Aflasafe™ pea amendment for usaid/East Africa February 2015



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Table of Contents


I.Introduction 9

II.Kenya 14

Baseline Environmental Conditions 15

Institutional Framework 18

Pesticide/Pest Product Registration Process 24

Legal Framework and Relevant Laws 27

Gap Analysis 27

Bio-control Research and Development 27

Awareness Raising and Demand Creation 28

Registration of aflasafe 29

Establishment of Manufacturing 29

Manufacturing Processes and Production of aflasafe 30

Post-Production Storage and Distribution 30

Use of aflasafe 31

Food Safety Surveillance 31

III.Tanzania 32

Baseline Environmental Conditions 32

Institutional Framework 37

Gap Analysis 42

Bio-control Research and Development 42

Awareness Raising and Demand Creation 44

Registration of aflasafe 44

Establishment of Manufacturing 45

Manufacturing Processes and Production of aflasafe 46

Post-Production Storage and Distribution 46

Use of aflasafe 46

Food Safety Surveillance 46

IV.Burundi 48

Baseline Environmental Conditions 48

Institutional Framework 52

Pesticide/Pest Product Registration Process 55

Legal Framework and Relevant Laws 56

Gap Analysis 57

Bio-control Research and Development 57

Awareness Raising and Demand Creation 57

Registration of aflasafe 58

Establishment of Manufacturing 59

Manufacturing Processes and Production of aflasafe 59

Post-Production Storage and Distribution 59

Use of aflasafe 60

Food Safety Surveillance 60

V.Uganda 62

Baseline Environmental Conditions 62

Institutional Framework 69

Gap Analysis 75

Bio-control Research and Development 75

Awareness Raising and Demand Creation 77

Registration of aflasafe 77

Establishment of Manufacturing 77

Manufacturing Processes and Production of aflasafe 78

Post-Production Storage and Distribution 78

Use of aflasafe 78

Food Safety Surveillance 79

Attachment A – List of Preparers 80

attachment b – stakeholders consulted 83


Acronyms

ASDP Agricultural Sector Development Programme (Tanzania)

AAS Atomic Absorption Spectrometer

APPEAR Aflatoxin Policy and Program for the East Africa Region

BBN Bureau Burundais de Normalisation et Contrôle de la Qualité

BCAS Biological Control Agents Subcommittee (Tanzania)

BEO Bureau Environmental Officer

CAADP Comprehensive Africa Agriculture Development Programme

CCRD Chemical Control and Registration Board (Uganda)

CFT Confined Laboratory Trial

CITES Convention on International Trade in Endangered Species of Wild Fauna and Flora

CNTA National Center of Food Technology (Burundi)

COMESA Common Market for Eastern and Southern Africa

COSTECH Commission for Science and Technology (Tanzania)

km3/year Cubic kilometers per year

m3/year Cubic meters per year

DGE General Directorate of Livestock (Burundi)

DGMAVA General Directorate of Agriculture (Burundi)

DoE Directorate of Environment (Tanzania)

DRC Democratic Republic of Congo

DRD Division of Research and Development (Tanzania)

DRTE Department of Research, Training, and Extension (Tanzania)

EAC East African Community

EACG East Africa Grain Council

EEA Enabling Environment for Agriculture

EIA Environmental Impact Assessment

EMMF Environmental Mitigation and Monitoring Framework

ETOA Environmental Threats and Opportunities Assessment

GAP Good Agricultural Practices

GC Gas Chromatography

GCLA Government Chemist Laboratory Agency (Tanzania)

GDP Gross Domestic product

GHP Good Hygienic Practices

GoK Government of Kenya

GSP Good Storage Practices

ha hectares

HPLC High Performance Liquid Chromatography

IFDA International Fertilizer Development Center

IFPRI International Food Policy Research Institute

IITA International Institute of Tropical Agriculture

ILRI International Livestock Research Institute

INECN National Institute for the Conservation of Nature (Burundi)

INSP National Institute of Public Health (INSP)

ISABU Institut des Sciences Agronomiques du Burundi

KALRO Kenya Agricultural and Livestock Research Organization

KARI Kenya Agricultural Research Institute

KEMRI Kenya Medical Research Institute

KEPHIS Kenya Plant Health Inspectorate Service

km kilometers

KSTCIE Kenya Standing Technical Committee on Import and Export

MAAIF Ministry of Agriculture, Animal Industry and Fisheries (Uganda)

MAFC Ministry of Agriculture, Food Security and Cooperatives (Tanzania)

MEEATU Ministry of Water, Environment, Land Management and Urban Planning (Burundi)

MEO Mission Environmental Officer

MINAGRI Ministry of Agriculture and Livestock (Burundi)

MITM Ministry of Industries, Trade and Marketing (Tanzania)

MLDF Ministry of Livestock Development and Fisheries (Tanzania)

mm millimeters

MoA Ministry of Agriculture (Kenya)

MoE Ministry of Environment (Tanzania)

MoH Ministry of Health (Kenya, Uganda)

MoWI Ministry of Water and Irrigation (Tanzania)

MPH Ministry of Public Health (Burundi)

MS Mass Spectrometry

MTTI Ministry of Tourism Trade and Industry (Uganda)

MWE Ministry of Water and Environment (Uganda)

NAADS National Agricultural Advisory Services Organization (Uganda)

NaCRRI National Crops Resources Research Institute (Uganda)

NAIP National Agricultural Investment Plan (Burundi)

NARI Public Agricultural Research Institute (Uganda)

NARL National Agricultural Research Laboratories (Uganda)

NARO National Agricultural Research Organization (Uganda)

NARS National Agricultural Research System (Tanzania)

NEAC National Environmental Advisory Committee (Tanzania)

NEMA National Environment Management Authority (Kenya, Uganda)

NEMC National Environmental Management Council (Tanzania)

NGO Non-Governmental Organization

NPPAC National Plant Protection Advisory Committee (Tanzania)

OSH Occupational Safety and Health

PACA Partnership for Aflatoxin Control in Africa

PARTS Pesticide Approval and Registration Technical Sub-committee (Tanzania)

PCPB Pest Control Products Board (Kenya)

PEA Programmatic Environmental Assessment

PICs Prior Informed Consent

PMO-RALG Prime Minister’s Office, Regional Administration and Local Government (Tanzania)

POPs Persistent Organic Pollutants

QA/QC Quality Assurance/Quality Control

REA Regional Environmental Advisor

REC Regional Economic Communities

RISING (Africa) Research in Sustainably Intensification for the Next Generation

SFPA Strategic Framework for Poverty Alleviation (Burundi)

km2 Square kilometers

SUA Sokoine University of Agriculture (Tanzania)

S&T Science and Technology

TAFIRI Tanzania Fisheries Research Institute

TAFORI Tanzania Forestry Research Institute

TBS Tanzania Bureau of Standards

TFDA Tanzania Food and Drugs Authority

TPRI Tropical Pesticide Research Institute (Tanzania)

UDSM University of Dar es Salaam

UNADA Uganda National Agro-Input Dealers Association

UNBS Uganda National Bureau of Standards

UNCST Uganda National Council for Science and Technology

UNESCO United Nations Educational, Scientific and Cultural Organization

USAID United States Agency for International Development

USCIA United States Central Intelligence Agency

USG United States Government

USTA Uganda Seed Trade Association

ZARDI Zonal Agricultural Research and Development Institute (Uganda)

  1. Introduction


This document is an Amendment to the Programmatic Environmental Assessment (PEA) for the Manufacture and Use of aflasafe™ in sub-Saharan Africa (also referred to as the “core” aflasafe PEA).1 This Amendment focuses on the potential manufacture and use of aflasafe in four countries of the East African Community (EAC): Kenya, Tanzania, Burundi and Uganda. These countries fall within the programming mandate of the USAID/East Africa Regional Mission in Nairobi, which is charged with coordinating and integrating economic growth (and other development objectives) across the East Africa sub-region. USAID/East Africa is currently supporting efforts to improve food security and public health through the control of aflatoxins, the prevalence and impact of which are well documented in the core aflasafe PEA. There are currently a number of mechanisms in place through which USAID can implement aflatoxin-related programming in the East Africa sub-region, including the Aflatoxin Policy and Program for the East Africa Region (APPEAR) project. Among other interventions, the APPEAR project encompasses the development, manufacture and use of a bio-control product for aflatoxins, called aflasafe. Based on the principle of competitive displacement, aflasafe uses non-toxic, or atoxigenic strains of the fungus Aspergillus flavus (A. flavus) to out-compete the more prevalent, toxigenic strains of A. flavus that produce aflatoxins. Crops treated with aflasafe, which is generally regarded as a bio-pesticide, are protected from harmful contamination by aflatoxins. Treated crops are consequently safer to eat and may command a premium among potential buyers.

Interest in aflasafe spans much of the African continent. The product is commercially available in Nigeria, and efforts at product registration are underway in Senegal. Zambia, Mozambique, Ghana and Tanzania are also interested in developing aflasafe variants2 appropriate for use in their respective countries and/or regions. USAID may or may not support aflasafe manufacture or use in countries outside East Africa, either in the short or long term. The Agency is at minimum interested in bio-control as one element of a broader effort to reduce the prevalence and impact of aflatoxins across Africa. The manufacture and use of aflasafe is therefore assessed in the core PEA from the standpoint of possible implementation across all of sub-Saharan Africa. However there remain a number of considerations that warrant examination at the country or regional level. These considerations are noted in the core PEA, and are vital to informing an accurate assessment of the potential adverse environmental impacts of aflasafe manufacture or use in a specific geo-political or eco-regional context.

This Amendment provides the requisite assessment of the following factors as they relate to the environmental risk of aflasafe manufacture and use in each of Kenya, Tanzania, Burundi and Uganda:


  • Baseline environmental conditions;

  • Host-country institutions and policy and legal context; assessment of product registration criteria and process for bio-pesticides;

  • Differences from the core PEA’s assessment of significant issues of concerns based on the consideration of factors at the individual country or regional level; and

  • Differences in implementation of the Environmental Mitigation and Monitoring Framework (EMMF) required by the core PEA based on the consideration of factors at the individual country or regional level.

These factors are evaluated in unique, country-specific analyses in the subsequent sections of this Amendment. The identification of any differences in the assessment of potential impacts once they are viewed through a local or regional lens is effectively a “gap analysis”—the purpose of this Amendment is to assess the potential manufacture and use of aflasafe in East Africa only as it differs from the conclusions drawn and requirements established in the core PEA. The country-level information provided in this Amendment will complement the broader, regional characterizations provided in the core PEA. The findings and requirements of the core PEA, however, will be applicable to relevant aflasafe efforts in Kenya, Tanzania, Burundi, or Uganda (or in other countries in the purview of USAID/East Africa) unless otherwise specifically stated in this Amendment.

Together, the core PEA and this gap analysis-oriented PEA Amendment for East Africa will provide the regional and bilateral missions a roadmap for the environmentally sound design and management of aflasafe activities. The PEA and PEA Amendment also fulfill the criteria of the Agency’s Environmental Procedures under 22 CFR 216 (“Reg. 216”), which requires assessment of proposed actions with the potential for significant environmental impacts. While these documents are intended to meet most, if not all, of the technical burden associated with the assessment of potential environmental impacts, additional criteria may exist at the country level that affect environmental compliance. For example, USAID best practice requires that pesticides (including bio-pesticides) be registered or approved for use in the host country prior to USAID supporting the use of that product in the host country. In this case it means that, despite preparation of the aflasafe PEA documents, USAID cannot support the manufacture or use of aflasafe in a country that has not otherwise evaluated (and not disapproved) its use. In addition to the importance of host-country product registration status, other prerequisites may include impact assessment criteria that are imposed independent of the United States government (USG) requirement for preparation of this PEA. In those instances, the PEA’s material analysis can be adapted—and expanded or reduced, as needed—into a form that is acceptable to the cognizant host country institution. Review and consideration of the aflasafe PEA by USAID Operating Units should involve the Mission Environmental Officer (MEO), Regional Environmental Advisor (REA), and/or Bureau Environmental Officer (BEO) to clarify the various environmental compliance requirements that may exist beyond those established in Reg. 216. These individuals can help the Operating Unit understand and navigate any additional environmental compliance actions, as well as contribute to the environmentally sound design and management of aflasafe-related programs. The MEO and REA in particular can assist with implementation of the PEA’s mitigation and monitoring requirements, which are included in the core PEA’s Environmental Mitigation and Monitoring Framework (EMMF) and subsequent country-level gap analyses.

USAID-backed aflasafe programming in East Africa is likely to benefit from the involvement of regional bodies like the EAC and the Common Market for Eastern and Southern Africa (COMESA). Initiatives such as the effort to secure aflasafe product registration at a regional scale—a scenario in which individual country requirements might be waived or deferred in the interest of broader, more rapid commercialization—would greatly facilitate the manufacture and use of aflasafe in target countries. The role of Regional Economic Communities (RECs) like the EAC or COMESA reflect common socio-economic interests and shared identity within sub-Saharan Africa and these entities have already begun efforts to introduce regional product registration and harmonized sampling protocols based upon shared environmental considerations, similarities in food security, economic development, and agricultural production.

The EAC in particular is leading a number of efforts to combat aflatoxins and promote awareness and information-sharing among member states. While such efforts do not focus specifically on bio-control (i.e., the use of aflasafe), they do underscore the need for a balanced approach to addressing the public health and food security challenges posed by aflatoxins. Formation by the EAC of the Regional Experts Working Group on Aflatoxins (REWGA) is evidence of the range of skills and expertise that are needed to “work at a regional level to provide leadership for coordinating and monitoring strategic interventions on aflatoxin control.”3 This type of collaboration spans sectors with the goal of “supporting the agricultural development, safeguard consumer health and facilitate trade by catalyzing , coordinating and promoting effective aflatoxin control along all agricultural value chains in East Africa.”4 The EAC is also instrumental in developing and implementing a regional roadmap for combating aflatoxins in East Africa. The EAC Aflatoxin Steering Committee was central to an October 2014 strategy and planning meeting in Kigali, Rwanda that also included USAID, CDC, and a number of private-sector stakeholders, among others.

Beyond the policy realm, similarities in the obstacles to food security and economic development, and the nature of agricultural production mean that aspects of effective environmental management of aflasafe manufacture and use in one country of East Africa are likely to reflect that of its neighbors. This is underscored, in part, by the shared agro-ecological zones that comprise the four countries included in this PEA Amendment. As indicated in Table 1, Kenya, Tanzania, Burundi and Uganda share numerous agro-ecological zones, meaning that the baseline environmental conditions for aflasafe manufacture and use will in many instances be similar across countries.

While common factors will generally support the regional manufacture and use of aflasafe, at least in terms of environmental considerations, USAID missions will still need to understand and account for discrete differences at the county level. This PEA Amendment will assist with this process, at the same time meeting core USAID requirements for the assessment of proposed actions.



Table 1: Terrestrial Ecoregions of Burundi, Kenya, Tanzania and Uganda5

Terrestrial Ecoregion

Burundi

Kenya

Tanzania

Uganda

Tropical and Subtropical Moist Broadleaf Forests

Afrotropical Albertine Rift Montane Forests










Afrotropical East African Coastal Forests











Afrotropical Eastern Arc Montane Forests











Tropical and Subtropical Grasslands, Savannas and Shrublands

Afrotropical Horn of Africa Acacia Savannas












Afrotropical East African Acacia Savannas










Afrotropical Central and Eastern Miombo Woodlands











Afrotropical Sudanian Savannas











Temperate Grasslands, Savannas and Shrublands

Afrotropical Sudd-Sahelian Flooded Grasslands and Savannas












Afrotropical Zambezian Flooded Savannas












Montane Grasslands and Shrublands

Afrotropical Southern Rift Montane Woodlands












Afrotropical East African Moorlands










Mangroves

Afrotropical East African Mangroves











Large Lakes

Afrotropical Rift Valley Lakes









Tropical Coral

Western Indo-Pacific East African Marine














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