International agreements and the plant genetics research community: A guide to practice.

Plant genetic resources (PGR), including collections held in national and international gene banks, provide access to a wide array of genetic diversity and are critical to genomics research, conservation efforts, and applied breeding. Yet, there is a general lack of awareness in the research community about the rules and treaties that govern the use of PGR, about access and benefit sharing obligations contained in international treaties and/or national laws, and about how best to comply with potentially applicable requirements. This article provides a brief history and overview of three key international agreements, namely the Convention on Biological Diversity, the Nagoya Protocol, and the International Treaty on Plant Genetic Resources for Food and Agriculture, which collectively address responsibilities and obligations related to the use of much of the world's PGR. By highlighting the coverage and key considerations of each agreement, the article provides a guide for those who use PGR in plant genetics research to better understand when and how international agreements apply, and-where the rules are unclear-to suggest best practices for compliance with existing agreements.

Biodiscoveries within the Australian plant genus Eremophila based on international and interdisciplinary collaboration: results and perspectives on outstanding ethical dilemmas.

In a cross-continental research initiative, including researchers working in Australia and Denmark, and based on joint external funding by a 3-year grant from the Novo Nordisk Foundation, we have used DNA sequencing, extensive chemical profiling and molecular networking analyses across the entire Eremophila genus to provide new knowledge on the presence of natural products and their bioactivities using polypharmocological screens. Sesquiterpenoids, diterpenoids and dimers of branched-chain fatty acids with previously unknown chemical structures were identified. The collection of plant material from the Eremophila genus was carried out according to a 'bioprospecting agreement' with the Government of Western Australia. We recognize that several Eremophila species hold immense cultural significance to Australia's First Peoples. In spite of our best intentions to ensure that new knowledge gained about the genus Eremophila and any potential future benefits are shared in an equitable manner, in accordance with the Nagoya Protocol, we encounter serious dilemmas and potential conflicts in making benefit sharing with Australia's First Peoples a reality.

The Trouble Is, You Think You Have Time: Traditional Knowledge of Indigenous Peoples in Japan and India, the Reality of Biodiversity Exploitation.

This paper aims to illustrate the crucial role of preserving, protecting and managing the environment by Indigenous Peoples in Japan and India. Traditional Knowledge has provided the ability to detect, understand and respond to environmental changes. However, modern science and applied technology often fall short of sustainable practices, acquired through 'centuries of local observation'. Our consumer-centric world has unravelled a sad situation that has contributed to an irretrievable climate crisis. Multilateral instruments, however, have come to the rescue. In this journey, Japan and India have shown the world some constructive initiatives with positive outcomes which could go a long way in achieving the UN-SDGs.

Responsible Research and Innovation Framework, the Nagoya Protocol and Other European Blue Biotechnology Strategies and Regulations: Gaps Analysis and Recommendations for Increased Knowledge in the Marine Biotechnology Community.

As the quest for marine-derived compounds with pharmacological and biotechnological potential upsurges, the importance of following regulations and applying Responsible Research and Innovation (RRI) also increases. This article aims at: (1) presenting an overview of regulations and policies at the international and EU level, while demonstrating a variability in their implementation; (2) highlighting the importance of RRI in biodiscovery; and (3) identifying gaps and providing recommendations on how to improve the market acceptability and compliance of novel Blue Biotechnology compounds. This article is the result of the work of the Working Group 4 "Legal aspects, IPR and Ethics" of the COST Action CA18238 Ocean4Biotech, a network of more than 130 Marine Biotechnology scientists and practitioners from 37 countries. Three qualitative surveys ("Understanding of the Responsible Research and Innovation concept", "Application of the Nagoya Protocol in Your Research", and "Brief Survey about the experiences regarding the Nagoya Protocol") indicate awareness and application gaps of RRI, the Nagoya Protocol, and the current status of EU policies relating to Blue Biotechnology. The article categorises the identified gaps into five main categories (awareness, understanding, education, implementation, and enforcement of the Nagoya Protocol) and provides recommendations for mitigating them at the European, national, and organisational level.

Digital Colonialism and the Fourth Industrial Revolution - Preventing Exploitative Bio-economies.

As the traditional use of non-human genetic resources in research and development is increasingly ceded to computerised research activities, current frameworks for access and benefit-sharing face an impending identity crisis. The absence of international consensus on the regulation of digital sequence information presents a critical point of social division between the Global North and Global South, whereby a culture of "open data" promises immeasurable opportunity in high-income nations and threatens a wave of digital bio-piracy for vulnerable communities. This article critically evaluates these problems and considers solutions which draw on Indigenous Data Sovereignty principles. To do so, it uses the recent experience in Queensland to explore how the law might reconcile and balance these competing interests. Insofar as Queensland is one of the most mega biodiverse regions on earth, boasts a globally competitive life sciences sector, and has a vibrant and longstanding Indigenous population, it offers a unique case study.

Creating space for Indigenous perspectives on access and benefit-sharing: Encouraging researcher use of the Local Contexts Notices.

A recent Molecular Ecology editorial made a proactive statement of support for the "Nagoya Protocol" and the principle of benefit-sharing by requiring authors to provide a "Data Accessibility and Benefit-Sharing Statement" in their articles. Here, we encourage another step that enables Indigenous communities to provide their own definitions and aspirations for access and benefit-sharing alongside the author's "Statement". We invite the Molecular Ecology research community to use Biocultural-, Traditional Knowledge-, and Cultural Institution Notices to help Indigenous communities gain visibility within our research structures. Notices are one of the tools offered by the Biocultural Labels Initiative (part of the Local Contexts system) designed specifically for researchers and institutions. The Notices are highly visible, machine-readable icons that signal the Indigenous provenance of genetic resources, and rights of Indigenous communities to define the future use of genetic resources and derived benefits. The Notices invite collaboration with Indigenous communities and create spaces within our research systems for them to define the provenance, protocols, and permissions associated with genetic resources using Labels. Authors contributing to Molecular Ecology can apply Notices to their articles by providing the persistent unique identifier and an optional use-statement associated with the Notice in their "Data Accessibility and Benefit-Sharing Statement". In this way, our research community has an opportunity to accelerate support for the principles of the Nagoya Protocol, to alleviate concerns regarding Indigenous Data Sovereignty and equitable outcomes, and to build better relationships with Indigenous collaborators to enhance research, biodiversity, and conservation outcomes.

QTL analysis for early growth in an intercross between native Japanese Nagoya and White Plymouth Rock chicken breeds using RAD sequencing-based SNP markers.

An F2 population of 239 chickens was obtained by an intercross between Nagoya (NAG), a native Japanese breed with low growth, and White Plymouth Rock (WPR), a Western breed with high growth. Using SNP markers obtained by restriction site-associated DNA sequencing, genome-wide QTL analysis was performed and it revealed three QTL for early postnatal growth in the F2 population at genome-wide 5% significance levels. The most highly significant QTL affecting body weights at 2-4 weeks of age and weight gains at 2-3 and 0-4 weeks was located on GGA4 between 34.0 and 65.6 Mb with LOD scores of 3.9-5.9 and it explained 4.9-9.9% of the total variance of the traits. The analysis provided evidence for significant QTL on GGA2 between 105.6 and 125.2 Mb (LOD = 4.6) and on GGA1 between 51.1 and 61.6 Mb (LOD = 4.0) which had effects on body weight at 3 weeks and body weight gain at 0-1 week respectively. These two genomic regions explained 6.6 and 6.9% of the phenotypic F2 variance of the corresponding traits respectively. The allele derived from WPR at all QTL increased the corresponding traits. Neither sex-specific nor epistatic QTL was detected. The results showed that the GGA4 QTL affecting multiple traits is a key locus responsible for early growth in our chicken cross, suggesting that this QTL may make a great contribution to genetic improvement of growth performance of the NAG breed with a low growth rate.

A Primer to Traditional Knowledge Protection in India: The Road Ahead.

As India moves ahead in the twenty-first century to be a global player, it must take a balanced and inclusive approach. Marginalized and vulnerable tribal communities make approximately 10% of the massive population, playing a dynamic role in this regard. Their ancestral knowledge can be explored to inculcate the ethos in multiple disciplines. This would most certainly bring the much-needed balance in achieving the United Nations Sustainable Development Goals. Where the world is fast losing its natural resources, promoting traditional knowledge (TK) could become an initiative for its reconstruction in post-COVID 19 scenarios. Apart from reinstating the rights of these indigenous communities, this step would also facilitate the economic benefit of the country through the incorporation of TK in the realm of Intellectual Property. This would be a masterstroke for India to lead the Global South. This would also bring in a balance with the Global North, where significant developments have already taken place, in this regard. TK per se should not necessarily be protectable unless based on scientific evidence.

Clarification of access regulations to genetic resources that are subject to the sovereign rights of sovereign states and the deposit of nomenclatural types under the International Code of Nomenclature of Prokaryotes.

One of the goals of the International Code of Nomenclature of Prokaryotes is not only to make nomenclature transparent and predictable, but to also make sure that the biological material on which it is based is available to either verify previous work or to allow further work to be undertaken. The key elements in ensuring the latter two aspects are nomenclatural types (type strains) at the rank of species and subspecies. With increasing regulations controlling access to genetic resources, the limitations put on access are not always evident at the time novel species or subspecies are proposed and corresponding nomenclatural types (type strains) designated. In a number of cases, limitations put on access have been discovered after the fact.

The Rooibos Benefit Sharing Agreement-Breaking New Ground with Respect, Honesty, Fairness, and Care.

The 1992 Convention on Biological Diversity (CBD) and its 2010 Nagoya Protocol brought about a breakthrough in global policy making. They combined a concern for the environment with a commitment to resolving longstanding human injustices regarding access to, and use of biological resources. In particular, the traditional knowledge of indigenous communities was no longer going to be exploited without fair benefit sharing. Yet, for 25 years after the adoption of the CBD, there were no major benefit sharing agreements that led to significant funding streams for indigenous communities. This changed with the signing of the Rooibos Benefit Sharing Agreement in South Africa, described in this paper. As the authors report, the Rooibos Agreement is a superlative in two respects. It is the biggest benefit sharing agreement between industry and indigenous peoples to date. It is also the first industry-wide agreement to be formed in accordance with biodiversity legislation. This article is a co-production between traditional knowledge holders, the lawyer who represented their interests, the Co-Chair of the Nagoya Protocol negotiations, and an ethicist who analyzed the major challenges of this historic agreement. With no precedent in the benefit sharing world, the agreement stands as a concrete example of the 'art of the possible.' Although the rooibos case is unique in a number of aspects, the experience offers many transferable insights, including: patience; incrementalism; honesty; trust; genuine dialogue; strong legal support; a shared recognition that a fair, win-win deal is possible; government leadership; and unity amongst indigenous peoples. Such ingredients of success can apply well beyond southern Africa.

Digital biopiracy and the (dis)assembling of the Nagoya Protocol.

Technological leaps in DNA sequencing and synthesis are disrupting tenuous access and benefit-sharing (ABS) arrangements between 'users' and 'providers' of genetic resources. For some this signals a new era of open-source gene banks to address global challenges, but to others it threatens a new wave of unjust digital biopiracy. This paper explores the issue of digital sequence information (DSI) at the 2016 Cancun negotiations of the UN Convention on Biological Diversity and its Nagoya Protocol on ABS, and its continued relevance today. While some research has addressed potential solutions to digital sequencing and ABS, little attention has been paid to the problematization of the issue itself. This paper addresses this gap with a fine-grained view of the negotiations as an ethnographic site of contestation. We approach the Nagoya Protocol as an assemblage seeking to govern ABS. We trace how the unruly component of DSI threatens this already fragile assemblage by disrupting simplified notions of genetic resources, scientific discovery, and R&D. Our data from the negotiations reveals three major points of tension: the materiality of genetic resources; the problem's novelty; and the problem's urgency. Two opposing solutions raised in response to these contestations reveal underlying faultlines that we argue will continue to destabilise the broader ABS assemblage if left unresolved. Our attention to processes of assemblage (trans)formation offers insights to the historically fragile arrangements of ABS and, more broadly, assemblages of global environmental governance in the context of rapid technological change.

Public Microbial Resource Centers: Key Hubs for Findable, Accessible, Interoperable, and Reusable (FAIR) Microorganisms and Genetic Materials.

In the context of open science, the availability of research materials is essential for knowledge accumulation and to maximize the impact of scientific research. In microbiology, microbial domain biological resource centers (mBRCs) have long-standing experience in preserving and distributing authenticated microbial strains and genetic materials (e.g., recombinant plasmids and DNA libraries) to support new discoveries and follow-on studies. These culture collections play a central role in the conservation of microbial biodiversity and have expertise in cultivation, characterization, and taxonomy of microorganisms. Information associated with preserved biological resources is recorded in databases and is accessible through online catalogues. Legal expertise developed by mBRCs guarantees end users the traceability and legality of the acquired material, notably with respect to the Nagoya Protocol. However, awareness of the advantages of depositing biological materials in professional repositories remains low, and the necessity of securing strains and genetic resources for future research must be emphasized. This review describes the unique position of mBRCs in microbiology and molecular biology through their history, evolving roles, expertise, services, challenges, and international collaborations. It also calls for an increased deposit of strains and genetic resources, a responsibility shared by scientists, funding agencies, and publishers. Journal policies requesting a deposit during submission of a manuscript represent one of the measures to make more biological materials available to the broader community, hence fully releasing their potential and improving openness and reproducibility in scientific research.

Collecting wild Miscanthus germplasm in Asia for crop improvement and conservation in Europe whilst adhering to the guidelines of the United Nations' Convention on Biological Diversity.

BACKGROUND AND AIMS: Germplasm with diverse, agronomically relevant traits forms the foundation of a successful plant breeding programme. Since 1993, the United Nations has been advocating the implementation of the Convention on Biological Diversity (CBD) and the subsequent 2002 Bonn Guidelines as international best practice on germplasm collection and use. In 2006, a European team made an expedition to Asia to collect wild germplasm of Miscanthus, a C4 perennial rhizomatous grass, for breeding an environmentally adaptable, resilient and high-yielding bioenergy crop. We outline general aspects of germplasm collection, conservation, breeding and biomass production evaluation while following the CBD's guidelines, respecting biodiversity and conservation needs, and the ethical use of genetic resources. METHODS: Effective protocols, quarantine, methods for collecting seed and rhizomes, and a genebank for conservation were established. Versatile informatics and database architecture were used to assist in selection, flowering synchronization, crossing, evaluation, phenotyping and data integration. Approaches were formulated to comply with the CBD guidelines. KEY RESULTS: A total of 303 accessions of M. sinensis, M. sacchariflorus and M. floridulus were collected from 158 geographically and environmentally diverse locations. These species were shown to accumulate different amounts of aerial biomass due to combinations of stem count, height and thickness. Progeny from one interspecies cross accumulated more biomass in early trials and has shown double the yield performance in years 3-4 compared with the existing commercial cultivar M. × giganteus. An example of an F1 hybrid has already demonstrated the long-term potential of exploiting this collection for a breeding programme. CONCLUSIONS: By conforming to the CBD principles, the authors' international collaboration provides a practical example of implementing the CBD. The collection widened the genetic diversity of Miscanthus available to allow for breeding of novel hybrids that exhibit more diverse traits to increase yield and resilience for growth on marginal land and in climate-challenged environments.

Fungal biological resources to support international development: challenges and opportunities.

Exploitation of microbes, especially fungi, has the potential to help humankind meet the UN's sustainable development goals, help feed the worlds growing population and improve bioeconomies of poorer nations. The majority of the world's fungal genetic resources are held in collections in developed countries, primarily within the USA, Europe and Japan. Very little capacity exists in low to middle income countries, which are often rich in biodiversity but lack resources to be able to conserve and exploit their own microbial resources. In this paper we review the current challenges facing culture collections and the challenges of integrating new approaches, the worth of collaborative networks, and the importance of technology, taxonomy and data handling. We address the need to underpin research and development in developing countries through the need to build 'in country' infrastructure to address these challenges, whilst tackling the global challenges to meet the requirements of the research community through the impacts of legislation and the Nagoya protocol on access to biological resources.

Pathogens collections, biobanks and related-data in a One Health legal and ethical perspective.

Research on emerging infectious diseases calls for a work on collections of pathogens (including hosts or vectors from which the pathogens were isolated), related to human and animal health, to wildlife or on the environmental material. In this respect, the adoption of a One Health perspective is determined by the need for a common approach to consider the collection, storage and use of pathogens coming from human or non-human sources, and particularly when the same pathogen is taken from different environments. In response to this development, our purpose is to delineate a flexible regulation framework concerning collections of pathogens from various origins or hosts and their associated data in order to facilitate scientific work and research partnerships. The legal and ethical cutting-edge research on Biomedical Big Data is particularly stimulating when it comes to address challenges related to collections or biobanks of pathogens such as prior informed consent and accessibility, Material Transfer Agreement or benefit sharing.

Characteristics of Bone Strength and Metabolism in Type 2 Diabetic Model Nagoya Shibata Yasuda Mice.

We evaluated the suitability of Nagoya Shibata Yasuda (NSY) mice as an animal model for examining the influence of a glucose metabolism disorder on bone integrity, using Institute of Cancer Research (ICR) mice as controls. We selected six NSY and ICR mice each that were matched for weight, and measured serum glucose levels, serum insulin levels, and conducted an oral glucose tolerance test. Histological sections of the femurs of both mouse lines were prepared, and the bone strength, mass, and microstructure of the femur were compared, along with bone metabolism. Serum glucose levels were significantly higher in the NSY mice than in the control mice, but body weight and serum insulin levels did not differ between the groups. Bone mass, microstructure, and strength of the femur, and bone metabolism were lower in the NSY mice than in the control mice. In the cortical bone of the femur in the NSY mice, several parts were not stained with eosin, demonstrating a strong negative correlation between serum glucose levels and bone mineral density; however, there was a negative correlation between serum glucose levels and bone metabolic markers. The bone turnover rate in the NSY mice was decreased by hyperglycemia, resulting in a thinner and shorter femur, reduced cortical and trabecular areas, and lower bone mass compared to those of the control mice. Collectively, these results suggest deteriorated bone strength of the femur in NSY mice, serving as a useful model for studying the link between glucose metabolism and bone integrity.

Who Are Indigenous and Local Communities and What Is Traditional Knowledge for Virus Access and Benefit-sharing? A Textual Analysis of the Convention on Biological Diversity and Its Nagoya Protocol.

The United Nations' Convention on Biological Diversity (1992) (CBD) has become the focal point for the regulation of traditional knowledge (TK) held by indigenous and local communities (ILCs). The legally binding CBD is bolstered by a supplementary, non-binding agreement, The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (2010) (Nagoya Protocol). Both instruments create the conditions for the access and benefit-sharing (ABS) of genetic resources, and for TK associated with those resources. There has been no consideration as to how TK might factor into virus ABS arrangements. Most of the literature on these issues relates to how the TK provisions of the CBD and Nagoya Protocol should be implemented; there is little guidance as to how to interpret the text itself. This article provides a textual analysis of all provisions of the CBD and Nagoya Protocol that relate to TK and the interests of ILCs. The analysis clarifies the differences in scope between the two instruments and will provide some insights as to how to interpret key terms, particularly indigenous and local communities, traditional knowledge and traditional knowledge associated with genetic resources. This is critical to understanding the obligations that apply to accessing virus samples that are regulated as genetic resources under the CBD.

Future access and improvement of industrial lactic acid bacteria cultures.

Industrial fermentations based on micro-organisms such as the lactic acid bacteria (LAB) play an important role in several industries globally and represent multi-billion Euro/dollar businesses. LAB provide a natural way to produce safe, sustainable, and environmentally friendly products for a variety of industries. Product innovation is a key requirement for these industries to survive and grow globally. However, the development of new products may be affected by two man-made constraints; the Nagoya Protocol on benefit sharing and the opposition to the use of modern biotechnology for strain improvement. An expert workshop was held in Amsterdam, May 10-11, 2017 to discuss these challenges; a number of conclusions and recommendations were formulated and will be presented herein.

Yeast culture collections in the twenty-first century: new opportunities and challenges.

The twenty-first century has brought new opportunities and challenges to yeast culture collections, whether they are long-standing or recently established. Basic functions such as archiving, characterizing and distributing yeasts continue, but with expanded responsibilities and emerging opportunities. In addition to a number of well-known, large public repositories, there are dozens of smaller public collections that differ in the range of species and strains preserved, field of emphasis and services offered. Several collections have converted their catalogues to comprehensive databases and synchronize them continuously through public services, making it easier for users worldwide to locate a suitable source for specific yeast strains and the data associated with these yeasts. In-house research such as yeast taxonomy continues to be important at culture collections. Because yeast culture collections preserve a broad diversity of species and strains within a species, they are able to make discoveries in many other areas as well, such as biotechnology, functional, comparative and evolution genomics, bioprocesses and novel products. Due to the implementation of the Convention of Biological Diversity (CBD) and the Nagoya Protocol (NP), there are new requirements for both depositors and users to ensure that yeasts were collected following proper procedures and to guarantee that the country of origin will be considered if benefits arise from a yeast's utilization. Intellectual property rights (IPRs) are extremely relevant to the current access and benefit-sharing (ABS) mechanisms; most research and development involving genetic resources and associated traditional knowledge will be subject to this topic. Copyright © 2016 John Wiley & Sons, Ltd.