TSCA Actions Expected to be Plentiful in 2023
The Toxic Substances Control Act (TSCA) promises to be the source of much regulatory activity in 2023 with more “whole chemical substance” risk determinations, risk management rules, updates to TSCA rules on confidentiality, and PFAS reporting expected. The expected activities are summarized below.
TSCA Risk Evaluation and Management Rule Status
At the end of 2022, EPA announced the availability of the final revision to the risk determination for carbon tetrachloride whereby it was found to present an unreasonable risk of injury to human health when evaluated under its condition of use. The carbon tetrachloride determination is the latest risk determination made in accordance with EPA’s June 2021 announcement that it would revisit the risk evaluations for the “first ten” high priority substances completed during the Trump administration. Like the previous revised risk determinations, the revised risk determination for carbon tetrachloride utilized a “whole chemical approach,” which at this stage does not differentiate between conditions of use and assumes that workers will not always wear the appropriate personal protective equipment. Industry groups have questioned whether these policy choices implemented as part of the revised risk determinations are consistent with TSCA, and legal challenges may be forthcoming. Nevertheless, additional final revised risk assessments using this approach, including for trichloroethylene, are expected in 2023.
In addition to the remaining risk determinations referenced above, EPA is expected to release several proposed Risk Management Rules to address the unreasonable risk of injury to health the agency has identified in the final risk evaluations. Proposed rules are anticipated in early 2023 for methylene chloride, perchloroethylene (PCE), trichloroethylene (TCE), carbon tetrachloride, and several others.
CBI Claims under TSCA
In addition, in May 2022 EPA published a proposed rule concerning submitting and supporting confidential business information (CBI) claims under TSCA. The proposed rule, which is expected to be finalized in 2023, attempts to consolidate the TSCA CBI provisions currently found in other TSCA regulations and EPA’s FOIA regulations into a new Part 703. Substantively, the proposed regulations are generally consistent with the guidance and forms EPA has been using to implement the confidentiality provisions of the 2016 Lautenberg Act amendments to TSCA. In particular, the new rules confirm that CBI claims must be accompanied by substantiation at the time of submission and provide standardized questions that must be answered on items such as the extent and likelihood of competitive harm upon release of the information. Consistent with the standardized approach, the proposed rule contemplates using the electronic Central Data Exchange (CDX) platform to submit nearly all substantiation information and for EPA to use it to communicate to submitters any follow-up questions, determinations, or notices of the pending expiration of CBI claims. If a CBI claim is deemed deficient, it will be communicated through CDX and the submitter will have ten days to correct the deficiency.
TSCA Fee Rule
In November 2022, EPA issued supplemental notice of proposed rulemaking addressing changes to the TSCA fee rule first proposed in January 2021. EPA is required to reassess TSCA implementation fees every three years, with the initial fees having taken effect in 2018. Ultimately this proposed rule will promulgate a significant increase in fees manufacturers, importers, and certain processors are required to pay to fund EPA’s costs to implement TSCA. The EPA’s purpose for supplementing the originally proposed rule is due to revenue shortfalls of about half of what was estimated when EPA first established fees in 2018. The proposed TSCA fee increases are significant and will cover regulated entities required to submit information under Section 4 (test orders/rules), Section 5 notices (pre-manufacturing and exemptions), and Section 6(b) risk evaluations. There proposed rule contemplates some relief for small businesses with reduced fees. Of note, Section 5 Pre-manufacturing Notice (PMN) review fees will jump from $19,020 to $45,000 per chemical. For low-volume exemption (LVE) requests and modifications, the fees will jump from $5,590 to $13,200 per chemical. Lastly, for Section 6 risk evaluations, the EPA is proposing to increase the fee from $2,560,000 to a whopping $5,081,000 for EPA-initiated risk evaluations.
New Procedural Regulations
EPA is planning to propose rules in early 2023 to further streamline new chemical reviews. Due to the Lautenberg amendments to TSCA and increased responsibilities for new chemical reviews, EPA is facing significant challenges in completing reviews within 90 days. EPA intends to propose a rulemaking seeking to revise the new chemicals procedural regulations in 40 CFR part 720 to improve the efficiency of EPA's review process and to align its processes and procedures with the new statutory requirements. The rulemaking will purportedly seek to increase the quality of information initially submitted in new chemicals notices and improve the EPA's processes to reduce unnecessary rework in the risk assessment and the length of time that new chemicals are under review. EPA anticipates this effort will be particularly helpful for Low Volume Exemptions (LVEs), which constitute about 60 percent of TSCA section 5 submissions annually.
Under TSCA Section 8(a)(7), which was added as part of National Defense Authorization Act for fiscal year 2020, EPA was required to promulgate a rule by December 31, 2022, requiring each person that has manufactured any of the per- or polyfluoroalkyl substances (PFAS) since January 1, 2011, to report certain information to EPA. The Agency published a proposed rule on June 28, 2021, that required manufacturers and importers of PFAS in any year since 2011 to report chemical identity, categories of use, volumes manufactured or imported, and other information, without any exclusion for small manufacturers. However, based on initial feedback EPA subsequently convened a Small Business Advocacy Review panel and on November 25, 2022, and released and sought comment on an Initial Regulatory Flexibility Analysis (IRFA), which now estimates that small businesses, primarily consisting of article importers, would incur approximately $864 million to complete the one-time reporting. As result of the revised figures, EPA is considering revisions to the PFAS reporting rule recommended by the panel that would limit its applicability through a number of provisions that are analogous to the current Chemical Data Reporting rule exemptions, including creating a list of subject PFAS, establishing a reporting threshold, setting exemptions for small businesses based on annual sales, and incorporating other exemptions for byproducts, impurities, recyclers, intermediates, and research and development substances. Comments on the IRFA were due by December 27, 2022, meaning that a final rule will likely be promulgated sometime in 2023.
EPA is also developing a significant new use rule (SNUR) under section 5(a)(2) of TSCA for certain uses of Inactive Inventory PFAS. Persons subject to the Inactive Inventory PFAS SNUR would be required to notify the EPA at least 90 days before commencing the manufacture or processing of PFAS for any use that EPA has determined is a significant new use. The required notifications would initiate EPA's evaluation of the intended use within the applicable review period. Manufacturing and processing for the significant new use could not commence until EPA had conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination.
Finally, we described EPA’s proposed revisions to expand the available PCB analytical methods and to amend the PCB cleanup and disposal program requirements in last year’s Forecast. Those revisions are currently planned to be finalized in May 2023 and may lead to some much needed updates to the federal PCB analytical and remediation regulations.