Import_Permit-Day-2_Part-1


>>Hello and welcome
to webcast day two. We had a very interesting and
informative session yesterday. Wealth of knowledge. We are very fortunate to have
a team of experts in one place to reach out a nationwide
audience. They’re here again today. We encourage you
to please use them. I’m hearing again the federal
and international partners, speakers from today and
will be speaking today. They come from the Department
of Agriculture animal and Plant Health Inspection
Service, The Department of Commerce, The Department
of Health and Human Services to include The Office of
the Assistant Secretary for Preparedness and Response,
Customs Border and Protection, Centers for Disease
Control Preventions, Divisions of Select Agents
and Toxin, and Division of Global Migration
and Quarantine. We are going to have speakers from Food and Drug Administration, and we heard
Ms. Tamesha Woulard yesterday. Fish and Wildlife, today we
are going to have speakers from the Department
of Transportation and the Public Health
Agency of Canada. Again, I encourage you to
please send your questions to [email protected]
as I mentioned earlier, it is not very often
that we have a team of experts in one place. Please use them. Send your questions
[email protected] And now we go to
the first speaker for this afternoon,
Cinthia Labrie. She’s the licensing program
manager, Center for Biosecurity, Public Health Agency of Canada, where she oversees activities
involving human pathogens and indigenous [inaudible]
animal pathogens. She will talk about
import and export of human pathogens
and toxins in Canada. Cinthia?>>Hello everyone, and I
want to thank the organizer for inviting me today. The Canadian PHAC right now is
experiencing a lot of change. We have been intensively
working in creating a regulation and a [inaudible]
this last December. So for many of you, you might
have seen previous documents, previous regulated
documents that we have issued. We have now stepped into a new
age, a licensing program age, and you may see new
documents coming up here. So today is a good
timing for you to actually see what we have
achieved and where we are going when it comes to importing and exporting human pathogen
and toxins in Canada. So this is a n overview of
what I’ll be presenting today. I will start by talking about
pathogens regulations in Canada in general so you can see
where my agency is related to other agencies or
departments in Canada. And then I’ll talk a bit
more about who we are as the Center for Biosecurity. We will talk briefly
about the acts and regulations administered
by our center. I know they are not necessarily
related to you guys, but still, if you are dealing with
Canadians, they have to abide to these regulations
and therefore, when you entertain conversation
and discussion with them, they might be talking about
it or asking you elements to make sure that they
fulfil those requirements. I’ll then talk about
regulated activities, and I’ll touch briefly on
exclusion and exemptions. Our goal when we created
this new regulation was to make sure we would be
able to control the risk of human pathogens and
toxins, but at the same time, we didn’t want to
burden the Canadians, especially research
denominator diagnostic, so we have created exemption
and exclusions specifically for certain activities. Then I’ll be talking about
the licensing program, which is the program
I manage daily. I will talk about the
Canadian Biosafety standard, which is very similar
from your BMBL. Then I’ll finish with
the regulatory documents, so you’ll be able to see what
we’ve been doing in the past, and some of those documents
are still current until — and valid until the
end of this year. We’re in transition
period right now. You’ll be able to see the other
documents including the letter that you can see here — letter to acknowledge to
receive an application, which is a transitory
document and will be only valid for a certain period of time. So this slides gives you a
picture of Canadas framework when it comes to regulations of
pathogens and toxins in general. So you can see there
are a lot less agencies and department regulating
pathogens in general. Although you can see some
actors are not present because I didn’t want to go
into drugs and other things like that, but you
can see the ones that are directly
related to pathogens. So it starts up above with
Global Affairs Canada, and they are responsible
for the toxicological and biological agent on
the export control list. And then they administer the
export and import permits act. And then when we go into
Canada, or right at the border of Canada, we have the
Canada Border Service Agency, also known as CBSA, which would
be your equivalent for a CBPB. On the right side here,
the control of transport of dangerous goods in Canada in
overseen by Transport Canada. And then we go into the
three big departments that do control activities or importation/exportation
regulation regarding pathogens. First of all is Environment
Canada, and it’s a duel regulation,
or they work together. Environment Canada/Health
Canada, they work together to administer the CEPA, the Canadian Environmental
Protection Act, and specifically
the new substance notification regulation. So it relates to new substances,
GMO Organism, and Microorganism that are not present in Canada. They do kind of shadow
or out an umbrella over our own regulation, but their mandate is really
specific for Bio radiation. Everything that is
released in the environment, where the other two groups
you see on the right are more for a lab related usage. I did not put it there, but Environment Canada
is also responsible for the CITES permit for any
endangered species wildlife and everything. So they are also responsible
for that part of — it’s also part of their mandate. Next one is the Canadian
Food Inspection Agency, which would be an
equivalent to USDA. They administer, aside
from the Food and Drug Act, the food part, which
I didn’t put there because it’s not related
to pathogen directly. They administer the Planned
Protection Act, so everything that relates to planned
pathogens. And they administer select —
a lot of elements and sections from the Out of Animals
Act and Regulation. I have to stop here and explain
a bit why you see this division over here. So in 2013, it was
the government decided that they wanted
to merge activities between the human pathogen group
and the animal pathogen group into the One World One
Health perspective. So, during that time, I moved from the Canadian Food
Inspection Agency actually, to the Public Health Agency,
bringing the expertise of the terrestrial animal
pathogens up to this new group. So, the decision was
made at that time that the Canadian Food
Inspection Agency would keep the high risk diseases, such
as [inaudible] disease, emerging animal disease, but also be pathogen
disease animal — aquatic animal disease and
products, and bi-products and those containing
animal pathogens. So at the Public Health Agency,
we now end up with terrestrial and animal pathogens,
those in pure culture, and those indigenous to Canada. So those of lower risk, mainly
your BSL-2. Public Health Agency also
enforce the Human Pathogen and Toxin Act and
Regulation, and this is new and you’ll see it just
at the next slide — in the next few slides. So we cover human
pathogens and toxins. So all we are exactly, the
Public Health Agency of Canada, we are in what we call the
ALP portfolio and on top of us is the Minister
of ALP, but you can see that he is responsible
for many other agency or departments including
ALP Canada, and including Canadian
Food Inspection Agency. So we do work together closely and then we have two other
agencies or review boards that are also related
to medicine or health — human health. Okay, so my center where
I actually work every day, it’s called the Center
for Biosecurity at the Public Health
Agency of Canada. Our role is yes, licensing
for importation/exportation and other activities for
human pathogen and toxins, but we also are the
group responsible for inspecting containment
laboratories including those of high risk to BSL
three and BSL four. We are also responsible
for creating and updating the standards
for those facilities — for those containment
facilities. So our mandate is to administer
and enforce the Human Pathogen and Toxin Act, the
HPTA, The Human Pathogen and Toxin Regulation,
the HPTR, and the Health of Animal Regulation,
HAR, select section of it, like I said before,
to protect the health and safety of Canadians. So again, our acts and
regulations are listed here, and I’ve put a little but
more information into it so the Human Pathogen and
Toxin Act was already in place in 2009, but at that time
we could not enforce all the sections because we
didn’t have the regulation. That regulation,
The Human Pathogen and Toxin Regulation came
into effect December 1, 2015, which is like eight
months from now — eight months ago,
nine months ago. And with that, all sections
and all the requirements came. The Health of Animal Acts and
Regulation, like I said before, we are only working on
select sections pertaining to importation and transfer of terrestrial animal
pathogen indigenous to Canada. I’ll go in and review
of the HPTA, because this is a new
act and regulation. Before we used to have the Human
Pathogen Importation Regulation, and it was repealed
actually the same day that the new act passed. The HPTA provides
new authorities to address risks polls
by domestically acquired or produced human pathogens. In the past, with the
former regulation, we had two types
of laboratories. We had those who had to follow
the requirements in order to be able to import, and then
we had domestically acquired samples and those
labs, the labs working with those samples didn’t
have to follow the regulation, didn’t have to follow the
containment standards. So we have the double standards
and we felt it was a high risk. So this new act, and this new
regs, provide a common standard for all pathogen users. It is a license– we are
licensing activities much more than just importation
and exportation. We actually cover the use,
handling, transfer, import, export, disposal,
abandoning and release. These two we don’t want
to give it to anyone, but still it’s there in the
things they are allowed to do. The other thing that
we have now with — that we have the HPTA and HPTR,
is we have a mandatory reporting of incidents including
lab acquired infections, and we hope this will
provide a lot of information to further advance
containment standards and different guidance
for Canadians. When we created the act and
reg, it was important for us to acknowledge the role
of the biosafety officer. So the Biosafety officer
has actually specific powers in this act and reg, making
them really partners with us. The other thing that was done
is we created the requirements to have security
clearance for those working with security sensitive
biological agents, SSPAs, which would be equivalent
to select agents. The HPTA does not apply to human
pathogen and toxins that are in an environment in which they
are naturally occur as long as they have not been cultivated or intentionally
collected or extracted. This is one of the
exclusion and I’ll talk about it a bit longer period
because this is very important for people dealing with
Canada to understand that there are exclusions
to the act where people don’t
have to have a license. The HPTA does not apply to
risk group one human pathogen and toxin not listed
in schedule one. Schedule one — we
have five schedules and schedule one is
actually embedded in the act. Risk group is something you may
not know what it is, or you may. I’ll stop here and I’ll
just explain quickly. In the United States
you classify your lab and your organism by
biosafety level, BSL. In Canada we have decided to
split — if I can say it– the risk of the pathogen
and the risk of the — not the risk but the
containment level of the labs. So risk group refers to
the risk for the pathogen. So we have just like you
guys, risk group one to four, and they would be equivalent
to your BSL one to four. When it comes to containment
level, most of the time, the risk group is equivalent
to the containment levels. So for example, for salmonella, which is a risk group
two organism. It would have to be in a containment
level two laboratories. But we have realized throughout
the years that sometimes that match is not really there, which is why we CBER
rated the definitions. So then we can say,
for example, for HIV, which is risk group
three organism, a lot of people depending what
they’re doing, can handle it in a containment level two lab. So it’s not just one answer. We kind of CBER rated in piece. But for today, for
the presentation, if I talk about risk
group, or if I talk about containment level,
just think about your BSL. And it should be fine for
today, and we’re not going to go into specific difference. This is a list of the activities
that are covered under the HPTA. So the HPTA does apply to any
known human pathogen or toxin that have been extracted,
immunoprecipitated, concentrated, collected
amplified, cultivated, refined, cultured, and or grown
from such sample. Okay, now we step into the
exclusions and acceptations. Even for Canadians it’s not
very clear, so we do spend a lot of time explaining to
our regulating parties and our stakeholders
what they are. So, I hope I can
achieve at least a part of the comprehension
and I will be available if you need more information. So, a general review of
the exclusions of the act. Our goal there, again,
like I said, was to make sure we would not
burden our regulated party too much. We also didn’t want to
have double regulations where we would step onto another
regulation already in Canada. So the first example is
what I just said a couple of slides ago. Its human pathogen or
toxin in an environment in which it naturally occurs
if it has not been cultivated or intentionally
collected or extracted. As you can see this comes
directly from the act, so that’s the legal language. What it means is if we have
human sample, blood sample, it could be animal sample also,
and contains the pathogens, we would not cover
it under the license. It would only be
covered when we start to cultivate the pathogen inside or we extract the
pathogen inside. So from the collection site up
to the lab it is not regulated. If someone only wants
to store that sample — and that’s true for
soil samples as well, it would not be under the act. It would only start
being in the act, or needed a license once they
start working with the pathogen. That’s basically what
it means in a nutshell. The other exclusion is a drug in dosage form
whose sale is permitted or otherwise authorized
under the Food and Drug Act, ours, such a drug. That is specifically not to
step onto ALP Canada’s toes. So our regulations stop
when theirs starts. Exemptions. So the exclusions I told you
about are related to the act. The exemption I’m showing you
are related to regulation. It doesn’t really change
anything in the long run, but still, if you want to be
picky about it, the exclusion is from the act, the exemption
is from the regulation. So under the Human Pathogen and Toxin Regulations some
control activities are exempt from requiring a license. So we have decided we have
looked at the activities and labs and decided for some
activities we didn’t want to go and ask them to get a license. So the first example
in laboratory analysis or diagnostic testing
that are not producing in human pathogens. An example of that
would be water testing. Water tester, they use color
matrix tests and things like that, so they are not
really producing a pathogen, or if they are — it
could be also PCR test and things like that. So, the water testing refers
more to the second one. So laboratory analysis
or diagnostic testing, if production is done
using a sealed container, and the container
is decontaminated for disposal and re-use. So the water tester,
what they will do, they will particularly water
in the vial, cultivate it for a short time, and then
just look at the color. And the color — if
there’s a color change, it means it’s there or not. And you can see — you can also
have that with petri dishes where you put a film after
the water has passed through and then they wait
and incubate it, and wait to see the colonies. In this case, they are
not doing anything else with the sample after. They just look and
then dispose of it. We decided for these cases, because they are
actually not working with the pathogen itself, that they would be
exempted from licensing. In reality what happens is
a lot of the labs in Canada, yes they do have these,
but they have research and they have other things. So, in the end, you
will see that most of Canadian laboratories
do have a license. But there are small
companies, very few, that will be exempted totally. The third exemption is for veterinarians conducting
testing in a clinic. Again, we didn’t want to step
into someone else’s shoes. So even though they are
exempted, they still have to respect the Human
Pathogen and Toxin Act. One of the elements that the act
says is even though you don’t have a license, you still
need to, what they call — what we call duty of care. You need to be careful, you need
to put safety measures in ace to ensure protection of the
personnel and the environment. And we said to those people,
if you want to make sure that you’re following duty of
care, go see our standards, and follow our standards. This is our gold measures —
safety measures, so use this. They don’t have to,
but it’s preferred. Okay, we talked before
about animal samples, that would be Canadian
Food Inspection Agency. Pure Culture would be us. So I created a slide, one slide, so you can see a bit what
we cover and what we don’t. And about also, included in you
know, the number in brackets, and you can see on the bottom who in Canada would
be responsible for it. So for pure culture for human
pathogens, it would be us. Pure culture for indigenous
terrestrial animal pathogens will also be us. As soon as we get
into pure culture for exotic emerging animal
pathogen, fish pathogen, plant pathogen, like
I said before, this would be Canadian
Food Inspection Agency, and you have the specific
groups underneath there. Human sample or cell line that are not infected
would not be regulated. If the cell line contains
a complete human pathogens, one or many, then it
would be regulated by us. Animal sample, LT or infected, it goes to the Canadian
Food Inspection Agency. It’s not us. Again, monkey sample, it’s the
same thing, but on top of it, we for most of the samples
— monkey samples — it also needs a scientist
permit that is given by Environment Canada. Experimentally infected animal
samples containing a human pathogen, it would be us. Why? Because I said
before, the exclusion is for naturally occurring sample. This is not natural. It’s someone spiking an animal,
and therefore we cover it. Okay, so in Canada,
since December 1, 2015, and that’s actually
on December 1, 2015 that this biosecurity
portal went online. I was kind of scared that they
making sure everything would go as fine as possible and
it did so I’m pretty happy that my teamwork worked
hard to make it work. Canadians that are working with
human pathogens now have to come through the Biosecurity
portal to apply for a license and get a license. The other things that
they’re allowed to do through this portal
is also reporting. So report notification for different scenarios
including lab acquired infection. One of the features that we wish
to have and it’s not there yet, actually it is there, but
only for biosafety officers. We would like to
have it external so everyone can consult it,
its biological agent research, which means searching
the database and learning about our risk groups. A lot of people are
asking for that. So we went from paper
based, having ten or fifteen rows of
cabinets — yeah. And that’s just for two
years’ worth of stuff because we archive everything
every three years, to this. So now, in after nine months of running the program I can
say I probably have passed five or six little ole post-it
sticks, and that’s it. No other paper. So I use the post-it to
go across, see a friend, see a colleague and
ask questions and that’s pretty much it. We don’t have paper anymore. The only thing that’s
not submitted through this portal is
anything that relates to security sensitive
biological agents, obviously for security reasons. The portal is protected B. So obviously secret
information is not given there. So these are received by paper
by the other group that works with me, and they
handle it appropriately. But for everything else, license
applications, everything, it all comes through the portal or through e-mail,
which is fantastic. Okay, this is my busiest
slide, but you see it’s not that difficult to understand. So like I talked before, we
assess pathogens by risk group and when we decided to create
the licenses we also looked at the risk based approach for
our pathogen and toxin license. So, we have four main categories
of licenses, risk group two, SSBA toxins, risk group
three, and risk group four. And we have assigned
different length of time, validity periods
for those licenses. So for a risk group two
license which may or may not, depending hat the
people are doing, include toxins or prions. We are allowing them
up to five years. So the license will be
valid up to five years. During that period, we will
either audit them, inspect them, or different mechanisms
to verify compliance. Security sensitive biological
agent, the toxins ones, they own their own license
because they don’t really fit in any other categories., and
we really wanted them to be in similar validity period
than the risk group three. Risk group three and risk group
four they have a validity period of three years for
risk group three, and one year for
risk group four. And again, the number of
years does relate to the risk. You can see in red, the three
arrows in red, they all refer to the fact that these specific
ones need secret clearance to be — like the people working with these samples will need
secret clearance to access part of the facility where
the SSBA’s are present. When — and every
time I say SSBA, in your case it would
be select agents, or almost the same thing. We might have a couple
of little difference. So the risk group three and risk
group four license, with SSBA, it’s not a different license, it’s just that we add extra
conditions for secret clearance. So one of the things that we
also looked at when we looked at the risks is —
and I’ve realized that through the years
doing inspection, is people doing science,
scientific research, it is a bit more
risky, just by nature. The nature of doing research is,
you know, working to find things that are unknown and
going unknown, you know, that could be the dark
side, some people say. By nature, it is more risky
because you combine genes. You don’t know what
it’s going to do. Will increase virulence? Will it decrease virulence? You don’t know. So we’ve decided
that people applying for scientific research, we
wanted them to submit a plan, and we call it the plan
for [inaudible] oversight of pathogen and toxin
in a research setting. Big name. But we wanted a plan to see how they would
medicate — how they would analyze
the risk, find the risk, and medicate the risk, and manage the risk,
more importantly. So that’s basically what we ask
for them, so it’s an added thing that we ask those
type of facilities. So the licensing itself, I put
some element there that relates to our licensing program. So an institutional license
will be required to conduct any controlled
activities with human pathogen and toxin unless they
are specifically exempt and you’ve seen the
exemptions before. Our license have conditions,
and it does depend on the scope of an institution
controlled activities. Each license has a
mandatory compliance with the applicable requirements of the Canadian Biosafety
Standards, your BMBL equivalent. The other conditions, we have
a lot of other conditions, but some of the other conditions
include not obstructing the biosafety officers work because
that’s something we’ve seen a lot of the time. Biosafety officers were
kind of stuck not being able to do their job properly. We also have requirement for importation transfer
and exportation. Like I said before, our licenses
are for different activities and these are included. So under the new
licensing system, there will be no longer
a requirement to apply or obtain an importation permit. And the next slide will show you
an example of our new documents. So that’s the first stage. A license is usually
four or five pages. If they have a lot of building
or sites, it may be longer because we list all the
buildings, all the sites. So you can see the
basic information and for most distributors
and most colleagues in U.S. that will be working
with Canadians, you should get the first page. There are some organizations
who’ve decided to provide the entire
document, and it’s up to them. But the other page may have
more sensitive information. Last week we just
realized that actually one of our license facilities
posted their license online, so it’s up to them to
decide what they want to do, but technically the first
page should give you enough information to be able to work
with your Canadian colleagues. So this example is for
security sensitive biological agent toxins. And you can see just below here, that little line
terrestrial animal pathogen. Canadian gets a two for one. So we’ve decided instead
of asking them to apply for animal pathogen
permit, and to apply for a license, to
put it all in one. So they come to Bio
secure portal, they answer all the questions and in the end they
get a license that covers human pathogen and terrestrial indigenous
animal pathogen. Which is why it’s not
called a human pathogen and toxin license. It’s called a pathogen
and toxin license. We removed the human
to make sure that it would fit both cases. And you can see the validity
period on the bottom there. So for people working
with Canadians, that’s an important factor. Make sure that its valid. We’ll come back later and
I’ll show you the next pages, but for now I’m just
going to step quickly to the Canadian Biosafety
standards which are our standards that
we use and actually again, we work really hard to make sure
that people will not have to — that people, Canadians
will not be burdened. So we work together,
two agencies together, Public Health Agency of Canada
and Food and Inspection Agency to create these standards. We have seen throughout
the years that sometimes that when we work inside
someone will ask a requirement and the other one will
ask a similar requirement but slightly different, and then
our laboratories didn’t know exactly what to do,
so we worked together in creating one standard. Again, that one world,
one health thing. And it allows us to monitor
and verify ongoing compliance of regulated facilities with a
license for control activities with human pathogen
toxins, or importing or transferring terrestrial
animal pathogens. We have created guidance
documents, handbook that gives more meat,
more information and details because these standards are
really the requirements itself. The handbook provides more
background, more rational for why we’re doing it,
and examples as well. And we are working also
on other guidelines. We are really eager and prone to help our relief
parties in Canada. We really want them to
understand and we feel that the more we help them, the
more we collaborate with them, the better they will comply. And our collaboration with our
stakeholders is really special, but at the same time, when we
have to act, and when we have to enforce, we do as well. So — and they are
aware of that. Technology 2016 means
you have to be creative, so we have created
the CBS Biosafety app, which is the standards
itself, but in an application that can be modified according
to what their working. So for example if the lab is
a BSL two lab, they can say to the app “I only want
to see the requirements for biosafety level two lab.” And I set it for — if
I’m working with rodents, or you know, large animals. So it creates a checklist
for them, and then they can just
take their iPod, go around and inspect and click, and put
notes and things like that. They can print. They can send it to us. They can do whatever they want
with it, it’s their tool now. Okay, now were going
to do back to the four, five next slides are really
what Americans should be seeing from our office. These are really the
regulatory documents. The documents that people will
use to show that they comply to our acts and regs and to show that they are able
to import or export. So, when we work with
the border officers, these are the documents that
the border officers would see. Again, it’s important
to say that we are in a transition period. You know, we passed the
regulation on December 1st, so we’re not there yet. In three months, because we
had the requirements for people to apply in three months,
so from December 1st to February 29th
we have received over 1,000 applications. We’re a team of five
doing licenses. So you can imagine the
number of files that has to be reviewed and everything. We’re not the only one
because we have inspectors, biocontainment inspectors. We have people around helping
us, reviewing those files, making sure that what
they submit is similar to what they submitted
before, but in reality, there’s not a lot of
people touching the button, like saying yes. So, we’re not finished yet, so that’s why you will
see different documents up until the end of December. So the first document is
the Importation Permit. That’s the former document
that we used to issue. It is now delivered
under the Health of Animals Act and Regulations. So what happened is
before the implementation, we continued issuing import
permits and they’re still valid until the end of this year. The second document, and
I’ll show you examples, it’s the letter to acknowledge
to receive an application, so again, like I said
everyone that applied between December 1st and February 29 received
a letter like this. The letter basically says
that they are authorized to continue the activity
until we say yes or no to their license. We didn’t want to
disrupt their activities. We didn’t want to
stop diagnostic. That was not our goal. Our goal is to improve and go to
the next — the better program, which is the licensing program, but we had to find
an interim solution, especially for custom officers. So we worked really hard
to create that letter. The next one is the
pathogen and toxin license. You already seen the
first page before, and that is the official
document that will be the one we
continue with later on. So, this is what an
importation permit looks like, or we can almost
talk in the past now. What you can see, basically,
it is an importation permit, so it’s not for all activities. You can see here, I almost
went on the French side, but the English side, Human Pathogen Importation
Regulations. That’s our former regulation that was repealed
on December 1st. So you should not see
a check mark there. If you see it, hmm, might
not be valid anymore. So the one you are expected to
see checked is this one here, The Health of Animals
Regulation. So after that, it talks about
the importer, the supplier, and it talks about the pathogen. Most of these permits
are pathogen specific, so we have written the
name of the pathogens, but as we were going on, the last few months we started
expanding and adding more. The second document,
the transitory document, it’s called The Acknowledgement
Letter. And actually, it’s not really
a letter, it’s an e-mail that the Biosecurity portal
sent, but I did print there for you to see the
text that is sent. And as you can see again,
it’s in French and English, and no I have not applied
for a license myself, but it’s just an example. So you can see in this case,
you can see the activities, for example, risk group
two pathogen toxin. You can see the date of
issuance and the expiring date, so that’s important
for you to know. And you can see this,
as you go on and read, that we are allowing them to continue existing activities
including import and transfer. The third one, you’ve
already seen the first page, the pathogen toxin license. I’ll show you the next page. Second page, you can
see that it refers to human pathogen and toxin. That’s the page that talks
about these organisms. And what you can see
is the activities. They are all listed there. The biological agent, in
this case, this is a license for toxins, so security
sensitive biological agent toxins. Risk group three and
risk group four licenses, you will see the agent
listed, or the toxin listed. For risk group two
license, what you will see, it will say risk
group two organism. Risk group two pathogen. We have decided to allow them
to bring any risk group two. Again, not to have to have
every week when you a pathogen or remove one because
you’re no longer using it. It’s all the same risk anyway. The way it is mitigated is through our containment
standards. Containment standards do have
specific requirements depending on the type — how
it interacts with us, how it affects us
and things like that. You can see the facility,
the type of work and the animal species. And a brief introduction
to the condition. Third page, it’s the
animal pathogen side. And the fourth page, fifth
page, would be the conditions. I didn’t put the
conditions there because it has no
meaning for you guys. It is meant for stake holders
and our regulated parties. That’s the end of it. In a nutshell that’s
our licensing program and where we are going. So it you have questions,
I’m sure some of you will have questions
because like I said, the exemptions and
exclusions is very different from other things being
done in the world. You can reach us through
the Center for Biosecurity. And we have two main e-mail: the
one for licenses and permits, so that comes directly
to my office, and then the general inquiries. Thank you.>>Thank you for sharing with
us the procedures in place for the import and export of
pathogens and toxins in Canada. We would like to
encourage our participants to please send your questions
to [email protected] Our next speaker is
William Stevens. He has been a Department of Transportation Hazmat
investigator for 19 years. Well versed in all aspects of transportation
rules governing all hazardous materials. His topic is transporting
infectious substances. Bill?>>Good afternoon. I hope everybody is awake after
a good lunch so that we can roll on with this presentation today. I’d like to obviously
thank Vaughn and the rest of the
staff around here, Diane Martin and several others, all the other agencies
for inviting us up here to be a part of this. This is probably my fourth year
or so, and I come to you humbly in saying this is probably
going to be my last. I’m looking to retire
the end of this year. But my experiences out here
with the CDC has been vast. It has been great. It’s been a wonderful
experience, so I just kind of wanted to pass that
along to everybody. I appreciate it. All right, obviously as Ms. Mueller has said, infectious substances is going to be our subject
today for the DOT. CDC and other agencies, y’all
regulate how it’s inspected, and stored, and secured,
and monitored and all of these things from the
person who is holding it, whether he is the
shipper or receiver. But the transportation phase
comes into under the 49 CFR. That’s why we’re here. How does it get there? How does it get there safely? And What kind of packaging and
communication is being done. Today we’re going to be talking
about this, but before I get into that one, I want to bring to your attention this
particular slide here that shows our infectious
substance pamphlet for shipping. I do have the work
guide underlined, okay? And that’s for a purpose. If you’ll notice
the top left corner, this document’s dated 2006. It is current for the
transportation rules, but there’s a section in
there that does list some, and I reiterate some,
infectious substances at a category A. Okay? They are not current. There may be some that have
been taken away from that list. There have been some that
have been added to that list. I do want you to use
this for a guide, but for specific cat A
material, I do want you to refer to the CDC and the eighth is
regulations USDOT etcetera. Do not use this as
it’s not in there. It is a guide. It is a very good guide. If you read this book and you
get into it, I don’t have to be up here talking to you today. That’s about the way it works. We do have an objective to meet
today in speaking with you. Provide an overview
obviously the 6.2 materials that you’re going
to be transporting. 6.2 is your cat A and
your cat B materials, and regulated medical
waste okay? We’re going to be talking about
some package selection today. What you should be using in
transportation, the marking, and labeling requirements,
the communication side of it. Shipping papers,
emergency response, information that must be
on there, and above all, your transportation
security plan requirement and hazmat training. If you do ship a select agent
that is regulated by one of these entities,
USDA, CDC, you will have to have a transportation
security plan. And I don’t care what
minute amount you send, or how many times
a year you send, whether it’s one
or 50 times a year. You must have a transportation
security plan, and we will be discussing that. We will also be discussing our
inspection processes rather quickly there, and then talk
about some top violations. I do have to extend
a congratulation to the people we’ve
been inspecting lately. Over the past years, we’ve
been having webinars. We’ve done inspections. Our inspections out there of your entities are
getting much, much better. We are coming back with
lesser and lesser violations because you’re listening to us. And that’s what we’re there for. You’re communicating with us. Of course, your category A
materials fall under UN 2900 and 2814 for the
animals and stuff. Notice no technical
name is listed in here. No technical name
when you’re talking about this Hazmat description. There are three elements
in there. Your UN number which
comes first, your proper shipping name, and then your classification,
6.2, all right? There is not technical name, and there is no packing
group associated with these. Category B, simple enough, UN 3373 biological
substance, cat B 6.2. That is the proper
description that should be on a shipping paper or package. This section right here,
please pay attention to it. If you go into the 49 CFR and
you will learn those sites up there as they are,
again, next time you’ll be up here speaking, okay? This is what you work by. This is your bible. 173.24 gives general
packaging requirements. I don’t care if it calls for a
UN package or a non-UN package, its general packaging. We want to close and secure
and have a safe transportation. All packaging would
fall under that. So you may have some
specific, then in 173.196, but you’re still going to
have some in 173.24, okay? 24 A, is requirements
for all hazmat. 24 ac is some changes that affected the infectious
substance and mixed contents. Okay? I.e., other
hazardous materials. There are exceptions, but
only on medical waste side. Regulated medical waste UN
3291, and that’s under 173.134 which tells us, hey,
we don’t have to use and infectious substance label if you’ll use the
biohazard symbol label. All right? So we don’t have to do
this one label type thing. Everybody, and it’s a
general standard consensus, they’re going to put a
biohazard symbol label on there, to also comply with the
OSHA standard, okay? Trying to communicate
our hazard. 173.196, learn that one well. That is your requirements
for category A shipping of infectious substance. Is category A select agent
a different category A? No it’s not. It’s a step up, but it’s
still category A. We’re going to keep things simple in
the transportation world, as category A or
category B. Okay? Naturally category A is
going to put you there. it’s going to kill you. It’s going to make you
very sick, etcetera. Category B is a lesser
element here. But, with category A,
we do not identify, that we have a select
agent in that package. Or on that package. Where do we identify
the select agent? By CDC form two, which is
located inside the package for the receiver, because
they’re the only ones who have a need to know. We’ll get to some
of that later also. Regulated medical waste,
173.197, when I go to a facility to inspect, you’re going to get your dollar 298
worth when I go there. Because I’m not only
going to talk about infectious substance
category A, we’re going to talk about cat B. We’re going to talk
about regulated medical waste. Guess what else? I’m going to go over here
to your chemical waste side, and we’re going to
talk about that. Shipping papers, communication,
package selection, etcetera. You’re going to get
your dollar 298’s worth. Okay? Good tax dollar
man here, by the way. Cat B is 173.199. This tells you packaging, the
communication, all of these. The package selection
and what it should meet as far as requirements. Testing UN packages
or not testing, or having a capability test. Of course 178.609 is
your package testing for your category
A materials, okay? It is very stringent and
I’ll show you some of those. This obviously is what a
category A package looks like, and essentially putting in
here, it is a triple pack. It is your vial that’s closed
and sealed with a stopper, a wire, a tape, something
to keep that material, the slat the auger, whatever
it is, from coming out. If there is a liquid in there
you will have absorbent material around it, okay? Do not put a bunch
of vials inside of a package like Pixie Stix. I have seen that. It is not fun when you see 100
vials in a box, in a container, and you’ve got caps
off of them, okay? Because they’re in
there like Pixie Stix. It will go inside a
secondary package, which has to be leak
proof, okay? And of course, absorbent
material if necessary. The list of your contents, i.e.
your form 2 from the CDC goes between the secondary package and the outer package
for the receiver. He knows what’s coming, and
now he’s got an inventory sheet of it, but nobody else
needs to know that. And of course that is
all put inside a box that has the UN designation
on it. It starts out in a circle
with UN in lower case letters, and then the classification
beside it, and I’ll show you
that momentarily. So we have a triple pack. We have foam absorbent
material inside of it. We have an inner
package, we have a list of contents, outer package. That is a certified package. These packages, 99.9% of them
have some printed information on one of the flaps. That is closure information. You as the packager must have
function specific training that you know how to close that
package and have done it before, and it needs to be documented. It’s called function
specific for closure. You follow that. It even tells you which flaps go
down first on a four flap box. One, two, three, and four, okay? Following, if you
get a test report. If you’ve got boxes
that are five years old, can you still use them? Yes. As long as you have
the closure information and you’re doing it correctly,
which hopefully is able to be read on the box, okay? And the box integrity
is not suspect. It will go through
transportation there and back, and there and back, and this box
starts to show wear and tear. Okay? Package integrity
is very important. When it gets to a point
where you’re looking at it and you’re trying to decide. If you’re having to try
to decide, get rid of it. Get you a new box. Get you a new box. This is what your UN
string looks like. This is what it represents. The 4GU, tells me
it’s a fiberboard box. The U tells me that there was
different primary receptacles in here. We put a U in there,
just like we put a V on some other type boxes
for a variation test, which means we tested it with
something very fragile inside of it, and we tried to bust it. And I’ll show you the
requirements for testing, and you’ll say whoa,
pretty serious, okay? But, if it will take — if
they test it with a glass vial, or something very fragile,
and it passes the test, then it can use this
U designation. And we usually reserve that for
packing group one materials. For regular, other packages
that don’t show class 6.2, it would be a V.
But it’s only used for packing group one materials. Okay? Your class
6.2, that tells us that is an infectious
substance package and that’s the only material
you can put into this box. I can’t put acetone in here. one gallon can of acetone
in here and ship it, okay? It is not for that. If it was for an acetone,
it would be marked 4G, and let’s use V as an
example, and then slash Y for practical group two. Whoop, we just messed up. It’s got to be an X. X,
Y, and Z marking equate to a packing group one,
two and three marking. X is one, Y is two, and three. Okay? So, it would be
marked 4GB slash X, and then it might be ten,
which represents ten kilograms of weight that that package
and contents can weigh. But that’s for other
hazardous materials, not for your cat
A materials, okay? Your year of manufacture. You notice this one says 06. Can we still use that? Yes, we can. As long as you have
all the components that it originally came in, you have the closure methods
still able to be used and stuff. And when you tape these boxes
up and you rip off the tape and you tape them up and you rip
off the tape, guess what’s going to happen to the box layers
— paper layers, all right? Package integrity. And of course, It’s
made in the USA. The plus AA tells me it’s
a third party certifier. You made this box. You had it made strong
and this is the components that you’re going to have in it. Then you send it off to a third
party person to say “test it for me and see if
it passes the test.” That’s his designation
for the company, and 1869 is his test report
number for that particular test. I can call up and even
though it’s an 06 number, I can give them that, and
they’ll send it back to me in an e-mail real quick
like, and we’ll discuss about closure information
and inner packages that you may or may not have. Okay? Don’t take a plastic
bottle out of the box and then reinsert with a
small metal can of some sort. The kit has to be used as a kit. We cannot substitute. Testing of these packages. This is why it costs
so much for them. Okay? There’s not
too many people that make a class 6.2
package, but they can. Or I say make and manufacture,
and to go through the test. But your UN certified packages that will meet the
test under 178.609. We’re going to wet that box for
an hour, to represent it’s going to be a wet, rain type thing
to represent two inches of rain before we start
all of these tests. We’re going to take that box,
and we’re going to freeze it for 24 hours at zero
degrees, and do the drop test. We’re going to drop that
package from 30 feet high. Standard hazmat package might
be dropped from four feet. It might be dropped
from five feet. It might be dropped
from three feet. This one is 30 feet. We’re going to drop an inch and
a half diameter 15-pound rod on top of that box and see if we
can bust that vial inside of it. If the box is too heavy,
we’re going to drop the box on top of the rod, okay? It’s going to meet some
serious testing protocols. Of course, if it’s supposed
to have dry ice in it, they will put some in there
and anything that is used, they’re going to put
a like item in there if it’s written in
the test report. This box is suitable for dry
ice, and there’s a little box in there for it, and you
put the dry ice on top. They’re going to do it, okay? And of course, with
the U variation, which means we’re going to
do fragile inner packages, they may be fewer, they
may be even smaller, but since we gave
it the designation of U, you can do that. You can change that plastic
bottle to a smaller can. Okay? Metal can. You can do that. Its legal. It’s got to be marked
with a You though. Category B packaging. Essentially, this is
the same type package. I say essentially because it
is a triple pack all right? We’ve got the vial there. We’ve got the cap on it. Maintain everything. We’ve got the absorbent material if there’s liquid
involved in it. We have a secondary package
to make it leak proof. Okay? It can be a bag. It can be a box in there. And then the outer package. But note, that this one is
not UN certified and tested. It does have a capability
standard of being able to be dropped from four feet. That’s all, four feet, without
damaging the inner materials. It’s a cat B. We kind of walk around with cat B
stuff all the time. Then we have communication. Notice the package
mark label over there, the diamond with the 3373. I want to bring this out, and I’ll probably
bring it out again. Your label can be not less than
two inches on each side, okay? I believe that is 50 millimeters for you other non-standard
people. Metric. That always messes me. I’m an old guy. I graduated Riverdale. But it’s a minimum two inches. Does that mean you can
put a two-inch sided label on a box this big? No. If the box will accommodate
the size of a four-inch label, which is your standard
size label, then you must use
a four-inch label. If you subsequently have a
package that can be no less than four inches
on any one side, but you’ve got other information
to add to it, you are authorized at that time, to use a
two-inch minimum size label. I’ve seen this too
much in the past year. I’ll be honest with you. A lot of small labels
are being used out there on a large cat B package. Okay, the rest of it is
proper shipping name. Biological substance, cat B.
You’ll have the senders name, the telephone number so they
can get in touch with them, and normally all of this
is communication paper or information that’s
on the package. So you don’t have to
have shipping paper, unless it goes by air. Your cat B package, this is
the capability standard again. This is non-spec. Your only requirements
are listed in 173.199. If you only do cat B packaging, this is the only
training you have to do. Is in accordance to 173.199. Document that that person
knows the requirements. You’ve got to document it, okay? But that’s the only
training you have to have if you do cat B only. You’ve got a strong
outer package. Just like we saw on
the previous slide. You’ve got a triple pack. Its non-tested. You’ve got a capabilities
standard of, excuse me, from four feet. I said three a while ago. Primary receptacles
are leak proof. They won’t break. Primary. Your secondary secured
within the outer package. Outer package prevents the
release of the material. We’ve got a strong outer
package that’s not torn up. We’re using the good one, and
you’re marking requirements, the label size we just
mentioned, the name and address of person is on the
documentation or the package. You don’t need documentation if
you’re doing it on the ground, but you do if you’re
going by air. But let’s put the
communication of the person and telephone number on both. Liquid stabilizers, you’re
authorized one ounce of it in there without changing the
designation of the material, i.e. calling it formaldehyde
or something of that nature. But, you will have absorbent
material in that package to absorb the entire contents
of that one ounce or less of whatever you happen
to have in there. Put absorbent material
in that package. Package marking and labeling. Your marking is your
proper shipping name and UN identification number
That’s the first thing up there. The second thing is
no technical name. I want to see UN 2814 infectious
substance affecting humans, parenthesis suspected category
A infectious substance 6.2. Suspected category A
infectious substance. Under 301 B, we can do that. That is your marking
requirement, or labeling requirement. Your marking goes along
with your shipping paper of the proper shipping
name and ID number. Infectious substance label. I said that was one
of the exceptions under regulated medical waste, but we don’t have the
exception here for cat A, only for medical waste. We’re going to use the
infectious substance label that is current, which says
notify your local county health department, or state
health department. Don’t call the CDC, okay? They don’t want to hear
about every cat A out there that might have an incident. Okay? Orientation
arrows must be on there. They’re two arrows side by
side with a bar underneath. They must be on two
opposing sides. 99.9% of your cat A packaging
will already have it on there. Cat B, proper shipping
name, your UN 3373 label. Four inches all the time unless
the package is too little. Name and telephone number
of the responsible person and of course, orientation
arrows. These are your labeling
requirements. We have a label, and
we’ll talk, first one, on the biohazard symbol. Okay? We want that one on all of them except infectious
substance category A. That biohazard you’ll see
on your medical waste boxes. They may be non-bulk, which is a
container less than 119 gallon. Or they’re going to be on bulk. If they’re on bulk, they’ll
be on two opposing sides. Non-bulk you only need one side. Your infectious substance label, obviously for your
cat A materials. Your UN 3373, we
spoke about that one for your cat B and
your 3291 panel. It is not a placard. We do not placard a truck, okay,
for regulated medical waste, we put a label marking on it. They call it a marking. And this marking
here represented, is if you have bulk
containers inside. If the container is over
119 gallon, I don’t care if you carry it in one,
and a whole bunch of boxes, or you’re carrying a whole truck
load 150-gallon roll carts. They’re bulk containers
in there. Then the truck must be
marked with this orange panel and the biohazard
label on the left. Okay? It’s not necessarily
your responsibility to ensure if you’re doing medical waste. It is the transporter’s
responsibility, but there are some quirks about
this 3291 marking on there. Okay? We can put it on — you
can put a truckload of boxes of regulated medical waste on
this truck, and he’s maxed out, and he might weigh 7,500 pounds, but we don’t have
to mark that truck. Okay? Telling you that there
is a biohazard d in there. We don’t have to, but we can. Okay? Only one that goes above
8,800 pounds, and it is picked up from one source
and taken from A to B, would that truck have to be
marked with this markings on it? With the 3291 and the biohazard. Okay? From one location, if he stops at ten different
hospitals along the way, no, it’s not meeting
that requirement. Shipping papers. Category A, we’re going to put the identification
number on there, UN 3291. The proper shipping name, suspected category A
suspected infectious substance to meet the lost in the crowd. I have still run across some
persons over the past year that have insisted
to put that in there. Please don’t, okay? Technically it is not a
violation of the regulations, because we’re kind
of giving you an out. We’re working with the CDC,
but it is in the regulation, let’s take advantage of it because the transporter has no
need to know what is in there on a cat A package
— cat A material. All he’s concerned about
is this infectious. Let’s tell him nothing else. Okay? You’re not
lying to the guy, you just ain’t telling
him everything. The person who needs
to know is the receiver and he’s got the
information inside the box. He knows it’s coming. Hazard class. There’s no packing group. Type package, box. Whatever you’re sending it
in and the unit of measure. Shipper certification must
be signed, very important. Whoever signs that shipper
certification is saying, right hand up, I certify the above named materials are
probably classified, described, packaged, marked, and labeled,
and ready for transportation. Do not have the front office
staff sign these papers. They do not see the package. Okay? Plus, they have to have
documented hazmat training. Emergency response
telephone number. This can be your number because
you’re shipping this select agent, because they
know it’s coming. And its normally there in
a 24-72-hour time frame. 24-48. And you can use
that telephone on your hip. But when they call you at
one o’clock in the morning and saying “We’ve got
an incident out here, and what’s in this package?” You better be picking
that telephone up and have that information immediately. Okay? If you don’t want to do
that, then you should contract with an outside source to
provide that information. Chemtrel, Chemtrec,
Infotrac, etcetera, okay? Category B, no shipping
papers required unless of course it’s going by air and the pilot needs
to know about this. Because all the communication
material — information is on
the box, correct? Okay. Emergency response
information. It is for that first
responder out on the scene. He’s not all together smart or
anything, but he’s backing away and he’s saying,
“Hello Ms. Smith, I’ve got such and such here.” You better tell him what he’s
got, how to fight the fire. Does he evacuate
persons etcetera. What does he need to know? But it needs to be on the shipping paper
where it stands out. Let’s put this number —
emergency response number. Put your name down there
with the number on it and have it stand out, in bold,
in red, something where it — highlight it, to where
he can pick it up — when he picks up the shipping
paper, he sees it right away. And of course, it’s not required if you’re not doing the
shipping paper, but you’ve got that information on
the box for cat B. Okay, so we’ve talked about
packaging requirements, the marking, the
labeling, etcetera. A little bit about
emergency response. Transportation security plan. It is an easy enough
plan to put together. You already have a security
place with the CDC or USDA. You’ve got some elements
within that security plan that can cross over
to our regulation. Don’t make me go through
and read that whole document that you’ve got of 49
pages, or 100 pages of security plan information to
find out what I need to know. Cut and paste some of
that information out. Put it into another
tab, another booklet, and say this is your
transportation security plan. I am not concerned about all the
requirements the CDC has, okay? I do not have a need to
know for that matter. So, your plan is required if you’re doing any amount
regulated by the CDC, USDA. Your plan must include an
assessment of your risk. Risk assessment. While you have it in store,
while it is in transportation. What will you face? You’ve got to list these. You’ve got to address
personnel security. Unauthorized access
and in route. Personnel security. What kind of informational
gathering did you do to find out if this Joe Brown here is
a good Joe that you’re fixing to hire and let him work
with these select agents. I.E SRA, FBI checks,
all these backgrounds — tell us in this document. It’s going to be in your
other one, but I want you to pull it over into ours. Tell me what you’re doing
to ensure he is a good Joe. The unauthorized access. How are you going to
prevent unauthorized persons from gaining access? Yes, you can talk about your
cards, your finger print reader, your iris readers, your
padlocks and everything else, but if you’ve got in there that
the first person that I meet when I walk in as
a security man, and you say your plan says
everyone will present a photo ID, and they didn’t
ask me for one. You’ve got a problem. Okay? I’ve gone through
three layers of security to get to someone before. Nobody asked. They had a real good
training session the next day, by the way. Real good training. Okay, and then of
course, In route security. You don’t transport
this material. You are the shipper, but
you don’t transport it. How are you going to
ensure in route security? You really can’t, except for
going to the courier, and say, “Do you have an in
route security plan to ensure my product
gets from A to B?” And if he says yes, then you
can ask him to produce it. He may not produce it because
he may consider it sensitive information, but at least he
should give you a letter stating that he complies with the 49
CFR for in route security, okay? So you address it, that hey,
my courier has sent me a letter that says he complies with
— thank you very much. It is that easy. You don’t control it, so
there’s nothing you can do about it except confirm
that he does have one. Easy enough. Your job titles, your
duties, and the training plan. You must review this
plan annually. Which means you need to
document that annual review. If you change that plan, then
you must retrain personnel who have a reason to be
operating under that plan and have them document it. If no changes happen over
a three-year period now, that’s the period you’ve got
to retrain everybody anyway. Every three years. So it’s reviewed and revised as
required and looked at annually. Other training requirements. Hazmat training, general
awareness familiarization. All that is, is going through
part 172 in our regulation that shows how to
read hazmat table, how shipping papers should look,
marking, labeling, packaging. Gee, that’s the same
thing we just went over in the first part
of the presentation. Give them that training
and document it. That’s general awareness. Safety OSHA related
hazcom right to know. Function specific, package
closure, document it. Security awareness. Little bit different from your
security plan requirements, because this is just the
situational awareness type thing you want to bestow on a — you
get a guy who takes the package down to FedEx, or whoever is
going to carry it, and all, give him some situational
awareness training that says, “That red car’s been following
me every time I leave here.” Okay? Change your routes,
things of this nature. And of course, training involves
the in route security — the transportation
security plan, which will involve
other things too. I.E, what is your
objective of this? Anyone shipping infectious
substance must have knowledge and training. Easy. Last part here coming up. Compliance inspection. I walk in, this is
who I am, sir. You can invite any
representatives that you need to
be here and all. Let folks know up at
headquarters or whatever, that we’re here doing
inspection. I will introduce and tell you
what we will be doing today. I’ll tell you the purpose. We’re going to tour
the facility. We’re going to talk
about those three items, your dollar 298 worth. We’re going to talk
about packaging today. We’re going to talk about
your bills of lading. We’re going to discuss your
training covering those three items, again, your
security plan. And then I’m going
to walk you out and give you an exit briefing. If I do not find any
noted violations and such, I’ll be glad to give you an
Okay and walk out of there, and that’ll be the only piece
of paper that you get from me. Otherwise, as I go through
my inspection and looking at all these things, I’m going
to tell you what I am looking at and questioning, so
that you’ll understand. And I’m going to tell you in
the regulation where it’s at. Then I’m going to write down
violations too, and present it to you at the end, describe
it thoroughly, show you how to fix it, and you’ll
have 30 days to do so. Show me back in writing
that you did. Okay? That’s the
quick down and dirty for a compliance inspection. I’m in, I intro, I do the
inspection, I come out, write violations or not write
violations, but you will get at least some paperwork from us. The top violations, training. Training is still
hitting the top, okay? Everybody knows you’ve
got to do the training. The security plan requirements. Sometimes people don’t
have enough information the in route portion. Sometimes they don’t comply with what they actually
have written down. Okay? We’ll be looking at them. We read them. We read them. We’ve done, and this
number’s low right now, more than 300 inspections
since 2008. That’s quite a few inspections
and entities we’ve been to. And that includes
re-inspects also, if you had a problem before. But I’ll be honest with you, just at the very
beginning I said, you’re doing so much better. So much better because
of webinars like this presented by the CDC. Our communication. I’ve done them in other areas. Infection control persons,
universities, etcetera. You’re getting so much better. Last couple of years have
been great, by the way. Just to let you know
about that one. We do have an info center in
DC, 1-800 number up there. Please call them if you have
any questions whatsoever about what you are doing. Don’t send it out saying
maybe this is right. If you want to talk
to someone, call them. They will help you. They’re knowledgeable people. There are people who wrote
the book in that office. There are people who
are attorneys in there. There are people who can
research interpretations. They are there for you. Okay? If you don’t like
them, you can call me. Easiest way to get in
touch with me is by e-mail. I do work from my house. Downtown Atlanta gets a little
crowded, but by all means, contact me via e-mail and I
will help you wherever I’m at. I do travel a lot, but
I will get back to you, preferably that evening,
at the hotel, okay? So with that in conclusion. Call me, call the office. We have very knowledgeable
investigators there that know the same
subject matter. I’m no better than they are. I just happen to be the one
that gets to raise the flag. Okay? With that, I appreciate
it very much, thank you.>>Thank you very much for
the very informative talk. The next speaker is
Kimberly Cressotti She’s the import/export
consumer safety officer, import compliance
programs within the center for biologics Evaluation
and research at the FDA. Her topic is importing and exporting CBER
regulated products. Kimberly? Thank you very much
for that introduction. Good afternoon everyone. I would also like to
thank CDC for inviting FDA to this webcast, so
thank you very much. I wanted to talk to everybody
today about the importing and exporting of CBER
regulated products. CBER regulates biological
and related products. My center, the center
for biologics, evaluation and research, is one of
multiple centers within the FDA. We have centers for devices
and radiological health. We have a center for tobacco,
a center for drugs, evaluation and research, a center
for food safety and tide nutrition
just to mention a few. CBER’s mission is different from
the other centers in that we aim to ensure and protect the public
health by regulating biological and related products
such as blood, vaccines, allergic acts — allergenic
products I should say, what other things? Tissues, and solar
and gene therapies. Unlike some of the chemically
synthesized products, biologics are basically
manufactured from living source material,
such as human material, animal material,
or microorganisms. Therefore, we developed a
comprehensive import program to educate others on how
to import these products. Our goal in writing this program
was to help to, of course, ensure and protect the public
health, but also to aid people in facilitating their —
the import of their products into the United States. Where FDA gets their import
authority is in Section 801 of the Federal Food,
Drug and Cosmetic Act. And basically this section
sets out the basic standards and conditions for entry review. However, where we get our punch,
or our main authority to refuse and refuse admission based on
the appearance of a violation of the FD&C Act is
Section 801 A. Next slide here is just to
show you an idea of some of our products that we
have, and also to show that CBER products
in the grand scheme of things are very small
— a small grouping. It’s less than one
percent of all FDA imports. Even though there are small — these are small in
volume making entry. They do have some special
circumstances and conditions. And one of those is that,
since they’re living — they’re a living source, they are highly temperature
sensitive. So let’s talk a little bit about
our CBER compliance programs. We have — first we have the
compliance program guidance manual 7342.007. And basically this program
is for the importation of biological products, drugs
and devices that are regulated under Section 351 of the
Public Health Service Act, which is our licensing
provisions. And Section — and
general the FD&C Act. We added an addendum to this
compliance program to explain and provide guidance on the
importation of cells, tissues, cellular, and tissue
based products, which we basically call HCTPs. And these are regulated
under section 351 and we have created regulations under 21CFR 31217
— no I’m sorry. 21CFR part 1271. Section 361 of the
Public Health Service Act, is basically a provision that — That we use to stop the the spread of communicable
disease. SO for tissues, we’re
basically looking to make sure that if this tissue or HCTP is
imported, we want to make sure that it does not
contain infectious agents and so we would like to
see information on that. And as I said earlier, we do
have some special circumstances. And these circumstances include
samples, biological specimens for research testing,
blood and blood components for autologous use, and the
import for export provisions. These special circumstances
may not have to meet all of our export requirements. Pardon me. So let’s first — I’m going
to grab a glass of water here. So let’s first talk
about samples. We see samples making entries–
entry that are basically drugs or devices, and they come
in for testing in vitro. Or for laboratory
testing in animals. Drug products that are shipped
for investigational use need to come in under 21 CFR 312.160. And these products do require
a cautionary statement. Cautionary statement
reads something like, “Contains a new drug for
investigational use only in laboratory research
animals or for test in vitro. Not for human use.” Blood grouping re-agents,
re-agent red blood cells and anti-human globulin
for investigational in vitro diagnostic use must
also comply with 312.160. Devices, which we also regulate
some of, are intended — that are basically
intended or — in vitro use or in
laboratory research in animals, also have to comply with 21
CFR 812.5 C. And shipments of in vitro diagnostics
for other research and testing purposes
can be shipped if they meet the
labeling requirements in 21 CFR 809.10 C2. I have to laugh. This is one of the
most unique sections, and it’s always something that
we look forward to in our office because we get so many unique
and bizarre items coming in. Biological specimens
for research. And just because they’re
biologic in nature, I guess, that’s why we’re called,
but biological specimens that are not routinely
subject to FDA jurisdiction. Basically because
they’re used for testing in a clinical laboratory or
for basic scientific research. They’re not intended for
the prevention, treatment or diagnosis or cure
of diseases or injuries or conditions in humans. And lately, we’ve had
a couple of inquiries from the industry concerning
harmonized tariff codes and the ability to
disclaim for FDA review, certain clinical
specimens and re-agents. We heard industry and
we have worked with CBP, and we have now have, actually,
four harmonized tariff codes. The new one, I don’t really
know off the top of my head, but I just wanted to make you
guys aware that there is one. And if you need to find
out more information about biological products,
please go to the link below on the slide, and that should
provide you everything you want to know about biological
specimens. Another special circumstances
would be blood and blood components
for autologous use. Blood and blood components
for autologous use are subject to licensure, however, based
on the world and travel, and everything, and that here in the United States we do
have some specialized surgeries that are performed, some
individuals are coming to the United States to
have surgery performed. And they want to
have their own blood, so what they do is they donate
their own blood for later use to be reinfused into themselves. And FDA of course, does not want
to hold up somebody else blood for surgery, so we’ve created
this special circumstance. However, we don’t want to see
somebody shipping blood products on a routine or regular basis. And we don’t want to see that the product has
been further processed or incorporated or manipulated
into something else other than transfusable blood
or blood components. In addition, it needs to
be appropriately labeled. And if you want to see more about the labeling requirements,
please see 606.121. Another unique situation
that we have is the import for export provisions. This provision in the act
allows for the importation of unapproved product or a product does not
meet our FDA requirements or the FD&C Act to be imported. However, you cannot import
it unless it is going to be further processed or
incorporated into a product for export by the
owner or consignee. And it’s a two-fold process. Once you import it,
you further process it, and you incorporate it into a
final product to be exported, you have to meet
one of our export — legal export mechanisms, which
are section 801 E or section 802 of the FD&C Act or the Public
Health Service Act, section 351. Import for export is unique
and it actually has two types of scenarios for the
import for export. One is for 801 D3, which is
basically for drugs and devices, and section 801 D4, which is
for blood, blood components, source plasma and
source leukocytes. Each one of these import for export scenarios have
different criteria, but 801 D3, we basically want
to see a statement that confirms the intent for
the process, such article or incorporate that article into a product that’s
going to be exported. And a statement that identifies
all the entities in the chain of possession of the
imported article. 801 D4 on the other hand,
is actually still has to meet the requirements
of 801 D3, however, it’s an application process. When this provisions first
came into play, there was a lot of questions and
anxiety, I guess, or concern over blood products
being imported into this country that could possibly be
diverted into our blood supply, or be diverted for
another type of use. So, we wanted this application
process to be in place because we wanted to
know what was coming in, how it was tested, if it was
going to cross contaminate any of our product — our machines,
our equipment that we are going to be using for our
US approved products. And so we would review it,
we would approve it. You cannot bring in anything until that application is
approved We would issue an approval letter and that — that is something that
you really should include in your import documentation. The reason we really
want it to be there is because if it’s not
there, it might be viewed as an unapproved product,
maybe detained, refused or even possibly destroyed. As those out there know, and
that have been doing imports for a long time,
there are instances where information is
transmitted, or given to us, and its incomplete,
or its incorrect, or there’s not enough
information. It’s not clear. So, FDA tries to ask
for, or will ask for, such things as labeling for a
product, short supply agreements if they’re in place, the import
for export approval letter that I just spoke about,
documents that are required by other agencies
such as CDC or USDA. We’re looking for those permits. In addition, we’re also
looking for accompanying records which is a requirement
for our HCTPs. I’m going to switch
gears here a little bit and talk about exports. I just wanted to mention here
that, as I mentioned before in the import for export
provisions, you have to export that product using one of
the legal export mechanisms. So and you can also use these
export mechanisms separately. They don’t have to be used in
the import for export solely. So, we have the legal
export mechanisms of 801 E, as I mentioned before
and 802 of the FD&C Act, 351 in the Public
Health Service Act, which are our licensing
provisions, and 21 CFR 312.110 which is basically
for the export of investigational products. I’m basically going to generally
cover these export mechanisms. So, the first one I like to call
the simple notification process. And this mechanism is used for
the export of drugs, devices, food cosmetics, that are
adulterated or misbranded under the FD&C Act to
meet specifications of a foreign purchaser. To not be in conflict with the
laws of the importing country, we need to be labeled. And the outside of the
shipping package label, that is for export only. And it cannot be sold or offered
for sale in domestic commerce. The next provision, or the
next export mechanism is for the export of
basically unapproved devices. That don’t — that don’t
meet the requirements of the FD&C Act, or
exempt and FDA has to make a safety determination
and we have to determine that it’s not contrary
to public health. And this is also an
application process. An application process,
which we will have to take a look at safety data. And we’d also like to take a
look at any data or publications that are available to show that
this product is not contrary to public health and safety. I just want to mention,
too, that when we’re talking about the listed countries, these countries were
not picked by FDA. They were picked by
congress, and it was based on whether the country
had statutory or regulatory requirement
or regulations in place that allowed for the
review of drugs, devices, biological products for
safety and effectiveness. For GMPs if they had
some form of GMPs, that they had the ability
to gather adverse events and pull products from the
market if they were found to be unsafe or ineffective. And they also wanted to make
sure that they had some labeling and promotion regulations. So I’m going to move
on to section 802 here and these mechanisms are
a little bit different. I think I’ve gotten
ahead of myself. Did I go backwards or forwards? Okay. This mechanism I call the
simple notification process. And basically these get
a little more complicated because they have to
be manufactured in GMP. So how do you evaluate GMP. Well, we have to have some
type of inspectional history to know whether the US
manufacturer has GMPs in place. This first mechanism is
for the export of a drug, biological product, or
device to any country. As long as they have valid
marketing authorization these listed countries are basically
the EU, the EEA, and Australia, Japan, New Zealand to name
a couple of the others. So, this is what I call the
simple notification process. Basically what you’ll have to
do is provide a notification to my office and telling us that
basically what you’re exporting and where you’re
exporting it to. 802 B2 is a little
bit more complicated. This one, we don’t use very much because the bottom line is we’re
basically evaluating a foreign ministry of health’s
regulations. And basically it’s the same
items that Congress used to evaluate whether a country
could be a listed country. So you know, it’s the GMPs, it’s
the adverse event reporting, it’s the promotion and labeling. So, were going to have to take
a look at that and evaluate it and we don’t use it very much. I mean, it’s very hard
and complicated to try and get something translated,
first of all, and then compare, you know, our regulations against somebody
else’s regulations, so it can be complicated,
and we very rarely use it. In addition, it’s
specific, it’s very specific. Its specific to a
specific product or drug or biologic device. Oh I’m sorry, devices don’t
fall under this category. But, so, it’s centered around
that drug and its indication for use, or that biologic
and that indication for use, and that countries,
you know, authorization to allow it to come in. So it’s very direct, you know,
you can’t just add on to it. Then we have two other
export mechanisms. If you can’t meet the
criteria of either 801 A, which is simple notification,
or 802 B, then you have one more
option, which is 802 B3. And this basically allows the
export of unapproved product, or an unlicensed
product to be exported to an unlisted country
based on scientific evidence that is reviewed both b FDA and
the Foreign Ministry of Health to demonstrate the products
would be reasonably safe and effective for
its intended use. These are situational
and specific and pertain to the specific drug
intended for export. This is also an application
process that would need to be reviewed and approved by
the agency before you’d be able to export the product. In addition, you
would need, of course, valid market authorization. 802 C is one of the
provisions under 802.4, investigational products. This is used for drugs,
biological products and devices, and it’s for the shipment of investigational product
to listed countries. Section 21 CFR 312.110 basically
spells out the export provision for investigational
drugs and biologics. However, sections 802,
as I mentioned before, can be used for devices. You can export a product
to an unlisted country if it’s being exported to
a person that is listed as an investigator in the IND,
and that product would move under and effective IND. As I discussed earlier, you
can also use FDA section — I mean, FD&C Act
section 802 B 1A, the simple notification process, to export investigational
product. As I mentioned before too, 802
See, which is investigational to listed countries, and
we also have two new things that we haven’t talked about. And these are, if you
want to export a product, investigational product
to an unlisted country, we do have the provision
21 CFR 312.110 B4. And this is basically a
certification process telling us that you’re going
to meet certain certain regulatory criteria such as the basic export
requirements that, you know, the products going to
accord to the specification of the purchaser, the
foreign purchaser, you know, it’s not contrary to public
health and safety etcetera. And that is provided
to our office of international programs. The last item for investigational products
is a section that allows for a national emergency. And this section will allow
for the export of a product for emergency purposes or a foraging emergency,
national emergency. We’ve used this for the
Ebola crisis where — and we’ve also used it in
other circumstances to be able to stock pile product. And the last export
mechanism I’m going to talk about is the export of a partially processed
biological product. And this can be found
under section 351 of The Public Health
Service Act. And basically, this is the
export of a biological article or product that would require
purification, inactivation, fractionation, or significant
chemical modification to be done upon it before it is
exported into a final product. It cannot be in a form
applicable to the prevention, treatment or cure of
disease of injuries of man, and cannot be intended for
sale in the United States. And the bottom line here is that
we didn’t want to hinder trade, and we didn’t want to
hinder collaboration efforts with overseas firms. So we wanted to allow them to
be able to create a product from like a cell line or a
certain material that is unique and they want to further
process and create a new product over in their country. That’s basically it for me,
but I wanted to list all of the people that are available
in my office in the division of case management that
can help you at any time. But I want to mention that the
best way to get ahold of us is of course by email, and that is
at CBER[email protected] and if you have any questions
feel free to e-mail us. And I also wanted
to show you the link at the bottom of the page here. This is our import
and export website and that should provide you a
lot of additional information and talk about some of the
things a little bit more in depth than what
I’ve discussed here. Thank you.>>Another reminder for our
registered participants, please send your questions
to [email protected] Now to our final speaker,
Brent Davidson. He serves as the Chief of
the International Assistance and Response Policy Branch
where he analyzes, evaluates, and develops policies on international health
security associated with legal, regulatory, and logistical
challenges to public health emergency
preparedness and response. Mr. Davidson?>>Thank you Lourdes. Good afternoon, good
morning, wherever you may be. All right, so I am
the last speaker here and I’m also unlike
those who came before me, going to have a little
bit presentation. I’m here from the assistant
secretary from preparedness and response and we are
not a regulatory body, so we’ll be a little
bit different than the others in that respect. So I’m here to talk a little
bit about our experience in sharing biological materials
during public health emergencies and then a little
bit more specifically about our permitting experience
for this audience in particular. So you may note down there at
the bottom that I am lawyer, which may make you wonder
what it is I’m doing here. But I will assure you
that I’m not really much of a lawyer’s lawyer, in fact,
last night I was watching a bit of Law and Order and
it occurred to me that Sam Waterson might
actually know more about the law than I do. Especially in the ways
that its important, so. Okay, so what am I going
to talk about here? I’ll introduce ASPER,
the assistant secretary for preparedness and
response a little bit and tell you how we’re
involved in this space. Sort of go over all
the A to Z challenges that we have identified when
it comes to rapidly obtaining and sharing materials that are
related to pathogens involved in public health emergencies. Give you a bit of our experience
specific to the Zika response and then tell you what it is
that we’re going about it. So, the office of the assistant
secretary for preparedness and response is meant to have
sort of a coordinating role in leading the nation in
preventing, preparing for, and responding to
adverse health events and health emergencies
and disasters. And in specific in the
international space, we lead the coordination
of those types of efforts as they occur internationally. So, the things that
we like to say here, global is the new local, right,
especially when it comes to many of the recent responses
that we’ve had that tend to be infectious diseases. So MERS, Ebola, Zika, that
is what’s in the front of our minds these days. And of course, when it
comes to these sorts of infectious disease
responses, rapid action is key to preventing, mitigating
these sorts of threats. So this is not something
I think I need to tell this audience too much
in detail, but needless to say, receiving samples and other
types of material related to pathogen that are causing
a public health emergency are critical for all
sorts of research. Depending on how much we know or
don’t know about a novel threat, we may need to be conducting
natural history studies. We may need to be conducting
epidemiological studies, or we may need to be
developing diagnostics, vaccines, and therapeutics. Most likely we’re doing all of
these things at the same time. So, clearly the research and public health communities
need material in order to do this, and without that material we have
a hard time finding out where the virus
is, what it looks like, where it’s going to be tomorrow. So this is of course, there’s
more details to be filled in in all of these steps,
but this is sort of the A to Z issues that we
encounter when we’re working to acquire biological
material and then share that onward if appropriate. So, you know, we’re first
we’re acquiring samples, and that’s literally just
the process of identifying where in the world or in the
United States we can obtain those samples. Coming to terms on the
material transfer agreements or simple letter agreements that
is going to accompany those, which is a general sense
describes what you can do with those materials once
I transfer them to you. We then need to obtain
the permits and compete all the necessary
paperwork as you’ve heard here over the last couple days. Make sure that we are packing and shipping these
things correctly. And then organize ourselves
to receive these samples and distribute them onward in
the United States, if need be. And so, challenges to rapidly
sharing during emergencies, right, you see that in hot
pink there, the rapid part. You know, what about these
situations is different that makes them unique? And so broadly speaking, right,
there’s likely to be caveats and exceptions to all of
these things here in the list, but generally speaking, when
it comes to international law, or international
regulatory frameworks or even domestic laws,
there is not a lot of policy that addresses the
need to share things on an emergency rapid basis. Particularly for non-influenza
samples, and we say that and Ill touch on
this a little bit. There already exists a
international agreement that addresses how we share
samples of pandemic influenza that may be circulating
in the world. So we sort of take that
out of the equation because we already have a
well-defined system for that. So, again, in a general
sense, you’ve heard through the last few days, that
there may be a few exceptions to this, but generally speaking,
there’s limited flexibility in adapting to emergency
situations, right? So for normal research processes
you would get a institutional review board approval to
conduct a certain type of research right? A process that generally
isn’t done in emergency basis. That’s a thoughtful
considered process that an institutional
organization would engage in to think about the research
that’s about to happen. These types of negotiations about material transfer
agreements or obtaining import and export permits aren’t
necessarily established to work on an emergency basis. Right? These are — no one’s
life is generally in danger when we’re talking about
transferring these things. And depending on what
we’re dealing with, we may have delays related
to confusion or ambiguity about the type of
biosafety/biosecurity that will be required
for the agent. Or how dangerous it is, right, because we simply may not know
the answer to that question. We may not know if
it’s zoonotic. We may not know exactly how
its spread, so those sorts of things tend to
result in delay. And so, as Lourdes
mentioned in my introduction, generally we sort of bend these
things in legal, logistical, and regulatory buckets. And we find that most
of the challenges sort of fit in those categories. So in no particular order here,
patient privacy and consent. This is a challenging
issue for us because when you’re
collecting samples of what may be a novel pathogen
or something that is novel to a particular population, you
— certainly the initial samples that you collect aren’t being
collected with the mindset that we’re then going
to do research on them, or that they would be
sent out of the country that they’re collected in. Right? They may be discovered
as part of diagnostic tested on another related disease. Maybe something that’s picked
up through blood screening in a population and you may not
even know the person has it, right? As we’re finding with Zika,
right, a very large number of people are asymptomatic. So you may not even —
you may be finding things that you didn’t intend to. As I mentioned, a lack of
international agreements to share non-influenza samples,
so some people are familiar with the international health
regulations which does, sort of encourage
international cooperation, but it is not binding and it does not specifically
address the sharing of samples, so there is no way to
regulate or enforce this. Here you see the WHO
pandemic influenza preparedness framework and that, as I said, sort of takes the influenza
samples sort of out of our — this immediate realm
of consideration. Access and benefit
sharing concerns. This is sort of an odd
term of art when it comes to international
sample acquisition. This comes from the idea that the countries
may exert sovereignty over genetic resources that
they find in their country. And this comes from sort of a
wider discussion about the use of resources in countries
and whether or not those should
leave the country. But part — that gets
swept up when we’re talking about pathogens and
novel genetic resources. Separate but related
are questions about international
property rights. And those are always present. A key step for us to get
from not having diagnostics or vaccines to having
diagnostics and vaccines is to move those samples from
what may be an academic or research space, or
public health space to commercial developers. And that’s certainly true in the
US system where we don’t have on our own, and end to end
capability to develop drugs and bring them to market. And so, at some point, if
we want to have those tools in large numbers, there
need stop be that jump to the commercial space
and when that happens, when we have those
conversations, those intellectual property
questions can be challenging. The Nagoya Protocol that’s
something you can look up in more detail
in your own time if you’re having trouble
sleeping, but it relates to this access and
benefit sharing question. This is a specific international
protocol that’s meant to address these issues
of if you are going to access these materials
in my country, then I expect to have benefit sharing
in return. The United States is not a
signatory to this protocol and some of our close
research partners are. And I will leave it there to say that that can create
some challenges. Courier policy. You may have seen,
I think, last year, that some couriers have
expressed their unwillingness to transport certain categories
of infectious materials. So it’s just always
important that you make sure that the courier is — that
you have an identified courier that’s willing to transport
whatever it is you’re asking. So moving on to the
regulatory challenges right. Import export permits. Clearly there is enough
substance when it comes to regulation that we
have spent the better part of two days talking
about these things and all their different
facets and areas, so there’s clearly a lot there. And then if you magnify that
by all the potential countries where you may be
receiving products from, or sending products to, it’s sort of has an
exponential effect. Biosafety/biosecurity
current concerns. Packaging samples in accordance
with transport regulations and BSL classifications. Those aren’t always
consistent around the world. There may be countries
who have an interest in having a lower
BSL classification for a particular thing
because of the particulars of their geography, or their
country, or political pressures to not allow BSL 3 or 4
agents into their country. And so we’ve seen those sorts
of tensions in the past and — WHO is — it’s difficult
for them to respond in a timeframe that’s
relevant to an emergency to provide a recommendation on what classification people
should be handling those at. And then finally, the need
for people to make sure that the end user of the product
is authorized to work with that. Logistical challenges, so I think that this
has been covered right? The need for transportation
documentation, having all of our
paperwork together so that this isn’t stopped at
the border in a critical moment. Pilot refusal. At the end of the day, pilots
have pretty wide latitude to refuse to transfer
certain types of products, so particularly when we’re
talking about things again, where there may be
some ambiguity about how dangerous it
is, how its transferred, the pilot may have heard new
stories about a certain thing. That’s something that we
have little control over, but is an important
consideration. And then finally maintaining
samples integrity right. This is just sort to
of cold chain storage, and those sorts of things right? We don’t want — we want to make
sure that a product isn’t going to be sitting on
the tarmac someplace because there was no plan to
pick the thing up and it’s on dry ice, and that
dry ice is going away and we now have a
spoiled sample, whether it be entering
a country or trying to get out of that country. So, what have we
done to this point to address these sort
of basket of issues? So on the domestic side, we have
used in a variety of context, what we call the HHS, the Health and Human Services sample
sharing working group. So it’s a little misleading. Even though this is
an HHS led group, we always work very closely
with state department colleagues and others, the Department
of Defense when appropriate, so that everyone
knows what’s going on. And so we’ve used
that group to consult on domestic international
policy during potential or actual PHEICs, and that’s
a public health emergency of international concern and
that’s sort of a proper noun as declared by the WHO through
the World Health Organization — through the International
Health Regulations. We have also relied very heavily
on the import export tiger team, which is composed of the
speakers that you’ve seen over the last couple days
here, to consult them on permit requirements. Again, particularly in this
place where we may need to move faster than
we normally do, where there may be ambiguity,
where it may be something that we haven’t faced before. Internationally, we
interface with a number of international partnerships and initiatives including
The Global Health Security Initiative, this is the
G7 countries plus Mexico, and the WHO and the European
commission as advisors. The North American Plan for
Animal and Pandemic Influenza, The Beyond the Border
Initiative, which is a bilateral
initiative with Canada, and the Global Health
Security Agenda, which is sort of a broader initiative to
promote global health security with — among 40 plus
partners throughout the world. A variety of entry points
to discuss these things with potential partners in
sharing samples and moving on different pieces
from the technical level of exchanging information
about points of contact and permitting all the
way to the attempts to develop international norms
that will be easier for us to move materials like this
internationally in the future. So, moving to our
experience during Zika is sort of a little vignette
into these issues. One anecdote. SO in December of 2015,
here’s sort of the lay of the land as we knew it. We had this suspected
association between Zika and neurological disorders. We knew that the virus
was spreading potentially explosively in the
Americas, that we did in fact, have the vector responsible
for the spread here in the United States,
and we had no vaccines or therapeutics available
directly to respond to Zika. There was some materials in
the pipeline related to Dengue and other Flaviviruses but
nothing specific to Zika. For diagnostics we had some
CDC developed diagnostic tools, but there was no commercial
diagnostic capability that could be ramped
up very rapidly. So, what we did was we convened
this sample sharing group, and laid out our priority
needs as follows here. And so they were to
isolate virus in an attempt to give vaccine manufacturers
seed strains that they could then develop —
test and develop vaccines from. Next was obtaining
convalescent serum from patients that had been infected with Zika so that CDC could validate its
existing serological assays, and — which they
were then trying to disseminate down
to the states. And so states needed
these serums to be able to validate their assays
at the state level. We also wanted to obtain
additional convalescent serum to begin to send panels to
diagnostic manufacturers who had been working in
this space and thought that they might have some
diagnostic technologies that were — that
could be applicable, but they couldn’t test
them without the serum. And then, lastly, we were
also simultaneously looking for acute plasma for development of gnat testing for
blood supply. So this is a different test
that required, required rather than convalescent patients,
actually acute viremic patients. And so our available sources
for samples were at the time, a very limited number of US
travel related cases, right? People from the United
States traveling to areas where they then contracted
Zika and returning home. Of course, US territories,
namely Puerto Rico, but also Virgin Islands
and others. And then internationally,
Brazil, Columbia, and others. And lastly, biorepositories. These are either NIH contracted
companies, or private companies that operate biorepositories and
some of them had older strains of Zika virus from
outbreaks from decades past. And so they had some
older strains, but they didn’t necessarily have
the new Puerto Rico strains, or these other Brazilian
strains that were emerging. So, we were able to locate
initially, and as relevant to this case study, a
small number of samples from a partner in, we’ll
say the western hemisphere, that was already engaged with
us in a cooperative agreement on another matter and sort of
just, by happenstance almost, to have collected
some good specimen. And so if you remember the
sort of A to Z step chart, number one is to acquire — to locate but then
moving on we needed to negotiate the simple letter
agreement with the sender that would allow us to use
these materials in a way that was relevant for public
health emergency response. And so some key — some
of you may be familiar with the standard simple
letter agreements that are used to transfer biological
materials many, many times a day
throughout the world. We made some important
changes to those terms. One was to allow the
material to be used for any legitimate
public health purpose. Often, the agreements,
particularly among academic and the research sector,
will limit the use of the sample just a sort
of a boiler plate for — strictly for academic
or research purposes. And again, as I mentioned, we
needed to bridge that divide between academic
research and get these to commercial developers
to help us develop tests in a large number. Second, we removed
any restrictions on further distribution of
the samples or derivatives. And the reason for
this is that again, typically these simple
letter agreements will place restrictions on the
ability of a — the first recipient to send that
material on to another recipient without first returning
to the original sender, and getting their approval. And the reason this is so
important, particularly within the US government
context, is based on our very
large research and develop apparatus we
have in the United States, there is not a single
entity that researches and develops products
from A to Z. Right? It requires the
CDC, the NIH, the FDA, the Defense Department depending on the development
that’s happening and the forced protection space,
and so we didn’t want to be in a situation where one of those entities could receive
the sample but not be able to transmit it to
another federal partner. So, moving on to the next
step where once we were able to develop a simple letter
agreement that allowed us to get those materials
in under this sort of, public health emergency
response mindset. We then worked with the
folks you’ve seen up here, through what we call
the Tiger Team, to help us identify the
permitting requirements that were necessary
to get these materials in on an emergency basis. And so this is — I
realize, I’ve got to work out a neat summary of
the things you’ve learned over the last couple days. So, one of the things we
had to do was get a permit from our USDA colleagues
because the viral islet that was being imported
contained fetal bovine serum. And so we were able to,
thanks to their good advice, get ahead of things and make
sure with the sending lab that fetal bovine serum that
had been used originated in the United States,
which still meant that we needed a permit,
but avoided us having to have the product quarantined
in Plum Island for foot and mouth disease or
other types of concerns. We also, of course, got
a permit from the CDC, due to the infectious
nature of the sample. And we thought we
were done, but wait. The dreaded green monkey. So we found out, at
sort of the last minute, that we also needed a fish
and wildlife service permit, as they explained, relevant
to the Cites Treaty. The growth medium that
the cell was grown in by the sender was
derived from green monkeys. The viro-cell line. And so we were able to work it
out in the end, and I raise this because it is a, to us anyway,
a somewhat humorous, and I hope, memorable example, but of
how complex this can be, particularly when you’re
somebody like us in ASPER who doesn’t do this
on a regular basis. Right? We’re sort of
wandering into this space, in an emergency time frame, and
other subject matter experts that had worked in other areas
weren’t necessarily aware of all of the permitting. So thank goodness we had
access to this group of experts that could help us through it. So our bottom line takeaway
was that we were able to successfully import Zika
samples on a emergent basis. You know, we had some
delays, that the you know, the permitting requirements
would have, I think, been almost impossible,
had we not had, again, this sort of organized group of
experts to help us through it. And that’s what worked
really, really well, is to have established points
of contact and to have people that helped us, who worked
to expedite these approvals where needed and it
was really essential. So, our lessons learned
that we are going to use to move forward is, of course,
obtain as much information about the materials that
you’re trying to move, consider what the sample
may have been exposed to or that may be grown in,
or may have been nutrients that may have been provided. Those are all important aspects. And then what the
samples going to be used for at the end and by whom. And so, our next steps
is that we will continue to work both domestically
with this import export group, and through our international
partnerships to develop mechanisms
to facilitate this type of sample sharing
based on these lessons. And so again, on that
sort of the two levels that the 30,000-foot level,
we’re going to have to deal with these access and
benefit sharing issues at the world health
assembly level, and we’ll move forward
on that as well. But also the potential
for delays that come with negotiating material
transfer agreements and the — of course, then the permitting
and import export issues. But thankfully when I think — when I sort of lay out all
of the challenges we have yet to encounter, the
permitting issues are really, now that I have been through one
round of this in a cohesive way with this group,
that’s the least — that’s the least of our worries
when it comes to this sort of wider coordination. That we can do, right? We’ve got all the right people
and we can do that part. And so the way we’re going to
do that is to work through this, the sample sharing group
that I explained to you, to formalize some of
these lessons learned and these procedures that we’ve
used through both Zika and MERS, as well as Ebola, so that
we have processes to be able to obtain and share samples for immediate public
health priorities. And then as a sort of
second level thing, once we have those samples from
wherever we’ve obtained them, if appropriate to be able to
share them around the world with our international
partners to be able to facilitate their own
public health preparedness and response capabilities. So I think that is it. I would like to thank
[inaudible] from our team for helping put these together. And I realize we do not have
our contact information here, but we can certainly provide that if people have some
follow up questions.>>Thank you very much. We have a short break. We will resume promptly
at 2:40pm, but we’d like to
remind you again to please send your questions
to [email protected] We have a group of experts
here assembled [inaudible]. So, see you at 2:40.

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