U.S. EPA Adds 160 PFAS Substances to TRI Reporting List
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.
California Files Lawsuit Aimed at Halting Trump Administration Fracking Plans
By Matthew G. Lawson
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.
Failure to Designate PFAS as Hazardous Substance May Doom Medical Monitoring Lawsuit
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
By Matthew G. Lawson
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:
requiring that all EISs be completed within a two-year time limit;
limiting the scope of projects that trigger the requirement to draft an EIS; and
in the case of private actions that require federal approval, allowing private companies to take lead in reviewing potential environmental impacts under the supervision of a federal agency.
Perhaps most critically, CEQ is expected to advise that federal agencies are no longer required to consider “cumulative” environmental consequences when accounting for the environmental impacts of a specific action. This language appears aimed at eliminating the requirement that federal agencies consider the impact of increased greenhouse gas (“GHG”) emissions and climate change as part of their NEPA review. The proposal comes after several high profile infrastructure projects back by President Trump, including the Keystone XL oil pipeline, were blocked by federal judges on the basis that the project’s EIS failed to sufficiently consider the impacts of climate change.
While the CEQ regulations have not been comprehensively revised since 1986, in recent years the Obama and Trump Administrations have independently sought to clarify the obligation imposed on Federal agencies to consider GHG emissions and climate change under NEPA. In 2016, the Obama Administration CEQ released guidance endorsing the view that NEPA requires federal agencies to consider and quantify any reasonably foreseeable GHG emissions that are attributable to a proposed action. However, this guidance was subsequently withdrawn by the Trump Administration CEQ in 2017, and replaced in June 2019 with draft guidance that cautioned agencies to only consider GHG emissions that were “substantial enough to warrant quantification” and not “overly speculative.”
Once the CEQ’s newly proposed regulations are released and filed in the federal register, the public will be afforded 60 days to comment on the changes. From this point, the Trump Administration is aiming to publish the final regulations before the presidential election in November. However, before the new regulations can take effect, environmental groups are expected to challenge them in court proceedings.
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.
U.S. EPA May Require Companies to Report PFAS Releases in TRI Reports
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.
Environmental Groups Collaborate on Launch of National PFAS Clearinghouse
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.
DoD Quietly Releases PFAS Screening Levels
By Steven M. Siros
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.
Managing the Great Lakes Seminar—October 29th
By Steven M. Siros
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.
EPA Proposes Overhaul of Lead and Copper Drinking Water Rule
By Allison A. Torrence
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.
The trend started with a June 8, 2017 policy directive issued by then Attorney General Jeff Sessions which broadly prohibited settlement agreements from “directing or providing” payment to any third-parties that are neither victims nor parties to the lawsuits. The directive had the immediate effect of prohibiting SEPs that require violators to fund environmental project performed by third parties.
The 2017 directive was then followed by a second memorandum on November 11, 2018, which barred the use of consent decrees to achieve “general policy goals or to extract greater or different relief from the defendant than could be obtained through agency enforcement authority or by litigating the matter to judgment.”
Finally, in its most recent move, the August 21st DOJ memorandum issued from the Department’s Environmental and Natural Resource Division details the DOJ’s determination that environmental SEPs are prohibited under the November 2018 directive. Specifically, the memo provides that “[t]he use of SEPs in consent decrees with state and local governments contravenes the prohibition on using consent decrees to ‘extract greater or different relief from [a state or local government] than could be obtained through agency enforcement authority or by litigating the matter to judgment.’” While the memorandum notes several conditions where SEPs may still be permitted, it cautions that exemptions to the general prohibition “are meant to be rare.”
With the DOJ’s most recent actions, it appears that environmental regulators will no longer be permitted to agree to SEPs in most, if not all, settlement agreements. However, open questions remains whether regulators will be able to fashion future SEPs that comply with the recent DOJ directives.
How Low Will The Regulators Go: California Sets New PFOA/PFOS Drinking Water Notification Guidelines
By Steven M. Siros
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.
Dr. Anderson was interviewed by Gabrielle Sigel, Co-Chair, Environmental and Workplace Health and Safety Law Practice, Jenner & Block
Exploring the E-Suite with Dr. Shalini Vajjhala, Founder and CEO, re:focus partners (San Diego, CA), and former Deputy Assistant Administrator in the Office of International & Tribal Affairs at the US EPA.
Exploring the E-Suite with Dr. Shalini Vajjhala, Founder and CEO, re:focus partners (San Diego, CA), and former Deputy Assistant Administrator in the Office of International & Tribal Affairs at the US EPA.
Exploring the E-Suite with Joel Brammeier, President and CEO, Alliance for the Great Lakes
- Tell us about re:focus partners, including what the organization does and your role.
re:focus is a design firm that specializes in developing resilient infrastructure solutions for cities and communities around the world and integrating project finance into the design process. Our team brings together expertise in policy, engineering, and risk management to craft integrated projects and develop new public-private partnerships. The goal of every re:focus project is to better align public funds and leverage greater private investment to protect and improve the lives of vulnerable communities.
As Founder and CEO, my role involves setting the strategic direction of the organization and putting together our major initiatives and partnerships. Like most small organizations, everyone on our team does a little bit of everything, and on the day-to-day level, I usually have my sleeves rolled up on various project management, design, and analysis tasks and pieces of writing.
- What is your professional background that led you to become involved in the energy and environmental fields?
I am an architect first and foremost, and I have always loved the field of green design. I went on to do graduate work in engineering and public policy (also at Carnegie Mellon University), which widened my view of the many ways to engage in the energy and environmental fields. My research focused on how community mapping could inform environmental decision-making. When I finished my PhD in 2005, I went on to join Resources for the Future, an economics think-tank in Washington, DC, as one of a handful of non-economists in the organization. Being more of a “methods” rather than domain-specific researcher gave me tremendous freedom to work on issues from infrastructure siting to environmental justice and climate change adaptation, which all have important spatial dimensions and community engagement at their core.
In early 2009, I joined the Obama Administration and spent a few months at the White House Council on Environmental Quality before moving to the US EPA’s Office of International and Tribal Affairs. In my time in the Administration, I worked on a huge range of issues, but one of the common threads was pulling together interesting public-private partnerships to make progress where public-sector resources alone were insufficient.
I stepped down from my position at the EPA in 2012, just before Hurricane Sandy hit the eastern seaboard, and was urged by our various partners to continue the green infrastructure and resilience work I had started at EPA. That’s how re:focus came to be. In hindsight, I feel tremendously fortunate to have had the chance to focus on interesting problems and follow those problems into new career opportunities that allowed me to tackle the same challenges from very different vantage points, from research to policy-making to entrepreneurship.
- What do you think are the emerging issues in the energy and environmental fields, especially your work in sustainable infrastructure?
We all recognize when infrastructure fails, but we rarely invest in new systems to prevent disaster and protect communities. I think the biggest emerging issue in the energy and environmental field is how we create robust and resilient infrastructure systems of all kinds and recognize the value of the “avoided losses” or the successes where something doesn’t happen—a storm hits, but a community isn’t devastated. Just as with preventative healthcare, valuing and capturing the value of these kinds of investments is going to be essential if we are going to successfully transition to more resilient communities and economies over the coming decade.
- What aspects of working in the energy and environmental fields have you enjoyed most?
My favorite part of working in a field that is so broad is learning from the experiences and perspectives of colleagues from very different backgrounds and disciplines, and finding new lenses through which to see old and stubborn problems.
- What do you find are some of the most challenging aspects of your work in the energy and environmental fields?
Change is hard. Change in the public sector is even harder. One of the best strategies I have found to making real and persistent change is to gradually create space for something new by starting where an existing system is failing. It is much easier to talk someone from a sinking ship onto a lifeboat than it is to get someone to shift course if they don’t know their boat is taking on water. Too often we cling to a system that we know isn’t working for us today to avoid the unfamiliar tomorrow. Finding gentle ways to bring up existing problems and look for better solutions is the most reliable approach I have found to make something new seem like the preferred alternative to the status quo.
One important thing I try to avoid is making a future problem or benefit more important than what is happening now. Lots of experts from behavioral economics to psychology know that people everywhere struggle to make decisions that have benefits in the distant future. Instead, we look for where stakeholders in a system are losing money or value today—for example, talking about the costs of current local flooding instead of only talking about future climate changes—since these same systems are likely to be the first to fail or worst off in future.
- How did you make the transition from several high-profile energy and environmental policy positions in Washington, DC to becoming a sustainable-infrastructure startup founder?
I launched re:focus in 2012 after spending several years in multiple positions at CEQ and EPA. My roles at EPA gave me the opportunity to work with many incredibly dedicated civil servants across the federal government. One of the initiatives that I created and that our team at the Office of International and Tribal Affairs was instrumental in developing was the US-Brazil Joint Initiative on Urban Sustainability (JIUS). The program was an experiment to see how government agencies could build new public-private partnerships to leverage funding for green infrastructure. Based on its early success in bringing together non-traditional partners, it quickly grew into a binational presidential initiative, announced by President Obama and Brazilian President Dilma Rousseff, to catalyze investment in sustainability in cities around the world. This collaboration brought together federal, state and local government officials with a whole bunch of unconventional private sector companies to find new ways to develop and finance green infrastructure in the cities of Rio de Janeiro, Brazil and Philadelphia, PA. Despite their many differences, these two cities still face many similar challenges when it comes to designing and financing new water, energy, and transportation systems. We turned the role of government on its head and found new ways for government agencies to tackle age-old problems. For example, in Rio, we explored how the local civil defense authorities could help fund water infrastructure in slums to reduce landslide risks and save money in their own disaster response budget.
Thanks to the leadership of both of these cities, the lessons from the JIUS (pronounced: juice) were successfully highlighted at the UN Conference on Sustainable Development or Rio+20 in June 2012. Through the JIUS, it became clear that we were playing a unique role in designing and brokering new types of public-private partnerships for sustainable infrastructure, and re:focus was born to continue this unusual work.
Because I got nudged (by our many philanthropic, NGO, and corporate partners) into starting a social business to continue work that I was already doing, the transition to entrepreneurship was a bit more natural than it might have been otherwise.
- As a former policymaker turned startup founder that operates in the sustainable infrastructure space, what can today’s policymakers learn from your challenges and successes?
I love this question. It’s something we think (and write!) a lot about, and most of our team has worked inside government at some point. We work hard to remember the constraints we faced and the things that were barriers for us when we were in their shoes. We also make an effort to share where and when we get stuck so our government collaborators can see things from “the other side.” As one example, over the past two years we’ve dedicated a significant amount of time to tackling procurement barriers to help both local governments and innovative companies struggling to find new solutions for their highest-priority challenges.
The most important lessons we’ve learned are that designing major infrastructure projects takes time and investing in predevelopment (all the things you need to do before construction) is essential, so you don’t just build another version of what you had, but you genuinely get to a solution that will serve your community well into the future.
- What and/or who have helped you succeed as a startup founder?
I have to credit my colleagues for every success we’ve had at re:focus. We are a tiny but mighty team, and working with good people who can laugh and persevere together through the daily ups and downs of any start-up is what makes the work worth doing. A couple of years ago, we realized that one of our major initiatives was worth spinning out into a sister company. My colleagues Elle Hempen and Ellory Monks launched The Atlas Marketplace and did an amazing job turning a spreadsheet into a social business to help cities find, source, and procure innovative solutions for everything from stormwater management to urban mobility systems. Having other female founders to celebrate the wins with and empathize when things are bumpy is one of my greatest sources of support.
- What advice would you give a young person today who is considering starting out in the energy and environmental fields?
Follow interesting problems. Careers are no longer linear progressions within a single firm. Many of the biggest opportunities in energy, environment and sustainability are at the “seams” of existing sectors and fields. At re:focus we work hard to serve as ambassadors between traditional silos. Often our work involves finding other connectors and helping everyone see a problem in the same way. For example, in talking with both transportation and water experts about greening urban stormwater systems, we try to find simple illustrations—like turning the city from a funnel into a sponge—so we avoid jargon and create the space for collaborative problem solving. Often our most successful work will involve someone saying, “Well, we've never done this before, but it looks like a little bit of x and y with a dash of z thrown in.” No one can be an expert in everything but even someone just starting out can learn how to break through jargon, learn from lots of different kinds of people, and see problems from different angles. I think the energy and environment fields offer some of the most exciting opportunities to make real and meaningful change over the coming years, and I’m incredibly optimistic about our next generation of innovators!
Dr. Vajjhala was interviewed by Alexander J. Bandza, Associate, Energy and Environmental and Workplace Health and Safety Law Practices, Jenner & Block LLP
Exploring the E-Suite with Joel Brammeier, President and CEO, Alliance for the Great Lakes
Tell us about Alliance for Great Lakes, including what the organization does and your role.
The Alliance drives the local, state and federal policy reforms and implementation necessary to create a healthy Great Lakes for all people and wildlife, forever. We do this by communicating our thought leadership on issues, building powerful networks of influencers, and educating and activating tens of thousands of volunteers, advocates and donors each year who bring their voices to our priorities.
As President and CEO of the Alliance, I concentrate on three principal responsibilities. The first is making sure that the Alliance is focused on the most significant issues affecting clean water in the Great Lakes. That involves a lot of listening, reading, and prioritizing our work. Second, I focus on the financial viability of the Alliance. Fundraising is is my time to listen to what is important to our supporters and communicate to them how their investment in clean water is impacting the Great Lakes. Finally, I work to support the core components of the Alliance—our staff, our volunteers, and the Board of Directors. Everyone needs to be fully engaged, informed, and moving forward to advance the Alliance’s mission.
What is your professional background that you led you to become involved in policy issues concerning protection of fresh water assets and related environmental issues?
After undergrad at Valparaiso University and grad school at University of Michigan, I moved to Chicago in the late 1990s to follow the person who eventually became my spouse. At that time, I began volunteering with a number of NGOs in the Chicago area in order to build my network of relationships and assess how I could become professionally involved. I carried a deep values commitment to non-profit service, mostly due to observing the work of my parents as a teacher and member of the clergy. I had decided on focusing on environmental work in high school after a variety of positive outdoor experiences with my family. After about a year volunteering in various capacities in Chicago, an entry-level position opened up with a group called the Lake Michigan Federation. The combination of my personal value for the Great Lakes that was imprinted on me in childhood, along with my expertise from my education and volunteering, was enough to get me the job. Since that time, I have advanced through the growth and expansion of the organization to become the president of the Alliance for the Great Lakes.
What do you think are the emerging policy issues regarding fresh water assets and the environment of the Great Lakes and how do you think they should be addressed?
It is still all about clean water, but in a much more inclusive and equitable way than is traditional for the mainstream environmental movement. The greatest emerging challenge is how to ensure Great Lakes water is protected and restored in a way that matters personally to all the people of the Great Lakes. For example, drinking water protection is commonly a top reason the public cites as a reason to protect the Great Lakes. The Great Lakes Water Resources Compact & Agreement is a monumental agreement among the states and provinces to ensure water is not diverted to far-flung locations, and that the natural hydrology of the lakes is protected. But this policy doesn’t ensure people can actually access safe, clean and affordable drinking water. It is not credible to say a large natural source of drinking water is truly protected if millions of people who rely on that water cannot safely or reliably use it. And this is today’s unfortunate reality, from manure contamination in northeast Wisconsin, to toxic algae in Lake Erie, to lead and PFAS contamination across the region. Often those harms are falling on people who are already suffering an outsize burden in other parts of their lives.
On specific issues, I think the greatest challenges are 1) changing how we grow food so the agricultural economy does not pollute our water 2) restoring the vital water infrastructure that is the basis of people’s health and the Great Lakes regional economy and 3) preventing the continued influx of invasive species that threaten to torpedo our way of life. Solving these challenges depends on a broad and engaged public that is motivated to action to protect the Great Lakes.
What do you enjoy most about your work at the Alliance for the Great Lakes?
The people I work with, the ability to protect something that is personally important to me and the fact that clean water for all people and wildlife is a hard cause to argue against.
What do you find to be the most challenging aspect of your work?
Environmental advocacy works on big problems with many deeply embedded interests and motivations. Changing that system takes time and can be frustrating. The flip side of that is when you are successful, you are changing a system in a lasting way and you know it will benefit people now and well into the future.
What or who helped you succeed as a policy maker and advocate?
I’m not the kind of person who needs or wants to be in the spotlight taking credit, I just want to work smart and get the result I’m looking for. I’ve relied on so many people because this work is by nature collaborative and I would miss many if I named names. But I will mention one. Cameron Davis, who is now a commissioner at Chicago’s Metropolitan Water Reclamation District, gave me my first real shot at being an environmental professional. I’m sure I screwed up plenty while working for him, but he still let me follow him around and listen to him for years. This was fundamental to me learning how environmental policy change happens. I’m truly thankful for that time. I’ve had five Board of Directors chairs in my time leading the Alliance, without whom I never would have been able to figure out how to run an organization. School does not train you for that and board leadership is vital. The Alliance is fortunate to have a large and diverse base of financial supporters, and I reflect constantly on my obligation to them to make sure our work is addressing their desire for clean and safe water.
Describe those projects as an environmental policy advocate of which you are the proudest.
I’ve done some transformative work in invasive species prevention where I can look back at policies and decisions by elected officials and know that I was one of the people at the center of making those things happen. If you get to be part of one thing like that in a lifetime, it’s pretty great. I’ve been a core part of, though definitely not the leader, of a successful movement to make the Great Lakes a national priority in the United States. I’m also quite proud of dramatically expanding the reach of my organization and becoming a leader in engaging people in advocacy, as public support is critical for success.
What advice would you give a young person today who is considering starting out in your field?
Looking back, I realize today that I received a privileged opportunity when I joined the Lake Michigan Federation. It was a relatively small group rebounding from a tough time in the right way, and I was fortunate to get that job. Today, the green & blue movement is pervasive in our economy and culture in a way that just did not exist twenty years ago. Young professionals can and should seek out careers with environmental organizations, but also remember that there are opportunities to shape systems change throughout the private sector. They should ask their future bosses to communicate their personal vision for change. Look for somewhere in your work where you can take the lead on at least one thing that is important to you and your career. Listen to understand how environmental choices affect the daily lives of people and build your work around that knowledge. And consider spending some time in politics early on – understanding what motivates our decision makers is absolutely critical to devising strategies to make sure the right decisions are made.
Mr. Brammeier was interviewed by Gabrielle Sigel, Co-Chair, Environmental and Workplace Health and Safety Law Practice, Jenner & Block