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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.” The U.S. Environmental Protection Agency (EPA) announced on May 11, 2022, that it is launching a new, modern Design for the Environment (DfE) logo that will appear on antimicrobial products like disinfectants and sanitizers within the next year. EPA intends the DfE logo to help consumers and commercial buyers identify antimicrobial products that meet the health and safety standards of the typical pesticide registration process required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as well as other rigorous criteria required by EPA. To qualify for the DfE logo, every ingredient in a product must meet a rigorous set of chemical and toxicological standards. EPA states that it has seen a surge of engagement in the last few years from consumers, schools, and other organizations who want to know more about how products affect their health and the environment. According to EPA, the updated logo should make DfE-certified products easier for purchasers to find, which in turn will encourage companies to seek certification for their products. DfE products meet criteria that evaluate human health and environmental effects, product performance, packaging, and ingredients. According to EPA, the requirements are intended to:
Commentary EPA notes that it does not consider the logo to be an endorsement. Instead, similar to describing a pesticide as “EPA-registered” because EPA found it meets the FIFRA registration standard, the DfE logo indicates that EPA reviewed the product and that the product meets the FIFRA registration standard, as well as the standards for the DfE program. DfE certification provides an opportunity for companies to work toward their sustainability goals. EPA provides information on how registrants can obtain DfE certification. By Lisa M. Campbell, James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson On May 6, 2022, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of, and requesting comments on, data related to aquatic toxicity of chitosan salts. 87 Fed. Reg. 27059. Specifically, EPA is seeking comments on the following two aquatic toxicity reports submitted by Tidal Vision Products, LLC (Tidal Vision), the company that submitted a petition to EPA on October 10, 2018, requesting that EPA add chitosan to the list of active ingredients eligible for EPA’s minimum risk pesticide exemption under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b):
EPA is seeking input on how these reports may be used by EPA in its assessment of aquatic toxicity of chitosan and its salts. EPA states “chitosan may form as a salt (e.g., acetate, lactate, hydrochloride, and salicylate) when it is solubilized in acids for end use product formulation and subsequently applied in the environment” and the new information submitted by Tidal Vision pertains to these salts. Comments on the aquatic toxicity reports are due on or before June 6, 2022, in Docket EPA-HQ-OPP-2019-0701. As background, EPA on August 20, 2020, announced that it was seeking to add chitosan to the list of active ingredients allowed in minimum risk pesticides that are exempt from pesticide registration requirements and was providing to the United States Department of Agriculture (USDA) for review a draft regulatory document titled ‘‘Pesticides; Addition of Chitosan to the List of Active Ingredients Allowed in Exempted Minimum Risk Pesticides Products.” A minimum risk product must meet six specific conditions to be exempt from pesticide registration. One of those conditions is that the active ingredient in the minimum risk pesticide be one that is listed specifically by EPA. If EPA adds chitosan to the list of minimum risk pesticide active ingredients, pesticide products containing chitosan could qualify as minimum risk pesticides provided the other conditions also are satisfied (e.g., using inert ingredients approved by EPA for use in minimum risk pesticides, not making any public health claims). On November 2, 2020, EPA requested comments on the proposed rule to add chitosan to the list of active ingredients eligible for the exemption. In the May 6, 2022, Notice, EPA states that comments received on the proposed rule expressed concerns regarding derivatives of chitosan that are likely to be produced when chitosan is mixed with certain acids and on the potential hazard for aquatic organisms exposed to chitosan salts. Because of the concerns raised, EPA now is requesting comments on the two aquatic toxicity reports that pertain to these salts. Commentary EPA continues to remain focused on listing this specific substance rather than address other issues related to minimum risk pesticides that have been raised by industry to EPA over many years. There is, for example, a petition filed in 2006 by the Consumer Specialty Products Association (CSPA) requesting that EPA modify the minimum risk pesticide regulations to exclude products claiming to control public health pests from the Section 25(b) exemption. Comments submitted in response to the November 2, 2020, proposed rule raise additional concerns, including but not limited to the fact that the vast majority of states now require registration of minimum risk pesticides, thus shifting the burden away from EPA with costly and potential inconsistent results. Though this EPA list is called “minimum risk,” it more accurately could be described as -- “so safe no one could, or at least should, have any concern about toxicity.” There is long-standing reluctance for EPA to call any pesticide whatsoever as “safe” for various reasons, even to the point of an outright prohibition on using the word “safe” on registered labels. (This is the clever distinction that “minimum risk” pesticides do meet the FIFRA definition of a pesticide, but the Section 25(b) designation allows that the label not be subject to EPA review and registration of the label.) This issue of possible risks from adding chitosan to the Section 25(b) list in light of the studies EPA seeks comment on appears to allow EPA to back away from its intended designation as minimum risk or to have the public comment reaffirm EPA’s assessment that chitosan’s safety profile is sufficiently beyond reproach to align with the other members of this category. There are many other pesticides considered of very low risk but not so low as to have made the Section 25(b) list until now. That there is a hint of debate about possible toxicity could signal that future additions to the list are being contemplated to encourage more “minimum risk” product development. Or more simply, it may signal EPA’s reaction to the comments received has triggered some reconsideration of how “minimum” any minimum risk needs to be to qualify for the Section 25(b) list. By Lynn L. Bergeson and Carla N. Hutton According to a May 9, 2022, news item published by the U.S. Environmental Protection Agency (EPA), “Advancing EPA’s Understanding of the Next Generation of Pesticides,” over the past decade, EPA “has received an increasing number of pesticide product applications that potentially contain nanomaterials.” The article notes that EPA’s current pesticide review method was not designed for nanomaterials, so each product is reviewed on a case-by-case basis. An EPA research team led by EPA scientist Dr. Chunming Su conducted an exhaustive search for patents and published literature related to nanopesticides to understand the state of the science. The item states that the team found and analyzed more than 36,000 patents and 500 peer-reviewed journal articles. The team established two general categories of nanopesticides to help inform EPA’s regulatory reviews: products with mostly metal-based nanomaterials as the active ingredient, like nanosilver and nanocopper oxide/hydroxide; and products that encapsulate and carry the active ingredient using nanomaterials (mostly carbon based) like graphene and carbon nanotubes. According to the item, the research team also developed a review framework “that includes a simple decision tree to determine what products should be classified and evaluated as a nanopesticide.” Products determined to contain nanomaterials are subject to additional assessment or data needs from the manufacturer. Dr. Andrew Byro of EPA’s Office of Pesticide Programs (OPP) states that the framework “represents a major steppingstone in the development of a method for identification of nanomaterials.” EPA will use this framework as a platform to help inform its data needs and future determinations regarding the evaluation of nanomaterials in antimicrobial pesticides. EPA’s research team collected their findings related to the physical and chemical properties and efficacy of nanopesticides in a peer-reviewed journal article in Nature Nanotechnology, “Nano-enabled pesticides for sustainable agriculture and global food security.” According to EPA’s news item, the team “found that nano-enabled pesticides adhere better to plant surfaces and have a reduced impact on non-target organisms. Nanopesticides may also enhance plant resilience against stressors from heat or drought.” EPA states that these benefits “could lead to higher crop yield and provide more agricultural resilience to address climate change and weather extremes.” EPA notes that the research team’s findings “also highlight the data gaps and the need for additional research on potential adverse impacts of nanopesticides.” Wednesday, May 18, 2022 A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful life. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. Working within this framework plays a critical role in building a resilient, dependable, and sustainable system that fosters innovation to develop a circular economy. Register now to join Lynn L. Bergeson, Richard E. Engler, Ph.D., Kate Sellers, and Mathy Stanislaus, as Bergeson & Campbell, P.C. (B&C®) presents “Domestic Chemical Regulation and Achieving Circularity.” Topics Covered:
Speakers Include: Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to industrial biotechnology, synthetic biology, and other emerging transformative technologies. She 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. Richard E. Engler, Ph.D., Director of Chemistry, B&C, is a 17-year veteran of the U.S. Environmental Protection Agency (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. His expansive understanding of the specific challenges and opportunities that TSCA presents for green and sustainable chemistry is a powerful asset for clients as they develop and commercialize novel chemistries. Kate Sellers, Technical Fellow at ERM, leads a multi-disciplinary team of professionals dedicated to helping companies recognize the business value of product stewardship. Over the past year, Kate has seen an uptick in several product sustainability trends, including implementation of the TSCA life-cycle assessment, circular economy programs, and sustainability initiatives. In addition to her consulting work, Kate teaches “Product Stewardship and Chemical Sustainability” at Harvard University Mathy Stanislaus, was recently appointed as Vice Provost and Executive Director of Drexel University’s Environmental Collaboratory, bringing interdisciplinary expertise in environmental sciences, engineering, law, health, business, economics, policy, and humanities to co-design transformative environmental solutions. Stanislaus joined Drexel from the Global Battery Alliance (GBA), a multi-stakeholder initiative established at the World Economic Forum (WEF), where he served as its first interim director and policy director with a focus on establishing a global transparent data authentication system to scale up electric mobility and clean energy. He also led the establishment of the Platform for Accelerating Circular Economy at WEF. Mathy served for eight years as the Senate-confirmed Assistant Administrator for EPA’s Office of Land & Emergency Management for the Obama Administration, leading programs to revitalize communities through the cleanup and redevelopment of contaminated sites, hazardous and solid waste materials management, chemical plant safety, and oil spill prevention and emergency response. During this Administration, he led the establishment of the G7 Alliance for Resource Efficiency that focused on the opportunities in the supply chain to drive circularity and de-carbonization. By Lisa M. Campbell and Lisa R. Burchi Background OEHHA’s proposal to adopt a new safe harbor warning regulation to address the content of warnings for exposure to glyphosate in consumer products is not without controversy. OEHHA’s initial listing of glyphosate as a substance known to the state to cause cancer was challenged in court. In the 2020 decision for National Association of Wheat Growers et al. v. Becerra et al., the District Court found that the Proposition 65 (Prop 65) safe harbor warning was false and misleading commercial speech under the First Amendment and enjoined enforcement of the warning requirement. More information regarding that decision is discussed in our blog. In addition, in 2019, the U.S. Environmental Protection Agency (EPA) issued a letter stating that it would not approve labeling that includes the Prop 65 warning statement for glyphosate-containing products and that any such warnings would be considered false and misleading and thus misbranding violations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Additional information regarding EPA’s determination is discussed in our blog. OEHHA’s safe harbor regulations are nonmandatory guidance. OEHHA does not have enforcement authority under Proposition 65 and thus cannot require warnings to be given for an exposure to any listed chemical, including glyphosate. The injunction in the National Wheat Growers case is still in effect. Therefore, no enforcement actions can be taken against businesses who do not provide warnings for significant exposures to this chemical. OEHHA does not intend to suggest otherwise by proposing this regulatory action. OEHHA states further (ISOR page 15): OEHHA has determined that a tailored safe harbor warning for significant glyphosate exposures from consumer products can provide clear and factual and information for the benefit of those who could be exposed. As discussed above, where no consumer product warning is being given under FIFRA for significant exposures to glyphosate, the safe harbor language provides content and methods that businesses can use to provide a warning if they choose to do so. Also, under OEHHA’s implementing regulations, a business that determines it must provide a warning for a worker exposure that is not required under FIFRA may use the proposed consumer product safe harbor content and methods to provide the warning, if appropriate. (Section 25606(a)). Summary of Proposed Modifications OEHHA is modifying proposed Section 25607.49, subsection (a)(3) as shown below. Additions and deletions to the proposed text are shown in double-underline ( (3) The words, “Using this product can expose you to glyphosate. The International Agency for Research on Cancer classified glyphosate as probably carcinogenic to humans. A copy of the full proposed regulatory text (new sections 25607.48 and 25607.49), reflecting the modification, is available here. Documents Added to the Record In the interest of completeness and in accordance with Government Code Section 11347.1, subdivision (a), OEHHA also has added to the rulemaking record the following documents to those it relies in this rulemaking:
Copies of these materials are available through the links provided above or here on OEHHA’s website. Commentary While the District Court decision enjoins enforcement of any Prop 65 warning requirement for glyphosate, OEHHA stated when it initially proposed the warning language for glyphosate that businesses are not enjoined from providing a warning if they choose to do so. Although OEHHA is proposing slight modifications to the warning language, these modifications do not squarely address the significant concerns raised regarding the initial proposal to the extent that the proposed warning, even as modified, could be considered false and misleading statements under the First Amendment and/or FIFRA. EPA’s April 8, 2022, letter indicates that OEHHA’s modifications to the warning language would be approvable as language that EPA does not consider to be false and misleading should a registrant propose it. If this regulation is approved, it appears that EPA would not reject any label amendments from registrants seeking to add the warning. By Heather F. Collins, M.S. and Barbara A. Christianson On April 15, 2022, the U.S. Environmental Protection Agency (EPA) announced final product performance data requirements for products claiming efficacy against certain pests. 87 Fed. Reg. 22464. This action officially incorporates EPA’s already existing product performance standards requirements for certain invertebrate pests into the Code of Federal Regulations (CFR). EPA states this action also increases the efficiency of its approval process and will save registrants time and money. Product performance standards are intended to make it easier for pesticide registrants to know the efficacy data that EPA requires to demonstrate that a pesticide product works as claimed. By adding these requirements into the CFR, EPA states that it intends to help ensure that submitted data meet EPA’s needs and scientific standards and satisfy a requirement of the 2018 Pesticide Registration Improvement Extension Act (PRIA 4). EPA notes as part of the agreement between pesticide stakeholders and public interest groups reflecting the environmental and farmworker safety communities in the development of PRIA, “PRIA 4 specifically establishes a new maintenance fee set-aside of up to $500,000/year to develop and finalize rulemaking and guidance for product performance data requirements for certain invertebrate pests of significant public health or economic importance. Specific to this rule, PRIA 4 requires EPA to finalize product performance data requirements by September 30, 2021, for certain pesticides intended for preventing, destroying, repelling, or mitigating specified invertebrate pest of significant public health or economic importance.” This final rule includes product performance data requirements for the categories of invertebrate pests specified in PRIA 4, which EPA states it intends to satisfy the rulemaking requirement. EPA notes that this final rule covers some invertebrate pests in addition to those specified in PRIA 4 due to their public health, economic, or ecological significance (e.g., wood destroying insects). EPA states that it believes this final rule will save registrants approximately $17,000 per data package submitted to EPA by reducing waste and unnecessary testing, and believes it will reduce burden hours by 4,683 annually, including 4,515 hours from reduced paperwork burden associated with data generation and 168 hours from reduced paperwork with the application process. This final rule codifies product performance data requirements to support registration of products claiming efficacy against three categories of invertebrate pests:
EPA states that the latter two categories are pests considered to be of significant economic or ecological importance. The final rule is effective on June 14, 2022. Commentary Codifying the product performance data requirements for invertebrate pests should increase transparency to registrants regarding the efficacy data that they typically would need to generate and submit for products to make labeling claims against these specific pests. Registrants of the products at issue should monitor these requirements closely. Bergeson & Campbell, P.C.’s (B&C®) April 20, 2022, webinar “FIFRA Hot Topics” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/7426709986449689102. During this one-hour webinar, Lisa M. Campbell, Partner, B&C, moderated a lively and informative discussion between Edward Messina, Director, U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP), and James V. Aidala, Senior Government Affairs Consultant, B&C, as they discussed key OPP developments and priorities. By Lynn L. Bergeson and Carla N. Hutton The U.S. Environmental Protection Agency (EPA) announced on April 18, 2022, that it will hold a webinar on May 11, 2022, entitled “Data-Driven Solutions to Reducing Animal Use in Ecotoxicity.” Speakers will include:
The webinar is co-organized by the People for the Ethical Treatment of Animals (PETA) Science Consortium International, EPA, and the Physicians Committee for Responsible Medicine (PCRM). EPA notes that it does not necessarily endorse the views of the speakers. Registration is now open. Wednesday, April 20, 2022 Register now to join Bergeson & Campbell, P.C. (B&C®) for “FIFRA Hot Topics,” a complimentary webinar covering key Office of Pesticide Programs (OPP) priorities and what companies should know to avoid market delays. Speakers include:
Program:
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