title: 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.
authors.affiliation: a Parker Doe Partnership LLP , Frodsham , Cheshire , UK .
authors.forename: John E
authors.initials: JE
authors.lastname: Doe
authors.affiliation: b DuPont Haskell Global Centers for Health & Environmental Sciences , Newark , DE , USA .
authors.forename: Deborah R
authors.initials: DR
authors.lastname: Lander
authors.affiliation: c ILSI Health and Environmental Sciences Institute , Washington, DC , USA .
authors.forename: Nancy G
authors.initials: NG
authors.lastname: Doerrer
authors.affiliation: d Syngenta Crop Protection LLC , Greensboro , NC , USA .
authors.forename: Nina
authors.initials: N
authors.lastname: Heard
authors.affiliation: e US Environmental Protection Agency, NHEERL, Research Triangle Park , USA .
authors.forename: Ronald N
authors.initials: RN
authors.lastname: Hines
authors.affiliation: f US Environmental Protection Agency, Office of Pesticide Programs , Washington, DC , USA .
authors.forename: Anna B
authors.initials: AB
authors.lastname: Lowit
authors.affiliation: d Syngenta Crop Protection LLC , Greensboro , NC , USA .
authors.forename: Timothy
authors.initials: T
authors.lastname: Pastoor
authors.affiliation: g ExxonMobil Biomedical Sciences, Inc. , Annandale , NJ , USA .
authors.forename: Richard D
authors.initials: RD
authors.lastname: Phillips
authors.affiliation: h Arysta LifeScience North America , Cary , NC , USA , and.
authors.forename: Dana
authors.initials: D
authors.lastname: Sargent
authors.affiliation: i Monsanto Company , Saint Louis , MO , USA.
authors.forename: James H
authors.initials: JH
authors.lastname: Sherman
authors.affiliation: c ILSI Health and Environmental Sciences Institute , Washington, DC , USA .
authors.forename: Jennifer
authors.initials: J
authors.lastname: Young Tanir
authors.affiliation: c ILSI Health and Environmental Sciences Institute , Washington, DC , USA .
authors.forename: Michelle R
authors.initials: MR
authors.lastname: Embry
mesh_terms: D000818:Animals; D003657:Decision Making; D004781:Environmental Exposure / Q000009:adverse effects* / Q000032:analysis; D006801:Humans; D057148:Insecticide-Treated Bednets / Q000009:adverse effects*; D023421:Models, Animal; D011722:Pyrethrins / Q000633:toxicity*; D018570:Risk Assessment; D018675:Toxicity Tests; D014481:United States; D014484:United States Environmental Protection Agency
chemical_list: D011722:Pyrethrins
keywords: Integrated testing strategy; pyrethroid; risk assessment; tiered approach