EPA Proposes Ban on Perchloroethylene

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Using its authority under the Toxic Substances Control Act (TSCA), EPA has released a proposed rule to ban the use of perchloroethylene (“PCE”) for most commercial and industrial uses. (PCE is also referred to as perc and tetrachloroethylene.) PCE is used in a number of applications and industries, including petroleum manufacturing, aerosol degreasing, and dry cleaning.

The proposed rule follows the Agency’s assessment of the risk to human health presented by the substance. EPA conducted a risk evaluation of the substance under TSCA section 6(b). That assessment determined that PCE, as a whole chemical substance, presents an unreasonable risk of injury to human health as PCE exposure causes a variety of adverse health effects. PCE is a known carcinogen; it also causes neurotoxicity, including impaired visual and cognitive function. Various other health effects were noted by the risk evaluation, including central nervous system depression, kidney and liver effects, immune system toxicity, and developmental toxicity.

Under TSCA section 6(a), EPA is required to address, by rule, any unreasonable risk of injury to health or the environment found during a TSCA risk evaluation. Section 6(a) also requires the Agency to identify actions necessary to ensure the chemical does not continue presenting an unreasonable risk by either a) implementing “a requirement [either] prohibiting or otherwise restricting the manufacturing, processing, or distribution in commerce of such substance or mixture,” or b) “limiting the amount of such substance or mixture which may be manufactured, processed, or distributed in commerce.” To meet these requirements, EPA is proposing to prohibit the manufacture, import, processing, and distribution of PCE for a number of commercial and consumer uses, such as in dry cleaning, spot-cleaning operations and degreasing. The prohibition allows a 10-year phaseout period.

The Agency will still permit limited use of PCE for some uses, particularly those which help its efforts in addressing climate-damaging hydrofluorocarbons (an initiative happening under the American Innovation and Manufacturing Act of 2020). PCE will also be used in uses that are important for national security applications or to meet other critical national needs. In these cases, EPA would require the implementation of a PCE workplace chemical protection program. The chemical protection program would include requirements to meet an inhalation exposure concentration limit and prevent direct dermal contact. The Agency has also put forward prescriptive requirements for laboratory use, recordkeeping, and downstream notification.

EPA will permit certain time-limited exemptions from the ban for certain critical or essential emergency uses of PCE when no alternative is technically or economically feasible safer alternative is available.

EPA Finalizes TSCA CBI Rule

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On June 7, 2023, EPA finalized a rule (88 Fed. Reg. 37155) that puts forth new and amended requirements for parties asserting confidential business information (“CBI”) claims under the Toxic Substances Control Act (“TSCA”). The new rule details specific procedures for the regulated community to submit and support CBI claims and for the Agency to review CBI claims and communicate their determinations to submitters. Additionally, the rule reorganizes existing provisions of the CBI regulations.

The following are the most substantial changes to procedures for submitting and supporting CBI claims under TSCA:

Substantiation Requirements Applicable at Time of Submission

The rule requires that confidentiality claims be asserted and substantiated at the time of submission; substantiation data requires submissions of supporting statements and certification, including but not limited to asserting that the party has taken reasonable measures to protect the confidentiality of the information, and a reasonable basis to believe that the information is not readily available through reverse engineering. (40 CFR 703.5(a)).

Supporting Statement and Certification

Certification of CBI claims is required at the times the statements are submitted.  Submitters will be required to answer a number of questions, many or all of which have been used for some time in EPA’s CBI substantiation templates and certain CDX submissions (e.g., CDR).  Submitters should note that certifications are submitted under penalty of perjury; any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. § 1001.

Electronic Reporting

The final rule mandates that short of very limited exceptions, all CBI claims must be submitted electronically. This requirement is detailed in 40 CFR 703.5(f). Parties should be particularly conscious of this with TSCA Section 8(e) reporting, notifications under TSCA Section 12(b), and polymer exemption notices under TSCA Section 5 because this rule is the first mandating these types of reporting are to be done electronically.

Requirement to Report Health and Safety Information Using Organization for Economic Cooperation and Development (“OECD”) Harmonized Templates

Under the final rule, health and safety information must be provided using OECD harmonized templates. This is in addition to existing requirements that require submitters to provide a full study report. According to the Federal Register notice, the Agency will elaborate on instructions for including OECD harmonized template files (e.g., currently acceptable file types and IUCLID software versions). This requirement can be found at 40 CFR 703.5(g).

Maintenance and Withdrawal of Confidentiality Claims

EPA is requiring that, going forward, company contact information be kept up to date through CDX. When contacting a submitter concerning confidentiality claims, EPA will contact the submitter either through CDX directly or using the contact information provided by the submitter in CDX. When a confidentiality claim is being reviewed, a notice of the review and opportunity to substantiate or re-substantiate the confidentiality claim will be sent to the submitter using the information provided in CDX. Often, this will be done by sending the submitter an email from a CDX account notifying them that a document is available for download from CDX, which is why it is particularly important to have up-to-date information within the CDX platform. The details of this requirement are within 40 CFR 703.5(h).

EPA has also detailed the process for voluntarily withdrawing confidentiality claims submitted either in CDX or by other means. (40 CFR 703.5(i)). For CDX-submitted claims, the submitters must remove confidentiality markings, revise their documents, and resubmit these documents in CDX. For submissions not originally submitted through CDX, there is now a process for withdrawing the CBI claims through CDX using document-identifying details.

EPA Exempts Categories of Genetically Engineered Plant-Incorporated Protectants from Regulatory Requirements

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On May 31, 2023, EPA published a final rule exempting two categories of plant-incorporated protectants (PIPs) created using genetic engineering from certain Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration requirements and from food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA).  In addition to reducing regulatory burden, EPA stated in a press release that the final rule may result in increased research and development in this sector and provide more pest control options for farmers, ultimately reducing the use of conventional pesticides.

PIPs are defined (in part) at 40 CFR 174.3 as “pesticidal substance[s] that [are] intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance.”  In 2001, EPA exempted PIPs derived through conventional plant breeding from FIFRA registration and FFDCA food tolerance requirements, but did not exempt PIPs created using biotechnology.  Because of recent scientific advances, however, EPA writes that PIPs “can now be created through genetic engineering that are virtually indistinguishable from those created through conventional breeding.”  The final rule adds exemptions for the following two categories of genetically engineered PIPs, which EPA states pose no greater risk than PIPs created through conventional breeding:

  1. PIPs in which genetic engineering has been used to insert a gene from a sexually compatible plant or to modify a gene to match a gene found in a sexually compatible plant. This category of PIPs requires EPA confirmation of eligibility for the exemption.
  2. Loss-of-function PIPs, in which a gene is modified through genetic engineering to reduce or eliminate the activity of that gene. The loss of the activity of that gene then results in the pesticidal effect.  For this category of PIP, biotechnology developers can either make a self-determination that their PIP meets the exemption criteria, which requires notification but no EPA review, or request EPA confirmation of eligibility for the exemption.

Exempted PIPs are still subject to the adverse effects reporting requirements at 40 CFR 174.71 and recordkeeping requirements.

In the preamble to the final rule, EPA established that the Agency is open to considering additional PIP category exemptions and expanding the categories of PIPs that are allowed to self-determine without EPA confirmation of their eligibility exemption.

European Chemicals Agency Releases Proposal Banning PFAS

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On February 7, The European Chemical Agency (ECHA) proposed a ban on per- and poly-fluoroalkyl substances (PFAS) as part of the European Union’s Registration, Evaluation, Authorization, and Restriction of Chemicals (“REACH”) regulation. The ban, which would include about 10,000 PFAS substances, could greatly impact US companies that export virtually any product to the European Union (“EU”). These companies will need to examine whether their products contain PFAS before exporting products to the EU.

The proposed ban is the EU’s largest-ever chemicals prohibition. It is intended to achieve the EU’s goal of a non-toxic environment by 2050. ECHA proposes banning chemicals, mixtures, and articles with 25 parts per billion (ppb) or more of a particular PFAS or 250 ppb of a combination of PFAS. ECHA defined PFAS as “Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it).” According to ECHA, this definition encompasses more than 10,000 PFAS. The proposal explains that this definition is aligned with the definition of PFAS published in 2021 by the OECD. Excluded from the scope of the proposed ban are PFAS substances that are fully degradable as they do not fulfill the underlying concern of high persistence. The ban would begin 18 months following the finalization of the restriction, which is anticipated for some time in 2025.

The initial regulation will include a variety of exemptions with phase-out periods of five or 12 years. Pesticides (referred to as biocides in the EU), along with human and veterinary medicines, would also be exempted from the restriction. PFAS used in specialized fire-fighting suppressants, called aqueous film-forming foam (AFFF), are also exempt as they are being phased out through a separate restriction.

The proposed regulation would supersede existing regulations that allow PFAS in products such as food packaging, pesticides (referred to as biocides in the EU), and human and veterinary medicines. PFAS used in firefighting suppressants (aqueous film-forming foam) used largely by airports, fire departments, and military bases, are being phased out through a separate restriction.

Affected businesses may need to evaluate thousands of products for the presence of PFAS, ranging from camping gear to mobile phones. The ban is likely to have a significant impact on any US company selling products in the EU.

ECHA will accept public comments on the proposal until September 2023. EU companies, working through their trade associations, are already commenting on the proposed ban suggesting a longer phase-out period of 32 months instead of the proposed 18 months and additional exemptions where alternatives are not yet available. The final restriction is expected in 2025.

EPA Report: Pesticide Products Test Negative for PFAS

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EPA has released a summary of its findings from a test of 10 pesticide products that reportedly contained PFAS.  While a previous study in the Journal of Hazardous Materials detected PFAS in over half of these pesticide products, EPA’s laboratory concluded that PFAS substances were not present.

EPA’s study employed two different testing methods.  The first method was the same method used in the previous study, and the second was a newly developed testing method specifically designed to detect the presence of PFAS in pesticide products formulated with surfactants.  According to the Agency, one of the most important differences between the testing methods is that the new testing method eliminates interference from oils and surfactants which can sometimes result in false positive detections.

The previous study discovered PFOS in six of the 10 tested pesticides, which are all insecticides commonly used to treat cotton.  Non-targeted techniques suggested that additional PFAS species were present in seven of the 10.  However, despite testing the same samples tested in the previous study, EPA’s study did not find evidence of PFOS or 28 other types of PFAS above the testing instrument’s background levels.

EPA writes that concern over PFAS contamination in pesticides arose in 2020, when the Agency learned of potential contamination in “a small number of mosquitocide products.”  In 2021, EPA preliminarily determined that the PFAS in those products were most likely formed during their containers’ fluorination process.  In 2022, EPA notified the fluorinated container industry of this concern and later released a study evidencing that PFAS can leach into pesticide products through these plastics.  More information on that study can be found in a previous Verdant Law blog post.

EPA’s First PFAS Clean Water Act Enforcement

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On April 26, 2023, EPA announced that the Agency has taken the first federal Clean Water Act enforcement action for PFAS discharges.  The Agency ordered Chemours Company to follow corrective measures relating to exceedances of the limits set for per and polyfluoroalkyl substances (PFAS) in stormwater and wastewater discharges from the Washington Works facility in Parkersburg, WV.  The PFAS limits were set by in the company’s National Pollution Discharge Elimination System (NPDES) permits.

EPA issued an administrative order on consent (AOC) for the facility for exceeding permit limits on PFOA and HFPO Dimer Acid on more than 20 dates from September 2018 to March 2023.  The exceedances were documented in the discharge monitoring reports submitted by the company to the West Virginia Department of Environmental Protection – a permit requirement.  EPA also stated that Chemours was in violation of requirements for properly operating and maintaining all facilities and systems for permit compliance.  The AOC requires that Chemours take the following actions:

1) Implement a sampling plan to analyze PFAS and conduct analysis on the presence of PFAS in the stormwater and wastewater discharges.  The plan must be submitted to EPA for approval.

2) Submit and implement a PFAS treatment plan or minimizing plan to EPA for compliance with the permit limits.

3) Submit its existing Standard Operating Procedures for their management of wastewater for various systems and their revised Storm Water Pollution Prevention Plan.

In its press release, EPA noted that “Administrator Regan has directed EPA staff to use every enforcement tool at our disposal to compel manufacturers of PFAS to characterize, control, and clean up ongoing and past PFAS contamination,”

The AOC can be accessed here.

NEWMOA Announces Draft PFAS Prevention Model Act

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In May 2023, the Northeast Waste Management Officials’ Association (NEWMOA) released a draft PFAS Prevention Model Act (Draft Model Act), model legislation for states to use in advancing the reduction of the use of polyfluoroalkyl substance (PFAS). NEWMOA is a non-profit interstate organization composed of the state environmental agency directors of hazardous waste, solid waste, waste site cleanup, emergency response, pollution prevention, and underground storage tank programs in Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, and Vermont.

NEWMOA seeks to reach the goal of the “virtual elimination of the environmental releases of PFAS into the environment. NEWMOA outlined the following six main goals of this initiative:

  • Reduce/eliminate the use of PFAS in consumer products to the extent feasible.
  • Identify and implement source reduction programs.
  • Ensure that the substitutes for PFAS in products are safer and that there is no regrettable substitution.
  • Coordinate product disclosure, labeling, bans, phase-outs, source reduction, and end-of-life collection on a multi-jurisdiction basis.
  • Help consumers identify products containing PFAS and learn how to properly handle them.
  • Provide regulated entities with regulatory certainty.

To achieve these goals, NEWMOA has put forth what it refers to as a “menu of policy options” that legislators can weigh in their efforts to address PFAS contamination and exposure. By choosing from these options, NEWMOA purports states can adopt more consistent approaches to regulating PFAS-containing products.

The Draft Model Act contains 18 sections, beginning with relevant definitions developed by adapting definitions provided in the Toxics in Packaging Clearinghouse’s model legislation and existing PFAS laws.

The most unique aspect of the Draft Model Act is Section 4, which proposes the creation and implementation of a multijurisdictional clearing house. The role of the clearing house would be to “assist in carrying out the requirements of this Act and to help coordinate collection and reviews of the manufacturers’ notifications regarding PFAS-added products, applications for phase-out exemptions, the collection system plans, applications for alternative labeling/notification systems, education and outreach activities, and other related functions.” The clearinghouse would additionally be responsible for maintaining a database of “all products containing PFAS, including PFAS-added products; a file on all exemptions granted by the participating jurisdictions; a file on alternative labeling plans; and a file of all the manufacturers’ reports on the effectiveness of their collection systems.”

Additional notable provisions include:

  • Requiring PFAS-product manufacturers to provide notice to the relevant agency before the sale of the product in the relevant jurisdiction; if products are sold without the notification, a ban will be placed on the product.
  • Banning the sale of PFAS-added products in the relevant jurisdiction unless the relevant agency has determined that the use of the product is “currently unavoidable” (defined as whether the product is determined to be beneficial to the environment or protective of public health or protective of public safety; there is no technically feasible alternative that has less risk to human health or the environment to use of PFAS in the product; and there is no comparable non-PFAS-added product available at a reasonable cost”).
  • PFAS-added products that qualify for sale under a “currently unavoidable” use must have a label stating that the product contains PFAS.
  • Manufacturers must have an extended producer responsibility plan for a PFAS-containing product collection system, which will require approval from the relevant agency.

NEWMOA has accepted written public comment on the Draft Model Act and aims to finalize the model legislation by the end of summer 2023.

New Study Finds Multiple Toxic Chemicals in Consumer Products

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This May, the American Chemical Society published a new study evaluating the presence of toxic chemicals in consumer products.  The study found use of at least one chemical known to the state of California to cause cancer, reproductive issues, and/or developmental issues in over one hundred types of consumer products.

The study’s authors used data from the California Air Resources Board’s (CARB) Consumer Product Regulatory Program, which collects data on volatile organic compounds (VOCs) in California consumer products.  They then cross-referenced this data against the list of harmful chemicals regulated under California’s Safe Drinking Water and Toxic Enforcement Act, commonly known as Proposition 65 or Prop 65, to determine the hazards posed by each product category.  It should be emphasized that the study provides only a partial picture of the use of hazardous chemicals in consumer products; only about 200 of the 865 Prop 65-listed substances are VOCs.

More than 100 product categories contained at least one VOC chemical listed under Prop 65 (a “listed chemical”).  Consumers were exposed to the greatest number of listed chemicals in categories that included personal care products, cleaners, and household products; for workers, adhesives had the greatest number of listed chemicals.  The study also determined that more than 5,000 tons of listed chemicals were released from California consumer products in 2020.

In general, the product categories with the most listed chemicals were also the categories in which exposures to especially hazardous listed chemicals were highest.  After comparing the product categories with the highest numbers especially hazardous chemicals with the categories with the highest potential exposures, the researchers assembled a list of 30 product categories and 11 especially hazardous chemicals—including formaldehyde and methylene chloride—that they believed should be prioritized for regulation.

In addition, the study noted that certain occupations put workers at particular risk of exposure to listed chemicals.  For example, janitors could be exposed to five prioritized product categories, including cleaners, detergents, and degreasers.  Construction workers, nail/hair salon employees, and automobile maintenance/repair workers were also described as particularly at-risk.

Because CARB only makes data available by product category, the study did not identify particular brands or products in their analysis.

EPA’s SBIR Program Showcases Small Businesses Developing Technologies to Test and Treat PFAS

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This April, EPA’s Small Business Innovation Research (SBIR) Program highlighted eight companies supported by the program that are developing technologies to detect, assess, and treat PFAS in the environment.

Of the eight companies, seven are pioneering technologies to remove PFAS from water, wastewater, and/or other liquids.  They utilize a variety of technological methods: Onvector LLC developed a plasma vortex reactor-based system; Claros Technologies, Inc. uses a photochemical method; and OxByEl Technologies, Inc.’s treatment relies on an electrochemical process.  One company, RemWell Inc., is working on a sonolysis reactor that will remediate PFAS in groundwater when placed in a horizontal well.  Another, BioLargo, Inc., uses an aqueous electrostatic concentrator to capture PFAS in a membrane for further treatment or disposal.

The only highlighted company that does not specialize in PFAS water treatment, Accurate Environmental Laboratories, developed a passive sampling method that determines levels of PFAS contamination in soils and sediments using diffusion.

Many of the small businesses report impressive efficacy, and some of their technologies are being applied in real-world situations.  Aquagga’s hydrothermal alkaline groundwater treatment process will soon be used for remediation projects at airports and air force bases.  Meanwhile, Cyclopure, Inc. is in the process of constructing full-scale regeneration and PFAS destruction facilities to administer its adsorbent-based PFAS water treatment.

Every year, EPA’s SBIR Program solicits technological proposals that address specific environmental topics.  Winning proposals are awarded contracts for “proof of concept” of the proposed technology and are eligible to apply for additional funding to further develop and commercialize the technology.  In five of the last six years, the program has included a PFAS-related topic in its batch of solicitations.

EPA Releases Chemical Data Reporting National Review

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EPA has released its first-ever Chemical Data Reporting (CDR) National Review (“Review”), which provides a comprehensive analysis of data submitted to the Agency during the 2020 CDR reporting cycle. The report presents information about chemicals that were manufactured and imported into the US from 2016 through 2019. In its press release on the Review, the Agency stated that the document will assist stakeholders in evaluating and understanding information about the types, quantities, and uses of chemicals produced domestically or imported into the U.S.

Manufacturers and importers of chemical substances listed on the Toxic Substances Control Act (“TSCA”) Inventory are required to report data to the EPA every four years if they manufacture or import substances at or above specific thresholds unless the chemical has been exempted from the reporting requirement. Typically reporting is required when an entity manufactures or imports 25,000 pounds or more of a chemical during any year in the reporting period at any single site. Companies must report how chemicals are processed or used (industrial processing and use data), and whether they are used in commercial or consumer products (commercial and/or consumer use data) in addition to manufacturing and import volumes.

According to EPA, the CDR database is the most comprehensive source of basic screening-level, exposure-related information on chemicals that is available to the Agency. EPA uses the database to screen and prioritize chemicals for further review.

The Review summarizes data from the most recent CDR reporting cycle data (2020), covering activities from 2016 to 2019, and provides trend data for reporting over the past decade. During this reporting period, more than 7.2 trillion pounds of chemicals were manufactured or imported at 5,238 sites.

The Review provides interactive trend analysis, including an interactive map of CDR sites and characteristics of the communities in which these sites are located.  It also includes maps displaying CDR reporting sites by state, and figures with production volumes. In addition, the Review contains informational charts and figures to increase understanding of a variety of CDR data elements, such as analyses of chemical use information. Environmental justice tools from EPA’s EJScreen, the Agency’s environmental justice mapping tool, are also contained in the document.

The Review’s key findings include:

  • Of the more than 8,000 chemicals reported for the 2020 CDR reporting cycle, about 54% were manufactured domestically, and 46% were imported. This is a 10% increase in imported chemicals from the 2016 CDR.
  • Two industry sectors manufactured and imported the bulk of the volume reported to the 2020 CDR: petroleum and coal products manufacturing (64%) and chemical manufacturing (14%). Although it produced less volume than the petroleum and coal products sector, the chemical manufacturing sector produced the majority of chemicals (84%) reported to the 2020 CDR and represented nearly half (43%) of all sites.
  • 180 PFAS were reported by 57 sites for a total production volume of about 678 million pounds.
  • Of the 37 Chemicals undergoing Risk Evaluation, 33 chemicals were reported to the 2020 CDR; that is, they were manufactured or imported at above threshold volumes (2,500 lbs.) in at least one year during the reporting cycle. Thirty-four Risk Evaluation chemicals were reported in both the 2012 and 2016 reporting cycles.
  • Total production volume for the 33 TSCA Risk Evaluation chemicals was about 38 billion pounds. The volume was reported across 254 sites.
  • The number of sites that manufactured and/or imported TSCA Risk Evaluation Chemicals has increased by 40% over the past 10 years, while the manufactured and imported volumes have generally remained consistent.