Use of the RISK21 roadmap and matrix: human health risk assessment of the use of a pyrethroid in bed netting

Abstract

The HESI-coordinated RISK21 roadmap and matrix are tools that provide a transparent method to compare exposure and toxicity information and assess whether additional refinement is required to obtain the necessary precision level for a decision regarding safety. A case study of the use of a pyrethroid, "pseudomethrin," in bed netting to control malaria is presented to demonstrate the application of the roadmap and matrix. The evaluation began with a problem formulation step. The first assessment utilized existing information pertaining to the use and the class of chemistry. At each stage of the step-wise approach, the precision of the toxicity and exposure estimates were refined as necessary by obtaining key data which enabled a decision on safety to be made efficiently and with confidence. The evaluation demonstrated the concept of using existing information within the RISK21 matrix to drive the generation of additional data using a value-of-information approach. The use of the matrix highlighted whether exposure or toxicity required further investigation and emphasized the need to address the default uncertainty factor of 100 at the highest tier of the evaluation. It also showed how new methodology such as the use of in vitro studies and assays could be used to answer the specific questions which arise through the use of the matrix. The matrix also serves as a useful means to communicate progress to stakeholders during an assessment of chemical use.

Keywords: Integrated testing strategy; pyrethroid; risk assessment; tiered approach.

Figure 1.

The RISK21 roadmap.

Figure 2.

Application of the ranges for exposure and toxicity on the RISK21 matrix to form the exposure/toxicity intersect area for net dipping for the first assessment. The area to the left of the yellow shading indicates where exposure is below the human safe level for toxicity.

Figure 3.

Application of the ranges for exposure and toxicity on the RISK21 matrix to form the exposure/toxicity intersect area for sleeping under the net for the first assessment. The area to the left of the yellow shading indicates where exposure is below the human safe level for toxicity.

Figure 4.

Application of the ranges for exposure and toxicity on the RISK21 matrix to form the exposure/toxicity intersect area for net dipping for the second assessment. The area to the left of the yellow shading indicates where exposure is below the human safe level for toxicity.

Figure 5.

Application of the ranges for exposure and toxicity onto the RISK21 matrix to form the exposure/toxicity intersect area for sleeping under the net for the second assessment. The area to the left of the yellow shading indicates where exposure is below the human safe level for toxicity.

Figure 6.

Application of the ranges for exposure and toxicity on the RISK21 matrix to form the exposure/toxicity intersect area for net dipping for the third assessment. The area to the left of the yellow shading indicates where exposure is below the human safe level for toxicity.

Figure 7.

Application of the ranges for exposure and toxicity onto the RISK21 matrix to form the exposure/toxicity intersect area for sleeping under the net for the third assessment. The area to the left of the yellow shading indicates where exposure is below the human safe level for toxicity.