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FSIS-A Public Health Approach to Processing Inspection

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Food Safety and Inspection Service, USDA.


Notice of public meeting; request for comments.


The Food Safety and Inspection Service (FSIS) will hold a public meeting, which is intended to be the first in a series, on an FSIS initiative to improve its inspection of processed meat and poultry products. At the first meeting, the Agency will provide an overview of the Agency's use of risk analysis in protecting public health. The Agency will also review its Strategic Plan for 2000-2005, and discuss its view of the key attributes of a public health regulatory agency. The Agency will then discuss the next steps that it proposes to take to develop an inspection system that minimizes the risks from processed products while making optimal use of processing inspection resources, and will invite comments on these next steps and on how best to achieve the Agency's objectives.


The public meeting is scheduled for June 7, 2001, from 9:00 am to 4:00 pm.


The meeting will be held at the Holiday Inn—Capitol, 550 “C” Street, SW., Washington, DC 20024.

Comments: FSIS welcomes comments at any time on the topics to be discussed at the public meeting, and particularly on the Agency's strategic plan. Please send an original and two copies of comments to the Food Safety and Inspection Service Docket Clerk: Docket #00-035N, Room 102 Cotton Annex Building, 300 12th Street, SW., Washington, DC 20250. Comments may also be sent by facsimile to (202) 205-0381. The comments and the official transcript of the meeting, when it becomes available, will be kept in the Docket Clerk's office at the above address. FSIS has made copies of the FSIS Strategic Plan for 2000-2005 available in the docket room and on the FSIS website at “​OM/​planning/​sp2005.htm. Copies will also be available at the meeting.

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Dr. Jane Roth, Director, Program Evaluation and Improvement Staff, Office of Policy, Program Development and Evaluation, at (202) 720-6735. Registration for the meeting will be on-site. Persons requiring a sign language interpreter or other special accommodation should notify Ms. Sheila Johnson at (202) 690-6498 by June 1, 2001.

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FSIS administers the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. The Agency's activities are intended to prevent the distribution in interstate or foreign commerce, for human food purposes, of adulterated or misbranded meat, poultry, and egg products, including products that may transmit diseases or that may be otherwise injurious to health.

In recent years, the Agency has placed increased emphasis on its public health protection role. Throughout the 1990's, the Agency's most important goal was an improved food safety inspection system, exemplified by the Pathogen Reduction/Hazard Analysis and Critical Control Point (PR/HACCP) regulations which were fully implemented last year. FSIS has consistently sought the enhancement of public health by minimizing foodborne illness from meat, poultry, and egg products. The Agency has worked toward achieving this by measures intended to reduce pathogens on raw products, by strengthening relationships with public health agencies at the Federal and State levels, food safety information and training at every point in the food production and marketing chain, and by promoting international cooperation in the field of food safety.

The Agency's Strategic Plan for 2000-2005 proposes that FSIS continue to focus its operations and resources on food safety and continue to strengthen the scientific basis for its regulatory activities and initiatives.

FSIS wants the views, suggestions and comments of all of its food safety constituencies, and the general public on the approaches it is considering or should consider to achieve its mission.

Public Meeting

At the first public meeting, on June 7, 2001, FSIS officials will review the Agency's Strategic Plan for 2000-2005, and will discuss the basic public health objectives and the strategy for achieving these objectives. They will also discuss the role of risk analysis especially with respect to the optimal use of processing inspection resources; the next steps that FSIS proposes to take toward minimizing the risk to consumers of foodborne illness; and the coordination of the Agency's efforts with international authorities, other Federal agencies, and State and local authorities. Finally, the Agency will open the discussion and solicit comment from the attendees.

The following summarizes the major themes that will be discussed at the first meeting.

FSIS Strategic Plan 2000-2005

In its Strategic Plan for 2000-2005, FSIS has proposed a long-range program for protecting the public health by improving the Agency's effectiveness as a public health regulatory agency. In order to do this, the Agency has established as its strategic goal the protection of the public health by significantly reducing the prevalence of foodborne hazards from meat, poultry, and egg products. To achieve this goal, the Agency will use the risk analysis model—consisting of risk-assessment, risk-management, and risk-communication segments—recommended by the National Academy of Sciences to regulatory agencies. This model is reflected in the objectives the Agency seeks to meet in achieving its strategic goal.

The first objective is to provide national and international leadership by building within the Agency a risk assessment capability, supported by the latest research and technology, that can be applied to meat, poultry, and egg products. Risk assessment will help the Agency improve its operations to better ensure the safety of meat, poultry, and egg products. Better risk assessment is needed to strengthen the scientific basis for food safety polices and regulatory decisions.

The second objective is to create a coordinated national and international system to manage, from farm-to-table, the food safety risks that may be Start Printed Page 30684presented by meat, poultry, and egg products. Risk managers weigh, in the context of the social and economic environment, the scientific and technical evidence gathered through risk assessments. The conclusions they draw enable them to better direct efforts to reduce, eliminate, or control risks to public health.

FSIS, working with all stakeholders in the farm-to-table continuum, must ensure that public health risks are identified, and that steps are taken to prevent, eliminate, or minimize those risks. The Agency needs to play a more focused and creative role in managing the risks associated with producing, processing, transporting, storing, retailing, and delivering meat, poultry, and egg products to consumers. It also needs to support more rigorous application of risk management strategies at the international level so that products imported into the United States will meet standards equivalent to those that apply to domestic products.

The third objective is to conduct a comprehensive national and international risk communication program that is an open exchange of information and opinion on risk among risk assessors, risk managers, and the public. The risk communication program should promote public confidence in food safety through effective, open, and timely information exchange and science-based education on decisionmaking with respect to food-safety risks, limits to total risk elimination, and prevention and protection strategies. The program would emphasize both education and explanation of issues involved in considering stakeholder views, knowledge, and receptiveness to Agency risk assessments and risk-management decisions.

The fourth objective is to create and maintain an FSIS infrastructure to support the risk assessment, risk management, and risk communication objectives. To enhance public health, FSIS will have to conduct science-based food inspection and invest in the elements of risk analysis, food safety technology, scientific methods, and business process re-engineering, along with workforce training, development, hiring, and retention. New methods of inspection will be based increasingly on science and will require a more scientifically trained workforce.

In striving to improve food safety and to achieve the goals and objectives of the strategic plan, FSIS believes that it can substantially improve its effectiveness as a public health regulatory agency.

Key Attributes for a Public Health Regulatory Agency

FSIS believes that a public health regulatory agency should embody at least eight key attributes. The first attribute is a public health orientation. FSIS acquires its public health orientation from its legislative mandate to ensure that meat, poultry, and egg products distributed in commerce are wholesome, not adulterated, and properly marked, labeled, and packaged. FSIS exercises its responsibilities by maintaining inspection in approximately 6,000 plants that slaughter cattle, swine, sheep, goats, horses, mules, other equines, and poultry, or that prepare a wide range of further processed products, such as hams, sausages, stews, egg-based mixes, and frozen dinners. The Agency carries out a wide range of scientific support, inspection and compliance, and international activities in fulfilling its public health mission.

The second attribute is a regulatory strategy built on science-based systems to achieve public health goals. These systems include the Pathogen Reduction/Hazard Analysis and Critical Control Point (PR/HACCP) regulations, which require establishments to develop and carry out sanitation standard operating procedures and HACCP plans and meet process control criteria for generic Escherichia coli and pathogen reduction performance standards for Salmonella. FSIS is also developing a capability to conduct food safety risk assessments on which to base its regulatory programs. Another example is the Agency's participation, with the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), in FoodNet, an active surveillance network for foodborne disease that provides national estimates of the burden and sources of specific foodborne diseases in the United States.

The third attribute is adopting measures of success to gauge progress in achieving its public health goals. Such measures are contained in the Agency's strategic plan. The Agency's measures for risk management include percentage reductions in the prevalence of Salmonella on raw meat and poultry products, percentage reductions in the prevalence of Listeria monocytogenes in ready-to-eat meat and poultry products, and the number of risk management policies and decisions made that are based on risk assessments.

The fourth attribute is an open and inclusive manner for the conduct of business, as evidenced by public meetings with constituency groups on issues that bear on the Agency's goals. From the beginning of its development of the PR/HACCP regulations to the present, FSIS has carried out its public health regulatory initiatives in an open and transparent manner. The Agency plans to continue this public process for future public health initiatives, including its risk assessments.

The fifth attribute is that the assurance that each of its organizational elements contribute to the achievement of the Agency's public health goals. For FSIS, this means that public health-related activities have a priority claim on its inspection, laboratory, administrative, and other resources.

The sixth attribute is the employment of public health professionals. FSIS employs a growing number of individuals with specialized qualifications, including consumer safety officers, epidemiologists, microbiologists, biostatisticians, risk analysts, chemists, toxicologists, veterinary medical officers, and medical officers.

The seventh attribute is the development of external relationships to mobilize other public health resources. Already mentioned is the FoodNet collaboration with CDC and FDA. In epidemiological investigations, FSIS collaborates with these and other Federal agencies and with State and local governments. In drug residue investigations, FSIS may work with FDA. In investigations of zoonotic disease outbreaks, FSIS may work with USDA's Animal and Plant Health Inspection Service or State veterinarians.

The eighth attribute is the use of scientific data to make decisions and allocate resources. In support of its inspection program, FSIS conducts directed sampling for drug and other chemical residues and microbial pathogens, gathers or makes use of existing data on prevalence and enumeration of microbes, investigates conditions of consumer and retail storage, gathers handling and preparation data, follows reports of scientific studies by ARS and other researchers, and uses data from its own or others' risk assessments in making regulatory and resource allocation decisions.

FSIS' strategic plan specifies a program for strengthening each of the foregoing attributes. However, the Agency is and will continue to be open to any ideas or suggestions that will help meet future challenges wherever they arise. Start Printed Page 30685

Next Steps Toward Farm-to-Table Food Safety Assurance

Last year, FSIS completed its phased implementation of the PR/HACCP regulations in all official establishments. Since then, the Agency has turned its attention to determining how to improve the quality and effectiveness of industry food safety programs, including HACCP, and how to improve the Agency's effectiveness as a public health regulatory agency. The Agency has been paying increased attention to regulatory reform, in-plant staffing patterns, residue control in a HACCP environment, and overall improvements in the Agency's ability to respond to future food safety problems.

FSIS has addressed a number of food safety and regulatory reform issues that were deferred while the PR/HACCP regulations were being put in place. For example, the Agency has advanced the process of converting command-and-control requirements to performance standards by issuing a final rule on sanitation and a proposed rule on processed, ready-to-eat meat and poultry products.

The Agency is following the principle of risk-based program design in the reform of its program management infrastructure in both slaughtering and further processing environments. Program infrastructure is a broad area that encompasses assignment of work, expertise and training, data analysis and decisionmaking, communication, and workplace environment.

The Agency has completed significant work on its HACCP-based inspection models project (HIMP) for slaughter plants. This project involves testing a new inspection system under which FSIS targets its resources on carcass conditions that have human health implications. The Agency has also begun to study how it can more effectively use its processing inspection resources by targeting areas where the inherent hazards of products and processes to public health are greatest.

The Agency is initiating new activities and data reports for addressing the hazard to public health posed by products and operations. The Agency intends to rely increasingly on microbiological sampling programs and on the use of epidemiological data on foodborne outbreaks in which meat, poultry, or egg products have been implicated. The Agency also plans to move to a system of team inspection, involving the use of personnel with different types of expertise, to assess the performance of HACCP systems and to deal with food safety problems. FSIS is designing a dynamic process for responding to and addressing public health problems. As envisioned, this process will rely on a variety of data sources, interdisciplinary teams, and coordination with State and other Federal agencies.

The Agency is also developing plans to intensify its efforts at both ends of the farm-to-table chain. For example, FSIS is exploring the possibility of using veterinary medical officers in ways that would enhance the reliability and effectiveness of farm-to-table food-safety controls.

One idea the Agency is exploring is that of ensuring the availability to District Managers (DMs) of public health data resources and personnel that would improve the ability of the DMs to carry out the Agency's public health strategy. The DMs will play a central, coordinating role under the Agency's reform plans. Possible resources that can be made available to the DMs include special surveys and reviews by teams of specialists; inspection management and enforcement reports; and the results of sampling for Salmonella and other pathogens. Also available to them will be district-specific resources, such as personnel with special expertise, risk evaluation data for products and processes, and current information on plant construction, management issues, and pending enforcement actions.

The Agency is developing a plan for delivering HACCP-related training to its personnel through work-unit meetings. The Agency recognizes that it must improve the ability of its personnel to understand their regulatory authorities, to assess the effectiveness of establishment sanitation standard operating procedures and HACCP plans, and to identify hazards to public health on which action must be taken.

Risk Analysis-Based Approach to Improving Processing Inspection in a Public Health Regulatory Agency

As mentioned above in the context of the Agency's strategic plan, FSIS has chosen a risk analysis-based approach to achieve its strategic goal of reducing the likelihood and prevalence of foodborne hazards in meat, poultry, and egg products. Risk analysis, which consists of risk assessment, risk management, and risk communication, is recognized as a logical and systematic approach to food safety both nationally, for example, by the National Academy of Sciences, and internationally, for example, by the Codex Alimentarius Commission. A risk analysis-based approach to inspection will ensure that hazards to consumers from meat, poultry, and egg products will be minimized.

FSIS is considering the types of information and data needed for a risk-analysis based improvement of processing inspection systems. The Agency believes that the information would include the likely hazards associated with meat, poultry and egg products for each establishment; the processes each establishment uses to produce the product; and the volume of product produced by each establishment. The Agency is also evaluating CDC reports on foodborne illness by location, population segment, organism, and type of food product implicated in the spread of illness. The Agency is studying how it can use such data to determine the magnitude of hazards and the possibility of consumer exposure to those hazards.

The Agency is also trying to determine its future data needs as it moves toward a more risk analysis-based processing inspection system. The Agency believes it will need more information on such things as retail and consumer behavior patterns (e.g., storage, handling and cooking of food), dose-response relationships (e.g., among susceptible populations), and consumption patterns (i.e., frequency and serving size consumed), as well as a better understanding of the growth and decline of microbial populations.

Implications for Processing Inspection

As the Agency's risk analyses produce more and better quality data and information on the public health risks of food products that are subject to the Agency's regulations, the Agency will use the data and information to reassess its inspection of the processing of meat and poultry products. FSIS has been documenting and analyzing the accomplishments of the current processing inspection system, particularly as that system has been operated in the PR/HACCP environment. In evaluating the current system, the Agency has already found that there are areas where the allocation of processing inspection resources potentially limits the public health effectiveness of the Agency.

FSIS is beginning to explore changes in processing inspection that may be needed to enable the Agency to meet the goals and objectives of its Strategic Plan and to fully function as a public health regulatory agency. FSIS is considering ways of optimizing processing inspection in the light of risk analysis. The Agency is also considering how to use the information from risk analyses to provide its managers with the appropriate decision-making tools, data, and personnel resources that they would need to carry out the Agency's Start Printed Page 30686public health strategy at the field management level.

Additional Public Notification

Public awareness of all segments of policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this public meeting, FSIS will announce it and provide copies of this Federal Register publication in the FSIS Constituent Update. FSIS provides a weekly FSIS Constituent Update, which is communicated via fax to over 300 organizations and individuals. In addition, the update is available on line through the FSIS web page located at The update is used to provide information on FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and any other types of information that could affect or would be of interest to our constituents/stakeholders. The constituent fax list consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals that have requested to be included. Through these various channels, FSIS is able to provide information to a much broader, more diverse audience. For more information and to be added to the constituent fax list, fax your request to the Congressional and Public Affairs Office, at (202) 720-5704.

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Done at Washington, DC on: May 31, 2001.

Thomas J. Billy,


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[FR Doc. 01-14474 Filed 6-5-01; 1:59 pm]