BIS Export Licensing for Biological Commodities and Technology

BIS Export Licensing for Biological Commodities and Technology


Our next speaker is Dr.
Wesley Johnson of the Department of Commerce Bureau of Industry
and Security, Office of Chemical and Biological Control Division. He represents his division in
forums on licensing issues. His topic is Bureau of Industry
and Security export licensing for biological commodities
and technology. Dr. Wesley.>>Thank you very much. Good afternoon everybody. This is a little bit different
from a lot of the other agencies and a lot of the other groups
that are involved here today. As you can see I work for the
Office of Nonproliferation and Treaty Compliance. So the foundation of
our regulations is more in this nonproliferation world
and treaty compliance more so than in public safety
or in public health. So I think that’s a little
bit different than most of the other agencies
involved here. So just as a quick overview
of US export controls, the Department of Commerce, we
deal mostly in dual-use items and what we call the
600-series military items. I won’t get into military items
because that’s not really a part of this forum, but the
dual-use items are things that have primarily
commercial or academic use, but also have potential use in
biological or chemical weapons, or nuclear weapons
in some cases. Other agencies involved in export controls are
the Department of State. They handle munitions. The NRC, which does triggerless
commodities for nuclear items. The Department of Energy, which
has export controls specifically for technology for nuclear
materials and their use. And then the Department
of the treasury who we work with closely. They do controls on
financial transactions and special sanctions
for certain countries. So as I said, the rationale for our controls are a
little bit different. We have internal considerations,
national security concerns, foreign policy initiatives
and economic concerns that guide our regulations. But the bulk of our
regulations are guided by external considerations and
these are international regimes of which we are a part
to control certain groups and categories of
commodities and technologies. So for example, the Wassenaar
Arrangement will control conventional arms. We have the Missile
Technology Control Regime and they’re responsible for
materials and technologies for missile development
and missile programs. The nuclear suppliers group,
which handles nuclear materials and technology internationally. And then the group that I work with closely is the Australia
group, and they handle things that have potential
use in chemical weapons and for biological weapons. So looking at our commerce
control, specifically as I said we deal with
the dual-use commodities and technologies. So we have exclusive
jurisdiction over the dual-use items. And again, predominantly
commercial or academic applications for
these items and technologies. But they also do have that
potential use in nuclear, biological or chemical weapons
development or programs. We operate under the export
administration regulations. This is the EAR, if you
refer to it as the ear, we know that you are not
used to dealing with the EAR. It’s a specific designation. And there’s two ways
we control items. There’s list-based controls, which is the commerce
control list. And this is based on the items
and the technologies themselves. The sensitivity of the items,
the potential risk of the items, any past history of the
items being used or sought for chemical or biological
weapons. And then there’s
catch-all controls. And the catch all controls,
that’s based on who it’s going to and what they
intend to do with it. So in that case something
that’s not specifically listed on our control list
like tables or chairs, if we know that it’s
going to an end user that is developing a
chemical weapons program, or developing a nuclear weapons
program, we have the catch-alls in place to prevent
that transaction, to prevent supporting any of
those development programs. The classic example of this
is we have denied export of baby wipes to a
nuclear end user, knowing that they were going to
be used in a nuclear program. So what is subject
to our regulations? It’s very broad in scope. Essentially everything in
the United States is subject to our regulations except
for a few exceptions. So commodities and technologies
that are exclusively under other agencies jurisdiction. So here are things that
the primary example is the department of state. They have exclusive jurisdiction
over munitions and arms, certain munitions and
arms under the ITAR. So those are not
under our regulations. Anything that’s publicly
available technology and software, information that’s
already published or is intended to be published, we don’t
have jurisdiction over. Anything that arises from
fundamental research, anything that’s educational
and information that’s included in patent applications. So it’s easier to talk about
things that are not subject to our regulations than it is to
list everything that is subject, because it is almost everything. And actually there is
another caveat to this. We do have jurisdiction
over some things that are outside
the United States if they have a certain
content of US origin technology or US origin products. But that doesn’t really apply
to the biological world here. So we look at our commerce
control list and the part that we’re going to be
focusing on today is chemical and biological weapons and
these controls are based on international regimes
and international treaties. So the Australia group is
primarily where our list of biological and
chemical agents comes from. We also adhere to the chemical
weapons convention scheduled chemicals and the
biological weapons convention. The other parts of the commerce
control list are missile technology and that is run through the missile
technology control regime. Nuclear materials, which is
the nuclear suppliers group primarily, and the Nuclear
Nonproliferation Treaty. Then conventional arms with
the Wassenaar Arrangement. So we talk about
licensing for BIS, we have a designation
called EAR 99. And that is anything that
is not specifically listed on our commerce control list. So very common things that
don’t have any high-risk use or potential use
in these weapons of mass destruction would
be classified as EAR 99. So things like tables, chairs, organisms that aren’t
on our control list. They would be classified
as EAR 99. So anything that’s
classified as EAR 99 can go to most destinations
without a license. Then we have some anti-terrorism
unilateral controls that are just USG controls. And then we have
license exceptions. So that top of the
pyramid, that large list of items does not
require license exports out of our country except to
very limited destinations. So the bulk of things
that are exported in this country do not
require a BIS license. Most things will be
either no license required because they are EAR 99. In a lot of cases we do have
license exceptions available. And recently we’ve
been able to get a lot of those license
exceptions to apply to a lot of medical equipment and a
lot of toxins and some exports for things that are useful
in disease prevention. To try and limit the license
burden where things are needed and try to eliminate
the time lag in having to get that license. So in this world, what might
require an export license? So we have biological agents
and genetic elements listed on our commerce control list. The export control
classification numbers for these are 1C351,
1C353 and 1C354. These are important sections
to know if you are handling any of these agents or toxins or the genetic elements
from these agents. And these are CB1 control. And what that means
is we control these to every destination
in the world. It doesn’t matter if you’re
sending them to Canada or you’re sending
them to Nigeria or somewhere in South America. You need to have an
authorization to make that export of those
items if they’re listed. As I said, we do have some
license exceptions available for some of the toxins
that are listed. And what that means is you can
ship without a license using that license exception
as your authorization. And I expect there may be
questions about that later and I’ll be happy
to talk about that. Vaccines, immunotoxins and
medical products, diagnostic and food testing kits. We have these on the
control list as well. These are classified as 1C991. So if you are exporting
vaccines or immunotoxins or these medical products
you should be aware where they are going and what
the designation is determines whether a license
is required or not. So this is an AT1 control. And what AT1 means, it’s
an antiterrorism control and it’s a unilateral control that the US government
has on these items. That only requires a
license if you’re sending it to North Korea, Syria,
Sudan, Cuba or Iran. So if you’re sending
it anywhere else, no license will be required
for those commodities. So again, a lot of people get
very concerned when they see that their vaccine
may require a license, but we’d like to comfort you
that only if you’re sending it to places we ordinarily don’t
like people doing business with would it require
that license. We also have biological
processing equipment. I know a lot of the folks in
this room and a lot of the folks that we’re talking to today
probably aren’t doing exports in equipment so much, but if
you are sending fermenters or filtration equipment or
spray driers or anything that can be used in production
of biological materials, it’s controlled under
our ECCN 2B352. And this is a CB2 control. What that means is it will
require a license to anywhere in the world except to our
Australia group member states. So that list of 42
countries that are part of the Australia group, it would
not require a license there, but it would anywhere
else in the world. Technology, this is a little
bit trickier to get a handle on. But we also control the
technology that’s associated with the development
or production of biological agents
or genetic elements. This is covered under
ECCN 1E001. Again, the CB1 controls. So if you are exchanging
the technology to produce or develop controlled organisms, it would require a license
anywhere in the world. Now the caveat here is if
you remember I said earlier that technology that is publicly
available, published or intended to be published is
not subject to EAR. In most cases the technology
for development and production of these agents is published. How you grow a bacterium is
well understood and well known in academia and published
literature. So we wouldn’t control
standard technology for grown and culture of these organisms. However, if you have some
proprietary process or methods that you’re using that is not
published and is not intended to be published, that’s when that technology would
become captured under the EAR and you would be required
to have a license to export that out of the country. We also control the
technology for the development and production and
use of the equipment. Again, that controls
the CB2 control. So we would only require a
license to non-AG member states. And the same thing
applies there. The bar for becoming controlled
technology is pretty high. When you send an item or a
commodity over for standard use, let’s say you send
a fermenter over or you’ve exported a
fermenter, the user manual that tells you what you
need to do to operate that equipment is considered
part of that equipment and would not require a
separate technology license. And in fact our use definition for technology is
a very high bar. It requires intimate
knowledge of refurbishing and reconditioning and
installing the items. So your typical day-to-day
operation of a fermenter or a centripetal separator would
not fall under that category. It would be specific. Deemed export is
another tricky one. If you have foreign nationals
working at a US facility in a laboratory, for example,
if they are going to have access to controlled technology, having them in your laboratory
will require a license for them to access that technology. This is sort of a tricky
subject for a lot of people. Again, because we
deal with technologies that often is published
and publically available, if that’s the only technology
that they’ll be dealing with, no license will be required. However, again, if you’re
working on technologies and methods that aren’t
intended to be published, that are proprietary, then
any foreign national working in your lab may require
a license just to be in your lab and working. We also do re-exports. These are commodities
and technologies that are already
outside the United States that were originally
here in the US and are then being re-exported. So for example if you have
shipped a toxin to Germany and they wish to share it with
some research partner of theirs in India, that would be a
re-export from Germany to India and would require a BIS license since that material originated
here in the United States. And again, we like to really hit
home on the license exceptions because we encourage people to
use them as much as possible, because it’s a lot simpler
and doesn’t require you to go through the process
of getting a license and it keeps things off my desk. So the commerce control list for
organisms and biological agents, it’s bigger than the
select agent list. Certainly we have all the
select agents on this list, but we also have some other
things that are on there because they have a history of
attempted use in bio warfare. Whether they worked or not, whether it was a good
plan is irrelevant. If they were sought for
a biological weapon, they make it onto the list. And they have to be things
that can cause serious economic or public health problems, and
they have to get on our list by Australia group
member consensus. So when a member state
decides that there’s an agent or something that needs to be
included that’s not on the list, this comes into our
annual meeting discussions. And we go round and round
about addition to the list. And it can only be
added to the list on consensus of the
entire group. So some examples of AG-controlled
nonselect agents would be like yellow fever virus, chlamydophila psittaci
and lyssa viruses. And there’s a couple toxins
too that are on there, cholera toxin and Aflatoxin. Again, not select agents,
but these are things that we would control
for export. Because they do have
history of potential use in biological weapons. So a lot of the questions that
we get are in regards to Ebola and high-path avian influenza. The Ebola virus, we require a
license for every Ebola virus, no matter the strain, no
matter where it comes from. If it’s in the United States
and is being exported out, then it is going to
require a license. You can use license
exception GOV if it’s going to a US government agency
overseas or if it’s going to a government of a
cooperating country. And in our regulations there’s a
supplement that provides a list of who those cooperating
countries are. And emergency licenses may
be requested as needed. We understand that if
there’s an outbreak, our standard 30-day turnaround of a license application may not
be adequate for the situation. So we do have that capability. If you submit as an
emergency license, we can process these
a lot more quickly. It still would be in
the order of 7-10 days, but certainly better than waiting a whole
month for your license. Then we look at the
avian influenza. We do not control
human influenza. It’s purely impractical
to suggest that anyone who has the flu can’t leave
the country without a license. So we only control
avian influenzas. And the bar to be highly
pathogenic, even influenza, is set pretty high under 1C351. So I encourage you, if you work
with flu, to look at the entry for 1C351 and read
that technical note on exactly what is required
to meet level of control for being on the list. So not all avian influenzas
are on the control list. Another sticking point for a
lot of people that we get a lot of questions is on
genetic elements and genetically modified
organisms. Our controls are specific
to elements or organisms that contain nucleic
acid sequences associated with pathogenicity of
controlled microorganisms. So the first thing I want to
clear up, the actual sequence of nucleic acids as published on
NCBI for example and Gen Bank. We don’t control that sequence. When we talk about a
sequence we’re talking about the actual physical
nucleic acids themselves. And they have to code
for controlled toxins or toxin subunits, or for
the organisms themselves. So one of the tricky points is
we use this phrase associated with pathogenicity. With bacteria we feel this
is pretty straightforward. There are certain
families of gene products that we know are involved
with pathogenicity. With viruses, it becomes a
little trickier and rather than name individual genetic
components from one virus to another, because then your
entry for that would be massive, the tack we’ve taken is that
we consider most sequences to be associated with pathogenic
avian flu viruses at this time. So we encourage anyone
who has questions about whether their plasmids or whether their genetic
elements would be controlled to contact BIS and get a
commodity classification or at least have one of our
biologists talk it over with you and if you can provide
documentation that that element is not
involved in pathogenicity, then we can work that through. But this control of genetic
elements only applies if the agent is on the
commerce control list. So we don’t control
genetically engineered corn. We don’t control genetically
engineered E. coli unless it’s the toxin gene itself
for the toxic types. One of the questions that’s come up a lot lately is these
Chimeric viruses that have sort of been in several publications
that have come out recently. So the examples that
we give here, if you have a vesicular
stomatitis virus that has the glycoprotein
substitute with an Ebola virus
glycoprotein, we would control this as a 1C351
genetically modified organism. And for this you would need
a license to send it anywhere in the world or at
least an authorization. It would still be available
for the GOV license exception to certain users, to
certain governments, but in general this is going
to require a BIS authorization. Another example is if we
have a controlled virus, which yellow fever virus
is controlled on our list, if the structural protein
components are substituted with the West Nile virus,
which is not controlled, we still have a controlled
genetically modified organism because it contains
genetic elements of a controlled organism. Another example is
if we have components of a controlled organism
that are being substituted or being added onto a
non-controlled organism. This again becomes a
controlled organism because it contains
those genetic elements that are considered
pathogenicity of the controlled organism. So in this case the
foot and mouth disease which is controlled, the
structural components are added onto the human immunovirus
5 which is not controlled. But that addition to that
genetic material makes this a modified organism
that is controlled. And then another common question
new get is genetic elements. Expression plasmids to
study specific components of viruses are very common
and they’re traded heavily in the academic world. And we try to limit
our controls to things that actually have
potential to be dangerous. So in order to limit the
licensing burden for example, when we deal with high-path
influenza, if the HA, hemogluten sequence, is part
of this expression plasmid, we will only control if it if contains the promotor
sequence as well. Because that’s the only time that this will actually
produce a functional and replicating HA gene product. So if it’s not the
absolute complete gene, then it’s not going
to be controlled. We don’t control truncated
or shortened gene sequences. It has to be the entire
open reading frame for us to control on our list. So I want to end this by
going through a few questions about the EAR and these are
questions that we get a lot. So for example, if an
agent is on the CCL and is on the select agent and
toxin exclusion list, is a license still
going to be required? Yes. If it is on our list,
our list does not adhere to what goes on with other
agencies’ jurisdictions and regulations. If it’s on our list, it is
subject to our regulations and a license is going to be
required for the export of this or any of its genetic
elements to any destination. What if we’re sending a
CCL list of toxins other than saxitoxin and ricin? So if you’re dealing with any
of these toxins, saxitoxin and ricin are special cases
because they are also controlled under the chemical
warfare convention. So these license exceptions
are not available for those. But for most of the
other toxins, if you are not sending more
than six shipments per year to the same end user and
you’re not sending more than 100 milligrams
per toxin per shipment, there are 36 countries where
you can use this strategic trade authorization licensing
exception to ship without a license. What if we’re sending
a biological agent that produces a CCL
listed toxin? So we control the organisms
and we control the toxins. However, in some cases
we control a toxin but not the organism. So the answer to this one,
unless the agent itself is on the CCL, no license is
required for the agent. And what that means is we
control staphylococcal toxins, but we don’t control
staphylococcus as an organism because then everyone would
have to have a license to take their skin
out of the country. So we try to be reasonable
with these things. Cluster [inaudible] is
another example the other way where we control
both the organism and the toxin that it produces. So if you’re sending the toxin
or the organism, you’re going to require a license
for that one. What if I’m sending the
equipment to another government? You can use this license
exception GOV for use in cooperating countries. That does not apply
to Africa and most of Asia and South America. So that excludes pretty
much everyone but Europe. But if the US government is
going to be using it itself in another country or if the
department of defense directs that export to themselves,
then that is eligible for this license
exception and you can ship that without a license. You just need to make sure you
have the paperwork indicating that it’s going out under
this license exception. And this is a question
we get an awful lot, do I need an export license if I have a foreign student
working with a CCL pathogen? Most cases, probably not,
unless you are dealing with non-public domain
production technologies or techniques, which
is very unusual. The only examples that
we really see of this are when private corporations are
using certain bio products as pharmaceuticals. They will have particular
processes in place that differentiate their
product as a medical item than the standard
published methods that generate the
toxin just in bulk. So in that case because their
methods are proprietary, that technology would
be controlled. And any foreign national working in that laboratory would
then require a license to do that work. So I’ll end with my
contact information. I know the awareness of
BIS licensing is limited. I was surprised to
learn about BIS when I first started
working for them. So I am always willing
to talk to people. I encourage you to call me
directly or email me directly if you have questions. For more general guidance,
our website is bis.doc.gov and there are tabs
there that will lead you into licensing specific
questions, regulation specific
questions, deemed exports. There’s a separate
category for that. And then we have our chemical and biological controls
division guidance section where if you’re dealing with
medical items or biologicals or toxins or if you’re
dealing with chemicals, you can find specific
guidance on that page. That will wrap it up. Thank you very much.

Danny Hutson

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