Application of Risk Analysis / HACCP:

1. Application of Risk Analysis / HACCP: Case of Milk-Borne Public Health Risks Analysis in Milk Markets in Kenya Presentation at Workshop on Impacts of Urban and Peri-urban Livestock Systems on Public and Ecosystem Health in Nigeria 18-19 Sept 2002 ILRI-IBADAN, NIGERIA A. Omore ILRI-Kenya

2. Major issues in regulation for food safety in dairy markets in Kenya Limited information base for policy formulation, therefore reliance on Western models However, raw milk markets dominate mainly because most consumers refuse to pay higher costs that pasteurisation and packaging incurs Need for risk information to balance trade-offs between food safety and economics Risk analysis is the right approach

3. Percent milk marketed informally in selected countries in Africa & elsewhere Sub-Saharan Africa Percent Kenya 88 Tanzania 98 Uganda 90 Central America Nicaragua 86 Costa Rica 44 South Asia India 83 Sri Lanka 40 Typical Small milk trader in Kenya

4. Assessment of risks S A M B U R U T A R M A K W E T R A N S - N Z O I A I S I O L O M T . E L G O N B A R I N G O B U N G O M A U A S I N G I S H U I B U S A L G E E Y O N Y A M B E N E G K A K A M E A L A I K I P I A M E R U N A N D I K O I B A T E K V I H I G A S I A Y A M E R U S O U T H K I S U M U N Y A N D A R U A T H A R A K A N A K U R U K E R I C H O N Y E R I E M B U K I R I N Y A G A N Y A M I R A K I S I I H O M A _ B A Y M B E E R E M U R A N G A B O M E T G U C H A M A R A G U A M I G O R I T H I K A K I A M B U K U R I A N A I R O B I N A R O K M A C H A K O S N o . p e r S q K m 0 - 2 . 1 T A N A R I V E R K I T U I 2 . 1 - 1 0 .8 1 0 . 8 - 3 3 . 9 M A K U E N I 3 3 . 9 - 5 6 . 2 K A J I A D O 5 6 . 2 - 1 3 1 . 1 Study sites and Dairy Density • Nakuru/ • Narok: • Extensive production • Medium market access • Exotic & • Zebu cattle • Nairobi/ • Kiambu: • Intensive production • High market access • Exotic cattle Sites differentiated between levels of market access and production system

5. Study methods Participatory research and structured data collected between 1999 and 2001 Data included milk pathways, handling practices by market agents and consumers, laboratory hazard assessments, economic & GIS

6. Analytical approaches Health Risk Analysis for each hazard using HACCP as a tool/guideline What is Risk analysis? What is HACCP?

7. Analytical approaches (cont’d) Definitions: Risk and Hazard Risk = Fn of both probability (likelihood) & magnitude (impact) of an adverse effect from a hazard Hazard = A biological, chemical or physical agent in food that may have adverse health effect

8. Analytical approaches (cont’d) Definitions: Risk Analysis Components Risk Analysis is a process consisting of three components: 1. Risk Assessment 2. Risk Management 3. Risk Communication

9. Analytical approaches (cont’d) Definitions: Risk Assessment • 1. Risk Assessment = The scientific evaluation of adverse health effects from exposure to a food-borne hazard. It involves these steps: • Hazard identification • Hazard characterisation: qualitative / quantitative / dose-response • Exposure assessment: evaluation of degree of intake • Risk characterisation: integration of above and reference to a population and uncertainties

10. Analytical approaches (cont’d) Definitions: Risk Mgt & Communication 2. Risk Management: The process of weighing policy alternatives to accept, minimise or reduce assessed risks and to select and implement appropriate options 3. Risk Communication: An interactive process of productive exchange of information with stakeholders

11. Analytical approaches (cont’d) Definitions: HACCP Hazard Analysis Critical Control Points (HACCP) is a tool/guideline for risk analysis. Originally applied to food for astronauts HACCP is designed to prevent problems before they occur and to correct deviations as soon as they are detected. Such preventive control systems with documentation and verification are widely recognized as the most effective approach for ensuring food safety. HACCP reduces regulatory enforcement costs

12. Analytical approaches (cont’d) Definitions: HACCP Steps/principles • Assessment of risks in the food chain (use conceptual flow-diagrams) • Determination of critical control points (CCPs): Points for remedial action • Determination of Critical Limits (CL) • Development of monitoring systems • Implementation of monitoring procedures • - Corrective action, Documentation & Verification Challenge: Adapting HACCP concept to informal food market situations

13. Analytical approaches (cont’d) Laboratory Hazard Assessment in Kenya • Total & Coliforms Bacteria. • Butter-fat • Added water • Brucella abortus • E. coli 0157:H7 • Antibiotics & antibacterials • Bovine TB (M. bovis) in humans : SPC : Gerber Method : Specific gravity : MRT, ELISA : Culture & typing : Charm tests : Culture and PCR Hazards to be investigated were identified at the initial stakeholder consultation

14. Analytical approaches (cont’d) Risk factors (Risk characterisation) in Kenya Consumer preference, market structure, conduct and performance Market margins Spatial factors affecting marketing behaviour and performance Regression, principal component and clustering of milk quality indicators & profit parameters

15. Highlights of Results of Risk Characterisation Percent of Households Buying Raw and Pasteurised Milk in Kenya 100 Raw 80 Pasteurised % hh 80 93 78 60 40 34 29 20 5 0 Nairobi Nakuru urban Nakuru rural

16. Raw milk preferred due to its low price Milk prices (1999) Mean Price (KSh/Litre Area Raw milk Pasteurised milk Nairobi 31.5 40.0 Nakuru urban 25.3 41.0 Nakuru rural 18.4 41.0 Lower prices for raw milk in rural areas and as distance · from Nairobi increases

17. Quantity of pasteurised and raw milk purchased in Nairobi, by income groups 40 Raw Pasteurised 30 Lts 20 10 0 <2500 2500- 5000- 10000- 20000- >30000 4999 9999 19999 29999 Income Groups (KSh) • Higher quantities consumed as income increases • Price is not the only determinant of raw milk consumption. Tastes and preferences also count

18. Overview of lab. results Adulteration • KEBS standards for specific gravity <1.026kg/l (added water) & >1.032kg/l (added solids) applied • Added Water % Added solids % • Consumer hh 5 6 • Mkt agents 10 1 • Adulteration highly variable by season & area • All traders had some adulterated milk • Tendency to add water during periods of low milk supply and high milk prices

19. Bacterial counts (cfu/ml):% bad/very bad(KEBS) Raw: TC>2M, CC>50,000; Pasteurised: TC>30,000, CC>10 Total Bacteria Coliform Bacteria 100 80 % 60 Samples 40 20 0 Farmer grp Milk Bar Shop/Kiosk Mobile Pasteurised- Supermkts Pasteurised- Kiosks Trader type • High counts in urban; low counts in rural areas • Lack of effective preservation e.g., cooling. Standards? • Significant deterioration before first transaction

20. Zoonoses Brucella abortus antibodies % 30 20 Season 1 % hh/ Season 2 agents 10 0 MRT ELISA MRT ELISA Urban hh Rural hh Informal agents Pasteurized milk • Bulking of raw milk  higher risk of brucellosis • 6% of rural hh consume home-made fermented milk • E. coli 0157:H7 2 out of 264 (<1%) • No M. bovis

21. % Health awareness of milk-borne hazards 100 100 100 96 80 65 60 % 40 44 20 23 0 Nairobi urb Nakuru urb Nakuru rural Aware Boiling • Nearly all hh boiled marketed milk prior to consumption but some naturally fermented milk also consumed

22. Antibiotics & antibacterials (Charm AIM-96 Test) % above acceptable limits (EU/Codex Alimentarius MRLs) 20 15 % hh / 10 agents 5 0 Milk bars Past. Coops Shops / Small Urban hh Rural hh Kiosks traders • All common antibiotics & antibacterials tested (penicillins, tetracyclines, sulphonamides, aminoglycosides & macrolides) • The major health risk found. • An average Kenyan consumer is exposed to milk with unacceptable residue levels twice every month!

23. Antibiotics & antibacterials (Charm AIM-96 Test) Detection levels of Charm-AIMtest, MRLs and ADI Drug Min. test EU/Codex Codex ADI Range g/kgMRLs g/kg Penicillin G 3-4 4 30 g/day Oxytetracycline 150-300 100 30g/kg bwt

24. Factors associated with milk quality (OLS) Total bacteriaColiformsSNF Nairobi/Kiambu Strong (+++) Strong (+++) Wet season Strong (+++) Medium(--) Medium (--) SNF Medium(+++) N/A Market Pathways (relative to Farm-coop) Farm-Shops/kiosk Weak (+) Medium (--) Coop-Shop/kiosk Weak (+) Mobile trader-Milk bar Medium (--) Milk handling Milk preservation Weak (-) Plastic container Medium (++) Scooping vs pouring Medium (++) Piped water Medium (++) Other covariates Time since collection Strong (+++) Profit Margin/lt Strong (---)

25. Major risk factors (CCPs) in milk handling and critical points • Antibiotics & antibacterials Major risk that heat treatment cannot address Long term issue to be addressed mainly at farm level • Bacterial risks: Can be addressed by boiling/pasteurization • Total Bacteria Wet season, Time before and after first transaction, Pathways from farms to shops/kiosks and milk bars • Coliform Bacteria • Lack of training, Scooping vs. pouring, Plastic containers • Zoonoses • Fermented milk is a potential source; No Bovine TB

26. Current licensing requirements do not promote good milk quality in Kenya Summary of means of new variables & major clusters (principal component and cluster analysis) Cluster Large scale Low High Long SCALE Freq. /Experience quality margin Time 22-0.310.29-1.470.48Small: 44 l/d 158-0.25 -0.06 -0.19 0.06 Small: 126 l/d 120-0.37 -0.01 0.58 0.08 Small: 108 l/d 252.74-0.29 0.11 0.07 Large: 5,536 l/d 22 0.89 -0.36 -0.21 -0.03 Medium: 367 l/d • Small traders grouped together irrespective of licensing • Quality is not a problem for majority of small traders (relatively) • Training/experience helps to significantly improve milk quality • Can target specific groups and market pathways

27. Conclusions (risk assessment) Consumers generally prefer whole raw milk but this fact is currently ignored by policy makers More than 50% of samples exceed current hygiene standards Nearly all consumers who purchase milk boil it before consumption Antimicrobials are the major public health risk Some risk from consumption of naturally fermented milk Small traders use cheap and poor quality containers mainly due to policies that exclude them

28. Conclusions (risk management) Policy is ineffective since the quality of traded but unlicensed milk does not differ significantly from licensed milk Tradeoffs should consider actual risks, consumer preference and ‘safety’ as perceived by them Appropriate public intervention should be through consumer education Alternative approach of training and certification of market agents should result in better milk quality and better service to consumer preferences Role for self-regulation?

29. Conclusions (risk communication) Communicating the risk information has largely been productive with some positive changes in mindsets Policy was/is important and policy-makers were therefore directly included in research and testing of interventions. Private sector and NGOs also included Stakeholders gathered in early 2001 mandated policy makers to form a committee to refine recommendations and oversee their implementation

30. Conclusions (risk communication cont’d) Engage in public debate Contribution to changing policy environment: Drafts of Policy & Bill explicitly recognize the predominance of small scale raw milk markets and are supportive However, additional changes in legislation and institutions will be required to realize the desired changes in the new DDP

31. Acknowledgements Co-investigators and Institutional Collaborators University of Nairobi: S. Arimi, E. Kangethe Graduate Students: A. Mwangi, G. Aboge, R. Koech, E. Koroti KEMRI: J. Odhiambo, E. Juma Egerton University: Dept. of Dairy Techn. & Food Sci ILRI MOSD staff + J. McDermott MoARD H. Muriuki DFID bilateral Support to SDP