Implementation of the newly amended Toxic Substances Control Act (TSCA), signed into law last June, is in full swing. The U.S. Environmental Protection Agency (EPA) has been working hard to meet statutorily imposed deadlines for promulgating three “framework” rules by June 2017. To date, the EPA is on target. This column discusses the three framework rules.
TSCA Inventory Notification
The recent TSCA amendments require the EPA to designate TSCA Inventory substances as active or inactive in U.S. commerce. On January 13, 2017, the EPA published a proposed rule that would require an electronic notification for chemical substances listed on the TSCA Inventory that were manufactured (including imported) for non-exempt commercial purposes during the 10-year time period ending on June 21, 2016. The EPA also would accept such notices for chemical substances that were processed. The agency would then use these notifications to distinguish between active and inactive substances for prioritization reviews and include the active and inactive designations on the TSCA Inventory.
The EPA also proposes to establish procedures for forward-looking electronic notification of chemical substances on the TSCA Inventory that are designated inactive, if and when the manufacturing or processing of such chemical substances for non-exempt commercial purposes is expected to resume. Upon receipt of a valid notice, the designation of the pertinent chemical substance would be changed on the TSCA Inventory from inactive to active. The proposed rule includes procedures to submit Notices of Activity (NOA) both for the retrospective (Inventory reset) and forward-looking (activation) activity notifications, the details of the notification requirements, exemptions from such requirements, and procedures for handling claims of confidentiality. Comments were due March 14, 2017.
The EPA proposed on January 17 procedures to establish the risk-based screening process and criteria it will use to identify chemical substances under TSCA as either high-priority substances for risk evaluation, or low-priority substances for which risk evaluations are not warranted at the time. The proposed rule describes the processes for identifying potential candidates for prioritization, selecting a candidate, screening that candidate against certain criteria, formally initiating the prioritization process, providing opportunities for public comment, and proposing and preparing final priority designations.
The EPA notes that prioritization is the initial step in a new process of existing chemical substance review and risk management activity established under recent TSCA amendments. The agency incorporated all of the elements required by the new TSCA, but also supplemented those requirements with additional criteria it expects to consider, some clarifications intended to provide greater transparency, and additional procedural steps to ensure effective implementation. Comments on the proposed rule were due March 20, 2017.
Risk Evaluation Process
On January 19, the EPA proposed a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, including a potentially exposed or susceptible subpopulation, under the conditions of use. The process doesn’t consider costs or other non-risk factors. Risk evaluation is the second step, after prioritization, in a new process of existing chemical substance review and management established under the new TSCA. The proposed rule identifies the steps of a risk evaluation process including scope; hazard and exposure assessment; risk characterization; and a risk determination. The EPA proposes this be used for the first ten chemical substances to be evaluated from the 2014 update of the TSCA Work Plan for Chemical Assessments, chemical substances designated as high-priority substances during the prioritization process, and those chemical substances for which the EPA has initiated a risk evaluation in response to manufacturer requests. The proposed rule also includes the required “form and criteria” applicable to such manufacturer requests. Comments were due March 20, 2017.
The EPA staff is to be commended for proposing these regulations on a timely basis, and working hard to implement the new law. Many stakeholders are expected to comment on the proposals, as they truly are foundational to the entire domestic chemical management program and their promulgation will have lasting implications for years to come.
LYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at email@example.com
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006).