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The Homeland Security Act

US Patriot Act laws are curbing disease research say scientists

(Miami Herald / February 23, 2003) New federal laws meant to control bioterrorism are making it considerably tougher for researchers to continue work with such agents as anthrax and the plague, just as the United States reaches the brink of war with the country that supposedly possesses the greatest bioterrorism threat in the world.

Starting to take effect this month, the rules require all researchers to register bioterrorism agents with the federal government -- and make sure they are in secure facilities, which are rare and expensive to build.

Many researchers are burning their work, either on their own or at the demand of their universities, rather than put up with the tough federal requirements.

''Many investigators are destroying their materials. They're eliminating valuable archival materials,'' said Emmett Barkley, the laboratory-safety specialist at the Howard Hughes Medical Institute in Maryland who has been spearheading efforts by research scientists to persuade the federal government to modify or delay implementing the new regulations.

For the scientists, the main concern is understanding better how bioterrorism agents function and what vaccinations and other protections can be found.

For the federal government, the primary motive is security. ''We have some serious agents out there, and we have to make sure they don't fall into the wrong hands,'' said Dave Daigle, spokesman for the federal Centers for Disease Control and Prevention, which is charged with preparing and enforcing the regulations.

Before Sept. 11, scientists had to inform the government only when they were transferring dangerous biological agents from one place to another. After anthrax-tainted letters surfaced, authorities tightened requirements under the USA Patriot Act and other legislation.

The idea is that a terrorist or madman shouldn't be able to simply walk into a university office and swipe samples of deadly toxins.

''I don't have any problem with the concept,'' said Alvin Fox, a bioterrorism researcher at the University of South Carolina, ``but it's the implementation.''

Fox was so upset at the possibility of seeing his research stopped that he fired off a letter to a congressman, saying the new regulations are ``going to disrupt biological defense research . . . We are facing the possibility of a war with Iraq and this is not the time to provide major help to a potential enemy.''

AWAITING GUIDELINES

Scientists are also concerned that the Department of Justice has issued no guidelines about the criteria it will use in granting security clearances for bioterrorism researchers.

''We're getting a lot of calls from concerned researchers,'' Daigle said. ``About 800 facilities will be impacted. Many will decide to leave the business.''

The original deadline, imposed by Congress last year, was for scientists to register dangerous agents and have a security plan in place by Feb. 7.

''That was a very, very short period of time,'' said Barkley, ``for a very complicated situation.''

In the rush, said Barkley, the CDC is imposing ''very restrictive regulations,'' such as including a herpes virus on the bioterrorism list that many scientists think doesn't belong there.

DEADLINE PASSES

The Feb. 7 deadline appears to unofficially have drifted by as the CDC continued to seek comments and suggestions from the scientific community.

''We're not in a panic, but we are concerned,'' said Ronald Atlas, president of the American Society for Microbiology.

Still, earlier this month Fox was worrying that he would have to destroy 14 strains of brucella, considered by the U.S. Army to be one of the four most dangerous agents in a bioterrorism war because of its ability to travel through the air.

On the deadline day, Fox found a researcher at another university who was already registered with the federal government and was willing to take the strains.

However, at Kansas State, administrators decided to destroy anthrax strains left behind by a retired professor, said Kansas State researcher George Stewart.

''Absolutely,'' said Stewart, ''scientists like to keep all the strains they can,'' because they never know which ones might be mutants revealing interesting properties, but the institution decided it was easier to burn the strains rather than transfer them.

A major part of that decision is that it's unclear where the anthrax material could have been transferred.

SECURITY LEVELS

Airborne agents, such as Fox's brucella, require a level three security laboratory, which means two sets of doors with a vestibule between, a containment system within the lab so the agents can be handled safely, and negative air pressure, so that if there is a leak, air would flow into the lab, not out.

Such labs are one step below the highest level, the so-called ebola labs where researchers usually work in space-style suits.

But very few high-level labs now exist. The University of Miami has a level three lab, and a few UM researchers are registering under the new regulations, said Charles Gottlieb, in charge of UM lab safety. For security reasons, he won't say what strains they're working on. There are a few kinks in the regulations that need to be worked out, Gottlieb added, but the university generally is complying without too much difficulty.

In Gainesville, spokesman Philip Collis said the University of Florida has had a level three facility ''for many, many years'' and its scientists have found it ''fairly easy to comply'' with the new regulations.

Meanwhile, federal money is becoming available to build secure labs, but construction can't take place overnight.

At Kansas State, for example, architects are preparing plans for a $45 million level three facility. Construction could start this summer, but it might be a year or two before the lab is functioning.

Barkley, the Howard Hughes safety specialist, said in the meantime institutions can create makeshift level-three facilities by modifying modern laboratories.

Fox said he looked into that possibility at South Carolina, but was told the modifications would run about $400 a square foot, or about $240,000 for his small lab, which has a total annual budget of $150,000. ``We just can't afford it.''

The CDC reportedly is creating a repository where scientists can store their dangerous agents. Barkley said he has heard that the location will be an army bioterrorism center, but he has yet to learn any details about it.

Barkley said he is also concerned about the researchers themselves, who must submit applications for security clearances to the Justice Department by April 12.

The law states that researchers from countries considered to be sponsors of terrorism -- such as Iraq -- will not be allowed to work in U.S. bioterrorism facilities, but it is possible that other foreign nationals will also be excluded.

The Massachusetts Institute of Technology has already rejected a $400,000 federal grant because the institution refused to go along with the federal demand that participation by foreign researchers be restricted.

''I'm not sure the government is aware of how many foreign nationals and particularly students make up our community,'' Barkley said.

''The Patriot Act gives the attorney general great leeway in the use of criminal and other databases'' for determining who should be allowed in the laboratories, he said. ``We don't know how this will be carried out or whether will there will be opportunities for appeals.''