ASTM E3214-19
(Classification)Standard Classification for Industrial Microorganisms
Standard Classification for Industrial Microorganisms
SIGNIFICANCE AND USE
4.1 The technology to engineer industrial microorganisms (IMs) is evolving rapidly and the public, regulatory bodies, and industrial sectors require new tools to help evaluate the products of biotechnology (1)3. In particular, there is a need to clarify the nature and intent of genetic alterations present in many industrial microbial strains (2, 3).
4.2 Currently, there is no systematic classification system to help differentiate among the many subtypes of engineered industrial microorganisms (4, 5). In response, a classification system for industrial microorganisms has been developed with the intent of facilitating the commercial use and development of industrial microorganisms and the biotechnology sector in general.
4.3 This classification will be applied to all microorganisms for which there is an intended use, broadly referred to as “industrial microorganisms.” This classification covers both viable and non-viable microorganisms, in addition to any product that contains microbial DNA.
4.4 This classification is not intended to apply to downstream products of industrial microorganisms that do not contain microbial DNA, for example, highly purified proteins or small molecules produced by industrial microorganisms.
SCOPE
1.1 This classification applies to all industrial microorganisms, both classically derived and those produced through genetic engineering methods.
1.2 The scope of this classification does not include plants and animals. This classification would not be applied to any downstream products derived from industrial microorganisms unless they contain microbial deoxyribonucleic acid (DNA).
1.3 This classification includes fields for genotype class, biosafety, mode/intent of use, and the extent of DNA sequence information for a given industrial microbial strain.
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
Relations
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation:E3214 −19
Standard Classification for
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Industrial Microorganisms
This standard is issued under the fixed designation E3214; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2 Definitions of Terms Specific to This Standard:
3.2.1 genotype, n—portion of genetic material within an
1.1 This classification applies to all industrial
organism that determines the expression of a specific charac-
microorganisms, both classically derived and those produced
teristic (phenotype).
through genetic engineering methods.
3.2.2 mutagenesis, n—addition, deletion, or substitution of
1.2 The scope of this classification does not include plants
at least one base within an organism’s genome.
and animals. This classification would not be applied to any
3.2.2.1 Discussion—Mutagenesis can occur under either
downstream products derived from industrial microorganisms
natural or directed means.
unless they contain microbial deoxyribonucleic acid (DNA).
3.2.3 native deoxyribonucleic acid (DNA), n—DNA se-
1.3 This classification includes fields for genotype class,
quences derived from within the same microbial species
biosafety, mode/intent of use, and the extent of DNAsequence
3.2.4 non-native DNA, n—DNAsequences originating from
information for a given industrial microbial strain.
other microbial species or designed sequences with three or
1.4 Units—The values stated in SI units are to be regarded
more intentional and predesignated DNA base-pair alterations
as standard. No other units of measurement are included in this
across a genome, relative to native DNA.
standard.
3.2.4.1 Discussion—Non-native DNA shall fall outside the
1.5 This standard does not purport to address all of the
observed genomic diversity within a given microbial species.
safety concerns, if any, associated with its use. It is the
DNA base-pair alterations are defined as either base-pair
responsibility of the user of this standard to establish appro-
insertions, or substitutions, but not deletions.
priate safety, health, and environmental practices and deter-
3.2.5 transgenic, adj—organism that contains non-native
mine the applicability of regulatory limitations prior to use.
DNA sequences.
1.6 This international standard was developed in accor-
3.2.5.1 Discussion—Non-native DNAsequences can be de-
dance with internationally recognized principles on standard-
rived from another species or designed de novo.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
4. Significance and Use
mendations issued by the World Trade Organization Technical
4.1 The technology to engineer industrial microorganisms
Barriers to Trade (TBT) Committee.
(IMs)isevolvingrapidlyandthepublic,regulatorybodies,and
industrial sectors require new tools to help evaluate the
2. Referenced Documents
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products of biotechnology (1) . In particular, there is a need to
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2.1 ASTM Standards:
clarify the nature and intent of genetic alterations present in
E3072 Terminology for Industrial Biotechnology
many industrial microbial strains (2, 3).
4.2 Currently, there is no systematic classification system to
3. Terminology
help differentiate among the many subtypes of engineered
3.1 Definitions—See Terminology E3072 for industrial bio-
industrial microorganisms (4, 5). In response, a classification
technology terms.
system for industrial microorganisms has been developed with
the intent of facilitating the commercial use and development
of industrial microorganisms and the biotechnology sector in
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This classification is under the jurisdiction of ASTM Committee E62 on
general.
Industrial Biotechnology and Synthetic Biology and is the direct responsibility of
Subcommittee E62.02 on Best Practices.
4.3 This classification will be applied to all microorganisms
Current edition approved June 1, 2019. Published July 2019. DOI: 10.1520/
for which there is an intended use, broadly referred to as
E3214.
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
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Standards volume information, refer to the standard’s Document Summary page on The boldface numbers in parentheses refer to a list of references at the end of
the ASTM website. this standard.
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