PRACTICES

Pesticide Regulation under FIFRA

FIFRA Law and Policy Blog®

Overview:

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 product approval process 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 legal, scientific, business, and policy experience.

The legal and scientific professionals at Bergeson & Campbell, P.C. (B&C®) know federal and pertinent state law well, and know how to use it to achieve competitive advantage for their clients. B&C professionals have it all and are well-suited to assist innovators to monetize their creations and to guide new and existing registrants and follow-on registrants in these complex legal, policy, and commercial challenges.

Our Experience:

B&C professionals have substantial experience in the developing law, 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. Ms. Bergeson is engaged in the evolving law, science, and policy of nano pesticides and biopesticides.

Lisa M. Campbell has worked on some of the toughest FIFRA legal 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.

Lisa R. Burchi delivers more than 18 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 registrations. Ms. Burchi lives and is licensed in California and has extensive knowledge of California's state regulatory system.

James V. Aidala has over 30 years of experience in the field of pesticide legislation, policy, and implementation. Before joining B&C, 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.

Dennis R. Deziel provides the firm’s clients with an extraordinary depth of experience and knowledge of the regulatory process and government advocacy. Mr. Deziel honed his skills through a career of senior leadership roles, including as EPA Administrator of Region 1 (New England); Deputy Assistant Secretary at the U.S. Department of Energy (DOE); chemical security director of the U.S. Department of Homeland Security; and Director of Federal Government Affairs at The Dow Chemical Company.

Heather F. Collins, M.S., works with pesticide producers to ensure FIFRA compliance, including determining data requirements, label requirements, and registration requirements. Ms. Collins has specific expertise in biocide and pesticide compliance strategies under FIFRA, and has established training programs and provided training to ensure applicable federal and state laws and regulations are followed.

Dana S. Lateulere draws upon her 30 years' of pesticide regulation experience, including a decade with the EPA Office of Pesticide Programs (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.

Jane Vergnes, Ph.D., DABT®, has 25 years of toxicology and product stewardship experience with major international chemical companies that manufacture FIFRA-regulated products. She is a tremendous asset to those clients needing data review and interpretation, study monitoring, hazard characterization, or assistance in preparing data for submission to EPA.

Todd J. Stedeford, Ph.D., DABT®, ERT, ATS, delivers exceptional legal acumen and scientific experience to clients registering and defending pesticide products. Dr. Stedeford most recently served as Senior Science Advisor/Senior Leader, Office of Pollution Prevention and Toxics (OPPT), OCSPP. Previous positions include Acting Chief, Chemical Risk and Reporting Enforcement Branch, Waste and Chemical Enforcement Division, Office of Civil Enforcement (OCE), and Chief of Assessment Branch 2 for New and Existing Chemicals, Risk Assessment Division, OPPT.

Lara Hall, M.S., 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, managed compliance and notification activities for biocides and antimicrobials used in antifouling and industrial coatings for a multinational coating manufacturer. Dr. Burya specializes in reviews and quantitative risk assessments.

B&C also draws on the skills and expertise of our consulting affiliate, The Acta Group (Acta®), for product registration issues under U.S., Canadian, European, and Asian law.

What We Do:

B&C 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, Reregistration, and Registration Review -
    • Assist clients across registration, reregistration, and registration review issues, such as:
      • Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) matters
      • Reregistration Eligibility Decision (RED) and Registration Review decision documents
      • California and other state registration requirements
  • Compliance -
    • Counsel clients on compliance matters, including those affecting marketing materials and claims, product production requirements, recordkeeping and reporting requirements, and data submission requirements
    • Train client personnel, from management to sales and marketing personnel, on FIFRA compliance
  • Marketing -
    • Counsel clients on product promotion that is EPA and U.S. Food and Drug Administration (FDA) compliant
    • Address legal issues affecting product marketing under EPA's treated article exemption
    • Assist clients in obtaining EPA approval of expanded claims for products
  • FIFRA Enforcement -
    • Defend products in enforcement matters involving, among other issues: labeling, export/import, and experimental use permits
    • Defend products in proceedings involving, among other issues: Notices of Intent to Suspend, cancellations, and special reviews
  • Data Compensation
  • EPA/FDA Dual Jurisdiction Issues

Representative Engagements:

  • B&C is among the elite in pesticide law and policy firms representing global product manufacturers on virtually every aspect of FIFRA/FQPA law, policy, science, and regulation.
  • B&C assists both large and small product manufacturers and trade associations in tackling the daunting array of scientific, legal, and policy challenges confronting the agricultural chemical community. B&C professionals are intimately familiar with the legislative underpinnings of FIFRA and FQPA, and continue to work on legislative matters arising under FIFRA, the Clean Water Act (CWA), the Endangered Species Act (ESA), the Pesticide Registration Improvement Act (PRIA), and other laws applicable to agricultural practices.
  • B&C’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.
  • B&C 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.
  • B&C 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.
  • B&C professionals have procured countless successes for clients in obtaining novel registrations, continuing challenged registrations, and/or diminishing the regulatory constraints on existing registered products. For instance, B&C obtained the landmark pesticide registration revocation issued in In Re Termilind, and was successful in forcing EPA to exercise its never before used authority under FIFRA to revoke as void ab initio a registration issued fraudulently to a B&C client's competitor.
 
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