Biological control and the Nagoya Protocol on access ...

Biocontrol Science and Technology

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Biological control and the Nagoya Protocol on access and benefit sharing – a case of effective due diligence David Smith, Hariet Hinz, Joseph Mulema, Philip Weyl & Matthew J. Ryan To cite this article: David Smith, Hariet Hinz, Joseph Mulema, Philip Weyl & Matthew J. Ryan (2018): Biological control and the Nagoya Protocol on access and benefit sharing – a case of effective due diligence, Biocontrol Science and Technology, DOI: 10.1080/09583157.2018.1460317 To link to this article: https://doi.org/10.1080/09583157.2018.1460317

© 2018 CABI.

Published online: 09 Apr 2018.

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BIOCONTROL SCIENCE AND TECHNOLOGY, 2018 https://doi.org/10.1080/09583157.2018.1460317

REVIEW ARTICLE

Biological control and the Nagoya Protocol on access and benefit sharing – a case of effective due diligence David Smith a, Hariet Hinz Matthew J. Ryan a a

b

, Joseph Mulema

c

, Philip Weylb and

CABI, Egham Surrey, UK; bCABI, Delémont, Switzerland; cCABI, Nairobi, Kenya ABSTRACT

ARTICLE HISTORY

Biological control agents must be collected and utilised in compliance with the Nagoya Protocol on Access and Benefit Sharing (ABS) which is being implemented independently by each country that is signatory to the Protocol. By March 2018, 50 countries had legislation in place with an additional 54 designing their Legislative, Administrative or Policy Measures having become Party to the Protocol. Apart from the problem of dealing with the many different mechanisms countries are putting in place, it is often difficult to find relevant information on the ABS Clearing House and to access and receive appropriate responses from the National Focal Points or Competent National Authorities. We feel that a lot of time is lost on both sides (National authorities and scientists seeking information), and the process would benefit from streamlining. Also, open questions remain, such as how to deal with the generation digital sequence information and what specific activities are considered utilisation, especially for biological control. CABI has pro-actively developed an ABS policy and best practices for its staff to try and comply with the Nagoya Protocol. In addition, CABI has started negotiations with several provider countries, beginning with its member countries, to have its ABS policy and best practices recognised, considering the non-monetary benefits typically associated with biological control. The Nagoya Protocol was born out of the necessity to guarantee the fair and equitable sharing of benefits arising from the utilisation of genetic resources. However, it should not hinder the development of best practice solutions to protect exactly these genetic resources from threats like invasive species. It is important that research and development that addresses global societal challenges are not impeded and that science and its output are recognised as a way to preserve and use genetic resources in an equitable way.

Received 29 March 2018 Accepted 29 March 2018 KEYWORDS

Microorganisms; Nagoya Protocol; Access and Benefit Sharing; regulation; best practice; biocontrol

1. Introduction The Convention on Biological Diversity (CBD) (https://www.cbd.int/) entered into force on 29 December 1993 with three main objectives: 1. The conservation of biological diversity CONTACT David Smith

[email protected]

CABI, Bakeham Lane, Egham Surrey TW20 9TY, UK

© 2018 CABI. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial- NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.

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2. The sustainable use of the components of biological diversity 3. The fair and equitable sharing of the benefits arising out of the utilisation of genetic resources As a result, countries claimed sovereign rights over their genetic resources to facilitate the conservation of their biodiversity. The goal was to ensure that biodiversity was conserved and sustainably used for the benefit of humankind and it was not intended to restrict access to it. The equitable sharing of benefits was intended to help ensure conservation and use was made sustainable. The Conference of the ‘Parties’, the governing body of the CBD, decided that there was a need to develop guidelines and pursue other approaches to assist the ‘Parties’ with the implementation of the access and benefit-sharing (ABS) provisions of the Convention. Initially, the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilisation were adopted in 2002. The aim of these guidelines was to assist the ‘Parties’ to establish administrative, legislative or policy measures when negotiating contractual arrangements for access to genetic resources and benefit sharing. Over the period of 2005 to 2010, an international regime on ABS was negotiated to formalise the process. The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation to the Convention on Biological Diversity was adopted at the tenth meeting of the Conference of the Parties, in Nagoya, Japan on 29 October 2010 (https://www.cbd.int/abs/). As a result of both the CBD and the Nagoya Protocol, users of genetic resources have responsibilities in the fair and equitable sharing of benefits arising from their use. Nations were invited to ratify the Nagoya Protocol and implement regulation to enforce it. In Europe, the EU Regulation on ABS No 511/2014 http://eur-lex.europa.eu/legal-content/ EN/TXT/?uri=CELEX:32014R0511 was enacted simultaneously. This was followed by European nations implementing the regulation, striking a balance between regulatory control and due diligence. Each country signatory to the CBD and the Nagoya Protocol is currently implementing its own controls, ensuring compliance with its requirements. In March 2018, there were 104 Parties to the Protocol with 50 countries publishing regulation on the ABS Clearing House (ABSCH) https://absch.cbd.int/. Scientists and organisations must align their practices in the conservation and use of genetic resources (GR) to comply globally with the Nagoya Protocol on ABS requirements, as well as working within the spirit of the CBD. This not only entails abiding by the rules and regulations of the country in which the work is done but also with the providing country where the material originated. The requirements can be quite different and it is critical that these are fully understood before collecting material for use. Countries controlling access to their genetic resources typically require Prior Informed Consent (PIC) and negotiation of Mutually Agreed Terms (MAT) for access and the subsequent use of the resources. The Nagoya Protocol was designed to: .

.

prevent the utilisation of genetic resources, or associated traditional knowledge, which was not accessed in accordance with the national ABS legislation or regulatory requirements of a Party to the Nagoya Protocol. support the effective implementation of benefit-sharing commitments set out in MAT between providers and users.

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improve the conditions for legal certainty in connection with the utilisation of genetic resources and traditional knowledge.

Biological control involves the release of living organisms into the environment for the control of pests or weeds that have negative impacts on indigenous biodiversity, ecosystem services and/or livelihoods. There are two main approaches, the first, known as classical biological control, is the introduction of a biological control agent from the pests region of origin to control it in the area where it has invaded. Typically once introduced, the agent should become established, reproduce and spread with the ultimate goal of a self-sustaining effect on the pest population. This work is usually done by universities and/or governmental researchers and results in a ‘common good’ (the biocontrol agent), available to everybody for free. The second approach, augmentative biological control, involves the mass release of either native or exotic biological control agents against a particular pest. This approach will in most cases – at least in the developed world – result in a product and may eventually generate a modest profit. Both approaches of biological control may require the utilisation of genetic resources to conduct extensive risk analysis studies to ensure the environmental safety of the released biocontrol agent. The current paper aims to highlight the difficulties, especially for researchers in biological control, to comply with the requirements of the Nagoya Protocol and how CABI, as an international organisation has dealt with these challenges. In particular, we will present CABI’s policy on ABS and its best practices, then give an overview of CABI’s experience of negotiating with genetic resource provider countries and end with specific recommendations for compliance, specifically for researchers in biological control.

2. Difficulties complying with the Nagoya Protocol The Protocol is impacting on research, requiring the researcher to seek permission to access genetic resources in advance of collection and thus at the project planning stage. They must negotiate mutually agreed benefits that will be shared from the intended use. Smith, Lyal, da Silva, and Jackson (2017) describe how this impacts on microbiology and provide a decision tree to help scientists comply with ABS requirements. However, many signatories to the Protocol are only just putting in place specific measures to implement the Nagoya Protocol. Information is often difficult to access and not always available on the ABSCH, making it necessary to contact the appropriate National Focal Point (NFP) or a Competent National Authority (CNA). Indeed on occasion scientists have obtained clearance for use of a genetic resource only to find they were dealing with a government department not authorised to provide relevant permissions. We believe that more centralised help could be offered. Researchers who wish to access a country’s genetic resource are asking the same questions of the national authorities regarding the processes for compliant access which are most often not transparent and easily accessible. A set of answers to frequently asked questions specifically on the details of the process for each country are available (e.g. see http://wiki.ggbn.org/ggbn/ABS_Fact_Sheet_and_Answers_to_Frequently_Asked_ Questions) to get an understanding of terminology and a general understanding of the

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Nagoya Protocol but not necessarily referring to what an individual needs to do to be compliant. Often the details are hidden away in implementing acts and in languages that prevent a general and easy understanding. As researchers, or indeed research organisations gather such information through experience, it is critical that this is shared, to reduce the amount of time and money that are invested in discovering the process and negotiation required. This may consequently be lost from the research itself or if the process is too restrictive to prevent the research from being undertaken. Access to some countries has become so difficult or impossible that it is forcing researchers to source genetic resources from countries with working legislation for ABS in place, accessing genetic resources through registered collections or simply using indigenous natural enemies. This does not only hinder the development of the best biological control solution, but in the long term also isolates the respective provider countries to obtain biological control solutions for their agricultural and environmental problems. In addition to the specific operational level requirements, there are still unresolved global issues which are being addressed. The Conference of the Parties (COP-MOP) has been carrying out an evaluation of the effectiveness of the Nagoya Protocol initiated in October 2017. COP issued a notification: Contribution to the first Assessment and Review of the Effectiveness of the Nagoya Protocol Ref.: SCBD/SPS/DC/VN/BG/JR/ 86908 https://www.cbd.int/kb/record/notification/2679?RecordType=notification& Subject=ABS. The purpose of this notification was to collect information on: (a) the use of model contractual clauses, codes of conduct, guidelines, best practices and/or standards as well as indigenous peoples and local communities’ customary laws, community protocols and procedures; and (b) the implementation and operation of the ABSCH. CABI responded with the concerns detailed above, but the outcome of this evaluation has yet to be determined.

3. CABI’s initiative to comply with the Nagoya Protocol CABI is an international not-for-profit organisation that uses genetic resources in its mission to improve people’s lives by providing information and applying scientific expertise to solve problems in agriculture and the environment (www.cabi.org). This is achieved through knowledge sharing and the application of scientific research to improve global food security and safeguard the environment. In doing so, CABI accesses genetic resources and undertakes sampling/collection of genetic resources, while delivering benefits to farmers around the world through its mission-driven activities by helping them grow more and lose less of what they produce. CABI’s aims in the use of biological and genetic resources of plant, animal or microbial origin, are to engender trust, to facilitate science and to ensure that benefits are shared. CABI has prepared and is implementing policy (Box 1) on ABS and works with its partners and various relevant communities to introduce best practice in compliance with requirements of stakeholder countries. CABI has introduced a generic Material Transfer Agreement (MTA) to ensure recipients of genetic resources from CABI are aware of their responsibilities in the use of genetic resources and in respect of benefit-sharing commitments made. CABI is in the process of negotiating access with all provider countries of genetic resources that are used in the course of CABI’s work. These documents are shared

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with partners but as yet have not been made public. CABI is aware of several community model contractual clauses, codes of conduct, guidelines, best practices and/or standards in relation to ABS which it takes into consideration; for example: .

European Culture Collections’ Organisation (ECCO) core MTA https://www.eccosite. org/ecco-core-mta/ this is currently under review Microbial Resources Research Infrastructure (MIRRI) ABS Manual https://zenodo.org/ record/284881 Global Genome Biodiversity Network (GGBCN) ABS Guidance, Best Practice for ABS: http://www.ggbn.org/docs/ABS_Guidance/GGBN%20Guidance%20_Best_Practice_ June_2015-Final.pdf International Organisation for Biological Control of Noxious Animals and Plants (IOBC) Commission on Biological Control and ABS http://www.iobc-global.org/ global_comm_bc_access_benefit_sharing.html Consortium of European Taxonomic Facilities (CETAF) Code of Conduct and Best practices https://cetaf.org/sites/default/files/final_cetaf_abs_coc.pdf

. .

.

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Box 1. An overview of CABI ABS policy. CABI ABS policy was accepted in principle by representatives of its 48 Member Countries at its 19th Review Conference held in the UK in July 2016, on the condition that CABI would seek appropriate National agreements. CABI makes a commitment in this policy to use genetic resources in its mission. CABI undertakes that it: . will deliver the benefits (described below) to its member countries but requires approval from its member countries to allow its scientists to access the genetic resources (mainly invertebrates, insects, microorganisms) it needs in its work (outlined below) without having to apply for individual approval each time such access is needed to reduce administrative burden for both CABI and the provider country. Access excludes resources covered by the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) or other overriding international conventions and will be compliant with National Law. . will not exploit genetic resources for monetary gain without involving the provider country; direct contact with the NFP will be made and for those countries that have no access procedures in place and do not want arrangements, they will not be further contacted. . will be transparent in all its uses, reporting at least annually what materials CABI holds for each country and what use they are being put to. In its work, CABI accesses genetic resources and undertakes sampling and collection of biological materials for: . .

. . . . .

diagnosis and identification of pests and diseases, so that appropriate management recommendations can be made; rapid identification of newly introduced alien species to facilitate containment and management; CABI is aware of sensitive issues around finding new pests, invasive species, new occurrences of pathogens and will work with national authorities on such issues; studies to assess impact of land-use and climate change on biodiversity and ecosystems services which often involves finding species new to science; developing microbial solutions to improve health and nutrition security; combatting threats to livelihoods, agriculture and the environment from pests and diseases; developing biological control agents for the management of invasive species, reduction of crop losses and minimisation of unnecessary pesticide use; and increasing and improving access to agricultural and environmental scientific knowledge.

When accessing or transferring biological and genetic resources CABI seeks to provide recipients with legal clarity in use. CABI will perform due diligence regarding access and benefit sharing in all its activities involving those resources. Commercial opportunities/products rarely develop from this work but if this is the intention or the potential arises during CABI’s research, CABI will return to the provider country to negotiate new use and agree terms on benefit sharing, if this is not already addressed in MAT. Member countries agreed at CABI’s 13th Review Conference in 1996 that CABI’s obligations for Access and Benefit Sharing in accordance with the Convention on Biological Diversity is met by CABI devoting any proceeds from

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commercialisation of genetic resources collected from its member countries to support the ‘not-for-profit’ missiondriven activities of the organisation (Anon, 1996). In addition, CABI’s activities result in significant non-monetary benefits or contributions to the local economy for its member countries, including: . . . . . .

sharing of research and development results relevant to country priority needs; collaboration in education, training, scientific research, development programmes and individual training related to use of genetic resources; joint authorship of publications and joint ownership of intellectual property rights; access to ex situ facilities, resources and databases; transfer of scientific information, knowledge and technology; and institutional capacity development to help build or maintain local collections

In light of the Nagoya Protocol, CABI wishes to ensure it complies with any additional measures which may be needed. CABI will negotiate an agreement with each Member and/or Provider Country to ensure its ABS policy and practices are compliant with national law and ABS requirements. This agreement could take the form of a Memorandum of Understanding or other preferred document. In providing samples to third parties in the course of CABI’s work or service provision, CABI does not assign rights for commercial applications and requires the recipient to comply with the terms and conditions of the provider country through a Material Transfer Agreement (MTA) containing reference to the original MAT.

The International Organization for Biological and Integrated Control (IOBC), Commission on Biological Control and Access and Benefit Sharing was set up in October 2008. Amongst its roles were to documenting the potential for negative consequences of adopting strict regulations about ABS of BCAs, transfer knowledge on ABS and to promote the development and application of new international conventions on biological control and ABS which respect the CBD. The group reported to FAO in 2009 The Use and Exchange of Biological Control Agents for Food and Agriculture (http://www.iobc-global. org/download/658IOBCreportABSforFAO16Oct2009OfficialFAOversion.pdf). Work has led on to produce best practices and guidance with the intent that biological control will be facilitated and not impeded, as new pest challenges arise. A number of joint efforts are underway to facilitate the sharing of information on best practices for compliance. An initiative of the United States Culture Collections Network (USCCN – www.usccn.org/) brought stakeholders together to discuss how USA researchers should address the Nagoya Protocol, despite the USA not being party to it or the CBD. Common issues were discussed and issues around awareness and sharing information actioned (Boundy-Mills, Smith, McCluskey, Greene, & Duke, 2017; McCluskey et al., 2017). Nations are setting different criteria that trigger benefit sharing and also what these benefits are. There is a prerequisite need to reduce administrative burden as much as possible. There are potentially 198 parties to the Nagoya Protocol, each with their own ABS requirements, the practical guidance and information necessary for compliance should not be beyond COP and it would save a tremendous amount of time and duplicated effort.

4. CABI’s experience of negotiation with genetic resource provider countries In the process of negotiating access and use of microorganisms and invertebrates for CABI’s specific research uses, CABI has contacted 28 countries; 10 have said (all European countries) that they have no current access controls and they were happy for CABI to collect and use as detailed in our policy and best practice procedures. One country, Ghana, has signed a Memorandum of Understanding based upon the implementation


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of CABI Policy, on the other hand, one country responded that ‘we have law, follow it’. Negotiations continue with 12 countries; unfortunately, CABI has failed to establish communication with four of them. The reasons for this are mainly related to the fact that countries are still trying to decide what they want or are currently drafting regulation. CABI would like to be able to negotiate the terms and conditions once for the typical uses CABI puts the genetic resources to in return for a set of mutually agreed benefits. This would reduce administrative burden by focussing on those rare events where new uses are considered or commercial use is the goal. CABI has had some success in implementing its policy, with several common factors in responses received and some presenting difficulties in their implementation: .

Work through in-country partners; for CABI, this is relatively easy as we already work through country partnerships but for many it is not easy to find appropriate partners Deposit samples in-country; many countries do not have the collections nor the capacity; however, CABI maintains a central genetic resource collection, maintained on behalf of its member countries Deliver CABI benefits; the appropriate and equitable level of benefits is not consistent between countries Implement best practices in a transparent way; monitoring and reporting mechanisms are often quite burdensome (Box 2) Obey the law – this is obvious but it is not always easily accessible (either physically or in a language that individuals can understand). Further, understand what the mechanisms are, and practical steps that must be followed; these are rarely defined in the regulation itself

.

. . .

Box 2. Overview of CABI best practice. Consistent with Article 20 in the Nagoya Protocol, CABI has developed and adopted Best Practice for Access and Benefit Sharing. CABI staff understand their rights and responsibilities which are defined under the national laws implementing appropriate treaties and relationships with Providing Countries of genetic resources and will abide by relevant laws and regulations in their work; ensure that genetic resources is obtained with appropriate legal certainty; and that CABI shares appropriate benefits for access with the provider country of the genetic resources. Genetic resources are acquired in two main ways: collection from in the field (in situ) and from ex situ sources such as collaborating scientists, institutions or collections in a Providing Country. The CABI Guidance Applicable to all CABI staff in all work with genetic resources; appropriate compliant procedures to implement this guidance will be integral to day-to-day operations; materials can only be used by non-CABI staff in accordance with the agreed provider terms and subject to appropriate consortium agreements or contracts. Collecting genetic resources for use . . . .

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All CABI dealings with genetic resources will comply with ABS requirements At project concept stage, check all relevant requirements for approvals needed At project, study or visit proposal stage ascertain whether the provider country is a Party to the Nagoya Protocol and also CBD Check the ABS measures of the country being visited and ensure correct protocol is followed; via www.cbd.int for general ABS measures under the CBD and https://absch.cbd.int/ for measures implemented under the Nagoya Protocol. If possible, acquire Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT) with an Internationally Recognised Certificate of Compliance (IRCC) before submitting project proposals. Where time does not allow this or where the process is unclear at least make a statement in the project application, that is, will be secured before work beginsAcquire PIC and MAT before collecting and agree MTA (Material Transfer Agreement) before exporting

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. . .

. .

. . . .

Work with countries to help establish in-country collections or designated/approved collections for duplicate repositories If acquiring strains from trusted collections follow requirements in line with the country’s regulations Where there is no national legislation in place ○ Work with the National Focal Point to establish what procedure should be followed. ○ If there is no National Focal Point, work with an appropriate Ministry and/or government agency to openly address the ABS issues. ○ CABI will provide staff with MAT agreements based on good practice and encourage their use where practical. Where national legislation does not regulate access to the genetic resources that CABI wishes to access, then CABI will still document what we are doing for future accountability. Staff should be aware that other legislation and international agreements are relevant for access to and export of genetic resources, e.g. CITES, contract or property law, collecting in protected areas, phytosanitary requirements, airline regulations, etc., but these are not addressed here. Check that intended use of genetic resources accessed falls within the scope of CABI’s work outlined above (Box 1) If it is the intention to take a product to market from the beginning or there is a serendipitous discovery of a new use, access for this purpose must be negotiated before the project starts or when the new use is discovered All projects should work with a local partner unless agreed otherwise and at least the relevant CABI Regional Centre or CABI Country Office Notify the relevant Regional Centre or CABI Country Office of planned collection trips; each centre will post a list of intended country projects to facilitate transparency

CABI is seeking open access under standard MAT accepting any specific national or international measures and requirements that may be in place; until this is in place use the CABI policy on ABS as a basis to negotiate PIC for access with MAT based on the benefits CABI offers in this document .

. . . . . . . .

CABI will consider placing its collections on the EU-registered collections list and comply with the requirements when they have been finally agreed. The EU-registered collection list is a mechanism to enable users (academic and industrial, etc.) to undertake ‘due diligence’ in sourcing organisms for their use. Register all collections and genetic resources with CABI providing details of where collected, permit and other legal agreements, where the samples are held and their intended use All CABI staff handling the genetic resources must add information to the database or record system where the samples are, who in CABI is handling them and what is being done with them CABI will introduce reporting mechanisms back to National Authorities of provider countries and meet requirements for the ABSCH Deposit samples of materials to be utilised in CABI collections If there is a change in the use specified in the MAT, negotiate change of use with the National Authority of provider country Record generated data Information on genetic resource use and benefits shared is to be reported to the country of origin, in line with MAT Transfers to third parties is not permitted unless specifically stated in the MAT

Receiving genetic resources from collaborators, collections or other providers .

Ensure the materials have been collected in compliance by asking for evidence, e.g. the IRCC, ABS Clearing House UID, copy of PIC and MAT

Supplying genetic material outside CABI .

Materials will only be supplied outside CABI if the MAT allows and only under an MTA laying down all conditions agreed in the MAT

Monitoring sharing of benefits .

Best practices outlined above involve sample tracking through CABI, which enables monitoring of the genetic resource use and enable timely and appropriate reporting to provider countries

Provision of country reports to include: . . .

lists of genetic resources accessed and their use; relevant research and development results; and reports on sharing the benefits via partnerships, access and outcomes from CABI work.

Include Provider Country in work programmes . .

collaboration and cooperation in scientific research and development programmes, including joint authorship of publications following good scientific practice; collaboration and cooperation in education and training;


. . . . .

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knowledge and technology transfer; institutional capacity-building; training related to genetic resources, e.g. supporting post graduate studies leading to legacy capacity development and formal training courses. CABI where possible to support establishment of ex situ facilities including policies and legislative development Support in projects developing best practices

Provision of access to . . .

scientific information; ex situ facilities and databases; joint ownership of relevant intellectual property rights.

Enforcement and compliance CABI will monitor access and use and ensure compliance with provider country requirements; it will be transparent in all its activities, facilitate audits of processes and report annually or as required on all collection and use activities, including provider country and use. CABI will ensure it has records of all genetic resources accessed and used.

An issue that is gaining significant attention concerns the debate on whether access to Digital Sequence Information (DSI) should be treated in the same way as accessing the genetic resource or material (organism) itself (https://www.cbd.int/abs/dsi-gr. shtml). It is obvious they are not the same thing, as you are able to do more with the organism than you can with a partial sequence or even an entire genome. 16S ribosomal DNA for bacteria, and similarly ITS for eukaryotes, have been the basis of modern molecular taxonomy and in the future, whole genome sequencing will impact even more. The benefits of such genome datasets are likely to be much larger once the analysis is at the same speed as the generation of the data, especially if genetic information gives rises to novel intellectual property resulting in financial gain. However, generating and publishing sequence data are considered by many to be descriptive information and therefore not ‘utilisation’ which would accordingly mean that it is out of regulatory scope. Publishing the sequence as electronic data should be considered an act of benefit sharing. The EU and countries have submitted an opinion on this topic and it continues to be important that scientists contribute to help reach a practical and implementable solution. DSI needs to be freely shared in the public domain to help address the taxonomic impediment that the CBD recognises and to meet the needs of agriculture and science.

5. The EU perspective The EU Regulation (no. 511/2014) on ABS compliance does not address access to genetic resources. Instead, this is left to the individual states each able to take its own approach with France and Spain electing to control access whilst the UK and others opting not to put access controls in place. The EU Regulation applies to genetic resources: a) from countries that exercise sovereign rights b) when countries have established applicable access measures and have ratified the Nagoya Protocol c) that were accessed after 12 October 2014 [Or if later the date of enactment of national legislation] d) that are not already governed by specialised international instruments

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Researchers must ask key questions to understand if they need to take action in order to comply. Where does the material originate from? Does the country control access? When were the genetic resources collected? and are they in scope? The EU regulation is applicable when conducting research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology. Information on country requirements can be found at the ABSCH https://absch.cbd.int/. Exactly what uses require benefit sharing is still under discussion and differs from country to country. Some actions are considered simply observations and do not trigger the Nagoya Protocol, e.g. identification/taxonomy but this depends on the provider country. Due diligence requires confirmation of country requirement often needing a consultation with country National Focal Points or Competent National Authorities (Beckett, 2017). Countries controlling access require the collector and user to negotiate MAT having sought PIC to the regulator. Checkpoints are being introduced in Europe due diligence declarations are needed when: . .

Securing funding for research and development on genetic resources A product goes to market

Guidance has been issued to facilitate compliance: http://eur-lex.europa.eu/legal-content/ EN/TXT/?uri = CELEX%3A52016XC0827%2801%29 and sector-specific guidance is being drafted for, e.g. Biotechnology; Food and Beverage; Biocontrol and Biostimulants; Cosmetics; Researchers; Culture Collections, etc. In the UK, due diligence declarations can be submitted electronically and information and guidance given through the UK Regulatory Delivery Department for Business, Energy and Industrial Strategy (BEIS) https://www.gov.uk/guidance/abs. For requirements in other countries, referral should be made via National Focal Points and Competent National Authorities https://absch.cbd.int/countries. When information is not available, national stakeholder groups should be approached and individuals should ensure they contribute to implementing practical compliance procedures. The last thing any researcher should do is spoil research relationships with other countries by not following procedures.

6. Specific recommendations for compliance in biocontrol There has been extensive work on establishing guidance for compliance with ABS requirements in Biocontrol (Cock et al., 2010; IOBC, 2009; Mason et al., 2018) where research groups and the International Organisation for Biological and Integrated Control have defined general practical and implementable guidance. Efforts are also being made by the EU who has drafted guidance on Biocontrol and biostimulants with compliance with the EU Regulation on ABS in mind. Table 1 shows a breakdown of biocontrol research activities and whether they are considered in or out of scope of the regulation in the EU guidance. Although the table is based on a draft version, it is clear that elements of the research do trigger the regulation and require benefits to be shared. A key problem is that countries outside of Europe express different opinions on these elements, some, for example, Brazil, only considers benefit sharing is triggered when a product is placed on the market (Smith et al., 2017). It is the opinion of the authors that the Biocontrol


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Table 1. Biocontrol and biostimulants guidance on the elements of biocontrol research and development in compliance with the EU Regulation No 511/2014 on ABS. Activity Acquisition of genetic resources Storage, rearing and multiplication Identification, characterisation, evaluation and selection Taxonomic identification and/or re-identification of organisms Assessment of the effectiveness of organisms for use as biological control agent Assessment of the host specificity of biological control organisms Crossing and/or conscious and targeted selection within populations of organisms Molecular characterisation, phenotypic comparison between organisms in a collection Research to maintain and/or increase the effectiveness of organisms as biological control agent or biostimulant by strain selection and/or hybridisation Mutation to increase the effectiveness of organisms as biological control agent or biostimulant by creation and/or selection of mutants or to produce sterile insects Preparation of derivatives including use of products imported as commodities Breeding and selection to obtain botanicals/metabolites/molecules/ mixtures Identification and evaluation of derivatives Physico-chemical characterisation of substances for use as biological control agent Isolation and identification of semiochemicals or other naturally occurring molecules or metabolites in genetic resources, and studying their biochemical activities Evaluation of mode of action of active substances as a biological control agent Synthesis of derivatives Product formulation and use Marketing and sales

In or out of scope of the EU Regulation Out of scope Out of scope Out of scope Out of scope Out of scope Out of scope Inside scope Inside scope Inside scope Inside scope Out of scope Inside scope Out of scope Inside scope Inside scope Out of scope Out of scope Out of scope

Community should come together to ask COP to consider the use of genetic resources for classical biocontrol as a public good and agree that the benefits that are shared are knowledge based plus facilitated access to biocontrol agents to resolve global solutions to common environmental and biodiversity-related problems. Countries agreeing on such a basis would benefit from know-how and solutions in return for giving access to their resources for such purposes. This meets the intention of the CBD and the Nagoya Protocol and the appropriate level of benefit sharing that countries are seeking.

7. Summary Researchers and their research institutions/organisations should be working with countries to establish mechanisms for the sharing of appropriate benefits for uses for the public good and to assure that advancements in science are not prevented. The example provided of the CABI approach will be useful for researchers collecting and utilising genetic resources for biological control and other research activities. Compliance can be achieved but the administrative burden needs to be minimised to allow prioritisation to be given to research. The key issues are: . . . .

Establish best practices and seek their endorsement All scientists should ascertain: When was the material isolated and from where? Use the CBD and ABSCH websites for advice; if not available, contact the Country’s NFP or CNA When materials are subject to legislation, ensure the following is obtained: ○ PIC – Prior Informed Consent ○ MAT – Mutually Agreed Terms must include the specific use you intend ○ MTA – Material Transfer Agreement

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IRCC – Internationally Recognised Certificate of Compliance (where possible) When materials are not (yet) subject to legislation, best practice should be adhered to. Ensure awareness of the provider country requirements for monitoring (checkpoints) and reporting as well as your own. ○

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The future of humankind and the rest of Earth’s biodiversity depend upon our research efforts generating solutions to the global challenges. The Nagoya Protocol has the aim to share the benefits of our research but we must not let it prevent researchers, research organisations and biocontrol industry to access the raw materials that could give us the best solutions. These include antimicrobials to reduce deaths from diseases, higher food yields and prevention of loss of crops to feed more people and the knowledge to protect biodiversity and the environment on which we depend.

Acknowledgements The authors thank CABI colleagues for their work in our Regional Centres in contacting and negotiating CABI ABS policy in their regions in particular Babar Bajwa (Pakistan); Victor Clottey (Ghana); Yelitza Colmenarez (Brazil); Noah Phiri (Zambia); Gopi Ramasamy (India); Naitram (Bob) Ramnanan (Trinidad & Tobago); Abdul Rehman (Pakistan); Richard Shaw (UK); Sivapragasam (Malaysia); Feng Zhang China) and the additional contributors to CABI Policy, Trevor Nichols and Matthew Cock (UK) and Uli Kuhlman (Switzerland).

Disclosure statement No potential conflict of interest was reported by the authors.

Funding This work received the support of the CABI Development Fund (with contributions from the UK’s Department for International Development, the Australian Centre for International Agricultural Research and others). CABI is an international intergovernmental organisation, and we gratefully acknowledge the core financial support from our member countries (and lead agencies) including the United Kingdom (Department for International Development), China (Chinese Ministry of Agriculture), Australia (Australian Centre for International Agricultural Research), Canada (Agriculture and Agri-Food Canada), Netherlands (Directorate-General for International Cooperation), and Switzerland (Swiss Agency for Development and Cooperation). See https://www.cabi.org/ about-cabi/who-we-work-with/key-donors/ for full details.

ORCID David Smith http://orcid.org/0000-0003-1821-5141 Hariet Hinz http://orcid.org/0000-0003-2930-6807 Joseph Mulema http://orcid.org/0000-0002-8738-1306 Matthew J. Ryan http://orcid.org/0000-0002-3689-6609

References Anon. (1996). CAB international 13th review conference proceedings. Wallingford: CABI International.


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