ASTM develops new standard for GMOs

International standards organisation ASTM International is developing a new standard to classify microorganisms aimed at giving more detailed information beyond whether they are genetically modified (GM) or not.

The proposed standard, being developed by ASTM’s industrial biotechnology committee, would soon be published as E3214, the organisation said on 25 June.

“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.”

The genetic classification system for industrial microorganisms (GCSIM) would categorise industrial microorganisms (IMs) based primarily on their genotype (their deoxyribonucleic acid [DNA] sequence), with less emphasis on 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).

The standard does not cover higher organisms, including plants and animals, and downstream products derived from IMs that do not contain genetic material (purified enzymes and their products).

ASTM said it could not 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.”

McAuliffe said the proposed standard would help biotech industry customers compare product options while also helping regulators determine how to classify new types of microbial products.

“Our assumption is that such a system could help guide emerging regulatory efforts and policy with regard to industrial microorganisms and their commercial applications,” ASTM said. “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 and health practices and determine the applicability of regulatory limitations prior to use.”