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Guidelines in Development for Meeting New U.S. Biosecurity Standards

The Obama administration is set to circulate recommendations to assist jurisdictional organizations in complying with recently unveiled risk mitigation protocols for federally funded biological research that could raise concerns about misuse, the Center for Infectious Disease Research and Policy quoted a senior federal health official as saying on Tuesday (see GSN, March 30).

The U.S. National Institutes of Health intends to solicit feedback in coming weeks on the advisory material, National Institute of Allergy and Infectious Diseases head Anthony Fauci said during a National Academies event.

"From the top down, it's difficult to tell" which elements of the plan would be difficult for jurisdictional entities to put into effect, Fauci said.

The new standards, developed by the NIH Biotechnology Activities Office, would demand systematic federal government scrutiny of U.S.-financed studies incorporating any of 15 "high consequence" biological agents, including avian influenza, Ebola and anthrax. Examples of such sensitive research include two studies that increased the transmissibility of the avian flu virus. A federal biodefense panel only recently reversed a 2011 call for two scientific journals to withhold details from the studies (see GSN, April 30).

Expert panels acting on behalf of academic and other entities engaged in scientific studies would face challenges in meeting the new U.S. standards, Stanford University research dean Ann Arvin said prior to Fauci's remarks on the forthcoming recommendations.

A considerable number of academic institutional biosafety committees are not likely to possess sufficient knowledge necessary for analyzing the types and range of studies covered by the protocols, though they have gradually bolstered their pools of specialists, Arvin said.

"We at Stanford will not have experts for every pathogen," she said, adding a high chance exists that specialists in addressed areas would also  be participants in studies under review (Center for Infectious Disease Research and Policy release, May 1).

NTI Analysis

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This article provides an overview of the United States’ historical and current policies relating to nuclear, chemical, biological and missile proliferation.

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