[Federal Register Volume 59, Number 3 (Wednesday, January 5, 1994)] [Proposed Rules] [Pages 550-551] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-105] [[Page Unknown]] [Federal Register: January 5, 1994] VOL. 59, NO. 3 Wednesday, January 5, 1994 ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Part 318 [Docket No. 92-029P] RIN 0583-AB66 Sodium Citrate as a Tripe Denuding Agent AGENCY: Food Safety and Inspection Service, USDA. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to amend the Federal meat inspection regulations to permit the use of sodium citrate in solution to denude beef stomachs of mucous membranes. In 1990, a manufacturer of processing aids and other direct food ingredients petitioned the Food and Drug Administration and FSIS to approve the use of several compounds, including sodium citrate, for use in denuding tripe. FSIS has reviewed the data and other information submitted by the petitioner and has determined that the proposed use of sodium citrate would not result in product adulteration or misbranding. The proposed regulation would make available to meat processors an additional, alternative tripe-denuding formulation that would contain sodium citrate as an ingredient. The sodium citrate solution would be as effective as existing tripe-denuding agents, but would be less objectionable to workers than the agents now in use. The sodium citrate-containing formulation would contribute to improved tripe production. DATES: Comments must be submitted on or before March 7, 1994. ADDRESSES: Written comments to: Policy Office, Attn. Diane Moore, FSIS Hearing Clerk, room 3171 South Agriculture Building, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. FOR FURTHER INFORMATION CONTACT: Dr. Bill James, Director, Slaughter Inspection Standards and Procedures Division, Science and Technology, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, (202) 720-3219. SUPPLEMENTARY INFORMATION: Executive Order 12866 This proposed rule is in conformance with Executive Order 12866, and the Assistant Secretary has determined that it is not a ``significant regulatory action.'' This proposed rule: (1) Would have an effect on the economy of less than $100 million; (2) would not adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health and safety, or State, local or tribal governments or communities; (3) would not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (4) would not alter the budgetary impact of entitlements, grants, user fees, or loan programs or rights or obligations or recipients thereof; and (5) would not raise novel legal or policy issues arising out of legal mandates, the President's priorities, or principles set forth in Executive Order 12866. Executive Order 12778 This proposed rule has been reviewed under Executive Order 12778, Civil Justice Reform. States and local jurisdictions are preempted under the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) from imposing requirements with respect to premises, facilities, and operations of federally inspected meat or poultry products, and any marking, labeling, packaging, or ingredient requirements on federally inspected meat and poultry products that are in addition to, or different than, those imposed under the FMIA and PPIA. States and local jurisdictions may, however, exercise concurrent jurisdiction over meat and poultry products that are outside official establishments for the purpose of preventing the distribution of meat and poultry products that are misbranded or adulterated under the FMIA or PPIA, or in the case of imported articles, which are not at such an establishment, after their entry into the United States. The States may, however, impose more stringent requirements on such State inspected products and establishments. This proposed rule is not intended to have retroactive effect, and no applicable administrative procedures must be exhausted before any judicial challenge to the provisions of this rule. However, the applicable administrative procedures specified in 9 CFR 306.5 must be exhausted prior to any judicial challenge to the application of the provisions of this rule, if the challenge involves any decision of an inspector relating to inspection services provided under the FMIA. The applicable administrative procedures specified in 9 CFR part 335 must be exhausted prior to any judicial challenge to the application of the provisions of this rule with respect to labeling decisions. Effect on Small Entities The Administrator has determined that this proposed rule will not have a significant impact on a substantial number of small entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601). The proposed regulation would make available to meat processors an additional, alternative tripe-denuding formulation that would contain sodium citrate as an ingredient. The sodium citrate formulation could be manufactured and sold in liquid form and used in existing or newly developed tripe denuding equipment. The sodium citrate-containing formulation could be used most efficiently in the new equipment and contribute to improved tripe production. Small establishments could benefit from the use of the sodium citrate product. Background Under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), FSIS provides for mandatory inspection of meat and meat food products shipped in interstate and foreign commerce. The Act prohibits the addition of any substance to any meat or meat food product that may render the product adulterated (21 U.S.C. 601). Section 318.7(a)(1) of the Federal meat inspection regulations (9 CFR 318.7) prohibits the use of any substance in the preparation of any product unless its use is approved in Sec. 318.7(c)(4) of the Federal meat inspection regulations (9 CFR 318.7), which is the chart of substances acceptable for use in the preparation of products, or unless it is approved elsewhere in the regulations or it is approved by the Administrator. In 1990, a manufacturer of processing aids and other direct food ingredients petitioned the Food and Drug Administration (FDA) and FSIS to approve the use of several compounds, including sodium citrate, for use in denuding tripe. Tripe denudation--the removal of mucous membranes from beef stomachs--is a necessary step in the cleaning and preparation of tripe for use as human food. FSIS has reviewed the data and other information submitted by the petitioner and has determined that the proposed use of sodium citrate would not result in product adulteration or misbranding. FDA lists sodium citrate as generally recognized as safe when used in accordance with good manufacturing practice in an amount not in excess of that required to achieve its intended effect (21 CFR 182.1751). In an August 24, 1992, letter to the petitioner, FDA reported this fact and stated that it would have ``no objection to [sodium citrate's] addition to the tripe-denuding mixture [contemplated by the petitioner] providing that it is used in accordance with good manufacturing practice.''1 FDA further stipulated that the sodium citrate used be of food-grade quality and that the quantity used not be in excess of the amount reasonably required to accomplish its intended effect. --------------------------------------------------------------------------- \ \A copy of this letter is available from the FSIS Hearing Clerk, USDA, 14th & Independence Avenue, SW., room 3175, South Agriculture Building, Washington, DC 20250. --------------------------------------------------------------------------- FSIS is proposing to amend Sec. 318.7(c)(4) of the Federal meat inspection regulations to permit the use of sodium citrate as a tripe denuding agent in combination with other approved agents, in an amount sufficient to accomplish the intended effect. Use of sodium citrate for this purpose would be subject to the condition that the substance be removed from the denuded tripe by rinsing with potable water. List of Subjects in 9 CFR Part 318 Food additives, Meat inspection. For the reasons set out in the preamble, 9 CFR part 318 is proposed to be amended as follows: PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS 1. The authority citation for part 318 would continue to read as follows: Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 2.17, 2.55. 2. Section 318.7(c)(4) would be amended by adding to the chart of substances, under the Class of substance ``Denuding agents; may be used in combination. Must be removed from tripe by rinsing with potable water.'' the substance sodium citrate in alphabetical order as follows: Sec. 318.7 Approval of substances for use in the preparation of products. * * * * * (c) * * * (4) * * * ---------------------------------------------------------------------------------------------------------------- Class of substances Substances Purpose Products Amount ---------------------------------------------------------------------------------------------------------------- ****** * Denuding Agents; may be used in Sodium Citrate.... ......do.......... ......do.......... Do. combination. Must be removed from tripe by rinsing with potable water. ****** * ---------------------------------------------------------------------------------------------------------------- Done at Washington, DC, on December 27, 1993. Eugene Branstool, Assistant Secretary, Marketing and Inspection Services. [FR Doc. 94-105 Filed 1-4-94; 8:45 am] BILLING CODE 3410-DM-M