REQUEST FOR APPLICATIONS (RFA)

EGAT/AFS-02-001

PROGRAM FOR BIOSAFETY SYSTEMS (PBS)

ISSUE DATE: March 22, 2002

CLOSING DATE: May 31, 2002 (to be received by 5:00 pm EST)

Office of Agriculture and Food Security

Bureau for Economic Growth, Agricultural and Trade

GUIDELINES

FY 2002

PROGRAM FOR BIOSAFETY SYSTEMS (PBS)

TABLE OF CONTENTS

I. PROGRAM SUMMARY AND GOAL

II. BACKGROUND

III. BIOSAFETY SYSTEMS APPROACH

IV. A SPECIAL NOTE ON THE INCORPORATION OF THE BBI PROGRAM

V. PARTNERSHIPS

VI. TARGET COUNTRIES AND REGIONS

VII. A NOTE ON LEADER/ASSOCIATE COOPERATIVE AGREEMENTS

VIII. PROHIBITED ACTIVITIES

IX. PROPOSAL FORMAT

X. SELECTION CRITERIA

XI. SUBMISSION OF APPLICATION

XII. QUESTIONS REGARDING RFA

APPPENDIX A – ABSP EVALUATION REPORT

APPENDIX B – BBI RFA

APPENDIX C - CERTIFICATIONS

Program for Biosafety Systems

I. Program Summary & Goal

A. COLLABORATIVE AGRICULTURAL BIOTECHNOLOGY (CABIO) INITIATIVE

This RFA represents one component of a new USAID initiative that will take a comprehensive and integrative approach to agricultural biotechnology. The Collaborative Agricultural Biotechnology (CABIO) Initiative will carry the lessons and success of the Agency’s previous Agricultural Biotechnology for Sustainable Productivity (ABSP) program forward while addressing changes in international dimensions of agricultural biotechnology. In addition to this RFA for the Program for Biosafety Systems (PBS), please see the accompanying RFA for the Agricultural Biotechnology Support Project (ABSP) II.

USAID has invested in biotechnology with developing country partners for more than ten years as one component of a larger strategy to increase agricultural productivity and economic growth. Adding to the weight of that experience are several international reports that note the potential contribution of biotechnology to address agricultural constraints and improve nutrition in developing countries. In July 2000, the Royal Society of London, the U.S. National Academy of Sciences, and five national academies of sciences from developing countries issued a joint report titled ‘Transgenic Plants and World Agriculture’, which concluded that developing countries stand to make significant gains in agricultural productivity from the adoption of this technology (http://www.nap.edu/html/transgenic/). The 2001 United National Development Program’s annual Human Development Report also concludes that developing countries might reap significant benefits from genetically modified foods, crops and other organisms to significantly reduce malnutrition and increase productivity on marginal lands (http://www.undp.org/hdr2001).

The CABIO Initiative is designed to address a comprehensive range of issues surrounding the development and use of agricultural biotechnology. While CABIO will consist of a number of activities across USAID’ s bureau and mission programs, it will place strong emphasis on building synergies between these efforts and promoting communication across activities to achieve a systems approach. CABIO will address the following goals:

I. Research & Technology Development: to integrate the tools of biotechnology to support agriculture, nutrition, trade, and environment objectives. These tools include genetic engineering, molecular-assisted breeding and diagnostic methods for crops and livestock.

II. Public Infrastructure Development (institutional & human capacity building and policy development): to establish the public sector framework in developing countries to support the development, use, and management of biotechnology through strengthening scientific capacity; research management; national policy frameworks, including development of effective biosafety regulations; public outreach; and promotion of linkages between public research and technology delivery or commercialization.

III. Commercial Sector & Delivery Systems: to address the delivery mechanisms for making improved technologies, such as crops improved through biotechnology, available to farmers and to build market integration of biotechnology. While the focus will be primarily on private sector delivery systems for seed or vaccines, NGO and/or public sector models will be considered as needed.

The expanded scope of activities under CABIO reflects an increased commitment by USAID to agriculture and increased opportunities and requests from our developing country partners for assistance in biotechnology. The expanded scope also provides the opportunity to more effectively integrate the tools of biotechnology into our approaches to food security, economic growth, nutrition, and environmental quality. These programs will complement other agricultural, environment and trade activities supported by USAID.

B. PROGRAM GOAL

The goal of the Program for Biosafety Systems (PBS) is to more effectively address biosafety within a sustainable development strategy anchored by agriculture-led economic growth, trade, and environment objectives. This will require a comprehensive approach to biosafety, one that looks at biosafety as a system beyond regulatory development. Through the PBS, USAID seeks to stimulate innovative thinking about new approaches to biosafety that address the range of needs in developing countries and that link policy development and formulation of regulations more explicitly to considerations of implementation. Further, through innovative research, we seek to expand the understanding of the broader relationships between biosafety policy and issues such as technology development, agricultural and food systems, and economic development. In so doing, we seek to assist our partners in understanding policy options, and impacts of those options, for integrating biosafety more effectively into sustainable development strategies.

Within the context of the second goal of the CABIO Initiative, the PBS will stress linkages between biosafety policy and the development, access, and use of biotechnology applications that will assist developing countries to improve agricultural productivity in an environmentally sustainable fashion.

C. PBS OBJECTIVES

Achieving the goal of more effectively integrating biosafety into economic development strategies will require innovative research and new approaches. Past experience by USAID and reflection on international developments in the area of biotechnology and biosafety raise the following challenges, among others, for the PBS:

· New models for biosafety systems that address issues of feasibility and the impacts of different policy options for developing countries, innovative new approaches to setting policy objectives and developing effective biosafety regulatory systems are needed. These may incorporate economic analyses of biosafety policy options, institutional analyses of existing infrastructure and technical capacities including national and regional approaches to biosafety, new tools and approaches to technical capacity building, or broadening the range of capacity building among different actors in a biosafety system.

· Developing approaches that are mutually supportive of host country and U.S. interests – including economic development, trade and environment objectives.

· Facilitating access to technology – policy research is necessary to better understand the impact of biosafety systems on access to technology by developing countries, impacts on the range of technologies needed in developing country agricultural systems, and impacts on public sector and local private sector development and delivery of technology to small farmers.

· Integration of biosafety into related policies and international obligations in areas such as food safety, environment, economic growth and food security is a consideration for national policy integration and with respect to international obligations such as the World Trade Organizations Sanitary and Phytosanitary Agreement and the Cartagena Protocol on Biosafety.

· Collaborating with USAID Missions and Bureaus or other U.S. Government and development partners for the purpose of designing new activities or contributing to short-term activities.

II. Background

A. THE ABSP EXPERIENCE

Designed in 1991, the Agricultural Biotechnology Support Project (ABSP, also known as Agricultural Biotechnology for Sustainable Productivity) was USAID’s first comprehensive and focused program in agricultural biotechnology. While designed primarily with a research and technology development goal, biosafety regulatory policy and intellectual property rights issues were integrated into the program from the start. This was in recognition of the fact that transfer and use of the technology would depend on establishment of the supporting policy framework and capacities to manage the further development of biotechnology. At the time, biosafety was not as significant a priority for developing countries themselves as scientific capacity building and technology transfer. Thus, in the early experience of ABSP, the progress of technology development under the program served as the primary motivation for progress on biosafety policy. As technologies arising from collaborative research came closer to the field-testing stage, partner countries gave higher priority to biosafety regulatory development to ensure access to technologies they co-developed and saw as beneficial. This linkage between technology and policy development under ABSP reinforced the mutual goals of the program. The types of biosafety activities undertaken by ABSP included:

· National biosafety guidelines and policy development;

· Sensitization of policy makers on issues of biosafety;

· Training of national biosafety committee members in biotechnology and risk assessment to support regulatory decision making;

· Institutional biosafety policy development for research and field testing;

· Training in the conduct of field tests under biosafety containment conditions;

· Limited infrastructure development of laboratory and greenhouse containment facilities;

· Development of a biosafety manual for training in risk assessment and risk management.

With increased focus in the international community on concerns associated with biotechnology and agreements such as the Cartagena Protocol on Biosafety, the balance of interests and the complexity of surrounding issues shifted towards a far greater emphasis on biosafety and weakened links between biosafety and the technology development process. As a result, ABSP began to undertake new approaches to biosafety, in particular two regional efforts in east and southern Africa. In East Africa, ABSP supported the Association for Strengthening Agricultural Research in East and Central Africa (ASARECA) to explore options for the definition of regional goals and the role of this regional organization of national agricultural research systems in convening a policy development process involving much broader stakeholders. ABSP will assist in the development of this regional initiative, but not its implementation. The Southern Africa Regional Biosafety training program (SARB) was a second regional initiative under ABSP in collaboration with the South African Agricultural Research Council’s Vegetable and Ornamental Plant Institute (ARC-VOPI). SARB focused on training related to regulatory implementation – risk assessment and decision making – to increase the understanding of regulatory implementation as countries were developing biosafety policies and to explore interest and commitment to a more explicit regional policy harmonization or cooperation approach.

In addition, as the technology matured in partner countries, biosafety challenges downstream of the laboratory research phase arose under ABSP such as:

· Examination of food safety policy options related to commercial approval of biotech crops;

· Identification of national or international laboratories and funding to conduct food safety analyses;

· Public outreach to address concerns about biotechnology;

· Seed and food industry acceptance of biotechnology; and,

· Media training to provide public information on biotechnology.

Additional information on the experience of ABSP can be found at the project web site: http://www.iia.msu.edu/ABSP or from the final project evaluation conducted in 2001, the report from which is attached as Appendix A to this RFA.

B. INTERNATIONAL DEVELOPMENTS TO BE CONSIDERED

In addition to the experience of ABSP, the PBS should address new developments in the international arena such as:

· Given the higher priority placed on biosafety by developing countries, many countries will proceed with policy development in the absence of significant experience or technical capacity in the sciences related to biotechnology and biosafety.

· Biotechnology applications are moving closer to entering the marketplace and farm use in developing countries, both commercial technologies such as insect-resistant cotton and technologies arising from public R&D at International Agricultural Research Centers, U.S. and other international universities, and leading national agricultural research systems.

· The complexity and costs of biosafety regulatory approval pose difficult challenges for public R&D in terms of technical capacity, laboratory infrastructure, understanding of effective regulatory systems, and funding for food safety and environmental impact studies. USAID and other donors have invested in public R&D to ensure development of a broader range of crop applications than will attract private sector investment alone.

· A broader set of stakeholders in biotechnology, including food and seed industries, the public, farmers’ organizations, etc.

· International agreements such as Cartagena Protocol on Biosafety, the elaboration of biotechnology regulations and standards under the WTO-referenced agreements Codex Alimentarius and the International Plant Protection Convention and other relevant international standards such as the International Organization for Standardization (ISO).

· Impact of biosafety on agricultural trade including exports and imports of food and commodities.

III. Biosafety Systems Approach

In supporting innovate new approaches to biosafety, particular emphasis is placed on taking a more systematic and comprehensive view of biosafety, one not limited to establishing guidelines or regulatory policies alone. Rather, considering biosafety in light of related policies in other sectors, considering the impacts of biosafety policy options and considering the diverse players in an effective biosafety system would be key issues. Below are suggested key areas with issues under each that may be addressed. Please note that alternative approaches and factors beyond these will also be considered.

A. SYSTEM COMPONENTS – are not limited to, but include the following issues of particular interest:

1. New models for biosafety regulatory systems – including both national & regional models that address the goals and objectives of the program outline in sections I and II above.

2. Policy analysis to inform regulatory development – in particular, to assess the impacts of different policy options on technology access, the types of technologies available to developing country farmers, and economic growth, food security, and environmental strategies of developing countries

3. National and regional policy development – providing sensitization and technical assistance in the development of biosafety regulatory policies in partner countries.

4. Capacity building – human and institutional development among the different actors in the system, ranging from policy makers, government regulators, scientists, farmers, etc.

5. Environmental risk assessment and risk management research – see section IV on the absorption of management of the Biotechnology and Biodiversity Interface grants program.

6. Assistance with regulatory packages – provide technical assistance to R&D institutions and regulatory agencies in the design of strategies for the regulatory approval of specific technologies in host countries.

7. Public outreach – training of policy makers and scientists in partner countries to reach out to media and other groups to address public education on biotechnology and biosafety. Note that this is also identified as a component of ABSP II and thus linkages and collaboration across these programs will be given high priority.

B. COMPREHENSIVE DEFINITION OF ACTORS IN SYSTEM

In taking a more comprehensive and integrative approach to biosafety, the Program for Biosafety Systems should seek to engage a broader set of stakeholders in policy development and address the roles and capacities of the range of actors in a biosafety system. This may include, but is not limited to:

1. Cross ministerial and cross sectoral approach – reflecting the different approaches countries have taken in who provides leadership on biosafety, as well as the important roles, interests, and relevant experience of different ministries in policy development and implementation. In addition, this cross-ministerial approach will be necessary to address relationships of biosafety policy to different sectoral strategies and to different international agreements including agriculture, health, environment, trade, and science & technology.

2. In addition to working across sectors or ministries, a comprehensive approach will go beyond just addressing policy development and the role of regulators but also include those who are regulated or indirectly affected by regulations. PBS should consider the distinct roles and needs of different actors in the system, including, but not limited to:

· policy makers

· regulators

· national and international public R&D institutions

· agrifood industries (including seed industry)

· farmers

· public.

C. FRAMEWORK FOR SERVICE TO CABIO

It is envisioned that PBS will provide a global framework for development of new tools, methods, and experience that may be applied to other USAID efforts under the CABIO Initiative. Under this model, the Program for Biosafety Systems should consist of both global activities and country or region-specific implementation (elaborated in Section VI). Among the types of global activities may be:

· Training courses

· Development of manuals or other information technology

· New models

· Policy analysis to inform decision-making

· Technical assistance for short-term activities.

In addition, it is expected that implementation may include country or regional specific application of these tools and activities that address the specific needs of the partners. A small portion of program funds should be set aside for technical assistance to USAID Bureaus or Mission to develop new activities and associate awards, to other U.S. government activities related to biosafety issues, or to develop new partnerships with other donor programs.

IV. A Special Note on the Incorporation of the BBI Program

In FY01, USAID launched a new competitive grants program, the Biotechnology and Biodiversity Interface grants program, or BBI. The BBI program supports research that provides information needed to assess the potential risks to natural biodiversity associated with agricultural biotechnology and to design risk management strategies appropriate to developing country agricultural systems.

The primary goals of the BBI program are:

1) To assist regulatory bodies in making science-based decisions about the effects on biodiversity of introducing genetically engineered organisms into the environment.

2) To begin generating scientific data on potential risks associated with particular applications of biotechnology on specific aspects of biodiversity in developing countries.

3) Develop strategies for managing potential risks in the context of agroecosystems found in developing countries.

4) Build collaboration between agricultural research and environmental conservation communities in the U.S. and developing countries.

5) To build capacity among developing countries in risk assessment and risk management research.

To both reduce the management burden of this program and to leverage the linkages between BBI and the new program described here, USAID seeks to integrate the management of BBI under the PBS. Under this arrangement the grantee of the PBS would be expected to issue an annual call for proposals under BBI, to engage external technical review in the determination of awards, and to issue sub-grants for each of the BBI awards. It is expected that there will be 3-5 sub-grants each year under this BBI component of the PBS. In the context of the cooperative agreement arrangement of PBS described in section VI, USAID’s Office of Agriculture and Food Security, and the Office of Environment and Natural Resources, will remain engaged in review of the priorities listed in the annual RFA and in review of proposals submitted under the BBI component. USAID will maintain authority for final approval of grants awarded under this activity. For your information, a copy of the BBI RFA issued in FY01 is attached to this RFA as Appendix B. It is expected that in subsequent years, priorities under the BBI program will be correlated with research and technology development supported by the ABSP II Program and other USAID biotechnology activities such that the ecological research supported under BBI will provide a foundation for the biosafety review of USAID-funded research.

V. Partnerships

The PBS will address a broad range of issues and support a comprehensive scope under the CABIO Initiative. It is expected that the PBS will require a broader range of expertise, perspectives, and resources than may be found in any one kind of institution, leading to a partnership approach both within the one program and as the PBS relates to other programs under CABIO.

A. PARTNERSHIPS WITHIN PBS

Considering the range of issues outlined above that comprise an integrated approach to biosafety, it is anticipated that the PBS will be implemented by a consortium of different institutions including, but not limited to U.S. universities, U.S. regulatory agencies, international research and policy institutions (including those from other developing countries), non-governmental organizations, other development organizations, and individual consultants. The lead institution on the PBS may represent any one of these types of institutions.

With respect to developing country partners, USAID seeks to emphasize their central role and responsibility for strategic decisions. Thus, we will place high priority on engagement of host country institutions as full partners in the program, not solely as recipients of technical assistance. In addition, creative partnerships that take advantage of expertise and experience of other developing country institutions or individuals will be of interest.

Finally, USAID seeks a partnership approach that will adapt over time as new countries or issues related to the program goal and objectives evolve into the program.

B. PARTNERSHIPS ACROSS CABIO

As presented in the first section of this RFA, the PBS is one component of the integrated CABIO Initiative. USAID seeks mechanisms to leverage experience and impacts across the various efforts in CABIO. These include linkages between PBS and ABSP II such as seeing that the technical expertise in biotech developed by host country scientists developed under ABSP II is leveraged to promote science-based biosafety policies. Similarly, policy analysis under IBS can examine the potential impact of access to or commercialization of particular technologies developed under ABSP II or the Commercial Sector activities to be developed at a later date.

In addition to these new activities, USAID will seek linkages to other CABIO Initiatives in research innovation supported by EGAT/AFS, other bureaus, or our Missions. For example, USAID is currently in discussions with the Rockefeller Foundation in support of the development of the African Agricultural Technology Foundation (AATF) that will provide strategic management of projects that involve donation of technology from industry for the benefit of Africa. Among the issues the AATF will provide assistance with is the development of regulatory strategies for biotechnology applications as a means of addressing legal, liability, and product stewardship concerns surrounding biotechnology. As the AATF develops in the coming year, linkages between this service and the capacity building efforts of the PBS will be sought.

To achieve these linkages and cross fertilization, proposals in response to this RFA and that of ABSP II should specifically address mechanisms for cross-program service and communication. In addition, the Agency will be developing approaches such as regional or subject-matter partnerships meetings on biotechnology issues. Finally, to provide strategic direction to USAID across the diverse programs under the CABIO Initiative, USAID will establish a Biotechnology Advisory Board that will hold annual meetings to examine issues and progress across activities.

VI. Target Countries & Regions

Through a combination of core funding from EGAT/AFS and Missions and regional bureaus, the leader program will address two geographic regions – Asia and Africa – though it is anticipated that additional countries and regions will be added through associate awards over the life of the program. Proposals should address these core regions while balancing the country/regional specific activities with developing new tools and approaches that have global relevance and can be adapted to new partners and countries as associate awards may be added. The specific needs and activities in each country may be elaborated in more detail in the annual work plans, once the program has been initiated and more time has been allotted for dialogue between the international and host country partners. It is also recognized that all the host country partners may not be identified in the short time of this RFA. Proposals should address a process for how partners will be identified and consulted and the types of partners that will be considered.

A. ASIA LEADER PROGRAM

In collaboration between EGAT/FAS, the Asia/Near East Bureau, and country Missions, the leader program for Asia will address the following countries:

• Philippines
• Indonesia
• India
• Bangladesh

Proposals may take the form of regional, or sub-regional (e.g. pairs such as India/Bangladesh and/or Philippines/Indonesia), a country-level approach, or some hybrid of regional and country-level activities. Considering the state of biosafety development and experience differs among these countries, it is expected that the specific activities may vary among them. Hybrid approaches that incorporate sub-regional or regional activities as a means of promoting policy dialogue or sharing of experiences may be considered. The funding level for each country may vary and the annual work plan will be approved in consultation between EGAT/AFS and the Missions in these countries.

These same countries and region has been identified under the ABSP II leader program. Cross-project activities and linkages will be sought to leverage the relationship between the science and technology and policy development.

B. AFRICA LEADER PROGRAM

Through funding from both EGAT/AFS and the Africa Bureau, the leader program will include two regional efforts in Africa:

• East Africa and
• West Africa.

USAID is specifically seeking development of sub-regional approaches to biotechnology in Africa to complement the Agency’s ongoing investment in sub-regional agricultural organizations to promote greater dissemination of technology and make effective use of scarce donor and African resources. The specific goals of a sub-regional approach may be defined in terms of regional training activities, policy analysis to support regional decision making, regional regulatory harmonization, regulatory cooperation, formal inter-government agreements or other strategies. Which option(s) one may take on a sub-regional basis will need to involve priority setting and commitments by both national and sub-regional partners. Through separate efforts, USAID is supporting regional biotechnology priority setting and research through two sub-regional organizations: the Association for Strengthening Agricultural Research in East and Central Africa (ASARECA) and Conference des Responsables Africains et Francaise de la Recherché Agronomique (CORAF) in West Africa. Other regional stakeholders in aspects of biosafety include trade and economic agreements, biotechnology advocacy groups, and seed associations.

The PBS should develop methods, tools, and approaches that provide a framework not only for these leader-program targets, but that provide a framework for addition of specific Mission-funded associate awards and exploration of efforts in Southern Africa in future years.

C. FUTURE MISSION OR BUREAU ASSOCIATE AWARDS

It is expected that in addition to the leader program targets above, additional regions or countries will be added in response to associate awards.

VII. A Note on Leader/Associate Cooperative Agreements

A. LEADER/ASSOCIATE MECHANISM

The Leader with Associate (LWA) form of a cooperative agreement was introduced by USAID several years ago to provide additional flexibility in the Agency’s procurement mechanisms. The benefit of the LWA is to provide the opportunity for Missions or regional bureaus to support specific activities within the broader scope of the Leader cooperative agreement and to maintain specific reporting by the Leader against that specific scope of activities. While it is expected that the EGAT Bureau will still provide technical oversight to most associate awards due to the lack of biotechnology expertise in Missions, the LWA mechanisms does give Missions or regional bureaus greater flexibility in integrating biotechnology and biosafety into their agriculture, environment, or economic growth strategies.

While the Leader award is a cooperative agreement, any Associate awards from Mission or other USAID offices may be awarded as a cooperative agreement or as a grant. There would be neither an additional competition requirement not pre-established dollar ceiling on Associate awards. The Mission or USAID bureau office that funds the award would manage each Associate award though they may seek technical assistance from the EGAT Pillar Bureau to complement their management capacity.

In addition to an expected $15 million over five years in core funding from EGAT for the Leader program, it is anticipated that Associate awards of up to $15 million over a period of five years may be made. The amount and extent of Associate awards are unknown, and there is no overall limit on them. Associate awards may be made for any length of time and at any time during the program until the Leader award expires June 30, 2006. Associate awards may be issued until the Leader award expires. It is necessary for the Leader award to continue in force until all the Associate awards are completed since the Associate awards will not contain separate standard provisions. Instead they will be subject to the provisions of the Leader award.

B. SUBSTANTIAL INVOLVEMENT UNDERSTANDING

The cooperative agreement mechanism provides substantial involvement by USAID during implementation of the PBS. The USAID Cognizant Technical Officer (CTO) for the PBS will be substantially involved in the following areas:

· Annual Work plan/Revision – The USAID CTO will be consulted during the development of the annual work plans and their revision and has the right of final approval. The CTO will also consult with Missions or other Bureaus engaged as part of either the leader or associate awards before approval of work plans. Work plans should include a description of annual activities, timeframe, and planned achievements against the program objectives.

· Key Personnel – The USAID CTO will be consulted and have the right-of-approval for the designation of key positions and appointment of key personnel, including at the lead institution and significant partner institutions in the program.

· Monitoring and Evaluation – The USAID CTO will be consulted during the development of monitoring and evaluation plans, including advisory bodies established under the program for this purpose, and have the right of final approval.

VIII. Prohibited Activities

Due to legislative restrictions on USAID activities, the following provisions will be incorporated in the LWA cooperative agreements to be issued:

1. The recipient shall not use, expend, or otherwise utilize funds obligated hereunder to engage in any testing or breeding feasibility study, variety improvement or introduction, consultancy, publication, conference, or training in connection with the growth or production in a foreign country of an agricultural commodity for export which would compete with a similar commodity grown or produced in the United States, excepting activities designed to increase food security in developing countries where such activities will not have a significant impact on the export of agricultural commodities of the United States, or research activities intended primarily to benefit American producers.

2. The recipient shall not expend or otherwise utilize funds obligated hereunder to provide (a) any financial incentive to a business enterprise currently located in the United States for the purpose of inducing such an enterprise to relocate outside the United States if such incentive or inducement is likely to reduce the number of employees of such business enterprise in the United States because United States production is being replaced by such enterprise outside the United States; (b) assistance for the purpose of establishing or developing in a foreign country any export processing zone or designated area in which the tax, tariff, labor, environment, and safety laws of that country do not apply, in part or in whole, to activities carried out within that zone or area, unless the President determines and certifies that such assistance is not likely to cause a loss of jobs within the United States; or (c) assistance for any project or activity that contributes to the violation of internationally recognized workers rights.

3. The recipient shall not expend or otherwise utilize funds obligated hereunder for any activity that may have a significant effect on the environment without further environmental review and approval by USAID. In particular, any activities that involve the transfer or testing of genetically engineered products must comply with the Agency’s biosafety policy.

IX. PREPARATION OF APPLICATIONS

Submit one (1) unbound original and five (5) copies of proposal typed using single-spaced, no smaller than twelve (12) point font with one (1) inch margins, on single-sided paper.

A. Cover Sheet (1-2 pages) which states the following:

· Title of RFA

· Name (and country if not apparent from name) of all organizations in partnership; include names of key individuals if identified based on specific expertise

· Name and contact of proposed program director at lead institution. All further correspondence will be with this individual unless otherwise designated.

B. Executive Summary (1-4 pages) with the following:

· Summary of biosafety systems approach;

· Summary of partnership approach;

· Summary of expected outcomes at end of project.

C. Project Description (20 pages maximum) which addresses the following:

· Section II and III of this RFA or additional innovative ideas in biosafety that address Goals and Background in sections I and II.

· Approach to each of the Leader countries/regions discussed in section V of this RFA.

D. Expected Outcomes (5 pages maximum), including addressing the following:

· Specific proposed intermediate project milestones, end of project outcomes, and longer-term (i.e. after project completion in some cases) impacts;

· Timetable for reaching milestones;

· How these will support the goals and objectives in section I of this RFA.

E. Lead Institution (1-2 pages), including addressing:

· Biosafety expertise with a discussion of which specific aspects of biosafety it has expertise;

· Demonstrated capacity to manage international development programs.

F. Other U.S., International, and Host Country or Regional partners (5 pages maximum); for each discuss

· Role in program with reference to the proposed biosafety system;

· Specific aspects of biosafety expertise;

· Experience in international development programs.

G. Management structure (2-3 pages), including addressing:

· Staffing at lead institution;

· Structure and approach to relationships with other U.S., international & host country partners;

· Monitoring and review strategy, including use of technical advisory committees, etc. - how will decisions be made internal to the program on which activities are successful, what should be expanded or cut based on performance, etc.

· Approach to interaction across CABIO Initiative.

H. Budget Summary (2-3 pages)

· May include representative annual and/or life of project budget;

· Indicate any complementary funding contributed as cost sharing by partner institutions and any other federal or donor support for implementation of proposed program (Note: USAID requests some degree of cost-sharing, and strongly encourages applicants to cost-share a minimum 25% of total program cost).

I. Annexes

1. Certifications and SF424

Applicants are requested to submit the Certification (see Appendix C to this RFA) and SF424 (in addition to budget summary above). Note: USAID requests some degree of cost-sharing, and strongly encourages applicants to cost-share a minimum 25% of total program cost. See the following USAID web page to download the SF424: http://www.usaid.gov/procurement_bus_opp/procurement/forms/SF-424/. Please make sure sufficient budget narrative (purpose and basis) and breakdown of costs, for all five years of the proposal, are submitted with the SF424 to determine cost reasonableness.

Please indicate concurrence to standard provisions that can be viewed at USAID website http://www.usaid.gov/publs/ads/300/303.pdf.

2. Letters of support from partners and any other organizations such as USAID Missions, other donors, or groups working in this area.

X. Selection Criteria

A. Systems Framework Design (40 points)

· The extent to which the proposed approach addresses the range of components and players in the development and implementation of biosafety systems;

· The extent to which the proposed approach links issues and implications of a biosafety system across different sectors;

· The feasibility of the approach;

· The degree of innovation of the proposed approach.

B. Strength of the Partnership (30 points)

· Role in program (with reference to goals) of lead institution and other U.S. or international partners;

· Role in program (with reference to goals) of host country or regional partners;

· Diversity of expertise in agricultural biotechnology and experience in international development program of lead institutions and partners;

· Management structure and strategy.

C. Potential to Create an Enabling Policy Environment (30 points)

· Capacity building strategy

· The extent to which the proposed activity is relevant to USAID goals and objectives;

· The extent to which the proposed regulatory approach will be feasible for developing countries to implement;

· Consideration of economic implications or other impacts by the proposed approach.

· Support of U.S. and host country mutual interests.

XI. Submission of Application

Applications in response to this RFA should be submitted according to the format described in section VII. The EGAT Bureau should receive one unbound original and five (5) copies [for a total number of six (6)] by 5:00 pm EST on May 31, 2002. Applications should be sent to:

By Mail: By Courier/Express Mail:

PBS PBS

Attn: Josette Lewis or Attn: Josette Lewis or

Bhavani Pathak Bhavani Pathak

USAID USAID

EGAT/AFS EGAT/AFS Rm 2.11-052

Washington, DC 20523-2110 Ronald Reagan Building

1300 Pennsylvania Ave, NW

Washington, DC 20005

Phone (202)-712-5592/(202)-712-4939

XII. Questions Regarding RFA

Any questions related to this RFA should be submitted in writing on or before April 26, 2002 via fax or email (no postal correspondence please) to:

Josette Lewis, Ph.D.

Senior Biotechnology Advisor

USAID

Rm 2.11.052

Fax: 202-216-3579

Email: [email protected]

or

Bhavani Pathak, Ph.D.

Biotechnology Specialist

USAID

Rm 2.11.053

Fax: 202-216-3579

Email: bpathak@usaid.gov

All written questions will be answered and made available to the public on or before May 10, 2002.

APPENDIX A – ABSP EVALUATION

FINAL PROJECT EVALUATION

Project Title: ABSP: Agricultural Biotechnology Support Project

Project Number: 936-4197

Name of Grantee: Michigan State University, East Lansing, MI

Cooperative Agreement No.: DAN-A-00-91-00126-00

Project Director: Catherine L. Ives, ABSP, Michigan State University

Tel: (517) 432-1641, Fax: 353-1888, [email protected]

USAID Project Contact: Josette Lewis, Biotechnology Officer

EGAT/AFS

USAID, Washington, DC 20523-2110

Tel: (202) 712-5592, Fax: 216-3579, [email protected]

Review Team: Carliene Brenner, Consultant in Emerging Technologies

Paris, France

Maria Jose Sampaio, IPR and Biotechnology Advisor EMBRAPA, Brasilia, Brazil

Ana Maria Sittenfeld, Associate Professor

Center for Research in Cellular and Molecular Biology, University of Costa Rica, San Jose, Costa Rica

Ann Marie Thro, National Program Leader-Plant Genetics

(Team Coordinator)

USDA/Cooperative States Research, Education, & Extension Service, Washington, D. C., USA

Site Visit Dates: June 9-15 and July 9-18, 2001

Sites visited: Michigan State University, Lansing, Michigan

Cornell University, Ithaca, New York

AGERI, Cairo, Egypt

Various sites, Indonesia

Report date: October 29, 2001

TABLE OF CONTENTS

SECTION PAGE NUMBER

Executive summary 20

1. B<DIV><SPAN class=950194810-20072001>ackground 30

2. <DIV><SPAN class=950194810-20072001>Research 34

3. <DIV><SPAN class=950194810-20072001>Policy 41</SPAN></DIV>

4. <DIV><SPAN class=950194810-20072001>Technology Transfer and Commercialization 46

5. </SPAN></DIV><DIV><SPAN class=950194810-20072001>Communication and Networking 50

6. <DIV><SPAN class=950194810-20072001>Management 53      </SPAN></DIV>

7. <DIV><SPAN class=950194810-20072001>Budget and Buy-ins 60 </SPAN></DIV>

8. <DIV><SPAN class=950194810-20072001><DIV><SPAN class=950194810-20072001>References 63

9. List of Acronyms 64

EXECUTIVE SUMMARY

INTRODUCTION AND OVERVIEW

The present document represents the findings and recommendations of a comprehensive external evaluation of USAID’s flagship effort in agricultural biotechnology over the last decade. ABSP was a bold and original effort to empower developing countries to capture new technologies for their own purposes, understand and manage new issues, and so enter a new era in their agricultural development. The project planners were the first to foresee these needs, or certainly, the first to undertake a development project that attempted to meet them.

In 1991, any project such as ABSP that hoped to have transgenic products for commercialization within six to ten years, had no choice but to use “on-the-shelf” technologies in situations where these could meet a need. By 2001, both the scientific and political landscapes in agricultural biotechnology applications changed dramatically. So fast has the science evolved, that most crops can be transformed successfully, and gene discovery in a reasonable time frame seems feasible for many situations (NSTC, 2000). A follow-on project to ABSP will have unprecedented biological opportunities to provide useful technologies. This will be extremely important in the next decade, when the development community focuses hard on the problem of improving food crop productivity and economic opportunity in areas, such as Africa, where it has stagnated or declined, and if adaptation to climate change requires new crop germplasm everywhere.

The external environment for transgenic technologies, however, has become more complex. For a kaleidoscope of reasons beyond the scope of this review, opposition to transgenic products has closed certain markets to transgenic products, at least for the time being --markets that developing countries hope to access. Regulatory regimes for environmental and human health and food safety are creating the need for sophisticated review processes and imposing very high costs -- hurdles that are the most difficult for the countries most in need of new tools for food security and development. A follow-on project will also have great challenges in supporting countries’ efforts to bring biotechnology products to market successfully.

These technological opportunities and policy challenges are precisely the reasons why the common goal of ABSP--to demonstrate the value of transgenic technologies for development--remains in need of a long-term, responsive, and flexible project, with ever-closer involvement of stakeholders in the developing country partners as well as the United States.

Because ABSP was in many ways a pioneering and unique project, the primary purpose of the evaluation was to highlight its most successful practices and innovations, i.e., aspects any follow on project would do well to emulate, from those that were not effective and which a follow-on project should correct. A second purpose of the review was to identify major strengths and weaknesses in the way in which ABSP carried out the agenda set forth in the project documents.

MAJOR ACHIEVEMENTS OF ABSP

· Innovative linkages: The project forged private-public, public-public, and private-private linkages successfully. This created enabling environments in developing countries for the application of modern agbiotech in developing countries. With more business management expertise, these could have gone even farther. The lessons learned could prove highly valuable to future projects, both international and domestic.

· Created positive awareness of biotechnology in developing countries, and highlighted the importance of policy aspects in planning research activities, particularly in collaborative projects.

· Successfully fostered the development of high-quality national biotechnology research expertise in Egypt and Indonesia.

· Provided integrated approach protocols and methods for biotechnology policy development to a wide range of relevant officials in developing countries.

· Time frame: The project time frame was long enough for the project to use lessons from its own experiences to improve project design.

· Maintaining continuous and effective communication with USAID.

· Forward-looking policy activities Phase II should provide a foundation for further USAID collaboration, particularly in Africa.

SHORTCOMINGS OF ABSP

· ABSP's own learning curve in managing product development and biotechnology policy:

Ø IPR audits, risk assessment protocols, and biosafety/food safety data collection were begun late on promising research products closest to the market,

Ø Continued funding for projects not likely to support ABSP’s goals of product development-related research.

· Weak tools for (sub-) project selection and evaluation; breakdowns in effectiveness of research monitoring and accountability mechanisms -- for a range of reasons, some beyond the project’s control.

· The choice of research objectives, especially in Phase I:

Ø Based on a biological assessment of needs and opportunities, but with need for more use of socio-economic, market and other analyses appropriate to a project targeted at ultimate commercialization,

Ø Need for more national stakeholder participation in priority setting.

ABSP PROJECT BACKGROUND

In 1990, as part of designing a new program in agricultural biotechnology, USAID called upon the National Research Council (NRC) of the U.S. National Academy of Sciences for assistance in identifying priorities for an international biotechnology development program. The NRC panel recommended equal weight on addressing institutional management issues, such as intellectual property rights (IPRs) and biosafety, research and technology development, and private-public or private-private sector linkages.

Building upon these recommendations, USAID designed the Agricultural Biotechnology Support Project (ABSP) to integrate policy with research and training. The project would bring together public sector and commercial research with the long-term goal of increasing incomes of the poor, and expanding availability of food while maintaining sustainable productivity. It would achieve this through mutually enhancing U.S. and LDC institutional capacity for use and management of biotechnology to develop environmentally compatible, improved germplasm. During the anticipated six-year project life, it was to move from the research and development stage to field testing of potential products.

In September 1991, a cooperative agreement for ABSP was awarded to Michigan State University (MSU), as a consortium of public sector institutions and private companies in the United States and developing countries. ABSP’s scientific objectives included transfer of host plant resistance genes into developing country crops. Training of scientists, administrators, and policy makers in biosafety procedures and intellectual property rights was an important priority.

In 1998, ABSP was granted a non-competitive extension (Phase II) to continue until 2002. The primary goal of Phase II was to move to move promising transgenic research to field-testing and initiate the registration process in developing countries. An additional goal was to build on the policy training of Phase I, to help improve the capacity and policy environment for management and commercialization of agricultural biotechnology in developing and transition economies.

RESEARCH

ABSP is to be recognized as a unique program for its use of innovative approaches in both the scientific procedures used, and the structure of research collaborations implemented between public and private sector institutions in the US and developing countries. By coupling these interactions with investments in infrastructure and capacity building, ABSP created environments in developing countries capable of producing world class scientific research. In many cases, scientific research also stimulated policy activities leading to the creation of necessary frameworks to support biotech commercialization. The main research developments occurred in the production of improved micro-propagation methods, and genetically modified plants resistant to pests, diseases, and drought, and tolerant to salinity.

POLICY

ABSP today is a radiograph of what now seems so obvious: issue awareness and capacity building, research and policy developed side by side. However, ten years ago it took sharp insight to propose and implement such a design. USAID, through ABSP, has promoted science development and technology transfer, both direct and indirect; helped increase awareness of biotechnology, and developed of political, philosophical and practical aspects of both intellectual property and biosafety issues surrounding the use of transgenic crops.

TECHNOLOGY TRANSFER AND COMMERCIALIZATION

ABSP has been highly successful in some aspects of technology transfer. Its achievements have been notable in the following areas: training and research collaboration, particularly with private sector partners; helping to create an enabling environment in developing country partners for the transfer of materials for research and testing purposes; and creating innovative technology transfer institutions in Egypt and Indonesia. It has not, however, succeeded in the key objective of bringing a transgenic product to the stage of commercialization.

COMMUNICATION AND NETWORKING

Perhaps the most notable overall achievement of ABSP in communication and networking is that it raising awareness on a range of issues associated with agricultural biotechnology, not only in participating countries, but also in other developing countries. These issues include not only the potential of biotechnology to contribute to problems confronting developing country agriculture, but also potential risks associated with its use, and management of these risks.

MANAGEMENT

ABSP management did an excellent job of balancing research and policy aspects throughout the project; of enlisting private sector partners despite different private vs. public sector cultures and practices; and of sustaining the visibility of the project’s unique goals. ABSP management also maintained a constructive relationship with USAID throughout the project. The design of new projects as ABSP progressed showed that management actively learned from its own experience with the new forms of research partnerships it encouraged (for example, compare the structure of the later Pioneer/AGERI project with the earlier ICI/Indonesia project). These lessons will be invaluable to any follow-on project receptive to the experience of ABSP. Management structure was clarified in Phase II, and in anticipation of a recommended reduction in management activity, staff was reduced. However, numerous activities continued in Phase II, and in some areas even increased, leading to management over-extension. In addition, in both phases, expertise in business development was recommended for the management team but not obtained, and strong technical review and accountability mechanisms were lacking. These problems impacted ABSP’s ability to make targeted decisions about resource allocation.

BUDGET AND BUY-IN

ABSP’s planned Phase I core budget was drastically cut just at the time that start-up activities were scheduled to expand. ABSP management showed energy, persistence, and persuasion to have been able to attract and retain capable partner institutions in an atmosphere of chronic financial retrenchment and unpredictability.

In general, ABSP benefited from the additional funds contributed by USAID country missions. When buy-in funding in Phase II, in particular, emphasized research, ABSP management maintained overall balance by using core funds for policy development activities. However, management's ability to require accountability for technical progress in the buy-in research projects, and for adherence to ABSP's product development goal, was undermined. Country missions did not have technical capacity to do reviews to require accountability from biotechnology research.

RECOMMENDATIONS

A. SHORT TERM (for the final phase of ABSP)

Research

· Immediately revisit the potato project in Egypt and the cucurbit project in several countries to ensure that investment is not lost. There is a need to focus on research issues related to product development, such as adaptation of transgenic lines to tropical environments, and evaluation of agricultural performance at different sites in developing countries.

· Increase the number of publications from research activities. In particular promote joint publications by scientists from the US and developing countries. Such publications should include documentation of the learning experiences of ABSP, to extend benefits of lessons learned beyond the immediate participants.

· Revisit those projects where the research is too ‘upstream’ to provide results to a developing country in the time frame of ABSP, and make go/no go decisions based on recommendations from a TAG review.

· Conduct ecological assessment, gene flow analysis and food safety research for transgenic potatoes and cucurbits.

Policy

1. Intellectual Property (IP) Rights:

· Make arrangements for freedom to operate (FTO) with all components of on-going projects.

· Out-source with private IP offices experienced in working with developing countries to review FTO of IP-protected components and implement license agreements required for the continuation of on-going projects linking those with pre-market analyses (royalty & mile-stone payments).

2. Biosafety:

· Develop cost estimations of biosafety risk assessment, management and communication as part of the project, on a case by case basis.

· Review/start developing food and environmental safety data for individual products which are on the verge of reaching the commercial phase.

· With specialists, review country food and environmental safety protocols to identify adaptations appropriate to LOCAL conditions.

· Organize short seminars on practical aspects of environmental and food safety, for lawyers, politicians, policy makers, NGOs and other players.

Technology Transfer and Commercialization

· During the time that remains, effort should remain focused on achieving, to the extent possible, the objectives set in Phase II of the project. This would involve, in particular:

Ø Resolving the situation in Indonesia regarding approval for the multi-location trials for transgenic potato,

Ø Taking decisions regarding future options for commercialization of products generated by AGERI.

· Ensure that the relevant socio-economic studies are conducted in the case of the High Beta-Carotene Mustard project, to determine how development and delivery costs will be met, and by which public or private sector partners.

Communication and Networking

· In the time remaining, it is important that, to the extent possible, a proper balance be maintained between:

- Ensuring that the project remains focused on achieving the objectives set but not yet met,

- Maintaining communication with a growing number of partners,

- Consolidating the results and lessons to be drawn from the life of the project.

· ABSP should publish, in a widely accessible format, a description and analysis of the cumulative "lessons learned" by ABSP management, particularly lessons learned in private-sector collaborations.

· USAID should organise a final international workshop. Such an event, the proceedings of which would be published, would help determine the directions of a new program and would, at the same time, be a fitting concluding event of the ABSP program.

Management

· Obtain business development expertise to assist in the development of socio-economic and business plans for ABSP products close to the market (see recommendations for Technology Transfer and Commercialization).

B. LONG TERM (for future projects)

Research

· Research projects within larger composite projects such as ABSP should be selected and approved on the basis of competitive calls for proposals and a peer review recommendation process in both U.S. and developing countries.

· Implement effective systems for evaluation and scientific accountability, including incremental reviews to permit adjustments in the course of research plans.

· Prioritise research objectives giving stronger weight to country needs -- this has become more feasible due to scientific advances since the ABSP project was designed in 1991.

· Continue and increase private-private collaboration, and facilitate industry internships for senior scientists from public institutions to private sectors. Include the nurturing of weak local seed industries as an objective in these partnerships.

· Include food safety research, ecological assessment, and risk management for tropical areas (see also “Policy”).

· Create stronger links with other biotechnologies such as molecular genetics, and stronger links with applied breeding to ensure that research products are ultimately presented to farmers and consumers in desirable varieties.

· Reduce investment risk by creating a balanced portfolio of projects, including transgenic technologies and molecular biology, in support of classical plant breeding methods in export and local crops. This may afford opportunities to interface with other USAID projects.

· Increase frequency of meetings to promote detailed discussion of scientific programs, especially for planning experimental details (see also “Management”).

· Continue and increase capacity building for developing research institutions in developing countries capable of independently identifying needs and performing research.

· Include research programs that consider mix crop-livestock systems and livestock diseases. This will be timely in light of the projected increase in demand for meat and milk over the next two decades in developing countries.

Policy

1. Intellectual Property Rights:

· Develop strategic planning of the IP platform needed for individual products before project starts.

· Map out the ownership of a set of most useful tools and components and provide this information to biotechnology users.

· Review and expand the IPR course to include technology transfer offices, and management and implementation of PVP laws (UPOV-like model).

· Expand participation in these courses to include judiciary systems of developing countries.

· Develop case studies e.g. transfer of genes and processes covered by third party IPR - practical applications.

· Develop model contracts and model material transfer agreements to provide to partners.

2. Biosafety:

· Continue to provide funds for specialized biosafety infrastructure.

· Review the available “tool boxes” for engineering new products, in accordance with the latest safety requirements.

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· Expand the biosafety course to include the design of food and environmental safety protocols for model products adapted for specific regions of the globe.

· Audit laboratories for best practices and international certification.

Technology Transfer and Commercialization

· If collaborative research, technology development and transfer are to be successful, the choice of research techniques, technologies to be developed and choice of crops should be decided mutually between research institutions in the United States and developing country partners.

· Socio-economic analysis should underpin the choice of research projects and technology development. At the very least this would involve analysis of market conditions and prospects.

· Funds should be allocated for the "development" (lab to small and large-scale testing) phase of R&D.

· Retain and increase the Competitive Small Grants program, for both public and private sector partners, for research, pilot development and marketing projects.

· Research teams should include a socio-economist or market analyst.

Communication and Networking

· In any future project, networking resources should be provided to bring all participants together on a regular basis to report on their work and discuss technical and policy-related issues of common interest.

Management

· Include professional business development expertise in the management team from the beginning.

· Continue an external Technical Advisory Group (TAG) to monitor and advise on progress.

· Design robust mechanisms for monitoring and accountability based on realistic understanding of both USAID and cooperating institution requirements and constraints.

· Use a uniform reporting format with short "highlights" sections on progress, expectations, issues, problems, and adjustments.

· Select in-country coordinators carefully and assist them to identify possible conflicts of interest to be resolved; provide funds for logistics to meet their responsibilities to the project.

· Develop a network in which participants in different research projects share responsibility for a common goal--in ABSP’s case, the goal of demonstrating biotechnology’s value for sustainable development. The management objectives here are to create self-monitoring forces through constructive peer pressure, and to empower participants to generate spin-offs.

· Give careful consideration, in the design of any new project, to balance between national and regional activities.

· USAID should provide additional support to the USAID Biotechnology Officer. This need was chronic throughout ABSP, an obstacle to the degree of contact necessary between a donor and a project as complex as ABSP. Additional support will be even more necessary in future in an ever-more-changeable technical and political environment and with increasing demands on this USAID position.

Budget And Buy-In

· USAID should seek a mechanism for protecting project core budgets, especially once commitments have been made and collaborators have begun expenditures.

· USAID should develop best-practice guidelines for interactions between global units and country missions, to obtain maximum benefits from country-specific knowledge, global perspectives, and agency investments. Projects that demonstrate exceptional synergy between country/mission objectives and global unit goals should be recognized.

Section 1. BACKGROUND

In the mid 1980's as agricultural biotechnology started to move toward commercialization in the United States, development community interest in the potential of biotechnology for developing countries also increased. The first initiative of the U.S. Agency for International Development (USAID) in the area of biotechnology was the Tissue Culture for Crops Project (TCCP) based at Colorado State University. Research sponsored under the TCCP sought to produce crops (wheat, rice and sorghum) tolerant to an array of stresses, including salinity, drought, and acid/aluminum soil conditions. As new technologies were developed, USAID began a review of opportunities to support biotechnology in 1989.

As a basis for designing a new program in international agricultural biotechnology, USAID followed the procedure used by leading domestic research initiatives, i.e. it called upon the National Research Council (NRC) of the U.S. National Academy of Sciences. The NRC was asked for assistance in identifying broad priorities for consideration in an international biotechnology development program. NCR appointed a panel of experts consisting of seven US university scientists, two representatives of the US private sector, one representative each from a private foundation and from USDA, four from international research centers, eight USAID staff members, and one representative of a developing country national agricultural research program. With the possible exception of some of the USAID members whose expertise is not given, all but one panelist were biologists. The panel met in September 1989.

The NRC panel (NRC, 1990) made recommendations regarding specific biotechnologies, objectives, and technological capacity building, but placed equal weight on the capacity to address issues of intellectual property rights (IPRs) and biosafety. The panel also suggested private-public or private-private sector linkages. Building upon these recommendations, USAID designed a program that integrated aspects associated with the dissemination and application of biotechnology, particularly management and technology transfer issues, with biotechnology research training. USAID issued a competitive call for proposals (Request for Applications: RFA No. W/FA-91-004 Agricultural Biotechnology for Sustainable Productivity (ABSP), Project No. 936-419, issued June 17, 1991, closing date July 23, 1991).

This new project was designed to bring together public sector and commercial research efforts in an integrated product-development program. The ABSP project was designed to support a program of research and development for six years at a cost of $6,035,000 of central funds. Participatory funding (“buy-ins”) from missions and regional bureaus was anticipated at $3,500,000 for a total life-of -project level of approximately $ 9.5 million. The initial funding was to:

· Increase capacity of at least two US and five LDC institutions for integrated, priority based management of projects in plant biotechnology;

· Maintain sustainable agriculture as a conceptual focal point;

· Advance human resource development;

· Advance US and LDC institutional integration and management of biotech research by providing internships and consulting in IPR and biosafety;

· Promote product development, field testing and commercialization of biotech innovations in LDCs;

· Sponsor an international biotechnology network;

· Advance two or more products to adaptation for commercialization and use.

The project anticipated the following outcomes:

· Support for the institution-building of, and research by, three laboratories/research institutions in developing countries in Latin America, Africa and the Near East;

· Further establishment of an international network;

· During the six-year life of ABSP project, move from the research and development stage toward testing, commercialization and product distribution;

· Funds for publication and distribution of newsletter/information dissemination; international conferences, internships in IPR, biosafety, and commercialization, trade memberships, legal assistance, seminars, economic marketing and feasibility studies.

Specific end-of-project status was to include:

· Centers of institutional expertise in agbiotech in developing countries;

· Two U.S. and developing country scientists will have conducted a minimum of five research projects to solve specific constraints;

· Training of one Ph.D. candidate and at least 5 post-doctoral fellowships;

· Internships in IPR and biosafety;

· Commercial and managerial linkages;

· Development of patents and licenses;

· Distribution of improved germplasm to developing countries and international centers;

· Operational network of LDC, U.S. and other research scientists.

AWARD OF ABSP AND PHASE I

Applications were reviewed by an external peer review panel selected by the NRC, and in September 1991, a cooperative agreement for the Agricultural Biotechnology Support Project (ABSP) was awarded to Michigan State University. In addition, a private sector component was awarded to DNA Plant Technologies to collaborate with Agribiotecnologia-Costa Rica on development of micropropagation techniques for coffee, banana and pineapple.

The overall goal of this phase of ABSP was to mutually enhance U.S. and developing country institutional capacity for the use and management of biotechnology research to develop environmentally compatible, improved germplasm. A major scientific goal was the transfer of host plant resistance genes into crops with major pest problems in developing countries, specifically those difficult to manage via conventional breeding. The project aimed to produce a number of transgenic crops and field-test them in the US and collaborating countries. The project also aimed to develop innovative and robust micropropagation methods. Specific research objectives were:

· To develop disease-free, high quality planting material of tropical crops, specifically banana, pineapple, coffee, and palm;

· To assemble vectors containing insect and virus-resistant genes;

· To genetically engineer potato, sweet potato, and maize for resistance to virus and insect pests in developing countries;

· To genetically engineer cucurbits with a virus coat protein for development of resistance to potyviruses;

· To transfer scientific knowledge and techniques to developing countries through postdoctoral fellowships;

· To demonstrate pest resistance of transgenic crops and integrate this into sustainable agricultural systems via collaborations.

Additionally, the training of scientists, administrators, and policy makers on the application of biosafety procedures and intellectual property rights in biotechnology was an important priority.

ABSP PHASE II

The second phase of ABSP was to emphasize transfer and commercialization of the products of Phase I research. The TAG’s mid-term report indicates the need to make a shift in goals and objectives away from research to delivery of research products, including change in management structure that will best serve the new directions of the second phase.

In 1998, ABSP was granted a non-competitive extension to continue the project until 2002. This extension was based on consultations within USAID, among the regional bureaus and the Office of Agriculture and Food Security, to meet Agency priorities for agriculture and a market orientation. Phase II had the following specific objectives:

· To improve the capacity and policy environment for the use, management and commercialization of agricultural biotechnology in developing countries and transition economies.

Indicator: Transgenic cultivars developed by ABSP or external sources (e.g. multinational seed companies), field tested and undergoing registration in host countries.

· To establish a policy framework in developing countries and transition economies which allows the effective use, management and commercialization of biotechnology by both host country and multinational agribusiness and research institutions.

Indicators:

Ø Science-based policies for IPR, biosafety and/or novel foods drafted and adopted at national and/or regional levels.

Ø Applications for field-testing and/or protection of intellectual property rights for improved and/or genetically engineered varieties handled effectively by host country regulatory bodies.

· To improve marketed crops through strategic research partnerships between the U.S. and developing country public and private sectors.

Indicators:

Ø At least two improved cultivars with enhanced agronomic qualities, and/or pest and disease resistance developed and field-tested or in the registration process in at least two host countries.

Ø Private and public sector partnerships identified and agreements signed.

These objectives would positively impact food availability, economic growth, and conservation of natural resources through agricultural development-- strategic objectives of USAID.

Three developing countries were targeted in the RFA: Indonesia, Kenya and Ecuador, however, the initial partner countries became Kenya, Indonesia, and Costa Rica. For the purpose of reference, the main country programs over the life of the project were:

Kenya: collaborative research on the development of virus resistant sweet potatoes, development of maize lines resistant to insect pests, and improvement of banana production through tissue culture.

Indonesia: policy work on intellectual property rights, including drafting of a national PVP law, technology transfer and biosafety; collaboration with ICI seeds on development of Bt maize, collaboration on the potato and cucurbits projects at Michigan State and Cornell, and a small competitive grants program to fund national research.

Costa Rica: collaboration with DNAP on micropropagation, and policy work on intellectual property rights.

Morocco: development of a national PVP law, and technical assistance and training for related implementation.

Egypt: largest program addressing research on tomatoes, cucurbits, maize, and potatoes; technology transfer and intellectual property rights at the institutional level, and biosafety at the institutional and national levels; research infrastructure development.

East/Central Africa Regional Program: technical support to a regional organization in development of a multidonor-funded program for biotechnology research, and regional biosafety policy development.

Southern Africa Regional Program: partnership with South African institutions to deliver technical training in biosafety to support regulatory development and implementation

Section 2. RESEARCH

Science and technology, policy and financial aspects have tended to determine the direction of biotechnology development and its applications. ABSP has improved research capacities, which have produced important impacts in human resource development and capacity building for modern biotechnology research in target developing countries. Main research developments occurred in the production of genetically modified plants, in areas of pest and disease resistance (Bt potato and maize and virus resistant/tolerant cucurbits, sweet potato and tomato). In addition inreased agricultural productivity, by improving micro-propagation methods for bananas, coffee, ornamental plants, and pineapple, and improved cucurbit seeds produced by traditional methods, were part of the research activities. More recently, projects were implemented to produce drought and salinity tolerance in wheat and tomato. Improved nutrient content in the form of high beta-carotene mustard oil is in early phases of research collaboration between a developing country and the U.S. private sector, with the objective of transforming local Indian mustard varieties.

If developing countries are to be able to take full advantage of agricultural biotechnology, it is important that they develop their own research capacities. In this regard, research collaborations under ABSP, involving creative partnerships between both public and private sectors in the US and in the developing countries, represent one of the major accomplishments of the project. ABSP has to be recognized as a unique program for producing new and/or adapted knowledge, technology and tools of high quality, using innovative approaches in terms of both the scientific procedures used, and the structure of the research collaborative efforts to conduct research activities within international cooperation frameworks. In addition to facilitating training, technology access and technology development by scientists in developing countries, these interactions also increased their capacity to manage the complex issues involved in the application of agbiotech. Coupled with investments in infrastructure and capacity building, targeted research institutions in Egypt and Indonesia have developed necessary skills for independently conducting world class scientific research. In many cases, scientific research stimulated and promoted policy activities, leading to the creation of necessary frameworks to support biotech commercialization.

The connections with the private sector in most cases offered the opportunity for scientists in developing countries to understand the working environment and scientific research performed at the US industry level. The private sector in many senses drives the development of new technologies in agricultural research in the US and other developed countries, and ABSP should be commended for including, since the early stages, the involvement of the private sector. Interactions with the private sector have resulted in excellent learning experiences of mutual benefit, which should be promoted. ABSP learned from experience that this requires several conditions be met including the selection of research activities of mutual interest, the presence of a champion in the private sector institution leading and coordinating joint efforts, a good understanding of developing country scientist of industry’s culture and sense of business in terms of confidentiality and IPR, languages skills and internships for a minimum of one year.

Activities and outcomes from ABSP, in general, are in agreement with the following USAID strategic objectives and goals: a) Improved food availability, economic growth and conservation of natural resources through agricultural development, and, b) Support appropriate and functioning economic policies, market reforms and institutions in selected emerging markets and priority countries.

RESEARCH REVIEW

1. Potyvirus Resistant Cucurbits

The goal of the project is to develop high quality cucurbits with multiple virus and disease resistance using a combination of molecular genetics and conventional breeding approaches. The project includes collaborative laboratories at MSU, Cornell, and several institutions in developing countries. The cucurbit project has been executed with excellent science, representing an outstanding example of a continuous line of research within ABSP. Unfortunately, the project showed poor coordination among participants at various times, therby decreasing the overall performance of the project.

The MSU group focused on the production of virus resistance through the expression of the coat protein gene (cp). Research outputs included melon and squash with resistance to zucchini yellow mosaic virus (ZYMV) using the ZYMV coat protein gene provided by MSU. Results from field trials of the ZYMV-tolerant squash lines in different locations in Egypt indicate that this research output has the highest possibilities to be the first ABSP product to reach the market place. Initial greenhouse evaluation of ZYMV-tolerant melon lines containing the cp gene of ZYMV-CT strain also showed promising results. In addition, AGERI developed an effective regeneration and transformation system for Egyptian cultivars of watermelon, using the coat protein for Water Melon Mosaic Virus (WMV). AGERI also reports having successfully established a regeneration and transformation system in the Beit Alpha open field cultivar of cucumber.

Breeding cucurbits for multiple virus resistance at Cornell University included, 1) large scale greenhouse and field-based screens of advanced cucurbit varieties with multiple resistance to four major viruses and other two fungal diseases, and 2) identification of lines closest to commercial type which contain the broadest spectrum of disease resistance. Research outputs included squash, cucumber, tropical pumpkin and melon. Seeds were distributed to Egypt, Jordan, South Africa, the Philippines, Indonesia, South Africa, and Brazil. The Cornell group has provided germplasm to companies and institutions operating all over the world using simple licensing and material transfer agreements. The group had difficulty in follow up and back reporting systems with international collaborators. Poor agronomic performance in some of the virus-tolerant lines, when tested in tropical countries, reflected the need to put more emphasis on cooperation with national plant breeding efforts in adapting improved germplasm to tropical conditions.

A major objective in the last years is the development of a novel non-regeneration dependent system for cucurbits. Although trying to solve issues related to non-regeneration systems is at the forefront of science, in view of the time frame indicated for ABSP termination in 2002, and the reduced funding situation, there is a high possibility of leaving incomplete results in this area. Focusing on research issues related to product development at the end of the project, such as adaptation of improved germplasm to tropical environments, and evaluation of agricultural performance at different sites in developing countries, could have being more productive and in agreement with ABSP goals and indicators approved under Phase II of ABSP.

2. Potato Tuber Moth Resistance

Potato research has focused on the development of Bt transgenic potato germplasm for resistance to the potato tuber moth, which has to be recognized for being the first transgenic product the research team field-tested. Following a recommendation from the ABSP Technical Advisory Group (TAG), initial problems such as the use of unmodified wild Bt was replaced by synthetic cry V. This posed other problems in terms of IPR and food safety. Negotiations to obtain FTO have proven to be difficult, and food safety experiments started only recently, indicating that AGERI and MSU in this collaboration have demonstrated a strong scientific culture, but a less developed sense of market orientation in their research. Moreover, difficulties in the distribution of the transgenic lines are anticipated, in view of the current situation in Europe, an important market for potatoes produced in Egypt. European non-acceptance of transgenic crops reached a degree that few anticipated. This is an external factor that ABSP could not have prevented. Indeed, had there been more projects with similar goals of proving the value of these technologies in the developing countries and of facilitating policy development in these countries, support for using transgenic technologies might be stronger today.

In Indonesia, field-testing is pending approval from the Indonesian and USAID Biosafety Committees. ABSP is continuing to work with Indonesia and USAID to receive approval for field-testing. Similar efforts to test Bt potatoes are in process with CIP in Peru.

The Agricultural Research Center (ARC) of South Africa expressed interest in testing material in South Africa, and in December 1999, an MTA was developed to facilitate transfer of 12 Bt transgenic potato lines (tissue culture plantlets) from MSU to South Africa for greenhouse and field evaluations. Approvals for field-testing from the appropriate regulatory authorities were obtained and field trials are planned for late 2001.

3. Gemini Virus Resistant Tomato

The initial phases of this project were performed at the International Laboratory for Tropical Agricultural Biotechnology (ILTAB), which generated gene constructs for transformation and production of resistance to tomato leaf curl virus (TYLCV). Work continued at AGERI, using several different transformation strategies in order to develop tomatoes with resistance to TYLCV. However, the level of resistance obtained from these plants was found not to be stable and was affected by environmental conditions. Recently, AGERI scientists succeeded in transforming tomato with resistance to TCLV using a ‘suicide cell’ strategy, which offers an interesting alternative from the biosafety point of view. Field-testing was conducted and seeds from these plants are currently being collected for further testing.

4. Stem Borer Resistant Maize

The program initiated in 1991 with collaborating laboratories in three US universities (MSU, Cornell, Texas A&M), developed novel transformation techniques and produced two patents in this area. The production of insect resistant transgenic maize is one the most expensive research projects in ABSP, costing more than $1.5 million. In spite of these costs, in terms of overall results, this project ranks third, after the potato and cucurbit projects. Only two maize lines have being field tested in the US. During the initial phase, the project suffered from lack of coordination among participants, the use of non-commercial germplasm and unsuccessful Bt transformation protocols.

At the time the private sector (DeKalb, Pioneer Hi-Bred, Novartis, and Monsanto) was making important advancements leading to the commercialization of Bt corn. ABSP would have done well to initiate a collaborative effort with industry at that time - this team could not determine if this had been attempted. In 1994, under ABSP, Garst Seed Company (formerly ICI Seeds, Inc), USA, and the Central Research Institute for Food Crops (CRIFC), Indonesia, funded through USAID/Jakarta, started a program to develop Asian corn borer resistant tropical (Indonesian) maize germplasm. Although the project was valuable in terms of training and capacity building, and resulted in production of transgenic material, the project was not ultimately successful, due to policy and technical constraints related to the transformation of tropical maize varieties using proprietary technologies, lack of National Biosafety Guidelines in Indonesia, and because of personnel changes and lack of commitment from the company. To our knowledge, close to $600,000 were invested at ICI and no follow up process to negotiate valuable material has taken place to date. There was no information available to us on the status of the synthetic Bt gene and codon optimized Cry 1 A (b) and Cry V genes prepared by Dr. Ray Wu at Cornell (TAG report, October, 1994) and ICI seeds.

In 1996, a new research collaboration between Pioneer Hi-Bred and AGERI started a collaborative project for the introduction of Bt genes affecting corn borers endemic to the Middle East into Egyptian commercial corn varieties, including Bt genes from AGERI and Pioneer. Four novel constitute maize promoters were isolated, and patents were filed with one Egyptian researcher as a co-inventor. Pioneer Hi-Bred was encouraged to test some of their commercial Bt corn varieties in Egypt. Lessons to learn include a research agreement negotiated at the early phases of the planning process, and having the right institutions, particularly in terms of skills and personnel. We recommend producing a case study of this collaboration to document the excellent research results and protocols for collaboration developed among participants

In a separate collaborative effort with KARI (Kenya), research to determine factors governing resistance of Kenyan maize lines to stem borer insects was undertaken. According to the final report from KARI, results were valuable for selecting germplasm with different degrees of resistance.

Whatever the reason, it is unfortunate that ABSP did not establish more effective collaboration on maize transformation until late in Phase I. This case is an example of why the review team considers that some mechanism of public competition and peer review should be developed for assignment of research funds within large composite projects such as ABSP.

5. Bacillus thuringiensis Toxin Receptor

Research at University of Texas, Dallas investigates the molecular basis of insect resistance to the Bt toxins using Cry 3A toxin of B. thuringiensis subsp. tenebrionis. A major development was the characterization of a Bt receptor. Results also indicate that resistance to Bt toxin involves decreased toxin binding to the receptor, increased excretion of toxin and changes in the composition and activity of midgut proteolytic enzymes, and elevated amino peptidase activity. Recently, in collaboration with Pioneer Hi-Bred, proteomics of susceptible and resistant insects produced interesting results in terms of differential expression of proteins. Although this research is important, the immediate use of results is difficult to assess, particularly in view of recent publications on the identification of genes related to Bt resistance (Science, August 3, 2001). Moreover, this project used a different Bt toxin than the ones used in transgenic potato and maize project. In view of the importance of this kind of research for the private sector in particular, it could have been supported by other sources of funding. Instead, conducting food and environmental safety research related to Bt-cry V, necessary for distribution of the potato transgenic lines, would have reflected a better use of limited resources.

6. Drought and Salinity Tolerance

In this collaboration between AGERI and Ohio State University, transformation of immature embryos of Egyptian and American bread wheats with bacterial genes for salt and drought tolerance (obtained from Dr. Verma at Ohio State University) has started recently. AGERI has succeeded in transforming Egyptian wheat (Giza 163 and Giza 164) with salt-tolerance related genes (i.e., mtlD and fructan-accumulating, respectively) and achieved good expression for the first gene under stress conditions. The other gene is now being evaluated for efficiency in conferring salt tolerance to the Egyptian wheat cultivar Giza 164. A gene (dehydrin) identified and cloned by AGERI from a wild Egyptian germplasm (Vicia monantha) is providing interesting results. This project reflects the importance of developing national research capacities by participant countries in ABSP.

7. Development of Virus Resistance in Sweet Potato

The aim of this project is the development of transgenic sweet potato germplasm resistant to the Sweet Potato Feathery Mottle Virus (SPFMV), a constraint for production in Africa. The project was initiated by USAID, outside the framework of ABSP. USAID coordinated technology donation by Monsanto to KARI, providing for an important cutting edge experience in public-private sector arrangements for agbiotech transfer. The project also included the collaboration of ISAAA. ABSP’s role in the project consisted in providing assistance to KARI in their development of the biosafety proposal to the National Biosafety Committee, and by supporting training of Kenyan scientists. Informal advice in issues related to product development and testing was also provided by ABSP. Difficulties in regenerating and transforming plant material offered problems for the selection of varieties more accepted by farmers in Africa. Results from field trials using the African variety CPT-560 should be produced during 2001. It is difficult to assess the success of the project at this point.

8. High Beta-Carotene Mustard Oil

The goal of this collaborative project, between Monsanto Company (St. Louis, MO), the TATA Energy Research Institute (TERI) and ABSP/MSU, is to develop high beta-carotene mustard oil for use in India. These mustard varieties will provide a food-based approach to reducing Vitamin A deficiency in India. ABSP/MSU will provide management and fiscal oversight to this effort, with Monsanto providing technical oversight. The review team was not able to obtain information on the socio-economic or market analysis and market distribution aspects being assessed by the active partners, Monsanto and TERI.

9. Commercial Micropropagation of Tropical Crops

This private to private collaborative project had the goal of investigating the potential of embryo regeneration using bioreactors to increase production of pineapple, coffee, palms and banana. The collaborators were DNA Plant Technology, a plant biotechnology company in Oakland, California, and Agribiotecnología de Costa Rica (ACR) in Costa Rica, a micropropagation company. Although the project was disrupted by some ownership, location, and personnel changes at DNAP and a decrease in ABSP funding midstream, this private-to-private linkage had a number of positive outcomes, primarily because it supported co-learning rather than one-way technology transfer. Staff at ACR report that the work they have carried out with ABSP’s involvement has enhanced the reputation of their company.

Later, DNAP also entered into an agreement with Fitotek Unggul in Indonesia for the micropropagation of pineapple. In this case the request for participation came from Fitotek Unggul, a small Indonesian tissue culture company, because they were receiving large orders for pineapple plantlets from Indonesian plantations. DNAP cooperated to maximize the benefits of micropropagation methods using the bioreactor system with capacity of producing 12 million plantlets a year. However, when demand for pineapple plantlets suddenly and unexpectedly collapsed due to an export quality-control incident, the bioreactor system was no longer cost-effective for the Indonesian collaborator.

RESEARCH PROGRAM SHORTCOMINGS

The lack of adequate selection systems based on competitive calls for research proposals, and recommendations from peer review panels at both US and developing countries, led to difficulties in choosing the best research alternatives and implementing research activities that considered needs, research interests and target crops from developing countries.

Selection of research objectives in most cases involved simply taking technology off the shelf. This was in fact the initial design of ABSP, for reasons of expediency. This limitation led to a number of downstream complications such as IPR and biosafety. It may also make it more difficult for national decision makers and opinion leaders to develop and defend a sense of national ownership of the technologies. Research activities could have had a higher impact during the term of the project if a system based on matching necessities from partner countries with technologies available from advanced laboratories in the U.S. was more frequently implemented.

A valuable example of this approach within ABSP is the development of transgenic wheat with improved tolerance to environmental stresses, particularly drought, at AGERI, Egypt. The research effort results from an identified need for Egypt, makes use of high quality technology transfer from Ohio State University, and uses a gene (dehydrin), identified and cloned by AGERI scientists from a wild Egyptian germplasm (Vicia monantha). The lesson from this case reflects the benefits to be derived from ABSP’s earlier work to provide for research infrastructure and capacity building at research institutions in developing countries, capable of identifying their own needs, accessing the right technology, and performing independent research. Another valuable experience from ABSP is represented by the Inventory on Agricultural Biotechnology for Eastern and Central Africa Region, prepared for ASARECA, which identifies a research priority agenda for agbiotech programs, in accordance with needs and capacities from several countries in Africa.

The number of publications seems to be less than expected for a project of the size and complexity of ABSP. This calls attention to the fact that publications in peer review journals, did not included in most cases, scientists from both US and developing countries. Scientists from US research institutions generally published, independently of their collaborators in developing countries. The reverse situation was also observed, in the case of publications made by AGERI scientists in local journals. Difficulties to produce coordinated efforts from participants in the US and developing countries were also observed in some research activities This situation could be the consequence of the reduced number of meetings to discuss in detail scientific programs and planning experiments. These are of great necessity, in view of the complexity of the research activities performed by individual programs.

The project’s Technical Advisory Group (TAG) met only on few occasions, and the lack of evaluation of scientific results on a timely manner affected research output. Projects continued under soft evaluation procedures, and poor scientific accountability or enforcement measures, with no clear timeframes for product development. Continuation of basic research particularly in the last two years of the program led to good outputs in terms of biological research, but not as products within a framework of an integrated approach for agbiotech research. As an example, two of the transgenic products with higher possibilities to enter the market place lack IPR audits and freedom to operate procedures, as well as data related to environmental impact and food safety, both of importance for future product transfer and distribution to farmers. In view of limited resources, a better and more balanced investment could have been made by concentrating on products nearing commercialization, rather than continuing activities that are still far upstream.

A. RECOMMENDATIONS

· Discuss priorities with country collaborators to identify the best germplasm available for experimental and commercial purposes and the best trait that might have a better chance of being accepted (for instance, the question of marker genes is an important issue related with public acceptance).

· Analyze other requirements of the commercialization step taking into consideration the farming and distribution systems (see also “Technology Transfer and Commercialization”).

Section 3. POLICY

ABSP was designed almost 10 years ago to innovate in several aspects regarding the integration between science and policy development. The time was right for this integration to happen, as the project developed during the early stages of biotechnology applications in partner countries, that were (and still are) internalizing international agreements, writing national laws or providing other legal arrangements to regulate biosafety aspects of genetically modified organisms and intellectual property rights. ABSP, with assistance from consultants, helped countries build capacity for the implementation of activities to achieve its goals.

BIOSAFETY

It is clear that the development of risk analyses per se on a case by case basis depended on the stage of development of the new transgenic cultivars. The project did not manage to achieve many transgenic products with the exception of the Egyptian potato which seems closer to commercialization. However, it intelligently used the transfer of materials for laboratory research purposes and subsequent steps such as green house and small field tests to raise awareness regarding the importance and need of risk assessment among scientists and policy makers. Activities were concentrated on training, policy development and building basic infrastructure for greenhouse containment tests (Indonesia and Egypt).

Achievements

ABSP has established a sui generis approach towards policy development by introducing many young researchers and key scientists to organized biosafety courses, seminars and workshops, and by exposing others to bench training including in the private sector. By sponsoring scientists, who would become leaders at their institutions, to attend various biosafety events, ABSP helped to build a vital bridge between capacity building and policy development. Efforts started in 1993 when ABSP provided financial support for the participation of scientists from Kenya, Indonesia and Egypt to an eight-week biosafety internship program for assistance in developing guidelines. Subsequently, several workshops and internships helped participants build up sufficient awareness and knowledge, an effort that resulted in achievements such as the Indonesian biosafety guidelines (in use), Indonesian food safety guidelines (in use), Indonesian Biosafety Law (draft), Egyptian Biosafety Guidelines (in use), Kenyan Biosafety Guidelines (in use). As a means to having a wider impact, ABSP has lately taken a more regional approach in Africa forming a partnership with SARB (Southern Africa) and participating in the discussions with ASARECA (Eastern and Central Africa). It is noticeable that ABSP involvement in these two regional efforts in Africa is not as srong as in Egypt or Indonesia, primarily because African countries have only recently started to become interested in the transfer of transgenic technologies. An “inventory” of transgenic crops applicable to the Eastern and Central Africa region produced by ABSP at USAID’s (Africa Bureau) request is a very useful compilation of data and should be used as background information in the design of the region’s biotechnology program strategy. It should also serve as a model approach for other regions/countries when reviewing or designing biotechnology programs.

Shortcomings

Biosafety is a growing concern in developing countries which are under the continuous scrutiny of international non-governmental organizations such as Greenpeace, Friends of Earth and others, joined lately by Consumers International and its followers.

These concerns were evident a decade ago but grew rapidly stronger during Phase II, with the ultimate effect that ABSP underestimated the attention they would require when it began to assist countries in developing transgenic ag-products and associated regulatory policies. The issue of public awareness and acceptance has to be taken on board or products are not likely to get commercialized. Issues such as food labeling and identity preservation of crops are now being discussed and regulated in conjunction with the development of GMO risk assessment protocols.

ABSP has submitted biosafety applications to USAID biosafety committee for field testing potatoes in Egypt, Indonesia and South Africa, and has received permission to test in Egypt and South Africa. In addition, National Committees need to receive complete applications for their approval before commercialization can be achieved, given other constraints such as freedom to operate for proprietary genes and processes need to be negotiated. More emphasis needs to be given to assessing potential risks, and not just to the establishment of the agronomic acceptability of cultivars. For instance, the production of food safety data in Egypt will demand re-orientation of different laboratories and specific training for personnel not familiar with transgenics[1]. Such issues need to be considered earlier in the project, so as not to become constraints at the end. The Egyptian model can barely be taken as an example for other developing nations as much more funds were made available by the country mission to AGERI for the development of their biotechnology program. Capacity building was at its highest standards and even in this case, the conclusion was that “… depending on the stringency of the commercialization procedures, it will be difficult for a public-funded effort to meet the regulatory costs…”. An early prospective analyses of the country’s overall scenario should be a decisive step at the onset of a new project which is designed to be taken beyond field testing.

RECOMMENDATIONS

Considering that the capacity building and training aspects in biosafety were very successful, as they led to the development and implementation of important in-country policies and the installation of national biosafety committees, any follow-on project should:

· Analyze the national, regional and international related policy environment to identify procedures to be complied with, and include regulatory costs in the project budget. Develop cost estimates and provide sufficient funds for completion of major phases as biotechnology projects can reach prohibitive prices for developing countries when including food and environmental safety costs.

· Require a socio-economic analysis of the new technology including factors that will improve public acceptance (where needed).

· Give incentive to interactive networking across all ABSP projects, expose more participants to the availability of biosafety consultants (the same goes for the IPR section), and work to find ways they could benefit from interacting with them. Consultants should be asked to create a series of "case study" experiences that can enhance the immediate and long-term benefits to be received by the project.

INTELLECTUAL PROPERTY ISSUES

ABSP started in a period when developing countries had not been exposed to Trade Related Aspects of Intellectual Property Rights (TRIPS). However, since 1996, World Trade Organization (WTO) member countries have agreed to implement minimum intellectual property protection standards and therefore take on the exercise to review, modify or even create new legislation to protect biotechnology inventions and new cultivars[2]. Therefore, by the time ABSP strategies to build awareness and capacity in technology receiving countries was ongoing, each one was eager to acquire skills on intellectual property rights (IPR) related matters.

Achievements

ABSP has been very successful in organizing many quality courses, seminar and internships on the subject. The ABSP-initiated short courses on biosafety and IPR for U.S. and international participants, held in the United States and offered annually at MSU, have now been “spun-off” to MSU’s management and subsequently expanded to include sections on food safety and integrated pest management. These courses provide a rarely available introduction to key topics in a format accessible to research managers and policy makers. ABSP has directly sponsored participants from Costa Rica (1), Egypt (4), Kenya (2), Morocco (5), Indonesia (6), South Africa (1), India (2) and Ethiopia (1).

ABSP activities have also led to the development of PVP Law in Indonesia and Morocco, technology transfer and IPR offices in Indonesia (KIAT, linked to the Agency for Agricultural Research and Development) and in Egypt (OTTIP, linked to AGERI), and the establishment of a Plant Breeders’ Rights Office in Kenya. It is known that Indonesia will soon establish a PVP Office to implement the newly approved PVP Law, an activity under high demand by the private seed industry. Certainly, the training and awareness raised by ABSP integrated approach to research and policy development has given the private sector a better assurance allowing some companies such DNA Plant Technology, ICI Seeds (Syngenta), Pioneer Hi-Bred and Monsanto to agree on technology transfer projects. ABSP had the opportunity to use the MSU Office of Intellectual Property’s legal expertise when needed and has used Professor John Barton from Stanford University as a consultant to assist several countries in designing and implementing IPR legislation. An interesting feature of the program, uncommon in donor funded projects is the fact that ABSP has supported the filing of two patents during the development of research agreements.

Shortcomings

However well-prepared for the management of IPR issues due to its close links with MSU’s Intellectual Property Office, ABSP’s IP legal issues are still not well resolved. Except for donated genes (e.g. sweet potato technology donated to Kenya by Monsanto), other genes used, such as those for transformation of corn (ICI/Syngenta), tomato, potato, and cucurbit are without freedom to operate past the research stage. It is not clear that countries can use common promoters such as Monsanto’s 35S. Unfortunately even licensing agreements with US universities have not been resolved. In some cases, IPR considerations for US universities will differ from those applying in partner countries, due to the territoriality of patents. However, there may be reasons (such as future collaborations; or potential export products) why a project such as ABSP might chose not to take advantage of geographic differences in FTOs.

More recent projects (e.g., maize transformation with Pioneer Hi-Bred; stress-tolerant wheat at AGERI) have started to address FTO issues early in the research phase. However, all Material Transfer Agreements of projects closest to commercialization were designed and signed to cover research only, leaving any commercial applications for a later negotiation. As one of ABSP’s major goals was to reach commercialization of some transgenic products, this seems to have been a dangerous approach and in one case (ICI/Syngenta) has stopped the project pending further negotiations.

RECOMMENDATIONS

· No matter how difficult and time consuming all new biotechnology projects must have a freedom to operate feasibility study done first. A study of the required IP platform, licensing possibilities, required royalty return by different IP holders, market analysis and product acceptability must be developed either by the developing country’s officers or be a responsibility of the Funding Agency.

· Equally important is the issue of IP territoriality. Many processes and elements (promoters, markers, specific genes), patented in the U.S. and Europe, and used to produce transgenic organisms, may not have patents, either granted or filed, in developing countries. While researchers may be free to use the technology (for instance, a plant transformed in the US with the biolistic method may not be transferred to a developing country without due licensing however the same plant transformed in the country where the Gene-Gun patent was not filed can be used without any legal infringement of rights), this issue needs careful legal consideration, given its implications for eventual access to export markets, continued participation of private sector partners, and other issues.

· These studies can be contracted out or developed in conjunction with University IP Offices – a reason why it is important that any successor project to ABSP is assured that the coordinating University will provide such support (see also “Management”).

· As for the genes and other components already in use by the present ABSP project a strong recommendation by the external board that freedom to operate is urgently negotiated in every case remains to be implemented.

Section 4 TECHNOLOGY TRANSFER AND COMMERCIALIZATION

Technology transfer was a clearly stated aim of the ABSP Project from the outset, but the issue of commercialization was not mentioned until the October 1994 TAG report. As stated, the principal objective of the second phase of the project was "to improve the capacity and policy environment for the use, management and commercialization of agricultural biotechnology in developing countries and transition economies". In order to achieve that objective, the TAG proposed that emphasis be shifted away from research to the delivery of research products and that a commercialization specialist be included in the management team.

As interpreted in the first phase of the project, technology transfer was linked to issues and requirements which arose in biotechnology research collaboration -- particularly with private sector partners -- and, consequently, to the transfer of research skills, techniques and materials from US partners to the partner institutions in developing countries. However, technology transfer as exemplified in the objectives of the second phase of the project, and in the view of the evaluation team, implies a broader definition, encompassing the whole process of technological innovation from research to the "transfer" of a finished technology product -- for example, a virus-resistant cucurbit variety - to the farmer's field. In turn, that means either commercialization through the private sector or technology "delivery" through some non-market channel such as public extension services or NGOs.

The path to commercialization raises issues that require a more comprehensive approach. In the context of this evaluation, the key isssue would be the extent to which such an approach could -- or should -- have been accommodated within the ABSP project.

Achievements

During the life of the ABSP project to date, research collaboration, training courses and internships have been offered for developing country participants. Training of public sector scientists and/or regulators from several countries including Costa Rica, Egypt, Indonesia, Kenya have taken place at MSU, Cornell, or other institutions in the United States. In addition, individuals from the private or public sector in partner countries, have also benefited from research collaborations with private sector partners in the United States, as in the case of the Crops Research Institute in Indonesia and ICI Seeds in the development of Bt maize, and the AGERI and Pioneer collaboration on the development of transgenic maize. In-house training in private companies has been one of the innovative features of ABSP.

These activities have generally been highly appreciated by the developing country participants even though their impact may not have been immediate. For example, while research collaborations of Indonesian scientists on genetic engineering of corn, potato and sweet potato, which ended in 1995, have not yet resulted in the successful development of products, they have had useful "spin-offs" in enabling the scientists to use techniques acquired in subsequent research on other crops, including soybean and rice.

Enabling techniques and/or technologies which have been successfully transferred to participating countries include: the use of genetic markers for a number of crops; bioreactor micropropagation methods for pineapple (Indonesia); improved tissue culture techniques for banana (Kenya and Costa Rica); transgenic tomatoes, potatoes and sweet potatoes (Egypt, Kenya, Indonesia); and new transformation methods for cucurbit species (Egypt and Indonesia). In Costa Rica and Indonesia, techniques transferred have been the result of collaborations between local private companies and private companies in the United States.

An important aspect of these technology transfers has been the transfer of materials for research purposes, and subsequently, for greenhouse and field-testing. In Egypt, Indonesia, and Kenya these activities have helped stimulate awareness among scientists and policy-makers of requirements in the key biotechnology policy areas of IPRs and biosafety. At the same time, and at a more practical level, they have enhanced national capacity to draw up MTAs and work through the process involved in the transfer of genetic material from one country to another.

In the case of Indonesia, opportunities were also provided for the development of applied research considered to be of importance to Indonesian agriculture through a Small Grants Program funded by USAID/Jakarta. Projects on cocoa, ginger and citrus were conducted under this program.

Site visits to Egypt and Indonesia have highlighted the achievements of ABSP (referred to in the section on Research) in contributing to the advanced training of a critical mass of scientists who are now able to conduct research independently and who now have their own scientific networks in the United States and beyond. Indeed, the research capacity created at AGERI probably exceeds Egypt's current capacity to capitalize on it fully.

The program has also been successful in identifying inadequacies, and subsequently, supporting the development of the regulatory framework and institutions needed to ensure that biosafety and IPRs are not an impediment to technology transfer. These frameworks and institutions are now essentially in place in developing country partners, if not yet fully operational.

The ABSP project has also been instrumental in facilitating institutional innovation in the form of the Technology Transfer and Intellectual Property Office at AGERI in Egypt and, under the umbrella of the Agency for Agricultural Research and Development (AARD), the Technology Transfer Office (KIAT) in Indonesia. It is hoped that these institutions will play a key role in promoting collaboration between the public and private sectors in their respective countries and in facilitating the development and commercialization of new biotechnology products.

Shortcomings

Despite notable achievements, the evaluation points to shortcomings in the first two phases of the technology innovation cycle: research, product development and delivery. These include the "top-down" approach to collaborative research projects, where decisions were taken in the United States without prior consultation with developing country partners. They also suggest a research agenda which has been largely "science-driven", with little effort devoted to determining either needs (in a social sense), demand (in an economic sense) or priorities in partner countries.

New biotechnology products generated by ABSP are at varying stages in the second (or product development) phase of the innovation cycle, i.e. going through the necessary regulatory procedures prior to commercialization, in both Egypt and Indonesia. In Egypt, Bt potato and virus-resistant squash have been field-tested and are ready to be registered. However, as indicated in the Research Section, AGERI needs to address IPR, food safety and environmental safety issues before clear commercial rights for Bt transgenic potato developed in collaboration with MSU can be obtained. In Indonesia, Bt potatoes are awaiting authorization for field-testing and it is understood from our site visit that a new proposal will need to be submitted as an earlier proposal did not refer to the right varieties.

When it comes to preparing the way for the final, delivery phase of the innovation cycle - transfer to the farmer's field - the situation is difficult to evaluate. For reasons which are not clear - probably budgetary restrictions - no business or marketing expertise was added to the ABSP management team as specified in the 1991 RFA nor during the second phase of the project as proposed by the TAG.

However, since 1999, efforts have been undertaken by the Haas Business School of the University of California, Berkeley, to examine more closely the prospects for commercialization of products being developed at AGERI. The studies have concluded that AGERI has awarded high priority to developing a strong scientific culture, and successfully achieved this, but has neglected market-oriented research and has failed to establish links throughout the agro-food value chain. They have also concluded that links with industry are needed for the commercialization and distribution of the products currently being developed. Links with consumer groups are also needed to determine market trends and needs for future research and product development.

In Indonesia and South Africa, ex-ante socio-economic impact studies on the introduction of virus-resistant cucurbit varieties developed by Cornell through traditional breeding are being conducted. In Indonesia, where work is further advanced, the study highlights the extreme high growth potential of the vegetable seed market in Indonesia, confirmed during our interviews in Indonesia with East West Seed company and with the Research Institute for Vegetable Crops.

Preliminary findings on cucumber and melon suggest that there are considerable potential benefits to be gained for producers in terms of yield and reduced pesticide application from the lines provided by Cornell, although the harvesting of the new varieties would require more labor. For the potential to be realized, however, it would be necessary to incorporate stable virus-resistance in varieties more suitable for the Indonesian market, which would take some 5-7 years. Any socio-economic benefits to be anticipated will therefore not be realized in the short term.

Clearly, not all biotechnology research being conducted in the ABSP program is intended to lead to the development of an end product. It must also be acknowledged that it is not the mission of ABSP per se, to commercialize products generated by the project. However, in preparing the way to commercialization, if the advice of the TAG had been taken and business and/or marketing expertise included in the management team, some of the obvious shortcomings could have been corrected and changes in direction made during the course of the project. For example, the focus of research on cucurbits could have been redirected to local varieties of importance in the Indonesian market. Earlier analysis of market conditions and potential would have permitted sounder decisions regarding the crops and varieties most likely - or unlikely - to be commercialized in the short term and marketing strategies could have been drawn up accordingly.

In the case of AGERI, which has benefited from substantial investment both from the ABSP core budget and from the Cairo mission, the prospects for commercializing products generated could have been evaluated and, if necessary, facilitated at a much earlier stage.

Similarly, it would probably have been more profitable to conduct studies on market conditions and to gain insights into the obstacles likely to be encountered by ABSP's "near-market" technologies than to conduct socio-economic impact studies of products that are at an earlier stage of development. This kind of analysis would have highlighted the strengths and weaknesses of the seeds sector and the role of the public and private sector in the development and distribution of new technologies.

Under these conditions, ABSP could have been more effective, either directly or indirectly, by helping countries develop linkages, partnerships (both public and private sector) and expertise for accelerating the path to commercialization, i.e., move from testing to production. This could perhaps have been facilitated by drawing on independent expertise in partner countries and on expertise available within the Business School at MSU.

RECOMMENDATIONS

· ABSP needs to work with partner institutions, particularly AGERI, to formulate a clear plan for commercializing potatoes and cucurbits.

· ABSP should try to resolve issues surrounding the approval of multi-location trials for transgenic potatoes in Indonesia.

· Conduct relative socio-economic studies of the high beta-cartotene mustard project to determine development and delivery mechanisms.

Section 5. COMMUNICATION AND NETWORKING

ABSP has undertaken a number of communication, networking and information dissemiation activities. The original RFA for ABSP specified that ABSP continue and expand IPBNet, the International Plant Biotechnology Network. This was embodied in BioLink, ABSP's widely distributed newsletter designed in Phase I. BioLink was significant in that it was one of the first sources to reach public sector researchers in developing countries with the message that biosafety and IPR issues were essential considerations in their research. In Phase II, as part of the down sizing of the management office, BioLink was replaced by "Linkages", a simple project information newsletter with a more limited circulation to ABSP project participants. The ABSP website provides easy access to information on all facets of the ABSP program and, in particular, to practical information on a range of IPR issues, forms, etc. available from MSU. “Linkages” includes quarterly reporting as well as commentary from the ABSP Director on current events and travel.

During the course of the project, communication and networking activities have been considerably diversified; they extend beyond the earlier focus of the project and are more global in coverage.

Between May 1993 and March 2001, ABSP organised a total of 10 country-specific, regional or international meetings on different biotechnology-related themes. ABSP has also funded the participation of developing country representatives at regional or international meetings, financed membership to the US Bio-Industry Association, and subscriptions to CABI’s AgBiotechNet.

The extension of geographic coverage is exemplified by recent involvement in regional initiatives in Southern Africa. One example is the public awareness workshop supported by ABSP, which took place in Pretoria, South Africa, in May 2001, as part of the Southern Africa Regional Biosafety Program. This particular meeting was targeted at journalists, who, in addition to hearing oral presentations, were able to see GM crops in the field. This meeting was considered a success by the organisers in which 17 journalists were provided with objective background information on biotechnology and with contact details for obtaining additional information from regional scientists and/or regulators.

ABSP is also currently collaborating with UNDP and IBS/ISNAR in co-ordinating support to ASARECA, with ISNAR’s Biotechnology Service and with the BIO-EARN program on biosafety. The outgoing Director of ABSP is also a member of the Steering Committee of BIO-EARN.

Achievements

ABSP’s networking and outreach activities have impacted at different levels: at the level of the project itself, in developing country partners, and with the international biotechnology community at large.

The international visibility of ABSP per se has been enhanced by the participation of its Director and/or associates at international conferences on different aspects of agricultural biotechnology and at more specialised international gatherings on biosafety and IPRs.

Perhaps the most notable overall achievement of ABSP with respect to communication and networking is that it has raised awareness of a range of issues associated with agricultural biotechnology within the countries that have participated in the project and beyond. These issues include not only the potential of biotechnology to contribute to problems confronting developing country agriculture but also potential risks in its application and management. ABSP has consequently also heightened awareness of sensitive policy issues specific to biotechnology: IPR and biosafety.

Shortcomings and further needs

The unique experience that exists only as a result of the resources USAID invested in ABSP's pioneering collaborations is identifiably an ABSP output and remains to be made widely available. An ABSP publication should draw lessons from this experience, to be shared by others involved in international agricultural development efforts. Those lessons should be brought to bear in the design of any subsequent USAID funded biotechnology project and will be of mutual benefit to the U.S, where interest in strengthened public-private sector collaboration in agricultural research is increasing.

This could be done, for example, in a series of short briefing or issues papers reviewing and analysing some of the highlights and achievements, as well as some of the major obstacles or constraints encountered. Possible topics might include:

Ø Fostering biotechnology research collaboration between developed and developing country research institutes and avoiding the pitfalls;

Ø Brokering public/private, private/private or multiple public/private partnerships for biotechnology research and development;

Ø Plotting the path to commercialisation for ABSP biotechnology products.

Documentation of this kind, together with the Biosafety Workbook to be produced in the coming months, could serve as background material for a final international workshop (mentioned in the Work Plan for October 2000 to September 2001) to be organised by USAID. A final international workshop, the proceedings of which would be published, would help determine the directions of a new program and would, at the same time, be a fitting concluding event of ABSP.

At no stage during the life of the project have all partners been brought together to meet, exchange ideas, review progress and identify common constraints. This would have served the purpose of creating a sense of ownership and participation in the ABSP network that was found absent during field visits to the participating countries. Also, it would have highlighted, much earlier, the need to focus research on cucurbit and potato varieties of importance in the participating developing countries. In any future project, networking resources should be provided to bring all participants together on a regular basis to report on their work and discuss technical, logistical and policy-related issues of common interest. As suggested (see “Management”), an interconnected network has many advantages for both management and participants. Above all, it fosters a sense of shared responsibility toward a goal and helps sustain a project vision. The very unfortunate arson incident that destroyed ABSP offices at MSU, nevertheless, resulted in some positive outcomes, the Director was able to bring the program to the notice of the general public in the United States and also publicize it locally, particularly on campus. While there is no doubt that ABSP is well known and highly-respected internationally, it is possible that diversification into new topic and geographic areas has diverted attention from the need to consolidate the results and distil the lessons to be drawn from the life of this pioneering project.

Section 6. MANAGEMENT

ABSP was initially structured as a consortium of public sector institutions and private companies in the U.S. and developing countries, managed by Michigan State University. Over time, ABSP included as many as six other U.S. university partners, eight private sector partners, and six national agricultural research system (NARS) partners in developing countries. Management of a complex program such as ABSP was extremely challenging; particularly due to its broad thematic and geographic coverage and heterogeneity of partners; personnel changes in ABSP and its partners; shifts in emphasis between phases; budget cuts; and dramatic changes in the external perception of transgenic technologies which made its work progressively more difficult.

USAID’s 1991 RFA for ABSP stipulated a management directorship (MD). As implemented, this consisted of a Managing Director, who was also Innovation Director, and a Network Specialist. The MD was responsible for supporting a Technical Advisory Group (TAG) appointed by USAID “to monitor and evaluate the progress of the project". Phase I management also included a part-time Director for Research and Institutional Management (30/20%). An institutional advisory group (Internal Board of Directors) was composed of MSU Department Chairs, the Director of the MSU Institute of International Agriculture, representatives of Texas A&M and Cornell, and one representative per developing country having ABSP activities. This group was “to meet at an interim and final stages . . . to regularly monitor technical and managerial conduct of the project", review reports sent to USAID, provide oversight and guidance; and advise the research projects and ABSP management. Two positions stipulated by the 1991 RFA were not filled, possibly due to budget constraints: a Commercialization Specialist (not hired) and a Biosafety Specialist (supplied via a consultant contract).

In 1994, the TAG recommended a revised management structure for Phase II, which was to shift from research to application and delivery. During Phase II (from October 1997), management included a Director and an Associate Director. An External Board of Directors was appointed, envisioned as having a stronger role than the TAG. The Board was to meet annually to review work-plans and strategic direction of research and policy activities, review effectiveness of specific program elements, and provide recommendations to USAID and ABSP. Its members represent private biotechnology sector, U.S. regulatory agencies, development agencies, environmental groups, and the food industry. The MSU Internal Board of Directors continued, but with MSU membership only, and a new role--liaison between ABSP and the host organization, MSU.

Achievements

1. Balanced maintainence of research and policy development activities throughout the project: When ABSP began in 1991, activities consisted entirely of research projects. However, in 1993, ABSP held its first biosafety workshop and an internship in IPR, initiating what was to become an active program. As the project progressed and opportunistic external funding opportunities favored research (see section on “Budget and Buy-ins”), management balanced by investing proportionately more core funds and management staff time into policy-related activities. In Phase II, a "new generation" of policy support activities began, with a more regional focus, in North, Eastern, and Southern Africa. While ABSP's activities to maintain balance were largely successful, the cost in terms of management over-extension was high (see below).

2. Good working relations with the host institution and the USAID global program: Establishment of excellent working relations with the host institution in MSU and the USAID global program was an early and sustained accomplishment of program management. These good working relations were important in allowing ABSP to survive the drastic budget cut in the second year of the project, to be followed by further cuts and delays.

The MSU Office of Intellectual Property (OIP), founded the year after ABSP began, provided expertise needed by ABSP for developing contracts between private companies and developing country national programs that complied with Federal Regulations and also met company needs. The management strength is that ABSP obtained this support based on individual shared interests. The management weakness is that this critical expertise was not ensured through a formal link to an OIP office, or a person on staff with this expertise. As a result, IPR support to ABSP was reduced after the personnel change at the OIP office that occurred in Phase II, just when FTO issues were becoming “burning”.

Close links with other parts of MSU expertise -- economics and business, food laws, grades and standards -- of particular relevance to agricultural biotechnology in general, and to the ABSP project in particular, could have been established earlier. For example, this would have been particularly relevant to the commercialization of biotechnology products generated by AGERI.

Good communication with USAID in Washington enabled ABSP to link up with other USAID activities, such as support to ASARECA, to add value to existing investments.

3. Contacts with the private sector; expertise in managing public-private collaboration: ABSP management was able to establish contact with appropriate persons in the US private sector who were key to such successes as the AGERI-Pioneer internships, which resulted in useful scientific discoveries, and new professional contacts and professional perspectives for staff of both institutions. Although an early disappointment occurred in ABSP relationships with the private sector, in the ICI Seeds-CRIFC Indonesia maize project (see section on Research), thanks to the long-term nature of USAID support for ABSP, ABSP management was able to use this experience to achieve successes in subsequent cooperative agreements.

ABSP is currently assisting USAID, Monsanto, and a national institute in India, TERI, in making arrangements necessary to implement a new project which intends to increase nutritional value of mustard seed oil, a widely-used cooking oil in northern India. USAID’s contribution to the project is financed under its child survival mandate. The partners turned to ABSP when they needed experience in the details of managing international public-private cooperation and assistance in complying with USAID administrative requirements. This purely pragmatic development highlights the value of ABSP’s unique experience for allowing creative partnerships to happen (--and the importance of documenting ABSP’s experience before it dissipates).

4. Exploration of modes of involving national partners in planning project direction (Phase II): The successful joint planning workshop at AGERI in 1998, and the support to ASARECA through the inventory of biotechnologies corresponding to expressed ASARECA priorities, are examples of Phase II’s increasing exploration of ways to involve country partners directly in planning and responding to national priorities.

5. Achievement of international visibility for ABSP and its unique goals: International visibility was created initially through BioLink, the Phase I newsletter, and heightened throughout project duration through energetic participation in wide-ranging meetings at which ABSP speakers "spread the word". The several meetings and workshops organized by ABSP itself were effective means of making ABSP and its goals visible.

Shortcomings

1. Lack of capacity in business development: This aspect is discussed in both the management and technology transfer sections. Lack of business expertise resulted in an early failure to develop a culture and mechanism of effective "go/no-go" decisions about which research to continue. As a result, significant resources were spent on disappointing collaborations (see sections on Research and Technology Transfer and Commercialization).

Consequently, the decision not to hire the business development specialist mentioned in both the initial RFA and the Phase II proposal document, though no doubt carefully considered, was costly to project success. A future project should make it a priority to include business development expertise. If hiring a full-time expert is impractical or too costly, various means of access could be explored, such as "in kind" contributions from a private sector participant (if conflict of interest is not a factor), or financing long-term consultancies (similar to sabbaticals) for practicing professionals. Collaborative projects with the Business School at MSU could have provided interesting mutual benefit experiences at low cost.

2. Unclear roles and responsibilities for research management; lack of effective accountability mechanisms: Achieving clarity about roles and responsibilities was a challenge for ABSP from the first (see "Response to technical questions" from MSU to USAID, Sept 1991). A long-term multi-partner project, using new technologies and having expectations for product delivery, had a particular need for continuous review and accountability to ensure responsiveness as the project developed. However, over time, no consistently effective mechanism developed. Needs included:

· Frequent (at least annual) reviews of research progress and other issues related to ultimate project success.

· "Go/no-go" decisions regarding continuation of research that appeared unlikely to contribute to ABSP's overall goals.

· A sensitive mechanism for incremental adjustments in project plans, in response to internal or external developments.

· Consistent attention to projects running into delays, including analysis of reasons, and possible solutions or alternate plans.

In Phase I, the leader of an ABSP research project at MSU was designated ABSP Research and Institutional Management Director. The individual, who was also an Assistant Professor responsible for a tenure-track research program, most likely with teaching responsibilities, had taken the lead in developing the successful proposal for ABSP, proving initiative and energy. Yet the heavy work-load, the relatively junior status of the incumbent at the time of project initiation, and the conflict of interest (as a researcher funded by ABSP), were handicaps, and these project responsibilities were eventually rolled into the position of the full-time Managing Director.

The review team had no evidence that an ABSP director in fact reviewed overall ABSP research. Similarly, there is no record (perhaps due to the arson in ABSP offices during Phase II?) that the MSU Internal Board of Directors reviewed overall ABSP research, or what impact their reviews had. Available documents suggest that ABSP relied on the TAG to assess research progress, and that the TAG met only in 1993, 1994, and 1997. The external Board of Directors, which succeeded the TAG in Phase Two, is in composition, more of a management and implementation board than a scientific review board.

Project reports were compiled and provided to USAID on a quarterly, later semi-annual, basis. It is not clear how USAID used the reports -- they were lengthy and lacked summaries for quick grasp of progress, expectations, problems, and adjustments. The review team believes that staff shortages limited USAID's ability to digest and respond to the reports and may have forced USAID to rely on ABSP’s own mechanisms for research monitoring, despite problems with those mechanisms.

Some of factors that hampered ABSP's ability to require accountability stemmed from USAID circumstances (see also Section 7, Budget and Buy-Ins, below), including major budget cuts beyond USAID’s control. For example, according to the TAG report from its 1997 meeting, an attempt was made to institute “incentive-based funding to reward ... research ... which met timely milestones.” However, due to the yearly anemic funding cycle (which has averaged ... 20% to 35% budgetary reductions since year two) that initiative was terminated. During Phase II, it appears that a majority of the research conducted under ABSP was funded by USAID/Cairo. The mission’s criteria for project selection was different (more science-oriented, less product-oriented) than ABSP's, making it difficult for ABSP management to ensure that the overall research portfolio was appropriate to ABSP's goals (this was noted as early as 1997 TAG report).

3. Missed opportunities to develop a shared sense of responsibility to a common goal: A goal of all ABSP projects was to demonstrate benefits of biotechnology for sustainable agriculture in developing countries--through products created with, and in, the countries themselves. ABSP management would have been well-served by an inter-connected, multidisciplinary network in which all participants interacted, critiqued each other's work, and developed a sense of shared responsibility toward this common goal. Networking in ABSP is discussed in Section 6 on Communication and Networking; however, management aspects are mentioned here.

An interconnected network of ABSP projects would have created an atmosphere of positive peer pressure and constructive competition, motivating each project and member to excel in:

· Quality of research

· Rate of progress

· Staying on target

Since quality and motivation are always among management’s main challenges, a group that self-motivates its members is a support to management. For example, peer pressure from other ABSP projects might have helped motivate AGERI to recommend projects for USAID/Cairo support that were targeted to the goal of getting a product on the market. Interactive networks also generate spin-off projects with similar goals, often with diversified sources of funding. This empowers participants with confidence to proceed on their own paths at the end of a project -- a fundamental goal of development assistance.

Such an environment could have been achieved through regular meetings of all participants, from interns to directors. The cost could have been allayed by using the meetings as occasions for break out groups in which each multi-institutional project reviewed its work plans together. This would have been similar to the successful joint planning workshop at AGERI in 1998, but with the added benefit of immediate critical scrutiny by peers in other ABSP projects.

4. Over-extension of management staff in Phase II: The Phase II Directorship of two persons was responsible for a range of activities that had been covered by three to four persons in Phase I. TAG intended ABSP management in Phase II to focus on fewer projects, but this did not happen. Although the Indonesia buy-in ended, and with it, most of the activity in that country ABSP management took on new activities, mostly in Africa, in Phase II. The technology transfer component expanded (possibly to maintain balance with research activities, see section on Budget and Buy-ins), to include such things as several IPR and biosafety workshops; participation in meetings organized by various groups; and support to specific implementation-related activities such as Kenya’s field trials of transgenic sweet potatoes.

The new activities are important for their forward-looking nature, such as support to ASARECA decision-makers via a review of available technology relevant to ASARECA priorities, and the Southern Africa Regional Biosafety initiative. However, they left no time for management to cover other needs, such as seeking alternate ways to obtain business development expertise. USAID biotechnology project staff are equally overextended and therefore unable to use their time and attention to compensate for ABSP over-extension, even were that appropriate (see comments and recommendation under accountability mechanisms).

An additional consequence of management over-extension was the confusion that surrounded the final review, probably because so little time was available to prepare for it. The written Scope of Work for the review was highly detailed, yet the project information presented to the team was very general. Verbal instructions were to ignore the Scope of Work and provide a simple review on major achievements and shortcomings. However, later, much of the detailed content of the original Scope of Work was described as needed. In addition, instructions were received at some times that the review was only on ABSP’s achievements and shortcomings and recommendations for the close out phase, and at other times that recommendations for an eventual follow-up project were sought. The written Scope of Work should have included specific comments on how much detail is expected in the review, and the intended use of the final recommendations. Any changes in the level of detail and scope of the review should be documented in writing immediately, so that no time is lost to confusion and mis-directed effort.

A complex project such as ABSP should be documented for reviewers, and for other purposes, by a master table or simple uniform database. This table should list by title all ABSP research (sub) projects, their start and stop dates, the institutions and collaborators, objectives, and sources and amounts of funds spent per year or by phase. A similar summary should be kept for all short-term activities such as workshops, internships, and policy papers prepared. This information is essential for assessing the effectiveness of ABSP. Lack of compiled information resulted in many hours of addition “detective” work for the review team.

Information provided to a review team should correspond to the level of detail on which the team is expected to comment.

5. Challenges regarding country coordinators: The positive role of ABSP country national coordinators, particularly in Indonesia and Kenya, showed that this position can be a key to success. An in-country coordinator represents the project; maintains an overview of national activities; keeps the vision alive between major events such as meetings; and handles local opportunities or problems as they arise. A country coordinator with a modest budget for office equipment, travel, communications, and clerical support is able to be more effective than a coordinator who is asked to fulfill the function by stretching pre-existing (already scarce) resources. Recognizing these benefits, and the need to allow a modest cost, is in fact a strength of ABSP.

As with management at the lead institution, there is a need for clear definition of communication lines, roles and responsibilities for country coordinators. For a country with more than one ABSP project, an independent coordinator would function better than a member of one of the funded institutions.

There is a need to consider how conflict of interest will be avoided. For example, in Egypt, the in-country coordinator is director of the main ABSP partner research institute. The same institute is the Secretariat of the National Biosafety Committee, responsible for biosafety reviews of products of other institutes or companies.

RECOMMENDATIONS

· Any future project should assign research monitoring and directing duties to a research director having time, authority and effective mechanisms to require accountability. More frequent monitoring and decision-making steps would better serve any future project, particularly a project oriented toward eventual product commercialization (see also “Research”).

· Responsibility for designing the monitoring system should be joint between both the lead institution and USAID, in order to take into account circumstances of both which will affect the project’s ability to require accountability.

· External Advisory Boards should meet at least annually and consist of sufficient experts in research, management, implementation, so as not to overload any individual to the point of reducing quality of input.

· Information should be obtained when results funded by ABSP are the basis of work that continues after association with ABSP has ended. For example, a project might continue to develop varieties using material developed with ABSP funding. This information is needed to assess long-term impact.

· Given the many responsibilities of the USAID Biotechnology Officer, above and beyond liaison with ABSP, there is a clear need for additional staff support for this USAID position. USAID has relied on a career-entry fellowship position as support for the Biotechnology Officer. Additional well-qualified and experienced support has been needed for the past ten years, and is urgent now, as the responsibilities placed on the Biotechnology Officer are increasing rapidly.

Section 7. BUDGET AND BUY-INS

BUDGET

The major cuts in USAID's overall budget for agricultural development that occurred during the 1990s was a severe blow to many activities (including the CGIAR, the system of international research centers with whom ABSP originally intended to partner, see Response to Technical Comments, Sept. 1991). ABSP did not escape: its core budget was drastically cut in the second year, just at the time that activities were scheduled to expand. Given the magnitude of this initial cut ($800,000, the equivalent to 80% of an anticipated single-year budget, or about 13% of the total budget anticipated by the RFA for the first six-year project), and subsequent cuts ("averaged ... 20% to 35% budgetary reductions since year two"-TAG 1997 report), it is most remarkable that ABSP was able to accomplish as much as it did, relative to the original goals.

Altogether, the total loss over ABSP's duration was roughly equivalent to about a two-years' worth of resources cut from the original six-year project. In addition, funding was frequently late in arriving, and subsequent resulted in further work delays in the project. ABSP management clearly expended enormous personal energy, persistence, and persuasion to have been able to attract and retain capable partner institutions, especially in the private sector, in such a situation of financial retrenchment and unpredictability.

The review team concurs with the TAG report of 1997, that USAID seek ways to better protect core budgets for its projects, particularly once commitments have been made and collaborators have begun their expenditures. This is necessary to ensure that the best possible partners will remain interested in collaborating with USAID, and to ensure returns on public investment. Models might be sought in other federal grant programs that have authority to award funds for multi-year projects.

BUY-INS

1. An anticipated resource which funded diverse efforts: A significant degree of opportunism was built into ABSP from the start, with the expectation that country mission "buy-ins" would be sought, to support additional research or policy development objectives (see RFA, 1991). It was also anticipated in the RFA that each country mission participating via a buy-in would have objectives appropriate to its local situation, and therefore possibly different from the objectives of existing ABSP activities.

In general, the program has benefited from the additional funds contributed by the USAID missions in the different countries. For example, in both Egypt (Pioneer) and Indonesia (Fitotek and ICI), buy-ins made possible (Pioneer, ICI), or enhanced (DNAP/Fitotek) the development of private sector collaboration.

These buy ins were generally for research ($8.6 million) but at least $1 million was obtained for policy development activities (Morocco) and/or planning activities (Africa Bureau). When buy-in funding in Phase II, in particular, strongly emphasized research, ABSP management compensated by organizing and conducting ten new policy-development activities (workshops or internships), equivalent to two per year. ABSP management's achievement in maintaining a balance between research and policy development again shows an enormous investment of personal energy and persistence.

2. Divergence between goals of USAID country missions and the global program: The RFA did not, however, foresee a situation in which the country-based objectives of a "buy-in" partner would lead to funding of research under the ABSP umbrella that yet diverged from the underlying goal of product delivery within the ABSP time frame. This occurred in the case of research intended to support the work at AGERI. The USAID/Cairo mission, in addition to their support of product-oriented projects such as tomato research at ILTAB/SCRIPPS, potato transformation at MSU, and cucurbit transformation and pathology/breeding at MSU and Cornell, also supported basic science that was high quality but could not be expected to yield a product within the ABSP time frame. This was particularly the case in Phase II with research at Ohio State University and the University of Texas/Dallas. In addition, USAID/Cairo's supplementary support of two ABSP core-funded projects (potato and cucurbit transformation) was significantly greater in Phase II than ABSP core support. The financial contribution was welcome, however, it put ABSP management in a difficult situation. Management's ability to require accountability for technical progress and adherence to ABSP's goals of product development was undermined. Moreover, the Cairo mission does not have technical capacity to review biotechnology research. Although the potato project appears to have stayed largely on track, the cucurbit project showed slow technical progress at MSU, and poor coordination between all institutional partners (within the U.S. and between the U.S. and Egypt), yet was insulated from accountability to ABSP management.

This review team recognizes that USAID has decentralized its decision-making structure in order to allow the country missions to act on their better knowledge of each local situation. However, for best use of taxpayers' money in the service of sustainable development, there needs to be more serious effort at coordination, to harmonize the country mission's knowledge of local needs and opportunities, with the overall goals of global programs selected for buy-in. Projects that demonstrate exceptional synergy between country/mission objectives and global goals should be recognized.

In this, the present review team concurs with the recommendation of the TAG in 1997 (see the TAG's report of its 1997 meeting, section VI. Management. 1. "Dr. Ives has inherited a difficult situation with regard to the large budget buy-ins from Egypt and Indonesia. Because those programs are largely supported from country mission funds, they operate somewhat independently of ABSP management. Recommendation: Reporting guidelines, work-plan development and authorization, and budgetary controls for country-buy in programs should be parallel to those of programs supported by the core budget of ABSP".

(The TAG, in its 1998 report, considered a danger that core funds would be reduced commensurate to the amount of buy-in funds. This would have been inconsistent with the 1991 RFA, which contemplated buy-ins as additional rather than substitutionary. This review team agrees; however, there is no evidence available to this team that cuts occurred in response to significant buy-ins).

3. USAID funding and sustainability of AGERI: The review team was unable to determine with confidence the proportion of AGERI’s operating budget that is received from USAID sources, however, it is certainly substantial. USAID currently anticipates reducing its involvement in Egypt in general and therefore, in supporting AGERI, although AGERI management is sanguine that USAID support will continue.

For several reasons, the review team would like to see AGERI continue, achieve success with marketed biotech products, and become sustainable.

· AGERI has achieved technical excellence; it is capable of conducting biotechnology research largely independent of external technical advice -- this is a major accomplishment for U.S. (and Egyptian) investment.

· AGERI’s labs and scientists, and the understanding of biosafety issues that it has been able to share, are resources for Egypt and the region.

· AGERI has symbolic importance for the developing world:

Ø If AGERI succeeds, it will be a clear case that developing countries can achieve their own biotech capacity, for their own benefit.

Ø If AGERI fails, the effect will be to strengthen--at least for a time--the voices of pessimism that try to reinforce that biotech can only be a technology imposed by and for economically powerful countries.

RECOMMENDATIONS

· To assist in maintaining coherence of projects and obtaining maximum benefits from its investments, USAID should develop agency-wide guidelines for best practice for interactions between global units and country missions within USAID. These guidelines should include mechanisms for setting priorities and objectives and for resolving conflicts of interest. They should also cover work plan development and approval, reporting requirements, model project contracts with guidance for IP negotiations, biosafety issues, or other relevant regulatory or safety concerns, and project evaluation criteria.

· The review team notes the precedent set when USAID closed its aid to research in Costa Rica. The team recommends that USAID identify close out funds to be used for establishing a foundation for long-term competitive funding of biotechnology research and policy initiatives and needs in Egypt. This would be similar to the CR-USA foundation established in Costa Rica. AGERI is well qualified to compete for a significant proportion of the grants that such a foundation would award, and this would therefore be a mechanism for support to sustainability of AGERI. At the same time, a foundation would create a new mechanism to give opportunities for excellence in other Egyptian institutions such as the universities. As the process of establishing a foundation takes time, USAID should begin the planning process now.

Section 8. REFERENCES CITED

Covenent, B. 2000. The Role of the Private Sector in Providing Biotechnology Access to the Poor. In: M. Qaim, A.F. Krattiger and J. von Braun, eds. Agricultural Biotechnology in Developing Countries: Towards Optimizing the Benefits for the Poor, Kluwer Academic Publishers, Dordrecht, The Netherlands

Frey, K. J. 2000. National Plant Breeding Study-IV. Future priorities for plant breeding. Iowa State University/ Iowa Agriculture and Home Economics Experiment Station; USDA/CSREES and ERS cooperating.

National Research Council (NRC) Board on Science and Technology for Development. 1990.

Plant Biotechnology Research for Developing Countries. National Academy Press, Washington, D.C. 44p.

Interagency Working Group (IWG) on Plant Genomes, National Science and Technology Council, Committee on Science. Nov. 2000. Progress report, National Plant Genome Initiative. Executive Office of the President of the United States, Washington, D.C. Available at www.reeusda.gov/nri/pubs/pubs.htm

Stockstad, E. 2001. First light on genetic roots of Bt resistance. Science, 293, 778

Section 9. LIST OF ACRONYMS

AARD: Agency for Agricultural Research and Development

ABSP: Agricultural Biotechnology Support Project

ACR: Agribiotechnologia de Costa Rica

AGERI: Agriculture Genetic Research Institute

ASARECA: Association for strengthening agricultural research in Eastern and Central Africa

BIO-EARN: East African Regional Programme and Research Network for Biotechnology, Biosafety and Biotechnology Policy Development

CRIFC: Central Research Institute for Food Crops

DNAP: DNA Plant Technologies

FTO: Freedom to Operate

ILTAB: International Laboratory for Tropical Agricultural Biology

IP: Intellectual Property

IPR: Intellectual Property Rights

ISAAA: International Service for the Acquisition of Agri-biotech Applications

ISNAR: International Service for National Agricultural Research

KARI: Kenya Agriculture Research Institute

KIAT: Technology Transfer Office, Indonesia

LDC: Least developed country

MD: Management Director

MSU: Michigan State University

MTA: Material Transfer Agreement

NARS: National Agricultural Research Systems

NGO: Non Governmental Organization

NRC: National Research Council

NSTC: National Science and Technology Council

OIP: Office of Intellectual Property

OSU: Ohio State University

OTTIP: Office of Technology Transfer and Intellectual Property, Egypt

PVP: Plant Variety Protection

RFA: Request for Application

SARB: Southern Africa Regional Biosafety

TAG: Technical Advisory Group

TCCP: Tissue Culture for Crops

TERI: Tata Energy Research Institute

TRIPS: Trade Related Aspects of Intellectual Property Rights

UPOV: International Union for the Protection of New Varieties

USAID: U.S. Agency for International Development

USDA: US Department of Agriculture

WTO: World Trade Organization

APPENDIX B - BIOTECHNOLOGY AND BIODIVERSITY INTERFACE (BBI) COMPETITIVE GRANTS PROGRAM

Competitive Grants Program on Biotechnology and Biodiversity Interface (BBI)

Request For Application, Fiscal Year 2001

I. Background and Program Description

USAID has gained significant experience in the area of agricultural biotechnology through support of collaborative research and technical assistance programs over more than ten years. Past programs include scientific training, research and technology development, biosafety regulatory development and training, building institutional management capacity in intellectual property rights and technology transfer, and promoting collaboration with the private sector. As part of USAID’s efforts to scale up activities and address a broader agenda in agricultural biotechnology a new competitive grants program in biosafety is being initiated this fiscal year.

Agricultural crops improved through genetic engineering offer important benefits including the potential of enhanced agronomic, nutritional, and marketing qualities. Similarly, genetically engineered livestock vaccines can improve disease control and surveillance, improve productivity and marketability of dairy and animal products and thus economic growth. Genetically engineered biotechnology applications, however, also raise safety concerns, particularly concerns about their impact on health and biodiversity. Data generated to evaluate and regulate concerns about the food safety of genetically engineered products are generally applicable across countries and thus developing countries will be able to assess risks in this area drawing from regulatory studies conducted in the U.S., Europe, or elsewhere. The interactions between agriculture and its surrounding environment, however, differ from country to country due to different crop systems and differences in biodiversity; thus the interactions between the two will not be directly applicable in all countries. Environmental risks must therefore be assessed on a case-by-case basis.

The Biotechnology and Biodiversity Interface (BBI) competitive grants program is a five year program in biosafety research aimed at addressing the interface between the use of agricultural biotechnology, particularly genetically engineered crops, and natural biodiversity as it occurs in developing countries that are rich in biodiversity.

II. Purpose of the Program

This program will support research that provides information needed to assess the potential risks to natural biodiversity associated with agricultural biotechnology and to design risk management strategies appropriate to developing country agricultural systems.

The primary goals of this program are:

· To assist regulatory bodies in making science-based decisions about the effects on biodiversity of introducing genetically engineered organisms into the environment.

· To begin generating scientific data on potential risks associated with particular applications of biotechnology on specific aspects of biodiversity in developing countries.

· Develop strategies for managing potential risks in the context of agroecosystems found in developing countries.

· Build collaboration between agricultural research and environmental conservation communities in the U.S. and developing countries.

· To build capacity among developing countries in risk assessment and risk management research.

III. Available Funding

It is estimated that $1.8 million will be available in Fiscal Year 2001 to fully fund four to six grants. New rounds of awards in future years are subject to availability of additional funding.

IV. Areas of Research to be Supported

Proposals are sought that conduct research on risk assessment and risk management associated with the usage of agricultural biotechnology products in developing countries. In particular, proposals should address research on the quantification of specific risks, determination of the consequence of identified risks, and strategies for managing such risks in one or more of the following areas:

· Gene flow: The movement of transgenes (e.g. genes engineering into a plant) from genetically engineered products to wild species through out-crossing or DNA uptake, consequence of gene flow on related wild species in terms of changes to the balance or function of that species in the environment. This is of particular concern in the developing world which contains the centers of origins (and thus many wild related species) of the major food crops.

· Ecological fitness of GE crops: The effect of genetically engineered traits on the ability of crops to survive or compete in wild ecosystems or become weeds.

· Impact on non-target species: Effect of engineered traits on harmless or beneficial organisms such as plants, insects, birds, herbivores, or soil microbes.

· Pest resistance management: Development of crop management, trait expression, and integrated pest management strategies for the use of GE crops in developing country farming systems to help deter or postpone development of pest resistance. Some systems are being developed for U.S. agricultural systems but these will likely need adaptation and monitoring to address differences in developing country agricultural systems.

· Compatibility with other agricultural practices: Integration with or potential impact on the efficacy of other biocontrol, integrated soil, or nutrient management practices.

· Other risk management strategies: for example to address gene flow through planting borders which buffer crops from the surrounding environment.

· Monitoring: collection of data from the environment around field tests and commercial-scale production systems to monitor potential impacts such as gene flow, pest resistance, or harm to non-target species.

V. Criteria for Application

A. Who Can Apply

Proposals are open to all eligible applicants. Eligible applicants may be from U.S. universities and research institutions, International Agricultural Research Centers (IARCs), international environmental conservation groups, private sector seed and biotech companies, developing country agriculture or environmental research institutions, and developing country regulatory bodies. In addition, collaborations between U.S. or international research institutions and developing country research or regulatory institutions, and collaborations between agriculture and environment communities are encouraged.

B. Requirements for Application

Applicants must use the following guidelines for preparing grant applications:

· Proposed research must address the effects on biodiversity of transgenic or genetically engineered organisms such as crops, animal vaccines, microbes etc.

· Proposed research may include either plant or animal biotechnology products that have agricultural applications.

· Proposed research may take place in one country or be a regional activity. Research activities can take place in all countries where there is no legal provision against USAID assistance.

· Proposed research must address the interface between agricultural biotechnology and natural biodiversity.

· Proposed research must further the regulatory decision making process.

VI. Proposal Format

The proposal should be no longer than 10 pages (either single or double spaced), including title page, but excluding the CVs. It should be in the following format.

A. Title Page containing the following:

1. Title
2. Submitting institution
3. Investigators: Name, title, address, contact information (including email and fax), signatures of lead investigator(s)
4. Institutional Administrative Officials (if different from investigator): Name, title, full mailing address, signatures
5. Budget: Total requested funding
6. Duration: Number of years of project funding
7. Collaborating countries: All countries involved in the project

B. Technical Summary/Abstract (should be one paragraph in length)

C. Aim and Specific Objectives

1. Background and Rationale
2. Experimental Design
3. Expected outcomes and research impact
4. Time Line
5. Role of each institution in collaboration

D. Facilities and Resources

E. Proposed budget

F. References

G. Curriculum Vitae of principal researcher/s

VII. Submission of Proposals

A. When and Where to Submit

An original and six copies of a proposal must be submitted. Proposals should be typed, single or double spaced, on one side of the page only. The text of the proposal should be prepared using type no smaller that 12 point font size and one-inch margins. All copies should be sent to the following address:

Grants Program on Biotechnology and Biodiversity Interface

U.S. Agency for International Development

G/EGAD/AFS/AEMD

Washington, D.C. 20523-2110.

Proposals submitted via facsimile (fax) or e-mail will not be accepted.

PROPOSALS MUST BE RECEIVED AT USAID BY AUGUST 10, 2001.

B. Acknowledgment of Proposal Receipt

The receipt of all proposals will be acknowledged via the Internet (e-mail) or fax. Therefore, it is important to include the e-mail address and/or fax number of the principal contact on the title page. This acknowledgement will contain a proposal identification number. Once your proposal has been assigned a proposal number, please cite that number in future correspondence.

IX. Proposal Evaluation

A. Evaluation Criteria

Proposals will be evaluated and ranked according to the following criteria:

1) POTENTIAL APPLICATION OF PROPOSED RESEARCH TO THE REGULATORY PROCESS (40 POINTS)

· Degree to which proposed research specifically addresses priority regulatory questions.

· Degree to which the technologies studied are likely to be applied in the near term.

· Degree to which research builds capacity building among regulatory systems to undertake science-based risk assessment.

2) TECHNICAL FEASABILITY (40 POINTS)

· Elaboration of research design.

· Experience level and demonstrable ability of researchers to carry out the proposed research.

· Available resources.

3) DEGREE OF COLLABORATION (20 POINTS)

· Collaboration between U.S. or international research institutions and developing country research or regulatory institutions.

· Collaboration between agriculture and environment communities.

B. Evaluation Committee

Proposals will be evaluated by a committee that consists of experts in agricultural and environmental issues surrounding the use of genetically engineered organisms and/or ecosystem/biodiversity management. These experts will be drawn from U.S. government agencies such as USAID, USDA, EPA and State Department, and U.S. universities and non-governmental organizations (NGOs).

C. Awards

Selection of awards will be made by August 31, 2001.

In accordance with a Federal Regulation 22 CFR 216, all grants will be required to submit to an environmental review. In addition, under the new USAID biosafety policy all grants which involve the field testing or use of genetically engineered products will be required to submit a biosafety proposal to USAID for external review and demonstrate host country biosafety approval for the specific experiment or use proposed. This external biosafety review will be incorporated into an environmental review.

APPENDIX C –CERTIFICATIONS

U.S. Agency for International Development

CERTIFICATIONS, ASSURANCES, AND OTHER STATEMENTS OF RECIPIENT[3] [4]

PART I - CERTIFICATIONS AND ASSURANCES

1. ASSURANCE OF COMPLIANCE WITH LAWS AND REGULATIONS GOVERNING NON‑DISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS

(a) The recipient hereby assures that no person in the United States shall, on the bases set forth below, be excluded from participation in, be denied the benefits of, or be otherwise subjected to discrimination under, any program or activity receiving financial assistance from USAID, and that with respect to the grant for which application is being made, it will comply with the requirements of:

(1) Title VI of the Civil Rights Act of 1964 (Pub. L. 88‑352, 42 U.S.C. 2000‑d), which prohibits discrimination on the basis of race, color or national origin, in programs and activities receiving Federal financial assistance;

(2) Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794), which prohibits discrimination on the basis of handicap in programs and activities receiving Federal financial assistance;

(3) The Age Discrimination Act of 1975, as amended (Pub. L. 95‑478), which prohibits discrimination based on age in the delivery of services and benefits supported with Federal funds;

(4) Title IX of the Education Amendments of 1972 (20 U.S.C. 1681, et seq.), which prohibits discrimination on the basis of sex in education programs and activities receiving Federal financial assistance (whether or not the programs or activities are offered or sponsored by an educational institution); and

(5) USAID regulations implementing the above nondiscrimination laws, set forth in Chapter II of Title 22 of the Code of Federal Regulations.

(b) If the recipient is an institution of higher education, the Assurances given herein extend to admission practices and to all other practices relating to the treatment of students or clients of the institution, or relating to the opportunity to participate in the provision of services or other benefits to such individuals, and shall be applicable to the entire institution unless the recipient establishes to the satisfaction of the USAID Administrator that the institution's practices in designated parts or programs of the institution will in no way affect its practices in the program of the institution for which financial assistance is sought, or the beneficiaries of, or participants in, such programs.

(c) This assurance is given in consideration of and for the purpose of obtaining any and all Federal grants, loans, contracts, property, discounts, or other Federal financial assistance extended after the date hereof to the recipient by the Agency, including installment payments after such date on account of applications for Federal financial assistance which were approved before such date. The recipient recognizes and agrees that such Federal financial assistance will be extended in reliance on the representations and agreements made in this Assurance, and that the United States shall have the right to seek judicial enforcement of this Assurance. This Assurance is binding on the recipient, its successors, transferees, and assignees, and the person or persons whose signatures appear below are authorized to sign this Assurance on behalf of the recipient.

2. CERTIFICATION REGARDING DRUG‑FREE WORKPLACE REQUIREMENTS

(a) Instructions for Certification

(1) By signing and/or submitting this application or grant, the recipient is providing the certification set out below.

(2) The certification set out below is a material representation of fact upon which reliance was placed when the agency determined to award the grant. If it is later determined that the recipient knowingly rendered a false certification, or otherwise violates the requirements of the Drug‑Free Workplace Act, the agency, in addition to any other remedies available to the Federal Government, may take action authorized under the Drug‑Free Workplace Act.

(3) For recipients other than individuals, Alternate I applies.

(4) For recipients who are individuals, Alternate II applies.

(b) Certification Regarding Drug‑Free Workplace Requirements

Alternate I

(1) The recipient certifies that it will provide a drug‑free workplace by:

(A) Publishing a statement notifying employees that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the applicant's/grantee's workplace and specifying the actions that will be taken against employees for violation of such prohibition;

(B) Establishing a drug‑free awareness program to inform employees about‑‑

1. The dangers of drug abuse in the workplace;

2. The recipient's policy of maintaining a drug‑free workplace;

3. Any available drug counseling, rehabilitation, and employee assistance programs; and

4. The penalties that may be imposed upon employees for drug abuse violations occurring in the workplace;

(C) Making it a requirement that each employee to be engaged in the performance of the grant be given a copy of the statement required by paragraph (b)(1)(A);

(D) Notifying the employee in the statement required by paragraph (b)(1)(A) that, as a condition of employment under the grant, the employee will‑‑

1. Abide by the terms of the statement; and

2. Notify the employer of any criminal drug statute conviction for a violation occurring in the workplace no later than five days after such conviction;

(E) Notifying the agency within ten days after receiving notice under subparagraph (b)(1)(D)1. from an employee or otherwise receiving actual notice of such conviction;

(F) Taking one of the following actions, within 30 days of receiving notice under subparagraph (b)(1)(D)2., with respect to any employee who is so convicted‑‑

1. Taking appropriate personnel action against such an employee, up to and including termination; or

2. Requiring such employee to participate satisfactorily in a drug abuse assistance or rehabilitation program approved for such purposes by a Federal, State, or local health, law enforcement, or other appropriate agency;

(G) Making a good faith effort to continue to maintain a drug‑free workplace through implementation of paragraphs (b)(1)(A), (b)(1)(B), (b)(1)(C), (b)(1)(D), (b)(1)(E) and (b)(1)(F).

(2) The recipient shall insert in the space provided below the site(s) for the performance of work done in connection with the specific grant:

Place of Performance (Street address, city, county, state, zip code)

Alternate II

The recipient certifies that, as a condition of the grant, he or she will not engage in the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance in conducting any activity with the grant.

3. CERTIFICATION REGARDING DEBARMENT, SUSPENSION, AND OTHER RESPONSIBILITY MATTERS ‑‑ PRIMARY COVERED TRANSACTIONS[5]

(a) Instructions for Certification

1. By signing and submitting this proposal, the prospective primary participant is providing the certification set out below.

2. The inability of a person to provide the certification required below will not necessarily result in denial of participation in this covered transaction. The prospective participant shall submit an explanation of why it cannot provide the certification set out below. The certification or explanation will be considered in connection with the department or agency's determination whether to enter into this transaction. However, failure of the prospective primary participant to furnish a certification or an explanation shall disqualify such person from participation in this transaction.

3. The certification in this clause is a material representation of fact upon which reliance was placed when the department or agency determined to enter into this transaction. If it is later determined that the prospective primary participant knowingly rendered an erroneous certification, in addition to other remedies available to the Federal Government, the department or agency may terminate this transaction for cause or default.

4. The prospective primary participant shall provide immediate written notice to the department or agency to whom this proposal is submitted if at any time the prospective primary participant learns that its certification was erroneous when submitted or has become erroneous by reason of changed circumstances.

5. The terms "covered transaction," "debarred," "suspended," "ineligible," lower tier covered transaction," "participant," "person," "primary covered transaction," "principal," "proposal," and "voluntarily excluded," as used in this clause, have the meaning set out in the Definitions and Coverage sections of the rules implementing Executive Order 12549.[6] You may contact the department or agency to which this proposal is being submitted for assistance in obtaining a copy of those regulations.

6. The prospective primary participant agrees by submitting this proposal that, should the proposed covered transaction be entered into, it shall not knowingly enter into any lower tier covered transaction with a person who is debarred, suspended, declared ineligible, or voluntarily excluded from participation in this covered transaction, unless authorized by the department or agency entering into this transaction.

7. The prospective primary participant further agrees by submitting this proposal that it will include the clause titled "Certification Regarding Debarment, Suspension, Ineligibility and Voluntary Exclusion‑‑Lower Tier Covered Transaction,"[7] provided by the department or agency entering into this covered transaction, without modification, in all lower tier covered transactions and in all solicitations for lower tier covered transactions.

8. A participant in a covered transaction may rely upon a certification of a prospective participant in a lower tier covered transaction that it is not debarred, suspended, ineligible, or voluntarily excluded from the covered transaction, unless it knows that the certification is erroneous. A participant may decide the methods and frequency by which it determines the eligibility of its principals. Each participant may, but is not required to, check the Nonprocurement List.

9. Nothing contained in the foregoing shall be construed to require establishment of a system of records in order to render in good faith the certification required by this clause. The knowledge and information of a participant is not required to exceed that which is normally possessed by a prudent person in the ordinary course of business dealing.

10. Except for transactions authorized under paragraph 6 of these instructions, if a participant in a covered transaction knowingly enters into a lower tier covered transaction with a person who is suspended, debarred, ineligible, or voluntarily excluded from participation in this transaction, in addition to other remedies available to the Federal Government, the department or agency may terminate this transaction for cause or default.

(b) Certification Regarding Debarment, Suspension, and Other Responsibility Matters‑‑Primary Covered Transactions

(1) The prospective primary participant certifies to the best of its knowledge and belief, the it and its principals:

(A) Are not presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from covered transactions by any Federal department or agency;

(B) Have not within a three‑year period preceding this proposal been convicted of or had a civil judgment rendered against them for commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a public (Federal, State or local) transaction or contract under a public transaction; violation of Federal or State antitrust statutes or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, or receiving stolen property;

(C) Are not presently indicted for or otherwise criminally or civilly charged by a governmental entity (Federal, State or local) with commission of any of the offenses enumerated in paragraph (1)(B) of this certification;

(D) Have not within a three‑year period proceeding this application/proposal had one or more public transactions (Federal, State or local) terminated for cause or default.

(2) Where the prospective primary participant is unable to certify to any of the statements in this certification, such prospective participant shall attach an explanation to this proposal.

4. CERTIFICATION REGARDING LOBBYING

The undersigned certifies, to the best of his or her knowledge and belief, that:

(1) No Federal appropriated funds have been paid or will be paid, by or on behalf of the undersigned, to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with the awarding of any Federal contract, the making of any Federal grant, the making of any Federal loan, the entering into of any grant, and the extension, continuation, renewal, amendment or modification of any Federal contract, grant, loan, or grant.

(2) If any funds other than Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with this Federal contract, grant, loan, or grant, the undersigned shall complete and submit Standard Form‑LLL, "Disclosure of Lobbying Activities,"[8] in accordance with its instructions.

(3) The undersigned shall require that the language of this certification be included in the award documents for all sub-awards at all tiers (including subcontracts, sub-grants, and contracts under grants, loans, and grants) and that all sub-recipients shall certify and disclose accordingly.

This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Submission of this certification is a prerequisite for making or entering into this transaction imposed by section 1352, title 31, United States Code. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure.

Statement for Loan Guarantees and Loan Insurance

The undersigned states, to the best of his or her knowledge and belief, that: If any funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with this commitment providing for the United States to insure or guarantee a loan, the undersigned shall complete and submit Standard Form‑LLL, "Disclosure Form to Report Lobbying," in accordance with its instructions. Submission of this statement is a prerequisite for making or entering into this transaction imposed by section 1352, title 31, U.S. Code. Any person who fails to file the required statement shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure.

5. Prohibition on Assistance to Drug Traffickers for Covered Countries and Individuals (ADS 206)

USAID reserves the right to terminate this [Agreement/Contract], to demand a refund or take other appropriate measures if the [Grantee/Contractor] is found to have been convicted of a narcotics offense or to have been engaged in drug trafficking as defined in 22 CFR Part 140. The undersigned shall review USAID ADS 206 to determine if any certification is required for Key Individuals or Covered Participants.

If there are COVERED PARTICIPANTS: USAID reserves the right to terminate assistance to, or take or take other appropriate

measures with respect to, any participant approved by USAID who is found to have been convicted of a narcotics offense or

to have been engaged in drug trafficking as defined in 22 CFR Part 140.

6. CERTIFICATION OF RECIPIENT

The recipient certifies that it has reviewed and is familiar with the proposed grant format and the regulations applicable thereto, and that it agrees to comply with all such regulations, except as noted below (use a continuation page as necessary):

Solicitation No.

Application/Proposal No.

Date of Application/Proposal

Name of Recipient

Typed Name and Title

Signature Date

PART II

OTHER STATEMENTS OF RECIPIENT

1. AUTHORIZED INDIVIDUALS

The recipient represents that the following persons are authorized to negotiate on its behalf with the Government and to bind the recipient in connection with this application or grant:

Name Title Telephone No. Facsimile No.

2. TAXPAYER IDENTIFICATION NUMBER (TIN)

If the recipient is a U.S. organization, or a foreign organization which has income effectively connected with the conduct of activities in the U.S. or has an office or a place of business or a fiscal paying agent in the U.S., please indicate the recipient's TIN:

TIN:

3. CONTRACTOR IDENTIFICATION NUMBER--DATA UNIVERSAL NUMBERING SYSTEM (DUNS) NUMBER

(a) In the space provided at the end of this provision, the recipient should supply the Data Universal Numbering System (DUNS) number applicable to that name and address. Recipients should take care to report the number that identifies the recipient's name and address exactly as stated in the proposal.

(b) The DUNS is a 9‑digit number assigned by Dun and Bradstreet Information Services. If the recipient does not have a DUNS number, the recipient should call Dun and Bradstreet directly at 1‑800‑333‑0505. A DUNS number will be provided immediately by telephone at no charge to the recipient. The recipient should be prepared to provide the following information:

(1) Recipient's name.

(2) Recipient's address.

(3) Recipient's telephone number.

(4) Line of business.

(5) Chief executive officer/key manager.

(6) Date the organization was started.

(7) Number of people employed by the recipient.

(8) Company affiliation.

(c) Recipients located outside the United States may obtain the location and phone number of the local Dun and Bradstreet Information Services office from the Internet Home Page at http://www.dbisna.com/dbis/customer/custlist.htm. If an offeror is unable to locate a local service center, it may send an e‑mail to Dun and Bradstreet at [email protected].

The DUNS system is distinct from the Federal Taxpayer Identification Number (TIN) system.

DUNS:

4. LETTER OF CREDIT (LOC) NUMBER

If the recipient has an existing Letter of Credit (LOC) with USAID, please indicate the LOC number:

LOC: 72‑00‑

5. PROCUREMENT INFORMATION

(a) Applicability. This applies to the procurement of goods and services planned by the recipient (i.e., contracts, purchase orders, etc.) from a supplier of goods or services for the direct use or benefit of the recipient in conducting the program supported by the grant, and not to assistance provided by the recipient (i.e., a sub-grant or sub-agreement) to a sub-grantee or sub-recipient in support of the sub-grantee's or sub-recipient's program. Provision by the recipient of the requested information does not, in and of itself, constitute USAID approval.

(b) Amount of Procurement. Please indicate the total estimated dollar amount of goods and services which the recipient plans to purchase under the grant:

$

(c) Nonexpendable Property. If the recipient plans to purchase non-expendable equipment which would require the approval of the Agreement Officer, please indicate below (using a continuation page, as necessary) the types, quantities of each, and estimated unit costs. Non-expendable equipment for which the Agreement Officer's approval to purchase is required is any article of non-expendable tangible personal property charged directly to the grant, having a useful life of more than one year and an acquisition cost of $5,000 or more per unit.

Type/Description (Generic) Quantity Estimated Unit Cost

(d) Source, Origin, and Componentry of Goods. If the recipient plans to purchase any goods/commodities which are not of U.S. source and/or U.S. origin, and/or does not contain at least 50% componentry which are not at least 50% U.S. source and origin, please indicate below (using a continuation page, as necessary) the types and quantities of each, estimated unit costs of each, and probable source and/or origin, to include the probable source and/or origin of the components if less than 50% U.S. components will be contained in the commodity. "Source" means the country from which a commodity is shipped to the cooperating country or the cooperating country itself if the commodity is located therein at the time of purchase. However, where a commodity is shipped from a free port or bonded warehouse in the form in which received therein, "source" means the country from which the commodity was shipped to the free port or bonded warehouse. Any commodity whose source is a non‑Free World country is ineligible for USAID financing. The "origin" of a commodity is the country or area in which a commodity is mined, grown, or produced. A commodity is produced when, through manufacturing, processing, or substantial and major assembling of components, a commercially recognized new commodity results, which is substantially different in basic characteristics or in purpose or utility from its components. Merely packaging various items together for a particular procurement or re-labeling items does not constitute production of a commodity. Any commodity whose origin is a non‑Free World country is ineligible for USAID financing. "Components" are the goods which go directly into the production of a produced commodity. Any component from a non‑Free World country makes the commodity ineligible for USAID financing.

Type/Description Estimated Probable Source Probable Origin (Generic) Quantity Unit Cost Goods Components Goods Components

(e) Restricted Goods. If the recipient plans to purchase any restricted goods, please indicate below (using a continuation page, as necessary) the types and quantities of each, estimated unit costs of each, intended use, and probable source and/or origin. Restricted goods are Agricultural Commodities, Motor Vehicles, Pharmaceuticals, Pesticides, Rubber Compounding Chemicals and Plasticizers, Used Equipment, U.S. Government‑Owned Excess Property, and Fertilizer.

Type/Description Estimated Probable Probable (Generic) Quantity Unit Cost Intended Use Source Origin

(f) Supplier Nationality. If the recipient plans to purchase any goods or services from suppliers of goods and services whose nationality is not in the U.S., please indicate below (using a continuation page, as necessary) the types and quantities of each good or service, estimated costs of each, probable nationality of each non‑U.S. supplier of each good or service, and the rationale for purchasing from a non‑U.S. supplier. Any supplier whose nationality is a non‑Free World country is ineligible for USAID financing.

Type/Description Estimated Probable Supplier Nationality Rationale (Generic) Quantity Unit Cost (Non-U.S. Only) for non-U.S.

(g) Proposed Disposition. If the recipient plans to purchase any non-expendable equipment with a unit acquisition cost of $5,000 or more, please indicate below (using a continuation page, as necessary) the proposed disposition of each such item. Generally, the recipient may either retain the property for other uses and make compensation to USAID (computed by applying the percentage of federal participation in the cost of the original program to the current fair market value of the property), or sell the property and reimburse USAID an amount computed by applying to the sales proceeds the percentage of federal participation in the cost of the original program (except that the recipient may deduct from the federal share $500 or 10% of the proceeds, whichever is greater, for selling and handling expenses), or donate the property to a host country institution, or otherwise dispose of the property as instructed by USAID.

Type/Description (Generic) Quantity Estimated Unit Cost Proposed Disposition

6. PAST PERFORMANCE REFERENCES

On a continuation page, please provide a list of the ten most current U.S. Government and/or privately‑funded contracts, grants, grants, etc., and the name, address, and telephone number of the Contract/Agreement Officer or other contact person.

7. TYPE OF ORGANIZATION

The recipient, by checking the applicable box, represents that ‑

(a) If the recipient is a U.S. entity, it operates as [ ] a corporation incorporated under the laws of the State of , [ ] an individual, [ ] a partnership, [ ] a non-governmental nonprofit organization, [ ] a state or loc al governmental organization, [ ] a private college or university, [ ] a public college or university, [ ] an international organization, or [ ] a joint venture; or

(b) If the recipient is a non‑U.S. entity, it operates as [ ] a corporation organized under the laws of (country), [ ] an individual, [ ] a partnership, [ ] a non-governmental nonprofit organization, [ ] a non-governmental educational institution, [ ] a governmental organization, [ ] an international organization, or [ ] a joint venture.

8. ESTIMATED COSTS OF COMMUNICATIONS PRODUCTS

The following are the estimate(s) of the cost of each separate communications product (i.e., any printed material [other than non-color photocopy material], photographic services, or video production services) which is anticipated under the grant. Each estimate must include all the costs associated with preparation and execution of the product. Use a continuation page as necessary.

Attachment A

Page 1 of 2

Certification Regarding Debarment, Suspension, Ineligibility and Voluntary Exclusion

Lower Tier Covered Transactions

(a) Instructions for Certification

1. By signing and submitting this proposal, the prospective lower tier participant is providing the certification set out below.

2. The certification in this clause is a material representation of fact upon which reliance was placed when this transaction was entered into. If it is later determined that the prospective lower tier participant knowingly rendered an erroneous certification, in addition to other remedies available to the Federal Government, the department or agency with which this transaction originated may pursue available remedies, including suspension and/or debarment.

3. The prospective lower tier participant shall provide immediate written notice to the person to which this proposal is submitted if at any time the prospective lower tier participant learns that its certification was erroneous when submitted or has become erroneous by reason of changed circumstances.

4. The terms "covered transaction," "debarred," "suspended," ineligible, "lower tier covered transaction," "participant," "person," "primary covered transaction," "principal," "proposal," and "voluntarily excluded," as used in this clause, has the meanings set out in the Definitions and Coverage sections of rules implementing Executive Order 12549. 1/ You may contact the person to which this proposal is submitted for assistance in obtaining a copy of those regulations.

5. The prospective lower tier participant agrees by submitting this proposal that, should the proposed covered transaction be entered into, it shall not knowingly enter into any lower tier covered transaction with a person who is debarred, suspended, declared ineligible, or voluntarily excluded from participation in this covered transaction, unless authorized by the department or agency with which this transaction originated.

6. The prospective lower tier participant further agrees by submitting this proposal that it will include this clause titled "Certification Regarding Debarment, Suspension, Ineligibility and Voluntary Exclusion‑‑Lower Tier covered Transaction," 2/ without modification, in all lower tier covered transactions and in all solicitations for lower tier covered transactions.

7. A participant in a covered transaction may rely upon a certification of a prospective participant in a lower tier covered transaction that it is not debarred, suspended, ineligible, or voluntarily excluded from the covered transaction, unless it knows that the certification is erroneous. A participant may decide the method and frequency by which it determines the eligibility of its principals. Each participant may, but is not required to, check the Non procurement List.

8. Nothing contained in the foregoing shall be construed to require establishment of a system of records in order to render in good faith the certification required by this clause. The knowledge and information of a participant is not required to exceed that which is normally possessed by a prudent person in the ordinary course of business dealings.

9. Except for transactions authorized under paragraph 5 of these instructions, if a participant in a covered transaction knowingly enters into a lower tier covered transaction with a person who is suspended, debarred, ineligible, or voluntarily excluded from participation in this transaction, in addition to other remedies available to the Federal Government, the department or agency with which this transaction originated may pursue available remedies, including suspension and/or debarment.

1/ See ADS Chapter 303, 22 CFR 208.

2/ For USAID, this clause is entitled "Debarment, Suspension, Ineligibility, and Voluntary Exclusion (March 1989)" and is set forth in the USAID grant standard provision for U.S. non-governmental organizations entitled "Debarment, Suspension, and Related Matters" (see ADS Chapter 303), or in the USAID grant standard provision for non‑U.S. non-governmental organizations entitled "Debarment, Suspension, and Other Responsibility Matters" (see ADS Chapter 303).

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(b) Certification Regarding Debarment, Suspension, Ineligibility and Voluntary Exclusion‑‑Lower Tier Covered Transactions

(1) The prospective lower tier participant certifies, by submission of this proposal, that neither it nor its principals is presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any Federal department or agency.

(2) Where the prospective lower tier participant is unable to certify to any of the statements in this certification, such prospective participant shall attach an explanation to this proposal.

Solicitation No.

Application/Proposal No.

Date of Application/Proposal

Name of Applicant/Sub-grantee

Typed Name and Title

Signature Date

KEY INDIVIDUAL CERTIFICATION NARCOTICS OFFENSES AND DRUG TRAFFICKING

I hereby certify that within the last ten years:

1. I have not been convicted of a violation of, or a conspiracy to violate, any law or regulation of the United States or any other country concerning narcotic or psychotropic drugs or other controlled substances.

2. I am not and have not been an illicit trafficker in any such drug or controlled substance.

3. I am not and have not been a knowing assistor, abettor, conspirator, or colluder with others in the illicit trafficking in any such drug or substance.

Signature: ________________________

Date: _______________________

Name: ___________________________

Title/Position: ____________________________

Organization: _____________________________

Address: ________________________________

___________________________________

Date of Birth: ______________________________

NOTICE:

1. You are required to sign this Certification under the provisions of 22 CFR Part 140, Prohibition on Assistance to Drug Traffickers. These regulations were issued by the Department of State and require that certain key individuals of organizations must sign this Certification.

2. If you make a false Certification you are subject to U.S. criminal prosecution under 18 U.S.C. 1001.

PARTICIPANT CERTIFICATION NARCOTICS OFFENSES AND DRUG TRAFFICKING

1. I hereby certify that within the last ten years:

a. I have not been convicted of a violation of, or a conspiracy to violate, any law or regulation of the United States or any other country concerning narcotic or psychotropic drugs or other controlled substances.

b. I am not and have not been an illicit trafficker in any such drug or controlled substance.

c. I am not or have not been a knowing assistor, abettor, conspirator, or colluder with others in the illicit trafficking in any such drug or substance.

2. I understand that USAID may terminate my training if it is determined that I engaged in the above conduct during the last ten years or during my USAID training.

Signature: ___________________________________

Name: ______________________________________

Date: _______________________________

Address: ______________________________

_______________________________

Date of Birth: __________________________________

NOTICE:

1. You are required to sign this Certification under the provisions of 22 CFR Part 140,Prohibition on Assistance to Drug Traffickers. These regulations were issued by the Department of State and require that certain participants must sign this Certification.

2. If you make a false Certification you are subject to U.S. criminal prosecution under 18 U.S.C. 1001.

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[1] See Hector Quemada’s consulting report

[2] Under TRIPS countries have the choice to provide sui generis protection to a plant cultivar usually through an UPOV(International Union for the Protection of New Varieties of Plants) like legislation

[3]FORMATS\GRNTCERT: Rev. 06/16/97 (ADS 303.6, E303.5.6a)

[4]When these Certifications, Assurances, and Other Statements of Recipient are used for grants, the term "Grant" means "Grant".

[5]The recipient must obtain from each identified subgrantee and (sub)contractor, and submit with its application/proposal, the Certification Regarding Debarment, Suspension, Ineligibility and Voluntary Exclusion ‑‑ Lower Tier Transactions, set forth in Attachment A hereto. The recipient should reproduce additional copies as necessary.

[6]See ADS Chapter E303.5.6a, 22 CFR 208, Annex1, App A.

[7]For USAID, this clause is entitled "Debarment, Suspension, Ineligibility, and Voluntary Exclusion (March 1989)" and is set forth in the grant standard provision entitled "Debarment, Suspension, and Related Matters" if the recipient is a U.S. nongovernmental organization, or in the grant standard provision entitled "Debarment, Suspension, and Other Responsibility Matters" if the recipient is a non‑U.S. nongovernmental organization.