HEALTH RISK ASSESSMENT FROM IMPACT OF NANO-, NANOBIOMATERIALS:METHODS OF EVALUATION AND PRACTICAL APPLICATION

An approach to the development of methodology for health risk assessment (HRA) for the effects of new environmental factors: nanoparticles and nanobiomaterials (NP/NBM) – products of modern nano-, nanobiotechnology has been proposed. The experience from developing and applying HRA methodology for impact of ionizing radiation, harmful chemicals and other risk sources is used. This approach is based on elaborating the general HRA methodology applicable to any source of harmful effect. HRA methodology for NP/NBM effects as well as other specific HRA methods including their simplified versions are developed on the basis of the general methodology. Main items of this approach to developing HRA methodology (risk indices, their definition and calculation formulas, model for dose-response dependencies, single and extended exposures to a harm factor, risk competition, etc.) are shortly described. The special risk index most suitable for elaborating the health safety standards (HSSs) and comparison of risks in the different areas of human activity has been proposed. The approach to the risk standardization (setting of HSSs and other levels of decision-making for safety) is described. In this approach HSSs and other safety levels are sequentially set along the scheme: main universal HSSs → main branch HSSs → derivative (secondary) HSSs in indices suitable for the practical application. This approach of development of HRA methodology and the risk standardization allows solving the actual for the present time problem of the harmonization of HSSs in different areas of human activity as well as in different countries.