The Environmental Protection Agency (EPA) recently hosted a webinar to present the Agency’s intention to propose a revolutionary new reporting and record-keeping rule in accordance with Sections 8 (a), (c) and ( d) of the Toxic Substances Control Act (TSCA). . If you manufacture, process, import or distribute, or even to propose to manufacture (including import), process or distribute chemicals or mixtures, including articles and by-products, you must closely follow these future regulations and provide feedback to the EPA on the general framework outlined in the presentation of the Agency’s webinar by August 16, 2021.
This unexpected addition to the existing chemicals review framework is likely to result in a drastic change in TSCA’s reporting and record keeping requirements that could impose significant annual burdens on manufacturers, processors and distributors, including small entities and importers of articles. If the PFAS reporting rule proposed by the Agency is any indication of how the EPA intends to use its TSCA Section 8 powers, the reporting requirements may be extended.
What will be required
The EPA refers to the future new rule as the multilevel data reporting rule (TDR rule). As described by the EPA, data will be needed for three distinct phases of the agency’s process for reviewing existing chemicals:
- Prioritization dataset. This second set of data would apply to chemicals officially included in the TSCA prioritization step and help the EPA determine which chemicals should be considered a âhigh priorityâ and therefore undergo a risk assessment. Companies would again be required to submit information to the EPA only three months after prioritization begins and annually thereafter. The 2016 changes to the TSCA put beacons on the EPA when it searches for data at this point in the process that the EPA will need to go through.
- Risk assessment / risk management dataset. This final dataset would provide information for the EPA’s risk assessment and management activities, apply when the chemical is formally classified by the TSCA process as a high priority chemical, and be due 4-6 months after the start of the risk assessment (again with annual reporting requirements).
During all of these stages, companies may need to submit the following information and data to the EPA: industrial, commercial, or consumer uses; product and article information; uses abandoned or phased out; health and safety information, such as toxicity information, exposure monitoring information, worker exposure and engineering controls to reduce exposure; physico-chemical properties; federal and state regulatory actions; and information on alternative chemicals that are safe and effective alternatives.
Manufacturers (including importers) would be required to submit data for the EOC and prioritization data sets. Risk assessment / risk management reporting requirements would apply to both manufacturers (including importers), processors and distributors.
What to watch
In particular, it should be noted that the EPA’s new RDT concept signals the reintroduction of a âpre-prioritizationâ step into the TSCA Section 6 review process. The EPA proposed and then dropped pre-prioritization in the final prioritization rule due to “very different and often irreconcilable views on the part of commentators.” It seems that pre-prioritization is back and deserves significant stakeholder engagement. Finding your chemical or its use on the pre-prioritization or âcandidateâ list could have unintended consequences for your business, without the ability to provide the EPA with information on why such a list lacks merit. .
Companies will also want to comment 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 keep records and, upon request, provide the Agency with the following type of information:
- Significant adverse health effects;
- Consumer claims;
- Occupational illness or injury; and
- Complaints for damage to the environment.
Potentially impacted stakeholders should engage with the EPA now and share their experiences of complying with current section 8 (c) record keeping obligations.
According to the EPA’s Federal Register notice, stakeholders are to submit written comments on this future regulation by August 15, 2021. Since this date falls on a Sunday, however, comments are due on Monday the 16th. August 2021 (which is the date shown in the EPA webinar slides).
The EPA has not indicated when it plans to release the actual proposed TDR rule. In these situations, based on our experience, it is important to involve the EPA early on in the rulemaking process and especially in response to an invitation for public comment. Often times, EPA will stick to its proposed framework in cases like this, when the Agency seeks urgent information to inform current and future mandated activities. Therefore, it is particularly important to carefully consider this first frame. now and provide constructive input to the EPA for the development of the proposed and final TDR rule.