On June 22, 2017, the U.S. EPA issued a seminal guidance document related to the implementation of the LCSA – “Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations under the Toxic Substances Control Act”. The LCSA required the USEPA to develop this guidance to assist external parties in submitting draft risk evaluations for consideration by the USEPA. The guidance states that “EPA’s vision is to have a sustainable TSCA program that is meaningfully informed by high-quality risk evaluations conducted by external parties”. In addition to issuing this guidance, EPA may consider the development of a “voluntary consensus standard” for the conduct of risk evaluations.
Included in the document is guidance regarding scientific standards required for LCSA risk evaluations and how each element of the LCSA risk evaluation process should be developed. A stated goal is “to ensure that external parties have flexibility to use best available science by adapting and keeping current with changing science”. As such, the guidance is a framework and avoids being prescriptive about specific methodologies and approaches to be employed, and embraces concepts such as fit for purpose, weight of evidence, reasonableness, consensus, and best available science. The guidance also discusses, and encourages where appropriate, the use of alternative approaches to toxicology and dose-response relationships.
For more information about this seminal guidance, details about alternative approaches and methodologies that may be used, and assistance with developing draft risk evaluations, please contact ToxStrategies here. Additional information about our specific services related to implementation of LCSA can be found on our website here.