Legal analysis of the use of health risk assessment in the field of sanitary and epidemiological well-being of the population

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Abstract

In recent years, when regulating relations in the field of ensuring the sanitary and epidemiological well-being of the population, risk-oriented supervision, and the population health risk assessment have been increasingly applied. The usage of these effective tools requires a clear legal framework. The article represents the analysis of the legal aspects of the usage of public health risk assessment and risk-based control (surveillance) in the field of the sanitary-epidemiological well-being of the population in the Russian Federation. Special attention is drawn to the problems of applying the methods for state sanitary-epidemiological surveillance. The analysis of draft laws related to this area and the legislation and experience of other countries is performed. The analysis of modern legislative changes regarding the application of risk-based supervision and the application of public health risk assessment allows concluding that the methodology for health risk assessment is an important tool in regulating relations in the field of ensuring the sanitary and epidemiological well-being of the population. Currently, there is a certain legal and regulatory framework for its use. But it needs improvement. As the experience of the “regulatory guillotine” carried out in many countries shows, this procedure allows eliminating many contradictions existing in regulatory legal acts. A risk-based approach is enshrined in the legislation of all EAEU member countries. At the same time, an analysis of the regulatory framework showed that a risk-oriented model was formed to a greater extent and is functioning in terms of classification (categorization) by the risk of harm to the health of legal entities (LE), individual entrepreneurs (IP) or their activities than risk-based supervision of products traded in the consumer market. The transition to a new model of state control (supervision) requires legal consolidation of the risk management system in the law on sanitary and epidemiological well-being and taking into account the experience of the EU and EAEU countries in this area.

About the authors

Aleksandr O. Karelin

I.P. Pavlov First Saint-Petersburg State Medical University

Author for correspondence.
Email: karelin52@mail.ru
ORCID iD: 0000-0003-2467-7887

MD, Ph.D., DSci., Professor, Chief of the Department of General Hygiene and Ecology, I.P.Pavlov First Saint-Petersburg State Medical University, Saint-Petersburg, 197022, Russian Federation

e-mail: karelin52@mail.ru

Russian Federation

A. Yu. Lomtev

Institute of Design, Ecology and Hygiene

Email: noemail@neicon.ru
ORCID iD: 0000-0003-3183-2582
Russian Federation

G. B. Yeremin

North-West Public Health Research Center

Email: noemail@neicon.ru
ORCID iD: 0000-0002-1629-5435
Russian Federation

N. A. Mozzhukhina

I.I. Mechnikov North-West State Medical University

Email: noemail@neicon.ru
ORCID iD: 0000-0002-8051-097X
Russian Federation

P. A. Ganichev

North-West Public Health Research Center

Email: noemail@neicon.ru
ORCID iD: 0000-0003-0954-8083
Russian Federation

References

  1. Malysheva A.G., Kozlova N.Yu., Yudin S.M. Unaccounted chemical hazard of chemical transformation processes in assessing the effectiveness of technology application. Gigiena i sanitariya [Hygiene and Sanitation, Russian journal]. 2018; 97 (6): 490–7. (in Russian)
  2. Avaliani S.L., Novikov S.M., Shashina T.A., Dodina N.S., Kislicin V.A., Mishina A.L. The problem of improving the environmental quality management system based on a population health risk analysis. Gigiena i sanitariya [Hygiene and Sanitation, Russian journal]. 2014; 6: 5–8. (in Russian)
  3. Shur P.Z., Zajceva N.V. Health risk assessment when substantiating hygiene criteria for food safety. Analiz riska zdorov’yu [Health Risk Analysis]. 2018; 4: 43–56. (in Russian)
  4. Novikov S.M., Fokin M.V., Unguryanu T.M. Actual issues of the methodology and development of evidence-based assessment of risk to public health when exposed to chemicals. Gigiena i sanitariya [Hygiene and Sanitation, Russian journal]. 2016; 95 (8): 711–6. (in Russian)
  5. Krasovskij G.N., Egorova N.A., Bykov I.I. Methodology for harmonization of hygienic standards of substances in water and its implementation in the improvement of water-sanitary legislation. Vestnik RAMN [Bulletin of RAMS]. 2006; 4: 32–6. (in Russian)
  6. Zholdakova Z.I., Sinicina O.O., Pechnikova I.A., Savostikova O.N. On the legal consolidation of the use of health risk assessment methods in the legislation of the Russian Federation, which regulates the sanitary and epidemiological welfare of the population. Analiz riska zdorov’yu [Health Risk Analysis]. 2018; 2: 4–13. (in Russian)
  7. Karelin A.O., Lomtev A.Yu., Eremin G.B., Mozzhukhina N.A. On the legal consolidation of the use of health risk assessment methods in the legislation of the Russian Federation, which regulates the sanitary and epidemiological welfare of the population. Zdravoohranenie Rossiyskoy Federatsii. 2016; 60 (5): 264–8. (in Russian)
  8. Karelin A.O., Mozzhukhina N.A., Eremin G.B., Maj I.V., Lomtev A.Yu., Kiselev A.V. Use of a risk management system to improve sanitary and epidemiological control and supervision. Uchenye zapiski Sankt-Peterburgskogo gosudarstvennogo meditsinskogo universiteta imeni akademika I.P. Pavlova. 2015; XXII (1): 81–5. (in Russian)
  9. Zholdakova Z.I., Yudin S.M., Sinicina O.O., Budarina O.V., Dodina N.S. Prospects for improving the legal and methodological measures for environmental quality management. Gigiena i sanitariya [Hygiene and Sanitation, Russian journal]. 2018; 97 (11): 1026–31. (in Russian)
  10. Popova A.Yu., Gurvich V.B., Kuzmin S.V., Mishina A.L., Yarushin S.V. Current Issues of Health Risk Assessment and Management. Gigiena i sanitariya [Hygiene and Sanitation, Russian journal]. 2017; 96 (12): 1125–9. (in Russian)
  11. Malyh O.L., Kochneva N.I., Nikonov B.I., Shevchik A.A., Cepilova T.M. Integrated health risk management system at the regional and municipal levels. Gigiena i sanitariya [Hygiene and Sanitation, Russian journal]. 2017; 96 (12): 1136–40. (in Russian)
  12. Kuzmin S.V., Gurvich V.B., Dikonskaya O.V., Nikonov B.I., Malyh O.L., Yarushin S.V. et al. Social and hygienic monitoring and information and analytical systems for assessing and managing risk to public health and a risk-based model of supervisory activity. Gigiena i sanitariya [Hygiene and Sanitation, Russian journal]. 2017; 96 (12): 1130–6. (in Russian)
  13. Popova A.Yu., Zajceva N.V., Maj I.V., Kiryanov D.A. Regulatory and methodological aspects of integrating socio-hygienic monitoring and a risk-based model of supervision. Analiz riska zdorov’yu [Health Risk Analysis]. 2018: 4–12. (in Russian)
  14. Popova A.Yu. Risk analysis - a strategic direction for food safety. Analiz riska zdorov’yu [Health Risk Analysis]. 2018; 4: 4–12. (in Russian)
  15. Popova A.Yu., Zajceva N.V., Maj I.V. Experience in methodological support and practical implementation of a risk-based model of sanitary and epidemiological surveillance: 2014-2017. Gigiena i sanitariya [Hygiene and Sanitation, Russian journal]. 2018; 97 (1): 5–9. (in Russian)
  16. Rahmanin Yu.A., Mihajlova R.I. Food Risk Analysis and Water Factor Safety. Analiz riska zdorov’yu [Health Risk Analysis]. 2018; 4: 31–42. (in Russian)
  17. Ulbriht K., Dzhamankulov N. Sistema kontrolya bezopasnosti pishevoj produkcii v Evropejskom soyuze i Evrazijskom ekonomicheskom soyuze Food Safety Control System in the European Union and the Eurasian Economic Union. Torgovaya politika. 2016; 6 (2): 41–84. (in Russian)
  18. CAC/GL 62-2007 Working Principles for Risk Analysis for Food Safety for Application by Governments. Rome; 2007.
  19. Guidelines On The Application Of General Principles Of Food Hygiene To The Control Of Listeria Monocytogenes In Foods. CAC/GL61-2007. 2007. Available at: http://www.fao.org/input/download/standards/10740/CXG_061e.pdf
  20. Ingested Nitrate and Nitrite and Cyanobacterial Peptide Toxins. International Agency for Research on Cancer (IARC), Monographs on the Evaluation of Carcinogenic Risks to Humans. Geneva: World Health Organization; 2010. 94 p.
  21. FAO Risk based imported food control. Rome; 2016. Available at: http://www.fao.org/3/a-i5381e.pdf
  22. Guidance for risk assessment of food and feed from genetically modified plants. EFSA Journal. 2011; 5 (9): 2150.
  23. Zajceva N.V., Maj I.V., Sychik S.I., Fedorenko E.V., Shevchuk L.M. Analysis of the legal and methodological framework of risk-based supervision of products traded in the consumer market: challenges and development prospects in the Eurasian Economic Union. Analiz riska zdorov’yu [Health Risk Analysis]. 2017; 4: 4–22. (in Russian)
  24. Attrey D.P. Regulatory requirements for labeling, health, and nutritional claim. In: Food Safety in the 21st Century: Public Health Perspective. Academic Press; 2016: 497–506.
  25. McEvoy J.D.G. Emerging food safety issues: An EU perspective. Drug Testing and Analysis. 2016; 8 (5–6): 511–20. https://www.doi.org/10.1002/dta
  26. New Legislative Framework // European Commission: Single Market for Goods. Available at: https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_en
  27. Better regulation in Europe: Executive summaries. OECD; 2010. Available at: www.oecd.org/gov/regulatory-policy/45079126.pdf
  28. Gaevskiy I.V., Zaitseva N.V., May I.V., Karymbaeva S.T., Sychik S.I., Fedorenko E.V. On the methodological support of risk-oriented supervision in the single economic space of the Eurasian Economic Union. Analiz riska zdorov’yu [Health Risk Analysis]. 2019; 1: 14–6. (in Russian)
  29. Osaulenko L.N. Ensuring food safety and consumer protection in the law of the Eurasian Economic Union. Analiz riska zdorov’yu [Health Risk Analysis]. 2018; 4: 24–30. (in Russian)
  30. Fedorenko E.V. Legal basis for the application of risk analysis methodology in ensuring food safety in the Eurasian Economic Union and the Republic of Belarus. Analiz riska zdorov’yu [Health Risk Analysis]. 2015; 3 (13): 8. (in Russian)
  31. Methodology for assessing risks to public health under the influence of chemical, physical and biological factors to determine the safety indicators of products (goods). Moscow: Yumanite Media; 2014.
  32. Leonov O.A., Shkaruba N.Zh. HASSP system elements in the production of cooked smoked sausages. Food Industry: Science and Technology. 2018; 40 (2): 44–52. (in Russian)
  33. Bortoletto A.M., Silvello G.C., Alcarde A.R Good manufacturing practices, hazard analysis and critical control point plan proposal for distilleries of cachaça. Sci Agric. 2018; 75 (5): 432–8.

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Copyright (c) 2024 Karelin A.O., Lomtev A.Y., Yeremin G.B., Mozzhukhina N.A., Ganichev P.A.


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