Study in Progress


Review of EPA's draft paper State of the Science on Nonmonotonic Dose Response - 07/23/13

Statement of Task

An ad hoc committee will conduct a scientific review of EPA's draft paper, State of the Science on Nonmonotonic Dose Response. Specifically the committee will review and provide a brief report on the following:

- EPA's analysis of the potential existence of nonmonotonic dose-response curves (NMDRCs) for chemicals. Has EPA fairly and soundly evaluated the weight of evidence and has it reached conclusions supported by the available studies?

- EPA's evaluation of the studies and expert opinion (including the completeness of the database) used to assess whether current chemical testing strategies capture adverse effects potentially represented by NMDRCs. To what extent do the available studies capture adverse effects?

- EPA's scientific rationale used to evaluate whether the state of the science influences EPA?s weight of evidence conclusions and the implications for risk assessment.

For the issues addressed in the bullets above, the committee will consider:

- Is EPA's State of the Science document scientifically sound and of high quality?

- Has EPA selected studies of suitable breadth, relevance, and quality?

- Has EPA fairly and soundly evaluated and integrated the weight of evidence from the diversity of studies (epidemiological, mode-of-action, animal testing)?

- Are the assumptions valid and reasonable?

- Are the conclusions valid and supported on the basis of EPA?s assessment and the literature?

- Are there potential limitations or data gaps that would substantially impact the conclusions?