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FDA’s Response to a Multi-State Listeria monocytogenes Foodborne
Illness Outbreak Associated with Consumption of Fresh Whole
Cantaloupe, 2011
Sheila P. Merriweather, MPH
Coordinated Outbreak Response and Evaluation (CORE) Network
206/20/2012
Outline
• Perspectives on Listeria monocytogenes
• CORE
• Timeline of outbreak
• FDA response to outbreak– Environmental assessment
• Conclusions
306/20/2012
Listeria monocytogenes
• Not a typical foodborne disease or organism – Sporadic and rare although severe
• Nearly 1,600 foodborne illnesses annually1
– 1,400 hospitalizations and 250 deaths
• High morbidity and mortality rate within susceptible populations
– Causes meningitis, septicemia and abortion– Long incubation period– Psychrotrophic organism
1. Scallan E, et al. (2011) EID, 17 No. 1
Perspectives on Listeria monocytogenes
• Foodborne outbreaks historically associated with deli meats, unpasteurized cheese, raw milk, smoked fish, fresh-cut fruit and fresh-cut vegetables
• Typically thought of as a food processing plant environmental contaminant
• Known sources:• ruminant animals (e.g. cattle, goats, deer)• decaying vegetation – contributes to soil • cold, wet, difficult to clean areas
506/20/2012
FDA Coordinated Outbreak Response & Evaluation (CORE)
• Officially launched on August 1, 2011• Addresses illnesses due to FDA-regulated
human and animal food• Goal is to streamline incident-related
processes and to enhance transparency• For more info, see:
http://www.fda.gov/Food/FoodSafety/CORENetwork/default.htm
Coordinated Outbreak Response & Evaluation (CORE)
A dedicated multidisciplinary cadre of FDA personnel focused on:
Signals and Surveillance Team (SST): foodborne illness early signal detection and monitoring
Response Teams (n=3): Rapid and coordinated response associated with a foodborne illnesses outbreak
Post-Response Team:• Environmental Assessment• Process Improvement• Inform Agency Policy • Inform Industry Regarding Best Practices
706/20/2012
7777
Chief Medical OfficerDr. Kathleen Gensheimer
Chief Medical OfficerDr. Kathleen Gensheimer
Deputy DirectorRADM Brenda Holman
Deputy DirectorRADM Brenda Holman
Prevention Manager
Donald Kautter
Prevention Manager
Donald Kautter
Response Manager
Roberta Hammond
Response Manager
Roberta Hammond
CommunicationsSpecialist
CommunicationsSpecialist
CommunicationsSpecialist
CommunicationsSpecialist
CommunicationsSpecialist
CommunicationsSpecialist
Response Team 3Supervisor/LeaderResponse Team 3Supervisor/Leader
Response Team 2 Supervisor/LeaderResponse Team 2 Supervisor/Leader
Response Team 1Supervisor/LeaderResponse Team 1Supervisor/Leader
Post Response Team
Leader (EH)
Post Response Team
Leader (EH)
Signals Team Leader(EPI)
Signals Team Leader(EPI)
Information Management
Specialist
Information Management
SpecialistDoc Control/Data
Management/Information Management Specialist
Doc Control/Data Management/Information Management Specialist
CORE Network Organizational Structure
806/20/2012
Timeline of Outbreak• CORE Signals and Surveillance Team
– Friday, September 2, 2011• CORE Signals first learned of a possible Listeria
outbreak in Colorado via an open-source news story prior to Labor Day weekend (September 3-5, 2011). According to this story, the CO Dept of Public Health and Environment (CDPHE) issued press within the state about a spike of 9 Listeria cases in the month of August; there was no known vehicle and no report of cases in other states besides Colorado.
906/20/2012
Timeline of Outbreak• CORE Signals and Surveillance Team
– Tuesday, September 6, 2011• Information requested of CFSAN PFGE team
– Among 8 CO isolates uploaded to PulseNet during last 60 days, 6 distinct PFGE patterns were identified
• FDA Denver District Office notified • PulseNet officially recognized outbreak and
assigned cluster code 1109COGX6-1– Included 4 distinct PFGE patterns
• CO suspects the vehicle is cantaloupe
– Wednesday, September 7, 2011• Incident transferred to CORE Response Team 2
State of Colorado
1106/20/2012
Initial FDA Response• FDA Denver District Office (DEN-DO)
collected whole fresh cantaloupe at various retail locations around Denver on Friday, Sept 9, 2011
• Inspection at Jensen Farms packing house on Saturday, Sept 10, 2011– Jointly conducted with CDPHE– Firm in production
1206/20/2012
Initial FDA Response• Regulatory inspection (unannounced) at Jensen Farms
packing house – Sept 10, 2011– Samples collected
• Environmental swabs• Whole, fresh cantaloupe from cooler• Municipal water from processing line
– Laboratory results released on Sept 19, 2011• 13/39 environmental swabs (“subs”) yielded Listeria
monocytogenes• 5/10 cantaloupe (“subs”) yielded Listeria monocytogenes• Water sample was negative for Listeria
– For additional information: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/ucm276709.htm
1306/20/2012
FDA Response• Jensen Farms voluntarily recalled its entire
2011 production season of whole cantaloupe on Sept 14, 2011– Production dates
• End of July to Sept 10, 2011
– Distributed to 17 states initially– Prior to laboratory confirmation
• Additional recalls– Carol’s Cuts LLC on Sept 23, 2011– Fruit Fresh Up, Inc. on Oct 6, 2011
1406/20/2012
FDA Response
• Environmental Assessment (EA)– To identify potential contributing factors that
led to the introduction, growth and spread of Listeria monocytogenes within the premises
– Use data and information collected to assist the Agency to develop new policy or formulate regulatory approaches for industry to address issue
1506/20/2012
Environmental Assessment• Identified as a key activity to implement
President’s Food Safety Working Group• Firm approved this additional follow up
– Non-regulatory– Personnel headed to CO on Sept 20, 2011
• EA conducted on Sept 22 and 23• Report of findings published on FDA website on
October 19, 2011: http://www.fda.gov/Food/FoodSafety/FoodborneIllness/ucm276247.htm
Environmental Assessment Team Approach
Multi-jurisdictional
FDA Denver District Office
FDA CFSAN
Colorado Dept. of Public Health
Colorado Dept. of Agriculture
Prowers County Dept. of Health
Multi-disciplinary
Epidemiologists
Veterinarians
Produce Safety
Agriculturalists
Sanitarians
Environmental Assessment Approach
Information Sharing Among Team Members DEN-DO and State of CO visit to firm on 9/10/11 investigation and sample collection
Identification of Information Needs FDA Farm Questionnaire Supplemental Clarification Questions
Hypothesis Generation (using local expertise)
Sampling Plan Development
1806/20/2012
Firm Interview• Ask about farm locations / acreages• Use of food safety plan• Organic / Conventional / Transitional• Land use
– Adjacent land use as well• Practices• Soil amendments• Water use• Animal incursion• Worker health and hygiene
1906/20/2012
Ag Inputs
Cantaloupe
Soil Amendments Adjacent Land UseAg Water
Practices Worker Health &Hygiene
Potential Environmental Contributing Factors: • Rainfall events
Alfalfa/Cattle
Leased/Owned
Biosolids UseNPK Fertilizer
Plastic on Top of Soil
Well
Standing Water
Crop Protector Sprays
Drip Line
Animal Intrusion
Assessment or Exclusion
Other
Cattle Operator
Conservation Area
Domestic Animal Grazing
DeerOrganic /Transitional
Equipment Share
Drip/Plastic (used or new)
Seeds
Fumigation
Cantaloupes Restrooms - Handwashing (Training) - Waste Disposal
Soil under plastic
S
SS
S
S
S
SS
S
Agricultural Production Operations
S= Sampling Points
2006/20/2012
Samples Collected on Farm – 9/22/2011
Whole cantaloupeAnimal excreta
Soil• Also water
(irrigation & reservoir) and
• Drag swabs
2106/20/2012
Harvest Operations
Cantaloupe Packinghouse Fruit
Tools EquipmentCleaning & Sanitation
Practices Worker Health &Hygiene
Transport
Lm Sources: • Ruminant Animals• Decaying Vegetation (e.g. silage)
Potential Environmental Contributing Factors: • Rainfall events
Harvest Bins and padding
Conveyors/ Boom
Storage - Tractor - Conveyor - Gondola
Water Used
Shade Storage
Equipment (Gondola, Boom)
Frequency – 1x week?
Multiple Harvest
Pickup and Trailer
Contracted
Restroom/Handwashing
Gloves
S
S
= sample site
S
S
Employees
Equip. other purposes?
2206/20/2012
Postharvest Operations
Packinghouse Fruit
PackedFruit
Water EquipmentCleaning & Sanitation
Practices Worker Health &Hygiene
Animal Intrusion
Lm Sources: • Animals• Decaying Vegetation (e.g. silage)• Fruit
Potential Environmental Contributing Factors: • Animal access off season• Storage temperature and relative humidity
Potato Farm
Power Wash/Sanitizer
Single Pass
Inside Brush System
Granada - City Water
Documents - Master Sanitation - SOP’s - (Sign Off)
Manure Used for Production?
Insects - Flies
Sponge Rollers/Brushes
Bumper/Sponges
Post Harvest Cooling
Pack Table
Product Temperature
Organic Degreaser
Disposal
Cooler Temperatures
Garments/Gloves
Toilets - Handwashing - WaterRollers, Replaced
During Season?
Cattle Feed Truck
S = sample site
S
S
S
S Melons S
2306/20/2012
Packinghouse Observations
1) Facility & Equipment Sanitary Design• Refrigeration unit condensate line improperly drained
directly onto packinghouse floor and under equipment• Unsealed concrete floor that pooled water with slit trench
drain• Wet brush washer and drying rollers were new for 2011;
equipment formerly used to handle potatoes • Un-sanitizable felt/sponge rollers may have facilitated
inoculation of fruit• Wet brushing process may remove barriers to Lm entry
into the fruit and/or mechanically forced Lm into the fruit rind.
Potential Contributing Factors
2406/20/2012
Brush Washer Felt/Sponge Roller Dryer
Packinghouse ObservationsPotential Contributing Factors
2506/20/2012
2) Postharvest Handling Procedures• Use of wet brush wash and felt/sponge drying roller
equipment may have mechanically damaged and/or inoculated cantaloupe surfaces
• Pre-cooling to remove field heat before cold storage may have been inadequate (no forced air or hydro-cooling)
• No cantaloupe temperature monitoring in cold storage• Inadequate cantaloupe drying before cold storage• Inadequate cleaning and sanitation of food contact
surfaces (design and implementation)
Packinghouse ObservationsPotential Contributing Factors
2606/20/2012
9/22/11 Packinghouse Environmental Sampling
• Brush washer equipment assembly• Condensate drain line• Wall adjacent to condensate drain line• Floor / pipe recess below condensate drain line• Cantaloupe in cold storage
Sample Results (n=19 total): • Environmental samples: Listeria not detected in
samples collected on 9/22/11• Cantaloupes in cold storage: yielded Listeria
monocytogenes with a PFGE pattern indistinguishable from the outbreak strain(s)
2706/20/2012
Additional FDA Response• Warning Letter
– Issued on October 18, 2011• Explained epidemiological data and laboratory findings
from initial inspection on September 10– Cantaloupe identified as adulterated per the Federal Food,
Drug and Cosmetic Act
• Firm instructed to address violations
• Stakeholder calls– 3 calls on October 18, 2011: states, industry, and
consumer groups
• Recall audit checks
2806/20/2012
FDA Response• Current status of firm
– Jensen Farms filed for Chapter 11 bankruptcy on May 25, 2012
• In response to, at least, 19 wrongful death and personal injury lawsuits filed
• Lawsuits also pending against distributor, 3rd-party auditors and retail grocers that sold the cantaloupe
• In response to outbreak, Rocky Ford Growers Association created– Biannual safety audit checks to be conducted by CO
Dept of Ag officials
2906/20/2012
Conclusions• Based on epidemiologic and laboratory data, in
addition to state and federal investigational findings, the source of this nationwide listeriosis outbreak was whole fresh cantaloupe produced and packed at Jensen Farms, Colorado
• No one source of contamination was identified• Several contributing factors led to proliferation of
organism within packing facility
3006/20/2012
Conclusions
• This incident was the first Listeria monocytogenes foodborne illness outbreak associated with a whole fruit or vegetable (raw agricultural commodity)• Previous outbreaks involved fresh cut fruit or
vegetables – celery in 2010; sprouts in 2009
• Largest Listeria monocytogenes outbreak ever reported• Deadliest as well
3106/20/2012
Persons infected with the outbreak-associated strains of Listeria monocytogenes, by states, 2011 (n=146)
Source: CDC
3206/20/2012
Information Resources
• FDA posting re: Jensen Farms whole cantaloupes: http://www.fda.gov/Food/FoodSafety/CORENetwork/ucm272372.htm
• CDC web posting of outbreak: http://www.cdc.gov/listeria/outbreaks/cantaloupes-jensen-farms/120811/index.html
• FDA Guidance for Industry – cantaloupe (Nov 2011): http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm278456.htm
3306/20/2012
Resources
• US House of Representatives, Committee on Energy and Commerce, Jan 2012: http://republicans.energycommerce.house.gov/Media/file/PDFs/011012listeriastaffreport.pdf– In response to Committee staff meetings with FDA and CDC
on Oct 19, 2011; Primus Labs on Nov 7, 2011; Eric and Ryan Jensen on Nov 8, 2011; Frontera Produce on Nov 18, 2011; with FDA only on Dec 8, 2011; and Bio Food Safety on Jan 6, 2012 (via phone; 3rd party audit discussion).
3406/20/2012
Acknowledgements
• State of Colorado– Department of Agriculture– Department of Public Health & Environment– Prowers County Health Department
• FDA Denver District Office
• US Centers for Disease Control and Prevention
3506/20/2012
Questions?
CAPT Sheila P. Merriweather, MPH
Food and Drug Administration
Coordinated Outbreak Response & Evaluation (CORE) Network, Post Response Team
4300 River Road, Room 3109, HFS - 015
Riverdale, MD 20770
Phone: 240-402-3034 Fax: 301-436-3221
Email: [email protected]