On September 28, 2023, the U.S. Environmental Protection Agency (EPA) released a long-overdue final rule under Section 8(a)(7) of the Toxic Substances Control Act (TSCA) regarding reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS). As discussed below, the final rule is not what many of us expected, nor wanted.
EPA states that the reporting rule is a statutory requirement under the fiscal year (FY) 2020 National Defense Authorization Act (NDAA) that requires all manufacturers (including importers) of PFAS and PFAS-containing articles in any year since 2011 to report information related to chemical identity, uses, volumes made and processed, byproducts, environmental and health effects, worker exposure, and disposal to EPA. EPA notes that the final rule will expand on the definition of PFAS in the proposed rule to include 41 additional PFAS that were identified as being of concern. According to EPA, at least 1,462 PFAS that are known to have been made or used in the United States since 2011 will be subject to the final rule. Data are due to EPA within 18 months of the effective date of the final rule, with an additional six months for reports from small businesses that are solely reporting data on importing PFAS contained in articles. The final rule will be effective 30 days after publication in the Federal Register. EPA has released a pre-publication version of the final rule.
Substances Covered by the Final Rule
Scope of PFAS for the Purpose of the Final Rule
As amended by the FY 2020 NDAA, TSCA Section 8(a)(7) requires EPA to collect information on chemical substances manufactured (including imported) for commercial purposes, including chemical substances present in a mixture, that are “perfluoroalkyl or polyfluoroalkyl substances,” or PFAS. EPA notes that TSCA Section 8(a)(7) does not define or characterize “PFAS.” EPA states that it has determined that any TSCA chemical substance (as that term is defined by TSCA Section 3(2)) that falls within the structural definition at 40 C.F.R. Section 705.3 is subject to reporting under TSCA Section 8(a)(7), if it has been manufactured for commercial purposes in any year since January 1, 2011.
According to the final rule, EPA determined that a structural definition was more appropriate for this rule than a discrete list of specifically identified substances. EPA will define “PFAS” in the final rule using a structural definition. PFAS is defined as including at least one of these three structures:
R-(CF2)-CF(R’)R’’, where both the CF2 and CF moieties are saturated carbons;
R-CF2OCF2-R’, where R and R’ can either be F, O, or saturated carbons; and
CF3C(CF3)R’R’’, where R’ and R’’ can either be F or saturated carbons.
EPA states that manufacturers of substances that do not meet this structural definition are not required to report under the final rule. EPA notes that it will provide a list of substances that meet this definition, gathered from the TSCA Inventory, low volume exemptions (LVE), and the CompTox Chemicals Dashboard; the list will be available in the CompTox Chemicals Dashboard at https://comptox.epa.gov/dashboard. EPA states that a substance that is not on this list but that still falls under the definition of a “chemical substance” under TSCA is subject to the final rule if the substance has been manufactured for a commercial purpose since 2011.
EPA states that it “is also affirming that fluoropolymers which meet this rule’s definition of PFAS are reportable under this rule; this includes higher molecular weight fluoropolymers.” According to the final rule, EPA “does not believe the requested data on fluoropolymers would be considered duplicative or unnecessary: this information is not reported to EPA otherwise, and any manufacturers’ existing information on such fluoropolymers will inform EPA’s understanding of such types of PFAS within U.S. commerce, including their downstream uses and their disposal methods.”
EPA notes that the final rule’s definition “may not be identical to other definitions of PFAS used within EPA and/or by other organizations.” According to EPA, various programs or organizations have distinct needs or purposes apart from the final TSCA Section 8(a)(7) reporting rule, and therefore, “different definitions of the term ‘PFAS’ may be appropriate for other purposes.” EPA states that it determined that the definition of “PFAS” is the most appropriate definition for the TSCA Section 8(a)(7) rule and “acknowledges that there may be other rules or programs who apply different definitions to meet their own needs.”
Definition of “Chemical Substance” under TSCA and PFAS in Mixtures
The final rule is limited to manufacturers (including importers) of PFAS that are considered a “chemical substance.” TSCA Section 3(2) defines “chemical substance” as any organic or inorganic substance of a particular molecular identity, including: (1) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature; and (2) any element or uncombined radical. EPA notes that the final rule will not require reporting on activities that are excluded from the definition of “chemical substance” in TSCA Section 3(2)(B).
EPA states that even though the definition of chemical substance excludes mixtures, PFAS as a chemical substance may be present in a mixture. Therefore, the final rule will require reporting on each chemical substance that is a PFAS, including as a component of a mixture. The final rule will not require reporting on components of a mixture that do not fall under the structural definition of PFAS.
Entities Covered by the Final Rule
Scope of Covered Entities
Anyone who has manufactured (including imported) a PFAS for a commercial purpose in any year since January 1, 2011, will be covered by the final rule. EPA states that “manufacture for a commercial purpose” includes the coincidental manufacture of PFAS as byproducts or impurities. EPA notes that the final rule extends to manufacturers (including importers) only and that importers of PFAS in articles are considered PFAS manufacturers.
Persons who have only processed, distributed in commerce, used, and/or disposed of PFAS will not be required to report under the final rule, unless they also have manufactured PFAS for a commercial purpose. EPA notes that TSCA Section 8(a)(7) refers only to manufacturers and that expanding the rule to processors “would be pursuant to EPA’s separate rulemaking authority at TSCA section 8(a)(1), which the Agency is not pursuing at this time.”
Scope of “Manufacture for Commercial Purposes”
Pursuant to TSCA Section 8(f), the scope of “manufacturing” for the purposes of the final rule is limited to entities manufacturing for a commercial purpose. EPA states that it defines “manufacture for commercial purposes” to align with definitions used in other rules. Specifically, “manufacture for commercial purposes” includes the import, production, or manufacturing of a chemical substance or mixture containing a chemical substance with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer. This includes, but is not limited to, the manufacture of chemical substances or mixtures for commercial distribution, including test marketing, or for use by the manufacturer itself as an intermediate or for product research and development (R&D). “Manufacture for commercial purposes” also includes the coincidental manufacture of byproducts and impurities that are produced during the manufacture, processing, use, or disposal of another chemical substance or mixture. EPA notes that “simply receiving PFAS from domestic suppliers or other domestic sources is not, in itself, considered manufacturing PFAS for commercial purposes.” (Emphasis in original.) Entities that process and/or use PFAS need to report only on PFAS they have manufactured (including imported), if any.
According to EPA, entities that have manufactured PFAS for a commercial purpose include those that have imported PFAS (including in wastes), or those that have coincidentally produced PFAS during the manufacture, processing, use, or disposal of another chemical substance or mixture. EPA noted in its proposed rule that this may include certain waste management companies that imported PFAS in a waste or produced PFAS at their site during the disposal of another chemical substance or mixture. EPA states that because no PFAS was listed as a hazardous waste and subject to notification requirements under the Resource Conservation and Recovery Act (RCRA) or other federal laws during the final rule’s look-back period (i.e., since January 1, 2011), and due to general industry practices, EPA understands that importers of municipal solid waste (MSW) streams for disposal or destruction would not have any records or data that they had imported PFAS or any other information relevant to TSCA Section 8(a)(7). Therefore, EPA “has determined that waste management activities involving importing municipal solid waste streams for the purpose of disposal or destruction are not within [the] scope of this rule’s reporting requirements, per EPA’s obligations under TSCA section 8(a)(5)(C).”
The final rule does not broadly exempt all waste management facilities, however. According to EPA, facilities that have imported waste containing PFAS, other than in MSW streams for destruction or disposal, are likely to have information relevant to the final rule. Other waste management sites may have relevant information regarding PFAS contents in waste they have imported outside of MSW, or for the purpose of recycle or reuse; thus, “EPA is required to apply reporting requirements to such entities who may have relevant information, pursuant to TSCA section 8(a)(5)(C).” EPA states that this would include waste management sites that import PFAS-containing waste (including in MSW) for the purpose of recycling or reuse for PFAS-containing products, as well as waste management sites that import PFAS in wastes that are not MSW streams.
Reporting Standard of the Final Rule
For the purpose of the final rule, the reporting standard is information “known to or reasonably ascertainable by the manufacturer,” which EPA notes is the standard used in other TSCA Section 8 rules. EPA states that “‘[k]nown to or reasonably ascertainable by’ is defined to include ‘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.’” According to EPA, this reporting standard requires reporting entities to evaluate their current level of knowledge of their manufactured products (including imports), as well as evaluate whether there is additional information that a reasonable person, similarly situated, would be expected to know, possess, or control. This standard “carries with it an exercise of due diligence, and the information-gathering activities that may be necessary for manufacturers to achieve this reporting standard may vary from case-to-case.”
This standard requires that submitters conduct a reasonable inquiry within the full scope of their organization (not just the information known to managerial or supervisory employees). This standard may also entail inquiries outside the organization to fill gaps in the submitter’s knowledge. EPA states that examples of types of information that are considered to be in a manufacturer’s possession or control, or that a reasonable person similarly situated might be expected to possess, control, or know include: files maintained by the manufacturer, such as marketing studies, sales reports, or customer surveys; information contained in standard references showing use information or concentrations of chemical substances in mixtures, such as a Safety Data Sheet (SDS) or a supplier notification; and information from the Chemical Abstracts Service (CAS) or from Dun & Bradstreet (D-U-N-S). According to EPA, if particular information cannot be derived or reasonably estimated without conducting further customer surveys, however, “it would not be ‘reasonably ascertainable’ to the submitter.”
EPA notes that in the event that a manufacturer (including importer) does not have actual data (e.g., measurements or monitoring data) to report, the manufacturer (including importer) “should consider whether ‘reasonable estimates’ of such information are ascertainable.” According to EPA, “reasonable estimates” may rely on approaches such as mass balance calculations, emissions factors, or best engineering judgment. EPA states that in general, it believes that industry “possesses a greater knowledge than EPA about its own supply chain and operations related to the chemical substances it manufactures and the downstream uses, even if they do not control their customers’ sites.” If manufacturers do not know nor can reasonably make estimates for certain data elements, except for production volumes, however, they may indicate such information is “Not Known or Reasonably Ascertainable” (NKRA) to them in lieu of the requested estimate or range. EPA advises reporters that “NKRA” designations cannot be claimed as confidential business information (CBI) under TSCA Section 14. Reporting NKRA should happen only when “data are truly not reasonably ascertainable or are unattainable (e.g., when the appropriate recordkeeping period has lapsed and a past record is no longer available).”
EPA states that it has published reporting instructions and a Small Entity Compliance Guide that include information related to this reporting standard and the activities that small entities, including article importers, may take to meet the due diligence requirement. These materials should be available in the online docket once the final rule is published in the Federal Register.
Information That Must Be Reported under the Final Rule
General Reporting Form
The final rule will require that PFAS manufacturers submit information for each PFAS, for each year in which that substance was manufactured since January 1, 2011, to the extent the information is known or reasonably ascertainable. For the purposes of this rule, EPA will require this information to be submitted for each chemical substance that is a PFAS. For mixtures that contain at least one chemical substance that is a PFAS, manufacturers must submit information for each chemical substance in the mixture that is a PFAS. EPA states that, for example, a mixture comprised of PFAS A and PFAS B would result in the submission of two forms containing the information described later in the rule for each PFAS. For chemical substances of unknown or variable compositions, complex reaction products, and biological materials (UVCB), including polymers, a single form may be submitted for that UVCB. EPA “encourages submitters of mixtures and UVCBs that contain PFAS to provide additional information in the optional free text box related to the composition of that mixture or UVCB at the time of manufacture, if known.”
Streamlined Reporting Form Option for Article Importers
The final rule will include a reporting option for article importers to provide data to EPA on a streamlined form, if they do not know or cannot reasonably ascertain information requested on the longer standard form. If an article importer determines they have imported a covered substance in an article, they will have the option to provide information to EPA through the streamlined form. According to EPA, the information requested through this streamlined form will still include chemical identity, processing and use information, and production volume, as well as the option to provide any additional information to EPA that the entity may have (e.g., SDS, disposal information).
Streamlined Reporting Form Option for R&D Substances Manufactured Below Ten kgs
The final rule will also include R&D substances that were manufactured, including imported, for a commercial purpose within the scope of this rule. EPA notes that the scope of “manufacture for commercial purposes” encompasses any importing, production, or other manufacturing activities with the purpose of obtaining an immediate or eventual commercial advantage and includes chemicals “for use by the manufacturer, including use for product research and development.” EPA states that R&D substances that meet the scope of “manufacture for commercial purposes” must be reported under this rule, even if the PFAS itself was not later commercialized. R&D substances that have not been manufactured for commercial purposes (such as for scientific experimentation, research, or analysis conducted by academic, government, or independent not-for-profit research institutions, unless the activity is for eventual commercial purposes) would not be within the scope of the final rule, however.
What Must Be Submitted as “All Existing Information Concerning the Environmental and Health Effects” of a Chemical Substance
Pursuant to TSCA Section 8(a)(2)(E), EPA will require the submission of “all existing information concerning the environmental and health effects” of the chemical substances covered by the final rule. EPA notes that “‘[a]ll existing information concerning environmental and health effects’ is defined as ‘any information of any effect of a chemical substance or mixture on health or the environment or both’ (to be codified at 40 CFR 705.3) and is intended to be interpreted broadly.” According to EPA, the scope of “all existing information concerning environmental and health effects” includes all health and safety studies but is not limited to formal studies. EPA states that “[a]ny information that bears on the effects of a PFAS on human health or the environment would be included, including information on the chemical substance developed or generated prior to the year 2011.” The codified definition of “all existing information concerning environmental and health effects” at 40 C.F.R. Section 705.3 provides non-exhaustive examples, including:
Toxicity information (e.g., long- and short-term tests of mutagenicity, carcinogenicity, teratogenicity; pharmacological effects; acute, subchronic, and chronic effects);
Ecological or other environmental effects on fish, invertebrates, or other animals and plants, such as bioconcentration or bioaccumulation tests;
Human and environmental exposure assessments, including workplace exposure, and the impacts of a chemical substance or mixture on the environment; and
Other data relevant to environmental and health effects, including monitoring data to measure the exposure of humans or the environment or a chemical substance, range-finding studies, preliminary studies, adverse effects reports, and any information, including medical screening or surveillance, such as under the American Conference of Government Industrial Hygienists (ACGIH).
The final rule will require all existing information concerning health and environmental effects in the format of Organization for Economic Cooperation and Development (OECD)-harmonized templates, where such templates exist for the type of data. OECD templates are accessible to the public online at https://oecd.org/ehs/templates/harmonisedtemplates.htm. According to EPA, this can be accomplished “by using the freely available IUCLID6 software by exporting the dossier in the OECD Harmonized Template working context.” EPA states that at this time, it can accept any dossiers generated using any version of IUCLID6.
Potentially Duplicative Reporting and Information That Has Already Been Reported to EPA
To address potentially duplicative reporting, EPA identifies specific types of information that need not be reported if the reporting entity indicates in the reporting tool that they have previously provided such information to EPA and provides information sufficient to allow the Agency to locate that information. EPA states that pursuant to TSCA Section 8(a)(5)(A), it is limiting the requirement for reporting “duplicative” information if a PFAS manufacturer has previously submitted the requested information to EPA for that same PFAS in that same year through chemical data reporting (CDR), the Toxics Release Inventory (TRI), the Greenhouse Gas Reporting Program (GHGRP), or TSCA Sections 8(d) and 8(e), or is also reporting a PFAS byproduct on its own reporting form. According to EPA, only the aforementioned data elements from CDR, TRI, and GHGRP; studies submitted under TSCA Section 8(d) or 8(e); and certain byproduct release information may be exempt from re-reporting under the final rule as potentially duplicative information. In these cases, the manufacturer would be required to indicate to which program (and in which year) that information was submitted (e.g., CDR, in 2016). Additionally, EPA notes that a manufacturer’s previous submission for the same data element under a different reporting rule (e.g., a manufacturer previously reported the production volume to CDR for a particular year) does not necessarily mean that the same quantity or information would be accurate for the final rule’s purposes. Because the final rule does not provide for the same exemptions as these other rules, EPA states that the manufacturer must ensure that all quantities and other requested information for that PFAS are reported under the final rule to the extent such information is known or reasonably ascertainable. If a previous submission for a data element does not account for all covered volumes or activities, then the submitter may not rely on that prior submission to satisfy the reporting requirements of the final rule.
Requirements for Submitting CBI Claims
EPA states that PFAS manufacturers reporting under the final rule may claim certain portions of the reporting form are CBI, consistent with TSCA Section 14, such as specific chemical identities that are not on the public TSCA Inventory, company identifier, and production volumes. EPA notes that only confidentiality claims made through the final rule’s PFAS reporting tool “will be considered properly asserted; any additional TSCA CBI claims made elsewhere will be considered improperly presented and will not be treated as having asserted a CBI claim under TSCA, and the information may be disclosed to the public without further notice.”
Information under the final rule that may not be asserted as CBI includes:
Specific chemical identity if the chemical is on the public (non-confidential) TSCA Inventory or reported as non-confidential in an LVE;
All generic chemical names;
For any PFAS that are on the public (non-confidential) Inventory, the chemical’s CAS Registry Number® (CAS RN®);
For PFAS that are on the confidential TSCA Inventory, the Inventory Accession number cannot be claimed as CBI (but the underlying chemical identity can be claimed as CBI);
The following categories of use information: industrial processing and use type, sector, and functional categories, whether a chemical is in a consumer and/or commercial product, the consumer/commercial product categories and functional categories, and its presence in products for children; or
Any blank or NKRA designation or response.
EPA states that any entity that claims a specific chemical identity as CBI must also submit a generic name pursuant to TSCA Section 14(c)(1)(C). This includes reporting a PFAS by either an Accession number or LVE number (assuming that the specific chemical identity is not on the public TSCA Inventory), or reporting by a CAS name on a PFAS for which the CAS RN, Accession number, and LVE number are not known to be assigned (i.e., the CAS RN and specific identifiers have not been created or generated). EPA notes that entities must ensure that any such generic name is consistent with its Generic Name Guidance and that generic names must be sufficiently detailed to identify the reported chemical as a PFAS. According to the final rule, EPA will reject any generic name reported for a PFAS that does not contain “fluor” in the name as insufficient under TSCA Section 14(c)(1)(C).
Electronic Reporting Requirements
The final rule will require all information to be submitted electronically, similar to the requirements established in 2013 for submitting other information under TSCA. Reporters must use EPA’s Central Data Exchange (CDX), the Agency’s electronic reporting portal, to submit all information under the final rule. EPA states that it is developing a rule-specific reporting tool within the Chemical Information Submission System (CISS) that reporters must use to submit the required information. According to EPA, the tool will be available in CISS prior to the start of the reporting period.
When an Entity That Knows the Specific Chemical Identity Will Not Disclose It to the PFAS Manufacturer (Including Importer)
In response to public comment, EPA states that it will enable joint submissions for PFAS manufacturers (including importers) other than article importers that do not know the CAS RN, Accession number, and/or LVE number and whose suppliers will not disclose the identity to the PFAS reporter. According to EPA, similar to the 2020 CDR cycle, the joint submission tool will allow manufacturers (including importers) to submit all importing, processing, use, and other information to the extent it is known or reasonably ascertainable and to send a request to the appropriate supplier or other entity to create a submission to supply the PFAS identity to EPA through the reporting tool. The joint submission process does not require the supplier or other entity to disclose the specific chemical identity to their customer, thus maintaining confidentiality between the two entities.
EPA notes that the joint submission tool would be relevant when a manufacturer (including importer) cannot provide the CAS name, CAS RN, Accession number, or LVE number of a chemical substance it manufactures, generally because it is unknown to the manufacturer (including importer) and claimed in part or in its entirety as CBI by the supplier of the chemical substance or mixture.
In a joint submission, the primary submitter (i.e., the PFAS manufacturer) may assert CBI claims over some of their supplier information, including the supplier identity and the chemical substance or mixture trade name (or other designation). EPA will not require substantiation of the CBI claims for this information at the time of the primary submitter’s submission. The secondary submitter of the joint submission must register with CDX if they have not previously and provide its company name and location, a technical contact, trade name, chemical identity, function, and, for PFAS in mixtures, the percentage of each PFAS in the mixture represented by the trade name. EPA states that the secondary submitter is responsible for asserting all confidentiality claims for the data elements that it submits directly to EPA and for substantiating those claims not exempt under 40 C.F.R. Section 705.30(a)(2). According to EPA, the secondary submitter may claim the specific chemical identity as CBI by following the provisions in 40 C.F.R. Section 705.30. If the secondary submitter does not assert and substantiate a CBI claim for the identity of the chemical substance in its response to EPA, then the chemical is not entitled to confidential treatment. Except for the percentage composition information, which is generally exempt from substantiation pursuant to TSCA Section 14(c)(2)(D), all other reported data elements are subject to substantiation at the time the information is submitted.
EPA states that similar to the CDR joint submissions, any secondary submitter will be able to request the chemical information from their own suppliers as needed, should the importer’s direct supplier not have the information. EPA notes that there may be instances where a foreign supplier purchases a mixture, under a trade name, from another company (tertiary company) and does not know the chemical components of the mixture. EPA suggests that the foreign supplier can ask the tertiary company manufacturing the trade secret mixture or PFAS within the mixture to provide EPA with the correct chemical identity directly in the reporting tool. In this case, the tertiary company would register with CDX and use the Unique Identifier for Joint Submissions, sent to the tertiary company by the secondary company (i.e., the foreign supplier), to complete the reporting form.
EPA notes that joint submissions are to be used only in cases when the PFAS reporter does not know the CAS name, CAS RN, Accession number, or LVE number for the PFAS, but another entity (e.g., a supplier or other manufacturer) does and will not disclose it to the reporter. EPA states that if a reporter (including importer) or joint reporter (secondary or tertiary submitter) actually knows or can reasonably ascertain the CAS name, CAS RN, Accession number, or LVE number of a PFAS, the reporter (including importer) must provide that information irrespective of others’ confidentiality claims. If the reporter wishes to claim the specific chemical identity as confidential, the chemical substance must not be listed on the public portion of the TSCA Inventory, and the submitter must check the CBI box in the reporting tool and provide the appropriate substantiation. Such a CBI claim relates only to the specific chemical identity as listed on the confidential portion of the Inventory (i.e., CAS name and/or CAS RN) and does not apply to the Accession number and generic name listed on the public portion of the Inventory.
Because article importers are not required to assert or substantiate CBI claims for the chemical identity for the final rule, EPA states that it is not requiring or enabling joint submissions for article importers when they do not know the CAS name, CAS RN, Accession number, or LVE number of the PFAS. EPA notes that in scenarios where a secondary submitter is not known or existent (e.g., a supplier has gone out of business and does not have a successor entity), the primary submitter would indicate in the reporting tool that the secondary submitter is “not known or reasonably ascertainable.” In this case, the PFAS manufacturer would be required to provide as much identifying detail as they have regarding the PFAS identity (e.g., trade name), but would be able to report to EPA without initiating a joint submission.
Due Dates for Reports
In response to public comment, EPA states that the final rule will provide a one-year information collection period following the final rule’s effective date that will then be followed by a six-month reporting period. EPA will grant an additional six months for reporting to small manufacturers (as defined at 40 C.F.R. Section 704.3) whose reporting obligations under the final rule are exclusively from article import. EPA states that “small manufacturers,” as defined at 40 C.F.R. Section 704.3, include manufacturers that meet one of two standards: (1) a manufacturer (including importer) whose total annual sales, when combined with those of its parent company, are less than $120 million, and the annual production volume of a chemical substance is less than 100,000 pounds; or (2) a manufacturer (including importer) whose total annual sales, when combined with those of its parent company, are less than $12 million. EPA “acknowledges that the scope of reporting for this rule is broader than for CDR, and that there may be some reporting entities who have not submitted information to EPA under a TSCA section 8(a) reporting rule before (e.g., some small manufacturers).” Therefore, EPA agrees that additional time is warranted for PFAS manufacturers to familiarize themselves with the scope of the reporting rule and reporting standard, as well as to begin to collect the required information and create a CDX account if necessary. Reporting forms will be due 18 months following the effective date of the final rule, except for small article importers (as defined at 40 C.F.R. Section 704.3), whose reporting forms are due 24 months following the effective date of the final rule.
Each person who is subject to the reporting requirements must retain records that document any information reported to EPA for five years, beginning on the last date of the information submission period. EPA notes that the five-year retention requirement “is consistent with the CDR rule and corresponds with the statute of limitations for violations and is necessary to preserve records to support future regulatory activities that will be informed by this information collection.”
We have decidedly mixed views on EPA’s final rule. The final rule is largely unchanged from the proposed rule, despite the many comments about the undue burden that potential reporters will face to determine if they have any information to report. EPA appears to be indifferent to the due diligence burden, focusing almost entirely on the reporting burden. In the end, we expect that EPA will receive tens if not hundreds of thousands of reports that the information sought by EPA is NKRA and reporters will have spent millions of dollars in an effort to fill EPA’s databases with nearly useless information.
Unfortunately for potential reporters, the reporting period just keeps getting longer. Because of the statutory language, EPA cannot move the beginning of the look-back period (January 1, 2011) but delays before the reporting period begins extend the look-back period. The generous time that EPA is allowing for data gathering will increase the reporting burden — perhaps an unavoidable result.
We agree with EPA’s decision to not provide a specific list of PFAS with CAS RNs; rather, a structural definition may allow EPA to gather critical information about substances that are known to be manufactured (such as byproducts) that would be exempt from other obligations. We are relieved that EPA did not broaden the definition of PFAS to include substances with a single fluorinated carbon (trifluoromethyl groups). We agree with EPA that this larger universe of substances will not help EPA with the concerns it is attempting to address. On the other hand, we are surprised that EPA eliminated the limitation on its structural definition wherein substances that had hydrogens adjacent to the carbons with fluorines were not considered PFAS and we found EPA’s justification for this change lacking rigor, especially when EPA is aware that adjacent hydrogens allow for degradation via dehydrohalogenation, thereby significantly reducing the persistence concern.
We are disappointed that EPA seemingly disregarded the significant concerns identified by potential reporters in the final rule. Since the inception of this rule, EPA has significantly underestimated the effort required to complete the due diligence given that the only exemption is for the import of MSW. All other importers, regardless of size, must examine every product, including articles, imported since 2011 to determine if the reporter knew or if the reporter can reasonably ascertain whether there was a PFAS present in the product at any level, what PFAS is or may be present, in what quantity, and for what purpose, and, in most cases, what happens to that PFAS during processing and use.
EPA dismisses these concerns by stating that reporters only must report what is “known or reasonably ascertainable.” Our expectation is that the reporting will be a minor component of the effort required to comply with this rule. So now every automaker, electronics company, wholesaler, retailer, even every Esty shop will have to search for more than 12 years of purchase records, if available, to determine what was imported and if a PFAS was or might have been present. The only exemptions EPA provided is non-commercial R&D (e.g., strictly academic research) and importers of MSW. EPA neglected even to provide an exemption for PFAS substances that result “from a chemical reaction that occurs incidental to exposure of another chemical substance, mixture, or article to environmental factors such as air, moisture, microbial organisms, or sunlight” (the exemption at 40 C.F.R. Section 720.30(h)(3)). Such degradation is manufacturing according to EPA’s definition, so if a company is using (not importing) an article with a PFAS coating and the company observes that over many years, the PFAS coating degrades and must be replaced, that company must determine if it knows what the degradant is (probably not), how much is formed (which would at best be a guess), and report to EPA that an unknown PFAS is formed over an unknown amount of time in an unknown quantity. It is difficult to understand how that information would be useful to EPA. Information that will require extensive effort by thousands — perhaps hundreds of thousands — of reporters that will contribute little to EPA’s understanding of the potential risks of PFAS. Perhaps this circumstance is not what EPA intended to include in its definition of manufacturing, but if so, EPA could have explicitly included this, and similar, existing exemptions under 40 C.F.R. Section 720.30(h) in the reporting rule. By excluding these exemptions, one could reasonably conclude that EPA specifically intends for these circumstances to be reportable.
While we understand that EPA had good cause to think that some entities would have information related to import of articles that are known to contain PFAS and there certainly are circumstances in which EPA had legitimate concerns about byproduct PFAS and PFAS as impurities, EPA could have limited the reporting obligations. For example, EPA could have only required reporting for articles with intentionally added PFAS. EPA also could have set a de minimis level of PFAS as an impurity, such as the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) limit of 25 ppb for the presence of perfluorooctanoic acid (PFOA). EPA could have exempted very small businesses. EPA did none of these things, despite the many comments EPA received seeking a more temperate approach to this reporting obligation. EPA’s dismissive tone is summed up with its statement that “many reporters under this rule are familiar with this reporting standard, and resources are available to support those reporters who may not be familiar with the standard.” The majority of potential reporters — those that were exempt from other reporting rules because of the various exemptions — will probably have little familiarity with “Chemical Data Reporting,” much less be familiar with the rule or reporting standard. Despite EPA’s contention, we are unaware of resources available to support those reporters, and consultant resources are not free and provide inadequate bandwidth to accommodate a reporting burden of this magnitude. A one-hour webinar and EPA guidance document in EPA’s traditional CDR parlance is not going to help a furniture importer or Esty shop understand its reporting obligations under TSCA, and for EPA to think otherwise is optimistic at best. It is not clear what EPA expects from such entities or if EPA will seek to enforce the PFAS reporting rule from such entities. If EPA thinks such entities need not worry about reporting under this rule (or the potential enforcement reprisals for non-reporting), EPA should have exempted them from the requirement rather than hand-waving the concern away.
EPA’s guidance on the due diligence standard is not yet available. If EPA does not address the myriad scenarios in which a potential reporter suspects that a PFAS may be present (e.g., in an electronic device with a semiconductor chip that may have been manufactured using a PFAS) but cannot confirm or refute the presence of a PFAS, what is EPA’s expectation? EPA states that such a reporter “may not have knowledge that they have manufactured or imported PFAS and thus need not report under this rule.” An electronic device was likely made with and may have residual PFAS embedded deep within, is that sufficient to trigger reporting? Or is the fact that the importer of that device does not know sufficient to not report? An imported sofa might have been treated with a stain resistant PFAS coating, is the fact that the sofa might have been treated sufficient to trigger reporting?
We urge potential reporters to ask EPA specific questions about their unique scenarios to elicit EPA’s specific view on the level of knowledge EPA expects to trigger reporting when a reporter knows (or suspects) that a PFAS is present but has no other information to report. Does EPA really want hundreds of thousands of reports that contain “NKRA” across the board? Our read of this rule is, yes, that is exactly what EPA is requiring. EPA states that “[r]egarding manufacturers who have concerns over the due diligence expected under this rule, including those who believe they ultimately will not obtain any reportable information, EPA clarifies that there is no reporting or recordkeeping requirement if an entity has no relevant information. This rule does not itself require any company to maintain information upon which a decision not to report is based.” Here, EPA states that recordkeeping for non-reporting is not required, but how then will EPA know that a potential reporter performed the due diligence that is required? Elsewhere, EPA states “EPA encourages such an entity to document its activities to provide evidence of due diligence.” Which is it, that non-reporters must document evidence of due diligence, or such records are not required?
We are also disappointed that EPA assumes that all potential reporters are familiar with IUCLID. EPA’s assumption is not supported by our experience. Few of our U.S.-only clients are familiar with reporting in IUCLID because they do not operate in Europe. U.S. clients without a European Union (EU) presence generally use an Only Representative (OR) for REACH registrations, so the companies are unfamiliar with IUCLID; instead, they rely on the OR for that expertise. EPA management is probably not aware, but IUCLID has a very steep learning curve. New IUCLID users will struggle to learn to report properly. EPA seems indifferent to this fact. We also question the value of the IUCLID-templated study summaries. In our experience, EPA frequently ignores submitter interpretations of study results in preference for its own interpretations, so EPA would rewrite those study summaries, negating the value of the submitter’s templated submission.
While we understand EPA’s need for information about PFAS, EPA has ignored pleas to reduce the burden on entities that are unlikely to have the useful information EPA seeks. Instead, EPA is expecting a tremendous amount of effort from a broad swath of the economy to elicit information that will not vary significantly from what EPA would have received if it had been discerning about the actual burden of the rule, rather than focusing exclusively on the reporting burden. It remains to be seen if any regulated entities will challenge this final rule.