#### FDA/Center      for Food Safety and Applied NutritionCenters for Disease Control and PreventionNovember 2, 2005

## Current FDA Activities Related to the *Listeria**monocytogenes*Action Plan

##### Objective 1: Develop and revise guidance forprocessors that manufacture or prepare ready-to-eat foods and develop or reviseguidance for retail and food service and institutional establishments.

-  FDA will develop and issue guidance on enhancing the safety ofthe production of fresh-cut produce .    - A Produce Action Plan Public Meeting was held on 6/29/04.  One of the outcomes of the meeting was a greater need to involve the retail segmentof the food industry in training regulators/industry in ensuring the safety ofproduce. One of the organisms of concern mentioned was  Listeriamonocytogenes  (Lm).  *FDA, in cooperation with Michigan State University, will continueto examine the levels of Lm transferred in retail food establishments.Specifically, the project is to study transfer rates between foods contaminatedwith Lm and food contact surfaces (i.e., slicing machines, knives, spoons,etc.).*- This was a grant awarded through the Center for Food Safety andApplied Nutrition's (CFSAN) Office of Science collaborative grant process in2002. The researchers are writing a paper for peer review.  These resultsshould be considered as we move forward and discuss appropriate interventionstrategies at retail.
FDA will review the Model 
Food Code
 to determine ifprovisions that address preventive controls, such as approved source, datemarking, and cold-holding times and temperatures, warrant revision.
The 2002-2004 Conference for Food Protection (CFP) Date-markingCommittee compiled a list of 
Food Code
 sections that pertain to Lmcontrol.  The Committee is currently in the process of developing a guidancedocument detailing the use of targeted sanitation procedures to assist in thecontrol of Lm
.
FDA issued a Federal Register Notice on March 4, 2005 requesting the following data and information from the retail and foodserviceindustry:
Lm levels in products stored in retail and foodservicefacilities;
Levels of environmental harborage of Lm on food and non-foodcontact surfaces;
Effects of short and long-term refrigerated storage on levels of Lm;
Impact of time and temperature on levels of Lm in products
Efficacy of cleaning procedures and sanitizing agents onenvironmental surfaces and utensils;
Frequency of use and efficacy of adding inhibitors to foodproducts in retail and food service establishments to reduce or prevent Lmgrowth; and
Effect of training regarding hygienic practices and sanitation onlevels of Lm in products in retail and foodservice establishments.  

- FDA will issue guidance, in conjunction with the CFP, to theretail and food service industry and state and local regulatory professionalson the use of HACCP principles to identify and control risk factorscontributing to foodborne illness.  This guidance will include interventionstrategies that can be used to control  Lm  and other pathogens.    - At their 2004 meeting the CFP accepted two HACCP guidancedocuments developed by FDA and reviewed by the CFP HACCP Committee.  These twoguides outline the identification and control of risk factors by industryoperators and the use of risk-based inspections by regulators.  Many of theintervention strategies outlined in the guides pertain to the control of Lm.The guides have been widely disseminated to state and local regulatoryofficials and industry.  *FDA will promote the inclusion of Lm control strategies infuture guidance documents that address food processing at retail operations(e.g., smoked seafood, specialty meats).*- FDA representatives worked with the Association of Food and DrugOfficials (AFDO), the University of Florida, and Florida A&M University to developguidance for food processing at retail.  These guidance documents have beenfinalized and released.  The draft guidance documents were specificallyreviewed to assess the risk of Lm and the organism was identified as a hazardin a number of these guidance documents (e.g., Smoked Seafood, Cured and HotSmoked Sausage).
Lm guidance for dairy plants is under development at CFSAN.
FDA/CFSAN is developing guidance on the
 Control of 
Listeriamonocytogenes
 in Refrigerated Ready-To-Eat Foods.
Objective 2: Develop and deliver training andtechnical assistance for industry and food safety regulatory employees.-  Listeria monocytogenes  Preventative Controls forRegulators -satellite course under development.  Purpose:  To reviewexisting training for regulators and processors on preventive controls and guidanceand to update and develop training for regulators to reduce Lm related illnesses. Mode:  Satellite/web.  Satellite course  (3 hours in length)  Webcourse  (1 hour in length)  Primary Audience:  FDA andstate/local regulators of retail food, milk and manufactured food (includesseafood, except shellfish) operations. Secondary audience: industry. 
Objective 3: Enhance consumer and health care providerinfomation and education efforts. - Educational programs about the risks of listeriosis have takenplace through the media, health professional organizations, contacts withauthors of books on pregnancy, and educational programs for special at-riskgroups including seniors and pregnant women.  During the last 3 years, CFSANhas participated in a program of health fairs utilizing Hispanic radio andtelevision and Wal-Mart.   Health messages on the risk of listeriosis aredelivered over the Spanish language radio and television programs andinformation is distributed at health fairs at Wal-Mart locations in Hispanicareas.   A further specialized campaign targeted to the Latino community on theconcerns of queso fresco cheese was launched in the spring of 2005.  Theprogram utilizes the Hispanic media and community outreach workers (promotoras)to get the message out.   A public health educational campaign by thepublic-private Partnership for Food Safety Education is underway to adviseconsumers to keep their refrigerators at 40 degrees Fahrenheit to preventfoodborne illness, including listeriosis.  Information has been releasedthrough the media and is also being disseminated through grocery stores whererefrigerator thermometers are promoted.
Objective 4: Review, redirect, and revise enforcementand regulatory strategies including microbial product sampling and analyticalmethods. - The National Advisory Committee on Microbiological Criteria forFoods (NACMCF) adopted these two documents on August 27, 2004 - 1) Requisite Scientific Parameters for Establishing the Equivalence of Alternative Methods ofPasteurization and 2) Considerations for Establishing Safety-Based Consume-ByDate Labels for Refrigerated Ready-to-Eat Foods
- FDA's Bacteriological Analytical Manual (BAM) which presents the agency's preferred laboratory procedures for microbiological analyses of foods and cosmetics is updating manual to include quantitative method for Lm.
- On December 24, 2003, Hogan & Hartson L.L.P filed a Citizens' Petition  on behalf of a coalition of fifteen leading trade associations pursuant to  sections  402(a)(1)  and 701(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) and 21 C.F.R.  § 109.4. The Petition requested that FDA amend 21 C.F.R. Part 109 to establish  a regulatory limit for Listeria monocytogenes of 100 colony forming units per  gram (CFU/g) in foods that do not support growth of the microorganism. On May  24, 2004, FDA published a notice the Federal Register announcing the availability  of the Petition and requested comments until August 9, 2004. The Agency is  now in the process of responding to the Citizens' Petition. 
Objective 5: Enhance Disease Surveillance and OutbreakResponse- FDA participates in PulseNet, a national molecular subtyping network forfoodborne disease surveillance, which was established by the Centers forDisease Control and Prevention (CDC) in 1996.  Food and environmental bacterialpathogens, including Lm, are subtyped and characterized using pulsed-field gelelectrophoresis (PFGE) by FDA Office of Regulatory Affairs (ORA) laboratoriesand the molecular patterns are submitted by FDA CFSAN to PulseNet.  Thesepatterns are routinely compared to the PulseNet database that primarily consistsof patterns from clinical isolates.  Patterns from the food and clinicalisolates that "match" suggest a potential link and are further investigated todetermine if there is an epidemiological association in a foodborne outbreak. FDACFSAN routinely monitors the PulseNet listserv as a possible early alert to afoodborne outbreak.
- FDA CFSAN and FDA's ORA are more actively conducting follow-upinvestigations when there is a match between a food and clinical PFGE patterninvolving single cases of listeriosis to determine if there is an epidemiologicallink with an FDA regulated product.
- FDA CFSAN has a staff person located at CDC's Food Safety officein Atlanta, Georgia.  This on-site relationship facilitates communication and providesearly alerts to foodborne outbreaks involving FDA regulated products.
- FoodNet is developing a manuscript based on a 3 year case/controlstudy for risk factors associated with Lm infection. On multivariate analysisin the draft manuscript, melons eaten outside the home and hummus eaten outsidethe home were risk factors. 
- Preliminary FoodNet data for 2004 shows a trend for Lm incidencerates that is declining and approaching the Healthy People (HP) 2010 goal of0.25 cases per one hundred thousand population. The original HP2010 baselineline (1997) for Lm was an incidence of 0.5 cases per 100,000, and the 10 yeartarget was a 50% reduction to 0.25 cases per 100,000.The National Food SafetyStrategic Plan baseline (1997) for Lm was an incidence of 0.5 cases per 100,000and the 5 year goal was a 50% reduction to 0.25 cases per 100,000. -  Afterre-analysis  of the FoodNet data, the baselines and targets for HP2010 forLm have been revised: The revised HP2010 baseline line (1997) for Lm is anincidence of 0.47 cases per 100,000, and the 10 year target is a 50% reductionto 0.24 cases per 100,000.
- FoodNet has tested and implemented a new Lm surveillance formwhich is applied to each case of Lm occurring in FoodNet sites.  Information onthe form obtained in prospective interviews includes food consumptionhistories.  This information is used to help rapidly identify food vehicles inLm outbreaks detected through PulseNet.  Many states other than FoodNet sitesare also using this new surveillance form.
Objective 6: Coordinate research activities to refinethe Risk Assessment, enhance preventative controls, and support regulatory,enforcement, and educational activities.- Use the Lm risk assessment to focus Lm coverage in field programsnamely to focus on high risk products as determined by the risk assessment.
- Of the 57 Mexican personal cheese importations tested fromSeptember 2 to October 2, 2003 during an FDA blitz at the Mexican border; 39(68%)of the 57 were determined to be made from raw milk, 32(56%) of the 57 werepositive for generic  Escherichia  coli , 32(56%) of the 57 werepositive for  Staphylococcus aureus , 7(12%) of the 57 were positive for  Salmonella spp., and 5(8%) of the 57 were positive for Lm.  All isolations were confirmedby FDA laboratory analysis.
- Docket No. 2005N-0065. Published 3-4-05.  Notice for request for comments and for scientific data and information concerning foodborne  Listeria monocytogenes  in smoked finfish, and evaluation of  Food Code  provisions that address preventive controls for Lm in retail and foodservice establishments. Submitted comments are in review at FDA/CFSAN.
- CFSAN is conducting Microbiological Research for Support of Provisionsof the U.S.  Food Code . This includes the growth of Lm in ready to eat (RTE)deli salads and verification of instantaneous cook temperatures recommended inthe U.S.  Food Code.
- Two research projects are being conducted at CFSAN. The first isto examine the competition between Lm and spoilage microorganisms in both purecultures in broth and in foods. This will help explain the behavioral interactivitybetween spoilage flora and Lm .  The second is to model the lag phase ofLm cells that are in different physiological states (i.e., exponential growth,stationary, desicated, frozen) when placed in broth under differing headspacecarbondioxide levels.  This research will assist in the understanding of Lm asit relates to the modified atmosphere packaging area. 
- Current Lm  research at FDA's National Center for FoodSafety and Technology (NCFST).  Recovery of  Listeria monocytogenes  fromenvironmental swabs (transport media).  Same day identification of Lm using Pathatrixseparation and concentration and real-time PCR. 
- Joint Institute of Food Safety and Applied Nutrition (JIFSAN)collaborative work with University of Maryland Eastern Shore (UMES). Recentpublication "Yoon, K.S., C.N. Burnette, K.A. Abou-Zeid, and R. C. Whiting, 2004.Control of growth and survival of Lm on smoked salmon by combined potassium lactateand sodium diacetate and freezing stress during refrigeration and frozen storage.J. Food Protect., Vol. 67, No. 11. Pages 2465-2471.
- Supplemental quantitative risk assessment for Lm in smokedseafood to determine the steps in its production, distribution, sale, and usethat contributes to the risk of listeriosis and the potential risk reductionthat can be controlled by different mitigation strategies. 
- Health Canada has requested CFSAN's assistance in conducting a joint evaluation  of Lm associated with Soft and Semi-soft Cheese (particularly cheese made from  raw, unpasteurized milk). 
- FDA/CFSAN developing a risk profile for Lm in fresh-cut vegetables The risk profile will provide: (1) a review of the available information and identification of  major knowledge gaps for the purpose of research planning and priority setting.  This information will provide background knowledge needed by Agency risk managers to identify new approaches to controlling this pathogenic foodborne bacterium, and to develop effective food safety guidance for the industry and consumers.
- FDA/CFSAN is in the process of developing a risk profile for Lm insoft cheeses to determine potential strategies for risk reduction with theseproducts. 

Quantitative Assessment of Relative Risk to Public Healthfrom Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods

FDA Food Code
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