Microbiological Testing Program for RTE Meat and Poultry and Pasteurized Egg Products

The Food Safety and Inspection Service (FSIS) has conducted a regulatory microbiological testing program for Ready-to-Eat (RTE) meat and poultry products since 1983. RTE products are fully cooked before packaging and do not require further cooking by the consumer. However, these products are susceptible to contamination with pathogens during peeling, slicing, repackaging, and other processing steps after the required kill step to eliminate pathogens. Listeria monocytogenes (Lm) is a pathogen of particular concern for RTE products, because it is capable of growth at refrigerated temperatures. Processing establishments ensure RTE products do not become contaminated with Lm or other pathogens of concern, such as Salmonella, by applying a treatment to the product after its exposure to the processing environment (post-lethality treatment), and use a growth inhibitor (antimicrobial agent or process) to prevent the growth of L. monocytogenes in the product up to its declared shelf life.

The Egg Products Inspection Act (EPIA) was passed in 1970 to provide mandatory inspection of the processing of liquid, frozen, and dried egg products. The EPIA and the associated regulations (7 CFR Part 59) laid out the requirements to assure that eggs and egg products are wholesome and not adulterated, as well as properly labeled and packaged. The Agricultural Marketing Service's (AMS) Poultry Division administered mandatory inspection of egg products under the EPIA. On May 28, 1995, AMS transferred the responsibility for regulating pasteurized liquid, frozen, or dried egg products to the Food Safety and Inspection Service (FSIS).

RTE Meat & Poultry

Currently, FSIS samples RTE products through three sampling programs: RTEPROD_RAND, RTEPROD_RISK, and RLm.

FSIS conducts routine sampling of RTE products under RTEPROD_RAND and RTEPROD_RISK.

RTEPROD_RAND samples are taken randomly at establishments producing RTE products. FSIS maintains separate programs for each pathogen.
- RTEPROD_RAND Lm
- RTEPROD_RAND Salmonella
RTEPROD_RISK samples are taken for post-lethality-exposed product, based on risk. FSIS maintains separate programs for each pathogen.
- RTEPROD_RISK Lm
- RTEPROD_RISK Salmonella

Listeria monocytogenes (Lm) can grow and persist in the food-processing processing environment. FSIS inspectors collect food samples, samples from food contact surfaces, and from non-food contact environmental surfaces in the post-lethality production areas of RTE meat and poultry processing establishments. This approach ensures establishments control Lm contamination in post-lethality exposed RTE products as detailed in regulation 9 CFR 430.

The routine risk-based Lm (RLm) sampling program was designed to detect Lm in the environment of a production establishment.

RLMPRODC are routine product samples taken for post-lethality-exposed product, based on risk.
RLMCONT are routine food contact surface swab samples taken for post-lethality-exposed product, based on risk.
RLMENVR are routine samples of brine or chill water that does not come into direct contact with post-lethality-exposed product.
- When no RLMENVR samples test positive for Lm, no tables are shown.
RLMENVC are routine non-food contact environmental surface swabs samples exposed to the post-lethality environment, based on risk.

2019

On January 2, 2019, FSIS laboratories began using the 3M™ Molecular Detection System for initial screening of regulatory samples for Salmonella and Listeria monocytogenes (Lm), following the completion of an evaluation of commercially available rapid pathogen screening technologies. Further, on March 15, 2019 FSIS suspended the routine use of PFGE for the characterization of Salmonella; whole genome sequencing (WGS) is being used as the primary tool for characterization of Salmonella isolates. The decision to characterize these isolates via WGS was taken in coordination with federal and public health partners at the Centers for Disease Control and Prevention (CDC) PulseNet network.

2018

In coordination with CDC PulseNet, FSIS suspended PFGE for Lm and as of January 15, 2018, started generating Lm characterization through WGS only.

2016

On October 1, 2016, FSIS made a change to the algorithm used for scheduling RTEPROD_RISK and RTEPROD_RAND samples and also changed the allocation of samples to each of the programs that is further described in Random and Risk-based Scheduling Criteria for the RTE Product Routine Sampling Program. This was done for two reasons: 1) To properly target product groups based on historical sampling data, and 2) To use the alternative identified by the establishment to control Lm in the sampling methodology.

2013

RTEPROD_RAND-Random sampling of Lm and Salmonella in RTE products for both post-lethality exposed and non-post-lethality exposed products (e.g., cook-in bag products).

RTEPROD_RISK-Risk-based sampling of post-lethality exposed RTE products for Lm and Salmonella based on established product types and processing practices.

Under RTEPROD, FSIS collects 2 pounds of product. FSIS labs analyze a 25g sample for Lm and another 325g sample for Salmonella. If any positive isolates are confirmed, FSIS labs then enumerate using MPN on the sample reserve and perform PFGE on the positive isolates. In August 2013, FSIS replaced the ALLRTE and RTE001 sampling projects with RTEPROD_RAND and RTEPROD_RISK respectively.

RLMPRODC-Routine risk-based sampling project designed to obtain intact RTE food product samples for Lm collected from a production line that is in operation at the establishment.

In January 2013, FSIS replaced the RLMPROD sampling project with RLMPRODC. Under RLMPRODC, FSIS collects five 1 pound samples within a sample unit. FSIS labs remove five 25g sub-samples from each unit, which are composited at the testing laboratory into a single test sample. FSIS increased the number of samples from 3 to 5 when the RLMPRODC sampling project was implemented.

2009

RLMENVC-Routine risk-based sampling of non-food contact environmental surfaces (RLMENVC) for Lm in RTE production areas having indirect (e.g. mop handles or outer garments that may be handled by a person who may touch RTE product) or no contact (e.g., floors, drains, walls, air vents, overhead structures) with the sample product lot. The five environmental swab samples are composited at the testing laboratory into a single test sample rather than analyzing each individually.

FSIS transitioned from collecting three non-composited environmental samples to collecting five samples that were composited into one sampling unit (see definition in RLMENVC).
FSIS changed the number of swab samples collected to increase the number of establishments scheduled each month from 15 to 45.

2006

FSIS implemented RLm, phase 2 of the Lm risk-based sampling program. RLm included sampling of products, product contact surfaces, and environmental surfaces in conjunction with a comprehensive Food Safety Assessment (FSA). FSIS Directive 10,240.5 provided 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.

In calendar year 2006, FSIS discontinued the RTERISK1 project and RTE001 continued in its place.

RLMPROD-Routine risk-based sampling project designed to obtain intact RTE food product samples for Lm collected from a production line that is in operation at the establishment.

RLMCONT-Lm routine risk-based sampling project designed to obtain food contact surface samples in the RTE production areas that have direct contact (e.g., conveyor belts, cooler storage racks, luggers, slicers, peelers, loaders, table tops).

Brine or chill water samples are considered to be contact surface samples, if they come in direct contact with exposed product, or the product is in a semi-impermeable casing.

RLMENVR-Routine risk-based sampling project designed to obtain for Lm selected from brine or chill water that does not come into direct contact with post-lethality exposed RTE product.

Brine or chill water is considered to be environmental samples if the product is in an impermeable casing or otherwise packaged.

2005

RTE001-Lm and Salmonella sampling project used primarily to verify that establishments producing post-lethality exposed meat and poultry products are controlling the pathogens and are in compliance with the zero tolerance requirements of 9 CFR 430 for Lm.

2004

ALLRTE-Lm and Salmonella sampling project designed to obtain random samples across all RTE products and throughout establishments producing a RTE product, regardless of the risk or product type.

RTERISK1- Product selection was based on the risk-based guidance provided in FSIS Directive 10,240.4 in October 2003. However, once a RTERISK1 sample was scheduled, inspection program personnel were instructed to collect only Alternative 3 products if they were available. (Definitions for RTE Alternatives 1, 2, and 3 can be found in 9 CFR 430.4.)

2003

FSIS began target sampling of RTE products. Under FSIS Directive 10,240.3, inspection program personnel received a form requesting a sample under the target project. The form included instructions to collect a RTE sample based on priority: high (e.g., deli meats) and medium (e.g., franks/hot dogs). During this process, inspection program personnel designated whether the product was a targeted product or low-targeted product.

2001-2002

FSIS discontinued its RTE testing program on selected product categories and began sampling based on Hazard Analysis and Critical Control Point (HACCP) processing categories identified in 9 CFR 417.2 that apply to RTE products. This transition is detailed in FSIS Directive 10,240.2, Microbial Sampling of Ready-to-Eat (RTE) Products.

Highlights of how the 2017 results differ from 2016’s, in the RTE Sampling Programs

Routine Salmonella sampling of RTE products under RTEPROD_RAND and RTEPROD_RISK.
- In 2017, positive samples showed a major decrease - overall, one sample-tested positive out of 14,645 (0.01% positive) compared to 2016, where 14 samples tested positive out of 13,977 (0.10% positive).
Routine Listeria monocytogenes sampling of RTE products under RTEPROD_RAND and RTEPROD_RISK.
- In 2017, positive samples were similar - 30 samples tested positive out of 14,646 (0.20% positive) compared to 2016, where 27 samples tested positive out of 13,983 (0.19% positive).
Routine risk-based sampling project designed to obtain intact RTE food product samples for Lm (RLMPRODC)
- In 2017, positive samples decreased - zero positive samples were identified from 468 (0.0% positive) compared to 2016, where two positive samples from 515 were identified (0.39% positive).
Routine risk-based sampling project designed to obtain food contact surface samples for Lm (RLMCONT)
- In 2017, positive samples increased - eight positive samples were identified from 4,614 (0.17% positive) compared to 2016, where seven positive samples from 5,133 were identified (0.14% positive).
Routine risk-based sampling project designed to obtain non-food contact and environmental surfaces for Lm (RLMENVC)
- In 2017, positive samples increased - 41 positive samples were identified from 465 (8.82% positive) compared to 2016, where 33 positive samples from 514 were identified (6.42% positive).

Tables and Results

View Tables & Results from 2017 to 2015

Pasteurized Egg Products

Responsibilities assumed by FSIS include:

performance of mandatory inspection of egg products,
oversight of the residue monitoring program for egg products,
supervision of a Salmonella surveillance recognized laboratory program,
oversight of the microbiological monitoring program, and
review and approval of egg products labels.

Change on September 21, 2016

To enhance public health protection associated with pasteurized egg products for consumers, FSIS modernized its egg products sampling programs to mirror FSIS’ other ready-to-eat (RTE) testing programs. Therefore, all domestic and imported pasteurized egg products that FSIS analyzes for Salmonella will be co-analyzed for Listeria monocytogenes (Lm) starting on September 21, 2016. On September 21, 2016, FSIS eliminated the domestic egg products (EGGDOM) sampling program in which FSIS conducted the analysis for Lm quarterly and at the end of shelf-life on products with shelf-life claims. Instead, the Agency will continue to collect samples of dried, frozen, and liquid pasteurized egg products under its seven egg monitoring (EM) and imported egg products (EGGIMP) sampling projects and test them for both Salmonella and Lm.

There are seven egg product categories-four liquid and three dried. Each egg product category has a different time and temperature pasteurization process requirement based upon the composition of the egg product. Each month, inspectors collect one egg sample per process from each plant that produces egg products. FSIS Field Service Laboratories analyze the samples for the presence of Salmonella. Thus, inspectors could sample an egg product production plant as many as seven times per month depending on the number of plant production processes occurring during the month.

**Summary of Salmonella percent positives in pasteurized egg products**

1995	FSIS began testing pasteurized egg products for Salmonella. The Salmonella percent positive was 1.63%.
1996	During the second year of the testing program, the Salmonella percent positive was 0.62%. Comparing the results of the first two years, there is a considerable decrease (1.01, or 62%) in Salmonella percent positives.
1997 to 2007	During this ten-year period, there were moderate fluctuations in the Salmonella percent positives. FSIS detected the highest percent positive in 1999 at 0.82% and the lowest percent positive in 2007 at 0.07%.
2008 to 2017	Beginning January 2008, FSIS began reporting microbiological results by collection date as opposed to analysis end date to align FSIS activities with those of their federal partners and to standardize reporting of yearly and quarterly results from the various microbiological verification programs. The results from 2008 onward cannot be compared with results from previous years because of the change in reporting, therefore, for ease of viewing and comparison, the tables and figures have been separated based on specific calendar year time ranges. The Salmonella percent positive from 2008 to 2017 was 0.14%.