Human Data Initiative
For historical reasons, clinical toxicology/poisons information and regulatory toxicology/risk assessment exist in parallel worlds, having developed as separate disciplines. They share common objectives to protect human health. In 2001, an initial meeting "Bridging the Gap" found that there was much scope for using existing observational human data to improve the understanding about risk assessment between clinicians, toxicologists and risk assessors and resolving uncertainties associated with the extrapolation of animal data to humans.
In 2003 the Intergovernmental Forum of Chemical Safety (IFCS) gave further weight to these initial findings by inviting IPCS to take the lead in the development of guidance on and mechanisms for collecting, disseminating and utilizing clinical and exposure data from human observations. Based on the outcomes of a IPCS Workshop held in Cardiff, 2004, IPCS is in the process of developing an action plan to address the IFCS recommendation. Linkages between the collection of OHS-related human data, incidents involving acutely toxic pesticides and the children's environmental health initiative are being strengthened in the context of the IFCS recommendation.
A framework to describe the actions needed to improve the use of human data in risk assessment is being prepared in response to the IFCS recommendation. This recommendation has also been reflected in the Global Plan of Action being developed as part of the Strategic Approach to International Chemicals Management (SAICM). The framework will provide a basis for better protecting citizens from chemical threats and for strengthening the interaction between health-sector professionals and risk assessors. Such interaction is necessary to support improvements in the predictive value of risk assessment and the effectiveness of risk management and prevention. The framework is being built around the different sources and types of human data available as well as how this data can contribute to improving risk assessment.
A collaborative Workshop was organised by IPCS together with the European Commission's Joint Research Centre Institute for Health and Consumer Protection ( EC JRC IHCP), the Federal Institute for Risk Assessment, Germany (BfR), European Centre for Ecotoxicology of Chemicals (ECETOC) and the European Association of Poisons Centres and Clinical Toxicologists (EAPCCT). The Workshop was held at the time of the XXV International Congress of the EAPCCT in recognition of the importance of improving the risk assessment of consumer products and the experience of poisons centres in dealing with cases of human exposure to consumer products. A copy of the Workshop Report is available below.