Pesticide/Pest Product Registration Process

Pesticide/Pest Product Registration Process

As a member of the KSTCIE, PCPB has been party to these discussions and can use the Committee’s proceedings to inform their decision to register or not register aflasafe for use in Kenya. As of early June 2014, PCPB had recently granted temporary registration status to aflasafe KE01, the variant of aflasafe produced for use in Kenya. The KE01 variant is based on indigenous atoxigenic strains of A. flavus, allowing the product to be characterized, if only for marketing purposes, as “homegrown.” While certainly an important milestone, the temporary registration status appears to stem from the PCPB assertion that the aflasafe registration dossier (i.e., the product’s complete technical application) “had some gaps.”³⁷ The International Institute of Tropical Agriculture (IITA) is the lead aflasafe research and product development entity in Kenya (and APPEAR project Implementing Partner) and was responsible for preparing the aflasafe KE01 product registration report. IITA believes that PCPB seeks clarification on the product’s possible toxicological and eco-toxicological effects. While the precise nature of any questions on the part of PCPB regarding the aflasafe KE01 dossier were not shared in consultations with the PEA team, IITA understands that it will likely be requested to provide additional information.³⁸ Pending further decision by PCPB, temporary registration does permit the registrant, in this instance KALRO, to commercialize the product.³⁹ According to PCPB, temporary registration status extends up to one year, but can then be renewed.

While temporary registration does provide a (potentially open-ended) window for the manufacture and use of aflasafe KE01, product deployment will be constrained by lack of local or regional manufacturing facilities; aflasafe KE01 is produced in Nigeria, currently home to the only industrial aflasafe manufacturing facility in sub-Saharan Africa. Construction is underway in Kenya for a “modular” manufacturing facility that can be easily scaled-up through modular expansion as production needs increase. A groundbreaking ceremony for the modular facility was held at KALRO Katumani in November 2014, though according to IITA, completion of the facility is not expected before November 2015. Until such time that production capacity comes online in Kenya, the expense of aflasafe KE01 imported from Nigeria may substantially limit commercial uptake, regardless of approval from PCPB.⁴⁰

Once manufacturing facilities in Kenya are producing aflasafe, PCPB will remain involved at various stages in the product lifecycle, including regulation of the manufacturing, distribution/sales, and disposal processes through licensure and inspection. PCPB is also supportive of establishing a regional process for aflasafe registration. While the Board “is part of the team working to harmonize registration” within the EAC, it would not comment on a timeframe or the likelihood of success.⁴¹ Until such time that regional protocol and standards for aflasafe might exist, PCPB will continue to adhere to its own product registration criteria.

Legal Framework and Relevant Laws

Currently, aflasafe is under temporary registration status with PCPB. Kenya also has a legal standard for total aflatoxins⁴² of 10 ppb in groundnuts and maize intended for human consumption.

Gap Analysis

Much of the assessment of the potential adverse environmental impacts of aflasafe manufacture and use provided in the core PEA document is based on the experience of the PEA team in East Africa, including Kenya. This field work provided unique access to stakeholders and the physical and institutional environments in which aflasafe will likely be produced and applied. This access was crucial to understanding stakeholder concerns and priorities and the risk factors associated with the issues of concern identified in the PEA Scoping Statement. In this regard the potential adverse impacts and mitigation and monitoring criteria for aflasafe manufacture and use in Kenya reflect, and are generally consistent with those identified in the core aflasafe PEA.

Differences do exist, however. The most notable difference between Kenya and the other EAC countries covered in this Amendment—and almost every other country in sub-Saharan Africa, as encompassed by the core PEA—is that aflasafe is currently registered for use in Kenya. This distinction puts Kenya in the unique position of being able to model the successful, environmentally sound commercialization of aflasafe for its EAC neighbors and across Africa. On the other hand, Kenya may encounter painful “lessons learned” that would likewise benefit other countries considering the use of a bio-control product that targets aflatoxins. Kenya is among only a handful of countries in which aflasafe can either be deployed now, or is expected to be deployed in the near future.

This gap analysis examines Kenya-specific considerations for the manufacture and use of aflasafe through each of the eight lifecycle phases identified and described in the core PEA. This analysis can be used in the context of the PEA’s Environmental Mitigation and Monitoring Framework (EMMF) to develop mitigation and monitoring requirements that respond specifically to conditions and/or circumstances in Kenya. This process is further facilitated through use of template Environmental Mitigation and Monitoring Plans (EMMPs), which are attached to the core PEA. Alignment with the EMMF, and preparation of a country or program-specific EMMP, will enable USAID and its partners to translate this analysis into a targeted and practical set of requirements for the safer, more sustainable manufacture and use of aflasafe in Kenya.

Bio-control Research and Development

With development (and subsequent [temporary] registration) of aflasafe KE01, Kenya has successfully demonstrated the bio-control research and development phase of aflasafe manufacture and use. The identification and isolation of the atoxigenic strains of A. flavus that constitute the active ingredient of KE01 was completed at laboratories in the United States, however. This raises questions regarding the capacity of research laboratories and similar facilities in Kenya and whether such early-stage research and product development could have been undertaken wholly within Kenya. There are also concerns over the (mis)characterization of aflasafe as a genetically modified organism (GMO) technology, which may carry negative connotations. For this reason, future efforts to develop other aflasafe variants for use in Kenya may be undertaken outside of the country. Conversely, aflasafe proponents may insist that future product development be a wholly Kenyan enterprise in order to quell concerns over the use of “foreign” or modified genetic material or the introduction and propagation of alien or invasive strains. The capacity for such product development is increasing in Kenya, with the combined support of GoK, donors, and research entities, along with access to improved equipment and facilities.

Any bio-control research and development activities undertaken in Kenya would need to conform to norms and standards of plant science and genetic research, including the use of BSL-2 laboratory facilities to protect worker and environmental health. Access to such facilities in Kenya should not be problematic, although the availability of the equipment required for strain identification may prove a limiting factor. Kenyan institutions (parastatals, academic, private-sector, NGOs) do possess the technical expertise to continue to research and develop bio-control technologies for aflatoxins.

Awareness Raising and Demand Creation

There is a generally high level of awareness of aflatoxins and their adverse impacts on nutrition, public health, and farm incomes in Kenya. As discussed elsewhere in this PEA, bio-control is but one approach to mitigating aflatoxins, and among the range of control options, arguably the least familiar to the Kenyan public, including smallholder farmers. (Most aflatoxin abatement strategies to date, including those supported by USAID [e.g., AflaSTOP], have emphasized post-harvest handling and storage techniques.)

Beyond increasing aflasafe knowledge and familiarity among target groups, awareness raising efforts will need to address the apparent (mis)perception in certain quarters that aflasafe employs GMO technology. There will also need to be education on the use of aflasafe relative to other approaches to controlling aflatoxins, such and drying and storage—a combination of techniques or approaches may prove optimal. Indicative pricing information would also be important to allow the agro-input supply chain to plan for product distribution and delivery. Farmers and other consumers will also want to account for the likely expense of aflasafe purchase, storage and application. These costs can be compared to the anticipated improvements in yield or crop value, driving initial product demand.

There are numerous channels though which aflasafe can be promoted and through which complementary technical assistance or capacity building can be provided. The MoA and its established (and trusted) extension services could be a valuable partner in promoting the adoption of aflasafe in particular geographic areas, or among particular farmers or farmer groups. Such extension services, whether provided through the MoA or other public or private entities, will be central to awareness raising efforts. This includes the dissemination of targeted, technically sound marketing materials and resolution of any misperceptions regarding the nature of aflasafe and its intended benefits. Demand for aflasafe manufacture and use will depend in large part on the success of these initial awareness raising efforts.

Registration of aflasafe

Registration of aflasafe in Kenya is substantially complete, with aflasafe KE01 granted temporary registration by the PCPB in mid-2014. While full registration may be contingent on receipt of additional technical information from the Registrant (KALRO, with technical support from IITA), PCPB appears responsive to the perceived negative effects of aflatoxins on crops and public health, and was duly satisfied with the registration dossier. Importantly, temporary registration does allow for product commercialization (i.e., manufacture and use). And while temporary registration is typically valid for only one year, this can be renewed, potentially indefinitely.

This milestone sets an important precedent for the potential registration in Kenya of additional aflasafe variants in the future. PCPB is also actively supporting establishment of a regional process for aflasafe registration. Combined, these factors create a supportive environment for aflasafe registration in Kenya.

Establishment of Manufacturing

Kenya remains in the preliminary stages of selecting and/or screening potential sites for aflasafe production. Two sites were suggested in the course of this PEA: one at the KALRO Katumani agricultural research station in Machakos County; and a second proximate to the NIB Hola and Bura irrigation schemes.

These and any other sites proposed for the establishment of aflasafe manufacturing facilities will be subject to NEMA EIA requirements. This may include preparation of either a project report, or project study (or potentially both) based on the location, size and construction of the proposed facility. NEMA claims to take a “consultative” approach to the project EIA process. However, EIA documents must be prepared by a registered environmental consultant. This requirement, as well as the broader EIA process, should be factored into the planning cycle for establishment of aflasafe manufacturing; they will both require time and resources.

It is recommended that aflasafe proponents engage with NEMA as early as possible in the planning cycle in order to clarify specific siting and EIA requirements and process, and to avoid ‘surprises’ once site selection or preparation, or construction has commenced.

Manufacturing Processes and Production of aflasafe

Assuming the establishment of aflasafe manufacturing facilities in Kenya consistent with NEMA requirements, bio-pesticide production will be regulated by PCPB, which includes licensure and inspection of the manufacturing facility. Manufacturing processes must meet requirements for worker health and safety as identified in the core PEA. Production processes and facility operations must also account for potential risks to the health of nearby residents (i.e., those who live near, but are not employed at the facility) and the local environment.

The designers and operators of aflasafe manufacturing facilities in Kenya are likely to have access to the types of supplies, equipment and technologies needed to safeguard workers, residents and the local environment. These include, but are not limited to: PPE (e.g., respirators, gloves, smocks, goggles, boots, etc.); air handling equipment (e.g., vent hoods, exhaust fans, air filters, air conditioners, ductwork, etc.); modern electric or gas-fired mixers, dryers, and other production equipment; plumbing and wastewater infrastructure, including water treatment or containment facilities; and solid waste management, including collection vessels and, if required, an incinerator. The integration and use of this type of equipment will lead to safer aflasafe production processes and appears well within the technical capacity of aflasafe proponents in Kenya.

Post-Production Storage and Distribution

Packaged aflasafe will be stored before and after it enters the agro-input supply chain. Manufacturing facilities will need to provide for some amount of on-site storage to accommodate finished aflasafe as it exits the production process. Agro-input suppliers will also need to store aflasafe for distribution and reselling. Individual farmers and consumers will need to store aflasafe at the farm or household level once it is purchased or received and prior to application. In Kenya aflasafe labeling will be regulated by PCPB, and may include guidance on safer storage.

Distribution of aflasafe is likely to occur through private-sector, public-sector and NGO channels. Actors in these distribution networks will receive instruction on handling and storage in accordance with PCPB and manufacturer guidelines. Kenya has a mature agro-input manufacturing and supply sector and it is expected that aflasafe can be integrated in this distribution network in manner that is consistent with the principles of pesticide safer use.

Use of aflasafe

Stakeholders in Kenya expressed little concern regarding future use of aflasafe. As noted above, the extent of aflasafe deployment and use will depend in large part on the success of awareness raising and demand-creation efforts. Technical training and capacity building, through such channels as the MoA and private-sector extension services, will be a necessary complement to promote the environmentally sounds use of aflasafe and compliance with PCPB and manufacturer guidelines. These extension services are well established and generally trusted by farmers for counsel on crop production and food safety. Proponents should seek to utilize existing extension services once aflasafe enters the Kenyan agro-input supply chain and is made available to farmers and other consumers. Safer use by farmers and other end-users can be greatly enhanced through such outreach and promotion.

Food Safety Surveillance

There is currently no comprehensive approach to food safety surveillance in Kenya that is capable of measuring aflasafe use against increases or gains in crop safety or nutritional value. Proponents of aflasafe are challenged to identify and select a cost-effective and technologically appropriate means of testing for aflatoxins that can also be used to demonstrate the efficacy of aflasafe. Barring the availability of such an approach, the developers, manufacturers and users of aflasafe may find it difficult to “prove” the (presumably positive) effects of aflasafe use on crop quality (and consequently food safety). Ambiguity or uncertainty over the value or impact of aflasafe on food safety, independent of other variables, may undermine widespread product deployment. The dearth of appropriate testing options and lack of a comprehensive surveillance scheme should be factored into commercialization efforts.

3. Tanzania

The agricultural sector plays a crucial role in the economy of Tanzania. Agriculture accounts for more than one-quarter of GDP, provides 85 percent of exports, and employs about 80 percent of the work force.⁴³ Major food crops in Tanzania include maize, paddy (rice), sorghum, wheat, beans, cassava, potatoes and sugar cane. Maize is the dominant crop with a planted area of over 1.5 million ha during recent years, followed by rice with more than 0.5 million ha in recent years.⁴⁴

As Tanzania’s major staple crop, maize is grown by more than 50 percent of Tanzanian farmers, and approximately 85 percent of the population depend upon it for their food or livelihood. Half the maize produced in the country comes from the regions of Iringa, Ruvuma, Mbeya and Rukwa in the Southern Highlands, known as the nation’s “bread basket.”⁴⁵ Much of Tanzania is classified broadly as a “Maize-Mixed” farming system with areas of root crop-based farming in the southern and northwestern areas.

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