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Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
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Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
Backgrounders
January 1998; Slightly Revised May 1998
Contact information updated December 1998
The Food Safety and Inspection Service (FSIS) is creating a new regulatory system for meat and poultry safety within the meat and poultry plants it regulates. The new, science-based system will improve food safety and make better use of Agency resources. The system has four major components. First, FSIS is requiring the plants it regulates to implement Hazard Analysis and Critical Control Points (HACCP) systems as a tool for preventing and controlling contamination so products meet regulatory standards. Second, FSIS established food safety performance standards that plants must meet and is conducting testing and other activities to ensure those standards are met. Third, FSIS is training its inspectors to provide the oversight that is necessary to ensure that industry is meeting regulatory standards. Fourth, FSIS has reorganized to strengthen its enforcement to deal with plants that do not meet regulatory standards.
The Pathogen Reduction and HACCP rule is the centerpiece of the new regulatory approach because it mandates HACCP, sets certain food safety performance standards, establishes testing programs to ensure those standards are met, and assigns new tasks to inspectors to enable them to ensure regulatory performance standards are met.
FSIS is carrying out other activities to complete the new regulatory approach. For instance, to improve the inspection component even further, FSIS is exploring what changes should be made to the current system of carcass-by-carcass inspection that inspectors carry out to prevent diseased animals from being used for food. FSIS believes this function remains critically important but that in light of improvements in process control that are occurring under HACCP, changes to the tasks currently performed by FSIS inspectors can be made to improve inspection effectiveness and make the use of inspection resources more productive. Such change will provide resources to carry out the new tasks created for inspectors under the Pathogen Reduction and HACCP rule and to redeploy inspection resources to ensure that food safety is maintained once products leave the inspected plant.
In addition to this new regulatory approach within FSIS-regulated plants, the Agency is working with other government agencies, industry, and academia to develop and take steps to improve food safety from farm to table. FSIS has historically focused on the manufacturing of meat and poultry products through its inspection program within plants, but the Agency is also considering hazards before animals reach the plant, and after products leave the plant, as part of its comprehensive public health strategy to prevent foodborne illness.
FSIS has also been conducting risk assessments to assess the public health risks associated with the consumption of meat, poultry, and egg products. The farm-to-table approach to risk assessment as implemented by FSIS provides a means by which various intervention and control strategies can be identified and evaluated throughout the food chain. The information obtained from these risk assessments will be used for better informed decision making and policy development by focusing resources toward the most effective and efficient risk reduction actions.
These changes from farm to table will reduce the incidence of foodborne illness attributed to meat and poultry products. FSIS is developing similar changes for egg products.
The Food Safety and Inspection Service is the Agency within the U.S. Department of Agriculture responsible for ensuring the safety, wholesomeness, and accurate labeling of meat, poultry, and egg products. On July 25, 1996, FSIS issued its landmark rule, Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems. The rule addresses the serious problem of foodborne illness in the United States associated with meat and poultry products by focusing more attention on the prevention and reduction of microbial pathogens on raw products that can cause illness. It also clarifies the respective roles of government and industry in food safety. Industry is accountable for producing safe food. Government is responsible for setting appropriate food safety standards, maintaining vigorous inspection oversight to ensure those standards are met, and maintaining a strong enforcement program to deal with plants that do not meet regulatory standards.
The Pathogen Reduction and HACCP rule: (1) requires all meat and poultry plants to develop and implement a system of preventive controls, known as HACCP, to improve the safety of their products, (2) sets pathogen reduction performance standards for Salmonella that slaughter plants and plants producing raw ground products must meet, (3) requires all meat and poultry plants to develop and implement written standard operating procedures for sanitation, and (4) requires meat and poultry slaughter plants to conduct microbial testing for generic E. coli to verify the adequacy of their process controls for the prevention of fecal contamination. Implementation of the rule began on January 27, 1997, and will be completed by January 25, 2000.
FSIS has prepared extensively for the implementation of the final rule by providing technical assistance to small plants, training its workforce, undergoing a reorganization, and reforming its regulations to be consistent with HACCP.
Foodborne illness is a serious problem in the United States. Foodborne microbial pathogens account for an estimated 6 to 33 million cases of foodborne illness each year, and up to 9,000 deaths. Of this, 5 million illnesses and 4,000 deaths are attributed to meat and poultry products. The four most common pathogens associated with meat and poultry products are Campylobacter jejuni/coli, E. coli O157:H7, Salmonella, and Listeria monocytogenes.
FSIS is the agency within the U.S. Department of Agriculture responsible for ensuring the safety, wholesomeness, and accurate labeling of meat, poultry, and egg products. Billions of pounds of roasts, chops, frankfurters, hamburgers, chicken nuggets, pasteurized egg products, and TV dinners are produced each year. FSIS operates under the authority of the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. FSIS sets standards for food safety and inspects meat, poultry, and egg products produced domestically and imported.
The traditional inspection program, with its emphasis on organoleptic (sight, touch, and smell) methods, has been successful in removing diseased animals from the food supply and enforcing other consumer protection standards. At the time the first major meat inspection law was passed in 1907, animal diseases were the major concern, and invisible hazards such as pathogenic microorganisms had not yet attracted the attention of public health authorities and regulators. Since that time, however, animals have become healthier. Changes in the meat and poultry industries have resulted in products having a wider distribution, potentially affecting large numbers of people. In addition, the growing concern with microbial pathogens, and, in particular, emerging pathogens, and the development of new technologies to control pathogens on raw products have contributed to the need for new approaches to ensuring food safety.
Scientific support for new approaches to ensuring food safety has existed for some time. In 1983, the National Academy of Sciences, at FSIS' request, issued its report Meat and Poultry Inspection--The Scientific Basis of the Nation's Program, followed in 1987 by a second report entitled Poultry Inspection--The Basis for a Risk-Assessment Approach. In addition to these reports, numerous studies by the Congress' General Accounting Office, and by FSIS itself, established the need and approach. In general, these reports have supported the need for FSIS to better address pathogenic microorganisms and to have industry implement systems that prevent food safety problems in plants.
Despite overwhelming scientific support for change, progress occurred very slowly. In late 1992 and early 1993, however, an outbreak of E. coli O157:H7 attributed to undercooked hamburgers served at a fast-food restaurant, highlighted the weaknesses in the traditional system and provided a national impetus for ground breaking change.
Acting quickly to address the problem, USDA began by issuing a rule requiring safe handling labels that address storage, cooking, and holding practices for raw meat and poultry products. In 1994, USDA declared E.coli O157:H7 an adulterant in ground beef and established a monitoring program for the pathogen in ground beef.
USDA also began work on its Pathogen Reduction and Hazard Analysis and Critical Control Points (HACCP) rule, and after an extensive public rulemaking process, published its rule on July 25, 1996.
The final rule applies to the approximately 6,500 federally-inspected and 2,550 state-inspected slaughter and processing plants in the United States. In addition, the rule applies to countries that export meat and poultry products to the United States. Egg products are not covered by the final rule, but the Agency has developed a strategy, including HACCP, to improve the safety of eggs and egg products.
The rule has four major components:
1. HACCP
HACCP is a way for industry to control and prevent problems and ensure safe food by controlling the production process from beginning to end, rather than detecting problems at the end of the line. HACCP is widely recognized by scientific authorities and international organizations and is used extensively in the food industry to produce products in compliance with health and safety requirements.
Under HACCP, a plant analyzes its processes to determine at what points hazards might exist that could affect the safety of its products. These points are called critical control points (CCPs). Examples of critical control points are chilling; the cooking process; processing procedures, such as filling and sealing cans; and certain slaughter procedures, such as removal of internal organs. The location and number of hazards will differ greatly depending on type of facility, foods prepared, processing procedures used, and many other factors. Once the CCPs are identified, the plant must establish critical limits. Critical limits are usually expressed as numbers representing such parameters as time/temperature, humidity, water activity, pH, salt concentration, and chlorine level. Critical limits may be in the regulations, such as the requirement that poultry be chilled to 40 degrees F., or they may be established by the plant based solely on the scientific and technical literature or recommendations of experts. Next, the plant establishes monitoring requirements for each CCP and corrective actions to be taken when monitoring indicates there is a deviation from an established critical limit. Examples of corrective actions are adjusting the process, holding and destroying all product if it cannot be brought into compliance, and developing an alternative process. The plant must also establish record keeping procedures that document the operation of the HACCP system and verify that controls are working as intended.
Under the new rule, all plants must develop and implement a HACCP plan for each of their processes. HACCP plans must conform to the seven HACCP principles established by the National Advisory Committee for Microbiological Criteria for Foods. (See the HACCP Key Facts.) HACCP plans are required to cover those CCPs that affect product safety, as opposed to those related to economic adulteration, labeling, or quality concerns. Other quality assurance and inspection measures will continue to address these areas. Plants are required to validate their own HACCP plans--that is, ensure that the plans do what they were designed to do. FSIS will not approve HACCP plans in advance but will review them for conformance with the final regulations.
The largest plants, those with 500 or more employees, are required to have HACCP systems in place by January 26, 1998. Large plants account for approximately 75 percent of slaughter production and 45 percent of processed products production. Small plants, defined as having 10 or more employees, but fewer than 500, are required to implement HACCP by January 25, 1999. Very small plants, with fewer than 10 employees or annual sales of less than $2.5 million, must implement HACCP by January 25, 2000. FSIS is encouraging plants to implement HACCP even before the regulatory deadlines.
2. Performance Standards for Salmonella
FSIS believes that HACCP systems must be combined with performance standards as a means of establishing the degree of protection HACCP systems must achieve. FSIS already has in place microbiological performance standards for ready-to-eat and other processed products, but such standards for raw products did not previously exist. The exception is the current "zero tolerance" for the pathogen E. coli O157:H7 in raw ground beef.
As part of the final rule, FSIS has established performance standards for Salmonella that slaughter plants, and plants that produce ground products, must achieve. The implementation dates for the standards correspond to the implementation dates for HACCP. Salmonella was selected because it is a major pathogen of concern, is present on virtually all classes of raw food products in numbers large enough to detect, and current methods are available to test for the pathogen. FSIS expects that reducing the percentage of carcasses with Salmonella will lead to a reduction in other pathogens as well.
Performance standards for Salmonella are based on the current national baseline prevalence for Salmonella for each major species and product class. FSIS intends to revise its performance standards for Salmonella periodically, as new data become available, to further reduce the risk of foodborne illness. FSIS will be conducting the Salmonella testing for slaughter establishments and establishments that grind products to determine whether they are meeting the pathogen reduction performance standards. The Agency will require corrective action when establishments are not meeting the standards.
Salmonella testing data will be available in accordance with the requirements of the Freedom of Information Act. In all cases, FSIS will provide an explanation of the purpose of the testing and the meaning of the data when data are provided. FSIS has no specific plans to post the data on its Web site but intends to publish for public release an annual report on the Salmonella testing.
3. Sanitation Standard Operating Procedures (SSOPs)
A sanitary environment is a basic prerequisite for preparing safe food. As of January 27, 1997, all plants were required to have in place a written plan--called Standard Operating Procedures--to address sanitation. The new rule does not impose new sanitation requirements. Instead, it institutes a process to ensure better compliance with existing Federal sanitation requirements that focus on preventing direct product adulteration.
Under the plan, each plant must describe all procedures it conducts daily to ensure effective sanitation, both before and during operations. Plants are also responsible for detecting, documenting, and correcting sanitation deficiencies and using that information to strengthen their sanitation control systems to prevent similar problems in the future.
SSOPs, while developed and maintained by the plant, will serve as an important inspection tool. They encourage individual inspectors to focus their sanitation verification on the oversight of the plant's SSOPs. Inspectors will continue to look for and require the correction of problems after they occur. FSIS will verify that the SSOPs are maintained and effective, and will take appropriate action if a plant fails to comply with the SSOP requirements. Since January 1997, FSIS has temporarily withheld the mark of inspection from about 20 plants and has moved to withdraw inspection from one plant, based on violations of the SSOPs.
4. Testing for Generic E. coli
Since January 1997, slaughter plants have also been required to test carcasses for generic E. coli as an indicator of the adequacy of the plant's ability to control fecal contamination, the primary avenue of contamination for pathogenic microorganisms. Generic E. coli is present in animal feces and, thus, is a good proximate indicator of fecal contamination.
FSIS has adopted performance criteria for E. coli for each species of animal that reflect the frequency and levels the microorganism on carcasses according to FSIS nationwide baseline surveys. FSIS is using the term "criteria" because they are guidelines, not regulatory standards. FSIS will not use the test results by themselves to take any regulatory action, but will consider them in conjunction with other information to evaluate whether a problem exists that requires regulatory action including plant closure. The required frequency of E. coli testing is based on production volume.
The original baseline surveys and performance criteria for generic E. coli published in the final rule were based on the excision method of removing meat from carcasses for testing. FSIS is now conducting new baseline surveys using a nondestructive sponge sampling technique for swine, cattle, and turkeys. Plants using the sponge method to sample carcasses must evaluate their own results using statistical process control. FSIS will make available interim criteria for use in evaluating sponge samples until final criteria can be set. FSIS intends to update the E. coli criteria periodically, based on future surveys and data generated by the testing, to ensure that the criteria reflect an appropriate and adequate level of performance with respect to prevention and removal of fecal contamination.
Implementation of the Pathogen Reduction and HACCP rule requires a significant change in the roles and attitudes of both inspectors and industry. In the past, some plants have relied on inspectors to identify deficiencies before the company would take action to correct them. Implementation of HACCP clarifies the respective roles of industry and FSIS. Businesses that produce food are accountable for its safety. They need to look at all the things that could possibly go wrong, ensure their systems prevent those problems, and take immediate action if a problem arises.
FSIS' role is to set appropriate food safety standards, maintain vigorous and continuous inspection oversight to ensure those standards are met, and take enforcement action when standards are not met through system failures. By clarifying the respective roles of industry and government, the Pathogen Reduction and HACCP rule sets the stage for enabling FSIS to better target inspection and oversight on the most significant food safety hazards.
Under the new system, instead of focusing only on individual problems in plants, FSIS inspectors and compliance personnel will evaluate whether plant systems are working as intended to prevent and control contamination. FSIS regulatory personnel will carry out the following oversight responsibilities:
Evaluation - To determine that each plant's SSOPs and HACCP plan conform with regulatory requirements.
Verification - To determine, on an ongoing basis, that a plant is carrying out its SSOP and HACCP plan, including microbial verification.
Documentation - To prepare written material to document failure to meet regulatory requirements.
Enforcement - To take appropriate actions when a plant is not in conformance with established regulatory requirements.
The conceptual shift embodied in HACCP, in which industry must assume its proper responsibility for food safety, enhances the importance of an effective enforcement program. The Agency's goal is to address plant problems at early stages, making it unnecessary for FSIS to intervene to withhold the marks of inspection for any extended period.
FSIS has established a new strategy for enforcement to complement the new rule and to provide a high level of public confidence. Under the new system, FSIS has established a link between a plant's ability to control processes and the eligibility of products to bear the marks of inspection. In other words, FSIS will base its obligation under the law to finding that product is not adulterated on the continuous demonstration that the plant sanitation and process control systems are working to prevent adulteration. Under traditional inspection, the finding that product was not adulterated was based on inspectors examining products to catch evidence of contamination.
FSIS has integrated its compliance staff into the field regulatory staff and assigned new roles to compliance officers to create a team approach to enforcement. In the past, compliance officers were primarily responsible for products in distribution channels and generally contacted plants only when following up on violations involving products that had already been distributed in commerce. Under the HACCP system, compliance officers, under the direction of the appropriate district office, are assisting inspectors in documenting failures of plant control systems and helping to ensure appropriate due process when enforcement actions are needed, including suspending the use of the inspection marks and formally closing plants, i.e., withdrawing inspection.
Reliable and accurate record keeping are critical to this new enforcement approach. Adequate records are necessary for the plant to verify that their control measures have worked and that their products are safe and wholesome. Inspectors rely on review of plant records, in addition to inplant observations, to assess whether systems are functioning properly. FSIS will pay particular attention to plants recordkeeping activities. Due process measures include notice of deficiencies, opportunity to comply, and opportunities to appeal to ensure that actions are fair and consistent and that business operations are not disrupted unnecessarily.
FSIS has carried out a number of activities to prepare for the implementation of the Pathogen Reduction and HACCP rule.
Assistance to plants - FSIS has targeted extensive technical assistance to small plants to assist them in meeting the requirements of the final rule. FSIS has targeted small plants in particular because many are not familiar with HACCP. FSIS has made available to the industry many technical guidance materials--including the draft Guidebook for the Preparation of HACCP Plans, the Meat and Poultry Hazards and Control Guide, and draft generic HACCP models for 13 products and processes. FSIS has also set up toll-free phone lines for assistance, is facilitating demonstration projects around the country to help small and very small plants to better understand and apply the new requirements, and has held numerous meetings around the country to find out from plants what information they need and how to strengthen lines of communication.
Training - FSIS is conducting extensive technical and culture change training to ensure that inspectors and other regulatory personnel are trained in time for the various implementation dates. Thus, inspectors in the largest plants are receiving training in HACCP first.
Reorganization - FSIS has made extensive changes in its organizational structure to prepare for implementation of the Pathogen Reduction and HACCP rule. The reorganization streamlined management and administrative structures at headquarters and in the field while maintaining a frontline workforce capable of providing rigorous regulatory oversight. It unified four separate field structures into one structure to carry out all domestic and international meat, poultry, and egg product inspection and compliance activities. The new organization provides new scientific focus, leadership, and expertise in addressing the most important public health risks related to meat, poultry and egg products. It also centralizes the management of all policy, rulemaking, and program development activities to better lead and evaluate program changes.
Regulatory Reform - FSIS is reforming its existing regulations to be consistent with HACCP principles, to shift to a greater reliance on performance standards, and to remove unnecessary regulatory obstacles to innovation. For example, FSIS has eliminated the prior approval requirement for facility blueprints and equipment. In addition, the Agency is merging the meat and poultry sanitation regulations into one document and simplifying them to be more compatible with the SSOP requirements. FSIS is also setting performance standards to replace the current "command-and-control" requirements.
FSIS's goal is to focus its effort on addressing the true human health risks associated with meat, poultry, and egg products. This is accomplished by using a farm-to-table approach to microbial risk assessment to identify significant food safety hazards and identify potential strategies to prevent, reduce, or eliminate those hazards. The application of risk assessment techniques to microbial pathogens poses certain challenges which differ from chemical, environmental, or toxicological risk assessments because bacterial populations can change throughout the food continuum. FSIS will use the information from risk assessments to develop efficient risk management policy options and to identify future research needs. FSIS is working with other agencies and institutions to develop appropriate quantitative risk assessment methods and to support studies to fill data gaps needed to enhance the precision and reduce the uncertainty in risk characterizations.
Even with the Pathogen Reduction and HACCP rule, food handlers must continue to handle and cook meat and poultry safely at home and in restaurants. FSIS carries out a comprehensive education program for consumers about how to handle food safely. Through campaigns, partnerships, educational materials, and a toll-free Meat and Poultry Hotline, consumers are encouraged to cook foods thoroughly, clean anything that touches raw meat or poultry, and refrigerate leftovers promptly.
To obtain paper or diskette copies of the final rule, contact:
National Technical Information Service (NTIS)
U.S. Department of Commerce
5285 Port Royal Road
Springfield, VA 22161
Orders must reference NTIS accession number PB96-177613 for a paper copy and PB96-502166 for the diskette version. For telephone orders or for further information on placing an order, call NTIS at (703) 487-4650 for regular service or (800) 553-NTIS for rush service.
For Internet access to the Federal Register, contact GPO at: www.access.gpo.gov/su_docs/aces/aces140.html
For information on ordering the following documents, contact the FSIS Public Outreach and Communications Office at (202) 720-9352 or FAX (202) 720-9063:
Generic HACCP Models
Guidebook for the Preparation of HACCP Plans
Hazards and Preventive Measure Guide -- designed to help a plant's HACCP team conduct a hazard analysis
| Technical Inquiries: | (202) 205-0699 |
| Media Inquiries: | (202) 720-9113 |
| Congressional Inquiries: | (202) 720-3897 |
| Constituent Inquiries: | (202) 720-8594 |
Consumer Inquiries:
Call the USDA's Meat and Poultry Hotline at 1-800-535-4555; in
the Washington, DC area, call (202) 720-3333.
FSIS Web site: http://www.fsis.usda.gov/, under the section "HACCP Implementation"
International HACCP Alliance: an organization representing all segments of the industry, it fosters the development of HACCP systems from farm to table.
Texas A & M University
College Station, TX 77843-2259
phone: (409) 862-2036; FAX (409) 862-3075
Web site: http://ifse.tamu.edu/haccpall.html
HACCP Training and Resource Materials Database: The Food and Nutrition Information Center at the National Agricultural Library maintains the USDA/FDA HACCP Training Programs and Resources Database, which provides up-to-date listings of HACCP training programs, resources, and consultants offering training programs or resources.
The searchable database can be accessed through the FSIS Web site at http://www.fsis.usda.gov/, under the section "HACCP Implementation."
Technical Service Center:
The FSIS Technical Service Center will operate a HACCP telephone hotline with coverage from 6:00 a.m. to 6:00 p.m.central time, Monday through Friday. The HACCP Hotline will remain in operation as long as a need exists.
The HACCP Hotline will not handle industry appeals of inspection-related decisions. All such appeals must be directed to the appropriate District Office.
The toll-free number is 1-800-233-3935 (press "2" to connect to the HACCP Hotline). Inquiries may be sent by FAX to 1-402-221-7438, or they may be sent to e-mail: HACCP.Hotline@usda.gov
Slightly Revised January 29, 1998
For Further Information Contact:
FSIS Congressional and Public Affairs Staff
Phone: (202) 720-3897
Fax: (202) 720-5704