On July 20, 2017, EPA published in the Federal Register two final rules intended to begin implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), which significantly reformed the Toxic Substances Control Act (TSCA). The two final rules are the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act, 82 Federal Register 33753 (Prioritization Rule) and Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act, 82 FR 33726 (Risk Evaluation Rule). A third TSCA framework rule—the TSCA Inventory Notification (Active/Inactive) Requirements rule (Inventory Rule)—has not yet been published in the Federal Register, although a pre-publication version was released in June 2017 (we previously reported on all three proposed rules here). Together, these three rules will help the Agency implement the extensive reforms set out in motion by the Lautenberg Act.
The Prioritization Rule and the Risk Evaluation Rule will become effective on September 18, 2017. Upon publication of the Active/Inactive Final Rule in the Federal Register – which EPA has indicated will become effective upon publication – a 180-day clock will be triggered for affected manufacturers, and affected processors must comply within 420 days of publication.
Finally, EPA published the notice of availability of Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations, a guidance document intended to assist stakeholders with developing and submitting their draft risk evaluations, and has uploaded draft scoping documents for the first ten chemicals for which EPA is required to perform risk evaluations under the Lautenberg Act to its website (EPA’s initiation of the risk evaluation for these ten chemicals was previously discussed here).
Under the Lautenberg Act, EPA is required to establish a risk-based screening process and criteria to designate chemicals as High or Low-Priority Substances. The Prioritization Rule establishes this process. The rule incorporates the definitions of “High-Priority Substance” and “Low-Priority Substance” directly from the Act, and, as required by the Act, dictates that a substance be designated as a “High Priority substance” if, after an extension of the public comment period, “information remains insufficient to enable the proposed designation of the chemical substance as a Low-Priority Substance.” 40 C.F.R. § 702.9(e).
As a reminder, under the Lautenberg Act, the Agency is required to designate at least 20 High Priority and Low Priority substances within 3 years of the Act’s passage, with an additional 5 substances in each category within 5 years of enactment. And, EPA must select a sufficient number of candidates for priority designations from EPA’s 2014 Work Plan to ensure that, at any given time, at least 50 percent of risk evaluations being conducted by EPA are drawn from that list.
EPA indicates in the final rule that High- and Low-Priority designations will apply to a chemical substance as a whole, rather than to a specific use of that chemical substance, which is nominally consistent with the proposal. Nevertheless, the Agency does appear to seek additional flexibility to narrow the scope of its review by allowing itself to exclude certain “conditions of use,” stating that “this does not mean that in prioritization, EPA will necessarily consider every activity involving the chemical substance to be a ‘condition of use.’” 82 FR at 33755.
Other notable departures from the proposal include that (a) EPA has deleted the pre-prioritization provisions, instead indicating that it will develop a separate process for selecting candidates for prioritization, with more information to follow this fall, (b) substitutes will no longer be considered during the prioritization process, and (c) EPA has now shifted the screening review to occur after the initial public comment period, to increase the opportunity for stakeholders to provide input to the screening review. Finally, the Agency seeks to give the regulated community some comfort that chemical substances that have been newly added to the TSCA Inventory (through completion of the pre-manufacture review process) and those that have been identified as “inactive” on the TSCA Inventory are “less likely to be selected as early High-Priority candidates.” Id. at 33756.
As required by the Lautenberg Act, the final rule requires EPA to complete the prioritization process (from initiation to final priority designation) within nine to twelve months after EPA publishes a notice in the Federal Register identifying the chemical substance for prioritization, thereby initiating a 90-day public comment period.
Risk Evaluation Rule
Once chemical substances are designated as High-Priority, the Risk Evaluation Rule establishes the process EPA will follow to “determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator under the conditions of use.” 15 U.S.C. § 2605(b)(4)(A). The final Risk Evaluation Rule departs from the proposal, which had been issued by the previous Administration, in several ways.
In what some stakeholders are asserting is a significant departure from the proposal, EPA indicates in the final rule that it need not include all conditions of use in the scope of its risk evaluation, suggesting that intentional misuses, legacy uses (those not associated with ongoing or prospective manufacturing, processing, or distribution), and substances that appear as impurities or byproducts, among other uses, may not be included within the scope of a risk evaluation on a case-by-case basis. Yet, EPA states in the preamble that the Agency will always plan to “include an evaluation of the conditions of use that raise greatest potential for risk.” 82 FR at 33728.
In addition, the final rule adds a mechanism for EPA to finalize partial risk evaluations where the Agency has sufficient information to determine whether a chemical presents an unreasonable risk under particular conditions of use. This provision appears responsive to the regulated community by allowing the Agency to preempt state laws restricting a given use sooner than later when the Agency has sufficient information to conclude that a certain use of a given chemical does not present an unreasonable risk of harm.
Finally, the rule includes a definition of “best available science,” defining it as “science that is reliable and unbiased. Use of best available science involves the use of supporting studies conducted in accordance with sound and objective science practices, including, when available, peer reviewed science and supporting studies and data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data),” and goes on to list additional factors the Agency will consider in evaluating whether the information qualifies as “best available science.” 40 C.F.R. § 702.33. Notably, EPA declined to codify some relevant definitions (including “sufficiency of information” and “unreasonable risk”), but the Agency has stated it will provide further information on applicability of these terms and their meaning in later guidance documents.
As a reminder, under the Lautenberg Act, the risk evaluation process may not last more than three years, though a potential six-month extension may be granted in some circumstances.
TSCA Inventory Notification (Active/Inactive) Requirements
On January 13, 2017, EPA published a Proposed Rule entitled TSCA Inventory Notification (Active-Inactive) Requirements, 82 FR 4255 (Active/Inactive Rule). A pre-publication version of the final rule was released in June 2017, but as of the date of this post, the Final Rule has not yet been published in the Federal Register. According to EPA, the Active/Inactive Rule will “enable [it] to fulfill a statutory obligation to designate chemical substances on the TSCA Inventory as active or inactive in U.S. commerce.” While all of the recent rules will impact industry, the Active/Inactive Rule is likely to have the most immediate effect, since publication of the Final Rule in the Federal Register will start the clock on compliance with important 180-day and 420-day reporting deadlines.
According to the pre-publication notice, the final Active/Inactive Rule establishes a retrospective electronic reporting requirement (through submittal of a “Notice of Activity Form A”) for chemical substances on the TSCA Inventory that were manufactured (including those chemical substances that were imported) for nonexempt commercial purposes between June 21, 2006 and June 21, 2016. According to EPA, the active/inactive status will help inform the Agency’s prioritization of chemical substances for the risk evaluations described above.
Notably, the final Active/Inactive Rule provides three important exemptions for the required electronic notice, based on the theory that the Agency has already received adequate notice that the chemical substance was manufactured during the ten-year period in some other manner:
- Chemical substances for which a Chemical Data Report was submitted in either 2012 or 2016. These chemical substances will automatically be designated as “active.”
- Chemical substances added to the TSCA Inventory during the ten-year period through a Notice of Commencement (NOC) received by EPA during that period. These chemical substances will also be automatically designated as “active.”
- Chemical substances for which the manufacturer has evidence—in the form of a Central Data Exchange receipt—that EPA already received a Notice of Activity Form A for the substance from another manufacturer.
Manufacturers must make retrospective reports no later than 180 days after the rule is published in the Federal Register, while processors have 420 days following Federal Register publication (note that the 420-day notification period is longer than the 360-day period in the Proposed Rule).
In a departure from the proposal, EPA is no longer requiring that companies report the commercial activity type and the date range of manufacture as part of the required submittal.
In addition to explaining the active/inactive designation, the Final Rule also sets forth the logistics for submitting the notifications, potential exceptions from the notification requirements, and procedures for handling confidential business information (CBI). Most importantly, as required by the Lautenberg Act, the final rule emphasizes that companies must submit substantiation for CBI for substances listed on the confidential portion of the TSCA Inventory as part the retrospective submittal, otherwise the substance will be moved from the confidential to the public portion of the Inventory.
The final Active/Inactive Rule also sets forth procedures for companies to submit an electronic notice to EPA to notify the Agency of intent to manufacture a previously designated inactive chemical. The reporting requirement will begin on the effective date of EPA’s final active/inactive substance designations, which will occur once EPA publishes a new version of the TSCA inventory with the relevant designations. After that date, processors and/or manufacturers must submit prospective notifications no more than ninety days prior to reintroducing the substance into commerce (as opposed to the 30-day timeframe under the proposal). Processing or manufacturing a chemical substance that is labeled “inactive” before its designation has been prospectively changed to “active” is considered a TSCA violation. Notably, even if the intended manufacturing never occurs, the final rule does not require a submitter to revise or rescind its notice.
For questions related to these TSCA framework rules or the Lautenberg Act, please contact Angela Levin or Laura Boorman.