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PRACTICES |
Hazard, Exposure, and Risk AssessmentOverview: The identification of potential chemical hazards and the extent to which they may or may not pose commercial challenges for a product is critical in determining whether the product will be viable in the marketplace. It is also critical for the product manufacturer to place the product on the market as quickly and cost effectively as possible while maneuvering through increasingly stringent regulatory schemes and a demanding public. Some regulatory schemes place the burden of hazard, exposure, and risk assessments on the registrant; in other cases, governments perform these assessments. Preemptive assessments are now more routine and performed prior to developing further a substance or product for the marketplace. It is important to understand and evaluate a substance within the regulatory framework applicable to its anticipated uses in commerce. The Acta Group (Acta®) has the technical resources and the regulatory know-how to help companies assess substances/product hazards, exposures, and risks. Our experts can help manufacturers/processors develop risk assessments that factor in a substance’s/product’s intrinsic human health, ecotoxicological, environmental fate, and physical chemical properties, and its uses and function. We also have the legal and regulatory background to help facilitate a smooth transition from research and development to entrance of the substance/product into markets across the globe. Our Experience: Acta professionals are scientists and business and regulatory consultants. This combination -- and their wealth of experience in and out of laboratories, as well as government agencies -- makes Acta an exceptional resource for companies in the chemical space. Our global presence, with offices in North America, Europe, and Asia, makes Acta an invaluable resource for companies that operate across countries. Jane Vergnes, Ph.D, DABT.®, based in the United States, has extensive global experience in chemical regulation and risk and exposure assessment, having led global product stewardship efforts for several Fortune 500-listed companies. She has managed toxicology, hazard communication, and regulatory affairs programs for a wide array of industrial and specialty chemical products, including personal care ingredients, household and industrial ingredients, biocides, performance chemicals, acetylenics, food and beverages, tablet coating systems, encapsulation technologies, and elastomers. Jason Johnston, M.S., has 30 years of experience in the areas of human health exposure and risk assessment. An expert in the development of strategies for exposure mitigation, Mr. Johnston has served as the project manager or senior scientist on a diverse range of occupational, residential, dietary, and anti-microbial exposure and risk assessments on behalf of U.S., North American, and European clients. His experience includes assessments prepared under specific legislative requirements, including the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Health Canada’s Pest Control Products Act (PCPA), and California’s Proposition 65. Oscar Hernandez, Ph.D., is an exceptional resource for clients addressing chemical assessment and management issues under federal, state, and international chemical control authorities. Dr. Hernandez is the former Director of the Risk Assessment Division (RAD) in the U.S. Environmental Protection Agency's (EPA) Office of Pollution Prevention and Toxics (OPPT), where he managed a multi-disciplinary science group that provided expert scientific support in the areas of hazard and risk assessment of chemicals being reviewed pursuant to the regulatory programs OPPT implements. Lara Hall, M.S. RQAP-GLP, offers clients over a decade of experience with scientific monitoring and quality assurance through all phases of data development, fate modeling, and environmental risk assessment to support new and existing product registrations worldwide. Scott Burya, Ph.D., a Regulatory Chemist with a Ph.D. in analytical chemistry, managed compliance, and notification activities for a multinational coating manufacturer. Dr. Burya is adept at performing quantitative exposure-based risk assessments for chemicals of concern, including substances on California’s Proposition 65 list and the European Chemicals Agency’s (ECHA) Substances of Very High Concern (SVHC) list. Our Asian team, managed by Brian Xu, M.D., Ph.D., DABT®, provides on-the-ground support for clients expanding their markets to China. Dr. Xu is a board-certified toxicologist, fluent in English and Mandarin, who has significant experience with U.S. Food and Drug Administration (FDA) and EPA regulations and the Orders and Decrees of the Chinese regulatory system. Dr. Xu designs safety testing, risk assessment, and product safety programs that enable clients to market their products quickly and efficiently. He and his team in China provide timely, accurate, and business-sensitive regulatory assessment support services globally. What We Do:
Representative Engagements:
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