THE PROBLEM

You are asked to help with the registration of VineGuard, a fungicide used on table grapes. As an innovative scientist who always appreciates a challenge, you want to show that the ecological and human health risk assessment necessary for the registration of this product can be entirely based on non-animal data.

VineGuard should be used as soon as disease is observed, and applied 3 to 6 times during growing season through harvest depending on disease pressure using ground equipment (ground boom, air blast sprayer).

The current risk assessment paradigm is summarized in Sewell et al. 2021 available HERE as well as other helpful reading materials can be found in the background materials.

Your goal is to create a convincing argument assuring safe use and protection of human health and the environment for registering this fungicide.

As you develop your solution, you are asked to:

Consider the overall risk assessment.

  • Develop a problem statement addressing the risk assessment for the scenario described above.
  • Develop a visual conceptual model representing all relevant human and environmental exposure pathways for the scenario described above. (You could use the RISK21 conceptual model builder available HERE or design your own conceptual model).

Narrow the risk assessment scope.

You can choose to work on all or a few of the routes of exposures highlighted in your conceptual model (for human and/or environmental exposure).

  • Reformulate your problem statement to specifically define the focus of your work.
  • Modify your conceptual model so it reflects your problem statement. (You could simply highlight the exposure pathways you decided to address.)

Choose your registration scenario.

For this exercise, you can choose between three different registration scenarios:

  • VineGuard is a novel active ingredient (AI) displaying a new mode of action.
  • VineGuard is a new active ingredient with a known mode of action (MOA).
    • You can work on the MOA of your choice. Fungicide MOAs can be found here.
  • VineGuard is not a new active ingredient, but it needs to be re-registered and/or is being considered for new uses. 

Specific questions.

Specific questions are provided in the reporting template.