The CBS culture collections of micro-organisms are embedded in a scientific environment, which guarantees state of the art quality checks and allowes the development of scientific programmes to improve the quality of the material entrusted to them. CBS was actively involved in setting the standards for modern long-term preservation as well as for data storage, recognizing the necessity of data exchangeability. Already in the eighties common formats for microbial data were developed, which brought the collections to the forefront of digitalization, and greatly facilitated the development of a common catalogue realized in the EU programme CABRI (Common Access to Biotechnological Resources and Information (www.cabri.org). CBS was actively involved in setting up criteria and minimal demands for culture collections within the CABRI framework. In short, CBS developed from a culture collection into a Biological Resource Centre (BRC) according to the OECD definition:
Biological Resource Centres are an essential part of the infrastructure underpinning life sciences and biotechnology. They consist of service providers and repositories of the living cells, genomes of organism, and information relating to heredity and the functions of biological systems. BRCs contain collections of culturable organisms (e.g. micro-organisms, plant, animal and human cells), replicable parts of these organisms, cells and tissues, as well as databases containing molecular, physiological and structural information relevant to these collections and related bioinformatics. BRCs must meet the high standards of quality and expertise demanded by the international community of scientists and industry for the delivery of biological resources on which R&D in the life sciences and the advancement of biotechnology depends.
Biological Resource Centres – Underpinning the Future of Life Sciences and Biotechnology (click here for PDF).
The collections of CBS offer a comprehensive coverage of the culturable biodiversity of the fungal Kingdom (over 50,000 strains), while the prokaryotes are represented by unique collections of bacterial mutants, hosts suitable for DNA research, genetically engineered plasmids, broad-host-range plasmids and phages. A large staff of scientists with expertise on every systematic group represented in the collections and a dedicated staff of technicians for maintenance and distribution, guarantee the quality of the strains and the maintenance of all regulations concerning biosafety.
The Convention of Biological Diversity (CBD)
The CBD, which entered into force on December 29th, 1993, has been ratified by over 190 countries (‘ the Parties’), including the Netherlands. It affects all living genetic resources collected since 1993, thus including microbial strains. The Convention recognizes the sovereign rights of countries over their own biological resources, and aims at fair and equitable sharing of benefits arising from the utilisation of genetic resources and associated traditional knowledge, especially with regard to the country of origin in the case of successful economic exploiting of these genetic resources.
Anyone who intends to collect samples (holding biological resources) from areas within jurisdiction of a country that is a Party to the CBD, should first request for a Prior Informed Consent (PIC) and settle on Mutually Agreed Terms (MAT) with the competent authority in the country of origin, before the actual collecting starts, unless that Party has determined otherwise (for example, is giving free access).
The Nagoya Protocol
The Nagoya Protocol to the CBD on "Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization" was adopted in Nagoya at the 10th Conference of the Parties of the CBD in 2010 and enters into force on October 12th 2014. It is a legally binding treaty that implements the third objective of the CBD namely, the fair and equitable sharing of benefits arising from the utilisation of genetic resources and associated traditional knowledge, including by appropriate access to genetic resources.
To regulate Access and Benefit sharing (ABS) in the European Union, a new Regulation (EU) 511/2014 was designed, which was adopted by European Parliament and the Council on April 16th, 2014. It entered into force on June 9th, 2014. This regulation applies from the same day the Nagoya Protocol enters into force for the Union, thus, from October 12th, 2014.
Obligations for users of genetic resources in the EU are laid down in Art. 4 of the Regulation (EU) No 511/2014, and include, among others:
- to “exercise due diligence”, i.e., to ascertain that genetic resources (and associated traditional knowledge) they utilise have been accessed in accordance with applicable ABS legislation;
- to share benefits arising from the utilisation of the genetic resources, in agreement with MAT and in accordance with legal requirements;
- to transfer and utilise genetic resources (and associated traditional knowledge) only in accordance with MAT (if required);
- to seek, keep and transfer to subsequent users the internationally recognised certificate of compliance (IRCC), information on the content of the mutually agreed term for subsequent users, etc.;
- to keep the information relevant to ABS for 20 years after he end of the period of utilisation.
It is the responsibility of the depositor to ensure that the deposit of the material in an open collection does not infringe on any (inter)national obligation.
Furthermore, depositors of strains are asked to provide all the information that the curator needs to check if any ABS law or regulatory requirements apply to the material. Such information includes, inter alia:
- The geographical origin of the strain (or of the sample from which it was isolated), at least the country of origin, if applicable;
- The date the strain or sample was collected in situ;
- The name and affiliation of the person who collected the strain or sample.
Furthermore, certain documents may be required before the strains can be accepted by CBS, for example, PIC, MAT, or other equivalent documents (preferably to be sent to CBS by e-mail as full-colour scanned copies). Without such documentation, it may not be possible for CBS to fulfill applicable ABS requirements while accessioning, handling and distributing the strain. The CBS strain accession form contains the fields for the information that is needed (check obligatory fields). CBS is also working to install a tool for uploading documents while filling in the form.
Receiving strains from the public CBS Collection
To enable recipients of the CBS-strains (or DNA) to act in agreement with the Nagoya Protocol, CBS will inform them of the country of origin. CBS strains are distributed under the conditions of the CBD. It is the responsibility of the recipient to ensure that the obligations under the CBD and Nagoya Protocol are fulfilled. In order to ensure traceability of the material, recipients are not allowed to transfer the strains to third parties. Strains obtained from CBS used for publications should be cited with their CBS number and the country of origin (if applicable).