One of the more interesting and frank discussions at the United Fresh Washington Public Policy Conference occurred during the Oct. 5 meeting with FDA officials in College Park, Md.
The gist of the discussion was this: the FDA is moving away from the designation of particular commodities as "high risk" as they write the pending produce safety rule. Instead, they are looking at particular agronomic practices - application of manure to produce field, direct application of agricultural water to the edible portion of the plant - rather than considering the risk profile of the commodity alone.
Not all industry members are pleased about the approach. Joel Nelsen, president of California Citrus Mutual, questioned FDA officials how crops like tree fruit and vine crops - historically untouched by foodborne illness outbreaks - should be subject to the same regulatory burden as commodities that have grabbed headlines with foodborne illness outbreaks.
Don Kraemer, acting deputy director of operations for FDA’s Center for Food Safety and Applied Nutrition, described what he called “the current thinking of the agency."
“The extent of the standards and controls in the rule varies according to the risk of the agronomic practice,” he said. For example, he said that applying water to the edible portion of a crop compared to the root zone can influence the food safety risk significantly. The same can be said of varying practices regarding soil amendments, he said.
“It is our intent to apply higher regulatory burdens on higher risk practices,” he said. The FDA knows that various agronomic practices vary by region and vary over time.
“If an agronomic practices is determined a risk, then the rule that ties controls that are in place strictly to a commodity will not take into the account that risk will vary from region to region and may vary as the industry moves to different practices,” he said.
Putting a higher regulatory burden on riskier practices should drive the industry towards alternative practices that are not as risky, he said.
Kraemer also said that concerns have been raised commodity-specific standards in multiple row crop operations. “If you define risk solely on the commodity itself you may end up with a high risk crop growing right next to a low risk crop next to a high risk crop,” he said. “If the idea was to apply different controls to different crops, you would end up with a fairly unmanageable situation in a small multi-row crop setting.”
What’s more, he said FDA has devoted considerable time evaluating what are considered “high risk” crops based on epidemiological data, but that process turned out to be difficult, Kraemer said. For one thing, he said the risk of any crop has as much to do with how much of that crop is consumed as it is by the risk of any particular commodity.
In addition, using contamination data by testing particular commodities is problematic. For one thing, the FDA doesn’t have a lot of contamination data. The other reason is that testing can be a self-fulfilling problem. “If you think you have a problem with cucumbers and you start testing cucumbers, you will probably find problems with cucumbers but if you haven’t chosen cucumbers you probably never find a problem with cucumbers,” he said.
Two significant challenges are apparent to evaluating risk based on agronomic practices, he said. One of those issues is the application of raw manure, and the time needed between application and harvest. The other is water directed to the edible portion of the crop and how that correlates safe harvest practices.
So the FDA has no easy task. In particular, I wonder how the FDA will devise a regulatory framework that is meaningful to grower operations of varying size throughout the country.
We shouldn't be surprised, I supposed, that the FDA wants to avoid targeting of particular commodities as "high risk." That would be a millstone for growers and invite litigation.
The industry will have opportunity to see more of the FDA's thinking when they publish the proposed produce safety rule. How soon that will be a is a question, however; Kraemer said the FDA's work on the produce safety rule is running later than the Congressional mandate of early 2012.