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Interstate transportation of human pathogens : hearing before the Committee on the Judiciary, United States Senate, One Hundred Fourth Congress, second session ... March 6, 1996 online

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S. Hrg. 104-834

INTERSTATE TRANSPORTATION OF

"THUMAN PATHOGENS



GOVDOC



Y 4.J89/2:S.Hrg.
I0J4' ^3y



HEARING

BEFORE THE

COMMITTEE ON THE JUDICIARY
UNITED STATES SENATE

ONE HUNDRED FOURTH CONGRESS

SECOND SESSION

ON

EXAMINING ISSUES RELATING TO THE INTERSTATE TRANSPORTATION
OF HUMAN PATHOGENS



MARCH 6, 1996



Serial No. J-104-67



Printed for the use of the Committee on the Judiciary



Vwr'o 8 2000 I I




39-780CC



U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 1997



For sale by the U.S. Government Printing Office

Superintendent of Documents, Congressional Sales Office, Washington, DC 20402

ISBN 0-16-054927-2



I Ci"- v'^ - ^e^



S. Hrg. 104-834

INTERSTATE TRANSPORTATION OF

IHUMAN PATHOGENS



GOVDOC
Y 4.J89/2:S.Hrg.



HEARING

BEFORE THE

COMMITTEE ON THE JUDICIAKY
UNITED STATES SENATE

ONE HUNDRED FOURTH CONGRESS

SECOND SESSION

ON

EXAMINING ISSUES RELATING TO THE INTERSTATE TRANSPORTATION
OF HUMAN PATHOGENS



MARCH 6, 1996



Serial No. J-104-67



Printed for the use of the Committee on the Judiciary



S^f^p^^'"'^"





39-780CC



U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 1997



For sale by the U.S. Government Printing Office

Superintendent of Documents, Congressional Sales Office, Washington, DC 20402

ISBN 0-16-054927-2



I Ci^ V'S-'^Ps



COMMITTEE ON THE JUDICIARY



ORRIN G. HATCH, Utah, Chairman



STROM THURMOND, South CaroUna
ALAN K. SIMPSON, Wyoming
CHARLES E. GRASSLEY, Iowa
ARLEN SPECTER, Pennsylvania
HANK BROWN, Colorado
FRED THOMPSON, Tennessee
JON KYL, Arizona
MIKE DeWINE, Ohio
SPENCER ABRAHAM, Michigan

Mark R. Disler, Chief Counsel

Manus Cooney, Staff Director and Chief Counsel

Cynthia C. Hogan, Minority Chief Counsel

Karen A. Robb, Minority Staff Director



JOSEPH R. BIDEN, Jr., Delaware
EDWARD M. KENNEDY, Massachusetts
PATRICK J. LEAHY, Vermont
HOWELL HEFLIN, Alabama
PAUL SIMON, IlUnois
HERBERT KOHL, Wisconsin
DL\NNE FEINSTEIN, CaUfomia
RUSSELL D. FEINGOLD, Wisconsin



(II)




CONTENTS



STATEMENTS OF COMMITTEE MEMBERS

Page

Hatch, Hon. Orrin G., U.S. Senator from the State of Utah 1

Specter, Hon. Arlen, U.S. Senator from the State of Pennsylvania 42

Kohl, Hon. Herbert, U.S. Senator from the State of Wisconsin 44

CHRONOLOGICAL LIST OF WITNESSES

Hon. Edward J. Markey, Representative in Congress from the State of Massa-
chusetts 3

Hon. Joseph P. Kennedy, Representative in Congress from the State of Mas-
sachusetts 6

Panel consisting of Mark M. Richard, deputy Assistant Attorney General,
Criminal Division, U.S. Department of Justice, Washington, DC; and James
M. Hughes, director, National Center for Infectious Diseases, Centers for
Disease Control and Prevention, Atlanta, GA, accompanied by Stephen
A. Morse, acting associate director for laboratory science, National Center
for Infectious Diseases, Centers for Disease Control and Prevention 10

Panel consisting of David N. SundwaU, president, American Clinical Labora-
tory Association, Washington, DC; Kenneth I. Bems, president, American
Society for Microbiology, and professor and chair of microbiology, Cornell
University Medical College, New York, NY; and L. Barth Reller, trustee
and immediate past chairman, board of trustees, American Type Culture
Collection, and professor of pathology and medicine and director of clinical
microbiology, Duke University Medical Center, Dvu-ham, NC 27

ALPHABETICAL LIST AND MATERIALS SUBMITTED

Bems, Kenneth I.:

Testimony 30

Prepared statement 32

Hatch, Hon. Orrin G.:

Prepared statement of Hon. John R. Kasich, U.S. Representative in Con-
gress from the State of Ohio 2

Hughes, James M.:

Testimony 14

Prepared statement 16

Kennedy, Hon. Joseph P., II:

Testimony 6

Prepared statement 8

Markey, Hon. Edward J.:

Testimony 3

Prepared statement 4

Reller, L. Barth: Testimony 34

Richard, Mark M.:

Testimony 10

Prepared statement 13

Sundwall, David N.:

Testimony 27

Prepared statement 29



(III)



INTERSTATE TRANSPORTATION OF
HUMAN PATHOGENS



WEDNESDAY, MARCH 6, 1996

U.S. Senate,
Committee on the Judiciary,

Washington, DC.
The committee met, pursuant to notice, at 10:08 a.m., in room
SD-226, Dirksen Senate Office Building, Hon. Orrin G. Hatch
(chairman of the committee) presiding.

Also present: Senators Thurmond, Specter, DeWine, and Fein-
stein.

OPENING STATEMENT OF HON. ORRIN G. HATCH,
A U.S. SENATOR FROM THE STATE OF UTAH

The Chairman. I apologize for being just a little bit late. It is
just one of those things that you can't get away from the office.

This morning, the Judiciary Committee will examine concerns
arising from the interstate transportation of human pathogens. It
may surprise the American people to know that very dangerous, in-
deed deadly organisms which cause diseases and death in human
beings are available for purchase across State lines not only by
those with a legitimate use for them, but by anyone else. These or-
ganisms include the agents that cause the bubonic plague, anthrax,
and other diseases. In fact, the Federal Government has more
strict regulations on the interstate transportation of pathogens
causing disease in plants and animals than it has for the interstate
transportation of agents that cause disease in humans.

I favor regulatory reform and a reduction in the Government's
overall regulatory burden on the American people, but that is not
to say, of course, that the Federal Government has no legitimate
role to play. Some of the biological agents we will discuss today
may be usable as weapons of mass destruction by domestic terror-
ists and, of course, access to them should be regulated.

A recent Washington Post story reported that in May 1995, an
individual in Ohio faxed an order for three vials of the agent that
causes the plague from the American Type Culture Collection, the
ATCC, in Maryland. The purchaser's letterhead appeared to be
that of a laboratory. For instance, I might say for those of you who
are not familiar with the bubonic plague, this disease, otherwise
known as the black death, killed one-third of the people in 14th
century Europe.

When the purchaser called ATCC to complain about slow deliv-
ery, the sales representative became concerned about whether the
caller was someone who should have the plague agent. A series of

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telephone calls followed which led police, Ohio public officials, the
FBI, and emergency workers to scour the purchaser's home. In the
home, they found nearly a dozen M-1 rifles, smoke grenades, blast-
ing caps, and white separatist literature. The deadly microorga-
nisms were found in the glove compartment of the purchaser's
automobile still packed as shipped.

The purchaser was prosecuted under the wire and mail fraud
statutes, and even these charges would not have been possible if
the purchaser had not sent a false statement on the letterhead of
a nonexistent laboratory stating that the laboratory assumed re-
sponsibility for the shipment, as the seller had required.

There are Federal regulations both with regard to the manage-
ment of pathogenic agents, such as how they must be packaged and
stored, and on the protection of clinical and research laboratory
workers. The only restrictions on how a person may receive human
pathogens across State lines, however, are imposed by the sellers
of the pathogens themselves. Human pathogenic agents should be
legitimately available to governmental and private clinical and re-
search laboratories to conduct research and support care for sick
patients. These agents should not be available to just anyone who
wants them as they now are.

Now, I want to work with the Federal agencies, those who have
a legitimate need to obtain these pathogens, and my colleagues in
finding a sensible way. Together, we may be able to keep human
pathogens out of the wrong hands. Strategies to decrease the
chances of criminal misuse of human pathogens must take into ac-
count that these agents are purchased, transported, and possessed
by many government agencies, companies, and individuals for le-
gitimate use. But human pathogens are too readily available today,
as the Ohio episode demonstrates, and some action is warranted.

Now, we are going to hear first from Congressman Ed Markey.
We are real happy to have you here, Ed. We appreciate you taking
time to come over to this side of the Capitol and we look forward
to your testimony.

If Joseph Kennedy can arrive, we will have him, and then hope-
fully Congressman John Kasich. If they can't make it, we are going
to have Congressman Markey handle it for all of them. They have
all taken a leading role on this issue in the House, and I might say
that John Kasich wanted to be with us, but cannot, and he has
submitted a statement for the record, and we will accept state-
ments from others as well.

[The prepared statement of Mr. Kasich follows:]

Prepared Statement of Hon. John R. Kasich, a Representative in Congress
FROM THE State of Ohio

Thank you very much for this opportunity to testify on an issue about which I
feel very strongly. This country has serious gaps in its legal safeguards against the
misuse or terrorist employment of biological warfare agents. In Congressional testi-
mony after the Persian Gulf War, former Chairman of the Joint Chiefs of Staff Colin
Powell stated, "* * * of all the various weapons of mass destruction, biological
weapons are of the greatest concern to me." He had good reason to be concerned.

According to an unclassified CIA study, biological agents are inherently more toxic
than chemical nerve agents on a weight-for-weight basis. Moreover, they are poten-
tially more effective because most are natursdly occurring pathogens, and are self
replicating — which means they could be spread far beyond the attack site by con-
tagion. The CIA further says that there are no reliable biological warfare detection
devices currently available. The principal deterrent to their use in organized war-



fare has been uncertainty about their ultimate consequences, including the risk of
accidentally exposing friendly forces. But that kind of deterrent is of course far less
likely to be a consideration for a terrorist group. We simply have to assume that
the more horrible and cruel the weapon, the greater the attractiveness to a certain
type of deranged mentality.

The difficulty in regiilating biological agents is hard to underestimate. There is
very little that would distinguish a vaccine plant from a biological weapons produc-
tion facility. For example, known biological warfare threat agents include the orga-
nisms that cause anthrax, botulism, and plague; yet there is also extensive legiti-
mate research that requires the production of these agents, for instance, for vaccine
production. That is why it is crucial that we carefully regulate the legitimate sci-
entific use of these materials as the first "firewall" against misuse. The second "fire-
wall" is to increase the punishment provided by law for the unauthorized use of
these agents, for instance, the obtaining of biological agents under false pretenses.
I think everyone in this room would agree that anyone who obtains plague or an-
thrax or botulin cultures through deception ought to be subject to stiffer penalties
than simple mail fraud. Yet, incredibly, that is the case today, and it is one of the
reasons I am so concerned about this subject.

In Lancaster, Ohio, not far from my congressional district, an unauthorized per-
son, Larry Wayne Harris, obtained a sample of bubonic plague culture by simply
writing to the American Type Culture Collection on a phony letterhead. It was prob-
ably onlv because the sample was delayed in the mail that law enforcement became
aware that an unauthorized person had compromised the security of the system.
The delay caused Harris to call the institute and ask why the culture he ordered
hadn't arrived. Only then did an institute employee become suspicious that Harris
was not a qualified recipient, and called the police. Law enforcement authorities
found the bubonic plague samples in the glove compartment of Harris's car.

It so happens that Harris was a member of Aryan Nation. But what he did was
no crime, beyond the issue of wire fraud and mail fraud. Edmund Sargus, the U.S.
Attorney for the Southern District of Ohio, said that the law currently treats the
improper disposal of motor oil by a service station more severely than what Harris
dicf.

That is why I believe it is absolutely necessary to close the legal loopholes that
have allowed biological agents to be treated so leniently. We cannot tolerate even
one case in which biological weapons are used. Last year's tragedy of the Japanese
"Doomsday Cult," which used a weapon of mass destruction (sarin nerve gas) in the
Tokyo subway, shows that a previously unknown group can cause massive casual-
ties. I understand that none of our intelligence agencies had any information on the
group. We simplv cannot rely solely on an intelligence warning to prevent future
incidents in the United States. It is vital that we begin to change the law to reflect
the new reality of weapons of mass destruction in the hands of terrorists. I am de-
lighted to work with my colleagues, Ed Markey and Joe Kennedy, on a bipartisan
basis and begin to solve its problem. Thank you.

The Chairman. We will then have a panel from the Justice De-
partment and the Centers for Disease Control and Prevention. Our
last panel will include Dr. David Sundwall, of the American Clini-
cal Laboratory Association; Dr. Kenneth Berns, who is the presi-
dent of the American College of Microbiology; and Dr. Barth Reller,
representing the American Type Culture Collection. So we welcome
you all here this morning.

We will begin with you, Representative Markey. Thanks for com-
ing. We appreciate your being here and we look forward to your
testimony.

STATEMENT OF HON. EDWARD J. MARKEY, A REPRESENTA-
TIVE IN CONGRESS FROM THE STATE OF MASSACHUSETTS

Representative Markey. Thank you, Senator, very much, and I
very much appreciate the invitation to testify before you this morn-
ing. Congressmen Kennedy and Kasich and I are introducing com-
plementary legislation, one dealing with the criminalization of the
transfer and use of these materials, the other ensuring that the
CDC does go into a rulemaking that will ensure that we have per-



manent controls placed upon the management and reuse of any of
these materials.

You know, in 1900, the average male and female in the United
States died at age 48; that is, we had gone all the way from the
Garden of Eden to 1900 and the life expectancy of the average male
and female was still 48 years of age. Today, the life expectancy is
79 years of age. In other words, we have added 31 years to the life
expectancy of human beings in only this century, and we extended
this across the entire planet as an ethic.

Now, why is that the case? Well, there are a lot of reasons, but
at the heart of it was the research which was done, much of it —
most of it, in fact, sponsored by the Federal Government, to isolate
the infectious diseases that had rumbled through societies, coun-
tries, families, for centuries on end. The isolation and eradication
or limitation of these diseases is to a very large extent the story
of the 20th century.

We do still have diseases which we have not, in fact, cured or iso-
lated. Amongst those are the Ebola and others which you have
mentioned, Mr. Chairman. Those diseases in the wrong hands
would have the potential of wrecking havoc at a level that we have
not seen in our country in a very long time. That white suprema-
cist from Ohio, Larry Wayne Harris, last year who gained access
to very potentially dangerous, infectious substance, and the Aum
group in Japan, an Armageddon group which gained access to sarin
gas, which they were able to use to terrorize the whole city of
Tokyo, are good examples of what happens.

I think we are all surprised that better controls haven't been
placed upon the transfer of the materials which are kept and iso-
lated. The fact that there are not formalized controls, I think, is a
shock to all of us. Now, I know that the CDC, the Justice Depart-
ment, and HHS have been working now on this issue since last
summer, but I do believe quite firmly that we should just pass a
law to ensure that, permanently, there will be a control regime
which is placed over these materials. Notwithstanding the good
work which the CDC is doing right now, I think it is absolutely
critical for us to pass that legislation.

So I thank you for the invitation to testify here today. I think
it is something that we should all be very concerned about. In the
wrong hands, it could cause devastating consequences for large por-
tions of our population.

Thank you, Mr. Chairman.

The Chairman. Thank you. Congressman Markey. You have set
the stage really well and I appreciate it. One of your constituents
up there in Boston, Robin Cook, just wrote this bestseller, called
"Contagion," which points this out in a very practical way. I think
it is the kind of a book that everybody ought to read because al-
though his books are fiction, they really are more truth than fiction
in a very real sense with regard to some of these matters, and es-
pecially in this case of human pathogens.

[The prepared statement of Mr. Markey follows:]

Prepared Statement of Representative Edward J. Markey

Mr. Chairman, I want to commend you on calling this morning's hearing. Surely,
the importance of keeping infectious agents that could pose a serious threat to the



public's health and safety out of the hands of dangerous people is something we can
all agree on, even in these often partisan times.

We all know the story of Larry Wajoie Harris, the Ohio white supremacist who
ordered bubonic plague through the mail last summer. It's frightening to think that
just about anybody with a 32 cent stamp and a little chutzpah could get a hold of
any number of potentially dangerous infectious substances. The Ohio case may be
an isolated incicient or it may not be — we really don't know. Why? Because the fed-
eral government has no system in place today to regulate the transfer of these
agents within the United States. I think that's a situation that needs to be cor-
rected, and I am introducing legislation today to do so.

Why worry about the flow of potentially dangerous infectious agents within our
borders? Let me read you a few lines from an article on the threat posed by these
agents when they are converted into biological weapons, written by LJ.S. Navy Com-
mander Stephen Rose for the Naval War College Review. Cmdr. Rose writes that:

Science can now reshuffle the genetic deck of micro-organisms to produce
a theoretically unlimited number of combinations, each with its own unique
blend of toxicity, hardiness, incubation period, etc. In short, it is becoming
possible to synthesize biological agents to military specifications. Thus, the
world lies on the threshold of a dangerous era of designer bugs as well as
designer drugs.

Biological weapons have been called the "poor man's atomic bomb." They are rel-
atively cheap to produce, and you get an appallingly big "bang for vour buck." In
fact, experts report that some of the supertoxins that have been developed in recent
years are ten thousand times more potent than the nerve gases we are more accus-
tomed to, which have been described as "mere perfiime" in comparison to some of
their biological competitors. The Office of Technology Assessment reports that some
15 nations, including Libya, North Korea, and Iraq, are suspected of having biologi-
cal weapons development programs.

Clearly, the potential of biological weapons to rain devastation down upon their
victims should give those charged with preventing international terrorist attacks on
ovir nation cause for serious concern. However, the lesson we learned from the trag-
edy at Oklahoma City is that we cannot be satisfied to only look outward for terror-
ist threats. We must also be vigilant against "home-grown" threats from para-
military groups within our borders, which could use biological weapons against their
fellow Americans to further their anti-government agendas.

On the morning of March 20, 1995, the Japanese government was faced with just
such a situation. A "home-grown" Armageddon-group called Aum Shinrikyo released
sarin gas — a deadly nerve agent that is 500 times more toxic than cyanide gas —
in the Tokyo subway system, killing twelve people and injuring thousands more. Ac-
cording to a staff report on the incident prepared by the Senate Permanent Sub-
committee on Investigations, the Aum sect had its own chemical weapons manufac-
turing plant (for the production of sarin gas) and was trying to develop biological
weapons, including botulism and anthrax. To get a sense of power of those weapons,
consider this: 3 billionths of an ounce of botulism toxin would be enough to kill me.

Incidentally, the staff report concluded that the Aum sect was "a clear danger to
not onlv the Japanese government but also to the security interests of the United
States,' which was the target of much of the Aum leader's rhetoric.

In an effort to reduce the risk of a similar attack in the United States, I have
introduced legislation directing the Centers for Disease Control to develop a regu-
latory regime to control access to those infectious agents that could pose the great-
est threat to public health if they fell into the wrong hands. It is my understanding
that a working group including representatives of CDC, the Department of Justice,
and other relevant federal agencies already has begun to develop such a regime. My
bill would ensure that that work is completed and the system is in place within one
year of its enactment.

I am hopeful that this legislation will be given the swift attention that the issue
it addresses demands in the House, and that the Senate will take up similar legisla-
tion soon. I also hope the administration will respond promptly to the request that
I recently made with Senator Specter and a number of other House and Senate
members for the transfer of approximately $7 million from the Defense Department
to the Office of Emergency Preparedness at the Department of Heedth and Human
Services. This transfer would ensure that the office, which has been charged with
coordinating emergency response in the event that a biological weapon is ever used
on American soil, has the necessary resources to accomplish this critical mission.
The administration requested additional funds for this office from the Appropria-
tions Committees last July, but that request was not approved. It is my understand-



ing that, under this approach, additional funds could be provided for OEP without
further congressional action.

Thank you, again, for holding today's hearing and allowing me to participate in
it.

The Chairman. Joe Kennedy, we are happy to welcome you here.
We are glad to have you on our side of the Capitol and look for-
ward to taking your testimony at this time.

STATEMENT OF HON. JOSEPH P. KENNEDY, II, A REPRESENTA-
TIVE IN CONGRESS FROM THE STATE OF MASSACHUSETTS

Representative Kennedy. Thank you very much, Mr. Chairman.
I, first of all, want to thank you very much for the keen interest
and awareness that you have shown on this issue. Obviously, I
think your State perhaps more than any other in the country has
had experiences in its history with chemical and biological agents
that have caused harm and destruction, and probably has an acute
awareness of the downside of some of the unbelievable toxins that
have been both created by man and created by God and the de-
structive nature that can be utilized if they fall into the wrong
hands.

So I appreciate your willingness and the other members' willing-
ness to delve into this issue, and I think it is an issue that, as I
am sure my friend, Ed Markey, has indicated, requires, I think, a
couple of different approaches if we are going to be successful in
dealing with the harm that potentially can affect the American peo-
ple.

I actually think that the approach that Mr. Markey is taking, to
begin with, makes a great deal of sense. It is my feeling that at
a certain point the Government does have to protect its citizens,
and there are times when that is going to require additional regu-
lation and fact that we do not currently have regulations and rules
about who can go out and actually create these unbelievable toxins
is absolutely astounding.

We regulate and tell people that they can't go out and build a


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Online LibraryUnited States. Congress. Senate. Committee on theInterstate transportation of human pathogens : hearing before the Committee on the Judiciary, United States Senate, One Hundred Fourth Congress, second session ... March 6, 1996 → online text (page 1 of 7)