New Germ Labs Stir Debate Over Secrecy and Safety – Rocky Mountain Labs public comment period coming to a close

A flood of federal money has led to a building boom for high-security "hot labs," where the world’s deadliest germs and potential bioterrorist weapons can be studied.

The laboratories would more than triple the space to develop vaccines and treatments for anthrax, plague, hemorrhagic fevers and other killer pathogens, officials estimate.

By JUDITH MILLER

Scientists, biodefense experts and officials say the shortage of Biosafety Level 3 and 4 labs, those that handle the most dangerous forms or the most lethal germs, has hindered research on vaccines and treatments for diseases they cause.

"We desperately need this new space," said Dr. James M. Hughes, director of the infectious disease center at the Centers for Disease Control and Prevention.

Some biodefense experts challenge the need for so many highest-containment labs. Those experts say that heightened security, along with other recent federal actions aimed at controlling exotic germs, is greatly increasing secrecy and threatening to reduce the scientific openness that nourishes good research. They said the elaborate rules might also discourage scientists from working in the field,

"Becoming an armed camp to prevent organisms from falling into the hands of malefactors is a self-defeating approach," said Dr. Stanley Falkow, a professor of microbiology and immunology at Stanford, who has criticized Washington’s approach to biodefense.

Dr. Falkow decided last year to destroy his own plague cultures rather than abide by proposed regulations on germs that can be used as weapons. Even after the rules were loosened in response to complaints, he declined to work on such agents.

"These rules affect not just the scientists who work with me," he said, "but those who clean labs and all who have access to them. It’s just not worth it."

The projects are unsettling local residents and researchers, too, particularly near a proposed Level 4 lab at the Boston University Medical Center, near Roxbury.

"The issue is one of trust," said Dr. David M. Ozonoff, an epidemiologist at the Boston University School of Public Health. "Though I still support such a lab in principle for public health reasons, there aren’t sufficient safeguards to prevent work that violates the ethical standards of the scientific community. Nor can safety through civilian authority be assured."

The expansion is fueled by the National Institutes of Health, which has poured more than $1.7 billion a year into biodefense since the attacks of Sept. 11, 2001, and the lethal anthrax mailings a month later.

Last September, Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, announced that the institutes would grant $240 million to build two Level 4 National Biocontainment Laboratories, at the University of Texas Medical Branch at Galveston and Boston University. Weeks later, the infectious diseases agency issued an additional $120 million in grants ranging from $7 million to $21 million to nine institutions to build Level 3 space at the Regional Biocontainment Laboratories.

The institutes are also overseeing the construction of Level 3 and 4 centers a $66.5 million building at its Rocky Mountain Laboratories in Hamilton, Mont., and a 100,000-square-foot $105 million Integrated Research Facility with Level 3 and 4 laboratories near the Army research installation at Fort Detrick, Md.

Although the research budget of the acclaimed biodefense lab at Fort Detrick is supposed to be cut, the health institutes are more than doubling the Level 3 and 4 space at its Centers for Disease Control and Prevention, a spokesman for the centers said.

Moreover, an official of the health institutes said, so many universities and companies had built laboratories or were expanding them for Level 3 research that it was hard to determine how much Level 3 space existed.

"We’re considering conducting an inventory," said Rona Hirschberg, an administrator at the infectious diseases agency.

Dr. Richard H. Ebright, a professor of chemistry at Rutgers, who is a lab director at its Waksman Institute of Microbiology in Piscataway, N.J., called much of the Level 4 construction overkill, as well as a misdirection of scarce resources.

The needs, he added, "can be met entirely by the construction of a single large facility in a secure environment."

In interviews, Dr. Fauci and other senior American scientists and experts said more space was greatly needed, and they dismissed safety concerns. They said there had never been a documented case of illness in a community caused by an escaped pathogen from a high-security laboratory.

But many experts agree that such laboratories radically change scientists’ working conditions. Tighter security is evident, and not just at the Centers for Disease Control, which have armed the guards there, installed permanent perimeter fencing and taken other steps to ensure safety.

The University of Texas Medical Branch at Galveston, which won the grant to build the 13,000-square-foot Level 4 laboratory, has installed elaborate security at its new 2,000-square-foot "baby" hot lab, where about 12 researchers will soon start to work on viruses that cause diseases like Lassa and Crimean Congo hemorrhagic fevers.

Entry to the $15.5 million center, once open to most on campus, is now restricted to people with coded identity cards who pass through two checkpoints. Background checks on researchers are routine, and access to the Level 4 lab requires electronic fingerprints. The university is also installing special doors and posting armed guards.

On a tour, administrators called the lab a veritable "safe within a safe," separated on its own floor from the rest of the complex by pressurized air seals and welded scrubbed air ducts that filter air to and from the lab. In case of a loss of power loss, bioseals are to close off the lab automatically.

The lab is kept at a lower pressure than the atmosphere, so that a leak lets air in, not out. Scientists and technicians take chemical showers before and after work, which is carried out in pressurized suits and is monitored by security cameras.

Planning for the Level 4 complex, which will cost $750,000 a year to operate, began in 1997. Dr. David H. Walker, executive director of the Galveston branch’s center for biodefense and emerging infectious diseases, has slowly transformed a sleepy medical backwater into a top center to study naturally and unnaturally inspired disease. The center has recruited scientific superstars like Dr. C. J. Peters, its biodefense director who is widely known as the quirky hero who battled the Ebola outbreak in "The Hot Zone," the best-selling 1994 book by Richard Preston.

Since the attacks of Sept. 11, biodefense has become big business. Galveston received $3.7 million in federal grants in the 1996-1997 fiscal year. In fiscal 2003-2004, it won nearly $200 million.

Dr. Walker said some community groups were initially hostile to placing a hot lab in an area prone to devastating hurricanes. He and his staff, he said, met repeatedly with the community to explain safety measures.

Juan Pena, the president of the University Area Association and an employee of the institution, and Robert Mihovil, the program director of the group whose wife is a nurse at the campus, said the university had addressed their concerns.

"They really included us in the planning," Mr. Mihovil said.

Several community leaders said that was not the case in Boston, the other winner of the competition, where opposition to the hot laboratories has been building.

Although the University of Texas gave neighborhood groups an edited version of its grant application, Boston University did not do so for months. University representatives said the lab would not have classified work, but the application suggested that unidentified government subcontractors might work in the Level 3 and 4 areas, especially in the event of a bioterrorist strike or other national emergency.

The complex, near Roxbury, is in a poor and densely populated area.

"The university has been uncooperative, elitist and condescending," said Chuck Turner, the Boston City Council member who represents the area.

Mr. Turner, who has introduced a resolution in the council to keep Level 4 labs out of Boston, said he questioned using Federal Express and other such couriers to deliver dangerous materials to the lab.

Alternatives for Community and Environment, a neighborhood association, plans to sue Boston University and the Boston Redevelopment Authority to block the project for environmental reasons.

Dr. Sheldon Krimsky, a professor at Tufts, who is with the Council for Responsible Genetics, another opposition group, said he favored establishing a more active city biosafety committee similar to one formed in the mid-70’s in neighboring Cambridge to oversee research and to review building plans for safety.

In an interview, Dr. Mark S. Klempner, Boston University medical school’s associate provost for research, who is in charge of the project, said the laboratory would enhance the scientific and economic standing of the region and be a magnet for talent.

"That’s the biggest frustration," Dr. Klempner said. "A year after telling people all these things, we find ourselves in front of the same people who are not in favor of the project, who still supply no data supporting the threats they say exist, asking the same questions. There are groups out there that don’t really want a dialogue, which is what we want."

Public opposition helped thwart competitors for the federal labs. The University of California at Davis, 90 minutes northeast of Berkeley and highly regarded for its research on infectious disease, was not selected partly because of community opposition, critics and public health officials said.

Donald Mooney, a lawyer opposed to the lab, said his community group had sent more than 1,200 pages to the university and the N.I.H. documenting opposition.

"They would tell us which pathogens were on campus, but not their location or which researchers were working on them or the type of research that would be conducted," he said.

Maril Stratton, a spokeswoman at Davis, said the university had repeatedly reached out to newspapers, city officials and neighborhood groups to build support and had tried to be open and transparent in all its dealings.

"We made a most unusual effort to reach out," Ms. Stratton said. "But this is an activist community, and although the project was safe, it was a hard project. It sounded scary."

Concern that increased secrecy and security may harm science is increasing. Dr. Peters, head of the Galveston project, said he was worried that new restrictions might alienate researchers whom labs like his are trying to attract.

Dr. D. A. Henderson, who helped lead the campaign to eradicate smallpox and has been advising the federal health institutes for nearly two years, said the clash of cultures between scientific openness and tight security might not be resolvable.

"We’ve been well served by being pretty open," Dr. Henderson said. "And I worry about not sharing information that might advance the development of better antibiotics, more vaccines and drugs."

Dr. Hughes of the Centers for Disease Control said scientists would have to adjust to tighter security because of the growing threat of naturally occurring infectious diseases and bioterrorism.

"It took some of our people time to adjust," he said. "But most scientists understand the threat and are excited to take advantage of the new research opportunities that were never before available."

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Rocky Mountain Labs public comment period coming to a close
By JENNY JOHNSON Staff Reporter

http://www.ravallinews.com/articles/2004/02/10/news/news02.txt

The time allotted to weigh in on the planned expansion at Rocky Mountain Laboratories ends Thursday.

That’s when the public comment period concludes before the National Institutes of Health decides on whether to construct an integrated research facility at the Hamilton campus that would include a high-containment laboratory capable of housing the most dangerous pathogens.

The agency has been collecting comments on a supplemental environmental impact statement since its release in December. It replaced a draft document that was released last May. A final comprehensive study will assess the social, biological, cultural and physical impacts of the proposed facility. The study will be issued later this year, officials said, and will be the record of decision for the project.

A special team of officials at the National Institute of Allergy and Infectious Diseases, an arm of the NIH that oversees RML, will compile the list of comments and develop the final document with Maxim Technologies of Missoula.

The environmental impact statement is part of the National Environmental Policy Act and has drawn hundreds of comments, according to Vallerie Nottingham, environmental protection specialist at NIH.

She said there are fewer comments on the supplemental document than on the draft document, but all comments will be included in the final document.

In what would be the largest federal project to hit the Bitterroot Valley in recent years, officials are proposing to build a $67 million facility on the 33-acre Hamilton campus.

Concern over the project followed the federal government’s announcement for a biosafety level 4 lab to be built at the Hamilton neighborhood campus. Designed to be the safest and most secure type of laboratory, the level 4 lab is capable of housing pathogens such as hemorraghic fevers like Ebola, which causes fatal internal bleeding.

Several community members raised concerns about the potential danger such a lab poses to the community and how the community could respond to such a threat. Citizens have also been critical of the environmental impact statement itself, saying it doesn’t address all of the community concerns.

Added to the document in December were a historical assessment and quantitative analysis of safety records for these types of facilities, of which there are four currently in the U.S. The 238-page document addresses 103 separate comments received last year on the initial draft. Its focus is primarily on safety, air quality, noise, visual impact, wildlife, water quality and supply and economic effects.

The expansion proposal followed a directive from President Bush to beef up the country’s research into agents that could be used in a bioterrorism attack. Spawned by the terrorist attacks of Sept. 11, 2001, and ensuing anthrax scares, funding for bioterrorism research doubled. NIH chose to expand research at its Hamilton campus because of the history and experience that has developed at the lab for the last 75 years, officials said. RML currently does biological research on many pathogens, including tuberculosis, AIDS and chronic wasting disease in biosafety level 2 and 3 labs.

Public comment on the supplemental environmental impact statement will be accepted through Thursday. The document is available on the Internet at http://www.niaid.nih.gov/biodefense/public/envimpactstate.htm and at public libraries in Hamilton, Stevensville and Missoula. Comments should be sent to Vallerie Nottingham by e-mail at [email protected] or at NIH, B13/2W64, 9000 Rockville Pike, Bethesda, Md., 20892.

Reporter Jenny Johnson can be reached at 363-3300 or