Summary
- The Science and Technology Committee Report for The Year in Review 2024.
- Summarizes significant legal developments in 2024 in the area of science and technology, including the Science Advisory Board, PFAS policies, and more.
The scientific advisory boards that advise the federal environmental agencies remain contested political and legal grounds, as exemplified by the June 2024 decision in Young v. EPA. This case highlights the growing role of the Federal Advisory Committee Act (Advisory Committee Act) as a tool for contesting agency decision-making in the face of evolving administrative priorities. Among the committees governed by the Advisory Committee Act are the Science Advisory Board (SAB or Board) and the Clean Air Scientific Advisory Committee (CASAC), which play a pivotal role in reviewing the scientific and technical basis for EPA regulations. Given their influence, the independence and composition of these committees have become key concerns for incoming EPA administrators.
In 2021, Biden-appointed EPA Administrator Michael Regan reconstituted the previous administration’s SAB and CASAC, dismissing all prior members and considering hundreds of nominees for those committees. While the Administrator reappointed some members, the Administrator declined to reappoint Dr. Stanley Young and Dr. Anthony Cox, who were known for their industry ties.
Young and Cox filed suit, alleging that the appointment process violated the Advisory Committee Act and the Administrative Procedure Act (APA). Specifically, they argued that the committees were not “fairly balanced” as required by the Advisory Committee Act as the result of a biased selection process. They further claimed that the EPA failed to adequately explain how its selection process complied with the Advisory Committee Act. After the District Court granted EPA’s motion for summary judgment on the CASAC issues, Cox and Young appealed to the D.C. Circuit.
Rather than ruling on the merits, the Court of Appeals sua sponte addressed the issue of standing under Article III of the United States Constitution. The Plaintiffs’ theories of standing rested on three claims: 1) alleged bias based on race and sex, 2) viewpoint bias against opponents of stricter air quality standards for fine particulate matter (PM2.5), and 3) loss of benefits associated with committee membership. In rejecting these theories, the Court focused on the first element of the three-part Lujan test—whether a plaintiff can demonstrate an “injury-in-fact.”
First, while acknowledging that unequal treatment of candidates could in some instances, amount to an injury-in-fact, it found that the Plaintiffs failed to preserve this theory by not raising an Equal Protection or similar claim in their complaint. The isolated mention of race and sex as factors that “compounded” other alleged errors was insufficient to present the issue on appeal.
Second, the Plaintiffs argued that the absence of viewpoints opposing stricter air quality regulations for PM2.5 evidenced bias in the selection process. The Court rejected this alternative theory of injury, noting that CASAC's composition could not feasibly capture every perspective within its limited seven-member structure. Additionally, the Court referenced National Anti-Hunger Coalition v. Executive Committee of President’s Private Sector Survey of Cost Control, to affirm that only individuals with a direct regulatory interest in a committee’s work can assert a cognizable injury under the Advisory Committee Act. Because the Plaintiffs, as scientific consultants, did not have such an interest, the Court further found their injury claims lacking.
As to the third theory, the Court held that the loss of benefits associated with committee membership, such as prestige, did not constitute a cognizable injury. Because the Advisory Committee Act does not create an entitlement to committee membership, it similarly does not confer a right to the incidental benefits of such appointments.
Finally, the Court dismissed the Plaintiffs’ APA-based claim, which alleged that the EPA failed to adequately explain how it complied with the Advisory Committee Act. Without an independent injury to support standing, this claim failed as a derivative of the other insufficient theories.
Ultimately, the D.C. Circuit vacated the District Court’s Order and remanded with instructions to dismiss the CASAC claims for lack of standing. This decision reaffirmed the limited scope of judicial review in disputes over advisory committee appointments, leaving broader questions about balance and bias unresolved. This decision also suggests that any future claimants with challenges must demonstrate direct and actual injury in order to survive challenges to their constitutional standing.
In 2024, the SAB issued 12 advisory reports on its findings to the EPA. The reports ranged from review of EPA methodology for specific compounds such as inorganic arsenic to broader reports on environmental justice mapping and related EPA initiatives.
In January 2024, the Board issued its report on EPA’s new methodology for calculating the benefits for reducing PM2.5 particulates and a mapping software tool known as “BenMAP.” As described by EPA, the BenMAP software system is designed to assist in calculating the potential benefits for a given regulatory action designed to reduce PM2.5 or ozone:
The EPA’s Guidelines for Preparing Economic Analyses describe the purpose of benefit-cost analysis (BCA), related economic analyses, and the best-practices for conducting them ((U.S. EPA 2014)). BCA is the primary tool used for regulatory analysis and is used to inform the decision of whether the benefits of an action are likely to justify the costs ((Exec. Order No. 12898 (1994), (OMB 2003)).
The Board reviewed the BenMAP software and the accompanying Technical Support Document in 2023 and reported its conclusion that while overall the combined documents “are scientifically robust and appropriate for regulatory analysis,” there were certain specific recommendations to improve the documents.
The Board engaged in EPA efforts to promote environmental justice. In November 2024, the Board transmitted its report on a review of EPA’s “Technical Guidance for Assessing Environmental Justice in Regulatory Analysis.” Again, the Board generally agreed with many of the conclusions but urged EPA to refine its approach by, among other things, including discussion of precision and error and uncertainty in data estimates and predictions.
In December 2024 the Board issued a report that it independently initiated on “Advancing Environmental Justice Science in Rulemaking.” Rather than commenting on a specific EPA guidance or technical document, this report took a more holistic approach to environmental justice. The report recommended using consistency in terms such as “impact” or “community” and called for the Agency to adopt a consistent training program for its own staff on understanding implicit bias and racial equity.
The current (and presumably out-going members) of the Science Advisory Board have been active in the fields of environmental justice, benefit calculations for potential regulations on critical air constituents, calculations of risk exposures. As seen in the litigation over applicants to this Board, it is likely that new members in 2025 may have a significantly different political perspective reflecting different values of weighing costs versus benefits of potential environmental regulations.
On October 11, 2023, USEPA finalized new regulations for PFAS reporting and record-keeping under TSCA Rule 8(a)(7). Starting on November 13, 2023, manufacturers and importers of per- and polyfluoroalkyl substances (PFAS) must submit information dating back to January 1, 2011. Reporting entities must provide all “known or reasonably ascertainable” information related to chemical identity, uses, production volumes, byproducts, environmental and health effects, worker exposure, and disposal via the Central Data Exchange platform. Reporting requirements will be streamlined for PFAS used in research and development, and for those only importing PFAS contained in manufactured articles. Entities are must retain records for five years. This dataset will become the largest compilation of PFAS manufactured and used in the U.S.
In September 2024, USEPA announced a direct final rule that delays the start date of the reporting period to July 11, 2025, due to resource constraints. Manufacturers must complete reporting between July 11, 2025 and January 11, 2026. Small manufacturers reporting only on importing PFAS in articles have an additional 6-month window.
Additionally, on January 8, 2024, USEPA finalized a rule to prevent inactive PFAS from reentering commerce unless approved by USEPA. The rule applies to all PFAS designated as “inactive” on the TSCA Inventory and not already subject to a significant new use rule. In total, the rule affects 329 PFAS that now require USEPA notification and approval prior to use.
On January 9, 2024, USEPA announced the automatic addition of seven PFAS to the Toxics Release Inventory (TRI) list. Facilities in designated industry sectors and federal facilities that manufacture, process, or otherwise use TRI chemicals above set quantities are required to report data on the quantities of these chemicals released into the environment or managed as waste. The National Defense Authorization Act (NDAA) for Fiscal Year 2020 established a framework for adding PFAS to the TRI annually once USEPA finalizes final toxicity values for the compounds. So far, a total of 196 PFAS have been added. The seven PFAS added for the 2024 TRI Reporting Year are:
Data for the 2024 TRI Reporting Year are due to USEPA by July 1, 2025. All reported TRI data are available online and can be accessed by communities, government, non-government agencies and companies to learn how entities manage listed chemicals.
C. USEPA Proposes to List Nine PFAS as RCRA ‘Hazardous Constituents’
On February 8, 2024, USEPA published a Proposed Rule that would list the following nine PFAS, their salts and their structural isomers as hazardous constituents under the Resource Conservation and Recovery Act (RCRA). The nine PFAS are:
The Proposed Rule would allow USEPA and delegated states to pursue RCRA corrective actions, such as investigation and cleanup for these PFAS at hazardous waste treatment, storage, and disposal facilities. USEPA identified 1,740 facilities across industries that could be impacted by this rule. The Proposed Rule would not list PFAS as a RCRA hazardous waste under 40 CFR section 261.11(a)(3). At this time, the USEPA does not propose to make PFAS a RCRA-listed or characteristic waste.
Separately, USEPA published a Proposed Rule to “modify the definition of hazardous waste as it applies to cleanups at permitted hazardous waste facilities.” This rule would ensure that regulations reflect USEPA’s and authorized states’ authority to require cleanup of emerging chemicals of concern, such as PFAS, at permitted facilities.
In April 2024, the USEPA published the Final Human Health Toxicity Assessment for Perfluorooctanoic Acid (PFOA) and Related Salts and Final Human Health Toxicity Assessment for Perfluorooctane Sulfonic Acid (PFOS) and Related Salts. The assessments summarize toxicological knowledge from laboratory and human studies. The permissible dose of PFOA over a lifetime, known as a reference dose, was lowered to 3 x 10-8 milligrams per kilogram bodyweight per day. Similarly, the permissible dose of PFOS was lowered to 1 x 10-7 milligrams per kilogram bodyweight per day.
On April 10, 2024, USEPA finalized National Primary Drinking Water Regulations (NPDWR) for six PFAS:
The NPDWR set Maximum Contaminant Levels (MCLs) for these PFAS, considering the available treatment technologies and their costs. Individual MCLs were finalized for five PFAS, a Hazard Index MCL was finalized for four combined PFAS, and a health-based water concentration was established for four PFAS (Table 1).
Table 1. MCLs and Health-Based Concentrations for PFAS in Drinking Water
PFAS |
Individual MCL (parts per trillion) |
Hazard Index MCL (unitless) |
Health-Based Water Concentration (parts per trillion) |
PFOA |
4.0 |
- |
- |
PFOS |
4.0 |
- |
- |
PFHxS |
10 |
1 |
10 |
PFNA |
10 |
10 |
|
HFPO-DA (GenX Chemicals) |
10 |
10 |
|
PFBS |
- |
2,000 |
USEPA's Hazard Index uses individual measurements of PFNA, PFHxS, PFBS, and HFPO-DA to evaluate their combined hazard. Measurements of the four individual PFAS are divided by their respective health-based water concentrations, and summed to calculate a Hazard Index, which is compared to a Hazard Index MCL of 1. A Hazard Index greater than 1 is considered an MCL exceedance.
USEPA established practical quantitation levels (PQLs) for the regulated PFAS, which are the lowest levels at which constituents can be reliably quantified within specified limits of precision and accuracy during routine laboratory operating conditions. The PQLs for PFOA and PFOS were set at 4 ppt, equivalent to their MCLs. PQLs were also set at 3 ppt for PFHxS, 4 ppt for PFNA, 5 ppt for HFPO-DA, and 3 ppt for PFBS.
Public water systems must complete initial monitoring by 2027 and begin ongoing compliance monitoring thereafter. Beginning in 2027, public water systems must include PFAS monitoring data in Consumer Confidence Reports. Starting in 2029, if PFAS concentrations exceed the MCLs in drinking water, public water systems must take action to reduce levels and notify consumers. USEPA identified four Best Available Technologies for treating regulated PFAS: granular activated carbon, anion exchange, nanofiltration, and reverse osmosis. The estimated cost of PFAS monitoring and treatment for public water systems is $1.5 billion per year.
On April 19, 2024, USEPA designated PFOA and PFOS, including their salts and structural isomers, as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA, or Superfund).
CERCLA empowers government agencies and third parties to clean up sites impacted by hazardous substances and seek cost recovery from responsible parties, which could be required to cover the costs of the clean-up and provide alternative drinking water supplies, if necessary. Additionally, the designation of PFOA and PFOS as CERCLA hazardous substances allows for USEPA investigations and enforcement at new Superfund sites, reevaluation of remedies at active Superfund sites, and reopening of closed Superfund sites.
USEPA released a memorandum titled PFAS Enforcement Discretion and Settlement Policy Under CERCLA, outlining how the agency plans to exercise its enforcement discretion in CERLCA matters involving PFAS. The memorandum notes that USEPA will focus on holding entities responsible that “significantly contributed to the release of PFAS into the environment.” It also notes that USEPA does not intend to pursue entities where “equitable factors do not support seeking response actions or costs, such as public and community water systems and local fire departments.
The American Society for Testing and Materials Standard E1527-21 for Phase I environmental site assessments (ESAs) is approved by USEPA to satisfy the All Appropriate Inquiry Rule in order to qualify for certain CERCLA liability protections. A critical component of the Phase I ESA process is to identify Recognized Environmental Conditions (RECs) resulting from releases of CERCLA hazardous substances and petroleum products. With PFOA and PFOS now designated as hazardous substances, releases of these chemicals are now in-scope and must be considered, when identifying RECs as part of the Phase I ESA process.
A default reportable quantity of one pound has been established for PFOA and PFOS. Releases above one pound within a 24-hour period must be immediately reported to the National Response Center, unless the release is federally permitted. Additionally, facilities must immediately notify the appropriate State or Tribal Emergency Response Commission and local or tribal Emergency Planning Committees of a hazardous substance release.
On April 8, 2024, USEPA published interim guidance on the destruction and disposal of PFAS and materials containing PFAS. The guidance describes technologies for managing the destruction and disposal of PFAS-containing materials and recommended practices to minimize PFAS releases to the environment. Materials specified in the guidance include aqueous film-forming foam, soil and biosolids, textiles treated with PFAS, spent materials from water treatment, landfill leachate, and other PFAS containing waste streams from facilities.