U.S. EPA Issues New Rule on EPA Guidance Documents
By Steven M. Siros
On September 14, 2020, the United States Environmental Protection Agency (“U.S. EPA”) issued a final rule intended to promote transparency and establish consistent requirements and procedures for the issuance of guidance documents. Consistent with Executive Order 13891 (Promoting the Rule of Law Through Improved Agency Guidance Documents) that directs federal agencies to finalize regulations that “set forth processes and procedures for issuance of guidance documents,” U.S. EPA’s final rule establishes internal policies and procedures for U.S. EPA’s issuance of future guidance documents and codifies the requirement that U.S. EPA maintain an internet portal that identifies all effective, active U.S. EPA guidance documents.
Under this new regulation, all active “guidance documents” shall appear on the U.S. EPA Guidance Portal. The regulation defines a “guidance document” as “an Agency statement of general applicability, intended to have future effect on behavior of regulated parties, that sets forth a policy on a statutory, regulatory, or technical issues, or an interpretation of a statute or regulation.” Any guidance document that is not posted to the Guidance Portal is not an active U.S. EPA guidance document and will have no effect except to establish historical facts. However, it is important to note the Guidance Portal is only intended to identify documents meeting the definition of “guidance documents,” and documents falling outside of this definition that are not posted to the Guidance Portal may still be in effect.
The new regulation also provides for public notice and comment for “significant guidance documents,” defined as guidance documents determined to be “significant” pursuant to Executive Order 12866 and Executive Order 13891 and includes guidance documents that would have an annual effect on the economy in excess of $100 million or that raise novel legal or policy issues. The regulation provides that U.S. EPA would seek a significance determination from the Office of Information and Regulatory Affairs pursuant to Executive Order 12866.
Finally, the new regulations establish procedures to allow the public to petition U.S. EPA for modification and/or withdrawal of any active guidance document posted on the Guidance Portal. In addition, in response to comments that the new rule will allow U.S. EPA to quietly rescind previously issued guidance by simply not posting the guidance on the Guidance Portal, the new regulations also establish a formal mechanism to allow the public to request that a rescinded guidance document be reinstated and added to the Guidance Portal.
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.”
Virginia Issues First COVID-19 Emergency Workplace Safety and Health Standard
By Leah M. Song
On July 27, 2020, Virginia became the first state to adopt an emergency workplace safety standard regarding exposure to COVID-19. Virginia is one of the 22 states which has jurisdiction to issue its own workplace safety and health regulations, which must be at least as stringent as regulations issued by U.S. OSHA, but can go beyond federal requirements. The Virginia regulation titled §16 VAC 25‐220, Emergency Temporary Standard, Infectious Disease Prevention: SARS‐CoV‐2 Virus That Causes COVID‑19 (“Emergency Standard”) was adopted during a meeting of the Virginia Safety and Health Codes Board on July 15, 2020. The Emergency Standard will expire “(i) within six months of its effective date, upon expiration of the Governor’s State of Emergency, or when superseded by a permanent standard, whichever occurs first, or (ii) when repealed by the Virginia Safety and Health Codes Board.” The Emergency Standard was available as of July 24, 2020, but will be formally published on July 27, 2020, and its legal effective date is July 27, 2020.
The Emergency Standard shall apply to every employer, employee, and place of employment in Virginia within the jurisdiction of the Virginia Occupational Safety and Health Program (“VOSH”), as described in §§ 16 VAC 25-60-20 and 16 VAC 25-60-30 for both public and private employers.
The “[a]pplication of this [Emergency Standard] to a place of employment will be based on the exposure risk level” (i.e., “very high,” “high,” “medium,” and “lower” of COVID-19 and “related hazards present or job tasks.” The Emergency Standard includes a minimum list of factors to be considered in determining exposure risk level, such as the work environment and employee contact, as well as employer requirements for each exposure risk level.
The Emergency Standard details mandatory requirements for all employers, regardless of exposure risk level, such as:
- Exposure assessment and determination, notification requirements, and employee access to exposure and medical records
- Return to work policies and procedures
- Physical distancing
- Limited access to common areas
- Compliance with respiratory protection and personal protective equipment standards
- Compliance with sanitation and disinfection standards
The Emergency Standard details additional requirements for each exposure risk level designated as “very high,” “high,” and “medium.” For all workplaces other than those with low exposure risk, the employer must develop and implement a written Infectious Disease Preparedness and Response Plan (“IDPR Plan”). The IDPR Plan, employers shall consider contingency plans for outbreaks, identify basic infection prevention measures, and address interaction with outside businesses.
In addition, the Emergency Standard requires that in workplaces in the “very high” and “high” exposure risk levels, the employer shall implement protective measures such as isolation facilities and physical barriers. For the “medium” exposure risk level, the employer shall consider protective measures such as flexible work arrangements and increasing physical distancing.
With regard to face coverings, the Emergency Standard defines “face covering” as not PPE. The Emergency Standard states: “Employee use of face coverings for contact inside six feet of coworkers, customers, or other persons is not an acceptable administrative or work practice control to achieve minimal occupational contact. However, when it is necessary for an employee to have brief contact with others inside the six feet distance a face covering is required.” §16 VAC 25‐220-30. At the “medium” exposure level, employers of "medium" exposure level workplaces are required, “to the extent possible,” to provide and have their employees wear face coverings where it is not feasible to physically distance between employees or in customer-facing jobs for the “medium” exposure level. Face coverings may not be required under certain circumstances, such due to the wearer’s medical condition and religious waivers.
To the extent that an employer actually complies with a recommendation contained in CDC guidelines, and those guidelines provide “equivalent or greater protection than provided by a provision of this [Emergency Standard], the employer’s actions shall be considered in compliance with this [Emergency Standard].” “An employer’s actual compliance with a recommendation contained in CDC guidelines … shall be considered evidence of good faith in any enforcement proceeding related to this [Emergency Standard].”
The Emergency Standard also expressly addressed the notification requirements when there is an employee with a positive COVID-19 case. Employers must notify (a) the building or facility owner if any employee in the building tests positive for COVID-19; (b) the Virginia Department of Health within 24 hours of the discovery of a positive case; and (c) the Virginia Department of Labor and Industry within 24 hours of the discovery of three or more employees who test positive for COVID-19 within a 14-day period.
Additionally, employers are prohibited from using antibody testing to “make decisions about returning employees to work who were previously classified as known or suspected to be infected” with COVID-19.
The Emergency Standard also confirms an employee’s right to “refus[e] to do work or enter a location that the employee feels is unsafe.” Section 16 VAC 25-60-110 provides requirements regarding the “discharge or discipline of an employee who has refused to complete an assigned task because of a reasonable fear of injury or death.” That provision states that such discharge or discipline will be considered retaliatory “only if the employee has sought abatement of the hazard from the employer and the statutory procedures for securing abatement would not have provided timely protection.”
Under Emergency Standard §16 VAC 25‐220‐80, covered employers will have until August 26, 2020, to train employees, covering topics such as the requirements of the Emergency Standard, COVID-19 symptoms and methods of transmission, safe and healthy work practices, and anti-discrimination provisions. It is important to note that training requirements for exposure risk levels “very high,” “high,” and “medium” differ from the less-comprehensive requirements for the “lower” risk level. Under subsection 16 VAC 25‐220‐70, if an employer is required to have an IDPR Plan, the employer must develop and train employees on their IDPR Plan by September 25, 2020.
Training and outreach materials, including training PowerPoints, FAQs, an IDPR Plan template, and an exposure risk level flow chart, are being developed by the VOSH Cooperative Programs Division, with some available here, as of July 24, 2020.
At the federal level, OSHA has come under scrutiny for its decision not to adopt a COVID-19 emergency temporary standard. The American Federation of Labor and Congress of Industrial Organizations’ (“AFL-CIO”) and other unions asked OSHA to issue an Emergency Temporary Standard (“ETS”), rather than have employers rely solely on existing OSHA regulations and new COVID-19 guidance to no avail. On May 18, 2020, the AFL-CIO filed a petition for a writ of mandamus in the U.S. Court of Appeals to compel OSHA to issue an ETS within 30 days. However, on June 11, 2020, the court held that “OSHA reasonably determined that an ETS is not necessary at this time” given 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 environment.” On June 18, 2020, the AFL-CIO filed for a rehearing en banc. Please see Jenner & Block’s analysis of the AFL-CIO lawsuit here. In addition, the U.S. House of Representatives introduced legislation, titled “The COVID-19 Every Worker Protection Act” (H.R. 6559), which would require OSHA to issue an ETS. The provisions of H.R. 6559, including the provisions relating to the ETS, were included in H.R. 6800, The Heroes Act. H.R, passed by the House on May 15, 2020, and which is set to be part of the upcoming political debates and votes by the House and the Senate on new COVID-19 economic stimulus and related legislation.
Jenner & Block’s Corporate Environmental Lawyer will continue to update on these matters, as well as other important COVID‑19 related guidance, as they unfold.
Lawsuits Challenging EPA’s Temporary Enforcement Discretion Policy for COVID‑19 Pandemic Hit Dead End
By Leah M. Song
As an update to our July 1st blog regarding EPA’s notice that its COVID-19 Temporary Enforcement Policy will end on August 31, 2020, there have been some new developments in the lawsuits filed challenging that policy.
On July 8, 2020, Judge McMahon of the United States District Court for the Southern District of New York ruled that the Natural Resources Defense Counsel and other environmental organizations (“Plaintiffs”) failed to show that they were injured by EPA’s purported “unreasonable delay” in responding to the petition. The Plaintiffs had petitioned EPA to publish an emergency rule requiring an entity to provide written notice if they were suspending monitoring and reporting because of COVID-19.
The court held that the Plaintiffs failed to establish the standing requirements. The Plaintiffs did not establish that they were “legally entitled to the information they seek” and lacked association standing as well. The Plaintiffs did not demonstrate that they “suffered a sufficiently concrete injury nor that that alleged injury is fairly traceable to EPA’s purported delay in responding to the Petition.”
The court said it was “perfectly obvious that, at the time Plaintiffs brought this lawsuit, the EPA had not ‘unreasonably’ delayed its response to the Petition.” Judge McMahon said that “the real litigation – over the legality of the [Enforcement Policy] itself – is presently being briefed in an action brought by nine State Attorneys General. That is where the action will – and should – take place.” Accordingly, the court granted summary judgment in favor of the EPA.
One day later on July 9, the State Attorneys General indicated that they will drop their lawsuit against EPA given the upcoming Enforcement Policy deadline. “EPA does not intend to extend the [Enforcement] Policy beyond August 31 and, should the policy terminate on (or before) August 31, Plaintiffs currently intend to voluntarily dismiss the Complaint without prejudice.” The parties prepared a “contingent, expedited briefing schedule” should EPA not terminate the Enforcement Policy by that date. This announcement this lawsuit will be is unlikely to cause Judge McMahon to revisit the summary judgment ruling since this decision doesn’t change that Plaintiffs lacked standing to bring the claims.
Jenner & Block’s Corporate Environmental Lawyer will continue to update on these matters, as well as other important COVID‑19 related guidance, as they unfold.
PFAS SNUR Finalized Without “Safe Harbor” Provisions
By Steven M. Siros
On June 22, 2020, U.S. EPA issued a final TSCA significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances. Specifically, the SNUR designates as a significant new use manufacturing (including importing) or processing of (i) an identified subset of LCPFAC chemical substances for any use that was not ongoing as of December 15, 2015 and (ii) for all other LCPFAC chemical substances for which there were no ongoing uses as of January 21, 2015.
The SNUR also makes inapplicable the exemption for persons who import LCPFAC chemical substances as part of the surface coating on articles (note that the SNUR narrows the scope of affected articles from all imported articles to only those articles that contain such a substance in a surface coating). The SNUR also makes inapplicable the exemption for persons who import PFAS chemical substances in carpets. Persons subject to this SNUR would be required to provide notification to U.S. EPA prior to manufacturing or importing these chemical substances which notification would trigger U.S. EPA’s TSCA review and evaluation of the intended use.
The final SNUR did drop two controversial provisions that would have provided a “de minimis” exemption below which notification would not be required and a “safe harbor” provision that would have allowed article importers to avoid enforcement action if they could demonstrate that their use was ongoing prior to the rule’s effective date.
In response to comments submitted on the proposed “safe harbor” provisions, U.S EPA noted that “[a] safe harbor approach undermines the regulatory process for what uses are allowed by permitting a manufacturer to claim a use was ongoing at the time the SNUR was issued” especially since manufacturers and/or importers were put on notice of the proposed SNUR five years ago.
With respect to the proposed “de minimis” threshold for articles before the notification requirements would kick in, U.S. EPA noted while it was not establishing a de minimis threshold in the final rule, U.S. EPA stated that it “will, however, continue to engage with interested stakeholders on this issue and continue to consider whether guidance for applying this standard may be appropriate in the future, whether as a general matter or, for instance, as applied to specific categories of substances or potential exposures.”
The SNUR will take effect 60 days after official publication in the Federal Register.
U.S. Court of Appeals Denies AFL-CIO’s Petition for OSHA COVID-19 Emergency Temporary Standard
By Leah M. Song and Gabrielle Sigel
On June 11, 2020, the U.S. Court of Appeals for the D.C. Circuit denied the American Federation of Labor and Congress of Industrial Organizations’ (“AFL-CIO”) petition for a writ of mandamus to compel OSHA to issue an Emergency Temporary Standard for Infectious Diseases (“ETS”), providing regulations to protect workers against coronavirus exposure in the workplace.
The three-judge panel, consisting of Judges Henderson, Wilkins, and Rao, found that “OSHA reasonably determined that an ETS is not necessary at this time” given 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, see 29 U.S.C. § 654(a).” The statutory section referenced by the court, includes the General Duty Clause of the Occupational Safety and Health Act (“the OSH Act”), which states that each employer “shall furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees.” 29 U.S.C. § 654(a)(1). The statute also requires that each employer shall “comply with occupational safety and health standards promulgated under this Act.” 29 U.S.C. § 654(a)(2). The panel held that “OSHA’s decision not to issue an ETS is entitled to considerable deference.”
Following the Court’s ruling, Solicitor of Labor Kate O’Scannlain and OSHA Principal Deputy Assistant Secretary Loren Sweatt stated in a news release: “We are pleased with the decision from the D.C. Circuit, which agreed that OSHA reasonably determined that its existing statutory and regulatory tools are protecting America’s workers and that an emergency temporary standard is not necessary at this time. OSHA will continue to enforce the law and offer guidance to employers and employees to keep America’s workplaces safe.” The ALF-CIO has the right to ask for a rehearing, including en banc, i.e., by all the judges appointed to the D.C. Circuit Court of Appeals.
The lawsuit grew out of written requests that the AFL-CIO and more than 20 unions, including unions for healthcare workers, sent to OSHA in early March. They asked OSHA to issue an ETS, rather than have employers rely solely on existing OSHA regulations and new COVID-19 guidance. They requested an ETS that would include a requirement that all employers devise and implement an infection control plan and implement the necessary controls. After the AFL-CIO sent a letter on April 28, 2020, to the Secretary of Labor calling on the agency “to take immediate action to protect the safety and health of workers from exposure to COVID-19 on the job,” the Secretary responded two days later and stated that an ETS was not necessary.
On May 18, 2020, the AFL-CIO filed its petition for a writ of mandamus in the U.S. Court of Appeals to compel OSHA to issue an ETS within 30 days. The petition was based on Section 6(c) of the OSH Act, which states that OSHA “shall provide…for an emergency temporary standard to take immediate effect upon publication in the Federal Register if [it] determines (A) 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 (B) that such emergency standard is necessary to protect employees from such danger.” 29 U.S.C. § 655(c)(1). The AFL-CIO argued in its court petition that the COVID-19 pandemic is “exactly the type of workplace catastrophe that Congress intended an emergency temporary standard to address.” Given the risks facing essential workers and those returning to work, the AFL-CIO requested an expedited briefing and disposition of the petition and for OSHA to be given 10 days to respond.
On May 29, 2020, OSHA filed its response to the AFL-CIO’s petition, describing its efforts to protect workers during the pandemic through enforcing “existing rules and statutory requirements” and providing “rapid, flexible guidance.” OSHA emphasized the extreme nature of an ETS and how an ETS is rarely used as it “imposes a mandatory standard immediately without public input” and “stays in place…until a permanent rule informed by comment is put in place just six months later.” OSHA argued that 1) the AFL-CIO failed to demonstrate legal standing to bring the petition for a writ of mandamus; 2) an ETS is not “necessary” given OSHA’s existing specific rules, the general duty clause and would otherwise be counterproductive to OSHA’s COVID-19 efforts; and 3) “an ETS would foreclose ongoing policy assessments by the executive branch, Congress, and the states.” The National Association of Home Builders of the United States and other business associations filed amicus curiae briefs in support of OSHA’s position.
On June 2, 2020, the AFL-CIO filed its reply brief defending its legal standing to bring the case based on its representation of workers in highly impacted industries and that at least 660 of its members have died as a result of COVID-19. The AFL-CIO continued to stress that an ETS is necessary given the “urgent situation” and “grave danger” that COVID-19 presents. Additionally, the AFL-CIO stated that “Congress required OSHA to issue standards despite inevitable scientific uncertainty,” and an ETS does provide flexibility navigating new scientific information since “an ETS can be issued and modified without notice and comment.” The AFL-CIO clarified that the OSH Act requires the agency to issue an ETS, “not that it requires a static, uniform, or all-encompassing ETS.”
In denying AFL-CIO’s petition, the court did not address OSHA’s standing argument, ruling solely on the substance of AFL-CIO’s petition.
Of note, OSHA regulations do not have direct application to the 22 states who have their own state occupational safety and health agencies and regulations governing private employers. One of those “state plan states” is California. On May 20, 2020, the Labor & Employment Committee of the National Lawyers Guild and Worksafe, a California nonprofit “dedicated to ensuring occupational safety and health rights of vulnerable workers,” filed a petition for a temporary emergency standard before the California Occupational Safety & Health Standards Board (“the Board”). The petitioners requested that the Board create two new California safety regulations. First, the petitioners requested “a temporary emergency standard that would provide specific protections to California employees who may have exposure to COVID-19, but are not protected by the Aerosol Transmissible Diseases standards (Sections 5199 and 5199.1).” The petitioners recommended that the Board consider their draft emergency temporary standard for the Board’s consideration of language for an emergency standard. The petitioners’ draft parallels the framework of the Injury and Illness Prevention Program, but adding COVID-19 related provisions, such as identifying an employee representative, establishing various procedures, and analyzing job hazards and implementing preventative measures. Second, the petitioners requested that the Board enter into “a permanent rulemaking effort to protect workers from infectious diseases including novel pathogens,” such as COVID-19. As of June 11, 2020, the Board has not yet issued its decision on the petition.
Please feel free to contact the authors with questions or for further information. 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.
The Ninth Circuit Sends Climate Change Cases Back to State Court
By Leah M. Song
On May 26, 2020, the Ninth Circuit agreed with plaintiffs that two climate change lawsuits—County of San Mateo v. Chevron Corp. et al. and City of Oakland v. BP p.l.c. et al.—had been improperly removed to the federal courts, continuing courts’ recent trend of remanding these types of cases back to state court.
A growing form of climate change litigation in the United States consists of lawsuits filed by states or municipalities against private industry, and more specifically, the fossil-fuel industry. States, cities and other units of local government have filed lawsuits alleging state common law theories, including nuisance, trespass, failure to warn of the known impacts of climate change, and unjust enrichment. The outcome of these cases thus far has hinged on whether or not the fossil fuel companies are able to successfully remove the litigation to federal court where they stand a much greater chance of getting the litigation dismissed. Generally, plaintiffs (including states, units of local government, and non-governmental organizations) asserting climate change claims against corporations prefer to be in state court where they can take advantage of perceived plaintiff-friendly common law or state statutes. On the other hand, defendants inevitably seek to remove such cases to federal court where they have had a higher level of success securing dismissals on the grounds that the issue is preempted by the Clean Air Act and/or addresses a “political question” which is better left to the discretion of Congress. See City of N.Y. v. BP P.L.C.. 325 F. Supp. 3d 466 (S.D.N.Y. 2018).
In County of San Mateo v. Chevron Corp. et al., six California municipalities and counties sued more than 30 fossil-fuel companies in California state court. The plaintiffs brought a variety of claims under state common law including nuisance, negligence, failure to warn, and trespass. In City of Oakland v. BP p.l.c. et al., the Cities of Oakland and San Francisco sued five fossil-fuel companies in state court under a theory of nuisance. The fossil-fuel companies removed both cases to federal court. The San Mateo district court remanded the case back to state court while the Oakland district court refused to remand the case back to state court, finding that plaintiffs’ public nuisance claims were governed by federal common law, but then proceeding to dismiss the lawsuit. Both cases were appealed to the Ninth Circuit.
On May 26th, the Ninth Circuit joined the Fourth Circuit (Mayor and City Council of Baltimore v. BP P.L.C., et al., No. 19-1644 (4th Cir. Mar. 6, 2020)) in concluding that these climate change cases alleging only state-common law claim belonged in state court. In County of San Mateo v. Chevron Corp. et al., the Ninth Circuit emphasized its limited authority to review an order remanding a case back to state court under 28 U.S.C. § 1447(d). The Ninth Circuit therefore limited its review to determining whether the district court erred in holding that the federal court lacked subject matter jurisdiction under the federal-officer removal statute.
In order to determine whether the district court erred in holding that it did not have subject matter jurisdiction, the Ninth Circuit examined whether the companies were “acting under” a federal officer’s directions. The companies argued that they were “persons acting under” a federal officer based on several agreements with the government. However, the Ninth Circuit concluded that the companies’ activities under these agreements did not give rise to a relationship where they were “acting under” a federal officer. Accordingly, the Ninth Circuit court held that the fossil fuel companies failed to meet their burden for federal-officer removal and therefore affirmed the district court’s remand order.
In City of Oakland v. BP p.l.c. et al., the Ninth Circuit considered whether “the district court erred in determining that it had federal-question jurisdiction under 28 U.S.C. § 1331” and ultimately held that plaintiffs’ state common-law public nuisance claims did not arise under federal common law. The court acknowledged that there are exceptions to the well-pleaded complaint rule for claims that arise under federal law, but concluded that none of those exceptions applied here.
The court reasoned that “[t]he question whether the Energy Companies can be held liable for public nuisance based on production and promotion of the use of fossil fuels and be required to spend billions of dollars on abatement is no doubt an important policy question, but it does not raise a substantial question of federal law for the purpose of determining whether there is jurisdiction under § 1331.” Furthermore, evaluation of the public nuisance claim would require factual determinations which are “not the type of claim for which federal-question lies.” The fossil fuel companies argued that the plaintiffs’ public nuisance claim was completely preempted by the Clean Air Act, but the court was not persuaded.
In response to defendants’ argument that by amending their complaint to assert a federal common law claim, the district court properly had subject matter jurisdiction under 28 U.S.C. § 1331, the Ninth Circuit noted that plaintiffs only amended their complaint in response to the district court’s statements that plaintiffs’ claims were governed by federal common law. Moreover, the Ninth Circuit noted that since a party violates § 1441(a) “if it removes a cases that is not fit for federal adjudication, a district court must remand the case to state court, even if subsequent action conferred subject-matter jurisdiction on the district court.”
Notwithstanding these conclusions, the Ninth Circuit noted that the district court had not addressed alternative bases for removal raised by defendants and therefore remanded the case back to the district court. However, the Ninth Circuit specifically noted that if the district court concludes that there are no valid bases for federal jurisdiction, the case should be remanded back to state court.
Although these rulings did not address the merits of plaintiffs’ common-law claims, these cases will certainly pose challenges for defendants seeking to remove these types of cases to federal court, and will likely affect plaintiffs’ and defendants’ strategies in climate change litigation moving forward. Jenner & Block’s Corporate Environmental Lawyer will continue to update on those matters, as well as other important climate change litigation cases, as they unfold.
New Executive Order Presses Agencies to Continue to Seek Regulatory Flexibility in Response to the Covid-19 Pandemic
By Leah M. Song
On May 19, 2020, the President issued an executive order titled “Regulatory Relief to Support Economic Recovery” (“Executive Order”). The Executive Order seeks to “overcome the effects the virus has had on [the] economy” and to that end, directs agencies and executive departments to "continue to remove barriers to the greatest engine ever known: the innovation, initiative and drive of the American people." To do so, executive departments and agencies are encouraged and directed to take appropriate action.
The Executive Order directs agencies to respond to the economic consequences of COVID‑19 by “rescinding, modifying, waiving, or providing exemptions from regulations and other requirements that may inhibit economic recovery.” Agencies are directed, "to use, to the fullest extent possible and consistent with applicable law, any emergency authorities” to support the economic response to COVID-19. Agencies are charged with identifying “regulatory standards that may inhibit economic recovery” and take appropriate action to promote job creation and economic growth. This includes issuing proposed rules, exempting persons or entities from requirements, exercising appropriate temporary enforcement discretion or temporary time extensions.
The Executive Order further instructs agencies to provide compliance assistance for regulated entities and to “accelerate procedures by which a regulated person or entity may receive a pre-enforcement ruling.” Agencies should consider enforcement discretion policies for those that “have attempted in reasonable good faith to comply with applicable statutory and regulatory standards.” Additionally, the Executive Order emphasized that agencies should “consider the principles of fairness” and “revise their procedures and practices in light of them.” The Executive Order recommends that agencies review regulatory standards and “determine which, if any, would promote economic recovery if made permanent.”
Consistent with this Executive Order, the Environmental Protection Agency (“EPA”) has previously issued a COVID-19-related policy regarding EPA's decision to exercise enforcement discretion with respect to non-compliance with certain environmental requirements (this enforcement policy was the subject of a prior Corporate Environmental blog). Although EPA's enforcement discretion policy has been challenged by several states and environmental organizations, the Executive Order would seem to diminish the likelihood that EPA will rescind its enforcement discretion policy in the near term.
Please feel free to contact the author with questions or for further information. 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.
U.S. EPA Extends Comment Period on PFAS Safe Drinking Water Act Regulatory Determination to June 10, 2020
By Steven M. Siros
As discussed in more detail in a previous blog, on February 20, 2020, the U.S. Environmental Protection Agency (“U.S. EPA”) announced that it was seeking public comments on its preliminary regulatory determination that seeks 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, U.S. 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, U.S. 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.
The Association of Metropolitan Water Agencies and the American Water Works Association (collectively “AMWA”) submitted comments that were supportive of setting an MCL for PFOS and PFOA. In addition to targeting PFOA and PFOS, the AMWA recommended that U. S. EPA also include four other long-chain PFAS compounds in its regulatory determination. AMWA also recommended that U.S. EPA “thoroughly consider state standards and guidelines with significantly lower PFAS levels that [U.S. EPA’s] Health Advisory Level (HAL) of 70 parts per trillion (ppt) for combined concentrations of PFOA and PFOS.”
The AMWA also requested that U.S. EPA extend the comment period an additional 30 days to allow the AMWA to more fully engage with its members and to provide more meaningful and comprehensive comments on the proposal. To that end, U.S. EPA has now agreed to extend the comment period an additional 30 days May 10th to June 10th.
EPA’s Temporary Enforcement Discretion Policy for COVID-19 Pandemic
By Leah M. Song and Steven M. Siros
On March 26, 2020, the U.S. Environmental Protection Agency (“EPA”) announced a temporary policy regarding EPA enforcement of environmental legal obligations during the COVID-19 pandemic. EPA Administrator Andrew Wheeler stated that the “EPA is committed to protecting human health and the environment, but recognizes challenges resulting from efforts to protect workers and the public from COVID-19 may directly impact the ability of regulated facilities to meet all federal regulatory requirements.”
This temporary enforcement discretion policy applies to civil violations during the COVID-19 outbreak. To clarify, the policy does not apply to: a) any criminal violations or conditions of probation in criminal sentences, b) activities that are carried out under Superfund and RCRA Corrective Action enforcement instruments, and c) imports. Additionally, the policy does not relieve any entity from preventing, responding to, or reporting accidental releases.
The temporary policy makes it clear that the EPA expects regulated facilities to comply with regulatory requirements, where reasonably practicable, and to return to compliance as quickly as possible. To be eligible for enforcement discretion, the policy also requires facilities to document decisions made to prevent or mitigate noncompliance and demonstrate how the noncompliance was caused by the COVID-19 pandemic.
The policy addresses different categories of noncompliance differently and is broken into the following sections:
Routine Compliance Monitoring and Reporting by Regulated Entities
Facilities should use existing procedures to report noncompliance with routine activities, such as compliance monitoring, integrity testing, sampling, laboratory analysis, training, and reporting or certification. If reporting is not reasonably practicable due to COVID-19, facilities should maintain this information internally and make it available to EPA upon request. In general, the EPA does not expect to seek penalties for violations of such routine activities where the EPA agrees that COVID-19 was the cause of the noncompliance and the entity provides supporting documentation to the EPA upon request.
Additionally, the EPA does not plan to ask facilities to “catch-up” with missed monitoring or reporting if the underlying requirement applies to intervals of less than three months. For other monitoring or reports, such as those required on a bi-annual or annual basis, when this policy is no longer in effect, the EPA expects facilities to take reasonable measures to resume compliance activities as soon as possible, including conducting late monitoring or submitting late reports, and encourages facilities to provide supporting documentation in the reporting form.
Given the online availability of trainings, the EPA does not think trainings will be affected. If training is not practicable due to COVID-19, the EPA believes that it is more important to keep experienced, trained operators on the job, even if a training or certification is missed.
EPA does expect continued submissions, certifications or required reports or other deliverables, but will exempt the requirement to obtain a “wet” signature, and will accept a digital or electronic signature. EPA strongly encourages use of approved electronic reporting mechanisms.
Settlement Agreement and Consent Decrees Reporting Obligations and Milestones
Parties to EPA administrative settlement agreements should utilize the notice procedures set forth in the agreement if the parties anticipate missing enforceable milestones. The notification should provide the information required by the agreement, which typically will include steps taken to minimize the effects and duration of any noncompliance caused by COVID-19.
Consent decrees entered into with the EPA and the U.S. Department of Justice (“DOJ”) remain under the jurisdiction of the courts. The EPA staff will coordinate with the DOJ to exercise enforcement discretion with regard to stipulated penalties for the routine compliance obligation. Again, parties should utilize the notice procedures set forth in the consent decree.
The EPA expects all regulated entities to continue to manage and operate their facilities in a manner that is safe and that protects the public and the environment.
Facilities should contact the appropriate implementing authority if facility operations impacted by COVID-19 may create an acute risk or an imminent threat to human health or the environment. In response, the EPA will work with the appropriate authority to discuss measures to minimize or prevent the acute or imminent threat to health or the environment from the COVID-19-caused noncompliance and obtain a return to compliance as soon as possible.
If a facility suffers from failure of air emission control or wastewater or waste treatment systems or other facility equipment that may result in exceedances of enforceable limitations, the facility should notify the implementing authority as quickly as possible. The notification also should include information on the pollutants emitted, discharged, discarded, or released; the comparison between the expected emissions or discharges, disposal, or release and any applicable limitation(s); and the expected duration and timing of the exceedance(s) or releases.
If facility operations result in noncompliance are not already addressed by the EPA above, the facility should do its best to prevent or mitigate noncompliance and document such efforts.
If a facility is a generator of hazardous waste and, due to disruptions caused by the COVID-19 pandemic, is unable to transfer the waste off-site within the time periods required under RCRA to maintain its generator status, the facility should continue to properly label and store such waste. If the facility does its best to prevent or mitigate noncompliance, the EPA will treat such entities to be hazardous waste generators.
Lastly, if a facility is an animal feeding operation, and, due to disruptions caused by the COVID-19 pandemic, is unable to transfer animals off-site and, solely as a result of the pandemic, meets the regulatory definition of concentrated animal feeding operation (“CAFO”), the EPA will not treat such animal feeding operations as CAFOs.
Public Water Systems Regulated Under the Safe Drinking Water Act
The EPA has heightened expectations for public water systems. The EPA expects operators of such systems and laboratories performing analysis for water system to continue normal operations, maintenance, and timely analysis of samples and results.
The EPA will consider continued operation of drinking water systems to be the highest priority. The EPA considers the following tiers of compliance monitoring: 1) National Primary Drinking Water Regulations, 2) nitrate/nitrite and Lead and Copper Rule, and 3) contaminants for which the system has been non-compliant.
The EPA strongly encourages public water systems to consult with the state and EPA regional offices without delay if issues arise that prevent the normal delivery of safe drinking water.
In situations where a facility is essential critical infrastructure, the EPA may consider, on a case-by-case basis, a more tailored short-term No Action Assurance if it is in the public interest. The EPA will consider essential the facilities that employ essential critical infrastructure workers as determined by guidance issued by the Cybersecurity and Infrastructure Security Agency.
EPA’s policy will apply retroactively beginning on March 13, 2020. EPA will assess the continued need for and scope of this temporary policy on a regular basis and will update it if EPA determines modifications are necessary. EPA will post a notification here at least 7 days prior to terminating this temporary policy.
Jenner & Block’s "Corporate Environmental Lawyer" will continue to update on these matters, as well as other important COVID-19 related guidance, as they unfold.
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.
Supreme Court Agrees to Hear Key Endangered Species Act FOIA Case
By Matthew G. Lawson
On Monday, March 2, 2020, the United States Supreme Court granted certiorari to a petition from two U.S. federal agencies attempting to block the release of certain agency decision-making documents under the Freedom of Information Act (“FOIA”). The agencies’ petition followed a determination by the Ninth Circuit that certain “draft” documents created by the agencies pursuant to Section 7 of the Endangered Species Act (“ESA”) were not exempt from public release under FOIA. The Supreme Court’s resolution of the matter is expected to have far reaching impacts on the types of documents that federal agencies may hold back from public release under FOIA.
The case stems from an April 2011 regulatory proposal by U.S. EPA to modify standards related to certain “cooling water intake structures,” used by power plants and manufacturing facilities to dissipate heat. Under Section 7 of the ESA, the United States Fish and Wildlife Service (“USFWS”) and National Marine Fisheries Service (“NMFS”) were required to provide U.S. EPA their “biological opinions” as to whether the regulatory proposal was “likely to cause jeopardy” for certain ESA-listed species or negatively impact critical habitat of threatened or endangered species. Pursuant to this obligation, the USFWS and NMFS advised U.S. EPA of their preliminary determination that the proposed regulations would harm currently endangered species. However, the agencies’ preliminary determinations were never published, and following further discussions with U.S. EPA, the agencies ultimately modified their conclusion and announced a finding that the proposed regulations would pose no “no jeopardy” to endangered species. Following this determination, the Sierra Club subsequently issued a FOIA request for documents related to the ESA consultation process, but the agencies refused to turn over documents related to their draft preliminary determination. Specifically, the agencies claimed that the documents were protected under the “deliberate process privilege” exception to the FOIA. Following several years of litigation, the Ninth Circuit held in 2018 that the deliberate process privilege did not extend to block the draft documents created by the USFWS and NMFS and that the agencies were required to turn over the documents to the Sierra Club.
In its petition, the Government urged that the Ninth Circuit’s rulings must be overturned in order to protect the deliberate process privilege of FOIA, which is essential for “promoting a candid exchange within and between agencies before a final decision is made.” In its brief in response to the Government, the Sierra Club argued that the documents “conveyed the Services’ conclusion that a particular action proposed by…EPA would result in jeopardy to species protected by the ESA,” and that the agencies’ attempt to subsequently identify these documents as “drafts” did alter the conclusive nature of the documents.
The Supreme Court’s decision to hear the Government’s petition is likely an ominous indicator for the Sierra Club and other environmental groups supporting the Ninth Circuit’s holding. Since 2007, the Supreme Court has overturned approximately 70% of the federal circuit decisions it agrees to review, and has overturned more than 77% of the decisions arriving from the Ninth Circuit.
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.”