If you’ve been a manufacturer (including an importer) of Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) since January 1, 2011, keep reading – you’ll want to pay close attention to a new call for data from the Environmental Protection Agency (EPA) .
Using Section 8 (a) of the Toxic Substance Control Act (TSCA), as amended by the National Defense Authorization Act (NDAA) of 2020, the EPA proposes an important single reporting requirement for all manufacturers of PFAS.
Should we care? Probably yes. As proposed, this rule will affect a extensive number of entities by applying regulatory TSCA reporting requirements over a ten-year horizon to more than 1,000 PFAS compounds. This group includes businesses that import items and small entities, unless the EPA is persuaded to add exemptions or allowances for these and other groups during the rulemaking process. The proposed reporting requirement also applies to all PFAS level, even if it is an impurity in your products.
Industries that will need to take a close look at their products and items include those engaged in the manufacture, import and distribution of the following: chemicals, unlaminated plastic films / sheets, abrasives, electronics, containers, automobiles, navigation equipment , medical equipment and surfaces and performance coatings for industrial and consumer products. Examples of potentially affected consumer products companies include importers and manufacturers of sports and leisure equipment, water-resistant clothing, and rugs. Additionally, waste management and disposal companies will want to understand how this potential rule can apply to them.
Scope and timing.
At least 1,364 chemicals and PFAS mixtures are reported if they have been manufactured in a year since January 1, 2011. The EPA’s proposal applies broadly to articles (including including articles containing PFAS as part of a surface coating), mixtures, by-products, and impurities containing all amount of PFAS substance. The changes made to the TSCA by NDAA 2020 prevented the EPA from granting an exemption to this rule for small entities. Therefore, small entities, even those importing items, are included in the extended reporting requirements.
The rule collects a wide range of information related to the identification and structure of chemicals, production, use, exposure, disposal and effects on health and the environment. . In the event that the manufacturer does not have actual data to report to the EPA (for example, surveillance data), the EPA proposes to require the manufacturer to make “reasonable estimates” of this information. .
The following are examples of information required for submission:
- Chemical name, molecular structure, physical form, function and use.
- Consumer and commercial uses, maximum concentrations used in any product and information on use in products intended for children.
- Information on worker exposure, including the maximum exposure for any job for each worker activity.
- Descriptions of elimination processes.
- All existing information on the environmental and health effects of the substance or mixture, not limited to studies conducted or published since 2011.
The type of data the EPA proposes to collect may signal the Agency’s intention to use worst-case scenarios to predict the risk of exposure to PFAS. The proposed report relates to “maximums” (eg, the maximum exposure time for any worker) and other data, such as averages or estimates of central tendency, are not sought.
It should also be noted that meeting the reporting requirements of this proposal can be particularly difficult for small entities that are not used to maintaining these types of records. While the EPA must include small entities to comply with the NDAA, smaller entities may want to consider whether there are less onerous regulatory reporting options that could be finalized. These requirements are included without a full understanding of the economic impact that the proposed rule will have on small entities. The EPA’s proposal notes that they lacked information on the number of small importers of items subject to the rule. Any final rule could benefit from information that helps the EPA determine the true economic impact on small entities.
The EPA is required by the NDAA 2020 to promulgate the rule no later than January 2023. The EPA’s Spring Regulatory Program indicates the agency’s intention to finalize the rule by July 2022.
The EPA is proposing a six-month reporting period that would begin six months after the effective date of the final rule. If the EPA finalizes the rule in July 2022 as planned, reporting requirements would likely begin in early 2023.
How to comment.
On August 3, 2021, the EPA issued a notice announcing an extension of the public comment period from August 27, 2021, until September 27, 2021.
Any company that thinks they are included in this report should intervene during this comment period and, where appropriate, request exemptions. If the comments are not included in the dossier for the proposed rule, the EPA’s final rule may have an unexpected impact on businesses. While the EPA has not used any action insurance when companies have been taken by surprise by their past regulations, it is not a mechanism every business should rely on. Companies might not be able to request relief from the EPA due to the opportunity to comment on this proposal.
If you have questions about the rule’s applicability to your company’s products, Wiley can help. Please contact us for more information.