It was back in January of 2007 that we published a piece entitled, Fresh Express Gives $2 Million: But Its Food Safety System May Be a Bigger Gift. In that piece we featured an announcement from Fresh Express:
Fresh Express, the No. 1 producer of value-added salads in North America and an industry leader in food safety, today announced that it will provide up to $2 million to fund rigorous and multidisciplinary research to help the fresh-cut produce industry prevent contamination by the deadly Escherichia coli 0157:H7 pathogen, which has caused numerous outbreaks over the past decade, including the recent occurrence related to fresh spinach. Although no Fresh Express product has ever been shown to have caused an outbreak of food-borne illness, the company is funding — and, in a unique move, will share this research publicly — in recognition of the benefits it may achieve for both the industry and consumers alike.
The funding of the research was important, and pledging to make the results publically available was generous. Yet in some ways, the most intriguing facet of the announcement was a unique public/private independent scientific advisory panel:
An independent scientific advisory panel comprised of six nationally recognized food safety experts from both federal and state food safety-related agencies and academia has been meeting on a nonpaid, voluntary basis since May 2006 to develop the most productive research priorities related to the source, mode of action and life cycle of E. coli 0157:H7 and the pathogenic contamination of lettuce and leafy greens. The panel is chaired by Dr. Michael T. Osterholm, Ph.D., M.P.H. and director of the Center for Infectious Disease Research and Policy, University of Minnesota. In addition, the panel consists of Dr. Jeff Farrar, California Department of Health Services; Dr. Bob Buchanan, U.S. Food and Drug Administration; Dr. Robert Tauxe, U.S. Centers for Disease Control and Prevention; Dr. Bob Gravani, Cornell University; and Dr. Craig Hedberg, University of Minnesota.
By April 2007, we were able to publish Fresh Express Research Grant Is Allocated To Scientists, and Dr. Osterholm expressed his enthusiasm:
“The quality of the proposals was extraordinary,” said Dr. Michael T. Osterholm, Ph.D., M.P.H., director of the University of Minnesota Center for Infectious Disease Research & Policy and the voluntary chairman of the Fresh Express Blue Ribbon Scientific Advisory Panel. “We were all extremely impressed by the innovative approaches and new directions being applied to E. coli O157:H7 research to better understand and ultimately minimize the threat of this pathogen in fresh produce.”
Now we have received word that the results are in, and that Fresh Express is going to host a conference to reveal the findings:
On September 11, 2008, Fresh Express will host a ground-breaking event, and one that fulfills the Fresh Express commitment made broadly to share the findings of its comprehensive research initiative into the contamination of leafy greens by the E. coli 0157:H7 pathogen.
On this date, the findings of the nine E. coli 0157:H7 research projects, funded by Fresh Express at a total cost of $2 million, will be reported for the first time ever. These findings promise to bring important new insights to prevention and mitigation strategies.
Please see the attached agenda which outlines presenters. Among these are members of the Fresh Express Scientific Advisory Panel, chaired by Dr. Michael Osterholm, who guided the research priorities and funding decisions. Members include Dr. Jeff Farrar, California HHS; Dr. Robert Tauxe, CDC; Dr. Robert Buchanan, FDA; Dr. Robert Gravani, Cornell University; Dr. Craig Hedberg, University of Minnesota
Who Will Attend? We are already receiving registrations from a broad range of attendees including regulators and legislators from local state and federal levels and their staffs; growers, harvesters, packers, cooler, and shippers, value-added and commodity produce manufacturers and suppliers; food safety researchers and academic experts; fresh produce senior executives, buyers and QA/technical expert from leading retail and foodservice companies; key industry representatives and trade associations, media and consumer gatekeepers, among others.
Who want to spread the word that the Conference is open to all who wish to attend, space permitting. We have made accommodations with our Conference facility, the Monterey Plaza Hotel and Spa in Monterey California, for the largest meeting rooms available, and will be able to accommodate a large number of Conference participants.
Anyone interested in attending the day-long conference may contact Donna Watkins at 512-848-1698, or email firstname.lastname@example.org, to receive a Registration Form and Conference Agenda.
In addition, special keynote speakers will be announced shortly.
While Fresh Express hopes to accommodate everyone who wishes to attend, space is limited and advanced registrations are requested. Day of registrations will be accommodated only if space permits.
All of the research done for the seminar grew out of the priorities the Scientific Advisory Panel identified:
RESEARCH PRIORITY AREAS
Five research priorities were identified for funding by the voluntary Fresh Express Scientific Advisory Panel. Each research project was expected to address one or more of these priorities.
Of the 65 proposals received, nine research projects were selected independently by the Fresh Express Scientific Advisory Panel, totaling $2 million dollars. The research priorities are:
- Determine the potential for the internalization of Escherichia coli O157:H7 into lettuce and/or tissue spinach during the growth of plants and their subsequent harvesting, cooling, processing and transport/distribution. This work should include the consideration of factors affecting internalization as a function of plant varieties, plant age, growing conditions, plant variety, growing season, method of harvest, etc;
- Identify new mitigation strategies and technologies or significant improvements in existing technologies for improved intervention to reduce the levels/frequency of E. coli O157:H7 and other enteric pathogens both on and in fresh leafy green produce;
- Conduct field studies to identify sources and vectors/vehicles for E. coli O157:H7 in the environment and factors that affect the degree and extent of contamination into the produce (particularly lettuce and spinach) field or processing locations. These studies should consider some or all of the following factors on the risk of contamination of ground-grown leafy green produce: the impact of production field flooding, water source (well, irrigation source) and method of water distribution (furrow, sprinkler or drip irrigation), the role of wild animals present in the fields and the presence of cattle and other agricultural animals in locations near production fields;
- Determine the ability of E. coli 0157:H7 to multiply in the presence of normal background flora during transportation from harvest field to the cooler, while at the cooler, and during transportation either as finished packaged salads or cored product in a low oxygen, high carbon dioxide atmosphere, or in open 20 pound returnable plastic totes in temperature regimes commonly used, as well as, temperatures considered abusive; and
- Determine the ability of E. coli O157:H7 and other enteric pathogens to survive composting processes, including those for “green compost” and leafy green field waste and potential for multiplication of the surviving pathogens in composted materials in the fields under optimal conditions.
The agenda for this conference involves both research presentations and an opportunity to discuss and analyze the meaning and implication of the research:
With this much intellectual firepower all in one place, this event will be unique. We asked Pundit Investigator and Special Projects Editor Mira Slott to find out more:
Science & Quality
Q: Fresh Express has been known for implementing the highest food safety standards. In what ways will the research findings alter Fresh Express’s food safety program?
A: We can’t answer your questions because we have to wait with everyone else for the results. We don’t know what the findings are, but we’re dying to know. When we decided to commit $2 million toward the research a couple of years ago, we wanted the entire process to be completely transparent and independent of Fresh Express.
Q: How was that accomplished?
A: Dr. Michael Osterholm convened his committee of three regulators and two academics. We told them the five areas of focus but didn’t want Fresh Express fingerprints on how the research was conducted and who got money.
The one requirement was to complete it in one year and present results to everyone at the same time — the whole industry, the regulators, legislators, and all interested parties — in an open meeting. We intentionally kept the cost for participation minimal, just $100 to cover meals and other basic expenses. This is all about trying to get the story told.
Q: Does Fresh Express intend to follow the recommendations put forth by the independent team of experts if they are more rigorous and stringent than the program currently in place?
A: What we will have to do is reassess our program once we hear the research results. Then we can answer how we will change or alter our food safety program.
Q: What are the key pieces of information you hope to glean from this research? Are you anticipating any big surprises or discoveries?
A: We do, given the mix of researchers from across the country from various institutions. We are expecting interesting results on how to attack problems, better understanding the risk of internationalization of E. coli 0157:H7 into the tissue of plants, and mitigation strategies, and a big one for us — what is the role of properly composted material? Can it still have a chance of spreading E. coli 0157?
Q: I thought Fresh Express didn’t use composted material in its production. Is this a widely done practice in the industry?
A: We don’t use it now; we’ve been afraid to. I’d say it is commonly used.
Q: What is the government role in this project?
A: Certainly the panel that Dr. Osterholm selected included high level executives from CDC, FDA and California HHS. We think these papers will give government officials things to think about in how to go about regulatory activities.
Q: Are you anticipating the recommendations coming out of this research will influence regulatory actions?
A: This research has been done on a time-sensitive schedule. It will suggest a lot of new work that will need to be done. Since the research results will be public, many in the industry and academia will surely be interested in funding and conducting follow-up research.
Q: When did Fresh Express initiate this research into contamination of leafy greens by the E. coli 0125:H7 pathogen? Wasn’t it prior to the spinach E. coli crisis? If so, the timing showed excellent foresight. [Editor’s note: Fresh Express has a work group that looks to the horizon for innovative solutions. The idea for this comprehensive research approach was originally generated as part of a work group discussion involving Dr. Osterholm and Jim Lugg].
A: We knew long before the crisis came that we had no sound science related to contamination of leafy greens by E. coli 0157:H7, and we needed to get our money on the table to fix that. In early 2006, we started the process. For any company like ours that is public, getting $2 million out of the corporate treasury takes time. The Fresh Express Scientific Advisory Panel was formed in March 06, but back in January 06, we were working on getting money.
Then we began moving with the panel to finalize priorities and the spinach outbreak occurred. By December of 2006, we already had a request for a proposal draft, but we waited till January 07 because we didn’t want it to get caught up during holiday time. Then the panel reviewed all of the proposals; 70 some proposals in all. The request for proposal followed normal university research project protocol; it was disseminated widely through all academia channels and a press release went out to generate interest and spread the word on the research project.
Q: How was the grant money distributed?
A: The scientific advisory panel chose the proposals. At the very outset of this, these five areas to be researched were set. Obviously, we conveyed our issues of concern and discussed them with Dr. Osterholm and he agreed those were the major areas of research that should be pursued.
We never saw any of the proposals until the nine were chosen. Hopefully, after the September 11 conference when all this information becomes public, it will help the regulatory community to think differently; to look to research institutions to help figure out these outbreaks.
Q: Do you believe FDA’s outbreak investigations were hampered without having this spectrum of expertise?
A: We had the same frustration as others in the industry with FDA’s Salmonella Saintpaul investigation. We know so little about what goes on behind scenes; we only see what they release publicly.
I suspect the regulatory community will look at these research results and they will discuss what could be included in regulations and standards-setting bodies. They’ll compare metrics in the Leafy Greens Marketing Agreement with what we find from this research. I expect when you look at the cost of outbreaks, any additional expenses that come about because of this research, it’s all worth it.
Q: Why did Fresh Express choose to pursue this separate food safety research venture, as opposed to working through industry organizations or investing in The Center for Produce Safety encompassing a wider scope?
A: We’ve been asked that question many times — $2 million is a large sum of money. Why didn’t we put it into the Center for Produce Safety? We were passionate for getting something done quickly. If we went through organizations, the process would have gotten bogged down, so we stepped out and did it with our own money. We didn’t see a good opportunity to go a different route at that point. We debated long and hard because we like to be good team players with the industry. This is such a serious issue… we didn’t want to wait.
Q: Do you get concerned that there will be a perception out there that the research is biased because Fresh Express is sponsoring the conference?
A: Our major message is that the conference is open to the public for $100. We don’t want any possibility of a perception that Fresh Express had a unique advantage in this research work. Everyone will have an opportunity to speak to panel members and be a part of the investigation into food safety solutions.
We hope to avoid any appearance of conflict of interest. We are hosting this thing, but as far as influencing any of these projects, we had none. We don’t know the findings. Fresh Express will find out at the exact same time as everyone else on September 11.
Q: Tell us more about the conference format. Will there be an opportunity for attendee feedback and brainstorming based on the findings?
A: The way the conference is laid out, not only will all panel members be attending, each principle investigator will present their own project. In the afternoon, we will wrap up and have a forward-looking dialogue. At the close of the session, this is also a time for networking. [Editor’s note: For those interested in attending, space is limited, so please contact Donna Watkins at 512.848.1698 or email Donna@StratagentCorp.com].
Q: At the close of the conference, what happens next? Could this research approach be expanded and duplicated in other commodities?
A: Do we expect the results will influence our food safety regulations, yes, and yes, we do anticipate making changes to our food safety program. We are passionate about having the newest mitigations, and potentially new technologies could be born out of the findings. I really think this research venture is the first of its kind; these nine projects are a nationwide effort; this model will spawn a lot more research. .
Q: The large, drawn-out Salmonella Saintpaul outbreak and investigation has shaken consumer confidence to the bone and many industry executives believe it will be difficult to fully restore it. Do you still experience residual damage from the spinach E. coli crisis after all this time? Of course, Fresh Express wasn’t even part of the problem, but the nationwide ban spared no one…
A: It’s still lingering. Customers are still concerned about food safety in spinach. Their fears have rubbed off on the packaged salad business, and I don’t think we’re out of the woods with this problem.
There’s an interesting dynamic going on, there are some organizations, such as Community Alliance for Family Farmers (CAFF) comes to mind and Wild Farm Alliance (WFA), fueling the problem. They are continuing to put out newsletters talking about E. coli… this particular association feels this way or that way.
It’s still being discussed quite widely and unfortunately that has a bearing with the consumer at the shelf. We’re still trying to figure out how to get back into the consumer’s heart and mind to understand the safety of product on the shelf. It’s frustrating, to say the least. We’ve made progress but we’re not back to where we were prior to the outbreak. The announcement from the FDA ‘do not eat fresh spinach’ was painted with a broad brush. We’re not critical of FDA’s desire to protect consumers. We would have liked a narrower announcement and a faster resolution.
| Dr. Michael Osterholm
University of Minnesota
Center for Infectious Disease
Research & Policy
Panel Chair, Scientific Advisory Panel
Q: How important is this research?
A: It represents the collective experience and wisdom of the review group in terms of what we believe to be important issues for leafy greens. This is highly targeted research.
We’re exploring a combination of areas that have been under-researched or not researched at all, and that may have been critical in recent outbreaks. The key thing… well there are several important things that have come out of this; the first is that one industry party is stepping up to the plate even when they were not involved in an outbreak. I’ve seen many times where a company puts resources up mea culpa after being part of an outbreak. At Fresh Express we discussed the real need for this research; it’s critical for the safety of leafy greens, and the company put up the money.
None of us on the review group got a penny; we even ran administration as a freebee. We donated all of our time to this, coming together with actual priorities then developing an RFP, then reviewing over 60 proposals submitted and very extensive reviews on those with multiple people, and several telephone meetings prioritizing proposals with specific issues identified and the ability of the group to do the work. Then there was the interactive process with groups to negotiate the final contracts. The money provided from Fresh Express was only divvied out with our authority. And all this work by the advisory panel was done without taking a penny.
Critical to the process, quarterly reports were made to keep up with what was going on. This conference on September 11 is a culmination. It is not enough to fund research. You need to present it and have time for discussion, to understand and put into context what the results mean. That’s what makes this special.
I have to give great credit to the other people in the group; those five people and myself came together and not one of us got a penny. Here are government agents willing to say this is industry, we may need to regulate, but we also understand the critical role of research, and they openly put their time into coming up with solutions.
It’s a very unique model. I’m not aware of any other like this. We’re in times where we have to do these things for the health and safety of the public. Far too often government grant programs or industry-based programs are laborious, taking years to work through the process. We turned these research projects around in weeks; Jeff Farrar in California was remarkable.
Q: Did this expedited research process allow for meaningful results? Will the conference generate groundbreaking solutions?
A: We’ve been following the quarterly reports but a lot of this work is coming to conclusion now; this isn’t meant to be a surprise. It takes time to present this substantial body of research. Often it takes years to hit scientific literature. Therefore, it would be premature to say groundbreaking, but it is clear we have important results here.
When turning information around this quickly, none of us have had a chance to review late-stage results that would occur, and in many cases those are the most meaningful. We’re getting these results almost in real time. They are not massaged for two years for manuscript preparation. We short-circuited the system a lot to make the research possible, the results credible, and the information dissemination wide.
Q: What else would you say to people considering whether to attend?
A: Come to the meeting. All of us are very proud of the model; it can be a really important example of how to move research forward in the future. This research should challenge the rest of the industry to do what Fresh Express has done. This model will work beyond the Fresh Express experience if done properly. The process itself is important. It shows a collaborative industry, government academia partnership and the ability to turnaround important research quickly.
September 11th is not a day of celebration in America. Nor is it one that brings enhanced safety to mind, but with this conference, perhaps there may be a bit of a change… at least for the produce industry.
Science takes time. There is a reason things get peer-reviewed and a reason scientists try to duplicate each other’s findings. This effort has been an important one to try and push progress ahead on some of the key issues we face regarding E. coli and leafy greens, but no scientific inquiry should be judged by its immediate impact. Many times the best research just points the way to better questions.
Fresh Express deserves much credit for funding and organizing this effort. The panel members, Michael Osterholm, Jeff Farrar, Dr. Bob Buchanan, Robert Tauxe, Bob Gravani, and Craig Hedberg deserve many thanks for working pro bono publico in this important effort.
Yet no one company can… or should… carry the burden of the trade’s food safety research. That is why the industry founded The Center for Produce Safety.
Hopefully the results of the Fresh Express-funded research will provide some useful ideas for reassessing the metrics used for the California Leafy Greens Marketing Agreement. Perhaps more important… hopefully this research will provide many clues to help make future research more productive.
Funding that research will be the responsibility of the whole industry, and the Center for Produce Safety is the most likely conduit.
Many thanks to Jim Lugg and Mike Osterholm for filling us in on this exciting conference. You can download a registration form here.