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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
July 1998
The Food Safety and Inspection Service (FSIS) is committed to the fundamental improvements in the safety of the meat and poultry supply the American public has demanded. An essential first step in achieving that goal was accomplished with publication in the July 25, 1996, Federal Register, of the final rule on Pathogen Reduction and Hazard Analysis and Critical Control Point (HACCP) Systems. The rule requires plants to implement science-based process control systems as a means of preventing food safety hazards, sets certain food safety performance standards, and establishes testing programs to ensure those standards are met. Inspectors are assigned new tasks to enable them to ensure that regulatory performance standards are met.
During development of the final rule on Pathogen Reduction and HACCP, FSIS decided to require plants to design their process control systems around the carcass sorting process carried out by FSIS inspectors. Under the sorting process, FSIS inspectors determine which carcasses and parts are unacceptable and should be removed from the slaughter line because they are diseased or unwholesome. Now that implementation of the final rule is underway, FSIS believes it is appropriate to address the fact that under the sorting process, inspectors carry out certain process control activities that are not inspection activities and thus should be the responsibility of the plant, under FSIS oversight. This is consistent with the HACCP approach, under which plants are responsible for the production of safe and wholesome products, including carcass sorting process control activities, and FSIS is responsible for setting performance standards and ensuring those standards are met, thus ensuring that no adulterated products leave the plant.
Thus, FSIS is designing new models for inspection within plants that slaughter three specific market classes of animals to define what the Agency and the regulated industry should do when those plants are operating under HACCP. These classes of animals-- market hogs, fed cattle (steers and heifers) and young poultry (including turkeys)--comprise approximately 90 percent of the animals slaughtered in inspected establishments. These classes are composed of young, healthy animals produced under controlled conditions. FSIS is not planning to extend the new models to other classes of animals that may have more complex pathology or other problems to address.
With inspectors in these slaughter plants no longer carrying out activities that should be the plant’s responsibility, FSIS could better focus on public health concerns and further implement its farm-to-table strategy.
Specifically, FSIS believes there are additional tasks within slaughter plants, such as verification of the zero tolerance standard for fecal contamination, as well as sampling for pathogenic microorganisms and verification of HACCP systems, that deserve more focused attention than they now receive. In addition, FSIS wants to focus greater attention on products after they leave plants and enter distribution channels, where minimal attention is now paid and opportunities exist for improving food safety.
FSIS is committed to ensuring that, within plants that slaughter the target market classes of animals, the new system performs in a manner that is equivalent to or better than the current system with regard to food safety and other consumer protection activities.
FSIS will establish performance standards for those activities the plant will carry out, providing direct, on-line oversight of industry activities, and verifying the plant's overall program for producing acceptable products. FSIS will compare organoleptic and microbial data under the current system and under the models to determine the success of the models. In other words, FSIS will focus inspection resources on high priority food safety activities such as sampling for microbial pathogens, verifying zero tolerance standards for fecal contamination, and verifying HACCP systems.
The project to develop new inspection models is consistent with advice from expert groups, including the National Academy of Sciences and the General Accounting Office, that FSIS reduce its reliance on organoleptic (sight and touch) inspection, shift to prevention-oriented systems based on public health risk, and redeploy its resources in a manner that better protects the public from foodborne illness. It also is consistent with the Agency's shift toward setting performance standards that industry must meet, and conducting oversight and verification to ensure those standards are met. This provides industry with the flexibility to meet FSIS standards in a way that best suits a plant's specific operations and allows FSIS to focus more of its resources on activities that protect the public health.
Under the current inspection system in all slaughter plants, FSIS assigns inspectors to fixed stations on each slaughter line to identify, by sight and touch, diseases or defects in carcasses and parts. Some of these are related to public health, and others are not.
FSIS has identified several problems with the current system. First, by identifying diseases and defects, inspectors assume the plant’s responsibility for carcass sorting process control activities. The Agency believes it is the industry's responsibility to find defects, identify corrective actions, and solve production control problems. It is the Agency’s responsibility to set performance standards and ensure that those standards are met, thus ensuring that no adulterated carcasses or products leave the slaughter plant. In terms of organoleptic defects, FSIS believes it should set performance standards for industry to meet, just as it does with certain pathogenic microorganisms.
Second, under the current system, substantial resources are focused on detecting animal diseases or conditions. This may not be appropriate in light of the significant advances that have been made in the control or eradication of many animal diseases, particularly in the target market classes, and the increasing importance of microbial contamination as a cause of foodborne disease. In addition, the animal diseases may not be related to human disease. In particular, FSIS devotes a substantial amount of its resources to identify defects in carcasses that are related to other consumer protection concerns, such as wholesomeness.
Some organoleptic defects not related to public health, but that currently are observed by inspectors, could be handled by the plant under FSIS oversight. They include the following. In poultry plants, only inspectors check the leg joints of chickens for swelling, which may indicate the presence of the disease synovitis. Also in poultry, only inspectors look at the liver, spleen, and skin to identify lesions that indicates the presence of the virus leukosis. In cattle, only inspectors check various organs such as the liver and kidney to detect lymphoma. In swine, only inspectors look for triangular dark lesions on the skin that indicate the presence of the skin condition erysipelas. These are conditions that should be sorted out of the food supply, but do not pose a public health risk.
While these consumer protection concerns need to be addressed, input to the Agency through various public meetings and studies by expert groups has consistently supported the view that those activities that focus on public health concerns should have first priority. FSIS believes that certain activities carried out by Federal inspectors, such as those described above, should be carried out by plant personnel, thus freeing up Federal inspection resources that could be redeployed to food safety activities.
To further explore this opportunity, FSIS is presenting, for public comment, its views on which diseases and conditions in animals are related to public health, and which are not. FSIS is seeking comment on its determination of which diseases and conditions are public-health related and should properly be addressed through HACCP systems, and which could be addressed outside of HACCP systems. HACCP-Based Inspection Models Project: Diseases and Conditions Observable in Meat and Poultry is available from FSIS (see section on Documents Available on the HACCP-Based Inspection Models).
In light of the inefficiencies of the current slaughter inspection system caused by FSIS assuming industry responsibility for carcass sorting process control activities and using its resources for concerns that are not related to food safety, FSIS believes it has a responsibility to the public to reassess the current system, particularly with respect to the target market classes. The Agency is thus developing new inspection models, where appropriate, that permit it to better allocate resources according to public health risk.
The Agency is developing new models for slaughter inspection for the target market classes of animals where industry takes greater responsibility for process control--that is, where carcasses and parts that are unacceptable because they are diseased or unwholesome are removed from the slaughter line. Under the models, plants will carry out the sorting activity, and FSIS will conduct oversight and verification to ensure that current food safety and other consumer protection standards are met.
During the project, FSIS will collect objective data to determine what are the pathological, quality, and microbial characteristics of meat and poultry products produced under the current inspection system, and how these would change under the models.
FSIS has developed three slaughter models--one for young poultry (including turkeys), one for market hogs, and one for fed cattle (steers/heifers). These classes of animals were selected because they tend to be young, healthy, and uniform. The project applies only to plants that slaughter these healthy, young animals. The models describe the baseline data collection phase and the steps in the project through which plants will demonstrate their ability to match the achievements of the current system. During all steps, inspection personnel will oversee and verify plant performance.
Volunteer Plants - Only plants operating under HACCP are being included in the pilot project. As of July 1998, six plants have volunteered to participate: Jennie-O Foods, Inc., Wilmar, MN, a turkey plant; Hatfield, Inc., Hatfield, PA, a swine plant; Rocco Farm Foods, Edinburg, VA, a poultry plant; Quality Pork Processors, Austin, MN, a swine plant; Goldkist Inc., Guntersville, AL., a poultry plant; and Claxton Poultry Farms, Claxton, GA., a poultry plant. Other plants that slaughter the target market classes of animals will be added in the future.
Baseline Phase - To ensure that the new system performs in a manner equivalent to the current system, FSIS will begin collecting, in August 1998, microbial and organoleptic baseline data on the current system to provide a picture of plant performance before the models are tested. Baseline data will be collected in the Rocco and Hatfield plants initially and will be collected at other plants later. FSIS has contracted with Research Triangle Institute for baseline data collection.
All three classes of animals--market hogs, fed cattle, and young poultry—will be tested for Salmonella and generic E. coli during the baseline phase of data collection to establish current system accomplishments. Carcasses of fed cattle will also be tested for Aerobic Plate Counts (APC), which serves as a better general guide to the effectiveness of slaughter sanitation, because levels of Salmonella and generic E. coli are expected to be very low on these carcasses. FSIS is evaluating new testing methodologies to replace the costly and labor-intensive methods currently available for Campylobacter. Once a new, reliable test is available, FSIS will add Campylobacter to the sampling protocol.
Organoleptic data collected during the baseline will be used to establish a performance standard for the carcass sorting process, also referred to as the organoleptic performance rate. To arrive at this rate, carcasses will undergo the traditional inspection process, after which the decisions made using current procedures for detecting diseases and other conditions will be evaluated and recorded by technical experts.
Testing Phase - After collecting baseline data and setting organoleptic performance standards for industry to meet, FSIS, with appropriate public input, will test the models it has developed in volunteer plants and collect additional data. Testing is expected to begin in fall 1998. During the testing process, FSIS inspectors and supervisors will provide oversight and verification to ensure that all regulatory standards are met. Determination of whether a plant's slaughter process is in control will be based on its carcass organoleptic performance level and on its meeting all other regulatory standards. Plants must continue to meet the zero fecal tolerance standard, the microbial performance standards for Salmonella, and the criteria for generic E. coli that are contained in the Pathogen Reduction and HACCP final rule.
If and when slaughter plants handling the target market classes of animals assume the responsibilities being studied in this project, then Federal inspectors would be able to perform additional public health-related activities. Examples of tasks that could be performed by inspectors freed from conducting carcass sorting process control activities include the following:
Zero Tolerance Verification - FSIS believes that additional resources should be directed toward verifying that industry is meeting the zero tolerance standard for visual fecal contamination.
Verification of HACCP plans - By the year 2000, all plants will be required to have HACCP systems in place as a means of preventing contamination that can cause foodborne illness. FSIS needs to redeploy resources more evenly to verify that HACCP systems are working as intended.
Collecting Salmonella Samples - The Pathogen Reduction and HACCP rule requires slaughter plants and plants that conduct grinding operations to meet performance standards for Salmonella, and FSIS is responsible for collecting samples to verify that plants are meeting the standards. The rate of samples submitted to the FSIS laboratories by inspectors has been slower than desired, largely due to the fact that inspectors are busy performing carcass sorting process control activities. FSIS believes the collection of samples for Salmonella analysis deserves more resources. FSIS also would like to collect additional baseline data needed to develop Salmonella performance standards for raw products not currently covered under the Pathogen Reduction and HACCP rule.
Other Microbial Sampling - FSIS believes other pathogens in raw products--such as Campylobacter--might be good candidates for performance standards, and the Agency needs the resources to collect and ship samples to obtain the data needed to set additional microbial performance standards.
Campylobacter has been identified through the FoodNet foodborne disease surveillance system as the number one cause of sporadic cases of foodborne illness.
Inspection of New Plants - FSIS continues to receive demands for inspection in new plants.
The Agency's food safety strategy recognizes the need to address hazards that arise throughout the food safety continuum, from farm to table. Therefore, FSIS is also developing a plan for redeploying some inspectors currently assigned within plants to monitor, sample, and verify the safety and wholesomeness of meat and poultry in the storage, transportation, and retail sale stages of the food production chain (often referred to as the "in-distribution" stage). Activities they might perform include planned and random reviews of warehouses, product sampling at the retail level for pathogens and economic adulteration, and recall effectiveness checks. The goal is to put a flexible structure in place that can accommodate new or changing tasks that may be identified in the future.
With inspectors redeployed to monitor and sample products in the storage, transportation, and retail sale stages of the food production chain, more data can be collected about the effectiveness of food safety controls that can help the Agency determine its future food safety strategy and regulatory agenda. For example, the Agency would like to test the feasibility of verifying and enforcing temperature requirements for products in distribution. In addition, it would like to explore increasing sampling at the retail level to ensure that products continue to comply with regulatory requirements after they leave the plant.
As with other FSIS initiatives, the models are being developed through an open public process that allows all interested constituents the opportunity to participate throughout the project. The Agency is consulting closely with the subcommittee on new inspection procedures of the National Advisory Committee on Meat and Poultry Inspection, the National Advisory Committee on Microbiological Criteria for Foods, the Food Safety Consortium, and with numerous public health, industry, and consumer groups. The Agency has also consulted with the National Joint Council of Food Inspection Locals and the two supervisory associations, the National Association of Federal Veterinarians and the Association of Technical and Supervisory Professionals. Two meetings of the National Advisory Committee on Meat and Poultry Inspection included consideration of this project. All advisory committee meetings are public. FSIS also held a public meeting on the project on June 24-25, 1997, and is holding a second public meeting on July 27, 1998. Additional public meetings will be held during the various phases of the project. Once the models are tested and evaluated, FSIS will share the results with the public. Once the Agency believes it has adequate data and public input, it will go through rulemaking procedures, as appropriate and necessary, to make any final changes.
Documents Available on the HACCP-Based Inspection Models
All of the following documents are available on the FSIS Web site, at: http://www.fsis.usda.gov. Copies can also be obtained by calling the Constituent Affairs office at (202) 720-8594.
For More Information
General inquiries on the models project:
FSIS Steering committee on the HACCP-Based Inspection Model Project:
Media Inquiries: (202) 720-9113
Congressional Inquiries: (202) 720-3897
Constituent Inquiries: (202) 720-8594
Consumer Inquiries: Call USDA's Meat and Poultry Hotline at 1-800-535-4555. In the Washington, DC, area, call (202) 720-3333. The TTY number is 1-800-256-7072.
FSIS Fast Fax: 1-800-238-8281 or (202) 690-3754
FSIS Web site: http://www.fsis.usda.gov
For Further Information Contact:
FSIS Congressional and Public Affairs Staff
Phone: (202) 720-3897
Fax: (202) 720-5704