Ms. Daniels has over 10 years of experience with EPA FIFRA regulatory issues such as new active ingredient and new product registrations, reduced risk petitions, registration review, import tolerance petitions, regulatory strategy, and general registration support including label amendments and notifications. She has regulatory expertise working with conventional chemicals, biopesticides, and antimicrobials at the Federal and State levels. Ms. Daniels works with other senior staff members and clients to develop appropriate regulatory strategies, including data development plans, based on the needs of each client and the regulatory requirements for each product. She is adept at bridging the intersection of technical issues with the regulatory requirements.
Ms. Daniels conducts and coordinates due diligence and registrability evaluations for individual products, specific product-lines, and complete portfolios. She is skilled in the review and research of the current and historical regulatory status of product registrations. Ms. Daniels has a strong research background in U.S. and international pesticide and food regulations, and is experienced in understanding the connections between these regulations. She has extensive experience researching pesticide and food related regulatory issues using a variety of resources and databases including NPIRS, EPA and FDA dockets, the Federal Register, NLM, and various EPA databases.
In addition, Ms. Daniels works with senior environmental toxicologists conducting and coordinating tier one environmental modeling programs such as LEACHP, GENEEC, SCI-GROW, and FIRST. Ms. Daniels also uses the results from environmental modeling to calculate risk quotients and derive comparisons between pesticide chemicals.
CREDENTIALS & PROFESSIONAL HONORS
- M.A., International Development Studies, George Washington University, 1997
- B.A., International Relations, Roanoke College, 1995
Barraj L, Scrafford C, Lantz J, Daniels C, Mihlan G. Within-day drinking water consumption patterns: Results from a drinking water consumption survey. Journal of Exposure Science and Environmental Epidemiology 2008; Epub available at: http://www.nature.com/jes/journal/vaop/ncurrent/abs/jes200828a.html.
Messina JB, Daniels CL, Polakoff BM, Tucker KD. Registration? But it’s a natural product. Presentation at the American Chemical Society National Meeting, New York, NY, September 9, 2003.
Johnston JE, Scrafford CG, Daniels CL. An examination of exposure database limitations. Presented at the 2002 International Society of Exposure Analysis/International Society for Environmental Epidemiology Annual Conference, Vancouver, British Columbia, Canada, 2002.
Prepared and led one-day seminars on EPA FIFRA and TSCA topics of interest, tailored to client portfolios and strategic needs.
Led multiple due diligence evaluations both for specific compounds as well as complete company portfolios. The evaluations included leading multi-disciplinary regulatory and technical teams in the review of the regulatory status and the toxicological, ecotoxicological, and environmental fate profile of a compound or portfolio of compounds.
Participated in the management and preparation of several successful Reduced Risk and Organophosphate Alternative submissions to the EPA. Responsibilities included running environmental fate models such as GENEEC, SCI-GROW, and FIRST, researching and compiling toxicology, ecotoxicology, and environmental fate data on competitive products, and coordinating the compilation of the submission with the client as well as internally.
Worked closely with technical staff in the preparation and refinement of LEACHP modeling in support of New York state pesticide registrations.
Prepared multiple import tolerance submissions for the US and Canada.
Assisted with the review and development of the registration strategy for several novel antimicrobial products. These projects included assisting with the review of protocols and set up of studies, coordinating with the analytical laboratory, and managing submissions to the EPA.
Assisted in the execution of a multi-year GLP market basket surveys. Coordinated with survey participants and laboratories to ensure arrival of samples. Assisted with the management of raw data in accordance with GLP procedures.
Conducted extensive literature searches and research (including compilation, and organization of materials) in support EPA and FDA submissions. Conducted research into food and pesticide regulations in Latin America, the EU, and Japan to support client registration needs.
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