Posted on July 7, 2016 by Lynn L. Bergeson
Toxic Substances Control Act (TSCA) legal practitioners and every American interested in chemical safety celebrated President Obama’s signature Wednesday, June 22, 2016, of H.R. 2576, the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The bill extensively amends TSCA, the federal chemical management law, and President Obama’s signature made the Act immediately effective. The amendments go a long and comforting way in fixing what was wrong with TSCA, and empower the U.S. Environmental Protection Agency (EPA) to identify and manage chemical risks more efficiently and effectively.
EPA wasted no time in beginning the challenging task of implementing the new law, and on June 22, rolled out a web page on the new law. EPA’s web page includes links for users to access: the text of the new law; answers to frequently asked questions (FAQ) on the new law; a brief summary of the provisions found in the new law; and Administrator McCarthy’s blog post — TSCA Reform: A Bipartisan Milestone to Protect Our Health from Dangerous Chemicals.
On the whole, the new TSCA is vastly improved and, if implemented smartly, will make good on fulfilling the promise to make TSCA a truly muscular law that ensures chemical safety and public health. While there are many, many implications of the law’s enactment, its most immediate effect will be on the new chemicals review process. Under old TSCA, entities wishing to bring a new chemical or significant new use of an existing chemical (new chemical) to market submitted a notification and, if the 90-day review period lapsed without notice from EPA, commercialization could occur as permitted under the conditions of the notification. Speed to market and predictability are critical to innovation and business equilibrium. Under new TSCA, EPA must make one of three affirmative determinations: (1) that the new chemical presents an unreasonable risk; (2) that there is insufficient information on the new chemical to decide, or, in the absence of sufficient information, that it may present unreasonable risk, or that the substance is produced in substantial qualities and can be expected to enter the environment or pose substantial exposure risks; or (3) that the new chemical is not likely to present an unreasonable risk.
For new chemicals in the review process on June 22, TSCA Section 26 gives EPA discretion to apply old TSCA to pending notifications not yet “dropped” from EPA review. Importantly, EPA has interpreted this provision and notes on its new webpage “[f]or companies that submitted premanufacture notices (PMNs) prior to enactment and which are currently undergoing review, the new law effectively resets the 90-day review period. The agency will make every effort to complete its review and make a determination within the remaining time under the original deadline. EPA will be making additional information available on new chemical reviews in the very near future.”
EPA has the discretion to proceed in this way, but a preferred interpretation would have been to continue to apply the old TSCA provisions to pending cases for some time period into the future. While clarity is welcomed, the more flexible alternative reading would have allowed for a smoother and more measured transition. The take away here is that pending notifications will have their 90-day clocks reset (it is not entirely clear from what date the clock restarts), and submitters will need to recalibrate their delayed commercialization trajectory accordingly. More information is available in the Bergeson & Campbell, P.C. (B&C®) memorandum TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA and in the new B&C blog TSCAblog.com.
Tags: TSCA