The House Commerce Committee has asked the Department of Health and Human Services to seek another location for exotic influenza research that has been conducted at a government laboratory in Montgomery County near the White Flint Mall.
Rep. Thomas J. Bliley Jr. (R-Va.), the committee chairman, and Rep. Fred Upton (R-Mich.), the oversight subcommittee chairman, said they were worried about research on avian flu at the Food and Drug Administration's labs in the Nicholson Lane Research Center.
In a letter sent last week to Health and Human Services Secretary Donna E. Shalala, who oversees the FDA, the legislators said the complex "is located essentially next to a shopping center and the White Flint Mall in Rockville. We are concerned about the wisdom of locating a . . . laboratory in such proximity to the general public."
The letter expressed concern in general about biosafety at department labs there and at the National Institutes of Health, in nearby Bethesda. But the committee was especially worried about the handling of so-called biosafety level 3 materials--on a rising danger scale of 1 to 4--that are permitted at the Nicholson Lane facility.
The congressmen asked the department to report by early next year on locations that might be "alternatives" for the research.
A spokesperson for HHS referred queries to the FDA.
The FDA said research on potential vaccines for the avian flu that killed several people and sickened others in China two years ago was conducted last year at the Nicholson Lane lab. More may be conducted on a new, less dangerous strain that appeared this year, the agency said. None is underway now. The FDA said that the labs are designed to be safe and secure and that the amounts of flu virus used are small and not in the aerosol form that might infect humans.
"You're dealing with an appropriate level of protection to prevent this agent from infecting humans," said Jesse Goodman, deputy director for medicine at the FDA's Center for Biologics Evaluation and Research, which is conducting the research.
"These standards of protection have been designed by experts in laboratory safety and environmental health and are felt to ensure against that danger," Goodman said.
Some other experts agreed. "I wouldn't be concerned having a biolevel 3 facility in my back yard," said Matt Jackson, associate professor of immunology and microbiology at the Wayne State Medical School in Detroit. "They're pretty safe and pretty contained. You'd have a greater risk of catching the flu from somebody that you ride home on the subway next to."
Scientists rate the danger of microorganisms in a laboratory on a scale of 1 through 4 and call for corresponding levels of safeguards when handling such materials.
Level 1 refers to substances that are not known to cause disease, and it requires procedures like those used in a high school lab, according to the federal Centers for Disease Control and Prevention.
Level 2 refers to infectious agents such as measles and may require modest protective clothing, handling procedures and equipment.
Level 3 involves agents that may cause serious or potentially lethal diseases such as tuberculosis or encephalitis and requires stringent procedures and special containment equipment.
Level 4 concerns deadly, exotic agents such as Ebola about which little is known and for which there is no treatment. This level requires extreme handling caution and state-of-the-art lab facilities.
Flu research is generally considered to be level 2, but the avian flu study was conducted in the level 3 Nicholson Lane facility "to err on the side of safety," the FDA's Goodman said.
The Commerce Committee, which performs FDA oversight for Congress, became concerned after learning about the Nicholson lab's flu work and about a water leak in an FDA level 3 lab on the grounds of the National Institutes of Health two years ago.
Steve Schmidt, the committee's communications director, said the Nicholson lab is safe for level 2 testing.
"The question is whether it's safe for level 3, when they're testing pathogens that can be spread airborne," he said. "This is not a lab. This is an office building that has been turned into a lab."
Last summer, the General Accounting Office, at the behest of the committee, reported that the FDA first leased the Nicholson Lane office space in 1989. The agency gutted the inside and turned it into a laboratory research facility, with a level 3 lab where research on the AIDS virus was done.
The GAO also reported that at a Food and Drug Administration lab at NIH in January 1997, water from a loosened hose seeped from the supposedly sealed lab through a faulty pipe gasket in the floor and into a lab below. No research was underway, and no incident report was ever filed, the GAO found.
"It is disturbing that their response to this is, 'No harm, no foul,' " Schmidt said. "We're very troubled by that."
Don Peterson, director of office management for the biologics center, acknowledged that the leak at NIH should not have occurred and said it was quickly fixed. He said no report was filed because no one appeared to have been exposed to any agents.
As for an alternate site to Nicholson Lane, he said: "We can look for another place. But the work that's been done in that lab has either met or exceeded all of the safety procedures for working with the agents that we have been working with."
CAPTION: Rep. Thomas J. Bliley Jr. (R-Va.), the House Commerce Committee chairman, is concerned about a "laboratory in such proximity to the general public."