On August 11, 2017, the U.S. Environmental Protection Agency (EPA) published the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements. This final rule is now in effect. Here is why the rule is important, and what stakeholders should be doing to protect their interests.
Under the old TSCA, the list of chemicals believed to be in commerce and listed on the TSCA Chemical Inventory was widely viewed as misleading. While the chemicals listed on the Inventory (accessible at www.epa.gov/tsca-inventory) at one point may have been commercially active, it has long been thought that many of the 85,000 or so listed chemicals were no longer in use. Under the new TSCA, Congress authorized the EPA to “reset” the Inventory by distinguishing between active and inactive substances. By so doing, the EPA and the public would obtain a clear subset of chemicals in use in the U.S. and on which the EPA could focus its efforts to prioritize substances for risk evaluation and risk mitigation purposes.
The final TSCA Inventory notification rule establishes a retrospective electronic notification of chemical substances listed on the TSCA Inventory that were manufactured (or imported) for nonexempt commercial purposes during the 10-year time period ending June 21, 2016, with provision to also allow notification by processors. The EPA will use these notifications to distinguish active substances from inactive ones. The EPA states that it will include the active and inactive designations on the TSCA Inventory and as part of its regular publications of the Inventory.
The final rule also establishes procedures for forward-looking electronic notification of chemical substances listed on the TSCA Inventory that are designated as inactive, if and when the manufacturing or processing of such chemical substances for nonexempt commercial purposes is expected to resume. On receiving forward-looking notifications, the EPA will change the designation of the pertinent chemical substance listed on the TSCA Inventory from inactive to active. The final rule establishes: the procedures regarding the manner in which such retrospective and forward-looking activity notifications must be submitted; the details of the notification requirements and related exemptions; and the procedures for handling claims of confidentiality.
Chemical manufacturers and importers are required to submit notifications for chemicals that were manufactured or imported over the 10-year look-back period. Pursuant to the rulemaking, the retrospective reporting period for manufacturers begins on August 11, 2017, and ends on February 7, 2018. The submission period for processors also begins on August 11, 2017, but processors have until October 5, 2018, to submit retrospective activity notifications.
For the retrospective reporting period, manufacturers must provide chemical identity information and indicate whether they seek to maintain an existing claim for protection against disclosure of a confidential business information (CBI) chemical identity, if applicable. The EPA states processors that choose to report (although not a requirement) must provide chemical identity information and whether they seek to maintain an existing claim for protection against disclosure of a CBI chemical identity, if applicable. The EPA removed the proposed requirements to report commercial activity type and date range, as these were deemed unnecessary.
The EPA has promulgated a thoughtful final rule; it carefully reviewed its statutory obligations, the many comments on the proposed rule, and balanced the various interests with the EPA’s resources. The agency made a number of significant changes from the proposed rule, all of which improved the clarity of the final rule.
It’s important that chemical manufacturers carefully review their operations and ensure active substances are properly identified as such during the reporting period. Companies need to identify the chemicals they manufactured or imported during the look-back period to assess their compliance obligations. Similarly, chemical processors and others reliant upon supply chain relationships should communicate and work with their suppliers to avoid any disruption as a result of the Inventory notification process.
LYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at firstname.lastname@example.org
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).