[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

                              ----------                              

                            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

                              ----------                              


                       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.
  

                                
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