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

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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

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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

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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

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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

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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

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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

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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

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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

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Samples Collected on Farm – 9/22/2011

Whole cantaloupeAnimal excreta

Soil• Also water

(irrigation & reservoir) and

• Drag swabs

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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

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Brush Washer Felt/Sponge Roller Dryer

Packinghouse ObservationsPotential Contributing Factors

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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

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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

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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

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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: Sheila.Merriweather@fda.hhs.gov