FDA regulation should be rooted in reality


The Food Safety Modernization Act of 2011 was a great idea, but how the Food and Drug Administration planned to apply it to some Oregon farmers was not so great.

The Centers for Disease Control and Prevention says that every year about 48 million Americans get sick, 128,000 are hospitalized and 3,000 die from food-borne illness. The food safety act was another step to try to drive those numbers down.

One part of the act’s implementation are new strict standards the FDA proposed for E. coli in irrigation water for bulb onions. If the farmers don’t treat the water or the tests didn’t clear up, the farmers would have to shut down. Eastern Oregon farmers were worried they would have to set up expensive treatments when nobody argues there has ever been an E. coli problem with bulb onions.

The farmers complained. Rep. Greg Walden, R-Hood River, listened. He and other members of Congress met with the FDA. FDA officials traveled to Oregon to listen to the farmers.

“Yes their crop may have a low overall risk of contamination, and we are committed to issuing only those standards that are necessary for public health protection,” Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine, wrote during the trip. “But at the same time, we need to prevent illnesses from happening.”

That has the virtue of being the right thing to say. Better still would be for the FDA to actually have some hard science to understand what is necessary for bulb onions. Is the curing process Eastern Oregon farmers use now to prevent contamination enough?

That’s what an Oregon State University professor just got a grant to study. The Oregonian reported that if the FDA gets the necessary evidence, the onion farmers could get a waiver from the FDA.

The FDA’s mission of safety and protecting Americans doesn’t mean that its every effort is sacred. Whatever science may be driving it to tighten the rules on bulb onions, reality hasn’t revealed a notable threat.