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FDA plan to close field labs draws fire

WASHINGTON—A Food and Drug Administration plan to close seven of 13 field laboratories has angered some lawmakers, government workers and safety advocates, who fear the move will chase away skilled veteran employees and hurt the FDA's ability to respond to public health emergencies.

The FDA's field labs inspect and analyze food, drugs, animal medications and feeds, medical devices and other health products.

The labs check for compliance with federal guidelines, protect consumers from unsafe, ineffective and mislabeled products, and help investigate public health threats such as product tampering, bio-terrorism, food-borne illnesses and contaminated blood supplies.

Several of the facilities helped investigate the recent pet food scare and E. coli and salmonella outbreaks in spinach and peanut butter. On the heels of these crises, the proposed lab closings have been met with strong suspicion.

"In the middle of all these outbreaks and contamination issues, the timing of the proposal is extraordinarily bad," said Chris Waldrop, director of the Food Policy Institute at the Consumer Federation of America.

Over the next several years, the FDA wants to close labs in Philadelphia; Denver; Detroit; Alameda, Calif.; Lenexa, Kan.; San Juan, Puerto Rico; and Winchester, Mass. Those operations and an estimated 250 employees would then be moved to five multi-purpose "mega-labs" that could handle all types of FDA testing.

The multi-purpose labs are in Atlanta; Jamaica, N.Y.; Jefferson, Ark.; Irvine, Calif.; and Bothell, Wash. A forensic chemistry lab in Cincinnati wouldn't be affected.

Most of the buildings slated for closure are older facilities, needing major renovations or complete replacement, said Diana Kolaitis, director of field operations at the FDA's Office of Regulatory Affairs. Most have expiring leases and aren't suited for expansion. The current roster of FDA labs occupy 500,000 square feet, but only 300,000 are being used.

"So all the (staff at) the labs that have been recommended for closure could easily fit into the remaining laboratories," Kolaitis said. Downsizing also would make investment in new lab equipment easier.

But some fear that fewer labs would delay the testing of food, biological medical products or drugs in the event of a public health emergency.

Kolaitis said proximity to the labs isn't a concern because testing samples could be sent to any facility by overnight mail. She noted that a network of state laboratories also is ready to assist in any food-related emergency.

Colleen Kelley, president of the National Treasury Employees Union, which represents about 150,000 government workers in more than 30 agencies, said most FDA employees wouldn't be willing to relocate to new lab locations.

"They'll simply go out into industry and get jobs in locations where they are today, and their experience and skill will be lost to the FDA," Kelley said.

To accommodate those employees who don't want to move, Kolaitis said the FDA intends to re-assign them to other jobs in their current locations and possibly use them to train their replacements at the new locations.

Waldrop of the consumer federation was unconvinced.

"If they're keeping people on and re-assigning them, they're still paying that person's salary, plus the new person you have to put in the lab, so where does that money come from in an agency that's strapped for cash?"

The FDA plan has faced skepticism in part because it was being implemented without input from Congress. Kolaitis said she now expects congressional hearings on the matter after more than 50 members of Congress asked the agency to halt the plan until it could be reviewed.

The plan was first revealed in December by an agency employee who leaked an internal e-mail on the proposal to the Public Employees for Environmental Responsibility (PEER), a nonprofit advocacy and service organization.

Similar plans have been floated at the FDA since the mid-1980s, and the agency decided in 1994 to go from 18 labs to 13. But a report by the Government Accountability Office determined that while the 1994 downsizing "could yield efficiencies, we found that the documentation and estimates of the benefits resulting from consolidation are questionable."

Jeff Ruch, executive director of PEER, said the FDA has again failed to explain how the proposed lab closings would improve the agency.

"If they have a good programmatic reason for doing it that explains why they'll be better at the end of the day, why keep it a secret? Why not lead with it? If they do that, I don't think you'll hear a peep of protest."

The lack of transparency has made lawmakers bristle as well.

In a letter to FDA Commissioner Andrew von Eschenbach, Rep. John Dingell, D-Mich., chair of the House Energy and Commerce Committee, said the FDA apparently decided to mislead the committee in a Dec. 26 letter that claimed that the restructuring plan hadn't been finalized and that "therefore, there are no changes to (FDA's) current laboratory structure."

Dingell later learned the FDA had disclosed the plan in November to a union that represents affected workers. "The refusal of the FDA to provide Congress with accurate information in response to the request by a Committee Chairman is completely unacceptable," Dingell wrote.

He has asked the FDA to provide all records relating to the plan since January 2005.

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