The rise of genetic engineering and recombinant DNA technologies have enabled scientists to develop new methods of therapy and healing for a variety of illnesses. These technologies allow researchers to manipulate the most basic elements of humans, animals, and disease-causing microbes alike. Although these innovations are generally intended for benevolent purposes, they have the potential to be misused to create virulent strains of bacteria and toxins for biological weapons.

In the past, the two main countries linked to biological weaponry research were the United States and Russia. In 1969, President Richard Nixon ended the United States' biological weapons program and "renounced unconditionally any future use of biological or toxic weapons."[1] Similarly, Russia renounced its program in April 1992 following orders by Russian President Boris Yeltsin. According to the U.S. government, North Korea, Iran, Syria, and Libya are points of concern for the government due to their suspected biological weapons programs and their potential to supply terrorist groups with such weapons. Currently, there are only two known instances of organized groups attempting to obtain and use biological weapons: the Rajneeshee group used salmonella in 1984 attacks in Oregon, and "the Japanese terrorist cult Aum Shinrikyo [which] tried…to develop and disseminate biological agents, including anthrax and botulinum toxin" in the early 1990s.[2]

In September and October 2001, letters laden with anthrax were mailed to Senators Tom Daschle and Patrick Leahy, as well as to several media outlets in New York and Florida. According to the Centers for Disease Control and Prevention (CDC), five people were killed and 18 others infected with anthrax after contact with these and other anthrax-contaminated letters.[3] In response to the anthrax incidents, the U.S. government adopted the Public Health Security and Bioterrorism Preparedness Act of 2002 (Public Law 107-188) in May 2002, which enacted new measures to control agents with potential uses as biological weapons.

In July 2002, as directed by P.L. 107-188, the CDC issued a "list of each biological agent and each toxin that has a potential to pose a severe threat to public health and safety."[4] Under these provisions, any facility or individual is required to register "the possession, use, and transfer of listed agents and toxins" with the CDC or the Animal and Plant Health Inspection Service (APHIS) and the CDC Select Agents program was established to monitor and regulate these select agents.[5] Additionally, only institutions or persons with "lawful purpose" are allowed to possess these agents, and certain individuals falling under eight categories issued by the Department of Justice are restricted from access to listed agents.[6] Facilities using these agents are also required to have secure facilities within which to experiment with these agents.

In July 2002, University of Connecticut student Tomas Foral was the first person to be charged under the new select agents rule when he was arrested and charged for possessing anthrax in a university freezer. He reportedly kept anthrax-infected animal tissues after being told to destroy the samples. In a similar incident, Thomas Butler, a researcher at Texas Tech University, was arrested in January 2003 for smuggling bacteria into the U.S. from Tanzania and lying to FBI agents about the disappearance of 30 vials of the CDC-listed bubonic plague bacteria. FBI agents accused Butler of lying about the vials because "he hadn't documented destroying them, as required by government rules."[7]

Among those affected by these new policies are universities, who now face new security provisions for research facilities that "carry requirements for implementation without necessarily providing resources to accomplish the governmental [security] mandates."[8] The cost of security upgrades is not small: Louisiana State University at Baton Rouge has reported spending approximately $130,000 to increase security at its laboratories.[9] At the University of Louisville in Kentucky, building planners altered floor plans for a new science building, putting office and labs in separate areas "so that students who might not have clearance to work in a lab could still meet with their professors."[10] Other universities have found that their laboratories "might have to be remodeled to meet security requirements."[11]

The costs of security enhancements, coupled with budget cuts, are leaving universities short of money and forcing universities to consider reallocating resources, possibly at the expense of other departments. Security upgrade costs have also triggered concerns that "smaller universities, without substantial financial resources, will be 'locked out' by regulations."[12] In attempts to resolve financial burdens, some universities have created new policies and adopted strategies seeking to refocus "attention and resources on existing areas of expertise that fit well with the funding priorities that have evolved since September 11."[13]

Along with upgrading facilities, university scientists are facing the increased paperwork to register select agents they possess with the CDC or APHIS. Numerous universities have chosen "to avoid greater paperwork by disposing of potentially problematic research materials."[14]

• Iowa State University at Ames discarded its "entire collection of anthrax specimens" after the Ames strain of anthrax was linked to the anthrax letters in October 2002.[15]
• At the University of Pennsylvania, researchers are disposing specimens "if they don't have a mission for the material."[16]
• Duke University officials are destroying select agents in "historical stocks" if there was no "current need" for the agents.[17]
• At Harvard University, biochemist R. John Collier destroyed his anthrax specimens "to avoid terrorists and more of the press than [he] wanted."[18]

Many of the specimens being discarded are key to understanding the workings of biological weapons and biodefense, so concerns about losing valuable research materials has led the White House to ask researchers "to reconsider their haste in doing away with specimens that could prove 'difficult or impossible to replace.'"[19] Specimen strains are essential to understanding the evolution of pathogens in nature, but researchers are discarding specimens because they "simply don't want to deal with the responsibility of housing deadly agents."[20] In an effort to prevent scientists from further discarding specimens that could prove important for future research, the federal government established a temporary repository in January to help preserve unwanted select agents.

Policies regulating biological agents and toxins aim to keep dangerous pathogens from possession by those aiming to weaponize them, but some scientists "doubt that controls could prevent the spread of dangerous knowledge or materials";[21] certain CDC-listed agents are readily accessible in areas experiencing outbreaks and equipment needed for weaponizing agents is "publicly available."[22]

Further complicating regulation of biological agents is the July 2002 publication of a synthetic poliovirus, showing that "infectious diseases can be built from off-the-shelf smidgens of DNA that are individually benign."[23] The ability to combine non-lethal bits of DNA into lethal viruses raised questions of regulating the "DNA synthesis industry" and creating tighter export controls on genetic material. Companies creating customer-specified DNA fragments use computer programs to compare requested fragments to known sequences, but company officials have voiced reluctance to "taking on the cost or legal responsibility of fingerprinting potential perpetrators."[24] Export controls on dual-use items such as genetic material already exist and are enforced by the Department of Commerce's Bureau of Industry and Security, but "only one microbiologist on staff…deal[s] with…biological export applications."[25]

Concerns about regulating select agents are heightened by the potential for overregulation of such specimens. Scientists caution against putting overly tight controls on these materials, possibly stunting the development of vaccines and cures for the listed agents as well as other infectious diseases.

Some scientists point to the 1975 Biological and Toxin Weapons Convention (BWC) as a possible means of regulating biological agents and experimentation. The BWC "does not prohibit research," but it prohibits "the development, production, or stockpiling of biological or toxic agents and of devices to deliver such agents."[26] However, the BWC does not have any enforcement mechanism to deter nations from developing biological weapons. In July 2001, the U.S. rejected an effort to fix this shortcoming because it would "not improve [the] ability to verify compliance...and will do little to deter those countries seeking to develop biological weapons." Additionally, government analysis saw the potential for this "draft Protocol [to] put national security and confidential business information at risk."[27]

In November 2001, after its rejection of the draft Protocol, the U.S. proposed new measures to strengthen the BWC including "national criminal legislation" against Convention violators, state provisions to secure pathogens, a mechanism for international investigation of suspected infringements of BWC restrictions, and increased cooperation with the World Health Organization.[28]

Joanne Chan
July 2, 2003

Notes

1 Harris, Elisa D. Testimony before the House International Relations Committee, Washington, D.C. 5 December 2001.

2 Ibid.

3 Council on Foreign Relations. "Terrorism: Questions & Answers- The Anthrax Letters." 4 June 2003.

4 PL 107-188. § 202(a)-Enhanced Control of Dangerous Biological Agents and Toxins. Public Health Security and Bioterrorism Preparedness Act of 2002.

5 Council on Foreign Relations. Ibid.

6 Council on Foreign Relations, Ibid.

7 Malakoff, David. "Plague of Lies Lands Texas Scientist in Jail." Science. 299(2003):489-490.

8 Bloedel, James R. "Impact of September 11 on Funding Priorities and Campus Programs." Science at a Time of National Security. Merrill Advanced Studies Center. June 2002 (106).

9 Borrego, Anne Marie. "Regulatory Overkill?" The Chronicle of Higher Education. 31 January 2003.

10 Malakoff, David. "Tighter Security Reshapes Research." Science. 2002(297): 1630-1633.

11 Ibid.

12 Borrego, Ibid.

13 Bloedel, Ibid.

14 Malakoff, Ibid.

15 Schemo, Diana Jean. "After 9/11, Universities are Destroying Biological Agents." The New York Times. 17 December 2002.

16 Ibid.

17 Ibid.

18 Ibid.

19 Ibid.

20 Borrego, Ibid.

21 Schemo, Diana Jean. "Sept. 11 Strikes at Lab Doors." The New York Times. 13 August 2002. 13 August 2002.

22 Harris, Ibid.

23 Weiss, Rick. "Mail-Order Molecules Brew a Terrorism Debate." The Washington Post. 17 July 2002: A1.

24 Harris, Ibid.

25 Harris, Ibid.

26 Wheelis, Mark. "Deterring Bioweapons Development." Science. 291(2001): 2089.

27 Mahley, Donald S. Statement to the Ad Hoc Group of the BWC States Parties, Geneva, Switzerland. 25 July 2001.

28 Bolton, John R. Statement to the Fifth BWC Review Conference, Geneva, Switzerland. 19 November 2001.