Keep Food Legal Foundation submitted comments yesterday to the FDA on two supplemental rules the agency has proposed to implement as part of the Food Safety Modernization Act (FSMA).
"Our criticism of the proposed rules goes to the heart of the matter," says Keep Food Legal Foundation executive director Baylen Linnekin. "These rules would erect new costs and regulatory barriers without making food or consumers safer."
The basis of our criticism? The FDA's own data on the likely benefits provided under the rules--which the agency intends to be the centerpiece of its efforts to reduce the 48 million cases of foodborne illness in America each year--are slight at best, as our comments describe:
Even if all of the benefits possible under the supplemental rules proposed in Dockets No. FDA-2011-N-0920 and FDA-2011-N-0921 are realized, the maximum benefit of these FSMA rules would be a reduction of 5.3 percent of foodborne illnesses. Meanwhile, the agency also floats a break-even figure of reducing 228,000 cases of foodborne illness under the manufacturing rules. The benefits of such a reduction are incalculably small. And if that smaller figure were realized, then it would mean the two proposed supplemental rules, taken together, would reduce cases of foodborne illness by only up to 3.3 percent. Ergo, the new range for FSMA “success” is a paltry reduction in cases of foodborne illness of between 3.3 percent and 5.5 percent.
And that’s an optimistic view. The FDA offers no floor on its estimate that the revised produce rule will reduce up to 1.57 million cases of foodborne illness. If the revised produce rule prevents 1 million cases instead of 1.57 million, for example, then the lower end of the FDA’s predicted benefit falls to a 2.6 percent overall reduction. With this data in mind, it’s easy to see the disconnect between what Congress promised under FSMA and what the FDA rules are capable of delivering.
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In promoting FSMA, the FDA referred to foodborne illness as “a significant public health burden that is largely preventable.” Foodborne illness may be largely avoidable—through things like improved education and increased hand-washing. But the proposed supplemental rules contained in Dockets No. FDA-2011-N-0920 and FDA-2011-N-0921 demonstrate that FSMA has little to do with preventing foodborne illness, and much more to do simply with “modernizing” America’s food-safety regime. Taken together, the maximum benefits predicted by the FDA for the supplemental rules proposed in Dockets No. FDA-2011-N-0920 and FDA-2011-N-0921 are underwhelming. Their costs to producers, consumers, and taxpayers far outweigh their benefits.
Read our complete comments here. We also joined with other groups that support small farmers and ranchers by signing on to comments drafted by the Farm & Ranch Freedom Alliance. Read those comments here. And read more comments we've submitted on proposed food regulations impacting everything from food trucks to trans fats here.
