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