The U.S. Environmental Protection Agency (EPA) recently issued three significant proposed rules for implementing key mandates under the 2016 federal Toxic Substances Control Act (TSCA) reform law. These proposals collectively represent a major step in EPA’s efforts to update its chemical reporting and risk assessment activities under TSCA, and involve the following key topics: (1) a TSCA Inventory update rule; (2) a rule identifying the criteria and procedures that EPA will use for designating chemical substances as either “high-priority” or “low-priority” for evaluation against TSCA’s “unreasonable risk” standard; and (3) a rule establishing the Agency’s formal risk evaluation process for assessing high-priority chemical substances. We have outlined below some of the key issues of potential concern with each rule that may warrant industry attention and/or comment.
TSCA Inventory. As required under the 2016 TSCA reform legislation, the TSCA Inventory rule is intended to enable EPA to designate the more than 85,000 chemicals currently listed on the TSCA Inventory as either active or inactive. Under the proposal, chemical companies would be required to notify EPA with the specific chemical identities of the substances they manufactured, processed and/or imported in the U.S. within the past 10 years; substances not in use within the past 10 years would be deemed “inactive.” However, EPA is proposing to require new notifications only for chemical substances that have not already been identified in company submissions under the pre-existing 2012 and 2016 Chemical Data Reporting rule requirements. EPA is also seeking public comment about the appropriate mechanisms to be used for submitting the required notifications, including whether the Agency should rely on existing chemical reporting tools such as the EPA Central Data Exchange or Chemical Information Submission System, or other potential alternatives.
Prioritization Process. Separately, EPA has proposed a rule to establish specific procedures for prioritizing which chemical substances are subject to formal TSCA risk evaluation. Under the revised TSCA law, any chemical designated as “high-priority” must undergo risk evaluation, while chemicals designated as “low-priority” need not (and would generally be unregulated under TSCA). As part of an initial “pre-prioritization” step, the Agency has proposed to identify candidates for possible “high-priority” status based on consideration of any of nine separate screening criteria, including whether the substance is persistent, bioaccumulative or toxic, is used in children’s products, has high acute or chronic toxicity, or exhibits a potential exposure or hazard to human health or the environment. In contrast, candidates for possible classification as “low-priority” may include chemicals already designated on EPA’s Safer Chemical Ingredients List, or other substances that the Agency considers to be unlikely to pose an unreasonable risk of injury to health or the environment. This initial screening step would conclude with EPA’s selection of certain candidate substances to be carried forward into the formal prioritization process.
Later stages of the process under EPA’s proposal would include (1) formal initiation of prioritization for the selected substances, (2) proposed designation as either high- or low-priority, and (3) final designation of priority. According to the Agency, chemicals entering the formal prioritization process will generally be only those for which EPA believes sufficient data already exist to allow it to prioritize and perform risk evaluations; however, EPA has clarified that it plans to use its full TSCA authorities to require industry to perform chemical testing and additional data-generation as deemed necessary by the Agency - including potentially to assist with prioritization. As required under the statute, EPA would provide two 90-day public comment periods, first when the Agency formally proposes to initiate prioritization for a specific chemical substance (or categories of substances), and second, when EPA actually proposes to designate a substance (or category) as “high-priority” or “low-priority.” The Agency’s decision to designate a substance as “high-priority” would be based on EPA’s analysis of the public comments received and all other available data; significantly, the Agency has clarified that “high-priority” status will be the default option for any substance once it has entered the prioritization process. In other words, if EPA finds that the available data are insufficient to designate the substance as “low-priority” then the Agency will designate it as “high-priority” for risk evaluation.
Risk Evaluation Procedures. Finally, EPA is also proposing a rule establishing a risk evaluation process to determine whether high-priority chemical substances pose an unreasonable risk of injury to health or the environment. The risk evaluation process follows the prioritization review and is proposed to include a hazard assessment, an exposure assessment, a risk characterization, and a risk determination. The proposal includes opportunity for public participation in risk evaluation process, and specifically requests comment on whether EPA should provide for additional transparency and public participation.
The proposed risk evaluation rule does not provide a specific definition for “unreasonable risk,” although EPA is soliciting comments as to whether a definition and list of factors should be included in the final rule. Importantly, the TSCA reform legislation expressly prohibits EPA from considering cost as a factor at the risk evaluation stage, so any such definition could not include cost factors. With respect to the statutory mandate that EPA evaluate the risk of a chemical to “potentially exposed or susceptible subpopulations,” EPA is expanding on the statutory language by proposing that it may choose to identify specific subpopulations in addition to those expressly identified by the statute (i.e., in addition to infants, children, pregnant women, workers or the elderly). Finally, the proposal contains several key changes to EPA’s prior TSCA risk assessment process. One such change is that going forward EPA will conduct risk evaluations to encompass all known, intended, and reasonably foreseeable activities related to a particular chemical substance, rather than conducting risk assessments on specific uses.
Comments on the Proposed Rules. Public comments on EPA’s TSCA Inventory rule must be filed by March 17, 2017, and public comments on EPA’s prioritization process rule must be filed by March 20, 2017. However, the proposed rule on risk evaluation has not yet been published in the Federal Register; once published interested parties will have 60 days in which to submit public comments to EPA.