Note: May 1 is the next deadline for graduate student applications for Supplemental Training for Education funding.
As a final year PhD candidate in a mechanistic toxicology laboratory with prior industrial experience in the core toxicology risk assessment area, my career goal is to become a competent overall Toxicology Risk Assessor (Drugs + Cosmetic/Chemicals + Medical Devices + Food Products). Before beginning my PhD study in the Department of Toxicology at the University of Louisiana at Monroe (ULM) in August 2012, I worked for Johnson & Johnson Limited (J&J) in Mumbai, India, for 3 years as a toxicology risk assessor. At J&J, I was responsible for the risk assessment of several categories of consumer and personal care products to be launched in North America. Since then, I have always kept myself updated on this fascinating area through the Society of Toxicology (SOT) CEd-Tox courses and contemporary literature.
While CEd-Tox offers some excellent courses to learn about the basics of toxicology risk assessment, including for medical devices, an exclusive course on the safety assessment of food products has yet to be offered. Moreover, our curriculum at ULM only briefly covers toxicology risk assessment in general. Thus, I requested Supplemental Training for Education (STEP) funding to participate in the "Qualitative and Quantitative Risk Assessment Online” course by the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) in order to fill this gap. JIFSAN is jointly administered by the US Food and Drug Administration and the University of Maryland.
With the help of the SOT STEP Award, I could participate in this wonderful, extensive course directed by Dr. Charles Yoe, who has vast experience in and knowledge of this subject. The course is structured so that the content is appropriate and useful for both newer and more experienced professionals. There is an individual or group exercise for almost all of the 14 modules that provides experiential training for the topics covered. After each exercise, the instructor would provide his feedback through audio/video recording.
Some of the learning objectives of the course included the following:
- Introduction to the @RISK and Precision Tree software
- Define and discuss the core elements of risk characterization
- Define, distinguish, and discuss the significance of uncertainty and variability specific for the risk assessor and risk manager
- Identify the probability distributions most useful to a risk assessor
- Identify and discuss the two steps of the Monte Carlo process
- Choose a proper probability distribution for a given set of data
- List the elements of a good screening process
- Define and discuss the worst-case scenario
- Use one or more qualitative risk assessment techniques
- Construct a simple event tree model.
Every participant interacted on the course portal on a regular basis. On the common forum, the instructor had posted several short questions for us to answer to provide a brief introduction. Participants learned the educational background, professional experience, and current affiliation of others in the course. The way the instructor provided routine examples to make information clear was commendable and I mastered almost every objective stated above.
I realized that while the basic component of the risk characterization remains the same, the safety assessment of food products is a lot different from that for cosmetic/consumer products. Through this course, I learned that probability is the language of uncertainty and variability. After this course, I can easily distinguish the discrete data set from the continuous ones and I am now familiar with the most frequently used probability distributions for risk assessment and the Monte Carlo process. Nonetheless, when some of the fellow participants responded very quickly to the group exercise for some modules largely dealing with the core statistical analysis, I realized that I need to learn more in this area to become a competent risk assessor.
The instructor was always just an email away and made sure that all the participants were on the same page throughout the course. Dr. Yoe was open to all questions within the scope of the course, and he would explain everything by customized audio/video clips. Moreover, he provided us with several fundamental articles, WHO expert consultation reports on the risk assessment of microbiological hazards in foods, web links to online databases, and reference to his own book, Principles of Risk Analysis: Decision Making Under Uncertainty. Moreover, we were given a month extra to download the content of the course for our future reference.
I feel that this course helped me to learn some qualitative and quantitative tools used for the risk assessment of food products. Meeting some food safety professionals from around the world was an added perk. Moreover, this class provided me with some basic knowledge and literature that will be very helpful in the near future as I step into the real world of toxicology risk assessment all over again. I realized that applying “uncertainty factors (10-fold)” and “modifying factors” are not the only way of dealing with prevalent uncertainty during the toxicology risk assessment. Finally, I strongly believe that marrying my mechanistic toxicology laboratory experience with the risk assessment knowledge will help me grab a dream career opportunity because my background has been enhanced by this training opportunity.