Agencies and Regulated Community Brace for Changes in Administrative Law and a Potential “Flood of Litigation”

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.

EPA’s PFAS Reporting Rule Requires Data Going Back to 2011

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.

EPA Looking to Expand PFAS Substances Regulated under Superfund

2,014,777 Chemical Images, Stock Photos & Vectors | Shutterstock

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.

EPA Now Taking Comments on Its PFAS Enforcement Discretion Policy

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.

PFAS Limits in Public Drinking Water Set Forth in Proposed EPA Rule

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.

PFAS – Pennsylvania DEP Adopts new limits on 2 PFAS Chemicals – Required Testing, Reporting and Treatment

Earlier this past week, the Pennsylvania Department of Environmental Protection (“DEP”) adopted new limits on two classes of PFAS chemicals.

Pennsylvania joins a growing list of states that have implemented limits and, in some cases, bans, on certain types of PFAS and PFOS chemicals. According to the new rule, Pennsylvania will now mandate that all public and private drinking water treatment facilities in the Commonwealth, together with schools and healthcare facilities, and  commercial bottled water plants, will all be required to test their water for PFAS and PFOS, report the findings and treat affected water for the chemicals present above the new maximum contaminant levels (MCLs).

Pennsylvania’s new regulations will restrict the PFAS compounds PFOS (perfluoro-octane sulfonic acid) at 14 parts per trillion, and PFOA (perfluorooctanoic acid) at 18 parts per trillion.

Studies have indicated that over 97% of all humans have PFAS compounds in their blood stream that bio accumulates over time.

For decades, PFAS chemicals have been widely used in consumer products such as cosmetics, personal care products, furniture stain resistant applications, carpet stain guard, flame retardant fire fighting  foam (including foam used at all airports in the US), non-stick cookware, flame-retardant clothing, weather resistant outdoor clothing, some food packaging, as well as in firefighting foam used at current and decommissioned military bases.

While the new DEP regulations set the MCLs for these chemicals for the first time in Pennsylvania, critics have pressed for a lower MCL, for more PFAS compounds to be regulated and for private wells to be protected. 

New Jersey recently proposed a 4-bill set of additional PFAS restrictions and already restricts PFAS at 13 parts per trillion for PFOS and PFNA, and 14 parts per trillion for PFOA. Delaware is also considering regulations akin to Pennsylvania’s and has proposed implementing its own MCLs.

At the federal level, the Environmental Protection Agency is continuing to study PFAS and had set a federal health advisory level for PFAS, but unlike the PA MCLs, the federal advisory is just that, advisory, and, as such, is not per se actionable. As part of its ongoing effort to study and limit the effects of PFAS, in June, 2022, the EPA revised its prior advisory guidance set in 2016 at 70 parts per trillion down to .004 parts per trillion, after announcing the compounds were more concerning than EPA had previously thought.

Key Take Away – Pennsylvania joins a growing list of states that are actively reviewing and setting standards on what is acceptable and not in drinking water, soil, products, food packaging, and other consumer products. The new PA rule will require testing, reporting and treatment for affected water which exceeds the noted standard.

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 discussion 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 Lindsay Brown, Brad A. Molotsky, Alyson Walker Lotman, Alice Shanahan,  Seth Cooley, 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.

PFAS – Request for Public Comment on Data Collection regarding “Human Health Effects of Drinking Water Exposures to Per-and Polyfluoroalkyl Substances: A Multi-Site Cross Sectional Study”

Earlier this week, the Agency for Toxic Substances and Disease Registry (“ATSDR”) issued a notice – “Proposed Data Collection Submitted for Public Comment and Recommendations”.

The notice was published in the Federal Register on January 11, 2023 by Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention (the “Notice”).

ATSDR is asking the general public and other federal agencies to comment on a continuing information collection as required by the Paperwork Reduction Act . This notice requests comment on a proposed information collection project entitled “Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS): A Multi-Site Cross-Sectional Study (the Multi-Site Study)”. The goal of the research is to develop and deploy sound study methods to better determine if and how drinking water exposure to PFAS is related to health outcomes.

ATSDR is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and

5. Assess information collection costs

Per the Notice, ATSDR seeks to cumulatively enroll approximately 9,100 participants (7,000 adults and 2,100 children and their parents) from communities exposed to PFAS-contaminated drinking water. In total, each recipient will attempt to meet a target recruitment of 1,000 adults and 300 children. Annualized estimates are 3,033 participants (2,333 adults and 700 children). Over the first three years of the five-year cooperative agreement program, the recipients have enrolled over 3,000 adults and over 300 children (as of 11/17/2022). The enrollment of children has been especially challenging during and following major closures and access to schools and other educational facilities due to the COVID-19 pandemic.

Further, according to the Notice, the main goal of the cross-sectional study is to evaluate associations between measured and reconstructed historic serum levels of PFAS including PFOA, PFOS, and PFHxS, and selected health outcomes. The health outcomes of interest to the ADSDR include lipids, renal function and kidney disease, thyroid hormones and disease, liver function and disease, glycemic parameters and diabetes, as well as immune response and function in both children and adults. In addition, the study has been designed to investigate PFAS differences in sex hormones and sexual maturation, vaccine response, and neurobehavioral outcomes in children. In adults, additional outcomes of interest by the ATSDR include cardiovascular disease, osteoarthritis and osteoporosis, endometriosis, and autoimmune disease.

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7118; Email:

If interested in the full text of the Notice, please see attached:

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 discussion 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 Lindsay Brown, Brad A. Molotsky, Alyson Walker Lotman, Alice Shanahan,  Seth Cooley, 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.

PFAS – The “Preventing PFAS Runoff at Airports Act” signed into law

Earlier this week, President Biden signed the Bipartisan “Preventing PFAS Runoff at Airports Act” (the “Act”) that was authored by Senator Gary Peters (MI).

The Act will enable spending from the Federal Aviation Administration (the “FAA”) to commercial airports in the US for the airports to purchase testing equipment to be used on fire fighting devices to confirm if the fire fighting equipment has been impacted or contaminated with PFAS.

The testing devices are commonly referred to as “input-based testing systems” and are designed to limit and prevent exposure to PFAS by the fire fighters using the equipment. Continue reading “PFAS – The “Preventing PFAS Runoff at Airports Act” signed into law”

© 2009- Duane Morris LLP. Duane Morris is a registered service mark of Duane Morris LLP.

The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

Proudly powered by WordPress