Toxicity Testing under TSCA Reform

Posted on Behalf of  Michael Ierardi, Marisa Kreider

With the promulgation of TSCA Reform, EPA has expanded authority to request toxicity testing and evaluation of new and existing chemicals in commerce to fill important data gaps and needs, resulting in increased burden on industry to sponsor and manage animal testing studies.  Such testing could be used to fill important data gaps regarding hazard for chemicals under evaluation or clarify assumptions made regarding hazard based on read-across from analogs.

We encourage companies to anticipate U.S. EPA’s testing requests for their inventory chemicals by:

· Knowing what data is and is not available for specific chemicals, both publically (peer-reviewed literature, government documents, etc.) and privately (in-house);

· Comparing chemical structures with the 56 Chemical Categories already identified by U.S. EPA and identifying key toxicity endpoints for the relevant categories;

·  Understanding potential analogs of chemicals of interest and their associated toxicities; and

·  Understanding potential use scenarios to predict relevant exposure pathways

By proactively complying with TSCA Reform toxicity testing requirements, companies can likely expect shorter turnaround times with U.S. EPA submissions, an advanced understanding of potential risks, and more control over their testing timescale. Otherwise, should companies choose to wait for a formal request from U.S. EPA, there could be delays with submission processes, limited time for execution of time-sensitive studies, and challenges with limited capacity at proficient laboratories. By working in tandem with our clients and taking their needs into consideration, Cardno ChemRisk can assist with selecting the proper route of toxicity testing for their specific chemicals that will satisfy regulatory requests.

We expect that toxicity testing requests under TSCA may include:

· Mammalian toxicity testing;

·  Ecotoxicity testing (all trophic levels); and/or

·  Physical chemical properties predictive of toxicity

To learn more about how Cardno ChemRisk can assist with such request, please contact Dr. Marisa Kreider.