On June 22, 2017, the U.S. Environmental Protection Agency (EPA) fulfilled one of its key statutory obligations under the 2016 federal Toxic Substances Control Act (TSCA) reform law by issuing three final TSCA “framework” rules. These new rules consist of:
- A TSCA Inventory “reset” rule;
- A “prioritization” rule identifying EPA’s criteria and procedures for designating existing chemical substances as either “high-priority” or “low-priority” for evaluation against TSCA’s “unreasonable risk” standard; and
- A rule establishing the Agency’s formal risk evaluation process for assessing high-priority chemical substances.
To support its ongoing TSCA implementation efforts, EPA also issued new non-binding regulatory guidance for conducting chemical risk evaluations that chemical manufacturers may use to assess existing chemicals. Finally, the Agency published a set of initial “scoping documents” for the first group of ten (10) existing chemicals already undergoing EPA risk evaluation (including, for example, asbestos, trichloroethylene, perchloroethylene and 1,4-dioxane); EPA further reported that it plans to publish for public comment draft “formulation documents” for these ten chemicals late this year. Brief summaries of EPA’s final rules are provided below.
TSCA Inventory Reset Rule. This rule is intended to allow EPA to update the current TSCA Inventory by designating the more than 85,000 chemicals currently listed on the Inventory as either “active” or “inactive” in the domestic U.S. market.
- Under the final rule, EPA is requiring companies to file electronic notifications providing the specific identities and certain related information for chemicals that they manufactured and/or imported in non-exempt commercial quantities in the U.S. during the ten-year time period from June 21, 2006 through June 21, 2016. Chemical processors are not affirmatively required to file such notifications under the rule, but may do so on a voluntary basis. All chemicals covered by these notifications will be designated as “active” substances on the Inventory.
- Substances for which EPA receives no such notifications will be deemed “inactive.” Any party wishing to manufacture or process an “inactive” chemical will be required to file a prospective notification with EPA at least 90 days prior to commencing manufacture/processing.
- Affected companies will have 180 days from the date of final publication of EPA’s rule to submit the required notifications, using a standardized electronic form at the Agency’s Central Data Exchange (CDX). However, companies potentially may be able to take advantage of certain reporting exemptions and/or rely on CDX notifications made by other parties in lieu of submitting their own forms, so careful review of the rule’s specific provisions is recommended.
Prioritization Rule. EPA’s new prioritization rule establishes criteria and 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” typically would not. Consistent with this distinction, EPA’s rule calls for the Agency to analyze the existing available information for particular chemicals, starting with those substances that have already been identified in EPA’s 2014 Update to its TSCA Work Plan.
- Once EPA selects a chemical for prioritization review, the Agency would formally initiate the prioritization process by publishing a notice in the Federal Register, and then it would have between nine (9) and twelve (12) months to conclude its analysis, ending with a formal determination designating the chemical as either high- or low-priority.
- As part of this process interested parties would be afforded two separate chances to submit public comments: (1) in response to the initial Federal Register notice initiating the prioritization review; and (2) in response to EPA’s proposed designation of the chemical as either high- or low-priority.
- Each chemical formally designated as “high-priority” would then be immediately subject to a formal EPA risk evaluation process, employing the technical steps and considerations outlined in the rule described below.
Risk Evaluation Rule. EPA’s third rule establishes 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 specified under the rule includes several key components, consisting of (1) an initial scoping step, in which EPA will identify the hazards, exposures, conditions of use and potentially exposed or susceptible subpopulations the Administrator expects to consider, (2) a hazard assessment, (3) an exposure assessment, (4) a risk characterization, and (5) a final risk determination as to whether the chemical substance, under the conditions of use, presents an unreasonable risk.
- In the final rule EPA stated that when evaluating the “conditions of use” for a particular chemical it will consider - as required by TSCA’s statutory definition of this term, the “circumstances ... under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used or disposed of.” Nevertheless, EPA clarified that its risk evaluations may not necessarily consider all potential uses such as, for example, those that are deemed to involve “de minimis” risks. Rather, EPA said it would ensure that its risk evaluations consider all conditions of use posing the greatest concern or potential for risk. This potential limitation on the scope of EPA’s analysis has already come under criticism from some nongovernmental organizations, and could be the subject of potential challenges to the final rule.