[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]



 
 THE THREAT OF BIOTERRORISM IN AMERICA: ASSESSING THE ADEQUACY OF THE 
          FEDERAL LAW RELATING TO DANGEROUS BIOLOGICAL AGENTS

=======================================================================

                                HEARING

                               before the

                            SUBCOMMITTEE ON
                      OVERSIGHT AND INVESTIGATIONS

                                 of the

                         COMMITTEE ON COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             FIRST SESSION

                               __________

                              MAY 20, 1999

                               __________

                           Serial No. 106-19

                               __________

            Printed for the use of the Committee on Commerce


                                


                      U.S. GOVERNMENT PRINTING OFFICE
 57-449 CC                   WASHINGTON : 1999
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                         COMMITTEE ON COMMERCE

                     TOM BLILEY, Virginia, Chairman

W.J. ``BILLY'' TAUZIN, Louisiana     JOHN D. DINGELL, Michigan
MICHAEL G. OXLEY, Ohio               HENRY A. WAXMAN, California
MICHAEL BILIRAKIS, Florida           EDWARD J. MARKEY, Massachusetts
JOE BARTON, Texas                    RALPH M. HALL, Texas
FRED UPTON, Michigan                 RICK BOUCHER, Virginia
CLIFF STEARNS, Florida               EDOLPHUS TOWNS, New York
PAUL E. GILLMOR, Ohio                FRANK PALLONE, Jr., New Jersey
  Vice Chairman                      SHERROD BROWN, Ohio
JAMES C. GREENWOOD, Pennsylvania     BART GORDON, Tennessee
CHRISTOPHER COX, California          PETER DEUTSCH, Florida
NATHAN DEAL, Georgia                 BOBBY L. RUSH, Illinois
STEVE LARGENT, Oklahoma              ANNA G. ESHOO, California
RICHARD BURR, North Carolina         RON KLINK, Pennsylvania
BRIAN P. BILBRAY, California         BART STUPAK, Michigan
ED WHITFIELD, Kentucky               ELIOT L. ENGEL, New York
GREG GANSKE, Iowa                    THOMAS C. SAWYER, Ohio
CHARLIE NORWOOD, Georgia             ALBERT R. WYNN, Maryland
TOM A. COBURN, Oklahoma              GENE GREEN, Texas
RICK LAZIO, New York                 KAREN McCARTHY, Missouri
BARBARA CUBIN, Wyoming               TED STRICKLAND, Ohio
JAMES E. ROGAN, California           DIANA DeGETTE, Colorado
JOHN SHIMKUS, Illinois               THOMAS M. BARRETT, Wisconsin
HEATHER WILSON, New Mexico           BILL LUTHER, Minnesota
JOHN B. SHADEGG, Arizona             LOIS CAPPS, California
CHARLES W. ``CHIP'' PICKERING, 
Mississippi
VITO FOSSELLA, New York
ROY BLUNT, Missouri
ED BRYANT, Tennessee
ROBERT L. EHRLICH, Jr., Maryland

                   James E. Derderian, Chief of Staff
                   James D. Barnette, General Counsel
      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                 ______

              Subcommittee on Oversight and Investigations

                     FRED UPTON, Michigan, Chairman

JOE BARTON, Texas                    RON KLINK, Pennsylvania
CHRISTOPHER COX, California          HENRY A. WAXMAN, California
RICHARD BURR, North Carolina         BART STUPAK, Michigan
  Vice Chairman                      GENE GREEN, Texas
BRIAN P. BILBRAY, California         KAREN McCARTHY, Missouri
ED WHITFIELD, Kentucky               TED STRICKLAND, Ohio
GREG GANSKE, Iowa                    DIANA DeGETTE, Colorado
ROY BLUNT, Missouri                  JOHN D. DINGELL, Michigan,
ED BRYANT, Tennessee                   (Ex Officio)
TOM BLILEY, Virginia,
  (Ex Officio)

                                  (ii)



                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
    Atlas, Ronald M., Co-Chair, Task Force on Biological Weapons 
      Control, American Society for Microbiology.................    47
    Burnham, Robert M., Chief, Domestic Terrorism Section, 
      National Security Division, Federal Bureau of Investigation    16
    Connell, Nancy D., Associate Professor of Microbiology and 
      Molecular Genetics, Department of Microbiology, University 
      of Medicine and Dentistry of New Jersey....................    55
    Ostroff, Stephen M., Associate Director for Epidemiologic 
      Sciences, National Center for Infectious Diseases, Centers 
      for Disease Control and Prevention accompanied by Jonathan 
      Richmond, Director, Office of Health and Safety, Centers 
      for Disease Control and Prevention.........................    22
    Preslar, Dorothy B., Washington Project Officer, Biological 
      Weapons Verification Project, Federation of American 
      Scientists.................................................    53
    Raub, William F., Deputy Assistant Secretary for Science 
      Policy, Department of Health and Human Services............    21
    Reynolds, James S., Chief, Terrorism and Violent Crime 
      Section, Criminal Division, Department of Justice..........    12
Material submitted for the record by:
    Holmer, Alan F., President, Pharmaceutical Research and 
      Manufacturers of America, prepared statement of............    69
    Ostroff, Stephen M., Associate Director for Epidemiologic 
      Sciences, National Center for Infectious Diseases, Centers 
      for Disease Control and Prevention, responses for the 
      record.....................................................    68

                                 (iii)



 THE THREAT OF BIOTERRORISM IN AMERICA: ASSESSING THE ADEQUACY OF THE 
          FEDERAL LAW RELATING TO DANGEROUS BIOLOGICAL AGENTS

                              ----------                              


                         THURSDAY, MAY 20, 1999

                  House of Representatives,
                             Committee on Commerce,
              Subcommittee on Oversight and Investigations,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 9:30 a.m., in 
room 2322, Rayburn House Office Building, Hon. Fred Upton, 
(chairman), presiding.
    Members present: Upton, Burr, Bilbray, Ganske, Blunt, 
Bryant, Bliley (ex officio), Stupak, Green, McCarthy, and 
DeGette.
    Also present: Representative Markey.
    Staff present: Tom DiLenge, majority counsel; Kevin Cook, 
professional staff member; Anthony Habib, legislative clerk, 
and Edith Holeman, minority counsel.
    Mr. Upton. The subcommittee will be in order.
    We are here today to hold an oversight hearing on the 
adequacy of the current Federal laws and regulations relating 
to dangerous biological agents. The concern here is not just 
the potential for these agents to be used for terrorism, or 
other criminal purposes; but also the clear threat to public 
health and safety posed by inadequate controls on who can 
possess these deadly agents, for what purposes, and under what 
conditions.
    In response to similar concerns, Congress passed the Anti-
Terrorism Act in 1996, part of which was designed to begin 
imposing some controls on the transfer of certain biological 
agents that pose an extreme risk to human health such as 
anthrax, the plague, smallpox, and the ebola virus. That task 
fell to the Centers for Disease Control and Prevention, 
``CDC.'' These rules require that those who send or receive 
specified agents must first register with the CDC. CDC is 
supposed to take steps to assure itself that the recipients are 
legitimate and competent users of these deadly agents, which do 
have useful scientific and medical purposes beyond their 
potential for weaponization.
    What the rules don't require, however, is equally important 
to understand. The rules only cover those who acquire these 
agents through some self-disclosed transaction with another 
legitimate supplier. They do not cover those who 
surreptitiously acquire these agents through less formal 
transfers, or who culture these organisms on their own from 
naturally occurring sources. The rules also do not cover those 
who receive these agents prior to their effective date of April 
15, 1997, which has provided quite a large loophole in the 
coverage of these controls.
    So far, the number of registering entities has been limited 
to a small universe of well-known academic, Government, and 
commercial labs. This small number, about 120 facilities out of 
a pre-rule estimate of 200-300 registrants, suggests that there 
may be substantial non-compliance with the CDC rules. The 
current rule's focus on transfers, rather than possession, 
probably encourages such non-compliance; since it would be 
difficult for an enforcement agency to demonstrate that a 
possessor violated any transfer rules, unless the possessor is 
actually caught in the specific act of transferring or 
receiving.
    I also have concerns about whether CDC has the necessary 
resources to fully ensure that even those facilities that do 
self-register are capable and equipped to handle these highly 
dangerous agents in accordance with CDC's biosafety guidelines. 
CDC has not conducted any preapproval inspections of 
registering facilities; although recently CDC has begun to 
conduct inspections of already-registered facilities, 
completing roughly a dozen such inspections, to date. In one of 
these cases, CDC had to order a suspension of all work on a 
dangerous agent, because of the facility's significant non-
compliance with the prudent safety procedures.
    Biosafety, while certainly important, often does not 
address the related issue of biosecurity, that is: are these 
facilities making sure that these deadly agents are secure from 
theft, or removal by internal and external sources? I 
understand that CDC is in the process of revising its biosafety 
guidelines to include recommended assessments of physical 
security, which is certainly a good start. But as our CDC 
witnesses today previously testified, it seems clear that many 
of our excellent research facilities have not given the same 
level of concern to security as they have to safety. While 
there are only a few cases they know about in which deadly 
agents have been taken from lab for criminal purposes, we 
should not take too much comfort in that fact.
    As we will hear today, there are questions as to whether 
these labs, and other possessing entities such as hospitals, 
maintain sufficiently strict inventory and tracking controls 
over these agents. Thus, they may not even know if anything is 
missing. Also, there is no current requirements that facilities 
report the theft or loss of such agents to authorities. So, 
again, we don't always know what we don't know.
    All of this suggests that we need to consider reasonable 
safety measures to further enhance our competence in the safety 
and security of dangerous biological agents. While we should 
not act in a manner that discourages legitimate and necessary 
scientific research into these same organisms, the public 
policy history in this area has been one of reaction to bad 
events, rather than pro-active thinking. I think that waiting 
for some deadly terrorist attack with these agents to occur 
before taking further action is not only short-sighted, but 
would also poorly serve the American people.
    As FBI Director Freeh has stated, we are dealing with a 
low-probability event, but with certain extreme, catastrophic 
consequences. We need to be prepared for those consequences, 
but we also need to do what we can and what is reasonable to 
prevent such a catastrophe from occurring in the first place.
    As an editorial in the Washington Post stated last year, 
our current laws on who can gain access to anthrax, or other 
deadly, disease-causing microbes have, ``A real gap, one that 
may offer unstable characters too wide a defense when caught 
red-handed with materials that could cause widespread damage.'' 
The Post went to say that while the legitimate uses of these 
materials should be respected, it is worth considering whether 
those who keep biological agents should be obliged to notify 
Federal authorities. It is also worth considering whether law 
enforcement should really carry the burden of proving that 
someone in authorized possession of biological warfare agents 
actually means to use them.
    I hope that today we can begin such a bipartisan 
discussion. I welcome all of our witnessers to the hearing. I 
recognize, now, Mr. Stupak, from Michigan.
    Mr. Stupak. Thank you, Mr. Chairman. When the majority 
staff started looking into the issue of the control of special 
biological agents, it was billed as a review of whether the 
regulations controlling the transfer and shipment of these 
agents, and numerous other dangerous biological materials, are 
working. These regulations resulted from an incident in which 
an individual misrepresented himself and obtained botulism from 
a commercial laboratory. Now shippers and receivers have to 
register with the Centers for Disease Control and follow other 
procedures.
    These regulations seem to be working well for the narrow 
purposes for which they were intended. Whether they work for 
the broader purpose of preventing future bioterrorism is 
questionable. If you believe that there are bioterrorists 
lurking around every corner--as many seem to--the threshold 
question for this committee is whether putting special 
biological agents in the unregistered, unarmed, untrained, 
unknowing, anonymous hands of the Federal Express, or UPS, or 
the U.S. Postal workers for shipment is adequate protection. 
First, do these people know what they are handling? Are they 
trained to handle it? Can they be trusted? These are the first 
questions I would ask before I talked about weaponizing private 
laboratories doing non-military research.
    But as the testimony today will make evident, events have 
overtaken such illogical review. Last week, the administration 
issued a statement indicating that it was proposing to 
criminalize the unauthorized possession of these biological 
agents, require some background or security checks for all 
persons working in laboratories with these agents, and hold 
accountable people who knowingly disregard public health and 
safety when handling these agents.
    The statement is vague in the extreme. But it appears to 
require a massive new regulatory scheme that is so 
controversial inside the administration that it forced major 
revisions in CDC's testimonies yesterday, and delayed receipt 
of the Justice Department, FBI, and HHS testimony until close 
to midnight, last night. We now seem to be discussing to what 
extent should we weaponize the control of these agents from the 
cradle to the grave, similar to our controls of nuclear 
materials. Who should do it? Who should pay for it? The 
shipping remains in the hands of commercial couriers.
    The entertainment and news media have spun out numerous 
scenarios of terrorists who attack entire cities with 
biological weapons. However, it is extremely difficult to 
weaponize these agents effectively, even with a national 
effort. The real reasons that scientists work with these agents 
and other dangerous, infectious viruses and toxins, and send 
them from one lab to another, is for public health purposes: to 
identify and protect us from epidemics of infectious diseases 
that have, and still do, sweep through parts of the world.
    This is a greater--and a more certain--threat than 
bioterrorism has ever been. Over 100,000 Americans die every 
year from infectious diseases, and $30 billion is spent in 
direct-treatment expenses. Most of the people who have died 
from laboratory handling of these agents and other infectious 
materials in the United States have been the dedicated workers 
in universities and private laboratories who are accidently 
infected while doing this vital research. On the other hand, 
the crimes involving these agents have not been by terrorists, 
but by laboratory personnel attempting to infect their personal 
enemies.
    How real is the threat? Many experts believe that no 
terrorist today has the expertise to develop and effectively 
disseminate bioweapons. We know it is difficult enough to 
require concerted national efforts by trained scientists to 
develop the agents used, and more importantly, design effective 
delivery systems. As staff was told by FBI this week, Russia 
employed 600,000 people in its biological weapons program.
    The question, then, is whether we want to treat all of the 
laboratories doing non-military disease research with these 
biological agents as weapon laboratories, with the security and 
control that we provide our nuclear weapons laboratories. This 
committee is very familiar with the security at weapons 
laboratories. They are federally controlled. They were 
constructed to be physically isolated and tightly guarded. 
There are many layers of physical security barriers to protect 
nuclear materials. Materials are heavily guarded and escorted 
when they leave the facilities. It can take months to arrange a 
shipment. Persons working with special nuclear materials and 
classified information have security clearances. No foreign 
nationals, even those with permanent residency, are allowed to 
work in these areas. The cumulative cost is billions of 
dollars.
    Is this what we want for every laboratory that works with 
special biological agents, usually for vaccine purposes? They 
were not built with that tent. It would be extremely difficult 
to retrofit them to achieve that security level. Who will pay 
for it? What will the regulatory and inspection scheme be? Will 
the laboratories just drop the work because it has become too 
burdensome to do?
    Some have suggested a regulatory and inspection scheme 
similar to that of the Nuclear Regulatory Commission for 
civilian nuclear power plants. Who will do it? The Centers for 
Disease Control, which has responsibility for implementing the 
shipping regulations, clearly does not want to do it.
    CDC is a premiere, public-health research agency with no 
expertise in regulatory or law enforcement. The shipping 
regulations were the first this agency ever issued. It also has 
a strong desire to keep paramount its collaborative scientific 
relationship with the laboratories, as it told us in no 
uncertain terms, in the testimony it submitted yesterday. 
Yesterday, someone removed the objections out of the CDC's 
testimony, which we will, hopefully, get to talk about later.
    Should a new agency be set up specifically for this 
purpose? What role will the inspection agency play in 
biological weapons convention? My sense, Mr. Chairman, is that 
there is a rush for action many have claimed credit for. But no 
one has really thought through these issues. I hope we don't 
suddenly start down the road where we put more burdens on the 
CDC where they are not trained, or their mission statement is 
for that, and we hamper our research in biological and disease 
control.
    With that, I yield back, Mr. Chairman.
    Mr. Upton. Thank you, Mr. Stupak. I recognize the chairman 
of the full committee, Mr. Bliley.
    Chairman Bliley. Thank you, Mr. Chairman. The threat of 
bioterrorism can be overstated, but the importance of today's 
hearing cannot be. This committee's oversight has revealed, as 
we will hear today, that improving controls on dangerous 
biological agents is something that this country has only just 
begun to take seriously.
    There are a few documented instances of terrorists using 
biological agents. But a greater number of cases show that 
terrorists and other criminal elements have either acquired or 
tried to use these agents, or actively considered such use, as 
in the case of the World Trade Center bombing. Indeed, the cult 
that carried out the Sarin gas attack in Tokyo's subway 
attempted to use anthrax and other biological agents against 
innocent populations on nine prior occasions.
    Fortunately, terrorists employing such agents have had 
relatively little success so far. But we should not allow that 
fact to lull us into a false sense of security. Both the FBI 
and the CIA have expressed publicly their concerns that 
terrorist interest in biological agents is growing in breadth 
and sophistication and that disturbing trend represents one of 
the gravest threats to our national security. In fact, the 
President and other senior administration officials have 
indicated their belief that such a terrorist attack is ``highly 
likely'' to occur in this country in the foreseeable future, 
and have sought more than a billion dollars to enhance our 
Nation's capabilities to respond to a biological or chemical 
attack.
    We also have every reason to believe that the level of 
technological capability among terrorists will continue to 
grow, making it more likely that they will be able to 
effectively employ these deadly agents. Experts tell us that 
some terrorists have been perfecting aerosol dissemination of 
these agents--the most dangerous kinds--and others have been 
developing ever-more lethal forms of these agents to increase 
their deadly impact.
    Thus, while our limited experiences with past acts of bio-
terrorism should inform our policy judgments, they must not 
dictate our conclusions about what the future holds in this 
area. And what we don't know is often times worse than what we 
do know. What we do know is that the consideration of further 
reasonable precautions certainly is warranted.
    I think it is fair to say that the minimal Federal controls 
in this area would come as quite a surprise to the average 
American citizen. As we will hear today, we permit anyone in 
this country--including felons, foreign nationals from 
sensitive countries, and members of extremists groups--to 
lawfully possess even the most deadly biological agents, 
including anthrax, the plague, and the ebola virus. They don't 
even have to notify or register with any Federal agency or gain 
government approval to possess them. It doesn't matter if they 
have a legitimate scientific purpose, or even if they are 
credentialed scientists. It also doesn't matter if they possess 
these public health hazards in their garages or in their 
basements--they do not have to be in the confines of a 
legitimate or secure research laboratory. Simply put, if the 
FBI can't prove their intent to the agents as a weapon, current 
law can't touch these people, despite the real threat that 
their possession may pose to public health and safety.
    I am pleased that this committee is following-up on the 
good start made by our Senate colleagues last spring, when a 
bipartisan chorus of Senators raised similar questions to a 
similar panel of witnesses. At that time, the administration 
pledged to move quickly to assess whether new laws were needed. 
Yet when this committee began our oversight in January, the 
administration was still missing in action--despite the efforts 
of some individuals to press the issue forward. And when the 
President announced his anti-terrorism initiatives earlier this 
year without any mention of our lax Federal laws on biological 
agents, I urged him to consider ways to keep these deadly 
organisms out of the wrong hands in the first place.
    I wrote the Attorney General several months ago to express 
my concern that the administration's review of current 
bioterrorism laws was not receiving the priority it deserved. 
While I have yet to receive a response, I am pleased that 
today's hearing seems to have prompted the administration 
toward action. I understand that we will hear today some 
general ideas from the administration on how Congress could 
begin to fix this problem, and I look forward to receiving and 
reviewing more concrete proposals as we move beyond oversight 
and into the legislative arena. Thank you, Mr. Chairman.
    Mr. Upton. Thank you. I recognize Ms. McCarthy, for an 
opening statement.
    Ms. McCarthy. Thank you, Mr. Chairman, for conducting this 
hearing and for the panelists you have brought together. I 
would like submit my remarks for the record and move on to the 
testimony.
    [The prepared statement of Hon. Karen McCarthy follows:]
Prepared Statement of Hon. Karen McCarthy, a Representative in Congress 
                       from the State of Missouri
    Mr. Chairman, I would like to thank you for holding this hearing 
and to thank our witnesses for joining us today. We will be asking some 
difficult questions today. The end of this century is an exciting time, 
with many innovative technological advances to improve the public 
health and quality of life. At the same time, these same technological 
advances bring new threats to our safety and well being.
    Many scientists and laboratories across this country are working 
diligently to find cures and vaccines for the diseases which threaten 
our health. These same labs are responsible for dealing with 
emergencies when a virus or other biological agent gains exposure in a 
community. In order to accomplish this work, biological agents must be 
transported quickly from lab to lab so that experts can work together 
to identify a sample and develop an intervention plan.
    The scientific community has a history of dealing effectively and 
safely with these biological agents. We must therefore be careful to 
preserve the integrity of the scientific community. Scientists need to 
work with their peers and to have access to the materials and other 
resources to protect us from these biological agents.
    In the past several years, however, new threats have emerged. In 
the wrong hands, biological agents can be used to infect individuals 
with dread diseases. As such, we must examine this issue closely now.
    This balancing act will be the key to finding a sound solution to a 
pressing problem. I applaud the Administration's initial efforts to 
solve this pressing problem, and I urge the Administration to continue 
to pursue this issue until it is resolved. I look forward to our 
discussion today and to reviewing the President's plan to address this 
issue, and I hope that we will all work towards a consensus that allows 
us both to protect against terrorists and to foster scientific 
advancement. Thank you, Mr. Chairman.

    Mr. Upton. I appreciate that. All members of the 
subcommittee will have a chance, by unanimous consent, to enter 
their remarks into the record as part of their opening 
statement. Mr. Blunt.
    Mr. Blunt. Thank you, Mr. Chairman. Thank you for 
conducting this hearing.
    I think it is clear to all of us that there has been a 
change in the world in the last decade. The world is, in a 
macrosense, a much safer place; but in a micro-sense, it is a 
much more dangerous place. This may be the single biggest 
concern in that area, that microarea, of things that can 
happen, as the Chairman has mentioned, and the administration 
says is highly to happen. I think our experience in Iraq has 
given us plenty of evidence of the difficulty of monitoring the 
potential production, outside this country, of these kinds of 
agents. I believe we have to be working hard now to avoid 
reacting at some future time with that 72-hour solution. It 
will be tempting for people to rush to the podium and say, 
``Here is what we should do to prevent these kinds of things 
from every happening again.''
    I think your hearing, and the leadership of you and the 
chairman of the full committee on this issue, gives us a chance 
to think in advance of that action occurring of what we could 
do to prevent it from ever happening the first time; and what 
we could do to react, and the best possible way, if it does 
happen. I think it is an area of substantial concern and very 
appropriate for you to have this hearing on. I am pleased that 
you are having it and am glad to be part of it.
    Mr. Upton. Thank you. Mr. Green.
    Mr. Green. Thank you, Mr. Chairman. I will submit my full 
remarks. I have some concerns and look forward to the panel 
today. Coming from Houston, where we have a strong 
petrochemical industry, the right-to-know issues are very 
important. I know in the last year or so, the CDC has taken 
position, often times, that communities don't have that right 
to know what laboratories or companies are shipping. Also, even 
the shippers, maybe, don't have the proper labeling, or the 
proper knowledge by the UPS, FedEx, or our own Postal Service 
going from lab to lab. I would hope we could also explore those 
avenues. I look forward to the hearing.
    [The prepared statement of Hon. Gene Green follows:]
  Prepared Statement of Hon. Gene Green, a Representative in Congress 
                        from the State of Texas
    Mr. Chairman, I would like to start by thanking you for holding 
this important hearing on a subject that has been the topic of much 
speculation and fear. I would hope that one of the results of this 
hearing is a better understanding of the threats to the American people 
from bioterrorism, and that we can begin to separate what is truly 
dangerous and what is nothing more than hype.
    We come together today to examine a threat, a by-product of the 
modern world in which we live--the threat of bioterrorism.
    Since the tragedies of such attacks as the World Trade Center and 
the Oklahoma City bombing, the federal government and Congress have 
taken a much more active role in attempting to manage this threat, 
balancing the needs of different sides, but seeking above everything 
else to protect the safety of the American people.
    The stated purpose of this hearing is explore whether or not 
existing federal law is adequately protecting our homes and families, 
and whether or not it should be strengthened. There also appears to be 
some debate over which agencies should take the lead, not only in 
enforcing current law, but also administering any new guidelines that 
might come from this Congress.
    I would like to raise additional concerns. Being from Houston, with 
its strong petrochemical industry, the right-to-know issues has long 
been important to the communities that I represent.
    From what I understand, the CDC has taken the position that 
communities do not have the right-to-know what laboratories or 
companies are shipping, receiving or experimenting with these 
potentially deadly biological agents.
    That is a position I would strongly disagree with. People should be 
able to know if dangerous hazards are being stored near their homes and 
businesses.
    Also, the lack of access to this information impedes the ability of 
state and local officials to prepare evacuation plans and to ensure the 
safety of citizens should a disaster strike.
    Another issue of concern to me is the shipment of these biological 
agents. As I understand it, many of these materials are shipped from 
lab to lab via overnight delivery services, such as UPS or FedEx.
    I am concerned about the level of notification that these shippers 
receive. Are they being properly notified of the contents of these 
packages so that they can treat them with the extreme care that such 
dangerous materials require?
    While an accident has never happened, one can only imagine the 
tragedy that could result from a simple auto accident involving a 
delivery service van. If the agents contained in a package on that van 
were somehow released, hundreds of people could be exposed before 
anyone knew of the danger.
    Finally, another issue of concern to me deals with the personnel 
who handle these agents in the labs. While I think we all agree that 
keeping people with criminal pasts away from these materials is 
desirable, who will be responsible for conducting these background 
checks?
    Also, many of the people involved with these agents do not have 
criminal records, at least not until they misuse them. Background 
checks will not halt their access to dangerous agents.
    Furthermore, with the many university labs that are involved in 
legitimate research, undergraduate and graduate students from abroad 
handle these materials every day. Would background checks unreasonably 
delay their ability to work with these materials, thus crippling vital 
research?
    Mr. Chairman, I hope that we can get answers to some of these 
questions and I look forward to the testimony of the various 
representatives gathered before us today.

    Mr. Upton. Thank you. Mr. Bilbray.
    Mr. Bilbray. Yes, Mr. Chairman. I would like to echo the 
comments of my colleagues on, especially, the issue that we are 
addressing this item with a cool, calm approach; without 
feeling that we have to do anything, or everything even, if it 
may not work out. I think too, sadly, in the past Congress 
waited for a crisis to occur, and then, basically, approached 
the old argument of, ``Just do something''--not really 
considering if it will actually address the problem and 
comprehensively solve the issue.
    I appreciate the chance that we are able to discuss this in 
the realm of practical application, of real threat, and real 
answers. I have to really commend my colleagues on both sides 
of aisle of saying that we need to talk about what is the 
reality out there; and what are approaches that can actually 
address the issues, rather than just give a cosmetic veneer to 
the fact that we, somehow, solved it for now. Then, when the 
problem arises, we will say, ``We have to do more,'' even 
though it is not substantive.
    Thank you, Mr. Chairman. I yield back my time.
    Mr. Upton. Thank you. Mr. Bryant.
    Mr. Bryant. Thank you, Mr. Chairman. I, too, would add my 
appreciation for this hearing. As my colleagues from Missouri 
and California have alluded to in their statements, it is good 
that we have these hearings now, and begin to discuss this most 
serious issue in a calm and cool atmosphere, rather than as a 
reaction to a tragic situation that could occur in the future.
    As we are seeing more and more today with our society, it 
is certainly not beyond the realm of probability that we could 
have an incident involving this type of terrorism. I am not 
talking simply about foreign terrorists, but about our own 
people in this country performing such an act. I think that not 
only do we need to begin to look forward to that situation and 
be prepared, but maybe even taking steps today can actually 
prevent such situations from occurring.
    As a former United States Attorney, I am concerned with 
enabling our law enforcement personnel to effectively fight 
crime, and, in this case, terrorism. I know this committee and 
its staff has worked very diligently with interviewing 
interested people from the law enforcement community, as well 
as the scientific and pharmaceutical communities.
    As happens with all issues up here, it seems, you have 
different opinions. We all recognize that there is a problem 
here, and that there is a potentially larger problem. How do we 
deal with that? How do we reach that solution when different 
groups from different perspectives have different solutions?
    I am confident, that as we work through this process in 
this subcommittee and the full committee, and perhaps even at 
the congressional level and in legislation, a fair balance can 
be achieved to protect. It is almost like you are making the 
Second Amendment argument on guns. It is somewhat analogous to 
that: differentiating the people who want to lawfully use these 
chemicals and who have a need to do that, from those people who 
would misuse those chemicals to commit crimes. That is where 
you draw the line. This is the important issue that we, as the 
Congress, must decide.
    I look forward to hearing the distinguished panelists 
today, and the testimony that will come forward in helping to 
assist us to do this. There are very important matters that we 
have to deal with here. I thank, again, the Chair for convening 
this hearing.
    Mr. Upton. Thank you, Mr. Bryant.
    Again, I wanted to make the announcement that all members 
of the subcommittee will have a chance, by unanimous consent, 
to put their opening statement into the record.
    [Additional statements submitted for the record follow:]
 Prepared Statement of Hon. Richard Burr, a Representative in Congress 
                    from the State of North Carolina
    Thank you, Mr. Chairman, and I will keep my statement brief. It is 
said that the use of a biological weapon on a civilian population by 
terrorists is a low probability event, but one that would have very 
high consequences. As such, we cannot ignore any aspect of our 
country's policy on combating terrorism--especially bioterrorism. If we 
don't get it right the first time, thousands of lives could be in 
jeopardy.
    Preparing for a biological weapons attack is unlike preparing for 
any other mass-casualty event. There is the distinct possibility we 
would never know who carried out an attack. We would not likely see 
fire engines and police cars rushing to the scene, as we might in a 
chemical weapons attack. We would not likely see ambulances rushing to 
the scene to carry away the wounded. More than likely, we would witness 
only crowded doctors' offices and emergency rooms. Those affected by 
the attack might only exhibit cold- and flu-like symptoms, days after 
initial exposure, and get sent home for bed rest. Only on a second 
visit to the hospital would we begin to realize the magnitude of what 
had happened.
    It is crucial that this Congress take steps to plug the gaps that 
exist in current law regarding possession and transfer of dangerous 
biological agents, and I look forward to hearing the testimony today. I 
was pleased to hear the President address this issue in announcing his 
omnibus crime bill, and I look forward to seeing the legislative 
proposals.
    Having said that, Mr. Chairman, I am also hopeful this 
subcommittee, as well as the full committee, will continue to examine 
our nation's bioterrorism policies and programs. This year's budget saw 
a massive increase in the amount of funding requested to support those 
policies and programs, and we have a responsibility to examine the 
effectiveness of them. Thank you, Mr. Chairman.
                                 ______
                                 
    Prepared Statement of Hon. Henry A. Waxman, a Representative in 
                 Congress from the State of California
    Mr. Chairman, I am pleased you have called this hearing. In the 
past few years, Congress and the Administration have worked closely 
together to develop a comprehensive national strategy to address the 
potential threat of bioterrorism. Federal agencies have also 
effectively coordinated their work with medical and scientific experts, 
as well as State and local law enforcement and public health 
authorities.
    Today, however, we will focus on important but unresolved questions 
about how we should allocate responsibilities and which policies are 
most appropriate to pursue. For three years, the Centers for Disease 
Control and Prevention (CDC) have had the job of registering facilities 
transferring select biological agents, such as Ebola virus and the 
botulism bacterium, which potentially pose a severe public health 
threat.
    The Administration's forthcoming proposal to expand the law to 
newly monitor those who possess such biological agents raises a 
question which I am very concerned about--who will inspect facilities 
or scrutinize researchers for compliance? Who will act as the enforcer?
    CDC is internationally respected for its scientific and public 
health expertise. It is not primarily a regulatory agency. It relies 
upon the cooperation of our country's research community. CDC personnel 
do not, by and large, carry a badge to work.
    I want to emphasize from the onset that--regardless of the merits 
of new controls on the possession of select biological agents--
burdening CDC with new regulatory duties of inspection and verification 
seems to me to be inconsistent with CDC's mission of public health 
surveillance and disease prevention. I fear it would be inimical to 
their collaborative work with the research community here and abroad. 
And perhaps most importantly, it would be an ill-considered revision of 
CDC's existing priorities for responding to bioterrorism, which were 
clearly and intelligibly articulated by the CDC to Congress as recently 
as a month ago.
    Again, I thank the Chair for calling this hearing. This 
Subcommittee has an important role to play in assuring that our 
national preparedness against the threat of bioterrorism is founded on 
well-reasoned policy.
                                 ______
                                 
 Prepared Statement of Hon. Bart Stupak, a Representative in Congress 
                       from the State of Michigan
    Thank you, Mr. Chairman. When the majority staff started looking 
into the issue of the control of special biological agents, it was 
billed as a review of whether the regulations controlling the transfer 
and shipment of these agents and numerous other dangerous biological 
materials were working. These regulations resulted from an incident in 
which an individual misrepresented himself and obtained botulism from a 
commercial laboratory. Now shippers and receivers have to register with 
the Centers for Disease Control and follow other procedures.
    These regulations seem be working well for the narrow purpose for 
which they were intended. Whether they work for the broader purposes of 
preventing future bioterrorism is questionable. If you believe that 
there are bioterrorists lurking around every corner--as many seem to--
the threshold question for this Committee is whether putting special 
biological agents in the unregistered, unarmed, untrained, unknowing, 
anonymous hands of Federal Express or UPS or the U.S. Post Office 
workers for shipment is adequate protection. First, do these people 
know what they are handling? Are they trained to handle it? Can they be 
trusted? These are the first questions I would ask before I talked 
about weaponizing private laboratories doing nonmilitary research.
    But as the testimony today will make evident, events have overtaken 
such a logical review. Last week, the administration issued a statement 
indicating that it was proposing to criminalize the unauthorized 
possession of these biological agents, require some background or 
security check for all persons working in laboratories with these 
agents, and ``hold accountable'' persons who ``knowingly disregard 
public health and safety'' when handling these agents. The statement is 
vague in the extreme, but it appears to require a massive new 
regulatory scheme that is so controversial inside the administration 
that it forced major revisions in CDC's testimony yesterday and delayed 
receipt of the Justice, FBI and HHS testimony until after 7 p.m. last 
night. We now seem to be discussing to what extent we should 
``weaponize'' the control of these agents from the cradle to the 
grave--similar to our controls of nuclear materials--who should do it 
and who should pay for it. But the shipping remains in the hands of 
commercial couriers.
    The entertainment and news media has spun out numerous scenarios of 
terrorists who attack entire cities with biological weapons. However, 
it is extremely difficult to weaponize these agents effectively even 
with a national effort. The real reason scientists work with these 
agents and other dangerous infectious viruses and toxins and send them 
from one lab to another is for public health purposes: to identify and 
protect us from epidemics of infectious diseases that have and still do 
sweep through various parts of the world. This is a greater and more 
certain threat than bioterrorism has ever been. Over 100,000 Americans 
every year die from infectious diseases, and $30 billion is spent in 
direct treatment expenses.
    Most of the people who have died from laboratories' handling of 
these agents and other infectious materials in the United States have 
been the dedicated workers in university and private laboratories who 
are accidentally infected while doing this vital research. On the other 
hand, the crimes involving these agents have not been by terrorists but 
by laboratory personnel attempting to infect their personal enemies.
    How real is the threat? Many experts believe that no terrorist 
today has the expertise to develop and effectively disseminate 
bioweapons. We know it is difficult enough to require concerted 
national efforts by trained scientists to develop the agents used and 
more importantly design effective delivery systems. As staff was told 
by the Federal Bureau of Investigations this week, Russia employed 
600,000 people in its biological weapons program.
    The question then is whether we want to treat all of the 
laboratories doing non-military, disease research with these biological 
agents as weapons laboratories with the security and control that we 
provide our nuclear weapons laboratories. This Committee is very 
familiar with the security at the weapons laboratories. They are all 
federally controlled. They were constructed to be physically isolated 
and tightly guarded. There are many layers of physical security 
barriers to protect nuclear materials. Materials are heavily guarded 
and escorted when they leave the facilities. It can take months to 
arrange a shipment. Persons working with special nuclear materials and 
classified information have security clearances. No foreign nationals, 
even those with permanent residency, are allowed to work in these 
areas. The cumulative cost is in the billions of dollars.
    Is this what we want for every laboratory that works with special 
biological agents, usually for vaccine purposes? They were not built 
with that intent, and it would be extremely difficult to retrofit them 
to achieve that security level. And who will pay? What will the 
regulatory and inspection scheme be? Will the laboratories just drop 
the work because it is too burdensome to do?
    Some have suggested a regulatory and inspection scheme similar to 
that of the Nuclear Regulatory Commission for civilian nuclear power 
plants. But who will do it? The Centers for Disease Control, which has 
responsibility for implementing the shipping regulations, clearly does 
not want to do it. It is a premier public health research agency with 
no expertise in regulatory or law enforcement. The shipping regulations 
were the first this agency has ever issued. It also has a strong desire 
to keep paramount its collaborative scientific relationship with the 
laboratories and told us so in no uncertain terms in its submitted 
testimony. But yesterday someone removed those objections out of CDC's 
testimony, which we will talk about later. Should a new agency be set 
up specifically for this purpose? What role will the inspection agency 
play in the Biological Weapons Convention?
    My sense, Mr. Chairman, is that in the rush for action many have 
claimed credit, but no one has really thought these issues through.

    Mr. Upton. We are delighted to have this first panel with 
us today. They include Mr. Jim Reynolds, Chief of the Terrorism 
and Violent Crime Section of the Criminal Division of the 
Department of Justice; Mr. Robert Burnham, Chief of Domestic 
Terrorism Section from the National Security Division of the 
FBI; Dr. Bill Raub, Deputy Assistant Secretary for Science 
Policy from HHS, and Dr. Stephen Ostroff, Associate Director of 
Epidemiologic Science from the National Center for Infectious 
Disease of the Centers for Disease Control and Prevention.
    Gentlemen, we have a longstanding rule as part of this 
subcommittee that it is our practice to have you testify under 
oath. Do any of you have an objection to that?
    Under the rules of the house, each of you is entitled, if 
you wish, to be advised by counsel. Do any of you wish to be 
advised by counsel?
    Good. In that case, if you will please rise and raise your 
right hand.
    [Witnesses sworn.]
    You are now under oath. Your statements are made part of 
the record. We would like to limit your opening testimony to 5 
minutes. I have this little egg timer, here, that you will be 
able to watch. Mr. Reynolds, we will start with you. Thank you 
for being here this morning.

 TESTIMONY OF JAMES S. REYNOLDS, CHIEF, TERRORISM AND VIOLENT 
CRIME SECTION, CRIMINAL DIVISION, DEPARTMENT OF JUSTICE; ROBERT 
    M. BURNHAM, CHIEF, DOMESTIC TERRORISM SECTION, NATIONAL 
SECURITY DIVISION, FEDERAL BUREAU OF INVESTIGATION; WILLIAM F. 
RAUB, DEPUTY ASSISTANT SECRETARY FOR SCIENCE POLICY, DEPARTMENT 
  OF HEALTH AND HUMAN SERVICES; STEPHEN M. OSTROFF, ASSOCIATE 
   DIRECTOR FOR EPIDEMIOLOGIC SCIENCES, NATIONAL CENTER FOR 
     INFECTIOUS DISEASES, CENTERS FOR DISEASE CONTROL AND 
PREVENTION; ACCOMPANIED BY JONATHAN RICHMOND, DIRECTOR, OFFICE 
     OF HEALTH AND SAFETY, CENTERS FOR DISEASE CONTROL AND 
                           PREVENTION

    Mr. Reynolds. Thank you, Mr. Chairman, and good morning. I 
welcome the opportunity of joining with you this morning on 
behalf of the Department of Justice in this important hearing.
    There is a growing consensus emerging among law enforcement 
officials 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 a number of academics 
and healthcare professionals.
    One expert in the field has suggested that of all of the 
weapons of mass destruction, it is biological weapons that are 
the ones most feared. Yet, they are the ones that the United 
States is, in the judgment of that official, least prepared to 
deal with. Similarly, an HHS official has advised a 
congressional committee recently that a bioterrorist event is 
different from all other forms of terrorism in its potential to 
precipitate behavioral responses such as panic, civil disorder, 
and pandemonium.
    At the end of December of last year, the Attorney General 
sent to Congress a 5-year, counter-terrorism and technology and 
crime plan. In that plan, there was reference to the fact that 
intelligence information suggests growing interests by 
terrorists--both within the United States and abroad--to 
explore the potential use of biological weapons. This growing 
interest is reflected, also, in the increase in the number of 
investigations in this area that the Bureau is conducting. Mr. 
Burnham will address that later.
    The potential for mass casualties in the event of a 
terrorist act committed with biological agents underscores the 
critical need to prevent such acts. HHS has advised a House 
committee that 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. As a 
Government, we are spending vast sums on preparing for response 
to an eventual weapons of mass destruction attack. While those 
efforts are critically needed, the most effective way to 
counter the potential of bioterrorism is to prevent it.
    As you know, the President announced last week that his 
crime bill would include provisions relating to possession of 
biological agents. More specifically, the lead line of items in 
the bill--which is undergoing finishing touches at this point, 
and will be transmitted to Congress soon--includes possession 
of biological agents where that possession is not justified for 
a peaceful purpose; unsafe handling of biological agents with 
conscious disregard for public health and safety; unregistered 
possession of select agents; knowingly perpetrating a hoax 
regarding biological agents, and possession of select agents by 
restricted individuals.
    Under current law, we have two provisions that are key to 
addressing biological terrorism. We have 18 U.S.C. 175, which 
addresses possession of biological agents for use as a weapon; 
and we have 18 U.S.C. 2332(a), which addresses the use of 
biological weapons. However, by the time that biological 
material is weaponized, it may well be too late to prevent the 
weapons from being used and to prevent an attack of potentially 
catastrophic proportions.
    When the Attorney General testified, approximately a year 
ago, before Senate committees, she mentioned the need for a 
focus on the potential for additional legislation in this area. 
She advised those committees that we recognize that any 
criminal statutes that might be enacted to address this concern 
will require a careful balance between safety and the 
requirements of legitimate scientific researchers, on whom we 
are dependent for medical and technological advances. However, 
when a person who lacks requisite scientific training, or who 
has demonstrated record of irresponsible conduct possesses 
highly lethal substances for which they have no legitimate use, 
there is a clear public safety concern.
    Following that statement by the Attorney General, we have 
worked with HHS for the past year to try to tailor an incisive 
form of legislation that will balance the law enforcement need 
with the needs of the medical and scientific communities. We 
believe that balance can be achieved. Together with HHS, we 
look forward to working with the Congress and the private 
sector scientific community to achieve successful legislation. 
Thank you, Mr. Chairman.
    [The prepared statement of James S. Reynolds follows:]
 Prepared Statement of James S. Reynolds, Chief, Terrorism and Violent 
 Crime Section, Criminal Division, United States Department of Justice
    I am James S. Reynolds, Chief of the Terrorism and Violent Crime 
Section of the Criminal Division, United States Department of Justice. 
It is my pleasure to appear before you today to discuss the existing 
federal statutes relating to dangerous biological agents and toxins and 
possible statutory improvements designed to facilitate law enforcement 
in preventing potentially catastrophic acts of terrorism utilizing such 
agents.
    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.
    Dr. D. A. Henderson, Director of the Johns Hopkins Center for 
Civilian Biodefense Studies, recently 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, Education and 
Related Services of the Senate Committee on Appropriations, Hearing on 
Bioterrorism (March 16, 1999).
    Similarly, Dr. Margaret A. Hamburg, Assistant Secretary for 
Planning and Evaluation of the Department of Health and Human Services 
recently 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).
    The Five-Year Interagency Counter-Terrorism and Technology Crime 
Plan which the Attorney General submitted to Congress on December 31, 
1998, noted that there is increasing intelligence of interest by 
terrorists in the use of biological weapons both in the United States 
and abroad. 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 few years 
involving biological agents and toxins, including hoaxes and threats 
involving such materials.
    The potential for mass casualties in the event of a terrorist act 
committed with biological agents underscores the critical need to 
prevent such attacks. As Dr. Hamberg noted in her March 25, 1999, 
testimony before a House subcommittee, ``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.''
    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. To facilitate that 
paramount objective, improvements to existing federal statutes are 
needed. That is why the President announced last week that his 21st 
Century Crime Bill will:
        strengthen our efforts to combat international crime and 
        terrorism. The threat of weapons of mass destruction is real, 
        and increasing in an age of technological change and open 
        borders. The bill will make it a federal crime to possess the 
        biological agents used in such weapons without a legitimate 
        peaceful purpose.
More specifically, the crime bill, which is currently undergoing some 
finishing touches and will be transmitted to Congress soon, will keep 
dangerous biological agents and toxins out of the wrong hands by 
establishing criminal penalties for:

--possession of biological agents not justified by a peaceful purpose;
--unsafe handling of biological agents with conscious disregard for 
        public health and safety;
--unregistered possession and unauthorized transfer of select agents;
--knowingly perpetrating a hoax regarding biological agents; and
--possession of select agents by restricted individuals.
    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. Similarly, 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.
    While these statutes are of value to law enforcement, they require 
a close nexus between the possession of a biological agent and its use 
as a weapon. However, 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.
    When the Attorney General testified on April 22, 1998, before the 
Senate Select Committee on Intelligence and the Subcommitee on 
Technology, Terrorism and Government Information of the Senate 
Judiciary Committee, she noted that mere possession of a biological 
agent, without proof of its intended use as a weapon, is not a crime 
under federal law, notwithstanding the existence of factors which raise 
serious questions concerning the individual's ultimate reason for 
possessing the agent. The Attorney General went on to state that:
          We recognize that any criminal statutes which might be 
        enacted to address this concern will require a careful balance 
        between public safety and the requirements of legitimate 
        scientific researchers on whom we are dependent for medical and 
        technological advances. However, when a person who lacks the 
        requisite scientific training or who has a demonstrated record 
        of irresponsible conduct possesses a highly lethal substance 
        for which he has no legitimate use, there is a clear public 
        safety concern.
    Consistent with these statements by the Attorney General, the 
Department has worked closely during the past year with representatives 
of the Department of Health and Human Services and other components of 
government to develop the legislative proposals contained in the crime 
bill. I will review briefly some of our areas of focus. It should be 
stressed, however, that the objective throughout has been to facilitate 
the efforts of law enforcement in preventing acts of bioterrorism while 
respecting the needs of legitimate scientific researchers to have 
access to biological agents and toxins.
    Last October, Congress enacted the Chemical Weapons Convention 
Implementation Act which prohibits the possession of toxic chemicals 
and their precursors, unless they are held for legitimate purposes. We 
believe that this approach is appropriate as well in the context of 
biological agents. It is important that criminal law reach possession 
where, under the circumstances, the type or quantity of the biological 
agent or toxin possessed is inconsistent with peaceful purposes.
    Moreover, a statutory approach directed at unjustifiable possession 
should encompass both select (highly lethal) agents as well as other 
harmful agents. The select agents designated by the Centers for Disease 
Control do not encompass all lethal agents; moreover, nonlethal agents 
may cause widespread and serious injury. This is demonstrated by a 
recent case in Texas where a hospital laboratory technician spread 
shigella over donuts causing nineteen individuals to become ill. 
Similarly, in a well-known 1985 Oregon case, members of a cult spread 
salmonella over restaurant salad bars causing serious illness to 
hundreds of individuals. Neither of the agents involved is on the CDC 
select agent list as, we are advised, they are not highly lethal and 
because they are widely and routinely handled by clinical and 
diagnostic laboratories.
    Another concern with the current regime, from a law enforcement 
perspective, relates to the potential that laboratories with inadequate 
safeguards will serve to allow terrorists and others with criminal 
intent to gain access to dangerous biological agents. This could be 
addressed through a reckless handling provision which would reach the 
reckless or unauthorized removal of agents from legitimate facilities 
and would allow law enforcement to take action against those who do so.
    Such a statutory provision would focus on those who, with conscious 
disregard of an unreasonable risk to public health and safety, handle 
biological agents or toxins in a manner which grossly deviates from 
accepted norms. Currently, no federal criminal penalties attach to such 
conduct. Such a provision would reach home laboratories operating with 
grossly inadequate or nonexistent safeguards of the kind police 
discovered in the 1997 Milwaukee case involving Thomas Leahy, who 
operated a basement laboratory containing various biological 
substances, including ricin, and in the 1992 case in which one of the 
members of the Patriots Council manufactured ricin in his basement.
    Negligence or accidental conduct would not be captured. Rather, to 
be covered, the conduct would have to be undertaken with conscious 
disregard of an unreasonable risk to public health and safety and in 
gross contravention of accepted norms. Such a measure would effectively 
complement the regulatory regime relating to safety and security.
    Another focus of the crime bill relates to current law and CDC 
implementing regulations, which require only registration of entities 
that transfer or receive select agents. Entities must report (subject 
to verification by inspection) that they meet certain bio-safety 
recommended practices in order to obtain and maintain a registration. 
As we have seen in recent cases, there are individuals who cultivate 
select agents, such as ricin, and are therefore outside the reach of 
the CDC regulation. The crime bill has a proposal to address this 
concern. The creation of a reporting requirement regarding possession 
of select agents would recognize that authorities should be aware of 
who is handling the most deadly biological agents. The Department of 
Justice is aware of CDC's concerns about adding this reporting function 
to its public health mission. The appropriate locus of this additional 
responsibility is under consideration within the Administration.
     Existing criminal statutes relating to biological agents also fail 
to effectively address hoaxes, an increasingly common occurrence. 
Current law requires evidence of a threat to use a biological weapon or 
a threat to develop or possess biological agents for use as a weapon. 
The FBI has seen a significant increase in the number of cases 
involving hoaxes, many of which do not fit neatly into the current 
statutory scheme because they do not constitute the type of threat 
addressed under existing law. We have therefore included in the crime 
bill a false reporting provision to address the types of cases law 
enforcement is increasingly encountering.
     In addition, as the Attorney General has previously noted, there 
may be specific factors that raise questions regarding the suitability 
of an individual to possess deadly biological agents and that should 
prompt special scrutiny before such possession is permitted.
    These are generally the types of measures which would improve the 
ability of law enforcement to prevent dangerous biological substances 
from falling into the wrong hands and afford law enforcement an 
essential edge in preventing biological terrorism by allowing early 
intervention in the sequence of events leading to such catastrophic 
acts.
    At the same time, as the Attorney General noted in her April 22, 
1998, testimony, any legislative proposal should pursue a highly 
tailored approach which is minimally intrusive on the legitimate 
research community. As we have examined these issues, the Attorney 
General's admonition in this regard has served as a guiding principle. 
We believe that it is possible to enhance federal law in the interest 
of public safety while not impairing legitimate scientific endeavors, 
including important research on measures to counter bioterrorism. We 
recognize, however, that it is no simple task to craft legislation that 
successfully achieves both of these objectives, and that, in addition 
to the involvement of the Department of Health and Human Services, it 
is also important to involve the medical, scientific, and research 
communities.
     Among the substances that comprise potential weapons of mass 
destruction, our laws leave us most vulnerable in the area of 
biological weapons. While bioterrorism may be low volume, it has 
potentially enormously high consequences. The President's proposed 
crime bill will prepare us not only to respond to a completed act, as 
is occurring under the Nunn-Lugar-Domenici Amendment to the DOD 
Appropriations Act for FY97, but also to employ every effort to prevent 
the occurrence of such an act. Law enforcement action under the 
measures we have been involved in developing might prove to be 
infrequent but, when needed, the availability of effective measures 
could be the difference between prevention and catastrophic 
consequences.
    Thank you for the opportunity to appear before you today. I will 
now be pleased to respond to any questions that you may have.

    Mr. Upton. Thank you, Mr. Reynolds.
    Mr. Burnham.

                 TESTIMONY OF ROBERT M. BURNHAM

    Mr. Burnham. Good Morning, Mr. Chairman and members of the 
subcommittee. I would like to thank you for the opportunity to 
speak to you this morning.
    I am here primarily to discuss the law enforcement concerns 
regarding existing Federal statutes, particularly as they 
pertain to the threatened use and possession of biological 
agents. We believe these existing statutes have significant 
gaps, which the President will propose to fill when he submits 
his crime bill to Congress.
    Our response to these threats is constantly evolving. Over 
the last several years our knowledge and experience in this 
area has expanded tremendously. The large number of cases we 
have addressed over the last 3 years has highlighted certain 
vulnerabilities in the current legislation, which could 
significantly hamper future investigations.
    Weapons of mass destruction-type cases, primarily those 
cases dealing with the threatened use or procurement of 
chemical and biological materials with intent to harm, has 
steadily increased. I cited the numbers--I will not go through 
them here--in my written statement, which I have provided to 
the committee.
    Of concern, however, is that fact that under existing 
Federal statutes, there is no prohibition on any individual 
possessing any biological agents, regardless of the lethality 
or whether the individual has a legitimate use for the agents. 
A brief discussion of several cases will serve to highlight 
these concerns.
    The case involving Larry Wayne Harris garnered national 
attention, based upon his interest in biological weapons 
agents. In 1995, Harris ordered three vials of Yersinia pestis 
from a culture company. This is the causal agent for bubonic 
plague. After the vials were sent to Harris, he called to 
inquire about them from the company from which he ordered the 
vials, and the company became suspicious. After consulting with 
the Centers for Disease Control and Prevention, law enforcement 
was contacted and the vials were recovered from the glove 
compartment of Harris' vehicle.
    Although Harris claimed to be a microbiologist who was 
writing a training manual for the Aryan Nations, he certainly 
did not have the facility, or the training, necessary to 
properly handle the material. However, he had broken no law in 
possessing the agent, nor in maintaining it in his glove 
compartment. Ultimately, he was charged under the Fraud by Wire 
statute for fraudulently using a laboratory registration number 
when ordering the agent. A misdemeanor would exist today for 
such conduct under CDC transfer regulations.
    An individual by the name of Thomas Leahy came to the 
attention to the FBI in 1997, when he was arrested for shooting 
his stepson in the face. In basement of Leahy's home was a 
makeshift laboratory, where field tests indicated that he had 
produced ricin. Leahy was initially indicted for the possession 
of the biological agent ricin for use as a weapon, in violation 
of title 18, section 175, of the Biological Weapons and Anti-
Terrorism Statute, or ``BWAT.'' After further laboratory 
analysis, it was determined that he was growing botulism, and 
had produced nicotine sulfate which he mixed with DMSO, a 
solvent, and placed into a spray bottle. As the case 
progressed, it became apparent that proving that he intended to 
use the ricin as a weapon would be difficult. It was only after 
a superseding indictment for the weaponization of the nicotine 
sulfate, that Leahy agreed to plead guilty to violation of the 
BWAT statute. Until evidence developed regarding the 
weaponization of the nitrate sulfate, there was no clear basis 
for a successful prosecution.
    In another case, in 1995, an individual by the name of 
Thomas Lavy entered into Canada from Alaska on his way to North 
Carolina. Lavy was stopped by Canadian customs officials who 
discovered in his vehicles guns, a significant amount of cash, 
and white-supremacist literature. Also discovered was a 
container of white powder, which Lavy readily identified as 
ricin. The Canadians took the powder and released Lavy. 
Sometime later, the FBI was advised of the incident by the 
Canadian authorities.
    In the interest of public safety, an investigation was 
initiated. Lavy was subsequently arrested, and a search of his 
home conducted. Lavy was in possession of a large quantity of 
castor beans, from which ricin is derived, but stated that he 
had not produced more ricin. Under law at that time, he had 
perpetrated no clear threat. Consequently, the mere possession 
of the ricin was not, in and of itself, a violation of Federal 
law.
    Finally, in 1995, four members of the Patriots Council, an 
extremist group with anti-Government, anti-tax ideals that 
advocated the overthrow of the U.S. Government, were arrested 
for plotting to kill a U.S. Marshall with ricin. They had 
produced the ricin in a home laboratory, and planned to mix the 
ricin with DMSO, a solvent which they then would smear on the 
door handles of the Marshall's vehicle. The plan was thwarted, 
however, and the four men were convicted. The FBI was able to 
discover and prove their plan to use the ricin as a weapon. 
Again, had the subjects' threat to murder the Marshall with 
ricin not been discovered, the outcome of the case may have 
been different.
    If possession of this biological agent without a legitimate 
purpose were illegal, individuals acting in instances such as 
this could be thwarted prior to the development of proof of the 
intended or actual use of the agent as a weapon.
    In addition, as you are all aware, there has been a rash 
threats around the country involving anthrax. These threats 
have affected businesses, schools, hospitals, and even 
courthouses The cost of the responses to these threats is 
significant. For example, Los Angeles estimated that the cost 
to respond to the onslaught of threats it received around the 
New Year in 1999 was $1.5 million. Fortunately, the redirection 
of these emergency responses did not have an adverse effect on 
the Los Angeles' area ability to respond to these crises.
    I could cite numerous other examples where time and 
resources were expended in response to these threats. I 
believe, however, the cases aptly illustrate why passage of 
effective legislation addressing threat and false reporting of 
information regarding biological agents is imperative as a 
deterrent to the massive outlay of money and resources needed 
to respond to these bogus threats. To date, most of these 
threats have involved specific communicated threats to use a 
biological agent. Fortunately, we have not as yet had a major 
incident involving the actual release of a biological agent, 
such as anthrax.
    Several cases, however, have involved vague or veiled 
threats stating only that anthrax had been released. In 
addition, others have involved callers who have merely advised, 
in an apparent non-threatening manner, that anthrax had been 
released. The net effect has been highly disruptive for the 
responding community. Under existing legislation regarding 
biological weapons, there must be an actual threat to use these 
agents as a weapon to be considered a violation. Individuals 
that have caused these mass disruptions could potentially evade 
prosecution by claiming they had not communicated a threat to 
use a biological agent as a weapon. This issue has already been 
raised by the courts. We believe that a provision criminalizing 
false reporting requirement would remedy weaknesses in current 
law.
    Again, I thank the committee for allowing me to testify 
today. I am available for any questions you may have.
    [The prepared statement of Robert M. Burnham follows:]
  Prepared Statement of Robert M. Burnham, Chief, Domestic Terrorism 
                Section, Federal Bureau of Investigation
    Good morning Mr. Chairman and Members of the Subcommittee, my name 
is Robert M. Burnham, and I am the Chief of the Domestic Terrorism 
Section at FBI Headquarters. My current responsibilities include 
national oversight and management of the Domestic Terrorism Operations, 
Weapons of Mass Destruction and Special Events Management Programs for 
the FBI. Thank you for this opportunity to speak to you this morning 
about the Threat of Bioterrorism in America. I am here primarily to 
discuss the law enforcement concerns regarding existing Federal 
statutes, particularly as they pertain to the threatened use and 
possession of biological agents. We believe that these existing 
statutes have significant gaps, which the President will propose to 
fill when he submits his Crime Bill to Congress.
    Our response to these threats is constantly evolving and over the 
last several years our knowledge and experience in this area have 
expanded tremendously. The large number of cases we have addressed over 
the last three years has highlighted certain vulnerabilities in the 
current legislation which could significantly hamper future 
investigations.
    Weapon of Mass Destruction (WMD) type cases, primarily those cases 
dealing with the threatened use or procurement of chemical and 
biological materials with intent to harm, have steadily increased. In 
1996, 37 cases were opened by the FBI. In 1997, there were 74 cases 
opened, of which 22 were related to biological agents. By 1998, the FBI 
opened 181 cases, 112 of which were biological in nature. In 1999 there 
have been 123 WMD cases, 100 of which have been biological. In 1998 and 
1999 combined, over three-quarters of the cases opened have threatened 
a biological release, and the biological agent most often cited in 1998 
and 1999 has been anthrax.
    Of concern is the fact that under existing federal statutes, there 
is no prohibition on any individual possessing any biological agents 
regardless of their lethality or whether the individual has a 
legitimate use for the agents. A brief discussion of several cases will 
serve to highlight these concerns.
     The case involving Larry Wayne Harris has garnered national 
attention based upon his interest in biological weapons agents. In 
1995, Harris ordered three vials of Yersinia pestis from a culture 
company. Yersinia pestis is the causal agent for bubonic plague. After 
the vials were sent Harris called to inquire about them and the company 
from which he ordered the vials became suspicious. After consulting 
with the Centers for Disease Control and Prevention(CDC), law 
enforcement was contacted and the vials were recovered from the glove 
compartment of Harris's vehicle. Although Harris claimed to be a 
microbiologist who was writing a training manual for the Aryan Nations, 
he certainly did not have a facility or the training necessary to 
properly handle the material. However, he had broken no law in 
possessing the agent, or in maintaining it in his glove compartment. In 
fact he was ultimately charged under the Fraud by Wire statute for 
fraudulently using a laboratory registration number when ordering the 
agent. A misdemeanor would exist today for such conduct under CDC 
transfer regulations.
    An individual by the name of Thomas Leahy came to the attention of 
the FBI in 1997 when he was arrested for shooting his stepson in the 
face. In the basement of Leahy's home was a makeshift laboratory where 
field tests indicated that he had produced ricin. Leahy was initially 
indicted for possession of the biological agent ricin for use as a 
weapon in violation of Title 18, Section 175, the Biological Weapons 
Anti-Terrorism Statute (BWAT). After further laboratory analysis it was 
also determined that he had attempted to grow botulism and had produced 
nicotine sulfate which he mixed with DMSO, a solvent, and placed in a 
spray bottle. As the case progressed it became apparent that proving 
Leahy intended to use the ricin as a weapon would be difficult. It was 
only after a superseding indictment for the weaponization of the 
nicotine sulfate that Leahy agreed to plead guilty to a violation of 
the BWAT Statute. Until evidence developed regarding weaponization of 
the nitrate sulfate, there was no clear basis for successful 
prosecution.
    In another case in 1995, an individual by the name of Thomas Lavy 
entered into Canada from Alaska on his way to North Carolina. Lavy was 
stopped by Canadian Customs officials who discovered in his vehicle 
several guns, $98,000.00 in cash and white supremacist literature. Also 
discovered was a container of white powder which Lavy readily 
identified as ricin. The Canadians took the powder, and released Lavy. 
Sometime later, the FBI was advised of the incident by Canadian 
authorities and in the interest of public safety an investigation was 
initiated. Lavy was subsequently arrested and a search of his home 
conducted. Lavy was in possession of a large quantity of castor beans, 
from which ricin is derived, but stated that he had not produced more 
ricin. Lavy committed suicide while in a detention facility awaiting 
adjudication. He had perpetrated no clear threat; the mere possession 
of the ricin was not itself a violation of federal law.
    In 1995, four members of the Patriots Council, an extremist group 
with anti-government and anti-tax ideals that advocated the overthrow 
of the U.S. Government, were arrested for plotting to kill a U.S. 
Marshal with ricin. They had produced the ricin in a home laboratory 
and planned to mix the ricin with DMSO, a solvent, which they would 
then smear on the door handles of the Marshal's vehicle. The plan was 
thwarted, however, and the four men were convicted. The FBI was able to 
discover and prove their plan to use the ricin as a weapon. Again had 
the subjects threat to murder the Marshal with ricin not been 
discovered, the outcome of the case may have been different. If 
possession of this biological agent without a legitimate purpose were 
illegal, individuals acting in instances such as this could be thwarted 
prior to the development of proof of the intended or actual use of the 
agent as a weapon. Merely possessing this biological agent, without 
intent to use it as a weapon, would not have constituted any crime 
under existing federal law.
    As you are all aware, there has been a rash of threats around the 
country involving anthrax. These threats have affected businesses, 
schools, hospitals, and even court houses. The cost of the response to 
these threats is significant. For example, Los Angeles estimated that 
the cost to respond to the onslaught of threats they received around 
the New Year in 1999 was one and a half million dollars. Fortunately, 
the redirection of these emergency response assets did not have an 
adverse effect on the Los Angeles area's ability to respond to other 
crises. The arrest of two individuals involved in making threats in 
California was well publicized, and as a result of those arrests there 
was an immediate drop in the number of threats received throughout 
California. However the frequency of these threats still has the 
potential to desensitize people to the possibility of an actual attack 
and is of concern.
    I could cite numerous other examples where time and resources were 
expended in response to these threats. I believe this aptly illustrates 
why passage of effective legislation addressing threat and false 
reporting of information regarding biological agents is imperative as a 
deterrent to the massive outlay of money and resources needed to 
respond to these bogus threats. To date, most of these cases have 
involved specific communicated threats to use a biological agent. 
Fortunately, we have not as yet had a major incident involving the 
actual release of a biological agent such as anthrax. Several cases 
have involved vague or veiled threats stating only that anthrax had 
been released. In addition, others have involved callers who have 
merely advised in an apparent non-threatening manner that anthrax had 
been released in the building. The net effect has been highly 
disruptive for the responding community. Under existing legislation 
regarding biological weapons, there must be a threat to use these 
agents as a weapon to be considered a violation. The individuals who 
have caused these mass disruptions could potentially evade prosecution 
by claiming they had not communicated a threat to use the biological 
agent as a weapon. This issue has already been raised by the courts. We 
believe that a provision criminalizing false reporting requirement 
would remedy weaknesses in current law.
    As I have stated previously, the interest in biological agents and 
weapons continues to grow. Intelligence has indicated that terrorist 
groups, both foreign and domestic, have demonstrated an interest in 
acquiring biological materials and knowledge. In addition, literature 
containing recipes and modes of dissemination are available through 
``how to'' literature and over the Internet. Whether the cases involve 
mere threats or actual possession of biological material, the 
disruption and potential damage to the public is potentially 
devastating. New legislation is needed to adequately support the agents 
and prosecutors who work to protect the public from those who would 
misuse biological agents as a weapon, and those who capitalize on the 
fear and panic that can be derived from the mere threat of a biological 
attack. The President's proposed Crime Bill will address these needs.
    Thank you for you consideration today, and I will answer any 
questions you may have.

    Mr. Upton. Thank you very much.
    Dr. Raub.

                  TESTIMONY OF WILLIAM F. RAUB

    Mr. Raub. Thank you, Mr. Chairman. My colleagues and I at 
the Department of Health and Human Services welcome your 
interest in deterring would-be terrorists from using hazardous 
biological materials to harm the civilian population and create 
widespread civil unrest.
    Dr. Ostroff from the Centers for Disease Control and 
Prevention will describe the activities of that agency in 
regulating the transfer of certain hazardous organisms and 
toxins, otherwise known as ``select agents,'' between 
facilities that require them for various research, testing, or 
educational purposes. I will present the HHS perspective 
regarding further steps that might be taken to prevent 
biological terrorism.
    During the past year, the Department of Justice has been 
leading an effort within the executive branch to examine 
current statutes related to terrorist or other criminal use of 
hazardous biological materials; to identify needs for new 
criminal provisions that might deter such actions, and to 
develop legislative proposals to meet those needs. HHS staff 
have participated in the interdepartmental discussions.
    As the President indicated in his statement last week, he 
plans to send a broad-ranging crime bill to the Congress in the 
near future. That bill is to include proposals related to 
hazardous biological materials and biological weapons. Specific 
candidate provisions now are under consideration by the 
President and his senior advisors.
    The principal concerns within the executive branch that led 
to the development of those provisions are as follows: one, 
although transfer of select agents between facilities is 
regulated through Part 72 of Title 42 of the Code of Federal 
Regulations, the current rule does not cover possession by 
facilities or individuals when no transfer is involved. Two, 
individuals who possess hazardous biological materials of a 
type or in a quantity not justified by a peaceful purpose are a 
danger to society. Current statutes are insufficient to 
discourage such behavior. Three, an analogous concern about 
danger to society and limitations of current statutes exists 
with regard to individuals who handle hazardous biological 
materials knowingly, recklessly, and in conscious disregard of 
public health and safety.
    Four, a hoax or other false report regarding hazardous 
biological materials warrants either criminal or civil penalty, 
commensurate with the nature of the act. Five, the question of 
who should have access to select agents in research in public 
health laboratories requires careful attention. Research with 
select agents is, and must continue to be, an integral part of 
our anti-bioterrorism strategy. The challenge is to effect 
appropriate protections against misuse of select agents, while 
ensuring the strong, sustained program of research that 
enhanced national security demands.
    My HHS colleagues and I look forward to release of the 
President's legislative proposals and the ensuing discussions 
with the Congress, the scientific and public health 
communities, and the general public. We are prepared to 
contribute to those discussions to the best of our ability. 
Thank you, Mr. Chairman.
    [The prepared statement of William F. Raub follows:]
 Prepared Statement of William F. Raub, Deputy Assistant Secretary for 
  Science Policy, Office of the Assistant Secretary for Planning and 
    Evaluation, Office of the Secretary of Health and Human Services
    Thank you, Mr. Chairman. My colleagues and I at the Department of 
Health and Human Services (HHS) welcome your interest in deterring 
would-be terrorists from using hazardous biological materials to harm 
the civilian population and create widespread civil unrest. Dr. Ostroff 
of the Centers for Disease Control and Prevention will describe the 
activities of that agency in regulating the transfer of certain 
hazardous organisms and toxins (``select agents'') between facilities 
that require them for various research, testing, or educational 
purposes. I will present the HHS perspective regarding further steps 
that might be taken to prevent biological terrorism.
    During the past year, the Department of Justice has been leading an 
effort within the Executive Branch to examine current statutes related 
to terrorist or other criminal use of hazardous biological materials; 
to identify needs for new criminal provisions that might deter such 
actions; and to develop legislative proposals to meet those needs. HHS 
staff have participated in the inter-Departmental discussions. As the 
President indicated in a statement last week, he plans to send a broad-
ranging crime bill to the Congress in the near future. That bill is to 
include proposals related to hazardous biological materials and 
biological weapons. Specific candidate provisions now are under 
consideration by the President and his senior advisors.
    The principal concerns within the Executive Branch that led to the 
development of those provisions are as follows:
    1. Although transfer of select agents between facilities is 
regulated (Part 72 of Title 42 of the Code of Federal Regulations), the 
current rule does not cover possession by facilities or individuals 
when no transfer is involved.
    2. Individuals who possess hazardous biological materials of a type 
or in a quantity not justified by a peaceful purpose are a danger to 
society, but current statutes are insufficient to discourage such 
behavior.
    3. An analogous concern about danger to society and limitations of 
current statutes exists with regard to individuals who handle hazardous 
biological materials knowingly, recklessly, and in conscious disregard 
of public health and safety.
    4. A hoax or other false report regarding hazardous biological 
materials warrants either criminal or civil penalty commensurate with 
the nature of the act.
    5. The question of who should have access to select agents in 
research and public health laboratories requires careful attention. 
Research with select agents is and must continue to be an integral part 
of our anti-bioterrorism strategy. The challenge is to effect 
appropriate protections against misuse of select agents while ensuring 
the strong, sustained program of research that enhanced national 
security demands.
    My HHS colleagues and I look forward to release of the President's 
legislative proposals and the ensuing discussions with the Congress, 
the scientific and public health community, and the general public. We 
are prepared to contribute to those discussions to the best of our 
ability.

    Mr. Upton. Thank you. Extra bonus for not having this thing 
ring [referring to timer].
    Dr. Ostroff.

                 TESTIMONY OF STEPHEN M. OSTROFF

    Mr. Ostroff. Hopefully, I won't take more than a minute or 
2 of his time. Thank you, Mr. Chairman. Let me point out that I 
am joined by Dr. Jonathan Richmond, who is Director of CDC's 
Office of Health and Safety.
    We are pleased to have the opportunity to describe CDC's 
role in regulating the shipment of select agents which have the 
potential to cause substantial harm to human health. Along with 
the other agencies represented at this hearing, CDC and its 
partners in the public health community share concerns about 
the growing threat of the use of biologic agents by individuals 
and groups for illegitimate purposes.
    It should be noted that, in general, the safety record of 
the shipment of these agents for research has been good. Each 
year in this country, thousands of samples of infectious agents 
are shipped without incident. Shipment of these agents between 
medical and research facilities is essential to advance medical 
research and to aid in the diagnosis and treatment of 
infectious diseases.
    Historically, CDC has been responsible for providing 
guidance to the research and medical community about how to 
safely package and ship biohazardous materials. The 
Antiterrorism and Effective Death Penalty Act of 1996 required 
the Secretary of Health and Human Services to promulgate new 
regulations expanding CDC's traditional role by placing 
additional controls on the shipment of select agents that could 
be used for bioterrorist purposes. In response to this mandate, 
and acting from our perspective as a public health agency, CDC 
set about the task of developing regulation which would balance 
the need for appropriate safeguards, without unduly restricting 
the legitimate scientific and research community from working 
with these agents.
    This community encompasses governmental agencies, academic 
centers, and private entities, which include the pharmaceutical 
industry and research laboratories. In developing and 
implementing the regulations, CDC worked extensively with our 
traditional scientific and public health partners, and with 
non-traditional partners in the relevant law enforcement 
agencies. We did so, even as we recognized that such a 
regulatory role for CDC would adversely impact the longstanding 
working relationship with many of our partners.
    Since implementation of the regulation through May 17 of 
this year, a total of 123 facilities have submitted 
applications and been registered with CDC to ship or receive at 
least one of the microbes or toxins on the select agents list. 
Approximately 41 percent of these facilities are academically 
based; 23 percent are governmental, and 36 percent are private 
or commercial entities. Cumulatively, these facilities have 
informed CDC of almost 700 transfers, all of which have 
occurred without incident.
    CDC continues to receive approximately five new 
applications per month to register as a select agent shipping 
facility. The application process requires facilities to go 
through a checklist which establishes whether the facility 
needs to be registered, and then to submit information 
demonstrating that the appropriate standards are in place to 
ensure agents can be handled in a safe manner. This is the 
application packet.
    The standards are based on the CDC/NIH guidelines entitled, 
``Biosafety In Microbiologic and Biomedical Laboratories,'' or 
the ``BMBL.'' The third edition of the BMBL has been the 
version in use since the select agent regulation was developed. 
A new edition will be issued in the near future. This new 
edition contains a section on biosecurity, and explicitly 
informs users about the registration requirement for transfer 
of select agents.
    During the application review process there is repeated 
interaction between CDC and the applicant before a permit is 
issued. If there are any questions about the legitimacy of 
information conveyed on the forms, an inspection would be 
performed prior to issuance of the registration. CDC policy 
requires that each facility be inspected, at least once, over 
their 3-year registration period. To date, only 15 of the 123 
facilities have been inspected; but it is worth noting that the 
pace of inspection has picked up significantly over the last 
several months.
    The select agent rule is only one facet of CDC's activities 
to protect our Nation's health from the threat of bioterrorism. 
In keeping with its public health mission, CDC has now been 
given responsibility to work with our traditional partners to 
upgrade the public health infrastructure to meet this threat. 
In many instances, the partners that we work with are the same 
ones which we are required to regulate under the select agent 
rule.
    Significant gaps remain in our ability to prevent and 
mitigate bioterrorist incidents. These run the gamut from an 
unprepared public health community, to the need for criminal 
sanctions for inappropriate possession of biological agents for 
nefarious purposes. We are in full agreement that there is a 
need to close these gaps as rapidly and effectively as 
possible. We believe it is critical that any additional 
safeguards be balanced against other important concerns; 
notably, the need to support legitimate research involving 
these substances.
    Today there is a need to expand research involving select 
agents, not to constrain it. We must bring the best and 
brightest minds to bear on the development of better vaccines, 
antiviral agents, antibiotics, and other therapies for exposure 
to, or illness from, biological agents. To do so, we need to 
ensure that restrictions on possession or handling of 
biological agents do not have a chilling effect on the 
willingness of scientists and research establishments to take 
part.
    In conclusion, a strong and flexible public health 
infrastructure is the best defense against any disease 
outbreak, whether it is natural or intentional. Addressing the 
threat of bioterrorism requires an unprecedented level of 
cooperation and partnership, bringing together agencies with 
diverse missions. CDC fully supports criminal sanctions 
designed to capture and punish those who seek to, or do, 
possess any of these agents for nefarious purposes. However, 
these sanctions must be carefully developed to ensure that they 
do not unduly curb the research vitally needed to best prepare 
our Nation to respond effectively to a bioterrorist attack.
    Thank you very much for you attention. We will be happy to 
answer any questions that you have.
    [The prepared statement of Stephen M. Ostroff follows:]
   Prepared Statement of Stephen M. Ostroff, Associate Director for 
Epidemiologic Science, National Center for Infectious Diseases, Centers 
                   for Disease Control and Prevention
    Good morning. I am Dr. Stephen Ostroff, Associate Director for 
Epidemiologic Science, National Center for Infectious Diseases at the 
Centers for Disease Control and Prevention. I am pleased to be here to 
describe CDC's role in regulating the shipment of select agents that 
are capable of causing substantial harm to human health.
                      overview of cdc's 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. In general, the safety and security record in the 
sale and transfer of these agents and substances for research has been 
good. Each year in the United States, thousands of samples of 
infectious agents are shipped without incident. 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.
    Historically, 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 our partners in the scientific community to develop 
and implement the regulation, even though we believe the regulatory 
framework has adversely impacted the longstanding working relationships 
with some of these partners.
    The regulation placed additional shipping and handling requirements 
on facilities that transfer or receive select agents that are capable 
of causing substantial harm to 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 Department of Health and Human Services (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 infectious 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 the 
rule. 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 as a 
human or veterinary clinical specimen, 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 3rd 
edition of the CDC/NIH Biosafety in Microbiological and Biomedical 
Laboratories (BMBL). An updated version of the BMBL will be published 
soon. 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 federal 
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 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 10 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. However, 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 May 17, 123 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 500 
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 closely with FBI personnel to 
ensure that the FBI and other authorized law enforcement agencies have 
access to the information if necessary.
             cdc's role in addressing bioterrorist threats
    In the past year CDC has gained a greater responsibility to enhance 
our nation's public health capacity to respond to the threat of 
biological terrorism. A primary role of CDC is prompt detection of 
disease threats which are naturally occurring or intentional. This 
requires careful monitoring by effective disease surveillance systems, 
backed by the capacity to investigate and control outbreaks of a 
variety of health problems in a timely manner.
    As the nation's disease prevention and control agency, it is CDC's 
responsibility to provide national leadership in the public health and 
medical communities in a concerted effort to detect, diagnose, respond 
to, and prevent illnesses, including those that occur as a result of a 
deliberate release of biological or chemical agents. This task is an 
integral part of CDC's overall mission to monitor the health of the 
U.S. population.
    In 1998, CDC issued Preventing Emerging Infectious Diseases: A 
Strategy for the 21st Century, which describes CDC's plan for combating 
today's emerging diseases and preventing those of tomorrow. It focuses 
on four goals, each of which has direct relevance to preparedness for 
bioterrorism: disease surveillance and outbreak response; applied 
research to develop diagnostic tests, drugs, vaccines, and surveillance 
tools; infrastructure and training; and disease prevention and control. 
This plan emphasizes the need to be prepared for the unexpected--
whether it be a naturally occurring influenza pandemic or the 
deliberate release of anthrax by a terrorist. Copies of this plan have 
been provided to the Subcommittee.
            law enforcement and cdc's public health mission
    In this larger context of responding to bioterrorist threats, there 
are certain areas where further work is needed to develop appropriate 
safeguards against the threats to public health and safety presented by 
biological agents, toxins, and delivery systems.
    CDC 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
    In conclusion, a strong and flexible public health infrastructure 
is the best defense against any disease outbreak--naturally or 
intentionally caused. To meet the challenges posed by infectious 
diseases, including outbreaks that may result from bioterrorism, we 
must strengthen our capacity to detect and respond to infectious 
diseases. CDC's on-going initiatives to strengthen disease surveillance 
and response at the local, State, and Federal levels can complement 
efforts to detect and contain diseases caused by the biological agents 
that might be used as weapons. Addressing the threat of bioterrorism 
requires an unprecedented level of cooperation and partnership, 
bringing together agencies with diverse missions. These include public 
health and law enforcement agencies, civilian and military agencies, 
and public and private organizations. Finally, CDC 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.
    Thank you very much for your attention. I will be happy to answer 
any questions you may have.

    Mr. Upton. Thank you.
    The normal way that we do this is that each member gets 5 
minutes to get questions and answer back. If we need to go to a 
second round, we will. So, I get to start.
    I guess my first question is, as we begin to look at the 
administration's proposal as part of the new crime package that 
we expect in the near future, are all of you, certainly, your 
agencies, but are you, as individuals, part of the working 
group to try to come with the exact language in terms of the 
five proposals that are out there: the possession, unsafe 
handling, unregulated passage or transfer, the hoax, and the 
restricted individual language? Are each of you part of that 
discussion group?
    Mr. Reynolds. Mr. Chairman, I have been personally involved 
from Justice, along with some of the people that work in my 
section. We have interrelated since May of last year with CDC. 
I can give you the names of the people, if you are interested.
    We have also interrelated, more recently, with the General 
Counsel's Office of HHS, and with the Assistant Secretary's 
Office, from which Bill Raub comes. We consult with the FBI, as 
needed, for technical guidance on the law enforcement side. So, 
all of the components represented here have been involved in 
this process.
    Mr. Upton. Mr. Burnham?
    Mr. Burnham. Yes. A representative from my section, with 
the FBI, has been taking part with HHS, DOJ, and CDC in this, 
for some time now.
    Mr. Upton. Dr. Raub?
    Mr. Raub. Yes, Mr. Chairman. I have been part of some of 
the discussions with Mr. Reynolds, along with our General 
Counsel and other officials in the Office of the Secretary. As 
a scientist, I am not actually involved with drafting 
legislation, but have tried to contribute ideas toward the 
development of the goals and principles of this work.
    Mr. Ostroff. I think that my comments would be the same. 
Basically CDC has, indeed, been involved in the development of 
the language. I, specifically, have not been. Although, on some 
occasions I have been able to comment on some of the specific 
language.
    Mr. Upton. Do any of you have a sense as to when the work 
will be completed, and that part of the proposal will be ready 
to be sent up to the Hill?
    Mr. Reynolds. Our hope is that it will be in the very near 
future. There has been intensive effort.
    Mr. Upton. A couple of weeks?
    Mr. Reynolds. Since I don't control that process, I can't 
give you a specific timeframe. Certainly, we would be 
optimistic that it would be within the next couple of weeks.
    Mr. Upton. Does anyone disagree with that? One of the 
reasons that I thought this hearing was important is that I 
remember reading about the Harris case in Nevada. I was 
appalled, stunned, all those words that describe, certainly, my 
attitude about it. As I think about it, there really isn't, 
despite the work that is done, particularly with the CDC, a 
requirement out there at all that would show, if a transfer is 
being made, there is actually a loss with regard to shipment. 
Is that right? If a shipment was made from one company to an 
individual, is there any requirement at this point?
    Mr. Ostroff. Well, what the select rule stipulates is that 
both the shipper and the receiver must verify that the shipment 
has been sent, and that the shipment has been received. Within 
72 hours of the supposed time of receipt, the recipient must 
notify CDC of that receipt.
    Mr. Upton. How does it usually get shipped? What type of 
carrier, UPS or FedEx?
    Mr. Ostroff. There can be a variety of ways that these 
agents would be shipped. Some of the ways that you stated would 
be correct. They would be shipped through the mails; through 
courier; or in some cases, they would be hand-carried.
    Mr. Upton. I know in reading through the testimony and 
looking to the next panel, there seems like there is some 
disagreement with regard to the restricted individual: whether 
the individual should actually file some type of statement with 
regard whether they have been convicted of a felony, similar to 
what we have for guns, the Brady Bill. Are we close to 
resolving this between HHS, CDC and law enforcement?
    Mr. Reynolds. It is certainly our hope that it is near to 
resolution.
    Mr. Upton. Can you just comment, at all, and tell me where 
we are with regard to that regulation?
    Mr. Reynolds. I think all the issues have been identified. 
There has been a productive discussion. HHS has expressed its 
views. The Justice Department and FBI have expressed their 
views. The matter is ready for decision. We would anticipate 
that it will be resolved very quickly.
    Mr. Upton. Okay. Mr. Stupak.
    Mr. Stupak. Thank you, Mr. Chairman. There has been a lot 
focus, thus far, on law enforcement and crimes and things like 
that. I am sure that I don't have to remind anyone on the 
committee that as the Oversight and Investigation for Commerce 
Committee, we do not have jurisdiction over that aspect. That 
property lies with the Judiciary Committee.
    I am happy to go there, because my background is in law 
enforcement. I am very comfortable discussing law enforcement 
issues on what should and can be done. I think we have to watch 
our questions and discussion about where we do have 
jurisdiction, which are laboratories--Federal control over 
those labs.
    While there has been a lot of testimony about crimes and 
crime packages, we really don't have jurisdiction. So, I am 
going to try to limit my questions to where we do have some 
jurisdiction. I would like to go back to Dr. Ostroff on the 
regulations--the shipping. You mentioned UPS and Federal 
Express. Any courier can actually ship that stuff, for you, 
right?
    Mr. Ostroff. That is correct.
    Mr. Stupak. So are there any requirements, or guardians of 
these biological agents when they leave the laboratory and give 
it to UPS? Do you know who they are? Are they trained to handle 
it? Are they armed? How do you do it; just bring it down to 
your friendly shipper and let her go?
    Mr. Ostroff. Most of the requirements revolve around how 
the materials are packaged. That has traditionally been what 
CDC's involvement has been: to ensure that they are properly 
packaged so that they don't break; they don't open during 
shipment, et cetera. It has not been in the area of the 
security aspects of the package itself.
    Mr. Stupak. You package it up really well. UPS comes to the 
door to take your package, right? Do you check to see if he is 
UPS? Do you check to see if he has security clearance? Do you 
check to make sure he knows where it is going? Do you do any of 
that?
    Mr. Ostroff. Well, I personally can't speak to that.
    Mr. Stupak. Well I don't think that you personally do it, 
but someone in your agency?
    Mr. Ostroff. Jonathan, would you care to specifically 
answer that--if I could have Dr. Richmond to, since this is his 
particular area?
    Mr. Stupak. Sure.
    Mr. Richmond. The process at CDC is quite well controlled.
    Mr. Stupak. At CDC. I agree. I am going to leave CDC. I am 
going through the door. What controls it after it leaves my 
door?
    Mr. Richmond. None, that I am aware of.
    Mr. Stupak. The only other control on your pick-up is when 
it lands at University of Michigan laboratory. There is a 
check-in procedure there. So what happens between CDC and 
University Michigan? We have no controls, no rules, no 
regulations, or know who is even doing it. Is that correct?
    Mr. Richmond. That is correct.
    Mr. Stupak. Shouldn't we do something about that aspect, if 
we are concerned about it going in the wrong hands?
    Mr. Richmond. It is an area where I don't have expertise.
    Mr. Stupak. Mr. Reynolds, is there something we should do 
about that: the shippers and handlers after they leave the CDC 
and before it gets to the lab on the other end?
    Mr. Reynolds. Well, certainly we are concerned that it be a 
secure form of shipment. We are not particularly expert on the 
CDC regs. We do ship classified information by couriers, 
consistent with rules that exist within the executive branch. I 
think, certainly, it merits an examination of what the rules 
are concerning the forms of shipment.
    Mr. Stupak. But once it leaves CDC, it is not secure 
anymore, is it?
    Mr. Reynolds. Once it leaves the shipping entity, whatever 
the shipping entity is, it is proceeding by the packaging of 
whatever the authorized courier is. You are correct in the 
sense that it is not secure in the sense of an armed guard.
    Mr. Stupak. Yes, well, not even armed guards. These are 
just people that are handling it. It may go from--CDC is in 
Atlanta?
    Mr. Ostroff. Right.
    Mr. Stupak. It goes from Atlanta. It goes up to Nashville; 
switches planes--show the commercial--going overnight; people 
throwing it up onto the railing. It ends up at University of 
Michigan, 48 hours later. What happens in between, there is no 
security, right?
    Mr. Reynolds. From law enforcement we are concerned that 
there not be an opportunity for the loss of the material, or 
for criminals to obtain the material.
    Mr. Stupak. We are concerned, but there is nothing there to 
alleviate those concerns, currently.
    Mr. Reynolds. There is the CDC regulation process and the 
CDC oversight process. That is what is currently there.
    Mr. Stupak. But it doesn't cover that, does it? Once it 
leaves CDC, there is no rules or regulations. Correct?
    Mr. Reynolds. There is, in place, whatever CDC has put in 
place. That is all I can say.
    Mr. Stupak. Nothing?
    Mr. Ostroff. That is correct. As I mentioned, our 
regulations involve how it is packaged.
    Mr. Stupak. And after it is packaged, we are out of it.
    Mr. Ostroff. Right.
    Mr. Stupak. Thanks.
    Mr. Upton. Mr. Bilbray.
    Mr. Bilbray. Let us follow-up on that. The package, itself, 
is prepared for shipment. What is the labeling on the outside 
of the package? What does the courier see?
    Mr. Ostroff. There are biohazard stickers. It indicates 
``infectious agent.''
    Mr. Bilbray. So, the defense of stealth is not there, 
basically. Of course, it does not indicate what it is.
    Mr. Ostroff. Correct.
    Mr. Bilbray. The biohazard sticker could be anything from 
the shipment of material that has been taken from a cancerous 
liver to a biochemical agent? I am just saying that from my 
environmental health background, I know that even the waste 
from surgical operations are tagged as biowaste. The indicator 
is basically consistent?
    Mr. Ostroff. Yes.
    Mr. Bilbray. Okay. I think that biggest issue here that the 
gentleman from Michigan was looking at is that the security of 
stealth of somebody trying to intercept a shipment. First of 
all, they need to know what is in the shipment. There is so 
much of it going on, it could be anything. I mean, it could be 
somebody's kidney that is being sent out for laboratory 
testing. But the fact is, the lack of knowledge of what is in 
that shipment is probably the best defense based on a stealth 
approach.
    The danger is not so much physically securing the object, 
as much as securing the information on what that object is. 
What is the security of the information that is being 
transmitted between agencies and between groups? In other 
words, the information being sent to the University of Michigan 
is that on this day we are going to send you this product and 
it has anthrax in it. The question is: what kind of security do 
we have there? I hope that gentleman from Michigan understands 
where I see it coming.
    Mr. Ostroff. Well, again, the requirements stipulate that 
the shipper and the recipient have to communicate, ahead of 
time. Obviously, they would not be shipping it to the recipient 
unless there has been some sort of communication. There is a 
transfer document that gets received by the recipient 
indicating what will be shipped, and what they will be 
receiving. Again, the recipient must verify the validity of 
that information, as well as the content of the package. They 
also are, certainly, informed of who needs to be informed if 
there are any problems.
    Mr. Bilbray. Okay. I would say that I would see more 
threat--more security problems--from the information, than even 
the physical package, itself. There are so many packages flying 
around that if there isn't that information, it really is a 
needle in a haystack for anyone trying to intercept something 
that can be used. I would say, strongly, the information side 
may be the side that does not seem like a big deal up front, 
but may be considered that.
    In the other issue, you were talking about an individual 
who acquired the substance that was in the glove compartment of 
his car. How did he gain access to that again? Can you review 
that? Did he physically go in; sign for it, or did he have it 
shipped to him?
    Mr. Ostroff. It was shipped to him.
    Mr. Bilbray. Shipped to him. What documentation did he have 
to show? Did he have to show that he was over 21, or 18?
    Mr. Burnham. I believe I testified regarding this. I think 
he falsified whatever CDC has for a number. He had a false 
registration number. He sent it in and received it that way. 
That is why he was ultimately indicated under the Fraud by Wire 
statute.
    Mr. Bilbray. I am just questioning. One of the concerns we 
talk about is, you know, can my 14-year-old son get a weapon 
that might be able to be used? Even if it was a black-powder, 
antique pistol that fires one shot, there are certain 
procedures he has to go through.
    Mr. Ostroff. Congressman, if I could point out that that 
incident happened before the select agent rule came into force. 
That was actually the genesis of why the select agent 
requirements were developed. So, he didn't have a CDC 
registration number to be registered as a select agent, because 
the rule was not in place.
    Mr. Bilbray. Now we have that firewall?
    Mr. Ostroff. Correct.
    Mr. Bilbray. Thank you, very much. I yield back.
    Mr. Upton. Mr. Green.
    Mr. Green. Thank you, Mr. Chairman. I want to follow-up 
both my colleagues, Mr. Bilbray and Mr. Stupak. Dr. Ostroff, 
CDC has 11 centers around the country. How many regulations has 
CDC promulgated, to date, based on the shipping biomedical 
waste?
    Mr. Ostroff. Well, not waste specifically, but biological 
agents. This is the only regulation.
    Mr. Green. Okay, so one. With only one regulation, do you 
consider yourselves a law enforcement or inspection agency, 
like the Food and Drug Administration?
    Mr. Ostroff. No, sir.
    Mr. Green. I was looking at testimony that was submitted 
earlier, and the testimony that we received today. The 
difference in your testimony was that on page nine of the old 
testimony, ``CDC is not a law enforcement agency and such 
responsibilities are considered beyond CDC's expertise.'' It 
goes on down. The ending says, ``Nevertheless, CDC cannot 
function effectively. Our developing a primary law enforcement 
regulatory role is beyond, and in many respects, contrary to 
its mission, staffing and expertise.''
    Why was this taken out in the last couple of days?
    Mr. Raub. May I comment?
    Mr. Green. Mr. Raub?
    Mr. Raub. My understanding is that, when the draft 
statements were reviewed centrally within the administration by 
the Office of Management and Budget, there was a concern that 
statement might be interpreted that the crime bill--to which 
both Mr. Reynolds and I have alluded--was, in fact, completed. 
To the best of my understanding, it is not. I think the intent 
was, simply, not to suggest or imply that work was complete 
and, therefore, had certain provisions, including ones that 
might materially change the role of the CDC.
    Mr. Green. Okay. I look forward to seeing the bill. I would 
hope that the bill would not make the CDC the enforcement 
mechanism. Again, I think it is much past your role and scope. 
Maybe that is one of the suggestions that the bill may do. 
Again, since we haven't seen, and I know you are drafting it, 
that is not necessarily what this is. It doesn't relate to the 
bill. It talks about the concern the CDC has from the earlier 
responsibilities. CDC doesn't have any considerable law 
enforcement skills, I assume. I have never thought of CDC as a 
law enforcement-type agency.
    Mr. Ostroff. Yes, nor have I.
    Mr. Green. And I imagine no one else there. Hopefully, the 
bill will not make you a law enforcement agency. Obviously, I 
have confidence in the folks at the other end of the table that 
can help you.
    Dr. Ostroff, do you still have concerns about the law 
enforcement duties that you may have under current provisions?
    Mr. Ostroff. Well, I think what we can say is that there 
can be an inherent conflict between our primary public health 
mission, which is a very collaborative working relationship 
with a variety of partners--whether they are State and local 
health departments; whether they are academic facilities; 
whether they are private entities--and the need to regulate 
under this particular provision. So there is the potential 
inherent conflict.
    Mr. Green. And I can understand. I think all of us do. To 
follow-up my colleagues, for example, if a local lab has a 
biohazard label, and FedEx, UPS or the Postal Service picks it 
up, do they assume liability for that? I don't know about the 
Postal Service, but FedEx and UPS. If one of their vehicles has 
an accident, who has the liability for that at that time?
    Mr. Ostroff. I can't answer that particular question. We 
could certainly look into it.
    Mr. Green. Again, I think all of us are concerned, like 
each of you at the table are, on the effectiveness of both 
current law and also, hopefully, the bill that is going to be 
sent up as soon as possible, because of the concern that not 
only we have. Again, I appreciate the chance for you testify 
today and raise a lot more questions. Thank you, Mr. Chairman.
    Mr. Upton. Mr. Burr.
    Mr. Burr. Thank you, Mr. Chairman. Let me ask you, is the 
CDC comfortable with the role that they are being slotted into?
    Mr. Ostroff. Well that is, obviously, not an easy question 
to answer. I think that what I can say is that we have 
attempted, to the best of our abilities, to implement the 
regulations and carry them forth. I think it has been obvious 
in some of the statements that it has not been easy for us to 
do this, because it is a relatively non-traditional role for us 
to take.
    Mr. Burr. Do you have sufficient resources to do it?
    Mr. Ostroff. We are in the process of expanding, for 
instance, the number of inspectors that we have, so that we can 
increase the pace of inspection. As I mentioned, we do have a 
commitment to inspect all registered facilities at least once 
during the 3-year time period. We got a fairly slow start in 
doing that.
    Mr. Burr. What specific budget requests have you made to be 
able to carry that out, if any?
    Mr. Ostroff. There was a budget request in this fiscal year 
for $1 million to carry out this program.
    Mr. Burr. So $1 million will assure us that all of the 
functions of CDC, relative to this issue, will be carried out.
    Mr. Ostroff. With the regulation, as it is currently 
written. That is correct.
    Mr. Burr. Do you think that is a sufficient resource, from 
a monetary standpoint?
    Mr. Ostroff. Again, we have been able to expand our 
activities, now that there are resources, to conduct this 
program. I will say that if our responsibilities are expanded, 
we will need additional resources.
    Mr. Burr. Mr. Burnham, does a million dollars give you a 
comfort level that you can reassure this committee that they 
can carry out their role? You, as law enforcement, does a 
million dollars give you a comfort level?
    Mr. Burnham. Again, that is kind of out of my purview. I do 
have an interest in control, because from a law enforcement 
standpoint we are interested in who ultimately ends up with it. 
As I said in my testimony, under law, absent an indication it 
is to be used as a weapon--or intent to use it as a weapon--
there is no violation. I don't think I can comment other than 
that.
    Mr. Burr. Does the FBI believe that the current CDC 
regulations governing the transfer of biological weapons are 
adequate to prevent would-be terrorists or criminals from 
acquiring such materials?
    Mr. Burnham. Again, I am not an expert on CDC controls. 
While we do have controls, we don't have the select agents.
    Mr. Burr. But you are the law enforcement arm that will 
look at this coordinated effort. I guess what I am asking is 
that CDC is part of this effort to give us the assurance--or to 
give the FBI the assurance--that would-be terrorists won't have 
access.
    Mr. Burnham. Well, we would work with CDC. We have been 
working with CDC and HHS. We will continue to.
    Mr. Burr. Is the FBI currently involved in the process of 
approving the registration of facilities and transfers of 
biological agents?
    Mr. Burnham. No.
    Mr. Ostroff. No.
    Mr. Burr. Does the CDC and law enforcement communicate? Do 
you sign off on the license approvals?
    Mr. Burnham. No.
    Mr. Burr. Would you like to?
    Mr. Burnham. Again, that is kind out of the purview of what 
I am here testifying about. Again, we are talking with CDC, HHS 
and the Department of Justice on this.
    Mr. Burr. Let me ask it this way: does the CDC contact the 
FBI and say, ``We have an application for a license, could you 
do a background check on this individual?'' Do we do that?
    Mr. Burnham. No.
    Mr. Burr. Does the FBI believe the current CDC regulations 
are guidelines regarding facility security; that it is adequate 
to ensure the safety and security of select biological agents 
that are there? In other words, have you done a security review 
of all these facilities out there, and come to the conclusion 
that their security there is good enough to assure us that 
those agents stay there?
    Mr. Burnham. No, we haven't.
    Mr. Burr. Have we ever had, Mr. Reynolds, any biologics 
that might be missing in the system?
    Mr. Reynolds. We have had some potential indication of 
items that may be missing. But there has never been a question 
as to whether we have an inventory control problem, or 
materials that actually walked out of the facility.
    Mr. Burr. Is there any requirement that the laboratories, 
or facilities, report on inventory shortages?
    Mr. Reynolds. The requirements that exist right now are the 
ones that are contained in the CDC regulations. That, to my 
knowledge, is all that exists.
    Mr. Burr. I would ask unanimous consent to continue on and 
go in reverse order.
    Mr. Upton. Dr. Ganske.
    Mr. Burr. Oh, I am sorry. I didn't see Dr. Ganske come in. 
I would ask unanimous consent for 1 additional minute just to 
finish this question.
    Mr. Upton. Go ahead.
    Mr. Burr. Is there a requirement in this proposal that CDC 
notify the FBI, if they discover some shortage, loss, or 
possible theft of such an agent?
    Mr. Reynolds. Well let me say this, I don't think that we 
view that any Government agency would have to have a statutory 
requirement to do that. Our anticipation, right now, is that 
CDC would do that. We have been contacted, on occasion, by CDC 
expressing concern in something that they have observed.
    Mr. Burr. I look forward to the second round. Thank you.
    Mr. Upton. Mr. Ganske.
    Mr. Ganske. Thank you, Mr. Chairman. Mr. Burnham, in your 
testimony you mentioned ricin several times. This is a question 
for you, or anyone else on the panel. Can you tell me what it 
is, chemically? How is it produced? What does it do 
physiologically?
    Mr. Burnham. Well it is a biological agent. It is a 
produced from the castor bean. As to the actual effects, I know 
what the ultimate effect is: death. As to the sickness you may 
go through, or the symptoms, I am not sure.
    Mr. Ganske. Maybe, Dr. Ostroff, can you expand on that?
    Mr. Ostroff. I am not quite as familiar with the toxins as 
I am with the biological agents, because I work in the National 
Center for Infectious Diseases. Ricin very rapidly induces 
paralysis and death.
    Mr. Ganske. Has it been proven that it can be absorbed 
using DMSO?
    Mr. Burnham. No.
    Mr. Ganske. Okay. Dr. Ostroff, in your testimony on page 
two you say, ``This regulation is designed to ensure that these 
infectious agents are shipped only to institutions or 
individuals equipped to handle them appropriately; and only to 
those who have legitimate reasons to use without posing undue 
burden on the legitimate user community.''
    Can you take us on a step-by-step description of what 
happens when a lab gets a request to send out some of these 
infectious agents?
    Mr. Ostroff. Well, as far as a request, or are you talking 
about the application process to become registered in order to 
be able to ship?
    Mr. Ganske. Well, we may hit the latter, in a minute. Let 
us say that a lab that has an infectious agent gets a request 
to send it out somewhere, to somebody. What happens?
    Mr. Ostroff. Right. Again it depends if they are already 
registered under the select agent rule, or if they are new. 
What they would have to do is they would have to determine 
whether or not the requestor also is registered under the 
select agent rule, because our requirements are that they can 
only ship one of these select agents to someone who is also 
registered.
    The request has to be submitted----
    Mr. Ganske. How do you know that they do that?
    Mr. Ostroff. Excuse me?
    Mr. Ganske. How do you know?
    Mr. Ostroff. What they have to do is they have to notify 
us.
    Mr. Ganske. So, when they get a request to send an agent 
out, then they are supposed to let you know?
    Mr. Ostroff. Only if they intend to actually honor that 
request. If they choose not to honor that request, then there 
is no need for them to notify us--unless they have some 
particular question about the validity of the request. But that 
is not a requirement.
    Mr. Ganske. They have a form they fill out and send to you? 
They give you a phone call?
    Mr. Ostroff. They send us a form.
    Mr. Ganske. Okay. Can they send it out before they hear 
back from you?
    Mr. Ostroff. No.
    Mr. Ganske. What do you do when you get that request?
    Mr. Ostroff. We verify the accuracy of the information that 
is on the form. Again, the requestor cannot be the only 
individual requestor. Each facility has to have what is known 
as a ``responsible facility official,'' who has to double co-
sign the form itself. The responsible facility official cannot 
be somebody directly related to that particular work. Usually 
it is the biosafety officer for the institution. So there are a 
number of redundant steps that would assure that the potential 
recipient has a legitimate reason to make that request.
    Mr. Ganske. So only authorized recipients can get the 
material?
    Mr. Ostroff. Yes.
    Mr. Ganske. So both the sender and the receiver have to get 
an authorization?
    Mr. Ostroff. Correct. They have to be registered.
    Mr. Ganske. But the problem is that a bunch are not 
registered.
    Mr. Ostroff. Well, again, it has always been difficult for 
us to determine the total universe of facilities that 
ultimately would be registered because they wish to ship or 
receive one of these agents. What I can say is we are unaware 
of any shipments that have occurred to, or from, non-registered 
facilities.
    Mr. Markey. Mr. Chairman?
    Mr. Upton. The gentleman from Massachusetts.
    Mr. Markey. Mr. Chairman, I am not a member of the 
subcommittee.
    Mr. Upton. Some of us breathe in relief of that.
    Mr. Markey. I request, at your sufferance, that I be 
allowed for a brief period of time.
    Mr. Upton. Knowing of your interest--particularly you 
authorship of a number of regulations in laws written with 
regard to shipping--I certainly don't have any objection. We 
will yield you 5 minutes.
    Mr. Markey. Thank you, Mr. Chairman, very much. I 
appreciate your indulgence. I authored, with John Kasich and 
Joe Kennedy on the House side, and Senator Hatch on the Senate 
side, the Infectious Agents Control Act of 1996.
    Mr. Upton. Excuse me. I will restart you time. A vote has 
started. Mr. Burr has gone over to vote and he will come back. 
We will continue with this panel. If members that would like to 
go vote and come back to do a second round, that will be 
terrific. We will start your time over, Mr. Markey.
    Mr. Markey. That became part of the Antiterrorism and 
Effective Death Penalty Control Act of 1996.
    I wrote to CDC, early last year, to get a status on the 
implementation of the regulations that have been put on the 
books. At a briefing, I received in response to that letter--
and was shocked to find out that--as of April 1998, that only 
62 facilities had registered, and only 142 transfer shipments 
had been recorded. So based on the testimony, it is clear that 
some improvement has been made--not much--but some. It is now 
123 facilities, and over 600 transfers.
    Dr. Ostroff, why has it been so difficult to get greater 
compliance?
    Mr. Ostroff. Well, again, Congressman, we don't have any 
information suggesting that there has not been compliance. The 
likelihood is that in some instances, for a variety of reasons, 
some facilities have chosen not to go the route of 
registration.
    Mr. Markey. How many facilities do you believe are out 
there?
    Mr. Ostroff. Well, again, that has been a very difficult 
number to come up with. The estimates have always been that as 
far shipment and receipt are concerned, the number is probably 
somewhere in the range of 250-300.
    Mr. Markey. You have now registered 123?
    Mr. Ostroff. Correct. Again, there are about five new 
facilities, per month, that are now coming on to register.
    Mr. Markey. What grade would you give the industry in terms 
of their cooperation on this matter? It has been years, now. 
You know where they are. You know how many facilities there 
are.
    Mr. Ostroff. I think that there has been a great deal of 
cooperation.
    Mr. Markey. So you would give them an ``A'' for their 
cooperation?
    Mr. Ostroff. ``A-minus.''
    Mr. Markey. An ``A-minus,'' interesting. I wouldn't give 
them an ``A-minus,'' at all, sir.
    Following-up on Mr. Green's question regarding CDC 
continuing to do law enforcement work, who, in your opinion, is 
better able to do that work, Dr. Ostroff?
    Mr. Ostroff. I think that, as far as who is in the best 
position to administer any expansion of a program like this, I 
think that a variety of different models would have to be 
explored. Clearly, there needs to be some collaborative effort 
between the public health scientific community and the law 
enforcement community.
    Mr. Markey. How many inspections have been done?
    Mr. Ostroff. To date, 15.
    Mr. Markey. Only 15.
    Mr. Markey. Have any of the facilities had serious 
problems?
    Mr. Ostroff. One.
    Mr. Markey. Could you tell us what that problem is?
    Mr. Ostroff. Let me turn to Dr. Richmond to specifically 
address that, since he is more knowledgeable about what was 
found.
    Mr. Richmond. That particular facility had indicated that 
they were capable of working at what we would call a Class A, 
Level 3. On inspection, we found they were not in full 
compliance with that. We suspended their activities for 
shipping and receiving.
    But in the process, we are also working very cooperatively 
with the institution to try to remedy and rectify that. It is 
our intention to assist them in becoming fully compliant.
    Mr. Markey. What was the public risk that this facility 
posed?
    Mr. Richmond. It was not necessarily a public risk, so much 
as it was a risk to the investigators. That is what the 
biosafety manual clearly focuses on.
    Mr. Markey. Could you explain that, the risk to the 
investigators?
    Mr. Richmond. It was a question of not having appropriate 
containment; not having appropriate facilities in which to do 
the work. Airflow systems were out of balance; access by people 
walking through the corridors--it was not a controlled 
environment.
    Mr. Markey. So----
    Mr. Upton. Mr. Markey?
    Mr. Markey. Yes, sir.
    Mr. Upton. I wonder if----
    Mr. Markey. I would be glad to yield to the gentleman.
    Mr. Upton. What were the agents?
    Mr. Richmond. It was bacterial agents that were being 
prepared in quantity to be shipped to a research facility.
    Mr. Upton. Specifically, what were the agents?
    Mr. Richmond. I don't recall, sir.
    Mr. Upton. Could you provide that to the committee, please?
    Mr. Richmond. Absolutely.
    [The following was received for the record:]

    The agent involved was a fungal agent called Coccidioides 
immitis.

    Mr. Markey. So in conclusion, Dr. Ostroff, you don't 
believe, then, that we have a China problem here? We don't have 
the kind of issues that now surround our nuclear weapons 
laboratories? You think the industry has cooperated 
sufficiently; we can give them an ``A-minus,'' and they just 
need a little bit of improvement?
    Mr. Ostroff. Again, we have no evidence that anyone has 
thought to circumvent this particular regulation by illegally 
shipping.
    Mr. Markey. Thank you, Mr. Chairman.
    Mr. Upton. We will move into round two. I have a basic 
question that I want to make sure that I understand. It is 
going into the some of the questions that Mr. Markey, and some 
of the others, asked.
    It is my understanding that there is no current requirement 
that labs should notify the FBI in case of loss, or theft, for 
unregistered companies, right? If you are registered with CDC 
and the shipment does not show up for whatever reason, there is 
a requirement that they alert the CDC. That is the case.
    Mr. Ostroff. Yes.
    Mr. Upton. But if it is unregistered, then there is really 
no checks at all, is that correct?
    Mr. Ostroff. Well, if it is an unregistered facility, they 
should not be shipping or receiving. That wouldn't be legal.
    Mr. Upton. If you are unregistered, you are not supposed to 
be doing it, but there is no check. There is no verification. 
There is no way of finding out whether or not that is actually 
happening. Isn't that right?
    Mr. Ostroff. That is correct.
    Mr. Upton. The way that you are registered really dates 
back to the old regs that were put into effect that if you had 
it since 1997. So all those folks who had it prior to 1997, 
there is no requirement for them to register at all.
    Mr. Ostroff. Unless they intend to ship or receive.
    Mr. Upton. The administration proposal that is soon to be 
sent up to the Hill, does it include any jurisdiction on re-
registering those folks that are not required to register 
today, in other words, those that had it prior to 1997?
    Mr. Ostroff. The proposal will include aspects that extend 
the coverage to include those who possess, but don't intend to 
ship or receive.
    Mr. Upton. So the whole universe will be included?
    Mr. Ostroff. Correct.
    Mr. Upton. Everybody supports that? Does CDC, HHS, everyone 
support that?
    Mr. Ostroff. Yes.
    Mr. Upton. Mr. Reynolds?
    Mr. Reynolds. Well, I don't want to prejudge the bill that 
actually ends up here. It is a difficult task to come up and 
testify about a prospective bill when you don't have the bill 
and we don't have the final version. That has not been an area, 
in recent time, that has been controversial.
    I think there is agreement on the need to close the gap 
from where we are right now where we cover transportation, or 
shipment in and shipment out of the organization; but we don't 
cover the manner in which they possess it. We don't require a 
reporting of possession. What we would like in this 
legislation, through an unsafe handling provision, is a 
statutory provision that would give us a basis to address that 
laboratory that grossly deviates from the accepted standards, 
and therefore, runs a risk through lack of security that 
materials that are highly dangerous would leave their 
laboratory.
    Mr. Upton. Okay. We are going to take a brief recess. Well, 
the brief is now over.
    I pass the baton to Mr. Burr. I know other members are on 
their way back. Thank you.
    Mr. Burr. [presiding] I didn't hear anybody clap when he 
said that.
    Let me go back to CDC for a second. I would like you to 
walk me through. How quickly would the CDC know whether there 
was a missing shipment?
    Mr. Ostroff. Again, the receiving facility is supposed to 
notify us within 72 hours that the material has been received.
    Mr. Burr. How are they notified that shipment took place?
    Mr. Ostroff. Excuse me?
    Mr. Burr. How are they notified that the shipment took 
place?
    Mr. Ostroff. The shipping facility must notify both CDC, as 
well as the recipient, of the intent to ship.
    Mr. Burr. And the recipient, if they don't receive it in 72 
hours, is bound to contact CDC?
    Mr. Ostroff. Correct.
    Mr. Burr. What happens if they don't contact you? In other 
words, let me ask one question in between. Are they required to 
contact you to tell you that they did get the shipment?
    Mr. Ostroff. Yes.
    Mr. Burr. Or just didn't get the shipment?
    Mr. Ostroff. No, did. Again, since we receive notification 
from the shipper that a shipment is en route; if we then did 
not receive something from the recipient indicating that it had 
been received, we would follow-up on that.
    Mr. Burr. Now, if they didn't contact you, what would 
happen?
    Mr. Ostroff. We would contact them.
    Mr. Burr. If they didn't get the shipment, what would 
happen?
    Mr. Ostroff. Several things would happen. There would be an 
attempt to try to track it. We would also notify the 
appropriate law enforcement authorities.
    Mr. Burr. That would be?
    Mr. Ostroff. Most likely, the FBI.
    Mr. Burr. Is there a specific division within the FBI that 
everybody in that particular area of CDC know who the contact 
is, and this is the telephone number?
    Mr. Ostroff. I believe so.
    Mr. Burr. That is a written policy with the CDC?
    Mr. Ostroff. Correct.
    Mr. Burr. Is there a policy at the FBI if you get a call 
from the CDC relative to a shipment that is missing?
    Mr. Burnham. Absolutely. In fact it would come into our 
weapons of mass destruction unit. If we received notification 
of a shipment like that, we would contact the appropriate field 
office, do a threat assessment, and respond accordingly.
    Mr. Burr. Has it ever happened?
    Mr. Burnham. No.
    Mr. Burr. Has a shipment ever not made it?
    Mr. Ostroff. No. There was one episode, that I am aware of, 
where the paperwork got lost, but the shipment had actually 
been received. That was promptly dealt with. It was just a 
matter of the paperwork not following the material.
    Mr. Burr. What is the FBI's general sense of the security 
of the laboratories and facilities that were shipping 
biologics? Have they ever made any assessment?
    Mr. Burnham. No. I think that I stated that earlier. We 
haven't made any site assessments. We haven't done any 
vulnerability assessments with threat analysis. So, to answer 
your question--no.
    Mr. Burr. What is your sense of the coverage of the select 
agent list? Have you assessed that list?
    Mr. Burnham. No.
    Mr. Burr. So we don't really know today whether we are 
capturing everything we should be targeting?
    Mr. Burnham. Again, I am not a scientist and I am not 
expert in this; but I do know that it is constantly changing--
you know, genetic engineering and stuff like that.
    Mr. Burr. Whose responsibility is it?
    Mr. Burnham. I would suppose it would be CDC's.
    Mr. Burr. There is nobody in law enforcement that goes 
through an evaluation of those agents that might risks? If they 
find one, are they double-checking to make sure CDC has it on 
an agents list?
    We are not here to try to pick apart. We are here to try to 
raise our comfort level, or possibly raise some questions on 
some things we haven't thought of--some areas that haven't been 
addressed. There is a requirement here. I think Mr. Stupak got 
to it.
    One, is CDC the appropriate place? I don't think we are 
here to judge that. We are here to ask questions so that there 
is an assurance that the choice is correct. If so, do you have 
the resources? If you have the resources, do we have the 
structure of how everything works where everybody understands 
it? Does Mr. Reynolds and the Department of Justice understand 
it? Does the FBI understand it? Does HHS understand it? So that 
on your side of it, everything runs smooth; Mr. Reynolds' side, 
everything runs smooth.
    I have to be totally honest with you. I don't think that 
you have all the answers. I am not sure, yet, that you have all 
the questions. I think that, hopefully, if you garnish anything 
out of this hearing it will stimulate the need for some more 
questions to be asked.
    What does the law enforcement community think about the 
current exemptions to CDC regulations?
    Mr. Reynolds. This would relate to, for instance, shipment 
overseas----
    Mr. Burr. Clinical labs.
    Mr. Reynolds. Again, we are going to defer to CDC on that. 
We don't have an independent basis for assessment at this 
point. We remain concerned that we have a sufficiently secure 
system. To back this issue back one step, we are concerned 
right now of even having the statutory jurisdiction to deal, in 
the way of a prosecution, if in fact CDC came to us with a 
violation.
    Right now you have misdemeanor enforcement of their 
transfer regulation. For example, if you had a theft from the 
shipment, there is a real question to be addressed.
    Mr. Burr. Clearly, your belief is that the administration 
in their crime bill will try to tie these loose ends up, so 
that the enforcement side and the prosecution side exist.
    Mr. Reynolds. That is exactly right. That is what this is 
about. It is an attempt to tie these loose ends up.
    Mr. Burr. I hope you understand my concern that if, today, 
law enforcement does not have a position on the question of 
exemptions--clinical labs and other things--that is in the 
statute, then I have to wonder how closely we looked at the 
whole process. I get the impression that you have looked at 
your piece; and you have looked at your piece. Somewhere, there 
is hopefully somebody that is coordinating this whole thing to 
ultimately make all the pieces fit.
    Mr. Reynolds. This was looked at, at one point. But the 
time at which law enforcement participated in the examination 
was the time of the development of what became the HHS 
regulations. Those regulations were designed as part of an 
interagency group. The Department of Justice and FBI 
participated, as did a number of other agencies. It would be 
fair to say there was give and take as far as the 
comprehensiveness of those regulations. But at that time, we 
were satisfied that those regulations represented a very 
productive step forward.
    I think they did, at that time. There is a valid question, 
now, in light of the experience in the last 3 years, whether 
they should be tightened. We believe they certainly should be 
tightened, or there should be a new statutory structure to 
cover possession. I think you were out of the room at the time, 
but we talked in terms of these regulations covering transfer 
to a facility. If the facility wants to transfer the select 
agent out later, then the regs pick it back up. The regs don't 
deal with it while it is at the facility, which is a concern to 
us and would be addressed under this legislation.
    Mr. Burr. Let me bring one fact to light and ask you if it, 
in any way, raises your sense of urgency on clinical labs. 
There are 150,000 clinical labs. Am I correct? So particularly 
for that one slice there are 150,000 possible exemptions. Is 
that a comfort for law enforcement? I will leave that as an 
open-ended.
    Mr. Reynolds. Let me just say that in that regard, 
obviously, as law enforcement people and prosecutors, our 
educational background and experience is in investigating, law, 
and in prosecution. So we are dependent upon seeking expert 
scientific advice, as we do. We look to HHS; we look to CDC to 
provide that advice. We don't have a good independent basis.
    Mr. Burr. Would you disagree that the policy should be a 
balance between deterrent and the ability to enforce law?
    Mr. Reynolds. That is absolutely correct.
    Mr. Burr. You are right. Based upon the structure, CDC has 
the ability to say, ``Even with 150,000 clinical labs, we still 
think they should be exempt.'' I hope that the law enforcement 
side is saying, ``Tell us why. Make the case to us; because we 
see 150,000 uncontrolled clinics as a potential high-risk 
area.'' Hopefully, if that exchange hasn't taken place, you 
will ask that question. This side will provide that answer. If 
it is not sufficient for law enforcement, we might go back to 
the table and look at that a little bit further.
    Let me just ask a couple more questions, because Mr. Stupak 
is back. Mr. Reynolds, in your testimony you stated that under 
current law, by the time the biologic weapons or devices had 
been created, or were under development, it may be too late to 
undertake action to prevent the attack. I think that is a 
pretty important point. I wanted to ask you to describe a 
little more about it. Is there a particular case that you could 
provide any more detail on, for the committee?
    Mr. Reynolds. Well, some of the cases were discussed in Mr. 
Burnham's testimony. Let me focus on the specific aspects and 
start with the most difficult. That is, where the weaponization 
is simply the use of the biological agent to place on the salad 
bar, as occurred in Antelope, Oregon, in 1985. About a couple 
hundred people became seriously ill.
    Another situation occurred, more recently in Dallas, Texas, 
where the biological agent was placed on doughnuts. I think 18 
or 19 people became ill. The weaponization, in that situation, 
is not concoction of a device, per se; but simply the taking of 
the biological agent and physically placing it on the food 
supply.
    Mr. Burr. Let me see if I understand you. If, in fact, a 
shipment is diverted or stolen, at some point soon after then, 
our concern or risk never gets higher. Once they have the 
biological agent, they don't necessarily have to have the 
attack planned, or the device made; but our risk is every bit 
as great.
    Mr. Reynolds. There is a risk that is there from the start. 
Let me distinguish between two things for you. The regulations 
that exist right now relate to select agents, of which there 
are approximately 40 on the list. There are many other 
biological substances, obviously. The ones that were used in 
Antelope, Oregon, and Dallas, Texas, which made people sick 
were salmonella and shigella, neither of which is on the select 
agent list. There is the potential for vast damage to be done 
with agents that are not a part of that select agent list, or 
the CDC regulatory process--absent the placing of them on the 
select agent list.
    Mr. Burr. Let me ask you one last question. You can elect 
not to answer it if you want to. Even under the 
administration's new crime bill proposal, would you say that 
our regulations on guns in this country is stricter than the 
proposal that we have made on biological agents?
    Mr. Reynolds. That is a difficult question to answer. The 
biological weapons legislation that has been developed, is 
developed to focus on biological agents, and the specific 
aspects of biological agents. It is, in many ways, very 
different. There is some analogies that can be drawn, but it is 
really very different.
    It includes an unsafe handling provision. I suppose you 
could analogize in firearms law to what is being discussed 
right now in the way of safety locks. But the unsafe handling 
provision on the biological side, obviously, is more extensive 
than the safety lock proposal.
    There are some aspects as relates to restricted persons 
that might be analogous, depending on the final shape of this 
bill. Unjustified possession is extraordinarily important to 
us. If the FedEx employee steals the material out of the 
interstate shipment, what is our Federal violation to deal with 
that right now. We are in a very difficult position. Theft from 
interstate shipment requires a certain threshold of monetary 
value before we have jurisdiction.
    Mr. Burr. If a felon has a handgun, there is a law, isn't 
there?
    Mr. Reynolds. If a felon has a handgun, there is a law. 
That is correct.
    Mr. Burr. I only raised the question, not to have you 
comment on our gun laws; but to point out the fact that we 
spend a tremendous amount of time trying to find the right 
balance there and debating what the right balance is. We 
address it very quickly when we have a situation that arises. I 
am sure that we will have further debates based upon this 
morning's current conflict. Biologic agents are every bit the 
threat--if not more--and much tougher for us to maybe set a 
structure that we feel confident works. I am not sure that we 
spend quite the same amount of time trying to get it right. At 
least to this point, we have not, as we do in gun enforcement.
    The Chair would yield to the gentleman from Michigan, for 
10 minutes, if he needs it.
    Mr. Stupak. Thank you. Dr. Raub, how many people die each 
year from infectious diseases?
    Mr. Raub. I don't know off-hand, sir.
    Mr. Stupak. Does 17 million, sound right, worldwide?
    Mr. Raub. Worldwide, that is possible, yes.
    Mr. Stupak. How many die from bioterrorism attacks?
    Mr. Raub. I am not aware of any, sir.
    Mr. Stupak. Okay. So when we start talking about biological 
weapons, people get scared. They get very scared, even though 
these biological agents have been amongst us, in the world, for 
centuries. Once we start saying that these agents can, 
theoretically--and I want to emphasize theoretically--be 
weaponized, aren't we demanding an extremely high level of 
security, then, in all aspects of handling these materials?
    Mr. Raub. In the antibioterrorism initiative we have 
proposed, we have tried to distinguish between the organisms 
that are potentially weapons of mass destruction--that is, that 
could be used on an area as broad as a municipality--as 
distinct from some that could be used in a harmful way, but in 
much more limited circumstances. So we have tried to make that 
measure and distinction.
    Mr. Stupak. Give me an example of what you are talking 
about.
    Mr. Raub. Well, for example, high on our list as an agent 
of concern for bioterrorism is anthrax.
    Mr. Stupak. Anthrax, okay.
    Mr. Raub. It is based on the characteristics of the 
organism. It has a spore form as part of its natural life-
cycle, which lends it to being weaponized. Moreover, in 
previous decades, a number of nations worked with weaponizing 
this material. So there is some basis of experience out there.
    The spores, relatively speaking, are easily aerosolized. It 
can be released into the air, and create a broader threat than 
would be true than with, say, salmonella or other agents that 
might be in food.
    Mr. Stupak. Salmonella is not one of these 40 agents.
    Mr. Raub. That is correct. It is not.
    Mr. Stupak. So it wouldn't be fair to put salmonella in 
that.
    Mr. Raub. No, I was making the contrast that you asked for, 
sir.
    Mr. Stupak. So when we are dealing with anthrax or these 40 
special agents, are you then asking us to put in extremely high 
levels of security in all aspects of handling things like 
anthrax?
    Mr. Raub. No, sir, we aren't. I believe that, when the 
crime bill proposal comes forward, it will capture a balance 
between promoting additional attention to security and safety; 
but still within the kinds of guidelines that we have. While 
putting some additional requirement on the research, laboratory 
and public health communities, it will be balanced by related 
provisions, such as those Mr. Reynolds was describing, having 
to do with additional criminal authorities with respect to 
inappropriate possession, reckless handling, and so on. It is 
the balance of those that will be important in the bill.
    Mr. Stupak. Reckless handling and all that. That is a crime 
and no problem with that stuff. That should be in a crime bill. 
Again, our jurisdiction here is the labs. I guess what I am 
trying to get at is that if you have these 40 agents that we 
have theorized that mass destruction and everything else is 
going to happen, can someone explain to me what are your 
procedures? What are your regulations you are proposing for 
these labs?
    We have 11 CDC labs. We have 1,500, I think Mr. Burr said, 
other labs. How are you going to safeguard? What are your 
policies? What are your regulations? What are your inspections? 
What are we talking about here? What do you want us to 
implement? Can anyone answer that--Dr. Raub or Mr. Reynolds?
    Mr. Raub. From the laboratory side, I can say only that 
until the decisions are made about what the specific content of 
the legislative proposal will be, we won't be able to----
    Mr. Stupak. Well, you just said that I would probably see a 
nice balance here.
    Mr. Raub. That is certainly the intention, sir.
    Mr. Stupak. Well, tell me this nice balance that may be 
coming.
    Mr. Raub. I think, as in my statement and in Mr. Reynolds', 
we have identified the areas that need to be addressed. What I 
was emphasizing there is that if all those areas are addressed 
simultaneously and in relation to each other, it will 
constitute a balance that will not put an undue on weight on 
any part of this.
    The stated concern on the part of the Attorney General is 
not to chill important research and laboratory work. That is 
certainly a concern of ours. I am hopeful of that.
    Mr. Burr. Will the gentleman from Michigan yield for one 
question?
    Mr. Stupak. Yes, sure.
    Mr. Burr. Let me ask any of you: how many labs that handle 
nuclear material go unregistered?
    Mr. Reynolds. They are regulated by the NRC, as you 
probably well know.
    Mr. Burr. All of them?
    Mr. Reynolds. If they handle nuclear material. As far as I 
am aware, it is a highly regulated system.
    Mr. Burr. Is there a significant difference between the 
threat in nuclear material and biological agents?
    Mr. Reynolds. It depends on the threat that one is talking 
about. If you are talking about a threat in the immediate area, 
it may be that the nuclear threat is greater to those 
immediately surrounding the area. If you are talking about the 
potential for use by a terrorist, it may be that the biological 
substance is the most pervasive challenge that we face in the 
terrorism area.
    Mr. Burr. I thank you. I thank the gentleman for yielding.
    Mr. Stupak. Going back to our questions there. You mention 
the Attorney General; you mention your testimony, and if we 
would implement these things that are in here. But what I see 
in all the testimony, and what I have heard, thus far, is 
talking about the 21st century crime bill, which will 
strengthen our efforts to combat international crime and 
terrorism. The threat of weapons of mass destruction is real 
and increasing in the age of technological change and open 
borders. The bill will make it a Federal crime to possess these 
agents. I agree with all that, okay?
    Possession of biological agents not justified, I agree with 
you. Unsafe handling, I agree with you. Unregistered 
possession, I agree. Knowingly perpetrating a hoax regarding 
biological agents, I agree. Possession of select agents by 
restricted individuals--agree. Those are crimes. They could 
file them in title 18 of U.S. Code, probably.
    But let us get back to these labs, these 11 labs. You can 
pass these crimes; but once they get out there, what are you 
asking these labs to do? I am afraid that what is going on here 
is that we are looking at the crime aspect. But where they are 
developed; where they are moved; where they are transferred, 
and where there is access or they are readily accessible, there 
is not the physical nor the internal security that would be 
needed to prevent the unauthorized use or things that you see 
which could promote weapons of mass destruction.
    So what do you see in these registrations and inspections 
of these labs? How do you handle it when you pass your crime 
bill?
    Mr. Raub. The answer is, not having the specifics of the 
bill, I am not able to address that.
    Mr. Stupak. It is not necessarily the specifics of the 
bill. Aren't you concerned--the cost? We have $1 million, based 
on one regulation, and that was just right at the labs. There 
is also a deep concern that the independent scientific 
credibility of the CDC will be seriously weakened by the 
recognition that, if you put it on CDC are they now going to be 
responsible for policing the external organizations, 
institutions, and individuals that they are trying to develop 
working with relationships with to wipe out diseases and other 
problems that develop up, worldwide? I don't think CDC wants to 
be targeted agency, or law enforcement activity. Have you guys 
given any thought to that?
    Mr. Raub. Sir, again, I don't believe anybody involved 
wants to compromise the CDC's pursuit of its mission, as the 
price of making the needed improvements here.
    Mr. Stupak. Okay.
    Mr. Raub. On the other hand, I think we all recognize that 
the Department of Health and Human Services must be part of the 
solution to this. We need to be effective partners with the 
Department of Justice and with other parts of the 
administration. We will do our best at that.
    Mr. Stupak. Do you want HHS to do the inspections, then, of 
labs?
    Mr. Raub. That is still under discussion, sir.
    Mr. Stupak. Can you give me any drift of where you guys are 
going? Are still drifting out there? I have heard of all these 
discussions. There has been testimony about the administration 
having discussions and trying to formulate. Well, tell us what 
you are trying to formulate. Maybe we can help. We don't want 
to be adversarial here. This is a serious matter. We would like 
to help out.
    We have made comparisons, now, to gun laws; to nuclear 
weapons; to weapons of mass destruction by bioagents, even to 
salmonella. We are all over the map here. Focus us in. What are 
you trying to accomplish here? How are you going to do it? Give 
us some idea so we can help.
    Mr. Reynolds. Can I address that from a law enforcement 
perspective? Do we have the time?
    A key factor in the legislation that we anticipate will be 
sent to the Hill is to give law enforcement the opportunity to 
move into the investigation at an earlier period of time. The 
statutes that we have right now were a good first step when 
enacted, but they require that we develop some evidence of 
intent, or weaponization, which puts us well down the line in 
preventing the terrorist act. The statutes that we would 
anticipate, or the legislation we would anticipate sending up, 
on justifiable possession, reckless handling, and possession, 
all give us a basis to move into an investigation at an earlier 
time in an effort to avoid the catastrophe that could occur.
    Mr. Stupak. I don't disagree with any of that. Having been 
a cop for 12 years, I agree totally. But then, we should leave 
the labs alone. Give it to the FBI and Justice. Let them do 
their job; and not put all kinds of regulations on labs that we 
can't even have a knowledge of what we are going to do, or how 
we are going to enforce it. Let CDC do their job. Give the FBI 
or Justice whatever they need to do their job.
    If we have to tighten up some criminal laws, I am all for 
it. I will be happy to help you. It would be outside the scope 
of this committee. With that, Mr. Chairman, I yield back to 
you.
    Mr. Upton. [presiding] Thank you, Mr. Stupak. Mr. Burr, do 
you have further questions?
    Panel, we thank you very much for your testimony this 
morning. We look forward to seeing the recommendations from the 
President, and working with all parties to try to close the 
loopholes that have been identified this morning. Thank you. 
You are excused.
    Panel two. Panel, as you heard from panel one, we have a 
long tradition of swearing witnesses under oath. Do you have 
any problem with that? Do any of you want counsel, or have 
provided counsel? Okay. If you would stand and raise your right 
hand.
    [Witnesses sworn.]
    You are now sworn, under oath. People go to jail for doing 
otherwise, sometimes--hopefully, most of the time--hopefully, 
all the time.
    As I indicated before, we would like you to keep your 
comments to 5 minutes. All of your statement will be made part 
of the record. If you would like to summarize it, if is longer 
than that, that is fine.
    Dr. Atlas, we will start with you. Thank you.

     TESTIMONY OF RONALD M. ATLAS, CO-CHAIR, TASK FORCE ON 
BIOLOGICAL WEAPONS CONTROL, AMERICAN SOCIETY FOR MICROBIOLOGY; 
  DOROTHY B. PRESLAR, WASHINGTON PROJECT OFFICER, BIOLOGICAL 
     WEAPONS VERIFICATION PROJECT, FEDERATION OF AMERICAN 
   SCIENTISTS; AND NANCY D. CONNELL, ASSOCIATE PROFESSOR OF 
      MICROBIOLOGY AND MOLECULAR GENETICS, DEPARTMENT OF 
   MICROBIOLOGY, UNIVERSITY OF MEDICINE AND DENTISTRY OF NEW 
                             JERSEY

    Mr. Atlas. Thank you, Mr. Chairman. My testimony is 
presented on behalf of the American Society for Microbiology, 
which is the largest life science organization in the world. It 
has a membership of 43,000. The ASM appreciates the opportunity 
to testify today, and has submitted the longer statement for 
the record. I am just going to summarize some of the points.
    The ASM is acutely aware of the threat posed by the 
possible misuse of microbial agents as weapons of terror. 
Indeed, in the past, the ASM has assisted in the development of 
sound and effective public policies for the control of select 
agents, while avoiding undue inhibitions on scientific 
research. To this end, ASM has been an advocate for placing 
responsibility for the safe transfer of select microbial agents 
at the level of individual institutions; supported by 
Government oversight and monitoring to minimize risks, without 
inhibiting scientific inquiry and clinical diagnosis of 
disease.
    ASM contributed to the passage of section 511(d) of the 
Antiterrorism and Effective Death Penalty Act of 1996, which 
was intended to protect the dual public interests of safety and 
free and open scientific research through promulgation of rules 
that would implement a program of registration of institutions 
engaged in transfer of select agents. It is in the same spirit 
of recognizing and dealing with the threat of bioterrorism, 
while protecting essential research, that ASM testifies today.
    We have a couple of principles that we would like to put 
forward. First, we cannot discount the possibility that, as 
unfathomable as it may be to the civilized mind, terrorism may 
take the form of bioterrorism. Most certainly, therefore, 
Government and scientific communities are duty-bound to take 
every reasonable precaution to minimize any risks of terrorist 
use of select microbial agents.
    Second, even as we strive to prevent bioterrorism, we must 
candidly recognize that no set of regulations can provide 
absolute assurance that no act of bioterrorism will ever occur. 
Therefore, as we strive to prevent such acts, we must have a 
duty to pursue research aimed at developing the most effective 
possible responses to such bioterrorism acts. Research and 
public health responses related to effectively combatting an 
act of terror are a critical component of the public policy 
response to the threat of bioterrorism.
    Third, while the possibility of a future act of biological 
terrorism is a terrible threat, scourge of infectious diseases 
is a terrible reality that daily takes the lives of thousands 
of Americans, and tens of thousands around the world. 
Infectious diseases are now the third leading cause of death in 
the United States, and the leading cause of death in the world. 
Responding to the threat of terror, therefore, we must minimize 
any adverse impact on basic bioclinical and diagnostic research 
related to infectious diseases.
    Past legislation, certainly, has recognized the need for 
balancing these concerns. Congress and Federal agencies have 
appreciated these competing considerations, and have sought to 
minimize interference with research and the transfer of 
clinical specimens for patient diagnosis through measures 
recognizing the appropriate exemptions in regulating the 
handling of infectious microorganisms. We know that such 
balancing will continue. The ASM is committed to providing the 
available assistance in achieving balance and effective policy.
    The ASM supports measures to prohibit possession of listed 
biological agents, unless they are held for purposes that are 
in the public interest, and the cultures are maintained under 
appropriate biosafety conditions. Accordingly, the ASM supports 
extending the current CDC regulations covering the shipment of 
listed agents to include possessions of cultures of those 
agents, following the principles that are outlined.
    First, governmental responsibility for establishing, 
implementing, and monitoring programs related to biosafety 
should remain with the Department of Health and Human Services, 
and the CDC. The DHHS and CDC possess institutional knowledge 
and expertise related to issues of biosafety, and the 
designation, transportation, storage and use of select agents. 
The CDC is well-qualified to balance the need for biosafety 
regulation; the critical need for scientific research, and 
clinical and public health activities directed at the 
prevention, treatment, and cure of infectious diseases.
    Any expansion, though, of existing duties will require 
additional financial and other resources by the CDC. Based on 
surveys that we have performed, we estimate that there are 
approximately 300 institutions possessing select agents. 
Approximately half of those institutions are currently 
registered with the CDC, pursuant to existing law. Registration 
of additional institutions would impose new expense and 
resource burdens on the CDC.
    Second, focus must be maintained on the legitimate 
important and fundamental issues related to biosafety. As in 
other areas concerning biological, chemical and radiological 
safety, focus for ensuring safety should be on the institution.
    Third, we must recognize that we are dealing with naturally 
occurring organisms, and that cause of these diseases will be 
found with organisms that occur in nature. We want to make sure 
that possession does not extend to individuals who become ill 
from disease, or to those who are involved in the isolation for 
organisms for diagnostic purposes.
    In conclusion, Congress should recognize the need to deal 
with the threat of biological terrorism will be an on-going 
duty for the indefinite future, and will continue to require 
balancing competing considerations. Congress, acting through 
the DHSS and CDC, should provide for continuing consultation 
with the scientific community regarding the substance and 
procedures and regulations governing select agents. ASM is 
committed to working with the Congress and the Federal agencies 
to protect the public against the threat of bioterrorism, while 
engaging in rigorous research aimed at improving biomedical 
knowledge of disease and our clinical diagnosis and treatment 
of those diseases. Thank you, Mr. Chairman.
    [The prepared statement of Ronald M. Atlas follows:]
    Prepared Statement of Ronald M. Atlas, Co-Chair, Task Force on 
     Biological Weapons Control, American Society for Microbiology
    Thank you for inviting the American Society for Microbiology (ASM) 
to discuss issues related to the adequacy of federal law relating to 
dangerous biological agents. The ASM is the largest single life science 
society in the world with a membership of 42,000, and represents a 
broad spectrum of subdisciplines, including medical microbiology, 
applied and environmental microbiology, virology, immunology and 
clinical and public health microbiology. The Society's mission is to 
enhance microbiology worldwide 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.
    The ASM has a long history of bringing scientific, educational and 
technical expertise to bear on the safe study, handling and exchange of 
pathogenic microorganisms. The exchange of scientific information, 
including microbial strains and cultures, among scientists is 
absolutely essential to progress in all areas of research in 
microbiology. The ASM understands the unique nature of microbiology 
laboratories, the need for safety precautions in research with 
infectious agents and the absolute necessity for maintaining the 
highest qualifications for trained laboratory personnel. The ASM 
conducts education and training programs, as well as publication of 
material related to shipping and handling of human pathogens. Through 
its Public and Scientific Affairs Board, the ASM provides advice to 
government agencies and to Congress concerning technical and policy 
issues arising from control of biological weapons. The Society's Task 
Force on Biological Weapons Control assists the government on 
scientific issues related to the verification of the Biological Weapons 
Convention (BWC).
    The ASM is acutely aware of the threat posed by the possible misuse 
of microbial agents as weapons of terror. Concerns that bioterrorists 
will acquire and misuse microorganisms as weapons have resulted in 
stricter controls on the possession, transfer and use of biological 
agents to restrict access to only legitimate and qualified 
institutions, laboratories and scientists. Over the past 10 years, the 
ASM has worked with the Department of Health and Human Services (DHHS), 
the Centers for Disease Control and Prevention (CDC), the Department of 
Agriculture (USDA) and Congress to develop and establish legislation 
and regulations that are based on the key 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 has been an 
advocate of placing responsibility for the safe transfer of select 
agents at the level of individual institutions supported by government 
oversight and monitoring to minimize risks without inhibiting 
scientific research.
    The ASM notes that national security efforts to control biological 
weapons require that the United States increase biodefense and public 
health capabilities at the same time that it tries to develop 
safeguards to prevent the misuse of biological agents to harm the 
public health. Limiting the threat of bioterrorism includes reducing 
access to biological agents that might be used as weapons; however, 
combating infectious diseases and increasing medical preparedness 
against bioterrorism necessitates increasing biodefense, biomedical and 
other life sciences research, including work on the same ``threat'' 
agents that could be used as biological weapons. As safeguards are 
developed, we must ensure that biomedical research, public health and 
clinical diagnostic activities are not inhibited or we risk 
jeopardizing the public's health and welfare.
Legal and Regulatory Protections have been Established
    Congress already has established a legal and regulatory framework 
to prevent the illegitimate use of toxins and infectious agents, 
outlawing virtually every step that would be necessary for the 
production and use of biological weapons. In doing so it has balanced 
assuring the availability of materials to the scientific and medical 
community for legitimate research purposes with preventing access to 
these agents for bioterrorism. For instance, the 1989 Biological 
Weapons Act authorizes the government to apply for a warrant to seize 
any biological agent, toxin, or delivery system that has no apparent 
justification for peaceful purposes, but exempts agents used for 
prophylactic, protective, or other peaceful purposes. Prosecution under 
this statute requires the government to prove that an individual did 
not intend to use the biological agents or toxins in a peaceful manner. 
The law also enables federal officials to intervene rapidly in cases of 
suspected violations, thereby decreasing the likelihood of bioterrorism 
while protecting legitimate scientific endeavors, such as biomedical 
research and diagnosis of infectious diseases.
    The Antiterrorism and Effective Death Penalty Act of 1996 (the Act) 
broadens penalties for development of biological weapons and 
illegitimate uses of microorganisms to spread disease. ASM testified 
before the 104th Congress with respect to the control of the transfer 
of select agents that ``have the potential to pose a severe threat to 
public health and safety . . .'' and contributed to the passage of 
Section 511(d) of the Act. The Act was intended to protect dual public 
interests of safety and free and open scientific research through 
promulgation of rules that would implement a program of registration of 
institutions engaging in the transfer of select agents. The transport 
of clinical specimens for diagnostic and verification purposes are 
exempt, although isolates of agents from clinical specimens must be 
destroyed or sent to an approved repository after diagnostic procedures 
are completed. The CDC is responsible for controlling shipment of those 
pathogens and toxins that are determined to be most likely for 
potential misuse as biological weapons. The ASM believes the CDC 
regulatory controls provide a sound approach to safeguard select agents 
from inappropriate use and should serve as a worldwide model for 
regulating shipment of these agents.
    In April 22, 1998 testimony before the Senate Subcommittee on 
Technology, Terrorism and Government Information Committee on the 
Judiciary and Select Committee on Intelligence, Attorney General Janet 
Reno stated that ``mere possession of a biological agent is not a crime 
under federal law unless there is proof of its intended use as a 
weapon, notwithstanding the existence of factors, such as lack of 
scientific training, felony record, or mental instability, which raise 
significant questions concerning the individual's ultimate reason for 
possessing the agent.'' She, like other law enforcement officials, are 
troubled by the fact that someone can possess a biological agent that 
could be used as a weapon and not be in violation of a law unless one 
can establish intent. It is our understanding that the Department of 
Justice and other federal agencies have reviewed federal criminal 
statutes that could be expanded to make possession of certain 
biological agents illegal.
Safety and Security Measures Must be Balanced to Protect Biomedical 
        Research and Clinical Diagnostic Programs
    The ASM agrees that enhancing security and safety is a critical 
necessity when bioterrorism poses a credible threat to society. 
However, proposals intended to promote safety should not pose a threat 
to biomedical or other life sciences research and clinical diagnostic 
activities that are essential for public health. Unintended 
consequences could stifle the free exchange of microbial cultures among 
members of the scientific community and could even drive some 
microbiologists away from important areas of research. Ironically, 
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. A key point is 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.
    Dealing with the threatened misuse of microorganisms, therefore, 
will require thoughtful consideration and careful balancing of three 
compelling public policy interests.
    First, we must acknowledge the terrible reality of terrorism within 
the United States and abroad from both foreign and United States 
origins. We cannot discount the possibility that, as unfathomable as it 
may be to the civilized mind, terrorism may take the form of 
bioterrorism. Most certainly, therefore, the government and scientific 
communities are duty bound to take every reasonable precaution to 
minimize any risk of terrorist use of microorganisms. The ASM is taking 
a proactive role in this regard.
    Second, even as we strive to prevent bioterrorism, we must candidly 
recognize that no set of regulations can provide absolute assurance 
that no act of bioterrorism will ever occur. Therefore, as we strive to 
prevent such acts, 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.
    Third, while the possibility of a future act of biological 
terrorism is a terrible threat with which we must and will deal, the 
scourge of infectious diseases is a terrible reality that daily takes 
the lives of thousands of Americans and tens of thousands around the 
world. Infectious diseases are now the third leading cause of death in 
the United States. Research on the prevention and treatment of such 
diseases is critical to the well being of our entire population. In 
responding to the threat of terror, therefore, we must minimize any 
adverse impact upon vital clinical and diagnostic research related to 
infectious diseases.
    Congress and federal agencies have appreciated these competing 
considerations and have sought to minimize interference with research 
through such measures as recognizing appropriate exemptions in 
regulating the handling of pathogenic microorganisms. As we have 
stated, past legislation has recognized the need for balancing these 
concerns. We know that such balancing will continue, and the ASM is 
committed to providing all available assistance in achieving balanced 
and effective responses to the threat to the public welfare.
ASM Supports Measures to Increase Safeguards Against Biological 
        Terrorism
    The ASM supports making it more difficult for bioterrorists to 
acquire agents that could be used as biological weapons and to make it 
easier for law enforcement officials to apprehend and to prosecute 
those who would misuse microorganisms and the science of microbiology. 
The ASM code of conduct specifies that microorganisms and the science 
of microbiology should be used only for purposes that benefit humankind 
and bioterrorism certainly is inimical to the aims of the ASM and its 
members. The ASM established its Task Force on Biological Weapons to 
assist the government and the scientific and biomedical communities in 
taking responsible actions that would lower the risks of biological 
warfare and bioterrorism.
    The ASM supports measures to prohibit possession of listed 
biological agents or listed toxins unless they are held for legitimate 
purposes and maintained under appropriate biosafety conditions. 
Accordingly, the ASM supports extending the current regulations 
implemented by the CDC to oversee the shipment of listed agents to 
include possession of cultures of those agents.
    Although the ASM will not offer specific proposals today, we do 
think it will be useful to outline certain basic principles that we 
believe should be considered:
    First, governmental responsibility for establishing, implementing, 
and monitoring programs related to biosafety should remain with the 
Department of Health and Human Services and CDC for human health and 
the USDA for animal and plant health. The CDC possesses institutional 
knowledge and expertise related to issues of biosafety and the 
designation, transportation, storage and use of select agents. The CDC 
is well qualified to balance the real need for biosafety regulation 
with the critical need for scientific research, especially clinical and 
diagnostic research for the prevention, treatment and cure of 
infectious diseases.
    The CDC's responsibilities should include the duties to:

1. Continue to establish and periodically revise the list of select 
        agents; and
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.
    Congress and the Administration must recognize that any expansion 
of existing regulations will require additional financial and other 
resources by the CDC. Based upon surveys that ASM has performed, we 
estimate that approximately 300 institutions possess select agents. 
Approximately half of those institutions are currently registered with 
the CDC pursuant to existing law. Registration of an additional 150 
institutions, therefore, would impose additional expense and resource 
burdens upon the CDC that should be recognized and funded to ensure the 
timely and complete fulfillment of the CDC's critical mission.
    Second, Congress, the CDC, and any other relevant governmental 
agencies must maintain their focus on the legitimate, important, and 
fundamental issues related to biosafety. In this regard, biosafety 
initiatives should be directed toward, and focused on institutions that 
utilize select agents for scientific purposes, regardless whether such 
institutions are in the academic, commercial, or governmental sectors. 
As in other areas concerning biological, chemical, and radiological 
safety, the focus for ensuring safety should be on the institution. The 
institution rather than any individual scientist should be responsible 
for registering possession and maintaining the proper biosafety 
conditions for storage and usage of the agent.
    In this context, ASM supports 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. Institutions and individuals, thus, would be prohibited from 
possessing cultures of select agents unless the agents are maintained 
under appropriate biosafety conditions.
    The DHHS/CDC, acting in cooperation with the scientific and 
biomedical communities, and with public notice and input, should 
establish the rules and provide for governmental monitoring. However, 
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.
    These institutional responsibilities include assuring safety 
through proper procedures and equipment and through training of 
personnel. Thus, the institution would bear the responsibility for 
training employees regarding the biosafety requirements, including the 
absolute necessity for following those requirements, and 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 will fulfill all 
governmental requirements related to select agents. The institutions 
would be required to maintain records of authorized users and to ensure 
that they are properly trained as is currently the case for work with 
radioisotopes. Intentional removal of select agents from a registered 
facility would subject the individual to criminal sanctions.
    Third, Congress and the CDC must balance the public interests of 
minimizing the threat of bioterrorism and assuring vigorous scientific 
research, especially research relating to clinical and diagnostic 
methods and to protecting the nation's food supply. We must recognize 
that we are dealing with naturally occurring organisms that cause 
natural diseases. The focus should be on cultures of biological agents 
and quantities of toxins on the CDC select agent list in order to 
address any problem arising from an individual who may unknowingly pick 
up a dead deer mouse with Hantavirus, a handful of soil with Bacillus 
anthracis, a jar of honey with Clostridium botulinum, or contract an 
infectious disease with one of the select agents, and who could be in 
technical violation of a law prohibiting possession. Because 
microorganisms, including listed agents, are invisible and widely 
distributed, there is no way of knowing what you might possess unless 
you culture the organisms or use sophisticated molecular diagnostic 
procedures.
    The CDC, working with the scientific community, should develop a 
comprehensive definition of a culture of a biological agent that would 
include microorganisms growing in artificial media, animal cells, and 
preserved viable materials from such cultures, which are the materials 
of concern.
    Fourth, Congress should recognize that the need to deal with the 
threat of biological terrorism will be an ongoing duty for the 
indefinite future and will continually require balancing competing 
considerations as discussed in our earlier testimony. Therefore, 
Congress, acting through the DHHS and CDC, should provide for 
continuing consultation with the scientific and biomedical communities 
regarding the substance and procedures of regulations governing select 
agents. The CDC should be empowered to act swiftly to adjust 
definitions, substantive duties, and procedural requirements to the 
inevitable changes resulting from scientific research. ASM is committed 
to working with Congress and the DHHS and CDC to protect against 
threats of terrorism while engaging in vigorous research for the 
betterment of humankind.

    Mr. Upton. Thank you.
    Ms. Preslar.

                 TESTIMONY OF DOROTHY B. PRESLAR

    Ms. Preslar. Thank you, Mr. Chairman, and members of this 
committee. On behalf of the Federation of American Scientists, 
I am pleased to be here today, and hope that the testimony I 
bring will assist your efforts to control the possession and 
transfer of certain highly pathogenic and toxic agents.
    For any of you who may not be familiar with the Federation 
of American Scientists, it was founded in 1945 by Manhattan 
Project Scientists to promote the peaceful and humanitarian 
uses of the nuclear technology. Over the past half-century, we 
have addressed many arms control issues. In the last decade, we 
have started initiatives in other areas of global security, 
such as the threat of infectious disease, food production, 
energy, and the environment.
    Today I speak in my statement for the FAS working group on 
biological weapons. This group has spent 10 years studying 
means to prevent the use of biologicals as weapons. I will 
speak, also, for myself as may be appropriate in a question and 
answer period.
    FAS supports efforts to raise the level of accountability 
for handling deadly pathogens and toxins. It is clear that both 
national security and public health will be served if these 
agents remain in secure environments at all times; and if 
facilities that work with them are held strictly responsible 
for their safe storage, proper handling, restricted access and 
closely monitored transfer.
    Our working group suggests to you the following measures 
that may assist in this work. One, extend the rules for 
registration to facilities that possess these select agents. 
Two, impose strict controls on possession by individuals, of 
any amount, of a select agent outside the confines of a 
registered facility, or any laboratory. Three, amend the 
exemption for select agents that are part of clinical specimens 
to require that clinical samples received for diagnostic 
reference or verification purposes, and any cultures derived 
from them, after the specific task has been accomplished must 
be disposed of properly in their entirety, or transferred in 
their entirety to a designated facility.
    Four, modify the CLIA exemption to require notification of 
CDC, or other Federal authority as appropriate in the future, 
when select agents are diagnosed from chemical samples. This 
would serve a dual purpose, serving as a sentinel system for 
outbreaks of diseases caused by these agents. Five, conduct an 
intensive education campaign aimed at research and laboratory 
personnel. We believe that greater accountability can be 
achieved by explaining the importance of regulations, and 
appealing to the civic responsibility of the scientific 
community. Appropriate education means include presentations 
and information booths at scientific conferences; mailings to 
institutions; notices in scientific publications, and inclusion 
in medical and science ethics courses at our colleges and 
universities.
    Six, we also would suggest that you address the potential 
for attack on the food production resources of the United 
States by terrorists. These might be political terrorists, or 
they might be economic terrorists, using animal and plant 
pathogens. In recent weeks, as you may know, the USDA officials 
have sounded a warning saying that such targeting is 
inevitable, in the long term. A number of animal pathogens are 
already on the select agent list, because they are zoonoses, or 
diseases that affect both animals and humans. Considering the 
possible impact on food production, and also our food trade 
globally, that could result from synchronized attacks on 
cattle, poultry, pigs, corn, wheat, and soybeans, in the short 
term; our food export industry could be seriously affected. 
There might be shortages, also, in the United States. More 
importantly, in some ways, is that long-term fear can be 
created in these incidences.
    Last, develop and implement technologies for detection for 
proactive intervention, so as not to rely solely on regulations 
and criminal statutes to prevent unauthorized possession of 
select agents. Thank you.
    [The prepared statement of Dorothy B. Preslar follows:]
   Prepared Statement of Dorothy B. Preslar, Federation of American 
                               Scientists
    Good morning. On behalf of the Federation of American Scientists, I 
am pleased to be here today and hope that the testimony that I bring 
will assist your efforts to control the possession and transfer of 
certain highly pathogenic and toxic agents.
    My name is Dorothy Braddock Preslar. Since 1994 I have served as 
the Washington project officer for our Biological Weapons Verification 
project and, since 1995, have directed a project to promote 
surveillance of animal diseases, particularly in developing countries. 
For any among you who may not be familiar with the Federation, it was 
founded in 1945 by Manhattan Project scientists to promote peaceful and 
humanitarian uses of the new nuclear technology. Our organization, 
sponsored by some 55 American Nobel Laureates, has addressed arms 
control issues for over a half century and has in the past decade 
undertaken initiatives on global security issues such as the threat of 
infectious diseases, food production, energy and the environment.
    Today, I will speak for the FAS Working Group on Biological 
Weapons, which has spent ten years studying means for preventing the 
use of biological agents as weapons, as well as for myself, as may be 
appropriate in the question period.
    FAS supports efforts to raise the level of accountability for 
handling deadly pathogens and toxins. It is clear that both national 
security and public health will be served if these agents remain in 
secure environments at all times and if facilities that work with them 
are held strictly responsible for their safe storage, proper handling, 
restricted access and closely monitored transfer.
    Our Working Group on Biological Weapons suggests the following 
measures:
    1. Extend the rules for registration of facilities that transfer or 
receive specified agents to include the registration of all facilities 
that possess them.
    2. Impose strict controls on possession by individuals of any 
amount of a select agent outside the confines of a registered facility, 
or any laboratory.
    3. Amend the exemption for select agents that are part of a 
clinical specimen to require that clinical samples received for 
diagnostic, reference or verification purposes, and any cultures 
derived from them, must after the specific task has been accomplished 
be disposed of properly in their entirety, or transferred in their 
entirety to a designated facility.
    4. Modify the CLIA exemption to require notification of CDC, and 
other federal authority as appropriate, when select agents are 
diagnosed from clinical samples. This would serve a dual purpose, 
serving as a sentinel system for outbreaks of diseases caused by these 
agents.
    5. Conduct an intensive education campaign aimed at research and 
laboratory personnel. We believe that greater accountability can be 
achieved by explaining the importance of the regulations and appealing 
to the civic responsibility of the scientific community. Appropriate 
educational means include presentations and information booths at 
scientific conferences, mailings to institutions, notices in scientific 
publications, and inclusion in medical and science ethics courses.
    6. Address the potential for attack on the food production 
resources of the U. S. by terrorists using animal and plant pathogens. 
In recent days, as you may know, USDA officials have sounded a warning, 
saying that such targeting is inevitable. A number of animal pathogens 
are already on the select agent list because they are zoonoses 
(diseases that affect both animals and humans). Considering, however, 
the possible impact on food production that could result from 
synchronized attacks on cattle, poultry, pigs, corn, wheat, and soya 
beans, in the short term our food export industry could be seriously 
affected and long-term fear could be created.
    7. Develop and implement detection technologies for pro-active 
intervention, so as not to rely solely on regulations and criminal 
statutes to prevent unauthorized possession of select agents.
    Thank you.

    Mr. Upton. Thank you.
    Dr. Connell. If you could just move that mike a little bit 
closer, that would be perfect.

                  TESTIMONY OF NANCY D. CONNELL

    Ms. Connell. I am assistant professor of microbiology at 
the University of Medicine and Dentistry, New Jersey Medical 
School, in Newark. I received my Ph.D. at Harvard Medical 
School. I am director of molecular microbacteriology at the New 
Jersey Medical School National TB Center. I have an appointment 
on my institution's biosafety committee.
    I am also a member of the ASM and FAS, but I come here 
today as a researcher in the front lines; someone who works 
with agents that, while are not directly listed--I work with 
multi-drug-resistant tuberculosis--many of the processes that 
we use in ensuring the safety and security of our TB strain, 
are applicable.
    My involvement in the topic of possession and control of 
pathogenic organisms and deadly toxins is, thus, a direct 
result of the work that I do. In addition, I have a 
longstanding interest and commitment to the development of the 
Biological Weapons Convention of 1972. I believe that the new 
climate of bioterrorist global threat demands a preventive role 
that bioscientists can now play. This is imperative.
    Our performing experiments with an airborne pathogens, such 
as multi-drug-resistant TB, has familiarized me with the kinds 
of security issues that we are dealing with today. For example, 
all exchanges of MTB strains, as well as biological products 
derived from them--proteins, DNA, and so forth--are subject to 
shipping codes that are established by the public health 
service regulations of etiologic agents. These practices, I 
should say, were easily incorporated into the smooth running of 
my own laboratory.
    Currently, there are a wide variety of Government 
regulations that dictate health and safety standards in 
scientific research institutions. These standards have greatly 
improved working conditions with respect to health and safety 
within academic research institutions. As a result of the 
combination of these oversight mechanisms, much of the 
groundwork required for the kinds of control we are discussing 
today, I think, are already in place.
    Now I appreciate section 511 regulations, the regulations 
established by CDC, with respect to the act; but would 
support--as my colleagues do--some broadening of their terms. I 
think we have actually touched on the same, so I will shorten 
presentation of my list.
    Certain facility exemptions. Before 1996, any facility that 
possesses these agents should be registered. There is no 
questions about that in my mind. Compliance. How can we ensure 
that all facilities comply? It is an important question. How 
can we interview, find out, or inspect all the facilities 
actually in the country to see whether they possess agents?
    As far as clinical laboratory exemptions--this is a 
contentious issue, of course. One-hundred-fifty-thousand new 
registrants would be very difficult to do. I think it is 
unworkable. But I do agree that the identification of a listed 
agent in any of these clinical labs should be immediately 
reported to CDC; and transferred, if necessary for further 
study, to a registered institution.
    And finally, individual possession. Of course that remains, 
as we have all been saying, outside the scope of the final 
rule. But individuals with access to these agents may well be 
the first link in the scenario that we are trying to prevent 
from occurring. Inappropriate transfer or possession of a 
listed agent would probably be the first event.
    Certainly, there is a long tradition of exchange of 
scientific materials between and among scientists--carrying a 
strain in your briefcase, for example. But the world is 
different now. Individuals who must carry these agents on their 
person must carry authorization--strict authorization--in 
writing.
    Responsibility of individual scientists. A recent survey of 
academic scientific research institutions carried out by Dr. 
Atlas revealed that two-thirds of academic institutions had no 
knowledge of the Biological Weapons Convention. I ask my 
medical students every year, ``How many of you have heard of 
Biological Weapons treaty?'' I call it a treaty so they know 
what it is. The numbers are slowly increasing.
    One might infer from this that many scientists are under-
informed with respect to issues to biological weapons, such as 
transfer, security, and disposal. Biological agents security 
issues should be included in existing ethics courses in all 
medical and graduate schools. Many such ethics courses, as you 
already know, are mandated by the NIH. So in addition, the 
topic should be incorporated into OSHA training. This is a way 
of distributing some of these responsibilities.
    I see some implications in addition to the purpose of the 
act. The public health sector communities in which these kinds 
of research facilities are located will be enhanced by stricter 
control of the whereabouts of these agents. Many of the 
organisms listed are among the growing list of emerging 
pathogens, which is a major global health problem. This 
tracking system will aid in CDC's efforts to track these kinds 
of outbreaks.
    Finally, the President has recently stressed the importance 
of the current negotiations to strengthen the 140-member 
Biological Weapons Convention. These negotiations should 
benefit from the demonstration of U.S. research facilities' and 
scientists' willingness to make accurate and timely 
declarations regarding these biological agents. Thank you, very 
much.
    [The prepared statement of Nancy D. Connell follows:]
    Prepared Statement of Nancy D. Connell, Assistant Professor of 
    Microbiology and Molecular Genetics, University of Medicine and 
Dentistry of New Jersey, New Jersey Medical School, New Jersey Medical 
                  School National Tuberculosis Center
    My name is Nancy Connell and I am an Assistant Professor of 
Microbiology at the University of Medicine and Dentistry-New Jersey 
Medical School in Newark, NJ. I received my Ph.D. at Harvard Medical 
School and my Postdoctoral training at Albert Einstein College of 
Medicine. UMDNJ is the largest public health sciences university in the 
nation, with three medical schools and schools of dentistry, nursing, 
health related professions, public health and graduate biomedical 
sciences. In addition, UMDNJ comprises a University-owned acute-care 
hospital, three core teaching hospitals, and a statewide system for 
managed care and over 100 health care and educational institutions 
state-wide. UMDNJ is home to the newly established International Center 
for Public Health, a strategic initiative that will create a world-
class infectious disease research and treatment complex at the 
University Heights Science Park in Newark, NJ. I am also Director of 
Molecular Mycobacteriology at the New Jersey Medical School National 
Tuberculosis Center, and a member of ASM. The focus of my research is 
the molecular genetics Mycobacterium tuberculosis, the organism that 
causes tuberculosis. My laboratory studies the molecular basis of 
pathogenicity and analyzes the genetic basis of drug resistance in this 
organism. My research program is supported by the National Institute of 
Allergy and Infectious Diseases of the National Institutes of Health 
(NIAID 2R21AI3443606A1). Crucial steps of my work must be performed in 
a Biosafety Level Three laboratory, often with multidrug resistant 
strains.
    My involvement in the topic of possession and control of pathogenic 
organisms and deadly toxins is a direct result of the work that I do. 
In addition, I have a long standing interest and concern in the 
development of the Biological Weapons Convention of 1972. In 1991, I 
traveled to the United Nations in Geneva and presented to the States 
Parties of the Convention a petition signed by several thousand 
signatures of scientists from around the globe. These scientists 
pledged not to engage in research that would knowingly result in the 
development of biological weapons. Thus, the role of scientists in 
preventing the use of biological weapons in a central theme in my 
professional activities.
Background.
    The possibility that certain biological and toxin agents could be 
used in domestic acts of terror has come under scrutiny in the wake of 
several national and international events, by now well known to you 
all. Many of these potential weapons agents are the focus of, or are 
used in, vital research programs. Section 511 of the Act (Public Law 
104-132) stipulates that the Department of Health and Human Services 
regulate the transfer of a number of such agents. The final version of 
these regulations, compiled by CDC (42 CFR 72.6--``Additional 
requirements for facilities transferring or receiving select agents'') 
went into effect April 15, 1997. All facilities either transferring or 
receiving organisms or toxins from among a list of 36 biological agents 
(species, genera or toxins) must register with the Select Agent 
Transfer Program administered by CDC. The regulations were originally 
designed to balance the protection of public safety without burdening 
biomedical research with excessive administrative and regulatory 
restrictions.
    Scientific institutions have been slow to enforce the stringent 
workplace safety standards adopted by industry. Currently, there are a 
wide variety of government regulations dictating health and safety 
standards in scientific research institutions. Among recent regulations 
impacting scientific research institutions are OSHA's ``Bloodborne 
Pathogens Standard'' and ``Occupational Exposure to Hazardous Chemicals 
in Laboratories Rule'' (also known as the Lab Standard). These 
standards have greatly improved working conditions with respect to 
health and safety within academic research laboratories. Federal, state 
and local agencies superintend the standards. As a result of these 
oversight mechanisms, much of the information required for the kinds of 
control we are discussing are already available within institutional 
biosafety and/or environmental health and safety offices.
    Addressing biological hazards directly are the joint CDC/NIH 
guidelines, outlining safe techniques for the storage, transport, 
manipulation and destruction of hazardous organisms in the laboratory. 
The descriptions of biosafety containment levels (BSL 1-4) found in the 
joint CDC/NIH guidelines parallel those found in a another oversight 
system, the NIH recombinant DNA (RDNA) guidelines. The NIH reserves the 
right to withhold funding from those institutions found not to be in 
reasonable compliance with the RDNA guidelines.
    These levels of control, monitoring and tracking are administered 
at each institution by the appropriate committee, such as the biosafety 
committee. In addition, most institutions have strict intellectual 
property laws that require accurate record of each and every unique 
biological construct (new strains of bacteria, viruses and cell lines; 
transgenic animals; specific pieces of DNA, etc.) that leaves or enters 
the laboratories. Finally, most institutions have risk management 
offices that are concerned with protection against litigation, which is 
a strong motivator for strict compliance with applicable regulations 
and guidelines.
    The current regulations established by CDC have been designed to 
ensure safe packaging, labeling and transport of infectious agents and 
to enable the tracking of these agents as they are transferred from 
facility to facility. These regulations do not impose undue burdens on 
the facilities or the investigators involved.
    I have some observations and suggested revisions for improving the 
regulations.
    1. Compliance. How can we ensure that all facilities comply if 
eligible? According to estimates made by the Federations of American 
Scientists, there are approximately 685 U.S. facilities working with 
agents currently listed by the Biological Weapons Convention 
(Federation of American Scientists, 1998). (There are a number of 
differences between the CDC list and the agents listed in the 
negotiations for a protocol for the BWC) I suggest that all research 
facilities should be recontacted on a biannual basis to ensure that 
there has been no change in status.
    2. Facility exemptions. Facilities not involved in actual transfer 
of listed agents are considered exempt. In other word, if a listed 
agent has been stored in a facility before April 15, 1997, registration 
is not required, until the agent is transferred out of the facility. 
Transfers of agents within single facilities are not subject to the 
regulations. Should these facilities not also be registered? There are 
obvious security breaches involved in any kind of transport of agents 
outside containment laboratories. I suggest that institutions currently 
possessing agents should be required to register, not only those 
engaged in transfer of listed agents. The security of listed agents 
must be enforced at all institutions, not just those shipping or 
receiving them.
    3. Clinical laboratory exemptions. In view of the huge numbers of 
clinical (i.e. non-research) laboratories engaged in diagnosis, 
reference and/or verification (estimated to be well over 100,000), 
registration of all these facilities would be an unworkable 
proposition. However, clinical samples are often the source of our most 
interesting isolates for basic research. These isolates may be 
transferred to already registered research facilities for further 
experimentation. Can these types of transfers be monitored without 
actually requiring regulation of the clinical lab that identified the 
agent? I propose that clinical labs should remain exempt but clear 
provisions should be included to ensure that upon diagnosis/
identification of select agents in a clinical sample, the lab must 
notify CDC. Isolates can still be sent out to an appropriate registered 
institution for expansion of culture, further examination, storage or 
appropriate disposal.
    4. Individual possession. Possession remains outside the scope of 
the final rule. But individuals with access to these agents may well be 
the first link in the scenario we are trying to prevent from occurring: 
inappropriate transfer/possession of a listed agent. Certainly there is 
a long tradition of exchange of scientific material among scientists. 
But the world is different now. Scientists and those working with them 
must learn to behave responsibly. On occasions when individual 
possession (i.e. by a worker) is necessary, that individual should be 
authorized in writing by the registered facilities sending and 
receiving the agent.
    5. Responsibility of individual scientists. A recent survey of 
academic scientific research institutions revealed that two-thirds of 
academic institutions had no knowledge of the Biological weapons 
Convention (Weller et al., 1998). One might infer from this that many 
scientists are underinformed with respect to the issues related to 
biological weapons such as transfer, security and disposal. Education: 
Biological weapons issues must be included in ethics courses in 
currently existing graduate programs and medical schools. The NIH 
mandates ethics course for students involved in NIH-funded training 
programs. In our Institution, for example, all students are required to 
take this ethics course. Biological and toxin weapons and their control 
should be among the required topics. In addition, the topic should be 
mandated to be part of biosafety/OSHA training.
Implications.
    The above comments are respectfully put forward as topics for 
discussion. In addition to the direct application of these issues to 
the problem of bioterrorism, there are several beneficial aspects that 
would accompany the strengthening of the Select Agent Transfer Program. 
First, the public health of the communities in which research 
facilities are located will be safeguarded by stricter control of the 
whereabouts of these agents. Second, many of the organisms listed are 
among the growing list of emerging pathogens. Endemic pathogens on the 
list may cause diseases not yet found on individual State Department's 
``reportable diseases'', and this tracking system would assist CDC to 
monitor outbreaks. Finally, the President has recently stressed the 
importance of the current negotiations to strengthen the 140-member 
Biological Weapons Convention. These negotiations will benefit from 
demonstration of US research facilities' and scientists' willingness to 
make accurate and timely declarations regarding thee biological agents.
Conclusions.
    Biomedical research has performed marvels for human health. Now it 
needs to do a simple thing: keep track of the whereabouts of disease-
causing microbes (microbial pathogens) studied in research laboratories 
and make sure that they are handled safely and securely stored. In 
general, these measures are carried out by professional safety officers 
and no undue burden need be placed on the researchers themselves. But 
for scientists who have chosen to devote their lives to the study and 
control of pathogenic microbes, preventing their spread in every way 
possible is just part of the job. This is clearly the critical moment 
for us and our research institutions to make sure that our houses are 
in order.
Acknowidegements.
    I would like to acknowledge the contributions of Mitchell Gayer, 
Paul Rubock, Theodore, Myatt, and Len Cole in the preparation of this 
testimony.

                               References

    Weller, R., Atlas, R., Lyu, C. W. and Wolters, C. A survey to 
assess the impact on academic institutions of a possible mandated 
declaration under the Biological and Toxin Weapons Convention (BWC). 
(Manuscript in preparation).
    Federation of American Scientists. Estimate of the Number of 
Declarable US Facilities. (1997).

    Mr. Upton. Thank you. You know the procedure for us up 
here. I will start my 5 minutes.
    I heard all of you say, both in your testimony and 
verbally, that there really is never a legitimate reason to 
possess biological agents outside of an improved, secure lab 
environment. Such possession really should be unlawful, is the 
bottom line. Ms. Preslar, what is your sense on the research 
community's compliance with the current CDC transfer 
regulations? Do you think there is 100 percent compliance, 50 
percent? What are your thoughts?
    Ms. Preslar. That is very difficult for me to assess. I do 
think that there have been successes in this. I think there 
have been more successes after the dropping of the fee, because 
$13,000 is quite high for an academic lab to cough up if they 
want to send a vial of something to a colleague in Oregon. 
Maybe that is not the right place to send it.
    I think there will continue to exist individual transfers 
to colleagues working on the same agents, both domestically and 
internationally, until such time as either the scientists are 
frightened to death of criminal prosecution; or frightened of 
losing their jobs at the institutions; or until they simply 
recognize that they have a responsibility to cooperate.
    Mr. Upton. Dr. Atlas you wrote in ASM News last year, and I 
quote here, ``The majority of microorganisms that could be used 
as biological warfare agents are freely circulated among 
scientists, and ordinarily may be obtained through these non-
documented, non-authenticated sources.'' Is that still your 
sense?
    Mr. Atlas. I think that if we talk about an organism that 
can cause disease, not a weapon of mass terror, then that is 
correct. We have the salmonellas--any number of organisms--that 
are freely transferred and are not regulated. I have no sense 
that anyone is violating the current statutory regulations for 
registration of shipment of listed agents. My conversations in 
the scientific community indicate, in fact, what has happened 
is that a number of individuals are simply not shipping. They 
are not exchanging.
    I think the point in the article that I wrote is that if 
you wanted to be a bioterrorist, you could find the materials 
freely in nature. You could obtain them. You would not have to 
register. You could, in fact, possess them. I think that the 
current discussion of how to tighten up the regulations would, 
in fact, potentially make it a crime to possess such agents 
outside duly authorized and appropriate institutions. I think 
that is really the critical thrust of where things seem to be 
going.
    Mr. Upton. So you would be very supportive, particularly of 
the first panel that was here and the movement that is being 
made along those lines?
    Mr. Atlas. I think I am very supportive of the movement 
toward the regulation of possession. Not having seen the 
administration's legislative proposal, however, the devil may 
be in the details. So I think I, and my colleagues, remain 
concerned, since we have not been at the table with respect to 
the details of that proposed legislation. We certainly have 
been consulted in general terms. I think we are comfortable 
with much of what is being discussed, generally. Although, 
again, we get very concerned when we get to the point of who 
really, legitimately can have access to a laboratory where 
agents are being employed.
    Mr. Upton. Okay. Thanks. We will have a second round here. 
Mr. Stupak.
    Mr. Stupak. Thank you, Mr. Chairman. If I may pick up on 
Dr. Atlas and Ms. Preslar, have your organizations been 
consulted by the administration in preparing their so-called 
package?
    Mr. Atlas. Informally we have had some discussions with 
individuals, from HHS in particular, who have been involved in 
those discussions. However, we have not been brought to the 
table for the actual discussions. We think that is a very 
important and missing step.
    Mr. Stupak. So you feel you should be consulted?
    Mr. Atlas. Yes.
    Mr. Stupak. Ms. Preslar?
    Ms. Preslar. Our organization has not; but then our 
organization was not consulted in the 1997 rule, either.
    Mr. Stupak. Okay. Do any of you in your own research work, 
work with special biological agents? Shaking of heads--that 
means ``no''? No one does.
    Ms. Connell. No.
    Mr. Stupak. Do any of you represent any institutions or 
companies that actually own laboratory facilities?
    Ms. Connell. No.
    Mr. Atlas. No.
    Mr. Stupak. Okay.
    Mr. Stupak. Ms. Preslar, you proposed there be strict 
controls, you said, on possession by individuals of any amount 
of select biological agents outside the confines of a 
registered facility, correct?
    Ms. Preslar. Right.
    Mr. Stupak. So then what is your opinion of possession of 
the agents by commercial courier: UPS, FedEx or mail system 
employees during shipping?
    Ms. Preslar. I think there ought to be closer monitoring. I 
think the tracking system ought to be special for these things. 
Although, I understand from the prior testimony when you do 
that, then you may indeed signal what the contents are of a 
package. I don't think we want to do that. One never knows who 
is coming across this package.
    You are absolutely right, from the prior panel, to suggest 
that after it leaves the doorway of lab and before it reaches 
the doorway of a second lab, anything can happen to it. It can 
be stolen. It can be lost. It can be damaged. The safe 
packaging--I am not sure if that was described. There are 
containers that are very resistant to tampering, and so forth.
    Mr. Stupak. Dr. Atlas, I think you testified that the 
Society of Microbiology worked on those transfer and shipping 
rules, and think they are adequate. But do you think that 
special biological agents should have less protection than the 
transferring or shipping of money?
    Mr. Atlas. Yes, in some ways. When you have a patient in a 
clinical situation and you isolate pathogen, it is of the 
utmost importance that we get that diagnostic specimen to an 
appropriate laboratory for diagnosis. If we are going to ever 
have a bioterrorist attack, what is going to be critical is 
that we carry-out the diagnosis.
    Mr. Stupak. You are talking about a clinical laboratory 
sample, right? We are not talking about special biological 
agents here, are we?
    Mr. Atlas. Well, but we are. In other words, if you have a 
patient who, in fact, is diagnosed with a disease. You have an 
envelope, as the FBI has brought to our hospital, with 
suspected spores of anthrax in it. One has to take appropriate 
quick steps to move that specimen.
    Mr. Stupak. That is for diagnosis and when you don't know 
what it is, right? I am talking about special biological agents 
that you do know what it is.
    Mr. Atlas. I guess what I am saying is that it is very hard 
in many situations to make that distinction between the 
clinical specimen and the biomedical research material. What 
has been critical to us is really the biosafety aspects of 
shipment.
    Mr. Stupak. You spoke in your testimony, again, about that 
natural infectious disease kills 17 million every year in the 
world, and are a much greater threat than future bioterrorism 
scenarios. I think where we are going--and I guess, where we 
are all trying to go--in very practical terms, at what point 
does Government regulation encumber the diagnosis and treatment 
effort?
    Mr. Atlas. If one had to, for example, pause for 24 hours 
while one obtained permits to make the shipment it would 
clearly inhibit the diagnosis. I don't think anyone wants to 
that. This is why there has been this exemption on the clinical 
isolation.
    With regard to other shipments, I think the broader issue, 
which has been touched upon by the first panel, and which ASM 
would support, is some greater consideration to the security 
aspect related to biosafety. We have been very concerned with 
avoiding exposures to individuals working with the organisms to 
anyone else in the public. With these select agents, it is 
appropriate for the CDC and other HHS organizations to work 
with the scientific community to better define the security 
arrangements, including the shipment aspects.
    Mr. Stupak. Are your comments more toward protection of the 
workers who are dealing with these in the labs?
    Mr. Atlas. I think it goes beyond that. It starts--and 
where it currently is at--is in the protection of the workers. 
I think there needs to be some additional consideration here 
given to maintaining the appropriate security of both the 
laboratory and the shipment.
    Mr. Stupak. Thank you.
    Mr. Upton. Thank you. Mr. Burr.
    Mr. Burr. Thank you, Mr. Chairman. Let me also take this 
opportunity to thank Dr. Ostroff and Dr. Raub for sticking 
around. I would just be curious--is there anybody here from the 
Department of Justice? Thank you. How about from the FBI, 
specifically? I know it is under your purview. My only concern 
is that they are not as interested to be here to hear the 
continuation of panel two. I think there has been some good 
information.
    I would also like to welcome Ms. Preslar. I notice that you 
are a Wake Forest graduate. I am always tickled to death to 
have those up here. I thought maybe our paths had crossed until 
I saw the cum laude and Phi Beta Kappa.
    I realized the chances were very slim.
    Ms. Preslar. I did tutor a lot of football players.
    Mr. Upton. It is even slimmer, yet.
    Mr. Burr. He is the wrong one to engage in something like 
this. Let me ask all three of you. I will assure you that this 
committee is not attempting to over burden the research 
community. We are not here to determine which agency is the 
right one, and what balance of law enforcement versus science 
should drive the decision.
    I have a tremendous amount of confidence in the CDC on just 
about everything. But I think it is legitimate for this 
committee to ask if we have given them an assignment that is 
acheiveable? So I would ask you. Have we given them, in this 
case, a task to carry out that you feel this is the most 
appropriate place for it to come from?
    Mr. Atlas. Simply, yes. I think that the overall mission of 
the CDC is to protect human health. That involves ensuring 
biosafety. In this case, it extends to deterrents of 
bioterrorism.
    Mr. Burr. Ms. Preslar?
    Ms. Preslar. Not entirely. I think that the ideal situation 
would be if you had an inter-agency situation. CDC is not 
equipped to do law enforcement, as was brought up in the last 
panel. Law enforcement is not able to have the sensibilities 
toward research work and know, actually, what they are dealing 
with half the time, unless they are trained well. So I would 
say that you would need input. You need OSHA input. You need 
academic laboratory input. You need industry input.
    My suggestion would be, if the United States is going down 
this path, that some thought be given to creating--not an NRC--
but a minuscule ``BRC,'' perhaps.
    Mr. Burr. Well, I have actually had two instances in the 
past several months in North Carolina of anthrax scares. One 
was an abortion clinic in Asheville, and another was a facility 
in Roanoke, Virginia. In both cases, the FBI did not call the 
CDC. They called a special operations medical team in Winston-
Salem, where a team went out to determine whether it was a 
valid threat. That sort of stimulates my questions, to some 
degree. Dr. Connell?
    Ms. Connell. I would say CDC, with input.
    Mr. Burr. With input from the agencies.
    Ms. Connell. That looks like that is happening.
    Mr. Burr. Ms. Preslar, in staff interviews you mentioned 
your concern that security and accountability is a significant 
problem at many labs, particularly hospitals and other academic 
labs, less so with pharmaceutical companies. Would you like to 
expand on that at all?
    Ms. Preslar. Academic labs and some institutional labs 
simply do not have the funds to provide total security. We know 
that. Also in academic labs there is, probably, a more relaxed 
atmosphere when dealing with these things. It is because these 
environments have been, in some ways, rather sacrosanct. These 
people have not had to worry about bioterrorism.
    Mr. Burr. Would they know if there was a theft?
    Ms. Preslar. Possibly no. It depends on the inventory 
control aspects the place.
    Mr. Burr. Dr. Connell, you stated in your testimony that 
academia has not done as good a job as private commercial labs, 
with respect to safety and security. Can you expand on that?
    Ms. Connell. I think there has been a lag in the 
implementation of a lot these kinds of things. This is a 
different issue. We are talking about safety.
    Mr. Burr. Let me just say, before you answer, I think it 
gets at the heart of the thought process that they put into it. 
Because safety, to some degree, is prerequisite to security.
    Ms. Connell. That is true. So I do think there has been a 
lag, but I do think they are catching up. I think that now 
academic institutions are actually slapped with fines for 
noncompliance in various areas of safety, certainly by the NRC, 
by OSHA, and so forth.
    Mr. Burr. Does that encourage or discourage additional 
research?
    Ms. Connell. I think it is irrelevant. This is a point that 
I would like to make. I think that a committed principal 
investigator who wants to work on an organism will work on the 
organism, and will go through the necessary paperwork that is 
required.
    Mr. Burr. How many times would an academic lab be fined 
before they might restrict what their researchers have access 
to?
    Ms. Connell. Fined by what?
    Mr. Burr. You mentioned the fines.
    Ms. Connell. NRC fine, for example. A security violation 
for the NRC for leaving a small vial of P32 unattended----
    Mr. Burr. We are at a disadvantage because we don't know 
what will be in the crime bill. There might be some monetary 
approaches that they take toward lack of security of safety. I 
thought that might have been what you were suggesting.
    Ms. Connell. Yes. There is definitely been a response. NRC 
has been able to implement these strict security guidelines 
over the past 5 years that have been very carefully followed. 
Yes, the institutions have been fined.
    Mr. Burr. Dr. Atlas, you have written that security should 
be increased at laboratories that legitimately use and store 
potentially dangerous microbial agents. Can you be more 
specific about what types of measures your are talking about, 
and what types of deficiencies you have observed that lead up 
to this suggestion?
    Mr. Atlas. I think there is a need, first, for educational 
awareness that security is necessary with these agents. Locked 
laboratories; limited access to laboratories; knowing who 
enters and has access to materials, I see as part of a 
biosafety requirement. It then extends to the security issue.
    To date, in academia at least, we have left our 
laboratories largely open, regardless of the organisms that we 
have in them. We have common refrigerators and storerooms 
where, if it is frozen and sealed in a vial, it is concerned 
safe. Anyone may have access to it.
    We do not have centralized inventories at most academic 
institutions that would allow a biosafety officer--many 
academic institutions don't have biosafety officers. All those, 
I think, can be strengthened and should be strengthened. I 
think that the actions of this committee in bringing this to 
greater attention will help universities focus their attention 
where it needs to be.
    Mr. Burr. Let me just make one last comment. It gets at the 
heart of, I think, what Mr. Stupak was at. Am I off base in 
seeing a distinct difference between the diagnosis of an 
illness, or the exposure versus the research of biologic 
agents? Are they not two, distinctly different things?
    Mr. Atlas. They are two distinct processes, but in both you 
wind up with possession of the organism.
    Mr. Burr. I would suggest that with the diagnosis side, 
there is a way within the CDC and HHS that we can address the 
immediate access needs to that; but treat the research side 
with somewhat different controls that are not as time-
sensitive.
    Mr. Atlas. That is correct.
    Mr. Burr. I thank this panel. I thank you, Mr. Chairman for 
you leniency on that quick clock. I know you shorted me some 
time because of your bad eyesight.
    I yield back.
    Mr. Upton. I just have a couple of follow-up questions. Dr. 
Atlas, you said in your statement that actually a vast majority 
of labs don't keep track of their inventory. Is that correct--
in the study?
    Mr. Atlas. A vast majority of academic institutions report 
that they have no centralized inventory. They don't know what 
they have. Anecdotally, I was chairing a department at our 
medical school and I can tell you, I didn't know what existed 
in our department.
    Mr. Upton. I take it based on that conclusion that you 
believe we ought to have some inventory checks or some way to 
gauge exactly what is there. Should the CDC be the ones to keep 
track of that? What recommendation would you make?
    Mr. Atlas. I think that institutional responsibility is 
critical. I think that what needs to happen, if we move toward 
possession as opposed to just shipment, is that we place the 
responsibility on the institution for maintaining the 
appropriate biosafety. That will include knowing what they 
have; where it is; who is using it, and those records could 
certainly be made available to CDC on inspections. That would 
be an extension of the current inspections. As Dr. Richmond 
indicated, there will be instances on a CDC inspection, they 
decide that a given laboratory is not meeting the appropriate 
requirements. I think it has to be institutional responsibility 
to maintain those standards.
    Mr. Upton. Dr. Connell.
    Ms. Connell. If I could make a comment. It is my 
understanding that the NIH Recombinant DNA Advisory Committee 
mandated that any institution using recombinant DNA have a 
biosafety officer; and have a record in each lab of what 
recombinant molecules are being produced, and so forth. So yes, 
straight organisms don't fall under that purview and I think it 
should be extended.
    Mr. Upton. What about background checks? You think the 
institution should require a background check in terms of past 
felony convictions, or something along that line, for folks 
handling these things?
    Mr. Atlas. I think that is where I have a problem, as a 
scientist, saying what the appropriate place for background 
checks is.
    Mr. Upton. Maybe you could ask if they have a firearm. If 
they have a firearm, they are supposed to have had that, right? 
At least when the Senate is done this week.
    Mr. Atlas. I guess where I have my problem is that I don't 
see that it is ever appropriate for individuals to really 
possess. I think institutions possess. Individuals have access 
and use within the facilities of an institution. It will be a 
major burden, I suspect, depending on the sort of background 
check. It may be very difficult in various States and 
institutions to deny employment for individuals in our 
universities and other facilities.
    Again, not knowing what is being proposed or even 
discussed, it seems to change in rumor each day as to what the 
legislation may or may not include. It is very difficult to 
comment on how that really would impact, or how workable that 
would be. I have concerns. On the other hand, no, I don't want 
someone with access to pathogens who has a propensity for 
misusing.
    Mr. Upton. I would just like to say as I wind up my time, 
when we do see this proposal, my sense is that our committee 
will get a piece of the referral of that legislation. I 
certainly would like to stay in touch with the three of you and 
get your comments once we see that in written form. If you 
wouldn't mind doing that, that would be terrific. With that, 
Mr. Stupak.
    Mr. Stupak. Thank you, Mr. Chairman. Let me just ask some 
questions along those lines that the Chairman was asking.
    The President's proposal--one of them--said that it would 
ban violent felons and fugitives from possessing these agents. 
Any of you know of violent felons or fugitives working in the 
labs? I mean, not currently, but in the past.
    Ms. Preslar. Well, I don't think that is the question. I 
think the question is how can you tell they are violent felons?
    Mr. Stupak. Exactly right. The violent felons, of course, 
we have title I crimes, which are considered violent. I guess 
that is the definition. But the point I am trying to make is 
that while the proposal sounds real good and everyone says, 
``Yeah, let's do it,'' you just don't have fugitives and 
violent felons working in labs.
    Ms. Preslar. You could have. It is possible.
    Mr. Stupak. Okay. Then we should do some background checks 
on everyone. Is that what you are saying?
    Ms. Preslar. I am not expert on employment law, or labor 
law. But is it not still acceptable on an application to ask if 
you have ever been convicted of a felony?
    Mr. Stupak. You have to be careful there.
    Ms. Preslar. You can no longer ask?
    Mr. Stupak. You can ask if you have been convicted.
    Ms. Preslar. Not arrested, but convicted.
    Mr. Stupak. Yes. So are you saying the institution should 
have that responsibility?
    Ms. Preslar. I think the institution should ask the 
question. I think that puts people on notice regarding their 
obligation.
    Mr. Stupak. Dr. Atlas, would you agree with those?
    Mr. Atlas. I don't know. I really am not sure what the 
institutional responsibility ought to be in that instant. In 
part, that comes from my lack of knowledge of labor law and how 
institutions operate.
    Mr. Stupak. I believe the FBI had actually suggested, too, 
along these lines: mental instability; drug and alcohol 
problems; financial problems. These would be incentives, if you 
will, have people put these agents out or monetarily gain from 
them because of some deficiency in their own character. Should 
we do background checks on folks who work there to make sure 
they don't have financial difficulties, instabilities, or 
alcohol or drug problems?
    Mr. Atlas. Now you are raising the issues where, as I said, 
the devil is in the details, and where my concerns are. We have 
also heard that people have marital problems of various types 
may be excluded from the labs.
    There are endless rumors. I don't know how to respond to 
those rumors other than to say that I am concerned. When the 
actual legislation comes forward we would welcome the 
opportunity to comment back to the appropriate committees as to 
what the likely impact would be.
    Mr. Stupak. Should all foreign nationals be banned from the 
labs? Should they undergo background checks and things like 
that?
    Mr. Atlas. I think that is the one we have heard that gives 
me the biggest problem in that I believe that 25-30 percent of 
our graduate students working in labs are foreign nationals 
that we continuously recruit. I understand there are security 
concerns. But in many cases, a number of these agents are 
exotic diseases to the United States. We are carrying out 
research to help in Africa or elsewhere. It behooves us, then, 
to have researchers from those countries who will bear the 
burden of carrying forth on that to come to our labs, be it the 
CDC or elsewhere, and work with our scientists. I would not 
want to ban them from research on the agents that are really 
their concern more than ours.
    Mr. Stupak. Let me ask this. Let me ask in a series of 
questions, if I may, and try to wrap it up here.
    I am still struggling with what kind of security to we want 
at these labs with special biological agents. I am talking 
about special biological agents, not biosafety measures. I am 
talking about physical security.
    Should new labs be built on a much higher level of physical 
security, similar to our nuclear weapons? Should all these labs 
have 24-hour armed, trained guards and surveillance cameras? 
Should all persons with access to the labs undergo checks for 
their criminal records; mental stability; drug, alcohol, gaming 
addictions, credit cards, political activities, intelligence--I 
mean, we could go on and on?
    What kind of security would you be comfortable with? What 
do you think we could do and still balance the research that 
you are trying to do to stop the death of 17 million people a 
year?
    Saved by the bell. I know I threw a lot of things out 
there. But, where do we go with this stuff?
    Mr. Atlas. The answer is, I think, in part both from the 
biosafety and the security issue that having a more limited 
access to a number of laboratories where they are not common, 
shared facilities is appropriate. Armed guards seems excessive. 
I say that, in part, because you have to recognize that for 
most of these agents, you always go and obtain them from 
nature.
    So the question becomes one of balance. How far do you go 
in locking the doors and simply forcing them out into a field 
to isolate the organism?
    Mr. Stupak. See, my concern is that what we have heard thus 
far from the panels, I think, has been like if we make it 
crime, let's make it a crime. Then we have control of the 
situation. It doesn't work. It is not just making it a crime, 
as you said. They can grow it. They can do other things to 
obtain it. I am trying to get the safety measures, internally, 
so that it doesn't get out. I agree with you that there are 
some problems there. But you can't simply make something a 
crime and it goes away. If you make it a crime, then we have 
law enforcement running labs, not scientists.
    Ms. Connell. Most of the agents have worked with inside 
biosafety level three and above--containment facilities which 
are totally contained.
    Ms. Preslar. I just wanted to say that I think that the 
biosafety and the bioterrorism aspects of this are intertwined. 
The more we talk about bioterrorism, the more we indicate that 
there is a terrorist standing on every street corner, or a 
potential terrorist, the more important it is to prevent 
accidental release of any of these select agents. Because, even 
if you have a unnatural outbreak from an accidental release, 
the terrorist aspects of that in terms of the population 
increases exponentially.
    Mr. Stupak. Thank you.
    Mr. Upton. Well, again we thank you for testimony. We look 
forward to hearing back from you once we see the administration 
proposal. We thank you very, very much for spending the time 
with us today. We are all excused.
    [Whereupon, at 12:21 p.m., the subcommittee was adjourned.]
    [Additional material submitted for the record follows:]
Responses to Questions for the Record from Rep. Henry Waxman by Stephen 
                            M. Ostroff, M.D.
    Question 1. Dr. Ostroff's supervisor, Dr. James Hughes, testified 
on April 20 in the Senate on bioterrorism. He identified four CDC 
priorities to which $41 million are being allocated: 1) detection of 
unusual events, 2) investigation and containment of outbreaks, 3) 
laboratory diagnosis, and 4) communication.
    These four priorities are consistent with CDC's traditional 
functions and mission. Aren't new regulatory responsibilities, such as 
background checks and laboratory inspections, at odds with CDC's 
existing priorities for strengthening the national public health 
infrastructure? Wouldn't such new responsibilities threaten to divert 
CDC resources and staff from these priorities?
    Answer 1. A primary role of CDC is prompt recognition of disease 
threats whether they are naturally occurring or intentional. This 
requires careful monitoring by effective disease surveillance systems, 
backed by the capacity to investigate and control outbreaks of a 
variety of health problems in a timely manner. As the nation's disease 
prevention and control agency, it is CDC's responsibility to provide 
national leadership in the public health and medical communities in a 
concerted effort to detect, diagnose, respond to, and prevent 
illnesses, including those that occur as a result of a deliberate 
release of biological or chemical agents. This task is an integral part 
of CDC's overall mission to monitor the health of the U.S. population.
    When considering whether to add law enforcement duties to an agency 
such as CDC, several issues should be considered. First, CDC is a not a 
law enforcement agency, and such responsibilities are considerably 
beyond CDC's expertise and mission. Second, CDC does not have an 
infrastructure to efficiently implement and administer such 
requirements. Such requirements would divert expertise from our more 
traditional high priority tasks such as surveillance and outbreak 
investigation. Third, such activities could jeopardize the independent 
scientific credibility of CDC when it is recognized that CDC is 
policing external organizations, institutions and individuals. The same 
non-governmental researchers that we must collaborate with on a 
voluntary basis in order to solve complex scientific issues, whether 
they pertain to bioterrorism or to a naturally occurring disease 
outbreak, will be targeted by these law enforcement activities. CDC 
clearly has had, and will continue to have, a responsibility to provide 
technical assistance and advice to the law enforcement community at 
both the federal and the state level. Nevertheless, CDC cannot function 
effectively while administering a primary law enforcement/regulatory 
function that is beyond, and in many respects contrary to, its mission, 
staffing, and expertise.
    Question 2. This year, the National Academy of Science issued a 
report entitled, ``Chemical and Biological Terrorism.'' Their fourth 
recommendation was: ``Improvements in CDC, state and local surveillance 
and epidemiology infrastructure must be undertaken immediately and 
supported on a long term basis.''
    Wouldn't charging CDC with new regulatory and law enforcement 
responsibilities, such as background checks and laboratory inspections, 
be inconsistent with the NAS recommendation?
    Answer 2. As indicated above, additional regulatory 
responsibilities would impede CDC's traditional mission-related tasks 
which are critical to the nations' bioterrorism efforts. In the overall 
context of responding to bioterrorist threats, there are a number of 
areas where further work is needed to develop appropriate safeguards 
against the treats to public health and safety presented by biological 
agents, and toxins. These include effective surveillance and 
epidemiologic investigations, enhanced laboratory capacity, improved 
communication networks, and development of a pharmaceutical stockpile 
of essential drugs and biologics for use in civilian emergencies. These 
activities fall within the traditional purview of CDC, and using FY 99 
resources, CDC is moving aggressively to build capacity in the public 
health community in each priority area. CDC believes regulatory and law 
enforcement responsibilities have the potential to conflict with 
building the public health component of our bioterrorism response 
capacity.
    In December 1998, CDC established the Bioterrorism Preparedness and 
Response Activity (BPRA), to lead an agency-wide effort to prepare for 
and respond to acts of terrorism that involve actual, threatened, or 
suspected uses of biological or chemical agents. BPRA is charged with 
the coordination of CDC's epidemiological and laboratory response 
following a suspected or actual attack and response to health threats 
from unknown biological or chemical agents.
    In February, in an effort to provide support and assistance to 
State and large metropolitan health departments in enhancing their 
ability to be prepared for and respond to a terrorist attack that 
involves a biological or chemical agent, CDC announced the availability 
of nearly $41,000,000 in Public Health Preparedness and Response to 
Bioterrorism cooperative agreement funds. This announcement, along with 
other extramural and intramural strategies, focuses on strengthening 
the public health infrastructure to improve the national capacity to 
address biological and chemical terrorism.
    CDC appreciates the need to craft appropriate restrictions and 
sanctions for improper possession and handling of these select agents. 
However, we believe that any safeguards 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.
    To do so, we need to ensure that current or contemplated 
restrictions and sanctions on possession or handling of biologic agents 
do not have a chilling effect on the availability and willingness of 
scientists and research establishments to take part. Such could well be 
the effect of ill-advised and overbroad provisions of law that, for 
example, place unnecessary restrictions on categories of individuals 
permitted access to biologic agents, or require research laboratories 
to perform law enforcement functions with regard to their employees. In 
the ongoing exploration of this issue, HHS is committed to consulting 
closely with law enforcement agencies and the medical and scientific 
research community to develop safeguards on possession and handling 
without creating disincentives that would impede this critically needed 
research work.
                                 ______
                                 
    Prepared Statement of Alan F. Holmer, President, Pharmaceutical 
                 Research and Manufacturers of America
    Mr. Chairman and Members of the Subcommittee: On behalf of the 
Pharmaceutical Research and Manufacturers of America (PhRMA), I am 
pleased to present recommendations for inclusion in the Subcommittee 
record on the adequacy of federal law relating to biological agents. 
PhRMA represents the country's leading research-based pharmaceutical 
and biotechnology companies, which will invest more than $24 billion 
this year alone in discovering and developing new medicines to help and 
heal patients. PhRMA companies are leading the way in the search for 
new cures and treatments. Currently, there are 136 new medicines in 
development to treat or prevent infectious diseases, humankind's oldest 
and most persistent enemy.\1\
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    \1\ Pharmaceutical Research and Manufacturers of America. New 
Medicines in Development for Infectious Diseases. Washington, D.C. 
1998.
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    PhRMA recognizes that concerns have been expressed about the threat 
of bioterrorism and believes that these concerns should be carefully 
addressed. We will continue to work with the Commerce Committee and the 
Administration to find ways to minimize the threat of misuse of 
biologic agents at home and abroad. However, without diminishing these 
concerns, we caution that natural occurrences of infectious diseases 
are a far greater threat to human life and public health than 
biological agents are. The Center for Disease Control and Prevention's 
(CDC) 1998 document ``Preventing Emerging Infectious Diseases'' \2\ 
reports that, without a strong and vigilant public health system, we 
can expect to see a continued reemergence of infectious diseases. 
Infectious diseases will claim more than 100,000 American lives this 
year and cost more than $30 billion in direct treatment expenses 
alone.\3\
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    \2\ Centers for Disease Control and Prevention. Preventing Emerging 
Infectious Diseases: A Strategy for the 21st Century. Atlanta, Georgia: 
U.S. Department of Health and Human Services, 1998.
    \3\ Pharmaceutical Research and Manufacturers of America. New 
Medicines in Development for Infectious Diseases. Washington, D.C. 
1998.
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    The 136 medicines and vaccines currently being developed by 
America's pharmaceutical companies provide our best hope of reducing 
that toll. Therefore, any regulation or legislation regarding the 
possession and transfer of select biological agents must take great 
care not to obstruct legitimate research that helps patients.
    We believe the CDC regulatory controls on the transfer of select 
biological agents and other infectious agents establish strong and 
sufficient protections against related criminal bioterrorist activity, 
while allowing important research and disease surveillance activities 
to go forward. However, any new legislation or regulation should:

 be carefully drafted so that it is not unduly broad. For 
        example, any new legislation or regulation should not cover 
        biological agents in clinical specimens, or naturally occurring 
        biological agents (e.g., Bacillus anthracis in soil).
 not put undue burdens on the exchange of microbial strains and 
        cultures--including, sample collections which are not fully 
        characterized--among biomedical research scientists. Such 
        burdens may discourage or delay legitimate and important 
        research into ways of combating infectious disease and 
        complicate the operation of surveillance programs (potentially 
        without having a great effect on those intent on illegitimate 
        bioweapons research).
 take into account the legislation and regulation which already 
        exist for the use of infectious agents. For example, agent risk 
        group classifications and procedures for handling certain 
        infectious agents are given in the National Institutes of 
        Health document ``Guidelines for Research Involving Recombinant 
        DNA Molecules'' (61 Fed. Reg. 1481-1490). The use of Human 
        Immunodeficiency Virus (HIV), Hepatitis B Virus and 13 other 
        microorganisms are regulated under ``Occupational Exposure to 
        Bloodborne Pathogens'' (56 Fed. Reg. 64175-64182). CDC, the 
        Department of Agriculture, and the Department of Commerce 
        control the import and export of microorganisms. Airline 
        transportation rules also play a role in ensuring the safety of 
        shipments of biological agents. Thus, multiple regulations are 
        already in place.
    We thank you for the opportunity to submit these comments. PhRMA 
applauds the Committee's efforts to combat terrorism and we look 
forward to working with you on this important issue.
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