A new rule enacted by the U.S. Environmental Protection Agency (EPA) now obligates any company that makes or imports PFAS to comply with new — and strict — reporting and recordkeeping requirements.
The creation of this rule was mandated by law in 2020 under an amendment to the Toxic Substances Control Act (TSCA).
According to the EPA, the rule's purpose is two-part:
- Develop a comprehensive database that will improve the EPA's ability to understand and monitor the scope of PFAS's prevalence — past, present, and future — in U.S. commerce and the environment
- Use that data base to further guide and support actions to assess and mitigate PFAS contamination, exposure, and risks.
In this Q&A, we'll cover when the rule takes effect, who it applies to, how it defines PFAS, what it requires, its deadline to comply, the penalties for non-compliance, and how Actalent is positioned to help companies comply without disrupting or adding strain to their core business activities.
Q: When does this new rule take effect?
A: The new rule, authorized under section 8(a)(7) of TSCA, takes effect November 13, 2023.
Q: Who does the EPA's new rule apply to?
A: It applies to any person or entity that manufactures or imports PFAS for a commercial purpose in the U.S. or has at any time since January 1, 2011.
Q: What does the new rule require?
A: It requires all PFAS manufacturers and importers to provide reports on PFAS uses, production volumes, disposal, exposures, and hazards for every year dating back to January 1, 2011 and, in some cases, provide records that date back even further (this is discussed further under the question: What kinds of information must be reported?)
Q: What are the risks and penalties of non-compliance?
A: Failure to comply could result in fines of up to $50,000 per day, per violation, as well as potential criminal penalties.
Q: When is the deadline to comply?
A: The deadline is May 8, 2025. Reporters can start filing November 12, 2024.
According to the EPA, this timeline is meant to give manufacturers and importers one year to collect the information and then six months to report it.
Of note, small companies whose reporting obligations under this rule are exclusively due to PFAS importing will get a six month extension until November 13, 2025.
TSCA Rule Compliance Important Dates:
November 13, 2023 – Date TSCA rule takes effect
November 12, 2024 – Entities can start submitting reports to the EPA
May 8, 2025 – Deadline to submit all reports.
November 10, 2025 – Extended reporting deadline for small companies that only imported PFAS.
January 1, 2011 – Any person or entity that has manufactured or imported PFAS at any time after this date is required to comply with the new TSCA rule. Their obligation includes filing a report for every year going back to this date in which they made or imported PFAS, which in turn could require providing records that date back further, depending on each company's history.
Q: How do companies report?
A: The EPA is requiring all information be submitted electronically, similar to how information has been submitted under TSCA since 2013. Reporters must use the EPA's Central Data Exchange (CDX), which is the agency's electronic reporting portal, to submit all information under this rule.
Q: How much effort will be required to comply with the EPA's new PFAS rule?
A: Any person or entity required to comply must provide "all known or reasonably ascertainable information" for every category of record that is subject to reporting under the rule. Erring on the side of caution, our take on that is: if you have the records or can get them, they must be reported. It also means if you don't have records and/or can't get them, be ready to explain and show why not. Effort-wise, compiling and reporting all this information will require significant effort and a painstaking level of due diligence. PFAS manufacturers and importers will have to locate and collect what could be voluminous amounts of records and data. In total, the EPA estimates it will cost all affected industries a combined $800 million to undertake these efforts.
Q: How is the EPA defining PFAS?
A: There are more than 10,000 PFAS and it's not unusual for regulatory authorities to define them in different ways.
For the purposes of applying this rule, the EPA has also modified its definition of PFAS.
Instead of using a discrete list of PFAS, the agency is defining any chemical substance that has one of three specified chemical structures as a "PFAS" that must be reported.
Interestingly, this approach limits the number of PFAS subject to reporting but expands the definition and scope of the rule to include non-PFAS substances; it essentially acts as both a filter and a catch-all.
As a filter, the definition exempts less dangerous PFAS like single fluorinated carbon and unsaturated fluorinated moieties because they are not strong enough to pose a serious risk and would create unnecessary extra layers of work to include them.
As a catch all, it broadens to include both organic and synthetic non-PFAS chemical substances that, because of their structure and persistence, pose similar risks to PFAS but would otherwise go unreported if the scope had been limited to only PFAS or a discrete list of chemicals. Fluorinated ethers and butanoic acid are two such examples given in the EPA's rule.
Most importantly, however, using chemical structures rather than a list puts the onus on manufacturers and importers to determine if their chemicals meet the definition of PFAS under this rule.
As of right now, the EPA has identified 1,462 substances that meet the rules definition of PFAS.
For a further explanation of the three chemical structures the EPA is using to define PFAS for reporting purposes, please refer to [Figure 1].
Q: Who is required to report?
A: Any person or entity that has manufactured or imported a PFAS for a commercial purpose — this includes the coincidental manufacture of PFAS as byproducts or impurities — in any year since January 1, 2011.
Q: Who is not required to report?
A: Any person or entity that has only processed, distributed, used, and/or disposed of PFAS is not required to report under this rule, unless they also manufactured or imported PFAS for a commercial purpose.
Q: What kinds of information must be reported?
A: Examples of information the EPA wants reported include but are not limited to:
- All existing information concerning the environmental and health effects of a reportable chemical substance.
- Consumer and commercial use information, including files maintained by the manufacturers and importers, such as marketing studies, sales reports, or customer surveys.
- Chemical specific information, including Chemical Abstracts Index names, Chemical Abstracts Service Registry Numbers, and information contained in standard references showing use information or concentrations of PFAS in mixtures, such as a Safety Data Sheet (SDS), or a supplier notification.
- Company and plant site information, including information from the CAS or from Dun & Bradstreet (D–U–N–S).
Furthermore, it should be noted that "all existing information concerning the environmental and health effects" means "any information of any effect of a chemical substance or mixture on health or the environment or both" and is intended to be interpreted broadly. This includes information on the chemical substance developed or generated prior to the year 2011.
Q: How much information must be reported?
A: According to the EPA, manufacturers must report all information known to or reasonably ascertainable to them. 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."
If a manufacturer does not have actual data, they should consider whether "reasonable estimates" of such information are ascertainable. Such examples include mass balance calculations, emissions factors, or best engineering judgment.
Of note, article importers and small-scale manufacturers will have streamlined reporting forms.
Something else to consider: it's not unreasonable to think that satisfactory compliance with this rule could be determined in part by the quality and quantity of information an entity provides in comparison to what other entities provide. Meaning, if you offer less data and/or less clear data than everyone else, it could standout negatively or draw rebuke.
Q: What about submitting confidential information?
A: Any person submitting information can make a confidentiality claim. However, there is long list of information that is exempted from that protection.
Q: How is Actalent positioned to help companies comply?
A: The scope of these reporting requirements feels like a lot. That's because it is. Rest-assured, Actalent's regulatory experts and consultants are ready to guide you through it. We're already delivering successful outcomes doing the same work helping companies comply with Europe's REACH regulations. Working directly with your company, we'll do the heavy lifting when it comes to verifying and gathering all required TSCA information. We'll also prepare all necessary reports for EPA submission that are complete, accurate, and on-time. That way you can focus on core business without having to worry.
"How the EPA is Defining PFAS using Three Chemical Structures"
The new rule is limited to PFAS that are considered a "chemical substance", which the EPA has defined 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.
Thus, the EPA is defining PFAS as any chemical substance that has 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.
The EPA's definition of PFAS covers 1,462 known substances including fluoropolymers and higher MW fluoropolymers. However, it does not include substances that only have a single fluorinated carbon, or unsaturated fluorinated moieties e.g., fluorinated aromatic rings and olefins.
Again, it's important to note that the EPA's definition of PFAS differs from that of other regulatory bodies.
It's also important to note that even though the EPA's definition of chemical substance excludes mixtures, PFAS as a chemical substance may be present in a mixture. Therefore, this rule still requires reporting on each chemical substance that is a PFAS, including if it's a component of a mixture.