The incredible promise of synthetic biology notwithstanding, the rapid pace with which the field is evolving and the diversity of its practitioners present some uncertainties and potential biosecurity risks. The Board recommends that synthetic biology research be subject to institutional review and oversight and notes that NSABB’s proposed oversight framework for dual use life sciences research, which focuses on local level oversight, should adequately address much of this type of research.
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- March 14, 2012
This document contains the recommendations of the NSABB regarding the use of synthetic genomics to synthesize select agent nucleotides.
- March 14, 2012
Adherence to and Compliance with Arms Control, Nonproliferation, and Disarmament Agreements and Commitments
“Pursuant to statute (22 U.S.C. 2593a), the U.S. Department of State’s Bureau of Verification, Compliance, and Implementation issued a report providing a detailed assessment of the adherence of the United States and other nations to obligations undertaken in all arms control, nonproliferation, and disarmament agreements or commitments to which the United States is a participating state…”
- July 29, 2010
Whether or not the United States has safe and effective medical countermeasures—such as vaccines, drugs, and diagnostic tools—available for use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) plays a crucial role in the United States’ preparedness for public health emergencies through its regulation and approval of these medical countermeasures. However, FDA faces unique challenges in evaluating medical countermeasures. For example, conducting standard medical trials may be impractical or unethical when the product being tested is for use in a disaster, and assessing a product’s benefit versus its risk can be complicated if the chance of a disaster is very unlikely but the consequences would be dire if it did occur. FDA and the scientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available.
Two IOM forums—the Forum on Drug Discovery, Development, and Translation and the Forum on Medical and Public Health Preparedness for Catastrophic Events—held a workshop March 29-30, 2011, at the request of FDA, to examine methods to improve how medical countermeasures are developed, tested, and approved. Experts from federal government agencies, the private sector, and academia discussed opportunities to apply cutting-edge science to the product review process. This document summarizes the workshop.
- June 20, 2011
Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins
” An interim rule that established regulations governing the possession, use, and transfer of biological agents and toxins that have been determined to have the potential to pose a severe threat to public health and safety, to animal health, to plant health, or to animal or plant products. This action is necessary to protect animal and plant health, and animal and plant products.”
- March 10, 2010