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Biopesticide and Conventional Pesticide Registrations and Food Use Authorizations
- U.S. EPA and PMRA import tolerance petitions for new active ingredients
- Pre-submission detailed study-by-study review against the U.S. EPA guidelines for a high profile, multi-agency joint review submission for a conventional new active ingredient for food use to proactively identify report omissions to be addressed before submission via report supplements based upon the original raw data
- U.S. EPA registration of new animal health use formulations and label expansions
- U.S. EPA registration maintenance, including label and product chemistry amendments and responses to data call-ins
- U.S. EPA biopesticide tolerance exemption expansion to include all crops and label expansion to include a large number of new food uses
- Canadian (PMRA) registration of a new non-conventional pesticide and associated Canadian MRL evaluation
- Registration of multiple new biopesticide active ingredients for residential non-food use
- U.S. EPA/Canada/California shared review for a new conventional reduced risk active ingredient for outdoor and greenhouse food use and for nonfood use
FIFRA Training and Coaching
- Multiple custom designed FIFRA training courses for a large client for which the target audiences for the different courses were registration specialists, labeling staff, and regulatory department administrative staff
- Custom designed FIFRA training courses for small and mid-sized companies for which the target audiences included the regulatory, research, sales, marketing, customer service, and production department staff
- FIFRA coaching for a small company with a one-person pesticide regulatory department to address a variety of requests raised by the business requiring “outside of the box” regulatory strategies
Other
- Proposals to obtain EPA confirmation that biostimulants and pesticide devices are not regulated under FIFRA.
- National Organic Program (NOP) petitions to add to the list of a synthetic substance allowed in organic production (7 CFR §205.600)
- National Pesticide Information Retrieval System (NPIRS) database searches for pesticide registration information to inform pesticide registration strategies and business decisions for pesticide registrant companies
- Expert witness testimony regarding pesticide regulatory matters including data compensation and U.S. EPA policies
- Guidance regarding regulatory considerations associated with the purchase of U.S. EPA pesticide product registrations