Commercializing a New Chemical
EPA was challenging the safety of a new chemical proposed for use in a seasonal line of high-performance professional products. The new chemical was a more environmentally benign replacement for a previously used chemical that was under intense scrutiny by EPA. EPA had general concerns about the safety of the broader chemical class and was treating the new formulation as if it were the same as the more hazardous legacy material.
We conducted a detailed review of the toxicology of the new chemical and addressed EPA’s concerns by applying best practices to identify the highest-quality studies, evaluate appropriate endpoints, and account for uncertainties. We coupled this approach with a refined exposure assessment that reflected usage in the U.S. market, rather than the overseas market EPA had considered.
We helped our client respond rapidly to EPA’s concerns, thereby avoiding any delays in getting the product to market in time for the next season. At the same time, we were able to provide the data EPA needed to meet its commitment to public safety while facilitating commercial innovation.