The cornerstone of the new Toxic Substances Control Act (TSCA) is EPA's Section 6(b)(4) mandate to review the risk of each existing chemical in commerce and to regulate its use where unreasonable risks are found. With approximately 86,000 different substances on EPA's TSCA Inventory, completing these risk evaluations will require significant effort over many years. The new screening and risk evaluation prioritization process required by Section 6(b)(1) provides one means for EPA to focus its resources on the chemicals in this pool presenting the most significant current risks (e.g., identifying and deferring action indefinitely on particular "low-priority" chemicals unlikely to present an unreasonable risk). A second means to keep EPA concentrated on significant current risks rests in the new TSCA Inventory "reset" process in Sections 8(b)(4)-(6).
As described further below, the reset will relieve EPA from the need to prioritize or potentially evaluate any "inactive" chemical not manufactured, imported, or processed in the United States in the past ten years (June 2006). Given that, as of 2012, only approximately 7,700 chemicals from the TSCA Inventory were reported to be in active use in quantities greater than 25,000 lbs/year at any location, there is good reason to believe that the Inventory reset will dramatically reduce the number of chemicals to be prioritized. Companies that in the future wish to manufacture, import, or process a chemical designated as "inactive" for a nonexempt commercial purpose, however, will be required to first notify EPA. This presents potential new regulatory compliance risks for all chemical users, which all companies should anticipate and plan for. The new TSCA implements the Inventory reset by directing EPA to issue a rule requiring each chemical manufacturer and importer (and potentially processors) to notify EPA of each chemical on the TSCA Inventory that it has manufactured, imported, or processed in the past ten years. TSCA Section 8(b)(4)(A). Chemicals reported in this way will be designated as "Active Substances." As a start, EPA will designate all chemicals reported in the 2012 Chemical Data Reporting (CDR) period (40 C.F.R. Part 711) as Active Substances. TSCA Section 8(b)(6). Chemical substances listed on the TSCA Inventory but not reported as "active" (manufactured or processed in the prior ten years) will be deemed "Inactive Substances" and, once designated, it will be illegal to manufacture, import, or process them until after notice is given to EPA. TSCA Section 8(b)(5)(B). Records documenting rule compliance will be required to be maintained for five years.
EPA is required to promulgate a final rule implementing the Inventory reset by no later than June 2017. The rule will require all Active Substance notices to be submitted within six months thereafter (i.e., by approximately December 2017). EPA will then publish an updated TSCA Inventory identifying each substance as either "active" or "inactive." Submitters will be allowed to claim that the particular chemical identity of an Active Substance is confidential business information (CBI) to prevent public disclosure; however, the claim will be honored only if the identity is already confidential on the current TSCA Inventory and if the CBI claim can be adequately substantiated.
EPA currently plans to issue a proposed Inventory reset rule for public comment in December 2016. EPA has the option to include chemical processors in the mandatory reporting program, but may also make their participation optional. It is currently uncertain what measures the proposal may include to avoid unnecessary or duplicative reporting (e.g., coordinated reporting through trade associations or phased reporting to minimize duplicative protective submissions) or whether the initial Inventory reset rule will include provisions addressing procedures for keeping active/inactive status designations current into the future as required by TSCA Section 8(b)(5)(A) (e.g., requiring periodic updates).
It is also unclear whether the initial Inventory reset rule will include specific procedures for providing notice to EPA to "reactivate" substances initially designated inactive. Beyond the general intent to start manufacturing or processing and any chemical identity CBI claims, the statute does not require any particular content for the notices and EPA does not approve them. Rather, the Agency is required to update a substance's status to "active" after a notice is received. TSCA Section 8(b)(5)(B)(iii). EPA has broad information collection rulemaking authority under Section 8, however, and it is possible that, as part of the "reactivation" process, EPA might, by rule, seek to require submission of reasonably ascertainable health and safety information concerning the Inactive Substance and its intended use to help the Agency screen the particular risks of these existing chemicals reentering the marketplace. If notice information provides cause for concern, it may be far simpler and faster for EPA to implement reasonable control measures for the Inactive Substance at this early stage, before the new use begins (e.g., proposing a significant new use rule under TSCA Section 5(a)(2)(ii)) and perhaps avoid or further defer formal prioritization or risk evaluation, which are much more burdensome processes for the Agency.
The Inventory reset is a useful tool to focus EPA risk evaluation resources on the most significant, current potential chemical risks; however, the initial reset process and compliance with notice obligations prior to manufacturing or processing chemicals deemed "inactive" present their own costs and risks. Given the potential due diligence and reporting burden, all companies should pay attention to the Inventory reset rulemaking as it evolves. Companies should start now to investigate and inventory their current and past nonexempt chemical manufacturing and processing. A complete listing of these substances will ensure compliance with the anticipated reporting obligation, and will also ensure that companies can continue to manufacture and use all chemical substances important to their operations without entering the currently uncertain "reactivation" notice process for any overlooked chemical or inadvertently violating the premanufacture notice obligation for substances designated "inactive." Downstream processors and users should do the same. Even if they technically are not required to report, they should take steps to ensure that all substances important to their operations are designated as "active," either reporting themselves (if the final rule allows) or ensuring that their suppliers have reported the substances. Starting internal chemical reviews now also will surface any practical difficulties that can arise in the process and evaluation of potential solutions and can provide the basis for targeted, effective, and timely participation in the Inventory reset rulemaking proceeding to shape the rule to avoid or minimize those problems.
This may be a particularly auspicious time to start an internal "active" chemical identification review as it coincides with the 2016 CDR reporting period and involves a similar investigation process and will raise many of the same technical, legal, and practical issues (e.g., identifying which byproduct and inadvertently manufactured substances must be reported, nomenclature uncertainties, and chemical identity uncertainties in imported mixtures). Given that EPA will include automatically all 2012 CDR chemicals on the Active Substance list, the focus for future Active Substance notifications can be on those substances manufactured, imported, or processed in quantities below the applicable CDR reporting thresholds (25,000 or 2,500 lbs/site) or subject to other CDR reporting exemptions.
This article was originally published in the ABA's Section of Environment, Energy and Resources newsletter in September 2016.