EPA Proposes to Revise Rules for PBTs DecaDBE and PIP (3:1)

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On November 24, 2023, EPA released a proposed rule to revise the final rules for decabromodiphenyl ether (“decaBDE”) and phenol, isopropylated phosphate (3:1) (“PIP (3:1)”), two persistent, bioaccumulative, and toxic substances (PBTs) subject to regulation under section 6 of the Toxic Substances Control Act (TSCA).

Section 6(h) of TSCA (as amended by the Lautenberg Amendments in 2016) required EPA to take expedited action to complete TSCA section 6(a) rules on certain PBTs.  In January 2021, EPA released final rules for decaBDE, PIP (3:1), and three other PBTs.  The final rules for decaBDE and PIP (3:1) generally prohibit their manufacture, processing, and use beginning in March 2021, though the rules contained phased-in prohibitions and exclusions for certain uses; EPA has extended certain phased-in prohibitions for PIP (3:1) multiple times since.

In light of new information and the Agency’s reinterpretation of the directive in TSCA section 6(h)(4) to “reduce exposures to the substance to the extent practicable,” EPA is proposing revisions to the final rules for decaBDE and PIP (3:1).  For decaBDE, the proposed revisions include:

  • Requiring a label on existing plastic shipping pallets containing decaBDE,
  • Requiring use of PPE for certain activities involving decaBDE,
  • Prohibiting releases to water during the manufacturing, processing, and commercial distribution of decaBDE and decaBDE-containing products,
  • Extending the current compliance extension for the processing and distribution in commerce of decaBDE-containing wire and cable insulation for use in nuclear power generation facilities, and
  • Requiring export notification for decaBDE-containing wire and cable for nuclear power generation facilities.

The proposed revisions to the PBT rule for PIP (3:1) include:

  • Narrowing the exclusion of prohibition for PIP (3:1) use in lubricants and greases to only include use in aerospace and turbine applications,
  • Replacing the exclusion from prohibition for motor and aerospace vehicle parts containing PIP (3:1) with phased-in prohibitions,
  • Excluding from prohibition the processing and commercial distribution of PIP (3:1) and PIP (3:1)-containing products for use in wire harnesses and circuit boards, and
  • Requiring PPE during manufacturing and processing of PIP (3:1).

In the proposed rule, EPA states that the Agency is not reconsidering the final rules for the other three PBTs–2,4,6-TTBP, HCBD, and PCTP–subject to final rules in January 2021.

According to EPA, decaBDE is a flame retardant that is used in textiles, plastics, adhesives, and polyurethane foam, and PIP (3:1) is a flame retardant, a plasticizer, and an anti-compressibility and anti-wear additive used in lubricants, hydraulic fluids, and in the manufacture of other compounds.

EPA Releases Final Guidance for Pesticide Submissions for New Outdoor Uses that Require ESA Reviews

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EPA has published the document Final Guidance for Pesticide Submissions for New Outdoor Uses that Require Endangered Species Act (“ESA”) Reviews. In October, the Agency requested public comment on the draft version of this document which was due to the Agency by October 16. In its press release regarding the guidance, EPA stated that the document will fulfill the requirements imposed upon it under the Pesticide Registration Improvement Act of 2022 (“PRIA 5”). Under PRIA 5 EPA must develop and issue guidance to registrants regarding analyses necessary to support the evaluation of potential adverse effects from new outdoor uses of pesticide products on ESA species and designated critical habitats. The draft guidance will apply to the following outdoor uses:

  • new uses of existing conventional pesticides
  • new uses of existing biocides
  • new conventional pesticide active ingredients
  • New uses of biocide active ingredients

The document does not detail any new requirements for applicants. Its purpose is to serve to assist applicants in addressing potential effects on ESA species for the types of new outdoor uses listed above. Many recommended actions include steps that applicants can take voluntarily in developing proposed mitigation efforts. These efforts include:

  • identifying the action area,
  • identifying routes of exposure to potentially affected ESA species,
  • performing initial special overlap analysis to identify where proposed new uses will overlap with critical habitats,
  • identifying mitigation measures (such as decreasing run-off by deploying soil binding agents) and
  • address the risk associated with all active ingredients

The Agency states that “if followed, these recommendations should expedite the review for new outdoor uses of existing conventional pesticides and biopesticide active ingredients under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and improve the efficiency of the overall ESA-FIFRA process.”

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

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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.

EPA Issues Draft Risk Evaluation for Flame Retardant TCEP

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EPA has preliminarily determined that tris(2-chloroethyl) phosphate (TCEP) presents an unreasonable risk to human health and the environment, according to its draft risk assessment of the flame retardant released on December 14, 2023.  Animal testing data revealed that exposure to TCEP may increase risk of kidney cancer and other cancers, and could harm neurological and reproductive systems, the draft states.

According to EPA, domestic production of TCEP has decreased by about 99 percent since 2014.  However, the agency notes that TCEP is still used in paints, coatings, and in certain aerospace applications, and that previously-manufactured products containing TCEP—such as fabrics, certain types of foam, and construction materials—may still be in use.  The draft also states that “TCEP may still be found in a wide range” of imported goods.

Because TCEP is mixed into materials rather than being chemically bonded, it can leach out of products, EPA said.  Infant and child exposure from mouthing consumer products containing TCEP was determined to present an unreasonable risk.  The agency also found unreasonable risk of health effects for breastfed infants, people who handle TCEP at work, people who inhale TCEP dust off consumer products, and people who eat TCEP-contaminated fish.

EPA determined that TCEP presents an unreasonable risk to the environment due to studies on chronic exposures in fish and sediment-dwelling organisms.  The draft identified a number of ways by which TCEP can enter the environment, including manufacturing processes, air emissions, and leaching from products and landfills.  Although TCEP is not considered bioaccumulative, it is persistent in the environment, EPA said.

The draft risk evaluation is open for public comment and will undergo peer review by independent scientific and technical experts starting in March 2024.  If EPA still concludes that TCEP presents an unreasonable risk after public comment and peer review, the Toxic Substances Control Act requires the agency to take steps to mitigate its risks.

EPA Orders Plastic Fluorination Company to Stop Producing PFAS

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Inhance Technologies LLC (“Inhance”) must stop producing PFAS substances created during its fluorination of high-density polyethylene plastic containers, according to two orders issued by EPA on December 1, 2023.

EPA first became aware of PFAS contamination in fluorinated plastic containers in late 2020.  In March 2022, EPA issued a Notice of Violation to Inhance for creating these PFAS in alleged violation of a significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) substances.  The Texas-based company submitted significant new use notices for nine such substances in December 2022 but has continued fluorinating containers nonetheless.

Three of these significant new use notices are addressed in the first order, which was issued under section 5(f) of the Toxic Substances Control Act (TSCA).  EPA determined that these substances—PFOA, PFNA, and PFDA—present an unreasonable risk due to their persistence, bioaccumulation, and toxicity that can only be prevented by prohibiting their manufacture.

The second order, issued under TSCA section 5(e), addresses the six remaining PFAS: PFuDA, PFDoA, PFTrDA, PFTeDA, PFHxDA and PFODA.  EPA determined that these substances may present an unreasonable risk, and the order prohibits their manufacture until certain testing be submitted to and evaluated by the Agency.

In response to the orders, which take effect February 28, 2024, Inhance stated that “the company will pursue all legal options to protect its customers, suppliers, and employees and to ensure the continued operations of this environmentally critical technology.”

The orders are likely to impact ongoing litigation between EPA and Inhance.  In December 2022, EPA sued Inhance for allegedly violating the LCPFAC SNUR.  Inhance has maintained that its fluorination process is legal, arguing that any PFAS present after fluorination are unintended impurities exempt from the SNUR.  More information on that case can be found in a previous Verdant Law blog post.

Fluorination, or the treatment of plastic with fluorine gas, makes containers less permeable.  According to an EPA press release, Inhance fluorinates up to 200 million containers per year.

EPA Finalizes TRI PFAS Reporting Rule

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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

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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

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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

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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

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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.