Developing standards for a global biological resource centre network

Further reading

Code of Conduct on Biosecurity for BRCs
A Culture collection' voice at the UN
Poster »Biosecurity Code of Conduct for BRCs«

Code of Conduct on Biosecurity for Biological Resource Centres (BRCs)

I. PREAMBLE

Accumulated and advancing knowledge on biological systems offers substantial benefits to mankind, to research and to development in all areas of basic and applied bio-medical and bio-technological sciences. However, this improved knowledge is intrinsically associated with the potential for dual application: for beneficial or malicious purpose. The possibility of using scientific knowledge for peaceful or non-peaceful purposes reflects the dual-use dilemma and confers a responsibility on both those with the knowledge and with the biological resources. The responsibilities of those engaged in the life sciences have an increasing role for in-depth implementation of the Biological and Toxin Weapons Convention (BTWC).  Scientific openness and a sense of security are prerequisites for freedom of scientific work, publication of findings and exchange of bio-resources to carry out activities in the life sciences. This Code of Conduct on Biosecurity is to help microbial Biological Resource Centres (BRCs) promote a basic ethical understanding of science compliant with the BTWC and raise awareness to prevent misuse in the life-sciences context.

This Code intends to raise awareness on biosecurity within and outside BRCs and to clearly demonstrate that BRCs are fully compliant with national and international legislation and support the BTWC as an international norm prohibiting biological weapons. It is not the aim of this Code to influence the range of bio-resources maintained or life science activities performed at BRCs. Above all, this Biosecurity Code of Conduct is meant to complement legislative procedures.

II. SCOPE

The aim of this Code of Conduct is to prevent microbial BRCs from directly or indirectly contributing to the malicious misuse of biological agents and toxins, including the development or production of biological weapons.

BRCs commit themselves to this Code of Conduct on Biosecurity considering their specific situation and key role as an essential part of the international infrastructure underpinning biotechnology: providing the world-wide scientific and industrial communities with authentic biological materials required in research, application and teaching as well as related information and services. Being part of the scientific community they conduct activities in the life sciences, offer training courses, expertise and knowledge and they support the bioeconomy.

Many BRCs are entrusted with the collection and controlled supply of potentially hazardous bio-resources. This requires high responsibility, well-established biorisk analyses and management, and appropriate BRC internal infrastructures, profound knowledge of relevant bio-legislation including export control and respective protective measures. This Code calls for implementation and compliance of awareness, accountability and oversight and targets all those engaged in life sciences activities, laboratory workers, managers, stakeholders and others.

III. CODE

(1) BIORISK MANAGEMENT

  • Integrate biorisk management throughout the organization and seek its continuous improvement.
  • Assign adequate resources and responsibility to guarantee compliance with legal requirements, communication to staff and relevant third parties, and carry out reliable and appropriate risk assessment.

(2) RAISING AWARENESS

  • Devote specific attention in the education and further training of all staff on:
    - the dual use dilemma i.e. the risks of misuse of biological material, information and life sciences research
    - the requirements of regulations in this context.
  • Provide regular training and carry out auditing to maintain up to date knowledge on biosecurity.
  • Raise awareness of related third parties on their responsibilities.

(3) REPORTING MISUSE

  • Encourage a culture of reporting misuse.
  • Report any finding or suspicion of misuse of biological material, information or technology directly to competent persons or commissions.
  • Protect persons reporting on misuse and ensure that they do not suffer any harassment as a consequence.

(4) INTERNAL AND EXTERNAL COMMUNICATION

  • Prevent access by unauthorised persons to internal and external e-mails, post, telephone calls and data concerning information about potential dual-use research or potential dual-use materials.
  • Regulate the communication of sensitive information.

(5) RESEARCH AND SHARING KNOWLEDGE

  • Assess possible dual-use aspects of research during the application for and the execution of research projects.
  • Minimize the risk that publication of results on potential dual-use organisms will contribute to misuse of that knowledge.
  • Consider biosecurity implications when sharing knowledge.

(6) ACCESSIBILITY

  • Ensure physical security of and access control to stored potential dual-use material in accordance with its risk classification.
  • Implement access control for staff and visitors where potential dual-use biological materials are stored or used.

(7) SUPPLY, SHIPMENT AND TRANSPORT

  • Screen recipients of potential dual-use biological materials, in consultation with the relevant authorities and parties.
  • Select transporters suitable to handle potential dual-use biological materials.
  • Perform export control in accordance with applicable regulations.

 

Knowing is not enough,
We must apply.
Willing is not enough,
We must do.
J. W. von Goethe

A culture collections’ voice at the United Nations

C. Rohde, D. Fritze, D. Martin, D. Smith and J. Stalpers

The Seventh Review Conference of the Biological and Toxin Weapons Convention, BTWC, took place at the UN, Geneva, 05-22 December 2011, under the leading motto of Goethe’s words.

This 7th RevCon was – as some delegates pointed out - the first one with quite an open atmosphere enabling the UN States Delegations to articulate their expectations concerning the sustainable success for the BTWC and for better verification mechanisms. Currently, 171 States are signatories to the Convention, 16 countries are yet to ratify and 23 states are non-signatories (see www.opbw.org). Each year, there is an expert conference and a Delegates conference on the BTWC. So, the BTWC is constantly monitored. The main BTWC focuses are potential bio-weapons state programmes and potential terrorist attacks by non-state actors. The 6th RevCon was in 2006. All previous RevCons had been unsuccessful: the effectiveness of the BTWC remains incomparable to the Chemical Weapons Convention. The 7th RevCon was the first one giving selected NGOs the chance to make statements, also, for the first time the President (currently, Paul van den Jissel) invited the NGOs to a special closed session to hear their impressions on the 7th RevCon. He stressed that NGOs need more room in the future as, too important are their missions and too valuable what they postulate.

It was a great honour for the BRC community to be selected as one of eighteen NGO speakers to give an official statement; through the umbrella of GBRCN, the Global Biological Resource Centre Network, the Biosecurity Code of Conduct (CoC), elaborated by an EMbaRC/GBRCN working group and agreed by EMbaRC and GBRCN members at the Utrecht Workshop in September 2011, was presented at the 7th RevCon as a model Biosecurity CoC with high outreach potential and a long-lasting impetus. Repeatedly, State Delegates mentioned the key role of Codes of Conduct, along with awareness raising and confidence building measures; the CoC for BRCs as presented was well received by the RevCon.

The weakness of the BTWC is that verification mechanisms are missing (e.g., no lists); the BTWC is an international convention without true power. We went to the UN to help strengthen the BTWC, to encourage State Delegates to take back home the CoC as a model and to start top-down processes in their countries to implement verification, involving their respective authorities and national legal enforcement mechanisms. Kathryn Nixdorff, a renowned BTWC expert, stressed that Codes of Conduct have outstanding importance in the bio-scientific world, they are the only way to strengthen the BTWC, keeping the dual-use dilemma in mind.

The Biosecurity CoC that we presented to the international States community was seemingly accepted with positive astonishment with the comment “how brief it seems”.

The 7th RevCon was finished on 22nd December and we expect detailed reports in due course of time through the unog website (www.unog.ch).

The UN are the most honourable forum for the Biosecurity CoC from which to get deserved acknowledgement, an important (and unexpected!) milestone. It is now most important that the culture collections adopt the CoC. Together with the Code itself, a background document on the development of the CoC has been written. Furthermore, a procedural practical document is under development that will be a compilation of “step-by-steps” guidance on how to implement the CoC in the daily life of collections – though no others know it better than culture collections. The key issues will be biorisk management, raising awareness, reporting misuse, internal and external communication, research and sharing knowledge, accessibility, supply, shipment and transport.

Moving on from the inaugural EMbaRC/GBRCN working group meeting to develop a Biosecurity CoC in October 2010, Braunschweig; a workshop in September 2011, Utrecht; the presentation via NGO Statement in December 2011, Geneva, we should use the WFCC as the main forum to discuss further steps on how to implement the CoC. What is the next milestone? We anticipate a process being initiated by UN State Delegations but they expect that all culture collections implement the CoC.

The Biosecurity Code of Conduct for BRCs and the accompanying document can be found via www.embarc.eu/biosecurity.html.

Biological Resource Centres underpinning the future of life sciences and biotechnology (PDF-File)
OECD / Russian Federation Workshop on „Biosecurity of Microbial Biological Resources – Complementing Innovation
OECD Best Practice Guidelines for Biological Resource Centres (PDF-File)

Biological Resource Centres underpinning the future of life sciences and biotechnology

The OECD WPB recommendation to support BRCs ‘because they represent global key components of the life sciences and biotechnology’ dates back to the late 90ies. In their brochure on BRCs, Chapter 5 fully recognizes the the importance of access restrictions and supply control on bio-materials. Consequently, a biosecurity expert group was founded, consisting of 22 members. Several meetings were held to discuss the complex aspects covered by the young term “biosecurity”. The discussions proved most difficult because biological substances are classical “dual-use” substances – between bonafide and possible misuse. In addition, differences in experts’ opinions and to some extent in national legislation hampered the harmonisation process while there was clear agreement that implementing biosecurity was considered a must for BRCs, comparable to all other quality management issues.

OECD / Russian Federation Workshop on „Biosecurity of Microbial Biological Resources – Complementing Innovation

At the OECD / Russian Federation Workshop in Moscow, September 2006 and at the (back-to-back) OECD biosecurity experts group meeting, the biosecurity document was brought to a near-to-final status. Remaining questions were on the binding character of the document and on the details of the biosecurity risk assessment of material.

OECD Best Practice Guideline for Biological Resource Centres

The agreed biosecurity document is part of the declassified general OECD Best Practice Guidelines BIO(2007)9FINAL. This valuable information resource for BRC management practices covers the issues:

  • risk assessment
  • new acquisitions
  • physical security of the BRC
  • personnel and visitors security management
  • incident response
  • staff training
  • supply and transport
  • information security

A. Best Practices

General

A selection of best practice guidance documents prepared by practitioners in different domains to ensure biological materials held in laboratories and repositories such as service culture collections and biobanks are maintained and supplied in the best possible  condition.
International Standards Organisation (ISO) web information. Available at http://www.iso.ch/iso/en/ISOOnline.frontpage Accessed December 01, 2007.

Human domain

  • American Association of Blood Banks, 25th Edition of Standards for Blood Banks and Transfusion Services (BB/TS Standards),  2008, 114 pages, ISBN #987-1-56395-261-6.
    Online - http://www.aabb.org/Content/Bookstore/Featured_Publication Accessed 4 March 2022
  • American Association of Tissue Banks, 11th Edition of the Standards for Tissue Banking AATB’s Standards for Tissue Banking.
    Online - http://www.aatb.org/content.asp?pl=616&contentid=617 Accessed 4 March 2022
  • Best practice for repositories I. Collection, storage and retrieval of material of human biological materials for research. International Society for Environmental and Biological Repositories (ISBER), USA. Published in Cell Preservation Technology March 2005 Issue.
  • Coecke,S., Balls, M., Bowe, G., Davis, J., Gstraunthaler, G., Hartung, T., Hay, R., Merten, O-W., Price, A., Schechtman, L., Stacey, G. and Stokes, W. (2005). Guidance on Good Cell Culture Practice, A Report of the Second ECVAM Task Force on Good Cell Culture Practice, ALTA 33, 261-287.
  • Eye Bank Association of America EBAA Medical Standards.
    Online - https://www.eyebankassociation.org/EWEB/DynamicPage.aspx?Site=ebaa&WebKey=0f144722-d06f-43f8-89d9-eee736b717ad Accessed 4 March 2022
  • Good Tissue Practices, Food and Drug Administration (FDA) manufacturers of human cells and tissue good tissue practice (GTP).
    Online - http://www.fda.gov/CBER/rules/gtp.pdf Accessed 4 March 2022
  • National Cancer Institute Best Practices for Biospecimen Resources, 2007 National Cancer Institute, United States Department of Health and Human services
  • OECD Best Practice Guidelines for Biological Resource Centres.
    Online - http://www.oecd.org/dataoecd/6/27/38778261.pdf Accessed December 01, 2021
  • UKCCCR Guidelines for the Use of Cell Lines in Cancer Research British Journal of Cancer (2000) 82, 1495-1509.
  • ISBI Guidance document: Consensus document for Banking and Supply of Human Embryonic Stem Cell Lines for Research Purposes – ISCF International Cell Banking Initiative.
    Online - http://www.stemcellforum.org/forum_initiatives/international_stem_cell_banking_initiative/iscbi_guidance.cfm

Microbiological domain

  • Anon (1999) Guidelines for the Establishment and Operation of Collections of Cultures of Microorganisms. Second edition. Campinas: World Federation for Culture Collections.
    Online - http://www.wfcc.info/guideline.html Accessed December 03, 2021
  • Common Access to Biological Resources and Information (CABRI) guidelines (http://www.cabri.org).
  • Hawksworth, D.L. & Schipper, M.A.A. (1989).  Criteria for consideration in the accreditation of culture collections participating in MINE, the Microbial Information Network Europe.  MIRCEN Journal 5, 277-281.
  • UKNCC quality management system (http://www.ukncc.co.uk)
  • Additional non BRC specific: Good Laboratory Practice (GLP), ISO 17025, ISO Guide 25 and, as described above, the ISO 9000 series.
  • OECD Best Practice Guidelines for Biological Resource Centres.
    Online - http://www.oecd.org/dataoecd/6/27/38778261.pdf Accessed December 01, 2021
  • CABRI Guidelines – Best practices on the management of microorganisms and cell cultures and an electronic catalogue of strains http://www.cabri.org/gidelines.html

Plant domain

  • Anon (1994).  Genebank standards.  Food and Agriculture Organization of the United Nations, Rome, International Plant Genetic Resources Institute, Rome.  ISBN 92 9043 236 5.

Animal domain

  • See ISBER Best Practice above

B. Biodiversity and BRCs

Some links and articles on biodiversity, taxonomy and biological resource centres.

  • Bacterial Code of Nomenclature: http://www.the-icsp.org/misc/Code history.htm
  • Bacterial Nomenclature up-to-date: http://www.dsmz.de/bactnom/bactname.htm
  • List of bacterial names with standing in nomenclature: http://www.bacterio.cict.fr/
  • Biological Resource Centres – Underpinning the Future of Life Sciences and Biotechnology.
    Online - http://oecdpublications.gfi-nb.com/cgi-bin/oecdbookshop.storefront Accessed December 01, 2021
  • Dworkin M. et al. (2003), The prokaryotes: An evolving Electronic Resource for Microbiological Community
    Online - http://link.springer-ny.com/link/service/books/10125 printed version: 7 volumes
  • Index fungorum web information.
    Available at http://www.speciesfungorum.org/Names/Names.asp Accessed December 01, 2021
  • International Committee on Systematics of Prokaryotes (ICSP): http://www.the-icsp.org/
  • B.E. Kirsop and D.L. Hawksworth, The Biodiversity of Microorganisms and the Role of Microbial Resource Centres, World Federation for Culture Collections, Braunschweig, Germany, 1994.
  • MycoBank: MycoBank is an on-line database aimed as a service to the mycological and scientific society by documenting mycological nomenclatural novelties (new names and combinations) and associated data, for example descriptions and illustrations.
    Online - http://www.mycobank.org/
  • Viruses’ names: http://www.ncbi.nlm.nih.gov/ICTVdb/

C. Biotechnology and the Bioeconomy

  • Donn Szaro, Ernst & Young, Beyond Borders: Global Biotechnology Report, 2006.
  • D.J. Newman and G.M. Cragg, J. Nat. Prod. 70, 461-477 (2007).
  • The Bioeconomy to 2030: designing a policy agenda. OECD Publications 2009
  • Budapest Treaty on the International Recognition of the Deposit of Micro-organisms for the Purposes of Patent Procedure web information. Available at
    Online - http://www.wipo.int/treaties/en/registration/budapest/
  • WIPO - World Intellectual Property Organization: http://www.wipo.int

D. Collection Management and Preservation

  • Microbiological Common Language (MCL): a standard for electronic
    information exchange in the Microbial Commons
    ; Bert Verslyppe, Renzo Kottmann, Wim De Smet, Bernard De Baets, Paul De Vos, Peter Dawyndt, accepted 12 February 2022
  • EBRCN Information Resource
    Online - http://www.wfcc.info Accessed December 01, 2007.
  • Code of practice for IDAs web information.
    Available at http://bccm.belspo.be/tbu/ida/index.php Accessed December 01, 2007.
  • Micro-Organisms, Sustainable Access and use, International Code of Conduct (MOSAICC) web information.
    Available at http://bccm.belspo.be/projects/mosaicc Accessed December 01, 2007.
  • D. Smith and C. Rohde, UK: Society for Microbiology
    Online - http://www.sgm.ac.uk/pubs/micro_today/pdf/0299brc.pdf Accessed November 21, 2007.
  • D. Smith, M.J. Ryan and J.G. Day. The UK National Culture Collection Biological Resource: Properties, maintenance and management. UK National Culture Collection, Egham, UK, 2001.
  • WHO Biosafety Manual
    Online - http://www.who.int/csr/resources/publications/biosafety/who_cds_csr_lyo_20034/en/
  • J.D. Day and G. Stacey, Cryopreservation and Freeze-Drying Protocols, Second Edition, Humana Press, USA, 2007.
  • J. Swings and I. Kurtboke, Microbial Genetic Resources and Biodiscovery, World Federation for Culture Collections, UK, 2000.

E. Culture collection organisations and networks

  • World Data Centre for Microorganisms (WDCM) web information
    Available at http://wdcm.nig.ac.jp Accessed December 01, 2007.
  • World Federation for Culture Collections web information
    Available at http://www.wfcc.info Accessed December 01, 2007.
  • European Culture Collection Organisation (ECCO) web information
    Available at http://www.eccosite.org Accessed December 01, 2007.
  • UK National Culture Collection web information.
    Available at http://www.ukncc.co.uk Accessed December 01, 2007.
  • Belgian Coordinated Collection Collections of Microorganisms web information.
    Available at http://www.bccm.belspo.be Accessed December 01, 2007.
  • Common Access to Biological Resources and Information web information.
    Available at http://www.cabri.org Accessed December 01, 2007.
  • The Asian Consortium for the Conservation and Sustainable Utilisation of Microbial Resources (ACM) web information.
    ACM – catalogues: http://www.abrcn.net
  • The MIRCEN Secretariat, United Nations Educational Scientific and Cultural Organisation (UNESCO) web information.

F. Biosafety - Biosecurity - Transport

  • The OECD have created a web based information resource on biosecurity codes and practices: http://www.biosecuritycodes.org

Other useful links in this context are:

  • The Australia Group: http://www.australiagroup.net
  • Biological Weapons Convention (BWC): http://www.un.org/disarmament/WMD/Bio/BioSecondPageBWC.shtml
  • The EU has adopted a common position with the Biological and Toxic Weapons Convention. Delivery of microorganisms which could be used as biological weapons is controlled by the EU Council Regulation 3381/94 on the Control of Exports of Dual-use Goods from the Community and by the resp. EU Council Decision of December 1994 with its Annex I (Publication L367/8/EEC of 31.12.2021 and amendments). Additionally, some countries have additional legislation.
  • Convention on Biological Diversity web information.
    Available at http://www.biodiv.org Accessed December 01, 2007.

Texts and links on transportation of biological materials

  • IATA - International Air Transport Association Dangerous Goods Regulations
    Online - http://www.iata.org Accessed December 01, 2007.
  • An example of transport regulations is the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR regulations). The ADR regulations can be found at the following web link: http://www.unece.org/trans/danger/publi/adr/ADRagree_e.pdf
  • Micro-Organisms Sustainable use and Access regulation International Code of Conduct – suggested procedures for compliance with the Convention of  Biological Diversity when accessing and distributing microorganisms.
    Online - www.belspo.be/bccm/mosaicc
  • Universal Postal Union for user guides and information on what can be sent in the mail.
    Online - http://www.upu.int/
  • WHO Guidance on Regulations for the Transport on Infectious Substances
    Download - http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2007_2cc.pdf

International Regulations for Packaging and Shipping of Microorganisms; European Biological Resources Centre Network (EBRCN) Information Resource

  • This revised EBRCN information resource is based on the UN Model Regulations for the Transport of Dangerous Goods, 16th edition, United Nations. A basic information document is also the WHO publication “Guidance on regulations for the Transport of Infectious Substances 2007-2008, WHO/CDS/EPR/2007.2

Biosafety

  • United Nations Industrial Development Organisation (UNIDO) e-Bio-safety training
    Online - http://binas.unido.org/moodle/
  • World Health Organization (WHO) – resource of information on biosafety
    Online - http://www.who.int/en/
  • Belgian Bio-safety Server this site provides information from biological risk groups through health risk assesments to characterisation of GM plants.
    Online - www.biosafety.be
  • American Biological Safety Association (ABSA) - promote biosafety as a scientific discipline and serve the growing needs of biosafety professionals throughout the world. The Association's goals are to provide a professional association that represents the interests and needs of practitioners of biological safety, and to provide a forum for the continued and timely exchange of biosafety information.
    Online - http://www.absa.org
  • European Biosafety Association (EBSA) - EBSA is a non-governmental, non-profit and independent association. It is becoming a recognized platform for knowledge and expertise within the field of biosafety and biosecurity and there are many important activities on our agenda for the year to come.
    Online - http://www.ebsaweb.eu
  • International Biosafety Working Group (IBWG) - the mission of the International Federation of Biosafety Associations (IFBA) is to support and promote biosafety on a national and international level.
    Online - http://www.internationalbiosafety.org/english/index.asp

Columns

  • Science, development, and security: The Global Biological Resource Centre Network; Malcolm Dando, 20 October 2022