2. The Concept and Use of Risk Analysis in Food Safety Jeronimas Maskeliunas MD, PhD Secretariat, Codex Alimentarius Commission Food and Nutrition Division, FAO of the United Nations Almaty, 13-18 October2002

3. The Concept and Use of Risk Analysis in Food Safety * 1. Concept and Use of Risk Analysis in Codex 1991 - 2002 * 2. Conclusions

4. Risk analysis - new concept? Risk and Codex

5. Risk Analysis-New Concept? Risk analysis existed for over a century and was widely used in such diverse areas as: * insurance * investment * engineering

6. Risk Analysis Risk analysis was not designed to provide a decision Instead it was tool to support decision - making

7. FACT In most countries the decision concerning whether a risk was acceptable and what would be done to reduce or eliminate risk was and is taken at a political level

8. FACT Risk is composed of two main elements: * the probability or likelihood of an adverse effect occuring * magnitude of the consequences

9. Classical example: In walking across the street the probability of being hit by: a pedestrian; bicycle or car could be the same however consequences would be very different

10. FACT * Everyone faces potential hazards and risks every day * Hazards and risks are natural part of life

11. Why do we need to do risk assessment? Risk and Codex

12. Science and Risk in Codex * All Codex Committees should continue to base their evaluations on suitable scientific principles * The CAC and its relevant Committees …. should make explicit the methods they have used to assess risk Joint FAO/WHO Conference on Food Standards, Chemicals in Food and Food Trade, Rome, 1991

13. Risk Analysis and Codex * 1991 yCAC accepted the Conference Recommendation

14. Risk Analysis and Codex * 1993 yCAC approved the use of risk analysis in Codex work

15. Risk Analysis and Codex * The decisions of the Codex in 1991 and 1993 to base its work on risk analysis predated the WTO SPS Agreement of 1995

16. The SPS Agreement Article 5.1 * Members shall ensure that their sanitary and phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life and health, taking into account risk assessment techniques developed by the relevant international organizations

17. The SPS Agreement Article 5.2 * In the assessment of risks, Members shall take into account available scientific evidence; relevant process and production methods; relevant inspection, sampling and testing methods; prevalence of specific diseases or pests; existence of pest- or disease-free areas; relevant ecological conditions; and quarantine or other treatment.

18. FACT * Countries may introduce or maintain different standards (measures), based on scientific justification or use a higher level of protection (Article 2.3) * The scientific justification must be based on a risk assessment (Article 2.3 and Article 5)

19. Note *Food safety measures that conform to the standards elaborated by the Codex Alimentarius Commission are presumed to be consistent with the WTO’s SPS Agreement *This means that no further risk assessment is required: Codex has already provided it

20. Codex Alimentarius Commission and Risk Analysis *Statements of Principle Concerning the Role of Science in the Codex Decision Making Process and the Extent to Which Other Factors Are Taken Into Account *Statements of Principle Relating to the Role of Food Safety Risk Assessment *Definitions of Risk Analysis Terms Related to Food Safety

21. Definitions of Risk Analysis Terms Related to Food Safety *Hazard *Risk *Risk Analysis *Risk Assessment *Hazard Identification *Hazard Characterization * Dose-Response Assessment * Exposure Assessment * Risk Characterization * Risk Management * Risk Communication

22. Concept of Risk Analysis Risk Analysis: A process consisting of three components: z risk assessment, z risk management and z risk communication

23. Concept of Risk Analysis Risk Assessment: A scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization

24. Principles and Guidelines for the Conduct of MRA - 1999 *Definitions of relevant terminology *General principles ysound science, structured approach, interaction with RM, statement of purpose, transparency, constraints, uncertainty, reality check, review *Guidelines for application

25. Hazard Identification * Physical * Chemical * Biological

26. Hazards * Physical: *stones, *metal pieces in flour or bread

27. Hazards * Biological Pathogenic bacteria (>80% of outbreaks) Moulds (Mycotoxins) Viruses (Hepatitis A) Parasites (Trichinella; Toxoplasma)

28. Hazards * Chemical Natural: numerous toxins (mycotoxins, Phycotoxins; Saponins; Vicine in fava beans; cyanogenic glycosides; tannins; Gossypol; etc…) Industrial: PCBs, Dioxins; Heavy metals Agricultural: Pesticides; Fertilizers

29. Hazards * Chemical (cont.) Veterinary: animal drug residues Food additives: Colours, flavours, preservatives, emulsifiers, thickening agents, etc.. Processing aids: (extraction solvents) Packaging materials: plastic monomers

30. Hazard Characterization *Qualify and/or quantify the nature and adverse health effects associated with hazards in food. *For chemical hazards a dose- response assessment should be performed

31. Note that: *Results of hazard chacterization (ADI, PTWI, etc) are valid for all populations *Diet variations and other population variations are built into the safety factors

32. Exposure Assessment * Quantitative or qualitative evaluation of the likely intake of hazards via food, water as well as exposures from other sources, if relevant

33. Exposure Assessment *Limitations at the international level *Certain data available only at the national level *Data more accurately reflecting the reality are available at the national level

34. Characterize risk * In order to determine the severity of potential health effects - the results of the exposure assessment should be compared with the toxicological endpoints recommended by JEXFA/JMPR

35. Risk Characterization *Use ADIs, PTDIs/PTWIs, Acute RfDs recommended by JECFA/JMPR or other international/regional bodies *Use proposed evaluations by JECFA/JMPR *Regional cooperation

36. Microbiological hazards vs chemical hazards Microbiological hazards zpathogen-commodity combination zsingle exposure zindependent non- cumulative event zvariable response znumbers can change up or down zdynamic and adaptable - different characteristics Chemical hazards z one chemical - many foods z multiple exposures z cumulative effect z toxic levels stable or decrease during storage z no dramatic change in toxicity

37. Definitions of Risk Analysis Terms Related to Food Safety (continued) Risk Management: The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options

38. Definitions of Risk Analysis Terms Related to Food Safety (continued) Risk Communication: The interactive exchange of information and opinions throughout the risk analysis process concerning hazards and risks, risk- related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions

39. Principles of risk analysis *soundly based on science, consistent, open and transparent *fully and systematically documented in a transparent manner *functional separation of risk assessment and risk management *situations of developing countries should be specifically identified and taken into account

40. Principles of risk analysis *precaution is an essential element of risk analysis lwhen there is evidence that a risk to human health exists but scientific data are insufficient or incomplete, Codex does not proceed to elaborate a standard but considers elaborating a related text, such as a code of practice, provided that such a text would be supported by the available scientific evidence

41. Hazard Analysis vs Risk Analysis * Hazard Analysis deals with hazards that you can measure in food typically is quantitative carried out at company level processing plant/commodity specific

42. Risk Analysis * typically is qualitative * carried out by governments and/or regulatory institutions * focuses on the control of an industry-wide public health problem (e.g. listeriosis in ready- to-eat foods)

43. Risk Analysis * outcome is quantitative or qualitative estimate of the likelihood of and adverse consequence due to exposure to a hazard to one or more populations, the development of one or more options to manage risk, and the development of recommendations to communicate the management of the risk to consumer

44. Risk analysis should * Identify hazards * Characterize risks * Recognize uncertainty * Summarize conclusions * Recommend options * Document the basis for decisions

45. CAC 1999 *Programmes that contribute to risk analysis should have high priority *Relevant Codex committees should continue to develop and apply risk analysis principles and methodologies appropriate to their specific mandates *Risk management should take into account the economic consequences and the feasibility of risk management options in developing countries

46. Risk Analysis and Codex * December 1999 onwards yFAO/WHO Programme of activities on microbiological risk assessment convened in response to request from CAC / CCFH

47. FAO/WHO Risk assessment EC zSalmonella spp in broiler chickens and eggs zListeria monocytogenes in ready to eat foods zCampylobacter spp. in broiler chickens z Vibrio spp. in seafood

48. Outputs *Risk assessment monographs *Interpretative summaries *Guidelines documents zhazard characterization zexposure assessment zrisk characterization

49. Where to put intellectual and financial resources? Risk and Codex

50. Risk assessment *Principles and methodology of risk assessment are equally valid for all countries z No need to put resources there

51. * Surveillance infrastructure weak or non-existent; * Different reporting systems; * Information kept secret sometimes; * Lack of resources and programmes for this purpose; Constraints in data collection

52. Data availability - current limitations *data not collected or generated *unpublished and not available by other means *confidential *not available in a format useful for risk assessment

53. Data availability - current limitations *insufficient information for example on how it was generated *not comparable due to use of different methodologies in collecting or generating data  not aware of all the data sources

54. Sources of data *National surveillance data *Epidemiological surveys *Industrial surveys *Research publications *Unpublished research work *Government reports *Food analyses data - import / export, food control sampling

55. Техническая помощь FAO странам-членам : * FAO Technical Cooperation Programme * Regional and National Seminars, Workshops on Risk Analysis * Projects to generate the necessary data

56. Conclusions Risk assessment

57. Conclusions The introduction of risk analysis as a discipline in standardization has opened new possibilities for international harmonization

58. Conclusions *The concept can be extended further to establish conditions for determining the equivalence of measures or systems designed to address risk

59. Conclusions * Countries can compare their standards, codes and other measures to determine if they are equivalent to internationally accepted standards or the standards of their trading partners

60. Conclusions *Scientific analysis of potential hazards has proved to be a firm basis for decision-making in the management of food safety risks *Scientific evidence is not sufficient in itself for the establishment of risk management measures

61. Conclusions *other legitimate factors need to be taken into account, but ythey need to be well documented yshould not affect the scientific process yare not an alternative to the scientific process

62. Conclusions * Use scientific data provided by JECFA, JMPR, FAO/WHO Expert Consultations *Adopt and/or use Codex risk based standards, MRLs, codes of practice, guidelines etc - save resources * Prioritise areas of work and available funds

63. Contact ! Joint FAO/WHO Food Standards Programme Food and Nutrition Division, FAO Viale delle Terme di Caracalla 00100 Rome, Italy Fax +39 (06) 5705.4593 E-mail : codex@fao.org

64. Visit Our Website zHttp://www.codexalimentarius.net zJECFA Related Information yhttp://www.who.int/pcs/JECFA/jecfa.htm zJMPR Related Information yhttp://www.who.int/pcs/JMPR/JMPR.htm zExpert Consultation Reports yhttp://www.fao.org/WAICENT/FAOINFO/EC ONOMIC/ESN/expertfq.htm

65. Thank you very much for your kind attention and wish all success!