1. Module 4 Risk Management and Developing a Food Standard

2. 2 4A. Identifying the need for a food regulatory measure ● The legal framework, criteria for assessing standards and acceptable levels of risk ● Developing a risk profile ● Identifying risks ● risk assessment policy and acceptable levels of risk ● Categorizing and evaluating the risks

3. 3 Legal framework to develop and implement standards Organisational structures ● Multiple agency, ● Single agency ● Integrated ● Legislative backing ● Prescribed process ● Matters to be considered ● What can be in a standard

4. 4 Food Standards making processes ● Objectives: ● Protect public health and safety ● Promote fair trade ● Prevent deception ● International trade harmonisation ● Use risk analysis based on sound science ● Transparency/Consultation ● Triggers to initiate standards setting

5. 5 Food Regulatory Measures ● Standards ● Mandatory ● Codes of practice ● Mandatory or advisory ● Guidelines ● Codex – advisory http://www.codexalimentarius.net/we b/procedural_manual.jsp

6. 6 Triggers for food standards making? ● outbreak of food-borne illness ● microbiological, or chemical ● potential new chemical hazard ● contaminant analysed in food ● pesticide or agricultural chemical residue ● new chemical registered ● residue found in imported food ● new food additive registere

7. 7 Triggers for food standards making? ● alignment with Codex / trading partner standard ● support consumer confidence in food supply

8. 8 Develop Risk Assessment Policy ● Sets guidelines for value judgements and policy choices during risk assessment, eg ● Identify population(s) at risk, ● criteria for ranking hazards, ● acceptable levels of risk, safety factors. ● Developed by risk managers working with risk assessors ● Use of ADI, NOEL, GAP, GMP etc

9. 9 Set Appropriate Levels of Protection ● Risk assessment ● #1 protect human health ● “Other factors” are risk management ● (e.g. economic costs/ benefits, technical feasibility, societal preferences) ● WTO SPS ● Consistency across foods ● Equivalence in food safety measures, regulatory objectives and the levels of protection. ● Scientifically supported

10. 10 Risks - likelihood and consequences (1) ● Health risks ● food-borne illness outbreaks, ● Economic risks ● reputation for quality production ● access to domestic and export markets ● Social risks ● consumers mislead, lose confidence in ● products/ producers ● Government/regulators ● Ethical choices ● Halal, vegetarian

11. 11 Risks - likelihood and consequences (2) ● Probability of risk occurring ● Consequence if risk occur Likely / Not serious Rare/ Not serious Likely / Catastrophic Rare / Catastrophic

12. 12 Risk prioritisation example - Codex ● CCFAC ● Criteria for inclusion in the General Standard for Contaminants and Toxins ● Identification of the problem. ● toxicological, analytical and intake data available. ● Indications about (potential) health problems. ● Existing and expected barriers to international trade. ● technological possibilities and economic aspects for management of the problem in food.

13. 13 Risk Management & Food Standards Exercise 4A ● In Working groups ● FAO Case studies ● Examine one of the case studies ● Identify associated risks ● Propose appropriate levels of protection for the hazards at a national level ● Report back and class discussion.

14. 14 4B Community Involvement & Consultation ● Preliminary consultation ● Why consult? ● Identifying stakeholders? ● How to consult ● (information, timelines and resources) ● A two way process!

15. 15 Risk Communication "an interactive exchange of information and opinions concerning risk and risk related factors among risk assessors, risk managers, consumers and other interested parties"

16. 16 Why Consult? (1) 1. Awareness and understanding of issues and risk management decisions 2. Consistency and transparency in risk management decisions; 3. Improved effectiveness and efficiency of risk analysis process;

17. 17 Why Consult? (2) 1. Public trust and confidence in the safety of the food supply; 2. Involvement of interested parties in the risk communication process.

18. 18 Stakeholders ● Government ● Industry ● Consumers ● Public Health Professionals ● Trading Partners ● WTO notification ● bilateral partners

19. 19 Consultation – Information (1) 1. The nature of the risks and benefits ● Health, economic, social, scientific and ethical ● The urgency of the situation. ● Is the risk is becoming greater or smaller ● The nature and size of the population at risk. ● Potential benefits associated with each risk. ● Who benefits and in what ways. ● How risks and benefits will be balanced ● A request for relevant data (scientific, economic, social)

20. 20 Consultation – Information (2) 1. Uncertainties in risk assessment ● The methods to be used used to assess the risk. ● The background to the regulatory policy and its assumptions 2. Risk management options ● The potential action(s) that may be taken to control or manage the risk(s).

21. 21 Consultation – How (1) ● Expert/Stakeholder panel ● Risk Assessor and Managers present directly to panel ● Can be standing committee or Ad Hoc ● Rapid response but least transparent ● Resource cost low (but may have to pay sitting fees). ● May have lower community acceptance

22. 22 Consultation – How (2) ● Targeted consultation ● Issues paper prepared by Risk Assessors/ Managers. ● Circulate to specific stakeholder groups, eg ● industry associations, consumer organisations and professional bodies. ● Good for rapid response or highly technical issues. ● May be resource intensive to evaluate responses.

23. 23 Consultation – How (3) ● Direct public consultation ● Issues paper prepared by Risk Assessors/ Managers. ● Public advertising or issue & call for comment ● Broadest reach / Most transparent ● May be resource intensive to evaluate responses ● Longest timelines

24. 24 Risk Management & Food Standards Exercise 4B ● In Working groups ● FAO Case studies ● Within a national context, prepare a communication plan for one of the FAO case studies. ● Report back and class discussion.

25. 25 4C. Considering issues: scientific, regulatory, international obligations ● What does the science say? ● Risk assessment – source, output ● (risk characterisation) ● Risk management strategies. ● What are the international obligations ● Codex or other relevant Intl. Std? ● Supported by science? ● Is it acceptable? ● Regional, local issues?

26. 26 Risk Assessment Sources ● FAO/WHO – Codex – JECFA, JMPR, JEMRA? ● Regional national bodies – EU (EFSA), FSANZ – USFDA, Health Canada ● National exposure data – Consumption, production etc.

27. 27 Understanding risk characterisation ● Chemical – ADI, PTWI/PMDI, ALARA – Uncertainty, safety factors – Human data? ● Biological – quantitative output rare – qualitative estimate of the potential for adverse effects from the particular bacterial agent on a specific population.

28. 28 Risk Management Strategy ● #1 Protection of human health ● Describes how food safety risks and other factors are balanced – economic costs, benefits, technical feasibility, and societal preferences ● Use to identify possible regulatory measures (including standards) to address identified risk.

29. 29 Risk Management Strategy ● Codex – General Standard for Contaminants and Toxins – MLs only set where : ● Contaminants present risk to public safety ● Foods significant to total contaminant exposure ● Levels as low are reasonably achievable considering GAP/GMP and can be analysed ● Sufficient data is available ● The food moves in international trade.

30. 30 Is there a Codex Standard? ● Recognised in WTO SPS agreement ● Is standard relevant/ acceptable? – compare the options to meet risk management policy with identified international standards ● Is a Regional / Local variation necessary? – Higher level of protection will require justification

31. 31 Risk Management & Food Standards Exercise 4C ● In Working groups ● FAO Case studies ● For one of the case studies, develop a risk management strategy ● identify possible national RM options. ● Codex standard ● Is there a relevant Codex Standard? ● does the standards address national issues? ● Report back and class discussion.

32. 32 4D Options and regulatory impacts ● What are the regulatory options? ● Regulatory impact assessment

33. 33 Regulatory Options ● may include: – do nothing (ie do not make a regulatory measure) – make a voluntary measure eg guideline or code of practice. – make a standard ● what sort of standard? ● consider the options including any international standards

34. 34 Regulatory Options - Standards ● May be generic or commodity based: ● May include: – identification of the hazard (ie the chemical or biological agent), a specific food or foods, – conditions of production, processing, storage, handling or preparation, – quantitative limits and or reference to GMP, GAP, GVP.

35. 35 Regulatory Options – Codex GSFA ● Additives with – JECFA “ADI not specified” - GMP in all foods except exempt food list – JECFA Numerical ADI – approved in named food categories normally with max level – No JECFA ADI – not permitted – Processing Aids - listed in inventory – not included in a standard.

36. 36 Regulatory Impact Assessment ● A decision making tool. ● Systematic examination of potential impacts on stakeholders (ie govt., industry and consumers). ● Helps risk managers (and regulatory authorities) make sound decisions.

37. 37 RIA - elements 1.Nature and magnitude of the problem and the need for regulatory action; 2.Summary of the risk assessment policy and the acceptable levels of risk 3.Summary of the risk assessment outcomes, the consultation undertaken and of the consideration of relevant issues by risk managers; 4.List of potential regulatory measures identified to address the risks, including relevant international standards.

38. 38 RIA – elements (cont.) 1.For each of the options identified: – a statement of the benefits and costs for each stakeholder group, including administrative, compliance, and economic benefits and costs. Where possible these should be quantified. Non-quantifiable benefits and costs should also be included and identified appropriately; 2.Identify the preferred regulatory option(s)

39. 39 Regulatory Impact Assessment ● Government: – Relative costs of inspection and enforcement; – Reduced health service costs arising from a safer food supply; – Political costs/benefits of a safe food supply.

40. 40 Regulatory Impact Assessment ● Consumers – Better access to safe affordable food and better nutrition / food choices; – Increased cost of food (passed on from food manufacturers); – Reduced incidence of food-borne illness.

41. 41 Regulatory Impact Assessment ● Industry – Direct costs of compliance; ● Introduction of HACCP/quality management systems, ● Changes to process., ● Changes to packaging/labelling. – Benefits ● increased access to export markets, ● increased sales.

42. 42 Risk Management & Food Standards Exercise 4D ● In Working groups ● FAO Case studies ● Within a national context prepare a RIA for one of te case studies ● Report back and class discussion.

43. 43 4E. Drafting a standard Preparing drafting instructions for general admin staff or legal professionals? The anatomy of a food standard

44. 44 Drafting a Standard ● include identification of: – the legislation under which the standard(s) will be implemented; – the aims and objectives of the standard; – the criteria to be addressed in the standard (eg the identity of the hazard, maximum levels, foods concerned) – any other relevant information to te operation of the standard.

45. 45 Drafting instructions - Codex ● A Codex standard may be implemented by: a) a reference in national legislation to the Codex standard text, ● Static or progressively updating b) Reproduction of the Codex text in national legislation, c) drafting a standard in a format appropriate to national legislation which implements the relevant elements of the Codex standard.

46. 46 5F. Notifying stakeholders about the proposed standard and undertaking further consultation ● Why consult on a draft standard? ● Elements of effective risk communication

47. 47 Why consult on a draft standard? ● stakeholders understand issues and risk management decisions; ● consistency and transparency; ● Effectiveness of the proposed regulatory option; ● public trust and confidence in food safety; ● Involvement of interested parties in the standards setting process.

48. 48 Effective risk communication ● The nature of the risk ● the other factors considered ● Risk management options considered ● The justification for preferred risk management option ● the Regulatory Impact Assessment (RIA).

49. 49 Risk Management & Food Standards Exercise 4F ● In Working groups 1. For one of the FAO risk assessment case studies; ● identify affected stakeholders ● prepare a list of key items to be included in feedback to consumers, 2. report back and class discussion.

50. 50 4G. Analysing issues and revising standards ● Consider stakeholder submissions – Generic about risk analysis and assumptions – Specific to hazards and/or the risks ● Monitoring and review

51. 51 Monitoring and review ● Central reporting of routine surveillance ● Central reporting of food-borne illness ● Specific surveys – food specific – consumer specific ● Need for objective measures against which a standard can be measured.

52. 52 4H. Final decision making (legislative process or other political consideration) ● Standards sould be adopted into legislation by appropriate political means ● Publication in govt. Gazette or other official journal to inform te community

53. 53 5H. Final decision making ● Implement according to the urgency determined during the risk analysis: – urgent public health and safety concern, or relax regulations or permit new ingredients may commence upon gazetteer. – Mandatory changes to food formulations or labelling - allow the food industry and importers reasonable time (1-2 years) to implement the changes in their product.

54. 54 Risk Management and Standard Setting - Summary A)Need for food regulatory measure B)Community consultation C)Consider issues: scientific, regulatory, international obligations D)Options and regulatory impacts E)Drafting a standard F)Notify stakeholders of proposed standard and undertaking further consultation G)Analyse issues and revise standard H)Final decision making & implementation