# Presentation: 084484

## 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

**Notes:**
This is an outline of what I plan to cover – it’s a pretty long list for a relatively short period of time.  I will only hit the highlights.  Some of the following presenters will go into more deatil.

## Sprouts - a Special ProblemNACMCF  Produce White Paper 1998

**Notes:**
The National Advisory committee on Microbiological Criteria for Foods has published two white papers that have relevance for this public meeting.  The first paper was Microbial Safety Evaluations and Recommendations for all fresh produce.  In that paper, NACMCF identified sprouts as a special problem.

## 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.

**Notes:**
NACMCF noted a number of opportunities for microbial contamination of fresh produce.  Seed for sprouting and sprouts also have similar opportunities for contamnination.

What makes sprouts special is that the conditions to encourage sprouting also encourage growth of pathogens, if present.

An additional challenge is that treatments that might inactivate pathogens are not useful if they significantly decrease germination of seed, yield, or 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
-   (5)   5					 52
-   (2)   2					 33
- Total: 27 Outbreaks  			1633 cases

**Notes:**
Since 1996, FDA has responded to 27 outbreaks of foodborne illness associated with raw or lightly cooked sprouts.  This slide shows the year, followed by total number of outbreaks associated with sprouts in parenthases, followed by the number of outbreaks associated with different sprout types, alfalfa, clover, and mung bean sprouts.  The last column is the number of reported illness or cases involved in outbreaks.  

I’ve simplified this chart for the purposes of this presentation, and I’ll be coming back to it.

In some cases, math doesn’t quite add up e.g., when the vehicle identified was a mixture of alfalfa and clover sprouts.  We have provided a more detailed list as a handout. 

It’s important to know that Sprouts account for 40 % of all foodborne illness outbreaks associated with fresh produce and about 20 % of all illnesses.

## 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

**Notes:**
Here are a FEW of the milestones in our efforts to minimize foodborne illness associated with sprouts since CDC first brought them to our attention in 1995.  

This is NOT a complete list of the many efforts, individually and in collaboration, to reduce the incidence of foodborne illness associated with sprout consumption, just a few milestones for context.  Some of the collaborations will be addressed by subsequent speakers.

Key items here are the NACMCF sprout white paper and FDA sprout guidance documents

## 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.html
*International Journal of Food Microbiology*, November, 1999

**Notes:**
NACMCF adopted their final sprout white paper “Microbial Safety Evaluations and Recommendations on Sprouted Seed In May of 1999.  The sprout white paper published in the Journal of Food Microbiology and is available at the website noted here.

FDA relied heavily on this paper in developing it’s sprout guidance sprout guidance.

## 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**

**Notes:**
Some of the finding discussed in the white paper include:

## FDA’s Sprout GuidanceOctober 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

**Notes:**
In October, 1999, FDA released final guidance for sprouts; a broad guidance document with key recommendations to minimize food safety hazards for seeds and sprouts; and a companion document to provide additional details on implementing one of the recommendations in the broad guidance, i.e., microbial testing of spent irrigation water.

## 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

**Notes:**
The objectives of the guidance were:

To provide recommendations...

And

To ensure all parties comply with the food safety provisions of the Act.  

While guidance is voluntary, the FD&C act, which requires that food be safe and wholesome, is mandatory.

## 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

**Notes:**
In the FR notice of availablility for the guidance, FDA noted that failure to adopt effective preventive controls can be considered insanitary conditions and that we would consider enforcement actions against anyone who does not have effective preventive controls in place.

Microbial testing is especially important as the final hurdle before product enters the market place.

## 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

**Notes:**
The next two slides show the basic recommendations in FDA’s broad sprout guidance.

First and foremost, EVERYONE has a responsibility.
 Seed should be produced according to GAPs...

## 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* 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

**Notes:**
The broad sprout guide sets out our best ideas of the time for the most important steps to reduce the incidence of foodborne illness associated with sprout consumption.

Except for the companion guidance for microbial testing of spent irrigation water, the FDA guidance does not set out all steps in great detail. 
For additional information, there are references and resources.  There is also an educational video, developed by CDHS and FDA, in cooperation w/ industry and academia that does go into a lot of detail w/ the added advantage of footage shot in actual sprout facilities and attached resources.

## 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

- _[http://www.cfsan.fda.gov/~dms/sprouvid.html](http://www.cfsan.fda.gov/~dms/sprouvid.html)__  or_
- _[http://www.dhs.ca.gov/fdb/PDF/SproutOrderForm4.PDF](http://www.dhs.ca.gov/fdb/PDF/SproutOrderForm4.PDF)_

**“*****Safer Processing of Sprouts*****”**

**Notes:**
The Sprout video is distributed by CDHS-FDB w/ additional information available (in your packets) and through either the FDA or CDHS web sites

## 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.**

**Notes:**
FDA’s first advisory to make consumers aware of the risks associated with eating alfalfa sprouts issued in August, 1998.

In 1999, FDA update the advisory to advise all persons of the risk of eating all raw sprouts.  As with other consumer advisories, we noted the special risk to people in high risk categories and suggested that they not eat sprouts.

What was “new” in this advisory was a statement the (healthy) people wishing to reduce the risk of foodborne illness not eat sprouts.

This might seem like an extreme statement to some but let me put it in context.  

First, the majority of sprout eaters, and those getting sick were not in the at risk groups, they are in the general population.

## 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

**Notes:**
Second, we were in the midst of an very large string of foodborne illness outbreaks associated with sprouts, 6 outbreaks in 1999, mostly clustered in the summer.  It seemed like the outbreaks wouldn’t end.

## 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.....

**Notes:**
In addition to updating the consumer advisory and issuing guidance, we also began an assignment to inspect sprouting facilities (more about that in a little bit)

It seemed like these efforts were paying off.  There were NO outbreaks associated w/ alfalfa sprouts in 2000.

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_
-   (5)   5					 52
-   (2)   2					 33
- Total: 27 Outbreaks  			1633 cases

**Notes:**
A new pattern began to emerge:

FBIO associated w/ S. e. and mung beans

There had been an assumption that bean sprouts were cooked before consumption and that therefore they would not carry the same risk as green sprouts.  However, outbreak investigations were showing food vehicles where bean sprouts were consumed either raw or only lightly cooked, not cooked to the point where pathogens would be eliminated.

In addition, although our guidance and the consumer advisory were meant to address all raw sprouts, some bean sprout producers did not see themselves in the guidance.

## 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](http://www.cfsan.fda.gov/~lrd/tpsprout.html)_

**Notes:**
In 2002, we updated the consumer advisory again to mention bean sprouts by name and to extend our concern to all raw AND lightly cooked sprouts.

## 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

**Notes:**
FDA has issued two field assignments to look at sprouts and sprouting facilities.

The first assignment preceded the NACMCF sprout white paper and our guidance.  At that time, we performed inspections based on the cGMPs in 21 CFR part 110 and administered a questionnaire based on the GMPs.

We also collected samples for microbial analyses throughout production operations from raw, dry seed to finished packaged product.  If sprouts were “washed” after harvest, samples of wash water were also collected.

It’s been a while since this assignment so I don’t plan to dwell on it too much, just make a few points about conditions at that time.

## 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%)

**Notes:**
When FDA does an inspections and sees insanitary conditions or practices, the investigator may issue a 483 “report of observations.  You can think of “insanitary conditions” as practices that are not consistent w/ the Good Manufaturing Practices set out in part 110. 

In 1998, FDA issued a 483 at 47 of the 83 facilities visited or at 57% of the firms.

## 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

**Notes:**
In addition, FDA found samples from three firms were positive for Salmonella.  
The red shows the points in the production process where positive samples were found.  Dashes indicate no samples were taken, possibly because the firm did not was sprouts after harvest.

At firm C samples were positive at seed pre-soak, germinating sprouts, water used to wash sprouts after harvest, and finished product.  Investigators were not able to detect salmonella in the seed at any of these firms using the standard methods of the time.

## 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_

**Notes:**
In 2000, after release of the sprout guidance, FDA issued another assignment. This time the inspection and questionnaire focused more on practices covered in the sprout guidance.  Investigators also collected samples of spent irrgation water at those firms that were themselves doing 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)

**Notes:**
The good news:  No samples were positive for pathogens

The bad news:  FDA 483s were issued at 99 firms
In addition, Warning letters were sent to 65 firms. 
Warning letters were generally issued to firms that met the description “failure to implement effective preventive controls AND had 1 or more observation of insanitary conditions.

For “failure to implement effective controls”, we looked particularly at firms that had not implemented testing programs.  

We did not give the field direct authority to issue a warning letter based on adequacy of seed treatment (or lack of it) because of the complexities of determining, for example, which variations of FDA’s guidance recommendations are adequate and which are not.  

We heard that some folks misinterpreted this to mean that FDA no longer felt seed disinfection treatments were 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%

**Notes:**
A little more good news, there were no significant deficiencies noted at 54 firms.  In addition, firms that had been previously visited, e.g., during the 1998 assignment, were less likely to receive a 483 compared to firms that were being visited for the first time.

When deficiencies were observed, they tended to be in 4 broad categories, namely: personnel cleanliness (including handwashing and the condition of toilet facilities, unsanitary food contact surfaces, evidence of pests, including insects and rodents, and water quality issues, such as an untested well.  

These are the same categories seen in the earlier assignment.

## 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

**Notes:**
Where are we now?

Outbreaks associated with green sprouts appeared to drop off following FDA’s sprout guidance. The average number of cases per outbreak per year appears to have gotten smaller.

However, there were 5 outbreaks associated with alfalfa sprouts in 2003, not a good sign.

## 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?

**Notes:**
Some of the reports from recent outbreak investigations

## 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

**Notes:**
What does FDA have planned for 2005?  
To accomplish some of the activities outlined in the 2004 Produce Safety Action Plan.

## 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