By Steven M. Siros, Co-Chair, Environmental and Workplace Health and Safety Law Practice
The Trump administration continues its efforts to issue new regulations in advance of January 20, 2021, with the Department of Energy (DOE) issuing a final rule that will exempt certain liquefied natural gas (LNG) projects from National Environmental Protection Act (NEPA) review. The final rule, published in the Federal Register on December 4, updates DOE’s NEPA implementing procedures with respect to authorizations issued under the Natural Gas Act in accordance with the recent revisions to the NEPA regulations as further described below.
According to DOE, the focus of the new rule is to clarify the scope of DOE’s NEPA obligations with respect to LNG projects and more specifically, to eliminate from the scope of DOE’s NEPA review potential environmental effects that the agency has no authority to prevent. Because DOE’s discretionary authority under Section 3 of the Natural Gas Act is limited to the authorization of exports of natural gas to non-free trade agreement countries, the rule limits the scope of environmental impacts that DOE must consider to the impacts associated with the marine transport of the LNG commencing at the point of export.
To that end, the final rule revises DOE’s existing Categorical Exclusions (CATEX) to reflect that the only elements of LNG projects subject to NEPA review is the following:
B5.7 Export of natural gas and associated transportation by marine vessel.
Approvals or disapprovals of new authorizations or amendments of existing authorizations to export natural gas under section 3 of the Natural Gas Act and any associated transportation of natural gas by marine vessel.
Based on prior NEPA reviews and technical reports, DOE has determined that the transport of natural gas by marine vessel normally does not pose the potential for significant environmental impacts and therefore qualifies for a CATEX. As such, the only reason that DOE would be obligated to engage in a NEPA review of a LNG project would be if “extraordinary circumstances” were deemed to be present that could not be mitigated and therefore would preclude DOE's reliance on this CATEX.
The revised CATEX also removes the reference to import authorizations from CATEX B5.7 because DOE has no discretion with respect to such approvals. Finally, the final rule also removes and reserves CATEX B5.8 and classes of actions C13, D8, D9 because these actions are outside of the scope of DOE’s authority or are covered by the revised CATEX B5.7.
Interestingly, although the Federal Energy Regulatory Commission (FERC) has responsibility for approving the construction of LNG export terminals, it has previously declined to analyze the greenhouse emissions associated with such projects, noting that DOE is the appropriate agency to consider such impacts. However, with DOE now concluding that these projects are categorically excluded from such reviews, it remains to be seen if FERC will reconsider its approach to these operations.
The final rule is scheduled to take effect on January 4, 2021 and it remains to be seen what if any action a new Biden administration might take in response to this rule. Assuming that the Republicans retain control of the Congress, DOE would be required to go through the formal withdrawal process. Alternatively, if the Democrats take control of the Senate, the regulation could be repealed pursuant to the Congressional Review Act.
We will continue to track the Trump administration’s ongoing effort to finalize regulations in advance of January 20th as well as efforts by any new administration to rollback these regulations on the Corporate Environmental Lawyer.
Environmental Groups Allege EPA Failed to Engage in Endangered Species Act Consultation Before Implementing COVID-19 Enforcement Discretion Policy
On August 18, 2020, the Center for Biological Diversity, Waterkeeper Alliance, Inc., and Riverkeeper, Inc. (“Conservation Groups”) filed a new lawsuit in the U.S. District Court for the Southern District of New York against the U.S. Environmental Protection Agency and Administrator Wheeler (“EPA”) for failing to comply with their mandatory duties under the Endangered Species Act (“ESA”) in connection with promulgation of EPA’s COVID-19 enforcement discretion policy. More specifically, the Conservation Groups argued that the EPA failed to “initiate and complete ESA Section 7 consultation to ensure that EPA’s actions in response to the COVID-19 pandemic,” as described in the March 26, 2020 “COVID-19 Implications for EPA’s Enforcement and Compliance Assurance Program” (“Temporary Enforcement Policy”), would not jeopardize any listed species or their habitats. An analysis of the Temporary Enforcement Policy can be found at Jenner & Block’s Corporate Environmental Lawyer blog here.
Other environmental groups had previously challenged EPA’s Temporary Enforcement Policy, claiming that EPA was unreasonably delaying its response to a petition filed by the groups requesting that EPA issue an emergency rule requiring written notice from regulated entities that elect to suspend required environmental reporting and/or monitoring due to the COVID-19 pandemic. On July 8, 2020, Judge McMahon of the United States District Court for the Southern District of New York ruled that the Natural Resources Defense Counsel and other environmental organizations failed to show that they were injured by EPA’s purported “unreasonable delay” and therefore granted summary judgment in favor of EPA.
In this latest lawsuit, the Conservation Groups claim that EPA failed to engage in a required ESA Section 7 consultation prior to promulgating its Temporary Enforcement Policy. Notwithstanding that EPA’s Temporary Enforcement Policy explicitly states that regulated entities should “make every effort to comply with their environmental compliance obligations” and merely provides guidance on how EPA’s plans to exercise its long-held enforcement discretion in light of the challenges posed by the COVID-19 pandemic, the Conservation Groups’ complaint explains how the regulatory programs affected by the Temporary Enforcement Policy implicate the interests of listed species and their habitat as those programs are “intended to limit pollution and prevent adverse environmental harm.” For example, the complaint asserts that suspension of Clean Water Act’s National Pollutant Discharge Elimination System (“NPDES”) effluent sampling program “potentially affects listed species and critical habitats by allowing unmonitored and unreported (and hence unrestricted) contamination of waterways such species depend on.”
The Section 7 consultation process is meant to “insure that any action authorized, funded, or carried out by such agency . . . is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of habitat of such species which is determined . . . to be critical.” 16 U.S.C. § 1536(a)(2). The Section 7 consultation process must be initiated at “the earliest possible time” for any project that “may affect” listed species. 50 C.F.R. § 402.14(a). The Conservation Groups allege that the Temporary Enforcement Policy “clearly meets the ESA’s ‘may affect’ threshold for triggering the agency’s Section 7 consultation obligations.” While the Conservation Groups recognized the unique challenges posed by COVID-19, they stated “this does not mean that EPA may simply ignore its vitally important, and legally required, ESA Section 7 duties and disregard potential impacts on imperiled species and their critical habitats.” They argue there is no evidence that the EPA undertook Section 7 consultation with the U.S. Fish and Wildlife Service or the National Marine Fisheries Service, or even followed the emergency consultation process provided for in the ESA.
EPA announced that it will terminate its reliance on the Temporary Enforcement Policy on August 31, 2020 (although EPA stated that the termination in no way limits its ability to exercise enforcement discretion on a case-by-case basis). EPA’s termination announcement was previously discussed on Jenner & Block’s Corporate Environmental Lawyer blog here. In light of EPA’s announcement, several State Attorneys Generals that had also filed a complaint challenged EPA’s Temporary Enforcement Policy indicated that they intend to dismiss their lawsuit so long as EPA terminates its reliance on the policy on or before August 31st. In an attempt to preempt what is likely to be a motion to dismiss on mootness grounds, the Conservation Groups allege that “there is no assurance that the policy will be rescinded by that date, particularly given the recent surge in COVID-19 cases,” and that their case should therefore be allowed to proceed.
Please feel free to contact the authors with questions or for further information. For regular updates about the impact of COVID‑19 in the workplace and on business generally, please visit Jenner & Block’s Corporate Environmental Lawyer blog and Jenner & Block’s COVID‑19 Resource Center.
On July 30, 2020, New York’s Public Health and Planning Council voted to establish maximum contaminant levels (MCLs) for PFOA and PFOS, two of the more common per- and polyfluoroalkyl substances known as PFAS. The MCL for both PFOA and PFOS was set at 10 parts per trillion (ppt) and once approved by the state’s Health Commissioner, public water systems serving 10,000 people or more will be required to start testing for these compounds within 60 days of the date the regulations are published in the New York State Register. Systems serving between 3,300 and 9,999 person would have to begin testing within 90 days, while all other systems would need to begin testing within six months. In conjunction with setting the PFAS MCL, New York also set a 1 part per billion MCL for 1,4-dioxane, another emerging contaminant.
The most immediate impact of the new MCLs will be the testing obligation it imposes on drinking water providers. If these contaminants are detected in drinking water above the MCL, the drinking water provider will be required to notify its consumers and develop a plan to address the MCL exceedances. Although New York has historically provided grants to assist municipalities in addressing these types of emerging contaminants, these grants are unlikely to be sufficient in light of the wide-spread testing that will now be required. As such, one can likely expect a substantial increase in litigation as municipalities aggressively look to shift the burden of paying for these remedial measures from ratepayers to manufacturing and/or other industrial operations that may have contributed to the presence of these contaminants in the environment.
Under Section 401 of the Clean Water Act (“CWA”), projects requiring federal permits or licenses that have the potential to result in point source discharge into waters of the United States must obtain a Section 401 water quality certification evidencing compliance with applicable state water quality standards. Until this state certification is received, a project can’t obtain its federal permit or license.
In response to claims that the states are unreasonably delaying Section 401 certifications and/or imposing requirements that go beyond the mandates of the CWA, U.S. EPA has issued a final rule clarifying the time period for states these certification reviews and limiting the conditions that can be imposed on a project as part of this certification process. In a press release accompanying the final rule, U.S. EPA Administrator Andrew Wheeler stated that “EPA is returning the Clean Water Act certification process under Section 401 from its original purpose, which is to review potential impacts from discharges from federally permitted projects may have on water resources, not to indefinitely delay or block critically important infrastructure.”
Section 401 of the CWA requires certifying authorities to act on Section 401 certification requests within a “reasonable period of time” that shall not exceed one year. 33 U.S.C. 1341(a)(1). Federal licensing and permitting agencies are tasked in the final rule with establishing what constitutes a “reasonable period of time either categorically or on a case-by-case basis” but in no circumstances can the period exceed one year. 40 CFR § 121.6. The final rule provides that the “reasonable period of time” starts to run once the certifying agency receives a “certification request” as opposed to running once the certifying authority deems the application or request “complete” as had been the historical practice.
The final rule also clarifies that the state review is limited to ensuring compliance with water quality standards as opposed to addressing non-water quality related considerations For example, U.S. EPA noted that certifying authorities have “on occasion required in a certification condition the construction of biking and hiking trails … and the creation of public access for fishing along waters of the United States.” Certifying authorities have also attempted to address air emission and transportation effects as part of the certification process. U.S. EPA's final rule specifically states that the Section 401 certification “is limited to assuring that a discharge from a Federally licensed or permitted activity will comply with water quality requirements.” 40 CFR § 121.3.
Within this “reasonable time period” set by the permitting agency, certifying authorities can grant, grant with conditions or deny certification requests. 40 CFR § 121.7. Certifying authorities may also waive the certification requirement, either expressly or by failing to act. 40 CFR § 121.9. Section 401 certifications must include supporting information for each condition, including a statement explaining why the condition is necessary to assure that the discharge will comply with state water quality requirements. Denials must state the reasons for denial, including the specific water quality requirements with which the discharge will not comply, and if the denial is for insufficient information, the denial must describe the specific information that would be required. In the event that a certifying authority fails to comply with the procedural requirements governing the certification process, the final rule allows the permitting agency to deem that the certifying agency has waived its certification rights. 40 CFR § 121.9(a)(2).
U.S. EPA's final rule has been praised by industry groups with the American Petroleum Institute issuing a statement that " the addition of a well-defined timeline and review process will provide certainty to operators as they develop infrastructure projects that meet state water quality standards." The Natural Resources Defense Council, on the other hand, issued a statement claiming that the new rule "makes a mockery of this EPA's claimed respect for cooperative federalism."
Please feel to contact the author with questions or for further information. For regular updates on breaking environmental, health and safety issues, please visit Jenner & Block’s Corporate Environmental Lawyer Blog.
By Leah M. Song
On May 26, 2020, the Ninth Circuit agreed with plaintiffs that two climate change lawsuits—County of San Mateo v. Chevron Corp. et al. and City of Oakland v. BP p.l.c. et al.—had been improperly removed to the federal courts, continuing courts’ recent trend of remanding these types of cases back to state court.
A growing form of climate change litigation in the United States consists of lawsuits filed by states or municipalities against private industry, and more specifically, the fossil-fuel industry. States, cities and other units of local government have filed lawsuits alleging state common law theories, including nuisance, trespass, failure to warn of the known impacts of climate change, and unjust enrichment. The outcome of these cases thus far has hinged on whether or not the fossil fuel companies are able to successfully remove the litigation to federal court where they stand a much greater chance of getting the litigation dismissed. Generally, plaintiffs (including states, units of local government, and non-governmental organizations) asserting climate change claims against corporations prefer to be in state court where they can take advantage of perceived plaintiff-friendly common law or state statutes. On the other hand, defendants inevitably seek to remove such cases to federal court where they have had a higher level of success securing dismissals on the grounds that the issue is preempted by the Clean Air Act and/or addresses a “political question” which is better left to the discretion of Congress. See City of N.Y. v. BP P.L.C.. 325 F. Supp. 3d 466 (S.D.N.Y. 2018).
In County of San Mateo v. Chevron Corp. et al., six California municipalities and counties sued more than 30 fossil-fuel companies in California state court. The plaintiffs brought a variety of claims under state common law including nuisance, negligence, failure to warn, and trespass. In City of Oakland v. BP p.l.c. et al., the Cities of Oakland and San Francisco sued five fossil-fuel companies in state court under a theory of nuisance. The fossil-fuel companies removed both cases to federal court. The San Mateo district court remanded the case back to state court while the Oakland district court refused to remand the case back to state court, finding that plaintiffs’ public nuisance claims were governed by federal common law, but then proceeding to dismiss the lawsuit. Both cases were appealed to the Ninth Circuit.
On May 26th, the Ninth Circuit joined the Fourth Circuit (Mayor and City Council of Baltimore v. BP P.L.C., et al., No. 19-1644 (4th Cir. Mar. 6, 2020)) in concluding that these climate change cases alleging only state-common law claim belonged in state court. In County of San Mateo v. Chevron Corp. et al., the Ninth Circuit emphasized its limited authority to review an order remanding a case back to state court under 28 U.S.C. § 1447(d). The Ninth Circuit therefore limited its review to determining whether the district court erred in holding that the federal court lacked subject matter jurisdiction under the federal-officer removal statute.
In order to determine whether the district court erred in holding that it did not have subject matter jurisdiction, the Ninth Circuit examined whether the companies were “acting under” a federal officer’s directions. The companies argued that they were “persons acting under” a federal officer based on several agreements with the government. However, the Ninth Circuit concluded that the companies’ activities under these agreements did not give rise to a relationship where they were “acting under” a federal officer. Accordingly, the Ninth Circuit court held that the fossil fuel companies failed to meet their burden for federal-officer removal and therefore affirmed the district court’s remand order.
In City of Oakland v. BP p.l.c. et al., the Ninth Circuit considered whether “the district court erred in determining that it had federal-question jurisdiction under 28 U.S.C. § 1331” and ultimately held that plaintiffs’ state common-law public nuisance claims did not arise under federal common law. The court acknowledged that there are exceptions to the well-pleaded complaint rule for claims that arise under federal law, but concluded that none of those exceptions applied here.
The court reasoned that “[t]he question whether the Energy Companies can be held liable for public nuisance based on production and promotion of the use of fossil fuels and be required to spend billions of dollars on abatement is no doubt an important policy question, but it does not raise a substantial question of federal law for the purpose of determining whether there is jurisdiction under § 1331.” Furthermore, evaluation of the public nuisance claim would require factual determinations which are “not the type of claim for which federal-question lies.” The fossil fuel companies argued that the plaintiffs’ public nuisance claim was completely preempted by the Clean Air Act, but the court was not persuaded.
In response to defendants’ argument that by amending their complaint to assert a federal common law claim, the district court properly had subject matter jurisdiction under 28 U.S.C. § 1331, the Ninth Circuit noted that plaintiffs only amended their complaint in response to the district court’s statements that plaintiffs’ claims were governed by federal common law. Moreover, the Ninth Circuit noted that since a party violates § 1441(a) “if it removes a cases that is not fit for federal adjudication, a district court must remand the case to state court, even if subsequent action conferred subject-matter jurisdiction on the district court.”
Notwithstanding these conclusions, the Ninth Circuit noted that the district court had not addressed alternative bases for removal raised by defendants and therefore remanded the case back to the district court. However, the Ninth Circuit specifically noted that if the district court concludes that there are no valid bases for federal jurisdiction, the case should be remanded back to state court.
Although these rulings did not address the merits of plaintiffs’ common-law claims, these cases will certainly pose challenges for defendants seeking to remove these types of cases to federal court, and will likely affect plaintiffs’ and defendants’ strategies in climate change litigation moving forward. Jenner & Block’s Corporate Environmental Lawyer will continue to update on those matters, as well as other important climate change litigation cases, as they unfold.
U.S. EPA Extends Comment Period on PFAS Safe Drinking Water Act Regulatory Determination to June 10, 2020
As discussed in more detail in a previous blog, on February 20, 2020, the U.S. Environmental Protection Agency (“U.S. EPA”) announced that it was seeking public comments on its preliminary regulatory determination that seeks to implement regulatory limits for Per- and Polyfluoroalkyl Substances (PFAS) in public drinking water across the United States. The regulatory determination is a key step in the creation of a Maximum Contamination Level (“MCL”) that will act to limit the quantity of PFAS permitted in public drinking water.
In its preliminary regulatory determination, U.S. EPA proposes setting MCL levels for two PFAS substances, perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), which EPA has determined meet the statutory criteria to become regulated contaminants under the Safe Drinking Water Act. To meet this criteria, U.S. EPA had to find that: (1) the consumption of PFOS and PFOA may result in adverse health effects; (2) PFOS and PFOA have been identified in public water supplies at frequencies and levels sufficient to cause a public health concern; and (3) that new regulation presents a meaningful opportunity to reduce the health risks posed by PFOS and PFOA.
The Association of Metropolitan Water Agencies and the American Water Works Association (collectively “AMWA”) submitted comments that were supportive of setting an MCL for PFOS and PFOA. In addition to targeting PFOA and PFOS, the AMWA recommended that U. S. EPA also include four other long-chain PFAS compounds in its regulatory determination. AMWA also recommended that U.S. EPA “thoroughly consider state standards and guidelines with significantly lower PFAS levels that [U.S. EPA’s] Health Advisory Level (HAL) of 70 parts per trillion (ppt) for combined concentrations of PFOA and PFOS.”
The AMWA also requested that U.S. EPA extend the comment period an additional 30 days to allow the AMWA to more fully engage with its members and to provide more meaningful and comprehensive comments on the proposal. To that end, U.S. EPA has now agreed to extend the comment period an additional 30 days May 10th to June 10th.
On April 23, 2020, the U.S. Supreme Court issued an important decision on the reach of the Clean Water Act (“CWA”). The Court’s decision in County of Maui, Hawaii v. Hawaii Wildlife Fund, Case No. 18–260, addresses whether the CWA requires a permit when pollutants originate from a point source but are conveyed to navigable waters by a nonpoint source such as groundwater. In a 6-3 opinion, the Court held that CWA permitting authority extended to indirect discharges that are the functional equivalent of a direct discharge from a point source into navigable waters. Justice Breyer delivered the opinion of the Court, joined by Justices Roberts, Ginsburg, Sotomayor, Kagan and Kavanaugh. Justice Kavanaugh also wrote a concurring opinion and Justices Thomas, Gorsuch and Alito dissented.
At issue in the case was the County of Maui’s wastewater reclamation facility located on the island of Maui, Hawaii. The County pumps partially treated sewage through four injection wells hundreds of feet underground. After injection, the effluent travels approximately a half mile through groundwater to the Pacific Ocean.
The case came up from the Ninth Circuit, which had ruled that a permit was required when “the pollutants are fairly traceable from the point source to a navigable water such that the discharge is the functional equivalent of a discharge into the navigable water.” Hawaii Wildlife Fund v. County of Maui, 886 F. 3d 737, 749 (9th Cir. 2018) (emphasis added). The Supreme Court took issue with the Ninth Circuit’s fairly traceable standard, explaining that “[v]irtually all water, polluted or not, eventually makes its way to navigable water” and thus, the lower court’s standard would give EPA broad new permitting authority not supported by the CWA’s statutory language or legislative history. Slip Op. at 5.
Supreme Court issues Landmark CERCLA Ruling Finding that State Law Challenges to USEPA Cleanup Can Be Raised in State Court (But Plaintiffs Still Lose)
On Monday, April 20, 2020, the United States Supreme Court issued a key opinion regarding the preclusive effect of the Comprehensive Environmental Response, Compensation and Recovery Act (CERCLA), 42 U.S.C. Section 9601, on state common law remedies within Superfund Sites. In Atlantic Richfield v. Christian, Case No. 17-1498, the Supreme Court affirmed in part and vacated in part a decision by the Montana Supreme Court that “restoration claims” asserted by private property owners could go forward against a potentially responsible party (PRP) that had previously settled its CERCLA liability with the United States Environmental Protection Agency (USEPA).
The case involves the Anaconda Smelter Site, a Superfund site covering 300 square miles of property contaminated by historical smelter and ore processing operations. In 1983, USEPA identified Atlantic Richfield Co. as a PRP for the site’s contamination and the parties entered into a settlement agreement that required Atlantic Richfield to investigate and remediate the site under the oversight of USEPA. In the 37 years since, USEPA has managed an extensive cleanup at the site, which included the removal of 10 million cubic yards of contaminated soil and capping in place an additional 500 million cubic yards of waste over 5,000 acres. Atlantic Richfield estimates that it has spent approximately $450 Million USD remediating the site and that its cleanup is nearly complete.
However, the USEPA-mandated cleanup standards were deemed insufficient by a number of local landowners who allege that their properties remain damaged by Atlantic Richfield’s contamination. The landowners asserted common law tort claims against Atlantic Richfield seeking funds to remediate their properties—located within the Superfund Site—beyond the levels required by the USEPA-approved remedy. For example, the plaintiffs sought funding to remediate arsenic levels in their properties’ soil to a level of 15 parts per million, rather than the 250 parts per million limit approved by USEPA. In total, the additional cleanup efforts sought by plaintiffs are estimated to cost Atlantic Richfield an additional $50 to $58 million in cleanup costs. Following the Montana Supreme Court’s holding that the landowner’s restitution claims could proceed in spite of Atlantic Richfield’s settlement with USEPA and the ongoing cleanup effort, Atlantic Richfield appealed the issue to the Supreme Court.
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.
On January 16, 2020, U.S. EPA added 160 per- and polyfluoroalkyl substances (PFAS) to the Toxics Release Inventory (TRI). The addition of these 160 PFAS compounds to the TRI inventory means that as of January 1, 2020, companies will need to track releases of these compounds, and releases exceeding the threshold, which was set at 100 pounds, must be reported to U.S. EPA. Interestingly, there currently is an open Advance Notice of Proposed Rulemaking (ANPR) that seeks public comment on whether and how to include PFAS on the TRI inventory, but U.S. EPA noted that the 2020 National Defense Authorization Act (NDAA) required it to add these 160 substances to the inventory. Although the NDAA only specified 14 PFAS that needed to be added to the inventory, it did specify that PFAS that were the subject of a significant new use rule on or before December 20, 2019 under the Toxic Substances Control Act also needed to be added to the TRI inventory.
U.S. EPA’s actions have already triggered a number of questions. For example, how is the ANPR (which remains open through February 3, 2020) affected by U.S. EPA’s decision to add these chemicals to the inventory? How does one accurately measure PFAS air emissions since the methodology for measuring these emissions is currently being developed? Hopefully, further clarification on these issues will be forthcoming in the near future.
On January 17, 2020, the State of California filed a new complaint against the United States Bureau of Land Management (“BLM”) seeking to block a BLM-issued resource management plan that proposes to open up more than one million acres of California land to hydraulic fracking and other forms of oil and gas drilling. If enacted, the challenged BLM plan would end a five-year moratorium on leasing land in California to oil and gas development.
The federal lawsuit announced by California Attorney General Xavier Becerra asserts that the BLM’s review of environmental impacts associated with its resource management plan violates the National Environmental Policy Act (“NEPA”) and Administrative Procedure Act (“APA”). Specifically, the lawsuit alleges that the BLM failed to sufficiently consider impacts to people who might live near newly drilled oil and gas wells and that the BLM underestimated the environmental impacts of new fracking wells that would become active as a result of the plan. In a news conference announcing the lawsuit, Becerra stated that “much of the federal oil and gas activity in the state happens near some of our most vulnerable communities, communities [that] are already disproportionately exposed to pollution and its health effects.” Finally, California’ lawsuit asserts that BLM failed “to consider conflicts with state plans and policies, including efforts by California to reduce greenhouse gas emissions and fossil fuel consumption to mitigate the devastating consequences of global climate change.”
The legal challenge is not the first made against the BLM’s resource management plan. In 2012, BLM issued a final environmental review supporting its decision to open up approximately one million acres of federal land in California for mineral leasing. At the time, BLM estimated that approximately 25% of the new wells on this land would be used for hydraulic fracturing. However, in 2016, the California courts set aside the plan finding that the BLM’s environmental review had failed to comply with the full requirements of NEPA. On May 3, 2017, BLM entered into a settlement agreement that required the agency to prepare additional NEPA documentation and issue a new decision amending or superseding its resource management plan, as appropriate. The updated plan is the subject of the most recent lawsuit filed by the State of California. In the current lawsuit, California now asserts that approximately 90% of new wells on the federal land will be utilized for hydraulic fracturing.
The recent lawsuit is only one of more than 65 lawsuits filed by the State of California against the Trump Administration. California’s lawsuits include more than 25 challenges to policies and actions proposed by the United States Environmental Protection Agency and other federal agencies responsible for setting environmental and energy policies.
The fact that neither perfluorooctanoic acid (PFOA) nor perfluorooctane sulfonic acid (PFOS) is classified as a hazardous substance may prove fatal to plaintiffs’ efforts to convince a federal court to allow a novel citizen suit to proceed. In the case of Kristen Giovanni, et al. v. Navy which is pending in the U.S. District Court for the Eastern District of Pennsylvania, plaintiffs brought a citizen suit under a Pennsylvania cleanup statute seeking to compel the Navy to monitor residents for potential health issues linked to PFOS and PFOA exposure. In October 2018, the Third Circuit Appellate Court affirmed an earlier ruling from the district court that had rejected plaintiffs’ efforts to compel the Navy to undertake a government-led health assessment, finding that such a request constituted an impermissible challenge to an ongoing CERCLA response action. The Third Circuit concluded that plaintiffs' request for a government-led health study sought injunctive relief that could potentially interfere with the ongoing response action at the site. Plaintiffs’ request for medical monitoring, on the other hand, sought to compel the Navy to fund a trust, which the Third Circuit concluded was not a challenge to ongoing response actions at the site.
During a hearing following remand from the Third Circuit, the district court judge noted that Section 1115 of Pennsylvania’s Hazardous Sites Cleanup Act (HSCA) (which provides for a citizen-suit right of action) only provides relief for HSCA designated “hazardous substances.” Although plaintiffs’ counsel argued that PFOA and PFOS fell within the HSCA’s definition of “hazardous substances,” in fact neither substance has been designated as a “hazardous substance” under CERCLA, nor have they been so designated by the Pennsylvania Department of Environmental Protection. In what may be foreshadowing of how the court intends to rule, the judge noted that if he were to dismiss plaintiffs’ case, in the event that either the state or U.S. EPA were to designate PFOA and/or PFOS as “hazardous substances,” plaintiffs would be able to file a new lawsuit.
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:
PFAS Regulations Projected to Impose Billions of Dollars of Compliance Costs on Drinking Water Systems
A recent report from the Congressional Budget Office (CBO) estimated that the costs to comply with anticipated drinking water standards for per- and polyfluoroalkyl substances (PFAS) are likely to exceed “several billion dollars.” The CBO analyzed Senate Bill 1507 which passed out of Senate Environment & Public Works Committee earlier this year. Senate Bill 1507 seeks to require U.S. EPA to promulgate drinking water standards for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) and imposes monitoring requirements on drinking water systems. The bill could potentially impose fairly stringent requirements on more than 67,000 public water systems.
The CBO estimate comes on the heels of a recent New Hampshire court decision that put on hold New Hampshire’s newly promulgated groundwater standards setting a 12 part per trillion (ppt) limit on PFOA and 15 ppt limit on PFOS. The standards were challenged on the basis that New Hampshire’s Department of Environmental Services (DES) had not conducted an adequate cost-benefit analysis of the new regulatory standards. The court agreed that DES had not conducted the cost-benefit analysis required by New Hampshire statutes and therefore enjoined DES from enforcing the new groundwater standards until such time as the analysis is completed.
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.
On October 15th, the Department of Defense (DoD) issued an internal guidance document regarding CERCLA cleanup actions involving per- and polyfluoroalkyl substances (PFAS). The DoD guidance sets screening levels for three PFAS compounds that some have criticized as being inconsistent with draft screening levels that are in the process of being finalized by U.S. EPA.
DoD’s October 15th guidance document adopts U.S. EPA’s proposed screening level (in groundwater) of 40 parts per trillion (ppt) for sites containing both perfluorooctane sulfonate (PFOS) and perfluorooctanioic acid (PFOA). However, the DoD guidance adopts a higher screening level for sites containing only one of the three targeted PFAS compounds. For sites containing only PFOA or PFOS, the DoD screening level jumps to 400 ppt. The guidance also sets a screening level for perfluorobutanesulfonic acid (PFBS) (a shorter chain PFAS compound) at 40,000 ppt.
The DoD guidance is silent with respect to other PFAS compounds. The guidance also doesn’t specify a particular clean-up level if the above-referenced screening levels are exceeded. Instead, the guidance notes that a site-specific risk assessment will be conducted to determine if remedial measures are necessary.
Notwithstanding the DoD guidance document, there is no indication that U.S. EPA will not continue to rely on its 40 ppt level screening (both for single- and combined-PFAS compound sites) and 70 ppt preliminary cleanup goal proposed in its draft interim guidelines for remediating PFAS-impacted groundwater at DoD sites.
Jenner and Block and ELI cordially invite you to attend a seminar titled “Managing the Great Lakes” on October 29, 2019 from 2:00 pm to 5:00 pm (CST) at Jenner and Block’s office (353 N. Clark Street) in Chicago and by webinar.
There will be two panel presentations. The first presentation focuses on the Great Lakes Compact and water rights in the Great Lakes Basin. Panel participants include Cameron Davis (former Great Lakes Czar) and Victoria Pebbles (Program Director for the Great Lakes Commission). The second presentation focuses on managing algae blooms in the Great Lakes. Panel participants include Todd Nettesheim (Deputy Director of EPA’s Great Lakes National Program) and Todd Brennan (Senior Policy Manager for Alliance for the Great Lakes).
A reception sponsored by Exponent and Brown and Caldwell immediately follows the seminar.
Please click here for more information and to register.
On October 10, 2019, EPA announced a proposed rule that would significantly revise how public water systems evaluate and address lead in drinking water. This is the largest change to the Lead and Copper Rule since the rule was promulgated in 1991. Under the authority of the Safe Drinking Water Act, the purpose of the Lead and Copper Rule is to protect public health by minimizing lead and copper levels in drinking water, mainly by reducing water corrosivity because lead and copper enter drinking water primarily from corrosion of lead and copper in plumbing materials.
The original Lead and Copper Rule established a Maximum Contaminant Level Goal (“MCLG”) of zero lead in drinking water, and an Action Level of 15 parts per billion (“ppb”). The proposed Lead and Copper Rule Revision maintains the current MCLG and Action Level, but will require a more comprehensive response at the Action Level and introduces a lead Trigger Level of 10 ppb that requires more proactive planning in communities with lead service lines.
The proposed Lead and Copper Rule Revision focuses on six key areas of improvement:
- Identifying the most impacted areas by requiring water systems to prepare and update a publicly-available inventory of lead service lines and requiring water systems to “find-and-fix” sources of lead when a sample in a home exceeds 15 ppb.
- Strengthening drinking water treatment by requiring corrosion control treatment based on tap sampling results and establishing a new trigger level of 10 ppb.
- Replacing lead service lines by requiring water systems to replace the water system-owned portion of a lead service line when a customer chooses to replace their portion of the line. Additionally, depending on their level above the trigger level, systems would be required take lead service line replacement actions.
- Increasing drinking water sampling reliability by requiring water systems to follow new, improved sampling procedures and adjust sampling sites to better target locations with higher lead levels.
- Improving risk communication to customers by requiring water systems to notify customers within 24 hours if a sample collected in their home is above 15 ppb. Water systems will also be required to conduct regular outreach to the homeowners with lead service lines.
- Better protecting children in schools and child care facilities by requiring water systems to take drinking water samples from the schools and child care facilities served by the system.
In an EPA press release, Administrator Andrew Wheeler touted the advancements in the proposed rule:
By improving protocols for identifying lead, expanding sampling, and strengthening treatment requirements, our proposal would ensure that more water systems proactively take actions to prevent lead exposure, especially in schools, child care facilities, and the most at-risk communities. We are also working with the Department of Housing and Urban Development to encourage states and cities to make full use of the many funding and financing options provided by the federal government.
The proposed Lead and Copper Rule Revision was released by EPA as a pre-publication version. Once the proposed rule is published in the federal register, public comments will be accepted for 60 days at www.regulations.gov. More information is available at EPA’s website.
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.
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.