New Practice for Design, Production, and Deployment of Genetically Engineered Microorganisms
1. Scope
The standard practice will provide formal guidance on DNA design safety for GEMS released into the open environment, regardless of whether this is intentional or accidental. The standard will highlight genes of concern that should be avoided in microbe design, such as antibiotic resistance markers and virulence genes, in addition to other genetic elements that might facilitate the transfer of such genes. In addition, the guide will identify other phenotypic characteristics that must be considered, including mutation rate, competence and similarity to wild-type microorganisms present in the environment. The potential for extended ecological impact of GEMs engineered to produce chemicals, biofuels, pharmaceuticals, enzymes and other bio-derived molecules will be specifically addressed.
Genetically engineered microbes (GEMs) are different from other genetically modified organisms (such as plants) with regard to evolution rate, spread rate, spread distance, complexity of ecosystem interactions, probability of survival, ability to uptake or share DNA and potential to overproduce proteins, secondary metabolites, biofuels and other chemicals. This implies that GEMs have unique safety concerns that should be addressed separately from traditional higher organism GMOs. Accordingly, a standard practice for the design, manufacture and use of genetically engineered microorganisms (GEMs) is needed in order to provide strategies, guidelines and recommendations to minimize the potential risks posed by GEMs following either deliberate or accidental release.
