In January during his State of the Union speech before Congress, President Barack Obama alluded briefly to an "initiative that will give us the capacity to respond faster and more effectively to bioterrorism or an infectious disease-a plan that will counter threats at home and strengthen public health abroad."  Although details about that initiative are not yet available, the fiscal year 2011 budget request from the administration calls for investing $476 million in advanced research and development, $171 million more than the 2010 enacted level to "accelerate development of new medicines, vaccines, and diagnostics for biodefense" within the within the Department of Health and Human Services (HHS), going beyond research programs funded by the National Institutes of Health (NIH) in Bethesda, Md.

Just before that initiative was announced, the bipartisan Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism released a strongly worded report criticizing federal officials and Congress for "not taking the necessary steps to protect the country from the threats posed by weapons of mass destruction and terrorism." While it gave "failing grades" to federal efforts to develop a "rapid and effective response to bioterrorism," it praised a federal "review of domestic programs to secure dangerous pathogens" and also the development of an "Interagency Bioforensics Strategy."

Even as the Obama administration seeks to accelerate research in this area, however, it and the Congress also continue to seek safeguards and possible new restrictions that could hamper research on many types of microbial pathogens. Last year, for example, Senator Joseph Lieberman of Connecticut, who chairs the Senate Homeland Security and Governmental Affairs committee, proposed the Weapons of Mass Destruction Prevention and Preparedness Act. Among other things, it seeks to restructure the Select Agent Program by creating a tiered system to enhance security requirements for more dangerous pathogens and lessen controls on others. However, there seems little likelihood that this bill will move forward anytime soon. Meanwhile, the biennial review of those select agents that is under way appears unlikely to adopt the proposals for reclassifying those agents that are outlined in the Lieberman bill.

The initiative to which Obama alluded in January appears to arise in part from the "National Strategy for Countering Biological Threats," which the administration announced last December. Key elements of that strategy include promoting "global health security" and reinforcing "norms of safe and responsible conduct." That new "strategy" outlines solid principles, according to Gerald Epstein, director of the Center for Science, Technology and Security Policy (CSTSP) at the American Association for the Advancement of Science (AAAS) in Washington. Moreover, it could prove valuable "for mobilizing resources" because it goes beyond national safety issues arising from concerns about bioterrorism attacks to address "disease threats in the real world," he says.

In a separate but related development last November, HHS officials released a draft guidance document, "Screening Framework Guidance for Synthetic Double-Stranded DNA Providers." Aimed mainly at companies that synthesize genes in vitro, it recommends that orders of double-stranded DNA that are 200 base pairs or greater be subjected to screening for sequences that encode, for example, toxins or virulence factors, particularly from pathogens that are on the select agents list-that is, which are considered potential agents of bioterrorism. The HHS guidance also urges DNA synthesis companies to verify that their customers are who they claim to be and are not likely perpetrators of bioterrorism attacks.

In January, stakeholders from universities, companies that focus on gene synthesis, and others gathered at an AAAS-sponsored workshop to review the HHS guidance document. Although participants identified several specific concerns and offered HHS several ways to address them, in general members of this industry niche and their counterparts at universities support the HHS set of voluntary recommendations, according to Epstein of CSTSP, who helped to organize the workshop.

Jeffrey L. Fox
Jeffrey L. Fox is the Microbe Current Topics and Features Editor.