Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

The EPA plans to regulate these materials under the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA").  Howard Lovy from NanoBot questions whether the EPA is really breaking new ground in its regulation, since it already regulates the use of silver as an anti-microbial agent. 

As always, I imagine, the devil is in the details.  While EPA might already regulate silver under FIFRA, it probably will not apply the same regulatory standards to "nano-silver."  It will be interesting to see how much safety testing EPA requires "nano-silver" manufacturers to use, and whether those manufacturers will conduct the testing necessary to pass muster (or whether they will simply abandon the project).  I'm reminded of the issue of OSHA regulation of nanomaterials:   only a few years back, manufacturers of carbon nanotubes were submitting MSDSs that were essentially the same as for graphite (which is used to make the nanotubes). 

Jonathan Adler of Case Law School and the Volokh Conspiracy emphasizes that the new regulations will only apply to companies that make germ-killing claims in connection with the marketing of  nano silver-containing products.

The essence of Taylor's report is distilled in Table 2 on page 27 of the article, in a table entitled “Capacity of FDA’s Legal Authority to Achieve the Primary Goals of Regulatory Oversight for Nanotechnology Products.” The table provides a quick summary of how Taylor views the FDA’s current power to regulate the nanotechnology industry.

Specifically, Taylor identiies four FDA Pre-Market Oversight Goals:
1. Obtain information on new nanoproducts early in the development process;
2. “Define and enforce public safety standards for nano-materials, including the nature and extent of testing required to satisfy them;”
3. “Place the initial and continuing burden to demonstrate safety on the nanotechnology product’s sponsor;” and
4. “Review the nanotechnology product’s safety prior to marketing and improve conditions as needed to ensure safety.”

And four FDA Post-Market Oversight Goals:
1. “Require post-marketing monitoring and testing of nanotechnology products as needed to ensure safety;”
2. “Require timely adverse event reporting;”
3. “Inspect manufacturing establishments and examine records related to nanotechnology product safety;” and
4. “Remove from the market nanotechnology products that appear to pose a significant safety hazard and or no longer meet the applicable safety standard.” 

Taylor then evaluates what he perceives to be the effectiveness of FDA’s current authority to implement these goals across nine different product categories: Cosmetics, Whole Foods, Dietary Supplements, GRAS Food Ingredients, Food Additives, Food Packaging, Medical Devices, OTC Drugs, and New Drugs.

Medical Devices and New Drugs fare best under Taylor’s analysis, while Cosmetics, Whole Foods, and Dietary Supplements fall at the other end of his spectrum. Taylor’s analysis suggests, however, that virtually every product category could benefit from a strengthening of FDA’s existing regulatory authority.

Taylor further implies that FDA will not be able to reach the above-referenced goals unless Congress drastically increases its funding. To this end, Taylor asserts FDA’s 2007 budget falls 56% short of what it needs to perform the same tasks required of it in 1996.

The report concludes with helpful information concerning FDA’s existing nanotechnology activities, additional tools Taylor believes FDA needs to do its job, and several recommendations regarding how FDA should approach the significant gaps in the nano-regulatory picture he paints.

“Regulating the Products of Nanotechnology: Does FDA Have the Tools it Needs?,” Taylor, M., Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, October, 2006.