II 

111TH CONGRESS 

2D SESSION S. 2942 

To amend the Federal Food, Drug, and Cosmetic Act to establish a 

nanotechnology program. 

IN THE SENATE OF THE UNITED STATES 

JANUARY 21, 2010 

Mr. PRYOR (for himself and Mr. CARDIN) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

establish a nanotechnology program. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Nanotechnology Safety 

5 Act of 2010’’. 

6 SEC. 2. NANOTECHNOLOGY PROGRAM. 

7 Chapter X of the Federal Food, Drug, and Cosmetic 

8 Act (21 U.S.C. 391 et seq.) is amended by adding at the 

9 end the following: 


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1 ‘‘SEC. 1011. NANOTECHNOLOGY PROGRAM. 

2 ‘‘(a) IN GENERAL.—Not later than 180 days after 

3 the date of enactment of the Nanotechnology Safety Act 

4 of 2010, the Secretary of Health and Human Services, 

5 in consultation with the Secretary of Agriculture, shall es6 tablish within the Food and Drug Administration a pro7 gram for the scientific investigation of nanoscale materials 

8 included or intended for inclusion in FDA-regulated prod9 ucts, to address the potential toxicology of such materials, 

10 the effects of such materials on biological systems, and 

11 interaction of such materials with biological systems. 

12 ‘‘(b) PROGRAM PURPOSES.—The purposes of the pro13 gram established under subsection (a) shall be to— 

14 ‘‘(1) assess scientific literature and data on 

15 general nanoscale material interactions with biologi16 cal systems and on specific nanoscale materials of 

17 concern to Food and Drug Administration; 

18 ‘‘(2) develop and organize information using 

19 databases and models that will enable the formula20 tion of generalized principles for the behavior of 

21 classes of nanoscale materials with biological sys22 tems; 

23 ‘‘(3) promote intramural Administration pro24 grams and participate in collaborative efforts, to fur25 ther the understanding of the science of novel propVerDate Nov 24 2008 04:02 Jan 22, 2010 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2942.IS S2942

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1 erties at the nanoscale that might contribute to tox2 icity; 

3 ‘‘(4) promote and participate in collaborative ef4 forts to further the understanding of measurement 

5 and detection methods for nanoscale materials; 

6 ‘‘(5) collect, synthesize, interpret, and dissemi7 nate scientific information and data related to the 

8 interactions of nanoscale materials with biological 

9 systems; 

10 ‘‘(6) build scientific expertise on nanoscale ma11 terials within such Administration; 

12 ‘‘(7) ensure ongoing training, as well as dis13 semination of new information within the centers of 

14 such Administration, and more broadly across such 

15 Administration, to ensure timely, informed consider16 ation of the most current science; 

17 ‘‘(8) encourage such Administration to partici18 pate in international and national consensus stand19 ards activities; and 

20 ‘‘(9) carry out other activities that the Sec21 retary determines are necessary and consistent with 

22 the purposes described in paragraphs (1) through 

23 (8). 

24 ‘‘(c) PROGRAM ADMINISTRATION.— 


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1 ‘‘(1) PROGRAM MANAGER.—In carrying out the 

2 program under this section, the Secretary shall des3 ignate a program manager who shall supervise the 

4 planning, management, and coordination of the pro5 gram. 

6 ‘‘(2) DUTIES.—The program manager shall— 

7 ‘‘(A) develop a detailed strategic plan for 

8 achieving specific short- and long-term technical 

9 goals for the program; 

10 ‘‘(B) coordinate and integrate the strategic 

11 plan with investments by the Food and Drug 

12 Administration and other departments and 

13 agencies participating in the National Nano14 technology Initiative; and 

15 ‘‘(C) develop intramural Administration 

16 programs, contracts, memoranda of agreement, 

17 joint funding agreements, and other cooperative 

18 arrangements necessary for meeting the long19 term challenges and achieving the specific tech20 nical goals of the program. 

21 ‘‘(d) REPORTS.—Not later than March 1, 2012, and 

22 March 1, 2014, the Secretary shall submit to the Com23 mittee on Health, Education, Labor, and Pensions and the 

24 Committee on Appropriations of the Senate and the Com25 mittee on Energy and Commerce and the Committee on 


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1 Appropriations of the House of Representatives a report 

2 on the program carried out under this section. Such report 

3 shall include— 

4 ‘‘(1) a review of the specific short- and long5 term goals of the program; 

6 ‘‘(2) an assessment of current and proposed 

7 funding levels for the program, including an assess8 ment of the adequacy of such funding levels to sup9 port program activities; and 

10 ‘‘(3) a review of the coordination of activities 

11 under the program with other departments and 

12 agencies participating in the National Nanotechnol13 ogy Initiative. 

14 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

15 are authorized to be appropriated to carry out this section, 

16 $25,000,000 for each of fiscal years 2011 through 2015. 

17 Amounts appropriated pursuant to this subsection shall 

18 remain available until expended.’’. 

Æ 


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