Recent Introduction of the Nanotechnology Safety Act of 2010 (Senate Bill S. 2942)
On January 21, 2010, U.S. Senators Pryor and Cardin introduced the Nanotechnology Safety Act of 2010 (Senate Bill S. 2942). The bill would establish a program within the Food and Drug Administration (FDA) for the scientific investigation of the health and safety of nanoscale materials that are included or intended for inclusion in FDA-regulated products.
There are over 600 known commercial uses of nanotechnology. Nanoscale materials are included in a variety of FDA-regulated products including drug delivery systems, medical devices, orthopedic implants, cosmetics, and food additives. Nanoscale materials often have novel characteristics compared to ordinary materials. Risk assessments developed for ordinary materials are of potentially limited use in determining the health and public safety of products including nanoscale materials.
The goal of the program to be established by the bill is to provide the FDA with the tools and resources necessary to develop a robust scientific framework for assessing the safety and effectiveness of the inclusion of nanoscale materials in FDA-regulated products. This scientific framework would also aid the FDA in developing a regulatory framework for reviewing and approving the use of nanoscale materials in FDA-regulated products.
The bill authorizes $25 million each year from 2011 through 2015 in support of the program. The FDA has already devoted some resources to understanding the health and safety of nanoscale materials, and has established the Nanotechnology Core Facility at the National Center for Toxicological Research in Jefferson, AR. According to Senator Pryor, this facility as well as the FDA’s consolidated headquarters in White Oak, Maryland, both could be utilized to conduct the scientific studies required under the bill.
Innovator companies and universities may consider development of methods for testing the safety and efficacy of nanoscale materials that could later become a part of a regulatory framework for the use and inclusion of nanoscale materials in FDA-regulated products.
As the bill proceeds through the legislative process its provisions may change, and if passed into law the implementing provisions put in place by the FDA may reflect additional opportunities for capitalizing on inventions relating to nanotechnology.