Fumigants used for pesticidal purposes are registered and regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In 2009, the U.S. Environmental Protection Agency (EPA) completed a significant review of registered fumigant products as part of its reregistration program, pursuant to which EPA required expansive label changes and new study requirements for many fumigants. EPA has more recently initiated a Registration Review program for fumigants under which it has requested and will review additional new data. A number of state agencies also focus regulatory attention on fumigant practices, and fumigants are the subject of increasing interest from community and public interest groups, all of which adds to the challenges faced by fumigant product registrants and applicants for registration.
The regulatory and scientific professionals at The Acta Group (Acta®) have extensive knowledge of, and experience with, EPA's regulatory process, its registration requirements under FIFRA, the Food Quality Protection Act (FQPA), and Occupational Safety and Health Administration (OSHA) regulations, and state law requirements. Our professionals assist fumigant producers and users to navigate the increasing regulatory, policy, and scientific complexities and challenges in obtaining, maintaining, and stewarding their federal and state registrations.
In addition to Acta's work with individual clients, our affiliate B&C® Consortia Management, L.L.C. (BCCM) provides advocacy, testing, and public policy support for a number of fumigant industry groups aligned around common regulatory and product stewardship interests.
Acta professionals have significant and specialized expertise in product registration and regulation issues under U.S., Canadian, European, and Asian regulatory frameworks.
Lisa Campbell has over 20 years of experience assisting fumigant manufacturers in resolving registration, reregistration, and registration review issues under FIFRA and FQPA, as well as other statutes. Ms. Campbell has worked extensively with manufacturers and users to address significant and far reaching revisions to label requirements, application practices, stewardship, and other practices in response to various EPA and state initiatives. She has additionally assisted product manufacturers to negotiate, define, and satisfy testing requirements and to address complex regulatory questions and challenges. Ms. Campbell has also worked extensively with registrants in developing training and product stewardship programs. She has counseled many registrants in their individual and coalition responses to questions raised by EPA during the reregistration and registration review processes.
Lynn Bergeson has assisted registrants and commodity groups for years. Ms. Bergeson works with foreign and domestic fumigant registrants and users on a wide variety of policy and regulatory matters involving risk management, compliance, and product stewardship initiatives. Ms. Bergeson and others in the firm also assist registrants in transferring their registrations in the context of corporate acquisitions and related due diligence, and in assessing the benefits and potential risks associated with fumigant registrations.
Jim Aidala is a critical ally for clients addressing fumigant policy, legislative, and related issues. Mr. Aidala brings extensive legislative experience on Capitol Hill and past experience as the senior official at EPA for pesticide and chemical regulation, and provides clients with vital insights into not only relevant current policies of EPA and sister agencies, but also the way these policies have been or are likely to be formulated to help clients more successfully address regulatory matters regarding chemicals and pesticides.
Senior Scientist Susan Youngren, Ph.D., has more than 30 years of experience in the field of risk assessment. Dr. Youngren has worked with manufacturers to estimate potential buffer zones using the Probabilistic Exposure and Risk Model for FUMigants (PERFUM) used by EPA in the registration assessment of soil and commodity fumigants. Dr. Youngren has assisted clients in developing appropriate science-based responses to EPA testing requirements and has helped clients avoid unnecessary requirements by demonstrating the adequacy of existing data to address regulatory questions and endpoints. Dr. Youngren has evaluated the potential exposures and resulting buffer zones for a proposed new fumigant.
Regulatory Specialist Sheryl Dolan has worked extensively with fumigant manufacturers to obtain and maintain registrations, and to respond to Data Call-In requirements, reregistration, and registration review requirements. Ms. Dolan is also very experienced in state registration and registration renewal requirements.
For over a decade, Jake Vandevort, manager with BCCM, has helped clients develop and expand product stewardship and advocacy programs, and craft effective responses to federal and state actions. Mr. Vandevort works with fumigant manufacturers to manage the complex and often fast-paced administrative needs faced by industry when responding to regulatory requirements.
Acta also draws on the legal skills and expertise of our affiliated law firm, Bergeson & Campbell, P.C. (B&C®).
What We Do:
Acta professionals routinely advise fumigant clients on a full range of FIFRA, OSHA, and state issues, including registration, reregistration, and compliance. Our work with fumigant manufacturers and users includes the following:
- Regulatory advocacy, counseling, and related services focused on effectively addressing complex issues arising as a result of EPA and state assessments of fumigant registrations, uses, and reregistration/registration review or equivalent processes
- Data production requirements, and related data compensation issues and advocacy, relating to federal registration approval and registration review processes, as well as related state processes
- Development of training programs and outreach material
- PERFUM Modeling
- Risk Assessment
- Toxicology Review
- Study Placement
- Full Service Task Force Management -
- General administrative and organizational needs
- Accounting services
- Consensus building
- Records of meetings and conference calls
- Antitrust counsel
- Acta assists clients in navigating successfully challenging reregistration and registration review processes, including working with clients to achieve consensus with EPA in response to EPA's proposals for unprecedented new programs and studies and in response to extensive new labeling and communication requirements.
- Acta assists clients in addressing and using models for exposure and risk assessment that are necessary to allow continued product use, as well as to register new uses and new products.
- Acta assists clients in addressing and developing workable buffer zones.
- Acta assists clients in collecting and assessing existing exposure data.
- Acta assists clients in evaluating and strategically and effectively addressing the potential regulatory and safety ramifications of scientific assessments of their products.
- Acta assists clients in addressing and resolving issues related to EPA's authority to impose certain requirements, data compensation issues related to novel EPA requirements, and process issues at both the state and federal level.
- Acta works with clients to modify and develop study protocols, to address study requirements, and to manage issues that arise when studies are completed and submitted.
- Acta and our affiliate BCCM assist various groups of fumigant manufacturers organize and respond effectively to EPA and state challenges, and to manage and address user questions, concerns, and general stewardship issues.
- Acta and BCCM work with clients to develop training and other stewardship program initiatives.