Evaluation Of The Updated Site Specific Risk Assessment For The National Bio And Agro Defense Facility In Manhattan Kansas

Safeguarding U.S. agriculture from foreign animal diseases and protecting our food system require cutting-edge research and diagnostic capabilities. The Department of Homeland Security (DHS) and the U.S. Department of Agriculture (USDA) have embarked on an important mission to replace the aging Plum Island Animal Disease Center (PIADC) with a new facility, the National Bio- and Agro-Defense Facility (NBAF). When operational, this new facility would be the world's fourth biosafety level-4 laboratory capable of large animal research. It would serve as a critical world reference laboratory for identifying emerging and unknown disease threats, and would thus be a critical asset in securing the future health, wealth, and security of the nation. DHS selected Manhattan, Kansas, as the site for the new NBAF after an extensive site-selection process that involved an environmental impact statement. The Government Accountability Office (GAO) raised concerns about DHS's analysis of the potential spread of foot-and-mouth disease virus (FMDv), one of the most serious foreign animal disease threats. Congress directed DHS to conduct a site-specific risk assessment (SSRA) for the NBAF, instructed the National Research Council (NRC) to independently evaluate the SSRA, and prohibited obligation of NBAF construction funds until the NRC review was complete. Congress mandated that DHS revise its SSRA to address shortcomings of the 2010 SSRA, directed the NRC to evaluate the updated SSRA (uSSRA), and again prohibited obligation of construction funds until the completion of the second review. The scope for both of these SSRA reports addressed accidental release of pathogens from the NBAF in Manhattan, Kansas and excluded terrorist acts and malicious threats from its risk assessments. Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas is the evaluation of the final uSSRA.

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.

Named to Kirkus Reviews’ Best Books of 2023 A ‘remarkable book.’ – The New York Times This fearless, deeply reported book about laboratory accidents asks the haunting question some elite scientists don’t want the public to entertain: Did the COVID-19 pandemic start with a lab leak in Wuhan, China? This is an obvious question. Yet there’s been an extraordinary effort by government officials in China, as well as leading scientific experts in the United States and around the world, to shut down any investigation or discussion of the lab leak theory. In private, however, some of the world’s elite scientists have seen a lab accident as a very real and horrifying possibility. They know what the public doesn’t. Lab accidents happen with shocking frequency. Even at the world’s best-run labs. That’s among the revelations from Alison Young, the award-winning investigative reporter who has spent nearly 15 years uncovering shocking safety breaches at prestigious U.S. laboratories for USA Today and other respected news outlets. In Pandora’s Gamble, Young goes deep into the troubling history -- and enormous risks -- of leaks and accidents at scientific labs. She takes readers on a riveting journey around the world to some of the worst lab mishaps in history, including the largely unknown stories of the lab workers at the U.S. Army’s Camp Detrick who suffered devastating infections at alarming rates during World War II. And her groundbreaking reporting exposes for the first time disturbing new details about recent accidents at prestigious laboratories – and the alarming gaps in government oversight that put all of us at risk. Sourced through meticulous reporting and exclusive interviews with key players including Dr. Anthony Fauci, former CDC Director Tom Frieden and others, Young’s examination reveals that the only thing rare about lab accidents is the public rarely finds out about them. Because when accidents happen, powerful people and institutions often work hard to keep the information secret.

This environmental impact statement presents an evaluation of the DHS proposal to site, construct and operate the NBAF. Operation of the NBAF as a biosafety level-3 (BSL-3) and BSL-4 research facility would allow basic and advanced research, diagnostic testing and validation, countermeasure development, and diagnostic training for addressing high-consequence livestock diseases to U.S. agriculture and public health. Six alternative NBAF sites are evaluated in the DEIS: Athens, Georgia; Manhattan, Kansas; Flora, Mississippi; Plum Island, New York; Butner, North Carolina; and, San Antonio, Texas. The No Action Alternative of not constructing and operating the NBAF is also analyzed.

Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

High-Containment Laboratories: National Strategy for Oversight Is Needed

Across the United States, thousands of hazardous waste sites are contaminated with chemicals that prevent the underlying groundwater from meeting drinking water standards. These include Superfund sites and other facilities that handle and dispose of hazardous waste, active and inactive dry cleaners, and leaking underground storage tanks; many are at federal facilities such as military installations. While many sites have been closed over the past 30 years through cleanup programs run by the U.S. Department of Defense, the U.S. EPA, and other state and federal agencies, the remaining caseload is much more difficult to address because the nature of the contamination and subsurface conditions make it difficult to achieve drinking water standards in the affected groundwater. Alternatives for Managing the Nation's Complex Contaminated Groundwater Sites estimates that at least 126,000 sites across the U.S. still have contaminated groundwater, and their closure is expected to cost at least $110 billion to $127 billion. About 10 percent of these sites are considered "complex," meaning restoration is unlikely to be achieved in the next 50 to 100 years due to technological limitations. At sites where contaminant concentrations have plateaued at levels above cleanup goals despite active efforts, the report recommends evaluating whether the sites should transition to long-term management, where risks would be monitored and harmful exposures prevented, but at reduced costs.