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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 |
Key Facts: HACCP Final Rule
Revised January 1998
Since a major outbreak of foodborne illness in several western states in 1993 attributed to the presence of the pathogenic bacterium E. coli O157:H7 in ground beef, USDA’s Food Safety and Inspection Service (FSIS) has focused on the design and implementation of a science-based food safety strategy to reduce the risk of illness caused by bacterial contamination of meat and poultry products.
The Centers for Disease Control and Prevention estimate that as many as 4,000 deaths and 5 million illnesses result annually from the consumption of meat and poultry products contaminated with four major bacterial pathogens: Salmonella, Campylobacter, E. coli O157:H7, and Listeria monocytogenes. These deaths and illnesses may be reduced, but may not be totally preventable through actions that can be taken throughout the farm-to-table food safety chain to prevent, reduce, and eliminate harmful bacteria.
The Clinton Administration moved quickly following the 1993 outbreak to mandate safe handling labels for raw meat and poultry products, declare E. coli O157:H7 an adulterant on raw ground beef, initiate a testing program for that pathogen, and encourage the development and use of new technologies to reduce harmful bacteria during slaughter and processing. FSIS also has designed a completely new food safety regulatory system to target and reduce harmful bacteria in meat and poultry and modernize the 90-year-old USDA inspection program. On July 6, 1996, President Clinton announced that the final rule on Pathogen Reduction and HACCP (Hazard Analysis and Critical Control Points) was ready to make this new regulatory system a reality.
As of January 27, 1997, all plants were required to adopt and carry out written Sanitation Standard Operating Procedures (SSOPs) to prevent sanitation problems, such as unclean equipment or poor worker hygiene, that can contribute to contamination of finished products with harmful bacteria. The traditional system relied too heavily on government inspectors to detect and correct sanitation problems after they occurred rather than focusing on the plant’s responsibility to prevent such problems from occurring in the first place.
All plants are required to adopt the system of science-based process controls known as HACCP (Hazard Analysis and Critical Control Points) to identify and prevent the specific food safety hazards associated with each product and production process. HACCP requires slaughter plants to target bacterial hazards and to demonstrate the effectiveness of their HACCP plans in addressing such hazards. HACCP harnesses currently available technologies that can significantly reduce bacterial contamination.
Effective January 26, 1998, all large plants (500 or more employees) implemented a HACCP plan. Small plants (10 or more employees but fewer than 500) must meet this requirement by January 25, 1999; and very small plants (under 10 employees or annual sales of less the $2.5 million) will come under HACCP by January 25, 2000.
All slaughter plants are required to regularly test carcasses for the generic form of E. coli to verify that their control systems are working to prevent fecal contamination. Generic E. coli is the best microbial indicator of fecal contamination, which is the primary pathway for contamination of meat and poultry with enteric (or intestinal) bacteria, such as Salmonella, Campylobacter, and E. coli O157:H7.
Testing for generic E. coli is relatively easy and inexpensive to perform, and the levels can be quantified. FSIS is seeking additional scientific and technical data that may support improvements to the testing protocol.
Microbiological performance criteria were developed using data on the prevalence of E. coli from FSIS’s national baseline surveys.
The criteria are not enforceable regulatory standards but are intended to provide an objective point of reference that will help slaughter plants and FSIS ensure that plants are meeting their obligation to prevent and reduce fecal contamination of meat and poultry products.
Plants were required to begin E. coli testing on January 27, 1997. Plants that do not test, or fail to keep records, have been subject to withdrawal of inspection. On January 26, 1998, FSIS personnel began reviewing E. coli test results as part of their inspection routine. Sampling frequency will be determined by the plant’s production volume. Plants must record test results and make them available to inspectors.
Slaughter plants and plants that produce raw ground products must meet pathogen reduction performance standards for Salmonella. Salmonella is the leading cause of foodborne illness among the enteric pathogens, and measures taken by plants to prevent and reduce Salmonella contamination may also reduce contamination with other enteric pathogens, such as E. coli O157:H7 and Campylobacter.
Salmonella was selected as the performance standard due to its prevalence in raw meat and poultry products and the availability of reliable laboratory tests to isolate the pathogen.
In September of 1996, FSIS began a comprehensive Salmonella testing program in slaughter plants to measure plant performance with respect to Salmonella on their products. All plants will be required to meet the Salmonella performance standard by January 26, 1998, and plants that do not meet the performance standards will be required to achieve the performance standard consistently over time through appropriate and well-executed controls.
The pathogen reduction performance standard is based on FSIS baseline survey data on the prevalence of Salmonella in raw products. All plants involved in animal slaughter and the processing of ground product must achieve at least the current baseline level of performance with respect to Salmonella for the product classes they produce. This approach begins necessary progress on pathogen reduction across all species while FSIS continues data collection and other efforts to refine its performance standards.
Plants can meet the pathogen reduction standard for Salmonella by developing and using effective process controls to prevent contamination and by incorporating readily available procedures in the event it does occur.
Plants are required to meet the applicable Salmonella standard at the same time they are required to implement HACCP.
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