The Use of Systematic Review in Epa's Toxic Substances Control ACT Risk Evaluations


Book Description

Systematic review - a scientific investigation that focuses on a specific question and uses explicit, prespecified scientific methods to identify, select, assess, and summarize the findings of similar but separate studies - has become the foundation for assessing evidence to be used for decision making in a variety of health contexts, including health care and public health. At the request of the Environmental Protection Agency (EPA), this publication reviews EPA's 2018 guidance document Application of Systematic Review in TSCA (Toxic Substances and Control Act) Risk Evaluations and associated materials to determine whether the process is comprehensive, workable, objective, and transparent.




Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control ACT (Us Environmental Protection Agency Regulation) (Epa) (2018 Edition)


Book Description

Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (US Environmental Protection Agency Regulation) (EPA) (2018 Edition) The Law Library presents the complete text of the Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (US Environmental Protection Agency Regulation) (EPA) (2018 Edition). Updated as of May 29, 2018 As required under section 6(b)(4) of the Toxic Substances Control Act (TSCA), EPA is issuing a rule that establishes a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. This process incorporates the science requirements of the amended statute, including best available science and weight of the scientific evidence. Risk evaluation is the second step, after Prioritization, in a new process of existing chemical substance review and management established under recent amendments to TSCA. This rule identifies the steps of a risk evaluation process including: scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination. This process will be used for the first ten chemical substances undergoing evaluation from the 2014 update of the TSCA Work Plan for Chemical Assessments (to the maximum extent practicable). Chemical substances designated as High-Priority Substances during the prioritization process and those chemical substances for which EPA has initiated a risk evaluation in response to a manufacturer request, will always be subject to this process. The final rule also includes the required "form and criteria" applicable to such manufacturer requests. This book contains: - The complete text of the Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (US Environmental Protection Agency Regulation) (EPA) (2018 Edition) - A table of contents with the page number of each section




Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control ACT (Us Environmental Protection Agency Regulation) (Epa) (2018 Edition)


Book Description

Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (US Environmental Protection Agency Regulation) (EPA) (2018 Edition) The Law Library presents the complete text of the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (US Environmental Protection Agency Regulation) (EPA) (2018 Edition). Updated as of May 29, 2018 As required under section 6(b)(1) of the Toxic Substances Control Act (TSCA), EPA is issuing a final rule that establishes the process and criteria that EPA will use to identify chemical substances as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time. The final rule describes the processes for formally initiating the prioritization process on a selected candidate, providing opportunities for public comment, screening the candidate against certain criteria, and proposing and finalizing designations of priority. Prioritization is the initial step in a new process of existing chemical substance review and risk management activity established under TSCA. This book contains: - The complete text of the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (US Environmental Protection Agency Regulation) (EPA) (2018 Edition) - A table of contents with the page number of each section




Ecological Hazard Evaluation and Risk Assessment Under EPA's Toxic Substances Control Act (TSCA)


Book Description

Ecological hazard and risk assessment methods have been developed by the U.S. EPA to systematically evaluate new chemicals, existing chemicals, and genetically engineered microorganisms (OEMs) regulated by the Office of Toxic Substances (OTS) under the Toxic Substances Control Act (TSCA). About 70 000 existing chemicals are already on the TSCA Inventory, with thousands of new chemicals being assessed each year for their eventual manufacture and placement on this inventory. New chemicals have little or no ecological test data to evaluate. This lead to the development and regular use by OTS of Quantitative Structure Activity Relationships (QSARs) to evaluate the potential hazards of new chemicals to aquatic organisms. The estimates of hazard for existing chemicals and OEMs are mostly based upon test data supplied by industry. Over the last decade, OTS has identified several test endpoints of ecological concern, developed a scheme for the tier-testing of chemicals, provided guidelines on the methods for performing such tests, and evaluated and/or developed ecological data used in the assessment of thousands of chemicals. Estimates of aquatic and terrestrial hazards are compared with the concentrations of substances expected in the environment and an evaluation of the potential risk made. Ecological risk methods vary from the simple comparison of the potential hazards with the estimated exposure (that is, the quotient method) to simulation modeling.




Science and Decisions


Book Description

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.




EPA Toxic Substances Program


Book Description










Science and Judgment in Risk Assessment


Book Description

The public depends on competent risk assessment from the federal government and the scientific community to grapple with the threat of pollution. When risk reports turn out to be overblownâ€"or when risks are overlookedâ€"public skepticism abounds. This comprehensive and readable book explores how the U.S. Environmental Protection Agency (EPA) can improve its risk assessment practices, with a focus on implementation of the 1990 Clean Air Act Amendments. With a wealth of detailed information, pertinent examples, and revealing analysis, the volume explores the "default option" and other basic concepts. It offers two views of EPA operations: The first examines how EPA currently assesses exposure to hazardous air pollutants, evaluates the toxicity of a substance, and characterizes the risk to the public. The second, more holistic, view explores how EPA can improve in several critical areas of risk assessment by focusing on cross-cutting themes and incorporating more scientific judgment. This comprehensive volume will be important to the EPA and other agencies, risk managers, environmental advocates, scientists, faculty, students, and concerned individuals.