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 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, , and ACTION: Proposed rule. SUPPLEMENTARY INFORMATION: . 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

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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 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. antimicrobial agents and adjuvants. issue during the trial period and to Kraft’s research demonstrated that On July 26, 2010, Kemin Food identify any situations that resulted in differences in product composition, Technologies petitioned FSIS to amend consumer concerns about the products. especially moisture, can influence the regulations to permit the use of The waivers also provided that both antimicrobial activity and formulation companies were to collect data to show liquid sodium propionate and liquid needs. From its study, Kraft determined that normal spoilage indicators are not sodium benzoate as acceptable that the following formulations for the masked in products treated with the antimicrobial agents in meat and antimicrobial ingredients are effective in substances, that nutrients are not poultry products. Kemin requested that controlling the growth of Lm: adversely affected, and that product (1) A combination of 0.1 percent FSIS approve the use of liquid sodium appearance (e.g., color) did not change sodium benzoate and 0.1 percent propionate to inhibit microbial growth when compared with untreated sodium diacetate in some lower in various meat and poultry products in products. Another condition of the moisture products such as hot dogs; amounts of up to 0.5 percent by weight waivers was that the meat and poultry (2) A combination of 0.1 percent of total product formulation. Kemin also products formulated with the subject sodium benzoate, 0.15 percent sodium requested that FSIS approve the use of ingredients have an approved label that diacetate, and 0.2 percent sodium liquid sodium propionate and sodium includes an accurate declaration of the propionate in high moisture products benzoate to prohibit microbial growth in ingredients in the appropriate order of such as ham; and various meat and poultry products in predominance. (3) A combination of 0.1 percent amounts of up to 0.4 percent by weight While operating under the waivers, sodium benzoate, 0.15 percent sodium of total formulation, whereas liquid both companies gathered sufficient data diacetate, 0.2 percent sodium sodium benzoate will not exceed 0.1 to support the use of sodium propionate, and 0.56 percent Lem-O- percent of product formulation. propionate, sodium benzoate, and Fos® in turkey. After receiving each petition, FSIS benzoic acid as antimicrobial agents in In addition, Kraft submitted three conducted an initial evaluation of the RTE meat and poultry products. studies to address concerns about the requested action to confirm that FDA Accordingly, FSIS is initiating this potential use of the substances to had no objections to the safety of rulemaking proposing to remove these conceal damage or mask inferiority. sodium benzoate, sodium propionate, or substances from the list of substances First, Kraft assessed whether the benzoic acid at the proposed levels of prohibited for use in meat or poultry proposed uses of sodium benzoate and products. Should FSIS finalize this sodium propionate would affect normal 1 For Agency New Technology waiver procedures, see http://www.fsis.usda.gov/ proposed rule, the Agency will list indicators of spoilage. The results of two Regulations_&_Policies/New_Technologies/ approved uses of these substances in shelf life studies on the spoilage issue index.asp. FSIS Directive 7120.1. FSIS has showed that there was very little

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difference in spoilage characteristics products. The studies compared (propyl p-hydroxybenzoate), and among products formulated with the products containing Kemin’s calcium propionate from the list of antimicrobial treatments being antimicrobial treatments at use rates of prohibited substances in 9 CFR evaluated and products formulated 0.3, 0.4, and 0.5 percent sodium 424.23(a)(3) because the petitions did without antimicrobials. Second, Kraft propionate alone, or 0.4 percent when not include data on the use of these conducted a nutritional composition combined with sodium benzoate, with substances in meat or poultry products. test for moisture, protein, fat, ash, and an untreated control or a product Therefore, if this proposed rule is sodium content. Other than a reduction containing the current industry standard finalized, approved new uses of in ash and an increase in moisture as lactate. The studies showed that, potassium sorbate, propylparaben lactate solids are replaced by water, the although growth of spoilage (propyl p-hydroxybenzoate), and study found no differences in microorganisms was significantly calcium propionate would continue to nutritional composition between different in products from replicate be listed through rulemaking. FSIS products treated with the substances trials, the competitive microflora did requests comments and supporting data and untreated products. Finally, Kraft not appear to have been affected by on whether the Agency should remove evaluated the efficacy and spoilage Kemin’s antimicrobial substances, and any of these substances from 9 CFR characteristics of sodium benzoate and normal spoilage indicators were not 424.23(a)(3) and list their approved new sodium propionate in vacuum disguised. In addition, Kemin submitted uses in FSIS Directive 7120.1. packaging or modified atmosphere data to demonstrate that proposed uses Executive Order 12866, Executive packaging with nitrogen and carbon of liquid sodium propionate alone or in Order 13563, and Regulatory Flexibility dioxide and found that the type of a blend with sodium benzoate do not Act packaging did not have a technical negatively affect color, texture and other effect on the efficacy and spoilage sensory attributes, nutritional profile, or Executive Orders 13563 and 12866 characteristics of sodium benzoate and consumer acceptance when used at rates direct agencies to assess all costs and sodium propionate. Furthermore, Kraft of up to 0.5 percent alone or 0.4 percent benefits of available regulatory conducted consumer research to with sodium benzoate. alternatives and, if regulation is demonstrate that there is consumer The Kemin petition and supporting necessary, to select regulatory acceptance, that normal spoilage material are available for viewing by the approaches that maximize net benefits indicators were not masked, that public on the FSIS Web site at http:// (including potential economic, nutrients were not adversely affected, www.fsis.usda.gov/PDF/ environmental, public health and safety and that product appearance was not Petition_Kemin.pdf. effects, distributive impacts, and equity). Executive Order 13563 changed as compared to untreated Proposed Rule product. The Kraft petition and emphasizes the importance of supporting material are available for FSIS has reviewed the data that Kraft quantifying both costs and benefits, of viewing by the public on the FSIS Web and Kemin have submitted in support of reducing costs, of harmonizing rules, site at: http://www.fsis.usda.gov/PDF/ their petitions and has determined that and of promoting flexibility. This Petition_Kraft.pdf. sodium benzoate, sodium propionate, proposed rule has been determined to In its petition, Kemin submitted data and benzoic acid, under the conditions be not significant and therefore has not collected from in-house trials and proposed in the petitions, are both safe been reviewed by the Office of university research that demonstrate and suitable for use as antimicrobial Management and Budget (OMB) under that its proposed applications of ≤ 0.5 agents in certain RTE meat and poultry EO 12866. percent liquid sodium propionate alone products. Therefore, FSIS is proposing This proposed rule would eliminate or ≤ 0.4 percent for the liquid blend of to amend 9 CFR 424.23(a)(3) to remove the need for FSIS to conduct sodium propionate with benzoate are these substances from the list of rulemakings each time that the use of effective in controlling the growth of Lm prohibited substances that may be used certain substances identified in in cured turkey and cooked chicken ‘‘* * * in or on any product, only as § 424.23(a)(3), i.e., sodium propionate, breast. Kemin noted that a comparison provided in 9 CFR Chapter III.’’ sodium benzoate, and benzoic acid, is of test results with previous studies and If this proposed rule is finalized, use found to be safe by FDA and suitable by predictive models suggests that of these substances in or on meat or FSIS for use in the production of meat moisture, pH, NaCl, added nitrite, poultry products will continue to be and poultry products at specified levels. storage temperature, and perhaps meat approved by FDA for safety and by FSIS This proposed rule would benefit type, are significant factors in for suitability. FDA will continue to companies that want to use these determining the efficacy of various establish the parameters of the approved substances in the production of meat antimicrobials. The petition explained use under its regulatory system, and and poultry products by expediting the that validation of the most effective use FSIS will list approved uses of these approval process. It would also benefit rates of any antimicrobial treatments substances in the table of approved consumers by expediting the approved will need to be performed on a case-by- substances in Directive 7120.1. The use of substances that enhance food case basis to account for many variables proposed amendment will make the safety by controlling the growth of Lm that can affect microbial growth and procedures for listing approved uses of in RTE meat and poultry products. This efficacy in specific RTE meat and sodium propionate, benzoic acid, and proposed rule would make the approval poultry products. sodium benzoate consistent with the process for new uses of sodium To show that its proposed uses of procedures for listing other safe and propionate, sodium benzoate, and liquid sodium propionate alone or in a suitable substances. This proposed rule benzoic acid in meat and poultry blend with sodium benzoate do not will also expedite the listing of products consistent with the process for conceal damage or inferiority when substances, such as sodium benzoate obtaining approval for other safe and used in meat or poultry products, and sodium propionate, which enhance suitable substances. Kemin conducted studies to food safety by controlling Lm in RTE There are no expected costs demonstrate that the use of these products. associated with this proposed rule. All substances does not affect normal FSIS is not proposing to remove substances intended for use in the spoilage indicators in RTE poultry potassium sorbate, propylparaben production of meat and poultry

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products will continue to be subject to Additional Public Notification be used in or on any meat; and niacin FDA evaluation for safety and FSIS FSIS will announce the availability of or nicotinamide shall not be used in or evaluation for suitability. Company this proposed rule on-line through the on fresh meat product; except that costs and the agencies’ costs associated FSIS Web page located at http:// potassium sorbate, propylparaben with these evaluations will not be www.fsis.usda.gov/ (propyl p-hydroxybenzoate), and affected by this proposed rule should it regulations_&_policies/ calcium propionate, may be used in or become final. The only change would be Federal_Register_Proposed_Rules/ on any product, only as provided in 9 the process for listing the substances index.asp. CFR chapter III. specified in this proposal after they FSIS also will make copies of this * * * * * have been approved. Federal Register publication available Done at Washington, DC, on May 1, 2012. Regulatory Flexibility Act through the FSIS Constituent Update, Alfred V. Almanza, which is used to provide information Administrator. Pursuant to section 605(b) of the regarding FSIS policies, procedures, [FR Doc. 2012–10871 Filed 5–4–12; 8:45 am] Regulatory Flexibility Act, 5 U.S.C. regulations, Federal Register notices, 605(b), the FSIS Administrator has FSIS public meetings, and other types of BILLING CODE 3410–DM–P made a preliminary determination that information that could affect or would this proposed rule will not have a be of interest to our constituents and significant impact on a substantial stakeholders. The Update is COMMODITY FUTURES TRADING number of small entities. This communicated via Listserv, a free email COMMISSION determination is based primarily on the subscription service for industry, trade, 17 CFR Part 49 fact that the proposed rule would not and farm groups, consumer interest affect the process for approving new groups, allied health professionals, RIN 3038–AD83 uses of sodium benzoate, sodium scientific professionals, and other propionate, and benzoic acid in meat or individuals who have requested to be Swap Data Repositories: Interpretative poultry products. This proposed rule included. The Update also is available Statement Regarding the would make the process of listing on the FSIS Web page. Through Listserv Confidentiality and Indemnification approved uses of these substances more and the Web page, FSIS is able to Provisions of Section 21(d) of the efficient by eliminating the need for provide information to a much broader, Commodity Exchange Act FSIS to conduct rulemaking each time a more diverse audience. AGENCY: Commodity Futures Trading new use is approved. In addition, FSIS offers an email Commission. Paperwork Reduction Act subscription service which provides automatic and customized access to ACTION: Proposed interpretative This rule does not contain any new selected food safety news and statement. information collection or record keeping information. This service is available at SUMMARY: The Commodity Futures requirements that are subject to the http://www.fsis.usda.gov/ Office of Management and Budget _ _ _ Trading Commission (‘‘Commission’’ or news and events/email subscription/. ‘‘CFTC’’) is proposing this interpretative (OMB) approval under the Paperwork Options range from recalls to export Reduction Act, 44 U.S.C. 3501, et seq. statement to provide guidance regarding information to regulations, directives, the applicability of the confidentiality E-Government Act and notices. Customers can add or and indemnification provisions set forth delete subscriptions themselves, and FSIS and USDA are committed to in new section 21(d) of the Commodity have the option to password-protect Exchange Act (‘‘CEA’’) added by section achieving the purposes of the E- their accounts. Government Act (44 U.S.C. 3601, et 728 of the Dodd-Frank Wall Street seq.) by, among other things, promoting List of Subjects in 9 CFR Part 424 Reform and Consumer Protection Act the use of the Internet and other Food additives, Food packaging, Meat (‘‘Dodd-Frank Act’’). The Commission information technologies and providing inspection, Poultry and poultry requests comment on all aspects of the increased opportunities for citizen products. proposed interpretative statement. The proposed interpretative statement access to Government information and For the reasons set forth in the services, and for other purposes. clarifies that the provisions of section preamble, FSIS proposes to amend 9 21(d) should not operate to inhibit or Executive Order 12988 CFR part 424 as follows: prevent foreign regulatory authorities This proposed rule has been reviewed PART 424—PREPARATION AND from accessing data in which they have under Executive Order 12988, Civil PROCESSING OPERATIONS an independent and sufficient Justice Reform. This proposed rule: (1) regulatory interest, even if that data also Has no retroactive effect; and (2) does 1. The authority citation for part 424 has been reported pursuant to the CEA not require administrative proceedings would continue to read as follows: and Commission regulations. before parties may file suit in court Authority: 7 U.S.C. 450, 1901–1906; 21 DATES: Comments must be received on challenging this rule. However, the U.S.C. 451–470, 601–695; 7 CFR 2.18, 2.53. or before June 6, 2012. administrative procedures specified in 9 2. Revise § 424.23(a)(3) as follows: ADDRESSES: Comments, identified by CFR 306.5, 381.35, and 590.300 through RIN number 3038–AD83, may be sent by 590.370, respectively, must be § 424.23 Prohibited uses. any of the following methods: exhausted before any judicial challenge * * * * * • Agency Web site, via its Comments may be made of the application of the (a) * * * Online process: http:// provisions of the proposed rule, if the (3) Sorbic acid, calcium sorbate, comments.cftc.gov. Follow the challenge involves any decision of an sodium sorbate, and other salts of sorbic instructions for submitting comments FSIS employee relating to inspection acid shall not be used in cooked through the Web site. services provided under the FMIA, sausages or any other meat; sulfurous • Mail: David A. Stawick, Secretary of PPIA, or EPIA. acid and salts of sulfurous acid shall not the Commission, Commodity Futures

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