My First STEPs into the World of Risk Assessment

By Michael Kerins posted 10-11-2018 13:14


In September, I had the opportunity to attend a week-long intensive Dose-Response Boot Camp in Cincinnati, OH. This course, hosted by Toxicology Excellence for Risk Assessment (TERA), provided fundamental groundwork in the field of toxicology risk assessment. The workshop consisted of instructor-led seminars on concepts in dose-response and risk assessment, as well as hands-on exercises and mock “full” risk assessments with known chemicals. The course was designed pedagogically, providing fundamentals on risk assessment theory and mode-of-action development before moving into the more challenging and quantitative aspects of study evaluation, dose-response assessment, and formal reporting.

The coursework was led by renowned experts in the field of risk assessment, including Dr. Michael Dourson, board-certified toxicologist and TERA Director of Science, and Dr. Bernard Gadagbui, board-certified toxicologist. With decades of risk assessment experience between the two of them, Drs. Dourson and Gadagbui provided unique, experiential insights into the training. They also tapped into their broad network of established experts, such as Melissa Vincent of Cardno ChemRisk and Dr. Lynne Haber from the University of Cincinnati. All instructors were friendly, helpful, and beyond knowledgeable about risk assessment.

The boot camp started with an overview of risk assessment, which set the framework for hazard assessment and characterization and dose-response assessment. I learned how to identify whether a database is sufficient to move forward with an assessment and identify the critical effect of a chemical. We looked at how to identify a mode-of-action for a chemical and interpret toxicological data and endpoints in the context of toxicological science. We then moved into dose-response assessment, which is a complicated topic requiring an understanding of the mode-of-action of the chemical. We discussed the idea of uncertainty, and how we can use No Observed/Lowest Observed Adverse Effect Levels or benchmark doses with uncertainty factors to engender a “safe dose” of a chemical. This involved quantitative assessment of dose-response and the mathematical modeling of dosimetry. This approach was coupled with practical exercises and software training. All of these rolled together in the context of risk characterization will eventually drive a policy decision.

My fellow trainees came from a variety of backgrounds and knowledge bases: we had a diverse group from government, academia, and industrial fields. Some, like myself, were early-career scientists or trainees while others had years of experience in a variety of roles. This dynamic provided a unique melting pot of perspectives that generated unique questions and insights during the training. I found the instructors catered well to the variety of backgrounds present, where I, as a graduate student with no formal risk assessment experience or training, felt as comfortable as some of my more experienced colleagues. They truly start you from the ground up!

While the lectures and class exercises provided the fundamentals, the true capstone experience arose from our case study risk assessment.  This consisted of a guided set of diverse and complicated scientific studies that our small group of four people had to wade through and utilize to perform a full risk assessment, based on real-world data, and identify a “safe” dose or lifetime risk factor. My group had many spirited debates on how to approach the problem; we were assessing the carcinogenicity of a dietary chemical that appeared to cause thyroid and mammary tumors. More so than the science or analytics, this case study provided an opportunity to debate the appropriate risk assessment path among well-trained and clever scientists. This is where the “art” of risk assessment comes into play and ended up being a fun exercise.  It culminated in a short, formal presentation of our group’s assessment to the wider class audience who critically evaluated, questioned, and critiqued our work.

My experience at TERA’s Dose-Response Boot Camp was outstanding. The knowledge I gained at the workshop will enable me to pursue my goal as a toxicologist by providing fundamental tools and thought processes for assessing the risk of compounds; this is not a common training area in graduate school, so I trust that the fundamentals I gained in this course will be applicable to wherever my toxicology career takes me.  I encourage all students to take advantage of a STEP award to broaden their knowledge in fields into which they may be interested in moving.

Note: The next deadline for STEP applications is May 1, 2019.