Pesticides, Chemical Regulation, and Right-to-Know Committee Report

In 2022 the Environmental Protection Agency (EPA) made progress in addressing some of its most challenging responsibilities under the Toxic Substances Control Act (TSCA) and the Federal Insecticide Fungicide and Rodenticide Act (FIFRA). This includes completing its rework of TSCA risk evaluations conducted under the Trump Administration and its first proposed risk management rule under the amended statute, acknowledging and starting to address the delays in reviewing new chemicals, developing a strategy to address the backlog of endangered species impact review obligations for pesticides, and nearing the end of the first cycle of pesticide registration reviews. EPA’s chemicals office also pursued a range of actions addressing per- and polyfluoroalkyl substances (PFAS), consistent with the Agency’s 2021 PFAS Strategic Roadmap and updated Roadmap goals.

I. Toxic Substances Control Act (TSCA)

A. New Chemicals Program and Significant New Use Rules

1. New Chemical Review

The longstanding backlog of TSCA section 5 premanufacture notice (PMN) reviews continued to grow in 2022. EPA cited inadequate funding and resources to meet the expanded new chemical review requirements of the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) as the main reasons for the backlog. The number of new PMNs and Low Volume Exemptions (LVE) submitted was down to 514, continuing a significant downward trend since the Lautenberg Amendments. EPA took a number of program implementation actions to help address the backlog, including public webinars highlighting common submitter errors that require EPA to rework risk assessments, and initiatives to streamline review of PMNs for bio-based or waste-derived chemicals, and mixed-metal oxides (MMOs), which are commonly used in the manufacture of electrical vehicle batteries. The Agency also launched a long term research initiative to modernize EPA’s approach to new chemical risk assessments. It is intended to include developing and implementing New Approach Methodologies (NAMs), updating approaches to using structural activity relationships (read-across) in risk assessment, and augmenting the range of models used in risk assessment to predict physical-chemical properties, fate, transport, exposure, and toxicokinetics of new chemicals.

The Agency made a number of policy changes that will impact new chemical review. EPA expanded the scope of individual risk assessments by discontinuing an historic policy of omitting small quantities of chemicals released to air or from landfills from its exposure and risk modeling. EPA revoked a 1980 policy that has allowed manufacturers (and their successors) to correct their submissions made to identify chemicals in commerce for the initial TSCA Inventory in certain excusable circumstances, such as correcting chemical identities based on information obtained by new technology.

EPA also issued two compliance advisories changing or clarifying interpretation of TSCA requirements. First, EPA issued a series of statements clarifying that chemical species incidentally produced in connection with fluorinating high density polyethylene (HDPE) barrels and not separated from the barrels were “byproducts,” and were not exempt as “impurities” or on any other basis under the Significant New Use Rule (SNUR) general provisions. Indeed, EPA commenced an administrative and later a civil enforcement action against a fluorinated barrel manufacturer for violating the principal PFAS categorical SNUR, seeking an injunction from further manufacture of the PFAS “byproducts.” EPA’s enforcement actions were followed by a citizen suit by environmental organizations under TSCA section 20(a) seeking similar injunctive relief against the barrel manufacturer. While this issue arose in the context of a specific PFAS SNUR, the general principle that such coincidentally produced substances may trigger SNUR notification requirements may have broader implications for a wide range of companies incidentally manufacturing or processing SNUR chemicals.

Without acknowledging any change in position, EPA also issued a compliance advisory confirming its current view that mixed metal oxides are viewed as single chemical entities and not mixtures for TSCA Inventory purposes. This statement of enforcement position arises from a longstanding controversy over the proper TSCA Inventory nomenclature for ceramics (such as many MMOs), and whether they may be represented on the Inventory as mixtures of individual metal oxides under a categorical Chemical Abstracts Service registration number (CASRN) as suggested by past EPA guidance, or must be listed individually on the Inventory.

Under EPA’s 2021 PFAS LVE Stewardship Program, companies voluntarily withdrew an additional twenty-two LVEs for short chain PFAS substances. A coalition of environmental organizations petitioned EPA to revoke approximately 600 remaining PFAS LVEs and low release and low exposure exemptions (LoREX).

Litigation continues between environmental NGOs and the Agency concerning the sufficiency and timing of EPA’s public disclosure of non-confidential section 5 new chemical notices. EPA’s motion for judgment on the pleadings for lack of standing remains pending. However, in the interim, EPA reported that it gathered and published non-confidential versions of all section 5 notices submitted in 2014 or later, and 3,900 section 8(e) substantial risk notices submitted in the period 2019 through late 2021 in its web-based ChemView application.

An industry coalition filed a petition under the Administrative Procedure Act seeking specific revisions to the 40 C.F.R. Part 720 Premanufacture Notice regulations intended to streamline and improve the PMN review process, and to conform those rules to the requirements of the Lautenberg Act amendments to section 5 of TSCA.

2. Significant New Use Rules

EPA finalized long-pending changes to the SNUR general provisions. Among other things, the amendments require employers to establish and use all feasible engineering and administrative controls to prevent occupational dermal and inhalation exposures before using personal protective equipment (PPE), update the Part B hazard communication requirements to align with current OSHA regulations and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and update SNUR respirator selection procedures to align with current OSHA and NIOSH regulations. The rule and preamble also address control of releases to water. Industry now may consider the effect of wastewater treatment to meet SNUR discharge concentration limitations in some cases. And the preamble clarifies EPA’s enforcement position concerning which inadvertent chemical releases are nevertheless deemed to be “predictable or purposeful” and therefore may trigger Significant New Use Notice (SNUN) requirements. EPA explained its view that “non-routine releases to water that are not due to emergency conditions are deemed “predictable or purposeful” and not exempt.

The Agency initiated a series of SNURs to support other TSCA actions. First, complementing the development of risk management rules under section 6 for High-priority chemicals completing the risk evaluation process, EPA signaled that it was preparing SNURs that would require submission of a SNUN before one could engage in any use of a High-priority chemical that had not been evaluated during the corresponding risk evaluation process. EPA plans to propose these SNURs for groups of High -priority substances, including for phthalates, flame retardants, and certain solvents. Complementing EPA’s broader PFAS Strategic Roadmap, EPA initiated development of SNURs for certain PFAS no longer in active commerce and listed as “Inactive” on the TSCA Inventory. EPA proposed SNURs for thirty-five PFAS for which TSCA section 5 consent orders had been issued following PMN review, but for which EPA had never issued a corresponding SNUR. The SNURs would designate as a significant new use any use not described in the corresponding PMN or 2020 Chemical Data Reporting (CDR) report and, where not contraindicated by CDR reporting, annual manufacturing greater than 2,500 pounds. In an atypical move, EPA also effectively proposed the addition of more protective exposure control requirements to chemicals already subject to a consent order by adding control terms in the SNURs that are not specified in the underlying orders, and making inapplicable the standard SNUR notification exemption for persons operating under a consent order.

B. Regulation of Existing Chemicals: Prioritization, Risk Evaluation, and Risk Management

1. EPA-Initiated and Manufacturer-Requested Risk Evaluations

EPA’s existing chemicals regulatory efforts in 2022 continued to be focused on addressing the perceived shortcomings of risk evaluation decision-making completed during the Trump administration. Key features of a new approach were announced in 2021 and included assuming no personal protective equipment is used when assessing exposure (the “baseline scenario”), conducting a screening assessment of general population exposures to air and water emissions in fenceline communities using modeling, and making single risk determinations for High- priority chemicals covering all uses rather than the use-by-use risk determinations used by the Trump Administration. EPA reopened the first ten risk evaluations completed by the Trump administration in 2020 and 2021 to make new risk determinations using these new principles. EPA issued a draft revised risk determinations for trichloroethylene (TCE) and completed revised risk evaluations for methylene chloride, cyclic aliphatic bromide cluster (HBCD), Pigment Violet 29, carbon tetrachloride, perchloroethylene (PCE), 1-Bromopropane, and n-Methylpyrrolidone (NMP). Final risk evaluations were due in December 2022 for each of the twenty chemicals designated as High- priority in December 2019, but EPA did not issue a draft risk evaluation for any of these. Work on these twenty evaluations continued to be significantly delayed while EPA focused resources on reworking risk evaluations for the first ten chemicals.

EPA for the first time proposed a section 6(a) risk management rule for a High- priority chemical that had been determined to present an unreasonable risk through the section 6(b) risk evaluation process – chrysotile asbestos. EPA proposed to address risks from the few remaining uses of chrysotile asbestos with a ban phased in over six months to two years, depending on the use. EPA considered and rejected controlling risk with new occupational exposure limits established under TSCA authority (Existing Chemical Exposure Limits or ECELs). Notably, EPA’s ECELs for asbestos would have been far more stringent than the Occupational Safety and Health Administration’s (OSHA) corresponding permissible exposure limit (PEL). As required by TSCA section 9, EPA also considered whether chrysotile asbestos risks could be adequately addressed by other federal agencies or under other statutes administered by EPA. EPA concluded that OSHA standards would be inadequate because they must be technologically and economically feasible, while TSCA standards do not. Similarly, EPA determined that other EPA authorities outside of TSCA would not be adequate because they do not address occupational exposure. Development of the proposed rule also was notable because EPA conducted environmental justice consultations in compliance with Executive Orders 12898 and 14008, including outreach to communities deemed to face greater risk of exposure to asbestos.

The proposed chrysotile asbestos rule and underlying risk determination did not address potential risks associated with ongoing use (and future disposal) of asbestos and asbestos impurities in products, such as construction materials. As required by the 2019 decision in Safer Chemicals, Healthy Families v. EPA, EPA initiated a separate risk evaluation for asbestos focused only on these legacy uses, including publishing a final risk evaluation scope.

EPA also published the final risk evaluation scope for the manufacturer-requested risk evaluation of octamethylcyclotetra-siloxane (D4). The final scope includes additional conditions of use identified by EPA and not by the manufacturers, and reflects EPA’s intent to assess risk without considering PPE and consider general population exposures for fenceline communities arising from facility air emissions and water discharges.

2. Persistent, Bioaccumulative, and Toxic (PBT) Chemicals

Similar to the concerns with Trump Administration risk evaluation decisions for High-priority chemicals, the Biden administration also is concerned with perceived shortcomings with of the Trump Administration’s risk management decisions under TSCA section 6(h) for five chemicals deemed to be persistent, bioaccumulative, and toxic (PBTs). The EPA confirmed its intent to revise the current partial bans for each of the five PBTs to further reduce exposures to the extent practicable. EPA also further extended the compliance date to October 31, 2024 for the ban on manufacture and distribution of phenol, isopropylated phosphate (PIP) (3:1) for use in articles and PIP (3:1)-containing articles. The further extension was deemed necessary to give manufacturers additional time to transition to substitute materials (or demonstrate the need for even further extensions), and to avoid significant disruption in supply chains in the interim.

C. Test Order Activity and Litigation

EPA issued a second round of TSCA section 4(a)(2) test orders for eight chemicals undergoing section 6(b) EPA-initiated risk evaluation, focused primarily on toxicity testing on sediment-dwelling organisms (i.e., chironomids) and terrestrial organisms (i.e., earthworms and birds). EPA has issued no test orders for eleven of the twenty substances currently under review.

Three of the new orders were challenged. The Vinyl Institute, Inc. filed suit in the U.S. Court of Appeals for the District of Columbia Circuit for review of the test order for 1,1,2-trichloroethane, challenging the sufficiency of the Agency’s assessment of need, required by TSCA section 4(a)(3), for an avian reproduction test. An industry consortium’s challenge to the trans-1,2-dichloroethylene (TDCE) test order also centered on the sufficiency of EPA’s demonstration of need for the order. In that case, the consortium had proposed to submit existing data in lieu of new testing to address a data gap identified by EPA. It filed suit to preserve its right to judicial review when EPA was unable to reach a conclusion about the adequacy of that data within the 60-day period for filing a petition for review. Lanxess sought review of EPA’s second test order for o-dichlorobenzene (ODCB), in part because it was not subject to the Order because TSCA section 4(b)(3)(C) limited EPA’s authority to require testing to persons currently manufacturing or processing a substance or intending to do so, and the petitioner had ceased manufacture and processing ODCB before the order was issued. EPA subsequently agreed to withdraw the order as against Lanxess on other grounds, and the case was dismissed without a decision on the legal defense. Subsequent to the suit, the Agency issued guidance explicitly confirming its legal position, reflected in the several orders, that it may properly issue TSCA section 4 orders to former manufacturers and processers of a substance.

In connection with its 2021 National PFAS Testing Strategy, EPA issued the first of twenty-four anticipated TSCA section 4(a)(2) test orders for certain PFAS chemicals selected as representative of a category of PFAS chemicals with similar structure and physical properties. The first order was directed to EPA-identified manufacturers of 6:2 fluorotelomer sulfonamide betaine (6:2 FTSB) and requires respondents to conduct a series of tests over seven years , including tests establishing certain physical properties, biosolubility, toxicokinetics, and inhalation toxicity. One of the respondents, National Foam, Inc., petitioned for review of the order in the U.S. Court of Appeals for the District of Columbia Circuit on the novel grounds that it processed the chemical only as part of a mixture and never processed 6:2 FTSB as a separate substance.

D. TSCA Section 8 Information Collection Rules

EPA proposed a TSCA section 8(a) one-time reporting rule for asbestos covering manufacture, import and processing over the prior four years, including asbestos in the form of an impurity, in mixtures and in articles.

The Agency convened a Small Business Advocacy Review Panel and prepared an Initial Regulatory Flexibility Analysis (IRFA) more fully assessing the likely costs of implementing its 2021 proposed TSCA section 8(a)(7) PFAS reporting rule. That rule, required by the National Defense Authorization Act for Fiscal Year 2020 (FY2020 NDAA), would require all manufacturers and importers of PFAS in any amount, at any concentration, in any product, in any year since 2011, to report a wide range of information on chemical identity, manufacture, processing, use, disposal, environmental and health effects, and worker exposure, by site, and by year back to 2011. EPA’s revised cost estimate for the program, as reflected in the IRFA , rose dramatically from $10.8 million to $875 million.

E. Other TSCA Regulatory Developments

EPA issued a supplemental proposed rule to increase fees for industry and EPA actions under TSCA sections 4, 5, 6, and 14. EPA proposed TSCA fee increases significantly greater than increases proposed in the last days of the Trump Administration. The large increase is derived from a new, much higher estimate of the total annual cost to EPA administering TSCA sections 4, 5, 6, and 14: $181 million, which is more than twice the $87.5 million estimated by EPA in 2021. If the proposed rule is adopted, fees for submitting a PMN, for example, would increase from $19,020 to $45,000, while fees shared among manufacturers for an EPA-initiated risk evaluation under section 6(b) would increase from $2,560,000 to $5,081,000 .

EPA proposed new procedures for asserting and substantiating Confidential Business Information (CBI) claims in TSCA submissions, including expanding electronic reporting requirements, procedures for maintenance and withdrawal of CBI claims, and internal procedures for reviewing and communicating with TSCA submitters about confidentiality claims. The proposal also would require companies to submit health and safety information to EPA using the Organisation for Economic Co-operation and Development (OECD) templates, if available. The Agency explained that using the templates should make CBI claims clearer and make it easier for EPA to share data across the Agency.

EPA addressed a number of rulemaking and other petitions. A coalition petitioned EPA under TSCA section 21 to perform human and environmental health and safety testing for polyvinyl alcohol (PVA/PVOH) as it is used in consumer-packaged goods. Among other things, PVA is used to make laundry and dishwasher detergent pods and sheets.

EPA denied a citizen petition requesting that EPA determine that the manufacture, processing, distribution in commerce, use, or disposal of greenhouse gas emissions, fossil fuels, and fossil fuel emissions presents an unreasonable risk of injury to health or the environment and initiated a TSCA section 6(a) risk management rulemaking. EPA found that the petition was insufficiently specific and that the petitioners did not meet their burden of establishing that it is necessary to issue a rule under TSCA section 6(a).

The U.S. District Court for the Northern District of California partially lifted its stay of a long-running suit challenging EPA’s 2017 denial of a TSCA section 21 petition seeking a TSCA section 6(a) risk management rule prohibiting the addition of fluoridation chemicals to drinking water. The stay was lifted to give plaintiffs access to draft National Toxicology Program (NTP) review studies of fluorine hazards and epidemiology that might be used in a new trial. EPA in turn moved to hold the case in abeyance until the NTP studies are in final form.

EPA initially denied the section 21 petition of a coalition of environmental organizations seeking a TSCA section 4 test rule for fifty-four PFAS “manufactured by The Chemours Company [] at its chemical production facility in Fayetteville, North Carolina.” The coalition filed suit in the U.S. District Court challenging the denial of the petition. EPA (under the Biden Administration) later reversed itself and granted the petition. However, EPA proposed to implement only a portion of the requested testing, following the path presented in its National PFAS Testing Strategy. The coalition viewed this as a partial grant and partial denial of its petition and filed an amended complaint seeking judicial review of both the original denial and EPA’s subsequent grant. EPA then moved to dismiss the suit on the grounds that the court has no jurisdiction to review the grant of a petition.

F. National Program Chemicals

EPA issued new guidance outlining suggested content for petitions to exempt particular laminated composite wood products from the formaldehyde emission standards scheduled to take effect in 2024. EPA also proposed to update references in the composite wood products regulation to the most current versions of several voluntary consensus standards concerning composite wood products.

Federal Insecticide Fungicide and Rodenticide Act (FIFRA)

A. Endangered Species Act (ESA) Consultations on Pesticide Registrations

In a significant change of approach, EPA announced that, going forward, before registering any new conventional pesticide active ingredient (AI), EPA first will make an effects determination for species listed or habitats designated under the ESA. EPA will seek the Fish and Wildlife Service’s (FWS) or the National Marine Fisheries Service’s (NMFS) (collectively, the Services) concurrence or initiate consultation before issuing a new AI registration. If a new AI could jeopardize listed species or adversely modify critical habitat (J/AM), EPA will require mitigation from the registrant. EPA also developed and released a workplan outlining its strategies for successfully implementing this approach going forward, including addressing the current backlog. EPA subsequently updated the workplan to address endangered species determinations in connection with registration review.

The Ninth Circuit partially vacated EPA’s interim registration review decision (IRRD) for glyphosate. The court found that the human health portion was not supported by substantial evidence, and, significantly, found the IRRD violated the ESA because it did not include a biological evaluation (BE). The court granted EPA’s request for voluntary remand without vacatur of the ecological portion of the risk assessment, but EPA was unable to meet the court’s deadline to complete a new analysis and withdrew the IRRD.

The Ninth Circuit partially granted a petition challenging EPA’s approval of new uses of sulfoxaflor, finding that EPA failed to make a required effects determination under the ESA and failed to provide the notice and comment required by FIFRA. The court declined to vacate the registrations, however, because doing so could harm the environment and would disrupt agriculture. Instead, the court directed EPA to fulfill its obligations within 180 days.

The D.C. Circuit issued a writ of mandamus ordering EPA to complete an ESA effects determination for cyantraniliprole within 180 days. EPA had been ordered by the court in 2017 to complete the analysis, but had failed to take significant action.

Other ESA-FIFRA cases were resolved by settlement. In a set of cases brought after EPA approved five new AIs without completing BEs, the parties reached a settlement in which the court will hold the cases in abeyance until agreed-upon deadlines for EPA to complete BEs. The parties to a lawsuit regarding EPA’s failure to consult the Services prior to registering the new AI trifludimoxazin also reached a settlement. The registrant voluntarily canceled the trifludimoxazin registrations with plans to reapply, and EPA will evaluate the applications as applications for a new AI, subject to EPA’s new workplan. Finally, EPA settled a dispute surrounding its FIFRA registrations of acetamiprid, dinotefuran, and imidacloprid products without ESA reviews. In 2021, the parties reached a partial settlement regarding imidacloprid. Consistent with that agreement, EPA published its final BE for imidacloprid in June 2022. In March 2022, the parties settled the remaining claims, requiring BEs for acetamiprid and dinotefuran by October 2024.

In addition, EPA published final BEs for clothianidin and thiamethoxam and published draft BEs for sulfoxaflor and inpyrfluxam. After incorporating conservation measures, FWS published a final Biological Opinion (BiOp) for malathion, finding no J/AM. NMFS revised its 2017 BiOp for malathion, chlorpyrifos, and diazinon; after EPA and the registrants agreed to mitigation measures, NMFS issued a final BiOp finding no J/AM.

B. Pesticide Registration Improvement Act (PRIA) Developments

The Pesticide Registration Improvement Act of 2022 (PRIA 5) became law as part of the Consolidated Appropriations Act of 2023 (Act). PRIA 5 extends EPA’s authority to collect registration service fees under FIFRA § 33 until September 30, 2027 and extends the subsequent phaseout of EPA’s authority until September 30, 2029. PRIA 5 also amended FIFRA § 3(f) to establish new bilingual (English-Spanish) labeling requirements for pesticides; extended and modified EPA’s authority to collect registration maintenance fees under FIFRA § 4(i); extends the ban on tolerance fees in section 408(m)(3) of the Federal Food, Drug, and Cosmetics Act until September 30, 2027; extensively amended FIFRA § 4(k) establishing and governing the Reregistration and Expedited Processing Fund; and mandated the posting on a single EPA webpage certain aggregated information on pesticide regulation under FIFRA. Separately, the Act itself extended the registration review deadline in FIFRA § 3(g) until October 1, 2026 and required that each IRRD include measures, where applicable, to reduce the effects of the relevant pesticide on species listed or habitats designated under the ESA.

C. Pesticide Registration Review Status Update

EPA released a status update on the Agency’s progress completing registration reviews for the 726 conventional, biopesticide, and antimicrobial pesticide active ingredients registered before October 1, 2007. By law, EPA was to complete all of these reviews no later than October 1, 2022; however the status update reported that the Agency completed only 151 final registration review decisions (or 21% of the total number of pesticides under registration review). EPA also reported that it had completed 685 draft risk assessments (or 94% of the total); 633 proposed interim or proposed final registration decisions (or 87% of the total); and issued 431 interim decisions (or 60% of the total). Of the 582 interim or final decisions issued at the time of the update, 140 review cases resulted in cancellation of some or all pesticidal uses. In total, there are still 144 pesticides out of the 726 for which EPA has issued neither an interim nor final registration review decision. EPA currently projects registration review activities running through FY 2026.

EPA moved to suspend a registration under FIFRA section 3(c)(2)(B)(iv) due to the sole registrant’s alleged failure “to take appropriate steps to secure the data” required by a 2011 data call-in. The matter was set for hearing, but before the hearing, the ALJ granted EPA’s motion for accelerated decision on the grounds that there were no genuine issues of material fact. That decision was reversed by EPA’s Environmental Appeals Board (EAB), which held that the proper test was not whether the registrant had submitted the required data, but, as required by section 3(c)(2)(B)(iv), whether the registrant had “‘take[n] the appropriate steps to secure the data required,’” which could include, for example, consideration of efforts to secure data call-in waivers.

D. Antimicrobial Product Policy

In 2022, EPA activated its 2016 “Emerging Viral Pathogen” guidance (EVP Guidance) for two additional viral pathogens: Ebola virus and monkeypox virus. EPA first activated the EVP guidance in January 2020 at the start of the COVID-19 pandemic. The policy reflected in the EVP Guidance allows antimicrobial pesticide manufactures to make specific limited off-label efficacy claims for a limited time against designated emerging pathogens without organism-specific efficacy data or label amendments.

EPA registered the first antimicrobial pesticide product approved to make claims for use as an air sanitizer against bacteria and viruses. The Agency also revised and finalized efficacy test methods and guidance to support label claims for residual efficacy on hard, non-porous surfaces. The test method anticipates only two types of products – disinfectants with residual efficacy and supplemental residual antimicrobial products (e.g., antimicrobial paints or coatings) that do not support disinfection claims and are intended only as a supplement to standard disinfection practices.

EPA again extended the life of a temporary amendment to Pesticide Registration Notice (PRN) 98-10 that allows registrants of products approved to make emerging pathogen efficacy claims against SARS-CoV-2 to make minor product formulation changes (active ingredients sourced from commodity chemicals) without first obtaining formal Agency approval. The March 15, 2023 termination deadline is intended to give the Agency adequate time to review and approve as permanent those formulation or manufacturing amendments submitted during the period of the temporary amendment.

E. PFAS Actions Under FIFRA

Due to potential hazard concerns, EPA removed twelve PFAS chemicals from the Agency’s list of approved inert ingredients; none were in active use. EPA is investigating whether any approved active ingredients may be classified as PFAS and advised that it would view any level of PFAS impurities discovered in a pesticide product to be potentially toxicologically significant and reportable under FIFRA section 6(a)(2). EPA released study data from its evaluation of the potential for incidentally produced PFAS to leach into liquid pesticides from fluorinated high-density polyethylene (HDPE) containers used to store and transport pesticide products and reported that PFAS could leach into both solvent and water-based formulations from such containers.

F. Action on Pesticide Regulatory Petitions Submitted to EPA

EPA denied a 2017 petition to exclude pesticide-treated seeds from the scope of FIFRA’s treated articles exemption as unnecessary because EPA assures proper seed treatment instructions during the registration process of each seed treatment pesticide. Nonetheless, EPA stated in the denial letter that it would explore, through an advanced notice of proposed rulemaking, whether a rule governing the distribution of unregistered treated seeds is warranted.

The U.S. Court of Appeals for the Ninth Circuit vacated EPA’s July 21, 2020 denial of a 2009 petition to cancel all pet uses of tetrachlorvinphos (TCVP) because the denial was not supported by substantial evidence and ordered EPA to issue a new decision within 120 days. In response to the order, EPA partially granted and partially denied the 2009 petition. EPA found that there are unacceptable risks from TCVP pet collars for children and stated its intent to draft a proposed Notice of Intent to Cancel TCVP pet collar registrations, subject to reconsideration in light of data expected from registrants from further pending exposure studies.

G. Endocrine Disruptor Screening Program

A coalition of non-profit organizations filed a complaint under section 702 of the Administrative Procedures Act alleging that EPA had failed to develop and implement an endocrine screening program for all pesticide chemicals by 1999 as required by the Food Quality Protection Act and seeking injunctive relief to compel EPA to complete the testing under court supervision.

H. Agricultural Worker Protection Standard

EPA published a notice confirming that, due to a court-ordered stay of the 2020 amendments to the application exclusion zone (AEZ) requirements of the Agricultural Worker Protection Standard (WPS) (codified at 40 C.F.R. pt. 170), the currently applicable and enforceable AEZ requirements are those that were in effect immediately before the 2020 amendments. These were issued in 2015 and are available in the Federal Register. Proposed amendments to the stayed 2020 AEZ regulations were circulated to the Secretary of the USDA in late 2022 ahead of a public proposal.

I. State Pesticide Law Developments of National Significance

In 2020, the Eastern District of California granted summary judgment for industry plaintiffs alleging that the cancer warning required by California’s Proposition 65 for the herbicide glyphosate violated the First Amendment. The court permanently enjoined the Proposition 65 warning requirement for glyphosate. The Attorney General of California appealed the decision to the Ninth Circuit. However, those proceedings have been held in abeyance. At the same time, the California Office of Environmental Health Hazard Assessment (OEHHA) developed a new safe harbor warning for glyphosate that might satisfy the requirements of both Proposition 65 and the First Amendment. OEHHA’s new glyphosate safe harbor warning regulation was promulgated on September 1, 2022. The Ninth Circuit appeal remains undecided.

In Carson v. Monsanto Co., a glyphosate personal injury case, a panel of the Eleventh Circuit Court of Appeals reversed a district court decision, holding that state duties to warn of alleged pesticide health hazards that are inconsistent with approved FIFRA labeling are preempted by FIFRA. The Eleventh Circuit granted Monsanto’s petition for rehearing en banc, which vacates the prior opinion and stays the mandate.

The Maine Legislature amended the Maine Pesticide Control Act to prohibit the distribution in Maine of either a pesticide that has been contaminated by PFAS or, beginning January 1, 2030, a pesticide that contains intentionally added PFAS unless the Maine Department of Environmental Protection has determined by rule that the use of PFAS in the product is currently unavoidable.

Emergency Planning And Community Right-To-Know Act (EPCRA)

EPA issued serval amendments to the Toxics Release Inventory (TRI) reporting requirements, including an amended definition of “parent company,” which now refers to the highest-level U.S. company in a corporate family, a requirement to report the identity of a foreign parent under certain conditions, and provisions to assure uniform naming conventions for parent companies. In a separate proceeding, EPA updated the list of North American Industry Classification system (NAICS) codes subject to reporting under TRI to reflect NAICS revisions by the Office of Management and Budget.

EPA added twelve chemicals to the TRI list of reportable substances following rulemaking initiated in response to a 2014 petition by the Toxics Use Reduction Institute. Prompted by litigation from the proponents, EPA issued a supplemental notice of proposed rulemaking to add the diisononyl phthalate (DINP) category to the TRI reporting list.

EPA took two actions under TRI respecting PFAS. By direct final rule, EPA added five additional PFAS substances to the TRI list that were determined to meet the automatic TRI listing criteria in the FY2020 NDAA. EPA also proposed to designate all 180 PFAS added so far to the TRI list by the FY2020 NDAA as ‘Chemicals of Special Concern.’ This designation would make inapplicable an exemption for reporting to customers de minimis quantities of TRI substances present in products as impurities, and disallow reporting the listed PFAS using the abbreviated TRI reporting format (Form A).

Biotechnology Developments

EPA registered a quintuple-stack genetically engineered corn insect pest plant-incorporated-protectant product that includes a double-strand RNA mode of action. EPA amended the FIFRA section 5 Experimental Use Permit for trial releases of the genetically engineered OX5034 Aedes aegypti mosquito. EPA’s action extends the duration of the OX5034 Aedes aegypti Experimental Use Permit to April 30, 2024 and expands authorization for releases to four counties in California.

The U.S. Animal Plant Health Inspection Service (APHIS) issued its first Regulatory Status Review (RSR) determination for a genetically engineered food crop under its 2020 amended 7 C.F.R. Part 340 regulation, which replaced the former petition for determination of nonregulated status process. The APHIS RSR determination concerned a tomato plant that is genetically engineered to express increased flavonoid content (hence its unique purple color). APHIS released for public comment a draft environmental impact statement (DEIS) and draft plant pest risk assessment (PPRA) for a genetically engineered American chestnut variety that can coexist with the fungus that causes chestnut blight and is intended to restore the functionally extinct American chestnut to its natural range.

In response to a court decision ordering additional Endangered Species Act (ESA) and NEPA analyses, the U.S. Food and Drug Administration (FDA) prepared and released for public comment a draft amended Environmental Assessment (EA) for the AquaBounty genetically engineered salmon. FDA previously had made a “no effect” determination for producing and rearing the AquaBounty salmon.

In an action intended to have long-term, significant beneficial effects on the development and expansion of biotechnology in the U.S., President Biden signed Executive Order 14081, Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.

 State Chemical Control and Disclosure Regulation

In 2022, at least six states enacted new laws that restrict PFAS in products. California passed laws that prohibit distribution or sale of cosmetic products containing intentionally added PFAS beginning January 1, 2025, and restrict the amount of PFAS in “textile articles” beginning in 2025. New Colorado legislation phases in prohibitions on a wide range of PFAS-containing products, starting in January 2024 with carpets and rugs, fabric treatments, food packaging, juvenile products, and oil and gas products. A Hawaii law prohibits food packaging with intentionally added PFAS and restricts use of PFAS-containing Class B firefighting foam starting in 2024. Maryland’s new law prohibits or restricts PFAS-containing firefighting foam, rugs and carpets, and food packaging. Ohio prohibits use of PFAS-containing Class B firefighting foams for training or testing purposes. Rhode Island enacted a law that will prohibit sales of food packages containing intentionally added PFAS beginning on January 1, 2024.

Both Delaware and New York enacted laws prohibiting the sale of, inter alia, upholstered furniture containing specified flame-retardant chemicals. Initial reports of flame-retardant chemicals in enclosures or stands for electronic displays were required in New York by December 31, 2022.