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"With the passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 22, 2016, the main body of chemical management law in the United States changed dramatically. This guide summarizes the new law, highlights the changes that will have the greatest impact, and offers pertinent analysis on the implementation of the new law."--
The first and only guidance document to help applicants from chemical manufacturers obtain approval to synthesize and manufacture a chemical compound. Written by two EPA scientists, it provides coverage of chemical information needed for risk assessment to satisfy the requirements of the PMN review process and comply with the Toxic Substance Control Act.
The Department of Toxic Substances Control (DTSC) of the State of California Environmental Protection Agency is in the process of complying with the Regulatory Structure Update. The Regulatory Structure Update is a comprehensive review and refocusing of California's system for identifying and regulating management of hazardous wastes. As part of this effort, the DTSC proposes to change its current waste classification system that categorizes wastes as hazardous or nonhazardous based on their toxicity. Under the proposed system there would be two risk-based thresholds rather than the single toxicity threshold currently used to distinguish between the wastes. Wastes that contain specific chemicals at concentrations that exceed the upper threshold will be designated as hazardous; those below the lower threshold will be nonhazardous; and those with chemical concentrations between the two thresholds will be "special" wastes and subject to variances for management and disposal. The proposed DTSC system combines toxicity information with short or long-term exposure information to determine the risks associated with the chemicals. Under section 57004 of the California Health and Safety Code, the scientific basis of the proposed waste classification system is subject to external scientific peer review by the National Academy of Sciences, the University of California, or other similar institution of higher learning or group of scientists. This report addresses that regulatory requirement.
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.