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FDA's Proposed Produce Rule

By Daniel B. Cohen on November 13, 2013

The deadline for comments on the U.S. Food and Drug Administration’s Produce Safety Rule is Nov. 15, 2013. This was probably supposed to be the easiest and most straightforward of the rules to implement the Food Safety Modernization Act (FSMA). It may be that FDA fell into the trap of a well-worn groove in designing the Produce Rule.

There are precedents for their approach from both Democratic and Republican administrations. However, this is the fourth time that manufacturers, processors and larger handlers of produce have attempted to use, or successfully used, food-safety legislation or state power to achieve multiple economic agendas – even when this would seem unnecessary, given their tremendous economic strength in the marketplace. In commenting on one of those attempts, I wrote: “It doesn’t take much time or experience to realize that Democrats act as they have never met a regulation that they didn’t like, and, if the regulation is ineffective, dysfunctional and complicated, they may like it even more. The Republicans claim they have never met a regulation they liked, except in practice, when it is demanded by industry to give a gloss of procedural protection (biotech for example) or provides a barrier to competition protecting the largest companies in the industry from competition.”

My view in this article is a plague on both their corporatist houses. Different strands were contributed for different political reasons, but they were woven into a political, not a science-based, approach, which said that farmers are ultimately responsible for all produce safety problems; therefore, food safety is achieved by telling farmers what to do. Furthermore, that a farm can be treated in exactly the same way as an individual closed-system manufacturing plant, rather than recognizing the reality of farms being open to, and part of, both a larger polluted environment and a natural ecosystem – and often cooperating with other farms in a social agricultural community, or human ecosystem, if you like.

It’s like blaming shellfish harvesters for the pollution entering Puget Sound, as well as the trucker who did not maintain a cold chain, the chain of stores that improperly stored the shellfish and the ill restaurant worker who accidentally contaminated a seafood salad bar. What is more appropriate for regulating shellfish seems to be discourage harvesting during the warmer months (those not spelled with Rs) , or when public health agencies detect concentrations of human pathogens. The three previous attempts to regulate produce, in this manner, were: (1) Use state power.

This includes (a) the Leafy Green Marketing Agreements (first California, then Arizona) under the state equivalents of the 1937 Agricultural Marketing Agreement Act, creating industry-run state agencies under the Departments of Agriculture authorities; (b) the use of the federal law for the single-state (California) production of almonds under a mandatory Marketing Order, with a rule issued by the USDA’s Agricultural Marketing Service, and (c) changing a state law to incorporate food-safety practices for a commodity, which the Florida tomato industry did in 2008.(2) Incorporate a national food-safety enabling section for produce marketing agreements and orders in the Farm Bill. (3) Create a national Federal Leafy Greens Marketing Agreement (or even Order), which is dormant but still pending. We are now on version (4), achieving similar goals under FDA’s proposed Produce Rules as an interpretation of FSMA.

I was often quite naive about some of this. When the California Leafy Green Handlers Marketing Agreement was being implemented, the organizing procedures were being run by the chief counsel for the California Department of Food and Agriculture. He was a won