Unsung Heroes of the Scientific Process: Risk Assessments

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Unsung Heroes of the Scientific Process: Risk Assessments

July 25, 2023 | all blog |

Science, particularly in the environmental management world, can sometimes feel like a series of box checking steps. But miss one box and an entire project could fail or a regulatory agency could come calling. The penalties for cutting corners or missing a step are steep, making an overall project strategy and approach a critical component in a projects’ success. In this installment of our Unsung Heroes of the Scientific Process Series, we’re taking a look at Risk Assessments.

In a nutshell, Risk Assessments and their guiding strategies and taskmasters keep projects safe, on track, and on budget. These decisions impact timing, financial investment, and sometimes drive the state-of-the-science for an industry. They are so important to the project process that we can safely say that anyone working anywhere in the vast network of our chemical industries, from pharmaceuticals to personal care products to agricultural projects and beyond, has, at some point, worked under the guidance of a Risk Assessment Strategy. 

But what goes into a Risk Assessment Strategy? While exact details will vary by industry and project goals, there are fundamental steps that, together, create a seamless project path. For instance, regardless of the industry, the classic Risk Assessment process begins with a problem formulation. This step first questions whether there are risks associated with the project before specifying what risks are involved. Once identified, the strategy then tackles and defines the approach for answering said risks, including endpoints. 

Next, any hazard identifications can take place. These identifications will guide the focus for potential risks to humans and ecological compartments. Hazard and exposure assessments are then conducted to characterize the toxicity endpoints and estimate the expected exposure concentrations. A risk characterization combines the factors of both hazard and exposure in order to quantify risk.

Once risk has been characterized, the Risk Assessment will strategize steps for managing any issues identified, through management, mitigation, refinement, etc. This process is typically ever-evolving. Typically, a chemical risk assessment does not have a clean start and finish due to 1) regulation changes, 2) chemical uses changes, and 3) technology changes.

A Risk Assessment Strategy is not a single use report. There are times when it is important to revisit a Risk Assessment for modifications, or re-registration and, at that point, it it is imperative that the user has a thorough understanding of existing data, data quality, and the regulatory landscape. For example when clients ask our Waterborne scientists to revisit their previously created Risk Assessment Strategies, we most often discover:

  • Opportunities for waiver arguments in place of conducting an expensive and time-consuming laboratory study, saving hundreds of thousands of dollars. 
  • Data gaps that would have led to delays with regulatory agencies down the line. 
  • Novel approaches or bridges between chemical types or concepts. In these cases, communication with the regulatory agencies and influence by expertise is critical.

Given the above it’s easy to see how Risk Assessments and their strategies are unsung heroes within the scientific world. Their process seldom ends; as chemicals and industries change, so must their respective Risk Assessment Strategies. By following their steps and periodically recalibrating the plan, companies can continue to navigate the complex regulatory world.

We have experience with multiple regulatory agencies and have been successful at developing tools and applying risk assessment concepts across industries and agencies.