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By Lisa R. Burchi, James V. Aidala, and Heather F. Collins, M.S. On May 31, 2023, the U.S. Environmental Protection Agency (EPA) released a final rule exempting a class of plant-incorporated protectants (PIP) created using genetic engineering, from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. According to EPA’s May 25, 2023, press release, this rule will reduce costs for the regulated community and result in increased research and development activities, consistent with Executive Order 14081 on advancing biotechnology. EPA states that the rule also may result in the commercialization of new pest control options and reduced use of conventional pesticides. The final rule will be effective on July 31, 2023. EPA states the final rule will allow PIPs to be exempt from FIFRA registration and FFDCA tolerance requirements in cases where they both pose no greater risk than PIPs that EPA has already concluded meet safety requirements, and when they could have otherwise been created through conventional breeding. The final rule reflects the biotechnological advances made since 2001, when EPA first exempted PIPs derived through conventional breeding from FIFRA registration and FFDCA tolerance requirements but did not at that time exempt PIPs created through biotechnology. In the rule, EPA provides criteria and definitions that identify two categories of PIPs that are exempted through this action from FIFRA registration and FFDCA tolerance requirements:
For the first exempted category, EPA will require a notification process for EPA to confirm that the PIP is eligible for the exemption. For the second exempted category (loss-of-function PIPs), developers of PIPs can submit to EPA a self-determination letter that the exemption applies. EPA also is establishing recordkeeping requirements for these exempted PIPs, clarifying general qualifications for exemption at 40 C.F.R. Section 174.21; clarifying the relationship between the existing exemptions for PIPs from sexually compatible plants (40 C.F.R. Section 174.25) and the newly issued exemption for “PIPs created through genetic engineering from a sexually compatible plant” (40 C.F.R. Section 174.26); and allowing the existing inert ingredient exemption at 40 C.F.R. Section 174.705 to include genetic engineering. EPA notes that in the future, as biotechnology advances further, it intends to consider exempting additional categories of PIPs from both FIFRA registration and FFDCA tolerance requirements as well as adding categories of exempted PIPs to the list of categories that do not require EPA confirmation of eligibility. Additional information, including the response to comment document, is available in docket EPA-HQ-OPP-2019-0508. Commentary This final rule is the next step for EPA’s Office of Pesticide Programs (OPP) on the path of EPA’s regulation of biotechnology pesticide products. It sets forth how OPP will handle products created by “Clustered Regularly Interspaced Short Palindromic Repeats” (CRISPR). In more general terms, CRISPR refers to manipulating plant genes with a method that was not available at the time the first biotechnology regulations were developed by EPA in the mid-1990s. This is why EPA needs to “update” its regulations, which is the purpose of the final rule. Proponents of biotechnology methods argue that CRISPR allows the genes of plants to be manipulated more precisely and can be used to “simply” drop out a gene or add one from the same -- sexually compatible -- genome of the target plant. It follows that this is much like “traditional plant breeding” only done more precisely and more rapidly. Critics will likely raise questions about whether any product using this method, and not using traditional methods, might have some kind of unexpected result or unintended eventual effect. One can expect some adverse comments regarding these products even though EPA (among many others) lays out a rationale that this is an extension of its current regulations exempting products of traditional plant breeding from regulation under FIFRA/FFDCA (and not exempting such products from other regulatory authorities). There also were concerns raised in comments submitted in response to the October 9, 2020, proposed rule. In particular, some in industry remain concerned that the final rule creates differential treatment for products due solely to the methods of development (i.e., biotechnology vs. conventional), thus subjecting products created using biotechnology to additional regulatory and recordkeeping requirements, even in cases when those products could have been created using older research and development approaches. EPA’s basic requirements for biotechnology products that regulate inter-species gene manipulation would not change. Also worth noting is that the rule also would allow a developer to submit the product for EPA review to affirm that it qualifies for the exemption (i.e., a M009 Pesticide Registration Improvement Act (PRIA) action, which can lead to EPA delays in processing). The EPA docket includes a slide deck with a helpful summary of the final rule and its rationale.
By Lisa R. Burchi and Heather F. Collins, M.S. On May 23, 2023, U.S. Environmental Protection Agency (EPA) Region 9 announced a settlement with Watts Regulator Company for alleged violations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) related to the sale or distribution of misbranded water filtration devices and importation of pesticides into the United States. Watts, which is headquartered in Massachusetts, imported devices through a port of entry within EPA Region 9. The specific alleged violations relate to sales and distribution of various water filtration products that EPA concluded are misbranded devices. EPA’s misbranding violations included false and misleading claims on the labeling that the water filtration products reduce water impurities; reduce parasitic cysts; kill microorganisms such as bacteria, viruses, and mold; and sterilize. EPA states that “The sale of misbranded products that claim to sterilize or kill microorganisms is both unlawful and a clear risk to human health.” EPA asserts that Watts also failed to display EPA establishment numbers clearly and prominently on its labels and did not file all necessary importation requirements. Under FIFRA, EPA establishment numbers must appear on the labels of pesticide devices, and the importer of such devices must submit a Notice of Arrival of Pesticides and Devices form before the arrival of the shipment in the United States. Watts has agreed to pay a civil penalty of $60,558 under the settlement to resolve these violations. Commentary Under FIFRA and its implementing regulations, devices are exempt from pesticide registration requirements but are subject to certain other FIFRA requirements. EPA published in February 2023 a compliance advisory for devices. EPA states that the purpose of the advisory is to provide critical information to the regulated community about producing, distributing, or selling pesticide devices. This case serves as another reminder to producers, importers, suppliers, and distributors to review their devices and the FIFRA requirements for devices that are found at 40 C.F.R. Section 152.500 and related guidance. EPA enforcement for issues related to pesticide devices has been robust, and failure to identify a product as a device and to comply with all requirements related to devices (e.g., establishment, recordkeeping, imports, exports, child-resistant packaging, labeling, false or misleading claims) may result in a range of EPA actions, including delaying import of the device; a Stop Sale, Use, or Removal Order (SSURO); device seizure; and/or civil and/or criminal penalties.
By Heather F. Collins, M.S. and Barbara A. Christianson On May 17, 2023, the U.S. Environmental Protection Agency (EPA) announced it released, and is seeking public comment on, draft guidance that claims to improve the efficiency of EPA’s Endangered Species Act (ESA) analyses for new pesticide active ingredient applications and active ingredients undergoing registration review. When the guidance is issued in final, EPA states that it will fulfill the requirements outlined in the Pesticide Registration Improvement Act of 2022 (PRIA 5) and extends the goals outlined in EPA’s 2022 ESA Workplan to protect listed species from exposure to pesticides. EPA will accept public comments on the draft guidance document for 30 days in docket EPA-HQ-OPP-2023-0281. Comments are due on or before June 16, 2023. One of the requirements under PRIA 5 is that EPA develop, receive comments with respect to, and finalize guidance to registrants regarding analyses necessary to support the evaluation of potential adverse effects from outdoor uses of conventional pesticides and biopesticide products on listed species and designated critical habitat. EPA states that “The information in this guidance reflects lessons EPA has learned over the past several years as it continues to make progress towards meeting its ESA obligations.” PRIA 5 specifies that the draft guidance must be available for public comment and must be issued in final within nine months of PRIA 5 issuance. The draft guidance applies to:
According to EPA, the guidance document does not create new requirements for applicants, but will help applicants, through recommendations outlined in the document, address potential effects to listed species for new active ingredients and registration review actions. In particular, the recommendations focus on actions that applicants can pursue voluntarily to inform their proposed mitigation measures for listed species. These actions include identifying where a pesticide will be used, how species may be exposed to the pesticide, and how to select mitigation to reduce the exposure. If followed, these recommendations should expedite the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) action and improve the efficiency of the overall ESA-FIFRA process. EPA states that the guidance document for new uses of existing active ingredients will be made available at a later date.
By Lynn L. Bergeson and Carla N. Hutton The U.S. Department of Agriculture (USDA) announced on April 11, 2023, that its Agricultural Research Service (ARS) recently developed sustainable, machine-washable antimicrobial wipes that can be used at least 30 times for cleaning hard and nonporous surfaces. According to USDA, ARS researchers developed the antimicrobial wipes “by using raw cotton fiber that naturally produced silver nanoparticles inside the fiber in the presence of a silver precursor.” USDA states that the embedded silver nanoparticles then release silver ions that act as antibacterial agents and kill harmful bacteria. USDA notes that in their research, scientists found that the wipes killed 99.9 percent of harmful bacteria S. aureus and P. aeruginosa on surfaces. USDA states that the advantages to this technology include omitting the conventional pretreatments of raw cotton fibers (such as scouring and bleaching), which consume a large number of chemicals and energy, and not requiring any chemical agents except for a silver precursor. According to USDA, the technology “also transforms cotton fibers themselves into antimicrobial agents rather than serving as a carrier of antimicrobial agents, which is what makes them reusable.” USDA notes that the antimicrobial wipes are made from “natural cotton fibers, rather than conventional petroleum-based synthetic fibers.” The wipes can be reused by being washed in the laundry. More information on the antimicrobial wipes is available in an article in Molecules entitled “Washable Antimicrobial Wipes Fabricated from a Blend of Nanocomposite Raw Cotton Fiber.”
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:
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:
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:
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:
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:
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.
Bergeson & Campbell, P.C.’s (B&C®) January 31, 2023, webinar “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2023” is now available for on-demand viewing. During this one-hour webinar, Lynn L. Bergeson, Managing Partner, B&C; James V. Aidala, Senior Government Affairs Consultant, B&C; Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Dennis R. Deziel, Senior Government Affairs Advisor, B&C discussed the U.S. Environmental Protection Agency’s (EPA) priorities, leadership, and operating environment in the new year. This includes a review of priorities and challenges that will shape updates that are expected to affect Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) implementation in 2023.
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). This webinar offers our best-informed judgment as to the trends and key developments chemical industry stakeholders can expect in 2023. At a political level, the Republicans’ narrow control of the U.S. House of Representatives will almost certainly invite a greater degree of oversight of U.S. Environmental Protection Agency (EPA) actions, particularly with respect to implementation of the 2016 amendments of the Toxic Substances Control Act (TSCA). Concepts core to the Act, including “reasonably foreseen,” “to the extent necessary,” “systematic review,” and “best available science,” continue to evolve and not always in predictable, coherent, and consistent ways. Similar policy shifts are seen in the agricultural and biocidal area, with perhaps less dramatic effect. How the 2024 general election will influence EPA’s policy choices is unclear. In that the election cycle has already begun, we caution all to buckle up and prepare for what we expect will be an eventful, fascinating year.
Register now to join Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®); James V. Aidala, Senior Government Affairs Consultant, B&C; Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Dennis R. Deziel, Senior Government Affairs Advisor, B&C for this informative and forward-looking webinar. Topics Covered:
Speakers Include:
James V. Aidala, Senior Government Affairs Consultant with B&C, has been intimately involved with the TSCA and FIFRA legislative reauthorization and key regulatory matters for over four decades. Mr. Aidala brings extensive legislative experience on Capitol Hill and past experience as the senior official at EPA for pesticide and chemical regulation and provides clients with vital insights into not only relevant current policies of EPA and sister agencies, but also the way these policies have been or are likely to be formulated to help clients more successfully address regulatory matters. Richard E. Engler, Ph.D. is Director of Chemistry with B&C. Dr. Engler is a 17-year veteran of EPA and is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA’s Office of Pollution Prevention and Toxics (OPPT) and leader of EPA’s Green Chemistry Program. He has participated in thousands of TSCA substance reviews at EPA, as well as pre-notice and post-review meetings with submitters to resolve complex or difficult cases, and he draws upon this invaluable experience to assist B&C clients as they develop and commercialize novel chemistries. Dennis R. Deziel, Senior Government Affairs Advisor with B&C, has an extraordinary depth of experience and knowledge of the regulatory process and government advocacy, honed through a career of senior leadership roles at EPA and the U.S. Department of Energy (DOE), among other significant positions. As Administrator of EPA Region 1, Mr. Deziel led the region’s 500-plus employees in managing energy, environment, and sustainability policy and programs, building coalitions across a wide range of stakeholders, including members of Congress, governors, federal and state government officials, industry, non-governmental organizations (NGO), and local communities. Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Ms. Bergeson counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters.
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.
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:
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.
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:
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:
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:
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:
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:
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. |
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