EPA Requests Comment on Petition Requiring Proof of Effectiveness for Systemic Insecticides

On November 24, 2023, EPA announced that the Agency is seeking public comment on a petition filed by environmental groups requesting that EPA consider efficacy data when evaluating the registration of neonicotinoids and other systemic insecticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Comments will be accepted through January 23, 2024.

In 1980, EPA waived (in most cases) the requirement that registrants provide efficacy data when registering a pesticide under FIFRA (see 40 CFR 158.400(e)(1)).  The petition, filed by the Public Employees for Environmental Responsibility and the American Bird Conservancy, argues that neonicotinoid use is largely ineffective and causes widespread environmental harm.  According to the petition, EPA’s failure to consider neonicotinoids’ lack of efficacy conflicts with the stated purposes of the Agency’s FIFRA registration data requirements to “make regulatory judgments…about the risks and benefits of pesticide products” (40 CFR 158.1(a)) and “ensure that pesticide products will perform as intended” (40 CFR 158.130(c)).

In addition to requiring efficacy data during systemic insecticide registration, the petition asks EPA to mandate that existing systemic insecticide registrants submit efficacy data to EPA within 180 days.  If a proposed or existing systemic insecticide registration “lacks a demonstration that its benefits exceed its environmental and overall costs,” EPA would be required to deny or revoke the registration accordingly.

Systemic insecticides are most commonly used prophylactically to treat plant seeds.  Treated seeds are currently exempted from FIFRA under the “treated articles and substances” exemption at 40 CFR 152.25(a) if their use is consistent with the treating pesticide’s label instructions.  However, EPA recently signaled that the Agency may revise this exemption.

Systemic insecticides are designed to be absorbed and transported through the target plant.  Neonicotinoids, a class of systemic insecticides that include the active ingredients imidacloprid, thiamethoxam, and clothianidin, are one of the most widely used types of insecticides in the world.

Federal Court Requests Scientific Information on Diseases Associated with PFAS Exposure

Parties must gather scientific evidence on the human health effects attributable to PFAS exposure in drinking water, the US District Court for the District of South Carolina ordered in the case In Re Aqueous Film-Forming Foams Products Liability Litigation MDL 2873 last week.  The multi-district litigation focuses on the health hazards posed by aqueous film-forming foams (AFFFs), which are used as fire suppressants and allegedly contain PFAS such as PFOA and PFOS.

Plaintiffs allege that AFFF use at military bases, airports, and other locations caused the release of PFAS into local groundwater, which then entered the water supply.  According to Judge Richard Mark Gergel’s order, the litigation now includes over 20,000 cases, the majority of which raise personal injury claims.

The court adopted a bellwether program for these claims, focusing on alleged connections between exposure and four diseases: kidney cancer, testicular cancer, hypothyroidism/thyroid disease, and ulcerative colitis.  However, Gergel wrote that those diseases only make up a “small minority” of personal injury cases.  To determine which of the other cases have merit, Gergel directed the parties to propose a case management order within 60 days that includes the following:

  • A date by which plaintiffs must identify diseases not addressed in the bellwether program that they allege are the result of exposure to AFFF-contaminated drinking water,
  • A date by which the parties must produce peer-reviewed articles that support or challenge an association between exposure to AFFF-contaminated drinking water and an identified disease,
  • A plan for a science day where the parties can present experts to address those associations and
  • A plan for selecting bellwether cases for those associations.

In a separate order, Gergel stated that the court would select 28 personal injury cases as bellwether cases from a list of proposed bellwether cases submitted jointly by the parties.

California Glyphosate Warning Requirement Ruled Unconstitutional Compelled Speech

California’s requirement that glyphosate-containing products display a carcinogen warning violates the First Amendment, a Ninth Circuit Court of Appeals panel ruled in a 2-1 decision on November 7, 2023. The decision in the case Nat’l Assoc. of Wheat Growers v. Bonta affirmed a district court’s summary judgment and injunction against the requirement.

Proposition 65 (known as “Prop 65”) requires that any product intentionally containing a chemical on California’s list of known carcinogens warn customers of the product’s carcinogenicity. Glyphosate, one of the most widely used herbicides and the active ingredient in the weed killer Roundup, was automatically added to the list of Prop 65 carcinogens following a 2015 determination by the International Agency for Research on Cancer that glyphosate is “probably carcinogenic to humans.” Other organizations, such as EPA, have not found that glyphosate poses a risk to humans, however.

According to the court, compelled commercial speech must pass intermediate scrutiny unless it is “purely factual and uncontroversial information,” in which case a lesser level of scrutiny applies. The panel found that this exemption was not applicable because whether glyphosate is carcinogenic is subject to scientific debate. The panel then determined that the labeling requirement did not survive intermediate scrutiny because “warn[ing] consumers of a potential ‘risk’ never confirmed by any regulatory body” does not directly advance California’s interest in preserving public health.

The warning was previously struck down by a California district court on the grounds that its phrasing would be misleading to customers, it was not purely factual and uncontroversial, and a more equivocal warning would likely not comply with Prop 65. In this case, the panel analyzed three new proposed warning messages from California’s Attorney General and another from California’s Office of Environmental Health Hazard Assessment (OEHHA) but concluded that these warnings were also not purely factual and uncontroversial.

Judge Consuelo M. Callahan wrote for the panel and was joined by Judge Patrick J. Bumatay. Writing in the dissent, Judge Mary M. Schroeder argued that, at minimum, the new OEHHA warning should be remanded to the district court. Schroeder argued that the majority applied inappropriate precedent in determining what makes a statement uncontroversial, failed to examine the actual content of the warning, and ignored the fact that EPA’s most recent determination that glyphosate is unlikely to cause cancer was vacated by the Ninth Circuit in Nat. Res. Def. Council v. U.S. Env’t Prot. Agency (2022) because it was not supported by substantial evidence.

OEHHA Proposes Amendments to Prop 65 Warning Requirements

This October, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed amendments to the “safe harbor” warning requirements under Proposition 65, the California Law that requires businesses with at least ten employees to provide a “clear and reasonable” warning to customers about exposures to chemicals known to the state of California to cause cancer or reproductive toxicity (officially called the Safe Drinking Water and Toxic Enforcement Act of 1986). The proposed amendments to the safe harbor warning requirements for Proposition 65 (known as “Prop 65”) focus on short-form warnings, provisions for internet and catalog purchases, and warnings for motor vehicles and recreational marine vessel parts.

Requirement of chemical identification in short-form warnings

Under regulations adopted in 2016, safe harbor warnings generally require the name of at least one chemical for each health effect covered by the label. However, because small products may not have space for a full-length warning, OEHHA included an optional short-form label that does not require businesses to identify the chemical(s) prompting the warning. However, since the adoption of the regulations, OEHHA has found that many businesses have chosen to use the short-form label regardless of product size. OEHHA also found that some businesses use short-form labels in situations where there is no risk of exposure to a Prop 65 chemical as a litigation avoidance strategy, diluting the impact of legitimate warnings. As a result, OEHHA proposes that short-form labels identify a chemical for each health effect covered by the label beginning two years after the rule’s effective date.

Provisions for internet and catalog purchases

OEHHA is aware of confusion among businesses about how to provide warnings for products purchased online. For example, some businesses have expressed confusion as to whether an online warning is necessary if the product has a warning on its label and vice versa. To clarify, OEHHA proposes that warnings be required both online and on the product label, or in the case of a catalog, both in the catalog and on the product. OEHHA additionally clarifies the requirements for online warnings; a business must include either a warning on the product display page, a hyperlink on the product display page using the word “WARNING” that links to the warning, or an otherwise prominently displayed warning made to the purchaser prior to completing the purchase.

Warnings for motor vehicles and recreational marine vessel parts

OEHHA states that passenger and off-highway motor vehicles and recreational marine vessel parts present a unique challenge because parts are often too small to comfortably fit full-length warnings and because consumer exposure varies substantially from person to person. To address these concerns, OEHHA proposes that businesses selling these parts can choose to provide a general exposure warning (either at each retail point of sale or point of display) in lieu of a warning on the product label.

Other proposed revisions include explicitly allowing the use of short-form warnings on food products, allowing warnings to begin with “CA” or “CALIFORNIA WARNING” instead of just “WARNING,” allowing more flexibility for warning font sizes and adding additional language to clarify that warnings be placed conspicuously.

The proposed amendments are similar to amendments proposed by OEHHA in January 2021. OEHHA was unable to complete that rulemaking within the regulatory time limit. The current proposal is the first on safe harbor warning requirements since that time.

Comments on the proposed amendments are due December 20, 2023. In addition, OEHHA will hold a hybrid public hearing on the proposed amendments on December 13, 2023, at 10:00 AM PST.

EPA Finalizes TRI PFAS Reporting Rule

On October 31, EPA published its final rule, Changes to Reporting Requirements for PFAS and to Supplier Notifications for Chemicals of Special Concern which modifies the requirements for TRI reporting. These new requirements take effect November 30, 2023, and will apply for the reporting year beginning January 1, 2024; first reports with these requirements will be due July 1, 2025. The rule puts forth two significant changes to the current reporting requirements.

The first change to the reporting requirements is that all PFAS presently subject to TRI reporting will be added to the TRI list of Chemicals of Special Concern (“COSC List”). In addition, in the future, any PFAS added to the TRI list of toxic chemicals will automatically be added to the COSC list without the Agency having to go through a separate rulemaking process as was previously required. Furthermore, all PFAS on the COSC list will be held to the same reporting standard as all other chemicals on the COSC list. This means that all PFAS will be excluded from the de minimis exemption, which had excused quantities of PFAS present in mixtures at less than 1 percent (0.1 for PFOA) from contributing to reporting thresholds. In addition, facilities will no longer be able to report these substances on Form A (the less extensive of the reporting forms) and will not be able to report quantities using ranges. Under the requirements previously in place, Form A could be used for PFAS reporting if each of the following criteria has been met:

  • The reportable chemical substance is not a PBT.
  • The reportable chemical substance was not manufactured, processed, or otherwise used in excess of 1,000,000 lbs.
  • If the total reportable amount of the chemical substance released did not exceed 500 lbs.

Under the new requirements, no one will be able to report PFAS manufacture, processing, use, and releases on Form A. However, Form A can still be used to meet the reporting requirements for PFAS during the 2023 reporting year; beginning in 2024, PFAS will need to be reported using the more extensive Form R.

The second change to the TRI reporting requirements eliminates the de minimis exemption under the supplier notification requirements for all COSC, including PFAS. This change also goes into effect for the 2024 reporting year. The de minimis exemption for supplier notification meant that raw material suppliers were not required to notify their customers of the presence of PFAS in mixtures below specific concentrations (1 percent for non-carcinogens and 0.1 percent for carcinogens or, in the present case, 1 percent for PFAS and 0.1 percent for PFOA). Eliminating the de minimis exemption for reporting will add notification requirements on suppliers of products containing COSC and include such information on their SDSs. Consequentially, facilities will have more information about their processing, use, and/or release of PFAS, and downstream manufacturers will likely have more information to report to EPA for TRI.

EPA Proposes TCE Ban

EPA has released a proposed rule, which, if implemented, would ban the use of trichloroethylene (“TCE”). The substance has numerous industrial, commercial, and consumer applications, including uses in vapor and aerosol degreasing and as lubricants, greases, adhesives, and sealants. Earlier this year, in its final revision to the TCE risk evaluation conducted under section 6(b) of the Toxic Substances Control Act (“TSCA”), EPA concluded that TCE presents an unreasonable risk of injury to human health due to both its carcinogenic and non-carcinogenic health effects including liver and kidney toxicity, and neurotoxicity. The risk evaluation found these effects resulted from both acute and chronic exposures and through all types of exposures, including inhalation and dermal exposure. TSCA section 6(a) requires EPA to impose restrictions on the manufacture, including import, processing, and distribution of substances that present an unreasonable risk of injury to human health or the environment.

The ban would apply to all manufacturing, import, processing, and distribution in commerce of TCE for all industrial and commercial uses. The rule would go into effect one year following the effective date of the final rule for consumer products and most commercial uses. Some commercial and industrial uses would have longer phaseout timelines and set exemption periods. (The difference between phaseouts and exemptions is that phaseouts are active timelines for the elimination of use, whereas the exemptions do not require current action to eliminate the use of TCE by a certain date; presumably, a determination will be made prior to the exemption period ending that will clarify if the exemption is to be extended or if a phaseout period will be established.)

TSCA section 6(g) allows EPA to grant an exemption from a requirement of a rule banning or restricting a chemical substance for a specific condition of use of a chemical substance if the Administrator finds that the specific condition of use is critical or essential and has no technically and economically feasible safer alternative. The phaseout and exemptions in the proposed rule are narrow in scope. They include the following:

  • An 8.5-year phaseout for the manufacture and processing of TCE as an intermediate in the manufacturing of hydrofluorocarbon134a (HFC-134a). HFC-134a is essential to the operation of refrigeration and air conditioning systems.
  • A 10-year phaseout for the manufacture and use of TCE as a solvent for closed-loop batch vapor degreasing for rayon fabric scouring for end use in the production of rocket booster nozzles. This exemption is limited to production by federal agencies and their contractors.
  • A 10-year TSCA Section 6(g) exemption for the manufacture and processing of TCE as a processing aid for battery separator manufacturing, battery separators are used to prevent short-circuiting in lithium-ion batteries.
  • A 50-year TSCA Section 6(g) exemption for the manufacture, processing, distribution in commerce, and use of TCE as a laboratory chemical for essential laboratory activities such as those associated with ongoing environmental cleanup projects under the CERCLA program and other EPA authorities, and some research and development activities being conducted by U.S. Federal Agencies including NASA.

The rule would also require strict workplace controls for those working with TCE for the uses allowed by the proposed rule.  These workplace controls would be detailed in EPA’s proposed  Workplace Chemical Protection Program (“WCPP”). To further reduce worker risks, the proposed rule would prohibit the disposal of TCE to industrial pre-treatment, industrial treatment, or publicly owned treatment works.

Under this rule, manufacturers, importers, processors, and distributors (excluding retailers) of TCE and TCE-containing products must provide downstream notification of the TCE prohibition. EPA is asking for comments on timeframes for downstream notification and recordkeeping requirements. EPA is proposing a two-month period for manufacturers and a six-month period for processors and distributors to make the required SDS changes. This notification will be provided through Safety Data Sheets (“SDS”). The suggested SDS language is stated within the proposed rule.

Violations of the rule will be subject to TSCA section 16, which permits civil and criminal penalties, including a civil penalty of up to $46,989 per day for each violation of TSCA or TSCA rules. Comments on the proposed rule are due December 15, 2023.

EPA Releases Strategic Plan for Endocrine Disruptor Screening Program

EPA has released a notice requesting comment on its strategic plan to meet its obligations under the Federal Food, Drug, and Cosmetic Act (FFDCA) to screen for and protect against endocrine-disrupting effects in humans. Endocrine disruptors are chemicals that mimic, block, or disrupt the normal function of endocrine system hormones and can negatively impact biological processes within the endocrine, immune, and nervous systems. Under the new program, the Agency will assess pesticides more quickly and effectively to evaluate their potential to cause endocrine effects in humans. These assessments will be incorporated into pesticide review efforts made under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”).

In the Agency’s press release regarding the program, the Deputy Administrator for Pesticide Programs in the Office of Chemical Safety and Pollution, Jake Li, noted that the program is a major milestone. He also stated that “starting with our highest priority chemicals, EPA will communicate more transparently our endocrine findings for humans.”

EPA review of preliminary data has identified 30 high-priority pesticides that these chemicals affect the endocrine system. The Agency requests additional endocrine data for human health for these chemicals in its request for comment. The Agency intends to fill any remaining data gaps by issuing FIFRA human health data requests for these chemicals in early 2024. These chemicals are identified in EPA’s List of Conventional Registration Review Chemicals, for Which an FFDCA Section 408(p)(6) Determination is Needed, which is available in docket EPA–HQ–OPP–2023–0474 on regulations.gov. FFDCA section 408(p)(6) requires EPA to ‘‘as appropriate, take action under such statutory authority as is available to the Administrator, including consideration under other sections of this chapter, as is necessary to ensure the protection of public health’’ for ‘‘any substance that is found, as a result of testing and evaluation under this section, to have an endocrine effect on humans.’’ In addition, in the Federal Register notice, EPA requested that stakeholders submit data on the endocrine effects of these pesticides. Data are requested during the notice’s 60-day comment period. After the assessment of the high-priority pesticides is completed, the Agency will request data on a second group of 126 pesticides.

In the strategic plan, EPA explains that the program will pull from existing data when possible.   and request new data if needed. Existing data has been collected under FIFRA and the FFDCA. EPA has chosen 400 conventional pesticide active ingredients that are being registered for the first time or are undergoing registration review for which, through the implementation of its Strategic Plan, the Agency will assess for endocrine effects and determine if additional protections are needed.

The comment period for this notice began on October 27, 2023, and has been extended to February 26, 2024.

Environmental Groups Drop Lawsuit Following EPA Finalization of TRI PFAS Reporting Rule

Environmental and health advocate groups, including the National PFAS Contamination Coalition and Union of Concerned Scientists, have dropped their lawsuit against EPA, challenging two of the Agency’s rules related to PFAS reporting under the Toxics Release Inventory of the Emergency Planning and Community Right-to-Know Act. The 2022 lawsuit alleged that the Agency’s rules Implementing Statutory Addition of Certain Per- and Polyfluoroalkyl Substances; Toxic Chemical Release Reporting and Implementing Statutory Addition of Certain Per- and Polyfluoroalkyl Substances (PFAS) to the Toxics Release Inventory Beginning with Reporting Year 2021, weakened PFAS reporting requirements imposed by the 2020 National Defense Authorization Act (NDAA) by allowing di minimus and alternative threshold exemptions.

The Plaintiffs agree that the issues raised in their 2022 complaint have been sufficiently addressed in EPA’s October 2023 final rule Changes to Reporting Requirements for Per- and Polyfluoroalkyl Substances and to Supplier Notifications for Chemicals of Special Concern; Community Right-to-Know Toxic Chemical Release Reporting which modified the TRI reporting requirements. The amended rule eliminates the di minimus reporting exemption with the purpose of increasing the amount of data on PFAS chemicals released to the environment required to be submitted to the Agency beginning in 2025. More detailed information on the new TRI PFAS reporting requirements can be found here. In both the proposed and final rule, EPA stressed that the two prior rules, the ones at issue in the litigation, resulted in minimal reporting on PFAS releases, and therefore, eliminating exemptions was necessary to achieve the goals of the NDAA.

EPA to Consider Revising FIFRA Exemption for Pesticide-Treated Seeds and Paint

On October 12, 2023, EPA published an advance notice of proposed rulemaking on seeds (“treated seeds”) and paint (“treated paint”) treated with a pesticide that is registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (“treating pesticide”). Treated seeds and treated paints are currently exempted from FIFRA under the “treated articles and substances” exemption at 40 CFR 152.25(a) as long as their use is consistent with the treating pesticide’s label instructions.

EPA’s longstanding position has been that subjecting treated articles to FIFRA requirements would be unnecessary since the treating pesticide would have already been assessed during the pesticide registration process. This position was challenged in 2017 by the Center for Food Safety, which filed a petition requesting that EPA remove the exemption for treated seeds and aggressively enforce FIFRA’s pesticide labeling and registration requirements for seeds treated with systemic insecticide chemicals. EPA denied the petition in 2022 but acknowledged that the use of a treated seed contrary to the treating pesticide’s labeling instructions is generally not enforceable under FIFRA. As a result, EPA noted its intention to issue the current advance notice of proposed rulemaking to collect more information on treated seeds. EPA also included treated paints in the notice because of concerns that painters may be exposed to treated paint without adequate PPE.

The information specifically requested by the notice falls into five main categories:

  1. Effectiveness of instructions on treated seed product labeling to mitigate potential risks. EPA seeks comment on the Agency’s labeling instructions for treated seeds, particularly with regard to whether these instructions are clear, generally achievable, and adequate.
  2. Use, usage, and tracking of treated seed products. EPA seeks comment on the use, usage rates, and volume of imports of treated seeds. EPA also seeks comment on whether tracking treated seed distribution, sale, and/or use would provide any meaningful improvements in the assessments of treating pesticides and whether the treated article exemption should be amended so that manufacturers of treated seeds would be subject to FIFRA section 7 registration and reporting requirements.
  3. Management of spilled or excess treated seed. EPA included additional labeling instructions for the management of spilled and excess treated seed in the registration review proposed interim decisions and interim decisions of several chemicals. EPA seeks comment on whether these instructions are sufficient. EPA also seeks comment on what farmers, distributors, and companies currently do with excess treated seed.
  4. Treated paint. Pesticide labeling requirements for treated paint do not currently exist. EPA seeks comment on whether it should add pesticide labeling requirements and what those requirements should include. EPA also seeks comment on whether it should add specific use instructions or enforceable use requirements for professional painters and whether the treated article exemption should be amended so that manufacturers of treated paints would be subject to FIFRA section 7 registration and reporting requirements.
  5. Administrative action, amendment of the treated article exemption, and/or FIFRA section 3(a) rule. EPA seeks comment on whether action is necessary to prevent unreasonable adverse effects on human health and the environment, considering the concerns raised regarding the enforceability of labeling instructions on treated seeds and paint and whether there are any such examples of the use of treated seed contrary to labeling instructions. If so, EPA requests comments on what the proper action should be and how such an action might impact states.

EPA also requests comments on whether exposure to treated seeds and paint may be an environmental justice concern and comments regarding potential child health concerns. Comments on the notice will be accepted through December 11, 2023.

EPA Proposes Changes to TSCA Risk Evaluation Procedures

On October 30, 2023, EPA published a proposed rule altering the procedures for chemical risk evaluations under section 6 of the Toxic Substances Control Act (TSCA). The proposed rule revises the existing 2017 framework, which was adopted one year after Congress passed amendments to TSCA requiring EPA to evaluate whether existing chemicals that have been identified as “high priority” present an unreasonable risk of injury to health or the environment.

The rulemaking includes the following proposed changes:

  • The clarification that EPA will include all conditions of use (i.e., circumstances under which the chemical is “intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of”) in the scope of a risk evaluation.
  • The inclusion of all exposure pathways in the scope of a risk evaluation. EPA previously excluded exposure pathways covered under other EPA statutes in its risk evaluations for the first ten chemicals.
  • The removal of the definitions for “best available science” and “weight of the scientific evidence.” Though TSCA requires EPA to use the best available science and make decisions based on the weight of the scientific evidence at 15 U.S.C. 2625, EPA argues that the codification of these definitions inhibits the Agency’s ability to adapt to changing science.
  • The requirement that EPA make a single determination on whether the chemical presents an unreasonable risk. EPA initially made separate risk determinations for each condition of use in its risk evaluations for the first ten chemicals but later issued revised “whole substance” determinations.
  • The cessation of the consideration of “assumed” personal protective equipment (PPE) use when calculating exposure reduction due to PPE.
  • The addition of “overburdened communities” to the list of examples of potentially exposed or susceptible subpopulations.
  • A number of alterations to the process and requirements for manufacturer-requested risk evaluations.

The above changes would apply to all risk evaluations initiated on or after the date of the final rule.  For risk evaluations in progress on the date of the final rule, EPA expects to apply the changes “only to the extent practicable.”

The proposed clarification that EPA includes all conditions of use in the scope of a risk evaluation stems from the Ninth Circuit’s 2019 decision in Safer Chemicals, Healthy Families v. US EPA. In the case, petitioners successfully challenged EPA’s exclusion of “legacy uses and associated disposals”—such as the use and future disposal of asbestos in previously installed insulation—from the scope of risk evaluations. Several of the other proposed changes would codify existing EPA practices introduced in 2021, including the requirement that risk evaluations end with a single determination rather than use-by-use determinations.

EPA requests public comments on all aspects of the proposed rulemaking. Comments are due on December 14, 2023.