Chemical Manufacturers, Processors, and Importers (Including Importers of Articles) Must Provide Feedback on Substantial Changes to EPA’s TSCA Reporting Requirements
The Environmental Protection Agency (EPA or Agency) recently hosted a webinar to introduce the Agency’s intent to propose a groundbreaking new reporting and recordkeeping rule pursuant to Toxic Substances Control Act (TSCA) Sections 8(a), (c), and (d). If you manufacture, process, import, or distribute—or even propose to manufacture (including import), process, or distribute—chemical substances or mixtures, including articles and byproducts, you should closely follow this upcoming rulemaking and provide EPA comments on the general framework described in the Agency’s webinar presentation by August 16, 2021.
This unexpected addition to the existing chemical review framework will likely introduce a sea change in TSCA reporting and recordkeeping requirements that could impose significant annual burdens on manufacturers, processers, and distributors, including small entities and importers of articles. If the Agency’s proposed PFAS reporting rule is any indication of how EPA intends to use its TSCA Section 8 authorities, the reporting requirements may be extensive.
What Will Be Required
EPA refers to the future new rule as the Tiered Data Reporting Rule (TDR Rule). As described by EPA, data will be required for three distinct phases of the agency’s process for reviewing existing chemicals:
- Conditions of Use Data (COU). At the outset, reporting would be required for chemicals that the Agency might consider for prioritization—a “pre-prioritization” step not required by TSCA. EPA would use the data that it collects to determine whether the chemical should (a) enter prioritization or (b) “return” to the general pool of chemicals authorized under TSCA. During last month’s webinar, EPA indicated that the reporting requirements would commence when the Agency “lists” the chemical as a candidate for prioritization under the TSCA risk evaluation framework (only those chemicals that EPA determines as “high priority” ultimately undergo TSCA risk evaluations). Impacted companies would need to submit the required information to EPA only three months after the “listing” and annually thereafter.
- Prioritization Data Set. This second set of data would apply to chemicals formally included in the TSCA prioritization step and would help EPA determine which chemicals should be considered a “high priority” and therefore undergo a risk evaluation. Companies again would be required to submit information to EPA only three months after initiation of prioritization and annually thereafter. The 2016 changes to TSCA place guideposts on EPA when it seeks data at this point in the process that EPA will need to follow.
- Risk Evaluation/Risk Management Data Set. This final set of data would provide information for EPA’s risk evaluation and risk management activities, apply when the chemical is formally categorized through the TSCA process as a high-priority chemical, and be due 4-6 months after the commencement of the risk evaluation (again, with annual reporting requirements).
During any and all of these steps, companies may need to submit the following information and data to EPA: industrial, commercial, or consumer uses; product and article information; discontinued or phased-out uses; health and safety information, such as toxicity information, exposure monitoring information, worker exposures, and engineering controls to reduce exposure; physical-chemical properties; federal and state regulatory actions; and information on substitute chemicals that are safe and effective alternatives.
Manufacturers (including importers) would be required to submit data for the COU and prioritization data sets. The risk evaluation/risk management reporting requirements would apply to both manufacturers (including importers), processors, and distributors.
What to Watch For
Of particular note, EPA’s new TDR concept signals the re-introduction of a “pre-prioritization” step in the TSCA Section 6 review process. EPA proposed and subsequently dropped pre-prioritization in the Final Prioritization Rule due to “widely differing, and often irreconcilable views by commenters.” It appears that pre-prioritization is back—and merits significant stakeholder engagement. Finding your chemical or use on the pre-prioritization or “candidate” list could have unintended consequences for your company—without the ability to provide EPA with information on why such a listing lacks merit.
Companies will also want to provide feedback on EPA’s plan to use its TSCA Section 8(c) authority as part of the TDR Rule. This provision and its implementing regulations require manufacturers (including importers), processors, and distributors to maintain records on and, upon request, provide to the Agency the following type of information:
- Significant adverse health effects;
- Consumer allegations;
- Occupational disease or injury; and
- Complaints of injury to the environment.
Potentially impacted stakeholders should engage with EPA now and share their experiences with complying with the current Section 8(c) recordkeeping obligations.
According to EPA’s Federal Register notice, stakeholders must submit written comments on this prospective rulemaking by August 15, 2021. Given that this date falls on a Sunday, however, comments are due on Monday, August 16, 2021 (which is consistent with the date indicated in EPA’s webinar slides).
EPA has not stated when it plans to issue the actual proposed TDR Rule. In these situations, based on our experience, it is important to engage EPA early in the rule development process and especially in response to an invitation for public comments. Oftentimes, EPA will stick to its proposed framework in cases like this when the Agency seeks time-sensitive information to inform current and future mandated activities. Therefore, it is especially important to scrutinize carefully this early framework now and provide EPA with constructive feedback for shaping both the proposed and the final TDR Rule.
If you have questions on the potential applicability of this rule to your company or need assistance with drafting comments in response to this proposed framework, Wiley can help. Please contact us for more information.