This column is a follow-up to the excellent article by Barry Bark, Ph.D., and Dr. Steffi Friedrichs in the April issue of Controlled Environments Magazine titled “ Safe Nanotechnology: Overcoming Challenges and Assessing Risk in Bringing Applications to Market.” That article focused on the absence of published guidance on the handling and disposal of nanoparticles and other nanoscale entities, and assessment of the risks associated with development and use of nanomaterials. This column will report on a significant step in U.S. management of nanomaterials—a role for the U.S. Food and Drug Administration (FDA), and probably raise more questions than it answers.

YOUR GOVERNMENT IN ACTION
While that subtitle may be an oxymoron, there are at least four U.S. governmental organizations whose status relative to nanomaterials is somewhere between “cognizant of,” “working with,” and “responsible for.”

U.S. National Institute of Occupational Safety & Health (NIOSH) reports that “NIOSH has field teams out to start trying to assess plant processes and types of exposures. As of now, exposures to bulk nanomaterials appear to be quite low…”

But since a primary characteristic of nanomaterials is their size and huge surface area, that level of scrutiny may not be adequate. Screening for bulk materials is likely to miss nanoscale materials.

The U.S. Environmental Protection Agency (EPA) enforces the Toxic Substances Control Act (TOSCA), which regulates new chemicals in commerce. But, particle size is not a characteristic of their identification of a new chemical specie.

The National Cancer Institute (NCOI) wants to study drugs based on nanoscale materials because of the huge surface area of these materials, and thus their potential for imparting specially-functionalized surfaces to cancerous cells. But, we have much to learn as NCI notes “It is a daily occurrence in our labs that one of our standard assays doesn't work because of the unusual properties of these materials…”

The FDA wants to be a major, perhaps the major, player in management of nanoscale materials.¹ In a sense, FDA’s mandate is to manage exposure to toxicity in foods, cosmetics, packaging, pharmaceuticals, and biomaterials. If national concern about nanomaterials is unanticipated toxicity, who better to manage that says FDA.