In a step toward increased regulatory attention on so-called forever chemicals, California Governor Gavin Newsom recently signed into law two bills requiring manufacturers to limit the amount of per-and poly-fluoroalkyl substances (PFAS) in particular products.
Read the full Alert on the Duane Morris LLP website.
The U.S. Environmental Protection Agency (EPA) is proposing to add 16 individually listed per- and polyfluoroalkyl substances (PFAS) and 15 PFAS categories―representing more than 100 individual PFAS―to the Toxics Release Inventory (TRI) list of toxic chemicals subject to reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA). In addition, EPA is proposing to reclassify over 35 previously listed PFAS into these chemical categories, which will impact the calculation of reporting thresholds for the reclassified chemicals.
Read the full Alert on the Duane Morris website.
On May 1, 2024, Colorado enacted the “Perfluoroalkyl and Polyfluoroalkyl Chemicals Consumer Protection Act” (the “PPCCA“) to establish a regulatory scheme that prohibits the sale or distribution of certain products that contain intentionally added perfluoroalkyl and polyfluoroalkyl chemicals (PFAS).
The full bill – SB 081 can be found here https://legiscan.com/CO/text/SB081/2024
As of January 1, 2024, the PPCCPA, restricts the sale and distribution of each of the following products in Colorado if the products contain intentionally added PFAS chemicals:
In addition, after January 1, 2024, a manufacturer of cookware sold in Colorado that contains intentionally added PFAS chemicals in the handle of the product or in any product surface that comes into contact with food, foodstuffs, or beverages is required to:
Further, per the PPCCA, after January 1, 2024, a manufacturer of cookware is prohibited from making a statement that the cookware is free of PFAS chemicals unless no individual PFAS chemical is intentionally added to the cookware.
On and after January 1, 2025, the sale or distribution in Colorado of any products in the following product categories is prohibited if the products contain intentionally added PFAS chemicals:
On and after January 1, 2027, the sale or distribution in Colorado of any of the products in the following product categories is prohibited if the products contain intentionally added PFAS chemicals:
Moreover, manufacturers and distributors should also be aware that the PCCAA includes products that do not contain intentionally added PFAS chemicals in the definition of “environmentally preferable products” for the purposes of state agency procurement.
The PPCCA also:
Duane Morris has an active PFAS team to help organizations and individuals plan, respond to and execute on PFAS issues and initiatives in order to manage risk, ensure compliance and minimize litigation risk. We are available to discuss your concerns and objectives and how new rules, regulations and rulings might apply to you.
For More Information:
If you have any questions about this post, please contact Lindsay Ann Brown, Lori A. Mills, Brad A. Molotsky, any of the attorneys in our PFAS Group or the attorney in the firm with whom you are regularly in contact.
Earlier this week, I had the pleasure of moderating our inaugural webinar session on PFAS – PFAS What You Need to Know. I was joined by fellow Partner Lindsay Brown of our Cherry Hill office, Larry Gottlieb, President and Chief Innovation Officer at ResinTech, and Colleen Costello and Thomas Geiger of Sanborn.
We spent the hour discussing many things PFAS related including, that in the panelists experience, the number of people and the knowledge base and visibility of PFAS in the environment and in products we use in our offices and homes has increased markedly in the last 3-5 years. Despite this consumer and legal focus in the PFAS arena, it was felt that the medical profession, as a whole, has not focused on the impact to their patients and how to treat PFAS in the blood stream as of yet in an adequate way.
We reviewed how PFAS is a man-made substance that was created in the United States in a lab in the 1930’s and that it worked for its intended purpose – meaning, it is a very strong chemical and has incredibly strong bonds; it repels water as it was intended and it works well. The unintended consequences of how far reaching the chemicals would flow and how quickly they would move in water and how they would find their way into various products in the home and the work place and what lingering health impacts to fish, animals and humans is still playing itself out in numerous studies that have been conducted over the last 7 years and counting. A massive uptake in litigation and class action lawsuits have proliferated over the past decade against the original 20 manufacturers of PFAS and these numbers continue to rise.
While the panelists pointed out that due to the danger of the chemicals, some PFAS have been phased out, they also noted that according to the National Institute of Environmental Health there are over 12,000 different types of PFAS – including PFOA (perfluorooctanoic acid) and PFOS (perfluorooctanesulfonic acid – an 8-carbon chain), many of which continue to be unregulated at the federal and state level.
We discussed various industries that have utilized PFAS in their products or in their manufacturing processes in the past including fire fighting foam, fire protection equipment, plastic manufacturing, synthetic fiber manufacturing, metal finishing and coating, textile mills, furniture manufacturing, leather and tanning operations, paper manufacturing, at airports, and in various consumer goods including cosmetics, fabric treatments, dental floss, toothpaste, toilet paper, ski wax and cookware, grease resistant paper, microwave popcorn bags, pizza boxes, candy wrappers as well as in resistant coatings on carpet, upholstery and furniture and plastic wrapping for food.
So what is the big deal? The group discussed that the big deal is that the PFAS family of chemical compounds do not degrade in the environment, whether in water or in soil and are now found in fish, animals and humans around the globe. Given its strength, PFAS tends to bioaccumulate in humans and animals – meaning it does not leave our blood stream once it enters it and it accumulates as we continue to be exposed to more and more PFAS.
Some of the potential health impacts that the National Institute of Health and the EPA have focused on include developmental delays, hormonal imbalances, birth defects, testicular and kidney cancers, liver issues and endocrine disruption.
The panel discussed how PFAS has historically been measured, where it has been measured at all. In many chemicals, measurements are done in part per million (PPM) or, in some instances, parts per billion (PPB) but that the EPA has determined that quantities of PFAS that exceed 4 part per trillion (PPT) are dangerous to humans if consumed in drinking water. A useful analogy provided by the panel is that we are talking about a danger level at a tea spoon worth of PFAS in 20 Olympic sized pools was
While awaiting EPA regulations on drinking water standards, many states enacted their own standards of 50 PPT or 15-20 PPT and these states will now need to re-evaluate and revise their standard in light of the recently announced EPA standard of 4 PPT. States that have no PFAS standard will now also be subject to the federal standard of 4 PPT.
We also discussed that under the Toxic Release Inventory (TRI) Reporting requirements, new reporting obligations have been enacted which are now in effect and which will require 189 different PFAS to report under its required reporting regime. Historically, reporting was triggered from 100 pounds of PFAS or more but, starting in 2025, 7 new PFAS constituents have been added to the list of “chemicals of special concern” where no de minimis quantity exemption will apply. Other reporting rules for PFAS under the Toxic Substances Control Act of 1976 (TSCA) have also been implemented which will require certain importers and manufacturers of products with PFAS in the products to review their records and look back to 2011 and report on the amount of PFAS being used in such products.
Furthermore, we chatted about remediation techniques, including trapping PFAS at receptors and point sources to limit the amount of PFAS escaping into our ground water, as well as the “pump and treat technique” of such water and how to address impacted group water via granular activated carbon (GAC) and via ion exchange (IX) but, that these techniques, while very efficient at trapping the PFAS, do not eradicate it rather they merely separate it from the impacted water. To truly eradicate the PFAS and not create off gassing into the air that will then likely impact surrounding soil around the off gassing, one would need to incinerate the PFAS to a temperature of approximately 1750 F (noting most incinerators do not get close to this temperature) in order to cause the PFAS to break down into its constituent elements of carbon and fluorine. Not to give up hope, many technologist are focusing on how to remove the PFAS from various media (i.e., water, soil, etc.), and then how to destroy the PFAS in bulk using innovative techniques that include plasma, hot plasma, supercritical water oxidation (SCWO) and ionic gasification.
We wrapped up the hour touching on how the EPA has just, as of last week, declared certain PFAS to be a “hazardous substance” under CERCLA and, with this designation, under the law, strict liability will attach to the producer or seller of the product or for the owner of the site or building or use of the site or building that has the PFAS issue, irrespective of fault. As such we all agreed that a focus on risk mitigation, insurance, allocation of who bears what risk in a sale, lease, purchase and product delivery system are key areas to consider as the law continues to evolve and class action lawsuits continue to proliferate in the arena.
For more information on PFAS, the panel’s favorites include WQA.org, the EPA’s PFAS site and PFAS toolkit, the ITRC guide on PFAS and the NJDEP site and its PFAS tab.
Duane Morris has an active PFAS team to help organizations and individuals plan, respond to and execute on PFAS issues and initiatives in order to manage risk, ensure compliance and minimize litigation risk. We are available to discuss your concerns and objectives and how new rules, regulations and rulings might apply to you.
If you have any questions about this Alert, please contact Lindsay Ann Brown, Lori A. Mills, Brad A. Molotsky, any of the attorneys in our PFAS Group or the attorney in the firm with whom you are regularly in contact.
EPA Takes Another Step Toward Regulation of PFAS Air Emissions
Although not yet enforceable, the release of draft test method OTM-50 by the U.S. Environmental Protection Agency (EPA) marks another step toward the regulation of per- and polyfluoroalkyl substances (PFAS) in air emissions, as it will facilitate the gathering of data and refinement of test methods necessary to develop air emissions standards. As part of its release, EPA Assistant Administrator for Research and Development Chris Frey noted that OTM-50 is intended to apply to chemical manufacturers, industrial users of PFAS and PFAS-destruction technologies. Its applicability is likely to broaden into other industries, however, as EPA’s understanding of PFAS in air emissions evolves. EPA also published a related FAQ.
While much of the recent focus on PFAS exposure has centered on water contamination and household products, EPA has increasingly set its sights on air emissions as a target route of exposure requiring regulation. Indeed, one of the central missions laid out in EPA’s 2021 “PFAS Strategic Roadmap: EPA’s Commitments to Action 2021-2024” is to build the technical foundation necessary to regulate PFAS in air emissions.
In line with this objective, EPA released the draft test method in January to measure 30 volatile, nonpolar fluorinated compounds (VFCs), including certain PFAS, in air emissions released from stationary sources. The draft test method, titled “Other Test Method 50 (OTM-50): Sampling and Analysis of Volatile Fluorinated Compounds from Stationary Sources Using Passivated Stainless-Steel Canisters,” builds on OTM-45, a test method released by EPA in 2021 and used to measure approximately 50 polar (semi-volatile and particulate-bound) PFAS in air emissions.
The EPA summary document accompanying OTM-50 acknowledges the current lack of standardized methods to measure PFAS and VFCs in air emissions. This invites a host of issues, including “inconsistent findings, incomparable measurements, and lack of coordination between policy makers, facilities, and control technology development.” With the release of OTM-50, EPA aims to provide a consistent testing method that it believes reflects current best practices to sample and analyze certain PFAS and VFC targets from stationary sources, including vents and stacks.
EPA had indicated in December that it was aiming to release OTM-50 together with its updated, interim PFAS destruction and disposal guidance. However, the guidance remains under review by the White House Office of Management and Budget. OTM-50 may be particularly useful in measuring industrial compounds and products of incomplete combustion/destruction tied to incinerator emissions. Incineration is a method being considered by EPA as part of its interim PFAS destruction and disposal guidance.
EPA’s summary document notes that its release of OTM-50 is not an endorsement or a regulatory approval of the test method and that OTM-50 may ultimately be implemented by EPA, state or local authorities through independent actions. Better detection of air emissions through reliable testing methods, including OTM-50, will only encourage the eventual regulation of air emissions, particularly around incineration and combustion of PFAS.
Duane Morris has an active PFAS Team to help organizations and individuals plan, respond to, and execute on your PFAS issues and initiatives. We would be happy to discuss your concerns and objectives and how new rules, regulations and rulings might apply to you.
For More Information
If you have any questions about this post, please contact Lindsay Ann Brown or Louis C. Formisano, the authors, Sharon Caffrey, Brad A. Molotsky, Alice Shanahan, Seth Cooley, Alyson Walker Lotman, Lori Mills or Kelly Bonner, the attorneys in our PFAS Working Group or the attorney in the firm with whom you are regularly in contact.
Agencies and Regulated Community Brace for Changes in Administrative Law and a Potential “Flood of Litigation”
Recent oral argument before the Supreme Court of the United States has raised significant questions concerning the Chevron doctrine, a 40-year-old ruling that requires federal courts to defer to an agency’s reasonable interpretation of certain statutory provisions that Congress charged the agency with implementing. Because a majority of the Supreme Court appears inclined to overturn or at least modify that doctrine, many in the regulated community are bracing for potentially significant changes in the administration of regulatory law. Still others are warning that there may be a “flood of litigation” seeking to overturn prior decisions that relied on the doctrine. The Supreme Court’s decision on the issue is expected before July 2024.
Chevron History and the Debate
The doctrine of Chevron deference was first announced by the Supreme Court in 1984 in the matter Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 83. Pursuant to the doctrine, if Congress charges an agency with implementing a statute, and that statute is silent or ambiguous with respect to a specific issue, the court should defer to an agency’s reasonable interpretation of the statute as it pertains to that issue.
Proponents of the doctrine claim it fosters separation of powers because interpretation of an ambiguous statute “requires the formulation of policy.” If Congress explicitly or implicitly delegated policymaking authority to the agency, the court should defer to the reasonable judgment of the agency rather than imposing its own policy preferences. According to proponents of the doctrine, agencies are better suited to make such policy decisions because they are viewed as experts in their particular field and they are accountable to an elected president.
Opponents of Chevron, however, claim the opposite. They claim Chevron should be overturned because the doctrine violates Article III of the Constitution and the power of federal judges to interpret the law. According to them, Chevron has for years been wrongly treating legal questions as policy questions and reallocating judicial authority to the agencies. Opponents argue that, in cases where an agency is not involved, there is no question that the court has the duty to interpret ambiguous statutory provisions. Absent an express delegation of that duty to the agency, the same analysis should apply in cases where an agency is involved.
Proponents and opponents of the doctrine similarly differ on whether Chevron promotes or destroys uniformity in the law. Proponents of the doctrine claim Chevron promotes uniformity by having a singular entity―the agency―decide on the appropriate implementation of a statute. Absent Chevron, such decisions would be subject to disputes among the lower courts, creating different rules in different parts of the country for regulated parties. Opponents claim Chevron facilitates “flip-flopping,” with agency rules being subject to change each time a new administration is ushered into office.
Recent Supreme Court Argument
It appears the Supreme Court is poised to overturn or modify the application of Chevron deference. On January 17, 2024, the Court heard oral argument in two cases, Loper Bright Enterprises, Inc. v. Raimondo and Relentless Inc. v. Department of Commerce, which challenge a National Marine Fisheries Services (NMFS) rule implemented under the Magnuson-Stevens Act. The act authorizes the NMFS to require fishing vessels to carry federal observers but it is silent on the issue of whether those vessels should be required to pay the salaries of the observers. The NMFS promulgated a rule that required the vessels to pay these salaries. Plaintiffs brought suit claiming the rule exceeded NMFS’s statutory authority. Applying the Chevron deference, the district courts in each case upheld the rule and the circuit courts affirmed. The Supreme Court granted certiorari to decide whether it should overturn or modify the doctrine of Chevron deference.
During three and a half hours of oral argument, Justices Neil Gorsuch, Samuel Alito and Brett Kavanaugh all appeared to favor overturning Chevron with comments supporting the notion that Chevron violates that traditional separation of powers, impermissibly tilting the balance of power to the executive branch, and that application of the doctrine fosters instability by allowing changes “every four to eight years when a new administration comes in.” Comments from Justices Elena Kagan, Sonia Sotomayor and Ketanji Brown Jackson, on the other hand, appeared to be in favor a decision that will preserve Chevron, commenting, inter alia, that deference to the implementing agency most aligns with congressional intent. Chief Justice John Roberts and Justices Amy Coney Barrett and Clarence Thomas were more difficult to read, expressing reservation about overturning the doctrine, particularly whether it would “invit[e] a flood of litigation.”
Implications for Overturning or Modifying Chevron
In the event Chevron is overturned, one of the biggest unanswered questions is the fate of prior regulations and decisions that relied upon the doctrine. Petitioners in Loper and Relentless argued that, under principles of stare decisis, prior decisions likely would remain intact, since the ultimate holding in those cases was the agency’s action was lawful. Moreover, if the Court decides to overturn Chevron, it could fashion a prospective ruling that leaves any past decisions in place. Not all of the justices appeared mollified by petitioners’ response to these concerns.
Obviously, it remains to be seen whether the Court will overturn, modify or affirm Chevron. However, most commentators agree that some change is in the cards, and any change is likely to usher in a period of uncertainty and challenge―especially for more complex and detailed regulatory programs, such as those implemented by the Centers for Medicare and Medicaid Services, Environmental Protection Agency, Food and Drug Administration, Department of Health and Human Services, Consumer Product Safety Commission, Federal Trade Commission, Board of Immigration Appeals and Internal Revenue Service, to name just a few.
Congressional Oversight of Rulemaking
While the Supreme Court is grappling with questions of Chevron deference and separation of powers, in Congress, a group of lawmakers is considering options to expand congressional oversight of rulemaking by the executive branch. On January 9, 2024, the Government Accountability Office issued a revised report, “Options for Enhancing Congressional Oversight of Rulemaking and Establishing an Office of Legal Counsel,” that evaluates options for enhanced oversight of agency action, including creating a new Congressional Office of Regulatory Review. That report warns that increased congressional oversight of agency rulemaking will likely carry burdens of increased costs, inefficiencies and duplication of efforts.
For More Information
If you have any questions about this Alert, please contact Sharon Caffrey, Lindsay Brown, any of the attorneys in our Trial Practice Group or the attorney in the firm with whom you are regularly in contact.
On September 28, 2023, the U.S. Environmental Protection Agency (EPA) released its final Toxic Substances Control Act (TSCA) Section 8(a) reporting rule. It expands reporting and recordkeeping requirements for companies that have manufactured or imported per- and polyfluoroalkyl substances (PFAS) for a commercial purpose—whether as a chemical substance or in a mixture or article—since January 1, 2011. Entities subject to this rule will need to submit reporting forms for retrospective data either 18 or 24 months following the rule’s effective date, which is 30 days after its publication in the Federal Register.
Read the full Alert on the Duane Morris LLP website.
On September 6, 2022, the United States Environmental Protection Agency (“USEPA”) had previously issued a notice of proposed rulemaking to designate two (2) specific PFAS substances, known as perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as CERCLA hazardous substances. We have previously blogged about this Notice and it can be found on our website if of interest. The comment period to that proposed rulemaking has now closed and USEPA is presently evaluating comments received.
In the meantime, however, USEPA is considering a new initiative to expand the list of Comprehensive Environmental Response, Compensation and Liability Act (“CERCLA”) regulated PFAS beyond PFOA and PFOS to include seven (7) additional PFAS, their salts and precursors and, possibly, certain categories of PFAS.
In a pre-publication notice issued by the USEPA on April 13, 2023 (to be published in the Federal Register on that same date), USEPA announced its intention to consider expansion of its CERCLA hazardous substances list developed under potentially to include seven (7) additional per- and polyfluoroalkyl substances (PFAS) on that list.
As set forth in the pre-publication notice, additional PFAS under consideration for regulation includes:
• Perfluorobutanesulfonic acid (PFBS), CASRN 375-73-5;
• Perfluorohexanesulfonic acid (PFHxS), CASRN 355-46-4;
• Perfluorononanoic acid (PFNA), CASRN 375-95-1;
• Hexafluoropropylene oxide dimer acid (HFPO-DA), CASRN 13252-13-6 (sometimes called GenX);
• Perfluorobutanoic acid (PFBA) CASRN 375-22-4;
• Perfluorohexanoic acid (PFHxA) CASRN 307-24-4; and
• Perfluorodecanoic acid (PFDA) CASRN 335-76-2.
Take Aways:
USEPA will also be giving consideration to the precursors to PFOA, PFOS, and other PFAS listed above as well as whether USEPA should take action to designate whole categories of PFAS based on shared characteristics among the PFAS listed in those categories.
To these ends, USEPA is seeking a variety of data sources and information to assist them is deciding whether to expand the CERCLA list. The Comment period will run until approximately July 6, 2023 (i.e., sixty (60) days from publication in the Federal Register which is anticipated on April 13, 2023).
Duane Morris has an active PFAS Team to help organizations and individuals plan, respond to, and execute on your PFAS issues and initiatives. We would be happy to discuss your concerns and objectives and how new rules, regulations and rulings might apply to you. For more information or if you have any questions about this post, please contact Lori Mills, the author, or Lindsay Brown, Sharon Caffrey, Brad A. Molotsky, Alice Shanahan, Seth Cooley, Alyson Walker Lotman, Kelly Bonner, Sharon Caffrey or the attorney in the firm with whom you in regular contact or the attorney in the firm with whom you are regularly in contact.
On September 6, 2022, the U.S. Environmental Protection Agency (EPA) issued its proposed rulemaking to designate certain per- and polyfluoroalkyl substances (PFAS) as Hazardous Substances under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), which would have a significant legal impact across the country and create potential liability for PFAS release and/or contamination for a broad set of entities in numerous industries. Accordingly, the EPA has been developing an enforcement discretion policy and recently concluded two public listening sessions to seek stakeholder input on concerns about CERCLA enforcement for PFAS contamination. The EPA will review and consider the input received as it finalizes the CERCLA PFAS enforcement discretion policy.
Read the full text of this Alert on the Duane Morris LLP website.
On March 14, 2023, the Environmental Protection Agency (EPA) announced a proposed new National Primary Drinking Water Regulation (NPDWR), which standardizes and sets the legally enforceable maximum contaminant levels (MCLs) of six per- and polyfluoralkyl substances (PFAS) in drinking water. The proposed regulation also sets nonenforceable maximum contaminant level goals (MCLGs).
Read the full text of this Alert on the Duane Morris LLP website.
