Bioterrorism

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 attack.

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 [1]. 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" [2]. 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" [5].

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 [6]. 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 [7].

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 [10]. 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 [11]. 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 [12]. 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 (NSABB) to:

" 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 [13].

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 [14]. 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 [15]. 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 [16].

Allison Chamberlain
August 2004

Notes:
[1]. Wilkie, Dana. "Scientists Turn from Bioterror Research." The San Diego Union-Tribune. June 1, 2004. http://tinyurl.com/5yyqn
[2]. Gaudioso, Jennifer and Reynolds M. Salerno. "Biosecurity and Research: Minimizing Adverse Impacts." Science. Vol. 304. 30 April 2004.
[3]. Borrego, Anne Marie. "Regulatory Overkill?" The Chronicle of Higher Education. January 31, 2003.
[4]. Malakoff, David. "Tighter Security Reshapes Research." Science. 2002 (297): 1630-1633.
[5]. Borrego, Ibid.
[6]. Field, Kelly. "Residents Fight Boston U.'s 'Biosafety' Laboratory." The Chronicle of Higher Education. June 25, 2004.
[7]. Field, Ibid.
[8]. 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.
[9]. Orwant, Robin. "Scientists Build Polio Virus from Scratch." NewScientist.com. July 11, 2002. URL: http://tinyurl.com/598ke
[10]. Malakoff, David and Martin Enserink. "Scientist on Trial." ScienceNow. December 1, 2003. URL: http://tinyurl.com/6nm9s
[11]. 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/
[12]. 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.
[13]. HHS press release, Ibid.
[14]. Garamone, Jim. "Bush Signs $5.6 Billion BioShield Legislation." United States Department of Defense. July 21, 2004. URL: http://tinyurl.com/5pm7t
[15]. Garmone, Ibid.
[16]. Field, Kelly. "New Law Increases Federal Money for Biodefense Labs---at Expense of Other Research Facilities." The Chronicle of Higher Education. July 23, 2004.