Scientific justification of the exposure and effect biomarkers in terms of proving health impact when identifying environmentally- determined unacceptable risk

The article describes the elements of scientific and methodological approaches proposed for establishing of the causality of health effects in the detection of environmentally-determined unacceptable risk. Research experience and the results of own studies allowed to develop a biomonitoring system that includes exposure and effect biomarkers intended to generate evidence basis to prove the connection between health effects and micro- and macroscale chemical factors. The introduction and application of the new high-sensitive and analytical techniques has allowed to analyze the mechanisms behind the development of the bodily responses to the external impact at the earliest stages (cellular and molecular level). About 30 criteria of the biochemical, immune, hematological and molecular-genetic effects markers that characterize genetic polymorphism, the failure of oxidation-antioxidant processes, including at the cell DNA level, of the proteomic profile, bone metabolism, neuro-endocrine regulation hematopoiesis, development of specific sensitization, activation of cell death that reflect pathomorphosis of the blood, respiratory, gastrointestinal, cardiovascular, and central nervous system disorder, the development of genetic instability and chromosomal abnormalities. Scientific justification of the developed methodology is based on the principles of evidence-based medicine, epidemiological analysis, theoretical knowledge, and is consistent with the international risk assessment practice.