Under the administrative detention regulations as amended, an FDA officer or qualified employee will have authority to administratively detain food that the officer or qualified employee has “reason to believe” is adulterated or misbranded or is believed to have produced under unsanitary or unsafe conditions.
That standard, Merker said, is easier for the FDA to meet than the previous standard of “credible evidence or information indication that the article of food presents a threat of adverse serious healthy consequences or death to humans or animals.”
“Tell me which farm inspector or another qualified employee from FDA would inspect and could not find adulterated, misbranded food, or product made under unsanitary or unsafe conditions?” she said. “No case out there.”
So if the FDA puts more farms or facilities on administrative detention, she said they then could be set up to collect substantial fees when they return for a reinspection.
Likewise, while the regulation states that two examinations of a food must occur before the FDA can assess the new imported food fee, England said in the news release that the FDA has so broadly defined what constitutes the “first examination” that “virtually every imported food shipment on which FDA spends any resource will be subject to the re-examination fee.”
In the Federal Register notice, the FDA gave four examples when an importer can expect to pay a re-examination fee:
- When imported food is reconditioned or relabeled;
- When an importer is seeking release of an imported food under FDA detention;
- When an importer or foreign manufacturer petitions FDA requesting removal from FDA import alert; and
- When FDA supervises destruction of FDA refused food.
“These changes will dramatically increase the costs imposed on food importers and likewise, consumers,” England said in the release.
Merker said the best strategy to avoid paying reinspection user fees is to make sure food facilities are in compliance with U.S. laws and regulations and to maintain clear documentation of all corrective actions if there is a problem.