Public Meeting: Sprout Safety

1
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, 2005

2
Outline

• Background
• Outbreaks, Collaborative efforts
• Consumer advisories
• Sprout guidance documents
• Observations field assignments investigations
• Produce Safety Action Plan
• Questions
• Next steps

3
Sprouts - a Special ProblemNACMCF Produce White
Paper 1998
4
NACMCF 1998 Produce White Paper

• Fresh produce, including sprouts Opportunities
  for contamination, e.g., production
  (agricultural) environment, subsequent handling,
  storage, distribution marketing
• In addition - Germination conditions foster
  bacterial growth
• Treatments that inactivate pathogens may also
  decrease germination, yield, or affect appearance
  of sprouts.

5
Sprout Outbreaks 1996 - 2004

• Alfalfa Clover Mung Bean Cases
• 1996 (2) 1 1 650
• 1997 (3) 3 1 277
• 1998 (3) 3 1 48
• 1999 (6) 5 2 389
• 2000 (1) - - 1 75
• 2001 (3) 1 2 88
• 2002 (2) 1 1 21
• (5) 5 52
• (2) 2 33
• Total 27 Outbreaks 1633 cases

6
Background A Few Milestones

• Sprouts identified as a problem by CDC in 1995
• Sprout work groups to identify and implement safe
  production practices for seeds and sprouts,
  public mtg, sprout summit.
• 1997 FDA asked NACMCF to study sprouts
• 1999 NACMCF Sprout White Paper
• 1999 FDA Sprout Guidance docs

7
NACMCF 1999 Sprout White Paper

• Microbial Safety Evaluations and Recommendations
  on Sprouted Seeds - Adopted May 28, 1999
• Basis for FDAs sprout guide
• http/vm.cfsan.fda.gov/mow/sprouts2.html
• International Journal of Food Microbiology,
  November, 1999

8
NACMCF Sprout White Paper

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

9
FDAs Sprout GuidanceOctober 25, 1999

• Reducing Microbial Food Safety Hazards for
  Sprouted Seeds
• Sampling and Microbial Testing of Spent
  Irrigation Water During Sprout Production
• http//vm.cfsan.fda.gov/dms/sprougd1.html
• http//vm.cfsan.fda.gov/dms/sprougd2.html

10
Objectives

• Provide recommendations to seed suppliers and
  sprout producers about reducing microbial food
  safety hazards and sprout associated illness, and
• Ensure all parties comply with the food safety
  provisions of the Food, Drug, and Cosmetic Act

11
Federal Register Notice Guidance

• Failure to adopt effective preventive controls
  can be considered insanitary conditions
• - FDA will consider enforcement actions against
  any party who does not have effective preventive
  controls in place, in particular, microbial
  testing

12
Broad Sprout Guide

• Everyone has a responsibility
• 1. Seed production - Good Agricultural Practices
  (GAPs)
• 2. Seed conditioning, storage, and transportation
  - minimize contamination
• 3. Sprout production - Good Manufacturing
  Practices (GMPs) should be standard operating
  procedure

13
Broad Sprout Guide

• Seed treatment - applying one or more approved
  treatments shown to reduce pathogens prior to
  sprouting
• (SUCH AS 20,000 ppm calcium hypochlorite)
• 5. Microbial testing testing spent irrigation
  water from each batch of sprouts for pathogens
  before sprouts enter the food supply
• - Salmonella
• - E. coli O157H7

14
Broad Sprout Guide

• Identifies the most important steps which should
  be implemented immediately to reduce the risk of
  sprouts as a vehicle for illness
• Does not provide detailed information on all
  individual steps that should be followed to
  produce seeds and sprouts
• Resources and references
• CDHS/FDA sprout video

15
Safer Processing of Sprouts

• Educational video produced and distributed by the
  CDHS FDB and the FDA in cooperation with
  industry and academia.
• http//www.cfsan.fda.gov/dms/sprouvid.html or
• http//www.dhs.ca.gov/fdb/PDF/SproutOrderForm4.PDF

16
1999 Consumer Advisory Updated Alfalfa sprout
advisory August 31, 1998

• Advised all persons to be aware of the risks
  associated with eating all raw sprouts.
• People in high risk categories should not eat raw
  sprouts.
• Persons wishing to reduce the risk of foodborne
  illness from sprouts should not eat raw sprouts.

17
Sprout Outbreaks 1996 - 2004

• Alfalfa Clover Mung Bean Cases
• 1996 (2) 1 1 650
• 1997 (3) 3 1 277
• 1998 (3) 3 1 48
• 1999 (6) 5 2 389
• 2000 (1) - - 1 75
• 2001 (3) 1 2 88
• 2002 (2) 1 1 21
• (5) 5 52
• (2) 2 33
• Total 27 Outbreaks 1633 cases

18
Turning the corner w/ sprouts?

• 1999, a tough year
• Updated consumer advisory
• Issuance of direct final sprout guidance
• Initiated directed inspections sprout facilities
• 2000, NO outbreaks associated with alfalfa or
  clover sprouts,
• However..

19
Sprout Outbreaks 1996 - 2004

• Alfalfa Clover Mung Bean Cases
• 1996 (2) 1 1 650
• 1997 (3) 3 1 277
• 1998 (3) 3 1 48
• 1999 (6) 5 2 389
• 2000 (1) - - 1 75
• 2001 (3) 1 2 88
• 2002 (2) 1 1 21
• (5) 5 52
• (2) 2 33
• Total 27 Outbreaks 1633 cases

20
2002 Updated Consumer Advisory

• Advised all persons to be aware of the risks
  associated with eating raw and lightly cooked
  sprouts
• Specifically included mung bean sprouts
• www.cfsan.fda.gov/lrd/tpsprout.html

21
FDA 1998 Field Assignment

• Target 100 firms
• GMP Inspection (21 CFR part 110)
• 83 firms
• Survey Questionnaire
• GMP demographics
• 80 firms
• Samples for microbial analyses
• raw seed ? finished product
• 78 firms

22
FDA 1998 Inspection Results

• FDA-483 Report of Observations, issued when
  insanitary practices or conditions are observed
• 83 Facilities Inspected
• FDA-483 Issued at 47 firms (57)

23
FDA 1998 Microbial Analyses

• Firm Stage of growth
• A RAW PRE GERM ----- FIN
• B RAW PRE GERM ----- FIN
• C RAW PRE GERM WW FIN
• () Salmonella sp., alfalfa

24
2000 Field Assignment

• Target 150 firms
• Limited Inspections (focus on practices in
  guidance)
• Questionnaire re recommendations in guidance
• Collect and test spent irrigation water from
  firms that are testing

25
2000 Inspection Results

• 137 firms inspected
• Good news No positive water samples
• Bad news
• - FDA-483 to 99 firms (72)
• - Warning letters 65 firms (47)
• Unsanitary conditions
• Failure to implement effective controls, emphasis
  on microbial testing
• (Seed treatment still important)

26
2000 Directed Inspections

• No significant deficiencies 54 firms (39)
• Firms inspected in 1998 did better than firms not
  previously visited
• Deficiencies
• Personnel cleanliness 20
• Unsanitary food contact surfaces 24
• Pests 28
• Water quality 28

27
Sprout Outbreaks 1996 - 2004

• Alfalfa Clover Mung Bean Cases
• 1996 (2) 1 1 650
• 1997 (3) 3 1 277
• 1998 (3) 3 1 48
• 1999 (6) 5 2 389
• 2000 (1) - - 1 75
• 2001 (3) 1 2 (32) 88
• 2002 (2) 1 1 (5) 21
• (5) 5 52
• (2) 2 33
• Total 27 Outbreaks 1633 cases

28
Adequacy of Current Guidance

• Some inspectors recent outbreak investigations
  reported sprouter appears to be following FDA
  sprout guidance.
• Questions
• Consistent and Appropriate application of
  recommended practices?
• Adequacy of current guidance?

29
California Sprout Industry Inspection February
2004

• CDHS FDB and FDA inspectors visited every
  registered sprout grower in California
• A standardized questionnaire was used to evaluate
  if practices consistent with current GAPs and
  GMPs guidance.

30
California 2004 - Inspection Checklist

• Seed Storage
• Pest control
• Sprout Production
• Seed Treatment
• Testing for Pathogens
• Storage and Distribution of Sprouts
• Traceback Capability
• Cleaning and Disinfection

31
California 2004 - Sanitation

• 50 of firms were described as having
  deficiencies including
• unsanitary food contact surfaces (38)
• evidence of pests (33)
• lack of personnel cleanliness (25)
• water quality problems (8)

32
California 2004 - Seed Treatment

• 70 of sprouts were treated with Ca(OCl)2
• Sodium hypochlorite (25), ozone, and
  peroxyacetic acid were also used.
• only 2 used the correct concentration,
  duration, and method (e.g., agitation,
  seedsolution ratio)

33
California 2004 - Sampling and Microbial Testing
of Spent Irrigation Water

• 71 of firms collected spent irrigation water for
  microbial testing
• Almost all firms tested for Salmonella spp. and
  E. coli O157H7 but the testing method varied
  greatly.
• unapproved tests
• Who does tests, where
• Pooling, holding samples

34
CA 2004 - Confirmatory Tests

• 11/17 (65) conduct confirmatory testing
  following an initial positive test result
• 4/17 (24) have never had an initial positive but
  would conduct confirmatory testing if necessary
• 5/8 (63) use spent irrigation water while 3/8
  (38) use enrichment media for conf. testing
• Almost half wait to ship until the results have
  been received.

35
California 2004Testing Spent Irrigation Water

• Record Keeping
• 15/17 (88) that conduct testing maintain records
  of test results from 48 hour spent irrigation
  water samples.
• 1/17 (6) maintains a record of 48 hour spent
  irrigation water samples collected but not the
  results.
• Data missing from 1 firm

36
California 2004 Record Keeping

• Less than 20 that conduct confirmatory testing
  maintain records of the positive results.
• A majority of firms (92) do not maintain records
  of the disposition of the product where
  irrigation water is confirmed positive.

37
CA 2004 - Traceback Capability

• 17/24 (71) of firms reported having the ability
  to trace sprouts back to their source seed
  supplier.
• Maximum number of seed lots used to produce one
  finished product lot ranged from 1-10.
• 12/24 (50) of firms identify finished product
  with a lot number or date designation.

38
Produce Safety From Production to Consumption
2004 Action Plan to Minimize Foodborne Illness
Associated with Fresh Produce ConsumptionOctober,
2004http//www.cfsan.fda.gov/dms/prodpla2.html
39
2005 CFSAN Program Priorities

• On the A - List
• Hold public meeting on sprout safety and initiate
  rulemaking
• Evaluate testing protocol for the recovery of
  Salmonella in sprout seeds

40
Sprouts are a high risk foodA rigorous risk
reduction strategy is neededWhat should the
strategy include?Who, how, when, where best
applied?
41
Complexities of issues uncertainty about what
current science can support

• Information on the current science
• Sources of contamination
• Interventions
• Adequacy of current guidance
• Expand? Revise?
• How to better reach seed producers/distributors
• Comments by July 18, 2005