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On May 17, 2023, the US District Court for the District of Massachusetts granted summary judgment to federal government defendants and intervenor Vineyard Wind in the first of four lawsuits pending in that court challenging the development of Vineyard Wind, a 62-turbine offshore wind project being built off the coast of Massachusetts, approximately 14 nautical miles south of Nantucket and Martha’s Vineyard at its nearest point. Vineyard Wind—which is slated to be the nation’s first commercial-scale offshore wind project, with capacity to power over 400,000 homes and businesses—has been under development for several years and has met opposition from a range of constituencies, including local residents and the fishing industry.

Continue Reading Federal Judge Rules for Vineyard Wind in First of Four Pending Actions
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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.

Proposed Prohibitions on Methylene Chloride Uses

In proposing risk management actions for methylene chloride, EPA found that several consumer, commercial, and industrial uses of the substance require regulatory action, predominantly a prohibition on use, as shown in Table 3 of the proposed rule. Many of these conditions of use include, but are not limited to, industrial and commercial use of methylene chloride in solvents for cleaning, paints and coatings (and removers), vapor degreasing, adhesives, sealants, caulks, textiles and fabrics, automotive care products, lubricants and greases, pipe insulations, oil and gas drilling, toys, playground and sporting equipment, and plastic and rubber products. EPA also identified the need for a prohibition for all consumer uses of methylene chloride that were evaluated.

EPA asserts that the requirements in this proposal would prohibit uses that account for approximately one-third of the total annual production volume of methylene chloride generated (TSCA and non-TSCA uses), “leaving a sufficient supply in circulation to provide a source for these critical or essential uses for which EPA is proposing to allow continued use” either through a critical use exemption or a WCPP.

Timeline for Risk Management Actions

Once EPA finds during risk evaluation that a substance presents an unreasonable risk of injury to human health or the environment, it is required to propose risk management requirements to the extent necessary so that the substance no longer presents such risk. In issuing risk management restrictions on a chemical, EPA must factor in considerations such as the economic consequences of the rule, including consideration of costs and benefits, cost-effectiveness, and the impact of the rule on the economy, small business, and technological innovation. EPA is also required to consider whether technically and economically feasible alternatives will be available as substitutes when banning a use of a substance.

EPA has proposed the following prohibitions on the use of methylene chloride and timelines for the prohibitions to take effect:

EPA also proposes downstream notification requirements for companies who ship methylene chloride to customers and recordkeeping requirements.

The use of methylene chloride in paint and coating removal for consumer use is not included in the listed prohibitions because this use is already addressed by an existing risk management rule promulgated by EPA in 2019, codified at 40 C.F.R. § 751.101.

Critical Use Exemptions (Time-Limited Exemptions)

Section 6(g) of TSCA allows EPA to exempt from the requirement of a risk management rule specific uses that EPA finds to be critical or essential uses for which no technically and economically feasible safer alternative is available or provide a substantial benefit as compared to reasonably available alternatives. It also allows exemption if EPA finds that compliance with the requirement would significantly disrupt the national economy, national security, or critical infrastructure. EPA proposes critical use exemptions for the following conditions of use of methylene chloride:

Ten Conditions of Use Allowed to Continue but Subject to WCPP Requirements

EPA’s proposed WCPP for allowed uses of methylene chloride includes comprehensive requirements for the protection of workers from exposures, including respiratory protection, use of PPE, exposure monitoring, training, and regulated areas. Of note, EPA proposes an Existing Chemical Exposure Limit (ECEL) for airborne concentrations of methylene chloride in excess of 2 parts per million (ppm) based on an 8-hour time weighted average (TWA), which is significantly lower than the current OSHA permissible exposure limit (PEL) for methylene chloride of 25 ppm. The proposed action level would be a value half of the ECEL that would trigger additional monitoring action to ensure workers are not exposed to concentrations above the ECEL. EPA also proposes a short-term exposure limit (EPA STEL) of 16 ppm as determined over a sampling period of 15 minutes.

EPA proposes, in lieu of prohibitions, worker protection requirements for the following conditions of use:

  1. Manufacturing (for downstream uses that would continue under WCPP)
  2. Import (for downstream uses that would continue under WCPP)
  3. Processing: As a reactant. Note that EPA is allowing this use to continue under WCPP because it believes a large volume of methylene chloride is processed for this condition of use, which almost entirely goes towards the manufacture of the hydrofluorocarbon HFC-32. HFC-32 is one of the regulated substances that are subject to a phasedown under the American Innovation and Manufacturing Act (AIM Act) of 2020. EPA expects that, by allowing for the continued, controlled use of methylene chloride in the manufacture of HFC-32, efforts to shift to chemicals with lower global warming potential would not be impeded by this rulemaking.
  4. Processing: Incorporation into a formulation, mixture, or reaction product
  5. Processing: Repackaging
  6. Processing: Recycling
  7. Industrial and commercial use as a laboratory chemical
  8. Disposal
  9. Industrial or commercial use for paint and coating removal from safety-critical, corrosion-sensitive components of aircraft and spacecraft that are owned or operated by the US DOD, NASA, DHS, and FAA that is performed by the agency or the agency’s contractor at locations controlled by the agency or the agency’s contractor
  10. Industrial or commercial use as a bonding agent for acrylic and polycarbonate in mission-critical military and space vehicle applications, including in the production of specialty batteries for applications that are performed by the DOD, NASA or DHS or their contractors at locations controlled by the agency or the agency’s contractor

Key Considerations of Proposed Rule

Stakeholders who manufacture, process, distribute, or otherwise use methylene chloride for any of the conditions of use evaluated by EPA will likely be interested in commenting on many aspects of this precedent-setting proposed rule. Stakeholders may consider providing input to EPA in the following areas:

  • Risk management approach for the conditions of use evaluated: Stakeholders may wish to evaluate whether the proposed risk management requirements proposed for each condition of use are consistent with EPA’s findings from its risk evaluation of methylene chloride for each condition of use and EPA’s statutory authority under Section 6 of TSCA. For example, if EPA found that unreasonable risk is driven by dermal exposures to methylene chloride from a particular condition of use, and if EPA requires more than dermal protection to mitigate the risks, stakeholders may wish evaluate whether such additional requirements are appropriate.
  • Costs: EPA estimates that the incremental, non-closure-related costs of this proposed rule are $13.2 million annualized over 20 years at a 3 percent discount rate and $14.5 million annualized over 20 years at a 7 percent discount rate. Stakeholders may wish to evaluate whether these projected costs appropriately include all aspects of implementation of the proposed rule, including the costs for reformulating (for banned uses) or compliance with WCPP for conditions of use permitted to continue, including compliance with the 2 ppm ECEL.
  • WCPP requirements: For conditions of use which EPA proposes to prohibit, stakeholders may evaluate whether they have data to support that compliance with a WCPP would sufficiently reduce exposures rather than a prohibition (in particular, for the conditions of use for which EPA proposes a WCPP as an alternative to a ban in the primary alternative option provided in the proposed rule). Stakeholders may also wish to evaluate the feasibility of the WCPP requirements and consider consistency with OSHA’s methylene chloride standard.
  • Timelines: Stakeholders may consider whether the proposed timelines for bans are feasible and whether other uses are appropriate for consideration for a time-limited critical use exemption based on the statutory criteria for critical use exemptions.
  • Alternatives: Stakeholders may want to comment on EPA’s alternatives assessment for methylene chloride and whether the proposed prohibited uses under the rule have available, safer alternatives to transition to.
  • De minimis level: EPA specifically requests comment regarding the number of entities that could potentially go out of business, as well as associated costs, with a prohibition on methylene chloride for certain industrial and commercial conditions of use identified in the proposed rule. EPA would also like comment on whether it should consider a de minimis level of methylene chloride in formulations for certain continuing industrial and commercial uses to account for impurities (e.g., 0.1% or 0.5%) when finalizing the prohibitions, and, if so, what level should be considered de minimis.
  • Certification and training: EPA explains in the proposal that it also examined the extent to which a certification and limited access program restricting methylene chloride use to trained and licensed users could ensure that only certain workers employed by a facility would be able to purchase and use methylene chloride. Stakeholders may wish to comment on whether a certification and training program would effectively reduce exposures to workers as a risk management approach for certain conditions of use, including conditions of use that EPA is proposing to ban.

For more information on this rulemaking, please contact Hunton’s chemicals team.

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On April 27, 2023, the Environmental Protection Agency (EPA) published a Proposed Rule to grant Louisiana primacy to administer and enforce the Class VI Underground Injection Control (UIC) program within its borders. EPA approval of Louisiana’s primacy application would authorize the Louisiana Department of Natural Resources (LDNR) to issue UIC permits for Class VI geologic carbon sequestration facilities and undertake compliance enforcement for such facilities located within the state. EPA has determined that Louisiana’s application meets the necessary requirements for approval and is soliciting public comments on the proposal. One of the major sticking points in EPA’s approval of Louisiana’s program has been the approach to incorporating environmental justice (EJ) into the Class VI permit process. LDNR has agreed to implement a number of EJ-focused elements into the permitting process, including robust EJ analysis and public participation.

Continue Reading EPA Proposes to Give Louisiana Authority for CO2 Injection Permits Under Condition that State Permit Process Includes Robust Environmental Justice Analysis and Outreach
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On April 6, 2023, President Biden issued Executive Order 14094, Modernizing Regulatory Review. This Executive Order (EO) makes several important changes to the Office of Management and Budget’s (OMB) regulatory review process for federal agency regulations. The EO significantly affects which regulations qualify for interagency review, modifies the OMB gatekeeping function by which meetings are granted on proposed rules, and requires the Office of Information and Regulatory Affairs’ (OIRA) to amend policies underlying how the federal government conducts cost-benefit analysis. In addition, OIRA has released a suite of new draft guidance documents that serve to implement the EO that, if finalized, will impact the review process for regulations. These guidance documents are open for comment as described below.

Continue Reading Biden Administration Changes White House Regulatory Review
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President Biden signed a new Executive Order (E.O.) to advance environmental justice (EJ) late last week, just in time for Earth Day. E.O. 14096, Revitalizing Our Nation’s Commitment to Environmental Justice for All, aims to carry out its title through a bevy of actions, including requiring agencies to create EJ strategic plans, directing research on EJ issues, expanding notifications for toxic chemical releases, and increasing coordination on EJ by establishing a new EJ Interagency Council and White House Office of Environmental Justice. The new E.O. builds on the Biden Administration’s “whole-of-government” approach to EJ, making clear that the obligation to consider and address EJ applies across federal agencies. The E.O.’s directives are likely to guide federal agency permitting, funding grants, and other authorizations for projects or activities that may have implications for EJ communities. On the same day as the E.O. was signed, the administration also announced a handful of other steps to further its EJ priorities.

Continue Reading New Environmental Justice Executive Order Includes Additional Requirements and Accountability Measures for Federal Agency Environmental Justice Efforts
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On March 29 the US House of Representatives adopted by voice vote an amendment offered by Reps. Dan Crenshaw (R-TX) and August Pfluger (R-TX) to speed up Environmental Protection Agency (EPA) review of state applications for primacy to run the Class VI Underground Injection Control (UIC) program. The amendment was included in H.R. 1, the Lower Energy Costs Act, the high-profile energy and permitting reform bill the House approved on March 30.

The UIC program is designed to prevent endangerment of underground sources of drinking water from subsurface injections. The Class VI program specifically regulates the geologic sequestration of carbon dioxide, which is considered to be essential for the world to meet international emission reduction targets. 

Continue Reading House of Representatives Approves Class VI Primacy Amendment
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President Biden issued his second veto late last week. The President’s second veto protects a U.S. EPA rule that went into effect on March 20, 2023. That rule redefines “waters of the United States” (WOTUS), and at a high conceptual level, returns the Agency’s interpretation of WOTUS to that of the Obama administration, an interpretation that was revoked and replaced by the Trump administration.

This matter has been hotly contested in the federal courts. Indeed, the U.S. Supreme Court is poised to issue a ruling within the next several weeks on Sackett v. EPA, a decision which could substantially revise and narrow the Agency’s definition of “waters of the United States.” The Court’s decision here could send the Biden administration’s revised definition of WOTUS back to EPA for changes needed in-line with the Court’s decision, if and when issued.

Continue Reading President Biden’s Second Veto Is on Congress’ Disapproval of EPA’s Revised Definition of WOTUS
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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.

Continue Reading EPA Proposes National Primary Drinking Water Regulation to Set Stringent Limits on PFAS in Drinking Water, Including Four Newly Targeted Substances
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On March 21, 2023, the US Department of Energy (DOE) released a series of reports aimed at advancing President Biden’s ambitious goal of achieving  a decarbonized electricity sector by 2035 and net-zero emissions economy-wide by 2050. (See Executive Order 14057, Catalyzing Clean Energy Industries and Jobs Through Federal Sustainability, Dec. 8, 2021.) The reports come on the heels of the Intergovernmental Panel on Climate Change’s March 20, 2023, Synthesis Report for the Sixth Assessment Report, calling for urgent action on climate change. 

Continue Reading DOE Identifies Pathways for the Large-Scale Commercialization of Clean Energy Technologies
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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.

Continue Reading EPA Proposes A Cumulative Risk Approach for Chemical Risk Assessment under TSCA