FDA Lambasted For Lax Inspections

A HOUSE SUBCOMMITTEE sharply criticized the Food & Drug Administration on July 17 for its plans to close seven of 13 laboratories that test imported and domestic food. FDA Commissioner Andrew C. von Eschenbach was on hand to defend the agency.

Rep. Bart Stupak (D-Mich.), chair of the Energy & Commerce Subcommittee on Oversight & Investigations, said a series of food safety incidents in the past year already called into question FDA's ability and authority to regulate food and drug imports. Products from China-including contaminated seafood, toothpaste with diethylene glycol, and melamine in wheat gluten added to domestically produced pet food-have raised concerns about the safety of imports, Stupak said. FDA inspects less than 1% of food imports and samples only a small fraction of that 1%. "Closing the seven labs would make the situation even worse," he said.

David Nelson, an investigator on the oversight subcommittee staff, testified that FDA allows importers to arrange for testing of questionable goods at private labs that are not audited or overseen by the agency. If one of these private labs finds no contamination on five consecutive tests of an importer's goods, products from that importer are given a clean bill of health and are not subject to detention in the future, he said. If FDA closes more than half of its food testing labs, Nelson said, it will be even more reliant on the work of private labs, whose work FDA officials describe as "shoddy" and "driven by financial rather than scientific concerns."

The Agriculture Department has the authority to visit meat and poultry processing plants abroad and limit imports to 10 U.S. ports, Nelson said. But FDA has no authority to visit foreign processing plants for fish and produce and allows imports at more than 300 U.S. ports, only 90 of which have inspectors. "The San Francisco office has only four personnel to inspect one entry every 30 seconds," he said, illustrating the inspection challenge. FDA labs operate at a few ports, and the lab at the San Francisco port is scheduled to be closed.

In response to the apparent irony, von Eschenbach said closing seven labs is part of FDA's plan to bring the agency into the 21st century and make it more efficient. "We want to consolidate science so labs have modern techniques," he explained. Under FDA's plan, the six remaining labs will be enhanced to "have sufficient space to accommodate all of our analysts and equipment," he said. Employees at the seven closed labs will be given the opportunity to transfer to the enhanced facilities, he added.

Directors and personnel from the labs slated to be closed, however, said much expertise will be lost if their facilities are shut down. B. Belinda Collins, director of FDA's Denver District, which has a lab now slated for closure, said the loss of the 50 or so employees at the Denver lab "will result in a significant shortage of expertise and skill."

Rep. John D. Dingell (D-Mich.), chair of the full Energy & Commerce Committee, promised to introduce legislation to provide "additional resources and authorities to FDA to ensure that it can effectively monitor and control food and drug imports entering the U.S."

One day after the hearing, President George W. Bush announced the formation of an interagency working group to be headed by Health & Human Services Secretary Michael Leavitt. The group will identify steps that can be taken to promote the safety of imported products.