[Senate Hearing 107-656]
[From the U.S. Government Publishing Office]
S. Hrg. 107-656
GERMS, TOXINS AND TERROR: THE NEW THREAT TO AMERICA
=======================================================================
HEARING
before the
SUBCOMMITTEE ON TECHNOLOGY, TERRORISM,
AND GOVERNMENT INFORMATION
of the
COMMITTEE ON THE JUDICIARY
UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
__________
NOVEMBER 6, 2001
__________
Serial No. J-107-46
__________
Printed for the use of the Committee on the Judiciary
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81-677 WASHINGTON : 2002
___________________________________________________________________________
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COMMITTEE ON THE JUDICIARY
PATRICK J. LEAHY, Vermont, Chairman
EDWARD M. KENNEDY, Massachusetts ORRIN G. HATCH, Utah
JOSEPH R. BIDEN, Jr., Delaware STROM THURMOND, South Carolina
HERBERT KOHL, Wisconsin CHARLES E. GRASSLEY, Iowa
DIANNE FEINSTEIN, California ARLEN SPECTER, Pennsylvania
RUSSELL D. FEINGOLD, Wisconsin JON KYL, Arizona
CHARLES E. SCHUMER, New York MIKE DeWINE, Ohio
RICHARD J. DURBIN, Illinois JEFF SESSIONS, Alabama
MARIA CANTWELL, Washington SAM BROWNBACK, Kansas
JOHN EDWARDS, North Carolina MITCH McCONNELL, Kentucky
Bruce A. Cohen, Majority Chief Counsel and Staff Director
Sharon Prost, Minority Chief Counsel
Makan Delrahim, Minority Staff Director
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Subcommittee on Technology, Terrorism, and Government Information
DIANNE FEINSTEIN, California, Chairwoman
JOSEPH R. BIDEN, Jr., Delaware JON KYL, Arizona
HERBERT KOHL, Wisconsin MIKE DeWINE, Ohio
MARIA CANTWELL, Washington JEFF SESSIONS, Alabama
JOHN EDWARDS, North Carolina MITCH McCONNELL, Kentucky
David Hantman, Majority Chief Counsel
Stephen Higgins, Minority Chief Counsel
C O N T E N T S
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STATEMENTS OF COMMITTEE MEMBERS
Page
Edwards, Hon. John, a U.S. Senator from the State of North
Carolina....................................................... 20
Feinstein, Hon. Dianne, a U.S. Senator from the State of
California..................................................... 1
Kyl, Hon. Jon, a U.S. Senator from the State of Arizona.......... 6
Leahy, Hon. Patrick J., a U.S. Senator from the State of Vermont. 50
McConnell, Hon. Mitch, a U.S. Senator from the State of Kentucky. 32
WITNESSES
Abrams, Hon. Steven, Mayor, Boca Raton, Florida.................. 14
Atlas, Ronald, President-elect, American Society for
Microbiology, Washington, D.C.................................. 33
Caruso, James T., Deputy Assistant Director, Counterterrorism
Division, Federal Bureau of Investigation, Washington, D.C..... 8
Drake, Michael V., M.D., Vice President for Health Affairs,
University of California and Steven P. Shearing Professor,
Department of Ophthalmology, University of California, San
Francisco School of Medicine, San Francisco, California........ 44
Parachini, John, Policy Analyst, RAND Washington Office,
Washington, D.C................................................ 52
Reynolds, Jim, Chief, Terrorism and Violent Crimes Section,
Criminal Division, Department of Justice, Washington, D.C...... 18
SUBMISSION FOR THE RECORD
Department of Health and Human Services, Claude Allen, Deputy
Secretary, Washington, D.C., statement......................... 71
GERMS, TOXINS AND TERROR: THE NEW THREAT TO AMERICA
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TUESDAY, NOVEMBER 6, 2001
Subcommittee on Technology,
Terrorism and Government Information,
Committee on the Judiciary,
Washington, D.C.
The Subcommittee met, pursuant to notice, at 10:07 a.m., in
Room SD-226, Dirksen Senate Office Building, Hon. Dianne
Feinstein, [Chairman of the Subcommittee] presiding.
Present: Senators Feinstein, Edwards, Kyl, and McConnell.
OPENING STATEMENT OF HON. DIANNE FEINSTEIN, A U.S. SENATOR FORM
THE STATE OF CALIFORNIA
Chairperson Feinstein. I would like to call this hearing
together and say good morning and welcome, all of you. This is
the Judiciary Subcommittee on Technology, Terrorism and
Government Information.
A little over two months ago Robert Stevens, a photo editor
at American Media Incorporated in Boca Raton, Florida, was
diagnosed with inhalation anthrax. He died two days later. The
event began a second wave of terrorist attacks across our
country. In the past month an unknown number of deadly anthrax
packages have coursed through our domestic mail delivery
system. So far, 17 individuals have confirmed anthrax
infections. Four of those have died from inhalation anthrax.
Beyond the individual infections, communities have
contended with the disruption of the mail, the overflow of
public health clinics, the closing of buildings, and the
dislocation of commerce. Our own offices in the Hart Senate
Building remain closed because of anthrax contamination.
Our nation has little experience with anthrax. In the past
century only 18 cases of inhaled anthrax have occurred, the
most recent in 1976. Nor is our country familiar with
bioterrorist attacks. The only major documented bioterror
attack against an American population in the past century
occurred when an Oregon cult contaminated local salad bars with
Salmonella, poisoning 750 people.
The new bioterror threat, though, is unlike any other
threat our nation has encountered. It is different because
attacks do not come with a visible bang but are only recognized
after the fact by doctors or nurses in emergency rooms.
Antibiotics, not tanks and antimissile systems, provide the
best defenses. So while we cannot stop bioterrorism, I believe
we can reduce the threat.
This hearing will assess our existing protections against
bioterror in light of the recent anthrax attacks. It will also
review the security and prevention measures the United States
government can institute to further deter terrorist attacks.
I believe that this Congress can and should take concrete
actions today to reduce the bioterror threat and I hope this
hearing will shed some light on how best to proceed. For
example, I believe that we should toughen federal laws
resulting in the possession of specimens of anthrax, smallpox
and other highly toxic biological agents. Amazingly, until the
passage of comprehensive terrorism legislation several weeks
ago, the law actually did not prohibit any ordinary citizen
from building his own personal cache of anthrax. Even with the
new law, individuals can possess dangerous pathogens with very
few restrictions. It is actually up to the prosecutor in a case
to show why the individual should not possess these deadly
pathogens.
So I do not think we can afford to treat these weapons of
mass destruction so causally. Last week I announced legislation
to tighten controls over the possession of 32 different
biological agents, all of them deadly, and I am working with a
bipartisan coalition of senators, including Senator Kennedy and
Senator Frist and I hope Senator Kyl on my right, on a
comprehensive bioterrorism package to eliminate these
loopholes. My proposal would make it illegal for individuals to
possess personal stockpiles of dangerous biological agents like
anthrax or ricin. I can think of no legitimate reason why
ordinary people on the street need to possess these pathogens,
whether they be anthrax, smallpox or the Ebola virus specimen.
Under the bill, only labs certified by the Secretary of
Health and Human Services would be able to possess these
substances and only if they have a legitimate research purpose.
Therefore, only somebody working for a lab, certified with a
legitimate research purpose would be able to possess these 32
toxins and pathogens. Current law does not require labs to
register their possession of these agents. Thus, nobody knows
how many labs actually have them.
The legislation would require any researchers handling
these dangerous biological materials to pass background checks.
School bus drivers must pass criminal background checks.
Drivers of hazardous waste vehicles need to pass criminal
background checks. School employees in some states must pass
background checks and so should researchers who handle these
most lethal of agents.
Legislation should also allow for civil and criminal
penalties to be imposed on individuals who handle these
dangerous agents in a manner that threatens the public health.
I propose these new restrictions because quite simply,
these microbes are too dangerous to be handled without adequate
security. In the wrong hands, as we have seen, they can be
converted into weapons of substantial destruction.
Even according to the calculations of some experts,
biological weapons are, pound for pound, potentially more
lethal even than thermonuclear weapons. The Office of
Technology Assessment calculated that 100 kilograms of anthrax
spread over Washington would kill from 1 to 3 million people
under the right conditions. In contrast, a 1-megaton nuclear
warhead would kill from 750,000 to 1.9 million people.
I am not going to go into any more of that because I think
it is extraordinarily depressing, to say the least, but one
thing is clear. We should toughen our laws and we should see
that whether they are thermonuclear weapons or these 32 toxins
and pathogens, only the most certified labs and the people
working for these labs who have been cleared to handle these
pathogens and toxins should have possession of them.
We need to explore how the federal government can encourage
private sector companies to develop technologies to scan and
detect these agents. We need to examine the commercial sale of
equipment--aerosol sprayers, for example--used to disperse and
aerosolize these agents. We need to beef up needed stockpiles
of vaccines and better educate public health personnel. As a
matter of fact, the testimony that we have had today indicates
that the weakest link in our chain are local and state public
health offices.
So we have many initiatives that are needed and they can
help save life.
Before turning to the ranking member I want just very
quickly to state that the first panel will contain government
witnesses, including Jim Reynolds, the chief of the Terrorism
and Violent Crime Section of the Department of Justice, and Mr.
J.T. Caruso, the department assistant director of the FBI.
Deputy Secretary Claude Allen intended to testify but I
understand he has suddenly been taken ill. Apparently this is
the first time he has missed a day of work in seven years so
we're very sorry that he is not here. But our second panel will
include John Parachini of RAND Corporation, Dr. Michael Drake,
vice president of health affairs of the University of
California, Ronald Atlas, the national president of the
American Society of Microbiology, and Senator McConnell has
asked to introduce him, and Steven Abrams, the mayor of Boca
Raton, Florida, where the first outbreak took place.
[The press release of Senator Feinstein and information
regarding legislation follows:]
SENATOR FEINSTEIN URGES BAN ON INDIVIDUAL POSSESSION OF ANTHRAX, OTHER
PATHOGENS AND STRICT NEW CERTIFICATION OF LABS
WASHINGTON, D.C.--Concerned that dangerous pathogens and toxins
capable of being used as biological terror weapons are too readily
available, U.S. Senator Dianne Feinstein (D-Calif.) today announced
legislation to ban individual possession of these hazardous agents and
establish strict new certification requirements for labs.
``With the spread of anthrax through the mail, our nation is facing
an unprecedented biological attack,'' Senator Feinstein said. ``Yet
amazingly, under current law, individuals can possess anthrax bacteria,
smallpox virus or other dangerous pathogens with very few restrictions.
Labs are not even required to report this information to Federal
authorities unless they plan to transfer or move the pathogens. We are
a nation at risk and strict new safeguards are needed.''
Feinstein provided details of her legislation at a hearing of the
Judiciary Subcommittee on Terrorism, Technology and Government
Information, which she chairs.
Under her proposed bill, labs seeking to possess and work with a
specific list of biological agents would be required to be certified by
the Secretary of Health and Human Services as a legitimate research
facility and they would be required to demonstrate that possession is
required for legitimate research purposes.
The lab must also show that it can safely and securely handle the
pathogens and toxins by:
demonstrating proper training and skills to handle
such agents;
possessing proper facilities to dispose of the agents;
implementing security safeguards at its facilities to
prevent criminal and terrorist access to such agents.
Also, any individual handling the materials within the lab must
pass a background check and be registered with the Health and Human
Services Department or the Center for Disease Control for the specific
research project (or projects) requiring their use of the agents. A lab
that permits restricted individuals to handle the agents is subject to
decertification and civil penalties up to $500,000. Supervisory
personnel at labs where such violations occur would be subject to civil
and criminal penalties (one year in jail, civil fine up to $250,000).
The antiterrorism bill signed into law last week by President Bush
prohibited individuals from possessing pathogens unless they can
demonstrate they are using it for research and/or other peaceful
purposes. It also barred possession by convicted felons, illegal aliens
or other similarly restricted individuals. However, Senator Feinstein's
proposed legislation would go further and ban any individual possession
outside a government certified lab. Violators would face five years in
prison.
The legislation would also require the Secretary of Health and
Human Services to review, and if necessary, revise the existing list of
dangerous biological agents and toxins in consultation with the
Secretary of Defense, the Attorney General, the Director of the Center
for Disease Control and other appropriate agencies.
The current CDC list of select biological pathogens and toxins
includes:
Viruses
Ebola virus
Smallpox
Marburg virus
Eastern equine encephalitis virus
Rift valley fever
Lassa fever virus
Equine morbillivirus
Crimean-Congo haemorrhagic
fever
Tick-borne encephalitis
South American haemorrhagic
fever
Venezuelan equine
encephalitis
Hantavirus pulmonary
Yellow fever
Bacteria
Anthrax
Clostridium botulinum
Franeissella tularensis
Burkholderia
Brucella abortus
Francisella tularensis
Yersinia pesos
Rickettssiae and fungi
Coxiella burnetti
Rickettsia prowazekii
Rickettsia ricketsii
Coccidioides immitis
Toxins
Abrin
Aflatoxins
Botulinum
Clostridium perfringens
epsilon
Conotoxins
Diacetoxyscirpenol
Ricin
Saxitoxin
Shigatoxin
Staphylococcal enterotoxins
Tetrodotoxin
T-2 toxin
Summary of Feinstein Bioterrorism Protection Legislation:
Individual Possession--Prohibits any individual from possessing a
dangerous biological agent like anthrax or small pox under any
circumstances. The penalty would be five years in jail.
Lab/Medical Possession--Requires prior certification for any lab or
other organization wishing to possess anthrax or other dangerous
biological agents.
A lab would only be allowed to possess these agents if:
1. The lab is first certified by the Secretary of HHS as a
legitimate research, health or other entity;
2. The lab is separately certified to possess these agents for
legitimate research, medical, or other legitimate, peaceful
purposes;
3. The lab agrees to submit to periodic site inspections;
4. The lab can demonstrate proper training and skills to handle
such agents;
5. The lab possesses the proper facilities to dispose of the
agents;
6. The lab implements security safeguards at its facilities to
prevent criminal and terrorist access to such agents;
7. Any individuals handling materials within the facility must
pass a background check and be registered with the CDC for the
specific research project (or projects) requiring their use of
the agents.
List of Restricted Biological Agents or Toxins--Requires the
Secretary of HHS to review, and if necessary, revise the existing list
of dangerous biological agents and toxins in consultation with the
Secretary of Defense, the Attorney General, the Director of the CDC,
and other appropriate agencies.
Transfer to Unregistered Facilities--The legislation would prohibit
the transfer of dangerous biological agents or toxins to uncertified
labs or to individuals, and subjects violators to civil or criminal
penalties (up to $500,000 and/or 1 year).
Unsafe handling--Individuals who handle biological agents or toxins
in a manner that endangers the public would also be subject to civil
and criminal penalties.
Current CDC List of Biological Pathogens and Toxins
----------------------------------------------------------------------------------------------------------------
Viruses Bacteria Rickettsiae and Fungi Toxins
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1. Crimean-Congo 1. Anthrax 1. Coxiella burnetti 1. Abrin
haemorrhagic fever
2. Eastern Equine 2. Brucella abortus, B. 2. Rickettsia prowazekii 2. Aflatoxins
Encephalitis Virus melitensis, B. suis
3. Ebola virus 3. Burkholderia 3. Rickettsia ricketsii 3. Botulinum toxins
(Pseudomonas) mallei
4. Equine Morbillivirus 4. Burkholderia 4. Coccidioides immitis 4. Clostridium perfringens
(Pseudomonas) pseudomallei (fungi) epsilon toxin
5. Lassa5. Clostridium botulinum 5. Conotoxins
6. Marburg virus 6. Francisella tularensis 6. Diacetoxyscirpenol
7. Rift valley fever 7. Yersinia pestis 7. Ricin
8. South American 8. Saxitoxin
haemorrhagic Fever
9. Tick-borne encephalitis 9. Shigatoxin
10. Smallpox (Variola Major 10. Staphylococcal
virus) enterotoxins
11. Venezuelan Equine 11. Tetrodotoxin
Encephalitis
12. Viruses causing 12. T-2 toxin
hantavirus pulmonary
13. Yellow Fever
----------------------------------------------------------------------------------------------------------------
I would now like to turn to Senator Kyl and I want to thank
you for your effort and help and leadership, Senator. And
welcome to this hearing.
STATEMENT OF HON. JON KYL, A U.S. SENATOR FROM THE STATE OF
ARIZONA
Senator Kyl. Thank you, Senator Feinstein, and thank you
for holding this hearing at a most propitious time. Preparing
for this, my staff went back through some of the transcripts
and files from previous hearings that the two of us have held
over the last seven and a half years on this Terrorism
Technology Subcommittee and it was interesting to track back.
Two and a half years ago we held a hearing and talked about the
threat of anthrax in the bioterrorism context, issued some
warnings at that time. We have done the same for some other
threats that face us and it is no solace to me that there is
now a reality to the threats that we were projecting back at
that time. But this hearing today will certainly help us
understand if there are areas in which we need to make
improvements with regard to the control and the production of
these kinds of agents, what they need to be and how we can be
useful in doing that.
I would also like, though, to throw out another possibility
here that I hope we can deal with in the future. The question,
of course, has been asked, what if there had been a wider
spreading of the anthrax that was mailed? And we have all
contemplated how much difficult a challenge that would have
been for our responders and how many more casualties
undoubtedly would have resulted.
There is an additional threat which I would like to simply
note this morning and perhaps ask our witnesses to relate to in
their response to our questions. It is suggested by, whether it
was inadvertent or advertent, the use of aircraft by the
terrorists on September 11. I do not know that they fully
appreciated the extent to which the ripple effect of the use of
aircraft would damage our economy and affect so many other
areas of our society that were seemingly unrelated to the
specific subject of the attacks.
But contemplate that in our society where we are so
interdependent on high technology, among other things, that we
have a few very critical nodes of information, of
vulnerability--let me put it that way--a few places in our
country where an attack can have a very significant ripple
effect on other aspects of our society, our government, our
economy. And if there were a biological or chemical terrorism
event directed at the people or the place of that critical part
of our infrastructure, the effect could be dramatic in our
entire society, in effect creating a domino effect, a downward
spiraling of our ability to handle crises.
So because our society has these kinds of vulnerabilities I
think it is important for us as a Committee and for the new
Homeland Defense director to examine those points of
vulnerability for all of the various kinds of threats. We have
focussed on cyber threats in the past but certainly an anthrax
threat to a very critical node in our society could have a
dramatic impact on us all.
And I also think that, in addition to the kind of nuclear
weapon that Senator Feinstein talked about, we need to look at
the need for protection against the radiological weapon, the
weapon that is made out of conventional explosive that has a
significant amount of highly radioactive material imbedded in
it in such a way that upon explosion it spreads that
radioactivity over a larger area. It is important for us to
think about protecting spent fuel deposits and other areas.
So while we are focussed here directly this morning on a
slightly more narrow aspect of the problem, I think we will
probably have to enlarge our inquiry into all of the areas in
which our society will need to be protected.
So again I would just ask the witnesses, if not today, to
at least think about how they could respond to the obvious
question, which is what about other threats? Are there laws
that need to be passed? Are there loopholes in the way that our
government deals with these things? Any suggestions you could
make to us for congressional action would be very much
appreciated because our goal obviously is to find out where the
problems are so that we can respond to that legislatively or
support the administration in its administrative or executive
actions with regard to these threats.
Again I thank Senator Feinstein for holding this hearing
and look forward to obviously cooperating with her as time goes
on to do our part in defeating the terrorists and fighting this
war on terrorism. Thank you.
[The press release of Senator Kyl follows:]
KYL TO SEEK ANSWERS ON BIOTERRORISM
feirrstein-kyl hearing will examine ways to safeguard biohazardous
materials
WASHINGTON, D.C.--U.S. Senator Jon Kyl (R-A7), Ranking Member of
the Judiciary Committee's Subcommittee on Technology, Terrorism, and
Government Information, today welcomed administration officials and
other bioterrorism experts before the subcommittee, saying the American
people need reassurance on the state of U.S. bioterror preparedness.
``Bioterrorism is not a novel subject for this subcommittee, as
we've heard repeated warnings from experts on the dangers of a
bioterror attack,'' said Kyl. ``As far back as 1998, for example, we
called for a more coordinated, integrated approach to the detection and
tracking of bioterror threats within the United States such as
anthrax--and ways to enhance our ability to manage and treat outbreaks.
``It is important that Congress examine how we can be better
prepared for future outbreaks, what the greatest dangers posed to
Americans are, and whether we are ready to respond to serious health
emergencies.''
Expected to testify before the subcommittee today are
representatives from the FBI, Jim Reynolds, Chief of Terrorism and
Violent Crimes Section of the Department of Justice, and Claude Allen,
Deputy Secretary, Department of Health and Human Services.
Additionally, the subcommittee is expected to hear from many experts on
bioterrorism from the private sector.
``We will have to live with the threat of bioterrorism for the
foreseeable future, and we need to give the administration all the
assistance it may require in securing our homeland from bioterror
attacks,'' said Kyl. ``I welcome the opportunity to explore ways to
keep biohazardous materials from those who mean Americans harm.
Chairperson Feinstein. Thanks very much, Senator Kyl.
We will begin with the first witness. Mr. James Caruso was
reassigned to the Intelligence Division at the FBI as the
bureau's chief of Russian counterintelligence in 1990. He
served in several assignments for the Intelligence Division--
from 1994 to 1997 was an assistant special agent in charge of
the New York Field Office, then reported to FBI headquarters as
the section chief of the Eurasian Division, National Security
Division.
He was promoted to special agent in charge of the National
Security Division, the Washington Field Office in February of
1999. In 2001 he was designated deputy assistant director of
the Counterterrorism Division at the FBI headquarters.
And before you begin, Mr. Caruso, I would like to
acknowledge here someone that we had asked to testify today but
she declined because she is a journalist. I have worked with
her in the Aspen Strategy Institute and so I am delighted that
Judith Miller of the New York Times, the author of the best-
selling book ``Germs,'' is in the audience. As a matter of
fact, I just noticed that it had gone to the top of the New
York Times Bestseller list this Sunday. So welcome, Judith. We
are delighted to have you here.
Go, Mr. Caruso.
STATEMENT OF JAMES T. CARUSO, DEPUTY ASSISTANT DIRECTOR,
COUNTERTERRORISM DIVISION, FEDERAL BUREAU OF INVESTIGATION,
WASHINGTON, D.C.
Mr. Caruso. Good morning, Madam Chairwoman and Senator Kyl.
Director Mueller was unable to attend and sends his regrets.
I appreciate the opportunity to appear before you today to
discuss law enforcement response to bioterrorism. The
bioterrorism threat has risen to a new unprecedented level. The
federal government, in partnership with state and local law
enforcement agencies, has over recent years taken the threat
concerning the intentional release of a biological agent
seriously. Although the federal government and state and local
responders undertook training and coordination exercises in
recent years to hone their response to weapons of mass
destruction like biological agents, none faced an actual
release of anthrax.
The intentional introduction of bacillus anthraces into the
infrastructure of American lives has resulted in significant
national alarm concerning our health and safety. Today I would
like to comment on the manner in which the law enforcement
community responds to a suspected act of terrorism involving
biological agents and thereby demonstrate the cooperation which
exists between the federal government and the many first
responders who provide guidance, assistance and expertise.
The law enforcement response to a potential bioterrorist
threat is different, depending on how the biological agent is
introduced--whether it is an overt release or a covert release.
Regardless of whether a biological release is overt or covert,
the primary mission of law enforcement and the public health
community is saving lives. May I repeat? When the potential for
a biological release exists, the primary mission of law
enforcement and the public health community is saving lives.
An overt use of a biological agent involves the announced
release of an agent, often with some type of articulated
threat. An example of this would be the receipt of a letter
containing a powder and a note indicating that the recipient
has been exposed to a biological agent, such as anthrax. This
type of situation would prompt an immediate law enforcement
response, to include local police, fire, and emergency medical
service personnel. Each FBI field office is staffed with a
weapons of mass destruction coordinator whose responsibilities
include liaison with first responders in the community.
Due to this established relationship with first responders,
the local FBI WMD coordinator would be notified and also
respond to the scene. The articulated threat involving a
biological agent and the authority given to the FBI by statute
and Presidential Decision Directives 39 and 62 direct the FBI
to investigate these matters. The response protocol would
involve security the crime scene and initiating the FBI's
interagency threat assessment process. The FBI's
Counterterrorism Division at FBI headquarters coordinates this
threat assessment process, which determines the credibility of
the threat received, the immediate concerns involving health
and safety of all responding personnel, and the requisite level
of response warranted by the federal government. These
directives are based upon the detailed information received
from the on-scene personnel and input from other federal
agencies with an interest in the particular incident.
In a biological event, representatives from the Centers
from Disease Control and Prevention, the Department of Health
and Human Services, the United States Department of
Agriculture, and the Food and Drug Administration are the key
agencies called upon in assessing the particular threat. Based
upon that assessment, a determination is made as to the level
of response necessary to adequately address the particular
threat, which could range from a full federal response if the
threat is deemed credible to collection of the material in an
effort to rule out the presence of any biological material if
the threat is deemed noncredible.
The method of collecting suspect material is established by
protocol set forth by the FBI's Hazardous Material Response
Unit. These protocols, recognized and follows by state and
local hazmat teams, are necessary to ensure that sufficient
evidentiary samples are collected, screened and overpacked
according to scientific safety guidelines for transportation to
appropriate testing facilities.
Over 85 state health laboratories perform testing on behalf
of the CDC and belong to a coordinated collection of facilities
known as the Laboratory Response Network. Once the testing has
been completed, the results of the analysis are then
disseminated to the exposed person or persons, local first
responders, and to the local public health department.
Additionally, results will be forwarded to the Centers for
Disease Control and Prevention in Atlanta, Georgia and all
other agencies involved in the assessment.
A covert release of a biological agent invokes a different
type of response, this time driven by the public health
community. By its nature, a covert introduction is not
accompanied by an articulated or known threat. The presence of
the disease is discovered through the presentation of unusual
signs and/or symptoms in individuals reporting to local
hospitals or physician clinics. In this situation there is
initially no crime scene for law enforcement personnel to
respond to. The criminal act may not be revealed until days
have elapsed following the agent identification and preliminary
results obtained from the epidemiological inquiry conducted by
the public health sectors.
Contrary to an overt act where the law enforcement
community makes the necessary notifications to the public
health, in a covert release notification to law enforcement is
made by the public health sector. The early notification of law
enforcement in this process encourages the sharing of
information between criminal and epidemiological investigators.
Once an indication of the criminal act utilizing a biological
agent is suspected, the FBI assumes primary authority in
conducting the criminal investigation while the public health
maintains responsibility for the health and welfare of the
citizens.
The initial response of first responders, the FBI, our
federal partners, and the professional health community to an
actual threat or one that is later determined not credible or a
hoax is indistinguishable. The response to an actual threat or
a hoax tolls significant costs. All participants from the
responders to the potential victims and their communities can
be significantly and adversely affected.
The first responders, the FBI, the victims and the
communities in which they live must treat each incident as a
real event until scientific analysis proves that the material
is not a biological agent. Both the responding entities and the
potentially exposed victims pay a heavy price when it appears a
biological agent is present. As a result, hoaxes suggesting a
biological agent is present in a package, letter or location
are particularly pernicious. Individuals perpetuating hoaxes
dealing with weapons of mass destruction must be held
accountable for their actions.
In 1999 the FBI testified before the House Energy and
Commerce Subcommittee on Oversight and Investigations,
discussing the need for improved federal statutes which address
the threatened use and possession of biological agents. During
this testimony it was reported that in 1998 the FBI opened 181
cases related to weapons of mass destruction events, of which
112 were biological in nature. The number of cases has
increased since then to 267 in 1999 and 257 in 2000. The vast
majority of these instances were hoaxes.
As the Committee will quickly note by my upcoming
testimony, the number of FBI cases relating to alleged
biological agents initiated since mid-September of this year
went off the charts. Prior to the events of September 11, 2001,
the number of cases initiated for the first eight and a half
months of 2001 was 100, of which 67 were biological. A large
percentage of these cases involved the threatened release of
anthrax, necessitating a law enforcement response. Here again
the vast majority of these instances were hoaxes.
The combined terrorist attacks on the World Trade Center
and the Pentagon, the subsequent publicity afforded to a
handful of anthrax letters, and the traffic death of four
persons have resulted in a dramatic increase in calls for help
from the public. And, as it should be, the law enforcement
communities and first responder communities--fire, police, and
emergency medical personnel--and the public health communities
have responded.
Since mid-September the FBI has responded to approximately
7,089 suspicious anthrax letters, 950 incidents involving other
WMD matters, such as bomb threats, and an estimated 29,331
telephone calls from the public about suspicious packages. The
vast majority of these responses were not actual incidents.
Resources made available by law enforcement in responding to
the alleged threats and the resources made available by the
public health laboratories in testing suspicious materials for
the presence of biological agents are strained and stretched to
capacity.
As part of a terrorism-related legislative package which
the president signed into law, Congress recently passed a
modification of Title 18, U.S.C. Section 175, which
criminalizes the possession of biological material except for
medical or clinical purposes or bona fide research. Prior to
this modification, the government had the burden of proof that
possession of a specific biological agent was for illegal
purposes or evil intent. This was a significant burden on the
law enforcement community to provide sufficient proof that a
biological agent was intended to be used as a weapon.
Congress's modification will be a significant benefit in
addressing the need to apprehend and prosecute those
individuals who are capable of and intent upon creating a
biological weapon to harm and terrorize the American people. It
will allow for early apprehension of the responsible party and
the prevention of any release of biological material.
Under the leadership of the Attorney General John Ashcroft
and FBI Director Mueller, we are prosecuting noncredible
threats, hoaxes, to the fullest extent of the law. In fact,
nearly a dozen investigations, complaints or indictments have
been issued by the United States Attorneys Offices throughout
the country for persons threatening the release of anthrax.
Utilizing the statutory guidelines which became effective
November 1, 2001, these individuals face a possible five-year
mandatory minimum prison sentence.
Attorney General Ashcroft and Director Mueller are sending
a clear and unambiguous signal across America. Hoaxes
concerning biological agents, hoaxes concerning weapons of mass
destruction, will be aggressively investigated by the FBI and
vigorously prosecuted by the Department of State. Thank you,
Madam Chairwoman.
[The prepared statement of Mr. Caruso follows:]
Statement of James T. Caruso, Deputy Assistant Director, Federal Bureau
of Investigation, Counterterrorism Division
Good morning Madame Chairwoman, Senator Kyl and members of the
Subcommittee. I appreciate the opportunity to appear before you today
to discuss the law enforcement response to Bioterrorism.
The Bioterrorism threat has risen to a new level. The Federal
Government, in partnership with State and local law enforcement
agencies, has over recent years taken the threat concerning the
intentional release of a biological agent seriously. However, until
recently, neither the Federal Government nor State and local responders
have been required to utilize their assets to coordinate a response to
an actual release of anthrax. The intentional introduction of bacillus
anthracis into the infrastructure of American lives has resulted in
significant alarm concerning our health and safety. Today, I would like
to comment on the manner in which the law enforcement community
responds to a suspected act of terrorism involving biological agents,
and reinforce the cooperative effort that is in place between the
Federal Government and the myriad of first responders who provide
guidance, assistance and expertise.
The response to a potential bioterrorist threat can be broken down
into two different scenarios: overt and covert releases. The
distinction between the two involves the manner in which the biological
threat agent is introduced into the community and the nature of the
response. Regardless of whether a biological release is overt or
covert, the primary mission of law enforcement and the public health
community is saving lives.
An overt scenario involves the announced release of an agent, often
with some type of articulated threat. An example of this would be the
receipt of a letter containing a powder and a note indicating that the
recipient has been exposed to anthrax. This type of situation would
prompt an immediate law enforcement response, to include local police,
fire and emergency medical service (EMS) personnel. Each FBI field
office is staffed with a Weapons of Mass Destruction (WMD) Coordinator
whose responsibilities include liaison with first responders in the
community. Due to this established relationship with first responders,
the local FBI WMD Coordinator would be notified and dispatched to the
scene. The articulated threat involving a biological agent and the
authority given to the FBI by statute and Presidential Decision
Directives 39 and 62, directs the FBI to investigate these matters. The
response protocol would involve securing the crime scene and initiating
the FBI's interagency threat assessment process.
The FBI's Counterterrorism Division at FBI Headquarters,
coordinates this threat assessment which determines the credibility of
the threat received, the immediate concerns involving health and safety
of the responding personnel, and the requisite level of response
warranted by the Federal Government. These directives are based upon
the detailed information received from the on-scene personnel and input
from the necessary Federal agencies with an interest in the particular
incident. In a biological event, representatives from Centers for
Disease Control and Prevention (CDC), Department of Health and Human
Services (DHHS), United States Department of Agriculture (USDA) and
Food and Drug Administration (FDA) are the key agencies called upon to
assist FBI personnel in assessing the particular threat. Based upon the
assessment, a determination is made as to the level of response
necessary to adequately address the particular threat, which could
range from a full Federal response if the threat is deemed credible, to
collection of the material in an effort to rule out the presence of any
biological material if the threat is deemed not credible.
The method of collecting suspect material is established by
protocols set forth by the FBI's Hazardous Material Response Unit
(HMRU). These protocols, recognized and followed by state and local
Hazmat teams, are necessary to nure that sufficient evidentiary samples
are collected, screened and over-packed according to scientific safety
guidelines for transportation to the appropriate testing facility. More
than 85 State Health Laboratories perform this analysis on behalf of
CDC and belong to a coordinated collection of facilities known as the
Laboratory Response Network (LRN). Once the testing has been completed,
results are provided to the FBI for dissemination in the appropriate
manner. The results of the analysis are then disseminated to the
exposed person or persons, local first responders and to the local
public health department. Additionally, results will be forwarded to
the Centers for Disease Control and Prevention (CDC) in Atlanta, GA.
A covert release of a biological agent invokes a different type of
response, driven by the public health community. By its nature, a
covert introduction is not accompanied by any articulated or known
threat. The presence of the disease is discovered through the
presentation of unusual signs and/or symptoms in individuals reporting
to local hospitals or physician clinics. In this situation, there is
initially no crime scene for law enforcement personnel to respond to.
The criminal act may not be revealed until days have elapsed, following
the agent identification and preliminary results obtained from the
epidemiological inquiry conducted by the public health sector. Contrary
to an overt act where law enforcement makes the necessary notification
to Public health, in a covert release, notification to law enforcement
is made by the Public health sector. The early notification of law
enforcement in this process encourages the sharing of information
between criminal and epidemiological investigators. Once an indication
of a criminal act utilizing a biological agent is suspected, the FBI
assumes primary authority in conducting the criminal investigation,
while Public Health maintains responsibility for the health and welfare
of the citizens. At the local level, involving te BI WMD Coordinator
and the State or local public health department, and at the national
level between FBI Headquarters and the CDC, effective coordination has
been accomplished to address the requisite roles and responsibilities
of each agency.
The response to an actual threat or one that is later determined to
be not credible, or a hoax, is indistinguishable. This includes
deployment of a Hazmat team, thorough examination of the potentially
contaminated area (in situations where a telephonic reporting is
received) and the disruption of the normal operations of the affected
entity. Additionally, the individuals potentially exposed to the WMD
may experience extreme anxiety/fear due to the reported release.
Potential victims may have to be decontaminated or transported to a
medical facility. The first responders must treat each incident as a
real event until scientific analysis proves that the material is not a
biological agent. To both the responding entities and the potentially
exposed victims, the presence of a powder threatening the presence of
anthrax is not a ``hoax,'' or something to be taken lightly. The
individuals perpetrating such an activity must be held accountable for
their actions.
In 1999, the FBI testified before the House Energy and Commerce
Subcommittee on Oversight and Investigations, discussing the need for
improved Federal statutes which address the threatened use and
possession of biological agents. During this testimony, it was reported
that in 1998, the FBI opened 181 cases related to WMD events, of which
112 were biological in nature. The number of cases has increased since
then, with 267 in 1999, and 257 in 2000 (threatened biological releases
accounted for 187 and 115 respectively).
Prior to the events of September 11, 2001 and the subsequent
release of anthrax along the East Coast, the number of cases initiated
for 2001 was 100, of which 67 were biological. A large percentage of
these cases involved the threatened release of anthrax,necssitating a
law enforcement response. The combined terrorist attacks on the World
Trade Center and Pentagon, the subsequent publicity afforded to a
handful anthrax threats, and the tragic death of four persons, have
resulted in a dramatic increase in calls for help from the public. The
law enforcement communities and first responder communities (fire,
police and emergency medical services) have responded.
Since mid-September, the FBI has responded to approximately 7,089
suspicious anthrax letters, 950 incidents involving other WMD matters
(bomb threats, etc.], and an estimated 29,331 telephonic calls from the
public about suspicious packages. Resources available to law
enforcement for responding to the alleged threats and public health
laboratories in testing suspicious material for the presence of
biological agents are strained and stretched to capacity.
As part of the USA PATRIOT ACT which the President signed into law
on October 26, 2001, Congress recently approved a modification to Title
18, USC, Section 175 which criminalizes the possession of certain
biological material except in instances which are reasonably justified
by a prophylactic, protective bona fide research or other peaceful
purpose. Prior to this modification, the government bore the burden of
proof that specific possession of a biological agent was for illegal
purposes or evil intent. This created a significant burden on the law
enforcement community to provide sufficient proof that the biological
agent was intended to be used as a weapon. The recently provided
modification of Title 18, USC, Section 175 will be of significant
benefit in addressing the need to apprehend and prosecute those
individuals who are capable of and intent upon creating a biological
weapon to harm and terrorize the American people. It will allow for
early apprehension of the responsible party and the prevention of any
release of the biological material.
Under the direction of AG Ashcroft and FBI Director Mueller, the
Federl goernment is now prosecuting non-credible threats, or hoaxes,
within the full extent of the law. In fact, 11 indictments or
complaints have been issued by United States Attorney's Offices
throughout the country, threatening the release of anthrax. Utilizing
the statutory guidelines which became effective November 1, 2001, these
individuals face a possible 5-year mandatory minimum incarceration.
As the FBI strives to meet new challenges, we will continue to
stress coordination with state and local law enforcement agencies and
emergency responders through Joint Terrorism Task Forces (JTTFs),
Regional Terrorism Task Forces (RTTFs) and WMD Coordinators.
This concludes my prepared remarks. I would like to respond to any
questions of the Subcommittee.
Chairperson Feinstein. Thank you very much, Mr. Caruso.
I neglected to ask everybody to please try to confine your
remarks to five minutes so that we can have some questions and
discussion. And I am going to change the order of witnesses
slightly because I think with what you said, Mr. Caruso, it
would be very important to have the mayor of Boca Raton come to
the table right now and if you could take your place at that
end, that is fine.
The mayor is Steven Abrams. He is from the city of Boca
Raton. He is past president and board member of the Palm Beach
County League of Cities. He has served as a member of the board
of directors of the Florida League of Cities. He was a member
of the Treasure Coast Regional Planning Council, was appointed
by the president of the Senate to the Florida Commission on
Local Government.
He is a practicing lawyer. He is a graduate of Harvard,
received his law degree from George Washington University, born
in Des Moines, Iowa and grew up in Philadelphia and found his
way to Boca Raton.
Mr. Mayor, we welcome you. As a former mayor, I would be
very interested in your comments on how you believe the
government reaction to your plight was, where there are
problems and how we might correct them.
STATEMENT OF HON. STEVEN ABRAMS, MAYOR, BOCA RATON, FLORIDA
Mayor Abrams. Thank you, Madam Chairman. Unfortunately,
Boca Raton was the first city, as you noted, in America to have
to deal with a bioterrorism incident. I am glad to say though
as mayor that we fully recovered, we are back to normal, the
quality of life that Boca Raton is known for, people are
enjoying, but I do want to thank the Subcommittee for the
opportunity to share our lessons with you.
As the president has said several times since September 11,
cities are the first line of defense against potential
terrorist threats. And I would add to that that city officials
are the first point of contact for residents who are seeking
reassurance and seeking information.
We do not need, as local officials, to know when the ground
troops are going into Afghanistan but we do need to be aware of
information affecting the health and safety of our residents.
And we also need to know as soon as possible about decisions
that affect city operations. I mentioned in the testimony that
I prepared, which I ask be included in the record, certain
examples, one of which was when the post offices in Boca Raton
were involved. Remember these were the first post offices in
the United States to be affected by anthrax, the trail leading
from the AMI building in Boca Raton. We at the city level had
been hearing rumors that the post offices were going to be shut
down, that people were going to be evacuated, as they had been
at the AMI building, and that was significant for us because
one of our post offices was not the typical stand-alone
building but was integrated into a low-rise office building
housing about 4,000 private sector employees.
Now the FBI and the CDC were very helpful in confirming
these secondhand reports but certainly a more proactive effort
can be undertaken in the future. And I am certainly not here to
point fingers at anyone because I have been working now with
the law enforcement and the public health professionals and
they are working around the clock to ensure our safety and we
are very grateful for their efforts.
In fact, I want to show my confidence in the public health
professionals. I was in, for example, the postal facility
speaking to the very worried workers and in the perimeter of
the AMI building talking to our police officers and our
firefighters who were securing the site and I have not been
tested for anthrax; I am not taking antibiotics because, as a
public official, I feel it is important for me to show
confidence in the assurances that are given by our public
health professionals.
But certainly steps though can be taken to improve the
lines of communication. I am suggesting several things. First
is that there be a point person or a single agency to take
responsibility for coordinating the investigation. This is
difficult. As has been pointed out, bioterrorism incidents, by
definition, have a criminal aspect to them and have a public
health aspect to them so there is a lot of responsibility
across the board. But to the extent that one agency or one
person can be the point person, that would be very useful.
Also, the affected city should be included fully in the
command that is established. There should be a central
information command for the dissemination of public information
so that it is coming from one source.
I guess I would say in closing--
Chairperson Feinstein. Did you set up a command post
immediately?
Mayor Abrams. Yes, Palm Beach County set up its emergency
operations center because health issues are not within the
jurisdiction of the city but within the jurisdiction of the
county and the state of Florida. So the county immediately set
up its emergency operations center but that was one agency.
I would say in closing, in illustrating this, that believe
it or not I now subscribe to the National Enquirer which, as
you know, is published by AMI. During the course of the
investigation they had felt at times that they were not quite
in the information loop so were developing their own sources
and their own back channels of information, which actually
proved quite reliable, but that is not the solution, obviously,
although I am sure my friend the CEO of AMI would tell you that
it is the solution, that everyone should subscribe to his
publications. But obviously it is not and we had to set up our
own back channels, as well.
The answer is to consider some of these suggestions that I
have made, that others have made. Mayor Guiliani has had the
same frustrations. He has indicated and has offered suggestions
and recommendations so that we can make the system work better
in the future for everyone. And I would be glad to answer any
questions that you or Senator Kyl might have.
[The prepared statement of Mayor Abrams follows:]
Statement of Hon. Steven L. Abrams, Mayor, City of Boca Raton, Florida
Thank you, Madam Chairman, Members of the Subcommittee. My name is
Steven Abrams, the Mayor of Boca Raton, Florida.
Unfortunately, Boca Raton was the first city in America to have to
deal with a bioterrorism incident. I appreciate this timely opportunity
to share the lessons that we learned to help other cities that are
facing this challenge now and that may face it in the future.
Those who attacked the American Media, Inc. building in Boca Raton
with anthrax could not have picked a safer city. Boca Raton has always
had an international reputation as a safe and secure city. In fact, we
are an even safer and more secure city in the aftermath of this
incident.
Our Fire-Rescue Department's hazardous materials team has won
international competitions. Our Police Department is outstanding. They
responded in exemplary fashion to the anthrax incident.
But we could not do it alone. I want to thank the federal, state,
and county agencies that assisted us. Our Governor, Jeb Bush, was there
for us. In addition, I want to thank Senator Nelson, who also came to
Boca Raton and offered the city his assistance.
Madam Chairman, the assistance that cities need is in establishing
and maintaining effective lines of communication with all of the
different agencies.
The President has stated on more than one occasion since September
11 that cities are the first line of defense against terrorist threats.
City officials are also the first point of contact for our
residents who are understandably worried about the potential health and
criminal threats posed by bioterrorism.
But reliable information was frequently lacking. In fact, I was
surprised to hear that even the Mayor of New York had the same
concerns. Anything that would affect the safety and security of the
people of the city I need to know, and I need to know it now.
The division of responsibilities among the agencies themselves also
proved to a problem early on. I hasten to add the caveat that all of us
were covering new ground here. But the Subcommittee has asked us to
illustrate the gaps for future planning purposes.
Our police chief was first notified by the F.B.I. that the AMI
building would be tested for anthrax on the Friday after the case was
revealed concerning Robert Stevens, the AMI employee who eventually
died. But then that Sunday, the Chairman of the Palm Beach County
Commission was the one who contacted the city on behalf of the county
health department (which to add to the confusion happens to be a state
agency) to advise that the anthrax was discovered in the building and
that the city would be involved in securing the site (and later
decontaminating the investigators). The responsibility had shifted
between the criminal and the public health sides of the investigation.
Then the following Tuesday night, I watched on television, by pure
chance, a national press conference being held in Boca Raton to
announce that the third person in America had been exposed to anthrax
and that the incident was now being handled as a criminal
investigation.
I rushed over to the hotel and met face to face in the lobby with
the Acting U.S. Attorney and the F.B.I.'s Special Agent in Charge to
let them know in plain terms the necessity for better communications
between their agencies and the city. To their credit, they have kept
the city much better informed about the case from their side of it.
We don't need to know when ground troops are going into
Afghanistan, but we do need to be aware of information that affects the
health and safety of our residents, as well as know about developments
that will have a bearing on city operations.
It behooves the agencies to do this, Senators. The local
governments understand that the Federal agencies are leading the
investigation. However, making cities an integral and timely part of
the information loop will go a long way toward helping us to reassure
the public that the utmost is being done by the agencies to protect our
constituents, as well as toward dispelling misinformation that might
hinder the investigation.
I will give you another illustration. When the anthrax trail led to
the two post office facilities in Boca Raton, the lack of close
coordination persisted.
Our city manager, police chief, and I spent an entire morning
trying to track down rumors that one or more of our post offices were
contaminated and going to be shut down. This was significant for us
because one of the postal facilities is not a stand-alone building, but
is integrated into a low-rise office building housing some 4,000
employees of several private companies. We did not know if they were
going to have to be evacuated or tested. Even if they were not going to
be evacuated, we did not know what their reactions would be. We needed
to determine what our response would be.
Remember, these were the very first post offices to be contaminated
in the United States, and so we were in uncharted waters.
The F.B.I. and Center for Disease Control were helpful in
responding to our telephone calls for confirmation of reports we were
hearing secondhand. But this is simply not adequate. Indeed, public
statements were being made by members of our Congressional delegation
that communication with local governments and residents was
insufficient.
Mayors are the ones on the front lines-literally. We are standing
next to the crime scene tape that is cordoning off the site. We are
surrounded by the camped-out national media. Because of this, local
officials can build up a level of trust and confidence with the media
and their viewers and readers. It would have been easy for me to join
in the chorus of criticism, but I refrained. I want to join hands, not
point fingers.
So, for instance, even though I went inside the perimeter of the
AMI building to speak with our police officers and firefighters and
into one of the decontaminated postal facilities to answer questions
from worried workers, I will not get tested for anthrax nor take
antibiotics. I believe it is important for me as an elected official to
show confidence in the assurances given by our public health officials.
But please help give me a full measure of confidence, Senators.
There are improvements that can be made to the system.
These are my recommendations:
Establish at the outset one agency--with one authoritative
point person--to take responsibility for coordinating the
investigation. This is a designation, or even a direct role,
that could be determined by the new Office of Homeland
Security. Admittedly, this is difficult to do in bioterrorism
investigations that have both criminal and public health
aspects, but it must be done.
Second, an affected city should be fully included in any joint
command.
Third, a central information command should be set up so that
all of the public information that is released by the various
agencies is coordinated and comes from one source.
Finally, keep in mind that communications issues do not end when
the television cameras leave. I have just written to the Postal Service
to remind them that the city wants to know if further testing will be
done at Boca Raton's postal facilities and to tell us when we can
expect irradiation equipment to be installed to guard against a
possible second wave.
The Environmental Protection Agency is now cleaning up the AMI site
and will also have to be reminded that the City of Boca Raton should
not have to read about their findings in the newspaper, that we need to
be ahead of the curve to be able to calmly explain the results to a
still-anxious public.
So these are examples of additional Federal agencies that have been
brought into the case as it has progressed that do not appear to be
under any central command.
In closing, believe it or not, I just began a subscription to The
National Enquirer, which is published by American Media, Inc., so I can
keep up to date. When AMI felt that they themselves were being left out
of the loop, they, as investigative writers, developed their own
sources of information, which proved very reliable. I would speak with
AMI officials and, lo and behold, the information they gave me would
turn out exactly as they had recited. Similarly, I also was able to
effectively develop my own back channels of information.
But obviously this should not be the solution. I urge the
Subcommittee to focus on the ``government information'' part of your
name. Bioterrorism is terrible enough without the problem being
compounded by the potential for a mistake or needless panic because
local governments were lacking some piece of critical information.
Please know that my comments are meant to be constructive. These
bioterrorist attacks are a completely novel situation for all of us,
and indeed we were the first case. Dealing with bioterrorism is by
definition a complex multi-jurisdictional effort. All of our law
enforcement and public health professionals are working around the
clock to protect our safety. We are grateful.
Thank you again, Madam Chairman and Members of the Subcommittee,
for the opportunity to be heard today.
Chairperson Feinstein. Thanks very much, Mr. Abrams.
We are joined by Senator Edwards. Welcome, Senator. If it
is agreeable with you we will hear the next witness and then if
you have some comments you might like to make--
Senator Edwards. That would be terrific. Thank you.
Chairperson Feinstein. Excellent.
Mr. Reynolds was appointed chief of the Terrorism and
Violent Crimes Section when the section was created in 1991. He
continues to serve in that position. He has been affiliated
with the Department of Justice since 1968, served there
consistently since 1973. In 1978 he was appointed deputy chief
of the Criminal Division's Special Litigation Section. From
1979 to 1990 he served as principal deputy chief of the
division's General Litigation and Legal Advice Section. That
section had responsibility for a wide variety of federal
criminal offenses, including international terrorism cases,
domestic violence crimes, property offenses, and most
regulatory violations. In 1990 he became acting chief of that
section.
Mr. Reynolds, welcome.
STATEMENT OF JAMES S. REYNOLDS, CHIEF, TERRORISM AND VIOLENT
CRIMES SECTION, CRIMINAL DIVISION, DEPARTMENT OF JUSTICE,
WASHINGTON, D.C.
Mr. Reynolds. Thank you, Madam Chair, Senator Kyl, Senator
Edwards. Let me just submit my prepared statement and limit my
comments to just a couple of points so that we can move on
quickly to questions.
Chairperson Feinstein. Excellent. We appreciate that.
Mr. Reynolds. I would note that as we interrelate with
public health providers, with our colleagues at HHS, and with
law enforcement there has been a growing consensus over the
last several years that the most severe threat that we face is
the bioterrorism threat.
In that context, I know we have testified before your
Committee, Senator Kyl, and let me reference the testimony of
Dr. Margaret Hamburg, who was an assistant secretary previously
at HHS. In speaking of bioterrorism events she indicated in her
words that they differ from any other of terrorism in their
potential to precipitate mass behavioral responses, civil
disorder, pandemonium.
The government has devoted a lot of funds, as well we
should, to preparing to respond to bioterrorism incidents but
as Dr. Hamburg said in her testimony in 1999 before a
congressional Committee, measures that will deter or prevent
bioterrorism will be far and away the most cost-effective means
of countering threats to public health and social order that
flow from bioterrorism events. The consequences of the current
anthrax releases underscored the imperative of prevention and
let me just make a couple of comments on what we have perceived
for some time to be that imperative.
Federal law, as Tim Caruso referenced, had been tied to the
weaponization or the nexus between the possession of a
biological substance and its use as a weapon. That has
fortunately been altered in the recently enacted October 26
terrorism bill and now under 18 U.S.C. 175, the possession of a
dangerous biological substance in an amount and of a type that
is not reasonably justifiable for a peaceful purpose now
becomes illegal. That will be a significant benefit to law
enforcement as we move forward with the effort of preventing
biological incidents.
The importance of that statute for prevention flows from
the need to be able to have the FBI intervene at the earliest
possible time when we become aware that an individual is in
possession without justification of a dangerous biological
substance. If we wait until it is weaponized we may well wait
too late.
Let me mention just one other issue and that is as we look
as to whether there is a need for any further legislation we,
of course, know that HHS has submitted legislation and we look
forward to working with them and with Congress on that
legislation.
As far as other legislation, certainly it leaps out that
there is an issue of hoaxes. There are, as Mr. Caruso
indicated, presently out of control. They utilize scarce law
enforcement and public health resources. But well beyond that,
they exact a very substantial psychological toll on people who
are placed in a position of believing that their life or their
health is seriously threatened and they are left to wait for
laboratory results, which are necessary, before they can be
relieved of that concern. Often those results take two, three,
four days to get.
So under the imperative of prevention I think that we
should add as legislation is considered the imperative of
preventing hoaxes, people making statements knowing that their
statements have no basis in fact, leading then to the devotion
of a tremendous amount of public health and law enforcement
resources and to exacting a very substantial toll on members of
the public. Thank you.
[The prepared statement of Mr. Reynolds follows:]
Statement of James S. Reynolds, Chief, Terrorism and Violent Crimes
Section, Criminal Division, Department of Justice
Madam Chair and Members of the Subcommittee, thank you for the
opportunity to appear before you today. I am James S. Reynolds, Chief
of the Terrorism and Violent Crime Section of the Criminal Division,
United States Department of Justice. I appreciate the opportunity to
appear before you today to discuss the existing federal statutes
relating to dangerous biological agents and toxins.
In recent years a growing consensus has emerged among law
enforcement officials involved with counterterrorism that the most
serious form of terrorist threat confronting the United States relates
to the potential use of a biological weapon. This view is shared by
numerous academics and health care professionals, and is reinforced by
the pervasive consequences currently being confronted by our nation as
a result of the recent criminal dissemination of anthrax.
For example, Dr. D.A. Henderson, who has been appointed the
Director of the Office of Public Health Preparedness in the Department
of Health and Human Services, and who was formerly Director of the
Johns Hopkins Center for Civilian Biodefense Studies, advised a Senate
subcommittee that ``of the weapons of mass destruction, the biological
ones are the most greatly feared but the country is least well prepared
to deal with them.'' Subcommittee on Labor, Health and Human Services,
and Education of the Senate Committee on Appropriations, Hearing on
Bioterrorism (March 16, 1999).
Similarly, Dr. Margaret A. Hamburg, former Assistant Secretary for
Planning and Evaluation of the Department of Health and Human Services
advised a House subcommittee that ``a bioterrorist event is different
from all other forms of terrorism in its potential to precipitate mass
behavior responses such as panic, civil disorder and pandemonium.''
Subcommittee on Public Health of the House Committee on Health,
Education, Labor and Pensions (March 25, 1999).
In recent years, the Department of Justice has noted that there is
increasing telligence of interest by terrorists in the use of
biological weapons both in the United States and abroad. Five-Year
Interagency Counter-Terrorism and Technology Crime Plan submitted by
the Attorney General to Congress on December 31, 1998. This growing
interest in biological agents and their potential for use as weapons is
reflected in the significant increase in the number of cases the FBI
has encountered over the past several years involving biological agents
and toxins, including hoaxes and threats involving such materials. Most
recently, the United States and its citizens have been the subject of
anthrax disseminations which have resulted in deaths and illness, and
the interruption of governmental processes.
As a government, we are expending vast sums to prepare for the
eventuality of an attack involving weapons of mass destruction. While
those efforts are critically needed, the most effective way to counter
a biological weapons attack is by preventing it. As Dr. Hamburg noted
in her March 25, 1999, congressional testimony, ``measures that will
deter or prevent bioterrorism will be far and away the most cost
effective means to counter such threats to public health and social
order.'' The consequences of the current anthrax incidents serve to
underscore the importance of prevention.
To facilitate that paramount objective, improvements were recently
made to existing federal criminal statutes. Prior to the amendments of
October 26, 2001 (the USA PATRIOT Act, Pub. L. 107-56), the key federal
statutes pertinent to bioterrorism have been 18 U.S.C. 175 and 2332a.
Section 175 of Title 18, U.S. Code, makes it a crime to knowingly
possess, or to threaten, attempt, or conspire to possess, any
biological agent, toxin, or delivery system for use as a weapon.
Section 2332a of Title 18, U.S. Code, currently makes it a crime to
use, or to threaten, attempt, or conspire to use, a weapon of mass
destruction which involves a disease organism.
While these statutes have been of value to law enforcement, to
require a close nexus between the possession of a biological agent and
its use as a weapon. By the time a biological weapon or device has been
created or is under development, it may be too late to undertake action
to prevent a biological weapons attack. Law enforcement needs a means
to intervene earlier in the chain of events that could lead to the
potentially catastrophic use of a biological weapon.
On October 26, 2001, 18 USC 175 was amended. Among the changes was
the insertion of a provision that makes the knowing possession of any
biological agent or toxin a crime if the agent is of a type or in a
quantity that, under the circumstances, is not reasonably justified by
a ``prophylactic, protective, bona fide research, or other peaceful
purpose.'' Additionally, the amendment creates a category of restricted
persons who are barred from possessing any biological agent that has
been designated under the Code of Federal Regulations as a ``select
agent.'' These are biological agents and toxins that have the potential
to pose a severe threat to the public health and safety. The term
``restricted person'' includes individuals under indictment for a
felony or who have been convicted of a felony, unlawful users of
controlled substances, illegal aliens, and persons who have been
adjudicated as a mental defective or who have been committed to a
mental institution. Knowing possession of a select agent by any
restricted person constitutes a felony.
These recent amendments to the federal biological terrorism
statutes will be of assistance to federal law enforcement in pursuing
action designed to prevent potentially tragic bioterrorism acts. For
example, if probable cause is developed that a person possesses a
biological agent and such possession is not reasonably related to a
peaceful purpose, an arrest warrant can be sought for the purpose of
arresting the individual before the biological agent is used in a
manner that endangers the public. Previously, action could not be taken
against the possessor of the agent absent proof that he possessed the
agent for use as a weapon. Similarly, if probable cause is developed
that a restricted person, such as a felon, is in possession of a select
agent (i.e., any one of a group of particularly deadly biological
agents), law enforcement can take action against that individual
without delay.
In light of the recent anthrax incidents, there is a need for
additional changes in federal law relating to biological terrorism. For
example, and as Secretary Allen notes in his testimony, the Department
of Health and Human Services recently submitted a package of such
changes to Congress for its consideration.
Another area of legislation that merits consideration relates to
the creation of a statute that specifically addresses hoaxes which
involve purported biological substances. Such a statute could also
address hoaxes involving chemical, nuclear, and radiological
substances. Persons who convey information, knowing it to be false,
indicating the existence of a hazard involving a biological substance,
cause a public safety response that drains governmental resources and
diminishes the capability to respond to actual hazardous material
incidents. Moreover, such hoaxes inconvenience the public and often
exact a significant psychological toll from victimized members of the
public who are placed in the position of fearing that their health or
life is endangered.
Madam Chair, that concludes my prepared remarks. I will be happy to
respond to any questions that you or other Members of the Subcommittee
may have at this time.
Chairperson Feinstein. Thank you very much.
Senator Edwards, would you like to make a quick statement
before we proceed to questions?
STATEMENT OF HON. JOHN EDWARDS, A U.S. SENATOR FROM THE STATE
OF NORTH CAROLINA
Senator Edwards. Just very briefly, Madam Chairwoman.
Let me first thank you for having this hearing on such an
important issue and before Senator Kyl leaves, thank you and
Senator Kyl for all the work you have done on this issue for so
many years. The both of you have been ahead of the curve on
this and you have shown real leadership and we thank you for
that.
The purpose of this hearing and the subject matter of this
hearing is very important and I want to ask questions about
that later and comment on it. Before I get to that I want to
update my colleagues on the work we have been doing on the
issue of preparedness. I know Senator Feinstein made a comment
about that earlier.
Several weeks ago Senator Hagel and I introduced
legislation before the anthrax attacks began dealing with the
issue of preparedness for a possible biological attack. Both of
us believe very strongly that there were some critical things
that need to be done and it basically fell in three different
categories: first, making sure that the people on the front
lines were ready to respond to a biological attack if one
occurred, which meant getting money out of Washington to the
local and state authorities, the people who, in fact, would
have to respond--local health care providers, local emergency
rooms, members of the public health system--and making sure
that all the folks who would be responsible for first
identifying that a biological attack had occurred and
responding to it were prepared.
Secondly, making sure that we had adequate stockpiles of
vaccine and antibiotics, which we all now know, the American
people now know we do not presently have.
And third, making sure both our crop supply and our food
supply were better protected. Those were the three components
of our legislation.
We have been working with Senators Kennedy and Frist over
the past several weeks. We are very close to having an
agreement to introduce a comprehensive piece of bipartisan
legislation. I expect that legislation to be introduced
sometime in the next day or so. It will incorporate the three
major components of the work that Senator Hagel and I have done
and I think will go a long way toward getting this country
adequately prepared to respond to a serious biological attack.
I also want to say on the subject matter of this particular
hearing, and I am interested in the comments of the witnesses,
that we obviously need to be prepared to deal with this issue
of hoaxes and I think they need to be taken seriously and
treated seriously from a criminal prosecution perspective. The
questions I have, which I will address later after my
colleagues have had a chance to ask questions, are number one,
is existing law adequate to prosecute this particular behavior?
And number two, if it is not, what does the law need to contain
substantively? And I am more specifically interested in any
comments that any of you would have about what the mens rea
requirement should be, the criminal intent requirement, in any
kind of statute that we might enact.
So Madam Chairwoman, thank you for letting me make those
comments and I have some questions when you and my colleagues
have finished.
Chairperson Feinstein. Good. Thank you very much, Senator.
I have just two questions in this round. The first is
really for Mr. Caruso.
I have been very surprised the FBI has not made more
progress and I would assume by now all labs have been checked.
I'm talking about the derivation of the anthrax, particularly
that that was in the Daschle letter, which is highly pure, is
coated with something, aerosolizes easily. It seems to me that
within this country there are limited places where that kind of
anthrax would be available and that you could have early on
established the DNA and made that contact.
Is it fair to say then that that anthrax did not come from
one of these major laboratories?
Mr. Caruso. Senator, the answer to that is we are still
searching for that answer. With close partnership with the CDC
and USAMRID and other institutions, we are learning more about
the various characteristics of anthrax and with that, we are
positioning ourselves to ask smarter questions and get better
answers.
Chairperson Feinstein. How many labs handle anthrax in it
United States?
Mr. Caruso. We do not know that at this time.
Chairperson Feinstein. You do not know that?
Mr. Caruso. No, we do not. We are pressing hard to
determine that.
Chairperson Feinstein. Could you possibly tell me why you
do not know that?
Mr. Caruso. The research capabilities of thousands of
researchers is something that we are just continuing to run
down. I know it is an unsatisfactory answer and unsatisfying to
us, as well.
Chairperson Feinstein. So is what you are saying that
anthrax is actually in the hands of thousands of researchers
all across this country?
Mr. Caruso. No. What I am saying is that it appears to us
that there are many, many people who have been educated in the
United States over the years that possess the capabilities, the
intellectual knowledge to be able to produce various kinds of
pathogens. The question then after that also is do they have
the kind of laboratory access and equipment to be able to
actually produce something that would be harmful. That is also
a question that we are pursuing.
Chairperson Feinstein. Have you nailed down the number of
labs that are capable of producing this quality anthrax?
Mr. Caruso. We do not know that at this time.
Chairperson Feinstein. So you do not know how many labs
produce it, how many labs produce this quality. What do you
know?
Mr. Caruso. If I may, we could submit to you for your
review a detailed answer with reference to that. Some of the
information that I could provide you at this time in a public
forum would not be necessarily beneficial to the investigation
and the kind of work that we are doing. We would look forward
to providing that to you in a different forum than this.
Chairperson Feinstein. Okay, I would be happy to set that
up for the Committee.
How many people do you have working on this at this time?
Mr. Caruso. For the past seven or eight weeks since the
attack we have about 4,000 special agents and about 3,000
individuals across the country and around the world that are
working on this, as well as in partnership with other foreign
governments and services.
Chairperson Feinstein. And I trust you do not want to
discuss what foreign partnerships you have at this time, or is
it possible for you to tell us that?
Mr. Caruso. I would prefer to do that in a different forum.
We have about 44 legal attaches around the world, each in a
different country, and all of those countries have been helpful
to us in this effort, ranging from traditional partners in
Europe all the way through the Middle East, where we do have
legal attaches, legal representation, as well as into Southeast
Asia.
Chairperson Feinstein. Have you made any judgments whether
this could have been produced in other countries and, if so,
where?
Mr. Caruso. We have not come to any final judgments.
Chairperson Feinstein. Okay. Can you summarize what seems
to be delaying the investigation? Is it the fact that it is so
diffuse, that there are so many sources of anthrax? This has
been a big puzzle to me. I would have thought this was an
investigation, that there was a limited amount of this quality
out there, that it would be fairly easy to determine the number
of sources, go directly to them, get lists of everybody that
has handled them, run it down and come up with some
conclusions.
Mr. Caruso. I just follow up on some of the comments you
made earlier in your opening statement to us that the kind of
background investigations that are required for people in other
walks of life are not necessarily required for individuals who
are doing the kind of research that could produce very deadly
pathogens and that, I think, is a really good example as to how
widespread and diffuse the knowledge is to produce this.
The second aspect of that is--
Chairperson Feinstein. So you are corroborating that, in
essence, that there are many people handling this stuff that
should not be.
Mr. Caruso. We think that there are many people that have
the potential, that have the knowledge to be able to produce
deadly biological agents. The question then is do they have the
actual facilities and laboratory to do it? That is an important
piece to that. But we are a rich and diverse country and people
from all over the world have flocked here for education and
training. There are many, many people that pass through the
ivory halls of our universities and colleges and have now left
the United States and some remain here. It is a very, very big
population and universe to look at.
Chairperson Feinstein. Thank you very much.
One quick question, Mayor Abrams. Mr. Mayor, I want to go
back to the command center and you seem to indicate that this
was a health problem, therefore in the country jurisdiction, I
guess, not in your city jurisdiction.
Do you have an emergency command center where if you have a
major event all relevant departments report forthwith and was
that activated?
Mayor Abrams. Yes. One of the features of living in South
Florida is that we do have very good emergency preparedness
plans that are obviously geared more toward natural disasters.
We just missed a hurricane last week.
Chairperson Feinstein. Right.
Mayor Abrams. So we have very sophisticated equipment. The
city of Boca Raton, even though we are 75,000 people, has our
own emergency operation center and can staff it fully with the
most up-to-date equipment, as well as Palm Beach County.
So yes, we have the capability and, in fact, as I said, the
county did activate its command center. But the problem did not
occur in terms of being able to establish that but when you
have so many different jurisdictions because we are just
discussing the public health side which yes, is county but
actually is controlled by the state of Florida the way it is
set up in Florida, but also then the law enforcement side--the
FBI, the U.S. Attorney's Office.
Then, after the incident occurs, we have other federal
agencies involved. Right now the AMI building is still being
cleaned up by the Environmental Protection Agency. We now, of
course, have the Postal Service involved. So there are a myriad
of agencies, both federal, state and local, that are involved
and they need to be not just physically brought together but
have one spokesperson and have one agency that is clearly held
accountable.
When this incident broke the city was first notified by the
FDA through our police department and that was fine. Then when
several days later it was determined that the AMI building was
going to be evacuated, the city was notified by--we received a
call from our county commissioner that this was occurring. The
responsibility had shifted somewhere along the line from the
law enforcement side to the public health side and while we
were able to scramble and mobilize our people, it would have
been much more helpful to us if there had been a central point
person.
Chairperson Feinstein. Appointed by?
Mayor Abrams. Well, maybe that is a good task for the
Office of Homeland Security. The responsibility is among types
of--
Chairperson Feinstein. So you are talking about a federal
person that would be in charge, as opposed to your just taking
the bull by the horns and saying--one of the things I found in
emergencies, just do it. Just say so-and-so is in charge and
they say, ``Who said?'' ``I said.'' Then if they do not like
it, they lump it but it is done.
Mayor Abrams. That is true and that is, in fact, what has
to happen, especially at the local level because, as we have
seen in other cities where we have had incidents, people look
to their mayor and you know that better than anyone, and so you
automatically become a point person. And maybe it is the mayor
of a city who is the point person but there has to be some, it
would seem to me, some sort of process and procedure in place
so that there is not that appointment by default by someone who
can step up to the forefront and have the information and have
the knowledge to impart to the people.
Chairperson Feinstein. Thank you very much.
Senator Kyl?
Senator Kyl. Thank you, Madam Chairman.
First let me ask some questions to you, Mr. Reynolds. And I
wish Mr. Allen were here because some of my questions are taken
from his testimony. We will perhaps talk to him later.
Is it your understanding that most of the regulations that
were promulgated in 1997 pursuant to the 1996 act related to
the shipment of these kinds of materials?
Mr. Reynolds. That is correct and I think it is an
important point to pick up on because I do not want to leave
the impression, Senator Feinstein, from the testimony here that
we have no idea where anthrax is. Anthrax is a select agent
under the transfer reg put in place in 1997. The shipment of
anthrax from one laboratory facility to another must be done
pursuant to the regulation. There must be a documentation of
that.
So we have and we are following very closely the shipments
of anthrax and identifying the laboratories that received or
shipped anthrax.
Additionally, it takes a laboratory of a certain level. The
microbiologists here can correct me if I am wrong but I believe
it is at least a level 3 to deal with anthrax. Again HHS CDC is
advising us concerning level 3, level 4 laboratories.
So there is a very systematic effort to try to identify
where anthrax is and I do not want to leave you with the
impression that somehow we do not have a way of trying to track
that down. It is not a perfect way.
Senator Kyl. But I gather there are a fair number. Can you
quantify in any general sense the number of places where
shipments have come from or gone to that might be of interest
considering their level of expertise?
Mr. Reynolds. That is part of the investigation that is
being pursued right now. We do have the transfer records from
CDC and it is being pursued. I would be premature to comment on
or to quantify the numbers.
Senator Kyl. Okay. Now regarding the 1997 regs, were those
limited by the legislation to transportation or were the other
aspects with regard to law enforcement clear enough? Or do we
need to go beyond the shipment and transfer in legislation that
we consider?
Mr. Reynolds. Well, my understanding of the HHS bill is
that it would require under a regulatory process that would--
Senator Kyl. This is the proposed HHS bill.
Mr. Reynolds. The proposed HHS bill. It would create a new
regulatory process, which would subsume the one from 1997 and
add to it and the added provisions would involve some degree of
requirement of registration--that may not be the right term but
identification of ones possession of certain of the select
agents.
Senator Kyl. So without speaking for Secretary Thompson,
would it be your understanding that the proposal that he has
offered would represent the administration's view as to the
additional authorities or requirements that would be necessary
in this area, possibly excepting new legislation regarding
hoaxes?
Mr. Reynolds. I think that is a point at which we will need
to come back at a policy level as to whether there are other
areas.
Senator Kyl. This gets right to Senator Edwards's question,
the same question I had, and that is we need from the
administration, from the FBI, from HHS, from the Justice
Department and anybody else any other authorities that you
think the administration should have, any other procedures that
we need to legislate, any other assistance, whether it be
financial or otherwise, that we need to provide. And I would
invite you at this time to take that back to the attorney
general and to the others in the administration and we will
communicate with Secretary Thompson, as well. But there will be
some cross-committee jurisdiction here. Part of his legislation
probably would go to a different Committee than ours but with
respect to the legal part of it, we would certainly consider
that. So we need to know as soon as possible what other
recommendations the administration would have to deal with
this.
Now let me get specifically to the area of hoaxes and
probably either Mr. Caruso or you could answer this. Do you
think we need some additional legislation making various kinds
of hoax actions criminal and/or increasing the penalties for
them?
Mr. Reynolds. Yes.
Senator Kyl. And if so, would you be willing to communicate
with us about how you would propose that to be written?
Mr. Reynolds. We would be happy to work with staff to
prepare drafts. We have had some communications with staff.
There are a variety of hoax statutes, none of which are
biological hoaxes but a number of hoax statutes in the federal
criminal code. They are written in numerous different ways.
They have different intent elements.
Senator Kyl. Could you maybe try then to go back and
conform those as best as possible with a set of recommendations
that we could then take to the full Judiciary Committee and
improve that area?
Mr. Reynolds. Yes.
Senator Kyl. Just two other quick questions here. I got the
impression from the last answer to Senator Feinstein's question
that not only is the number of people scientifically capable of
dealing with anthrax fairly large in number but the facilities
are relatively ubiquitous, as well, and that might even include
facilities capable of producing the kind of spores that we are
aware of in recent weeks. Is that generally true?
Mr. Reynolds. I would prefer, if you could, that you ask
that to one of the microbiologists who will testify in the next
panel. You will get a more authoritative answer.
Senator Kyl. And finally, with regard to my earlier
question about--well, it is two parts. One, radiological
material, that is probably not included within a definition of
bioterrorism materials but would it not be important to ensure
that as we are drafting these statutes, to include radiological
materials, as well as biological materials if they are not
covered in some other statute?
Mr. Reynolds. Yes, I think we should consider, for
instance, in a hoax statute covering not only biological but
chemical, nuclear and radiological. All of those areas or at
least all but the chemical aspect of those four ares that I
mentioned are currently covered in the weapons of mass
destruction statute, 18 U.S.C. 2332(a). However, it does not
have a hoax provision.
Senator Kyl. Okay. But also, not just with respect to
hoaxes but also the identification of people who handle the
material, how it is shipped. In other words, the same kind of
requirements that would pertain to something like anthrax
should also pertain to radiological material of a certain level
of danger or radioactivity; would you not agree?
Mr. Reynolds. Again I am not an expert in that area. There
is both the Department of Energy and the Nuclear Regulatory
Commission. My sense from looking at this when we worked on
biological legislation after testifying before you, Senator
Kyl, in I think April of 1998, we did look extensively at the
nuclear and radiological pattern.
My sense is it is a highly regulated industry. There are a
lot of restrictions and we would need to look at that.
Senator Kyl. We will add that as a question to ask various
people at the department and we will ask the question of
others, as well. Thank you.
Mayor, I do not have any questions of you but it was a
fascinating bit of testimony that you provided our Committee
and I thank you for being here, as well.
Mayor Abrams. Thank you, Senator.
Chairperson Feinstein. I have one follow-up question I want
to ask. I am really sorry Mr. Allen is not here because this
leaves me very confused.
It is my understanding that one exemption in current CDC
regulation concerns so-called CLIA labs or labs that meet
certain certification requirements set forth under the Clinical
Laboratory Improvement Amendment of 1988. These labs, I am
told, are not required to register with the CDC if they
transfer or receive anthrax or other biological agents or
toxins.
Does anybody here know how many labs are currently
certified as CLIA labs?
Mr. Reynolds. I have heard the number. It is a large
number. I would not want to venture the specific figure.
Chairperson Feinstein. Does anybody know how many of these
labs are working with select biological agents?
[No response.]
Chairperson Feinstein. Do these labs that work with select
biological agents submit any kind of registration to any
government agency indicating that they are working with these
biological products?
Mr. Caruso. According to federal regulation there are about
100 laboratories that have registered and I can get you some
additional information about that that are required by federal
law 42 CFR 76 to register. I can get you some additional
information on that.
Chairperson Feinstein. Right, because I would appreciate
it. I am also going to send you questions in writing to
everybody because the way it appears to me, members, and I hope
I am wrong, this is one more area of intense sloppiness where
there are all these entities functioning out there, handling
these materials, and no one knows who they are, at least no one
in the federal government knows. And as the delay goes on and
we are unable to really come to grips with this thing from a
law enforcement point of view, the more I suspect how wide the
field is. I hope I am wrong but I think this Committee is
entitled to know some of this information, so I would hope that
when you get these questions, gentlemen, that you will give it
your highest priority.
Chairperson Feinstein. Any other questions of this panel?
Senator Edwards. Yes.
Chairperson Feinstein. Go ahead.
Senator Edwards. Thank you.
Mr. Caruso, you know as well as all of us do, that the
American people are very concerned about where we are today
with respect to determining the origins of this anthrax and
where it came from. I just want to ask you some basic
questions.
As of now, as you sit here now, do you know where the
anthrax came from?
Mr. Caruso. We do not know at this time.
Senator Edwards. Secondly, the anthrax has been tested. The
anthrax that has been sent through the mail to Senator Daschle
and others, do you know how many people in this country have
access to that anthrax as you sit here today?
Mr. Caruso. No, I do not know that at this time.
Senator Edwards. It is my understanding that the Daschle
letter contained what is known as the Ames strain of anthrax.
First of all, have you identified every person in the country
who has access to the Ames strain of anthrax?
Mr. Caruso. I do not believe we have had the ability to do
that. My understanding is, and I will defer to the scientists
to give you a better answer, the Ames strain goes back nearly
50 years and there might be a whole variety of people over
time.
Senator Edwards. The bottom line is you do not know who has
it.
Mr. Caruso. No, we do not know. It is too diverse a
population at this time.
Senator Edwards. Have you made any effort to go to the
places that you are aware of that have the Ames strain to make
sure that they have it under control, their supply under
control?
Mr. Caruso. We have FBI agents out over the country talking
to people in laboratories, as well as the laboratories that we
know of and following up leads that we may be given to other
places in the country.
Senator Edwards. The bottom line is this. As of now you do
not now where the anthrax came from and you have not been able
to identify all the people who may have access to it. Is that
fair?
Mr. Caruso. That is correct.
Senator Edwards. Let me ask you a follow-up question to
that. If at some point in the future there were another attack
in some other part of the country using another biological
agent, given the time that it has taken to get to the place you
are now with respect to these anthrax attacks and obviously
tremendous amount of work left to be done to figure out what
happened and how to prevent it from happening again, are you
prepared to fight a two-front war?
In other words, if another attack occurs or a third attack
occurs, are we ready to investigate and respond to those
attacks?
Mr. Caruso. Senator, we have a tremendous amount of
individuals that are working this particular case and we would
apply other individuals to work on a second front. There is no
other alternative. The American people expect us to do that and
we will do that.
Senator Edwards. My question is are you ready to do that?
Mr. Caruso. We are ready to do that and I think the kind of
excruciating and painless experience that we all have suffered
through this and we have learned from this has solidified and
made seamless the kind of partnerships that we have with the
federal and other state and local agencies. This is a war that
we are all fighting and like in every war, there is a certain
amount of fog but we are learning and we have learned from it
and we have no choice.
Senator Edwards. Now my understanding is there are
literally millions of letters that have piled up yet to be
decontaminated. Can you tell me where we are in that process?
Because it seems to me there may be many letters out there,
anthrax-contaminated letters right now that we do not know
about yet.
Mr. Caruso. I will ask some other people to give you a
fuller answer to that and your answer is across the country. We
can provide you with fuller details but I will tell you that
with reference to the mail that was bound for Capitol Hill,
that mail, well over 100,000, 150,000 pieces, as I understand
it, has been placed in 280 55-gallon drums apiece. That is 280
times 55. They have been moved to a location away from here. We
are going through those. We have identified a location. We have
built a special facility to handle that or reconfigured an
existing facility to handle that.
What we have done now is we have moved those 280 55-gallon
drums filled with mail. We are opening up each one of the 288,
they have been sealed, and we have been swabbing those to see
which ones, if any, have anthrax, and that is how we are going
to prioritize going through that.
Senator Edwards. What about that--excuse me for
interrupting you but what about the non-Capitol Hill mail?
Mr. Caruso. I need to have some other individuals get back
to you to tell you precisely what we are doing in those other
areas. The Capitol Hill mail, there is a precise approach that
I am aware of right now. All across the country there are other
approaches and I can get you the information that talks about
those various approaches and how many.
Senator Edwards. Are there different approaches being used
around the country with respect to the mail?
Mr. Caruso. No, I do not want to tell you that there are
not and then I may find that there is a variation that is
particular to a particular locality that is needed there.
Senator Edwards. I do not know what that means. Are you
using different processes at different places in the country or
not?
Mr. Caruso. I said I was not sure if we were using the
exact same process across the country because various
localities may have a particular requirement that has a
variation that works for them and not some other place.
Senator Edwards. Is it true though that there are still
millions of letters yet to be decontaminated? Is that true or
not?
Mr. Caruso. I would suggest that you go to the U.S. Postal
Service and get their best estimate. That is their business,
mail handling. We work in partnership with them but that would
be your--
Senator Edwards. Is the decontamination process affecting
your ability to get to the information you need?
Mr. Caruso. We have a good partnership with the U.S. Postal
Service.
Senator Edwards. But that was not what I asked you. Is the
decontamination process and how long that is taking affecting
your ability to get to the information you need?
Mr. Caruso. It slows down our ability to conduct forensic
tests on certain items because we have to ensure that it is
safe for the people in our laboratories and the people handling
it, so there is some delay.
Senator Edwards. Madam Chairwoman, I have just one other
question if I could ask it very quickly.
Chairperson Feinstein. Go ahead.
Senator Edwards. This comment is for Mr. Reynolds, you or
Mr. Caruso, either one. This goes to the issue of hoaxes and
what other action we need to take.
It seems to me that there are prosecutions on-going under
existing law for these hoaxes and I am just interested in
finding out, and Senator Kyl made mention of this, specifically
what it is that existing law does not already cover, number
one, and number two, if we need additional legislation, are you
suggesting that there would be a specific kind of criminal
intent that would be required? And secondly, would you require
that there be some sort of effect, in other words, some
emergency response that was generated by the hoax in order for
it to be a crime under the new statute?
Mr. Reynolds. The details of the statute remain to be
worked out and we are very much willing and solicit an
opportunity to work with staffs up here.
The issue of what we are doing right now, in the bio area
there is no, as I said earlier, no hoax statute so what we are
using is other statutes, such as threat statutes, mailing
threatening communications, or threatening to use a weapon of
mass destruction. Threat law is somewhat different from the
hoax statutes. The threat law looks toward a projection by a
person that they are going to do an act in the future, whereas
hoax will often involve simply the conveyance of knowingly
false information, does not suggest that the perpetrator is
going to do anything but conveys false information.
We very much need a hoax statute to assist with these cases
so that we are not put in the position of using statutes that
really are not well designed, not well tailored for the use
that we put them to. Does not mean that we are not having some
success; we are. But there are cases that we simply cannot
bring based on the lack of a hoax statute.
As relates to your second issue about a mens rea, the two
basic points that we see to one of these statutes is that they
would only relate to a person who conveys information about a
weapon of mass destruction knowing that information to be
false, knowing that information to be false, and secondly, that
the conveyance of that be under circumstances where it is
reasonable to believe that people are going to take that
statement seriously.
Those are, as we would perceive it, the two core elements
of the statute. Others have suggested placing other terms into
the statute. We would hope not to encumber the statute with a
number of what I think we may be able to perceive to be
unnecessary additions that burden the prosecution, but the
knowing dissemination of false information and doing it under
circumstances where it is reasonable that it will be taken
seriously, core elements of the statute.
Senator Edwards. Thank you. I would like to discuss that
further with you at some later time.
Madam Chairwoman, thank you for your patience.
Chairperson Feinstein. Thanks very much.
I just have a couple of quick questions for you, Mr.
Reynolds. Is it possible to take a clinical specimen of anthrax
intended for diagnosis or reference purposes and culture it in
such a way that it can later be produced in a quantity and
quality viable for use as a biological weapon?
Mr. Reynolds. I wish I could answer that. We spent a couple
of days ago two hours in a conference call with the CDC
scientists asking questions just like the question that you
asked but I need to defer that type of question to HHS and to
the scientists.
Chairperson Feinstein. I will ask the next panel.
One other quick question. Current regulations exempt labs
from registering with the CDC any transfer of a clinical
specimen that is used for diagnostic verification or reference
purposes. Does this mean that the anthrax found in Florida, in
the Hart Senate Building and in New York and New Jersey, all of
which were sent to various labs for diagnostic testing, was not
registered with the CDC?
Mr. Reynolds. If I understood your question correctly, I
think the answer, and again I would suggest that the
authoritative answer comes from HHS, but I do not believe that
any of the samples of anthrax--the swabbings, the testings that
were done--could be sent to a clinical lab, one of those
accepted labs. I am sure I will be corrected by the next panel
if I am wrong, based on my understanding.
Chairperson Feinstein. I am not quite sure that is the
answer to my question. My question is whether the anthrax
samples were registered with the CDC or whether these
particular ones were exempt, which I suspect they were.
Mr. Reynolds. Whether the samples were registered? You are
talking in terms of the transfer regulations that HHS has--
Chairperson Feinstein. Yes, it exempts labs from
registering with the CDC any transfer of a clinical specimen if
that specimen is being used for diagnostic, for verification or
for reference purposes. So all of these specimens found in
Florida, the Hart Building, New York and New Jersey were sent
to various labs for diagnostic testing. The fact that they have
not come up with something would indicate to me that they were
not registered with the CDC; therefore presenting us with
another huge loophole.
Mr. Reynolds. These are specimens that are sent through law
enforcement channels tightly controlled by the FBI. They are,
my understanding is, exempt from the transfer regulations but
they are also highly, highly controlled. They are evidence and
they are tracked as evidence.
Chairperson Feinstein. I understand that but they came from
somewhere. Before they were used illegally they came from
somewhere.
Mr. Caruso. So they were either misplaced or stolen or
modified in some fashion from a registered laboratory.
Chairperson Feinstein. Correct.
Mr. Caruso. I will use Mr. Reynolds's statement and say I
may be corrected later but the best information we have is that
the anthrax that was found in those letters, we have not been
able to take and trace them to--we do not believe that they
were stolen or misplaced from a registered laboratory.
Chairperson Feinstein. Which is the loophole I am talking
about because there is a huge quantity out there that does not
have to be registered, I gather, right?
Mr. Caruso. The laboratories and other areas is an industry
or an effort that also needs to look at itself, as we all are
doing right now across the country and saying where can we
improve the systems that we have.
Chairperson Feinstein. Mr. Caruso, am I correct, is there
an amount out there that does not have to be registered, that
is just floating around in individual hands?
Mr. Caruso. I do not have an official position on that. I
just cannot answer the question.
Chairperson Feinstein. I was not asking for an official
position. I was just asking for your professional opinion based
on what you have found so far.
Mr. Caruso. We have insufficient information for me to make
a declarative statement about this or that. We have questions
that need to be answered at this time. It is still a work in
progress.
Chairperson Feinstein. Thank you very much, gentlemen. We
appreciate your testimony.
Oh, Mitch? Excuse me, Senator McConnell.
Senator McConnell. I am here principally for the second
panel so I am happy to move on to the second panel.
Chairperson Feinstein. Thank you very much. Appreciate it.
I would like to defer to you. We will now be introducing our
second panel. It is my understanding that you have a very
distinguished constituent that you would like to introduce.
STATEMENT OF HON. MITCH MCCONNELL, A U.S. SENATOR FROM THE
STATE OF KENTUCKY
Senator McConnell. Thank you, Madam Chairman. I
congratulate you on holding these hearings on probably the most
timely subject in America today and take particular pleasure in
being here as a member of the Subcommittee to introduce a
constituent of mine, Dr. Ron Atlas.
Dr. Atlas is here representing the American Society for
Microbiology where he serves as the organization's incoming
president and co-chair of its Task Force on Biological Weapons.
The American Society for Microbiology is the single largest
life science society, representing more than 40,000 scientists.
As we know, microbiologists are on the front lines in our
efforts to detect biological agents in the environment and
treat those who have been exposed to them.
I have had the pleasure of working with Dr. Atlas in his
capacity as the dean of the University of Louisville Graduate
School and the director of U. of L.'s Center for the Deterrence
of Biowarfare and Bioterrorism. With Dr. Atlas and U. of L.'s
assistance, my home town of Louisville is at the forefront of
communities developing plans to respond to biological attacks.
Through the course of this year I have worked with Dr.
Atlas and U. of L. to secure funds for the center's initiatives
in the fiscal 2002 Labor, Health and Human Services
appropriations bill. In recent weeks Dr. Atlas has shared his
expertise with the White House, the Centers for Disease Control
and Prevention and various news outlets and I am grateful he is
able to join us today and offer his insight to our panel and
thank him for all of the leadership he has demonstrated during
this trying time. We are very, very proud of him at home and
grateful that he is here today.
Chairperson Feinstein. Thank you very much for that
introduction, Senator McConnell.
Why don't you proceed, since you had that wonderful
introduction? Go ahead and then we will introduce the remaining
panelists.
STATEMENT OF RONALD ATLAS, PRESIDENT-ELECT, AMERICAN SOCIETY
FOR MICROBIOLOGY, WASHINGTON, D.C.
Mr. Atlas. Thank you, Senator McConnell, for that very kind
introduction and thank you, Senator Feinstein, for inviting me
to testify today on behalf of the American Society for
Microbiology and thank you, Senator Kyl, for your role in
helping us combat terrorism.
I would like to just summarize some of my comments and ask
that the full testimony be added to the record. What I would
like to say is that this misuse of microorganisms has shocked
the more than 42,000 members of the ASM. The criminal and
deliberate spread of anthrax is completely contrary to the ends
of science and the principles for which ASM stands.
To minimize the risks of bioterrorism, the ASM has
consistently advocated appropriate government oversight and
monitoring. ASM's view is that legislation and regulations can,
should and must ensure protection of public safety but that
they should do so without encumbering legitimate scientific and
medical research or the clinical and diagnostic medicine needed
for the detection and treatment of diseases.
In 1999 I testified before the House that the ASM strongly
supported the registration for possession of all facilities
that had select agents so that we very much support the
position that you have advocated, that registration is
necessary. In our view though, registration through appropriate
federal regulatory mechanisms is tantamount to certification
and those regulations can and should control who has access to
the agents and the biosafety and biosecurity measures that, in
fact, need to be in place.
Concerning who should be responsible for that oversight,
the ASM feels that this should be in the hands of the Centers
for Disease Control and Prevention. That is the organization
that understands public health, that has a relationship with
the scientific community and can best provide the necessary
oversight. We think that the CDC should have the resources that
they need and that they should periodically revise the list of
select agents so that we have those true biothreat agents at
the top of our list, that they should promulgate additional
regulatory measures that ensure biosafety and biosecurity, and
that they should notify the Department of Justice of any
concerns that they may have about who is, in fact, possessing
these agents.
We think the CDC has a long history of regulatory oversight
concerning biosafety and that their biosafety manual outlines
both biosafety and biosecurity measures that, in fact, should
be in place.
We need to recognize though that bioterrorists are not
going to follow the biosafety manual. They are not likely to
register and it really is only the biosecurity and shipping
aspects of those regulations that may help us identify where
agents have come from.
Regarding who should be entitled to work with select
agents, we support the concept of setting reasonable limits
upon persons who may possess those select agents. We fully
support the restrictions that preclude individuals who are
disqualified from purchasing firearms from possessing select
agents. We, though, recognize that some care needs to be
exercised when we extend this, for example, to cover aliens. We
support the provisions of the USA Patriot Act which restricted
possession for aliens from those countries that are designated
as supporting terrorism but we are concerned about an extension
of this to all aliens--to Canadians, to other allies who, in
fact, join us in our fight against infectious disease.
This is a global fight. Infectious disease occurs all over
the world. It is a national security threat when it occurs
naturally and we have to enlist the aid of people from around
the world and in that regard we have to ensure that we do not
take actions that will form roadblocks between us and the
international community in our effort to, in fact, combat
infectious disease.
In that regard we have some concern with the USA Patriot
Act concerning the fact that it did not provide any ability for
an exemption. If the secretary of HHS and the attorney general
feel that someone should work with pathogens that are on the
select agent list, even if they are from one of the countries
that supports terrorism, we think that the appropriate
government officials should have been able to propose such an
exemption, so that is a concern of ours.
With regard to criminal penalties, we think these really
have to be specific and that they can and should be enacted in
a way that does not turn all of us legitimate scientists into
potential criminals where we run away from doing the necessary
work of developing diagnostic and vaccines and pharmaceuticals
that combat infectious disease, including those that threaten
us, like anthrax, in cases of bioterrorism. So we urge
extraordinary specificity in those very clear rules of the road
so that we know what we are doing and we follow those rules.
In conclusion, we feel that legislative acts to enhance
national security should add protection, that there are
criminal acts of bioterrorism that should be dealt with, and
that we need to act in ways that improve the health of
Americans and those beyond our shores with the development of
new pharmaceuticals and vaccines and diagnostic capabilities
that will protect the health of all Americans from both natural
diseases and those that may come from criminal bioterrorist
attacks.
In closing, I want to thank you, Senator Feinstein, for
holding this hearing and allowing me to address the
Subcommittee. This is a very important topic.
And finally, I would just like to express the view that
working together, the government and scientific and medical
communities can defeat the future threats of bioterrorism.
Thank you very much.
[The prepared statement of Mr. Atlas follows:]
Statement of Ronald M. Atlas, Ph.D., President-elect, American Society
of Microbiology, Co-Chair, ASM Task Force on Biological Weapons
Introduction
Thank you, Senator Feinstein and members of the Subcommittee, for
inviting me here today to discuss issues related to the regulation of
dangerous biological agents and toxins and to present the perspective
of the American Society for Microbiology (ASM). My name is Ronald M.
Atlas. I am Professor of Biology, Dean of the Graduate School at the
University of Louisville in Kentucky and co-director of the Center for
Deterrence of Biowarfare and Bioterrorism at the University of
Louisville, a major research institution with over 4,000 graduate
students.
I am appearing today as President-Elect of the American Society for
Microbiology, and co-chair of the ASM's Task Force on Biological
Weapons Control. The ASM is the largest single life science society in
the world. The ASM publishes 10 scientific journals, each of which
focuses on a distinct specialty within the microbiological sciences.
The ASM also annually publishes numerous scientific books and sponsors
many scientific meetings, conferences, and workshops on a broad range
of microbiological subjects. The ASM's membership consists of over
42,000 microbiologists, ranging in profession from laboratory
clinicians to research scientists and Nobel Prize laureates. A common
appreciation of science and a commitment to scientific integrity unites
this large and diverse scientific community.
The recent misuse of microorganisms has shocked the academic and
scientific communities. The deliberate and criminal spread of anthrax
is beyond comprehension for civilized people. It is completely contrary
to the ends of science. I hope our testimony today will be helpful to
the fashioning of legislation that will substantially diminish the
threat of bioterrorism, advance our nation's ability to respond to
bioterrorism, and encourage aggressive research against the global
problem of infectious diseases.
Interest of ASM in Bioterrorism Legislation
The ASM's mission is to advance the microbiological sciences to
gain a better understanding of basic life processes and to promote the
application of this knowledge for improved health, economic and
environmental well being. Our members recognize a duty to propagate a
true understanding of science. Scientists have an obligation to work
for proper and beneficent application of scientific discoveries. The
ASM and its members are committed to preventing misuse of microbiology
contrary to the welfare of humankind.
The ASM has a long and distinguished history of bringing
scientific, educational, and technical expertise to bear on issues
surrounding biological weapons. Over the past 15 years, the ASM has
worked with the Department of Health and Human Services (DHHS), the
Centers for Disease Control and Prevention (CDC), the National
Institutes of Health, the Department of Defense U.S. Army Medical
Research in Infectious Disease Command (USAMRID), the Department of
Agriculture (USDA), and Congress. The ASM supports legislation and
regulations that are based upon the essential principle of ensuring
protection of public safety without encumbering legitimate scientific
and medical research or clinical and diagnostic medicine for the
diagnosis and treatment of infectious diseases.
The ASM premises its review of legislative and regulatory
approaches on the need to pursue two goals with equal vigor and
commitment. We must do everything possible to prevent bioterrorism or
endangerment of the public welfare and, at the same time, we must
continue to work with endless energy to eradicate the scourge of
infectious diseases throughout the United States and the world.
As unfathomable as it is to the civilized mind, criminal attacks
are occurring in the form of bioterrorism. Most certainly, therefore,
the government, academic, and scientific communities are duty bound to
take every reasonable precaution to minimize any risk of misuse of
microorganisms for terrorism. The ASM unequivocally supports the urgent
development of responsible safeguards against the dissemination of
biological agents for misuse rather than for peaceful scientific
purposes.
Even as we strive to prevent bioterrorism, however, we must
recognize that legislation and regulation cannot provide absolute
assurance that additional acts of bioterrorism will not occur. As
important as our duty to attempt to prevent bioterrorism is, it is
equally important to pursue aggressive research and public health
improvements aimed at developing the most effective possible responses
to acts of biological terror.
Those of us in the legislative, regulatory, academic, and
scientific communities who must confront the prevention of bioterrorism
face a dilemma. Implementation of restrictive controls to impede access
to biological agents is inherently difficult and potentially could also
deter the critical research and diagnostic activities to combat
terrorism. Much of the material and equipment is in widespread use and
commercially and internationally available; dangerous pathogens are
naturally occurring; and, the research and technology knowledge base
relevant to biological weapons is publicly available. This means that
policy measures intended to limit access and use of dangerous
biological agents may adversely affect legitimate research and clinical
diagnostic testing. At the same time, we know that research and public
health responses to terrorism are critical components of the public
policy response to the threat that exists. All of us, therefore, must
strive for the proper balance between safeguards that prevent
bioterrorists from gaining access to select agents while not burdening
important research or clinical diagnostic testing.
While we must deal with bioterrorism, we cannot lose sight of the
fact that infectious diseases daily end the lives of thousands of
Americans and tens of thousands around the world. Infectious diseases
continue to be the third leading cause of death in the United States.
Extreme control measures to prevent bioterrorism, instead of enhancing
global security, could prove detrimental to that goal if scientists can
no longer obtain authenticated cultures. We must remember that natural
infectious diseases are a greater threat than bioterrorism. Infectious
diseases remain the major cause of death in the world, responsible for
17 million deaths each year. Microbiologists and other researchers
depend upon obtaining authenticated reference cultures as they work to
reduce the incidence of and deaths due to infectious diseases.
Because the prevention and treatment of infectious diseases is
critical to our population, we must minimize any adverse impact upon
vital clinical and diagnostic research related to infectious diseases.
The ASM believes that an essential part of obtaining the proper balance
is cooperation and communication between and among government,
academia, and scientific communities. The ASM is committed to a frank,
open, and ongoing dialogue, and we welcome the opportunity presented by
this Subcommittee and other members of Congress to work together to
achieve the right balance between research, public health and law
enforcement responses to the threat of bioterrorism. The ASM is
committed to recommending approaches for additional policies that
appropriately balance the crucial war on terrorism with vital research
that is needed to counter terrorism and eradicate disease.
Resources and Funding for Biosecurity
We continue to emphasize, that the Congress and the Administration
must recognize that such an expansion of existing regulations requires
additional financial and other resources for the CDC. The CDC must be
funded properly if it is to carry out its important functions. Further,
Congress must fund adequate prevention, control, and countermeasure
programs on a national, regional, state, and local basis. We know,
Senator Feinstein, that you and members of this Subcommittee and other
members of Congress are committed to research and to development of
countermeasure programs, and we welcome your understanding that such
measures are very, very important.
Existing Biosafety Legislation
While we recognize that much remains to be done, particularly in
light of the recent shocking bioweapon attack on U.S. citizens, we
should not overlook that progress has been made in developing
safeguards against bioterrorism without unduly inhibiting research or
clinical diagnostic testing. The 1989 Biological Weapons Act authorized
the government to obtain a warrant to seize any biological agent,
toxin, or delivery system the possession of which, under the
circumstances, has no apparent justification for prophylactic,
protective, or other peaceful purposes. The ASM worked with Congress to
ensure that this legislation did not restrict legitimate research and
the Senate report accompanying the bill stated that the bill would not
interfere with such activities. The 1989 statute also authorized
federal officials to intervene rapidly through an injunction or through
a seizure made without a warrant based on probable cause. The right to
intervene rapidly when there is probable cause to believe that
possession of biological agents or toxins is not justified for peaceful
purposes adds to the legal weapons against terrorism while protecting
legitimate scientific endeavors.
The Antiterrorism and Effective Death Penalty Act of 1996 broadened
penalties for development of biological weapons and illegitimate uses
of microorganisms to spread disease. The ASM testified before the 104th
Congress regarding the transportation of select agents and supported
passage of Section 511(d) of the Act. Like the 1989 Biological Weapons
Act, the Antiterrorism Act of 1996 protects dual public interests of
safety and free and open scientific research through promulgation of
rules implementing a program of registration of facilities engaging in
the transfer of select agents.
The 1996 Antiterrorism Act expanded CDC's responsibilities and the
regulatory structure for transporting dangerous biological agents. The
Act added the responsibility to ``prevent access to dangerous
biological agents for use in domestic and international terrorism or
for any other criminal purpose.'' It directs the Secretary of HHS to
maintain a list of biological agents that have ``the potential to pose
a severe threat to public health and safety.'' The Secretary also must
establish and enforce procedures for shipping such agents safely to
ensure that laboratory facilities can appropriately handle, contain and
dispose of them and must provide safeguards against access to them for
illegitimate uses. Registration may be denied if there is ``evidence
that the facility has or intends to use covered agents in a manner
harmful to the health of humans.'' The regulations authorize
inspections of facilities, for cause or at random, to ensure
compliance. Shipping institutions or individuals that wish to ship a
select agent must check that the receiving facility is registered and
must file a notification of the shipment with the registering facility.
The recipient must acknowledge receipt of the shipment.
Importantly, the Antiterrorism Act of 1996 provides for ``appropriate
availability of biological agents for research, education and other
legitimate uses.'' The ASM worked with the CDC to develop regulations
that balance the needs for legitimate research and diagnostic testing
with protection against the inappropriate acquisition of biothreat
agents. The ASM also assisted in the development of a list of select
agents that focused on the most dangerous with the highest potential
for use as a biological weapon.
The final regulation exempts CLIA certified clinical laboratories
if the agent is part of diagnostic, reference, verification, or
proficiency testing. Isolates of covered agents from clinical specimens
are to be disposed of after diagnostic, reference or verification
procedures have been completed. This exemption ensures that clinical
diagnostic procedures are not impeded and also averts the problem of
having the system deal with several hundred thousand clinical
laboratories and shipments of routine diagnostic specimens.
Regulations promulgated under the Antiterrorism Act of 1996 require
that laboratories shipping and receiving select agents follow the
biosafety guidelines in the CDC/NIH publication, ``Biosafety in
Microbiological and Biomedical Laboratories,'' Fourth Edition. These
regulations effectively codify biosafety guidelines for laboratories
receiving select agents. ASM members must abide by these regulations
and the ASM provides information on the regulations and the necessity
of compliance through its site on the Internet.
Extending Current Regulations to Possession
Indeed, the ASM favors extending the current CDC regulations to
cover possession of select agents that may be used for bioterrorism. In
1999 ASM testified that additional measures should be taken to
``prohibit possession of listed biological agents or listed toxins
unless they are held for legitimate purposes and maintained under
appropriate biosafety conditions.'' ASM supported ``registration with
the CDC of every institution that possesses and retains viable cultures
(preserved and actively growing) of select agents along with the
concomitant duty to follow all regulatory requirements related to such
possession and usage. The ASM specifically recommended that:
``The CDC's responsibilities should include the duties to: (1)
Continue to establish and periodically revise the list of
select agents. (2) In accord with proper administrative
procedures, promulgate any additional regulatory measures
related to registration of facilities, establishment of
biosafety requirements, institution of requirements for safe
transportation, handling, storage, usage, and disposal of
select agents, and the auditing, monitoring, and inspection of
registered facilities. (3)The CDC should notify the Department
of Justice about any concerns that it may have about
institutions that possess select agents.''
The ASM believed then, and continues to believe today, that the law
should prohibit institutions and individuals from possessing cultures
of select agents unless such institutions or individuals maintain the
agents underappropriate biosafety and biosecurity conditions.
We believe H.R. 3162, Section 817, benefited greatly from
discussions with the scientific community to avoid unintended
consequences. The language originally proposed in early drafts of this
provision illustrated the difficulties of criminalizing use of
biological agents and did not take into account the fact that
biological agents exist naturally in the environment. The final
language in HR 3162, which we support, takes into account this
qualification and excludes bona fide research from the reach of the
revised Section 175 of Title 18.
The ASM agrees that the possession of biological agents, toxins,
and delivery systems should be for prophylactic, protective, bona fide
research, or other peaceful purposes. The ASM also completely agrees
that some individuals should not have access to select agents.
Therefore, we agree with the basic tenet of the provision that prevents
restricted persons from knowing possession of a select agent. Candidly,
the ASM believes the Act should have permitted the Attorney General,
upon recommendation of the Secretary of HHS, to waive the prohibition
against possession of select agents by aliens from countries designated
as supporting terrorism if, and we emphasize this point, if there was a
specific finding that a waiver for the particular individual served our
national interest. However, our disagreement with the failure to
provide the opportunity for a waiver for specific aliens does not
diminish our support for the concept of setting reasonable limits upon
persons who may possess select agents.
The ASM further supports the development of standards for
possession of select agents to prevent access to such agents for use in
terrorism. By placing this requirement within the structure of the
Antiterrorism and Effective Death Penalty Act of 1996, Congress
recognizes the benefits of using the existing regulatory system. The
ASM concurs. The CDC is the only federal agency with the expertise and
experience to act quickly and competently in this area. Further, and
very importantly, the CDC currently possesses the confidence of the
scientific community that it will act responsibly to balance the
interests of preventing bioterrorism and advancing research in the area
of infectious diseases and clinical diagnostic measures.
In summary, Congress has taken several significant steps in dealing
with the threat of bioterrorism. Today, possession or use of a
biological agent or toxin as a weapon is a serious criminal offense;
knowing possession of a biological agent, toxin, or delivery system, of
a type or quantity, not reasonably justified by peaceful purposes is a
serious criminal offense; it is a serious criminal offense for persons
who have engaged in specific types of misconduct to possess, ship, or
receive select agents; a facility must register with the Secretary of
HHS before transferring or receiving a select agent. These are
significant steps in the right direction, but the ASM agrees that
Congress must do more. We submit that, in taking additional action,
Congress and federal agencies should continue to consult carefully with
the scientific community to achieve the critical balance that is the
underlying theme of our testimony.
Comments on Pending Legislative Proposals
Given that a number of legislative proposals are being considered,
it is to that legislation that we now direct our attention. In the
remainder of our testimony, we will address legislative proposals for:
listing of select agents; registration of facilities possessing select
agents; the definition of restricted individuals; imposition of civil
penalties; unsafe handling provision; proposals for licensure of
equipment; and the need for federal support of aggressive
countermeasures programs.
a. listing of select agents posing a threat of bioterrorism
ASM supports the need for periodic reviews of the list of select
agents. These reviews must include consideration of agents that may be
used in domestic or international bioterrorism. We believe that the CDC
is the proper agency to lead such reviews. Such reviews must, and
undoubtedly will, include close coordination and communication with
other government agencies. Further, the CDC should view the scientific
community as a partner in these endeavors. Only through active
consultation with scientists may the CDC and other federal agencies
hope to achieve a comprehensive, integrated regulatory system that
serves the public interest by preventing terrorism without undue
disruption of vital research and clinical diagnostic testing.
b. registration of facilities for possession of select agents
The ASM supports registration of laboratories that possess select
agents and recommends that CDC conduct registration as an extension of
the current select agent rule.
1. The Need for Registration. The CDC, acting in cooperation with
the scientific and biomedical communities, and with public notice and
input, should establish rules and provide regulations for governmental
monitoring of possession of select agents posing a risk of
bioterrorism. The registered institution must be responsible for
assuring compliance with mandatory procedures and for assuring fully
appropriate biosafety mechanisms, including appointment of a
responsible official to oversee institutional compliance with biosafety
requirements. It is the institution that ultimately is responsible for
ensuring compliance with its legal and regulatory obligations.
These institutional responsibilities include assuring safety
through proper procedures and equipment and through training of
personnel. Thus, the institution must bear the final responsibility for
training employees regarding the biosafety requirements, including the
necessity for following those requirements, including such duties as
reporting isolation of select agents or any breach in a biosafety
protocol.
As institutions comply with appropriate safeguards, scientists may
undertake their research with knowledge of clear procedures and with
assurance that compliance with such procedures fulfills governmental
requirements related to select agents. The institutions also should be
required to maintain records of authorized users and to ensure that
users are properly trained, as is currently the case for work with
radioisotopes. Intentional removal of select agents from a registered
facility should subject the individual to criminal sanctions.
However, in light of the expedited deadlines that are likely to be
imposed for initial reporting, facilities should be allowed to report
select agents found after the initial reporting deadline without
incurring severe penalties. If strong sanctions are imposed at an early
point, some institutions may be forced to destroy collections if they
have not been able to determine whether they are free of select agents
by the reporting deadline. Time is of the essence, and compliance with
appropriate procedures is important. However, we need not act with such
haste in the reporting area that entire collections are lost solely due
to the inability to complete an inventory process by an arbitrary
deadline.
2. Procedures: Registration, Inspections, and Regulations. CDC has
an existing inspection mechanism. Additionally, the existing select
agent rule incorporates biosafety and biosecurity procedures from the
CDC Biosafety Manual. That manual is an appropriate starting point for
standards and procedures in laboratories possessing select agents. The
ASM understands that this Subcommittee is considering a
``certification'' program. We are not certain whether ``certification''
would mean something more than mandatory registration, safety and
security procedures, standards, training, proper laboratory facilities
to contain and dispose of select agents, and inspections, all of which
the ASM supports.
We believe reasonable allowance should be made for the reporting of
select agents later if they are discovered in inventories of archived
samples. Otherwise, laboratories may need to destroy potentially
valuable research tools. Institutions should report possession when
they become aware of an agent they did not know they possessed without
penalty.
3. Congress Must Recognize that Pathogens Occur in Nature and Craft
Legislation Accordingly. Current legislative proposals appear to deal
exclusively with research laboratories and to ignore the clinical side
of the microbiological sciences. Consequently, the proposals ignore
many of the exclusions that need to be made and which have been
recognized in other legislation.
For example, regulations should provide exemptions for laboratories
on the same basis as they are granted under the current regulations for
shipment and receipt of select agents at 42 CFR Sec. 72.6(h). Further,
the proposals should exempt state public health and veterinary
laboratories as they deal with naturally occurring pathogens without
any effort to cultivate, collect, or extract such pathogens in a manner
that lends itself to bioterrorism or public health risk.
In this vein, we know that Congress understands that pathogens
exist in nature and people develop diseases from some of these
pathogens each year. We recognize that the proposed definitions of a
biological agent and toxin exclude a biological agent or toxin that is
in its naturally-occurring environment, if it has not been cultivated,
collected, or otherwise extracted from its natural source. ASM is
uncertain that such language will prevent the unwarranted application
of penalties to areas of scientific inquiry of naturally occurring
phenomena. Legislation should focus on cultures rather than organisms.
4. Laboratory Practices. Registration with the CDC is tantamount to
certification under current law. Language in some proposals we have
seen raises difficult issues related to laboratory practices and the
scope of application of procedures to individuals. Are individual
couriers (or their employing enterprises) that transport select agents
going to be certified? The scientific community must be able to get
samples through the Laboratory Response Network to the public health
labs and the CDC. In addition, cultures of some of these agents are
transported to reference laboratories for identification. Certainly,
proper procedures must be established and followed for the shipment of
select agents but the CDC will need to consider carefully each of these
special circumstances in developing regulations. Congress should not
mandate procedures that prevent such consideration and the crafting of
regulations that protect the public but permit maximum, appropriate
freedom for the scientific research community and as expeditious as
possible action by clinical diagnostic laboratories. Again, the ASM
believes the CDC's Biosafety Manual, which covers both biosafety and
biosecurity, should be the starting point for such regulations.
5. Disposal of Select Agents. Although the specific mandate may be
left for regulation, ASM suggests that an appropriate authority should
require destruction of pathogens within laboratories rather than
through disposal as medical waste. Although the ASM does not discount
entirely the possibility for exceptions, as a rule, pathogenic
organisms should be destroyed (even by clinical laboratories) inside
the laboratory. These materials should be autoclaved or killed by other
means before disposal as waste in landfills. We recognize that this
could require significant costly changes in protection currently
employed by some diagnostic laboratories.
6. Protection of Intellectual Property. The ASM recognizes that
existing legislative proposals contain provisions protecting
information on registration statements from disclosure under the
Freedom of Information Act. Certainly, such a provision must be
included in any legislation. Congress, CDC, and other federal agencies
must respect and protect the intellectual property rights of
individuals and enterprises. Any authorized disclosure of such
information must result in the imposition of a penalty upon the person,
including government employees, responsible for a violation. We must be
certain that confidential information is secure and protected.
7. Physical Security of Facilities. CDC and research laboratories
recognized previously that the regulatory regime governing access to,
and use of potentially dangerous biological agents, needed to
anticipate theft or intentional misuse. Existing biosafety guidelines
categorize biological agents into four groups according to the highest
level of physical containment that is necessary to protect those who
work with these agents or those in the surrounding environment. They
specify access controls and physical barriers to agent release. In our
new environment, CDC and laboratories will need to review carefully
requirements for the physical security of facilities that house select
agents. We must prevent unauthorized individuals from obtaining these
agents. Government must recognize that increased security and limiting
access to select agents will impose costs and other burdens on
facilities and researchers who use these agents for legitimate
research.
The ASM urges, as with all aspects of eventual regulations, that
the government impose security measures that are proportionate to the
expected improvement in public safety. ASM will support such rational
measures and is confident that the research community will accept costs
that are proportionate to their benefits. As institutions develop and
institute new standards for physical protection resulting in increased
financial and operational implications, government assistance in
offsetting costs of such security improvements is appropriate.
At the same time the ASM recognizes and supports the need for
heightened awareness of the need for physical security, it recognizes
that there are various sources of supply of dangerous agents. There
should be no illusion that tightening security and access controls at
research institutions in the United States will solve the bioterrorism
problem. To the maximum extent possible, the United States should
strive to extend reasonable physical security standards to laboratories
on an international basis.
c. definition of restricted individuals
Congress must recognize that research regarding the causes and
remedies for infectious disease proceeds on a global scale. For
example, hundreds of foreign scientists attend scientific conferences,
not just to learn but to contribute importantly to the exchange of
scientific information. There are many hundreds or thousands of foreign
nationals at work in laboratories in the United States where they are
contributing to biomedical research.
A broad, mandatory prohibition that could significantly exclude
qualified aliens from work in research and diagnostic laboratories is
not in the best interest of the United States. The broad exclusion of
aliens could have a serious impact on academic medicine. Almost
certainly, it would restrict collaborative studies and critical
training of individuals who will deal with the many diseases that occur
throughout the world requiring advanced diagnostic methods and
treatments.
1. Treatment of Aliens. Under the USA PATRIOT Act (H.R. 3162), the
term ``restricted person'' includes aliens from countries designated by
the U.S. as supporting terrorism. H.R. 3160 goes further and would
expand that exclusion to all aliens admitted to the United States under
a non-immigrant visa. We recognize that H.R. 3160 permits the Secretary
to designate categories of individuals who have expertise valuable to
the United States. However, without knowing the intended scope of this
provision, we are very concerned that the initial classification of all
aliens as restricted persons may adversely affect legitimate and
essential biomedical research, including diagnostic laboratories. These
laboratories are critical for diagnosing anthrax and diseases that may
be caused by other biothreat agents.
ASM favors the narrower restriction on individuals from countries
that are designated as supporting terrorism as enacted in the USA
PATRIOT Act (H.R. 3162). Even then, as we testified before, we believe
that Congress should authorize the Attorney General to grant a waiver
for specific foreign nationals from those nations when it is in the
interest of our nation.
If Congress finds that it must impose broadened restrictions on
alien scientists, the Committee could include a special provision
regarding registration by aliens and/or by the facility at which they
work. Such a specific statement would alert authorities to the identity
and presence of an alien at a facility and permit a greater degree of
scrutiny. Finally, if Congress decides to retain a general prohibition,
it should modify the current waiver language (``expertise valuable to
the United States regarding select agents'') to permit the Secretary to
include other categories that the Secretary finds to be ``in the
interest of the United States.''
2. Testing of Drug Abusers. The definition of ``restricted
persons'' in H.R. 3160 refers to 18 U.S.C. Sec. 922(g) that, in turn,
includes any person ``who is an unlawful user of or addicted to any
controlled substance.'' The ASM assumes that inclusion of this category
of individuals within the meaning of restricted persons will not
require mandatory pre-employment or on-going drug testing of employees.
If Congress intends to require mandatory drug testing, it should do so
explicitly rather than through reference to 18 U.S.C. Sec. 922(g).
d. imposition of civil penalties
Current legislative proposals establish very substantial civil
penalties for individuals or entities that violate regulations on the
shipment, receipt, or possession of select agents. These penalties may
reach $250,000 on individuals and $500,000 on any other person. The
present regulations governing shipment and receipt of select agents
provide for a criminal fine or penalty for violations of the
regulations. To the best of the ASM's information, no prosecution has
occurred under this provision. Of course, there is a substantial
difference between a criminal prosecution under a ``reasonable doubt''
standard of proof and the imposition of a civil penalty.
As we testified earlier, the ASM envisions an integrated,
comprehensive set of guidelines for the possession of select agents.
The ASM has suggested that the CDC's guidelines in its manual
``Biosafety in Microbiological and Biomedical Laboratories'' should be
the starting point for any regulations.
Imposition of civil penalties on individuals or facilities is an
area in which it is especially important to strike the proper balance
between deterrence of bioterrorism and protection of the public welfare
versus discouragement of scientific research and clinical laboratory
diagnostic testing. The ASM understands and supports the need for a
substantial inducement for compliance with regulations regarding
possession of select agents. At the same time, the Committee should
recognize the significance of imposing civil penalties and the impact
of potential penalties up to $250,000 on individual employees. A civil
penalty provision must be a thoughtful and well-designed provision.
The provision should take into account and specify: (a) in the
first instance the facility, rather than an individual, is liable; (b)
standards for determination of the amount of a penalty based upon a
host of factors including the size of the facility, the significance of
the violation, the degree of culpability, and other factors; (c)
mitigating circumstances; (d) the means for adjudicating liability for,
and the amount of, the penalty, (e) other factors related to a system
for adjudicating civil liability. The Committee should not adopt a
measure that simply provides for a penalty without any of the details
necessary to assure the fair and appropriate administration of the
penalty. To do so would engender unnecessary and unwarranted fears and
burdens upon the very persons who are at the forefront of dealing with
the threat of bioterrorism as well as the ongoing hardship of
infectious diseases.
e. unsafe handling provisions
The ASM supports the principle that scientists must follow safe
practices. Perhaps more than anyone else, ASM members recognize that
unsafe handling of such agents places workers and the public at severe
danger.
Of course, requirements related to handling procedures are largely
not relevant to the prevention of bioterrorism. The prospect of a
criminal penalty for unsafe handling of select agents will not deter a
bioterrorist. Only in the area of assuring the security of select
agents are handling procedures related to bioterrorism.
Handling procedures are relevant to the more general issue of
protecting the public welfare related to laboratories that possess
select agents. However, the specter of severe criminal penalties on the
basis of laboratory procedures raises perhaps one of the most difficult
areas for balancing between protection of the public and chilling the
willingness of laboratories and scientists to engage in important
research. Criminal penalties based on imprecise legal standards may
unduly impede research. The ASM believes that the urgency with which
the Congress is now dealing with the threat of terrorism does not make
this a good time to strike the appropriate balance in this area. In
this regard, the ASM does support the registration of laboratories and
individuals. It further supports a duty to comply with ``Biosafety in
Microbiological and Biomedical Laboratories,'' Fourth Edition.
For the present, the ASM believes regulations based on these
standards and practices by laboratories in the context of the
registration process is the best approach in this area as they provide
standards that are clear and coherent, streamlined and integrated,
based on real risks, and effectively communicated to research
facilities and individual researchers. It allows the scientific
community a better understanding of what they are prohibited from
doing, rather than attempting to follow an amorphous negligence or
recklessness standard that is understood by attorneys but with which
most scientists are unfamiliar. The goal of legislation must be sound
scientific practices rather than a chilling of scientific inquiry
through the threat of criminal penalties under imprecise standards.
f. licensure of equipment
The ASM understands and appreciates the concept that it may be
easier to control the possession of pieces of equipment used for
manufacture of weapons of bioterrorism than the actions of individuals
or the quantities of select agents. The ASM further appreciates that,
rather than specifying equipment or controls, the proposed legislative
language we have seen would require promulgation of regulations after
consideration of a broad range of factors. Indeed, in many respects, it
is accurate to say that the weaponization of a biological agent raises
engineering issues rather than microbiological issues.
At the same time, to be realistic, we must recognize that efforts
to control equipment almost invariably encounter the problems that
would limit the effectiveness of such measures. For example, equipment
that could produce biological weapons is in wide use and as equipment
is regulated, terrorists will turn to other types of equipment.
It is our understanding, for example, that UNSCOM revealed that
Iraq was able to produce large quantities of biological weapons without
using sophisticated fermentors. As worrisome as it may be, small
flasks, canisters, home brewing bottles, and other similarly mundane
equipment provide all that is needed to grow the bacteria that cause
anthrax, plague, and other select agents. Thus, we must at least
question the benefits of establishing any significant regulatory burden
on a list of equipment and particularly the types of equipment found in
many research and clinical laboratories as well as the biotechnology
industry. For example, virtually every industrial biotechnology
operation uses controlled fermentors. Every pharmaceutical company uses
them and many universities have this equipment as well.
To cover the size relevant for bioterrorism one would have to
capture everything of 5 liters and above and that would still not
eliminate the possibility of growing the organisms in simpler vessels.
Similarly, large temperature controlled centrifuges are present in
virtually all microbiology and biochemistry laboratories, often many
per lab. Certainly, biosafety hoods are present in most if not all
clinical labs as well as many research labs. These hoods prevent
environmental exposure to the pathogens being worked on. Freeze drying
equipment is very widely distributed in research labs as well as in
various industrial settings such as coffee making.
In essence, this is a cost-benefit issue for the Congress. There
may be relatively little to gain by imposing an extensive regulatory
regimen on widely used legitimate equipment, such as centrifuges,
laminar flow hoods and fermentors. Indeed, we again point out that at
this point, we do not know if the anthrax used in the bioterrorist
attacks was produced overseas or in domestic facilities.
g. federal support of aggressive countermeasures programs
The ASM endorses significant government funding for development of
countermeasures. Although we can never provide absolute protection, we
can take aggressive steps to be prepared to control and counteract an
attack. We need to be better prepared for a bioterrorist attack by
spending the time, effort, and funds necessary to develop new vaccines
and pharmaceuticals. Of course, we hope that we never need to use such
new products to deal with a substantial bioterrorist attack. If one
occurs, however, we need to have such protection. If we are fortunate
and avoid such attacks, then the research inevitably will serve the
important purpose of combating infectious diseases and, therefore, will
serve the interest of every person on the globe.
Concluding Remarks
In conclusion, legislative actions to enhance national security by
adding protection against the criminal acts of bioterrorism can and
must be done in a way that does not have a detrimental impact on the
legitimate biomedical research. We need to improve the health of
Americans and those beyond our shores. We need to ensure that we will
have the vaccines, pharmaceuticals, and diagnostic capabilities to
protect the public health of all Americans in the future from both
natural infectious diseases and those from criminal bioterrorist
attacks.
In doing so we must recognize that biomedical research is a global
effort. If we fail to eradicate infectious diseases that occur
primarily in other countries we run the risk that those diseases will
threaten our country. We must work across international borders to
improve public health and to combat the natural occurrences of
infectious diseases that threaten global security. We cannot isolate
our biomedical research community by excluding those legitimate
scientists from other countries who like American scientists are
fighting against the dreaded impacts of infectious diseases. The war
against infectious diseases and the scientific and university
communities around the world must join in the battle against
bioterrorism.
We support a strengthened biological weapons convention that would
criminalize the misuse of biological agents and the establishment of
acceptable normative practices for the shipment, possession and safe
use of select agents. We support the ongoing initiative of the
Administration to strengthen the Biological and Toxins Weapons
Convention and to achieve this aim through mechanisms that would
harmonize the legal and regulatory frameworks for the possession, use
and exchange of select agents, adopted in the United States with those
of other nations. We support the efforts of Congress and the
Administration to deter bioterrorism and provide strict criminal
penalties for those who carry out egregious acts using biological
weapons.
Even as we strive to prevent bioterrorism, we must recognize that
no set of regulations can provide absolute protection against
bioterrorism. Even as we strive to prevent acts of bioterrorism, we
also have a duty to pursue research and public health improvements
aimed at developing the most effective possible responses to acts of
biological terror. Research and public health responses related to
effectively combating an act of terror are a critical component of the
public policy response to the threat that exists.
Chairperson Feinstein. Thank you very much and I certainly
hope you are correct. Thank you.
Next I would like to introduce Michael V. Drake, M.D., vice
president of health affairs for the University of California
Office of the President. Dr. Drake was appointed University of
California's systemwide vice president for health affairs in
March of 2000. He oversees education and research activities at
the University of California's 15 health sciences schools. That
is medicine, dentistry, nursing, pharmacy, public health,
optometry, veterinary medicine, including five academic medical
centers--UC-Davis, UC-Irvine, UCLA, UC-San Diego and UC-San
Francisco. The university is the largest single producer of
trained physicians in the United States.
He is a member of several scientific and scholarly
societies and he is also the principal investigator on active
grants and contracts, totalling more than $11 million, and is a
practicing ophthalmologist. We are delighted to have you with
us, Dr. Drake.
STATEMENT OF MICHAEL V. DRAKE, M.D., VICE PRESIDENT FOR HEALTH
AFFAIRS, UNIVERSITY OF CALIFORNIA, AND STEVEN P. SHEARING
PROFESSOR, DEPARTMENT OF OPHTHALMOLOGY, UNIVERSITY OF
CALIFORNIA, SAN FRANCISCO SCHOOL OF MEDICINE, SAN FRANCISCO,
CALIFORNIA
Dr. Drake. Thank you very much, Senator Feinstein.
Madam Chair, distinguished members of the Committee, I
would like to request that my written testimony be submitted
for the record.
Chairperson Feinstein. So ordered.
Dr. Drake. I have been asked to speak on our responses to
the events of the last several weeks. In response to the
unfortunate case of inhalation anthrax in Florida in early
October, California Governor Gray Davis contacted the
University of California and other institutions with questions
regarding our state's ability to respond to such an attack. He
followed this contact with an executive order establishing,
under the auspices of the State Strategic Committee on
Terrorism, a series of Subcommittees, including the
Subcommittee on the Protection of the Public Health. I co-
chaired this Committee, along with Dr. Diana Bonta, director of
the California Department of Health Services. The Committee met
on October 19 and submitted its confidential report to the
governor on October 25. The Committee includes representatives
from the University of California, medical and health care
associations, public health organizations and state agencies
and departments.
While the specific recommendations to the governor remain
confidential due to the sensitive nature of the information, I
am pleased to share with you today a general sense to the
Committee on several important issues related to bioterrorism.
First and foremost, our Committee found that there is a
great need to improve the communication between and training of
personnel in the continuum of public health services, from the
initial response teams to the treating physicians and nurses.
This involves improving information services directed at both
public health professionals and the general public, improving
coordination among local, state and federal agencies, and doing
all of this in ways that will strengthen the public health
system, even in the hopeful event that no further terrorist
attacks occur.
Several efforts in this regard have been initiated by the
CDC and obviously the events of the past several weeks teach us
that we should accelerate our efforts to make these programs
fully operational and to expand their reach.
In all cases it is crucial to make certain that our crisis
management infrastructure and protocols enhance our ability to
manage the ubiquitous chronic problems that affect the public's
health on a daily basis. There is a common aphorism used on the
wards of our teaching hospitals that states, ``When you hear
hoofbeats it is more likely to be a herd of horses than a
stampede of zebras.'' Stated differently, common diseases occur
in uncommon ways more often than uncommon diseases occur.
In preparing for attacks of bioterrorism we are guarding
against the uncommon but we must not lose sight of the myriad
problems that we were dealing with on September 10. We were
very engaged in issues of great importance to the health of the
public on a daily basis and those problems did not disappear on
September 11. Our public health system is understaffed and
underfunded. Many Americans are vulnerable to disease and
injury in ways that we could avoid. We should seek solutions
that not only enhance our national security but that also
improve the public safety.
In demographically diverse states like California, it is
very important to provide public information in a culturally
competent manner and in multiple languages.
In addition to the public health response, university
faculty are actively pursuing solutions to problems that may
affect us in the future. For example, researchers working in
the field of biofiltration are investigating ways of removing
highly toxic materials from the air, as well as novel detection
techniques and methods for degrading toxic pollutants.
Researchers in the Environmental Energy Technology Division at
the Lawrence Berkeley National Laboratory are developing
building management strategies to reduce occupant exposures to
an unexpected release of toxic aerosol or gas.
Although much of our country's attention over the past
month has been appropriately focussed on bioterrorism, we
remain cognizant of the possibilities of other threats, as
well. And two of our newly funded state initiatives, the
California Institutes for Science and Innovation, are also
conducting research in ways to defend critical infrastructures,
such as telecommunications, the power grid, air traffic control
system and financial markets.
Our research scientists are critical to this endeavor in
another way. At a recent meeting hosted by the Association of
Academic Medical Centers, Tara O'Toole from the Center for
Civilian Biodefense Studies at Johns Hopkins, observed that
biology is on the precipice of losing its innocence in the 21st
century the way that physics lost its innocence in the 20th
century.
But unlike weapons of mass destruction arising from the
realm of physics, biological weapons did not necessarily
require a state-supported program. They can be developed by a
few individuals with fairly modest resources. We will be
increasingly dependent on the scientific community to work with
law enforcement and other branches of government to develop
effective measures for ensuring the public safety. My
colleagues at the University of California, and I am certain I
speak for the faculty at other academic institutions, as well,
would welcome the opportunity to work with you on developing
policies that increase laboratory security without compromising
laboratory research.
Our fundamental mission, of course, is education and we
have added new courses for our students and our broader
constituency to learn more about the potential causes, effects
and repercussions of terrorism on our shores. For example, 50
new courses were added at UCLA and at UCSF the noon lecture
series open to the public has begun a series featuring
discussions of topics ranging from bioterrorism to religious
intolerance.
The Association of American Medical Colleges last week
announced an initiative to help educate and prepare the
nation's physician workforce to respond appropriately to
terrorist attacks and one component of this project will focus
on integrating bioterrorism education into the medical school
curriculum. I note that when I was in medical school in the
early 1970s we learned about smallpox and then that was removed
from the curriculum because this was a disease that had been
eliminated. This year it was re-added to the curriculum.
Research universities take seriously their public service
responsibility to respond to threats to our health and
security. This is particularly clear to us at the University of
California because of our half century of management of the
national labs in Berkeley, Livermore and Los Alamos. The
marriage between academic scientific inquiry and national
security has been sound and mutually beneficial and we, along
with our sister institutions, stand ready to address prevention
and response to attacks and natural disasters. We are actively
pursuing these issues at the present time and look forward to
working with you as we refine and improve our programs that
address the reality of terrorism in the future.
Senator on behalf of the University of California, we
applaud your leadership on this issue and we look forward to
working with you and your colleagues as you continue to work on
the many difficult issues facing the nation. Thank you for your
time and attention.
[The prepared statement and an attachment of Dr. Drake
follow:]
Statement of Michael V. Drake, M.D., Vice President for Health Affairs,
University of California, Office of the President and Steven P.
Shearing Professor, Department of Ophthalmology, University of
California, San Francisco School of Medicine
Madame Chair, Distinguished Members of the Subcommittee: I am
Michael V. Drake, Vice President for Health Affairs at the University
of California and a member of the faculty at the University of
California, San Francisco School of Medicine.
The University of California's mission includes a strong emphasis
on basic research in the public interest. The University manages 10
campuses and three national laboratories, including 15 health sciences
schools such as medicine, public health, and veterinary medicine.
Speaking of the national laboratories, UC is proud of the
contributions for over 50 years by our faculty and staff to our
nation's national security through the Los Alamos, Lawrence Livermore
and Lawrence Berkeley national laboratories. Scientists at Lawrence
Livermore, for example, have developed an advanced hand held analyzer
that can identify pathogens based on DNA. Some cities have already
deployed this device. At Los Alamos, researchers have developed
technologies that can identify the unique origins of biological
organisms based on DNA. This technique can help authorities establish a
library of genetic profiles of different strands of organisms,
including anthrax.
A Coordinated, Statewide Response
In response to the discovery of anthrax in Florida in early
October, California Governor Gray Davis contacted the University of
California and other institutions around the state to learn more about
this biological agent and our state's ability to respond to such an
attack. He followed this contact with an Executive Order establishing--
under the auspices of the State Strategic Committee on Terriorism--a
series of subcommittees, including the Subcomittee on the Protection of
the Public Health. Along with Dr. Diana Bonta, Director of the
California Department of Health Services, I co-chaired this committee.
The committee met on October 19 and submitted its confidential report
to the Governor on October 25. Per the executive order, the committee
includes ``representatives from the University of California, medical
and health care associations, public health organizations and state
agencies and departments.''
While the findings and recommendations to the Governor remain
confidential due to the sensitive nature of the information, I am
pleased to share with this committee today a general summary of our
findings and recommendations on several important issues related to
bioterrorism.
Our subcommittee found that there is an acknowledged need to
improve the communication between and training of personnel in the
continuum of public health services, from the initial response teams to
the treating physicians and nurses. This involves improving information
services directed at both public health professionals and the general
public; improving coordination among local, state and federal agencies;
and doing all of this in ways that will strengthen the public health
system, even in the hopeful event that no further terrorist attacks
occur.
As part of the 1999 Bioterrorism Initiative of the Department of
Health and Human Services, the Centers for Disease Control and
Prevention took the lead in an effort to improve the nation's ability
to respond to an attack. A multi-faceted program is currently underway.
The Rapid Response and Advanced Technology laboratory and the newly
established National Pharmaceutical Stockpile Program are products of
this effort. The Health Alert Network, National Electronic Data
Surveillance System and the Epidemic Information Exchange will
facilitate communication among health professionals, particularly
between clinical providers and public health officials and
epidemiologists. Obviously the events of the past several weeks teach
us that we must accelerate our efforts to make these programs fully
operational and expand their reach.
In all cases it is crucial to make certain that our crisis
management infrastructure and protocols enhance our ability to manage
the ubiquitous chronic problems that affect the public's health on a
daily basis. There's a common aphorism used on the wards of our
teaching hospitals that states : ``When you hear hoof beats it's more
likely a herd of horses than a stampede of zebras.'' Stated
differently, common diseases occur in uncommon ways more often than
uncommon diseases occur. In preparing for attacks of bio-terrorism we
are guarding against the uncommon. But we must not lose sight of the
myriad problems we were dealing with on September 10th. We were very
engaged, rightfully so, in issues of great importance to the health of
the public on a daily basis. Those problems did not disappear on
September 11th, although they have been obscured to some degree by the
enormity of the events of that day, and the unfortunate biologic events
of the past month. Ideal solutions must address both of these concerns.
Our public health system is understaffed and under funded; many
Americans are vulnerable to disease and injury in ways that we could
avoid. We should seek solutions that not only enhance our national
security, but that also improve the public safety.
In demographically diverse states like California it is important
to provide public information in a culturally competent manner and in
multiple languages. Recent health care financing decisions, which have
led to the increased marginalization of vulnerable communities, have
had the additional effect of compromising the State's ability to deal
with serious public health challenges regardless of the origin (i.e.
terrorism or a naturally occurring epidemic).
Universities and Academic Medical Centers
In addition to the public health response, the University of
California, like other universities in the state and across the nation,
has volunteered assistance and expertise in many ways. While some of
the work has taken place in specific response to recent events, much of
it highlights or accelerates activities that were already underway. For
example, University faculty working in the field of bio-filtration are
investigating ways of removing highly toxic materials from the air, as
well as novel detection techniques and methods for degrading toxic
pollutants. Researchers in the Environmental Energy Technology Division
at Lawrence Berkeley National Laboratory are developing building
management strategies to reduce occupant exposures to an unexpected
release of a toxic aerosol or gas.
Although much of our country's attention and concern over the past
month has appropriately focused on bio-terrorism, we remain vigilant to
the possibilities of other types of threats as well. Within the field
of cybersecurity, researchers are exploring new developments in
computer security, encryption, online secrecy and monitoring of
Internet communications. The Center for Digital Security at UC Davis,
with funding from the United States Air Force, uses physical and
mathematical modeling to investigate threats to communications networks
that might develop in the next five to ten years and countermeasures
that will allow people to defend these networks. Two of our newly
funded California Institutes for Science and Innovation are also
conducting research into ways to defend critical infrastructures such
as the telecommunications system, power grid, air traffic control
system and financial markets against physical cyber attacks.
UC also continues to work internally with university officials to
assess the levels of campus and laboratory security, both in terms of
employee safety, which has properly been the overriding focus of
regulations over past years, and in terms of protecting valuable
laboratory equipment, and materials. Laboratory safety and laboratory
security are related, but not identical. Developing procedures for
protecting the public from exposure risk to hazardous substances is an
ongoing enterprise, and applicable campus and government regulations
have been re-examined by campus officials. These steps take place on
top of already stringent laboratory security response procedures. For
instance, in regard to anthrax, which is often collected from the field
and freeze-dried for use by diagnosticians, isolates are kept in a
separate, locked area in a locked keycard access room. Any sharing of
these samples must be cleared first with the CDC.
Our research scientists are critical to this endeavor in another
way. At a recent meeting hosted by the Association of Academic Health
Centers, Tara O'Toole from the center for Civilian Biodefense Studies
at Johns Hopkins observed that biology is on the precipice of losing
its innocence in the 21st century, the way that physics lost its
innocence in the 20th. Unlike weapons of mass destruction arising from
the realm of physics, biological weapons do not necessarily require a
state supported program. They can be developed by a few individuals,
with fairly modest resources. We will be increasingly dependant on the
scientific community to work with law enforcement and other branches of
government to develop effective measures for insuring the public
safety. It is important that the federal government continue to work
with the scientific community on this issue, and that we avoid
regulations or policies that curtail the ability of our scientists to
advance their craft in beneficial ways. My colleagues at the University
of California, and I am certain I speak for faculty at other academic
institutions as well, would welcome the opportunity to work with you on
developing policies that increase laboratory security without crippling
laboratory research.
Another area in which the University's faculty and academic medical
centers can have an immediate impact is by providing timely information
to our students, residents and other trainees, as well as the
practicing community and general public. Academic medical centers--
enterprises that include a hospital, medical school, and at least one
other health sciences school, such as a school of nursing or pharmacy--
serve as a unique locus for education, training and multi-disciplinary
research. With their academic and volunteer faculty, they also provide
an important link to medical practitioners in the community. Although
the vast majority of physicians will not see a case resulting from a
chemical or biological attack, our hospitals and community providers
will see an influx of frightened patients with flu symptoms this
winter. We must arm practitioners with the ability to tell the
difference, and to address the mental health issues that arise in a
population living in a heightened state of anxiety.
Collectively, the country's academic medical centers are also
organizing several new activities that will pool their resources and
strengths. The Association of Academic Health Centers is addressing
this issue. As part of this effort it held a day long planning meeting
here in Washington yesterday in advance of a national meeting devoted
to the topic of the appropriate bio-terrorism response for academic
medical centers across the country. And joined by some of your esteemed
colleagues, the Association of American Medical Colleges last week
announced an initiative to help educate and prepare the nation's
physician workforce to respond appropriately to terrorist attacks. One
component of this project will focus on integrating bio-terrorism
education into the medical school curriculum.
Research universities, medical schools, and academic medical
centers take seriously their public service responsibility to respond
in any appropriate manner to major threats to our health and security.
This is particularly clear to us at the University of California
because of our successful half-century of management of the national
laboratories in Berkeley, Livermore, and Los Alamos. The marriage
between academic scientific inquiry and national security has been
sound and mutually beneficial. We, along with our sister institutions
here and around the world, stand ready to address prevention and
respond to terrorist attacks and natural disasters. We are actively
pursuing these issues at the present time, and look forward to working
with you as we refine and improve programs that address the reality of
terrorism in the future.
Senator, on behalf of the University of California, we applaud your
leadership in the wake of the recent threats to our homeland security
and we look forward to working with you and your colleagues as you
continue to work on the many difficult issues facing our nation.
Thank you for your time and attention. I would be pleased to answer
any questions you may have.
Executive Orders
executive department, state of california
executive order d-47-01 by the governor of the state of california
WHEREAS, on September 11, 2001, civilians, buildings and government
facilities in the State of New York, Washington, D.C. and the
Commonwealth of Pennsylvania were the target of multiple, coordinated
terrorists attacks causing tremendous damage, injury and loss of life;
and
WHEREAS, on September 14, 2001, the President declared a national
emergency as a result of these attacks; and
WHEREAS, on September 24, 2001, the President issued an executive
order finding that there is a continuing and immediate threat of
further terrorist attacks on the United States constituting an unusual
and extraordinary threat to the national security; and
WHEREAS, the federal government has primary responsibility for the
security and safety of the nation, state and local officials must
assure California's readiness to prevent and respond to terrorists
attacks and recommend such additional measures as may be necessary; and
WHEREAS, the California Anti-Terrorism Information Center was
established on September 25, 2001 to coordinate the exchange and
assessment of information regarding terrorism between state and local
law enforcement agencies within California; and
WHEREAS, in 1999, the Governor's Office of Emergency Services
joined with federal, state and local agencies to establish an inter-
disciplinary committee known as the State Strategic Committee on
Terrorism to plan for and develop programs to address terrorist
threats;
NOW THEREFORE, I, GRAY DAVIS, Governor of the State of California,
by virtue of the power and authority vested in me by the Constitution
and statutes of the State of California, including the Emergency
Services Act of Government Code section 8550 et. seq., do hereby issue
this order to become effective immediately:
IT IS ORDERED that the State Strategic Committee on Terrorism
shall:
1. evaluate the potential threat of terrorist attack;
2. review California's current state of readiness to prevent
and respond to a potential attack; and
3. establish and prioritize recommendations for prevention and
response.
IT IS FURTHER ORDERED that the State Strategic Committee on
Terrorism will consider the following areas:
The public and private infrastructure that support the
people and the economy of California;
The facilities and systems for manufacturing,
processing, transporting, disposing of and storing potentially
dangerous substances;
The farms, ranches, feeding, processing, storage,
delivery, and other systems that are part of the agricultural
industry;
The railways, bridges, roadways, terminals, ports, and
other transportation arteries;
The hospitals, emergency medical systems, and other
health facilities and systems that are critical to our ability
to rescue and administer to those who may be affected by
terrorist acts;
The computers, computer networks, and other computing
systems that provide essential data processing, systems
control, and information channels;
The procedures of agencies and departments responsible
for issuing licenses and/or regulating materials or processes
that pose a potential terrorist threat;
The public employees, facilities, and systems that
provide services necessary for the protection of our state.
IT IS FURTHER ORDERED that in developing its recommendations the
State Strategic Committee on Terrorism shall consult and coordinate
with the Commissioner of the California Highway Patrol, who serves as
the Governor's Intelligence Officer and liaison with the California
Anti-Terrorism Information Center.
IT IS FURTHER ORDERED that a Subcommittee on the Protection Public
Health to the State Strategic Committee on Terrorism be established to
develop recommendations on the public health response to biological and
chemical threats. The Subcommittee shall include representatives from
the University of California, medical and health care associations,
public health organizations, law enforcement, and state agencies and
departments.
IT IS FURTHER ORDERED that the State Strategic Committee on
Terrorism through the Office of Emergency Services shall include
consultation with leaders of private industry who have knowledge and
experience in security practices to solicit their expertise and
recommendations.
IT IS FURTHER ORDERED that the State Strategic Committee on
Terrorism shall facilitate the development and review of educational
and public information materials on prevention of and responses to
conventional, nuclear, biological, chemical, cyber and agricultural-
related terrorist threats.
IT IS FURTHER ORDERED that all State agencies reporting to the
Governor shall cooperate with the State Strategic Committee on
Terrorism and assist in the implementation of this Executive Order. All
other State agencies as well as federal and local agencies,
particularly those participating on the Committee, are requested to
assist the Committee in carrying out its responsibilities under the
Executive order.
IT IS FURTHER ORDERED that Dallas Jones, Director of the Governor's
Office Emergency Services and Chair of the State Strategic Committee on
Terrorism, shall report by October 30, 2001, the Committee's initial
recommendations in each of the above areas.
I FURTHER DIRECT that as soon as hereafter possible, this order be
filed in the Office of the Secretary of State and that widespread
publicity and notice be given to this order.
IN WITNESS WHEREOF I have hereunto set my hand and caused the Great
Seal of the State of California to be affixed this the tenth day of
October 2001.
Gray Davis
Governor Of California
Chairperson Feinstein. Thank you very much, Dr. Drake.
I would like to say that the record will remain open till
the end of the day to receive statements and I would like to
add to that record the statement of the chairman of the
Committee, Senator Patrick Leahy.
[The prepared statement of Senator Leahy follows:]
Statement of Hon. Patrick J. Leahy, a U.S. Senator from the State of
Vermont
I commend Senator Feinstein for holding this hearing on the threat
of bioterrorism. Today's discussion is important for both symbolic and
practical reasons.
It is symbolically important because, as everyone here knows, just
a few weeks ago, terrorists unleashed anthrax here in the Senate office
buildings. Today we are here to discuss how to overcome this threat.
But our very presence here is a testament to the resilience of the
Senate, and of the American people whom we are privileged to represent.
I would like to thank everyone who is here today, and the security and
public health personnel who have made it possible for us to be here
today, for all your hard work. By making this hearing possible, you
have sent a message loud and clear to the terrorists: no menace,
however scientifically sophisticated, will silence our democracy.
Today's hearing is practically important because we need to stay
one step ahead of the terrorists. The President has called on all
Americans to be on the alert. That means anticipating new dangers that
we have yet to encounter as well as improving our response to what we
have already seen. We here in the Senate can play our part in that
effort by doing what we do best: listening to the experts and then
crafting the rules that will enable our government to protect our
people and their liberties in the most effective way possible. That
process should be swift, but it should also be based on a careful
analysis of the facts, and on testimony that, insofar as national
security allows, is fully available to the American public. Today's
hearing is a key part of that process.
Some people, particularly our witnesses today, have been alert in
this area for a long time. I want to commend in particular Senator
Biden. Well before September 11 and the subsequent outbreak of anthrax-
related incidents, Senator Biden had been working to strengthen our
Federal laws regarding biological agents and toxins. It was a bill that
he introduced in the last Congress--the Dangerous Biological Agent and
Toxin Control Act of 2000--that provided the basis for the bioterrorism
provisions in the initial draft of the USA Act of 2001. These
provisions filled a gap in the Federal criminal code by creating new
criminal offenses relating to select biological agents and toxins, and
called for more exacting regulation of these substances by the Federal
Government.
Like the USA Act, the Administration's original proposal to
Congress included new crimes as well as certain regulatory provisions
that would have further strengthened our Nation's ability to protect
against bioterrorist attacks. Unfortunately, the Administration chose
to withdraw its regulatory proposals--and to oppose the stronger
regulatory language that Senator Biden and I had proposed--apparently
because of its inability to resolve inter-agency conflicts. Given the
grave importance of this issue, I urge the Administration to resolve
these disputes and work with the Congress to provide these additional
protections.
The other bioterrorism provisions in the Administration's original
proposal, with a few modifications that I will describe shortly, passed
the Senate on October 11 as part of the USA Act, S.1510. To my
surprise, the House dropped these provisions before passing a version
of the Senate-passed bill on September 12, but it eventually accepted
the Senate's position on the need for such provisions and added them
back to the final bill, renamed the USA PATRIOT Act.
As enacted, the USA PATRIOT Act creates two new criminal offenses
that address the threat of bioterrorism. The first prohibits certain
restricted persons from possessing select biological agents and toxins.
The definition of ``restricted persons'' was taken from the original
version of the USA Act, and includes non-resident aliens from countries
that support international terrorism. The Senate rejected an early
Administration definition of ``restricted persons'' that would have
included any alien admitted to the United States under a non-immigrant
visa--an unduly broad definition that was not in the best interest of
science and clinical medicine.
The second new offense created by the USA PATRIOT Act, punishable
by up to 10 years in prison, prohibits the possession of any biological
agent, toxin, or delivery system ``of a type or in a quantity that,
under the circumstances,'' is not reasonably justified by a peaceful
purpose. As originally proposed by the Administration, this provision
specifically stated that knowledge of whether the type or quantity of
the agent or toxin was reasonably justified was not an element of the
offense. Thus, although the burden of proof in a criminal prosecution
is always on the government, every person who possessed a biological
agent, toxin, or delivery system was at some level of risk. At my
urging, the Administration agreed to drop this portion of the
provision.
Nevertheless, I remain troubled by the subjectivity of the
substantive standard for violation of this new criminal prohibition,
and question whether it provides sufficient notice under the
Constitution. As I noted upon passage of the USA PATRIOT Act last
month, I also share the concerns of the American Society for
Microbiology and the Association of American Universities that this
provision will have a chilling effect upon legitimate scientific
inquiry that offsets any benefit in protecting against terrorism. While
we have tried to prevent against this by creating an explicit exclusion
for ``bona fide research,'' this provision may yet prove unworkable,
unconstitutional, or both. I urge the Justice Department and the
research community to work together on substitute language that would
provide prosecutors with a more workable tool.
In addition, I am heartened to see that the Department has been
aggressively addressing the serious issue of so-called ``hoax'' cases.
I note that law enforcement authorities have been able to prosecute
these cases using existing threat and false statement statutes, and
that they have been able to prosecute even ``non-credible threats and
hoaxes'' in this area, as the testimony today will show. I know that we
are discussing the need for additional legislation specifically dealing
with the area of hoaxes, but we must also be careful that if we act in
this area, that we craft any legislation to deal with the specific
problem of serious hoaxes that we are attempting to address. Overall,
as I said when we passed the USA PATRIOT Act, I believe it does a good,
though imperfect, job of strengthening the American people's protection
from bioterrorism. But there is more that we can do. I have identified
two areas for improvement--the loss of the original bill's regulatory
provisions and the subjectivity of one of the Act's new criminal
provisions. I hope we will be able to identify some more today. We must
always be on the alert for new threats and new and innovative ways of
dealing with them; and we must be prepared to fight the next battle
against bioterrorism, not just the last.
The threat of bioterrorism in America is no longer theoretical; it
is all too real. I thank the witnesses for coming today to share their
expertise on this important issue.
Chairperson Feinstein. I would now like to introduce John
Parachini. Mr. Parachini is as policy analyst at RAND.
Previously he served as executive director of the Washington
office of the Monterry Institute of International Studies and
the Center for Nonproliferation Studies. He is editing a volume
of case studies analyzing terrorist motivations and behavioral
patterns involving the use of radiological, biological and
chemical weapons. Prior to assuming duties at the Monterry
Institute mr. Parachini was a senior associate at the Henry L.
Stimson Center. He has taught at the University of Southern
California and Baruch College of the City University of New
York. He has had short assignments--U.S. State Department's
Operation Center, Bureau of Political-Military Affairs,
Intelligence and Research, and Ocean Sand International
Environmental and Scientific Affairs. He holds an MBA from
Georgetown, an MA from Johns Hopkins and a BA from Haverford
College.
Welcome, Mr. Parachini.
STATEMENT OF JOHN PARACHINI, POLICY ANALYST, RAND WASHINGTON
OFFICE, WASHINGTON, D.C.
Mr. Parachini. Thank you, Madam Chair, for the privilege
and the opportunity to testify on this topic. I, too, would
like to request that my written statement be entered into the
record.
Chairperson Feinstein. So ordered.
Mr. Parachini. I would like to focus on the recent anthrax
attacks as a case study of a paradigm shift, that has occurred
in the whole field of biological weapons terrorism. The
sophisticated quality of the material sent to Senator Daschle
here at the Senate really has called into question assumptions
about three possible perpetrators. Heretofore we have not
thought that states would attack us in peacetime and indeed the
quality of the material that arrived here was of that level--
state-level quality.
Heretofore we have not thought that a state would give this
type of material to a terrorist group or to an individual and
yet that is a possible perpetrator here.
Heretofore we have really not thought that a terrorist
group or an individual could by themselves culture and develop
material of the sophisticated quality that we saw here in the
Senate. So something is happening that is fundamentally
different than it was before these incidents occurred.
They are serious but we should maintain some perspective on
the nature of the threat. They are serious and there has been
some traffic loss of life and indeed some exposures but it does
not compare in any way to what happened on September 11 in
which approximately 5,000 people died in short order. So while
we are troubled by these anthrax attacks, we need to keep in
perspective what did occur on September 11 and how in a very
short period of time terrorists turned an ordinary means of
modern transportation into a fuel-laden cruise missile that
destroyed major buildings, both in New York and over at the
Pentagon.
We have not been able to identify any link between what
happened on September 11 and the anthrax attacks or between the
September 11 terrorists and the Iraqi government but there are
suspicious moments of connection between all three, but I think
at this time with this fundamental shift we ought to keep our
mind open to what the possibilities might be.
The historical record on the use of weapons of mass
destruction for terrorism is remarkably small, given how
vulnerable we are as an open society. So we have to ask
ourselves fortunately, why is that record so small? It is both
small in terms of terrorist use but also in terms of nation
state use. Nation states certainly have the ability to assemble
the people and the industrial capabilities to make these types
of weapons and yet on the battlefield fortunately they are
comparatively small dataset when they have actually been used.
But in the last 15 years there have been some disquieting
developments. There has been a change in how terrorists have
operated. In contrast to the terrorists who used to strike at
symbolic targets and then issue long turgid manifestos
articulating their point of view, we now are in a period in
which terrorists strike indiscriminately and kill lots of
people and never claim credit, or at least never claim credit
until they've been captured, tried and imprisoned.
So are we at a fundamental historical dysjuncture? I think
that is a question we need to ask ourselves. The historical
data suggest that this is comparatively rare that this happens
but indeed there are some disquieting new trends.
I think we want to also bear in mind that while we are
unusually vulnerable and there are capabilities out there and I
thought the questioning with some of the government witnesses
was very revealing about some of the possibilities that are out
there that we should be concerned about, that we need to
balance those concerns about possibilities with what are some
of the obstacles and indeed disincentives for terrorists and
individuals to use these types of weapons. Otherwise it would
be occurring much more often than it is. And perhaps if we
examine in some detail some of the obstacles and disincentives
we can, in a broad effort, try to augment those disincentives
and those obstacles the make it less likely.
We are never going to eliminate the problem of terrorism,
we may never eliminate the problem of proliferation, but we can
certainly narrow the possibilities.
Technical and operational barriers are important and they
have heretofore made a significant difference in the nature of
this threat that we face. We should examine those technical and
operational difficulties in greater detail and try to augment
them.
There also are readily available alternatives,
unfortunately. That is, more terrorists have used explosives,
high explosives, and killed more people than have died in all
of the terrorist attacks using unconventional weapons.
So there are these alternatives that a determined terrorist
will turn to, as opposed to sort of going through the elaborate
process of trying to develop very sophisticated heretofore
thought to be just military-grade weapons.
With biological agents there is not the psychic
gratification of immediate response that the bomber gets.
Biological agents require delayed gratification and there is
not the immediate response; they occur over there. So there may
be a psychic difference here that we ought to understand, as
well.
Finally, the fear or retaliation is something that gives
people pause, even determined killers.
Let me conclude by pointing out that in this new phase
there are some contradictory indications. One is we have seen a
paradigm shift but I think the response of the Congress, the
executive branch, local responders is helpful in showing that
we can manage a limited biological weapons attack. This may
prove in the end that these are not as effective weapons, if
indeed your design is really to kill lots of people. But the
enormous attention on these attacks is likely to stimulate
interest in others so we should proceed with great caution and
great concern.
I think we should reenergize our efforts to find preventive
tools to add to our tool kit to stop the proliferation of these
materials to individuals and subnational groups and indeed
states way out in front, long before they ever come to our
shores.
Finally, it is hard to maintain perspective on relative
dangers in the moment of a crisis but I think that is the
challenge of leadership and that is what we need to do. And on
September 11 lots of people died and the task that we have now
is to address what is a serious biological attack but on a
different scale and magnitude.
Let me conclude there and thank you once again, Madam
Chair, for the opportunity to testify and I look forward to
your questions and the questions of the other senators.
[The prepared statement of Mr. Parachini follows:]
Statement of John Parachini, Policy Analyst, Rand Corporation,
Washington, D.C.
Thank you, Madam Chair, for the privilege and opportunity to
testify before the Subcommittee on Technology, Terrorism and Government
Information. Information about the quality of the anthrax used in the
letter sent to Senator Daschle indicates a potentially significant
paradigm shift in the scope and magnitude of the bioterrorism threat.
My remarks will focus on the potential perpetrator of the recent
anthrax attacks. Examining who is behind these attacks provides a
current case study to review the threat of bioterrorism. In my opinion,
bioterrorism includes any organization, even a state, or individual who
seeks to terrorize, incapacitate or kill with disease and biological
material. In conclusion, I will review some preventive measures that
aim to diminish the proliferation of biological agents to states and
terrorists.
The sophisticated quality of the Anthrax used in the letter sent to
Senator Daschle suggests that the bioterrorism threat has reached a new
level previously viewed by many analysts, myself included, as possible,
but unlikely. At the moment, this new level of threat is manageable,
but we must take into account the profound implications of this shift
if we are to devise effective preventive and protective policies.
There are at least three possible explanations for the origins of
the sophisticated Anthrax contained in the letter sent to Senator
Daschle; all of them have heretofore been considered possible, but
unlikely. First, these attacks could be the clandestine act of a state
either rolling towards wider conflict or secretly inflicting harm
because it believes it can do so without detection and attribution.
Second, a state could have engaged a terrorist group to conduct the
attack or provided the material to a sub-national entity for its own
purposes. Third, a terrorist group or individual could have produced
this sophisticated quality of anthrax itself or received assistance
from scientists willing to sell their expertise. All of these three
explanations represent a break with the historical precedents.
The historical data set of biological weapons use by states or
terrorists, covertly or overtly, is very limited.\1\ Given our
potential vulnerabilities, it is a small wonder that states and
terrorists have not used disease more often. Understanding why the use
of biological weapons has been so infrequent may constructively focus
our examination of the current anthrax attacks on measures to reduce
the possibility of other attacks in the future.
---------------------------------------------------------------------------
\1\ For an insightful discussion of the history of weapons of mass
destruction and their use by states and terrorists see, David Rapoport,
``Terrorism and Weapons of the Apocalypse,'' National Security Studies
Quarterly, Vol. V, No. 3, (Summer).
---------------------------------------------------------------------------
State Perpetrated Bioterrorism
When it comes to the feasibility of using biological weapons,
states are most likely to have the resources, technical capabilities,
and organizational capacity to assemble the people, know-how, material,
and equipment to produce such weapons and to be able to clandestinely
deliver them to valued targets. Mustering the resources and
capabilities to inflict a devastating blow with biological agents has
proven to be a formidable task even for states.
The quality of the anthrax sent to the U.S. Senate reportedly has
characteristics generally associated with state biological weapons
programs. Clandestine use of a biological agent by a state against the
United States has traditionally been viewed as highly unlikely. Fear of
devastating retaliation is generally believed to deter states from
conducting such attacks. Retaliation would potentially be devastating
because some uses of some biological agents can serve as strategic
weapons. For example, wide dispersal of anthrax that could be
aerosolized or strategic distribution of an infectious agent such as
smallpox or plague could produce significant casualties and greatly
disrupt life in America. Conventional wisdom is that states might use a
biological weapon like anthrax as a weapon, but only as a last resort.
The United States and the former Soviet Union dedicated
considerable national defense resources to their biological weapons
programs, and both countries encoutered significant difficulties along
the way. Iraq also dedicated considerable resources to its biological
weapons program; although Iraq's effort was more successful than most
experts imagined possible, it still encountered a number of significant
challenges. A state's ability to command resources and organize them
for certain priority scientific and industrial objectives presents the
potential for the greatest threat of bioterrorism. Given advances in
biological sciences and the plethora of information made public about
biological weapons in the last five years, other countries may have
learned how to produce Anthrax with sophisticated properties.
However, there are three circumstances when a state might
clandestinely wage biological terrorism. First, a state struggling for
its existence might be willing to use biological weapons clandestinely
as a means to forestall or to prevent imminent defeat. There is no
historical example of a state responding with a biological weapon in a
moment of desperate struggle for its existence, but it is conceivable.
While the Taliban government of Afghanistan might be an example of
a government in danger of being eliminated, the anthrax attacks started
before the United States commenced military operations. Even the logic
that a desperate government such as the Taliban or Iraq's Saddam
Hussein might lash out against the United States as a desperate move
seems improbable. The best the clandestine state attacker could hope
for would be to inflict a large number of casualties and to avoid
discovery. A successful state biological weapons strike, clandestinely
delivered against the United States, might cause many casualties, but
it would not lead to the end of the American form of government or
ensure the conquest of American territory. Short of a barrage attack of
ballistic missiles, the U.S.'s ability to reconstitute itself remains
robust. Even a significant clandestine biological strike on a major
city would not topple the system of government in the United States.
Thus, the inherent limits of hiding a significant attack constrain the
realm of the possible.
Second, if a state felt it could attack with biological weapons and
be undetected, it might do so. In the twentieth century, there are only
two significant examples of states using biological agents
clandestinely except during times of war. For example, in the First
World War, Germany sought to disrupt allied logistical capabilities by
infecting horses with glanders.\2\ The other case involves Japanese use
of biological agents during its occupation of China. Only during
wartime have states conducted indiscriminate attacks with biological
weapons. In the few instances, the attacked state did not have the
ability to respond with devastating force. Given the long and powerful
reach of modern states, it is hard to imagine a state risking the
political and military consequences of discovery.
---------------------------------------------------------------------------
\2\ Mark Wheelis, ``Biological sabotage in World War I,'' in
Biological and Toxin Weapons: Research, Development and Use from the
Middle Ages to 1945, Edited by Erhard Geissler and John Ellis van
Courtland Moon, SIPRI Chemical & Biological Warfare Studies NO. 18,
(Oxford, UK: Oxford University Press), pp. 35-61.
---------------------------------------------------------------------------
A third situation when a state might engage in biological terrorism
would be if it attacked its own citizens. In the 1980s, both the
Bulgarian and the South African governments used biological materials
to kill domestic political opponents. South Africa had a significant
clandestine chemical and biological program that supported a major
effort against regime opponents. Little is known about the Bulgarian
program, but government operatives are believed to have assassinated a
Bulgarian dissident in London with the toxin ricin, which they received
from the Soviet KGB. Both of these cases entailed discriminate uses of
biological weapons. Aside from state assassinations of regime
opponents, states have been extremely reluctant to use biological
weapons.
If the current anthrax attacks are the work of a state, this
suggests that states might use biological weapons for non-strategic
purposes. That is, the current anthrax attacks could be the work of a
state that wished to inflict revenge on the United States. The state
would not seek to conquer the territory of the United States or end the
American system of government. The Iraqi government is one that comes
readily to mind as a state that might have this motive. The United
States defeated Iraq in military battle and killed many of its military
personnel and civilians. But this is a theoretical explanation. Yet, at
the moment, there is no evidence positively linking Iraq to the spate
of attacks.
Other than the quality of the anthrax sent to the U.S. Senate and
inferences one might draw about grievances other states hold against
the United States, there is no evidence at the moment that a state is
the perpetrator. It is imaginable that we are at the start of a war and
another state is clandestinely attacking with anthrax as a diversion.
Similarly, it is imaginable that the state perpetrating these attacks
is willing to take great risks. And finally, it is imaginable, that a
state is attacking the United States with anthrax as a trial to see how
we respond. All of these scenarios are possible, but there is no
evidence supporting them at the moment. Until additional evidence
becomes available, state conduct of these attacks is highly unlikely.
While states can amass the resources and capabilities to wage
biological terrorism, considerable disincentives keep them from doing
so. A state that undertakes a clandestine attack using biological
weapons risks the prospect of the attack being traced back to them. The
response to an attack with biological weapons could be devastating,
which gives states reason for caution.
State Assistance to Sub-National Entity
An alternative possibility is that a state has provided this
sophisticated anthrax to a terrorist group. The terrorist group is
either serving as a surrogate for a state or a state is transferring
biological weapons to a terrorist group for its own purposes. Both
possibilities have heretofore been viewed as unlikely.
There are no widely agreed upon historical examples in the open
source literature of states providing sub-national groups with
biological weapons for overt or covert use. Money, arms, logistical
support, training, and even training on how to operate in a chemically
contaminated environment are all forms of assistance states have
provided to terrorists. But historically they have not crossed the
threshold and provided biological weapons materials to insurgency
groups or terrorist organizations. State sponsors have a great
incentive to control the activities of the groups they support, because
they fear that retaliation may be directed against them if they are
connected to a group that used biological weapons. Even if states
sought to perpetrate biological attacks for their own purposes, they
would probably not trust such an operation to groups or individuals
that they do not completely control.
Some argue that Saddam Hussein's Iraq is the type of state that
might cross this threshold.\3\ In the case of Iraq, the leadership
would probably make the decision to undertake such a risky operation.
In most countries in an adversary relationship with the U.S. what is
more likely than a conscious decision by a country's command authority
is that an unauthorized faction within a state might take it upon
itself to use a sub-national group to do its dirty work. The alleged
involvement of the Iranian government security services in the attack
on American military personnel in Khobar Towers seems to be an example
of this type of involvement. Thus, while the probability of states
using sub-national groups or individuals to perpetrate a biological
warfare attack on its behalf seems low, it is not zero.
---------------------------------------------------------------------------
\3\ Laurie Myroie, Study of Revenge: Saddam Hussein's Unfinished
Ware against America, (Washington, DC: The AEI Press), 2000. See also
Laurie Myroie, ``The Iraqi Connection'', The Wall Street Journal,
September 13, 2001, p. A20. For an alternative view of Iraqi
involvement in the 1993 bombing see John Parachini, ``The World Trade
Center Bombers (1993),'' in Jonathan B. Tucker, ed., Terror: Assessing
Terrorist Use of Chemical and Biological Weapons, (Cambridge,
Massachusetts: MIT Press, 2000).
---------------------------------------------------------------------------
Meetings between some of the September 11th terrorists and Iraqi
intelligence operatives raise the questions whether Iraq or a faction
within the Iraqi intelligence service is involved. Thus far, there is
no publicly available evidence linking Iraq to the September 11th
terrorists or linking the September 11th terrorists to the anthrax
attacks. However, the contact between the Iraqis and the terrorists is
suspicious. Ongoing U.S. enforcement of no-fly zone in northern and
southern Iraq may cause Saddam Hussein to view his state in perpetual
war with America. Given the dictatorial fashion in which Hussein rules
the country, it is hard to imagine a rogue element within the Iraqi
government acting without his knowledge and approval. Furthermore, the
enforcement of the no-fly zones does not present an imminent challenge
to the survival of the Iraqi regime. Thus, until new evidence becomes
available, the contacts and the timing of the anthrax attacks remain
suspicious, but provide no smoking gun.
Sub-National Entity Perpetrates Bioterrorism
Sub-national groups or individuals can develop or acquire their own
biological weapons capabilities for clandestine use, but it is not
easy. Terrorist groups and individuals historically have not employed
biological weapons because of a combination of formidable barriers to
acquisition and use and comparatively readily available alternatives
and disincentives. Procurement of materials and recruitment of people
with skills and know-how are formidable barriers. Even if some of the
materials and production equipment are procurable for legitimate
scientific or industrial purposes, handling virulent biological
materials and fashioning them into weapons capable of producing mass
casualties is beyond the reach of most sub-national groups or
individuals.
In the last twenty years, there are only two significant cases of
sub-national groups using or attempting to use biological weapons and a
few cases where groups or individuals made efforts to acquire
biological materials. In 1984, the Rajneeshees, a religious cult group
located in Oregon, sought to win a local election by running its own
candidates and intentionally poisoning local townspeople who they
expected would vote against them.\4\ Using their medical clinics, cult
members ordered a variety of bacterial cultures from the American Type
Culture Collection located in Maryland. They contaminated ten salad
bars with a strain of salmonella, sickening at leat 751 people. They
used commercially available biological agents to incapacitate people
clandestinely, because it was important for them to avoid attracting
attention. The intentional character of the outbreak was not recognized
for over a year, when members of the cult revealed details about the
attacks to authorities in exchange for lighter sentences stemming from
other charges.
---------------------------------------------------------------------------
\4\ W. Seth Carus, ``The ajneeshees (1984),'' pp. 115-137, in
Jonathan B. Tucker, ed., Toxic Terror: Assessing Terrorist Use of
Chemcial and Biological Weapons, (Cambridge, Massachusetts: MIT Press,
2000). See also, Judith Miller, Stephen Engelberg, William Broad,
Germs: Biological Weapons and America's Secret War, (New York, NY:
Simon & Shuster), pp. 15-33.
---------------------------------------------------------------------------
The other case occurred more than ten years later, when another
religious cult, a Japanese group called the Aum Shinrikyo, sought to
develop and deliver biological agents against a number of targets. The
Aum's unsuccessful attempts at biological terrorism came to light after
it released liquid sarin on the Tokyo subway.
The cult's leader Shoko Asahara wrote songs about sarin. In
addition to this pernicious obsession, Aum leaders had delusions of
grandeur that far exceeded reality. They imagined a world they sought
to create that was not constrained by the world in which they lived. To
bring this imaginary world into being, they sought weapons they
believed might trigger an apocalypse from which they would emerge as a
dominant power. Aum leaders may have deluded themselves into thinking
that their organization was a government and military-in-waiting, and
hence, seeking to acquire weapons it believed states possessed seemed
legitimate. Instead of seeking lower-grade pathogens, Aum sought
pathogens that are generally associated with military biological
weapons programs. Aum exhibited this unique combination of obsession,
delusions of grandeur, and belief in an apocalypse they could launch
that would enable them to reign like leaders of a state.
In the years since the attack, fears that the Aum attempt to
acquire and use biological weapons heralded a new age in such terrorism
have been a constant refrain. Yet so much about the Aum is so unique
that it is hard to imagine it ever being repeated. Japanese law
enforcement authorities tend to make arrests only when they have an
ironclad case against the perpetator of a crime. There were several
incidents prior to the March 1995 sarin attack on the Tokyo subway that
in retrospect should have raised suspicion. Additionally, Japanese
legal provisions protecting religious organizations from intense
government scrutiny inhibited authorities from intervening until long
after the group committed a number of heinous acts. The Aum leadership
presents another anomaly. Shoko Asahara, Aum's leader, was a
controlling leader with an obsession with poisons. He wrote songs in
praise of sarin. He also greatly admired another mass poisoner, Adolph
Hitler. The leadership mindset of Aum explains a great deal about the
group's use of unconventional weapons. They were fascinated by the
means to catalyzing an apocalypse more than they were fascinated by
killing large numbers of people. In contrast, Timothy McVeigh, Ramzi
Yousef, and Mohammed Atta were determined to kill large numbers of
people and the means to do so was merely instrumental.
Two aspects of the Aum biological weapons experience deserve
special note when considering the threat of biological terrorism. Aum's
global effort to procure biological materials for its nefarious
purposes deserves much greater examination. While there is no open
source information indicating that the Aum obtained any radiological,
biological, or chemical materials in Russia, it certainly tried. That
the group tried and succeeded in getting meetings with Russian
scientists, some of whom had weapons expertise, is troubling.
Aum members also traveled to Zaire believing they could obtain
samples of the Ebola virus. There is no evidence to indicate that they
were successful in their venture. What may have inspired their trip was
a newspaper account of a Japanese tourist who developed a hemorrhagic
fever after returning from a game safari in Africa. In fact, during
period when Aum members traveled to Zaire there were no reported
outbreaks of Ebola. Aum was trying to obtain biological material from
infected people or corpses fo weapons purposes. This highlights a very
different source of material than the weapons laboratories of the
former Soviet Union. It is probably easier to monitor scientific
institutes that were once or are currently affiliated with weapons
programs than it is to monitor the sites of deadly disease outbreaks
that occur around the globe. Some thought and attention needs to be
given to how natural disease outbreaks might be exploited for
pernicious purposes.
Bioterrorism in Context
While recent reports do suggest that we need to adjust our
perspective of the bioterrorism threat, we should not lose sight of the
scope and magnitude of the tragic events on September 11th and a number
of other mass casualty terrorist attacks in the 1990s that involved
conventional explosives, not nuclear, biological or chemical weapons.
Amidst the evolving bioterrorism threat it is difficult to keep
perspective on the relative dangers different terrorist attacks pose.
Critical to our thwarting the designs of the perpetrator of the anthrax
attacks and succeeding in the campaign of civilized society against
barbarism is putting dangers into perspective and calibrating our
actions accordingly.
In these uncertain times, it is important to maintain some
perspective of the relative dangers. Despite the recent anthrax
attacks, the history of biological warfare, terrorism, and crime is
still much less deadly than that of the history with conventional
explosives. While history is not a perfect guide to the future, it does
provide a context for our thinking.
Since the future is impossible to see clearly, we must anticipate a
number of possible scenarios. We need to take account of history and
hedge against imponderables of the future. Although the prospects of a
major biological terrorist attack are remote, small-scale biological
attacks are much more likely. In this light, the challenge before the
government is how to put relative dangers in proper perspective and yet
still hedge against future eventuaities that are unlikely, but
possible.
Why has BW use Been so Infrequent?
The use of disease and biological material as a weapon is not a new
method of warfare. What is surprising is how infrequently it is has
been used. Biological agents may appeal to the new terrorist groups
because they affect people indiscriminately and unnoticed, thereby
sowing panic. A pattern is emerging that terrorists who perpetrate mass
and indiscriminate attacks do not claim responsibility.\5\ In contrast
to the turgid manifestos issued by terrorists in the 1960s, 1970s and
1980s, recent mass casualty terrorists have not claimed responsibility
until they were imprisoned. Biological agents enable terrorists to
preserve their anonymity because of their delayed impact and can be
confused with natural disease outbreaks. Instead of the immediate
gratification of seeing an explosion or the glory of claiming credit
for disrupting society, the biological weapons terrorist may derive
satisfaction from seeing society's panicked response to their actions.
If this is the case, this is a new motive for the mass casualty
terrorist.
---------------------------------------------------------------------------
\5\ Bruce Hoffman ``Why Terrorists Don't Claim Credit,'' Terrorism
and Political Violence, Vol. 9, 1 (Spring 1997), pp. 1-6.
---------------------------------------------------------------------------
There are a number of countervailing disincentives for states and
terrorists to use biological weapons, which help explain why their use
is so infrequent. The technical and operational challenges biological
weapons pose are considerable. Acquiring the material, skills of
production, knowledge of weaponization, and successfully delivering the
weapon, to the target is difficult. In cases where the populations of
the terrorist supporters and adversaries are mixed, biological weapons
risk inadvertently hitting the same people for whom terrorists claim to
fight. Terrorists may also hesitate in using biological weapons
specifically because breaking the taboo on their use may evoke
considerable retaliation. The use of disease as a weapon is widely
recognized in most cultures as a means of killing that is beyond the
bounds of a civilized society.
From a psychological perspective, terrorsts may be drawn to
explosives as arsonists are drawn to fire. The immediate gratification
of explosives and the thrill of the blast may meet a psychological need
of terrorists that the delayed effects of biological weapons do not.
Causing slow death of others may not offer the same psychic thrill
achieved by killing with firearms or explosives.
Perhaps the greatest alternative to using biological weapons is
that terrorists can inflict (and have inflicted) many more fatalities
and casualties with conventional explosives than with unconventional
weapons. Biological weapons present technical and operational
challenges that determined killers may not have the patience to
overcome or they may simply concentrate their efforts on more readily
available alternatives.
Putting aside the spectacular quality of the Aum subway attack with
liquid sarin, far fewer people died or were injured than in similarly
spectacular attacks with explosives. In comparison to the bombings of
the Murrah federal building in Oklahoma City, the Khobar Towers
military barracks in Saudi Arabia, and the U.S. embassies in Kenya and
Tanzania, fewer people died as a result of the sarin release. In
comparison with the recent attacks on the World Trade Center and the
Pentagon, the Tokyo subway incident, though clearly tragic, was simply
an event of much smaller scale.
But even if the possibility of a catastrophic biological weapons
attack is remote, government has a responsibility to do all that it can
to prevent, protect against, and respond to events that seem unlikely.
The challenge is to determine how much to prepare for a low-
probability, albeit potentially catastrophic attack, while at the same
time, guarding against not focusing enough on more probable events with
significant, but not necessarily catastrophic, consequences.
Nonproliferation Measures to Address Biological Terrorism
The recent anthrax attacks highlight a number of improvements the
United States needs to undertake in order to better prtect its
citizenry against bioterrorism. The positive side of these frightening
attacks is that they are forcing an upgrade of our capabilities to
handle bioterrorism. I will focus most of my remarks on some long-term
preventive tools. In the fight against bioterrorism, a full set of
tools will be needed because there are no silver bullet solutions to
the threat. The tools I discuss below complement others in the fields
of intelligence, law enforcement, counter-proliferation, medical
diagnostics and forensics, and disease surveillance, to name just a
few.
Preventive nonproliferation measures can form the basis for a
frontline of defense against attacks with biological weapons. After
attack response is important because it can help limit the loss of
life, destruction of property and political implications of an attack.
However, after attack measures are not a substitute for preventive and
preemptive measures. Completely eliminating the possibility of an
attack with unconventional weapons is probably not possible, but
reducing the opportunity for states and sub-national groups to acquired
unconventional weapons is possible.
The United States rejected the text resulting from several years of
negotiations toward a draft protocol to the Biological Weapons
Convention (BWC) as unsatisfactory for the task: preventing the
proliferation of biological weapons.\6\ The challenge for the Bush
administration is to reinforce the normative prohibition against
biological inscribed in the BWC and at the same time propose measures
that genuinely strike at the long-term problem of biological weapons
proliferation to states and sub-national entities.
---------------------------------------------------------------------------
\6\ Statement by Ambassador Donald Mahley to the Ad Hoc Group of
Biological Weapons Convention State Parties, July 25, 2001.
---------------------------------------------------------------------------
States trying to strengthen the BWC will meet this month, and the
Bush administration will need to describe measures that the
international community should consider to counter the biological
weapons proliferation problem. Given the events in the United States,
the timing of a constructive international discussion could not be
better.
There are three ools the international community should consider
that address the problem of biological weapons that could form the
basis for a new international approach to biological weapons
proliferation. One portion of the rejected draft protocol that warrants
consideration outside the context of the negotiations is the guidance
on investigations of unusual outbreaks of disease.\7\ Early detection
of unusual outbreaks of disease, rapid communication of a diagnosis,
communication of the diagnosis to public health authorities and
delivery of appropriate antibiotics, can save many lives and turn a
potentially large outbreak into a manageable incident.\8\
---------------------------------------------------------------------------
\7\ Michael Moodie, ``The BWC Protocol: A Critique,'' CBACI Special
Report1, June 2001, pp. 28-29.
\8\ Jonathan B. Tucker, Testimony before the Subcommittee on Labor,
Helath and Human Services, Education, and Relation Agencies of the U.S.
Senate Committee on Appropriations, Improving Infections Disease
Surveillance to Combat Bioterrorism and Natural Emerging Infections,
October 3, 2001, (http://www.cns.miss.edu/research/cbw/testtuck.htm)
(Viewed on October 9, 2001).
---------------------------------------------------------------------------
These investigations do not necessarily require a new international
agency like a Biological Weapons Convention Organization (BWCO). The
Conventional Forces in Europe (CFE) treaty provides one example of how
a grouping of states could investigate agreed upon problems such as
suspicious outbreaks. The findings of experts from regional groupings
of states could be reported to the UN Security Council, the World
Health Organization, an existing multilateral security organization in
the region of the outbreak, and the individual states in the region of
the outbreak.
Another option is described in a UN General Assembly mandate
providing the UN Secretary General with powers to investigate alleged
use of chemical and biological weapons. This provision permits the UN
Secretary General to dispatch a group of qualified experts to conduct
an investigation and report back to the General Secretariat or the UN
Security Council. This model was outlined in the UN General Assembly
under its resolution 42/37C in November 1988.\9\ In October 1989 a
group of experts provided a report on how investigations of alleged use
might be conducted. Even if these investigations do not discover
clandestine weapons programs, they will make a contribution to
international public health. Enhanced monitoring of global disease
outbreaks provides both a public health benefit and a security benefit
Thus, for every dollar or yen invested, there is a clear public health
benefit and a potential security benefit.
---------------------------------------------------------------------------
\9\ Draft Report of the World Health Organization on Chemical and
Biological Weapons.
---------------------------------------------------------------------------
A new global effort must be made to stop the proliferation of
dangerous pathogens to irresponsible states, organization and
individuals. There are almost 100 culture collections in the United
States and more than 450 collections around the world. The U.S.
improved its system in 1995 after an individual with ties to anti-
government groups fraudulently sought disease cultures from a culture
collection, but it still may require further improvements.\10\ A
national baseline of where dangerous pathogens are currently located
needs to be established. Additionally, a national registry should be
established that lists all the scientists who are working with such
pathogens. It is frightening to note what little regulation other
countries have governing the transfer, storage, and use of dangerous
pathogens.
---------------------------------------------------------------------------
\10\ Jessica Eve Stern, ``Larry Wayne Harris,'' in Jonathan B.
Tucker (ed.), Toxic Terror: Assessing Terrorist Use of Chemical and
Biological Weapons, (Cambridge, Massachusetts: MIT Press, 2000)
---------------------------------------------------------------------------
The international community must strive to strike a balance between
pathogen commerce for legitimate commercial and scientific purposes and
preventing the transfer of deadly materials to people who will use them
as weapons. The combination of national export controls and the
Australia Group coordination is simply not sufficient for regulating
commerce in pathogen samples. Many countries with culture collection do
not participate in the Australia Group. Similarly, national laws
governing exports of biological materials vary tremendous from country
to country, and not all of them meet model international standards. New
standards that are more universal in character and more appropriate to
the commodity in question are needed.
Finally, the current international legal regime system is
inadequate for the current crisis in part because it focuses on the
activities of states and not sub-national groups. While the Chemical
Weapons Convention (CWC) does require each state party to pass and to
implement national legislation penalizing individuals and companies
that violate the provision that apply to the state, many countries
remain in technical violation of this requirement. Less than half of
the CWC state parties have drafted implementing legislation, which is a
troubling example of technical non-compliance.\11\ Additionally, among
the countries that have enacted legislation, the issue of penal
legislation has been inadequately addressed. The international
community must urge CWC state parties to pass the required domestic
legislation. This is one of those small, but important aspects of
treaty implementation that the international community has not
adequately addressed in an era when there is more attention paid to
negotiations.
---------------------------------------------------------------------------
\11\ Barry Kellman, ``National Legislation to Implement Leagal
Assistance and Cooperation, International Symposium: Cooperation and
Legal Assistance for the Effective IMplementation of International
Agreements, The Hague, Netherlands, February, 2001. See also, Barry
Kellman, ``WMD Proliferation: AN International Crime? The
Nonproliferation Review, vol. 8, no. 2, Summer 2001.
---------------------------------------------------------------------------
The Harvard Sussex Program on CBW Armament and Arms Limitation has
proposed an international accord criminalizing possession, transfer and
use of chemical and biological weapons by individuals. In essence, this
draft convention provides the international legal framework to
prosecute anyone, from the terrorist to the head of state, who uses
chemical or biological weapons. The initiative seeks to fill a gap in
existing international legal framework.
As the international community considers this valuable stopgap
measure it also needs to consider how to ensure effective
implementation. National governments need to provide adequate financial
and law enforcement resources to make this convention meaningful. More
treaties need to be complemented by the law enforcement capabilities
sufficient to apprehend chemical and biological weapons terrorists and
the political will to prosecute them to the fullest extent. Far too
often the international community and national government bless
unfunded mandates and expect results.
Conclusion
The recent anthrax attacks represent a fundamental shift in the
nature of the biological terrorism threat. Fortunately, the scope and
magnitude of this shift is far less devastating than the events of
September 11th. As we face this new phase of biological weapons
terrorism, it is important to maintain perspetive even though the
ability of the perpetrator of the anthrax attacks to terrorize the
country is distressing. Fortunately, there have been comparatively few
casualties. These attacks should serve to spur government action on a
number of fronts to strengthen our national ability to prevent the
proliferation of biological weapons, deny and dissuade states and sub-
national groups from using them, and develop rapid means to detect an
attack and track down the perpetrator should preemptive and preventive
measures fail.
Chairperson Feinstein. Thank you very much. I appreciate
this. Thank you.
I have in front of me a current CDC list of biological
pathogens, viruses, bacteria, fungi and toxins and there are
about 40 of them and I am just reading what they do and they
are absolutely devastating.
Mr. Atlas, let me begin with you. In your estimation how
many labs in the United States currently possess or work with
these select biological agents?
Mr. Atlas. I guess the answer to that is probably a few
hundred, 250 plus laboratories. That is based on a survey that
we did at the University of Louisville under subcontract from
the Department of Energy where we surveyed all universities in
the United States, all 2,500 institutions, and came up with
that sort of estimate in terms of universities anyway having
select agents.
Chairperson Feinstein. And they would work with one or some
of this list of 40?
Mr. Atlas. That is correct, one or some. We have gone back,
Madam Chairman, and looked at anthrax in particular and the
estimate there is probably 20 to 30 laboratories having anthrax
at universities, not necessarily all having virulent forms.
Some could be vaccine strains. We did not differentiate between
whether it was a pathogen or not. In fact, the CDC list, unless
it is a licensed vaccine, does not differentiate between the
real disease-causing forms and those that are not capable of
causing disease. The only exemptions in that shipment list are
for the strains of particular organisms like the bacterium that
causes anthrax if it is licensed as a vaccine.
Chairperson Feinstein. What is the significance of that?
Mr. Atlas. It means that of the numbers I am giving you, in
fact, fewer labs probably have virulent strains, those strains
of these agents that could cause disease or be used by
bioterrorists.
Chairperson Feinstein. Okay. Do you believe that anyone not
affiliated with a legitimate health or research institution
should be able to possess his or her own personal supply of
anthrax?
Mr. Atlas. Absolutely not. These agents should be
restricted to legitimate facilities and the workers there must
be pursuing research or diagnostic activities that are for the
public good.
Chairperson Feinstein. Well, I strongly agree with you.
Then why do universities oppose this? Why is there this--it is
all sub rosa but as soon as you begin to surface with really a
strict certification system and make possession of these death-
producing toxins illegal, there is a reaction to it. I do not
understand it because I do not understand why anybody should
have to have these things unless you are part of a legitimate
certified research lab.
Mr. Atlas. I agree with you that the ASM has agreed with
that basic tenet. I think there is a sense, in part among
universities, of regulations, of how we are able to deal with
regulations that will cause some heartburn for some
administrators. But there also has been some concern that we
could cause people to destroy legitimate cultures, that
legitimate researchers would walk away. I think as long as--
Chairperson Feinstein. Well, what is wrong with that? If
all these things produce death and can be misused, why would we
worry if they destroyed them?
Mr. Atlas. Because we need the researchers to find the
vaccines and the pharmaceuticals. If we destroy the cultures
and we do not have legitimate researchers doing research on
anthrax, we will not have the drugs and the vaccines in future
to combat any bioterrorist attack. Much of that research goes
on at our universities, as well as in the federal labs and
other industrial laboratories. That is absolutely critical to
the welfare of the nation.
Chairperson Feinstein. Is the toxin or the virus or the
pathogen in the possession of the individual or the lab when
you work for a lab?
Mr. Atlas. I think it ought to be in the possession of the
laboratory and then we need to look at who has access to that
within the laboratory, but it never should be removed from that
laboratory setting. It is in that setting where the appropriate
biosafety and biosecurity measures are in place and where the
CDC can and should oversee them.
Chairperson Feinstein. And today they are removed from the
lab.
Mr. Atlas. Not that I know of. I mean obviously someone has
taken an agent now from somewhere and spread it but to my
knowledge, legitimate researchers do not take these agents
home, they do not remove them from the laboratory setting. They
should not endanger the public that way.
Chairperson Feinstein. The USA Patriot Act signed into law
by President Bush prohibits certain restricted individuals,
such as dishonorably discharged veterans, felons, fugitives,
illegal aliens and drug users, from possessing or transferring
any select agents. Do you believe these restrictions are
appropriate? Are there any classes of individuals who should be
on the restricted list who are not?
Mr. Atlas. I think we think that that list is appropriate.
I think, as I indicated in the testimony, the only thing that
we might have liked to have seen was the authority resting with
the attorney general to grant an exemption if it was in the
national interest.
Chairperson Feinstein. Let me just be clear. The attorney
would essentially have a waiver of these things and be able to
give a prior felon--
Mr. Atlas. The recommendation of the ASM as this was being
developed was that the secretary of HHS be able to make a
recommendation to the attorney general on an individual basis
to grant an exemption if indeed it was in the interest of the
United States to have such an individual have possession.
Now that may never have occurred but we do think that at
that level it is appropriate for government officials to be
able to say we need an expert. Let us say that we had someone
come from Iraq who could provide expertise who currently would
be, under the USA Patriot Act, excluded. If the secretary of
HHS and attorney general said we really need this person, we
think we should provide that ability.
Chairperson Feinstein. All right. My red light is on but in
the next round I do want to ask you about the current
registration requirements. So I will defer to Senator Kyl.
Senator Kyl. Thank you.
Dr. Atlas, you testified there are about 250 university
labs that would have access to these materials but you were not
identifying the number of nonuniversity labs. Is that correct?
Mr. Atlas. That is correct. We did not do our own survey of
that. There have been publications from the--
Senator Kyl. Do you have any estimate based on other
publications about how many other labs might also--
Mr. Atlas. The total number that we have seen in the
literature is about 550 within the United States.
Senator Kyl. Thank you.
Chairperson Feinstein. In addition to 250?
Mr. Atlas. No, a total of 550.
Senator Kyl. Half university.
Mr. Atlas. Mm-hmm.
Senator Kyl. Now with respect to the equipment, let me just
understand how sophisticated this equipment has to be. Let us
take the kind of anthrax spores that were mailed in the Daschle
letter because there is at least some information about the
quality of those spores. Can you give us some sense of the kind
of equipment that would be necessary to produce that and how
ubiquitous that equipment might be and how sophisticated it
might be and whether there is any point in trying to regulate
somehow the possession of that particular equipment?
Mr. Atlas. Let me divide that into two, part of which I can
answer. It is easy to grow the organism. It is easy to isolate
the organism even from nature if we do not get it from a
laboratory, and that equipment is very widely dispersed. I
could not begin to count how many laboratories have that
capability and how many of us who have been trained as
microbiologists have the expertise to isolate and grow up to a
point where you could create a biocrime but not the
bioterrorist sort of event that we are seeing.
Beyond that, frankly I cannot answer the question because I
do not have the knowledge of how to go from that state to
creating a true bioweapon, as has been described as the spores
in the Daschle letter. That is more an engineering phenomenon
of milling or other technology to bring it into a form where
the electrostatic charges have been diminished where it can
become aerosolized.
So not knowing that step, I cannot answer the question as
to how many individuals would have that. Given the ubiquity of
the microbiological side of the equipment, if I was going to
look at equipment to regulate I would look at that engineering
side of the milling equipment and that has sort of been also
discussions that I have had in negotiations on the Biological
Weapons Convention, where equipment has been at the fore of
what we might, in fact, look at.
Senator Kyl. We will need to define more precisely if we
are going to identify any equipment what that might be and I
look forward to working with you.
I have a question for you, Mr. Parachini, but do you have
any addition to that last question?
Mr. Parachini. I guess the only thing that I would add, and
I know the scope of the jurisdiction of this Committee is
largely domestic, but we should also keep in mind that there
are lots of foreign universities and laboratories. We should
get a handle on our own problem first but we should be aware
that other places there is not near the accountability as we
have in this country and this problem may be global in scope.
Indeed the Ames strain of anthrax has been sent around the
world for years.
So even if we get our own house in order, which is not an
easy task, we have another sort of circle of challenge before
us.
Senator Kyl. Excellent point.
Now in the introduction of your background there was
mention of your work in radiological as well as biological
threats. Could you comment on, discussing this new paradigm,
how you would fold in the radiological threat with the kind of
legislation that you hear us talking about here today or
anything else that you would recommend? And by this I am
distinguishing between the nuclear weapon and the infusion of
radiation-producing materials into some other kind of weapon
which could then disperse them in a widespread way.
Mr. Parachini. I think your line of questioning, Senator,
is very good. I think we have focussed too much in the last six
years on weapons-grade or military-like weapons falling into
the hands of terrorists. That is important and a concern but
the probability of that is low, albeit the consequences could
be quite high but the probability is low. What is much more
likely is industrial chemicals and hazardous waste being used
inventively as weapons because they are much more present and
the regulations on them are not near that which there are on
nuclear power plants or indeed on nuclear weapons.
So much more attention needs to be paid to this more
readily available material that could be used as a weapon.
After all, we saw a group of people turn a passenger aircraft
into an incredible weapon. It is not that difficult to go the
next step and turn a truck of hazardous waste that are being
shipped around for legitimate industrial purposes all the time
in our country, turning that into a weapon, as well.
Senator Kyl. Well, do any of you have a comment
specifically with respect to radioactive materials that could
be used in this fashion? I mean we can talk to other people
about that. I just wanted to see if any of you did.
[No response.]
Senator Kyl. Okay, that is fine. We appreciate very much
the expertise that you have brought to bear here and as we
develop legislation we will want to make sure that we cover all
of the bases in terms of registration, certification that is
required but also realize there are some new trends taking
place and the bad guys will not follow the law and therefore to
balance the legitimate needs of science, the realization that
there are certain kinds of people who, however finely we draft
this, are not going to comply and therefore try to balance the
way that we legislate in a way that will do the most good to
protect our people and do the least damage to the scientific
inquiry that we all support.
Thank you, Madam Chairman.
Chairperson Feinstein. Thanks, Senator Kyl.
Senator McConnell?
Senator McConnell. Thank you, Madam Chairman.
Dr. Atlas, did I hear you correctly in response to one of
Senator Kyl's questions that it is beyond your area of
expertise to know whether there is equipment that is specific
to the production and so-called weaponization of biological
agents?
Mr. Atlas. Yes, that is correct. I think that goes outside
of the realm of microbiology. Microbiologists would take
something to a point but then at least my understanding of how
one would weaponize anthrax spores, it is more an engineering
feat of getting the right particle size in the 2-micron range,
the uniformity, the charges. It is not something that we train
microbiologists to do or that I would know how to do.
Senator McConnell. Well, assuming there is somebody out
there who could answer that question, which we may need
answered in order to decide what, if anything, to regulate in
order to reduce the threat of bioterrorism, that is a question
we do need answered by someone, right?
Mr. Atlas. I would think that one would turn to USAMRID,
who had experience with the U.S. military operation prior to
1969, who has a great understanding of what is, in fact,
required to go from having spores to having a weaponized type
of spore.
Senator McConnell. We spent a lot of time discussing the
measures that Congress ought to take to safeguard U.S. labs
from potential terrorists. Obviously all of our best efforts
might be moot if would-be terrorists are able to acquire
biological agents overseas. As we move forward with these
legislative initiatives, what in your judgment should we be
doing internationally?
Mr. Atlas. I think we have to work for an international
agreement that would criminalize bioterrorism. A number of
members of the scientific community have posed such an act. We
also need to harmonize the rules by which agents are exchanged
and maintained. It does us, I think, little good to know who
possesses agents within the United States if we do not
similarly know who possesses those agents around the world. It
does not do us a lot of good to tighten our national
regulations over the exchange or possession of agents if one
can go to another country and simply obtain them.
Senator McConnell. You estimated there were 500 or so labs
in this country. I gather we have no idea how many there might
be worldwide?
Mr. Atlas. Somewhere probably 1,250, 1,500 labs around the
world would possess the select agents. It is a crude estimate.
Senator McConnell. Beyond the 500 or including the 500?
Mr. Atlas. Including the 500. So 1,000 outside of the
United States would be a quick estimate of that but that is a
lot of places then who are not following the rules that we
currently do under CDC shipment regulations.
Senator McConnell. How might the various legislative
initiatives we are considering here to control access to
dangerous pathogens impact different types of laboratories? I
think you touched on that earlier but specifically how might
they impact clinical laboratories, for example, differently
from research laboratories?
Mr. Atlas. I think that there is a real difference between
the research laboratory and the clinical laboratory. The
research laboratory that is trying to develop a vaccine or a
pharmaceutical is in true possession. They know what they have;
they know it is there; they know if they know if they anthrax
working with it. It is easy to register those facilities.
The clinical laboratories, though, do not know when a
patient comes in what they are going to isolate. They are not
necessarily preregistered to tell you we are going to be in
possession of anthrax. And in fact, under the national
laboratory network that we have established for laboratories,
the local clinical lab does not really accomplish the
identification; that goes on to a public health lab or to the
CDC to do. So the clinical lab may, in fact, be in possession
and never know they have the agent.
Now Senator Feinstein asked earlier about the CLIA
exemptions under the current select agent rule and in fact,
that is a necessary part because we do not want to delay the
shipment of the diagnostic specimen on up. If in the case of
Boca Raton, for example, we had to get rid of that sample and
not send it on because they had not preregistered for potential
possession of anthrax we would have had a serious problem in
knowing, in fact, that we were under a terrorist attack.
Now those clinical labs need to follow a different set of
rules. They need to destroy the agents once it has moved on and
that is, in fact, what the current select agent rule does. But
tens of thousands of CLIA-certified laboratories, probably
something like 150,000 diagnostic laboratories in the United
States. If we begin registering all of those who do not really
possess the agents then I think we have a mammoth bureaucratic
nightmare ahead of us that does not allow us to focus the
attention where it needs to be focussed.
Senator McConnell. Thank you, Dr. Atlas.
Thank you, Madam Chairman.
Chairperson Feinstein. Thanks very much, Senator.
Dr. Atlas and gentlemen, my staff has just handed me a copy
of a list of categories of equipment that would be covered by
the bill we are putting together involving this equipment. It
includes things like sophisticated fermentation equipment,
large temperature-controlled high-speed differential
centrifuges, cross-flow filtration equipment, freeze-drying
equipment, aerosol inhalation chambers, and certain
modifications with respect to airplanes, trucks, et cetera.
Would you take a look at this before you leave? Also there
is some bill language attached. Perhaps you would take a copy
with you and give us your input on that because I am sure there
are things that we have missed.
The Anti-Terrorism and Effective Death Penalty Act of 1996
set up a registration system for laboratories that transfer and
receive dangerous biological agents. The registration system
that the CDC has has a number of exemptions.
In light of this new threat, I would like to ask you about
the appropriateness of these exemptions. A, samples used for
diagnostic verification and reference purposes. What is the
American Society of Microbiology's view of exemptions for
diagnostic verification and reference purposes? Why shouldn't a
lab have to register if it keeps a reference sample of anthrax
or smallpox permanently at the lab?
Mr. Atlas. I think the answer is if they keep a specimen
beyond 48 hours they have to register and should have to
register. The only question on the exemption is the initial 48
hours during which a sample is being processed and sent on to
be identified, after which they have to destroy it. So it is
not that they should be able to maintain it. If they do, they
have to register like any other laboratory under the select
agent rule.
The question, as I indicated a few minutes ago, is in case
of Boca Raton don't we want that laboratory to be able to
possess it long enough to move it onward for the proper
diagnosis? But no--
Chairperson Feinstein. But it is also a loophole for
mischief.
Mr. Atlas. I do not know that there is any way of closing
that loophole when we are dealing with agents that occur
naturally. In the senator's home state of California where I
lived before coming to Kentucky, we see several cases of plague
occurring each year. The agent is present in various animal
populations in the state. We need to be able to allow both the
veterinary and the clinical diagnostic laboratories to make
appropriate diagnoses and then we must demand that they either
register, transfer them to registered laboratories and destroy
the agents within the set time limit, but again I would not
want to prevent someone from making the right diagnosis that is
going to save lives.
Chairperson Feinstein. Now let me ask all of you this
question. Why do you think the FBI and the Justice Department
is having such a difficult time determining the source of this?
I mean we know certain things about it that limits it to very
few sources of production so why is it so difficult?
Mr. Parachini. They are not here and I do not want to
comment but they have a culture that focusses on the crime and
works backwards. So you might ask, why haven't they worked
backwards this far? I think they follow the particular crime
and go back how that leads them, as opposed to sort of asking
the question, what is the full realm of possibility here and
let us identify all of the laboratories and all of the workers,
which would be one of the things one would want to do to have a
complete baseline of what is the potential out there.
I think it is their cultural approach about how they pursue
an investigation, which might be different or they might be
aided by more regulation in this area that started with a clear
baseline of what is out there and who has access to the
facilities.
Chairperson Feinstein. So you are saying go immediately to
these 500 sources?
Mr. Parachini. Or whatever the number might be. It could be
a good deal more than that. I am sure that Dr. Atlas's
laboratory is different but people work with things in their
laboratory and then they move on to other places and they
forget what the vials are in the place where they have worked
or people get sick and then die and their laboratories still
have the material in there. Mistakes happen. A clear accounting
of all of what is out there is probably a good place at some
point for us to get to.
Chairperson Feinstein. Dr. Atlas?
Mr. Atlas. Senator, there also is an inherent difference
between biological weapons and other sorts of weapons of mass
destruction. If I fill this glass with water--it's a chemical--
and someone takes half of it, you know it is gone but if it is
a biological agent and I fill it with water, I need to take
only a pinpoint out of there that you would never notice and
then I can grow tons of it elsewhere.
The other aspect that is different is with the exception of
smallpox, all of the other agents occur naturally.
One assumes right now that someone has gone into some
laboratory or culture collection and obtained the strain of
anthrax that is being spread maliciously through the mails.
Reality is that that same strain undoubtedly also exists in
nature and is killing animals and one could have found it out
there.
Unless we eradicate these infectious diseases, terrorists
will have sources of anthrax and plague and any number of other
agents in nature. So while we definitely should tighten the
regulations from a biosafety and a biosecurity standpoint on
our research and even our clinical labs, that does not
eliminate the threat of a bioterrorist acquiring agents that
can cause mass casualties.
Mr. Parachini. In fact, Senator, I might add that it is
worth remembering that Aum, the Japanese cult group, actually
did go to Zaire thinking that they could acquire some Ebola
virus. Now they went in a period where there were not actually
outbreaks but they thought about it so they did exactly that.
And it may be more difficult to actually monitor who is going
in and out of hot zones where there are emerging infectious
diseases, as opposed to laboratories where we know where they
are, for example, in the former Soviet Union and can focus our
attention on improving the security. We should do that but we
should also be aware of this more elusive source that pops up
around the world according to its own design and that it is
hard to anticipate where it is.
Chairperson Feinstein. But as everyone has said, this was
highly purified and there was a substantial amount of it, two
grams, in the envelope, and there was some kind of coating on
it, as yet undefined, as I understand it, which indicates to I
think everybody that has looked at it that a process took place
which was a sophisticated process.
So to me, that has to come from somewhere. It did not
likely come from someone in their bathroom cooking this stuff
up. It had to have come from somewhere. Then you get to the
point of well, if it is two grams, why was it only two grams?
Is there more? Is it three grams or four grams or five grams? I
guess if it takes certain equipment in certain labs to get
that, it seems to me that no-way, no-how in this country should
individuals be able to possess that outside of the lab setting,
which I gather right now our laws do not guarantee.
Mr. Atlas. If we could identify that equipment that went
from A to B, that is what took the agent and refined it and
treated it that way and there is specific equipment, then I
think I would agree with you that we should not possess that.
The other sort of equipment though, sort of going from just
a cell of bacillus anthraces to two grams of material--not
weaponized, not purified--that Iraq showed us could be done in
very small containers, in very nonsophisticated ways and that
we would not be able to capture or prevent individuals even
from having the sort of jars and jugs at home that one could do
that in.
Chairperson Feinstein. Well, now I am confused. You cannot
grow to the level of this anthrax at home, right?
Mr. Atlas. In my opinion you are correct but it is after
you have grown it. In other words, I think that the early part
of being able to culture the bacteria, to grow two grams of
bacteria, that is not a very sophisticated technology. Going
from there to reducing the charge or the engineering aspects,
once you go out of my area of expertise of microbiology to
someone else's area, in my view that becomes far more
sophisticated and it really is where the issue of equipment and
a different sort of expertise that tells you how to make a
biological weapon exists.
Chairperson Feinstein. Well, what do your microbiologists
say? Speculate just for a moment and this is pure speculation.
Where they do they think this kind of thing came from?
Mr. Atlas. I do not think we know. I think we really are
looking and waiting and we really do not know. I would say
every day I get a phone call telling me it came from somewhere
else, I know where it came from and that night it changes.
So I really wish I had a clue as to where it came from, who
is responsible. I do not know.
Chairperson Feinstein. One last question. In the CLIA labs,
the ones that are not required to register with CDC, I trust
you believe they should be?
Mr. Atlas. No. Again those are the laboratories that are
the diagnostic laboratories. They are required to destroy their
cultures. Those are the laboratories like the hospital in Boca
Raton that had the unfortunate experience of isolating bacteria
from a patient who was dying of anthrax and where they then
transferred that and destroyed the culture and did not actually
register as a laboratory that had been in possession
technically, I guess, of anthrax during the time of the 48
hours when they had isolated and until it was transferred and
destroyed.
Now had they maintained it, had they gone beyond that, then
they are required, they are not exempt and they are required to
register and that should, in fact, be done.
Chairperson Feinstein. You do not think it is worthwhile
having CDC know? Well, they do know.
Mr. Atlas. I think the CDC does know. I think that because
there is a requirement that it move from that laboratory to a
public health laboratory, that that is a requirement, that the
public health laboratory needs to notify the CDC, that there is
no question that there is a record of where it came from.
Chairperson Feinstein. Okay. And what is the verification
process when it is destroyed, that it has been destroyed?
Mr. Atlas. I do not know that there is a verification
process and that is something that could be looked at in my
view in terms of the regulatory oversight. As the secretary of
HHS presumably in the near future, depending on which
regulations we see come forward, will be charged with a new set
of regulations, I think that is a very appropriate question of
how that laboratory disposes of it and how we verify that it
has been appropriately disposed. There is a requirement that it
be either incinerated or autoclaved on site but that
verification, I think, is a good point, Senator.
Chairperson Feinstein. Right, thank you very much.
Does anybody have a last comment they would like to make?
Dr. Drake. I just have a comment. You mentioned
universities and the interest the reaction that people have
when they hear that new regulations are coming down and I just
would like to echo what Dr. Atlas was saying.
Participating in the process of defining what those rules
and regulations are going to be and having people who are
working in the field who can say gosh, this is something that
is likely to confer protection or this is something that is
likely to be an unusual burden are what people are concerned
about. So I just think that having an opportunity to
participate in the development of what the regulations are so
that they enhance our security but do not curtail the
legitimate and beneficial purposes that are going on in the
laboratory, I think that is one thing that is important.
Another comment I have on the concept of excluding
categories of individuals without exception, I would find that
to be limiting in many ways. I will use an example, not
necessarily a good example but let us say someone who might
have been dishonorably discharged from the military for sexual
preference decades ago or some other things like that. There
might be people who have had wonderful careers in research and
other things that are really contributing to the national good
and by exempting or excluding entire categories of individuals
without an opportunity for exception, I think we again could be
limiting our ability to do legitimate quality work.
Chairperson Feinstein. Well, as was pointed out, there
would be a waiver so that it could be waived, but at least the
case would have to be looked at.
Dr. Drake. Sure.
Chairperson Feinstein. One of the problems now is anybody
can possess it and I have a real problem with that.
Mr. Parachini. Senator, I would just add that it is
important that the Committee and you and your colleagues look
at not only the technology and baselining what we have at our
laboratories but it is not just a matter of the material and
the equipment but there is also the know-how an we have to be
creative about how we secure the know-how of doing this. As Dr.
Atlas mentioned, moving from developing a culture to actually
making the sophisticated material that showed up in the Senate
is an understanding about how you work with that material that
really weapon scientists have had, so there is the knowledge of
weapon scientists and then there is the skill of doing that.
So we need to be creative in thinking about how we control
that or how we know where that is; that is, the know-how and
the skill, which are different. I realize that goes into other
Committees' jurisdictions but I think this is a problem that
has many facets and to look at only one part of it in isolation
of the other, we may miss useful connections.
Chairperson Feinstein. Well, if you have some suggestions
we would be happy to hear them.
Let me say thank you very much. This has been a very
interesting hearing. I appreciate your expertise and the
information that you have added for our consideration.
So thank you and the hearing is adjourned.
[Whereupon, at 12:27 p.m., the Subcommittee was adjourned.]
[A submission for the record follows.]
SUBMISSION FOR THE RECORD
Statement of Claude Allen, Deputy Secretary, Department of Health and
Human Services
Good morning. I am Claude A. Allen, Deputy Secretary, Department of
Health and Human Services (HHS). I am pleased to be here to describe
HHS's role in regulating the possession, use, and transfer of select
agents that are capable of causing substantial harm to human health.
Overview of Existing Regulation
In recent years, the threat of illegitimate use of infectious
agents has attracted increasing interest from the perspective of public
health because certain select agents could seriously compromise human
health and safety. Recent use of anthrax as a bioterrorist agent has
heightened this concern. In general, the safety and security record in
the sale and transfer of these agents and substances for research has
been good. Moreover, continuing the shipment of infectious agents
between medical and research facilities is necessary to further medical
research and the diagnosis and treatment of infectious diseases. Each
year in the United States, thousands of samples of infectious agents
are shipped without incident.
Historically, HHS's Centers for Disease Control and Prevention
(CDC) has had the responsibility for providing guidance to the research
community for safely packaging and shipping biohazardous materials. The
Antiterrorism and Effective Death Penalty Act of 1996 required the
Secretary of Health and Human Services to promulgate new regulations
which resulted in a significantly expanded CDC role by placing
additional controls on the shipment of selected etiologic agents that
could be used for bioterrorist purposes. In response to the mandate, a
final regulation was published in October 1996 which became effective
on April 15, 1997. CDC has worked extensively with partners in the
scientific community to develop and implement the regulation on behalf
of HHS.
The regulation placed additional shipping and handling requirements
on facilities that transfer or receive select agents that are capable
of causing substantial harm t human health. For purposes of the
regulation, a select agent is defined as a microorganism (virus,
bacterium, fungus, rickettsia) or toxin, including genetically modified
or genetic material from those select agents, listed in the regulation.
The regulation was developed in consultation with an
interdepartmental workgroup, composed of representatives from within
the HHS and from other departments and agencies, including the
Departments of Justice (DOJ) and Defense (DOD). The goal in developing
the regulation was to balance the need to assure the availability of
materials to the scientific and medical community for legitimate
research purposes with the imperative of preventing access to these
agents for other uses. This regulation is designed to ensure that these
biological agents are shipped only to institutions or individuals
equipped to handle them appropriately and only to those who have
legitimate reasons to use them without posing undue burdens on the
legitimate user community. The regulation is based on key principles of
ensuring protection of public health without encumbering and
discouraging essential and legitimate scientific and medical research.
The regulation was designed to establish a system of safeguards to
be followed when specific agents are transported; collect and provide
information concerning the location where certain potentially hazardous
agents are transferred; track the acquisition and transfer of these
specific agents; and establish a process for alerting appropriate
authorities if an unauthorized attempt is made to acquire these agents.
The rule includes six fundamental components: (1) a comprehensive list
of select agents; (2) registration of facilities transferring these
agents; (3) transfer requirements; (4) verification procedures
including audit, quality control, and accountability mechanisms; (5)
agent disposal requirements; and (6) research and clinical exemptions.
(1) select agent list
The regulation includes a list of select agents subject to therule.
This list includes approximately 40 viruses, bacteria, rickettsiae,
fungi, and toxins with the potential to cause substantial harm to human
health. All materials that are known to contain or are reasonably
suspected of containing a select agent, unless exempted, are subject to
the regulation. The list is not meant to be static and agents can be
added or deleted as appropriate.
(2) registration of facilities handling select agents
Commercial suppliers of select agents, as well as government
agencies, universities, research institutes and private companies that
seek to transfer or receive these agents, are required to register with
CDC and obtain a unique site registration number. The registration
process requires that a responsible facility official certify that the
facility and its laboratories meet the Biosafety Level 2, 3, and/or 4
standards for working with dangerous pathogens as described in the 4th
edition of the CDC/NIH Biosafety in Microbiological and Biomedical
Laboratories (BMBL). Additional requirements for handling toxins are
found at 29 CFR 1910.1450 -``Occupational Exposure to Hazardous
Chemicals in Laboratories.'' The facility's unique registration number
indicates that the facility is registered to work with select agents at
a prescribed biosafety level. The number also is used to help validate
all requests for transfer of dangerous human pathogens.
(3) transfer requirements
Prior to transferring a select agent, both the shipping and
receiving parties must complete required sections of an official
transfer form. This form lists the agents and requires information
about the requestor as well as the transferor, including their
registration numbers, the type and amount of agent requested, and the
proposed use of the agent. This form must accompany the purchase order
and requests for obtaining these agents. Both the requesting and
transferring facilities must retain a copy of this form. In addition, a
copy is sent to CDC for documentation, and to be available to federl
and authorized state and local law enforcement authorities if needed.
The form also can be used for tracking purposes.
(4) verification procedures
To ensure management oversight of the transfer process, each
facility shipping or receiving a covered select agent must designate a
responsible facility official. The responsible facility official for
the requesting facility must sign each request. The responsible
facility official sending the agent must verify that the recipient
holds a currently valid registration number, indicating that the
recipient has the required biosafety level capability. If the
responsible facility official is unable to validate the necessary
information, the official contacts the CDC for assistance. If
appropriate, law enforcement authorities would be notified. Copies of
the completed form are required to be kept by both the requestor's and
transferor's facility. Receipt of an agent must be acknowledged by the
recipient within three working days.
CDC may inspect a registered facility, with or without cause, to
verify registration information and to ensure that the facility meets
the appropriate biosafety level requirements and complies with the
regulation. Routine inspections have been completed at approximately 60
registered facilities.
(5) agent disposal requirements
Select agents must be stored securely in accordance with prudent
laboratory practices, and facilities must have in place procedures for
the appropriate disposal of the agents. Disposal of select agents must
be at the facility, by known effective methods. CDC must be notified of
the disposal or complete consumption of a select agent.
(6) research and clinical exemptions
Licensed vaccines containing less pathogenic strains of some of the
select viral and bacterial agents are exempted from the list of agents.
Transport of clinical specimens for diagnostic and verification
purposes are also exempt, as are certain toxins used for legitimate
medical purposes or biomedical research. owever, isolates of agents
from clinical specimens must be destroyed or sent to an approved
repository after diagnostic procedures have been completed. Otherwise,
such isolates cannot be transferred to another site unless the
receiving site is registered.
Implementation Status
As of October 24, 250 facilities have completed the application
process and are now registered, including facilities at universities,
government agencies, private research institutions, and commercial
businesses. CDC has received transfer documents for more than 2500
shipments of select agents.
CDC has developed a computerized database to track applications,
registrations, and select agent transfers. A paper file is also kept on
each registered facility. All files are stored in accordance with HHS
data security policies. CDC has worked with FBI personnel and other
authorized law enforcement agencies to provide access to the
information when necessary.
Proposed Changes to Regulation
This month, Secretary Thompson developed a draft bill for the
consideration of Congress to improve the Department's ability to
prevent or respond to public health emergencies created by terrorist
attacks. The bill, the ``HHS Bioterrorism Prevention and Emergency
Response Act of 2001,'' makes amendments to the Federal Food, Drug, and
Cosmetic Act, the Public Health Service Act, and related statutes to
address several issues related to bioterrorism, including select
agents. Among other issues addressed, new authority would be provided
to regulate the possession, use, and transfer of those select agents
that the Secretary found to be a national security threat. The
Secretary would develop and implement an appropriate regulatory
framework to accomplish these safeguards.
Title II of the bill includes these provisions. Section 203(b)
would add to title III-F of the Public Health Service Act a new section
351B, directing the Secretary, by regulation, (1) to establish and
maintain a list of those biological agents and toxins lsted under
section 351A of that Act that the Secretary determines to be a national
security threat; and (2) to provide for the establishment and
enforcement of standards and procedures governing the possession, use,
and transfer of such agents and toxins designed to protect public
safety and national security, including safeguards to prevent access to
such agents and toxins for use in domestic or international terrorism
or for any other criminal purpose. Violations would be subject to civil
penalties of up to $250,000.
In determining whether to include an agent or toxin on the lists
for regulation of transfer or of possession or use, the Secretary will
consider the effect on human health of exposure to the agent or toxin,
the degree of contagiousness of the agent or toxin and the methods by
which the agent or toxin is transferred to humans, the availability and
effectiveness of pharmacotherapies and immunizations to treat and
prevent any illness resulting from infection by the agent or toxin, and
other appropriate criteria. In making these determinations, the
Secretary will consult with public health, scientific, intelligence,
and military partners.
Through the regulatory regime established, the Secretary will
provide for the establishment and enforcement of safety procedures for
the transfer of these biological agents and toxins. The regulations
will also provide safeguards to prevent access to such agents and
toxins for use in domestic or international terrorism or for any other
criminal purpose. Due to the extremely sensitive nature of the
information collected, the bill also provides an exemption from the
Freedom of Information Act for any information provided to the
Secretary under these regulations, or under CDC's current Select Agent
regulations.
Regulation within HHS Role for Public Health Response
The Secretary will develop and implement these expanded regulations
within its overall framework for public health preparedness for and
response to acts of bioterrorism. HHS is resonsible for the public
health response to any biological or chemical attack, as well as for
disease surveillance and medical preparedness. Our anti-bioterrorism
efforts are focused on improving the nation's public health
surveillance network to quickly detect and identify the biological
agent that has been released; strengthening the capacities for medical
response, especially at the local level; expanding the stockpile of
pharmaceuticals for use if needed; and expanding research on disease
agents that might be released, rapid methods for identifying biological
agents, and improved treatments and vaccines.
HHS appreciates the need to craft appropriate restrictions and
sanctions for improper possession and handling of these substances. We
believe it is critical for safeguards to be carefully balanced against
other important societal concerns, notably the need to support and
encourage legitimate and important research involving these substances.
Federal government agencies are actively collaborating with the private
sector on a wide range of research efforts addressing the bioterrorism
threat and these efforts need to be expanded. We must bring the best
and brightest minds to bear on the development of vaccines, antivirals,
antibiotics, and other therapies for exposure or illness due to
biologic agents; to develop and test protective equipment; and to
develop reliable, rapid assays capable of detecting minute
concentrations of biologic agents.
Conclusions
The Department of Health and Human Services is committed to working
with other federal agencies as well as state and local public health
partners to ensure the health and medical care of our citizens. We have
made substantial progress to date in enhancing the nation's capability
to respond to a bioterrorist event. But there is more we can do to
strengthen the response. Addressing the threat of bioterrorism requires
an unprecedented level of cooperation and partnership, bringing
together agencies with diverse missions. These include publi health and
law enforcement agencies, civilian and military agencies, and public
and private organizations. Finally, HHS fully supports criminal
sanctions designed to capture and punish those who possess these agents
for nefarious purposes. These sanctions need to be carefully developed
so that they do not unduly curb the research vitally needed to prepare
our nation to respond effectively to a bioterrorist attack in order to
minimize its consequences.
Mr. Chairman, that concludes my prepared remarks. I would be
pleased to answer any questions you or members of the Subcommittee may
have.
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