A Biological Threat Prevention Strategy: Complicating Adversary Acquisition and Misuse of Biological Agents

The risk of a biological attack is ever present. The relevant knowledge and material are becoming more widely available because of the global dispersion and rapid advances of technology, combined with its inherent dual-use nature. While technical challenges remain to a successful large-scale, high-impact biological attack, such an attack could kill tens of thousands of innocent civilians.

Unfortunately, a contradiction sits at the core of U.S. biological threat prevention policy. The United States has constructed an extensive domestic structure of controls and guidance. However, despite the U.S. government (USG) accepting the scientific and industrial costs of a domestic biosecurity system, it has not committed the diplomatic and financial resources needed to successfully promote the global adoption of similar systems.

While the safety and security of biological pathogens within the United States are important national goals, their pursuit has the potential to impede another crucial goal: a robust research and commercial enterprise. By regulating access to particular materials and facilities and increasing compliance costs, prevention measures probably create at least some inefficiencies in U.S. scientific, pharmaceutical, and public/animal health research. Making prevention policies too onerous could complicate regulation of the life sciences, driving portions of these communities out of the field, overseas, or underground, where regulation is impossible. Some analysts argue that U.S. policies have reached this level.

To make matters worse, domestic policies are insufficient to fully protect U.S. citizens, since they provide limited protection from attacks launched with pathogens brought into the United States from abroad. Biosecurity has become a global problem. With the rapid spread of technology and know-how, attacks that originate from less-regulated locales outside the United States are becoming increasingly serious risks to U.S. national security. It would be possible for an individual to surreptitiously carry a dangerous pathogen into the United States and, subsequently, develop and maliciously disseminate it without detection.

The USG has allocated significant resources to international bio threat prevention. However, despite pursuing some whole-of-government initiatives, U.S. efforts to promote prevention abroad have proceeded primarily at a program-by-program level. These programs offer partner nations a variety of engagement options, including training, education, and other resources to consolidate pathogen collections and manage risks in public and animal health facilities. Unfortunately, this work is largely bilateral, leaving the majority of countries unengaged.

Although the 2009 National Strategy for Countering Biological Threats identifies the importance of transforming international dialogue on this issue, the global components of U.S. policy are less well-resourced compared to bilateral outreach. In brief, U.S. bio-engagement policy is global in both strategy and concept, but not in resources or execution.

Despite various international calls for countries to pass laws to prevent non-state actors from misusing biology for harm, relatively few countries have done so. In fact, we only have a patchwork of regulations internationally. A few countries have constructed domestic control systems similar to that in the United States. However, several countries with burgeoning bioscience sectors—such as Brazil, China, and India—have weak legal and regulatory systems that, in some cases, are plagued with local corruption.

This means that the United States is bearing the full costs of domestic bio threat prevention without attaining the benefits of a thorough global prevention system.

The USG must correct this imbalance by reevaluating its policies both at home and abroad. This reevaluation should take the form of three action steps.

First, the administration should direct that a high-level analysis or analyses be conducted—including life science researchers, public/animal health experts, nonproliferation experts, economists, and trade experts—to weigh the costs and benefits of current and potential alternative U.S. bio threat prevention policies. The study should make this calculation assuming different levels of global adoption and observance.

This is an extremely difficult task given the wide range of variables, the difficulty of quantifying the benefits of particular biosecurity efforts, and the wide array of potential bio threat prevention tools and enforcement nodes. Although advocates argue strenuously on both sides of the issue, no integrated, high-level assessment has been conducted that systematically weighs the trade-offs—or potential synergies—between biosafety and biosecurity on the one side and science, industry, and public/animal health on the other. Such an analysis could, for example, study the number of U.S. patents and publications, the amount and quality of research, and the incidence of accidents before and after the enactment of dual-use research guidance, Select Agent regulations, and other changes in bio threat prevention policy. It could determine the costs—both direct and indirect—of compliance for individual facilities. It also could evaluate the number of known criminals, terrorists, or other restricted persons that the new policy has denied access to high-risk pathogens, and coordinate with intelligence communities to assess the contributions of these restrictions to public safety and security. It could delve into the qualitative experiences of researchers in these areas to determine whether they have redirected their research to avoid being subject to these rules. It also could seek the views of trade and international economists to evaluate what, if any, have been the repercussions of these rules on U.S. industry.

Second, the National Security Council should direct the development of a paper for principals-level review, six months after completion of the cost-benefit assessment, outlining in light of the assessment’s findings (1) how the United States should alter its total set of bio-threat prevention measures (if at all) to better balance their costs and benefits; and (2) the content and specific enforcement plans (if any) for a global bio threat prevention initiative.

It seems clear that a traditional arms control approach cannot be the centerpiece of such an effort. Discussions at the Biological Weapons Convention (BWC), United Nations, and in forums such as the Australia Group (created to harmonize export controls) can stimulate interest and build expertise in biosecurity among foreign bureaucracies, but they are not a complete solution to the challenges posed by twenty-first century bio-threats.

The right answer may entail a suite of bio-threat prevention initiatives, each with different levels of enforcement. One example of such a solution could be a series of global standards, coordinated through an international standards organization. Each group of standards would target different components of the life sciences enterprise—for example, laboratory bio-risk management, professional competencies, and managing dual-use research. These standards gradually could become more widely and stringently enforced. For instance, the standards could initially be established as international best practices. Economic pressures may prompt the community to pursue the creation of accreditation or certification systems to validate that a particular facility meets a certain standard or element of a standard. Prestigious journals could decide to publish only research that complies with appropriate bio-threat prevention standards. Although an international verification regime seems unlikely, certain countries may independently decide to implement some standards as national regulations.

Third, the National Security Council should task the development of a paper, within two months of the policy review, which outlines a specific plan to commit high-level resources to pursue the review’s recommended initiatives. For example, the plan should identify governmental staff to dedicate to the initiative; scientific, public/animal health, and industry representatives to serve as advocates; like-minded or influential states to approach early on; and international forums to push the initiative.

If the USG decides to pursue the development of a global bio-threat prevention initiative, one tactical approach would be to identify industries and nations that would support such an effort. An international, public-private partnership, including representatives from the public/animal health community, the pharmaceutical and biotech industries, the security community, and other key stakeholders, could work together to develop a consensus on content and method of implementation. This partnership could convene representative technical experts from around the world, and specific technical committees could be tasked with developing standards in specific disciplines of relevance to biosecurity—including, for example, standards for laboratory bio-risk management, professional competencies, and managing dual-use research. This process would create groups of experts who, under the framework established by the convening organization, could update and refine the standards as the scientific and technical context rapidly progresses. Once the technical committees have agreed to a set of standards in their respective areas, the representatives involved in creating them, along with the foreign ministries involved in their development, could advocate for their global adoption.

The path forward is difficult and complex, but it is also worthy and important. Anyone who has closely studied the impact of an effective biological attack on a civilian population would vastly prefer to stop the attack before it was launched. The type of analyses and initiatives urged here may show the path to such a strategy and help generate the momentum to pursue it. If the United States fails to act now, it will risk enduring the worst of both worlds: a domestic research enterprise entangled in regulations and bureaucratic procedures, and an international counterpart unfettered and ever more widely distributed and capable.

Carol Kuntz is a former visiting fellow with the Defense and National Security Group at the Center for Strategic and International Studies (CSIS) in Washington, D.C. Ren Salerno is a senior manager with the Cooperative Threat Reduction program at Sandia National Laboratories in New Mexico. Eli Jacobs is a research assistant and program coordinator with the Defense and National Security Group at CSIS.

Commentary is produced by the Center for Strategic and International Studies (CSIS), a private, tax-exempt institution focusing on international public policy issues. Its research is nonpartisan and nonproprietary. CSIS does not take specific policy positions. Accordingly, all views, positions, and conclusions expressed in this publication should be understood to be solely those of the author(s).

© 2013 by the Center for Strategic and International Studies. All rights reserved.

Ren Salerno, Eli Jacobs