EPA PFAS Announcement: 3 Impacts of the New TSCA PFAS Rule

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.

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

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.”

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

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.

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.”

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.

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.

Yes.

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.

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.

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.”

The definitions are not harmonized and must be evaluated separately.

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

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).

Yes.

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.

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).

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.

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).

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.

Yes.

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.

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

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

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

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

“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.

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.

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.

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

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

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.

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

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

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

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.

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

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.

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

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.

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

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.

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.

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

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

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

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).

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

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

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.

Correct.

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

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

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

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.

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.

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

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

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

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.

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

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.”

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

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

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

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

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.

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

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.

Solely purchasing PFAS products domestically carries no reporting obligations.

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

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

The obligation rests with Company B

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

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

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

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.

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.

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.

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

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

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.

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

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

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.

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

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

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

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.

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.

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.

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

It is likely the distributor has the reporting obligation

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

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

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

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

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.

Yes

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.

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

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

Please see here for more information on this.

Yes.

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

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

The EPA has not yet announced PFAS education or training.

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).

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

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

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

At this time, you only need to report once.

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

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

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.

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.”

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.

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.

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

Yes, if they are imported.

Only the distributor.

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

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.

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.

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.

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.

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.

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

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.

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.”

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.”

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.

“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

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.

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

“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.

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.

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).

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.”

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.”

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.”

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”).

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.

They would be subject to reporting if imported.

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.

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

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.

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

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.

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.

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).

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.

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).

Yes, if they were imported.

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

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.

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.

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.

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.

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.

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

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.

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.

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.

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

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).”

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.”

Assent’s TSCA PFAS Identification solution is available now.