Human Health Toxicology and Risk Assessment
Phronesis Scientific Consulting human health toxicology and risk assessment practice consists of well-credentialed, highly qualified, and respected practitioners who are focused on providing insightful, data-driven solutions to complex human health problems resulting from exposure to:
- Industrial chemicals
- Pharmaceuticals
- Medical devices
- Food and feed additives or contaminants
- Radioactive materials
- Consumer products
Our senior scientists have the requisite expertise to critically evaluate the available toxicological information that exists on chemicals, such as dose-response relationships, mode of action, and toxicokinetic, regulatory, and clinical toxicology data. Our senior staff excel at combining basic toxicological information with specific exposure or dose data to provide comprehensive toxicological evaluations, risk assessments, and actionable intelligence to decision makers. Our senior toxicologists and risk assessors are also skillful and articulate communicators, and can effectively present technical scientific information to non-expert audiences.
Our recent experience in the area of human health toxicology and risk assessment includes:
- Preparation of a comprehensive white paper that reviewed, critiqued, and summarized the available literature evaluating the safety of seafood for human consumption following oil spills that was used by decision makers assessing the human health impact of an oil spill off the coast of Brazil.
- Evaluation of selected industrial hygiene data collected during the Deepwater Horizon oil incident in the Gulf of Mexico to demonstrate the ability of a commercial software platform to accurately and completely characterize response workers’ exposures to chemicals and the potential associated health risks.
- Providing toxicological consulting services to two flavoring manufacturers concerning respiratory disease associated with exposure to diacetyl and other flavorings in microwave popcorn and flavorings workers.
- Performing a human health risk and safety assessment on the components of a manufacture’s proprietary artificial blood clot kit.
- Assessing the human health impact and risk of toxicity resulting from potential exposure to various mycotoxins detected in some samples of a manufacturer’s farm-animal feed.
- Reviewing, assessing, evaluating, and interpreting the results of air and wipe samples collected from several floors of a building whose occupants were concerned that offices were contaminated with lead, asbestos, fiberglass, fungi, mycotoxins and solvents. Assisted in the development of a sampling plan designed to thoroughly evaluate lingering concerns of chemical and microbial contamination.
Product Stewardship, Registration, and Safety Evaluation
Phronesis Scientific Consulting product stewardship, registration, and safety evaluation practice is led by a senior toxicologist with decades of successful industrial experience. Our senior scientists have worked extensively with the petro/chemical, chemical, and personal care product industries, as well as with the USEPA (FIFRA and TSCA) and FDA (direct/indirect food contact and OTC monographs), and have prepared dossiers for the support of the Biocidal Product Directive, REACh, and USEPA FIFRA registrations.
Phronesis Scientific Consulting product stewardship, registration, and safety evaluation scientists have:
- Extensively interacted with global regulatory authorities regarding testing strategies and quantitative structural assessment relationships leading to waivers or reduction in testing requirements.
- Conducted cancer and non-cancer human health risk assessments that have been accepted by various global regulatory authorities.
- Conducted cradle-to-grave environmental and ecological assessments to support chemical registration under the Biocidal Product Directive.
- Designed and implemented acute and subchronic toxicity tests including oral (dietary and drinking water), dermal and inhalation toxicity studies following OECD and OPPTS guidelines.
- Designed and implemented developmental, teratology, and perinatal toxicity tests as well as one- and two-generation reproductive studies.
- Designed and executed acute and subchronic neurotoxicity studies, developmental neurotoxicity studies, and intravenous, oral, dermal and inhalation ADME studies.
- Developed testing strategies to meet the ever-changing rigorous requirement of the global community for the global registration of antifouling and aquaculture biocides, including acute and chronic fish and invertebrate testing as well as bioaccumulation and fish residue studies.
- Conducted ecological risk assessment for active ingredients and their degradation products.
- Monitored and ensured compliance with appropriate regulations and guidelines.
- Oversee and troubleshoot analytical methods for measurement of active ingredients and their degradation products in the water column and fish tissue.
Pre-Clinical/Clinical Testing
Phronesis Scientific Consulting senior practitioners can effectively design protocols, initiate, monitor, and report GLP preclinical studies. We can assist in locating and placing studies with reliable scientifically competent laboratories anywhere in the world.
Much of our experience has focused on monitoring preclinical animal studies, including general toxicity (acute and repeated dosing), carcinogenicity, reproductive, teratology, and in vitro and in vivo genetic studies. We also audit and review studies, as well as prepare executive summaries for mammalian and aquatic toxicology and E-Fate investigations.
Our expertise in this area includes:
- Environmental chemistry
- Environmental fate and effect
- Oversight and monitor testing programs
- In vitro and in vivo genetic toxicology studies
- Mammalian and aquatic studies
- Auditing and review for regulatory compliance