Medical Device Daily National Editor

The FDA has indicated in its pronouncements to date that we're not to worry concerning the possible risks of nanotechnology products. Most of its statements on the subject have tended to assure that its regulatory processes are equal to the task of understanding, tracking and avoidance of potential hazards.

And at an agency meeting earlier this year to gather industry input on the subject produced no particular feedback or alarms concerning issues of safety (Medical Device Daily, April 30, 2008).

But recent research conducted by the National Institute of Standards and Technology (NIST) indicates the possibility of significant health problems, at least from free-floating nanoparticles of the smallest size.

It has found that an abundance of "ultrafine" particles can be emitted from common household appliances, such as stoves and toaster ovens, with the possibility of causing injury to pulmonary and cardiovascular health.

And in another initiative on nanotechnology the organization is working to establish an Internet portal that will help to establish needed standards for development of new products incorporating nanotechnology.

To measure small nanoparticles in enclosed spaces, NIST has developed a test house which is equipped to measure ventilation rates, environmental conditions and the concentration of particles and said it found quantities of nanoparticles of the very smallest sort, from 2 nanometers to 10 nanometers, emitted by household appliances. This compares to previous measurement technology it used, able to detect – and finding – nanoparticles of the larger sizes.

NIST says that these ultra-fine particles (UFP) are emitted by motor vehicles and a variety of indoor sources, and "have attracted attention" as the result of evidence that they can cause respiratory and cardiovascular illnesses.

The NIST researchers conducted a series of 150 experiments and found these smaller nano-sized particles from gas and electric stoves and electric toaster ovens. It also expressed concern about the use of small appliances such as hair dryers, steam irons and electric power tools that include heating elements or motors that may produce UFP. It noted that these appliances are often used "at close range for relatively long times, so exposure could be large even if the emissions are low."

NIST said that its research should help to develop future studies exploring how these particulates impact human health.

In another initiative launched by NIST, it reported work to assist in the development of future nanotechnology products, in collaboration with other governmental groups and industry scientists. The effort is to create an online community to speed what it terms "critically needed nanotechnology standards."

NIST cites estimates from the market research firm Lux Researchprojects (New York) that the entire nanotechnology sector will expand from $147 billion in 2007 to a worldwide market of $3 trillion a year. But it says that the establishment of the required standards for developing these products has not kept up with the sector's rapid development.

The initiative, it said, will help to establish "the underpinning reference materials and tests that support development of nanotech products, while minimizing potential risks."

NIST describes the proposed initiative as an "Internet-linked community of interest" that will use social networking technologies that enable the creation, sharing and archiving of information concerning the latest developments in nanotechnology research and product development."

It said that the collaboration will focus creating important nanotechnology standards for biomedical and health applications, including standard reference materials and test methods. It said that the site will provide the opportunity for researchers to discuss and debate "technical details of in-process standards."

The site, NIST said, will focus first on creating the standards for characterizing the structure and properties of engineered materials at the nanoscale level, those "with at least one feature measuring between 1 nm and 100 nm.

A prototype of this collaborative website – termed a wiki – was presented and demonstrated by the Advanced Biomedical Computing Center of the National Cancer Institute (NCI) at a recent international workshop hosted by NIST, and received a strong endorsement from participants.

Piotr Grodzinski, director of NCI's Alliance for Nanotechnology in Cancer, said, "The lack of standardized methods has been a rate-limiting step in the translation of nanoparticle-based cancer therapies. I commend this initiative for taking on [the work of] streamlining nanomaterial characterization and its standardization."

According to NIST, researchers attending this workshop noted the development of standards for nanotechnology but that the guidance for these efforts has not been "as effective or as coherent as the global challenge requires."

NCI is continuing to develop the site with the expectation that it will be launched some time early next year.

NIST said that NCI is in the process of developing the site by adding features that will enable rapid dissemination of drafts, discussions, votes and supporting materials concerning nanotechnology standards.

These tools, NIST said, "will help in organizing discussions, and standards developing organizations will be able to tap this resource to expedite drafting and validating protocols before they enter the formal approval process."

Besides NCI, other co-sponsors of the new site listed by NIST are FDA, the National Institute of Environmental Health Sciences, the National Institute for Occupational Safety and Health, the Oregon Nanoscience and Microtechnologies Institute (Corvallis), the Nanotechnology Characterization Laboratory (Frederick, Maryland), along with contributions from ASTM International (West Conshohocken, Pennsylvania).