Dana S. Lateulere
Dana S. Lateulere is a Regulatory Consultant with The Acta Group (Acta®). Ms. Lateulere draws upon her 30-plus years of pesticide regulation experience, including a decade with the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP), as she assists clients with federal and state pesticide registrations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Federal Food, Drug, and Cosmetic Act (FFDCA), and applicable state regulations. Ms. Lateulere’s experience and skill in preparing and submitting new product submissions and registration review responses, managing lab work and data procurement, composing compliant label systems, and shepherding submissions through regulatory agency review efficiently and timely are tremendous assets to clients.
- Provided technical expertise and project management support, including direct Agency interactions, in completing new pesticide registrations for a client.
- Provided technical expertise to a pesticide registrant through reviewing the existing EPA database in support of a technical product, developing strategies for data waiver requests, and preparing the submission for registration.
- Provided technical and regulatory expertise for successful presentation of human study protocols and final reports to EPA’s Human Studies Review Board.
- Assisted client in seeking an EPA proposal of rulemaking to restore an inadvertently removed exemption from the requirements of FIFRA.
- Assisted client in securing expedited EPA approval of a lower risk alternative to a recently canceled wood preservative.
- Guided a registrant developing a novel biochemical active ingredient to develop the data required and registration strategy to support a pesticide registration.
- Assisted a client in preparing and presenting to EPA a rationale to support the reclassification of the client’s product; the successful reclassification achieved significant time and cost savings for the client.
- Assisted a start-up company successfully to register several new antimicrobial products.
- Assisted a large, multinational company with preparing responses to generic and product-specific data call-ins.
- Guided a registrant developing a new antimicrobial product through EPA data requirements and assisted with laboratory placement and monitoring of studies.
- Provided technical knowledge and registration support for state registrations.
- Provided a small niche company with technical knowledge and registration support of FIFRA Section 25(b) Minimum Risk Pesticides.
- Assisted pesticide-producing companies with setting up new establishment sites and submitting initial reporting requirements.
- Assisted several disinfectant pesticide registrants in meeting the requirements applicable to a product with public health claims.
- Provided guidance to a cosmetic producer to recognize pesticidal claims under FIFRA to ensure its product’s compliance.
- Assisted a client with a potential acquisition by providing an audit of the target’s FIFRA product compliance.