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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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