Science and Technology Committee Report

EPA’s Science Advisory Board and Other Advisory Boards

A. Litigation: Suit Challenging the Selection and Composition of The Science Advisory Board and Related Clean Air Scientific Advisory Committee.

Even before Galileo Galilei boldly challenged then prevailing orthodoxy by daring to suggest that the earth revolved around the sun, science has been the subject of political criticism and attack. Today, these attacks take the form not of threats of excommunication (or worse), but rather litigation challenging even the revision of membership in the United States Environmental Protection Agency’s (EPA) Science Advisory Board (SAB). In Young v. EPA, a former member of the SAB during the Trump Administration sued the Agency, claiming that its new appointment of scientists to a Biden Administration’s reconstituted SAB and also its separate new appointments to the Clean Air Scientific Advisory Committee (Clean Air Advisory Committee) violated federal standards requiring fairness and balance. Mr. Young, a statistician who formerly worked for the pharmaceutical industry, argued that EPA’s newly reconstituted boards were “purged” of industry representatives and this made both the SAB and the Clean Air Advisory Committee unfair and imbalance. This lawsuit, while initiated in late 2021, saw two critical decisions from the trial judge in the District Court for the District of Columbia in 2022.

Stanley Young’s complaint rested on an obscure federal statute enacted in 1972, the Federal Advisory Committee Act (Advisory Act). The Advisory Act’s statutory findings recite a cautious approach to the burgeoning practice of appointing advisory committees and similar councils. The Congressional findings state that such boards can be useful in providing “diverse” viewpoints, but caution that the “need” for many such advisory committees was not reviewed. The findings counsel that committees should be kept “to the minimum” and formed only when necessary. EPA lists twenty-one separate federal advisory committees within its jurisdiction. EPA notes that over 700 individuals serve on EPA related advisory committees and states in its description of FACA that one of the statutory requirements is that: “Committee membership must be balanced by points of view.”

Young used this statutory baseboard to launch a broad attack on the Biden Administration’s efforts to reconstitute the SAB and a separate advisory group, the Clean Air Advisory Committee. Notably, Biden’s new EPA Administrator Regan dismissed all existing members of both the SAB and the Clean Air Advisory Committee in March 2021. The political nature of this process was not lost on the press, with at least one commentator referring to it as a “purge.” The Trump Administration under Administrator Pruitt acted similarly after assuming control of the EPA.

In August 2021 the Administrator announced new appointments to the SAB, some of who held co-appointments with various standing committees of the SAB, such as the Agricultural, Climate Science and other committees. Young was not selected for re-appointment on the reconstituted SAB. Co-plaintiff Louis Cox, who served on the SAB and the Clean Air Advisory Committee, was not selected for re-appointment to either advisory entity. Both individuals sued, claiming that EPA’s appointment process violated Section 5 of the Advisory Act, which requires that legislation forming an advisory committee must ensure that it be “fairly balanced in terms of the points of view represented.” The plaintiffs claimed that the new SAB and Clean Air Advisory Committee failed to meet this requirement, partly because each lacked industry representation.

Judge Kelly of the District Court for the District of Columbia rejected plaintiffs’ claims on two grounds. As to an initial motion for a preliminary injunction against EPA’s appointment process, Judge Kelly found that the plaintiffs failed to establish irreparable injury in not receiving an appointment. Judge Kelly then determined in a separate opinion that plaintiffs’ claims failed on the merits. Judge Kelly concluded that while the question of whether an appointment process complied with the Advisory Act was justiciable, the standard of what in fact constituted a “fair balance” in a particular appointment process is largely left to the Administrator’s discretion. In reaching his conclusion that this particular process satisfied the “fair balance” standard, Judge Kelly noted in particular the scientific and technical nature of these two advisory entities, and commented that they were not called upon to render broad policy-based decisions, but rather to conduct reviews, such as peer review of a proposed agency decision. Judge Kelly’s distinction seems sensible, though the potential impact of a peer review process on a decision of whether to regulate may strike some as a politics cloaked in the “neutrality” of science. Judge Kelly subsequently certified part of his decision on summary judgment as a partial final judgment, clearing the way for an appeal to the D.C. Circuit Court of Appeals.

B. Litigation: The Science Advisory Board’s Criticism of EPA on PFAS Health Advisories and Two Separate Suits.

In June 2022 EPA issued a new series of “health advisories” for four PFAS-related compounds. Two of the health advisories were termed “interim” and related to PFOA and PFOS. The levels recommended for individuals exposed to those two compounds in drinking water were “near zero and below EPA’s ability to detect at this time.” The other set of health advisories were termed final by the Agency and dealt with “perfluorobutane sulfonic acid and its potassium salt (PFBS) and for hexafluoropropylene oxide (HFPO) dimer acid and its ammonium salt (“Gen X” chemicals).” EPA cited its broad authority under the Safe Drinking Water Act to set these “advisories” which are not formal regulations. EPA’s statutory authority under the cited provision relates to unregulated contaminants, i.e., those not yet subject to a drinking water standard. EPA is required to consult with “the scientific community” including the SAB, as to listing such contaminants. And the decision to add a contaminant to EPA’s unregulated contaminant list is not subject to judicial review. This makes some sense because EPA is only authorized to promulgate an interim or final drinking water standard after listing on the unregulated contaminant list. EPA’s rulemaking determination is then subject to Administrative Procedure Act review.

Through the interim Heath Advisories for PFAS and PFOA, EPA set the lifetime safe exposure levels to ultra-low limits of 0.004 part per trillion (or 4 parts per quadrillion) for PFOA and .02 part per trillion for PFOS (or 20 parts per quadrillion). These levels are below existing standard laboratory detection limits and are at least two orders of magnitude below EPA’s initial Health Advisories, set in 2016, which were then set at 70 ppt.

EPA also set final health advisories for hexafluoropropylene oxide dimer acid and its ammonium salt (Gen X chemicals) and for perfluorobutane sulfonic acid and its related compound collectively referenced as PFBS. Those levels were set at 10 ppt and 2,000 ppt respectively.

Two lawsuits followed shortly thereafter, with the plaintiff in each claiming that EPA disregarded science in setting the health advisories. Both suits raise interesting and direct challenges to EPA’s scientific decision-making process based in part upon its alleged disregard of peer-review comments and the SAB process of review. In the first suit, a major manufacturer of PFAS compounds, The Chemours Company FC, LLC (Chemours), filed suit in the U.S. Court of Appeals for the Third Circuit challenging EPA’s health advisory for the Gen X chemicals. Chemours alleged that EPA’s advisory violated sound scientific methodology, noting that one of EPA’s own peer review members criticized the Agency’s reference dose calculation as “extreme” and “excessive.” In a second suit, the American Chemistry Council (Chemistry Council) challenged EPA’s interim Health Advisories as to PFAS and PFOA. The Chemistry Council’s petition specifically noted that the SAB’s PFAS Panel raised significant concerns in preliminary communications about EPA’s science supporting the new interim health advisories and, despite these concerns and an ongoing review by SAB, EPA rushed ahead with its “interim” health advisories for the two compounds.

After the filing of these suits, SAB issued a final report on a related PFAS set of issues involving the Agency’s proposed national standards for PFAS and related compounds in drinking water. In its report, SAB “applauded” EPA’s efforts to develop new risk approaches to these compounds, but found that “the supporting documents related to approaches for deriving the PFOA and PFOS MCLGs [Maximum Contaminant Level Goals] to have a number of methodological flaws.” The SAB noted a lack of clarity in EPA’s standard for evaluating risks posed by the compound in leaving unclear what exact methodology it used for making that assessment. This SAB report does not directly discuss EPA’s separate effort to set Health Advisory Levels, but expresses scientific skepticism over significant portions of the Agency’s current PFOA/PFAS risk assessment methodology.

In September 2022, EPA moved to dismiss both the Chemours case and the Chemistry Council case on the grounds that a health advisory standard has no regulatory effect and therefore is not subject to judicial review, which is limited to “final” agency action. EPA also moved to dismiss the two cases based upon lack of Article III standing. EPA avoided briefing the scientific merits of either set of health advisories, and instead, focused solely on the lack of a formal regulatory effect of the health advisories. On December 6, 2022, the Court of Appeals for the Third Circuit denied EPA’s motion to dismiss without further explanation. On January 23, 2023 the D.C. Circuit dismissed ACC’s petition on the grounds that it lacked standing. In addition, this challenge may yet be heard in another forum—that of one or more oversight committees in the next session of Congress, particularly in the newly constituted House of Representatives. Recently Congress has received detailed reports on potential regulation of PFAS and related compounds under a variety of laws, including EPA’s issuance of the June 2022 health advisories.

C. Regulatory: The Science Advisory Board and Environmental Justice

In December 2022, the SAB issued a final report urging EPA to develop a more systematic evaluation for environmental justice (EJ) impacts of the Agency’s air pollution regulations. SAB specifically addressed a proposed regulation to reduce emissions for heavy-duty trucks. SAB supported the direction of EPA’s regulatory effort (i.e., reduction of truck pollution), but urged EPA to adopt a more systematic approach to understand “community-scale” benefits (or lack thereof) in its air regulations. SAB noted that EPA’s current approach “precludes analysis of the environmental justice (EJ) benefits of emission reductions, particularly for traffic-related air pollutants. . . that exhibit strong spatial gradients.” The SAB stated that the draft is a “work in progress”, but it is consistent with comments received from other scientists on the proposed regulation.

The final report position indicates that scientists, including those on the SAB, continue to urge use of new technologies and updated epidemiological data to evaluate the impact of proposed regulations on disadvantaged communities. Scientists have an important role to play in the delivery of fair justice to all communities, and this SAB initiative is one welcome in instituting a more systematic regulatory review for EJ impacts.

Antimicrobial Pesticide Innovation and Enforcement – Post-Pandemic Legacy

A. Introduction

This past year fortunately saw the waning of the COVID-19 pandemic, which had ushered in unprecedented demand for traditional and innovative antimicrobial products. A pandemic related paradigm shift in cleaning and disinfecting protocols for office and industrial settings, as well as homes, continues with rigorous return-to-work programs being developed and implemented. The pandemic also presented regulators with significant challenges of enforcing pesticide regulations amidst workforce constraints, surges in the demand for product registrations, and the production and import of antimicrobial products. Additionally, pesticide devices, which do not require registration with the EPA prior to market introduction, have been at the forefront of enforcement priorities for EPA -- particularly devices that make claims related to microbes such as viruses. As 2022 progressed, two critical antimicrobial product issues related to the pandemic response and enforcement saw significant activity: (1) growth for innovative antimicrobial products with EPA finalizing its “Guidance for Products Adding Residual Efficacy Claims,” and (2) the continued evolution of antimicrobial pesticide device enforcement and standards.

B. EPA Guidance for Products Adding Residual Efficacy Claims

Antimicrobial disinfectant pesticides are designed to kill bacteria and viruses present on surfaces at the time the product is applied -- colloquially known as a “wet kill.” As part of EPA’s early response to the COVID-19 pandemic, EPA created “List N” -- a list of registered disinfectants for use against SARS-CoV-2, the virus that causes COVID-19. Until April 2021, EPA also expedited the review of applications for disinfectant products intended for use against SARS-CoV-2.

An additional pandemic response step was initiated by EPA in October 2020 with draft guidance that focused on antimicrobial products with residual efficacy claims. Surficial treatment with residual antimicrobial products can kill bacteria and viruses for days or weeks after application. It is important to note that these types of products are broadly considered as supplements to registered disinfectants and for use as added protection to routine cleaning and disinfection programs.

A key development in 2022 was the issuance of the final “Guidance for Products Adding Residual Efficacy Claims.” An appendix to List N, colloquially known as “List N.1,” was established by EPA for supplemental residual antimicrobial products that can be used against SARS-CoV-2. As of December 2022, only two paint products have been added to List N.1.

The “Guidance for Products Adding Residual Efficacy Claims” establishes the registration framework and testing requirements for antimicrobial residual efficacy claims, which can be made for two categories of products:

• Residual disinfectants (the product must first meet the standard for disinfection efficacy before a residual efficacy claim can be considered). These products are limited to a 24-hour duration residual efficacy claim.
• Supplemental residual products that do not meet the criteria for registration as a disinfectant but are intended for use as a supplement to standard disinfection. This includes two general categories of products: 1) coatings and films, and 2) fixed/solid surfaces including solid copper, other metals and solid impregnated materials, and paints. Residual efficacy claims of weeks to years may be made for this category of product based on testing results.

Meeting the criteria for residual antimicrobial efficacy claims involves complex testing and product formulation challenges that can take time and is challenging for novel product formulations outside of traditional liquid matrices. The guidance specifies criteria that must be met to make residual claims as well as specific bacteria and virus types for testing and test guidelines to be followed. Claims are only permitted for products used on hard, non-porous, non-food contact surfaces. Criteria to be assessed and for which standards have been established for each product category include: duration of residual claim; durability of the product subject to abrasion and a combination of chemical and abrasion challenges; efficacy against bacteria based on log reduction; efficacy against viruses based on log reduction; and the amount of time to meet the efficacy performance standard. Claims for treatment against viruses may only be made if the product has already met the efficacy standard established for bacteria. The guidance also specifies labeling claims, limitations, and use instructions associated with each category of residual product, particularly for supplemental residual products. EPA also requires, as a condition of registration, that registrants of all supplemental residual products prepare and implement a written stewardship plan to support the responsible use of these products.

In the wake of the COVID-19 pandemic, development and use of innovative products that kill bacteria and viruses on surfaces not only upon application, but for weeks or years thereafter, offers the potential for significant public health benefits. The effectiveness and efficiency of residual efficacy claims registrations and label updates based on the now final guidance will warrant watching in 2023.

C. Antimicrobial Device Enforcement and Standards Evolution

Pesticide devices are instruments or contrivances (other than a firearm) that are used to destroy, repel, trap or mitigate any pest such as insects, weeds, rodents, certain other animals, birds, mold/mildew, bacteria, and viruses. A pesticide device does not rely on a chemical or substance (i.e., active ingredient), but works by physical means (such as electricity, light or mechanics) to perform its intended pesticidal purpose. Due to concerns around rapid growth in the introduction of antimicrobial products during the pandemic and potentially false or misleading claims related to efficacy against SARS-CoV-2, EPA issued several Compliance Advisories and notices on its website in 2020 and 2021. This increased EPA scrutiny has particularly fallen on antimicrobial devices such as air purifiers, water filters, and UV lights, which do not require registration or claims review prior to market introduction.

According to the “Device Efficacy” section of Chapter 13, Devices of EPA’s Pesticide Registration Manual: “FIFRA does not require device producers to submit any data concerning either safety or efficacy of a device prior to distribution or sale.” It is also stated that,

[t]he device may be ‘misbranded’ if labels, labeling, and/or websites for devices including general or specific efficacy claims include any statement, design, or graphic representation that is ‘false or misleading in any particular’…Therefore, every producer or seller of devices is responsible for ensuring that these products perform as claimed, and that such performance claims are not misleading to the intended user.

However, while substantiation of efficacy claims is required to be available from device producers there are no promulgated regulations or guidelines requiring specific types of efficacy studies or test methods​.

With its increased scrutiny of antimicrobial pesticide devices over the past couple years, particularly on unqualified antimicrobial claims and supporting efficacy data, EPA has moved into what appears to be a regulatory gray area where judgments are being made on types and sufficiency of data required to support antimicrobial devices’ efficacy claims. This enforcement focus however, is occurring in the absence of any guidance from EPA. Device manufacturers must make individual determinations on which tests to run – and then hope the testing is sufficient to prove compliance with the evolving landscape on supporting data and claims.

EPA has acknowledged that the pandemic exposed many challenges in regulating antimicrobial pesticide devices and that the current framework does not address the complexity of the devices on the market today. It has also recognized a need to revise the way devices are regulated and is seeking stakeholder input for rulemaking with a focus on efficacy test standards and claims. Until such changes occur, antimicrobial device manufacturers and importers should carefully evaluate device efficacy claims and supporting data against the current environment of increased scrutiny and evolving data standards.