S. Hrg. 111-353
STRENGTHENING SECURITY AND OVERSIGHT AT BIOLOGICAL RESEARCH
LABORATORIES
=======================================================================
HEARING
before the
SUBCOMMITTEE ON TERRORISM
AND HOMELAND SECURITY
of the
COMMITTEE ON THE JUDICIARY
UNITED STATES SENATE
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
__________
SEPTEMBER 22, 2009
__________
Serial No. J-111-48
__________
Printed for the use of the Committee on the Judiciary
U.S. GOVERNMENT PRINTING OFFICE
55-644 WASHINGTON : 2009
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing
Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; DC
area (202) 512-1800 Fax: (202) 512-2104 Mail: Stop IDCC, Washington, DC
20402-0001
COMMITTEE ON THE JUDICIARY
PATRICK J. LEAHY, Vermont, Chairman
HERB KOHL, Wisconsin JEFF SESSIONS, Alabama
DIANNE FEINSTEIN, California ORRIN G. HATCH, Utah
RUSSELL D. FEINGOLD, Wisconsin CHARLES E. GRASSLEY, Iowa
CHARLES E. SCHUMER, New York JON KYL, Arizona
RICHARD J. DURBIN, Illinois LINDSEY GRAHAM, South Carolina
BENJAMIN L. CARDIN, Maryland JOHN CORNYN, Texas
SHELDON WHITEHOUSE, Rhode Island TOM COBURN, Oklahoma
AMY KLOBUCHAR, Minnesota
EDWARD E. KAUFMAN, Delaware
ARLEN SPECTER, Pennsylvania
AL FRANKEN, Minnesota
Bruce A. Cohen, Chief Counsel and Staff Director
Matt Miner, Republican Chief Counsel
------
Subcommittee on Terrorism and Homeland Security
BENJAMIN L. CARDIN, Maryland, Chairman
HERB KOHL, Wisconsin JON KYL, Arizona
DIANNE FEINSTEIN, California ORRIN G. HATCH, Utah
CHARLES E. SCHUMER, New York JEFF SESSIONS, Alabama
RICHARD J. DURBIN, Illinois JOHN CORNYN, Texas
AL FRANKEN, Minnesota TOM COBURN, Oklahoma
EDWARD E. KAUFMAN, Delaware
Bill Van Horne, Democratic Chief Counsel
Stephen Higgins, Republican Chief Counsel
C O N T E N T S
----------
STATEMENTS OF COMMITTEE MEMBERS
Page
Cardin, Hon. Benjamin L., a U.S. Senator from the State of
Maryland....................................................... 1
prepared statement........................................... 33
WITNESSES
Graham, Hon. Robert, former U.S. Senator from the State of
Florida, Chair, Commission for the Prevention of Weapons of
Mass Destruction Proliferation and Terrorism, Washington, D.C.,
statement...................................................... 17
Greenberger, Michael, Founder and Director, University of
Maryland Center for Health and Homeland Security, and Law
School Professor, University of Maryland School of Law,
Baltimore, Maryland, statement................................. 23
Kingsbury, Nancy, Ph.D., Managing Director, Applied Research and
Methods, Government Accountability Office, Washington, D.C.,
statement...................................................... 20
Pasco, Brandt, Compliance Assurance Program Manager, Department
of Homeland Security, Washington, D.C.......................... 8
Reed, Jean, Deputy Assistant to the Secretary of Defense,
Chemical and Biological Defense, Chemical Demilitarization,
Department of Defense, Arlington, Virginia..................... 5
Roberts, Daniel D., Criminal Justice Information Services,
Federal Bureau of Investigation, Department of Justice,
Washington, D.C................................................ 3
SUBMISSIONS FOR THE RECORD
Center for Disease Control and Prevention, Select Agent Program,
Washington, D.C., statement.................................... 35
Graham, Hon. Robert, former U.S. Senator from the State of
Florida, Chair, Commission for the Prevention Weapons of Mass
Destruction Proliferation and Terrorism, Washington, D.C.,
statement...................................................... 38
Greenberger, Michael, Founder and Director, University of
Maryland Center for Health and Homeland Security, and Law
School Professor, University of Maryland School of Law,
Baltimore, Maryland, statement................................. 43
Kingsbury, Nancy, Ph.D., Managing Director, Applied Research and
Methods, Government Accountability Office, Washington, D.C.,
statement...................................................... 73
Pasco, Brandt, Compliance Assurance Program Manager, Department
of Homeland Security, Washington, D.C.......................... 81
Reed, Jean D., Deputy Assistant to the Secretary of Defense,
Chemical and Biological Defense/Chemical Demilitarization,
Department of Defense, Arlington, Virginia, statement.......... 86
Roberts, Daniel D., Assistant Director, Criminal Justice
Information Services Division, Federal Bureau of Investigation,
Department of Justice, Washington, D.C., statement............. 93
STRENGTHENING SECURITY AND OVERSIGHT AT BIOLOGICAL RESEARCH
LABORATORIES
----------
TUESDAY, SEPTEMBER 22, 2009
U.S. Senate,
Subcommittee on Terrorism and Homeland Security,
Committee on the Judiciary,
Washington, DC
The Subcommittee met, pursuant to notice, at 2:42 p.m.,
Room 226, Dirksen Senate Office Building, Hon. Benjamin Cardin,
Chairman of the Subcommittee, presiding.
OPENING STATEMENT OF HON. BENJAMIN L. CARDIN, A U.S. SENATOR
FROM THE STATE OF MARYLAND, CHAIRMAN, SUBCOMMITTEE ON TERRORISM
AND HOMELAND SECURITY
Senator Cardin. Well, the Subcommittee will come to order.
Let me apologize for being a few minutes late. The Senate was
taking its traditional every, I think, 2-year photograph, so
that's one of the busy moments on the floor of the U.S. Senate.
So, I apologize for the late start.
I also want to express Senator Kyl's regrets. He's going to
try to come by. He is involved in the Senate Finance Committee
right now on health care reform, and obviously is very busy on
that issue. So he's going to try to come by, but he wanted me
to express his strong support for this hearing, the oversight
role that the Judiciary Committee needs to play on the labs
that we have, the biological research laboratories in this
country, and he is very much interested in the recommendations
that are coming out from the various workgroups and commissions
that are looking into this matter.
After the 9/11 terrorist attacks, Americans suffered
another type of terrorist attack in October of 2001: the
biological attacks. Letters were mailed to Members of Congress
using the U.S. Postal Service, ultimately resulting in the
death and sickening of dozens of individuals. The Federal
Government responded by increasing funds for bio-defense.
Congress also implemented the 9/11 Commission recommendations,
which called for the creation of the Department of Homeland
Security and urged the government to take stronger measures to
deny weapons of mass destruction to terrorists.
High-containment laboratories played a critical role in the
bio-defense effort and evolved collaborative efforts between
the public and private sectors, military and civilian
communities, as well as our international partners. At the same
time, increasing the number of personnel in laboratories with
access to these deadly agents may increase the chances of
accidental or deliberate misuse of hazardous materials, posing
a significant public health threat.
Today's hearing will examine the current security measures
at our laboratories, including both physical security and
personnel reliability, and look at the best practices in both
the government and private sector, including our Nation's
preeminent research laboratories.
We will also examine the various government agencies that
have oversight responsibilities for these programs, as well as
recommendations from organizations as to how to strengthen and
improve our security at these laboratories, while not unduly
chilling innovation, research, and collaborative efforts with
our international allies.
The FBI recently concluded that the October 2001 anthrax
attacks were carried out by a government scientist working in a
biological research lab at Ft. Detrick, in my own State of
Maryland. I have visited this military base on numerous
occasions. Just last month, the Army broke ground on a new $680
million headquarters building for the U.S. Army Medical
Research Institute for Infectious Diseases at Ft. Detrick,
Maryland, which will house the most cutting-edge research on
dangerous biological organisms in the highest possible bio-
safety space known as a Bio-Safety Level IV, BSL-IV. This
precaution is being used in order to protect the workers at Ft.
Detrick and the surrounding communities in Frederick, Maryland.
The laboratories will conduct research on the most deadly
pathogens known to mankind, including anthrax, the plague, and
the Ebola virus. I know that our Ft. Detrick employees have
also been working to help the government to combat swine flu
and the West Nile virus, among others.
Panel one this afternoon will examine the executive
branch's current efforts to strengthen and improve bio-security
and bio-safety at laboratories, including personnel
reliability, physical and perimeter security, and inventory
control. I look forward to hearing from the witnesses from the
Departments of Justice, Defense, and Homeland Security.
In panel two, we will receive testimony from outside
experts, including the recent report on the Commission on the
Prevention of Weapons of Mass Destruction, chaired by the
distinguished former Senator from Florida, Senator Graham, who
has also served as Chairman of the Senate Intelligence
Committee. We will also receive testimony from the Government
Accountability Office and the Center for Health and Homeland
Security at the University of Maryland at Baltimore.
With that, we will go directly to our first panel, who will
consist of Daniel Roberts, who is the Assistant Director of the
FBI's largest division, the Criminal Justice Information
Services Division, established in 1992 to serve as the focal
point and central repository for Criminal Justice Information
Services in the FBI.
Jean Reed is the Deputy Assistant to the Secretary of
Defense for Chemical and Biological Defense and Chemical
Demilitarization in the Office of the Assistant to the
Secretary of Defense for Nuclear, Chemical, and Biological
Programs.
Brandt Pasco was appointed to be the Deputy Secretary to be
the DHS Compliance Assurance Program Manager. He is an attorney
in the Department of Homeland Security, Office of General
Counsel, who supports the Science and Technology Directorate,
managing an office with 14 staff.
With that, if I could ask the three of you to please stand
in order to take the traditional oath of our Committee, and
then we'll get started with your testimony.
[Whereupon, the witnesses were duly sworn.]
Senator Cardin. Thank you all very much. Please have a
seat.
Mr. Roberts, we are glad to hear from you.
STATEMENT OF DANIEL D. ROBERTS, CRIMINAL JUSTICE INFORMATION
SERVICES, FEDERAL BUREAU OF INVESTIGATION, U.S. DEPARTMENT OF
JUSTICE, WASHINGTON, DC
Mr. Roberts. Good afternoon, Chairman Cardin, Ranking
Member Kyl, and the distinguished members of the Subcommittee
on Terrorism and Homeland Security. I am Daniel D. Roberts,
Assistant Director of the FBI's Criminal Justice Information
Services Division, or CJIS, located in Clarksburg, West
Virginia. I have served in the FBI for over 22 years, but have
only held my current position since June of 2009. I thank you
for the opportunity to appear before this Subcommittee.
The CJIS Division maintains oversight of two major
background assessment programs: the more commonly known,
National Instant Criminal Background Check System, assesses a
person's eligibility to possess a firearm or explosive; the
lesser known program, the Bio-Terrorism Risk Assessment Group,
or BRAG, is similar in mission. BRAG's role is to enhance
national security and public safety by providing the timely and
accurate determination of an individual's eligibility to use,
possess, or transfer select agents and toxins.
Candidates are evaluated for access to select agents and
toxins against criteria delineated within the Public Health,
Security, and Bio-Terrorism Preparedness and Response Act of
2002, and against prohibitive categories defining a restricted
person within the USA Patriot Act. Pursuant to the Bio-
Terrorism Act, the Attorney General of the United States is
charged with using criminal, immigration, national security,
and other electronic data bases to determine whether an entity
or an individual is a restricted person.
The Attorney General delegated this authority to the
Director of the Federal Bureau of Investigation in January of
2003. The BRAG began conducting Security Risk Assessments, or
SRAs, in collaboration with officials from the Department of
Health and Human Services and the Department of Agriculture in
April of 2003.
SRAs are conducted on entities, except Federal, State, and
local government agencies, including public accredited academic
institutions, any individual who owns or controls the entity,
responsible officials, and alternate responsible officials
managing entity operations every 3 years.
SRAs are conducted not less frequently than once every 5
years on individuals requiring access to select agents and
toxins. A typical SRA takes about 1 month to complete. The SRA
is different than a full background investigation, such as
those conducted for security clearances, and complies with the
requirements of the Bio-Terrorism Act.
The SRA commences when BRAG receives a candidate's Form FD-
961 and two legible fingerprint cards. The fingerprint cards
are processed by the FBI's integrated automated fingerprint
identification system and flagged to identify the record as
belonging to an individual who underwent an SRA. The FD-961
data, supplied by the candidate in response to questions
directly concerning each prohibitor, is then entered into
BRAG's stand-alone bio-terrorism data base maintained by CJIS.
The candidate's case is subsequently assigned to a BRAG
personnel security specialist for research. Upon completion of
all data base searches, the candidate's status is determined
and the results are submitted to the sponsoring agency. The
sponsor provides, in writing, the decision indicating denial or
approval of access to the candidate.
If the access is denied, the candidate is advised of the
specific prohibiting factor applied to them. Candidates may
appeal the decision via their sponsor within 30 days of
notification of denial. The sponsor will forward a statement of
factual basis for the appeal and supporting documentation
provided by the candidate to the FBI for reconsideration.
The FBI will review the candidate's documentation and
research the appropriate data bases. The FBI will either
overturn the results of the original SRA or sustain the
original determination of status. The sponsor is again advised
of the results and, in turn, notifies the candidate in writing
of the decision.
Since the inception of the program, the BRAG has completed
32,742 SRAs; 208 individuals have been restricted. The CJIS
Division, in close coordination with the Centers for Disease
Control and Prevention and the Animal and Plant Health
Inspection Service, is continually scrutinizing and evaluating
the SRA process. Efforts are ongoing to automate the workflow
and improve information sharing capabilities.
Mr. Chairman, I would like to conclude by thanking you,
Ranking Member Kyl, and this Subcommittee for your service and
support. I look forward to working with you in the years to
come as we continue to counter bio-security threats of the
future. I would also like to personally thank the Department of
Health and Human Services, Centers for Disease Control and
Prevention, and the Department of Agriculture's Animal and
Plant Health Inspection Service for years of unwavering
support.
Thank you for the opportunity to appear before your
Subcommittee, and I look forward to answering any questions you
may have.
[The prepared statement of Mr. Roberts appears as a
submission for the record.]
Senator Cardin. Thank you very much for your testimony.
Mr. Reed.
STATEMENT OF JEAN REED, DEPUTY ASSISTANT TO THE SECRETARY OF
DEFENSE, CHEMICAL AND BIOLOGICAL DEFENSE/CHEMICAL
DEMILITARIZATION, U.S. DEPARTMENT OF DEFENSE, ARLINGTON, VA
Mr. Reed. Chairman Cardin, I would request that my printed
statement be entered in the record.
Senator Cardin. Without objection, the full statements of
all of the witnesses will be included in the record today.
[The prepared statement of Mr. Reed appears as a submission
for the record.]
Mr. Reed. Mr. Chairman, it's a pleasure to testify before
the Committee today. I'm accompanied by Major General James
Gilman, Commanding General, U.S. Army Medical Research and
Materiel Command in Ft. Detrick; and Colonel John Skvorak,
Commander of the U.S. Army Medical Research Institute for
Infectious Diseases, whom I believe you know; and also by
Captain Kenneth Cole, who's the Medical Director for the
Chemical/Biological Defense program, and they're here to bail
me out if I get in trouble, so I would beg leave to perhaps
have them provide some of the detailed answers to the
questions.
Senator Cardin. You've got a good support team.
Mr. Reed. Great. They are good people.
It's a pleasure, again, to be able to have the opportunity
to discuss with you the safety and security of our Nation's
biological research laboratories. They are a keystone to our
Nation's life science research and are essential to developing
public health infrastructure and medical countermeasures
crucial to protecting U.S. citizens from biological threats,
whether as a result of natural or intentional actions.
Today I will briefly discuss Department of Defense
regulations, practices, and procedures put in place since the
2001 anthrax incidents that can be applied to improve
laboratory bio-security. It is imperative that the
implementation of best practices on a national scale optimize
the security of biological agents, while providing minimal
impact on that life science research necessary to develop
public health and medical countermeasures against these agents.
I will provide an overview of how DOD regulations came into
existence, how they have been implemented, their proposed
integration into current national efforts, and a possible way
forward to develop best practices and procedures for Bio-Safety
Level, BSL-IV, laboratory safety and security.
Our BSL-III and BSL-IV laboratories operate as a critical
element of our bio-defense efforts to understand pathogens of
concern and to develop medical countermeasures to defeat these
pathogens, whether they are biological warfare agents, or are
infectious diseases to which our armed forces may be exposed.
Following the 2001 anthrax incidents, Congress passed a
series of legislative initiatives to control human, plant, and
animal pathogens of concern. This legislation led to the
expansion of Select Agent Regulations, which require each
Federal agency to conduct safety and risk assessments, but did
not preclude agencies from implementing efforts above and
beyond those required by the regulations for safeguarding
biological select agents and toxins.
The term ``select agent'' refers to a specific group of
chemical or biological agents that historically have been
evaluated and developed for use in weapons. Although the United
States does not have a biological weapons program, the use of
this term and its historical connotation as being associated
with weapons programs heavily influenced the direction the
Department would take to safeguard biological agents in its
laboratories.
Accordingly, the Department drew, from its current chemical
and nuclear programs, safeguarding measures in developing the
regulations for so-called biological select agents and toxins,
which the Department uses only for basic and applied research
in the development of vaccines, therapeutics, and protective
countermeasures.
The current DOD risk management framework for safeguarding
select agents and toxins consists of a fourfold approach: bio-
safety, bio-security, personal reliability, and agent
accountability.
Bio-safety consists of the application of knowledge,
techniques, and equipment to prevent personal, laboratory, and
environmental exposure to potentially infectious agents or bio-
hazards. Bio-security refers to the protection, control, and
accountability of high consequence biological agents and
toxins, critical relevant biological materials and information
within laboratories to prevent unauthorized possession, loss,
theft, misuse, diversion, or intentional release. The
biological personal reliability program consists of security
background investigations, as well as medical, mental health,
and drug screening.
Agent accountability consists of the registration of
agents, personnel, entities, and locations, agent inventory
control, and limiting access to registered personnel.
All of the above measures implemented by the Department of
Defense exceed the prescribed requirements of the Select Agent
Rules. This does not mean that the additional measures
constitute a series of best practices and procedures, but only
represents the extrapolation of the DOD current weapon materiel
safeguarding policies as applied against biological agents. In
fact, they highlight the challenges that arise from the direct
application of DOD current policies for safeguarding weapons
materiel to the unique situation of defense research on
biological organisms.
Biological agents differ from nuclear and chemical threats
by their nature and by virtue of their context. Nuclear and
chemical agents are entirely man-made; biological agents are
found throughout nature and exist in the context of infectious
disease and public health threats, notwithstanding that they
can be potentially used for hostile purposes.
This is not to say that there are elements of these
regulations that could not be incorporated into best practices.
However, a series of studies, both within the DOD and
externally, suggest that some elements of this program may be
too extreme and could not be implemented by other agencies or
the civilian sector without severe impact.
For example, the use of Single-Scope Background
Investigations precludes foreign nationals or personnel having
limiting factors, such as financial difficulties or prior non-
criminal legal actions, from working with select agents. Such
background investigations are time-intensive and expensive.
Additionally, they would preclude a large segment of
exceptionally qualified and talented researchers, particularly
foreign national researchers who currently make daily
contributions to the advancement of medical or other life
science research, from participating in this activity that is
so important to the Nation.
Several recent studies highlight the lack of data to
demonstrate that such detailed background investigations
provide substantial value over the current Department of
Justice Security Risk Assessment. There have been a number of
internal DOD studies and external studies over the past 2 years
that have explored the efficacy and efficiency of current and
proposed regulations and policies to strengthen laboratory bio-
security.
Reports from the National Science Advisory Board for Bio-
Security and the Defense Science Board were submitted to the
executive branch with a series of recommendations and policy
options that can be applied to establishing best practices and
procedures for the Nation. Reports of Executive Order 13486
Working Group on Strengthening the Laboratory Bio-Security of
the United States and the National Academy of Sciences are in
their final stage of staffing and will be submitted to the
executive branch in the very near future. Additionally, the
Trans-Federal Task Force on Optimizing Bio-Safety and Bio-
Containment Oversight is soon submitting its report to the
executive branch.
A potential way forward would be to allow the National
Security Council to use its interagency policy committee
process in conjunction with input from industry and academia,
to review the recommendations and policy options from the
collective reports, and develop an approach for the Nation that
optimizes the balance between science and security. Once such
an approach is identified, legislative action could be well-
targeted to ensure the full range of helpful measures needed to
enable its implementation.
In summary, the current DOD safety and security measures
for safeguarding biologicals, select agents, and toxins are
derived from its protocols that were originally developed to
safeguard nuclear and chemical weapons materiels, and not the
biological organisms that are critical to developing defenses
against our adversaries' biological weapons and naturally-
occurring infectious diseases.
Although these practices derive from a robust history of
security, they might not constitute the basis for best
practices and procedures for the Nation, as they could
discourage participation by critical organizations and could be
limiting to medical and other life sciences research programs.
A more prudent approach would be to exploit the information
gathered by the various studies conducted over the past 2
years, develop a series of appropriately tailored policies and
practices that balance between safety and security and the
pursuit of a robust biological research and development program
necessary to ensure the ability to respond to naturally-
occurring pathogens, defense of the U.S. homeland, and
protection of our service members.
Senator, thank you for this opportunity to address you on
this matter of national importance, as well as your continued
support to the Department of Defense. I would be happy to
answer any questions the Subcommittee may have.
Senator Cardin. Thank you very much, Mr. Reed.
Mr. Pasco.
STATEMENT OF BRANDT PASCO, COMPLIANCE ASSURANCE PROGRAM
MANAGER, U.S. DEPARTMENT OF HOMELAND SECURITY, WASHINGTON, DC
Mr. Pasco. Chairman Cardin, Ranking Member Kyl, and
distinguished Senators, thank you for the opportunity to talk
about the good work being done today at DHS related to bio-
security. It's a pleasure to be back in the U.S. Senate, where
I started my professional life. I have submitted testimony for
the record, so I will be brief to ensure there's time for
questions.
By way of introduction, allow me to explain, briefly, my
role at DHS. I was appointed by the Deputy Secretary to be the
Department's Compliance Assurance Program Manager. I'm an
attorney in the Office of the General Counsel, who supports the
Science and Technology Directorate. I manage an office with 14
staff and an fiscal year `09 budget of approximately $2.8
million, and I oversee compliance efforts at the Science and
Technology Directorate, including for biological safety and
security.
DHS's compliance program provides an objective and
independent review of all ongoing DHS life science programs. It
is a complete programmatic life cycle review. Treaty compliance
is ensured both at the program's inception and when significant
changes are proposed. Regulatory compliance is checked
throughout the life of project execution, and information
generated by the program is continually reviewed for national
security concerns.
The cornerstone of the process is the Department's
Compliance Review Group, which oversees arms control treaty
compliance. The Compliance Review Group is comprised of DHS
senior leadership and chaired by the Deputy Secretary. All
biological research conducted by the Department must be
determined by the Compliance Review Group to be compliant with
U.S. law and our international obligations.
In generating compliance assessments for the Compliance
Review Group, projects fall within one of three categories.
Category 1 projects, as presented, do not raise compliance
concerns. Three hundred and sixty-eight Category 1 projects
have been approved by the Compliance Review Group to date.
Category 2 projects, as presented, might reasonably raise
the perception of a compliance issue but do not involve the
National Science Advisory Board for Bio-Security Research
concern. Eighteen Category 2 projects have been approved by the
Compliance Review Group to date.
Category 3 projects, as presented, might reasonably raise a
perception of compliance and likely do involve research of
concern. Twenty-two Category 3 projects have been approved by
the Compliance Review Group to date.
DHS has established a regulatory compliance program for
bio-safety, select agent and toxin security, and the care and
use of animals in research. DHS's select agent and toxin
research is subject to the regulatory control of the Centers
for Disease Control and Prevention and Animal and Plant Health
Inspection Service. At DHS, we conduct significant additional
oversight because of unique sensitivities related to bio-
defense research, as distinct from conventional public health
research.
The regulatory compliance program is significantly driven
by our treaty compliance efforts. Laboratories conducting
Category 2 or 3 projects are subject to onsite inspections.
Other laboratories are visited because we have some indication
that there may be problems with non-compliance.
To assist the Under Secretary in exercising original
classification authority, the Science and Technology
Directorate established the Classification Review Panel, which
I co-chair with the Director of Security. DHS has a significant
priority in maintaining openness in life science research, but
the nature of bio-defense threat characterization studies
requires that some elements remain classified to protect the
public from harm. The Classification Review Panel co-chairs are
responsible for ensuring that all Science and Technology
Directorate programs have, and are appropriately applying,
classification guidance.
In conclusion, DHS has an exceptionally effective record at
strengthening biological safety and security in DHS-funded
laboratories. I thank you for your attention and I would be
pleased to take any questions you may have.
[The prepared statement of Mr. Pasco appears as a
submission for the record.]
Senator Cardin. Well, once again, let me thank all three of
you for being here and the work that each of your agencies do.
I have been to Detrick, as I said in my opening comments. I've
seen the work that's being done there, the dedicated men and
women who are serving our country in a very dangerous
situation, and we very much appreciate their professionalism
and their dedication to trying to deal with these extremely
difficult subjects.
I know that we have a working group that is prepared to
make recommendations, or at least make a report to the
administration, and we're looking forward to receiving that
report. Quite frankly, we thought it would be available by now,
but we do have at least some of the information that's coming
out of their work, which I think is useful for us today.
Let me just raise the first fundamental issue. There are
about 15 Federal agencies that deal with labs and no one agency
has primary or full responsibility here. So I listened to your
testimony. I see Department of Justice indicating that they've
done Security Risk Assessments on about 32,000 individuals.
I listened to what Department of Homeland Security said,
that they're dealing with 42 labs and have done 23 onsite
inspections. My staff tells me that when we take a look at the
information on select agents regulations, that there are 390
entities that have gotten registered, with 15,000 employees. So
these numbers seem to be not totally consistent.
I guess my concern is, I don't know who to ask the question
for in the Federal Government as to, where are the labs? Are we
satisfied they're properly secure, that are dealing with agents
that we have concerns about? Does anyone have a handle on the
inventories we have on these agents, select agents that we're
concerned about? Is anyone primarily responsible to make sure
that we have adequate securities in place dealing with these
labs? Shouldn't we have more direct responsibility?
I know that, again, I expect that the working group is
going to deal with this. We have some recommendations from
other groups that have looked at it. Mr. Pasco, most will turn
to Department of Homeland Security and say that's the logical
place to have the responsibility. I had a chance to talk to
Director Mueller at the FBI. He said his role is pretty
limited. He does the reviews, gets the information out, but
he's certainly not responsible for the labs.
Mr. Pasco. Thank you, Senator. It's an important question
and I understand why you would be concerned. The Department of
Homeland Security is, at this point, a funding agency. That is
to say, we conducted research. My job as the Compliance
Assurance Program Manager is to ensure that that research is
compliant with existing regulatory standards. So we have 42
laboratories that are currently or have recently been involved
in DHS-funded research.
As I indicated, we prioritized those for inspections based
on the nature of the work that's being done there, and then
also if we have reason to think that there may be compliance
issues. But our inspections are essentially under authorities
granted by the FAR, that we would have to inspect work that's
being performed under contract. So we don't have distinct
regulatory authority for this type of thing.
Senator Cardin. I understand that the authority is not
there. The question is, should you have the authority? Should
you be able to track what is happening in our Nation on those
who handle select agents so that we have some understanding of
the training, some understanding of the best practices.
Let me just give you one example. You might visit a lab and
see a procedure that's used for a select agent that is worthy
of being utilized in more labs around this Nation for the
purposes of protecting the workforce and protecting the public.
Is there a mechanism where that information gets out, where we
can share that type of security information? A university may
not be dealing with you. They may not be one of the 42 that
you're talking about, and that's certainly one that you haven't
inspected, but they may be dealing with the same pathogens. How
do we coordinate and make sure that we are dealing with these
pathogens in the safest possible way? Mr. Reed?
Mr. Reed. Sir, the Centers for Disease Control, Department
of Health and Human Services, and the Animal and Plant Health
Inspection Service, Department of Agriculture have the
responsibility for inspecting all facilities for compliance
with the select agent programs and maintain----
Senator Cardin. How did I know that you would mention one
of the agencies we didn't have at the table today as the
responsible----
[Laughter.]
Mr. Reed. Well, you know, it gives the staff something to
work on.
Senator Cardin. We could have had 15 of you up there. My
point is, there's 15 agencies that do have some responsibility.
Mr. Reed. Right. And I want to come to that point in just a
moment. Those two activities maintain a listing of each
Biological Select Agent being operated on at each laboratory,
the personnel who are cleared for handling of BSAT and
inventories, and approve transfers of BSAT between
laboratories. What we have been doing as a body within the
interagency for about a year now is to review these issues.
(And you just alluded to the report that has been provided in
draft to the administration in response to the President's
Executive Order is going through its final coordination with
the interagency.) There needs to be, clearly, someone in
overall charge of directing that oversight.
All of the reports that are coming forward note the need
for activity that can bring that all together. But what we're
looking for, quite frankly, is the development of, if you will,
a set of minimal requirements in terms of personnel
reliability, accounting, security, training, best laboratory
practices that take into account the views of all the
stakeholders, and then bringing that together and saying, okay,
here's what we have done that does represent that balance
between the critical elements of security for the select
agents, which quite frankly are of varying degrees of
virulence. So, you might come out with the idea of a stratified
system that one might use.
Senator Cardin. The Commission to prevent the proliferation
of weapons of mass destruction has suggested a tier approach.
Mr. Reed. Yes.
Senator Cardin. I think there are 80 agents today that are
of concern that are under the regulation. They are suggesting
tier one would be about eight.
Mr. Reed. Yes, sir.
Senator Cardin. Does that make sense? Does that make it
easier for you to be able to really track those agents that are
of the most concern, those pathogens that require much closer
scrutiny on inventory and access?
Mr. Reed. With my colleagues who have been participating in
those studies, there would be agreement--yes, there would be.
It then becomes a question of, what goes in what bin: the
guidelines for what in terms of the BSL Levels I through IV
agent categories.
Senator Cardin. Mr. Roberts, you talked about the
background checks that you do in regards to the regulations. If
I understand that correctly--and you were very clear, it's not
at all the same as what we do for people who need clearance.
That's a different type of a background check--it seemed like
what you were describing is mostly getting information from the
applicant and checking your data bank.
But do you actually go out in the field? Do you do
interviews? Is there anything more done as far as checking the
person's psychological capacities, weaknesses, or checking
their sources to make sure that it's accurate, the information
they've given you, which is what we do on clearance where there
is more direct contact?
Mr. Roberts. You're right, Mr. Chairman. There is quite a
bit of difference between what we do for an SRA and what we
would do for a Top Secret security clearance, for example. No.
To answer your question, we don't do any interviews,
neighborhood interviews or interviews of friends or associates
of the individuals. We do more than just data base checks of
FBI data bases. We, for example, will check the terror
screening center data bases, which has access to the entire
intelligence community. Much of it also filters through ICE and
their law enforcement center in Vermont as well, so it's not
just the FBI data base.
However, I will tell you that the FBI has a very robust
fingerprint data base, maybe the most robust in the world when
it comes to criminals being stored--fingerprints being stored.
We have 60 million-plus fingerprints of subjects on record with
us at CJIS in West Virginia. So it is a wealth of information
that we do tap into when we receive the individual's SRA
package. That's the first place we will start, but it isn't the
last. But you are correct, sir, that it is just a data base
check. We do not do further checks in terms of information of
the individual more than data bases.
Senator Cardin. And after the person has been cleared by
the review that you do, what would trigger you looking at that
person again, if anything?
Mr. Roberts. There is something. Actually, what we do is we
put a stop on the individual's fingerprint records. So if, for
example, any of the 18,000-plus law enforcement agencies that
are in the United States were to arrest an individual who had
been through an SRA, we would be notified of that. We place
what would be a stop in our systems so that we are notified
anytime they are arrested, and then we would then notify the
sponsoring agency of that arrest.
Senator Cardin. So you're actually putting their
fingerprints into the data bank then, I take it?
Mr. Roberts. We're actually putting stops into the data
bank, yes. We're not putting their fingerprints into the whole
criminal data base, no. We're just putting stops against them,
their names.
Senator Cardin. So it's a name? I'm a little confused as to
how that would come----
Mr. Roberts. Yes. I'm sorry.
Senator Cardin. How would they know that's the person?
Mr. Roberts. Yes. It would be a biographic. It would be a
biographic, not a biometric. It would be a name search.
Senator Cardin. And then you would confirm that's the right
person before, I take it, you would take action?
Mr. Roberts. Absolutely.
Senator Cardin. But as a matter of routine, if the person
was hospitalized for a mental condition, that would not come to
your attention, would it?
Mr. Roberts. That is correct, sir. That is a gap in the
system. If you ask my personal opinion, we have no national
data base of mental health records that we can lean on. As you
know, we also manage the firearms check program for the FBI as
well, and that is also a prohibiting factor for purchasing
firearms.
We have some records that have been submitted to us in the
firearms programs from hospitals, such as the VA hospitals, for
example, but we are not allowed to share, by law, that firearms
individual with the BRAG group that does the SRAs.
So you're correct in that there's a gap there, that we rely
a great deal on the person's self-admission to a mental
problem. There are some criminal histories which do identify
the fact that the individual arrested may have a mental
deficiency if you query that person and they have a criminal
record, but beyond that, there isn't much information there
available, other than what the person self-reports.
Senator Cardin. So let me come back to Mr. Reed for a
moment. If we were to use a tiered approach as far as
regulatory responsibilities, is it conceivable that the
background check could be--you could differentiate between
those that are handling the pathogens that are in tier one to
require a more sophisticated background check for those that
have access to those types of agents?
Mr. Reed. I think, Senator, that would quite possibly be
something one might choose to employ. You would also have
different levels of security in terms of how the agents are
handled and stored. In all cases, there would have to be the
matter of training of the individual investigator in terms of
the safety and security that had to be employed within the
laboratory, and there could be very well gradations of that.
One example that has been used in transferring from the so-
called ``two-man'' rule of nuclear practice--nuclear weapons
practice or of chemical weapons practice, where you had to have
two fully qualified individuals, one to check the other and to
report on the other.
There are cases, particularly in terms of working with the
Level I biological agents, if you will, in particular, where
(in order to reduce the potential for exposure and reduce the
potential for a mistake, one worker getting in the way of the
other while working in a quite tight situation) you would have
a single individual, but under observation remotely. So there
are a whole series of gradations that could be applied, but the
issue of training, of oversight by the supervisors and peer
review, and then self-reporting if an individual felt that they
were getting stressed out and incapable of operating properly.
Senator Cardin. I think that's very--that's the types of
observations I think we need to take a look at. The burden to
have you do security clearances on every person that would be--
you couldn't handle that, I understand that. But I think we
have to have a more sophisticated way in which we look at those
that are handling the most dangerous of the pathogens.
I think there are some common-sense ways that we can
differentiate here and could have that done. I know at Ft.
Detrick there was an issue concerning the inventory of the
pathogens. I don't know who I want to ask this question to.
It's not really specific to Ft. Detrick. It's more general as
to inventory.
Are you confident that we know where these pathogens are in
this country and that we have inventory controls, and that if
something is missing there are adequate procedures in place to
find out where those pathogens are at all times? It's really, I
think, a Homeland Security issue more so than a specific
agency, but I'd be more than happy to let Defense also have a
crack at it.
Mr. Pasco. Thank you, Senator. For DHS-funded programs, we
spend quite a lot of attention on inventory issues. It's one of
the reasons----
Senator Cardin. That's not the real question. The real
question is, Homeland Security is responsible for homeland
security. We don't really care whether you're giving money to a
different group or not. If they have control over a pathogen
that can be used for biological mischief to America, we want to
make sure that you know where that pathogen is at all times, at
least our government knows where those pathogens are at all
times.
Mr. Pasco. Thank you, sir. You're right, that is the
question that is underlying it. The Department of Homeland
Security only has visibility into the programs that we fund as
far as pathogen inventories. Of course, all of the select agent
inventories are subject to Centers for Disease Control and
APHIS regulatory process, but the Department of Homeland
Security only reviews inventory processes of our own
laboratories and programs that we are funding.
Senator Cardin. Well, that's clearly inadequate. I assume,
DOD, you take responsibility for your own labs? Is that what
you're----
Mr. Reed. Yes, sir. But also in the context, we are subject
to the CDC and APHIS oversight. But it really becomes a
question of discipline and a culture of safety and security at
the individual installations. Of course, they're subject to
inspection on an annual basis by the other two activities, and
DOD labs in particular, and John Skvorak can probably testify
to it, and the subject to inspections within the Department as
well.
The key issue from my perspective--and I hearken back to my
experience as an artillery battalion commander--is standards--a
common set of standards that one can work towards--and a common
set of inspections and inspection criteria. In order to
facilitate the research, a common view is that there be a
minimum standard possible in order to give you the flexibility
you need, but it needs to be a standard that we apply and that
we arrive at, I think, administratively and through rulemaking,
as opposed to through legislation.
Senator Cardin. Yes. Certainly?
Mr. Reed. John, do you want to comment on that at all?
Colonel Skvorak. I think, Senator Cardin----
Senator Cardin. Could you just state your name for the
record?
Colonel Skvorak. I'm John Skvorak, Colonel John Skvorak.
Senator Cardin. Yes.
Colonel Skvorak. Mr. Reed, in his opening statement,
explained a little bit of the challenge that biological agents
represent as far as inventory relative to chemical and nuclear,
being naturally occurring and replicating. You know, the
inspections are a very important part of our ability to
maintain an accurate inventory. We have the CDC inspections and
the Army IG inspections. We do 100 percent inventories
annually. We do disinterested party audits of our inventories
within the Institute.
We have different categories of agents as far as long-term
and working stocks that present unique problems, and we have to
find unique solutions to inventory those. We have developed an
in-house data base for us to help maintain and to track
inventory.
Obviously the folks at USAMRID understand how important
inventory is, with the inventory stand-down that we did back in
February through about 4 months for us to complete that
process. It is a difficult challenge, but it is, as also was
said, a cultural change that has to be instituted within the
laboratory. It's a leadership issue and it's something we can
just continue to enforce, continue to monitor, and continue to
use the peer review and outside reviews to make sure that we
can maintain accurate inventories.
Senator Cardin. Well, thank you for that. We will wait for
the recommendations of the in-house working group, but there
really needs to be better lines of responsibility here. I think
we all would appreciate having those lines understood. I think
we also need to differentiate between the different types of
pathogens as far as the degree of interest.
Mr. Pasco, I come back to your point. You're giving money
to a particular entity, let's say, a research lab on a
particular campus. I've been told that there's a lot of
collaboration among different institutions on a lot of the
pathogens, and therefore I assume it's possible, though the
funds go to one lab, there may be more than one lab involved in
the work that's being done.
In fact, it may be done outside the United States. I know
there's a lot of--so I'm not sure I understand your
responsibility, even under the limited requirements, limited
authority that you have. Are you just reviewing the work at the
lab that is the recipient of your grants? You certainly are
not--are you looking at who they're working with? Do you have
any responsibility outside of the United States, if they're
collaborating with an entity outside of our country?
Mr. Pasco. Thank you, sir. Yes. In fact, we follow the
money where it goes through the chain of providers. So it is,
indeed, possible that you would have--for example, NBAC, the
national bio-defense laboratory that we're building at Ft.
Detrick, would have as a subcontractor other companies or
laboratories around the country, and that they in turn might
subcontract with laboratories either elsewhere in the country
or outside of the United States.
That certainly does happen. So it becomes my responsibility
to make sure that we are examining the work where it's being
done. We have not--typically, to address specifically your
point on international work, we do make sure that, to the
greatest extent possible, things are being done in a safe way,
wherever it happens to be done. Is that responsive to your
question, sir?
Senator Cardin. Well, you mentioned 42 labs.
Mr. Pasco. Yes, sir.
Senator Cardin. And that you do physical inspections on 23,
because I assume you have reason--you said you had reason to go
onsite. Are those 42 labs all located in the United States?
Mr. Pasco. Yes, sir.
Senator Cardin. So then, in fact, if the collaboration is
outside of the United States, you really don't have much
ability to follow that money.
Mr. Pasco. Well, what we would likely be doing is probably
a paper-based review. That is to say, we would ask the
laboratory--whether it's in the United States or not, we would
ask them to provide certain basic documents to us. We'd like to
see what their security protocols are, what their safety
protocols are, what is the type of training that they require
for their staffs?
Information could be requested about the basic facility.
And you can learn a lot about the health of a program by that
type of documentation review, and we would use that, whether
the lab was in the United States or not, to understand the
management practices of that facility and whether we would have
a reason to want to send inspectors to physically visit.
Senator Cardin. Let me ask one last question on perimeter
security for our government labs. Is there a uniform protocol
for perimeter security if you're dealing with the Level IV
labs? Is that established? Is there a need for a review of
that, considering the higher risk factors today in regards to
those interested in weapons of mass destruction?
Mr. Reed. Let me attempt to respond to that in a general
sense in terms of what needs to be there, if I may. We have a
bio-defense campus that you're very familiar with that is being
established at Ft. Detrick, where we're having laboratories
from Department of Homeland Security, from the Department of
Health and Human Services, and from the Department of Defense
co-located and contiguous.
If we do not have a common approach to the establishment of
security for that laboratory, that laboratory complex, we will
have three independent laboratories that are not able to
coordinate their activities in the way that I think was
originally intended when that was established in concept.
And so from that standpoint, I think that's one of the key
things that we really need to get to, and then to extend those
sorts of standards, those sorts of requirements really
throughout so we know the way the various materials are being
protected and we have an ability to inspect against that.
I'm going to ask Captain Cole to respond, if I may, just
for a moment from the standpoint of the international issue.
Ken.
Captain Cole. I am Captain Kenneth Cole. I'm the Medical
Director of the Chemical/Biological Defense Program within DOD.
With respect to your question of overseas labs, of course, the
DOD does operate several overseas labs. These laboratories--our
primary mission is bio-surveillance, for the protection of not
only our service members overseas, but for also providing data
for the World Health Organization, as well as our own public
health infrastructure in the United States on emerging
diseases, as well as endemic diseases like the seasonal flu,
among other things.
Part of the agreements we have with the countries which we
participate in is to have full and open collaboration with
those countries in terms of the monitoring and the exchange of
information, as well as exchange and collaboration of samples
with those laboratories. So in those aspects, we do inspect
those laboratories on our own for compliance with select agent
rules and the DOD regulations.
However, we do have to put into certain places waivers to
certain exemptions of the requirements in order to allow, under
treaties and other agreements we have with these countries, the
exchange of information, as well as exchange of samples that
are required to have a rapid response to an emerging or endemic
disease outbreak.
Senator Cardin. Well, let me thank you again for your
testimony and answering our questions. This is an ongoing
interest to our Committee. I know there are other committees in
the Senate that are also interested. We're going to try to
coordinate our response. We clearly are interested in the
recommendations that come out of the working group and we'll
look forward to not only their report, but the administration's
response to those reports.
We will follow up with Health and Human Services to get
their feedback. I know we're all interested in protecting the
security of our country. These labs, they do extremely
important work and we want to make sure there's a working
ability to get the job done, but with maximum protection to the
public and the security of our country. So, thank you all very
much. Appreciate it.
Our second panel will consist of Hon. Bob Graham, our
former colleague and Chairman of the Commission for the
Prevention of Weapons of Mass Destruction Proliferation and
Terrorism. He has spent a total of 38 years in public service;
a two-term Governor of the State of Florida, before serving for
18 years in the U.S. Senate. He's also spent 12 years in the
Florida State legislature. Senator Graham is recognized for his
leadership on issues ranging from health care and environmental
preservation to his 10 years of service on the Senate Select
Committee on Intelligence, including 18 months as its chair
from 2001 to 2002.
We also welcome Dr. Nancy Kingsbury, who's the Managing
Director for Applied Research and Methods at the U.S.
Government Accountability Office, where she is responsible for
managing GAO's advanced analytical staff, including economists,
computer engineers, statisticians, social scientists, analysts,
program evaluation experts, and scientific specialists.
And last, let me welcome back Michael Greenberger, who's
the Director of the Center for Health and Homeland Security at
the University of Maryland, and a professor at the School of
Law. The center works on a broad range of homeland security and
emergency response issues for the Federal, State, and local
governmental agencies, as well as medical researchers. It's a
pleasure to have all three of you.
As is the tradition of the Judiciary Committee, if I could
ask you to stand for the oath, and then we can get on with your
testimony. Thank you.
[Whereupon, the witnesses were duly sworn.]
Senator Cardin. Thank you all very much. Please have a
seat.
Senator Graham, it's a pleasure to have you back here in
the U.S. Senate. I miss your good advice that I remember with
fondness, working with you when I was in that other body that,
quite frankly, I don't understand why we need today now that
I'm over in the Senate.
[Laughter.]
Senator Cardin. But it's a pleasure to have you before our
Committee.
STATEMENT OF HON. ROBERT GRAHAM, FORMER U.S. SENATOR FROM
FLORIDA, CHAIR, COMMISSION FOR THE PREVENTION OF WEAPONS OF
MASS DESTRUCTION PROLIFERATION AND TERRORISM, WASHINGTON, DC
Senator Graham. Thank you very much, Mr. Chairman. And no
comment on your last comment.
[Laughter.]
Senator Graham. Mr. Chairman, I appreciate the opportunity
to testify before your Subcommittee today.
First, a little background. The Commission that I chair was
founded by the Congress at the suggestion of the 9/11
Commission, which had found that the ultimate catastrophe for
this country would be when the worst weapons fell into the
worst hands. The response of the Congress was to establish a
commission to review our current policies to avoid
proliferation and make recommendations for the future.
We did so in a report entitled, ``World At Risk'', which
was published in December of '08. Then the Congress asked us if
we would stay for another year and work with it, as well as the
administration, in implementing our recommendations, which we
were honored to do, and I appreciate the opportunity that you
are affording me today on behalf of the Commission to do so.
I would like to use my time to give somewhat of an overview
of where I see the issue of biological weapons fitting into the
larger picture of preventing the proliferation of weapons of
mass destruction.
Mr. Chairman, our Commission made three basic findings.
One, that since 9/11, we have become less safe, not because we
have not been diligent in executing policies designed to
increase our security, but because our adversaries have been
moving at a more rapid pace and the environment in which this
competition is occurring gives an advantage to the kind of
people that our adversaries are.
The second finding was that, without urgent action, that it
is more likely than not that a weapon of mass destruction will
be used someplace on earth between December 2008 and the end of
2013. That was an assessment reached after consultation with a
wide range of scientific, intelligence and law enforcement
experts in this country and abroad. We were given some
underpinning in that recommendation when, two weeks after our
report was issued, the then-Director of National Intelligence,
Mike McConnell, made almost precisely the same prediction.
The third, is that a weapon of mass destruction is more
likely to be a biological weapon than a nuclear weapon, for
reasons that I will comment on in my further statement.
I believe that there are three clocks running. The first
clock is a 2013 clock. As I stated, the Commission concluded
that it was more likely than not that a weapon of mass
destruction would be used by 2013. The second clock is a 2010
clock. Under the principal international treaty for nuclear
proliferation avoidance, the nonproliferation agreement, there
is, every 5 years, a meeting of the signatories to review
what's happened in the last 5 years and make recommendations
for the future. 2010 will be such a year. We believe it is
critically important that 2010 be used aggressively to deal
with some of the current gaps and weaknesses in our
international treaty on nuclear proliferation.
That issue is primarily in the executive branch. The
Congress has legislated extensively in the area of nuclear
proliferation. Most of the heavy lifting to be done must be
accomplished by the executive branch. I'd like to commend
President Obama for his initiative, the statements that he has
made, such as that that he made in Prague, and calling for a
summit in March of 2010 to precede the conference of the
signatories to the nonproliferation treaty that should energize
the work of that conference.
The third clock is a 2011 clock. As the nonproliferation
treaty is the basic document for nuclear nonproliferation, the
Biological Weapons Convention of 1972 has the same role for
biologicals. It also has provision for periodic review. The
next review will take place in 2011.
We believe it is imperative that the United States use its
influence in order to achieve some significant reform in the
structure of our dealings with biological proliferation. In
many ways, the biological treaty is in greater need of amending
than the nuclear treaty. We also believe that, for the United
States to play that role of leader, we must lead by example.
This issue is primarily a Congressional issue. We believe
that the legislation that Congress, hopefully, will enact in
the next few months will set the gold standard of what a
country should do to avoid the proliferation of biological
weapons, and that that will put us on the moral high ground as
we go into the 2011 convention to get other countries to see
our standard as one to which they should also aspire.
Mr. Chairman, we have felt that there were two principal
strategies for biological defense against proliferation. One,
is very similar to the basic strategy for nuclear, which is to
avoid the terrorists getting access to the materials necessary
to make, and then distribute and disseminate, biological
materials.
This is a much more difficult issue in biological than it
is in nuclear because the biological materials are so
ubiquitous, and they do not require the same skill level or the
technology. They can be transported more readily; a mere vial
of the right pathogen can do enormous damage.
The second strategy which is peculiar to biologicals is a
deter-by-being-prepared strategy. In our discussions, including
some recent discussions within the intelligence community, the
feeling is that if an adversary, particularly a non-state
actor, were to get access to the materials for a weapon, they
would use it fairly quickly.
Unlike North Korea, which has a strategy of stockpiling the
nuclear bombs that it's developing because they want to have a
second-strike capability, a typical non-state terrorist would
want to use the material quickly, in part because of safety
concerns, and second, because it fulfills their rationale for
wanting to use a weapon of mass destruction.
The adversary would be looking at a number of potential
targets to use their biological materials. We think that they
would be inclined to want to use it against the target where
they felt they would have the greatest consequence, the
greatest number of casualties. So the degree to which a
community has prepared itself not only for a terrorist attack,
but also for an epidemic, such as what we might be dealing with
this year with swine flu, that preparation is one of the best
deterrents that a community can have. The issue that you're
discussing today, lab security, touches on both of those
strategies.
Lab security is a fundamental part of preventing weapons of
mass destruction from falling into the wrong hands. Also, lab
security procedures play an important role in our continuing
ability to be creative and innovative in developing the
vaccines and other pharmaceuticals that will be a key part of
our ability to reduce the consequences of the use of a
biological weapon of mass destruction.
Mr. Chairman, that is sort of the broad framework. I would
just conclude by mentioning three areas of action. One, the
need to have an overall strategy of how we're going to deal
with the biological issue. I testified earlier today where a
representative of the Government Accountability Office
presented a report which had the headline of, ``We Do Not Have
Anyone in Charge of Our Biological Response.'' It's now been 8
years since the attack that occurred, in part, in this very
building, was launched. It is inexcusable that we don't have an
overall strategy, and I think it's incumbent upon the Congress
to take those steps to demand that the executive branch
establish such a strategy.
Second is the international dimension. The title of our
report was consciously selected. It is: ``World at Risk,''
underscoring the fact that this is not a problem that the
United States can solve in isolation. We've got to see this as
a global threat. The 2011 conference, and our preparation for
it, will be key.
Finally, returning to the three clocks, we don't have an
indefinite amount of time. This is my assessment, not the
Commission's. The Commission assessed that, as of December
2008, there was better than a 50/50 chance that there would be
a weapon of mass destruction used between that date and the end
of 2013.
It would be my assessment today, on the 22nd of September
of 2009, that the chances of there being a successful use of a
weapon of mass destruction are greater than they were even last
December. That is a testimony to the alacrity and the
commitment of our opponents, our adversaries, to achieve and
use this technology.
So, Mr. Chairman, I thank you for the opportunity to share
these thoughts on behalf of the Commission. I would be pleased
to answer any questions.
[The prepared statement of Senator Graham appears as a
submission for the record.]
Senator Cardin. Well, again, thank you very much for your
testimony. It's very, very helpful.
Dr. Kingsbury.
STATEMENT OF DR. NANCY KINGSBURY, MANAGING DIRECTOR, APPLIED
RESEARCH AND METHODS, UNITED STATES GOVERNMENT ACCOUNTABILITY
OFFICE, WASHINGTON, DC
Dr. Kingsbury. OK. I'll try to be brief, if I can get my
microphone on.
We're very pleased to be here to discuss the report that we
issued yesterday on the need for a national strategy for high-
containment laboratories in the United States. High-containment
laboratories have proliferated in recent years. In 2007, we
reported on several issues associated with the proliferation of
these labs in the United States, and some of the risk posed by
bio-safety incidents that occurred in the past.
The FBI's allegation in August of 2008 that a DOD scientist
was the sole perpetrator of the 2001 anthrax attacks raised
additional concerns about the possibility of insider misuse of
high-containment laboratory facilities, material, and
technology.
Highly publicized laboratory errors and controversies about
where high-containment labs should be located have raised
questions about whether the governing framework, oversight, and
standards for bio-safety and bio-security are adequate.
We have three findings to report. First, since 2001, the
number of BSL-III and BSL-IV labs in the United States has
increased, and this expansion has taken place across Federal,
State, academic, and private sectors. By increase, we have some
data in our report that would suggest it's more than doubled in
terms of the numbers.
Information about the number, location, activities, and
ownership is available for high-containment labs that are
registered with CDC's or USDA's select agent programs, but not
for those outside those outside those programs. The expansion
that began after the anthrax attacks in 2001 lacked a clear,
coordinated national strategy.
Decisions to fund the construction of high-containment labs
were made by multiple Federal agencies in multiple budget
cycles. Federal and State agencies, academia, and the private
sector considered their own individual requirements, but an
assessment of national needs was lacking. Even now after more
than 7 years, we were unable to find any projections based on a
government-initiated strategic evaluation of current and future
capacity requirements linked to national public health goals,
or for that matter, weapons of mass destruction goals. Such
information is needed to ensure that the U.S. will have
facilities in the right place with the right research
capabilities.
Second, no executive or legislative mandate directs any
Federal agency to track the expansion of all high-containment
laboratories. Accordingly, no Federal agency knows how many
such labs exist in the United States, and no single agency is
responsible for determining, or able to determine, the
aggregate risks associated with the expansion of these labs.
Consequently, no Federal agency can determine whether high-
containment lab capacity is now less than, meets, or exceeds
the national need.
Finally, four highly publicized bio-safety incidents in
high-containment laboratories, as well as evidence from
scientific literature, demonstrate that, while laboratory
accidents are rare, they do occur, primarily due to human error
or system failure. One of the incidents we reviewed involved
the allegations that Dr. Bruce Ivins of DOD was the source of
the 2001 anthrax attack.
These allegations highlighted two lessons: first, an ill-
intentioned insider could pose a risk by removing dangerous
material from a high-containment laboratory; and second, it is
impossible to have 100 percent effective inventory control of
biological material with currently available technologies.
At Ft. Detrick, ineffective procedures for the control of
inventories and the unrestricted use of lab facilities
allegedly allowed Dr. Ivins the opportunity to pursue his own
ends. As the number of high-containment labs increases, there
will inevitably be an increase in the pool of scientists with
expertise and, thus, the corresponding risk from insiders is
likely to increase.
Taken as a whole, the incidents we reviewed demonstrated
failures of systems and procedures meant to maintain bio-safety
in high-containment labs. They revealed the failure to comply
with regulatory requirements, safety measures that were not
commensurate with the level of risk to public health posed by
lab workers and the pathogens in those labs, and the failure to
fund ongoing facility maintenance and monitoring the
operational effectiveness of lab physical infrastructure.
In conclusion, I want to stress that oversight plays a
critical role in improving bio-safety and ensuring that high-
containment labs comply with regulations. However, some aspects
of the current oversight programs provided by CDC and USDA are
dependent upon entities monitoring themselves and reporting
incidents to Federal regulators.
Furthermore, personal reliability programs have been
established since 2001 to counter insider risks, but their
cost-effectiveness and programmatic impact has not been
evaluated. We would note that the incident at Ft. Detrick is
the only known incident of insider behavior.
If an agency were tasked or a mechanism were established
with the purpose of overseeing the expansion of high-
containment labs, it could develop a strategic plan to ensure
that the number and capabilities of potentially dangerous high-
containment labs are no greater or less than necessary, it
could balance the risks and benefits of expanding such labs,
and it could determine the type of oversight needed.
To address these issues, we recommended that the National
Security Advisor, in consultation with the Secretaries of
Health and Human Services, Agriculture, Defense, and Homeland
Security, along with the National Intelligence Council and
other executive departments as appropriate, identify a single
entity charged with periodic strategic evaluation of high-
containment labs that will determine the number, location, and
mission of the laboratories needed to effectively meet national
goals to counter bio-threats, the existing laboratory capacity
within the United States, the aggregate risks associated with
the laboratories' expansion, and the type of oversight needed.
It would also develop, in consultation with the scientific
community, national standards for the design, construction,
commissioning, and operation of high-containment laboratories,
specifically and importantly including provisions for long-term
maintenance.
We also recommend that the Secretaries of HHS and
Agriculture develop a clear definition of exposure to select
agents. The voluntary reports that come back from labs
obviously demonstrate that there is some confusion about that
issue. They can also develop a mechanism for sharing lessons
learned from reported laboratory accidents so that best
practices for other operators of high-containment laboratories
can be identified.
Recognizing that biological agent inventories cannot be
completely controlled at present, we also recommended that the
Secretaries of HHS and Agriculture review existing inventory
control systems and invest in, and develop, appropriate
technologies to minimize the potential for the insider misuse
of biologic agents.
Finally, should the Secretaries consider implementing a
more stringent personnel reliability program for high-
containment laboratory employees to deal with insider risk, we
recommend that they evaluate and document the cost-
effectiveness and programmatic impact of such a program. In an
earlier hearing today, a representative of the American Society
for Microbiologists emphasized quite a bit the need to balance
the security factors and the ability for researchers to do
their work.
Mr. Chairman, that's my prepared statement and I'll be
happy to answer your questions.
[The prepared statement of Dr. Kingsbury appears as a
submission for the record.]
Senator Cardin. That's very helpful. Thank you very much.
Mr. Greenberger.
STATEMENT OF MICHAEL GREENBERGER, DIRECTOR, CENTER FOR HEALTH
AND HOMELAND SECURITY, UNIVERSITY OF MARYLAND, BALTIMORE
BALTIMORE, MD
Mr. Greenberger. Thank you, Chairman Cardin. And I want to
congratulate you and the Subcommittee for holding this hearing
today. If we've learned any lesson from our National security
perspective, and maybe even from our financial perspective, is
that when you don't pay attention to issues we tend to get
banged in the side of the head. You can go all the way back to
the Great Depression and Pearl Harbor or you can look at the 9/
11 attacks or the anthrax attacks.
I know the Senate's docket is very, very busy, and I know
that, for example, Ranking Member Kyl is understandably
preoccupied with health reform, and you've got global warming,
reform of the Financial Regulatory System, and a host of
international relations issues, Afghanistan probably being at
the top. But I think your Subcommittee's wisdom in looking at
an issue that can come back to bite us big-time is to be
congratulated.
I have had the fortune, as the Director of the Center for
Health and Homeland Security at the University of Maryland, of
working with medical researchers at the School of Medicine and
their collaborative, the Mid-Atlantic Regional Center of
Excellence, which deals with bio-defense and emerging
infectious diseases issues.
Let me say in the first instance, the money that is being
spent by the Federal Government for this research is money that
is well spent. We only have to look at the fact that we are
going to have an H1N1 vaccine in October. When things go well
we don't tend to congratulate people. The fact that that
vaccine is available, given scientific and commercial problems
in the vaccine industry, is nothing more than a minor miracle
and shows what scientific research can do to be of assistance
to the United States.
However, the anthrax episode at Ft. Detrick demonstrates
that, imbedded within all of that good work can be very
dangerous activity. It is a high irony that the anthrax episode
of 2001 was the principal motivator for all of this research,
and then we found out a year ago that the researchers may have
been the problem of the anthrax incident itself.
Now, let me say, I have studied the Ft. Detrick situation.
I'm not at all convinced that Dr. Ivins is necessarily the
perpetrator, and I think it was unfortunate that, after his
suicide, blame was heaped upon him. But I am convinced, based
on the DNA evidence that was done, that the source of the
anthrax emanated from a flask at Ft. Detrick. Somebody got
access to that information.
And while Senator Graham makes the excellent point that we
have to worry about outsiders doing damage to us, this provokes
the classic Pogo commentary that ``We have found the enemy and
he is us''. It was an insider, one of our researchers, that
perpetrated maybe the third serious terrorist attack on the
United States that got access to that flask.
I think we have, in our testimony to you today, made six
recommendations. I think there is a consensus here: you must
have somebody in charge of this situation. I would take some--I
would quibble somewhat with the DOD's testimony today. I think
having an interagency task force do this is a big mistake. I
think putting it in the National Security Council is a big
mistake.
If there were a spill, or the stealth of, say, Ebola
bacteria from a laboratory, somebody in Congress would right
away want to know, what has happened? I think what we've
learned today is, we wouldn't know which of the 15 different
agencies in the Federal Government to call up here, and we all
know the difficulty of getting the National Security Advisor up
here. No blame to the National Security Advisor, but he has a
lot of things on his plate. There must be somebody in the
Federal Government that assumes overall responsibility.
The BSL labs, unlike any professional institution, are not
required to be accredited. Right now, my own law school is
worried about an accreditation process that is going to happen
over a year from now. That is forcing our school, medical
schools, all kinds of institutions who have to be accredited to
do the most thorough self-evaluation to meet that
accreditation.
The single regulator must set up an accrediting process.
We've heard that there's 1-year inspections, some inspections,
what have you. But the four big episodes that are identified as
the cause of our concern, starting with anthrax and some of the
other universities, were people reporting to a regulator a
problem, not the fact that the inspectors found the problem.
You have to have a system that goes through an accreditation
process.
Also, what has been said today, we agree with: mishaps at
the laboratories are not promptly and fully reported to the
Federal Government, and even worse, the experience from those
mishaps is not sent out to the other laboratories as a
``lessons learned'' modality. It's a very incomplete process
and it's a very slow process, and again, a single overseer
could fix that problem.
The final thing that's been talked about today that I think
is very important, you have military laboratories on one
extreme and university laboratories on another extreme. It is
impossible--and I was pleased to see the Department of Defense
advocate--to apply military precision and security to a
university laboratory, not just because you don't have the
resources, but most medical researchers at universities would
say that there is an element of the openness of those labs that
would be defeated by a super-security process.
I think many people have testified, some of the committees
that have issued reports today have testified, that you can
reach the security goals here without developing a full
military security apparatus, and not using some of the
techniques like psychological testing of researchers and other
things that would only hinder being able to bring the best
researchers to the table.
I've cited the University of Maryland, Baltimore. They
supervise 1,500 laboratories, some of them are BSL
laboratories. They use guidelines that have been developed by
CDC and NIH. They are very serious about the work they do.
Those guidelines can be applied institution to institution to
assure safety and security. There has never been a leak or
stolen materials from the BSL. That's the next-highest secure
laboratory at the University of Maryland. Through a single
regulator, accreditation, the use of the best practices within
university industries, we can have the best of both worlds:
good science and good security.
Thank you.
[The prepared statement of Mr. Greenberger appears as a
submission for the record.]
Senator Cardin. Well, thank you very much. In fact, thank
all three of you. It's a pretty direct presentation of the risk
factors that we confront. Senator Graham, I think it's very
sobering, your predictions that your Commission came up with,
the vulnerability of the United States to weapons of mass
destruction, and most likely the biological being the more
likely vulnerability. It puts additional attention on the
subject that we have here today, which is the security of our
containment labs.
You all are raising the same point. You're saying we need
to have a coordinated strategy. That is one of the points that,
Senator Graham, you pointed out that is missing, an overall
strategy. It's difficult for us to look at who is responsible
on biological containment labs' security when there's 15
agencies involved and they each have different
responsibilities.
Quite frankly, some of these labs are dealing with a lot of
agents that are not a particular interest, or they're important
to keep control over them, don't get me wrong, but they're not
going to fall into the category that you are concerned about,
Senator, about being used as a weapon of mass destruction.
That's why I thought one of the recommendations I believe
that your Commission has made that I found very helpful is to
have tiers of interest in regards to the agents, the pathogens
that are of the most concern, tier one, would be categorized in
that way so it would get the special attention. Then you could
do what Mr. Greenberger is suggesting as far as being able to
trace those types of agents.
At the same time, I am concerned with the point that Dr.
Kingsbury raised about, how do you do this in a climate that
allows the type of collaboration among our universities and
private entities and international partners that are going to
be important for the type of academic work necessary to prepare
us, as you pointed out, so that we are prepared to deal with
the risks that are out there.
So let me start off with that recommendation on the tiering
of the pathogens. The previous panel seemed also to support
that type of concept. You indicate you might be able to limit
to eight--at least that's what I thought I saw in the
Commission's report. Is that a reasonable number that you think
would end up in tier one? And what is your criteria for tier
one?
Senator Graham. Mr. Chairman, the criteria for inclusion in
tier one are those pathogens that are the most deadly and the
most readily weaponized. The scientific community that we
consulted with felt that that might be as few as eight
pathogens. There are now, I think, over 80 that are on the
special agent list, so it would be a very focused group of
pathogens which could have the highest level of security.
We also propose that there be two other tiers, a tier two
which would be those pathogens that have great potential, but
are not at this point as amenable to weaponization as those
that would be in tier one. They would get the second level of
review. Then tier three would be everything else, including
some items that are of lesser potential threat, but maybe more
ubiquitously distributed around the world.
Senator Cardin. And I want to point out, I think we need
protection on all of the pathogens because it could be
extremely dangerous for those who are handling it. It may well
not be suitable as a weapon of mass destruction, but it is an
agent that requires special attention. We should know where
they are, how they're being used, and there should be certain
standardized protections.
Senator Graham. Yes. I think there is a difference between
the regulatory pattern for safety, which might be more common
across those three tiers. As an example, there was a story
yesterday or today about a scientist at the University of
Chicago who has died, and there is the possibility that he died
because he was handling an agent which is generally thought of
to be relatively mild in terms of its potential. We'll learn
more about the full circumstances of this gentleman's death.
But safety is one concern for which there's probably not
the need or desirability for such high levels of
stratification, but the security level, we want to be able to
put our maximum attention on those pathogens that have the
greatest potential to be converted into weapons.
Senator Cardin. Dr. Kingsbury, you raised the issue of the
freedom, academic freedom and the ability to work with your
colleagues around the world. How do you balance that?
Dr. Kingsbury. Well, I think it's just a factor that needs
to be taken into account. With respect to the tiering question,
while I have a fair amount of sympathy for the importance of
the security of those highly vulnerable pathogens, I'm not sure
we know enough about the mix of pathogens in different
laboratories to have a view yet of whether that kind of
strategy would actually work. If you're working with anthrax or
whatever else is on that list of eight, but you're also working
on something else that's more benign or not likely to--or there
are treatments for it, and so they're inventing new treatments,
it's not sure how that relationship would work and I'd just be
interested in knowing more about it.
Senator Cardin. I also think we need to know, of all the
people who registered, how many would have had to have
registered for tier one if we had a different registration
system.
Dr. Kingsbury. Yes.
Senator Cardin. I don't know if we know that or not,
because we----
Dr. Kingsbury. We don't, I don't think. Do we? No. OK. We
don't.
Senator Cardin. One of the issues here is budget and
workload as to----
Dr. Kingsbury. Oh, sure. Sure. Absolutely. Several months
ago--a couple of months ago--we issued a report looking at the
question of the building of the national agro and bio-defense
facility that the Department of Homeland Security is proposing,
and there we limited our whole analysis to the issue of foot-
and-mouth disease and whether the Department of Homeland
Security had adequately demonstrated that foot-and-mouth
disease, which does not affect humans--OK, so I don't think it
would be a very good weapon, except economically--whether or
not the ability to control escape of that pathogen from a lab
that is built in the middle of the most prolific cow country in
the country, and we reported, frankly, that we didn't think DHS
had demonstrated that. It doesn't mean it can't be done,
perhaps. I have my own concerns about that. But they haven't
demonstrated it yet, and it's clear they're going to go ahead
with the decision.
But we thought focusing on that, because it is economically
so significant and because the virus is so infectious--it's the
single most infectious virus on the planet. If it starts
getting into cattle herds, the cost associated with both the
trade impact of that event and the cost of cleaning it up is
really important to think about. There may be special
circumstances around some of these other select agents that
might need the same kind of analysis.
Senator Cardin. Mr. Greenberger, you don't believe the best
solution is the interagency approach. Do you have a specific
recommendation as to how the line of responsibility should work
in this area?
Mr. Greenberger. Well, I think the two principal agencies
that have had regulatory responsibility--in other words, DHS
came before you today and said, effectively, they're
supervising researchers. They're overseeing their researchers
in the 42 labs. But the people who have had over-arching
responsibility are CDC and the Department of Agriculture for
plants and animals. I think in all candor, you'd have to say
the record here is that CDC is the superior record. There have
been problems with the Department of Agriculture. It's own
Inspector General has identified it.
This reminds me very much of the Hurricane Katrina problem
when, after the clean-up of Hurricane Katrina, there was this
big debate whether the Department of Homeland Security was in
charge as the then-national response plan indicated, or whether
HHS, because of the public health factors in the clean-up,
should be in charge.
In December 2006, Congress passed the Pandemic and All
Hazards Preparedness Act, took the responsibility away from DHS
and gave it to HHS, and created a separate Assistant Secretary
within HHS to oversee catastrophic public health experiences.
Now, one thing I would say about that: oversight is very
important. It took 13 months to get a Director of that agency.
But I think that that kind of episode--I think this is a public
health situation. I think you should look to HHS as the
overriding regulator here. They should be in charge.
Whether CDC, who's now overloaded with H1N1 problems, has
enough resources to do this, I don't know, but I would start
with them. They should be established--they should be the
single agency setting up standards, both safety standards,
security standards for all these laboratories, having the
entire inventory, being responsible for having evidence of
mishaps, and setting up an accreditation process. And by the
way, the accreditation process doesn't necessarily have to be
completely public. You can get the best universities who have
proven laboratory experience here to be the accrediting
committees, and change them from time to time.
As I said, your worry about the tension between security
and openness, I think, is being met in the vast majority of
universities who have laboratory issues today. They are
following NIH/CDC guidelines, they are deadly serious about a
deadly issue, they have training programs, and they hold their
researchers accountable. As the National Science Advisory Board
on Biologics report says, we have to get that culture in the
good institutions imbedded throughout. The single regulator
should be the one who does that. It can be done without
converting universities into military operations.
Senator Cardin. I think we all agree with that.
I think, Senator Graham, your report sort of points to
Department of Homeland Security as the key agency.
Senator Graham. Our recommendation in this area, Mr.
Chairman, is on page 29 of our report. It says, ``The
Department of Health and Human Services, in coordination with
the Department of Homeland Security, should lead an interagency
effort to tighten government oversight of high-containment
laboratories. So our recommendation was that it be interagency
in nature with the Department of Health and Human Services in
the lead.
In addition to the factors that Professor Greenberger has
just outlined, I would add another: that is, urgency. It would
be our hope that the Congress would act in sufficient time that
the administration could show some actual results of your
actions in terms of standards for high-containment laboratories
before that 2011 conference.
We think the United States needs to be in the strongest
position of leadership before that conference in order to be
able to have the influence that we think is critical in order
to strengthen the global network against the proliferation of
biological material. We must lead by example.
Senator Cardin. So there is some agreement here between the
two, HHS. How about the GAO?
Dr. Kingsbury. Well, if I could add two things. One is, as
a part of our work on the report that we issued yesterday, we
did talk to all of the agencies who have an interest in this
oversight question. All of them told us they didn't feel they
had the authority to take a leadership role. That's why we
think there is some action that needs to be taken here. It's
the lack of authority to direct another agency how to spend its
appropriations that is the sort of weakness in----
Senator Cardin. That's our responsibility.
Dr. Kingsbury. That's your responsibility.
Senator Cardin. I understand that. That's our
responsibility to clarify. I'm trying to get the best advice,
if there is consensus in Congress to give a lead agency, who
that lead agency should be. It seems like Senator----
Dr. Kingsbury. Well, for exactly the reasons that Dr.
Greenberger said, HHS is at least a leading candidate here. I
would put it at the HHS level, not the CDC level, because of
NIH and the other places in HHS where these laboratories go.
Senator Cardin. So let me just get back to Senator Graham,
then, on what your thought is, using the interagency. But you
still want the responsibility to be with HHS, if I understand
correctly?
Senator Graham. Yes.
Dr. Kingsbury. If I could offer up one other example. We
are aware that the United Kingdom has completely centralized
oversight of these laboratories in an organization called the
Health and Safety Executive. There were two different--like we
have with CDC and APHIS, there were two different organizations
with somewhat different approaches and standards and so forth
dealing with the animal and plant side, and with the human
side, and they made a decision, after the outbreak of foot-and-
mouth disease in Pirbright, to centralize all of it in the
Health and Safety Executive and operate by the same standards.
Senator Cardin. Senator, as I understood, you're suggesting
that this type of action would be very helpful for the United
States to complete prior to going to the review conference?
Senator Graham. Yes. And I think that the Department of
HHS, because of the reasons that have been stated, is the one
most likely to be able to show some quick results of being
assigned this leadership role.
Senator Cardin. Let me ask one last question generally of
whoever wants to respond to it. That is whether it is useful
for us to pursue a more sophisticated way of doing background
checks on those who have access to the most dangerous
pathogens. Mr. Greenberger, you raise a very valid point, that
the attack on our country, the third most serious, was from
within and that the person who--at least, one of the--the
person who has been labeled responsible had certain issues that
could have been discovered through a background or a review of
his current situation.
Is it feasible and the right use of resources to try to
develop a more sophisticated way to license those who have
access to the most dangerous pathogens, or are we in an area
that to do more than is currently being done is probably not
realistic to expect?
Mr. Greenberger. If I can take a crack at that. I think
that the National Science Advisory Board on Biology, which has
one of the big reports on this, if you read their message
between the lines, is that the present system for non-military
facilities, mostly university facilities, has to be fine-tuned.
Some of it is too stringent. Even as the Department of Defense
testified today, there are too many foreign nationals that are
excluded only because they're foreign nationals and not because
they're a threat to the country, and that's hurting our
scientific effort.
Some of the--for example, the Dr. Ivins thing might suggest
that some of the things the military uses as a screening
device, which are psychological profiling, might be
appropriate. I agree with the National Science Advisory
Committee that that is a mistake. I think, anecdotally, many of
us have had the experience of people being disqualified from
national security clearances for unknown reasons for failure of
the psychological profiling, and I don't think there's a lot of
confidence in it.
The National Science Advisory Board, for example, expressly
says that should not be used for the university system. On the
other hand, if you have a single regulator establishing
standards, it certainly would be appropriate to have them
report on somebody who's been experiencing in the real world
some kind of psychological difficulty. Now, that's a very
sensitive issue. It raises all sorts of privacy points.
But here you have to balance the Nation's security in a Dr.
Ivins-like situation against privacy concerns. It's a delicate
balance. But a single regulator, with the advice of an
interagency consultation and the best private minds, I think,
can draw up regulations that assure privacy but do the
reporting so that those kinds of issues do dwell up to the top.
Right now, in fact, all the building blocks are there.
They're spread among 15 different agencies. Nobody--even the
tiering issue, I think, is--I agree that that is a good
response and it could easily be done, but nobody has been
assigned the responsibility of doing it. I think all these
things can be accomplished. You've got to find somebody to take
charge, given them general guidelines.
Senator Cardin. Your point is, you would, as part of this
overall structural change, give HHS the authority to revise or
change the current structure that's in place where the
Department of Justice is doing these background checks for
those that are dealing with agents.
Mr. Greenberger. Yes. And I think that you can set the
goals. The general goal is assuring security without
undercutting private research. You've got the best--the
National Science Advisory Board has already laid out parameters
where this fine-tuning can take place.
Senator Cardin. Do better in some cases, but in some cases
we're over-restricted.
Mr. Greenberger. I agree.
Senator Cardin. Senator Graham.
Senator Graham. I would agree with Professor Greenberger's
assessment. I would also say that, of the various ways in which
the materials for a biological weapon of mass destruction might
fall into evil hands, such as being produced outside the
country and brought into the country, or someone driving a
truck through a fence at a secured facility, or a person on the
inside turning and becoming a rogue scientist, I think that
third option is the most likely option. It happens to be the
only option which has actually been utilized in recent history.
So I think it's a very important question. I would
associate myself with the sophisticated recommendation that the
Professor has made as to how to go about balancing all of those
interests.
Senator Cardin. Doctor.
Dr. Kingsbury. I think we would agree that if you're going
to do a personnel security program with uniform requirements
across the whole community, some kind of collaborative way of
doing it is certainly absolutely needed. But it's not going to
come cheap. As you well know, the government is facing
considerable budgetary pressure these days. I would not want to
think about that personnel security program in complete
isolation.
I think there is not a lot of evidence about its being
successful in what it sets out to do. The case at Ft. Detrick
is the only known case of an insider doing the sorts of things
that he did. Yet, there are, what, 1,600 of these laboratories
around the country. So whether you want to get into the
business of doing that without, as we recommend in our report,
looking at what the costs are going to be, looking at what the
benefits are going to be and evaluating it--we are aware, for
example, of a case at the University of Texas at Austin where
they are trying to hire a couple of very high-end scientists
from Brazil, and they're having to wait 18 months. They haven't
been cleared to come into the country even, let alone to work
at the laboratory. So all those issues need to be worked
through with the scientific community.
Senator Cardin. I don't think we're going to be able to
resolve the problems of people getting visas to come to America
at this hearing.
Dr. Kingsbury. Probably not.
Senator Cardin. But I think you raise a very valid point on
cost. My point is this. I think what Professor Greenberger is
saying is that we might be able to get savings by doing this
more efficiently than we we're doing it today and that, if we
have a tier approach, there may well be a less costly way to
deal with the majority of people that are dealing with
pathogens at our labs or the type of lab they're dealing with,
the type of work that they're dealing with, that there should
be more sophistication in the way that we go about doing it.
I expect, if HHS had the authority, they could then have
more impact on DOJ, if that's the agency that's actually going
to be doing the reviews for the process, and they may be able
to avoid some of the time delays that we have. At least, I
would hope that would be part of the game plan that would be
developed.
But I must tell you, someone who is dealing with anthrax
and the potential danger that that can cause, the potential
risk factor of a weapon of mass destruction, it seems to me
that we have a responsibility to the public that someone who
could have access to remove anthrax from a lab, that that
person is scrutinized at a much higher level, including their
psychological make-up, so that we do protect the public from
that type of attack that we had here in the U.S. Senate and in
our country.
With that, let me thank all three of you for adding to this
discussion. As I said at the beginning, there are other
committees that are interested in this subject, and we do
expect that the Congress is going to want to continue this
effort. I thank all three of you for your contribution.
Senator Graham, the work of your Commission, which was, as
you pointed out, set up by Congress, is a valued part of our
process. There's been a lot of discussion about it among your
former colleagues, so we appreciate your continued contribution
to this very important debate, and we look forward to this
continued dialog with all three of you as we try to get this
right for the sake of our National security and the safety of
Americans.
With that, the Subcommittee will keep the record open for 1
week for questions that members of the Committee might wish to
pose. With that, the Subcommittee will stand adjourned.
[Whereupon, at 4:32 p.m. the Committee was adjourned.]
[Submissions for the record follow.]
[GRAPHIC] [TIFF OMITTED] 55644.001
[GRAPHIC] [TIFF OMITTED] 55644.002
[GRAPHIC] [TIFF OMITTED] 55644.003
[GRAPHIC] [TIFF OMITTED] 55644.004
[GRAPHIC] [TIFF OMITTED] 55644.005
[GRAPHIC] [TIFF OMITTED] 55644.006
[GRAPHIC] [TIFF OMITTED] 55644.007
[GRAPHIC] [TIFF OMITTED] 55644.008
[GRAPHIC] [TIFF OMITTED] 55644.009
[GRAPHIC] [TIFF OMITTED] 55644.010
[GRAPHIC] [TIFF OMITTED] 55644.011
[GRAPHIC] [TIFF OMITTED] 55644.012
[GRAPHIC] [TIFF OMITTED] 55644.013
[GRAPHIC] [TIFF OMITTED] 55644.014
[GRAPHIC] [TIFF OMITTED] 55644.015
[GRAPHIC] [TIFF OMITTED] 55644.016
[GRAPHIC] [TIFF OMITTED] 55644.017
[GRAPHIC] [TIFF OMITTED] 55644.018
[GRAPHIC] [TIFF OMITTED] 55644.019
[GRAPHIC] [TIFF OMITTED] 55644.020
[GRAPHIC] [TIFF OMITTED] 55644.021
[GRAPHIC] [TIFF OMITTED] 55644.022
[GRAPHIC] [TIFF OMITTED] 55644.023
[GRAPHIC] [TIFF OMITTED] 55644.024
[GRAPHIC] [TIFF OMITTED] 55644.025
[GRAPHIC] [TIFF OMITTED] 55644.026
[GRAPHIC] [TIFF OMITTED] 55644.027
[GRAPHIC] [TIFF OMITTED] 55644.028
[GRAPHIC] [TIFF OMITTED] 55644.029
[GRAPHIC] [TIFF OMITTED] 55644.030
[GRAPHIC] [TIFF OMITTED] 55644.031
[GRAPHIC] [TIFF OMITTED] 55644.032
[GRAPHIC] [TIFF OMITTED] 55644.033
[GRAPHIC] [TIFF OMITTED] 55644.034
[GRAPHIC] [TIFF OMITTED] 55644.035
[GRAPHIC] [TIFF OMITTED] 55644.036
[GRAPHIC] [TIFF OMITTED] 55644.037
[GRAPHIC] [TIFF OMITTED] 55644.038
[GRAPHIC] [TIFF OMITTED] 55644.039
[GRAPHIC] [TIFF OMITTED] 55644.040
[GRAPHIC] [TIFF OMITTED] 55644.041
[GRAPHIC] [TIFF OMITTED] 55644.042
[GRAPHIC] [TIFF OMITTED] 55644.043
[GRAPHIC] [TIFF OMITTED] 55644.044
[GRAPHIC] [TIFF OMITTED] 55644.045
[GRAPHIC] [TIFF OMITTED] 55644.046
[GRAPHIC] [TIFF OMITTED] 55644.047
[GRAPHIC] [TIFF OMITTED] 55644.048
[GRAPHIC] [TIFF OMITTED] 55644.049
[GRAPHIC] [TIFF OMITTED] 55644.050
[GRAPHIC] [TIFF OMITTED] 55644.051
[GRAPHIC] [TIFF OMITTED] 55644.052
[GRAPHIC] [TIFF OMITTED] 55644.053
[GRAPHIC] [TIFF OMITTED] 55644.054
[GRAPHIC] [TIFF OMITTED] 55644.055
[GRAPHIC] [TIFF OMITTED] 55644.056
[GRAPHIC] [TIFF OMITTED] 55644.057
[GRAPHIC] [TIFF OMITTED] 55644.058
[GRAPHIC] [TIFF OMITTED] 55644.059
[GRAPHIC] [TIFF OMITTED] 55644.060
[GRAPHIC] [TIFF OMITTED] 55644.061
[GRAPHIC] [TIFF OMITTED] 55644.062
[GRAPHIC] [TIFF OMITTED] 55644.063
[GRAPHIC] [TIFF OMITTED] 55644.064
[GRAPHIC] [TIFF OMITTED] 55644.065
[GRAPHIC] [TIFF OMITTED] 55644.066
