UNITED STATES DEPARTMENT OF AGRICULTURE
FOOD SAFETY AND INSPECTION SERVICE
WASHINGTON, DC

FSIS NOTICE 23-99 8-3-99

Instructions for Verifying the Listeria monocytogenes Reassessment

On June 17, 1999, the Agency issued FSIS Notice 17-99, Listeria monocytogenes Reassessment. The notice provided inspection program employees with a copy of the Federal Register notice, Listeria monocytogenes Contamination of Ready-to-Eat Products and information regarding the need for manufacturers of ready-to-eat (RTE) livestock and poultry products to reassess their HACCP plans for these products as specified in 9 CFR 417.4(a)(3). The notice also stated that FSIS would issue instructions for the verification of the Listeria monocytogenes reassessment.

GENERAL INFORMATION

Inspection program employees verify that establishments have begun conducting a reassessment with respect to Listeria monocytogenes under ISP activity codes 03E01, Not Heat Treated-Shelf Stable; 03F01, Heat Treated-Shelf Stable; 03G01, Fully Cooked-Not Shelf Stable; or 03I01, Product with Secondary Inhibitors-Not Shelf Stable. PBIS schedules these activities. After receiving this notice, inspection program employees should perform the verification when PBIS schedules the next 01 procedure.

Establishments are not required to develop written documentation for the reassessment, and they can reassess in a number of ways. Inspection program employees verify that the HACCP-trained individual conducted the reassessment (see 417.4(a)(3)). For example, the HACCP- trained individual may meet with inspection program employees to inform them of his or her determination, which may be that Listeria monocytogenes is not a hazard reasonably likely to occur because the establishment has no history of Listeria monocytogenes, (e.g., routine testing results have been negative). Another establishment may have the HACCP-trained individual write a revised hazard analysis indicating the same determination. Note: It is not necessary for an establishment to reassess if it already has validated controls in its HACCP plan that specifically address lethality and post processing hazards related to Listeria monocytogenes, and such controls are monitored and verified on an ongoing basis.

It is not a requirement that establishments incorporate testing programs for Listeria monocytogenes into their HACCP plans or Sanitation SOP’s. If establishments have environmental sampling plans for Listeria monocytogenes or Listeria ssp. incorporated into their Sanitation SOP’s, inspection program employees verify that establishments are following such plans by performing a 01 or 02 Sanitation SOP’s procedure. Note: Establishments must conduct corrective actions for any positive results for Listeria monocytogenes on a RTE product sample as specified in 417.3.

The following are instructions for how to proceed in verifying that establishments conducted the reassessment:

FAILURE TO PERFORM REASSESSMENT

If inspection program employees determine that the establishment has not reassessed its HACCP plan and that:

  1. product is exposed to the environment after the lethality step and there is a history of positive results for Listeria monocytogenes product samples either from establishment or FSIS testing, or

  2. there are findings of product contact surface positives for Listeria monocytogenes without follow-up product actions,

they document a noncompliance using the "verification" trend indicator and reference the Federal Register notice on the FSIS Form 5400-4, Noncompliance Record (NR). Also, they perform the appropriate HACCP 02 procedure on the production for which the HACCP 01 was conducted to verify that all critical limits were met through monitoring or verification of the HACCP plan, and that Sanitation SOP’s requirements were met as they relate to that specific production. Inspection program employees should focus upon the establishment’s immediate and further planned action in response to the HACCP 01 noncompliance on the NR. Inspection program employees inform the circuit supervisor of the response.

If inspection program employees determine that the establishment has not reassessed its HACCP plan, and that the establishment does not have a history of Listeria monocytogenes on product, they do not take immediate action. At the weekly PBIS meeting, inspection program employees remind the establishment that the reassessment must be done and refer them to the Federal Register notice. If after the meeting, the establishment fails to begin its reassessment, inspection program employees note this on the bottom of the Procedure Schedule. The District Offices will review the Procedure Schedule and take the appropriate follow-up action and notify inspection program employees accordingly.

REASSESSMENT WITHOUT MODIFICATION TO THE HACCP PLAN

If an establishment performed a reassessment and concluded that the HACCP plan did not need modification, inspection program employees take action only if:

  1. product is exposed to the environment after the lethality step and there is a history of positive Listeria monocytogenes product samples or

  2. there are findings of product contact surface positives for Listeria monocytogenes without follow-up product actions.

In this situation, inspection program employees document a noncompliance using the "verification" trend indicator. Inspection program employees perform the appropriate HACCP 02 procedure on that specific production to verify that all critical limits were met through monitoring or verification of the HACCP plan, and that SSOP requirements were met as they relate to the specific production. Inspection program employees focus upon the establishment’s immediate and further planned action response to the HACCP 01 noncompliance on the NR. Inspection program employees inform the circuit supervisor of the response. Note: Establishments are required to reassess, not develop critical control points.

REASSESSMENT WITH MODIFICATION TO THE HACCP PLAN

If an establishment performed a reassessment and concluded that the HACCP plan needed modification, inspection program employees verify the modification

to the HACCP plan through performance of 01 and 02 HACCP inspection procedures. Note: Signed and dated modifications to the HACCP plan must be done in accordance with 417.4(a)(3).

OTHER DETERMINATIONS MADE AS PART OF REASSESSMENT

As part of the reassessment, establishments may determine that products need to receive a lethality treatment (i.e., be cooked) by the intended user. Such product would be considered not-ready-to-eat (NRTE) and would need to be processed under the appropriate processing category (9 CFR 417.2(b)). The attached chart (Attachment 1) provides information that distinguishes RTE product from NRTE product.

For technical guidance contact the TSC. For guidance related to regulatory activities refer questions through supervisory channels.

 

/s/ Philip S. Derfler

 

Deputy Administrator
Office of Policy, Program Development and Evaluation

Attachment 1

DISTRIBUTION: Inspection Offices;
T/A Inspectors; Plant Mgt; T/A Plant
Mgt; TRA; ABB; PRD; Import Offices

 

 NOTICE EXPIRES: 8-1-00 OPI: OPPDE

 

Attachment 1

Inspection program employees should be aware that an establishment, as part of its reassessment, might make the following determinations. Inspection program employees should refer any questions to the TSC.

TYPE CLASS PROCESSING CATEGORY ISP CODE REG REQUIRED SAFETY LABELING WHAT THE HAZARD ANALYSIS/HACCP   PLAN MAY ADDRESS
A product containing a meat/poultry product (in whole or in part) which has not received an adequate lethality treatment for pathogens (i.e. raw or partially cooked product).  

NRTE
  • Raw Product Ground - ISP 03B
  • Raw Product Not Ground – ISP 03C
  • Heat Treated but not Fully Cooked Not Shelf Stable - ISP 03H
  • Products with secondary inhibitors Not Shelf Stable – ISP 03I
 Product must be labeled with statements such as keep refrigerated or frozen. Use of Safe Handling Instruction (SHI) labeling required.
  • Use of SHI labeling (Some establishments may have a CCP for SHI labeling application).

If it is not obvious that the product is raw and needs to be cooked:

  • Features on labeling are conspicuous so that intended user is fully aware that product must be cooked for safety. This is best conveyed through the product name (e.g., "Cook and Serve") but may also be conveyed by the use of an asterisk on the product name that is associated with a statement on the principle display panel, or by a burst stating such things as "needs to be fully cooked," "see cooking instructions," or "cook before eating."
  • Validation that:
    a. Cooking and preparation instructions on the product are sufficient to destroy pathogens.
    b. Instructions are realistic for the intended consumer.
A product containing a meat/poultry component that has received a lethality treatment for pathogens in combination with non-meat/poultry components that need to receive a lethality treatment by the intended user.

This includes meals, dinners, frozen entrees.

  

NRTE
  • Heat Treated but not Fully Cooked Not Shelf Stable - ISP 03H
 Product must be labeled with statements such as keep refrigerated or frozen. Use of SHI labeling is recommended.
  • Validation that:
    a. The meat/poultry component received an adequate lethality treatment for pathogens.
    b. Cooking and preparation instructions on the product are sufficient to destroy pathogens.
    c. Instructions are realistic for the intended consumer.
  • Features on labeling are conspicuous so that intended user is fully aware that product must be cooked for safety. This is best conveyed through the product name (e.g., "Cook and Serve") but may also be conveyed by the use of an asterisk on the product name that is associated with a statement on the principle display panel, or by a burst stating such things as "needs to be fully cooked," "see cooking instructions," or "cook before eating."
  • If necessary, hazard analysis should address whether instructions on the label are needed related to cross-contamination (e.g., avoid contact of contents) and prevention of pathogenic growth (e.g., promptly refrigerate leftovers).
A product containing a meat/poultry component that has received a lethality treatment for pathogens that may or may not be in combination with a non-meat/ poultry component that does not need to receive a lethality treatment by the intended user.

 

  

RTE
  • Not Heat Treated Shelf Stable – ISP 03E
  • Heat Treated Shelf Stable – ISP 03F
  • Fully Cooked Not Shelf Stable – ISP 03G
  • Products with secondary inhibitors Not Shelf Stable – ISP 03I
 If the product is not shelf stable labeling such as keep refrigerated or frozen is required.
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