- How about an interim final rule?
O’Brien said some people think it would be better for FDA to publish an interim final rule so changes could be made after implementation. However, the federal rulemaking process isn’t that simple.
“An interim final rule can be a red herring,” O’Brien said. “The concern is that the interim rule would just stay on the books because to change it you have to go through the entire proposal and comment period process again.” That process generally takes years to complete, he said.
- Isn’t FSMA just a reaction to unsafe food from foreign countries?
Whitaker said he has heard many coffee shop conversations that blame imports for imposing regulations on the U.S. growers and shippers.
There is a nugget of truth to that rumor, O’Brien said.
“That drove some of it, but U.S. outbreaks were also a factor,” O’Brien said. “International trade law requires you to have the same rules for yourself as you do for other countries.”
Gorny said many off-shore operations have stellar food safety records and programs that are second to none.
O’Brien and Whitaker agreed, but O’Brien recalled how discussions on Capitol Hill after the 2006 E. coli outbreak linked to fresh spinach showed broad concern about imports.
“In the Senate hearing on the spinach outbreak, we were only three questions into the discussion when it turned to imports,” O’Brien said, adding that no imports were involved in that outbreak.
- When are consumers going to take some responsibility and wash their fresh produce before they eat it?
Gorny, who has a doctorate in plant biology and a master’s degree in food safety, has worked extensively with researchers in the past 25 years. He said science repeatedly has proved that consumer washing of produce can somewhat reduce pathogen risk, but it does not kill everything.
“Also, consumers can’t control who retailers buy from or other factors in the supply chain, so they have very little control,” Gorny said.
- Isn’t it just a money grab, especially if import fees are imposed to pay for it?
Gorny said the FDA knows there will be issues at the border once FSMA goes into
“User fees are still on the table because FDA doesn’t have the resources it needs,” Gorny said.