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The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is a complicated and often misunderstood law. Its critical importance to the food and agricultural sectors of the global economy knows no bounds, however, and the business of pesticides is central to those sectors’ successes. State pesticide programs are also important, and increasingly a part of the commercial process in states beyond California and New York.
The FIFRA registration process through which the U.S. Environmental Protection Agency (EPA) approves pesticide products is protracted, and often challenging, for any given product. Further complicating matters are the ensuing — often expensive — data, recordkeeping, and advocacy requirements associated with obtaining FIFRA product approvals. The strategic planning that is critical to global product development requires a combination of skills, including scientific, business, and policy experience.
What We Do
Acta professionals routinely advise clients on a full range of FIFRA issues, including registration, reregistration, compliance, and defense. Our FIFRA work includes the following:
- Product Registration and Registration Review
- Assist clients across registration and registration review issues, such as:
- Pesticide Registration Improvement Extension Act of 2022 (PRIA 5) matters
- Registration Review decision documents
- Data submission requirements
- State registration requirements, including but not limited to those of the California Department of Pesticide Regulation
- Assist clients across registration and registration review issues, such as:
- Compliance
- Counsel clients on requirements for products not subject to pesticide registration but still regulated under FIFRA, including:
- Minimum risk pesticides
- Treated articles
- Pesticide devices
- Plant biostimulants (e.g., plant nutrients, fertilizers, soil amendments, vitamin hormone products)
- Counsel clients on compliance matters, including those affecting marketing materials and claims, product production requirements, recordkeeping and reporting requirements, and adverse effects reporting
- Assist companies with regulatory and contractual requirements applicable to companies that act as toll manufacturers, supplemental distributors, importers, exporters, and sellers
- Train client personnel, from management to sales and marketing personnel, on FIFRA compliance
- Counsel clients on requirements for products not subject to pesticide registration but still regulated under FIFRA, including:
- Marketing
- Counsel clients on product promotion where there are complex considerations, such as dual jurisdiction between EPA and the U.S. Food and Drug Administration (FDA) or EPA and the U.S. Department of Agriculture (USDA), avoiding FIFRA jurisdiction for cleaning products, or seeking pesticide device determinations
- Address issues affecting product marketing under EPA’s pesticide registration exemptions including treated articles and minimum risk pesticides
- Assist clients in obtaining EPA approval of expanded claims for products
- FIFRA Enforcement
- Defend products in enforcement matters involving, among other issues, allegations of sales/distributions of unregistered pesticides, misbranding of labels, noncompliance with export/import requirements, and establishment reporting
- Defend products in proceedings involving, among other issues, Notice of Refusal of Admission, Notices of Intent to Suspend, cancellations, and special reviews
- Data Compensation
- EPA/FDA Dual Jurisdiction Issues
Our Experience
Acta professionals have substantial experience in the developing regulation and policy of products implicated under FIFRA.
Lynn L. Bergeson has assisted clients for over 30 years in resolving and advocating on often precedent-setting, novel, and complex pesticide and food quality regulatory issues, including the evolving law, science, and policy of nano pesticides and biopesticides. She is a tireless and dynamic advocate for clients commercializing new chemicals with environmental, financial, and performance benefits for both industry and populations. Ms. Bergeson is Past Chair of the American Bar Association (ABA) Section of Environment, Energy, and Resources and the International Bar Association (IBA) Agriculture and Food Section.
Lisa M. Campbell has worked on some of the toughest FIFRA issues of our time, tackling the intersection of pesticide law and public policy. Ms. Campbell’s extensive work includes organophosphates, soil fumigants, commodity fumigants, antimicrobials, and other hot button FIFRA and Food Quality Protection Act (FQPA) issues. She offers an unparalleled breadth and depth of experience and expertise in finding and implementing solutions to challenging pesticide regulatory issues including exposure and risk assessment, risk communication, and related regulatory challenges.
James V. Aidala has over 30 years of experience in the field of pesticide legislation, policy, and implementation. Before joining Acta, Mr. Aidala was Assistant Administrator of EPA’s Office of Prevention, Pesticides, and Toxic Substances (OPPTS) (now the Office of Chemical Safety and Pollution Prevention (OCSPP)). Both at EPA and during earlier work for Congress’s Subcommittee on Environment, Energy, and Natural Resources, Mr. Aidala was deeply involved in FIFRA matters, in charge of oversight of EPA’s implementation of FIFRA while working on Capitol Hill.
Ryan N. Schmit served as an attorney and Senior Advisor in EPA’s OCSPP for over 15 years. He offers extraordinary insight gained during his years navigating complicated administrative and policy challenges within OCSPP’s chemical and pesticides portfolio, which he translates into practical compliance advice and creative solutions for clients.
Richard J. Fehir, Ph.D. has over 17 years of EPA service with eight years of service in antimicrobial and conventional pesticide regulation and scientific assessment under FIFRA and the Pesticide Registration Improvement Act (PRIA). Dr. Fehir served as the team leader for all antimicrobial pesticide registration review regulatory actions in the Antimicrobial Division in the Office of Pesticide Programs (OPP), and served as the supervisor of Risk Assessment Branch 6 in the Health Effects division (HED) of OPP, where he led a team of toxicologists, chemists, and exposure experts in conducting human health risk assessments and provided scientific technical expertise and leadership for conventional pesticide FIFRA and PRIA actions.
Lisa R Burchi delivers more than 25 years of skilled work on virtually every aspect of FIFRA, including registrations, establishments, FIFRA Section 6(a)(2) reporting, imports/exports, devices, treated articles, and supplemental distribution registrations. Ms. Burchi lives and is licensed in California and has extensive knowledge of California’s state regulatory system.
Lindsay A. Holden, Ph.D., DABT, is a board-certified toxicologist with an applied public health, research and development, and regulatory toxicology background under a federal agency with a global footprint. She advises clients on the application of hazard and exposure data to assess risk and develop strategic approaches to bring products to market or maintain market presence.
Meibao Zhuang, Ph.D.’s profound understanding of and experience in agricultural, biochemical, and industrial chemical product development and commercialization is invaluable to clients engaged in crop protection, seeds and traits development, and characterization of active ingredients. Dr. Zhuang assists clients with regulatory strategy development, study planning and monitoring, dossier development, active ingredient and product defense, label creation and amendment, supply chain communication, agency interaction, and project leadership of teams and processes to deliver key results for global business targets.
Heather F. Collins, MS, works with pesticide registrants to ensure FIFRA compliance, including developing biocide and pesticide registration strategies, determining data requirements, label requirements, and registration requirements for proposed products. Ms. Collins has expertise in preparing and submitting pesticide applications, preparing registration review responses, composing compliant labels, and shepherding submissions through regulatory agency review.
Kelly N. Garson assists clients with data compensation negotiations, FIFRA enforcement actions and settlement negotiations, and issues relating to EPA registration review decisions. She prepares guidance on EPA’s labeling requirements and pesticide claims and has assisted on advocacy efforts relating to EPA’s policies regarding “absence of” product claims.
Catherina D. Narigon counsels clients on a range of FIFRA matters, including policy and enforcement issues. Ms. Narigon assists clients with the often-complex process of product registration and compliance challenges at both federal and state levels.
L. Claire Hansen provides accurate and efficient research and analysis on FIFRA regulatory and policy matters to support clients’ compliance and business goals.
Dana S. Lateulere draws upon her 30 years of pesticide regulation experience, including a decade with EPA’s OPP, as she assists clients in preparing and submitting new product submissions and registration review responses, managing lab work and data procurement, and composing compliant label systems.
Lara A. Hall, MS, RQAP-GLP, assists clients through various aspects of pesticide product registration under FIFRA, including data development (study monitoring, third party quality assurance, and fate and effects modeling) and responses to EPA Data Evaluation Reports.
Scott J. Burya, Ph.D., a Regulatory Chemist with a Ph.D. in analytical chemistry, supports compliance and notification activities for biocides and antimicrobials and specializes in substance identity and exposure modelling assessments.
Representative Engagements
- ACTA is among the elite in pesticide firms representing global product manufacturers on virtually every aspect of FIFRA/FQPA law, policy, science, and regulation.
- ACTA assists both large and small product manufacturers and trade associations in tackling the daunting array of scientific and policy challenges confronting the agricultural chemical, antimicrobial, and biochemical communities. ACTA professionals are intimately familiar with the legislative underpinnings of FIFRA and FQPA, and they continue to work on legislative matters arising under FIFRA, the Clean Water Act (CWA), the Endangered Species Act (ESA), PRIA, and other laws applicable to pesticide, antimicrobial, and biochemical practices.
- ACTA successfully negotiates significantly reduced penalties in enforcement actions for allegations of non-compliance.
- ACTA’s expertise extends to registration and related responsibilities as required in each state in which a pesticide product is sold or distributed. California is one example of a state imposing additional or distinct requirements for state registration (e.g., data development, label restrictions) and other state-specific requirements, including Proposition 65 and pesticide mill assessments.
- ACTA routinely assists data owners in protecting and optimizing their financial investment in FIFRA registration data relied upon by follow-on registrants and in negotiating data compensation settlements or assisting in data compensation arbitrations when settlement is not an option.
- ACTA successfully reversed an EPA decision to cancel certain tolerances applicable to an herbicide, persuading EPA that continued use of the product was essential to agriculture and had no replacement.
- ACTA professionals have procured countless successes for clients in obtaining novel registrations, continuing challenged registrations, and/or diminishing the regulatory constraints on existing registered products.