Building trust for sustainable access and benefit-sharing of biological control genetic resources: a CABI case study

CABI is a not-for-profit international organization with the mission of improving people’s lives worldwide by solving problems in agriculture and the environment, while engendering trust and facilitating science. As an organisation CABI is both a provider and a user of biological control agents and regularly acting as an intermediary between provider and user countries. As a way of building trust between both sides, access and benefit sharing (ABS) policy and ABS best practices developed around the principles of the Nagoya protocol should be publicly accessible. CABI aims to facilitate compliance with national legislation on ABS through its best practices for the countries in which we work and those that we provide genetic resources. CABI adopted the position to share benefits whether the provider country is party to the Nagoya Protocol or not. We use a case study on the biological control of the coffee berry borer (Hypothenemus hampei (Ferrari)) to illustrate the implementation of ABS best practices for the overlap between biological control and ABS. In respect to Digital Sequence Information (DSI) associated with genetic resources CABI contributes to the ongoing global debate and evaluates how this may impact biocontrol research and delivery. The current view is that publishing sequence data is sharing descriptive information and thus delivers benefit-sharing from its generation. However, if DSI is used in a product placed on the market, there is justification for benefit sharing.


Introduction
The Nagoya Protocol (NP) came into force on 12 October 2014 and is the instrument for the implementation of access and benefit sharing (ABS) provisions of the Convention on Biological Diversity (CBD). CABI's mission is to improve people's lives worldwide by solving problems in agriculture and the environment. A key component of this mission is research into the management of invasive species using classical biological control which has a clear overlap with core objectives in the NP and for ABS. Key issues that have arisen regarding the NP include building trust between providers and users of genetic resources, as well as the debate around Digital Sequence Information (DSI) and the benefit-sharing from its generation. In this paper these issues will be discussed based on CABI's experience and response to ABS and illustrated using a case study.
CABI is a not-for-profit international organization owned by its current 49 member countries, established by a United Nations treaty level agreement, where each member country has an equal role in CABI's governance, policies and strategic direction. CABI has a presence in 26 countries and active research centres in 11 member countries. Forty-two of CABI's member countries have responded to the NP, with four being signatories and 38 party to it. Additionally, CABI projects operate currently in over 70 countries, where CABI is both a provider and a user of biological control agents and regularly acts as an intermediary between provider and user countries. CABI continues to work successfully in these countries by ensuring compliance with the NP so that benefits are shared in an open and transparent manner. In agreement with its member countries, benefits are shared through CABIs mission-based objectives (Smith et al. 2021). Benefits shared include: (1) research and development results relevant to country needs; collaboration in education, training, research; (2) development programmes and individual training; (3) joint authorship of publications; (4) joint ownership of intellectual property rights; (5) access to ex situ facilities and databases; (6) transfer of scientific information, knowledge and technology; and (7) institutional capacity-development to help build or maintain local collections (Smith et al. 2021).

Building trust
For transparency and accountability CABI has made its policy on ABS publicly available online under its Environmental Policies (CABI 2018) and has designed an overview of a best practice which has been published open access . CABI shares information on ABS through various platforms including conferences and conference proceedings , publications (Silvestri et al. 2020) and reports (Smith et al. 2021). One current challenge is that each country is responding differently to the NP with many still in the process of developing and implementing respective regulations. To ensure compliance on a country level, CABI has developed ABS best practices for each of its centres that reflect the host country requirements. The best practices developed by CABI's Centre in Switzerland have been officially recognized by the respective Swiss national authority (i.e., the Federal Office for the Environment, FOEN). In Ghana a formal Memorandum of Understanding is in place that codifies CABI country specific ABS best practice. All other CABI centres in Brazil, China, India, Kenya, Malaysia, Pakistan, Trinidad and Tobago, UK and Zambia have countryspecific ABS best practice drafted and are following local regulations as appropriate (Smith et al. 2021). To supplement the publicly available best practices that document CABI's compliance with the NP and ABS, and to ensure broad transparency, CABI has supplemental position statements on specific components of the protocol, including DSI (CBD 2021a).

Digital sequence information
The CBD and its Parties continue to discuss issues around DSI with regard to ABS. During the UN biodiversity conference in December 2022 in Montreal, Canada (COP15), the Kunming-Montreal Global Biodiversity Framework was adopted, which includes a decision on DSI as related to ABS and the NP (CBD 2022). Besides other points, it was agreed to continue to use the term "digital sequence information" without addressing the differences of opinions on its definition and scope and therefore the term remains a place holder. It was also decided to establish a multilateral mechanism, including a global fund for benefit-sharing from the use of DSI. A fair, transparent, inclusive, participatory and time-bound process to further develop and operationalize the mechanism is to be finalized at the conference of the Parties at its sixteenth meeting (COP16). An ad-hoc open-ended working group (OEWG) on benefit-sharing from the use of DSI will undertake the further development of the multilateral mechanism and will make respective recommendations to the COP16. Review of the effectiveness of the multilateral mechanism would be undertaken at COP18. Parties, other governments, indigenous people and local communities and relevant organizations were invited to submit their views on the issues set out in an annex to the decision. Additionally, countries have different positions some believing that DSI is an integral part of the genetic resource and therefore must be subject to benefit sharing whereas others suggest it is out of scope of the NP. Several countries are already including it in their ABS measures whilst others await the outcome of the further discussions at CBD level (see above). AHTEG (2020) report five main country approaches to addressing DSI: (1) addressing DSI only in conjunction with the utilization of the "physical" genetic resource; (2) others include conditions as part of Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT) or the requirement for PIC and MAT to access DSI; (3) some include DSI within the scope of the definition of a genetic resource; (4) some have no access requirements for DSI but require benefit-sharing from its utilization; (5) some countries have other compliance-related measures and other countries seek to promote unrestricted access to and use of DSI and have no domestic measures that regulate access or require benefits.
CABI has taken the view that publishing sequence data is sharing descriptive information and thus delivers benefit-sharing from its generation. As such, generating DSI should be out of the scope of the NP because it already fulfils benefit sharing requirements, but this is not universally accepted. However, CABI believes that if DSI is used in a product placed on the market there is justification for benefit sharing. Adding to the complication of different country approaches, the scope and definition of DSI is still debated (see above). It is important to CABI that country positions are complied with and CABI's position posted on the CBD website (CBD 2021b), reflected below, will adapt to the measures implemented by the provider country.
CABI's rationale for its position is that elements of DSI, for example barcodes, are in every day use for the identification and characterisation of species and populations. On its own an unknown sequence is not of use until it has been compared to known sequences and its content characterised. We believe that the open access to this publicly available data enables sequences from multiple individuals and sources (countries) to be characterised and is critical for the advancement of science. The move to whole genome sequencing will enhance our ability to recognise the yet to be discovered organisms, add to biodiversity inventories and have a similar impact on taxonomy (Fuentes-Pardo and Ruzzante 2017). CABI argues strongly that DSI generated for taxonomic or descriptive purposes needs to be freely shared in the public domain to help address the taxonomic impediment. This is recognised by the CBD and most stakeholders in order that the needs of agriculture and other sciences are met. CABI believes that the generation of DSI and its publishing in globally accessible databases should be considered as part of a country's responsibilities under Article 7 (Identification and Monitoring) and 17 (Exchange of Information) of the CBD (CBD 2016).
It has been clearly demonstrated that there is a need for capacity building as making DSI publicly available does not mean that everyone has the same opportunity to utilise it (CBD 2022). Whatever the outcome of the further decision process following COP15, CABI will adapt this position according to the outcome of the global debate and be guided by its member countries as regulations are formulated.

Case study: biological control of coffee berry borer
An endemic African beetle, the coffee berry borer (CBB) Hypothenemus hampei (Ferrari) (Coleoptera: Curculionidae: Scolytinae) (Le Pelley 1968) was first reported as a coffee pest in 1901 in the Republic of Congo (Fleutiaux 1901). Since then the beetle has expanded its range and continues to take advantage of climate change (Jaramillo et al. 2011). More recently CBB has been detected in Hawaii (2010) (Burbano et al. 2011) and in Puerto Rico (2007) (Marino et al. 2017. Joint efforts between Hawaiian and Puerto Rican growers and institutions in recent years have resulted in improved management of CBB. One of the key low-risk management options is classical biological control through deployment of parasitoids from the area of origin of the pest. In the 1980s, three parasitoids, i.e., Phymasticus coffea LaSalle (Hymenoptera: Eulophidae), Prorops nasuta Waterston (Hymenoptera: Bethylidae) and Cephalanomia stephanoderis Betrem (Hymenoptera: Bethylidae), were collected in Kenya and have to the introduced range been effective in the management of CBB.
CABI was approached by the US Department of Agriculture, Animal and Plant Health Inspection Service (USDA, APHIS) in 2020 to help source additional CBB parasitoids. The objectives of the project are twofold, to secure requisite permits from relevant national and county authorities and to collect and ship parasitoids from Kenya to Hawaii. Under the first objective CABI has led negotiations to obtain PIC and MAT with the providers and users under guidance of the Kenya Wildlife Authority. The providers are the County Governments of Busia, Kisii and Kisumu while the users are CABI, the Centro Nacional de Investigaciones de Café in Colombia, and the Kenya Agricultural and Livestock Research Organization. When the PIC and MAT will be signed, the providers will apply for a research permit from the Kenyan National Commission for Science, Technology and Innovation which permits research work to be undertaken. Acquisition of a research permit along with the PIC and MAT will allow for field collections to be granted by the Kenya Wildlife Authority. When the collections are completed, a Material Transfer Agreement (MTA) will be negotiated by CABI on behalf of the users and by the Kenya Wildlife Authority on behalf of the providers and the Government of Kenya. An export permit and phytosanitary certificate to allow shipment of parasitoids to Hawaii will be issued after agreement and signing of the MTA. This will allow for shipments of parasitoids to Hawaii to take place. Hawaii will then send the parasitoids to Colombia, as needed. Colombia cannot receive the parasitoids directly from Kenya because its country legislation and regulations prohibit direct transfers from Africa. However, in the interim, as the process for the signing is ongoing, a research permit has been granted by the National Commission for Science, Technology and Innovation to undertake field collections of the parasitoids and optimize mass rearing in-country at the Kenya Agricultural and Livestock Research Organisation (KALRO)-CABI (quarantine) facility in Muguga Kenya, leveraging on expertise from Puerto Rico. Once all necessary documents have been obtained (see above), the parasitoids will be exported from Kenya to Hawaii. Hawaii will export some to the Centro Nacional de Investigaciones de Café in Colombia were a large-scale mass rearing effort will be conducted. The organisms will be used in releases in Colombia, and later in Hawaii. In Hawaii, host specificity is complete for P. coffea and the permitting process with federal (USDA-APHIS) and Hawaii Department of Agriculture has been initiated.
The following benefits have been laid out in the PIC: Non-Monetary: (1) Training. During this programme opportunities for further training of users are being conducted.
To date, eight laboratory technicians and Kenyan entomologists have benefitted from acquiring skills to mass rear and maintain the three parasitoids of CBB (P. coffea, P. nasuta and C. stephanoderis), both on CBB and artificial diet for augmentative field release.
(2) Specialized training and exchange program. Specialised training on parasitoid management and use between Kenya and the user countries will be undertaken. Scientists from research institutions will benefit from the capacity in identification, rearing and release of CBB parasitoids. Extension officers will learn about management of CBB using classical biological control, while farmers will be made aware about CBB and its management through classical biological control. For instance, experts from the Center of Excellence in Quarantine and Invasive Species, University of Puerto Rico and the University of Hawaii have visited CABI Kenya and the Counties of Busia, Kisii and Kisumu to provide training on bioecology, mass rearing and raise awareness about conservation biocontrol. Additionally, more than 100 university students have undertaken either learning visits or short-term attachments to the facility to understand how a programme for biological control of CBB could be undertaken. Through such experiences, young Kenyans pick an interest in the concept of biological control that informs their future careers in crop protection. (3) Infrastructure and equipment. Since 1975 CABI constructed a fully equipped quarantine facility at KALRO, Muguga. It consists of seven automated control temperature rooms, three preparation rooms, five greenhouses, a propagation room, an incineration chamber, stores, a library stocked with relevant scientific publications, over ten offices, vehicles, etc. Equipment pro-cured included those required for both pathology and entomological research. These include laminar flows, incubators, autoclaves, humidifiers, ovens, hot plates, water distillers, blenders, dissecting and compound microscopes, etc. The quarantine facility was inspected by the Kenya Standing Technical Committee on Imports and Exports (KSTCIE) and certified as a quarantine facility authorised to handle exotic insects, plants and pathogens. The total cost exceeded US$ 10 million. Renovation and maintenance of the quarantine facility continues to date, and over US$ 100,000 was spent in the facility in 2020. As activities in Kenya are implemented, opportunities for developing other projects will be explored, which may further build the capacity in respect to training and infrastructure of local partners. The CBB project utilizes and maintains two temperature controlled rooms, and subsidizes the running costs for KALRO. (4) Outreach and awareness programmes. The users and providers will participate in the inception and project completion meetings, where the key outputs and outcomes will be presented. The project will develop media assets and policy materials for dissemination to various stakeholders. The programme will utilise print and electronic media (publications, workshops, newsletters, etc.) to raise awareness of various stakeholders including farmers, extensionists, agro-dealers and other intermediaries, scientists, policy makers, etc. Building awareness in CBB affected areas regarding the release of parasitoids will be initiated or enhanced. (5) Building a knowledge and scientific base. The project will enhance the knowledge of providers and users that manage CBB in identification, rearing and release of parasitoids for CBB control.

Monetary:
The monetary benefit arising from intellectual property (IP) commercialization shall include upfront milestones and royalties as determined case by case. Any commercialization, media assets or IP or copyrights associated with the biological material and any associated products will attract 15% royalties to the providers. Communities living adjacent to the project sites and their indigenous knowledge will be considered in the benefit-sharing plan. However, we do not expect any monetary benefit because this project does not comprise the commercialization for CBB parasitoids in Hawaii or Colombia.

Conclusions
In summary, CABI has implemented policy and best practice for compliance with the NP, all of which are publicly available to ensure transparency and accountability. The CBB case illustrates this where CABI-in collaboration with USDA, providers and users-is implementing its best practices and following country specific regulations of ABS to access genetic resources for use in classical biocontrol projects. CABI is committed to investing in negotiations for the access and use of genetic resources, especially those which result in a common good, such as biological control and our network of collaborators and centres around the world help facilitate compliant access. CABI's approach involves putting information, skills and tools into people's hands and in doing so shares the benefits of its work. CABI's member countries guide and influence the work of the organization which is delivered by scientific staff based in its global network of centers. CABI is a partnership organisation bringing together research partners in a critical mass to address global problems. It is addressing ABS in the same way ensuring compliance on the one hand whilst delivering solutions. With many countries still in the process of developing and publishing regulations with regards to the NP, more changes will be anticipated. However, CABI is committed to remaining abreast of these and will adapt as required. It is recommended that all users and providers of genetic resources contribute to the current CBD debate on DSI to ensure we get an appropriate regulatory framework that is both practical yet does not impede innovation and discovery. and publications. CABI is an international intergovernmental organization, and we gratefully acknowledge the core financial support from our member countries and lead agencies, including the UK (DFID), China (Chinese Ministry of Agriculture), Australia (Australian Centre for International Agricultural Research), Canada (Agriculture and Agri-Food Canada), Netherlands (DGIS), and Switzerland (Swiss Agency for Development and Cooperation). See https:// www. cabi. org/ what-we-do/ how-we-work/ cabi-donors-and-partn ers/ for full details.

Declarations
Conflict of interest There are no conflicts of interest to disclose relating to this MS.
Research involving human participants and/or animals No humans or animals were used to produce this MS.

Informed consent No informed consent was required for this MS.
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