In Washington, ASTM International’s industrial biotechnology committee (E62) is developing a proposed standard (soon to be published as E3214) that will help classify microorganisms. 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.
“The designation of microbe-based products as either genetically modified organisms (GMOs) or not is too simplistic,” said ASTM International member Joseph McAuliffe, senior principal scientist at DuPont Industrial Biosciences. “This standard will give customers of the biotechnology industry, the general public, and regulators more information on the composition and intended uses for a given product.”
As worded in the Scope for the proposed classification, 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).
ASTM is at pains not to comment on the ethics of genetic engineering, adding that “ASTM 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.”
According to McAuliffe, the proposed standard will help biotech industry customers compare product options while also helping regulators determine how to classify new types of microbial products.
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