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.