On May 4, Jenner & Block Partner Steven M. Siros and Associate Leah M. Song will present a CLE webinar on environmental, health, and safety (EHS) issues facing the cannabis industry. The market value of the cannabis industry in the United States is expected to reach $30 billion by 2025. Currently, 36 states allow the use of cannabis for medicinal purposes and 15 states allow the recreational use of cannabis. To sustain this rapid industry growth, and avoid potential penalties and lawsuits, it is crucial that cannabis companies ensure consistent compliance with EHS rules and regulations.
In this CLE Program, Mr. Siros and Ms. Song will cover the particular EHS challenges that the cannabis industry currently faces, including issues related to emissions, water resources, waste regulation, and pesticides. The program will also address worker safety issues and the state and federal OSHA regulations cannabis operations are subject to as well as post-consumer issues cannabis companies face such as packaging issues and recycling. Please email firstname.lastname@example.org if you are interested in attending. Space is limited.
Mr. Siros is chair of the Environmental Litigation Practice and co-chair of the Environmental Workplace Health & Safety Law Practice. He focuses primarily on environmental and toxic tort matters.
Ms. Song is an associate in the firm’s Environmental and Workplace Health & Safety Law Practice.
By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
A key platform of President Biden’s environmental agenda is increased regulatory scrutiny with respect to chemical substances under the Toxic Substances Control Act (TSCA). Regulating chemicals in order to minimize the threat to human health and the environment is clearly also critical to achieving the aims and goals of Earth Day, especially considering that the publication of Rachel Carson’s Silent Spring helped spark the global environmental movement that eventually culminated in the first Earth Day in 1970.
Turning now to the present, in the waning months of the Trump administration, there was a flurry of U.S. EPA activity under TSCA, including the issuance of risk evaluations for a number of high-priority chemical substances, including asbestos, 1,4-dioxane, and trichloroethylene. Notwithstanding that these risk evaluations concluded that at least some uses of each of the ten high priority chemicals posed an unreasonable risk, these risk evaluations were widely criticized for failing to take into consideration reasonably foreseeable uses or failing to adequately consider various scientific studies. There had been much speculation that President Biden would reject all of the Trump-era TSCA risk evaluations and in fact, one of President Biden’s first actions in the White House was to direct U.S. EPA to review the TSCA risk evaluation process as well as the methylene chloride risk evaluation specifically.
Rather than throwing the baby out with the bathwater, however, U.S. EPA is moving forward to develop risk mitigation plans for each of these high priority chemicals. At the same time, Michal Freedhoff, the acting assistant administrator for U.S. EPA’s Office of Chemical Safety and Pollution, noted that U.S. EPA would be taking a hard look at these risk evaluations. In a prepared statement, Ms. Freedhoff stated:
Our goal is to allow risk management actions on these first ten chemicals to move forward as much as possible, while looking back surgically at specific areas in some of the risk evaluations to supplement them as appropriate in order to ensure we are meeting our statutory obligations and using the best available science to truly protect human health and the environment.
As to the next 20 chemicals in the risk assessment pipeline, U.S. EPA has already announced that it will reassess its TSCA risk evaluation process, including refining its approach for selecting and reviewing scientific studies. U.S. EPA noted that it would not rely on U.S. EPA’s Application of Systematic Review in TSCA Risk Evaluations, a guidance document issued by U.S. EPA in 2018 that was much maligned by the National Academy of Scientists.
One can also expect an increased focus on environmental justice issues by U.S. EPA in connection with evaluating the risks posed by chemical substances. This will most likely play out in connection with an increased focus on chemical substance exposure for fence-line and front-line communities during the risk evaluation process.
Finally, there will also be increasing pressure on the Biden Administration to regulate new emerging contaminants such as per- and polyfluoroalkyl substances (PFAS) under both TSCA and the Safe Drinking Water Act. PFAS compounds have not yet been considered for prioritization under TSCA but are likely to be on a list of high priority chemicals in the future. In the meantime, U.S. EPA is likely to move forward with designating at least PFAS compounds as hazardous substances under CERCLA as well as evaluating whether to set an MCL for these compounds under the Safe Drinking Water Act.
Please check back on Jenner & Block’s Corporate Environmental Lawyer for more Earth Day content throughout the week.
By: Todd C. Toral and PJ M. Novack
Lawsuits over alleged misleading environmental marketing claims, or “greenwashing,” are nothing new. It has been nearly 30 years since the Federal Trade Commission (FTC) released its first version of the “Green Guides,” which are intended to help marketers avoid the practice. Since then, there have been many greenwashing actions before the FTC. More broadly, the FTC has pursued a number of suits in federal court, such as false advertising claims over the terms “clean diesel” and “100% organic.” But last month, in a first, several environmental groups petitioned the FTC to use its Green Guides offensively against a fossil fuel company for “misleading consumers on the climate and environmental impact of its operations.”
On March 16, 2021, Earthworks, Global Witness, and Greenpeace USA filed a complaint against Chevron for misleading consumers through advertisements that exaggerate the company’s investment in renewable energy and its commitment to reducing fossil fuel pollution. The action comes on the heels of Chevron’s new “Climate Change Resilience” report, where Chevron outlined its contributions against climate change. The environmental groups argue that Chevron misrepresents its image to appear climate-friendly and racial-justice oriented, while actually doing more harm than good. In support of their claims, the environmental groups point out that Chevron is the second most polluting company in the world and had spent only 0.2% of its capital expenditures on low-carbon energy sources between 2010-2018.
Considering the recent change in administrations, this action may represent a new trend where consumer and environmental groups are willing to take on major oil companies by petitioning a potentially more consumer-friendly FTC. President Biden currently has an opportunity to fill the vacant FTC seat and tip the balance of power toward Democrats. Moreover, President Biden has signaled his personal support for environmental causes by halting oil and gas sales and canceling the Keystone XL crude pipeline. Given the shifting sands, companies should be prepared for new and perhaps more creative enforcement actions.
By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
Breaking from the pack and potentially creating a circuit split, the Second Circuit’s decision in City of New York v. Chevron, et al. dismissing New York’s City’s climate change lawsuit is a significant victory for the oil and gas industry. The unanimous ruling from the Second Circuit affirmed a district’s court decision dismissing New York’s common law claims, finding that issues such as global warming and greenhouse gas emissions invoked questions of federal law that are not well suited to the application of state law.
Taking a slightly different tact than state and local plaintiffs in other climate change lawsuits, the State of New York sued five oil producers in federal court asserting causes of action for (1) public nuisance, (2) private nuisance, and (3) trespass under New York law stemming from the defendants’ production, promotion and sale of fossil fuels. New York sought both compensatory damages as well as a possible injunction that would require defendants to abate the public nuisance and trespass. Defendants filed motions to dismiss that were granted. The district court determined that New York’s state-law claims were displaced by federal common law and that those federal common law claims were in turn displaced by the Clean Air Act. The district court also concluded that judicial caution counseled against permitting New York to bring federal common law claims against defendants for foreign greenhouse gas emissions.
The Second Circuit agreed with the district court, noting that the problems facing New York can’t be attributed solely to greenhouse gas emissions in the state nor the emissions of the five defendants. Rather, the greenhouse gas emissions that New York alleges required the City to launch a “$20 billion-plus multilayered investment program in climate resiliency across all five boroughs” are a byproduct of emissions around the world for the past several hundred years.
As the Second Circuit noted, “[t]he question before it is whether municipalities may utilize state tort law to hold multinational oil companies liable for the damages caused by greenhouse gas emissions. Given the nature of the harm and the existence of a complex web of federal and international environmental law regulating such emissions, we hold that the answer is ‘no.’”
Finding that New York’s state common law claims were displaced by federal common law, the Second Circuit then considered whether the Clean Air Act displaced these federal common law claims. The Second Circuit noted that the Supreme Court in Am. Elec. Power Co. v. Connecticut (AEP) (2011) had previously held that the “’Clean Air Act and the EPA actions it authorizes displace any federal common-law right to seek abatement’ of greenhouse gas emissions.” As to the State’s damage claims, the Second Circuit agreed with the Ninth Circuit’s reasoning in Native Vill. Of Kivalina v. Exxonmobil Corp. (9th Cir. 2012) that the “displacement of federal common law does not turn on the nature of the remedy but rather on the cause of action.” As such, the Second Circuit held that “whether styled as an action for injunctive relief against the Producers to stop them from producing fossil fuels, or an action for damages that would have the same practical effect, the City’s claims are clearly barred by the Clean Air Act.
The Second Circuit was careful to distinguish its holding from the holdings reached by the First, Fourth, Ninth and Tenth circuits in prior climate change cases, noting that in those other cases, the plaintiffs had brought state-law claims in state court and defendants then sought to remove the cases to federal courts. The single issue in those cases was whether defendants’ federal preemption defenses singlehandedly created federal question jurisdiction. Here, because New York elected to file in federal as opposed to state court, the Second Circuit was free to consider defendants’ preemption defense on its own terms and not under the heightened standard applicable to a removal inquiry.
Whether the Second Circuit’s decision has any impact on BP PLC, et al. v. Mayor and City Council of Baltimore, a case that has now been fully briefed and argued before the Supreme Court remains to be seen. The Baltimore case was one of the state court cases discussed above that was removed to federal court. The defendants had alleged a number of different grounds for removal, one of which is known as the “federal officer removal statute” that allows removal to federal court of any lawsuit filed against an officer or person acting under that office of the United States or an agency thereof. The limited issue before the Supreme Court was whether the appellate court could only consider the federal-officer removal ground or whether it could instead review any of the grounds relied upon in defendants’ removal petition.
Some commenters have noted that the Second Circuit’s decision creates a circuit split that may embolden the Supreme Court to address these climate change cases in one fell swoop. The more likely scenario, however, is that the Supreme Court limits its opinion to the narrow issue before it and leaves resolution of whether state law climate change nuisance actions are preempted by federal law for another day.
The North Carolina Department of Environmental Quality (DEQ) is continuing to investigate an unexplained source of per-fluorinated compounds (PFAS) contamination that may be associated with the deployment of a fire-fighting compound in response to a major gasoline release by the Colonial Pipeline system on August 14, 2020. The Colonial Pipeline, which spans 5,500 miles from Houston, Texas, to Linden, New Jersey, runs through a number of southern and mid-Atlantic states, including North Carolina. The active pipeline delivers an average of 100 million gallons of liquid petroleum products each day. On August 14, 2020, a leak in the pipeline resulted in the release of approximately 1.2 million gallons of gasoline into the environment near the town of Huntersville, North Carolina. The release was the largest onshore gasoline spill in the United States in over 20 years and in connection with Colonial Pipeline’s emergency response to that release, Colonial Pipeline sprayed a commonly used fire suppressant known as F-500 encapsulate on the contaminated land to minimize the risk that vapors from the release would ignite.
However, following Colonial Pipeline’s initial emergency response, new questions have emerged regarding PFAS that was detected at the release site. As part of the ongoing efforts to investigate the nature and extent of the gasoline release, DEQ directed Colonial Pipeline to collect samples from the F-500 encapsulate and test that encapsulate for various PFAS formations. The resulting test data found elevated levels—as high as 22,600 parts per trillion (“ppt”)—of at least three different PFAS compounds. Samples of a nearby surface water showed PFAS concentrations ranging from 1 ppt to 14.9 ppt.
The source of the PFAS is not readily apparent, however, because as verified by the Safety Data Sheet , F-500 is not known to contain PFAS compounds. In fact, F-500 acts differently than aqueous film forming foam (AFFF) to fight fires. AFFF is intended to separate oxygen from the fuel while F-500 works by removing the heat, neutralizing the fuel, and interrupting the free radical chain reaction. As such, it does not rely on fluorine compounds for effectiveness.
It is possible that the source of the PFAS identified by Colonial Pipeline was a result of residual AFFF residing in the storage tank or in the fire-fighting equipment that was used to dispense the F-500 encapsulating agent. The F-500 was transported to the site by the Pelham Alabama fire department and the fire-fighting equipment that sprayed the F-500 was supplied by the Hunterville Fire Department. However, notwithstanding that the equipment was supplied by the municipal fire departments and that the F-500 is not known to contain PFAS compounds, DEQ has still requested that Colonial Pipeline provide data demonstrating that there have been no PFAS impacts to soil or groundwater as a result of the emergency response.
This a cautionary tale for environmental health and safety professionals charged with maintaining emergency spill response materials, including fire suppressant products, for their respective organizations. Such professionals are faced with a unique challenge of ensuring that products maintained for spill containment or remediation purposes are not only fit for these purposes, but also that these products do not contain chemicals that pose a potential threat to human health or the environment. This challenge is particularly acute with PFAS, of which there are over 5,000 different formulations which can be found in a large variety of different consumer and industry products. Even if a decision is made to swap out one product that may historically contained PFAS with a new product that is purportedly PFAS-free, care should be taken to ensure that product distribution equipment is PFAS-free. Otherwise, one might find oneself in the unfortunate position of having to defend against claims relating to PFAS impacts in the environment.
On October 8, 2020, the Conservation Law Foundation filed a lawsuit challenging a DOJ policy that barred the use of supplemental environmental projects (SEPs) in federal enforcement settlements with private parties. SEPs have been used since the 1980s and typically involve a project intended to provide some tangible environmental or public health benefit that could not necessarily be compelled by U.S. EPA.
DOJ, in a March 12, 2020 memorandum, announced that it was terminating its policy of allowing companies to agree to perform SEPs in exchange for reductions in civil penalties in environmental enforcement settlements. According to DOJ, the practice of using SEPs in lieu of civil penalties violates the Miscellaneous Receipts Act, a statute that prevents cash from legal settlements being diverted from the Treasury to third parties. As further described in the March 2020 DOJ memorandum, DOJ claims that the SEPs basically substitute payments to third parties for payments to the Treasury, circumventing Congress’ Constitutional power of the purse.
The lawsuit claims that DOJ’s conclusion that the use of SEPs violates the Miscellaneous Receipts Act is arbitrary and capricious and otherwise lacks reasoned decision-making. The lawsuit highlights U.S. EPA’s history of using SEPs and its various guidance documents encouraging the use of SEPs in environmental enforcement matters. The lawsuit asks that the Court declare that DOJ’s March 2020 memo violates the Administrative Procedures Act, vacate the memo, and enjoin DOJ from implementing or relying on the memo in the future. .
We will continue to provide updates on this lawsuit as well as other important environmental, health and safety issues on Jenner & Block’s Corporate Environmental Lawyer Blog.
On August 30, 2020, the California legislature passed the Toxic Free Cosmetics Act making California the first state to ban certain chemicals from cosmetics. Governor Newson signed the bill into law on October 1, 2020. The new law amends existing regulatory programs in California and provides that cosmetics containing any of a specific list of 24 chemicals will be considered “adulterated” and therefore unable to be sold in California. The specific list of chemicals includes certain phthalates and formaldehyde. However, the chemicals that have received the most attention are various per- and polyfluoroalkyl (PFAS) substances. Although some states have previously implemented legislation banning certain chemicals in cosmetic products (Minnesota banned formaldehyde in certain children’s personal care products; Washington requires that certain chemicals in children’s products be reported), California has become the first state to implement such a broad ban on these listed chemicals in cosmetics generally.
The ban will take effect on January 1, 2025 providing companies with time to take the necessary steps to eliminate any of the 24 listed chemicals from their cosmetic products. Of course, many companies have already taken steps to eliminate these chemicals from their products especially since many of these chemicals are already on California’s Proposition 65 list. However, unlike with Proposition 65 where compliance can be demonstrated by the provision of the requisite warnings, the Toxic Free Cosmetics Act will require elimination of these chemicals (with the exception of unavoidable trace quantities).
We will continue to provide regulatory updates as more states are likely to follow California’s lead in regulating these chemicals in various personal care products.
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
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?
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.
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.”
White House Promises to Use “All Available Tools” to Implement Deep Cuts to EPA Funding in Fiscal Year 2021
On Monday, February 10, 2020, the Trump Administration released its proposed budget for Fiscal Year 2021. The proposal calls for sweeping cuts to a number of federal agencies and departments, including deep cuts to the United States Environmental Protection Agency (“USEPA”). If enacted, the proposed budget would grant $6.7 billion in funding to USEPA, a $2.4 billion or 26-percent reduction from the agency’s $9.1 billion budget in 2020. In the budget proposal’s preamble, the Administration promises to “call on the Government to reduce wasteful, unnecessary spending, and to fix mismanagement and redundancy across agencies.”
With respect to USEPA’s budget allocation, the proposal promises to “eliminate almost 50 wasteful programs that are outside of EPA’s core mission or duplicative of other efforts, saving taxpayers over $600 million.” Proposed major cuts include the reduction of nearly 50% of the agency’s research budget, including all funding for grants to independent universities and research institutes conducting air, water, and other environmental and health research. Another target for deep cuts is USEPA’s safe drinking water revolving funds. The revolving funds are used to help fund water infrastructure projects undertaken by state or municipal public water providers. Under the proposed budget, the available funds for such projects would be cut from approximately $2.77 billion down to $2 billion.
While the proposal primarily focuses on proposing cuts to USEPA’s fiscal budget, it does contain a few line item requests for additional funding. In particular, the proposal asks for an additional $6 million to carry out USEPA’s Per- and Polyfluoroalkyl Substances (PFAS) Action Plan. The additional funding is sought to continue research into the risk posed by PFAS compounds, address current contamination issues, and effectively communicate findings to the public. In addition, the budget requests $16 million into new research to help prevent and respond to the rising growth of harmful algal blooms.
The budget proposal is not the first time the Trump Administration has sought to implement deep cuts into USEPA’s budget. In fact, the Trump Administration has now proposed nearly identical cuts to the agency’s budget in each of the last three fiscal years. As previously discussed by the Corporate Environmental Lawyer, the Trump Administration first proposed a $2.7 billion budget reduction for USEPA in fiscal year 2018. However, the proposal was rebuffed by congress and the final spending bill ultimately signed by Trump held the agency’s budget at $8.1 billion, even with its 2017 level. The following year, the Trump Administration again proposed cutting the agency’s budget by more than $2 billion, but ultimately agreed to a spending deal that increased the agency’s budget to $8.8 billion. Finally, during fiscal year 2020, the Trump Administration proposed approximately $2.7 billion in cuts to USEPA’s budget. As before, Congress rejected the proposal and ultimately approved a nearly record high budget for USEPA of $9.1 Billion. Congress’ continued rejection of the spending cuts proposed by the Trump Administration is acknowledged in the Administration’s most recent 2021 budget proposal, which derides Congress for continuing “to reject any efforts to restrain spending” and “greatly contribut[ing] to the continued ballooning of Federal debt and deficits, putting the Nation’s fiscal future at risk.” The proposal promises that the Trump Administration will use “all available tools and levers” to ensure that the spending reductions outlined in the budget are finally implemented.
On February 6, 2020, California’s Water Resources Control Board (WRCB) announced that it would be dropping the response levels (RLs) for perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) from 70 parts per trillion (ppt) to 10 ppt for PFOA and 40 ppt for PFOS. This announcement comes on the heels of the WRCB’s August 2019 decision to lower the notification levels (NLs) for these compounds to 5.1 ppt for PFOA and 6.5 ppt for PFOS. An exceedance of the NL requires that the drinking water provider notify their governing boards and the WRCB of the exceedance—this notification would need to occur within 30 days of receipt of the validated laboratory results. In the event of an exceedance of the RL, the water provider must either (1) take the source out of service immediately; (2) utilize treatment or blending; or (3) provide public notification of the exceedance within 30 days of receipt of the validated laboratory results.
At the same time, the WRCB has asked California’s Office of Environmental Health Hazard Assessment (OEHHA) to proceed with the development of public health goals for both PFOA and PFOS which is a step in the process of establishing maximum contaminants levels for these contaminants. We will continue to monitor and provide updates with respect to these ongoing regulatory activities.
In a consent decree filed in the United States District Court for the Western District of Michigan, Wolverine World Wide, Inc. (“Wolverine”) has agreed to pay up to $69.5 million to resolve claims that it was responsible for PFAS contamination found in drinking water in the Michigan townships of Plainfield and Algoma. The consent decree alleges that Wolverine’s historical operations utilized PFAS to waterproof clothing and that these operations resulted in PFAS releases that impacted local drinking water supplies in these Michigan townships. Although Wolverine disputes these allegations, in the consent decree, Wolverine agreed that it would (1) remediate the PFAS impacts at its historical operations and (2) provide alternative drinking water supplies for approximately 1,000 properties within the zone of PFAS impacted groundwater.
Trump Administration Proposes Landmark Changes to National Environmental Policy Act’s Review Process
Marking the 50th anniversary of the enactment of the National Environmental Policy Act (“NEPA”), on January 1, 2020, the Trump White House published a Presidential Message announcing the imminent release of newly proposed regulations designed to “modernize” the foundational environmental statute. NEPA, which requires federal agencies to quantify and consider environmental impacts before undertaking actions that have the potential to “substantially impact” the environment, has far reaching applications. Under NEPA, federal agencies are often required to complete an Environmental Impact Assessment (“EIS”) prior to starting public infrastructure projects such as roads, bridges and ports, or before permitting certain private actions that require federal approval, such as construction of pipelines or commencement of mining operations. According to the 2018 Annual NEPA Report, EISs drafted by federal agencies between 2010 and 2017 took an average of 4.5 years to complete. The Presidential Message asserts that the existing NEPA review process “has become increasingly complex and difficult to navigate,” while causing “delays that can increase costs, derail important projects, and threaten jobs for American workers and labor union members.” The regulations proposed by the Trump Administration are expected to be released by the Council on Environmental Quality (“CEQ”) later this week.
If enacted, the proposed regulations could mark the first comprehensive update to NEPA’s review process in more than four decades. According to accounts of a draft memo from CEQ outlying the proposed changes, the modifications will bring substantial changes to the NEPA review process, including:
In recent years, the global maritime shipping industry has faced pressure to reduce the large quantity of greenhouse gas (“GHG”) emissions associated with international shipping. About 90 percent of the world’s trade goods are transported by ship, and, according to one 2014 study, the shipment of these good via maritime vessels emits approximately 1.9 billion tonnes of GHG annually, or approximately 4% of human-made emissions worldwide. The annual GHG output of the shipping industry has been projected to rise by as much as 250% by 2050 if direct actions are not taken to modify industry practices.
Because of its international nature, global shipping is extremely difficult to regulate on a national basis, and therefore is often addressed through international agreements. To this end, in 2018, the International Maritime Organization (“IMO”), a branch of the United Nations, approved the world’s first broad agreement designed to reduce GHG from worldwide ocean shipping. The agreement reached by the IMO member provides the following target metrics:
(1) Reduce CO2 emissions per “transport work” (product of cargo transmitted and distance sailed) by at least 40% by 2030 and 70% by 2050; and
(2) Reduce total CO2 emissions from shipping by at least 50% by 2050.
The targets were designated to fall in line with the GHG reductions goals set out in the 2015 Paris Climate Accords (the "2015 Paris Agreement"). Though the 2015 Paris Agreement does not include an agreement to reduce GHGs in international shipping, the IMO has stated that it is committed to reducing GHGs in the industry to match the commitment put forward in the agreement.
On December 18, 2019, ship owner associations representing over 90% of the world’s merchant fleets formally presented to IMO their proposed strategy for meeting the international body’s 2018 GHG reduction goals. The industry’s plan proposed the creation of a $5 Billion USD research fund that will be used to research and develop more environmentally friendly fuels and ship propulsion systems. The fund would be fully funded from a $2 per ton tax on marine fuel purchased by shippers over a 10-year period. The associations argued that the fund would be critical to the development of alternative fuels—such as synthetic fuels created by renewable energy sources—which had the potential to drastically reduce the industry’s carbon footprint.
IMO’s environmental goals expand to areas beyond just GHG reduction. For example, in January 2020, the IMO’s new cap on the amount of Sulphur permitted fuel oil will take effect. The effort is aimed at reducing maritime vessel’s emissions of Sulphur oxides (SOx), which are known to be harmful to human health and can lead to acid rain and ocean acidification. on December 10, 2019, the United States Environmental Protection Agency (“USEPA”) enacted a new Final Rule to help refiners comply with the IMO’s new global sulfur standard. As provided by the USEPA, the Final Rule was designed to “ensure that U.S. refiners can permissibly distribute distillate marine fuel up to the 5,000 ppm sulfur limit, which will facilitate smooth implementation of the 2020 global marine fuel standard.”
By Leah M. Song
Following a three-week bench trial, the New York Supreme Court ruled in favor of Exxon Mobil Corp. in the climate fraud case brought by New York’s attorney general, who accused the energy company of deceiving its investors about climate change-related risks to its business. In reaching this holding, Justice Barry Ostrager found that the attorney general “failed to prove, by a preponderance of the evidence, that ExxonMobil made any material misstatements or omissions about its practices and procedures that misled any reasonable investor,” which was the threshold for sustaining claims under the Martin Act.
As noted in Jenner & Block’s previous blog post, the attorney general began its investigation into Exxon Mobil in 2015. The attorney general’s investigation was grounded in New York's shareholder-protection statute, the Martin Act, as well as New York’s consumer protection and general business laws. After a three-year investigation, the attorney general’s office sued Exxon on October 24, 2018.
Exxon Mobil’s victory was foreshadowed when the attorney general dropped two of its four claims, one for common law fraud and one for equitable fraud, on the last day of trial. These claims were important to the state’s case because they alleged that Exxon Mobil’s misstatements were part of a scheme to mislead its investors and that Exxon Mobil’s investors had in fact relied on the misstatements when purchasing the company’s stock. Only two Martin Act investor fraud claims remained, which did not require the government to prove fraudulent intent.
An Exxon spokesperson said the ruling affirmed the position Exxon has held throughout the investigation and trial. "The court agreed that the attorney general failed to make a case, even with the extremely low threshold of the Martin Act in its favor," the spokesperson said.
Despite ruling against the attorney general, Judge Ostrager clarified that “nothing in [the] opinion is intended to absolve ExxonMobil from responsibility for contributing to climate change through the emission of greenhouse gases in the production of its fossil fuel products.” The judge continued “ExxonMobil is in the business of producing energy, and this is a securities fraud case, not a climate change case.”
Exxon is battling similar accusations in other state and federal courts. 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.
The Senate in a 70-15 vote confirmed Dan Brouillette this week as the new Secretary of Energy to succeed Secretary Rick Perry. All 47 Republicans who were present for the vote backed confirmation, as did 22 Democrats, including Joe Manchin III of West Virginia, Tom Udall of New Mexico, and Richard J. Durbin of Illinois, and one Independent, Angus King of Maine.
At his confirmation hearing, Mr. Brouillette stressed the role of the DOE in advancing research, including focusing his tenure on pushing direct air capture, carbon capture and sequestration (CCS), nuclear reactors, and the DOE commercialization work that fosters novel technologies in the private sector. He stated he would “absolutely” devote more DOE resources to researching DAC, and praised ongoing work on CCS and demonstrations of the technology in Wyoming in particular, nothing that he is “very excited about the work I see being done in Wyoming and within DOE writ large.”
Wyoming has become a focal point of the tension as to the future of coal under climate change policies or other environmental laws and the potential opportunity for CCS to resolve this tension. (Wyoming supplies 40% of the United States’ coal to 29 states.) The Wyoming Public Service Commission Chair has recently spoke about the need for a hard look at the benefits of CCS before shuttering coal plants. Also this week, the University of Wyoming announced a partnership with DOE to accelerate research on carbon capture technology at two of the state’s coal-fired power plants. In light of Mr. Brouillette’s extensive comments in support of Wyoming and CCS, we can anticipate much more on this front.
As noted by the New York Times, before becoming deputy energy secretary, Mr. Brouillette was chief of staff to the House Energy and Commerce Committee and was assistant secretary of energy for congressional and intergovernmental affairs in the George W. Bush administration. He also worked as an executive at the United Services Automobile Association, a financial services provider to members of the military, and Ford Motor Company. He once was a member of Louisiana’s State Mineral and Energy Board.
On November 25, 2019, U.S. EPA submitted an advance notice of proposed rulemaking (ANPR) for publication in the Federal Register seeking public comment on whether certain per- and polyfluoroalkyl substances (PFAS) should be added to the list of chemicals subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). In its ANPR, U.S. EPA seeks comments on which, if any, PFAS compounds should be considered for listing, how to list them, and what would be the appropriate reporting thresholds given their persistence and bioaccumulation potential. U.S. EPA specifically notes that it is considering establishing a reporting threshold for PFAS that is lower than the usual statutory thresholds (25,000 pounds for manufacturing or processing and 10,000 pounds for otherwise using listing chemicals) due to concerns over the compounds environmental persistence and bioaccumulation potential. The ANPR notes that perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) have been the most widely studied PFAS compounds but notes that there are more than 600 PFAS compounds that are being manufactured and/or used in the United States.
If added to the list of chemicals subject to reporting under EPCRA, affected companies would be required to report annually how much of each listed PFAS compound is released into the environment or otherwise managed through energy recovery, recycling or treatment. This information is then publicly available through the Toxic Release Inventory database. The ANPR comes on the heels of action by the House Energy and Commerce Committee that approved legislation (H.R. 535) on November 20th that seeks to add at least 13 PFAS compounds to the list of chemicals subject to EPCRA reporting.
In conjunction with a publicity blitz surrounding the release of “Dark Waters,” a movie targeting alleged environmental and health impacts associated with PFAS releases in Ohio and West Virginia, a group of environmental groups, lawmakers and other advocates of more stringent PFAS regulations launched a public clearinghouse that is intended to provide consumers with information on the adverse health impacts of PFAS and provide recommendations on ways to minimize exposure to these chemical substances. In a November 19, 2019 press conference, Mark Ruffalo (one of the actors in the "Dark Waters" movie) and Rob Bilott (author of the book Exposure), joined by members of Congress and several environmental groups, announced the launch of the clearinghouse, named “Fight Forever Chemicals,” noting that purpose behind the clearinghouse is to bring the fight against forever chemicals from the margins to the mainstream and thereby demand stronger protections from leaders in office.
As has been discussed in previous blog entries, both the States and U.S. EPA are feeling increasing pressure to adopt stringent PFAS regulations. Some states such as California have already adopted screening levels as low as 5 parts per trillion for perfluorooctanoic acid (PFOA) in drinking water (and suggested that the levels could be as low as 0.1 parts per trillion), even though the science regarding the toxicity of these compounds is still in flux. On November 21, 2019, U.S. EPA released its fall regulatory agenda in which it confirmed its intent to designate PFOA and perfluorooctanesulfonic acid (PFOS) as hazardous substances through one of the available statutory mechanisms in Section 102 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).
The publicity surrounding the launch of the clearinghouse and the opening of the movie will only increase the pressure felt by States and U.S. EPA. As such, it is more important than ever for companies to ensure that they have carefully thought-out strategies in place to minimize the risks associated with PFAS impacts in the environment. These strategies need to take into consideration the allocation of PFAS risks in transactional settings, as well as assessing potential liabilities associated with historical manufacturing operations. The PFAS tidal wave seems to building, and companies should be proactive to guard against being caught up in the deluge.
Recent DOJ Directive Marks Continuing Effort to Curb Availability of Supplemental Environmental Projects in Civil Environmental Settlements
On August 21, 2019, the Department of Justice issue a new memorandum reducing state and local governments’ ability to enter into settlement agreements that require the completion of supplemental environmental projects (SEPs) as compensation for alleged environmental violations. While impactful in its own right, the DOJ memo can be viewed as a continuation of an over two-year long effort by the DOJ to reduce the general availability of SEPs in the settlement of civil environmental cases.
As defined by the EPA, “SEPs are projects or activities that go beyond what could legally be required in order for the defendant to return to compliance, and secure environmental and/or public health benefits in addition to those achieved by compliance with applicable laws.” Private parties or municipalities may offer to complete SEPs as part of a settlement with EPA or other environmental regulators. By doing so, the alleged violator effectively replaces a part or all of the penalty owed for an environmental violation with the commitment to develop an environmentally beneficial project.
Despite the widespread and longstanding use of SEPs in settlement agreements, recent actions by the DOJ demonstrate a clear effort by the Department to reduce the use of SEPs in the settlement of alleged environmental violations.
Available Company Defenses to Climate Change Shareholder Activism: Trends in Climate Change Litigation, Part 5
As noted in Jenner & Block’s prior blog post, Shareholder Activism: Trends in Climate Change Litigation, Part 4, an emerging issue for public companies in high greenhouse gas (“GHG”) emitting industries is increased pressure from environmentally focused “activist shareholders.” These shareholders often seek to leverage their ownership shares to influence companies into taking action to decrease GHG emissions and/or increase public disclosure of such emissions. These efforts may be undertaken through negotiations with company management or through the introduction of specific shareholder proposals and proxy materials to be presented and voted on at annual shareholder meetings.
Several recent actions taken by the SEC may now help shield public companies from certain attempts by shareholders to introduce climate change related proposals for consideration at shareholder meetings. Under SEC rule 14a-8(i)(7), public companies may exclude from shareholders’ voting ballots any proposals which seek to “micromanage” the company’s ordinary business operations. In recent months, the SEC has asserted that rule 14a-8(i)(7) may be utilized by companies to block certain types of climate change related proposals. The agency has articulated this position by issuing “no-action” letters to public companies seeking to block climate-change proposals from their shareholders. In effect, these letters act as an assurance that the SEC will not recommend enforcement action against the companies for blocking the respective proposals because the agency agrees that the proposal falls under the purview of rule 14a-8(i)(7). However, the SEC has, in a few instances, refused to issue “no-action” letters to companies seeking to block shareholder climate change proposals.
Whether a shareholder’s climate change proposal is excludable under rule 14a-8(i)(7) therefore appears to be a case-by-case determination which depends on the specific demands of a proposal. As a general rule, the SEC has found that proposals which only seek greater disclosure of a company’s GHG emissions cannot be excluded under rule 14a-8(i)(7), but proposals which impose GHG emission reduction targets on the company or require specific methods for reporting or calculating GHGs may be excluded under rule 14a-8(i)(7). A few instructive examples of these general conclusions are provided below:
- On February 14, 2019, the SEC issued a no-action letter to J.B. Hunt Transport Services, Inc. approving the company’s request to block a shareholder proposal that, if implemented, would require the company to adopt quantitative targets for reducing GHG emissions and issue a report demonstrating its progress towards achieving these targets. The SEC found that the proposal sought to micromanage the business by probing into complex matters that were better left to the informed judgment of management.
- On March 4, 2019, the SEC refused to issue a no-action letter to Anadarko Petroleum Corporation after the company sought to block a proposal requesting that the company describe if, and how, it planned to reduce its total contribution to climate change to fall in line with the global temperature objectives of Paris Agreement.
- On April 2, 2019, the SEC issued a no-action letter to ExxonMobil which affirmed that the company could exclude a shareholder proposal which would require the company to adopt and disclose certain GHG emission reduction targets. The SEC noted that the proposal sought to replace the ongoing judgments of the company’s management with “specific methods” for implementing complex policies.
Of course, the threat of potential governmental enforcement actions is only one reason why a company may hesitate to block shareholder proposals. Beyond the business considerations of such a decision, public companies may also need to consider whether adopting certain types of shareholder proposals—particularly those calling for increased disclosure and transparency of GHG emissions—may be beneficial to protect the company from the risk of future lawsuits by the company’s shareholders.
How Low Will The Regulators Go: California Sets New PFOA/PFOS Drinking Water Notification Guidelines
On August 23, 2019, California’s State Water Resources Control Board (Water Board) announced updated guidelines for local water agencies with respect to perfluorooactanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) in drinking water. The updated guidelines lower the notification levels from 14 parts per trillion (ppt) to 5.1 ppt for PFOA and from 13 ppt to 6.5 ppt for PFOS. Public water supply systems are required to report exceedances of these guidelines to their governing boards and the Water Board.
According to the Water Board, these new guidelines were predicated on updated health recommendations issued by California’s Office of Environmental Health Hazard Assessment (OEHHA), which published its own recommended notification levels for PFOA and PFOS, albeit at much lower levels. In a recently issued report, OEHHA recommended that the notification levels be set at 0.1 ppt for PFOA and 0.4 ppt for PFOS. However, OEHHA recognized that these levels are lower than what can reasonably be detected in the laboratory and therefore recommended that the Water Board set the notification levels at the lowest reliable detection levels.
In addition to the updated notification levels, the Water Board requested that OEHHA proceed to develop public health goals for both PFOA and PFOS, which is the next step in the process of establishing maximum contaminant levels for these contaminants in drinking water. We will continue to monitor and provide updates with respect to these regulatory efforts.
Exploring the E-Suite with Elizabeth Anderson, Ph.D., Fellow ATS, Chief Science Officer and Senior Fellow, Exponent, Inc.; formerly, Carcinogen Assessment Group and Office of Health and Environmental Assessment, U.S. EPA
Exploring the E-Suite with Elizabeth Anderson, Ph.D., Fellow ATS, Chief Science Officer and Senior Fellow, Exponent, Inc.; formerly, Carcinogen Assessment Group and Office of Health and Environmental Assessment, U.S. EPA
- I understand that you worked for U.S. EPA when it was first started as a federal agency in the early 1970s. What was your role at the “new” U.S. EPA?
I led the health sciences assessment work for the first 14 years after U.S. EPA was formed in December 1970. At the time, U.S. EPA was a very small agency. I was the only health scientist in an eight-person Office of Technical Analysis, reporting directly to U.S. EPA’s first Administrator, Bill Ruckelshaus. He is an extraordinary person—a terrific and committed leader, who also knew how to make hard work fun. The Administrator asked me to lead an intra-agency committee to write a cancer policy to address the zero risk tolerance expectation for substances with some evidence, often conflicting, of carcinogenicity, as indicated by tumors in animals or humans. Another challenge was that substances could be ubiquitous or important to our society. We knew a “zero tolerance” policy for all possible carcinogens would be unworkable, so my committee reported out a process rather than a cancer policy. That process was the first use of risk assessment to organize what is known and unknown about the likelihood that exposure to a particular agent might cause illness. On the assumption the agent might cause illness, the next step is to define what levels of risk and exposure would be acceptable and protective of public health. The concept of risk acceptance was novel at the time and was introduced in a social and political climate aimed at seeking the ideal, i.e., zero risk.
My office at U.S. EPA conducted and I co-authored more than 150 risk assessments between 1976 and 1983 as a basis for defining major regulatory policy. The National Academy of Sciences published its endorsement of this risk assessment process in 1983. The Academy’s report, referred to as “The Red Book,” inspired national and international adoption of the U.S. EPA’s approach to risk assessment started by my intra-agency committee. I led the effort to expand the health assessment program, which resulted in establishing the central risk assessment office for the Agency—the Office of Health and Environmental Assessment. This office reported directly to the Administrator, who granted us wide latitude to expeditiously conduct our assessments.
- What was your professional and academic background leading to your involvement in health risk assessment?
My academic background is in synthetic organic chemistry, the chemistry of making organic molecules, amongst other applications, to be biologically active. I was pre-med at the College of William and Mary, but I was strongly discouraged from pursuing medical school “because I would be taking the place of a man” (a quote from the Chairman of the Chemistry Department). Instead, I was granted a fellowship at the University of Virginia to pursue a master’s degree in synthetic organic chemistry. Next, I applied for a unique fellowship being granted by the U.S. Department of Defense and completed my Ph.D. work in synthetic organic chemistry. During those early years of U.S. EPA, my degree and training best fit the Agency’s needs. There were no degrees in toxicology, relevant applications in epidemiology were just emerging, and mechanism of action had received little attention. I was fortunate to be in the right place at the right time.
- What was it like to be part of the start of a new federal agency?
Most of all, it was challenging. Following the civil rights movement, the anti-Vietnam war movement, and 20 million people marching on the first Earth Day, the spirit of the time was that significant change can happen; every move at EPA was front-page news. We all felt a sense of urgency to make a difference and establish scientific credibility for all decisions that the Agency had to make. U.S. EPA inherited a rapidly cascading series of enabling legislation starting with the Clean Air Act in December of 1970, followed by amendments to the Federal Water Pollution Control Act; the Federal Insecticide, Fungicide, and Rodenticide Act; Radiation Authorities; the Drinking Water Act; “Superfund” (CERCLA); and the Resource Conservation and Recovery Act (RCRA). All compelled the Agency to be protective of public health. Implementing this Congressional directive was left to the Agency and, for our part, this meant meeting strict deadlines and establishing scientific foundations that defined protection and that could survive challenges from Congress and the scientific, private, public, and legal communities.
At a very young age, many of us at U.S. EPA inherited a great deal of responsibility. New areas of complexity seemed to develop on a daily basis. Looking back, a culture of committed, young professionals worked hard and achieved a great deal. We were inspired by the excitement and challenge of those times. Many of us have remained friends and colleagues until the present day. Some of us are still involved, as board members of the U.S. EPA Alumni Association.
- What were some of the accomplishments of which you were most proud that came out of your work for U.S. EPA?
I am proud of many things, but I am most proud of my role in co-authoring the first guidelines to establish risk assessment and risk management as the basis for setting public policy to protect public health and having the opportunity to found and direct U.S. EPA’s first health assessment offices, the Carcinogen Assessment Group, and the expanded Office of Health Environmental Assessment. In addition, I had the opportunity to found and direct the Agency’s expansion of health topics to include reproductive risk assessment, mutagen risk assessment, and exposure assessment groups; these offices conducted all risk assessments for the Agency’s program offices for many years.
I was fortunate to be a part of establishing the scholarship in this rapidly developing and complex field of health risk assessment. A small number of us founded the Society for Risk Analysis, a focal point for sharing scientific developments from all sectors, including engineering and the social sciences. I served as one of the early Presidents and, for 10 years, was Editor-in-Chief of the Society’s flagship journal, Risk Analysis: An International Journal. In addition, as U.S. EPA’s representative, I had the privilege of participating in the worldwide application of risk assessment first in Europe through the World Health Organization and subsequently through the Pan American Health Organization and other organizations.
- After you left U.S. EPA, you have had several professional engagements. Can you summarize those for us?
After spending 14 years being a part of U.S. EPA’s founding, I entered the private sector, initially as President and CEO of the first private health and environmental assessment consulting firm, Clement Associates. In addition to work for private clients, U.S. EPA contracted with me to oversee and direct the first risk assessments for all of its Superfund sites, as did the Agency for Toxic Substances and Disease Registry to direct and write the first Toxicity Profiles. Later, I founded my own company, Sciences International, and directed it for 13 years, during which we addressed a wide variety of interesting and challenging issues. Subsequently, Exponent asked me to serve as Vice President for Health Sciences, a post I served in for 10 years, then as Chief Science Officer. More recently, I am honored to accept the Exponent designation of Senior Fellow, a rare recognition by the Company. Presently, I continue my work in the field of health risk assessment. I know that the framework and process we created in the early years made it possible to identify gaps in knowledge and point to ways for improving the foundations for health risk assessment.
- What are the emerging policy issues in the area of human health risk assessment?
Without a doubt, the need to sensibly apply the science we know to separate the important from the unimportant issues. Often, I feel that we lose sight of the fact that health risk assessment has achieved endorsement worldwide as the premier way to address the complexity of issues involved in defining public health protection. Also, the outcomes of risk assessment now have challenging new applications, e.g., in toxic tort litigation or world trade decisions.
In the policy area, one important emerging issue is the use of health risk assessment to “prove safety.” Adopting ever-diminishing levels of possible protection to achieve this goal effectively creates a “zero tolerance” policy, the very policy that would have defeated U.S. EPA at its inception. I believe that little is gained by these controversial policies that create debate for years; under these approaches we can lose sight of what is important. For example, important EPA risk assessment documents may now take years to become final because of endless debates in areas of scientific uncertainty where societal impacts can be enormous but risk reduction uncertain and marginal. We accept risk in every other part of our society, so it is unrealistic to apply a zero-risk policy to our environmental decisions.
Secondly, I feel that it is most unfortunate that the sciences so essential to public health understanding are often caught in agendas that constrain even the most objective review and use of our public health documents. There is no question that science has become politicized. I contend that U.S. EPA would have been lost without access to all scientists of importance to our decisions, regardless of who had funded their work.
Finally, I see an increasing lack of understanding of the difference between science as applied to public health protection—to preempt and prevent disease—and the science of establishing causality. It is critical to use honest science, regardless of the setting, to avoid mistakes. Distortion of scientific foundations and fact to achieve economic or political gain is deplorable and should be rejected.
- What do you enjoy most about your work in the field of human health risk assessment?
The endless challenges. Risk assessment demands that we honestly express what is known and unknown. Exploring the unknowns and narrowing our knowledge gaps are endlessly rewarding endeavors.
- What do you find to be the most challenging aspect of your work?
It is very difficult to find a single answer to this question. Exploring new science will always be at the top of the list. The greatest non-scientific challenge is the fact that not all are in engaged in finding the truth. Trying to explain the known scientific facts in situations involving exploitation of scientific unknowns or distortion, whether in the courtroom or as a part of political debate, is challenging. The climate created by the spirit of the ’60s was to seek the truth. We were all essentially on the same page; we shared common goals even as we debated the best methods of scientific approach. Today, goals often do not converge; science in the age of polarization is challenging.
- What or who helped you succeed as a leader in the area of human health risk assessment?
I have been surrounded by thought leaders and gifted people throughout my career. The environmental movement attracted so many to the new U.S. EPA. One who contributed so much to my understanding was Dr. Roy Albert, the Deputy Director of the School of Environmental Medicine at NYU. He was blessed with an extraordinary intellect and excellent sense of balance. He was the outside Chair of our Carcinogen Assessment Group in the early years, a role that would not be possible in the bureaucracy today. And I must continue to give credit to U.S. EPA Administrator Ruckelshaus.
- What advice would you give a young person today who is considering starting out in your field?
Follow your dreams. Work is never work if you feel passionate about what you are doing. Achieve the best education you can get and keep your options open. You may need to help create your own opportunity. Have confidence in your capabilities to achieve your goals and set high ones.