[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
                                 ------                                

   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

                              ----------                              

                    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

                              ----------                              


                       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
----------------------------------------------------------------------------------------------------------------
         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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