Tag: EPA

Senate Subcommittee Holds Hearing on Public Health Impacts of PFAS Exposures

On December 5, 2024, the Senate Environment and Public Works (EPW) Subcommittee on Chemical Safety, Waste Management, Environmental Justice, and Regulatory Oversight held a hearing on “Examining the Public Health Impacts of PFAS Exposures.” The Subcommittee heard from the following witnesses (written testimony is not available at this time):

  • Laurel Schaider, Ph.D., Senior Scientist, Environmental Chemistry and Engineering, Silent Spring Institute;
  • Sue Fenton, Ph.D., Director of the Center for Human Health and the Environment, Professor of Biological Sciences, North Carolina State University; and
  • Michael D. Larrañaga, Ph.D., P.E., President and Managing Principal, R.E.M. Risk Consultants, on behalf of the American Industrial Hygiene Association (AIHA).

Schaider testified that there needs to be a comprehensive strategy to address all per- and polyfluoroalkyl substances (PFAS), including fluorinated polymers, as a class. Schaider described how the manufacture of PFAS can expose workers and nearby communities to PFAS and how the disposal of products that contain PFAS can contaminate the environment. Fenton offered a number of suggestions for possible legislation, including: limiting the production and use of PFAS; requiring health insurance companies to pay for PFAS testing in susceptible populations; phasing out PFAS in firefighting foams (FFF); requiring manufacturers to provide standards in purified forms of their PFAS; and requiring PFAS manufacturers to fund the development of safe destruction methods for PFAS. Larrañaga stated that PFAS are part of our critical infrastructure and are used in the manufacture of products such as semiconductors, electronics, medical equipment, pharmaceuticals, herbicides, insecticides, plastics, airplanes, automobiles, and buildings. Larrañaga urged that the use of PFAS be balanced against the risk of alternatives.

The hearing included discussion of the use of PFAS in consumer products, including non-stick pans and waterproof mascara, versus other products, such as cell phones and semiconductors. Schaider stated that the issue is not only non-essential uses of PFAS, as in cookware, but also the lifecycle of products that contain PFAS. There may be environmental contamination in communities where PFAS are manufactured, workers may be exposed during manufacture, and at the end of the lifecycle of the product, the PFAS could end up in a landfill or in emissions when incinerated.

During the hearing, Senator Roger Wicker (R-MS) asked whether all PFAS cause the same level of harm and noted the common definition of PFAS as “any compound containing at least one fully fluorinated carbon atom.” Larrañaga responded that although fluoropolymers contain one fully fluorinated carbon atom, they are less bioavailable than other PFAS of concern. There could be an issue if heating them, but by removing that use from the marketplace, instead of banning all PFAS, there would be no adverse effect to critical infrastructure or defense. Schaider stated that, to her knowledge, no PFAS is completely safe. According to Schaider, newer PFAS replacement chemicals raise many of the same health concerns. Schaider suggested that an essential uses framework could be used to identify where PFAS uses can be reduced immediately.

The hearing included discussion of the best way to move forward. Fenton noted that even for essential uses, there is potential exposure to the waste and that proper disposal is important. According to Fenton, labeling products with intentionally added PFAS would allow consumers to make more informed choices. Subcommittee Chair Jeff Merkley (D-OR) suggested that there may be product categories where labeling is more important because the contamination pathway is more significant. Merkley concluded that Congress should continue to explore how to reduce the risk of PFAS to citizens.

There is much discussion, seemingly everywhere, about PFAS, but no easy answers to the questions the Subcommittee considered. In a perfect world, PFAS would be comprehensively addressed as Schaider recommends, and all the unknowns about disposal, exposure, and toxicity would be known. But we do not live in that world, and many hard questions remain to be answered. The Subcommittee gets points for raising key issues, but did little to move the needle.

All eyes are now on the new kids in town — the incoming Trump Administration and U.S. Environmental Protection Agency (EPA) Administrator-Designate Lee Zeldin. We expect in 2025 a decidedly different focus on PFAS, but beyond this, much remains to be seen.

©2024 Bergeson & Campbell, P.C.
For more on the PFAS, visit the NLR Environmental Energy Resources section

White House OSTP Releases PFAS Federal R&D Strategic Plan

The White House Office of Science and Technology Policy (OSTP) announced on September 3, 2024, the release of its Per- and Polyfluoroalkyl Substances (PFAS) Federal Research and Development Strategic Plan (Strategic Plan). Prepared by the Joint Subcommittee on Environment, Innovation, and Public Health PFAS Strategy Team (PFAS ST) of the National Science and Technology Council, the Strategic Plan provides a federal strategy and implementation plan for addressing the strategic areas identified in the 2023 Per- and Polyfluoroalkyl Substances (PFAS) Report (PFAS Report). The Strategic Plan is intended to be a companion document to the PFAS Report. The activities described in the Strategic Plan are reviewed through the Office of Management and Budget (OMB) annual budget process and subject to available resources.

Background

As reported in our March 16, 2023, blog item, the PFAS Report provides an analysis of the state of the science of PFAS and information that will be used to direct the development of a federal strategic plan. The PFAS Report focuses on the current science of PFAS as a chemical class, identifies scientific consensus, and portrays uncertainties in the scientific information where consensus is still sought. The PFAS Report identifies four key strategic areas that, when addressed, will generate actionable information to address PFAS: removal, destruction, or degradation of PFAS; safer and environmentally friendlier alternatives; sources and pathways of exposure to PFAS; and toxicity of PFAS. The gaps and opportunities identified in the PFAS Report were used to develop the Strategic Plan.

Strategic Plan

Based on the four strategic areas presented in the 2023 PFAS Report, the PFAS ST identified four strategic goals that will drive federal research and development (R&D) efforts regarding PFAS:

  • Provide relevant, high-quality scientific data that increase the understanding of PFAS exposure pathways to inform federal decisions that reduce risks to human health and the environment;
  • Effectively and equitably communicate federal work and results regarding PFAS R&D through engagement with impacted communities and federal, Tribal, state, and local agencies;
  • Identify research and technologies to address PFAS contamination and mitigate the adverse impacts on communities; and
  • Generate information that facilitates informed procurement decisions by federal agencies, manufacturers, and consumers regarding products that contain or use PFAS and PFAS alternatives to reduce adverse human health and environmental effects.

According to the Strategic Plan, the PFAS ST identified five R&D strategies within the strategic research areas that address the identified knowledge gaps. The R&D strategies and select tasks to achieve the objectives within each strategy include:

  • Understand PFAS exposure pathways to individuals and communities:
    • Further characterize potential PFAS exposures in the built environment, including schools, workplaces, and other indoor/household environments. According to the Strategic Plan, this would include the co-occurrence and use of consumer products and understanding the lifecycle of products with regard to PFAS exposure;
    • Initiate studies regarding PFAS co-exposure and potential interactions with other contaminants (including other PFAS) in environmental samples, such as nano- and microplastics, petroleum constituents, metals, pesticides, and pharmaceuticals;
    • Initiate and continue studies of the physical-chemical properties of PFAS and mixtures of PFAS;
    • Investigate additional pathways and routes of exposure, such as direct contact, dermal absorption, oral ingestion, and inhalation from indoor and outdoor environments (residential, consumer, and occupational exposures); and
    • Develop and support studies of PFAS exposures in indoor environments through collection of dust, air, consumer products, and other media where biomonitoring may also be conducted;
  • Address current PFAS measurement challenges through the development of standards, advanced sampling, and analytical methodologies:
    • Develop and refine analytical methods and data collection methods to evaluate PFAS content, migration, and emissions from consumer, commercial, and industrial products, and their impact on workplace and indoor environments;
    • Develop testing programs and methods related to quantifying PFAS content, migration, and emissions in animal/livestock feed, food and food packaging, indoor exposure (dust, home/office materials), workplace settings, and consumer products; and
    • Develop and validate real-time, rapid, and remote PFAS screening methods using analytical sensors, PFAS proxies, passive sampling devices, and other novel technologies for the detection of PFAS in media;
  • Understand the toxicological mechanisms, human and environmental health effects, and risks of PFAS exposure:
    • Develop scientifically supported classification schemes for PFAS with respect to adverse impacts on human health and the environment;
    • Develop and support research regarding the human toxicity and ecotoxicity testing of PFAS as mixtures with PFAS and other co-occurring chemicals;
    • Support research to understand further the mechanism of action of PFAS toxicity, advance development of adverse outcome pathways, and understand the impact of PFAS mixture toxicities when evaluating cumulative health effects;
    • Develop and support epidemiological studies designed to identify communities near significant sources of PFAS contamination that may have environmental justice concerns, including occupationally exposed populations and populations, communities, and/or lifestages that are more susceptible to PFAS exposure or adverse health outcomes;
    • Explore the development of a federal data-sharing strategy to use interagency toxicological and epidemiological data to determine human health endpoints of concern from PFAS exposure; and
    • Develop classification strategies that enable grouping of PFAS by hazard identification, exposure assessment, and dose-response studies in support of risk assessments;
  • Develop, evaluate, and demonstrate technologies for the removal, destruction, and disposal of PFAS:
    • Continue to support the foundational research that advances technologies for the destruction of PFAS by both thermal and non-thermal approaches;
    • Support the implementation of removal and destruction technologies that apply to discharge and releases at the point of manufacturing; and
    • Develop and implement models to evaluate technology performance, short-term and long-term costs, energy demands, scalability, and the composition of treated materials that are released to the environment;
  • Identify PFAS alternatives and evaluate their human health and environmental effects:
    • Engage with academic and private sector industrial researchers to support the development of novel, less toxic alternative chemistries and processes for sustainable PFAS alternatives;
    • Identify and evaluate critical and essential uses of PFAS within individual agencies and sectors;
    • Develop an interagency-aligned evaluation framework for prioritizing research on specific PFAS alternatives that includes considerations regarding sustainability; performance; viability and timeframe to transition; dependency on foreign sources of materials; criticality of the current product to national security, critical infrastructure, climate change mitigation, and public health; and criticality of the need for a replacement product or process;
    • Support research to advance sustainable manufacturing and circularity of PFAS-based processes and products to preserve current critical and essential uses, which will enable an orderly transition to PFAS alternatives in critical manufacturing sectors that are dependent on PFAS;
    • Develop a database of the current commercial inventory of alternative materials and products with relevant chemical and toxicological information, manufacturer production capacity, and performance comparison of the alternatives to PFAS-containing materials and products; and
    • Continue to assess human health and environmental effects posed by alternative materials and products for use in comparison to other product formulations, including PFAS-containing product formulations.

Commentary

Bergeson & Campbell, P.C. (B&C®) acknowledges that OSTP’s PFAS Strategy may benefit from the U.S. Environmental Protection Agency’s (EPA) regulatory activities under the Toxic Substances Control Act (TSCA) and other initiatives. We provide below representative examples of these activities.

Between 2022 and 2024, EPA issued TSCA Section 4 test orders requiring manufacturers and/or processors to perform various studies on four PFAS (i.e., 6:2 fluorotelomer sulfonamide betaine [6:2 FTSB], trifluoro(trifluoromethyl)oxirane [HFPO], 2,3,3,3-tetrafluoro-2-heptafluoropropoxy) propanoyl fluoride [HFPO-DAF], and 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-Heptadecafluoro-N-(2-hydroxyethyl)-N-methyloctane-1-sulfonamide [NMeFOSE]).

EPA also intends on initiating ten additional TSCA Section 4 test orders per year on PFAS between fiscal year (FY) 2024 and FY 2026 (i.e., October 1, 2024-September 30, 2027). EPA’s activities under TSCA Section 4 may lead to the development of data that provide a better understanding of the human health and environmental effects of specific types of PFAS.

The TSCA Section 8(a)(7) rule on the reporting and recordkeeping of manufacture and import of PFAS will provide additional information on PFAS uses, production volumes, disposal, exposures, and hazards. In addition, EPA’s publication of its updated PFAS category analysis may help frame how to use data on PFAS for which testing has been (or is in the process of being) completed to fill data gaps on related PFAS.

Further, EPA’s Office of Research and Development (ORD) and Office of Land Use and Emergency Management (OLEM) have made significant contributions on analytical methods for detecting PFAS in various media and guidance for destroying and disposing of PFAS and PFAS-containing materials, respectively. The TSCA Section 8(a)(7) information along with EPA’s advancements with identifying PFAS in environmental media may aid with identifying those PFAS and the associated uses that lead to the greatest environmental releases.

Collectively, EPA’s activities on PFAS will advance the objectives of OSTP’s PFAS Strategy. This information may also aid with differentiating the types of PFAS that present the greatest concerns to human health and the environment versus those chemistries that do not. After all, many chemical substances, including pharmaceuticals and pesticides, meet one or more of the existing definitions for PFAS and have clear public health benefits, yet do not present the same concerns as those PFAS that have significant concerns (e.g., perfluorooctanoic acid).

©2024 Bergeson & Campbell, P.C.
For more news on PFAS Federal R&D Strategic Plans, visit the NLR Environmental Energy Resources section.

EPA Bans Ongoing Uses of Chrysotile Asbestos

On March 28, 2024, the U.S. Environmental Protection Agency (EPA) issued a final rule under the Toxic Substances Control Act (TSCA) to address to the extent necessary the unreasonable risk of injury to health presented by chrysotile asbestos based on the risks posed by certain conditions of use (COU). 89 Fed. Reg. 21970. According to the final rule, the injuries to human health include mesothelioma and lung, ovarian, and laryngeal cancers resulting from chronic inhalation exposure to chrysotile asbestos. The final rule prohibits the manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos for chrysotile asbestos diaphragms in the chlor-alkali industry; chrysotile asbestos-containing sheet gaskets in chemical production; chrysotile asbestos-containing brake blocks in the oil industry; aftermarket automotive chrysotile asbestos-containing brakes/linings; other chrysotile asbestos-containing vehicle friction products; and other chrysotile asbestos-containing gaskets. It also prohibits the manufacture (including import), processing, and distribution in commerce for consumer use of aftermarket automotive chrysotile asbestos-containing brakes/linings; and other chrysotile asbestos-containing gaskets. The final rule specifies the compliance dates for these prohibitions. The final rule also includes disposal and recordkeeping requirements for these COUs. The final rule will be effective May 28, 2024.

Manufacturing, Processing, Distribution in Commerce, and Commercial Use of Chrysotile Asbestos Diaphragms in the Chlor-alkali Industry

As of the effective date of the final rule, all persons are prohibited from the manufacture (including import) of chrysotile asbestos, including any chrysotile asbestos-containing products or articles, for diaphragms in the chlor-alkali industry. Beginning five years after the effective date of the final rule, all persons are prohibited from processing, distribution in commerce, and commercial use of chrysotile asbestos for diaphragms in the chlor-alkali industry, except as provided in 40 C.F.R. Section 751.505(c) and (d).

Section 751.505(c) permits a person to process, distribute in commerce, and commercially use chrysotile asbestos for diaphragms in the chlor-alkali industry at no more than two facilities until eight years after the effective date of the final rule, provided that they meet certain conditions.

Section 751.505(d) permits a person who meets all of the criteria of that paragraph to process, distribute in commerce, and commercially use chrysotile asbestos for diaphragms in the chlor-alkali industry at not more than one facility until 12 years after the effective date of the final rule, provided that they meet certain conditions.

Certification of Compliance for Chlor-alkali Industry

A person who processes, distributes in commerce, or commercially uses chrysotile asbestos for diaphragms in the chlor-alkali industry between five years and eight years after the effective date of the final rule must certify to EPA their compliance with all requirements of Section 751.505(c) and provide the following information to EPA: identification of the facility (or facilities) at which, by five years after the effective date of the final rule, the person has ceased all processing, distribution in commerce, and commercial use of chrysotile asbestos; identification of the one or two facilities (no more than two facilities) at which the person will after five years after the effective date of the final rule continue to process, distribute in commerce, and commercially use chrysotile asbestos diaphragms while the facility or facilities are being converted to non-chrysotile asbestos membrane technology; and the name of the facility manager or other contact.

A person who processes, distributes in commerce, or commercially uses chrysotile asbestos for diaphragms in the chlor-alkali industry between eight and 12 years after the effective date of the final rule must certify to EPA their compliance with all requirements of Section 751.505(d) and provide the following information to EPA: identification of the facility at which the person has ceased all processing, distribution in commerce, and commercial use of chrysotile asbestos after five years after the effective date of the final rule but no later than eight years after the effective date of the final rule; identification of the facility at which the person will between eight years after the effective date of the final rule and no later than 12 years continue to process, distribute in commerce, and commercially use chrysotile asbestos diaphragms while the facility is being converted to non-chrysotile asbestos membrane technology pursuant to Section 751.505(d); and the name of the facility manager or other contact.

Other Prohibitions of and Restrictions on the Manufacturing, Processing, Distribution in Commerce, and Commercial Use of Chrysotile Asbestos

Prohibition on Manufacture (Including Import), Processing, Distribution in Commerce, and Commercial Use of Chrysotile Asbestos for Chrysotile Asbestos-Containing Sheet Gaskets in Chemical Production

Beginning two years after the effective date of the final rule, all persons are prohibited from manufacturing (including importing), processing, distributing in commerce, and commercial use of chrysotile asbestos, including any chrysotile asbestos-containing products or articles, for use in sheet gaskets for chemical production, except as provided in Section 751.509(b) and (c). Any sheet gaskets for chemical production that are already installed and in use as of the applicable compliance date are not subject to this distribution in commerce and commercial use prohibition, however.

Section 751.509(b) allows the commercial use of chrysotile asbestos sheet gaskets for titanium dioxide production past the general two-year prohibition; any person may use chrysotile asbestos sheet gaskets for titanium dioxide production until five years after the effective date of the final rule. EPA notes that this provision applies only to commercial use; manufacturing (including import), processing, and distribution in commerce must cease after two years, pursuant to Section 751.509(a).

Section 751.509(c) allows the commercial use of chrysotile asbestos sheet gaskets for processing of nuclear material past the general two-year prohibition: any person who meets the applicable criteria in the paragraph may commercially use chrysotile asbestos sheet gaskets for processing nuclear material until five years after the effective date of this final rule. At the Department of Energy’s Savannah River Site, use may continue until the end of 2037. EPA notes that this provision applies only to commercial use; manufacturing (including import), processing, and distribution in commerce must cease after two years. Section 751.509(c) requires that, beginning 180 days after the effective date of the final rule, all persons commercially using chrysotile asbestos sheet gaskets for processing nuclear material must have in place exposure controls expected to reduce exposure of potentially exposed persons to asbestos, and provide potentially exposed persons in the regulated area where chrysotile asbestos sheet gasket replacement is being performed with a full-face air purifying respirator with a P-100 (HEPA) cartridge (providing an assigned protection factor of 50), or other respirators that provide a similar or higher level of protection to the wearer.

Prohibition on Manufacture (Including Import), Processing, Distribution in Commerce, and Commercial Use of Chrysotile Asbestos-Containing Brake Blocks in the Oil Industry; Aftermarket Automotive Chrysotile Asbestos-Containing Brakes/Linings; Asbestos-Containing Vehicle Friction Products; and Other Asbestos-Containing Gaskets

Beginning 180 days after the effective date of the final rule, all persons are prohibited from manufacturing (including importing), processing, distribution in commerce, and commercial use of chrysotile asbestos, including any chrysotile asbestos-containing products or articles, for commercial use of: oilfield brake blocks; aftermarket automotive brakes and linings; other vehicle friction products; and other gaskets. Any aftermarket automotive brakes and linings, other vehicle friction products, and other gaskets that are already installed and in use as of 180 days after the effective date of the final rule are not subject to this distribution in commerce and commercial use prohibition.

Prohibition on Manufacture (Including Import), Processing, and Distribution in Commerce for Aftermarket Automotive Chrysotile Asbestos-Containing Brakes/Linings and Other Asbestos-Containing Gaskets for Consumer Use

Beginning 180 days after the effective date of the final rule, all persons are prohibited from the manufacturing (including importing), processing, and distribution in commerce of chrysotile asbestos, including any chrysotile asbestos-containing products or articles, for consumer use of: aftermarket automotive brakes and linings; and other gaskets. Any aftermarket automotive brakes and linings and other gaskets that are already installed and in consumer use as of 180 days after the effective date of the final rule are not subject to this distribution in commerce prohibition.

EPA notes that this prohibition does not apply to the consumer use of any chrysotile asbestos-containing aftermarket automotive brakes and linings and other gaskets. EPA states that its authority to regulate commercial use under TSCA Section 6(a)(5) does not extend to consumer use of chemical substances or mixtures. According to EPA, the prohibition on the upstream manufacturing, processing, and distribution of chrysotile asbestos aftermarket automotive brakes and linings and other gaskets for consumer use “will remove these products from the consumer market and over time eliminate their use as these products wear out and are replaced, or the vehicles in which they are components are retired from use.”

Interim Workplace Controls of Chrysotile Asbestos Exposures

For most of the COUs where, pursuant to the final rule, the prohibition on processing and industrial use will take effect in five or more years after the effective date of the final rule, EPA requires owners or operators to comply with an eight-hour existing chemical exposure limit (ECEL), beginning six months after the effective date of the final rule. EPA notes that this requirement applies to the following COUs:

  • Processing and industrial use of chrysotile asbestos in bulk form or as part of chrysotile asbestos diaphragms used in the chlor-alkali industry; and
  • Industrial use of chrysotile asbestos sheet gaskets for titanium dioxide production.

Once a facility has completed the phase-out of chrysotile asbestos and no longer uses chrysotile asbestos in its operations, the interim requirements no longer apply.

EPA states that its intention “is to require interim workplace controls that address the unreasonable risk from chrysotile asbestos to workers directly handling the chemical or in the area where the chemical is being used until the relevant prohibitions go into effect.” EPA notes that its 2020 Risk Evaluation for Asbestos, Part 1: Chrysotile Asbestos (Asbestos Part I) “did not distinguish between employers, contractors, or other legal entities or businesses that manufacture, process, distribute in commerce, use, or dispose of chrysotile asbestos. For this reason, EPA uses the term “owner or operator” to describe the entity responsible for implementing the interim workplace controls in any workplace where an applicable COU subject to the interim workplace controls occurs. The term includes any person who owns, leases, operates, controls, or supervises such a workplace. EPA has proposed to amend 40 C.F.R. Section 751.5 to add a definition of “owner or operator” consistent with this description as part of its proposed TSCA Section 6(a) rules to regulate methylene chloride and perchloroethylene. In this final rule, EPA uses the same definition of “owner or operator” to apply to where it appears in the regulatory text for chrysotile asbestos.

EPA notes that, as mentioned in the proposed rule, TSCA risk management requirements could incorporate and reinforce requirements in Occupational Safety and Health Administration (OSHA) standards. For chrysotile asbestos, EPA states that its approach for interim controls seeks to align, to the extent possible, with certain elements of the existing OSHA standard for regulating asbestos under 29 C.F.R. Sections 1910.1001 and 1926.1101. According to EPA, the OSHA permissible exposure limit (PEL) and ancillary requirements “have established a long-standing precedent for exposure limit threshold requirements within the regulated community.” EPA acknowledges that it is applying a “lower, more protective” ECEL derived from Asbestos Part I. EPA notes that it is not establishing medical surveillance requirements based on the ECEL to align with those under 29 C.F.R. Section 1910.1001, however, and that companies must continue to follow the medical surveillance requirements established by OSHA at 0.1 fiber per cubic centimeter of air as an eight-hour time-weighted average (TWA) level.

Disposal

EPA states that it is implementing the disposal provisions in the proposed rule without significant changes. EPA notes that the disposal provisions at Section 751.513 cross reference existing EPA and OSHA regulations that address asbestos-containing waste disposal. EPA requires that for the chrysotile asbestos diaphragm COU, as well as oilfield brake blocks, other vehicle friction products, and any commercial use of other gaskets and aftermarket automotive brakes and linings COUs, regulated entities must adhere to waste disposal requirements in OSHA’s Asbestos General Industry Standard in 29 C.F.R. Section 1910.1001, including Section 1910.1001(k)(6) requiring waste, scrap, debris, bags, containers, equipment, and clothing contaminated with asbestos that are consigned for disposal to be disposed of in sealed impermeable bags or other closed, impermeable containers. For the chrysotile asbestos sheet gaskets in the chemical production COU, regulated entities must adhere to waste disposal requirements described in OSHA’s Asbestos Safety and Health Regulations for Construction in 29 C.F.R. Section 1926.1101.

EPA notes that additionally, for the chrysotile asbestos diaphragm COU, as well as oilfield brake blocks, other vehicle friction products, and any commercial use of other gaskets and aftermarket automotive brakes and linings, the final rule cross-references the disposal requirements of Asbestos National Emission Standards for Hazardous Air Pollutants (NESHAP) (40 C.F.R. Part 61, Subpart M) at 40 C.F.R. Section 61.150. EPA states that the asbestos NESHAP reduces exposure to airborne asbestos “by generally requiring sealing of asbestos-containing waste material from regulated activities in a leak-tight container and disposing of it in a landfill permitted to receive asbestos waste.” According to EPA, it is not cross-referencing this same NESHAP waste disposal provision for the disposal of chrysotile asbestos-containing waste from sheet gasket processing and use “because EPA did not find unreasonable risk for the disposal of sheet gaskets.”

EPA also requires that each manufacturer (including importer), processor, and distributor of chrysotile asbestos, including as part of products and articles for consumer uses subject to the final rule, dispose of regulated products and articles in accordance with specified disposal provisions. EPA states that these consumer uses are aftermarket automotive brakes and linings and other gaskets. EPA notes that these consumer use supply chain disposal requirements are consistent with those for disposers of aftermarket automotive brakes and linings and other gaskets intended for commercial use. EPA states that it “does not generally have TSCA section 6(a) authority to directly regulate consumer use and disposal, but under TSCA section 6(a) EPA may nonetheless regulate the disposal activity of suppliers of these products, including importers, wholesalers and retailers of asbestos-containing aftermarket automotive brakes and linings, and other gaskets.” The disposal requirements at Section 751.513 will take effect 180 days after the effective date of the final rule.

Recordkeeping

A general records provision at 40 C.F.R. Section 751.515(a) of the final rule requires that, beginning 180 days after the effective date of the final rule, all persons who manufacture (including import), process, distribute in commerce, or engage in industrial or commercial use of chrysotile asbestos must maintain ordinary business records, such as invoices and bills-of-lading related to compliance with the prohibitions, restrictions, and other provisions of this rulemaking and must make them available to EPA for inspection. Section 751.515(b) addresses recordkeeping for certifications of compliance for the chlor-alkali industry required under Section 751.507 of the rule: persons must retain records for five years to substantiate certifications required under that provision and must make them available to EPA for inspection.

Section 751.515(c) of the final rule requires retention of records for interim workplace controls of chrysotile asbestos exposures. The final rule requires owners or operators subject to the exposure monitoring provisions of Section 751.511(c) to document and retain records for each monitoring event. Additionally, Section 751.515(c) requires that owners or operators subject to the interim workplace controls described in Section 751.511 retain certain records.

Section 751.515(d) requires the retention of disposal records. Each person, except a consumer, who disposes of any chrysotile asbestos and any chrysotile asbestos-containing products or articles subject to Section 751.513, beginning 180 days after the effective date of the final rule, must retain in one location at the headquarters of the company, or at the facility for which the records were generated: any records related to any disposal of chrysotile asbestos and any chrysotile asbestos-containing products or articles generated pursuant to, or otherwise documenting compliance with, regulations specified in Section 751.513. All records under this rule must be retained for five years from the date of generation.

Commentary

Bergeson & Campbell, P.C. (B&C®) acknowledges the historic nature of the rule, but it must also be placed into context. First, the rule applies to the few, limited ongoing uses of chrysotile asbestos that were not banned in the 1980s. It does not apply to the asbestos types that may already be in place, such as in old buildings. A ban on the manufacture, import, processing, and use of chrysotile asbestos cannot erase other types of asbestos, including chrysotile asbestos, that are and have been in place for decades. EPA’s Asbestos Part 2 risk evaluation will address the potential risk from such legacy uses and associated disposal activities. That work is underway. Second, EPA concluded that for the limited, ongoing uses of chrysotile asbestos, the only way to mitigate the risk of ongoing import, processing, use, and disposal is to ban chrysotile asbestos, except for the narrow use in brakes on specialized, large cargo aircraft operated by the National Aeronautics and Space Administration (NASA).

In its risk evaluation, EPA concluded that the use of chrysotile asbestos in chlor-alkali production does not present an unreasonable risk if protective measures are used, such as engineering controls, glove boxes, and personal protective equipment (PPE). In the final risk management rule, EPA nevertheless argues that chrysotile asbestos must be banned because the necessary PPE may not be used correctly. If this logic prevails, EPA may be in the awkward situation of needing to ban every substance that it determines as presenting an unreasonable risk when PPE is not used, meaning that EPA will have to ban nearly every substance it reviews under TSCA Section 6 (at least for the foreseeable future) because it is likely that all substances that EPA will review in the next several decades will be sufficiently hazardous for EPA to conclude that the chemical substances present an unreasonable risk from routine, unprotected inhalation and/or dermal exposures. EPA seems to be saying that someone, somewhere, under some circumstances, may decide not to wear protective measures, or not wear PPE correctly and that because of this instance, EPA cannot reduce an unreasonable risk by imposing workplace protective measures. EPA might view asbestos as a special case, but EPA did not qualify its argument in the rule.

EPA’s cost benefit analysis is surprising: EPA estimates benefits from avoided cancer cases to be between $3,000 and $6,000 per year. This is surprising in that a hazardous chemical apparently leads to so little economic benefits if asbestos is banned. The modest value would appear to be evidence that ongoing uses of chrysotile asbestos are largely not a significant health risk. In comparison, EPA’s economic analysis estimated costs ranging from $34 million to $43 million per year of implementing the rule.

EPA’s progress with advancing its TSCA Section 6 rulemaking activities on chrysotile asbestos is commendable. There are, however, several issues with EPA’s Asbestos Part I that are still unresolved and will likely resurface as the bases for any potential challenges to EPA’s rule. The first issue is EPA’s use of the now rescinded 2018 Application of Systematic Review in TSCA Risk Evaluations (the 2018 SR Document). We previously discussed our concerns with EPA’s use of this approach in Asbestos Part I. The crux of the issue is that the U.S. National Academies of Sciences, Engineering, and Medicine (NASEM) reviewed the 2018 SR Document and concluded that “The OPPT approach to systematic review does not adequately meet the state-of-practice.” This conclusion supports that EPA did not fulfill its obligations of complying with the scientific standards under TSCA Section 26. For further discussion, see our memorandum dated April 7, 2022.

The second related issue is EPA’s derivation of an inhalation unit risk (IUR) for chrysotile asbestos and its subsequent use of the IUR for establishing an ECEL. EPA derived the IUR on textile worker populations from two facilities and stated the following in Asbestos Part I: “The epidemiologic studies that are reasonably available include populations exposed to chrysotile asbestos, which may contain small, but variable amounts of amphibole asbestos.” EPA’s use of these studies was controversial and included criticisms in the peer-reviewed literature with one group of experts pointing out that “All 8 cases of pleural cancer and mesothelioma in the examined populations arose in facilities where amphiboles were present.” The same group of experts also stated that “the suggested inhalation unit risk (IUR) for chrysotile asbestos was far too high since it was not markedly different than for amosite, despite the fact that the amphiboles are a far more potent carcinogen.”

It is unclear if EPA’s study selection for deriving the IUR and exclusion of other studies was due to a flawed systematic review process or other issues, such as favoring a pre-determined outcome. The same group of experts mentioned above stated the following about EPA’s peer review on the draft version of Asbestos Part I:

[A] key limitation of the EPA meeting was that the questions that the panelists were asked to address, termed “charge questions,” did not focus on the most pertinent aspects of the document. Thus, by asking questions that avoided the thorny topics regarding chrysotile asbestos which were often poorly focused, the EPA failed to obtain relevant topical insight from the advisory panel.

Readers may find the above statements implausible, yet EPA’s sponsored peer-review activities on formaldehyde supports that they are not. On August 9, 2023, NASEM issued its report titled Review of EPA’s 2020 Draft Formaldehyde Assessment. NASEM stated the following in its report:

The committee…was not charged with commenting on other interpretations of scientific information relevant to the hazards and risks of formaldehyde, nor did its statement of task call for a review of alternative opinions on EPA’s formaldehyde assessment.

The concern with limiting the scope of a peer review is that doing so, at a minimum, creates an appearance of favoring a pre-determined outcome and may ultimately undermine the integrity of the science used in EPA’s decision-making. Either outcome is inconsistent with the scientific standards under TSCA Section 26 and EPA’s recently updated draft Scientific Integrity Policy.

The third issue relates to EPA’s unreasonable risk determination in Asbestos Part I. EPA referenced its 1994 Guidelines for Statistical Analysis of Occupational Exposure Data (the 1994 Guidelines) as the justification for evaluating monitoring samples that were below the limit of detection (LOD). EPA stated that the 1994 Guidelines “call for replacing non-detects with the LOD or LOQ [limit of quantification] divided by two or divided by the square root of two, depending on the skewness of the data distributions.” EPA also stated that “more than half of the samples were non-detectable.” The approach in the 1994 Guidelines conflicts with EPA’s 2008 Framework for Investigating Asbestos-Contaminated Superfund Sites (the 2008 Framework), which states “[w]hen computing the mean of a set of asbestos measurements, samples that are ‘nondetect’ should be evaluated using a value of zero, not ½ the analytical sensitivity [footnote omitted].” EPA did not state its rationale for not using the 2008 Framework recommendations (i.e., replacing non-detects with zero). EPA is, however, aware of the 2008 Framework, as evidenced by its use of the 2008 Framework for estimating cancer risks for less than lifetime exposure from inhalation of chrysotile asbestos.

It is not clear whether the rule will be challenged, but B&C would not be surprised if impacted industries, non-governmental organizations, and other stakeholder groups bring suit. The scientific methods and documents supporting this rule have been publicly challenged specifically, as discussed above, and generally by other expert academics in the field. This is, after all, the first final rule under TSCA Section 6(a) and will be precedent setting for other risk management rules. This rule is not just about asbestos; it reflects how EPA will manage risks for existing chemical substances EPA identifies as high-priority substances under TSCA Section 6. Stay tuned.

©2024 Bergeson & Campbell, P.C.

EPA Delays TSCA PFAS Reporting Deadlines

The Environmental Protection Agency (EPA) just issued a direct final rule amending reporting deadlines for per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA).

As described in our prior client alert, EPA finalized a rule last fall that requires entities that manufacture (including import) or have manufactured PFAS in any year since January 1, 2011 to submit a one-time comprehensive report regarding PFAS uses, production volumes, byproducts, disposal, exposures, and environmental or health effects.

Since EPA is still developing its reporting application to collect this data, and it will not be fully functional by November 2024, EPA has bumped back the start of the data submission period from November 12, 2024 to July 11, 2025.

The data submission period now ends on January 11, 2026, except for article importers that are also considered small manufacturers. Their submission period will end on July 11, 2026.

EPA is not proposing any changes to the scope of reporting under TSCA.

©2024 Pierce Atwood LLP. All rights reserved.
For more news on EPA TSCA Reporting, visit the NLR Environmental Energy Resources section.

Handling an EPA Inspection: What to Do Before, During, and After the Process

Regardless of a company’s environmental compliance record, facing a U.S. Environmental Protection Agency (EPA) inspection can present significant risks. When conducting inspections, EPA inspectors and technical personnel examine all aspects of companies’ operations, and it is up to companies to demonstrate that enforcement action is unwarranted. When faced with uncertainty, EPA personnel will err on the side of non-compliance with EPA regulations, and this means that companies that are unable to affirmatively demonstrate compliance can find themselves facing unnecessary consequences under federal environmental laws.

With this in mind, all companies need to take an informed, strategic, and systematic approach to defending against EPA inspections. While EPA inspections can present significant risks, companies can—and should—manage these risks effectively. Effectively managing the risks of an EPA inspection starts with understanding what companies need to do before, during, and after the process.

To be clear, while there are several steps that companies can—and generally should—take to prepare for their EPA inspections, there is no single “right” way to approach the inspection process. A custom-tailored approach is critical, as companies facing scrutiny from the EPA must be prepared to address any and all compliance-related concerns arising out of their specific operations.

What to Do Before an EPA Inspection

With this in mind, what can companies do to maximize their chances of avoiding unnecessary consequences during an EPA inspection? Here are five steps that companies should generally take upon learning of an impending visit from EPA personnel:

1. Make Sure You Know What Type of EPA Inspection Your Company is Facing 

One of the first steps to take is to ensure that you know what type of EPA inspection your company is facing. The EPA conducts multiple types of inspections, each of which involves its own protocols and procedures and presents its own risks and opportunities. As the EPA explains:

“Inspections are usually conducted on single-media programs such as the Clean Water Act, but can be conducted for more than one media program. Inspections also can be conducted to address a specific environmental problem (e.g., water quality in a river), a facility or industry sector (e.g., chemical plants), or a geographic (e.g., a region or locality) or ecosystem-based approach (e.g., air or watershed).”

Under the EPA’s current approach to environmental compliance enforcement, most inspections fall into one of five categories:

  • On-Site Inspections – The EPA routinely conducts on-site inspections. During these inspections, EPA personnel may observe the company’s operations, collect samples, take photos and videos, interview company personnel, and review pertinent environmental compliance documentation.
  • Evaluations – The EPA conducts evaluations to assess facility-level compliance under the various federal environmental statutes. These evaluations may be either “full” or “partial,” with full compliance evaluations (FCEs) examining all pertinent areas of compliance and partial compliance evaluations (PCEs) “focusing on a subset of regulated pollutants, regulatory requirements, or emission units at a given facility.”
  • Record Reviews – Record reviews typically take place at an EPA field office or other government location, and they “may or may not be combined with field work.” With that said, in many cases, on-site inspections and record reviews go hand-in-hand.
  • Information Requests – An information request is, “an enforceable, written request for information to a regulated entity, a potentially regulated entity, or a potentially responsible party about a site, facility, or activity.” The EPA uses information requests to “substantiate the compliance status of [a] facility or . . . site,” and the EPA may issue an information request either in connection with or after conducting an on-site inspection.
  • Civil Investigations – The EPA describes civil investigations as, “an extraordinary, detailed assessment of a regulated entity’s compliance status, which requires significantly more time to complete than a typical compliance inspection.” In most cases, a civil investigation will follow an inspection that uncovers significant or systemic compliance failures.

2. Make Sure You Understand the Scope of the EPA’s Inspection 

After discerning the nature of the EPA’s inquiry, the next step is to ensure that you understand its scope. Is the EPA focusing on a specific environmental statute (i.e., the Recovery Act, the Clean Air Act (CAA) or Clean Water Act (CWA)); or, is it conducting a comprehensive assessment of environmental compliance? If the EPA is focusing on a specific environmental statute, is it focusing on all areas of compliance monitoring under the statute, or is it focusing on a particular enforcement priority like resource conservation? Answering these types of questions will be critical for efficiently implementing an informed defense strategy.

3. Locate All Relevant Compliance Documentation 

Once you know what the EPA will be looking for, the next step is determining what it is going to find when they request information. This begins with locating all of the company’s relevant compliance documentation. This will facilitate conducting an internal EPA compliance assessment (more on this below), and it will also allow the company to efficiently respond to document requests and other inquiries during the inspection process.

4. Conduct an Internal EPA Compliance Assessment (if There is Time)

If there is time, it will be important to conduct an internal EPA compliance assessment, like a mock audit, before the EPA’s inspection begins—unless the company has recently completed a systematic environmental compliance audit in compliance with the relevant EPA Audit Protocols. There is incentive for self-policing which incentivizes you to voluntarily discover and fix violations. If there is not time to conduct an internal assessment before the inspection begins, then this should be undertaken in parallel with the company’s inspection defense, with a focus on accurately assessing the risks associated with the inspection as quickly as possible.

5. Put Together Your EPA Inspection Defense Strategy and Team 

Effectively responding to an EPA inspection requires an informed defense strategy and a capable team. A company’s EPA inspection defense team should include appropriate company leaders and internal subject matter experts as well as the company’s outside EPA compliance counsel.

What to Do During an EPA Inspection

Here are some important steps to take once an EPA inspection is underway:

1. Proactively Engage with the EPA’s Inspectors and Technical Personnel 

Companies facing EPA inspections should not take a back seat during the process. Instead, they should seek to proactively engage with the EPA’s inspectors and technical personnel (through their EPA compliance counsel) so that they remain fully up to speed and can address any potential issues or concerns as quickly as possible.

2. Use the Company’s EPA Compliance Documentation to Guide the Process 

For companies that have a strong compliance record and clear documentation of compliance, using this documentation to guide the inspection process can help steer it toward an efficient and favorable resolution.

3. Carefully Assess Any Concerns About Non-Compliance 

If any concerns about non-compliance arise during the EPA inspection process, company leaders should work with the company’s EPA compliance counsel to assess these concerns and determine how best to respond.

4. Work with the EPA’s Inspectors and Technical Personnel to Resolve Compliance Concerns as Warranted 

If any of the EPA’s concerns about non-compliance are substantiated, companies should work with the EPA’s inspectors and technical personnel (through their EPA compliance counsel) to resolve these concerns as efficiently as possible—and ideally during the inspection process so that no follow-up interactions with the EPA are necessary.

5. Focus on Achieving a Final Resolution that Avoids Further Inquiry

Overall, the primary focus of a company’s EPA inspection defense should be on achieving a final resolution that avoids further inquiry. Not only can post-inspection civil investigations present substantial risks, but unresolved compliance concerns can leave companies (and their owners and executives) exposed to the possibility of criminal prosecution in some cases as well.

What to Do After an EPA Inspection 

Finally, here are some key considerations for what to do after an EPA inspection:

1. Complete Any Necessary Follow-Up as Efficiently as Possible 

If any follow-up corrective or remedial action is necessary following an EPA inspection, the company should prioritize completing this follow-up as efficiently as possible. Not only will this help to mitigate any penalty exposure, but it will also help mitigate the risk of raising additional concerns with the EPA.

2. Implement Any Lessons Learned 

If the EPA’s inspection resulted in any lessons learned, the company should also prioritize implementing these lessons learned in order to prevent the recurrence of any issues uncovered during the inspection process. This is true whether implementation involves making minor tweaks to the company’s documentation procedures or completing a substantial overhaul of the company’s environmental compliance program.

3. Use Systematic EPA Compliance Audits to Evaluate and Maintain Compliance 

Systematic auditing is one of the most efficient and most effective ways that companies can evaluate and maintain EPA compliance. For companies that are not using the EPA’s Audit Protocols already, working with experienced outside counsel to implement these protocols will be a key next step as well.

4. Challenge Any Unwarranted Conclusions as Warranted 

If the company’s EPA inspection resulted in unwarranted determinations of non-compliance, seeking to reverse the agency’s conclusions may involve working with its lawyers post-inspection. Depending on the circumstances, it may also involve going to court. Whatever it takes, ensuring that the company does not face unjustified penalties will be essential for both short-term and long-term environmental compliance risk management.

5. Prepare for Further Enforcement Action as Necessary 

If an EPA inspection results in substantial findings of non-compliance, it may be necessary to prepare for further enforcement action. Depending on the circumstances, this could involve facing a civil investigation, a criminal investigation conducted jointly by the EPA and the U.S. Department of Justice (DOJ), or litigation in federal court. Here, too, an informed and strategic defense is essential, and it will be critical to continue working with experienced EPA compliance counsel throughout this process.

Oberheiden P.C. © 2024
For more news on EPA Site Inspections, visit the NLR Environmental, Energy, & Resources section.

EPA Announces Strengthening the Safer Choice and Design for the Environment Standard for Commercial and Household Cleaning Products

On August 8, 2024, the U.S. Environmental Protection Agency announced that it made updates to strengthen the Safer Choice and Design for the Environment (DfE) Standard, which identifies the requirements that products and their ingredients must meet to earn EPA’s Safer Choice label or DfE logo. EPA states these updates strengthen the criteria that products must meet to qualify for the voluntary Safer Choice label, supporting the use of safer chemicals in the marketplace.

According to EPA, the Safer Choice program was implemented so consumers and purchasers for facilities like schools and office buildings could find cleaners, detergents, and other products made with safer chemical ingredients. It encourages use of chemicals that meet EPA’s stringent criteria for human health and the environment and provides opportunities for companies to differentiate their products in the marketplace with the Safer Choice label.

Similarly, the DfE program assists consumers to find antimicrobial products that meet high standards for public health and the environment. It assists consumers to identify antimicrobial products like disinfectants that meet the health and safety standards of the normal pesticide registration process required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as well as meeting the Safer Choice and DfE Standard.

In addition to updated clarifying language, the final updated Standard includes:

  • A new certification program for cleaning service providers that use Safer Choice- and DfE-certified products. The Cleaning Service Certification logo is available for organizations and businesses that use cleaners, detergents, disinfectants, and related products as part of their primary operations. The logo distinguishes cleaning service providers who use Safer Choice-certified products for cleaning and DfE-certified products for disinfection either exclusively or to the maximum extent practicable.
  • Strengthened criteria that pet care products must meet to ensure they use only the safest possible ingredients for humans, pets, and the environment.
  • Updated safer packaging criteria, ensuring primary packaging does not include any unintentionally added per- and polyfluoroalkyl substances (PFAS) or other chemicals of concern.
  • Strengthened sustainable packaging requirements for all Safer Choice-certified products to use post-consumer recycled content and be recyclable or reusable.
  • Updated criteria for wipe products to ensure certified wipes contain “Do Not Flush” language to help reduce damage to wastewater treatment systems.
  • New, optional energy efficiency or use reduction criteria to encourage companies to use less water, use renewable energy, and improve energy efficiency.

This update follows a November 2023 request for public comment on EPA’s proposed updates to the Standard. This is EPA’s fourth update of the Standard since its inception in 2009 and the first since 2015. EPA states it periodically updates the Standard to keep current with the state of scientific and technological innovation, increase transparency and reduce redundancy, and expand the scope of the program as appropriate.

The updated Standard is available here.

©2024 Bergeson & Campbell, P.C.
by: Heather F. Collins, Barbara A. Christianson of Bergeson & Campbell, P.C.

Environmental Compliance in 2024: What Does it Take to Avoid Triggering EPA Scrutiny?

As environmental concerns continue to take center stage, more and more companies are finding themselves facing scrutiny from the U.S. Environmental Protection Agency (EPA). As a result, from a risk management perspective, environmental compliance is more important than ever in 2024—and this is likely to remain the case for the foreseeable future.

What does this mean for companies whose operations have (or have the potential to have) environmental impacts? The short answer is that they need to make EPA compliance a priority. They must proactively address all areas of concern, and they must be prepared to demonstrate their proactive efforts to the EPA if necessary.

The EPA’s enforcement arm is extremely active, and several offices within the agency are tasked with uncovering and addressing environmental regulations violations. As discussed below, many federal environmental laws include criminal enforcement provisions as well, and the EPA regularly works with the U.S. Department of Justice (DOJ) to pursue criminal charges when warranted.

7 Keys to Avoiding EPA Scrutiny in 2024 (and Beyond)

With all of this in mind, what do company owners and executives need to know in order to avoid triggering EPA scrutiny in 2024 (and beyond)? Here are seven tips for effectively manage environmental compliance in today’s world:

1. Thoroughly Assess the Company’s Environmental Compliance Obligations

The EPA enforces numerous federal environmental statutes, and it has promulgated an extraordinarily long, dense, and complicated set of regulations under these statutes. The EPA enforces a number of environmentally focused Executive Orders (EOs) as well. As a result, for all companies, the first step toward implementing an effective EPA compliance program is determining which laws, regulations, and EOs apply. Here are just some of the most common examples:

  • Clean Air Act (CAA) compliance
  • Clean Water Act (CWA) compliance
  • Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) compliance
  • Endangered Species Act (ESA) compliance
  • Energy Independence and Security Act (EISA) compliance
  • Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) compliance
  • Food Quality Protection Act (FQPA) compliance
  • Marine Protection, Research, and Sanctuaries Act (MPRSA) compliance
  • Resource Conservation Recovery Act (RCRA) compliance
  • Safe Drinking Water Act (SDWA) compliance
  • Toxic Substances Control Act (TSCA) compliance
  • Environmental Executive Order (EO) compliance

Determining applicability requires an in-depth understanding of each source of authority’s focus and scope. As a result, assessing a company’s environmental compliance obligations generally involves engaging experienced outside EPA counsel.

2. Develop Custom-Tailored Environmental Compliance Policies, Procedures, and Protocols

Of course, simply understanding a company’s compliance obligations is not enough. To effectively manage environmental compliance, companies must develop environmental compliance policies, procedures, and protocols that are custom-tailored to their operations and facilities. These should be sustainable practices that will increase operational efficiency and reduce costs and waste.

This, too, involves working with experienced EPA counsel. To establish and maintain EPA compliance, companies may need to take a variety of different steps. Depending on the specific environmental risks a company’s operations present (or may present), these steps may include:

  • Applying for a license, permit, or registration with the EPA
  • Passing EPA inspections
  • Restricting or preventing the discharge of contaminants or pollutants
  • Issuing notifications to consumers and/or the EPA
  • Promptly remediating spills and other exposure events

These are just a handful of numerous possibilities. While managing EPA compliance will be relatively straightforward for some companies, for others it can be a substantial undertaking. In both cases, developing custom-tailored policies, procedures, and protocols is a critical step toward effective regulatory compliance management.

3. Prioritize Environmental Compliance as an Element of Corporate Culture and Responsibility

Managing EPA compliance is not a one-time event. In other words, while developing custom-tailored policies, procedures, and protocols is a critical step toward effective compliance management, it is ultimately just one step in an ongoing process.

To effectively manage EPA compliance, companies need to take a top-down approach. They need to prioritize environmental compliance as an element of corporate culture and responsibility, and they need to make clear that personnel at all levels of the organization play an important role in protecting both the environment and the company. Lack of understanding and commitment at the executive level is a red flag for the EPA, and ineffective implementation of a company’s EPA compliance program can significantly increase its risk of both committing violations and facing enforcement.

4. Monitor and Audit Environmental Compliance

Another critical aspect of effectively managing a company’s environmental compliance-related risk is internally assessing compliance on an ongoing basis. Once a company has implemented its custom-tailored policies, procedures, and protocols, it must determine whether these are functioning as intended. While they should be, companies cannot afford to assume that this is the case. Ineffective training, oversights during implementation, changes in a company’s operational procedures, and various other issues can lead to compliance failures despite the implementation of an otherwise well-suited EPA compliance program.

Internally assessing compliance has two main components: (i) continuous monitoring, and (ii) periodic auditing. Companies should have safeguards in place that are designed to detect material violations when they occur. Companies must also conduct compliance audits at least annually to perform a deep-dive analysis of the efficacy of their compliance efforts. Crucially, if a company’s monitoring or auditing efforts uncover a violation of environmental rules, the company must then respond appropriately—and it must do so as efficiently as possible.

5. Generate and Store Environmental Compliance Documentation as a Matter of Course

When facing scrutiny from the EPA, being prepared to affirmatively demonstrate a company’s good-faith environmental compliance efforts is essential. In almost all cases, this is both the most effective and the most efficient way to resolve an EPA inquiry. Doing so requires clear and comprehensive documentation of the company’s ongoing compliance efforts, including its efforts to monitor, audit, and enforce compliance.

This means that companies need to generate and store environmental compliance documentation as a matter of course. By building documentation into their procedures and protocols, companies can do this efficiently and in a manner that facilitates demonstrating compliance to the EPA when necessary.

6. Respond Promptly (and Appropriately) to Information Requests and Other Inquiries

Companies can hear from the EPA under a variety of different circumstances. While different types of inquiries call for different types of responses, in all cases, a prompt and informed response is critical.

Once the EPA initiates an inquiry, it isn’t simply going to go away. Delay tactics will raise red flags; and, in the meantime, the EPA will be continuing its investigative and enforcement efforts. As part of their EPA compliance policies and procedures, companies should establish a step-by-step process for responding to the EPA in various scenarios. In most scenarios, the first step in this process will be engaging the company’s outside EPA counsel to provide guidance.

7. Update the Company’s Environmental Compliance Program as Necessary

Just as companies need to monitor their EPA compliance efforts on an ongoing basis, they must also monitor for any changes that necessitate updates to their environmental compliance programs. These changes could involve either: (i) changes in the environmental legislation; or, (ii) changes in the company’s operations that present new environmental compliance risks. In both cases, prompt action is key, as the EPA expects companies to consistently maintain comprehensive compliance.

Failing to Effectively Address Environmental Compliance: What Are the Risks?

Ideally, companies will maintain effective EPA compliance programs, and this means that they won’t have to worry about the risks of noncompliance. But, let’s say a company doesn’t do everything that is required. If the EPA has grounds to pursue enforcement, what are the risks involved?

Depending on the circumstances, the risks of environmental noncompliance can include:

  • Loss of License, Permit, or Registration – Companies may need to obtain a license, permit, or registration from the EPA in various scenarios. Failure to comply with the terms of licensure, permitting, or registration can lead to temporary suspension or permanent revocation.
  • “No Sale” Orders, Injunctions, and Other Administrative Remedies – The EPA also has the authority to impose “no sale” orders, injunctions, and other administrative remedies as necessary. If a company’s products or operations pose immediate environmental risks, the EPA can—and will—step in to intervene.
  • Civil Monetary Penalties – Environmental noncompliance can also trigger civil monetary penalties in many cases. Under several statutes, these penalties accrue on a daily or per-violation basis, which can lead to substantial financial liability for companies of all sizes.
  • Criminal Fines – As noted above, many of the statutes within the EPA’s enforcement jurisdiction include provisions for criminal enforcement. In criminal enforcement cases, companies can face substantial fines—and, in the aggregate, these fines can easily total millions, if not tens or hundreds of millions, of dollars.
  • Federal Imprisonment for Owners, Executives, and Others – Criminal enforcement cases can also expose companies’ owners, executives, and others to the risk of federal imprisonment. While relatively rare, the EPA and DOJ do not hesitate to pursue incarceration of implicated individuals when warranted.
Oberheiden P.C. © 2024
For more news on Environmental Compliance in 2024, visit the NLR Environmental Energy Resources section.

PFAS CERCLA Expansion Now On Hold

We have regularly reported on the EPA‘s long-anticipated  rule to designate PFOA and PFOS as “hazardous substances” under CERCLA. In April 2024, the EPA also issued an Advanced Notice of Proposed Rulemaking (ANPRM), which aimed to have seven additional PFAS added to the CERCLA list of “hazardous substances.” EPA originally set a deadline of April 2025 to finalize the rule to add seven additional PFAS to CERCLA; however, EPA’s July 2024 Unified Agenda now indicates that the deadline to finalize the rule for the additional seven PFAS is “to be determined.”

The shift in priorities away from an expanded PFAS CERCLA designation is a significant development that anyone follows PFAS regulatory or litigation news.

CERCLA PFAS Scope Designation To Date

On January 10, 2022, the EPA submitted a plan for a PFAS Superfund designation to the White House Office of Management and Budget (OMB) when it indicated an intent to designate two legacy PFAS – PFOA and PFOS – as “hazardous substances” under the Comprehensive Environmental Response, Compensation & Liability Act (CERCLA, also known as the Superfund law). The EPA previously stated its intent to make the proposed designation by March 2022 when it introduced its PFAS Roadmap in October 2021. Under the Roadmap, the EPA planned to issue its proposed CERCLA designation in the spring of 2022. On August 12, 2022, a CERCLA PFAS designation took a significant step forward when the OMB approved the EPA’s plan for PFOA and PFOS designation. This step opened the door for the EPA to put forth its proposed designation of PFOA and PFOS under CERCLA and engage in the required public comment period.

When OMB initially contemplated approving the EPA’s proposed rule, it designated the rule as “other significant”, which meant that the rule was predicted to have costs or benefits less than $100 million annually. However, the OMB received several pieces of feedback expressing concern that such an estimate fa undervalued the impact that such a designation will have. More specifically, the Chamber of Commerce provided its own estimate that the CERCLA designation would have a cost impact of over $700 million annually. As a result, the OMB changed its designation of the EPA’s propose rule to “economically significant”, which triggered the EPA to have to conduct a RIA prior to proposing the PFAS CERCLA designation. Under the RIA, the EPA will have to provide support for its position that a CERCLA designation is justified to achieve EPA goals and to provide support for the contention that such a designation is the least burdensome and most cost-effective way to achieve the EPA’s goals.

Despite the call for a RIA by the OMB, the EPA nevertheless released its final CERCLA designation in May 2024, the significance of which, if it survives legal challenges, will be felt for some time.

Additional CERCLA Designation

In February 2023, the EPA sent a proposed rule to the OMB that states the following:

“EPA plans to publish in the Federal Register an advance notice of proposed rulemaking requesting public input on whether the agency should consider designating as hazardous substances precursors to PFOA and PFOS, whether the agency should consider designating other PFAS as CERCLA hazardous substances and whether there is information that would allow the agency to designate PFAS as a class or subclass.”

The OMB reviewed the proposal and on March 24, 2023, approved the proposal so as to permit the EPA to proceed with publishing the Advanced Notice of Proposed Rulemaking (ANPRM).

On April 13, 2023, the EPA published in the Federal Register an ANPRM that seeks public comment on a proposal to list as “hazardous substances” the following additional PFAS: PFBS, PFHxS, PFNA, HFPO-DA, PFBA, PFHxA, and PFDA. The EPA indicated that the seven PFAS were chosen based on available toxicity data for the chemicals.

CERCLA PFAS Designation: Impact On Businesses

Once a substance is classified as a “hazardous substance” under CERCLA, the EPA can force parties that it deems to be polluters to either cleanup the polluted site or reimburse the EPA for the full remediation of the contaminated site. Without a PFAS Superfund designation, the EPA can merely attribute blame to parties that it feels contributed to the pollution, but it has no authority to force the parties to remediate or pay costs. The designation also triggers considerable reporting requirements for companies. Currently, those reporting requirements with respect to PFAS do not exist, but they would apply to industries well beyond just PFAS manufacturers. The CERCLA PFAS scope in any final regulation is therefore critical to numerous industries that were or are downstream users of PFAS.

The downstream effects of a PFOA and PFOS designation would be massive, but a designation of the entire class of PFAS or even various subclasses of PFAS would be potentially unquantifiable in financial magnitude. With over 15,000 PFAS in existence according to the EPA and many of them in continued use to this day, the potential environmental pollution ramifications touch on countless industry types. Companies that utilized PFAS in their industrial or manufacturing processes and sent the PFAS waste to landfills or otherwise discharged the chemicals into the environment will be at immediate risk for enforcement action by the EPA given the EPA’s stated intent to hold all PFAS polluters of any kind accountable. Waste management companies should be especially concerned given the large swaths of land that are utilized for landfills and the likely PFAS pollution that can be found in most landfills due to the chemicals’ prevalence in consumer goods. These site owners may be the first targeted when the PFOA/PFOS designation is made, which will lead to lawsuits filed against any company that sent waste to the landfills for contribution to the cost of cleanup that the waste management company or its insured will bear. However, with a broader PFAS designation a possibility now, there should naturally be concern regarding re-openers in the future for these same sites.

Of course, all of the above are subject now to legal challenges of the final CERCLA designation, which will play out over the next several months. In addition, EPA (and the rest of the country) are now living in a post-Chevron world, which is sure to have significant impacts on challenges to EPA’s intentions with respect to PFAS under CERCLA. It is perhaps for these reasons that EPA recently adjusted its deadline to finalize the expended PFAS CERCLA designation to a status of “to be determined.” This is quite significant and shows to me that EPA is adjusting its resources to prepare for the legal challenges to come, as well as focusing more earnestly on initiatives that it can pass prior to a potential shift in party power in the November 2024 elections.

Conclusion

While it is likely fair to say that almost all significant PFAS initiatives that EPA wishes to undertake will not be pushed forward until after the November election cycle, it is nevertheless of great importance for companies, insurers, and financial world specialists to continue to monitor PFAS developments. Even with a party shift in November, PFAS is unlikely to be wiped off of the map, so to speak, in terms of an environmental issue. The awareness of PFAS issues among media, politicians and citizens is simply too great at this point. In addition, developments that will be critical to monitor because of the impact that they may have on PFAS litigation, which will surely subsume PFAS regulatory impacts if November brings a party power shift.

©2024 CMBG3 Law, LLC. All rights reserved.
For more news on PFAS CERCLA Expansion, visit the NLR Environmental Energy Resources section.

Recent Federal Developments, July 2024

TSCA/FIFRA/TRI

EPA’s Proposed NMP Risk Management Rule Includes Requirements To Protect Workers And Consumers: On June 15, 2024, the U.S. Environmental Protection Agency (EPA) issued a proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) that would protect workers and consumers from exposure to N-methylpyrrolidone (NMP). 89 Fed. Reg. 51134. To address the identified unreasonable risk, EPA proposes to: prohibit the manufacture (including import), processing, distribution in commerce, and use of NMP in several occupational conditions of use (COU); require worker protections through an NMP workplace chemical protection program (WCPP) or prescriptive controls (including concentration limits) for most of the occupational COUs; require concentration limits on a consumer product; regulate certain consumer products to prevent commercial use; and establish recordkeeping, labeling, and downstream notification requirements. Comments are due July 29, 2024. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of the comments on or before July 15, 2024. According to EPA’s June 5, 2024, press release, NMP is used to manufacture and produce many electronics, polymers, agricultural chemicals, and petrochemical products. EPA states that NMP is used in the production of specialized electronics, such as semiconductors and magnet wire, as well as lithium-ion batteries used in a wide variety of applications, including aerospace vehicles and electronic devices. EPA notes that NMP “also has numerous other industrial, commercial and consumer applications, including adhesives and sealants, paints and coatings, paint removers, lubricants, automotive care products, degreasers, cleaning and furniture care products.” For more information, please read the full memorandum.

EPA Announces Final Cancellation Order And Updates To Existing Stocks Provisions For Several Chlorpyrifos Products: On June 25, 2024, EPA announced the issuance of a final cancellation order for Corteva’s chlorpyrifos product “Dursban 50W in Water Soluble Packets” and three Gharda chlorpyrifos products, and an amendment to the existing stocks provisions for two Liberty and three Winfield chlorpyrifos end-use products. EPA also states that it has updated its frequently asked questions about chlorpyrifos. More information is available in our July 2, 2024, blog.

EPA Announces New Initiatives To Improve Efficiency, Worker Protections, And Transparency In New Chemical Reviews: During the June 26, 2024, “TSCA Reform — Eight Years Later” conference, presented by Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health, Michal Ilana Freedhoff, Ph.D., Assistant Administrator, Office of Chemical Safety and Pollution Prevention, EPA, provided the keynote address. During her remarks, Freedhoff announced four new initiatives in EPA’s review of new chemicals under TSCA. As later announced by EPA, these initiatives are:

  • Engineering checklist: In May 2024, EPA began implementing an internal engineering checklist to review systematically new chemical submissions and identify potential data gaps at the beginning of the review process.
  • Worker protections: According to EPA, most TSCA Section 5(e) orders are consent orders negotiated between EPA and the notice submitter that use standard “boilerplate” text. In June 2024, EPA updated the boilerplate language to strengthen worker protections and provide further clarity to the text.
  • Updated statistics for new chemical review timelines: On June 26, 2024, EPA began including completed “rework” risk assessments when reporting monthly statistics on new chemical reviews. EPA has updated its Statistics for the New Chemicals Program under TSCA web page to include a category listing all completed rework risk assessments since the beginning of 2024.
  • Reference Library: On June 26, 2024, EPA launched the New Chemicals Division Reference Library, an index of EPA documents related to the work of the New Chemicals Division. It currently contains over 90 entries, and EPA will update it as it develops new materials.

More information is available in our June 26, 2024, blog item. A summary of the conference is available in our July 9, 2024, memorandum.

EPA Postpones Proposed Expansion Of The Safer Choice And DfE Programs: As reported in our July 27, 2023, memorandum, in July 2023, EPA proposed an expansion of the Safer Choice and Design for the Environment (DfE) programs to include certification of additional product categories. According to EPA’s website, “EPA thanks the many commenters for their input. EPA reviewed the comments and understands several categories are of interest to stakeholders and Safer Choice partners. With the 2024 decrease in EPA’s funding, however, EPA is not able to pursue expansion at this time. EPA plans to reconsider the expansion in the future as resources allow.” On June 28, 2024, a summary of comments received on EPA’s proposed expansion was posted in the online docket. More information is available in our July 5, 2024, blog item.

EPA Releases Draft Risk Evaluation For 1,1-Dichloroethane And Draft Hazard Assessment Of 1,2-Dichloroethane For Public Comment And Peer Review: On July 1, 2024, EPA announced the release of the draft risk evaluation for 1,1-dichloroethane and the draft human health hazard assessment supporting the draft risk evaluation for 1,2-dichloroethane (also known as ethylene dichloride) prepared under TSCA. EPA states that it “preliminarily determined 1,1-dichloroethane poses unreasonable risk to human health (of workers) and the environment.” According to EPA, the effects to people from exposure to 1,1-dichloroethane and 1,2-dichlorethane are “kidney and other cancers, as well as harmful non-cancer renal, nasal, immune system, and reproductive effects.” Publication of a notice of availability in the Federal Register will begin a 60-day comment period. More information will be available in a forthcoming memorandum.

Court Vacates TSCA Section 4 Test Order, Grant’s Vinyl Institute’s Petition For Review: On July 5, 2024, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision in Vinyl Institute, Inc. v. EPA (No. 22-1089). As reported in our May 31, 2022, blog item, on May 23, 2022, the Vinyl Institute, Inc. (VI) filed suit against EPA, seeking review of EPA’s March 2022 test order for 1,1,2-trichloroethane issued under TSCA Section 4(a)(2). The court states that “EPA’s non-public part of the administrative record is not part of ‘the record taken as a whole’ subject to our heightened substantial evidence review of TSCA test orders.” According to the court, to the extent EPA relies on non-public portions of the administrative record, it “has failed to provide substantial evidence that meets its statutory mandate.” The court vacated the test order, remanding to EPA to satisfy that mandate with “substantial evidence in the record taken as a whole.” The court also denied VI’s motion to supplement the record “with scientific information it could have — and should have — submitted earlier.” More information is available in our July 10, 2024, blog item.

EPA Publishes Compliance Guide For Final Methylene Chloride Risk Management Rule: On July 10, 2024, EPA published a compliance guide for its final methylene chloride risk management rule issued under TSCA. According to EPA, the compliance guide will help industry, workers, and other interested stakeholders understand and comply with the new regulations to prevent injuries, long-term illnesses, and deaths. EPA also announced that in June 2024, it released a fact sheet on the rule containing information on who is subject to the rule along with a summary of compliance timelines. More information will be available in a forthcoming memorandum.

EPA Grants TSCA Section 21 Petition Seeking Section 6 Rule Prohibiting Three PFAS Found In Fluorinated Plastic Containers: EPA announced on July 11, 2024, that it granted a petition filed a petition under TSCA Section 21 requesting that EPA establish regulations under TSCA Section 6 prohibiting the manufacturing, processing, use, distribution in commerce, and disposal of three per- and polyfluoroalkyl substances (PFAS) formed during the fluorination of plastic containers. EPA “will promptly commence an appropriate proceeding under TSCA Section 6.” According to EPA’s announcement, EPA intends to request information, including the number, location, and uses of fluorinated containers in the United States; alternatives to the fluorination process that generates perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA); and measures to address risk from PFOA, PFNA, and PFDA formed during the fluorination of plastic containers. More information will be available in a forthcoming memorandum.

EPA’s Spring 2024 Unified Agenda Includes Proposed And Final TSCA, TRI, And PFAS Rules: EPA’s Spring 2024 Unified Agenda, published on July 5, 2024, includes a number of proposed and final TSCA, Toxics Release Inventory (TRI), and PFAS rulemakings. More information on the rulemakings, including links to our memoranda, will be available in an upcoming blog item.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Publishes 2024-2027 Climate Adaptation Plan: EPA announced on June 20, 2024, the release of its 2024-2027 Climate Adaptation Plan, which describes Agency actions to address the impacts of climate change and help build a more climate-resilient nation. Highlights include:

  • Fostering a climate-ready workforce;
  • Building facility resilience;
  • Developing climate-resilient supply chains;
  • Integrating climate resilience into external funding opportunities;
  • Applying climate data and tools to decision making; and
  • Integrating climate adaptation into rulemaking processes.

EPA Amends Standards And Practices For All Appropriate Inquiries: EPA issued a final rule on June 24, 2024, amending the “Standards and Practices for All Appropriate Inquiries” to reference a standard practice recently made available by ASTM International, “a widely recognized standards development organization.” 89 Fed. Reg. 52386. EPA states that it is amending the All Appropriate Inquiries Rule to reference ASTM International’s E2247-23 “Standard Practice for Environmental Site Assessments: Phase I Environmental Site Assessment Process for Forestland or Rural Property” and allow for its use to satisfy the requirements for conducting all appropriate inquiries under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). In addition, after one year, EPA will remove recognition of the previous version of that standard, ASTM E2247-16, as compliant with the All Appropriate Inquiries Rule. The final rule will be effective August 23, 2024.

EPA Proposes To Remove Affirmative Defense Provisions From Specified NSPS And NESHAP: On June 24, 2024, EPA proposed amendments to several New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAP) under the Clean Air Act (CAA). 89 Fed. Reg. 52425. Specifically, EPA proposes to remove the affirmative defense provisions associated with violation of emission standards due to malfunctions. According to EPA, it proposes to remove these provisions because they are inconsistent with a D.C. Circuit Court decision that vacated affirmative defense provisions in one of EPA’s CAA regulations, and because EPA finds that the reasoning in the decision applies equally to other CAA rules. Since the court decision, EPA has been removing affirmative defense provisions from CAA rules when they were otherwise revised or amended. EPA states that this action “proposes to remove the remaining affirmative defense provisions more efficiently.” Comments are due August 8, 2024.

PHMSA Amends HMR To Require Real-Time Train Consistent Information In Electronic Form: The Pipeline and Hazardous Materials Safety Administration (PHMSA) published a final rule on June 24, 2024, amending the Hazardous Materials Regulations (HMR) to require railroads that carry hazardous materials to generate in electronic form, maintain, and provide to first responders, emergency response officials, and law enforcement personnel certain information regarding hazardous materials in rail transportation to enhance emergency response and investigative efforts. 89 Fed. Reg. 52956. According to PHMSA, the amendments address a safety recommendation of the National Transportation Safety Board and statutory mandates in The Fixing America’s Surface Transportation Act, as amended by the Infrastructure, Investment, and Jobs Act, and complement existing regulatory requirements pertaining to the generation, maintenance, and provision of similar information in hard copy form, as well as other hazard communication requirements. The effective date of the final rule is July 24, 2024. The voluntary compliance date was June 24, 2024. The delayed compliance date for Class I Railroads is June 24, 2025, and for Class II and III Railroads is June 24, 2026.

EPA Proposes To Extend Compliance Date For Installation Of Certain Variable Refrigerant Flow Systems: On June 26, 2024, EPA proposed to amend a provision of the Technology Transitions regulations promulgated under the American Innovation and Manufacturing Act. 89 Fed. Reg. 53373. The proposed amendment would allow one additional year, until January 1, 2027, solely for the installation of new residential and light commercial air conditioning and heat pump variable refrigerant flow systems that are 65,000 British thermal units per hour or greater using components manufactured in the United States or imported prior to January 1, 2026. According to EPA, the existing January 1, 2026, compliance date for the installation of certain variable refrigerant flow systems “may result in significant stranded inventory that was intended for new construction. EPA is promulgating this action to mitigate the potential for significant stranded inventory in this subsector.” Comments are due July 26, 2024.

PHMSA Requests Feedback On De Minimis Quantities Of Explosives: PHMSA published a request for information (RFI) on June 28, 2024, to solicit information from hazardous materials (HAZMAT) shippers pertaining to what small quantities or low concentrations of explosives they offer for transport appear to present a low risk to life, property, and the environment. 89 Fed. Reg. 54157. PHMSA seeks to determine what small quantities or low concentrations of explosives HAZMAT shippers offer for transport that appear to present a low risk (e.g., negligible severity, remote probability) to life, property, and the environment. PHMSA will use the information to define the focus of a research project investigating the risk of small and/or de minimis quantities of explosive substances and in selecting test samples for PHMSA research and development Contract# 693JK322C00003. Comments are due September 26, 2024. PHMSA states that it will consider comments received after that date to the extent possible.

EPA Determines Current NESHAP For PQBS Source Category Provides “Ample Margin Of Safety”: On July 5, 2024, EPA published a final rule regarding the residual risk and technology review conducted for the NESHAP for the Coke Ovens: Pushing, Quenching, and Battery Stacks (PQBS) source category and the periodic technology review for the Coke Oven Batteries (COB) source category NESHAP. 89 Fed. Reg. 55684. EPA states that it is issuing a final determination that risks due to emissions of hazardous air pollutants (HAP) from the PQBS source category are acceptable and that “the current NESHAP provides an ample margin of safety to protect public health.” The final rule was effective July 5, 2024, except for amendatory instruction 3, which was effective July 15, 2024. The incorporation by reference (IBR) of certain publications listed in the rule is approved by the Director of the Federal Register beginning July 5, 2024. The IBR of certain other material listed in the rule was approved by the Director of the Federal Register as of July 13, 2005.

EPA Releases Science-Based Recommendations To Help Reduce Exposure To Contaminants, Including PFAS, In Fish: EPA announced on July 11, 2024, that it issued updated recommendations under the Clean Water Act (CWA) for contaminants that states, Tribes, and territories should consider monitoring in locally caught, freshwater fish. According to EPA, for the first time, it has added several PFAS to the contaminant list alongside lead, three cyanotoxins, a flame retardant, and amphetamine. With this announcement, EPA suggests that states, Tribes, and territories monitor for these contaminants. EPA notes that this update comes after reviewing scientific literature, analyzing data, and seeking external peer review of the Agency’s analysis, and it will help ensure that state and Tribal fish advisories consider the latest science.

FDA

FDA Updates Resources For FSMA Rule: On June 27, 2024, the U.S. Food and Drug Administration (FDA) released additional resources to help industry comply with the Food Traceability Rule, a component of the Food Safety Modernization Act (FSMA). Resources include a template spreadsheet to help fulfill data submission requests and minor revisions to the Food Traceability List. Additional information is available at the link here.

FDA Releases Update For Priority Guidance Topic List: On June 28, 2024, FDA provided an update for its priority guidance topic list, which was released in January. Since January, FDA has issued the following guidance documents:

FDA notes that its “intent is to publish all draft and final guidance topics on the list” but that “modifications in plans may be needed to support emerging issues and Administration priorities.”

FDA Revokes Authorization For Brominated Vegetable Oil: On July 3, 2024, FDA amended its regulations to revoke the authorization for the use of brominated vegetable oil (BVO) in food. 89 Fed. Reg. 55040. The final rule revokes the authorization for the use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages. FDA notes that there are no other FDA authorized uses. The rule is effective on August 2, 2024.

NANOTECHNOLOGY

ECHA Evaluating Function Of EUON; Survey Closed July 3, 2024: The European Chemicals Agency (ECHA) is evaluating the function of the European Union (EU) Observatory for Nanomaterials (EUON). As part of its evaluation, ECHA conducted a survey to collect responses from EUON website visitors and stakeholders. The survey closed July 3, 2024. More information is available in our June 24, 2024, blog item.

ECHA Updates Report On Key Areas Of Regulatory Challenge, Addresses Micro- And Nano-Sized Materials: On June 12, 2024, ECHA announced that it updated its report on key areas of regulatory challenge, providing more detailed information on areas where scientific research is needed to protect human health and the environment from hazardous chemicals. The report addresses micro- and nano-size materials. More information is available in our June 17, 2024, blog item.

NIOSH Highlights NTRC’s Work On Engineering Controls And PPE: On July 1, 2024, the National Institute for Occupational Safety and Health (NIOSH) posted a NIOSH Science Blog item entitled “Celebrating 20 Years of the Nanotechnology Research Center: Highlights from Engineering Controls and Personal Protective Equipment,” part of a series commemorating the 20th anniversary of the Nanotechnology Research Center (NTRC). NIOSH researchers plan to develop a new reliable aerosol testing method that can accurately evaluate the respirator penetration against workplace nanomaterials; evaluate the effectiveness of NIOSH-approved® respirators to determine whether existing respirator guidelines apply to workers exposed to nanomaterials; and compare nanomaterial penetrations determined by direct-reading and elemental carbon analysis methods. More information is available in our July 5, 2024, blog item.

NNI And NNCO Will Hold July 24 Workshop On “Responsible Development, Social Science, And The National Nanotechnology Initiative”: The National Nanotechnology Initiative (NNI) and the National Nanotechnology Coordination Office (NNCO) are convening a July 24, 2024, workshop, “Responsible Development, Social Science, and the National Nanotechnology Initiative: A Workshop to Explore Past and Future Intersections.” The agenda includes a presentation about the recently released “Blueprint for the Use of Social and Behavioral Science to Advance Evidence-Based Policymaking,” introductions to key nanotechnology case studies by federal experts, and flash talks by social scientists. More information is available in our July 3, 2024, blog item.

BIOBASED/RENEWABLE PRODUCTS/SUSTAINABILITY

B&C® Biobased And Sustainable Chemicals Blog: For access to a summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to https://www.lawbc.com/brand/bioblog/.

LEGISLATIVE

House Appropriations Committee Approves FY 2025 Interior, Environment, And Related Agencies Appropriations Act: The House Appropriations Committee announced on July 9, 2024, that it approved the Fiscal Year (FY) 2025 Interior, Environment, and Related Agencies Appropriations Act by a vote of 29 to 25. According to the press release, the bill:

  • Ensures chemical and pesticide manufacturers are not overburdened with requirements that would drive business overseas and threaten American competitiveness;
  • Blocks EPA’s car regulations on light, medium, and heavy-duty vehicles;
  • Prohibits EPA from allowing California to require that new small off-road engines, such as lawn care equipment, be zero-emission;
  • Prohibits funds for EPA’s Clean Power Plan 2.0 and regulatory overreach regarding ozone emissions and steam electric power plants;
  • Reduces funding for EPA by 20 percent;
  • Reduces funding for the Council on Environmental Quality to the authorized level of $1 million;
  • Rejects eight of the Administration’s climate change executive orders; and
  • Prohibits agencies from using the Social Cost of Carbon (SCC) in cost-benefit analyses and blocks the Interagency Working Group on Social Cost of Greenhouse Gases.

House Committee Holds EPA Oversight Hearing On July 10, 2024: The House Committee on Oversight and Accountability held a full committee hearing on July 10, 2024, on “Oversight of the U.S. Environmental Protection Agency.” The Committee’s July 3, 2024, press release quotes Committee Chair James Comer (R-KY) as stating: “We know the Biden Administration is overreaching its environmental protection authorities extensively, flouting the limits the Supreme Court set upon them two years ago in West Virginia v. EPA and adopting statutory interpretations that surely will not pass muster under the Court’s recent decision in Loper Bright Enterprises v. Raimondo. The Committee looks forward to holding the agency accountable next week for its efforts to cement Green New Deal and other misguided priorities that have hurt both American businesses and consumers across the country.” More information will be available in a forthcoming memorandum.

MISCELLANEOUS

California Court Grants Injunction To Stop Prop 65 Warnings For Titanium Dioxide In Cosmetic And Personal Care Products: On June 12, 2024, the U.S. District Court for the Eastern District of California (District Court) issued an Order granting a preliminary injunction brought by the Personal Care Products Council (PCPC), which alleged that the California Office of Environmental Health Hazard Assessment’s (OEHHA) requirement for warnings under Proposition 65 (Prop 65) related to titanium dioxide in cosmetics and personal care products violated the First Amendment. The Personal Care Products Council v. Bonta, No. 2:23-cv-01006-TLN-JDP (E.D. Cal. 2024). In its Order, the District Court enjoined the California Attorney General and any private citizen enforcers from enforcing Prop 65’s warning requirement for “cancer as applied to Listed Titanium Dioxide (i.e., titanium dioxide that consists of airborne, unbound particles of respirable size) in cosmetic and personal care products.” The District Court also denied a motion to intervene by Environmental Health Advocates, Inc. (EHA), who had argued it was “an interested party because it is the primary enforcer of Prop 65.” For more information, please read the full memorandum.

Proposition 65: OEHHA Proposes Additional Changes To “Short-Form” Warning Option: On June 14, 2024, the California OEHHA issued a notice proposing additional changes to its Prop 65 Article 6 “clear and reasonable warnings” regulations for “short-form” warnings (Notice). The changes proposed now are to the proposed regulations that OEHHA issued on October 27, 2023. The history of these amendments, dating back to January 2021, are set forth in our memorandum available here. Written comments on the proposed changes were due no later than June 28, 2024. More information is available in our July 5, 2024, memorandum.

June 2024 IRIS Program Outlook Released: EPA’s Health and Environmental Risk Assessment (HERA) Program announced on June 27, 2024, the release of the June 2024 Integrated Risk Information System (IRIS) Program Outlook. To maintain transparency, the IRIS Program provides an updated outlook of program activities. The IRIS Program Outlook describes assessments that are in development and projected public milestone dates.

Registration Opens For July Webinars On Minnesota’s PFAS In Products Law; MPCA Publishes Summary Of Comments On CUUs: The Minnesota Pollution Control Agency (MPCA) will hold two public webinars in July to provide updates and answer questions on Minnesota’s PFAS in products law (Amara’s Law), which takes effect in stages between 2025 and 2032:

  • Progress on rule development, July 18, 2024, 10:00 a.m. – 11:30 a.m. (CDT): Join MPCA staff for a presentation on preliminary rule writing for the PFAS in products reporting, fees, and currently unavoidable use (CUU) rules. Registration is open.
  • Information on 2025 prohibitions for retailers and manufacturers, July 25, 2024, 11:00 a.m. – 12:00 p.m. (CDT): This webinar will discuss how the 2025 PFAS in products prohibitions will affect retailers and manufacturers starting January 1, 2025, when 11 categories of consumer products must be free of intentionally added PFAS. Registration is open.

As reported in our January 12, 2024, blog item, MPCA published a request for comments (RFC) on planned new rules governing CUU determinations for products containing PFAS. According to the RFC, the main purpose of the rulemaking is to establish criteria and processes through which MPCA will make decisions on what uses of intentionally added PFAS will qualify as CUUs in products sold, offered for sale, or distributed in Minnesota. Any such determinations must be published by rule by MPCA by January 1, 2032. MPCA has posted a summary of the comments received on the RFC. More information is available in our June 24, 2024, blog item.

Minnesota Department Of Health Highlights Recent Publications On PFAS Bioaccumulation And PFAS In Infant Formula: The Minnesota Department of Health (MDH) recently noted that Health Risk Assessment scientists at MDH have published two articles in the Journal of Environmental Exposure Assessment related to PFAS:

OIRA Will Offer Training Sessions On Effective Participation In The Public Comment Process: As part of its efforts to strengthen public engagement in the federal regulatory process, the Office of Information and Regulatory Affairs (OIRA) in OMB announced on July 10, 2024, that it will offer training sessions on effective public participation in the public comment process. 89 Fed. Reg. 56777. In response to feedback received from the public and as part of its ongoing efforts to strengthen public participation in the regulatory process, OIRA will hold two training sessions on effective participation in the public comment process. During the training sessions, OIRA will describe opportunities to provide comment in the federal regulatory process; how to submit public comments; and how to draft effective public comments. The training sessions will be held on July 18, 2024, from 3:00 p.m. to 3:45 p.m. (EDT) and July 24, 2024, from 5:30 p.m. to 6:15 p.m. (EDT).

CISA Hosts 2024 Chemical Security Seminars On July 11 And 18, 2024: The U.S. Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA) is hosting the fully virtual 2024 Chemical Security Seminars on July 11 and July 18, 2024, from 10:00 a.m. – 3:00 p.m. (EDT). The sessions will cover a range of topics related to the security of dangerous chemicals. More information is available in our July 8, 2024, blog item.

Comments On Canada’s Updated Draft State Of PFAS Report And Revised Risk Management Scope Are Due September 11, 2024: The July 13, 2024, Canada Gazette includes a notice announcing the availability of the Updated Draft State of Per- and Polyfluoroalkyl Substances (PFAS) Report (Updated Draft Report) and Revised Risk Management Scope for Per- and Polyfluoroalkyl Substances (PFAS) (Revised Risk Management Scope). The Minister of the Environment and the Minister of Health (the ministers) propose to recommend that the class of PFAS, excluding fluoropolymers, be added to Part 2 of Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA). According to the Revised Risk Management Scope, Canada is considering:

  • As a first step, a regulatory instrument under CEPA to restrict PFAS not currently regulated in firefighting foams; and
  • Additional regulatory instrument(s) under CEPA to prohibit other uses or sectors in relation to PFAS. Prioritization for prohibition may be based on factors such as socioeconomic considerations, the availability of feasible alternatives, and the potential for human and environmental exposure.

The Revised Risk Management Scope states that “[v]oluntary risk management actions are also being considered to achieve early results to reduce releases of PFAS, as a complement to the proposed regulatory instruments.” Comments are due September 11, 2024. More information is available in our July 12, 2024, blog item.

©2024 Bergeson & Campbell, P.C.
For more news on Recent Federal Environmental Developments, visit the NLR Environmental Energy Resources section.