Keller and Heckman LLP and Cardno ChemRisk present a webinar series on the changes to the Toxic Substances Control Act (TSCA) resulting from the June 22, 2016 passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.
October Topic: PMN Review and Review Period Issues
Section 5 of TSCA has changed! Before a new substance is allowed onto the market EPA must now make "an affirmative finding of safety" under a new risk-based safety standard. EPA must also consider “conditions of use,” and “potentially exposed or susceptible subpopulations," but not cost, availability of alternatives, or other non-risk factors. Since the changes in the law, many new substances will be cleared only after issuance of section 5(e) orders, which may impose restrictions on manufacture / import volume, water release, and occupational safety and health practices. As before, the Agency will make conservative assumptions in predicting toxicity and exposure, necessitating a more strategic approach to PMN management and chemical risk assessment including identification of existing data and more accurate descriptions of applications and uses, and filling data gaps using read-across approaches or development of new toxicological data. Topics included:
Click here to listen to the webinar.