances that the regulations determining the safety of ingredients directive system, the Agency must prohibit for use in meat or poultry and sources of irradiation used in the codify any approved use of the products. Under this proposal, new uses production of meat and poultry substances listed in 9 CFR 424.23(a)(3) of these substances in meat or poultry products, as well as prescribing safe in the meat or poultry products products would continue to be conditions of use. Under the Federal inspection regulations. approved by the Food and Drug Meat Inspection Act (FMIA) (21 U.S.C. Administration (FDA) for safety and by 601, et seq.) and the Poultry Products Waivers of Regulatory Requirements FSIS for suitability. FSIS would add Inspection Act (PPIA) (21 U.S.C. 451 et approved uses of these substances to the The meat and poultry products seq.), FSIS is responsible for inspection regulations provide for the list of approved substances contained in determining the suitability of FDA- the Agency’s directive system. FSIS Administrator to ‘‘* * * waive for approved substances in meat and limited periods any provisions of the DATES: Comments must be received by poultry products. Pursuant to a regulations * * * to permit * * * July 6, 2012. Memorandum of Understanding (MOU) experimentation so that new ADDRESSES: FSIS invites interested that was implemented in January 2000, procedures, equipment, and/or persons to submit relevant comments on FDA and FSIS work together to evaluate processing techniques may be tested to this proposed rule. Comments may be petitions requesting the approval of new facilitate definite improvements’’ (9 CFR submitted by either of the following substances, or new uses of previously 303.1(h) and 381.3(b)). Under the methods: approved substances, for use in or on regulations, FSIS may only grant • Federal eRulemaking Portal: This meat and poultry products. The MOU is waivers from the provisions in the Web site provides the ability to type available for viewing by the public in regulations that are not in conflict with short comments directly into the the FSIS docket room and on the FSIS the purposes or provisions of the FMIA comment field on this Web page or Web site at: http://www.fsis.usda.gov/ or PPIA (9 CFR 303.1(h) and 381.3(b)). attach a file for lengthier comments. Go Regulations_&_Policies/ FSIS decides whether to grant to http://www.regulations.gov. Follow Labeling_FDA_MOU/index.asp. If an requests for waivers after considering the online instructions at that site for ingredient is approved for use in meat proposals and documentation submitted submitting comments. or poultry products, FDA establishes the by establishments to demonstrate that • Mail, including floppy disks or CD– parameters of the approved use under the use of a new technology is ROMs, and hand- or courier-delivered its regulatory system. FSIS also lists the scientifically sound; that it will items: Send to Docket Clerk, U.S. substance in FSIS Directive 7120.1, facilitate definite improvements; and Department of Agriculture (USDA), ‘‘Safe and Suitable Ingredients Used in that issuing the waiver will not conflict FSIS, OPPD, Patriots Plaza 3, 1400 the Production of Meat, Poultry, and Egg with the provisions of the FMIA or Independence Avenue SW., Mailstop Products,’’ as part of a comprehensive PPIA, i.e., the conditions of use will not VerDate Mar<15>2010 17:41 May 04, 2012 Jkt 226001 PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 E:\FR\FM\07MYP1.SGM 07MYP1 srobinson on DSK4SPTVN1PROD with PROPOSALS Federal Register / Vol. 77, No. 88 / Monday, May 7, 2012 / Proposed Rules 26707 result in an adulterated product or use. FSIS also considered each extended the companies’ regulatory product labeling that misleads petition’s supporting data on the waivers for the use of these substances consumers.1 If FSIS determines that the suitability of these substances for use in pending the conclusion of this information submitted by an meat and poultry products. From its rulemaking. initial evaluation of each petition, FSIS, establishment supports the requested Data on Suitability waiver, the Agency will waive the in consultation with FDA, concluded relevant provisions in the regulation for that the petitioners had established the To demonstrate that sodium benzoate, a limited period of time to allow the safety of sodium benzoate, sodium sodium propionate, and benzoic acid establishment to conduct an in-plant propionate, and benzoic acid at the are suitable for their intended use as trial. The purpose of the in-plant trial is proposed levels of use but that the antimicrobial agents in meat and to gather data on the effects of the use Agency needed additional data to make poultry products, Kraft submitted data of the new technology. FSIS reviews the a final suitability determination. collected from its in-plant-trials and data that are developed in the trial to Therefore, in July 2007, FSIS issued a from scientific studies that show that determine whether they show that the waiver to Kraft to conduct trials in 59 these substances do not conceal damage purpose of the waiver is being met. of its establishments on the use of or inferiority or make products appear sodium benzoate and sodium better or of greater value than they are Petitions propionate, in combination with other under the proposed conditions of use. On January 19, 2007, Kraft Foods ingredients, to control the growth of Lm Kraft submitted research findings to Global, Inc. petitioned FSIS to amend in RTE meat and poultry products. demonstrate that its proposed use of the Federal meat and poultry products Additionally, from September 2010 sodium benzoate and sodium inspection regulations to permit the use through March 2011, FSIS issued propionate is effective in controlling the of sodium benzoate and sodium waivers to various meat and poultry growth of Lm in RTE meat and poultry propionate as acceptable antimicrobial products processing establishments to products. The research took into agents that may be used in combination conduct trials on the use of account the unique composition of with other approved ingredients to antimicrobial agents containing liquid diverse products, such as hot dogs, inhibit the growth of Listeria sodium propionate and propionic acid bologna, ham, and turkey breast. Kraft monocytogens (Lm) in ready-to-eat supplied by Kemin for Lm control in developed an approach to predicting the (RTE) meat and poultry products. Kraft RTE meat and poultry products. FSIS effect of antimicrobial ingredients on requested that FSIS permit the use of granted the waivers to allow the Lm growth and confirmed the findings sodium benzoate in amounts of up to companies to gather additional data on with tests of different formulations. 0.1 percent (by weight of total product the suitability of these substances to Kraft assessed treated products for formulation) in combination with support an amendment to the quality, analyzed the nutritional approved antimicrobial agents. Kraft regulations. composition of planned formulations, requested that FSIS permit the use of As a condition of the waivers, both and considered the status of sodium sodium propionate in amounts up to 0.2 Kraft and Kemin were to track issues benzoate and sodium propionate as percent (by weight of total formulation) regarding consumer acceptance of generally recognized as safe (GRAS) in combination with approved products containing the substances at substances under FDA requirements.
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