Aflasafe™ pea amendment for usaid/East Africa February 2015



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Bio-control Research and Development


To date, efforts surrounding the introduction, manufacture, and use of aflasafe in Tanzania have developed to the point of identification and isolation of selected atoxigenic A. flavus strains as potential components of future aflasafe appropriate for use in Tanzania. As Dr. Fenton Beed, Plant Pathologist at IITA-East Africa, has noted, country-level efforts are utilized in part to support production of aflasafe products appropriate for regional application. In effect, this means that aflasafe comprised of atoxigenic strains found to be endemic in all, or parts, of Kenya and Tanzania (for example) would be appropriate for use in those areas.64

As noted above the identification and isolation of endemic atoxigenic strains of A. flavus should support the production of aflasafe appropriate for use within Tanzania. However, key stakeholders expressed an explicit desire for Tanzanians to have greater involvement in the process of research and development.65 The national partners were involved in sampling of crops and trainings were also provided for sample collection for bio-control. Bio-control training was received by the two Tanzanian scientists – Happy Doudi, from the MAFSC66 – had received training in aflasafe production under the guidance of IITA, in Ibadan, Nigeria. A second Tanzanian (Emmanuel Koyano) was trained for three months in Peter Cotty’s laboratory in University of Arizona. The strain identification was done in Nigeria and the US since Tanzania did not have the research facilities. IITA Tanzania has since established a laboratory that will be involved in field research and laboratory analysis.

Tanzanian stakeholders indicated that they want to see further increased efforts in building capacity and providing training to support local ownership in development and sustainable implementation of the bio-control This sentiment underscores gaps in the bio-control implementation approach to-date, local awareness at present, and the current capacity of primary Tanzania institutions and scientists.

According to the IITA, the third phase of field testing will now move to Tanzania with an expectation that a lot more Tanzanians will be involved in this work, thus addressing some of the stakeholders’ concerns.

In addition to requests for greater Tanzanian ownership in the process, key stakeholders expressed reservation that the technologist, IITA, was leading the product promotion effort; stakeholders advocated for a more balanced approach to introduction of the product.67 Other stakeholders expressed concern regarding the potential for imposter products hitting the market, an issue that underscores the importance of developing viable certification and labeling processes. With strains identified and isolated, and hotspots of aflatoxins in Tanzania known, it will be incumbent on project proponents to bolster technical capacity and increase local sense of process-ownership as project implementation approaches product manufacture.

Awareness Raising and Demand Creation


The Country Assessment for Aflatoxin Contamination and Control in Tanzania provides pertinent information about several efforts being undertaken to establish prevalence of aflatoxins in maize, groundnuts and cassava in Tanzania.68

Efforts by the EAC, COMESA, PACA and institutions such as IITA have made headway in increasing awareness about aflatoxins, though much work needs to be done particularly at the smallholder farmer level. IITA’s Africa Rising program, following up on 2012 surveys to assess the hotspots of aflatoxins in Tanzania (i.e. the areas with the highest saturation of aflatoxins), is making inroads through the promotion of improved post-harvest handling techniques specifically targeting aflatoxin-reduction. Interestingly, early survey results from these efforts, which are being conducted in Babati, one of the previously identified hotspots demonstrates an extremely low preponderance of aflatoxins among sampled crops, even prior to introduction of improved post-harvest handling techniques. It should be noted that toxin level varies from year to year, place to place, and within field sample. Thus it is not unusual that an area with high toxin would show low levels in another year and vice-versa.

Notwithstanding, as outlined in the core aflasafe PEA, the market demand for the product remains a question. Proponents of aflasafe suggested that a public sector/public health good model would be the most effective vehicle for dissemination of the product and most appropriate given the public health risks posed by uncontrolled exposure to aflatoxins.

Registration of aflasafe


Tanzania has a reputable bio-pesticide registration process and a number of bio-pesticides have been registered for use in Tanzania. Approval of bio-pesticides requires TPRI review of completed dossiers and subsequent approval by the Approval Committee of the evaluation report prepared by the TPRI research scientist conducting dossier review. The Approval Committee is comprised of stakeholders from TPRI, University of Dar es Salaam, the Sokoine University of Agriculture (SUA), TBS, TFDA, GCLA, NEMC, MLDF, MoA, and MoA-Zanzibar. BCAS, an advisory committee to NPPAC, is responsible for approval of technical test results for registration of any biological agent and importation.69 In discussions related to future registration of aflasafe, some of these stakeholders, such as representatives of TFDA and NEMC, expressed concerns about potential human health and environmental risks that could potentially arise through manufacture and use of the product. To facilitate registration of the product in Tanzania, there may be a need for better communications regarding benefits and risks with institutions responsible for ensuring human and environmental health and safety.

Establishment of Manufacturing


As with product registration, selection and screening of sites for manufacturing facilities has yet to occur in Tanzania. When prospective sites are identified, their establishment will be subject to NEMC’s environmental permitting processes which include receipt of permission from the Division of Environment within the Vice President’s Office, as well as registration within Tanzania via preparation of an Environmental Impact Assessment for the proposed facility. The EIA process includes a requirement to complete NEMC’s registration form70 and conduct of the EIA by a registered Tanzanian EIA practitioner.


Manufacturing Processes and Production of aflasafe


Presently, Tanzania is not yet ready to effectively regulate the manufacture and use of aflasafe and is relying heavily on IITA for building its technical capacity and support. Currently IITA places emphasis is on strain identification and testing and have not yet began to focus on manufacturing. Manufacturing training will be addressed subsequently. Capacity will be first developed in IITA-Tanzania where Tanzanian nationals will receive training.

Training and capacity building will be needed to establish adequate QA/QC mechanisms. Without autonomous regulatory capacity to provide independent review and evaluation of the quality and effectiveness of aflasafe, Tanzania’s limitations regarding aflasafe commercialization will persist.


Post-Production Storage and Distribution


The Ministry of Agriculture extension services, as well as agro-service centers, are the most likely channels to utilize for storage and distribution of finished product. Some stakeholders raised concern about the possibility of fraudulent products being disseminated under the guise of aflasafe; as Tanzania currently does not have the capacity for certification or “branding” of aflasafe-treated products, this risk will have to be monitored with occasional visits to service centers known to supply aflasafe.

Use of aflasafe


Stakeholders in Tanzania expressed little concern regarding future use of aflasafe. The limitations faced, if any, will be heavily linked to the success of awareness-raising and demand creation efforts. Agriculture extension agents, currently actively utilized in the promotion of improved post-harvest handling techniques on the Africa RISING project, will likewise be a necessary vehicle for training and capacity building efforts in proper use.

Food Safety Surveillance


Despite the limitations in technical capacity regarding the evaluation of aflatoxins discussed earlier, efforts within USAID/Tanzania’s Africa RISING program to measure levels of aflatoxins, and track their response to improved post-harvest handling practices, such as elevated drying and use of improved granaries or triple-lined bags for storage, comprise the in-country sampling and monitoring capacity.71 While the Africa RISING program represents an initial sampling effort, additional sampling and quality monitoring are necessary aspects of the long-term monitoring requirements established in the core PEA document.
  1. Burundi


Burundi is a small-landlocked country in the African Great Lakes Region, bordered by Rwanda, Tanzania, and the Democratic Republic of Congo (DRC) as well as Lake Tanganyika, an important local, regional, and international resource. With one of the densest populations in Africa72, Burundi has the fourth-lowest per-capita gross domestic product in the world73 and subsistence agriculture serves as the primary source of livelihood for approximately 90 percent of the population. Limited infrastructure, including fewer than 140 km2 of irrigated land, manifests in predominantly rain-fed agricultural production.

The country, fewer than ten years removed from a destructive civil war, has experienced modest economic growth in recent years, though still faces significant economic and political challenges. Agriculture comprises about 40 percent of Burundi’s GDP (down from approximately 70 percent in the 1970s), with the service sector and industry accounting for the remainder.74

Notwithstanding, agriculture remains an economic activity of fundamental importance, with most farmers primarily growing staple crops such as cassava, bananas, maize, beans, rice, sorghum, and groundnuts.75 Maize comprises nearly five percent of total consumption, and accounts for nearly 10 percent of the total harvested area in Burundi. Maize’s status as a staple crop in Burundi, in particular, underscores the value of introducing a bio-pesticide such as aflasafe, particularly given the suitability of Burundi’s environment for the growth of A. flavus and the propensity for growth of toxigenic strains of A. flavus on maize to lead to production of unsafe levels of aflatoxins on maize in many areas globally.

Baseline Environmental Conditions


Geography & Climate. Burundi has a hilly terrain, as well as extensive marshlands, and a tropical humid climate. Average annual rainfall varies throughout the country, ranging from 2,000 mm at higher altitudes to 1,000 mm in the depressions (see Table 2 below). The country is comprised of five agro-ecological zones76: the western plains of Imbo, the steep region of Mumirwa, the Congo–Nile Divide, the Central Highlands, and the depressions of Kumoso to the east and Bugesera basin to the northeast. Burundi has two longer, and one shorter, rainy season; one that extends from February to May, one from September to November, and a two-week rainy period in January. The dry season is typically from June through September.

Topography. Burundi is made up of mainly mountains and plateaus, with a western mountain range running north-south and continuing into Rwanda. Mt. Heha is the highest point in the country, at 2,670 m. The rest of the country is above 914 m, besides a narrow plain alongside the Ruzizi River. From the mountains eastward, the land gradually declines to about 1,400 m near the southeastern and southern border. The central plateau has an average elevation between 1,500 and 2,000 m. The major rivers of Burundi form natural borders for most of the country, such as the Kanyaru and Kagera Rivers along the Rwandan border. Most of the southern border is formed by the Malagarasi River. Burundi’s major lakes are the Tanganyika, the Cohoha, and the Rweru.77




Map 3: Topographic Map of Burundi
Environmental Degradation. Burundi’s high population density, and growing population, continues to put strain on natural resources. The country’s natural forest ecosystem is gradually disappearing, with land often converted from forest for agricultural use, and in turn biodiversity has suffered. Large mammals especially, including gorillas and elephants, are being displaced. USAID’s 2011 Environmental Threats and Opportunities Assessment (ETOA) for Burundi characterizes the environment as follows:



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