The risk assessment Process


To set a limit for any chemical, risk assessors follow a process. Risk assessors start by collecting scientific data on the health effects of the chemical of interest and figure out the amounts of this chemical needed to produce those health effects under different conditions. When possible, they also try to estimate the amounts of this chemical people could possibly be exposed to.  Risk assessors then bring all of this information on health effects and exposures together to derive a limit that protects human health. 


Risk assessment is a bit like life, from Forest Gump's viewpoint. As he said "Life is like a box of chocolates, you never know what you're gonna get".  A large part of this relates to the fact that there are no ideal data sets, so risk assessors must make estimations, assumptions and deal with uncertainty and variability, which requires them to make scientific and policy judgements.  The limit derived is ultimately a reflection of all of these collective judgements.


The good news is that frameworks have been developed by the risk assessment community to help guide risk assessors in these judgements. Despite this, risk assessors still differ in the process they follow and the judgements they apply. As a result,  limits can sometimes differ, even for the same or similar substances and exposure situations. While some of these differences are expected and can be easily understood, others are harder to figure out. Part of the problem rests in how risk assessments are written. Most risk assessments are written as narrative texts, and this style of document doesn't always lend itself well to following back how and why decisions were made.


where does safedose come in?


SafeDose was formed by Dr. Reena Sandhu, a risk assessor that has written or reviewed hundreds of risk assessments. It was born out of many moments of asking "Wouldn't it be awesome if..." Questions such as: "Wouldn't it awesome if I didn't continually have to look up numbers in look-up tables or do risk assessment math with calculators?" and  "Wouldn't it be awesome if I had access to what the guidances recommend that I do in this situation, when I'm actually in that situation?"  and "Wouldn't it be awesome if I could see all my study and exposure data at the same time that I set my limit?"


 SafeDose has taken the large list of what-ifs to design tools that will improve the transparency, rigor and repeatability of risk assessment and hopefully also help to make it more enjoyable. These tools are designed to fit in with other initiatives that want to achieve the same end goal, like systematic review. Since computational models and studies done in non-living organisms will form a much larger part of risk assessment in the future, having a platform that is flexible and can handle lots of data points easily adapt to incorporating data from a variety of data streams is an advantage.


WHat does safedose want?


It takes a community to build these tools.


If you are a risk assessor, we'd like to know about your "Wouldn't it be awesome if" wish list of things that you would like to see in a software product. Anything that would make your life easier or your risk assessments better, we want to hear about.


If you would like to know more about what SafeDose is developing, or are interested in collaborating or funding this project, please Contact Us