1.1 The genetic classification system for industrial microorganisms (GCSIM) would categorize industrial microorganisms (IMs) based primarily on their genotype [that is, their deoxyribonucleic acid (DNA) sequence], with a lesser emphasis placed upon the techniques used to generate them. Both the source and nature of any genetic modifications would be used to differentiate between IMs and allow subclassification of strains currently grouped together and designated as genetically modified microorganisms (GMMs). In addition, IMs derived from natural isolates or classical selection methods might also be subdivided as a function of their genetic composition. Methods for generating genetic modifications, whether classical or through modern genetic engineering techniques, might be considered as part of the classification system, especially where there is the possibility that such methods could introduce genetic or epigenetic modifications beyond the intended changes. 1.2 Downstream products derived from IMs that do not contain genetic material (that is, purified enzymes and products thereof) are not included within the scope of the GCSIM. Higher organisms, including plants and animals are also not included within the scope of the GCSIM. Standards for ensuring the absence of genetic material in downstream products are defined separately. 1.3 DisclaimerASTM Committee E62 and the subcommittee to be responsible for this work stream will take no position on the ethics of modern genetic engineering technologies, the safety of engineered industrial microorganisms or derived products, or their overall impact on society at large. The goal of the classification system described in this classification is to provide a deeper level of categorization beyond simply whether a given industrial microorganism is a genetically modified organism (GMO) or not. Our assumption is that such a system could help guide emerging regulatory efforts and policy with regard to industrial microorganisms and their commercial applications. 1.4This 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 and health practices and determine the applicability of regulatory limitations prior to use.
Keywordsgenetic classification system for industrial microorganisms; genotype; industrial microorganism
There is the need for a classification system to provide a simple, standardized nomenclature that allows differentiation between the various subtypes of industrial microorganism based primarily upon their genetic composition.Back to Top