In 2021, our blog post alerted readers to a concerning expansive June 2021 TSCA proposed reporting requirement that could apply to a range of manufacturers or importers of products containing PFAS, potentially scooping up everyone from manufacturers or importers of such products as water-repellant t-shirts, nonstick cooking ware and high performance mountain gear and more. The Proposed Rule would require manufacturers and importers to provide ten years of past data and details regarding Per- and Polyfluoroalkyl Substances (PFAS) in the product, regardless of the quantity of the PFAS and regardless of the size of your company. This new Part 705 to the Toxic Substances Control Act (TSCA) regulation seeks to impose a one-time reporting requirement on all manufacturers and importers of PFAS or finished products containing PFAS to provide a wide variety of information regarding the PFAS dating back to January 1, 2011. The comment period ended on September 27, 2021 and the Proposed Rule must be finalized by January 1, 2023.
As we noted in our previous Blog posting, the Proposed Rule is unprecedented in its scope:
- Proposed rule applies to all manufacturers and importers of PFAS, including manufacturers and importers of articles (i.e., finished products) containing PFAS.
- The Proposed Rule does not contain any of the standard exemptions found under other TSCA reporting rules. There is no exclusion for articles containing chemical substances. There is no exemption for small businesses. There is no minimum quantity threshold. There is no exemption for byproducts. There is no exemption for impurities. There is no research and development exemption. .
- Practically all PFAS are included. The Proposed Rule includes five extensive lists of PFAS, but it states that the lists are not comprehensive and the list may grow. Further, EPA explains that the lists serve to provide “examples” of the categories of PFAS covered by the Proposed Rule, not a limitation on the covered PFAS.
- The Proposed Rule would require information “known to or reasonably ascertainable by” the manufacturer or importer.
- Inexplicably, EPA certified that the Proposed Rule did not have significant impacts on a substantial number of small entities under the Regulatory Flexibility Act.
- We predicted that, once EPA better understood the impacts of the Proposed Rule, EPA could decide to reduce the scope of the Proposed Rule to allow some exemptions and create a threshold quantity for PFAS.
Consistent with our observations and predictions, it appears that EPA may be reconsidering some of the scope and economic impacts of the Proposed Rule based on comments received in response to the Proposed Rule, particularly regarding economic impacts on small entities. Significantly, many commentors questioned whether EPA had sufficient data of burden and cost to support its certification regarding the impact on small business entities. The Small Business Administration Office of Advocacy found that it would be difficult or impossible for small business to comply with the Proposed Rule.
In response to these comments, pressure from the Industry and the SBA, EPA convened a Small Business Advocacy Review (SBAR) Panel on April 20, 2022 to review the Proposed Rule and obtained advice and recommendations of representatives of small businesses likely to be impacted by the Proposed Rule. An Initial Regulatory Flexibility Analysis (IFRA) Report and an Updated Economic Analysis was issued for public comment on November 25, 2022. EPA requested comment on the IFRA by December 27, 2022. EPA faces a statutory deadline to finalize the PFAS reporting rule by December 31, 2022. The IFRA recognizes many of the limitations and difficulties presented by EPA’s original approach under the Proposed Rule.
- Implementation of the Proposed Rule is very expensive.
EPA has updated its estimate of costs for the Proposed Rule from approximately $10.8M to $875M. The costs for small businesses went from “no significant impacts” to $863,483,965 in costs for the one-time reporting.
- Maybe EPA has seen the light that regulatory flexibility is needed.
As stated above, EPA did not consider any of the regulatory flexibilities and exemptions found under other TSCA programs. The IFRA requests comments on the following:
o Potential reporting thresholds of 2500 lbs. or 25,000 lbs. manufactured or imported per year.
o Exemptions for businesses based on revenue with less than $12 million or $6 million in revenue.
o Limiting the scope of PFAS to a finite list.
o Establishing reporting thresholds.
o Simplified reporting forms for certain entities such as article importers or manufacturers of small quantities of research and development substances.
o Reporting exemptions found in other TSCA programs such as for research and development substances, byproducts, impurities, recyclers, and intermediates.
o De minimis or research and development exemptions.
o Potentially duplicative or overlapping reporting requirements.
- EPA takes the opportunity to highlight purported “benefits” of the Proposed Rule.
There is a significant concern that the data to be generated under the Proposed Rule lack practical utility and the unclear ends do not justify the very expensive means. EPA responds to this criticism by touting “benefits” of the data to be generated under the Proposed Rule. However, the recitation of “benefits” appears to be the result of EPA’s brain-storming exercise of any possible use of the data – the fundamental equivalent of throwing spaghetti at the wall to see if it will stick. Some of these “benefits” include:
o Understanding the types of manufacturing processes and reactions that can form or transform PFAS may provide useful insights for characterizing exposure and risk for PFAS.
o Understanding the uses and universe of PFAS in a current and historical context is needed to fully characterize exposure and risk associated with PFAS.
o Increased data on the production and use of PFAS would allow EPA and other federal agencies to use the data more effectively as part of screening and prioritization programs.
o The Office of Land and Emergency Management may use the data to understand the level of contamination and current risks posed by PFAS and to guide future RCRA and CERCLA actions.
o The Office of Air and Radiation could use the collected data to potentially identify sources of PFAS air emissions and increase understanding of the hazards associated with certain PFAS.
o The Office of Water could use the data to inform decision making on various actions such as listing of contaminants under the Contaminant Candidate List under the Safe Drinking Water Act.
- The IFRA report attempts to soften some of the difficulties presented by the Proposed Rule.
As stated above, the Proposed Rule would require reporting of information “known to or reasonably ascertainable by” the manufacturer or importer. The Proposed Rule explains that this means “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control or know.” Many entities raised concerns regarding the scope and practicality of this “reasonably ascertainable” standard, with concerns especially amplified for small entity importers of articles. EPA attempted to assuage some of these concerns:
- In recognition that many submitters will not have records going back to January 1, 2011, EPA indicates that the submitter is just required to document why records do not exist for the full reporting period.
- An inquiry within the “full scope of an organization” and an “inquiry beyond managerial and supervisory employees,” as referenced in the Proposed Rule, does not require an exhaustive survey of all employees or former employees, but rather such inquiry should include research and development and sales employees.
- EPA states that extensive supply chain surveys are not required. Rather, inquiries outside the organization may be fulfilled by contacting first tier/immediate suppliers, major suppliers and examining a supplier’s public website.
- Testing is not required under the reasonably ascertainable standard.
- What comes next?
The public comment period for the IFRA ends on December 27, 2022, leaving EPA little room to address the comments and finalize the rule by the statutorily mandated December 31, 2022 deadline. As stated in our previous Blog, this reporting requirement was not part of the 2016 TSCA amendments, but rather it is a standalone provision in omnibus defense legislation that limits EPA’s discretionary authority regarding the scope and timing of the reporting requirements, including the firm deadline of January 1, 2023 for the final rule to be issued. It is clear that EPA needs more time but unclear regarding how they will go about it.
A closing thought – What to do when the dog catches the car?
Even with the deep dive taken in the IFRA, it is still unlikely that EPA really understands what it is asking for. The huge field of potential reporters and requested data will likely result in a cumbersome and unwieldy set of information that will be difficult to manipulate to understand true PFAS risks. It is anticipated that EPA will need to wade through a sea of non-responsive data (e.g., importers that have limited data on the articles resulting in potentially thousands of “not known or reasonably ascertainable” responses) to assemble a usable subset of information. Allowing some of the exemptions found under other TSCA programs, as well as refining the list of PFAS subject to the reporting requirement, could result in a more usable set of information to support the “benefits” espoused by EPA.
Postscript – another tightening of the PFAS belt?
As noted above, the IFRA requests comment on whether there should be a de minimis exemption from the Proposed Rule’s reporting requirements, similar to what is found under the TSCA export notification requirements. Although not directly applicable, it should be noted that on December 5, 2022, EPA proposed to add PFAS chemicals subject to the Emergency Planning and Community Right to Know Act’s Toxic Release Inventory (TRI) reporting to the list of Lower Thresholds for chemical of Special Concern and, more importantly, would eliminate the use of the de minimis exemption under the Supplier Notification Requirements for facilities that manufacture or process all chemicals included on the Chemicals of Special Concern list. This potential development was referenced in the IFRA thus indicating some relevance (and maybe EPA’s reluctance) to the Proposed Rule’s suggestion for a de minimis exemption to the reporting requirements.
 The PFAS Act of 2019, which was part of the omnibus National Defense Authorization Act for Fiscal Year 2020, added section 8(a)(7) to TSCA providing: PFAS Data. Not later than January 1, 2023, the Administrator shall promulgate a rule in accordance with this subsection requiring each person who has manufactured a chemical substance that is a perfluoroalkyl or polyfluoroalkyl substance in any year since January 1, 2011, to submit to the Administrator a report that includes, for each year since January 1, 2011, the information described in subparagraphs (A) through (G) of paragraph (2).
 The only manufacturers and importers of articles that are excluded are those manufactured and imported products and articles for food, medical and cosmetic uses that are regulated by other federal statutes.
 Food, drugs and cosmetics regulated by the Food and Drug Administration are excluded from TSCA’s reporting coverage.
 Significantly, the Proposed Rule certified that it would not have significant impacts on small entities.
 Similar to the Proposed Rule, the changes to TRI reporting for PFAS also has its genesis in the part of the omnibus National Defense Authorization Act for Fiscal Year 2020.
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