Draft report of the Working Group on Variation and Uncertainty in Toxicology

COT had identified a need to review the approaches that are currently used, or that might in future be used, for dealing with variability and uncertainty in the biological data utilised in the risk assessment of chemicals in food.

The terms of reference of the working group were:

• review the evidence of the basis and range of variability in response to toxic chemicals
• consider sources of uncertainty in hazard identification and characterisation
• consider the appropriateness of uncertainty factors customarily used to extrapolate toxicological data from animals to humans
• consider the appropriateness of uncertainty factors customarily used to allow for variation within the human population, including specific subgroups such as children
• consider other methods that might be used in setting acceptable or tolerable intakes for food chemicals
• consider how to express the level of confidence that one can have in the risk assessment

Since its first meeting on 14 November 2003, the working group has met a further four times. It has compiled and reviewed information on variation and uncertainty in toxicology in relation to its terms of reference. The Working Group has prepared a draft report, which is now available for comment.

The report includes chapters on:

• an introduction to risk assessment
• variability in hazard characterisation
• sources of variability in toxicokinetics
• sources of variability in toxicodynamics
• sources of uncertainty in hazard characterisation
• variability and uncertainty in data in studies from humans
• developmental neurotoxicity
• endocrine modulation
• adequacy of current approaches
• other approaches
• conclusions and recommendations

Please note that this is a draft report and the text has not been fully edited, nor has it been agreed by COT.

This consultation has been prepared in accordance with the HM Government Code of Practice on Consultation, which states that a consultation must follow better regulation best practice, including carrying out an Impact Assessment (Regulatory Impact Assessment in Scotland). The assessment is included in the consultation documents.

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Consultation feedback questionnaire (Word)

Consultation feedback questionnaire (pdf)

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