Tag: Environmental Protection Agency

President Biden’s FY 2024 Budget Includes Additional Funding for TSCA and Funding to Address PFAS Pollution

On March 9, 2023, President Biden released his fiscal year (FY) 2024 budget. According to the U.S. Environmental Protection Agency’s (EPA) March 9, 2023, press release, the budget requests over $12 billion in discretionary budget authority for EPA in FY 2024, a $1.9 billion or 19 percent increase from the FY 2023 enacted level. Highlights of the FY 2024 budget include:

  • Ensuring Safety of Chemicals for People and the Environment: The budget provides an investment of $130 million, $49 million more than the 2023 enacted level, to build core capacity to implement the Toxic Substances Control Act (TSCA). Under TSCA, EPA has a responsibility to ensure the safety of chemicals in or entering commerce. According to EPA, in FY 2024, it “will focus on evaluating, assessing, and managing risks from exposure to new and existing industrial chemicals to advance human health protection in our communities.” EPA states that “[a]nother priority is to implement [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] to ensure pesticides pose no unreasonable risks to human health and the environment.”
  • Tackling Per- and Polyfluoroalkyl Substances (PFAS) Pollution: The budget provides approximately $170 million to combat PFAS pollution. This request allows EPA to continue working toward commitments made under EPA’s 2021 PFAS Strategic Roadmap, including: increasing its knowledge of PFAS impacts on human health and ecological effects; restricting use to prevent PFAS from entering the air, land, and water; and remediating PFAS that have been released into the environment.

EPA states that it will release the full Congressional Justification and Budget in Brief materials “soon.”

Article By Lynn L. Bergeson and Carla N. Hutton of Bergeson & Campbell, P.C.

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©2023 Bergeson & Campbell, P.C.

EPA and Army Corps Issue New “WOTUS” Rule While Supreme Court Considers Jurisdiction Over Adjacent Wetlands

Yesterday, the US Environmental Protection Agency (EPA) and the US Army Corps of Engineers (Corps) (together, the Agencies) published a final rule revising the definition of “waters of the United States” (WOTUS) subject to federal regulation and permitting requirements under the Clean Water Act (CWA).  This rule is the latest attempt by the Agencies to craft a durable rule defining WOTUS.  The new rule, which largely mirrors the 2021 proposal, asserts a broader geographic scope of federal jurisdiction than the 2020 Navigable Waters Protection Rule (NWPR).  In particular, the Agencies adopt the broadest possible interpretation of the Supreme Court’s decision in Rapanos (through incorporation of both the plurality’s “relatively permanent” test and Justice Kennedy’s “significant nexus” test).  The final rule would, for the first time, codify aspects of the Agencies’ 2008 Rapanos Guidance and would rely on the significant nexus test’s case-by-case approach for evaluating jurisdiction for tributaries, wetlands, and other waters.  The Agencies released the final rule while the Supreme Court considers the scope of CWA authority over a major category of WOTUS, “adjacent wetlands,” in Sackett v. EPA, and the Supreme Court could hand down a decision in the coming months that could require changes to the rule.

For project proponents, the new rule would likely mean more features would be subject to regulation under the CWA, and projects that might have previously qualified for nationwide permits may no longer meet the acreage limits and would instead require an individual permit.  Also, case-by-case significant nexus determinations could result in lengthy reviews with uncertain and inconsistent results.

The final rule will go into effect on March 20.  While the Agencies previously characterized this rule as Phase 1 of a two-step process to enact a new WOTUS definition, EPA recently indicated that it is not currently planning a major second phase.

Summary of Final Rule

The rule defines WOTUS to include:

  1. Traditional navigable waters (TNWs), the territorial seas, and interstate waters.  TNWs include large rivers and lakes and tidally influenced waterbodies used in interstate or foreign commerce.  Interstate waters are rivers, lakes, and other waters that flow across, or form part of, State boundaries.  The TNW definition (i.e., all waters currently used, or were used in the past, or may be susceptible to use in interstate or foreign commerce, including all waters which are subject to the ebb and flow of the tide) is consistent with the text of the 1986 regulations and the NWPR.  However, the preamble indicates that the Agencies plan to include “waters currently being used for … commercial waterborne recreation (for example, boat rentals, guided fishing trips, or water ski tournaments),” which appears to broaden the scope of TNW waters.
  2. Impoundments of WOTUS.  The final rule retains the provision in the 1986 regulations that defines WOTUS to include impoundments of WOTUS.  The preamble defines impoundments as “created by discrete structures (often human-built) like dams or levees that typically have the effect of raising the water surface elevation, creating or expanding the area of open water, or both.”  88 Fed. Reg. at 3,066.
  3. Tributaries.  The final rule extends jurisdiction to tributaries of categories 1 and 2 waters if the tributary meets either the Agencies’ new formulation of the relatively permanent or the significant nexus standards from Rapanos (discussed in more detail below).  Ephemeral streams that meet the significant nexus test would be jurisdictional tributaries.  In this respect, the rule is much broader than the NWPR, which categorically excluded ephemeral tributaries from jurisdiction.
  4. Adjacent wetlands.  The rule retains the definition of “adjacent” from the 1986 regulations meaning “bordering, contiguous, or neighboring” and adds language that adjacent wetlands are considered WOTUSifthey meet the relatively permanent or significant nexus standards.  The NWPR had narrowed the definition of adjacent wetlands to include only those wetlands that abutted or otherwise had a direct surface connection to other jurisdictional waters in a typical year.  The final rule creates a broader category of adjacent wetlands, leading to additional regulatory requirements for activities that cross or impact such features.
  5. Other waters.  The rule asserts jurisdiction over “other waters” under the relatively permanent and significant nexus standards from Rapanos.  Under this provision, which essentially serves as a “catch-all” category, “intrastate lakes and ponds, streams, or wetlands” not identified in categories 1-4 can be assessed for jurisdiction under the relatively permanent standard or significant nexus standard.  This list is intended to be exclusive, 88 Fed. Reg. at 3,100, but broad enough to include a large variety of water types (e.g., prairie potholes, sloughs, playa lakes, etc.).  This category is a clear departure from the 2008 Rapanos Guidance, which did not assert jurisdiction over “other waters” based on the relatively permanent waters or significant nexus standards.

Exclusions.  The final rule provides a list of features that are excluded even where they would otherwise qualify as jurisdictional impoundments, tributaries, adjacent wetlands, or other waters.  Importantly, features that qualify as category 1 waters (TNWs, territorial seas, and interstate waters) cannot be excluded even if they meet the criteria of the exclusions provided.  Key non-jurisdictional waters or exclusions include waste treatment systems, ditches, prior converted cropland, artificially irrigated areas, artificial lakes or ponds, and swales and erosional features.  The list of exclusions is similar to the list provided in the 2015 WOTUS Rule and 2020 NWPR, although it does not provide the clear definitions that were included in the NWPR and in some instances changes the exemption based on preamble interpretations.

Key Definitions. The rule also includes a number of important definitions.

  • The “relatively permanent standard” asserts jurisdiction over relatively permanent, standing or continuously flowing waters connected to category 1 waters, and waters with a continuous surface connection to such relatively permanent waters or to category 1 waters.  88 Fed. Reg. at 3,006.  The final rule does not define or quantify what constitutes “relatively permanent” flow.  The preamble states that the relatively permanent standard encompasses surface waters that have flowing or standing water year-round or continuously during certain times of the year.  88 Fed. Reg. at 3,084.
  • The significant nexus standard asserts jurisdiction over waters that, either alone or in combination with similarly situated waters in the region, significantly affectthe chemical, physical, or biological integrity of category 1 waters.  In a change from the proposal, the final rule defines “significantly affect” to mean “a material influence on the chemical, physical, or biological integrity of [category 1] waters.”  To determine whether waters, either alone or in combination with similarly situated waters in the region, have a material influence on the chemical, physical, or biological integrity of category 1 waters, the Agencies will assess the  list of functions and factors, including, for example contribution of flow, distance from a category 1 water, and hydrologic connections.  The preamble states distance from a category 1 water and hydrology—will generally be given the greatest weight in the assessment.  88 Fed. Reg. at 3,120.  The new significant nexus standard will likely allow for broader assertions of jurisdiction because it allows the Agencies to aggregate all tributaries and adjacent wetlands within a particular geographic area and evaluate whether they have a “material influence” on category 1 waters based on a case-by-case application of the enumerated factors and functions.  This type of case-by-case significant nexus analysis has resulted in lengthy review times as well as unpredictable and inconsistent results.

Existing Jurisdictional Determinations

Landowners may obtain a jurisdictional determination in the form of either: (1) an approved jurisdictional determination (AJD), which is a Corps document identifying the limits of WOTUS on a parcel; or (2) a preliminary jurisdictional determination (PJD), which is a non-binding document in which an applicant can assume all waters will be treated as jurisdictional without making a formal determination.

The Agencies take the position that AJDs issued pursuant to the NWPR may not be relied upon in making new permit decisions.  According to the preamble, because the NWPR was vacated by two district courts, NWPR AJDs “may not reliably state the presence, absence, or limits of [WOTUS] on a parcel and will not be relied upon by the Corps in making new permit decisions.”  88 Fed. Reg. at 3,136.  The Agencies take the position that AJDs issued under earlier WOTUS definitions—except those AJDs issued under the NWPR—remain valid until the AJD’s expiration date.  Also, the new rule will govern any pending requests for AJDs, if the AJD is issued on or after the effective date of the rule (March 20, 2023).

In contrast to AJDs, PJDs are advisory in nature and have no expiration date.  The preamble clarifies that the new WOTUS rule has no impact on existing PJDs.

Potential Litigation and the Sackett Case

Multiple challenges to the new rule are likely to be filed in district courts across the country.  The state of Texas and an industry coalition immediately filed suits in the U.S. District Court for the Southern District of Texas, and other suits are likely.  At the same time, the Supreme Court’s pending decision in Sackett may have implications for the durability of provisions of the rule.

Many commenters recommended that the Agencies defer issuing a final rule until the Supreme Court issues a decision in Sackett—a case in which the issue before the Court is “the proper test for determining whether wetlands are [WOTUS] under the [CWA].”  A decision in the Sackett case is expected in the next few months.  Perhaps trying to insulate the rule from a potentially unfavorable Supreme Court decision, the Agencies assert in the preamble the severability of the individual provisions of the rule.  The preamble states, “if a court were to determine that a wetland cannot be treated as adjacent if it is separated from a jurisdictional water by road or other barrier, the agencies intend that other categories of wetlands within the rule’s definition of ‘adjacent’ would remain subject to jurisdiction.”  88 Fed. Reg. at 3,135.  Although it is not clear how the Supreme Court will rule in Sackett, it is possible that the decision could require the Agencies to make changes to the new WOTUS definition or face legal challenges.

Article By Kerry L. McGrath, Brian R. Levey, Andrew J. Turner, Karma B. Brown, Deidre G. Duncan, and Matthew Z. Leopold of Hunton Andrews Kurth

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Copyright © 2023, Hunton Andrews Kurth LLP. All Rights Reserved.

EPA Announces the Release of Its Endangered Species Act Workplan Update

On November 16, 2022, the U.S. Environmental Protection Agency (EPA) announced it released an Endangered Species Act (ESA) Workplan Update (Workplan Update) that outlines major steps to increase protections for wildlife and regulatory certainty for pesticide users. The Workplan Update details how EPA will pursue protections for nontarget species, including federally listed endangered and threatened (i.e., listed) species, earlier in the process for pesticide registration review and other Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) actions. According to EPA, these early protections will help EPA comply with the ESA, thus reducing its legal vulnerability, providing farmers with more predictable access to pesticides, and simplifying the ESA-FIFRA process that, left unchanged, creates both significant litigation risk and a workload far exceeding what EPA has the resources to handle.

EPA states this update is a follow-up to EPA’s April 2022 ESA Workplan that addresses the complexity of meeting its ESA obligations for thousands of FIFRA actions annually. The ESA Workplan prioritizes certain FIFRA actions for ESA compliance, outlines how EPA will pursue early mitigation for listed species under FIFRA, and describes directions for expediting and simplifying the current pesticide consultation process.

As part of registering new pesticides or reevaluating pesticides during registration review, EPA has a responsibility under the ESA to ensure certain pesticide registrations do not jeopardize the continued existence of listed species or adversely modify their designated critical habitats. EPA states that it has seen in the past few decades an increase in litigation due to EPA’s failure to meet its ESA obligations when taking FIFRA actions. Over the next six years, existing court-enforceable deadlines will require EPA to complete ESA reviews for 18 pesticides — the most EPA estimates it can handle during this period based on its current capacity and processes. Ongoing litigation and settlement discussions for other lawsuits cover dozens of additional pesticides and will likely fill the EPA’s ESA workload well beyond 2030. According to EPA, if its ESA efforts continue at this pace, a future court may decide to curtail drastically pesticide use until EPA meets its obligations. EPA believes this situation would be unsustainable and legally tenuous and provide inadequate protection for listed species and create regulatory uncertainty for farmers and other pesticide users.

The Workplan Update is EPA’s first update to the ESA Workplan and covers four main goals:

  1. Describes EPA’s overall approach to mitigating ecological risks in registration review, which includes prioritization of registration review cases based on opportunities to reduce a pesticide’s risk to human health or the environment.

  2. Proposes a menu of FIFRA Interim Ecological Mitigation measures that EPA will draw from for many future conventional and biological pesticide registration and registration review actions to protect nontarget species. For each FIFRA action, EPA will consider this menu and propose, based on the risks and benefits of the particular pesticide, which specific measures to include on the pesticide label.

  3. Proposes label language to expand the use of online endangered species protection bulletins to implement geographically specific mitigation measures for individual listed species. These measures are designed to focus protections only in specific needed areas, thus minimizing impacts to agriculture. Where needed, EPA may develop these measures to complement the generic FIFRA ecological mitigation described above.

  4. Describes current and future programmatic initiatives with other federal agencies to prioritize mitigation for listed species that are particularly vulnerable to pesticides and to improve the efficiency and timeliness of the ESA-FIFRA process.

The first strategy described in EPA’s ESA Workplan is to “meet ESA obligations for FIFRA actions.” EPA states as part of its work to execute this strategy, it has identified a menu of Interim Ecological Mitigation measures it will use as a starting point to address pesticide risks to nontarget species during registration and registration review.

The menu of Interim Ecological Mitigation will include measures to reduce pesticide spray drift and pesticide runoff and will be considered as part of EPA’s upcoming proposed interim registration review decisions. While EPA intends for this set of Interim Ecological Mitigation measures to apply widely to many pesticides, EPA will consider the menu of options for any given pesticide depending on the level of risk that it poses to species and the exposure route.

EPA anticipates that this approach will more efficiently establish protections for nontarget species, including listed species, and standardize the protections across similar pesticides, in contrast to identifying mitigation measures pesticide by pesticide or species by species, as EPA has typically done in the past.

EPA states it will also work with registrants to add language on pesticide incident reporting, advisory language to protect insect pollinators, and language to most outdoor-use pesticide labels that directs users to reference Bulletins Live! Two, a website where pesticide users can find endangered species protection bulletins. These bulletins describe geographically specific use limitations to protect threatened and endangered species and their designated critical habitat.

EPA expects that once consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service is completed for any given outdoor-use pesticide, endangered species protection bulletins may be necessary for at least one listed species.

EPA also expects that working with registrants proactively to add the reference to Bulletins Live! Two to pesticide labels in advance of consultation will ultimately save EPA, state partners, and registrants time and resources by minimizing the number of amendments to labels.

The ESA Workplan Update also describes initiatives that, according to EPA, will help it and other federal agencies improve approaches to mitigation under the ESA and improve the interagency consultation process outlined in the ESA Workplan. These initiatives include EPA’s work to identify ESA mitigation measures for pilot species, incorporate early ESA mitigation measures for groups of pesticides (e.g., herbicides), and develop region-specific ESA mitigations.

Comments on the proposed set of interim mitigation measures and the proposed revisions to label language included in the Workplan Update appendix are due on or before January 30, 2023. Comments can be submitted at EPA-HQ-OPP-2022-0908.

Commentary

This next phase of the ESA Workplan provides more detail about how EPA plans to impose various mitigation measures to meet its ESA obligations when registering a pesticide. The most favorable view of what EPA has presented is that it continues the march toward ESA compliance, which is long overdue, and provides more detail about the kinds of mitigation approaches it will place on pesticide labels to meet ESA requirements. The less favorable view here is that EPA has outlined a number of “off the shelf” mitigation options (buffers to reduce pesticide drift and water runoff), and EPA might impose such conditions in many instances where more careful analysis of usage data and site- or use-specific considerations might lessen the areas where such mitigation measures are needed.

EPA has stated previously as part of its earlier Workplan document, issued in April 2022, that using the present approaches EPA would complete only 5 percent of the ESA required reviews in about 18 years — implying that the current approach would take about 360 years to complete. This next iteration of the Workplan, describing “early mitigation” strategies, is designed to reduce this unacceptable timeframe (360 years), but is likely to lead to fears among some stakeholders that in a “rush” to complete this work, EPA will make overly conservative label restrictions and reduce availability of the pesticide without increased species protections. Such concerns raise immediate ancillary concerns about stakeholder involvement in decision-making, compliance with what might be complicated label requirements, and enforcement of what is already typically a long list of label requirements for many current products. An example of such issues: one mitigation option example discussed is “do not use when rain is expected in the next 48 hours” — which could raise issues concerning what or how compliance might be proven or enforced.

Again, to be sure, this next document about how EPA plans to make significant progress in meeting its ESA obligations continues the effort to convince courts that it is meeting its ESA obligations. As such, it represents a large step forward where in the past EPA was left with little progress or plans to present in court as part of litigation over ESA compliance. As it continues to reveal its plans and options, however, stakeholders will need to follow closely and consider the possible impacts of the Workplan and the resulting label proposals to follow.

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©2022 Bergeson & Campbell, P.C.

EPA Updates Safer Chemical Ingredients List, Adding 22 Chemicals and Changing the Status of One Chemical

The U.S. Environmental Protection Agency (EPA) announced on August 11, 2022, that it updated the Safer Chemical Ingredients List (SCIL), “a living list of chemicals by functional-use class that EPA’s Safer Choice program has evaluated and determined meet the Safer Choice Standard.” EPA added 22 chemicals to the SCIL. EPA states that to expand the number of chemicals and functional-use categories on the SCIL, it encourages manufacturers to submit their safer chemicals for review and listing on the SCIL. In support of the Biden Administration’s goals, the addition of chemicals to the SCIL “incentivizes further innovation in safer chemistry, which can promote environmental justice, bolster resilience to the impacts of climate change, and improve water quality.” According to EPA, chemicals on the SCIL “are among the safest for their functional use.”

EPA also changed the status for one chemical on the SCIL and will remove the chemical from the list in one year “because of a growing understanding of the potential health and environmental effects.” According to EPA, the chemical was originally listed on the SCIL based on data from a closely related substance that EPA marked with a grey square earlier this year. EPA’s process for removing a chemical from the SCIL is first to mark the chemical with a grey square on the SCIL web page to provide notice to chemical and product manufacturers that the chemical may no longer be acceptable for use in Safer Choice-certified products. A grey square notation on the SCIL means that the chemical may not be allowed for use in products that are candidates for the Safer Choice label, and any current Safer Choice-certified products that contain this chemical must be reformulated unless relevant health and safety data are provided to justify continuing to list the chemical on the SCIL. EPA states that the data required are determined on a case-by-case basis. In general, data useful for making such a determination provide evidence of low concern for human health and environmental impacts. Unless information provided to EPA adequately justifies continued listing, EPA then removes the chemical from the SCIL 12 months after the grey square designation.

According to EPA, after this update is made, there will be 1,055 chemicals listed on the SCIL. EPA is committed to updating the SCIL with safer chemicals on a regular basis. EPA states that the SCIL is a resource that can help many different stakeholders:

  • Product manufacturers use the SCIL to help make high-functioning products that contain safer ingredients;
  • Chemical manufacturers use the SCIL to promote the safer chemicals they manufacture;
  • Retailers use the SCIL to help shape their sustainability programs; and
  • Environmental and health advocates use the SCIL to support their work with industry to encourage the use of the safest possible chemistry.

EPA’s Safer Choice program certifies products containing ingredients that have met the program’s rigorous human health and environmental safety criteria. The Safer Choice program allows companies to use its label on products that meet the Safer Choice Standard. The EPA website contains a complete list of Safer Choice-certified products.

Article By Lynn L. Bergeson and Carla N. Hutton of Bergeson & Campbell, P.C.

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©2022 Bergeson & Campbell, P.C.

PFAS Health Advisories Under Legal Attack…Again

On June 15, 2022, the EPA issued Health Advisories (HAs) for five specific PFAS, including PFOA and PFOS. On July 29, 2022, the American Chemistry Council filed a petition in the Court of Appeals for the District of Columbia challenging the validity of the EPA’s PFOA and PFOS HAs. The group alleges that the EPA did not follow proper procedure in setting the HAs and that the EPA’s determinations were scientifically flawed. The petition follows closely on the heels of a similar challenge to the EPA’s HA for GenX PFAS. Industries that will be impacted by upcoming EPA PFAS regulations will closely follow the petition as it makes its way through court, as it may provide predictive indicators of arguments that will unfold as the EPA’s PFAS regulations increase.

PFAS Health Advisories

In October 2021, the EPA released its PFAS Roadmap, which stated explicit goals and deadlines for over twenty action items specific to PFAS. As part of the Roadmap, the EPA pledged to re-assess the existing Health Advisories (HAs) for PFOA and PFOS, as well as establish HAs for PFBS and GenX chemicals. In June 2022, the EPA fulfilled its promise on all fronts when it set HAs for PFOA (interim), PFOS (interim), PFBS (final) and GenX (final). While not enforceable levels for PFAS in drinking water, the EPA’s PFAS Health Advisories are nevertheless incredibly significant for a variety of reasons, including influence on future federal and state drinking water limits, as well as potential impacts on future PFAS litigation.

The levels set by the EPA’s PFAS Health Advisories were as follows:

PFOA

.004 ppt

PFOS

.02 ppt

GenX

10 ppt

PFBS

2,000 ppt

Legal Challenge To PFAS Health Advisories

On July 13, 2022, The Chemours Company filed a petition challenging the validity of the EPA’s GenX HA. On July 29, 2022, the American Chemistry Council (ACC) followed suit and petitioned to have the EPA’s HAs for PFOA and PFOS vacated. In the petition, the ACC argues that the EPA circumvented procedural requirements in the Safe Drinking Water Act by setting interim HAs for PFOA and PFOS and that the EPA is improperly attempting to create enforcement standards for drinking water that are unattainable. While the HAs themselves are not enforceable, the ACC argues that the HAs are relied upon by states when they set their own drinking water standards and signal an EPA intent to set unachievably low levels of enforceable PFAS standards at the federal level. The ACC points to recent findings by the Science Advisory Board (SAB) that criticized the EPA’s reliance on the same studies and scientific articles upon which the HAs were based.

Conclusion

Now more than ever, the EPA is clearly on a path to regulate PFAS contamination in the country’s water, land and air. The EPA has also for the first time publicly stated when they expect such regulations to be enacted. These regulations will require states to act, as well (and some states may still enact stronger regulations than the EPA). Both the federal and the state level regulations will impact businesses and industries of many kinds, even if their contribution to drinking water contamination issues may seem on the surface to be de minimus. In states that already have PFAS drinking water standards enacted, businesses and property owners have already seen local environmental agencies scrutinize possible sources of PFAS pollution much more closely than ever before, which has resulted in unexpected costs. Beyond drinking water, though, the EPA PFAS Roadmap shows the EPA’s desire to take regulatory action well beyond just drinking water, and companies absolutely must begin preparing now for regulatory actions that will have significant financial impacts down the road.

Article By John Gardella of CMBG3 Law

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©2022 CMBG3 Law, LLC. All rights reserved.

EPA Will Propose to Ban Ongoing Uses of Asbestos

The U.S. Environmental Protection (EPA) announced on April 5, 2022, that it will propose to prohibit ongoing uses of chrysotile asbestos, the only known form of asbestos currently imported into the United States. EPA notes that the proposed rule will be “the first-ever risk management rule issued under the new process for evaluating and addressing the safety of existing chemicals under the Toxic Substances Control Act (TSCA) that was enacted in 2016.” EPA will propose to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos for all ongoing uses of chrysotile asbestos. EPA will also propose targeted disposal and recordkeeping requirements in line with industry standards, Occupational Safety and Health Administration (OSHA) requirements, and the Asbestos National Emission Standards for Hazardous Air Pollutants (NESHAP). EPA has posted a pre-publication version of the proposed rule. Publication of the proposed rule in the Federal Register will begin a 60-day comment period.

Background

As reported in our January 4, 2021, memorandum, EPA released on December 30, 2020, the final risk evaluation for asbestos, part 1: chrysotile asbestos (Asbestos RE Part 1). Of the six use categories evaluated (chlor-alkali diaphragms, sheet gaskets, other gaskets, oilfield brake blocks, aftermarket automotive brakes/linings, and other vehicle friction products), EPA found that there is unreasonable risk to workers, occupational non-users (ONU), consumers, and/or bystanders within each of the six chrysotile asbestos use categories. EPA found no unreasonable risk to the environment. According to the final risk evaluation, chrysotile is the prevailing form of asbestos currently mined worldwide, and “so it is assumed that a majority of commercially available products fabricated overseas that contain asbestos are made with chrysotile. Any asbestos being imported into the U.S. in articles is believed to be chrysotile.” The other five forms of asbestos are now subject to a significant new use rule (SNUR), as reported in our April 18, 2019, memorandum, “EPA Announces Final SNUR for Asbestos Will ‘Close Loophole and Protect Consumers.’”

Proposed Rule

EPA will propose a rule under TSCA Section 6(a) to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos in bulk or as part of chrysotile asbestos diaphragms used in the chlor-alkali industry and chrysotile asbestos-containing sheet gaskets used in chemical production. EPA will propose that these prohibitions take effect two years after the effective date of the final rule.

EPA will also propose pursuant to TSCA Section 6(a) to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos-containing brake blocks used in the oil industry, aftermarket automotive chrysotile asbestos-containing brakes/linings, other chrysotile asbestos-containing vehicle friction products (not including the National Aeronautics and Space Administration (NASA) Super Guppy Turbine aircraft use), and other chrysotile asbestos-containing gaskets. EPA will propose that these prohibitions take effect 180 days after the effective date of the final rule.

EPA will further propose pursuant to TSCA Section 6(a) to prohibit manufacture (including import), processing, and distribution in commerce of: aftermarket automotive chrysotile asbestos-containing brakes/linings for consumer use, and commercial use of other chrysotile asbestos-containing gaskets for consumer use. EPA will propose that these prohibitions take effect 180 days after the effective date of the final rule.

EPA will also propose disposal and recordkeeping requirements under which regulated parties would document compliance with certain proposed prohibitions. EPA states that it does not intend the proposed prohibitions on processing or distribution in commerce to prohibit any processing or distribution in commerce incidental to disposal of the chrysotile asbestos waste in accordance with the proposed requirements.

According to EPA, because a determination has been made that chrysotile asbestos presents an unreasonable risk to health within the United States or to the environment of the United States, pursuant to TSCA Section 12(a)(2), the proposed rule would apply to chrysotile asbestos even if being manufactured, processed, or distributed in commerce solely for export from the United States.

Commentary

Bergeson & Campbell, P.C. (B&C®) commends EPA on this historical achievement. Unsurprisingly, there are aspects of this precedent-setting proposed rule that invite discussion and warrant comment from affected parties. Key among these issues is a potential significant legal vulnerability in the underlying risk evaluation (i.e., Asbestos RE Part 1) for the proposed rule, an issue that may overshadow this historic achievement in a manner reminiscent of EPA’s failed ban of asbestos in 1991 (Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir., 1991)).

EPA proposed that the prohibition on specific conditions of use (e.g., chrysotile asbestos diaphragms used in the chlor-alkali industry) would take effect two years after the effective date of the final rule. EPA stated that it “believes an aggressive transition away from chrysotile asbestos will spur adoption of superior technology [e.g., membrane cells with increased concentrations of per- and polyfluoroalkyl substances (PFAS)].” The clear need to consider EPA’s intended action on asbestos in the context of its ongoing actions on PFAS is of course not lost on the Agency. EPA acknowledged that “the transition away from asbestos-containing diaphragms could result in greater usage and release of PFAS.”

B&C notes that innovative new technologies, such as alternative membrane cells, may be available in the future, but those technologies must be proven to be economically and technically viable. Once proven effective, the underlying chemical substances must be reviewed as new chemicals if so classified under TSCA. The development, review, and approval are all on indeterminate timelines, so it is speculative when novel, non-PFAS-based technologies will be commercially available and, of course, whether that time will be prior to the effective date of EPA’s proposed ban on asbestos.

EPA requested comment on specific aspects of the proposed rule that B&C encourages potentially impacted parties to consider. For example, EPA discussed its authority under TSCA Section 6(g) to grant a time-limited exemption for a specific condition of use, such as the chlor-alkali industry, where EPA finds “that compliance with the proposed requirement would significantly disrupt the national economy, national security, or critical infrastructure.”

EPA also requested comment on a primary alternative regulatory option that EPA discussed for the chlor-alkali diaphragm and sheet gasket categories that would allow a prohibition to take effect five years after the effective date of the final rule. As part of this option, EPA would include establishment of a risk-based performance standard known as an existing chemical exposure limit (ECEL). EPA developed an eight-hour time-weighted average (8-hr TWA) ECEL of 0.005 fibers/cubic centimeter (f/cc) for inhalation exposures to chrysotile asbestos as an eight-hr TWA ECEL-action level of 0.0025 f/cc, with associated requirements for initial and periodic monitoring and respirator usage/type if exceedances are found.

As part of the monitoring requirements, EPA stated that it would “require use of appropriate sampling and analytical methods to determine asbestos exposure, including: … Compliance with the Good Laboratory Practice Standards at 40 CFR Part 792,” despite the fact that EPA acknowledges that other standards, such as Industrial Hygiene Laboratory Accreditation Program (IHLAP), are more appropriate for industrial hygiene monitoring. EPA’s TSCA Section 5(e) order template states the following under Section III.D:

Compliance with TSCA GLPS, however, is not required under this New Chemical Exposure Limit Section where the analytical method is verified by a laboratory accredited by either: the American Industrial Hygiene Association (“AIHA”) Industrial Hygiene Laboratory Accreditation Program (“IHLAP”) or another comparable program approved in advance in writing by EPA.

EPA devoted one paragraph in the proposed rule to “TSCA section 26(h) considerations.” EPA stated, in part, that its unreasonable risk determination “was based on a risk evaluation, which was subject to peer review and public comment, was developed in a manner consistent with the best available science and based on the weight of the scientific evidence as required by TSCA sections 26(h) [and 26(i)] and 40 CFR 702.43 and 702.45.”

B&C notes that EPA stated in the Asbestos RE Part 1 the following:

TSCA § 26(h) and (i) require EPA, when conducting Risk Evaluations, to use scientific information, technical procedures, measures, methods, protocols, methodologies and models consistent with the best available science and base its decisions on the weight of the scientific evidence. To meet these TSCA § 26 science standards, EPA used the TSCA systematic review process described in the [2018] Application of Systematic Review in TSCA Risk Evaluations document [citation omitted] [2018 SR Document].

Prior to completing Asbestos RE Part 1, EPA requested the National Academies of Science, Engineering, and Medicine (NASEM) to review the 2018 SR Document. In February 2021, NASEM released its consensus study report on EPA’s 2018 SR Document and concluded that it did not meet the criteria of “comprehensive, workable, objective, and transparent” and that “The OPPT approach to systematic review does not adequately meet the state-of-practice.”

NASEM recommended that “With regard to hazard assessment for human and ecological receptors, OPPT should step back from the approach that it has taken and consider components of the OHAT, IRIS, and Navigation Guide methods that could be incorporated directly and specifically into hazard assessment.”

In response to the NASEM review, EPA revised its systematic review method. On December 20, 2021, EPA released the “Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances” (2021 Draft Protocol) for public comment. EPA acknowledged in the 2021 Draft Protocol that:

Previously [in the 2018 SR Document], EPA did not have a complete clear and documented TSCA systematic review (SR) Protocol. EPA is addressing this lack of a priori protocol by releasing [the 2021 Draft Protocol].

EPA further stated that the:

[2021 Draft Protocol] is significantly different [from the 2018 SR Document] in that it includes descrition [sic] of the Evidence Integration process…, which was not previously included in the [2018 SR Document].

B&C recognizes that the scientific methods used to inform systematic review are not static and that updates will be required as the science evolves. In this instance, however, many of the documents cited as supporting information for updating the 2021 Draft Protocol (e.g., Office of Health Assessment and Translation (OHAT), 2015) were available prior to EPA issuing the 2018 SR Document. Rather than utilizing these documents at the time, EPA developed the 2018 SR Document de novo. In other words, EPA chose to develop its own methodology in 2018 rather than incorporating and adapting existing methodologies that represented the best available science at the time.

These issues raise interesting procedural questions and issues around whether EPA demonstrated that Asbestos RE Part 1 was based on the best available science and weight of scientific evidence, as required under TSCA Sections 26(h) and 26(i) and the implementing regulation under 40 C.F.R. Part 702.

B&C encourages stakeholders to review EPA’s proposed risk management rule on chrysotile asbestos, even for entities that do not manufacture, process, distribute, or use this substance. We urge this review because of the precedential nature of EPA’s decisions. B&C also encourages interested parties to provide public comments on the proposed rule, given that risk management decisions in the proposed rule will likely serve as a basis from which EPA regulates other chemical substances EPA is evaluating under TSCA Section 6.

Article By: the Government Regulation practice at Bergeson & Campbell, P.C.

For more environmental legal news, click here to visit the National Law Review.

©2022 Bergeson & Campbell, P.C.

EPA OIG Report States Further Efforts Needed to Uphold Scientific Integrity Policy at EPA

On May 20, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report entitled Further Efforts Needed to Uphold Scientific Integrity Policy at EPA.  OIG conducted an Agency-wide survey to determine whether EPA’s Scientific Integrity Policy is being implemented as intended to ensure scientific integrity throughout EPA.  OIG received 4,320 responses (a 23.5 percent response rate), showing that 3,987 respondents were aware of or had some familiarity with the Scientific Integrity Policy.  According to OIG, among those respondents with a basis to judge, the majority (56 percent; 1,025 of 1,842) were satisfied with the overall implementation of the Policy.  OIG states that the survey also revealed some concerns with specific aspects of scientific integrity at EPA, including dissatisfaction with EPA’s culture of scientific integrity (59 percent; 1,425 of 2,402) and the release of scientific information to the public (57 percent; 1,049 of 1,842).  OIG recommends that EPA’s deputy administrator lead an effort to examine the causes associated with the scientific integrity concerns identified in the survey and communicate the results to EPA employees, including planned actions to address the causes.  OIG also made 11 recommendations to the EPA science advisor, including developing procedures for addressing and resolving allegations of scientific integrity violations, communicating the outcomes of reports of scientific integrity violations, and improving the release of scientific information to the public.  OIG states that EPA agreed with its recommendations and provided acceptable corrective actions.  According to OIG, EPA has completed two recommendations, and the others are resolved with corrective actions pending.

©2020 Bergeson & Campbell, P.C.

EPA Registers New Uses for Existing Products to Help Reduce the Spread of Candida auris

On February 12, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of 11 products that have been approved for use to disinfect surfaces against the emerging multidrug-resistant fungus Candida auris (C. auris).  C. auris can cause severe infections and spreads easily among hospitalized patients and nursing home residents.  The 11 products are approved for use against C. auris to disinfect surfaces in hospitals, nursing homes, and other healthcare facilities, to help reduce patient infections.  There were no antimicrobial pesticide products registered specifically for use against C. auris prior these new use registrations.

EPA worked in collaboration with the Centers for Disease Control and Prevention (CDC) and other federal partners to ensure that the products would be effective against C. auris.  Previously, on October 16, 2019, EPA had granted public health exemptions under the provisions of section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as amended, to the CDC, for uses of antimicrobial products, on hard, nonporous surfaces in healthcare settings for disinfection from C. auris.

The 11 products that are now registered for use against C. auris are:

  •  Avert Sporicidal Disinfectant Cleaner (EPA Reg. No. 70627-72);
  •  Blondie (EPA Reg. No. 67619-24);
  •  Dagwood (EPA Reg. No. 67619-25);
  •  Micro-Kill Bleach Germicidal Bleach Wipes (EPA Reg. No. 37549-1);
  •  Oxivir 1 (EPA Reg. No. 70627-74);
  •  Oxivir 1 Wipes (EPA Reg. No. 70627-77);
  •  Oxivir Wipes (EPA Reg. No. 70627-60);
  •  Oxycide™ Daily Disinfectant Cleaner (EPA Reg. No. 1677-237);
  •  Virasept (EPA Reg. No. 1677-226);
  • Wonder Woman Formula B Germicidal Wipes (EPA Reg. No. 9480-12); and
  •  Wonder Woman Formula B Spray (EPA Reg. No. 9480-10).

Because there are few products with C. auris claims at this time, CDC and EPA have identified additional products that are effective against C. auris. Although these products do not yet have formal EPA-registered claims for C. auris, testing at CDC has confirmed they are effective against C. auris.  The label on the product will not include instructions for C. auris.  CDC guidance states to “follow the instructions provided for C. albicans, if included, or else follow those for fungicidal activity.” These products include:

  •  Oxivir TB Spray (EPA Reg. No. 70627-56); and
  •  PDI Super Sani-Cloth (EPA Reg. No. 9480-4).

The CDC Guidance further states that, if none of the above-listed products are available, or any of the EPA-registered products that are newly approved for the specific claims against C. auris, CDC recommends use of an EPA-registered hospital-grade disinfectant effective against Clostridioides difficile spores, because CDC believes these products have been used effectively against C. auris (List K).

Additional information on C. auris is available on EPA’s website and CDC’s website.

©2020 Bergeson & Campbell, P.C.

For more on EPA disinfectant registrations, see the National Law Review Environmental, Energy & Resources section.

Trump Executive Order Seeks to Limit Scope of Clean Water Act

clean water act, EPA, environmental protection agencyThe executive order asks agencies to repeal or revise an Obama-era rule defining the scope of the Clean Water Act and recommends adoption of a narrower standard articulated by the late Justice Scalia.

On February 28, US President Donald Trump issued an executive order asking the US Environmental Protection Agency (EPA) and the US Army Corps of Engineers (Army Corps) to repeal or revise a 2015 rule interpreting the term “waters of the United States,” which determines the jurisdictional reach of the Clean Water Act. The order further recommends that the agencies consider crafting a new definition based on the “continuous surface connection” test adopted by a plurality of the US Supreme Court in Rapanos v. United States, which would result in a significant contraction in the Clean Water Act’s scope from the Obama EPA’s 2015 rule.[1] The 2015 rule was met with extensive criticism by some stakeholders and gave rise to a flurry of litigation. A new rule issued in response to President Trump’s executive order is likely to do the same—resulting in continued uncertainty as to the proper scope of the Clean Water Act and possibly requiring further review by the Supreme Court to resolve the question.

Background

The scope of jurisdiction under the Clean Water Act has long been controversial. It is also an important issue for stakeholders such as farmers, developers, and energy companies that own or use properties that may contain a “water of the United States.” The scope of the act affects the application of a number of regulatory programs, including the section 402 point source discharge permit program, the section 404 dredge and fill permit program, and the section 311 oil spill prevention program.

The Clean Water Act applies to “navigable waters,” which are defined in the statute as “waters of the United States, including territorial seas.” EPA and the Army Corps, the agencies charged with administrating the Clean Water Act, have sought multiple times to define “waters of the United States” through rulemakings and regulatory guidance, and those regulatory efforts have been subject to numerous legal challenges. The US Supreme Court has weighed in on the issue three times, most recently in Rapanos v. United States.[2] Rapanos resulted in a fractured decision in which no interpretation received support from a majority of the court—Justice Antonin Scalia and three other justices articulated a test based on a “continuous surface connection,” while Justice Anthony Kennedy’s concurrence relied on whether there was a “significant nexus” to another water of the United States.[3] Because Justice Kennedy’s analysis provided the narrowest grounds for reversal, the “significant nexus” test has been understood by many as the controlling test post-Rapanos for what constitutes a water of the United States.

In May 2015, EPA and the Army Corps issued a new rule seeking to better define the Clean Water Act’s scope.[4] The agencies maintained that the final rule only clarified and limited the reach of the act, but many stakeholder groups concluded that the 2015 rule significantly expanded the existing interpretation of waters of the United States. Of particular concern to stakeholders were categorical inclusions of “tributaries” and waters “adjacent” to other waters of the United States, as well as the rule’s broad definition of what constitutes a “significant nexus.” Numerous lawsuits challenging the rule were filed, which are currently consolidated in the US Court of Appeals for the Sixth Circuit.

The Executive Order

On February 28, 2017, President Trump issued an executive order asking EPA and the Army Corps to review the 2015 rule and propose a new rule “rescinding or revising” it. The order also asks the agencies to consider defining waters of the United States “in a manner consistent with the opinion of Justice Antonin Scalia in Rapanos v. United States.” The order further directs the US attorney general to take appropriate measures regarding the ongoing litigation over the 2015 rule.

EPA and the Army Corps released a prepublication Federal Register notice the same day noting their intention to “review and rescind or revise” the 2015 rule pursuant to President Trump’s executive order. The agencies also acknowledged that they would consider adopting Justice Scalia’s test from Rapanos.

Implications

It likely will take years for the exact contours of the new regulation to be fleshed out by EPA and the Army Corps and for any ensuing litigation to be resolved. The process likely will start with the withdrawal of the Obama-era rule and the issuance of a new rule, including an explanation as to how the new rule fulfills the legislative intent of the Clean Water Act. The new rule will be subject to a public comment period.

If the agencies’ new rule is indeed based on Justice Scalia’s “continuous surface connection” test from Rapanos, it likely would entail a significant contraction in the scope of the Clean Water Act from existing practices and the Obama EPA’s 2015 rule. For example, a wetland next to a navigable river presumably would be covered by the act only if surface water from the wetland flowed into that river on a year-round basis, regardless of any subsurface flows. Under the 2015 rule, the same wetland could be covered under the act as a water “adjacent” to another water of the United States in the absence of a continuous surface connection. Many tributaries and ephemeral waters also likely no longer would be subject to regulation under the Clean Water Act if the “continuous surface connection” test is adopted. Such changes likely would be hailed by stakeholders that would have been prohibited from engaging in certain activities or obtaining permits under the 2015 rule, but criticized by environmental groups seeking to broadly protect aquatic resources.

Given the stakes and the contentious atmosphere regarding the scope of the Clean Water Act, any new rule is likely to be challenged in court. One issue that may be raised by challengers is whether a rule based on Justice Scalia’s “continuous surface connection” test is consistent with the requirements of the Clean Water Act as interpreted by Supreme Court decisions, including Rapanos. Opponents of the rule could contend that a “continuous surface connection” standard is inconsistent with the Rapanos court’s view of the limits of the Clean Water Act because five justices rejected Scalia’s test as too restrictive, and most lower courts have treated Justice Kennedy’s “significant nexus” test as the operative standard. Proponents of a new rule could counter that such a construction is nonetheless a permissible interpretation of the Clean Water Act (as evidenced by the plurality’s opinion in Rapanos) that is entitled to judicial deference.[5]  

Environmental groups or others opposed to a new rule could also challenge the merits of the rule under the Administrative Procedure Act. Such a challenge could rely in part on the new rule’s departure from the 2015 rule, in which the Obama administration cited extensive scientific findings in support of its interpretation. While agencies can change their position, they must provide a “more detailed justification” if they rely on factual findings contradicting previous ones,[6] potentially heightening the agencies’ burden to provide support for a new rule.

In the interim, jurisdictional determinations under the Clean Water Act are likely to remain in a state of limbo. The 2015 rule has been stayed by the Sixth Circuit, technically leaving the rules and guidance pre-dating 2015 as the operative regulatory regime until the time that the stay is lifted or a new rule is promulgated. In light of the new administration’s expressed intent to limit the scope of the Clean Water Act, EPA and the Army Corps will be unlikely to assert jurisdiction over waters on the borderline of Clean Water Act jurisdiction until this legal limbo is resolved. The currently pending legal challenges also may be held in abeyance or remanded until the promulgation of a new rule, particularly given the executive order’s instruction to the US attorney general to take appropriate actions in pending litigation.

Ultimately, it likely will be years before the scope of the Clean Water Act is sorted out. And it may require a fourth trip to the Supreme Court for the justices to yet again wrestle with what are “waters of the United States.”

Additional Information

Additional information on the controversy that has surrounded efforts to define “waters of the United States” and the regulatory programs affected by the jurisdictional reach of the Clean Water Act can be found in the Clean Water Handbook, Fourth Edition, authored by Duke McCall and available from Bernan Press.

ARTICLE BY Duke K. McCall III, Ella Foley Gannon & Douglas A. Hastings of Morgan, Lewis & Bockius LLP
Copyright © 2017 by Morgan, Lewis & Bockius LLP. All Rights Reserved.

[1] 547 U.S. 715 (2006).

[2] Id.

[3] See id. at 717-18.  

[4] 80 Fed. Reg. 37,054. 

[5] See Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837 (1984).

[6] See FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009).