Biotechnology -- Specification on data management and publication in microbial resource centers

This document specifies requirements for data management and publication in microbial resource centres (MRCs) to enable consistent formatting, and a quality control workflow to improve the overall quality of data. It also provides recommendations for MRCs to improve data sharing and integration of microbial material and associated data. This document is intended to facilitate procedures such as accessioning, acquisition, authentication, preservation, storage, and distribution, and can be used by MRCs, regulatory authorities, organizations, and schemes using peer-assessment to confirm or recognize the competence of MRCs in data management and publication NOTE International, national and/or regional regulations or requirements can also apply to specific topics covered in this document.

Biotechnologie -- Spécifications relatives à la gestion et à la publication des données au sein des centres de ressources microbiennes

General Information

Status
Published
Publication Date
08-Nov-2020
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
24-Jun-2020
Completion Date
23-Jun-2020
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INTERNATIONAL ISO
STANDARD 21710
First edition
2020-11
Biotechnology — Specification on
data management and publication in
microbial resource centers
Biotechnologie — Spécifications relatives à la gestion et à
la publication des données au sein des centres de ressources
microbiennes
Reference number
ISO 21710:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO 21710:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 21710:2020(E)
Contents  Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2  Normative references ...................................................................................................................................................................................... 1

3  Terms and definitions ..................................................................................................................................................................................... 1

4  Data publication in MRCs ............................................................................................................................................................................. 5

4.1 General requirements and recommendations for data publication.......................................................... 5

4.2 Data fields of catalogue .................................................................................................................................................................... 6

5  Data management and data quality control ............................................................................................................................ 6

5.1 General ........................................................................................................................................................................................................... 6

5.2 Requirements for in-house data management ............................................................................................................ 6

5.3 Data management for the patent deposit of microbial material and associated data............... 7

5.4 Data management requirements for the transfer and traceability of microbial

material and associated data ...................................................................................................................................................... 7

5.5 Unique identifier of microbial material and associated data .......................................................................... 8

5.6 Data quality control ............................................................................................................................................................................ 9

5.6.1 General procedures and principles .................................................................................................................. 9

5.6.2 Personnel responsibility and authority of data management ...............................................10

5.6.3 Data content and format checking.................................................................................................................10

5.6.4 Recommendations for improving data interoperability .............................................................10

Annex A (informative) Recommended data sets ...................................................................................................................................12

Bibliography .............................................................................................................................................................................................................................24

© ISO 2020 – All rights reserved iii
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ISO 21710:2020(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 276, Biotechnology.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved
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ISO 21710:2020(E)
Introduction

The application of varied data forms in different microbial resource centres (MRCs) for in-house data

management and publication is a major problem, which severely impedes efficient data exchange

globally. It can also hinder depositors/users and potential users of MRCs from accessing their holdings

and related information, and therefore impedes exploitation of microbial material and associated data

in academia and bio-industries in the long run.

This document provides a set of data fields for data publication, aiming to improve data exchange of

online catalogues among MRCs, by applying unique identifiers and a uniform data form. It also helps to

facilitate subsequent access and benefit sharing based on microbial material and associated data.

This document also specifies requirements for data management and internal data quality control to

improve the overall accuracy and reliability of data and information documented in MRCs, which is the

basis of efficient data sharing and exchange.
© ISO 2020 – All rights reserved v
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INTERNATIONAL STANDARD ISO 21710:2020(E)
Biotechnology — Specification on data management and
publication in microbial resource centers
1 Scope

This document specifies requirements for data management and publication in microbial resource

centres (MRCs) to enable consistent formatting, and a quality control workflow to improve the overall

quality of data. It also provides recommendations for MRCs to improve data sharing and integration of

microbial material and associated data.

This document is intended to facilitate procedures such as accessioning, acquisition, authentication,

preservation, storage, and distribution, and can be used by MRCs, regulatory authorities, organizations,

and schemes using peer-assessment to confirm or recognize the competence of MRCs in data

management and publication

NOTE International, national and/or regional regulations or requirements can also apply to specific topics

covered in this document.
2  Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 20387:2018, Biotechnology — Biobanking — General requirements for biobanking
3  Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
accessioning

documenting the addition of a new microbial material (3.17) and/or associated data to an MRC (3.18)

[SOURCE: ISO 20387:2018, 3.1, modified — Replaced “biological” by “microbial”; “a biobank” was

replaced by “an MRC”.]
3.2
acquisition

act of obtaining possession and/or custody of microbial material (3.17) and/or associated data

[SOURCE: ISO 20387:2018, 3.2, modified — Replaced “biological” by “microbial”.]
© ISO 2020 – All rights reserved 1
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ISO 21710:2020(E)
3.3
associated data

any information affiliated with microbial material (3.17) including but not limited to collection,

taxonomic, deposit history and provider data

[SOURCE: ISO 20387:2018, 3.3, modified — Replaced “biological” by “microbial”, the coverage in the

inclusion was modified to data management related categories.]
3.4
authentication

process by which microbial material (3.17) is characterized to a defined level of specification using

appropriate technology/documentation to establish a conclusive basis for accepting the material as

genuine
[SOURCE: ISO 20387:2018, 3.4, modified — Replaced “biological” by “microbial”.]
3.5
catalogue
systematically arranged list or record often including descriptive information
[SOURCE: ISO 20387:2018, 3.10]
Note 1 to entry: It can include printed and online catalogues.
3.6
deposit

act of transferring possession and/or custody of microbial material (3.17) and/or associated data from

depositor (3.7) to MRC (3.18)
3.7
depositor
provider

person or entity from whom/which the microbial materials (3.17) and/or associated data is received or

acquired

[SOURCE: ISO 20387:2018, 3.41, modified — Replaced “biological” by “microbial” and deleted “for

biobanking” at the end.]
3.8
distribution

process of providing selected microbial material (3.17) and/or associated data to recipient(s) (3.24)

[SOURCE: ISO 20387:2018, 3.20, modified — Replaced “biological” by “microbial”; “/user(s)” was

deleted.]
3.9
interoperability

capability to communicate, execute programs, or transfer data among various functional units in a

manner that requires the user to have little or no knowledge of the unique characteristics of those units

[SOURCE: ISO/IEC 20944-1:2013, 3.6.1.24]
3.10
IRCC
international recognized certificate of compliance

permit or equivalent document issued at the time of access as the evidence that the microbial material

(3.17) and associated data has been accessed in accordance with the decision to grant PIC (3.22), and

that MTAs (3.19) have been established for the user and the utilization

Note 1 to entry: When available on the ABS Clearing-House of the Nagoya Protocol, an IRCC number can be

attributed, which can be used as a reference number.
2 © ISO 2020 – All rights reserved
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ISO 21710:2020(E)
Note 2 to entry: This term is based on the Nagoya Protocol.
3.11
legacy microbial material and associated data

microbial material (3.17) and associated data acquired or received by the MRC (3.18) before the MRC

has implemented this document
3.12
life cycle of data

all stages in the process of data usage from initial establishment to its discontinuation

3.13
MAA
material accession agreement
material acquisition agreement

contractual document between a depositor (3.7) and an MRC (3.18) in a material transfer process

Note 1 to entry: It documents basic data such as place and date of sampling in a standardized form, and specifies

the role, rights, and duties of the depositor and MRC.

Note 2 to entry: MAA is synonymous to material deposit agreement (MDA). It is normally put in place by an MRC.

3.14
MAT
mutually agreed terms

contractual arrangements between a provider (3.7) of microbial material (3.17) and/or associated data,

and a recipient (3.24)

Note 1 to entry: It sets out specific conditions for the fair and equitable sharing of benefits arising from the

utilization of microbial materials and/or associated data, and that can also include further conditions and terms

for such utilization as well as subsequent applications and commercialization.
3.15
MDS
minimum dataset

collection of technical and scientific data digitized in specific fields of a database, which is necessary to

distinguish unambiguously a particular microbial material (3.17) and provides a minimum amount of

information available for each accession in an MRC (3.18)

Note 1 to entry: Microbial materials, except for legacy microbial materials, cannot be inserted into the catalogue,

if this information is not available.
3.16
metadata
data that defines and describes other data
[SOURCE: ISO/IEC 11179-1:2015, 3.2.16]
3.17
microbial material

any substance(s) derived or part obtained from a microorganism, and any complexes or association

between microorganisms

Note 1 to entry: It comprises all prokaryotes (archaea and bacteria), some eukaryotic organisms (fungi, yeasts,

algae, protozoa), any association between the latter (e.g. lichens), non-cellular entities (e.g. viruses), their

replicable parts and other derived materials (e.g. genomes, plasmids, cDNA). It also includes some viable but not

yet culturable microorganisms.
© ISO 2020 – All rights reserved 3
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ISO 21710:2020(E)
3.18
MRC
microbial resource centre
microbial biobank
microbial BRC

legal entity or part of a legal entity that performs biobanking of microbial material (3.17) and

associated data
3.19
MTA
material transfer agreement

contractual documents between an MRC (3.18) and a recipient (3.24) in a material transfer process

Note 1 to entry: All the documents can be designated as MTA as long as they contain information about the in situ

origin or the source of the microbial material and associated data, information about the provider and recipient,

and information that defines the limits of the use of the microbial material and associated data

Note 2 to entry: An MTA can also be associated with a microbial material being deposited to meet the need of

its depositor country/country of origin, particularly those that are the parties of the Convention of Biological

Diversity (CBD) and Nagoya Protocol (NP).
3.20
patent deposit

service of MRCs for long-term preservation of microbial materials (3.17) for the purposes of patent

procedure

Note 1 to entry: It is a special service of an MRC recognized as the International Depositary Authority (IDA) by the

World Intellectual Property Organization (WIPO) for the purposes of patent procedures under the Budapest Treaty.

3.21
persistent identifier

unique identifier (3.27) that ensures permanent access for a digital object by providing access to it

independently of its physical location or current ownership

EXAMPLE https:// doi .org/ 10 .1016/ S0140 -6736(20)30251 -8 is an example of a persistent identifier.

Note 1 to entry: It is used in the context of digital objects that are accessible over the Internet. Typically, such an

identifier is not only persistent but also actionable (e.g. URI).

[SOURCE: ISO 24619:2011, 3.2.4, modified — note 1 to entry was entirely replaced to describe the usage

of this term.]
3.22
PIC
prior informed consent

permission of the country of origin to a user to access microbial materials (3.17) and/or associated

traditional knowledge
Note 1 to entry: This term is based on the Nagoya Protocol.
3.23
preservation

act or activity to prevent or retard microbial or physical deterioration of microbial material (3.17)

[SOURCE: ISO 20387:2018, 3.34, modified — Replaced “biological” by “microbial”.]
3.24
recipient
user

person or entity to whom/which the microbial material (3.17) and/or associated data is distributed

[SOURCE: ISO 20387:2018, 3.44, modified — Replaced “biological” by “microbial”.]
4 © ISO 2020 – All rights reserved
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ISO 21710:2020(E)
3.25
safe deposit

service of MRCs for long-term preservation of microbial materials (3.17) with distribution restrictions

at the discretion of the depositor (3.7)

Note 1 to entry: All information concerning the deposit (3.6) and the nature of the microbial materials are treated

in the strictest confidence. Access to this type of microbial material is permitted only by documented request of

the depositor.
3.26
storage

maintenance of microbial material (3.17) under specified conditions for future use

[SOURCE: ISO 20387:2018, 3.47, modified — Replaced “biological” by “microbial”.]
3.27
unique identifier
code that is associated with a single entity within a given system

Note 1 to entry: Such an identifier can establish an unambiguous relationship between each microbial material

and its associated data.
[SOURCE: ISO 20387:2018, 3.50]

Note 2 to entry: It can include accession number and other local identifiers (local IDs) in the web-based context.

3.28
URI
Uniform Resource Identifier

compact sequence of characters that uniquely identify an abstract or physical resource

EXAMPLE http:// gcm .wdcm .org/ Strain _numberToInfoServlet ?strain _number = LMG %2026135 is an

example of an URI in the Global Catalogue of Microorganisms database hosted by WDCM.

Note 1 to entry: URI is a kind of unique identifier (3.17). It is used in the field of computer science.

[14]
[SOURCE: IETF RFC 3986 ]
4  Data publication in MRCs
4.1  General requirements and recommendations for data publication

4.1.1 The MRC shall develop, make available and frequently update online catalogues to keep pace

with the in-house database and display modifications of information in a timely manner.

4.1.2 The MRC shall disclose data associated with the microbial material in the catalogue in accordance

with the agreed terms and conditions presented in the applicable documents (e.g. MTA, MAA) or other

contracts, if any. It is presupposed that these documents are in accordance with applicable statutory and

regulatory requirements.

4.1.3 The MRC shall not disclose sensitive and other restricted information regarding safe deposit and

patent deposit in any form as specified by relevant contracts, if any.

4.1.4 When the depositor requests a delay in the publication of the associated data, the MRC shall

enforce an agreed timeframe and conditions, and may release the data into the catalogue after it is

expired.

4.1.5 The catalogues of MRCs shall contain indispensable service information including ordering,

shipping information, and basic template documents such as forms and agreements to comply with

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ISO 21710:2020(E)

requirements associated with the handling and shipping of microbial materials, which should enable the

efficient use and be user-friendly.

4.1.6 Public data of microbial materials documented in the catalogue of MRCs should be shared

to public databases such as GenBank https:// www .ncbi .nlm .nih .gov/ genbank/ , Global Biodiversity

Information Facility (GBIF) http:// www .gbif .org/ , Catalogue of Global Genome Biodiversity Network

(GGBN) http:// www .ggbn .org/ ggbn _portal/ , WFCC Global Catalogue of Microorganisms (GCM) http://

gcm .wdcm .org/ , if appropriate.

4.1.7 The online catalogue of MRCs should facilitate search capacity across community databases to

support extensive searches for multiple characteristics of microbial materials and improve diversity of

information.
4.2  Data fields of catalogue

4.2.1 The MRC shall properly arrange an accession form for online submission to deposit a microbial

material and associated data efficiently, and it should apply a machine-readable tabular format, if

applicable.

4.2.2 The MRC should ensure the availability of an MDS, and the MDS should include all the following

data fields given in A.2.1: a) accession number, c) organism type, d) status, e) biosafety and biosecurity, f)

other restrictions, and A.2.2: c) history of deposit. The MRC should select all or part of the optional data

fields according to specific circumstances as specified in Annex A.

4.2.3 The MRC should maintain a high quality and cross-referenced online catalogue to link the data

to publicly available controlled vocabularies specified in Annex A and the authorized databases in

accordance with 4.1.6 and 4.1.7.

4.2.3.1 The MRC should link each name of microbial material with publicly available nomenclature

databases to facilitate data retrieval and accessing. The MRC shall indicate the changes of nomenclature

in the printed catalogues.

4.2.3.2 The MRC should link each sequence (e.g. genomic, metagenome, cDNA, RNA and protein

sequences) to publicly available databases.

4.2.3.3 The MRC should link bibliographic information including digitized literature and patent to

publicly available databases and document the DOI numbers, if applicable.
5  Data management and data quality control
5.1  General
The data management of MRC shall be in accordance with ISO20387: 2018, 7.10.
5.2  Requirements for in-house data management

5.2.1 The MRC shall establish, implement and maintain a data management system to ensure that

the essential information is available in the database, e.g. the storage period and location of microbial

materials, frequency of data update and backup, and review and inspection actions for the different

categories of data.

5.2.2 The MRC shall establish and maintain a security system and implement a procedure for the

management of data and related documentation to prevent access by unauthorized users, ensuring

6 © ISO 2020 – All rights reserved
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ISO 21710:2020(E)

information security, bio-security, protection of Intellectual Property Rights (IPRs) and depositor/user

information.

5.2.3 The MRC shall establish and implement a strategic plan for the sustainability of the in-house

data, especially critical details of operation in the preservation process by regular data quality audit, in

order to fulfil traceability of microbial material and associated data, as well as potential risks.

5.2.4 The MRC shall establish, document and implement adequate data quality control (QC) procedures

to reduce the risk of data inaccuracy and unexpected loss, in accordance with the QC specified in

ISO20387:2018, 7.8.3., 7.8.2.8, and 7.2.8.9

5.3  Data management for the patent deposit of microbial material and associated data

5.3.1 Patent deposit related information shall be available exclusively to the depositor, and shall by no

means be included in catalogues or any publicly available lists without a prior documented consent of

the depositor.

5.3.2 The MRC may partly disclose patent related information including patent name, patent number

and accession number in accordance with 4.1.2 to facilitate accessing of the patent deposited materials.

5.3.3 The MRC should document the MDS as specified in 4.2.2 and A.10 c). It should document the

essential information for viability testing and storage in the database.

5.3.4 The MRC shall establish, implement, and document a procedure for the handling of the patent

deposit of microbial material and associated data. It is presupposed that procedures are developed in

accordance with applicable statutory requirements.

NOTE For the parties to the Budapest Treaty, the required documents include the accession form (BP/1),

official notifications to the depositor including the mandatory international form (BP/4), official receipt viability

statements (BP/9) and notification of release to a third party (BP/14).

5.3.5 The MRCs should document major changes of patent deposit including the name of the authorized

representing person, transfer of rights, fate of the culture after the prescribed duration of storage, as well

as the dates when the microbial material was received, returned, accepted, and the date when it was

validated, stored, renewed, withdrawn and destroyed in the database.
5.4  Data management requirements for the transfer and traceability of microbial
material and associated data

5.4.1 The MRC shall ensure persistent identification of a microbial material and traceability of

associated data in accordance with ISO 20387:2018, 7.5.

5.4.2 The MRC within jurisdiction of a CBD and NP Party shall document the transfer related

information of microbial material and associated data and link it to the related documents (e.g. PIC, IRCC,

MTA or MAT) in the database, and introduce the administrative, technical and research output data in the

catalogue.
a) Administrative data:
1) authorization of sampling and/or utilization (e.g. PIC);
2) scope of use;

1) Nagoya Protocol (NP) parties are states that are the parties to the Convention on Biological Diversity (CBD)

signed Nagoya Protocol. The details of NP parties can be found in https:// www .cbd .int/ abs/ nagoya -protocol/

signatories/ .
© ISO 2020 – All rights reserved 7
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ISO 21710:2020(E)
3) status of legislation and related regulations;
4) MTAs.
b) Technical data:

1) information about the in situ origin or the source of the microbiological material;

2) information about the provider and recipient;

3) information of collecting, including place, date of sampling, name of collector, and substrate;

4) risk assessment of the microbial material including risk group/biohazard level, restrictions on

distribution or safety precautions;
5) taxonomical data and the reference;

6) information necessary to ensure the long-term preservation of the microbial material including

growth temperature, media composition, and specific growth conditions.
c) Research output data:

1) information about modifications and unmodified derivatives of the material and associated data;

2) scientific papers, patents, and any commercial results.
5.5  Unique identifier of microbial material and associated data

5.5.1 The MRC shall implement a unique identifier system in accordance with 5.5.1.2 to ensure efficient

retrieval and access to the microbial material associated data.

NOTE The accession number of the legacy microbial material and associated data can be regarded as a

unique identifier, only if the MRC can confirm its uniqueness among all the publicly available information in the

context of life science and biotechnology. For example, an MRC can combine a unique acronym assigned when it

registered in WDCM CCInfo database (http:// www .wfcc .info/ ccinfo/ ) with its local identifier to form a unique

accession number.

5.5.1.1 The MRC should use and refer to pre-existing persistent identifiers (e.g. DOI) in priority.

NOTE Globally unique identifiers assigned by authoritative international organization (e.g. WDCM) and/or

schemes can serve as persistent identifiers in the MRCs.

5.5.1.2 Unique identifiers shall be implemented, documented and maintained in accordance with

ISO 20387:2018, 7.5.1 a).

5.5.2 The MRC shall issue a unique identifier in accordance with 5.5.1.2 to a microbial material at

the time of deposit, and it shall take a long-term view to decide the scope and life cycle of data and the

identifiers they have issued.

5.5.3 The MRC should document the procedure for assigning and maintaining the unique identifiers.

5.5.3.1 The change history of a unique identifier issued by the MRC shall be documented and/or

retrievable.

5.5.3.2 The MRC shall not delete a unique identifier or reassign it to a different microbial material. The

MRC should maintain a list of the obsoleted unique identifiers issued.

NOTE Obsoleted unique identifiers are outdated unique identifiers that will no longer be used.

8 © ISO 2020 – All rights reserved
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ISO 21710:2020(E)
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 21710
ISO/TC 276
Biotechnology — Specification on
Secretariat: DIN
data management and publication in
Voting begins on:
2020­04­28 microbial resource centers
Voting terminates on:
2020­06­23
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 21710:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2020
---------------------- Page: 1 ----------------------
ISO/FDIS 21710:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH­1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 21710:2020(E)
Contents  Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2  Normative references ...................................................................................................................................................................................... 1

3  Terms and definitions ..................................................................................................................................................................................... 1

4  Data publication in MRCs ............................................................................................................................................................................. 5

4.1 General requirements and recommendations for data publication.......................................................... 5

4.2 Data fields of catalogue .................................................................................................................................................................... 6

5  Data management and data quality control ............................................................................................................................ 6

5.1 General ........................................................................................................................................................................................................... 6

5.2 Requirements for in-house data management ............................................................................................................ 6

5.3 Data management for the patent deposit of microbial material and associated data............... 7

5.4 Data management requirements for the transfer and traceability of microbial

material and associated data ...................................................................................................................................................... 7

5.5 Unique identifier of microbial material and associated data .......................................................................... 8

5.6 Data quality control ............................................................................................................................................................................ 9

5.6.1 General procedures and principles .................................................................................................................. 9

5.6.2 Personnel responsibility and authority of data management .................................................. 9

5.6.3 Data content and format checking.................................................................................................................10

5.6.4 Recommendations for improving data interoperability .............................................................10

Annex A (informative) Recommended data sets ...................................................................................................................................12

Bibliography .............................................................................................................................................................................................................................24

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ISO/FDIS 21710:2020(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non­governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 276, Biotechnology.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved
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ISO/FDIS 21710:2020(E)
Introduction

The application of varied data forms in different microbial resource centres (MRCs) for in­house data

management and publication is a major problem, which severely impedes efficient data exchange

globally. It can also hinder depositors/users and potential users of MRCs from accessing their holdings

and related information, and therefore impedes exploitation of microbial material and associated data

in academia and bio­industries in the long run.

This document provides a set of data fields for data publication, aiming to improve data exchange of

online catalogues among MRCs, by applying unique identifiers and a uniform data form. It also helps to

facilitate subsequent access and benefit sharing based on microbial material and associated data.

This document also specifies requirements for data management and internal data quality control to

improve the overall accuracy and reliability of data and information documented in MRCs, which is the

basis of efficient data sharing and exchange.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 21710:2020(E)
Biotechnology — Specification on data management and
publication in microbial resource centers
1 Scope

This document specifies requirements for data management and publication in microbial resource

centres (MRCs) to enable consistent formatting, and a quality control workflow to improve the overall

quality of data. It also provides recommendations for MRCs to improve data sharing and integration of

microbial material and associated data.

This document is intended to facilitate procedures such as accessioning, acquisition, authentication,

preservation, storage, and distribution, and can be used by MRCs, regulatory authorities, organizations,

and schemes using peer-assessment to confirm or recognize the competence of MRCs in data

management and publication

NOTE International, national and/or regional regulations or requirements can also apply to specific topics

covered in this document.
2  Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 20387:2018, Biotechnology — Biobanking — General requirements for biobanking
3  Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
microbial material

any substance(s) derived or part obtained from a microorganism, and any complexes or association

between microorganisms

Note 1 to entry: It comprises all prokaryotes (archaea and bacteria), some eukaryotic organisms (fungi, yeasts,

algae, protozoa), any association between the latter (e.g. lichens), non-cellular entities (e.g. viruses), their

replicable parts and other derived materials (e.g. genomes, plasmids, cDNA). It also includes some viable but not

yet culturable microorganisms.
3.2
associated data

any information affiliated with microbial material (3.1) including but not limited to collection,

taxonomic, deposit history and provider data

[SOURCE: ISO 20387:2018, 3.3, modified — Replaced “biological” by “microbial”, the coverage in the

inclusion was modified to data management related categories.]
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ISO/FDIS 21710:2020(E)
3.3
MRC
microbial resource centre
microbial biobank
microbial BRC

legal entity or part of a legal entity that performs biobanking of microbial material (3.1) and

associated data
3.4
acquisition

act of obtaining possession and/or custody of microbial material (3.1) and/or associated data

[SOURCE: ISO 20387:2018, 3.2, modified — Replaced “biological” by “microbial”.]
3.5
deposit

act of transferring possession and/or custody of microbial material (3.1) and/or associated data from

depositor (3.8) to MRC (3.3)
3.6
safe deposit

service of MRCs for long­term preservation of microbial materials (3.1) with distribution restrictions at

the discretion of the depositor (3.8)

Note 1 to entry: All information concerning the deposit and the nature of the microbial materials are treated in

the strictest confidence. Access to this type of microbial material is permitted only by documented request of the

depositor.
3.7
patent deposit

service of MRCs for long­term preservation of microbial materials (3.1) for the purposes of patent

procedure

Note 1 to entry: It is a special service of an MRC recognized as the International Depositary Authority (IDA) by the

World Intellectual Property Organization (WIPO) for the purposes of patent procedures under the Budapest Treaty.

3.8
depositor
provider

person or entity from whom/which the microbial materials (3.1) and/or associated data is received or

acquired

[SOURCE: ISO 20387:2018, 3.41, modified — Replaced “biological” by “microbial” and deleted “for

biobanking” at the end.]
3.9
recipient
user

person or entity to whom/which the microbial material and/or associated data is distributed

[SOURCE: ISO 20387:2018, 3.44, modified — Replaced “biological” by “microbial”.]
3.10
catalogue
systematically arranged list or record often including descriptive information
[SOURCE: ISO 20387, 3.10]
Note 1 to entry: It can include printed and online catalogues.
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ISO/FDIS 21710:2020(E)
3.11
MDS
minimum dataset

collection of technical and scientific data digitized in specific fields of a database, which is necessary

to distinguish unambiguously a particular microbial material (3.1) and provides a minimum amount of

information available for each accession in an MRC (3.3)

Note 1 to entry: Microbial materials, except for legacy microbial materials, cannot be inserted into the catalogue,

if this information is not available.
3.12
MAA
material accession agreement
material acquisition agreement

contractual document between a depositor (3.8) and an MRC (3.1) in a material transfer process

Note 1 to entry: It documents basic data such as place and date of sampling in a standardized form, and specifies

the role, rights, and duties of the depositor and MRC.

Note 2 to entry: MAA is synonymous to material deposit agreement (MDA). It is normally put in place by an MRC.

3.13
MAT
mutually agreed terms

contractual arrangements between a provider of bio material and/or associated data, and a recipient

Note 1 to entry: It sets out specific conditions for the fair and equitable sharing of benefits arising from the

utilization of microbial materials and/or associated data, and that can also include further conditions and terms

for such utilization as well as subsequent applications and commercialization.
3.14
MTA
material transfer agreement
contractual documents between an MRC and a recipient in a material transfer

Note 1 to entry: All the documents can be designated as MTA as long as they contain information about the in situ

origin or the source of the microbial material and associated data, information about the provider and recipient,

and information that defines the limits of the use of the microbial material and associated data

Note 2 to entry: An MTA can also be associated with a microbial material being deposited to meet the need of

its depositor country/country of origin, particularly those that are the parties of the Convention of Biological

Diversity (CBD) and Nagoya Protocol (NP).
3.15
PIC
prior informed consent

permission of the country of origin to a user to access microbial materials (3.1) and/or associated

traditional knowledge
Note 1 to entry: This term is based on the Nagoya Protocol.
3.16
IRCC
international recognized certificate of compliance

permit or equivalent document issued at the time of access as the evidence that the microbial material

(3.1) and associated data has been accessed in accordance with the decision to grant PIC (3.15), and

that MTAs (3.14) have been established for the user and the utilization

Note 1 to entry: When available on the ABS Clearing-House of the Nagoya Protocol, an IRCC number can be

attributed, which can be used as a reference number.
Note 2 to entry: This term is based on the Nagoya Protocol.
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ISO/FDIS 21710:2020(E)
3.17
unique identifier
code that is associated with a single entity within a given system

Note 1 to entry: Such an identifier can establish an unambiguous relationship between each microbial material

and its associated data.
[SOURCE: ISO 20387:2018, 3.50]

Note 2 to entry: It can include accession number and other local identifiers (local IDs) in the web-based context.

3.18
persistent identifier

unique identifier (3.17) that ensures permanent access for a digital object by providing access to it

independently of its physical location or current ownership

EXAMPLE https:// doi .org/ 10 .1016/ S0140 ­6736(20)30251 ­8 is an example of a persistent identifier.

Note 1 to entry: It is used in the context of digital objects that are accessible over the Internet. Typically, such an

identifier is not only persistent but also actionable (e.g. URI).

[SOURCE: ISO 24619:2011, 3.2.4, modified — note 1 to entry was entirely replaced to describe the usage

of this term.]
3.19
URI
Uniform Resource Identifier

compact sequence of characters that uniquely identify an abstract or physical resource

EXAMPLE http:// gcm .wdcm .org/ Strain _numberToInfoServlet ?strain _number = LMG %2026135 is an

example of an URI in the Global Catalogue of Microorganisms database hosted by WDCM.

Note 1 to entry: URI is a kind of unique identifier (3.17). It is used in the field of computer science.

[14]
[SOURCE: IETF RFC 3986 ]
3.20
interoperability

capability to communicate, execute programs, or transfer data among various functional units in a

manner that requires the user to have little or no knowledge of the unique characteristics of those units

[SOURCE: ISO/IEC 20944-1:2013, 3.6.1.24]
3.21
life cycle of data

all stages in the process of data usage from initial establishment to its discontinuation

3.22
accessioning

documenting the addition of a new microbial material and/or associated data to an MRC

[SOURCE: ISO 20387:2018, 3.1, modified — Replaced “biological” by “microbial”; “a biobank” was

replaced by “an MRC”.]
3.23
authentication

process by which microbial material is characterized to a defined level of specification using appropriate

technology/documentation to establish a conclusive basis for accepting the material as genuine

[SOURCE: ISO 20387:2018, 3.4, modified — Replaced “biological” by “microbial”.]
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ISO/FDIS 21710:2020(E)
3.24
distribution

process of providing selected microbial material and/or associated data to recipient(s)

[SOURCE: ISO 20387:2018, 3.20, modified — Replaced “biological” by “microbial”; “/user(s)” was

deleted.]
3.25
preservation

act to prevent or retard microbial or physical deterioration of microbial material

[SOURCE: ISO 20387:2018, 3.34, modified — Replaced “biological” by “microbial”.]
3.26
storage
maintenance of microbial material under specified conditions for future use
[SOURCE: ISO 20387:2018, 3.47, modified — Replaced “biological” by “microbial”.]
3.27
legacy microbial material and associated data

microbial material and associated data acquired or received by the MRC before the MRC has

implemented this document
3.28
metadata
data that defines and describes other data
[SOURCE: ISO/IEC 11179-1:2015, 3.2.16]
4  Data publication in MRCs
4.1  General requirements and recommendations for data publication

4.1.1 The MRC shall develop, make available and frequently update online catalogues to keep pace

with the in-house database and display modifications of information in a timely manner.

4.1.2 The MRC shall disclose data associated with the microbial material in the catalogue in accordance

with the agreed terms and conditions presented in the applicable documents (e.g. MTA, MAA) or other

contracts, if any. It is presupposed that these documents are in accordance with applicable statutory and

regulatory requirements.

4.1.3 The MRC shall not disclose sensitive and other restricted information regarding safe deposit and

patent deposit in any form as specified by relevant contracts, if any.

4.1.4 When the depositor requests a delay in the publication of the associated data, the MRC shall

enforce an agreed timeframe and conditions, and may release the data into the catalogue after it is

expired.

4.1.5 The catalogues of MRCs shall contain indispensable service information including ordering,

shipping information, and basic template documents such as forms and agreements to comply with

requirements associated with the handling and shipping of microbial materials, which should enable the

efficient use and be user-friendly.

4.1.6 Public data of microbial materials documented in the catalogue of MRCs should be shared

to public databases such as GenBank https:// www .ncbi .nlm .nih .gov/ genbank/ , Global Biodiversity

Information Facility (GBIF) http:// www .gbif .org/ , Catalogue of Global Genome Biodiversity Network

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ISO/FDIS 21710:2020(E)

(GGBN) http:// www .ggbn .org/ ggbn _portal/ , WFCC Global Catalogue of Microorganisms (GCM) http://

gcm .wdcm .org/ , if appropriate.

4.1.7 The online catalogue of MRCs should facilitate search capacity across community databases to

support extensive searches for multiple characteristics of microbial materials and improve diversity of

information.
4.2  Data fields of catalogue

4.2.1 The MRC shall properly arrange an accession form for online submission to deposit a microbial

material and associated data efficiently, and it should apply a machine-readable tabular format, if

applicable.

4.2.2 The MRC should ensure the availability of an MDS, and the MDS should include all the following

data fields given in A.2.1: a) accession number, c) organism type, d) status, e) biosafety and biosecurity, f)

other restrictions, and A.2.2: c) history of deposit. The MRC should select all or part of the optional data

fields according to specific circumstances as specified in Annex A.

4.2.3 The MRC should maintain a high quality and cross-referenced online catalogue to link the data

to publicly available controlled vocabularies specified in Annex A and the authorized databases in

accordance with 4.1.6 and 4.1.7.

4.2.3.1 The MRC should link each name of microbial material with publicly available nomenclature

databases to facilitate data retrieval and accessing. The MRC shall indicate the changes of nomenclature

in the printed catalogues.

4.2.3.2 The MRC should link each sequence (e.g. genomic, metagenome, cDNA, RNA and protein

sequences) to publicly available databases.

4.2.3.3 The MRC should link bibliographic information including digitized literature and patent to

publicly available databases and document the DOI numbers, if applicable.
5  Data management and data quality control
5.1  General
The data management of MRC shall be in accordance with ISO20387: 2018, 7.10.
5.2  Requirements for in-house data management

5.2.1 The MRC shall establish, implement and maintain a data management system to ensure the

essential information is available in the database, e.g. the storage period and location of microbial

materials, frequency of data update and backup, and review and inspection actions for the different

categories of data.

5.2.2 The MRC shall establish and maintain a security system and implement a procedure for the

management of data and related documentation to prevent access by unauthorized users, ensuring

information security, bio-security, protection of Intellectual Property Rights (IPRs) and depositor/user

information.

5.2.3 The MRC shall establish and implement a strategic plan for the sustainability of the in-house

data, especially critical details of operation in the preservation process by regular data quality audit, in

order to fulfil traceability of microbial material and associated data, as well as potential risks.

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ISO/FDIS 21710:2020(E)

5.2.4 The MRC shall establish, document and implement adequate data quality control (QC) procedures

to reduce the risk of data inaccuracy and unexpected loss, in accordance with the QC specified in

ISO20387:2018, 7.8.3., 7.8.2.8, and 7.2.8.9

5.3  Data management for the patent deposit of microbial material and associated data

5.3.1 Patent deposit related information shall be available exclusively to the depositor, and shall by no

means be included in catalogues or any publicly available lists without a prior documented consent of

the depositor.

5.3.2 The MRC may partly disclose patent related information including patent name, patent number

and accession number in accordance with 4.1.2 to facilitate accessing of the patent deposited materials.

5.3.3 The MRC should document the MDS as specified in 4.2.2 and Annex A, 10 c). It should document

the essential information for viability testing and storage in the database.

5.3.4 The MRC shall establish, implement, and document a procedure for the handling of the patent

deposit of microbial material and associated data. It is presupposed that procedures are developed in

accordance with applicable statutory requirements.

NOTE For the parties to the Budapest Treaty, the required documents include the accession form (BP/1),

official notifications to the depositor including the mandatory international form (BP/4), official receipt viability

statements (BP/9) and notification of release to a third party (BP/14).

5.3.5 The MRCs should document major changes of patent deposit including the name of the authorized

representing person, transfer of rights, fate of the culture after the prescribed duration of storage, as well

as the dates when the microbial material was received, returned, accepted, and the date the when it was

validated, stored, renewed, withdrawn and destroyed in the database.
5.4  Data management requirements for the transfer and traceability of microbial
material and associated data

5.4.1 The MRC shall ensure persistent identification of a microbial material and traceability of

associated data in accordance with ISO 20387:2018, 7.5.

5.4.2 The MRC within jurisdiction of a CBD and NP Party shall document the transfer related

information of microbial material and associated data and link it to the related documents (e.g. PIC, IRCC,

MTA or MAT) in the database, and introduce the administrative, technical and research output data in the

catalogue.
a) Administrative data:
1) authorization of sampling and/or utilization (e.g. PIC);
2) scope of use;
3) status of legislation and related regulations;
4) MTAs.
b) Technical data:

1) information about the in situ origin or the source of the microbiological material;

1) Nagoya Protocol (NP) parties are states that are the parties to the Convention on Biological Diversity (CBD)

signed Nagoya Protocol. The details of NP parties can be found in https:// www .cbd .int/ abs/ nagoya ­protocol/

signatories/ .
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ISO/FDIS 21710:2020(E)
2) information about the provider and recipient;

3) information of collecting, including place, date of sampling, name of collector, and substrate;

4) risk assessment of the microbial material including risk group/biohazard level, restrictions on

distribution or safety precautions;
5) taxonomical data and the reference;

6) information necessary to ensure the long-term preservation of the microbial material including

growth temperature, media composition, and specific growth conditions.
c) Research output data:

1) information about modifications and unmodified derivatives of the material and associated data;

2) scientific papers, patents, and any commercial results.
5.5  Unique identifier of microbial material and associated data

5.5.1 The MRC shall implement a unique identifier system in accordance with 5.5.1.2 to ensure efficient

retrieval and access to the microbial material associated data.

NOTE The accession number of the legacy microbial material and associated data can be regarded as a

unique identifier, only if the MRC can confirm its uniqueness among all the publicly available information in the

context of life science and biotechnology. For example, an MRC can combine a unique acronym assigned when it

registered in WDCM CCInfo database (http:// www .wfcc .info/ ccinfo/ ) with its local identifier to form a unique

accession number.

5.5.1.1 The MRC should use and refer to pre-existing persistent identifiers (e.g. DOI) in priority.

NOTE Globally unique identifiers assigned by authoritative international organization (e.g. WDCM) and/or

schemes can serve as persistent identifiers in the MRCs.

5.5.1.2 Unique identifiers shall be implemented, documented and maintained in accordance with

ISO 20387:2018, 7.5.1 a).

5.5.2 The MRC shall issue a unique identifier in accordance with 5.5.1.2 to a microbial material at

the time of deposit, and it shall take a long-term view to decide the scope and life cycle of data and the

identifiers they have issued.

5.5.3 The MRC should document the procedure for assigning and maintaining the unique identifiers.

5.5.3.1 The change history of a unique identifier issued by the MRC shall be documented and/or

retrievable.
5.5.3.
...

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