On Friday, April 30, 2021, the Biden Administration’s Environmental Protection Agency (EPA) announced significant steps the agency intends to take under the Toxics Release Inventory (TRI) Program to implement expanded reporting requirements for companies that store and utilize hazardous chemicals, including new obligations to report the storage, use and any releases of ethylene oxide, a commonly used industrial chemical and sterilant for medical equipment and supplies. The TRI Program, which was established under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), serves as a resource for the public to learn about annual chemical releases, waste management, and pollution prevention activities reported by nearly 22,000 industrial and federal facilities. Under the TRI Program, U.S. facilities operating in various industry sectors must report annually the quantity of certain chemicals they release to the environment and/or manage through recycling, energy recovery and treatment. A “release” of a chemical in the context of the TRI Program means that the chemical is emitted to the air or water, or placed in some type of land disposal.
A major component of EPA’s announcement is the agency’s intent to regulate ethylene oxide. The use and release of ethylene oxide by medical device sterilization companies have prompted a number of recent high-profile lawsuits alleging that releases of the chemical into the environment have caused increased cancer rates in communities adjacent to the facilities. EPA’s announcement notes that many existing sterilization facilities “are located near areas with Environmental Justice concerns,” and that individuals living adjacent to these facilities may be at a heightened risk from exposure to ethylene oxide. “Every person in the United States has a right to know about what chemicals are released into their communities,” EPA Administrator Michael S. Regan stated. “By requiring new and more data on chemical releases from facilities, EPA and its partners will be better equipped to protect the health of every individual, including people of color and low-income communities that are often located near these facilities but have been left out of the conversation for too long.” In the coming months, EPA will provide further details regarding the specific actions the agency intends to take to require sterilization facilities that use ethylene oxide to report under the TRI Program.
In addition to implementing new reporting requirements for companies utilizing ethylene oxide, EPA announced several other steps the agency plans to take that will increase reporting and public access to information under the TRI Program, including:
- Finalizing a longstanding proposed rule that will add natural gas processing facilities to the industry sectors covered under the TRI Program thereby increasing the publicly available information on chemical releases and other waste management activities of TRI-listed chemicals from this sector;
- Continuing to add new per- and polyfluoroalkyl substances (“PFAS”) to the list of chemicals that require reporting under the TRI Program, including the addition of perfluorobutane sulfonic acid (PFBS) following EPA’s toxicity assessment of the substance;
- Proposing a new rule to add high-priority substances under the Toxic Substances Control Act (TSCA) and chemicals included in the TSCA workplan to the list of chemicals that require reporting under the TRI Program; and
- Increasing public access to TRI data through improved search functionality and improved website interface.
EPA’s announcement marks the most recent step by the agency to implement the Biden Administration’s focus on environmental justice as a top priority of its environmental agenda. On the same day that EPA announced the agency’s updated TRI policy, EPA circulated a memorandum to all EPA-staff, indicating the additional actions the agency intends to take to fulfill its environmental justice commitment. These actions include: (1) increasing inspections of facilities that pose the most serious threats to overburdened communities; (2) focusing on implementing remedies that benefit communities, including through the incorporation of supplemental environmental projects; (3) increasing communications with overburdened communities to develop improved cleanup and non-compliance solutions; and (4) identifying locations where state regulators are not adequately protecting local communities and taking increased enforcement actions to “pick up the slack” if state regulators have not taken appropriate or timely actions.
The Corporate Environmental Blog will continue to follow developments on this issue in the coming months as EPA provides additional details on the specific actions it intends to take to expand the TRI Program.
On August 30, 2020, the California legislature passed the Toxic Free Cosmetics Act making California the first state to ban certain chemicals from cosmetics. Governor Newson signed the bill into law on October 1, 2020. The new law amends existing regulatory programs in California and provides that cosmetics containing any of a specific list of 24 chemicals will be considered “adulterated” and therefore unable to be sold in California. The specific list of chemicals includes certain phthalates and formaldehyde. However, the chemicals that have received the most attention are various per- and polyfluoroalkyl (PFAS) substances. Although some states have previously implemented legislation banning certain chemicals in cosmetic products (Minnesota banned formaldehyde in certain children’s personal care products; Washington requires that certain chemicals in children’s products be reported), California has become the first state to implement such a broad ban on these listed chemicals in cosmetics generally.
The ban will take effect on January 1, 2025 providing companies with time to take the necessary steps to eliminate any of the 24 listed chemicals from their cosmetic products. Of course, many companies have already taken steps to eliminate these chemicals from their products especially since many of these chemicals are already on California’s Proposition 65 list. However, unlike with Proposition 65 where compliance can be demonstrated by the provision of the requisite warnings, the Toxic Free Cosmetics Act will require elimination of these chemicals (with the exception of unavoidable trace quantities).
We will continue to provide regulatory updates as more states are likely to follow California’s lead in regulating these chemicals in various personal care products.
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.”
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.
On December 23, 2019, New York Governor Andrew M. Cuomo gave conditional approval to a state ban on firefighting foams containing per- and polyfluoroalkyl substances (known as “PFAS”). PFAS, commonly referred to as “forever chemicals” due to their ongoing persistence in the environment, are a family of man-made chemicals commonly found in a variety of products, including food packaging, cookware, stain-resistant clothing, and, in the case of perfluorooctane sulfonic acid (PFOS), many types of firefighting foams. According to the U.S. EPA, PFAS chemicals are not only “extremely persistent in the environment,” but have also been linked to numerous health conditions including cancer in humans.
The legislation (“A445A”) requires the New York Office of Fire Prevention and Control to promulgate regulations that will provide guidance for state agencies and local government to avoid the purchase of firefighting foams containing PFAS compounds and outright prohibits the manufacture of PFAS containing firefighting foams within two years of the effective date of the bill. As a condition to his approval, Governor Cuomo noted that an amendment to the current legislation was needed to allow discretionary use of firefighting agents containing PFAS where no other viable options exist. On the basis of an agreement with the New York legislature to implement these amendments, the Governor conditionally approved the bill.
With the enactment of the legislation, New York becomes the third U.S. state to ban PFAS chemicals behind Washington and New Hampshire. In addition, six other states have enacted some form of partial prohibitions on the use of foams containing PFAS chemicals. In response to the recent state legislation, the FluoroCouncil has affirmed that use of firefighting foam containing PFAS “is credited with saving lives and property” and that use of such foams may be essential for extinguishing fires caused by flammable liquids.
Regulation of PFAS chemicals is also being considered at the federal level. As noted in a prior blog by the Corporate Environmental Lawyer, a federal bill is currently being considered that would require the U.S. EPA to promulgate drinking water standards for PFOS as well as perfluorooctanoic acid (PFOA), another common chemical in the PFAS family. According to the Congressional Budget Office (CBO), the estimated cost of implementing these federal standards across the country are likely to exceed “several billion dollars.” The Corporate Environmental Lawyer will continue to update on forthcoming or pending state and federal legislation regarding PFAS chemicals.
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.
On Tuesday, April 16th, from 12:00 - 1:00 pm CST, Jenner & Block is hosting an interactive webinar that will discuss how environmental claims can arise in many different contexts and how high costs can be avoided. One way to manage the cost of environmental claims associated with historical operations is to pursue coverage under historical (and often pre-pollution exclusion) occurrence-based commercial general liability insurance policies. Our panelists will discuss the nuances and pitfalls that can arise in environmental insurance litigation and creative strategies to maximize recovery. In addition, companies facing environmental risks in their current operations or transactions can also manage environmental risk through a variety of current insurance products. Our panelists will identify current options available to manage environmental risks going forward and provide insight into the costs and benefits of those insurance products.
Jenner & Block Partners Allison Torrence and Brian Scarbrough will be panelists, along with Richard Reich, Managing Director at Aon Risk Services Central, Inc. Jenner & Block Associate Alex Bandza will moderate the webinar.
Please click here to RSVP for this webinar.
New Jersey continues to take an aggressive stance with respect to per- and polyfluoralkyl (PFAS) contamination. On March 25, 2019, the New Jersey Department of Environmental Protection (NJDEP) issued a “Statewide PFAS Directive Information Request and Notice to Insurers” to five major chemical companies notifying those companies that NJDEP believed them to be responsible for PFAS impacts to the air and waters of New Jersey. In addition to seeking recovery from these companies for past costs incurred by NJDEP to investigate and remediate PFAS impacts, the Directive also seeks to compel these companies to assume responsibility for ongoing remediation of drinking water systems throughout the state. The Directive further seeks information from these companies regarding historical PFAS manufacturing practices as well as information regarding these companies’ ongoing efforts to manufacture PFAS replacement chemicals.
Although environmental organizations have been quick to praise the NJDEP Directive, in reality, the state agency may have overstepped its authority. NJDEP has been quick to point out that the Directive is not a final agency action, formal enforcement order, or other final legal determination and therefore cannot be appealed or contested. Notwithstanding NJDEP’s efforts to insulate its Directive from immediate legal challenge, it will almost certainly draw strong industry challenges. For example, NJDEP’s efforts to obtain information regarding PFAS replacement chemicals may run afoul of the Toxic Substances Control Act and its efforts to compel reimbursement of past claims and/or the takeover of ongoing remedial actions will certainly be the subject of court challenges.
Continuing its full court PFAS press, on April 1, 2019, New Jersey unveiled a proposed drinking water standard of 14 parts per trillion (ppt) for PFOA and 13 ppt for PFOS. These proposed drinking water levels are significantly lower than the current U.S. EPA health advisory level of 70 ppt for combined PFOS/PFOA.
The term “climate change litigation” has become a shorthand for a wide range of different legal proceedings associated with addressing the environmental impacts of climate change. Plaintiffs in climate change lawsuits may include individuals, non-governmental organizations, private companies, state or local level governments, and even company shareholders who, through various legal theories, allege that they have been harmed or will suffer future harm as a direct result of the world’s changing climate. The targets of climate change litigation have included individual public and private companies, government bodies, and even entire industry groups. While there appears to be no shortage of plaintiffs, defendants, or legal theories emerging in climate change litigation, one clear trend is that the number of these lawsuits has grown dramatically in recent years. By one count, more than fifty climate change suits have been filed in the United States every year since 2009, with over one hundred suits being filed in both 2016 and 2017.
In light of the growing trend of climate change litigation, Jenner & Block’s Corporate Environmental Lawyer blog is starting a periodic blog update which will discuss the emerging trends and key cases in this litigation arena. In each update, our blog will focus on a sub-set of climate change cases and discuss recent decisions on the topic. In Part 1 of this series, we will be discussing Citizen-Initiated Litigation Against National Governments.
OSHA’s Directorate of Enforcement Programs recently issued an enforcement memorandum to all OSHA Regional Administrators providing a new “Enforcement Policy for Respiratory Hazards Not Covered by OSHA Permissible Exposure Limits” (“Enforcement Policy”). OSHA’s 2003 policy on the same topic is now superseded and archived.
The Enforcement Policy explains how and when OSHA will cite an employer for respiratory hazards from an air contaminant under the OSH Act’s General Duty Clause (“GDC”). The GDC is the statutory requirement that an employer “furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm.” 29 U.S.C. § 654(a)(1). By regulation, OSHA has stated that “An employer who is in compliance with any standard in this part shall be deemed to be in compliance with the requirement of section 5(a)(1) of the Act, but only to the extent of the condition, practice, means, method, operation, or process covered by the standard.” 29 CFR 1910.5(f). There is an open question as to whether and when an employer is in violation of the law if either (a) OSHA has not set a regulatory exposure limit for a particular chemical; or (b) exposures are below OSHA’s regulatory Permissible Exposure Limit (“PEL”), but above another organization’s recommended occupational exposure limit (“OEL”) for the same chemical. An OEL can be issued by, for example, an industry group, U.S. EPA, the National Institute for Occupational Safety and Health, or the American Conference of Governmental Industrial Hygienists.
OSHA’s new Enforcement Policy states that a GDC violation for airborne chemical exposures cannot be alleged unless OSHA can meet the 4-element standard of proof imposed by the courts for any GDC violation:
A recent decision by the U.S. District Court for the District of Alaska rejected efforts by the Center for Biological Diversity (the “Center”) to challenge the constitutionality of the Congressional Review Act (CRA). The CRA, which was originally enacted in 1996, allows for Congressional disapproval of rules promulgated by administrative agencies under limited circumstances. Historically, the CRA had been used sporadically, but the current Congress has relied on the CRA on at least 16 occasions to roll back Obama administration regulations, and more CRA resolutions may be on the horizon.
In Center for Biological Diversity v. Zinke, the Center challenged the use of the CRA to invalidate a Department of Interior (DOI) rule which limited certain hunting and fishing practices on Alaskan National Wildlife Refuges. More specifically, the Center argued that the CRA unconstitutionally allowed Congress to alter DOI’s authority without using bicameralism and presentment to amend the underlying statutes that gave DOI its authority over the National Wildlife Refuges in Alaska. The Center also argued that the CRA’s prohibition on the issuance of a future rule in “substantially the same form” violates the separation of powers doctrine.
The district court dismissed the Center’s lawsuit, finding that “Public Law 115-20 was passed by both the House and the Senate and submitted to the President for approval as required by the CRA—which was also passed by both houses of Congress and signed into law by the President. Thus, the requirements of bicameralism and presentment are met and [the Center’s] separation of powers concerns fail to state a plausible claim for relief.” The court further noted that “[a]ny injury caused by DOI’s inability to promulgate a substantially similar rule, in the absence of any assertion that DOI would otherwise do so, is too speculative to constitute a concrete or imminent injury and is insufficient to confer Article III standing.” The court also noted that even if the Center could establish an “injury in fact,” the Center had not adequately alleged how invalidating the CRA would redress the Center’s alleged injuries.
Although the CRA remains in full force and effect, one might wonder whether it will retreat back into the shadows at least until the next administration. The conventional view had been that Congress only has 60 days after a rule takes effect to pass a CRA resolution disapproving it. However, lawmakers in Congress are advancing a more novel interpretation of the CRA to review (and potentially disapprove) older rules (and guidance). If a rule or guidance was not officially “submitted” to Congress for review (and many apparently have not officially been submitted), then the current administration could now submit them for review which would restart the 60-day clock. For example, in April, the Senate voted to disapprove a 2013 Consumer Financial Protection Bureau guidance on auto loan financing. The House has not yet taken action on the resolution. If, however, the guidance were to be disapproved under the CRA, then the effect of that disapproval is that the agency will be unable to enact a “substantially similar” rule or guidance. That is really the true power of the CRA, and word is that members of Congress are reviewing older rules and guidance that could be the target of a CRA resolution. Whether the CRA remains a powerful tool this far into the Trump administration remains to be seen, but one can expect that the Center’s constitutional challenge to the CRA is unlikely to be the last.
As 2017 draws to an end, we wanted to thank everyone that follows our Corporate Environmental Lawyer blog. 2017 has been an interesting year and we have enjoyed providing information on critical environmental, health and safety issues for the regulated community. As part of the year in review, we thought it might be interesting to highlight the most popular posts from each of the four quarters in 2017.
- Trump Administration: 2017 Insights
- New State 1,4-Dioxane Drinking Water Standard-New York Threatens to Take Action if U.S. EPA Doesn’t
- World Water Day: Wednesday, March 22, 2017--Jenner & Block Announces Special Water Series
- Trump Administration Issues Freeze on New and Pending Rules – Halting Dozens of Recent EPA Rules
- Great Lakes Compact Council Holds Hearing on Cities Initiative Challenge to Waukesha Diversion of Lake Michigan Water
- Federal Judge Orders Dakota Access Pipeline to Revise Environmental Analysis; Leaves Status of Pipeline Construction Undecided
- Litigation in D.C. Circuit Court Put on Hold While EPA Reconsiders 2015 Ozone Air Quality Standards
- Attorney-Client Privilege Does Not Protect Communications with Environmental Consultants
- News of OECA’s Demise May be Greatly Overstated
- EPA Announces Proposed Rule to Rescind ‘Waters of the United States’ Rule
- Court Decision Remanding FERC’s Evaluation of GHG Emissions May Derail $3.5B Pipeline
- Hurricane Harvey and Act of God Defense—Viable Defense or Futile Prayer
- Who is in Charge of Protecting the Environment—The Role of U.S. EPA and State Environmental Agencies During a Hurricane
- Shell Latest Target of CWA Climate Change Citizen Suit
- New Climate Change Lawsuit: Publicity Stunt or Reasonable Effort to Protect California Property Owners?
- Cities Risk Ratings Downgrade for Failure to Address Climate Change Risks
- Dumpster Diving Results in $9.5M Penalty Recovery for California
- Following Keystone Pipeline Oil Spill, Judge Orders Parties to Prepare Oil Spill Response Plan for Dakota Access Pipeline
- EPA Publishes Proposed Rule on Reporting Requirements for the TSCA Mercury Inventory
- Imagine a Day Without Water
We look forward to continuing to blog on breaking environmental, health and safety issues and we are sure that we will have plenty to blog about in 2018. Warmest wishes for a wonderful holiday season.
Steve Siros and Allison Torrence
On Tuesday, November 14, 2017, from 12:30 - 1:30 PM CST. Jenner & Block Partner Steve Siros and Jaana Pietari, PH.D., P.E., Exponent, will present a free webinar titled “What’s Over the Horizon: Emerging Contaminants of Concern.”
Contaminants of Emerging Concern (CECs) fall into many classes, and encompass an evolving number of chemicals from industrial solvents to pharmaceuticals to endocrine disruptors. CECs may be truly “emerging” chemicals that were previously unregulated, or they may be currently regulated chemicals that have been found to be more toxic or persistent and are subject to new or proposed regulations.
In the absence of federal statutes, varying state standards and advisories create a regulatory minefield for the regulated community. Two examples of CECs receiving increased regulatory and public scrutiny are 1,4-dioxane and poly- and perfluoroalkyl substances (PFAS). Although its presence has been known for nearly a decade, 1,4-dioxane has recently become a more frequent regulatory driver in groundwater cleanups and resulted in reopening previously closed sites. PFAS, on the other hand, are only recently emerging as CECs as new information about the toxicology, health effects, persistence, and systemic presence of this large group of widely used synthetic chemicals is discovered.
The purpose of this webinar is to describe current legal, scientific, and technical issues concerning CECs with a focus on groundwater remediation.
This webinar will:
- Examine legal issues including potential affected parties, the ability of regulators to reopen previously closed sites, and the potential liabilities that can result in the absence of clear regulatory standards.
- Describe scientific developments regarding human health and environmental effects and advances in detection and monitoring of select CECs.
- Discuss key technical aspects regarding challenges in treatment and source identification.
- Provide case studies highlighting the critical legal, scientific, and technical issues in addition to recommendations on risk mitigation opportunities.
To register for the free webinar, click here.
By Andi Kenney
On October 26, 2017, EPA published a proposed rule requiring manufacturers and importers of mercury and mercury-added products or any other person who intentionally uses mercury in a manufacturing process to provide EPA with both quantitative and qualitative information about the elemental mercury and mercury compounds involved in their activities. 82 FR 49564 (October 26, 2017).
Under Section 8(b)(10)(B) of the Toxic Substances Control Act (TSCA), EPA must publish an inventory of mercury supply, use, and trade in the United States” in 2017 and every year thereafter. This reporting rule is authorized by Section 8(b)(10)(D) of TSCA which requires covered persons to provide EPA with the information the Agency needs to prepare that inventory.
The list of potentially affected industries is wide ranging and includes, among many others, mining, chemical manufacturing, plastics and resin manufacturing, medicinal and pharmaceutical manufacturing, coating and adhesive manufacturing, tire and rubber product manufacturing, fabricated metal products (including ammunition) manufacturing, circuit board and semiconductor manufacturing, office and industrial equipment manufacturing, watch and measuring equipment manufacturing, lighting and household appliance manufacturing, battery and electrical equipment manufacturing, boat and RV manufacturing, toy and jewelry manufacturing, and hazardous and non-hazardous waste facilities.
The reporting requirements focus on those who first manufacture mercury or mercury-added products or otherwise intentionally use mercury in a manufacturing process. The proposed rule would not apply to persons generating, handling or managing mercury-containing waste, unless that person manufactures or recovers mercury and uses it or stores it for use. Nor would it apply to those merely engaged in the trade of mercury, those importing mercury-added products for personal use and not for commercial purposes, those manufacturing mercury incidentally (such as by burning coal) or those importing a product that contains mercury solely as a component in a mercury-added product (such as a toy with a mercury-added battery). It would, however, apply to mercury or mercury-containing by-products manufactured for commercial purposes and to the storage of mercury and mercury-added products after manufacture.
EPA is proposing an initial reporting deadline of July 1, 2019, with subsequent reports due every three years thereafter. Each report would cover only the preceding calendar year.
EPA is accepting comments on the proposed rule until December 26, 2017.
On Thursday, September 14th, from 5 pm to 7 pm, environmental attorneys and professionals will come together for a networking reception at Jenner & Block's offices in Chicago. Complimentary food and drinks will be provided thanks to the event’s sponsors. This is the third year Jenner & Block has hosted this event, which continues to grow every year. Jenner & Block will be joined by a number of bar associations and organizations:
- CBA Environmental Law Committee
- CBA Young Lawyers Section Environmental Law Committee
- ISBA Environmental Law Section
- ABA Section of Environment, Energy, and Resources
- Air & Waste Management Association Lake Michigan States Section
- DRI Toxic Tort and Environmental Law Committee
Jenner & Block partner Allison Torrence is a former Chair of the CBA Environmental Law Committee and will be giving brief welcome remarks.
Details for this event are below. If you would like to join us at this reception, please RSVP here.
Environmental Attorney Reception
September 14, 2017 | 5:00 pm to 7:00 pm
Jenner & Block Conference Center | 45th Floor | 353 N. Clark St. | Chicago, IL 60654
On Thursday, May 11th, from 12-1 pm, Jenner & Block will host a CLE presentation on Environmental Risk: Best Practices in Spotting, Evaluating, Quantifying and Reporting Risk. Business risk associated with environmental issues is an important topic that is often not fully understood by in-house counsel or outside attorneys and consultants. Effectively spotting, evaluating and managing environmental risk plays an important role in the success of a business and should be understood by all environmental attorneys and consultants advising businesses. This program will help you improve your ability to spot, evaluate, quantify and report on risk to provide value for your clients and their businesses.
Jenner & Block is pleased to be joined by members of the CBA Environmental Law Committee and the Air & Waste Management Association.
The presentation will be moderated by Christina Landgraf, Counsel, Environmental, Health & Safety, United Airlines, Inc. and Jenner Partner Allison Torrence. The panel of speakers will include Jenner Partner Lynn Grayson, Kristen Gale, Associate, Nijman Franzetti and Jim Powell, Director, Environmental Permitting, Mostardi Platt.
The CLE presentation will be held at Jenner & Block, 353 N. Clark St., Chicago, IL – 45th Floor, from 12-1 pm. Lunch will be provided starting at 11:45 am. If you are unable to attend in person, you can participate via webinar.
You can RSVP here.
Any questions can be directed to Pravesh Goyal: (312) 923-2643 or email@example.com
Jenner & Block Partners Gay Sigel, Steve Siros, and Allison Torrence will speak at the upcoming program Environmental, Health, and Safety Issues in 2017: What to Expect From the Trump Administration, hosted by Jenner & Block’s Environmental, Workplace Health & Safety Practice Group on Tuesday, March 7 from 12:00 pm to 1:00 p.m. With the Trump Administration beginning to take shape, federal environmental, health, and safety (EHS) policy is certain to shift to the right. This CLE program will provide an overview of the Trump Administration’s actions impacting EHS matters to date and prognosticate on changes that may be forthcoming. You are invited to join us for this special program in person or via webinar. If you plan to participate, please RSVP as indicated below.
When: Tuesday, March 7, 12:00—1:00 p.m. with lunch starting at 11:45 a.m.
Where: Jenner & Block, 353 North Clark, Chicago, IL—45th Floor Conference Center
For more information about the program and to RSVP, please connect here.
As we begin the New Year, we wanted to take a moment to look back at some of the major EHS developments in 2016 and think about what we can expect in 2017.
2016 was a busy year for the Corporate Environmental Lawyer blog, which is now in its sixth year with over 760 posts. In 2016, we had nearly 100 blog posts from 10 different authors and over 6,700 visits to the site.
Our five most popular blogs from 2016 were:
EPA Lacks Authority to Regulate Plastic Microbeads in Water, by E. Lynn Grayson
Court Orders New EPA Spill Prevention Rules, by E. Lynn Grayson
Navigating Hawkes, the Newest Wetlands Ruling from the Supreme Court, by Matt Ampleman
ExxonMobil, 13 State Attorneys General Fight Back Against the Exxon Climate Probes, by Alexander J. Bandza
As always, we are monitoring a variety of issues that are important to you and your business, including, for example, RCRA regulatory changes, the future of climate change regulation, implementation of the TSCA Reform Act, and new developments in environmental litigation. You can find current information about these developments and more on the Corporate Environmental Lawyer blog. If you don’t find what you are looking for on our blog, we welcome your suggestions on topics that we should be covering. In addition, keep abreast of new developments in the EHS area through our Twitter @JennerBlockEHS.
We also look forward to the opportunity to share our thoughts and insights with respect to current EHS issues with you at an upcoming program:
- March 7, 2017, 12:00 pm CT: Environmental, Health, and Safety Issues in 2017—What to Expect From the Trump Administration, by Gabrielle Sigel, Steven M. Siros and Allison A. Torrence
The program will take place at Jenner & Block’s Chicago office and also will be available as a webinar. We will post a formal invitation to the program in a few weeks.
We also invite you to visit our newly redesigned Environmental and Workplace Health & Safety Law Practice website for more information about our practice. We look forward to another exciting year and to connecting with you soon.
Last Friday, White House Chief of Staff Reince Priebus issued a memorandum directing all agencies, including EPA, to freeze new or pending regulations. The freeze effects regulations at a variety of stages of finality. Under the Administration’s direction, the following actions are being taken by EPA and other agencies:
- Regulations that have been finalized but not yet been sent for publication in the Federal Register will not be sent until reviewed by someone selected by the President.
- Regulations that have been sent to the Federal Register but not published will be withdrawn.
- Regulations that have been published in the Federal Register but have not reached their effective date will be delayed for at least 60 days for review (until March 21, 2017).
Following through on this direction, EPA released a notice that will be published in the Federal Register on January 26, 2017, delaying implementation of all published rules that have yet to take effect until at least March 21, 2017. The delayed rules include EPA’s Risk Management Program (RMP) facility safety rule, the 2017 Renewable Fuel Standard (RFS) targets, and the addition of vapor intrusion to Superfund NPL site scoring.
By E. Lynn Grayson:
The Department of Homeland Security (DHS) continues to implement recent changes to the Chemical Facility Anti-Terrorism Standards (CFATS) program. DHS updated its data platform and portal that will require regulated facilities to resubmit the Top-Screen information that originally was submitted in the 2008 time frame.
The DHS last year issued notice in the Federal Register (81 FR 47001, July 20, 2016) announcing revisions to its CFATS program, effective October 1, 2016. The main objective of the notice was to advise that the DHS was transitioning to revised versions of the applications for the Chemical Security Assessment Tool (CSAT), the CSAT Security Vulnerability Assessment (SVA) and the CSAT Site Security Plan (SSP). DHS implemented a three-step process to transition to these new versions: 1) temporarily suspended, effective July 20, 2106, the requirement for CFATS chemical facilities of interest to submit a Top-Screen and SVA; 2) replaced the current applications with CSAT 2.0 beginning in September 2016; and 3) reinstated the Top-Screen and SVA submission requirements effective October 1, 2016.
At this time, regulated facilities do not need to take any action unless notified by DHS. DHS began sending out notices to individual facilities every two weeks once the roll-out started in October 2016. Each batch of notifications will include sites from all risk-based tiers and also will include sites that have previously tiered out or are otherwise exempt from CFATS.
Other key highlights and insights include:
- While there is no requirement to do so, regulated facilities may choose to proactively resubmit a Top-Screen utilizing the new CFATS CSAT. Once notified, facilities will have 60 days to submit this updated and/or new Top-Screen.
- No changes have been made to the Appendix A identifying the chemicals of interest (COI) and the associated screening threshold quantity (STQ).
- CSAT 2.0 makes some changes in terms of how and when information is reported. For example, information previously collected through the SVA now may be collected through the Top-Screen. Other information collected in the past in the SVA now will be collected in the SSP.
- The new online SSP will come partially pre-populated from the new Top-Screen and the new SVA submissions as well as information from previous submissions.
In general, CFATS requires chemical facilities report COIs at or above the STQ through submission of a Top-Screen to DHS. Thereafter, DHS decides whether to impose security requirements upon the facility at issue. CFATS requirements apply to facility owners and operators that possess, consume, sell or create various chemicals that could be useful to conducting a terrorist event. There are over 300 COIs including commonly used chemicals such as ammonia, propane, hydrogen peroxide, flammables, bromine, aluminum, nitric oxide and vinyl chloride. Original compliance deadlines for submission of Top-Screen information was in 2008 time frame.
Facilities that previously submitted a Top-Screen survey, even those previously determined to be exempt from the CFATS requirements, will be required to resubmit the Top-Screen information using the new data CSAT 2.0 platform and portal. DHS will notify each facility about these new requirements and facilities will have 60 days to submit the new Top-Screen information. Facilities are welcome to be proactive and submit an updated Top-Screen prior to any DHS notification.
For further insight into these new requirements, please see the Federal Register notice at https://www.federalregister.gov/documents/2016/07/20/2016-16776/chemical-facility-anti-terrorism-standards or visit the CFATS program website at https://www.dhs.gov/chemical-facility-anti-terrorism-standards .
The Occupational Safety and Health Administration (OSHA) published a final rule on Occupational Exposure to Beryllium in the Federal Register on January 9, 2017. The final rule reduces the permissible exposure limit (PEL) for beryllium to 0.2 μg/m3, averaged over 8-hours. The previous PEL for beryllium, established more than 40 years ago, was 2.0 μg/m3. The rule also establishes a new short term exposure limit for beryllium of 2.0 μg/m3, over a 15-minute sampling period.
As we discussed previously on this blog, OSHA proposed this rule on August 7, 2015 and took extensive public comment before issuing this final version. OSHA estimates that approximately 62,000 workers are exposed to beryllium in their workplaces and that the rule will save almost 100 lives from beryllium-related diseases and prevent 46 new cases of chronic beryllium disease each year, once the effects of the rule are fully realized.
On December 7, 2016, EPA published a proposed rule to ban certain uses of trichloroethylene (TCE) under section 6(a) of the Toxic Substances Control Act (TSCA) due to risks to human health from those uses. The proposed rule would prohibit the manufacture (including import), processing, distribution in commerce and commercial use of TCE for aerosol degreasing and for spot cleaning in dry cleaning facilities.
As we previously reported on this blog, EPA recently included TCE on its list of the first 10 chemicals it will evaluate broadly for potential risks to human health and the environment pursuant to requirements of the 2016 TSCA Reform Act. In a 2014 risk assessment, EPA identified serious risks to workers and consumers associated with TCE uses, concluding that the chemical can cause a range of adverse health effects, including cancer, development and neurotoxicological effects, and toxicity to the liver.
On November 29, 2016, EPA announced the first 10 chemicals it will evaluate for potential risks to human health and the environment under the new Toxic Substances Control Act (TSCA) Reform Act, which was signed into law back in June. The TSCA Reform Act required EPA to publish this list of priority chemicals and begin the risk evaluation process on these chemicals by December 19, 2016. By the end of 2019, EPA will be required to have at least 20 chemical risk evaluations in process at any given time.
The first 10 chemicals to be evaluated by EPA are:
Cyclic Aliphatic Bromide Cluster
Pigment Violet 29
Tetrachloroethylene, also known as perchloroethylene
This list will be published in the Federal Register in the coming weeks, at which point it will trigger several statutory deadlines for these 10 chemicals:
- EPA must release a scoping document for each chemical within 6 months.
- EPA must complete risk evaluations for each chemical within three years.
- If the risk evaluation determines that a chemical presents an unreasonable risk to humans and the environment, EPA must mitigate that risk within two years.
More information on the TSCA Reform Act and EPA’s recent actions can be found on EPA’s website.
Mayor Rahm Emanuel and Cook County Board President Toni Preckwinkle recently launched an unprecedented effort to generate new industrial investment in Chicagoland neighborhoods. The Industrial Growth Zones program will accelerate neighborhood development in seven designated areas over the next three years by removing longstanding hurdles to development and providing a broad set of services to support property owners and industrial businesses. The purpose of the program to spur economic growth and generate real, sustainable jobs by promoting investment and industrial development in Chicago neighborhoods.