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Deconstructing FDA

It began with a bang, a shocking, unprecedented request that nobody eat fresh spinach, but it is ending with a muddled whimper. FDA issued a press release, but let us deconstruct some of it here:

FDA is announcing today that all spinach implicated in the current outbreak has traced back to Natural Selection Foods LLC of San Juan Bautista, California.

FDA, the State of California, the Centers for Disease Control and Prevention and the United States Department of Agriculture continue to investigate the cause of the outbreak. This includes continued inspections and sample collection in facilities, the environment and water, as well as studies of animal management, water use and the environment.

That seems a message certain to confuse consumers. We traced it back to one company, but we really have no idea of the cause and the investigation is ongoing.

Although the current outbreak may ultimately trace back to a specific field(s), there has been a long history of E. coli O157:H7 outbreaks involving leafy greens from the central California region. Spinach processed by other manufacturers has not been implicated in this outbreak, however, based on discussions with industry, and given the past E. coli O157:H7 outbreaks, FDA and the State of California expect the industry to develop a comprehensive plan which is designed to minimize the risk of another outbreak due to E. coli O157:H7 in spinach grown in central California. While this plan is under development, FDA and the State of California reiterate our previous concerns and advise firms to review their current operations in light of the agency’s guidance for minimizing microbial food safety hazards.

This makes virtually no sense. A day ago, the situation was so dangerous nobody could eat spinach grown anywhere in the country. Now FDA would like a plan to minimize future outbreaks but the status quo ante is perfectly acceptable for right now. And, by the way, the guilty and the innocent will all be treated the same.

FDA and the State of California have previously expressed serious concern with the continuing outbreaks of foodborne illness associated with the consumption of fresh and fresh-cut lettuce and other leafy greens. After discussions with industry, FDA and the State of California, as part of a longer term strategy, now expect industry to develop a plan to minimize the risk of another outbreak due to E. coli O157:H7 in all leafy greens, including lettuce.

Of course, we had that already. Otherwise we would have outbreaks every day. And what does “minimize” mean. Should we test the water every week? Every day? Every hour? This is not so much regulating the industry or even guiding the industry as much as dreaming or wishing for an outcome.

The Grower Shipper Association of Central California, the Produce Marketing Association, the United Fresh Produce Association, and the Western Growers Association said today, “We are committed to working together as one industry to learn everything we can from this tragedy, and will redouble our efforts to do everything in our power to reduce the potential risk of foodborne illness. As we have in the past, we will work aggressively with the Food and Drug Administration and state regulatory authorities to ensure the industry’s growing and processing practices continue to be based on the very best scientific information available, and that we are doing everything possible to provide the nation with safe and healthy produce.”

The trade associations deserve a lot of credit for working with an FDA that has shown itself to be dysfunctional. The FDA starts out by causing a mass panic and countless damage by putting a de facto ban on spinach consumption when a voluntary recall of one brand or, at the extreme, one processor’s product, would have sufficed. Then the FDA ends up implementing no changes at all to ensure safety or rebuild consumer confidence.

One other very good thing is that the joint statement promises that the industry will do “…everything possible to provide the nation with safe and healthy produce”, which is a far better and more realistic notion than promising safe produce.

Implementation of these plans will be voluntary, but FDA and the State of California are not excluding the possibility of regulatory requirements in the future.

Voluntary implementation is what the industry has always wanted, but I am starting to find it difficult to believe that this will hold. We need, as an industry, to reexamine the point. Tom Nassif of Western Growers Association, raises a valid point about holding foreign producers to the same high food safety standard, but it is difficult to hold foreign producers to voluntary standards. The current outbreak also teaches us, very clearly, that the whole industry can be destroyed by one sub-standard operator. Do we really trust each other so much that we are comfortable relying on people voluntarily doing the right thing?

FDA will be holding a public meeting to address the larger issue of foodborne illness linked to leafy greens later in the year once the current investigation is complete.

Obviously our growers, trade associations and political friends convinced the FDA to not destroy an industry while it waited for final results. But the industry will be fighting this battle for a long time to come.

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