ASTM E3214:19 pdf download

ASTM E3214:2019 pdf download.Standard Classification for lndustrial Microorganisms.
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.
5. 5. Basis of Classification
5.1 This classihcation consists of four fields that represent genotype class. biosafety risk grouping. mode/intent ol’ usc. and the extent of gcnomc sequence information.
5.2 Field I rekrs to genotype class and is assigned to one of four categories (A-D). Classes A-C are organisms that only contain or produce naturally observed biochcmicals regardless of the origin of [)NA sequences contained within the strain. Classes A-C are also referred to as Type I microorganisms. In contrast. Class D organisms contain or produce chemical entities not previously observed in nature, for example, non. natural amino acids or pharmaceuticals produced through engineered biochemical pathways (6). Class D organisms are also referred to as Type 2 microorganisms.
5.2.1 Class A organisms are defined as native strains in which no intentional selection or engineering was applied with the intent of creating a new phenotype. Class A strains include microorganisms present in the environment, as well as natural isolates and laboratory propagated strains derived from natural isolates. Class A organisms may be subject to unintentional selection pressures that may lead to spontaneous genetic changes, for example. those driven by changes to the natural environment or through propagation under laboratory conditions. Examples of Class A strains include wild yeasts used in brewing, the human microbiomc. microorganisms present in the soil, and naturally-occurring pathogens.
5.2.2 Class B organisms are defined as strains that have been subjected to deliberate alteration of the organism’s native gcnome without the introduction of any non-native DNA. with the intent of producing an altered phenotype. Any form of selective pressure or genetic engineering can be applied provided the genomic sequence of the resulting strains falls within the bounds of the known genetic diversity of the parent microbial species. The definition of microbial species is adopted from Parker. Tindall. and Garrity (7). The origin of native DNA can be natural or synthetic provided the sequence is within the observed native genomic diversity as determined by DNA sequencing.
5.2.3 Class C organisms are defined as strains that have been subjected to intentional selection or engineering with addition of non-native DNA. For the purposes of this classification, non-native DNA is defined as DNA sequences originating from other species or designed DNA sequences with three or more intentional base-pair alterations relative to an otherwise homologous native DNA sequence. By definition. non-native DNA shall fall outside of the observed genomic diversity of a given microbial species as determined by DNA sequencing. Class C organisms arc typically produced through modern genetic techniques involving recombinant or synthetic DNA sequences.