Question 1

When does the PFAS reporting rule become effective?

Accepted Answer

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.

Question 2

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

Accepted Answer

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

Question 3

Do air conditioner gasses need to be reported?

Accepted Answer

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.”

Question 4

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

Accepted Answer

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

Question 5

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

Accepted Answer

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.

Question 6

Are fluoropolymers included?

Accepted Answer

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.”

Question 7

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

Accepted Answer

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.

Question 8

Are imports through the internet covered by the rule?

Accepted Answer

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.

Question 9

Are packaging materials in scope?

Accepted Answer

Yes.

Question 10

Are pesticide devices included in the exemption?

Accepted Answer

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.

Question 11

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

Accepted Answer

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.

Question 12

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

Accepted Answer

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.”

Question 13

Are the same substances considered PFAS in America and Europe?

Accepted Answer

The definitions are not harmonized and must be evaluated separately.

Question 14

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

Accepted Answer

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

Question 15

Can a FMD be submitted as a replacement for PFAS?

Accepted Answer

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).

Question 16

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

Accepted Answer

Yes.

Question 17

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

Accepted Answer

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.

Question 18

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?

Accepted Answer

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).

Question 19

Can your software LINK with your customers’ ERP system?

Accepted Answer

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.

Question 20

Did the OECD publish the complete list?

Accepted Answer

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).

Question 21

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

Accepted Answer

PFAS State Activity TrackerAn 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.

Question 22

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?

Accepted Answer

Yes.

Question 23

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

Accepted Answer

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.

Question 24

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?

Accepted Answer

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

Question 25

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

Accepted Answer

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

Question 26

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

Accepted Answer

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

Question 27

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

Accepted Answer

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

Question 28

Do these PFAS requirements apply to consumer goods?

Accepted Answer

“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.

Question 29

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

Accepted Answer

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.

Question 30

Do we have to report on obsolete products?

Accepted Answer

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.

Question 31

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

Accepted Answer

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

Question 32

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

Accepted Answer

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

Question 33

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 ?

Accepted Answer

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.

Question 34

Do you report through the EPA website?

Accepted Answer

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

Question 35

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

Accepted Answer

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

Question 36

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

Accepted Answer

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

Question 37

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

Accepted Answer

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.

Question 38

Does the EPA require PFAS reporting for packaging material?

Accepted Answer

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

Question 39

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

Accepted Answer

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.

Question 40

Isye packaging material within the scope of the rules?

Accepted Answer

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

Question 41

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

Accepted Answer

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.

Question 42

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

Accepted Answer

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

Question 43

Does the federal regulation apply only to intentionally added PFAS?

Accepted Answer

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.

Question 44

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

Accepted Answer

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.

Question 45

Does the reporting scope include privately held companies?

Accepted Answer

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

Question 46

Does the rule apply to discontinued products?

Accepted Answer

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

Question 47

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

Accepted Answer

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

Question 48

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

Accepted Answer

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).

Question 49

Does this apply to the casting/forging manufacturing businesses?

Accepted Answer

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

Question 50

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

Accepted Answer

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

Question 51

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.

Accepted Answer

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.

Question 52

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

Accepted Answer

Correct.

Question 53

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

Accepted Answer

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

Question 54

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?

Accepted Answer

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

Question 55

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

Accepted Answer

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

Question 56

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

Accepted Answer

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.

Question 57

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?

Accepted Answer

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.

Question 58

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

Accepted Answer

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

Question 59

Are food contact materials in scope of these requirements?

Accepted Answer

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

Question 60

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?

Accepted Answer

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

Question 61

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?

Accepted Answer

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.

Question 62

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?

Accepted Answer

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

Question 63

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?

Accepted Answer

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.”

Question 64

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

Accepted Answer

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

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Tag: PFAS

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

Unpacking the Recent Announcement on PFAS Requirements Under TSCA

Assent Media Statement TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances

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Assent Media Statement
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