In the News

Proposed Bill Would Establish FDA Nanotechnology Risk Assessment Program

Feb 18, 2010

The Nanotechnology Safety Act of 2010 was introduced in the U.S. Senate by Senators Mark Pryor (D-Ark.) and Benjamin Cardin (D-Md.) on January 21, 2010. The bill, S. 2942, would amend the Federal Food, Drug, and Cosmetic Act to require the establishment of a program within the Food and Drug Administration (FDA) for the scientific investigation of nanoscale materials included or intended for inclusion in FDA-regulated products.

The bill mandates specific goals for the nanotechnology program, including: assess scientific literature; develop and organize information using databases and models; promote and participate in collaborative efforts; build scientific expertise; and participate in international and national consensus standards activities. A program manager would be responsible for developing a strategic plan for achieving short- and long-term technical goals. FDA would be required to report on the program to Congress no later than March 1, 2012 and March 1, 2014.

The Nanotechnology Safety Act authorizes $25 million for the nanotechnology program each year from 2011 through 2015. In a press release on the Act, Pryor pointed out that the scientific studies required under the bill could be conducted at FDA's National Center for Toxicological Research (NCTR) in Jefferson, Ark., or at the Agency's headquarters in White Oak, Md.

"Nanotechnology holds great promise to revolutionize the development of new medicines, drug delivery, and orthopedic implants while holding down the cost of health care," Pryor stated when introducing the legislation. "The development of a regulatory framework for the use of nanomaterials in drugs, medical devices, and food additives must be based on scientific knowledge and data about each specific technology and product. Without a robust scientific framework there is no way to know what data to collect," he added.