Caroline Smith DeWaal Center for Science in the Public Interest Washington, DC May 17, 2005 May 17, 2005 CFSAN Sprout Safety Public Meeting.

Caroline Smith DeWaalCaroline Smith DeWaalCenter for Science in the Public InterestCenter for Science in the Public Interest

Washington, DCWashington, DC May 17, 2005May 17, 2005

CFSAN Sprout Safety Public MeetingCFSAN Sprout Safety Public Meeting

IntroductionIntroduction

1999 Sprout Guidance Documents 1999 Sprout Guidance Documents were a step in the right directionwere a step in the right direction

The effect seen on food-borne The effect seen on food-borne illnesses was not sustainedillnesses was not sustained

Further action, along with a longer-Further action, along with a longer-term strategy, is neededterm strategy, is needed

FDA QuestionsFDA Questions

Should the Sprout Guidance Should the Sprout Guidance Documents be expanded or revised?Documents be expanded or revised?

Is a regulation likely to be effective in Is a regulation likely to be effective in reducing food-borne illness linked to reducing food-borne illness linked to sprouts?sprouts?

How can progress be measured?How can progress be measured?

Expanded or Revised Expanded or Revised Guidance?Guidance?

Guidance recommendations should Guidance recommendations should be made mandatorybe made mandatory

Several of the recommendations in Several of the recommendations in the guidance should be more specific the guidance should be more specific and detailedand detailed

Effectiveness of a Regulation?Effectiveness of a Regulation?

A regulation would be more effective in A regulation would be more effective in addressing sprout safety:addressing sprout safety:

Legal requirement to institute Legal requirement to institute preventive controlspreventive controls

Ensures universal adoption of FDA Ensures universal adoption of FDA recommendationsrecommendations

Measuring Progress…Measuring Progress…

FDA should determine how FDA should determine how successful the microbial testing successful the microbial testing guidance has been since issued ANDguidance has been since issued AND

Identify the proportion of industry Identify the proportion of industry who followed the sampling and who followed the sampling and testing guidelinestesting guidelines

Testing results should be published Testing results should be published and be readily accessible to the and be readily accessible to the publicpublic

Unique DataUnique Data

CSPI tracks food-borne illness outbreaks with CSPI tracks food-borne illness outbreaks with the the Outbreak Alert!Outbreak Alert! database database

Contains almost 4,500 outbreaks with both known Contains almost 4,500 outbreaks with both known food source and known etiology which occurred in food source and known etiology which occurred in the U.S. between 1990-2003the U.S. between 1990-2003

Only source for outbreaks linked to specific foods, Only source for outbreaks linked to specific foods, as well as specific pathogensas well as specific pathogens

Outbreaks are grouped according to U.S. Outbreaks are grouped according to U.S. regulatory agency and placed in one of 13 food regulatory agency and placed in one of 13 food categoriescategories

Number of Outbreaks By Year and Number of Outbreaks By Year and Regulating Agency, 1990-2003Regulating Agency, 1990-2003

0

100

200

300

400

500

600

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

Year

Nu

mb

er

of

Ou

tbre

ak

s

FDA USDA Both

EFORS Implemented

Source: Outbreak Alert! Center for Science in the Public Interest, 2004

Trends in Outbreak Reporting:Trends in Outbreak Reporting:Produce 1990-2003Produce 1990-2003

0

20

40

60

80

100

Year

Num

ber

of

Out

brea

ks

0

500

1000

1500

2000

2500

3000

3500

Num

ber

of C

ases

Outbreaks Cases

Source: Outbreak Alert! Center for Science in the Public Interest, 2004

Top Causes of Produce Outbreaks, Top Causes of Produce Outbreaks, 1990-20031990-2003

0

25

50

75

100

125

150

175

200

Norovirus Salmonella OtherBacteria

Cyclospora OtherViruses

Escherichia Other OtherParasites

Etiology

Num

ber

of O

utbr

eaks

0

1000

2000

3000

4000

5000

6000

7000

8000

Num

ber

of C

ases

Outbreaks Cases

Source: Outbreak Alert! Center for Science in the Public Interest, 2004

Causes of 29 Sprout OutbreaksCauses of 29 Sprout Outbreaks1990-20031990-2003

CauseCause # Outbreaks# Outbreaks # of Cases# of Cases

EscherichiaEscherichia

E. coliE. coli O157:H7 O157:H7

E. coliE. coli O157:NM O157:NM

55

33

22

141141

120120

2121

SalmonellaSalmonella

S.S. Anatum Anatum

S.S. Chester Chester

S.S. Enteritidis Enteritidis

S.S. Havana, S. Cubana, S. Tennessee Havana, S. Cubana, S. Tennessee

S.S. Infantis, S. Anatum Infantis, S. Anatum

S.S. Kottbus Kottbus

S.S. Mbandaka Mbandaka

S.S. Montevideo, S. Meleagridis Montevideo, S. Meleagridis

S.S. Muenchen Muenchen

S.S. Newport Newport

S.S. Saint Paul Saint Paul

S.S. Senftenberg Senftenberg

S.S. Stanley Stanley

S.S. Typhimurium Typhimurium

Salmonella spp.Salmonella spp.

2424

11

11

44

11

11

11

11

11

22

22

22

11

22

11

33

19481948

1515

2626

244244

4040

109109

3232

8383

650650

9999

202202

5252

6060

158158

119119

5959

Source: Outbreak Alert! Center for Science in the Public Interest, 2004

Summary of an OutbreakSummary of an Outbreak

February – April 2001: Multi-stateFebruary – April 2001: Multi-state SalmonellaSalmonella Kottbus linked to alfalfa Kottbus linked to alfalfa

sprout consumptionsprout consumption 32 cases of food-borne illness32 cases of food-borne illness Single imported seed lot from a Single imported seed lot from a

single sprout producersingle sprout producer Seeds had undergone a Seeds had undergone a

decontamination treatmentdecontamination treatment

CSPI RecommendationsCSPI Recommendations

Keep the seeds intended for Keep the seeds intended for agricultural use and those intended agricultural use and those intended for human consumption separatedfor human consumption separated

Encourage development of better Encourage development of better decontamination methodsdecontamination methods

Greater government oversight of Greater government oversight of sprout industrysprout industry

Consumer warning labelsConsumer warning labels

Separate SeedsSeparate Seeds

The practice of using seeds that have The practice of using seeds that have been grown for agricultural use been grown for agricultural use should be bannedshould be banned

Seed imports from other regions Seed imports from other regions should only be allowed if produced should only be allowed if produced under similarly strict guidelinesunder similarly strict guidelines

Separate Seeds (cont’d)Separate Seeds (cont’d)

The practice of mixed batches should The practice of mixed batches should be banned for seeds intended for be banned for seeds intended for human consumptionhuman consumption

Batches of seeds and packages of Batches of seeds and packages of sprouts should be clearly labeled or sprouts should be clearly labeled or tagged throughout the food tagged throughout the food production chain from farm to tableproduction chain from farm to table

Decontamination MethodsDecontamination Methods

All decontamination methods should All decontamination methods should be challenge-tested with seeds be challenge-tested with seeds positive for positive for E. coliE. coli O157:H7 O157:H7

Clear and accurate information on Clear and accurate information on the effectiveness of the various the effectiveness of the various decontamination methods should be decontamination methods should be provided to the publicprovided to the public

Greater Government OversightGreater Government Oversight

Sprout processors should be Sprout processors should be registered and classified as food registered and classified as food handlershandlers

Sprout processing facilities should be Sprout processing facilities should be regularly inspected by both state and regularly inspected by both state and federal inspectorsfederal inspectors

FDA should take steps toward FDA should take steps toward applying HACCP principles to the applying HACCP principles to the sprout industrysprout industry

Consumer Warning LabelsConsumer Warning Labels

Effective package labeling to alert Effective package labeling to alert consumers of the risksconsumers of the risks

Label should be concise, easy-to-Label should be concise, easy-to-read, prominently placed, and read, prominently placed, and include a graphic symbol to aid include a graphic symbol to aid consumers in identifying and consumers in identifying and remembering the risksremembering the risks

ConclusionsConclusions

A sprout regulation is the next step A sprout regulation is the next step toward instituting consistent, toward instituting consistent, effective, preventive controlseffective, preventive controls

A longer-term strategy is needed, A longer-term strategy is needed, and consideration of HACCP and consideration of HACCP principles should be madeprinciples should be made

Don’t just warn, label!Don’t just warn, label!