Aflasafe™ pea amendment for usaid/East Africa February 2015



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Source: Ezilon.com
Topography. Mount Kenya, located in the Kenyan Highlands, is the highest point in the country, and the second highest point in Africa at 5,199 m. Mount Kenya National Park is also listed as a UNESCO World Heritage Site. Low plains are prevalent in the East along the Indian Ocean, rising to highlands in the center of the country which are divided by the Great Rift Valley, a 6,000 km trench running from northern Syria to central Mozambique. A fertile plateau lies in the west of the country.

Climate. Due to its location along the Rift Valley and various other landforms, Kenya’s variable climate brings frequent droughts and floods, and uneven rainfall. The climate in Kenya ranges from tropical along the coast to dry in the interior. Average annual rainfall is about 630 millimeters (mm) , ranging from less than 200 mm in northern Kenya, to 1,800 mm on Mt. Kenya.13 Heavy rains occur from March to June and short rains from October to November. Climate change will have significant impacts in Kenya. It is already responsible for the retreat of all 11 of Mt. Kenya‘s glaciers, and resulting decline in water levels in the Athi and Tana Rivers. Natural weather disasters have also increased, requiring farmers in high and low rainfall areas to adapt accordingly.14

Soil. Soil type in Kenya varies greatly due to topography and variable rainfall. Soils in Western Kenya are mainly acrisols, cambisols, and their mixtures, and contain iron and aluminum oxides. Young nitosol and andosol soils of volcanic origin are located in the central highlands while coastal soils are generally coarse and low in organic matter and include arenosols, luvisols, and acrisols. Soils in arid and semi-arid areas include vertisols, gleysols, and phaeozems, and contain pockets of sodicity and salinity. Soils in these areas are characterized by low fertility and vulnerability to erosion. Soil salinity is widespread along the Lake Baringo basin in the Rift Valley and in the Tavetta division in the coastal provinces.15

Ecological zones. Kenya has diverse ecological zones and habitats, including lowlands and mountain forests, wooded and open grasslands, semi-arid scrubland, dry woodlands, inland aquatic, and coastal and marine ecosystems. Wetlands are an important factor in Kenya’s economy, affecting agriculture, livestock production, hydroelectric power, fisheries and tourism. The marine waters and mangrove areas along the coast are rich in biodiversity and support a small fishery, although freshwater Lake Victoria produces 90 percent of Kenya’s total catch. Forests provide significant ecosystem services, supporting not only agriculture and tourism, but also watershed functions. Kenyan forests are also home to some of the highest levels of biodiversity in the country.16

Water resources. Kenya is characterized as a water scarce country, where demand exceeds renewable freshwater sources. Total renewable water resources totaled 30.7 billion cubic meters per year (m3/year) in 2008.17 Of this total, 30.2 billion m3/year is surface water, and 3.5 billion m3/year is groundwater (most of this is overlap with surface water, from groundwater drainage into rivers or river seepage into aquifers). Kenya has nine lakes; most are saline, with the exception of Victoria, Naivasha, and Baringo Lakes. Nakura and Naivasha are designated as Ramsar sites as wetlands of international importance for the conservation of biodiversity. Kenya has five main drainage basins: Lake Victoria, the Rift Valley and inland lakes, Athi River and coast, Tana River, and Ewaso Ng’iro River, which is the largest, covering 36.3 percent of the country.18 Hydropower supplies around 61 percent of Kenya’s electricity demand at 677.3MW, whereas hydroelectric potential totals 6,000MW. The largest hydropower station is Gitaru with a generation capacity of 225 MW.19

Irrigation. Agriculture is the largest source of water withdrawal, accounting for 79.2 percent of total water use in the country. Irrigation potential in Kenya is estimated at 353,060 ha, with over 50 percent from the Nile basin (Lake Victoria).20 While 16 percent of the land has medium to high potential for irrigation, less than 10 percent of irrigation potential is utilized and only two percent of total arable land is actually irrigated. Smallholder and commercial/private schemes dominate irrigation development; 75 percent of Kenya’s agricultural output is produced by small-scale farms. A major obstacle to the expansion of irrigation is the rising cost of modern irrigation projects. A lack of investment has caused the amount of irrigated land in Kenya to stagnate. Consequently, Kenyans depend heavily on rainfed agriculture.21 The main irrigated crops are rice, maize, sugarcane, vegetables, bananas, citrus, coffee, tea, cotton and flowers.22

Institutional Framework


Kenya has a robust and well-articulated institutional framework for the development, manufacture and use of bio-pesticides, including aflasafe. A variety of state entities are involved at various stages in researching, promoting and regulating pest control products that are perceived as beneficial to public health and/or agricultural production and food safety. The private sector in Kenya is also vested in the potential benefits of aflasafe manufacture and use, and is poised to make material contributions to the commercialization process. Agricultural interests such as the Eastern Africa Grain Council (EAGC) and Kenya Cereal Millers Association are keenly aware of the impact of aflatoxins on their industry and are actively participating in national and regional efforts to design and implement meaningful programs to combat aflatoxins, including the use of bio-control technology. The EAGC was represented at a regional workshop on control of aflatoxins in Lilongwe, Malawi in March 2014 sponsored in part by USAID and the Partnership for Aflatoxin Control in Africa (PACA), the region’s leading coordinating body.

The precise role and extent of private-sector involvement in the commercialization of aflasafe in Kenya will primarily be a function of market forces. For example, the level of interest in aflasafe use by grain millers and processors will be based on the value-added the product confers on their commodity, notwithstanding the demonstrated nutritional and public health benefits. The commercial value proposition of aflasafe applies at various points in the crop value chain. However, the role of market forces in the manufacture and use of aflasafe in Kenya is difficult to quantify, and remains an area of dialogue and coordination among its proponents. The inter-relationship between commercial viability (i.e., economic sustainability) and potential adverse environmental impacts of aflasafe manufacture and use is examined in the core PEA. Regardless of the commercialization models that may be employed to realize its adoption and use in Kenya, the Government of Kenya (GoK) will be involved throughout the aflasafe product lifecycle.



The following GoK institutions have a specific role in the development, manufacture and use of aflasafe in Kenya; the mandate and overall orientation of each is summarized below. It is important to note that government entities are facing a number of changes designed to create newly accountable and transparent institutions. These changes are consistent with the 2010 Constitution of Kenya, which seeks to improve stability through the protection of rights, decentralization of executive power, and new county governments for equitable service delivery (among other means). Decentralization and the effort to create new government services reflect a broader goal of devolution, which will likely impact the state-run bodies charged with administering various aspects of aflasafe manufacture and use in Kenya. The recent formation of KALRO, which encompassed the Kenya Agricultural Research Institute (KARI), its primary predecessor, is a good example of the types of institutional changes that are taking place, some of which will have direct bearing on the commercialization of aflasafe in Kenya.

Ministry of Agriculture (MoA)—The MoA is the primary line ministry responsible for agricultural production and food security in Kenya. It also has a natural resource management mandate to “enhance sustainable use of land resources as a basis for agricultural enterprises.”23 Many MoA objectives are met through the provision of extension services, which enable the ministry to engage with all types of farmers nationwide. MoA extension services are often the only form of technical assistance that smallholder farmers receive on a regular basis. While donor-funded agricultural development programs frequently target rural, smallholder farmers, these efforts are often linked to—or designed to complement—existing Ministry extension capabilities and resources. Extension staff are frequently seen as the ‘go-to’ resource for technical guidance on crop selection and cultivation practices, including the use of agro-inputs. In this regard MoA is instrumental in promoting aflasafe use, particularly in those areas most impacted by aflatoxins—this is also consistent with the MoA mandate to ensure the availability of safe foods. Beyond demand creation for aflasafe (which is essential to the product’s commercial success), MoA is often “closest to the problem,” with direct links to farmers, smallholder or otherwise, that may be producing contaminated food. Consultations with a senior MoA official in early June 2014 indicate an earnest desire to acquire and deploy aflasafe in response to a reported outbreak of aflatoxins in rural areas of the Eastern Province.24 The MoA is the parent Ministry for PCPB, KEPHIS, KALRO and NIB (see below).

Pest Control Products Board (PCPB)—PCPB is the cognizant national authority for the registration of pest control products in Kenya, including pesticides and bio-pesticides. The PCPB was established under the Pest Control Products Act of 1982, and the commercialization of aflasafe in Kenya depends on successful registration of the product by the Board. The charter of the PCPB is to “provide an efficient and effective regulatory service for importation, exportation, manufacture, distribution, transportation, sale, disposal and safe use of pest control products and mitigate potential harmful effects to the environment.”25 Consistent with this objective, PCPB recently granted temporary registration status to aflasafe, allowing commercialization in Kenya to proceed pending the resolution of certain questions on the product’s toxicological and eco-toxicological effects. Consultations with PCPB in early June 2014 indicate that temporary registration status is rare, but is in response to the seriousness of the current threat presented by contamination by aflatoxins. As part of the registration process, PCPB also prescribes pesticide labeling requirements and licenses and supervises manufacturing facilities.26

Kenya Plant Health Inspectorate Service (KEPHIS)—KEPHIS is the government agency responsible for ensuring the provision of high-quality agricultural inputs and promoting economic development through the cultivation and export of competitive crops and products. The primary regulatory role of KEPHIS in aflasafe commercialization is to ensure that sanitary and phyto-sanitary (SPS) requirements are met in development and use of the bio-control product. This includes evaluation of the atoxigenic strains of A. flavus that constitute aflasafe, which was completed through expert consultation—as the secretariat of the Kenya Standing Technical Committee on Import and Export (KSTCIE; detailed information below), KEPHIS was integral to strain import and export and laboratory analysis. While PCPB is charged with assuring the efficacy of aflasafe, KEPHIS must account for the product’s impact on plant health. Consultations with KEPHIS in early June 2014 indicate that the agency recognizes the potential value of aflasafe, particularly given concerns over increasing amounts of aflatoxins in the local environment. KEPHIS also provides a service in conjunction with the Ministry of Health (MoH) to analyze products like maize and peanuts for contamination by aflatoxins, which may also play a role in any future aflasafe certification effort.27

Kenya Agricultural and Livestock Research Organization (KALRO)—KALRO is the GoK’s primary agricultural research entity, with a mission to “promote, streamline, coordinate and regulate research in crops, livestock, genetic resources and biotechnology in Kenya…”28 KALRO is among the strongest centers of support for aflasafe manufacture and use within the Kenyan government. The KALRO dryland agricultural research facility at Katumani, Machakos District (“KALRO Katumani”) is currently supporting EAC-level initiatives for the control of aflatoxins. This includes recent rehabilitation of the research station’s laboratory to a Biosafety Level 2 (BSL-2) facility capable of processing up to 4,000 samples of aflatoxins per season. KALRO has also facilitated farmer field trials of aflasafe in Kenya, and acknowledges that its concern over aflatoxins is “very high.” KALRO also researches and promotes agricultural BMPs for dryland cultivation (e.g., terracing for water retention, dry planting, composting, crop rotation, etc.) that may ultimately complement bio-control efforts.

In an important development, KALRO Katumani is also expected to host one of the country’s first aflasafe manufacturing facilities—the four counties covered by the research center constitute the “epicenter of aflatoxins,” according to the Centre Director.29 A groundbreaking ceremony for the planned manufacturing facility was held in November 2014, which also marked inauguration of the center’s Regional Mycotoxin Research Laboratory. The high-profile event reinforced KALRO’s leadership in aflasafe-related activities within GoK, garnering media coverage and bringing Cabinet Secretary for Agriculture, Livestock and Fisheries Development, the Hon Felix Koskei, to Katumani for commissioning of the laboratory and to preside over the groundbreaking. KALRO should be viewed by aflasafe proponents as a valuable partner in commercialization of the product in Kenya.



National Irrigation Board (NIB)—NIB is a GoK entity with the broad mission of providing “irrigation and drainage for improved livelihoods, food security and economic growth …”30 However, alignment of NIB under the Ministry of Agriculture in September 2013 underscores the Board’s food security mandate.31 Established in 1966 as a successor to the African Land Development Unit (ALDEV), NIB is responsible for numerous irrigation projects, including the Mwea, Hola, Perkerra, Ahero, West Kano, Bunyala and Bura schemes. Maize cultivated under the Hola and Bura schemes, in particular, is reportedly frequently contaminated with aflatoxins, to the extent that several grain procurement agencies, including the World Food Program, have had difficulty purchasing maize due to its toxicity. In response, NIB is planning to implement aflatoxin control efforts in the Hola and Bura zones, which would include the use of aflasafe. These efforts may encompass the establishment of a local aflasafe manufacturing facility to ensure an adequate supply for NIB activities. It is not known if there is a specific timeline for construction and/or operation of the manufacturing facility, which is one of only two such facilities in Kenya considered in this PEA (the other being the facility underway at KALRO Katumani). Regardless of its exact location and timeframe for construction and operation, the NIB facility will be subject to all applicable GoK regulations, including those normally enforced PCBC, NEMA, and others.
National Environment Management Authority (NEMA)—NEMA is the overarching environmental protection entity in Kenya and operates under the Ministry of Environment, Water and Natural Resources. Their mission is to “enhance the quality of the environment through coordination, research, facilitation and enforcement, while encouraging responsible individual, corporate and collective participation towards sustainable development.”32 In this vein NEMA is responsible for reviewing and approving any environmental impact assessments (EIAs) or similar studies that may be required in conjunction with the manufacture and use of aflasafe, even following product registration by PCPB. The siting and construction of aflasafe manufacturing facilities in particular is anticipated to trigger the NEMA EIA process. Consultations with NEMA in early June 2014 also indicate that either a “project report” (i.e., low-level evaluation) or “project study” (i.e., more detailed evaluation akin to an EIA) may be required for the use of aflasafe at the community level. All evaluations/assessments must be completed by a registered environmental consultant, though NEMA claims to follow a “consultative process.” NEMA does not provide training or capacity or awareness building in pesticide safer use, deferring to the PCPB and MoA for guidance in this process.33 Although an important regulatory entity, NEMA is not positioned on the “front line,” nor is it equipped to advocate or endorse the commercialization of aflasafe in Kenya.

Ministry of Health (MoH)—The MoH is concerned with the manufacture and use of aflasafe from the standpoint of protecting public health, both from the vantage of controlling aflatoxin-related illness, as well as the potential adverse impacts of bio-pesticide use on human health. Consultations with the Ministry’s Department of Public Health in early June 2014 indicate that while aflatoxins are considered a “huge” problem, there is a general skepticism regarding the need for and/or safety of bio-control technology. Improper crop transportation and storage were rather identified as the primary causes of contamination from aflatoxins, which would shift focus away from the use of aflasafe toward improved crop transportation and storage.34 The MoH does not play a direct role in product registration, but as noted above, it may, in collaboration with KEPHIS or other entities, ultimately help differentiate aflasafe-treated crops through some form of testing and certification or branding initiative. The MoH is the parent Ministry for KEMRI (see below).

Kenya Medical Research Institute (KEMRI)—KEMRI is a state-run health research entity established under the Science and Technology (Amendment) Act of 1979.35 KEMRI’s research encompasses the type of public health issues that are associated with the potential risk of aflasafe manufacture and use on immunocompromised sub-populations, such HIV/AIDS and drug-resistant tuberculosis. Consultations with KEMRI in early June 2014 did not indicate significant concern over the potential impact of aflasafe manufacture and use on the health of these groups, assuming appropriate use of the necessary personal protective equipment (PPE) (e.g., gloves, mask/respirator, goggles, etc.) and effective environmental sampling and/or surveillance. The need for control of aflatoxins is recognized within KEMRI, and it was noted that general concerns and risks associated with the handling and (in)appropriate use of synthetic pesticides may outweigh the potential adverse impacts of aflasafe on human health. Overall awareness of aflatoxicosis within the healthcare community is reportedly high, though clinicians could benefit from additional training in identifying and diagnosing the condition.36 While not a critical regulatory body, KEMRI’s research may inform the safer manufacture and use of aflasafe. This type of collaboration could help focus the efforts of aflasafe proponents in highlighting the product’s likely public health benefits and manageable risk profile.


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