FROM: Ken Mastracchio, Director of Regulatory Affairs

June 21, 1999

Guidance Materials for Achieving Compliance with the May 26, 1999 Federal Register Notice entitled, "Listeria monocytogenes Contamination of Ready-to-Eat Products"

FSIS’s May 26, Federal Register Notice mandated reassessment of HACCP plans for RTE product to determine if Listeria monocytogenes (LM) is a food safety hazard reasonably likely to occur. Beyond the reassessment deadline of June 25, 1999 the Notice does not identify any other specific requirements. If a manufacturer’s reassessment determines that LM is a food safety hazard reasonably likely to occur it will be necessary to apply a Critical Control Point. Most likely the CCP will address post cooking recontamination situations such as those found in slicing and packaging operations. Manufacturers of product cooked in hermetically sealed bags or product with a Aw of less than 85 or a pH of less than 4.5, may conclude that LM is not a hazard reasonably likely to occur.

The regulatory content of the Notice recognizes the significance of SSOPs as a type of precursor of HACCP in addressing instances of direct product contamination. In essence the Notice is stating that with the implementation of HACCP these SSOPs should be transferred into role of addressing post process contamination hazards from LM. These transformed CCPs may consists of SSOPs which previously dealt with the monitoring of employee hygiene and or product handling procedures.

At an Agency briefing an FSIS spokesperson discussed three possible scenarios involving inspection personnel applying reassessment verification. They are:

1) Inspection personnel may issue NRs if plants have not conducted reassessment and have received positive lab results for LM within the last 3 or 4 years. Plants with no history of Listeria monocytogenes will be given verbal instructions to reassess.

2) Inspection personnel may issue an NR if plant has had positives for LM on either product or product contact surfaces and has not conducted a reassessment of their HACCP plan.

3) Inspection personnel will conduct verification procedures 01 and 02 only for plants that have modified their HACCP plan based on their reassessment.

On Friday, June 25, 1999 inspection personnel will begin their verification tasks in order to determine compliance with the Notice. An FSIS source has indicated that the Agency is looking for evidence that plants are making a good faith effort in conducting their reassessment. The source further stated that written guidelines, which convey the essence of a good faith effort, may be provided to inspection personnel.

Before addressing the reassessment guidelines we wish to reemphasize the following points:

1) Plants that conduct their reassessment in a good faith effort will be considered in compliance with the Notice and be granted a reasonable amount of time to conduct data collection.

2) The Agency recognizes the role of micro testing as a tool for verification and not as a CCP.

3) The Agency will recognize the "safe harbors" for cooking times and temperatures provided in Appendix A of the Federal Register Final Rule entitled, "Performance Standards for the Production of Certain Meat and Poultry Products."

4) The Agency is concerned with raw materials in handling and storage from the time of receipt to cooking and the impact on LM levels.

5) In any reassessment document the word ‘Listeria monocytogenes’ should be stated.



Reassessment guidelines:


1. The hazard analysis (HA) was reassessed to address the potential presence of Listeria monocytogenes (LM) in incoming raw materials and as a food safety hazard in ready-to-eat products. The agency’s position is that it considers LM to be a food safety hazard reasonably likely to occur, in which case it requires a critical control point (CCP) to control it. When reassessing the HA, plants are advised that any past findings of LM on products by FSIS or internal plant testing would virtually ensure that the agency will be expecting a CCP for post-cooking control of LM. In the absence of past findings, plants may be able, with sufficient documentation/data, to demonstrate that post-cooking re-contamination is not "reasonably likely to occur." In this case, the plant may conclude that an additional CCP is not required.

The exposure to contamination after the lethality treatment must be evaluated and documented. This activity includes several points:

a) Requires establishments to evaluate equipment design or operation.

b) Requires establishments to identify post-processing contamination sites (i.e. places for cross-contamination due to people, equipment and product flow; separation of raw and cooked areas, etc.).

c) Requires establishment to consider finished product characteristics such as water activity, pH, and the presence of one or more barriers that inhibit pathogen growth.

Finally, evidence of product contamination (i.e. effectiveness of system) should be evaluated. This may include microbiological test data for product contact surfaces or finished products.

2. The reassessment was documented and supporting materials were attached.

3. The HACCP plan was modified as needed based on the reassessment of the HA, and it was signed and dated, accordingly.

4. Incoming levels of LM were addressed, either through raw material testing or by using the national baseline data included in the Guidance Materials for Industry provided by FSIS. The plant’s handling procedures for raw materials (i.e. opportunity for LM growth during raw material storage) must be considered.

5. Kill step (i.e., cooking process) was validated by:

a) Use of challenge studies, scientific literature, computer modeling programs, expert advice from processing authorities OR

b) Using the "Compliance Guidelines for Meeting Lethality Performance Standards for Certain Meat and Poultry Products (Appendix A)." While the agency has not identified the times/temperatures in this document as guaranteed safe harbors, it has stated that it considers them validated to provide adequate lethality in "normal" situations.

6. Application of validated kill step was verified under actual in-plant conditions. This can be done by collecting data on cooking times and temperatures to document that the process actually delivers the desired conditions. Document all data collected during this period.

Note: Please see the "Guidelines for Developing Good Manufacturing Practices (GMP’s), Standard Operating Procedures (SOP’s) and Environmental Sampling/Testing Recommendations (ESTR’s) are available at


Thanks to Southwest Meat Association for information on this reassessment.