The question of need for standardization and validation of the complex methods to establish the maximum concentration limit (MCL) ofbiotechnological strains in the water of water bodies is under discussion. On the basis of the experimental studies it has been shown that a unified quantitative criterion for safety could not to be recommended for biotechnological strains and therefore requires the study of each strain in order to substantiate the safe level in water of water bodies. Proposed biosafety program should include the study of pathogenic properties in acute experiments and specific effects in subchronic experiments to study the influence of strains on the process of water purification and a risk assessment of transformation products of chemicals and the justification of the safety factor when establishing MCL t in terms of the toxic effect.
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