The Nanotechnology Safety Act of 2010

On Thursday 01/21/2010, Senator Mark Pryor (D-Ark) introduced S. 2942, "The Nanotechnology Safety Act of 2010", the first nanotechnology related bill of the 2nd session of the 111th Congress. The bill is co-sponsored by Senator Benjamin Cardin (D-MD). The text of S. 2942 has not yet been made available by the Government Printing Office; the link above is to Senator Pryor's introductory remarks in the Congressional Record. The text of S. 2942 as introduced follows the Senator's remarks.

In his introductory remarks Senator Pryor stated that the bill would "authorize a program of scientific investigation by the Food and Drug Administration on nanotechnology based medical and health products . . . . [to] enable the FDA to properly study how nanomaterials are absorbed by the human body, how nanomaterials designed to carry cancer fighting drugs target and kill tumors, and how nanoscale texturing of bone implants can make a stronger joint and reduce the threat of infection."

Senator Pryor also noted in his remarks that

The FDA needs the tools and resources to assure the public that nanotechnology-based medical and health products are safe and effective. 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. More than a dozen material characteristics have been suggested even for relatively simple nanomaterials. Without better scientific knowledge of nanomaterials and their behavior in the human body, we do not know what data to collect and examine.

. . . the Nanotechnology Safety Act of 2010 will provide the FDA the authority necessary to scientifically study the safety and effectiveness of nanotechnology-based drugs, delivery systems, medical devices, orthopedic implants, cosmetics, and food additives regulated by the agency. This bill is a sound investment on the promise of nanotechnology to improve human health and reduce costs in the 21st Century.

The Nanotechnology Safety Act of 2010 would amend Chapter X of the Federal Food, Drug and Cosmetic Act  by adding section 1011. There would be three major parts to this new section.

Part 1 would establish a program within the FDA to investigate

(A)nanomaterials included or intended to be included in products regulated by the FDA

(B) the potential toxicity of such nanomaterials

(C) the effects of nanomaterials on biological systems

(D) the interaction of nanomaterials with biological systems.

S.2942 would also establish that the new program's purpose would include (1) assessment of the scientific literature and data on the general interaction of nanomaterials with biological systems and on specific nanomaterials of concern to the FDA (2) develop and organize information using databases and models that would enable the formation of general principles about the behavior of classes of nanomaterials with biological systems (3) promote collaborative efforts to understand the properties of nanomaterials that might contribute to possible toxicity (4) promote and participate in collaborative efforts at measurement and detection of nanomaterials (5) collect, interpret and make available scientific information and data about the interaction of nanomaterials and biological systems (6) build scientific expertise on nanomaterials (7) insure ongoing training and dissemination of new information (8) encourage FDA participation in international and national standards activities and (9) carrying out other activities that the Secretary of Health & Human Services (HHS) determines are necessary.

Part 2 of the new section, "Program Administration"  would create the position of a program manager. The position's duties would include developing "a detailed strategic plan for achieving specific short and long term technical goals . . . .", co-ordinate and integrate the strategic plan with investments from FDA and other agencies and departments that participate in the National Nanotechnology Initiative (NNI) and the development of the legal instruments (Memorandums of Understanding, etc) for cooperative arrangements necessary for meeting the long term goals of the program.

Part 2 would also require the Secretary of HHS to submit reports by 03/01/2011 and 03/01/2014 to the House and Senate Appropriations Committees, the Senate Health, Education, Labor and Pensions Committee and the House Committee on Energy and Commerce. The reports would review the short and long term goals of the program,  the coordination of activities under the program with other participants in the NNI and the current and proposed funding levels for the program and if those funding levels would support the work of the program adequately.

Part 3 would authorize an appropriation of $25 million per fiscal year from 2011 through and including 2015.

S. 2492 has been assigned to the Senate Committee on Heath, Education, Labor and Pensions. No hearings are scheduled at this time. As with legislation introduced in the first session of the 111th Congress, we will monitor and report on the bill's progress.

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