[Senate Hearing 107-665]
[From the U.S. Government Publishing Office]
S. Hrg. 107-665
REMEDIATION OF BIOLOGICALLY AND
CHEMICALLY CONTAMINATED BUILDINGS
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON
ENVIRONMENT AND PUBLIC WORKS
UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
ON
REVIEW OF CLEANUP ACTIVITIES IN FEDERAL BUILDINGS AFFECTED BY ANTHRAX
CONTAMINATION
__________
DECEMBER 4, 2001
__________
Printed for the use of the Committee on Environment and Public Works
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COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS
one hundred seventh congress
first session
JAMES M. JEFFORDS, Vermont, Chairman
MAX BAUCUS, Montana BOB SMITH, New Hampshire
HARRY REID, Nevada JOHN W. WARNER, Virginia
BOB GRAHAM, Florida JAMES M. INHOFE, Oklahoma
JOSEPH I. LIEBERMAN, Connecticut CHRISTOPHER S. BOND, Missouri
BARBARA BOXER, California GEORGE V. VOINOVICH, Ohio
RON WYDEN, Oregon MICHAEL D. CRAPO, Idaho
THOMAS R. CARPER, Delaware LINCOLN CHAFEE, Rhode Island
HILLARY RODHAM CLINTON, New York ARLEN SPECTER, Pennsylvania
JON S. CORZINE, New Jersey BEN NIGHTHORSE CAMPBELL, Colorado
Ken Connolly, Majority Staff Director
Dave Conover, Minority Staff Director
C O N T E N T S
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DECEMBER 4, 2001
OPENING STATEMENTS
Page
Carper, Hon. Thomas R., U.S. Senator from the State of Delaware.. 4
Clinton, Hon. Hillary Rodham, U.S. Senator from the State of New
York........................................................... 15
Corzine, Hon. Jon S., U.S. Senator from the State of New Jersey.. 11
Inhofe, Hon. James M., U.S. Senator from the State of Oklahoma... 4
Jeffords, Hon. James M., U.S. Senator from the State of Vermont.. 1
Smith, Hon. Bob, U.S. Senator from the State of New Hampshire.... 2
Voinovich, Hon. George V., U.S. Senator from the State of Ohio...13, 18
WITNESSES
Grosser, Mike, technical director, Nuclear Biologic and Chemical
Defense Systems, Marine Corps Systems Command.................. 26
Prepared statement........................................... 52
Meehan, Patrick, M.D., Director, Division of Emergency and
Environmental Health Services, National Center for
Environmental Health, Centers for Disease Control and
Prevention, Department of Health and Human Services............ 21
Prepared statement........................................... 46
Responses to additional questions from:
Senator Corzine.......................................... 49
Senator Jeffords......................................... 48
Senator Smith............................................ 49
Vinney, Les, president and CEO, STERIS Corporation accompanied
by: Peter Burke, vice president and chief technology officer;
Gerry Reis, vice president for Corporate Administration; Karla
Perri, senior environmental consultant, Versar, Inc............ 28
Comments on the Proposed Remediation Plan for the Hart Senate
Building (HSOB)............................................ 64
Comparison of Antimicrobial Foam, Liquid Chlorine Dioxide and
Registered Sporicidal Products............................. 67
Comparison of Antimicrobial Fogging, Chlorine Dioxide and VHP
for Room Decontamination................................... 66
Comparison of Bleach and Registered Sporicidal Products for
Liquid Surface Disinfection................................ 67
Comparison of Room Decontamination Methods................... 68
Detailed Biological Remediation Plan......................... 58
Features of Current Proposal and Proposed Alternatives....... 67
Overview..................................................... 57
Prepared statement........................................... 55
Responses to additional questions from:
Senator Jeffords......................................... 62
Senator Smith............................................ 63
Walks, Ivan, M.D., director, District of Columbia Department of
Health......................................................... 23
Prepared statement........................................... 51
Whitman, Hon. Christine Todd, Administrator, Environmental
Protection Agency.............................................. 5
Prepared statement........................................... 34
Responses to additional questions from:
Senator Corzine.......................................... 39
Senator Jeffords......................................... 37
Senator Smith............................................ 40
ADDITIONAL MATERIAL
Comments on the Proposed Remediation Plan for the Hart Senate
Building (HSOB)................................................ 64
Comparison of Antimicrobial Foam, Liquid Chlorine Dioxide and
Registered Sporicidal Products................................. 67
Comparison of Antimicrobial Fogging, Chlorine Dioxide and VHP for
Room Decontamination........................................... 66
Comparison of Bleach and Registered Sporicidal Products for
Liquid Surface Disinfection.................................... 67
Comparison of Room Decontamination Methods....................... 68
Detailed Biological Remediation Plan............................. 58
Features of Current Proposal and Proposed Alternatives........... 67
Letter, Battelle Memorial Institute.............................. 69
Summary, Decontamination Methods--Bacterial Spores, Battelle
Memorial Institute............................................. 70
Tables, Remediation plans for Federal Buildings.................. 66-69
REMEDIATION OF BIOLOGICALLY AND CHEMICALLY CONTAMINATED BUILDINGS
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TUESDAY, DECEMBER 4, 2001
U.S. Senate,
Committee on Environment and Public Works,
Washington, DC.
The committee met, pursuant to notice, at 9:30 a.m. in room
406, Senate Dirksen Building, Hon. James M. Jeffords (chairman
of the committee) presiding.
Present: Senators Jeffords, Smith, Carper, Voinovich,
Corzine, and Clinton.
OPENING STATEMENT OF HON. JAMES M. JEFFORDS, U.S. SENATOR FROM
THE STATE OF VERMONT
Senator Jeffords. The hearing will come to order.
I'd like to begin by thanking all of our witnesses for
participating in today's hearing on building decontamination.
Last week, several congressional committees held hearings
on various aspects of our experience with bioterrorism.
Concerns were raised about the ability to quickly and
efficiently respond with appropriate assessment and
decontamination protocols. A resonating conclusion was a need
for more consistent information and more centralized
leadership. One position stated that we have been operating in
an informational vacuum. I agreed and that is why we are here
today. Sadly, terrorism has become a fact of life and although
our law enforcement officials are working diligently to ensure
our safety, we must take every measure to guarantee our
preparedness. That means that we need to learn quickly from our
current difficulties.
We are here today seeking knowledge in three areas: first,
the coordination that goes into decontaminating a building;
second, the health aspects of both cleanup technologies and
residual contaminants; and finally, the various technologies
available for remediating a building.
I believe that this hearing is critical as a forum in which
we can all learn. After all, we are the test case and photos
you will see here today document a historical event. Affected
parties such as the U.S. Postal Service are awaiting a
decontamination model to emerge out of EPA's current efforts to
remediate the Hart Senate Office Building. No prior attempt has
ever been made to remediate a biologically contaminated
building. In fact, 2\1/2\ years ago, the Working Group on
Civilian Biodefense published a report which stated that such a
decontamination effort would be extremely difficult. Well,
leave it to Congress to expect to rewrite the science. Here we
are.
EPA has been given a tremendous responsibility despite the
lack of prior experience and systematic protocol. Therefore, I
am pleased that we have Governor Christine Todd Whitman with
us, the EPA Administrator, and I would like to thank her for
her current efforts and offer my assistance as we both learn
about the response protocol necessary to effectively address
acts of bioterrorism.
I turn to my compatriot here.
The prepared statement of Senator Jefford follows:]
Statement of Hon. James M. Jeffords, U.S. Senator from the State of
Vermont
I'd like to begin by thanking all our witnesses for participating
in today's hearing on Building Decontamination.
Last week, several congressional committees held hearings on
various aspects of our recent experience with bioterrorism. Concerns
were raised about our ability to quickly and efficiently respond with
appropriate assessment and decontamination protocols. A resonating
conclusion was the need for more consistent information and more
centralized leadership. One physician stated that we have been
operating in an ``informational vacuum.'' I agree and that is why we
are here today.
Sadly, terrorism has become a fact of life. And although our law
enforcement officials are working diligently to ensure our safety, we
must take every measure to guarantee our preparedness. That means that
we need to learn quickly from our current difficulties.
We are here today seeking knowledge in three areas. First, the
coordination that goes into decontaminating a building. Second, the
health effects of both cleanup technologies and residual contaminants.
And finally, the various technologies available for remediating a
building.
I believe that this hearing is critical as a forum in which we can
all learn. After all, we are the test case, and the photos you see here
today document an historical effort. Affected parties, such as the U.S.
Postal Service, are awaiting a decontamination model to emerge out of
EPA's current efforts to remediate the Hart Senate Office Building.
No prior attempt has ever been made to remediate a biologically
contaminated building. In fact, 2\1/2\ years ago, the Working Group on
Civilian Biodefense published a report which stated that such a
decontamination effort would be extremely difficult. Well, leave it to
Congress to expect to re-write science. EPA has been given a tremendous
responsibility despite the lack of prior experience and systematic
protocol.
Therefore, I am pleased that we have Governor Christine Todd
Whitman, the EPA Administrator, with us today. I would like to thank
her for her current efforts, and offer my assistance as we both learn
about the response protocol necessary to effectively address acts of
bioterrorism.
OPENING STATEMENT OF HON. BOB SMITH, U.S. SENATOR FROM THE
STATE OF NEW HAMPSHIRE
Senator Smith. Thank you, Mr. Chairman.
Good morning, Governor.
I wanted to make just a brief comment that Senator Inhofe
has asked me to make but I share Senator Inhofe's concern
because it seems every time there is an important Armed
Services Committee meeting, there is an important EPW Committee
meeting and many of us are on both of those committees. I know
on at least four occasions Senator Inhofe has raised that
point. There are four members who are on both committees.
Again, Senator Inhofe asked me to raise it that we ought to try
to have a little more coordination. I realize that is a two-way
street but it really is a problem. I know there are some very
important nominations that are taking place right now in the
Armed Services Committee which means I am going to have to
leave at some point before I wanted. I hope we can at least try
to work to coordinate that a little better.
Senator Jeffords. We certainly will. We are not trying to
be uncoordinated.
Senator Smith. No, there is a chairman over there too. It
takes two to coordinate. I understand.
Thank you for holding this hearing and Governor, it's good
to see you again. You certainly had a baptism under fire with
what has been going on. The anthrax matter has obviously been
of grave concern to all of us. We are looking forward to
hearing your remarks.
I have a prepared statement that I will enter for the
record.
[The prepared statement of Senator Smith follows:]
Statement of Bob Smith, U.S. Senator from the State of New Hampshire
Mr. Chairman, thank you for holding this hearing. Welcome to
Governor Whitman--it is always good to see you before this committee. I
also want to welcome all of the witnesses who are here today.
There is no question that these are difficult times. Beginning on
September 11, this Nation has faced many of its worst nightmares--the
attacks on the Pentagon and World Trade Center. And that was soon
followed by the quiet horror of biological attacks.
Since September 18, several letters containing anthrax have
terrorized this nation.
It has been devastating to our postal employees--and our Nation
sends our deepest sympathies to those brave public servants who
continue to do their duty in these very difficult times.
Those who are the innocent victims of this terror cover the
spectrum, from a 7-month-old little boy, who was diagnosed with
cutaneous anthrax--to a 94-year-old woman, who just recently died. We
send our deepest condolences to families and friends of the victims of
these cowardly attacks.
Of course, we here in the Senate, have also felt the sting of
anthrax. Letters containing anthrax sent to the Senate have left many
up here quite shaken. Most of us have been tested for anthrax exposure
and many continue to take CIPRO as a precaution.
Twenty-eight Senate employees have tested positive for exposure,
but fortunately, no infections.
While it has been a difficult time, we have been lucky that the
difficulties have, thus far, only been inconveniences. These attacks
have also left us with the dilemma of how to remediate the
contamination of the numerous affected buildings.
There is an uneasiness with many who were in these buildings when
the anthrax arrived and who will be going back into them when the
cleanup is completed. We are all more than a little uneasy when dealing
with so many unknowns--and I do not envy you, Governor Whitman, or
anyone else involved in the testing and cleanup.
The Nation has many questions, concerns and fears--and the answers
are not easy. It is certainly a daunting task. It is my hope that
today, you and the other witnesses, will take this opportunity to
address many of the questions that we all have.
There is much that has been done over the past few days and we are
all certainly anxious to hear how the remedial activity of the Hart
Senate Office Building went over the weekend. Hart is undoubtedly the
testing ground for other anthrax cleanups, so it is important that the
work is done in a deliberate manner. I hope that has been the case.
Governor, I do want to take this moment to thank you, Marianne
Horinko and all of those at the Environmental Protection Agency for
their tireless work since the events of September 11. It has been a new
world for your Agency--an unquestionable challenge--and I commend you
and the entire agency for your efforts.
Thank you all again for coming here today and I look forward to
your testimony.
Senator Smith. I ask unanimous consent to enter the opening
statement of Senator Inhofe in the record as well.
Senator Carper. Reserving the right to object.
[Laughter.]
[The prepared statement of Senator Inhofe follows:]
Statement of James M. Inhofe, U.S. Senator from the State of Oklahoma
Mr. Chairman, thank you for holding this very important hearing. I,
too, am very interested in hearing from Administrator Whitman on the
challenges of, and technologies available for, remediating buildings
contaminated by biological contaminants.
Specifically, I am interested in hearing from the Administrator on
the following issues:
(1) Enhanced detection systems for chemical and biological agents;
and
(2) EPA's compliance with all of their regulations during the
remediation process.
0klahoma is no stranger to terrorism. Until September 11th,
Oklahoma had the unfortunate distinction of having been the victim of
the worst terrorist act. As a result, what we as a Nation are doing
right now; Oklahoma has been doing for a few years now. That is looking
at how do we prevent and mitigate terrorist acts.
Since September 23, 1999, under the direction of former Army
General and Chief of Staff Dennis Reimer, the Oklahoma City National
Memorial Institute for the Prevention of Terrorism (MIPT) has been
dedicated to preventing and reducing terrorism and mitigating its
effects by conducting not only research into the social and political
causes and effects of terrorism and but also the development of
technologies to counter biological, nuclear and chemical weapons of
mass destruction as well as cyber terrorism.
Originally incorporated as a non-profit corporation in Oklahoma and
recognized as a charitable organization by the Internal Revenue
Service, MIPT grew out of the desire of the survivors and families of
the Murrah Federal Building bombing of April 19, 1995 to have a living
memorial. As Oklahomans, we intend to honor that desire by doing what
we can to try to prevent other cities from living through what Oklahoma
City had to live through--and what New York and Virginia are living
through now.
MIPT has a special obligation to first responders--police officers,
firefighters, emergency medical technicians and all of the others who
are first on the scene in the aftermath of terrorist activity.
Therefore, they also sponsor research to discover equipment, training
and procedures that might assist them in preventing terrorism and
responding to it. While MIPT has a special obligation to first
responders, they are prepared to engage in any activities that will
help them fulfill our mandate.
For example, unfortunately, today's anthrax vaccine is not
appropriate for protecting the general public, so there is a critical
need to develop new therapies that could be quickly administered
following a bioterrorist attack. Therefore, just recently, MIPT and the
Oklahoma University Health Sciences Center started a 3-year, $2.48
million research effort to develop new drugs which will lessen the
threat from anthrax. Specifically, this research seeks to develop new
medications that block the lethal toxins produced by anthrax bacteria.
These medications could be much more effective than the current vaccine
since they would target toxin activity after the initial anthrax
infection.
With this tool that may counter anthrax more effectively than the
current vaccine, the United States may be better positioned to deter
terrorists from considering this type of weapon in the future.
This project is one of 10 counterterrorism projects that MIPT is
currently pursuing. Other projects include better protective clothing
for those working in hazardous environments, enhanced detection systems
for chemical and biological agents, a study of communications
surrounding terrorist episodes, a study of the psychological impact of
terrorism, defense of communications systems, and data bases on
terrorism and counterterrorism equipment.
MIPT currently funds projects all over the country, including
California, Florida, Missouri, Rhode Island, and Virginia. MIPT has
also received over 250 proposals for its next round of research
projects. A decision on which of these projects to fund will be made in
the course of the next 90 days. As we move forward with preventing and
mitigating terrorism, I would urge my colleagues to work with MIPT.
Perhaps, the testimony, which we hear today, can help provide some
ideas to further MIPT's critical work.
OPENING STATEMENT OF HON. THOMAS R. CARPER, U.S. SENATOR FROM
THE STATE OF DELAWARE
Senator Carper. I will not object if the chairman would let
me make a short statement.
Governor, welcome.
I am one of nine Democrats on this committee whose offices
are in the Hart Building. We have been without an office for
about 1\1/2\ months. But for the grace and hospitality of
Senator Biden--his staff, we would be out on a truck loading
dock somewhere. As it turns out, he has been good enough to
share his conference room with us. It is tight quarters but at
least they are quarters and we are grateful for that kindness.
It has given us a close knitness as a congressional delegation,
a Senate delegation, as you might imagine, all being huddled
there together.
I am sort of torn on the issue of Hart. On the one hand, we
want to get back, not desperately but expeditiously, into our
quarters to be able to do our jobs better. By the same token,
we want to make sure we are all safe. It is a tough balancing
act and we are real grateful for your help and that of your
agency, first of all, to make sure when we do go back, we are
safe and second, we can get back in there as quickly as
advisable.
That being said, Mr. Chairman, I yield my time. I am going
to go preside at 10 o'clock and won't be able to stay for part
of this hearing but I look forward to your testimony, Governor.
Welcome.
Senator Jeffords. Thank you.
Please proceed.
STATEMENT OF HON. CHRISTINE TODD WHITMAN, ADMINISTRATOR,
ENVIRONMENTAL PROTECTION AGENCY
Administrator Whitman. Thank you very much, and with your
permission, I have a longer statement that I would like to
submit for the record.
Senator Jeffords. It will be.
Administrator Whitman. Thank you.
Since the events of September 11, the Environmental
Protection Agency has seen its longstanding mission to protect
human health and the environment take on new meaning and a
renewed sense of urgency. Since the discovery of anthrax in
various public and private buildings, EPA has been operating
under the authority or response structure that we have long
used in addressing Superfund contaminations which gives us a
responsibility for cleaning up contaminated sites to protect
human health and the environment. The manner in which we have
proceeded also follows the general provisions of the
Presidential Decision Directive No. 62 signed by President
Clinton in 1998. That PDD gives the Environmental Protection
Agency responsibility for cleaning up buildings and other sites
contaminated by chemical or biological agents as a result of a
terrorist act. Nevertheless, as we have moved forward to
address our responsibilities in the anthrax contamination, we
have found the structures and responsibilities outlined under
PDD No. 62 have not been as clearly articulated as we would
like because everyone involved has been focused on getting
results and we have not allowed the discussion of a process to
halt the progress. Even though it seems like a long time, that
has not been the case. The lack of specific clarity in the 1998
Presidential Decision Directive has made things more
complicated at times than they needed to have been.
I raise this issue not to be critical in any way but rather
to highlight the fact that plans put on paper almost always
have to be adjusted to the realities of events and that is why
we are working very closely with Governor Ridge and the Office
of Homeland Security to bring greater clarity to the roles of
the various Federal departments and agencies they should play
in responding to biological attacks and how we should best
relate to our State and local partners.
In responding to the current biological attacks, EPA's role
at the site generally began after the Center for Disease
Control and Prevention determined the presence of a biological
contaminant that posed an unacceptable risk to human health. We
have also worked with CDC to advise the incident commanders
about the extent to which the building must be cleaned to make
it safe. Then once a building has been decontaminated, the
incident commander has responsibility for determining whether a
building is safe for reoccupancy.
The sites themselves are under the control of the incident
commander. Usually someone from the local response team, the
EPA, CDC and the other Federal agencies work with that incident
commander providing expertise and advice and performing such
work as testing and cleanup at times.
With respect to the cleanup of those places found to be
contaminated by anthrax, several different approaches have been
taken. The Postal Service, for example, has hired a qualified
contractor to perform cleanup at their facilities, as did
several media organizations. In those cases, the Environmental
Protection Agency provided technical assistance to those
actually doing the cleanup work.
Here on Capitol Hill, we have been asked by the Senate
Sergeant at Arms, who is serving as your incident commander, to
undertake the cleanup of the Hart Senate Office Building, just
as we were asked by the Clerk of the House to clean up the
contaminated locations on the House side.
As you know, the cleanup of the Hart Building poses by far
the largest and most extensive cleanup challenge of anthrax
ever undertaken in a building. To meet this unprecedented
situation, our cleanup experts have been drawing on their years
of experience and expertise, on the talents of scientists and
industry and academia and the knowledge available from our
other Federal partners to devise the right plan for the Hart
Building. This expertise and experience has served us well to
date, leading to the successful cleanup of many post offices
and other buildings and this past weekend to the fumigation of
parts of the Hart Building. As our knowledge increases, our
ability to successfully address anthrax contamination will
continue to improve. We are quite literally writing the book as
we go along. I am proud of the work the agency has done in
identifying methods to clean up anthrax in situations never
before envisioned by planners or prognosticators.
It is not an exaggeration to say that EPA and our partners
have done more in the past 6 weeks to advance the knowledge
about the science and technology of anthrax detection and
cleanup than in the previous six decades. As we seek to apply
the lessons we are learning from all the decontamination
efforts from the simplest to the most complex, one thing has
become very clear and that is that one-size-does-not-fit-all
when we are facing this kind of challenge. Each event has to be
thoroughly analyzed as a separate case before we can propose an
effective solution.
For example, cleaning a facility that contains rugged heavy
equipment can be accomplished generally using foams or liquids,
methods the contents of that building can stand up to. A
building that contains a lot of paper, office furniture,
electronic equipment, that must be cleaned up using a different
method so as not to damage those things the way a liquid or a
foam would damage them.
Other factors such as the amount of contamination found,
the ways and the extent to which it can be dispersed through
the building, the nature of the surrounding areas and the ways
in which a building is used all require different
considerations before proceeding with decontamination. That is
why it has required more time to address the Hart Building than
any of us would have liked. This has been a highly complex
challenge but we believe the time we have taken has been well
spent because we have taken the time to do it right and we have
advanced our knowledge in the best way to undertake these
efforts.
While we are all hopeful we are never going to have to use
this knowledge again, we have to proceed as if we might. That
is why there are two specific things I would like to ask the
committee to consider for the future. The first concerns
indemnifying the contractors EPA hires to perform the actual
cleanup. We spent a great deal of time in recent days leading
up to the fumigation in the Hart Building last weekend to
provide the contractors we were hiring to perform that
decontamination with sufficient protection and liability should
something unexpected occur during the cleanup. After a lot of
work, we were able to get the issue sorted out but it took much
more time than it should have.
EPA's current indemnification authority under CERCLA is not
adequate to meet the needs resulting from acts of terrorism.
That is why it would be helpful if for the future, EPA's
indemnification authority could be extended to meet the
response to domestic acts of terrorism.
The second issue where I would like to ask for your help
concerns our ability to recover costs resulting from cleanup.
Currently, EPA can recover costs when performing the cleanup of
hazardous substance. The authority, however, does not extend to
biological agents or various other pollutants that could be
used in a terrorist attack. Giving EPA the ability to recover
costs in those instances would just remove one more issue that
slows us down a little bit, would allow us to focus a little
more quickly in getting things operating faster.
I should point out that this has not been an issue with the
Hart Building. The Senate has agreed to pay from the beginning
and we are very thankful for that and appreciate that.
I would be happy to take any questions you might have on
any of these issues.
Senator Jeffords. Thank you. We are all sitting here
interested in this. My office is in the Hart Building. Yours is
too?
Senator Smith. No, mine isn't. It is in Dirksen, I am
pleased to say.
Senator Jeffords. How did EPA identify chlorine dioxide as
the best remediation technology?
Administrator Whitman. What we did is we were in close
contact with the CDC, with the military, we talked to the
private sector and we had a trailer set up at the Brentwood
facility where we used the different methods of
decontamination. First, understand there was no licensed
product to decontaminate anthrax in a building. We have had to
issue some emergency clearances to allow us to use the chlorine
dioxide liquid and the envirofoam that are the two agents you
put on hand application and then the chloride dioxide fumigant,
the spray.
We looked at what would have the greatest impact, what
actually resulted in killing of the spores in the DNA and the
spores and the collateral damage that would be done to the
rooms that were being decontaminated or anything that might be
in those rooms. Based on that, we put together a proposal we
submitted to the incident commander with recommendations as to
how to proceed.
Senator Jeffords. What remediation technology beside
chlorine dioxide did EPA test?
Administrator Whitman. We did test the chlorine dioxide
liquid as well as the spray, the envirofoam and a number of
other fumigants, disinfectant bleach solutions, chlorine
dioxide liquid, fumigants, chlorine dioxide gas, ethylene
oxide, vaporized hydrogen peroxide, the HEPA vacuuming in
almost every suite that has shown contamination. Every suite
that has shown contamination will be HEPA vacuumed. We have
looked at radiation and destructive disposal which includes
incineration and autoclaving. So we have been pretty thorough
in our review of what is available.
We are, I will tell you, receiving daily more products,
more technologies that have been given to us as new methods to
use. It is wonderful what happens in this country when there is
a problem, how people rise to meet it, and we are in the
process of analyzing all those to see their effectiveness and
fast tracking them to try to move through the process as
quickly as possible.
Senator Jeffords. Did EPA ever consider remediation
technologies that would take the risk of secondary aerosolation
into account?
Administrator Whitman. We looked at everything we thought
was appropriate, where we thought we could not only achieve the
goal of zero contaminant left in the building but also ensure
there was going to be no residual effect from whatever
methodology was used, what we felt we could guarantee and show
was completely out of the building and the buildings were
therefore safe. Actually the CDC will be the final determinator
of when it is appropriate for humans, what they consider to be
safe for everyone. Then the incident commander will determine
when exactly they can move back in.
Senator Jeffords. Now that you have fumigated Senator
Daschle's office, what is the next step? May you have to
fumigate again and are you considering other technologies if
chlorine dioxide does not work?
Administrator Whitman. Right now we are waiting to get the
results from the suite. We should have those by the end of this
week. We have sent them to the labs, the strips and we put in
dishes to do additional testing to make sure both the chlorine
dioxide gas is out of the suite and also that we have achieved
the results of zero trace of living anthrax in that suite. We
should have that by the end of the week. By determining what
that tells us, we will know what the next steps would be. There
are a number of different options that we could do. We could go
back in and fumigate again, we could do the wipe using the
envirofoam or the chlorine dioxide liquid. Those are all
options we would be discussing with the Sergeant at Arms who is
the incident commander.
Senator Jeffords. What lessons has EPA learned about
responding swiftly to an emergency situation in which defined
procedures may not necessarily be in place while at the same
time allowing for public input?
Administrator Whitman. Actually, we have learned that
overall it works very well, that as I indicated to you the
Presidential Decision Directive that gives us the
responsibility to respond in cases of a biological attack is
not perhaps as clear when you start operating as one would like
it to be, that basically when you put aside all the turf
battles, and those went aside very quickly, we found it is
working pretty well. We need to enhance and improve the
monitoring and health safety for on-scene coordinators. That is
an issue of concern. As you may remember, from the beginning
there was discussion of whether they needed to put on the
breathing apparatus right at the beginning; there was some
discussion and concern about what was the appropriate protocol
for protection as it was for you and your staffs of Cipro. We
need current medical monitoring that needs to include a pre-
response screening. We need to have our people ready. It is
something we are looking at in our labs as well.
It is interesting that if you are getting people in the
labs to do the testing on something like anthrax, there is a
real concern about allowing someone who hasn't been either
vaccinated or isn't on something like Cipro to actually do the
testing. Some of those take some time. You buildup immunities
over time and we need to make sure that we know what the
protocols are and that we have the appropriate people who are
appropriately protected responding.
Those are some of the areas in which we would like to see
more attention as we move through this.
Senator Jeffords. What is EPA's protocol for alerting the
public to current or ongoing emergencies, whether that be in a
public building or chemical facility?
Administrator Whitman. The response team is the overall
group that responds in any instance. The Center for Disease
Control is the agency that has the primary responsibility for
determining threats to human health. They will test, we will
test with them, and if we see any indication there is something
that poses a threat to human health, that's when we would
respond with the CDC and alert the public to the extent that is
necessary to ensure their protection. We would do it under the
guidance of the CDC.
Senator Jeffords. Thank you.
Senator Smith.
Senator Smith. Governor, you mentioned a moment ago one of
the options was vaporized hydrogen peroxide. Could you or
anyone on your staff indicate to me why that was ruled out?
There have been some who argued that might have been the safer
procedure and do the job just as well. I am not trying to
second guess you; I am just trying to clarify it for my own
mind here.
Administrator Whitman. I could certainly ask one of the
experts to come up and give you a more thorough response or we
could do it for the record or afterwards, but let me say that
in all instances, we looked at a number of different options
and looked at both the immediate ability to kill the anthrax
spores and the residual impact it might have, and determined
that the chlorine dioxide spray we are using in the Daschle
suite is one that if you maintain the right humidity level and
the right temperature, which we were able to do over the
weekend, proves a very effective agent and at the same time is
one we can assure we can get out of the suites, out of the air
systems and you have to remember is basically something that is
used in everyday products. Chlorine dioxide is used in water,
used to spray on vegetables, so it is something that at the
appropriate levels has no adverse human health effects.
Senator Smith. Was there any contamination found in the
Hart garage?
Administrator Whitman. Not to my knowledge.
Senator Smith. You did test there? Is there a different
vent system there?
Administrator Whitman. Yes, we tested the garage, and no,
we did not find any contamination.
Senator Smith. Because cars were allowed to park there
throughout the entire process, even before you tested, it
seemed a little odd to me that would happen. I am assuming you
haven't ruled out anthrax on any particular floor or section of
the Hart Building when you proceeded. Is the Hart garage under
a different vent system? Is that the issue?
Administrator Whitman. We have tested now every suite in
the Hart Building and tested the garage. A lot of this appears
to be collateral contamination from the original letter. So it
isn't necessarily so that it would get into the entire system,
into the air vent system or be picked up by every employee,
staffer or Senator who had been exposed to it. That somewhat
limited the cross contamination but we did not eliminate
anything when we looked at the building and we have tested all
the areas.
Senator Smith. Was the anthrax in the ventilation system of
the Hart Building?
Administrator Whitman. There was a hit on the Senator
Daschle suite and that was one of the systems that we worked on
immediately.
Senator Smith. No other place in the vents other than right
there?
Administrator Whitman. No, not in the vents. The garage is
on a different HVAC system.
Senator Smith. Have there been any other offices where you
have found more anthrax since the initial hit at Senator
Daschle's office?
Administrator Whitman. There are 11 offices where we have
found traces of anthrax and those are all being treated in ways
appropriate to the level of contamination. The Daschle suite
obviously had the most because that is where the letter was
opened, so there was the most contamination there which was why
we thought it appropriate to use the gas.
As you may remember, originally, we thought we could do the
entire building the same way, just to make extra sure even
though most of or large parts of the building had no
contamination at all, but the engineering of that proved to be
too difficult to ensure the right outcome. So for the Daschle
suite, we used the spray. For the other suites, we are going in
with the envirofoam and the chlorine dioxide liquid and wiping
anyplace that we found contamination, HEPA vacuuming the entire
suite first, then using either the foam or the liquid on all
areas where we got any hits from the testing for anthrax.
Senator Smith. As far as you know, and maybe you don't
know, all of the anthrax found in the Hart Building came from
the Daschle letter?
Administrator Whitman. As far as we know, yes.
Senator Smith. Just in the overwhelming task you have
before you, a giant building, several floors, just in a moment
and not a long answer, how did you go about starting this? What
did you have to do? Did you go floor by floor, hall by hall
trying to secure? Give me a process of how you go about
starting this and working through this?
Administrator Whitman. Initially, NIOSH did the preliminary
testing. They actually followed what they thought to be the
path of the letter itself. We came in when they needed a little
extra help and did some additional testing. We followed the
trail of the mail, where mail would be handled in an office,
where it would be sorted in an office, and that is when we
picked up some additional contamination. We then decided to
test the entire building, every suite and in the suites where
we found any contamination, we tested every room. We were
determined to be as thorough as we could. It was a protocol we
worked out with the CDC, with our other Federal partners and
the private sector and presented to the incident commander.
They had the final approval for what they felt was the
appropriate protocol.
Senator Smith. Thank you. We appreciate the job you are
trying to do. It is a tough job.
Administrator Whitman. We are working on it.
Senator Jeffords. Senator Corzine.
OPENING STATEMENT OF HON. JON S. CORZINE, U.S. SENATOR FROM THE
STATE OF NEW JERSEY
Senator Corzine. Thank you, Senator Jeffords. I appreciate
your holding this hearing, Mr. Chairman. It is always good to
be with Administrator Whitman and renew ties. Unfortunately,
some of those ties come because we have more than a few of
these events seemingly originating in New Jersey.
One of my concerns is are we applying similar standards of
cleanup to New Jersey post offices and other post offices that
we are now establishing with respect to the Hart Building? Are
these protocols going to be administered by the EPA on a
consistent basis across the country if this were to have
greater legs than what we see today?
Administrator Whitman. Although I am somewhat reluctant to
say this to Senators, they are guinea pigs. Neither the
Hamilton Post Office, nor the Brentwood facility have been
decontaminated yet and they are actually watching to see how
the decontamination, the work on the Daschle suite has gone.
That will determine how they are going to proceed. The post
office is the primary responder there. They will make the
determination. We act as consultants. We will provide them with
advice, anything they want but they are the ones who are going
to hire a contractor to do the decontamination.
Senator Corzine. So we won't necessarily have a consistent
pattern of cleanup on how we address this across the country?
Administrator Whitman. No, it depends on the incident
commander. Each site has its own incident commander, but the
other thing that is very important to remember is it really
does matter the type of contamination, where you are finding it
and the type of room. For instance, the post offices in
general, those rooms have heavy equipment, we are able to do a
better job with a wipedown and using either a foam or a
wipedown. As I mentioned earlier, we are looking at a number of
different technologies, so it will depend on the type of
contamination, how much and where we are finding it, and what
we recommend.
Senator Corzine. After we have gone through this process in
several instances, do you think we ought to get to a standard,
not a standardized approach because it happens a different
kinds of facilities, but should there be a standard protocol
with regard to who is responsible for administrating this, who
is responsible for controlling the costs, using the application
that seems most appropriate? It seems the building of
expertise, at least from my perspective, would argue that we
would like to see the same people doing this, not reinventing
wheels on a regular basis.
Administrator Whitman. Actually, there is such a process in
place in the National Response Team. There are the same
agencies that are involved in that. The problem you have with
many of these is you don't want to usurp the authority of the
State or local responders. That is the way emergency response
has gone. We do need to take a look with this kind of
biological terrorism to see whether the Federal Government
should come in more quickly but the CDC is called in almost
immediately on most of these kinds of instances. Also, we need
to remember they are crime scenes, so the FBI is there and they
control the site initially once there is a determination you
have had an anthrax or biological contamination.
We are the ones tasked with being the Federal responders on
biological decontamination when the Federal Government is
called in. We also have the ability if we think a local entity
or private entity, whoever is responsible for the cleanup, if
we don't think they have the capability to do it, if we don't
think they have the technical expertise or the willingness to
do it appropriate, we could step in. That would require at this
point getting a court order in order to do that, which is not
something I don't think any of us is particularly anxious to
do. Thus far, it has not been a problem but there is a
procedure in place for how this would occur.
Senator Corzine. The request you made at the end of your
testimony with regard to indemnification and recovery costs,
would those be amendments to the Superfund Act? Is that where
you would most appropriately see those?
Administrator Whitman. That could be one way to do it but
we are using CERCLA because that is the money we have for
emergency response, but it would not be inappropriate to have a
separate indemnification. It would be under CERCLA, under
Superfund.
Senator Corzine. Finally, several weeks ago we had a
hearing on chemical security. You and I had some discussions
about preparation and timing in which one might want to comment
on some of the elements of that. I was curious whether you had
a chance to move forward with the review and whether you would
be available on that subject?
Administrator Whitman. We certainly appreciate the goals of
the legislation and we have submitted our comments to OMB, so
we are getting close to an Administration position which would
allow us to comment.
Senator Corzine. I would suspect after the first of the
year, we would like to revisit that. It continues to be a
concern that I hear quite frequently from constituents and
others.
Thank you.
Senator Jeffords. Senator Voinovich.
OPENING STATEMENT OF HON. GEORGE V. VOINOVICH, U.S. SENATOR
FROM THE STATE OF OHIO
Senator Voinovich. Thank you for holding this hearing this
morning, Mr. Chairman, and thank you for being here,
Administrator Whitman.
There is a lot of uncertainty in the country today and a
lot of anxiety. How soon did you get involved with the Hart
Building?
Administrator Whitman. We were asked to get involved with
the Hart Building as an observer providing just some expertise
right from the beginning and we started to do the testing
toward the end of October. We got involved in the actual
testing. We were up there providing some advice from the
beginning.
Senator Voinovich. There was a great deal of confusion and
I am still unhappy about the information we got, particularly
when I told my staff members not to get their nose swabbed, it
wasn't necessary and that they were fine, and we then woke up
and read in the paper that things were different. I think that
kind of information, what happened at the post office, two
postal workers are dead today because it could have been
handled differently. We got the mail and nobody was concerned
about the post office where the mail was run through.
I am interested in the Hart Building and frustrated about
it like a lot of others. I would say, one, I would hope we are
going to have some witnesses here and I know it is a learning
experience to a degree for your agency, but I would be
interested after it is over that good records are kept about
whether this works or doesn't work and also that there are
others out there with products on the market, and I would hope
you would give them an opportunity also to be tested so there
is some kind of good housekeeping, whatever it is you can give
to people to say yes, this works because hopefully we are not
going to have a repeat of this but if we do, I think people
ought to know the next time around, we will be in a lot better
shape to respond than we have been able to do thus far.
The area I am really concerned about is the post office.
Are you involved with the post office?
Administrator Whitman. We are just providing advice to the
post office. They are the primary responders and are taking
responsibility for that. I can give you a timeline if you would
like for the Hart Building too. I would be happy to submit that
for the record if you want, of when we came in, what CDC did,
and they established the human health aspect. That is not
something we do. Our primary responsibility is decontamination.
We don't even usually do the testing.
Senator Voinovich. You are not involved in the post office
except as a consultant?
Administrator Whitman. Except in providing them sage
counsel and advice in everything we have seen. That is why I
indicated they are waiting to watch, to see how successful the
decontamination of the Hart Building is, particularly the
Daschle suite activities undertaken last weekend. Predicated on
that, I think they will move forward with a similar type of
decontamination.
Senator Voinovich. I would hope you would share with your
colleagues in the Administration how important the post office
situation is because there is much anxiety in the country
today. I have constituents that say they don't want us to
respond to any letters they get from Washington.
Administrator Whitman. That could be something they wanted
all along, Senator.
Senator Voinovich. I have a daughter-in-law that says, Dad,
I don't want any mail from Washington anymore. I think that is
something that is adding to the fear. There is a lot of fear in
our country today. I think those of us in Washington really
don't get it. It is pretty severe. I think it is really
important that in the process of doing the Hart and some of
these other things, that we get some good information out there
to the American people about the fact that we are a lot better
prepared to deal with any new things and certain areas they are
concerned about, they ought not to be concerned about them.
Administrator Whitman. We will be providing an
administrative record that is a public document at the 60-day
time period that will indicate everything we have done, what we
have looked at and will be available to anyone to see. We are
working closely and as you indicate, there is a lot of concern
in the country. The Center for Disease Control is the one
setting the standards and making the determination as to what
is safe for humans. We follow their lead and provide
decontamination to reach the goals they set for that
decontamination process. We have been working very closely
together.
On your other issue of alternative methods of
decontamination, we have about 30 new products that have been
submitted to the agency since the anthrax letters first turned
up in early October. We are fast tracking that to the degree
possible to ensure they do achieve what they say they are going
to achieve, that they are safe to be used in these instances,
and try to get them out there. I do believe along with you that
by the time we are finished with this, we will be very much
more able to respond, will have many more options at our
disposal and a wider range of options, so we will be able to
get things done faster. We are literally writing the book as we
go along right now.
Senator Voinovich. Mr. Chairman, if possible, I would like
us to get a request out to the Administration to Governor Ridge
about just how is the Administration coordinating all this? Who
is responsible for what? Who is the quarterback? You said you
weren't involved except as a consultant with the post office.
Who actually is the one in charge? Is it CDC that is calling
the shots at the post office? Who is in charge?
Senator Jeffords. I will be talking to Governor Ridge. We
are arranging a meeting now, so I will extend those questions
to him.
Administrator Whitman. Let me say the incident commander in
all those instances is the final arbiter of what advice they
take, what is safe. They take the advice from EPA, CDC, the
Army, from a lot of different people but it is up to them at
the end of the day to make the determination. In the case of
the post office, the post office is the incident commander.
Here, it is the Sergeant at Arms.
Senator Voinovich. Thank you.
Senator Jeffords. Senator Clinton.
OPENING STATEMENT OF HON. HILLARY RODHAM CLINTON, U.S. SENATOR
FROM THE STATE OF NEW YORK
Senator Clinton. Thank you, Mr. Chairman.
I want to associate myself with the questions and comments
of both Senator Corzine and Senator Voinovich on the matter
concerning the protocol for use and the responsibility for
overseeing the response to anthrax. I appreciate very much your
describing to us in your written testimony, as well as here,
what you are doing.
I think we do have a lot of questions we need to answer.
There are questions everyone is trying to answer. There isn't
any standard response out there yet, but that is what we are
intend upon learning and trying to create. On October 26, I
actually wrote to the Postmaster General and the Centers for
Disease Control asking we begin the process of trying to adopt
a standard protocol. We look forward to working with EPA and
every other agency that is affected.
The impact on my colleagues, including EPW staff because of
the discovery of anthrax and its effects in Hart have been
extremely difficult. We know it is even more so for our
citizens who have been working in post offices. I want to be
sure that whatever we do, we do for everyone, that we don't
have some special treatment for Members of Congress as opposed
to people working in postal offices or any other facility.
One question I would have specifically out of your written
testimony is the agency has apparently approved two pesticides
for treating anthrax spores under emergency exemption
provisions of existing pesticide laws. I would like written
response and more explanation of what that means. How does it
work? I believe the emergency approval was to permit actions to
be taken in postal facilities. I, along with my colleagues,
hope we are getting good information about comparing what we
have done in the Hart Building with comparing the use of the
aqueous solution of chlorine dioxide and a foam of some kind,
just so we know what we are learning and what we are doing.
I would also be interested in how you are currently paying
for the work you are undertaking since I believe you asked in
your testimony for, among other things, the ability to recover
cleanup costs. How is that being paid for now?
Administrator Whitman. Right now, we are working under
CERCLA. We have spent about $7.5 million to date nationwide. We
expect that to get significantly higher before we are finished
with it. The Senate has agreed to pay for the decontamination
here. That is an area where we have some concerns. There is not
a responsible party here in the traditional sense because this
was done by a third party unknown to everyone who has been
impacted by it thus far. So we are using our CERCLA moneys at
the moment to do that.
Senator Clinton. I would just note in Senator Byrd's
Homeland Defense package we will be considering this week,
there might very well be some funds that could be used to
reimburse EPA for the work it is doing right now.
On a different environment and public health issue, I would
like your response about Ground Zero and the area surrounding
the World Trade Center. As we all are unfortunately aware, the
fires are still burning. If you saw the paper today, there is
going to be an effort to remove the gas that was used to cool
the towers, something that is extraordinarily difficult to
undertake. Certainly, I hear from a lot of people complaining
about the air quality asking questions about the environmental
and public health concerns, whether it is asbestos, dust or
high levels of benzene or thousands of gallons of PCB laden oil
being released.
I sent a letter on October 26 expressing my concerns on
this issue and requesting a meeting and I was scheduled to meet
with Assistant Administrator Maryanne Horinko, who I am pleased
to see is here. Unfortunately, she had to cancel that meeting
last week which I hope will be rescheduled for this week. I
look forward to meeting with you because I think it is
imperative that we make every effort to provide the best
possible information to people about what is happening in the
air quality testing and that the public can make decisions
concerning their own well being.
One of the big issues we are facing right now is whether to
bring elementary school children back down to Ground Zero to be
in their schools again. I don't know what to tell parents. I
don't know what I would do if I were the mother of an
elementary school child. We did reopen Stuyvesant High School.
The kids are going to school, the air is being tested but there
is a lot of what we are now calling World Trade Center cough,
respiratory asthma problems and no one is quite sure whether we
should go with the younger children.
Mr. Chairman, I think this would be a good matter to hold a
hearing about when we get back after the holidays to try to
figure out what we should be doing and how we can provide good
information.
Finally, I couldn't have the Administrator appear before
the committee without asking about the Hudson River cleanup. I
would like, if I could, a brief update on the record decision
and when you expect that to be sent to the State. I know the
Governor and many of us have been working very hard behind the
scenes to make sure this was carried out the way we believe it
should be. We are opposed to the agency including performance
standards. I hope you are going to be able to give me some news
today about where we stand in that process.
Senator Jeffords. I am sorry, your time has expired.
[Laughter.]
Senator Jeffords. Please proceed.
Administrator Whitman. We hope to have that out very
shortly and I mean very shortly.
Senator Clinton. Is that within the time period that I am
no longer able to--very surely by the end of this week?
Administrator Whitman. I hope so.
Senator Jeffords. Thank you very much. We deeply appreciate
your help and we will be continuing to communicate with you and
try to get a better understanding of where we are and where we
are going.
A question I would sort of like to end with is when does
zero arrive in determination of a risk in these situations?
Those of us involved with farmers know that anthrax is in the
fields and yet we seem to be looking for one spore to close
things down. What kind of guidance do we have as to when it is
a sufficient problem to take action?
Administrator Whitman. Senator, there is no background
level that has been determined of anthrax in an urban setting
or in buildings and that is why at the moment the goal
advocated by the CDC is zero. That is what we are operating
toward. We have cleaned up three offices thus far in the Hart
Building and they are showing no sign of contamination. They
have been successfully remediated. We have remediated a couple
of post offices--we have overseen the remediation of a couple
of post offices in Florida where they did call us in, Brentwood
they have not, to take a more active role and those have been
cleaned and show no background. So we are comfortable that we
will be able to reach that understanding.
As you say, anthrax is a naturally occurring agent, not in
the kind of form and milled to the fineness that the anthrax in
the letter to Senator Daschle was milled. That was very
refined. It was able to get through the envelope itself without
having been opened. They are finding that in fact it could get
through the paper itself. So this is a different type of
contamination of anthrax, but the CDC is looking at and will
make the determination of what is safe, whether there is a safe
level of anthrax for human exposure. Until that time, until
they make that kind of determination, we will be going for the
goal of zero anthrax and thus far, we have seen that.
Senator Jeffords. You mentioned that the Presidential
Decision Directive No. 62 needs improvement. What changes do
you think may be necessary to strengthen the Presidential
Decision Directive No. 62 and do you anticipate recommending
these changes to the President?
Administrator Whitman. We are working very closely with the
Office of Homeland Security through lessons learned on this
whole issue, analyzing where we think there could be better
coordination, where we feel there is more need for focus. For
instance, as I indicated, what do we need to provide our
responders. We have had people in the Hart Building from the
very beginning. Initially they didn't have all of the
protective gear that they now are wearing, although we took
extra steps right from the beginning but we need to come to a
better understanding of how those determinations are made and
coordinate that more closely.
Senator Jeffords. Senator Voinovich.
Senator Voinovich. I would like the statement I have
prepared inserted in the record and I have no further
questions.
[The prepared statement of Senator Voinovich follows:]
Statement of Senator George V. Voinovich, U.S. Senator from the State
of Ohio
Good morning, Mr. Chairman. I would like to thank you for holding
this important and very timely hearing into the remediation efforts of
biological contamination of buildings.
Since the first time anthrax was used as a weapon of terror, the
one thing that the American people want is information, such as what to
look for, how to avoid exposure and how best to deal with contaminated
mail. Unfortunately, the availability of this kind of information has
been spotty, at best. Since October 15, I have personally been very
frustrated with the quality and reliability of the information
regarding the anthrax contamination here in Washington, including the
clean-up efforts.
Like many of my colleagues, I was originally told that my staff and
I were safe in our office on the 3rd floor of the Hart Building, that
we had nothing to worry about. As news stories trickled out that the
spores in the letter mailed to Senator Daschle were of a pure and
highly potent variety, I was still informed that my staff and I had
nothing to worry about and that we should go about our daily routine,
even though several members of my own staff who work for the Senate
Governmental Affairs Committee on the 6th floor of the Hart Building
were put on a 60-day regimen of Cipro. Two days later, I read in the
Washington Post that the Capitol Attending Physician recommended that
anyone who was in the Hart building, even for just a short while, over
the previous 2 days should be tested for anthrax exposure: Senators,
staff, constituents, couriers--everyone.
While we here in the Senate were expressing our concern over and
reacting to our specific anthrax situation, workers at the Brentwood
Mail Facility--where the letters targeting Capitol Hill were
processed--were evidently unaware that letters laced with anthrax had
passed through their building. Even more frustrating to me and to many
others is the apparent fact that the safety and well-being of postal
workers who handled the contaminated letters was given nowhere near the
same consideration as was given to Senators, staff and visitors.
Because of this inconsistency, two postal workers needlessly lost their
lives.
Last month, I visited two post offices in Ohio to meet with the
workers there to reassure them that people here in Washington are
concerned about their safety. I also let them know that the Federal
Government is doing everything possible to guarantee that they are not
put in danger simply by doing their jobs.
I am also concerned about the more than 50,000 Ohio residents who
have written my office in the last 6 weeks. Like my colleagues, I pride
myself on being able to respond to my constituents in as timely a
fashion as possible. However, given the disruption in the Senate's mail
service, a vital communications link between my constituents and I has
temporarily disappeared.
In fact, it was only just yesterday that we started to get a
trickle of mail. God only knows how we are going to handle the mail in
our temporary quarters when it starts coming in a full force.
Mr. Chairman, the thrust of the anthrax contamination has directly
impacted several of our colleagues here in the Senate as well as their
staff, but it has had the ancillary effect of forcing 50 Senators and
hundreds of staff members from the Hart Building. Over the last 6
weeks, a variety of public officials from Capitol Hill and Federal
agencies debated the best course of remediation for the Hart Building
until one was chosen, and it will likely be several more weeks until we
are able to re-enter our offices.
We can do better, and I am looking forward to hearing from our
witnesses as to how we can do so. One such witness is Mr. Les Vinney,
president and CEO of an Ohio-based company, Steris Corporation Mr.
Vinney has a significant amount of experience handling dangerous
biological and chemical contaminants.
I would be interested in hearing what Administrator Whitman has to
say regarding protocols that are being used in the Hart Building clean-
up effort, particularly since the EPA is typically the regulating
entity over a cleanup project such as this. Since the Agency has come
under criticism for its handling of this cleanup, does this experience
give you a new perspective on the difficulties that companies and other
groups the EPA regulates face on similar projects?
The main thing I want to know is: what lessons have we learned from
this experience and can we assure the American people that we have our
act together? In addition, I have a special interest in ensuring the
safety of the mail and particularly, our U.S. Postal Service employees.
Since future anthrax attacks remain possible, these men and women are
truly on the front lines and deserve our support.
Mr. Chairman, thank you again for calling today's hearing.
Senator Jeffords. Senator Corzine.
Senator Corzine. Administrator Whitman, did I hear you say
that you were invited or requested in the Florida postal
situation and not in others?
Administrator Whitman. We are assuming the role we were
asked to assume in Florida. There were three postal buildings
in Florida where we were asked to actively oversee land be in
the building as they decontaminated. They have moved forward
with decontamination, they hired contractors, moved forward
with decontamination. We have done the subsequent testing.
Senator Corzine. Are you supervising that, the
decontamination in Florida?
Administrator Whitman. We are technical consultants and
coordinators.
Senator Corzine. The whole point I am driving at is the
same one we have heard several times here. One time you are in,
sometimes you are not. I don't think people are going to take
great confidence in knowing that there are broadly different
approaches to this. It is not particularly fair to your staff,
nor certainly not fair to the public at large. If one thought
that the Hart project was going to get the Triple A fashion
treatment and others not, I think there will be serious
misgivings in the public and rightly so.
Administrator Whitman. There is no difference in the
approach taken, be it the thoroughness of the approach taken.
Anything that where we are consulting and acting as technical
advisers, the standards are exactly the same for everybody.
Senator Corzine. If you are acting as technical advisers.
Administrator Whitman. Yes.
Senator Corzine. That is a big difference across the way.
This is not like you are going to have 100,000 incidents. We
hope it is not going to be the kind of thing where you have or
we hope we don't have to have a lot of practice so where the
best practices reside, I think the public has a reasonable
right to expect that we apply them on a consistent basis.
Again, I want to underscore multiple times this idea of
trying to get to best practices and making sure we have a
coherent and consistent protocol on how we deal with this.
Senator Jeffords. Senator Clinton.
Senator Clinton. I just want to be absolutely clear that
EPA has not been asked for help with the anthrax-contaminated
buildings in New York?
Administrator Whitman. No, the NBC buildings were done by
private contractors.
Senator Clinton. And the postal facilities?
Administrator Whitman. In New Jersey, they have not done
anything at the Hamilton facility. That remains closed to date.
We have an on-scene coordinator there working with them.
Senator Clinton. What does that mean? If you have an on-
scene coordinator, what level of responsibility does that
suggest?
Administrator Whitman. If we were to determine that the
cleanup was not thorough enough, that the capabilities did not
exist with the on-scene coordinator or whomever was doing the
actual decontamination, then we could go to court to supercede
them, to come in and oversee the actual decontamination. There
is an entire protocol of response, as you know, that the first
people on the scene usually are the local responders and they
are the ones who are the responsible party for seeing it
through to the end, working very closely with the Federal
Government. They bring in, depending on who is needed, the
National Response Team and that is made up of all the different
agencies. So it depends on what the threat is, what the problem
is, who is involved in it.
Senator Clinton. But you are not involved in Morgan Station
which is the very large postal facility in Manhattan at all?
[Audience response.]
Administrator Whitman. If you could hear that answer?
Senator Clinton. Yes, I did. Let me ask too about the
protocol for dealing with the waste that comes out of these
buildings after they are decontaminated. There was an article
about Tom Brokaw's desk being sent to some waste disposal
facility. Is there an existing protocol yet about what we do
with the hazmat suits, with the vacuum cleaning equipment, with
desks or other pieces of furniture or carpeting that has been
infected? Is the waste going to a hazardous waste facility or
where are we in the process of figuring out what we do with
this?
Administrator Whitman. It is all treated as hazardous waste
and taken to appropriate hazardous waste disposal facilities.
Senator Clinton. Even if you are not involved?
Administrator Whitman. We have an on-scene coordinator who
will make sure that nothing is overlooked in terms of the
public safety. We don't make the final decisions. That is why
Senator Corzine was looking for kind of a set pattern of how it
happens.
There is really a set pattern, there is just not a set
response. What we will do is have an on-scene coordinator, once
there has been a determination that there is a biological agent
that poses a threat to human health, we will have an on-scene
coordinator onsite overseeing to make sure that those handling
the actual decontamination are handling that appropriately and
that the waste is handled appropriately as well. We can't force
them to do things. We don't have the legal authority to force
them to take actions. We can suggest, we can recommend, but the
only way we could force is if we were to go to court to
supercede them as the primary responder.
Senator Clinton. So a city could make its own decisions, a
county. Could a private facility basically decide they were
going to handle it on their own and if there were another
incident in New York, you could have a private company say they
didn't want the New York City first responders, they didn't
want the EPA, they were going to do this all by themselves?
That is all permissible under the law as it currently stands?
Administrator Whitman. They could make that determination
but if it was determined in fact there was an agent there, a
biological or chemical agent that posed a risk to human health,
we would have an on-scene coordinator and if we felt they were
doing something to jeopardize people, then we could go to court
to supercede them but no, you're correct in saying they have
the primary responsibility for decisionmaking.
Senator Clinton. It is clear we have a lot of work to do
thinking this through, Mr. Chairman. I thank you for having
this hearing.
Senator Jeffords. Thank you. You give me great confidence
when you testify that you are doing the things that ought to be
done. I appreciate very much working with you.
Administrator Whitman. Thank you very much, Mr. Chairman.
Senator Jeffords. In our second panel, we are fortunate to
have two areas of expertise. Our first two witnesses will
discuss the individual and community health concerns related to
bioterrorism. Our second two witnesses will discuss various
remediation technologies. I am hopeful we can glean lessons
from our current ordeal by drawing on the depth of experience
these four individuals offer.
First, we are pleased to have with us today, Dr. Patrick
Meehan, Director, Division of Emergency and Environmental
Health, Centers for Disease Control. He will discuss the health
risks of original contaminated residuals after remediation, the
health effects of decontamination, the remedy actions and the
continued health monitoring requirements.
Dr. Meehan.
STATEMENT OF PATRICK MEEHAN, M.D., DIRECTOR, DIVISION OF
EMERGENCY AND ENVIRONMENTAL HEALTH SERVICES, NATIONAL CENTER
FOR ENVIRONMENTAL HEALTH, CENTERS FOR DISEASE CONTROL AND
PREVENTION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Meehan. Good morning, Mr. Chairman, members of the
committee.
As stated, I am Dr. Patrick Meehan, Director, Division of
Emergency Environmental Health Services, Centers for Disease
Control and Prevention. I want to thank you for the opportunity
to discuss CDC's and the Agency for Toxic Disease, Toxic
Substances, and Disease Registries which is ATSDR's role in
support of the EPA in remediating anthrax-contaminated
workplaces.
It is CDC's responsibility on behalf of the Department of
Health and Human Services 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 the deliberate release of
biological, chemical, nuclear or radiologic agents. This task
is an integral part of CDC's overall mission to monitor and
protect the health of the U.S. population.
It is within this context that the CDC has begun to address
preparing our nation's public health infrastructure to respond
to potential, future and current acts of terrorism. Last year,
CDC issued a strategy outlining steps for strengthening
capacity to protect the Nation against threats of biological
and chemical terrorism. This strategy identified five priority
areas for planning efforts. A description of these areas has
been provided in my written testimony which is submitted for
the record.
Since the intentional release of anthrax spores, one of the
areas in which CDC and ATSDR has focused is the identification
and cleanup of contaminated facilities. We have refined methods
for environmental sampling to assess whether anthrax
contamination had occurred. In buildings that has meant
sampling of air and/or surfaces. CDC and ATSDR have issued
recommendations on how to conduct environmental sampling and
how laboratories should analyze those samples. We also
recommended environmental sampling strategies to characterize
the extent of exposure and to guide cleanup.
We issued recommendations to protect first responders,
investigators and cleanup personnel. As buildings were
identified as contaminated, we provided technical input to EPA
and others tasked with cleanup to determine where remediation
was necessary. These recommendations have been widely
disseminated to Federal, State and local health and
environmental agencies and are available at CDC's bioterrorism
website.
Disease experts at CDC are developing strategies to prevent
the spread of disease during and after bioterrorist attacks.
Although there is some data on chemical disinfectants in the
scientific literature, there are no historical data that
indicate the best way to eliminate spores from an office
building or to disinfect a sorting machine as Senator Jeffords
said in his opening statement.
The ability of a disinfectant to kill an anthrax spore is
dependent upon time of contact and concentration and is
mitigated by the amount and composition of material through
which the disinfectant must penetrate to get to the spore. For
many of the cleanup methods being used to kill anthrax spores,
we will not know their effectiveness until we go through the
process. EPA understands this and has sought help from a
variety of sources including CDC and ATSDR to ensure that the
appropriate indicators are used and that post-sampling
strategies are adequate.
With regard to the effectiveness of cleaning, even our most
exhaustive sampling strategies will not identify every spore.
It is unlikely that any cleaning strategy will kill every
spore. However, the EPA should be able to clean and retest to
the point where we are all comfortable that spores have been
killed or removed from surfaces where human contact is likely
to occur. A range of sampling methods and strategies should be
used to ensure the safety of building occupants.
In heavily contaminated areas such as Senator Daschle's
suite and the Brentwood postal facility, fumigation is being
proposed or has been used as the method of cleanup--the use of
fumigants as a potential hazard for cleanup workers, those in
areas adjacent to the buildings, and those that must reoccupy
the buildings. A fumigant that is effective in killing spores
is of necessity a highly toxic agent. The protection of workers
during the fumigation process is a matter of good, industrial
hygiene. EPA, CDC and ASTDR are working together to ensure
remediation workers are protected during the fumigation
process.
EPA works with local public health agencies to ensure that
people in the area but outside of the building being fumigated
are notified and kept at a safe distance. With regard to the
safety of those who will reoccupy the building, it is important
to determine both that the area is clear of fumigant and that
there is no residual health risk. Again, CDC, ATSDR and the
Occupational Safety and Health Administration have developed
exposure limits for fumigants and detection methods are
available to determine when any residual fumigant is well below
established limits. After buildings are cleaned and post-
cleaning environmental sampling has been conducted, CDC and
ATSDR are committed to providing technical input to EPA and
other experts to determine whether the building is ready for
reoccupancy.
As highlighted recently, increased vigilance and
preparedness for unexplained illnesses and injuries are an
essential part of the public health effort to protect the
American people against bioterrorism. Prior to the September 11
attack on the United States, CDC was making substantial
progress toward defining, developing and implementing a
nationwide public health response network to increase the
capacity of public officials, to prepare for and respond to
deliberate attacks on the health of our citizens.
The events of September 11 were a defining moment for all
of us and since then we have dramatically increased all levels
of preparedness and are implementing plans to increase them
even further.
In conclusion, the best public health strategy to protect
the health of civilians against biological and chemical
terrorism is the development, organization and strengthening of
public health surveillance and prevention systems and tools.
Priorities include improved public health laboratory capacity,
increased surveillance and outbreak investigation capacity, and
health communication, education and training at the Federal,
State and local levels.
Not only will this approach ensure that we are prepared for
deliberate terrorist threats, but it will also improve our
national capacity to promptly detect and control diseases not
related to terrorism. A strong and flexible public health
infrastructure is the best defense against any disease
outbreak.
Thank you very much for the opportunity to speak today and
I will be happy to answer questions.
Senator Jeffords. Thank you, Doctor.
Next we welcome Dr. Ivan Walks, director, Department of
Health, Washington, DC. He will discuss the community health
concerns related to bioterrorism and how the Federal Government
can work better to inform and coordinate with local officials.
Please proceed.
STATEMENT OF IVAN WALKS, M.D., DIRECTOR, DISTRICT OF COLUMBIA
DEPARTMENT OF HEALTH
Dr. Walks. Good morning, Chairman Jeffords and
distinguished members of the Committee on the Environment and
Public Works. I am Dr. Ivan C.A. Walks, chief health officer of
the District of Columbia and director of the Department of
Health. With me today is Theodore Gordon, chief operating
officer, Department of Health, and key staff members involved
with the remediation of biologically and chemically
contaminated buildings.
We appreciate the opportunity to testify and commend you
for convening this hearing because the discussion here this
morning further complements our efforts to illuminate the
issues regarding environmental exposures to contamination in
the District of Columbia. This hearing also enhances our effort
to continuously inform the community and involve them in
decisions or procedures designed to address their concerns.
As I mentioned in the hearing on Spring Valley before the
House of Representatives in July 2001, we cannot overemphasize
the importance of an ongoing interaction between the government
and the community. There can be no substitute for an informed
community. That theme has been and will continue to be a
guiding light for our efforts in every community in the
District and in any other effort to prevent disease,
dysfunction and premature death.
Allow me now to turn to the purpose of this hearing, i.e.,
the process that the District Government is guided in
remediating biologically and chemically contaminated buildings
and its progress and successes to date. My testimony will also
cover the challenges that confront the District and the rest of
the country, the new technologies available, and our next
steps.
The Department of Health is relatively unique in that the
Environmental Health Administration is part of our Department
of Health and as such, we are charged with the mission of
protecting human health via the prevention and control of
environmentally related diseases, the prevention of
environmental degradation and the promotion and preservation of
the ecosystem and physical environment in the District.
When carrying out this charge, it is imperative that we
follow a process that is structured but at the same time
flexible enough to allow for stakeholder input. In this regard,
and particularly with regard to time critical remediation, our
process is similar to that described in the EPA's Superfund
Community Involvement Handbook.
The District's process of remediation has as a first step
identifying and defining the problem. Regarding biological
contamination, this step involves both identification of
contaminated regions of a building and all the possible
pathways by which contamination can move beyond the
contaminated zone to other locations within the building.
One of the things that I just discovered as we prepared for
this hearing, because we are the Health Department, reportable
diseases have to be reported to us. If a person is confirmed
with anthrax, by law, they have to tell the Health Department.
If a building is found to be contaminated with anthrax, that
does not have to be reported to the Department of Health. That
is one of those things that kind of makes you go ``hmmm,'' and
we really need to address that as an issue. I don't know if
other jurisdictions have the same concern but certainly, it is
one that we would like to raise at this hearing. Certainly, a
contaminated building could lead to obvious concerns.
After that first step, we then begin to explore various
remediation options. Each option is evaluated with regard to
its technical effectiveness, practical feasibility and the
unintended health and ecological risks to remediation workers
and the adjacent community. For example, with respect to the
Hart Building contamination, when we looked at the process
being proposed, we looked at possible community contamination
from leakage. Where there is an environmental standard for
workers for a 15-minute exposure of 300 ppb, we advised a
leakage standard of 15 as opposed to 300 but actually 15 ppb
exposure and set up air handling and air monitoring facilities
around the Hart Building so that if there was leakage, the
Department of Health would be able to be involved and would
step in.
I think our approach tends to be a bit more aggressive and
maybe we can do that because we are a local health department
but we certainly are very concerned and do our own monitoring
when we are concerned about potential community risk.
In conducting an environmental risk assessment, several
things are considered. First, we must be confident that we
achieve a successful outcome. With regard to each option, we
also have to consider costs, exposure to the government,
community hardship emotionally as well as physically, and
length of time for the cleanup.
We continue to monitor, reevaluate throughout the planning
and implementation stages. From all of those steps a prime
option is then identified and we also focus on a secondary or
fallback option so that we don't have to start from the
beginning in case the prime option is not selected. Once we are
almost certain we have considered all pertinent factors, we
then prepare the plan of action, take it to the stakeholders
for input and buy-in. We learned a long time ago that there is
no such thing as a successful plan if the community doesn't
help make the plan.
A big reason for our success in the Spring Valley community
had to do with the inclusion of that community in our
remediation strategy. We have had several meetings in the
community, briefing its residents on our findings and process
for remediation. In addition, Mayor Anthony Williams assembled
an independent group, the Spring Valley Scientific Advisory
Panel, which includes seven specialists in the fields of
epidemiology, toxicology and environmental health as well as
two representatives from the Spring Valley community.
The Department of Health has had significant experience in
remediating biologically and chemically contaminated buildings
in the District. Within the most recent 18 months we have
experienced Legionella contamination in a correctional
facility, a public school and a health-care facility. We have
had significant fungal contamination of private homes and a
public high school following a flood this past summer. In one
community, private homes and the District Building were
affected by a petroleum spill. Our successes are largely
attributable to how well we communicate with the effected
parties. Of course, we have a highly skilled and professional
group of scientists and engineers who perform the technical
risk assessment and remediation steps discussed above.
However, I must continue to stress the importance of
communication as a key ingredient in any successful remediation
plan.
There are several challenges confronting the District and
the country. A particular challenge is that all health
departments across the Nation regarding biological
decontamination of buildings, is that these remediations must
necessarily take place in a context of emerging science. We are
all traveling steep learning curves with respect to the
technical and medical facts. When we use toxic chemicals to
kill biological agents, the scope of that learning curve must
include stakeholders, both within and adjacent to the affected
locations. In this regard, we wish to recommend one fundamental
public health principle--until we learn whether a clinically
significant minimum microbacterial contamination level exists--
in other words, what does a little bit of anthrax mean--we
should only declare a building to have been decontaminated when
all test samples achieve nondetection levels. I think that is
consistent with Administrator Whitman's earlier testimony.
With regard to community exposure to toxic chemicals, we
must continue to maintain substantial margins of safety with
regard to exposures to people in adjacent communities.
With respect to next steps, as we proceed to climb these
steep learning curves, we need to share information real time
with other State and local agencies. Such information must
include biological sampling protocols, dosing, measuring,
critical bioload levels and most of all, effectiveness data. We
should expect the emergence of new chemical decontamination
methods, rapid measuring technologies and biological detection
methods. Knowledge of their efficacies and protocols should be
widely shared within the public health community.
Thank you for this opportunity to come before you and
discuss this issue and we would be happy to answer questions.
Senator Jeffords. Thank you, Dr. Walks.
Our next witness is Mr. Mike Grosser, technical director,
Nuclear Biological and Chemical Defense Systems, Marine Corps
Systems Command, with a long history of work in the
decontamination field. We can learn a great deal from the
Marines.
Thank you for sharing with us today the technologies that
you have been investigating.
STATEMENT OF MIKE GROSSER, TECHNICAL DIRECTOR, NUCLEAR BIOLOGIC
AND CHEMICAL DEFENSE SYSTEMS, MARINE CORPS SYSTEMS COMMAND
Mr. Grosser. Good morning.
I am pleased to appear before you today to discuss several
decontamination technologies that the Marine Corps and the
Joint ChemBio Defense community have been pursuing. I am
responsible to the program manager for the oversight of these
programs. Although I am not a scientist, I have knowledge of
the origin, the progress and the current status of them.
The Marine Corps has pursued these particular technologies
as possible solutions to a requirement for an environmentally
benign, patient-friendly, and effective personnel and equipment
decontamination method. We did not set out to identify a
specific decontaminant for anthrax-contaminated buildings.
The technologies I will talk about are by and large still
in research and development. They have been considered as
candidates for the joint service family of decontaminating
systems and as tools for use by the Marine Corps' ChemBio
Incident Response Force. While it is possible that one or two
of them may be made available quickly, each has some facet that
still requires research, testing and evaluation.
I will discuss electrochemically activated solutions,
electrostatic decontamination, reactive nanoparticle
technologies and the Sandia National Laboratory's foam
decontaminant.
Electrochemically activated solutions are ECASOL which was
developed in Russia in 1978. The Marine Corps has worked with
electrochemical technologies at Las Vegas, NV and the Memorial
Institute of Columbus, OH to further this technology. ECASOL is
a colorless, odorless, aqueous solution, a mixture of water and
salt that passes through a flow through electric nodule. The
end product then is a decontaminant.
ECASOL is a highly effective biocidal agent. It is
essentially a hypochlorous acid which is a close chemical
relative of bleach. The ECASOL device developed for testing by
the Marine Corps could be used to conduct a test for room and
building decontamination, to conduct proof of principle type
work and to see whether or not we have to apply liquid solution
or if we can aerosolize that product.
It is a highly effective anthrax killer in the laboratory
in developmental tests but requires further testing with regard
to application and to operational effectiveness.
Electrostatic decontamination is currently under
development at the University of Missouri. This research and
development program was started in 1998 and essentially we have
an electrostatically charged mist containing a propriety
photosensitizer that is sprayed onto a contaminated surface and
then illuminated with a pulse UV light source. The
photosensitizer mist will not cause injury to humans or damage
to the environment.
I would like to note that it has not been developed or
evaluated as a room or ductwork decontaminant but rather as a
surface decontaminant. We believe that ESD could be misted into
enclosed spaces, possibly ductwork to effectively neutralize
biological agents. This developmental effort would require some
minor modification of commercial, off the shelf technologies,
some applicators and testing to ensure that proper procedures
are in place to maximize agent neutralization.
Reactive nanoparticle technologies involve a nanoparticle
regime that includes materials with particle sizes ranging
between 1-100 nanometers. Nanoparticles of metal oxide exhibit
extraordinary abilities to react with and thereby destroy
highly toxic substances and chemical warfare agents.
Kansas State University and a commercial adjunct firm,
Nanoscale Materials Inc., have been active since 1995 in
developing metal oxide nanoparticles. Since August of this
year, the Marine Corps Systems Command has aggressively pursued
this technology for a wide range of decontamination
applications. This project is focused on developing a novel dry
powder decontamination technology capable of neutralizing
chemical and biological warfare agents in the effort to get
away from the aqueous decontaminant.
It has shown some promise lately as a biological killer.
This technology could be available for use as early as calendar
year 2003 given the appropriate resources.
Sandia National Laboratory has developed the fourth
technology. This decontaminant designated DF-100 is nontoxic,
noncorrosive, an aqueous foam with enhanced physical stability
for the rapid mitigation and decontamination of chemical and
biological warfare agents.
I believe I heard earlier today that a similar foam has
been used in remediation efforts in congressional office
buildings, although I don't know how effective those efforts
have been yet. The foam formulation is based on a surfactant
system, a solubilized decontaminant. The formulation includes
water soluble powders to enhance the physical stability of the
foam.
Preliminary test results demonstrate very effective
decontamination of chemical and biological agents, something
heretofore not seen by us. The decontaminants I mentioned
earlier are largely biological killers.
The decontamination technology may offer the following
benefits. We believe it could be a single decontaminant
solution for both chemical and biological threats, it may be
rapidly deployed and has a minimal operational logistic impact.
Decontamination demonstrations at Dugway Proving Ground, UT
and Ft. Leonard Wood have shown that DF-100 may be applied with
currently field decontamination systems such as firefighting
equipment or even pressure washers.
In conclusion, I want to thank the committee for inviting
me to present this information. The Marine Corps and the Joint
Chem-Bio Defense Program continues to conduct research and
development and acquisition of all these technologies.
I would be happy to answer any questions at this time.
Senator Jeffords. Thank you again for excellent testimony
in an area in which we desperately need information.
Our final witness, we will hear from a company in an
industry that is sure to grow in the near future. Mr. Les
Vinney is president and CEO of the Steris Corporation, a
provider of technologies for infection and contamination
prevention. Welcome. We are looking forward to the answers.
STATEMENT OF LES VINNEY, PRESIDENT AND CEO, STERIS CORPORATION
ACCOMPANIED BY: PETER BURKE, VICE PRESIDENT AND CHIEF
TECHNOLOGY OFFICER; GERRY REIS, VICE PRESIDENT FOR CORPORATE
ADMINISTRATION; KARLA PERRI, SENIOR ENVIRONMENTAL CONSULTANT,
VERSAR, INC.
Mr. Vinney. Thank you. Good morning, Mr. Chairman and
members of the committee.
Thank you for your invitation and welcome the opportunity
to address you on this critically important issue. I would
request that the formal written statement we provided be
submitted for the record.
I am accompanied this morning by Dr. Peter Burke, vice
president and chief technology officer and by Mr. Gerry Reis,
vice president for Corporate Administration. Also joining me is
Ms. Karla Perri, senior environmental consultant of Versar,
Inc.
Steris Corporation technologies are used every day in
environments where the highest levels of sterility are
required. Health care professionals in virtually every U.S.
hospital and researchers, scientists and the pharmaceutical
industry, including all of the Fortune 50 pharmaceutical
companies use Steris products to sterilize and decontaminate
items from surgical instruments to their equipment and
facilities. These technologies help ensure positive outcomes of
such critical activities as the production of antibiotics, the
development of vaccines and the safety of sensitive medical
devices and implants for humans.
The primary business focus of Steris is to develop and
produce formulations that prevent infection and contamination
and the delivery systems to enable their most efficient use.
When properly utilized these technologies can provide safe and
effective remediation of contaminated materials in whatever
form they may take including entire rooms and their contents.
These technologies can also be put in place to prevent
recontamination and assure ongoing safety, as is their purpose
in the industries we currently serve.
In light of the recent events in our country, we welcome
the opportunity to offer our expertise to help restore
biologically contaminated facilities for normal use. We believe
that our technologies can help to optimize and improve the
safety of remediation efforts both in their application and
potential residual effects. Toward that end, we have joined
with Versar, Inc., a leader in providing counterterrorism,
environmental, architectural, engineering and related services.
Together, Steris and Versar offer a broad array of
contamination risk assessment and remediation services.
We firmly believe that methods now in use in health care
and scientific settings can effectively decontaminate
facilities infected with anthrax. The reason you have not
previously seen us before your committee is that the large
majority of Steris products are traditionally used in hospitals
and by pharmaceutical companies. As such, we normally have had
or technologies and processes accepted for use under the
purview of the Food and Drug Administration. While many of our
formulations have been registered for specific uses with the
EPA, our decontamination processes have not previously been
registered for such applications as mail and building
decontamination of the kind our Nation is now addressing.
While our past experience gives us very high confidence in
the effectiveness of our technologies, we strongly endorse the
regulatory requirements to test and validate a product
technology prior to allowing its use for specific treatment
applications. In that regard, we have been seeking the
opportunity to demonstrate the efficacy of our product
technologies to meet various remediation needs.
As no bridge exists across regulatory jurisdictions to
enable the more rapid application of these existing
capabilities to meet emergency decontamination requirements, we
have had to develop new working relationships for this purpose
over the last several weeks. We are now working closely with
the EPA to secure the necessary approvals to permit the use of
our technologies for these applications. We are also in
advanced discussions with the Department of Justice on a
potential demonstration project which would serve to validate
the effectiveness of our technologies in decontaminating
anthrax-infected facilities.
The health care and pharmaceutical industries have dealt
with microbial control challenges for many years. As a result,
highly sophisticated prevention and treatment methodologies
have been developed within these industries. While older
technologies such as formaldehyde and chlorine dioxide have
been used in these industries, more technologies such as vapor
hydrogen peroxide and a combination of hydrogen peroxide and
parcetic acid sporicidal compounds have been developed. These
emerging technologies have displaced the earlier technologies
because they offer certain advantages--reduced toxicity,
limited corrosiveness, minimal residual effects and easier
application.
A facility contaminated by highly aerosolized anthrax
spores offers a unique and severe challenge. While these
conditions present a different environment than our more
standard applications, to accomplish proper remediation a
carefully planned approach would be used similar to those
followed in establishing the preventive process for health care
and scientific requirements.
In an appendix attached to my written testimony, we have
presented a detailed plan for systematic biological remediation
of a given facility or area.
Mr. Chairman, in our profession view there is no single
silver bullet for treating biological contamination. This
remediation requires the selective use of multiple
technologies. This approach should result in the least damage
to items within contaminated facilities, assure that each
surface and material is treated with the agent best suited to
its individual needs and therefore, provide the highest level
of decontamination.
In closing, we believe a coordinated effort is needed among
appropriate government, academic, military and private industry
officials. This coordinated approach will permit the
identification, validation and utilization of the safest and
most effective technologies currently available. Careful
development of the proper protocols for this remediation
process is critical to a successful outcome.
What we must achieve is the restoration and maintenance of
safe working environments for all Americans. Steris stands
ready to help.
Thank you for the opportunity to appear before you today
and I would be happy to answer any questions you may have.
Senator Jeffords. Thank you, all of you. This has been
extremely helpful. I have much more confidence as we finish
with your testimony that we are going to make progress and be
able to get things under control. I do have a question or two
for each of you.
Dr. Meehan, how does Hart's current decontamination plan
take into account the greater level of risk to those
individuals who are allergic to, pregnant or have compromised
immune systems and cannot take the antibiotics used to treat
anthrax and/or be more sensitive to the decontamination remedy?
Dr. Meehan. Regarding the antibiotic treatment, antibiotic
prophylaxis of the people who were exposed, CDC has published
very clear recommendations about what antibiotic regimens
should be used including appropriate treatments for children,
pregnant women and in the unusual situation in the Capitol Hill
physician who is overseeing the treatment of the staff in the
Senate building, has worked very closely with us. We have been
in close contact with him as well and we have been present in
the operations center for the Capitol Hill project right from
the beginning, so there has been extensive give and take and
involvement, very clear guidelines on what antibiotic regimens
are appropriate, how to deal with children and pregnant women.
In the unusual case of antibiotic sensitivity, those need
to be dealt with on a case-by-case basis and we are available
to consult with the Capitol Hill medical staff on a case-by-
case basis for those.
Regarding the fumigant that is used, as I stated in my
testimony, there are very clear guidelines for exposure limits
for workers and the general population published by both NIOSH
and OSHA. We will continue to work with EPA to assure that no
one is exposed to any level that would be a health risk to
anyone as they reenter the building.
Senator Jeffords. What steps has CDC taken to educate
doctors about anthrax and what type of system is in place to
educate health providers as quickly as possible in the case of
another biological or chemical attack?
Dr. Meehan. Prior September 11, we had a bioterrorism
preparedness program that had been in development for about 2
years. We have projects with every State health department,
plus the District of Columbia and others, New York City in
particular. During that time we had extensive efforts to work
through the health departments to educate the medical community
about bioterrorism agents and how to detect and treat them.
Since September 11, we have really revved that up. We have had
a number of satellite video conferences targeted to clinicians,
collaborated with the AMA and others on that. We have, through
our Health Alert Network, a computerized, Internet-based system
that goes down to the provider level, almost on a daily basis
provided updates to health departments and clinicians and we
have had an operations center at CDC open 24 hours a day, 7
days a week and have gotten literally thousands of phone calls
from providers out in the community about patient questions.
``Could this be an anthrax case?'' ``What sort of medical test
should I do?''--that sort of thing. I think the medical
community is aware of our availability.
Senator Jeffords. In your testimony, you mentioned the need
to ensure that post-sampling strategies are adequate. What type
of monitoring will you be doing after remediated buildings have
been reoccupied?
Dr. Meehan. Prior to reoccupation, we will work with EPA to
do extensive resampling to assure there are no detectable
spores that would be of any risk to anybody which means
essentially no detectable spores.
After folks reenter the building, we will continue to do
what we have been doing in every community that has had an
anthrax attack. That is to work with the local medical
community and the health department to aggressively monitor the
population for possible anthrax-related disease. We work with
the health departments and thereby work with the clinicians and
the community so that if there is a patient that might
potentially have anthrax, they are reported immediately to the
health department and that particular case is investigated so
we can catch any cases early. We are optimistic that wouldn't
occur, however, but there is a system in place for doing
surveillance and making sure we catch any cases as early as
possible.
Senator Jeffords. Dr.Walks, I agree with you that the
community involvement is a critical component of the emerging
science known as building remediation. I think we have a unique
challenge of addressing an emergency situation while ensuring
involvement of all stakeholders. I am interested in your
thoughts as to how we can improve community stakeholder
involvement in building remediation efforts?
Dr. Walks. I think we have some good examples here locally.
It is unfortunate but maybe useful that this has hit the
Nation's Capitol because a lot of folks have had a chance to
see what has happened here. I think during a time of crisis
having routine, regular, dependable communication with the
public helped. Dr. Meehan certainly played a terrific role in
working closely with us. Our Mayor showed tremendous leadership
in being out front and routinely and regularly giving folks
real time information.
With respect to the Hart Building cleanup, though we have
multiple jurisdictions in the District, if it is the White
House, it is Dr. Tubb; if it is the Capitol, it is Dr.
Reishold; if it is the District, it is Dr. Walks; but we all
seem to communicate pretty well despite that and I think maybe
because of that communication, we were able over a week ago to
have a community meeting to involve the community prior to the
Hart Building remediation and let folks know what was going to
happen and to take on another challenge which is communication
across diverse communities.
When we have something come to an urban area like the
District, like New York, like Chicago, Los Angeles or Atlanta,
you are talking about multiple languages, over 120 languages in
Los Angeles, nearly 100 languages spoken here in the District.
If we don't find a way to communicate across cultures and
across linguistic barriers, then we really don't involve the
community. I think examples of community meetings before plans
are finalized, examples of talking across jurisdictions,
talking across cultures is really how we do that.
Senator Jeffords. What lessons have you as Director of the
District of Columbia Department of Health gleaned from this
experience with bioterrorism?
Dr. Walks. I think the overriding lesson learned is the
tremendous spirit of cooperation and focus that we have seen. I
have said this previously but the CDC was in the District ready
to work on the ground within 3 hours of the first confirmation
that the Daschle letter contained anthrax. I think that is
remarkable. I think what we have seen is a community that has
shown tremendous resiliency. I think we have seen leadership
that is critical.
Maybe the most important lesson learned is early, clear
leadership. I think we have seen Mayor Williams locally, Mayor
Guiliani in New York, stand up in front of the cameras and tell
people what they don't know so folks will believe you when you
tell them what you do know. I think that is probably the most
important lesson learned, that people can respect honest
ignorance. If you don't know and you tell people that, you
build a relationship based on honesty. If we do anything going
forward across the country, we need to trust people with
information, trust that people are not going to panic. We are a
resilient culture across the board and if we know what is
coming, we know what to expect, then we can respond
appropriately and work together. We saw that and the
jurisdictions meant nothing.
The first press conference we had locally about the anthrax
was a regional press conference involving the Secretary of
Health, Georges Benjamin from Maryland, Ann Peterson, who was
the Commissioner of Health for the State of Virginia and I
think those sorts of cross jurisdictional efforts are going to
be critical.
To sum Chapter 1, clear leadership, cross jurisdictional
cooperation, honest information, timely information, I think
those are probably the biggest lessons learned.
Senator Jeffords. Mr. Grosser, I am intrigued by your
testimony. I don't think many of us thought that you obviously
worried about these kinds of things for years in the military,
warfare and all. Which technology you discussed in your
testimony is least harmful to human health and the environment?
Mr. Grosser. Remember, sir, all these technologies are
still in research and development so I need to couch ahead of
time that things may emerge here in the near or mid term that
contradict what I am about to say. I believe we know that
ecosol, the first technology I discussed, is harmless to human
beings and that the effluent, the runoff, after it is
decontaminated, is environmentally benign, so I would say
certainly ecosol.
I do not know about electrostatic decontamination. I know
that it is harmless and the photosensitizer is harmless, the UV
light is harmless but again we haven't tested these
operationally, only developmentally.
Electrostatic particles are still a ways in development and
Sandia foam, I think the EPA is better at answering that than
I. They have more experience with that here recently.
Senator Jeffords. If ECASOL was developed for personal
decontamination and skin contact, what makes you think it will
work on a building and has this ever been used or something
like that on a building?
Mr. Grosser. I am not aware that it has ever been used or
anything like that on a building. What makes us think it would
work is it is an extremely effective anthrax killer. We are
pretty innovative in coming up with implications, operational
techniques to make decontaminants work, both for personnel and
equipment. I don't know what that method would be but given the
opportunity, I think we could develop some operational tests,
some protocols to determine just how effective it might be.
Senator Jeffords. Mr. Vinney, do you agree with the EPA's
determination that chlorine dioxide was the best treatment to
proceed with in the case of the Hart Senate Office Building?
Mr. Vinney. Certainly the Federal agencies responded to the
crisis using what they know and with technologies that have
worked in the past. I think the situation we are dealing with
is unprecedented, of course, and being biological contaminants,
the treatment of biological contaminants is really not new but
is handled in a very different setting and that is in the
medical and pharmaceutical environments.
The technologies the EPA is using today were used by the
pharmaceutical and medical environments previously but there
have been advances and they have moved on to products such as
vapor hydrogen peroxide and others. I think there is certainly
appropriate situations in which chlorine dioxide and the other
types of materials that are being used would be used but you
would have to examine the specific situation and the
environment in which it was going to be used and we have not
had that opportunity obviously.
Senator Jeffords. I want to thank all of you for your very,
very helpful testimony. We reserve the right to continue to
grill you through the mail, so don't get too relaxed but this
has been very helpful to the committee and I thank you for the
effort and time you have put into the presentations and for
answering the questions. Thank you.
[Whereupon, at 11:18 a.m., the committee was adjourned, to
reconvene at the call of the chair.]
[Additional statements submitted for the record follow:]
Statement of Christine Todd Whitman, Administrator, U.S.
Environmental Protection
Chairman Jeffords and members of the subcommittee, thank you for
the opportunity to describe the Environmental Protection Agency's (EPA)
role in combating bioterrorism: specifically, the role in the
decontamination of anthrax in buildings as part of the Agency's overall
mission to protect human health and the environment. I am pleased to
say that EPA's efforts to meet its counterterrorism obligations are
consistent with the President's statement that combating terrorism and
protecting the nation's critical infrastructures are a high priority
for his administration.
There are several Presidential Decision Directives (PDDs) that
specify a role for EPA in counterterrorism activities. PDD 39 assigned
EPA the task of assisting the FBI during crisis management in threat
assessments and determining the type of hazards associated with
releases or potential releases of materials in a terrorist incident.
EPA, as the lead agency for Hazardous Materials Response under
Emergency Support Function (ESF) 10 of the Federal Response Plan, is
also assigned to assist the Federal Emergency Management Agency, during
consequence management with environmental monitoring, decontamination,
and long-term site cleanup. PDD 62 reinforces our mission to enhance
the nation's capabilities to respond to terrorist events. PDD 63 which
addresses the protection of America's critical infrastructure, named
EPA the lead agency for the Water Supply Sector.
Working with our Federal partners, private sector experts, and
drawing upon our considerable in-house expertise, EPA has been
developing new methods and protocols, and standard operating procedures
to deal with this new threat to the health and safety of the American
people. And we have been doing so on a real-time basis. The speed of
our response, however, has not been at the expense of sound science.
Indeed, a team of science experts has been integral to our daily
activities.
epa's role in buildings contaminated with anthrax
Our cleanup experts have been drawing on their years of expertise
and experience, on the talents of scientists in industry and academia,
and on the knowledge available from our Federal partners. Similar
analysis informed the cleanups undertaken at the several postal
facilities and media offices, although since they were of a much
smaller scope, they were more readily addressed.
Our role at a site generally begins after the Centers for Disease
Control and Prevention (CDC) has tested to determine the presence of a
threat and the risk that threat poses to human health. Once a decision
is made to decontaminate a building, EPA and CDC will work together to
advise the Incident Commander about the extent to which a building must
be cleaned to make it safe.
EPA staff has provided expert technical advice to facility managers
throughout the country on issues such as sampling plans, worker safety
and actual site cleanup methods.
This role is a natural fit for EPA's on-scene coordinators,
managers who are experienced in assessing contamination in structures,
soil, water and air-handling systems. On-scene coordinators have
considerable experience at sorting out hazards, quantifying risks,
planning and implementing emergency cleanups, and coordinating among
other agencies, State and local government, and the private sector.
EPA employees are working at the direction of the incident
commanders from other Federal agencies, and report to the U.S. Postal
Service at their facilities and the Sergeant at Arms in the Capitol.
In addition to the activity generated by testing and cleaning,
these sites are also being treated as crime scenes. That is why our
Criminal Investigation Division has been working closely with the FBI
and with local and State law enforcement agencies at the various
contaminated sites. We are assisting the FBI in gathering evidence to
identify the criminals responsible for terrorist attacks.
As we seek to apply the lessons we're learning from all our
decontamination efforts one thing is becoming clear--there's no one-
size-fits-all solution. Each event has to be thoroughly analyzed as a
separate case before we can propose an effective solution.
For example, cleaning a facility that largely contains rugged,
heavy equipment can be accomplished using such methods as foam or
liquid chlorine dioxide--methods that the contents of the building can
stand up to. On the other hand, a facility that contains lots of paper,
office furniture, and electronic equipment needs to be cleaned using
another method--such as fumigation--that won't damage the contents in
the way a liquid would.
Other factors, such as the amount of contamination found, the ways
and extent to which it can be dispersed throughout a building, the
nature of the surrounding area, and the ways in which the building is
used all require additional consideration before proceeding with
decontamination.
The first step in remediating a building is just like the first
step in any cleanup operation and that is to determine the potential
for risk to human health. Anthrax is a known threat to human health,
but the literature is scant on the number of spores that a person must
be exposed to before developing inhalational disease.
The health team that has come together to help us establish the
parameters for defining the extent of contamination and providing
direct health advice to affected individuals has involved a wide array
of experts. The Congress's own Office of the Attending Physician has
played a central role in providing direct medical advice to the people
who work in the affected buildings. EPA has worked with the CDC and the
Agency for Toxic Substances and Disease Registry in the Department of
Health and Human Services in the areas of sampling strategy,
remediating processes and criteria for judging a remediation process to
be effective. In particular, National Institute for Occupational Safety
and Health (NIOSH) within CDC has been extremely helpful as has been
the Department for Labor's Occupational Safety and Health
Administration (OSHA). The Department of Defense, including the U.S.
Air Force's CHPPM group has special expertise because of the potential
that anthrax would be used as a biological weapon in a war setting.
OSHA has been helpful in determining appropriate safety measures both
for the people who work in the buildings and also for the extensive
remediation crews that are at work here. The District of Columbia's
Department of Health as well as their State counterparts, Maryland's
Department of Health and Mental Hygiene, have been consulted regularly.
And EPA's own in-house expertise including toxicologists from as far
away as our Denver office and safety officers from our own nearby Ft.
Meade laboratory have also played a vital role.
Together this group of experts has reached consensus on when
cleanup activities are warranted, and they have also formed a team to
review final cleanup data to make a determination that the buildings
will be safe to reoccupy.
remediation strategies
While we have developed extraordinarily strong working
relationships with numerous partners in developing the appropriate
health and safety standards and in conducting our sampling work, it is
in the area of actual remediation efforts that our collaborations have
been the most broad-based.
The full array of Federal agencies with expertise in remediation
strategies has been involved in helping develop the tools we need to
deal with anthrax contamination. We have consulted with the White
House's Office of Science Technology Policy. Indeed, the President's
science advisor has been at the Incident Command Center, providing a
key link to this Federal Government-wide response.
Additionally, we are gratified by the level of cooperation and
coordination that has taken place between the Federal agencies with
responsibilities for identifying and remediating anthrax contamination.
In particular, we have worked very closely with staff from the Centers
for Disease Control and Prevention in the areas of sampling strategy,
remediating processes and criteria for judging a remediation process to
be effective. NIOSH has been extremely helpful in providing EPA
expertise in the area of worker protection, both for response
operations and in establishing cleanup goals. We also appreciate the
input from the Department of Defense, particularly the Center for
Health Promotion and Preventive Medicine and U.S. Army Medical Research
Institute for Infectious Diseases. The Coast Guard and Marines have
assisted with sampling and cleanup. Finally, the District of Columbia
government has provided invaluable expertise and assistance in
involving the community.
At EPA, our Office of Solid Waste and Emergency Response, the
Office of Pesticides, our Environmental Response Team out of Edison,
NJ, the Emergency Operations Center here in Washington, and the legion
of responders from across the country led by our folks from Region III,
have all played important roles in the cleanup effort.
A number of liquid and foam applications are effective at actually
killing spores. Sandia Foam is a patented product, developed by the
Sandia Labs, that we have been able to use on a number of surfaces.
Similarly, chlorine dioxide in a liquid form, has been an extremely
effective sporocide. We know these techniques work because we have used
them in a number of areas. To address airborne particles, HEPA (high
efficiency particulate air) filter vacuums are able to capture
particles down to less than one-half micron in size. After the
remediation effort is complete, we have resampled these areas and they
have come back clean.
The tools in our toolbox are growing rapidly. Each method, though,
will have to prove its effectiveness before we add it to our Standard
Operating Procedures. And that proof will come from confirmation
samples that are taken after remediation is complete and come back
demonstrating no threat to human health.
epa's counterterrorism incident response activities
As EPA continues to strengthen its counterterrorism (CT) program by
building on the existing national response system for hazardous
materials (hazmat) prevention, preparedness, and response, the Agency
is involved in a variety of activities with Federal, State, and local
officials that include: responding to terrorism threats; pre-deploying
for special events; planning, coordination, and outreach; and training
and exercises. Most recently, EPA was asked to chair the Security and
Safety of U.S. Facilities Group of the National Security Council's
Policy Coordinating Committee for Counterterrorism and National
Preparedness.
EPA established and maintains a National Incident Coordination Team
(NICT) to assure full agency coordination of all emergency preparedness
and response activities including counterterrorism. In the regions, the
Agency's first responders are the On-Scene Coordinators (or OSCs). The
OSCs have been actively involved with local, State, and Federal
authorities in preparing for and responding to threats of terrorism.
EPA's OSCs, located throughout the United States, have broad response
authority and a proven record of success in responding rapidly to
emergency situations.
registration of products
Another principal responsibility of EPA's in anthrax
decontamination is to ensure that the chemicals used to treat anthrax
spores are efficacious and safe. EPA is responsible for registering
pesticides, including these antimicrobial products used to treat
anthrax spores, prior to their marketing in the United States.
Before issuing a pesticide registration, the Agency reviews a
significant body of data to determine whether use of that pesticide
will result in unreasonable adverse effects to humans or the
environment. These data can include information on short- and long-term
toxic effects and examine the potential for exposure under expected
application scenarios. For pesticides that have public health uses,
such as those used on anthrax spores, EPA also critically evaluates
their efficacy. Under emergency conditions, EPA may allow a new use of
a previously registered pesticide or use of an unregistered pesticide
where the Agency has sufficient data to make a safety finding. These
decisions can often be made quickly, based on the data that EPA
receives and reviews.
Responding to the anthrax contamination has presented some unique
challenges to our pesticides program. For example, currently there are
no registered pesticides approved for use against anthrax. Since the
beginning of the anthrax-contamination events, EPA has been working
hard to identify and evaluate existing pesticide products that are
sporicidal, that is, those that kill spore-forming bacteria, even
though such products may not have been tested on anthrax per se.
Since October, the Agency has approved two pesticides for treating
anthrax spores under emergency exemption provisions of existing
pesticide laws--the aqueous solution of chlorine dioxide and a foam
used to treat anthrax-contaminated surfaces. We have identified several
potential chemicals and new technologies which may be effective against
anthrax. The Agency continues to work closely with other Federal
agencies, emergency response teams, and independent experts to develop
effective remediation tools. On the basis of site specific information,
EPA recommends proper methods of decontamination including which
antimicrobial or other substances will be used.
EPA has also established a hotline for venders who believe they
have products that could effectively treat anthrax and has begun daily
briefings to establish routine communication between onsite personnel
and key centers within the Agency who oversee and/or support them. EPA
laboratories are assisting in testing samples from potentially
contaminated sites and the evaluation of antimicrobial products for
effectiveness against anthrax has been made a top priority. In
addition, EPA is using its experience in this situation to develop
approaches to handling future biological and chemical exposures should
they occur.
conclusion
September 11 has changed the world in which we live. EPA continues
to rely on sound science and effective treatment techniques to address
the threat of anthrax contamination in some of our Nation's buildings.
We are proud to be a part of a massive public-private effort to meet
the challenges of this new world.
Thank you for the opportunity to appear before you today. I would
be happy to answer any questions that you may have.
______
Responses by Hon. Christine Todd Whitman to Additional Questions from
Senator Jeffords
Question 1. Who is accountable for building remediation? Is the
Hart Senate Office Building a unique situation? Under what authority
does EPA act to remediate buildings?
Response. EPA has authority under the Comprehensive Environmental
Response, Compensation and liability Act (CERCLA) and an Executive
Order establishing the National Oil and Hazardous Substances
Contingency Plan (NCP), to clean up contamination within a building if
the Agency believes that there is the possibility that the
contamination may leave the building and create a release to the
environment. As part of its efforts, EPA may deploy Federal resources
to do monitoring, sampling, risk assessment, safety and health
analysis, clean up, disposal, and other response requirements.
The EPA may defer to the owner/operator of a facility (whether
private, Federal or State/local) to carry out a response to an incident
involving hazardous substances and oil, if the Agency determines that
they have appropriate response capability. In these instances, the EPA
provides oversight and technical support. EPA has the authority to take
over such responses, if necessary, in order to protect public health
and the environment.
In the situation of the Hart Office Building, the U.S. Capitol
Police and Sergeant at Arms have the lead in carrying out the
appropriate response, and EPA is providing technical support.
Because EPA has never before conducted a response to a biological
agent such as anthrax on this scale, the Hart Senate Office Building is
a unique situation. The experience gained from the Hart cleanup has
provided valuable guidance to the inter-agency National Response Team
for any future anthrax response actions.
Question 2. At the hearing, you discussed an expedited procedure
for approving remediation technologies. I am interested in hearing more
about that. Which remediation technologies are currently on EPA's list,
and what process will you employ to determine further technologies?
Response. The decontamination of anthrax is a rapidly evolving
field, with new technologies continually being advanced and tested. EPA
continues to receive information from vendors of potentially effective
decontamination technologies and we are coordinating with other
agencies to evaluate the effectiveness of these technologies in
decontaminating anthrax. The Agency reviews such claims very carefully
and places priority on those products that appear to be most promising
for use in decontamination plans. The Agency also gives weight to
requests by EPA On Scene Coordinators (such as those on Capitol Hill),
by other Federal agencies, and by the U.S. Postal Service in
determining which products are needed immediately for treatment of
contaminated facilities.
Under section 18 of the Federal Insecticide, Fungicide and
Rodenticide Act, EPA may temporarily exempt products from the
registration requirements for uses which are deemed necessary under
emergency situations. These exemptions are granted after considering
available data and include requirements which ensure protection of
health and the environment. EPA has provided these exemptions for
several antimicrobial pesticides for use as part of decontamination
plans under this expedited process, including chlorine dioxide,
Envirofoam, and ethylene oxide.
At this time, EPA has been notified by and, in most cases, received
information from vendors on the types of products listed below. EPA is
proceeding to evaluate these products on an expedited basis. No product
should be used until or unless EPA has approved or exempted it, and any
product that is used should be applied in a comprehensive program that
involves sampling, cleaning, treating and resampling followed by
retreatment as necessary to ensure effective decontamination.
Liquid antimicrobials: Bleach (sodium hypochlorite) liquid
chlorine dioxide, hydrogen peroxide, hydrogen peroxide and peracetic
acid, hydrogen peroxide and quaternary ammoniums, hydrogen peroxide and
ethanol, hydrogen peroxide and silver, iodine, nanoemulsion,
parachlorometaxylenol, phenolics, quaternary ammoniums, silyl
ammoniums, isothiazolones, silver, and other proprietary mixtures.
Gaseous antimicrobials: Gaseous and fogged chlorine
dioxide, ethylene oxide, vaporized hydrogen peroxide, and vaporized
paraformaldehyde.
HEPA vacuuming
Irradiation
Pesticide devices: ozone generators, electrostatic
systems, chemical/steam systems, and ultraviolet light and ultrasound.
Destructive Disposal: Incineration, autoclaving
Question 3a. I understand that EPA's been doing ambient monitoring
for fine and toxic air pollutants around the World Trade Center site.
But, some health officials have reported that some of the most obvious
acute health problems (eyes, nose, and throat irritation) associated
with the larger, alkaline and caustic particles have been overlooked.
How can we be sure to have a system in place that will monitor for all
possible air pollutants in preparation for any possible future
disasters/attacks?
Response. We can never be completely prepared for such attacks.
Each incident will have unique aspects with respect to its
investigation and evaluation. A more refined and specific approach,
however, may assist us if such an event were to occur again.
Specifically a phased-in monitoring approach, as used at the World
Trade Center, may be a useful initial step. Most events consist of (1)
an immediate response (for example, the visible particles in the air);
(2) a steady state response (for example, you can see the plume from
the fire) and (3) return to pre-incident conditions (for example, the
fire is waning; people are returning to their homes and businesses).
For each stage, different decisions are made as to the appropriate
course of action and the next steps, and at each phase there could be
different monitoring.
Question 3b. Could simple mechanisms like dust masks have assisted
the public with their health concerns?
Response. Dust masks would have been helpful for particles. For
gases, however, a different breathing apparatus and the appropriate
filters would be needed to be effective, and the efficiency of
protection would depend upon mask type and design.
Question 3c. Do you think it would be helpful to have a NAS panel
review the environmental health risks associated with the World Trade
Center site that we can use as a lesson for future incident
preparation?
Response. A NAS panel review of the environmental and health impact
issues surrounding the World Trade Center monitoring efforts would be
useful.
Question 4. The committee has heard from individuals near the World
Trade Center site about their concerns regarding asbestos
contamination. The Federal Government has largely stayed away from
setting indoor air quality standards. Should we be doing more to ensure
that there are such standards, for public places at a minimum, so that
people can be certain of some level of protectiveness across the
country?
Response. The issue of setting national indoor air quality
standards is a complex issue particularly in light of the sheer number
and variability of indoor spaces. Traditionally, indoor air quality has
been left to local authorities. The indoor environment has been
considered to be outside the scope of the Clean Air Act's standard
setting authority. All this being said, however, EPA believes that
Congress and the Administration need to revisit the issue of authority
and responsibility for indoor environmental conditions in the wake of a
terrorist attack. It may be that the current practice, vesting in local
and state governments primary responsibility for indoor environmental
conditions is not appropriate in the wake of an event like September
11th.
Question 5. As you may know, the GAO is currently undertaking a
congressionally mandated study to assess information that Local
Emergency Planning Committees (LEPCs) receive from EPA and elsewhere in
order to respond to chemical accidents and toxic releases. GAO's
initial inquiries have turned up somewhat disturbing news. Many of the
LEPCs don't function as effectively as they could due to lack of
funding, and it is next to impossible to contact them in a coordinated
fashion. Shouldn't EPA or FEMA have a reliable system of alerting these
entities to national, regional or even local emergencies, especially if
it might include a coordinated terrorist attack on chemical facilities?
Is the lack of coordination simply a matter of resources? How much
funding does EPA provide to the LEPCs? Does or should this money come
from fees collected from those facilities that create the risk, i.e.,
chemical, petroleum, etc.?
Response. It is a challenge to distribute timely information during
emergencies. To try and address this issue, EPA's current system relies
on the assistance of the State Emergency Response Commissions (SERCs)
that appoint the Local Emergency Planning Committees (LEPCs). When
there is information that needs to be quickly disseminated, EPA
communicates with the SERCs, who then provide information to each LEPC.
For more routine communications, EPA regularly sends information update
letters to State Commission chairs, and operates an Internet list-serve
to which many LEPCs subscribe. EPA uses this list serve to provide
LEPCs and other subscribers with chemical safety updates and news
items. Following the events of September 11, 2001, EPA used this list
serve to distribute a chemical site security advisory using this
system. EPA has posted on its website a data base of LEPCs with contact
information; members of the public can search for the appropriate LEPC
contact information for their geographical location.
In the years immediately after Congress created LEPCs with the 1986
passage of the Emergency Planning and Community Right to Know Act
(EPCRA), EPA allocated approximately $1 million each year of
programmatic funds for LEPC grants. EPA made these grants using other
statutory authorities, as EPCRA does not include grant authority for
EPA to support LEPCs or SERCs. In the early 1990's, Congress amended
the Hazardous Materials Transportation Act to provide the Department of
Transportation the authority to charge transporters fees and to use
those fees for training and planning grants for LEPCs and local
responders. Some States have established a fee system under which fees
from facilities are used to support LEPCs and the SERC, at different
levels in different States.
______
Responses by Hon. Christine Todd Whitman to Additional Questions from
Senator Corzine
Question 1a. I understand that bleach was used to clean up anthrax
contamination at several New Jersey post offices, as opposed to the
Sandia foam that is being used in the Hart building. Do you have any
studies or data that indicates the relative effectiveness of these two
decontaminants?
Response. EPA does not have data that specifically compare the
effectiveness of bleach and Sandia foam in anthrax decontamination
scenarios. EPA has reviewed available data on Sandia foam and concluded
that it can be used effectively as part of an anthrax decontamination
plan. EPA is currently conducting tests on the use of bleach in anthrax
decontamination plans but has not yet reached definitive conclusions
about the conditions under which it is effective. Under certain
conditions (i.e., hard surfaces, specific pH, adequate contact time)
bleach can be used in a decontamination plan but, as with all chemicals
for use in anthrax decontamination, the cleanup and treatment process
must be followed by a thorough post-treatment sampling of the
contaminated area to ensure that effective decontamination has taken
place.
Question 1b. Who made the decisions about which decontaminant to
use in each place?
Response. For the Hart Building, EPA consulted with a variety of
scientific resources, and selected the decontamination strategy in
consultation with the Incident Commander. EPA has also consulted with
scientific experts and provided extensive technical advice to the U.S.
Postal Service in developing remediation methods and protocols for
cleaning up postal facilities across the country. Overall, we have
found that each site presents unique variables, and requires a site-
specific cleanup plan that targets the most appropriate method for each
contamination scenario.
Question 1c. Are bleach and the Sandia foam equally protective of
human health?
Response. EPA does not have data on these two products with which
to definitively compare their relative efficacy. However, EPA is
conducting the ``AOAC'' sporicidal test on bleach, liquid chlorine
dioxide, and Envirofoam to assure that they are effective at
eliminating anthrax spores. Regardless of the question of efficacy, the
Agency does not believe that either product, when used in accordance
with the specified use directions, would cause any unreasonable adverse
effects to humans or the environment.
______
Responses by Hon. Christine Todd Whitman to Additional Questions from
Senator Smith
Question 1. In your oral testimony at the hearing you asked for the
committee's help in two specific areas relative to remediation of
buildings affected by bioterrorist attacks: limitation of liability and
recovery of costs. Would you please explain in detail both your
understand of current law in these two areas, and set forth with as
much specificity as you are able, exactly what changes you seek?
Response. During the course of our response to anthrax
contamination, EPA faced some issues that we had not previously
encountered during the normal course of cleaning up hazardous waste
sites under the Superfund program. I wanted to alert you to these
important issues. The Agency has continued to work on finding ways to
resolve these issues.
The first issue dealt with contractor reluctance to clean up
anthrax under existing Comprehensive Environmental Response,
Compensation and Liability Act (CERCLA) indemnification provisions.
Given the many unknown factors associated with cleaning up substances
resulting from acts of terrorism, some contractors were reluctant to
perform anthrax cleanup work unless indemnification provided by EPA for
potential Federal liability was also extended for potential state
strict liability risks. Currently, EPA does not have the authority to
indemnify contractors for strict liability to third parties under state
law.
The second issue dealt with EPA's lack of authority to recover
Agency cleanup costs associated with response to materials defined
under CERCLA as pollutants and contaminants. Anthrax is considered a
pollutant and contaminant under CERCLA. Under CERCLA, EPA only has the
authority to recover cleanup costs for response to hazardous
substances. It is unclear, however, whether broader liability under
CERCLA would have a practical impact on the Agency's ability to
accomplish the cleanup of anthrax contamination, because in many cases
the contamination may be caused by an unknown third party. EPA would
like to work with the committee to discuss options to address these
issues.
Question 2. With respect to the remediation of the Hart Building,
press reports state that although the fumigation procedure went well,
the decision was made at the last minute to increase the exposure time
from 12 hours to 20 hours. Would you please discuss this decision, and
in particular outline all factors giving rise to the need to the
increase in time, and state why you felt it appropriate to alter your
plan at inception?
Response. Prior to the fumigation effort for the Daschle suite,
EPA, working with chlorine dioxide industry representatives and the
U.S. Postal Service, performed a number of tests at the Brentwood
Postal facility on the effectiveness of chlorine dioxide in killing
anthrax spores. These tests focused on the key variables which could
influence the effectiveness of the product to kill spores. Those key
factors include: concentration, contact time, temperature and humidity.
Based on those tests, it is believed that a concentration of 750 ppm
chlorine dioxide for 12 hours (or 9000 ppm-hrs) should be the objective
to provide for the most effect kill. A decision was made during the
operation to continue for a longer period of time in order to achieve
the target concentration of 750 ppm of chlorine dioxide for 12 hours.
There were difficulties in the first hours reaching the 750 parts per
million (ppm) of chlorine dioxide concentration.
Question 3. Please discuss, with as much particularity as you are
able, giving reference to all applicable statutes, regulations and case
law, the basis for EPA's authority for having an onsite coordinator
(OSC) for clean-up and/or remediation of a site of a biological hazard,
including but not limited to sites which are contaminated by virtue of
a terrorist attack.
Response. Biological hazards are pollutants or contaminants under
the definition in the Comprehensive Environmental Response,
Compensation and Liability Act (CERCLA) Section 101(33). Section 104(a)
of CERCLA gives the President (who delegated the authority to EPA in
Executive Order 12580) the authority to respond to releases or
substantial threats of releases into the environment of any pollutant
or contaminant which may present an imminent and substantial danger to
the public health or welfare. 40 CFR 300.120, which is part of the
National Oil and Hazardous Substances Contingency Plan established by
Executive Order, sets out the general responsibilities of on-scene
coordinators.
EPA also provides assistance to other Federal agencies engaged in
emergency response activities. For example, under several Presidential
Decision Directives, EPA provides support to the FBI during the crisis
phase of terrorist events and helps the Federal Emergency Management
Agency (FEMA) in the management of the consequences of a terrorist
attack. When the President makes a disaster declaration under the
Stafford Act, EPA also assists FEMA in responding, especially when the
response involves hazardous materials.
Question 4. With respect to your election of chlorine dioxide gas
instead of vaporized hydrogen peroxide, would you please explain, in
specificity, the relative advantages and disadvantages of one over the
other?
Response. Chlorine dioxide gas has more penetrating power than
vaporized hydrogen peroxide. The nature and extent of anthrax
contamination in the Daschle suite required a chemical that can
penetrate into cracks, crevices and porous surfaces. Vaporized hydrogen
peroxide works well only on hard, non-porous surfaces, so chlorine
dioxide gas was the preferred alternative in this setting.
Question 5. Were there other options considered other than chlorine
dioxide and vaporized hydrogen peroxide, such as ozone or other
technologies?
Response. In consultation with a variety of internal and external
scientific resources, EPA considered a number of options. The primary
alternatives that are appropriate for office settings include High
Efficiency Particulate Air (HEPA) filter vacuuming, chlorine dioxide
gas, chlorine dioxide liquid and hypochlorite (bleach) solution.
Question 6. Is EPA working on the establishment of a process and
protocol for seeking out new technologies for consideration to deal
with any future contamination by biological weapons?
Response. EPA's Technology Innovation Office is leading an effort
to collect and disseminate information about technologies to detect and
decontaminate biological agents. We have established a web site
``Technology for Biological Threats'' http://EPATechBiT.org as a
clearinghouse for information about these technologies and their
vendors, and links to other resources pertaining to the detection and
decontamination of biological agents. This website also helps vendors
start the application process to have their antimicrobial pesticide
product reviewed and registered in accordance with the Federal
Insecticide, Fungicide and Rodenticide Act. We are operating a vendor
helpline at (703) 390-0701 and an email address at [email protected]
to field inquiries from vendors of detection, decontamination, and
measurement technologies. EPA's on-scene coordinators, emergency
response personnel, and their contractors who are responding to
incidents involving biological agents receive up to date information on
new products and vendors collected by the hotline on a weekly basis.
EPA is also working closely with the Interagency Group on
Terrorism's Technical Support Working Group (TSWG), jointly chaired by
the Departments of State, Defense and Justice, to develop a formal
process for selecting and approving new technologies for dealing with
terrorism. The Department of Defense recently issued a Broad Agency
Announcement for technologies that support the Federal Government's
counterterrorism efforts, to help identify promising new approaches for
decontamination, and detection of biological threats. In addition, EPA
is working directly with TSWG to review promising new antimicrobial
devices and detection technologies from vendors that have contacted
EPA's Vendor Helpline. Much of the expertise to evaluate these
innovative technical approaches resides in other agencies. TSWG is
providing access to national experts to review and assess vendor
claims.
Question 7. Is chlorine dioxide gas registered with your Agency as
a sporicide?
Response. Yes, chlorine dioxide gas is registered with EPA as a
sterilant to kill spores of bacillus subtilis and clostridium
sporogenes. It has not however been registered specifically for
bacillus anthracis spores. The Agency has approved its use under
section 18 of the Federal Insecticide, Fungicide and Rodenticide Act
for emergency use in anthrax decontamination plans that include
thorough post-treatment sampling of decontamination areas to ensure
effective decontamination.
Question 8. Would you please comment on the suggestion that
chlorine dioxide has actually been occasionally unsuccessful in room
decontamination in the pharmaceutical context?
Response. EPA is not aware of any such problems.
Question 9. You testified at the hearing, in response to one
Senator's question, that Anthrax was detected at one spot in the HVAC
system of the Hart Building. Please describe, in as much detail as
possible, the efforts that were undertaken to eliminate any possibility
of the presence of anthrax in other areas of the HVAC system,
particularly un-tested surfaces.
Response. Hundreds of samples have been taken throughout the HVAC
in an attempt to characterize the existence or location of anthrax.
With the exception of the air handling unit which returns air from the
Daschle suite, we have not found the presence of anthrax. This is
consistent with the understanding that the anthrax in other locations
was the result of the cross contamination of mail with the Daschle
letter or foot tracking by personnel who moved between offices, rather
than an airborne release.
Because of the potential that anthrax spores may exist undiscovered
in the two air handling systems interconnected to the Daschle suite, it
was determined that the most protective approach for public health was
to clean up those air handling systems. This plan addresses both the
air handling units and the connected ventilation ductwork on the return
side of those units.
A number of cleanup options were considered including manual
cleaning, liquid and foams, steam cleaning and fumigants. After
consultation with HVAC experts and personnel with extensive knowledge
on anthrax, it was determined that the most effective technology would
be the application of chlorine dioxide gas. An attempt to fumigate the
air handling systems connected to the Daschle suite was attempted over
the weekend of December 14-16 but was eventually halted due to a number
of mechanical difficulties, coupled with delays in achieving the
optimal level of humidity. After working extensively to correct the
problems which had arisen, the chlorine dioxide fumigation of the HVAC
was implemented between the Christmas and New Year's holidays. This
fumigation effort was successfully performed in that we were able to
achieve our target goal of 9000 ppm-hours of chlorine dioxide.
Subsequent sampling and analysis found no positive hits for anthrax and
showed that a pervasive sterilizing effect had been achieved throughout
the system.
Question 10. Were the protocols you developed for the remediation
of Hart subject to scientific peer review? If so, would you please
submit a summary of all reports generated in that process or processes?
Response. The peer review comments on the proposed fumigation of
the entire Hart Building were submitted to the committee on December
14, 2001.
Question 11. What lessons have you learned in preparing for the
remediation of the Hart Building that will guide you in similar future
projects?
Response. The Agency has gained valuable experience during these
clean-up activities. EPA, in conjunction with the interagency emergency
response team and the U.S. Postal Services is in the process of
identifying a comprehensive analysis of the lessons learned, which we
will share with you shortly. The Agency is committed to working with
you and your colleagues to ensure that should face a similar situation
in the future, we will have full integrated the lessons we've learned
from this experience.
Among the preliminary lessons, EPA recognizes the need for enhanced
and improved medical monitoring and health and safety programs for our
On-Scene Coordinators (OSCs) to ensure they are adequately protected
when they are responding to bio-terrorism events, such as the anthrax
release at the Hart building. Medical monitoring could include pre-
response screening, response treatment (w/anaphylaxis antibiotics) and
post-response followup and medical care for our OSCs, contractors and
other responders. EPA also recognizes the need for more stockpiles of
personal protective gear and key response equipment, including state-
of-the-art field screening and bio-agent detection equipment. The
Agency also needs to examine its alternative biological analytical
capabilities and availability of trained technicians to determine if
they are sufficient in the event additional or larger-scale anthrax/
biological incidents were to occur.
Question 12. Please describe, in as much particularity as possible,
how the EPA came to be involved with the anthrax contamination of all
private entities (such as AMI in Florida), and provide references to
all statutory and decisional law you relied upon in both commencing and
in terminating your involvement.
Response. EPA tailors its involvement at individual sites according
to the complexity of the problem, the urgency of the need, and the
needs of the owner/operator of a facility. EPA has authority under the
Comprehensive Environmental Response, Compensation and Liability Act
(CERCLA) and an Executive Order establishing the National Oil and
Hazardous Substances Contingency Plan (NCP), to clean up contamination
within a building if the Agency believes that there is the possibility
that the contamination may leave the building and create a release to
the environment. As part of its efforts, EPA may deploy Federal
resources to do monitoring, sampling, risk assessment, safety and
health analysis, clean up, disposal, and other response requirements.
The EPA may defer to the owner/operator of a facility (whether
private, Federal or State/local) to carry out a response to an incident
involving hazardous substances and oil, if the Agency determines that
they have appropriate response capability. In these instances, the EPA
provides oversight and technical support. EPA has the authority to take
over such responses, if necessary, in order to protect public health
and the environment.
EPA became involved at the AMI building in Boca Raton, FL, at the
request of the Florida Department of Health as well as the Palm Beach
County Department of Heath. EPA has conducted assessment activities
with the objective of insuring that the building did not pose an
imminent and substantial threat to the surrounding community. The
initial request also included EPA participating in a collaborative
effort with the Health Agencies in determining how the building could
be decontaminated. This action was conducted under the National
Contingency Plan (NCP), developed by Exectutive Order, which authorizes
the Agency to provide a Federal On Scene Coordinator for releases or
potential releases of pollutants or contaminates that may present such
threats. At this time, EPA has concluded that the AMI building
constitutes effective containment for the potential anthrax release,
and doesn't present a threat of release to the environment. The cleanup
of contamination inside the building is the responsibility of the
property owner and operator. This position is also consistent with the
general approach of EPA's CERCLA response program.
EPA was not requested to provide assistance to the agencies (FBI,
State and local law enforcement and health agencies) responding to
anthrax releases that occurred at several sites in New York City. All
assessment or cleanup operations were conducted by the building owners
and operators. EPA has been in communication with the responding
agencies to offer technical assistance, if needed.
In Connecticut, EPA has responded as part of an interagency
investigative team. No contamination has been detected in private
buildings.
Question 13. Please describe, in as much particularity as you are
able, the nature and scope of the EPA's involvement at each anthrax
contaminated building (public or private) in terms of its contamination
with anthrax.
Response. At the American Media, Inc. (AMI) Building in Boca Raton,
FL, EPA conducted comprehensive anthrax sampling to characterize extent
of contamination. The sampling was initiated at the request of the
State Health Department, and conducted with assistance from the Centers
for Disease Control and Prevention (CDC), the Agency for Toxic
Substances and Disease Registry, the U.S. Army Medical Research
Institute of Infectious Diseases, U.S. Coast Guard Strike Team, the
National Institute of Occupational Safety and Health, Palm Beach County
Health Department, and EPA contractors. EPA sampling efforts included
vacuum samples from soft surfaces such as carpet; wipe samples from
hard surfaces such as desks; and air samples. All samples were analyzed
for the presence of anthrax. EPA is currently providing technical
assistance to the owner in developing and carrying out a strategy for
decontaminating the building, including providing information on
cleanup technologies, sampling protocols, and post-cleanup sampling.
EPA will continue to work closely with AMI, along with other health
agencies and local authorities, as cleanup of the AMI building
proceeds.
At five Florida postal facilities and the Capitol Hill complex
(Hart, Dirksen, Russell, Longworth, Cannon, Rayburn and Ford Office
Buildings, as well as the House side of the Capitol), EPA with the
assistance of CDC conducted sampling activities to confirm and
determine the extent of contamination and cleanup activities. Sampling
efforts included vacuum samples from soft surfaces such as carpet; wipe
samples from hard surfaces such as desks; and air samples. All samples
were analyzed for the presence of anthrax. In each of these cases,
EPA's activities were conducted under the overall management of an
Incident Commander provided by the owner/operator of the facility,
which was the U.S. Postal Service (USPS), for the Florida Postal
Facility sites, and the U.S. Capitol Police, for the Capitol Hill
building sites. EPA also conducted cleanup activities at the five
Florida postal facilities and the Capitol Hill Complex. The cleanup at
the Florida postal facilities included decontamination using a bleach
solution. Cleanup activities at the Capitol Hill complex included
construction of isolation barriers in some office suites, fumigation
using chlorine dioxide gas, decontamination by hand of hot spots using
chlorine dioxide liquid and foams, and HEPA vacuuming. After cleanup
activities are complete, EPA will conduct environmental sampling to
ensure the effectiveness of the cleanup actions.
In addition to the postal facilities in Florida, EPA has provided
technical assistance to the USPS for sampling and decontaminating other
postal facilities throughout the country. The USPS is managing the
responses under either its own authorities or as an executive agency
under the NCP.
At other federally owned sites in the DC area, EPA is providing
technical assistance for sampling and decontaminating the facility to
the other agencies involved. In addition, EPA is working with GSA to
provide the assessment and mitigation services needed for the
responses.
Question 14. If any other agencies have to your knowledge had any
involvement either directly or indirectly with the contamination of the
privately owned facilities, please identify each such agency and state
the nature and extent of that agency's involvement.
Response. The Federal Bureau of Investigation (FBI) was involved in
anthrax incidents at the ABC, CBS and NBC media building in New York
City, and the American Media, Inc. (AMI) building in Boca Raton, FL.
The FBI's role has been to identify crime scene evidence and criminal
intent.
The Centers for Disease Control and Prevention (CDC), the National
Institute for Occupational Safety and Health (NIOSH) and the Agency for
Toxic Substance and Disease Registry (ATSDR) provided technical
assistance at postal facilities and the AMI building. CDC assisted with
environmental sampling of the media buildings in New York. CDC and
ATSDR also conducted environmental sampling at the USPS facility in
Wallingford, CT.
The U.S. Coast Guard--Strike Teams provided technical assistance at
the American Media, Inc building in Boca Raton, FL.
The U.S. Army Medical Research Institute of Infectious Diseases
(USAMRIID) provided technical assistance at the American Media, Inc
building in Boca Raton, FL.
The U.S. Army Corps of Engineers (USACE) provided technical
assistance to the USPS for the decontamination of the Wallingford, CT,
facility.
Question 15. Who do you believe is financially responsible for
remedial costs related to anthrax contamination of a privately owned
facility?
Response. Generally, private building owners are responsible for
hiring qualified contractors to conduct sampling and perform whatever
decontamination is necessary. Depending on the insurance coverage in
force, there may be insurance money to defray the costs of cleanup.
When asked, EPA provides an On Scene Coordinator to provide technical
assistance. Under the National Contingency Plan, EPA has the authority
to perform work if the situation exceeds the capabilities of the owner
or state and local responders.
Question 16. With respect to the preceding question, please explain
with as much particularity as you are able, the reasons upon which you
base your answer, making reference to all applicable statutory and
decisional law. Under what statute or under what authority will the
remediation of these contaminated facilities be conducted?
Response. Clean-up of these facilities is authorized under the
Comprehensive Environmental Response, Compensation and Liability Act
(CERCLA). Anthrax is defined as a pollutant or contaminant rather than
a hazardous substance, under the Section 101(14) and (33) of CERCLA.
Under Section 104(a) of CERCLA, the President has the authority to
respond to releases or substantial threats of releases of any pollutant
or contaminant which may present an imminent and substantial danger to
the public health or welfare. This authority has been delegated in
Executive Order 12580. While EPA has broad authority to respond, the
Agency's resources are limited and choices must be made about which
responses to undertake using our limited resources.
CERCLA does not specify which parties are responsible for response
costs associated with clean ups of pollutants or contaminants. Section
107(a) of CERCLA, which specifies which persons are responsible for
response costs, deals only with costs incurred in response to releases
or threatened releases of hazardous substances and not pollutants or
contaminants.
Question 17. Who will establish and enforce the cleanup standard to
be used at these contaminated facilities?
Response. There are no existing standards for cleaning up anthrax
that has been deliberately released into a workplace setting. EPA has
worked very closely with the Centers for Disease Control and
Prevention, the Occupational Safety and Health Administration, the
National Institute for Occupational Safety and Health, the Agency for
Toxic Substance and Disease Registry and other experts, to evaluate the
unique characteristics of each contaminated site, to recommend
appropriate clean-up goals, and to evaluate the effectiveness of clean-
up activities. The clean-up goal recommended to the Chairman of the
Capitol Police Board for the Capitol Hill Complex was ``zero growth,''
which means that there is no viable anthrax detected in any post-
cleanup samples. Clean-up activities continued until this goal was met.
We will continue to work with these Federal experts, and also with
private owners, to recommend appropriate goals and evaluate
effectiveness of remediation at other contaminated sites.
Question 18. What funding source was used to pay for your efforts,
including but not limited to testing, of all non-public buildings?
Response. EPA's activities to address anthrax contamination were
conducted using our emergency response authority. Therefore these
activities were funded from our Superfund account.
Question 19. Please discuss any financial programs that exist that
could be used to partially or fully underwrite the cost to remediate
private facilities, such as Brownfields grants, technical grants to
local health departments and EPA Regional Strategic Geographic
Initiative discretionary grants?
Response. EPA does not have any financial programs to underwrite
the cost of cleaning up private facilities. EPA's Local Governments
Reimbursement program provides Federal funds to local governments for
costs related to temporary emergency measures conducted in response to
releases or threatened releases of hazardous substances. The program
serves as a ``safety net'' to provide supplemental funding to local
governments that do not have funds available to pay for these response
actions. The Comprehensive Environmental Response, Compensation and
Liability Act (CERCLA) specifically limits reimbursement to $25,000 per
single response. CERCLA also specifies that only a small percentage of
the Superfund budget can be used for local government reimbursement.
The $25,000 cap, plus the limited availability of funds for the
program, may not allow EPA to reimburse local governments for all
response costs that may qualify.
Brownfields cooperative agreements could not help underwrite the
cost of remediating private facilities contaminated with anthrax.
Brownfields cleanup actions would not be timely enough. They are
limited to non-time critical removals (i.e., non-emergency activities)
and they must include several procedural steps, including public notice
and comment. Also, private parties are not eligible for direct grants
of brownfields funds. EPA awards cooperative agreements to eligible
local governments, States, and Indian tribes to establish a
``revolving'' cleanup fund. The cooperative agreement recipient may
issue loans to eligible public, private or non-profit borrowers to be
used as cleanup funds for prospective projects.
It would not be appropriate to utilize Regional Strategic
Geographic Initiative discretionary grants for private site clean up,
as these funds are set aside for addressing unique regional/geographic
issues rather than individual sites, working with the local community
and all stakeholders.
Question 20. Have the testing protocols employed by the EPA at the
Hart Building differed in any respect from the testing protocols
employed by the EPA at other similarly contaminated facilities, and if
so, please explain all reasons for this difference, and please explain
the nature of the difference.
Response. Testing protocols may differ, depending on size and type
of the potentially affected areas (e.g., a large open mailroom or
office space with cubicles), how the contamination was delivered (e.g.,
spores in an envelope or by contact with a contaminated surface), how
contamination could be dispersed (e.g., by ``tracking'' from a
contaminated area or through an air handling system), and other
industrial hygiene issues specific to the site. In each case, we
attempted to recreate the likely path of the contamination source and
sample along that path. If we found indications of contamination, we
went back and sampled those areas more comprehensively, and designed a
remediation plan to meet the specific characteristics of that site. Our
knowledge of the effectiveness of different sampling and analytical
methods has been growing day by day, and we are using what we learn to
develop new approaches for future improvements to our response
capability.
Question 21. What will be the EPA's future role in the remediation
of private facilities contaminated by biological warfare agents,
especially in light of Presidential Decision Directive 62?
Response. EPA is currently re-evaluating various response
authorities, including those under the Comprehensive Environmental
Response, Compensation and Liability Act, the National Contingency
Plan, and Presidential Decision Directives 39 and 62, to determine the
appropriate EPA role. We are also consulting with the Office of
Homeland Security on this issue.
Statement of Patrick J. Meehan, M.D., Director, Division of Emergency
and Environmental Health Services, National Center for Environmental
Health, Centers for Disease Control and Prevention, Department of
Health and Human Services
Good morning, Mr. Chairman and members of the subcommittee. I am
Dr. Patrick Meehan, Director, Division of Emergency and Environmental
Health Services, Centers for Disease Control and Prevention (CDC),
Department of Health and Human Services (HHS). Thank you for the
invitation to discuss CDC's and HHS's Agency for Toxic Substances and
Disease Registry's (ATSDR) role in supporting the Environmental
Protection Agency (EPA) in remediating anthrax-contaminated workplaces.
My division includes CDC's National Pharmaceutical Stockpile (NPS) as
well as coordination of emergency preparedness and response activities
under the Federal Response Plan.
Today, I will update you on the intentional release of anthrax and
the number of exposed and affected persons, as well as summarize CDC
and ATSDR's efforts to identify exposure, prevent anthrax disease, and
monitor the health of those known to be exposed. I will also discuss
CDC and ATSDR's collaboration with the EPA to assist in remediating
contaminated buildings and protecting the health of workers in those
buildings.
I would like to begin by emphasizing the importance of remediating
all anthrax-contaminated worksites. CDC and ATSDR have worked, and will
continue to work diligently along with EPA and our Federal, State, and
local public health partners to help achieve this goal. Every worker in
the United States deserves a safe and healthy workplace. In the past 2
months, terrorists have used anthrax spores to disrupt, displace, and
even infect American workers. One phase of the fight against terrorism
is to remediate contaminated workplaces and protect the health and
safety of American workers who need to return to their jobs. We must
also protect those workers whose job it is to investigate and clean
these work places. These are the people who have been on the front
lines of this battle, and they deserve our help and support.
As you are aware, many facilities in communities around the country
have received anthrax threat letters. Most were received as empty
envelopes; some have contained powdery substances. However, in some
cases, actual anthrax exposures have occurred. These cases have been
identified in Florida, New Jersey, New York, Washington, DC, and
Connecticut. This is the first bioterrorism-related anthrax attack in
the United States, and the public health ramifications of this attack
continue to evolve. In collaboration with State and local health and
law enforcement officials, CDC, ATSDR, and the Federal Bureau of
Investigation (FBI) are continuing to conduct health investigations
related to anthrax exposures. During this heightened surveillance,
cases of illness that may reasonably resemble symptoms of anthrax have
been thoroughly reviewed. The public health and medical communities
continue to be on a heightened level of disease monitoring to ensure
that any potential exposure is recognized and that appropriate medical
evaluations are given. This is an example of the disease monitoring
system in action, and that system is working.
public health leadership
The Department of Health and Human Services' (DHHS) anti-
bioterrorism efforts are focused on improving the Nation's public
health surveillance network to quickly detect and identify the
biological agent that has been released; strengthening the capacities
for medical response, especially at the local level; expanding the
stockpile of pharmaceuticals for use when needed; expanding research on
disease agents that might be released, rapid methods for identifying
biological agents, and improved treatments and vaccines; and regulating
the shipment of hazardous biological agents or toxins.
As the Nation's disease prevention and control agency, it is CDC's
responsibility on behalf of DHHS 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 agents. This task is
an integral part of CDC's overall mission to monitor and protect the
health of the U.S. population.
remediation support activities
Since the intentional release of anthrax spores, one of the areas
on which CDC and ATSDR have focused is the identification and cleanup
of contaminated facilities. We have refined methods for environmental
sampling to assess whether anthrax contamination had occurred; in
buildings that has meant sampling of air and surfaces. CDC and ATSDR
have issued recommendations on how to conduct environmental sampling
and how laboratories should analyze those samples. We also recommended
environmental sampling strategies to characterize the extent of
exposure and to guide cleanup. We issued recommendations to protect
first responders, investigators, and cleanup personnel. As buildings
were identified as contaminated, we provided technical input to EPA and
others tasked with cleanup to determine where remediation was
necessary. These recommendations have been widely disseminated to
Federal, State and local health and environmental agencies, and are
available at CDC's bioterrorism website (http://www.bt.cdc.gov).
EPA has devised strategies for remediation and has gained much
experience through its activities to date. Disease experts at CDC are
developing strategies to prevent the spread of disease during and after
bioterrorist attacks. Although there are some data on chemical
disinfectants in the scientific literature, there are no historical
data that indicate the best way to eliminate spores from an office
building, or to disinfect a sorting machine. The ability of a
disinfectant to kill an anthrax spore is dependent upon time of contact
and concentration and is mitigated by the amount and composition of
material through which it must penetrate to get to the spore. For many
of the clean-up methods being used to kill anthrax spores, we will not
know their effectiveness until we go through the process. EPA
understands this and has sought help from a variety of sources,
including CDC and ATSDR, to ensure that the appropriate indicators are
used and that post-sampling strategies are adequate.
With regard to the effectiveness of cleaning, even our most
exhaustive sampling strategies will not identify every spore. It is
unlikely that any cleaning strategy will kill every spore. However, the
EPA should be able to clean and re-test to the point where we all are
comfortable that spores have been killed or removed from surfaces where
human contact is likely to occur. A range of sampling methods and
strategies should be used to ensure the safety of building occupants.
In heavily contaminated areas, such as Senator Daschle's suite and
the Brentwood postal facility, fumigation is being proposed as the
method of clean-up. The use of fumigants is a potential hazard for
clean-up workers, those in areas adjacent to the buildings, and those
that must re-occupy the building. A fumigant that is effective at
killing spores is, of necessity, a highly toxic agent. The protection
of workers during the fumigation process is a matter of good industrial
hygiene. EPA, CDC, and ATSDR are working together to ensure remediation
workers are protected during the fumigation processes. EPA works with
local public health agencies to ensure that people in the area but
outside of the building being fumigated are notified and kept at a safe
distance.
With regard to the safety of those who will re-occupy the building,
it is important to determine both that the area is clear of the
fumigant and that there is no health risk. Again, CDC, ATSDR, and the
Occupational Safety and Health Administration (OSHA) have developed
exposure limits for fumigants, and detection methods are available to
determine when any residual fumigant is well below established limits.
After buildings are cleaned and post-cleaning environmental sampling
has been conducted, CDC and ATSDR are committed to providing technical
input to the incident command and other experts to determine whether
the building is ready for re-occupancy.
challenges
CDC has been addressing issues of detection, epidemiologic
investigation, diagnostics, and enhanced infrastructure and
communications as part of its overall bioterrorism preparedness
strategies. Based on Federal, State, and local response in the weeks
following the events of September 11 and on recent training
experiences, CDC has learned valuable lessons and identified gaps that
exist in bioterrorism preparedness and response at Federal, State, and
local levels. CDC will continue to work with partners to address
challenges such as improving coordination among other Federal agencies
during a response and understanding the necessary relationship needed
between conducting a criminal investigation versus an epidemiologic
case investigation. These issues, as well as overall preparedness
planning at Federal, State, and local levels, require additional action
to ensure that the Nation is fully prepared to respond to acts of
biological and chemical terrorism.
conclusion
In conclusion, CDC and ATSDR are committed to working with other
Federal agencies and partners as well as State and local public health
departments to ensure the health and medical care of our citizens. We
are committed to continuing our partnership with EPA to ensure that the
best public health information is coupled with the best ideas for how
to remediate contaminated facilities. We need to improve sampling
methods and equipment. We must learn from this experience and continue
to assist the EPA in determining the best ways to remediate different
types of workplace environments having different amounts of anthrax
contamination.
Thank you very much for your attention. I will be happy to answer
any questions you may have.
______
Responses by Tracy Meehan to Additional Questions from Senator Jeffords
Question 1. Although the risk of secondary aerosolization is very
slight, there is still a risk. Therefore, what precautions are you
proposing? What are your thoughts on post-exposure vaccination?
Response. On December 18, 2001, the Department of Health and Human
Services released a statement on their recommendations for post-
exposure vaccination and continued prophylaxis. The introduction of
this release reads as follows:
Many of those who were exposed to inhalational anthrax in the
recent mail attacks are presently concluding their 60-day course or
preventive antibiotic treatment. Some of these persons especially those
who may have been exposed to very high levels of anthrax spores, may
wish to take additional precautions. The Department of Health and Human
Services (HHS) is providing two additional options beyond the 60-day
antibiotic course, for those who may wish to pursue them: an extended
course of antibiotics, and investigational post-exposure treatment with
anthrax vaccine.
HHS will make anthrax vaccine available to those who were exposed
to inhalational anthrax, who have concluded their antibiotic treatment
and who wish to receive the vaccine as an investigational product. The
vaccine is being made available in this investigational mode, under an
investigational new drug application (IND) at the option of the
individual, in recognition of the limited nature of the data now
available concerning inhalation anthrax treatment and the factors
underlying development of the disease, as well as uncertainty
concerning the extent of exposure to spores that some persons may have
received in the recent anthrax incidents. The decision to use this
vaccine is at the discretion of the individual, in consultation with
his or her physician.
The complete document can be accessed at: http://www.hhs.gov/news/
press/2001pres/20011218.html.
Question 2. Can you describe the protocol used to assess potential
health risks of a chemical or biological attack?
Response. Since there are a number of agents which can produce a
biological or chemical attack and a variety of exposure routes, each
episode is investigated to determine the public health risks based on
the scientific circumstances of the incident. The investigation process
includes an epidemiological investigation to determine the source and
mode of transmission and define the at-risk population; a laboratory
investigation to define the agent; an environmental assessment to
detect any potential exposure to a chemical or biological agent,
including how long the exposure lasted; an evaluation to detect any
evidence of clinical disease; and a followup to determine any potential
long-term health risks.
Question 3. I understand that you have received test results of
various remediation technologies, for example about ECASOL. What are
your impressions of those test results?
Response. We evaluate remediation technologies based on past
history with that technology, published studies, experience in cases of
biologic contamination, and the effect of the technology on the
contaminated media. Some technologies, such as ECASOL are new,
experimental, or have only been used by the military and will require
further review. Others, such as sodium hypochlorite and Sandia Foam
show some evidence of effectiveness against anthrax spores, and we
recommend their use with appropriate followup sampling on a case-by-
case basis.
Question 4. Much of the level of risk associated with anthrax
exposure depends on the degree to which anthrax is treatable with
antibiotics. How does your protocol account for individuals who are
allergic to, are pregnant or have compromised immune systems and cannot
take the antibiotics used to treat anthrax without putting themselves
at serious health risk or inflicting serious harm on unborn children?
Would you agree that the potential risks associated with anthrax
contamination are greater for an individual who is in some way limited
in the antibiotics available to them?
Response. Antibiotic regimens are available that include
alternatives for persons in the described groups. The following MMWRs
contain interim recommendations for alternative prophylaxis:
Notice to Readers: Update: Interim Recommendations for
Antimicrobial Prophylaxis for Children and Breastfeeding Mothers and
Treatment of Children with Anthrax. Vol 50, No 45;1014 11/16/2001
http://www.cdc.gov/mmwr/PDF/wk/mm5045.pdf
Notice to Readers: Updated Recommendations for Antimicrobial
Prophylaxis Among Asymptomatic Pregnant Women After Exposure to
Bacillus anthracis Vol 50, No 43;960 11/02/2001 http://www.cdc.gov/
mmwr/PDF/wk/mm5043.pdf
Question 5. Can you identify for me how you determined which
individuals should be taking 60 days of antibiotics? Even for those
that tested negative for anthrax, you have suggested this regiment, in
effect prescribing Cipro as a preventative measure? How may this
protocol change in the future?
Response. Sixty days of prophylactic antibiotics were recommended
for persons who had significant exposure to powder containing anthrax
spores or were in environments in which they were at risk of exposure
or where there were cases of inhalational disease. The nasal swab tests
which were conducted in some settings were not done for diagnostic
purposes, and a negative nasal swab did not mean that a person was not
exposed to anthrax. The test was used mainly for epidemiologic purposes
to determine an area where people were likely exposed and for forensic
purposes. Decisions regarding which groups of individuals should
receive prophylaxis were made in collaboration with Federal, State, and
local health officials and partners in the areas impacted over the
course of the investigation.
Many of those who were exposed to inhalational anthrax in the
recent mail attacks are presently concluding their 60-day course of
preventive antibiotic treatment. Some of these persons, especially
those who may have been exposed to very high levels of anthrax spores,
may wish to take additional precautions. The Department of Health and
Human Services (HHS) is providing two additional options beyond the 60-
day antibiotic course, for those who may wish to pursue them: an
extended course of antibiotics, and investigational post-exposure
treatment with anthrax vaccine. HHS will make anthrax vaccine available
to those who were exposed to inhalational anthrax, who have concluded
their antibiotic treatment and who wish to receive the vaccine as an
investigational product.
The complete document can be accessed at (http://www.hhs.gov/news/
press/2001pres/20011218.html.)
______
Response by Tracy Meehan to Additional Question from Senator Corzine
Question. As we clean up the anthrax mailed in October, we should
be thinking about how we prevent future incidents in the future and
mitigate the effects of any incidents that do occur. One of the ideas
that has been discussed in this regard is vaccination. Do you think
that the anthrax vaccine should be made available an on option to
postal workers and others who may be at high risk for future anthrax
exposure?
Response. Supplements to the December 15, 2000 ACIP recommendations
that concern the use of anthrax vaccine are currently under review at
CDC and HHS. These include persons at potential repeated exposure to
anthrax. Examples include laboratory and decontamination workers.
Postal workers have not been demonstrated to be at similar risk.
______
Responses by Tracy Meehan to Additional Questions from Senator Smith
Question 1. Please state the date of your first involvement with
the decontamination and remediation of:
(1) The Hart Building.
(2) The AMI Building.
(3) The NBC Offices.
(4) The New York Post Offices.
(5) The West Trenton, NJ Postal Facility.
(6) The Stevens' home.
(7) The New York City Office of Gov. Pataki.
(8) The Boca Raton Postal Facility.
(9) The Brentwood Postal Facility.
(10) The Ford Office Building.
(11) The Ottilie Lundgren home.
Response. In all of the sites involved in the recent anthrax
episode, discussions regarding site decontamination and remediation
were woven into the overall public health investigation and response.
Therefore, rather than specify dates of first involvement with
decontamination and remediation, we are providing dates CDC initiated
onsite investigations related to anthrax in each of these locations.
Florida, October 4.
New York City, October 12.
New Jersey, October 18.
Washington, DC, October 15.
Connecticut, November 20.
Regarding the specific locations listed, it should be noted that
there was never any anthrax detected in the environmental samples taken
from the Stevens and Lundgren homes. Therefore, CDC is not aware of any
issues regarding decontamination and remediation in these locations. In
addition, CDC was not involved in the investigation of the New York
city office of Governor Pataki. This sampling and cleanup activity was
conducted by the New York State Department of Health; CDC did provide
some support for specimen confirmation. In the other settings, CDC
served in a consultative role to the incident command, the
Environmental Protection Agency (EPA), and to state and local health
and environmental authorities.
CDC works closely with the EPA to evaluate human health risk from
environmental anthrax contamination and the adequacy of
decontamination. As noted from Governor Whitman's previous testimony
before Congress, decontamination is an EPA responsibility:
Under the provisions of PDD 62, signed by President Clinton in
1998, the EPA is assigned lead responsibility for cleaning up buildings
and other sites contaminated by chemical or biological agents as a
result of an act of terrorism. This responsibility draws on our decades
of experience in cleaning up sites contaminated by toxins through prior
practices or accidents.
Since the intentional release of anthrax spores, CDC and ATSDR
focus has been on the identification and characterization of anthrax
contamination in facilities either where cases have been identified or
which have been associated with the investigation (such as
``downstream'' mail facilities), in addition to the clinical,
laboratory and epidemiologic investigation of the cases of anthrax
infection. We have refined methods for environmental sampling to assess
whether anthrax contamination had occurred; in buildings that has meant
sampling of air and surfaces. CDC and ATSDR have issued recommendations
on how to conduct environmental sampling and how laboratories should
analyze those samples.
We also recommended environmental sampling strategies to
characterize the extent of exposure and to guide cleanup. We issued
recommendations to protect first responders, investigators, and cleanup
personnel. As buildings were identified as contaminated, we provided
technical input to EPA and others tasked with cleanup to determine
where remediation was necessary. EPA, CDC, and ATSDR are working
together to ensure remediation workers are protected during the
fumigation processes. After buildings are cleaned and post-cleaning
environmental sampling has been conducted, CDC and ATSDR are committed
to providing technical input to the incident command and other experts
to determine whether the building is ready for re-occupancy.
Question 2. Another witness at the hearing testified that the
standard for certification of safety to re-occupy the Hart Building,
and impliedly any contaminated building, following remediation, is that
100 percent of all tests for spores is returned negative--that no
anthrax spores are detected. Please explain your position in this
regard, with as much specificity as you are able.
Response. Although CDC does not ``certify'' in a regulatory sense
that a building is safe, we agree with the stated position. After
remediation, when we are asked to consult, as in the Hart Building, we
will review the pre- and post-remediation sampling strategy and
results. We will consider the Hart Building safe for re-occupancy when
appropriate remediation has occurred and when a rigorous sampling
strategy shows no detectable spores. It must be noted, however, that
sampling cannot ever evaluate every surface in a building and we can
never say that every spore has been killed.
Question 3. With respect to your answer to the preceding question,
please provide copies of all standards or protocols that have been
developed.
Response. Our position regarding the interpretation of post-
remediation samples represents what CDC believes to be good industrial
hygiene practice, but is not explicitly stated in a published document
on anthrax remediation. As noted in our answer to question No. 1 above,
we have published protocols for sampling, for the laboratory analysis
of samples and for the protection of personnel doing sampling and clean
up. They can be found on our web site: www.bt.cdc.gov.
Protection of personnel doing sampling and clean up . . .
http://www.bt.cdc.gov/DocumentsApp/Anthrax/Protective/
Protective.asp
Sampling . . .
http://www.bt.cdc.gov/DocumentsApp/Anthrax/11132001/final42.asp
Laboratory Analysis . . .
http://www.bt.cdc.gov/Agent/Anthrax/LevelAProtocol/
Anthracis20010417.pdf
__________
Statement of Ivan C.A. Walks, M.D., Chief Health Officer, District of
Columbia and Director of Health
Good morning, Chairman Jeffords and distinguished members of the
Committee on the Environment and Public Works. I am Dr. Ivan C.A.
Walks, Chief Health Officer for the District of Columbia and Director
of the Department of Health. With me today is Theodore J. Gordon, Chief
Operating Officer of the Department of Health (DOH), and key staff
members involved with the remediation of biologically and chemically
contaminated buildings. We appreciate the opportunity to testify and
commend you for convening this Hearing because the discussion here this
morning further complements our effort to illuminate the issues
regarding environmental exposures to contaminants in the District of
Columbia.
This hearing also enhances our effort to continuously inform the
community and involve them in decisions or procedures designed to
address their concerns. As I mentioned in the Hearing on Spring Valley
before the House of Representatives in July 2001, we cannot
overemphasize the importance of an ongoing interaction between the
District of Columbia Government and the members of the community. There
can be no substitute for an informed community. That theme has been and
will continue to be a guiding light for our efforts in every community
in the District of Columbia, and in any other effort to prevent
disease, dysfunction and premature death.
Allow me now to turn to the purpose of this hearing, i.e., the
process that the District of Columbia Government is guided by in
remediating biologically and chemically contaminated buildings and its
progress and successes to date. My testimony will also cover the
challenges that confront the District and the rest of the country, the
new technologies available, and our next steps.
The DOH's Environmental Health Administration is charged with the
mission of protecting human health via the prevention and control of
environmentally related diseases, the prevention of environmental
degradation, and the promotion and preservation of the ecological
system and physical environment of the District of Columbia. When
carrying out this charge, it is imperative that we follow a process
that is structured, but at the same time flexible enough to allow for
input from the various stakeholders. In this regard, and particularly
with regard to time-critical remediations, our process is similar to
that described by the U.S. Environmental Protection Agency's
``Superfund Community Involvement Handbook.''
district's process of remediation
The first step toward remediation that we take is to identify/
define the problem. Regarding biological contamination, this step
involves both the identification of contaminated regions of a building
and all the possible pathways by which contamination can move beyond
the contaminated zone to other locations within the building.
We then begin to explore the various remediation options. Each
option is evaluated with regard to its technical effectiveness,
practical feasibility, and the unintended health and ecological risks
to remediation workers and the adjacent community. In other words, we
perform an environmental risk assessment identifying issues and the
problems or risks associated with each option.
In conducting an environmental risk assessment, several things are
considered. First, we must be confident that we will achieve a
successful outcome. Also with regard to each option, we also have to
consider cost, exposure to the government, community hardship
(emotional and physical), and length of time for the cleanup. We
continue to monitor and re-evaluate throughout the planning and
implementation stages of the process.
From this, a prime option is then identified. We also develop a
secondary or ``fall back'' option so that we do not have to restart
from the beginning if the prime option is not selected.
Once we are almost certain that we have considered all pertinent
factors, we then prepare to take a plan of action to the affected
stakeholders for input and ``buy in.'' We have learned a long time ago
that there is no such thing as a successful plan, if the community has
not had the opportunity to participate in it. Again, a big reason for
our success in the Spring Valley community had to do with the inclusion
of that community in our remediation strategy. We have had several
meetings in the community briefing its residents on our findings and
process for remediating. In addition, Mayor Anthony Williams assembled
an independent group, the Spring Valley Scientific Advisory Panel,
which includes seven specialists in the fields of epidemiology,
toxicology and environmental health, as well as two representatives
from the Spring Valley community.
The DOH has had significant experience in remediating biologically
and chemically contaminated buildings in the District of Columbia.
Within the most recent 18 months we have experienced Legionella
contamination in a correctional facility, a public school, and in a
health care facility. We have had significant fungal contamination of
private homes and a public high school following a flood this past
summer. In one community, private homes and a District building were
affected by a petroleum spill. Our successes are largely attributable
to how well we communicate with the affected parties. Of course, we
have a highly skilled and professional group of scientists and
engineers who perform the technical risk assessment and remediation
steps discussed above. However, I continue to stress the importance of
communication as a key ingredient in any successful remediation plan.
challenges confronting the district of columbia and the country
The particular challenge confronting the DOH in the District of
Columbia and all health departments across the Nation regarding
biological decontamination of buildings is that the these remediations
necessarily must take place in a context of emerging science. We are
all traveling steep learning curves with regard to the technical and
medical facts. When we use toxic chemicals to kill biological agents,
the scope of that learning curve includes stakeholders both within and
adjacent to the affected building.
In this regard, we wish to recommend one fundamental public health
principle: until we learn whether a clinically significant minimum
microbial contamination level exists, we should only declare a building
to have been decontaminated when all test samples achieve ``no
detection'' levels. With regard to community exposure to toxic
chemicals we should continue to maintain substantial margins of safety
with regard to exposures to people in the adjacent communities.
next steps
As we proceed to climb these learning curves, we need to share
information with other State and local health agencies. Such
information will include biological sampling protocols, dosing,
measuring, critical bio-load levels and most of all, effectiveness
data. We should expect the emergence of new chemical decontamination
methods, rapid measuring technologies, and biological detection
methods. Knowledge of their efficacies and protocols should be widely
shared within the public health community.
Thank you for this opportunity to come before you to discuss this
issue. We are happy to answer any questions you may have.
__________
Statement of Mike Grosser, U.S. Marine Corps, Technical Director,
Program Manager, Nuclear, Biological and Chemical Defense Systems,
Marine Corps Systems Command
Mr. Chairman and members of the committee, I am Mr. Mike Grosser,
the Technical Director for the Program Manager, Nuclear, Biological and
Chemical Defense Systems, Marine Corps Systems Command, Quantico, VA. I
am pleased to appear before you today to discuss several
decontamination technologies that the Marine Corps and the Joint
Chemical and Biological Defense community have been developing and
supporting. I am responsible to the Program Manager for the oversight
of these programs and I have knowledge of the origin, progress and
current status of each.
The Marine Corps has pursued these technologies as possible
solutions to the requirement for an environmentally benign, patient-
friendly and effective personnel and equipment decontaminant. We did
not set out to identify a specific decontaminant for anthrax-
contaminated buildings. The technologies that I will talk about are by
and large still in research and development. They have been, and in
fact still are considered as candidates for the Joint Service Family of
Decontaminating Systems Program and may be designated as more
appropriate for use by the first or secondary responders, that is, a
municipal firefighter or a unit such as the Marine Corps Chemical-
Biological Incident Response Force (CBIRF), than the traditional
warfighter. While it is possible that one or two of them may be made
available quickly, each has some facet that still requires funding,
research, testing or evaluation. I will describe four decontamination
technologies.
The first technology, Electrochemical Activated Solution, or
ECASOL, was developed in 1972 in Russia to control oil well biofilms.
It is now used commercially in Russia, Japan, South Africa and the
United Kingdom where it is used for home drinking water purification
units (300,000 units sold) and as a hospital biocide such as patient
decontamination, surface decontamination, surgical device
sterilization, wastewater treatment and is also used for reducing
pathogens in food processing operations (e.g. meat and poultry). ECASOL
was used to purify drinking water in Rwanda during the refugee crisis
in 1994-1995.
ECASOL is a colorless, odorless aqueous solution made onsite using
point-of-use electrolysis of diluted brine. The brine is exposed to a
mild electrical charge as it passes through a patented Flow-through
Electrolytic Module (FEM), a 10'' by 1'' diameter tubular device that
converts the brine into a stream of reactive oxidants. A key benefit of
the ECASOL technology is that the oxidant composition can be precisely
controlled over a wide pH range. pH is a measure of the acidity or
alkalinity of a solution. A pH level of 1 is acidic, and a pH level of
14 is an alkaline. For personnel decontamination, skin contact requires
a near neutral pH. At neutral pH (pH 7) the primary oxidant in ECASOL
is the metastable compound hypochlorous acid. This acid, though safe to
skin, eyes and wounds (pH 7), is an effective biocidal agent. The
primary military personnel decontaminant for medical application is 0.5
percent HTH (bleach) which has a pH of 12, is irritating to the skin
and not safe for eyes or wounds.
The Marine Corps began testing ECASOL in 1998 to assess safety,
efficacy and the potential to scale-up field units for use with first
or secondary response personnel. Tests were designed to compare
ECASOL's efficacy versus 0.5 percent (5,000 ppm) bleach at destroying
biological and chemical agents.
Some chemical testing has been conducted but the results were not
as promising as those obtained during biological agent tests.
Before 1998 the largest ECASOL unit was an 80 FEM (400 Gallon per
hour) unit used in a poultry processing plant. Based on the above test
results the Marine Corps built a 600-gallon per hour prototype
generator to evaluate the potential for use by first response units in
personnel showers. All volume generation targets and solution
parameters were met or exceeded during field trials of that unit.
Although ECASOL is generated onsite at the point of use, shelf-life
or storage characteristics were examined. ECASOL solutions stored in
sealed containers for 7 weeks were found to perform almost as
effectively as freshly generated solutions. Solution parameters of pH,
free chlorine and oxidation-reduction potential showed some
deterioration (<10 percent), although overall performance was
maintained. Again, while this information is important, the intent of
the technology is to produce the decontaminant on site.
Further evaluation is required to identify maximum and minimum
effective concentration ranges, effective pH range, efficacy against
Toxic Industrial Chemicals and Toxic Industrial Materials (TIC/TIM),
evaluation as an aerosol (fog), and potential for decontaminating waste
runoff.
Materials and components required to generate the ECASOL are salt
and water (or brine, seawater), electricity and a device containing
FEMs.
ECASOL effluent is environmentally benign and can be drained into a
municipality's sewer system (demonstrated in Atlanta, GA and Camp
Lejeune, NC).
To summarize, ECASOL is a highly effective biocidal agent. It has a
major advantage over 0.5 percent bleach because it has a neutral pH (7)
and is safe for eyes, wounds and skin whereas bleach has a pH of 12,
irritates skin and is not safe for eyes or wounds. Although the
technology works with aqueous solutions ranging from saturated brine
(for producing chlorine) or just plain water (for water purification)
in dilute solutions (as examined here) it is safe yet effective. The
technology is flexible and has been demonstrated in large scale (600
gallons per hour) as well as small scale (5 gallons per hour)
applications.
The ECASOL device developed for testing by the Marine Corps could
be utilized to conduct the test for room/building decontamination proof
of principle. To produce additional prototypes would require purchase
of some custom made long lead items and manufacturing. Three additional
prototypes could be functional and delivered in approximately 120 days.
In the interim, the existing device is capable of producing 600 gallons
of product per hour. A comprehensive test plan has already been
developed for additional efficacy testing (chemical and biological)
that will include additional live agent testing.
The second promising technology is electrostatic decontamination
(ESD) currently under development at the University of Missouri in
Columbia, MO. This research and development program was started in
1998.
ESD is an electrostatically charged mist containing a proprietary
photosensitizer that is sprayed onto a contaminated surface, victim or
a wound. The photosensitizer consists of a hydrogen peroxide base (1-2
percent), a proprietary additive, and a surfactant. The photosensitizer
is then illuminated with a pulsed ultraviolet (UV) light source that
activates the photosensitizer destroying all biological agents present.
System efficacy against chemical agents is unknown as no tests have
been completed at this time. The photosensitizer mist is harmless and
will not cause damage or injury to humans or the environment. The
pulsed UV light wavelength is used for only 4 to 60 seconds and is not
harmful to humans. Eye protection can be provided by regular glasses or
by simply closing your eyes. The system operates in ambient conditions
from temperatures ranging from freezing to 120+ F and
provides open-air sterilization.
Testing revealed the following destruction times:
Photosensitizer + Pulsed UV light:
Anthrax spores, 75 seconds;
E. coli bacteria, 75 seconds;
Salmonella, 75 seconds;
Water borne virus simulants, 75 seconds.
Photosensitizer only--No Pulsed UV light:
Anthrax spores, 8 minutes;
E. coli bacteria, 8 minutes;
Salmonella, 8 minutes;
Water borne virus simulants, 8 minutes.
These results are based on using twice the density of spores
required by NATO standards.
The ESD system is comprised of four major elements:
1. Proprietary photosensitizer-hydrogen peroxide solution,
2. Spray applicator,
3. Ultraviolet light source, and
4. Water
All of these elements are commercial-off-the-shelf (COTS) items
with the exception of the proprietary photosensitizer. The shelf life
of the photosensitizer is 1 to 3 years depending on the purity of the
hydrogen peroxide used. Application of the mist shows coverage of 100
m2/10 liters in 9 minutes. I'd like to note that it has not
been developed or evaluated as a room or ductwork decontaminant, but
rather as a surface decontaminant; we believe that ESD can be misted
into enclosed spaces or ductwork to effectively neutralize biological
agents.
This developmental effort would require some minor modification of
COTS applicators, and testing to ensure proper procedures are in place
to maximize agent neutralization in a building/ductwork environment.
The effort could be completed in 6-8 months if the appropriate test
facilities are made available.
The third technology is a nanoparticle regime that includes
materials with particle sizes ranging between 1-100 nanometers (1
nanometer = 10-9 meters). Nanoparticles of metal oxides
exhibit extraordinary abilities to react with and thereby destroy
highly toxic substances and chemical warfare agents. Kansas State
University (KSU) and their commercial adjunct firm, Nanoscale
Materials, Incorporated (NMI), have been active since 1995 in
developing metal oxide nanoparticles and defining their applications
with regard to destructive adsorption.
Recently, it was also found that special formulations of these
nanoparticles are active against biological warfare agents such as
spores of Bacillus globigii, which is a simulant of anthrax. With
respect to biological agents, nanoparticles have a positive charge that
enables them to attach to negatively charged bacteria cells or spores.
Once attached to the bacteria or spore the nanoparticle penetrates the
cell walls of bacteria destroying the nucleus. For thick-coated protein
cells of spores, addition of chlorine as a stabilized free radical to
the nanoparticle formulation enhances their ability to penetrate these
cells.
Since August of this year Marine Corps Systems Command has
aggressively pursued this technology for a wide range of
decontamination applications. This project is focused on developing
novel dry powder decontamination technologies capable of neutralizing
chemical and biological warfare agents. With appropriate funding this
technology could be available for use as a biological decontaminant as
soon as calendar year 2003.
Sandia National Laboratory (SNL) has developed the fourth
technology.
This decontaminant (designated DF-100) is a non-toxic, non-
corrosive aqueous foam with enhanced physical stability for the rapid
mitigation and decontamination of chemical and biological warfare
agents and toxic industrial materials. The foam formulation is based on
a surfactant system to solubolize contaminants and increase reaction
rates with nucleophilic reagents and mild oxidizing agents. The
formulation includes water-soluble polymers to enhance the physical
stability of the foam. Preliminary test results demonstrate very
effective decontamination of chemical and biological threat agent
simulants on contaminated surfaces and in solution. Testing also
indicates that the formulation may be effective as a general
decontaminant on a variety of toxic industrial materials. This
decontamination technology offers the following benefits: (1) a single
decontaminant solution for both chemical and biological threats (2)
rapidly deployable (3) minimal operational and logistics impacts.
Studies conducted on the DF-100 decontaminant to date include
chemical agent decontamination efficacy (post-decon contact and off-gas
vapor hazards), reaction rates, detector compatibility, toxicity,
materials compatibility and biological simulant decon efficacy.
Biological simulants tested to date include anthrax and smallpox
simulants.
Chemical testing revealed that DF-100 destroyed 99-100 percent of
G, V and H class agents in 10-60 minutes. Biological testing revealed
that DF-100 was effective in reducing biological simulants to a safe
level. Of particular interest, in a 10E6 challenge (1M spores) using
Bacillus globigii (Anthrax Simulants), SNL Foam achieved a 6-log
reduction (reduced to 1 spore or less) within 15 minutes. Other
simulants tested included smallpox and E. Coli MS2 with similar
results.
Material characteristics include a pH of 9.8 and a liquid to foam
expansion of 15:1.
Currently two companies are licensed to manufacture and produce DF-
100. These companies also manufacture or are licensed to sell
application systems capable of dispensing DF-100. These application
systems range in size from man-portable (back pack system) to truck
mounted. Included in these application systems is the Marine Corps
Compressed Air Foam System (CAFSM), a HMMWV mounted fire fighting
system.
Discussion with industry indicates that manufacturing facilities
are capable of producing up to 20,000 gallons per day of DF-100.
Production/delivery capabilities for application systems range from
1000 per month for small systems to 20 per month for large systems.
Decontamination demonstrations at Dugway Proving Ground and Fort
Leonard Wood have shown that DF-100 may be applied with currently
fielded decontamination systems or dual use systems i.e. firefighting
systems, pressure washers.
Preliminary evaluations and studies conducted on SNL DF-100 under
the Joint Service Family of Decontamination Systems program were
designed against tactical operational requirements. SNL DF-100 has not
been evaluated for room or interior decontamination under the JSFDS
program to date.
In conclusion, Mr. Chairman, I want to thank the committee for
inviting me to present this information. This is a vitally important
issue to the Marine Corps and to our Homeland Defense. The Marine Corps
and the Joint Chemical-Biological Defense Program continue to conduct
research, development and acquisition of these and other technologies
with the sole intent of providing Marines and other service members
with the very best capability. I will be happy to address any questions
at this time.
__________
Statement of Les C. Vinney, President and CEO, STERIS Corporation
Mr. Chairman and members of the committee, good morning. My name is
Les Vinney. I am president and chief executive officer of STERIS
Corporation. I thank you for your invitation and welcome the
opportunity to address this critically important issue given the
unprecedented challenge that we face as a Nation.
I am accompanied this morning by Dr. Peter Burke, STERIS vice
president and chief technology officer, and Mr. Gerry Reis, STERIS
senior vice president, Corporate Administration. Also joining me is Ms.
Karla Perri, senior environmental consultant of Versar, Inc.
STERIS Corporation has $800 million in revenues and is a New York
Stock Exchange publicly traded company. STERIS technologies are used
every day in environments where the highest levels of sterility are
required. Healthcare professionals in virtually all hospitals across
the United States, and scientists and researchers in the pharmaceutical
industry--including the Fortune 50 pharmaceutical companies--use STERIS
products to sterilize and decontaminate items, from surgical
instruments to their equipment and facilities. These technologies help
ensure positive outcomes of such critical activities as the production
of antibiotics, the development of vaccines, and the safety of
sensitive medical devices and implants for human beings.
In its simplest form, the primary business focus of STERIS is to
develop and produce formulations that prevent infection and
contamination, and the delivery systems to enable their most efficient
use. When properly utilized, these technologies can provide safe and
effective remediation of contaminated materials in whatever form they
may take, including entire rooms and their various contents. These
technologies can also be put in place to prevent recontamination and
assure ongoing safety, just as is their purpose in the industries we
currently serve.
In light of recent events in our country, we welcome the
opportunity to offer our experience to help prevent infection and
contamination, and to clean and restore biologically contaminated
facilities for normal use. Our persistence in offering our technologies
for these applications is driven by the belief that our technologies
can help to optimize and improve the safety of the current remediation
efforts, both in their application and potential residual effects.
Toward that end, we have joined with Versar, Inc., a leader in
providing counterterrorism, environmental, architectural, engineering
and related services. Together, STERIS and Versar offer a broad array
of contamination risk assessment and remediation services.
Mr. Chairman, we firmly believe that methods now in use in
healthcare and scientific settings can effectively decontaminate
facilities infected with anthrax. The reason that you have not
previously seen us before your committee is that the large majority of
STERIS products are traditionally used in hospitals and by
pharmaceutical companies. As such, we normally have had our
technologies and processes accepted for use under the purview of the
Food and Drug Administration.
While many of our formulations have been registered for specific
uses with the Environmental Protection Agency, our decontamination
processes have not previously been registered for specific
applications, such as mail and building decontamination, of the kind
our Nation is now addressing.
Since the initial anthrax contamination events, we have had
numerous meetings with officials on Capitol Hill and in various Federal
agencies to discuss the possible uses for our products and services.
While our past experience gives us very high confidence in the
effectiveness of our technologies, we strongly endorse the regulatory
requirements to test and validate a product technology prior to
allowing its use in specific treatment applications.
In that regard, we have been seeking the opportunity to demonstrate
the efficacy of our product technologies to meet various remediation
needs--and allow people to safely return to their work environment. We
hope a bridge can be created across regulatory jurisdictions to enable
the more rapid application of these existing capabilities to meet
emergency decontamination needs.
We are now working closely with the EPA in the attempt to secure
the necessary approvals to permit the use of these available
applications. We are also in advanced discussions with the Department
of Justice on a potential demonstration project, which would serve to
validate the effectiveness of these technologies in decontaminating
anthrax infected facilities.
In recent years, hazardous materials decontamination efforts have
largely focused on remediation of contaminated water and soil.
Buildings contaminated with anthrax present an unprecedented challenge.
Effective remediation requires multiple technologies to deal with
both microbial and biochemical contaminants.
The healthcare and pharmaceutical industries have dealt with
microbial control challenges for many years. As a result, highly
sophisticated prevention and treatment methodologies have been
developed within these industries. While older technologies such as
formaldehyde and chlorine dioxide have, in fact, been used in these
industries, newer technologies, such as vapor hydrogen peroxide and the
combination of hydrogen peroxide and peracetic acid sporicidal
compounds, have been developed. These emerging technologies have
displaced the earlier technologies because they offer reduced toxicity,
limited corrosiveness, minimal residual effects, and easier
application.
A facility contaminated by highly aerosolized anthrax spores, which
have been distributed to remote areas due to cross-contamination during
mail delivery or through ventilation systems, involves a unique and
severe challenge. While these conditions present a different
environment than our more standard applications, we believe our
technologies can be applied to the remediation and elimination of
contaminants in this type of setting, as well.
To accomplish proper remediation, a carefully planned process
similar to the Hazard Analysis and Critical Control Point approach
would be used, just as is currently done in establishing the preventive
process for healthcare and scientific requirements. In an appendix
attached to my written testimony we have presented a detailed plan for
systematic biological remediation of a given facility or area.
For any remediation effort, STERIS working with Versar recommends a
series of steps to render a contaminated area safe for use. These
include mapping the extent of contamination, reviewing the area and its
contents, decontaminating using a combination of technologies and
methods, confirming effectiveness and documentation.
It is also important to note that the length of any remediation
process will depend on the scope of the project--including the level of
contamination--and size of the building. All of the proper biological
indicators and others tests must be completed before employees can be
allowed to return to a building.
Mr. Chairman and members of the committee, in our professional view
there is no single silver bullet for treating chemical or biological
contamination. This remediation requires the selective use of multiple
technologies, not reliance on a single treatment type. This approach
should result in the least damage to items within contaminated
facilities, assure that each surface and material is treated with the
agent best suited to its individual needs and provide the highest level
of decontamination.
In closing, we believe a coordinated effort is needed among the
appropriate government, academic, military and private industry
officials. This coordinated approach will permit the identification,
validation and utilization of the safest and most effective
technologies currently available. Careful development of the proper
protocols for this remediation process is critical to a successful
outcome. What we must achieve is the restoration and maintenance of
safe working environments for all Americans. STERIS stands ready to
help.
Thank you for the opportunity to appear before you today. I would
be happy to answer any questions you may have.
______
APPENDIX A
STERIS Corporation Overview
STERIS Corporation is a leading provider of infection prevention,
contamination prevention, and microbial reduction products, services,
and technologies to healthcare, scientific, research, food, and
industrial customers throughout the world. Founded in 1987, and
expanded with a series of acquisitions of companies with over 100 years
of service, STERIS has been at the forefront of meeting customers'
needs to prevent infection and contamination, contain costs, and
improve efficiencies. STERIS products can be found wherever there is a
need to ensure the highest levels of sterility.
Headquartered in Mentor, Ohio, the Company has 4,500 employees,
with production and manufacturing operations in 14 States plus Puerto
Rico, Canada, Finland and Germany. The Company has sales offices
located in 17 countries. STERIS has annual sales of over $800 million,
and its stock is traded on the New York Stock Exchange under the symbol
STE.
STERIS customers include more than 5000 hospitals, Fortune 50
pharmaceutical companies, and many leading medical device
manufacturers. The Company's broad array of infection and contamination
prevention products and services are used every day by healthcare
professionals, scientists and researchers to ensure that materials and
surfaces are free of contamination and safe for human contact. STERIS
technologies are also used to decontaminate critical environments such
as clean rooms, isolators, and research work areas.
STERIS professionals are committed to understanding the needs of
each individual customer and customizing the application of the
Company's technologies to ensure positive outcomes of such critical
activities as the production and manufacture of medicines to prevent
and cure disease, to eliminate the risk of infection during surgical
procedures, and to ensure that sensitive medical devices and implants
are safe for use on human beings.
The Company is committed to the development of new technologies as
well as the discovery of new applications of existing technologies, to
serve the infection and contamination needs of its customers. The
Company's core technologies and services include:
High and low temperature sterilization systems utilizing
steam, ethylene oxide, vaporized hydrogen peroxide, and paracetic acid
based technologies.
Contract sterilization services provided through a network
of 16 facilities in North America offering gamma irradiation, electron
beam and ethylene oxide sterilization technologies.
Surface disinfectants and liquid cold sterilants
formulated to disinfect and sterilize hard surfaces.
Personnel hand wash and rinse products that are used to
keep hands free of bacteria.
Surgical support products and services that enable
healthcare professionals to provide the highest levels of patient care.
Automated washing/decontamination systems and related
detergent and cleaning chemistries.
Facility planning and design services.
Contamination risk assessment and remediation services.
Education, training, installation and repair services.
______
APPENDIX B
Detailed Biological Remediation Plan
executive summary
Let us briefly consider the technologies that are available and our
objectives in their use. These antimicrobial technologies should be
rapidly effective at killing bacterial spores, which of all
microorganisms are accepted as the most difficult to kill. Further,
they should have minimum safety hazards, not damage the room or its
important contents, and if possible be widely used and accepted for
decontamination.
First, certain room contents including rugs, drapes, personal
items, and electronic equipment may need to be removed and
decontaminated separately from the room. STERIS recommends that these
can be batch sterilized by widely used methods including ethylene oxide
or irradiation. It may be also prudent to consider the overall cost of
remediating these items compared to the alternative of removing,
appropriately disposing and replacing them.
Technologies available to decontaminate rooms may be divided into
two categories: liquid and gaseous.
A variety of liquid and foam-based technologies are available. In
general, most routinely used disinfectants in households and hospitals
demonstrate relatively slow or indeed no activity against bacterial
spores. For example, high concentrations of chlorine solutions (like
household bleach) are not recommended due to limited activity against
spores and damage to surfaces. STERIS recommends the use of EPA-
registered sporicidal products that are currently used for this purpose
in high-risk or regulated areas, which have past rigorous, standardized
tests and have demonstrated material compatibility.
Overall, liquids or foams are excellent for small surface
application, but are difficult to ensure coverage and effectiveness
over larger areas (including walls and ceilings). They also require
significant time for application and cleanup, and will not be practical
for certain surfaces, including electrical equipment.
Gaseous or vapor technologies are recommended for rooms. The most
widely used are formaldehyde and Vaporized Hydrogen Peroxide (VHP).
Formaldehyde is less used today due to variable efficacy and
significant health and safety concerns. VHP has been widely used and
accepted as a safe alternative. This dry process has been used for over
10 years in the pharmaceutical industry for room decontamination and
has been validated for use in a government facility for anthrax
decontamination. A simple, mobile VHP system generates, supplies,
controls and neutralizes the dry vapor into a given area in one stand-
alone process. A low concentration of vapor is required to rapidly kill
spores, but is also very compatible with surfaces, including
electronics and painted surfaces. This technology is one of the safest
and an equally effective method for room decontamination.
detailed analysis
STERIS recommends that HACCP (Hazard Analysis and Critical Control
Point) principles should be applied, since in our opinion no single
intervention to this situation will be adequate to reduce the risk 100
percent. The basis of HACCP is to identify and to conduct a hazard (or
risk) analysis, identify critical control points and introduce controls
(or interventions) at these points to reduce contamination from
Bacillus anthracis. It is further clear that no single technology is
applicable or capable of complete decontamination in every area, but
combining technologies and products that have been widely used,
registered and accepted for similar applications in other environments
should be adopted. A logical series of steps can be taken to maximize
the decontamination process:
Buildings should be sealed and contamination mapped. High
and low risk areas should be identified and interventions (either
single or multiple) conducted to reduce infection risks associated with
each area.
A combination of methods employed for decontamination:
HEPA vacuuming or surface liquid treatment (this in
many cases may be sufficient, depending on the level and scope
of contamination)
Boxing up of absorptive materials in heavily
contaminated rooms and sterilizing by irradiation, ethylene
oxide or terminal destruction.
Preparation of area for decontamination and any
pretreatment with liquid sporicidal agents.
Products used should have demonstrated (and registered) broad-
spectrum antimicrobial activity on a surface as well as material
compatibility.
Room fumigation with sporicidal, registered and
material compatible process. This may be alone suitable as a
preventative measure in room with low or suspected no
contamination where surface decontamination of room contents
may be sufficient depending on the determined risk.
Verification of process effectiveness by process
monitoring and documentation
Retesting for contamination following decontamination
to confirm effectiveness.
In general, the remediation plans that are under discussion for
anthrax-contaminated buildings do adopt HACCP principles, identifying
the overall problem and recommending potential methods of remediation.
However, the plan appears to critically rely on chlorine dioxide
(ClO2) gas as the primary disinfecting/sporicidal agent to
decontaminate the building, as well as manual treatment with some foams
and liquids, but relying in particularly on chlorine dioxide and
concentrated bleach solutions. A number of alternative registered
products that have been widely used for similar applications do not
appear to have been considered for remediation of biologically
contaminated buildings. A review of the remediation plan and products
that could be used are discussed below.
It is important to note that bacterial spores, such as Bacillus
anthracis spores, are traditionally considered the hardest of all
microorganisms to kill. These spores are significantly more resistant
than normal bacteria, viruses and fungi, and are difficult to eradicate
using standard disinfection or decontamination methods. Therefore, in
cases of contamination with anthrax spores, decontamination methods are
required to show rapid and consistent sporicidal activity, but also
compatibility with the surfaces being treated. Although a variety of
simple microbiological methods may be used to indicate the possible
effectiveness of a given product against bacterial spores, a specific
registration is required in the United States. Any liquid, vapor or gas
product that is registered with the EPA has shown effectiveness
relative to a rigorous, standardized test, namely the AOAC
International Sporicidal method. EPA registered and widely used
sporicidal products should be considered first for decontamination
against anthrax spores.
Overall no single method will be effective for all contaminated
areas. In some cases, certain room contents may not be compatible with,
may not be adequately decontaminated or may even inhibit the
effectiveness of the decontamination method. These items may include
rugs, drapes, personal items, electronic equipment and paper, depending
on the decontamination method used. It is recommended that these items
have specific treatment plans to assure sporicidal effects. In some
instances treatment in place with certain gaseous products is
appropriate, while external treatment of other items should be
employed. Batch sterilization of isolated items can be performed by
widely used methods including ethylene oxide or irradiation, and
returned to the room. Alternatively, following decontamination certain
items may be destroyed by incineration. It may be also prudent to
consider the overall cost of remediating these items compared to the
alternative of removing, appropriately destroying, disposing and
replacing them.
STERIS offers more than 28 years of sterilization experience and 16
sites throughout North America for irradiation and ETO sterilization.
These facilities have processed more than 60 million cubic feet of
product in the last 12 months, including medical supplies,
pharmaceuticals, food containers, spices and cosmetics.
Irradiation is the process of exposing a product or material to
ionizing radiation. Ionizing radiation is energy that exists in the
form of waves and is defined by its wavelength. As the wavelength of
energy gets shorter, the energy increases. Radiation destroys
microorganisms by breaking chemical bonds in biologically important
molecules such as DNA, and by creating free radicals and reactive
molecules, which chemically attack the microorganism. Irradiation is
not the same as radioactive. Many consumer products are sanitized,
sterilized or modified by irradiation of the materials. Irradiation
methods, their antimicrobial efficacy and applications are widely
accepted and used for contract sterilization of wrapped and/or packaged
materials and products, including medical devices and foods.
Ethylene oxide (ETO) is a colorless gas, which is used for the low
temperature sterilization. Developed in the 1940's and 1950's, ETO is
the primary gas used in hospitals to sterilize reusable items (e.g.
medical devices that contain plastics) that cannot tolerate high
sterilization temperatures. In addition, ETO sterilization is used for
contract sterilization of medical, dental or veterinary devices that
are delivered sterile to a consumer which are sensitive to steam
sterilization or that contain materials incompatible with irradiation
sterilization. The properties and broad-spectrum antimicrobial activity
of ETO have been well described in the literature.
Technologies available to decontaminate potentially biological
contaminated rooms, enclosed areas, HVAC ductwork, fixed and mobile
equipment, and general hard surfaces may be divided into two
categories: liquid and gaseous.
Liquid based technologies include a variety of products, which
include liquids and foams. In general, most routinely used
disinfectants in households and hospitals demonstrate relatively slow
or no activity against bacterial spores. Products that are generally
not effective include phenols and quaternary ammonium compound-based
products. Sodium hypochlorite solutions (commonly referred to as
`bleach' or `chlorine') can be effective but the following points need
to be taken into consideration. At high concentrations, bleach will
demonstrate some activity against spores; however, it requires long
contact times, for example, purified spores placed directly into
freshly prepared 10 percent bleach for 15-20 minutes will give an
average 3-log reduction of spores. The effectiveness of bleach is
dramatically reduced by interfering surfaces and organic soils, which
also interact with the available chlorine. Furthermore, to our
knowledge bleach is not a registered sporicide with the U.S. EPA. A
further concern, which is familiar to all of us, is compatibility with
room materials and surfaces; bleach, like other chlorine-based products
can be damaging and even destructive to a variety of surfaces. Bleach
can be effective over extended exposure times but only on clean,
compatible surfaces.
A variety of other alternative liquid or foam formulations can also
be recommended and maybe more applicable. These include oxidizing-agent
based formulations, including liquid hydrogen peroxide, peracetic acid,
chlorine dioxide or combinations thereof. We propose that any of these
products, with demonstrated activity against a wide range of
microorganisms, including bacterial spores, demonstrated material
compatibility, reasonable safety and worker health profile, and, if
possible, experience of use outside of a laboratory setting can be used
for decontamination of anthrax. An example of an EPA-registered
sporicidal product is SPOR-KLENZ, which is a liquid, synergistic
combination of hydrogen peroxide and peracetic acid, which is widely
used and validated for use in the pharmaceutical industry for its rapid
spore killing activity. A complete dossier of publications,
pharmaceutical applications, case studies, safety and user references
are available.
There are also registered chlorine dioxide-based products, but in
general these may be more damaging on surfaces. Certain foam or
nanoemulsions have also been recommended. In comparison, these products
require significantly longer contact times, have not been widely used
and should also pass the required rigorous antimicrobial testing and
safety profile for EPA registration.
Liquid or foam based products do have some major limitations. The
most obvious is ensuring correct application of the product over all
contact surfaces, including walls, floors, ceilings and room contents
for the required decontamination time. For example, these products are
not practical for HVAC ductwork. Following decontamination, the product
also needs to be removed and dried prior to normal use. Additionally,
surface compatibility with liquid or foam-based products varies
depending on the product. Of greatest concern is the use of `wet'
methods relative to electrical equipment (including phones and
computers), as well as other sensitive surfaces. In general, these
products are not used or reliable for large, uncontrolled surface
areas.
Gas or vapor-based technologies can also be considered, which
possess acceptable registered spore killing activity, material
compatibility, and safety/worker health profile. A summary of the
advantages and disadvantages of these methods is attached in Table 1.
The most widely used methods for this purpose are formaldehyde and
Vaporized Hydrogen Peroxide (which is referred to as VHP). Formaldehyde
has been traditionally used for over 100 years, although less
frequently today due to variable efficacy and significant health and
safety concerns. Formaldehyde is extremely toxic and carcinogenic.
Further it leaves a white residue on all surfaces following the
decontamination process, which is toxic and needs to be adequately
removed prior to occupancy. From an effectiveness point of view,
decontamination is relatively uncontrolled and usually takes up to 36
hours for completion. Of greatest significance is the fact that these
rooms need to be humidified before and during treatment.
For these reasons, VHP has been used as an effective alternative.
The VHP process is a rapid, dry, controlled technology using a low
concentration of hydrogen peroxide vapor. Unlike liquid hydrogen
peroxide, VHP is rapidly sporicidal at low concentrations and has been
widely used as a validated process for over 10 years for room and
enclosure decontamination. For example, the process is routinely
validated for decontamination of rooms and enclosures using bacterial
spores, and in certain selected cases against anthrax spores, to
confirm process effectiveness. A simple, mobile system generates,
supplies, controls and removes VHP from a given environment in a one
step process, which can be monitored, verified and documented. Being a
`dry' method, the process demonstrates excellent compatibility with a
wide range of materials, including paint and electrical equipment like
computers. The VHP process is the safest method available for vapor/gas
decontamination; for example decontamination may proceed in a sealed
room while personnel safely work in adjacent areas and no cleanup is
required following the process. One disadvantage is that the presence
of significant cellulosic-based materials in a given room may elongate
the process time and multiple generators are required to do areas
larger than 7500 ft3. A new high capacity VHP delivery and
control system has recently been developed by STERIS to be available as
soon as possible for large-scale room decontamination. A complete
dossier of publications, pharmaceutical applications, case studies,
safety and user references are appended.
Other technologies that may also be reasonable alternatives to
formaldehyde include chlorine dioxide gas, which has shown good promise
in the laboratory setting. Chlorine dioxide gas is rapidly
antimicrobial but has significant material compatibility concerns. It
is undetermined whether this process has been registered with the EPA,
apart from a special exemption for anthrax decontamination. Like
formaldehyde, significant humidification of a given area is required
for chlorine dioxide gas to be effective in a room, which needs to be
kept in the dark to prevent breakdown. Five hundreds times the
concentration of chlorine dioxide gas is required to be present and
maintained to be sporicidal relative to vapor hydrogen peroxide over a
longer contact period (8 hours vs. 4 hours). Chlorine dioxide gas has a
higher level of safety risks associated with its use and can also leave
a white residue that requires immediate clean-up following
decontamination. These safety risks also apply to its production,
transport and use, as the gas cannot be easily produced onsite. For all
these reasons, chlorine dioxide gas has not widely used or accepted for
this application. Attempts to apply a controlled delivery and removal
process based on chlorine dioxide gas for the decontamination of
cleanrooms was unsuccessful in actual pharmaceutical, controlled
applications.
STERIS has presented a rational, detailed plan for decontaminating
biologically contaminated areas and their contents to render them safe
for human contact. This plan recommends the use of multiple
technologies for this purpose and recommends the use of EPA-registered
products, which have been widely used for many years and remain the
safest, effective and most practical methods available for room
decontamination.
Table 1.--Comparison of Room Decontamination Methods
----------------------------------------------------------------------------------------------------------------
Gaseous chlorine
Fogging/foaming Formaldehyde dioxide VHP
----------------------------------------------------------------------------------------------------------------
Variable coverage and distribution... Variable coverage and Depending on mode of Controlled delivery
distribution. delivery, more system for more
reliable distribution. reliable distribution.
Difficult to maintain Kinetics of
in gaseous state; can maintaining gaseous
condense. state is understood
and important for
process effectiveness.
Wet methods.......................... Requires significant Requires significant Dry sterilization
hydration for hydration for method
antimicrobial antimicrobial
efficacy. Essentially efficacy. Essentially
wet process. wet process.
High concentrations required for High concentrations 500ppm sporicidal over 1-2ppm sporicidal at 25
rapid sporicidal activity. required for rapid 8 hours (but needs to C. 1 log reduction
sporicidal activity. be kept in the dark). every 1-2 minutes.
Difficult to control and deliver over Significant risks and Significant risks and Controlled delivery
large surface areas and ensure difficultly providing difficultly providing contacts all surfaces.
residence time for horizontal to a large area. to a large area. New system available
surfaces. Overall better Overall better for large area
coverage than fogging coverage than fogging fumigation
or foaming. or foaming.
Difficult to validate................ Difficult to validate.. Validation possible. Validation and
Can be biologically documentation
verified. routinely conducted.
Can be parametrically,
biologically and
chemically verified.
Concerns over material compatibility; Can be damaging to Significantly damaging Broad range material
extent dependant on contact time and surfaces. to a variety of compatibility
antimicrobial agent/formulation. surfaces, even after
single exposures.
Concerns already noted
in cleanroom
applications.
Not safe on electrical equipment..... Not safe on electrical Not safe on electrical Safe on electrical
equipment. equipment. equipment
Efficacy inhibited by presence of Stable, difficult to Efficacy inhibited by Efficacy inhibited by
absorbing materials. remove. presence of absorbing presence of absorbing
materials. materials
Occupational risks significant, Significant Occupational risks Occupational risks
dependant on antimicrobial used. occupational and significant, but can minimal. Safest for
safety risks. be minimized. environment and
personnel health
Extended contact times and clean-up Extended contact times Extended contact times Most rapid method and
required. and clean-up required. and possible clean up room ready for use
required. Chlorine directly following
residuals. cycle. No residuals.
Limited registration, depending on Limited registration, Unknown registration Sterilant used in the
antimicrobial.. traditional use. situation with process. process registered
with the EPA
Variable efficacy depending on the Variable efficacy...... Broad spectrum Broad-spectrum
product. antimicrobial activity. antimicrobial
activity, including
independent testing
against and validation
with B. anthracis.
----------------------------------------------------------------------------------------------------------------
______
Responses by Les C. Vinney to Additional Questions from Senator
Jeffords
Question 1. Have you approached EPA about your technologies for
decontamination? If so, what type of response did you receive?
Response. STERIS officials have had numerous meetings with EPA
officials to discuss our technologies for decontamination--and we have
provided all of the documentation requested to validate our
technologies. Among those we have met with are Marianne Horinko,
Assistant Administrator for Solid Waste and Emergency Response, Claudia
McMurry, Chief of Staff to Deputy Administrator Linda Fisher, Carlton
Kempter, Senior Advisor, Antimicrobials Division, Office of Pesticide
Programs, and Rich Ruppert, Site Coordinator for the Hart Building
Remediation.
While many of our products and formulations are registered for
specific uses with the EPA, our decontamination processes have not
previously been registered for specific clean up applications, such as
mail and building decontamination, stemming from the kind of bio-
terrorism events our Nation is now addressing. The large majority of
STERIS products are traditionally used in hospitals and by
pharmaceutical companies. As such, we normally have had our
technologies and processes accepted for use under the purview of the
Food and Drug Administration. As such, the primary purpose of our
meetings with the EPA has been to seek the necessary re-labeling of our
products to allow their use for mail and building decontamination now
taking place under their jurisdiction.
We are working closely with the EPA in an attempt to secure the
necessary approvals to permit the use of these available applications--
and move forward with their use. On December 12, 2001, we provided EPA
with the formal request for specific exemptions clarifying our position
for these STERIS technologies--vaporized hydrogen peroxide (VHP), Spor-
Klenz Peracetic Acid Sterilant and ethylene oxide
sterilization systems. We have previously provided detailed background
data to support this request.
On December 13, 2001, EPA officials contacted STERIS to ask for our
assistance in the remediation of an EPA facility in Northern Virginia.
We are hopeful, based on that request and subsequent conversations, we
are close to receiving the re-labelings that we have requested and will
be able to begin work on mail and building decontamination in the very
near future.
Question 2. Tell us about your VHP technology in terms of its
ability to prevent recontamination.
Response. In high-risk areas like a mailroom, microbial
decontamination can be accomplished by a routine regimen of
disinfection to prevent possible cross-contamination during normal mail
sorting. Unlike many other technologies, vaporized hydrogen peroxide
(VHP) can be used without degradation to hard, non-porous surfaces on a
routine basis for microbial destruction.
VHP technology provides rapid, low-temperature decontamination
methods for any enclosed area that may be contaminated with
microorganisms, including spore-forming bacteria. These systems are
widely used to render surfaces and areas safe for contact. VHP systems
are currently used as rapid, low temperature techniques for
decontamination of producing filling lines, sterility testing
environments, sealable enclosures, and various types of rooms in
hundreds of installations, including pharmaceutical production,
laboratory animal, research and biosafety laboratory facilities.
Further systems are also available to sterilize medical devices. In
all of these situations, VHP technology renders contaminated surfaces
safe for use or contact. There are no residuals or inhibitory chemicals
remaining on a surface following the decontamination. For this reason,
VHP is designed to render a surface safe for use, but when a surface is
recontamined (e.g., if a further anthrax-laced letter was opened in a
given area), the process would have to be repeated in that area to
render it safe for contact. For example, a pharmaceutical clean room
used to manufacture an antibiotic, is routinely decontaminated using
this technology on a weekly or even a daily basis to maintain the area
as clean and sterile.
______
Responses by Les C. Vinney to Additional Questions from Senator Smith
Question 1. Please state, as directly as possible, and with as much
particularity as you are able, any criticisms you have of the decisions
made to date in the remediation process used at the Hart Building.
Response. EPA has never asked STERIS for a formal proposal to
remediate the Hart Building. As a result, we have not had access to the
facility since it has been contaminated--and, therefore, it is
difficult to address the issue with any specifics. However, early on in
the process we met with Secretary of the Senate Jeri Thomson to present
our general suggestions on the Hart Building remediation. As a follow-
up to that meeting, Ms. Thomson provided STERIS with a copy of Proposed
Action Plan for Remediation of the Hart Senate Office Building (HSOB),
Washington, DC (October 31, 2001) and asked for our analysis and
comment. We provided our response on November 5, 2001, and I have
included a complete copy of that document for your review (attached as
Appendix A).
Question 2. In addition to any answer you give to the preceding
question, please state directly your position as to whether VHP would
have been a better choice as a fumigant over chlorine dioxide gas for
use in the Hart Building.
Response. As I outlined in my testimony, the healthcare and
pharmaceutical industries have dealt with microbial control challenges
for many years. As a result, highly sophisticated prevention and
treatment methodologies have been developed within these industries.
While older technologies, including chlorine dioxide and formaldehyde
have, in fact, been used in these industries, newer technologies, such
as STERIS's VHP system, have been developed. The use of formaldehyde
has decreased due to the fact that it is a known human carcinogen, and
the use of chlorine dioxide has likewise decreased due to the very
corrosive nature of the chemical. Therefore, emerging technologies like
VHP have displaced the earlier technologies because they offer reduced
toxicity, limited corrosiveness, minimal residual effects, and easier
application. I would draw your attention to the chart previously
submitted as the final page of my written testimony (attached as
Appendix B)--a comparison of room decontamination methods, including
fogging/foaming, formaldehyde, chlorine dioxide and VHP.
______
APPENDIX A
PRIVATE AND CONFIDENTIAL
November 5, 2001.
Ms. Jeri Thomson, Secretary of the Senate,
U.S. Senate,
Washington, DC.
Dear Ms. Thomson: Thank you for providing us with a draft copy of
the Proposed Action Plan for Remediation of the Hart Senate Office
Building (HSOB) Washington, DC. (October 31, 2001)--and permitting our
analysis and response.
STERIS Corporation has specific questions on the reliance on
chlorine dioxide (ClO2) as the primary agent for
decontamination of the HSOB. The plan is based on the assumption that
ClO2 will have sufficient penetration of items such as
paper, rugs, and drapes. However, we believe there is reason to
question this approach--both from a scientific perspective regarding
the sporicidal effect of the treatment, as well as potential damage to
materials in Senate offices, including fine art. Additionally, the
proposed use of diluted bleach has important limitations with regard to
sporicidal properties, which are not clearly expressed in the document.
Based on our questions, we have attached a detailed three-part
response for your review:
STERIS Corporation comments on the remediation plan
(Tab A);
Comparative tables of the attributes of chlorine
dioxide versus vapor hydrogen peroxide and diluted liquid
bleach relative to EPA-registered sporicidal products (Tab B);
and
An outline of factors in the planned remediation,
with alternate considerations as a reference guide (Tab C).
STERIS Corporation is pleased to present these documents, which
address the critical decontamination needs facing our government. We
look forward to further discussions, and to offering our assistance in
the remediation process.
Sincerely,
Peter A. Burke, Ph.D.,
Chief Technology Officer.
______
APPENDIX A
TAB A
Comments on the Proposed Remediation Plan for the Hart Senate Building
(HSOB)
The Hart Senate Office Building (HSOB) was contaminated on October
11, 2001; with reportedly weapons grade Bacillus anthracis spores in an
envelope. A very concentrated spore population has left significant
contamination in some areas of the building, while other sectors remain
uncontaminated. This organism is projected by the Center for Disease
Control (CDC) to have an Infectious Dose 50 percent (ID50)
of 6,000-10,000 spores and a potential for cutaneous anthrax with as
little as 5-50 spores in animal trials. The ID50 reflects a
normal, healthy population; however, any individuals that are in any
way immunocompromised are more susceptible. Further, the persistence
and potential germination/proliferation of spores under suitable
conditions (e.g. damp air vents) could potentially contaminate further
areas. Hence, a very conservative approach appears to be warranted.
STERIS recommends that HACCP (Hazard Analysis and Critical Control
Point) principles should be applied, since in our opinion no single
intervention to this situation will be adequate to reduce the risk 100
percent. The basis of HACCP is to identify and to conduct a hazard (or
risk) analysis, identify critical control points and introduce controls
(or interventions) at these points to reduce contamination from
Bacillus anthracis. It is further clear that no single technology is
applicable or capable of complete decontamination in every area, but
combining technologies and products that have been widely used,
registered and accepted for similar applications should be adopted.
The remediation plan of the HSOB, as discussed in the public press,
does adopt HACCP principles, identifies the overall problem and
recommends potential methods of remediation. However, the plan appears
to critically rely on chlorine dioxide (ClO2) fumigation as
the primary disinfecting/sporicidal agent to decontaminate the
building.
The major premise of the plan assumes that an overnight residence
time utilizing at least 1000 ppm of chlorine dioxide will significantly
reduce the microbial population without adversely affecting the
furnishings, including artwork and personal effects, in offices. Based
on our experience, STERIS would technically disagree with this
assertion.
It is reasonable to ensure that decontamination of exposed surfaces
will occur with ClO2. ClO2 has been widely used
for disinfection of water, but is considered corrosive as a liquid
surface disinfectant and particularly as a gaseous fumigant.
ClO2 is not widely used as a sporicidal fumigant, although
it is used at low concentrations for odor control. Further, as an
oxidizing agent, the degree of penetration into and efficacy on
absorptive materials, including carpets, drapes, piles of papers,
organic/inorganic soils and filing cabinets, is unknown and probably
limited. It is also important to note that these materials just noted,
due to their active absorption and breakdown of ClO2,
dramatically reduce the level of decontamination in a given area. This
is true for any antimicrobial agent, including oxidizing agents.
It is recommended that the following points be considered for
remediation:
Consideration should be given to treating the rugs,
drapes, personal items, electronic equipment and paper separately.
Rugs--Since the degree of ClO2 penetration is
unclear, perhaps direct treatment with a sporicidal product
would be prudent to reduce hot spots of spores in the carpet
pile. EPA registered rapid sporidical products should be
considered first and used for this purpose. One class of
products that should be considered are those based on peracetic
acid/hydrogen peroxide combinations, in particular, due to the
synergistic modes of action and unique attribute of peracetic
acid to retain its antimicrobial activity in the presence of
significant soil. These products could be directly applied
prior to any gaseous treatment.
Drapes--It will be difficult to directly treat these items;
however, they could be packaged and sent for offsite
irradiation or ethylene oxide sterilization.
Consideration should be given to the overall cost of
remediation of rugs and drapes, and to the alternative of
removing, destroying and replacing these items.
Papers--The heavily contaminated offices should have the
papers irradiated to allow disinfection of all hard surfaces
without impedance. It is important to note that piles or files
of paper may not be adequately penetrated or decontaminated
using the proposed method.
A further concern, if reported correctly, is the use of
bleach (10 percent), which is slowly sporicidal and will be damaging
for many surfaces at the specified contact times. It has been our
experience, using purified spore preparations, that bleach diluted 1:10
shows a 2-3 log reduction of Bacillus spores after 15-20 minutes
contact in a suspension test, which is under best case contact
conditions. More rapid, efficacious and registered products for surface
sporicidal activity are available and could be used.
Chlorine dioxide, while an excellent sanitizing agent of
water, is considered very reactive with organic materials, such as
wood, as well as metals. The items described above, including
paintwork, wood coverings, etc., will most likely be damaged if
fumigated with ClO2. Significant residuals will also remain
on surfaces following fumigation and may require lengthy aeration times
or post-fumigation clean-up.
It is important to note that fumigation with ClO2
requires significant hydration of all surfaces in order to be
effective, which can be further damaging to certain surfaces
due to the risk of condensation (for example, it would not be
applicable with computers or other electronics), elongates the
overall cycle time and is difficult to ensure with large room
volumes. For all these reasons, ClO2 is not widely
used for room decontamination.
The most widely used antimicrobials for this application are
formaldehyde and vaporized hydrogen peroxide (VHP). Both have
been used for many years, with VHP becoming more popular due to
the significant safety and efficacy concerns with the use of
formaldehyde. The pharmaceutical industry has found that VHP is
dry on contact, a rapid sporicidal agent, demonstrates broad
spectrum material compatibility and is safe environmentally, as
well as from a health risk exposure perspective. For example,
hydrogen peroxide vapors have an 8-hour workday exposure of 80
ppm versus 0.1 ppm for ClO2. Also note that in
comparison to 500 ppm sporicidal concentration of
ClO2, VHP is sporicidal at 1-2 ppm at 25+
C. It is important to note that this technology has been widely
recognized and accepted. Major pharmaceutical companies such as
Merck, Baxter, and Pfizer have used VHP technology as an
effective room sterilizing agent for over 10 years. Further,
the sterilant used in the VHP process has been registered with
the EPA now for many years. Decontamination requires no
hydration (in fact rooms are dehumidified to ~40 percent), is
controlled, documented and can be validated parametrically,
biologically and chemically, and is safe for use on a wide
range of sensitive materials, including computers and
electronics. For selected areas that have sensitive equipment
or fine art, this technology may provide the only alternative
with less damaging long-term effects. Additionally, if repeated
treatment is required in highly contaminated areas to ensure
eradication of spores without severe effects, vaporized
hydrogen peroxide would be the fumigant of choice.
Currently, a single VHP delivery system can successfully
decontaminate rooms up to ~7500 ft3--and with
multiple systems in tandem can decontaminate larger areas. A
new, high capacity VHP delivery system has recently been
designed and put on fast track development by STERIS to be
available as soon as possible for larger scale room
decontamination. A complete dossier of publications, successful
application, case studies and user references are available on
request.
We respectfully submit that reliance on a single technology may not
be the most prudent course of action when attempting to significantly
reduce the risk of infection due to this level and nature of
contamination. We propose that independent verification of the
discussions in this document be obtained from known thought leaders in
sterilization and disinfection; for this we recommend Dr. Seymour
Block, Department of Chemical Engineering at the University of Florida,
a recognized expert in this area, as exemplified by being the editor of
five editions of Disinfection, Sterilization, and Preservation.
APPENDIX A
TAB B
Comparison of Antimicrobial Fogging, Chlorine Dioxide and VHP for Room
Decontamination
STERIS Corporation.--Comparison Tables
------------------------------------------------------------------------
Gaseous chlorine
Fogging/foaming dioxide VHP
------------------------------------------------------------------------
Variable coverage and Depending on mode Controlled
distribution. of delivery, more delivery system
reliable for more reliable
distribution. distribution.
Difficult to Kinetics of
maintain in maintaining
gaseous state; gaseous state is
can condense. understood and
important for
process
effectiveness.
Wet methods..................... Requires Dry sterilization
significant method
hydration for
antimicrobial
efficacy.
Essentially wet
process.
High concentrations required for 500ppm sporicidal 1-2ppm sporicidal
rapid sporicidal activity. over 8 hours. at 25 C. 1 log
reduction every 1-
2 minutes.
Difficult to control and deliver Significant risks Controlled
over large surface areas and and difficultly delivery contacts
ensure residence time for providing to a all surfaces. New
horizontal surfaces. large area. system available
Overall better for large area
coverage than fumigation
fogging or
foaming.
Difficult to validate........... Validation Validation and
possible. Can be documentation
biologically routinely
verified. conducted. Can be
parametrically,
biologically and
chemically
verified.
Concerns over material Significantly Broad range
compatibility; extent dependant damaging to a material
on contact time and variety of compatibility
antimicrobial agent/formulation. surfaces, even
after single
exposures.
Concerns already
noted in
cleanroom
applications.
Not safe on electrical equipment Not safe on Safe on electrical
electrical equipment
equipment.
Efficacy inhibited by presence Efficacy inhibited Efficacy inhibited
of absorbing materials. by presence of by presence of
absorbing absorbing
materials. materials
Occupational risks significant, Occupational risks Occupational risks
dependant on antimicrobial used. significant, but minimal. Safest
can be minimized. for environment
and personnel
health
Extended contact times and clean- Extended contact Most rapid method
up required. times and and room ready
possible clean-up for use directly
required. following cycle.
Chlorine No residuals.
residuals.
Limited registration, depending Unknown Sterilant used in
on antimicrobial. registration the process
situation with registered with
process. the EPA
Variable efficacy depending on Broad spectrum Broad spectrum
the product. antimicrobial antimicrobial
activity. activity,
including
independant
testing against
and validation
with B.
anthracis.
------------------------------------------------------------------------
For these reasons, VHP is highly recommended for the safe, efficacious
decontamination of rooms as part of an overall strategy for building
decontamination against B. anthracis spores and other potential
bioterrorism microorganisms.
Comparison of Bleach and Registered Sporicidal Products for Liquid
Surface Disinfection
STERIS Corporation.--Comparison Tables
------------------------------------------------------------------------
Registered Sporicidal
Bleach/Sodium Hypochlorite Products
------------------------------------------------------------------------
Slowly sporicidal, depending on active Rapid and consistent
chlorine concentration. Data cited based sporicidal activity; for
on simple suspension study. In our hands, example, synergistic
with purified spore suspension, we showed oxidizing agent
a 2-3 log reduction with B. subtilis formulations at low
spores within 15-20 minute contact. concentrations show a 6 log
Bacillus spore reduction in
<5 mins in similar
suspension studies.
Decreased time required at
higher concentrations of
the product. Enhanced
efficacy due to synergy
between actives.
Not registered sporicide or passed routine Registered sporicide,
EPA requirements for antimicrobial virucide, bactericide and
efficacy. fungicide
Significant reduction in activity when Demonstrated rapid activity
spores present on a surface or in the on a surface and in the
presence of organic or inorganic soil presence of soils.
(either on the contaminated surface or in
the water used to dilute the product).
Aggressive and damaging on surfaces, Broad range material
especially at sporicidal concentrations. compatibility, depending on
product formulation
Not widely used for high risk surface Widely used and validated in
decontamination. the pharmaceutical and
research industries for
antimicrobial, including
sporicidal efficacy
------------------------------------------------------------------------
For these reasons, registered sporicidal products would be a more
desirable product for high risk contaminated areas.
Comparison of Antimicrobial Foam, Liquid Chlorine Dioxide and
Registered Sporicidal Products
------------------------------------------------------------------------
Registered
Foam or nanoemulsions Liquid Chlorine Sporicidal
Dioxide Products
------------------------------------------------------------------------
Very slow sporicidal activity, Rapid sporicidal Rapid sporicidal
requires long exposure times. activity, activity
depending on
product claims.
Not registered, experimental Some registered... Registered,
technologies. validated and
widely used in
regulated
environments
Would require demonstrated broad Broad spectrum Broad spectrum
spectrum efficacy demonstration efficacy for efficacy claims,
by required standard methods those products including
for product claims. with regulated sporicidal,
claims. bactericidal and
virucidal
Unknown material compatibility.. Limited material Broad range
compatibility. material
compatibility
under laboratory
and in-use
conditions/
experience
Foam needs to `release' active Liquid immediately Liquid immediately
(broken) to be available for available for available for
antimicrobial activity. instant instant
antimicrobial antimicrobial
activity. activity
------------------------------------------------------------------------
APPENDIX A
TAB C
STERIS Corporation
features of current proposal and proposed alternatives
B. anthracis--concentration of 1012 organism/gm
Infectious Dose 50 percent (ID50) of
6,000-10,000 spores
Potential for cutaneous anthrax with as little as 5-
50 spores in animal trials.
Development of infection will also depend on the health
and immunocompetence of an individual
Building has contaminated and uncontaminated sections.
No approach 100 percent effective for decontamination.
No one method is capable of doing the entire
decontamination process, but a logical series of steps can be taken to
maximize the decontamination process
Decontamination should be conducted with registered
products/processes that are widely used for similar applications and
will minimize damage to a wide variety of surfaces.
Building should be sealed and contamination mapped. High
and low risk areas should be identified and interventions (either
single or multiple) conducted to reduce infection risks associated with
each area.
Verification of process effectiveness by process
monitoring and documentation
Retesting for contamination following decontamination to
confirm effectiveness.
------------------------------------------------------------------------
Draft Remediation under Consideration Alternate Considerations
------------------------------------------------------------------------
Approach for disinfection Drapes, papers and rugs will
HEPA vacuuming not be adequately
Bleach for hard surfaces disinfected by ClO2 and may
Use of antimicrobial foam actually reduce the
1000 ppm of ClO2 overnight or longer efficacy of room
Whole building, including non- fumigation.
porous materials, i.e. papers, drapes and Treatment of paper and
rugs etc. to be treated by ClO2 drapes by ethylene oxide or
ClO2 believed to be compatible irradiation is recommended,
for short term exposure independent of whatever
Health considerations for ClO2 fumigation technique is
deemed reasonable adopted.
Diluted bleach solution for hard Treatments should be
surfaces has been deemed compatible considered and chosen to
assure as low spore count
as possible rapidly and
safely on any surface.
Registered products with
proven efficacy for this
purpose should be adopted.
Diluted bleach will give
variable results depending
on the surfaces treated,
will require long exposure
times, will not be
effective in certain
conditions and will damage
certain surfaces
Treatment of carpet by
strong sporicidal products
directly can give higher
assurances
ClO2 (liquid or gas) will
damage surfaces such as
metals and paints at the
exposure time recommended
Vapor H2O2 (VHP) applied in
dry state will cause less
damage and is widely
accepted, safe and
sterilant registered for
this application.
------------------------------------------------------------------------
______
APPENDIX B
Comparison of Room Decontamination Methods
----------------------------------------------------------------------------------------------------------------
Gaseous chlorine
Fogging/foaming Formaldehyde dioxide VHP
----------------------------------------------------------------------------------------------------------------
Variable coverage and distribution... Variable coverage and Depending on mode of Controlled delivery
distribution. delivery, more system for more
reliable distribution. reliable distribution.
Difficult to maintain Kinetics of
in gaseous state; can maintaining gaseous
condense. state is understood
and important for
process effectiveness.
Wet methods.......................... Requires significant Requires significant Dry sterilization
hydration for hydration for method
antimicrobial antimicrobial
efficacy. Essentially efficacy. Essentially
wet process. wet process.
High concentrations required for High concentrations 500ppm sporicidal over 1-2ppm sporicidal at 25
rapid sporicidal activity. required for rapid 8 hours (but needs to C. 1 log reduction
sporicidal activity. be kept in the dark). every 1-2 minutes.
Difficult to control and deliver over Significant risks and Significant risks and Controlled delivery
large surface areas and ensure difficultly providing difficultly providing contacts all surfaces.
residence time for horizontal to a large area. to a large area. New system available
surfaces. Overall better Overall better for large area
coverage than fogging coverage than fogging fumigation
or foaming. or foaming.
Difficult to validate................ Difficult to validate.. Validation possible. Validation and
Can be biologically documentation
verified. routinely conducted.
Can be parametrically,
biologically and
chemically verified.
Concerns over material compatibility; Can be damaging to Significantly damaging Broad range material
extent dependant on contact time and surfaces. to a variety of compatibility
antimicrobial agent/formulation. surfaces, even after
single exposures.
Concerns already noted
in cleanroom
applications.
Not safe on electrical equipment..... Not safe on electrical Not safe on electrical Safe on electrical
equipment. equipment. equipment
Efficacy inhibited by presence of Stable, difficult to Efficacy inhibited by Efficacy inhibited by
absorbing materials. remove. presence of absorbing presence of absorbing
materials. materials
Occupational risks significant, Significant Occupational risks Occupational risks
dependant on antimicrobial used. occupational and significant, but can minimal. Safest for
safety risks. be minimized. environment and
personnel health
Extended contact times and clean-up Extended contact times Extended contact times Most rapid method and
required. and clean-up required. and possible clean up room ready for use
required. Chlorine directly following
residuals. cycle. No residuals.
Limited registration, depending on Limited registration, Unknown registration Sterilant used in the
antimicrobial.. traditional use. situation with process. process registered
with the EPA
Variable efficacy depending on the Variable efficacy...... Broad spectrum Broad-spectrum
product. antimicrobial activity. antimicrobial
activity, including
independent testing
against and validation
with B. anthracis.
----------------------------------------------------------------------------------------------------------------
__________
Battelle Memorial Institute,
November 28, 2001.
Ms. Cameron Taylor,
Committee on Environment & Public Works,
U.S. Senate,
Washington, DC.
Ms. Taylor: Per your request I have prepared brief summaries of
some significant methods of decontamination. I have grouped these into
Chemical Methods and Physical Methods. The Chemical Methods of
decontamination are further divided into Alkylation and Oxidation
methods, however, please keep in mind that in spite of decades of
research, the exact mechanism of microbicidal action is often not well
understood. Please recognize this is not an all-inclusive list of
methods used for decontamination, disinfection, sanitization or
sterilization, however, I believe I have covered most of the standards.
Note certain of these methods, for example hypochlorites, actually
represent a group of closely related chemicals. Note too that certain
combinations of these fundamental methods provide synergy that is
exploited for specific applications, for example hydrogen peroxide is
used together with ultraviolet light, peracetic acid has been used in
conjunction with plasma and so on. For confidentiality purposes I am
not at liberty to include proprietary formulations, however, many, if
not most of those, use permutations the basic methods listed here. For
each method I have tried to address the fundamental considerations for
a good decontaminant:
Safety
Efficacy
Toxicity
Economy
Penetration capability
Environmental impact
Temperature of use
Commercial availability
I may not have addressed capabilities of a specific methodology of
interest to you, please let me know if there is more information I can
provide. I look forward to hearing from you and hope you will allow me
to respond to any questions you may have.
Respectfully,
C. Daniel Rowe, Ph.D., Research Leader--Chemistry,
Battelle Memorial Institute.
______
Decontamination Methods--Bacterial Spores
chemical methods--alkylation
Alkoxides--DS2
Beta Propiolactone
Ethylene oxide/Propylene oxide
Formaldehyde /Formalin/Paraformaldehyde
Glutaraldehyde
Methyl Bromide
Nanoparticles
Phenolics
Quaternary Ammonium Compounds
chemical methods--alkylation
Chlorine
Chlorine dioxide
ECASOL
Fichlor
Hydrogen peroxide
--Liquid
--Vapor
Hypochlorite
Iodine
Peracetic acid
Ozone
physical methods
Alcohols
Plasma
Radiation
--Electron beam--Gamma--X-ray
--Ultraviolet
Sorbents
Steam
chemical methods--alkylation
1. Alkoxides
Decontaminating Solution No. 2 (DS2).--Decontaminant Solution
number 2 is the standard military decontaminant used on vehicles,
equipment and building exteriors. It falls into the general class of
decontaminants called ``Alkoxides'', where strongly alkaline materials
(such as sodium hydroxide or potassium hydroxide) are dissolved into an
organic solvent forming a very strongly basic solution. DS2 consists of
70 percent diethylenetriamine, 28 percent ethylene glycol monoethyl
ether and 2 percent sodium hydroxide. DS2 requires 30 minute contact
time with the surface being decontaminated and must be thoroughly
rinsed off with water after decontamination. DS2 will neutralize many
chemical and biological agents but does NOT kill spores (anthrax or
otherwise), is corrosive to some metals, will soften leather and may
soften remove or discolor paint. DS2 is toxic (protective masks, gloves
and aprons must be worn during application). DS2 is flammable and will
ignite of sprayed on surfaces over 168+ F. DS2 is explosive
when mixed with certain other decontaminants such as Super Tropical
Bleach (cf. Hypochlorites). The military has over 2 million gallons of
DS2 in inventory.
2. Beta Propiolactone
Beta propiolactone is an organic liquid that is used as an
intermediate in chemical synthesis. It is also used to sterilize
vaccines, grafts and plasma. It has been proposed as a substitute for
formaldehyde in decontamination of rooms and buildings. Research has
shown beta-propiolactone to be 1000 times more active than ethylene
oxide and 25 times more effective than formaldehyde, however it is not
recommended as a substitute for ethylene oxide because it does not have
the penetrating power of ethylene oxide. It has been shown to cause
cancer in mice.
3. Ethylene Oxide/Propylene Oxide
Ethylene oxide (EtO) is a colorless, flammable, toxic gas at room
temperature (boiling point 51 degrees Fahrenheit). EtO has been used
for the past 50 years as the principal method for sterilizing heat
sensitive equipment (e.g. surgical equipment) and as an agricultural
fungicide and fumigant for foodstuffs and textiles. To reduce the
explosion hazard EtO is often mixed with a nonflammable, nontoxic gas
such as carbon dioxide or CFC's (fluorocarbons). EtO causes cancer and
mutations, is highly irritating to the eyes and can cause pulmonary
edema. It is normally employed inside a closed pressure vessel
specifically designed for EtO sterilization. Because of its low boiling
point, EtO is used at high concentrations (300 to 1,200 mg/L) and
thereby has excellent penetrating capabilities. EtO is noncorrosive and
highly sporicidal. A major disadvantage of EtO is that it dissolves
into materials such as plastics and hence requires long aeration
periods (e.g. 12 hours) to eliminate the residual gas. Also EtO is only
effective above specific humidity levels.
Propylene oxide is similar to EtO but is a liquid at room
temperature (boiling point 95+ F is higher than EtO) and is
used more often on foodstuffs in the liquid form.
4. Formaldehyde/Formalin/Paraformaldehyde
Formaldehyde is a colorless, flammable gas (boiling point minus 3
degrees F) at room temperature. Formaldehyde is used as a germicide in
either the gaseous or liquid state and is a potent respiratory
irritant. Formaldehyde is toxic and has a pungent suffocating odor that
is intensely irritating to mucous membranes and eyes and causes contact
dermatitis, violent coughing, and death if ingested. Formaldehyde is
known to cause cancer. OSHA has established employee exposure limits of
0.75 ppm for 8 hour time-weighted average exposures and 2 ppm exposure
for 15 minutes (short-term exposure limit). Formaldehyde readily
polymerizes with itself thus leaving a sticky residue. It also readily
condenses on cold surfaces such as doors making it difficult to control
the exact desired concentration. Formaldehyde does not penetrate into
porous surfaces, fissures or device lumens. It is noncorrosive,
however, it does require >70 percent humidity to be an effective
biocide. The preferred contact time is 18 to 24 hours. Explosions occur
when formaldehyde concentrations exceed 7 percent.
Formaldehyde gas is employed in specially designed pressure vessels
as a medical device sterilant (Europe). Formaldehyde gas is also
produced by heating formalin (aqueous solution of formaldehyde gas) or
paraformaldehyde (a white powder that is a polymerized form of
formaldehyde). A quantity of the powder is placed in a frying pan and
heated. It is used to disinfect sickrooms, clothing, linen and sickroom
utensils. Paraformaldehyde (formaldehyde) is sporicidal and is
routinely used in Fort Detrick, MD to decontaminate buildings in which
anthrax has been used. Sensitive equipment and books etc. are required
to be removed from the room or building prior to decontamination. After
decontamination using formaldehyde several days are required for
aeration and washing (walls etc.) using copious amounts of water to
eliminate odor and toxic residue. Residual formaldehyde levels can be
very high in polyester, rubber and cellulosics (paper, cotton, wood
etc.). Disposal of formaldehyde must be completed in accordance with
regulations for toxic waste.
5. Glutaraldehyde
Glutaraldehyde is ``double aldehyde'' and a chemical relative of
formaldehyde except it is used in an aqueous solution. Like
formaldehyde, glutaraldehyde has irritating odors and toxic fumes.
Glutaraldehyde is sold widely in 2 percent aqueous solutions for use in
hospital instrument disinfection and surface decontamination for
temperature sensitive instruments that cannot be steam sterilized. It
is known to cause skin and eye irritation and causes some people to be
extremely sensitive to its vapors as it builds in their system (it is
used as an embalming fluid at 25 percent). It is relatively
noncorrosive, however it's effectiveness is strongly influenced by pH,
temperature and concentration. For example, at high pH and high
temperature (120+ F) glutaraldehyde's efficacy is poor,
likewise at low pH and low temperature (65+ F) it also has
poor efficacy. Glutaraldehyde (2 percent) rapidly kills some organisms,
however, to be sporicidal it requires 10 to 14 hours contact time.
Rinsing is required after glutaraldehyde decontamination.
Glutaraldehyde penetrates device crevices and can be difficult to
remove because it produces an intractable polymeric residue.
6. Methyl Bromide
Methyl bromide is a colorless, odorless, extremely toxic gas at
room temperature. It has been used to fumigate poultry houses,
warehouses, vaults, mills and freight cars. It has also been used to
extract oils from nuts, seeds and flowers, however residues have raised
questions about safety aspects for consumers. Methyl bromide has a
greater penetrating power than formaldehyde and is more easily diffused
from buildings than formaldehyde. Although Methyl bromide is effective
against a wide range of bacteria and viruses, I do not know the
efficacy against spores such as anthrax. High concentrations are fatal
to humans; chronic exposure can cause depression of the central nervous
system and kidney failure. Due to its extreme toxicity, there has been
great concern over distributing this gas in small fire extinguishers.
7. Nanoparticles
Nanoparticles refer to compounds that have been made in such a way
that they have unusually small particle sizes. Even though they are
solid materials the sizes of the solid particles are in the molecular
range (0.000,000,15 inch). This has the effect of enormously increasing
the surface area of the bulk material and changing the chemical and
physical properties. (Seven grams of nanoparticles have the surface
area equivalent to a football field). Although there appears to be a
great deal of research underway on nanoparticles two approaches (that I
know of) have been proposed for decontamination.
Metal oxides: By manufacturing common metal oxides (for
example magnesium oxide) using an aerogel process, it exhibits
properties it would not normally exhibit. These ultra small particle
sized metal oxide particles have been doped with chlorine or bromine
and demonstrated to kill some spores under certain conditions within 1
hour. A disadvantage of this method is that the material is a finely
divided powder and as such is extremely difficult to remove from some
sensitive equipment, fabric, machinery, joints and crevices.
Nanoemulsions: A second approach to nanoparticles is
called ``Nanoemulsions''. This technology employs a fat/oil phase (e.g.
soybean oil) with a water phase containing detergent and other
additives blended using a great deal of force (shear forces). The
result is an extremely small oil droplet that is able to react with and
disrupt the membrane of bacteria and hence exhibit antimicrobial
activity.
These emulsions require up to 4 hours to achieve complete spore
kill. Nanoemulsions would be difficult to use for buildings due to the
residue remaining.
8. Phenolics
The organic liquid, phenol or carbolic acid is one of the oldest
germicidal agents used in the hospital environment. The parent chemical
has been replaced by hundreds of derivative compounds referred to as
phenol derivatives or phenolics (an example of this is resorcinol).
Phenol no longer plays a significant role as an antibacterial agent.
These are considered to be moderate to low level disinfectants used for
environmental surfaces and non-critical devices in institutional and
commercial environments. Phenol derivatives are also used as
preservatives and antibacterial agents in germicidal soaps and lotions.
Since small amounts of phenolics (1 percent to 2 percent) remain active
when in contact with gross amounts of organic soil, phenolics are often
the disinfectant of choice for general housekeeping and laboratory
disinfection. Phenolics are difficult to rinse from most materials and
residues may irritate skin, cause depigmentation and cause injury to
mucous membranes. Phenolics are not sporicidal.
9. Quaternary ammonium compounds
A wide variety of quaternary ammonium compounds (e.g. benzalkonium
chloride) have been used since their introduction as liquid chemical
germicides in 1935. A great deal of study has gone into examining the
relationship between chemical structure and biocidal properties. These
compounds vary greatly in their structure and likewise vary in their
water/oil solubility and hence their microbicidal properties. The
biocidal activity is derived, in part, from the surfaceactive
(surfactant) nature of these compounds. These compounds find extensive
application in consumer products but in most cases do not appear to
exhibit pronounced sporicidal activity.
chemical methods--oxidation
1. Chlorine
Chlorine is a reactive, greenish-yellow gas with a suffocating odor
that is dangerous to inhale. Chlorine readily reacts with almost all
chemical elements (except noble gases, carbon and nitrogen). It is used
for bleaching, purifying and disinfecting water and is extremely
valuable as a chemical intermediate for hundreds of materials
(plastics, rubber, chlorinated organic chemicals). Gaseous chlorine was
used as a chemical weapon in World War I. Chlorine gas exhibits rapid
biocidal activity. Chlorine, in aqueous solution, even in minute
amounts, exhibits fast bactericidal action. Early research showed that
aqueous solutions of chlorine get their biocidal activity by the
formation of hypochiorous acid (cf. Fichlor and ECASOL).
2. Chlorine Dioxide
Chlorine dioxide is a gaseous oxidizing agent that has been used
for many years as a drinking water disinfectant and as a bleaching
agent for paperpulp, flour, leather, fats, oils, textiles and beeswax.
It is unstable at higher concentrations so, like ozone, it must be
generated onsite. Its solutions can emit toxic and corrosive fumes that
require its use to be restricted to locations having proper engineering
controls. It is reacts violently with organic chemicals and is unstable
in sunlight, 10 percent concentrations can easily be detonated by
sunlight, electrical discharge or decompose explosively. Chlorine
dioxide is a more severe respiratory irritant than chlorine and a 19
ppm concentration has reportedly caused occupational fatality.
Inhalation exposure symptoms include coughing, wheezing, runny nose,
eye and throat irritation, headache, vomiting, bronchitis and pulmonary
edema (a life-threatening accumulation of fluid in the lungs).
Pulmonary edema may be delayed for several hours after exposure.
Chlorine dioxide also may ignite combustible materials for example
mixtures with fuels may explode and chlorine dioxide containers may
explode when exposed to heat, fire, friction or contamination.
Sewer run-off may also create a fire or explosion hazard. Bacterial
spores have not been the primary test organisms since spores are not
generally regarded as important waterborne pathogens consequently the
efficacy of chlorine dioxide against anthrax spores may need to be
studied.
3. ECASOL
Electrochemically activated solution (ECASOL) is produced by
applying a short-term (0.3-0.6 sec) mild electrical charge (5-9 amps at
8-12 volts) to a dilute brine solution (less than 1 percent salt) as it
passes through a flow-through electrolytic module (FEM). Electrolysis
occurs (i.e. separation of the ions using an electric current) thus
producing a highly oxidative solution. The primary active ingredient of
the solution is hypochlorous acid. Because hypochlorous acid at the
applied concentration is a weak acid (neutral pH) it is non-corrosive
and safe for skin, eyes and wounds. In addition to being a weak acid
and skin-safe, hypochlorous acid is an oxidant so powerful it is an
effective biocide even at low concentrations. The biocidal efficacy of
hypochlorous acid (pH 7) is many times greater than the biocidal
efficacy of an equivalent amount of its chemical relative, hypochlorite
(pH 10). ECASOL at 0.035 percent (350ppm active chlorine) kills 100
million anthrax spores on a test coupon instantaneously. The active
ingredients in ECASOL are relatively unstable and decompose readily in
the environment reverting back to the starting materials of salt and
water.
4. Fichlor
Fichlor is a commercially available oxidant (sodium d
ichloroisocyanu rate). It is used as a sanitizing and disinfecting
agent in commercial bakeries and as a bleaching agent, swimming pool
disinfectant, dishwashing detergent and in cleaner formulations. It is
believed that, in aqueous solutions, the reactive species is
hypochlorous acid. Fichlor dissolves in water at the same rate as
calcium hypochlorite and is used similarly to calcium hypochlorite.
5. Hydrogen Peroxide
Liquid Hydrogen Peroxide.--Hydrogen peroxide is a noncarcinogenic,
nonmutagenic nontoxic liquid oxidant that decomposes to environmentally
safe, residue-free by-products (water and oxygen). It is widely used
for bleaching, aseptic food packaging, dairy processing, medical device
sterilization (e.g. hemodializers, pharmaceutical preparation areas)
and bacterial reduction and odor control for sewage effluent. Hydrogen
peroxide solutions have been used as surface disinfectants for 150
years. Aqueous hydrogen peroxide solutions in relatively high
concentrations (10-30 percent) are observed to have sporicidal
capability (note >50 percent peroxide solutions are extremely dangerous
and can be unstable). Lower concentrations (e.g. 6 percent) require
lengthy contact times (30 minutes or greater) in order to be
sporicidal. Hydrogen peroxide has some material compatibility problems
at high concentrations (nylon embrittlement, oxidizes aluminum and
discolors anodized aluminum etc.). Hydrogen peroxide requires long
contact times in order to kill resistant bacterial spores. Hydrogen
peroxide is the primary active ingredient of the Sandia Foam
decontaminant.
Vaporized Hydrogen Peroxide.--Cold gaseous hydrogen peroxide is
known to be a sporicide at low concentrations. Hydrogen peroxide is a
far more effective sporicide in the vaporized form than it is in liquid
solutions (note this is not a mist or a fog but a dry gaseous vapor).
It exhibits a broad range of microbicidal activity over a broader
temperature range than ethylene oxide having been shown to be an
effective sporicide at temperatures as low as 4 degrees C and as high
as 80 degrees C. The sporicidal efficacy of gaseous hydrogen peroxide
improves with increasing concentration, increasing temperature and
increased exposure time. Greatest lethality is achieved at near
saturation levels. It is effective on exposed, clean, dry surfaces when
there are no contaminants such as liquids, oils, salts or organic
residues to impede penetration. In other words it is an effective
surface decontaminant and does not have the penetration capability even
close that of ethylene oxide. Note cold surfaces readily condense
vaporous hydrogen peroxide and hence greatly reduce the peroxide
available for decontamination. Vaporized hydrogen peroxide is rapidly,
efficiently and cleanly decomposed by metal catalysts (e.g. platinum)
to water and oxygen. Decontamination can be achieved in relatively
short contact times; thus, minimizing concern over material effects on
items being processed. Because of the sporicidal nature of vaporized
peroxide at low concentrations (<10mg/L), at room temperature (<80
degrees F) and because of the inherently low toxicity of hydrogen
peroxide and its by-products it is employed as a non-toxic cold gas
sterilant for medical devices.
6. Hypochlorite compounds
Calcium hypochlorite is a powerful oxidizing agent and bleaching
agent. Aqueous hypochlorite solutions have high pH (alkaline) and hence
have hydroxide ion present as well and are thus caustic and corrosive.
This limits its biocidal effectiveness and adversely effects material
compatibility. Hypochlorite solutions are made by mixing dry calcium
hypochlorite and water. The military employs 0.5 percent bleach
solutions as personnel decontaminant in spite of the fact that it is
highly irritating to the skin and cannot be used in eyes or wounds.
Note sodium (as opposed to calcium) hypochlorite is sold commercially
as a 5 percent solution (Clorox) but sodium hypochlorite is
not stable as a dry solid. The military employs HTH (high test
hypochlorite) and STB (super tropical bleach) Hypochlorite solutions
can ignite spontaneously on contact with DS2. Solutions of 0.5 percent
calcium hypochlorite (2800 ppm active chlorine) kill one hundred
million anthrax spores on a test coupon in 30 minutes. Hypochlorite
solutions in excess of 1 percent create toxic chlorine gas vapors.
7. Iodine
Iodine is a grayish-black solid that looks like metallic scales. It
is very slightly soluble in water and forms a brown solution. Compared
to chlorine the chemistry in water and activity is much more complex.
Iodine reacts not only with living organisms but dead ones and
dissolved proteins. Iodine is able to penetrate the cell wall of a
microorganism rapidly. Many disinfectant formulations employ iodine or
iodophors. lodophors are a combination of elemental iodine or triiodide
with a carrier. Here the iodine is stabilized by an appropriate
surfactant (surface active agent). Iodine itself is bactericidal,
fungicidal and sporicidal. It is most active as acid pH (i.e. low pH).
lodophors (iodine carriers) retain the sporicidal strength but not the
undesirable properties of iodine and are active over a wide temperature
range.
8. Peracetic acid
Peracetic acid is essentially vinegar (acetic acid) with an extra
oxygen atom. Peracetic acid has been known as a germicide for almost
100 years. It is a powerful oxidant, has an acrid odor, is corrosive to
the skin and explodes violently when heated to high temperatures.
Dilute aqueous peracetic acid solutions are used in the food industry
as a disinfectant spray (dairy industry, fruits, vegetables for mold
growth etc.). Prolonged exposure with peracetic acid will damage most
materials and it will cause burns and blisters on the skin. It is a
strong acid and as such is very corrosive to metals; however, buffered
solutions containing anticorrosion additives are widely used (0.2
percent concentration) as a sterilant for surgical devices. Liquid
peracetic acid has been used for years to reprocess kidney dialyzers
and to sterilize immersible surgical instruments whereas vaporized
peracetic acid has been used in combination with plasma for medical
device sterilization and is used by the CDC as a high level
disinfectant.
9. Ozone
Ozone is triatomic oxygen and is a pale blue gas (boiling point
minus 170 degrees Fahrenheit) that is relatively unstable. The half-
life of gaseous ozone in ambient atmosphere is 12 hours and the half-
life of aqueous ozone is 30 minutes. It is the most reactive form of
oxygen and has a very high oxidation potential second only to fluorine
therefore it is one of the strongest oxidants known. Ozone must be
generated onsite and is used to disinfect drinking water, reduce odors
in the paint industry, as a bleaching agent and many other
applications. High concentrations are injurious and cause severe
irritation of the respiratory tract. Generally, ozone is known to be a
more effective bactericide and virucide than chlorine and chlorine
dioxide. Because of the highly oxidative properties of ozone, it
appears to be best used for decontaminating items composed of silicone
rubber, ceramics, polyvinyl chloride, polyurethane or metals such as
titanium, stainless steel, platinum and other metals inert to reaction
with oxygen.
physical methods
1. Alcohols
The alcohols have been appreciated for centuries for their
antiseptic qualities. As a chemical group, the alcohols possess many
features desirable for a decontaminant. They are bactericidal against
non-spore forms, are relatively inexpensive, easily obtained, nontoxic,
have a cleansing action and evaporate readily. They are much less
powerful against spores than they are against vegetative organisms.
Alcohols are believed to get their biocidal activity by denaturing
proteins. This is shown to be far more effective in the presence of
water, hence water and alcohol mixtures have much greater biocidal
activity than absolute alcohol. Methyl alcohol (wood alcohol) is the
weakest of bactericidal action of the alcohols and is seldom considered
for use as an antibacterial agent. On the contrary ethanol (ethyl
alcohol) when water is present is a very effective bactericide against
vegetative organisms; however it has little effect against bacterial
spores. The bactericidal action of isopropyl alcohol is slightly
greater than that of ethanol. The inability of alcohols to destroy
bacterial spores makes their use as a decontaminant inadvisable.
2. Plasma
Plasma is sometimes referred to as a ``fourth'' state of matter (as
compared to solid, liquid and gas). A majority of all matter in the
universe exists as plasma. Plasma is best thought of as a high energy
``soup'' consisting of a mixture of atomic fragments including positive
ions, negative ions, free electrons and free radicals (no charge).
Plasma is a good conductor of electricity and is affected by magnetic
fields. The light or ``glow'' from plasma occurs as electrons reassume
their positions (i.e. decay) in the atomic orbitals from whence they
came and in so doing, releasing a photon of light. Examples of plasma
include neon lights, the northern lights, fluorescent lights, lightning
and many stars. Industrial plasmas are used for their destructive
properties on materials, for example, the auto industry uses plasma to
strip polypropylene surfaces and thereby improve paint adhesion to the
surface. The semiconductor industry uses plasma for etching surfaces.
Although low temperature plasmas have been claimed to serve as stand-
alone method of decontamination, in no case has plasma alone been used
without having an additional (chemical) decontaminant present. For
example, one medical device sterilizer uses plasma along with vaporized
hydrogen peroxide as the sterilant, another uses vaporized peracetic
acid as the sterilant. As a result there is not a strong argument to
use plasma as a stand alone decontaminant. Plasma suffers from the
disadvantage of not having great penetrating power, will react with
paper and other materials, is inactivated by highly absorptive
materials, is unable to enter small deep lumens (i.e. passages) and is
significantly reduced in efficiency by the presence of blood or salt
crystals.
3. Radiation
Radiation can be classified into two main groups: electromagnetic
(e.g. ultraviolet, gamma, x-rays and microwave) and particle radiation
(alpha, beta, neutrons etc.). Radiation produces bactericidal effects
by transferring the beam energy into ionization of the biologic target
(except in the case of ultraviolet). This effect is usually produced
with no perceptible rise in temperature and is therefore referred to as
ionizing radiation for ``cold sterilization''. Greater than 50 percent
of medical devices sold sterile are irradiated (especially high volume
disposables); radiation is also used for food sterilization.
Electron beam (radiation).--Electron beam radiation or ``E-beam''
radiation is a stream of high-energy electrons (i.e. beta particles)
accelerated to a high energy in a radio frequency linear accelerator.
E-beam radiation is an alternative to ethylene oxide and gamma
sterilization. E-beam sterilization is accomplished by exposing a
product for a predetermined time to the high-energy electron beam.
Exposure to E-beam disrupts the bonds of vital metabolic components
bonds in a microorganism, rendering the exposed product sterile. In
order to achieve adequate penetration the electrons must be accelerated
to high energies, consequently E-beams are usually large expensive
machines and generally require massive shielding capabilities to
protect personnel. To provide a shield from the energy produced,
products are often processed in a concrete bunker. More recent models
have been developed that are smaller and have more compact shielding.
E-beam is the method currently being used to decontaminate mail from
anthrax. The use of E-beam is limited due to limited ability of the E-
beam to penetrate various materials and related dosimetry problems. E-
beam is usually most effective when the load put through the beam is
very uniform and hence the dose is also uniform. Throughput rates
(dose) are determined by the beam energy and conveyor speed hence it
has the advantage of being able to be turned on and off (unlike
radioactive sources of gamma radiation). E-beam will severely embrittle
and hence crack some plastics such as polypropylene; it will harden
polyethylene and can discolor some materials such as cellulosics (wood,
paper, cotton).
Gamma (radiation).--Gamma radiation is electromagnetic radiation
generated from a radioactive material. Gamma radiation is a method of
commercial sterilization accomplished by exposing products to cobalt-
60, an isotope that emits gamma radiation. Gamma-sterilization is a
one-step process that does not require any preconditioning or post-
processing treatment of the product. (During the radiation process the
packaged products are loaded onto conveyor system that transport
products through an irradiation chamber or cell.) While cobalt-60 emits
radioactive energy, this energy does not cause exposed substances to
become radioactive, as a result, sterilized products have no residual
radioactivity and can be shipped safely to customers immediately after
processing. The dose applied to the product is determined by the amount
of cobalt-60, the distance from the radiation source and the duration
of the exposure to the radiation source. Products are typically
processed using gamma radiation in 8 hours or less. The use of gamma
radiation as a sterilization method is limited by the radiation
compatibility of certain plastics and other materials that may
discolor, deform or become brittle when exposed to gamma radiation. The
use of gamma sterilization has increased in the past 10-15 years as
medical products manufacturers have converted sterilization from
ethylene oxide to gamma sterilization and have increasingly used
radiation compatible materials in the new products. Gamma radiation has
low environmental impact under normal operating conditions since there
are no chemical residuals on the sterilized products or emission
released by either the process or the sterilized product. Gamma rays
have an advantage over E-beam in that gamma has generally better
penetration power, however it suffers from the major disadvantage that
radioactive sources cannot be turned on and off and require periodic
replenishment due to half-life decay (cobalt-60 decays at 12 percent
per year hence has a half life of 5.6 years). Gamma radiation also
requires costly disposal of the spent cobalt-60. Potential liabilities
associated with gamma radiation include worker exposure and radioactive
contamination resulting from the use of cobalt-60.
X-ray (radiation).--X-rays are like gamma rays in that they are
both electromagnetic waves. X-rays differ from gamma rays in that they
are different wavelengths (hence different energy). The mechanism for
decontamination with x-rays and gamma rays is the same for both. The
difference is that different energy levels penetrate materials at
different levels.
Ultraviolet (radiation).--Ultraviolet radiation is called
``nonionizing'' radiation because it does not cause ionization (i.e. it
does not cause the electrons to be excited out of their orbital
shells). Ultraviolet radiation has been proven to be a very effective
biocide and is widely used for purification of air and water. The most
practical method for generating UV radiation is by passing electrical
discharge through mercury vapor in special glass tubes. Special glass
tubes are required because ultraviolet light will not pass through most
glass. The fluorescent lamp operates on the same basic principle
producing ultraviolet energy. The difference between the two is that
the fluorescent lamp is coated with a phosphor that converts the UV
energy into visible light (glass used in most fluorescent lamps filters
out all germicidal ultraviolet). The germicidal ultraviolet lamp is not
coated with the phosphor and uses a glass that permits UV to pass.
Since living organisms have the ability to repair some damage due to
ultraviolet radiation, germicidal lamps must provide enough energy to
exceed the tolerance limits to create lethal effects. Experiments have
been done demonstrating whole room decontamination using several
germicidal lamps employed simultaneously.
4. Sorbents
Sorbents are usually finely divided (small particle) powders that
consist of essentially inert materials such as carbon, silicon dioxide,
aluminum oxide, diatomaceous earth, kaolin, soil that adsorb chemicals
on the sorbent surface. Sorbents, in general, do not react chemically
to neutralize a contaminant but adsorb it on the surface so it can be
physically removed. Sorbents can be made that will physically absorb
many times their weight in specific chemicals. Sometimes the sorption
process can be reversed by heating the sorbent in order to release the
adsorbed chemical; on the other hand sometimes adsorption is
irreversible. Sorbents can be chemically modified (e.g. polymeric
sorbents) to make them chemically reactive toward specific chemicals
(i.e. a chemical reaction as opposed to the normal sorption process
which is physical). Sorbents are more often used for removal of
chemical agents rather than for biological organisms.
5. Steam
Steam sterilizers or autoclaves have been made in America for over
a hundred years. Steam sterilization is perhaps the most widely
accepted method for decontamination and has been extensively studied;
the mechanism of microbial inactivation using heat is fairly well
understood. Since World War II increasing use of
plastics and heat sensitive materials has spurred development of
numerous low temperature decontamination methods especially in the
medical device arena. Nevertheless, steam sterilization continues to be
a workhorse for hospital sterilization of non-heat sensitive
instruments and has found limited application in decontamination of
infectious waste.