Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.
On November 19, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is extending COVID-19 activation of the emerging viral pathogens (EVP) guidance for antimicrobial pesticides indefinitely. EPA states that its EVP guidance for antimicrobial pesticides is a part of the federal government’s pandemic preparedness, allowing manufacturers to provide EPA with data, even in advance of an outbreak, demonstrating that their products are effective against hard-to-kill viruses.
EPA activated its EVP guidance for antimicrobial pesticides for the first time in January 2020 in response to the emergence of SARS-CoV-2. EPA has allowed for expedited review and approval of surface disinfectant products for use against SARS-CoV-2 for more than 12 months, including accelerated review for products seeking to add EVP claims to product labels. To date, EPA has added 591 products with emerging viral pathogens claims to its list of Disinfectants for Coronavirus (List N).
EPA states that registrants must remove EVP claims from consumer messaging no later than 24 months after the original notification of the outbreak, unless directed otherwise by EPA. With this extension, EPA will now provide a notification at least six months before inactivating the EVP guidance for SARS-CoV-2 to allow registrants time to adjust product marketing materials as required.
Additional information on the EVP guidance is available here.
Bergeson & Campbell, P.C. (B&C®) is pleased to announce that FIFRA Tutor™ regulatory training courses are now available at www.FIFRAtutor.com. Professionals can preview and enroll in on-demand classes to complete at their own pace and timing. FIFRA Tutor joins B&C’s existing TSCA Tutor® training courses in offering efficient and essential training for chemical regulatory professionals, and a third training program, HazCom GHS Tutor, is planned for 2022.
Additional modules in the FIFRA Tutor curriculum will be released throughout 2022.
Courses can be completed at the learner’s own pace, and enrollment is valid for one full year. Interested professionals should visit www.FIFRAtutor.com to view sample course segments and purchase modules.
Watch a preview of TSCA Tutor and FIFRA Tutor courses: T101 – TSCA Inventory Overview, T202 – TSCA Section 5 (Part 1) TSCA Chemical Inventory, Exemptions, and F109 – Defining Tolerances and Their Regulation.
Bergeson & Campbell, P.C. is a Washington, D.C., law firm focusing on conventional, biobased, and nanoscale industrial, agricultural, and specialty chemical product approval and regulation, and associated business issues. B&C represents clients in many businesses, including basic, specialty, and agricultural and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; paints and coatings; plastic products; and chemical manufacturing, formulation, distribution, and consumer product sectors. Visit www.lawbc.com for more information.
Federal Agencies Reaffirm Commitment to Protecting Endangered Species, Providing Effective Pest Control Tools, and Regulating Pesticide Use in a Fair, Transparent, and Predictable Manner
On November 3, 2021, the U.S. Environmental Protection Agency (EPA), the White House Council on Environmental Quality (CEQ), the U.S. Department of Agriculture (USDA), the U.S. Department of Commerce, and the U.S. Department of the Interior “reaffirm[ed] their commitment to working together and with stakeholders to protect endangered species, provide effective pest control tools, and regulate pesticide use in a fair, transparent, and predictable manner.” According to EPA’s November 3, 2021, press release, on October 15, 2021, all five agencies met as part of the Interagency Working Group (IWG) created under the 2018 Farm Bill to discuss improvements to the consultation process for pesticide registration and registration review under Section 7 of the Endangered Species Act (ESA). EPA states that the group’s first meeting resulted in specific commitments to improve the pesticide consultation process for endangered species and engaging stakeholders, including by capitalizing on the strong interest among stakeholders for a workable process.
According to the press release, the IWG is optimistic about its ability to collaborate on improvements that the Biden Administration can implement. The IWG’s actions focused on improving processes that will contribute to tangible benefits for species conservation and for stakeholders. EPA states that the IWG “is intent to adopt improvements expeditiously and that endure across administrations.” To guide its future work, the IWG has identified the following initial priorities and approaches:
EPA states that “[e]ffective endangered species protection cannot be accomplished solely by federal agencies,” but also requires “open and continuous engagement with stakeholders on practical solutions to harmonizing species conservation with pesticide use.” To that end, the IWG plans to hold its first stakeholder listening session in early 2022 and will provide details on the proposed session before the end of 2021.
EPA Announces Revisions to Guidance to Ensure Effectiveness of Antimicrobial Pesticides against Candida auris
On October 15, 2021, the U.S. Environmental Protection Agency (EPA) announced that it has revised its guidance for evaluating the efficacy of antimicrobial pesticides against Candida auris (C. auris). EPA states that pesticide manufacturers seeking to register their products with a C. auris claim should use this updated guidance to test the effectiveness of the products against a drug-resistant strain of C. auris.
EPA states that C. auris is an emerging, multidrug-resistant yeast (a type of fungus). It can cause serious infections and spreads easily among hospitalized patients and nursing home residents. C. auris can spread in healthcare settings through contact with contaminated environmental surfaces or equipment, or from person to person. According to the Centers for Disease Control and Prevention (CDC), more than one in three patients with an invasive (e.g., affecting the blood, heart, or brain) C. auris infection die.
In 2017, in consultation with the CDC, EPA issued interim guidance for testing the effectiveness of hospital disinfectants against C. auris. Subsequently, based on input from the CDC on its tracking of clinical cases of multi-drug resistant C. auris isolates in the United States, the laboratory data were generated to ensure antimicrobial efficacy against a more relevant strain of the pathogen.
Working closely with experts from the CDC, EPA conducted a comparative evaluation of isolates and found that the drug-resistant isolates were more tolerant to some disinfectant treatments. Since a drug-resistant isolate (AR Bank #0385) is highly relevant to current outbreaks in the United States, it is considered a suitable test microbe for regulatory purposes.
The guidance provides recommendations for laboratory methodology on how to:
Under the updated guidance, all new products seeking registration with claims against C. auris should test for efficacy using the more relevant strain (AR Bank #0385). Efficacy testing using AR Bank #0381 is acceptable in some cases where the study initiation date is between October 15, 2020, and October 15, 2021. For study initiation dates between October 15, 2020, and October 15, 2021, EPA will accept studies conducted with isolate AR Bank #0381 for products whose active ingredients are either sodium hypochlorite or hydrogen peroxide plus acetic acid. For products with other active ingredients, it will be necessary to retest using isolate AR Bank #0385.
Existing antimicrobial products with C. auris claims based on the previous strain (AR Bank #0381) will be allowed to retain their claim of effectiveness against C. auris. To claim effectiveness against drug-resistant C. auris, EPA requires retesting with the more relevant strain (AR Bank #0385) identified in the updated guidance and according to the revised test method.
FDA Announces Withdrawal of Temporary Guidance Documents Concerning Alcohol-Based Hand Sanitizer Products
The Food and Drug Administration (FDA) published a Federal Register notice on October 13, 2021, announcing the withdrawal of three guidance documents: “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)”; “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency”; and “Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).” 86 Fed. Reg. 56960. According to the notice, FDA is withdrawing the guidance documents “because current data indicate that consumers and healthcare personnel are no longer experiencing difficulties accessing alcohol-based hand sanitizer products, and these temporary policies are no longer needed to help meet demand for alcohol-based hand sanitizer products or for alcohol for use in alcohol-based hand sanitizer.” The withdrawal date for the guidance documents is December 31, 2021. The notice states that firms manufacturing alcohol under the temporary policies for use in alcohol-based hand sanitizers and firms preparing alcohol-based hand sanitizers under the temporary policies must cease production of these products by December 31, 2021. Firms must cease, by March 31, 2022, distribution of any remaining hand sanitizer products that were prepared under the temporary policies before or on December 31, 2021. After March 31, 2022, FDA states that it intends to cease its temporary policy of not taking action with regard to distribution of hand sanitizers, or alcohol for use in alcohol-based hand sanitizers, prepared consistent with the circumstances described in the guidance documents.
The withdrawal of these documents is not unexpected. FDA issued the documents in March 2020 to provide regulatory flexibility to certain firms to help meet the demand for alcohol-based hand sanitizer during the COVID-19 public health emergency (PHE). FDA states that it has determined that the demand for alcohol-based hand sanitizer has decreased and the supply of hand sanitizer from traditional manufacturers (i.e., firms other than those that entered into the over-the-counter drug industry for the first time to supply hand sanitizers during the PHE) has increased. FDA notes that although the temporary policies are being withdrawn, firms may continue to manufacture alcohol-based hand sanitizer products without an approved application, provided they comply with the applicable tentative final monograph and other applicable requirements, including current good manufacturing practice requirements under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. FDA reminds distributors, re-packagers, and importers that they are also responsible for the safety and quality of the drugs they introduce into interstate commerce. Firms that registered and submitted drug product listing(s) for hand sanitizer(s) only but no longer manufacture such product, or plan to cease manufacturing such product, can deregister and delist their hand sanitizer product listing(s) by following the Electronic Drug Registration and Listing Instructions.
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.
EPA Region 2 Settles with Reckitt Benckiser on Violations Related to Sales of Mislabeled Rodenticides
On October 7, 2021, U.S. Environmental Protection Agency (EPA) Region 2 announced a settlement with Reckitt Benckiser, LLC (Reckitt Benckiser) regarding alleged violations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The specific alleged violations relate to 239 sales and distributions of two rodenticide products in the United States that EPA asserts had misleading advertising claims on the packaging. Reckitt Benckiser has agreed to pay a civil penalty of $458,000 under the settlement to resolve these violations.
Reckitt Benckiser is a supplemental distributor of two rodenticide products that are bait stations registered under FIFRA to kill mice. EPA states that in 2019, it conducted inspections of a Home Depot in South Plainfield, New Jersey, and Reckitt Benckiser’s offices in Parsippany, New Jersey. EPA thereafter determined that Reckitt Benckiser was selling these two rodenticide products in packaging or labeling that made comparative claims as to the effectiveness of the product. Specifically, the packaging stated that the products were “10x Tastier Than Lead Competitor.” The labels EPA approved for the two products did not contain this comparative claim language, and at the time of registration, data associated with the products’ claims were never provided. EPA’s regulations at 40 C.F.R. Section 156.10(a)(5)(iv) provide that statements or representations in the labeling which constitute misbranding include a “false or misleading comparison with other pesticides or devices.” EPA states that because "the comparative claims were not subject to verification, they were ‘false and misleading comparisons’ prohibited under [FIFRA].”
This case serves as another reminder to registrants and supplemental distributors to review all labeling and advertising claims to ensure conformity with EPA-approved labels and avoidance of claims that EPA identifies as false or misleading.
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.
The First International Conference on Agricultural Law was held jointly by the Agricultural Law Section of the International Bar Association (IBA), Project Pravo-Justice, and the Ukrainian Bar Association (UBA) on September, 23-24, 2021. This conference provided a unique review of current legal issues in agriculture, with leading European and Ukrainian experts sharing their experience on
A complimentary recording of this informative event is now available to stream. Bergeson & Campbell, P.C. (B&C®) is pleased to share this valuable resource with clients and friends. B&C Managing Partner Lynn L. Bergeson is the Senior Vice Chair of the IBA’s Agricultural Law Section.
On September 15, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is terminating the Temporary Amendment to Pesticide Registration (PR) Notice 98-10, effective September 15, 2022. EPA states that it is providing 12 months’ notice to registrants before the termination takes effect to give registrants time to adjust their contractual commitments. Registrants must ensure that by September 15, 2022, their product is produced using a source of active ingredient identified in the product’s EPA-approved Confidential Statement of Formula (CSF) or otherwise complies with the requirements of PR Notice 98-10. All notifications submitted to EPA under the temporary process are valid only for the time period of the temporary amendment. After September 15, 2022, registrants “will not be able to release for shipment formulations produced under the conditions of the temporary amendment without first complying with the registration requirements that were in place prior to the issuance of the temporary amendments.”
EPA states that this notice applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (the virus that causes COVID-19) or products that serve as the source of active ingredient for disinfectants on EPA’s List N. This notice also applies to food contact surface sanitizer products containing the active ingredient isopropyl alcohol that are used in the essential role of food manufacturer and preparation.
In 2020, EPA issued temporary amendments to PR Notice 98-10 to ensure that antimicrobial products remained available in response to the COVID-19 public health emergency. According to EPA, supply chains have stabilized and disinfectant products expected to kill SARS-CoV-2 have become consistently available to consumers, so it has determined that this flexibility is no longer needed. When the temporary amendment was issued, EPA stated it would assess the continued need for and scope of the temporary amendment to PR Notice 98-10 on a regular basis and would update it if EPA determined modifications were necessary. EPA stated it would post a notification at www.epa.gov/pesticides at least seven days prior to terminating the temporary amendment. EPA acknowledges in the termination memorandum that registrants require time to make the temporary changes permanent through CSF amendment or notification and therefore is providing 12 months, rather than the seven days guaranteed in the temporary amendment.