A compilation of currently available electronic versions of NRC regulatory guides.

The mission of Department of Homeland Security Bioterrorism Risk Assessment: A Call for Change, the book published in December 2008, is to independently and scientifically review the methodology that led to the 2006 Department of Homeland Security report, Bioterrorism Risk Assessment (BTRA) and provide a foundation for future updates. This book identifies a number of fundamental concerns with the BTRA of 2006, ranging from mathematical and statistical mistakes that have corrupted results, to unnecessarily complicated probability models and models with fidelity far exceeding existing data, to more basic questions about how terrorist behavior should be modeled. Rather than merely criticizing what was done in the BTRA of 2006, this new NRC book consults outside experts and collects a number of proposed alternatives that could improve DHS's ability to assess potential terrorist behavior as a key element of risk-informed decision making, and it explains these alternatives in the specific context of the BTRA and the bioterrorism threat.

Genome editing is a powerful new tool for making precise alterations to an organism's genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve human health. The speed at which these technologies are being developed and applied has led many policymakers and stakeholders to express concern about whether appropriate systems are in place to govern these technologies and how and when the public should be engaged in these decisions. Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing.

Does radiation medicine need more regulation or simply better-coordinated regulation? This book addresses this and other questions of critical importance to public health and safety. The issues involved are high on the nation's agenda: the impact of radiation on public safety, the balance between federal and state authority, and the cost-benefit ratio of regulation. Although incidents of misadministration are rare, a case in Pennsylvania resulting in the death of a patient and the inadvertent exposure of others to a high dose of radiation drew attention to issues concerning the regulation of ionizing radiation in medicine and the need to examine current regulatory practices. Written at the request from the Nuclear Regulatory Commission (NRC), Radiation in Medicine reviews the regulation of ionizing radiation in medicine, focusing on the NRC's Medical Use Program, which governs the use of reactor-generated byproduct materials. The committee recommends immediate action on enforcement and provides longer term proposals for reform of the regulatory system. The volume covers: Sources of radiation and their use in medicine. Levels of risk to patients, workers, and the public. Current roles of the Nuclear Regulatory Commission, other federal agencies, and states. Criticisms from the regulated community. The committee explores alternative regulatory structures for radiation medicine and explains the rationale for the option it recommends in this volume. Based on extensive research, input from the regulated community, and the collaborative efforts of experts from a range of disciplines, Radiation in Medicine will be an important resource for federal and state policymakers and regulators, health professionals involved in radiation treatment, developers and producers of radiation equipment, insurance providers, and concerned laypersons.

Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals contains a detailed and comprehensive methodology for developing acute exposure guideline levels (AEGLs) for toxic substances from inhalation exposures. The book provides guidance on what documents and databases to use, toxicity endpoints that need to be evaluated, dosimetry corrections from animal to human exposures, selection of appropriate uncertainty factors to address the variability between animals and humans and within the human population, selection of modifying factors to address data deficiencies, time scaling, and quantitative cancer risk assessment. It also contains an example of a summary of a technical support document and an example of AEGL derivation. This book will be useful to persons in the derivation of levels from other exposure routesâ€"both oral and dermalâ€"as well as risk assessors in the government, academe, and private industry.