Hearing Announced on EPA’s Intent to Cancel Chlorpyrifos Pesticide Registrations

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On June 21, 2023, EPA announced that a public hearing will be held in response to objections and hearing requests following EPA’s issuance of a Notice of Intent to Cancel (“NOIC”) pesticide registrations for three products containing chlorpyrifos. The hearing will begin at 9 a.m. on January 8, 2024, and will continue as necessary through January 11, 2024.

The objections and hearing requests following the NOIC came from a collection of grower groups and a producer of chlorpyrifos products. The petitioners are currently challenging EPA’s 2021 final rule, which revoked all tolerances for chlorpyrifos, in the Eighth Circuit case Red River Valley Sugarbeet Growers Association et al. v. Regan. The petitioners argue that EPA should stay or withdraw the NOIC until the pending case is decided.

EPA’s NOIC was the result of over a decade of efforts to ban chlorpyrifos use. In 2007, two non-profit organizations filed a petition requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos, pointing to studies showing neurotoxic, developmental, endocrinal, and carcinogenic effects in humans and animals as a result of exposure. EPA did not take final action on the petition until it denied the petition in 2017, concluding that the science behind the effects of exposure remained unresolved.  In 2021, the Ninth Circuit vacated EPA’s decision in League of United Latin Am. Citizens v. Regan. The court held that EPA had abdicated its statutory duty under the Federal Food, Drug, and Cosmetic Act by failing to update the tolerances for chlorpyrifos despite its inability to conclude, to the statutory standard of reasonable certainty, that present tolerances caused no harm. The court ordered EPA to grant the 2007 petition and modify or revoke the tolerances accordingly. EPA opted to revoke all tolerances in the final rule.

In the ongoing case, Red River Valley Sugarbeet Growers Association et al. v. Regan, the grower groups and the chlorpyrifos producer argue that the final rule was arbitrary and capricious due to EPA’s disregard for safe chlorpyrifos uses. The petitioners observe that shortly before the final rule was published, EPA completed a human health assessment that found that chlorpyrifos use on eleven crops in select regions was safe. By refusing to act on its own evidence, the petitioners assert that EPA disregarded its statutory mandate to review the safety of tolerances using current science.

According to EPA, chlorpyrifos was registered for use in the U.S. beginning in 1965. At the time of the final rule, chlorpyrifos was registered for use on fruit and nut trees, many types of fruits and vegetables, and grain crops.

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.

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.

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.

EPA Releases Draft National Strategy to Prevent Plastic Pollution

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In April, EPA released the Draft National Strategy to Prevent Plastic Pollution. This strategy document, part of EPA’s Series on Building a Circular Economy for All, outlines voluntary actions aimed at eliminating plastic waste released into the environment from land-based sources by 2040. Under this plan, EPA seeks to reduce, reuse, recycle, collect, and capture plastic waste. The draft strategy comprises three primary objectives, each focusing on different aspects of plastic pollution prevention:

Objective A: Reduce pollution during plastic production

This objective emphasizes minimizing pollution throughout the life cycle of plastic products. It encourages manufacturers and consumers to implement upstream actions such as designing products for reuse and recycling, using less impactful materials, and controlling plastic production facilities. Proposed actions include reducing the production and consumption of single-use, unrecyclable, or frequently littered plastic products, as well as minimizing pollution across the entire life cycle of plastic products.

Objective B: Improve post-use materials management

While the National Recycling Strategy identified actions to enhance recycling, this objective expands the focus to other pathways of circularity, including reuse, refill, and composting. Proposed actions involve conducting a study of existing policies and incentives to evaluate their effectiveness, developing or expanding capacity for maximizing material reuse, facilitating effective composting, increasing solid waste collection, enhancing public understanding of plastic mismanagement, and exploring ratification of the Basel Convention for environmentally sound management of scrap and recyclables.

Objective C: Prevent trash and micro/nanoplastics from entering waterways and remove escaped trash from the environment

Proposed actions include implementing policies, programs, and compliance assurance measures to prevent trash and microplastics from entering waterways, improving water management to capture trash in waterways and stormwater/wastewater systems, increasing awareness of the impacts of plastic products in waterways, and coordinating research on micro/nanoplastics.

The agency aims to gauge the importance of different actions, identify key steps and milestones for successful implementation, determine the roles and actions federal agencies should lead, and evaluate potential unintended consequences on overburdened communities. EPA also seeks input on relevant metrics and indicators to measure progress and invites recommendations for additional actions to include in the strategy.

Community Sues EPA Over Terms for Production of Petrochemical Fuel

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Cherokee Concerned Citizens, on behalf of the Cherokee Forest neighborhood  a fenceline community in Pascagoula, Mississippi, has filed a petition in the U.S. Court of Appeals for the District of Columbia Circuit for review of a TSCA section 5(e) consent order. The consent order covers 18 chemicals that were the subject of premanufacture notifications submitted by Chevron in 2021. In its press release announcing the litigation, Earthjustice asserted that the production of these chemicals would result in air pollution that would pose a 1 in 4 cancer risk (25 % of the residents living nearby could develop cancer over their lifetime), 250,000 times greater than what the Agency typically considers unreasonable.

TSCA requires EPA to regulate the manufacturing, processing, and distribution of substances that present an unreasonable risk of injury to health or the environment without consideration of costs or other non-risk factors. The Statute states that the Administrator shall issue consent orders and significant new use rules “to the extent necessary to protect against such risk.”

EPA identified skin and eye irritation; acute toxicity; systemic toxicity (neurotoxicity, body weight effects, and liver, kidney, blood, spleen, and other organ effects); reproductive and developmental toxicity; oral and inhalation portal of entry effects; genetic toxicity; and carcinogenicity as hazards of these New Chemical Substances. These hazards were identified based on the substance’s estimated physical/chemical properties by comparing them to compositionally analogous mixtures for which there is information on human health hazard, using available human hazard information on representative constituents of these New Chemical Substances, and other structural information. As is often the case with PMNs, there were no experimentally derived hazard data for these New Chemical Substances.  For a number of the substances, risks were identified for the general population (infants) for systemic and/or oral portal-of-entry effects via drinking water. Risks to adults for this exposure route were also identified. In addition, risks were identified for the general population for systemic and/or inhalation portal-of-entry effects via fugitive air inhalation for some of the substances at issue.

The consent order imposes worker protection and limitations on the distribution of the new chemical substances. It does not restrict air emissions or wastewater discharges of the substances. The Chevron facility called out by Earthjustice is permitted under the Clean Air and the Clean Water Acts.