[Congressional Record Volume 156, Number 7 (Thursday, January 21, 2010)]
[Senate]
[Pages S123-S126]
From the Congressional Record Online through the 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
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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 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
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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
that are underway 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
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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).
____________________