Complying with the "Known or Reasonably Ascertainable" Standard for PFAS reporting
TSCA Section 8(a)(7) imposes a significant reporting burden on manufacturers and importers. The standard of "known or reasonably ascertainable" is crucial to the compliance process. This standard implies a duty to conduct a thorough investigation to gather all relevant data. Here’s how manufacturers can approach this challenge:
The first stage to meeting this standard requires data gathering on a comprehensive and granular level. This starts with an in-depth review of all internal records and relevant documents including product formulations, manufacturing processes, supplier information, safety data sheets (SDS), and other materials that may indicate your use of PFAS (e.g. product designs). Suppliers must be contacted to obtain information about PFAS content in raw materials and components. Furthermore, manufacturers and importers must analyze existing research data, including previous test results and analytical reports.
TSCA Section 8(a)(7) and related EPA publications provide guidance on how organizations may choose toapproach these tasks. The “Reasonably Ascertainable” standard means you must clearly outline the scope of your investigation, considering the nature of your business and the available resources. You must also document all these efforts by maintaining detailed records of data collection and analysis to demonstrate due diligence. It may be necessary to seek expert advice by engaging consultants or legal counsel to navigate complex issues.
Not everything in the supply chain can be reasonably known or ascertainable. If precise data is unavailable, consider using reasonable estimates or approximations based on available information. Manufacturers can also use industry accepted methodologies for data estimation. But remember that transparency is necessary. Whatever the exact approach, your organization must clearly document your due diligence - including the basis for any estimates or approximations. Note that this EPA ruling requires relevant records be retained for a period of 5 years.
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This processshould not be considereda one-off eventas other markets require, or are considering requiring, PFAS-related reporting.?Canada, for example, announced on July 27, 2024[1]a mandatory survey to obtain information on the manufacture, import, and use of 312 specific per- and polyfluoroalkyl substances (PFAS). It is vital to consider impementingprocesses to effectively monitor the use of PFAS in your organization.Thisincludesthe implementation of technology to track PFAS-related information and facilitate future reporting. This will help you to establish strong and lasting relationships with your suppliers to ensure ongoing data availablity. If you are not in a position to maintain staff to monitor regulatory updates and industry best practices use external experts.
By following these guidelines and demonstrating a proactive approach to data collection and analysis, manufacturers can increase their chances of complying with the "known or reasonably ascertainable" standard and mitigating potential risks associated with TSCA Section 8(a)(7).