Sanitary-epidemiological audit in Russia and abroad: challenges and growth prospects (analytical review)

The shaping the system of control and surveillance activities in the Russian Federation, which affects the bodies of the sanitary-epidemiological surveillance, requires the development of new forms of cooperation between authorities and legal entities, individual entrepreneurs and population. Such a form may be represented by the sanitary and epidemiological audit as an independent objective assessment of reputable third parties. The audit is intended to check the compliance with the mandatory requirements of the economic entities, performing economic or other activities. The sanitary-epidemiological audit may be associated with a system of certification for compliance with sanitary requirements and may assume the documented confirmation of the compliance issued by the authorized persons. The sanitary-epidemiological audit and the compliance certification to mandatory sanitary requirements can make an alternative to the planned supervision activities on facilities attributed to the category of low and moderate risk of harm to human health. The Russian sanitary legislation does not recognize the sanitary-epidemiological audit as a form of conformity assessment. The analysis of the international experience shows that it is necessary to consolidate the general rules and regulations of the sanitary-epidemiological audit at the legislative level and to develop a set of sublegislative documents in order to implement these norms. The crucial is a creation of the national system capable to regulate the registration and functioning of the organization having a right to conduct the audit activities in the field of hygienic safety. It is reasonable to develop the regulation on the list-register of auditors and to create a special training system for the auditors, who possess the methodology for health risk assessment. The key aspect of the successful introduction of the audit is a granting of presences to the economic entities having compliance certificates as a result of voluntary sanitary-epidemiological audit. The authorities for the accreditation and monitoring of the audit firms in the field of sanitary and epidemiological safety can be given to a federal executive body competent in this field.