1. 1 International Iran nanosafety congress INSC2014”, Tehran, 19, 20 February 2014 Demin V.F., Demin V.A., Kashkarov P.K. NRC “Kurchatov institute”, Moscow, Russia Methodological aspects of the health risk assessment in application to nanosafety

2. 2 NRC “Kurchatov institute”, Moscow, Russia General information (1) In the past: Institute of atomic power main research nuclear center of USSR Current: National research center status “Kurchatov institute” INSC 2014 19-20 February 2014, Tehran

3. 3 NRC “Kurchatov institute”, Moscow, Russia General information (2) Multi-disciplinary research directions : Nuclear power and advanced power technologies Thermonuclear fusion Fundamental research and international mega projects Informational technologies and systems Technologies and developments of double purpose Nanotechnologies and nanomaterials Biomedical technologies and nuclear medicine … INSC 2014 19-20 February 2014, Tehran

4. 4 Needs in health risk assessment (1)  safety regulation (standards of safety, …)  technical safety measures,  social-hygienic monitoring,  medical safety measures,  etc. Results of health risk assessment (HRA) as well as toxicological data are needed to support decisions on: INSC 2014 19-20 February 2014, Tehran

5. 5 Past experience in radiation protection Needs in health risk assessment (2) Change of dose limits and approaches to them in time INSC 2014 19-20 February 2014, Tehran

6. 6 Development of risk assessment tools 1.Considerable experience in the development and application of risk assessment tools for different sources of harm (ionizing radiation, chemicals, etc.); 2.Cooperation with medical research institutes; 3.Development of common approach to HRA methodology for different risk sources including NMs impact, basing on the experience accumulated. Current status (NRC KI) INSC 2014 19-20 February 2014, Tehran

7. 7 Development of risk assessment tools (2) Objects of health risk assessment Analysis’ typeHealth effects Toxicology studyDeterministic effects Health risk assessmentStochastic health effects Deterministic health effects with probabilistic impact source INSC 2014 19-20 February 2014, Tehran

8. 8 Needs in health risk assessment (1)  exclusion of deterministic health effects  limitation of stochastic effects on the reasonably low level (the acceptable risk level). Main principle of establishing health safety standards (HSSs) in different areas of human activity : INSC 2014 19-20 February 2014, Tehran

9. 9 Three levels’ methodology of risk assessment General (common) methods Specific methods Simplified methods Any risk source Specific risk source INSC 2014 19-20 February 2014, Tehran

10. 10 Methodology of health risk assessment (1)  General (common) methods of health risk assessment;  Exposure - response relationships (for a risk source considered) produced in the form of age-cause-specific mortality or morbidity rate; Input data Exposure doses Country or regional health-demographic data Developed specific method INSC 2014 19-20 February 2014, Tehran

11. 11 1.Main (single) task Obtaining exposure-response relationships for impact of nanomaterials from epidemiological studies and medico-biological data. 2. Main problem Non-specificity of health effects, A low statistical power, Latency. Methodology of health risk assessment (2) INSC 2014 19-20 February 2014, Tehran

12. 12 Methodology of health risk assessment (3) The general methods (GM) serves as a basis for development of a specific method, applicable to the corresponding concrete harm source, development and justification of simplified methods. In the last ones, as a rule, averaged risk indices and simplified calculation formulae are used. Justification of applicability of simplified methods can be made only using GM. Necessity of the general methods’ approach INSC 2014 19-20 February 2014, Tehran

13. 13 Methodology of health risk assessment (4) Such structure of HRA methodology in its full development makes specific methods being more transparent, justified and comparable as well as safety decisions on the basis of HRA for different harm sources. Necessity of the general method’s approach INSC 2014 19-20 February 2014, Tehran Necessity of the general method’s approach Two interrelated dimensions of HSSs harmonization  HSSs for different regulated risk sources;  HSSs in different states (with political and economic aspects). The first harmonization can partly serve as a scientific basis for the interstate one’s.

14. 14 General method of health risk assessment (1)  Definitions of: basic quantities, intermediate and main risk indices;  Calculation formulae;  Demands to input data: health-demographic data, exposure - response dependencies;  Uncertainty analysis;  Risks competition;  Single and extended exposures, etc. INSC 2014 19-20 February 2014, Tehran

15. 15 General method of health risk assessment (2) Population age distribution; Age-, cause specific mortality and morbidity background rates; Survival function, Life expectancy for different ages. Basic quantities: INSC 2014 19-20 February 2014, Tehran

16. 16 General method of health risk assessment (3) Individual risk Risk rate (mortality and morbidity); Life-time risk; Life-time damage (LLE); Reduced (relative) risk in all their dependencies (age, …); Population risk : Number of deaths or diseases; Population health damage (LLE); Risk indices (1) INSC 2014 19-20 February 2014, Tehran

17. 17 General method of health risk assessment (4) Generalized and integrated indices (mortality + morbidity, …); Averaged indices (by age and (or) sex ); Standardized indices of mortality or morbidity. Risk indices (2) INSC 2014 19-20 February 2014, Tehran

18. 18 Main conceptual propositions for harmonization of HSSs (1) Risk health safety standards (1)  The general methodology of HRA should be developed to be as the basis for specific (branch) HRA methods;  It is necessary to establish united universal HSSs;  For this establishment the most suitable risk index should be chosen; INSC 2014 19-20 February 2014, Tehran

19. 19 Main conceptual propositions for harmonization of HSSs (2) Risk health safety standards (2)  On the basis of these united universal HSSs the main concrete branch HSSs can be developed in the risk or impact indices;  The proper method of averaging HSSs in age and sex should be chosen. INSC 2014 19-20 February 2014, Tehran

20. 20 Scheme of establishing the harmonized HSSs on the unique risk assessment basis Risk health safety standards (3) United universal HSSs Industrial accidents Ionizing radiation ChemicalsNanotech Bioagents Main branch HSSs Secondary HSSs INSC 2014 19-20 February 2014, Tehran

21. 21 Special risk index  (for comparison and standardization of risks): Risk health safety standards (3)  = “annual exposure” (exposure rate)   damage (LLE) from the exposure unit:  = d  g D Dimension of  : [year (LLE) /year] In the statistical sense  is conditionally a share of the year which is lost due to the exposure to a risk source during this year (conditionally  is a dimensionless quantity) INSC 2014 19-20 February 2014, Tehran

22. 22 Safety regulation (1) Our proposal General health risk limits  п (health safety standards):  п = 0.0004 for public, 0.006 for personnel. The specific, main branch HSSs for different concrete harm sources: d n =  n / g D INSC 2014 19-20 February 2014, Tehran

23. 23 Safety regulation (2) Our proposal  n = 0.0004 public 0.006 workers Industry 1  10 -5 /y public 2  10 -4 /y workers Ioniz. radiation 1 mSv/y public 20 mSv/y workers PM 2.5 1  g/m 3 public 12  g/m 3 workers PM 0.1 0.1  g/m 3 public 1.2  g/m 3 workers Main branch HSSs Secondary HSSs INSC 2014 19-20 February 2014, Tehran

24. 24 Risks comparison Result of comparison in the terms of risk index   4  10 –6 - lightning stroke,  =  7  10 -3 - road accident,   10 -5 - living near NPP. Example of comparison: individual risk INSC 2014 19-20 February 2014, Tehran

25. 25 Results achieved: Conclusion (1)  General methodology of HRA,  Harmonized procedure for standardization of safety standards: specific health risk index for risks standardization and comparison general health safety standards branch health safety standards

26. 26 Helpful possibilities for some NMs: Epidemiological studies’ data on impact effects of fine (2.5 – 0.1  m) and ultrafine (< 0.1  m) PMs from existing publications can be used for producing some ERRs Conclusion (2) INSC 2014 19-20 February 2014, Tehran

27. 27 V.F.Demin, I.E.Zakharchenko. Effects and Paradoxes of Risks’ Competition // Medical radiology and radiation safety. 2011; 56(6): 5 – 14 (in Russian). V.F.Demin, M.V.Zhukovsky, S.I.Ivanov, I.V.Yarmoshenko. Modified Model of Health Risk Assessment from Inhaled Radon // Medical radiology and radiation safety. 2011; 56(5): 21 – 30 (in Russian). Demin V.F., Ivanov S.I., Novikov S.M. Common methodology of health risk assessment for impact of different harm sources // Medical radiology and radiation safety. 2009; 54 (1): 5 – 15 (in Russian). V.F.Demin, M.A.Paltsev, E.A.Chaban. Development of national and international standards of population age distribution for medical statistics, health-demographic analysis and risk assessment. Gigiena i sanitariya. 2013; 6: 14 – 21 (in Russian). Additionally INSC 2014 19-20 February 2014, Tehran

28. 28 V.A.Demin, V.F.Demin, Yu.P.Buzulukov, P.K.Kashkarov and A.D.Levin. Formation of Certified Reference Materials and Standard Measurement Guides for Development of Traceable Measurements of Mass Fractions and Sizes of Nanoparticles in Different Media and Biological Matrixes on the Basis of Gamma Ray and Optical Spectroscopy// Nanotechnologies in Russia, 2013, Vol. 8, Nos. 5–6, pp. 347–356. E.A.Melnik, Yu.P.Buzulukov, V.F.Demin, V.A.Demin, I.V.Gmoshinski, N.V.Tyshko, V.A.Tutelyan. Transfer of Silver Nanoparticles through the Placenta and Breast Milk during in vivo Experiments on Rats // Acta naturae. 2013; V. 5, # 3 (18), P. 45 – 53. V.F.Demin, I.A.Kurachenko, V.Yu.Solov’ev. Concept of harmonization of health safety standards in different areas of human activity // Health risk analysis. 2013; # 3, P. 18-26. Additionally INSC 2014 19-20 February 2014, Tehran