Transcript Document 7505829

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
Outline
Background
– Outbreaks, Collaborative efforts
– Consumer advisories
– Sprout guidance documents
– Observations: field assignments &
investigations
Produce Safety Action Plan
Questions
– Next steps
Sprouts - a Special Problem
NACMCF Produce White Paper 1998
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.
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
2003 (5) 5
52
2004 (2) 2
33
Total: 27 Outbreaks
1633 cases
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
NACMCF
1999 Sprout White Paper
Microbial Safety Evaluations and
Recommendations on Sprouted
Seeds - Adopted May 28, 1999
Basis for FDA’s sprout guide
http:/vm.cfsan.fda.gov/~mow/sprouts2.h
tml
International Journal of Food
Microbiology, November, 1999
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
FDA’s Sprout Guidance
October 25, 1999
1. Reducing Microbial Food Safety
Hazards for Sprouted Seeds
2. 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
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
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
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
Broad Sprout Guide
4.
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 O157:H7
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
“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.h
tml or
http://www.dhs.ca.gov/fdb/PDF/SproutOrd
erForm4.PDF
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.
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
2003 (5) 5
52
2004 (2) 2
33
Total: 27 Outbreaks
1633 cases
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…..
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
2003 (5) 5
52
2004 (2) 2
33
Total: 27 Outbreaks
1633 cases
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
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
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%)
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
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
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)
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%
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
2003 (5) 5
52
2004 (2) 2
33
Total: 27 Outbreaks
1633 cases
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?
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.
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
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%)
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,
seed:solution ratio)
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 O157:H7 but the testing method
varied greatly.
– “unapproved” tests
– Who does tests, where
– Pooling, holding samples
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.
California 2004
Testing 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
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.
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.
Produce Safety From Production to
Consumption: 2004 Action Plan to
Minimize Foodborne Illness
Associated with Fresh Produce
Consumption
October, 2004
http://www.cfsan.fda.gov/~dms/prodpla2.html
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
Sprouts are a high risk food
A rigorous risk reduction strategy is
needed
What should the strategy include?
Who, how, when, where best
applied?
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