Commenting on the Food and Drug Administration’s (FDA’s) “Draft Guidance for Industry on Principles for Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” biotech industry interests asked the agency to clarify whether it intends to require “additional safety reviews or environmental or occupational safety and health assessments” by stating that some nanotech products “may merit examination.” Additional information about the draft guidance appears in Issue 15 of this Bulletin.

The Biotechnology Industry Organization’s (BIO’s) comment also seeks clarity on “what counts as a product involving the application of nanotechnology, and how the Draft Guidance should be interpreted with respect to pharmaceuticals in particular.” The BIO comment further calls for the guidance document to address, as “critically important to evaluation of nanotechnology based products,” matters such as delivery route, particle size instrumentation, agglomerates and aggregates, and inert materials. The main theme of BIO’s comment is that because nanomaterial science “has been around for decades, . . . just because a product is considered to be ‘nanotechnology derived material’ or ‘nanosized material’ should not imply potential harm or risk.”  

In a related development, nanotechnology researchers are currently debating whether governments should define what constitutes an engineered nanomaterial for regulatory purposes. Andrew Maynard, a former research physicist who now directs the Risk Science Center at the University of Michigan School of Public Health, opines on his blog 2020 Science that definitions are desired by policy makers “scrambling to use science to justify a predetermined conclusion— that engineered nanomaterials should be regulated on the basis of a hard and fast definition—rather than using science to guide their actions.”

Maynard was responding to comments published in a recent issue of Nature by Hermann Stamm of the European Commission Joint Research Centre Institute for Health and Consumer Protection, calling for a definition for labeling and classification purposes and to decide whether safety assessments may be necessary. Stamm also apparently claimed that engineered nanomaterials are heterogeneous.

Maynard suggests that policy makers “put aside preconceptions” and instead ask “how new generations of sophisticated (or advanced) materials interact with biological systems; where these interactions have the potential to cause harm in ways not captured within current regulatory frameworks; and how these frameworks can be adapted or altered to ensure that an increasing number of unusual substances are developed and used as safely as possible—no matter what label or ‘brand’ is applied to them.” See 2020 Science, September 6, 2011.