By Carla N. Hutton
As reported in our November 2, 2020, blog item, on October 30, 2020, the U.S. Environmental Protection Agency (EPA) issued a final rule on the Agricultural Worker Protection Standard (WPS) regulation that revises the requirements on the pesticide application exclusion zone (AEZ), defined as an “area surrounding the point(s) of pesticide discharge from the application equipment that must generally be free of all persons during pesticide applications.” The final AEZ requirements were scheduled to go into effect on December 29, 2020, but on December 28, 2020, the U.S. District Court for the Southern District of New York issued an order in the case of State of New York et al. v. EPA that resulted in a stay of the requirements. Subsequent orders have extended this stay of the effectiveness.
EPA published a May 16, 2022, Federal Register notice stating that as of February 15, 2022, the effectiveness of the WPS final rule is stayed by court order until August 22, 2022. 87 Fed. Reg. 29673. According to the notice, EPA intends to publish another document in the Federal Register to address the status of the 2020 final rule if the stay of effectiveness expires or is lifted, but EPA “does not intend to publish additional Federal Register documents to announce any additional court orders entered to further stay the effectiveness of the 2020 final rule.”
By Heather F. Collins, M.S. and Barbara A. Christianson
On January 10, 2022, the U.S. Environmental Protection Agency (EPA) announced it is opening a 60-day comment period requesting public comments on the sixth proposed rule in an ongoing series of revisions to the pesticide crop grouping regulations.
EPA states it is proposing revisions to its pesticide tolerance crop grouping regulations, which allow the establishment of tolerances for multiple related crops based on data from a representative set of crops. EPA proposes to amend the following crop groups:
- Crop Group 6: Legume Vegetables;
- Crop Group 7: Foliage of Legume Vegetables;
- Crop Group 15: Cereal Grains; and
- Crop Group 16: Forage, Fodder, and Straw of Cereal Grains.
The proposed rule includes changes to the terminology in the names of Crop Groups 6, 7, and 16 and the addition of commodities and modifications that increase efficiencies in assessing the risks of pesticides used on crops grown in and outside of the United States. The crop groups will now include certain minor or specialty crops, many of which have become more popular since the crop groups were first established.
EPA sets the maximum amount of a pesticide allowed to remain in or on a food (tolerances) as part of the process of regulating pesticides that may leave residues in food. Crop groups are established when residue data for certain representative crops are used to establish pesticide tolerances for a group of crops that are botanically or taxonomically related. Representative crops of a crop group or subgroup are those crops whose residue data can be used to establish a tolerance for the entire group or subgroup.
According to EPA, these revisions will:
- Enhance EPA’s ability to conduct food safety evaluations for tolerance-setting purposes;
- Promote global harmonization of food safety standards;
- Reduce regulatory burden; and
- Ensure food safety for agricultural goods.
Comments on the proposed rule are due on or before March 11, 2022, in docket EPA-HQ-OPP-2006-0766 at www.regulations.gov.
Bergeson & Campbell, P.C. (B&C®) is pleased to provide our Forecast 2022 to FIFRA Blog readers, offering our best informed judgment as to the trends and key developments we expect to see in the new year. For the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP), 2021 was a full year of working from home while addressing ongoing priorities; continuing the march toward meeting the 2022 deadline for registration review of pesticides registered before 2006; attempting to comply with the requirements of the Endangered Species Act (ESA); and meeting Pesticide Registration Improvement Act (PRIA) deadlines for registration applications. OPP is expected to focus on long-standing challenges, especially a renewed effort to meet ESA consultation requirements and to meet core pesticide registration review obligations. More details on this, and expected regulatory changes of all varieties, are available in our Forecast for U.S. Federal and International Chemical Regulatory Policy 2022.
“What to Expect in Chemicals in 2022”
January 26, 2022, 12:00 p.m. EST
B&C will be presenting a complimentary webinar, “What to Expect in Chemicals in 2022,” focusing on themes outlined in the forecast. Join Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Director of Chemistry; and James V. Aidala, Senior Government Affairs Consultant, for this informative and forward-looking webinar.
By James V. Aidala and Barbara A. Christianson
On October 7, 2021, U.S. Environmental Protection Agency (EPA) Administrator Michael S. Regan announced the appointment of Rod Snyder to become EPA’s Agriculture Advisor. Snyder will lead outreach and engagement efforts with the agricultural community for EPA.
Snyder is nationally recognized for his leadership at the intersection of agricultural and environmental policy, and joins EPA after serving as president of Field to Market: The Alliance for Sustainable Agriculture, the largest multi-stakeholder initiative working to advance the sustainability of commodity crop farming in the United States. In that role, he forged science-based consensus among stakeholders across the food and agriculture value chain on issues such as climate change, water quality, biodiversity, and pest management.
Prior to his time at Field to Market, Snyder worked for the National Corn Growers Association and CropLife America. He previously organized farmer delegations to participate in UN Climate Summits in Paris and Copenhagen. In 2015, Snyder co-founded the Sustainable Agriculture Summit, which has grown to be the largest and most prominent annual sustainable agriculture conference in North America. Snyder holds a B.A. in Political Science from Eastern University in St. Davids, Pennsylvania.
This position is important in the Office of the EPA Administrator. It allows stakeholders interested in issues that affect agriculture or agricultural policies a central contact point within the Administrator’s office. EPA in all program areas has a large number of interested stakeholders, but agricultural groups may be less likely to focus on EPA activities across all of the EPA media programs. This position facilitates outreach to agricultural stakeholders who might otherwise not realize they may have an interest in certain EPA policies (example, hazardous waste), in addition to those issues with a more obvious impact on agriculture (renewable fuel policies, pesticides, non-point pollution). Given the Biden Administration emphasis on addressing climate change, agricultural interests are expected to play a role in advocating “climate positive” agriculture policies, and could be affected by EPA’s climate initiatives.
The Agriculture Advisor position has potential to provide EPA leadership with input from stakeholders who otherwise may not typically focus on EPA activities. The impact of such input on EPA subsequent actions varies widely across different Administrations. Some Administrations leave the position vacant altogether. Outside groups will be interested in how influential this office will be for the current Administration.
By Lisa M. Campbell and Lisa R. Burchi
On September 29, 2021, the U.S. Environmental Protection Agency (EPA) announced developments in its efforts to address per- and polyfluoroalkyl substances (PFAS) in the environment. In particular, EPA provided an update on its progress in testing pesticide products and containers for PFAS.
EPA states that as part of its ongoing efforts, it is releasing an internally validated method for the detection of 28 PFAS compounds in oily matrices, such as pesticide products formulated in oil, petroleum distillates, or mineral oils. According to EPA, the oily matrix method is modified from EPA Method 537.1, a method that is mainly used for drinking water and was previously used in analyzing PFAS in fluorinated high-density polyethylene (HDPE) containers.
The new method is intended to assist pesticide manufacturers, state regulators, and other interested stakeholders in testing oily matrix products for PFAS and joining efforts to detect any possible contamination. In the announcement, EPA states: “In a shared interest to remove PFAS from the environment, if companies find PFAS in their product, EPA is requesting that they engage in good product stewardship and notify the Agency.”
In developing this method, EPA collaborated with the Maryland Department of Agriculture. As part of this collaboration, the method was used to analyze three stored samples of mosquito control pesticide products as well as samples obtained directly from the product line from the pesticide manufacturer. EPA determined that none of the tested samples contained PFAS at or above EPA’s method limit of detection.
EPA states that its investigation continues to determine the scope of this issue and its potential impact on human health and the environment. EPA acknowledges that “[t]o date, the only PFAS contamination in mosquito control pesticide products that the Agency has identified originated from fluorinated HDPE containers used to store and transport a different mosquito control pesticide product.” EPA will continue to test additional fluorinated containers to determine whether they contain and/or leach PFAS and will present those results when the studies are complete. EPA further states it is working with other federal agencies and trade organizations to raise awareness of this issue and discuss expectations of product stewardship. EPA also is encouraging the pesticide industry to explore alternative packaging options, such as steel drums or non-fluorinated HDPE.
Additional information on EPA’s oily matrix method report and information on PFAS in pesticide packaging is available here.
By Lara A. Hall, MS, RQAP-GLP and Heather F. Collins, M.S.
On March 17, 2021, the U.S. Environmental Protection Agency (EPA) announced the issuance of the final guidance document entitled "Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals & Supporting Retrospective Analysis" (EPA 705-G-2020-3722; Docket ID: EPA-HQ-OPP-2016-0093) that expands the potential for data waivers for acute dermal studies to single technical active ingredients (AI) used to formulate end-use products. This new guidance builds upon the final guidance for waiving acute dermal toxicity tests for pesticide formulations published by EPA on November 9, 2016, and is an example of EPA’s continued efforts to reduce animal testing and achieve its goal of eliminating all EPA requests for studies and EPA funding of studies on mammals by 2035. EPA states that this guidance is expected to reduce the number of test animals used annually by approximately 750, as well as save EPA, industry, and laboratory resources.
The new final guidance document also allows EPA to harmonize with the Pest Management Regulatory Agency (PMRA) of Canada, which published guidance on acute dermal toxicity waivers for both end-use product formulations and technical chemicals in 2017.
In developing the new guidance, EPA states that the Office of Pesticide Programs (OPP) and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) conducted a retrospective analysis of rat acute oral and acute dermal LD50 studies for 249 AIs across numerous chemical classes and toxicity categories in the EPA pesticide categorization scheme. The overall purpose of this analysis was to address the utility of the acute dermal toxicity study for single AIs in pesticide labeling, such as the signal word and precautionary statements. Fumigants and rodenticides were excluded from this retrospective analysis based on their physical state and/or anticipated exposures to them. EPA concluded that:
- For 67 percent of the 249 technical chemicals, the results of both oral and dermal acute toxicity studies fall within the same Toxicity Category;
- For 32 percent of the chemicals, the oral study falls within a lower (i.e., more protective) Toxicity Category;
- Thus, for 99 percent of the chemicals in the analysis, if the dermal study had not been available and labeling had been based only on the Toxicity Category for the oral acute toxicity study, the labeling requirements would have been equally or more protective;
- For the two remaining chemicals (less than 1 percent), factors other than the dermal acute toxicity may influence labeling requirements; and
- The acute dermal toxicity studies provide little to no added value in regulatory decision making.
EPA states that it believes the retrospective analysis fully supports the conclusion that waivers may be granted for acute dermal toxicity studies for pesticide technical chemicals, except for fumigants and rodenticides. Waivers may be accepted for fumigants and rodenticides on a case-by-case basis with appropriate scientific rationale. EPA maintains the ability to request acute dermal toxicity data on a case-by-case basis, but states that it anticipates granting the waiver in most cases.
Additional information on EPA’s efforts to reduce animal testing is available here.
By Jason E. Johnston
On November 6, 2020, the U.S. Environmental Protection Agency (EPA) published a final rule in the Federal Register that makes several changes to “Crop Group 19: Herbs and Spices Group.” 85 Fed. Reg. 70976. The original proposed rule, which was published on August 27, 2019 (84 Fed. Reg. 44804), was created in response to a petition developed by the International Crop Grouping Consulting Committee (ICGCC) workgroup that was submitted by the Interregional Research Project Number 4 (IR-4). EPA received comments from eight entities and revised the original proposed rule in response to those comments.
The major components of the new rule are a revision of the commodity definition for marjoram; the addition of three new commodity definitions for basil, edible flowers, and mint; and replacement of the existing “Crop Group 19: Herbs and Spices Group” with two new expanded crop groups, “Crop Group 25: Herb Group” and “Crop Group 26: Spice Group.” Recognizing that the existing combined Crop Group 19 Herbs and Spices Group limited the establishment of crop group tolerances, EPA created the two new separate crop groups to benefit herb and spice growers. EPA states that the anticipated economic benefit of the new crop groups is estimated to be a cost savings of $51.8 million annually.
The crop groups in the final rule include even more commodities than those listed in the proposal. Crop Group 25 includes 418 herb commodities directly and 25 indirectly through the modification of the definition of edible flowers in 40 C.F.R. Section 180.1. Crop Group 26 includes 205 spice commodities. The final rule specifies all commodities in the new crop groups and the subgroups therein (i.e., 25A and 25B for fresh herbs and dried herbs) and provides updated representative commodities for each crop group and subgroup. The effective date of the final rule is January 5, 2021.
By Heather F. Collins, M.S. and Barbara A. Christianson
On November 4, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the release of an updated list of pests of significant health importance for public review and comment. 85 Fed. Reg. 70146.
EPA, in coordination with the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA), identifies pests of significant public health importance, and in coordination with the Public Health Service, develops and implements programs to improve and facilitate the safe and necessary use of chemical, biological, and other methods to combat and control such pests of public health importance. According to EPA, the list serves as a tool for private and public organizations, including local or state governments, departments of public health, pesticide registrants, and non-governmental organizations, when making decisions and plans about future public health actions.
Since this list’s original publication in 2002, new vector-borne diseases have been identified and pests that had been previously thought of as benign or nuisance pests have been found to impact adversely public health. EPA, CDC, and USDA collaborated to update the list to incorporate significant changes regarding vector-borne diseases and related research, and eliminate gaps or ambiguities in the current pests list.
EPA states in the notice that the draft Pesticide Registration (PR) Notice 2020-X more precisely describes both the pests and expected public health impacts and adds several new pests (the brown dog tick) and public health impacts (Zika fever and coronaviruses like SARS-CoV-2) and that other pests have been renamed or grouped with similar species or removed altogether (hobo spider).
Draft PR Notice 2020-X describes the groups of pests and their potential impact on public health as follows:
- Arthropods: The listed arthropods may cause asthma or trigger allergies, contaminate food, irritate skin, cause direct injury, or carry diseases such as epidemic typhus, trench fever, epidemic relapsing fever, malaria, encephalitis (St. Louis, Eastern, Western, West Nile, and LaCrosse), yellow fever, dengue fever, and many others.
- Vertebrates: The listed organisms have the potential for direct human injury and can act as disease reservoirs for rabies and other diseases. The rats and mice include those that spread rodent-borne diseases and contaminate food for human consumption.
- Microorganisms and acellular particles: This category includes listed bacteria, fungi, protozoans, viruses, virusoids, and prions. The microorganisms and acellular particles listed in this category cause diseases such as COVID-19, cholera, meningitis, Legionnaire’s Disease, and many others.
The complete list of pests is identified in draft PR Notice 2020-X in Appendix A.
EPA states that the list does not affect the regulatory status of any registration or application for registration of any pesticide product.
Comments on the draft PR Notice are due on or before January 4, 2021, in Docket EPA-HQ-OPP-2020-0260.
This week's All Things Chemical™ Podcast will be of interest to readers of the Pesticide Law & Policy Blog®. A brief description of the episode written by Lynn L. Bergeson is below.
This week, I sat down with Lisa Campbell, my Partner here at Bergeson & Campbell (B&C®) and its consulting affiliate, The Acta Group (Acta®), and a well-recognized expert on all things regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). With so much attention focused on registering new products to combat COVID-19, we thought it timely to check in again with the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) and see what it is up to. OPP has been extraordinarily busy since March keeping up with new products to combat the coronavirus and forging new ways of leveraging its resources while maximizing the public health benefits of these new products.
We also discuss the government’s heightened interest in ensuring that marketers of products -- new and existing -- are precluded from placing products on the market that EPA believes are not effective against COVID-19, when they are promoted as effective against the virus. EPA has been quite aggressive in ensuring that products that claim to be effective in fact are effective.
We then update our listeners on a few other OPP developments unrelated to the pandemic, as OPP’s jurisdiction extends far beyond approving new products to address COVID-19.
ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.
©2020 Bergeson & Campbell, P.C. All Rights Reserved
By Lisa M. Campbell, Lara A. Hall, MS, RQAP-GLP, and Heather F. Collins, M.S.
On October 7, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is requesting comments on its draft guidance that would allow registrants, in certain circumstances, to forgo testing chemicals on animal skin to determine whether a pesticide would lead to adverse effects. This new draft guidance is part of EPA’s continued efforts to reduce animal testing and achieve its goal of eliminating all EPA requests for studies and EPA funding of studies on mammals by 2035.
According to EPA, the draft dermal toxicity guidance would allow applicants to request waivers for acute dermal toxicity studies on single-active ingredients used to develop end-use products. The new draft guidance also allows EPA to harmonize with the Pest Management Regulatory Agency (PMRA) of Canada, which published guidance on acute dermal toxicity waivers for both formulations and technical chemicals in 2017. The draft guidance is in addition to the final guidance for waiving acute dermal toxicity tests published by EPA in November 2016 for pesticide formulations.
In developing the guidance, EPA states that it conducted a retrospective analysis of rat acute oral and acute dermal LD50 studies for 249 active ingredients across numerous chemical classes and toxicity categories. Fumigants and rodenticides were excluded from this analysis, based on their physical state and/or anticipated exposures to them. EPA concluded that for 67 percent of the 249 technical chemicals, the results of both oral and dermal acute toxicity studies fall within the same Toxicity Category. For 32 percent of the chemicals, the oral study falls within a lower (i.e., more protective) Toxicity Category; thus, for 99 percent of the chemicals in the analysis, if the dermal study had not been available and labeling had been based only on the Toxicity Category for the oral acute toxicity study, the labeling requirements would have been equally or more protective. For the two remaining chemicals (less than 1 percent), factors other than the dermal acute toxicity may influence labeling requirements. EPA concluded that its requirements for such acute dermal toxicity studies provide little to no added value in regulatory decision making. EPA states that this guidance, when finalized, is expected to reduce the number of test animals used annually by approximately 750, as well as save EPA, industry, and laboratory resources.
EPA states that it believes the retrospective analysis fully supports the conclusion that waivers may be granted for acute dermal toxicity studies for pesticide technical chemicals, except for fumigants and rodenticides. Waivers may be accepted for fumigants and rodenticides on a case-by-case basis with appropriate scientific rationale. Once the guidance is issued in final form, EPA states that applicants who wish to pursue waivers for these studies would submit formal waiver requests as part of the registration application through existing processes and cite the guidance as support for the requests. EPA maintains the ability to request acute dermal toxicity data on a case-by-case basis, but states that it anticipates granting the waiver in most cases.
Comments on the draft guidance are due on or before November 9, 2020, and can be submitted at http://www.regulations.gov under Docket ID No. EPA-HQ-OPP-2016-0093.
EPA also announced the launch of its new webpage that provides metrics and strategies for reducing and replacing animal testing, including links and resources to all pertinent guidance and work plans tied to the larger Toxicology in the 21st Century Initiative across the federal government. The directive, issued by EPA Administrator Andrew Wheeler in September 2019, calls for EPA to reduce animal testing and to reduce funding 30 percent by 2025 and eliminate it by 2035. EPA states that its actions to date to support these efforts include:
- In September 2019, EPA announced $4.25 million in funding for five universities to research and develop alternative test methods for evaluating chemical safety.
- In December 2019, EPA convened a conference for achieving reduced animal testing in chemical safety research and updated its list of New Approach Methodologies (NAM) that could be used in EPA’s work under the amended Toxic Substances Control Act, including adding 21 new test guidelines related to health and ecological effects and six additional EPA policies that reduce the use of animal testing.
- In June 2020, EPA released a NAMs work plan that details how EPA plans to develop, test, and apply chemical safety testing approaches without the use of animals.
- In February 2020, EPA issued final guidance waiving the subacute dietary testing of pesticides on birds when the additional information is unnecessary to support a pesticide registration decision, which is expected to save 720 test animals annually.
- In July 2020, EPA announced new guidance to reduce unnecessary testing on fish, which is expected to save 240 test animals annually.
EPA will host its Second Annual Conference on the State of the Science on Development and Use of NAMs for Chemical Safety Testing virtually on October 19 and 20, 2020. Additional information on EPA’s efforts to reduce animal testing is available here.