FSMA-mania and myths

10/25/2013 12:00:00 PM
Coral Beach

O’Brien said the FDA won’t be able to impose such fees without action from Congress, though, because the agency doesn’t have that authority on its own.

  • How can I tell if I’m in compliance already?

No one knows if they are in compliance with the proposed rule as it now stands because FDA has not yet written the compliance documents that supplement the rule, Gorny said.

“FDA couldn’t tell you today if you are in compliance,” Gorny said. “We’re at the 50,000-feet level now, and the compliance guide doesn’t come until we get to the boots-on-the-ground level.”

  • Why doesn’t the rule require a written food safety plan?

Gorny said FDA officials considered requiring produce businesses to have written food safety plans but rejected the idea.

“Pieces of paper on a shelf don’t protect people,” Gorny said of the rationale used by FDA officials.


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