Sources of Information and Available Tools for Conducting Risk Assessments

Transcription

1 Sources of Information and Available Tools for Conducting Risk Assessments Alejandro Amézquita, PhD Safety & Environmental Assurance Centre, Unilever June 18, 2014

2 Outline» International Resources (Codex, FAO, WHO, ICMSF)» Regional Resources (European Commission, EFSA, ILSI- Europe)» Resources at FoodRisk.org (USA-based)» Other Resources

3 (Inter)national organisations involved in the development of risk assessment principles and methods Health Canada

4 Risk Analysis = the common framework Risk Analysis:» Risk Management» Risk Assessment» Risk Communication RA Triggered by World Trade Organisation (WTO) Advocated by many governments and intergovernmental organisations (FAO, WHO) FSO/PO HACCP GHPs/GMPs/GAPs

5 Codex Alimentarius RA Framework Risk Assessment Hazard Identification Hazard Characterisation Exposure Assessment Risk Characterisation Risk Management Risk Evaluation Option Assessment Option Implementation Monitoring & Review Risk Communication Interactive exchange of information and opinions concerning risks

6 Codex Alimentarius RA Framework Risk Assessment Science Based Risk Management Policy Based Risk Communication

7 Example: risk-based approach for evaluating toxicological safety of ingredients Product type Ingredient level Toxicology data Consumer habits Frequency of use Amount of product 1. Hazard identification Safe history of use Human data Route of exposure 3. Exposure assessment 2. Hazard characterisation Computationa l Chemistry Retention factor Biological equivalence 4. Risk characterisation Overall safety evaluation define acceptability and risk management measures 7

8 Responsibilities for risk management and for risk assessment at the international level CODEX ALIMENTARIUS COMMISSION FAO/WHO PROGRAMME FOR THE PROVISION OF SCIENTIFIC ADVICE

9 Providers of scientific advice Chemical JEFCA JEMRA Micro JMPR Ad hoc consultations biotechnology probiotics micronutrients etc..

10 Resources from Codex, FAO, WHO Meeting reports Technical reports» Risk assessments» Monographs for specific chemical in foods» Toxicological evaluations Summary reports» Rapid information dissemination» Focussed more towards risk managers and less technical readers

11 JEMRA OUTPUT MRA reports how to guidelines Guidelines on principles/process

12 JEMRA OUTPUT: CCFH use:

13 Microbiological Risk Assessments» Microbiological hazards associated with fresh produce» Viruses in foods» Enterohaemorrhagic Escherichia coli (EHEC) in meat and meat products» Salmonella in eggs and broiler chickens» Listeria monocytogenes in ready-to-eat foods» Vibrio spp. in seafoods» Campylobacter spp. in broiler chickens» Enterobacter sakazakii and other microorganisms in powdered infant formula» Foodborne parasites Today

14 FAO/WHO MRAs Listeria monocytogenes in ready-to-eat food Cronobacter spp (E. sakazakii) in infant formula Vibrio spp. in seafood Salmonella spp. in broiler chickens and eggs Campylobacter spp. in broiler chickens Codex guidelines General principles of food hygiene for management of L. monocytogenes Recommended international code of practice for foods for infants and children Risk management strategies for Vibrio spp. in seafood Risk management strategies for Salmonella and Campylobacter in poultry

15 Scientific advice Technology transfer

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24 JEMRA Resources

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27 Technical Report Series (TRS) Food Additive Series (FAS)

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31 For more information Codex web site: FAO food safety and quality website: WHO food safety website:

32 Resources from ICMSF publications (papers, books) Software tools lay-man guides

33 Resources from ICMSF Peer-reviewed publications Validation of control measures in a food chain using the FSO concept. Food Control, Volume 21, Issue 12, Supplement, December 2010, Pages » Relating microbiological criteria to food safety objectives and performance objectives. Food Control, Volume 20, Issue 11, November 2009, Pages » Use of epidemiologic data to measure the impact of food safety control programs. Food Control, Volume 17, Issue 10, October 2006, Pages

34 Resources from ICMSF Peer-reviewed publications Principles for the establishment of microbiological food safety objectives and related control measures. Food Control, 9(6): (1998).» Potential application of risk assessment techniques to microbiological issues related to international trade in food and food products. J. Food Protection, 61(8): (1998).» Establishment of microbiological safety criteria for foods in international trade. Wld. Hlth. Statist. Quart., 50: (1997).» Choice of sampling plan and criteria for Listeria monocytogenes. Int. J. Food Microbiol.22:89-96 (1994)

35 Resources from ICMSF Discussion/opinion papers for Codex Alimentarius» Principles for the establishment and application of microbiological criteria for foods (case studies for application of MCs; 2012)» Use of Epidemiologic Data to Measure the Impact of Food Safety Control Programs (2005)» Microbiological criteria for powdered infant formula (2005)» The role of Food Safety Objectives in the management of the microbiological safety of food (2001)» Sampling plans for microbiological safety criteria for foods in international trade (1996)» Principles for the establishment and application of microbiological criteria for foods (1995)» Control of L. monocytogenes in foods (1995)

36 Micro-organisms in Foods book series / /

37 Paper & software tool on performance of sampling plans oftware_downloads.html **The mean concentration detected is 1 cfu in 526g (if the assumed standard deviation is 0.8 and probability of detection is 95%). (Input into Codex standards for Cronobacter and Salmonella in PIF, CAC, 2008)

38 Paper & software tool to assess meeting FSO

39 Outline» International Resources (Codex, FAO, WHO, ICD, ICMSF)» Regional Resources (European Commission, EFSA, ILSI-Europe)» Resources at FoodRisk.org (USA-based)» Other Resources

40 Regional level Europe FOOD SAFETY MANAGEMENT EUROPEAN COMMISSION (DG SANCO) SCIENTIFIC ADVICE EFSA

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44 publications.htm Salmonella and Norovirus in leafy greens eaten raw as salads Scientific Opinion - Published: 27 March 2014 Annual Report of EFSA s MRA Network Technical report - Published: 13 December 2013 Salmonella spp. in broiler (Gallus gallus) meat production External Scientific Report - Published: 26 July 2011 A quantitative microbiological risk assessment of Campylobacter in the broiler meat chain External Scientific Report - Published: 7 April 2011 Salmonella in slaughter and breeder pigs Scientific Opinion of the BIOHAZ Panel - Published: 19 April 2010 QMRA on Salmonella in Slaughter and Breeder pigs External Scientific Report - Published: 19 April 2010 Risk assessment on parasites in fishery products Scientific Opinion of the BIOHAZ Panel- Published: 14 April 2010

45 An example of useful EFSA output for food safety risk managers

46 An example of useful EFSA output for food safety risk managers

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49 Resources from ILSI-Europe Risk Analysis in Food Microbiology task force

50 Resources from ILSI- Europe Risk Analysis in Food Microbiology task force

51 Resources from ILSI-Europe Food Intake Methodology task force

52 GUIDEA ( Guidance for Dietary Intake Exposure Assessment Intended to assist the user in obtaining answers to the following questions: What type of assessment is appropriate for which purpose? How should assessments be conducted? How should assessments be reported? GUIDEA is NOT an exposure assessment tool or software (e.g. FACET). GUIDEA is NOT a database for occurrence or consumption data (but provides links to occurrence and consumption databases and examples on how this data can be used in dietary exposure assessments). GUIDEA does not provide information or advice about legal issues arising from scientific regulatory affairs.

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54 FACET Flavourings, Additives, and Food Contact Materials Exposure Tool EU FP7 Project, collaborative partners across the EU Overall Aim Databases Harmonised database on nationally available food intake data Database on occurrence of target food chemicals in foods Models/Tools Exposure Software for estimating exposure to target food chemicals Migration model for multi-layer packaging

55 The FACET Exposure Tool Amount of Food Concentration of Substance Dietary Exposure Databases of chemical concentrations for flavourings and additives, chemical occurrence data, industry data on retail packaging composition, and food consumption diaries. These databases are combined in probabilistic dietary exposure models that estimate exposure in different populations of consumers in the EU. Freely Available for Download -cons-prod/chemicals_in_food/facet

56 Outline» International Resources (Codex, FAO, WHO, ICD, ICMSF)» Regional Resources (European Commission, EFSA, ILSI- Europe)» Resources at FoodRisk.org (USA-based)» Other Resources

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58 FoodRisk.org is operated by Joint Institute for Food Safety and Applied Nutrition (JIFSAN) in collaboration with the Center for Food Safety and Applied Nutrition from US Food and Drug Administration (CFSAN/FDA) and the Food Safety and Inspection Services from US Department of Agriculture (FSIS/USDA). The aim of FoodRisk.org is to assist professionals involved with the many aspects of risk analysis as it pertains to the safety of our food. On FoodRisk.org you will find unique datasets, tutorials, tools, and links to numerous sources of information.

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61 Microbial Risk Assessment Repository The repository contains completed food safety microbiological risk assessments. The documents deal with zoonotic pathogens, as well as mycotoxins, viruses, and parasites, in both food and water. Antibiotic resistance risk assessments are also included.

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67 FDA-iRISK What can it do? Quickly compare risks from many types of hazards and foods Various points in supply chain Different populations Effectiveness of interventions Enable relatively rapid quantitative risk assessments Built-in mathematical architecture Modular & expandable Express results using a variety of metrics Mean risk of illness, total cases Common health metric (Disability Adjusted Life Years) Public version released October 4, 2012, via JIFSAN (FDA, 2013)

68 Integrates Data and Information on Seven Elements Food Hazard Population Address the question: What risk does a hazard - food pair pose to a population? (FDA, 2013)

69 FDA irisk A risk ranking tool to compare public-health impact of microbial and chemical hazards (and more ) One Hazard in Different Foods Salmonella Multiple Hazards in a Single Food Leafy Greens Fresh Produce Shell Eggs Norovirus Cyclospora Nuts Enterohemorrhagic E. coli Multiple Hazards in Multiple Foods L. monocytogenes in Soft Cheese Scombrotoxin in Raw Tuna Salmonella in Peanut Butter (FDA, 2013)

70 FDA-iRISK Information Portal

71 Outline» International Resources (Codex, FAO, WHO, ICD, ICMSF)» Regional Resources (European Commission, EFSA, ILSI- Europe)» Resources at FoodRisk.org (USA-based)» Other Resources

72 Quantitative Microbial Risk Assessment (QMRA) Wiki

73 QMRA Wiki

74 Predictive Microbiology and Risk Assessment» Since the late 1980 s» Models predicting growth and survival of microorganisms in food» User friendly software/tools developed by different research groups internationally» Predictive microbiology tools are useful to support Exposure Assessment in the context of risk assessment

75 Predictive Microbiology and Risk Assessment distribution and retail, home storage preparation primary production processing distribution and retail, home storage preparation primary production processing distribution and Predictive manufacturing microbiology retail, home storage preparation D R public health burden primary production processing distribution and retail, home storage preparation distribution and retail, home storage preparation

76 Predictive Microbiology Tools USDA Pathogen Modeling Program ComBase DMFit Microbial Response Viewer GInaFiT Sym Previus Food Spoilage Predictor (FSP) Seafood Spoilage and Safety Predictor MicroHibro PMM-Lab. and others

77 ComBase

78 Summary» Around the world, governments are adopting Risk Analysis as the framework for risk-based decision making.» Risk assessment approaches and methods for chemical hazards are long established. In recent years, approaches for risk assessment of microbiological hazards have rapidly developed resulting in a wide range of resources available.» Many resources are available to food safety professionals that need to acquire skills in risk assessment.» True skills will only develop through experience and use in practice.» In support of this, an international community of practice of risk assessors would be very beneficial.

79 Acknowledgements» Dr. Leon Gorris (Unilever)» Dr. Yuhuan Chen (U.S. Food and Drug Administration)

80 THANK YOU