Public Meeting: Sprout Safety Michelle A. Smith, Ph.D. Center for Food Safety and Applied Nutrition Food and Drug Administration College Park, MD May 17,

Public Meeting: Public Meeting: Sprout SafetySprout Safety

Michelle A. Smith, Ph.D.Michelle A. Smith, Ph.D.Center for Food Safety and Applied Center for Food Safety and Applied

NutritionNutrition

Food and Drug AdministrationFood and Drug Administration

College Park, MDCollege Park, MD

May 17, 2005May 17, 2005

OutlineOutline

BackgroundBackground– Outbreaks, Collaborative effortsOutbreaks, Collaborative efforts– Consumer advisoriesConsumer advisories– Sprout guidance documentsSprout guidance documents– Observations: field assignments & Observations: field assignments &

investigationsinvestigations

Produce Safety Action PlanProduce Safety Action PlanQuestionsQuestions– Next stepsNext steps

Sprouts - a Special ProblemSprouts - a Special ProblemNACMCF NACMCF ProduceProduce White Paper 1998 White Paper 1998

NACMCF NACMCF 1998 1998 ProduceProduce White Paper White Paper

Fresh produce, including sprouts – Opportunities Fresh produce, including sprouts – Opportunities for contamination, e.g., production (agricultural) for contamination, e.g., production (agricultural) environment, subsequent handling, storage, environment, subsequent handling, storage, distribution & marketingdistribution & marketing

In additionIn addition - Germination conditions foster - Germination conditions foster bacterial growth bacterial growth

Treatments that inactivate pathogens may also Treatments that inactivate pathogens may also decrease germination, yield, or affect decrease germination, yield, or affect appearance of sprouts.appearance of sprouts.

Sprout Outbreaks 1996 - 2004Sprout Outbreaks 1996 - 2004 Alfalfa Clover Mung Bean CasesAlfalfa Clover Mung Bean Cases

19961996 (2) 1 (2) 1 1 1 65065019971997 (3) 3(3) 3 11 27727719981998 (3) 3(3) 3 11 48 4819991999 (6) 5(6) 5 22 38938920002000 (1) -(1) - -- 1 1 75 7520012001 (3) 1(3) 1 22 88 8820022002 (2) 1(2) 1 11 21 2120032003 (5) 5(5) 5 52 5220042004 (2) 2(2) 2 33 33Total: 27 OutbreaksTotal: 27 Outbreaks 1633 1633

casescases

Background – A Background – A FewFew Milestones Milestones

Sprouts identified as a problem by CDC in Sprouts identified as a problem by CDC in 1995 1995

Sprout work groups to identify and implement Sprout work groups to identify and implement safe production practices for seeds and safe production practices for seeds and sprouts, public mtg, sprout summit….sprouts, public mtg, sprout summit….

1997 FDA asked NACMCF to study sprouts1997 FDA asked NACMCF to study sprouts

1999 NACMCF Sprout White Paper1999 NACMCF Sprout White Paper

1999 FDA Sprout Guidance docs1999 FDA Sprout Guidance docs

NACMCF NACMCF 1999 1999 SproutSprout White Paper White Paper

Microbial Safety Evaluations and Microbial Safety Evaluations and Recommendations on Sprouted Recommendations on Sprouted Seeds - Adopted May 28, 1999Seeds - Adopted May 28, 1999Basis for FDA’s sprout guideBasis for FDA’s sprout guide

http:/vm.cfsan.fda.gov/~mow/http:/vm.cfsan.fda.gov/~mow/sprouts2.htmlsprouts2.html

International Journal of Food MicrobiologyInternational Journal of Food Microbiology, , November, 1999November, 1999

NACMCF Sprout White PaperNACMCF Sprout White Paper

SeedsSeeds are the most likely source of are the most likely source of microbial contamination. microbial contamination. Damaged or scarified seed may Damaged or scarified seed may increase the risk of internalization of increase the risk of internalization of pathogens and make disinfection more pathogens and make disinfection more difficult.difficult.5-log5-log seed disinfection treatment seed disinfection treatment should be applied to seed before should be applied to seed before sproutingsprouting

FDA’s Sprout GuidanceFDA’s Sprout GuidanceOctober 25, 1999October 25, 1999

1.1. Reducing Microbial Food Safety Hazards Reducing Microbial Food Safety Hazards for Sprouted Seeds for Sprouted Seeds

2.2. Sampling and Microbial Testing of Spent Sampling and Microbial Testing of Spent Irrigation Water During Sprout ProductionIrrigation Water During Sprout Production

http://vm.cfsan.fda.gov/~dms/sprougd1.htmlhttp://vm.cfsan.fda.gov/~dms/sprougd1.htmlhttp://vm.cfsan.fda.gov/~dms/sprougd2.htmlhttp://vm.cfsan.fda.gov/~dms/sprougd2.html

ObjectivesObjectives

Provide Provide recommendationsrecommendations to seed suppliers to seed suppliers and sprout producers about reducing and sprout producers about reducing microbial food safety hazards and sprout microbial food safety hazards and sprout associated illness, andassociated illness, and

Ensure all parties Ensure all parties comply with the food safety comply with the food safety provisions of the Food, Drug, and Cosmetic provisions of the Food, Drug, and Cosmetic ActAct

Federal Register Notice: GuidanceFederal Register Notice: Guidance

Failure to adoptFailure to adopt effective preventive controlseffective preventive controls can be considered can be considered insanitary conditionsinsanitary conditions

- FDA will consider enforcement actions - FDA will consider enforcement actions against any party who does not have against any party who does not have effective preventive controls in place, in effective preventive controls in place, in particular, microbial testingparticular, microbial testing

Broad Sprout GuideBroad Sprout Guide

Everyone has a responsibility:Everyone has a responsibility:1.1. Seed productionSeed production - Good Agricultural Practices - Good Agricultural Practices

(GAPs)(GAPs)

2.2. Seed conditioning, storage, and Seed conditioning, storage, and transportationtransportation - minimize contamination - minimize contamination

3.3. Sprout productionSprout production - Good Manufacturing - Good Manufacturing Practices (GMPs) should be standard Practices (GMPs) should be standard operating procedureoperating procedure


4.4. Seed treatmentSeed treatment - applying one or more - applying one or more approved treatments shown to reduce approved treatments shown to reduce pathogens prior to sproutingpathogens prior to sprouting((SUCH ASSUCH AS 20,000 ppm calcium hypochlorite) 20,000 ppm calcium hypochlorite)

5.5. Microbial testingMicrobial testing – testing spent irrigation – testing spent irrigation water from water from each batcheach batch of sprouts for of sprouts for pathogens pathogens beforebefore sprouts enter the food sprouts enter the food supplysupply

-- SalmonellaSalmonella - - E. coliE. coli O157:H7 O157:H7


Identifies Identifies the most important stepsthe most important steps which which should be implemented immediately should be implemented immediately to to reduce the risk of sprouts as a vehicle for reduce the risk of sprouts as a vehicle for illnessillness

Does Does notnot provide detailed information on all provide detailed information on all individual steps that should be followed to individual steps that should be followed to produce seeds and sproutsproduce seeds and sprouts– Resources and referencesResources and references– CDHS/FDA sprout video CDHS/FDA sprout video

Educational video produced and Educational video produced and

distributed by the CDHS – FDB and the distributed by the CDHS – FDB and the

FDA in cooperation with industry and FDA in cooperation with industry and

academia.academia.

http://www.cfsan.fda.gov/~dms/sprouvid.htmlhttp://www.cfsan.fda.gov/~dms/sprouvid.html

oror

http://www.dhs.ca.gov/fdb/PDF/SproutOrderFhttp://www.dhs.ca.gov/fdb/PDF/SproutOrderForm4.PDForm4.PDF

““Safer Processing of SproutsSafer Processing of Sprouts””

1999 Consumer Advisory*1999 Consumer Advisory** Updated Alfalfa sprout advisory August 31, 1998* Updated Alfalfa sprout advisory August 31, 1998

Advised all persons to be aware of the Advised all persons to be aware of the risks associated with eating [all] raw risks associated with eating [all] raw sprouts.sprouts.

People in high risk categories should People in high risk categories should not eat raw sprouts. not eat raw sprouts.

Persons wishing to reduce the risk of Persons wishing to reduce the risk of foodborne illness from sprouts should foodborne illness from sprouts should not eat raw sprouts.not eat raw sprouts.

Sprout Outbreaks 1996 - 2004Sprout Outbreaks 1996 - 2004 Alfalfa Clover Mung Bean CasesAlfalfa Clover Mung Bean Cases


casescases

Turning the corner w/ sprouts?Turning the corner w/ sprouts?

1999, a tough year1999, a tough year– Updated consumer advisoryUpdated consumer advisory– Issuance of direct final sprout guidanceIssuance of direct final sprout guidance– Initiated directed inspections sprout facilitiesInitiated directed inspections sprout facilities

2000, NO outbreaks associated with alfalfa 2000, NO outbreaks associated with alfalfa or clover sprouts,or clover sprouts,

However…..However…..

Sprout Outbreaks 1996 - 2004Sprout Outbreaks 1996 - 2004 Alfalfa Clover Alfalfa Clover Mung BeanMung Bean Cases Cases


casescases

2002 Updated Consumer Advisory2002 Updated Consumer Advisory

Advised all persons to be aware of the Advised all persons to be aware of the risks associated with eating raw risks associated with eating raw and lightly and lightly cookedcooked sprouts sprouts

Specifically included Specifically included mung bean sproutsmung bean sprouts

www.cfsan.fda.gov/~lrd/tpsprout.htmlwww.cfsan.fda.gov/~lrd/tpsprout.html

FDA 1998 Field AssignmentFDA 1998 Field Assignment

Target: 100 firmsTarget: 100 firms

GMP InspectionGMP Inspection (21 CFR part 110) (21 CFR part 110)– 83 firms83 firms

Survey QuestionnaireSurvey Questionnaire

GMP + demographicsGMP + demographics– 80 firms80 firms

Samples for microbial analysesSamples for microbial analyses

raw seed → finished productraw seed → finished product– 78 firms78 firms

FDA 1998 Inspection ResultsFDA 1998 Inspection Results

FDA-483 Report of Observations, issued when FDA-483 Report of Observations, issued when insanitary practices or conditions are observedinsanitary practices or conditions are observed

83 Facilities Inspected83 Facilities Inspected

FDA-483 Issued at FDA-483 Issued at 47 firms (57%)47 firms (57%)

FDA 1998 Microbial AnalysesFDA 1998 Microbial Analyses

FirmFirm Stage of growthStage of growth

AA RAW PRE GERM ----- RAW PRE GERM ----- FIN*FIN*

BB RAW PRE GERM ----- RAW PRE GERM ----- FIN*FIN*

CC RAW RAW PRE* GERM* WW*PRE* GERM* WW* FIN*FIN*

* (+) * (+) SalmonellaSalmonella sp., alfalfa sp., alfalfa

2000 Field Assignment2000 Field Assignment

Target: 150 firmsTarget: 150 firms

Limited InspectionsLimited Inspections (focus on practices in (focus on practices in guidance) guidance)

QuestionnaireQuestionnaire re: recommendations in re: recommendations in guidanceguidance

Collect and test spent irrigation waterCollect and test spent irrigation water from from firms that are testingfirms that are testing

2000 Inspection Results2000 Inspection Results

137 firms inspected:137 firms inspected:Good newsGood news No positive water No positive water samplessamplesBad newsBad news

- FDA-483 to 99 firms (72%)- FDA-483 to 99 firms (72%) - Warning letters 65 firms (47%)- Warning letters 65 firms (47%)

– Unsanitary conditionsUnsanitary conditions– Failure to implement effective controls, Failure to implement effective controls,

emphasis on microbial testingemphasis on microbial testing (Seed treatment still important)(Seed treatment still important)

2000 Directed Inspections2000 Directed Inspections

No significant deficiencies 54 firms (39%)No significant deficiencies 54 firms (39%)

Firms inspected in 1998 did better than Firms inspected in 1998 did better than firms not previously visitedfirms not previously visited

Deficiencies:Deficiencies:

Personnel cleanliness 20%Personnel cleanliness 20%

Unsanitary food contact surfaces 24%Unsanitary food contact surfaces 24%

Pests 28%Pests 28%

Water quality 28%Water quality 28%

Sprout Outbreaks 1996 - 2004Sprout Outbreaks 1996 - 2004 AlfalfaAlfalfa Clover Mung Bean Cases Clover Mung Bean Cases

19961996 (2) 1 (2) 1 1 1 65065019971997 (3) 3(3) 3 11 27727719981998 (3) 3(3) 3 11 48 4819991999 (6) 5(6) 5 22 38938920002000 (1) -(1) - -- 1 1 75 7520012001 (3) (3) 11 22 (32)(32) 88 8820022002 (2) (2) 11 11 (5) (5) 21 2120032003 (5) (5) 55 525220042004 (2) (2) 22 3333Total: 27 OutbreaksTotal: 27 Outbreaks 1633 1633

casescases

Adequacy of Current GuidanceAdequacy of Current Guidance

Some inspectors recent outbreak Some inspectors recent outbreak investigations reported “sprouter investigations reported “sprouter appearsappears to be following FDA sprout guidance.” to be following FDA sprout guidance.”

Questions:Questions:

Consistent and Appropriate application of Consistent and Appropriate application of recommended practices?recommended practices?

Adequacy of current guidance?Adequacy of current guidance?

California Sprout Industry California Sprout Industry Inspection – February 2004Inspection – February 2004

CDHS – FDB and FDA inspectors visited CDHS – FDB and FDA inspectors visited

every registered sprout grower in every registered sprout grower in

California California

A standardized questionnaire was used to A standardized questionnaire was used to

evaluate if practices consistent with evaluate if practices consistent with

current GAPs and GMPs guidance.current GAPs and GMPs guidance.

California 2004 - Inspection ChecklistCalifornia 2004 - Inspection Checklist

– Seed StorageSeed Storage

– Pest controlPest control

– Sprout ProductionSprout Production

– Seed TreatmentSeed Treatment

– Testing for PathogensTesting for Pathogens

– Storage and Distribution of SproutsStorage and Distribution of Sprouts

– Traceback CapabilityTraceback Capability

– Cleaning and DisinfectionCleaning and Disinfection

California 2004 - California 2004 - SanitationSanitation

50% of firms were described as having 50% of firms were described as having deficienciesdeficiencies including: including:

– unsanitary food contact surfaces (38%)unsanitary food contact surfaces (38%)

– evidence of pests (33%)evidence of pests (33%)

– lack of personnel cleanliness (25%)lack of personnel cleanliness (25%)

– water quality problems (8%)water quality problems (8%)

California 2004 - Seed TreatmentCalifornia 2004 - Seed Treatment

70% of sprouts were treated with 70% of sprouts were treated with Ca(OCl)Ca(OCl)2 2 * *

Sodium hypochlorite (25%), ozone, and Sodium hypochlorite (25%), ozone, and peroxyacetic acid were also used. peroxyacetic acid were also used.

* only 2 used the correct concentration, * only 2 used the correct concentration, duration, and method (e.g., agitation, duration, and method (e.g., agitation, seed:solution ratio)seed:solution ratio)

California 2004 - California 2004 - Sampling and Microbial Sampling and Microbial

Testing of Spent Irrigation WaterTesting of Spent Irrigation Water

71% of firms collected spent irrigation water 71% of firms collected spent irrigation water for microbial testingfor microbial testing

Almost all firms tested for Almost all firms tested for SalmonellaSalmonella spp. spp. and and E. coliE. coli O157:H7 but the testing method O157:H7 but the testing method varied greatly.varied greatly.

– ““unapproved” testsunapproved” tests

– Who does tests, whereWho does tests, where

– Pooling, holding samplesPooling, holding samples

CA 2004 - Confirmatory TestsCA 2004 - Confirmatory Tests11/17 (65%) conduct confirmatory testing 11/17 (65%) conduct confirmatory testing

following an initial positive test resultfollowing an initial positive test result

4/17 (24%) have never had an initial positive but 4/17 (24%) have never had an initial positive but

would conduct confirmatory testing if necessarywould conduct confirmatory testing if necessary

5/8 (63%) use spent irrigation water while 3/8 5/8 (63%) use spent irrigation water while 3/8

(38%) use enrichment media for conf. testing(38%) use enrichment media for conf. testing

Almost half wait to ship until the results have Almost half wait to ship until the results have

been received. been received.

California 2004California 2004Testing Spent Irrigation WaterTesting Spent Irrigation Water

Record KeepingRecord Keeping**

– 15/17 (88%) that conduct testing maintain 15/17 (88%) that conduct testing maintain

records of test results from 48 hour spent records of test results from 48 hour spent

irrigation water samples.irrigation water samples.

– 1/17 (6%) maintains a record of 48 hour spent 1/17 (6%) maintains a record of 48 hour spent

irrigation water samples collected but irrigation water samples collected but notnot the the

results.results.

*Data missing from 1 firm*Data missing from 1 firm

California 2004 – Record KeepingCalifornia 2004 – Record Keeping

Less than 20% that conduct confirmatory Less than 20% that conduct confirmatory testing maintain records of the positive testing maintain records of the positive results.results.

A majority of firms (92%) do A majority of firms (92%) do notnot maintain maintain records of the disposition of the product records of the disposition of the product where irrigation water is confirmed positive.where irrigation water is confirmed positive.

CA 2004 - Traceback CapabilityCA 2004 - Traceback Capability

17/24 (71%) of firms reported having the ability 17/24 (71%) of firms reported having the ability

to trace sprouts back to their source seed to trace sprouts back to their source seed

supplier.supplier.

Maximum number of seed lots used to produce Maximum number of seed lots used to produce

one finished product lot ranged from 1-10.one finished product lot ranged from 1-10.

12/24 (50%) of firms identify finished product 12/24 (50%) of firms identify finished product

with a lot number or date designation.with a lot number or date designation.

Produce Safety From Production to Produce Safety From Production to Consumption: 2004 Action PlanConsumption: 2004 Action Plan to to

Minimize Foodborne Illness Minimize Foodborne Illness Associated with Fresh Produce Associated with Fresh Produce

ConsumptionConsumptionOctober, 2004October, 2004

http://www.cfsan.fda.gov/~dms/prodpla2.http://www.cfsan.fda.gov/~dms/prodpla2.

htmlhtml

2005 CFSAN Program Priorities2005 CFSAN Program Priorities

On the A - List:On the A - List:

Hold public meeting on sprout safety and Hold public meeting on sprout safety and initiate rulemakinginitiate rulemaking

Evaluate testing protocol for the recovery of Evaluate testing protocol for the recovery of SalmonellaSalmonella in sprout seeds in sprout seeds

Sprouts are a high risk foodSprouts are a high risk food

A rigorous risk reduction strategy is A rigorous risk reduction strategy is neededneeded

What should the strategy include?What should the strategy include?Who, how, when, where best Who, how, when, where best

applied?applied?

Complexities of issues & Complexities of issues & uncertainty about what current uncertainty about what current

science can supportscience can support

Information on the current scienceInformation on the current science Sources of contamination Sources of contamination InterventionsInterventionsAdequacy of current guidanceAdequacy of current guidance– Expand? Revise?Expand? Revise?

How to better reach seed producers/distributorsHow to better reach seed producers/distributors– Comments by July 18, 2005Comments by July 18, 2005

Documents

Public Meeting: Sprout Safety Michelle A. Smith, Ph.D. Center for Food Safety and Applied Nutrition Food and Drug Administration College Park, MD May 17,