WORLD FEDERATION FOR CULTURE COLLECTIONS
GUIDELINES

FOR THE ESTABLISHMENT AND OPERATION
OF 
COLLECTIONS OF CULTURES
OF 
MICROORGANISMS

3rd Edition, February 2010

Revised by the WFCC Executive Board

 

BACKGROUND

The World Federation for Culture Collections (WFCC) is a COMCOF (Committees, Commissions and Federations) of the International Union of Microbiological Societies (IUMS) and a scientific member of the International Union of Biological Sciences (IUBS). It’s key objective is the promotion and development of collections of cultures of microorganisms and cultured cells. Retention and support of existing col ections, as well as assistance and advice to help new col ections become established remain key activities. The members of WFCC constitute a unique global network for ex situ preservation of microbial diversity which underpins life on earth. This is particularly pertinent in 2010, the International Year of Biodiversity. The WFCC has an on-going concern with all aspects of culture collection activity and, in particular, with the encouragement of new initiatives and improvement of the quality standards of scientific services provided to the international user community.

The increasing demands on culture col ections for authenticated, reliable biological material and associated information have paralleled the growth of biotechnology. More recently, the Organisation for Economic Co-operation and Development (OECD) have recognised the importance of taking culture collections to a higher level of quality and delivery to underpin biotechnology. One key element of this development is the introduction of best practice (OECD, 2007), for which the WFCC guidelines laid the foundation. These guidelines have been updated to include recent developments and changes to provide basic quality management guidance for culture col ections. The OECD Best Practice Guidelines for Biological Resource Centres (OECD, 2007) set the standard for quality management and also covers biosecurity, building capacity, preservation of biological esources and data management. The WFCC guidance provides an excellent first step towards the implementation of the OECD Best Practice. It is anticipated that many member collections will be able to implement this guidance in full immediately but it is expected that each agrees to implement it in a reasonable time frame.

It is hoped that these Guidelines prove valuable and encouraging. The WFCC wishes to emphasise that high standards of scientific service can be achieved in laboratories with modest resources and that sophisticated equipment is not a prerequisite for good microbiological practice; the principles listed in the Guidelines must be applied to any culture collection regardless of size or economic standing.

EXECUTIVE SUMMARY

These Guidelines are prepared by the WFCC to provide a framework for the establishment, operation and long-term  support of  microbiological  and cell  resource centres  as  a fundamental part of the scientific infrastructure.

The Guidelines describe:

·      The aims of culture collections
·      The  services they provide to the  international scientific community in terms of resources, information and specialist skils
·      The  long-term  support needed  to  enable them  to provide  these professional services, including:
o  Appropriate operational facilities
o  The staffing levels to allow operation at a high standard
o  The training level of staff with research expertise related to the aims of the collection
·      The contributions made by collections to the research knowledge base in terms of
taxonomic studies, preservation, growth and handling procedures and other linked areas
·      The  capability  of  collections  to meet all  relevant  national  and international regulations concerning the control, transportation and health and safety aspects of resource handling and distribution
·      The need to provide support and training in capacity building on a global basis;
·      The  need  for international  collaboration  to enhance the  value and  quality  of biological resources
·      References and web site links

The guidance demands compliance with national legislation, rules and regulations.

CONTENTS

1. Introduction
2. Organisation
3. Funding
4. Objectives
5. Holdings
6. Staff
7. Preservation
8. Culture Authentication
9. Culture Supply
10. Other Services
11. Documentation
12. Catalogues
13. Research
14. Training
15. Safety and Security
16. National and International Collaboration 
17. Compliance with Legislation 
Selected Bibliography and Web Sites

Useful Addresses

INTRODUCTION 

1.1 The  ever decreasing investment in traditional  taxonomy, the increasing  demand for a molecular approach,  the continued  depletion  of  natural  resources  and  concerns  over biosecurity and climate change brings a heightened awareness of the value of collections of microorganisms.  Conservation  of  genetic  resources  and biodiversity  provides  the  essential underpinning  for emerging  biotechnologically  based  eco-efficient products  and  industries  in both  the developed and  the  developing  world  (OECD, 2001);  an  essential  element in the development of a knowledge-based bioeconomy (OECD, 2009).  

1.2 Many countries and  individual institutions therefore have established or are  establishing publicly  supported  culture  collections  of  microorganisms  for the  first time, either  to provide services to their country or region or in support of their own research programmes.

1.3 The first edition of these guidelines in 1980 was the first attempt to develop guidelines for culture col ections.   Since then,  numerous  guidance  documents  have been  developed (see Safety and Standards websites below) these, and international standards are being applied to the operations of collections today.

1.4  The  objective of  these Guidelines  is  to provide  assistance to those collections  of microorganisms  offering services  outside  their  own institution (service collections), but it is anticipated  that many  of  the  guidelines  will  be  more generally  applicable  to  in-house or
research collections.     Guidance such as  the  CABRI guidelines  (http://cabri.org)  and the OECD Best Practice for Biological  Resource Centres  are designed for  public  service collections  and  are  the  next level  of  guidance,  which require extensive investment to implement.

1.5  WFCC expects  that,  wherever possible,  service collections  will  adopt the Guidelines enumerated  here. Membership of  the WFCC includes  the  obligation  to  implement these standards  to guarantee  consistent and  sustainable quality  of  authentic  materials  and information.

ORGANISATION 

2.1 The parent organisation, or board, under which a culture collection is established should be  fully  aware of  and accept the  responsibilities  inherent in maintaining a public  service to appropriate standards. Commitment to the maintenance of the col ection and its services  in the long-term should therefore be  included in the strategic  plans or objectives of the parent organisation as appropriate. In the case of existing collections, where this responsibility is not explicit, this  aspect should  be  clarified  with  the  Director of  the  parent institute, its  Scientific Council,  senior university  officials, Governing  Board,  or other  such authorities  as  may  be appropriate. 

FUNDING 

3.1 Administration and funding arrangements for collections require a long-term commitment from the parent organisation. Support solely in the form of short-term contracts or without any allocation of core funding is inappropriate for service collections aiming to provide long-term storage and supply services. Even the establishment of small in-house collections requires an
ongoing source of direct, or indirect, financial support from a parent body.

3.2 It is important to consider the level of funding, both now, and likely to be forthcoming on an on-going basis. This must be adequate to provide the range of services being planned and at a standard that users  would expect. If  secure resources  are limited, in general  it is preferable  to restrict  the  primary  objectives  of  the  col ection  to those  which it has  a strong probability of maintaining in the long-term. 

OBJECTIVES 

4.1 Collections require a clearly summarised general statement of their long-term objectives relating to the scope of their holdings and to the range of outside services that are envisaged. 

4.2 In addition, it is often helpful for a collection to have more specific short-term objectives relating  to the coming  1, 3  or 5  -year period. These can  usefully  include  the  numbers  and
groups of strains which it is planned to acquire in that time frame and schedules for installing new facilities and services. 

4.3 Where possible a mission statement in accordance with 4.1 and 4.2 should be prepared which is sufficiently short to reproduce in promotional and other material disseminated. 

HOLDINGS 

5.1  The  scope of  material  and  numbers  of  strains  to be  held requires  careful  consideration and merits discussion with the parent organisation and any funding bodies concerned when the col ection is being established, as this wil  have long-term financial implications. 

5.2  In addition to decisions  on  the  groups  of  microorganisms  to be  maintained, and the numbers  it is  envisaged as  being retained in the  long-term, it is  also necessary  to have a clearly defined accessions policy on which new strains are to be taken into the collection. If this is not decided and many unsolicited strains are accepted uncritical y without due regard to the col ection's objectives, storage capacities, personnel and financial resources can soon become overstretched; at the same time, the range should not be so strictly defined as to limit the effectiveness of the services provided to the users.  Collaboration with other collections to provide broader coverage is essential, networking activities to enable co-ordinated accession policy  must be  considered, whether  at a regional, national  or global  level  (see paragraph 16.1)

5.3  If  strains  are maintained  that are potentially  pathogenic  to man, animals  or plants, or produce  toxic  or hallucinogenic  compounds, those  holdings  should  be  clearly  label ed and kept secure; adherence to any safety regulations in force is mandatory.  National legislation impacts  on  this  and many  countries  require permits  or licences  to  hold, work  with and
distribute such organisms (see EBRCN legislation document on WFCC website).

5.4 Collections vary substantial y in scope with regard to the groups of microorganisms held, geographical emphasis, and user-group orientation. It is beneficial to stress at an early stage areas  in which  the  holdings  are  planned  to  become particularly  rich as  this  will  be  of  the utmost value to both  potential  depositors  of  strains  and those  wishing to acquire strains  or
requiring other services. 

5.5  In considering  which  strains  to maintain, it is  economically  prudent to aim  at complementing  rather  than  duplicating  those already  available through  other service collections.  While it may  be  desirable for collections  to include  some authenticated internationally recognised reference strains, the WFCC wishes to discourage the unnecessary use of  scarce resources.  Wherever possible, new collections  of  microorganisms  being established should collectively  enrich the world's  available genetic  resources  rather than duplicate those already existing. 

5.6 In determining which strengths a new collection should have with respect to its holdings, particular attention should be paid to those already present in that particular country or region as well as those providing international services. Information as to which collections already exist can  be  obtained  from  the  WFCC World Data  Centre  for  Microorganisms  (WDCM)  –
online via the WFCC website. Some other specialist listings are also available (e.g. CABRI, ECCO, JCM etc.).

STAFF

6.1 Culture collections are necessarily labour-intensive. When determining the numbers of full and part-time positions  required  it  is  important to consider  how  time-consuming  the  routine accessions, preservation, maintenance, and viability  checking  will  become as  the  collection approaches  its  target strain numbers. Staff  levels  need  to  be  sufficient not only  for the
incorporation and  maintenance of  cultures, but also to fulfil  the anticipated  level  of  culture supply and other services the collection is to offer. 

6.2  The  effective curation and management of  a culture collection is  a demanding  task. It requires  knowledge not only  of  the  organisms  themselves, but also their  growth and preservation requirements, properties  and potential  applications  and  the provision  of customer services. The  key  staff  member(s)  recruited would be expected  to have a higher degree in an appropriate field and some subsequent direct experience or special training in culture col ection curation  skil s. In order  to attract and retain sufficient calibre staff, arrangements  for ongoing  employment  should be made. Too  frequent  staff  turnover will jeopardize the  maintenance of  standards  in the collection and hence the  quality  and effectiveness of the services provided. 

6.3 Particular attention should be paid to the qualifications and experience of the persons in charge of the Col ection. 

6.4 While it is not always practical to have on staff specialists concerned with, for example, the identification and authentication of al  systematic groups covered, some basic taxonomic skil s are essential for quality control (see para 8.1). Where a need for specialist taxonomic support exists, especially if it relates to services such as identification being advertised, steps need to be taken to provide such expertise through collaborative arrangements within and(or) outside the collection's parent organisation. As such specialist assistance might be required at short-notice, it is preferable for such arrangements to be formal rather than informal. 

PRESERVATION

7.1  Different microorganisms  often  require special  preservation  methods  in order to ensure optimal viability, storage, and purity. For security, and in order to minimise the probability of strains  being  lost, each strain should,  whenever practical,  be maintained by  at least two different procedures. At least one of  these should be  by  freeze-drying  (lyophilisation)  or storage  at ultra low  temperature in liquid nitrogen or mechanical  freezers  maintaining temperatures  of  -140°C or lower cryopreservation);  these are the best methods  for minimising  the risks  of  genetic  change. In some cases, for example cell  lines, where only freezing  is  available, duplicates  should be  stored in separate refrigerators  with different electrical supplies. (See also para 7.3)

7.2 While considerable experience is now available on the optimal preservation methods for many groups of microorganisms, this is not so for all. Particular care is needed with genera and species hitherto not preserved in culture col ections when a greater range of procedures should be attempted or research carried out to determine optimal protocols (See para 14.2). 

7.3  In order  to minimise the  risks  to important genetic  resources  from  fire, flooding, earthquakes, war or catastrophes, col ections  should arrange  to have duplicates  of  at least the  most important and irreplaceable strains  (and also of  their  associated documentation) securely housed in a different building or ideally at a separate site. 

CULTURE AUTHENTICATION 

8.1 Scientists ordering cultures from collections expect them to be correctly identified. If not, there is a danger of users employing the wrong organism in their investigations which could prove time-wasting, expensive, and lead to invalid published results. The name applied to a strain leads into other information relevant to that species including risk group, potential toxin
production, biosecurity risks and therefore it is of critical and prime importance that the name assigned is  correct.   Moreover, without proper  authentication  noxious  organisms  could be inadvertently  supplied. This  places  a grave responsibility  on col ections  and demands attention from  the  time the  first cultures  are received  for preservation.  WFCC member collections  have a responsibility  to provide resources  with accurate identities  as  reference materials if they offer a public service and  must make every effort to ensure that organisms they supply are authentic.

8.2 When named cultures  are received, the person  making the  original identification should be  recorded. The  Col ection should confirm  the  identification and check  that it agrees  with published descriptions of the species. Alternatively, the Collection should confirm that it has been checked by a competent specialist or by comparison with authorised molecular data or other profiles. 

8.3 In the case of unidentified cultures received, the Collection should be wary of identifying material in groups for which it has no specialist taxonomist and it should endeavour to have material checked by specialists prior to incorporation.  Such materials are to be treated with care and assumed to have a high level of risk until a risk assessment and/or the name of the organism has been established.

8.4 In the case of microorganisms which are recognisable from microscopic preparations or dried cultures  (i.e. filamentous  fungi, algae, protozoa), it is  good practice to make such preparations when they are received for deposit, and/or establish molecular barcodes or other profiles  (e.g. MALDI-TOF,  fatty  acids). This  facilitates  the  checking  of  whether a strain recovered from the collection conforms to that originally deposited. 

8.5 The first time (and at appropriate regular intervals afterward) cultures are recovered from the  Col ection, during  aintenance or routine re-preservation  work, or when they  are being dispatched, care should be taken to ensure they conform to the original deposit by carrying out appropriate tests, by comparative study (See para 8.4), or checking by a specialist. 

8.6  The  need  to authenticate  cultures  must be  borne  in mind  when  staff  are recruited, and arrangements for access to specialists have to be made (See para 6.4). 

CULTURE SUPPLY

9.1 Collections should be able to distribute cultures listed as available which are requested. Arrangements for culture supply vary according to the financial basis and policies of the legal owners of the Col ection. 

9.2  Cultures  listed  as  available in catalogues  by  service collections  should  normally  be provided without prejudice  to those requesting  them, subject  to any  import, quarantine or containment regulations  that might apply  and  to normal  credit control  procedures  where charges are required to be made. It is recognised that charging policies and differential rates for users in particular regions or for different purposes (for example teaching vs. industry) may have to be applied in accordance with the policy of the parent organisation or funding body. 

9.3  In offering a culture  supply  service,  consideration  needs  to  be  given  to the  provision of sufficient staff  to satisfy  the numbers  of  requests  it  is  likely  to receive in a timely  manner. Cultures that cannot be dispatched for technical reasons within a reasonable time of receipt of an order with any necessary permits, should be indicated in the Catalogue. 

9.4 Strains  which  are pathogenic  or toxic  to  plants,  animals  or man  often  are subject to regulations from health and(or) agriculture authorities. Scientists requesting strains may need to obtain permits to import material or to handle certain cultures. There are several elements of legislation that impinge upon distribution of organisms:
·  Quarantine – mainly plant (crop) and animal diseases
·  Biosafety – restriction on biosafety level (risk group) or hazard level that can be handled by the recipient
·  Biosecurity – control legislation on the movement of dangerous pathogens
·  Intel ectual  Property  –  for example, Patent Strains  under the  Budapest Treaty often require certificate of release (see para 10.3)

Where cultures  are being supplied  to a  person  or institution  not known to the  Collection, guarantees should be obtained on the credentials of the person concerned and other facilities of the institution before dispatching cultures.

9.5 Collections should maintain detailed records of recipients of cultures showing the material sent (with strain and batch numbers where appropriate), method and date of shipment, and name and address of the person to whom sent. In the case of unsatisfactory results or if it is necessary  to supply  subsequent information  recipients  can then  be  notified.    It is recommended that collections  utilise Material  Transfer Agreements  (MTAs)  to  ensure the recipient is aware of any of the terms and conditions of access.   Example minimum text for such MTAs  can  be found in the  ECCO  MTA  http://www.eccosite.org). Complementary information  is  provided by  MOSAICC (see  Micro-organisms  culture collections, Micro-organisms  Sustainable Use and Access  Regulation International  Code  of  Conduct (MOSAICC)  at http://www.cbd.int/abs/instruments/).

9.6 In dispatching  cultures, attention  needs  to be given  to  pertinent postal  and  shipping regulations regarding packaging and labelling, see Selected Bibliography and para 9.5 9.7 The  WFCC require  al   member  collections  and  recommends  to all  others  that  TYPE strains must be made available without restriction to the scientific community.

OTHER SERVICES 

10.1 Service culture collections may be wel  placed to provide a variety of support services to the scientific and industrial community worldwide or in the region they serve. If such extension services  are contemplated, they  need  to be  carefully  planned as  they  frequently  require additional expertise and facilities. 

10.2 If identification services are to be offered it should be considered whether appropriately trained personnel are available to undertake this demanding task, either in the collection or in an  associated  institution. Major problems  can  arise as  a consequence of  misidentifications
(See paras 6.4, 8.1). 

10.3 Where international  patent depositary  facilities  are to  be  provided, these should  be operated according to the procedures laid down in the Budapest Treaty on the International Recognition  of  the  Deposit of  Microorganisms  for  the  Purposes  of  Patent  Procedure (Regulations, 1977; Guide to the Deposit of Microorganisms under the Budapest Treaty, 1988
[both published by World Intellectual Property Organization (WIPO), Geneva]). In such cases the  col ection would have to qualify  under WIPO  rules  to satisfy  the  stringent  regulations required to become accepted  as  an  International  Depositary  Authority  (IDA). A  code of conduct for International Depository Authorities is available at http://bccm.belspo.be/tbu/ida/index.php.

10.4 If  consultancy, advisory  or investigation  services  are to be  offered, attention must  be given to the provision of appropriate facilities and properly trained personnel (See para 8. 1).

DOCUMENTATION

11.1 Records need to be kept for each strain held and should, at least, include the following categories of information: 

·  Place
·  Substrate or host 
·  Date of isolation
·  Name of person isolating the strain
·  Depositor (or other source of the strain, such as from another Col ection)
·  Name of the person identifying the strain
·  Preservation procedures used
·  Optimal growth media and temperatures
·  Data on biochemical or other characteristics
·  Regulatory  conditions  applying  (relating for example to quarantine,  containment levels and patent status) 

WDCM provides  for an  efficient coding  of  the  strains  by  defining  a collection  acronym  and WFCC number  which allows  each  culture col ection  to  give  a  Global y  Unique Identifiers (GUID)  to each strain of  its  holding, combining their  acronym  with their  own internal numbering. The  pioneering  work  of  WDCM enables  an  appropriate  recording  and management of the documentation related to the strains. Collections should use this system to be part of the WDCM network and be connected to the international scientific community.    

11.2  Whenever resources  permit, the records  should  be  computerised.  Collections  are encouraged  to  adopt  a  field structure  and field  definitions  which will  enable the  data to be integrated into the international and major regional schemes now in operation [e.g. Microbial Information  Network  Europe  (MINE),  CABRI Guidelines, OECD  Best Practice]. Several
compatible programmes exist and the WFCC, WFCC World Data Centre for Microorganisms (WDCM), and CABRI can provide helpful information and suggestions on appropriate levels of  management of  this  information  (see  Bibliography). Even  if  data  exchange  is  not being planned in the  short-term,  it is  wasteful  of  resources  to develop  independent systems  that
already exist. 

11.3  For security, duplicate  computer files  or photocopies  of  records  should  be kept separately, perhaps deposited with duplicate strains (See para 7.3). 

11.4 Where records are computerised, several of the Collection's staff should be familiar with the operation of the system in order to provide cover during periods of absence. 

CATALOGUES

12. Printed or on-line catalogues of the strains available for distribution should be produced or updated at regular intervals. While annual printed catalogues are rarely justified, gaps of five or more years would be too great to be useful. On-line catalogues should be updated more frequently. Cultures with restricted distribution should be clearly marked. Cultures which, for any  reason, are not available for distribution  should not be  listed in catalogues  or publicly accessible databases. 

RESEARCH 

13.1 Research programmes should – when possible - be a part of every Collection's activity. It not  only  helps  attract  staff  of  high  calibre,  but  can  make important contributions  to knowledge of the morphology, taxonomy, physiology, biochemistry and genetics of the groups of  organisms  maintained. Research activities  also ensure that staff  keep abreast of  current developments and are aware of the needs of the user community. 

13.2 Collections  are also wel -placed  to develop  screening  procedures  for particular organisms, preservation  protocols  for strains  difficult to preserve by  routine  procedures  and optimal cultural media and conditions for growth. 

TRAINING

14.1 While Col ection staff require appropriate training themselves, once they have become skil ed they  are wel -placed to train others  in techniques  relating  to culture preservation, growth, and identification. 

14.2 If training is to be provided, it is important to ensure that adequate provision is made for teaching facilities and supervision. 

14.3  WFCC provides  training  often  associated  with its  International  Conference  for Culture Collections (ICCC) but it also provides ad hoc training courses and has a work programme on capacity  building. Additionally, many  culture collections  offer  individual  training  on  different issues. 

SAFETY AND SECURITY 

15.1 Safety aspects of all operations carried out in the Col ection include biosafety, chemical and physical safety etc and need to be carefully scrutinised with respect not only to national health and safety  regulations, but also  with regard to  good  laboratory  practice.   Risk assessments must be carried out before cultures are brought into the collection and specific procedures are applied.  Adequate controls must be implemented to manage risk, not just to collection workers, but to all who may come into contact with cultures, products and services provided including the complete transportation chain.

15.2 Particular attention needs  to be given to the containment and biosecurity  aspects  of strains  which are potential y  harmful  to man, animals  or crops.  WFCC requires  member collections  to implement best practice on  all  safety  and security  aspects  according  to the requirements  and holdings  of  individual  culture collections.  In addition, increased  levels  of
security  are an important consideration when a collection  accepts  secure, safe  or patent deposits where a col ection has additional client and legal obligations to satisfy.

15.3 Facilities  wil   be required for the safe opening  of packages containing new  deposits or material  for identification which could contain harmful  organisms.  Al   steps  involved  in accessioning new materials shall consider biosafety and biosecurity and clear responsibilities shal  be laid down. 

15.4 See section 17 on compliance with al   aspects  of  legislation that are most relevant for culture col ections

NATIONAL AND INTERNATIONAL COLLABORATION

16.1 Many  countries  have  formal  or informal  associations  or federations  of  the  collections within them. These provide  excel ent opportunities  for exchange of  information  and discussions of mutual problems and collections should be encouraged to support them.

16.2 Similarly, the establishment of formal or informal links with any regional groups active in adjacent countries should be encouraged. Examples of such links are the European Culture Collections' Organisation (ECCO) and the Microbial Resource Centres (MIRCEN) network. 

16.3 In order to make their holdings widely known, collections are encouraged to register with the  WFCC World Data  Centre  for  Microorganisms  (WDCM). It is  also recommended  that international  standards  for data exchange and  interoperability  are adopted  to facilitate international communication and data exchange.

16.4 Collections and individual senior staff within collections may join the World Federation for Culture Collections (WFCC). This has  work programmes concerned with education, patents, implementation  of  legislation,  endangered  collections  and standards  which  all  provide information that may be of assistance to new and established collections. The WFCC holds a
major international  congress  every  three years  which provides  a unique forum  for the consideration of all aspects of the activity of culture collections. A Newsletter is produced and training schemes and courses are operated. Col ection staff should be encouraged to actively participate in the affairs of the WFCC. 

COMPLIANCE WITH LEGISLATION

17.1 Operations  of  culture  collections  must be  carried  out safely  and compliant with the various  legislation  and  regulations  that control  these matters. Moreover  the legislation  is subject to changes, which are not always directly communicated to the interested parties. The WFCC through its  Newsletter  and website endeavours  to keep its  membership  and  users informed. In the process of isolation, handling, storage and distribution of microorganisms and cell  cultures  there are many  stages  where compliance with the law, regulations  or international conventions is required. A culture col ection should comply with:

Health and Safety requirements
Classification of Micoorganisms on the Basis of Hazard
Quarantine regulations
Ownership of Intel ectual Property Rights (IPR) 
Convention on Biological Diversity
Safety information provided to the recipient of microorganisms
Regulations governing shipping of cultures
Control of Distribution of Dangerous Organisms
Budapest Treaty (for patent deposits)

Health and Safety
17.2 The institutions’ director/senior management is responsible for the implementation of all  relevant  national  regulations  in the  context of  occupational  health.  A  structure for verifying  this  must  be  set up. The  importance of  a  laboratory’s  health  and safety procedures stretches beyond the laboratory to include all those who may come in contact with  substances  and  products  from  that laboratory. A  risk  assessment of  handling  and supply of organisms is required and should include an assessment of all hazards involved, not just infection, but also al  others amongst which are, the production of toxic metabolites
and the  ability  to cause al ergic  reactions.   Organisms  that produce volatile toxins  or aerosols of spores or cells present a greater risk.  It is the responsibility of the scientist or curator to provide such assessment data where known to a recipient of a culture to ensure its safe handling and containment. 

Regulatory control of microbiology

Classification of Microorganisms on the Basis of Hazard
17.3 Various classification systems exist which include the definitions for classification by the World Health Organisation (WHO); Microorganisms are normally classified on their potential to cause disease, their human pathogenicity, into four risk groups:
Risk Group 1 A biological agent that is most unlikely to cause human disease.
Risk Group 2 A biological agent that may cause human disease and which might be a hazard to laboratory  workers  but is  unlikely  to  spread in the community.   Laboratory exposure rarely  produces  infection  and effective prophylaxis  or  treatment is
available.
Risk Group 3 A biological agent that may cause severe human disease and present a serious hazard to laboratory  workers.   It may  present a risk of  spread in the community but there is usual y effective prophylaxis or treatment.
Risk Group 4 A biological agent that causes severe human disease and is a serious hazard to laboratory  workers.   It may  present a high  risk  of  spread in the  community  and there is usual y no effective prophylaxis or treatment.

Classification  of  animal  and plant  pathogens, their  handling and  distribution  are covered by national and regional legislation.

Quarantine Regulations
17.4 Clients who wish to obtain cultures of non-indigenous pathogens may first have to obtain a permit to import, handle and store from the appropriate Government Department. Under the terms  of  such a licence the shipper  is  required  to see a copy  of  the Ministry  permit before such strains can be supplied. 

Rights to further distribute
17.5 On deposit of biological materials culture collections must ascertain terms and conditions of further distribution, for example, Intel ectual Property rights or from Prior Informed Consent granted under the Convention on Biological Diversity. 

Convention on Biological Diversity
17.6  The  WFCC endorses  the  principles  of  the  Convention  on  Biological  Diversity  and requires biological materials to be received and supplied within the spirit of the CBD. First and foremost the WFCC requires its members to follow its national legislation, rules or regulations, which take precedence. The requirements laid down by countries of origin must be honoured.
Transfer of materials should be accompanied by material transfer agreements or other forms of conditions of supply informing recipients of any terms and conditions that apply.

Safety Information provided to the Recipient of Microorganisms
17.7 It is recommended that a safety data sheet be despatched with an organism indicating which hazard group it belongs  to and  what containment and disposal  procedures  are necessary.   A safety data sheet accompanying a microorganism should include:
·  The hazard group of the organism being despatched 
·  A  definition  of  the  hazards  and assessment of  the  risks  involved  in handling  the organism
·  Requirements for the safe handling and disposal of the organism
- Containment level 

- Opening procedure for cultures and ampoules

- Transport 
- Disposal 
- Procedures in case of spillage 

Regulations governing Shipping of Cultures

17.8 The IATA Dangerous Goods Regulations (DGR) require that shippers of microorganisms of Risk Groups 2, 3 or 4 must be trained by IATA certified and approved instructors (every two years) if cultures are sent by air transport.  Transport of highly pathogenic material classified in Category A, UN 2814 or UN 2900 (see definition of this shipping Category and Table 3.6D,
DGR 2010), requires shippers declaration forms, which accompany the package in duplicate.  Cultures  of  infectious  substances  meeting  the  definition  of  shipping  Category  B, UN 3373 (majority  of the Risk Group 2 organisms), can be transported under deregulated conditions. Different labels and packaging specification markings are used for organisms in transit by air, dependent on the shipping Category.  IATA DGR also requires that packaging used for the transport of Risk Groups 2, 3 or 4 must meet defined standards of a UN combination package. See Addendum II to the current DGR 51st Ed., 2010 and IATA homepage http://www.iata.org.   Category A shipments require a Packing Instruction PI 602 packaging whereas for Category B shipments PI 650 packaging are accepted. PI 650 also meets the requirements of UPU for the transport of Risk group 1 organisms. Generally, there is no lesser packaging quality than PI 650. The WFCC homepage offers information on packaging and shipping. 

Control of Distribution of Dangerous Organisms
17.9 There is considerable concern over the transfer of selected infectious agents capable of causing  substantial  harm  to human  health, animals  or crops.   There is  potential  for such organisms to be passed to parties not equipped to handle them or to persons who may make illegitimate  use of  them.  A  culture collection  must have procedures  to check  the  validity  of
customers that wish to receive dangerous organisms that present a biosecurity risk and if in doubt must not supply. 

The WFCC fully supports the Biological and Toxin Weapons Convention of 1972 (BTWC). But, it is  not the  policy  of  the  WFCC to influence  the range  of  bioresources  maintained  or to interfere with research activities of member collections. National governments and authorities are the enforcers of legislation, control lies with the country in which the col ection is based.
The  WFCC urges  its  members  to strictly  fol ow  all  national  and international  legislation concerning distribution  of sensitive materials to third parties. Such materials shall be clearly labelled and kept secure.  Collections  should  maintain        detailed  records  of  recipients  of  cultures.  The requestors/recipients may need to obtain permits to import or to handle the cultures. In case of trans-border supplies, written and signed guarantees should be obtained on the credentials of  the  requesting person  before despatch  if  other  authorisation  is  not available.  Material transfer agreements  before despatch might be  an  additional  security. In the  case of  new customers, the  recipient’s  institution and  the person’s  name shall  be  checked  against international lists in the context of bio-terrorism. 

SELECTED BIBLIOGRAPHY 

Crous, P.W. (2003)  Adhering  to good cultural  practice (GCP). Mycological  Research News 1378-1379.
Day, J.G. & Stacey, G. (2006) Cryopreservation and Freeze-drying Protocols, 2nd ed.: Springer, ISBN 1597453625, 9781597453622
Gams, W & Hennebert, G L, Stalpers, J, Janssens, D, Schipper, M A A, Smith, J, Yarrow, D & Hawksworth, D L (1988) Structuring strain data for storage and retrieval of information on fungi and yeasts in MINE, the Microbial Information Network Europe.
Journal of General Microbiology 134: 1667-1689. 
Lima, N. & Smith, D. (2003). Biological Resource Centres and the Use of Microbes:
Proceedings of European Culture Col ection Organisation XXII, 17-19 September 2003. Braga, Portugal: Micoteca da Universidade do Minnho. ISBN 972-97916-3-5. pp422.
OECD (2001). Biological  Resource Centres: Underpinning the future of  life sciences  and biotechnology. OECD Publications, Paris, France. pp 66.
OECD (2007). Best Practice Guidelines for Biological Resource Centres (June 2007),http://www.oecd.org/document/36/0,3343,en_2649_34537_38777060_1_1_1_1,00.html
OECD Best Practice Guidelines on Biosecurity for BRCs In: Best Practice Guidelines for Biological Resource Centres (June 2007), http://www.oecd.org/document/36/0,3343,en_2649_34537_38777060_1_1_1_1,00.html
OECD (2009). The Bioeconomy to 2030: designing a policy agenda. OECD Publications.
Ryan, M.J. & Smith, D. (2004) Fungal Genetic Resource Centres and the genomic chal enge. Mycol Res 108, 1351-1362.
Ryan, J.M., Jeffries, P. & Smith, D. (2001). Developing cryopreservation protocols to secure fungal gene function. Cryoletters 22, 115-124.
Ryan, M.J., Smith, D. & Jeffries, P. (2000). A decision-based key to determine the most appropriate protocol for the preservation of fungi.  World Journal of Microbiology & Biotechnology 16, 183-186.
Ryan, M.J., Smith, D., Bridge, P.D., & Jeffries, P. (2003). The relationship between fungal preservation method and secondary metabolite production in Metarhizium anisopliae and Fusarium oxysporum. World Journal of Microbiology and Biotechnology 19, 839- 844.
Smith, D, & Rohde, C. (2007) Biological Resource Centres and compliance with the law. UK: Society for Microbiology http://www.sgm.ac.uk/pubs/micro_today/pdf/0299brc.pdf
Smith, D & Ryan, M.J. (2008). The impact of OECD best practice on the validation of cryopreservation techniques for microorganisms. Cryoletters 29, 63-72.
Smith, D., M.J. Ryan & J.G. Day. (eds) (2001). The UK National Culture Col ection Biological Resource: Properties, maintenance and management. pp 382. UK National Culture Collection, Egham.
Smith, D. & Ryan, M.J. & Stackebrandt, E. (2008) The ex situ conservation of microorganisms: aiming at a certified quality management. In Biotechnology [Eds. Horst W.Doel e, Edgar J.DaSilva], in Encyclopedia of Life Support Systems (EOLSS).
Developed under the Auspices of the UNESCO, Eolss Publishers, Oxford, UK [http://wwweolss.net]
Smith,  D.  &  Ryan, M.J.  (2004) Current  status  of  fungal  collections  and  their  role in biotechnology.  In  Handbook  of  Fungal  Biotechnology  2nd edition. (Arora, D.K., ed), 527-538.Marcel Dekker, Inc. New  York.
Note: Changes to the Code are also documented in the minutes of the ICSP and its Judicial Commission, published in the International Journal of Systematic Bacteriology/International Journal of Systematic and Evolutionary Microbiology.

BIBLIOGRAPHY ON COMPLIANCE WITH LEGISLATION
Anon (1994). Approved Code of Practice for Biological Agents 1994. Health and Safety Executive. Sudbury: HSE Books.
European Commission Directive 95/44/EC of 26 July 1995 establishing the conditions under which certain harmful organisms, plants, plant products and other objects listed in Annexes I to V to Council Directive 77/93/EEC may be introduced into or moved
within the Community or certain protected zones thereof, for trial or scientific purposes and work on varietal selections. Official Journal No. L 184, 03.08.1995, p. 34
European Commission Directive 2000/54/EEC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related exposure to biological agents at work (seventh individual directive within the meaning
of Article 16(1) of Directive 89/391/EEC.
European Council Decision 96/613/CFSP of 22 October 1996 amending Decision 94/942/CFSP on the joint action adopted by the Council on the basis of Article J.3 of the Treaty on European Union concerning the control of exports of dual-use goods.
Official Journal No. L 278, 30.10.1996, p. 1
IATA - International Air Transport Association (2010) Dangerous Goods Regulations. 51st edition. Montreal; Geneva: IATA.
Smith, D. & Desmeth, P. (2007). Access and benefit sharing, a main preoccupation of the World Federation of Culture Collections. In: UNEP/CBD/WG-ABS/6/INF/3 13 December 2007 Compilation of submissions provided by parties, governments,
indigenous and local communities and stakeholders on concrete options on substantive items on the agenda of the fifth and sixth meetings of the ad hoc open ended working group on access and benefit sharing. Canada: UNEP/CBD. p 68-70.
Smith, D. & Rohde, C. (2008) Safety in microbiology. Laboratory Manager Issue 125, 4-6. UK: Croner.

USEFUL WEBSITES

Legislation and operation

Convention on Biological Diversity	http://www.cbd.int/ http://www.cbd.int/abs/instruments/ http://bccm.belspo.be/projects/mosaicc/
EBRCN Information Resource	http://www.wfcc.info
European Commission DGVII – Transport	http://europa.en.int/en/comm/dg07/index.htm
Harmonisation of UN documents etc.	www.hazmat.dot.gov/rules
International Air Transport Association	www.IATA.org/cargo/dg  and www.IATA.org/cargo/dg/links.htm
OECD - Harmonisation Documents
Chemical programme	http://www.oecd.org/ehs
Classification and labelling	http://www.oecd.org/class
Chemical testing	http://www.oecd.org/test
Currently available test guidelines	http://www.oecd.org/test/testlist
UN Committee of Experts for the Transport of Dangerous Goods (UNSCETDG)	www.tc.gc.ca/tdgoods/consult/unlinks_e.htm
Universal Postal Union	http://ibis.ib.upu.org  http://unicc/unece/tra www.de/facil/upustr.htm
World Health Organisation	www.who.org/emc/biosafe/index.htm
World Federation for Culture Collections	http://www.wfcc.info
Organisations

Biodiversity and Biological Collections Web Server
http://muse.bio.cornel .edu/

European Culture Collections’ Organisation     
http://www.eccosite.org

MIRCEN Scholarships
http://www.unesco.org/science/life/life1/rcenform.htm

World Federation for Culture Collections
http://www.wfcc.info

World Data Centre for Micro-organisms
http://www.wdcm.nig.ac.jp

Patents
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure
http://www.wipo.int/treaties/en/registration/budapest/

Code of Practice for IDAs
http://bccm.belspo.be/tbu/ida/index.php

Safety and Standards
Advisory  Committee on  Dangerous Pathogens
http://www.doh.gov.uk/bioinfo.htm

Binas Biosafety Site
http://www.un.org/binas

CABRI – Common Access to Biological
http://www.cabri.org

Resources and Information - Guidelines Cartagena Protocol on Biosafety
http://www.biodiv.org/biosafety/protocol.asp

EC Directive 93/88/EEC on Biological Agents
http://eur-op.eu.int/opnews/395/en/r3633.html

International Organisation for Standardisation
http://www.iso.org/iso/en/ISOOnline.frontpage

OECD Best Practice for BRCs
http://www.oecd.org (Search for BRC)

WHO Biosafety Manual
http://www.who.int/csr/resources/publications/biosafety/who_cds_csr_lyo_20034/en/

UK National Culture Col ection (UKNCC)
Quality Management System
http://www.ukncc.co.uk

Taxonomy and Nomenclature

The creation of a new starting date for prokaryote nomenclature and the mechanism of valid publication of a name is defined in the Bacteriological Code
http://www.ncbi.nlm.nih.gov/books/NBK8817/

Publication of the Approved Lists of Bacterial Names
http://ijs.sgmjournals.org/cgi/reprint/30/1/225

Lists of Bacterial Names is also published in an amended edition
http://www.ncbi.nlm.nih.gov/bookshelf/br.fcgi?book=bacname

Valid publication of names of prokaryotes according to the rules of nomenclature: past history and current practice Int J Syst Evol
Microbiol 2006 56: 2715-2720
http://ijs.sgmjournals.org/cgi/content/full/56/11/2715

Matters relating to the deposit and availability of type strains in collections have been raised: Proposals to clarify how type strains are deposited and made available to the scientific community for the purpose of systematic research Int J Syst Evol
Microbiol 2008 58: 1987-1990.
http://ijs.sgmjournals.org/cgi/content/full/58/8/1987

Confirmation of deposit, but confirmation of what? Int J Syst Evol Microbiol 2008 58: 1785-1787.
http://ijs.sgmjournals.org/cgi/content/full/58/8/1785

A recent review deals with an important aspect in taxonomy, the characterization of strains:
Notes on the characterization of prokaryote strains for taxonomic purposes Int J Syst Evol Microbiol 2010 60: 249-266

http://ijs.sgmjournals.org/cgi/content/full/60/1/249
See also the ICSP website
http://www.the-icsp.org/

The International Committee on Taxonomy of Viruses
http://www.ictvonline.org/index.asp?bhcp=1

Virus taxonomy and provides a database of names
http://www.ncbi.nlm.nih.gov/ICTVdb/

The taxonomy of fungi and yeast is dealt with by the Botanical Code International Code of Botanical Nomenclature (VIENNA
CODE)
http://ibot.sav.sk/icbn/main.htm

Index Fungorum
http://www.indexfungorum.org/

MycoBank
http://www.mycobank.org/

The Botanical Code also covers algae (including cyanobacteria/cyanophytes) and includes protozoa considered to be botanical taxa. This is governed by the IAPT - International Association for Plant Taxonomy
http://www.botanik.univie.ac.at/iapt/index_layer.php

The International Code of Zoological
http://www.iczn.org/iczn/index.jsp

Nomenclature also covers protozoa considered to be zoological taxa International Commission on Zoological Nomenclature
http://www.iczn.org/

ZooBank
http://www.zoobank.org/

USEFUL ADDRESSES 

WDCM - World Data Centre for Microorganisms Contacts: Dr. Juncai Ma, Institute of Microbiology, Chinese Academy of Sciences. NO.1 Beichen West Road, Chaoyang District, Beijing 100101, China . Tel: +86-10-64807422. Fax:+86-10-64807426. email:ma@im.ac.cn

WFCC - World Federation for Culture Collections Contacts: Philippe Desmeth, BCCM, Federal Public Planning Service – Science Policy avenue Louise, 231 1050 Brussels,Belgium. Secretary: Ms Anne Depauw. email:depa@belspo.be

GBRCN – Global Biological Resource Centre Network demonstration project Secretariat
Julius Kühn-Institut (JKI), Bundesforschungsinstitut für Kulturpflanzen (Federal Research Centre for Cultivated Plants), Institute for Crop and Soils Science, Bundesallee 50, 
D-38116 Braunschweig
Tel: +49 531 596 2298
http://www.gbrcn.org

ECCO – European Culture Collections' Organisation
http://www.eccosite.org/

ACM - Asian Collections of Microorganisms
c/o   Dr. Ken Ichiro Suzuki,    NITE Biological Resource Center, National Institute of  Technology and Evaluation,    2-5-8 Kazusakamatari, Kisarazu-shi, Chiba, 292-0818 Japan

 

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