Risk assessments are often used by the federal government to estimate the risk the public may face from such things as exposure to a chemical or the potential failure of an engineered structure, and they underlie many regulatory decisions. Last January, the White House Office of Management and Budget (OMB) issued a draft bulletin for all federal agencies, which included a new definition of risk assessment and proposed standards aimed at improving federal risk assessments. This National Research Council report, written at the request of OMB, evaluates the draft bulletin and supports its overall goals of improving the quality of risk assessments. However, the report concludes that the draft bulletin is "fundamentally flawed" from a scientific and technical standpoint and should be withdrawn. Problems include an overly broad definition of risk assessment in conflict with long-established concepts and practices, and an overly narrow definition of adverse health effects-one that considers only clinically apparent effects to be adverse, ignoring other biological changes that could lead to health effects. The report also criticizes the draft bulletin for focusing mainly on human health risk assessments while neglecting assessments of technology and engineered structures.

Risk assessments are often used by the federal government to estimate the risk the public may face from such things as exposure to a chemical or the potential failure of an engineered structure, and they underlie many regulatory decisions. Last January, the White House Office of Management and Budget (OMB) issued a draft bulletin for all federal agencies, which included a new definition of risk assessment and proposed standards aimed at improving federal risk assessments. This National Research Council report, written at the request of OMB, evaluates the draft bulletin and supports its overall goals of improving the quality of risk assessments. However, the report concludes that the draft bulletin is "fundamentally flawed" from a scientific and technical standpoint and should be withdrawn. Problems include an overly broad definition of risk assessment in conflict with long-established concepts and practices, and an overly narrow definition of adverse health effects-one that considers only clinically apparent effects to be adverse, ignoring other biological changes that could lead to health effects. The report also criticizes the draft bulletin for focusing mainly on human health risk assessments while neglecting assessments of technology and engineered structures.

Distinguished by a practical focus on how federal administrative agencies make decisions and how political institutions influence and courts review those decisions, with coverage tailored to 1L or upper-level courses on the regulatory state or legislation and regulation. Uses primary source materials drawn from agency rules, adjudicatory orders, and guidance documents to show how lawyers engage agencies. Uses an accessible central example (auto safety) throughout to make the materials cohesive and accessible. Presents legislation with attention to modern developments in the legislative process. Presents statutory interpretation in useful terms, highlighting the “tools” that courts employ as well as the theories that judges and scholars have offered. New to the 4th Edition: Significant New Supreme Court decisions, with detailed Notes, on: textual statutory interpretation (Bostock v. Clayton County) the Major Questions Doctrine (West Virginia v. EPA) and the shifting Chevron framework arbitrary and capricious review (FCC v. Prometheus Radio Project) New Presidential and OIRA documents reshaping regulatory review, including: Executive Order on Modernizing Regulatory Review (Exec. Order 14094) Draft Revisions to Circular A-4 on Regulatory Analysis Updated coverage on scientific analysis in agency decision making New treatment of distributional analysis and consideration of equity in agency decision making Benefits for instructors and students: Tools-based approach that highlights the methods of analysis that agencies, courts, and lawyers utilize Use of an accessible central example as a familiar entry point into a complex legal area Primary source materials—agency documents, including notice-and-comment rules, adjudicatory orders, agency guidance, and more Empirical data, normative/theoretical questions, practical examples

Risk assessment has become a dominant public policy tool for making choices, based on limited resources, to protect public health and the environment. It has been instrumental to the mission of the U.S. Environmental Protection Agency (EPA) as well as other federal agencies in evaluating public health concerns, informing regulatory and technological decisions, prioritizing research needs and funding, and in developing approaches for cost-benefit analysis. However, risk assessment is at a crossroads. Despite advances in the field, risk assessment faces a number of significant challenges including lengthy delays in making complex decisions; lack of data leading to significant uncertainty in risk assessments; and many chemicals in the marketplace that have not been evaluated and emerging agents requiring assessment. Science and Decisions makes practical scientific and technical recommendations to address these challenges. This book is a complement to the widely used 1983 National Academies book, Risk Assessment in the Federal Government (also known as the Red Book). The earlier book established a framework for the concepts and conduct of risk assessment that has been adopted by numerous expert committees, regulatory agencies, and public health institutions. The new book embeds these concepts within a broader framework for risk-based decision-making. Together, these are essential references for those working in the regulatory and public health fields.

The EPA¿s Integrated Risk Info. System (IRIS) contains EPA¿s scientific position on the potential human health effects of exposure to more than 540 chemicals. Toxicity assessments in the IRIS database constitute the first two critical steps of the risk assessment process. Thus, IRIS is a critical component of EPA¿s capacity to support scientifically sound environmental decisions, policies, and regulations. This testimony discusses: (1) highlights of a report, ¿Chemical Assessments: Low Productivity and New Interagency Review Process Limit the Usefulness and Credibility of EPA¿s IRIS:¿; (2) key aspects of EPA¿s revised IRIS assessment process; and (3) progress EPA has made in completing assessments in FY 2008. Charts and tables.