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May 17, 2005
Aside from minor spelling and style corrections, the wording of this document is exactly as received from the commercial transcribing service. Accordingly, FDA makes no representation as to its accuracy.
Robert Brackett, Ph.D.
Nega Beru, Ph.D.
Foodborne Illness Outbreaks
--Amy Dechet, M.D., Epidemic Intelligence Officer, Foodborne and Diarrheal Diseases Branch, Centers for Disease Control (CDC)
Sprout Guidance, Background and Next Steps
--Michelle Smith, Ph.D., Interdisciplinary Scientist, Office of Plant and Dairy Foods, CFSAN, FDA
Questions and Answers
State of the Sprout Industry
--Bob Sanderson, International Sprout Growers Association (ISGA)
Seed Handling and Distribution Systems
--Bob Rust, International Specialty Supply
--Caroline Smith DeWaal, Center for Science in the Public Interest
Questions and Answers
Microbiological Findings on Sprout Operations Following FDA Guidance
--Jed Fahey, D.Sc., Johns Hopkins School of Medicine
Interventions
--William Fett, Ph.D., Eastern Regional Research Center (ERRC), ARS, USDA
--Kathleen Rajkowski, Ph.D., Eastern Regional Research Center (ERRC), ARS, USDA
Testing Methodologies and Sampling
--Mary Lou Tortorello, Ph.D., Research Microbiologist, Office of Plant and Dairy Food, CFSAN, FDA
--Tong-Jen Fu, Ph.D., Research Chemical Engineering, Office of Plant and Dairy Foods, CFSAN, FDA
Alternative Seed Sanitation Methods and the Results of Practical Field Applications
--Kean Ashurst, Caudill Seed Company
Risk Analysis
--Don Schaffner, Ph.D., Rutgers
Questions and Answers
Public Comments
Nega Beru, Ph.D.
DR. BERU: Good morning, everyone. I guess we'll get started. We said the program would start at 8:30. We gave a little time for some of the stragglers, traffic and so on but good morning and I would like to welcome you to this public meeting on sprouts.
My name is Nega Beru and I'm the Associate Director of the Office of Plant and Dairy Foods in CFSAN. I also am the moderator for this meeting.
As you know, this meeting is intended to elicit information on the current science related to foodborne illness associated with the consumption of sprouts.
Before I introduce the agenda and the panelists for our meeting, I would like to invite Dr. Robert Brackett, Director of the Center for Food Safety and Applied Nutrition, to make his opening remarks.
DR. BRACKETT: Thank you, Nega.
Good morning to all of you and welcome to this public meeting on sprout safety. It really is a pleasure to be with you here today and I had hoped to be here the entire day with you but I had a hearing that was changed to today so I will stay for a little while and head downtown right away again.
Microbial food safety of fresh produce is a priority for CFSAN and so is the role of fresh produce and a healthy diet, which is also important to us.
In October of 2004, CFSAN finalized an action plan for fresh produce. This meeting continues our dialog with stakeholders on how to ensure that foodborne illnesses associated with fresh produce, and that includes sprouts, is minimized to the greatest extent possible.
During the past decade, over 20 percent of all produce related foodborne illnesses were associated with the consumption of raw or lightly cooked sprouts. CDC first brought sprouts to our attention as a vehicle for foodborne illness back in 1995. In a 1998 white paper on fresh produce, the National Advisory Committee on Microbiological Criteria for Foods identified raw sprouts as a special food safety problem. In 1999, the National Advisory Committee on Microbiological Criteria for Foods issued a report entitled "Microbiological Safety Evaluations and Recommendations on Sprouted Seeds." Since then, FDA has issued several consumer advisory warnings about health risks associated with the consumption of raw sprouts. FDA also released two guidance documents, one on seed disinfection and the other on testing irrigation water, concerning practices to minimize microbial contamination of sprouts. We have worked collaboratively with other agencies, groups, and the industry in a variety of different ways. Although the guidance documents were well received, and their reissuance and adoption appears to have resulted in some improvement, outbreaks implicating sprouts continue to occur.
As a way to address the public health risk associated with the consumption of raw and lightly cooked sprouts, FDA is considering the development of a regulation. The purpose of this meeting is to elicit information on the state of the science with respect to sprout safety and intervention strategies and also to engage you, the stakeholders, early on in the rulemaking process.
We believe that the most effective strategy for reducing foodborne illness from raw and lightly cooked sprouts is likely to be one that approaches the problem from several different angles. For example, we need to look at the seed producers and distributors as well as the sprout producers to understand the practices that contribute to the contamination of sprouts with human pathogens. It's important that we consider the views and ideas of all of our food-safety partners. By working together, we think we can achieve this goal. Consequently, I am looking forward to hearing your views and seeing them later on, and your comments, and I hope that you find that the discussion is worth your while as well.
So with that I would like to again welcome you to CFSAN and wish that I could stay for the whole day. Thanks.
DR. BERU: Thank you, Bob.
As you will note from the agenda you picked up on your way in, we have a pretty fully day but before I go over the agenda with you let me just say a few words about housekeeping.
The all important rest rooms--this is a full day meeting so I should point that out first--are upstairs where you registered as you came in that hallway. There are also rest rooms down the hall out this door.
We will provide refreshments during the breaks but you are on your own for lunch. There is the Wiley Cafe, which you probably saw as you walked into the building. And if you drove, there are a number of places to eat up and down Route 1, as well as on Kenilworth Avenue.
We have a number of people who have registered to provide comments at the end of the formal presentations during the comment portion of this meeting. If you have not registered but still wish to make a comment, please see me some time during the meeting and we'll add you to the list.
And when you ask questions or make comments, please wait to get the microphones or step to one of the two microphones on the sides of the auditorium. We are making a transcript of the meeting and we want to be sure we capture everything, including your name and affiliation. The transcript is going to be made available on our website in about four weeks time.
Now let me go over the agenda. It is in your packets if you want to follow along. We've had the opening remarks by Bob Brackett, our Center Director.
We'll first have a session which we've termed "Government Perspective". Dr. Amy Dechet from the CDC, who is an Epidemic Intelligence Service Officer in the Foodborne and Diarrheal Diseases Branch of the CDC, will first present on foodborne illness outbreaks.
That will be followed by Dr. Michelle Smith, Interdisciplinary Scientist in the Office of Plant and Dairy Foods, CFSAN. Dr. Smith will present on the sprout guidance, background and next steps.
I'll ask you to hold questions until both speakers have gone through their presentations and they will come to the front and then we'll have a question and answer session.
We'll take a break at that point and we'll go into what we term the "Industry and Consumer Perspectives." First we'll have a presentation by Mr. Bob Sanderson, International Sprout Growers Association, on the state of the sprout industry.
And then Mr. Bob Rust from the International Specialty Supply will present on seed handling and distribution systems.
And we'll have a consumer perspective by Ms. Caroline Smith DeWaal from the Center for Science in the Public Interest.
When all three have done their presentations, again we'll have a question and answer session of those three panelists.
Then we'll go into what we call the "Scientific Perspective" section of the meeting. First microbiological findings on sprout operations following FDA guidance by Dr. Jed Fahey from Johns Hopkins School of Medicine.
And we'll take a few questions but we'll hold most of the questions for Dr. Fahey until after the other scientific presentations have--we've gone through the other presentations. We'll have lunch at that point. As I say, lunch is on your own.
And then after lunch the first presentation will be by Dr. William Fett, Eastern Regional Research Center, on interventions, and Dr. Kathleen Rajkowski, Eastern Regional Research Center again from USDA, ARS.
That will be followed by "Testing Methodologies and Sampling" by two of our own scientists at the Moffitt Center, Office of Plant and Dairy Foods, CFSAN. Dr. Mary Lou Tortorello, who is a research microbiologist at the Moffitt Center and Dr. T-J Fu, who is a research chemical engineer, also of the Moffitt Center.
That will be followed by "Alternative Seed Sanitation Methods and the Results of Practical Field Applications" by Kean Ashurst--I hope I'm saying that--pronouncing the name correctly--Caudill Seed Company.
And the last of the scientific presentations will be one on "Risk Analysis" by Dr. Don Schaffner from Rutgers.
There will be a question and answer session again of the scientific perspective presentations. We will take a break and we'll go into the public comment section of the meeting. And then I will summarize the meeting and we will end that.
With that, I would like to invite Dr. Amy Dechet from the CDC to present on "Foodborne Illness Outbreaks".
As I said, please hold until both Drs. Dechet and Smith have made their presentations.
[See presentation slides for Dr. Dechet]
DR. DECHET: Good morning and thank you for the opportunity to speak with you today.
I thought to begin this meeting it would be helpful to give you an overview of some of the characteristics of sprouts and their outbreaks, and put it in the context of the produce-associated outbreaks as well as foodborne outbreaks in general.
Each year in the United States we estimate that there are over 76 million foodborne illnesses, over 300,000 hospitalizations and over 5,000 deaths. Now these numbers sound large and they are large but what does this really mean?
This means that one in four Americans will become ill. So if you look in the room around you and look at three other people, one of you is probably going to become ill from some sort of foodborne illness this year. One in 1,000 Americans are expected to be hospitalized and this will result in over $6.5 billion in medical and other costs such as time lost from work.
The Centers for Disease Control and Prevention and, in particular, the Foodborne and Diarrheal Diseases Branch, where I work, maintains a Foodborne Outbreak Surveillance System. The Local and state health departments are a primary contributor to this system as they are the ones responsible for detecting, investigating and controlling outbreaks. At CDC we will participate in these investigations when we are specifically requested by the states to do so and we do some field investigations every year with states and provide over 100 phone consultations as well.
Once information is gathered from the states it's usually sent to the CDC where we collect data on the number of cases, the implicated food and the etiology. To be entered into the system, we define an outbreak as two or more cases of a similar illness resulting from the ingestion of a common food.
I want to point out that this system is completely voluntary. States are not required to report, although most do participate and some of the data we get is incomplete. It could be because at the state level they were unable to get the information or it simply did not make it on to the form. I'll also point out that some of the information that we have may not match exactly the same numbers that FDA has and this is because again our systems are slightly different.
If you look at now at our Foodborne Outbreak Surveillance System over the past decade or so, you'll see on the X axis the year and on the Y axis the number of outbreaks per year. You notice that in 1998 there is a significant jump in the number of outbreaks. This is probably an artificial increase because we actually enhanced surveillance quite a bit during that year and, as you can see, since that time we've averaged around 13 to 1,400 outbreaks per year.
Looking specifically at produce associated outbreaks from 1998 to 2002 where we have the most complete data, we know of 249 outbreaks, and this represents six percent of outbreaks with a reported food source and 13 percent of outbreak associated cases.
If then we turn to the implicated produce, many of these produce outbreaks are sort of a generic or multiple produce item outbreak where people mention salad or salad was the implicated item but then we also do have some information on produce specific outbreaks. And as you can see the top six there are highlighted in yellow, which includes lettuce, sprouts, juice, melon, tomato and berries.
Taking those same top six now I've again listed here the number of outbreaks. Again this is up to 2002. And then the percent of population eating that food in the week prior to interview. And this is based on our FoodNet population survey where people are randomly called and asked, "Did you eat this food item in the seven days prior to interview on the phone?" And as you can see lettuce, which is the top of our list of outbreaks, over 70 percent of people reported eating lettuce in the week prior to interview. The rest of them, excluding sprouts, range anywhere from 21 to 68 percent but, if you look at sprouts, only eight percent of people recall eating sprouts in the week prior to the interview on the phone and yet it's the second leading cause of produce associated outbreaks.
Now we fondly refer to sprouts as our stealth vehicle in foodborne outbreaks because many people don't realize they're eating sprouts. They're often in salads or in sandwiches and people don't remember that they ate sprouts. In fact, in many of the outbreak investigations only 30-40 percent of people will outwardly recall eating sprouts but then when we look at other implicated food items and break it down by ingredients we often do find sprouts then in those food items.
So what is it about sprouts that makes them so unique? Many of you, I think, probably already know this information. I'll just briefly review it. There are, of course, multiple opportunities for contamination along the spectrum from the farm to the table. At the field level there are birds flying overhead, there are animals passing through, and even if animals are grazed on the field months beforehand we have some evidence to show that actually the seeds can be contaminated when they are grown months later.
During the harvesting process sometimes a few combines are used for many different fields and they are also processed in one large central processing facility and so, therefore, if you have a contaminated batch it can actually then mix with other batches and contaminate a larger amount of sprouts or seeds.
During the scarification process where the seeds are rubbed between hard surfaces in order to crack the seed it's a perfect time for bacteria to enter into that seed and then sit there and actually they can survive there for a several months period of time.
Then, finally, there's multiple times where during transport it could become contaminated. From the field to the processing facility to distribution by the sprouters to the grocery stores and back home. So you've got many people handling the sprouts and again bacteria can amplify throughout the process.
And then, of course, there's the sprouting process as well. This is a lovely microbiological environment for bacteria to grow. It's warm. It's moist and, depending on the literature that you read, anywhere from a two to four log increase in colony forming units per gram can occur.
Unfortunately, it's difficult to detect pathogens. The contamination is usually non-homogenous so if you sample one part of the seed or the sprout you may not actually be getting a representative sample of levels of contamination elsewhere. Also, there can be low levels of contamination which are difficult to pick up on culture methods.
Finally, sprouts are rarely cooked or washed by the consumer and this is often our final safety net for many food items that at least you can hope that the consumer will cook things well and that will kill a lot of the bacteria but this usually does not occur with sprouts.
There are a couple of other things that make sprouts unique. Sprouts is very democratic. It likes all sorts of different organisms. We have many different serotypes of Salmonella that have been implicated in sprout outbreaks as well as E. coli . We have some of the serotypes a little bit unusual here in the United States such as bovismorbificans, mbandaka and we also have the E. coli 0157:non-motile. These organisms are more common in animals overseas and again sort of suggests that there may be some connection with the field and contamination at the seed level.
There also are multiple kinds of sprouts as you very well know. I have just listed a few of them here. While they have similar characteristics, they may not all actually be identical in terms of their likelihood of transmitting pathogens the way in which they're eaten.
And then, finally, as I've alluded to already, sprouts--we have international partners with sprouts in the seeds and the whole process, and while it's challenging enough to control what happens here in the United States, it's even more challenging to control things overseas and on the individual farms.
So I'd like now to turn to sprout outbreaks by year and I've done this in a graphical form. We have on the X axis again the year and on the Y axis the number of outbreaks. The peach colored color is the alfalfa. The dark grey the mung bean, the orange clover and then green is mixed, and that generally is clover and alfalfa combined. As you can see, when we first learned about sprout associated outbreaks in 1995 with Salmonella , we had a pretty strong increase up to 1999 which then decreased and again rose in 2003.
I'm going to take away all but alfalfa simply to clarify a point here. We know that alfalfa outbreaks through 2004--actually to the current day as far as we're aware from 1995 is 26 outbreaks. As you can see there was--and I think it was mentioned this morning--there was growing concern about the cause of alfalfa sprouts and other sprouts leading to foodborne illness. So there was an interim advisory and then guidelines passed in 1998 and '99 by the FDA to advise chlorination of the seed with 20,000 parts per million and then also testing of the irrigation wash water, which I think we'll hear a little bit more about in the next talk.
This looked very hopeful because in 2000, 2001 and 2002 the numbers of outbreaks decreased but then we had this explosion of outbreaks in 2003 and this raised concern about what might be happening in the industry.
The next logical question is, well, perhaps why we have all these outbreaks is that people weren't following the guidelines and that certainly is a very reasonable question to ask. We do have some information on who was following the FDA guidelines. The ones in peach here we don't know whether they were or not. The orange, we have evidence to suggest that they complied with the guidelines. And the green suggest they did not comply. As you can see, we have both orange and green after the guidelines were passed. So again what this represents is that perhaps the current practices--current regulations are not sufficient enough to prevent outbreaks.
I'd like to turn from that time period of 1998 onwards and just look at the average size of outbreaks by year. I have again listed the number of outbreaks, the total number of cases that we're aware of as reported by the states, and then the mean number of cases per outbreak.
As you can see, particularly looking at the year 1999 and then looking towards the later years, 2003-2004, it suggests that perhaps the outbreaks are getting smaller and this could be a very positive thing and could be a result of the guidelines being followed by the sprouters. I caution, though, in too much interpretation of this data because we are every year getting better at detecting outbreaks. We now have a good system of DNA fingerprinting across the nation and actually even internationally. So I think we are picking up outbreaks quicker before they become larger. We sometimes are picking up outbreaks of two to three people because states--they have a lot of people working in the state to follow through on outbreaks to look at some of the DNA fingerprinting measures and we're doing more and more biological testing.
Of course, a remaining question and one I'll end with is, well, perhaps outbreaks are not the best way to measure the effectiveness of an intervention. I want to just return very quickly to a different produce item, to juice, number three on our list that I showed earlier.
Here we have the number of juice outbreaks from 1995 to 2005 similar to what I've shown you with sprouts. Each box represents an outbreak and the various colors are suggestive of different kinds of juice. Around the same time period there was a juice labeling regulation that was passed in 1998-99. As you can see, it certainly rose in '99 and then actually has decreased and remained low. There have been various HACCP regulations throughout.
The last four in red there from 2002 to 2005 actually represent outbreaks that would not have been included in the HACCP regulations due to specific quality and size, for instance, of the juice facility. So this graph suggests that actually you can use outbreaks to show that an intervention is effective or perhaps that it's not as maybe is suggested by the sprout outbreaks.
So to summarize and conclude, sprout associated outbreaks represent a small proportion of the foodborne outbreaks in general but they are one of the most common vehicles identified in produce associated outbreaks and this is particularly in the setting of a produce that actually is not eaten as much as other produce items in those top six items.
I think we're seeing actually with the organic movement as well as the sort of health related movements that more and more people are eating sprouts and again the numbers I suggested maybe perhaps are not totally accurate because probably more people are eating sprouts and aren't even aware.
As suggested by the number of outbreaks most recently, the current practices and regulations are not adequate to prevent disease from sprouts and I think that is why we're all here and looking forward to a good discussion throughout the day.
Finally, outbreak surveillance does offer opportunities for tracking effectiveness of interventions and we certainly at CDC will continue to collaborate with all parties involved to try to prevent disease in humans from sprouts.
Thank you very much.
DR. BERU: Thank you, Dr. Dechet.
Our next presenter will be Dr. Michelle Smith, Interdisciplinary Scientist in the Office of Plant and Dairy Foods.
By the way, we will have bios copy made available either during the break or during the lunch break.
Dr. Smith will present on "Sprout Guidance Background and Next Steps."
[See presentation slides for Dr. Smith]
DR. SMITH: It's a pleasure to be here this morning and I'd like to thank everyone in the room for coming also and I'm looking forward to what comes out of this program and, hopefully, we can make some good progress together.
This is an outline of some of the things that I intend to cover in my presentation. I don't have a lot of time because mostly we want to hear from you but I would like to talk a little bit more about outbreaks, collaborative efforts, consumer advisories and some of the things that have happened since we started working together on sprouts just as food for thought as this effort goes forward.
Dr. Brackett mentioned the Produce Safety Action Plan. I'll do that also. And Dr. Dechet brought up some of the questions surrounding the adequacy of FDA's guidance and I'll talk a little bit about them along with next steps. Where do we go from here and how do we get there?
As has been mentioned, sprouts were first described as a special problem in the NACMCF Produce White Paper that became available in 1998. NACMCF in that paper talked about opportunities for contamination for fresh produce items, including sprouts, and some of these opportunities have been covered. What makes sprouts special, as everybody here probably knows, is that the conditions that foster the germination of the sprouts also promote the growth of pathogens if they're present.
An additional challenge for this group and for anyone involved in coming up with interventions is that many of the treatments that have been looked at to inactivate pathogens may also decrease germination of the seed, decrease yield or affect the appearance of sprouts. And treatments that result in any of these make that treatment option much less viable.
Now this is my simplified chart for purposes of this meeting of outbreaks. Our numbers are just a little bit different from CDC numbers. According to my total, we have been involved in 27 sprout associated outbreaks since 1996. The first column is the year, the second column is the total number of sprout associated outbreaks in parentheses, followed by columns of different sprout types and how that particular outbreak was attributed to a certain type of sprouts. In a few cases the numbers don't quite add up. Some of that may be due to the fact that it was a mix of sprout types and numbers have fallen in more than one column. For example, in both alfalfa and clover because we weren't able to tease it out. Then finally the last column is the number of reported cases of illness associated with the outbreak and the actual number of illnesses is very likely much larger than the number of illnesses reported.
Now just a few milestones to put some context around the different activities. CDC brought sprouts to our attention in 1995. The second bullet could run two pages. There have been many, many, many work groups, collaborative efforts, other projects started individually and by agencies and industry in cooperation to try and address the issue of sprout safety. This is a very complex issue and we're still working on it and that's why we're here today.
FDA asked NACMCF to look at sprouts in 1997 and they published the Sprout White Paper in 1999. This paper played a very large role in the guidance that FDA released later in that year.
If you haven't seen the Sprout White Paper there is still a lot of very good information in that paper looking from soup to nuts at sprouts. It's available at this website and also published in the International Journal of Food Microbiology.
Some of the findings in the Sprout White Paper, and it was an extensive paper but some of the findings I'd like to highlight here are that seeds are the most likely source of microbial contamination. Things can get worse in the sprouting facility if appropriate practices are not followed but most, if not all, outbreaks it appears that the seed brought the contamination in, in the first place. If the seed is damaged or scarified that can increase the chances of pathogens becoming internalized in the seed and it also makes it much more difficult for any kind of treatment to disinfect the seed prior to sprouting.
The NACMCF Sprout White Paper specifically recommended a five log seed disinfection treatment to be applied before the initiation of sprouting. This five log standard was not formally included in FDA's guidance, and I'll get to what we said in a couple of minutes but it has been very widely used as the target by many of the people looking at interventions and comparing different interventions.
We made available two guidance documents in October of 1999. The first guidance "Reducing Microbial Food Safety Hazards for Sprouted Seeds" is a very simple, broad guidance document containing five steps that we feel are important to minimizing food safety hazards for sprouted seed. The second guidance document "Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production" provides additional guidance on how to implement one of the first five recommendations. Specifically, the microbial testing of spent irrigation water. The testing process is very complex and scientific, and I brought in our microbiologist to write that. I wasn't able to write it and if I tried to rewrite it I would have to share it with them to make sure I got it right but this issue warranted its own guidance document just to help people understand the procedures for the microbiological testing. Both of these documents are available on our website which is noted there.
The objectives of the guidance were to provide recommendations to seed suppliers and sprout producers about reducing microbial food safety hazards and sprout associated illnesses and to ensure that all parties comply with the food safety provisions of the Food, Drug and Cosmetic Act.
Our guidance documents are guidance. The specific recommendations that we feel are important for microbial food safety for sprouts are just that. They are recommendations. They are guidance. The individual recommendations are not requirements. At the same time the Food, Drug and Cosmetic Act requires that food be safe and wholesome and not produced or held under insanitary conditions. That act contains requirements for all foods.
In the Federal Register notice announcing availability of the guidance there were several statements, including "failure to adopt effective preventive controls can be considered insanitary conditions." And a notice that FDA will consider enforcement actions against any party who does not have effective preventive controls in place. And we put particular emphasis on microbial testing because that's the last hurdle before the product is released into the marketplace and gets to the consumer.
Now in the broad sprout guide there are five points. Everyone has a responsibility for this guidance to be effective or as effective as it can be. Everyone along the way needs to contribute to improving and maintaining the food safety of that component over which they have control and it starts with seed production. We recommended good agricultural practices for the production environment for the seed, that seed be conditioned, stored and transported under conditions that would minimize opportunities for contamination. When you get into the sprouting facility we are recommending that producers follow good manufacturing practices which are set out in 21 CFR Code of Federal Regulations Part 110 that these GMPs should be standard operating procedure.
Also, we recommend seed treatment. This is the FDA language and our guidance. We recommend applying one or more approved treatments shown to reduce pathogens prior to sprouting. And as an example we give the 20,000 parts per million calcium hypochlorite. This does not say that the seed treatment has to be 20,000 parts per million calcium hypochlorite and when we drafted the guidance back in 1999 we were very hopeful that treatment alternatives would be discovered and available because we know there are downsides to this particular treatment but it at least up until now has remained pretty much the gold standard. The one that people are most familiar with and the most data exists for.
And then finally because there is no single treatment that we're aware of that can be counted on to completely eliminate pathogens on seed, we recommended microbial testing of the spent irrigation water, the water that flows through the sprouts during the production practice and we recommended that this testing be done on each batch of sprouts before the sprouts enter the food supply. Salmonella and E. coli O157:H7 are the pathogens of primary concern in sprouts and these are the pathogens that we recommend testing for.
Now any guidance, including the sprout guidance, identifies the most important steps that we were able to identify at the time the guidance was released to improve food safety and in this case we believe that those recommendations should be implemented immediately to reduce the risk of sprouts as a vehicle for foodborne illness.
The broad sprout guide did not provide detailed information on all individual steps that should be followed to produce seeds and sprouts. The broad sprout guide just set out the five items. The idea was to have a simple document that could be pasted to the wall. It was the microbial testing where we specifically went into details on how to. However, both documents contain additional resources and references and we have done additional things since the guidance to provide more information.
One of the things that was put together was an educational video "Safer Processing of Sprouts." This was a joint California Department of Health Services-FDA video produced in cooperation with industry and universities. It was a fairly large workgroup that got together and came up with the script. Many sprouting facilities volunteered their facilities to be filmed as part of this video.
One of the things I think that is particularly good about this video is that these are actual sprout production facilities and if you look at the video and you listen to what it has to say it puts a sprout face on many of the very basic issues like worker health and hygiene and good manufacturing practices. More information about the video is available both on the California website and on FDA CFSAN's website.
There has been mention of the consumer advisories that FDA has put out. Our first advisory issued August 31st, 1998, and that advisory focused on alfalfa sprouts. When sprouts first came to our attention alfalfa was the one that we knew about and so that was the subject of the advisory.
In 1999, we updated this advisory to cover all raw sprouts because we were beginning to get more evidence that at least some of the outbreaks were not just alfalfa sprouts but maybe alfalfa, clover mixtures, and at least one, we think, the clover seed was the source.
The 1999 consumer advisory advised all persons to be aware of the risks associated with eating all raw sprouts. We noted, as we do often in consumer advisories, that people in high risk categories should not eat sprouts, should not eat raw sprouts, and there was a new kind of statement in this advisory. Persons wishing to reduce the risk of foodborne illness from sprouts should not eat raw sprouts.
There were several driving forces behind including a statement this strong in the advisory. One of the driving forces was that the majority of people experiencing foodborne illness associated with sprouts were not in the high risk categories. They were just normal healthy large population people. The other driving force you can see in this slide in the red numbers. In 1999, mostly clustered in the summer time, there were six outbreaks associated with sprouts. That summer it felt like sprout outbreaks would never end and I don't think anybody here wants to go back to that summer again.
Before we released the advisory we did call in some members of industry and share it with them and discussed the situation but it was decided that that's the wording that we would go with.
So 1999 was a tough year with the updated consumer advisory, the six outbreaks. We issued our sprout guidance as a direct final. Usually we go through two stages, proposed first, ask for comments, and then go to final incorporating those comments. Because of the large number of outbreaks we went straight to final guidance but we did offer an opportunity for comment on that guidance and we've collected those comments and considered them.
We also initiated an assignment to inspect sprout facilities and I'll get into that in a little bit.
Now this was a lot of activity. It wasn't all pleasant but in 2000 there were no outbreaks associated with alfalfa or clover sprouts so as painful as this might have been it looked like we were having a positive effect.
There was one problem. As the alfalfa and clover situation appeared to be getting better, a new trend started to emerge and that was outbreaks involving mung bean sprouts and Salmonella enteritidis. A couple of things about mung bean sprout outbreaks. Even though our '99 advisory was meant to cover all raw sprouts, we were hearing from some people that maybe mung bean sprout producers did not see themselves in that guidance. There are differences in the production practices. You might look at an alfalfa seed compared to a mung bean seed and notice that the alfalfa seed has a much rougher surface and mung bean is very smooth. There is less opportunity for pathogen attachment, et cetera. There are still natural structures on mung bean seeds that pathogens could very easily attach to so there may have been somewhat of a false sense of security.
There also was a general assumption at least on our part that mung bean sprouts were cooked before consumption so it would have a lower risk associated with them. When we started investigating the outbreaks associated with mung bean seeds and identified the food vehicles involved, we saw that those food items contained as an ingredient either raw mung bean sprouts or mung bean sprouts that had only been very lightly cooked. Not cooked long enough or at a higher enough temperature to eliminate any pathogens that might have been present. So the assumption that mung beans were cooked to the point where microbial food safety wouldn't be a concern didn't necessarily hold true.
So in 2002 we took our previous advisory and we updated it again to advise all persons to be aware of the risks associated with eating raw and lightly cooked sprouts, and we specifically included mung bean sprouts by name so that there could no longer be any confusion or misconception about whether or not bean sprouts were included in our concerns.
I mentioned that we've done a couple of field assignments. The first one was in 1998. This preceded the NACMCF recommendations and it preceded FDA's guidance. So what we looked for in 1998 wasn't based on the guidance itself. We looked at facilities in terms of the current good manufacturing practice regulations in Part 110. We targeted 100 firms. We usually draft an assignment with a goal in mind. We ended up doing inspections at 83 firms. There was a very long questionnaire. Again largely based on the GMPs and also to gather demographic information, information about the size of facilities, products produced, number of employees, things like that. Eighty firms that were visited answered questions on this survey.
Finally, we collected samples for microbial analysis. Samples were collected at different points in the production process starting with raw, dry seed and going all the way to finished product. Samples were tested for the pathogens, Salmonella , E. coli 0167:H7 and a number of other non-pathogenic microorganisms were enumerated. Samples were collected at 78 firms.
Now this is just for context. I'm not going to dwell a lot on the specifics back in '98 because it's not 1998 anymore and I think things have changed but at that point in time out of the 83 facilities that were inspected 47 of the firms or a little bit more than half of the firms received what is called an FDA 483. This is a report of observations that's usually issued when insanitary practices or conditions are observed. And in some of the more recent assignments I'll give some examples of the things that we see as insanitary practices or conditions.
In the microbial analysis we found positives for Salmonella at three firms visited. At firm C the samples were positive in the pre-sprouted or pre-soaked seed but prior to sprouting. Midway between the sprouting process samples were collected and they were positive. When firms washed sprouts after harvest, wash water was collected and this was the case in the third firm. That was also positive. And finished product was positive at all three firms.
In no instance in this assignment were any of the samples of raw seeds that were collected found to be positive for pathogens and this may indicate at least using the methodology of the time some of the difficulties with microbial testing of seed.
We did a follow-up assignment in 2000. This time we targeted 150 firms, did a more limited inspection focusing on the recommendations and FDA's guidance, and also used a much shorter questionnaire. Again looking at the recommendations in FDA's guidance and trying to get more detail. First of all, were they being applied and, if so, how were they being applied? We collected and tested spent irrigation water from firms that reported that they were doing testing themselves.
The good news is that we did not find any samples to be positive for pathogens in the 2000 assignment. The bad news is that FDA 483s or notice of observations were issued to 99 firms or 72 percent. None of these assignments were designed in a way where you can do any kind of quantitative comparison between the numbers. To a large extent the individual investigators may be very subjective in what they decide is an insanitary condition and whether or not they issue a 483 but there is some qualitative information that can be gained from this, particularly with respect to the kinds of observations that were made.
Another thing that we did in 2000 was we issued a fairly significant number of warning letters. This is a step above and beyond issuing a 483. We issued warning letters to 65 firms and we did this when we found a combination of one or more insanitary conditions and failure to implement effective pathogen preventive controls. Again our emphasis was on microbial testing. There was some misconception since we did not give the field authority to issue warning letters based on the absence of seed disinfection that FDA no longer thought seed disinfection was important. The reason we didn't give that direct authority was that seed disinfection has many complexities and it would have been too difficult, and we still haven't come up with a tool to fully describe to the field investigators what would or would not constitute an effective treatment, the variation between tolerances of different seed types and all those issues. So when it came to seed treatment, this is still important, we gathered as much information as we could but we did not make that a criteria for the warning letter.
Okay. We found that at 54 firms there were no significant deficiencies noted. We also found that firms that were inspected in 1998 did better in 2000 than firms that were being visited for the first time. So maybe there was some advantage either to FDA presence or to increased awareness from having been visited before.
Some of the categories where we saw deficiencies include personal cleanliness, things like hand washing facilities, rest room facilities, their condition, accessibility, even their existence, insanitary food contact surfaces, how they were cleaned, what they were made out of, the presence of pests, including insects and rodents, and water quality issues. Things like maybe having a private well as a water source and the private well had never been tested to ensure water quality.
Now, we said earlier that it looked like the guidance was doing some good for a little while. What we have seen in 2001, 2002, a single outbreak associated with alfalfa sprouts, which may or may not have been mixtures of alfalfa and clover because we're starting to become more aware of that practice. In 2003 there were five outbreaks. This is one short of the summer of the '99. In 2002 or in 2004--two outbreaks by mid 2004. So this raises the question that was mentioned just a little while ago about the adequacy of the guidance.
Some of the initial reports from the investigators investigating the outbreak when they have been able to trace back product to an individual facility were starting to write in their report that the sprouter appears to be following FDA sprout guidance.
Now again our broad guidance is the equivalent of five bullets so our first question was does the investigator know enough to assess accurately whether or not the guidance is being followed. And we drafted questions here in house that we've shared with investigators whenever we've become involved to kind of help them ask the second and third level of questions to get at whether or not the guidance is being consistently and appropriately applied by those firms that say they're following the recommended practices.
In all fairness, this also raises the question about the adequacy of the current guidance. Is there something different we should do? Is there more or less or some other way that the guidance should be revised to be more effective?
The most recent information we have about practices within the sprouting industry comes from a joint California Department of Health Services Food and Drug Branch and FDA Inspection that was initiated in February 2004. This was an inspection of all registered sprout facilities in California so again the data that comes from this you need to be careful about extrapolating it to national numbers but I think that some of the observations that they made in this assignment are or should be serious food for thought in what we do next as we go forward. Again they used the standardized questionnaire that was largely based on FDA recommendations.
This is the inspection checklist that was part of the inspection so this is a list of everything that they looked at.
In this particular assignment 50 percent of the firms were described as having deficiencies in the same four areas that were noted before. Numbers are somewhat different but again this was not designed for direct comparisons.
When looking at seed treatment the majority of facilities visited employed some type of seed disinfection treatment. Seventy percent of the facilities were using calcium hypochlorite, 25 percent of facilities were using sodium hypochlorite, ozone and peroxyacetic acid were also used. However, only two facilities, if you look at all the steps that are recommended for the seed disinfection treatment with 20,000 parts per million calcium hypochlorite, only two facilities used the correct concentration, the recommended time and the best method, including agitation and consideration of the seed solution ratio. So this indicates to me that there is at least a strong possibility that the folks that are doing seed disinfection treatments may need a little bit more help in the steps to follow to do that the most effective way.
Many firms, 71 percent of firms, collected spent irrigation water for microbial testing. Almost all firms tested for Salmonella and E. coli O157:H7 but the testing method varied greatly and some of our colleagues here will get into testing in a lot more detail this afternoon.
When it says "unapproved test" we cited several tests in our guidance document. That doesn't mean that you can't use alternative tests but if you're using a different test than the one that we cited you should have some confidence and some experience that it really does work on spent irrigation water.
California also noted that they had some issues with who does the tests and where the tests are done, qualified people in a controlled environment, and also pooling has the potential to dilute pathogens if they're present, and holding samples for an extended period of time. If pathogens are present they could die off in that sample and give you a false negative which is a false sense of confidence, a waste of money, and a public health concern.
Sixty-five percent were conducting confirmatory tests. Many firms said that they have never had an initial positive but would do confirmatory tests if they saw one. A little more than a third of the firms were using the enrichment media for confirmatory testing and this is what microbiologists would recommend.
Almost half the firms wait to ship until the results have been received, and again this is from the confirmatory testing or the follow-up testing to an initial positive most likely with the rapid test kit.
One area certainly where more could be done is the issue of record keeping. One of the firms visited maintains a record of sampling for microbial testing but no records of the outcome of that sampling and this would also help us to have information like this as we look at the incidence of positives.
Less than 20 percent that conduct confirmatory testing maintain records of positive results from that so there's even less record keeping further along the line and most firms do not contain or do not maintain records of what they do when they find positives, how was the product disposed of. Now this may be kind of the philosophy of don't ask, don't tell or we don't want to put anything on paper that's not good news but this really would be to the benefit of all people involved to maintain records of their due diligence, their appropriate actions, and also would help us in investigations to know what happened, and to have documentation to support that knowledge.
Traceback is another area. A larger proportion of firms report having the ability to identify their seed source than firms that reported having some kind of lot number or other identifying data on finished product. Absence of this information makes traceback very difficult. Traceback is even harder when different seedlots are mixed and the California survey found that for every production lot of sprouts that they looked at from one seedlot up to as many as ten were used to make that lot of sprouts.
Dr. Brackett mentioned the Produce Safety Action Plan that was finalized in October 2004. This is the website for that action plan. With some other commodity groups we've made the suggestion that they go visit the action plan and look at it and see if there are ideas about things that could be done. It covers risk assessment, education outreach, research components, just a lot of things that could have application here.
It's on our program priority list for this year to hold a public meeting. We'll be able to check that off after today so thank you all.
As individual tasks are identified they also make it on to our to do list and one of the tasks that we have on our priorities list is to evaluate testing protocol for the recovery of Salmonella in sprout seeds. Now the actions in the Produce Safety Plan and anything that comes out of this collaboration might be individual group actions, they might be collaborative efforts but to make true progress we really need the work on the part of all parties.
The Food Code has defined sprouts as a high risk food. Cut cantaloupe is a high risk food. There are a number of things on that list. I think by your presence here and your interest that's an indication that there's appreciation that a rigorous risk reduction strategy is needed. The question that we're working on now with your help is what should the strategy include to help us answer the who's, how's, when's and best applied to get the most appropriate effect of the best possible solutions.
The Federal Register document announcing this meeting set out a number of questions to kind of help focus comment on the areas that we're interested in getting more information on. This is my short list. My personal favorite is how can we better reach seed producers and distributors. We've said all along that this is a collaborative effort. It involves all parties at every step along the supply chain. Our Produce Safety Action Plan no longer focuses just on the farm and packing house. We've extended that to cover the entire supply chain and that would be an approach that we would most like to use with sprouts also.
In addition to this public meeting, we have a comment period that runs until July 18th and the instructions for submitting additional comments are in the Federal Register notice for the meeting.
I thank you for your time and attention.
DR. BERU: Thank you, Michelle. I would like now to invite you to sit up here together with Dr. Dechet.
I know we're running a little behind time but we'll have a short question and answer session.
As I said before, please use the mikes. We are recording this and we'll be having a transcript made of the meeting which will be posted on our website so when you have questions either step to one of the microphones or they can be handed to you.
Yes, please?
MR. SANDERSON: My name is Bob Sanderson. I am president of the International Sprout Growers Association and I would like to point out what--I may be hearing things that aren't there but something of an inconsistency in Dr. Dechet's presentation and Dr. Smith's.
Dr. Dechet spoke about the chlorine recommendation of the guidance and discussed it at some length and then it seemed kind of as an aside and said, "And also there is the testing." And Dr. Smith pointed out that when they were evaluating compliance--when the FDA was doing this they said, "In particular, seed testing or testing procedures."
And I have a feeling that there has been a mixed message on this emphasis so I think that's a serious problem because growers really are counting every penny and they're going to put those pennies where they really think they'll have to and the power of the inspector is huge. Okay. Thank you.
DR. DECHET: In terms of my reference to the chlorination process, certainly the sprouters and the growers would have much more information about that. I really use that more as a sort of time table to talk about some of the interventions that--or the guidelines that were issued. Probably Michelle can speak a little bit more about that but we would, you know, really defer.
I mean, our job at CDC is really to detect the outbreaks and report that information, and I think sort of actual guidelines and who is following those guidelines and what the emphasis is of those guidelines really is best left to the FDA.
DR. SMITH: And I think maybe another reason CDC focused on the seed disinfection is that for a long time it looked as if the firms that were disinfecting seed with 20,000 parts per million calcium hypochlorite were not involved in the outbreaks, whereas firms using the same seedlot that weren't consistently or appropriately applying 20,000 were the ones that were having the outbreaks so that put kind of a spotlight on the seed disinfection treatment. At the same time there are issues with the 20,000 parts per million. Not just whether it's being used appropriately but the impact that it has on seed, whether or not it's consistent with organic production, the fact that some types of sprouts, not necessarily the major ones but some of the other types can't tolerate that kind of seed treatment. It's very complex.
And then finally there is research about pathogens surviving that treatment and recovering during sprouting to the point where they can have a foodborne--cause foodborne illness. So our last hurdle, the final thing that people can do to make sure that contaminated product is not shipped is the microbiological testing.
We are looking at a multiple hurdle approach. I understand people want to do the one thing that can make the most difference and our guidance does provide for alternative approaches if they do not violate laws or regulations and if, hopefully, they get you to the same food safety place. That second part is really a hard call. I tend to take calls from the field that observe something that is just woefully inadequate and I can say that's not an appropriate alternative but there's a huge gray area that I think we need more information to map out better.
DR. BERU: Yes, please?
MS. SANDERSON: My name is Barbara Sanderson and I'm from Jonathan Sprouts also. Michelle, I really appreciated your reiterating the guidance where it said seed disinfection such as...and I have--I would like to point out a situation that happened in the industry. It hasn't to do with your recommendation but how it was used and I believe it began with an outbreak where a grower was using a combination of a heat treatment and 2,000 parts per million calcium hypochlorite and still had an outbreak. The lawyers used this information to turn your guidance into a rule that we had to use 20,000 parts per million calcium hypochlorite and there was no way--that kind of put a damper on getting any other kind of treatment into use or even into the visibility of how effective it might or might not be with sprouts so that we really got paralyzed by the legal profession.
DR. NORTON: I'm Dick Norton. I'm a retired microbiologist from the Food and Drug and working with different companies and asepsis for the last 17 years now. Currently I'm working with a small company with asepsis and we've sent the results of Dr. Reiser's tests on alfalfa sprouts for this. It's something new to this field. We have been working off in a little corner somewhere else and I don't think it's generally recognized here but we've been working with this fatty acid combinations for 14 years now with Tyson's, with various meat, types of meat and fish, and we've been marketing products for hand anti-asepsis in hospitals. So we're unknown in this field but we have background and your question as to how can we all put this together got me interested in finding out how we can help with this and our interest is in treating seeds. It turns out there's no effect on germination rate. There are safe compounds that are cheap so if there's any interest in this we would like to work with these people and unfortunately I have to go to the EPA on this very same subject at 1:00 o'clock so I can't stay around for the whole day so if anybody has any questions.
DR. BERU: Thank you. We are running a little behind time so let me suggest that we will have Dr. Dechet and Dr. Smith also join the next set of panelists during the question and answer session so if you have any additional questions let's hold them until then and let's take a break until 10 past 10:00 and, as I said, we have refreshments in the area where we registered.
Thank you.
DR. SMITH: And as Dr. Beru mentioned, you're all on your own for lunch but I have a few copies of the menu for the cafe that's right out the front door and I'll tape the last copy to the table and put a stack out there when I get up.
[Whereupon, a break was taken.]
DR. BERU: Thank you. Our next presenter will be Mr. Bob Sanderson and he will present--he is president of the International Sprout Growers Association and he will present on the status of the sprouting industry.
MR. SANDERSON: Thank you, Dr. Beru.
On behalf of the ISGA I would like to submit what is our current set of sanitary guidelines, an industry model HACCP and a beginning to attempt to define good agricultural practices for seed.
These things weren't built for my--can people hear me okay if I stand fairly straight?
Dr. Smith suggested that I provide an overview of the sprout industry's, as she put it, strengths, weaknesses, needs and desires.
My talk is not going to be the ISGA's comment per se. That will be submitted prior to the deadline in July but I'm going to try to talk in more general terms about the sprout producer and his relationship with product safety issues and their requirements.
In discussing the sprout industry's strengths and weaknesses, there is the product itself to consider and there are people who are involved in producing sprouts, and I think any discussion of the people has got to factor in the kinds of rules and regulations under which we're operating, whether they're clear, consistent and effective in achieving their intended purpose.
The product itself is remarkable in some obvious ways. Sprout producers may plant from one to several crops a week, 52 weeks a year, with an interval of from four to ten days between beginning the process and shipping the product to the market. What happens during this four to ten day period is a combination of very rapid chemical and biological processes which transform a mostly unpalatable seed into a nutritious food.
In addition to being nutritious, it appears that many, if not all, varieties of sprouts contain high levels of one or more phytochemicals, which may have significance to human health. The understanding of these properties is still in the early stages.
The very rapid growth of sprouts and the conditions in which they're grown present unique challenges in terms of food safety as well as some unusual opportunities, which I'll come back to in a moment.
Regarding the people who grow sprouts, it's a very diverse group. The largest in terms of numbers of producers and amount of sprouts produced in the U.S. and certainly in the world as well are those involved in the growing of mung bean sprouts, which have been a staple food in Asia for thousands of years. The other main group is companies, which beginning about 40 years ago, began to introduce a variety of sprouts, which historically have not been widely used as a human food. Increasingly, more and more sprout producers are combining the growing of the traditional sprouts and the more recently developed varieties so the industry is a mix of people from very different cultures. Some carrying on with the family business which may have been started generations earlier and others who are relative newcomers.
The increase in concern with sprout safety seems to have coincided with the appearance on the market of the newer types of sprouts so, as Dr. Smith mentioned, there may be some feeling on the part of the producers of the more traditional sprouts that they've been caught up in somebody else's problem. After all, these types of sprouts have been grown for many generations and wouldn't we have known about safety problems long ago?
Although it may be argued that different types of sprouts, which are used in different ways, may require different risk reduction strategies, it's not accurate to say that any particular type of sprout is traditional because the nature of the market, consumer preferences, production methods continue to change very rapidly. This is true both for the producers of bean sprouts and the newer green leaf sprouts since both are functioning in the context of increasing food safety concerns and both have to deal with continually increasing regulatory and third party requirements as well as changes in the nature of the market and consumer preferences.
There are some other groups with their priorities within the sprouting community. The ISGA being an international organization has members from many different countries who have quite different perspectives but since the ISGA core membership is made up of U.S. growers the association tends to have a focus on FDA regulations and food safety which some growers operating outside the U.S. seem to view as a kind of negative fixation.
After all, the ISGA was started to promote the positive aspects of sprouts, not to be talking about safety all the time and, furthermore, sprouts seem not to be considered such a high risk in many other countries. But the issue isn't simple because of differences in types of sprouts, how they're usually consumed, total volume sold, as well as differences in available public health monitoring and epidemiology.
The FDA's recommended 20,000 ppm chlorine seed treatment is generally considered very excessive by growers from other countries where in some cases the use of this treatment wouldn't be allowed. Even among U.S. growers it would be high on the wish list to have an approved treatment which did not create such an irritating and hazardous working environment.
It would also be a good thing for the ISGA as an international association to have a single internationally acceptable set of safety practices or at least an agreement on underlying principles, which isn't to say that sprout growers all around the world would apply these equally but at least we would have a common frame of reference.
Another point of debate in the sprout industry which exists inside the U.S. as well as between the U.S. and the rest of the world is the status of organic sprout production and, as I think someone mentioned, sprouts kind of is associated with organics, which is kind of ironic in a way nowadays, again primarily relative to the 20,000 ppm chlorine treatment recommendation. Although some organic certifiers have allowed the use of this 20,000 ppm treatment, the basis for this allowance is felt by many to be quite a stretch with organic production standards and is based on the need for organic standards to take second place to FDA safety requirements in any situation where there may be a perceived conflict.
This is entirely appropriate and necessary but unfortunately there isn't presently a clear way to evaluate the effectiveness of risk reduction strategies which might be more consistent with organic production methods.
So the ISGA's wish list might also include, if possible, the allowance of safety protocols which were more consistent with organic standards. This isn't to suggest that safety criteria should be diluted in order to be acceptable to different groups but that, if possible, safety requirements should be based on end product criteria rather than on any specific method of getting there.
One aspect of sprouts which many consider to be their greatest drawback is that they have proved to be extremely resistant to treatment based approaches to assuring their safety. This is because, and this is very much in a nutshell, sprouts--with sprouts any sanitizing step is followed by four or more days of growth at room temperature. However, the same characteristics which make sprouts difficult to sanitize may also make them accessible to more thorough sampling and testing than is possible with most foods.
The sampling and testing of seedlots prior to use in sprouting with seed which test positive for pathogens being diverted to non-food uses is a common sense preliminary step. The fact that in several instances sampling and testing of isolated pathogens from implicated seed following outbreaks clearly suggests that if the same sampling had been doing prior to the use of this seedlot for sprouting these outbreaks wouldn't have occurred.
Bob Rust is going to go into more detail on ways to carry out this initial screening of seedlots.
Since sprouts emerged as a significant health concern in the late '90s there have been dozens of attempts by leading food safety researchers to develop effective sanitizing interventions. These investigations continue into the present and it may be that in the near future a truly effective seed sanitizing procedure will be developed which is affordable and which doesn't entail significant risks to sprout growers or have other serious drawbacks or possibly such a procedure already exists and, if so, then one can only hope that it will get a speedy regulatory approval.
In the event of the allowance of such a treatment, one question will remain and it will need to be addressed. It's whether the use of such a treatment would eliminate or significantly reduce the present need for every batch spent irrigation water testing.
I don't know of anyone who presently is proposing that this should be expected at least in the near future and this is a very important question because testing is very, very expensive and if you introduce the idea of intermittent or periodic testing in a very competitive market there will be a significant economic incentive to minimize it. This may lead to even more confusion about what constitutes compliance, who is in compliance and who isn't, which will not help the overall level of confidence in the market.
So while we're waiting for improved treatment interventions or even if we find them, it seems worthwhile to consider how effective the recommended testing procedures are. The 1999 FDA guidance recommends that the spent irrigation water from all production batches be tested in duplicate for the two pathogens of concern and that negative test results be back in house before any product is shipped from the facility.
In preparing for this meeting I have tended to assume that my company's testing program could be duplicated by other sprout producers but we are fortunate in being an hour away from a qualified testing lab which is very responsive to us and which charges us very reasonable rates for its services. For other growers I've heard that lab costs per test can be much greater and some may have to overnight ship their samples which will add a full day before they can get their lab results back. This will add significant problems to inventory control as well as hold and release programs which is that you don't let anything out the door until you've got your results back.
So if this every batch testing is going to be a necessity until some significantly better treatment is developed, things like cost per test, how responsive a lab is, how long it takes to get the sample to the lab, how long it takes to get the sample results back are very important.
To put this in perspective, if my competitor and I are both doing all the required tests but he's doing duplicate testing and I am only doing single samples for each test, I will save enough money on testing alone to offer a price which will allow me to take my competitor's business and at the same time make more money at the lower price than I'm making now. This testing is very expensive and one thing on many growers" wish list is that the required testing could be significantly reduced.
One bean sprout grower from outside the U.S. told me that if he tried to do all the kinds of testing recommended in the FDA guidance he couldn't possibly remain in business.
But I feel it's important to come back to the question do we need to do this testing. It seems that until some treatment comes along which clearly indicates that we can cut back on our testing we need to do it and so we have to focus on how to make it more effective and more consistent.
High testing costs are frequently mentioned as a burden to sprout producers but I think this question needs to be looked at in context. Are they a burden because the retail price of sprouts is as high as it can be and consumers will just stop buying them if the price goes up? Or are they a burden because every grower is trying to survive in a very competitive market? And a difference of pennies per package can be a determining factor in obtaining or keeping an account with a supermarket customer.
In talking about the costs of the testing program, I'm talking about something in the range of ten cents a package wholesale cost. If you ask a sprout producer what his bottom line would look like with an extra dime per package coming in, I think you'd see quite a reaction. In my own company this--and this is, I think, literally true--would finance an entirely new facility and give everybody a raise at the same time.
So an important question about the burden of these testing costs is the price sensitivity of sprouts inherent in the product or is it dependent on perceived value so that if this value goes up the customer will readily pay the extra amount. And I think there is good evidence at least from some markets that customers will readily pay more for sprouts if they have a reason to believe they're getting a better or safer product.
When the FDA guidance were issued in 1999 sprout producers or sprout products were redefined. They still looked and tasted the same as they always had but the costs of producing them to an adequate standard had increased substantially. At the same time it was left up to the industry or the individual producer to convince the customer that the new improved product which looked and tasted just like the old one was worth the increase in price.
Since the supermarket buyer is under considerable pressure to buy the least expensive product, it's the producer's job to justify his higher production and safety costs but neither the supermarket buyer nor the consumer has any way to evaluate the safety claims of the producer. This can encourage marketing strategies which play upon customers" insecurities.
In the present guidelines the recommended treatment and testing protocols are preceded with the qualifier "e.g." which means "for example," which suggests that what is recommended is only one option out of several but in practice these guidance recommendations are very strictly interpreted and have acquired the force of regulations.
Deciding what, if anything, might be considered "e.g." is a difficult thing to do in part because it isn't clear what the treatment referred to actually accomplishes. The sprout industry would like treatment and testing options to be based on the best available science and we want, if possible, for them to be flexible so that "e.g." can allow for a range of approaches provided they achieve an acceptable end result.
There was an attempt several years ago for the ISGA to take responsibility for setting safety standards by way of a seal program. Two problems were encountered. One was that at the time the seal program was being developed there had not been very thorough inquiry into the effectiveness of the safety protocols which were then available. For example, there was no consideration at that time that growers could do this every batch sampling. The other problem was that the ISGA was not in a position to effectively police compliance with the requirements of the seal program as it wouldn't be today.
Whether we have a guidance recommendation or a regulation or whatever the structure, it needs to be responsive to developments in treatment and testing technologies and as flexible to the needs of individual companies as possible. Although the ISGA can't police this, clearly the FDA can't immediately review every new idea that comes along.
And a question, I think, underlying this is, is it worthwhile to evaluate safety methods for a very small industry which might be quite different from what is used with most foods? Of course, it's worth it to the industry to solve its problems and to prosper but are the sprout industry's challenges relevant to other areas of food safety or research generally? If we consider the testing challenge in its simplest form to be the challenge of quickly and accurately telling friend from foe in the microbial world, this would seem to connect the sprouting industry's needs with many important research areas. Therefore, the industry needs to continue to work with people in government and academic research who have qualifications and review capabilities necessary to develop effective sprout safety standards and procedures. The ISGA technical review board can provide a framework for this effort.
Allowing for flexibility and safety protocols has got a number of interrelated parts. There is the question of how well something works in a research setting and how well it would translate into a production setting. This has repeatedly come up in the case of the 20,000 part per million chlorine treatment recommendation with some arguing that lab results using inoculated seed suggests a very high level of effectiveness in the real world with others arguing just the opposite, and I think there's good arguments on both sides.
Another challenge is how can compliance with a number of different methods be evaluated by food safety and third party inspectors. It's certainly simpler for an inspector to evaluate a single treatment and testing protocol for all producers in a given category than to evaluate several which might differ from company to company.
And it becomes even more difficult when, as in most cases, the sample leaves the building and is delivered or overnight mailed to a lab. Is there any way the grower and his food safety auditor can be assured that the lab is doing the testing in a way which will provide the best likelihood of detection of pathogens if they're present in the sample? This may require skills which are not within the safety inspector's usual job description.
The challenges of developing good sampling protocols, assuring the best testing methods and providing adequate inspection criteria is another area where the ISGA technical review board can provide a significant contribution by working with growers to develop appropriate inspection checklists for treating and testing options.
So as long as we have the need for this testing, we might as well look at it as an opportunity and make sure it's being done as well as possible.
If the playing field is as level as possible and the methods are as good as possible, the added costs may actually benefit the entire industry by raising the standard of acceptable of the product in the whole market. In the meantime we can hope that treatment interventions are developed which will make the sprout producer's life much simpler. Perhaps some day requiring only a minimal amount of microbiological monitoring.
Most sprout growers are acutely aware of the microbial hazards which are possible with their products, not through any choice. One of the greatest strengths of the sprouting industry is our collected awareness of microbial risk and our growing knowledge of food safety. This may not only be our best resource for our industry's future but may also provide opportunities for learning which would be relevant to many other areas in the food industry as well.
I believe in the past calendar year there haven't been any reported outbreaks connected with sprouts. I don't know if the last 12 months--I'm not sure if that is the calendar year but May to May, which is a very good indicator of significant improvements in the industry. We need to focus our energies on how to increase our margins of safety, restore confidence in sprouts, and make the sprouting industry a model of food safety.
Thank you.
DR. BERU: Thank you, Mr. Sanderson.
The next presentation will be on Seed Handling and Distribution Systems and will be made by Bob Rust, International Specialty Supply.
MR. RUST: I just wanted to thank Dr. Michelle Smith and the FDA for inviting me and giving me an opportunity to discuss a subject that I'm passionate about.
In order to stay within the allotted time I recorded the presentation and it will be available after this meeting in the Seed Safety Section of our website, www.sproutnet.com.
[Video presentation.]
Hello, I'm Bob Rust, owner of International Specialty Supply, with divisions of Prime Seed Company, Prime Packaging, Centrix Equipment Company and Sun Garden Sprout Company.
We also test sanitation products and processes for other companies and we have a pathogen testing laboratory. We do consulting on such things as GMPs and HACCP. We write a newsletter called the SproutNet and have an informational website, www.sproutnet.com, with most of the research related to sprout safety.
I appreciate the honor of being invited to speak regarding seed handling and distribution systems. The world has seen 26 sprout related outbreaks since 1998, of which 25 involved sprout growers in the United States and Canada. The FDA stated that they believed that the source of the contamination in most sprout related outbreaks is the seed. It's impractical for sprout growers to line up small quantities of seed from farmers all over the world so seed companies who specialize in sprouting seed contract the production with farmers and work with seed processors near the farmer to process the seed.
It's difficult to predict how much seed to contract and crop failures are common occurrence. When this happens, seed companies will purchase seed from other seed companies who may or may not specialize in sprouting seed. Although there may be thousands of seed companies throughout the world, there's only a handful that specialize in sprouting seed.
There are three ways the seed industry can improve its record of shipping contaminated product to sprout growers. It can grow, harvest, process, store and ship seed as though the seed were food product. It can decontaminate seed destined for sprouting and it can screen the seed for pathogens prior to shipping it out.
As the owner of a seed company and as a commercial sprout grower, we've put all three of these methods to the test. There are so many farmers and processors involved in so many parts of the world that our attempts at controlling the production was unrealistic. There are some good decontamination possibilities on the horizon but it may take several years of actual field use to determine if they are as effective as they appear.
The last one, seed screening, is something our company has been developing since 2000. There has been 13 sprout related outbreaks since we started our sampling protocol and we're convinced that it's our seed screening process that has kept us from being involved in any of these outbreaks.
Seed screening is a simple approach to risk reduction. The idea is to determine if the seed is contaminated prior to selling it for sprouting purposes. The Camden Research Group in England in their 2004 report titled "Review of Microbial Risks Associated with Sprouted Seed" concluded that the absence of pathogens in seeds is critical and, consequently, microbial testing of seeds prior to use for production of sprouts is essential. Seed sampling is also suggested in the Codes of Practice of Food Safety in Ireland and the Ontario Ministry of Agriculture and Food is adopting its recommendations for seed companies and sprouters.
In early 2000, Bob Sanderson came up with the idea that if the source of sprout related outbreaks is often the seed maybe we should check to see if the seed is contaminated before we use it. Hmm. Check to see if the seed is contaminated before we use it? We thought this was a great idea so in conjunction with Jonathan Sprouts we developed a process for screening seed before it sprouted. When seed arrives it's placed in a quarantined area and inspected for evidence of mouse droppings on the bags, holes in the bags where mice or insects may have entered, insect larvae, bird droppings, that sort of thing. The bags are black lighted for traces of urine.
In order to find contamination in seed prior to sprouting it, a pathogen must be captured for identification. Alternatively, one may capture and identify evidence of pathogen contamination. Twenty-five grams of sample from each and every bag. If the sample comes to less than three kilograms, enough bags are re-sampled in order to get three kilograms.
The composite sample of seed is very carefully inspected for indicators of contamination with both a magnifying glass and a microscope to determine its fitness for human consumption. The entire sample is sprouted using commercial sprout reduction methods, the seed is not sanitized prior to sprouting. A sample of the runoff water is collected using FDA procedures recommended for commercial sprout producers. The water is then enriched and tested for Salmonella and 0157:H7. Everything is documented and signed by the person doing each procedure, their times, such as drop shipments directly from the country of origin where sampling and testing isn't practical, in these cases no documentation is provided and the sprout grower needs to perform the sampling and testing procedures prior to using the seed.
Neither this certificate nor the procedures we perform is a guarantee that the seed is not contaminated. It's merely a risk reduction step.
We have an extra step as well. Before we receive a shipment we bring in a sample and we inspect it, sprout it out and test it. We stop at the point of rejection. That is if the seed doesn't pass visual inspection, we reject it without taking the time to sprout it out.
Recently when I mentioned to a researcher that we found pathogens four times, she was shocked that it was only four times. There have been 13 sprout related outbreaks since the year 2000. If these four lots had not been screened out there would have been 17 outbreaks instead of the 13. That's 31 percent more outbreaks. I think we would find more except seed with visible contamination never makes it past our inspection process and by doing what we're doing we learn whom the safe seed processors are and who to avoid so it's also a supplier screening process.
For over 100 years seed has been sampled and tested for germination, purity, hard seed, plant pathogens, and other properties that relate to the quality of the seed. The statistical probabilities used to determine these percentages is well documented and extremely accurate.
Testing seed for human pathogens can be even far more accurate. When testing for human pathogens we're not looking for percentage but for any at all. If a single pathogen is detected the lot is contaminated and can't be used for sprouting purposes.
When it comes to seed sampling for human pathogens, sample size and total contamination per lot are the two factors that determine the probability of capturing a pathogen.
There is a possibility that two or more pathogens could be lodged on one seed. This makes our probability charts less reliable so we base probabilities on contaminated seeds rather than on CFU. Seed while being processed does get mixed very well, well enough for very accurate sampling estimates.
For ease of explanation throughout the rest of this presentation, all samples will be 25 grams and all bags will be 25 kilogram bags so the sample size is always 1/1,000th of a bag or 1 seed per 1,000.
Some question the reliability of sampling because there is a possibility that pathogens can be in a corner of the bag or in a clump and never detected. Anything is possible but this scenario is extremely unlikely. The seed is harvested, transported and dumped into a silo or bins. It is then poured or agered into the seed cleaning equipment, processed and poured into a bag. The cleaning and grading process doesn't allow even two seeds to clump together or they won't fit through the screens. Seed with pathogens are not going to stay next to each other throughout this process. They will be somewhat, if not thoroughly, distributed.
When trying to detect plant pathogens, similar sample sizes are used and the probabilities are extremely high as well. When looking for plant pathogens you are looking for frequency rather than any at all. In order to determine the percentage of pathogens in wheat, eight kilograms is sampled for each 100 tons of seed. Then 300 seeds are pulled from that eight kilograms for testing. Distribution of the plant pathogens is good enough that this method is very accurate. In a same lot size we would sample and inspect the lot, then 25 million seeds would be tested in order to find a single human pathogen.
Larger samples increase the probability of capture at a given contamination rate. Considering that we sample at least 1/1,000th of a seed, the larger the lot, the larger the sample. If you have seed that is contaminated at one seed per kilogram, pulling one sample from one bag would only get you a 2.5 percent chance of finding it but, if you didn't find it in the first bag, you have another shot with identical odds in the second bag. The more bags there are the more 2.5 percent shot you got at it. You get enough 2.5 shots, say 400, and you have a 99.99 percent chance of capturing at least one of those contaminated seeds.
But what if the pathogens are in just a few bags? This is a problem if you're trying to find a particular level of contamination but it is not a problem if you are trying to find any at all. What matters is the total number of pathogens in the lot, not how many bags they're in.
This chart shows what happens if you sample various size lots in which all lots have 2,000 contaminated seeds. Notice if you have one contaminated bag, you have 2,000 contaminated seeds and one pull will capture one of those seeds 86.5 percent of the time. If you divided those 2,000 seeds among two bags, now you have 1,000 contaminated seeds per bag but you have doubled the number of pulls and the odds even out.
Our charts are actually based on the odds of capturing clean seed, then we reverse the numbers in order to predict the number of contaminated seed. If you tried this with small numbers such as a few marbles in a cup, the odds will change as you move the marbles from cup to cup but there are about 12.5 million seeds in a bag. In this example 1,000 seeds is moved into another bag with another 12.5 million seeds also. When you move 1/100,000th of the seed from one bag to another the number of clean seeds is virtually unchanged so the probabilities for all practical purposes remain the same.
This next chart shows a large lot in which--except in the bottom row--is unevenly distributed among 800 bags. The first row has all 2,000 seeds in one bag. Your odds as in the previous slide are 86.5 percent but it doesn't matter that you pulled seeds from the 799 bags that are clean. You pulled one pull from the one bag that was so contaminated that it gave you an 86.5 percent chance of finding one contaminated seed.
Some say the blending makes seed sampling unreliable. Blending dilutes contaminated seed per kilogram but it has no effect on the total number of contaminated seeds and, therefore, no effect on the probability of capture.
As an example, two bags of seed contaminated at the rate of four contaminated seed per kilogram has 200 contaminated seeds. If it's blended in with 800 bags of non-contaminated seed the new lot still has 200 contaminated seeds. The probability of detection by pulling 802 samples is 18.5 percent. These are the same odds as if you had pulled a sample from each of the two contaminated bags before they were blended in.
However, using our seed sampling protocol on the two bags, three kilograms would have been pulled for testing. This increases your sample size from 1/1,000th to 1/16th. The odds of capture go up to 99.9994 percent. So blended lots are okay as long as the seed is screened properly before the lots are blended.
So why is it hit and miss when health officials try to find pathogens in seed that they are certain caused an outbreak? It's the total number of contaminated seeds in the lot that determine the probability of capture. Seed companies can screen the seed when the entire lot is intact. This is when the total number of contaminated seeds is its highest. If just a portion of that lot is contaminated, the seed in the contaminated bags are included in the population that's sampled. By the time the epidemiologists determine that sprouts are the most probable cause of an outbreak, a good portion of that lot is gone and a portion, if not all, of the contaminated seeds was used up in the outbreak.
There's something else that should be pointed out. The effectiveness of seed sampling is inversely related to the effectiveness of chlorine. The more contaminated the seed is the less effective seed sanitizing is. Yet the more contaminated the seed is the easier it is to detect a pathogen using seed sampling and testing. Seed screening along with chlorine or other forms of decontamination complement each other very well to reduce the risk that Salmonella or E. coli O157:H7 is in sprouted seeds.
Is seed sampling too much of a burden on the seed industry? Well, first let's look at what sprout growers have to go through in order to ensure that their sprouts produced from the seed are safe. An ISS Rototech Rotary Drum uses 50 pounds of seed to produce one batch of sprouts. The FDA recommends each batch of sprouts be tested separately and that 12 pounds and 13 ounces of chlorine be used to sanitize 50 pounds of seed.
At a $1.55 per pound the chlorine costs about $20.00 to sanitize the 50 pound batch. Runoff water is collected and sent to a lab to be tested in duplicate for Salmonella and E. coli O157:H7. The best price we could find shopping around was $25.00 for O157:H7 and $33.00 for Salmonella . Overnight delivery of the refrigerated package is $36.00. Chlorine reduces yields 10 to 30 percent. I just plugged in 10 percent into these figures. Collection, ice pack, packaging, shipping, labor and record keeping are at least
$15.00. I didn't put in any time for management, training, hold and release or false positives. So the minimum it costs a grower who follows the FDA guidelines is $195.50 to sanitize and test one 50 pound batch of seed. This is $3.91 per pound of seed.
The seed screening by the seed company consolidates the efforts and the finances. An experienced sampler can sample 44,000 pounds of alfalfa in six hours and mung in eight hours. This is about $120.00 in labor. The seed and bag inspection takes a trained technician about three hours. This is about $45.00. The seed is about $60.00. Growing and disposing of the sprouts is a couple hours and sending off the sample is $36.00. The FDA recommends the tests be done in duplicate so this costs about $66.00 for Salmonella and
$50.00 for O157:H7 tests. Collecting the sample, packaging it for refrigerated shipping and send it off is about an hour. This totals $407.00, which in 44,000 pounds of seed comes to about a penny a pound.
So the seed company pays $407.00 per 44,000 pounds which is less than a penny pound and the sprout growers pay $3.91 a pound, which in 44,000 pounds comes to about $172,000.00. That's 422 times what it would have cost the seed industry to screen the seeds. With $172,000.00 the sprout grower should have at least got the seed, maybe even the semi that brought it to him.
Seed screening doesn't do the following things: It doesn't cost much. It does not produce hazardous waste. It doesn't put production workers at risk. It doesn't affect germination, vigor, yield or the quality of the sprouts and it doesn't reduce background flora. It doesn't introduce the possibility of resistance. It doesn't disenfranchise organic sprout growers and it doesn't negatively affect or take away in any way from other food safety procedures such as decontamination.
But this is what seed sampling can do: It can help the seed industry identify practices that introduce pathogens into foods. It can prevent contaminated blended lots from entering the market if sampling is done prior to blending. It can prevent seed with visible contamination from entering the market, and this includes glass and other things that don't show up on a pathogen test. It's most effective when sanitizers are least effective. And it can help identify farms and seed processors lacking good agricultural processes. It can be used identically to all types of seed and its application will affect commercial sprout growers of all sizes with all levels of sophistication and using all types of equipment. It can be applied evenly throughout the sprout industry. It can be used on seed destined for home sprouters and it may be the only realistic defense that home sprouters have. Chlorine is not a great option for home sprouters. It would shift some of the responsibility of providing safe seed to the seed industry and it would substantially reduce the number of foodborne illnesses from sprouts.
In conclusion, I'd just like to say that seed needs to be screened for pathogens before it's sold as sprouting seed. It just makes sense. Thanks for listening.
DR. BERU: Our next speaker is Caroline Smith DeWaal, Center for Science in the Public Interest.
[See presentation slides for Ms. Smith DeWaal]
MS. DeWAAL: Good morning. My name is Caroline Smith DeWaal and I don't know how many of you were here--was it 1998 they had one of these meetings or '99--FDA had another meeting on sprouts. Probably Bob was here but I was here as well and I was very interested to realize during lunch that I was eating with one of the sprout growers from Vermont, which is my home state. At that point I think it really hit the sprout industry by surprise because a lot of the people who had entered the industry were people who were really working on producing clean safe food and suddenly to be hit with a major food safety problem with their product was something that I know took the industry by surprise.
The Center for Science in the Public Interest is a non-profit consumer advocacy organization and we focus largely on food safety and nutrition issues. We represent consumers both in Canada and the United States and we're funded by about 900,000 subscribers to our Nutrition Action Health Letter. As I've just noted, we've really been involved with the issue of sprout safety for many years now.
CSPI applauds the Food and Drug Administration for moving towards the creation of a regulation to address foodborne illnesses linked to the consumption of sprouts. The fact that the number of foodborne illness outbreaks associated with alfalfa and clover sprouts decreased immediately after the two sprout guidance documents were issued by FDA in October 1999 signalled that those were steps in the right direction. Even at that time, however, CSPI believed that the guidance recommendations needed to be mandatory and advocated for regulatory rulemaking to commence. The continuing sprout outbreaks over the last five years are evidence that further FDA action is needed to ensure the sustained adoption of effective preventive controls by the seed and sprout industry.
So FDA laid out a series of questions in preparation of this meeting. I only answer questions I want to so these are the three that I decided to focus on: Should the sprout guidance be expanded or revised? Is the regulation likely to be effective in reducing foodborne illnesses linked to sprouts? And how can progress be measured?
Although routine microbial testing is an essential element in sprout safety, FDA should move towards the long-term strategy of implementing a hazard analysis and critical control point system for sprouts.
However, until an effective pathogen reduction step is developed and mandated, sprouts should be labeled as a high risk food.
A regulation is a more effective tool towards reducing foodborne illnesses associated with sprout consumption because it will ensure that all sprout producers are legally required to institute preventive control measures. It really puts all sprout growers on a level playing field.
One of the sprout guidance documents that was issued in 1999, "Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production," recommended specific techniques for the routine testing of every production lot or batch of sprouts for Salmonella and E. coli O157:H7.
FDA should examine how successful this microbial testing has been in the past five years, both in terms of the proportion of the industry following the recommendations and what their results were, and I know we're hearing some of those results at this meeting today.
I'm going to talk briefly about what CSPI brings to meetings like this. I don't just come as representing consumer advocates. I think Bob Buchanan at FDA challenged me a number of years ago to actually bring something to the table so what we started doing is tracking foodborne illness outbreaks with our Outbreak Alert Database. It right now contains about 4,500 outbreaks with both known food and known etiology which have occurred in the U.S. between 1990 and 2003. It is compiled from multiple sources, largely especially in recent years from the Centers for Disease Control and Prevention, which publishes an outbreak line listing but they don't organize it by food groups so we take their data and reorganize it so we can actually track it by the food groups but we also take data provided by state health departments and scientific or medical journals.
By linking the outbreaks to specific foods, CSPI is able to alert consumers of food safety hazards and provide better information for food safety resource allocation.
So this is what our data--I'm going to go from the broad dataset to the more narrow issue that we're dealing with today. Between 1990 and 2003 FDA regulated foods were linked to nearly 3,000 outbreaks and over 83,000 cases of illnesses. These FDA regulated foods constituted 66 percent of the outbreaks listed in the Outbreak Alert Database, which again you only get an outbreak alert if we have known food and known hazard, and it's 60 percent of the cases.
And this shows FDA has the lion's share of the outbreaks and the USDA the meat and poultry products, which we normally associate with foodborne illnesses, actually are smaller contributors.
So here is our trends in outbreak reporting on produce. Produce was the food category associated with the most foodborne illnesses linked to outbreaks. This was a surprise when we first started to find this. We started publishing our data in 1999 and it took--we had to actually FOIA the information from the CDC because they didn't want to give it to us. As you see, the early years of the database is much less robust because CDC actually wasn't--they started electronic reporting of outbreaks to CDC in 1998, I believe, and so we started getting a much better dataset. I know you've heard from CDC this morning but what you see here is produce. Both the outbreaks and the illnesses from produce are quite significant.
And here we've got the top causes of produce outbreaks from 1990 to 2003 with norovirus at the top and the two of greatest concern to the sprout industry is Salmonella and E. coli .
Okay. This data reflects probably what you've already seen this morning from CDC that the principal pathogens of concern here are E. coli , not just O157:H7 though, there are other types of pathogenic E. coli strains, and then a large variety of Salmonella strains.
Okay. I know we've talked a little bit this morning about this outbreak. This was a 2001 outbreak. In our last meeting actually we looked at a number of outbreaks and did these kind of profiles and they were quite interesting. This one is a little bit different. It was 32 cases of illness, which is relatively small. Still significant. It was focused in California, Arizona, Colorado and New Mexico. And three of the cases involved or required hospitalization so we had some high risk individuals who ended up getting very sick in this outbreak.
What was interesting is that it found that there was a single seed source, a single sprouter and a single seedlot were associated with the illnesses but the seeds had been imported from Australia and had undergone, as we've discussed earlier, multiple decontamination steps, both heat and low dose hypochlorite solution.
Now I use this outbreak to illustrate a couple of points that sprout producers often are not the source of contamination. Contamination frequently appears to occur earlier in the production chain. That seeds intended for human consumption must be protected from exposure to manure, animals and contaminated water; that contamination decontamination treatments need to be routinely and systematically monitored for effectiveness; and finally that production conditions in other countries need to be evaluated prior to seed import to ensure that the growing conditions are suitable for seeds intended for human consumption.
Well, consumers always have an important role to play when it comes to preventing food safety problems. In this area we can't rely on consumers to make unsafe sprouts safe to eat. We can't ask them to cook their sprouts. I mean sprouts are natural and fresh and you want to eat them raw. They were intended to be eaten raw. It's unreasonable to ask people to soak them in chlorine, for example, once they get them home and probably wouldn't be very good for them anyway so the onus is on you to really deliver to us a safe product.
If sprout safety cannot be ensured then the industry should use labels to alert high risk consumers to avoid the product.
We recommend that alfalfa seeds should not be used unless they've been produced under conditions which are suitable for human consumption; that FDA should ban the use of mixed batches to aid in traceback; the FDA should encourage the development of safe and natural decontamination methods; the government should provide greater oversight to the sprout industry; and that consumer warning labels should be required until effective controls are identified and fully implemented.
I know this isn't what you want to hear or at least some of it.
So let's talk about it. Let's talk about a couple of these recommendations. The practice of using seeds that have been grown for agricultural use should stop. I know that this is a radical suggestion. I know that implementing this suggestion would have wide implications for the entire industry. However, the outbreak data clearly illustrate the contaminated seed are the primary cause of sprout outbreaks. While farmers can safely use manure on alfalfa grown for agricultural purposes it should be strictly banned in the growth of seeds intended for human consumption. Farms that supply seeds to sprout growers should observe strict guidelines for the growth of these seeds and should exclusively root their seeds towards the production of human food.
In addition, the practice of growing sprouts from seeds imported from other regions of the world should stop unless it has been demonstrated that the seeds have been produced under similar strict guidelines.
The practice of mixed batches of sprout seeds makes traceback nearly impossible. Alfalfa seeds intended for human consumption should be maintained in intact batches that are carried through the food production chain from the farm to the table. The batches of seeds and packages of sprouts should be clearly labeled or tagged for ready identification during a recall or traceback. This will help assure that problem seeds and sprouts are readily identified and may be quickly removed from the market.
The methods currently in use, calcium hypochlorite and chlorine, are primarily reduction steps and not elimination steps. While these methods may eliminate some of the harmful bacterias, others may survive treatment. We recommend that all decontamination methods should be challenge tested with seeds positive for E. coli 0157:H7 which may be more resistant to some treatments than other pathogens. Both FDA and the seed and sprout industry should provide clear and accurate information to consumers on the effectiveness of each of the various decontamination treatment methods.
We think the government should require that all sprout growers be classified as food handlers; that unsanitary conditions in the processing plants can lead to contamination of the seeds or sprouts, particularly because sprouts are grown in a warm moist environment which facilitates bacteria growth along with sprout production.
CSPI recommends regular inspections of sprout processors by both state and federal food safety inspectors. In addition, CSPI believes that implementing a HACCP system for the sprout industry would be an effective tool and should be considered.
Although there is no pasteurization step currently available for sprout processors that would leave the product fit to eat in its natural form, there are possible barriers or multiple hurdles that could be incorporated into a HACCP system.
In response to the foodborne illness outbreaks associated with sprouts, FDA has issued a number of consumer advisories over the past few years so let me tell you where that leaves consumers. We know that's not what--when it happens your sales go down dramatically but where it leaves consumers is this: This relies on consumers' memories of what they might have read or heard in the news to protect themselves. This is a far less effective technique for transmitting consumer information than a label on the container. We believe that labels on sprout containers should alert consumers that the product may not be safe to serve to consumers, immunocompromised or elderly consumers or children.
In previous years FDA has implemented mandatory labels for several high risk foods, including unpasteurized apple cider, that pose a comparable risk to sprouts.
So, in conclusion, CSPI urges FDA to move quickly and expeditiously to start the notice and comment rulemaking process for sprout safety regulations. There have been over two dozen outbreaks linked to sprouts in the past ten years, representing thousands of consumers who became ill. Until effective controls are identified and fully implemented, we believe sprouts should be prominently labeled to alert consumers to the risk of eating sprouts.
I want to make one final note. I was very impressed with the last presentation on actually putting the burden on the people who distribute the seeds to actually test them for the safety and it reminded me of practices in the ground beef industry. When I was working on the Jack in the Box outbreak back in the mid 1990s the beef industry said, "Oh, we can't test the ground beef. We can't test every lot for E. coli 0157:H7. That would be a terrible burden and it wouldn't be effective."
Today many companies in the ground beef industry are testing every lot. They are using test and hold programs and they are accepting that responsibility. I thought the presentation that showed that the people distributing the seeds to you would be willing to accept that responsibility by actually sampling the lots is a very important statement about where we need to be going on this.
Thank you.
DR. BERU: Thank you, Ms. DeWaal.
I would like now to invite the panelists who have spoken thus far to the table for a question and answer session.
If you do have questions, please step up to the microphones as we are recording this meeting. The transcript, as I said, will be available in about four weeks time.
MR. WARRINER: My name is Keith Warriner from the University of Guelph. This is a question for Bob R. You mentioned in your talk about preventing four cases through spent irrigation water testing. Well, there was two cases where they did do all the testing but they did deliver contaminated product to the marketplace. So is this application of no sanitation and just depend on testing really going to be effective?
MR. RUST: I'm sorry. I didn't understand the question.
MR. WARRINER: All right. So we're talking about just testing rather than sanitation and trying to put greater reliance on the testing of seed batches to determine contamination of that batch and you said that saved about four cases of outbreak cases but there was two, wasn't there, that they did all the testing but they still delivered contaminated product to the marketplace.
MR. RUST: Yes.
MR. WARRINER: So do you think your application of just relying on testing will really be adequate?
MR. RUST: Relying on seed sampling and testing, no, it won't be adequate. It's just one step in seed safety, a reduction step.
DR. SMITH: If I can say something, I think the point that you just made is that screening the seed is an additional step above and beyond what we specifically laid out in our guidance and in the instances where contamination is heavy enough that you can catch it at that point, you keep that seed out of the food supply and you avoid some of the outbreaks.
Something else I was thinking of just before we came to the table, the question earlier this morning about seemingly mixed messages from CDC and FDA about the relative importance of seed disinfection treatment versus testing, I think there are a lot of examples where the outbreak investigation shows that seed disinfection had an impact, either on implicated lots used at facilities where seed disinfection programs were not causing illnesses, things like that, or lower numbers of illnesses at least from firms.
But when it comes to testing, the testing of the spent irrigation water at the facility, we have fewer anecdotes from our investigations possibly because the testing caught contaminated product and avoided the outbreak.
On the other hand, even if you're testing--if you're testing the wrong thing or doing it the wrong way, you may have a false negative that lets product through and results in an outbreak. It may be well intentioned but still an error in the application of the test itself or an error in the way that the results from the test are interpreted, and we have a couple of examples of situations where that has happened.
MR. WARRINER: Yes. I'm pretty amazed that with all this testing going on nobody can actually give a figure about how effective testing is and I think people would buy into it more if they knew it was working.
DR. SMITH: It would be nice to know who is testing, how often and how often they find a positive and what they do with product. People are probably afraid to tell us but we'd love to know.
MR. WARRINER: Definitely. Thank you.
DR. BERU: Are there any other questions?
Yes, please?
MR. LALLEY: Good morning. I'm Mike Lalley from Living Foods and a couple of quick questions. One for Ms. DeWaal. You mentioned in your presentation that there were 4,500 cases identified specifically with various food products. Of which I see a whole 27 have been related to the various sprout products.
By my poor mathematics, I come out to some place just less than a half of one percent of all of these particular issues that you've raised which are of concern to all of us are related to sprouts. That seems to me to be a fairly low number and not one to be ignored obviously but, that being said, we're all well aware of the green onion problem in the Pennsylvania and Georgia, I believe, where we had dead bodies littering the streets.
Are we labeling--is your organization proposing that we label each package of green onions with a warning label? It has been shown that apples which have been defecated upon by birds are absolutely impossible to decontaminate. There's just no way.
Now maybe we should suggest to the public let us quit consuming raw apples, cook your apples prior to eating. And these are just the items that have been identified.
Like I say, if the bird defecates on the apple, we don't have a multi-state situation. He may go over on to another tree and his cousin and his brothers, they may be defecating on other apples and so we may have numerous people ill but not able to traceback.
So it just seems to me that we're a little over anxious to attribute these terrible situations to something that is--to an industry that is in a position that's very difficult to defend ourselves.
DR. BERU: Let's give Ms. DeWaal a chance to respond.
MR. LALLEY: A quick response. I'd like to have one other question.
MS. DeWAAL: Thank you very much. I understand the challenge for the industry of addressing the problem just because of the production issues but by my calculation it's--at least in our database it's about 29 outbreaks. And the bottom line is there--it's serious.
If people get E. coli 0157:H7 it can result in hemolytic uremic syndrome. People exposed to Salmonella have other serious complications. So these problems can be addressed and other industries have faced them.
Now unpasteurized apple cider--I mean FDA held meetings just like that to address that issue.
MR. LALLEY: And that contamination came from--the unpasteurized apple cider, the contamination came from apples?
MS. DeWAAL: It's apples.
MR. LALLEY: Maybe we should--are we warning on apples? I mean, if, in fact, if we drew some multitude of apples and are able to put E. coli into the finished product--well, then it's a no brainer that the apples are contaminated. If the apples are contaminated at a level to which we can no longer consume fresh apple cider without having a warning in our faces, where is the--maybe then if I juice my sprouts--I mean, we're--
MS. DeWAAL: This is a process--
MR. LALLEY: I mean, there's just no--yes, but you're ignoring--I mean, just--I mean, is there any--well, just answer the question then.
Is there any specific desire on your organization or FDA or anybody else to warn consumers of the consumption of raw produce, fruits, vegetables, et cetera, which we all know are in a position--are grown in a warm--you know, we have talked about the warm, moist environment in the sprout operations.
I also do a little dirt production myself of culinary earth, which just so happens that it's a warm, moist environment that produces all of the raw fruits and vegetables that we consume. It's not only in our sprout environments so it just seems to me that we're focusing an inadequate or an over abundant amount of attention on this particular group.
MS. DeWAAL: Well, as you saw in my presentation, I did give you the data on all produce because we do focus our efforts there but more importantly, I think to your question, is that you are producing a processed food product and the processing may be something simple and natural that can be done in my home kitchen but nonetheless if you bring your products to the market consumers have an expectation of safety that you need to address and these outbreaks demonstrate that the processing needs to be improved.
MR. LALLEY: Absolutely and we're in total agreement but the question is, is there any desire on your group or the FDA to take this warning label and apply it to all items that may fall into this type of a situation? Items that are consumed raw primarily, fruits and vegetables. Do you have the--does your organization have any of that in process?
MS. DeWAAL: We supported the use of labels also on another raw process food.
MR. LALLEY: Green onions?
MS. DeWAAL: Excuse me. No. Raw--unpasteurized apple cider.
MR. LALLEY: How about green onions? We had dead bodies littering the streets. I mean, no--I mean, it's--like I say, by virtue of the fact that I'm strong and my position in no way reflects the fact that I disbelieve that there's problems, potential problems on any food product, with that being said why the inordinate amount of attention in the complete looking the other way on these other products? I mean, it just seems absolutely ridiculous.
DR. BERU: I think that question has been asked and--
MR. LALLEY: And the answer was we are or we are not considering warning labels on other fruits and vegetables? Yes or no?
DR. BERU: I can tell you the--
MR. LALLEY: It's a yes or no question.
DR. B
