cc >> Welcome, everyone, to
Wednesday Nite at the Lab. I'm Tom Zinnen.
I work here at the University of
Center, and I also work for UW Wisconsin Madison Biotechnology
And on behalf of those folks and Extension Cooperative Extension
Public Television, the Wisconsin our other sponsors, Wisconsin
Science Alliance, thanks for Alumni Association, and the
Lab. We do this every Wednesday
night, 50 times a year. Tonight, I'm delighted to be
able to introduce to
She's a Research Compliance Specialist and an Alternate
Responsible Official
Select Agent Program. I told for UW-Madison's
about being a compliance her I would tell a joke
could come and talk speciato my children.if she
[LAUGHTER] I think
talk about alternate my children would
[LAUGHTER] In addition, resRebecca is as.
certified biosafety professional
Safety Association and a with the American Biological
with the National Registry of Certified Microbiologists.
She's from Manitowoc. She received a bachelor of
science in bacteriology and a master of science in medical
immunology, excuse me, medical
both here from UW Madison. She microbiology and immunology,
academic and private sector laboratories where she developed
a knack for biosafety,
compliance. Her title biotonight: "Biosafety,ch
Compliance, and UW Influenza
Please join me in welcoming Rebecca to Wednesday Nite at the
Lab. [APPLAUSE]
Okay, my battery is green,
Okay, so I apologize, first of can everybody hear me?
inverse didn't really all, thiwork very well.PC to Mac
I've been invited to talk to you
been a significant amount of this evening because there's
influenza research studies. The mfirst one was conducted here
at the University of Wisconsin
Dr. Yoshi Kawaoka. Now, Madithat manuscript wasry of
submitted to the journal Nature,
done in the laboratory of Dr. aRon Fouchier at the Erasmuss
Medical Center in Rotterdam,
Now, these studies have been in the spotlight since November of
2011 when the National
Board reviewed both manuscripts Sand came to the unprecedentedy
decision that the journals
scientific information. shNow, they came to thishe
conclusion based upon the dual
used as a biological weapon. use potential of this work to be
grabbing headlines, of which I There have been many attention
Too Dangerous for have cWords. Contagion.ow you.
Now, the New York Times in an editorial referred to these
viruses as the
And some journalists have gone Dooms Day viruses.
the Manhattan Project. Now, asthis unprecedented decision to
and resulting media attention has caused debates among various
scientific circles, among influenza experts themselves,
government's biosafety and
results of these debates we bioobviously don't know yet. end
We're still in the
But it will not only affect the research in these two
manuscripts but will also affect
potential dual use concerns. So altonight we're going to coverh
a couple different topics.
brief information about UW's We're going to go over some
what it is. We're Selecgoing to talk aboutactly
influenza virus in general, a little bit about the
manuscripts, what I can tell
Scientific Advisory and yoBiosecurity Board, and thennal
we're going to get into biosafety and biosecurity.
My goal this evening is to show you what is not routinely being
discussed in the media. Most
amount of oversight involved in this research, and what we do to
mitigate influenza
There's been a lot of misinformation and omission of
facts regarding these studies.
straight about this research, and I'm going to give you what
is hopefully enough information so you can come to your own
conclusion about this research. So I think the best place to
begin this unprecedented journey
involved with it. So is to say exactly how I'm
Research Compliance Specialist you know that I'm the
and I'm one of two Alternate for UW's Select Agent Program,
So what is this program? Now, after the 2001 anthrax
attacks, the federal government set up a program that requires
all registered laboratories and entities that work with select
agents to be preregistered. Now,
is comprised of various bacteria, viruses, and toxins.
As a result, UW created their own Select Agent Program.
Currently, we're comprised of just under 200 individuals who
are registered to either work directly or indirectly support
the laboratories of seven principle investigators who work
with bacteria, toxins, and
pathogenic avian viruses, including highly
Now, each entity is required to have a Responsible Official, and
our Responsible Official is Dr. Bill Mellon who is the
Associate Dean for Research Policy, and, in his absence,
myself and another individual,
Officials, have the authority asto act if necessary.le
Now, essentially, my job is to
of the Select Agent Program manand to make sure we are inons
compliance wit the
At the same time, I need to be regulations at all times.
their research that ablethey want to do safely.s do
So I wear many different
I have to know microbiology. I hats to be able to do this.
and guidelines. I have have to know the regulations
training, containment, and even from time to time I have to be
able to speak engineering. So what happens if I do not do
my job correctly and we have a
Well, worst case scenario, violation of the regulations?
jail. There could Dr. Bbe a hefty fine oro to
select agent research as a whole
Now, it is a privilege to be a on campus could be stopped.
with select agents, and that registered entity and to work
any time. Now we're privgoing to get on to they at
bug of the hour. We're
about influenza virus. Now, UW Madison has a longe
history of ground-breaking
the late 1940s. Swine inflinfluenza viruses wereg in
first isolated here, and it was also shown by Dr. Easterday,
who's sitting right there, that swine influenza viruses could go
from pigs to humans, and
Now, influenza virus is a single-stranded, negative-sense
RNA virus. Now, its genome is comprised of
eight genes, which you see here.
translated into 10 to 11 Now, these eight genes are
virus. Now, like all proteins depending upon the
proteins coming off of viruses, it has
Now, in the case of influenza virus, you have spikes coming
off of the particle. Now, this rod-shaped spike is
known as the hemagglutinin, otherwise known as the HA.
Now, it is responsible for
and then an initial penetration aof the cell during infection.l
Now, the sequence of this HA, the hemagglutinin, determines
what type of cell it can attach to, albeit a human cell, a pig
cell, a poultry cell. Now,
subtypes of hemagglutinin that there are 16 different
nature so far. Now, this exist and have been found in
right here is the neuraminidase, mushroom-shaped spike
Now, the NA plays a role in whrelease and spread of newNA.
viruses. Now, there are nine different
subtypes of neuraminidase that
far, and a subset of antiviral have been isolated in nature so
those compounds is compounds are the target of
Now, influenza viruses are named the neuraminidase.
neuraminidase subtypes. by So, H1N1 is type 1 of theheir
hemagglutinin and type 1
H5N1 or H3N2, for example. Now, because these stick outside
of the virus particle, this is
response to. When we what our bodies form an immune
influenza virus, our body forms the immune response to the HA
and the NA. When we get the influenza
vaccine, if you actually get the
sequences of the HA protein shoand then the NA protein.in
Now, what happens if two
infect one cell? Albeit, different influenza viruses
cell, or a poultry cell. a human cell, an animal
particles, they infected the As you can see, the two
resulting virus particles samelook like parents.the
Now, when this happens in nature, there are technically
256 different types of virus
Now, this does not take into particles that can be created.
single time influenza virus replicates, mutations occur
because there the viruses do
replication errors not have the capability to fix
So this is where the potential like our cells do.
exists. This is how viruses are
generated that create, that have resistance to antiviral
compounds. A mutant virus arises that is
resistant to antiviral compounds
pressure, say that person is because there is a selective
virus, one of these mutants occurs and it can keep growing.
So the virus develops resistance
Now, this is also how mutant or reassortant viruses could arise.
For example, how an H5N1 virus
from person to person. Now, coinfluenza viruses have beenit
around a long time. There have been episodes of
respiratory illness back to the middle ages and before.
Now, a pandemic virus is a
sustainably and efficiently virutransmit among humans. to
In the 20th and 21st century
most notably the Spanish there have been four pandemics,
Now, this pandemic killed ibetween 20 million and 40.
million people with a mortality rate of roughly about 2.5%.
And most recently was the 2009
was a virus that was a pandemic virus, which actually
swine viruses. Two of the reassviruses they've beenerent
able to figure out what they
not. Now, the were,majority of the human have
population has only ever been exposed to the H1, the H2 and
the H3. Now, also people of the younger
generation have not even been exposed to H2 because the
dominant seasonal influenza strains right now are H3N2 and
H1N1. Now, influenza viruses are
currently known to infect many different mammals.
For example, humans, horses,
recently influenza viruses dogs, pigs, poultry, and most
Now, a virus that infects one hspecies might not be able to
infect another because of the sequence of the receptor of that
hemagglutinin gene. But selective pressure can cause
this jump. An example is a few years ago in
Florida at a racetrack you had
proximity to each other and because of selective pressure, a
virus that infected horses was
canines, and as a result, awe have canine influenza
circulating across
Now, bird flu, what is the the United States.
Now, in 1997, bird flu first big deal about bird flu?
market in Hong Kong. Now, inthere were 18 cases withry
six deaths, and the only thing
was the fact that they had been that a live poultry market then
week earlier. As a
authorities ended up culling result, Hong Kong
the source of the virus. 1.5 million poultry to remove
reemergence in 2003, it has spread from Asia to Europe and
Africa. Now, bird flu has become
entrenched in poultry populations of some countries,
resulting in millions of poultry infections.
Now, in these countries the poultry infections have impacted
the livelihood of the economy and international trade.
Now, as of early February of
confirmed cases of H5N1, this year, there have been 584
that have led to 345 deaths. otherwise known as bird flu,
roughly 59%. Now, the Now, ththree hardest hit rate of
countries have been Indonesia,
order. As of December Egypt, 15th of 2011,in that
Indonesia had 182 cases with 150 deaths.
Egypt had 155 cases with 53 deaths.
And Vietnam had 119 cases with 59 deaths.
So you have sick poultry and a
that poultry, and humanthen they get sick. with
Currently, there has been very limited human to human
transmission of bird flu viruses.
There have been a few cases of direct contact when an
individual has been taken care
also a caregiver. Now, of by a close family member or
sick individual that passed it in these instances, the
had extremely high titers on of virus in their bodies.has
Now, some influenza experts debate whether or not it is even
possible for bird flu to
another person, but H5N1 viruses transmit from one person to
person, we would have another pandemic because the majority of
the human population has never
thus, it's critical to know whether or not these viruses can
be transmitted. In 2006,
of Allergy Infectious Disease had an influenza panel, and the
panel determined that more work needed to be done to understand
the transmission of influenza viruses.
Then in 2009, the World Health
research agenda for influenza and said this exact type ofr
research needed to be done. So what would make bird flu
transmissible in humans? Now, this was one of the main
goals of Dr. Kawaoka's research.
to determine what was required One of his research projects was
person to person. Now, for bird flu to transmit from
when Dr. Kawaoka received a grant from the National
Institutes of Health entitled The Pandemic Potential of H5N1
Influenza Viruses. Now, in
additional grant from the Gates Foundation to identify influenza
virus amino acids that are
transmission. So what respodid Dr. Kawaoka do? human
So they took H5N1 virus and then
influenza virus and they they took the pandemic 2009
Now, the HA, the hemagglutinin made a reassortant virus.
and the remaining seven genes gwere from the pandemic 2009,
virus. Now, they
they infected ferrets. One took that virus and
ferret next to the day later, they put another
Now, the only way for this other infected ferret.
to get infected with influenza ferret, this uninfected ferret
droplets. Now, these virus is through respiratory
next to each other, but they are not touching.
So the only way the one ferret
through respiratory droplets. cNow, what were the results ofis
this experiment? Well,
virus, there was no transmission with this reassortant
So they made a second virus where they made mutations in
that H5 hemagglutinin gene
Now, this time all six contact and infected ferrets.
influenza virus. Now, why feuse ferrets to do thisr
research? Ferrets have a similar
respiratory tract to humans, and
symptoms when human and theferrets get influenza.ar
While the ferret model is a good
transmission, it is not a good model to study the influenza
influenza viruses model tamongst humans.ssion of
Now, the ferrets used in these
susceptible to influenza. They experiments are incredibly
that they have zero antibodies are screened to make sure
experiments start. Whereas, to infus humans, we havee the
antibodies to influenza virus.
unethical to do experiments on But since it is scientifically
best model we have. So what humadoes this data tell us? the
This data suggests that it could
viruses to transmit from person beto person via respiratorylu
droplets. So let's
the time line of events. So the manuscript was submitted
to the journal Nature at
Now, internally we were worried about putting out a manuscript
that talked about the potential of a virus to transmit from
person to person when a movie called Contagion was coming out
which talks about a killer virus
and panic ensues. Well, thluckily, we didn't have tod
worry about that, but we had a
So instead of being published initially, the manuscripts went
to the National Scientific
Now, what is this board? This Adboard was established in.
2004, and its first meetings began in 2005.
Now, their charter is to provide
regarding biosecurity oversight aof dual use research, which isp
defined as biological research
purpose that may be misused to with legitimate scientific
public health and/or pose a biological threat to
Now, currently, the NSABB has 23 voting members
and 18 non-voting members. The
Secretary of Health and Human Services in consultation with
other federal departments that
research. Now, the NSABB have an interest in life science
four overlapping years, and the members provide expertise in a
wide variety of areas. I
but there are 20 different areas would name all the areas off
Office of Biological that are listed on the NIH
But, essentially, they cover Activities website.
disease, public health, intelligence, security,s
biodefense, etc. nd the NSABB also has ex officio
members from 15 agencies and
law enforcement, national dsecurity, things like that.n
Now, the NSABB's roles as it's
an advisory board. They stdo not review manuscripts be
unless there is extenuating circumstances, and this is the
first time to my knowledge the
and it is most certainly the NSABB has reviewed a manuscript,
manuscript that significant data should be withheld from.a
So, the NSABB came out with their statement on December 20th
that the manuscripts, as a
Those mutations that are whole, should not be published.
not be published, but the requiinformation should beshould
disseminated to individuals who need it.
Now, that posed the question, how do you disseminate
information to the surveillance teams that need this but make
sure it doesn't get to anybody else?
But as the saga unfolds, on January 20th, 39 influenza
researchers published a commentary that they would
voluntarily give up this
And I don't think it is fair of me to paraphrase their words, so
I'm going to read a little
"We recognize that we and the rest of the scientific community
need to clearly explain the benefits of this important
research and the measures taken to minimize its possible risks.
We propose to do so in an international forum in which the
scientific community comes
these issues. We realize together to discuss and debate
and governments around the world that organizations
find the best solutions for nopportunities and challenges
that stem from the work.
discussions, we have agreed to a To provide time for these
any research involving highly pathogenic avian influenza H5N1
viruses leading to the
more transmissible in mammals. generation of viruses that are
live H5N1 or H5HA reassortant Inviruses already shown to beith
transmissible in ferrets will be conducted during this time.
We will continue to assess
influenza viruses that emerge in the transmissibility of H5N1
threat to human health." nature and can pose a continuing
Dr. Kawaoka had not spoken Now, up until this point,
He requested and received ppermission from Nature toh.
discuss a few key details of his
published in Nature. Now, study the first and mostat was
important, the H5N1 transmissible virus here at the
University of Wisconsin does not kill ferrets.
I'm going to repeat that again. Our virus does not kill ferrets.
Our virus is also susceptible to
also currently current antiviral compounds and
The second piece of critical available vaccines.
the mutations that are required infor transmission are alreadyf
circulating in nature. And
information was that Dr. then the last piece of
influenza transmission is more Kawaoka's data suggests that
involves not only the receptor complex than anticipated,
hemagglutinin, but also other bbiological and physicale
properties. Now, the
bridge the gap between these first step in trying to
February 16th and 17th when the World Health Organization had a
meeting in Geneva, Switzerland. Now, this meeting was an
invitation-only meeting. The
were influenza researchers from around the world, including
Dr. Kawaoka and Dr. Fouchier, the chair of the NSABB, the head
of NIH, and then the heads of the WHO Influenza Surveillance
Centers, and also the editor
Now, again, I'm going to read a little bit of the WHO news
release. "The result
have made it clear that H5N1 of this new research
transmit more easily between viruses have the potential to
critical importance of continued humans, underscoring the
the virus." Now, this survemeeting, there wereh with
four key points that
First of all, the group decided that this research must
continue. They
moratorium on the research for agreed to extend the
They also agreed that delayed publication of the entire.
manuscript would be more
publishing a partial manuscript. beneficial than urgently
to be increased public awareness And that, lastly, there needed
research through communication and understanding of the
biosecurity aspects. Then alast week another incident
was thrown into the loop, I guess.
So, the American Society for
biodefense in emerging Microbiology had their annual
Now, during this conference, disease conference.
which had the chair of the they had a panel discussion
director of the National NSABB, another NSABB member, the
Infectious Disease, the editor Institutes of Allergy and
also Dr. Fouchier. Dr. of Science magazine, and then
pieces of information also about his research.
Most importantly that his virus as well does not kill ferrets
when it is passed through transmission experiments.
But when he inoculated that virus directly into the trachea,
so basically directly inoculating the virus into the
lungs, it did kill ferrets. And also during this meeting,
this discussion, it was announced by the director of
NIAID that he has asked the NSABB to review these
manuscripts again and also to review new data that has come to
light. So they are
NSABB will look at these hoping that the
this month. So keep manuscrpaying attention. end of
We'll see where this goes. So,
at my notes, that brings us to biosecurity and biosafety.
Now, what measures are taken
Wisconsin Madison to mitigate risk with influenza research?
Now, there's a tremendous amount
research or any influenza ofresearch on this campus that1
falls underneath the
Now, this research is under sa microscope at both the
institutional and the federal level.
Now, the first level of oversight applies to the entire
university. All laboratories that work with
recombinant DNA at UW Madison must abide by the NIH
recombinant DNA guidelines. Now, these guidelines lay out
the framework for how work
conducted, but then also how an institution should review this
type of research. So each laboratory conducting
recombinant DNA research must have a biosafety protocol.
Now, this protocol describes the
vectors, organisms, cell lines, rplants, animals, facilities,e
exposure response, and then also
recombinant DNA guidelines. Then this protocol is submitted
to the Office of Biological Safety, and then the Office of
Biological Safety works with
work out all the details of the protocol and to make sureo
everything looks right. Then
to the UW's Institutional thaBiosafety Committee.ted
Now, the Institutional Biosafety
subject matter experts. There Care public members, andf
this committee also has a group of consultants at its disposal,
of which I am one. Now, the IBC will determine if
the protocol and the risk assessment meet the NIH
recombinant DNA guidelines. And they will also take into
account the CDC's Biosafety and Microbiological and Biomedical
Laboratories, which is also known as BMBL, and those also
are a set of guidelines. Now, this protocol will either
be approved or it will be sent
depending upon what backthe IBC determines.sions
Now, no research on this campus with recombinant DNA can be done
without and approval from the Institutional Biosafety
Committee. Now, just
research on this campus is not as a side note, animal
Biosafety Committee. It is reviewed by the Institutional
of the five Institutional Animal actually reviewed by one
exist on this campus. Now, Care and Use Committees that
oversight comes from the the second level of
The Centers for Disease Control and Protection and the Animal
and Plant Health Inspection Service, which is part of the
USDA, are in charge of the
Now, the Criminal Justice Information Service, which is a
division of the FBI, does the background checks for everybody
that works in this program. Now,
must pass that background check before they can work with select
agents. Our file is held by the CDC, but
we also have oversight from APHIS because we have agents
that fall underneath
Now, an entity is registered for both categories.
is no more than three years. And a limited amount of time which
I'm sorry, at the end of that registration time, a renewal
inspection has to occur, and
They look at our facilities, federal inspectors come in.
look at our training, and they they look at our documents, they
on the NIH recombinant DNA follow checklists that are based
guidelines to determine whether guior not our renewal, ourMBL
registration should be renewed. Now, renewal of an entity's
registration is never a given,
during that registration period, and, also, at any point in time
in unannounced and to go the federal inspectors can come
Now, at the heart of both of through the facilities.
something called these levels of oversight is
Now, biological safety is the discipline of addressing the
safe handling and containment of
hazardous biological materials. inThe two main principles ofd
biosafety are containment and risk assessment.
Now, the goal is to protect the laboratory worker, the
environment, and the public from exposure to infectious
microorganisms that are handled and stored in the laboratory.
Now, how does biosafety do this?
Now, the first control of Bbiosafety is engineering, ands.
when I'm talking about
talking about the facility engineering, I'm not just
about equipment used inside the facility that is used as primary
containment when
Now, you know you want conduct working with an agent.
viruses, what type of wfacility do you need?za
Well, if you look at the NIH
states that this work needs to recombinant DNA guidelines, it
with enhancements. If you be look at the CDC's BMBLl 3
guidelines, it states that
biosafety level 3 with a shower thout and a clothing change.t
And it also states that infected
worked with at BSL loose-housed animals need to be
Now, what do these mean? Now, biosafety level 3 has a
large range of requirements depending upon the agent.
There are a few things that are required, and then depending
upon the agent, other things are added.
Now, the goal of a biosafety
inside the laboratory. An leveindividual goes into thetays
laboratory, equipment goes into the laboratory, materials goes
into the laboratory, everything that goes in is contamination
free. Now, everything that comes back
out of that facility, including the worker, equipment,
materials, waste, including air,
all contamination free. waSo what is required for also
biosafety level 3? Well,
have controlled access. Not just anybody can get into
this area. The doors have to be
self-closing. Work has
biosafety cabinet which is to be done inside of a
for working with an agent. It cocollects all the aerosols.nt
There has to be directional air flow in the facility.
So air basically flows from clean to dirty, never the
reverse. Always clean to dirty.
Now, that air, to get out of the
HEPA filter which will remove all bacteria or viruses that are
in the air. All penetrations
are sealed. So electrical ioutlets, screw
holes, nail holes, all of those are caulked so air cannot get in
or out. There has to be an autoclave.
Now, an autoclave uses heat and pressure to kill bacteria in
solid waste and viruses in solid waste.
Now, another piece of safety
They have those O rings around, let's see if you can see, right
here. That's an O ring to help keep
any aerosols inside the centrifuge.
Then also, you see that worker's
Now, that cup itself has got a special cup in their hand.
So that cup can be taken out, taken into the biosafety
cabinet, and then opened. So any aerosols that were
generated when those tubes were centrifuged stays inside the
biosafety cabinet is not
Now, we said that this work according to the NIH and CDC
guidelines had to be done at
3 enhanced. Now, what somethiis enhanced mean?ty level
So there has to be a personal change and a shower room.
So you can't just walked into the lab.
The doors have to be lockable.
so that outside door and that inside door can never be opened
at the same time. Only one
any given time. There has to be bio-seals on an
interlocked double-door autoclave.
So this is an example of a large
can get pushed in to. So bulk autoclave that animal cages
side right now, and on the other we're looking at the clean
up into the sidecontainment facility.opens
There has to be independent air and exhaust, and our facilities
have redundant systems. So
a second system to back it up. if one system fails, we have
of displaying the Therepressure differential.eans
So when I said there had to be
air flow directional, it goes from an area of higher pressuree
to lower pressure. Now, this gauge will tell you
when you walk into a room that
going into is negative and that pressure of the room you're
Now, we're also required to collect liquid waste, like I
said, that come out of facility.
normal BSL 3 enhanced and we Now, we go one step ahead of a
effluent decontamination system. have something that's called an
collects all the waste from the laboratories, and these smaller
two tanks down here are used
sterilize, all the liquid waste that come out at the facility.
Now, all the duct work that leads up to those HEPA filters
in the exhaust system, we have
absolutely no leaks to main that duct work. are
So the only way for that air to get out is to go through the
HEPA filter. And lastly,
backup power. Now, this was the level of the
facility that was used to generate the transmissible H5N1
viruses, just the actual
Now, what is the BSL propagation of the virus.
Now, BSL 3 agricultural suite builds upon a BSL 3 enhanced
suite and just takes it to a whole new level.
Now, this facility is considered primary containment.
It is designed to be
So take a shoe box and inside of a box within a box.
box. And inside of that shoe box, you have another
you have an animal that little box,
A pig, a horse, a cow. That's what these facilities are
designed for. The walls of our facility are
18 inches of a continuously poured concrete.
They have overlapping layers
throughout the entire walls. of three-quarter inch rebar
walls they are epoxy-coated so Now, on the inside of those
walls and everything that nothing can get through the
Now, to get into the facility you don't just enter into one
room and go into the laboratory.
a series of rooms to get You actually have to go through
Also, all the doors for the perimeter are air-locked doors.
As you can see, they kind of
The black right here are look like submarine doors.
air gaskets that fill with air, and that is how the containment
seal is made. So the
work itself are also pressure decay test which means a
facility has to hold air within a certain for a certain period
of time. So basically,
balloon and that balloon holds you blow up a
time. That's what that aithese containmentmount of
facilities have to be able to do except you do the reverse.
You pull it negative and make sure that there are no leaks and
the facility can hold the pressure for a certain amount of
time. Now, the
an EDS system which is why all requirement of BSL 3 is
are connected, all of our ocontainment laboratories are
connected to it. We also
instead of having loose-housed went one step ahead and
ferret experiments inside of animals inside, when we do our
in isolator cages that have tHEPA filters on the cages that
collect all the virus particles.
able to gas decontaminate this And then, lastly, we have to be
use chlorine dioxide. Now, entire facility, and, for us, we
containment that a laboratory is, the more expensive it is.
Containment facilities are
operate, and maintain. It inis also difficult to findld,
qualified personnel who know how
also facility engineers that to work in these facilities and
facilities operate and how actually understand how these
Now, since the select agent regulations went into effect,
the cost to do one research paper on Ebola virus, which is a
biosafety level 4 virus, went from $59,000 to $333,000 to make
one peer reviewed journal article.
Now, all those systems in our facility are redundant.
Now, with redundancy
Our BSL 3 and our BSL 3 agricultural suites were built
exactly for highly pathogenic avian influenza virus.
We built this facility
research. In the end, explicour building costspe of
were roughly $12.5 million. So
is protected. Now, we have the environment that
working inside the facility? what about the worker
equipment comes into place. You Noneed to protect the portalsive
of entry for a virus. Now,
infects somebody through the in nature influenza virus
droplets. So the most inhaimportant piece ofory
personal protective equipment for a worker working with
influenza virus is
Now, in this instance we use the respirator.
powered air purifying something respirators. which are
But also in the laboratory you
high concentration and you are working with agents at a
So you also have to protect your others portals of entry.
So individuals working in these types of facilities take off all
their street clothes, and they put on scrubs.
Then they put on a
They put on booties inside Tyvek jumpsuit.
They have double gloves on, and they have their PAPR respirator.
So it basically looks like
space suit. So now you you're wearing sort of like a
protected and you have the have the environment
Now, how else can we mitigate risk inside the laboratory?.
Now, we use something called
which basically help prevent standard operating procedures
put a worker at risk. Now, practices that could potentially
different individuals doing one thing the same way and achieving
the same outcome. Now,
that way, it's actually quit when you think about it
because every one who reads it difficult to write an SOP
the same way, and have the same outcome when performing the same
procedure. So SOPs
aspects of the containment are written for all
exit, how to shower out of the facility, including entry and
is an SOP for how to shower, facility, I kid you not, there
moving equipment, how to working with viruses in animals,
equipment, and all aspects decontaminate facility
Now, the last element of of emergency response.
side which puts engineering, the biosafety is the administrative
and SOPs together personand into practice.pment,
Now, one of the first and most
is training. I cannot imporemphasize to you howtasks
important hands-on training is. We're required to give program
and laboratory specific training
when the CDC and APHIS on at least an annual basis, and
through all of our training idocumentation to ensure that
every registered individual has received the appropriate
training. Now, I'd
work in one of our containment like to note that to
you have to go through an fextensive mentoring programs
before you're aloud to work in
viruses by yourself. Now, thdocumentation is anothere
large task for the
There is a significant amount of paperwork involved in every
single thing that we do, and a
always additional approvals to large majority of time there is
just do a simple task even. We're required to do inspections
on an annual basis. So
Alternate Responsible Official, we go through all of our
registered facilities. We look at the laboratories.
We go through their documentation.
We look at their
Just like we were the CDC and APHIS inspectors, and we use
their exact checklists as well. Now, lastly, we have a few
administrative policies in place
All of our staff that work with tH5N1 influenza viruses have to.
get seasonal influenza virus to prevent symptoms and infection
with seasonal flu. In addition, individuals cannot
have pet birds. There is a quarantine policy,
and if you were in the
go to a zoo or a petting zoo containment facility, you cannot
five days post-working in whthe containment facility.for
And also, we have an
asks you to disclose any health immchanges you have to yourch
principal investigator that would make you more susceptible
to the bugs you work with. Now, our influenza program has
an excellent track record, and
Agent Program we have invested a as part of our entity Select
oversight, and engineering significant amount of training,
Now, a lot of the questions we've been getting from the
media are what-ifs. What if this happened?
What if that happens? What are you going to do?
So I can tell you we have a written incident response plan
that covers all natural and man-made disasters from fires to
blizzards to earthquakes, gas leaks, floods, tornadoes,
explosions, and power outages.
and revise and conduct drills on Now, we are required to review
an annual basis. For any this incident response plan on
agent facility, the Responsible Official and the Alternate
Responsible Officials are notified immediately, either by
the principal investigator or by the UW Police Department
depending upon the
Now, it is the responsibility of nature of the emergency.
immediately contact the CDC thand let them know we have anto
emergency. Now, what about medical
emergencies? Staff are
medical emergencies such as heart attacks or if somebody
falls. Staff know how to move a
conscious or unconscious
containment facility, remove individual out of the
and hand them off to their PPE, decontaminate them,
Now, because of the risk to first responders, they will
never enter our containment facilities that work with H5N1
influenza viruses. We have
the Madison Fire Department using a neutral hand-off site
that works best for both parties.
Now, I can also assure you there
deal with potential exposures or are medical plans in place to
influenza symptoms. Now, in quarantining staff who have
gotten about criminal acts. We another question we've
deal with suspicious packages, also have plans in place to
people, work place violence, thefts, bomb threats, suspicious
And, again, these plans we're required to review, revise, and
drill on an annual basis. We teach our registered
individuals what type of threats to look for.
What type of people, insiders,
inclusion, and also what type of outsiders, visitors, people in
against our facilities. Safe actions these people could take
inventory, our facilities and documents is absolutely
essential. The main intent of the select
agent regulations is to protect inventories from theft, loss,
and release. Now, because of this, our Select
Agent Program works incredibly
Police Department, and we also closely with the UW Madison
with our local FBI officials. have Now, this brings us tonship
biosecurity. Now, biosecurity is a term that
is becoming more prevalent
It is the protection of microbial agents from loss,
theft, diversion, or
Now, we do not publicly talk intentional misuse.
have in place for our Select about the security measures we
tell you is that the UW Madison AgePolice Department does aan
thorough security risk
that house select agents assessment of all our facilities
We have multiple physical bebarriers in place, our.
facilities are monitored
cyber security. We run extensively, and we also have
security, to test staff training drills each year to test
measures. Now, UW prMadison has somethinger
that, from what we know, is very
Biosecurity Task Force. Now, unique, and it's called the
was established by former chancellor John Wiley as an
advisory tool to the
Now, this task force is chaired by the Responsible Official and
is comprised of key individuals from around campus who have a
vested interest in the
Now, represented on this security of our select agents.
Responsible Officials, task force are the Alternate
colleges that have select agents, the Environmental Health
and Safety including the Office of Biological Safety and
Occupational Medicine, I'm
also the director of sorry, Occupational Health and
UW Communications, Legal, UW Environmental Health and Safety,
Wisconsin State Laboratory of Hygiene, and also the Wisconsine
Veterinary Diagnostic Laboratory.
Now, the Biosecurity Task Force meets monthly to discuss all
issues pertaining to select agents on campus with a focus on
security and constantly improving the program.
We have been told by multiple federal agencies that this is
the best practice. Now, we've talked about the how,
the what, the where, but
There's been a little nbit of why in between..
So why do this research?
simple: it is for the overall benefit of global public health
by preventing disease. Now, outbreaks and pandemics
happen. They happen quickly and we do
not have years to figure them out.
The goal is to figure out what
will be prepared in coulcase it does happen.o we
Now, it is only a matter of time
more orange and more poultry are before this map is covered with
Since this graph was published culled and death tolls increase.
beginning of February, there by the journal Nature in the
deaths, two in Vietnam and one have been at least three more
infections in Vietnam, in Bangladesh with additional
And also most recently as of Bangladesh and Egypt.
there's an outbreak in the live bird market in Bangladesh.
In addition, in the state of
that are dying from bird flu. Now, the H5N1 study done heres
shows that the possibility
mutate and transmit from person to person, and we already know
that a subset of these mutations
already circulating in nature. required for transmission is
is absolutely essential that Now, this research shows that it
mutations to look for and that surveillance teams know what
compounds and vaccines that care effective against thesel
mutations. Now, with
have a few acknowledgments. First of all, I would like to
thank UW Madison for investing
When the regulations went into in the Select Agent Program.
the research that would eventually become select agents.
Now we have one of the larger programs in the country, and we
have very good support
I would like to thank our Responsible Official, Bill
Mellon, for sharing his knowledge, his vast expertise,
and allowing me to grow into my role in the UW Madison Select
Agent Program. I'd also like to thank my fellow
Alternate Responsible Official, Darren Berger.
He's listening hopefully. He
in a nutshell, I could not fully is a facility engineer, and,
expertise. I'd like do mto thank Dr. Kawaoka.p and
It's not always easy being a
cutting-edge research. He forhas embrace biosafety anding
biosecurity and made it the number one focus in his
laboratory. And I would also like to thank
his lab managers who, from what I understand, are also watching
online. You guys do a wonderful job of
making sure everything
I'd like to thank the Office runs smoothly.
Environmental Health and Safety. of Biological Safety and
of coworkers who work hard and They are a knowledgeable group
also, at the same time, they are always willing to help, but
But lastly, and certainly not knleast, I want to thank Terry.
Devitt and Jill Sakai from UW Communications.
I really cannot thank them
guidance and trust during enthese last six months.d
They have handled every single
this university during this meunprecedented journey in annto
exceptional manner. From
saga, it has been truly unlike anything we have ever
encountered before. And needless to say, it has been
educational for all of us. And
questions that you guys have. [APPLAUSE]