REGIONAL TRAINING ON FOOD SAFETY/AFLATOXIN CONTROL FOR REGIONALLY HARMONIZED SAMPLING AND LABORATORY

PROCEDURESFEBRUARY, 28TH and 29TH 2012AT KEPHIS HQ, Nairobi, Kenya

TECHNICAL REPORT

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Table of ContentList of Abbreviations and acronyms.........................................................3Executive summary......................................................................................51. Introduction....................................................................................62. The Sessions...................................................................................7

2.1 Opening session................................................................................72.2 Food quality control in the entire food value chain session...............8

2.2.1Food control systems.........................................................................82.2.2Mycotoxin management in food value chain: the case of aflatoxin in

Kenyan maize..................................................................................102.2.3Discussion........................................................................................13

2.3 Sampling and analysis.....................................................................132.3.1Food Chemical Contaminants – Aflatoxins.......................................132.3.2Food Overview of sampling and analytical methods for aflatoxins. 152.3.3Discussion........................................................................................19

2.4 Mycotoxin regulatory limits.............................................................192.4.1Overview of mycotoxin regulation worldwide..................................192.4.2Application of biocontrol in managing aflatoxin in Africa: the case of

Aflasafe............................................................................................282.4.3Registration and Certification Guidelines for Biocontrol Agents

(Biopesticides, Biofertilizers, Bioexclusion Agents).........................302.4.4Discussion........................................................................................33

2.5 Closing session................................................................................332.6 Pictorials..........................................................................................34

3. Way forward..................................................................................364. Annexes.........................................................................................37

Annex 1 Program........................................................................................37Annex 2 Official opening statement............................................................39Annex 3 Welcoming Remarks.....................................................................42Annex 4 Example of a food safety notification linked to aflatoxin by the UK....................................................................................................................44Annex 5 Participants list.............................................................................45

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List of Abbreviations and acronyms

Items Actual wordA.O.A.C Association of Official Analytical ChemistsAATF African Agricultural Technology FoundationAPHIS Animal and Plant Health Inspection ServiceBCAs Biocontrol agentsCAADP PP Comprehensive Africa Agriculture Development Programme

Partnership ProgrammeCBS Chief of the Order of the Burning SpearCDC Centres for Disease Control and PreventionCEN European Standardization CommitteeCOMESA Common Market for Eastern and Southern AfricaDON De-Oxy-NivalenolDRC Democratic Republic of CongoDVS Department of Veterinary ServicesEAC East Africa CommunityEC European CommissionELISA Enzyme Linked Immuno Sorbent AssayEU European UnionFAO Food and Agriculture OrganisationFDA Food and Drug Administration of USAGAP Good Hygiene PracticesGHP Good Husbandry PracticesGMOs Genetically Modified OrganismsGMP Good Manufacturing PracticesHACCP Hazard Analysis and Critical Control PointHIV Human immunodeficiency virusHPLC High Performance Liquid ChromatographyIAC Immuno Affinity ChromatographyICIPE International Centre of Insect Physiology and EcologyIITA International Institute of Tropical AgricultureIPPC International Plant Protection ConventionISO International Organization for StandardizationISPM International Standards For Phytosanitary MeasuresKARI Kenya Agriculture Research InstituteKEBS Kenya Bureau of StandardsKEPHIS Kenya Plant Health Inspectorate ServiceKSTCIE Kenya Standing Technical Committee for Import and ExportsMAE Microwave Assisted ExtractionMC Moisture Contentmg/kg Milligrams / Kilograms

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MoA Ministry of Agriculture in KenyaMPHS Ministry of Public Health and Sanitation in KenyaMRAs Mutual Recognition AgreementsMRLs Maximum Residue LevelsNEMA National Environment Management Authority in KenyaNGOs Non-Governmental OrganisationsNIV NivalenolNMK National Museum of KenyaOTA Ochratoxin APACA Partnership for Aflatoxin ControlPAHs Polycyclic aromatic hydrocarbonsPCPB Pest Control Products BoardPMTDI Provisional Maximum Tolerable Daily Intakeppb parts-per-billionPR Public Relations PTWI Provisional Tolerable Weekly IntakeRA Risk AssessmentRAS Romer Analytical SamplingSFE Supercritical fluid extractionSPE Solid Phase ExtractionSPS Sanitary and PhytosanitaryTBT Technical Barriers to TradeTLC Thin Layer ChromatographyUSA United States of AmericaUSAID United States Agency for International DevelopmentUSDA United States Department of AgricultureUSDA-ARS United States Department of Agriculture - Agricultural

Research ServiceUSDA-FAS United States Department of Agriculture - Foreign Agricultural

ServiceWTO World Trade OrganisationWTO SPS World Trade Organisation Sanitary and PhytosanitaryZEA Zearalenone

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Executive summary

Today, intra regional trade in the COMESA region is well over US$17 billion and is still growing. There is evidence that volumes of trade within the region are growing versus the rest of the world. Globally, it is estimated that 25% of world food crops especially maize, peanuts, cassava is affected by aflatoxin contamination. The importance of mycotoxins in Africa are illustrated by the high levels of certain types of cancer like the hepatocellular carcinoma, which is a common type of liver cancer; available research and evidence points to recurring outbreaks of aflatoxin contamination in some COMESA countries that have caused death, serious illnesses and interrupted trade like to South Africa and EU.

In order to address these issues COMESA in partnership with KEPHIS organised a two day training workshop on 28th and 29th February 2012 at the KEPHIS headquarters in Karen, Nairobi, Kenya where a regional action plan was developed to ensure a regionally harmonised Food Safety Systems for Aflatoxin Control and harmonized regulatory framework for aflatoxin biocontrols. 19 participants from the COMESA countries of Burundi, Congo DRC, Comoros, Egypt, Kenya, Madagascar, Malawi, Mauritius, Seychelles, Sudan, Swaziland, Uganda, Zambia and Zimbabwe were present; they were mainly laboratory analysts and SPS regulators.

The function was officially opened by the Guest of Honour, Permanent Secretary in the Ministry of Trade in Kenya, Engineer Abdulrazaq Adan Ali who said that aflatoxin is a multi-faceted trans-boundary problem that requires a holistic approach involving public and private stakeholder participation, a sector-wide approach, regional and international collaboration and new approaches such as the use of bio control technologies that have been successful in other parts of the world like USA need to be introduced to tackle the challenge. Emphasising that across the region, countries continue to intercept contaminated grain, which is destroyed at the cost of the trader, he emphasised the need foreffective food safety regulatory systems and credible laboratories for wider recognition of certificates of analysis. He noted that efforts from this training will consolidate the gains we have made on regional integration by facilitating trade in aflatoxin sensitive foods. In conclusion, this training was important as participating COMESA countries developed a regional action plan with specific objectives and outcomes, which will be supported by COMESA and key partners

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1. IntroductionThe importance of mycotoxins in Africa are illustrated by the high levels of certain types of cancer like the hepatocellular carcinoma, which is a common type of liver cancer; the strong links between HIV infection rates and mycotoxin intake, negative correlation between aflatoxin in the diet and stunted growth in children as well as frequent rejections of regional groundnut exports to the EU and South Africa; available research and evidence points to recurring outbreaks of aflatoxin contamination in some COMESA countries that have caused death, serious illnesses and interrupted trade. As a result, Governments and donors have stepped up efforts to address the aflatoxin problem in a coherent and integrated manner. The 7th

CAADP PP held in Yaounde March 2011, endorsed the decision to establish an African led partnership for aflatoxin control (PACA) within the CAADP framework to mobilise resources and ensure effective coordination of the various actors engaged in addressing the aflatoxin problem at national, regional and continental levels. COMESA has actively engaged in the initial stages of conceiving PACA and subsequent endorsement at the 7th CAADP PP. In an effort to coordinate regional effort, the COMESA SPS programme articulated interventions that require collective action by member states. These include a number of regionally harmonized key areas – food control measures focusing on entire value chains, sampling and laboratory testing procedures, harmonised aflatoxin limits and registration guidelines for bio controls.

In order to address these issues COMESA in partnership with KEPHIS organised a two day training workshop on 28th and 29th February 2012 at the KEPHIS headquarters in Karen, Nairobi, Kenya with the major objective being to developing a regional action plan that will lead to regional protocols for sampling and testing of aflatoxins. The target countries were COMESA countries of Burundi, Congo DRC, Comoros, Egypt, Kenya, Madagascar, Malawi, Mauritius, Seychelles, Sudan, Swaziland, Uganda, Zambia and Zimbabwe. The participants were mainly laboratory analysts and SPS regulators.

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2. The Sessions 2.1 Opening session

Dr. Joseph Ahenda, General Manager-Quality Assurance in KEPHIS called the meeting to order. The training started with word of prayer from Luiza Munyua of KEPHIS. He recognised the presence of Permanent Secretary-Trade, Engineer Abdulrazaq Adan Ali; Managing Director-KEPHIS, Dr. James Onsando; COMESA secretariat representatives led by Ms. Martha Byanyima; Dr. Esther Kimani, General Manager-Phytosanitary Inspection; and the training facilitators from COMESA, University of Nairobi, KEPHIS and IITA. This was followed by self Introduction of all participants.

Ms. Martha Byanyima, COMESA secretariat representative, thanked the participants for coming and mentioned that big losses are incurred in trade when aflatoxins are found in commodities; she mentioned the reason for the training workshop was to begin work on establishing agreed sampling and testing protocols for aflatoxins; with the expected output a regional action plan that will lead to regional protocols for sampling and testing of aflatoxins. She noted that member countries had different ways of dealing with aflatoxin but this training workshop was supposed to start work towards harmonising sampling and testing of aflatoxins.

Managing Director-KEPHIS, Dr. James Onsando in giving welcoming remarks mentioned that aflatoxins has become an important issue as it has caused death, serious illnesses and interrupted trade; and it is also associated with high levels of certain types of cancer, e.g. hepatocellular carcinoma, which is a common type of liver cancer. Hence this training is important as many countries in the COMESA region are participating and efforts derived from this should promote an integrated approach to the issue; systems show follow a farm to fork (HACCP) approach which will limit the risks of aflatoxin contamination at each step along the food chain; also concerted efforts of all actors along the food production chain should be encouraged. Simple efforts like ensuring proper drying of maize should be encouraged.

The Guest of Honour, Permanent Secretary in the Ministry of Trade in Kenya, Engineer Abdulrazaq Adan Ali officially opened the training and said that globally, it is estimated that 25% of world food crops especially maize, peanuts, cassava is affected by aflatoxin contamination. Aflatoxin is a multi-faceted trans-boundary problem that requires a holistic approach involving public and private stakeholder participation, a sector-wide approach, regional and international collaboration and new approaches such as the use of bio control technologies that have been successful in other parts of the world like USA.

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He mentioned that Kenya is privileged to host this training for a number of reasons; the first being in the last decade, the country has had several outbreaks of aflatoxin poisoning that caused serious illnesses and several deaths. This meant the Kenya Government embraced integrated management strategies combining food safety controls and public awareness campaigns with biological technology to suppress the fungal infection. This has been highly participatory, spearheaded by the Kenya Agriculture Research Institute (KARI). The experience is that integrated management strategies are effective in controlling aflatoxin contamination. The second reason is that the COMESA region has made good progress on economic integration and intra regional trade. The launch of the Free Trade Area in the year 2000 and the Customs Union three years back (on 7 th

June 2009) is evidence of the effort we have all painstakingly put together towards an economically integrated region. Today, intra regional trade is well over US$17 billion and is still growing. There is evidence that volumes of trade within the region are growing versus the rest of the world. This is not happening by accident; it is because of an improved business and investment environment that we have all contributed to as COMESA member states.

He noted through examples that the absence of harmonized regulatory systems for aflatoxin control is undermining the gains made on economic integration. The training will provide an opportunity for national experts to discuss and agree on the most acceptable sampling and testing procedures to be adopted by regional laboratories. This will facilitate cross border traders in a significant way as certificates of analysis will no longer be rejected when laboratory procedures are the same in every country. Kenya has made good progress on bio-control measures for aflatoxins and is ready to share lessons with other countries, particularly, Malawi and Zambia which have embarked on trials. Also, it is important to emphasize the need for regionally harmonized bio control registration guidelines. This will encourage investments, commercialization and scaling up use of the technology regionally. The existing regulatory environment in majority of COMESA countries, is tailored for agrochemicals, and does not suit natural remedies such as bio-controls. Finally, this meeting offered an opportunity for agreeing on regional actions for a harmonized approach that will facilitate intra regional trade in aflatoxin sensitive foods.

2.2 Food quality control in the entire food value chain session

2.2.1Food control systems

Rosemary Nganga from KEPHIS took participants through a discussion on food control systems with emphasis on food safety notifications and market requirements.

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In her presentation she was able to define a food control system as a mandatory regulatory activity of enforcement by national or local authorities to provide consumer protection and ensure that all foods during production, handling, storage, processing, and distribution are safe, wholesome and fit for human consumption; conform to safety and quality requirements; and are honestly and accurately labelled as prescribed by law.

She mentioned that food safety is linked or associated with ensuring that all those hazards, whether chronic or acute, that may make food injurious to the health of the consumer are prevented.

The focus of a food control system are prevention of microbiological hazards, agrochemical pesticide residues, misuse of food additives; mycotoxins and other biological toxins, adulteration, GMOs, residues of veterinary drugs and growth promoting hormones.

Challenges in a food control system include: increasing burden of food-borne illness and new and emerging food-borne hazards; rapidly changing technologies in food production, processing and marketing; Developing science-based food control systems with a focus on consumer protection; International food trade and need for harmonization of food safety and quality standards; Changes in lifestyles, including rapid urbanization; Growing consumer awareness of food safety and quality issues and increasing demand for better information; Sector segmentation of food safety control responsibilities.

Global consideration - International trade; Codex Alimentarius commission; WTO Agreements i.e. Sanitary and Phytosanitary (SPS) on right for countries to apply measures for protection of human, animal and plant life and health; Technical Barriers to Trade (TBT) on technical regulations e.g. on packaging, will not be more restrictive on imported products than on those produced domestically. These are complimented domestically by Food laws and regulations; Food control management; Inspection services; Laboratory services and; Information, education, communication and training. All these must apply principles like Integrated farm to table concept (GAP, GMP, GHP and HACCP-ISO: 22000); Risk Analysis; Transparency; and Regulatory Impact assessment

On organizational structure, three were identified i.e. multiple, single and integrated; these are explained below. Multiple Agency – Fragmented; Effected through: General Food Law and sectoral Regulations; Drawbacks include: Lack of overall coordination at national level, Frequent confusion over jurisdiction and resultant inefficiencies in performance, Reductions in the confidence of domestic consumers and foreign buyers in the credibility of the system. Single Agency – Consolidation of all responsibility for protecting public health and food safety into a single food control agency

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with clearly defined terms of reference; The merits of a single agency include uniform application of protection measures, Ability to act quickly to protect consumers, Improved cost efficiency and more effective use of resources and expertise, Harmonization of food standards. Integrated system – Capacity to quickly respond to emerging challenges and the demands of the domestic and international marketplace; the provision of more streamlined and efficient services, benefiting industry and promoting trade. The system is best for achieving effective collaboration and coordination between agencies across the farm to table continuum. Levels of operation include: Level 1: Formulation of policy, risk assessment and management, and development of standards and regulations. Level 2: Coordination of food control activity, monitoring, and auditing. Level 3: Inspection, and enforcement. Level 4: Education and training. In the Integrated system an autonomous food safety agency is responsible for levels 1&2 while the multi-sectoral agencies are responsible for 3&4. The Advantages are is politically more acceptable as it does not disturb the day to day inspection and enforcement role of other agencies; separates risk assessment and risk management functions, resulting in objective consumer protection measures with resultant confidence among domestic consumers and credibility with foreign buyers; better equipped to deal with international dimensions of food control such as participation in work of Codex, follow-up on SPS/TBT Agreements, etcIn trade, there are a number of ways to notify: SPS notifications - Where a country notifies trading partners of changes in their SPS measures especially when they differ from international standards. TBT notifications - whenever a relevant international standard or guide or recommendation does not exist, or the technical content of a proposed or adopted technical regulation or procedure is not in accordance with the technical content of relevant international standards or guides of recommendations; If the technical regulation or conformity assessment procedure may have a significant effect on the trade of other Members. Interceptions through the EU Rapid Alert system for Food and Feed or even through the media. Examples of food safety related interceptions: Chemical Residues in French beans; Spoilage of vegetables; Shigella in snow peas; Heavy metals in pineapples. Market requirements are found in the local market or the Export market (Adoption of Just-in-Time Export Strategy, Knowledge of customer requirements in the target market, Availability, Quality, Safety, Documentation of TBT and SPS requirements, reports and inspection certificates, Mutual Recognition Agreements-MRAs).

In conclusion the presenter mentioned that: There is need to adopt the integrated farm to table concept; have a food control system for promotion of food safety for both the local and international markets; Work with competent authorities to ensure food quality and safety; Locally have an alert system for food safety.

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2.2.2Mycotoxin management in food value chain: the case of aflatoxin in Kenyan maizeDr. James Muthomi of University of Nairobi took participants through the presentation above; this is detailed below.

Mycotoxins are toxic secondary metabolites produced by fungi in agricultural products. They are produced during production, harvest, transportation, storage & food processing; contaminated maize may appear normal; processing & cooking does not destroy aflatoxins; Detection is complicated due to limitations in analytical capacity; Aflatoxin poisoning continues to cause disease & death of many people in rural areas of Eastern Kenya

Major food borne mycotoxins are detailed as: Aflatoxins (B1, B2, G1 & G2)produced by Aspergillus flavus, Aspergillus parasiticus found mainly on Maize, pistachio nuts, chestnuts, almonds, cashewnut, walnuts, macadamia nut, hazelnut, dry fruits (figs), spices, groundnuts; Aflatoxin M1 produced by Metabolite of aflatoxin B1 found in Milk & milk products; others include Ochratoxins, Deoxynivalenol (DON), Nivalenol (NIV), Zearalenone (ZEA), Fumonisins, T-2 and HT-2 toxinsFactors leading to mycotoxin contamination in grain are agronomic - stress during crop growth e.g. drought, cultivation of susceptible crop varieties and practices of harvesting, drying and storage; post-harvest handling - grain storage moisture content, Storage temperature, Insect damage – weevil infestation, Proportion of broken kernels (physical damage), Proportion of oxygen and Co2 in intergranular atmosphere

Maize can safely store for 1 year at 15% MC and at 15oC; same grain stored at 30oC will be damaged by moulds within 3 months

Effect of fungal and mycotoxin contamination

Contamination by fungi reduces quality (discolouration, reduction of nutritional value) & mycotoxin production

Mycotoxin poisoning - through ingestion, inhalation & skin absorption Mycotoxins impact on human health, animal productivity & trade High-level exposure instant death; long-term chronic effects include

cancer, mutagenicity and nervous disorders ; death of humans & animals

Hospitalization of hundreds of people suffering from jaundice Monetary losses - destruction of huge consignments of contaminated

grain e.g. 3 million bags of maize was destroyed in 2010 due to contamination

Loss of agricultural productivity due to weakened farming communities

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Effect on trade - Export of agricultural commodities, particularly groundnuts and groundnut products, have been affected by the stringent regulatory limits

Legislative limits also increase the cost of analysis Costs - inspection, sampling and analysis, losses attributable to

compensation paid in case of claims, farmer subsidies to cover production losses, research, training and extension programme costs, costs of detoxification

Pictorials

The table below expounds on cases of aflatoxin poisoning reported in Kenya from 1981 to 2010:

Year Number of cases

Number of deaths Areas of occurrence

1981 20 12 Machakos district 2001 - 12 Meru 2003 - 68 Eastern province 2004 317 125 Thika, Kitui, Makueni 2005 75 32 Kitui and Makueni 2007 84 21 Meru, Kitui, Makueni 2008 6 2 Eastern province 2010 24 3 Kitui (Mutomo) and Makueni Source; Lewis et al., 2005; KEPHIS, 2008; Daily nation 2010.

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Percentage isolation frequency of Aspergillus spp in maize flour from eastern Kenya

Mycotoxin management in food value chain – HACCP: Integrated system based on the Hazard Analysis and Critical Control Point (HACCP) approach; HACCP approach involves prevention, control, good manufacturing practices, and quality control at all stages of production from the field to the final consumer; Control parameters include production practices, time of harvesting, temperature, moisture during storage and transportation, selection of agricultural products prior to processing, processing/decontamination conditions, temperature, addition of chemicals, and final product storage and transportation

Pre-harvest Control - Management of insect - insect damage provide infection routes for Aspergillus spp.; Crop residues management and crop rotation – rotation with non-cereals; Irrigation and soil condition management - drought stress enhances aflatoxin contamination in maize; high moisture & high relative humidity favour fungal growth & mycotoxin formation; Use of resistant varieties conventional breeding & genetic engineering; Harvest Control - timeliness, cleanup and drying

Post-harvest Control and Decontamination - Proper drying, storage and transportation (< 13.5% mc); Storage materials; Physical methods - Cleaning and segregation - electronic sorting and hand-picking; Milling – separates grain into different fractions; fractions with higher mycotoxin levels can be diverted to less risk uses or subjected to decontamination procedures

Mycotoxin management in food value chain - Physical methods of decontamination thermal inactivation (roasting for peanuts and coffee), Irradiation to reduce moulds, adsorbent clays in animal feed; Biological Decontamination - fermentation (aflatoxin is not degraded during the fermentation but the toxin is absent in the alcohol fraction after distillation); aflatoxin is concentrated in the spent grains; Ammoniation; Nixtamalization – use of traditional alkaline salts to partially degrade aflatoxin and fumonisin.

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2.2.3Discussion

After the presentations the participants discussed the questions below; which are later summarised into the action plan.

Points of discussion:

1. How is the food control system in your country organized? 2. What are the gaps and how can the food control system be

strengthened?3. Are there serious cases of mycotoxin contamination in your country;

what food products are most affected, magnitude and official reaction?4. What are the existing mycotoxin management strategies in our

countries?5. What are the legislative mycotoxin limits in your country?6. Are there serious cases of mycotoxin contamination in your country;

what food products are most affected, magnitude and official reaction?7. What are the existing mycotoxin management strategies in our

countries?8. What are the legislative mycotoxin limits in your country?

2.3 Sampling and analysis

2.3.1Food Chemical Contaminants – Aflatoxins

Rosemary Nganga of KEPHIS took participants through the presentation above; this is detailed below.

The definition of food - Any substance, whether processed, semi-processed or raw which is intended for human consumption, and includes drink, chewing gum and any substance which has been used in the manufacture, preparation or treatment of food but does not include cosmetics or tobacco or substances used only as drugs.

Effects of Unsafe Food - Negative impact on food security; Escalated national health bill; Loss of working hours due to illness; Negative impact on national and international trade; and reduced gains in tourism.

Chemical Dietary hazards include – mycotoxins, agrochemical pesticide residues, Heavy metals, Residues of veterinary drugs, other organics including PAHs, Furans, Dioxins; Non conforming food additives; and Radiation. When agrochemical pesticide residues are concentration above MRLs it will affect human health; health effects include cancer, damage to the nervous system among others; Kenya has suffered interceptions due to MRL exceedances. For heavy metals, those with adverse health effects include Cadmium, Mercury, Arsenic, Lead; they have health effects include

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kidney defects, bone fractures, Cancer, pulmonary and central nervous system damage, short-term memory loss, cerebral palsy among others; and Kenyan Pineapples were rejected by the EU in Sept 2006 due to presence of cadmium. Level found was 0.1 mg/kg Allowed Limit in the EU is 0.05 mg/kg.Residues of veterinary drugs - Damage of gut microflora; Allergenicity (Penicillin); Transfer of antibiotic resistant bacteria; Carcinogenicity (Sulphamethazine), Mutagenicity; Reproductive disorders; and Bone marrow toxicity (Chloramphenicol).

Health effects of mycotoxins - CDC estimates that 4.5 billion people exposed to mycotoxins in developing countries. Poisoning may occur through: Ingestion, Inhalation and Absorption through the skin. Health effects include: acute and leading to death; chronic; stunting and kwashiorkor; cancer; mutagenicity; Urogenital, vascular, kidney and nervous disorders; Some have the ability to compromise the immune response hence aggravating the effects of HIV aids

Mycotoxin Health Effects – Aflatoxins: Acute toxic hepatitis, Liver cancer; Ochratoxin A (OTA): Cancer, Neurotoxicity; Deoxynivalenol: Immunosuppressant; Zearalenone: Estrogenic effects- development of female characteristics in male pigs; Fumonisin: Esophageal cancer, Neural tube defects

Minimizing effects of mycotoxins include through the food chain approach; surveillance on imports and local produce; deactivation of infested produce; regulation - conduct Risk Assessment, Revise limits based on RA and updating on regulations by trading partners

RegulationBased on risk assessment this has risen steadily worldwide; In Kenya and WFP aflatoxins limit-10 ppb in maize, 4ppb in the EU; for FDA - Feed for cattle and swine for breeding- 100ppb, Finishing Swine- 200 ppb and Milk 0.5ppb; for EU - 10 ppb and 5 ppb for green and roasted coffee respectively but for Germany is 6 ppb and 3 ppb. Using 2004 data - FDA 2ppb fumonisins in grain would lead to US$ 20-40 million loss for Argentina, USA and China; while 0.5 ppb would lead to US$ 300 million loss

2.3.2Food Overview of sampling and analytical methods for aflatoxins

Dr. James Gathumbi took participants through the presentation above; this is detailed below.

INTRODCUTION - Since discovery of aflatoxins in early 1960s, many countries have established regulations to safeguard health of man and

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animals and for trade. There is general agreement that aflatoxins should be excluded from food and feed as much as possible. However, aflatoxins occur naturally and cannot be completely excluded. A certain level of toxin must be tolerated. Application of appropriate sampling and analytical procedures are important in regulation of aflatoxins levels in food.

WHY TEST FOR AFLATOXINS - Aflatoxins – cannot be seen, tastes, smelt or felt, hence some form of chemical testing is required. This will ensure informed decisions on whether to purchase a commodity can be done; also to determine suitability for various uses. This will safeguard public health and corporate image; testing also ensures a commodity meets regulatory requirements; testing will inform on remedial actions to be taken e.g. low inclusion and decontamination.

SAMPLING AND SAMPLE PREPARATION - The distribution of mycotoxins in foods is highly skewed and sampling error can be extremely high. For example, a single kernel contaminated with 400,000 ppb aflatoxin in a 4.54 kg corn sample causes that sample to have an overall concentration of 26 ppb aflatoxin. To detect and quantify mycotoxins in food, it is necessary to carefully obtain representative samples for laboratory analysis. Accurate aflatoxin test results require proper sampling procedures. Sampling requires serious attention, investment and manual work!

SAMPLING - In recognition of the difficulty of obtaining representative samples, various sampling plans have been published by various organizations. Detailed sampling and sample preparation plans have been described by United Nations Food and Agriculture Organisation (FAO, 1993) eg. Sampling Plans for Aflatoxin Analysis in Peanuts and Corn (FAO Food and Nutrition Paper 55) , Codex Alimentarius, Association of Official Analytical Chemists (A.O.A.C., 1995), European Union (E.U., 1998) e.g. Commission regulation (EC) No. 40/2006, US FDA e.g. USDA Grain Inspection Handbook, ISO, others. In Africa, sampling error can be unacceptably high. One bag of food may contain portions from several small-holder producers. Development of procedures for sampling of foods in Africa should be considered. If aflatoxin contamination is relatively high, a high variance will occur among samples, and many values will be higher than the average. Sampling variability can be reduced by increasing number and weight of incremental samples, increasing aggregate sample size, grinding aggregate samples finer and using a larger laboratory sample. Problem: higher costs, more time, more destructive. Sampling preferable when lots are in movement: during building or dismantling the stacks, loading or unloading trucks, wagons, ships etc. Sampling plans define the number and weight of incremental samples, aggregate sample and laboratory sample analytical sample per lot or sub-lot. It is advisable to contact the analytical laboratory prior to sampling. Ensure that samples are taken from the same lot i.e. they should have the same batch code or best-before-date. Take incremental

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samples of the appropriate weight at various places distributed throughout the lot. A representative aggregate sample should be composed of at least 100 incremental samples taken in a systematic random manner e.g. every 15th bag.Combine incremental samples together into one container to make up the aggregate sample to be submitted to the analyst. Send the entire aggregate sample to the analyst as soon as possible after collection. Cereals in bags – every bag for 1-10 bags, 10 bags random for 10 -100 bags, and from √n bags randomly for over 100 bags. Use sack-type spears to randomly draw from top, middle and bottom of bags. Place samples in sealed clean, dry, opaque, leak-proof container (such as food quality plastic jars or bags). Label samples appropriately. Avoid any factors that can affect the mycotoxin content (expose samples to excessive moisture, heat, sunlight, and cross-contamination). Store samples in a cool dark place. In retail outlets, do not remove pre-packed retail samples from their packaging. Collect enough packs to provide an aggregate sample representative of a batch/lot, i.e. do not take just one pack. Some sampling plan e.g. EU specify formula for sampling retail packs. ‘Grab’ samples have no value in estimating aflatoxin level in a lot.

SAMPLE PREPARATION - The aim of sample preparation is to prepare final sub-samples for laboratory analysis. Sample preparation involves grinding and sample division to obtain a representative analytical sample. This is best done using subsampler mill (e.g. Romer RAS mill, where the original bulk sample is ground and then subdivided; this is highly recommended. Alternatively, aggregate sample is mixed by blending and coarsely ground (about 1 mm). Then mixed thoroughly and sub-divided to obtain subsamples of about 2 Kgs. These are then finely ground to pass a standard # 20 mesh screen for laboratory analysis. Sometimes, a large aggregate sample is reduced using subsamplers such as centrifugal divider (e.g. Riffle or Gamet) or conic divider (like Boerner) to obtain subsamples of about 2kg. These are then finely ground to obtain a laboratory sample. FAO advises against utilization of these subsampling devices. It is advisable to have 1 sample for analysis and reserve 1-2 samples for probable repeat analysis and one for retention as a reference. Sample preparation procedures described in official sampling plans should as much as possible be followed.

EXTRACTION - This involves homogenization of a small amount of sample, commonly between 2-50g with organic solvents, mixtures of water/buffer s with organic solvents for about 3 minutes (blender) to 60 minutes (shaker). Older sample extraction methods employed large amounts of non-aqueous organic solvents such as chloroform, dichloromethane, ethyl acetate. Modern methods employ mixtures of water/buffer s with polar organic solvents such as methanol, acetonitrile and acetone. Older sample preparation techniques were expensive, time-consuming and more labor-intensive. Emphasis in modern times is on the minimization of solvent use, especially of

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environmentally and health-harmful chlorinated solvents. Miniaturization of the procedures, meaning also smaller sample size, while at the same time, maintaining the efficiency. Mixtures of methanol and water/buffer are the most commonly used. Other newer methods include ultrasonic extraction, Supercritical fluid extraction (SFE), microwave-assisted extraction (MAE). They require less solvent and usually they have better extraction efficiency.

Sample Clean-up and Purification - The aim is to remove non-mycotoxin "interfering" compounds whilst leaving the mycotoxins in the extract. Common clean-up techniques are defatting, column-chromatography, precipitation, liquid-liquid solid phase extraction (SPE) and immunoaffinity chromatography (IAC). IAC and SPE are most popular in recent times. Defatting is by homogenization with hexane or petroleum ether to extract lipids from the sample extract. These methods are explained below.Column chromatography – sample extract is passed through a column packed with adsorbent materials, interfering compounds washed and aflatoxins eluted with a small volume of organic solvent. Long (20cm) columns or miniature (5 cm) column are used. Precipitation- precipitating agents such as cupric carbonate, ammonium sulphate, lead acetate, and ferric gel are added to the crude extract and these absorb certain pigments, proteins and other interfering compounds to form precipitates. Precipitates can be removed by filtration or centrifugation.Liquid-liquid partition- using the two immiscible solvents where aflatoxins are preferentially partitioned into one of the solvents. This often has a considerable increase in concentration of the toxins in one solvent and interfering compounds in the other solvent.Solid-Phase Extraction – this is column chromatography using small cartridges containing adsorbent materials with great surface area to mass properties e.g. bonded silica C18 columns, florisil, ion exchange resins. Small amount of sample extract is diluted in water/buffer, passed through a small column, interfering compounds washed of and aflatoxins eluted with a small volume of organic solvent. Eluate may be applied to TLC, fluorometry, ELISA or HPLC. SPE has the advantage of rapid and economical one-step sample purification and may be used in multi-mycotoxin analysis. Columns can be stored at room temperature and have a long shelf-life. The disadvantage of SPE is that it has a variable recovery in different foods matrix. Immunoaffinity chromatography – this is similar to SPE. IAC columns contain anti-aflatoxin antibodies immobilized onto agarose gel in a small plastic cartridge. Small amount of sample extract is diluted in water/buffer, passed through a small column, interfering compounds washed off and aflatoxins eluted with a small volume of methanol or acetonitrile. Eluate may be applied to fluorometry, ELISA or HPLC. Eluates obtained are very pure. IAC purification common in HPLC methods, including multi-mycotoxin analysis. Rapid and economical one-step sample purification. Disadvantage: Columns have a short shelf-life and require cold storage.

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Methods of aflatoxin detection and quantification - Common methods are either physicochemical or immunological. Physicochemical methods include thin layer chromatography (TLC), Fluorometry and high performance liquid chromatography (HPLC). Common immunological methods include enzyme-linked immunosorbent assay (ELISA) and immunochromatographic tests.Thin layer chromatography (TLC) - minimal equipment and moderate cost. Low sensitivity, false positives, lengthy and cumbersome procedure, use of large amounts of toxic organic chemicals. One of the most widely used methods. Purified extracts are applied to planar chromatography. Qualitative or semi-quantitative estimations by visual inspection. Densitometric measurements also reliable quantitative results. Some are official AOAC methods. Two-dimensional TLC and high performance TLC (HPTLC) are efficient separation and determination of aflatoxins. Method can detect as low as 1ng/g (1ppb) aflatoxin. Disadvantage: described methods have long, time-consuming extraction procedures which employ large amounts of toxic chemicals.High performance liquid chromatography (HPLC) - Most sensitive and precise method.HPLC methods – normal phase and reverse phase HPLC methods with pre-column and post-column derivatization and fluorescence or ultraviolet detection. Also, reverse phase HPLC with electrochemical detection. Reverse phase HPLC more commonly used. Methods with IAC and HPLC most popular in recent times. These are rapid and may be automated. Problems: High equipment cost and needs an operator who is experienced.Fluorometric assayEffective and quantitative method. Method requires highly purified sample extract, usually processed by IAC or SPE. Detection and quantification of aflatoxins dependent of fluorescence of sample extract. To enhance the fluorescent signal, aflatoxins are derivatized before fluorometric measurement. Disadvantage: naturally occurring fluorescent compounds may cause interferences.Enzyme-linked immunosorbent immunoassay ( ELISA) Rapid, inexpensive test suitable for mass screening. It is a sensitive and quantitative method. Test based on ability of a specific antibody to bind aflatoxins. The direct competitive ELISA is most commonly used for mycotoxin analysis. Many commercial test kits available. Example is Ridascreen Aflatoxin test kit. Laboratory-based tests and field-based (on-site) tests are available. Disadvantages: sample matrix interference is common. Test must be validated for each sample matrix and commodity.Immunochromatographic testA type of ELISA. Also referred to as lateral flow test or test strip. Rapid, inexpensive test suitable for field use. It is a qualitative or semi-quantitative method. Many commercial test kits available. Example is RidaQuick Aflatoxin test kit. Many give results at cutoff levels; 5ppb, 10ppb, 20ppb,etc

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CONCLUSION – There are various protocol for analysis in various foods; analysis are at trace levels i.e. ppb, ppt; Most tests are published by AOAC, FAO, USDA, Codex, EU and other organizations. If these tests are correctly applied, they will yield correct results. Uncertainty of results will arise from sampling, laboratory factors (environment, equipment, level of training of analysts, method of analysis). Quality assurance of aflatoxin analysis – sampling, laboratory testing is necessary; therefore the need for sampling – which are most appropriate for the region like FAO / Codex, EU, etc. Laboratory – use of validated methods (e.g. Accuracy, precision, detection limits), internal control materials, participation in proficiency tests (suggest a regional one) and laboratory accreditation (e.g. ISO 17025); acceptance of analytical results across the region.

2.3.3Discussion

After the presentations the participants discussed the questions below; which are later summarised into the action plan in section 3.

Points for discussion

1. Is there need for risk assessment?2. Do we do epidemiological mycotoxicosis data collection as part of RA for

decision making?3. How can harmonization of related food safety standards in the region be

done?4. Do we need economic impact assessment to influence policy?5. Do your countries HAVE sampling plans that have been developed?6. Do we need a regional laboratory that can do proficiency testing?

2.4 Mycotoxin regulatory limits

2.4.1Overview of mycotoxin regulation worldwide

Dr. James Muthomi of University of Nairobi took participants through the presentation above; this is detailed below.

The Need for Harmonized Mycotoxin Regulation 1. To protect the consumer from the effects of mycotoxins to ensure a safe

supply of food and feed2. Various legislative measures are yet to be harmonised among countries.

The codex Alimentarius Commission is making efforts to establish international levels for mycotoxins, and aflatoxins in particular.

3. Official monitoring of mycotoxin contamination in the developing world, especially in the sub-Saharan Africa is rare

4. Facilitate trade through elimination of “harsh” limits that act as barriers to trade

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Examples of food commodities and aflatoxin contamination levels in Africa

Country

Commodity

Frequency of aflatoxin positive samples

Contamination rate/concentration

Reference

Botswana

Raw peanut

78% contained aflatoxins

Concentrations ranging 12-329 mg/kg

Barro et al., 2002

Nigeria Pre-harvest maizeDried yam chipsMelon seeds

Aspergillus flavus was isolated from 65% of samples

Total aflatoxins ranged 3-138 mg/kg in positive samplesMean concentration of aflatoxin B1: 27.1 ppb.Aflatoxin B1 above 5 mg/kg in 32.2% of samples

Maxwell et al., 2000 Chauliac et al., 1998 Mensah et al., 2002

Senegal Peanut oil Aflatoxin B1 found in over 85% of samples

Mean contents about 40ppb

Muleta and Ashenafi, 2001

S. Africa Traditionally brewed beers

33.3% of commercial beer samples contained aflatoxins

200 and 400 mg/l Mensah et al., 1999

Kenya Maize Samples from local marketsSamples from government ware houses350 maize products

Up to 46,400mg/kgUp to 1,800mg/kg55% had levels >20ppb; 35% had levels >100ppb;

CDC, 2004 CDC, 2004 Lewis et al., 2005

Overview of mycotoxin regulations 1. Human foods are allowed 4 – 30 ppb aflatoxin, depending on the country

involved. In the US, 20 µg/kg is the maximum aflatoxin residue limit allowed in food for human consumption, except for milk.

2. In the EU, 4 µg/kg total aflatoxin in food for human consumption are the maximum acceptable limits, the strictest in standard worldwide.

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3. 100 ng/kg body weight provisional tolerable weekly intake (PTWI) of OTA has been established.

4. The European Union (EU) introduced lower maximum tolerated limits for several mycotoxins in food and feed which became effective from 1st

October 2006.

Factors affecting the constitution of mycotoxin regulations

1. Availability of toxicological data2. Availability of data on the occurrence of mycotoxins in various

commodities3. Knowledge of the distribution of mycotoxin concentrations within a lot4. Availability of analytical methods5. Legislation in countries with which trade contacts exist6. Need for sufficient food supply

Considerations in Risk Assessment 1. Hazard identification and hazard characterization - known toxic effects2. Exposure assessment - reliable data on occurrence and food intake 3. Sampling procedures – should capture distribution of the concentration

of mycotoxins in products 4. Methods of analysis – should be reliable to make enforcement of the

regulations possible. Demonstrated in inter-laboratory validation studies. E.g. Association of Official Analytical Chemists (AOAC International) and the European Standardization Committee (CEN)

5. Trade contacts – regulations should be harmony with those in force in other countries with which trade contacts exist. Strict regulative actions may act as barriers to trade

6. Food supply - strict legal measures may lead to lack of food and excessive prices

East African Community maximum quality limits for maizeGrade 1 Grade 2

Foreign matter, % 0.5 1.0Inorganic matter, % 0.25 0.5Broken grain, % 2.0 4.0Pest damaged grain, % 1.0 3.0Rotten and diseased grain, % 2.0 4.0Discoloured grain, % 0.5 1.0Moisture, % 13.5 13.5Immature/ shrivelled grain, % 1.0 2.0Filth, % 0.1 0.1Aflatoxins (ISO 16050) 10ppb, 5ppb AFB1 10ppb, 5ppb AFB1Total defective grain, % 4.0 5.0

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Maximum Mycotoxin Regulatory Limits (ppb) Commodity / use Mycotoxin FDA EU Code

x Kenya

Milk and milk products Aflatoxin M1 0.5 0.05 0.5 Maize (food) Aflatoxin B1 20 2 15 5 Maize (food) Total

aflatoxins 20 4 - 10

Maize (food) Fumonisins 4000 2000 - Maize products (food) Fumonisins 2000 1000 - - Cereals and cereal products (feed)

Fumonisins 5000 – 100,000

60,000 - -

Maize (Feed) Aflatoxins 100 - 300

20 -- -

Raw cereal grains (food)

Ochratoxin A - 3 – 5 - -

Unprocessed maize(food)

Deoxynivalenol

- 1750 - -

Cereal flour (food) Deoxynivalenol

1000 750 - -

Cereals and cereal products (feed)

Deoxynivalenol

- 8000 - -

Maize by-products (feed)

- 12,000 - -

Unprocessed maize(food)

Zearalenone - 200 - -

Maize products (food) Zearalenone - 200 - -

Maximum Mycotoxin Regulatory Limits – South AfricaMycotoxin Maximum limit Product Total aflatoxins 10 ppb All foodstuffsAflatoxin B1 5 ppb All food stuffsAflatoxin M1 0.05 ppb Milk & milk productsPatulin 50 ppb Apple juice, juicesDeoxynivalenol (DON)

750 ppb Maize, wheat flours

Ochratoxin A 5 ppb CerealsFumonisins 1,000 ppb (Provisional

Maximum Tolerable Daily Intake – PMTDI of

Maize, maize-based raw materials

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2µg/kg/bw/day)

Maximum tolerated aflatoxin levels (mg/kg) in 1995 and 2003

1995 2003 aflatoxin/matrix combination

median (mg/kg)

range (mg/kg)

No. of countries

median (mg/kg)

range (mg/kg)

No. Of Countries

Afla B1 in foodstuffs

4 0-30 33 5 1-20 61

Afla B1+B2+G1+G2 in foodstuffs

8 0-50 48 10 0-35 76

Afla M1 in milk

0.05 0-1 17 0.05 0.05-15 60

Afla B1 in feedstuffs

5 5-50 25 5 5-50 39

Afla B1+B2+G1+G2 in feedstuffs

20 0-1 000 17 20 0-50 21

Mycotoxins regulated in food in Africa

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Mycotoxins regulated in food in Europe

Worldwide limits for total aflatoxins in food

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Worldwide limits for aflatoxin B1 in food

Worldwide limits for aflatoxin M1 in milk

Worldwide limits for ochratoxin A in cereals and cereal products

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Worldwide limits for deoxynivalenol in wheat (flour) and other cereals

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Worldwide limits for zearalenone in maize and other cereals

Worldwide limits for fumonisins in maize

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Difficulties in implementing mycotoxin regulations 1. Widely varying standards among different national or multilateral

agencies - balance between addressing food safety concerns and limiting disruptions of trade

2. Application of regulatory limits in developing countries is difficult because of prominence of subsistence farming and food scarcity. Consequently, more than 5 billion people in developing countries worldwide are at risk of chronic exposure to aflatoxins through contaminated foods

3. Enforcing regulatory limits naturally imposes costs on domestic producers and consumers leading to higher consumer prices

4. Divergent standards may affect producers in other countries, disrupt trade, and result in trade disputes

5. Exceptionally strict food safety regulations impose unfair economic and safety burdens on lower income food-exporting countries. Such standards limit export opportunities because compliance is too costly or unachievable given the lack of technical capacity, infrastructure, and experience with food hazards management

2.4.2Application of biocontrol in managing aflatoxin in Africa: the case of Aflasafe

Dr. Mutegi, C. K of International Institute of Tropical Agriculture (IITA) took participants through the presentation above; this is detailed below.

Principles of Aflatoxin Biological Control is based on fungal communities differ in aflatoxin-producing ability; some strains produce aflatoxin (toxigenic) and others no aflatoxin (atoxigenic). There is competitive exclusion (one strain competing to exclude another); shift strain profile from toxigenic to atoxigenic; application is 2-3 weeks before flowering; Thus, aflatoxin contamination reduced (contamination starts in the field); we identify and promote only native beneficial strains.

Steps in Aflatoxin Biocontrol include: 1. Collection and identification of isolates (Characterization of isolates, Identification of native atoxigenic strains and determination of genetic and molecular diversity in the atoxigenic strains); 2. Ensuring biosafety of the atoxigenics; 3. Testing efficacy of atoxigenics in field trials; 4. Registration of the atoxigenic strains as biopesticides; 5. Up scaling and out scaling to wider areas; 6. Sensitization of growers, consumers and regulatory agencies about potential of biocontrol.

For a biocontrol agent to be successful: They need to be of wide occurrence in nature in Kenya i.e. widely distributed in various locations; have ability to colonize multiple substrates; have ability to be recovered naturally across years; have ability to move from the soil and colonize grain

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(strain recovery); have efficacy in displacing toxigenic fungi and thereby reduce levels of aflatoxins; and have the inability to produce aflatoxin due to inherent defects in aflatoxin biosynthesis genes.

The history of biocontrol of aflatoxins in Kenya shows: between 2004 to 2006, grain and soil samples were collected by CDC, Ministry of Health and ICIPE where Aspergillus population structure studied in USDA-ARS and biological basis (S-strain) of high toxin production were discovered; in between 2007 to 2010, several Kenyan atoxigenic strains were identified and 13 highly competitive atoxigenic isolates selected based on laboratory studies; in July of 2010, the USDA-FAS provided funding for further exploring the utility of the atoxigenic strains in aflatoxin biocontrol in Kenya and training Kenyan staff and infrastructure development; in Oct 2010 the AATF provided complementary funding to KARI and IITA, but in between Sep and Nov 2010 an application was made to KSTCIE for repatriation of Kenyan atoxigenic strains. It is important to involve all key players from the very beginning! In Dec of 2010 the KSTCIE approved strain repatriation, the import permit was issued, inoculum multiplied in IITA-Ibadan and shipped to Kenya. Please note that time; need to build local capacity–human capacity and infrastructure. In between Dec 2010 and February 2011, field plots in KARI-Katumani, Kiboko and Bura were inoculated with 13 atoxigenic strains under confined trials; the purpose was to identify 4-6 highly competitive strains under field conditions in Kenya that would constitute a biocontrol product. The inspection of trials is done by KSTCIE – a risk analysis group comprising Ministry of Agriculture, MPHS, NEMA, PCPB and KARI at critical stages like field selection; planting; soil sampling and inoculation; harvesting; shipping of samples for further analysis where a phytosanitary certificate is issued. On reaching the US-for further analysis, clearance was by APHIS at point of entry, where they require a phytosanitary certificate by KEPHIS; a well labelled product; importation permit from US; double pack! This was followed by further laboratory analysis in the USDA labs. The production of inoculum is currently being done at IITA Nigeria which will be shipped back to Kenya for field application.

The next steps include: Ecotoxicological and toxicological data to be gathered for the six strains; further confined trials to be done with the six strains; then move on-farm for further efficacy trials; apply for an experimental use permit to PCPB (www.pcpb.or.ke) for application forms; required to test product at 3 levels/rates; registration and commercialization aspects of the product; it takes about 3 years before a registered product can be attained. There are possibilities of regional harmonization as the same strains are across administrative boundaries; there is need to rationalize experimentation procedures right now as regulations in countries where biocontrol has been done are varied while in other countries they do not exist; there is need to develop local capacity from both sides (research

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and regulation); there is need to invest in laboratory services to reduce time and develop local capacity i.e. microbial and chemical laboratory.

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Focus of countries and stages of biocontrol product development:

Country Strain identification

Partnerships Commercialization Capacity development

Kenya Nigeria Senegal Burkina Faso Ghana Ivory Coast Malawi Mozambique Ethiopia Zambia Mali Starting Uganda Starting Tanzania Starting

Worldwide the registered products are based on the technology in US with products such as Aflaguard and AF36; while in Nigeria there is AflasafeTM

which has provisional registration; in Kenya there is Aflasafe KE1 a trademark being registered for eventual product; Intellectual property (IP) issues being handled by African Agricultural Technology Foundation (AATF).

In conclusion there is need to recognise for those wishing to register biocontrols the key bodies involved in regulation and registration are KSTCIE, KEPHIS and PCPB; biocontrol is not a silver bullet to management of aflatoxins hence there is need for an integrated approach for mycotoxin management as contamination is throughout the food chain.

2.4.3Registration and Certification Guidelines for Biocontrol Agents (Biopesticides, Biofertilizers, Bioexclusion Agents)

Dr. Esther Kimani of KEPHIS took participants through the presentation above; this is detailed below.

Objectives of the Biocontrols Registration guidelines are - Protect human and animal health; Facilitate trade in agriculture input and produce; Security from emerging threats to agriculture and environment

Guidelines for registration - The following considerations are made: Products safety, Quality and economic value; and Technical information summarized in a label

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Procedure for Registration in Kenya - Apply for introduction of a new pest control product; A copy of dossier of technical information; A sample of pest control product; Introduction fee is charged; Experimental permit issued for local biological efficacy trials by researchers or institutions accredited by PBPB to do trials; Researcher provide confidential report; Dossier discussed by registration committee; Applicant provides proposed commercial label; (application rate, timing and local recommendation). Product registered for 3 years if the board is satisfied (safety, efficacy , quality and economic value) and a certificate of registration issued; There after renewable after every 2 years; Temporary registration for one year -To provide additional information, Emergency control of harmful infestations; Suspension of certificate of registration - False information on application, New information indicate that the product is unsafe

Rejection of application for Registration - Label on the product is not compliant with the stipulated provisions; Insufficient information to facilitate proper assessment and evaluation; The applicant fails to establish product value when used as per the label; Use product would lead to unacceptable risks to human, animal, plants and environment in which the product is intended to be used; (Cap 346 provide guidelines for PCPB)

Timeframe: Dependent on a number of factors - Completeness of the submitted dossier and application package; Excess delay in submitting data requested; The proposed uses and timing of seasons; Failure to appoint local agent; Delay in submitting experimental samples and remitting funds to testing institutions; (depending on product and use 1 to 4 years); pcpbboard@todays.co.ke, for more information

KSTCIE applications - Kenya Standing Technical Committee for Import and Exports; KSTCIE is Risk Analysis Committee; Scope include: Biological control agents capable of self-replication, parasitoids, predators, parasites, nematodes, phytophagous organisms, pathogens such as fungi, bacteria and viruses, Insects, sterile insects, beneficial organisms: e.g. mycorrhizae and pollinators, Microoganisms: packaged or formulated as commercial products; Regulate introductions – Research, Commercialization, trials

KSTCIE Committee includes Ministry of Agriculture-Chair, KEPHIS-Secretariat, and Members: PCPB, KARI, DVS, MPHS, NEMA, NMK and others; Legal framework - Laws of Kenya guide operation of specific institutions, Guidelines of WTO SPS agreement, International laws e.g. ISPM No.3 `Guidelines for the export, shipment, import and release of biological control agents and other beneficial organisms (2005)` - IPPC; KEPHIS - guided by Crop Protection Act Cap 324.

Role of KSTCIE Committee includes: facilitate safe import, shipment and release of biological control agents and other organisms through risk

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assessment; providing recommendations for approval that address the safe handling, assessment and use of the organisms or products containing organisms while implementing appropriate sanitary and phytosanitary measures under existing regulations; encouraging responsible trade practices.Ministry of Agriculture provides policy direction though the Chairman i.e. Agriculture Secretary; the Secretariat is Kenya Plant Health Inspectorate Service (KEPHIS);

Roles of KEPHIS include: to receive applications on behalf of the MoA; Evaluate application documentation to ensure all requirements for risk assessment are provided (Annex1; Guidelines for Risk Assessment of BCAs and related products-©KEPHIS); Review and distribute submitted documentation to relevant member institutions and technical experts for risk evaluation; Maintain communication between applicant and reviewers until all concerns are addressed; Co-ordinate the preparation of KSTCIE Committee meeting(s)

Role of Member Institutions include: Evaluate applications submitted for review and provide informed comments and recommendations; Attend, deliberate and establish recommendations for approvals for applications scheduled in KSTCIE committee meeting(s); Participate in monitoring the execution of the approval/ recommendations as required e.g. Monitor trial activities, evaluate trial findings,

Inspection & Monitoring Activities: Generate a monitoring plan together with applicant (Relevant institution led by KEPHIS); Inspection and certification of containment/confinement facilities (led by the KEPHIS); Issuance of Import Permit based on the approval conditions in addition; other import conditions with regards to phytosanitary requirements for the respective material (KEPHIS) also considered; Co-ordinate and execute monitoring activities as per monitoring plan (Relevant institution led by KEPHIS); Research findings are reported back to KSTCIE Committee

Aflatoxin control-application discussed in KSTCIE meeting in Oct 2010: Recommendations: Approval granted for experiments to be done under laboratory, greenhouse and field conditions in the 7 sites; A KSTCIE sub- committee comprising of Ministry of Public Health, KEPHIS, KARI, PCPB and Ministry of Agriculture was formed to approve the quarantine sites and monitor the trials; Monitoring activities ongoing; Sampling process ongoing- obtained samples for comparable testing by KEPHIS, Government Chemist / Laboratory and Kenya Bureau of Standards (KEBS); The results will be used to authenticate results provided by AATF at the conclusion of the trial process. After KSTCIE: Pesticide Control Products Board-PCPB, Ministry of Health and Sanitation and Kenya Bureau of Standards (KEBS); on bio-

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exclusion may be applicable? At National level (for movement control and border inspection), during production and marketing

Roles: There is need for collaboration as no single agency or organization has both the legal authority and a sufficient level of resources to conduct an effective mitigation to protect human, animal and plant health and life without the involvement and support of others; therefore, the need to bring together relevant public and private sector players; and the relevant skills and expertise are required in developing and implementing effective mitigation activities, to Protect Human, Animal and Plant Health. The role of Government include providing political commitment which is essential; to develop, finance, implement and enforce regulatory measures; to bring stakeholders together; to provide information. While the role of private sector are to invest responsibility and implement safely; to provide premises, methods and tools; to provide communication, awareness, information and training. The role of International and Regional Organizations are: to facilitate; method, tool, norm and strategy setting; assessment and monitoring impacts

Some the challenges include: the need to stimulate voluntary compliance; only large companies driven to invest by consumer pressure, global market chains; only large companies provide information; difficulties at the small holder/village level

2.4.4Discussion

After the presentations the participants discussed the questions below; which are later summarised into the action plan in section 3.

Points for discussion

1. To what extent do mycotoxin hazards and regulations affect international trade and what are the economic costs?

2. What steps can be taken to mitigate trade disruptions?3. What would be the advantages and disadvantages of harmonized

mycotoxin legislation in the COMESA?4. List the key players who would be important in regulating biocontrols,

biofertilizers and biopesticides 5. Why is it important to regulate bio controls, biofertilizers and

biopesticides 6. What is the role of scientists in regulation of biocontrols, biofertilizers

and biopesticides 7. What are the capacity needs for handling aflatoxin biocontrol research

and regulation in your countries8. Do you have biocontrol registration and regulation guidelines? 9. Any challenges in biocontrol regulation/registration/research?

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2.5 Closing session

The closing session was honoured to have Ms. Franscisca from USAID; the MD KEPHIS closed the function and handed over certificates plus a CD with the training material used during the course.

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2.6 Pictorials

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3. Way forward and Regional Action Plan

Ms Martha Byanyima, SPS Expert, COMESA Secretariat facilitated countries to develop the regional action plan;

Specific Objective 1 - Regionally harmonized Food Safety Systems for Aflatoxin Control

Specific Objective 2 – Regionally harmonized regulatory framework for aflatoxin biocontrolsOutcome Participating

countriesHow/describe proposed country activities

Name and address of Laboratory

Facilitator e.g. COMESA with support from USDA

Specific Objective 1 - Regionally harmonized Food Safety Systems for Aflatoxin Control1.1Regionally

harmonised aflatoxin limits

National laboratories, address as

above

Adopt EAC limit of 10ppb

1. Chitedze Mycotoxins Laboratory – Department of Agricultural Research Services, P.O. Box 158, Lilongwe. Malawi.

2. Uganda National Bureau of Standards, P.O. Box 6329, Kampala. Uganda.

3. Mycotoxins Laboratory, Department of Agriculture, Malkerns Research Station, P.O. Box 4, Malkerns. Swaziland.

1.1 COMESA and EAC, facilitated by USDA

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4. Mrs. Eman Hamed Toren, Chemical Analyzer, Sudanese Standard and Metrology Organization, Khartoum, Sudan. Tel: +249908777982

5. Public Health Laboratory, Victoria-Mahe, Seychelles.

6. Food Technology Laboratory, Ministry of Agro-Industry & Food Security, Reduit, Mauritius.

7. Kenya Bureau of Standards, P.O. Box 54974-00200, Nairobi. Kenya.

8. Microbiology Laboratory, Zambia Agriculture Research Institute, Private BagChilanga. Zambia.

9. Chemical and

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Microbiology Laboratory, Cairo-Egypt. Tel: +20124265980/ +201000305079

1.2 Regionally harmonised sampling plans

National laboratories, address as above

Benchmark procedures against established internationally recognised plans e.g. EU, Codex

As above COMESA and EAC, supported by USDA

1.3 Regionally harmonised aflatoxin testing procedures and quality systems in laboratories

National laboratories, address as above

National laboratories, address as above

COMESA and EAC, supported by USDA

1.4Capacity strengthening

National laboratories, address as above

(a)Training for laboratory analysts on sampling and testing procedures

(b) conduct proficiency testing

a) In country workshops b) collaboration with the Joint Institute of Food Safety & Applied Nutrition/University of Marylandc) collaboration with the United States Department of Agriculture (USDA)

COMESA, supported by USDA and JIFSAN

Specific Objective 2 – Regionally harmonized regulatory framework for aflatoxin biocontrols2.1 Regionally

harmonised importation / repatriation guidelines for bio-controls

All Establish technical committees in respective countries

Review /learn from the Kenya

focal point to be identified by member state 2.1

COMESA, national technical committees, with support

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model from USDA2.2Regionally

harmonized registration guidelines for bio-controls

All Establish technical committees in respective countriesSupport technical committee to establish registration guidelines, Review /improve the Kenya model

focal point to be identified by member state

2.2 COMESA, national technical committees, with support from USDA

2.3. Capacity strengthening

All Target aflatoxin biocontrol laboratories

collaboration with the United States Department of Agriculture (USD)

focal point to be identified by member state

2.3 COMESA, national technical committees, with support from USDA

Annex 1: Training programme

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29th February 2012Session four: Mycotoxin regulatory limits

15 8:30 Overview of mycotoxin regulation worldwide

Dr. James Muthomi (Univ. of Nairobi)

16 9:15 Harmonization of mycotoxin regulation and standards in the region

Group discussion

17 10:00 Tea Session five: Registration guidelines for bio controls

18 10:30 Application of biocontrol in managing aflatoxin in Africa: the case of Aflasafe

Dr. Charity Mutegi (IITA)

19 11:45 Registration and certification guidelines for Biocontrol agents (Biopesticides, Biofertilizers, Bioexclusion agents)

Abed Kagundu / Dr. Esther Kimani (KEPHIS)

20 13:00 Lunch21 14:00 Harmonization of registration and

certification proceduresGroup discussion

22 15:00 A regional action plan on harmonization of sampling, testing, mycotoxin regulatory limits / standards, registration and certification procedures.

Ms. Martha Byanyima (SPS Expert, COMESA)

23 15:30 TeaClosing session - MC, Dr. Esther Kimani, GM-Phytosanitary services, KEPHIS24 16:00 A regional action plan on harmonization of

sampling, testing, mycotoxin regulatory limits / standards, registration and certification procedures.

Ms. Martha Byanyima (SPS Expert, COMESA)

25 16.15 Closing remarks USAID representative, Franscisca

26 16.30 Official closure – Certificate of attendance, CD of all training materials to all participants

Dr. James Onsando, (MD-KEPHIS)

27 17:00 End of program1st March 2012

28 Departure Harriet N. Malindi (COMESA) / Dinah Murungi (KEPHIS)

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Annex 2: Official opening statement

BY THE PERMANENT SECRETARY, MINSTRY OF TRADE

ENG. ABDULRAZAQ ADAN ALI, CBS28th February 2012

Managing Director, KEPHISDistinguished Delegates Officials from the COMESA SecretariatLadies and Gentlemen

On behalf of the Kenya Government, I take this opportunity to welcome you all to Nairobi, I realize you have a tight two-day schedule, but I hope you will find time to tour the city and some of our tourist sites that are close by.

I feel greatly honored to open this training because aflatoxin contamination has become a burden to the Kenyan economy; grossly affecting trade and public health as has been the case in Eastern Kenya quite recently.

Globally, it is estimated that 25% of world food crops especially maize, peanuts, cassava is affected by aflatoxin contamination. These crops constitute the staple food for majority of African countries and in a country like Kenya this undermines the overall development goals of the government. Aflatoxin is a multi-faceted trans-boundary problem that requires a holistic approach involving public and private stakeholder participation, a sector-wide approach, regional and international collaboration and new approaches such as the use of bio control technologies that have been successful in other parts of the world like USA.

Kenya is privileged to host this training for two reasons:First, in the last decade, the country has had several outbreaks of aflatoxin poisoning that caused serious illnesses and several deaths. This meeting is an opportunity for us to share knowledge and experiences with regional trade partners as we explore the most effective strategies to address the problem. With respect to aflatoxin control, the Kenya Government has embraced integrated management strategies combining food safety controls and public awareness campaigns with biological technology to suppress the fungal infection, while placing strong emphasis on technology transfer and awareness creation. This has been highly participatory, spearheaded by the Kenya Agriculture Research Institute (KARI). Our experience is that integrated management strategies are effective in controlling aflatoxin contamination.

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The second reason is that the COMESA region has made good progress on economic integration and intra regional trade. The launch of the Free Trade Area in the year 2000 and the Customs Union three years back (on 7 th

June 2009) is evidence of the effort we have all painstakingly put together towards an economically integrated region. Today, intra regional trade is well over US$17 billion and is still growing. There is evidence that volumes of trade within the region are growing versus the rest of the world. This is not happening by accident; it is because of an improved business and investment environment that we have all contributed to as COMESA member states.

However, it is important to note that this transformation has largely been based on tariff reduction and elimination. Non tariff barriers (NTBs) persist, even as we make great strides in harmonizing internal and external tariffs. Food safety policies, legislation and regulatory frameworks, including aflatoxin control systems, which are key to the competitiveness of regionally traded commodities/products, are NTBs that are technical in nature, and have persisted in the midst of a growing common market. From Kenya to Zambia to Malawi and South Africa, there has been cases of contaminated grain and peanuts confiscated and destroyed at borders because of certificates of analysis that are not trusted. It is important to note that the most affected are the small scale producers and traders whose livelihoods depend on cross border trade. Therefore, the absence of harmonized regulatory systems for aflatoxin control is undermining the gains we have made on economic integration.

Distinguished Ladies and Gentlemen,I view this meeting as an opportunity for national experts to discuss and agree on the most acceptable sampling and testing procedures to be adopted by regional laboratories. This will facilitate cross border traders in a significant way as certificates of analysis will no longer be rejected when laboratory procedures are the same in every country.

In addition, while there is evidence that bio control technology is effective, there is need for harmonized regulatory frameworks for importation and repatriation of samples. Kenya has made good progress on this and is ready to share lessons with other countries, particularly, Malawi and Zambia which have embarked on trials. Also, it is important to emphasize the need for regionally harmonized bio control registration guidelines. This will encourage investments, commercialization and scaling up use of the technology regionally. The existing regulatory environment in majority of COMESA countries, is tailored for agrochemicals, and does not suit natural remedies such as bio-controls

Distinguished Delegated, Ladies and Gentlemen,

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This meeting is an opportunity for us to agree on regional actions for a harmonized approach that will facilitate intra regional trade in aflatoxin sensitive foods. Apart from trade, aflatoxin exposure is strongly associated with nutritional deficiencies that lead to stunting in children, anemia in pregnant women and liver cancer in adults. There is published evidence correlating these relationships. With this evidence, we cannot wait to act; we must act now. I have no doubt that together we can take collective action in addressing this challenge.

In concluding my remarks, allow me distinguished delegates, ladies and gentlemen, to extend my heartfelt thanks to the COMESA Secretariat for facilitating this training. It is my hope, that we will have another convening to take stock of our achievements in this respect and review our next actions.

Once again, I welcome you to Kenya and wish you very fruitful deliberations and outcomes.

I thank you all for listening.

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Annex 3: Welcoming Remarks

Welcoming remarks by Managing Director, KEPHIS, Dr. James M. Onsando

Welcomed everyone to KEPHIS and acknowledged presence of

PS-Trade, Eng. Abdulrazaq Adan Ali, CBS COMESA Representative Delegates from COMESA members countries – Malawi, Egypt, Uganda,

Swaziland, Mauritius, Zimbabwe, Zambia, Sudan, Burundi, Comoros, Madagascar, Congo DRC, Seychelles and host country Kenya.

Ladies and gentlemen

Importance of the training

The importance of mycotoxins in Africa - a food safety concern : Illustrated by the high levels of certain types of cancer, e.g.

hepatocellular carcinoma, which is a common type of liver cancer; Frequent rejections of regional groundnut exports to the EU and

South Africa; Available research and evidence points to recurring outbreaks of

aflatoxin contamination in some COMESA countries that have caused death, serious illnesses and interrupted trade.

Milestones achieved in the control of Aflatoxin in Africa/COMESA

As a result, governments and donors have stepped up efforts to address the aflatoxin problem in a coherent and integrated manner, like the 7th Comprehensive Africa Agriculture Development Programme Partnership Programme (CAADP-PP) held in Yaoundé March 2011, endorsed the decision to establish an African led partnership for aflatoxin control (PACA) within the CAADP framework to mobilise resources and ensure effective coordination of the various actors engaged in addressing the aflatoxin problem at national, regional and continental levels.

COMESA has actively engaged in the initial stages of conceiving PACA and subsequent endorsement at the 7th CAADP-PP. In an effort to coordinate regional effort, the COMESA SPS programme has articulated interventions that require collective action by member states.

Kenya’s role in Aflatoxin control, challenges and management

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As the government regulatory agency dealing in SPS measures, we realize that Aflatoxin control and management is a multi-faceted regional and international problem that requires:

Monitoring of aflatoxin through sampling and testing of grains; including Early warning systems and monitoring.

Training of staff and awareness creation about the gravity of the problem

Availing necessary equipment like Moisture metres. Enhancing linkages with relevant stakeholders and government

departments. Mainstreaming in National policies and programs, for instance

Agricultural Sector Development Strategy (ASDS). Mobilization of resources and investment in projects with direct impact

on food quality and access to markets. Information exchange to avoid reshipment of rejected contaminated

food from one member country to another. Need for Risk Assessment and revision of tolerances if need be.

Looking forward

Integrated approach, from farm to fork (HACCP)which will limit the risks of aflatoxin contamination at each step along the food chain

Concerted efforts of all actors along the food production chain government authorities, Private sector (farmers, industries),research institutes, NGOs, …

Conclusion

Emphasize the importance of the training: that of enhancing Africa’s national and international regulatory systems to protect human health especially as regards aflatoxin control.

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Annex 4: Example of a food safety notification linked to aflatoxin by the UK

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Annex 5: Participants list

LIST OF PARTICIPANTS FOR THE COMESA REGIONAL TRAINING ON REGIONALLY HARMONIZED SAMPLING AND LABORATORY PROCEDURES FOR AFLATOXIN CONTROL, 28—29 FEBRUARY 2012, KEPHIS, NAIROBI — KENYA

BURUNDI Mr. MASUMBUKO Apollinaire, Directeur du Centre National de Technologie Alimentaire (CNTA) Ministere de I’Agriculture et de l’Elevage, B.P: 557 Bujumbura, BURUNDI Tel: +257 76 732 6421/ +257 77 732 642, Email: apolmasu2006@yahoo.frCOMOROS Dr. Abdoulkarim Mohamed, Directeur de l’Ecole do Medecine et de sante public Ministere’s de Ia santé/Ministere de I’education National. B.P 883, Tel: 269 3330025, Email: abdoulkarim_mohamed@yahoo.fr CONGO DRCMr. Kompany Khmeka Alain, Expert, Chef de Bureau.cooperation internationale regionale, Cooperation internationale et regionale, Tel: 0818843582, Email: alain_kompany@yahoo.fr

EGYPT Mr. Mohamed Mahmoud Sharaf Eldin, Technical Manager of Chemical and Microbiology Labs, General organization of import and export control, Cairo Airport, Tel: +20124265980/+201000305079, Email: sharaf1110@yahoo.com

MADAGASCAR Mr. Tosy Ramahafangoza Vaillant, Technician of laboratory Ministry of Trade, lllC38 Mahamasina, Tel:261 341222249, Email:tosyvailantyahoo.com/vaillant2404gmail.com

MALAWI Mr. Limbikani Matumba, Scientist (Mycotoxin), Ministry of Agriculture, Department of Agriculture, Research Services, Box 158, Lilongwe, Tel:+265999682549, Fax:+265707041, Email: alimbikani@gmail.com

MAURITIUS Ms. Hemlata Dowlut, Scientific Officer, Ministry of Agro Industry and Food Security, Ministry of Agro-lndustry and Food Security, Agricultural Chemistry Division, Reduit, Mauritius, Tel: +2304661435, Email: hdowlut@mail.gov.mu SEYCHELLES

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Mr. Gary Sifflore, Laboratory Technician, Ministry of Health (Public Health Laboratory), Belombre, Mahe, Seychelles, Tel: +248247928, Email: Gsifflore@yahoo.com

SUDAN Ms. Ekhlas Mohmed Alamin, Deputy Manager-COMESA Unit, Ministry of Trade, P.O. Box 249194, Tel: +249908904166/249912294729, Email: ekhlasalamin@yahoo.com Mrs. Eman Hamed Toafn, Chemical Analyzer, Sudanese Standard and Metrology, Tel:+249908777982, Email: emem73to@yahoo.com

SWAZILAND Mr Ronnie Nsibande, Mycotoxin Analyst, Ministry of Agriculture, Malkerns Research Station, TeL268 25274074, Fax: 268 25274070, Email: flsibaflderon@yahoo.com

UGANDA Mr. Iberet Joseph, Analyst, Uganda National Bureau of Standards, P.O. Box 6329, Kampala, Email: Joseph.iberet@unbs.go.ug

ZAMBIA Mr. Howard Tembo, Senior Agriculture Research Officer, Ministry of Agriculture and Livestock/ZARl, Private Bag 7, Chilanga, TeI:+260211278655/+260977805782, Fax:+260211278131, Email: tembohoward@yahoo.co.uk

ZIMBABWE Ms. Charity Tawanda Kunaka, Research Officer, Ministry of Agriculture, P0 Box CY5SO, Causeway, Harare, Tel: 04 704541, Email: csakuhuni@gmail.com

KENYA Eng. Abdulrazaq Adan Ali, CBS, Permanent Secretary, Ministry of Trade, P0 Box 30430-00100 Nairobi, Tei:+25420315001, Email: ps@trade.go.ke Dr. James Onsando, Managing Director, KEPHIS/Ministry of AgricuIture, P.O. Box 49592-00100, Nairobi, TeI:+254203536171/172, Fax: +254203536175, Email: director@kephis.orgMr. Joseph Kigamwa, Project Officer, KEPHIS/Ministry of Agriculture P.O. Box 49592-00100, Nairobi, TeI:+254203536171/172 Ext.233, Fax: +254203536175, Email: jkigamwa@kephis.org Mr. Onjolo Samuel Omolo, Assistant Manager, Kenya Bureau of Standards, P 0 Box 54974- 00200 Nairobi, Tel.0722315165, Fax:254 02604031, Email: onjolos@kebs.org Ms. Luiza Munyua, Coordinator Projects, Ministry of Agriculture/KEPHIS, P 0 Box 49592-00100 Nairobi, Tel: 0733802041, Email: director@kephis.org / lmunyua@kephis.org

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Dr. Charity Mutegi, Kenya Country Coordinator- AFLASAFE Project, International Institute of Tropical Agriculture, Ministry of Agriculture, P0 Box 30709, Nairobi, Tel:254 20 4223734/731670911/722670910, Email: c.mutegi@cgiar.org Mr. Thomas Athoo, Quality Assurance Officer, KEBS, P.O. Box 54974-00200 Nairobi, Tel : +254724387323, Email: thomasathoo@gmail.com Ms. Rosemary Nganga, Chief Analytical Chemist, KEPHIS, P.O. Box 49592 Nairobi, Tel: +254 721305812, Fax: +254203536175, Email: rnganga@kephis.orgMr. Robert K. Ngeno, Analytical Chemist, Kenya Plant Health Inspectorate Service, P.O. Box 49592-00100, Nairobi, Tel: +254726916475, Email: rngeno@kephis.orgDr James W. Muthomi, Lecturer, University of Nairobi, P.O. Box 30197 Nairobi, Tel: 254 0722984179, Email: james_wanjohi@yahoo.com Dr. James K Gathumbi, Lecturer, University of Nairobi, P.O. Box 29053-00625 Nairobi, Tel: +2540722434001/0202089728, Email: jkgathumbi@uonbi.ac.keMr. Onesmus Kyalo Mwaniki, Chemist, Kenya Plant Health Inspectorate Service, P.O. Box 49592- 00100 Nairobi, Tel :254726787542, Email: omwaniki@kephis.org Catherine Mwaguri, Public Relations and Communications Officer, KEPHIS/Ministry of Agriculture, Tel :+254729154498, EmaiI: cmuraguri@kephis.org

INTERPRETORS C.K Sokpor-Dufe, Conference Interpreter, lnterungua Consultants, P 0 Box 2581-00200 Nairobi, Tel: 254 722707165, Email: klemdufe@yahoo.comBenoit Mugenzi, Interpreter, lnterlingua, P0 Box 61544-00-200, Tel: 0728596407, Email: mugenzi.ben@gmail.comButarama Martin, Interpreter, lnterlingua, P 0 Box 61544-00-200, Tel: 254 715961447, Email: martin.butarama@gmail.com

COMESA SECRETARIAT COMESA Centre, P.O. Box 30051, 10101, Ben Bella Road, Lusaka, Zambia, Tel: 229725132, Fax: 225107, Email: secgencomesa.int, Website: www.comesa.intMs. Martha Byanyima, SPS Expert, P 0 Box 30051, Ben Bella Road, Lusaka, Tel: 260 211 229725/32, Fax: 260211225107, Email: mbyanyima@comesa.intBrian Nsofu, Assistant Coordinator,SPS, P 0 Box 30051, Ben Bella Road, Lusaka, Tel: 260 211 229725/32, Fax: 260211225107, Email: bnsofu@comesa.mtBeatrice Mututuru, Translator, P 0 Box 30051, Ben Bella Road, Lusaka, Tel: 260 211 229725/32, Fax: 260211225107, Email: bmututuru@comesa.int

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Harriet Nambule Ma!indi, Administrative Assistant, P 0 Box 30051, Ben Bella Road, Lusaka, Tel: 260977800638/260211 229725/32, Fax: 260211225107, Email: hnambuIe@comesa.intChristine Chibamba, Accountant, P0 Box 30051, Ben Bella Road, Lusaka, Tel: 260 211 229725/32, Fax: 260211225107, Email: cchibamba@comesa.int