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FDA Indicates Guarded Willingness To Regulate Produce

Several articles, including this one entitled FDA Stymied In Push to Boost Safety of Produce, which ran in The Wall Street Journal, claim that February of this year, the FDA proposed a substantial regulatory regime for fresh produce, but higher-ups at the Department of Health and Human Services rejected the plan:

The Food and Drug Administration, under fire for a string of illnesses caused by contaminated vegetables, earlier this year came up with an ambitious, industry-endorsed plan calling for tough new regulations on the handling of fresh produce.

But the plan went nowhere after it got a cold reception from FDA’s parent agency, the Department of Health and Human Services. And even today, amid continuing concern about the safety of the nation’s food supply, efforts to address the problem remain in limbo.

people close to the FDA say HHS officials led by acting Deputy Secretary Eric Hargan rejected the FDA plan, which was presented in February at HHS headquarters. At the meeting, the FDA warned that its current approach to protecting the safety of fruits and vegetables, which relies on the industry following voluntary guidelines, was failing to stop an increase in foodborne illnesses, according to people familiar with the matter. Those in attendance included Robert Brackett, director of the FDA’s Center for Food Safety and Applied Nutrition.

Among other things, the FDA outlined a three-year effort that would pump $76 million into its coffers to monitor produce safety and impose stringent rules on growers and processors to prevent contamination. Such a campaign could cut produce-related outbreaks of illness in half, the FDA officials said.

Spokesmen for the Department of Health and Human Services say the meeting is being correctly characterized:

HHS spokeswoman Christina Pearson said that the February meeting was just a background session, with the FDA presenting ‘a wide variety of options available to us in our efforts to improve food safety,’ and didn’t require a policy or regulatory decision.

In any case the regulations being proposed didn’t seem to conform to what United Fresh had in mind in its call for Federal regulation, which we discussed here:

A preventive-control regulation, the type proposed by the FDA at the February meeting, is tailored to each industry and company, and the government’s cost stems mainly from auditing companies for compliance. For example, a processor would identify the hazards and take measures to reduce them at critical points, such as ensuring the correct chlorine level in washing water.

This seems to imply that everyone will have to prepare a HACCP plan and the government will audit it. That almost seems to be avoiding the issue. Natural Selection Foods and Ready Pac both had HACCP plans, and they were audited. Isn’t the real question a substantive one of what should be in the HACCP plan?

And isn’t FDA providing an answer to that question the key way FDA can help the industry?

The article is interesting because it is the first hint that FDA might actually be interested in regulating the produce industry. The approach, however, that the article says the FDA proposed, implies that FDA will not put itself in a position of promulgating a regulation that could then be found faulty.

In other words in our discussions with growers, what they really want is clear rules. They want the FDA to say that a field must be fenced with a wire mesh fence with an aperture of no more than 2 inches extending underground for two feet and in the air for six feet.

The growers want this so that if there is another outbreak, the growers can point to the FDA and say “We did what we were told.”

The FDA is signaling that it will never regulate with a sufficient degree of specificity to let anyone say that it is the FDA’s fault we had an outbreak.

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