Oversight of Labs Handling Dangerous Germs Called Lax

WASHINGTON — The number of laboratories being built for the study of dangerous microbes is growing so rapidly that no one knows how much Americans are at risk from diseases caused by laboratory accidents, congressional investigators warned Thursday.

Officials of the Government Accountability Office said federal oversight is fragmented, and the safety of many of the facilities relies on "self-policing."

The rapid expansion of laboratories capable of containing dangerous agents such as Ebola virus and anthrax was partly spurred by the 2001 anthrax attacks that killed five persons.

But GAO toxicologist Keith Rhodes told the House Energy and Commerce oversight subcommittee that the laboratories themselves are probably making Americans "less secure" than they were before 2001.

He said one solution to a largely voluntary system of safety regulations may be to give laboratory inspectors at the Centers for Disease Control and Prevention in Atlanta police powers that would allow them "compel testimony, kick down walls and dig up pipes" if that seemed necessary, Rhodes said.

CDC inspections of laboratories is based on its regulation of handling of dozens of microbes, including deadly germs such as Ebola and lassa virus and less dangerous microbes like brucella. Because of the danger they pose to human beings and livestock, the microbes appear on a list of "select agents" maintained by CDC and the U.S. Department of Agriculture.

But members of the subcommittee pointed out that some germs, such as viruses that cause severe acute respiratory syndrome (SARS), hantavirus and dengue fever, are not on the select agents list and can be handled in university or commercial labs without officials from CDC or any other federal agency even knowing about it.

Members also were critical of CDC's inspection procedures, which consist primarily of record audits that are conducted during pre-announced laboratory visits.

Rep. Bart Stupak, D-Mich., chairman of the subcommittee, said the discovery by the nonprofit Sunshine Project in Austin, Texas, of an accident at a laboratory at Texas A&M University "may indicate that the periodic lab inspections that CDC carries out may not be as thorough as one might hope."

GAO released a report showing the rapid expansion of the number of laboratories designed to contain the most dangerous germs, Biosafety Level 4 (or BSL-4) labs that work with microbes that can cause fatal disease if inhaled and for which there is no cure, and BSL-3 labs for the study of germs that can cause potentially fatal disease.

In 2000 there were only five BSL-4 labs in the country, including two in Atlanta: one at CDC and one at Georgia State University. The other three were operated at the National Institutes of Health at Bethesda, Md., the Army's Research Institute for Infectious Diseases in Fort Detrick, Md., and a private foundation in San Antonio.

But in the past five years, the government has built nine new BSL-4 labs, universities have built four, and one was opened by a state government. Another is planned, the GAO said.

BSL-3 labs have proliferated even more rapidly, and no one knows how many of them exist, but the number is over 1,300, the GAO report stated.

Rhodes was asked whether he thought the country was more secure from a catastrophic disease incident because of the new laboratories or less secure.

"Less secure," he replied.

"BSL-3 and BSL-4 laboratories do not need any kind of permit, except a building permit," said GAO official Sushil Sharma.

Stupak also said the government was funding construction of many of the labs without a careful evaluation of how many were needed.

He asked Richard E. Besser, director of the CDC Coordinating Office for Terrorism Preparedness and Emergency Response, how many labs were needed.

"Six years ago I spent two weeks in Boca Raton in a Winnebago, working with the FBI investigating the attack" involving anthrax in that Florida city, Besser started to say, "and we were pretty scared about our abilities to deliver countermeasures."

"But do we need more labs or do we just need more Winnebagos?" Stupak asked.

Besser said he believed "the limitation on our ability to develop countermeasures in 2001 was based on the number of labs."

Besser also testified that he thought the country is safer from either a deliberate or accidental disease outbreak now than it had been prior to 2001.

Speaking with reporters after he had testified, Besser said the number of reported accidents at laboratories inspected by the agency have increased in recent months, probably because of the Texas A&M incident, which led to suspension of the university's CDC permit to handle select agents.

The incident, in which a research scientist was infected by brucella bacteria, was discovered by the Sunshine Project after the BSL-3 lab where the scientist was working had been approved by CDC inspectors.

The records describing the incident and uncovered by the nonprofit open records group had been available to the CDC inspectors, said Texas A&M President Eddie J. Davis.

Edward Hammond, director of the Sunshine Project, said greater "transparency" was needed to cause laboratories to operate more carefully.

However, he accused CDC of resisting his efforts to find out about laboratory inspections.

"The level of transparency at CDC with respect to select agents is, well, nonexistent. There is none," he said. "It is the apparent policy of the CDC to not even attempt to locate records about select agents."