The buzz around FSMA the past few weeks has centered on the new rules. There is a push to understand what the rules mean and what impact they will ultimately have. Missing from this push is a desire to comment on the rules. This is despite the rules being filled with assumptions and specific requests for comments. An opinion out this week from the D.C. Circuit Court of Appeals may change the desire to comment into a pragmatic need to comment on the proposed rules.
The D.C. Circuit dismissed a California farmer’s challenge to USDA rules requiring pasteurization of almonds. The plaintiff, Nick Koretoff, began fighting USDA-mandated treatment of almonds in court in 2008, arguing that the agency exceeded its legal power by effectively prohibiting the sale of raw almonds. His suit argued the rule provides an unfair advantage to almond importers, who are allowed to sell the untreated nuts in the U.S.
The D.C. Circuit dismissed the case on procedural grounds. The Court held Koretoff’s failure to object to USDA authority when the agency proposed the rule and sought comment meant he waived his claim to later challenge the rule.
After reading the Produce Safety Rule and Preventative Controls Rule do you believe there are portions that exceed agency authority? Do you have questions or need clarifications about what exactly the FDA is proposing to do? If so, the D.C. Circuit case makes it clear – comment or you’ll lose your change to challenge the rules later.
Leave a comment