Hazard, Exposure, and Risk Assessment

Overview:

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:

• Provide Hazard Data Appraisal and Literature Reviews
  • Toxicology
  • Environmental
  • Physical/chemical
  • Analytical method development and validation
• Manage Testing Programs, including:
  • Assessment of data requirements
  • Development of testing strategies
  • Study design
  • Protocol/study plan development
  • Laboratory inspection for Good Laboratory Practice (GLP) compliance, scientific capabilities, and humane animal welfare practices
  • Study placement, including contracting with contract research organizations (CRO) and invoice management
  • Review draft reports and data for scientific integrity, conformance with test guidelines, and GLP compliance

Representative Engagements:

• Acta professionals have been involved in countless negotiations with EPA and other agency scientists, and in those discussions have successfully demonstrated scientific positions that have resulted in agency decisions that are science-based and have provided significant commercial value. For example, these science-based decisions have allowed important products to stay robustly in the market despite initial agency efforts to remove or severely restrict them.
• Acta professionals have written and critiqued numerous risk assessments both in and outside the U.S.; work on these has often resulted in significant regulatory change for challenged products that has provided significant commercial value.
• Acta professionals have prepared individual, aggregate, and cumulative residential and consumer product exposure assessments using deterministic and Monte Carlo techniques and have managed and conducted numerous residential and occupational exposure assessments on behalf of clients to assess dermal, inhalation, and oral exposures to humans from pesticide products, such as fumigants; termiticides; flea and tick products for pets, carpets, and turf; fungicides for turf and home gardens; and indoor and outdoor insecticide fogger products.  Their residential and occupational exposure and risk assessments of chemical products enable clients to support their products within various regulatory communities at EPA, FDA, the California Department of Pesticide Regulation (CDPR), the European Commission (EC), the Australian Pesticides and Veterinary Medicines Authority (APVMA), and others.
• Acta professionals have obtained approval through the premanufacture notification (PMN) process for an important new product in the petroleum field with environmental benefits, including reducing the need for oil. The volume of production for the new substance was extremely high and a number of the components in it were extremely toxic, which resulted in very close scrutiny by EPA.  Concerns were addressed in a variety of ways, including use of the Sustainable Futures program to demonstrate low risk based on low exposure and release, and emphasis on pollution control and environmental benefits of the new technology.