Tag: Environmental Protection Agency

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

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.

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.

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.

EPA, USDA, and FDA to Clarify Overlapping Biotechnology Regulatory Frameworks

On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and U.S. Food and Drug Administration (FDA) released a joint plan to identify areas of ambiguity, gaps, or uncertainty in their coordinated regulation of biotechnology products. Consistent with a directive issued by President Biden in September 2022, the agencies’ plan identifies specific issues that each has either recently addressed or will work to address to promote such products’ safe use.

Key Takeaways

  • What Happened: EPA, USDA, and FDA issued a joint plan for regulatory reform under their Coordinated Framework for the Regulation of Biotechnology.
  • Who’s Impacted: Developers of PIPs, modified mosquitos, biopesticides, and other biotechnology products under EPA’s jurisdiction.
  • What Should They Consider Doing in Response: Watch the three agencies’ regulatory dockets closely and consider submitting comments once new rules or draft guidance are published that may affect their products.

Background

President Biden’s executive order defined “biotechnology” as “technology that applies to or is enabled by life sciences innovation or product development.” Biotechnology products thus may include organisms (plants, animals, fungi, or microbes) developed through genetic engineering or manipulation, products derived from such organisms, and products produced via cell-free synthesis. These products may, in turn, be regulated under the overlapping statutory frameworks of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), Federal Food, Drugs and Cosmetics Act (FFDCA), Plant Pest Act (PPA), Federal Meat Inspection Act, Poultry Products Inspection Act, and more. Therefore, close coordination between EPA, USDA, and FDA is essential to ensure effective and efficient regulation of biotechnology products.

EPA Sets Sights on PIPs, Mosquitos, and Biopesticide Products

The agencies’ newly released plan identifies five biotechnology product categories where regulatory clarification or simplification are warranted: (1) modified plants; (2) modified animals; (3) modified microorganisms; (4) human drugs, biologics, and medical devices; and (5) cross-cutting issues. Under the new plan, EPA is engaged in all but the fourth category above.

For example, EPA has already taken steps to clarify its regulation of modified plant products, such as exempting from regulation under FIFRA and FFDCA certain plant-incorporated protectants (PIPs) created in plants using newer technologies. EPA next plans to address the scope of plant regulator PIPs and update its 2007 guidance on small-scale field testing of PIPs to reflect technological developments and harmonize with USDA containment measures.

Regarding modified animal products, EPA intends to work with USDA and FDA to coordinate and provide updated information on the regulation of modified insect and invertebrate pests. Specifically, EPA intends to provide efficacy testing guidance on genetically modified mosquitos intended for population control. As outlined in guidance published by FDA in October 2017, products intended to reduce the population of mosquitoes by killing them or interfering with their growth or development are considered “pesticides” subject to regulation by EPA, while products intended to reduce the virus/pathogen load within mosquitoes or prevent mosquito-borne disease in humans or animals are considered “new animal drugs” subject to regulation by FDA.

EPA also now intends to prioritize its review of biopesticide applications, provide technical assistance to biopesticide developers, and collaborate with state pesticide regulators to help bring new biopesticide products to market more quickly.

Further, the three agencies are making efforts to collaborate with each other and with the regulated community. The agencies jointly released plain-language information on regulatory roles, responsibilities, and processes for biotechnology products in November 2023 and now intend to explore the development of a web portal that would direct developers to the appropriate agency or office overseeing their product’s development or regulatory status. The agencies also intend to develop a mechanism for a product developer to meet with all agencies at once early in a product’s development process to clarify the agencies’ respective jurisdictions and provide initial regulatory guidance; to update their joint information-sharing memorandum of understanding; and to formally update the Coordinated Framework for the Regulation of Biotechnology by the end of the year.

Biotechnology product developers should closely monitor EPA, USDA, and FDA’s progress on the actions described above, as well as other USDA- and FDA-specific regulatory moves. Developers should assess the regulatory barriers to their products’ entry to market, consider potential fixes, and be prepared to submit feedback as the agencies propose new rules or issue draft guidance for comment.

© 2024 Beveridge & Diamond PC
For more news on EPA, USDA, and FDA guidance, visit the NLR Administrative & Regulatory section.

U.S. EPA Finalizes Designation of Two PFAS Chemicals as Hazardous Substances Under CERCLA

On April 19, the U.S. Environmental Protection Agency (EPA) released its long-awaited final rule designating perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, as “hazardous substances” under Section 102(a) of the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA” or “Superfund”) (the “Final Rule”). The designation, which takes effect 60 days after the final rule is published in the Federal Register, will provide expanded investigation and remediation authority to EPA, will provide a powerful tool for private actions under CERCLA, and will trigger additional release reporting requirements. It will also expand enforcement authority in states that regulate CERCLA-designated hazardous substances.

Hazardous Substance Designation of PFOA and PFOS Has Broad Implications for Cleanups and CERCLA Liability

PFOA and PFOS are two specific chemical compounds within a broad group of thousands of manmade chemicals known as per- and polyfluoroalkyl substances (PFAS). EPA focused its regulatory efforts on these two PFAS; however, the vast majority of PFAS remain unregulated under CERCLA even after issuance of the Final Rule.

Designating PFOA and PFOS as hazardous substances triggers numerous requirements. The primary impact of the Final Rule is that it incorporates PFOS and PFOA into CERCLA’s strict, joint and several liability framework. This change grants EPA the power to investigate releases of PFOA and PFOS and compel potentially responsible parties (PRPs), including owners and operators of a property or facility, to remediate releases of PFOA and PFOS through the specific CERCLA enforcement provisions. PRPs also now have a clear private right of action under CERCLA to pursue cost recovery and contribution actions. Additionally, when the Final Rule becomes effective, facilities will be required to immediately report releases of PFOA and PFOS above their designated “reportable quantities,” (currently one pound within a 24-hour period), to the National Response Center and relevant state or tribal authorities.

Furthermore, many states include CERCLA hazardous substances under their cleanup statutes, meaning these states will now be able to require remediation of PFOA and PFOS under state law.

Listing PFOA and PFOS as “hazardous substances” under CERCLA does not make PFOA or PFOS contaminated waste a “hazardous waste” or a “hazardous constituent” under the Resource Conservation and Recovery Act. However, this designation does require the U.S. Department of Transportation to designate PFOA and PFOS as “hazardous materials” for purposes of transport under the Hazardous Materials Regulations.

While the PFOA and PFOS CERCLA Listing is Final, Questions Remain

As noted in our prior article on the proposed rule, EPA’s designation of PFOA and PFOS as “hazardous substances” leaves several questions unanswered.

  • How will EPA’s CERCLA enforcement discretion policy really play out in practice? 

    Concurrently with the publication of the Final Rule, EPA also released a PFAS Enforcement Discretion and Settlement Policy under CERCLA. This enforcement policy captures EPA’s current position that it does not intend to pursue PRPs under circumstances where “equitable factors” do not support doing so. Enumerated circumstances in the policy include so-called “passive receivers” of PFAS, including community water systems and publicly-owned treatment works, publicly-owned municipal solid waste landfills, publicly-owned airports and local fire departments, and farms where PFAS-containing biosolids are applied to the land. However, EPA’s enforcement policy—which is not binding upon the agency and is subject to change at any time—should be viewed with a healthy dose of skepticism among regulated industries, considering the sheer breadth of potential CERCLA liability for these substances, as well as continued Congressional proposals to codify exemptions for passive receivers within the CERCLA statute itself. Notably, the agency’s enforcement position does not in any way prevent private parties from initiating cost recovery or contribution actions under CERCLA.

  • How will regulated industries manage the costs of PFOA and PFOS cleanup?PFAS contamination can be wide-ranging due to several factors unique to the chemicals themselves. Further, unlike remediation technologies for other well-studied contaminants, existing remediation technologies for PFOA and PFOS are nascent at best and are expensive at a large scale. It is therefore often difficult to even estimate accurate cost ranges for PFOA and PFOS cleanups, but costs can easily run into the millions of dollars at complex sites. Although EPA has published interim guidance on PFOA and PFOS disposal methods, and the recently passed Infrastructure Investment and Jobs Act provides $3.5 billion over five years for Superfund cleanups, the methods and money may not go as far as planned if cleanup costs for PFOA and PFOS sites end up exponentially higher.
  • How will EPA handle potential PFOA and PFOS contamination at closed Superfund sites?In response to comments seeking clarification on whether designating PFOA and PFOS will lead to the reopening of closed Superfund sites, EPA stated that the final rule “has no impact” on EPA’s authority to list PFOA and PFOS sites as Superfund sites. EPA’s question-and-answers page—which we note is not a binding statement from the agency—also states that “[d]esignation will not change EPA’s process for listing and/or deleting [National Priorities List (NPL)] sites or evaluating remedies’ protectiveness through five-year reviews, and it will not require PFOA and PFOS sampling at NPL (final or deleted) sites.” While the final rule does not require PFOA and PFOS sampling at closed sites, it does not prevent EPA from ordering sampling at these sites. PRPs who may have long ago stopped budgeting for remedial costs at existing or legacy locations that were remediated years and even decades ago, may find that they are required to revisit these sites where PFOA and PFOS may be present.
  • What cleanup standards will govern PFOA and PFOS remediation?There is a current patchwork of state regulatory standards relating to PFAS, ranging from binding cleanup levels, advisory guidance, or no PFAS standards at all, which may lead to similarly patchwork cleanup standards depending on which standards are applied as an appropriate “applicable or relevant and appropriate requirement” (ARAR) at a specific site. In addition, on April 10, 2024, EPA issued a final rule setting Maximum Contaminant Levels (MCL) for PFOA and PFOS in drinking water at 4.0 parts per trillion (ppt), individually. While these drinking water standards are separate from EPA’s final rule listing PFOA and PFOS as “hazardous substances” under CERCLA, the “hazardous substances” rule notes that the MCL may be an appropriate ARAR for cleanup efforts under CERCLA.
  • What other PFAS will EPA next target under CERCLA?As noted above, PFOA and PFOS are two specific PFAS among thousands of others currently and historically used. Much of the science on the potential health effects of PFAS (both individual chemical compounds and as a class) continues to evolve. In the meantime, EPA has moved to regulate additional types of PFAS under other statutes. For example, as we noted in a previous client alert, EPA recently published a proposed rule listing seven other PFAS compounds as hazardous constituents under RCRA. Some or all of these PFAS may eventually be targets of future CERCLA rulemaking efforts.

Next Steps

The Final Rule will take effect 60 days after it is published in the Federal Register. Affected parties should consider their portfolio of planned, active, and in some cases, closed remediation sites for potential implications, and companies may consider reviewing and updating their hazardous substance reporting and transportation protocols to address PFOA and PFOS as applicable.

© 2024 Foley & Lardner LLP
For more on PFAS, visit the NLR Environmental, Energy & Resources section.

Global Regulatory Update for April 2024

WEBINAR – Registration Is Open For “Harmonizing TSCA Consent Orders with OSHA HCS 2012”: Register now to join The Acta Group (Acta®) and Bergeson & Campbell, P.C. (B&C®) for “Harmonizing TSCA Consent Orders with OSHA HCS 2012,” a complimentary webinar covering case studies and practical applications of merging the requirements for consent order language on the Safety Data Sheet (SDS). In this webinar, Karin F. Baron, MSPH, Director of Hazard Communication and International Registration Strategy, Acta, will explore two hypothetical examples and provide guidance on practical approaches to compliance. An industry perspective will be presented by Sara Glazier Frojen, Senior Product Steward, Hexion Inc., who will discuss the realities of managing this process day-to-day.

SAVE THE DATE – “TSCA Reform — 8 Years Later” On June 26, 2024: Save the date to join Acta affiliate B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health for a day-long conference reflecting on the challenges and accomplishments since the implementation of the 2016 Lautenberg Amendments and where the Toxic Substances Control Act (TSCA) stands today. This year, the conference will be held in person at the George Washington University Milken Institute School of Public Health (and will be livestreamed via YouTube). Continuing legal education (CLE) credit will be offered in select states for in-person attendees only. Please check ELI’s event page in the coming weeks for more information, including an agenda, CLE information, registration, and more. If you have questions in the meantime, please contact Madison Calhoun (calhoun@eli.org).

AUSTRALIA

Changes To Categorization, Reporting, And Recordkeeping Requirements For Industrial Chemicals Will Take Effect April 24, 2024: The Australian Industrial Chemicals Introduction Scheme (AICIS) announced regulatory changes to categorization, reporting, and recordkeeping requirements will start April 24, 2024. For the changes to take effect, the Industrial Chemicals (General) Rules 2019 (Rules) and Industrial Chemicals Categorisation Guidelines will be amended. According to AICIS, key changes to the Rules include:

  • Written undertakings replaced with records that will make compliance easier;
  • Greater acceptance of International Nomenclature of Cosmetic Ingredients (INCI) names for reporting and recordkeeping;
  • Changes to the categorization criteria to benefit:
    • Local soap makers;
    • Introducers of chemicals in flavor and fragrance blends; and
    • Introducers of hazardous chemicals where introduction and use are controlled; and
  • Strengthening criteria and/or reporting requirements for health and environmental protection.

AICIS announced final changes to the Industrial Chemicals Categorisation Guidelines that will take effect April 24, 2024. According to AICIS, the changes include:

  • Refinement of the requirement to check for hazardous esters and salts of chemicals on the “List of chemicals with high hazards for categorisation” (the List);
  • Provision to include highly hazardous chemicals to the List based on an AICIS assessment or evaluation;
  • Expanded options for introducers to demonstrate the absence of skin irritation and skin sensitization; and
  • More models for in silico predictions and an added test guideline for ready biodegradability.

AICIS states that it will publish a second update to the Guidelines in September 2024 due to industry stakeholders’ feedback that they need more time to prepare for some of the changes. It will include:

  • For the List: add chemicals based on current sources and add the European Commission (EC) Endocrine Disruptor List (List I) as a source; and
  • Refined requirements for introducers to show the absence of specific target organ toxicity after repeated exposure and bioaccumulation potential.

CANADA

Canada Provides Updates On Its Implementation Of The Modernized CEPA: As reported in our June 23, 2023, memorandum, Bill S-5, Strengthening Environmental Protection for a Healthier Canada Act, received Royal Assent on June 13, 2023. Canada is working to implement the bill through initiatives that include the development of various instruments, policies, strategies, regulations, and processes. In April 2024, Canada updated its list of public consultation opportunities:

  • Discussion document on the implementation framework for a right to a healthy environment under the Canadian Environmental Protection Act, 1999 (CEPA) (winter 2024);
  • Proposed Watch List approach (spring/summer 2024);
  • Proposed plan of chemicals management priorities (summer 2024);
  • Draft strategy to replace, reduce or refine vertebrate animal testing (summer/fall 2024);
  • Draft implementation framework for a right to a healthy environment under CEPA (summer/fall 2024);
  • Discussion document for toxic substances of highest risk regulations (winter 2025); and
  • Discussion document on the restriction and authorization of certain toxic substances regulations (winter/spring 2025).

EUROPEAN UNION (EU)

ECHA Checks More Than 20 Percent Of REACH Registration Dossiers For Compliance: The European Chemicals Agency (ECHA) announced on February 27, 2024, that between 2009 and 2023, it performed compliance checks of approximately 15,000 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registrations, representing 21 percent of full registrations. ECHA states that it met its legal target for dossier evaluation, which increased from five percent to 20 percent in 2019. ECHA notes that for substances registered at quantities of 100 metric tons or more per year, it has checked compliance for around 30 percent of the dossiers.

According to ECHA, in 2023, it conducted 301 compliance checks, covering more than 1,750 registrations and addressing 274 individual substances. ECHA “focused on registration dossiers that may have data gaps and aim to enhance the safety data of these substances.” ECHA sent 251 adopted decisions to companies, “requesting additional data to clarify long-term effects of chemicals on human health or the environment.” ECHA states that during the follow-up evaluation process, it will assess the incoming information for compliance. ECHA will share the outcome of the incoming data with the EU member states and the EC to enable prioritization of substances. ECHA will work closely with the member states for enforcement of non-compliant dossiers. Compliance of registration dossiers will remain a priority for ECHA. In 2024, ECHA will review the impact of the Joint Evaluation Action Plan, aimed at improving REACH registration compliance, and, together with stakeholders, develop new priority areas on which to focus. More information is available in our March 29, 2024, blog item.

Council Of The EU And EP Reach Provisional Agreement On Proposed Regulation On Packaging And Packaging Waste: The Council of the EU announced on March 4, 2024, that its presidency and the European Parliament’s (EP) representatives reached a provisional political agreement on a proposal for a regulation on packaging and packaging waste. The press release states that the proposal considers the full life-cycle of packaging and establishes requirements to ensure that packaging is safe and sustainable by requiring that all packaging is recyclable and that the presence of substances of concern is minimized. It also includes labeling harmonization requirements to improve consumer information. In line with the waste hierarchy, the proposal aims to reduce significantly the generation of packaging waste by setting binding re-use targets, restricting certain types of single-use packaging, and requiring economic operators to minimize the packaging used. The proposal would introduce a restriction on the placing on the market of food contact packaging containing per- and polyfluoroalkyl substances (PFAS) above certain thresholds. The press release notes that to avoid any overlap with other pieces of legislation, the co-legislators tasked the EC to assess the need to amend that restriction within four years of the date of application of the regulation.

EP Adopts Position On Establishing System To Verify And Pre-Approve Environmental Marketing Claims: The EP announced on March 12, 2024, that it adopted its first reading position on establishing a verification and pre-approval system for environmental marketing claims to protect citizens from misleading ads. According to the EP’s press release, the green claims directive would require companies to submit evidence about their environmental marketing claims before advertising products as “biodegradable,” “less polluting,” “water saving,” or having “biobased content.” Micro enterprises would be exempt from the new rules, and small and medium-sized enterprises (SME) would have an extra year to comply compared to larger businesses. The press release notes that the EP also decided that green claims about products containing hazardous substances should remain possible for now, but that the EC “should assess in the near future whether they should be banned entirely.” The new EP will follow up on the file after the European elections that will take place in June 2024.

On April 3, 2024, a coalition of industry associations issued a “Joint statement in reference to ‘the ban of green claims for products containing hazardous substances’ in the Green Claims Substantiation Directive (GCD).” The associations “fully support the principle that consumers should not be misled by false or unsubstantiated environmental claims and share the EU’s objective to establish a clear, robust and credible framework to enable consumers to make an informed choice.” The associations express concern that the proposed prohibition of environmental claims for products containing certain hazardous substances “will run contrary to the objective of the Directive to enable consumers to make sustainable purchase decisions and ensure proper substantiation of claims.” According to the associations, for a number of consumer products, “the reference to ‘products containing’ would encompass substances that would have intrinsic hazardous properties,” implying that there would be a ban of making any environmental claim(s), “even if such trace amounts of unavoidable and unintentional impurities and contaminants are present in these products.” The signatories include the International Association for Soaps, Detergents and Maintenance Products; the European Brands Association; APPLiA; the Association of Manufacturers and Formulators of Enzyme Products; CosmeticsEurope; the European Power Tool Association; the Federation of the European Sporting Goods Industry; the International Fragrance Association; LightingEurope; the International Natural and Organic Cosmetics Association; Toy Industries of Europe; Verband der Elektro- und Digitalindustrie; and the World Federation of Advertisers.

ECHA Clarifies Next Steps For PFAS Restriction Proposal: ECHA issued a press release on March 13, 2024, to outline how the Scientific Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will progress in evaluating the proposal to restrict PFAS in Europe. As reported in our February 13, 2023, memorandum, the national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden submitted a proposal to restrict more than 10,000 PFAS under REACH. The proposal suggests two restriction options — a full ban and a ban with use-specific derogations — to address the identified risks. Following the screening of thousands of comments received during the consultation, ECHA states that it is clarifying the next steps for the proposal. According to ECHA, RAC and SEAC will evaluate the proposed restriction together with the comments from the consultation in batches, focusing on the different sectors that may be affected.

In tandem, the five national authorities who prepared the proposal are updating their initial report to address the consultation comments. This updated report will be assessed by the committees and will serve as the foundation for their opinions. The sectors and elements that will be discussed in the next three committee meetings are:

March 2024 Meetings

  • Consumer mixtures, cosmetics, and ski wax;
  • Hazards of PFAS (only by RAC); and
  • General approach (only by SEAC).

June 2024 Meetings

  • Metal plating and manufacture of metal products; and
  • Additional discussion on hazards (only by RAC).

September 2024 Meetings

  • Textiles, upholstery, leather, apparel, carpets (TULAC);
  • Food contact materials and packaging; and
  • Petroleum and mining.

More information is available in our March 18, 2024, blog item.

ECHA Adopts And Publishes CoRAP For 2024-2026: On March 19, 2024, ECHA adopted and published the Community rolling action plan (CoRAP) for 2024-2026. The CoRAP lists 28 substances suspected of posing a risk to human health or the environment for evaluation by 11 Member State Competent Authorities. The CoRAP includes 11 newly allocated substances and 17 substances already included in the previous CoRAP 2023-2025 update, published on March 21, 2023. For 11 out of these 17 substances, ECHA notes that the evaluation year has been postponed, mainly to await submission of new information requested under dossier evaluation. Of the 28 substances to be evaluated, ten are to be evaluated in 2024, 13 in 2025, and five in 2026. The remaining substance of the 24 substances listed in the previous CoRAP was withdrawn as its evaluation is currently considered to be a low priority. According to ECHA, for this substance, a compliance check is needed first. ECHA states that the substance can be placed in the CoRAP list again, if after the conclusion of the dossier evaluation process, concerns remain beyond what can be clarified through dossier evaluation. ECHA has posted a guide for registrants that need to update their dossiers with new relevant information such as hazard, tonnages, use, and exposure.

Comments On Proposals To Identify New SVHCs Due April 15, 2025: A public consultation on proposals to identify two new substances of very high concern (SVHC) will close on April 15, 2024. The substances and examples of their uses are:

  • Bis(α,α-dimethylbenzyl) peroxide: This substance is used in products such as pH-regulators, flocculants, precipitants, and neutralization agents; and
  • Triphenyl phosphate: This substance is used as a flame retardant and plasticizer in polymer formulations, adhesives, and sealants.

UNITED KINGDOM (UK)

HSE Publishes UK REACH Work Programme For 2023/24: In February 2024, the Health and Safety Executive (HSE) published its UK REACH Work Programme 2023/24. The Work Programme sets out how HSE, with the support of the Environment Agency, will deliver its regulatory activities to meet the objectives and timescales set out in UK REACH. Alongside these activities, HSE and the Environment Agency will engage with stakeholders. The Work Programme includes the following deliverables and target deadlines:

Topic Deliverable Target
Substance evaluation Evaluate substances in the Rolling Action Plan (RAP) Evaluate one
Authorization Complete the processing of received applications within the statutory deadline (this includes comments from public consultation and REACH Independent Scientific Expert Pool (RISEP) input) 100 percent
SVHC identification Undertake an initial assessment of substances submitted for SVHC identification under EU REACH during 2022/23 and consider if they are appropriate for SVHC identification under UK REACH Assess up to five
Regulatory management options analysis (RMOA) Complete RMOAs initiated in 22/23 

Initiate RMOAs for substances identified as priorities

 Up to ten 

Up to five
Restriction Complete ongoing restriction opinions 

Begin Annex 15 restriction dossiers

Initiate scoping work for restrictions

 Two

One 

Two

HSE Opens Call For Evidence On PFAS In FFFs: HSE is working with the Environment Agency to prepare a restriction dossier that will assess the risks of PFAS in firefighting foams (FFF). HSE will propose restrictions, if necessary, to manage any significant risks identified. To help compile the dossier, HSE opened a call for evidence. HSE states that it would like stakeholders to identify themselves as willing to engage in further dialogue throughout the restrictions process. In particular, it would like to hear from stakeholders with relevant information on PFAS (or alternatives) in FFFs, especially information specific to Great Britain (GB). Regarding relevant information, HSE is interested in all aspects of FFFs, including:

  • Manufacture of FFFs: Substances used, process, quantities;
  • Import of FFF products of all types: Quantities, suppliers;
  • Use: Quantities, sector of use, frequency, storage on site, products used;
  • Alternatives to PFAS in FFF: Availability, cost, performance in comparison to PFAS-containing foams, barriers to switching;
  • Hazardous properties: SDSs, new studies on intrinsic properties and exposure, recommended risk management measures;
  • Environmental fate: What happens to the FFF after it is used, where does it go;
  • Waste: Disposal requirements, recycling opportunities, remediation; and
  • Standards: Including product-specific legislation, performance, certification.

HSE states that the call for evidence targets companies (manufacturers, importers, distributors, and retailers) and professional users of FFFs, trade associations, environmental organizations, consumer organizations, and any other organizations and members of the public holding relevant information. HSE intends to publish the final dossier, including any restriction proposals, on its website in March 2025. Interested parties will also then be able to submit comments on any proposed restriction.

New GB BPR Data Requirements Will Apply To Applications Submitted In October 2025: The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024, which update the data requirements in Annexes II and III of the GB Biocidal Products Regulation (BPR), were laid in Parliament on March 13, 2024, and came into force on April 6, 2024. The legislation updates some of the data requirements to reflect developments in science and technology. These include the use of alternative testing approaches to determine some hazardous properties that previously relied on animal testing. HSE held a public consultation on the proposed changes in 2023 and has posted a report on the outcome of the consultation. The new data requirements will apply to applications received 18 months after the legislation came into force (October 6, 2025) and do not apply to existing applications. HSE will provide further guidance on the changes in the future.

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Curb Your Pollution: EPA Issues Final Rule to Reduce Toxic Air Pollution

EPA Issues Final Rule to Reduce Toxic Air Pollution from the Synthetic Organic Chemical Manufacturing Industry and the Polymers and Resins Industries

On April 9, 2024, the U.S. Environmental Protection Agency (EPA) announced its final rule that is touted to provide critical health protections to hundreds of thousands of people living near chemical plants. The final rule, signed March 28, 2024, will reduce emissions of hazardous air pollutants, including the toxic chemicals chloroprene and ethylene oxide (EtO). The rule implements sections 111 and 112 of the Clean Air Act.

When fully implemented, the final rule will reduce more than 6,200 tons a year of over 100 air toxics – including EtO and chloroprene – from covered equipment and processes at plants in Texas and Louisiana, along with plants in other parts of the country including Delaware, New Jersey, and the Ohio River Valley.

As part of the final rule, the EPA is also issuing new emissions limits for dioxins and furans. This will reduce more than 23,000 tons of smog-forming volatile organic compounds (VOCs) each year.

EPA’s final rule will also require plants to conduct fenceline monitoring if any of the equipment or processes covered by the rule use, produce, store, or emit EtO, chloroprene, benzene, 1,3- butadiene, ethylene dichloride or vinyl chloride. Fenceline monitoring is used to measure levels of pollution in the air around the perimeter of a facility. The fenceline monitoring provisions of the rule require owners and operators to ensure that levels of these six pollutants remain below a specified “action level.” Fenceline monitoring provides owners and operators the flexibility to determine what measures to take to remain below the action level, while ensuring that they are effectively controlling toxic air pollution.

The final rule will significantly reduce emissions of air toxins, especially those that are potentially harmful for surrounding communities. According to the EPA, these emission reductions will yield significant reductions in lifetime cancer risk attributable to these air pollutants, in addition to other health benefits.

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