Scenario 18-02 :  Microbial Sampling of RTE Products for FSIS Verification Testing Programs-Background Information: December 3, 2002

On December 9, 2002, FSIS Directive 10,240.3, Microbial Sampling of Ready-To-Eat (RTE) Products for the FSIS Verification Testing Program will be signed and effective. This issuance will cancel FSIS Directive 10,240.2 and outlines new verification steps that FSIS will take in establishments to ensure control of pathogens or toxins of public health concern: Listeria monocytogenes, Escherichia coli 0157:H7, Salmonella, and Staphylococcal enterotoxin.


The following series of scenarios are informational exercises meant to facilitate FSIS program personnel’s understanding in advance of this upcoming new issuance which will be issued on December 9, 2002:

This information is intended to familiarize program personnel with new procedures outlined in the issuance. Please be aware that this informational material is in no way intended to address all questions related to the implementation of this new issuance and the procedures outlined therein. If you have any questions, please contact your Frontline Supervisor or the Technical Services Center at or 800-233-3935.


FSIS is changing the way it directs its resources regarding the sampling of RTE products. FSIS is moving towards a risk-based sampling program in which products posing the highest risk for contributing to human illness will be selectively scrutinized by FSIS.

Under this issuance, plants producing high, medium, and low risk ready-to-eat (RTE) products that do not have a science-based product, food contact surface, and environmental testing regime designed to find and take necessary actions to eliminate Listeria monocytogenes, will be placed under an intensified testing program by USDA’s Food Safety and Inspection Service (FSIS). This intensified testing program will consist of increased testing of the final product, and testing of food contact surfaces and plant environment. Plants that have such a science-based testing program but do not choose to share their testing data with FSIS on an ongoing basis will also fall under the intensified testing program. Within the new issuance, new tools are added for FSIS to use in the review of records and in sampling.

FSIS will be focusing on two aspects of the production process for these products: The review of records associated with the preventative food safety systems (i.e., the HACCP Plan, Sanitation SOP, or prerequisite program), and the sampling of product for pathogens and toxins of public health concern.

The records review will include looking at all testing data associated with the production of product, as well as the scientific basis for the design of the preventative system and the on-going verification program.
Regarding testing, FSIS will focus on products that have a greater likelihood of becoming contaminated after the lethality step.

FSIS is identifying that certain RTE products present a greater risk to public health than do others. To address this, FSIS is distinguishing these riskier products as those that are exposed to the environment after the lethality step (e.g., a cook-in-the-bag product that is removed from the bag and then sliced). The deli-type products often are pre-sliced in the Federal establishment or are sliced at the deli-counter. Many of these products, however, are formulated or treated to inhibit growth of Listeria monocytogenes and may present a different risk profile.

FSIS will test these riskier products at different frequencies, depending upon whether the establishment provides all records and laboratory results to FSIS for its review.
For those high risk RTE products that support growth of Listeria monocytogenes and for which the data is not available to FSIS, FSIS will test product, food contact surfaces, and the environment at an intensified frequency.
Trained FSIS personnel will collect the food contact and environmental samples.
FSIS will collect numerous samples representing an individual production lot.
This increased sampling will enhance the value of individual samples results above the value in the current testing program.
Negative results will provide FSIS greater confidence that the production process was properly controlled by the establishment.

In this new risk-based testing program, the Agency will consider three major criteria in determining testing priorities:

  1. The product’s risk:
High-risk products are deli-type products, such as products that are sliced in the establishment or are likely to be sliced in a deli.
Medium-risk products are hot dog-type products, such as wieners or frankfurters.
Low-risk products are those that are stable with respect to growth of Lm due to pH, water activity, antimicrobial agents, freezing, or validated post-lethality treated products.
  1. The operation’s risk (high, medium, or low)
  2. The establishment’s method of control of pathogens of public concern and the availability of their records.


New Definitions and Terminology:

Environmental Samples – Samples from surfaces that have:

indirect or potential contact with exposed RTE product in the RTE production area (e.g., mop handles, outer garments, etc., that may be handled by a person who may touch RTE product), or
no contact with RTE product in a RTE production area (e.g., floors, drains, walls, overhead structures).

Food Contact Surface – For purposes of this issuance, a surface of equipment or a utensil with which exposed RTE product has direct contact (e.g., conveyor belt, tabletop, knife blade). A food contact surface does not include aprons, mop handles, gloves, and other items that may have indirect or potential contact with exposed RTE product.

Food Contact Surface Samples – A collection of samples (e.g., swabs) from food contact surfaces that represent the conditions under which the sampled lot was processed. The samples are collected during the production shift, not pre-operational, but without disrupting production, such as during breaks and at the end of a shift.


High or Medium Risk Operation – For purposes of this issuance,

    1. All establishments defined as large in the July 26, 1996 Pathogen Reduction/Hazard Analysis and Critical Control Point Systems (PR/HACCP) final rule that produce any amount of high or medium risk product;
    2. Any establishment defined as a small or very small establishment in the July 26, 1996 final rule that:
  1. Produces a large volume of high or medium risk products;
  2. Produces any volume of high or medium risk products and has a history of multiple or recurring sanitation (procedures 01B, 01C, 06D) noncompliance records (NRs) in the in the area of the facility where RTE product is exposed to the environment; or
  3. Produces any volume of high or medium risk products and is operating under conditions that have historically been associated with findings of L. monocytogenes on product or in the environment (e.g., construction activity that may affect the presence of Listeria), but does not have a science-based control program to address this situation.

High or Medium Risk Products – For purposes of this directive, these meat and poultry products are

  1. deli-type products (high risk), that include, but are not limited to the following products that either are sliced in the establishment or likely will be sliced at retail (e.g., at a deli counter): cured ham, cooked ham or turkey, bologna, luncheon meat, pastrami, and other cold cuts;
  2. hot dog-type products (medium risk) that include any meat or poultry type wieners or frankfurters; and
  3. products that have not been formulated or are not produced and distributed under conditions validated to prevent the growth of L. monocytogenes.

Low Risk Operation – For purposes of this issuance, any establishment that produces low risk product and:

    1. Doesn’t have a history of multiple or recurring sanitation (procedures 01B, 01C, 06D) noncompliance records (NRs) in the in the area of the facility where RTE product is exposed to the environment; or
    2. Has a science-based control program to address conditions that have historically been associated with findings of L. monocytogenes on product or in the environment (e.g., construction activity that may affect the presence of Listeria).

Low Risk Products – For purposes of this issuance, these meat and poultry products are deli-type products (i.e., products that either are sliced in the establishment or will be sliced at retail) and hot dog type-products that have been formulated or are produced and distributed under conditions validated to prevent the growth of L. monocytogenes. These products are stable with respect to growth of L. monocytogenes by any of the following means:

pH < 4.5
pH < 5.0 + refrigerated storage
aw <0.90
aw <0.92 + refrigerated storage
aw <0.95 + pH <5.5
the presence of an antimicrobial agent (e.g., sodium or potassium lactate, sodium diacetate) that has been validated through scientific studies to inhibit growth of L. monocytogenes
Product that is held at or below 0° C (32° F) and is labeled "Keep Frozen" and does not meet the criteria for Not-RTE (see Attachment 2), or
Product that has received a post-lethality treatment that has been validated to be lethal for L. monocytogenes.

Non-targeted verification testing program – Operations that exclusively produce the types of products listed below fall into this category:

  1. Lard,
  2. Margarine,
  3. Lard margarine,
  4. Mixtures of rendered animal fats,
  5. Popped pork skins,
  6. Pork rinds,
  7. Dried soup base samples,
  8. Concentrated (high salt content) soup mixes,
  9. Pickled pig’s feet, or
  10. Product labeled "For Further Processing" in which the product is expected to receive a lethality treatment

Pathogen or Toxin of Public Health Concern – Any microorganism or other biological agent that has the ability to cause disease in humans. For purposes of this issuance, these pathogens and toxins include E. coli O157:H7, L. monocytogenes, Salmonella, and staphylococcal enterotoxin.

Prerequisite Program - For purposes of this issuance, prerequisite programs are procedures other than Sanitation SOPs that are designed to provide the basic environmental and operating conditions necessary for the production of safe, wholesome food and to control L. monocytogenes. Because of its prerequisite program, an establishment may decide that a food safety hazard (e.g. L. monocytogenes) is not reasonably likely to occur in its operation. The establishment would need to document this determination in its Hazard Analysis and include the procedures (e.g., regular auditing and documentation) it employs to ensure that the program is working and that the hazard is not likely to occur (9 CFR 417.5(a)(1)).

Ready-to-Eat (RTE) Product Product that is intended to be consumed without any

further safety preparation steps. FSIS will sample and test RTE products produced under the following processing categories:

  1. not heat treated—shelf stable (9 CFR 417.2(b)(v), ISP HACCP process 03E)
  2. heat treated—shelf stable (9 CFR 417.2(b)(vi), ISP HACCP process 03F)
  3. fully cooked—not shelf stable (9 CFR 417.2(b)(vii), ISP HACCP process 03G)
  4. product with secondary inhibitors—not shelf stable, (9 CFR 417.2(b)(ix), ISP HACCP process 03I).

RTE Product Samples – A collection of sampled RTE product that represents the sampled lot. The samples are taken from product that has passed the establishment's pre-shipment HACCP review. The sampled product should be in its consumer-ready package whenever possible. When this is not possible (e.g., only bulk product is being produced and the immediate container is too large to ship), inspection program personnel may permit the establishment to short-weight or slack-fill the immediate container. In such cases, the sample must be produced and packaged in the same way as the product that it represents; the only difference would be that the contents of the package would be less than the contents of the packages that it represents. Minimum sample sizes for analysis are defined in FSIS Directive 10,210.1 or are provided in block 18 of the sample request form, FSIS Form 10,230-3.

RTE Production Area - An RTE production area is one where exposed RTE products are stored, further processed, or packaged. This is the area from which food contact surface samples and environmental samples are taken and analyzed for indicator organisms or L. monocytogenes.

Sampled Lot - Based on the establishment’s definition of a lot, the sampled lot would be the amount of product represented by one or more product and food contact surface samples. As a guide, FSIS considers all product produced under a single HACCP plan between performance of complete cleaning and sanitizing procedures (clean-up to clean-up, including start to finish under extended clean-ups) to be an appropriate definition of a sampled lot. In situations where recall, retention, or seizure is necessary, FSIS may determine that more product or less product than that produced from clean-up to clean-up under the HACCP plan is represented by the sample. In making this determination, FSIS will consider such factors as the establishment’s history of practices for setting lot size and the definition of lot size as defined in the establishment’s sampling program; coding of product; the pathogen of concern; the processing and packaging; the equipment; the decision-making documents that the establishment is required to maintain under 9 CFR 417.5(a)(2); the establishment’s testing under its HACCP plan; the establishment’s HACCP plan monitoring and verification activities performed in accordance with 9 CFR 417.2 and 417.4; the establishment’s Sanitation SOP records as required in 9 CFR 416.16; and whether some or all of the products controlled by the same or substantially similar HACCP plans have been affected, including whether the establishment has documentation to support that potential contamination would be limited to individual production lines and for individual products.


Please see the attached Flowchart: Determining Testing Verification Program, for a visual representation of the decisions made in determining which testing program will be utilized in each establishment.

Flowchart: Determining Testing Verification Program

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