By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
In prepared remarks from U.S. EPA chemicals chief Michael Freedhoff that were presented at the Product Stewardship Society’s annual meeting, Freedhoff clearly articulated an intent by the Agency to reverse course and aggressively seek to regulate finished articles under the Toxic Substances Control Act (“TSCA”). Historically, U.S. EPA has focused on the manufacture or import of chemicals and chemical mixtures as opposed to finished articles. However, in her written remarks, Freedhoff focused on articles, stating that the “law is very clear that when a chemical enters the United States, or is distributed or processed in the United States—whether in bulk form or in an article—it can be subject to regulation under TSCA”.
Recent U.S. EPA actions have evidenced an intent by U.S. EPA to begin to regulate articles under TSCA. For example, in January 2021, U.S. EPA published final rules to regulate final persistent, bioaccumulative and toxic (“PBT”) chemicals under Section 6(h) of TSCA—these final rules prohibited the use of some of these PBT chemicals in finished articles. Although U.S. EPA has indicated that it intends to initiate a new rulemaking for these five PBT chemicals and has extended the compliance deadline to March 8, 2022, Freedhoff’s remarks certainly indicate that U.S. EPA intends to rely on its TSCA authority to regulate these finished articles. Another example of U.S. EPA's efforts to regulate articles can be found in the proposed TSCA reporting rule for manufacturers of per- and polyfluoralklyl substances (“PFAS”) compounds. The proposed rule would require persons that manufacture (including import) or have manufactured PFAS chemical substances in any year since January 1, 2011 to report on PFAS uses, production volumes, disposals and hazards. Specifically, there is no exemption in the proposed reporting rule for PFAS in articles and Freedhoff specifically noted that the proposed rule “is another example of the Agency’s use of its authority to propose regulatory requirements applicable to imported articles under TSCA”.
Based on U.S. EPA recent regulatory actions coupled with Freedhoff’s prepared comments, it seems clear that U.S. EPA intends to focus its TSCA regulatory authority on articles. We will continue to track these ongoing regulatory initiatives at the Corporate Environmental Lawyer blog.
Analysis of Recent and Forthcoming State Legislation on Toxic Chemicals in Cosmetics and Personal Care Products and Preemptive Effects of Existing Federal Legislation
According to a report released in February 2021 by the organization Safer States, at least 27 US states will consider proposed legislation to regulate toxic chemicals in 2021. While a large driver of the proposed state laws is growing public concern over drinking water contamination from “emerging contaminants,” including PFAS (per- and polyfluorinated alkyl substances) and 1,4-dioxane, a secondary focus has been to minimize the risk of adverse human health effects from exposure to these toxic chemicals in cosmetics and personal care products. Two states—New York and California—are spearheading these efforts through recently enacted laws to limit or prohibit certain toxic chemicals in cosmetics and personal care products that are set to take effect in 2022 and 2025, respectively. As other states consider their own bills to enact similar regulation of chemicals in cosmetics and personal care products, heightened attention will likely be paid to what extent the existing federal regulation of these products may preempt this new wave of state legislation.
- Federal Regulation of Chemicals in Cosmetics and Personal Care Products
At the federal level, chemicals used in cosmetics and other personal care products are primarily regulated by either the Toxic Substrates Control Act (TSCA) or the Federal Food, Drug, and Cosmetic Act (FD&C Act). While TSCA broadly applies to any “chemical substance,” certain chemicals or uses of chemicals are exempt from TSCA if they are regulated by other federal statutes. Such products include “cosmetics” regulated by the FD&C Act, which are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance.” While the distinction between a cosmetic and personal care product may not always be apparent to the consumer, the difference is crucial with respect to federal oversight of the chemicals contained in the product.
Non-cosmetic, personal care products are regulated under TSCA, as amended by the Frank R. Lautenberg Chemical Safety Act of the 21st Century, which requires the Environmental Protection Agency (EPA) to identify “high-priority chemicals” used in existing commerce and determine whether any current uses of the chemicals “present an unreasonable risk of injury to health or the environment.” Where an unreasonable risk is identified, the EPA has discretion to impose conditions on or outright ban the chemical use. Prior to introducing a new chemical or new use of an existing chemical into commerce, manufacturers are required to provide notice to the EPA so that the agency may assess whether the proposed chemical or use will pose an unreasonable risk. In contrast, chemicals used in cosmetic products are regulated by the Food and Drug Administration (FDA) pursuant to the FD&C Act and generally do not require registration or preapproval by the agency before being introduced into commerce. Moreover, the FDA does not have authority to require a recall where it identifies a potential health hazard in a cosmetic product. However, the FDA does have authority to regulate the labeling of cosmetic products and to outright ban specific ingredients from being used in cosmetics generally.
- State Regulation of Chemicals in Cosmetics and Other Personal Care Products—Newly Enacted Laws and Anticipated Future Legislation
While the regulation of chemicals in cosmetic and personal care products has historically been left to the purview of the EPA and the FDA, in recent years a growing number of states have expressed interest in directly regulating chemicals in cosmetic and personal care products sold within their jurisdictions. In 2019 and 2020, state regulation of these chemicals took a significant step forward as New York and California signed into law two bills regulating chemicals used in cosmetic and/or personal care products. A brief description of both state laws is provided below.
- New York: On December 9, 2019, Governor Cuomo signed into law New York Senate Bill 4389-B/A.6295-A, making New York the first and only state to set a maximum contaminant limit of 1,4-dioxane in consumer products. While there are no direct consumer uses of 1,4-dioxane, the compound may be present in cosmetics and personal care products as a byproduct of the manufacturing process (according to one 2007 Study, approximately 22% of cosmetic and other personal care products may contain 1,4-dioxane). New York’s legislation, which takes effect on December 31, 2022, prohibits the sale of personal care products containing more than 2 ppm of 1,4-dioxane and the sale of cosmetic products containing more than 10 ppm of 1,4-dioxane.
- California: On September 30, 2020, Governor Newsom signed into law the Toxic-Free Cosmetics Act, California Assembly Bill 2762, banning 24 chemicals, including mercury, formaldehyde, and certain types of PFAS, from being used in cosmetic, beauty, and personal care products sold in California. California’s legislation is set to take effect in 2025 and will mark the first state-level prohibition on the various chemicals in cosmetic products.
In addition to New York and California’s recently enacted legislation, there are at least five bills currently being considered by various states that would further regulate chemicals in cosmetic and/or personal care products sold within the respective jurisdictions. A brief summary of these state bills is provided below:
- Connecticut: SB 404—Prohibiting the sale or distribution of consumer products that contain PFAS (currently before the Joint Committee on Public Health).
- Maryland: HB 0643—Prohibiting the sale or distribution of cosmetic products that contain PFAS, mercury, and other chemicals in certain instances (currently passed in both chambers and before the Governor).
- New Jersey: A 189 / S 1843—Prohibiting the sale and distribution of nail salon products that contain dibutyl phthalates, toluene, or formaldehyde (currently before the Assembly Consumer Affairs Committee); A 1720—Prohibiting the sale of hand sanitizers and body cleaning products containing triclosan (currently before the Assembly Consumer Affairs Committee).
- New York: A 143 / S 3331—Creating a list of “chemicals of concerns” known to exist in personal care products, requiring manufacturers of such products to disclose any chemicals of concerns contained in their products and prohibiting the sale of personal care products containing chemicals of concerns after three years (currently referred to Environmental Conservation Committee).
- Federal Preemption of State Laws
As more states continue to adopt new legislation to regulate chemicals in cosmetic and personal care products, manufacturers and/or trade organizations will likely bring preemption challenges to these state regulations. In the context of cosmetic products, the FD&C Act prohibits state or local governments from enacting “any requirement for labeling or packaging of cosmetics that is different from or in addition to, or that is otherwise not identical with” the federal rules. Thus, state laws that do not directly regulate the labeling or packing of cosmetics products but instead regulate the contents of these products will likely not run afoul of the FD&C Act’s preemption clause.
In contrast, state legislation governing chemicals in personal care products may be at a higher risk of being preempted by TSCA. TSCA broadly prohibits the enforcement of any state chemical regulation of a particular substance once the EPA completes a risk evaluation for the substance and either: (1) determines that the chemical will not present an unreasonable risk; or (2) concludes that the chemical presents an unreasonable risk under the circumstances of use, and promulgates a rule that restricts manufacturing or use of the chemical to mitigate the identified risks. Notably, the scope of TSCA’s preemption extends only to chemical uses examined in the EPA’s risk evaluation—meaning that the EPA’s failure to examine the use of a chemical in personal care products would make state regulation fair game. In addition, even where a risk evaluation of a particular chemical has been completed, TSCA will not preempt state laws that (1) only impose reporting, monitoring, or information obligations; or (2) environmental laws that regulate air quality, water quality, or hazardous waste treatment or disposal.
Early insight into the full scope of TSCA’s preemption provisions will likely be provided by anticipated challenges to individual state’s regulation of 1,4-dioxane. As explained above, New York has already taken steps to regulate 1,4-dioxane in personal care products and other states may soon look to follow suit. However, on January 8, 2021, the EPA released its final risk evaluation for 1,4-dioxane under TSCA. See 86 Fed. Reg. 1495. The EPA’s initial risk evaluation identified a number of “use conditions” in which 1,4-dioxane posed an unreasonable risk to occupational workers, but did not consider “use conditions” involving 1,4-dioxane’s presence in consumer products. In response to protests from industry, EPA’s final risk evaluation included a supplemental analysis of eight use conditions for 1,4-dioxane as a byproduct in consumer goods, including use in hobby materials; automotive care products; cleaning and furniture care products; laundry and dishwashing products; paints and coatings; and spray polyurethane foam. No unreasonable risks for these consumer uses were identified. Because the EPA’s supplemental risk evaluation examined but did not find any unreasonable risks from 1,4-dioxane in consumer products, an argument could be made that states are preempted from enacting their own 1,4-dioxane limits in consumer products. However, because the EPA’s risk evaluation did not specifically exclude cosmetic or personal care products, individual states may be able to argue that the preemption scope is limited only to the specific uses of 1,4-dioxane that were specifically examined during EPA’s risk evaluation. The resolution of any challenges to New York and other states’ regulation of 1,4-dioxane in consumer products will likely provide key insights into the scope of TSCA’s preemption powers.
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.
By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
A key platform of President Biden’s environmental agenda is increased regulatory scrutiny with respect to chemical substances under the Toxic Substances Control Act (TSCA). Regulating chemicals in order to minimize the threat to human health and the environment is clearly also critical to achieving the aims and goals of Earth Day, especially considering that the publication of Rachel Carson’s Silent Spring helped spark the global environmental movement that eventually culminated in the first Earth Day in 1970.
Turning now to the present, in the waning months of the Trump administration, there was a flurry of U.S. EPA activity under TSCA, including the issuance of risk evaluations for a number of high-priority chemical substances, including asbestos, 1,4-dioxane, and trichloroethylene. Notwithstanding that these risk evaluations concluded that at least some uses of each of the ten high priority chemicals posed an unreasonable risk, these risk evaluations were widely criticized for failing to take into consideration reasonably foreseeable uses or failing to adequately consider various scientific studies. There had been much speculation that President Biden would reject all of the Trump-era TSCA risk evaluations and in fact, one of President Biden’s first actions in the White House was to direct U.S. EPA to review the TSCA risk evaluation process as well as the methylene chloride risk evaluation specifically.
Rather than throwing the baby out with the bathwater, however, U.S. EPA is moving forward to develop risk mitigation plans for each of these high priority chemicals. At the same time, Michal Freedhoff, the acting assistant administrator for U.S. EPA’s Office of Chemical Safety and Pollution, noted that U.S. EPA would be taking a hard look at these risk evaluations. In a prepared statement, Ms. Freedhoff stated:
Our goal is to allow risk management actions on these first ten chemicals to move forward as much as possible, while looking back surgically at specific areas in some of the risk evaluations to supplement them as appropriate in order to ensure we are meeting our statutory obligations and using the best available science to truly protect human health and the environment.
As to the next 20 chemicals in the risk assessment pipeline, U.S. EPA has already announced that it will reassess its TSCA risk evaluation process, including refining its approach for selecting and reviewing scientific studies. U.S. EPA noted that it would not rely on U.S. EPA’s Application of Systematic Review in TSCA Risk Evaluations, a guidance document issued by U.S. EPA in 2018 that was much maligned by the National Academy of Scientists.
One can also expect an increased focus on environmental justice issues by U.S. EPA in connection with evaluating the risks posed by chemical substances. This will most likely play out in connection with an increased focus on chemical substance exposure for fence-line and front-line communities during the risk evaluation process.
Finally, there will also be increasing pressure on the Biden Administration to regulate new emerging contaminants such as per- and polyfluoroalkyl substances (PFAS) under both TSCA and the Safe Drinking Water Act. PFAS compounds have not yet been considered for prioritization under TSCA but are likely to be on a list of high priority chemicals in the future. In the meantime, U.S. EPA is likely to move forward with designating at least PFAS compounds as hazardous substances under CERCLA as well as evaluating whether to set an MCL for these compounds under the Safe Drinking Water Act.
Please check back on Jenner & Block’s Corporate Environmental Lawyer for more Earth Day content throughout the week.
The chemical industry has received some relief from a November 30th deadline to submit information to U.S. EPA pursuant to the Chemical Data Reporting Rule (“CDR”). Section 8(a) of the Toxic Substances Control Act (“TSCA”) authorizes U.S. EPA to promulgate rules pursuant to which manufacturers and processors of chemical substances must maintain records and submit information to U.S. EPA. To that end, U.S. EPA promulgated the CDR that requires entities that manufacture certain chemicals listed on the TSCA inventory in excess of 25,000 pounds annually (lower thresholds apply for certain listed chemicals) to report basic production information to U.S. EPA every four years. The 2020 reporting deadline had been November 30, 2020.
U.S. EPA recently revised the CDR to comply with the 2016 TSCA amendments. These revisions were intended to improve the reliability and usefulness of the data collected and reduce the overall reporting burden on regulated entities. For example, the revised rule allows for the use of data and processing codes based on those already in use by the Organization for Economic Cooperation and Development. The rule also incorporates exemptions for certain byproducts and amends the requirements to claim that the submitted data constitutes confidential business information (“CBI”) (requiring the upfront substantiation of all CBI claims).
On October 26th, the American Chemical Council requested a 60-day extension from the November 30th deadline, noting significant technical issues with the electronic CDR submission platform. Notwithstanding objections from a variety of environmental groups, U.S. EPA has extended the CDR reporting deadline to January 29, 2021. The extension is good news for the regulated community as it works to compile the substantial information necessary to comply with the CDR requirements.
We will continue to track and provide updates on the CDR and other reporting obligations for chemical manufacturer on Jenner & Block’s Corporate Environmental Lawyer blog.
On June 22, 2020, U.S. EPA issued a final TSCA significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances. Specifically, the SNUR designates as a significant new use manufacturing (including importing) or processing of (i) an identified subset of LCPFAC chemical substances for any use that was not ongoing as of December 15, 2015 and (ii) for all other LCPFAC chemical substances for which there were no ongoing uses as of January 21, 2015.
The SNUR also makes inapplicable the exemption for persons who import LCPFAC chemical substances as part of the surface coating on articles (note that the SNUR narrows the scope of affected articles from all imported articles to only those articles that contain such a substance in a surface coating). The SNUR also makes inapplicable the exemption for persons who import PFAS chemical substances in carpets. Persons subject to this SNUR would be required to provide notification to U.S. EPA prior to manufacturing or importing these chemical substances which notification would trigger U.S. EPA’s TSCA review and evaluation of the intended use.
The final SNUR did drop two controversial provisions that would have provided a “de minimis” exemption below which notification would not be required and a “safe harbor” provision that would have allowed article importers to avoid enforcement action if they could demonstrate that their use was ongoing prior to the rule’s effective date.
In response to comments submitted on the proposed “safe harbor” provisions, U.S EPA noted that “[a] safe harbor approach undermines the regulatory process for what uses are allowed by permitting a manufacturer to claim a use was ongoing at the time the SNUR was issued” especially since manufacturers and/or importers were put on notice of the proposed SNUR five years ago.
With respect to the proposed “de minimis” threshold for articles before the notification requirements would kick in, U.S. EPA noted while it was not establishing a de minimis threshold in the final rule, U.S. EPA stated that it “will, however, continue to engage with interested stakeholders on this issue and continue to consider whether guidance for applying this standard may be appropriate in the future, whether as a general matter or, for instance, as applied to specific categories of substances or potential exposures.”
The SNUR will take effect 60 days after official publication in the Federal Register.
White House Promises to Use “All Available Tools” to Implement Deep Cuts to EPA Funding in Fiscal Year 2021
On Monday, February 10, 2020, the Trump Administration released its proposed budget for Fiscal Year 2021. The proposal calls for sweeping cuts to a number of federal agencies and departments, including deep cuts to the United States Environmental Protection Agency (“USEPA”). If enacted, the proposed budget would grant $6.7 billion in funding to USEPA, a $2.4 billion or 26-percent reduction from the agency’s $9.1 billion budget in 2020. In the budget proposal’s preamble, the Administration promises to “call on the Government to reduce wasteful, unnecessary spending, and to fix mismanagement and redundancy across agencies.”
With respect to USEPA’s budget allocation, the proposal promises to “eliminate almost 50 wasteful programs that are outside of EPA’s core mission or duplicative of other efforts, saving taxpayers over $600 million.” Proposed major cuts include the reduction of nearly 50% of the agency’s research budget, including all funding for grants to independent universities and research institutes conducting air, water, and other environmental and health research. Another target for deep cuts is USEPA’s safe drinking water revolving funds. The revolving funds are used to help fund water infrastructure projects undertaken by state or municipal public water providers. Under the proposed budget, the available funds for such projects would be cut from approximately $2.77 billion down to $2 billion.
While the proposal primarily focuses on proposing cuts to USEPA’s fiscal budget, it does contain a few line item requests for additional funding. In particular, the proposal asks for an additional $6 million to carry out USEPA’s Per- and Polyfluoroalkyl Substances (PFAS) Action Plan. The additional funding is sought to continue research into the risk posed by PFAS compounds, address current contamination issues, and effectively communicate findings to the public. In addition, the budget requests $16 million into new research to help prevent and respond to the rising growth of harmful algal blooms.
The budget proposal is not the first time the Trump Administration has sought to implement deep cuts into USEPA’s budget. In fact, the Trump Administration has now proposed nearly identical cuts to the agency’s budget in each of the last three fiscal years. As previously discussed by the Corporate Environmental Lawyer, the Trump Administration first proposed a $2.7 billion budget reduction for USEPA in fiscal year 2018. However, the proposal was rebuffed by congress and the final spending bill ultimately signed by Trump held the agency’s budget at $8.1 billion, even with its 2017 level. The following year, the Trump Administration again proposed cutting the agency’s budget by more than $2 billion, but ultimately agreed to a spending deal that increased the agency’s budget to $8.8 billion. Finally, during fiscal year 2020, the Trump Administration proposed approximately $2.7 billion in cuts to USEPA’s budget. As before, Congress rejected the proposal and ultimately approved a nearly record high budget for USEPA of $9.1 Billion. Congress’ continued rejection of the spending cuts proposed by the Trump Administration is acknowledged in the Administration’s most recent 2021 budget proposal, which derides Congress for continuing “to reject any efforts to restrain spending” and “greatly contribut[ing] to the continued ballooning of Federal debt and deficits, putting the Nation’s fiscal future at risk.” The proposal promises that the Trump Administration will use “all available tools and levers” to ensure that the spending reductions outlined in the budget are finally implemented.
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.
The Trump Administration has released its Fall 2018 Unified Agenda of Regulatory and Deregulatory Actions. This regulatory agenda “reports on the actions administrative agencies plan to issue in the near and long term [and] demonstrates this Administration’s ongoing commitment to fundamental regulatory reform and a reorientation toward reducing unnecessary regulatory burdens on the American people.”
According to the Trump Administration, the regulatory agenda reflects the following broad regulatory reform priorities:
- Advancing Regulatory Reform
- Public Notice of Regulatory Development
- Consistent Practice across the Federal Government
The EPA-specific regulatory agenda lists 148 regulatory actions in either the proposed rule stage or final rule stage, and provides information about the planned regulatory actions and the timing of those actions. Notable regulatory actions under consideration by EPA include:
- Revised Definition of “Waters of the United State”
- Notice of proposed rulemaking planned for October 2019; final rule planned for September 2019
- Definition of “Waters of the United States”–Recodification of Preexisting Rule
- Final rule planned for March 2019
- Clean Water Act Section 404(c) Regulatory Revision
- Notice of proposed rulemaking planned for June 2019
- National Primary Drinking Water Regulations for Lead and Copper: Regulatory Revisions
- Notice of proposed rulemaking planned for February 2019
- National Primary Drinking Water Regulations: Regulation of Perchlorate
- Notice of proposed rulemaking planned for October 2019; final rule planned for December 2019
- Emission Guidelines for Greenhouse Gas Emissions From Existing Electric Utility Generating Units; Revisions to Emission Guideline Implementing Regulations; Revisions to New Source Review Program (a/k/a The Affordable Clean Energy (ACE) rule to replace the Clean Power Plan)
- Final rule planned for March 2019
- TSCA Chemical Data Reporting Revisions and Small Manufacturer Definition Update for Reporting and Recordkeeping Requirements Under TSCA Section 8(a)
- Notice of proposed rulemaking planned for December 2018; final rule planned for October 2019
More information, and EPA's Statement of Priorities, can be found here.
The Frank R. Lautenberg Chemical Safety for the 21st Century Act (a/k/a the TSCA Reform Act), signed into law in 2016, was a major overhaul of the 40-year-old chemical law, reforming how new and existing chemicals are evaluated and deemed “safe.” Since the law’s passage, EPA has completed determinations on 1,602 new chemical cases. EPA has also taken action to ban or restrict use of five existing chemicals, including trichloroethylene (TCE) and methylene chloride, which EPA found to pose heightened risks.
EPA has expended considerable resources over the past two year to fulfil these new review and evaluation requirements. EPA has now taken action to pass some of those costs down to the chemical industry in the form of fees authorized by the TSCA Reform Act.
On September 27, 2018, Acting EPA Administrator Wheeler signed the final Fees Rule, setting out the fees EPA will impose on industry to pay for the costly TSCA review process. The final rule will become effective one day after publication in the Federal Register, which is expected to happen in the next few days.
On Monday, March 5, 2018, EPA issued a report titled EPA Year in Review 2017-2018. The report contains an introductory letter from Administrator Pruitt, who states that he has been “hard at work enacting President Donald Trump’s agenda during [his] first year as EPA Administrator.” The report highlights accomplishments at EPA over the past year, with a focus on the roll back of regulations from the Obama Administration, such as the Clean Power Plan and the Waters of the United States Rule. Administrator Pruitt stated that “[i]n year one, EPA finalized 22 deregulatory actions, saving Americans more than $1 billion in regulatory costs.”
According to the report, Administrator Scott Pruitt set forth a “back-to-basics agenda” with three objectives:
- Refocusing the Agency back to its core mission
- Restoring power to the states through cooperative federalism
- Adhering to the rule of law and improving Agency processes
The report also identifies EPA’s “core mission” as “clean air, land, and water,” and argues that in recent years, “central responsibilities of the Agency took a backseat to ideological crusades, allowing some environmental threats – like cleaning up toxic land – to go unaddressed.” In light of these alleged lapses, EPA states that:
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 September 26, 2017, EPA announced its new Smart Sectors program, a program aimed at easing the regulatory burden on industry. The official notice for this program was published in the Federal Register on September 26th (82 FR 44783), with a correction published on September 29th (82 FR 45586). EPA explained the purpose behind the Smart Sectors program in the notice:
EPA’s Smart Sectors program will re-examine how EPA engages with industry in order to reduce unnecessary regulatory burden, create certainty and predictability, and improve the ability of both EPA and industry to conduct long-term regulatory planning while also protecting the environment and public health.
EPA has initially identified 13 sectors of industry to work with under this program, based on each sector’s potential to improve the environment and public health:
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
The Trump Administration signaled its plans to renegotiate the 1994 North American Free Trade Agreement (NAFTA) by issuing the Summary of Objectives for the NAFTA Renegotiation this month. President Trump committed to renegotiate NAFTA in order to obtain more open, equitable, secure, and reciprocal market access with our two largest export markets in Canada and Mexico.
Environmental considerations currently are managed in a side agreement to NAFTA, but one of the Administration’s priorities is to incorporate environmental provisions into the new NAFTA. The Summary outlines 13 environmental issues to be addressed as part of the renegotiation process:
- Bring the environmental provisions into the core of the agreement, rather than in a side agreement.
- Establish strong and enforceable environmental obligations that are subject to the same dispute settlement mechanism that applies to other enforceable obligations of the agreement.
- Establish rules that will ensure that NAFTA countries do not waive or derogate from the protections afforded in their environmental laws for the purpose of encouraging trade or investment.
- Establish rules that will ensure that NAFTA countries do not fail to effectively enforce their environmental laws through a sustained or recurring course of action or inaction, in a manner affecting trade or investment between the parties.
- Require NAFTA countries to adopt and maintain measures implementing their obligations under select Multilateral Environmental Agreements (MEAs) to which the NAFTA countries are full parties, including the Convention on International Trade in Endangered Species of Wild Fauna and Flora.
- Establish a means for stakeholder participation, including commitments for public advisory committees, and a process for the public to raise concerns directly with its government if they believe it is not meeting its environmental commitments.
- Require NAFTA countries to ensure access to fair, equitable, and transparent administrative and judicial proceedings for enforcing their environmental laws, and provide appropriate sanctions or remedies for violations of their environmental laws.
- Provide for a framework for conducting, reviewing, and evaluating cooperative activities that support implementation of the environmental commitments, and for public participation in these activities.
- Establish or maintain a senior-level Environmental Committee, which will meet regularly to oversee implementation of environmental commitments, with opportunities for public participation in the process.
- Combat illegal, unreported, and unregulated (IUU) fishing, including by implementing port state measures and supporting increased monitoring and surveillance.
- Establish rules to prohibit harmful fisheries subsidies, such as those that contribute to overfishing and IUU fishing, and pursue transparency in fisheries subsidies programs.
- Promote sustainable fisheries management and long-term conservation of marine species, including sharks, sea turtles, seabirds, and marine mammals.
- Protect and conserve flora and fauna and ecosystems, including through actions by countries to combat wildlife and timber tracking.
Critics note that the above environmental considerations look much like the provisions in the now defunct Trans-Pacific Partnership that many environmental advocates opposed.
The first round of talks on the possible renegotiation of NAFTA is scheduled to take place in Washington August 16-20. The Summary confirms that “…the new NAFTA will be modernized to reflect 21st century standards and will reflect a fairer deal, addressing America’s persistent trade imbalances in North America.” While part of the agenda, it does not appear that environmental considerations will be a critical portion of these upcoming negotiations.
Yesterday, the European Chemical Agency (ECHA) released new REACH guidance for companies that import goods containing hazardous substances above 0.1 percent by weight. While aimed at importer notifications, the guidance also addresses registration, notification and communication obligations under the REACH law related to substances in articles.
These REACH requirements apply to 173 “substances of very high concern” contained in goods imported into the EU. The new guidance replaces interim guidance on rules on hazardous substances in products issued by ECHA in December 2015. The guidance also takes into account a European Court of Justice ruling from September 2015 that the 0.1 percent notification threshold for hazardous substances in products should apply to individual components within products, and not only to the whole product.
The new guidance has applicability to an article producer, article importer and article supplier as those terms are defined under REACH. The guidance offers two user friendly tables to assist in interpreting the REACH requirements. These include:
- Table 1: A summary that details the regulatory obligations applicable to producers, importers and suppliers, the legal basis under REACH and possible exemptions that may apply; and
- Figure 1: A flowchart that provides an overview of the process regarding whether and how substances in articles may be regulated under REACH and if so, what obligations are applicable.
For U.S. companies, compliance with REACH presents ongoing challenges and this guidance makes clear that there will be renewed focus on regulatory obligations applicable to importers. According to ECHA, only 365 product notifications covering 39 of the 173 substances of very high concern have been submitted. There is a general belief that many companies are not fully complying with these requirements and that the obligations are not fully understood. The new guidance hopes to provide better direction and a clearer understanding of REACH registration, notification and communication obligations.
The EU REACH import obligations are very similar in nature to existing U.S. TSCA import/export obligations. These, too, have been the subject of confusion and misunderstanding over the years, particularly since these requirements often are managed by shipping and procurement personnel unfamiliar with environmental regulations. EPA’s new TSCA Import Certification Rule also is creating some challenges for U.S. companies particularly in connection with the electronic submissions and certifications now required.
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
A recent case reminds us that not all communications between lawyers and environmental consultants are privileged despite best efforts to make them so. In Valley Forge Ins. V. Hartford Iron & Metal, Inc., the Northern District of Indiana ruled that the attorney-client privilege doesn’t protect a lawyer’s emails to environmental contractors when the communications concern remediation as opposed to litigation. This case provides a good overview of the protections afforded by the attorney-client privilege and the work-product doctrine in the environmental law context.
At issue are Hartford Iron’s communications with environmental contractors Keramida, Inc. and CH2M Hill, Inc. which were the subject of a motion to compel filed by Valley Forge. Following an in camera review of 185 emails, the court concluded that the evidence reflects that “….Hartford Iron retained Keramida and CH2M as environmental contractors for the primary purpose of providing environmental consulting advice and service to Hartford Iron in designing and constructing a new stormwater management system, not because Hartford Iron’s counsel needed them to “translate” information into a useable form so that counsel could render legal advice.”
The Court did find that certain of the emails were subject to the work-product doctrine as the communications were prepared for the purposes of litigation and that IDEM and EPA already had filed suit against Hartford Iron.
Despite the best efforts of lawyers, not all communications are privileged. The legal privileges are narrowly construed and generally do not protect communications with environmental consultants.
This week I published an article in the Chicago Daily Law Bulletin, Trump election puts environment into less than green state. In this article, I discuss my thoughts on environmental issues during the transition from the Obama Administration to the Trump Administration. I specifically address: 1) what authority President Trump has to implement environmental changes; 2) what environmental actions have been taken to date; 3) insights into future environmental changes we are likely to see; and 4) reaction from the environmental community.
If you would like to hear more about what’s happening on the environmental front in the Trump administration, please join us next Tuesday, March 7 at Noon for a program titled Environmental, Health & Safety Issues in 2017: What to Expect From the Trump Administration. My partners Gay Sigel, Steve Siros, and Allison Torrence will be providing the latest updates on what we know and what we can anticipate from the Trump administration in connection with environmental, health, and safety considerations.
If you would like to join us for this program or participate via webinar, please RSVP here.
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.
Friday afternoon, Scott Pruitt was confirmed by the Senate to serve as the Administrator of the U.S. Environmental Protection Agency. 52 Senators voted for Mr. Pruitt’s confirmation, while 46 Senators voted against him. The vote was largely along party lines, with Democratic Senators Heidi Heitkamp of North Dakota and Joe Manchin of West Virginia voting for Pruitt and Republican Susan Collins of Maine voting against him.
As we previously reported here, Mr. Pruitt has been the Attorney General of Oklahoma since his election to that post in 2011. As Oklahoma Attorney General, Mr. Pruitt has sued EPA numerous times to challenge EPA regulations, including current litigation over the Obama Administration’s Clean Power Plan. Oklahoma is part of the coalition of 28 states challenging EPA’s regulation of greenhouse gas emissions from existing power plants – a key component of the Clean Power Plan – in the case of West Virginia v. EPA, Case No. 15-1363. This case is currently pending in the U.S. Court of Appeals for the D.C. Circuit.
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.