Specializes in providing FIFRA regulatory support for new active ingredients, registered active ingredients, food-use and non-food use pesticide products, new end-use products, new uses of registered products, and supplemental/distributor registrations.
Managed international registration efforts for pesticide products in Canada, Mexico, Europe, Central America, South America, Australia, and Asia.
Managed the data development for multiple active ingredients and end-use products in support of federal and state pesticide registration, EPA registration review, EPA re-registration, special reviews, and other data requirements under FIFRA. This work included general regulatory consulting services, coordination of client and laboratory interactions, and managing and monitoring ongoing health and safety studies at contract laboratories. His experience also includes interpretation of the data results and how the results effect the overall registration process.
Managed multiple industry task forces. He was the administrative manager for an industry task force focused on the reinstatement of tolerance exemptions for inert (other) ingredients. This work involved developing a strategic plan for each group of inert ingredients, implementing the strategy, placing and monitoring toxicology data, preparing and submitting petitions for tolerance exemption, and tracking EPA submissions to approval.
Expert in obtaining new inert (other) ingredient approvals for food-use and non-food use through EPA's Chemistry, Inerts, and Toxicology Assessment Branch. This work involved developing an EPA regulatory strategy, outlining appropriate data requirements, implementing the strategy, and preparing and submitting petitions for the new inert ingredient (including tolerance exemption petitions for food-use products).
Supported new chemical products under the Toxic Substance Control Act (TSCA), including preparing and submitting Pre-Manufacture Notices (PMNs), Low Volume Exemptions (LVEs), Polymer Exemptions, Significant New Use Notices (SNUNs), Significant New Use Rules (SNURs), Notices of Commencement of Manufacture (NOCs), Risk Assessments, and Chemical Import Issues.
Experienced in evaluating data compensation, study valuations, and cost reconstruction in support of clients' negotiations in data compensation matters.
Advised clients on regulatory and technical matters related to child-resistant packaging and required testing.
Managed reduced risk EPA petitions in support of expedited review of applications for registration for food and non-food uses. Developed the strategy and rationale to support the submission.
Performed due diligence reviews of pesticide products and supporting data for potential acquisition.
Performed EPA FIFRA training for clients.
Provided regulatory and technical support for Global Review and NAFTA submissions for new active ingredients.
Prepared multiple tolerance exemption petitions for polymers (qualifying for polymer exemption), including submission of all supporting data and tracking of the EPA review and approval of the new food-use polymer inert ingredient and associated tolerance exemption.
Prepared and submitted multiple new non-food use inert (other) ingredient petitions to EPA.
Provided data compensation negotiation support for registration of pesticide product under FIFRA. Performed evaluation and valuation of data. Directed data compensation negotiations between companies.