June 29, 2017
On June 22, 2017, EPA released the “Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations Under TSCA.”. The guidance is intended to help interested parties submit draft chemical risk evaluations that shall be considered by EPA as part of its risk evaluation for a particular chemical. EPA states that this guidance will be re-evaluated every five years and could be used as a means for providing additional transparency regarding the risk evaluation process. The guidelines are consistent with the steps outlined in the risk evaluation rule, including consideration of best available science, weight of evidence evaluations, systematic review and data quality considerations. The guidelines indicate that interested parties should consider the full life cycle of the chemical, even if not all pathways will be evaluated in the risk assessment, and that all susceptible populations should be considered. EPA also recommends that interested parties describe whether aggregate and/or sentinel exposures were considered and the basis for that consideration. The process of allowing externally produced risk evaluations to be considered by EPA is a novel aspect of the 2016 Lautenberg Chemical Safety for the 21st Century Act (LCSA) amendment to TSCA. It provides a new avenue for stakeholder-initiated actions that can influence the agency’s agenda for developing risk evaluations of existing chemicals.
Although there is no comment period for the guidance, EPA states that external parties can submit comments to the docket (EPA-HQ-OPPT-2017-0314) at any time to strengthen the guidance. Interested parties can also contact EPA at TSCAfirstname.lastname@example.org with questions on the guidance or for plans to submit draft risk evaluations.
Please contact us if you have questions about how to comment on the guidance or whether a draft risk evaluation may be useful for your business. Throughout this week, Gradient is providing additional alerts on EPA’s TSCA-related rulemaking and document releases and highlighting opportunities for stakeholder involvement.
Lisa A. Bailey, Ph.D., Senior Toxicologist
Lorenz R. Rhomberg, Ph.D., ATS, Principal
Rosemary Mattuck, M.S., Senior Environmental Engineer
Gradient is an environmental and risk sciences consulting firm renowned for our specialties in Toxicology, Epidemiology, Risk Assessment, Product Safety, Contaminant Fate and Transport, Industrial Hygiene, Geographic Information Systems, and Environmental/Forensic Chemistry. We employ sound science to assist national and global clients in resolving their complex problems relating to chemicals in the environment, in the workplace, and in consumer products.