1. Risk Analysis By Dr. Ali Kamil Alsaed, Ph.D. Department of Nutrition & Food Science Faculty of Agriculture University of Jordan akamil@ju.edu.jo

2. 2 Risk Analysis Concepts and Definitions Why Risk Analysis *Food Safety Issues -Foodborne illness -Emerging pathogens -Chemical contamination of food -Microbiological contamination of food -Safety of new technologies -Adequacy consumer protection measures

3. 3 Why Risk Analysis *Adequate Consumer Protection Measures -Reduced levels of inspection and sampling -Increased levels of production -Increased volume of imported food products -Decreased technical competency -Inadequate resources (financial/personnel) -Outdated equipment

4. 4 Why Risk Analysis * Food Control Measures – Traditional Approaches - Factory/cargo inspections - Collection of physical samples - Laboratory analysis of physical sample - Compare results with the established standards - And take necessary action

5. 5 Why Risk Analysis How effective are Inspections How effective is sampling? How effective is the laboratory analysis? How effective in the necessary action?

6. 6 Risk Analysis-History - Has been used for centuries - Information passed from generation to generation - very simple assessment and application mostly involving sensory 'analysis" - evolved to more comprehensive and sophisticated approach for today's problems

7. 7 Risk Analysis-History * Risk analysis used in Western Countries for water, air and soil pollution * Risk analysis used by JFCFA on evaluation of food additives (1958) * Risk analysis used by Codex to establish safety standard for food(1962)

8. 8 Impact Of Recent Trade General Agreement on Tariffs and Trade (GAT) World Trade Organization (1995) International Technical Trade Agreements (Uruguay Round), SPS and TBT Trade Agreements * Agreement on Technical Barriers to Trade (TBT) (Tokyo and Uruguay Round) *Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) (Uruguay Round)

9. 9 TBT Agreement Food Labeling Food Quality Requirements Nutritional Requirements Methods of Laboratory Analysis Methods of Sampling NO RISK ANALYSIS REQUIRFD

10. 10 SPS Agreement Protection of: * Human life and health * Animal life and health * Plant life and health

11. 11 Food Safety (Sanitary Measures) Any measure to protect human life from risks associated with: Food additives Food contaminants Toxins in food Disease carrying or causing organisms Plant and animal carried diseases

12. 12 Animal Sanitary Measures Any measure to protect animal life from risks associated with: * Additives Toxins Pests Diseases Disease causing organisms

13. 13 Phytosanitary Measures *Any measures to protect plant life from risk associated with: -Pests, diseases organism, disease causing organisms *Protects the country or parts of the country from risk associated with: -pests entering, establishing or spreading in the country.

14. 14 What Do SPS Measures Include Laws, decrees, regulations, requirements, procedures and end product criteria Processes and production methods Testing, inspections, certification and approval procedures Statistical methods, risk assessment methods and food safety labeling requirements

15. 15 SPS Rights and Restrictions *The SPS Agreement Recognizes the rights of members to establish appropriate levels of Protection outlines the application of scientific evidence in establishing sanitary / phytosanitary measures Prohibits discriminatory, disguised or unnecessary trade restrictive measures

16. 16 SPS Rights and Restrictions Members are to use Internationally established standards, if they exist, and if they provide the appropriate level of protection. Standard setting bodies Include Codex Alimentarius Commission (food) International office of Epizootics (animals) International Plant Protection Convention

17. 17 SPS Rights and Restrictions Sanitary and Phytosanitary measures which conform to International standards, guidelines and recommendations are deemed necessary to protect human, animal and plant life and are presumed to be consistent with the provisions of the SPS Agreement and of GATT 1994 (Article 3 - 2)

18. 18 Risk Assessment Requirement Members shall ensure that their sanitary and phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risk top human, animal and plant life or health, taking into account risk assessment techniques developed by relevant international organizations. (article 5- 1)

19. 19 Risk Assessment Factors *Factors that can be taken into account include: -scientific evidence -process and production methods -lnspection, sampling and testing procedures *Economic factors that can be considered in animal and plant risk assessment to include: cost of loss in sales or production coat of pest or disease eradication

20. 20 Confusing Terms HAZARD vs RISK What is a HAZARD Biological agents or conditions of food Chemical - Physical * With the potential to cause an adverse health effect

21. 21 What is RISK *RISK A function of the probability of an adverse effect and the severity of that effect, consequential to (resulting from) Hazards in food. Examples of Risk Statement You have a one in 10,000 chance of contracting disease A from eating food in country Z 1/10,000 = yes or 9000/ 10,000 = no *The probability of cancer death from exposure of chemical X at 1 ppm/ day is 6 per 1 million adult population

22. 22 Risk Analysis *What is risk analysis - A dynamic process - An integrated and systematic mechanism of evaluation Risk Analysis consiste of three elements: Risk Assessment Risk Management Risk Communication

23. 23 RISK ASSESSMENT RISK ASSESSMENT- (Basic Steps) Hazard Identification Hazard characterization Exposure Assessment Risk Characterization

24. 24 HAZARD IDENTIFICATION The identification of known or potential health effects associated with a particular agent. Hazard Characterization The qualitative and quantitative evaluation of the nature of the adverse effects associated with the hazardous agents (Chemical, Biological and Physical - Dose Response)

25. 25 FXPOSURE ASSESSMENT FXPOSURE ASSESSMENT is defined as the qualitative and quantitative evaluation of the degree of intake that is likely to occur. Risk Characterization The integration of the: Hazard identification Hazard characterization Exposure assessment Into an estimation of the adverse effects likely to occure in a given population including the attendant uncertainities

26. 26 Risk Management Risk Management is defined as the process of weighing policy alternatives in the light of the results of risk assessment and, If required, selecting and implementing appropriate control options, including regulatory measures. Factors in risk management Risk assessment policy -Guidelines for value judgement and policy choices which may need to bee applied at specific points in the risk assessment process Risk Profile - A description of the food safety problem and its context.

27. 27 Elements of Risk Management Risk evaluation Risk management option assessment Implementation of management decisions Monitoring and review Risk Management Evaluation Identification of a food safety problem Establishing a risk profile Ranking and prioritizing the hazard Establishing policy for conducting assessment Commissioning a risk assessment Considering the risk assessment result

28. 28 Risk Management Option Assessment *Identification of available management options *Selection of preferred management option, including cosidering an appropriate safety standard *Final management decision Implement and monitor risk management decision *Put the decision in operation *Assess the effectiveness of measures taken *Review risk management and/or assessment as necessary

29. 29 3. Risk Communication 3.1. Introduction and Definition Effective communication of information and opinion on risks associated with real or perceived hazards in food is an essential and integral component of the risk analysis process. Regarding the definition, “Risk communication is the exchange of information and opinions concerning risk and risk-related factors among risk assessors, risk managers, consumers and other interested parties.

30. 30 3.2. The goals of risk communication 3.2.1. Promote awareness and understanding of the specific issues under consideration during the risk analysis process by all participates. 3.2.2 Promote consistency and transparency in arriving at and implementing risk management decisions. 3.2.3 Provide a sound basis for understanding the risk management decisions proposed or implemented. 3.2.4. Improve the overall effectiveness and efficiency of the risk analysis process.

31. 31 3.2.5. Contribute to the development and delivery of effective information and education programs, when they are selected as risk management options. 3.2.6. Foster public trust and confidence in the safety of the food supply. 3.2.7. Strengthen the working relationships and mutual respect among all participants. 3.2.8. Promote the appropriate involvement of all interested parties in the risk communication process. 3.2.9. Exchange information on the knowledge, attitudes, values, practices and perceptions of interested parties concerning risks associated with food and related topics.

32. 32 3.3. What is to be communicated? Depending on what is to be communicated and to whom, risk communication messages may contain information on the following: 3.3.1. The nature of the risk - The characteristics and importance of the hazard of concern. - The magnitude and severity of the risk. - The urgency of the situation. - Whether the risk is becoming greater or smaller (trends).

33. 33 - The probability of exposure to the hazard. - The distribution of exposure. - The amount of exposure that constitutes a significant risk. - The nature and size of the population at risk. - Who is at greatest risk.

34. 34 3.3.2. The nature of the benefits - The actual or expected benefits associated with each risk. - Who benefits and in what ways. - Where the balance points is between risks and benefits. - The magnitude and importance of the benefits. - The total benefit to all affected populations combined.

35. 35 3.3.3 Uncertainties in risk assessment - The methods used to assess the risk. - The importance of each of the uncertainties. - The weaknesses of, or inaccuracies in, the available data. - The assumptions on which estimates are based. - The sensitivity of the estimates to changes in assumptions. - The effect of changes in the estimates on risk management decisions.

36. 36 3.3.4. Risk management options - The action(s) taken to control or manage the risk. - The action individuals may take to reduce personal risk. - The justification for choosing a specific risk management option. - The effectiveness of a specific option. - The benefits of a specific option. - The cost of managing the risk, and who pays for it. - The risks that remain after a risk management option are implemented.

37. 37 RISK BASED SYSTEM IN JORDAN Jordan believes that risk management approach is the gateway towards a fair, transparent and merit-based treatment in the International food trade while maintaining science based decisions towards improved Consumer Safety & Quality Protection measures.

38. 38 RISK BASED SYSTEM IN JORDAN CONTENTS INTRODUCTION CONCEPT OF RBS FOOD CATEGORY- CLASSIFICATION&SELECTIVITY CRITERIA AND LEVELS OF INSPECTION INCENTIVE & PENALTY SCHEME IMPLEMENTATION ACTION PLAN RBS- LAUNCHING, AQABA EXPERIMENT AMMAN EXPERIMENT RESULTS & CONCLUSIONS LIST OF ABBREVIATIONS

39. 39 Introduction During negotiations to join the World Trade Organization, Jordan was encouraged to modernize its controls on food and agricultural imports. Jordan's policy of taking samples from 100 % of incoming food shipments for laboratory testing, even when the products posed little or no risk to human health, routinely caused delays of ten days or more. The process also did not systematically monitor results or respond to importer complaints. Upon accession to the WTO, Jordan agreed to bring its food import standards into line with WTO requirements.

40. 40 As part of a broader initiative supporting Jordan's WTO membership, USAID helped implement a computerized, risk-based food safety inspection system at the port of Aqaba, where 25% of food imports enter the country “48% of total consignment weight”. Rather than test every shipment, the system ranks food imports according to the level of threat they pose and tests shipments on a graduated scale - shipments that carry a higher risk are more likely to be tested. In addition, USAID helped design and build the infrastructure for the system and provided equipment and software to create a national database.

41. 41 Risk Based system Concept Monitoring of imported food for compliance with national/international safety and quality standards and other requirements is based upon a risk management approach of control. The system places emphasis on those products determined to be high-risk food products in terms of human health based upon known and potential food hazards associated with these foods. Monitoring of lower risk or no risk food products will be maintained at a surveillance level to assure consistent compliance by importers, shippers and exporting enterprises.

42. 42 This process takes into consideration before the control measures are applied, the nature of the hazards, and the impact on the consumer in terms of severity, which results in a clear idea of what should be examined for which types of hazards based on a priority system associated with the severity of the risk to the consumers. It allows for the allocation of resources to be clearly devoted to the most important areas of consumer protection.

43. 43 It enhances the effectiveness of the control measures by having a predetermined automated plan of what consignment entries will be sampled and what they will be tested for, while not spending scarce resources on entries which have little to no impact on the health of the consumer.

44. 44 Food Categories Classification Foods categories include those of high level of public health risk, those that represent a moderate level of risk and those that represent a low level of risk. High-risk foods will be monitored (sampling and analysis) at the highest level of surveillance, while moderate risk products will be monitored at a lower level of surveillance. Low risk products will be monitored at the lowest level of surveillance.

45. 45 Food items have been classified for Health & Safety Control purposes in three categories based on the possible health risk associated with each food category. As demonstrated below; the first food category includes foodstuff items with the highest risk and exposure to contamination and the third food category includes foodstuff items with the lowest risk and exposure to contamination.

46. 46 High risk food products: Frozen novelties; Dairy and Milk and milk by-products; Fluid and Dried Cheeses from pasteurized milk and Cheeses from un- pasteurized milk Frozen Dairy products; Ice-cream and Processed Eggs; Liquid, Frozen and Dried Products containing eggs; Mayonnaise Bakery; Frozen and Ready to serve (i.e. Bakery & Cakes containing milk & eggs) Yellow Cheeses; Cooked Meat (incl. Poultry) products; Cooked, Dried, Smoked, Salted, Cured and Fermented. Infant cereals, cereal-substitutes & Baby formula

47. 47 Special food products; Dietary purposes Nuts and nut products, Coconut; Flaked and Dried Sesame, Sesame paste (Tahineh) and Peanut butter Raw Vegetables; Pre-cut, Packaged Raw, fresh Vegetables and mushrooms (e.g. tomato, eggplant; Preserved in oil. Low acid foods; Retorted (e.g. Mortadella) Acidified Low acid foods; Aseptic processing, modified atmosphere packaging Low acid foods; preserved and semi-preserved (e.g. Exotic foods) Marine products; Pickled, Spiced and Marinated (salted) Ground raw Meat products (e.g. Sausages and hamburgers) Marine products; Salted, Dried, Smoked, Cured & Fresh chilled, Frozen & Cooked Meat (including Poultry) products; Raw fresh chilled & Frozen – including offal

48. 48 Medium risk food products: Chocolate; primary manufacture (from cocoa beans) Bakery products; Ready to serve (i.e. not containing milk & eggs as dried crumbs) Mineral, spring water; Bottled and Malt beverages Chocolate (including all types) and Cocoa and cocoa derivatives Milk and milk by-products; Liquid Condensed and Evaporated Jams and Sugar Confectionary (i.e. Candies, Ha’loum and Halawa) Food Supplements and Frozen novelties (non-dairy) Coffee whiteners, whips and creams Fruits fresh; Processed or Dried Vegetables; Fresh, Dehydrated and Dried

49. 49 Spices and Soups; Dried and Yeast and bacterial cultures Mixes and bases; Dried (e.g. Cake mixes, Jelly, Custard and Caramel) Eggs in shell (table serve) and Butter Fillings and Toppings and Gelatine desserts and puddings; Dried Flour and Starch, Chips and Breakfast cereals (e.g. Corn flakes) High Acid foods; Retorted or hot filled or Aseptic processing (e.g. Ketchup & Mustard) Biscuits, Wafers and Cakes and Chewing gum (all types) Fruit Juices and Concentrates and Fruits; Dried (e.g. Dates and dry figs)

50. 50 Low risk food products: Carbonated Beverages Coffee and Tea (all types and shapes) Dairy products; Jameed Sugar and sugar syrups, Honey and black honey and Molasses Oils, Fats, Margarine and Butter blends Fruits; Fresh and Frozen Grains and grain derivatives (except flour) Salt and Vinegar Vegetables; Frozen and Beans Pasta, spaghetti and couscous Dried Herbs (e.g. mint & oregano) In cases where an imported food item is not listed in the above food categories, it shall be treated as a food item falling in the high risk category until a final classification is determined.

51. 51 Selectivity Criteria and Levels of Inspection

52. 52 Selectivity Criteria and Levels of Inspection Despite what has been stated concerning levels of inspection and sampling collection based on food categories, an additional 10% of all food consignments shall be subject to inspection via the Random electronic method, whereby sample collection for laboratory analysis from such consignments will be left for the decision of the “Inspection and Sampling Committee” based on the sensory inspection results. Pertaining to banned food that have been officially declared prohibited by Ministry of Health, Ministry of Agriculture or Jordanian Institute for Standards and Metrology to enter Jordan will neither be inspected nor samples collected for consignment. Banned Foods Automatically Detained food:

53. 53 Foodstuff items with evidence to continuous non- compliance with health and safety requirements Foodstuff items entering Jordan for the first time; where consignments will be subject to inspection and laboratory analysis for five successive shipments, and in case they were found in compliance with health and safety requirements, the detention will be lifted and foodstuffs will be subject to the regular risk-based food control inspection levels. Foodstuff items rejected from other countries. Foodstuff items that have been notified upon by other countries or related international organizations. Clearance of such foodstuff items will be carried out only after compliance with conditions of document review, inspection and laboratory analysis results stating fitness for human consumption.

54. 54 Incentives and Penalty scheme Incentives for foodstuff consignments in compliance with health & safety requirements: In cases where five successive foodstuff shipments for the same food item classified in first, second or third category and obtained from the same manufacturer/source and have proved compliancy with health and safety requirements after being inspected and having passed laboratory analysis, then; –All foodstuff consignments shall be subject to inspection. –Sample collection for laboratory analysis purposes will be carried out on one consignment out of four consignments which have been inspected. –Same foodstuff item obtained from same manufacturer/source shall be given such benefit as long as it complies with health & safety requirements. Where a foodstuff consignment was not found to be in compliance with health and safety requirements, then benefits given shall be withdrawn and the consignment will be subject to the regular risk- based food control inspection levels until evidence of compliance is proved for the next successive five shipments.

55. 55 Implementation Action Plan The risk–based food control system has been discussed and investigated thoroughly among all related national line authorities since September 2000 where the final approval of the system was issued by the National Food Council in 2001. The implementation plan was covering the following main themes: Issue the first Food Law of Jordan which will adapt to the new system concept on December 2001, All the regular institutions “JFDA, JISM, MoH, MoA, Great Amman Municipality...” and their roles are described in the form of acts, regulations and codes of practice.

56. 56 Construction of a refrigerated inspection food centre for reefer shipments examination and portion sample collection with suitable transportation vehicles to the food laboratory, where it was launched on Nov. 2002 and has been able to host approx. 40% of the actual reefer containers. Renovation of sample office space for the food clearance center to serve all related national agency officials with required logistics at the Port zone where channeling, document review and all other paper procedures take place.

57. 57 Provide necessary portion field sampling equipment with practical training sessions and introducing the sampling number code concept. Unifying and harmonizing the health certificates required submission on port of entry according to food groups and Introducing a new concept of third party accredited single Health Certificate and E- certificate approval as beginning of year 2003.

58. 58 Revising and updating some of the national standards and regulations; i.e. Shelf life standards, sample size as well as the temperature for reefer cargos regulations. Develop a systematic unified form for the clearance procedures of all imported food consignments to be filled out by national line agency representatives.

59. 59 Develop risk channeling protocol with the associated food groups electronically utilizing tools of ASYCUDA software. Thus, enabling importer agents to file the entry forms electronically to be further assessed throughout the clearance procedures. Design and structure a database archiving system that captures all import data, certificates, test analysis results with statistical tools to enable data analysis for a solid based risk management system, providing sets of reports on various parameters.

60. 60 RBS- Launching Recognizing Jordan’s limited financial resources to undertake a full lengthy risk assessment, instead, a thorough benchmarking study was carried out referencing to various international organization researches and government risk assessments. The literature was studied by a national specialized team “MoH, ASEZA, MoA, JISM, University of Jordan”, designed and structured with some refinements based on practical experience, climatic and further cautious criteria to acquire public acceptance

61. 61 Criteria based on the public health risk associated with various foods or other compliance or procedural factors were utilized to select food entries for appropriate monitoring, where food products have been categorized into three groups; High, Medium and Low–risk groups. Approximately 90% of imported food inter Jordan via Amman custom and Aqaba port, The risk based imported food control system was officially launched at Aqaba port of entry on 20th May 2002 and extended to Amman Borders of entry on 1st Jan 2004.

62. 62 RBS- Jordan Aqaba Experiment Control is exercised electronically through the computerized Selectivity Module of the Automated System for Custom Data (ASYCUDA) which was massaged into a closed cycle to adapt food categories and their selectivity criteria. Food entries entered into the ASYCUDA system are identified by their Harmonized system “HS code” for clear and accurate management by food control officials and importers throughout the clearance procedures. Effective on 5/2002, rev.2003, 2006. For archiving and tracking purposes, a Food Import Management Information System (FIMIS) was engineered, successfully on September 2002.

63. 63 An information archive base to assist the Food officials in identifying trends and analyzing statistical data, regarding the safety of imported food products arriving through the Aqaba port for Jordan. Developments of a new risk-based management system for conducting post audit and inspection activities on the food sector outlets in the Aqaba Special Economic Zone (ASEZA) RBS- Jordan 2007, The risk-based management system, recently developed and implemented by the ASEZA, classified food activities according to their associated food hazards and was interrelated with their actual inspection scoring grades in order to determine the scheduled frequency of inspection visits. The system would be fully automated and linked to GIS electronic maps and traceable databank, utilizing mobile devices and radioconnection.

64. 64 RBS- Jordan Amman Experiment Amman Custom- 1/1/2004 Total No. of consignments 65%, “48% of consignments’ weight” Same procedure of Aqaba, is adopted for Imported food. For archiving and tracking purposes, a Food Import Management Information System (FIMIS) on process to be engineered. The system will provide information useful in communicating and coordinating Jordanian activities with international efforts to improve the overall safety and quality of food trade. The system is adopted as strategic plan for food control. Activate Risk Analysis Communication division. “Centrally Coordinating Monitoring Programme” is launched at 6/2007 for domestic food products, based on the principles of RBS.

65. 65 Results and Conclusions Jordan now has a national database for food imports, allowing authorities to constantly update and improve risk analysis and cooperates with international efforts to improve regional food safety. The risk-based system is a key to creating a fair, transparent and equitable trade environment. General conclusion is that, with the implementation of such a risk management approach for imported food control program, Jordan was able to:

66. 66 Decrease by about 50% of redundant sampling and test analysis Drop the amount of bulk samples into reasonable portions to fit the lab analyses Reduce timeframes required for clearance of imported food consignments Resources oriented towards enhancing inspection methodologies and proper field cargo examination, portion sampling and more thorough laboratory tests to assess the safety and quality of imported foods

67. 67 Establish the first electronic national database information system to build a strong data collection, tracking records, well analyzed trends, enhanced reporting and notification with equal incentive-penalty program based on merit Systemize transparent clearance procedures where stakeholders acknowledge their responsibility and accountability Build a model for the region that can assist many developing countries to reach a risk management control approach with fairly reasonable resource allocation corresponding with globalization requisites