Regulatory Consultants in the USA

Bernalyn McGaughey
President / CEO

In addition to providing corporate oversight for CSI’s various regulatory and scientific teams, Bernalyn’s extensive industry background can be drawn upon to address key project issues across the company. Bernalyn has over 40 years of data evaluation, chemical research, study monitoring, and project management experience in the properties, use, toxicology, and environmental fate of pesticides and other chemicals. Her activities have included original and regulatory research, report design and composition, and international technical assistance on toxicology investigations and risk assessments. She is a recognized scientific expert witness, industry task force manager, and strategist on pesticide risk and issue analysis.  She has done extensive work in endangered species assessment and issue analysis with respect to the intersection of the Endangered Species Act and other statutes.

Prior to founding CSI in 1988, Bernalyn held various regulatory and technical positions with Pennwalt and Shell Chemical Corporation’s agricultural chemical divisions. She has extensive pesticide regulatory and industry knowledge. She currently administers the FIFRA Endangered Species Task Force of agrochemical producers.

Cliff Habig, Ph.D.
Principal Consultant / Ecotoxicology and Environmental Fate

Cliff provides senior consulting expertise for ecological risk assessments, endangered species analyses, and endocrine disruptor (EDSP) evaluations. He has over 25 years of experience in ecotoxicology, environmental fate, and strategic support to U.S. and international clients for conventional crop protection products, biochemicals, microbials, biotechnology products, and HPV chemicals. Cliff’s background includes senior scientific consulting positions at Novigen and JSC. His career has focused on environmental toxicology, ecological risk assessment, higher-tier ecotoxicology evaluations, and probabilistic chemical fate and transport modeling and risk analysis, including assessments of potential effects on endangered species. Cliff has presented and published several environmental toxicology papers and has participated in numerous chemical industry workshops, expert panels and professional organizations with interests in ecological risk assessment.

Ashlea Rives Frank, M.S.
Principal Consultant / Endangered Species

Ashlea has over 13 years of experience navigating the complex interface between the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Endangered Species Act (ESA), focusing on data analysis, interpretation, and strategic support. Ashlea manages the Endangered Species Assessment team and has experience with a multitude of species, pesticide, and land cover datasets and how to apply them. She provides technical and regulatory planning and strategic support for endangered species matters and interacts effectively with multiple Agencies. Prior to joining CSI, Ashlea conducted insect behavior and control field studies, and has experience with sampling, insect rearing, GIS, and ecological observations. Ashlea received her B.A. from Southwestern University in Georgetown, Texas and her M.S. in Entomology from the University of Queensland, Australia where she studied the efficacy of Bacillus sphaericus for the control of one of Australia’s major arbovirus vectors, Culex annulirostris.

At CSI, Ashlea offers additional expertise in insect control, conventional and biopesticide registration, and pesticide risk assessment.

Larry Brewer, M.S.
Senior Science Fellow / Terrestrial Ecotoxicology

Larry has over 30 years of experience in avian, wildlife and pollinator ecotoxicology and ecological risk assessment. He is well known for designing and conducting avian, mammalian and pollinator terrestrial field ecotoxicology studies, including large-scale pollinator tunnel studies, honey and nectar residue studies and other non-target insect studies with chemical and biological products. Larry previously served 17 years as Director of Avian and Wildlife Toxicology at Smithers Viscient’s Carolina Research Center, North Carolina. Prior to that, he was President and Senior Scientist at Ecotoxicology and Biosystems Associates, in charge of domestic and international wildlife ecotoxicology field research, regulatory studies and risk assessment. Larry received his master’s degree in Wildlife Science from the University of Washington and his Bachelor’s in Fish and Wildlife Biology, minoring in botany, from Iowa State University of Science and Technology.

Larry has held positions as a Faculty member, Dept. of Environmental Toxicology at the Institute of Wildlife and Environmental Toxicology, Clemson University, where he was also leader of the Wildlife Toxicology Section of the Institute of Wildlife and Environmental Toxicology. He also served as Field Research Leader, Institute of Wildlife Toxicology, at Western Washington University. He spent over a decade as a Wildlife Research Biologist, at the Washington State Dept. of Wildlife. He has teaching experience in the areas of wildlife toxicology, ecotoxicology field techniques, and population ecology. Larry has authored numerous published papers and book chapters on topics of wildlife and environmental toxicology.

Leah Duzy, Ph.D.
Principal Consultant / Agricultural Economist

Leah has over 15 years of experience with USDA in applying economic principles to a variety of agricultural topics in both the Federal conservation program and agricultural research arenas. Leah received her Ph.D. in Agricultural Economics from Auburn University. She received a B.A. in Economics from the University of the South and a M.S. in Agricultural Economics from Purdue University. She has conducted applied economic research on a variety of topics including conservation production systems, cover crops, and herbicide-resistant weed management. She has experience with canola, cotton, corn, peanuts, soybeans, and wheat, as well as a number of fruit and vegetable crops. She has prepared cost-benefit analyses for Federal conservation programs as part of the rulemaking process, and has over 6 years of experience with conservation program management. She has published work in scientific journals and popular press magazines, as well as several book chapters, and has presented at numerous producer meetings and scientific conferences. She has a close working relationship with agricultural research scientists at Universities across the US and within USDA. She is also involved in her family’s row crop farm in Georgia, so is very much in contact with grower needs and challenges.

At CSI, Leah works on applying economic principles to risk and conservation decision-making for clients in need of applied research and economic impact analysis primarily related to product, agricultural and environmental development, assessment, and defense.

Melinda Bowman, B.S.
Principal Consultant / Regulatory Affairs

Melinda has 15 years of experience in product registration and regulatory affairs compliance for agricultural chemicals, biopesticides, and consumer products. She has worked on new pesticide active ingredient registrations, product registrations, and registration maintenance, including registration review responses, in the United States (EPA/FIFRA), Canada (PMRA) and internationally. Her experience includes various aspects of domestic and global registration dossiers, including state registrations and applications to set new import tolerances, international maximum residue limits, including new product label and claims development. Prior to joining CSI, Melinda previously held Regulatory Affairs and Registration Manager positions with companies such as TSG, Arysta LifeScience, FMC, Valent USA Corporation, and The Clorox Company. Her background in chemistry and mathematics add support to her years of expertise in assisting companies with strategic regulatory planning and compliance. Melinda is active within industry trade associations such as the Western Plant Health Association (WPHA), acting as the Chair and Task Force Lead of the Regulatory Affairs Committee (RAC).

At CSI, Melinda is a part of the US Regulatory Affairs team and manages various registration and compliance projects.

Jennifer Stafford, M.S.
Principal Consultant / Terrestrial Ecotoxicology

Jennifer joined CSI after 15 years as a Senior Biologist, Study Director and Laboratory Manager for Smithers Viscient’s Avian and Wildlife Toxicology Department. Jennifer’s expertise includes conduct and management of avian and GMO regulatory studies, under Good Laboratory Practices Guidelines (GLP), with focus on ducks, quail, passerine species, chickens and catfish. She has in-depth experience in avian and catfish nutritional requirements and diet preparations. Her past duties required protocol development, study conduct, data analysis, and project reporting to meet EPA, OECD, and other regulatory guideline requirements. Prior to her employment with Smithers Viscient, Jennifer worked as a field biologist for Ecotoxicology and Biosystem Associates where she participated in large-scale, tier 3, GLP wildlife toxicology field studies. Thereafter, she then worked for the Confederated Tribes of Warm Springs, John Day, Oregon, on their salmon habitat restoration program, focusing on grant applications, National Marine Fisheries Service consultations, and water quality monitoring. Jennifer earned her Master of Science Degree at Utah State University where her research focused on avian exposure to pesticides through consumption of dead insects following pesticide application.

In her capacity at CSI, Jennifer will be serving clients in avian risk assessment, study management and related areas.

Rick Kemman, M.S.
Senior Consultant / Environmental Scientist

Rick is an environmental toxicologist, with over 15 years experience in pesticide ecotoxicology assessments. He has participated in large-scale research projects assessing the impacts of pesticides on free-ranging wildlife populations in both agricultural and urban environments. Rick has conducted various field investigations, collected environmental samples, and interpreted biological data. His experience includes environmental site characterizations, radio-telemetry projects, and laboratory research including residue analysis, bioassays, and wildlife dosing studies. He provides a regulatory perspective to risk assessment projects conducted by CSI’s risk assessment team.

Jeff Wirtz, M.S.
Senior Consultant / Ecotoxicologist

Jeff has over 15 years of experience in environmental toxicology and ecological risk assessment. His experience includes sample collection, data analysis, interpretation, and quality evaluation. In addition to his scientific background, Jeff has served as a Quality Assurance Officer, with specialties in EPA, FDA, and OECD Good Laboratory Practice (GLP) standards and their application. He has prepared risk assessments and ecological reports for a variety of U.S. and international clients examining terrestrial and aquatic effects for product and site assessments. Jeff has performed research into various ecological issues including large data searches for information regarding metal and pesticide ecotoxicity. He has published such work in scientific journals, as well as scientific conference presentation. His project background includes preparation of substance dossiers to meet U.S. and European requirements.

David Campana, M.S.
Senior Consultant / Spatial Analyst

David has experience in ecological risk assessment and agronomy under US and EU regulatory frameworks. His background includes GIS analysis and database management, aquatic and terrestrial pesticide exposure modeling, toxicological effects analysis, bioassay management, laboratory data evaluations, and technical report writing for risk assessments subject to FIFRA and ESA legislation. In addition to his scientific background, David has supported the development and implementation of projects for agricultural sector clients, primarily involving cost-benefit analysis and market access. He has also edited technical reports written for industry trade associations, US government agencies, and commercial firms. His project background includes species range mapping; hydrologic, chemical transport, and spray drift modeling; statistical analysis; efficacy study review; database management; and engaging in project development.

In his capacity at CSI, David contributes to regulatory and scientific projects for CSI clients, especially ecological and human health risk assessment of pesticides. David is a member of the SETAC finance committee.

Jeremy Wilson, B.S.
Business Development / Regulatory Consultant

Jeremy has over 20 years of experience in regulatory affairs and product registration compliance with Federal, State, and International chemical regulations. His experience includes government agency interactions and determination of appropriate regulatory pathways to meet product registration objectives. He has prepared numerous registration submissions, placed and monitored necessary GLP studies to develop data and documentation, and served as the primary agency liaison for the registration process. Jeremy has particular expertise with biorational/biopesticide registration and Latin America regulatory requirements.

In his capacity at CSI, Jeremy works in our regulatory team to secure and maintain client product registrations. He also leads CSI’s marketing and business development efforts in the USA and represents CSI at various industry trade associations and professional societies.

Chad Jones, B.S.
GIS Analyst

Chad specializes in Geographic Information Systems (GIS) and geospatial analysis. Chad has a B.S. degree in Environmental & Ecosystem Sciences, and a minor in spatial analysis from Washington State University, as well as a B.S. degree in Business Administration (Finance) from University of Louisville, Louisville, KY. Chad has experience in watershed management, limnology aquatic ecology management, forest plants and ecosystems, GIS spatial analysis, remote sensing and aerial photo interpretation, wildlife habitat ecology, landscape ecology, and natural resource policy and law. Chad supports CSI’s team of ecological risk assessors on various applications of spatial technology for client projects.

Jeff Giddings, Ph.D.
Senior Science Fellow / Ecological Risk Assessment

Jeff is a part of CSI’s ecological risk assessment program. He has over 30 years of research, testing, and consulting in environmental toxicology and ecological risk assessment in North America and Europe. He is a recognized risk assessor who has provided senior support to domestic and international clients for the development, analysis and interpretation of environmental data. Jeff’s background includes senior positions at the Oak Ridge National Laboratory, contract research organizations and consultant groups. He has provided oversight of experimental ecosystems (mesocosms and microcosms) and laboratory ecotoxicology studies with fish, algae, aquatic invertebrates, terrestrial plants, soil invertebrates, and insects. Jeff has extensive publications and presentations in the field of environmental toxicology. Since 1994, Jeff has specialized in ecological risk assessment and endangered species analysis of pesticides.

Bruce Riggle, Ph.D.
Regulatory and Technical Consultant

Bruce joined CSI after having spent 30 years in the chemical/pesticide industry as an expert in registrations, product development, project management, and Good Laboratory Practices. Bruce has experience in handling both new active ingredients and tolerance expansions for both standard and biopesticide chemistries as well as genetically modified organisms. He has developed new active ingredients that involved company patents. Bruce has also been an expert witness in spray drift related cases. His chemistry background includes developing methods and conducting and monitoring radiochemical studies. The majority of Bruce’s work has involved biopesticides, herbicides, bactericides, fungicides, rodenticides, and insecticides. He has served as a company technical expert for an industry task force and was also a company field radiation safety officer. Bruce has also been responsible for field terrestrial, animal feeding, and magnitude of the residue studies.

At CSI, Bruce brings a greater depth to our product registration, product development, and environmental fate expertise.

Ron Kobylnyk, Ph.D.
Canadian Regulatory Consultant

Ron W. Kobylnyk has worked for federal and provincial governments as well as small companies for over 35 years and brings a wealth of related experience to any project. Ron’s experience offers pesticide-related consulting service to governments and smaller companies requiring professional service on regulatory and scientific affairs. As a regulatory consultant, Ron has expanded efforts into fertilizers, pharmaceuticals, and other substances. Ron has obtained product registrations/approvals under the Pest Control Products Act, the Fertilizers Act, the Food and Drugs Act, and the New Substances Notification Regulations in Canada. Throughout his career he has developed policies, regulations, teaching materials, databases, and carried out other critical regulatory analyses.

Maya Ramsey, M.P.H.
Associate Consultant / Regulatory Affairs

Maya has more than 5 years of experience working in regulatory affairs compliance with agricultural chemicals. Starting with State registration renewals, she quickly gained knowledge and expertise that helped play a vital role in guaranteeing new active ingredient registrations in a timely manner at the State level. She coordinated and participated in various state agency meetings to both defend product registration status and develop a proactive plan to ensure all data is available to support pesticide product registration.  Maya also has experience managing pesticide active ingredient registrations at the Federal level with USEPA under FIFRA.  While managing pesticide active ingredients, she gained experience in things such as label compliance review, new uses, new formulations, establishing tolerances, registration review, and new source submissions to USEPA. During her time in industry she has been very active in industry trade associations and served as past Co-Chair of the Regulatory Affairs Committee (RAC) for the Western Plant Health Association (WPHA).

At CSI, Maya is a part of the US Regulatory Affairs team and works on various registration and compliance projects.

Katherine Carr, M.S.
Consulting Ecotoxicology & Exposure Modeling Scientist

Katherine Carr spent over 33 years in the chemical industry, working primarily in support of global registration issues for pesticides, and holds degrees in chemistry and computer science. She is proficient in exposure assessment modeling (environmental water, drinking water, soil, sediment), ecological risk assessment, and endangered species assessments to support global pesticide registration and stewardship issues in the U.S., Canada, and Europe. Kathy is experienced in the use of computer modeling tools used for pesticide regulatory analyses, including those used for degradation kinetics. She also has expertise in spatial analysis (using ArcGIS software), environmental data analysis and management, dossier preparation for European registration, and technical report preparation. Her experience includes the conduct and monitoring of environmental fate, metabolism, and ecotoxicology studies under GLP. In her industry positions, Kathy contributed for many years to industry work groups regarding exposure modeling and endangered species issues.