II 

112TH CONGRESS 

1ST SESSION S. 1662 

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

nanotechnology regulatory science program. 

IN THE SENATE OF THE UNITED STATES 

OCTOBER 6, 2011 

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 regulatory science 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 Regu5 latory Science Act of 2011’’. 

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. 1013. NANOTECHNOLOGY REGULATORY SCIENCE 

2 PROGRAM. 

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

4 the date of enactment of the Nanotechnology Regulatory 

5 Science Act of 2011, the Secretary, in consultation with 

6 the Secretary of Agriculture, shall establish within the 

7 Food and Drug Administration a program for the sci8 entific investigation of nanomaterials included or intended 

9 for inclusion in products regulated under this Act, to ad10 dress the potential toxicology of such materials, the effects 

11 of such materials on biological systems, and interaction 

12 of such materials with biological systems. 

13 ‘‘(b) PROGRAM PURPOSES.—The purposes of the pro14 gram established under subsection (a) shall be to— 

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

16 general nanomaterials interactions with biological 

17 systems and on specific nanomaterials of concern to 

18 Food and Drug Administration; 

19 ‘‘(2) in cooperation with other Federal agencies, 

20 develop and organize information using databases 

21 and models that will facilitate the identification of 

22 generalized principles and characteristics regarding 

23 the behavior of classes of nanomaterials with biologi24 cal systems; 

25 ‘‘(3) promote intramural Food and Drug Ad26 ministration programs and participate in collaboVerDate Mar 15 2010 21:35 Oct 07, 2011 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1662.IS S1662

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1 rative efforts, to further the understanding of the 

2 science of novel properties at the nanoscale that 

3 might contribute to toxicity; 

4 ‘‘(4) promote and participate in collaborative ef5 forts to further the understanding of measurement 

6 and detection methods for nanomaterials; 

7 ‘‘(5) collect, synthesize, interpret, and dissemi8 nate scientific information and data related to the 

9 interactions of nanomaterials with biological sys10 tems; 

11 ‘‘(6) build scientific expertise on nanomaterials 

12 within such Administration, including field and lab13 oratory expertise, for monitoring the production and 

14 presence of nanomaterials in domestic and imported 

15 products regulated under this Act; 

16 ‘‘(7) ensure ongoing training, as well as dis17 semination of new information within the centers of 

18 such Administration, and more broadly across such 

19 Administration, to ensure timely, informed consider20 ation of the most current science; 

21 ‘‘(8) encourage such Administration to partici22 pate in international and national consensus stand23 ards activities; and 

24 ‘‘(9) carry out other activities that the Sec25 retary determines are necessary and consistent with 


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1 the purposes described in paragraphs (1) through 

2 (8). 

3 ‘‘(c) PROGRAM ADMINISTRATION.— 

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

5 program under this section, the Secretary, acting 

6 through the Commissioner of Food and Drugs, shall 

7 designate a program manager who shall supervise 

8 the planning, management, and coordination of the 

9 program. 

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

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

12 achieving specific short- and long-term technical 

13 goals for the program; 

14 ‘‘(B) coordinate and integrate the strategic 

15 plan with activities by the Food and Drug Ad16 ministration and other departments and agen17 cies participating in the National Nanotechnol18 ogy Initiative; and 

19 ‘‘(C) develop intramural Food and Drug 

20 Administration programs, contracts, memo21 randa of agreement, joint funding agreements, 

22 and other cooperative arrangements necessary 

23 for meeting the long-term challenges and 

24 achieving the specific technical goals of the pro25 gram. 


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1 ‘‘(d) REPORTS.—Not later than March 15, 2014, the 

2 Secretary shall submit to Congress a report on the pro3 gram carried out under this section. Such report shall in4 clude— 

5 ‘‘(1) a review of the specific short- and long6 term goals of the program; 

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

8 funding levels for the program, including an assess9 ment of the adequacy of such funding levels to sup10 port program activities; and 

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

12 under the program with other departments and 

13 agencies participating in the National Nanotechnol14 ogy Initiative. 

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

16 is authorized to be appropriated to carry out this section, 

17 $15,000,000 for fiscal year 2013, $16,000,000 for fiscal 

18 year 2014, and $17,000,000 for fiscal year 2015. 

19 Amounts appropriated pursuant to this subsection shall 

20 remain available until expended.’’. 

Æ 


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