Spinach Outbreak as Part of Broader Concerns about

Produce Safety – A FDA Perspective

Robert L. Buchanan, Ph.D.DHHS Food and Drug Administration

Center for Food Safety and Applied Nutrition

Presentation

Goal:1 To put the current spinach outbreak in

context as part of the almost decade- long FDA initiative to improve the microbiological safety of produce

2 Identify 1• Successes 2• Improved understanding of factors affecting

produce safety 3• Continuing challenges 4• Need for integrated programs

Presentation

1 Historical perspective – Major events

2 Current situation

3 Commodity specific associations

4 Research foundation

5 Concluding remarks

Historical Perspective

Identification of Increased Incidence of Produce Related Outbreaks in Early 1990s

25

Fruits

20

Vegetables

15

10

5

074

7678

8082 84 86 88 90

Two year period beginning in year

Source: CDC Foodborne

outbreak surveillance system

Early Food Safety Outbreaks

1 Unpasteurized Juices 1 Salmonella, Escherichia coli O157:H7,

Cryptosporidium parvuum

2 Sprouted Seeds 1 Salmonella, Escherichia coli O157:H7

3 Berries 1 Cyclospora cayetanensis

4 Leafy vegetables 1 Escherichia coli O157:H7, Salmonella,

Shigella

Historical Perspective

1 1997. Multiple government agencies launch the National Food Safety Initiative (FSI)

2 1997. Several outbreaks associated with fresh and fresh-cut produce and sprouted seeds lead to the expansion of FSI to include the Produce and Imported Food Safety Initiative (PIFSI)

3 1998. Labeling of fresh, untreated juices

Historical Perspective

1 1998. Guidance on “Critical Controls for Juice Safety” 1998. FDA publishes “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables”

2 1999. FDA publishes guidance for the production of safe sprouts

3 2001. Final “Juice HACCP Rule” publishes

Current Situation

Current Situation1 Continue to have

outbreaks associated with produce 1 Bacterial – Primary

Production?

2 Viral – Food service sector?

2 Largely associated with specific fruits and vegetables

Category Outbreaks Illnesses

Processed 43 3,026

Produce 63 8,040

Sprouts 25 1,565

Seafood 120 2,567

Eggs 234 6,572

1998-2006* Produce Outbreaks by Commodity

Tomatoes 11 Green onions 3

Cantaloupe 7 Mango 2

Melons 1 Almonds 2

Honeydew melon 2 Parsley 1

Raspberries 5 Basil 4

Romaine lettuce 4 Green grapes 1

Lettuce 10 Snow Peas 1

Mixed lettuce 1 Basil or Mesclun 2

Cabbage 1 Squash 1

Spinach 1 Unknown 3

*as of August 7, 2006

1998-2006 Produce Outbreaks

1 5 commodity groups make up >75 percent of produce related outbreaks

Commodity % produce outbreaksLettuce/leafy greens 30%Tomatoes 17%Cantaloupe 13%Herbs (Basil, parsley) 11%Green onions 5%

Total % of 5 top commodities 76%

1 Association with specific geographical locations and growing seasons 1 Enterohemorrhagic Escherichia coli –

Lettuce/Spinach – California - Fall crop 2 Salmonella spp. – Tomatoes – Eastern United

States 3 Salmonella spp. – Cantaloupes – Mexico 4 Cyclospora cayetanensis – Raspberries -

Guatemala - Spring crop 5 Salmonella Enteritidis – Almonds – California 6 Salmonella – Mangoes - South America

Success Stories?

1 Cantaloupes: 1 Worked with Mexico to establish mandatory GAP

program for product exported to U.S.

2 Raspberries: 1 Worked with Guatemala to develop a mandatory GAP

program for product exported to U.S.

3 Mangoes: 1 Change the way mangoes heat treated for Med fly larva

4 Sprouts: 1 Guidance on seed treatment and irrigation water

testing

5 Raw Almonds: 1 Implementation of bactericidal treatment

Ongoing Challenges

1 Leafy Greens 2 Tomatoes 3 Green Onions 4 Cantaloupe 5 Parsley, Cilantro,

Culantro

1995 3 - E. coli O157:H7 105cases

1996 2 - E. coli O157:H7 68cases

1997 1 - Cyclospora 12cases

1998 2 - E. coli O157:H7 6cases

1999 6 - E. coli O157:H7 86cases

2002 2 - E. coli O157:H7 53cases

2003 3 - E. coli O157:H7 60cases

2004 2 - Cyclospora 95cases

1 - Salmonella 79cases

1 - E. coli O157:H7 6 cases

2005 1 - E. coli O157:H7 32cases

2006 1 – E. coli O157:H7 191 cases

Tomato Outbreaks

1998 S. Baildon 86 cases 2000 S. Thompson 29 cases 2002 S. Newport 512 cases

S. Newport 12 casesS. Javiana 90 cases

2004 S. Javiana 471 casesS. Braenderup 123 cases

2005 S. Newport 71 casesS. Braenderup 73 cases

S. Enteritidis 73 cases

Recent Activities1 2004. FDA Produce Safety Action

Plan 2 2005. Public meeting on sprout

safety 3 2005 - 2006. Work with industry on

commodity specific guidelines Melons, Lettuce and Leafy Greens,

Fresh Tomatoes

4 2006. Meet with tomato industry on need to control Salmonella

5 2006. Lettuce Initiative

Produce Safety Research

Produce Safety Research1 During the past 10 years, government

and industry invested in increased intramural and extramural research activities in areas of

1 Detection of pathogens on produce 2 Microbial ecology of produce 3 Sources of contamination 4 Growth of pathogens on produce 5 Assessment of potential intervention

technologies 6 Risk assessment

Manure and Sewage Sludge Management

1 Inadequately treated animal and human waste are potentially important sources of contamination for produce 1 Run-off can

disseminate

2 Desiccated feces can be airborne

Contamination of Agricultural Waters

1 Irrigation and other agricultural water can be a major source of contamination of produce

2 Identification of point and non-point sources of microbial contamination is foundation for reducing risks associated with irrigation waters

Water as a Source of Enteric Pathogens

1 Irrigation techniques that bring water into direct contact with produce increase potential for contamination

2 Affected by the topographical characteristics of produce

Topography of Produce Influences Potential for Contamination1 Leafy vegetables tend to have elevated

levels of bacteria due to large surface area 2 Bacteria tend to accumulate in certain

areas or structures (e.g., stomata) 3 Bacteria tend to adhere and accumulate at

cut surfaces 4 Once internalized, pathogens are difficult to

remove 5 Leafy vegetables can support the growth of

pathogenic bacteria including E. coli O157:H7

Personal Hygiene of Farm Workers

1 As with any food worker, farm personnel can be a source of contamination

2 Need adequate training and supervision in appropriate hygiene

Animals as a Source of Enteric Pathogens1 In addition to

domestic animals, feral animals can also be a source of human pathogens 1 Deer

2 Birds

3 Insects

4 Reptiles

5 Amphibia

2 Importance as vector unknown

Internal Contamination of Produce

1 Infiltration can occur during harvesting and processing

2 Some studies suggest that infiltration through root system or during flowering may lead to the presence of pathogens, including E. coli O157:H7 in mature plant

3 Infiltration impacts efficacy of potential post- harvest treatments

Removing Contamination from Produce

1 Washing helps reduce levels of pathogens adhering to surfaces of produce but only to a limited degree

2 Washing has little effect if pathogens are internalized

3 Wash water can serve as a vector or a vehicle for cross-contamination

Produce Safety Research

1 This scientific information is the basis for evolving guidance 1 Guide to Minimize Microbial

Food Safety Hazards For Fresh Fruits and Vegetables, October 1998

2 Updated version out for comment

3 Commodity specific guidance developed by industry

2 Also basis for questions posed in epidemiological evaluations

Epidemiological Investigations of Outbreaks

1 Use data to identify factors that may contribute to outbreaks

2 Provide advice on priority research areas

3 Identify issues such as 1 Environmental

conditions

2 Handling practices

3 Geographical setting

4 Seasonality

Concluding Remarks1 FDA is committed to ensuring the produce

consumed in the United States is safe and that public health is protected

2 FDA is committed to working with the industry, the research community, and other interested stakeholders to find solutions to this public health concern so that consumers can have confidence in this important part of a healthy diet

3 Need for an integrated approach