State Court Legal Challenge to Illinois Gov. Pritzker’s COVID‑19 Executive Orders
By Leah Song and Gabrielle Sigel
Although Illinois Governor Pritzker has scored successes in the federal lawsuits brought against his COVID‑19 Executive Order actions, he has not fared as well, thus far, in state court.
Back on April 23, 2020, Illinois State Representative (R) Darren Bailey filed a complaint in the Clay County Circuit Court with two counts for declaratory judgment and a request for injunction, alleging that Governor Pritzker’s extension of the stay-at-home order exceeded the authority afforded to the Governor under the Illinois Emergency Management Agency Act (“IEMAA”). Specifically, the lawsuit alleged that the IEMAA grants certain enumerated powers to the Illinois Governor following the proclamation of a “public health emergency,” but that Section 7 of the IEMAA limits these authorities to “a period not to exceed 30 days” following the declaration. Thus, Rep. Bailey alleged that any extension of the stay-at-home order 30 days after the original Executive Order was void. On the same date that he filed his complaint, Rep. Bailey filed a motion seeking a temporary restraining order (“TRO”) to enjoin Governor Pritzker from enforcing the stay-at-home order against him or entering any further executive orders that would limit Rep. Bailey’s ability to travel within the state.
On April 27, 2020, Illinois Circuit Court Judge Michael McHaney temporarily blocked enforcement of Governor Pritzker’s stay-at-home order by granting Rep. Bailey the TRO, solely as to him. In its order granting the TRO, the circuit court found that Rep. Bailey had “shown he will suffer irreparable harm if the [TRO] is not issued” and had “shown he has no adequate remedy at law or in equity in that absent a [TRO] being entered, plaintiff, will continue to be isolated and quarantined in his home.” On that same day, Governor Pritzker filed a notice of interlocutory appeal to the Appellate Court of Illinois, Fifth Judicial District, requesting that the court reverse and vacate Judge McHaney’s decision and dissolve the TRO. On April 30, 2020, Rep. Bailey filed in the Fifth District Appellate Court a consent to entry of order vacating the TRO and remanding the case back to the circuit court, which the court agreed to do on May 1, 2020.
On remand, Rep. Bailey filed an amended complaint on May 13, 2020, consisting of four counts seeking the follow relief:
- “Declaratory judgment finding that the April 30 Proclamation is void for failing to meet the definition of a disaster as defined in the IEMAA;”
- “Declaratory judgment finding that Pritzker had no authority to utilize emergency powers after April 08, 2020;”
- “Declaratory judgment finding that the Illinois Department of Public Health Act governs the conduct of the state actors in this context;” and
- “[I]njunctive relief.”
Shortly after, on May 18, 2020, Rep. Bailey filed a motion for summary judgment. Before the hearing on the summary judgment motion, the Governor removed the case to federal court, but it was ultimately remanded. The U.S. Department of Justice got involved in this legal battle, filing a brief in federal court arguing that this case belonged in state court.
Following the remand from federal court, Rep. Bailey filed a notice of hearing on his summary judgment motion. On July 2, 2020, Judge McHaney ruled in favor of Rep. Bailey and held that Governor Pritzker’s COVID-19 Executive Orders were void and granted summary judgment on two counts (“July 2 Order”). The court concluded that the “30-days of emergency powers provided in Section 7 of IEMAA … lapsed on April 08, 2020,” such that all COVID-19 Executive Orders after April 8, 2020 are “void ab initio.” Further, the Governor had no authority “to restrict a citizen’s movement or activities and/or forcibly close business premises.” The court also granted Rep. Bailey’s “oral request that his Amended Complaint be a representative action” such that this ruling shall “apply to all citizens of the State of Illinois.”
The court must rule on the remaining issue of whether COVID-19 “meets the definition of a disaster as defined in the IEMAA.” Until then, the July 2 Order is neither enforceable nor appealable. The Illinois Attorney General moved to dismiss the remaining count and a hearing was set for July 17, but it was vacated by agreement. On July 22, Rep. Bailey filed a motion for leave to amend and add an additional count, seeking a declaratory judgment that a “public health emergency” as defined by the IEMAA did not exist in Clay County on June 26, 2020, when Governor Pritzker issued a proclamation that a “public health emergency” existed within all Illinois counties as a result of COVID-19.
Most recently, on August 5, 2020, Rep. Bailey filed a Petition for Adjudication for Indirect Civil Contempt, seeking to hold Governor Pritzker in civil contempt of court for disregarding the July 2 Order and continuing to issue COVID-19 Executive Orders. Judge McHaney ordered Governor Pritzker to appear in the Clay County Courthouse on August 14, 2020 to “show cause why he should not be held in indirect civil contempt and sanctioned for his willful disregard with the previously entered order of the Court.” The order stated that failure to appear may result in a warrant for the Governor’s arrest. But on August 11, 2020, the Illinois Supreme Court issued an order to stay the contempt hearing set for this Friday.
On July 23 and 24, 2020, Rep. Bailey’s attorney filed similar cases in various counties across the state, including Bond, Clinton, Edgar, Richland, and Sangamon counties, all seeking a declaratory judgment that a “public health emergency” as defined by the IEMAA did not exist as of June 26, 2020 and to void the Governor’s Executive Orders. . See Craig v. Pritzker, No. 2020-MR-589 (Sangamon Cty. Cir. Ct., Ill.); Allen v. Pritzker, No. 2020-MR-45 (Edgar Cty. Cir. Ct., Ill.); DeVore v. Pritzker, No. 2020- MR-32 (Bond Cty. Cir. Ct., Ill.); Gorazd v. Pritzker, No. 2020-MR-79 (Clinton Cty. Cir. Ct., Ill.); English v. Pritzker, No. 2020-MR-48 (Richland Cty. Cir. Ct., Ill.).
On August 11, 2020, in response to a motion for a supervisory order filed by the Illinois Attorney General on behalf of the Governor, the Illinois Supreme Court consolidated, in the Sangamon County Circuit Court before Judge Grischow, all of the cases filed in various counties, including Rep. Bailey’s lawsuit. Sangamon County includes the city of Springfield, the Capitol of Illinois.
An analysis of the Governor’s successes upholding his Executive Orders in federal court can be found here. For regular updates about the impact of COVID‑19 in the workplace and on business generally, please visit Jenner & Block’s Corporate Environmental Lawyer blog and Jenner & Block’s COVID‑19 Resource Center.
OEHHA Proposes Additional Safe Harbor Levels for Cooked or Heat-Processed Foods Containing Proposition 65 Chemicals
By Matthew G. Lawson
On Tuesday, August 4, 2020, the California Environmental Protection Agency Office of Environmental Health Hazard Assessment (OEHHA) issued a Notice of Proposed Rulemaking to adopt amendments to the regulations implementing the Safe Drinking Water and Toxic Enforcement Act of 1986 (“Proposition 65”). Specifically, OEHHA is proposing to amend Title 27 of the California Code of Regulations, by adopting a new Section 25505, to address listed chemicals formed by cooking or heat processing foods. The proposed amendments, if adopted, would provide new, specific “safe harbor” levels for Proposition 65 listed chemicals that are caused by cooking or heat processing in certain food groups. Manufacturers and sellers of these food products in California could then rely on these levels to demonstrate that their products do not require a consumer warning label under Proposition 65.
In general, Proposition 65 requires that parties manufacturing, distributing, or selling consumer products in California provide a “clear and reasonable warning” to the consumer whenever their product may expose the purchaser to a chemical that OEHHA has identified and listed as a carcinogen or reproductive toxin, unless an exception applies. A key exemption to Proposition 65’s warning requirements includes where a consumer product will not exposure a consumer to a listed chemical in quantities above certain OEHHA-designated Safe Harbor Levels. Safe Harbor Levels, which include No Significant Risk Levels (NSRLs) for cancer-causing chemicals and Maximum Allowable Dose Levels (MADLs) for chemicals causing reproductive toxicity, have been established for many of the chemicals listed under Proposition 65 and represent the maximum level of exposure to a chemical that has been deemed “safe” by OEHHA. Products that expose consumers to chemicals at or below a designated Safe Harbor Level are not required to provide a warning label or otherwise warn consumers about potential exposure to the listed chemical in their product. Critically, Proposition 65’s warning requirements are almost entirely forced through litigation brought by private party plaintiffs. In 2018 alone, defendants paid over $35 million in settlements to private party plaintiffs, with over 75% going to attorneys’ fees.
Of particular significance to OEHHA’s proposed regulatory amendment is the Proposition 65 listed chemical acrylamide, which can often form in certain plant-based foods during high-temperature cooking processes, such as frying, roasting, or baking. Acrylamide was first added as a Proposition 65 listed chemical in 1990 after studies showed it had the potential to produce cancer in laboratory mice. Acrylamide was additionally listed as a reproductive toxin in February 2011, when OEHHA determined that the chemical could cause reproductive effects in mice. Despite the relatively long period of time Acrylamide has been listed as a Proposition 65 regulated chemical, private party enforcement actions over the chemical have spiked heavily in recent years. In response, on October 7, 2019, the California Chamber of Commerce filed suit in federal court against the California Attorney General, Xavier Becerra, seeking to block enforcement of Proposition 65’s warning requirements for foods containing acrylamide as the result of the normal cooking process. The Chamber’s complaint alleged that more than 461 companies have received Proposition 65 notice of violations “in connection with alleged exposures to acrylamide in their food products over the past three years.” The complaint further noted that the creation of acrylamide is an unavoidable effect of cooking many plant-based foods and that “there is a lack of reliable scientific evidence suggesting a causal relationship between acrylamide in food products and cancer risk in humans.”
OEHHA’s proposed regulatory amendment appears aimed at addressing the specific concerns asserted in the Chamber of Commerce litigation. In its Statement of Reasons for the proposed amendments, OEHHA acknowledge that the regulatory amendment was needed because “some degree of formation of listed chemicals in many foods is unavoidable when the foods are cooked or otherwise processed with heat.” In addition, OEHHA noted that the agency would consider adding additional food groups to the proposed regulations at a later date.
The proposed regulations provide that a Proposition 65 “exposure” does not occur where a listed chemical in a food product “was created by cooking or other heat processing” and “the producer, manufacturer, distributor, or holder of the food has utilized quality control measures that reduce the chemical to the lowest level currently feasible.” In conjunction with this amendment, the amended regulations provide new Safe Harbor maximum concentration levels for listed chemicals in certain cooked or heated foods that are deemed by OEHHA to be the “lowest level currently feasible.” Food products containing a listed chemical at or below the listed levels are not required to provide a warning under Proposition 65. Listed food groups with specific new Safe Harbor Levels covered by the regulation include:
- Almonds, roasted, roasted almond butter, and chocolate-covered almonds;
- Bread, wheat and non-wheat-based products including loaves, rolls, buns, and baguettes;
- Cookies, including animal crackers, thin and crispy cookies, and sandwich wafers;
- Potatoes and sweet potato products, including french fried potatoes, sliced chips, and other potato products such as hash browns and potato puffs;
- Prune juice, including made from concentrate and non-concentrate; and
Notwithstanding the new proposed Safe Harbor Levels, the last sentence in new Section 25505(a) could still result in Proposition 65 claims. The sentence provides “[i]f a person does not reduce the level of the chemical in a food to the lowest level currently feasible, the resulting exposure must be calculated without regard to the levels set out in subsection (d).” Although this may not have been the intent of OEHHA, this language could be read to allow a Proposition 65 plaintiff to still claim that a manufacturer failed to utilize control measures that reduce the chemicals to the “lowest level currently feasible” even if below the Safe Harbor Level. Hopefully OEHHA will clear up this potential ambiguity in any final rule.
We also note that while the newly proposed amendments may assist many potential defendants, the updated Safe Harbor Levels explicitly will not apply “to parties to an existing court-ordered settlement or final judgment to the extent that such settlement or judgment establishes a concentration of the chemical in a specific product covered in the settlement or judgment.”
OEHHA is currently accepting written comments concerning its proposed regulatory action and intends to close its comment period no later than October 6, 2020. At present, OEHHA has not announced an intended final publication date for the proposed regulations, but the agency has noted that it anticipated its regulatory process may be delayed “due to the COVID-19 emergency.”
Does Environmental Investigation and Remediation Continue Despite COVID-19 Business Restrictions and Social Distancing?
By: Alexander J. Bandza, Steven M. Siros, and Gabrielle Sigel
As the United States rapidly transitions to working from home (when possible) companies involved in environmental investigations or remediation work must determine whether such field or other work could, should, or must continue in the days, weeks, and months ahead. The world is pivoting to tackle COVID-19, a public health crisis, and many of the “essential services” exempted from stay-at-home/shelter-in-place orders (“Restriction Orders”) include work involving public health and safety, as well as critical infrastructure services. Therefore, any person with ongoing environmental investigation and remediation work (“environmental field work”) has to consider whether that work would be or should be included in the category of “essential services.”
From a policy standpoint, whether environmental field work should be considered “essential” requires an evaluation of the people and the environment potentially put at risk, the likelihood of that risk, and the resources the work uses. Continuation of environmental field work may benefit public health and the environment, but it also is occurring at some cost to public health and safety. For example, environmental projects use personal protective equipment (“PPE”) and laboratory equipment and personnel that may be able to be allocated to medical and other scientific research needs. Furthermore, some environmental field work requires close human contact and, at a minimum, will require travel to work and other activities that the Restriction Orders and federal and CDC guidelines are seeking to avoid. In addition, environmental contractors may not be able to perform work if key personnel are not available to work due to travel restrictions, health impacts, or family obligations. Thus, the consideration of whether environmental field work should continue during the COVID-19 crisis requires weighing complex public health and safety needs and risks.
To help those considering whether and how to continue environmental field work, evaluate the following:
(1) Am I allowed to do the environmental field work under a state or local COVID-19 Restriction Order?
(2) If I cannot continue under a Restriction Order or for other reasons, how do I protect my company’s interests to avoid penalties and other liabilities under the consent decrees, administrative orders, or various other agreements with or regulations imposed by state and federal environmental agencies; and
(3) If I am allowed to or required to continue the work, what regulations pertain to how to do the work safely?
1. AM I ALLOWED TO DO THE WORK UNDER A RESTRICTION ORDER?
As of the time of publication of this alert, there are no federal mandates or executive orders requiring business shutdowns or mandatory quarantines. However, many states, counties, and municipalities are issuing executive orders closing non-essential businesses and limiting gatherings of people.
a. State-Level COVID-19 Executive Orders
Each of these state and local mandates exempt “essential businesses” and the specific definition of an essential business varies from state to state. As a general rule, however, “essential businesses” are those that promote public safety, health, and welfare. Here are examples of several of the first state directives.
California: On March 19, 2020, Governor Newsom issued Executive Order N-33-20 requiring California residents to remain at home unless they are involved in 16 critical infrastructure sectors. These 16 critical infrastructure sectors were designated by the Department of Homeland Security and include the water and wastewater systems sector that is responsible for ensuring the supply of safe drinking water and wastewater treatment and service.
Illinois: On March 20, 2020, Governor Pritzker issued Executive Order 2020-10 requiring Illinois residents to remain in their homes to prevent the spread of COVID-19. The order specifically exempts “essential government functions”, “essential businesses and operations”, and “essential infrastructure activities.” Essential infrastructure activities include operation and maintenance of utilities, including water, sewer, and gas, and solid waste and recycling collection and removal and essential businesses and operations includes construction related activities.
New York: On March 20, 2020, Governor Cuomo issued an Executive Order (referred to as Pause, standing for Policies Assure Uniform Safety for Everyone), requiring that as of 8 p.m. on March 22, all non-essential businesses must ensure that their workforce works remotely. Exempt “Essential businesses” include essential infrastructure (including utilities and construction); essential services (including trash collection, mail, and shipping services; news media; banks and related financial institutions); sanitation and essential operations of residences or other essential businesses; and vendors that provide essential services or products (including services needed to ensure the continuing operation of government agencies and provide for the health, safety, and welfare of the public).
New Jersey: On March 21, 2020, Governor Murphy issued Executive Order 107 requiring that New Jersey residents remain in their homes and requiring that all “non-essential businesses” close. A previously issued executive order (Executive Order No. 104) defined “essential businesses” to include “grocery/food stores, pharmacies, medical supply stores, gas stations, healthcare facilities and ancillary stores within healthcare facilities.” All gatherings within the state are limited to 50 persons or fewer, except for “normal operations at airports, bus and train stations, medical facilities, office environments, factories, assemblages for the purpose of industrial or manufacturing work, construction sites, mass transit, or the purchase of groceries or consumer goods.”
In addition to these states, many other states have either implemented similar orders (including Connecticut, Delaware, and Louisiana) or likely will do so in the coming weeks. While expressly mentioning critical sectors such as health care, police and fire, and grocery stores, the orders do not squarely address whether environmental field work constitutes “essential businesses” subject to these exemptions. However, environmental field work logically could be included under the categories used to describe “essential business,” particularly because many of the environmental statutes requiring such work expressly state that the work is being ordered or conducted to protect human health and the environment.
b. Federal (U.S. EPA) Environmental Agency Guidance
The White House has issued Coronavirus Response Guidelines, “15 Days to Slow the Spread,” including a statement that if you work in one of the 16 “critical infrastructure industries” as defined by the Department of Homeland Security, you have a “special responsibility” to continue to work.
As of this publication, U.S. EPA has not released public guidance on whether ongoing or new site cleanups and/or site investigations would constitute “critical infrastructure industry.” At least to some degree, that determination is likely to be a site-specific, based on the unique circumstances of each site and, as further discussed below, the language of the agency orders or agreements which govern the environmental field work. It is likely that in the coming weeks, U.S. EPA will provide further guidance on assessing whether site cleanup activities constitute “critical infrastructure industry” exempt from the various Restriction Orders. One issue that may need to be resolved in the future relates to potential conflicts in federal and state guidance regarding what constitutes an “essential service.” Such issues could be addressed via federal and state cooperation agreements in the event of possible conflicts between federal and state directives.
c. State Environmental Agency Guidance
At least one state environmental regulatory agency has provided guidance directly on this issue. On March 20, 2020, the California State Resources Water Control Board, which generally has jurisdiction over impacted groundwater in California, published a Guidance Document that states:
Please be aware that timely compliance by the regulated community with all Water Board orders and other requirements (including regulations, permits, contractual obligations, primacy delegations, and funding conditions) is generally considered to be an essential function during the COVID-19 response. As a result, the Water Boards consider compliance with board-established orders and other requirements to be within the essential activities, essential governmental functions, or comparable exceptions to shelter-in-place directives provided by local public health officials.
It is likely that similar guidance will be issued in the coming weeks by other state regulatory agencies.
2. IF I CANNOT CONTINUE THE WORK UNDER A RESTRICTION ORDER OR OTHERWISE, HOW COULD I PROTECT MY COMPANY’S INTERESTS TO AVOID PENALTIES OR OTHER LIABILITIES?
Those responsible for ongoing environmental field work should carefully evaluate the governing consent decrees, administrative orders, or other agreements with state and federal environmental agencies, and private parties, under which they are performing environmental field work. The agreements may well have force majeure and other clauses addressing delays in the work.
For example, under the current federal model remedial design/remedial action (RD/RA) judicial consent decrees with potentially responsible parties (“PRPs”) under sections 106, 107 and 122 of CERCLA, PRPs have both covenanted not to sue the United States and agreed to indemnify the same for “claims on account of construction delays.” There are additional stipulated penalty provisions. Therefore, companies must act pursuant to the force majeure provisions to avoid these claims and stipulated penalties. Force majeure is defined as “any event arising from causes beyond the control of [PRPs], of any entity controlled by [PRPs], or of [PRPs]’ contractors that delays or prevents the performance of any obligation under this [consent decree] despite [PRPs]’ best efforts to fulfill the obligation.”
Relying on these provisions involves:
Notifying “EPA’s Project Coordinator orally or, in his or her absence, EPA’s Alternate Project Coordinator or, in the event both of EPA’s designated representatives are unavailable, the Director of the Waste Management Division” in that specific U.S. EPA Region within a stipulated period of days (the period of days may vary under each consent decree).
Providing in writing to U.S. EPA “an explanation and description of the reasons for the delay; the anticipated duration of the delay; all actions taken or to be taken to prevent or minimize the delay; a schedule for implementation of any measures to be taken to prevent or mitigate the delay or the effect of the delay; [the PRP’s] rationale for attributing such delay to a force majeure; and a statement as to whether, in the opinion of [the PRP], such event may cause or contribute to an endangerment to public health or welfare, or the environment” within a stipulated period of days (the period of days likely varies under each consent decree).
Providing with the above writing “all available documentation supporting their claim that the delay was attributable to a force majeure.”
U.S. EPA is then to provide notice of its decision, which if U.S. EPA rejects the force majeure claim, the responsible parties must provide notice within 15 days of U.S. EPA’s decision to avail themselves of the model consent decree’s dispute resolution provision. The federal Model Administrative Settlement Agreement and Order on Consent for Removal Actions contains similar obligations and provisions.
It is thus plain that responsible parties conducting environmental field work should be prepared to contact U.S. EPA or state regulators orally as soon as practicable to determine their views on the necessity of the work and if there is disagreement about the same, begin to “paper the file” on the necessary force majeure documentation in the time frames provided in the governing consent decrees, administrative orders, or various other agreements with state and federal environmental agencies.
For sites that are in the early investigation stages, regulators may agree to a temporary pause in site investigations. For sites that are currently undergoing remedial measures, the determination on whether work should continue is again likely to be fact dependent. For example, a site with an ongoing groundwater treatment system that is being operated to protect a drinking water source is likely to be deemed an essential activity. For a site where the remedial measures involve excavating impacted soils that are not immediately affecting groundwater sources, it may be the case that the regulators determine that certain activities are not “essential” and can be temporarily paused or scaled back.
Even if the decision is made to proceed with the work, other circumstances may preclude or significantly impair the ability to do the work. For example, it may be difficult to obtain necessary supplies and/or vendors to perform these services. To the extent that wastes are generated in the course of doing this work, can these wastes be managed and disposed of in a timely manner? These are all issues that should be discussed with the regulators or private parties requiring the work.
3. IF I CONTINUE THE WORK, HOW CAN I DO IT SAFELY?
Once a decision is made that environmental field work is “essential” and must proceed to at least some degree, special care must be taken to ensure that the work is performed safely given additional risks imposed by COVID-19. On March 9, 2020, the federal Occupational Safety and Health Administration (“OSHA”) issued its Guidance on Preparing Workplaces for COVID-19 that was the subject of a previous client alert. This OSHA guidance outlines recommended steps that employers should take to protect workers, using OSHA’s “hierarchy of controls” framework for addressing workplace risks (i.e., engineering controls, followed by administrative controls, safe work practices, and PPE. It is also prudent for all entities at the site to consider what steps they will take if they learn that one of the workers has become exposed to the novel coronavirus or contracted COVID-19. On March 20, 2020, the CDC issued updated “Environmental Cleaning and Disinfection Recommendations.”
OSHA has long-standing regulations for work at hazardous waste sites under its Hazardous Waste Operations and Emergency Response (“HAZWOPER”) standard (in general industry 29 CFR 1910.120 and in construction 29 CFR 1926.65), which establishes health and safety requirements for work at sites, as well as responses to emergencies involving releases of hazardous substances. Many environmental investigation and remediation sites have rigorous site-specific health and safety plans, and many are required to have such plans by a consent decree or other regulatory or contractual obligation. Many environmental contractors have such plans as part of their standard operating procedures. However, given COVID-19, special care should be taken to ensure that PPE that would ordinarily be used to prevent exposure to hazardous substances is not contaminated prior to being utilized in the field. Moreover, ensuring feasible physical distancing, requiring diligent hygiene methods, and having appropriate cleaning equipment and chemicals in the field are also critical. All entities with employees at the site should regularly check both the OSHA and CDC website for updated guidance on workplace health and safety best practices. It also is important to ensure that the protocols are being appropriately communicated and followed by all entities (including regulators) at a site; the best protocols and procedures are only as good as their actual implementation by all.
OSHA has reminded the regulated community that if employees contract COVID-19 as a result of performing their work-related duties, the employees who become ill could constitute recordable cases of illness under OSHA’s Injury and Illness Recordkeeping Standard, 29 CFR Part 1904.
Companies and their counsel also should evaluate existing master services agreements that govern the work of their vendors and contractors with a particular eye towards: (i) how indemnification provisions might apply in the event that a vendor’s or contractor’s employee is later determined to be infected with COVID-19 and such a latency period could plausibly extend to such an employee’s work at the company’s site and its employees, and vice versa; and (ii) payment delay provisions should the company or its vendors or contractors become concerned about solvency issues.
We will continue to provide updates on the impacts of COVID-19 on environmental, health and safety issues affecting our clients. Jenner & Block has established a COVID-19 resource center that provides updates on a variety of issues affecting our clients and we would encourage you to visit this resource center for timely updates on COVID-19 related issues.
White House and Congress Use Liability Immunity to Address the Shortage of Respirators in Healthcare Settings
By Gabrielle Sigel, Co-Chair, Environmental and Workplace Health and Safety Law Practice
Due to COVID-19, the nation’s healthcare industry is facing a severe shortage of respiratory protection equipment for healthcare workers. Both Congress and the White House have recently taken steps to try to address that shortage by enacting liability immunity under the Families First Coronavirus Response law, signed late on March 18, 2020. These provisions protect manufacturers, distributors, and others of U.S. Food and Drug Administration (“FDA”)-designated industrial respirators from any claims of liability arising from their use during the response to COVID-19. The intent is that this would increase the supply of NIOSH-approved small-particular filtering respirators from those who manufacture or have on-hand respirators that previously had not been FDA-approved as medical devices.
As explained in OSHA’s Hospital Respiratory Protection Program Toolkit: Resources for Respirator Program Administrators (May 2015), respirators are different from facemasks, including surgical masks. Fluid-resistant facemasks are loose-fitting devices that can protect the healthcare worker from larger droplets of infectious bodily fluids from patients, and vice versa. Facemasks “are not considered respiratory protection— facemasks do NOT provide the wearer with a reliable level of protection from inhaling smaller particles, including those emitted into the room air by a patient who is exhaling or coughing, or generated during certain medical procedures.” Id. at 5. Respirators, on the other hand, protect the hospital worker from both large and small infectious particles in the air (smaller particles are known as “aerosols”). An N95 respirator is a half-mask air-purifying device with NIOSH-approved N95 filters or filtering material. The “95” refers to the NIOSH specification that the respirator filter at least 95% of airborne particles. N95 respirators can be designed for single-use or in a mask that allows re-use after replacement of N95 filter or cartridges, and, in contrast with facemasks, they are designed to form a tight seal on the user’s face. Another type of respirator that protects against inhalation of aerosols is an “air-supplying respirator,” which provides clean air from a source other than the immediate ambient air. Self-contained breathing apparatus, commonly known as “scuba equipment,” is an example of an air-supplying respirator.
Although N95 respirators are generally used in all workplaces where control of inhalation of smaller-sized particles is required to reduce hazards, in order to use such respirators in a hospital, in general, the manufacturer must have its devices approved by the Food and Drug Administration (FDA) as a medical device. Certain N95 respirators can be outfitted with the additional splash protection of a surgical mask, and are called a “surgical respirator,” “medical respirator,” or “surgical N95.” Those devices are deemed a medical device, which must be approved by both the FDA and by NIOSH for their particle-filtering ability Non-surgical N95s are not typically used in a hospital setting and a manufacturer and others may be reluctant to supply them for hospital use, particularly given the potential liability risks from their use in that setting.
Faced with a shortage of surgical N95 respirators, the White House turned to manufacturers and users of industrial N95s as an additional source. On March 2, 2020, the FDA issued an Emergency Use Authorization (EUA), pursuant to section 564 of the Food, Drug, and Cosmetic Act (FDCA), that allows the emergency, COVID-19 use of designated NIOSH-certified N95 respirators in the health care setting. The EUA also stated that certain NIOSH-approved respirators that had passed the manufacturer’s recommended shelf-life also could be used in certain circumstances.
The March 2, 2020 EUA did not address protection of industrial manufacturers from liability for use of respirators in medical settings. On March 11, 2020, the FDA clarified the EUA by stating that the FDA had deemed general use N95 respirators as medical devices within the meaning of 201(h) of the FDCA and eligible for liability protections under the Public Readiness and Emergency Preparedness Act of 2005, 42 U.S.C. § 247d-6d (“the Public Readiness Act”). Under the Public Readiness Act, certain devices, called “countermeasures,” are entitled to broad liability immunity during their use in response to a public health emergency. Specifically, a “covered person” is forever immune from liability for any type of “loss” associated with the use of a designated “countermeasure,” including death, physical, mental, or emotional injury, fear of such injury, including medical monitoring, and damage to property including business interruption. 42 U.S.C. § 247d-6d(a)(1)-(2). A “covered person” includes the United States, manufacturers and distributors of the countermeasure, and all employees of a manufacturer or distributor of a designated countermeasure. 42 U.S.C. § 247d-bd(i)(2). Liability protection is provided regardless of whether the countermeasure is sold, donated or otherwise provided and used for medical services.
On March 14, 2020, the U.S. House of Representatives passed H.R. 6201, the “Families First Coronavirus Response Act,” which in Division F, Section 6005, designated personal respiratory protective devices approved by NIOSH (42 CFR part 84) and designated by the FDA in the March 2, 2020 EUA, as a “covered countermeasure” subject to all liability immunities under the Public Readiness Act.” The U.S. Senate passed the bill, without amendment, on March 18, 2020, and later that day, the bill was signed into law by the President. Industrial respirators will remain a liability-protected countermeasure if they are used to address COVID-19 anytime between January 27, 2020 and October 1, 2024, in response to the public health emergency declared by the Secretary of Health and Human Services Alex M. Azar II on January 31, 2020.
In the meantime, as supplies continue to be short, the CDC has issued guidelines for how medical providers should triage their use of respiratory protective equipment. The guidelines issued as of March 19, 2020 are here.
EPA Announces Regulatory Determination to Regulate PFAS in Drinking Water
By Matthew G. Lawson
On Thursday, February 20, 2020, the U.S. Environmental Protection Agency (“EPA”) announced a preliminary regulatory determination that the agency will seek to implement regulatory limits for Per- and Polyfluoroalkyl Substances (PFAS) in public drinking water across the United States. The regulatory determination is a key step in the creation of a Maximum Contamination Level (“MCL”) that will act to limit the quantity of PFAS permitted in public drinking water. In its preliminary regulatory determination, EPA proposes setting MCL levels for two PFAS substances, perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), which EPA has determined meet the statutory criteria to become regulated contaminants under the Safe Drinking Water Act. To meet this criteria, EPA had to find that: (1) the consumption of PFOS and PFOA may result in adverse health effects; (2) PFOS and PFOA have been identified in public water supplies at frequencies and levels sufficient to cause a public health concern; and (3) that new regulation presents a meaningful opportunity to reduce the health risks posed by PFOS and PFOA.
As part of its announcement, EPA will seek public comments on its preliminary findings for the next 60 days. Critically, the preliminary regulatory determination offers no insight into the regulatory levels EPA anticipates setting for PFOS or PFOA. Through its voluntary Health Advisory Level (“HAL”), EPA currently recommends that municipalities maintain a maximum limit of 70 parts per trillion of PFAS in drinking water served to the public. While the HAL is referenced in EPA’s preliminary regulatory determination, it is unclear whether EPA will look to set PFOS or PFAS’ mandatorily MCL at a similar level. EPA’s election to regulate PFOS and PFOA kicks off a two-year period for the agency to determine an appropriate MCL for the contaminants. Following the formal proposal of an MCL, the agency has another 18 months to set its final drinking water requirements.
The release of a preliminary regulatory determination marks a critical step in EPA’s implementation of its PFAS Action Plan. Under the PFAS Action Plan, EPA has committed to “identifying and understanding PFAS, [ ] addressing current PFAS contamination, preventing future contamination, and effectively communicating with the public about PFAS.” The plan sets forth four overarching goals for regulating PFAS:
Consider the creation of an MCL for PFOA and PFOA;
Begin necessary steps to propose designating PFOA and PFOS as “hazardous substances” through available federal statutory mechanisms, including CERCLA, RCRA, TSCA and the CWA;
Develop and implement groundwater cleanup recommendations for PFOA and PFOS at contaminated sites;
Develop toxicity values or oral reference doses for various PFAS chemicals.
Under the Trump Administration, the EPA has repeatedly affirmed that addressing the emerging contaminant PFAS is a key and ongoing priority for the agency. As stated in the PFAS Action Plan, “the EPA has heard clearly the public’s desire for immediate action to address potential human health and economic impacts from PFAS in the environment.” In fact, despite proposing large cuts to EPA’s overall budget, the Trump Administration’s proposed budget for 2021 requests an additional $6 million dollars from Congress to carry out EPA’s PFAS Action Plan. “Under President Trump, EPA is continuing to aggressively implement our PFAS Action Plan – the most comprehensive cross-agency plan ever to address an emerging chemical,” stated EPA Administrator Andrew Wheeler. “With today’s action, EPA is following through on its commitment in the Action Plan to evaluate PFOA and PFOS under the Safe Drinking Water Act.”