|Food Safety and Inspection
United States Department of Agriculture
Washington, D.C. 20250-3700
Key Facts: HACCP Final Rule
The Food Safety and Inspection Service's Pathogen Reduction and HACCP Systems final rule mandates new measures to target and reduce the presence of pathogenic organisms in meat and poultry products. These measures include FSIS testing to verify pathogen reduction performance standards are being met, plant microbial testing to verify process control for fecal contamination, written sanitation standard operating procedures (SOPs), and mandatory Hazard Analysis and Critical Control Points (HACCP) systems in all meat and poultry plants.
Two of the four essential elements of the new food safety system involve microbiological testing:
The presence of microorganisms on raw meat and poultry is unavoidable and highly variable. Process control systems can minimize initial contamination of the carcass, remove many pathogenic microorganisms during processing, control proliferation of remaining pathogens, and minimize recontamination. Performance standards set requirements for pathogen reduction that must be met by plants that produce raw meat and poultry products. HACCP provides the framework for industry to set up science-based process controls to achieve these standards.
Salmonella was selected because it is the most common cause of foodborne illness associated with meat and poultry products. Methods aimed at reducing Salmonella can also be expected to reduce other enteric pathogens that contaminate meat and poultry.
The pathogen reduction performance standard is based on FSIS baseline survey data on the prevalence of Salmonella in raw products. All establishments must achieve the performance standard consistently over time through appropriate and well-executed controls.
The Salmonella pathogen reduction performance standards apply a uniform policy principle: all slaughter and ground product plants must achieve at least the current baseline level of performance with respect to Salmonella for the product classes they produce. This approach will begin 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 using careful process control to prevent contamination and readily available procedures to remove contamination.
FSIS will begin collecting data in slaughter plants three months after publication of the final rule. Testing will be conducted in a manner designed to provide a reliable picture of the plant's performance in relation to the applicable pathogen reduction performance standards prior to implementation of the standards.
Plants will be required to meet the applicable Salmonella standard at the same time they are required to implement HACCP, either 18, 30, or 42 months from the date of publication of the final rule, depending on the size of the plant.
The Salmonella enforcement strategy embodies an objective, uniform systems approach that will be administered and applied in a fair, equitable, and common-sense manner. The Agency will continually monitor and adjust its enforcement program and activities to reflect these principles while ensuring food safety.
If testing indicates the performance standard is not being met, FSIS will decide whether to conduct follow-up testing on the basis of several factors. If a plant with Salmonella test results marginally above the limit takes corrective action, FSIS could judge, based on the plant's actions and other factors relevant to ensuring food safety, that immediate follow-up testing is not necessary. However, if the plant with marginal results fails to take adequate corrective action, or in any case where results significantly exceed the standard, FSIS would conduct further testing.
After implementation of the standards, the frequency and intensity of testing will be determined by past plant performance, observations by FSIS inspectors, other data, and any reports of illness associated with the product produced at the plant.
The Agency's responses will increase in severity with successive failures to meet the standard, ranging from requiring the plant to take whatever action it finds necessary to prevent a recurrence, to suspending inspection pending satisfactory reassessment by the plant of its HACCP plan.
FSIS plans to consider all appropriate data in determining when and how to adjust the Salmonella standards, and possibly set standards for additional pathogens, as well.
Future reductions in the allowable incidence of contamination will more likely occur in species product classes with the highest current incidence.
FSIS is requiring testing in slaughter plants for generic E. coli to verify that the slaughter process is in control for the prevention and removal of fecal contamination. Generic E. coli was selected by FSIS because of the scientific consensus that it is useful for this purpose, because the analysis is relatively easy and inexpensive to perform and because levels can be quantified. FSIS is seeking additional scientific and technical data that may support improvements to the testing protocol.
Microbiological performance criteria, developed using data on the prevalence of E. coli from FSIS's national baseline surveys, will be available to help plants verify that their process controls are effectively preventing fecal contamination and will be used similarly by the inspectors to help them assess the effectiveness of the plant's controls. 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 will be required to begin E. coli testing six months after the final rule is published. Plants that do not test, or fail to keep records, will be subject to withdrawal of inspection. Twelve months after publication of the final rule, after plants have had an opportunity to gain experience in conducting the testing, FSIS personnel will start reviewing E. coli test results as part of their inspection routine.
Sampling frequency will be determined by the plant's production volume, from many tests per day in high volume plants, to testing once a week in the smallest plants. Slaughter plants operating under validated HACCP systems will continue to use E. coli testing to verify that their processes are controlling fecal contamination, but may use alternative frequencies.
Plants will record test results and make them available to inspectors. The performance criteria require review of a moving "window" series of test results to provide a continuous picture of plant performance. This minimizes the risk that the plant's process control will be questioned due to a chance test result, but is sensitive enough to detect when performance falls short.
FSIS will not mandate antimicrobial treatments in slaughter plants as originally proposed. However, antimicrobial treatments will likely play an important role in HACCP plans as more plants establish controls that are effective in reducing pathogens and meet FSIS performance standards.
FSIS believes that improvements in food safety are best accomplished if plants have the incentive and the flexibility to incorporate antimicrobial treatments they judge to be most suitable for their operations in meeting established performance standards.
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