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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 |
Issue Papers
December 1997
The Pathogen Reduction and Hazard Analysis and Critical Control Point (HACCP) final rule established raw meat and poultry products performance standards for Salmonella. These apply to carcasses and raw ground products. The standards complement the process control performance criteria for fecal contamination and E. coli testing.
FSIS has selected Salmonella for microbiological testing for four reasons. First, it is the most common bacterial cause of foodborne illness. Second, FSIS baseline data show that Salmonella lives in the intestinal tract of a variety of mammals and birds. It occurs often enough to be detected and monitored. Third, current methodologies can recover Salmonella from a variety of meat and poultry products. And, finally, intervention strategies aimed at reducing Salmonella on raw product should be effective against other pathogens.
The purpose of the Salmonella performance standards is to provide incentives for producers of raw meat and poultry products to reduce the prevalence of Salmonella on their products and to provide a substantive basis for judging the effectiveness of establishments' HACCP plans by both FSIS and establishments.
There are two components to the testing program, pre-implementation testing and compliance testing.
FSIS began pre-implementation phase testing in August 1996 with a trial period to allow the laboratories, inspectors, and headquarters employees to refine the process for scheduling, collecting and analyzing samples. This enabled FSIS to provide training for employees involved, determine resources needed in the laboratories and the field and assess the processes used to collect samples and perform analyses. Official pre-implementation sampling started June 1, 1997 for large establishments. Small and very small establishments will enter pre-implementation in 1998.
Compliance testing will begin on the implementation date for HACCP as defined in the Rule for each establishment size. Large establishments will be under the HACCP Rule in January 1998, Small establishments in January 1999, and Very Small establishments in January 2000. After the year 2000, establishments will no longer be divided by size for the implementation of HACCP; all establishments will be under HACCP At that time
There are three components to the testing strategy for the Compliance phase of testing.
The enforcement policy follows the framework established by the rule.
First Sample Set - If a performance standard is not met, Headquarters will notify the District Manager. The District Manager (DM) will notify the establishment of the non-compliance and that the establishment is required to take immediate action to meet the standard. (This will be documented on a Noncompliance Report (NR).) The establishment will be scheduled for a second sample set, normally within 60 days but the schedule may change based on input from the DM requesting more rapid or less rapid action.
Second Sample Set - If a performance standard is not met, Headquarters will notify the District Manager. The DM notifies the plant citing the regulatory requirement for the establishment to reassess its HACCP plan for that product and take corrective action. This will be documented on an NR. The Establishment will be scheduled for a third sample set at a time based on the DM's recommendation. The DM will consider factors such as the establishment's progress on reassessing their HACCP plan, or performance on E. co/i process controls, or pattern of failing checks for fecal contamination.
Third Sample Set - If a performance standard is not met, Headquarters will notify the District Manager. The DM informs the plant orally and by certified letter that they have failed to maintain an adequate HACCP plan for that product in accordance with Part 417. This is documented on an NR. Inspection service for that product is suspended and will remain so until the establishment submits to the FSIS Administrator, or designee, satisfactory written assurances on actions taken to correct the HACCP System (310.25(b)(3)).
During Compliance Phase testing, any plant that is targeted and passes a sample set will return to the random pool and can then be tested at some later time in the Ongoing Random Testing.
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