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EPA PFAS Announcement: TSCA PFAS Requirements Published 

The long-awaited announcement from the U.S. Environmental Protection Agency (EPA) on per- and polyfluoroalkyl substances (PFAS) under Section 8(a)(7) of the Toxic Substances Control Act (TSCA) came out on September 28, finally addressing some of the manufacturing industry’s pressing questions about PFAS requirements in the U.S. market. Currently, manufacturers are awaiting the publication of the final rule in the Federal Register. 

While there were already numerous PFAS regulations across the globe, including at the U.S. state level, this EPA PFAS announcement will affect the entire product compliance regulatory landscape.  

Register for Assent’s webinar, Unpacking the Recent Announcement on PFAS Requirements Under TSCA on October 12, to learn how to protect your business from the disruptions caused by this new federal rule. 

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This article summarizes the regulatory requirements laid out in the new EPA PFAS announcement, along with the top three market impacts your business needs to be ready for. If you’re not ready to meet the requirements, you face massive disruption risks. 

New EPA PFAS Requirements Explained

TSCA obligates the EPA to monitor and phase out hazardous chemicals in the U.S. market. PFAS chemicals are known to be persistent and bioaccumulative — according to national health authorities, approximately 97% of Americans have PFAS in their bloodstreams.  

The new rule will require manufacturers to collect historical supply chain PFAS data and roll it up into PFAS reports. Some of the data required includes (but is not limited to) : 

Which PFAS Are Covered?

The EPA has provided a definition for which PFAS must be reported under section 8(a)(7). Matching this definition against the TSCA Inventory and Low Volume Exemption claims,  the EPA has identified 1,462 PFAS chemicals, with half of those actively being used in the U.S. market. All PFAS that meet the EPA’s definition for this rule must be reported, even if they are not currently on the TSCA Inventory or claiming a Low Volume Exemption. 

Who Is in Scope of the New TSCA PFAS Requirements?

The new TSCA section 8(a)(7) PFAS reporting requirements cover businesses that manufacture or import, or have manufactured or imported, PFAS since January 1, 2011. This includes importation of PFAS that have already been incorporated into articles, such as articles containing PFAS as part of surface coatings or included in electrical equipment. There are no de minimis exemptions for small volume importers or small businesses. 

However, the EPA’s final PFAS reporting rule did streamline reporting requirements for manufacturers that only import PFAS in articles, and for businesses that only make or use small quantities (under 10 kg) for research purposes.

Waste management activities involving the importation of municipal solid waste streams for disposal or destruction, as well as some federal agency activities, are not covered by the reporting requirements.

What Are the TSCA PFAS Reporting Requirements?

Manufacturers will have eighteen months from the rule’s publication in the Federal Register to submit data to the EPA. Small businesses (as defined at 40 CFR 704.3) are not exempt, but the EPA is providing them with an additional six months to report, giving them a total of 24 months to collect and report their PFAS data. Depending on whether a manufacturer needs to use the full form or one of the streamlined forms for article importers or R&D purposes, different data sets may be required. Most businesses will need to report company and plant-site information, chemical-specific information (including CASRN identification number), categories of use of the PFAS, concentration or volume of the PFAS (or imported article), and other article data (if applicable). 

This reporting must be done for each year since 2011. All in-scope businesses will need to submit PFAS data using the EPA’s Central Data Exchange (CDX) electronic submission system. 

It’s important to note that the EPA stresses “…this rule is not a product testing requirement.” They indicate that manufacturers may be required to make inquiries outside of the organization to both suppliers and customers in order to fill gaps in knowledge. Per the EPA, “this standard carries with it an exercise of due diligence.” It will likely take manufacturers months to survey supply chains for PFAS use, making reporting timelines tight — not only for the EPA’s reporting requirements, but those in states such as Maine, which will also be due during the same timeframe as the EPA’s reports. Assent’s automated supplier engagement solution can help.

How Does the Final TSCA PFAS Rule Compare to the 2021 Proposed Rule?

The final rule on per- and polyfluoroalkyl substances (PFAS) reporting and recordkeeping requirements under TSCA is largely unchanged from the proposed rule, with some key differences:

  • The definition of PFAS under the final rule varies slightly from that in the proposal, resulting in a slightly higher number of chemicals on the TSCA Inventory and Low Volume Exemptions that meet the new definition. Substances that meet the definition, but are not currently listed on the Inventory or LVE list, are still required to be reported.
  • The final rule provides additional time for data collection — 12 months instead of the six months in the proposal. Followed by a six-month reporting period, this leaves manufacturers with 18 months total from the effective date to collect and report data.
  • While the final rule did not exempt small businesses from being required to report, those that meet the given definition are provided with an additional six months, giving them 24 months total from the effective date to collect and report data.
  • The final rule includes a streamlined reporting form option for businesses that only import articles and manufacturers of PFAS for research and development. Furthermore, for companies using the “full option,” some previously-required data elements have been removed.
  • The final rule provides the ability for “joint submissions” between suppliers and customers in the case of confidentiality concerns. Note this is not available for companies using the “streamlined” option.

Top 3 Impacts of the EPA PFAS Announcement 

1. Brace for Increased Customer PFAS Data Requests 

Expect a surge in customer inquiries about your product’s components and PFAS compliance. Customers that were waiting until the last minute and for an official EPA announcement will now be demanding PFAS declarations from your business as fast as possible. Companies are expecting “no PFAS” declarations to show their due diligence as much as those that identify where PFAS are located.

Failing to respond quickly can seriously harm your bottom line as buyers rapidly swap out suppliers for those who can prove compliance more quickly. Prepare for some major market shakeups based on who has the best access to data and the ability to communicate it downstream.

To retain your customer base, it’s crucial to have your data ducks in a row so you can respond to requests quickly, and that means having a solution in place to roll up your supply chain PFAS data for product-level reporting requirements. Assent’s PFAS compliance solution automates your supplier outreach to rapidly survey them on PFAS usage, giving you the urgent data you need to stay ahead of rising customer requests. Assent’s product compliance solution allows you to quickly assess which of your products contain PFAS based on your purchased components.

2. Regulatory Uncertainty Is Being Addressed — But Stay Vigilant

Many manufacturers have been feeling adrift waiting for an official announcement from the U.S. EPA. And while they waited, many states — including California, Colorado, Maine, and Minnesota — continued to enact their own PFAS regulations. This created a more complex regulatory landscape.

While the EPA’s TSCA PFAS announcement provides clarity on some of the near-term, federal-level PFAS requirements in the U.S., it’s essential to stay informed about state-level regulations and regulations for any other global markets you serve. The federal TSCA PFAS ruling sets a new baseline for reporting, but many states are not only enacting their own additional reporting requirement and fee structures, but product and usage restrictions as well.

For example, pay close attention to states that have enacted a blanket ban on PFAS in certain product categories such as infant products or food packaging, or even fulsome PFAS in product restrictions for anything other than unavoidable uses. 

Assent’s PFAS compliance solution is grounded in regulatory expertise and backed by a team of regulatory researchers who ensure our platform is up to date with current PFAS requirements for TSCA, as well as other global regulations like the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation or the Stockholm Convention on Persistent Organic Pollutants (POPs). We also provide managed services, expert guidance, and supplier education to help you be confident in your data, even when the regulatory landscape is full of uncertainty. 

3. Prepare for Intensified Competition for PFAS-Compliant Parts & Suppliers

The new requirements will trigger a race for both existing stock (before suppliers obsolete PFAS-containing materials) and PFAS-free stock (as everyone shifts to new sources at the same time), driving competition for parts through the roof as manufacturers complete last-time buys or get ahead on new materials. This will affect both delivery and price. Having detailed information about your PFAS usage and what’s coming from your supply chain is vital to getting a head start on identifying where your supply chain risks may be and securing the materials you need.

There’s already scarcity on the horizon: Due to investor and liability pressures, coupled with decreased demand, major chemical manufacturers like 3M have already announced they’ll be discontinuing PFAS products. This EPA TSCA PFAS announcement may force smaller businesses to make some tough decisions about their own product lines.

PFAS restrictions are also affecting manufacturing processes and facilities. Your maintenance, repair, and operations (MRO) may depend on a PFAS product, such as o-rings or gaskets, that may need to be swapped out for compliant alternatives. PFAS chemicals may also be required in processes like electroplating. You will need to evaluate whether any MRO-related purchases in your supply chain contain PFAS, and validate whether they are subject to new federal or state reporting requirements. In some cases, you may need to make capital investments to update or even replace entire pieces of equipment that are incompatible with compliant alternatives.

See how Assent’s PFAS solution lets you uncover hidden PFAS in your supply chain.

Schedule a demo today

Engage Your Suppliers for PFAS Data Now, If You Haven’t Already

Some proactive manufacturers are already collecting supply chain PFAS data so they can be ready to address customer concerns. If you were one of the businesses waiting for the EPA to make a move, this is your sign to implement a solution that engages your supply chain and collects PFAS data. Without visibility into PFAS in the materials you purchase, you risk losing customers and face part shortages and increased delivery and cost. A proactive approach is the only way to protect yourself from disruptions in the wake of this new EPA PFAS announcement.

Assent’s PFAS solution solves for your PFAS compliance requirements by automating supplier outreach to collect vital PFAS data, centralizing your product data, and rolling up your compliance information to your finished products and into PFAS declarations. You get higher quality and more reliable data from your supply chain in less time, helping you avoid disruption as the industry rapidly accelerates toward stricter PFAS restrictions.

Don’t wait! Take a product tour of Assent’s proactive PFAS compliance program now.

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Unpacking the Recent Announcement on PFAS Requirements Under TSCA

Post-Webinar FAQ

When does the PFAS reporting rule become effective?

The portal for reporting will open on November 12, 2024, and will be due by May 8, 2025. “Small manufacturers” (as defined by the regulation) will have until November 10, 2025, to finish reporting.

Is there a PFAS concentration threshold level that exempts you from reporting as long as you are below it?

No. There is no de minimis associated with this regulation or low volume exemption.

Do air conditioner gasses need to be reported?

Many refrigerant gasses (F-gas) do not meet the Environmental Protection Agency (EPA) PFAS definition. Products containing air conditioning gasses WILL need to be registered with U.S. states such as Maine and Minnesota that have registration requirements for products containing “intentionally added PFAS.”

Are alcohol-repellent fluorocarbon (FC) treatments included in the definition? And for what type or chemical structure?

Most chemical-repellant fabric treatments are PFAS-based. Please check with your supplier.

Are all of the banned uses of PFAS actually hazardous to human health?

TSCA Section 8(a)(7) is not a restriction but rather a reporting rule. One of the EPA’s stated objectives of the rule is to grow their understanding of which PFAS are used in the U.S. and for what purpose; this may inform future test and research strategies, which will provide more information about which PFAS are linked to human health effects.

Are fluoropolymers included?

Yes, the EPA specifically includes fluoropolymers in the text of the law: “EPA is also affirming that fluoropolymers which meet this rule’s definition of PFAS are reportable under this rule; this includes higher molecular weight fluoropolymers. The 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.”

Are food contact products, such as drinkware (e.g., mugs) excluded from reporting as well?

Cookware and food service products ARE in scope for PFAS reporting. One exception to TSCA overall is FDA-approved products such as medical devices; however generally food contact products do not require specific FDA approval so they would not be exempt from TSCA. Furthermore, these types of products are also included in numerous state laws that are already in effect or will take effect soon.

Are imports through the internet covered by the rule?

Yes. Any imported goods may be subject to reporting (i.e., materials, parts, assemblies, or products that are NOT regulated by another federal agency, such as the Food and Drug Administration [FDA]), regardless of how they were purchased.

Are packaging materials in scope?

Yes.

Are pesticide devices included in the exemption?

Products that are subject to FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act), whether imported or domestically produced, are out of the scope of TSCA. If your products are not in scope of FIFRA, they may be required to be reported under this regulation. See more here.

Are products regulated under the FDA (e.g., medical devices out of scope of this reporting requirement)?

Products that are out of the scope of the Toxic Substances Control Act (TSCA) do not need to report PFAS. Medical device manufacturers may need to report on PFAS they may import that are not classified as FDA-regulated products.

Are there any common fluoropolymers excluded from the scope of the regulation (e.g., for article imports)?

The EPA specifically includes fluoropolymers in the text of the law: “The EPA is also affirming that fluoropolymers which meet this rule’s definition of PFAS are reportable under this rule; this includes higher molecular weight fluoropolymers. 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.”

Are the same substances considered PFAS in America and Europe?

The definitions are not harmonized and must be evaluated separately.

By “need to report,” do you mean to the EPA or are you talking about answering questions to your customers for their own reporting?

“Need to report” here relates to the EPA reporting, but customers may also ask about PFAS to evaluate their risks related to these substances.

Can a FMD be submitted as a replacement for PFAS?

It depends on who is requesting PFAS information from you and in what format. Note that many FMD declarations often withhold a certain percentage of information as “proprietary,” and this is often where PFAS may be listed. As the majority of PFAS are not currently deemed “hazardous” under the UN Globally Harmonised System (GHS), they may not be required to be disclosed on FMD documents. The same situation occurs with PFAS being listed in Safety Data Sheets (SDS).

Can a headquarters report in the Central Data Exchange (CDX) for multiple facilities within a corporation?

Yes.

Can we continue importing articles with PFAS until we find an alternative, as long as we report it?

Yes. TSCA section 8(a)(7) — PFAS Reporting — does not impose restrictions. However, note that numerous state laws may impose separate restrictions on the use of PFAS in products sold in those states.

Can you only detect PFAS with specific testing, or could a full material disclosure (FMD) identify what we need to meet different PFAS regulatory requirements?

The EPA has been explicit that this is not a testing requirement. An FMD may be sufficient, although it’s not explicitly referenced in the rule. However, note that many FMD declarations often withhold a certain percentage of information as “proprietary,” and this is often where PFAS may be listed. As the majority of PFAS are not currently deemed “hazardous” under the UN Globally Harmonised System (GHS), they may not be required to be disclosed on FMD documents. The same situation occurs with PFAS being listed in Safety Data Sheets (SDS).

Can your software LINK with your customers’ ERP system?

Yes, the Assent Sustainability Manager uses a rest application programming interface (API) to connect to enterprise resource planning (ERP) and product lifecycle management (PLM) systems.

Did the OECD publish the complete list?

The OECD list may help, but the OECD’s definition for PFAS is not the same as EPA’s definition. It includes 4,730 different PFAS chemicals (although it hasn’t been updated in recent years).

Could you post the link for the Bloomberg article for U.S. states?

PFAS State Activity Tracker

An additional (free) resource for state regulations can be found at saferstates.org.

State laws can be tricky to follow given different government structures between states, so keep in mind that no resource may always be complete and up-to-date; these recommendations are for reference.

Do fluoropolymers like polytetrafluoroethylene (PTFE), fluorine kautschuk material (FKM), perfluoroelastomer (FFKM), ethylene tetrafluoroethylene (ETFE), and fluorinated ethylene propylene (FEP) meet the EPA’s PFAS definition?

Yes.

Do foreign manufacturers have to report themselves, or are they just affected “indirectly”?

The reporting obligations fall to the “importer of record,” which may be the foreign manufacturer or their customer. In either case, the responsible entity will have to provide PFAS data.

Do I have to report imported PFAS-containing articles when used for the manufacture (done in the U.S.) of products for non-U.S. markets?

Likely yes, as TSCA’s definition of “distribution in commerce” includes import and movement within the U.S., even between your own facilities.

Do I report the PTFE seal tape I sold at a yard sale?

If you ordered it on Temu from China, then yes, you would.

Do perfluoropolyethers (PFPE) meet the EPA’s PFAS definition?

Yes, fluoropolymers (including PFPEs) meet the EPA definition of PFAS.

Do products made with iron alloy containing lead atoms need to be reported?

Leaded iron alloys do not need to be reported under this rule, unless they have a PFAS-containing surface treatment.

Do these PFAS requirements apply to consumer goods?

“There is no differentiation in the regulation between applicability for consumer versus industrial uses. The EPA is requiring data on ALL uses of PFAS: “The requirements of this part apply to all chemical substances and mixtures containing a chemical substance (including articles) that are a PFAS, consistent with the definition of PFAS at § 705.3.”

This is different than the CPSC request for information, which was specifically for consumer products.

Do we have to report for facilities that were open in 2011 but are now closed?

The regulation states, “For each year since January 1, 2011, the total amounts manufactured of each PFAS, including the amounts manufactured in each calendar year for each category of use.” There is no exclusion for now-closed facilities.

Do we have to report on obsolete products?

This is not a product-reporting rule. You must report on all manufacture of PFAS, including PFAS that is incorporated into imported articles (such as a coating), since 2011. Even if those imported articles are no longer being reported, you would need to report for each year (beginning in 2011) that they were imported.

Do you have links to the state-level regulations (46 states with PFAS action)?

View the site managed by Bloomberg Industry Group that was mentioned during the webinar, visit here.

Do you have to report all PFAS from 2011 to present?

For a start date, the rule requires reporting, by year, back to 2011. This was included in the Congressional mandate to the EPA as part of the National Defense Authorization Act for FY2020 and the EPA was bound by law to keep that as the starting date in the final rule.

As for the end date, EPA does not provide a concrete “end year” for the reporting period. There are a few places where you might infer the end date, however. First, you may logically deduce that that 2022 is the last full year required for reporting from the section about “who must report.”

§705.10 Persons who must report. Persons who have manufactured for commercial purposes a chemical substance identified in § 705.5 at any period from January 1, 2011, through the end of the last calendar year prior to November 13, 2023, except as described in § 705.12, is subject to the requirements of this part. However, technically this section is not about the data that must be reported.

Separately, in the section titled “G. What are the requirements for submitting CBI claims?”, EPA makes reference to the reporting rule covering 11 years (page 13 of 44) – “… In light of the extended timeframe (11 years) covered by this reporting rule, it is possible that the submitter’s supplier is unknown or no longer exists…” Using a “starting year” of 2011, this would mean the last full year of reporting would be 2021, not 2022 as one might infer from the statement about “who must report”.

It’s advised that in the absence of further clarification from the EPA (which may yet be forthcoming), you review this target date with in-house counsel. Given that state reporting obligations will be based on current data without the “look-back” of this TSCA section 8(a)(7) reporting rule, and since most manufacturers will need to comply with state reporting as well, it would be practical and a best practice to collect data from 2011 through the present. If the EPA hasn’t already confirmed the end date by November 2024, when the portal opens up for reporting, it will likely be clarified at that time.
https://www.govinfo.gov/content/pkg/FR-2023-10-11/pdf/2023-22094.pdf

Do you know when we can expect the streamlined reporting option for imported articles to get a better understanding of how to report PFAS in articles ?

The EPA has included the specific details required for reporting in this streamlined form. Please check the published final rule, section 705.18, which starts on page 40 of 44 in the final rule as published.

Do you report through the EPA website?

Yes. The EPA requires PFAS reporting through its CDX platform.

Do you still have to report on articles that were imported in 2011, but have long since been end-of-life products?

Yes, if the obsolete products were sold between 2011–2022

Do you prepare the report for us to submit to the EPA?

Assent collects the required substance data from suppliers or manufacturers, which will need to be meshed with your annual sales or import volumes.

Does a list that includes CAS numbers for in-scope PFAS exist?

The EPA has not provided a list of specific substances, just an estimate of how many substances on the TSCA inventory or with low volume exemptions (LVE) will meet the definition. They are very clear that substances that meet the definition that are NOT on the inventory or with LVE must still be reported.

Does the EPA require PFAS reporting for packaging material?

Yes. Packaging materials containing PFAS are in scope, unless the packaging is regulated by another federal agency (such as the FDA for pharmaceutical packaging).

Does the EPA publish the PFAS list that is covered by the reporting rule?

The EPA has not provided a list of specific substances, just an estimate of how many substances on the TSCA Inventory or with an LVE will meet the definition. They are very clear that substances that meet the definition and are NOT on the inventory or have an LVE must still be reported.

Isye packaging material within the scope of the rules?

Yes. Packaging materials containing PFAS are in scope, unless the packaging is regulated by another federal agency (such as the FDA for pharmaceutical packaging).

Does the import obligation to report apply if the PFAS are ultimately part of a medical device?

You likely need to report if imported PFAS-containing parts or materials are not classified as medical devices. U.S. state-level product registration will include medical devices that contain PFAS.

Does the amount (%) need to be reported, or just whether it contains PFAS?

Reporting requires weight and/or weight percentage, along with annual import volumes

Does the federal regulation apply only to intentionally added PFAS?

The phrase “intentionally added” is not a factor in this reporting rule, nor is it used on the rule itself. The purpose of the rule is for the EPA to understand which PFAS are being used in the United States, and for what purpose. The EPA provides an answer to the comments they received suggesting that “intentionally added” be a consideration on page 19 of 44 in the Federal Register publication.

Does the reporting requirement include PFAS concentration levels? Or just which PFAS might be used?

This is dependent on whether you are reporting using the streamlined “article importer” form, which has more allowances for how to count “volume,” or the full form.

Does the reporting scope include privately held companies?

Yes, there is no differentiation between private versus publicly held companies in this rule. TSCA has no oversight from the SEC.

Does the rule apply to discontinued products?

Yes, the TSCA reporting rule applies to PFAS manufactured or imported from 2011 through 2022.

Does the rule take effect 30 days from adoption/publication/other?

The TSCA PFAS reporting rule is effective November 13, 2023, with reporting due for most PFAS manufacturers and importers by May 8, 2025.

Does the scope (report on PFAS in imported articles) include industrial products?

Industrial products are in-scope for EPA PFAS reporting, unless the products are governed by another federal agency (e.g., the Nuclear Regulatory Commission or the FDA).

Does this apply to the casting/forging manufacturing businesses?

PFAS substances used in the casting/forging industry would be in-scope for reporting.

Does this only apply to manufacturers of PFAS or products containing PFAS?

All PFAS that are directly manufactured in the U.S. will need to be reported with the exceptions noted in the rule.

“Products” that only use domestically-sourced PFAS materials (either on their own or in products) do not need to report as downstream users. However, “product” manufacturers who import PFAS, either as substances/mixtures or already incorporated into articles, will need to report on their imported materials

Dr. Bruce mentioned the grease (e.g., Krytox) contains PFAS. As a manufacturer, I buy Krytox (whether sourced in U.S. or outside of U.S.). In my view, I am not buying PFAS, I am buying a finished product called Krytox. Do I have to report anything? I may not even know that Krytox contains PFAS.

Krtox is a perfluoropolyether (PFPE)-based grease, and as such, Krytox grease meets the EPA definition of PFAS that requires reporting. Raw chemicals, mixtures, and articles (parts) that contain PFAS are subject to this reporting rule.

The European Chemicals Agency (ECHA) said that if the total fluorine is less than 50 ppm, then no further testing is necessary.

Correct.

Fluoropolymers are in scope of the regulation, but certain ones could be excluded by definitions?

Correct. While most common fluoropolymers meet the EPA definition, certain polymers may be excluded.

For a company that imports some of our products Delivery Duty Paid (DDP) to our customers (where the customers are the Importer of Record), would our DDP customers need to be the ones to report their DDP shipments?

Correct. As importer of record, your customers are responsible for PFAS reporting, and may likely ask you for the required information.

Does the EPA TSCA rule alone apply to all U.S. states, or do states have their own requirements?

Approximately 46 U.S. states have proposed or adopted legislation regulating PFAS, including bans in certain product categories and product registration requirements.

For product-level PFAS disclosures, our customers direct us to use certain suppliers — do we still need to reach out to those suppliers?

This may depend on the Terms and Conditions in your customer contracts, and on which company is the importer of record for PFAS-containing mixtures, parts, assemblies, and products.

Fundamentally, these reporting requirements remind me of conflict mineral requirements. Meaning, should we check with all suppliers to ask if they use PFAS on any product/service sold that goes on/in a product sold?

Rather than engaging suppliers twice, you might lead with this question and follow with “if yes” questions to collect the required supplier data for reporting.

Has Assent been able to locate the list of 1,462 PFAS that are in scope as referenced in the rule?

The EPA has not provided a specific list, but the agency instead refers to the TSCA Inventory (dating back to 2006) and substances with LVEs. Assent’s team of experts has used these resources along with guidance from the June 2021 proposal to create a list of in-scope PFAS chemicals

Are food contact materials in scope of these requirements?

Food contact products, such as cookware and food service equipment, ARE in scope of PFAS reporting requirements

How are distributors to obtain the information they need since they do not manufacture? Is a safety date or material data form supplied by a manufacturer acceptable?

Correct, distributors will need to engage product manufacturers to collect the required data for EPA reporting

How confident are you that suppliers will actually know their products contain PFAS? My initial thought is that most do not know. How can they report to you if they are unaware?

PFAS is a new topic to many manufacturers and suppliers, so education (the what, why, and where of PFAS substances) will be critical to obtaining quality data.

How does this apply to acquisitions? What if we bought a company in 2017? Do we still have to go back to 2011 for their records?

Yes, PFAS introduced into U.S. commerce from 2011 through 2022 must be reported, to the best of your ability.

What about acquisitions done after 2011? Are we responsible for reporting if we didn’t have ownership for some of those years and don’t have all the right data?

I recommend that you review the obligations for acquisitions with in-house counsel. It is likely that you will be responsible for that reporting based on other legacy obligations under laws like CERCLA; however, in-house counsel can advise on these legal obligations.

The rule does make allowance for incomplete data after you have completed due diligence. They state for manufacturers with partial data: “If, after reasonable inquiry has been attempted, manufacturers don’t know nor can reasonably make estimates for certain data elements, they may indicate such information is ‘Not Known or Reasonably Ascertainable’ (NKRA) to them when completing reports.”

How is Assent going to handle CDX submissions, since you rely on the IPC protocol?

This is the wrong CDX. You are confusing the “Compliance Data Exchange” with the EPA “Central Data Exchange.”

How will the EPA enforce reporting, and is there a penalty for not reporting even if it’s unintentional? Having to go back to 2011, what if the supplier is no longer in business?

TSCA violations impart a penalty of $50,000 USD per incident per day.

I am not importing but selling products to the U.S. that might contain PFAS (facility in Canada). Do I have to report or is it my customer who has to report? I am just selling products.

Either you or your customer will need to report, depending on who is the importer of record into the U.S.

I buy PFA granules from an American manufacturer and process them in Europe into a laboratory article — let’s say a beaker or a bottle — and then sell this bottle to a dealer in the U.S., who is responsible for reporting? The importer into the U.S.?

Correct, the U.S. importer of record is obliged to report.

I have three products (components supplied to my company) that contain PTFE. Does this fall in the “must report category” at the component level? Or is that only when we put the final product in the market (which would be a sale to a tier one customer that sells the customer market- vehicle)?

If the components are imported into the US, that would be the point at which the reporting obligation exists. If they are exported downstream and then reimported further downstream, then an additional reporting obligation would exist at that point as well.

I manufacture parts in Mexico that contain PFAS, and I ship the parts to my original equipment manufacturer (OEM) in the U.S. for vehicle assembly. Is it the customer’s responsibility to report PFAS or mine?

If the OEM is the importer, then they have the obligation to do the reporting.

How do we define this in a declarable substance list (DSL) when there is no list?

A free response option for “Other PFAS” must be available for PFAS beyond what exists on the list, but it must meet the definition under TSCA.

If a company buys a PFAS product domestically, is the company still required to comply with this new rule? Or would this rule ONLY apply to imported articles?

Solely purchasing PFAS products domestically carries no reporting obligations.

If a company is headquartered in the U.S. but PFAS-containing articles are purchased, used, and sold at overseas sites, would they have to be reported?

No. Only PFAS substances that are placed into the U.S. commerce need to be reported.

If a distributor imports a PFAS-containing article and resells it at a profit, are they in scope of the EPA’s reporting requirements?

If they import an article containing a PFAS, they have the reporting obligation. Full stop

If Company A manufactures an article using PFAS-containing chemicals that were manufactured by Company B in the U.S., does the reporting requirement apply to Company A for the article?

The obligation rests with Company B

If the country of origin of a component is other than the U.S., but is purchased on the U.S. market, do we have the reporting obligation?

Products, parts, and mixtures that contain imported PFAS and are sourced domestically will be reported to the EPA by the original importer

If I buy an industrial product that contains PFAS from a manufacturer outside the U.S. and they import it for me and I sell it to customers in the U.S., am I required to report to the EPA?

The imported industrial product that contain PFAS must be reported to the EPA by the importer of record.

If I buy PFAS-containing industrial products through an importer and I sell it to customers in the U.S., am I required to report?

The imported industrial products that contain PFAS must be reported to the EPA by the importer of record.

If I purchase a copper bar from Germany and they used a coolant or hydraulic fluid in the cutting of the metal, leaving just a surface residue, would that need to be identified and reported if the surface residue contained PFAS?

Machined metals and alloys are customarily cleaned prior to shipment, so PFAS residue might reasonably be negligible, unless the metal receives an applied PFAS-containing antioxidant coating.

If I’m reporting for my entire supply chain, and they are also reporting to others in their supply chain, aren’t we grossly over-reporting ?

The EPA seeks to avoid duplicate reporting. Companies should report PFAS substances that they manufacture, or where they are the importer of record. This includes PFAS incorporated in mixtures, parts, assemblies, and products.

Are components manufactured for medical devices exempt from TSCA?

Parts and materials used in the domestic U.S. manufacture of medical devices may likely be in scope of TSCA. Please check with your legal counsel.

If my final product (cured article) contains any PFAS and does not affect the environment or humans, do we still need to report?

Yes. All PFAS substances in U.S. commerce from 2011–2022 must be reported, regardless of health or environmental hazard classification.

If our company has not imported PFAS articles since 2011, how do we present our due diligence to the EPA? In CDX?

If you have not imported PFAS articles since 2011, there’s no need to report to the EPA. Please document your due diligence internally

If our product contains a component that has PFAS and that component is NOT manufactured in the U.S., are we responsible for the reporting?

Article importers are defined as “manufacturers” for the sake of this rule. This means that you will have to report on any PFAS you are importing, even if it’s already incorporated into an “article” (such as a coating).

If you are sourcing PFAS domestically within the U.S., then you, as a downstream user, will NOT need to report it.

If our product mounts a FKM gasket, are we allowed to sell in the U.S.? Only reporting is required?

Yes, FKM rubber gaskets are allowed for sale in the U.S., and only reporting is required.

If PFAS are not listed on a safety data sheet, how can they be identified?

The rule specifically talks about making inquiries to upstream suppliers and downstream customers to collect information.

If PFAS was added to an article, but is no longer there, would you still have to report it? In other words, does the intentional addition of PFAS automatically trigger reporting?

The presence of PFAS triggers a reporting requirement. Removal of the PFAS, perhaps present in a rust-inhibitory coating, begs the question where this activity occurred — within the U.S., after import, or prior to importation. If the PFAS removal occurred after import, the PFAS would require reporting and likely tracking of its deposition.

If products containing PFAS are exported, do we have to report as well if it is made in the U.S.?

Yes, if the PFAS was in U.S. commerce (including transportation or use) during manufacture.

If PTFE is in the packaging vent and gaskets, like an IBC, is it the responsibility of the IBC maker to report, or the filler of the IBC, or both?

The U.S. manufacturer of the PTFE, or the importer of the PTFE, is obliged to report. The EPA wants to avoid duplicate reporting.

Even if a device is out of scope, are processing aids or manufacturing equipment in scope of the reporting requirement if they contain PFAS?

Imported manufacturing parts (MRO) and indirect materials may likely be in scope of PFAS reporting

If the PFAS is purchased and the vendor chooses to ship from domestic and international locations, is the reporting requirement on my company or theirs? Does it boil down to the importer of record (IOR)?

Reporting obligations do fall to the IOR, though the terms and conditions of your contractual relationship with the importer (perhaps a brokerage or agent) may transfer that responsibility to you as the customer.

If the supplier incorrectly reports PFAS amounts, is the liability still on the importer to ensure the information is correct?

Retain your supplier documentation for at least five years, as required by the EPA. Signed supplier declarations on their letterhead provide affirmation and documentation of your due diligence.

If the supplier lists the materials as “confidential,” how do we know if there is PFAS in the product?

Your supplier should have a legal obligation to declare the presence (and identity) or absence of PFAS fluorocarbons, per the terms and conditions of your supplier contract. You are asking for substance disclosure, not their confidential business information.

If TSCA does not require reporting for domestic components, do we still need information on these parts to meet state-level requirements?

Correct. We recommend collecting PFAS data from both foreign and domestic suppliers/contract manufacturers.

If we are purchasing PFAS produced outside the U.S. through a U.S. distributor, do we have the reporting obligation?

It is likely the distributor has the reporting obligation

If we buy a gasket containing PFAS that is imported by a local distributor, does this mean we don’t need to report since we are buying an imported component from a U.S. distributor?

In this scenario, you do not need to report. The reporting obligation falls to the distributor that originally imported the PFAS-containing gaskets

If we have obsoleted a product and no longer have a relationship with the product manufacturer, but the product was sold in 2011, do we need to still report?

Yes. Reporting is required for all PFAS introduced into U.S. commerce from 2011 through 2022.

If we import from our overseas location for export purposes, does this need to be included in the figures?

Yes, if those PFAS-containing products were introduced into U.S. commerce, which includes product movement to your U.S. facility.

If we import nothing, what is our obligation to report?

If you do not import anything AND you do not manufacture PFAS itself, then you likely have no reporting obligations

In the Assent platform, how live is the data for each bill of materials (BOM)? Also, how frequently are suppliers required to update declarations?

Customers can update their BOMs as needed, adding new products and/or suppliers. This is generally done prior to the next outreach, based on updates to the substance lists — for example, when the REACH Candidate List is updated twice a year. The frequency of outreach can be determined by your needs, including PFAS reporting periods.

Is fluorosilicone considered a PFAS?

Yes

Is reporting only required for intentionally added PFAS?

The phrase “intentionally added” is not a factor in this reporting rule, nor is it used on the rule itself. The purpose of the rule is for the EPA to understand which PFAS are being used in the United States, and for what purpose. The EPA provides an answer to the comments they received suggesting that “intentionally added” be a consideration on page 19 of 44 in the Federal Register publication.

Is the importer of record (IOR) responsible for the reporting of PFAS in articles?

Yes, the Importer of Record (IOR) is responsible for reporting PFAS contained in articles.

Is there an R&D exclusion?

No, R&D use of PFAS is not exempted. There is no de minimis threshold for EPA reporting.

Is there PFAS in Post-it Notes?

Please see here for more information on this.

Is PTFE (Teflon) in scope?

Yes.

Is the concentration level field on the Assent Supplier Portal optional? Some suppliers may want to provide declarations that would list the PFAS substance and CAS number, but not concentration.

Yes, our managed services team can work with each customer to determine if the concentration field would be required or optional.

Is the EPA concerned with all products that contain PFAS or are there any exemptions for products that are considered inert?

The EPA is collecting data on all PFAS substances to help with the its prioritization and risk evaluation of these substances.

Is the EPA going to provide any education for the supply chain?

The EPA has not yet announced PFAS education or training.

Is the importer of record (IOR) the only party responsible for reporting imported PFAS? For example, if a logistics firm acts as IOR, would they be responsible as opposed to their customer who procured the import?

The reporting obligation falls on the IOR. In your example, it may depend on the terms and conditions of the customer’s contractual relationship with the logistics firm (i.e., the burden may fall on their customer if their duties are primarily administrative).

Is the reporting on the amounts of PFAS on an annual basis (average) or total “used”?

PFAS must be reported on an annual basis for the twelve year period 2011-2022, inclusive.

Is there a detailed description of medical devices?

Medical devices are defined under Title 21 of the Code of Federal Regulations.

I import parts (articles) and finished goods. Will both need to be reported?

Importation of PFAS in articles and finished products requires reporting of those PFAS substances

Is this going to be a one-time report or should we expect annual reporting afterwards?

At this time, you only need to report once.

It this only a reporting obligation and not a restriction? Does that mean articles with PFAS will not be banned in the U.S.?

Not under this rule. However, there could be a federal-level restriction down the road, and there are state-level restrictions already in place.

My suppliers only provide compliance declarations for the last two years (REACH, RoHS, etc.). If they only retain documentation for 7–10 years, can I expect them to provide PFAS declarations as far back as 2011?

 You will need to estimate based on annual sales volumes, to the best of your ability.

Are there exemptions for companies that have not manufactured PFAS after 2011? Does this mean article producers are exempted?

Article manufacturers themselves MAY be in the scope. If they create any PFAS as by-products, they will be required to report those “new” PFAS. Secondarily, if they are IMPORTING PFAS, either on their own, or already incorporated into an article (such as in a surface coating or wire insulation), they will need to report the PFAS that are being imported. Note, the EPA provides a streamlined form that can be used for PFAS in imported articles under section 705.18. It’s best to discuss the level of due diligence required of you with in-house counsel. You should review all of the “due diligence” sections of the final rule.

If we survey our suppliers of goods we import, and they say they don’t know if they have PFAS and can’t afford to test, then what can we report? Have we done reasonable due diligence?

That said, based on the final rule for this particular law, the EPA is very accommodating and they understand that information may be difficult to obtain for article manufacturers: “If, after conducting due diligence and reviewing known or reasonably ascertainable existing information, a manufacturer, particularly an importer of articles containing PFAS, may not have knowledge that they have manufactured or imported PFAS and thus need not report under this rule. EPA encourages such an entity to document its activities to provide evidence of due diligence.”

Our finished product includes o-rings purchased in the U.S. that contain PFAS. Are we in scope or is the distributor/ manufacturer that sold this product to us in scope?

If you are sourcing it domestically, you are not in scope of the TSCA reporting rule. However, you will likely need to register your products containing PFAS for the state of Maine beginning in January 2025.

Please explain what “manufacturing” means. If a component containing PFAS is purchased in the U.S. and assembled into a finished product, is this considered “manufacturing” as defined by the rule? Is the finished product in scope for reporting? Or is it only in scope when the component containing PFAS is imported from outside of the U.S.?

Manufacturing relates to domestic synthesis of PFAS substances, and to the import of PFAS substances (including PFAS substances in mixtures, parts [articles], assemblies, or finished products) into the U.S.

Is there a substance and threshold list for this latest update?

The EPA has not provided a substance list, and there is no de minimis threshold (lower limit) for reporting.

Do PTFE hoses have to be declared?

Yes, if they are imported.

Say a PFAS-containing article is imported by a distributor and subsequently sold to a retailer — which party is required to report? The distributor? The retailer Both?

Only the distributor.

If we import articles such as electrical components, gaskets, or polycarbonate resins that may contain PFAS as a flame retardant, are we required to report? We do not have any specific knowledge of the substance, percentage, weight, or other details.

Yes, you would have the obligation to report under this rule

Regarding the other federal actions, are these only placed on manufacturers to date?

Each regulation has a different scope and reporting rules; you will need to review your exposure to other reporting obligations, reviewing each law individually. For example, TRI reporting may apply to both manufacturers and users of PFAS substances.

Various state laws require the disclosure of PFAS, which also includes providing a website for an authoritative list. Is there a preferred/mandatory website to use for online and label disclosure?

Unfortunately, U.S. states that regulate PFAS and/or require product registration have not provided substance lists. The definition of PFAS is not universally agreed-upon between states, and while some state laws identify specific PFAS chemicals and CAS numbers (like California Proposition 65), others provide very broad definitions and refer to the EPA’s more comprehensive CompTox list.

We apply coatings to parts. So we buy chemicals/paints that have PFAS in them from suppliers in the U.S. But we are an upstream supplier for our customers. It was mentioned that only the entity that puts the PFAS on sale first in U.S. has to report. So would we have a reporting requirement?

If you are sourcing PFAS domestically, you will not need to report those. The manufacturer of the PFAS chemicals themselves are supposed to report. Keep in mind, however, that if any of your processing creates byproducts that are PFAS, you would need to report those byproducts, as you’ve now “manufactured” a new PFAS.

We are an injection molding company and purchase materials from U.S. companies. Are we required to report or is just our vendors?

Purchasing from U.S. companies may be a gray area. Was the material you purchased manufactured outside the U.S. by a U.S. company? If everything you purchase is from a domestic source (not drop shipped or otherwise imported), then you likely do not have a reporting obligation.

We don’t manufacture any PFAS. However, we use PFAS in our product. Are we still responsible?

You will need to report on anything that you are importing, even if it’s already incorporated into an article (such as a coating). Anything that you source domestically will not need to be reported for this particular TSCA reporting rule. However, that will not be a factor when it comes to state-level reporting, such as in Maine; in such cases, PFAS must be reported regardless of whether it’s domestically sourced or imported.

We fabricate parts by injection molding process using fluoropolymer. Are we a manufacturer or processor?

If you purchase the resin domestically, you do not report. If you import the resin, you are required to report.

What if PFAS is not intentionally (for example, a release agent)?

The phrase “intentionally added” is not a factor in this reporting rule, nor is it used on the rule itself. The purpose of the rule is for the EPA to understand which PFAS are being used in the United States, and for what purpose. If you are importing the release agents, and they contain PFAS, they will need to be reported even if they are not part of any finished products. The EPA provides an answer to the comments they received suggesting that “intentionally added” be a consideration on page 19 of 44 in the Federal Register publication.

What if the manufacturers won’t be able to do retroactive reporting of PFAS, especially for those obsolete/EOL parts that are still used in assemblies?

The EPA addresses “due diligence” numerous times throughout the rule. For example, on page 6 of 44: “If, after conducting due diligence and reviewing known or reasonably ascertainable existing information, a manufacturer, particularly an importer of articles containing PFAS, may not have knowledge that they have manufactured or imported PFAS and thus need not report under this rule. EPA encourages such an entity to document its activities to provide evidence of due diligence. Additionally, consistent with their own business practices, companies may elect to retain documentation of their conclusion that they were not subject to reporting requirements.”

What is the definition of “manufacturing” (including importing)? We source and resell finished goods or components that may contain PFAS, rather than raw mixtures. Does the reporting requirement apply to us?

If you are importing materials (whether as substances, mixtures or articles) that contain PFAS, then you would need to report those PFAS. If you are purchasing them domestically, you do NOT need to report for TSCA Section 8(a)(7) unless you are also creating by-products that contain PFAS. You may still be obligated to report to various states such as Maine and Minnesota.

“Manufacturer” is defined several times throughout the rule. For example, from page 4 of 44: “Anyone who has manufactured (including imported) a PFAS for a commercial purpose in any year since January 1, 2011, is covered by this rule. As noted in Unit III.B.2, ‘‘manufacture for a commercial purpose’’ includes the coincidental manufacture of PFAS as byproducts or impurities. EPA believes at least portions of the NAICS codes listed in Unit I.A. may be covered by this rule. This rule extends to manufacturers (including importers) only. Importers of PFAS in articles are considered PFAS manufacturers.”

What is the reporting date?

The portal for reporting your imported materials will open on November 12, 2024, and will be due by May 8, 2025. “Small manufacturers” (as defined by the regulation) will have until November 10, 2025, to finish reporting.

What’s the definition of small business under this law?

“Small manufacturers” are defined as manufacturers who meet one of two standards:

  • 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 lbs.
  • A manufacturer (including importer) whose total annual sales, when combined with those of its parent company, are less than $12 million
What PFAS are in scope?

The EPA does not provide a specific list of chemicals in scope. Rather, they state that per- and polyfluoroalkyl substances or PFAS means, for the purpose of a part, any chemical substance or mixture containing a chemical substance that structurally contains at least one of the following three sub structures:

  • (1) R-(CF2)-CF(R’)R’’, where both the CF2 and CF moieties are saturated carbons
  • (2) R-CF2OCF2-R’, where R and R’ can either be F, O, or saturated carbons
  • (3) CF3C(CF3)R’R’’, where R’ and R”” can either be F or saturated carbons

The EPA has identified at least 1,462 chemical substances in the U.S. that meet the new definition based on the 2023 TSCA Inventory and Low Volume Exemption (LVE) claims. However, if a substance meets the definition but is not included on the Inventory or LVE list, it must STILL be reported.

What will be the auditing process for this reporting?

The EPA does not define any auditing requirements for this reporting rule.

What is the definition of the company who put it first on the market?

“Put on the market” is not a term relevant to this particular rule; this is not a product reporting rule but rather a PFAS-usage reporting rule. Any PFAS that are manufactured within the U.S. must be reported, including any PFAS that were created as a by-product during the manufacturing process.

Additionally, any PFAS that are IMPORTED must also be reported, whether as a substance, mixture, or incorporated into an article.

Domestically-sourced PFAS do not need to be reported by downstream users.

What is the penalty for not reporting or reporting incorrectly?

TSCA has a level of enforcement for “knowing or willful reporting violations” of up to one year in prison and $50,000 per day per violation.

“TSCA section 15(3) makes it unlawful for any person to fail or refuse to submit information required under this part. In addition, TSCA section 15(3) makes it unlawful for any person to fail to keep, and permit access to, records required by this part. TSCA section 16 provides that any person who violates a provision of TSCA section 15 is liable to the United States for a civil penalty and may be criminally prosecuted.” See Section 705.1 of the published rule.

What is the potential for reporting changes that should drive a priority for internal tracking of substances for higher probability future reporting requirements?

Several U.S. states are proposing or considering duplication of Maine and Minnesota product-level reporting requirements. The likelihood is high that additional state-level obligations will emerge in the near future, so tracking the use of these substances is likely to serve many additional regulations beyond TSCA Section 8(a)(7).

What is the definition of an article?

The definition of “article” is fairly consistent with other chemicals management regulations. See Section 705.3, Definitions, on page 33 of 44:

“Article means a manufactured item which: (1) Is formed to a specific shape or design during manufacture; (2) Has end use function(s) depending in whole or in part upon its shape or design during end use; and (3) Has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless of shape or design.”

What is considered due diligence?

The EPA addresses “due diligence” numerous times throughout the rule. For example, on page 5 of 44: “This standard would require 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. Such activities may, though not necessarily, include phone calls or email inquiries to upstream suppliers or downstream users or employees or other agents of the manufacturer, including persons involved in the research and development, import or production, or marketing of the PFAS.”

Further down on page 6 of 44: “If, after conducting due diligence and reviewing known or reasonably ascertainable existing information, a manufacturer, particularly an importer of articles containing PFAS, may not have knowledge that they have manufactured or imported PFAS and thus need not report under this rule. EPA encourages such an entity to document its activities to provide evidence of due diligence. Additionally, consistent with their own business practices, companies may elect to retain documentation of their conclusion that they were not subject to reporting requirements.”

What if a supplier states “no PFAS,” so a company does not report, but the product is later found to contain PFAS? How is this handled?

The EPA addresses “due diligence” numerous times throughout the rule. For example, on page 6 of 44: “If, after conducting due diligence and reviewing known or reasonably ascertainable existing information, a manufacturer, particularly an importer of articles containing PFAS, may not have knowledge that they have manufactured or imported PFAS and thus need not report under this rule. EPA encourages such an entity to document its activities to provide evidence of due diligence. Additionally, consistent with their own business practices, companies may elect to retain documentation of their conclusion that they were not subject to reporting requirements.”

We did a preliminary survey of our suppliers. Most of them have no idea this regulation exists and have no data on hand at this time. What do we do?

What should we do if we have hundreds of chemicals to review? How do we know we caught everything?

This standard requires manufacturers to conduct a “reasonable inquiry,” which may also require inquiries outside the organization to fill gaps in knowledge. Such activities may include phone calls or email inquiries to upstream suppliers or downstream users.

The EPA encourages manufacturers to document their activities to provide evidence of due diligence. Additionally, companies may want to retain documentation of reasons for their conclusion that they were not subject to reporting requirements (e.g. supplier declarations that indicate “no PFAS”).

We do not import or manufacture PFAS but we use material containing PFAS in our products. How does this impact us?

You will need to complete reporting for any PFAS that you are importing, even if they are already incorporated into an “article” (such as a surface coating). If you are only using PFAS as part of domestically sourced materials, then as a downstream user, you do not have any additional reporting obligations under TSCA Section 8(a)(7). However, you may still have product-level reporting obligations in states such as Maine or Minnesota.

If rolls of textile fabrics have not yet been turned into a final product, but have PFAS coatings, would they be considered an article and require reporting?

They would be subject to reporting if imported.

We are in EU and we deliver to the U.S. What is the deadline to complete the report?

The portal for reporting your imported materials will open on November 12, 2024, and you must report by May 8, 2025. “Small manufacturers” (as defined by the regulation) will have until November 10, 2025, to finish reporting.

Is there an end date for the reporting rule? Will we need to report products that we will put on the market in the future as well?

The reporting portal will open November 12, 2024. For most manufacturers, the regulation defines May 8, 2025, as the end date. For those who meet the definition of “small manufacturer,” as defined in the regulation, the end date is November 10, 2025. This particular TSCA rule is for one-time reporting. Note that other PFAS regulations may require recurring reporting, so check each regulation

This going to be a one-time report or should we expect annual reporting afterwards?

Currently, this is one-time reporting for TSCA Section 8(a)(7). However, other jurisdictions may require annual reporting of sales of products with PFAS.

Is the PFAS list under TSCA the same as PFAS under REACH?

No. There are different requirements for PFAS under TSCA and REACH.

Our company purchased a division of a large electronics company just recently. Who is responsible for reporting data going back to 2011?

I recommend that you review the obligations for acquisitions with in-house counsel. It is likely that you will be responsible for that reporting based on other legacy obligations under laws like CERCLA; however, in-house counsel can advise on these legal obligations.

As a machine manufacturer importing machines to the U.S., would we need to report parts that are on the market (e.g., HMI, semicon products that are generically used) but not specifically in our equipment?

Article manufacturers will need to report any PFAS that they are IMPORTING, even already incorporated into articles (such as in a coating). If you are importing machinery and those machines incorporate PFAS, they will need to be reported.

Regardless of whether you are obtaining materials domestically or by importation, you may likely be in scope of registering your products containing PFAS for the state of Maine beginning January 2025.

We purchase components from distributors that are global companies. Where does we fall into scope for product origin as it ships to us in the U.S.?

You will need to report on any PFAS that are being imported, whether on their own or incorporated into articles (such as articles that incorporate PFAS into surface coatings).

Is this reporting required at a facility level or can we report at a corporate level for ALL our U.S.-based locations?

The “full reporting” form lists required reporting details under 705.15: “…persons identified in §705.10 must report to EPA, for each site of each of the chemical substances identified in §705.5, the following information to the extent known to or reasonably ascertainable by them, except as allowed under §705.18… (a) Company and plant site information. The following currently correct company and plant site information must be reported for each site at which a reportable chemical substance is manufactured (see 40 CFR 711.3 for the ‘‘site’’ for importers)…

See page 35 of 44 for the full details of this section.

What are the reporting units? Does the report require total weight or is it itemized and then summed?

The reporting units are different depending on which of the three reporting forms you’re using. Please check the details in sections 705.15 (full form) or 705.18(a) (article importers form).

So, does this applies to items that we’d use in our facilities (seals, hoses, etc.) but don’t go to market? Does facility maintenance use have to be reported?

Yes, if they were imported.

The definitions of manufacturer, article, “imported in an article” and “processed, distributed in commerce” as well as “manufacture for commercial purposes” are vague. If we import articles such as electrical components, gaskets, or polycarbonate resins that may contain PFAS as a flame retardant, are we required to report? We do not have any specific knowledge of the substance, percentage, weight, or other details.

Yes, you would have an obligation to report under this rule.

There a location or online portal that can provide some guidance or do all regulators have their own?

Unfortunately, there is no coordinated location between different regulatory agencies where they pool all of their data and guidance together. Each agency (EPA, ECHA, Maine Department of Environmental Protection, etc.) will have their own sites and reference materials. For PFAS, they may all define PFAS “of concern” differently.

Say you are able to identify that PFAS were used in an article that was produced long ago but within the reporting period. You’re able to narrow it down to a certain subset of PFAS chemicals, but you cannot identify the exact chemical or how much each article contained. Would this be reported, or would this fall under not “reasonably ascertainable”? If it is reported, would you just report the incomplete information you were able to find?

Manufacturers with partial data: If, after reasonable inquiry has been attempted, manufacturers don’t know nor can reasonably make estimates for certain data elements, they may indicate such information is “Not Known or Reasonably Ascertainable” (NKRA) to them when completing reports.

We do not import into the U.S. but our distributors do. Who has the reporting obligation?

Article manufacturers will need to report any PFAS that they are IMPORTING, even already incorporated into articles (such as in a coating). If you are only using PFAS that you are sourcing domestically, whether from the chemical manufacturers themselves or through distributors, then you would not need to report those for TSCA Section 8(a)(7). In your example, the distributor would need to report (but only for the PFAS they’re importing to the U.S.). The exception for you would be if you are processing the materials in any way that creates a by-product that is itself a PFAS.

Regardless of whether you are obtaining materials domestically or by importation, you may be in scope of registering your products containing PFAS for the state of Maine beginning January 2025.

What documentation from a supplier of product with intentionally added PFAS is sufficient support for the TSCA report?

The EPA does not require any specific reporting format for documentation to support their “due diligence” requirements. The data points you’ll need to report are dependent on the form you are using. Requirements for the full reporting form are listed in Section 705.15 (beginning on page 35 of 44 in the Federal Register publication) while the requirements for the streamlined forms for “article importers” and “R&D producers” can be found in Section 705.18 (beginning on page 40 of 44).

Please also note that the phrase “intentionally added” is not a factor in this reporting rule, nor is it used on the rule itself. The purpose of the rule is for the EPA to understand which PFAS are being used in the United States, and for what purpose. The EPA provides an answer to the comments they received suggesting that “intentionally added” be a consideration on page 19 of 44 in the Federal Register publication.

We buy PTFE 9002-84-0 rods domestically and parts made from PTFE 9002-84-0, and build them into our parts, which are then sold globally. Do we technically manufacture articles that contain PFAS?

Article manufacturers will need to report any PFAS that they are IMPORTING, even already incorporated into articles (such as in a coating). If you are only using PFAS that you are sourcing domestically, then you would not need to report those for TSCA Section 8(a)(7). The exception would be if you are processing the materials in any way that creates a by-product that is itself a PFAS

Regardless of whether you are obtaining materials domestically or by importation, you may be in scope of registering your products containing PFAS for the state of Maine beginning January 2025.

We are contract manufacturer to global customers making injection molded parts. We only use raw materials we buy from our suppliers. We may sometimes use process aids, like a mold release agent, or use a component during assembly, like lubricant grease. How does this ruling affect us? Do we need to report anything if we are not producing PFAS and are not intentionally using PFAS in manufacturing process?

If you are sourcing PFAS domestically, you will not need to report those; the manufacturer of the PFAS chemicals themselves has to report. Keep in mind, however, that if any of your processing creates by-products that are PFAS, you WOULD need to report those by-products as you’ve now “manufactured” a new PFAS.

The phrase “intentionally added” is not a factor in this reporting rule, nor is it used on the rule itself. The purpose of the rule is for the EPA to understand which PFAS are being used in the United States, and for what purpose. If you are importing the processing aids, and they contain PFAS, they will need to be reported even if they are not part of any finished products. The EPA provides an answer to the comments they received suggesting that “intentionally added” be a consideration on page 19 of 44 in the Federal Register publication

What is the end of the reporting period? Will we need to report on PFAS for 2023 and 2024?

The EPA does not provide a concrete “end year” for the reporting period. There are a few places where you might infer the end date, however. First, you may logically deduce that 2022 is the last full year required for reporting from the section about who must report:

“§705.10 Persons who must report. Persons who have manufactured for commercial purposes a chemical substance identified in § 705.5 at any period from January 1, 2011, through the end of the last calendar year prior to November 13, 2023, except as described in § 705.12, is subject to the requirements of this part.”

However, technically, this section is not about the data that must be reported.

Separately, in the section titled “G. What are the requirements for submitting CBI claims?”, EPA makes reference to the reporting rule covering 11 years (page 13 of 44): “… In light of the extended timeframe (11 years) covered by this reporting rule, it is possible that the submitter’s supplier is unknown or no longer exists…”

Using a “starting year” of 2011, this would mean the last full year of reporting would be 2021, not 2022, as one might infer from the statement about “who must report.”

It’s advised that in the absence of further clarification from the EPA (which may yet be forthcoming), you review this target date with in-house counsel. Given that state reporting obligations will be based on current data without the “look-back” of this TSCA Section 8(a)(7) reporting rule, and since most manufacturers will need to comply with state reporting as well, it would be practical and a best practice to collect data from 2011 through the present. If the EPA hasn’t already confirmed the end date by November 2024, when the portal opens up for reporting, it will likely be clarified at that time.

We are a PCB assembly shop. We use electronic components defined by customer bills of materials (BOMs) and use process materials (like solders). How does PFAS apply to us? We have no idea how to look for historical data or existing parts inventory (millions of different unique part numbers) or incoming distributor inventory.

You will likely only need to report on any PFAS that you are importing, either on its own as a “substance” or incorporated into a mixture or an article (such as in the coating of electrical components or wire). If you are sourcing PFAS domestically you will not need to report those — the manufacturer of the PFAS chemicals themselves will. Keep in mind, however, that if any of your processing creates by-products that are PFAS, you WOULD need to report those by-products, as you’ve now “manufactured” a new PFAS. I recommend that you refer to ChemSec’s guide on common uses of PFAS in electronics for more information on where some of your highest risks for PFAS may be.

Most of my suppliers do not provide concentration levels. If there is no de minimis, why is the specific concentration important? How should it be entered via Assent Portal?

This information is required in the full TSCA Section 8(a)(7) reporting form. It is also essential information for conducting reporting for state laws including January 2025 rules for the state of Maine.

We are a plastics distributor of sheet, rod, and tube and purchase our materials domestically. Do I need to supply a PFAS report to Assent if they ask for this? Also, If I do get an Assent request, how do I say it is domestic?

If you receive a request from Assent, it is because one of your customers is asking for this information. Many customers are using the Assent PFAS Identification solution not only to comply with the new TSCA Section 8(a)(7) rule, but to gather information for pending state product registration rules (e.g. Maine, Minnesota) for which “domestic” versus “imported” is not relevant. Still others are collecting information to determine their supply chain obsolescence risk or to respond to insurer questions. If you have questions about the status of a request from your customers, we recommend to discuss this with your customers directly

Our U.S.-produced products were exported and recalled. Does that need to be reported?

There is nothing in the rule that clarifies this particular situation. However, the EPA makes several references to various scenarios for “re-importing” for which reporting would still be required, so you may want to discuss with your in-house counsel. You may want to also report your re-imported products from a due diligence standpoint. Some of the EPA’s examples start on page 20 of 44 in the final rule.

“EPA also believes that applying the reporting requirements each time a PFAS is imported into the United States is consistent with TSCA’s definition of manufacturing under TSCA Section 3(9) (which means ‘‘to import into the customs territory of the United States [as defined in general note 2 of the Harmonized Tariff Schedules of the United States], produce, or manufacture’’) and the directive under TSCA section 8(a)(7).”

Manufacturers must report when the PFAS-related information is “known to or reasonably ascertainable by the manufacturer.” “Known 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.” Additionally, the rule states, “if particular information cannot be derived or reasonably estimated without conducting further customer surveys (i.e., without sending a comprehensive set of identical questions to multiple customers), it would not be ‘reasonably ascertainable’ to the submitter. Thus, there is not a need to conduct new surveys for purposes of this rule.” Does this mean we are not responsible for downstream information and would not report (example: substances contained in a subcomponent of an off-the-shelf purchased article)?

At first glance, the statement about not needing new surveys is confusing. However, it is referring to customers and how they use the products that include PFAS, not suppliers who need to share information about where PFAS are located. Suppliers are specifically called out earlier as within the scope of “reasonably ascertainable” data and due diligence. Therefore, we recommend that manufacturers conduct the supplier surveys as indicated by the EPA (this is also now allowed under the Maine reporting rule instead of their previously required testing) but consider whether they will need to send specific standalone surveys to customers to fulfill the “usage” information, especially if they already know HOW customers are using their products.

From the rule: “This standard would require 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. Such activities may, though not necessarily, include phone calls or email inquiries to upstream suppliers or downstream users…”

Further on, EPA states: “However, if particular information cannot be derived or reasonably estimated without conducting further customer surveys (i.e., without sending a comprehensive set of identical questions to multiple customers), it would not be ‘‘reasonably ascertainable’’ to the submitter. Thus, there is not a need to conduct new surveys for purposes of this rule.”

When will Assent start collecting data for customers?

Assent’s TSCA PFAS Identification solution is available now.

Cally Edgren
Vice President, Regulatory & Sustainability

Cally is a proven compliance program leader with experience developing, communicating, and executing company goals and strategies. She is a subject matter expert on product  Read More