EPA Issues Stop Sale Order for COVID-19 Disinfectant
By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
On July 8, 2021, U.S. EPA issued a Stop Sale, Use or Removal Order (SSURO) for SurfaceWise2, one of only two “durable” disinfectants that had been previously approved for emergency use. In August 2020, U.S. EPA issued the first ever Federal Insecticide, Fungicide and Rodentcide Act (FIFRA) public health emergency waiver for a surface disinfectant, approving SurfaceWise2 for use on surfaces when used as a supplement to a “List N” disinfectant in Arkansas, Oklahoma, and Texas. Various environmental groups had challenged U.S. EPA’s emergency waiver over concerns that long-term exposure to SurfaceWise2’s active ingredient, quaternary ammonium, could have potential adverse human health effects.
According to the press related that accompanied the SSURO, U.S. EPA claims that Allied BioScience, the manufacturer of SurfaceWise2, was marketing and selling, and distributing Surfacewise2 in a manner that was inconsistent with the terms and conditions of the FIFRA emergency authorization. The SSURA requires Allied BioSciences to immediately stop selling and distributing SurfaceWise2 and will remain in effect unless revoked, terminated, suspended or modified in writing by U.S. EPA
Details regarding the alleged misconduct were not provided by U.S. EPA but according to a statement from Larry Starfield, U.S. EPA’s acting assistant administrator for the Office of Enforcement and Compliance Assurance, “Pesticides can cause serious harm to human health and the environment, which is why EPA requires their registration before being distributed for use” and “EPA is committed to holding companies accountable for not adhering to federal environmental laws.” U.S. EPA’s issuance of the SSURO for SurfaceWise2 coupled its issuance of other SSUROs in connection with the sale of unregistered products making COVID-19 efficacy claims demonstrates that U.S. EPA is continuing to aggressively enforce compliance with FIFRA rules and regulations regarding pesticide products and especially pesticide products making efficacy claims with respect to COVID-19.
Industry Organization Challenges EPA Cross State Air Pollution Rule
By Allison A. Torrence
As the saying goes, “no good neighbor rule goes unpunished.” Thus, the latest attempt by the U.S. Environmental Protection Agency (“EPA”) to promulgate a Revised Cross-State Air Pollution Rule (“CSAPR”) Update under the “good neighbor provision” of the Clean Air Act and in response to the D.C. Circuit’s remand of the previous version of the CSAPR Update has been challenged in court. On June 25, 2021, Midwest Ozone Group—an affiliation of companies, trade organizations, and associations created to advance its members interests regarding national ambient air quality programs—filed a petition for review of the final rule of EPA published in the Federal Register at 86 Fed. Reg. 23,054 (April 30, 2021) entitled the “Revised Cross-State Air Pollution Rule Update for the 2008 Ozone NAAQS.” The petition does not provide any details at this point regarding the basis for the group’s challenge to the Revised CSAPR Update.
As we previously reported on this Blog, the Revised CSAPR Update became effective 60 days after it was published (effective on June 29, 2021), and has requirements that begin right away in the 2021 ozone season (the ozone season is May 1 through September 30). The rule requires additional emissions reductions of nitrogen oxides (“NOX”) from power plants in 12 states: Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, Virginia, and West Virginia. EPA determined that additional emissions reductions were necessary in these 12 states because projected 2021 ozone season NOX emissions from these states were found to significantly contribute to downwind states’ nonattainment and/or maintenance problems for the 2008 ozone National Ambient Air Quality Standards (“NAAQS”). NOX is an ozone precursor, which can react with other ozone precursors in the atmosphere to create ground-level ozone pollution (a/k/a smog). These pollutants can travel great distances, often crossing state lines and making it difficult for downwind states to meet or maintain the ozone NAAQS.
One part of the Revised CSAPR Update that may be of particular interest to the challengers is that EPA issued new or amended Federal Implementation Plans (“FIPs”) for these 12 states that replaces those states’ existing CSAPR emissions budgets for power plants. The revised emission budgets take effect immediately with the 2021 ozone season and will adjust through 2024. The 2021 emission budgets will require power plants in these states to take advantage of existing, already-installed selective catalytic reduction (“SCR”) and selective non-catalytic reduction (“SNCR”) controls. Emissions reductions in the 2022 budgets will require installation or upgrade of state-of-the-art NOX combustion controls at power plants. Emission budgets will continue to be adjusted, through 2024, until air quality projections demonstrate that the upwind states are no longer significantly contributing to downwind states’ nonattainment of the 2008 ozone NAAQS.
Midwest Ozone Group is required to submit a Statement of Issues to be Raised by July 28, 2021, which should shed more light on the strengths or weaknesses of the petitioner’s challenges to this rule. Stay tuned to the Corporate Environmental Lawyer Blog for additional analysis at that time and if any other significant developments arise in the meantime.
EPA to Revise or Replace Trump-Era Clean Water Act Rules, But Will Leave Existing Rules In Place For Now
By Allison A. Torrence
The U.S. Environmental Protection Agency (“EPA”), under Administrator Michael Regan, has begun the process of reviewing and revising two key Clean Water Act (“CWA”) rules: The Navigable Waters Protection Rule and the CWA Section 401 Certification Rule. In recent court filings in cases where litigants have challenged both of these Trump-era rules, EPA has requested those cases be remanded because EPA has commenced new rulemaking processes that will revise or replace the challenged rules. However, if the courts grant EPA’s requests, EPA has requested that the existing rules remain in effect until EPA finalizes replacement rules through the formal notice and comment rulemaking process.
The first of the two key CWA rules at issue is the Navigable Waters Protection Rule, which defines “Waters of the United States”. This is a significant rule and definition because the jurisdiction of the CWA is limited to Waters of the United States. Thus, by setting the definition of Waters of the United States, EPA establishes the reach of the CWA. Due to the significance of this definition, it has been widely contested throughout the years and every attempt by EPA and the U.S. Army Corps of Engineers to promulgate a definition has faced legal challenges.
In 2019, the Trump Administration rescinded the Obama-era Waters of the United States rule and in 2020, issued the Navigable Waters Protection Rule, narrowing the definition of Waters of the United States. The most significant change in the Trump rule is that the new definition excludes ephemeral waters (those flowing only in direct response to precipitation) and many wetlands that are near other jurisdictional waters but lack a physical or surface connection to them.
In several court filings in June, EPA has stated its plans “to commence a new rulemaking to revise or replace the [Navigable Waters Protection] rule.” Notably, EPA is not requesting vacatur of the existing rule during the rulemaking process.
The second CWA rule facing a similar fate is the CWA Section 401 Certification Rule. Under the CWA, a federal agency may not issue a permit or license for an activity that may result in a discharge into a Water of the United States unless a Section 401 Certification has been issued verifying compliance with water quality requirements. States and authorized tribes are generally responsible for issuing Section 401 Certifications, and they are required to act on a Section 401 Certification request “within a reasonable period of time (which shall not to exceed one year) after receipt” of such a request. 33 U.S.C. § 1341(a)(1).
The Trump EPA issued the final CWA Section 401 Certification Rule on July 13, 2020, with the goal of expediting infrastructure permitting by making the 401 Certification process quicker. The biggest changes made by this rule were limiting the scope of state and tribal certification review and limiting the imposition of conditions in the certifications. Just as with the Navigable Waters Protection Rule, EPA has now indicated in court filings (and on its website) that the Section 401 Certification Rule is under review and will be revised or revoked, but also will not be vacated in the interim.
EPA has a lot of work ahead to propose new versions of these rules for public review and comment. Promulgation of final rules will therefore be many months, if not more than a year away. In the meantime, environmental groups and other challengers have indicated they will continue to challenge the Trump-era rules still in effect. The Corporate Environmental Lawyer blog will keep a close watch and report on all key developments.
OSHA’s Healthcare Emergency Temporary Standard Is Promulgated: The Countdown to a Legal Challenge Begins
By Gabrielle Sigel, Co-Chair, Environmental and Workplace Health and Safety Law Practice
On June 21, 2021, the federal Occupational Safety and Health Administration (OSHA) had its Occupational Exposure to COVID-19, Emergency Temporary Standard (ETS) published in the Federal Register, making it immediately effective on that date. 86 FR 32377 (June 21, 2021). OSHA has the authority to issue an ETS, for immediate application upon publication in the Federal Register, without first proceeding through typical notice-and-comment rulemaking, if OSHA “determines” that “employees are exposed to grave danger from exposure to substances or agents determined to be toxic or physically harmful or from new hazards,” and an ETS is “necessary to protect employees from such danger.” 29 USC §655(c)(1).
Any person “adversely affected” by the ETS may raise a legal challenge in the U.S. Court of Appeals of their principal place of business or residence, within 60 days after the ETS’s publication, and the court could then issue a stay of the rule’s implementation. 29 USC §655(f)(1). By statute, the “determinations of [OSHA] shall be conclusive if supported by substantial evidence in the record considered as a whole.” Id. OSHA has not successfully issued an ETS in more than four decades; the open legal issue is whether OSHA’s ETS will survive legal challenge, if any is raised.
Despite its broad title in the Federal Register, the ETS, to be codified at 29 CFR §1910.502, is targeted to specific employment “settings,” i.e., “all settings where any employee provides healthcare services or healthcare support services.” 29 CFR §1910.502(a)(1). OSHA further narrows the scope of the ETS to apply to those employees who are licensed healthcare providers and likely to be involved in the care of people suspected or confirmed to have COVID-19 and certain fully vaccinated employees. See generally, id. at §1910.502(a)(2) and the OSHA decision tree “Is Your Workplace Covered by the ETS?” The ETS requires that affected employers (1) have a COVID-19 plan, typically in writing, with a designated person in charge of implementing the plan, and based on a risk assessment, providing policies and procedures for control of COVID-19 transmission; (2) institute patient screening and management; (3) implement policies and procedures for precautions, including regarding PPE, response to aerosol-generating procedures, cleaning/disinfecting, physical distancing, and barriers; (4) ventilation standards; (5) have health screening and paid medical removal of employees after illness and exposure; (6) have paid vaccination leave; (7) provide training and communication, including regarding anti-retaliation protections; (8) institute recordkeeping of all COVID-19 cases, regardless of work-relatedness; and (9) institute a “mini respiratory protection program” when use of respirators are not otherwise required, but the employee or employer chooses to upgrade a facemask to an N95 or similar respirator. Employers must comply with all provisions within 14 days, i.e., by July 5, 2021, except for the provisions regarding physical barriers, training, and ventilation, which have a July 21, 2021 compliance date.
The ETS is accompanied by a preamble of more than 200 pages, much of it devoted to OSHA’s determinations regarding the grave danger and need for the ETS generally and each provision specifically. In the preamble, OSHA recognizes and addresses the most likely legal challenges to the ETS. OSHA begins by framing the ETS as an action which OSHA was required to take, because the OSH Act provides that OSHA “shall provide… for an emergency temporary standard” upon a finding of grave danger and need for the ETS. 29 USC §655(c)(1); 86 FR at 32380.
With respect to the grave danger element, OSHA’s position is that it need only show that the dangers to workers from COVID-19 are “incurable, permanent, or fatal…as opposed to easily curable and fleeting effects on their health.” 86 FR at 23280 quoting Fla. Peach Growers Ass'n, Inc. v. U.S. Dep't of Labor, 489 F.2d 120, 132 (5th Cir. 1974). OSHA begins by discussing the nature of the disease, including its health and “other adverse effects”, including “observed disparities in risk based on race and ethnicity,” and continues by addressing the transmission of the virus and the effect of vaccines on OSHA’s determination of grave danger, the effect on healthcare workplaces in particular. 86 FR at 32381, et seq. OSHA finds that “the advent of vaccines does not eliminate the grave danger …in healthcare workplaces where less than 100% of the workforce is fully vaccinated,” due to spread among unvaccinated workers, the risk of breakthrough infection among the vaccinated, and vaccine hesitancy among health care workers. Id. at 32398. OSHA hedges that ‘[i]f and when OSHA finds a grave danger from the virus no longer exists for the covered workforce (or some portion thereof), or new information indicates a change in measures necessary to address the grave danger, OSHA will update the ETS, as appropriate.” Id. at 32399. In the meantime, relying on “CDC guidance and the best available evidence, OSHA finds a grave danger in healthcare for vaccinated and unvaccinated HCP involved in the treatment of COVID-19 patients.” Id.
Reflecting that OSHA’s last attempt at issuing an ETS was rejected by the court for failure to show the necessity of the rule, given already existing OSHA standard, OSHA spent most of the preamble addressing the necessity issue. See Asbestos Info. Ass'n/N. Am. v. OSHA, 727 F.2d 415, 425-26 (5th Cir. 1984). In this case, the necessity element is particularly difficult for OSHA to establish, including because of its own prior response to COVID-19 in the workplace. OSHA notes that since January 2020 and continuing through October 2020, it has received requests for an ETS. However, beginning in May 2020, OSHA rejected those attempts given its existing enforcement tools, including for PPE, respiratory protection, and the General Duty Clause. When sued by the AFL-CIO for failing to issue a COVID-19 ETS for all workers, the U.S. Court of Appeals for the D.C. Circuit found that “in light of the unprecedented nature of the COVID-19 pandemic, as well as the regulatory tools that the OSHA has at its disposal to ensure that employers are maintaining hazard-free work environments, …OSHA reasonably determined that an ETS is not necessary at this time.” In re Am. Fed'n of Labor & Cong. of Indus. Orgs., No. 20-1158, 2020 WL 3125324 (D.C. Cir., June 11, 2020).
OSHA recognizes that, after it decided against issuing an ETS, some state and local governments issued their own requirements and guidelines, leading to a “patchwork of state and local regulations [providing] inadequate and varying levels of protection for workers across the country, and [causing] problems for many employees and businesses.” Id. at 32413. Thus, OSHA “does not believe its prior approach—enforcement of existing standards and the General Duty Clause coupled with the issuance of nonbinding guidance—has proven over time to be adequate to ‘reduce the risk that workers may contract COVID-19’ in healthcare settings.” Id.
To support this decision, OSHA critiques the inadequacy of several tools it has already used for its COVID-19 enforcement efforts, including its main weapon—the General Duty Clause. See, e.g., id. at 32415, et seq. OSHA finds several weaknesses in the use of the General Duty Clause, including because it imposes a “heavy litigation burden on OSHA.” OSHA would have to prove that the COVID-19 infection hazard was present at the particular workplace that was cited and that each abatement method that OSHA recommends would materially reduce the hazard at that particular workplace. Moreover, OSHA admits that it could not use the General Duty Clause to enforce the ETS’s requirements for paid time for vaccination, its side effects, and medical removal. Id. at 32420. OSHA also notes that an ETS is necessary for it to address willful violations of the law by clarifying “what exactly employers are required to do to protect employees,” implying that the General Duty Clause does not do so. Id. at 32420. OSHA notes that the Clause is further limiting because it would not permit it to cite the employer on a “per-instance basis” for each employee that OSHA determines was not adequately protected. OSHA also critiques the General Duty Clause for its “limited application to multi-employer worksites, like hospitals,” thus giving OSHA the ability to, for example, cite the hospital for exposing a non-employee to a COVID-19 hazard. Id. at 32420-21.
OSHA also critiques the efficacy of its voluntary guidance for protecting workers, including the lack of compliance and the need for a “more consistent national approach,” that “levels the playing field” among all employers. Id. at 32422. OSHA proceeds to show that its previous reasons for rejecting an ETS, issued “at an early phase of the pandemic,” do not preclude OSHA’s action now. The agency agrees with criticism, including that issued by the Department of Labor’s Office of Inspector General, that “the combination of guidance and General Duty Clause authority has done little to protect employees [and] will not protect employees covered by this ETS….” Id. at 32423. OSHA also rejects that availability of vaccines has made the ETS unnecessary, and finds that “the potential for higher immunity rates later on does not obviate the need to implement the ETS now.” Id. at 32424. OSHA’s position reflects that although the ETS is immediately effective, OSHA must now open a notice-and-comment procedure and either issue a permanent standard according to those methods within 6 months, or the ETS is no longer applicable. 29 USC §655(c)(3).
OSHA’s justification for the ETS is hampered by both a lack of data and evolving data. OSHA admits that it does not have the data to conduct its typical risk assessment, and that it cannot state the number of healthcare workers that have contracted COVID-19. OSHA asserts that such an assessment “is not necessary in this situation” because the
“gravity of the danger presented by a disease with acute effects like COVID-19…is made obvious by a straightforward count of deaths and illnesses….” Id. at 32411. OSHA estimates that the ETS will save 776 lives over the next 6 months, based on a seven-step estimating process, which OSHA also modifies in certain circumstances. 86 FR at 32537.
OSHA also has the data-based challenges of declining infections, hospitalizations, and death; the lack of data that any state-promulgated ETS had any effect on work-related transmission of the virus; declining worker complaints about COVID-19 related hazards; and the paucity of data showing that healthcare workers face greater risks at work than in the community at large. In addition, while declaring that its current enforcement methods are not effective, OSHA has sparse data showing that is the case. The Department of Labor’s Office of Inspector General found that it was OSHA’s tepid enforcement in 2020 that led to greater COVID-19 hazards in the workplace, and OSHA’s March 2021 National Emphasis Program addressing COVID-19 has barely gotten off the ground. Moreover, none of the agency’s COVID-19 General Duty clause cases have reached the point of decision by the Occupational Safety and Health Review Commission, which would indicate whether OSHA could effectively rely on the General Duty Clause, including as a deterrent to other employers who have not been cited.
The time clock for a legal challenge to the ETS has started. If challenged, OSHA must show that its preamble provides “substantial evidence” such that “a reasonable mind might accept [it] as adequate to support a conclusion.” American Textile Mfrs. Inst., Inc. v. Donovan, 452 U.S. 490, 522 (1981). As the court noted in Asbestos Info. Ass'n, this standard requires that the court “take a ‘harder look’ at OSHA’s action than we would if we were reviewing the action under the more deferential arbitrary and capricious standard applicable to agencies governed by the Administrative Procedure Act.” 727 F.2d at 421. To protect the ETS from legal challenge, OSHA has included a severability clause in the regulation itself, stating that “each individual section and provision of the ETS can continue to sensibly function in the event that some sections or provisions are invalidated, stayed, or enjoined.” 86 FR at 32617. Whether this COVID-19 Healthcare ETS becomes OSHA’s first emergency rule in more than 40 years is now an active question, including whether there are parties who wish to take the public position of opposing protections for health care workers during a pandemic.
For information or advice on OSHA guidance, standards and enforcement during the pandemic, please contact the author. Additional information regarding working during the COVID-19 pandemic can be found in Jenner & Block’s Corporate Environmental Lawyer blog and in the Jenner & Block COVID-19 Resource Center.
OSHA’s Updated COVID-19 Workplace Safety Guidance: Now Employers Have the Hard Part
By Gabrielle Sigel, Co-Chair, Environmental and Workplace Health and Safety Law Practice
On June 10, 2021, the US Occupational Safety and Health Administration (OSHA) published its long-awaited response to President’s Biden’s January 21, 2021 Executive Order to OSHA, which had directed the agency to consider and, if necessary, by March 15, 2021, issue an Emergency Temporary Standard (ETS) in response to workplace hazards from COVID-19. With the deadline long-passed, interest in OSHA’s approach was heightened when the CDC, on May 13, 2021, issued its Interim Public Health Recommendations for Fully Vaccinated People (the “May 13 CDC Guidance”), and OSHA posted on its website that it was updating its guidance in response.
As the author predicted, OSHA did not issue a broad COVID-19 ETS applicable to all industries. Instead, on June 10, 2021, OSHA issued two documents: (1) an ETS applicable only to the healthcare industry; and (2) updated guidance applicable to all other industries, implementing the recommendations from the May 13 CDC Guidance. This article addresses only the updated guidance.
The June 10, 2021 OSHA guidance, “Protecting Workers: Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace” (“Updated OSHA Guidance”) replaces guidance of the same name that the agency issued on January 29, 2021. The difference between the two versions of OSHA’s guidance reflects the significant changes that have occurred in disease transmission and workplace risks, due to vaccines and other factors. Because the May 13 CDC Guidance found that most “fully vaccinated people can resume activities without wearing a mask or physically distancing” in most locations, the Updated OSHA Guidance announced: “Unless otherwise required by federal, state, local, tribal, or territorial laws, rules, and regulations, most employers no longer need to take steps to protect their fully vaccinated workers who are not otherwise at-risk from COVID-19 exposure” (emphasis removed). Therefore, the Updated OSHA Guidance “focuses only on protecting unvaccinated or otherwise at-risk workers in their workplaces (or well-defined portions of workplaces).” “At-risk workers” are defined as those (a) whose medical condition are such that they may not “have a full immune response to vaccination,” or (b) who, under the Americans with Disabilities Act, “may be legally entitled to reasonable accommodations that protect them from the risk of contracting COVID-19 if, for example, they cannot be protected through vaccination, cannot get vaccinated, or cannot use face coverings.”
With publication of the Updated OSHA Guidance, the agency clearly is pulling back from regulating COVID-19 in most workplaces, particularly compared to its stance earlier this year. As is typical, OSHA advises that its guidance “is not a standard or regulation, and it creates no new legal obligations.” Also, as typical, the guidance has a subtext that its guidance could be used to establish a recognized hazard and methods of prevention under the OSH Act’s General Duty Clause. Yet, by issuing guidance, rather than regulation, OSHA is signaling that its concerns about risks from COVID-19 in most workplaces have significantly decreased since vaccines have become widely available.
In the Updated OSHA Guidance, it advises that both at-risk workers and other unvaccinated workers (collectively, “protected workers”) should be protected from the risks of COVID-19 in the workplace. The Updated OSHA Guidance proceeds to describe control measures that an employer “should take” to protect these workers in all industries except healthcare (who are covered by the new ETS); public transportation (workers are subject to CDC’s transportation-related mask mandate); and schools (which are to follow “applicable,” but unspecified, CDC guidance).
With respect to recommended protections, OSHA provides a two-part approach. Part one describes controls for all workplaces, and part two is an “Appendix” with “Measures Appropriate for Higher Risk Workplaces with Mixed-Vaccination Status Workers.” In part one, OSHA recommends 11 “multi-layered interventions” that “employers should engage with workers and their representatives to determine how to implement” for protected workers:
- Grant paid time off for vaccination.
- Sick or symptomatic employees, and protected workers who were exposed as “close contacts” should stay home.
- Physical distancing in all communal areas, particularly indoors, and use barriers when distancing is not possible.
- Provide, at employer’s cost, CDC-compliant face coverings or surgical masks to protected workers, for indoor work. All but immunocompromised workers can opt for no mask-wearing outdoors. Employers can determine that PPE, e., respirators, are necessary for protected workers, including when PPE is a “reasonable accommodation” under the ADA. In addition, if workers “want to use PPE if they are still concerned about their personal safety (e.g., if a family member is at higher-risk for severe illness,” employers should “[e]ncourage and support voluntary use of PPE in these circumstances and ensure the equipment is adequate to protect the worker.” However, if face coverings present greater risk, e.g., from heat-related illness, the employer should develop other face covering/respirator options.
- Educate and train workers on COVID-19, controls (including vaccination), and workplace policies, and track that training “as appropriate.” “Ensure” that supervisors are familiar with the employer’s “workplace flexibilities and other human resources policies and procedures,” and that all workers understand their rights.
- “Suggest that unvaccinated customers, visitors, or guests wear face coverings,” in workplaces where there are public interactions with protected workers, “even if no longer required by your jurisdiction.”
- Maintain ventilation systems, per CDC and ASHRAE guidance, including installing air filters at a minimum of MERV 13.
- Routinely clean and disinfect if someone with COVID-19 symptoms or diagnosis was in the worksite within the past 24 hours, in accordance with OSHA standards for use of cleaning chemicals.
- Record and report COVID-19 infections/deaths per 29 CFR part 1904, but through May 2022, OSHA is not requiring that adverse reactions to a mandated vaccine be recorded as a work-related illness.
- Protect workers from retaliation and establish an anonymous process for voicing concerns.
- Follow OSHA standards on PPE, sanitation, and other potentially applicable regulations, as well as an employer’s obligations under the General Duty Clause.
In the Appendix, OSHA recommends that employers assess whether their protected workers are at greater risk, by evaluating close contact situations, duration of contacts, type of contacts, and “distinctive factors” such as employer-provided transport, community exposure, and communal housing and living quarters, particularly in manufacturing, meat and poultry processing, high-volume retail and grocery, and seafood processing. In those workplaces, employers should evaluate imposing additional protections for protected workers, such as physical distancing, staggered work schedules, ventilation improvements, and barriers.
Although OSHA urges employers to impose a separate set of obligations solely for a subset of workers, OSHA is silent on several issues of importance to an employer managing its workplace during this “vaccine-available” phase of the pandemic. Instead, it is up to employers to determine how to navigate the public health, safety, and equal opportunity employment law, and other legal constraints to implement those issues at their workplaces. For example, OSHA is silent on:
- An employer’s methods for identifying or verifying which of its workers are vaccinated and, therefore, no longer need to be protected from COVID-19 hazards.
- Whether there are any non-excepted industries where there should be protections for vaccinated workers, who are not known to be at-risk, but who may still get symptoms or test positive for COVID-19 because, as CDC has said: “How long vaccine protection lasts and how much vaccines protect against emerging SARS-CoV-2 variants are still under investigation.” However, vaccinated workers are indirectly addressed when OSHA states that “all workers should be supported in continuing face covering use if they choose, especially in order to safely work closely with other people.”
- Whether those who contracted COVID-19 over the past 90 days, but are not vaccinated, can be treated as vaccinated workers. (Note: CDC guidance states that people who recovered from COVID-19 do not need to quarantine after exposure to another COVID-19 case.)
- OSHA’s Appendix does not emphasize PPE, such as N95 respirators, even for voluntary use, and even at the higher-risk workplaces.
- The Updated OSHA Guidance does not refer to the agency’s March 12, 2021 COVID-19 National Emphasis Program or enforcement protocols.
The Updated OSHA Guidance no longer (or only briefly) discusses several topics that were discussed at length in the January 29, 2021 OSHA guidance. For example, the old guidance instructed employers to “Not distinguish between workers who are vaccinated and those who are not.” The Updated OSHA Guidance instructs the opposite. The Updated OSHA Guidance also:
- No longer addresses the need to assign a workplace coordinator for COVID-19 or to conduct a “thorough hazard assessment”.
- No longer recommends an extensive and enhanced cleaning and disinfection process.
- No longer addresses screening and testing.
- No longer provides extensive instructions regarding “good hygiene practices,” including hand washing and sanitizers.
- No longer states detailed recommendations on isolation, quarantine, contact tracing, and return to work protocols. Instead, OSHA now encourages employers to report COVID-19 cases as required locally and to support local contact tracing efforts, and to have all ill workers stay home, but does so in far less detail.
Throughout the pandemic, employers have been looking to the CDC and OSHA, as well as the EEOC, for guidance on the steps they should take to protect workers and to avoid liability to their workers, the government, and the public. Particularly now that state and local governments have eliminated all or most COVID-19 restrictions, employers seeking to limit their liabilities will have the difficult task of developing different ways to work now that their employees can, and according to OSHA, should be divided into two populations: the vaccinated worker and the protected worker. The Updated OSHA Guidance describes how the protected worker should be treated differently, but the employer has the more difficult challenge of adapting that guidance to the business’s unique culture, financial constraints, and goals for survival and success, during yet another unprecedented phase of working in a pandemic.
For more information or advice on the OSHA standards and enforcement during the pandemic, please contact the author. Additional information regarding working during the COVID-19 pandemic can be found in Jenner & Block’s Corporate Environmental Lawyer blog and in the Jenner & Block COVID-19 Resource Center.
Analysis of Recent and Forthcoming State Legislation on Toxic Chemicals in Cosmetics and Personal Care Products and Preemptive Effects of Existing Federal Legislation
By Matthew G. Lawson
According to a report released in February 2021 by the organization Safer States, at least 27 US states will consider proposed legislation to regulate toxic chemicals in 2021. While a large driver of the proposed state laws is growing public concern over drinking water contamination from “emerging contaminants,” including PFAS (per- and polyfluorinated alkyl substances) and 1,4-dioxane, a secondary focus has been to minimize the risk of adverse human health effects from exposure to these toxic chemicals in cosmetics and personal care products. Two states—New York and California—are spearheading these efforts through recently enacted laws to limit or prohibit certain toxic chemicals in cosmetics and personal care products that are set to take effect in 2022 and 2025, respectively. As other states consider their own bills to enact similar regulation of chemicals in cosmetics and personal care products, heightened attention will likely be paid to what extent the existing federal regulation of these products may preempt this new wave of state legislation.
- Federal Regulation of Chemicals in Cosmetics and Personal Care Products
At the federal level, chemicals used in cosmetics and other personal care products are primarily regulated by either the Toxic Substrates Control Act (TSCA) or the Federal Food, Drug, and Cosmetic Act (FD&C Act). While TSCA broadly applies to any “chemical substance,” certain chemicals or uses of chemicals are exempt from TSCA if they are regulated by other federal statutes. Such products include “cosmetics” regulated by the FD&C Act, which are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance.” While the distinction between a cosmetic and personal care product may not always be apparent to the consumer, the difference is crucial with respect to federal oversight of the chemicals contained in the product.
Non-cosmetic, personal care products are regulated under TSCA, as amended by the Frank R. Lautenberg Chemical Safety Act of the 21st Century, which requires the Environmental Protection Agency (EPA) to identify “high-priority chemicals” used in existing commerce and determine whether any current uses of the chemicals “present an unreasonable risk of injury to health or the environment.” Where an unreasonable risk is identified, the EPA has discretion to impose conditions on or outright ban the chemical use. Prior to introducing a new chemical or new use of an existing chemical into commerce, manufacturers are required to provide notice to the EPA so that the agency may assess whether the proposed chemical or use will pose an unreasonable risk. In contrast, chemicals used in cosmetic products are regulated by the Food and Drug Administration (FDA) pursuant to the FD&C Act and generally do not require registration or preapproval by the agency before being introduced into commerce. Moreover, the FDA does not have authority to require a recall where it identifies a potential health hazard in a cosmetic product. However, the FDA does have authority to regulate the labeling of cosmetic products and to outright ban specific ingredients from being used in cosmetics generally.
- State Regulation of Chemicals in Cosmetics and Other Personal Care Products—Newly Enacted Laws and Anticipated Future Legislation
While the regulation of chemicals in cosmetic and personal care products has historically been left to the purview of the EPA and the FDA, in recent years a growing number of states have expressed interest in directly regulating chemicals in cosmetic and personal care products sold within their jurisdictions. In 2019 and 2020, state regulation of these chemicals took a significant step forward as New York and California signed into law two bills regulating chemicals used in cosmetic and/or personal care products. A brief description of both state laws is provided below.
- New York: On December 9, 2019, Governor Cuomo signed into law New York Senate Bill 4389-B/A.6295-A, making New York the first and only state to set a maximum contaminant limit of 1,4-dioxane in consumer products. While there are no direct consumer uses of 1,4-dioxane, the compound may be present in cosmetics and personal care products as a byproduct of the manufacturing process (according to one 2007 Study, approximately 22% of cosmetic and other personal care products may contain 1,4-dioxane). New York’s legislation, which takes effect on December 31, 2022, prohibits the sale of personal care products containing more than 2 ppm of 1,4-dioxane and the sale of cosmetic products containing more than 10 ppm of 1,4-dioxane.
- California: On September 30, 2020, Governor Newsom signed into law the Toxic-Free Cosmetics Act, California Assembly Bill 2762, banning 24 chemicals, including mercury, formaldehyde, and certain types of PFAS, from being used in cosmetic, beauty, and personal care products sold in California. California’s legislation is set to take effect in 2025 and will mark the first state-level prohibition on the various chemicals in cosmetic products.
In addition to New York and California’s recently enacted legislation, there are at least five bills currently being considered by various states that would further regulate chemicals in cosmetic and/or personal care products sold within the respective jurisdictions. A brief summary of these state bills is provided below:
- Connecticut: SB 404—Prohibiting the sale or distribution of consumer products that contain PFAS (currently before the Joint Committee on Public Health).
- Maryland: HB 0643—Prohibiting the sale or distribution of cosmetic products that contain PFAS, mercury, and other chemicals in certain instances (currently passed in both chambers and before the Governor).
- New Jersey: A 189 / S 1843—Prohibiting the sale and distribution of nail salon products that contain dibutyl phthalates, toluene, or formaldehyde (currently before the Assembly Consumer Affairs Committee); A 1720—Prohibiting the sale of hand sanitizers and body cleaning products containing triclosan (currently before the Assembly Consumer Affairs Committee).
- New York: A 143 / S 3331—Creating a list of “chemicals of concerns” known to exist in personal care products, requiring manufacturers of such products to disclose any chemicals of concerns contained in their products and prohibiting the sale of personal care products containing chemicals of concerns after three years (currently referred to Environmental Conservation Committee).
- Federal Preemption of State Laws
As more states continue to adopt new legislation to regulate chemicals in cosmetic and personal care products, manufacturers and/or trade organizations will likely bring preemption challenges to these state regulations. In the context of cosmetic products, the FD&C Act prohibits state or local governments from enacting “any requirement for labeling or packaging of cosmetics that is different from or in addition to, or that is otherwise not identical with” the federal rules. Thus, state laws that do not directly regulate the labeling or packing of cosmetics products but instead regulate the contents of these products will likely not run afoul of the FD&C Act’s preemption clause.
In contrast, state legislation governing chemicals in personal care products may be at a higher risk of being preempted by TSCA. TSCA broadly prohibits the enforcement of any state chemical regulation of a particular substance once the EPA completes a risk evaluation for the substance and either: (1) determines that the chemical will not present an unreasonable risk; or (2) concludes that the chemical presents an unreasonable risk under the circumstances of use, and promulgates a rule that restricts manufacturing or use of the chemical to mitigate the identified risks. Notably, the scope of TSCA’s preemption extends only to chemical uses examined in the EPA’s risk evaluation—meaning that the EPA’s failure to examine the use of a chemical in personal care products would make state regulation fair game. In addition, even where a risk evaluation of a particular chemical has been completed, TSCA will not preempt state laws that (1) only impose reporting, monitoring, or information obligations; or (2) environmental laws that regulate air quality, water quality, or hazardous waste treatment or disposal.
Early insight into the full scope of TSCA’s preemption provisions will likely be provided by anticipated challenges to individual state’s regulation of 1,4-dioxane. As explained above, New York has already taken steps to regulate 1,4-dioxane in personal care products and other states may soon look to follow suit. However, on January 8, 2021, the EPA released its final risk evaluation for 1,4-dioxane under TSCA. See 86 Fed. Reg. 1495. The EPA’s initial risk evaluation identified a number of “use conditions” in which 1,4-dioxane posed an unreasonable risk to occupational workers, but did not consider “use conditions” involving 1,4-dioxane’s presence in consumer products. In response to protests from industry, EPA’s final risk evaluation included a supplemental analysis of eight use conditions for 1,4-dioxane as a byproduct in consumer goods, including use in hobby materials; automotive care products; cleaning and furniture care products; laundry and dishwashing products; paints and coatings; and spray polyurethane foam. No unreasonable risks for these consumer uses were identified. Because the EPA’s supplemental risk evaluation examined but did not find any unreasonable risks from 1,4-dioxane in consumer products, an argument could be made that states are preempted from enacting their own 1,4-dioxane limits in consumer products. However, because the EPA’s risk evaluation did not specifically exclude cosmetic or personal care products, individual states may be able to argue that the preemption scope is limited only to the specific uses of 1,4-dioxane that were specifically examined during EPA’s risk evaluation. The resolution of any challenges to New York and other states’ regulation of 1,4-dioxane in consumer products will likely provide key insights into the scope of TSCA’s preemption powers.
California’s COVID-19 Workplace Safety Standard May Be Revised on Short Notice
By Leah Song
On May 20, 2021, the California Occupational Safety and Health Standards Board (“Board”) held a public meeting to consider revisions to the State’s COVID-19 emergency temporary standard (“ETS”), which had been the applicable law for California workplaces since November 30, 2020. (See December 1, 2020 Corporate Environmental Lawyer blog). On May 7, 2021, the California Division of Occupational Safety and Health (“Cal/OSHA”) issued a notice of emergency action regarding proposed revisions to the ETS for the Board to consider for adoption, given the developing science around COVID‑19, particularly the impact of vaccines and Cal/OSHA’s experience enforcing the ETS. However, on May 19, 2021, Cal/OSHA asked the Board to table its vote on Cal/OSHA’s May 7 proposed COVID-19 ETS revisions.
Given Cal/OSHA’s May 7 proposed revisions to the ETS included notable revisions changing definitions, masking and physical distancing requirements, and engineering controls, including distinctions based on whether employees were vaccinated. However, on May 13, 2021, the Centers for Disease Control and Prevention (“CDC”) posted its guidance for fully vaccinated people recommending, in part, that “fully vaccinated people no longer need to a mask or physically distance in any setting, except where required by federal, local, tribal, or territorial laws, rules, and regulations, including local business and workplace guidance.” CDC, Guidance for Fully Vaccinated People (May 13, 2021). In light of that new guidance, and the science that the risk is low that vaccinated people transmit the virus, Governor Newsom announced that the state will implement the new CDC mask guidelines on June 15, 2021, along with fully reopening the economy. In addition, California Health and Human Services Secretary Dr. Mark Ghaly announced on May 17, 2021 that, starting on June 15, 2021, “California plans to implement the CDC’s guidelines around masking to allow fully vaccinated Californians to go without a mask in most indoor settings.” However, California Department of Public Health issued a directive on May 21, 2021, that adopted the CDC guidance, but also stated that, with respect to COVID-19 protections, employers remain subject to the ETS, as applicable to their business.
On May 19, 2021, the day before the Board meeting, Cal/OSHA sent a memo recommending that the Board not vote on its May 7 proposed revisions, because it “believes it is important to revisit the proposed COVID-19 prevention emergency regulations in light of this new [CDC] guidance.” In the memo, Cal/OSHA stated that it will “limit any potential changes to consideration of the recent [CDC] guidance” regarding fully vaccinated people. On May 20, 2021, after hearing hours of public comment, the Board voted to table Cal/OSHA’s May 7 changes and to allow it to post, by May 28, 2021, its new proposed changes to the ETS for public comment. The Board will vote on June 3, 2021 in a special meeting as to whether to adopt the new Cal/OSHA proposed changes or to take other action on the ETS.
Jenner & Block’s Corporate Environmental Lawyer will continue to update on the California COVID-19 ETS and other COVID-19 matters as they unfold. Additional information regarding working during the COVID‑19 pandemic can be found on this blog and in Jenner & Block’s COVID‑19 Resource Center.
Supreme Court Narrows Triggers for CERCLA Contribution Actions
By Allison A. Torrence
In a unanimous decision authored by Justice Thomas, the Supreme Court of the United States ruled in the case of Guam v. United States, No. 20-382, 593 U.S. __ (2021), that a party must resolve “CERCLA-specific liability” in order to trigger contribution rights under § 113(f)(3)(B) of the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”).
The question before the Court was whether a settlement between Guam and the United States that resolved claims under the Clean Water Act could be the basis for a contribution claim under § 113(f)(3)(B) of CERCLA. In this case, Guam and the U.S. EPA had entered into a Consent Decree following a Clean Water Act lawsuit, settling the United States’ Clean Water Act claims against Guam and requiring Guam take actions to close and cover a dump site. Thirteen years later Guam sued the United States under CERCLA for cost recovery and contribution, claiming the United States’ earlier use of the dump site exposed it to liability. The district court, in a ruling affirmed by the court of appeals, ruled that Guam had a contribution claim at one point, based on its Clean Water Act Consent Decree because that Decree required remedial measures and provided a conditional release, which sufficiently resolved Guam’s liability for the dump site and triggered a CERCLA contribution claim under § 113(f)(3)(B). However, the Decree also triggered the three-year statute of limitations, which had expired, leaving Guam without any viable claims.
The Supreme Court reversed the lower courts, rejecting the notion that the Clean Water Act Consent Decree was sufficiently similar to a CERCLA settlement to trigger contribution liability. The Court focused on a textual analysis of the statute, which states in relevant part that:
A person who has resolved its liability to the United States or a State for some or all of a response action or for some or all of the costs of such action in an administrative or judicially approved settlement may seek contribution from any person who is not party to a [qualifying] settlement.
42 U.S.C. § 9613(f)(3)(B).
Of particular note to the Court was the reference in § 113(f)(3)(B) to “response action”, which is a term of art in CERCLA, and appears throughout the Act. The Court reasoned that this language “is best ‘understood only with reference’ to the CERCLA regime.” Guam, slip op. at 6, quoting United States v. Atlantic Research Corp., 551 U. S. 128, 135 (2007). Thus, according to the Court’s reasoning, to resolve liability for a “response action,” a party must engage in a CERCLA-specific settlement, not “settle an environmental liability that might have been actionable under CERCLA.” Id. at 7.
In conclusion, the Court held that “[t]he most natural reading of §113(f)(3)(B) is that a party may seek contribution under CERCLA only after settling a CERCLA-specific liability.” Id. at 9.
Like most major CERCLA decisions, the Court’s ruling answers one question but raises many more. We can expect future litigation on the precise bounds of how specific a settlement need be to qualify as “CERCLA-specific” under the Court’s holding. There will also likely be litigation regarding how this ruling may apply to other provision of CERCLA beyond §113(f )(3)(B). As always, the Corporate Environmental Lawyer Blog will be monitoring these important developments and reporting on what you need to know.
Supreme Court Procedural Clarity Provides Win for Industry in Climate Case
By Leah Song
On May 17, 2021, the United States Supreme Court ruled 7-1 that the Fourth Circuit should have considered all of the fossil fuel companies’ grounds for removal to federal court in the BP PLC, et al. v. Mayor and City Council of Baltimore case.
As previously discussed by the Corporate Environmental Lawyer blog, the underlying litigation involves claims asserted in Maryland state court by the City of Baltimore against various fossil-fuel companies for damages associated with climate change. In its complaint, Baltimore asserted claims against the industry for public nuisance, private nuisance, strict liability failure to warn, strict liability design defect, negligent design defect, negligent failure to warn, trespass, and violations of Maryland’s Consumer Protection Act.
In response to Baltimore’s complaint, the fossil fuel companies sought to remove the action to federal court, as they have done in all of the state court actions filed by municipalities and states making similar claims. The fossil fuel companies’ removal petition was based on multiple grounds, including the “federal officer” removal provision, 28 U.S.C. §1442(a)(1), and multiple other federal statutes that industry believed justified federal court jurisdiction. The City sought remand to state court, and the federal district court, after having reviewed each of the removal arguments, found that industry had not asserted an appropriate basis for federal jurisdiction. Industry then appealed that district court remand decision to the U.S. Court of Appeals for the Fourth Circuit, pursuant to 28 U.S.C. §1447(d), which expressly authorizes appellate review for removals based on 28 U.S.C. §1443 (civil rights removal), as well as §1442.
On March 6, 2020, the Fourth Circuit affirmed the district court’s remand order, but did so only after reviewing the industry’s right to removal under the federal officer removal statute, 28 U.S.C. §1442(a)(1). The Fourth Circuit found that 28 U.S.C. §1447(d) limited its appellate review solely to that issue, and not any of the other bases that industry had asserted in support of its argument for federal removal jurisdiction. The Fourth Circuit’s decision regarding the scope of review under § 1447(d) was consistent with prior decisions from the First, Ninth and Tenth circuits but conflicted with a previous decision from the Seventh Circuit.
On March 31, 2020, the fossil-fuel companies filed a petition for a writ of certiorari in the United States Supreme Court, seeking review of the question of whether the statutory provision prescribing the scope of appellate review of remand orders “permits a court of appeals to review any issue encompassed in a district court’s order remanding a removed case to state court…” The companies argued that the Fourth Circuit had improperly ignored several alternative grounds justifying removal of the case to federal court, including that federal common law governs claims of interstate air pollution. The Supreme Court granted a writ of certiorari to review the case on October 2, 2020.
On May 17, 2021, the Supreme Court ruled that the Fourth Circuit erred in holding that it lacked jurisdiction to consider all of the defendants’ grounds for removal under §1447(d). BP PLC, et al. v. Mayor and City Council of Baltimore, 593 U.S. ____(2021). The Court held that, once the defendants removed the case in reliance on §1442 “and the district court ordered the case remanded to the state court, the whole of its order became reviewable on appeal.” Slip op., No. 19-1189, at 5. The Court based its decision on an interpretation of the language of §1447(d). The decision, authored by Justice Gorsuch, emphasized in the second sentence of its opinion that “the merits of [the City’s climate change] claim have nothing to do with this appeal. The only question before us is one of civil procedure[.]” Id. at 1. The Supreme Court also noted that it would not consider the merits of the defendants’ removal arguments, finding that “the wiser course is to leave these matters for the Fourth Circuit to resolve in the first instance.” Id. at 14.
Justice Sotomayor wrote the lone dissent, based on her view that the longstanding rule has been that remand orders are generally not subject to appellate review. Slip op. at 1 (Sotomayor, J., dissenting). Justice Sotomayor asserted that the majority’s interpretation “lets defendants sidestep §1447(d)’s bar on appellate review by shoehorning a §1442 or §1443 argument into their case for removal. In other words, it lets the exception swallow the rule.” Id. at 2 . “Unfortunately, I fear today’s decision will reward defendants for raising strained theories of removal under §1442 or §1443 by allowing them to circumvent the bar on appellate review entirely.” Id. at 7.
Justice Alito took no part in the consideration or decision of this case.
Although the case is now remanded for further consideration to the Fourth Circuit to consider the additional bases raised by defendants in support of their removal petition, parties across the country now have clarity as to which arguments the appellate court must consider when reviewing removal petitions.
Jenner & Block’s Corporate Environmental Lawyer will continue to update on climate change litigation cases as they unfold.
EPA Announces Plans to Require Additional Chemical Reporting under its Toxic Release Inventory
By Matthew G. Lawson
On Friday, April 30, 2021, the Biden Administration’s Environmental Protection Agency (EPA) announced significant steps the agency intends to take under the Toxics Release Inventory (TRI) Program to implement expanded reporting requirements for companies that store and utilize hazardous chemicals, including new obligations to report the storage, use and any releases of ethylene oxide, a commonly used industrial chemical and sterilant for medical equipment and supplies. The TRI Program, which was established under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), serves as a resource for the public to learn about annual chemical releases, waste management, and pollution prevention activities reported by nearly 22,000 industrial and federal facilities. Under the TRI Program, U.S. facilities operating in various industry sectors must report annually the quantity of certain chemicals they release to the environment and/or manage through recycling, energy recovery and treatment. A “release” of a chemical in the context of the TRI Program means that the chemical is emitted to the air or water, or placed in some type of land disposal.
A major component of EPA’s announcement is the agency’s intent to regulate ethylene oxide. The use and release of ethylene oxide by medical device sterilization companies have prompted a number of recent high-profile lawsuits alleging that releases of the chemical into the environment have caused increased cancer rates in communities adjacent to the facilities. EPA’s announcement notes that many existing sterilization facilities “are located near areas with Environmental Justice concerns,” and that individuals living adjacent to these facilities may be at a heightened risk from exposure to ethylene oxide. “Every person in the United States has a right to know about what chemicals are released into their communities,” EPA Administrator Michael S. Regan stated. “By requiring new and more data on chemical releases from facilities, EPA and its partners will be better equipped to protect the health of every individual, including people of color and low-income communities that are often located near these facilities but have been left out of the conversation for too long.” In the coming months, EPA will provide further details regarding the specific actions the agency intends to take to require sterilization facilities that use ethylene oxide to report under the TRI Program.
In addition to implementing new reporting requirements for companies utilizing ethylene oxide, EPA announced several other steps the agency plans to take that will increase reporting and public access to information under the TRI Program, including:
- Finalizing a longstanding proposed rule that will add natural gas processing facilities to the industry sectors covered under the TRI Program thereby increasing the publicly available information on chemical releases and other waste management activities of TRI-listed chemicals from this sector;
- Continuing to add new per- and polyfluoroalkyl substances (“PFAS”) to the list of chemicals that require reporting under the TRI Program, including the addition of perfluorobutane sulfonic acid (PFBS) following EPA’s toxicity assessment of the substance;
- Proposing a new rule to add high-priority substances under the Toxic Substances Control Act (TSCA) and chemicals included in the TSCA workplan to the list of chemicals that require reporting under the TRI Program; and
- Increasing public access to TRI data through improved search functionality and improved website interface.
EPA’s announcement marks the most recent step by the agency to implement the Biden Administration’s focus on environmental justice as a top priority of its environmental agenda. On the same day that EPA announced the agency’s updated TRI policy, EPA circulated a memorandum to all EPA-staff, indicating the additional actions the agency intends to take to fulfill its environmental justice commitment. These actions include: (1) increasing inspections of facilities that pose the most serious threats to overburdened communities; (2) focusing on implementing remedies that benefit communities, including through the incorporation of supplemental environmental projects; (3) increasing communications with overburdened communities to develop improved cleanup and non-compliance solutions; and (4) identifying locations where state regulators are not adequately protecting local communities and taking increased enforcement actions to “pick up the slack” if state regulators have not taken appropriate or timely actions.
The Corporate Environmental Blog will continue to follow developments on this issue in the coming months as EPA provides additional details on the specific actions it intends to take to expand the TRI Program.
Jenner & Block to Host Webinar on EHS Issues Facing the Cannabis Industry
On May 4, Jenner & Block Partner Steven M. Siros and Associate Leah M. Song will present a CLE webinar on environmental, health, and safety (EHS) issues facing the cannabis industry. The market value of the cannabis industry in the United States is expected to reach $30 billion by 2025. Currently, 36 states allow the use of cannabis for medicinal purposes and 15 states allow the recreational use of cannabis. To sustain this rapid industry growth, and avoid potential penalties and lawsuits, it is crucial that cannabis companies ensure consistent compliance with EHS rules and regulations.
In this CLE Program, Mr. Siros and Ms. Song will cover the particular EHS challenges that the cannabis industry currently faces, including issues related to emissions, water resources, waste regulation, and pesticides. The program will also address worker safety issues and the state and federal OSHA regulations cannabis operations are subject to as well as post-consumer issues cannabis companies face such as packaging issues and recycling. Please email firstname.lastname@example.org if you are interested in attending. Space is limited.
Mr. Siros is chair of the Environmental Litigation Practice and co-chair of the Environmental Workplace Health & Safety Law Practice. He focuses primarily on environmental and toxic tort matters.
Ms. Song is an associate in the firm’s Environmental and Workplace Health & Safety Law Practice.
Earth Day 2021: CERCLA and RCRA in The Biden Administration: Elevating Climate Change and Environmental Justice in Addressing Hazardous Wastes
By Andi S. Kenney
We close out the Corporate Environmental Lawyer Blog's weeklong celebration of Earth Day with the two federal programs aimed at cleaning up existing toxic waste sites and preventing the creation of new ones: the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (“CERCLA”) and the Resource Conservation and Recovery Act (“RCRA”). The Trump Administration considered the remedial and regulatory roles of the CERCLA and RCRA programs as core EPA functions, so it did not target them for regulatory rollbacks like it did for many federal clean air (including climate change), clean water, and environmental review requirements. Nonetheless, the new occupant of the White House will change the focus of both these programs—in large part by elevating climate change and environmental justice considerations in decision-making.
Early in the Trump Administration, Scott Pruitt, then the EPA Administrator convened a Superfund Task Force that identified five priorities: (1) expediting cleanup and remediation, (2) invigorating responsible party cleanup and reuse, (3) encouraging private party investment, (4) promoting redevelopment and community revitalization, and (5) engaging partners and stakeholders. The Task Force set forth 42 recommendations to achieve those goals.
Following the Task Force recommendations, the Trump Administration prioritized 54 sites and completed remediation and delisted over 50 sites from the National Priorities List. The focus was often sites with redevelopment potential. At many of those sites, surprisingly aggressive settlements with potentially responsible parties funded the work. At the same time, however, the number of unfunded orphan sites (those with remediation plans but no funding source) grew as federal appropriations were limited. By January 2021, there were at least 34 unfunded orphan sites, many in at-risk areas.
The Biden Administration is expected to retain the goals and many of the recommendations from the Task Force, but it will redeploy resources to meet its priorities. Climate change (a phrase that literally had been removed from the Superfund Strategic Plan), and environmental justice (which seeks to address the disproportionately high health and environmental risks found among low-income and minority communities) will reemerge as key considerations in CERCLA decision-making, especially in site prioritization and remediation plans. A 2019 GAO report indicated that these issues are often linked. It identified roughly 2/3 (975/1570) of the NPL listed Superfund sites as vulnerable to climate-related risks—hurricanes, flooding, wildfires and/or rising sea levels. Many of these sites were also located near low-income and minority communities. Biden will seek to pair his climate change and environmental justice goals with his redevelopment and infrastructure plans through Brownfield grants and other incentives.
The Biden Administration has also signaled it will address emerging contaminants. As noted by Steve Siros in Wednesday's Corporate Environmental Lawyer Blog, EPA is likely to designate per- and polyfluoroalkyl substances (“PFAS”) as “hazardous substances” under CERCLA and may set a maximum contaminant level (“MCL”) for these compounds under the Safe Drinking Water Act (“SDWA”). These actions could have a significant impact on new and existing cleanups. First, designating PFAS a “hazardous substance” would require facilities to report PFAS releases, which could trigger more investigations and cleanups. Second, any PFAS limits under the SDWA or state regulations would become Applicable or Relevant and Appropriate Requirements (“ARARs”) that would have to be considered in CERCLA listing and remedy decisions. Finally, these changes would require PFAS contamination to be evaluated in EPA’s five year review at each site and potentially trigger reopeners in prior settlements. Tighter standards for other chemicals, such as 1,4-dioxane, could have similar results.
Resources are already being deployed to support these efforts and additional funding for Brownfield and Superfund projects is in the works. The American Rescue Plan Act of 2021 provides $100 million for EPA grants to address disproportionate environmental harms to at-risk populations and air quality monitoring. According to the American Jobs Plan Fact Sheet dated March 31, 2021, the Administration is proposing an additional $5 billion for Brownfield and Superfund sites and an additional $10 billion to monitor and remediate PFAS. The Administration is also proposing to restore the Superfund tax, which expired in 1995, to ensure that resources are available in the Superfund Trust to address unfunded site cleanups. Similarly, the Administration is considering reversing the financial responsibility exemption for chemical manufacturers, petroleum and coal products manufacturers and electric power generation, transmission and distribution facilities that was issued in the waning days of the previous Administration.
Like CERCLA, RCRA was not a focus of the Trump Administration’s regulatory rollbacks—though funding cutbacks affected rule development and enforcement. The Biden Administration has already signaled that it intends to reenergize enforcement, including criminal prosecutions, which may lead to an increase in federal overfiling in RCRA enforcement actions, especially in states with lax enforcement histories.
Trump’s most significant RCRA actions addressed coal ash, referred to as Coal Combustion Residuals (“CCR”). The Trump CCR rules, which were promulgated after the Obama-era CCR rule was vacated, are being reviewed for consistency with Biden’s Executive Order Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis. Likewise, the CCR Permit Program and the Beneficial Use Rules or Electric Utilities, which were pending on Inauguration Day, are subject to the Presidential memorandum freezing regulations pending review.
Biden’s focus on environmental justice and climate change will impact RCRA permit evaluations and enforcement, both in process and in substance. Procedurally, those seeking RCRA permits, and even RCRA permitted facilities, may be subject to additional notification requirements, more community involvement, and greater scrutiny. Substantively, the social cost of carbon and chemical exposure risks will become part of the evaluation.
Biden’s other climate change initiatives may have more significant RCRA impacts down the road. For example, the push toward electric vehicles will reduce the demand for gas stations at current levels. That change, combined with the fact that underground storage tanks installed or upgraded to comply with the 1988 underground storage tank standards are nearing the end of their useful lives, will trigger tank closures throughout the country. More broadly, the transition from a fossil fuel economy to a clean fuel economy will reveal many other environmental issues that will require substantial efforts and resources to address.
The Biden Administration is already changing the course of environmental law. With CERCLA and RCRA, the shifts will be more subtle than in other areas, but the focus on climate change and environmental justice will have profound impacts on whose voices are heard and where, and how, resources are deployed. The Corporate Environmental Lawyer Blog will continue to monitor and report on developments in these areas and others. In the meantime, thank you for sharing Earth Day (and Earth Week) with us!
Earth Day 2021: Biden’s American Jobs Plan Aims to End the Flow of Lead in Drinking Water
By Allison A. Torrence
As the Corporate Environmental Lawyer Blog celebrates Earth Day, we turn to the important topic of drinking water. Drinking water, like the air we breathe, is an environmental issue that everyone interacts with on a daily basis. But, much like air pollution, contamination of drinking water often has the largest impact on poor communities and communities of color.
In a 2019 report co-authored by environmental organizations Natural Resources Defense Council (“NRDC”), Coming Clean, and Environmental Justice Health Alliance (“EJHA”), the groups analyzed EPA data on community drinking water systems, concluding that there “is unequal access to safe drinking water, based most strongly on race.” The report made several important findings that lead to this conclusion, including:
- Drinking water systems that constantly violated the law for years were 40 percent more likely to occur in places with higher percentages of residents who were people of color.
- Nearly 130 million people in the U.S. got their drinking water from systems that violated federal law during the time period reviewed in the report.
- Small systems – those that serve less than 3,300 people – were responsible for more than 80% of all violations. The EPA has noted many small systems are “likely to serve low-income, vulnerable populations.”
While there are many contaminants that communities monitor for in drinking water, lead is one of the most public and concerning drinking water contaminants of concern. Lead in drinking water is caused by the very pipes and service lines bringing us our water, entering the water when a chemical reaction occurs in plumbing materials that contain lead. As we saw in the Flint, Michigan lead water crisis in 2016, this corrosion of metal from the pipes and fixtures is more severe when water has high acidity or low mineral content.
Lead in drinking water has been a target of environmental activists and agencies for years. Recently, EPA amended its Lead and Copper Drinking Water Rule, under the authority of the Safe Drinking Water Act, to add a new lead trigger level for drinking water monitoring and add more proactive measures to identify upgrades needed to reduce the effects of deteriorating infrastructure. However, this rule was finalized at the end of the Trump Administration and the Biden Administration extended the effective date through June 2021, likely to be pushed back further as Biden’s EPA evaluates whether it wants to make additional changes.
Taking a bolder step, President Biden’s latest proposed legislation under his “Build Back Better” agenda—the American Jobs Plan—includes significant funding and plans to address lead in drinking water. According to the American Jobs Plan Fact Sheet:
“President Biden’s plan will eliminate all lead pipes and service lines in our drinking water systems, improving the health of our country’s children and communities of color.”
The current proposal includes $45 billion to replace every lead water line across the nation. In addition to the lead-specific funding, the American Jobs Plan proposes funding for broader drinking water improvements, including $56 billion to upgrade and modernize drinking water supplies through grants and low-cost flexible loans to states, Tribes, territories, and disadvantaged communities; and $10 billion to provide funding to monitor PFAS substances in drinking water and invest in rural small water systems & household well & wastewater systems.
This drinking water funding is just one small part of the $2.65 trillion plan, but it will likely continue to play an important part of the President’s agenda. The Corporate Environmental Lawyer Blog will stay on top of all relevant developments as negotiations on the American Jobs Plan and other drinking water proposals advance.
Earth Day 2021: Heightened Chemical Regulation under the Biden Administration
By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
A key platform of President Biden’s environmental agenda is increased regulatory scrutiny with respect to chemical substances under the Toxic Substances Control Act (TSCA). Regulating chemicals in order to minimize the threat to human health and the environment is clearly also critical to achieving the aims and goals of Earth Day, especially considering that the publication of Rachel Carson’s Silent Spring helped spark the global environmental movement that eventually culminated in the first Earth Day in 1970.
Turning now to the present, in the waning months of the Trump administration, there was a flurry of U.S. EPA activity under TSCA, including the issuance of risk evaluations for a number of high-priority chemical substances, including asbestos, 1,4-dioxane, and trichloroethylene. Notwithstanding that these risk evaluations concluded that at least some uses of each of the ten high priority chemicals posed an unreasonable risk, these risk evaluations were widely criticized for failing to take into consideration reasonably foreseeable uses or failing to adequately consider various scientific studies. There had been much speculation that President Biden would reject all of the Trump-era TSCA risk evaluations and in fact, one of President Biden’s first actions in the White House was to direct U.S. EPA to review the TSCA risk evaluation process as well as the methylene chloride risk evaluation specifically.
Rather than throwing the baby out with the bathwater, however, U.S. EPA is moving forward to develop risk mitigation plans for each of these high priority chemicals. At the same time, Michal Freedhoff, the acting assistant administrator for U.S. EPA’s Office of Chemical Safety and Pollution, noted that U.S. EPA would be taking a hard look at these risk evaluations. In a prepared statement, Ms. Freedhoff stated:
Our goal is to allow risk management actions on these first ten chemicals to move forward as much as possible, while looking back surgically at specific areas in some of the risk evaluations to supplement them as appropriate in order to ensure we are meeting our statutory obligations and using the best available science to truly protect human health and the environment.
As to the next 20 chemicals in the risk assessment pipeline, U.S. EPA has already announced that it will reassess its TSCA risk evaluation process, including refining its approach for selecting and reviewing scientific studies. U.S. EPA noted that it would not rely on U.S. EPA’s Application of Systematic Review in TSCA Risk Evaluations, a guidance document issued by U.S. EPA in 2018 that was much maligned by the National Academy of Scientists.
One can also expect an increased focus on environmental justice issues by U.S. EPA in connection with evaluating the risks posed by chemical substances. This will most likely play out in connection with an increased focus on chemical substance exposure for fence-line and front-line communities during the risk evaluation process.
Finally, there will also be increasing pressure on the Biden Administration to regulate new emerging contaminants such as per- and polyfluoroalkyl substances (PFAS) under both TSCA and the Safe Drinking Water Act. PFAS compounds have not yet been considered for prioritization under TSCA but are likely to be on a list of high priority chemicals in the future. In the meantime, U.S. EPA is likely to move forward with designating at least PFAS compounds as hazardous substances under CERCLA as well as evaluating whether to set an MCL for these compounds under the Safe Drinking Water Act.
Please check back on Jenner & Block’s Corporate Environmental Lawyer for more Earth Day content throughout the week.
Earth Day 2021: Climate Change under the Biden Administration
By Leah Song
President Biden has made climate change a main focus of his administration. At the beginning of his term, President Biden issued several executive orders addressing climate change: “Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis” (January 20, 2021) and “Executive Order on Tackling the Climate Crisis at Home and Abroad” (January 27, 2021) (“Day 7 Environmental Executive Order”). This article will highlight the administration’s international focus, climate justice, climate litigation, and several priorities of the recent executive orders.
As President Biden promised prior to inauguration, he recommitted the U.S. to the Paris Climate Agreement, which is intended to limit the global temperature increase to 2 degrees Celsius above pre-industrial levels. Trump had announced his intent to terminate the U.S.’s involvement in the Paris Climate Agreement shortly after taking office, but due to the rules, was not able to formally withdraw until November 4, 2019, which became final a year later on November 4, 2020. The U.S. had originally committed to cut GHG emissions by at least 26% below 2005 levels by 2025. Countries were supposed to submit new targets for 2030 by the end of 2020. The Biden administration will likely submit its updated Nationally Determined Contribution (“NDC”) by the end of 2021 in time for the COP26 event scheduled at the end of the year. Given the rollbacks during the Trump administration and predicted increase in emissions as the world recovers from the COVID-19 pandemic, President Biden will need to carefully consider the new target NDCs.
Keeping with the international focus, the Biden administration committed to treating climate change as a national security threat and fully integrating climate change into foreign policy and national security strategies. President Biden selected former Secretary of State John Kerry as the Special Presidential Envoy for Climate and to sit on the National Security Council. Kerry’s role is complemented by Gina McCarthy, White House National Climate Advisor, and Ali Zaidi, Deputy White House National Climate Advisor, in the White House Office of Domestic Climate Policy. The Day 7 Environmental Executive Order also discusses the establishment of a National Climate Task Force, working across 21 federal agencies and departments to enable a “whole-of-government” approach to combatting the climate crisis. For summaries of the recent National Climate Task Force meetings, click here and here.
During his campaign and into his presidency, President Biden has made clear his focus on environmental and climate justice. The Day 7 Environmental Executive Order establishes the White House Environmental Justice Advisory Council and the White House Environmental Justice Interagency Council in order to prioritize environmental justice and ensure a “whole-of-government” approach to addressing current and historical environmental injustices. There will be a focus on environmental justice monitoring and enforcement through new or strengthened offices at the U.S. Environmental Protection Agency, Department of Justice, and Department of Health and Human Services.
In time for Earth Day, the administration invited 40 world leaders to the Leaders Summit on Climate that will be hosted on April 22 and 23. The virtual Leaders Summit will be live streamed for public viewing. For an initial overview of the Leaders Summit, click here.
Check back on Jenner & Block’s Corporate Environmental Lawyer for more Earth Day content throughout the week.