Legislative

New, improved Lm sampling program arrives

January 11, 2013

On Dec. 19, 2012, the Food Safety and Inspection Service (FSIS) issued Notice 73-12 implementing changes in the agency’s two robust Listeria monocytogenes (Lm) sampling programs. This notice is the last of a series of issuances designed to improve Listeria control at establishments and increase sensitivity of FSIS product samples.

In September 2012, FSIS issued a Federal Register Notice announcing changes to FSIS’ procedures for product sampling under the agency’s Routine Risk-based Listeria Monocytogenes (RLm) Sampling Program and its Intensified Verification Testing (IVT) program.

  • FSIS will increase the number of Lm product samples it collects under both programs from three to five individual product samples.
  • With respect to the RLm program only, the FSIS laboratory will composite the five 25-g product samples into a single 125-g analytical sample.
  • With respect to the IVT program only, FSIS will not composite the five 25-g samples, but will analyze each of the five samples separately.

In all other regards, these FSIS verification programs remain unchanged. FSIS made these changes because they would: (1) be more consistent with international practices; (2) conserve laboratory resources; and (3) most importantly, increase the potential for detecting positive Lm product samples.

In the recent Notice 73-12, FSIS instructed its Enforcement, Investigations and Analysis Officers (EIAOs) to implement the sampling changes above on Jan. 2, 2013. The notice also instructs the EIAO to select products from the highest risk alternative at the establishment, e.g., select from Alternative 3[1] if products are produced under Alternatives 3 and 2. The notice also contains a chart setting forth the risk ranking of various products. The EIAO is to select the product with the highest risk level.

With regard to the less robust random sampling programs (ALLRTE and RTE001), the notice instructs in-plant inspectors to use the risk rankings in selecting routine Lm product samples. However, only a single two-pound sample is to be collected, and it will not be composited.

Bottom line: The new sampling schemes will increase the likelihood of finding Lm positive product. For this reason, an establishment making ready-to-eat product would be well advised to review, and make any necessary changes to, its Listeria control program.

To assist in this review, FSIS has made available a revised draft Compliance Guideline for establishment Listeria control. There are no major changes to previous recommendations, but it has been reformatted into four chapters and contains additional information. Key expansions include:

  • A new appendix (Appendix 2.1) on validation of post-lethality treatments and antimicrobial agents;
  • A detailed description of the types of escalated actions that establishments can take during intensified cleaning and sanitation following positive Listeria samples;
  • A new appendix (Appendix 2.3) on suggested employee training programs for Listeria control;
  • FSIS’ expectations for establishment Listeria sample collection and laboratory analysis; and
  • Recommendations for identifying and addressing Listeria trends at the establishment.

With the odds going up that FSIS may detect Lm in a product, it is time for establishments to ensure they are at the top of their game.



[1] 3 Alternative 3 is considered the highest risk because the establishment relies exclusively on its sanitation program to control Lm contamination in the processing environment and on the product.

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