Links to Resources
The prospect of using agents like
deadly bacteria and viruses as weapons has been
an issue for many decades, but the threat of using
them for biological attacks has risen dramatically
since the 2001 anthrax scares. Coming in the wake
of 9/11, the appearance of anthrax-laden letters
that killed 5 people and infected 18 others has
made officials acutely aware of both the importance
and danger of bioweaponry research. At the same
time that officials want access to potentially
deadly agents like the bubonic plague bacteria
and anthrax severely restricted, stocks of such
deadly organisms can be used for the development
of treatments and vaccines in the event of a bioterrorist
Following the anthrax letter incidents, the US
government adopted the Public Health Security
and Bioterrorism Preparedness Act of 2002, which
created new measures to control agents with potential
uses as biological weapons. The CDC subsequently
compiled a comprehensive list of over 80 biological
agents most threatening to public health and safety
or animal and plant health. Now under the regulation
of the CDC's Select Agents Program, any facilities
or individuals with possession of these agents
must register them with either the CDC or the
Animal and Plant Health Inspection Service (APHIS).
These new hazardous agent rules have affected
many scientists working on bacteria or viruses
on the select agents list. Scientists working
with select agents must now undergo time-consuming
FBI clearances complete with fingerprinting, criminal
checks, and interviewing of relatives and friends
. Researchers at Stanford chose to stop research
on select agents, believing that the "administrative
and security burdens of the select agent rule
outweighed the scientific need to maintain stocks
on campus" . Additionally, the costs of
upgrading facilities to accommodate sensitive
research are large. Louisiana State University
at Baton Rouge reported spending approximately
$130,000 in security systems for its labs, and
the University of Louisville altered floor plans
in its new science buildings in order to have
offices and labs in separate places [3,4]. Universities
across the nation are feeling the economic strain
accompanying these laboratory upgrades, and there
are concerns that "smaller universities,
without substantial financial resources, will
be 'locked out' by regulations" .
In addition to the financial concerns, universities
wishing to build new biosecure labs are having
to win the approval of local residents. In Boston's
South End, where Boston University plans to build
its NIH -funded $178 million biosafety level-4
BioSquare Research Park, some community residents
are fearful of the potential for accidental releases
into their neighborhoods, and are opposed to the
facility's construction . For the University
of Texas at Galveston, where another NIH-funded
biosafety level-4 lab is being constructed, community
attitudes were a bit more receptive as the University
was forthcoming and responsive to citizens concerns
from the start .
As for the research conducted behind laboratory
doors, tight security is warranted. Researchers
have been able to synthesize a smallpox viral
protein with the ability to block critical aspects
of the human immune response as well as create
a polio virus from piecing together DNA, turning
it to RNA and adding it to live cells [8,9]. This
type of "from scratch" research is termed
"synthetic biology" because of its ability
to link singular inert DNA fragments together
to form actual infectious agents like the polio
virus. Such microbial research is helping scientists
understand how vaccines would be most effective
in combating potential infections, but if scientists
can synthesize polio, they can eventually create
other more deadly infectious agents.
Consequences for scientists and researchers who
do not follow the new select agent rules are very
serious. The case involving researcher Thomas
Butler working with plague bacteria at Texas Tech
University proved that not following regulations
meticulously can lead to serious legal consequences.
Although Butler was cleared in December 2003 of
the most serious charges against him which included
lying to the FBI about 30 missing plague vials
and of being unaware of the regulations in place
for shipping dangerous pathogens, he was found
guilty of 47 other charges, most of which involved
fraud . In May 2004, assistant art professor
Steven Kurtz from State University of New York
at Buffalo had his home searched by FBI hazardous
materials agents after police found a home laboratory
with suspicious bacteria samples. Although he
was not charged with any terrorist activity, a
NY federal grand jury indicted both Kurtz and
his collaborator, University of Pittsburgh geneticist
Robert Ferrell, for fraudulently obtaining bacteria
from the American Type Culture Collection .
Even though the bacterial samples in this case
were not on the CDC's select agents list, the
case illustrates the aggressive nature with which
the FBI is prepared to pursue suspicious cases
involving biological agents.
With such elevated concern about the potential
of threatening research, the Secretary of Health
and Human Services announced in March 2004 that
HHS will begin to focus more on improving the
security around what is termed "dual-use"
research: certain types of legitimate biological
research that could potentially be dangerous to
public health or national security . To monitor
the status of dual-use research and advise government
officials on such projects, HHS is creating the
National Science Advisory Board for Biosecurity
" advise on strategies for local and federal
biosecurity oversight for all federally funded
or supported life sciences research.
" advise on the development of guidelines
for biosecurity oversight of life sciences research
and provide ongoing evaluation and modification
of these guidelines as needed.
" advise on strategies to work with journal
editors and other stakeholders to ensure the development
of guidelines for the publication, public presentation,
and public communication of potentially sensitive
life sciences research.
" advise on the development of guidelines
for mandatory programs for education and training
in biosecurity issues for all life scientists
and laboratory workers at federally-funded institutions.
" provide guidance on the development of
a code of conduct for life scientists and laboratory
workers that can be adopted by federal agencies
as well as professional organizations and institutions
engaged in the performance of life sciences research
domestically and internationally .
The Board will consist of up to 25 voting members
representing at least 15 governmental agencies,
and is scheduled to convene its first meeting
in Fall 2004.
On July 21, 2004, President Bush signed the Project
BioShield (P.L. 108-276) Legislation which will
give $5.6 billion over the next 10 years to fund
research, development and purchasing of vaccines
and drugs to protect Americans against deadly
diseases that could result from a bioterrorist
attack . The majority of the money is intended
to fund the creation of drugs and vaccines by
private drug companies, but there is a provision
that will give more money to the government for
the purpose of renovating and constructing more
biocontainment facilities at universities and
nonprofit institutions . The National Institute
of Allergy and Infectious Disease plans to award
6-12 grants of up to $4 million each for the expansion
of Biosafety Level 2 and 3 labs in the 2005 fiscal
year and 5-8 grants for the construction of more
Level 2 and 3 labs .
. Wilkie, Dana. "Scientists Turn from
Bioterror Research." The San Diego Union-Tribune.
June 1, 2004. http://tinyurl.com/5yyqn
. Gaudioso, Jennifer and Reynolds M. Salerno.
"Biosecurity and Research: Minimizing Adverse
Impacts." Science. Vol. 304. 30 April 2004.
. Borrego, Anne Marie. "Regulatory Overkill?"
The Chronicle of Higher Education. January 31,
. Malakoff, David. "Tighter Security Reshapes
Research." Science. 2002 (297): 1630-1633.
. Borrego, Ibid.
. Field, Kelly. "Residents Fight Boston
U.'s 'Biosafety' Laboratory." The Chronicle
of Higher Education. June 25, 2004.
. Field, Ibid.
. Office of Transnational Issues, Central Intelligence
Agency. "The Darker Bioweapons Future."
Unclassified. November 3, 2003. URL: http://www.fas.org/irp/cia/product/bw1103.pdf.
. Orwant, Robin. "Scientists Build Polio
Virus from Scratch." NewScientist.com. July
11, 2002. URL: http://tinyurl.com/598ke
. Malakoff, David and Martin Enserink. "Scientist
on Trial." ScienceNow. December 1, 2003.
. Matthews, Al. "SUNY Buffalo Art: It's
not bio-terror, but is it illegal anyway?"
CNN Headline News. July 13, 2004. URL: http://www.cnn.com/2004/SHOWBIZ/07/12/buffalo.art/
. HHS press release. "HHS Will Lead Government-wide
effort to Enhance Biosecurity in "Dual Use"
Research." March 4, 2004. URL: http://www.nih.gov/news/pr/mar2004/hhs-04.htm.
. HHS press release, Ibid.
. Garamone, Jim. "Bush Signs $5.6 Billion
BioShield Legislation." United States Department
of Defense. July 21, 2004. URL: http://tinyurl.com/5pm7t
. Garmone, Ibid.
. Field, Kelly. "New Law Increases Federal
Money for Biodefense Labs---at Expense of Other
Research Facilities." The Chronicle of Higher
Education. July 23, 2004.