nano technology compliance

Under The Electron Microscope: Agencies Take A Closer Look At Nano Tech

nano technology compliance

The development of manufactured materials at the nano scale (that is less than 1/10,000 of the width of a human hair) has been greeted as a breakthrough in the evolution of technology with vast promises for medicine, energy and building materials to mention just a few areas where exciting improvements are just around the corner. Nanotechnology is being hailed as a possible savior of the U.S. manufacturing sector and as a plausible means of environmental improvements such as waste-minimization and site-remediation.

Nano materials are already in everyday use in consumer products ranging from tennis rackets to sunscreens and bactericides. Nanotechnologies are not without their critics, but to date, the uproar from the “usual suspects” has been mild compared to, say, the opponents of genetically modified foods. Moreover, regulatory agencies in the United States, especially the EPA and the FDA, have so far taken prudent positions in this area.

Generally, nano materials involve the use of metals, carbon and chemicals with which we are already familiar and which have long been subject to study and regulation under the likes of the Toxic Substance Control Act or the Food and Drug Act. However, the chemical and physical properties of materials at the nano scale can differ significantly from those at the macroscopic scale, and today the ultimate effects of “the smallest of the small” on human health and/or the environment are simply not well studied or known.

Take the controversy over the unknown, long-term effects of sunscreens that use nano-scale titanium dioxide, which makes it possible for these products to be clear rather than white. “Titanium dioxide has the ability to cause DNA damage in human cells, and there is concern that it may be carcinogenic,” warns one health and wellness website. But others, citing various studies, assert that titanium dioxide is basically safe.

And there are regulatory uncertainties as well. Should silver nano materials, when dispersed into the environment as bactericides and micro biocides, be subject to regulation under FIFRA? To date, in fact, most regulation of nano materials has focused on the question of whether these products are covered by the existing regulatory regime. If not, new regulations are required.

A step forward took place on April 20 when the FDA issued two nonbinding draft guidances on this issue (the first with an almost impossibly long title): Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives and Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.

The guidances reflect the growing understanding of how nano materials may be absorbed into the human body and affect human health. They describe how exposure to nano materials may effect cells or systems and note that those effects need to be studied. The FDA has not called for wide-scale bans or restrictions, but rather a collaborative recommendation that studies be conducted of nano materials used in FDA-regulated consumer products or food substances. This would include more study (up to and including clinical studies) of the effects of nano materials, including toxicity testing at various exposure levels; dose studies in vitro and in vivo, and further examination of dermal modes of exposure such as dermal penetration, irritation and sensitization.

The FDA suggests that companies manufacturing and selling such products should meet and confer with the agency to start sharing information and develop this research. Such collaboration is hardly the norm in the regulatory sphere. This approach is a sound one by a regulatory agency, and responsible companies should heed the invitation and cooperate with the FDA and others seeking to add to the body of knowledge about these products and to figure out how to make them as safe as possible, while still protecting trade and business secrets. The forward-thinking company is probably already having these discussions and looking at related areas such as workplace exposure, waste disposal from production, lifecycle concerns and consumer disposal.

While these technologies are the smallest of the small, their potential benefits are large indeed. Futurists may fret about the likes of nano robots running wild, but so far there are no Three Mile Islands or Love Canals marring the history of this field. Nor are nano technologies being stymied by draconian regulations. By acting in good faith and collaborating with these agencies, the industry could help keep it that way.

About the Author

James A. Kosch

James Kosch, LeClairRyanAbout the Author

Attorney James A. Kosch is a Newark, NJ -based shareholder in LeClairRyan’s Tort Defense Practice and a director of the New Jersey State Bar Association’s environmental law section.