Course Description:
As companies innovate new technologies, one major hurdle that companies must clear before commercializing their products is to ensure their products are compliant to regulations in all targeted countries or regions where they will be sold. Most new chemical regulations require a basic set of tests to support a new chemical dossier submission, with exceptions for polymers in some countries and regions. The United States is the only country that does NOT require testing to accompany a submission for a new chemical. Since the passage of the Lautenberg Chemical Safety Act in 2016, the percentage of new chemicals being regulated under the Toxic Substances Control Act has increased significantly, and many premanufacture notice (PMN) cases can take nine to 12 months for review by the Environmental Protection Agency. Unfortunately, this makes it challenging for companies to plan their commercialization or market strategy. Many companies question whether testing would streamline the PMN review process. This session will highlight important considerations for a company prior to conducting tests for their PMN submission, including a strategy analysis of whether the time and cost of testing will affect the review outcome.

Contact Hours:
0.5 Contact Hour

Presentation Date:
09/28/2021

Presenters:
Shannon Gainey Ph.D., REACH24H USA Inc.
Robert Kiefer, REACH24H USA Inc.