04/16/2008 - 10:39

In pursuit of international biosecurity oversight

Laura H. Kahn

Laura H. Kahn

A general internist who began her career in health care as a registered nurse, Kahn works on the research staff of Princeton University's ...

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Without a doubt, the implementation of bioresearch oversight must be an international effort. The United States has tried to take the lead in this area by mandating its National Science Advisory Board for Biosecurity to foster international collaboration when reviewing dual-use bioresearch. But after the United States stalled efforts to strengthen international treaties such as the Biological Weapons Convention, Washington's ability to persuade other nations to accept U.S. policies has declined. Fortunately, there's an alternative. A respected, international organization that can provide a forum to work out agreements already exists: It's called the Organisation for Economic Cooperation and Development (OECD).

An overview of the OECD

In 1948, Congress approved Secretary of State George Marshall's proposal to send $13 billion in economic aid and technical assistance to Europe to help rebuild the continent after World War II. The Organisation for European Economic Cooperation was established to administer the funds, and in 1961, it expanded its scope beyond Europe to include 20 other countries, changing its name to OECD in the process. Currently, it possesses 30 member countries, with plans to expand. The OECD's mission is to help its members achieve sustainable economic growth and develop the world's economy.

A respected, international organization that can provide a forum to work out bioresearch oversight agreements already exists: It's called the Organisation for Economic Cooperation and Development."

Given its history, the OECD has legitimacy and a solid reputation. In addition, it has already worked on biosecurity issues. For example, its members developed guidelines for Biological Resource Centers (BRCs) such as the German Collection of Microorganisms and Cell Cultures, which supplies microorganisms to various laboratories. Many other BRCs are scattered throughout the world. The World Federation for Culture Collections (WFCC) has records of 522 culture collections in 66 countries. Culture collections serve an important function, but their microorganisms must not fall into the wrong hands.

For example, in 1995, Larry Wayne Harris, a microbiologist and lieutenant in the Aryan Nations white-supremacist group, ordered Yersinia pestis (the plague bacteria) from American Type Culture Collection (ATCC), a mail-order laboratory. ATCC sent him three vials. Ultimately, he was sentenced to 18 months probation for mail fraud because he used a government laboratory phone number for ordering the bacteria for his private use. (See "In a Mysterious Germ Case, 2 Worlds Collide.")

Establishing guidelines for BRCs

In 1999, the OECD Working Party on Biotechnology began to draft quality standards for the maintenance and supply of microorganisms in culture collections. Its goal was to improve access to reliable sources of high-quality, authenticated cultures. A Task Force on Biological Resource Centers was formed to study the issue.

After the 2001 anthrax attacks, OECD organized a workshop on responsible stewardship in the life sciences. This set the stage for science ministers from OECD member countries to use the task force to develop guidelines that would improve the security of biological materials without inhibiting bioresearch.

The first challenge was to identify the most dangerous biological materials, which require additional security measures. World Health Organization laboratory biosafety guidelines already constituted a well-established source for classifying agents according to the need for containment measures to prevent accidental exposure. But the OECD needed a different system of classifying agents since it focused on how to prevent loss or theft of materials that could be intentionally used as biological weapons. The document its members wrote possesses two key components--risk assessment and risk management.

Risk assessment and risk management

Although respected institutions such as the U.S. Centers for Disease Control and Prevention (CDC) uses Category A, B, and C lists to describe risks of microbes, the task force found this approach problematic because a list-based approach ran risks of being either over-inclusive or under-inclusive. (See "The Weapon Potential of a Microbe.") Therefore, it recommended that BRCs assess a microorganism's virulence and potential for malicious misuse based on several underlying factors--e.g., its pathogenicity and environmental viability.

Risk management addresses the physical security of culture materials within institutions and the security of personnel, trainees, and visitors. The task force guidelines recommend that BRCs develop material control and accountability systems and incident-response plans for possible security breaches.

Consensus

In 2001, the OECD issued a report on the BRC concept, and six years later, OECD's Committee on Scientific and Technological Policy endorsed it.

Implementation

Several multinational efforts such as the European Biological Resource Centre Network and the WFCC are taking the guidelines into account. In September 2006, the OECD held a workshop with Russia on how to improve biosecurity in entities handling dangerous microorganisms; Russia is being actively courted to consider using these guidelines for their culture collections. (See "Towards a Global Plan to Fight Against Bioterrorism in Synergy with Russian Federation.")

Belgium has begun a cost-benefit analysis of the risk-assessment approach for facilities housing Biosafety Level 3 microorganisms. Meanwhile, France is using the guidelines to prepare a standard authorization form for the use of microorganisms and toxins and to prepare best-practice regulations for authorized facilities that work with hazardous biological material. The European Commission is considering how to use the guidelines to inform its set of harmonized minimum biosecurity requirements--see p. 9 of the "Green Paper on Biopreparedness." In addition, Brazil, Italy, China, Germany, and Japan are in the process of implementing the guidelines at the national level.

Future opportunities

The BRC experience shows that OECD can initiate policy changes that improve biosecurity--both in publicly funded bodies and private entities. I believe this success should lead to the establishment of an OECD Biotechnology Agency. It would be analogous to the OECD's Nuclear Energy Agency (NEA), which works on nuclear safety, radiation protection and public health, and radioactive waste management. The Biotechnology Agency could similarly ensure the safe, peaceful, and economically sound use of biotechnology. It's important to note that the NEA works with the International Atomic Energy Agency (IAEA). But even without a biological equivalent of the IAEA within the United Nations, the OECD could still help forge international consensus on addressing potential biotechnology security threats. Already, it's better at enhancing biosecurity than any other governmental body.