|Food Safety and Inspection
United States Department of Agriculture
Washington, D.C. 20250-3700
Introduction. The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) is reforming current Federal regulations governing the safety, wholesomeness, and labeling of meat and poultry products to improve food safety, allow a more productive use of Federal resources, eliminate unnecessary burdens, and expand consumer choice in the marketplace. These initiatives are part of the Clinton Administration's Reinvention of Government initiative, which is designed to streamline government, make government more responsive to its customers, eliminate unnecessary regulations, and make needed regulations less burdensome and easier to use.
FSIS is undertaking a comprehensive review of its regulatory procedures and requirements to reduce regulatory burden and prepare for proposed implementation of the Pathogen Reduction and Hazard Analysis and Critical Control Points (HACCP) proposal. The proposal, which was published in the February 3, 1995, Federal Register, reflects a fundamental shift in how FSIS plans to regulate the meat and poultry industries to ensure the safety of the products they produce. In keeping with this change, the proposal will establish science-based, preventive measures to improve food safety and clarify processors responsibilities under the inspection laws. FSIS is shifting from its traditional reliance on "command-and-control"regulations to greater use of performance standards.
Performance standards provide companies an incentive to improve their processes, but it is also important that companies have the flexibility they need to innovate and efficiently meet their food safety responsibilities. This means changing or adjusting many current FSIS requirements that are no longer productive or may be counterproductive as HACCP is implemented. Any regulations that need to be changed to be consistent with HACCP will be changed before plants will be required to implement HACCP.
Second, in addition to making regulations consistent with HACCP and a greater reliance on performance standards, FSIS must eliminate any regulations that are redundant or obsolete and make its regulations less burdensome and easier to use.
Consequently, FSIS is undertaking a number of specific regulatory reforms. Implicit in these initiatives is a commitment to reassess how FSIS conducts inspection. The Agency's current requirements for "prior approvals" and "food standards of identity" are two examples of areas where changes are being proposed.
FSIS is reviewing and adjusting, as necessary, its prior-approval programs. The current meat and poultry inspection program is based on intensive command and control oversight of plant operations, including prior-approval systems for facility, blueprints, equipment, in-plant chemicals, ingredients, process changes and labels. FSIS approves virtually everything used during the slaughter and processing of meat and poultry that might affect the safety, quality, or wholesomeness of the food. FSIS also conducts a prior-approval program for the labels of federally inspected meat and poultry products and imported products to ensure they comply with the requirements of the inspection laws. FSIS believes that prior-approval systems consume significant public and private resources that could be better used in reducing the public's risk of foodborne illness. In addition, reforming these systems would clarify the proper roles of government and industry in ensuring safe food.
FSIS is also undertaking a comprehensive review of all of its product standards. Food standards of identity or composition were originally established to protect consumers from economic deception. They define a food s composition and prescribe minimum levels of certain ingredients, such as meat in meat food products, or maximum levels for cheaper ingredients, such as fillers or water. The meat and poultry inspection regulations include 60 definitions and standards of identity and composition covering such products as hamburger, cooked sausages, poultry rolls, corned beef, and frankfurters.
FSIS is reassessing the need for product standard regulations. The "standards of identity" may discourage product innovation, including the marketing of reduced fat and other nutritionally improved meat and poultry products. The trend in the production of products that resemble traditional products but contain less fat and cholesterol indicates a need to question the justification for new standards and consider the elimination of old ones. The Agency will consider whether alternative approaches would work better to ensure consumers are adequately informed and get what they believe they are paying for, while providing industry greater flexibility to innovate and expand consumer choices in the marketplace.
On December 29, 1995, FSIS published the following four documents as part of its regulatory reform initiatives:
Summary: The proposal would harmonize and streamline the procedures used by FSIS and the Food and Drug Administration (FDA) for reviewing and approving the use of substances in meat and poultry products. Under current procedures, due to differing statutory mandates, both agencies conduct separate reviews and carry out separate rulemakings before a new substance can be permitted in a meat or poultry product. Under the proposal, FSIS would no longer issue its own regulations listing substances it finds suitable for use in meat and poultry products. Instead, future FDA regulations would specify whether a substance approved for use in foods under the Federal Food, Drug, and Cosmetic Act may be used in or on meat or poultry products. Thus, only one rulemaking would be required.
Summary: The current regulations covering standards of identity and composition state that particular product names may be used only if the product has been prepared with specific ingredients or in a specified manner. These standards often discourage the production of processed meat and poultry products with reduced levels of fat, cholesterol, and sodium. To encourage the marketing of these nutritionally modified meat and poultry products, FSIS is proposing to permit manufacturers, under certain conditions, to deviate from the standard of identity while still using the traditional standardized name. The standardized name would have to be used in conjunction with an approved nutrient content claim. An example is a "low-fat frankfurter" that exceeds current requirements for added substances such as water and binders in order to reduce the fat content.
Summary: Under the Agency s prior approval system for product labels, certain categories of labels are exempt from the prior approval requirement. FSIS is finalizing its November 23, 1993, proposal to expand the types of labeling authorized for use on meat and poultry products that are exempt from prior Agency review. In addition, in those instances where labeling is required to be submitted for Agency approval, FSIS is permitting companies to submit only sketch labeling to eliminate duplication. Under the current system, FSIS reviews most meat and poultry product labels twice-first in a rough draft, or sketch, and then in final form. The rule becomes effective July 1, 1996.
FSIS plans to publish the following three documents early in 1996:
Summary: The notice will invite comments on the current regulations covering standards of identity and composition, which state that particular product names may be used only if the product has been prepared with specific ingredients or in a specified manner. FSIS will be considering whether to modify or eliminate specific standards or to modify its regulatory approach to standardized foods.
Summary: The current regulations for the production of cooked beef products, uncured meat patties, and certain poultry products prescribe a precise sequence of steps to be followed to produce safe food. FSIS will propose performance standards to supplement the current regulations governing the production of these products to provide industry with more flexibility in determining processing procedures while maintaining the same high standards for food safety. The proposed performance standards will spell out the objective level of performance that plants must meet during their operations to produce safe products so as to allow the use of processing procedures other than those prescribed in the current regulations.
Summary: The Agency's prior-approval systems consume significant public and private sector resources that could be better used in reducing the risk of foodborne illness. In addition, they conflict with the Agency s goal of setting appropriate standards for food safety and then holding companies responsible for meeting those standards. Therefore, FSIS will be proposing to eliminate current requirements for the approval of plant drawings and specifications and equipment before they can be used in federally inspected meat and poultry plants. FSIS will be proposing to eliminate current requirements for prior approval of most plant-operated quality control programs in order to encourage the industry to take more control of their safety assurance processes.
The regulatory reform initiatives are an important component of the FSIS strategy for the future. The strategy begins with the Agency s proposal on Pathogen Reduction and HACCP, in which the Agency proposed to mandate the preventive system of process control known as HACCP, establish science-based regulatory performance standards in meat and poultry slaughter and processing plants, and mandate certain near-term interventions that address, among other things, plant sanitation. The current meat and poultry inspection system makes important contributions to the safety and quality of the food supply, but the system is not based sufficiently on the principle of prevention; it is not designed to target and reduce harmful bacteria on raw products; and it does not make the best possible use of resources. These proposals would provide a means of better targeting harmful bacteria on meat and poultry products, more clearly delineating Government and industry responsibility for producing safe meat and poultry, and enable the government to focus more productively on food safety priorities.
In addition to the proposed changes for meat and poultry plants, FSIS is also taking steps to prevent hazards and reduce the risk of foodborne illness from farm to table.
As a complement to the regulatory reform initiatives described in this document, FSIS has conducted a top-to-bottom review of the Agency to examine its regulatory roles, how it allocates resources, and how it is organized to achieve its food safety goals. The Agency must ensure that it is making the best use of its resources to improve food safety. The recommendations of the review have been released for public comment.
Comments on the proposals and advance notices of proposed rulemaking will be due February 27, 1996, and should be submitted to Diane Moore, Docket Clerk, Room 3171 South Building, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
For Further Information Contact:
FSIS Congressional and Public Affairs Staff
Phone: (202) 720-3897
Fax: (202) 720-5704
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