FSIS Microbiological Testing Program for Ready-to-Eat (RTE) Meat and Poultry Products: Timeline (Changes to the program)
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Ready-To-Eat Timeline (Changes to the program):
1983-2004—Establishments were randomly selected for regulatory samples from different sub-populations or from the total population of establishments producing RTE products.
2005—FSIS implemented RTE001, a new project aimed at selecting establishments for sampling based on different risk factors for Lm. RTE001 is described in 2005 results.
2006—FSIS implemented RLm, phase 2 of Lm risk-based sampling program. RLm includes sampling of products, product contact surfaces, and environmental surfaces in conjunction with a comprehensive Food Safety Assessment (FSA). FSIS Directive 10,240.5 (February 3, 2009) provides direction to Enforcement, Investigations, and Analysis Officers (EIAOs) and Public Health Veterinarians (PHVs) trained in the EIAO methodology for collecting samples under the RLm sampling project. RLm samples are analyzed only for Lm.
2007—FSIS modified RTE001 after an incident where an unusual proportion of a product using growth inhibitors was found to be Lm positive. The risk-based algorithm was adjusted to ensure that more products using antimicrobials or growth inhibitors were sampled. During April of the same year, FSIS modified the algorithm to ensure that 50 percent of the samples each month were scheduled in establishments reporting production of products with an antimicrobial or growth inhibitor but without any post exposure pasteurization (i.e., Alternative 2b products). The algorithm directed the majority of samples to establishments using sanitation alone to control Lm in RTE products (i.e., Alternative 3). For more information of post lethality alternatives please see 9 CFR 430.3. There is no way to assess what effect this modification had on the overall CY 2007 results for RTE001.
2009—In August, FSIS began compositing the five environment samples taken as part of the RLm sampling program to allow FSIS to increase the number of establishments scheduled each month from 15 to 45.
In establishments selected for non-RLm testing, the inspection program personnel (IPP) send a sample request form identifying the sampling project, the microbial hazard(s), and the FSIS laboratory where the analysis will take place. The form also identifies a window of time to collect a sample. FSIS Directives contain additional guidance for how to select the product for sampling. After identifying the product or product category, IPP randomly select the sample. All samples (except RLm) are analyzed for Salmonella and Lm.
The product resulting in a positive sample must be reprocessed or destroyed. Most establishments voluntarily hold all RTE product pending notification of the FSIS laboratory test results. If all product implicated by a positive laboratory result is not under the establishment's control, then the producing establishment must take steps to remove adulterated product from distribution channels and/or commerce, which may entail a voluntary recall.
Starting in CY2004, FSIS revised the terminology it uses to describe RTE microbiological testing program results. FSIS now reports results as both the number and percentage of analyzed samples that have tested positive for Salmonella or Lm. Previous postings described these results as "prevalence." However, the term "prevalence" may imply that results from the regulatory sampling projects are statistical estimates of national product prevalence. To avoid confusion, FSIS will now only use "prevalence" to describe testing results from nationwide baseline studies specifically designed to provide statistically valid baseline estimates of national product prevalence for various microorganisms and for regulatory purposes. Results of regulatory testing projects conducted to verify the effectiveness of food safety systems are reported as the percent of analyzed samples that tested positive.