EDF Health

New Approach Methodologies Should Adhere to TSCA Standards

By Susanne Brander, PhD, Senior Contributing Scientist / Published: August 15, 2023

What’s New?

EPA recently asked its Board of Scientific Counselors (BOSC), comprised of experts in the fields of toxicology and environmental chemistry, to make recommendations on implementing new approach methods (NAMs) for testing the safety of new chemicals.

NAMs encompass a wide array of new evaluation strategies, including testing cell lines or invertebrates (rather than mammals); using computational approaches; and estimating potential harms of new chemicals by looking at existing toxicity data on similar substances.

Why It Matters

EPA announced in 2019 that it would be redirecting resources towards developing NAMs to replace those studies. The looming concern is the possibility that NAMs may miss effects that whole animal mammalian testing accounts for and generate false negatives — potentially allowing toxic chemicals to appear in consumer products or end up in our environment.

This could happen because relying only on NAMs or using data from one chemical to predict how a new one might behave opens the door to missing negative effects. NAMs could also cause evaluators to miss opportunities to use the Toxic Substances Control Act (TSCA), the nation’s primary chemical safety law, to limit toxic chemical exposures. Read More »

Also posted in Chemical regulation, Cumulative risk assessment, Emerging science, Emerging testing methods, Frontline communities, Health science, Risk assessment, Risk evaluation, TSCA / Tagged , , | Authors: / Comments are closed

EPA’s new Collaborative Research Program – A step toward improving new chemical reviews under TSCA

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: May 16, 2022

Maria Doa, Ph.D., Senior Director, Chemicals Policy; Lauren Ellis, MPH, Research Analyst; and Lariah Edwards, Ph.D., Post-Doctoral Fellow 

The Environmental Defense Fund (EDF) recently filed comments on EPA’s Toxic Substances Control Act (TSCA) Collaborative Research Program to Support New Chemical Reviews (Collaborative Research Program). The Collaborative Research Program is a multi-year scientific partnership between the agency’s Office of Pollution Prevention and Toxics (OPPT) and Office of Research and Development (ORD) aimed at modernizing the methods, approaches, and tools used to evaluate new chemicals under TSCA.  

We strongly support OPPT’s collaboration with ORD, which has a breadth of scientific expertise across EPA’s different research programs. As such, ORD will help OPPT implement the best available science in its new chemical assessments, which should ultimately prevent risky chemicals from entering the marketplace. We urge OPPT to use this opportunity – and ORD’s expertise – to improve and expand its consideration of new chemical impacts to frontline communities, the risks new chemicals may pose throughout their entire life cycle, as well as cumulative risks from chemicals that may cause similar health effects. 

Below we outline the five proposed research areas for new chemicals under the Collaborative Research Program and our comments on each. All five can have an important impact on EPA’s new chemical assessments and consequently on EPA’s determination on whether a new chemical is expected to present an unreasonable risk.  Read More »

Also posted in TSCA reform / Tagged , , | Authors: / Comments are closed