[Congressional Record (Bound Edition), Volume 156 (2010), Part 1]
[Senate]
[Pages 516-518]
[From the U.S. Government Publishing Office, www.gpo.gov]




          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

      By Mr. PRYOR (for himself and Mr. Cardin):
  S. 2942. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
establish a nanotechnology program; to the Committee on Health, 
Education, Labor, and Pensions.
  Mr. PRYOR. Mr. President, I rise today with Senator Cardin to 
introduce the Nanotechnology Safety Act of 2010 which will authorize a 
program of scientific investigation by the Food and Drug Administration 
on nanotechnology-based medical and health products.
  Nanotechnology holds great promise to revolutionize the development 
of new medicines, drug delivery, and orthopedic implants while holding 
down the cost of health care. However, Congress and the FDA must assure 
the public that nanotechnology-based products are both safe and 
efficacious. The Nanotechnology Safety Act of 2010 will 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.
  Nanotechnology, or the manipulation of material at dimensions between 
1 and 100 nanometers, is a challenging scientific area. To put this 
size scale in perspective, a human hair is 80,000 nanometers thick.
  Nanomaterials have different chemical, physical, electrical and 
biological characteristics than when used as larger, bulk materials. 
For example, nanoscale silver has exhibited unique antibacterial 
properties for treating infections and wounds. Nanomaterials have a 
much larger ratio of surface area to mass than ordinary materials do. 
It is at the surface of materials that biological and chemical 
reactions take place, and so we would expect nanomaterials to be more 
reactive than bulk materials.
  The novel characteristics of nanomaterials mean that risk assessments 
developed for ordinary materials may be of limited use in determining 
the health and public safety of products based on nanotechnology.
  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.
  In 2007, the FDA Nanotechnology Task Force published a report 
analyzing the FDA's scientific program and regulatory authority for 
addressing nanotechnology in drugs, medical devices, biologics, and 
food supplements. A general finding of the report is that nanoscale 
materials present regulatory challenges similar to those posed by 
products using other emerging technologies. However, these challenges 
may be magnified because nanotechnology can be used to make almost any 
FDA-regulated product. Also, at the nanoscale, the properties of a 
material relevant to the safety and effectiveness of the FDA-regulated 
products might change.
  The Task Force recommended that the FDA focus on improving its 
scientific knowledge of nanotechnology to help ensure the agency's 
regulatory effectiveness, particularly with regard to products not 
subject to premarket authorization requirements.
  The FDA has already reviewed and approved some nanotechnology-based 
products. In the coming years, they expect a significant increase in 
the use of nanoscale materials in drugs, devices, biologics, cosmetics, 
and food. This will require the FDA to devote more of its regulatory 
attention to nanotechnology based products.
  Let me talk for a few minutes about two areas where nanotechnology is 
already being applied to health care.
  The early detection of cancer and multifunctional therapeutics.
  The early detection of cancer can result in significant improvement 
in human health care and reduction in cost. Nanotechnology offers 
important new tools for detection where existing and more conventional 
technologies may be reaching their limits. The present obstacle to 
early detection of cancer lies in the inability of existing tools to 
detect these molecular level changes directly during early phases in 
the genesis of a cancer. Nanotechnology can provide smart contrast 
agents and tools for real time imaging of a single cell and tissues at 
the nanoscale.
  Nanotechnology promises a host of minimally-invasive diagnostic 
techniques and much research is aimed at ultra-sensitive labeling and 
detection technologies. In the in vitro area, nanotechnology can help 
define cancers by molecular signatures denoting processes that reflect 
fundamental changes in cells and tissues that lead to cancer. Already, 
investigators have developed novel nanoscale in vitro techniques that 
can analyze genomic variations across different tumor types and 
distinguish normal from malignant cells.
  In the in vivo area, one of the most pressing needs in clinical 
oncology is for imaging agents that can identify tumors that are far 
smaller than is possible with today's technology. Achieving this level 
of sensitivity requires better targeting of imaging agents and 
generation of a larger imaging signal, both of which nanoscale devices 
are capable of accomplishing.
  Perhaps the greatest near-term impact of multifunctional therapeutic 
compounds will come in the area of tumor targeting and cancer 
therapies. Nanotechnology can be used to develop new methods of drug 
delivery that better target selected tissues and cells, and to improve 
on the efficiency of drug activity in the cytoplasm or nucleus. Drug 
delivery applications will provide a solution to solubility problems, 
as well as offer intracellular delivery possibilities.
  The introduction of nanotechnology to multifunctional therapeutics is 
at an early stage of development. The delivery of nanoscale 
multifunctional therapeutics could permit very precise site specific 
targeting of cancer cells. More sophisticated ``smart'' systems for 
drug delivery still have to be developed that sense and respond to 
specific chemical agents and are tailored to each patient. 
Multifunctional therapeutic devices need to be developed

[[Page 517]]

that simultaneously detect, diagnose, treat and monitor response to the 
therapy. For example, various nanomaterials can be made to link with a 
drug, a targeting molecule and an imaging agent to seek out cancers and 
release their payload when required.
  The FDA has already begun to devote some resources to the 
understanding of the human health effects and safety of nanotechnology. 
It has established a Nanotechnology Core Facility at the FDA's 
Jefferson Arkansas Laboratories. Combining the expertise of the 
National Center for Toxicological Research and the Arkansas Research 
Laboratory, which is part of the FDA Office of Regulatory Affairs, this 
new Nanotechnology Core Facility will support nanotechnology toxicity 
studies, develop analytical tools to quantify nanomaterials in complex 
matrices, and develop procedures for characterizing nanomaterials in 
FDA-regulated products.
  In conclusion, 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.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 2942

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

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Nanotechnology Safety Act of 
     2010''.

     SEC. 2. NANOTECHNOLOGY PROGRAM.

       Chapter X of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 391 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 1011. NANOTECHNOLOGY PROGRAM.

       ``(a) In General.--Not later than 180 days after the date 
     of enactment of the Nanotechnology Safety Act of 2010, the 
     Secretary of Health and Human Services, in consultation with 
     the Secretary of Agriculture, shall establish within the Food 
     and Drug Administration a program for the scientific 
     investigation of nanoscale materials included or intended for 
     inclusion in FDA-regulated products, to address the potential 
     toxicology of such materials, the effects of such materials 
     on biological systems, and interaction of such materials with 
     biological systems.
       ``(b) Program Purposes.--The purposes of the program 
     established under subsection (a) shall be to--
       ``(1) assess scientific literature and data on general 
     nanoscale material interactions with biological systems and 
     on specific nanoscale materials of concern to Food and Drug 
     Administration;
       ``(2) develop and organize information using databases and 
     models that will enable the formulation of generalized 
     principles for the behavior of classes of nanoscale materials 
     with biological systems;
       ``(3) promote intramural Administration programs and 
     participate in collaborative efforts, to further the 
     understanding of the science of novel properties at the 
     nanoscale that might contribute to toxicity;
       ``(4) promote and participate in collaborative efforts to 
     further the understanding of measurement and detection 
     methods for nanoscale materials;
       ``(5) collect, synthesize, interpret, and disseminate 
     scientific information and data related to the interactions 
     of nanoscale materials with biological systems;
       ``(6) build scientific expertise on nanoscale materials 
     within such Administration;
       ``(7) ensure ongoing training, as well as dissemination of 
     new information within the centers of such Administration, 
     and more broadly across such Administration, to ensure 
     timely, informed consideration of the most current science;
       ``(8) encourage such Administration to participate in 
     international and national consensus standards activities; 
     and
       ``(9) carry out other activities that the Secretary 
     determines are necessary and consistent with the purposes 
     described in paragraphs (1) through (8).
       ``(c) Program Administration.--
       ``(1) Program manager.--In carrying out the program under 
     this section, the Secretary shall designate a program manager 
     who shall supervise the planning, management, and 
     coordination of the program.
       ``(2) Duties.--The program manager shall--
       ``(A) develop a detailed strategic plan for achieving 
     specific short- and long-term technical goals for the 
     program;
       ``(B) coordinate and integrate the strategic plan with 
     investments by the Food and Drug Administration and other 
     departments and agencies participating in the National 
     Nanotechnology Initiative; and
       ``(C) develop intramural Administration programs, 
     contracts, memoranda of agreement, joint funding agreements, 
     and other cooperative arrangements necessary for meeting the 
     long-term challenges and achieving the specific technical 
     goals of the program.
       ``(d) Reports.--Not later than March 1, 2012 and March 1, 
     2014, the Secretary shall submit to the Committee on Health, 
     Education, Labor, and Pensions and the Committee on 
     Appropriations of the Senate and the Committee on Energy and 
     Commerce and the Committee on Appropriations of the House of 
     Representatives a report on the program carried out under 
     this section. Such report shall include--
       ``(1) a review of the specific short- and long-term goals 
     of the program;
       ``(2) an assessment of current and proposed funding levels 
     for the program, including an assessment of the adequacy of 
     such funding levels to support program activities; and
       ``(3) a review of the coordination of activities under the 
     program with other departments and agencies participating in 
     the National Nanotechnology Initiative.
       ``(e) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section, 
     $25,000,000 for each of fiscal years 2011 through 2015. 
     Amounts appropriated pursuant to this subsection shall remain 
     available until expended.''.
                                 ______
                                 

 By Ms. COLLINS (for herself, Mr. Lieberman, Mr. Bennett, Mr. Ensign, 
                             and Mr. Bond):

  S. 2943. A bill to require the Attorney General to consult with 
appropriate officials within the executive branch prior to making the 
decision to try an unprivileged enemy belligerent in Federal civilian 
court; to the Committee on the Judiciary.
  Ms. COLLINS. Mr. President, yesterday the Senate Homeland Security 
Committee heard testimony from the three top U.S. intelligence 
officials about the errors that the Federal Government made leading up 
to the thwarted Christmas Day plot. We dodged a bullet that day when 
Umar Farouk Abdulmutallab, a Nigerian-born terrorist, failed to 
detonate a bomb on flight 253 in the skies above Detroit.
  But today, Mr. President, I rise to discuss an error that was made 
after that foreign terrorist had already been detained by American 
authorities in Detroit, an error that may well have prevented the 
collection of valuable intelligence about future terrorist threats to 
our country. The error became clear during my questioning of three of 
our Nation's top intelligence officials at the committee's hearing 
yesterday. Frankly, Mr. President, I was stunned to learn that the 
decision to place the captured terrorist into the U.S. civilian 
criminal court system had been made without any input or the knowledge 
of the Director of National Intelligence, the Director of the National 
Counterterrorism Center, or the Secretary of the Department of Homeland 
Security. That is right, Mr. President, these officials were never 
consulted by the Department of Justice before the decision was made.
  That decision was critical. The determination to charge Abdulmutallab 
in civilian court likely foreclosed the collection of additional 
intelligence information. We know that the interrogation of terrorists 
can provide critical intelligence, but our civil justice system, as 
opposed to the military detention and tribunal system established by 
Congress and the President, encourages terrorists to lawyer up and to 
stop answering questions. Indeed, that was exactly what happened in the 
case of Abdulmutallab. He had provided some valuable information to law 
enforcement officials in the hours immediately after his capture, and 
we surely would have obtained more information if we had treated this 
foreign terrorist as an enemy belligerent and had placed him in the 
military tribunal system. Instead, once he was read his Miranda rights, 
given a lawyer at our expense, he was advised to cease answering 
questions, and that is exactly what he did.
  That poor decisionmaking may well have prevented us from finding out 
more of Yemen's role in training terrorists and more about future plots

[[Page 518]]

that are under way in Yemen targeting American citizens in this country 
or abroad. Good intelligence is clearly critical to our ability to stop 
terrorist plots before they are executed. We know that lawful 
interrogations of terrorist suspects can provide important 
intelligence. To charge Abdulmutallab in the civilian criminal system 
without even consulting three of our Nation's top intelligence 
officials simply defies common sense.
  To correct this failure and to ensure that our Nation's senior 
intelligence officials are consulted before making the decision to try 
future foreign terrorists in civilian court, I am today introducing a 
bill that would require this crucial consultation. I am very pleased to 
be joined by the chairman of the Homeland Security Committee, Senator 
Lieberman, who has been such a leader in this entire area, as well as 
by three other Senators, Senator Bob Bennett, Senator John Ensign and 
Senator Kit Bond, who are also concerned about the testimony yesterday.
  Specifically, our bill would require the Attorney General to consult 
with the Director of National Intelligence, the Director of the 
National Counterterrorism Center, the Secretary of Homeland Security, 
and the Secretary of Defense before initiating a custodial 
interrogation of foreign terrorists or filing civilian criminal charges 
against them. These officials, Mr. President, are in the best position 
to know what other threats the United States is facing from terrorists 
and to assess the need to gather more intelligence on those threats.
  If there is a disagreement between the Attorney General and these 
intelligence officials regarding the appropriate approach to the 
detention and interrogation of foreign terrorists, then the bill would 
require the President to resolve the disagreement. Only the President 
would be permitted to direct the initiation of civilian law enforcement 
actions--balancing his constitutional responsibilities as Commander in 
Chief and as the Nation's chief law enforcement officer.
  To be clear, this legislation would not deprive the President of any 
investigative or prosecutorial tool. It would not preclude a decision 
to charge a foreign terrorist in our military tribunal system or in our 
civilian criminal justice system. It would simply require that the 
Attorney General coordinate and consult with our top intelligence 
officials before making a decision that could foreclose the collection 
of critical additional intelligence information.
  This consultation requirement is not unprecedented. Section 811 of 
the Counterintelligence and Security and Enhancements Act of 1994 
requires the Director of the FBI and the head of a department or agency 
with a potential spy in its ranks to consult and periodically reassess 
any decision to leave the suspected spy in place so that additional 
intelligence can be gathered on his activities.
  As the Senate Intelligence Committee noted in its report on the 
legislation that added the espionage consultation requirement:

       While prosecutorial discretion ultimately rests with the 
     Department of Justice officials, it stands to reason that in 
     cases designed to protect our national security--such as 
     espionage and terrorism cases--prosecutors should ensure that 
     they do not make decisions that, in fact, end up harming the 
     national security.

  The committee got it right. The committee went on to explain:

       [T]he determination of whether to leave a subject in place 
     should be retained by the host agency.

  The history of the espionage consultation requirement is eerily 
reminiscent of the lack of consultation that occurred in the case of 
Abdulmutallab. In espionage cases, Congress has already recognized that 
when valuable intelligence is at stake, our national security should 
trump decisions based solely on prosecutorial equities. This 
requirement must be extended to the most significant threat facing our 
Nation, and that is the threat of terrorism.
  I encourage the Senate to act quickly on this important legislation. 
The changes proposed are modest. They make common sense. But the 
consequences could be a matter of life and death.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 2943

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

     SECTION 1. CONSULTATION REQUIREMENT.

       (a) In General.--Subject to subsection (b), no action shall 
     be taken by the Attorney General, or any officer or employee 
     of the Department of Justice, to--
       (1) initiate a custodial interrogation of; or
       (2) file a civilian criminal complaint, information, or 
     indictment against;

     any foreign person detained by the United States Government 
     because they may have engaged in conduct constituting an act 
     of war against the United States, terrorism, or material 
     support to terrorists, or activities in preparation therefor.
       (b) Consultation.--
       (1) In general.--Subject to paragraph (2), the Attorney 
     General shall consult with the Director of National 
     Intelligence, the Director of the National Counterterrorism 
     Center, the Secretary of Homeland Security, and the Secretary 
     of Defense prior to taking any action identified in 
     subsection (a).
       (2) Presidential direction.--If, following consultation 
     under paragraph (1), the Director of National Intelligence, 
     the Director of the National Counterterrorism Center, the 
     Secretary of Homeland Security, or the Secretary of Defense 
     believe that any action identified in subsection (a) and 
     proposed by the Attorney General may prevent the collection 
     of intelligence related to terrorism or threats of violence 
     against the United States or its citizens, the Attorney 
     General may not initiate such action without specific 
     direction from the President.
       (c) Annual Report.--The Attorney General shall report 
     annually to appropriate committees of jurisdiction regarding 
     the number of occasions on which direction was sought from 
     the President under subsection (b)(2) and the number of 
     times, on those occasions, that the President directed 
     actions identified in section (a) against such foreign 
     person.
       (d) Definitions.--In this section:
       (1) Appropriate committees of jurisdiction.--The term 
     ``appropriate committees of jurisdiction'' shall include--
       (A) the Committee on Homeland Security and Governmental 
     Affairs of the Senate;
       (B) the Committee on Homeland Security of the House of 
     Representatives;
       (C) the Select Committee on Intelligence of the Senate;
       (D) the Permanent Select Committee on Intelligence of the 
     House of Representatives; and
       (E) the Committees on Armed Services and Judiciary of the 
     Senate and the Committees on Armed Services and Judiciary of 
     the House of Representatives.
       (2) Act of war, terrorism, material support to 
     terrorists.--The terms ``act of war'', ``terrorism'', and 
     ``material support to terrorists'' shall have the meanings 
     given such terms in title 18, United States Code.
       (e) Savings Clause.--Nothing in this section shall prevent 
     the Attorney General, or any officer or employee of the 
     Department of Justice, from apprehending or detaining an 
     individual as authorized by the Constitution or laws of the 
     United States except to the extent that activities incident 
     to such apprehension or detention are specifically identified 
     in subsection (a).

                          ____________________