Kelley Green Law https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law Chemical law, emerging contaminants, and regulatory news and insights Thu, 11 Jul 2024 06:39:46 -0400 60 hourly 1 Rhode Island Joins the Fray, Banning PFAS in Numerous Consumer Goods; Pennsylvania Readies Bill in House https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/rhode-island-joins-the-fray-banning-pfas-in-numerous-consumer-goods-pennsylvania-readies-bill-in-house https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/rhode-island-joins-the-fray-banning-pfas-in-numerous-consumer-goods-pennsylvania-readies-bill-in-house Tue, 09 Jul 2024 15:27:00 -0400 Joining the ranks of California, Maine, New York, Colorado, Minnesota, and Washington, Rhode Island has officially finalized a ban on the manufacture, sale, and distribution of numerous products (as well as Class B firefighting foam) containing per- and polyfluoroalkyl substances (“PFAS”). Pennsylvania looks ready to follow suit as a similar PFAS ban was introduced in the state General Assembly.

H7356 (a/k/a “Consumer PFAS Ban Act of 2024” or “the Act”) was introduced in the Rhode Island House in late-January earlier this year, and survived numerous amendments and committees before it was successfully approved and sent to the upper chamber in mid-June. The Rhode Island Senate passed the Act quickly, sending it to Governor Daniel McKee’s office on June 21. Governor McKee signed the Act five days later.

Effective January 1, 2027, no person will legally be able to manufacture, sell, offer for sale or distribute in Rhode Island any “covered product” that contains “intentionally added” PFAS. “Covered products” include carpets or rugs, cookware, cosmetics, fabric treatments, juvenile products, menstrual products, ski wax, and textile articles. The same goes for artificial turf and outdoor apparel for severe wet conditions, unless accompanied by a “legible, easily discernable disclosure” including the following statement: “Made with PFAS chemicals.”

The prohibition does not apply to the sale or resale of used products.

Effective January 1, 2025, the Act also prohibits a person, local government, or state agency from discharging class B firefighting foam containing intentionally added PFAS, including for training purposes. The manufacturing or sale of class B firefighting foam containing PFAS is also prohibited on the same date. The bill requires manufacturers/sellers of firefighting personal protective equipment (“PPE”) to provide written notice to the purchaser at the time of sale if the firefighting PPE contains PFAS.

The Rhode Island Department of Environmental Management is responsible for implementing and enforcing the PFAS restrictions. The bill authorizes the Department to seek civil penalties of up to $1,000 for a first violation and $5,000 for subsequent violations.

Meanwhile, in Pennsylvania, HB 2238 similarly stands to ban intentionally added PFAS in covered products effective January 1, 2027, including artificial turf, cleaning products, carpets or rugs, cookware, cosmetics, dental floss, fabric treatment, food packaging, juvenile products, menstrual products, oil and gas products, ski wax, and textile articles. A total ban on products containing PFAS would become effective January 1, 2033, except for where the introduction of PFAS is a currently unavoidable use. Similar exemptions are provided for in Maine’s PFAS ban. Moreover, if passed as drafted, the bill would also require manufacturers whose products contain intentionally added PFAS to register with the Pennsylvania Department of Environmental Protection.

While Rhode Island and Pennsylvania have given themselves a longer runway to implement these prohibitions, “first mover” states like Maine have spent the last several years struggling to implement their PFAS bans. Indeed, two years after Maine passed their initial PFAS-in-products prohibitions, the state significantly overhauled its ban in light of noteworthy implementation difficulties, in turn dramatically shrinking the scope of the reporting requirements and creating a staggered phase-out system for numerous consumer products containing intentionally added PFAS.

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Citing Implementation Costs, California PFAS-Ban Bill Dies in State Senate https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/citing-implementation-costs-california-pfas-ban-bill-dies-in-state-senate https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/citing-implementation-costs-california-pfas-ban-bill-dies-in-state-senate Mon, 17 Jun 2024 10:18:00 -0400 After facing heavy opposition since initially introduced five months ago, California state senators have decided to scrap SB 903, a highly controversial bill that would have prohibited the distribution, sale, or offering for sale of products containing ​“intentionally added” per- and polyfluoroalkyl substances (“PFAS”). The California Senate Appropriations Committee voted to abandon the bill in light of strong opposition by industry groups and concerns raised by the California Department of Toxic Substances Control (“DTSC” or “the Department”) regarding implementation. Specifically, DTSC said that implementing SB 903 would cost, at a minimum, $10 million annually. California currently faces a $45 million budge deficit.

Originally introduced by California state senator Nancy Skinner (D-Berkeley), SB 903 would have adopted prohibitions on the manufacturing, distribution, and sale of products containing intentionally added PFAS akin to bans in Maine and Minnesota. The scaling of SB 903 is a noteworthy difference though – California remains the fifth largest economy in the world since 2017.

During deliberations, DTSC told the California Senate Appropriations Committee staff that the bill would create such a large new universe of regulated entities that the Department would have to establish a new branch within the organization to “develop, implement, and administer this new initiative.” DTSC furthered that “the exact magnitude of this bill is unknown; however, the department anticipates it would require at least 44 positions and over $10 million to sufficiently implement this bill as currently written.” Moreover, “[t]o the extent that other state departments use or procure products containing intentionally added PFAS that would be affected by this bill, [there are] unknown but potentially significant state costs for state boards, departments, and organizations to comply with the provisions of this bill.”

Despite SB 903’s failure to pass through the California Legislature, the Golden State’s existing efforts to restrict the use of PFAS in consumer goods remain evident. For example, AB 1817 and AB 2771 passed through the legislature easily and were both signed by Governor Gavin Newsom on September 29, 2022. These bills respectively prohibit the manufacturing, distribution, sale, or offering for sale of textile articles or cosmetic products containing PFAS beginning January 1, 2025.

Nevertheless, California seems to have picked up on something by observing the implementation struggles that “first mover” states like Maine are dealing with. Indeed, two years after Maine passed their initial PFAS-in-products prohibitions, the state significantly overhauled its ban in light of noteworthy implementation difficulties, in turn dramatically shrinking the scope of the reporting requirements and creating a staggered phase-out system for numerous consumer products containing intentionally added PFAS.

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EPA Adds Seven More PFAS “Forever Chemicals” To Toxics Release Inventory Reporting Program https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-adds-seven-more-pfas-forever-chemicals-to-toxics-release-inventory-reporting-program https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-adds-seven-more-pfas-forever-chemicals-to-toxics-release-inventory-reporting-program Fri, 17 May 2024 15:19:00 -0400 The U.S. Environmental Protection Agency (“EPA” or “the Agency”) has finalized the addition of seven per- and polyfluoroalkyl substances (“PFAS”) to the Toxics Release Inventory (“TRI”) program, publishing the final rule in the Federal Register on May 17. With the inclusion of these chemicals, EPA now lists 196 PFAS chemicals subject to the TRI reporting requirements under Section 313 of the Emergency Planning and Community Right-to-Know Act (“EPCRA”).

The seven chemicals are:

  • Perfluorohexanoic acid (“PFHxA”); Chemical Abstracts Service Registry Number (“CASRN”) 307-24-4;
  • Perfluoropropanoic acid (“PFPrA”); CASRN 422-64-0;
  • Sodium perfluorohexanoate; CASRN 2923-26-4;
  • Ammonium perfluorohexanoate; CASRN 21615-47-4;
  • 1,1,1-Trifluoro-N-[(trifluoromethyl)sulfonyl] methanesulfonamide (“TFSI”); CASRN 82113-65-3;
  • Lithium bis[(trifluoromethyl)sulfonyl] azanide; CASRN 90076-65-6; and
  • Betaines, dimethyl(.gamma.-.omega.-perfluoro-.gamma.-hydro-C8-18-alkyl); CASRN 2816091-53-7.

As discussed at proposal earlier this year, the first six PFAS were added pursuant to the 2020 National Defense Authorization Act, which outlines how the Agency may automatically add certain PFAS to the TRI in annual phases once a toxicity value has been finalized. Because EPA finalized toxicity values for those PFAS in 2023, they are automatically added for Reporting Year 2024. The last PFAS, Betaines, dimethyl(.gamma.-.omega.-perfluoro-.gamma.-hydro-C8-18-alkyl), is being added for TRI Reporting Year 2024 after confidentiality claims were rescinded for the substance.

Reports for these chemicals will first be July 1, 2025, covering the 2024 calendar year. For the 189 PFAS previously on the TRI list reports for the 2023 reporting year are due by July 1, 2024.

Note that EPA classified PFAS as ​“chemicals of special concern” on October 23, 2023, thereby eliminating applicability of the de minimis exemption which allowed facilities to forego accounting for negligible amounts of PFAS in chemical mixtures when present at concentrations below 1% (or 0.1% for carcinogens) in the materials they process or otherwise use in their manufacturing process.

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Maine Dramatically Revamps and Delays PFAS Reporting Rules and Consumer Product Bans https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/maine-dramatically-revamps-and-delays-pfas-reporting-rules-and-consumer-product-bans https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/maine-dramatically-revamps-and-delays-pfas-reporting-rules-and-consumer-product-bans Thu, 25 Apr 2024 15:30:00 -0400 After years of tumultuous and unpredictable regulatory uncertainty, the Maine Legislature has again decided to overhaul the state’s PFAS in Products program, dramatically shrinking the scope of the reporting requirements and creating a staggered phase-out for numerous consumer products containing intentionally added per- and polyfluoroalkyl substances (“PFAS”). Specifically, the recently signed bill does away with the requirement compelling all manufacturers of products with intentionally added PFAS to report certain information to the Maine Department of the Environment (“MDEP” or “the Department”), and instead only requires manufacturers of such products to report if MDEP has determined that the product is a “currently unavoidable use” (“CUU”).

Under the previous regime with which many companies have been scrambling to comply, all manufacturers of products for sale in Maine, including online sales, that contain PFAS were required to submit to MDEP by January 1, 2025, a one-time written notification that includes a brief description of the product, the purpose for which PFAS are used in the product, and the amount of PFAS in the product, among other things, subject to limited exceptions. Now, only manufacturers whose products contain intentionally added PFAS and for which MDEP has determined that the use of PFAS in the product is a CUU must report. The amendment leaves to the Department to “by rule identify specific products or product categories” containing intentionally added PFAS for which it has determined that use of PFAS in the product is a CUU. The Department has already begun a rulemaking initiative on this matter.

Note that there are two manufacturer exemptions to this reporting rule: (1) manufacturers that employ 100 or fewer people; and (2) when MDEP has granted a waiver because the Department has already determined that “substantially equivalent information” is already publicly available. There are also multiple products that are exempt from this reporting rule, including firefighting/fire suppressing foam, medical devices and drugs regulated by the U.S. Food and Drug Administration (“FDA”), motor vehicles and motor vehicle equipment, and semiconductors, among numerous other products.

Beyond this surprising constriction of the reporting requirement, the bill will also phase out certain products containing intentionally added PFAS, prohibiting the sale, offering for sale, or distribution for sale of the following products that contain intentionally added PFAS, unless they have been granted a CUU:

January 1, 2026 – Cleaning products, cookware, cosmetics, dental floss, juvenile products, menstruation products, textile articles (excluding outdoor apparel for severe wet conditions or that is included in or a component of a watercraft, aircraft or motor vehicle), ski wax, or upholstered furniture.

January 1, 2029 - Artificial turf and outdoor apparel for wet weather (unless the apparel includes a disclosure that includes “Made with PFAS chemicals.”).

January 1, 2032 – All other products, excluding refrigeration, cooling and heating, ventilation, and air conditioning equipment.

January 1, 20240 - Refrigeration, cooling, and heating, ventilation, and air conditioning equipment.

Note that these prohibitions also apply to products that do not contain PFAS but are sold in a “fluorinated container.”

While first-movers in their field often recalibrate their approach, this bill constitutes the third time the Maine legislature has decided to amend the Pine Tree State’s PFAS in products laws. Granted, Maine is not alone in their struggle to craft cognizable rules and standards: Minnesota now stands as the state with the most aggressive PFAS reporting law, with reports due by January 2026 covering almost all PFAS-containing products sold in the state. In contrast, California Governor Gavin Newsom vetoed legislation that would have required consumer product manufacturers to submit annual reports on intentionally added PFAS in all products and product components beginning in 2026, expressing concerns about the cost and complexity of such a program. As the United States Congress considers similar legislation, it will be interesting to see how the difficulties states are experiencing in creating and implementing PFAS laws translate to the National level.

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EPA Announces Final Rule Designating Two PFAS as ​“Hazardous Substances” under CERCLA https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-announces-final-rule-designating-two-pfas-as-hazardous-substances-under-cercla https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-announces-final-rule-designating-two-pfas-as-hazardous-substances-under-cercla Thu, 25 Apr 2024 10:21:00 -0400 On April 19, 2024, the U.S. Environmental Protection Agency (“EPA” or ​“the Agency”) released details of its highly anticipated rule listing perfluorooctanoic acid (“PFOA”) and perfluorooctanesulfonic acid (“PFOS”), two forms of per- and polyfluoroalkyl substances (“PFAS”), as ​“hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA” or ​“Superfund Law”). The rule marks the first exercise of EPA’s authority to designate new ​“hazardous substances” regulated under CERCLA since the statute’s passage over 40 years ago and is expected give rise to new cleanup actions, changes in scope and/or remedy in ongoing actions, the potential of re-opening formerly closed sites, and associated litigation affecting a broad range of industries and entities that have used or received the substances in their operations.

The designation of PFOA and PFOS as CERCLA hazardous substances also is expected to trigger multiple legal challenges, as well as administrative and legislative efforts to narrow the universe of potentially responsible parties (“PRPs”) subject to potential liability in connection with the substances, and to provide protection to so-called ​“passive receivers” of them such as public water systems, publicly owned treatment works, airports, firefighting agencies, farmers who have applied biosolids to agricultural soils, among others. The rule specifically recognizes potentially affected entities, naming, among others, manufacturers of textiles, leather, petroleum, printing, plastics, rubber, glass, cement, steel, aluminum, vehicle parts, medical equipment, and home furnishings.

The rule goes into effect 60 days upon publication in the Federal Register.

CERCLA and PFAS: A Comprehensive Liability Scheme Meets a Pervasive Contaminant

The designation of two PFAS as hazardous substances is significant in part because of the nature of the chemicals involved: widely (and legally) used for decades across a broad swath of industries – from food packaging, clothing, cookware and numerous other consumer products to fire firefighting foams, machining fluids, and a host of industrial uses – with relatively minimal awareness, until recently, by users or the Agency of potential environmental or human health risks. Given the scope of usage and the prevalence of PFAS in soil and water at sites across the country, the introduction of PFAS to CERCLA’s liability scheme will no doubt expand liability for entities that previously have not been targeted in PFAS litigation.

Passed in 1980, CERCLA was designed to provide broad federal authority to respond to releases or threatened releases of ​“hazardous substances” that may endanger public health or the environment, and to broadly encompass multiple classifications of statutory ​“responsible parties” subject to liability to ensure timely cleanups and their funding. CERCLA is well known for its far-reaching retroactive, and strict liability scheme. Strict liability means that response costs may be imposed upon all parties that meet the statutory definition of a ​“responsible party,” including parties who own or operate contaminated property, caused the release or threatened release of hazardous substances, or who otherwise arranged for the disposal of hazardous substances at other sites. EPA can force PRPs to either cleanup the polluted site or reimburse the government for the full remediation of the contaminated site. Because of CERCLA’s joint and several liability scheme, any one PRP can be held liable for the full amount of the cost. Parties held liable are permitted to seek contribution costs from other PRPs. CERCLA PRPs may also be liable for Natural Resource Damages, as defined in the statute and associated regulation, and which include the often multi-million dollar efforts to assess those costs.

PFAS, an umbrella term for thousands of fluorinated chemicals, are commonly referred to as ​“forever chemicals” because of their persistence in the environment. Once PFAS are released to the environment, they resist breakdown, bioaccumulate and biomagnify through ecosystems, and permeate the environment. Since the 1950s, PFAS have been entrenched in everyday product use and manufacturing, present in aircrafts, textiles, water- or fire-resistant products, cookware, paint, bathroom products, most technology like cell phones, and many other items. PFAS are now understood by EPA and state regulatory authorities to be toxic at extremely low concentrations, with links being discovered between the chemicals and increased risks of birth defects, decreased fertility, thyroid disease and several forms of cancer, specifically testicular and kidney cancer.

Given their broad use in products and industrial processes cross many sectors of the economy, PFAS have been found in many water systems throughout the U.S., and have been detected as far as the Arctic Circle. The U.S. Centers for Disease Control reported in 2015 that 97% of Americans have PFAS in their blood and tissue, and additional, large-scale biomonitoring efforts are underway globally. The extent of the contamination is not fully known, as substantial testing only began in the last decade. Until recently, PFAS were largely unregulated, except by states that adopted their own regulations in the absence of action at the federal level.

Industry Impacts, Strict Liability, and Litigation

While environmental groups generally have praised EPA’s efforts to bring PFAS into to the CERCLA liability scheme, industry groups have expressed concern about the far-reaching consequences that potential liability across so many sectors that the listings will trigger. Accordingly, there has been significant effort to obtain liability carve-outs, particularly for downstream ​“passive receivers” of PFAS (i.e., entities that unknowingly received PFAS in material used or processed at a facility, such as municipal landfills and drinking water and wastewater treatment facilities).

EPA’s announcement about the rule was accompanied by its release of an enforcement discretion policy, in which the Agency said it will likely decline to pursue cases against community water systems, publicly owned treatment works (“POTW”), municipal separate storm sewer systems, publicly owned/operated municipal solid waste landfills, publicly owned airports, local fire departments, and farms that apply biosolids to land. Additionally, EPA announced that they will apply ​“fairness and equitable factors” to other entities in deciding whether to pursue a case.

Despite those assurances, neither CERCLA nor the rule prohibit private parties from initiating lawsuits to recover costs spent in conducting response and remediation actions against entities who EPA may decline to pursue. While the enforcement policy notes that the Agency will seek to require settling parties to waive their rights to sue parties that satisfy equitable factors, and may in fact mitigate some litigation risk concerns, the policy is not absolute and private parties may not be interested in including such a provision as part of their own settlement. Thus, even parties who do not manufacture PFAS, nor utilize them in their products, may find themselves before a court having to explain their relationship to the PFAS contamination.

On the legislative side, the Senate and House are considering bills seeking to address the expansive liability the CERCLA designation would impose on vast numbers of possible PRPs. Just two months after the ANPRM, the U.S. Senate Committee on Environment & Public Works (“EPW”) published a bipartisan draft bill that narrowed the definition of PFAS, but did not include any liability exemptions for passive receivers or other sectors.

Nevertheless, enough pressure was put on the Senate EPW Committee to convene a March 2024 hearing on the matter. Across the board, the Senators seemed interested in creating a statutory liability carve-out for those who do not use PFAS or benefit from their presence but instead encounter them in operations incidentally from upstream inputs, also known as ​“passive receivers.” There appears to be bipartisan interest in ensuring that PFAS manufacturers and polluters pay for remediation costs, but it is unclear whether any legislation will be forthcoming.

EPA’s decision markedly expands the scope of PFAS liability, both in terms of retroactivity and by creating a nearly limitless class of PRPs from whom litigants can now bring action against. For inquiries on how this rule may affect you, please contact a member of the Kelley Drye environmental team.

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PFAS Phase-out Bill Introduced in United States Congress https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/pfas-phase-out-bill-introduced-in-united-states-congress https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/pfas-phase-out-bill-introduced-in-united-states-congress Tue, 23 Apr 2024 10:57:00 -0400 Supreme Court Justice Louis Brandeis once opined that “a single courageous State may, if its citizens choose, serve as a laboratory; and try novel social and economic experiments without risk to the rest of the country.”[1] Indeed, over the last few years, numerous states like California, Maine, Minnesota, and New York have served as those laboratories when it comes to laws and regulations governing the use of per- and polyflouroalkyl substances (“PFAS”). These states have all passed legislation requiring the reporting, labeling, and for various categories of goods, the outright ban of “forever chemicals” (so-called because of their persistence in the environment) when intentionally added to consumer products. Despite these laws being criticized for vagueness and overreach (even by Democratic governors’ standards), as well as serious implementation problems plaguing the roll-out of these regulations, Congressional Democrats have introduced legislation that would phase out all “non-essential” uses of PFAS in 10 years while also amending the Comprehensive Environmental Response, Compensation & Liability Act (“CERCLA” or “Superfund”) to prevent potentially responsible parties (“PRPs”) from avoiding cleanup liability via declaring bankruptcy.

On April 18, Senate Majority Whip Dick Durbin (D-IL) and Rep. Betty McCollum (D-MN) of the House Appropriations Committee, introduced companion versions of Forever Chemical Regulation and Accountability Act (“FCRAA”) in their respective Congressional chambers. The Senate bill, S.4187, has been referred to the Environment & Public Works Committee while the House companion, H.R.8074, has been referred to five different House committees: (1) Energy and Commerce; (2) Oversight and Accountability; (3) Science, Space, and Technology; (4) Transportation and Infrastructure; and (5) Armed Services.

As written, the bill would task the National Academies of Sciences with reviewing and evaluating the available scientific evidence to determine “categories” of “essential uses” of PFAS, and provide guidance on designating PFAS uses as either “essential” or “non-essential.” Then, the bill would set a four year deadline to eliminate non-essential uses of PFAS in certain classes, and a 10-year national deadline to eliminate non-essential PFAS uses in all non-essential classes, while providing exemptions for currently unavoidable and certain critical purposes. The bill provides a petition process “to designate a use of PFAS as essential or non-essential.”

The bill also takes a page out of Maine and Minnesota’s PFAS reporting laws. Specifically, FCRAA would require all PFAS manufacturers and users to file reports with the U.S. Environmental Protection Agency (“EPA”) to disclose certain information relating to PFAS, as well as to submit their own phase-out schedule.

Beyond the phase-out and notification requirements, the bill would update CERCLA to toll state statutes of limitations and statutes of repose for newly-designated hazardous substances, like PFAS, until the later of either: the date on which it was designated as a hazardous substance; or when the plaintiff knew or reasonably should have known of their injury related to the substance. According to a section-by-section summary of the bill, FCRAA will also “prevent large corporations from exploiting bankruptcy procedures to avoid persistent, bioaccumulative, and toxic chemicals, including PFAS, claims.”

The full-text of the 107-page bill is available here. A section-by-section summary of the bill is available here.


[1] New State Ice Co. v. Lieberman, 285 U.S. 262 (1932).

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EPA Announces Drinking Water Standards for Six PFAS https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-announces-drinking-water-standards-for-six-pfas https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-announces-drinking-water-standards-for-six-pfas Tue, 16 Apr 2024 10:51:00 -0400 On April 10, 2024, the United States Environmental Protection Agency (“EPA”) announced the first enforceable federal drinking water standards under the Safe Drinking Water Act (“SDWA”) for six per- and polyfluoroalkyl substances (“PFAS”). PFAS compounds have come to be known as ​“forever chemicals” because of their ability to indefinitely persist in the environment and toxicity at extremely low levels. The final rule, which will go into effect 60 days after its imminent publication in the Federal Register, will set into motion likely legal challenges and wide-ranging consequences for drinking water providers who will need to comply with the stringent new standards, as well as for companies that may have liability for their cleanup.

Under the rule, individual enforceable limits, or Maximum Contaminant Levels (“MCLs”), for PFOA, PFOS, PFHxS, PFNA, and HFPO-DA, as well as a combined MCL for mixtures containing two or more of PFHxS, PFNA, HFPO-DA, and PFBS using a Hazard Index (“HI”) approach. In addition, the rule will establish health-based, non-enforceable Maximum Contaminant Level Goals (“MCLGs”) for these PFAS. The MCLs and MCLGs are summarized in the table below.

EPA determined that there is no level of PFOA and PFOS, which it has determined are likely carcinogens, that is without risk of adverse health effects. Therefore, the MCLs for these two contaminants are being set at 4.0 ppt, the lowest feasible level that can be detected and the most stringent in the nation. The rule also uses a risk-based standard for mixtures of PFHxS, HFPO-DA and its ammonium salt (also known as a GenX chemicals), PFNA, and PFBS. For these compounds, the rule will require the use of a formula to determine if any mixture of these chemicals in drinking water, taken together, has an ​HI score of 1.0 or greater, which indicates potential risk of adverse health effects. HI calculations account for the fact that, although certain PFAS may not be harmful at low levels, mixtures of PFAS can have additive adverse health effects.

The individual MCLs and MCLGs for PFHxS, PFNA, and HFPO-DA, are being set at 10 ppt to ensure protection of public health when only one of these PFAS is present. EPA also finalized an HI of 1.0 for any mixture containing two or more of PFHxS, PFNA, HFPO-DA, and PFBS to address health concerns related to the co-occurrence of these PFAS.

Pursuant to the final rule, public water systems that do not already monitor for PFAS will need to begin doing so. By 2027, public water systems must have completed the prescribed initial monitoring and will need to conduct ongoing compliance monitoring going forward. Systems must also include PFAS test results in consumer confidence reports and alert the public of any monitoring procedure violations beginning in 2027.

Beginning in 2029, the rule will require public water systems to be in compliance with all PFAS MCLs and to provide public notifications of any exceedances. Should exceedances occur, systems must then take action to reduce PFAS levels.

EPA also announced $1 billion in need-based funding through the Bipartisan Infrastructure Law (“BIL”) to help states and territories implement PFAS testing and treatment at public water systems and to help owners of private wells address PFAS contamination. This is included in the $9 billion that the BIL already provides to invest in communities with drinking water impacted by PFAS and other emerging contaminants, including $4 billion to the Drinking Water State Revolving Fund and $5 billion through EPA’s Emerging Contaminants in Small or Disadvantaged Communities Grant Program.

More frequent sampling and testing will impose high costs on water systems, especially those with MCL exceedances. To reduce costs for systems, EPA said that previously collected monitoring data may satisfy some or all the initial monitoring requirements if the sampling was conducted as part of the data collection program known as UCMR 5 or other appropriate monitoring campaigns.

Some industry groups and local officials are dissatisfied with EPA’s new rules, questioning the economic burden placed on water systems and manufacturers and predicting that certain manufacturing industries will seek residence in countries with less stringent environmental protections. Advocates of the rule argue that the health risks posed by PFAS are dangerous enough to warrant the cost of compliance.

The new MCLs are likely to be adopted into remedial actions performed pursuant to the federal Comprehensive Environmental Response, Compensation, and Liability Act (CERLCA), especially if EPA also finalizes its pending proposed rule to list PFOA and PFOS as hazardous substances under CERCLA. In addition, in states and/or U.S. territories that employ federal and state MCLs as a driver for remediation cleanup standards, EPA’s promulgation of the new MCLs may affect remedial activities required under state environmental remedial programs, such as state equivalents of CERCLA.

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PFAS Grease-Proofing Agents Officially Slip Out of U.S. Market https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/pfas-grease-proofing-agents-officially-slip-out-of-u-s-market https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/pfas-grease-proofing-agents-officially-slip-out-of-u-s-market Wed, 06 Mar 2024 14:04:00 -0500 Rest assured, you can stop worrying about ingesting “forever chemicals” when you use fast-food wrappers, microwave popcorn bags, and take-out paperboard containers. Last week, FDA announced here that so-called “grease-proofing” food packaging products containing PFAS will no longer be sold in the U.S. According to FDA, these types of food-contact paper products are the highest contributors of PFAS dietary exposure among all FDA authorized uses of food-contact products containing PFAS.

Other FDA-authorized categories, such as non-stick pots and pans, rubber O-rings and gaskets used in food processing equipment, and manufacturing aids added to other food contact polymers remain in place at the federal level. FDA determined that PFAS in these products would not be available to migrate at more than negligible amounts under the intended conditions of use and would, therefore, not pose a safety risk.

The recent phase-out of PFAS-containing grease-proofing food packaging was a result of a series of FDA determinations and industry action. In the early 2000s, FDA first raised safety concerns with certain PFAS substances commonly referred to as “C8 compounds” or “long-chain” compounds. This category was phased out of the U.S. market between 2011 and 2016 voluntarily and through FDA authorization revocations. In their stead, industry began to use “short-chain” PFAS replacements that had been authorized for use as grease-proofing agents.

In 2020, FDA found that a short-chain PFAS – 6:2 fluorotelomer alcohol (“6:2 FTOH”) – also may pose a safety risk. FDA found that under certain conditions, the smaller PFAS “sidechain” can detach from the polymerized molecule. As a result, there is potential for PFAS to migrate to food at levels that may result in a potential safety concern. FDA sought and obtained market-phase-out commitment letters from each of the manufacturers of PFAS grease-proofing agents that contain this substance. And in 2023, FDA received confirmation from manufacturers of all remaining authorized grease-proofing substances containing different types of PFAS (not the subject of the safety review) that those manufacturers had voluntarily stopped producing and selling these products for business reasons unrelated to safety.

FDA indicated that it will continue to test foods from the general food supply this year and next to accurately estimate U.S. consumers’ exposure to PFAS from foods. This includes testing samples from the Total Diet Study (see more on this study here) as well as a survey of bottled water. The agency will also conduct additional seafood testing. If the testing supports an FDA finding of a health concern relating to a particular food based on PFAS exposure, FDA has indicated it will take action.

As we have discussed here and here, several states have laws regulating PFAS exposure from food packaging products that are in place or moving rapidly through legislatures. Please continue to watch this space as “forever chemicals” continue to consume ever greater attention from regulators.

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California Legislation Seeks to Ban PFAS in Consumer Products Effective 2030 https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/california-legislation-seeks-to-ban-pfas-in-consumer-products-effective-2030 https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/california-legislation-seeks-to-ban-pfas-in-consumer-products-effective-2030 Tue, 27 Feb 2024 13:55:00 -0500 California’s extensive regulatory approach to per- and polyfluoroalkyl substances (“PFAS”) is poised to take a dramatic step forward with a proposed ban on the “forever chemicals” in most consumer products. Following the adoption of similar bans in Maine and Minnesota, California state senator Nancy Skinner (D-Berkeley) introduced bill SB 903 to the state senate last Monday, which would prohibit the distribution, sale, or offering for sale of products containing “intentionally added” PFAS. While the bill does not introduce anything particularly innovative by way of PFAS bans in consumer goods, it does represent one of the most comprehensive instructions to a regulatory agency on how to effectuate such a ban.

The “Ending Forever Chemicals Act” (SB 903) builds on the Golden State’s existing efforts to restrict the use of PFAS in consumer goods. For example, AB 1817 and AB 2771 passed through the legislature easily and were both signed by Governor Gavin Newsom on September 29, 2022. These bills respectively prohibit the manufacturing, distribution, sale, or offering for sale of textile articles or cosmetic products containing PFAS beginning January 1, 2025.

SB 903 proposes to apply this prohibition to all “products,” which the bill defines as “an item manufactured, assembled, packaged, or otherwise prepared for sale in California, including, but not limited to, its components, sold or distributed for personal, residential, commercial, or industrial use, including for use in making other products.” It further defines “component” as “an identifiable ingredient, part, or piece of a product, regardless of whether the manufacturer of the product is the manufacturer of the component.” The prohibition would be effective January 1, 2030. Interestingly, the bill gives the California Department of Toxic Substances Control (“DTSC”) the authority to, via rulemaking, prohibit intentionally added PFAS in a product or product category before the 2030 effective date.

Like Maine and Minnesota’s ban of PFAS in consumer goods, California also creates exemptions for products where DTSC finds via rulemaking that the presence of PFAS in the consumer good constitutes a “currently unavoidable use” (“CUU”). To qualify, the bill authorizes DTSC to solicit petitions for individual products and product categories that may qualify for a CUU waiver. The Maine Department of Environmental Protection is accepting individual CUU proposals until this Friday, March 1, for products that may fit within the standard. Meanwhile, the comment period for the Minnesota Pollution Control Agency’s proposed definition of CUU also closes on March 1.

California’s bill would statutorily codify the requirements to satisfy a CUU at HSC, Division 104, Part 3, Chapter 18, 109030.2(a). A CUU would be found where:

  1. There are no safer alternatives to PFAS that are reasonably available.
  2. The function provided by PFAS in the product is necessary for the product to work.
  3. The use of PFAS in the product is critical for health, safety, or the functioning of society.

Note that the third criterion here is borrowed from the definition of “CUU” under Maine’s prohibition exemption at 38 M.R.S. § 1614.1.B.

SB 903 further outlines what CUU petitions must contain, and how DTSC must evaluate such petitions. This includes a requirement that all petitions be subject to public comment.

Moreover, the bill provides that CUU petitions expire five years after issuance. The bill authorizes DTSC to revoke petitions prior to expiration if it can determine that the information used to justify the issuance is no longer relevant. And, importantly, the bill requires manufacturers to renew determination petitions no later than six months prior to their expiration. DTSC must also publish an online list on their website of each determination of a CUU, its expiration date, and the products and uses exempt from the prohibition.

If DTSC has reason to believe that a product contains intentionally added PFAS in violation of the bill, SB 903 authorizes DTSC to require the manufacturer to test the product and send DTSC results demonstrating compliance. Violators would be subject to a civil penalty not to exceed $1,000 per day for each violation, with repeat violations raising that penalty to a $2,500 maximum. The bill also authorizes the judiciary to enjoin sale of violating products.

While California is not the first state to issue such a ban, and has indeed borrowed almost all of these provisions from Maine or Minnesota, SB 903 represents the most realized version of such a prohibition introduced to date. It provides robust language and demarcated instructions to DTSC on how to effectuate the ban and its numerous exemptions. It also allows public comment for individual CUU petitions and explains how the CUU exemption must be renewed over time.

The bill will likely gain support in the California legislature. The real question moving forward is whether Gov. Newsom, who has vetoed several PFAS prohibition bills (see here and here) in the past for vagueness and overreach surrounding applicability and enforcement, will be satisfied with the legislation.

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EPA Rings in 2024 with Addition of Seven PFAS to Toxic Release Inventory https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-rings-in-2024-with-addition-of-seven-pfas-to-toxic-release-inventory https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-rings-in-2024-with-addition-of-seven-pfas-to-toxic-release-inventory Wed, 10 Jan 2024 13:51:00 -0500 The new year marks the final one of U.S. EPA's Per- and Polyfluoroalkyl Substances (“PFAS”) Strategic Roadmap, and so it is only fitting that the Agency begins 2024 by adding seven additional PFAS to the Toxic Release Inventory (“TRI”).

These PFAS are being added to the TRI pursuant to Section 7321 of the National Defense Authorization Act for Fiscal Year 2020 (“NDAA”), which outlines how the Agency may automatically add certain PFAS to the TRI in annual phases. The NDAA includes a provision that automatically adds individual PFAS to the TRI upon EPA’s finalization of a toxicity value. Because EPA finalized toxicity values for the following six PFAS in 2023, they are now automatically added for Reporting Year 2024:• Ammonium perfluorohexanoate; Chemical Abstract Service Registration Number (“CASRN”) 21615-47-4;• Lithium bis[(trifluoromethyl)sulfonyl] azanide; CASRN 90076-65-6;• Perfluorohexanoic acid (PFHxA); CASRN 307-24-4;• Perfluoropropanoic acid (PFPrA); CASRN 422-64-0;• Sodium perfluorohexanoate; CASRN 2923-26-4; and• 1,1,1-Trifluoro-N-[(trifluoromethyl)sulfonyl] methanesulfonamide; CASRN 82113-65-3.Ammonium perfluorohexanoate; Chemical Abstract Service Registration Number (“CASRN”) 21615-47-4;

A seventh PFAS – Betaines, dimethyl(.gamma.-.omega.-perfluoro-.gamma.-hydro-C8-18-alkyl); CASRN 2816091-53-7 – also is being added for TRI Reporting Year 2024 after confidentiality claims were rescinded for the substance.

With the addition of these seven PFAS to the TRI, 196 PFAS chemicals are now subject to the TRI reporting requirements outlined in Section 313 of the Emergency Planning and Community Right-to-Know Act (“EPCRA”). Facilities that manufacture, process or otherwise use any of these chemicals above the 100 pound annual threshold must report releases and other waste management activities involving these substances for the 2024 reporting year (reports are due July 1, 2025). Hence, facilities should be tracking the use of these chemicals now. For the other, already listed 189 PFAS subject to TRI Reporting Year 2023, reporting is due on July 1, 2024.

Note that EPA classified PFAS as “chemicals of special concern” on October 23, 2023, thereby eliminating applicability of the de minimis exemption which allowed facilities to forego accounting for negligible amounts of PFAS in chemical mixtures when present at concentrations below 1% (or 0.1% for carcinogens) in the materials they process or otherwise use in their manufacturing process.

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EPA Requires TRI Reporting of Small Concentrations of PFAS; Expands Supplier Notification for Lead and Other Chemicals of Concern https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-requires-tri-reporting-of-small-concentrations-of-pfas-expands-supplier-notification-for-lead-and-other-chemicals-of-concern https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-requires-tri-reporting-of-small-concentrations-of-pfas-expands-supplier-notification-for-lead-and-other-chemicals-of-concern Mon, 23 Oct 2023 00:00:00 -0400 Earlier today, the U.S. Environmental Protection Agency (“EPA”) finalized elimination of the de minimis exemption for reporting of per- and polyfluoroalkyl substances (“PFAS”) under the Toxic Release Inventory (“TRI”). EPA is officially designating PFAS as Chemicals of Special Concern, for which the de minimis exemption is not applicable and, therefore, tracking and reporting of small concentrations in mixtures and products used at facilities is required.

The de minimis exemption allows facilities to ignore negligible amounts of substances in chemical mixtures when present at concentrations below 1% (or 0.1% for carcinogens) in the materials they process or otherwise use in their manufacturing process. While PFAS are widely present in numerous products and chemical mixtures due to their heat-, water- and stain-resistant qualities, typically they are present at very low concentrations. As a result, as we have discussed previously, only a relatively small number of TRI reports for PFAS have been filed with the agency in recent years. Indeed, out of the 75,890 total entries reported to TRI for all chemicals in 2021 (from approximately 21,000 facilities), EPA received a mere 92 PFAS reporting forms on 46 different PFAS from 45 facilities. In contrast, there are approximately 650 PFAS are currently in commerce from about 120,000 facilities that involve merely the handling and/or potential release of PFAS.

The final rule also makes the de minimis exemption unavailable for purposes of supplier notification requirements to downstream facilities for all Chemicals of Special Concern, which in addition to PFAS includes a number of persistent, bioaccumulative and toxic (“PBT”) chemicals such as lead, mercury, and dioxins. EPA contends that the change will help “ensure that purchasers of mixtures and trade name products containing these chemicals are informed of their presence in mixtures and products they purchase.” Critics contend however, that this change – particularly for lead, which is naturally occurring and widely present in the environment and raw materials – will dramatically expand the universe of materials for which downstream facilities must track the usage, disposal, and lead content, adding millions of hours to the already labor-intensive reporting burden.

When EPA proposed to eliminate the de minimis exemption, the Agency received mixed feedback. EPA and several environmental organizations argue that the exemption is a “reporting loophole” allowing facilities to avoid reporting listed chemicals, thereby diminishing public trust, reducing transparency, and keeping community members in the dark about chemicals they believe to be hazardous to human health. Industry stakeholders, on the other hand, contend that the de minimis exemption makes the TRI program dramatically more workable by limiting the scope of substances for which reporting is required. Moreover, the exemption is pragmatic and tries to avoid forcing companies to hunt for information on miniscule amounts of substances present in trace quantities that ultimately pose little to no risk.

Interestingly, EPA’s decision to scale back the exemption to the TRI reporting requirement, and thus open the PFAS reporting floodgates, coincides with the Agency’s issuance of a final Toxic Substances Control Act (“TSCA”) rule that similarly requires companies to electronically disclose to EPA information on PFAS uses, production volumes, disposal, exposures, and hazards, dating all the way back to 2011. Together, these two rules will dramatically expand the amount of regulatory reporting industry will conduct related to PFAS.

The new TRI requirements apply starting with the 2024 reporting year (reports due July 1, 2025). A copy of the final rule is available here: Changes to Reporting Requirements for Per- and Polyfluoroalkyl Substances and to Supplier Notifications for Chemicals of Special Concern; Community Right-to-Know Toxic Chemical Release Reporting.”

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Everything Everywhere All at Once: EPA Reporting Rule Presents Major Challenges for Companies with PFAS-Containing Products https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/everything-everywhere-all-at-once-epa-reporting-rule-presents-major-challenges-for-companies-with-pfas-containing-products https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/everything-everywhere-all-at-once-epa-reporting-rule-presents-major-challenges-for-companies-with-pfas-containing-products Thu, 19 Oct 2023 12:39:00 -0400 So-called “forever chemicals,” per- and polyfluoroalkyl substances (“PFAS”) were barely on the regulatory radar screen a decade ago. Now, much like the most recent Best Picture award winner, PFAS are seemingly “Everything Everywhere All at Once.” That is a fairly good, if perhaps slightly exaggerated, summation of the new widely anticipated PFAS reporting rule published last week by the U.S. Environmental Protection Agency (“EPA”).

The scope of potentially affected companies and products is immense: The reporting obligation extends not only to companies that manufacture or import PFAS chemicals but also to the much wider array of companies that have imported PFAS-containing “articles” in any year since January 1, 2011. A large number of companies will be required to file reports for many consumer products they import for sale that historically often contained PFAS for their heat-, stain-, and water-resistance, non-stick, and other qualities. The scope of potential products in which PFAS have been used is vast and varied, including food packaging, carpets and upholstery, water-resistant clothing and footwear, cookware, cleaning products, dental floss, cosmetics, and paints, among many others.

[The rule] will provide EPA, its partners, and the public with the largest-ever dataset of per- and polyfluoroalkyl substances (PFAS) manufactured and used in the United States.

- EPA Press Release

Companies that have imported such products (“articles”) into the United States now will be required to electronically report information to EPA regarding PFAS uses, production volumes, disposal, exposures, and hazards.

EPA’s definition of covered PFAS is very broad – and confusing: EPA has identified at least 1,462 PFAS that may be covered by the reporting rule. This broad coverage is due to the agency’s decision to define PFAS by chemical structure, rather than issuing a discrete list of chemical names and CAS numbers. For the reporting rule, PFAS include chemicals that have at least one of these three structures:

  • R-(CF2)-CF(R′)R″, where both the CF2 and CF moieties are saturated carbons;
  • R–CF2OCF2-R′, where R and R′ can either be F, O, or saturated carbons; and
  • CF3C(CF3)R′R″, where R′ and R″ can either be F or saturated carbons

I am a lawyer and not going to pretend to know whether a given chemical qualifies without first consulting a chemical expert. Needless to say this poses a significant challenge to businesses, even those that are accustomed to tracking the inventory of chemicals in their products by name and CAS number.

How do you know if you have to report? Section 8 of the Toxic Substances Control Act (“TSCA”) requires businesses to report information that is “known to or reasonably ascertainable by” them – that is, “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.” This is the same standard as under EPA’s Chemical Data Reporting (“CDR”) and other Section 8 rules.

In short, EPA emphasizes that meeting the standard requires a careful exercise of “due diligence” and that the extent of expected information-gathering activities will “vary from case-to-case.” EPA expects that, at minimum, companies will “conduct a reasonable inquiry within the full scope of their organization (not just the information known to managerial or supervisory employees).” In practice, this means that you must consult with sales and marketing personnel, researchers and scientists, as well as any others in your organization that are likely to have information on a given product and/or its chemical composition. For example, companies will be expected to have inquired about and reviewed information in marketing studies, sales reports, or customer surveys, as well as information contained in standard references, such as a Safety Data Sheet (“SDS”) or a supplier notification, and knowledge gained through conferences and technical publications.

Moreover, EPA anticipates that inquiries outside of the company may be needed to fill gaps in their knowledge. This may include contacting 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-containing product.

EPA specifies that no new customer surveys would be needed to meet the reporting standard. Generally, no new data need to be generated to satisfy the reporting inquiry, which is to be based only on existing information and knowledge that the company would be expected to know about the product. This applies to whether a product contains a PFAS chemical, as well as the other information requested by the agency on uses, exposures, hazards, and production volume.

Here is where I can tell you as a lawyer that it is imperative that you document your information-gathering efforts and responses you receive both from outside and within your organization – even (and perhaps especially) for companies that ultimately determine that reporting is not required or that particular information requested by EPA is not available.

By when must reports be submitted? The final rule takes effect on November 10, 2023, and establishes a “one-year information collection period” for companies to gather their PFAS data since 2011. After this year, companies have a six-month window to submit the information (by May 10, 2025), though “small businesses” that are only subject to the rule because they import PFAS-containing articles have an additional six months to comply (by November 10, 2025).

While 2025 may seem like a long way off, given the extent of the required data collection effort, companies will need every bit of the time provided to conduct and document their due diligence.

Ultimately, countless businesses that previously have never had to file a TSCA report are now facing a complicated data collection and reporting effort. Indeed, the reporting requirements implicate not only companies in the chemical manufacturing industry, but innumerable other consumer product sectors. Though the reporting does not capture domestically produced articles, all product manufacturers should be aware of any PFAS ingredients imported or generated incidentally in the production process.

More information can be found at EPA’s TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances website here. The Federal Register entry for the final rule can be found here.

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CPSC Collecting Data on PFAS in Consumer Products https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/cpsc-collecting-data-on-pfas-in-consumer-products https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/cpsc-collecting-data-on-pfas-in-consumer-products Thu, 21 Sep 2023 14:32:00 -0400 The Consumer Product Safety Commission (CPSC) is initiating a wide-ranging data collection effort on the use and presence of per- and polyfluoroalkyl substances (PFAS) in consumer products. As detailed in a September 30 Federal Register Notice and Request for Information (“ROI”), CPSC is requesting public comments by November 30, 2023. The information could provide the basis for a future rulemaking that may restrict or ban PFAS in a broad swath of consumer products.

CPSC is looking for information not only on uses and the presence of PFAS, but also potential exposure and toxicological effects.

Use or Potential Uses of PFAS in Consumer Products

  • Definition of PFAS “including which chemical substances should be considered a [PFAS], which chemical substances should be excluded from consideration as a PFAS, and which PFAS are considered in commerce.” This is a critical element of the scope of any CPSC action and has been the subject of debate as states generally have taken a broad view of covered PFAS in their own product-specific regulations, notably including short- and long-chain PFAS. This approach captures thousands of PFAS formulations. While only a relatively small number of PFAS have been the subject of toxicological assessments, the precautionary approach assumes that all or most PFAS share common toxicological characteristics;
  • PFAS potentially used or present in consumer products or product categories;
  • Specific PFAS and products to prioritize for assessment; and
  • Products or materials that may be sources of PFAS, including for “intentional uses” (chemical identity and physical form, functional purpose, and measurements or estimates of levels and concentrations) and incidental occurrence (sources of contaminants, chemical identity and physical form, degradation of substances or materials in products to PFAS, and measurements or estimates of levels/concentration).

Potential Human Exposures to PFAS Associated with Consumer Products Use

  • Emissions data from indoor use of PFAS-containing products;
  • Migration of PFAS from products into saliva, gastrointestinal fluid, or skin;
  • Exposure and risk data, including contact exposures from direct use of consumer products and mediated exposures such as through emission of PFAS from products to surfaces, indoor dust, or indoor air;
  • Data related to specific exposure pathways from consumer product sources;
  • Data measurements, or estimates on PFAS intake, uptake, clearance, half-life, or occurrence in people;
  • Data on the relative source contribution of consumer product(s) or ingestion of indoor dust, or inhalation of indoor air compared with other relevant sources such as drinking water or food associated with estimates of aggregate exposures; and
  • “Highly exposed” populations that may use certain consumer products “for a greater than average magnitude, frequency, or duration based on habits, practices, and characteristics specific to that population group.”

Potential Adverse Human Health Effects

  • Reports and data on whether individual PFAS, subclasses, or categories of PFAS have potential for adverse human health effects; and
  • Any information on additional sources of data and other information that CPSC should consider not already included in the Docket, available here.

Consumer product manufacturers or retailers should monitor CPSC’s efforts and consider filing comments by the November 30 deadline to help shape a future rule making. In our experience, it is usually best to engage with a regulator early in the process rather than be forced to react later after the agency forms a policy position or proposal. Data can be submitted confidentially - or potentially through an association of companies - to minimize potential adverse public perception.

Given the prominence of PFAS on the regulatory agenda for numerous federal and state agencies, and the high level of media attention being paid to the issue, it is not surprising that CPSC is initiating action.

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Maine Seeks Feedback on Types of Food Packaging Subject to PFAS Prohibition and Availability of “Safer Alternatives” https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/maine-seeks-feedback-on-types-of-food-packaging-subject-to-pfas-prohibition-and-availability-of-safer-alternatives-comments-requested-by-monday-august-21 https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/maine-seeks-feedback-on-types-of-food-packaging-subject-to-pfas-prohibition-and-availability-of-safer-alternatives-comments-requested-by-monday-august-21 Wed, 16 Aug 2023 00:00:00 -0400 After years of back-and-forth, the Maine Department of the Environment (“MDEP”) is seeking comment (by this coming Monday) on a “concept draft” regulation identifying the types of food packaging that would fall under a 2019 state ban on intentionally added per- and polyfluoroalkyl substances (“PFAS”).

Maine’s 2019 Toxic Chemicals in Food Packaging Act, codified at MRS Title 32, Section 1733 (3-B), authorizes MDEP to prohibit a manufacturer, supplier or distributor from offering for sale “a food package to which PFAS have been intentionally introduced in any amount greater than an incidental presence.” Prior to imposing such a prohibition, MDEP must issue a determination that a “safer alternative” to the use of PFAS is available. “Safer alternatives” must be readily available in sufficient quantity and at a comparable cost, and perform as well or better than PFAS in the specific food packaging application.

Relying on two assessments by Washington State’s Department of Ecology (the first in May 2021 and the second in May 2022), MDEP concludes that “safer alternatives” to the use of PFAS are available for the nine food packaging applications it received.

Specifically, the prohibition would apply to food packaging:

• Intended for direct food contact (short-term storage or to hold freshly prepared food);

• Comprised in substantial part of paper, paperboard or other materials “originally derived from plant fibers which are intended for short-term storage or to hold freshly prepared food”;

• To which PFAS have been intentionally introduced in any amount greater than an incidental presence; and

• In one of the following categories:

  1. Bags and sleeves: containers made from flexible material that can be folded flat and are typically used to transport food from a foodservice establishment. Sleeves include sealed-end bags referred to as pinch-bottom bags.
  2. Bowls: an open-topped container with a wide rim opening and a bottom that allows spooning of food. These containers are typically designed to hold foods for serving that have a substantial liquid component; this includes portion cups.
  3. Closed containers: a container that encloses food on all sides, with interlocking pieces or overlapping walls which hold the container closed for transport. Examples include clamshells, food pails, bakery boxes, and deli containers.
  4. Flat serviceware: shallow, flat-bottomed containers with large surface areas used for serving and transporting food which have one large surface or multiple compartments to separate food items during food service. Examples include, but are not limited to, trays, cafeteria-style trays, and plates.
  5. Food boats: a type of tray with tall, lipped edges and no compartments. Examples include, but are not limited to, food service containers for fried clams and lobster rolls. (Very Maine)
  6. Open-top containers: containers that enclose food on all but one side and are designed to hold food for serving or transportation. Examples include, but are not limited to, paper cones, cups, bowls, and food boats.
  7. Pizza boxes: a folded box used for serving, holding, or transporting various sizes of pizza or calzones.
  8. Plates: flat serviceware, whether single or with multiple compartments, used for serving or holding food items during food service.
  9. Wraps and liners: sheets used to wrap food for food service or create a lining inside other serviceware to act as an additional barrier.

The regulation would exempt manufacturers that have less than $1,000,000,000 of total annual national sales of food and beverage products.

MDEP is accepting public comment through August 21, 2023 on the draft and anticipates formally proposing the regulation later this year.

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Washington State Adopts Restrictions and Reporting Requirements for PFAS, Flame Retardants, Phthalates and Bisphenols in Wide Range of Consumer Products https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/washington-state-adopts-restrictions-and-reporting-requirements-for-pfas-flame-retardants-phthalates-and-bisphenols-in-wide-range-of-consumer-products https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/washington-state-adopts-restrictions-and-reporting-requirements-for-pfas-flame-retardants-phthalates-and-bisphenols-in-wide-range-of-consumer-products Thu, 29 Jun 2023 07:05:00 -0400 Joining the ranks of California, Minnesota, Maine, and New York, Washington state has officially finalized a ban on the manufacture, sale, and distribution of a variety of products containing per- and polyfluoroalkyl substances (“PFAS”), as well as several other “high profile” chemicals of concern, including flame retardants, phthalates, and bisphenols.

The rule was published by Washington’s Department of Ecology (“WDE”) on May 31, pursuant to the state’s Safer Products for Washington (“SPW”) chemical safety law that passed in 2019. The SPW charged WDE with identifying priority chemicals and making regulatory determinations to limit their uses in various categories of consumer products. Priority chemicals WDE determined to lack alternatives for their respective consumer products are instead subject to reporting requirements. The draft rule was originally promulgated in December of last year.

Specifically, the rule prohibits manufacture, sale, and distribution of the following products with intentionally added PFAS:

  • Aftermarket stain- and water-resistance treatments
    • Effective January 1, 2025
  • Carpets and rugs
    • Effective January 1, 2025
  • Leather and textile furniture and furnishings intended for indoor use
    • Effective January 1, 2026
  • Leather and textile furniture and furnishings intended for outdoor use
    • Because WDE determined that there are no chemical alternatives for these consumer goods, they shall instead be subject only to the reporting requirement.
    • Notification will be due to WDE by January 31, 2025


Interestingly, the regulation includes a novel provision that “presumes the detection of total fluorine indicates the intentional addition of PFAS.” This presumption is rebuttable upon a showing that PFAS were not intentionally added to the product. Notably, fluorine may be detected in some products due to residual or trace contaminant levels of PFAS that are thought to be widespread in the water supply, soil, and in recycled plastics and other materials.

Outside of PFAS, the regulation similarly prohibits the manufacture, sale and distribution of other specified consumer products with non-PFAS priority chemicals. Those priority chemicals and specified products are:

  • Ortho-phthalates
    • Fragrances in beauty products and personal care products
      • Effective January 1, 2025
    • Vinyl flooring
      • Effective January 1, 2025
  • Organohalogen flame retardants
    • Electric and electronic products with plastic external enclosures, intended for indoor use
      • Effective January 1, 2027 or 2028, depending on the product.
    • Electric and electronic products with plastic external enclosures, intended for outdoor use
      • Because WDE determined that there are no chemical alternatives for these consumer goods, they shall instead be subject only to the reporting requirement.
      • Notification will be due to WDE by January 31, 2025
  • Flame retardants
    • Covered wall padding made from polyurethane foam
      • Because WDE determined that there are no chemical alternatives for these consumer goods, they shall instead be subject only to the reporting requirement.
      • Notification will be due to WDE by January 31, 2025
    • Other recreational products made from polyurethane foam
      • Effective January 1, 2025
  • Alkylphenol ethoxylates
    • Laundry detergent
      • Effective January 1, 2025
  • Bisphenols
    • Drink cans
      • Effective January 1, 2025
    • Food cans
      • Because WDE determined that there are no chemical alternatives for these consumer goods, they shall instead be subject only to the reporting requirement.
      • Notification will be due to WDE by January 31, 2025
    • Thermal paper
      • Effective January 1, 2026


Where prohibitions are not feasible because of a lack of alternatives, reporting is required. The reporting notification for each priority consumer product is due one year from the effective date. They must include the CAS RN of the priority chemical that is intentionally added, the product category or categories that contain the priority chemical, the product component within the product category that contains the priority chemical, a description of the function of the priority chemical, and the concentration range of each intentionally added priority chemical in each product component in each product category.

The new regulations allow manufacturers, sellers and distributors to apply for exemptions to all of the abovementioned prohibitions, and WDE will evaluate exemptions on a case-by-case basis. In considering exemptions, WDE considers the priority chemical’s functional necessity, feasibility of legal compliance, potential alternatives (or the lack thereof), and unforeseen events and circumstances limiting the availability of alternatives.

First-time violators could be subject to civil penalties upwards of $5,000 per violation. Repeat violators are subject to penalties up to $10,000 per violation.

Interestingly, the rule includes language that seeks to avoid future federal preemption of Washington’s new ban and reporting requirements. In particular, the legislation anticipates possible regulation both by the U.S. Environmental Protection Agency (“EPA”) under the Toxic Substances Control Act (“TSCA”) and the Consumer Product Safety Commission (“CPSC”) under the Consumer Product Safety Act (“CPSA”) and/or the Federal Hazardous Substances Act (“FHSA”). TSCA authorizes the EPA to block state-level chemical rules by either issuing federal regulations for the same uses or through a finding establishing the relevant uses of the chemical present no “unreasonable risk” and thus do not require restriction.

It appears WDE sought to sidestep preemption by including provisions in the final rule that transition the program’s outright bans into preemption-immunized reporting requirements should the federal government regulate under TSCA. The final rule extends this language to specified CPSC and FHSA authorities as well.

Though WDE is certainly innovative in their preemption theory, their prohibition and reporting language mirrors the regulatory language employed by other states, including California, New York and Colorado. This language, combined with recent draft legislative language from the Northeast Waste Management Officials’ Association, seem to demonstrate that states are increasingly interested in collaborating with their neighbors to create a consistent, unified regulatory landscape that broadly governs PFAS and other chemicals.

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Maine Delays PFAS Reporting Requirement For Two Years https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/maine-delays-pfas-reporting-requirement-for-two-years https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/maine-delays-pfas-reporting-requirement-for-two-years Tue, 27 Jun 2023 18:48:13 -0400 In the midst of already tumultuous regulatory change, Maine’s Department of Environmental Protection (“MDEP”) has officially delayed the reporting requirements of their landmark per- and polyfluoroalkyl substances (“PFAS”) regulation for two years. The delay was promulgated pursuant to legislation passed by the Maine legislature that not only stalls the reporting rule but similarly creates new reporting exemptions. The bill was the only one of five proposed amendments that passed both chambers and received a signature from Governor Janet Mills.

The bill delays the reporting requirement’s effectiveness two years from January 1, 2023 to January 1, 2025. The bill also outlines specific reporting requirements that must now be included in manufacturers’ reports, including “an estimate of the total number of units of the product sold annually in the State or nationally.” Interestingly, the bill also creates two reporting exemptions: one for manufacturers that employ 25 or fewer people, and another for a “used product or used product component.”

Maine’s PFAS law still effectively bans PFAS in almost all products in the state by 2030. Specifically, the law mandates that on January 1, 2030, “a person may not sell, offer for sale or distribute for sale” products where PFAS have been “intentionally added,” except in cases of “unavoidable use.” The law also still requires companies doing business in the state to begin reporting on the presence of PFAS in their products, providing they are not exempt.

In February, MDEP promulgated a proposed rule to provide additional guidance on the reporting requirements and the definition of the magic words “intentionally added” and “unavoidable use,” which govern the scope of the legislation and 2030 ban. MDEP proposed to define “intentionally added” to include PFAS that “provide a specific characteristic, appearance, or quality or to perform a specific function,” as well as “any degradation byproducts of PFAS serving a functional purpose or technical effect within the product or its components.” “Intentionally added” would not include PFAS present in the final product as a contaminant.

The proposal also would restrict “currently unavoidable uses” to PFAS applications “that the Department has determined by rulemaking to be essential for health, safety or the functioning of society and for which alternatives are not reasonably available.” In short, the “unavoidable use” concept would not be up to the product manufacturer to determine but would require future MDEP rulemakings to dole out exemptions.

MDEP has also announced that the Maine Legislature’s Joint Standing Committee on Environment and Natural Resources “is planning to hold public meetings later this year to discuss additional issues, with the possibility of reporting out another bill with further changes in 2024.”

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With TRI Reports due July 1, EPA Expands List of Reportable PFAS https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/with-tri-reports-due-july-1-epa-expands-list-of-reportable-pfas https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/with-tri-reports-due-july-1-epa-expands-list-of-reportable-pfas Sat, 24 Jun 2023 16:28:30 -0400 With the annual July 1 deadline for filing Toxic Release Inventory (“TRI”) reports right around the corner, on June 22nd, the U.S. Environmental Protection Agency (“EPA”) finalized the addition of nine more per- and polyfluoroalkyl substances (“PFAS”) to the list of chemical subject to the reporting program (starting with reports due next year - July 1, 2024 - for the 2023 reporting year).

The rule, originally proposed in January 2023, is part of a larger effort by the Biden Administration to effectuate their PFAS Strategic Roadmap and regulate the chemicals. EPA last updated the list of PFAS subject to the TRI reporting program in July 2022.

The additional nine PFAS were added pursuant to the Fiscal Year 2020 National Defense Authorization Act (“NDAA”), which sets forth several mechanisms by which additional PFAS can be added to the list of reportable chemicals. Pursuant to the NDAA, EPA must review confidential business information (“CBI”) claims before adding PFAS to the TRI list if the chemical is subject to a claim of protection from disclosure. After review, EPA determined that the following four PFAS are no longer confidential and thus added them to the TRI:

  • Alcohols, C8-16, γ-ω-perfluoro, reaction products with 1,6-diisocyanatohexane, glycidol and stearyl alc. (2728655-42-1);
  • Acetamide, N-[3-(dimethylamino)propyl]-, 2-[(γ-ω-perfluoro-C4-20-alkyl)thio] derivs. (2738952-61-7);
  • Acetic acid, 2-[(γ-ω-perfluoro-C4-20-alkyl)thio] derivs., 2-hydroxypropyl esters (2744262-09-5); and
  • Acetamide, N-(2-aminoethyl)-, 2-[(γ-ω-perfluoro-C4-20-alkyl)thio] derivs., polymers with N1,N1-dimethyl-1,3-propanediamine, epichlorohydrin and ethylenediamine, oxidized (2742694-36-4).


Additionally, the NDAA automatically adds PFAS to the TRI upon the Agency’s finalization of a toxicity value. EPA finalized toxicity values for the following chemicals in December 2022, thus adding them to the TRI:

  • PFBA (375-22-4);
  • Perfluorobutanoate (45048-62-2);
  • Ammonium perfluorobutanoate (10495-86-0);
  • Potassium perfluorobutanoate (2966-54-3); and
  • Sodium perfluorobutanoate (2218-54-4)


Now, a total of 189 PFAS chemicals are subject to TRI reporting requirements. The addition of these nine PFAS is effective on January 1, 2023. Accordingly, facilities that manufacture, process or otherwise use any of these chemicals from that date forward must report releases and other waste management activities involving the substances for the 2023 reporting year (reports are due July 1, 2024). Hence, facilities should be tracking the use of these chemicals now. Required PFAS reporting for TRI Reporting Year 2022 is due on July 1, 2023.

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Draft Model State PFAS Legislation: A More Holistic Approach To Regulating "Forever Chemicals" in Consumer Products https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/draft-model-state-pfas-legislation-a-more-holistic-approach-to-regulating-forever-chemicals-in-consumer-products https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/draft-model-state-pfas-legislation-a-more-holistic-approach-to-regulating-forever-chemicals-in-consumer-products Mon, 22 May 2023 12:29:15 -0400 A recent Kelley Drye client advisory summarizes important new draft model state legislation that embodies an expansive approach to the regulation of per- and polyfluoroalkyl substances (PFAS) in consumer products. Crafted by the Northeast Waste Management Officials’ Association, Inc. (NEWMOA) and released earlier this month, the Draft PFAS Prevention Model Act (Draft Model) offers a menu of policy options for state legislatures to address potential PFAS contamination and exposure from consumer products. Most notably, the Draft Model includes a near-total ban on PFAS-containing consumer products within three years, product reporting requirements, "extended producer responsibility" obligations (i.e., product "take back"/recycling programs), and a new multi-jurisdictional “clearinghouse” to assist state environmental agencies with compliance and enforcement of the act.

The Draft Model reflects a move by states towards a more holistic approach to the regulation of PFAS in products. In recent months, states are trending from product-specific bans (such as for food packaging, cosmetics, textile treatments, cookware, carpets, furniture, etc.) to broad-based bans with limited exceptions, and, increasingly, reporting and labeling requirements (such as in Maine). The Draft Model take this trend a step (or two) further with the groundbreaking "clearinghouse" proposal, which would

maintain a database of all products containing PFAS, including PFAS-added products; a file on all exemptions granted by the participating jurisdictions; a file on alternative labeling plans; and a file of all the manufacturers’ reports on the effectiveness of their collection systems.

Moreover, the Draft Model introduces "end-of-life" EPR requirements into the PFAS regulatory universe.

NEWMOA is taking comments on the Draft Model until June 29.

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Maine Readies Proposed Rule on PFAS in Food Packaging https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/maine-readies-proposed-rule-on-pfas-in-food-packaging https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/maine-readies-proposed-rule-on-pfas-in-food-packaging Thu, 04 May 2023 14:03:28 -0400 The Maine Department of the Environment (DEP) plans to propose a long-awaited rule later this year aimed at eliminating per- and polyfluoroalkyl substances (PFAS) in food packaging. The proposed rulemaking was announced to state lawmakers by a DEP representative at a legislative hearing in late April, which also included discussions on a slew of recent proposals to amend Maine’s landmark 2021 law to ban PFAS in most other consumer products.

In 2019, Maine's Toxic Chemicals in Food Packaging Act, in addition to banning phthalates in food packaging by 2022, authorized DEP to pursue a similar ban for PFAS. Before adopting such a ban, the law requires DEP to evaluate the cost and availability of PFAS-free food packaging substitutes. The Department has made several attempts to collect information on PFAS-free substitutes in recent years, but, according to DEP, has not as yet received meaningful industry input. The planned rulemaking will build off a 2022 Washington state report on PFAS-free packaging substitutes and seek formal public comment on the feasibility of a ban.

The announcement comes several months after DEP changed course on whether manufacturers and distributors of PFAS-containing food packaging were subject to the 2021 law requiring reporting on PFAS-containing products by January 1 of this year. Originally, the Department planned to include food packaging within the reporting requirement, but in December decided that the 2019 law provided an exemption.

Meanwhile, DEP is taking comment until May 19 on a proposed rule to clarify implementation of the 2021 law's reporting requirements. A final rule is expected this summer. Maine is the first state to adopt a broad program to report on uses of PFAS in products and other states are watching closely (e.g., California, where the governor recently vetoed a reporting program as premature, and Minnesota, which is set to adopt a program similar to Maine).

In addition, the Maine legislature is considering five different bills that would amend the 2021 law. These bills would redefine the types of PFAS covered by the law, exempt businesses of 10 employees or less, and extend by up to one year the reporting deadlines for manufacturers and users of PFAS. Further coverage of these bills is available here.

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Minnesota Considering Extensive Reporting Requirements and Ban on PFAS in Consumer Products https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/minnesota-considering-extensive-reporting-requirements-and-ban-on-pfas-in-consumer-products https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/minnesota-considering-extensive-reporting-requirements-and-ban-on-pfas-in-consumer-products Fri, 28 Apr 2023 06:30:00 -0400 Last week, the Minnesota House passed the state’s largest-ever environmental and natural resources funding bill, including a ban on per- and polyfluoroalkyl substances (“PFAS”) in many consumer products beginning in 2025, with a ban on most such applications in 2032. If passed in the Senate and signed by the Governor, The Gopher State would be the second state, after Maine, to impose near-total restrictions on PFAS in consumer products.

HF2310 builds on previous state legislation that never was voted upon. Specifically, the Minnesota Senate introduced SF834 in January earlier this year, which provided for softer PFAS regulations than HF2310. Meanwhile in the Minnesota House, HF1000 also was discussed, but never voted upon. It too would have provided more tempered restrictions on PFAS.

Now paired with an omnibus bill that includes $670 million in funding to various Minnesota agencies, HF2310 would prohibit the sale, offering for sale, or distribution for sale of a wide range of consumer products containing intentionally added PFAS. The following products would be prohibited from containing intentionally added PFAS by 2025: carpets and rugs, cleaning products, cookware, cosmetics, dental floss, fabric treatments, juvenile products, menstruation products, textile furnishings, ski wax, and upholstered furniture.

Additionally, manufacturers of all other products containing PFAS will be required to report their use of these chemicals to the Minnesota Pollution Control Agency by January 1, 2026. A broader ban on the use of PFAS in products would go into effect on January 1, 2032, with exemptions for “unavoidable use” to be determined by the Minnesota Pollution Control Agency based on submitted use data in accordance with an upcoming rulemaking.

The bill echoes legislation adopted by Maine in 2021, which banned PFAS in textiles, carpets and rugs as of January 2023, required manufacturers of other PFAS-containing products to report their PFAS uses by that same date, and imposed a ban on PFAS in most products by 2030. Maine’s Department of Environmental Protection acknowledged last year that a rule would not be in place until later this year, even though businesses were still required to begin reporting by this past January 1. Interestingly, Maine regulators have granted hundreds of company and group-specific extensions on the reporting requirements, despite the Department still working on crafting implementing rules.

HF2310 passed by a vote of 69-59, and has since been passed on to the Minnesota Senate for their review.

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