
Amidst Increased Scrutiny, FDA Wants to Shut Testing Labs
by Sam Kim, 7/24/2007
Amidst increased scrutiny by the public and Congress of the problems with food imports and instances of bacterial outbreaks in the domestic food supply, the U.S. Food and Drug Administration (FDA) plans to close 7 of 13 laboratories that test for food safety.
Testifying July 17 before the House Energy and Commerce Committee's subcommittee on Oversight and Investigations, FDA commissioner Andrew C. von Eschenbach said that the closings will enhance FDA's capabilities. "Consolidating our work into six laboratories whose capacity will meet and even exceed the capacity of FDA's 13 existing field laboratories will strengthen and increase ORA's [Office of Regulatory Affairs] analytical capabilities to meet the challenges of the 21st Century," he wrote in his formal testimony.
But an investigation by the subcommittee's staff this year and other witnesses appearing before the subcommittee brought that conclusion into question. According to findings presented to the subcommittee by David Nelson, the subcommittee staff's lead investigator, the restructuring proposal and food safety approaches have several flaws. His testimony countered von Eschenbach's statements about the strides FDA has made in food safety protections. Nelson found:
- that FDA lacks sufficient resources and authority to adequately protect food safety;
- that FDA's proposal to change the structure of the labs exacerbates the food safety problem; and
- that "FDA's current regulatory approach, that relies on voluntary guidelines for most domestic and imported foods, appears inadequate in responding to the changing food industry."
During the investigation, subcommittee staff visited ports of entry and FDA labs and interviewed field personnel involved in food safety inspections. According to these interviews, FDA allows private labs, over which it has no oversight authority, to do food safety testing of imports. FDA allows food suspected of being unsafe to be returned to importers, and the importers have the food tested by private labs.
One FDA deputy lab director described the work of the private labs as "spooky" and "scary." Another FDA official concurred with this conclusion saying the labs are not adequately performing because they are driven by financial considerations and not safety considerations.
According to Nelson's testimony, FDA has failed to provide any analysis justifying the "radical reorganization." Labs in Detroit, San Francisco, Denver, Kansas City, San Juan, Puerto Rico, Philadelphia and Winchester, MA are proposed for closing. At a time when food safety issues have created a public health "crisis," the rationale for the closings seems to rest on little other than expected retirements and vacancies.
House Energy and Commerce Committee chairman John Dingell (D-MI) has stopped the labs from closing pending a report from the Government Accountability Office (GAO) analyzing the agency's reorganizational plans, according to a New York Times article. Additionally, the Senate and House Appropriations Committees passed Agriculture spending bills July 19 that prohibit FDA from implementing its plans.
Additional witnesses testified before the subcommittee about other flaws in the food safety net. For example, Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, testified that FDA is poorly funded and jurisdiction over food safety is split primarily between FDA and the Department of Agriculture (USDA).
She also called for Congress to dramatically increase FDA's funding, update food safety laws which are over a century old, and create one food safety agency to overcome the jurisdictional splits among FDA, USDA and other agencies with some food safety responsibilities.
Also testifying was William K. Hubbard, former FDA associate commissioner who retired in 2005. He detailed the lack of funds and lost personnel the agency has experienced in recent years:
…the food program, in particular, has undergone steady budget cuts: the staff of FDA's headquarters food program has been reduced from almost a 1000 scientists to fewer than 800 in just five years; and FDA's field force, which includes its inspectors and import staff, has dropped during that period from over 4000 to about 3300 today. Of course, this is at a time in which the problems are growing and food imports are skyrocketing. The current budget request for Fiscal Year 2008 is a good example of the recent trends. Although the official budget request states that it includes an "additional" $10 million for food safety, the food program's inflation needs are not covered by the request, so the practical effect of that budget is a 3% (or $14 million) decrease (even with the $10 million "increase").
The subcommittee heard from nine witnesses in all, several of whom are or were FDA district officials. There are several legislative proposals pending in Congress to address the problems at FDA in light of the rapid increase in food imports and the fractured jurisdictional responsibilities among federal agencies.
