Thank you to my colleague, Emilee Mooney Scott, for this post. Emilee focuses her practice on chemicals and hazardous materials regulation and is counsel in our Environmental & Utilities Practice Group.
As we previously outlined, the Toxic Substances Control Act (“TSCA”) was amended in 2016 to provide EPA with much broader authority to regulate “existing” chemical substances (i.e., those that are already in use in commerce). While EPA has met its statutory deadlines thus far, several critical deadlines are looming in 2019. EPA’s progress toward its 2019 deliverables has been delayed by the recent government shutdown and redeployment of resources.
Risk Evaluations and Prioritizations Expected in 2019
TSCA requires EPA to systematically review selected substances that are already active in commerce through a three-step process of prioritization, risk evaluation, and risk management. The prioritization step identifies chemical substances that may pose an unreasonable risk of injury to health or the environment and designates them as “high priority” for further study. Those high priority substances are then subjected to a risk evaluation step to determine whether they do indeed pose an unreasonable risk of injury to health or the environment. Substances that do pose an unreasonable risk must then be subject to a risk management rule to mitigate such risks, though, for example labeling or work practices requirements.
The 2016 TSCA amendments directed EPA to identify a slate of ten substances that would skip the prioritization step and proceed directly to the risk evaluation step. Those first ten substances were identified in late 2016, and risk evaluation problem formulations were released in the summer of 2017. Since then, risk evaluations have been underway. Final risk evaluations are due for the first ten substances by December 19, 2019 (subject to possible six-month extension), so draft risk evaluations must be published by October 20, 2019 to allow for the required sixty-day comment period.
EPA released its first draft risk evaluation under amended TSCA in November 2018, concluding that Pigment Violet 29 does not pose an unreasonable risk to human health or the environment. EPA was expected to release the rest of the first ten draft risk evaluations this winter to allow ample time for public comment and agency reevaluation. At a conference this week, Alexandra Dunn, assistant administrator for the Environmental Protection Agency’s Office of Chemical Safety and Pollution Prevention, said that the remaining draft risk evaluations are instead expected this summer.
Earlier this week, the U.S. Government Accountability Office (GAO) released a report detailing some of the factors that have led to EPA’s slower than anticipated progress. Internal EPA discussions about priorities for the Integrated Risk Information System (IRIS) have led to delays, and amended TSCA places a significantly increased workload on the relevant office of EPA. The fast timelines imposed by the TSCA amendments have also required EPA to begin implementing the law before internal guidance and procedures are fully in place. According to GAO, EPA officials “likened it to building an airplane as they fly it.” Several of EPA’s rules implementing TSCA amendments have been challenged in court, and depending on how the challenges are resolved, additional delays could result. The government shutdown in late 2018 and early 2019 also delayed EPA’s efforts.
EPA has a significant amount of work ahead of it—dozens of TSCA-related deliverables are due at the end of 2019. In addition to the final first ten risk evaluations being due by December 19, 2019, by December 22, 2019 EPA is required to ensure that at least twenty risk evaluations on high-priority substances are underway, and must designate an additional twenty substances as low-priority.
Update to TSCA Inventory
EPA has already achieved one of its most anticipated 2019 milestones: release of the revised TSCA Inventory. The TSCA Inventory is a list, maintained by EPA, of all the existing chemicals in commerce. If a substance is not listed on the TSCA Inventory it is considered “new” and subject to review before it is introduced into commerce.
In connection with the 2016 amendments to TSCA, EPA was required to revise the TSCA inventory and cull the substances that exist but are not active in commerce. EPA’s review of the TSCA inventory was informed by reporting by manufacturers and importers in 2012 and 2016, and by “Notice of Activity” forms submitted by manufacturers, importers, and processors of chemical substances in 2018.
In February 2019, EPA released the revised TSCA inventory. Of the 86,228 substances on the TSCA inventory, only 40,655 were identified as active in commerce. If there are any substances marked inactive on the revised TSCA inventory, but which are still being manufactured, imported or processed, manufacturers/importers/processors have until May 20, 2019 (90 days from publication of the revised Inventory) to submit a Notice of Activity Form B (through the Central Data Exchange) to prevent the substance from being designated as inactive. Once a substance is designated inactive, it may not be re-introduced into commerce until EPA receives a Notice of Activity form alerting it to the re-introduction.