[Federal Register: June 7, 2001 (Volume 66, Number 110)]
[Page 30683-30686]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food Safety and Inspection Service

[Docket No. 00-035N]

FSIS--A Public Health Approach to Processing Inspection

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of public meeting; request for comments.


SUMMARY: 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.

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

ADDRESSES: 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 ``http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov/OM/planning/sp2005.htm''. Copies will also be 
available at the meeting.

FOR FURTHER INFORMATION CONTACT: 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.



    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

[[Page 30684]]

presented 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 
    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 

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 
    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.

[[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 
    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

[[Page 30686]]

public 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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov. 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.

    Done at Washington, DC on: May 31, 2001.
Thomas J. Billy,
[FR Doc. 01-14474 Filed 6-5-01; 1:59 pm]