Environmental Protection Agency
Lewis & Harrison consultants provide high quality advice to companies that produce and market products regulated under FIFRA and TSCA.
Specifically, we help manufacturers, formulators, distributors and importers navigate the complex process of preparing, registering and evaluating their products.
• Registration applications, labeling and formula amendments for new antimicrobial, conventional pesticide and biopesticide products
• Registration applications for new active ingredients and new uses of existing active ingredients
• Dossiers for new inert ingredients
• Tolerance or tolerance exemption petitions for food use active ingredients and inert ingredients
• Pre-Manufacturing Notifications (PMNs), Test-Marketing Exemptions (TMEs) and Low-Volume Exemptions (LVEs) for new chemicals
• Registration and reporting for domestic and foreign pesticide product and device producing establishments
• Data compensation values and liabilities for data owners and me-too registrants
• Competitor products and providing early intelligence on competitor activities
• Contracting and monitoring safety and efficacy studies for registration actions and Data Call-Ins (DCIs)
• Responding to DCIs and managing Task Forces to develop DCI required studies
• Conducting compliance audits and developing compliance programs for pesticide and general chemical products
• Provide expert advice on recordkeeping and reporting responsibilities, suitable label and advertising claims