FSIS Sets New Procedures for Plants That Fail Salmonella Tests
The U.S. Department of Agriculture's Food Safety and Inspection Service has issued new procedures for responding to establishments that fail Salmonella performance standard testing for raw products. The new procedures constitute a more scientific and systematic approach to food safety and to the enforcement of current regulations.
In July 1996, the landmark Pathogen Reduction/Hazard Analysis and Critical Control Point (HACCP) rule required all meat and poultry slaughter and processing plants to adopt a system of process controls to prevent food safety hazards. The rule has four components: standard operating procedures (SOPs) for sanitation, HACCP plans, generic E. coli testing and Salmonella performance standards.
Under the HACCP rule, each establishment is required to develop sanitation SOPs to demonstrate whether it is meeting all basic sanitation requirements on a daily basis. There is a direct, and substantial, link between insanitary practices in meat and poultry plants and the likelihood of product contamination by pathogenic bacteria. Meat and poultry plants document and maintain daily records of completed sanitation procedures and corrective and preventive actions and make their records available to FSIS inspectors for review and verification.
Establishments are required to implement and maintain extensive records of their HACCP plans. A plant must analyze its processes to determine critical control points (CCP) where food safety hazards might occur. Critical limits must be established as parameters for variables such as temperature, time, humidity, and pH level. Records documenting the monitoring of critical control points, critical limits, verification activities and the handling of processing deviations must also be maintained and reviewed regularly. Next, the plant must establish monitoring requirements for each CCP and corrective actions to be taken when monitoring indicates a deviation from an established critical limit. Plants must produce records to verify that control measures have worked and that their products are safe and wholesome.
In addition, establishments must conduct generic E. coli testing to verify that their process control systems are working as intended to prevent fecal contamination — the primary avenue for the introduction of this harmful bacteria. Such testing helps establishments determine how effective slaughter and sanitary dressing procedures are at preventing and removing microbial contamination.
Finally, FSIS set Salmonella performance standards to verify whether HACCP systems are effective in controlling contamination by this pathogenic microorganism. Salmonella was selected because it is a pathogen of concern and is present on virtually all classes of raw food products in numbers large enough to detect.
The four components of the PR/HACCP final rule — sanitation SOPs, HACCP plans, E. coli testing, and Salmonella performance standards — complement one another and embody a systems approach to food safety.
Supreme Beef Processors, Inc. v. USDA
In December 2001, the U.S. Court of Appeals for the Fifth Circuit handed down a decision ( Supreme Beef Processors Inc. v. USDA) prohibiting USDA from suspending inspection services based solely upon failure of the Salmonella performance standard. Despite the ruling, USDA maintains the ability to initiate a withholding, suspensions, or withdrawal action based on sanitation or HACCP violations, including: failure to collect and analyze samples for the presence of generic E. coli; failure to develop or implement sanitation SOPs; or failure to develop or implement a required HACCP plan.
USDA may also initiate a withholding, suspensions, or withdrawal action for other violations, such as inhumane slaughter or unsanitary conditions. The court's ruling did not impact USDA's ability to use the Salmonella testing results to trigger an immediate review of an establishment's entire food safety system. FSIS' new procedures emphasize using the Salmonella testing in this manner.
New Salmonella Procedures
To determine the safety and wholesomeness of meat and poultry in federal plants, FSIS conducts Salmonella testing. Enough samples are collected to make up a "set." The number of samples in a set, as well as the number of positives samples permitted, vary depending on the product.
For example, in steers and heifers 82 samples make up a set and only one sample is permitted to test positive for Salmonella. For broilers, 51 samples make up a set and 12 samples are permitted to test positive for Salmonella. FSIS conducts testing on carcasses of cattle, swine, and broilers as well as ground beef, ground chicken and ground turkey. The prevalence of Salmonella, therefore, is not determined by the number of organisms found in a sample but by the number of set failures.
The new measures for plants that fail Salmonella testing (Notice 28-02) accelerate the review of a plant's HACCP plan and involve higher level supervisors at an earlier stage than previous procedures. After the first set of samples indicate that Salmonella is being found at a frequency higher than the federal standard, the district manager will document the failure in a notification letter to the establishment, instructing it to take actions necessary for compliance. The circuit supervisor and inspection personnel will conduct an assessment of the establishment's HACCP plan and sanitation SOPs, as well as generic E. coli testing data, focusing on the establishment's planned corrective actions. The circuit supervisor and inspection personnel will develop a plan to verify corrective actions implemented by the plant. If necessary, enforcement actions, such as issuing a Notice of Intended Enforcement or suspending inspection, will be taken.
If the establishment fails a second set of Salmonella tests, the district manager will document the failure in a notification letter to the establishment, communicating that FSIS expects the establishment to reassess its HACCP plan and take corrective and preventive actions. After the plant has reassessed its HACCP plan and implemented any appropriate changes, an FSIS team that includes a consumer safety officer will conduct an in-depth verification (IDV) review. If the review identifies that a problem still exists, FSIS will either allow the plant to reassess its HACCP plan again within 30 days to ensure changes are effective, schedule a third set of Salmonella tests, or initiate enforcement action. The Consumer Safety Officer will develop a plan to verify any modifications made by the establishment in response to the second set failure.
Failure of a third Salmonella test set will require the district manager to again document the failure in a notification letter. The district manager will inform the company that a Consumer Safety Officer and a compliance officer will conduct a comprehensive assessment of the establishment's food safety systems to determine if the systems have failed to prevent, eliminate or reduce to an acceptable level the occurrence of food safety hazards. If the comprehensive assessment identifies that a problem still exists, FSIS will either allow the plant to reassess its HACCP plan again within 30 days, schedule a fourth set of Salmonella tests, or initiate enforcement action. The consumer safety officer will develop a plan to verify and address the actions taken by the establishment in response to the third set failure.
Additionally, FSIS may conduct IDV reviews at some or all suppliers of a grinding plant that repeatedly fails the performance standard.
FSIS' new procedures for responding to the failure of the Salmonella performance standard ensures a scientific approach to food safety while increasing consistency and uniformity. Establishments must ensure that all four components of the PR/HACCP final rule are working together as intended to safeguard the nation's food supply. The new procedures also emphasize coordination between consumer safety officers, district managers, circuit supervisors, compliance officers and inspection personnel to address inspection failures.
In June 2002, FSIS announced new directives instructing inspectors to determine whether grinding establishments are effectively addressing Salmonella and E. coli O157:H7 in their HACCP plans. Increased testing for these pathogens will be done in plants that do not employ effective decontamination strategies or that don't require their suppliers to do so as part of their HACCP systems.