The Sapphire Group assists clients in the design and implementation of customized human health risk assessment. We guarantee to use the most appropriate and innovative assessment of risk, working both prospectively and retrospectively, in whatever the client situation. Conducted by experts on our staff and respected leaders in the field, our approach involves a four-step process, including hazard identification, toxic potency analysis, exposure assessment, and risk characterization. Used by corporations and government, this approach follows that articulated by the National Academy of Science.
Hazard Evaluation
The Sapphire Group, a leader in health sciences, helps its clients understand whether a causal relationship rises between exposure to a chemical and injury to human health. We gather and analyze a variety of toxicity data on the types of human injury or disease produced by exposure to a chemical, including how that chemical acts within the body.
Our analyses assists our client in understanding qualitatively whether a toxic effect shown by their chemical in one situation is relevant to another situation. For example, if a chemical is found to be carcinogenic at high doses in experimental animals, what, if any, relevance does this have to humans? The Sapphire group will draw conclusions as to the meanings of the effects produced in animals as they provide limited reliability in predicting the results in humans. This step is critical prior to the toxic potency assessment phase, which examines at what levels a substance is toxic to humans.
Exposure Assessment
At this step in the risk assessment process, The Sapphire Group determines the nature and size of the various populations exposed to a chemical. We look at the magnitude and duration of that exposure. Our assessment includes current and future exposures, age and gender of those exposed as well as conditions such as pregnancy, children, age and preexisting illness, and lifestyle.
Toxic Potency Assessment
A highly complex process, this step is used to quantify the relationship of the exposure to a chemical and the extent of injury or disease. Based on animal studies and possibly some human studies, the assessment shows the numerical range of dose-response relationships taking into account metabolism and kinetics as well as amount and duration of exposure. For example, the results include such critical factors as single versus repeated exposure and prolonged exposure; type of response – cancer and birth defects; the body’s ability to manage the exposure and the differences between rodents and humans. The Sapphire Group employs specialized procedures such as PBPK modeling during this step to ensure the data are scientifically defensible.
Risk Characterization
We provide estimations of the risk for individuals and specific population groups and the likelihood they will experience any health-related injuries under known or anticipated rates of exposure. Our risk assessment process provides our clients with a complete integration of the data and analyses from the previous three steps, taking full account of the uncertainties associated with the conclusions, and provides a well-constructed assessment strongly supported by agreed upon scientific understanding.
