The United States Environmental Protection Agency (US EPA) has formally released “problem formulation” documents for the risk evaluations it is conducting on the “first ten” chemical substances under the amended Toxic Substances Control Act (TSCA). Formal notice of the problem formulation documents was published in the Federal Register on June 11, 2018. Comments on the problem formulations must be submitted to US EPA on by July 26, 2018.
US EPA has stated that goal of the problem formulation effort is to produce a “conceptual model and an analysis plan” for each risk evaluation. The conceptual model “describes the linkages between stressors and adverse human health effects, including the stressor(s), exposure pathway(s), exposed life stage(s) and population(s), and endpoint(s) that will be addressed in the risk evaluation.” The analysis plan “is intended to describe the approach for conducting the risk evaluation, including its design, methods and key inputs and intended outputs.” Continue Reading