1. Microbial Risk
4/26/2017

2. Food Safety and Inspection Service
Microbial Risk
Food Safety and Inspection Service
A Risk-based Approach to Preventing Listeriosis in the U.S.
4/26/2017
The FSIS Approach to Listeria monocytogenes Control
Daniel L. Engeljohn, PhD
Assistant Administrator
Office of Policy and Program Development
Food Safety and Inspection Service
U.S. Department of Agriculture

3. Food Safety and Inspection Service
Mission in Action
FSIS is the public health agency in the USDA responsible for ensuring that meat, poultry, and processed egg products are safe, wholesome, and accurately labeled.
Federal Meat Inspection Act (FMIA), 1906
Agricultural Marketing Act (AMA), 1946 (select sections)
Poultry Products Inspection Act (PPIA), 1957
Humane Methods of Slaughter Act (HMSA), 1958
Egg Products Inspection Act (EPIA), 1970

4. More than 9,600 employees strong
Food Safety and Inspection Service:
One Team, One Purpose
We work
together
protecting
to accomplish
our mission of
public health.
committed
More than 9,600 employees strong
skilled
motivated
highly
trained
diverse

5. Food Safety and Inspection Service
Food Safety Strategy for Listeria monocytogenes (Lm)
Since the first outbreak associated with a ready-to-eat (RTE) meat or poultry product in the U.S. in 1989, recurring outbreaks seemed to occur on a two-year cycle thereafter
FSIS began sampling for Lm in 1989 and established a standard of non-detectable (i.e., “zero tolerance”) in RTE product
In 2001, to further support implementation of HACCP, FSIS published a proposed rule to establish pathogen reduction performance standards for a variety of RTE foods
One of the standards was for post-lethality exposed RTE meat and poultry due to cross-contamination concerns
FSIS maintained the non-detectable standard for Lm for all product because of the need to minimize the presence of this controllable food safety hazard in the processing environment, the high case mortality rate, the susceptible population
In 2003, FSIS issued an interim final rule on Lm essentially unchanged
FSIS verification testing was instrumental in spurring industry to take steps to know where Lm or Listeria species was present in the operation

6. Food Safety and Inspection Service
FSIS Lm Risk Assessments
Systematic, sequential use of science and risk assessments to guide policies and inspection to prevent listeriosis:
Which RTE foods pose the greatest risk of listeriosis?
2001/2003 FDA-FSIS risk-ranking
Which processing controls most effectively reduce the risk of listeriosis? How effective are they?
2003 FSIS Deli Meat Risk Assessment
How can USDA-FSIS inspection resources be effectively utilized across manufacturers?
2005 FSIS Risk-based Lm Verification Sampling
What others areas along the supply chain should efforts be focused?
2010 FSIS Comparative Lm Risk Assessment for Deli Meats (Endrikat et al., 2010)
How much do various retail practices and conditions contribute to the risk of listeriosis?
2013 Interagency Retail Lm Risk Assessment (Pouillot et al., 2015)

7. Food Safety and Inspection Service 2003 Interim Final Rule Design
Establishments producing post-lethality exposed RTE product must comply with requirements included in one of the following alternatives (9 CFR 430.4)
Alternative 1: Use post-lethality treatment AND an antimicrobial agent or process
Alternative 2: (a) Use post-lethality treatment OR (b) an antimicrobial agent or process
Alternative 3: Use sanitation measures ONLY

8. Food Safety and Inspection Service
Implementation of FSIS’s Risk-Based Lm Testing Program
FSIS verification testing allocated among establishments based on public health risk
Approximately10,000 product samples annually
Expanded to collect environmental and food contact sample (April 2006)
Risk defined quantitatively for each facility
Interim Final Rule enhanced FSIS oversight of RTE establishments, while providing incentives for industry to implement new preventive measures
Monthly ranking
Test and hold tested product “lot”
Equivalence determinations for Lm in RTE product consistent with the FSIS domestic approach and CODEX
Highest risk
Lowest risk
Alternative 3
Alternative 2 (a/b)
Alternative 1
Special focus on FSIS compliance guidance for processors (especially small/very small establishments)

9. Food Safety and Inspection Service
Microbial Risk
4/26/2017
Food Safety and Inspection Service
Changes to the FSIS Lm Verification Testing Programs
2013
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 125g test sample
RTEPROD_RAND–August 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–August Risk-based sampling of post-lethality exposed RTE products for Lm and Salmonella based on established product types and processing practices
2009
RLMENVC–Routine risk-based sampling of non-food contact environmental surfaces (RLMENVC) for Lm in RTE production areas
FSIS transitioned from collecting three non-composited environmental samples to collecting five samples that were composited into one sampling unit (see definition in RLMENVC)
2006
FSIS implemented the RLm sampling program and discontinued the RTERISK1 project and RTE001continued in its place; RLm involves a food safety assessment of the design and execution of the food safety system supplemented with testing of the product, food contact surfaces, and environment; scheduled in response to an FSIS positive finding for Lm, outbreak, or random

10. Food Safety and Inspection Service
Impact of FSIS Regulation and Industry Response
Significant Reduction of Lm in RTE Meat & Poultry Products
*FSIS results of routine regulatory testing of finished RTE meat and poultry products analyzed for Lm ( ). Approximately 4,000-10,000 samples taken annually.

11. Food Safety and Inspection Service Success with Risk-based Policies
Hot Dogs
Deli Meats
Year
Cases
Deaths
1998
112 14
1999 4 7 2
2000 30
2001 28
2002 54 8
2003
2004
2005 13 1
2006
2007
2008
2009
2010
2011
*Adapted from Cartwright et al. 2013

12. Food Safety and Inspection Service
Microbial Risk
Food Safety and Inspection Service
Success with Lm Attribution Changes
4/26/2017
FSIS CDC Foodborne Disease Outbreak Surveillance System (FDOSS) and the simple food attribution methodology to estimate how many foodborne Lm illnesses are associated with FSIS-regulated products
FSIS uses a three year rolling window of FDOSS data to estimate attribution
From , 48.7% of Lm outbreaks were attributed to FSIS-regulated products using the simple food methodology.
Since 2008, FSIS’s simple food Lm attribution estimate has been 0% (aside from 1 Lm outbreak reported in pork products with 9 reported illnesses in 2011, causing FSIS attribution to increase from 0% in to 3.7% in )

13. Food Safety and Inspection Service
Microbial Risk
Food Safety and Inspection Service
Percent Positive by Product Type
4/26/2017
Looking at historical sampling data to approximate relative risk:
HACCP Processing Categories
Finished Product Categories1
Production Volume Categories (by Product Groups)
Risk Level
% Positive
Rank % Positive
Fully Cooked-Not Shelf Stable
RTE fully-cooked meat / RTE fully-cooked poultry
Other Fully Cooked Sliced Product 1
0.37 4
Hot Dog Products 2
Salad/Spread/Pate 3
0.42
Diced/Shredded
0.66
Meat + Nonmeat Components 5
Sausage Products 6
0.18 10
Patties/Nuggets 7
0.21 9
Other Fully Cooked Not Sliced Product 8
0.28
Not Heat Treated-Shelf Stable/Heat Treated-Shelf Stable
RTE acidified/fermented meat (without cooking)- / RTE acidified/fermented poultry (without cooking)
RTE fermented meat (sliced or not sliced)/ RTE fermented poultry (sliced or not sliced)
(Acidified/Fermented Products)2
0.46
RTE dried meat / RTE dried poultry
RTE dried meat (sliced or not sliced)/RTE dried poultry (sliced or not sliced)
(Dried Products) 2
0.14 11
RTE salt-cured meat / RTE salt cured poultry
RTE salt-cured meat (sliced or not sliced)/ RTE salt-cured poultry (sliced or not sliced)
(Salt-cured Products) 2
0.24
Product with Secondary Inhibitors – Not Shelf Stable 12

14. Food Safety and Inspection Service
Microbial Risk
Food Safety and Inspection Service
Risk-based and Random Verification Testing Programs
4/26/2017
In August 2013 FSIS initiated the RTEPROD_RISK and RTEPROD_RAND projects
Under the RTEPROD_RAND project samples are collected at random from entire frame of establishments, and under the RTEPROD_RISK project, samples are selected from the riskiest establishments
Data analysis shows that the results of the risk-based project had a lower percent positive than the random project, indicating the risk factors may have changed over time
2013
Positive
Negative
Total
Rate
RTEPROD_RAND 6
1,344
1,350
0.44%
RTEPROD_RISK 9
3,329
3,338
0.27%

15. Food Safety and Inspection Service
Microbial Risk
Food Safety and Inspection Service
Lm Quantification
4/26/2017
FSIS started quantifying Lm in early 2006
For 2006 and 2007, the lowest Most Probable Number (MPN) level was <0.3 MPN/gram
In early 2008, the limit of detection (LOD) for MPN was lowered 10-fold (0.03 MPN/gram)
There is an obvious shift of MPN/g levels over time from samples in the higher ranges to the lower ranges

16. Number of Lm-positive Samples in MPN/g ranges (LOD = 0.03/gram)
Microbial Risk
Food Safety and Inspection Service
Lm Quantification
4/26/2017
Number of Lm-positive Samples in MPN/g ranges (LOD = 0.03/gram)

17. Percent of Lm-positive Samples in MPN/g ranges (LOD = 0.03/gram)
Microbial Risk
Food Safety and Inspection Service
Lm Quantification
4/26/2017
Percent of Lm-positive Samples in MPN/g ranges (LOD = 0.03/gram)

18. Food Safety and Inspection Service
Use of Pulsed Field Gel Electrophoresis (PFGE)
Letters will be issued to establishments each time there is a positive result. The letters will provide:
A list of all isolates within the last 5 years
PFGE pattern name, and
Harborage or cross contamination
The letters will describe corrective actions that RTE producers should take in response to the information in the letters. Possible corrective actions may include:
Reassessing the HACCP plan or reevaluating the SSOP
Performing a comprehensive investigation
Taking preventative measures to prevent harborage and cross contamination

19. PFGE Pattern Type Within Establishment
Food Safety and Inspection Service
Cross Contamination and Harborage of Lm Over Time
Incidence of Multiple Isolations of the Same PFGE Subtype within the Same Establishment, Sampling Cycle Note: Establishment is a numerical ranking, not an identifier.
Establishment
PFGE Pattern Type Within Establishment
RLMPROD/ RLMPRODC
RLMCONT
RLMENVC
Total 1 3 8 9 2 6 7 5 4 15 16 13 18 10
Cross contamination is indicated when the same pattern is found in different sample types in the same establishment over one day.
Harborage is indicated when the same pattern type is found in the same establishment over time
A comparison of PFGE pattern types revealed 24 (8.3%) establishments with cross-contamination and 37(12.8%) establishments with harborage out of  289 establishments with positive samples

20. Food Safety and Inspection Service
Microbial Risk
Food Safety and Inspection Service
Affirmation of the Interim Final Lm Rule
4/26/2017
On June 19, 2015, FSIS announced in a Federal Register Notice (80 FR 35178; Jun. 19, 2015) that it is affirming the 2003 rule. As part of this affirmation FSIS is:
Making minor changes to the regulatory provisions in response to comments that the Agency received.
Clarifying in the regulations that establishments may not release into commerce product that has been in contact with Lm-contaminated surfaces without reprocessing the product
Removing the requirement for establishments to report production volume and related information to FSIS because the Agency now routinely collects this information through its Public Health Information System (PHIS)

21. Food Safety and Inspection Service:
FSIS Commitment to Real-Time Lm WGS – an Interagency Project
FSIS is participating in the multi-Agency collaboration to provide Lm WGS data in real-time
Support of epidemiologic investigations
As part of this collaboration
FSIS is sequencing all isolates (food and environmental swabs)
August March 2015: 249 isolates sent to FDA-CFSAN
April 2015 – Present: sequenced and directly uploaded Lm isolate data into NCBI
NCBI Accession Number to CDC PulseNet to link the PFGE and WGS sequence data

22. Food Safety and Inspection Service Lm at Retail
Retail Lm Compliance Guide: In June 2015 FSIS issued the Best Practices Guidance for Controlling Lm in Retail Delicatessens. This guidance document advises retailers of specific actions they can take to decrease the potential for Lm growth or cross-contamination in the deli area
Next Steps: Surveillance at Retail: Beginning in 2016, FSIS will be conducting focused in-commerce surveillance of RTE meat and poultry products at retail delis, and documenting adherence to best practices to reduce Lm at retail. FSIS plans to work closely with federal partners and the states

23. Food Safety and Inspection Service
Timeline of Key Events Related to Lm: Science-Based Prevention
Emerging Issue
Paradigm: Vulnerable Populations/Growth Lm/High Levels
Changing Risk?
2000’s – Lm outbreaks: Variety of RTE Foods that support Lm growth
Outbreaks primarily associated with soft and Mexican-style cheeses and RTE meat and poultry products
2002: Large listeriosis outbreak among elderly associated with turkey deli meats in Northeastern U.S. (46 culture-confirmed cases, 7 deaths)
2010’s – Lm outbreaks: “low risk” foods; healthy children; “low dose”
2011: Largest outbreak in U.S. history from cantaloupes (147 cases; 33 deaths)
2014: Outbreak - caramel apples; healthy children (35 cases; 7 deaths)
2015: Outbreak - ice cream; low Lm levels (10 cases, 4 deaths)
1990’s – Lm outbreaks --variety of RTE foods that support Lm growth
: 3nd largest listeriosis outbreak in U.S. history – linked to frankfurters (108 cases, 14 deaths)
incidence: 4.8 cases per 100,000 population
1980’s – Lm a recognized foodborne pathogen
1983: Pasteurized milk outbreak (449 cases; 14 deaths)
1985 Mexican style soft cheese outbreak (142 cases, 52 deaths)
1989: Listerial meningitis linked to turkey frankfurters
2000’s – Risk-based Policies and Programs (targeted efforts at processing)
2001: Draft FDA- FSIS risk-ranking for RTE foods (highest risk: deli meats)
2003: FSIS risk assessment evaluates effectiveness of process controls and sanitation (leads to FSIS Listeria Rule)
2004: FSIS develops risk-based inspection program/targets inspection/motivate industry adoption of controls (SUCCESS)
1980’s – Surveillance & Focus on Prevention
1986: CDC begins active listeriosis surveillance at sentinel locations
1989: U.S. intensified Lm monitoring and verification sampling of RTE products; “zero tolerance” adopted
1990’s – Strengthen Surveillance (FoodNet) & Inspection (HACCP)
1996: Active listeriosis surveillance incorporated into FoodNet
1996: USDA-FSIS modernizes its inspection program (1996 HACCP Rule)
1998: FDA & USDA-FSIS initiated 1st Listeria risk assessment to identify which RTE foods pose the greatest risk (FDA-FSIS risk ranking)
75% decline of Lm in FSIS-tested RTE meat and poultry products
42% decline in the incidence of listeriosis in the U.S.
2010’s – Focus on Retail; Modernize Subtyping; Acknowledge Knowledge Gaps
2010: FSIS Comparative Lm risk assessment -focus on retail risk (83% of deli meat listeriosis cases)
2013: Interagency Retail Lm Risk Assessment: cross-contamination/no growth foods a risk
Whole genome sequencing used to identify outbreaks more quickly; new food vehicles

24. Food Safety and Inspection Service:
Questions?