The European Union’s health and food safety delegation in the United States is concerned that fees meant to fund a House Democratic proposal to beef up FDA’s inspection power will disproportionately hurt small manufacturers and importers. “What disturbs me the most is the fees do not progress based on the size of the business,” said Wolf-Martin Maier, counselor of food safety, health and consumer affairs at the Delegation of the European Commission to the United States. Maier said he has not delved into the proposal fully, but the fees and a few other points cause concern at first glance. Energy and Commerce Chairman John Dingell, Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., and Health Subcommittee Chairman Frank Pallone, D-N.J., proposed a discussion draft last week of legislation meant to give FDA more resources and authority to inspect and track foreign and domestic food, drug, medical device and cosmetic manufacturers. The additional agency responsibilities would be funded by annual registration fees totaling $600 million for food facility inspections alone. FDA also would be permitted to levy a reinspection fee on food firms that violate safety standards as well as charge food companies a fee for issuing an export certificate. Importers of all FDA-regulated products would be expected to pay a fee. The delegation took issue with a related bill introduced in the summer by Dingell, Stupak, and Pallone because it contained user fees based the number of line items in a shipment that also did not consider size.
Maier takes issue with a provision in the proposal requiring FDA to accredit laboratories that would conduct testing and sampling of shipments bound for the United States. Those labs already meeting international standards set forth by the International Organization for Standardization should be exempt, he said. “That’s why we have these international standard-making bodies,” he said. Maier also is concerned that the draft’s strict requirement of inspections of food facilities every four years and drug and device manufacturers every two years will spread FDA too thin. Instead, he said, the chairmen should consider a risk-based approach used by the European Union. “You should have the flexibility to allocate your resources to the risk,” he said. Maier has attempted to set up a meeting between Dingell and the delegation’s ambassador, but, in the meantime, said he and his staff will continue to meet with aides and submit comments.
This article appears in the April 26, 2008 edition of National Journal Daily PM Update.