Nanotechnology, which has widespread applications in various spheres such as electronics, food, health care products, personal products, pharmaceutical products and textiles has come under the scanner of the U.S. Food and Drug Administration which has planned to launch a series of studies into the possible risks involved in nanotechnology.
Noted environmental attorney and partner at Newark based Tort Defense Practice, James A. Kosch, has authored a column on this topic at the website www.CorporateComplianceInsights.com. Kosch, who appears to be in favor of the FDA’s move, highlights the aspects of the two regulatory guidelines released by the FDA in April 2012. The nonbinding guidelines propose further research into the effect of exposure to nano materials on the cells. This comprises toxicology tests at various levels of exposure, in vitro and in vivo studies and dermal penetration. In a move that is considered to be non-customary of Regulatory guidelines, the FDA has invited manufacturers and sellers of nano based products to volunteer information to aid the research.
Kosch states that the move should not be considered retrogressive but as an opportunity to eliminate the uncertainties clouding this technology. The properties of materials at nano sizes may differ significantly from those at macro sizes. Added to this is the confusion caused by contradictory proclamations from different quarters such as the potential harm caused by the use of nano scale titanium dioxide in sunscreens. There is also ambiguity over regulatory jurisdiction between the FDA and FIFRA [The Federal Insecticide, Fungicide and Rodenticide Act]particularly in the case of micro bodies released into the environment by nano particles. Cooperating with the Regulators is bound not to be detrimental but would in fact pave the way for advancement in nanotechnology.