On June 22, 2016, President Barack Obama signed H.R. 2576, the TSCA reform bill passed by Congress, into law.
The “Frank R. Lautenberg Chemical Safety for the 21st Century Act” is effective upon enactment, and therefore will affect currently pending actions (new chemical submissions, regulatory decisions, and “Work Plan” risk assessments). The new law contains detailed timelines for implementation, primarily related to launching the cornerstone provision of the new law under which the Environmental Protection Agency (EPA) is provided broad authority to prioritize, review, and regulate “existing” chemicals in U.S. commerce. Enforceable deadlines are provided for by statute to keep programs operating at specified paces. Other highlights of the new law include:
- Industry identification of “active” substances in U.S. commerce
- Prioritization of active substances into high- and low-priority substances
- Agency-driven process for reviewing grandfathered chemicals, with a minimum, measured, regulatory pace
- Risk-based safety standard evaluated under conditions of use prohibiting consideration of costs or other non-risk factors and requiring consideration of potentially exposed or susceptible subpopulations
- No lock-step information requirements, with alternative testing playing a central role
- Science-based risk assessments
- Broad agency authority to regulate, but requiring EPA to consider alternatives in bans and phase-outs
- Preservation of confidential business information (CBI), substantiation required in many cases, with more liberal disclosure authority and need to renew many claims every 10 years
- Industry to pay a portion of the cost of Agency chemical reviews
The Agency’s announcement of the legislation and some of its immediate implications can be found at this link: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act.