By James V. Aidala and Barbara A. Christianson

On March 13, 2023, the U.S. Environmental Protection Agency (EPA) issued a proposed rule that would update the pesticide Application Exclusion Zone (AEZ) requirements under the 2015 Agricultural Worker Protection Standard (WPS). 88 Fed. Reg. 15346. The proposed rule is available at EPA-HQ-OPP-2022-0133, and comments on the proposed rule are due on or before May 12, 2023.

Application Exclusion Zone

According to EPA’s press release, the WPS regulations offer protections to over two million agricultural workers and pesticide handlers who work at over 600,000 agricultural establishments. In 2015, EPA made significant changes to the standard to decrease pesticide exposure among farmworkers and their family members.

Among the changes, the revised standard includes a new provision requiring agricultural employers to keep workers and all other individuals out of the AEZ area during outdoor pesticide applications. The AEZ is the area surrounding an ongoing pesticide application that people must not enter to avoid exposure. EPA states that an AEZ moves with the equipment during applications to protect farmworkers and bystanders that could be contacted by pesticides.

In 2020, EPA published a rule specific to the AEZ requirements, limiting the applicability of the protections to the agricultural employer’s property and shrinking the AEZ size from 100 feet to 25 feet for some ground-based spray applications. Prior to the effective date of the 2020 AEZ Rule, petitions were filed in the U.S. District Court for the Southern District of New York (SDNY) and in the U.S. Second Circuit Court of Appeals challenging the 2020 Rule. The SDNY issued an order granting the petitioners’ request for a temporary restraining order. As a result, the 2020 AEZ Rule has not gone into effect, and the AEZ provisions in the 2015 WPS remain in effect.

EPA states that it determined the provisions in the 2020 AEZ Rule weakened protections for farmworkers and nearby communities from pesticide exposure and should be rescinded to protect the health of farmworkers, their families, and nearby communities.

Proposed Changes and Flexibilities

EPA is proposing to reinstate several provisions from the 2015 WPS, including:

• Applying the AEZ to:
  • Beyond an establishment’s boundaries; and
  • When individuals are within easements (such as easement for utility workers to access telephone lines).
• Establishing AEZ distances for ground-based spray applications of:
  • 25 feet for medium or larger sprays when sprayed from a height greater than 12 inches from the soil surface or planting medium; and
  • 100 feet for fine sprays.

Additionally, EPA is proposing to retain two provisions in the 2020 AEZ Rule that it believes are consistent with the intent of the 2015 WPS AEZ requirements and, according to EPA, are supported by information available that provides more clarity and flexibility for farming families. EPA proposes to retain:

• A clarification that suspended pesticide applications can resume after people leave the AEZ; and
• An “immediate family exemption” that allows only farm owners and the farm owners’ immediate family to remain inside enclosed structures or homes while pesticide applications are made, providing family members flexibility to decide whether to stay on-site during pesticide applications, rather than compelling them to leave even when they feel safe remaining in their own homes. 

Commentary

The 2015 WPS rule made significant changes and enhancements to the original 1992 WPS program and represented years of review and consideration of significant changes to the earlier rules. For the most part, by the end of that rule-gestation process, most changes were not considered controversial even as various stakeholders criticized or were dissatisfied by the final rule. Nonetheless, as the Trump Administration arrived in 2017, it considered revisions to the 2015 WPS rule in three areas: the minimum age of workers, the ability for a worker to designate a third-party representative to have the right to review application records if there was an inquiry related to a possible pesticide-related injury, and the AEZ provisions.  During this time that the Trump Administration considered and proposed changes, reauthorization of the pesticide industry fee law, the Pesticide Registration Improvement Act (PRIA), was moving through Congress. Proposed to be part of the 2018 Farm Bill, the PRIA reauthorization legislation was held up by Senator Udall (D-NM) over concerns about what he considered changes that would unacceptably weaken the 2015 WPS program.

This part of the saga came to an end when Senator Carper (D-DE), as Chair of the Senate Environment Committee, exchanged letters with the Trump Administration that promised no changes to the WPS requirements except for consideration of the AEZ provisions in exchange for allowing certain EPA appointee nominations to be considered for a confirmation vote.  This is worth noting since it was an explicit exchange of correspondence and not a more typical “informal” agreement between Administrations and Senators regarding confirmation votes. Eventually, the Trump Administration proposed and eventually issued only revisions to the AEZ requirements to, according to statements at the time, clarify and simplify the 2015 rule provisions.  It is those revisions that are now being changed in this 2023 rule.

In the end, these 2023 revisions mostly revert the AEZ requirements back to the 2015 regulation requirements. They do include some additional elements of the 2020 changes to respond to stakeholder concern elements of the provisions to clarify more precisely how to protect bystanders.  As a result, these regulations continue to implement two of the declared priorities of the Biden Administration: (1) increased emphasis on environmental justice concerns; and (2) to review and likely reverse decisions made by the Trump Administration considered to be not sufficiently protective and/or not sufficiently justified by the underlying factual basis relied upon by the previous Administration.

By Lisa R. Burchi and Barbara A. Christianson

On February 22, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced that it will co-host a virtual public meeting with the U.S. Food and Drug Administration’s (FDA) Center of Veterinary Medicine (CVM) on March 22, 2023. As stated in our February 17, 2023, blog, EPA and FDA are considering how best to update their respective oversight responsibilities for specific products in an efficient and transparent manner and in alignment with each agency’s expertise. According to EPA, the purpose of the comment period and virtual public meeting is to obtain feedback from stakeholders on ideas for modernizing EPA’s and FDA’s approach to product oversight.

EPA also has opened a docket for the agencies to receive comments on their current approach to the oversight of various products regulated as either pesticides by EPA or new animal drugs by FDA, with a focus on parasite treatment products applied topically to animals and in genetically engineered pest animals for use as pest control tools. EPA posted to the docket, and is requesting comments on, a document entitled, “WHITEPAPER: A Modern Approach to EPA and FDA Product Oversight,” (Whitepaper) which describes the current challenges and highlights the potential benefits of a modernized approach to oversight of these products. The Whitepaper is available at EPA-HQ-OPP-2023-0103, and comments on the Whitepaper are due on or before April 24, 2023.

In the Whitepaper, EPA focuses on two particular product types:

• Products administered topically to animals (e.g., flea and tick collars): EPA states that the “agencies have historically determined oversight for products topically administered to animals to treat fleas and ticks based on whether the chemical is systemically absorbed into the bloodstream (FDA oversight) or remains on the skin (EPA oversight).” Based on new understandings that many of these topically administered products regulated by EPA are systemically absorbed into the bloodstream as well as agreement by the agencies that FDA is better equipped to evaluate and monitor products topically administered to animals, the agencies are considering the transfer of approximately 600 topically administered products for external parasites on animals currently regulated by EPA to FDA.
• Genetically engineered pest animals (e.g., mosquitoes genetically engineered to control the mosquito population in the environment): EPA states a new approach can “provide the agencies with more flexibility to update and align their regulatory oversight of relevant products consistent with each agency’s mission and expertise.” No specific proposal is offered, although EPA notes that it “may need resources to expand its existing biotechnology program for products to control populations of pest animals and clarify the program’s approach to meet the needs of this growing industry.”

EPA announced that registration for the virtual public meeting is available and closes at 11:59 p.m. (EDT) on March 15, 2023. Requests for oral presentations must be made by March 15, 2023. Comments can be submitted in regulations.gov under docket EPA-HQ-OPP-2023-0103 until April 24, 2023. To register to attend the public meeting, visit https://www.eventbrite.com/e/547810324427.

Additional information is available at:

• Virtual Public Meeting: FDA and EPA Product Oversight
• Federal Register Notice
• Whitepaper: A Modern Approach to EPA and FDA Product Oversight

Commentary

Stakeholders are urged to review the information EPA has made available and consider commenting upon these proposed changes and potentially other EPA-FDA jurisdictional issues. The current focus on products administered topically to animals may seem narrow, but there are broader implications both for this category and for other EPA-FDA jurisdictional issues. It is unclear, for example, if the agencies have sufficiently considered EPA’s expertise in evaluating risks to the environment that may be at issue for many products administered topically to animals, as these products are not limited to flea and tick collars as described in the Whitepaper. Besides this one proposal to transfer jurisdiction for these products from FDA to EPA, there are few concrete details or proposals, leaving open the possibility to submit comments to the agencies regarding other areas where industry has struggled to determine which agency has authority over certain products, components, and devices.

By Lisa R. Burchi and Barbara A. Christianson

On February 15, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) and the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) announced plans to seek public input on the best approaches for updating their respective oversight responsibilities for specific products. EPA states the goal is to determine responsibilities in an efficient and transparent manner and in alignment with each agency’s expertise, thereby improving protection of human, animal, and environmental health.

EPA and FDA will hold a joint virtual public meeting on March 22, 2023, to provide information and receive public comment on the agencies’ current approaches for the oversight of various products regulated as either pesticides or new animal drugs. EPA and FDA state that members of the public will have the opportunity to comment during the meeting, and a docket will be available for the submission of written comments.

As background, EPA and FDA currently determine regulatory oversight of pesticides and new animal drugs based on the rationale described in a Memorandum of Understanding (MOU) between the agencies signed in 1971 and revised in 1973. Since that time, pesticide and animal drug technologies, and both agencies’ understanding of these technologies, have evolved. Examples provided include the following:

• Parasite treatment products applied topically to animals are regulated by EPA if they remain on the skin to control only external parasites (e.g., fleas, ticks) and by FDA if they are absorbed systemically into the bloodstream to control internal parasites (e.g., intestinal worms). The agencies state they now understand that many of the topically administered products currently regulated by EPA may not remain on the skin and are instead absorbed into the bloodstream. EPA and FDA are thus questioning the current approach and potentially different safety concerns.

• Genetically engineered (GE) pest animals, which are gaining interest as a pest control tool, were not envisioned 50 years ago when the original regulatory approach was developed. As agreed in the 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products, EPA and FDA have considered how to update their respective responsibilities with the goal of developing an efficient, transparent, and predictable approach for overseeing GE insects and other pest animals. Recently, Executive Order 14081, issued September 12, 2022, further directed the agencies to improve the clarity and efficiency of the regulatory process for biotechnology products, underscoring the need for continued coordination between the agencies on biotechnology.

In its notice, EPA acknowledges that the current approach to determining whether EPA or FDA is the appropriate regulator of certain products “does not effectively reflect or accommodate scientific advancement, and it has become clear in some cases that the current approach has resulted in misalignment between product characteristics and the agency better equipped to regulate the product.” EPA states further that “[a] modernized approach would ensure that the oversight of these products better aligns with each agency’s expertise, accounts for scientific advancement, avoids redundancy, better protects animal health and safety, and improves regulatory clarity for regulated entities, animal owners, veterinarians, and other stakeholders.”

Additional information about how to participate in the public meeting, including more detailed information describing challenges with the current approach, and how to submit public comments, will be posted on both FDA’s and EPA’s websites.

Commentary

The MOU at issue is outdated and presents considerable challenges for companies trying to determine the legal and regulatory construct for certain products. This notice thus is a significant development and potential opportunity to address numerous issues with the current jurisdictional divide between EPA and FDA. EPA has provided some clear examples where updated policies and approaches will be beneficial, but there are many more products to be considered. There also are other jurisdictional questions between EPA and FDA for other products that do not appear to be part of the current initiative, including antimicrobial products and medical/pesticide devices. The process being initiated now has the potential to provide much needed clarity for certain products and potentially pave the way for the agencies to consider further public input beyond the scope of the current notice.

By Barbara A. Christianson

On January 13, 2023, the U.S. Environmental Protection Agency (EPA) announced it is notifying pesticide registrants that EPA will send supplemental invoices to reflect the new annual pesticide registration maintenance fee for fiscal year (FY) 2023. To meet new statutory requirements in the Pesticide Registration Improvement Act of 2022 (PRIA 5), which was signed into law on December 29, 2022, the revised fee for FY 2023 for each registered pesticide product will be $4,875, increased from the $3,400 level specified in the EPA invoices provided in early December 2022.

According to EPA, PRIA 5 directs EPA to collect, to the extent practicable, an average amount of $42 million in pesticide registration maintenance fees annually for FYs 2023-2027. The previous collection target for FY 2023 under the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) was $31 million. Additionally, EPA notes that maximum payment caps and small business caps are increased in PRIA 5 and will be reflected in the forthcoming reinvoicing.

EPA states that all registrants with FIFRA Section 3 and Section 24(c) pesticide product registrations will receive an e-mail to notify them of this change. Registrants will need to access their product filing forms, pay any outstanding portion of the revised maintenance fees, and return completed documents to EPA. EPA instructs that if a company has already made payment to EPA in response to the earlier invoicing, the company will need to pay the difference between that initial payment and the amount owed under the supplemental invoicing. As PRIA 5 was enacted following EPA’s initial invoicing and shortly before the statutory payment deadline of January 17, 2023, EPA states it understands that registrants may encounter difficulties with timely payment of appropriate FY 2023 maintenance fees but encourages registrants to submit the required fee and form to EPA as soon as possible after the supplemental invoicing. EPA also encourages registrants to reach out to it with any .(JavaScript must be enabled to view this email address).

Registration is now open for the “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2023” webinar on January 31, 2023, 11:00 a.m. - 12:00 p.m. (EST).

• TSCA in 2023
  • Final rules for mitigating risks identified in EPA risk assessments
  • Proposed rules for mitigating risks identified in EPA risk assessments
  • Risk evaluations -- assumptions and methods
  • Test orders to impose chemical testing requirements
  • New chemicals update on premanufacture notice (PMN) issues
• Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in 2023
  • Congressional renewal of Pesticide Registration Improvement Act (PRIA) (registration fee program) for an additional five years
  • Endangered Species Act (ESA) program plans and progress
  • Program priorities for 2023, including environmental justice, registration review deadlines, staffing and budget, and possible 2023 Farm Bill actions

By Heather F. Collins, M.S.

The March 1, 2023, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2022 reporting year is fast approaching. Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7(c)(1) (7 U.S.C. § 136e(c)(1)), “Any producer operating an establishment registered under [Section 7] shall inform the Administrator within 30 days after it is registered of the types and amounts of pesticides and, if applicable, active ingredients used in producing pesticides” and this information “shall be kept current and submitted to the Administrator annually as required.”

Reports must be submitted on or before March 1 annually for the prior year’s production. The report, filed through the submittal of EPA Form 3540-16: Pesticide Report for Pesticide-Producing and Device-Producing Establishments, must include the name and address of the producing establishment; and pesticide production information, such as product registration number, product name, and amounts produced and distributed. The annual report is always required, even when no products are produced or distributed.

EPA has created the electronic reporting system to submit pesticide-producing establishment reports using the Section Seven Tracking System (SSTS). Users will be able to use SSTS within EPA’s Central Data Exchange (CDX) to submit annual pesticide production reports. Electronic reporting is efficient, saves time by making the process faster, and saves money in mailing costs and/or courier delivery and related logistics. EPA is encouraging all reporters to submit electronically to ensure proper submission and a timely review of the report.

Links to EPA Form 3540-16, as well as instructions on how to report and how to add and use EPA’s SSTS electronic filing system, are available below.

• EPA Form 3540-16: Pesticide Report for Pesticide-Producing and Device-Producing Establishments;
• Instructions for Completing EPA Form 3540-16 (available within the ZIP file); and
• Electronic Reporting for Pesticide Establishments.

Further information is available on EPA’s website.

By James V. Aidala and Dennis R. Deziel

On December 14, 2022, the U.S. Environmental Protection Agency (EPA) announced the removal of 12 chemicals from the current list of non-food inert ingredients approved for use in pesticide products because the inert ingredients have been identified as per- and polyfluoroalkyl substances (PFAS) and are no longer used in any registered pesticide product. 87 Fed. Reg. 76488. On September 13, 2022, EPA published a proposal to remove the 12 chemicals from the list of approved inert ingredients. In response to EPA’s request for comments, no specific information regarding those 12 chemical substances or any products that may include them was provided to EPA.

EPA is removing the following 12 chemicals from the current list of inert ingredients approved for use in pesticide products:

• 2-Chloro-1,1,1,2-tetrafluoroethane (Chemical Abstracts Service Registry Number® (CAS RN®) 2837-89-0);
• α-(Cyclohexylmethyl)-ω-hydropoly(difluoromethylene) (CAS RN 65530-85-0);
• Dichlorotetrafluoroethane (CAS N 1320-37-2);
• Ethane, 1,1,1,2,2-pentafluoro- (CAS RN 354-33-6);
• Hexafluoropropene, polymer with tetrafluoroethylene (CAS RN 25067-11-2);
• Montmorillonite-type clay treated with polytetrafluoroethylene (no CAS RN);
• Poly(difluoromethylene), α-chloro-ω-(1-chloro-1-fluoroethyl) (CAS RN 131324-06-6);
• Poly(difluoromethylene), α-chloro-ω-(2,2-dichloro-1,1,2-trifluoroethyl)- (CAS RN 79070-11-4);
• Poly(difluoromethylene), α-(2,2-dichloro-2-fluoroethyl)-, ω-hydro- (CAS RN 163440-89-9);
• Poly(difluoromethylene), α-fluoro-ω-[2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl]- (CAS RN 65530-66-7);
• Poly(oxy-1,2-ethanediyl), α-hydro-ω-hydroxy-, ether with α-fluoro-ω-(2-hydroxyethyl)poly(difluoromethylene) (1:1) (CAS RN 65545-80-4); and
• Propane, 1,1,1,2,3,3,3-heptafluoro- (CAS RN 431-89-0).

EPA states, in the PFAS Strategic Roadmap to address PFAS, it is removing these chemicals from the inert ingredient list to prevent the introduction of these PFAS into pesticide formulations without additional EPA review. This is in line with EPA’s strategic roadmap to address PFAS.

According to EPA, once an inert ingredient is removed from the list, any proposed future use of the inert ingredient would need to be supported by data, which may include studies to evaluate potential carcinogenicity, adverse reproductive effects, developmental toxicity, and genotoxicity, as well as data on environmental effects. The data must be provided to and reviewed by EPA as part of a new inert ingredient submission request.

The final notice and information on inert ingredients approved for use in pesticide products is available here.

Additional information on EPA’s action on PFAS in pesticide containers is available here.

Commentary

EPA’s final removal of these ingredients from the current list of approved inert ingredients list is not surprising, although it raises important process questions that should be watched closely in future EPA Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) actions. The removal action helps EPA meet its political commitment related to PFAS consistent with the PFAS Roadmap, and as EPA states itself, the 12 PFAS that are the subject of the notice are no longer used in any registered pesticide products. Predictably, public comments focused on general risks of PFAS and not directly on EPA’s action related to inert ingredients listing removal. It is a win for EPA related to its commitment to take action to limit PFAS.

The process EPA used to remove these 12 chemicals from the list of inert ingredients is noteworthy and potentially concerning. EPA presented no risk-based evidence for this regulatory action and instead relied on a class-based aggregation of a subset of approved inert ingredients. It will be important to continue to monitor this issue.

By Heather F. Collins, M.S.

The January 17, 2023, deadline for payment of the U.S. Environmental Protection Agency’s (EPA) annual maintenance fee for pesticide registrations is approaching. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A) requires everyone who holds an active or suspended pesticide registration granted under FIFRA Sections 3 and 24(c) (special local needs) to pay an annual maintenance fee to keep the registration in effect. The maintenance fee requirement does not apply to supplemental distributor registrations, which are identified by a three-element registration number.

EPA states that entire process remains electronic in 2023. EPA will not send maintenance fee information by mail again this year. The instructions, maintenance fee filing form, fee tables, and product listings grouped by company numbers are available to download on EPA’s website. When completed, the filing submission should be e-mailed to .(JavaScript must be enabled to view this email address). A paper copy should not be sent to EPA.

The fee for 2023 is $3,400 for each registration up to the maximum fees that can be assessed to a single registrant. Each registrant of a pesticide must pay the annual fee and e-mail the response to EPA by Tuesday, January 17, 2023. Registrations for which the fee is not paid will be canceled, by order and without a hearing. As in years past, payment must be made electronically online at www.pay.gov.

For certain qualified small businesses, the first product registration maintenance fee may be reduced by 25 percent, if the applicant meets the following criteria:

1. The applicant has 500 or fewer employees globally;
2. During the three-year period prior to the most recent maintenance fee billing cycle, the applicant has average annual gross revenue from all sources that does not exceed $10 million; and
3. The applicant holds a total of five or fewer registrations subject to the maintenance fee.

There also are maintenance fee waivers for products that meet the criteria in two specific categories: minor agricultural use products and public health pesticides. The procedure for requesting a fee waiver for individual products is described in the instructions provided by EPA.

More information on the annual maintenance fees is available on EPA’s website.

By Lisa R. Burchi, James V. Aidala, and Dennis R. Deziel

On November 29, 2022, the U.S. Environmental Protection Agency (EPA) announced proposed new mitigation measures for 11 rodenticides, including measures to reduce potential exposures to three federally listed endangered and threatened species and one critical habitat. The mitigation measures are part of EPA’s goals outlined in its April 2022 Endangered Species Act (ESA) Workplan and one of the ESA pilots described in its November 2022 update.

Comments on the proposed interim decisions (PIDs) are due on or before February 13, 2023, in the following pesticide registration review dockets:

• Brodifacoum, EPA-HQ-OPP-2015-0767;
• Bromadiolone, EPA-HQ-OPP-2015-0768;
• Bromethalin, EPA-HQ-OPP-2016-0077;
• Chlorophacinone, EPA-HQ-OPP-2015-0778;
• Cholecalciferol, EPA-HQ-OPP-2016-0139;
• Difenacoum, EPA-HQ-OPP-2015-0769;
• Difethialone, EPA-HQ-OPP-2015-0770;
• Diphacinone (and its sodium salt), EPA-HQ-OPP-2015-0777;
• Strychnine, EPA-HQ-OPP-2015-0754;
• Warfarin (and its sodium salt), EPA-HQ-OPP-2015-0481; and
• Zinc Phosphide, EPA-HQ-OPP-2016-0140.

As background, in 2008, EPA issued a risk mitigation decision (RMD) for 10 rodenticides that set forth mitigation measures to reduce risks to human health and non-target organisms, including implementing minimum packaging size requirements for products on the consumer market (must be in packages one pound or less), prohibiting products intended for general consumers (i.e., homeowners or residential consumers) from containing second-generation anticoagulant rodenticides (SGAR), and requiring tamper- and weather-resistant bait stations for outdoor, above-ground placements where children, pets, and wildlife may be present. The 2009 RMD represented EPA’s final decision on the reregistration eligibility of rodenticide products at that time and constituted EPA’s final action.

The PIDs cover three first-generation anticoagulant rodenticides (FGAR), four SGARs, and four non-anticoagulant rodenticides. Strychnine (the 11th rodenticide) was not part of the 2008 RMD but is now included as part of EPA’s registration review of the rodenticide group.

The PIDs propose additional mitigation measures based on findings in the 2020 draft human health and ecological risk assessments (DRA) and comments submitted on the DRA. According to EPA, these measures are intended to reduce exposure to non-target organisms. Proposed measures include requiring bait to be placed in tamper-resistant bait boxes to ensure it is contained and requiring users to collect carcasses of rodents that may have consumed rodenticides to prevent further exposures to non-target organisms that could consume the carcasses. In addition, in its PIDs EPA proposes that all products, excluding those registered solely for use by homeowners, include label language directing users to access the web-based Bulletins Live! Two and follow the measures contained in any Endangered Species Protection Bulletin(s) for the area in which the user is applying the product.

EPA states the ESA workplan describes how it is developing early mitigation for a subset of species where EPA predicts a likelihood of a jeopardy or adverse modification finding for one or more of the registration review pilot pesticides if mitigation is not undertaken. One of these pilots is for rodenticides, which will focus on addressing effects to mammals and birds that consume rodenticide bait (primary consumers) and to birds, mammals, and reptiles that consume primary consumers (secondary consumers).

According to EPA, as part of its registration review ESA pilot for the rodenticides, EPA evaluated their potential effects on individuals and populations of Stephens’ kangaroo rat, Attwater’s prairie chicken, and the California condor and its designated critical habitat. EPA states it chose these three listed species because they represent species that may be affected by rodenticides through different routes of exposure (e.g., primary consumption by Stephens’ kangaroo rat and Attwater’s prairie chicken, secondary consumption by California condor). EPA’s draft evaluation determined that rodenticide use is “likely to adversely affect” these three species but predicted the proposed mitigations will protect them from likely “jeopardy” (i.e., potential impacts to the survival of listed species) and “adverse modification” of critical habitat. A “likely to adversely affect” determination means EPA reasonably expects that at least one individual animal of any of the three species may be exposed to one or more of the rodenticides at a sufficient level to have an adverse effect. While EPA has made predictions about the likelihood of jeopardy and adverse modification, the U.S. Fish and Wildlife Service (USFWS) is responsible for making the actual jeopardy/adverse modification findings for these species and has the sole authority to do so.

To focus the mitigations where they are most needed while retaining options for rodenticide users, EPA states the proposed mitigation measures for the three listed species would be targeted in specific geographic areas most relevant to the species. The PIDs include proposed mitigation measures to be included on the Bulletins Live! Two website for the species and the critical habitat of the California Condor. The draft evaluation for the three species and one critical habitat and associated mitigation measures are pilots for other listed species that may be similarly exposed and affected by rodenticides. In developing and applying mitigation measures for these species, EPA stated that it recognized that not all rodenticides have the same effects.

In addition to describing the pilot and the mitigation measures for the selected species, the PIDs also describe EPA’s plans for expanding those mitigation measures to the other approximately 90 listed species potentially affected by rodenticides. When this plan is issued in final, it will be known as the Rodenticide Strategy that EPA described in its November 2022 update to its ESA Workplan.

EPA also announced it intends to make effects determinations for all listed species available in a draft biological evaluation (BE), which EPA anticipates making available for public comment in November 2023. The BEs will contain EPA’s draft analysis of the potential effects of the rodenticides on listed species and their designated critical habitats and will identify mitigation measures for these species and critical habitats to avoid or minimize exposure from the rodenticides. EPA expects to complete the final BE for the rodenticides in November 2024.

If EPA’s final BE continues to find that rodenticide use is likely to affect adversely listed species or adversely modify their critical habitats, then EPA will initiate formal consultation and share its findings with the USFWS, which in turn can use the information in EPA’s BE to inform its biological opinions. If the USFWS determines in its final biological opinions that additional mitigations are necessary to address any jeopardy or adverse modification determination, or to address any incidental take, then EPA will work to ensure that any necessary registration or labeling changes are made.

Additional information on EPA’s rodent control pesticide safety review is available here.

Commentary

The proposed interim decisions cover the full “rodenticide cluster” -- seven anticoagulant rodenticides and four non-anticoagulant rodenticides. Strychnine (the 11th rodenticide) was not part of the 2008 Risk Management Decision but is now included as part of EPA’s registration review of the rodenticide group.

EPA has determined that rodenticide use is “likely to adversely affect” three representative species but also predicts that the proposed mitigations will protect them from likely “jeopardy.” Note that while EPA has made predictions about the likelihood of jeopardy and adverse modification, the USFWS is responsible for making the actual jeopardy/adverse modification findings for these species and has the sole authority to do so. As stated above, EPA intends to make effects determinations for all listed species (about 90 species) available in a draft BE in November 2023, and EPA expects to complete the final BE for the rodenticides in November 2024. In short, this November 2022 action represents a mid-point, not a starting point or endpoint, for action on rodenticides, and EPA’s approach on addressing endangered species will be a good indicator of how well the ESA Workplan process and approach are working over the coming months.

Requiring bait to be placed in tamper-resistant bait boxes to ensure it is contained is a common, straightforward measure and generally follows current practices. Requiring users to collect carcasses of rodents that may have consumed rodenticides can be difficult to measure compliance and to enforce and also raises different public health concerns; we expect this approach to be debated further. In addition, the proposed interim decisions would require that all products -- excluding those registered solely for use by homeowners -- include label language directing users to access the web-based Bulletins Live! Two and follow the measures contained in any Endangered Species Protection Bulletin(s) for the area in which the user is applying the product. Understanding this process and the map for the user’s region specifically will be a process that applicators adjust to over time, but the quality and clarity of EPA’s assessments and maps will be important and need improvements. The Bulletins Live! Two system will need continuous investment and improvements to be effective, and linking all of these interactive processes (e.g., rodenticide strategy, ESA Workplan, web-based mapping and announcement systems) could prove cumbersome over time if not managed closely.

Overall, this continues the pesticide program’s march through the thicket of ESA decisions that must be made over the next many years. EPA is using its revised approach as outlined in earlier announcements regarding how it will attempt to comply with ESA as part of the registration and registration review process. The positive news is that EPA is starting to make progress on ESA compliance, which has long been discussed as part of program planning and in response to numerous ESA lawsuits over the past many years. Less clear is how EPA’s requirements will be able to be implemented and/or enforced, and how attempts to implement or comply with label changes might result in controversies among applicators and users of the affected pesticide products. The feasibility and acceptability of some label requirements are among the open questions about EPA’s new approaches to address this long-standing issue.

By Lisa R. Burchi, James V. Aidala, and Barbara A. Christianson

On November 15, 2022, the California Department of Pesticide Regulation (DPR) made two announcements: an enforcement action relating to 1,3-Dichloropropene (1,3-D) and chloropicrin and an announcement on a proposed rule on additional use restrictions on 1,3-D. These actions may have significant impacts on registrants and growers who use soil fumigants.

Enforcement Action

DPR issued a licensing action against TriCal, a company that performs field fumigations, primarily using chloropicrin and 1,3-D. DPR found that TriCal had numerous violations that resulted in serious illness and injury and dozens of other violations. During a licensing action, DPR can seek civil penalties or seek to revoke or suspend the license of a company that is licensed to do pest control work, sell pesticides, or advise on pest control in California.

DPR states that TriCal has been subject to past enforcement actions dating back to 2014. These past violations include a combined 40 incidents -- four of which were “priority episodes” (i.e., incidents involving serious illness or injury, or an episode involving five or more people). Specifically, TriCal paid over $125,000 in administrative civil penalties to County Agricultural Commissioners and a $44,275 fine to the U.S. Environmental Protection Agency (EPA).

DPR’s press release states that nine episodes were cited in the most recent licensing action, including the following:

• In October 2020, DPR alleged 20 residential bystanders and three members of the Salinas Fire Department experienced symptoms of pesticide exposure from a TriCal misapplication.
• In October 2019, DPR alleged 39 fieldworkers were exposed to 1,3-D and chloropicrin due to TriCal’s misapplication. Thirty-two fieldworkers experienced symptoms of pesticide exposure, and three people sought medical care for their symptoms.
• In October 2018, DPR alleged TriCal misapplied a product containing 1,3-D and chloropicrin and, as a result, 13 residential bystanders experienced symptoms of pesticide exposure.

This licensing action comes as DPR announces proposed regulatory requirements to strengthen use restrictions on 1,3-D to protect public health. In its proposed regulation, DPR 22-005 Health Risk Mitigation and Volatile Organic Compound Emission Reduction for 1,3-Dichloropropene, DPR states its “broad objectives of the proposed regulations are to mitigate the potential 72-hour acute risk and 70-year lifetime cancer risk to non-occupational bystanders from the use of 1,3-D, and to reduce [volatile organic compound] VOC emissions from 1, 3-D field soil fumigations.” This proposal is based in part on a health-protective regulatory target established last year after consultation with state and local agencies. Specifically, the proposed action, if issued in final, would:

1. Allow the use of 1,3-D only for the production of agricultural commodities, effectively prohibiting other uses that are not currently registered;
2. Establish mandatory setbacks (distances from occupied structures where 1,3-D cannot be applied);
3. Set limits on the application rate and acres treated for individual field soil fumigations;
4. Place restrictions on multiple field soil fumigations that do not meet distance or time separation criteria;
5. Limit the allowed methods to apply 1,3-D, including establishing criteria for acceptable types of tarpaulins that can be used;
6. Require an annual report from DPR that includes evaluations of 1,3-D use and air monitoring results; and
7. Require the inclusion of certain information in existing pesticide use records and pesticide use reports.

Comments are due on or before January 18, 2023. DPR will accept written comments that are submitted via U.S. mail and postmarked no later than January 18, 2023. Comments also may be transmitted via e-mail to .(JavaScript must be enabled to view this email address) or by facsimile at 916-324-1491 and must be received no later than 5:00 p.m. (PST) on January 18, 2023.

DPR will conduct a public hearing to accept comments on these amendments. The public hearing is scheduled for January 18, 2023, starting at 9:30 a.m. (PST). The hearing will be in a hybrid format with both a physical location and an option to participate remotely:

Physical Location:

CalEPA Headquarters Building

Byron Sher Auditorium

1001 I Street, 2nd Floor

Sacramento, CA 95814

Remote Location:

Zoom

Webinar ID: 826 1358 3257

Password: 045724

Direct link to join the meeting from a web browser or Zoom client:

https://us02web.zoom.us/j/82613583257?pwd=UGJ0WkxtbFlFYUdrQmJYb3V3QyszUT09

One tap to join from a mobile phone: +16699009128,,82613583257#,,,,*045724#

Or call from a landline: +1-669-900-9128 and enter the Webinar ID and Password (above) when prompted

The hearing also will be accessible via public webcast for persons who would like to watch this hearing without participating. The public webcast can be accessed by visiting the following web address: https://video.calepa.ca.gov/#/

Commentary

These actions add many new restrictions on the use of these pesticides. Growers who rely on these products will have to comply with the new restrictions and hope that they address the state’s concerns or face additional restrictions or even a decision by DPR to not register the pesticides regardless of what EPA’s federal label allows. The state actions may in turn raise new issues for EPA. DPR’s justification for greater controls mentions the possible impact on local communities, which may cause greater focus on environmental justice matters, and the evolution of this issue should be monitored.

By James V. Aidala, Dennis R. Deziel and Heather F. Collins, M.S.

On November 16, 2022, the U.S. Environmental Protection Agency (EPA) announced it released an Endangered Species Act (ESA) Workplan Update (Workplan Update) that outlines major steps to increase protections for wildlife and regulatory certainty for pesticide users. The Workplan Update details how EPA will pursue protections for nontarget species, including federally listed endangered and threatened (i.e., listed) species, earlier in the process for pesticide registration review and other Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) actions. According to EPA, these early protections will help EPA comply with the ESA, thus reducing its legal vulnerability, providing farmers with more predictable access to pesticides, and simplifying the ESA-FIFRA process that, left unchanged, creates both significant litigation risk and a workload far exceeding what EPA has the resources to handle.

EPA states this update is a follow-up to EPA’s April 2022 ESA Workplan that addresses the complexity of meeting its ESA obligations for thousands of FIFRA actions annually. The ESA Workplan prioritizes certain FIFRA actions for ESA compliance, outlines how EPA will pursue early mitigation for listed species under FIFRA, and describes directions for expediting and simplifying the current pesticide consultation process.

As part of registering new pesticides or reevaluating pesticides during registration review, EPA has a responsibility under the ESA to ensure certain pesticide registrations do not jeopardize the continued existence of listed species or adversely modify their designated critical habitats. EPA states that it has seen in the past few decades an increase in litigation due to EPA’s failure to meet its ESA obligations when taking FIFRA actions. Over the next six years, existing court-enforceable deadlines will require EPA to complete ESA reviews for 18 pesticides -- the most EPA estimates it can handle during this period based on its current capacity and processes. Ongoing litigation and settlement discussions for other lawsuits cover dozens of additional pesticides and will likely fill the EPA’s ESA workload well beyond 2030. According to EPA, if its ESA efforts continue at this pace, a future court may decide to curtail drastically pesticide use until EPA meets its obligations. EPA believes this situation would be unsustainable and legally tenuous and provide inadequate protection for listed species and create regulatory uncertainty for farmers and other pesticide users.

The Workplan Update is EPA’s first update to the ESA Workplan and covers four main goals:

1. Describes EPA’s overall approach to mitigating ecological risks in registration review, which includes prioritization of registration review cases based on opportunities to reduce a pesticide’s risk to human health or the environment.
2. Proposes a menu of FIFRA Interim Ecological Mitigation measures that EPA will draw from for many future conventional and biological pesticide registration and registration review actions to protect nontarget species. For each FIFRA action, EPA will consider this menu and propose, based on the risks and benefits of the particular pesticide, which specific measures to include on the pesticide label.
3. Proposes label language to expand the use of online endangered species protection bulletins to implement geographically specific mitigation measures for individual listed species. These measures are designed to focus protections only in specific needed areas, thus minimizing impacts to agriculture. Where needed, EPA may develop these measures to complement the generic FIFRA ecological mitigation described above.
4. Describes current and future programmatic initiatives with other federal agencies to prioritize mitigation for listed species that are particularly vulnerable to pesticides and to improve the efficiency and timeliness of the ESA-FIFRA process.

The first strategy described in EPA’s ESA Workplan is to “meet ESA obligations for FIFRA actions.” EPA states as part of its work to execute this strategy, it has identified a menu of Interim Ecological Mitigation measures it will use as a starting point to address pesticide risks to nontarget species during registration and registration review.

The menu of Interim Ecological Mitigation will include measures to reduce pesticide spray drift and pesticide runoff and will be considered as part of EPA’s upcoming proposed interim registration review decisions. While EPA intends for this set of Interim Ecological Mitigation measures to apply widely to many pesticides, EPA will consider the menu of options for any given pesticide depending on the level of risk that it poses to species and the exposure route.

EPA anticipates that this approach will more efficiently establish protections for nontarget species, including listed species, and standardize the protections across similar pesticides, in contrast to identifying mitigation measures pesticide by pesticide or species by species, as EPA has typically done in the past.

EPA states it will also work with registrants to add language on pesticide incident reporting, advisory language to protect insect pollinators, and language to most outdoor-use pesticide labels that directs users to reference Bulletins Live! Two, a website where pesticide users can find endangered species protection bulletins. These bulletins describe geographically specific use limitations to protect threatened and endangered species and their designated critical habitat.

EPA expects that once consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service is completed for any given outdoor-use pesticide, endangered species protection bulletins may be necessary for at least one listed species.

EPA also expects that working with registrants proactively to add the reference to Bulletins Live! Two to pesticide labels in advance of consultation will ultimately save EPA, state partners, and registrants time and resources by minimizing the number of amendments to labels.

The ESA Workplan Update also describes initiatives that, according to EPA, will help it and other federal agencies improve approaches to mitigation under the ESA and improve the interagency consultation process outlined in the ESA Workplan. These initiatives include EPA’s work to identify ESA mitigation measures for pilot species, incorporate early ESA mitigation measures for groups of pesticides (e.g., herbicides), and develop region-specific ESA mitigations.

Comments on the proposed set of interim mitigation measures and the proposed revisions to label language included in the Workplan Update appendix are due on or before January 30, 2023. Comments can be submitted at EPA-HQ-OPP-2022-0908.

Commentary

This next phase of the ESA Workplan provides more detail about how EPA plans to impose various mitigation measures to meet its ESA obligations when registering a pesticide. The most favorable view of what EPA has presented is that it continues the march toward ESA compliance, which is long overdue, and provides more detail about the kinds of mitigation approaches it will place on pesticide labels to meet ESA requirements. The less favorable view here is that EPA has outlined a number of “off the shelf” mitigation options (buffers to reduce pesticide drift and water runoff), and EPA might impose such conditions in many instances where more careful analysis of usage data and site- or use-specific considerations might lessen the areas where such mitigation measures are needed.

EPA has stated previously as part of its earlier Workplan document, issued in April 2022, that using the present approaches EPA would complete only 5 percent of the ESA required reviews in about 18 years -- implying that the current approach would take about 360 years to complete. This next iteration of the Workplan, describing “early mitigation” strategies, is designed to reduce this unacceptable timeframe (360 years), but is likely to lead to fears among some stakeholders that in a “rush” to complete this work, EPA will make overly conservative label restrictions and reduce availability of the pesticide without increased species protections. Such concerns raise immediate ancillary concerns about stakeholder involvement in decision-making, compliance with what might be complicated label requirements, and enforcement of what is already typically a long list of label requirements for many current products. An example of such issues: one mitigation option example discussed is “do not use when rain is expected in the next 48 hours” -- which could raise issues concerning what or how compliance might be proven or enforced.

Again, to be sure, this next document about how EPA plans to make significant progress in meeting its ESA obligations continues the effort to convince courts that it is meeting its ESA obligations. As such, it represents a large step forward where in the past EPA was left with little progress or plans to present in court as part of litigation over ESA compliance. As it continues to reveal its plans and options, however, stakeholders will need to follow closely and consider the possible impacts of the Workplan and the resulting label proposals to follow.

By Lisa R. Burchi, James V. Aidala, and Dana S. Lateulere

On November 8, 2022, the U.S. Environmental Protection Agency (EPA) issued a final rule adding chitosan (Poly-D-Glucosamine), a naturally occurring substance found in the cell walls of all crustaceans, many fungi, and the exoskeletons of most insects, to its minimum risk pesticide exemption list. 87 Fed. Reg. 67364. EPA states that the listing also includes those chitosan salts that can be formed when chitosan is mixed with the acids that are listed as active or inert ingredients eligible for use in minimum risk pesticide products.

According to EPA’s announcement of the final rule, the purpose of the exemption list is to eliminate the need for EPA to expend significant resources to regulate products deemed to be of minimum risk to human health and the environment. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b) minimum risk exemption, products that contain only those active and inert ingredients allowed by the exemption and that meet certain requirements are exempt from the normal FIFRA registration requirements. Approximately a decade has passed since a substance was added to the list of ingredients eligible for the minimum risk pesticide exemption.

Chitosan is currently registered with EPA under FIFRA as a fungicide, antimicrobial agent, and plant growth regulator that boosts the ability of plants to defend against fungal infections. EPA’s decision was based on a review of an October 10, 2018, petition requesting that chitosan be added to the list of active ingredients allowed in exempted minimum risk pesticide products. In November 2020, EPA requested public comment on the proposed rule to add chitosan to the list of active ingredients eligible for the exemption. Additionally, in November 2021, EPA requested information from the petitioner on chitosan salts and their potential effect on the environment.

EPA states that after reviewing the latest available science and comments on the proposed rule and the Notice of Data Availability, it has determined to add chitosan to its list of active ingredients eligible for EPA’s minimum risk pesticide exemption. EPA’s analysis of the available data suggests that chitosan and chitosan salts are of low toxicity to humans and that no environmental risks of concern have been identified. As a result of this final rule, products that contain chitosan and that comply with all the other requirements applicable to minimum risk pesticides will no longer need to be registered under FIFRA. Products containing chitosan that cannot meet all minimum risk pesticide requirements may still require registration.

The final rule is available here. Additional information on chitosan is available on our blog.

Commentary

As the first change to the list in many years, this may represent EPA’s attempt to communicate further about “safer” or reduced risk products to the public. These Section 25(b) products are allowed to make pesticidal claims without EPA review and approval and can make certain claims that are not permitted for registered pesticides (e.g., “safe for use around children and pets,” “all natural”). Based on EPA’s determination, these products will not be subject to EPA review, thus reducing workload for which program resources may be used on other products that possibly pose greater risks.

At the same time, this current effort to issue regulation changes to communicate better information to the public does not address past commitments to clarify important safety information about possibly misleading or often misunderstood claims for products already exempted from registration requirements under Section 25(b). Specifically, in response to a 2006 petition (see Petition of the Consumer Specialty Products Association to Modify EPA’s Exemption from FIFRA Regulation for Minimum Risk Pesticides under 40 C.F.R. § 152.25(f) (Mar. 15, 2006)) about health and safety claims for Section 25(b) products making implied public health label claims, EPA agreed to issue regulations to make requirements for insect repellents more clear for Section 25(b) products and to ensure that insect repellent products are safe and effective.

Regarding insect repellents, the 2006 petition argued that the average consumer would not distinguish between labeling claims to “repel mosquitoes,” which are allowed for minimum risk pesticides, and labels that make public health claims by linking a mosquito with a specific disease (e.g., “repel mosquitoes which may cause West Nile Virus”), which are not allowed for minimum risk pesticides.

In response to the 2006 petition, EPA pledged to ensure that insect repellents actually repelled insects. To date, little progress has been made, and no change to the Section 25(b) situation regarding repellents has been proposed or made final. The commitment to clarify and ensure effectiveness of insect repellents has not been addressed and does not appear to be on any announced regulatory agenda for the pesticide program.

By Lisa R. Burchi and Barbara A. Christianson

On November 3, 2022, the California Department of Pesticide Regulation (DPR) announced it reached a settlement agreement with Amazon.com Services, LLC (Amazon) regarding the illegal sale of pesticides in California. According to DPR, its review of Amazon uncovered multiple violations. Among them, it sold unregistered pesticides in California, failed to report and pay required mill assessment fees associated with the sale of registered pesticides in California, and failed to hold a valid pesticide broker’s license.

Under the terms of the agreement, Amazon will pay DPR a total of $4.97 million -- $3.69 million in unpaid pesticide sales assessment fees and related late penalties, and $1.28 million in civil penalties associated with retail sales of unregistered pesticides into California. DPR states that Amazon also agreed to register as a pesticide broker and report and pay the mill assessment fees associated with all future retail sales of registered pesticides into California.

Under California law, pesticides that are registered by EPA also must be registered by the state before they are used, possessed, or offered for sale in California. Based on DPR’s evaluation of a product’s potential human health and environmental risks and efficacy, DPR may impose state-specific requirements, including additional data requirements or label use restrictions.

California also has its own state requirements for mill assessments, which is a fee to be paid for sales of pesticides that are registered with DPR and sold into California. Specifically, a mill assessment is charged at the first point of sale of a pesticide in California. Generally, the registrant is responsible for reporting sales and paying the mill assessment when it has knowledge, at the time of sales, that the pesticide is being sold in California. If the registrant does not have knowledge at the time of sale, the party that is the first to sell the pesticide in California is responsible for reporting and paying the mill assessment. If a party other than the registrant is the first to sell a pesticide into or within California, this first seller party must obtain either a pesticide broker or a pest control dealer license (whichever is appropriate) from DPR.

Additional information on DPR’s programs is available here.

By Dana S. Lateulere and Barbara A. Christianson

On October 19, 2022, the U.S. Environmental Protection Agency (EPA) announced that it activated its emerging viral pathogen (EVP) guidance in support of the Centers for Disease Control and Prevention’s (CDC) response to the Ebola virus cases in western Uganda. With EPA’s EVP guidance, additional disinfectants, for which EVP claims have been approved, can be used against the Ebola virus.

According to EPA’s press release, EPA developed its EVP guidance to aid in the availability of EPA-registered disinfectants for use against EVPs. EPA states that it divides viruses into three tiers based on how difficult they are to kill. The Ebola virus falls into Tier 1, the category of viruses that are easiest to kill. EPA expects disinfectants qualified for use against any EVPs in Tiers 1, 2, and 3 to be effective against the Ebola virus when used according to the label use directions.  To find these products, EPA recommends searching its list of disinfectants and filter for products for use on Tier 1 viruses.

EPA states the use of products with EVP claims supplements but does not replace other infection control practices. Individuals should follow CDC, state, and local public health guidelines.

According to EPA, EPA’s website “provides the list of products registered for use against Ebola, and list of disinfectants for emerging viral pathogens.”

Additional information on EVP guidance is available on our blog.