The Nickel Report

As Washington, DC readies itself for the new incoming Trump Administration, speculation has already begun regarding what this means for chemical policies, particularly at the US Environmental Protection Agency (EPA).

On September 5, 2024, the US Environmental Protection Agency (EPA) concurrently issued a direct final rule and proposed rule to change the reporting period and submission deadline for its reporting rule for per- and polyfluoroalkyl substances (PFAS) under Section 8(a)(7) of the Toxic Substances Control Act (TSCA).

On July 25, 2024, the US Environmental Protection Agency (EPA) proposed to designate acetaldehyde (CASRN 75-07-0), acrylonitrile (CASRN 107-13-1), benzenamine (CASRN 62-53-3), vinyl chloride (CASRN 75-01-4), and 4,4-methylene bis(2-chloroaniline) (MBOCA) (CASRN 101-14-4) as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA).

States across the country continue to add to the growing patchwork of restrictions for per- and polyfluoroalkyl substances (PFAS) in products, posing challenges for those who manufacture, distribute, and sell products in the U.S. In 2024 alone, states introduced nearly 250 bills addressing PFAS, including restrictions for PFAS in products. Thirteen states have already enacted laws regulating PFAS in products, including (as previously reported) Minnesota and California. In the past few months, Maine, Colorado, Connecticut, Vermont, and Rhode Island have joined the list, each with its own unique and nuanced set of requirements, deadlines and exemptions. The variations in these state laws presents a complicated compliance matrix, necessitating an informed and strategic approach, particularly for companies navigating the complexities of extensive, global supply chains. Below, we provide our analysis of these new laws that companies selling products in these states should be aware of.

Within the first five months of 2024, the United States Environmental Protection Agency (EPA) finalized two rules under section 6(a) of the Toxic Substances Control Act (TSCA) that would impose extensive bans and restrictions on uses of chrysotile asbestos and methylene chloride. Aside from a 2019 EPA rule prohibiting the manufacturing (including importing), processing, and distributing in commerce of methylene chloride for consumer paint and coating removal, these are the first two broadly applicable risk management rules that EPA has promulgated since Congress amended TSCA in 2016 to manage unreasonable risks to human health or the environment through broad restrictions on existing chemicals.

Back in October of 2023, we provided a list of “Frequently Asked Questions” and answers regarding the US Environmental Protection Agency’s (EPA’s) final reporting rule for per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA). As of May 8, 2024, many companies are facing a one-year countdown to the deadline for submitting their reports to EPA. To help you prepare for this impending deadline, we are providing a second installment of “Frequently Asked Questions” and answers about EPA’s rule.

On April 19, 2024, the US Environmental Protection Agency (EPA) released a pre-publication copy of its much-anticipated final rule adding two per- and polyfluoroalkyl substances (PFAS) to the list of “hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund). The rule will be effective 60 days after publication in the Federal Register.

On April 10, 2024, the U.S. Environmental Protection Agency (EPA) released a pre-publication copy of its final rule to establish limits on six per-and-polyfluoroalkyl substances (PFAS) in drinking water under the Safe Drinking Water Act (SDWA). The rule will be effective 60 days after publication in the Federal Register.

On February 21, 2024, the US Environmental Protection Agency (EPA) released its final rule adjusting the fees it collects under the Toxic Substances Control Act (TSCA). EPA is required under TSCA Section 26 to review and, if necessary, adjust the fees every three years to ensure that funds are sufficient to defray part of the costs of administering TSCA. While EPA has significantly increased TSCA fees for manufacturers, importers, and processors of chemicals, it has also finalized new, key exemptions from fee requirements. These new fees will be effective on April 22, 2024.

By March 1, 2024, all establishments that produce pesticides, devices, or active ingredients for pesticides must file their annual production reports for the 2023 reporting year pursuant to Section 7 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 7 U.S.C. § 136e(c)(1). Last year, EPA’s Office of Enforcement and Compliance Assurance reminded stakeholders that the agency is poised to take action against companies that violate FIFRA and noted that non-compliance with the requirements related to producing pesticides and devices by EPA-registered establishments is increasing.

EPA’s plans to investigate – and eventually establish limits on and liability for – PFAS in wastewater discharges and biosolids crossed a significant milestone on January 31, 2024, with the completion of two new analytical methods to detect these ubiquitous contaminants. The most significant of the two is Method 1633, which provides a standardized quantitative method for laboratories to detect 40 different PFAS compounds, at very low levels, in wastewater, surface water, groundwater, soil, biosolids, sediment, landfill leachate, and fish tissue. Method 1621 is a low-cost screening method for the presence of fluorine-containing organic compounds, which could lead to use of the more sensitive Method 1633 to further characterize any PFAS in the sample. EPA’s public statements provide no timeline for seeking approval of these methods for PFAS monitoring of wastewater discharges as part of 40 C.F.R. Part 136, but a Method Update Rule is likely to be proposed before the end of the year.

EPA has big plans for the PFAS data that these two new methods will generate.

In December 2023, federal agencies released their “Fall 2023” Regulatory Agendas that provide an outlook for numerous upcoming regulatory actions on chemicals that could have significant implications for the regulated community. Hunton Andrews Kurth LLP’s chemical regulatory team has provided analyses of these upcoming regulatory actions:

• EPA’s Recent Release of its “Fall 2023” Regulatory Agenda: Upcoming PFAS-Related Actions
• EPA’s Recent Release of its “Fall 2023” Regulatory Agenda: Upcoming Toxic Substances Control Act (TSCA) Actions

In 2022 and 2023, the United States Environmental Protection Agency (EPA) proposed five risk management rules under Section 6(a) of the Toxic Substances Control Act (TSCA) imposing restrictions and bans on chemical uses. This is the first group of risk management rules that EPA has published since Congress amended TSCA in 2016, establishing EPA’s process to address “unreasonable risks” identified for certain uses of existing chemicals. These proposed rules provide a roadmap for EPA’s approach to chemical regulation under Section 6(a), establishing the precedent for future regulation.

Companies should anticipate more proposed bans, especially for consumer uses of a chemical, along with significantly lower chemical exposure limits compared to occupational exposure limits. Rigorous workplace requirements, including exposure monitoring, respiratory protection and additional personal protective equipment (PPE) requirements are also expected. And, the absence of industry data on a chemical’s use may lead to more stringent proposed regulation.

On October 17, 2023, the California Attorney General (AG) Rob Bonta released an enforcement advisory letter to manufacturers, distributors, and sellers of food packaging and cookware detailing how he intends to enforce AB 1200, a law which: 1) bans the sale of regulated per- and polyfluoroalkyl substances (PFAS) in food packaging in California, and 2) requires disclosure and labeling of chemicals on a “designated list,” including PFAS, that are present in the food contact surface or the handle of cookware products sold in California. Because the individual laws do not provide specific enforcement mechanisms, this announcement is the first time the AG’s office has articulated the authorities it plans to use to enforce these laws. The enforcement advisory letter provides a clear warning to the regulated community, from manufacturers to importers to distributors and retailers, that California will be enforcing its PFAS laws. Similar advisories could be issued in the future for California’s other laws restricting PFAS in juvenile products, textiles, and cosmetics.

On October 11, 2023, the US Environmental Protection Agency (EPA) released its long-awaited final rule imposing detailed reporting requirements on entities that have manufactured or imported per- and polyfluoroalkyl substances (PFAS) for commercial purposes at any time since January 1, 2011. Notably, the reporting rule also applies to importers of articles containing PFAS, which could include many consumer, industrial, and commercial products, and requires reporting on PFAS as a component of a mixture. The rule does not have any exclusions for PFAS that are impurities, byproducts, used in commercial research and development (R&D), or only present in a mixture or article in trace amounts. And, unlike many state PFAS reporting laws, this reporting rule is not limited to only intentionally added PFAS.

EPA finalized a rule effective on August 7, 2023 concerning the treatment of confidential business information (CBI) claims made in Toxic Substances Control Act (TSCA) submissions. Companies who submit any information to EPA under TSCA and want their confidential information to be protected from public disclosure must comply with these new requirements for CBI claims. Failure to follow these procedural requirements can result in EPA’s denial of the confidentiality claims and the information being made public.

As states across the country develop laws addressing per- and polyfluoroalkyl substances (PFAS), a patchwork of requirements has begun to emerge, creating challenges for those who manufacture, distribute, and sell products around the country. In 2023, over 200 bills were introduced addressing PFAS, including restrictions for PFAS in products. This trend is expected to continue.

In June 2023, federal agencies released their “Spring 2023” Regulatory Agendas that provide an outlook for numerous upcoming regulatory actions on chemicals which could have significant implications for the regulated community. Hunton Andrews Kurth LLP’s regulatory team have provided analyses of these upcoming regulatory actions:

• EPA’s Spring 2023 Unified Regulatory Agenda—Upcoming PFAS-Related Actions
• EPA’s Spring 2023 Regulatory Agenda—Upcoming TSCA Actions

While liability for PFAS—per- and polyfluoroalkyl substances, also known as “forever chemicals”—may be an emerging issue, the availability of insurance coverage for these and similar liability claims is not. “Commercial general liability,” or CGL, insurance was specifically designed to cover claims made by a company’s customers or customers of customers for resulting bodily injury and property damage. PFAS claims fit this bill. 

Continue reading this article on the Hunton Insurance Recovery Blog.

On June 5, 2023, the US Department of Energy (DOE) published its US National Clean Hydrogen Strategy and Roadmap. This report addresses the Infrastructure Investment and Jobs Act (IIJA) requirement that the DOE “develop a technologically and economically feasible national strategy and roadmap to facilitate widespread production, processing, delivery, storage, and use of clean hydrogen.” Notably, in developing this strategy, Congress instructed the DOE to focus on clean hydrogen production and use from a variety of sources—including natural gas, coal, renewable energy, nuclear energy, and biomass.

In May 2023, Minnesota’s Governor Walz signed into law HF 2310, which bans the sale of certain products containing “intentionally added” per- and- polyfluoroalkyl substances (PFAS) in 2025 and then all products in 2032, and also establishes reporting requirements for products containing PFAS starting in 2026. Following Maine’s lead, Minnesota has now become the second state in the country to pass a broad ban on PFAS-containing products sold in the state. While reporting requirements apply to product manufacturers, the bans on sale, offer for sale, or distribution in the state apply to “persons,” including retailers. Companies who manufacture products for sale (and who sell) products in the state of Minnesota will need to prepare to assess the presence of PFAS in their supply chains in order to comply with these new requirements.

On May 3, 2023, EPA released its proposed risk management rule under Section 6(a) of the Toxic Substances Control Act (TSCA) to impose restrictions on the manufacture, import, processing, distribution, and use of methylene chloride, a widely-used solvent in a variety of consumer and commercial applications. This is the first risk management rule proposed by EPA since it issued revised risk determinations last year based on its new “whole chemical approach” and policy for assuming that personal protective equipment (PPE) is not used by workers. It also reflects a substantial expansion of the regulatory prohibitions applicable to a chemical that was already subject to TSCA risk management restrictions, albeit more limited ones, under EPA’s prior framework for risk management actions.

EPA is proposing to prohibit the manufacture, processing, and distribution in commerce of methylene chloride for consumer use; prohibit most industrial and commercial uses of methylene chloride; require a workplace chemical protection program (WCPP) for certain identified conditions of use that are allowed to continue; and provide certain time-limited, critical use exemptions under Section 6(g) of TSCA for uses of methylene chloride that would otherwise significantly disrupt national security and critical infrastructure. Stakeholders have until July 3, 2023 to comment on the proposed rule.

On March 29, 2023, the US Environmental Protection Agency (EPA) published in the Federal Register its long-awaited proposed rule to restrict certain per- and polyfluoroalkyl substances (PFAS) in drinking water under the Safe Drinking Water Act (SDWA). This action is part of EPA’s whole-of-agency approach in its PFAS Strategic Roadmap and is expected to directly affect 66,000 public water systems across the country. Comments on the proposal are due on May 30, 2023. EPA will also hold a public hearing on May 4, 2023 to receive stakeholder input on this important rulemaking.

In late February 2023, EPA released for public comment its Draft Proposed Principles of Cumulative Risk Assessment under the Toxic Substances Control Act (“Draft Principles”), which proposes a set of principles for evaluating cumulative risks for chemicals undergoing risk evaluation under the Toxic Substances Control Act (“TSCA”). In conjunction with the Draft Principles, EPA also released its “Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer Requested Phthalate Under the Toxic Substances Control Act,” (“Draft Proposed Phthalates Cumulative Risk Approach”), an approach for applying these Draft Principles to the evaluation of cumulative risks posed by certain phthalates undergoing TSCA risk evaluations. EPA referred to these documents as the “first steps” towards the Agency conducting cumulative risk assessments under TSCA.

In February 2023, the US Environmental Protection Agency (EPA)’s Office of Enforcement and Compliance Assurance (OECA) quietly released a Compliance Advisory “What You Need to Know about Producing, Distributing, or Selling Pesticide Devices.” The advisory follows on the heels of similar advisories and provides information to the regulated community about requirements for pesticide devices under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in order to promote compliance. EPA issued this advisory in response to a “significant increase” in the number of pesticide devices being sold or distributed in the US in which EPA has found “substantial non-compliance” with FIFRA requirements. EPA has also experienced a high volume of inquiries from companies and other regulators seeking clarification about pesticide device requirements. The advisory suggests that EPA remains poised to continue taking enforcement actions against companies that import, distribute or sell pesticide devices that do not comply with FIFRA’s requirements.

In January 2023, federal agencies released their “Fall 2022” Regulatory Agendas that provide roadmaps for upcoming and long-term regulatory actions on chemicals that could have significant implications for the regulated community. These agendas make clear that the Biden Administration continues to prioritize regulatory actions to address per- and polyfluoroalkyl substances (PFAS) across multiple agencies. And the US Environmental Protection Agency (EPA) also continues to implement numerous regulatory initiatives to assess and mitigate chemical risks under the strengthened Toxic Substances Control Act (TSCA).

Hunton’s chemical regulatory team has provided analyses of these upcoming regulatory actions:

• EPA’s “Fall 2022” Regulatory Agenda – Upcoming PFAS-Related Actions
• EPA’s “Fall 2022” Regulatory Agenda – Upcoming Toxic Substances Control Act (TSCA) Actions

A Question Every Retailer Must Be Prepared to Answer

Per- and polyfluoroalkyl substances (PFAS) have taken center stage. The Biden administration’s regulatory agenda plans numerous revisions to environmental regulations to address this broad class of pervasive substances. While the US Environmental Protection Agency grapples with implementing these initiatives, states are aggressively forging ahead with their own plans. Laws targeting PFAS in various products have taken effect and will continue to take effect in many states, representing a striking expansion from typical state regulations addressing environmental PFAS contamination from firefighting foam and other sources.

On December 22, 2022, EPA’s Integrated Risk Information System (IRIS) Program released its ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook). EPA began working on the approaches in the IRIS Handbook after a 2011 National Research Council report recommended several improvements to the overall IRIS assessment process. In 2020, EPA released a draft IRIS Handbook for public comment and commissioned a peer review by the National Research Council.

Established in 1985 to ensure Agency-wide consistent toxicity evaluations, IRIS assessments provide chemical toxicity values for noncancer and cancer human health effects resulting from chronic exposure to chemicals. These values are often utilized in EPA regulations under the Clean Air Act (CAA), the Safe Drinking Water Act (SDWA), and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). While chemical risk evaluations conducted under the Toxic Substances Control Act (TSCA) require more information and analysis than that provided by an IRIS assessment, IRIS assessments will likely continue to be used to inform TSCA risk evaluations. State agencies and international bodies also rely on IRIS assessments.

On 6 September, the US EPA released its proposed rule to add perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) to the list of hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), also known as Superfund.

If finalized, these hazardous substance designations could have a significant impact on many industries, from creating new reporting obligations to increased compliance, enforcement and litigation risks related to site cleanup.

Click here to read the full article, published in Chemical Watch.

On August 26, 2022, the US Environmental Protection Agency (EPA) released a pre-publication copy of its much-anticipated proposed rule adding perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) to the list of “hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund). EPA asserts that this regulatory escalation of PFOA and PFOS will facilitate faster cleanup of contaminated sites and reduce exposures to these “forever chemicals.” If finalized, these hazardous substances designations will have significant and immediate impacts on many industries, from creating new reporting obligations to increased compliance, enforcement, and litigation risks related to site cleanup. EPA’s efforts involving PFOA and PFOS fall within the broader, whole-of-agency approach to addressing PFAS first announced in its PFAS Strategic Roadmap and represent its first ever exercise of its authority under CERCLA section 102(a) to designate a hazardous substance.

On July 28, 2022, the US Environmental Protection Agency (EPA)  published the 2021 Toxics Release Inventory (TRI) preliminary dataset that provides public access to data about chemical releases, waste management, and pollution prevention activities that took place in calendar year 2021 at more than 20,000 federal and industrial facilities across the country. The 2021 preliminary dataset, which for the second year includes reporting on per- and polyfluoroalkyl substances (PFAS) added to the TRI by the 2020 National Defense Authorization Act (NDAA), has not yet undergone the complete TRI data quality process. EPA plans to publish the quality-checked dataset in October 2022, at which time it will be the basis for the 2021 TRI National Analysis interpreting the information and examining trends that is expected to be published in early 2023. Companies should bear in mind that information collected under the TRI program can be used not only to inform regulatory action, but also as a basis for enforcement by EPA and citizen suits.

On June 15, 2022, the United States Environmental Protection Agency (EPA) released drinking water health advisories [1] for certain per- and polyfluoroalkyl substances (PFAS), resulting in the establishment of:

1. Near zero updated interim advisory levels for Perfluorooctanoic acid (PFOA) and Perfluorooctane sulfonic acid (PFOS) that are not only orders of magnitude below previously established levels, but that are also below detectable levels and, notably, were issued in advance of completion of peer review by EPA’s Science Advisory Board (SAB); and
2. Newly issued final advisories at low levels for GenX and PFBS chemicals that have been used as replacement chemicals for PFOA and PFOS.

On April 12, 2022, the United States Environmental Protection Agency (EPA) announced a sweeping proposed ban on ongoing uses of chrysotile asbestos, the only form of asbestos known to still be imported into the United States. EPA’s proposed ban is the first risk management rule issued under the Toxic Substances Control Act (TSCA) since the 2016 Lautenberg Act overhauled the statute to give EPA new powers to review and regulate existing chemicals.

On April 5, 2022, the California Office of Environmental Health Hazard Assessment (OEHHA) published a second 15-day notice of modification to its proposed Proposition 65 safe harbor “short-form” warning regulations.  If adopted, the amendments would significantly impact businesses’ use of the short-form warnings.

Does your company manufacture, process, distribute, use, or dispose of fluorinated high-density polyethylene (HDPE) containers and similar plastics? If so, it may be time for supply chain and process reviews aimed at identifying and eliminating possible per- and polyfluoroalkyl substance (PFAS) contamination.

On December 29, the chemicals program at EPA closed out 2021 by proposing revisions to its risk determinations for the Cyclic Aliphatic Bromide Cluster (HBCD), a solvent used as a flame retardant and wetting agent which has not been manufactured in the United States in nearly five years. In doing so, the Biden EPA made good on its June 2021 promise to revisit risk determinations previously made during the Trump Administration in accordance with the Toxic Substances Control Act (TSCA). The draft “revisions” represent a significant shift from EPA’s prior approach to existing chemical risk evaluation and foreshadow increased regulatory and litigation risk for all companies—not just those whose operations may have historically involved HBCD.

With the busy holiday shopping season underway, retailers should remain vigilant in their efforts to protect consumers and themselves from the risks of selling potentially unsafe, ineffective or misbranded products in violation of the U.S. Environmental Protection Agency (EPA’s) federal pesticide law, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).  As concerns with the spread of COVID-19 and new variants increase over the winter months, consumers are likely to stock up disinfectant products and devices like air purifiers and air filters marketed to reduce the transmission of COVID-19 and other microorganisms.  These products are tightly regulated under FIFRA, and retailers can unwittingly become entangled in regulatory enforcement actions for selling and distributing products that do not comply with EPA’s regulations.  FIFRA extends legal liability not only to the makers of violative products, but also retailers who sell them to consumers, whether or not the retailer was necessarily aware of the violation. In addition to EPA, state agencies also enforce state regulatory requirements applicable to these products.

11.22.21 Last week, EPA transmitted four important documents to the EPA Science Advisory Board (SAB) for peer review that included updated health assessments for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS). This peer review, which will start on December 16, will inform EPA’s development of a Maximum Contaminant Level (MCL) Goal and a future, legally enforceable National Primary Drinking Water Regulation for PFOA and PFOS under the Safe Drinking Water Act. As noted in the PFAS Strategic Roadmap: EPA’s Commitments to Action 2021-2024, EPA intends to release a proposed drinking water regulation for PFOA and PFOS in fall 2022. These scientific documents will provide the underpinnings for that important regulation.

This insights column, originally published in Chemical Watch, provides a refresher on the important distinctions between hazard and risk based approaches and discusses them in the context of the findings of the EPA TSCA risk evaluations. The completed TSCA risk evaluations make findings of “no unreasonable risk” or presents “unreasonable risk” for each condition of use evaluated that is evaluated. However, EPA is considering modifying the existing findings, and the approach for future risk evaluations.  This column discusses what this might look like and whether this planned approach is consistent with the 2016 Lautenberg Amendments to TSCA.

 On October 18, 2021, the US Environmental Protection Agency launched its PFAS Strategic Roadmap: EPA’s Commitments to Action 2021-2024 (“Roadmap”)[i] setting forth its “whole-of-agency” approach to address per- and polyfluoroalkyl substances (PFAS). The Roadmap sets forth timeframes for EPA actions to address PFAS across environmental media and under various statutory authorities including the Toxic Substances Control Act (TSCA), Resource Conservation and Recovery Act (RCRA), Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), Safe Drinking Water Act (SDWA), Clean Water Act (CWA) and Clean Air Act (CAA). As such, EPA’s implementation of the Roadmap, including key initiatives rolled out in the days following its release, will affect a broad spectrum of industry sectors and facilities throughout the PFAS lifecycle who may face new and expanded regulatory requirements and obligations.

In a dramatic announcement last week, EPA suggested that if companies import, manufacture, or process a finished good for commercial sale, and that product is not a pesticide, not a firearm, not a tobacco product, and not a food, food additive, drug, cosmetic, or device, they will need to know all chemicals contained in those products. We explain more about this below.

EPA has traditionally declined to extend most of its chemical regulations to finished goods, which are known as “articles” under the Toxic Substances Control Act (TSCA), on the grounds it would be enormously difficult for importers of complex consumer products to determine the chemical identity of each chemical substance in these products. Industry stakeholders have generally supported this approach and have long taken the position that supply chains are too complex to expect finished product manufacturers to be aware of all chemicals in those products.

On August 30th, EPA granted the 2007 Petition from the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) requesting that EPA revoke all chlorpyrifos tolerances. This followed the Ninth Circuit order earlier this year for EPA to: “(1) grant the 2007 Petition; (2) issue a final regulation within 60 days following issuance of the mandate that either (a) revokes all chlorpyrifos tolerances or (b) modifies chlorpyrifos tolerances and simultaneously certifies that, with the tolerances so modified, the EPA "has determined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information," including for "infants and children"; and (3) modify or cancel related FIFRA registrations for food use in a timely fashion consistent with the requirements of 21 U.S.C. § 346a(a)(1).”

8.18.2021 EPA Finalizes Hazard Assessments for Two Fuel Additives (ETBE and tert-Butanol):

On August 18^th, EPA finalized the long-awaited hazard assessments for both Ethyl Tertiary Butyl Ether (ETBE) and tert-Butyl Alcohol (tert-Butanol).  ETBE was previously added to gasoline to increase its octane levels. It is still registered with EPA for use as a fuel additive, but it is not used currently in the United States.  tert-Butanol is one of the primary metabolites of ETBE and has also been used as a fuel oxygenate. It is also used for other purposes including as a solvent and as a dehydrating agent.

In the face of accelerating EPA and state regulatory activity on per- and polyfluoroalkyl substances (“PFAS”)[i], Congress is pressing forward with measures that would address or impose limitations on these “forever chemicals.” More than thirty such legislative measures are currently pending in Congress covering a number of subjects related to PFAS including, but not limited to, those involving military uses, funding assistance, detection and research, product stewardship, site remediation, and regulatory mandates. Of these, the most comprehensive initiative ...

In January, EPA obtained data that some mosquito control pesticides contained detectable levels of certain PFAS.  In a joint investigation with the State of Massachusetts, EPA found that fluorinated high-density polyethylene (HDPE) containers containing a mosquito control pesticide were leaching PFAS into the product. Now, EPA is testing different brands of fluorinated containers to determine whether they contain and/or leach PFAS and has asked the states with existing stocks of these pesticides to discontinue use as EPA evaluates the issue. Information on the EPA activities can be found here. EPA also began working with USDA and FDA to get a better understanding of the use of fluorinated polyethylene containers for pesticides and other products.

Care about Drinking Water Regulations?

7.22.2021 Request for Comment and Public Workshop for California Drinking Water Public Health Goals for PFOA and PFOS: The California Office of Environmental Health Hazard Assessment (OEHHA) released a draft document for public review describing proposed Public Health Goals (PHGs) for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) in drinking water. A PHG is the level of a drinking water contaminant at which adverse health effects are not expected to occur from a lifetime of exposure.  PHGs published by OEHHA are considered by the State Water Resources Control Board in setting drinking water regulatory standards (Maximum Contaminant Levels, or MCLs) for California. The proposed PHG of 0.007 parts per trillion (ppt) for PFOA is based on kidney cancer in humans and the proposed PHG of 1 ppt for PFOS is based on liver and pancreatic tumors in laboratory animals. The draft technical support document can be found here. Public comments are due September 28, 2021. Details about how to send comments and a public workshop that will be held on September 28, 2021 can be found here.

On Wednesday, June 16, 2021, EPA held the first of two public “listening sessions” to inform its review of the Risk Management Program (RMP) regulations pursuant to Executive Order 13990.  According to Carlton Waterhouse, EPA Deputy Assistant Administrator for the Office of Land & Emergency Management (OLEM), the listening sessions are “a first step in considering improvements to the RMP rule, so EPA can better address the impacts of climate change on facility safety and protect communities from chemical accidents, especially vulnerable and overburdened communities living near RMP facilities.”

Last month, EPA announced a planned update of the Toxics Release Inventory (TRI) reporting program, incorporating several additions.  The updates would expand the TRI program by adding new chemicals, facilities, and tools to increase accessibility of data.  The goal, according to EPA’s statement, is “to advance Environmental Justice, improve transparency, and increase access to environmental information.”

On January 26, 2021, a coalition of advocacy groups and prominent asbestos plaintiffs’ experts launched two challenges to “Part 1” of the asbestos risk evaluation recently released by the United States Environmental Protection Agency (EPA).  EPA concluded in Part 1 that 16 of the 32 “conditions of use” analyzed pose an “unreasonable risk” to human health, but advocacy groups have criticized EPA for only addressing risks associated with chrysotile asbestos and excluding review of other fiber types.  Now, those groups have teamed up on a pair of legal challenges that could force EPA to revisit its Part 1 asbestos risk evaluation, which could delay risk management regulations.

A flurry of asbestos-related activity in the last weeks of 2020 will require the United States Environmental Protection Agency (EPA) to devote significant regulatory attention to asbestos in 2021.  The incoming Biden Administration will need to address these Toxic Substances Control Act (TSCA) developments, and the scope of that response will determine whether regulatory implications extend beyond asbestos to other chemical substances.

On November 9, 2020, EPA’s Office of Research and Development (ORD) released its long-awaited draft handbook that details the office’s process for developing chemical hazard assessments for its Integrated Risk Information System (IRIS) Program. The ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook) gives useful insight into ORD’s process to develop its IRIS assessments, which provide important toxicological information that federal and state environmental agencies consider when making regulatory and cleanup decisions under multiple statutory programs. EPA will accept comments on the draft handbook and charge questions until March 1, 2021.

In the age of COVID-19, demand for surface wipes, sprays and similar products is at record levels. Retail stores have struggled to keep supplies stocked and shelves may once again be emptied when the winter flu season arrives. If schools and businesses reopen concurrently, the prospects of securing these products becomes even bleaker, which may re-fuel consumer stockpiling. To meet this surging demand, manufacturers have ramped up production and new entrants are pouring into this market space in unprecedented numbers. Supply chains are already stressed and further straining is expected to continue.

Company Boards of Directors and senior executives of oil and gas companies should take notice of a May 14, 2020, guidance document issued by the Chemical Safety Board (CSB) entitled, “CSB Best Practice Guidance for Corporate Boards of Directors and Executives in the Offshore Oil and Gas Industry for Major Accident Prevention.,”  And don’t be deceived by its title reference to offshore activities.  Companies also need to pay mind to the guidance for onshore operations.  Why?  If there is an accident, government agencies will likely argue that the principles articulated apply equally as well on dry land.

On June 11, 2020, the California Assembly passed the Toxic-Free Cosmetics Act, Assembly Bill (A.B.) 2762 [1], by a bipartisan vote of 54-0.  If enacted by the Senate, the law would be the first in the United States to ban twelve ingredients, including mercury and formaldehyde, from beauty and personal care products sold in California due to toxicity concerns.

This article was originally published on Law360.

On March 11, the U.S. Environmental Protection Agency completed an important rulemaking under Title VI of the Clean Air Act Amendments of 1990, revising its requirements applicable to the management of refrigerants in appliances and industrial process refrigeration.

The rulemaking corrects what the EPA states was an incorrect Obama-era interpretation of the Clean Air Act, that would have allowed the agency to issue sweeping and costly regulations for refrigerants that companies had invested in to alleviate the problem of ozone-layer depletion pursuant to the 1987 Montreal Protocol.

The U.S. Supreme Court ruled today in Atlantic Richfield Company v. Christian that private landowners at a Superfund site near Butte, Montana, can pursue state law claims in state court seeking “restoration damages” for cleanup actions that go beyond the EPA-selected remedial action. The Court also held, however, that these landowners are potentially responsible parties (PRPs) under the federal Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) and, as a consequence, must obtain EPA approval of the restoration plans before they can be implemented. Chief Justice Roberts wrote the Court’s opinion, in which five other justices joined.  Justice Alito wrote a dissenting opinion declining to sign on to the majority’s conclusion “that state courts have jurisdiction [under state law] to entertain ‘challenges’ to EPA-approved CERCLA plans,” taking the position that it was unnecessary for the Court to address this question.  In a separate dissent, Justice Gorsuch, joined by Justice Thomas, disagreed with the conclusion that the landowners were “PRPs” who needed EPA’s approval to conduct more robust cleanup at their properties than otherwise required by EPA.

When I was a kid, Californians, particularly those from SoCal, would be teased for their standard way of saying goodbye to people in person or on the phone – “Have a nice day!” Even in today’s text message society, texts often close with the yellow “smiley face” emoji. There’s been significant debate too about whether this phrase is “rude” by commanding someone to have a nice day rather than as it is largely intended, to wish someone a nice day.

In a COVID-19 world, I’ve found that “have a nice day” has been supplanted by “stay safe.” In just a few weeks, our focus has shifted from a desire for a pleasant experience to a safe one, which recognizes that something many people simply have taken for granted, our health and safety, is not a given in our current world.

Joining a growing chorus of states, several Northeastern states, including Massachusetts, Maine and Rhode Island, have recently announced their intentions to impose a ban on the use of hydrofluorocarbons (HFCs). The looming regulatory actions by these states are generally anticipated to follow an HFC ban rulemaking model established by the members of the US Climate Alliance.[1] It remains to be seen, however, whether the states will look to additional regulatory options, as it was a worldwide product ban in the late 1980s that inadvertently set the stage to now limit alternatives containing HFCs due to their climate forcing potential as a greenhouse gas (GHG).

The Novel Coronavirus Disease (COVID-19) outbreak is affecting virtually every sector of society and the economy. The healthcare sector and government agencies are on the front lines of the response. Providing support to these critical response activities as well as striving to maintain the strength of the overall economy by continuing regular business operations is vitally important. The private sector has important roles to play. The purpose of this blog post is to briefly outline some practical and legal tools available to help provide both direct support and maintain broader economic activities while ensuring environmental protection and compliance with natural resource laws.

This blog post will be updated as new or relevant information becomes available.

Companies that manufacture or import products containing one or more of 20 common chemicals may soon be required to disclose those activities and pay fees to offset the United States Environmental Protection Agency’s (EPA) review of those chemicals under the Toxic Substances Control Act (TSCA). In December 2019, EPA finalized its list of 20 high-priority chemicals for risk evaluation and potential regulation under TSCA:

• Formaldehyde, a chemical commonly used in building products and as a preservative;
• Five phthalates used as plasticizers in products like plastic pipes, toys, food packaging, cosmetics and medical/dental products (BBP, DBP, DEHP, DIBP and DCHP) and one chemical used to make phthalates (phthalic anhydride);
• Three flame retardants (TBBPA, TCEP and TPP) and a chemical sometimes used in the manufacture of flame retardants and fire extinguishers (ethylene dibromide);
• A fragrance additive found in perfumes, cosmetics and other consumer products (HHCB, also known as galaxolide);
• Seven chlorinated solvents found in products like cleaning solutions, paint thinners and glues (1,1-dichloroethane, 1,2-dichloroethane, 1,2-dichloropropane, o-dichlorobenzene, p-dichlorobenzene, trans-1,2-dichloroethylene and 1,1,2-trichloroethane); and
• A chemical used to manufacture synthetic rubber (1,3-butadiene).

Additive manufacturing, more commonly known as 3D printing, has already found commercial application in various industries and its use is on the rise. 3D printing converts 3D digital models created on a computer or with a scanner into physical objects, usually by successively adding material layer by layer. The process allows manufacturers to make complex designs, rapid prototypes and final products while offering the potential to limit process waste and reduce production costs.

Safe Harbor regulations were implemented in August 2016 to require “clear and reasonable” warnings of the potential danger of exposure to consumers. Hunton Andrews Kurth partners Malcolm Weiss and Shannon Broome pick up their discussion, this time exploring aspects of the Safe Harbor regulations and the expectations for companies with products sold in California.

Under the Clean Water Act’s National Pollutant Discharge Elimination System (NPDES) and California’s Porter-Cologne Water Quality Control Act, industrial facilities in California are required to obtain coverage under the state’s NPDES general permit for discharges associated with industrial storm water activities (General Industrial Permit) or justify why they are exempt. For regulated facilities, including manufacturing facilities, landfills, mining operations, steam electric power generating facilities, hazardous waste facilities, and oil and gas facilities, failure to obtain coverage under the General Industrial Permit is a potential violation of the Clean Water Act (in addition to state law), which could expose the owner or operator of the facility to potential civil penalties of up to $54,833 per day. Enforcement, however, largely is dependent upon agency inspections or enforcement by citizen groups. Based on estimates by the California Coastkeeper Alliance, many facilities in California may have failed to enroll in the industrial storm water permit program.

California’s Proposition 65 (Prop 65), adopted in 1986 by state voters, has long been considered among the most far-reaching right-to-know and toxic chemical reduction statutes in the country. It now has competition from Washington State’s Pollution Prevention for Healthy People and Puget Sound Act (the “Act”), SSB 5135 (Chapter 292, 2019 Laws), signed into law on May 8, 2019, by former 2020 presidential candidate Governor Jay Inslee. Numerous commentators have called the Act, the nation’s “strongest” policy for regulating toxic chemicals in consumer products.

In December 2018, an article in this blog flagged a petition for EPA rulemaking under the Toxic Substances Control Act (TSCA) that, if denied, had the potential to set up precedent-setting litigation on citizens’ ability to use the courts to require EPA action under TSCA. Now, nearly a year later, the scenario that article described is coming true. In a challenge to EPA’s denial of that petition, a federal district court is poised to decide what constitutes a petition for issuance of a new rule as opposed to one for amendment of an existing rule—and in the process, to decide when a court may cast aside deference to EPA and undertake its own evaluation independent of the Agency’s record and conclusions.

California Prop 65 has allowed a slew of lawsuits to be brought by plaintiff attorneys against consumer retailers with products that end up in California.  Hunton Andrews Kurth partners Malcolm Weiss and Shannon Broome walk through the process for Prop 65 60-day notices and tactics companies can use to respond.

Going green has gone mainstream. Perhaps nowhere is this more pronounced than in the automotive industry. J.P. Morgan estimates that, by 2030, electric vehicles (EVs) and hybrids will make up 59 percent of the global market share, up from about 1 percent in 2015. What may be the most important feature of the EV revolution is its power source: lithium-ion (Li-ion) batteries. They are not new; they have been powering cell phones and computers for years. What is new is their large-scale use to power automobiles (and, some day, trucks and buses) and significantly reduce emissions. As our colleagues Samuel L. Brown and Lauren A. Bachtel note in an article to be published in the ABA’s Natural Resource & Environment magazine, components of Li-ion batteries include metals (e.g., lithium, cobalt, nickel) that are costly to extract and process. As demand for them increases, pressure to re-use or recycle batteries will increase.

Congress is exploring regulatory action for PFAS as states begin to implement their own regulations for the chemicals. Hunton Andrews Kurth attorneys, Dan Grucza and Chuck Knauss outline approaches companies can take while operating in this changing legal landscape.

California Prop 65 is designed to reduce exposures to chemicals that are known to cause cancer and reproductive harm, but it has become a flash point in California environmental law. Hunton Andrews Kurth partners Malcolm Weiss and Shannon Broome outline the regulations and the impacts on businesses with products in California.

Despite the many benefits of PFAS, there continues to be a rise in regulatory action, legal implications and environmental, health and safety concerns related to the “forever chemicals.” Hunton Andrews Kurth attorneys Dan Grucza and Chuck Knauss give an inside look into the changing regulatory landscape of PFAS.

The US Environmental Protection Agency (EPA) recently released its latest National Compliance Initiatives (NCIs), which aim to focus the Agency’s enforcement arm, the Office of Enforcement and Compliance Assurance (OECA), on areas of significant environmental violations and other opportunities for the greatest environmental benefit through increased compliance with environmental laws. In a memorandum issued June 7, 2019, enforcement chief Susan Parker Bodine advised the Agency’s regional offices of the NCIs for upcoming fiscal years 2020 through 2023.

A new decision curtails agency discretion to approve total maximum daily loads for impaired waterbodies and sets a precedent that may lead to more stringent National Pollution Discharge Elimination System (NPDES) permit limits.

Total maximum daily loads (TMDLs) have been described as “pollution budgets” for impaired waterbodies. A permitting authority developing a TMDL typically considers all known sources of the pollutant at issue (including contributions from point and non-point sources) as well as the relevant characteristics of the waterbody (such as flow rates) and determines how much pollutant the waterbody can receive without exceeding applicable water quality standards. Once a TMDL is adopted for a specific pollutant that is adversely affecting a waterbody, the permitting authority (either a delegated state or EPA) will use the TMDL to derive NPDES permit limits for facilities that are sources of the pollutant.

Guarding confidential or sensitive information is a longstanding tradition that transcends daily life. From the pinky-swearing days of childhood (to prevent your parents from finding out you rode your bike beyond their imposed boundary), to the fourth down play when your team is one point down with three seconds left on the clock, to the unique, complex chemical composition of a lifesaving drug, the concept of secrecy has roots in just about everything we do. In the business world, secrets are routinely kept to protect market share, privacy of customers, technology or for any number of other legitimate business-related concerns. Indeed, disclosure of confidential information can pose a real threat to a business’s vitality.

On Thursday, July 11, 2019, the House of Representatives approved amendments to the fiscal 2020 National Defense Authorization Act to address contamination from PFAS chemicals.

Per- and polyfluoroalkyl (PFAS) chemicals are colloquially known as “forever” chemicals due to their ability to build up and to persist over time. PFAS chemicals regulated under this bill have long been used to manufacture a wide range of products, like firefighting foam, cookware, stain repellents, apparel and food packaging and wrappers.

The EU's Approach to Product Stewardship

While the European Union (EU) does not have any legal principle specific to product stewardship, it has applied the full range of EU environmental law principles to create a comprehensive framework for product stewardship. These principles include the prevention and precautionary principles, sustainability, extended producer responsibility, supply chain responsibility, and corporate social responsibility. In addition, product stewardship is a key instrument in the EU's latest strategic environmental focus areas: the circular economy and the toxic-free environment, two main themes of current EU environmental policy making.

On March 15, 2019, the House Subcommittee on Environment and Climate Change held a hearing titled, “Protecting Americans at Risk of PFAS Contamination & Exposure.” The hearing examined approaches to eliminate or reduce environmental and health risks to workers and the public from per- and polyfluoroalkyl substances (PFAS).

In a lawsuit recently filed in the Southern District of New York, a group of environmental plaintiffs allege that, for nearly 30 years, the federal Environmental Protection Agency (EPA) has failed to develop worst-case hazardous substance discharge, or spill, regulations under Section 311(j)(5) of the Clean Water Act (CWA). This suit comes on the heels of EPA’s June 2018 proposal not to develop a general hazardous substance spill program under CWA § 311(j)(1) (a provision related to the Spill Prevention, Control and Countermeasure (SPCC) Rule well known to industrial facilities storing oil) because of the many other programs EPA believes already regulate the prevention and containment of hazardous substance spills. That proposal is expected to be finalized in August 2019 under a 2016 consent decree in which EPA agreed to evaluate the need for general rules governing the prevention and containment of hazardous substance spills. The new lawsuit narrowly focuses on worst-case hazardous substance spills and the need for corresponding facility response plans.

Everyone can agree that environmental assessments should be based on the best science. The “best” science, however, is an ever-advancing standard. Despite budget uncertainties and other hurdles, EPA scientists often pioneer new methods of assessment capable of detecting smaller and smaller increments of environmental impact. Although it may take years for EPA to develop and demonstrate a new method, stakeholders may benefit from paying attention to the development process and seeking opportunities to participate in it.

Legalization of medicinal and adult-use cannabis in California has fomented a surge of seed-to-sale companies angling to lure market share from a sea of customers. The water may soon be agitated, however, by the Office of Environmental Health Hazard Assessment (OEHHA). OEHHA is the lead California agency that oversees implementation of Proposition 65, formally known as the Safe Drinking Water and Toxic Enforcement Act of 1986. OEHHA recently announced that it has selected cannabis (marijuana), marijuana (cannabis) smoke, cannabis extracts, and delta-9-Tetrahydrocannabinol (THC) for review for possible listing under Proposition 65 as chemicals that cause reproductive toxicity. If the Developmental and Reproductive Toxicant Identification Committee (DARTIC) determines that these chemicals cause reproductive toxicity based upon “scientifically valid testing according to generally accepted principles,” marijuana in its various forms will likely join a list of more than 900 chemicals known to the state to cause cancer, birth defects, or other reproductive harm. Companies that cultivate, distribute, and/or sell marijuana and products containing marijuana in California would then be required to warn consumers—and possibly employees and passersby—that exposure to these listed chemicals can cause reproductive harm.

2018 was a banner year for M&A activity in the energy space, with numerous high dollar value transactions in the upstream, midstream, downstream and oil field services (OFS) segments. As investors in the public securities markets have shown a significantly decreased appetite for new issuances of equity by energy companies, the preferred exit or growth strategy for 2018 has been through strategic mergers, acquisitions or divestitures. These transactions have manifested themselves in various forms: asset acquisitions and divestitures, private equity investment into “drillcos” with strategic oil and gas companies, public-public mergers between OFS companies and upstream shale drillers, and simplification transactions by master limited partnerships (MLPs) in the midstream space. In addition to all this M&A activity, one element has become significantly more prevalent in the oil and gas industry throughout 2018 and shows no signs of letting down for 2019: water.

Because of their widespread environmental presence, persistence and bioaccumulation, the group of substances known as PFAS have been described as a “Perfect Storm” of liability. The number of plaintiff’s suits concerning PFAS have spiked in the last few years. Also, EPA faces increasing bipartisan calls from Congress to adopt new drinking water standards and cleanup levels. In the interim, states are filling the void. In October 2017, the New Jersey Department of Environmental Protection  announced a maximum contaminant level (MCL) of 14 parts per trillion for PFOA. Some NGO’s have called for levels as low as 1 part per trillion.

A pending petition for rulemaking under the Toxic Substances Control Act (TSCA) could represent the latest test of the scope of TSCA’s citizen petition provisions. Denial of this petition would tee up a precedent-setting court battle addressing citizens’ ability to force EPA to exercise its TSCA section 8 authority to require chemical data reporting. And while the petition on its face is focused on requiring additional information collection, it could have important implications for EPA’s implementation of TSCA’s amended provisions regarding regulation of existing chemicals under section 6.

Each year, the National Oceanic and Atmospheric Administration’s (NOAA) Climate Prediction Center puts out a forecast for the upcoming hurricane season, stressing the dangers posed by hurricanes and the need to prepare. About this time last year, Hurricane Harvey made landfall in South Texas as a Category 4 and resulted in historic flooding. The devastating aftermath of the hurricane still continues. Preparation for and responding to incidents, such as those caused by Hurricane Harvey, has become increasingly more complex and more important than ever.

Weeks after a federal judge called the science behind the alleged carcinogenicity of glyphosate “shaky,” a California state court jury hammered Monsanto with a $289 million verdict, connecting a former groundskeeper’s non-Hodgkin’s lymphoma to his exposure to the Roundup^® chemical. The August 10, 2018 verdict in Johnson v. Monsanto Co., No. CGC16550128 (California Superior Court, County of San Francisco)—which included $250 million in punitive damages—was the first in the nearly 8,000 Roundup-related cases currently pending against Monsanto, many of which are consolidated in multidistrict litigation in California federal court. However, adding another layer of confusion surrounding the use of glyphosate, a federal court in California recently decided that the state could not require Proposition 65 cancer warnings on products containing the chemical. The intense publicity surrounding the verdict has left retailers whose products contain ingredients that might have been treated with glyphosate wondering whether their products may be targeted next.  

This summer, EPA sparked public outrage with its proposed “significant new use” rule, or SNUR, addressing certain commercial uses of asbestos. Publications like Rolling Stone, Newsweek and The Daily Beast criticized EPA for loosening its regulations to pave the way for asbestos to be reintroduced to the market, allowing asbestos-containing construction materials to be used in homes and other buildings again for the first time in decades. National figures like Senator Brian Schatz and Chelsea Clinton drew attention to the proposal while condemning the Agency for increasing public exposure to this well-known carcinogen.

There’s just one issue: EPA’s proposed action does the opposite of what these critics claim. The SNUR would impose substantial new prohibitions on the listed uses of asbestos—which currently are not regulated by EPA at all—while giving EPA the necessary legal “hook” to restrict or even ban these uses outright in the unlikely event that a company actually tries to resume them.

How can news reports have gotten it so backward?

As explained in an earlier post, PFAS (per- and polyfluoroalkyl substances) are highly fluorinated manmade compounds that are reported to have a variety of adverse health effects. PFAS are resistant to heat, water and oil. These properties have led to use of PFAS compounds in a wide-range of products designed to be waterproof, stain‑resistant or non‑stick, such as carpets, furniture, cookware, clothing and food packaging. They are also used in fire retardant foam at airfields and industrial processes involving flammable and combustible liquids. PFAS compounds are resistant to chemical breakdown. This property, combined with their extensive use, explain why PFAS compounds are being found in drinking water supplies throughout the country.

What is California’s Proposition 65?

California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65) is one of the most onerous chemical right-to-know statutes in the nation. It prohibits businesses with 10 or more employees, including businesses that merely ship products into California, from exposing people in California to listed chemicals without providing a “clear and reasonable” warning.

Why Should I Care?

Bringing a Prop 65 action is relatively easy and lucrative for private plaintiffs and their counsel. In 2017, there were nearly 700 cases settled with defendants paying more than $25,000,000 in plaintiffs’ attorneys fees and penalties. This does not include defense counsel fees, business interruption and other costs to comply.

As the spotlight continues to focus on the City of Flint and its efforts in response to its public health crisis four years ago, water utilities seeking to avoid similar liability (and notoriety) should study Flint as a veritable textbook on potential liability under the federal Safe Drinking Water Act (SDWA), the US Constitution, and state law. Part 1 of this series noted that a spate of civil lawsuits and criminal charges were filed in the aftermath of Flint. These cases are still unfolding in the courts.

The Administration is considering substantial changes to the current regulatory approach to reducing exposure to lead in drinking water. The US EPA (EPA) is assessing long-term revisions to the Lead and Copper Rule (LC Rule), a Safe Drinking Water Act (SDWA) regulation that seeks to protect public health by minimizing lead and copper in drinking water, primarily through corrosion control measures. Lead contamination in drinking water has been the subject of national scrutiny in the aftermath of the public health crisis in Flint, Michigan, where high levels of lead leached from aging pipes into the city’s drinking water after the city switched its source of drinking water to the Flint River, the quality of which was more corrosive than the prior source. Congress eventually banned lead pipes in new construction with amendments to the SDWA in 1986, but in a 2016 survey, the American Water Works Association estimated that 6 million lead-containing service lines continue to distribute drinking water to 15-22 million people in the United States. As state and local governments nationwide confront similar challenges, EPA appears poised to address the legacy of lead infrastructure through updates to the LC Rule. In January 2018, EPA Administrator Scott Pruitt pledged to update the LC Rule as part of his “war on lead” in drinking water.

In a surprising decision, a federal judge last week blocked California from requiring Monsanto to put Proposition 65 warning labels on its Roundup products, ruling there is “insufficient evidence” that glyphosate—the active ingredient in the popular weed killer—causes cancer.

On February 7, 2018, US Environmental Protection Agency (EPA) Administrator Scott Pruitt signed a proposed rule to establish user fees to defray EPA’s costs of administering its responsibilities under the Toxic Substances Control Act (TSCA), as amended by the 2016 Frank Lautenberg Chemical Safety for the 21^st Century Act (Lautenberg Act). EPA estimates in the proposed rule that it will collect about $20.05 million per year in user fees, not counting any user fees associated with manufacturer-requested risk evaluations, which would range from $1.3 million to $2.6 million per evaluation.

Last October we saw the State of California implement its "PSM for Refineries" standard and now the State of Washington's Division of Occupational Safety and Health (DOSH) appears to be following suit, releasing draft language to adopt a rule of its own. This new chapter will only apply to Process Safety Management (PSM) for petrochemical refining facilities.

A New Jersey court recently held that an electrical products manufacturer was entitled to coverage rights provided by a predecessor’s commercial general liability policies if it was found liable for environmental remediation costs as a result of cleanup efforts by the US Environmental Protection Agency (EPA) along a 17-mile portion of the Passaic River in New Jersey.

New chemicals of concern, new scientific and technical developments, newly discovered wastes, or natural disasters can add up to new CERCLA liabilities. When the Comprehensive Environmental Response Compensation and Liability Act (“CERCLA”) was passed in 1980, it did not address the finality of judgments and settlements for the cleanup of contaminated sites. Some early settlements with EPA provided a complete release from all future CERCLA liability, but that later changed when the United States Environmental Protection Agency (“EPA”) began to limit the scope of covenants not to sue to specified “matters covered” by the settlement. The 1986 CERCLA amendments in section 122(f)(6), 42 U.S.C. § 9622(f)(6)(1) permanently made the change to require “reopeners” in all but a few limited circumstances.

Last year, President Obama signed into law the amended Toxic Substances Control Act (TSCA). Congress made substantial changes with respect to how both existing and new chemical substances are regulated. Some of these changes are significant and will have a direct impact on US chemical manufacturers, importers, distributors and users. However, the US did not attempt to mimic the EU’s REACH Regulation.

This article provides a high-level comparison of the main building blocks of the two regimes, bringing out the main similarities and differences between them. Of course, these are two different jurisdictions and no direct comparison can be completely valid, but it is worth making the comparison nonetheless, because many companies operate across both regions and because other jurisdictions have mimicked REACH in their regulatory reform, whereas the US has chosen not to.

Environmental and public-health groups have taken issue with the EPA’s rule establishing procedures for chemical risk evaluations under the revised Toxic Substances Control Act (TSCA), which allows the EPA to exclude certain conditions of use when assessing whether a chemical presents unreasonable risks. These groups fear the exclusions could provide a “loophole” allowing some chemical risks to go unaddressed. But putting those concerns aside, should companies affected by the rule actually want to take advantage of these exclusions? Are they really beneficial to regulated industries? Or do they risk undermining one of the primary goals that companies sought to gain by supporting TSCA reform—federal preemption of overlapping state restrictions?

Last year Congress directed the US Environmental Protection Agency (EPA) to review new chemicals by a new process. A major question for manufacturers and consumers is whether EPA can do this within a reasonable time period without unnecessarily getting in the way of innovation.

Since enactment of the Lautenberg Act amending the Toxic Substances Control Act (TSCA) in June 2016, the pace of EPA’s review of new chemicals has slowed dramatically. While EPA’s pre-enactment new chemicals program handled around 1,000 premanufacture notifications (PMNs) annually, EPA estimates that a backlog of about 600 new chemicals had built up by January 2017, which created a substantial concern in the regulated community.

In 1980, a lame duck Congress passed the nation’s first legislation, the Comprehensive Environmental Response Compensation and Liability Act, 42 U.S.C. §9601 et seq. (CERCLA), to address the cleanup of toxic waste disposal sites. Comprehensive amendments were passed six years later. Over the next 30 years, EPA’s enforcement powers were used with increasing regularity and consistency to study, begin, and often complete cleanups at hundreds of the nation’s contaminated waste sites. The program has always had its critics, but not until the current administration has there been a fundamental reassessment of its basic cost-benefit structure, just as is being done with many other federal programs.

What They Are:  PFASs (per- and polyfluoroalkyl substances) comprise a group of highly fluorinated manmade compounds that are showing up in drinking water supplies around the country. They are resistant to heat, water and oil, as well as to chemical breakdown. Because of these properties, PFASs have been used for decades as surface protection in a wide range of consumer products including carpets, clothing, cookware and food industry paper products such as pizza boxes and sandwich wrappers. PFASs are also present in foam used for fighting fires involving flammable or combustible liquids, such as oil and gasoline. Additionally, mist suppressants for metal plating operations may contain PFASs.

The fiscal year 2018 budget blueprint released by the Trump administration on March 16, 2017, proposes to zero out funding for the Chemical Safety Board (CSB or the Board). Elimination of CSB funding would reduce federal government expenditures by approximately $12 million annually.