Agricultural Biotechnology APS .pdf

Issue Date: November 21, 2019

Deadline for APS Questions: December 06, 2019

Closing Date: November 20, 2020

Closing Time: 23:59 EST

Subject: Annual Program Statement (APS) Number: 7200AA20APS00003

Program Title: Agricultural Biotechnology for Global Food Security

Catalog of Federal Domestic Assistance (CFDA) Number: 98.001

Dear Applicants, The United States Agency for International Development (USAID) seeks to notify qualified organizations about forthcoming opportunities to implement the Agricultural Biotechnology for

Global Food Security program described in this Annual Program Statement (APS), and in further detail under published Addenda to this APS. Please note that this APS describes the overarching program USAID is interested in funding in this space, however, funding opportunities will be available only at the Addendum level, and will be published separately on www.grants.gov.

USAID intends to issue multiple awards by way of funded Addenda to the applicant(s) who best meets the objectives based on the general merit review criteria described in this APS and the more specific criteria outlined in subsequent Addenda. Eligible parties interested in responding to a given Addendum are encouraged to thoroughly read this APS and the relevant Addendum to understand the type of program sought, application submission requirements, and the selection process. Eligibility for awards resulting from Addenda under this APS is not restricted.

To be eligible for award, the applicant must provide all information as required in this APS and meet eligibility standards in Section C of this APS. This APS is posted on www.grants.gov, and may be amended. It is the responsibility of the applicant to regularly check the website to ensure they have the latest information pertaining to this notice of funding opportunity and to ensure that the APS and relevant Addenda have been received from the internet in its entirety. USAID bears no responsibility for data errors resulting from transmission or conversion process. If you have difficulty registering on www.grants.gov or accessing the APS or Addendum, please contact the Grants.gov Helpdesk at 1-800-518-4726 or via email at support@grants.gov for technical assistance.

USAID may not issue an award to an applicant unless the applicant has complied with all applicable unique entity identifier and System for Award Management (SAM) requirements detailed in Section D.V.f. The registration process may take many weeks to complete. Therefore, applicants are encouraged to begin registration early in the process.

http://www.grants.gov/ mailto:support@grants.gov

Agricultural Biotechnology for Global Food Security Annual Program Statement: No.7200AA20APS00003 Page 2

Please send any questions to the point(s) of contact identified in Section D. The deadline for questions on the APS is shown above. Responses to questions on the APS received prior to the deadline will be furnished to all potential applicants through an amendment to this notice posted to www.grants.gov.

This Annual Program Statement is unfunded, and issuance of this APS does not constitute an award commitment on the part of the Government, nor does it commit the Government to pay for any costs incurred in preparation or submission of comments/suggestions or an application.

Applications are submitted at the risk of the applicant. All preparation and submission costs are at the applicant’s expense.

Thank you for your interest in USAID programs.

Sincerely, Paul Burford

Agreement Officer

Agricultural Biotechnology for Global Food Security Annual Program Statement: No.7200AA20APS00003 Page 3

Table of Contents

Section A: Background and Program Description ………………………………………….…Pg 4

Section B – Federal Award Information……………………………………………………...Pg 23

Section C – Eligibility Information………………………………………………………..…Pg 26

Section D – Application and Submission Information……………………………………….Pg 27

Section E – Application Review Information………………………………………………...Pg 44

Section F – Federal Award Administration Information………………………………….….Pg 44

Section G – Federal Awarding Agency Contacts…………………………………………… Pg 50

Section H – Information Protection…………………………………………………………. Pg 50

Section I: Additional Information on Award Administration …………………..…………... Pg 51

Agricultural Biotechnology for Global Food Security Annual Program Statement: No.7200AA20APS00003 Page 4

SECTION A: BACKGROUND AND PROGRAM DESCRIPTION

I: BACKGROUND

a. Definition of Agricultural Biotechnology Under this APS

For the purposes of this APS, “Agricultural Biotechnology” refers to the technologies used for the deliberate manipulation of an organism to introduce, remove, or modify one or more heritable characteristics of a product for agricultural use; and to overcome natural physiological reproductive or recombination barriers, with emphasis on in vitro nucleic acid techniques, including recombinant DNA or direct injection of nucleic acid into cells or organelles. Examples include, but are not limited to, “traditional” genetic engineering (GE) approaches (e.g.., transgenic organisms, genetically modified organisms, living modified organisms, etc.), and emerging approaches for gene editing and precision breeding (e.g., CRISPR-Cas9, TALENs, zinc-finger nucleases, etc.).

Within the scope of this definition of Agricultural Biotechnology, USAID includes under this

Agricultural Biotechnology APS all potential applications of agricultural biotechnology as a tool to achieve global food security objectives—ranging from crop improvement, livestock and veterinary applications, agricultural pest and disease control, to food safety and processing, and beyond.

Note that this definition of agricultural biotechnology specifically excludes technologies used in conventional breeding and selection, such as genomics- or marker-assisted breeding. It also excludes more broadly defined connotations of the term “agricultural biotechnology” as any application of biology to address agricultural challenges (such as rhizobial inoculants or tissue culture, for example). Though important in their own right, USAID supports such approaches under other Feed the Future programs.

b. USAID’s Approach to Global Food Security

The U.S. Government defines food security as the availability, utilization, and stability of sufficient food to meet caloric and nutritional needs for an active and healthy life. In the wake of the 2007/2008 global food price spikes, it was widely recognized that food security represents a pressing humanitarian challenge that has important consequences for global stability and security. In 2010, this led the U.S. Government to develop the Feed the Future Initiative -- its signature effort to reduce global hunger, undernutrition, and extreme poverty.

After an initial five-year period of food security programming in selected partner countries, Feed the Future’s track record of successful results and critical contributions to the U.S. economy, security and leadership culminated in the enactment of the 2016 Global Food Security Act

Agricultural Biotechnology for Global Food Security Annual Program Statement: No.7200AA20APS00003 Page 5

(GFSA).

With its signature goals of sustainably reducing global hunger, malnutrition and poverty, the GFSA authorized a new phase of U.S. Government engagement in global food security programming.

To reflect changes in the global context since the initial launch of Feed the Future, as well as lessons learned during the initiative’s first phase, the GFSA called for a new, whole-of-government strategy to focus and coordinate resources and programming across Feed the

Future’s eleven U.S. Government partner agencies. The resulting 2017-2021 Global Food

Security Strategy (GFSS) describes in detail how the U.S. intends to direct Feed the Future resources and programming to achieve the topline goals of the GFSA (Figure 1).

Figure 1. GFSS Results Framework (2017-2021).

https://www.congress.gov/bill/114th-congress/house-bill/1567 https://www.usaid.gov/what-we-do/agriculture-and-food-security/us-government-global-food-security-strategy https://www.congress.gov/bill/114th-congress/house-bill/1567 https://www.usaid.gov/what-we-do/agriculture-and-food-security/us-government-global-food-security-strategy https://www.usaid.gov/what-we-do/agriculture-and-food-security/us-government-global-food-security-strategy

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The GFSS serves as the framework under which USAID and its inter-Agency partners currently design and implement all Feed the Future programs—including agricultural biotechnology programming planned under this APS.

Collectively, Feed the Future programs under the GFSS contribute to three high-level development objectives:

1. Inclusive and sustainable agriculture-led growth.

In development contexts, agricultural growth has been shown to be the most effective means for reducing poverty through direct and indirect pathways. Feed the Future programming therefore seeks to promote agriculture-led growth by increasing sustainable agricultural productivity; strengthening productive, profitable, inclusive agricultural systems; strengthening and expanding access to markets and trade; and increasing employment and entrepreneurship.

2. Strengthened resilience among people and systems.

Resilience is the ability of people, households, communities, and systems to reduce, mitigate, adapt to and recover from shocks and stresses in a manner that reduces chronic vulnerability and facilitates inclusive growth. It is an essential condition for sustainably reducing global hunger, malnutrition, and poverty, as well as to reduce reliance upon emergency food assistance. Feed the Future programming therefore seeks to identify, develop, support, and strengthen resilience capacities across multiple scales by increasing sustainable agricultural productivity—particularly through climate-smart approaches;

improving proactive risk reduction, mitigation, and management; and improving adaptation to and recovery from shocks and stresses.

3. A well-nourished population, especially among women and children.

Promoting the availability, access, and consumption of diverse, safe foods is a key element of food security under the GFSS. Using a multi-sectoral approach, Feed the

Future applies both nutrition-specific and nutrition-sensitive approaches to increase consumption of nutritious and safe diets; increase use of direct nutrition interventions and services; and cultivate more hygienic household and community environments.

In addition to these three overarching strategic objectives, several other GFSS cross-cutting objectives and broader USAID strategic priorities are relevant to the design and implementation

Additional technical guidance regarding U.S. Government approaches to global food security can be found online at: https://www.feedthefuture.gov/guidance-and-tools-for-global-food-security-programs/.

https://www.feedthefuture.gov/resource/global-food-security-strategy-technical-guidance-on-agriculture-led-economic-growth/ https://www.feedthefuture.gov/resource/global-food-security-strategy-guidance-on-resilience/ and https://www.usaid.gov/resilience/resources https://www.feedthefuture.gov/resource/global-food-security-strategy-technical-guidance-on-nutrition/ https://www.feedthefuture.gov/guidance-and-tools-for-global-food-security-programs/ https://www.feedthefuture.gov/resource/global-food-security-strategy-technical-guidance-on-agriculture-led-economic-growth/ https://www.feedthefuture.gov/resource/global-food-security-strategy-technical-guidance-on-agriculture-led-economic-growth/ https://www.feedthefuture.gov/resource/global-food-security-strategy-guidance-on-resilience/ https://www.usaid.gov/resilience/resources https://www.feedthefuture.gov/resource/global-food-security-strategy-technical-guidance-on-nutrition/

Agricultural Biotechnology for Global Food Security Annual Program Statement: No.7200AA20APS00003 Page 7 of Feed the Future programming, including programming in the area of agricultural biotechnology. These include:

4. Local Capacity Development and the Journey to Self-Reliance

Under the GFSS, USAID’s approach to improving human, organizational and system performance is rooted in local capacity development, a “process of unleashing, strengthening, and maintaining the ability of people, organizations, and society as a whole to manage their affairs successfully.”

USAID strongly emphasizes the importance of capacity development to improve food security outcomes, impacts and sustainability by increasing local ownership through partnerships across all levels of society― government, civil society, the private sector, academia, etc.. This includes supporting partner countries’ capacity to plan, finance and implement solutions to local development challenges; and strengthening their commitment to see these through effectively, inclusively, and with accountability―or what USAID terms a country’s “journey to self-reliance.”

(In this context, commitment refers to the degree to which a country’s actions―its laws, policies, informal norms and practices―enable it to address its development challenges.)

5. Country Ownership and Alignment with USAID Mission Objectives

The U.S. Government promotes sustainability and effectiveness by emphasizing local ownership of food security priorities and strategy, alignment around a country’s development strategy, and collaborative partnerships among development partners and local actors inspired by the values of the High Level Fora on Aid Effectiveness and outlined in the Paris Declaration and related partnership agreements. Within USAID’s internal organizational context, local USAID Missions lead the process of adapting the high-level priorities and principles of the GFSS to suit the unique priorities and context of their respective partner countries or regions. Through the development of Global Food

Security Plans for each GFSS Target Country and Region, USAID Missions and their inter-Agency partners coordinate across a variety of partners and resources to identify shared agricultural, resilience, and nutrition priorities for investment and programming, including the identification of focal value chains and market systems.

USAID-funded agricultural research and development programs, projects, and activities therefore respond to global strategies such as the GFSS, but also contribute to country and regional agendas as articulated in these GFS Country and Regional Plans.

Organization for Economic Cooperation and Development – Development Assistance Committee.

(2006). The Challenge of Capacity Development: Working Towards Good Practice, Paris, http://www.fao.org/fileadmin/templates/capacitybuilding/pdf/DAC_paper_final.pdf https://www.usaid.gov/selfreliance

See https://www.feedthefuture.gov/about/ for a list of GFSS target countries, and links to further country-specific information.

http://www.fao.org/fileadmin/templates/capacitybuilding/pdf/DAC_paper_final.pdf https://www.usaid.gov/selfreliance https://www.feedthefuture.gov/about/

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6. Partnership and Private Sector Engagement

The GFSS embraces partnerships with a wide range of development actors and groups across the public and private sectors in order to improve the reach, effectiveness, efficiency, and sustainability of the U.S. Government’s food security efforts. Consistent with USAID’s 2018 Private Sector Engagement (PSE) Policy, Feed the Future programming particularly emphasizes engagement with a wide range of private-sector entities―including for-profit commercial entities and their affiliated foundations;

financial institutions, investors, and intermediaries; business associations and cooperatives; micro, small, medium and large enterprises that operate in the formal and informal sectors; local, regional, American, and multinational businesses; and for-profit approaches that generate sustainable income (e.g. a venture fund run by an NGO or social enterprise). By pursuing market-based approaches to achieve results, engaging with private-sector actors throughout design and implementation, and partnering with commercial partners that offer unique value, food security activities under the GFSS seek to address the scale and complexity of food security challenges effectively and sustainably.

7. Increased Gender Equality and Female Empowerment

USAID policy requires that gender equality be addressed as appropriate in all USAID-funded activities, and programming contribute to Gender and Female Empowerment

Policy objectives and the GFSS Cross-cutting Intermediate Result of advancing gender equity and female empowerment.

Accordingly, while not all Feed the Future programming will specifically emphasize gender outcomes as a topline objective, all activities must be implemented in a gender-sensitive manner―developing knowledge, recommendations, tools, and strategies that recognize and account for the needs and multi-dimensional roles of both women and men in innovation, production and marketing systems. Gender analysis and integration must be implemented as a cross-cutting effort within all activities.

8. Increased Youth Empowerment and Livelihoods

In addition to the gender requirements noted above, the 2012 Youth in Development

Policy mandates the inclusion of youth (ages 10 – 29) across USAID’s portfolio, while the GFSS has committed itself to mainstreaming youth in agriculture, food security and https://pages.usaid.gov/sites/default/files/usaid_psepolicy_final_signed.pdf https://www.feedthefuture.gov/wp-content/uploads/2018/03/GFSS_TechnicalGuidance_Private%20Sector%20Engagement.pdf https://www.usaid.gov/sites/default/files/documents/1865/GenderEqualityPolicy_0.pdf https://www.feedthefuture.gov/resource/global-food-security-strategy-technical-guidance-on-advancing-gender-equality-and-female-empowerment/

The Women’s Entrepreneurship and Economic Empowerment Act of 2018 codifies USAID's gender analysis requirements: https://www.congress.gov/bill/115th-congress/senate-bill/3247/text https://www.usaid.gov/policy/youth https://pages.usaid.gov/sites/default/files/usaid_psepolicy_final_signed.pdf https://www.feedthefuture.gov/wp-content/uploads/2018/03/GFSS_TechnicalGuidance_Private%20Sector%20Engagement.pdf https://www.feedthefuture.gov/wp-content/uploads/2018/03/GFSS_TechnicalGuidance_Private%20Sector%20Engagement.pdf https://www.usaid.gov/sites/default/files/documents/1865/GenderEqualityPolicy_0.pdf https://www.feedthefuture.gov/resource/global-food-security-strategy-technical-guidance-on-advancing-gender-equality-and-female-empowerment/ https://www.feedthefuture.gov/resource/global-food-security-strategy-technical-guidance-on-advancing-gender-equality-and-female-empowerment/ https://www.congress.gov/bill/115th-congress/senate-bill/3247/text https://www.usaid.gov/policy/youth

Agricultural Biotechnology for Global Food Security Annual Program Statement: No.7200AA20APS00003 Page 9 nutrition using a Positive Youth Development framework.

Accordingly, while not all

Feed the Future programming will specifically emphasize youth outcomes as a topline objective, all activities must be implemented in a youth-sensitive manner, by developing knowledge, recommendations, tools, and strategies that recognize and account for the needs and multi-dimensional roles of youth in small-scale production and marketing systems, with youth analysis and inclusion implemented as a cross-cutting effort within all activities.

9. Collaborating, Learning, and Adapting (CLA)

Strategic collaboration, continuous learning, and adaptive management are a set of practices that link together all components of USAID’s Program Cycle. This linkage ensures that the U.S. Government’s international development programming is coordinated with others, grounded in a strong evidence base, and iteratively adapted to remain relevant throughout implementation.

Those designing and implementing USAID activities are expected to systematically apply CLA approaches. Implementing partners assume particular responsibility for monitoring progress, evaluating impact, and adapting activities in response to new evidence or changing circumstances to improve development outcomes and ensure accountability for the resources used to achieve them.

In particular, strong Knowledge Management (KM) and communications practices are essential in order for USAID and its partners to ensure that knowledge is generated, captured, shared, and applied systematically and strategically so there is continuous learning, effective engagement, and organizational improvement. Effective KM and communication also helps stimulate innovative ideas, capitalize on effective practices, foster better decision-making and build a more informed workforce.

c. The Research-to-Scaling Continuum under the Global Food Security Strategy

Achieving the U.S. Government’s high-level food security and development goals in a complex, dynamic global context requires innovative approaches. Accordingly, research and innovation are a fundamental part of Feed the Future: The GFSA explicitly calls for U.S. investments to

“harness science, technology and innovation,” and the GFSS highlights that research investments

“ensure a pipeline of innovations, tools and approaches designed to improve agriculture, food security, resilience and nutrition priorities in the face of complex, dynamic challenges.”

To ensure that Feed the Future strategically leverages U.S. scientific capabilities and resources to catalyze global food security efforts, the 2017 Global Food Security Research Strategy describes how Feed the Future programming will direct its food security research-for-development investments in order to best support GFSS development objectives.

https://www.youthpower.org/positive-youth-development-toolkit

See https://usaidlearninglab.org/ or https://www.agrilinks.org/topics/monitoring-evaluation-and-learning for further information and resources.

https://www.feedthefuture.gov/resource/the-u-s-government-s-global-food-security-research-strategy/ https://www.youthpower.org/positive-youth-development-toolkit https://usaidlearninglab.org/ https://www.agrilinks.org/topics/monitoring-evaluation-and-learning https://www.feedthefuture.gov/resource/the-u-s-government-s-global-food-security-research-strategy/

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To accomplish this, Feed the Future research programs emphasize applied and adaptive research, linking global, regional, and national research partners to identify and adapt promising methodologies and technologies for local farming systems in developing countries, and to intensify and diversify major production systems where the poor and undernourished are concentrated. In doing so, research investment spans a wide array of technical themes and approaches―including (but not limited to) crop and livestock improvement; post-harvest loss reduction; nutrition and food safety; sustainable intensification of farming systems; natural resource management; and socioeconomic and policy research. Within this broader research context, agricultural biotechnology represents a powerful set of scientific tools, with the potential to enable transformative innovation across a variety of research domains.

As described in the GFS Research Strategy, research represents one stage within a continuous, iterative process by which new food security innovations (including technologies, practices, and knowledge) are developed, disseminated, adopted, and used in order to enhance prosperity, resilience, and nutrition. The continuous nature of this process is particularly worth noting, as

USAID agricultural biotechnology programming under this APS may include activities at all phases of the research-to-development pipeline.

In order for new innovations to ultimately yield maximum impact in developing countries, a facilitative approach is typically required to move from the research stage, to initial adoption by a small number of direct beneficiaries, and ultimately to achieve widespread, sustained adoption at the population level (e.g., hundreds of thousands to millions, depending on the innovation and context). To successfully achieve technology scaling―the process by which a technology is sustainably adopted by a progressively larger number of users over time―USAID’s investments in research and innovation emphasize continuity throughout and beyond the research phase.

In order to maximize the potential for research outputs to ultimately achieve development impact, USAID ensures that best practices to promote technology scaling are integrated into research activities from the earliest stages of design and implementation. These include:

1. Gathering and applying market intelligence about the products and traits desired by intended beneficiaries, to inform early-stage research and product design.

2. During initial R&D activity design and implementation, identifying potential product delivery and dissemination pathways that will ultimately support the diffusion of an innovation.

3. Cultivating active and increasing collaboration between researchers and potential scaling partners as innovations advance through the research and development process, beginning with the earliest phase of research prioritization and design.

https://www.feedthefuture.gov/resource/global-food-security-strategy-technical-guidance-on-scaling/ https://www.feedthefuture.gov/resource/global-food-security-strategy-technical-guidance-on-scaling/

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4. Using participatory research methodologies that engage intended end-users and potential public or private sector disseminators in co-design and testing of innovations, ensuring that traits and characteristics preferred downstream are selected for early in the research process.

5. Soliciting and responding to ongoing, iterative feedback from end-users, stakeholders and technology scaling partners to inform upstream research activities throughout the research pipeline.

To facilitate successful technology scaling, USAID agricultural development approaches particularly consider the structure and function of local product supply and distribution systems, in order to promote effective, equitable dissemination of agricultural inputs and other technologies to their intended beneficiaries.

d. Enabling Systems for Innovation and Market Function

To successfully advance agricultural technologies from inception through research, development, and scaling―and ultimately to achieve widespread food security benefits―a network of actors must perform the underlying scientific, extension, and market functions that support these processes. Through concepts such as Agricultural Innovation Systems and Inclusive Market

Systems, USAID emphasizes development approaches that not only supply new technologies, but also strengthen the enabling system of organizations, relationships, and processes that enable their development and dissemination in partner countries.

USAID’s innovation- and market-systems approaches rely on facilitation of local systems―the interconnected sets of producers, market actors, researchers, and consumers, including governments, civil society, the private sector, universities, individual citizens, and others―to collectively drive sustainable innovation and market development.

Such approaches foster productive interactions between individuals and organizations across the domains of research and education; the private sector and markets; and agricultural extension and other “bridging institutions” across these various domains. They also expand focus from the farm level to include a broader perspective on all functions and relationships along a value chain, as well as consider and contribute to the broader agriculture enabling environment―which comprises all of the informal and formal norms, traditions, customs, laws, regulations, policies, trade agreements, and infrastructure that drive behavior and decisions within the system.

For example, seed-system analyses are important to inform programming and engagement on improved crop varieties; further information available at https://www.agrilinks.org/events/strengthening-early-generation-seed-systems-africa-and-beyond) https://www.feedthefuture.gov/resource/global-food-security-strategy-technical-guidance-on-capacity-development/ https://www.feedthefuture.gov/resource/global-food-security-strategy-guidance-on-market-systems-and-value-chains/ https://www.usaid.gov/policy/local-systems-framework https://www.agrilinks.org/events/strengthening-early-generation-seed-systems-africa-and-beyond https://www.agrilinks.org/events/strengthening-early-generation-seed-systems-africa-and-beyond https://www.feedthefuture.gov/resource/global-food-security-strategy-technical-guidance-on-capacity-development/ https://www.feedthefuture.gov/resource/global-food-security-strategy-technical-guidance-on-capacity-development/ https://www.feedthefuture.gov/resource/global-food-security-strategy-guidance-on-market-systems-and-value-chains/ https://www.feedthefuture.gov/resource/global-food-security-strategy-guidance-on-market-systems-and-value-chains/ https://www.usaid.gov/policy/local-systems-framework

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In the context of agricultural development―and particularly agricultural biotechnology―policy systems represent one crucial element of the broader enabling environment.

Defined as the set of legislative, executive and judiciary rules, regulations, statutes, etc., that govern the agricultural and food system, policy systems consist of three components:

1. The policy agenda is a set of prioritized policy changes;

2. Institutional architecture is the formal and informal structure in which policy is formulated and implemented; and

3. Mutual accountability stems from the observation that development is a multi-stakeholder phenomenon, which works best when all stakeholders are accountable to themselves and others for their individual roles, and the set of stakeholders is jointly accountable for ensuring that the set of actions is sufficient to make needed progress. (For example, government might be accountable for creating enabling policies and space for inclusive, evidence-based dialog; the private sector for commercializing locally appropriate products; farmers’ and consumers’ groups for articulating what they value; and civil society for participating in objective, evidence-based dialog.)

All participants in policy systems must have sufficient capacity to execute their responsibilities, so capacity building is often a critical component of policy systems strengthening. Stronger policy systems in turn strengthen agricultural and food systems to significantly accelerate inclusive agricultural growth, catalyze key sector outcomes, and support a country’s journey to self-reliance.

e. Investment Rationale: Agricultural Biotechnology as a Tool for Global Food Security

Since the early 1990s, USAID has supported agricultural biotechnology programming as one element of its broader food security research and development portfolio. This longstanding investment is rooted in the premise that agricultural biotechnology provides a powerful, flexible set of tools for agricultural innovation, offering extraordinary potential to drive sustainable food security and development gains not possible with conventional approaches. Through its agricultural biotechnology programming, USAID has supported partner countries that seek equitable access to the full toolkit of modern agriculture―expanding the options available to developing-country innovators and farmers to address local food security and development priorities.

Though the impacts of agricultural biotechnology depend on the specific products and traits under consideration, illustrative examples of biotechnology’s potential to drive development gains for smallholders in developing countries include:

https://www.feedthefuture.gov/resource/global-food-security-strategy-technical-guidance-on-policy-programming/ https://www.feedthefuture.gov/resource/global-food-security-strategy-technical-guidance-on-policy-programming/ https://www.feedthefuture.gov/resource/global-food-security-strategy-technical-guidance-on-policy-programming/

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1. Productivity traits reduce the quantity of inputs (e.g. land, water, feed, fertilizer, labor, pesticides, etc.) required to maintain and increase yields, thereby enhancing both environmental sustainability and smallholder profitability.

2. New traits and approaches to help control pests and diseases increase the resilience of crop and animal production systems―and the households and communities whose livelihoods rely on them―in the face of biotic stresses.

3. A wide array of stress tolerance traits (e.g. for drought, heat, low soil fertility, etc.)

help stabilize agricultural production in the face of climate extremes and other abiotic shocks and stresses.

4. Biotechnological approaches to biofortification enhance the nutritional content of food and feed, while novel food-safety traits minimize accumulation of harmful compounds such as mycotoxins or heavy metals in agricultural products―thereby improving human and animal health.

5. Enhanced quality traits and processing technologies address local market preferences and stimulate opportunities for value addition and trade within local market systems.

6. Adoption of the products of agricultural biotechnology results in aggregate productivity, quality and safety gains (or averted losses due to improved resilience to shocks and stresses) that add hundreds of millions of dollars per year to developing-country economies.

Despite these potential benefits for food security and sustainability in USAID partner countries, persistent challenges have historically slowed the development and application of agricultural biotechnology to address global food security concerns. Some of these are generic challenges common to agricultural development efforts more broadly, though they may be particularly acute in the context of agricultural biotechnology: Local partners may lack capacity or resources to independently develop and disseminate locally appropriate agricultural innovations. Conversely, market actors with sufficient capacity and resources typically focus on the more profitable global commercial agriculture sector, as fragmentation and risk in developing-country markets deters investment in products relevant to smallholder farmers.

Beyond these common challenges, agricultural biotechnology faces additional obstacles of public awareness and perception. These arise from negative messages about the safety and appropriateness of agricultural biotechnology that have been widely popularized, often without robust scientific evidence. Combined with low levels of public scientific literacy, such negative rhetoric can leave key stakeholders and the public wary of biotechnological approaches. As a result, many developing countries have been slow to develop enabling policy or regulatory systems, further dis-incentivizing innovation and investment in agricultural biotechnology solutions relevant to smallholder farmers in these countries. Furthermore, lack of policy harmonization can lead to asynchronous regulatory approvals for agricultural biotechnology products across regional and global trade networks—fragmenting markets, raising concerns of

Agricultural Biotechnology for Global Food Security Annual Program Statement: No.7200AA20APS00003 Page 14 potential trade disruptions, and in some cases impeding timely delivery of humanitarian assistance.

Despite these challenges, emerging trends suggest that many years of effort by developing-country innovators and policymakers have fostered significant progress towards the prudent application of agricultural biotechnology to address global food security challenges. Consistent with these trends, potential entry points for USAID engagement and programming include:

1. A growing number of developing countries are exploring agricultural biotechnology as a tool to achieve their development goals. Since 2012, developing and middle-income countries have surpassed developed countries in the area planted to GE crops.

Amidst intensifying food security and climate challenges―and in acknowledgment of the strong, decades-long safety record of agricultural biotechnology products worldwide―a growing number of developing countries are exploring the development and use of locally appropriate agricultural biotechnology products. This includes, for example, the development of enabling policy and regulatory instruments; establishment of regulatory authorities and/or regulatory coordination frameworks; and achievement of key product development benchmarks, such as implementation of Confined Field Trials and issuance of environmental release approvals. Partners’ growing interest in agricultural biotechnology increases the potential geographic scope for USAID’s Agricultural

Biotechnology Program to engage with and support partner countries and regions. It also expands opportunities for facilitative approaches to promote regional and bilateral exchange of knowledge, experiences, and solutions between developing countries.

Conversely, this trend creates challenges of programmatic efficiency and strategic prioritization, in order to maximize the development impact of limited USAID resources across proliferating geographic priorities and growing demand for technical support in the area of agricultural biotechnology.

2. Longstanding agricultural biotechnology product development efforts are increasingly approaching market―and in some cases reaching smallholders―in developing countries.

3. New tools and approaches are expanding the potential applications and impacts of agricultural biotechnology. Rapid scientific advances are improving the speed, precision, cost, and range of potential applications of agricultural biotechnology; this, in turn, creates new opportunities to drive food security innovation and impact. USAID programming and partnerships can help developing-country scientists access emerging tools and approaches and bring them to bear on agricultural species, traits, and systems important to local smallholder farmers and consumers. In parallel, these technological http://www.isaaa.org/resources/publications/briefs/53/download/isaaa-brief-53-2017.pdf http://www.isaaa.org/resources/publications/briefs/53/download/isaaa-brief-53-2017.pdf

Agricultural Biotechnology for Global Food Security Annual Program Statement: No.7200AA20APS00003 Page 15 advances also drive partner-country demand for technical support and capacity development on corresponding policy and regulatory issues―such as, for example, gene editing; genetically improved animals; ongoing efforts to engineer, test, and disseminate effective recombinant livestock vaccines; or the potential development of gene drives to control disease or pests at the landscape level.

In summary, agricultural biotechnology represents a unique, powerful set of tools with potential to catalyze developing-country innovation and address global food security challenges, consistent with USAID’s programmatic investments under the GFSS and Global Food Security

Strategy. Accordingly, USAID has a decades-long history of investment in agricultural biotechnology as one element of its broader portfolio of research-for-development efforts. These investments have historically aimed to address productivity, resilience, nutritional, and environmental challenges relevant to smallholder production systems in developing countries―while simultaneously supporting partner countries’ efforts to build technical and regulatory capacity. Moving forward, trends such as the application of new biotechnological tools, the release of locally relevant agricultural biotechnology products in developing countries, and the growing number of countries and stakeholders exploring the potential benefits of agricultural biotechnology, provide promising entry points for USAID engagement.

II: PROGRAM DESCRIPTION

This APS is authorized under the Foreign Assistance Act (FAA) of 1961, as amended. Any awards resulting from Addenda under this APS will be subject to 2 CFR 200 – Uniform

Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, and

USAID’s supplement, 2 CFR 700, as well as any additional requirements found in Section F.

This Agricultural Biotechnology APS is not a Request for Applications (RFA), and it is unfunded. This APS is intended only to notify stakeholders and prospective applicants about

USAID’s planned investments in this area, and to describe the general scope of the Agricultural

Biotechnology Program. New activities that address program priorities will be developed and awarded under subsequent, funded Addenda.

a. Program Purpose and Theory of Change

The overarching purpose of the Feed the Future Agricultural Biotechnology for Food Security

Program is to enable developing-country partners to apply agricultural biotechnology to advance global food security, in support of the strategic and cross-cutting objectives of the

GFSS. To fulfill this purpose, USAID’s Agricultural Biotechnology Program aims to help partner countries and regions that choose to apply these technologies to meet two overarching conditions:

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1. Partner countries have the capacity to advance agricultural biotechnology products through the product life cycle.

The product life cycle is the standardized process that every product undergoes as it matures, from inception through disposal. In order for an agricultural biotechnology product to successfully advance through its life cycle, relevant organizations within the partner country must develop, test, obtain regulatory approval for, market, scale, trade, and steward the product. Executing each progressive phase in the product life cycle requires different capacities, and all steps must be completed to ensure success; typically, multiple organizations must coordinate over the product life cycle to ensure that a given product matures through the various phases and achieves development impact. In order to sustainably build this full set of capacities and institutional relationships, USAID aims to support a portfolio of agricultural biotechnology product development activities that, cumulatively, span the full product life cycle in partner countries. In addition to these agricultural biotechnology products driving specific, project-level food security outputs, outcomes and impacts, program activities must strengthen partners’ underlying capacity to sustainably apply agricultural biotechnology as a tool to address local objectives and future challenges.

2. Partner countries have an enabling environment that supports the responsible application of agricultural biotechnology products.

The agricultural biotechnology enabling environment comprises all of the informal and formal norms, traditions, customs, laws, regulations, policies, trade agreements, and infrastructure that must be in place in order for the products of agricultural biotechnology to be successfully developed, disseminated, and adopted. Though individual R&D projects build targeted capacities within the enabling environment, addressing many of these systemic challenges typically transcends the scope of individual product-development efforts, and requires additional, specialized expertise and approaches. USAID will therefore support complementary programming to address critical constraints in partner countries’ biotechnology enabling environment.

The above approach can be framed as a Theory of Change for USAID’s Feed the Future

Agricultural Biotechnology Program: By supporting a portfolio of agricultural biotechnology product-development activities that allow partners to gain hands-on experience with the full product life cycle, complemented by activities that cultivate the local enabling environment for agricultural biotechnology, USAID’s Agricultural Biotechnology for Food Security Program will progressively build partner capacity to responsibly apply agricultural biotechnology as a tool to achieve food security―ultimately driving development gains consistent with the GFSS, and advancing USAID’s partners on their journey to self-reliance.

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As for any international development program, the above Theory of Change for USAID’s

Agricultural Biotechnology Program rests upon several assumptions. Contextual assumptions include that partner countries retain sufficient social and political stability to successfully implement development programming throughout the programmatic period, and that the broader global trade and regulatory climate supports partner countries’ aspirations to apply agricultural biotechnology.

This Theory of Change also makes a key programmatic assumption. Successful deployment of any agricultural product (whether conventional or biotechnological) relies on the basic, underlying functionality of agricultural innovation and market systems. However, USAID’s

Agricultural Biotechnology Program generally limits its scope to activities, capacities and enabling-environment considerations directly relevant to agricultural biotechnology products.

This Theory of Change therefore assumes that activities under USAID’s Agricultural

Biotechnology Program will actively leverage, align, and coordinate with complementary research, value-chain and market-system investments made by USAID and other development partners in partner countries―and that those complementary activities will help build sufficient local innovation- and market-system capacity to potentiate the more targeted agricultural biotechnology activities and interventions supported under this Program.

b. Technical Objectives

In order to accomplish the purpose articulated in the above Theory of Change, the Feed the

Future Agricultural Biotechnology for Food Security Program aims to achieve the following two technical objectives. (Note that although cumulatively USAID’s Agricultural Biotechnology

Program should address both objectives, USAID does not anticipate that every award supported under the program will emphasize all objectives to an equal extent; individual projects or activities may address a subset of these objectives or key programmatic elements, as specified in the relevant Addendum.)

1. Technical Objective 1: Develop and take to scale agricultural biotechnology products that advance GFSS objectives―in the process building the capacity of local innovation-and market-system actors to support biotechnology products throughout their life cycle.

The product life cycle is the standardized process that every product undergoes as it matures, from inception through disposal. Though details vary depending on the product, the life cycle of an agricultural biotechnology product is typically conceptualized in successive phases such as Discovery, Development, Regulatory Approval, Production, Distribution, Utilization, and Discontinuation (Annex 1). Though USAID investment at the early

“Discovery” phase will be minimal, the Agricultural Biotechnology for Food Security

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Program may support activities operating across this full product life cycle―potentially ranging from research and development (R&D) to dissemination of finished agricultural biotechnology products at scale in partner countries.

Since individual USAID awards typically only extend 3-5 years at a time (in contrast to biotech product development timelines, which can require 15 years or more), programming supported under Objective 1 will likely comprise a portfolio of activities operating at different phases of their respective product life-cycles. Note that while sustained support for a given award is never guaranteed, USAID has historically provided product developers with opportunities for performance-based award extensions and/or opportunities to re-compete for continued support at the end of an award phase. Such approaches have enabled USAID to provide sufficiently long-term support to allow the progressive development, deregulation, and scaling of high-potential products, while building accompanying partner capacity along the way.

Given the long development timelines and multiple successive phases of USAID investment typically required to develop agricultural biotechnology products, compounded by the regulatory and trade complexities often involved in bringing biotech products to market, a particularly robust approach is required to successfully design and manage product-development activities. A product life-cycle approach provides an effective framework for such activities.

By encouraging long-term strategic planning, a life-cycle approach ensures that sufficient consideration is given to relevant technical and operational functions throughout each phase of development in anticipation of longer-term implementation needs―for example, addressing not only technical research milestones, but also considerations such as local partner and stakeholder engagement and communications; legal and licensing concerns;

regulatory affairs and compliance; and product marketing, even during early phases of the product life cycle. In particular, a product life cycle approach emphasizes establishment of appropriate phase gates―defined decision points that govern whether and when a product progresses from one phase of development to the next―to…