JUSTICE DEPT TO TRACK RESEARCHERS

Act Restricts Certain Researchers' Use of Select Biological Agents

The U.S. Department of Justice intends to conduct background checks on
all Stanford researchers with access to certain biological agents
classified as "non-exempt select agents" by the Center for Disease
Control.

According to Ellyn Segal, biosafety manager for Stanford's Department
of Environmental Health and Safety, there are fewer than 50 people in
a handful of labs at Stanford who are currently using these agents.

So far, the CDC and the United States Department of Agriculture have
only required research institutions, including Stanford, to register
their select agents to each agency and have not yet requested names.

"Currently the federal government has not set up the mechanism to do
the checks," Segal said. "They state that they are 'in the process of
setting it up.' "

The Department of Justice checks are mandated by the Public Health
Safety and Bioterrorism Preparedness and Response Act of 2002. The act
was signed into law in June 2002 to establish measures by which to
enforce the USA Patriot Act of October 2001.

The Patriot Act designated groups of "restricted persons" who are no
longer allowed access to non-exempt select agents, a list which
includes the Ebola virus, the smallpox virus and the bacteria anthrax.

The background checks are intended to determine whether those with
access to non-exempt select agents fall into the category of
restricted persons and should therefore be denied access to them under
the Patriot Act.

Restricted persons may still work on versions of select agents which
have been exempted by the CDC, a list which includes certain vaccine
strains of viruses as well as toxin amounts less than 50 times the
standard lethal dose to a human.

Restricted persons include those who are on non-immigrant visas from
seven nations that the U.S. has deemed to be "state sponsors of
terrorism": Cuba, Iran, Iraq, Libya, North Korea, Sudan and Syria.

It also includes those who have been committed to a mental
institution, unlawful drug users, and those who have been discharged
from the armed services under dishonorable conditions.

"It's wrong to only focus on international students in this debate,"
said Ann Arvin, associate dean of research at Stanford. "The
restricted persons part includes people that had a dishonorable
discharge from the military, which might simply be because they're
gay. And what if you were busted in college for selling dope? These
are our restricted persons."

Steven Block, professor of biological sciences and applied physics,
questioned the ability of the Department of Justice to even check such
facts on international students.

"They didn't think it through completely for what happens if you're a
foreigner," Block said. "Our U.S. databases don't specify whether
Canadians have been in a mental institution, for example."

On Mar. 15, 2002, Charles Kruger, dean of research and graduate
policy, sent letters to over 1,100 Stanford researchers with access to
select agents, notifying them of the "restricted persons" section of
the Patriot Act and requesting them to self-report.

"The letter said that if you had a conflict [with the legislation],
the University would take all appropriate steps to get you on another
project," said Lauren Schoenthaler, an attorney in Stanford's Office
of the General Counsel.

But according to Segal, no one working on a non-exempt select agent at
Stanford has reported to Dean Kruger that he or she falls into the
category of "restricted persons."

One of Segal's main concerns is the fact that the CDC is making a
unilateral decision about the contents of the select agent list.

"They're not communicating," she said. "They're taking input, but
there's not a dialogue. In fact, Congress mandated that there be no
dialogue."

According to a CDC press release, the CDC is currently accepting
public comments on new, tighter restrictions on select agents that
were issued on Dec. 13, and those comments could result in regulatory
changes in the future.

Stanford previously submitted its input on Sept. 11, 2002, when Segal
and Assoc. Vice Provost Larry Gibbs sent a formal statement to the
CDC.

"We don't know whether they're going to pay attention to our comments
or not," Arvin said.

According to Schoenthaler, the Patriot and Bioterrorism Response Acts
designated two new major restrictions in addition to limiting access
to restricted persons.

First, the Patriot Act makes it illegal for anyone to possess a
biological agent or toxin that is not "reasonably justified," a
condition which includes "bona fide research."

Second, the Bioterrorism Response Act requires all research
institutions to register the possession of select agents as well as
the names of those who have access to them. Previous regulations only
required institutions to register the transfer of select agents.

The Patriot Act carries a fine and up to 10 years in jail while the
Bioterrorism Response Act carries a fine and up to five years in prison.

FBI has threatened a researcher with Patriot prosecution
already

This July, Tomas Foral, a graduate student at the University of
Connecticut, became the first person charged under the USA Patriot Act
for possession of a biological agent with no "reasonably justified"
purpose, the first major restriction identified by
Schoenthaler.

In October 2001, a freezer broke in Tomas Foral's lab, prompting him
and a fellow researcher to clean it out and transfer the vials inside
to a different freezer. The two reportedly found five to seven vials
containing frozen tissue samples from a cow that died of anthrax in
1968.

According to the university, Foral was told to destroy the samples.
However, he kept two vials in his own freezer, "thinking they may be
needed for future research."

In response to an anonymous tip by someone who saw the samples in
Foral's freezer space, the FBI entered the lab in full biohazard suits
on November 27, 2001 and confiscated the two tubes. The FBI
subsequently brought charges against Foral in July of this year.

Foral, who is a second lieutenant in the ROTC, chose a pretrial
diversion program to avoid prosecution. The program will involve two
years of community service.

"I have no choice," Foral said. "It would be very expensive to go to
trial. It would be unaffordable to me."

Under current law, it is legal for Foral to possess anthrax as long as
he is not a restricted person, and he is using it for "bona fide research."

Block said that this case exemplifies the problems with the acts'
wording.

"Is it sufficient just to possess a select agent in a strain
collection, or do I have to be conducting an experiment on it?" he
said. "Do I need to have a grant to work on it?

"They're going after someone who clearly doesn't fall under the
heading of bioterrorist."

Arvin has similar concerns about the effectiveness of the
acts.

"It's like checking the grandmas at the airport," she said.