Regulatory Focus™ > News Articles > OECD Takes a Stab at Redefining Biotechnology and Nanotechnology

OECD Takes a Stab at Redefining Biotechnology and Nanotechnology

Posted 24 January 2018 | By Zachary Brennan 

OECD Takes a Stab at Redefining Biotechnology and Nanotechnology

As a way to take into account the latest advances in biotechnology and nanotechnology, the Organization for Economic Co-operation and Development (OECD) is proposing to update the statistical definitions of both terms.

But why does it matter that there are official definitions for the terms? And why do they need to be updated?

The OECD explains that the statistical definitions proposed help to support statistical surveys and can provide a basis for future data collection that allows linking between technology development, use, innovation and economic impact.

OECD’s proposal, released last week, seeks to revise the statistical definition of biotechnology, which had last been reviewed in 2008, and proposes the adoption of a statistical definition of nanotechnology in the same format.

Background

Biotechnology, OECD says, is considered to have started in the 1970s with the first gene-splicing and transfer experiments.

“Enabled by modern molecular biology, the field of biotechnology is closely linked to biological sciences and fundamentally reliant on the involvement of biological material and systems in a technical process or application for it to be called ‘biotechnology,’” the proposal says.

Nanotechnology, however, “is delineated only in that the underlying nanotechnology-based processes and applications are based on phenomena occurring on the nanometre scale (i.e. 1 and 100 billionth of a metre), independent of the materials involved or the scientific disciplines applied.”

Modern nanotechnology is said to have commenced around the start of the 2000s, enabled by the invention of the scanning tunneling microscope in 1981.

Updates

OECD says it’s updating biotechnology and nanotechnology definitions “to take into account the latest advances” in both fields, which includes CRISPR-Cas9 gene editing and increased research and development activity on graphene.

Proposed additions to list-based statistical definitions include: large-scale DNA synthesis, genome- and gene-editing, gene drive, marker assisted breeding technologies, metabolic engineering, biosensing and biorefining.

“The list is indicative rather than exhaustive and is expected to change over time as data collection and biotechnology activities evolve. The list-based statistical definition does not imply a classification comprising mutually exclusive sub-domains of biotechnology,” OECD says.

OECD also proposes updating the list of patent symbols identifying biotechnology patents. This list includes, “Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells (uncharacterised stem cells; vaccines or medicinal preparations containing antigens or antibodies),” among other additions.

OECD’s proposed statistical definition for nanotechnology is, “The understanding of processes and phenomena and the application of science and technology to organisms, organic and inorganic materials, as well as parts, products and models thereof, at the nanometre-scale (but not exclusively below 100 nanometres) in one or more dimensions, where the onset of size-dependent phenomena usually enables novel applications. These applications utilise the properties of nanoscale materials that differ from the properties of individual atoms, molecules, and bulk matter for the production of knowledge, goods and services, like improved materials, devices, and systems that exploit these new properties.”

The proposal also features a list-based statistical definition of nanotechnology featuring terms such as nanomaterial and nanomedicine.

Revised proposal for the revision of the statistical definitions of biotechnology and nanotechnology

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