DoD is developing defensive capability against biological agents and toxins. This study addresses these themes: Are current and proposed policies in DoD biological safety, security and biological personnel reliability programs adequate to safeguard against accidental or intentional loss/misuse of Biological Select Agents and Toxins (BSAT)? Are current DoD assoc. labs. that use or store BSAT meeting stringent standards for safety, security and personnel reliability? How do DoD programs compare with other gov¿t. agency, academic, and industry programs? How can DoD usefully employ experience in other areas requiring the utmost safety and reliability when handling dangerous material for biosurety policy dev¿t. and implementation?

The objectives of this project were to: assess the uniform application of biosafety and biosecurity policy and directives, plans, orders, and guidance across DoD component laboratories that were conducting research using biological select agents and toxins and to evaluate DoD biological safety and security at laboratories. We found that DoD had not maintained biosafety and biosecurity program management, oversight, and inspections of its BSAT laboratories according to applicable Federal regulations. BSAT laboratories in Military Services were inspected according to different guidance, standards, and procedures, risking dangerous lapses in biosafety practices. Lack of coordinated oversight of DoD laboratories led to multiple, missing, and duplicative inspections, and, therefore, an excessive administrative burden that could interfere with scientific research performance.

The National Academies of Sciences, Engineering, and Medicine was asked to articulate a 5-year strategic vision for international health security programs and provide findings and recommendations on how to optimize the impact of the Department of Defense (DOD) Biological Threat Reduction Program (BTRP) in fulfilling its biosafety and biosecurity mission. Because BTRP is just one of several U.S. government programs conducting international health security engagement, both the strategic vision and the success of the program rely on coordinating actions with the U.S. government as a whole and with its international partners. This report provides several recommendations for optimizing BTRP success in its current mission and the wider-looking strategic vision it proposes.

Congress requested that the U.S. Department of Homeland Security (DHS) produce a site-specific biosafety and biosecurity risk assessment (SSRA) of the proposed National Bio- and Agro-Defense Facility (NBAF) in Manhattan, Kansas. The laboratory would study dangerous foreign animal diseases-including the highly contagious foot-and-mouth disease (FMD), which affects cattle, pigs, deer, and other cloven-hoofed animals-and diseases deadly to humans that can be transmitted between animals and people. Congress also asked the Research Council to review the validity and adequacy of the document. Until these studies are complete, Congress has withheld funds to build the NBAF. Upon review of the DHS assessment, the National Research Council found "several major shortcomings." Based on the DHS risk assessment, there is nearly a 70 percent chance over the 50-year lifetime of the facility that a release of FMD could result in an infection outside the laboratory, impacting the economy by estimates of $9 billion to $50 billion. The present Research Council report says the risks and costs of a pathogen being accidently released from the facility could be significantly higher. The committee found that the SSRA has many legitimate conclusions, but it was concerned that the assessment does not fully account for how a Biosafety-Level 3 Agriculture and Biosafety-Level 4 Pathogen facility would operate or how pathogens might be accidently released. In particular, the SSRA does not include important operation risks and mitigation issues, such as the risk associated with the daily cleaning of large animal rooms. It also fails to address risks that would likely increase the chances of an FMD leak or of the disease's spread after a leak, including the NBAF's close proximity to the Kansas State University College of Veterinary Medicine clinics and KSU football stadium or personnel moving among KSU facilities.

"In May 2015, DOD discovered that one of its laboratories (formerly called the Life Sciences Division) at Dugway Proving Ground, Utah, had inadvertently made 575 shipments of live Bacillus anthracis -- the bacterium that causes anthrax -- to 194 laboratories and contractors worldwide from 2004 through 2015. A December 2015 investigation by the Army determined that there was insufficient evidence to establish a single point of failure and made recommendations for improving safety and security at DOD laboratories that handle BSAT. The NDAA for Fiscal Year 2017 included a provision for GAO to review DOD's actions to address the Army's recommendations. GAO assessed the extent to which (1) DOD has implemented recommendations from the Army's 2015 investigation report, (2) the Army has implemented the BSAT Biosafety and Biosecurity Program and developed a strategy and implementation plan, (3) the Army's biological T&E mission is independent from its biological R&D mission, and (4) DOD has carried out a required study and evaluation. GAO reviewed DOD documents and key actions in response to the Army's recommendations and conducted site visits to DOD's BSAT laboratories" -- Preliminary page.

In recognition of the vital need to protect legitimate facilities from the theft and misuse of dangerous pathogens and toxins, the Laboratory Biosecurity Handbook serves as a guide to the implementation of pathogen protection programs. The first sections of the book offer an historical overview of biological weapons activity, key principles of biosecurity and its integration into existing frameworks, as well as a discussion of biosecurity risk. Later sections discuss biosecurity risk assessments, describe detailed components of a biosecurity program, and offer a graded approach to biosecurity through multiple risk levels. The work also covers risk prioritization of biological assets and biosecurity training.

Examines the biological safety, security, and personnel reliability programs of DoD's biological labs, and compares these labs with other similar operations in academia, industry, and the federal government. Offers recommendations for improvements in the DoD program based on this comparison.