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Provide Examples where Risk Characterisations can be Conducted with the Existing (and Possibly Inadequate) Data Sets

Background

The methodologies currently used in human health risk assessment are limited to qualitative descriptions. Few validated methodologies exist to quantitatively characterise the degree of uncertainty associated with most steps of the risk assessment paradigm. The human health risks of most chemical exposures are inferred from animal studies, based on the premise that laboratory animals are suitable experimental surrogates for humans. In addition, the expected incidence of chemical-induced disease in the human population is frequently extrapolated from high experimental doses to low environmentally relevant levels. However, recent research in this area, such as the use of expert judgement in quantifying uncertainty, indicates that methods can be developed which characterise the magnitude of uncertainty in risk assessments in quantitative terms. Quantitative descriptors of uncertainty are expected to lead to more informed risk management decisions.

Objectives

Proposals
Proposals submitted for consideration should follow the format of the application from'Application for a CEFIC-LRI Grant' and should address the following areas under individual subheadings:
The title of the research proposal.
The name and affiliation of the principal investigator and the laboratory or laboratories in which the research will be conducted.
Evidence of the principal investigator's knowledge of, and contribution to, current understandings of the role of EU risk assessment of human health endpoints.
A clear definition of the research objectives, including a description of the mechanistic basis for the proposed research.
A clear plan of investigation, including a clearly defined milestone plan that identifies all critical decision points in the research programme.
A detailed breakdown of costs.
Monitoring
The successful applicant(s) will be required to submit a progress report every 6 months during the course of the programme. At the end of the project a detailed review of the project and the achievements made will be provided by the principal investigator. The successful applicant(s) will also be required to prepare for publication a manuscript describing the work undertaken and the results achieved.

Scope

Provide examples where risk characterisations can be conducted with the existing (and possibly inadequate) data sets. Possible examples could be taken from the EU Priority Chemicals HEDSET programme.
Use these examples to stimulate debate within the context of the current political desire to see completed'data sets' prior to embarking on any process of risk assessment.
Using non-medical examples, review data sets and apply IPCS and other approaches in setting variable uncertainty factors (UF).
Consider the range of UF required when data sets are inadequate such as the need for route to route extrapolation, data gaps, etc.
Consider the impact of exposures to chemical mixtures (other than food) and their implications for risk assessments.

Cost: Estimated costs of $35,000 for one year (12 months), to commence H2/2000.

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