[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
------------------------------------------------------------------------------
For sale by the U.S. Government Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402
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
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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.