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Perishable Pundit
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Produce Business

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American Food & Ag Exporter

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Center For Produce Safety Established:
An Act Of Faith In The Future

When so much happens in a very short time as it has with the spinach/E. coli 0157:H7 situation and its aftermath, it is sometimes hard to distinguish between what is ephemeral and what carries true significance.

A thousand generations hence, when the spinach crisis of 2006 is not even a memory, one institution is likely to stand, in silent tribute to those who died and as a living memorial to the spirit of the men and women who lived in our age, who worked in our industry and who rose to the occasion by, in a moment of uncertainty and despair, refusing to give in and refusing to accept that there was no solution.

Mark Roh, Acting Regional Food and Drug Director for the Pacific Region, United States Food and Drug Administration; Dr. Kevin Reilly, Deputy Director of the Prevention Services Division for the California Department of Health Services; A.G. Kawamura, Secretary, California Department of Food and Agriculture; Bryan Silbermann, President, PMA; Jeff Farrar, Chief of the Food and Drug Branch of the California Department of Health Services

That institution is the Center for Produce Safety at the University of California, Davis campus. The Center is headquartered within the Western Institute for Food Safety and Security at UC Davis. It was launched with all kinds of luminaries from industry, government and academia present and was made possible by initial pledges of $2 million from the Produce Marketing Association. Taylor Farms contributed $2 million in cash and another million in research already planned by the company. The State of California contributed half a million dollars, UC Davis $150,000 and more money is expected soon.

Drew McDonald, VP Quality Systems, Taylor Farms; Bryan Silbermann, President, PMA; A.G. Kawamura, Secretary, California Department of Food and Agriculture; Bennie Osborn, Dean, UCDavis School of Veterinary Medicine

The establishment of such an institution is of no small import. For it represents a life view that we as an industry, that humans as species, are not condemned to merely endure the trials of life but that by harnessing the human intellect with disciplined work we can, in fact, prevail against the obstacles before us.

In this sense this Institute is not so much about E. coli or spinach, it is about the attributes that make us distinctively human.

Bruce Taylor, Chairman and CEO of Taylor Farms, Chairman-elect of the Produce Marketing Association, has during this crisis been thrust the mantle of leadership. So many fresh-cut processors were either implicated in the problems or were not Salinas-based companies, so this son of the Salinas valley, this scion of a family whose name looms large in the heritage of our industry, has been asked to carry water for a whole valley, for a whole industry.

And now, after he did all that was asked, he rallies his company, he risks his treasure, and inspires his fellow PMA board members to do even more.

Drew McDonald, VP Quality Systems, Taylor Farms; Tim York, Chief Executive Officer, Markon Group and former Chairman of the PMA Board of Directors; Bryan Silbermann, President, PMA

Bryan Silbermann, President of the Produce Marketing Association, an immigrant to America, an adopted son of this land, somehow knows that the time for small concerns is past. The ratios and balances taught to Certified Association Executives must be put aside. For months, graciously, he has let others take the lead. Yet somehow, some way, this is the moment, and this son of Africa, scion of those who walked in Solomon’s Temple, is a part of building in his adopted homeland an institution that will stand forever.

Each board member of PMA must be saluted, as each put aside parochial concerns, for the common good of the trade:

Name Company Position
Peter Goulet Pinnacle Sales & Marketing, Inc. Chairman of Board
Janet Erickson Del Taco LLC Chairman of Executive Committee
Bruce Taylor Taylor Farms, Inc. Chairman Elect
David Corsi Wegmans Food & Pharmacy, Inc. Secretary/Treasurer
John Anderson The Oppenheimer Group
Anthony Barbieri Acme Markets,Inc.
Leonard Batti NewStar Fresh Foods, LLC
Pablo Borquez Campo Pablo Borquez, SA de CV.
Craig Carlson Pathmark Stores, Inc.
Mike Cavallero Dole Fresh Fruit Co.
Daniel Crimmins University of Notre Dame
Margaret D’Arrigo-Martin D’Arrigo Brothers of California
David Gill Gills Onions
Don Harris Wild Oats Markets, Inc.
Michael Maxwell Procacci Brothers Sales Corp.
John McGuigan Sunkist Growers, Inc.
Lisa M. McNeece Grimmway Farms
Terrence M. Murphy Paganini Foods, LLC
Michael O’Brien Schnuck Markets, Inc.
Jeff Patterson BJ’s Wholesale Club, Inc.
Chris Puentes Interfresh, Inc.
Timothy Riley Giumarra Companies
Rob Robson OneHarvest
Andrew Sharp Mack Multiples
Michael Spinazzola Diversified Restaurant Systems
Stephen Tursi Wal-Mart Stores, Inc.
Mikel R. Weber Golden Corral Corporation

This triumph, though, belongs not to any one man or one association or one company, it belongs to an industry that, separated by different products, different geographies and different segments, came together when the chips were down to find a new path to success.

Rob Atwill, Interim Director, Western Institute for Food Safety and Security; Bryan Silbermann, President, PMA; Linda Harris, Associate Director of Research, Western Institute for Food Safety and Security

The race is not run, success may not be certain, E.coli may long be a problem, but let the record show that in Davis, California, on the 11th of April, 2007, the produce industry expressed its faith in the human intellect and imagination as the root from which solutions to our problems can spring.

And as the members of this industry know better than most, great oaks really do grow from little acorns.

Here is the way PMA described the event:

PRODUCE INDUSTRY LEADERS LAUNCH
CENTER FOR PRODUCE SAFETY AT UC DAVIS

produce Marketing Association Pledges $2 Million to Establish Center and Fund Scientific Studies Designed to Improve Food Safety; Taylor Farms Matches Cash Donation

DAVIS, Calif. (April 11, 2007) — Representatives from the country’s leading produce trade associations and Calif. Dept. of Food and Agriculture Secretary A.G. Kawamura today announced plans to create a Center for Produce Safety at the University of California, Davis. The Center will be housed at UC Davis’ Western Institute for Food Safety and Security (WIFSS), whose mission is to conduct research that enhances the safety and security of the nation’s food supply. The Produce Marketing Association (PMA) is contributing $2 million to establish the Center. Taylor Farms of Salinas, Calif. has also pledged to contribute an additional $2 million in cash as well another $1 million of research already planned by the company. PMA will work with the State of Calif., which also is contributing $500,000, and other leading industry association to secure additional funding for research and training initiatives.

“I commend the produce industry and the Western Institute for Food Safety and Security for collaborating with government to launch the new Center for Produce Safety at the University of California at Davis,” said California Secretary of Agriculture A.G. Kawamura. “The Center for Produce Safety will lose no time putting together an aggressive research, training, and outreach agenda into how and where food borne illnesses arise in produce, and actions that can be taken to reduce these risks. The industry’s actions will help restore consumer confidence and demonstrate that the health and safety of consumers is their ultimate priority.”

“The success of the produce industry depends on our collective commitment to public health,” said PMA President Bryan Silbermann. “Our members, who represent every link of the nation’s produce supply chain, are committed to supporting robust food safety programs based on the best science available. The Center for Produce Safety will significantly advance the entire industry’s collective knowledge about food safety and help ensure consumers continue to enjoy safe, wholesome and healthy produce, every bite, every time.”

Bruce Taylor, Chairman and CEO of Taylor Farms agreed, noting, “I consider the contribution Taylor Farms is making today as an investment in the future of our company and the produce industry. I encourage my colleagues across the entire supply chain to contribute at whatever level possible to ensure that the Center for Produce Safety is able to advance an aggressive research agenda that provides produce companies with the guidance needed to further enhance food safety efforts.”

The Center for Produce Safety will primarily focus on two critical objectives. First, it will serve as an unprecedented clearinghouse for all available research related to produce safety. This initiative is the first in the industry designed to capture all existing scientific data on food safety in one central repository. Second, the Center will fund new scientific studies focused on developing new solutions that mitigate risks associated with the nation’s produce supply. Allocation of the Center’s research investments and oversight of active research projects will be led by a governing body consisting of leaders from industry, associations, government and academia. Details of this body are currently under development.

RESEARCH INITIATIVE PART OF COMPREHENSIVE
INDUSTRY RESPONSE TO IMPROVING PRODUCE SAFETY

The creation of the Center for Produce Safety is the direct result of an industry-wide collaborative response to recent E. Coli outbreaks. In the fall of 2006, the Produce Marketing Association, other industry association partners and government agencies focused on investigating the cause of the outbreaks and expediting efforts to protect against the risks of future outbreaks.

In addition to the investments in new research, produce industry leaders and food safety experts from the State of California are also launching science-based training and outreach programs. The field-level training support will supplement programs already in place by individual produce growers and handlers and ensure they include the latest scientific information and established good agricultural practices.

The Center for Produce Safety and enhanced field level training and outreach programs supplement the industry’s recent progress in establishing a comprehensive set of new guidelines agreed to by the spinach and leafy greens industry.

Here is the official announcement from UC Davis.

Here is the announcement from Secretary Kawamura and this is Governor Arnold Schwarzenegger’s letter of support.




Ready Pac/Bayside Deal Leaves One Wondering What Happened To Univeg

One of the wackiest deals in the produce industry keeps getting wackier. After months of on-again, off-again negotiations, Univeg announced back at Fruit Logistica in Berlin that it had signed a letter of intent to buy Ready Pac, an event we analyzed here.

It was always a unusual situation. Typically these types of announcements are made jointly but Ready Pac was stone silent for weeks. We actually sat on the story for a week until we could find someone from Ready Pac to confirm the letter of intent existed.

Now Ready Pac issues a statement without mentioning the Letter of Intent or Univeg and says it has received an investment from a private equity firm named Bayside Capital:

READY PAC FOODS, INC.
ANNOUNCES INVESTMENT
BY BAYSIDE CAPITAL

 

Irwindale, CA (April 10, 2007) — Ready Pac Foods, Inc. (“Ready Pac” or the “Company”) announced today that it has received a strategic investment from Bayside Capital, a leading private equity firm. Ready Pac is an industry-recognized innovator of fresh-cut produce and fresh prepared foods with facilities located throughout the United States. The Company has been delivering the highest quality packaged salad, fruits and vegetables for over 30 years. Terms of the transaction were not disclosed.

Ready Pac Chairman and CEO Dennis Gertmenian commented, “We are excited to partner with a premier private equity firm to help facilitate our growth. Bayside’s investment allows us to accelerate our 38-year history of partnering with our customers to bring high quality innovative new products to market while providing excellent service.

“Bayside views our investment in Ready Pac as a flagship investment in the fast growing fresh prepared foods industry segment. We will leverage our financial resources to enhance the company’s operational excellence and industry leadership,” said Tiffany Kosch of Bayside Capital. “The Company has an outstanding management team, leading market position and, with our resources, is well-positioned to capitalize on the many opportunities created by the strong customer demand for its products,” added Anthony DiSimone of Bayside Capital.

ABOUT BAYSIDE CAPITAL

Bayside Capital is an affiliate of H.I.G. Capital, a leading private equity investment firm specializing in acquisitions and recapitalizations of middle market businesses. Based in Miami, Florida, and with offices in Atlanta, Boston, and San Francisco, the firm is one of the most active private equity investors in small and medium-sized companies. H.I.G. manages in excess of $3 billion of committed equity capital to support its investment activities.

We wanted to find out more, so we asked Mira Slott, Pundit Investigator and Special Projects Editor, to get clarification:

Craig Delaney
Executive Vice President-Chief Financial Officer
Ready Pac Foods

Q: How does the strategic investment from Bayside Capital impact Univeg’s and Ready Pac’s signed letter of intent to enter into a business transaction?

A: We did enter into a non-binding agreement with Univeg back in December. At the same time, a number of different companies were interested in investing in Ready Pac. As we continued to explore options, we decided the best option was with Bayside Capital.

Q: Does this end the Univeg deal or could this be a prerequisite to a further deal with Univeg?

A: We were impressed with the Univeg proposal. We chose Bayside Capital to deal with versus Univeg. However, Univeg is a large international company. Potentially down the road, we could do business transactions with them.

Q: So to be clear, Ready Pac will not be pursuing an additional deal with Univeg?

A: The Bayside investment is a replacement deal. We chose Bayside instead of Univeg. I will caveat that by saying that is what I know.

Q: Negotiations with Univeg seemed to reach a standstill during the time period when Ready Pac was being impacted by Taco Bell’s food safety issues. Did this play a factor in the decision-making process?

A: The further in the distance these industry challenges go, the more positive the outcome for Ready Pac. A number of companies expressed interest in strategic investments with Ready Pac, and Univeg was one of them. We’re moving forward with the Bayside Capital transaction, the deal is basically finished. Bayside Capital has every intent of making this a long-term transaction and so does Ready Pac. We are putting all this behind us and focusing on growing our business.

Bayside Capital is not just any private equity fund. As its web site explains:

Bayside specializes in assisting companies to overcome financial or operational challenges. We have extensive experience in out-of-court restructurings, plans of reorganization, bankruptcy sales, DIP financings and related transactions.

In fact, Ready Pac should be able to get more business from at least one customer as Bayside also has an investment in another turn-around play, Marsh Supermarkets.

Just as it was odd for Ready Pac not to mention the letter of intent with Univeg in its announcement, it is equally odd that Univeg hasn’t said a word publicly, even keeping the LOI announcement on its web site.

Normally one would expect a joint announcement that the LOI had been terminated by mutual agreement.

The fact that this hasn’t happened may mean nothing or may mean that Univeg disagrees with Craig Delaney’s assessment that the LOI was non-binding. Which means there could be litigation.

Also, despite Mr. Delaney’s characterization of the Bayside investment as “long term,” the Pundit has never met a private equity fund whose favorite holding time is not two seconds. Perhaps Univeg, with a strategic interest in Ready Pac, still hopes to acquire or partner with the now-recapitalized Ready Pac.

What is clear is that Ready Pac, however its ownership shakes out, is likely to have the resources to be a competitor in the capital-intensive fresh-cut sector.

The Pundit thinks Ready Pac should be looking at our piece, Boskovich Sues Taco Bell. Ready Pac wasn’t treated much better, and Taco Bell’s actions implied there was some fault by Ready Pac. Very possibly this deal, or a better one, could have closed months ago without Taco Bell’s actions. There may be some real liability there.

In any case, let us all welcome Bayside Capital to the produce industry. As they will learn, it is an exciting business.




Guest Pundit: Traceability — A Forgotten Piece Of Food Safety

Here at the Pundit we’ve paid close attention to issues surrounding traceability. To help with understanding this complex issue, we have asked Gary Fleming, Vice President, Industry Technology and Standards for the Produce Marketing Association, to contribute to industry understanding on this important issue.

First, in Guest Pundit — Traceability And the Need For A Common Language, Gary explained the crucial role that data standards play in any industry-wide effort to establish trace-back capability. Then, in Guest Pundit — Pairing The Global Language With Technology, he helped us understand how we could actually make this happen.

Gary has been kind enough to bring us another Guest Pundit focused on some findings he made during a trip to Argentina. It comes as a shock to most Americans, but quite often shippers in other countries are ahead of many U.S. shippers because these shippers often have to meet stringent requirements in order to be able to export. Here is Gary’s take on what he found to be a practical traceability system used in Argentina:

Gary Fleming
Vice President,
Industry Technology and Standards
Produce Marketing Association

I do not believe I need to take a poll of the produce industry to determine what the “hot button” for this industry currently is: food safety. What seems to be forgotten, however, is that food safety has two primary pieces: food-borne illness prevention and traceability. A lot of attention and money has rightfully been on the prevention side. Also important is the ability to trace product movement in a manner that can limit the scope of a food-safety problem.

When PMA and CPMA created a best practices document on traceability more than two years ago, participants of the pilot initially thought that they had an effective traceability system. However, a key finding of the pilot showed that while they had something efficient within their own four walls, the system broke down when it left their facilities. In order for traceability to work effectively, we need the ability to quickly identify the product, locate the source, determine the amount of implicated product, determine which shipments contained the implicated product, and get notice to those who received the implicated product — all within hours.

Many companies in our industry claim to be able to trace product, but can it be done as quickly and as thoroughly as necessary? I believe the case has already been made in our industry to strongly urge companies to have a traceability system that allows for a rapid recall. I also believe every company would like to narrow the implicated product to “cases of products” versus “shipments of products” or total product recalls.

I recently took a trip to Argentina to visit several companies that use a solution which meets a loose definition of “effective traceability.” I was admittedly apprehensive due to the number of phone calls I have received since the E. coli spinach crisis from vendors claiming to have an effective traceability system. Nonetheless, when one particular vendor contacted me, their approach seemed more practical than others I had heard about and seemed to be compatible with the systems of most growers/shippers. Off to Buenos Aires, Argentina, I went.

During my trip, I visited two growers/shippers/packers, five pack houses, one laboratory, and one government agency (I also managed to eat in classic Argentine style every night after 10 p.m., which is considered to be an early dinner to Argentines). One grower, EXPOFRUT, primarily grows and packs apples, pears, onions, grapes and citrus. The other grower, Kleppe, primarily grows and packs apples and pears. While not dependent on advanced technologies, both operations used the same vendor. The vendor, FQ Code, incorporates the use of both barcodes and, surprisingly enough, RFID, along with some paper-based processes where electricity is not available in the fields. This is just one example of how effective traceability can work.

As is normal for most growers, lot and field information is recorded on paper, along with packing crew, pick date and other information. Once the truck carrying the bins arrives at the yard, this information is keyed into a system. Barcodes with unique serial numbers are then printed and placed on each bin. Meanwhile, the keyed information along with the associated barcode number is sent to the packing house. Once the product arrives to be washed, a barcode is read. Product is then verified and dumped into the wash cycle. The information retrieved from the barcode being read notifies the system that product from a specific lot and field has now entered the wash cycle and not mixed with other lots.

The product moves through the wash cycle and then through sizing and sorting lanes. After the fruit is sized, it moves through the process to individual packing lines. Once the product reaches the packer, the system automatically knows the lot and field number from which the product originated. Packers wear badges around their necks that are embedded with an RFID tag. The packer moves by the RFID reader to let the system know that he/she will be packing product arriving from the lot and field number currently in the system. Once the packer packs a case of the product, a barcode is printed and affixed to the case.

The barcode now has information on not only where the product came from, but when it was packed and by whom it was packed. Consequently, in both operations, this process also helps manage productivity of each packer. Once the case arrives at the end of the process and is stacked on a pallet, the barcodes on each case are read and linked to a pallet number. Once the pallet is completed, a barcode is printed and affixed to the pallet that uniquely identifies that pallet and each and every case on that pallet.

Now that we understand the process, let’s look at what they are able to do. The information captured by case and by pallet is made available via the web. Once logged onto the web, one can reference the number on the case which is a combination of a GTIN and a serial number (the very same premise used by RFID for tracking). This number is entered into the system and immediately locates the number of cases packed on the same date, from the same field, from the same lot, from the same packing lane, and from the same packer. This helps the grower/packer narrow the possible areas of infection and quarantine these areas. It will also immediately alert the grower/packer as to who shipped the product and when it was shipped. All of this can be done in a matter of minutes.

True traceability is the accurate generation and recording of a product’s history, including all processes that transport or transform it. This includes not only routine movement like packing, but the mixing of lots, re-palletizing of cases, and even products combined in food preparation. It is used not only in growing and packing but in the distribution end as well, where cases can be reconfigured to form pallets (an activity where most traceability systems break down). The application mentioned above captures and maintains that data in the form of unique serial numbers which enables a rapid pinpointing of an affected product in case of a recall.

FQ Code’s process has been in place for several years at both operations. One recall was narrowed to only 13 cases of product, versus over 70 bins of product normally harvested from that particular field. It took the cooperation of the Argentine government, an appointed group (FunBaPa), industry and FQ Code to figure this out, but for them, it has not only assured an effective, rapid traceability system, but was the answer to a major roadblock from exporting their fruit to Brazil. In 2002, Argentine exporters of fruit to Brazil were suddenly closed out of that market due to product infestation. This led to the development and adoption of rigorous traceability standards of the type now in existence in Argentina. These standards have become instrumental in Argentina’s exports to both Brazil and Europe. Since that time as well, government and industry have cooperated to develop and administer traceability standards. FunBaPa administers those standards.

The lesson learned for the industry is that we must be certain that when we claim to have a traceability system, that the “system” can be used by the entire industry. This naturally begs for standards, which is the cornerstone for identifying products. How can we expect to have a fast, effective traceability system when we all have a different number used to identify the case in question?

Let’s take a simple lesson from the packaged goods industry. They have a number on a product, called a UPC. When anyone needs to reference that item, they look at the number on the product and call the supplier. It really can be that simple in produce as well. We have the standards available. We have the technologies available. We just have to begin using them.

The Pundit had the opportunity to learn a little about this system as FQ Code exhibited at Fruit Logistica in Germany right next to PerishablePundit.com. It was an impressive system because it was practical and didn’t rely on idiosyncratic standards. Gary’s first-hand experience in Argentina adds a lot of weight to the idea that companies should be looking into this system.

It is more than worth spending a few minutes exploring their web site right here. Click on the flag of the country you work out of and learn more about how the system works.

The Pundit, like PMA, gets plenty of calls from people claiming to have traceability systems that can help the industry. Most, however, are impractical or require that everyone buy into a particular producer’s proprietary system. This one seems to avoid these pitfalls.

Normally PMA — and the Pundit — would avoid drawing attention to any particular private system. However traceability is an important component of a food safety system, and we urgently need to move ahead in this area.

We need systems, as Gary explains, that can be used by the whole industry. Maybe other existing systems can do this as well and maybe others will create new systems that can do it. But this system, here now and functioning in Argentina, is certainly a fine place to start.

Many thanks to Gary and to PMA for the legwork in Argentina and for sharing these thoughts with us today.




Pundit’s Mailbag — Two Windows And Two Issues

Our piece, California Marketing Board Accepts GAP Metrics, brought an interesting response:

The two best websites discussing e. coli and spinach that I found, without previous knowledge of them, are Bill Marler and the Perishable Pundit. I testified at the USDA hearing in Oakland on two risk issues not under grower control: lack of medical treatment for HUS [ Hemolytic Uremic Syndrome and reservoirs of O157, particularly in cattle. Thank you for at least printing comments about the third issue: lack of standard food safety procedures in processing plants.

There were about four minutes of union testimony at one of the Florez hearings (joint ag comm’s, Feb 2007): also didn’t impress one about all processors commitment to food safety in work rules.

In your March 28 article you said:

“We need to start working on new GAPs for next season. We were fortunate this year and weren’t pilloried for WGA’s secret panel. We shouldn’t count on such good fortune next year.”

The industry has two narrow windows of begrudging tolerance from the wider public.

The first window is between the Agreement and the rest of CDFA’s program. CDFA has stated the Agreement is the first step in a four-stage program: California Agreement (handlers, voluntary), California Market Order (growers, mandatory) to be followed by a Federal Agreement and the Federal Market Order. Once CDFA moves to the Order, the resistance starts going nuclear because of (a) perceived environmental impact of the metrics on farms [and of the processor’s agent’s ratings of farms] and (b) corporate control of the board over every farmer who grows components of salads. That window started closing as soon as the board became effective.

The second window is from now to the first outbreak/recall with the board in place. Maybe more tolerance because full implementation takes time.

— Dan Cohen
Maccabee Seed Company
Davis, CA

We appreciate Dan’s kind words about the Pundit, and we are sure Bill Marler, the noted plaintiff’s attorney in food borne illness cases, thanks him as well.

What makes this letter interesting is Dan’s raising of two issues that are not often talked about in this context:

First, he raises the issue of investing money on research and treatment related to Hemolytic Uremic Syndrome — this is what typically kills or causes permanent damage as a result of E. coli 0157:H7.

Of course, we have been focused on reducing the incidence of outbreaks, but Dan is suggesting an additional approach. After all, if the worst thing that happened from E.coli 0157:H7 was a stomach ache, nobody would be very concerned.

In his written testimony submitted for FDA hearing in Oakland he elaborated:

Let’s begin by discussing informal interviews with law firm principals who have, in total, won over $300 million in O157 lawsuits; I asked them about the % of settlements and the perceived damage to clients due to HUS.

As an example: one firm, with 14 years experience with O157, represented about 200 HUS cases out of over 1000 settled or litigated cases. The non-HUS cases minimally included an ER visit and an illness of over one to two weeks.

Looking at both jury trials and settlements without trial, when HUS is present, collected damages range from a minimum of $500,000 to a maximum of over $15 million per patient. The amount depends on the severity of damage and the long term diagnosis of care that will be required.

Monetarily HUS dwarfs other settlements; HUS represents 85 to 90% of total compensation, despite being less than 20% of total litigated cases.

In their view, this is because the devastation of patients over their compromised lifetimes, or their death, due to hemolytic uremia syndrome dwarfs all other medical harms due to O157.

Improvement in medical care over the last 14 years has led to increased survival rates but no improvement in prevention of damage due to HUS.

Their experiences mirror and quantify the concerns I first heard expressed in conversations with case investigators from the Centers for Disease Control, following the apple cider and Odwalla cases: when O157 cases elaborate into HUS the symptoms can be horrible and the results can be devastating…

In my view, the FDA should lead an interagency working group covering all aspects of contamination and outbreaks including therapeutics. This should include special funding and research on HUS therapies.

[The only therapeutic I know of entering phase II clinical trials is a (monoclonal antibody) mAb combination antitoxin; research originally done at the Uniformed Services University, sublicensed and now controlled by a biotech company in Canada; it has Orphan Drug status in the US and EU.]

For the leafy green and salad industries, better therapeutics for HUS would mean that growers, handlers and consumers would be exposed to the risk of a greatly reduced harm.

Basically what Dan is saying is that we should act both to reduce the frequency of outbreaks and also to reduce the impact of an outbreak when it does occur.

The way we reduce the impact of an outbreak is by developing better treatments for HUS.

The industry is loathe to even discuss this because it might be seen to imply that we intend to continue to have outbreaks. But realistic people understand that even with a concerted effort, outbreaks may happen.

A parallel effort to find better treatments for HUS makes perfect sense.

And because so few people are affected by HUS each year, it qualifies as an “orphan drug,” which gives drug companies an extended patent and certain other benefits if they develop treatments. It would be a wise idea to work with the National Kidney Foundation to set up a dedicated fund to support research in this area.

It would both be a generous act to help victims of HUS and thus of produce industry E. coli 0157:H7 outbreaks and an act of enlightened self interest, as reducing the long term impact of HUS would reduce the liability of the industry in the case of an outbreak.

Dan’s other point focuses on the dangers of production practices with regard to meat or dairy:

The FDA-led working group should also conduct a complete review of off-site health dangers posed by practices in the production of meat and milk in the cattle and dairy industries. Cattle and dairy have been repeatedly identified as the principal reservoir of O157 and other shiga toxin E. coli strains of concern. They have also been reported to be important origins and reservoirs of multiple antibiotic resistances of concern to human health. Both reservoirs should be identified and reduced.

He also provided a supplemental written response to FDA Panel member Shirley Bohm, Consumer Safety Officer, Office of Food Safety, CFSAN FDA, in response to her question on this matter, and you can find that response here.

Much of Dan’s focus here is on what can be done to reduce E. coli 0157:H7 prevalence in cattle:

“….identifies feedlot practices as a contributing factor to O157 prevalence, without being able to conclude which practices are determining….

…targeting just 5% of the most infectious individuals, by itself, could significantly decrease transmission of O157 within herds. They also suggested measures for dramatic reductions in prevalence or transmission. Taken together, these suggest that identifying changes in feedlot practices and selectively controlling the most infectious animals could greatly reduce cattle as a source reservoir.”

Here at the Pundit, we ran a piece entitled, Pundit’s Mailbag — Eliminating E. coli 0157:H7, which expressed our puzzlement as to why produce growers should be obligated to maintain distances from cattle, when it seemed cattle ranchers and dairy herd managers ought to be obligated to keep the pollutants their animals produce on their own property.

This is an area well worth exploring by our trade association government relations people.

We are not as certain as Dan as to what the next step will be or when it will be taken. With virtually complete participation in the California Marketing Agreement, the priority may be to move it on to Arizona more than to make it mandatory.

We do agree that tying the industry together in the dramatic fashion of the California Marketing Agreement will make another outbreak more than problematic.

Dan also mentions one of the key issues that will become more pronounced as memories of the spinach outbreak fade. As long as people are actively dying and getting sick there will be political support for clear-cutting riparian areas to avoid creating or allowing animal habitats.

But the environmental movement is very strong, especially in California, and they will fight clearing out areas near rivers and what not. They want natural vegetation and wildlife in these areas. We’ve discussed this issue in many places, including Food Safety Concerns Clash With Organic Values, and Dan’s letter warns us that mandatory regulation,which would cover every little organic grower, will see that the resistance starts going nuclear because of (a) perceived environmental impact of the metrics on farms [and of the processor’s agents ratings of farms] and (b) corporate control of the board over every farmer who grows components of salads.”

Battles do lie ahead. Something to think about: Dan got involved in the whole spinach matter because he is very involved in plant genetics and breeding, including specialty crucifers for salad or stir fry mixes. If the standards only affected those selling to fresh-cut processors, he might not have been so involved. It is the impact on many small growers that has him particularly concerned.

Many thanks to Dan for his thought-provoking letter.

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