PRACTICES

Chemical Regulation under FIFRA

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.

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 scientific, business, and policy experience.

The professionals at The Acta Group (Acta®) know the process well, and know how to achieve competitive advantage for their clients. Acta 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 policy and commercial challenges.

Our Experience:

Acta professionals have substantial experience in the developing regulation and policy of products implicated under FIFRA.

Lynn Bergeson has assisted clients for over 30 years in resolving and advocating on often precedent-setting, novel, and complex pesticide regulatory issues. Ms. Bergeson is engaged in the evolving law and policy of nano pesticides.

Lisa 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, and other hot button FIFRA and Food Quality Protection Act (FQPA) issues.

Timothy Backstrom worked 25 years with the U.S. Environmental Protection Agency (EPA). During his tenure at EPA, Mr. Backstrom did extensive work under FIFRA and was involved in drafting many regulations and policies concerning pesticides, including procedures for pesticide reregistration and for public participation in the special review and reregistration process.

Lisa 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 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.

Jason Johnston, M.S., has more than 25 years of experience in the field of risk assessment and has served as the project manager/senior scientist for a diverse range of risk assessments required under FIFRA.

Sheryl Dolan works with registrants of agricultural and other conventional pesticides, antimicrobial products, biopesticides, and plant regulators to register and manage compliance with requirements under FIFRA.

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.

Lara Hall, M.S., a Scientist and Registered Quality Assurance Professional in Good Laboratory Practice (RQAP GLP), assists clients through various aspects of 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. Additionally, Ms. Hall assists in maintaining and updating extensive datasets for pesticides and antimicrobial products to support registration requirements.

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, Reregistration, and Registration Review –
    • Assist clients across registration, reregistration, and registration review issues, such as:
      • Pesticide Registration Improvement Extension Act (PRIA 3) 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 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:

  • Acta is among the elite in pesticide practice and policy firms representing global product manufacturers on virtually every aspect of FIFRA/FQPA policy, science, and regulation.
  • Acta assists both large and small product manufacturers and trade associations in tackling the daunting array of scientific, regulatory, and policy challenges confronting the agricultural chemical community. Acta 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.
  • 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 professionals have procured countless successes for clients in obtaining novel registrations, continuing challenged registrations, and/or diminishing the regulatory constraints on existing registered products.
 
THE ACTA GROUP, L.L.C.
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