2014 Import Permit Program Webcast Part 2


Good afternoon and welcome back to the continuation
of the presentations. Dr. Deborah Dufficy will
talk about the import and interstate transport
of organisms and vectors of infectious diseases
of livestock and poultry. Dr. Dufficy?>>Thank you, Lourdes. Welcome back everyone. I work for the United States
Department of Agriculture, USDA, in the Animal and Plant Health
Inspection Servis, APHIS. I work for a program
called Veterinary Services and within Veterinary
Services I would in the National Import/Export
service in the Organisms and Vectors Permitting Unit. I’m here today to
discuss organisms and vectors permitting. I’ll give you a quick
overview of the hierarchy under which organisms and
vectors permitting falls and we will discuss our mission. I’ll discuss the authorities in
which we conduct our permitting, I’ll cover the application
process, the items that we regulate,
best practices for applicants and I’ll provide tools that
might be useful to applicants. The animal and plant
health inspection service of the United States
Department of Agriculture exists to protect the health and
value of American agricultural and natural resources. There are 6 programs
within APHIS, the programs are Animal Care, Biotechnology Regulatory
Services, International Services, Wildlife
Services, Plant Protection and Quarantine, and
Veterinary Services. You will hear today from the
APHIS Program’s Plant Protection and Quarantine and
Veterinary Services. I’ll present for Veterinary
Services, organisms and vectors, and Shirley Wager-Page will
present for plant protection and quarantine pest permitting. Veterinary Services’ mission
is to safeguard the health of animals, people,
and the environment. Veterinary Services has 4
pillars, permitting is performed in 2 of the pillars, National
Import Export Services and in the Science Technology
and Analysis Services pillar. Within National Import Export
Services there are 3 permitting groups, live animal permitting,
animal products permitting, and organisms and
vectors permitting. As a brief overview, live animal
permitting permits importation and international,
and interstate transit of live animals and germplasm. Germplasm includes semen,
embryos and hatching eggs. Animal products permitting
permits importation of material derived
from animals or exposed to animal source materials. Materials that require a
permit include animal tissues, blood cells, or cell lines of
livestock or poultry origin, RNA or DNA extracts, hormones,
enzymes, monoclonal antibodies for in-vivo use in
non-human species, and certain polyclonal
antibodies. Organisms and vectors
provides import permits and interstate transport permits
for organisms and vectors of livestock and
poultry diseases. The Center for Veterinary
Biologics, CVB, is housed in the
Science, Technology, and Analysis Services pillar. CVB has a permitting group that
permits imports of biologics to assure pure, safe, potent, and effective veterinary
biologics so that they are available
for diagnosis, prevention, and treatment of animals. Our authorities are
derived from the health, Animal Health Protection Act,
which authorizes the Secretary of Agriculture to make
and enforce regulations that are necessary to
prevent, detect, control, and eradicate diseases
and animal pests. Included in this regulatory
authority are animals and articles, which are in or affect interstate
and foreign commerce. The Virus Serum Toxin Act
authorizes the Secretary of Agriculture to regulate
quality of veterinary vaccines and biological products in order to ensure safe and
efficient supply. Included in this regulatory
authority is importation of affected agents. The code of the federal
regulations 9CFR parts 101 definitions 104, biological
products, 122, organisms and vectors, and 123, the
virus serum toxin act rules, are the codifications of the
above-administrative acts. In an effort to protect
agriculture and specifically livestock
and poultry organisms and vectors permitting
regulates the importation into the United States
and interstate transport of organisms and
vectors pathogenic to livestock and poultry. As I just mentioned, we regulate
organisms that cause disease in livestock and poultry. We also regulate vectors
that carry both foreign and domestic diseases. Vectors include insects,
infected or exposed animals
or animal products. We make sure that proper
biosafety precautions are in place to safely handle
the organisms or vectors for the particular use for
which they are intended and we keep a database so we can
trace organisms if necessary. One of our major duties
is to ensure biosafety. Inspections are 1 way of
ensuring this biosafety. The inspectors at the National
Import Export Services Centers around the country
provide inspections for materials requiring
biosafety 2 and 2 plus and animal biosafety level
2 and level 2 enhanced. The select agent inspectors and the service center
inspectors provide inspections for materials requiring
BSL3 handling. Inspections impact
processing time of applications because applications are held
until inspections are completed. Here is a brief overview
of the application process. An applicant submits
the application form, the VS form 16-3. The applicant can
decide to submit through the electronic
process ePermits or can submit by fax or email. For us in organisms and vectors
the entire process is conducted within ePermits. Submission through
ePermits greatly reduces the processing time. After receipt the
application goes to data entry. Here the application is
hand-entered into our system, if it doesn’t come
in through ePermits, the application is reviewed
and clarified if needed, fees are paid and
jurisdiction is evaluated. Next the application is
assessed for completeness and there may be some
questions and answers that go back and forth. A draft permit is constructed
based on which organisms and vectors are requested, where
they’re coming from, whether or not they were exposed to risky animal materials
during processing or shipping, their intended use and what
type of facilities are needed to safely handle the organisms. If inspection is required for
the materials to be transported or imported an inspection
is initiated at this stage of processing. As mentioned earlier, inspection
must be complete before the draft moves forward
in the process. Once questions are resolved
the draft permit comes to the veterinary
medical officers. We review the application
and documentation and look at such things as
the biosecurity of the applicant’s facilities,
intended use of the material, country of origin of the
materials, disposal method, and we verify that organisms and vectors permitting
has jurisdiction over these materials. After approval the permit is
processed and mailed, faxed, and/or emailed to the applicant. Some best practices in the process include
applying through ePermits. Electronic submission
significantly shortens the time needed to process
the application and eliminates data
entry errors. It is also helpful to review the
no permit required guidelines. These guidelines spell out which
materials do not need a permit. If no permit is required there
is usually some documentation like a statement
or certifications that should be included
with the shipment. It’s always a good practice to
include the printed guidelines with the shipping documents. The permit is either an import
permit or a transport permit. An import permit is for
movement of materials into the U.S. to the applicant. Transport permits are
for transportation across state lines
to the applicant. The restrictions are more
stringent on import permits. The permit is for movement,
either interstate movement or importation and
receipt of the organism. We’ve recently noticed that some
applicants are renewing permits so that they can
possess the organism or to change the
use of the permit. For example, changing
in-vivo use from 1 livestock
animal to another. So long as the restrictions
on the permit are adhered to, renewals of this
nature are unnecessary. To reiterate, a permit
is only required to receive regulated
material via import or interstate transport. Import permits require more
information from the applicant than transport permits. The sooner we have complete
information the faster we can process. A few examples of the
information we need for import permits are:
We need a full description of the organism that means
genus and species for bacteria and the full name of the virus. For example, an applicant could
request an influenza virus described as influenza
A, Puerto Rico, 834 H1N1. In the case of bacteria
the applicant must verify that the organism
was sub-cultured at least 4 times
prior to import. We need to know the country
of origin to determine if there are diseases
endemic to that country that we might be concerned
about in the imported material. We need to know if there are any
animal origin nutrients or media that came in contact with the
organism and we want to know if there was exposure
to livestock or poultry. The reason we want to know these
things is the National Import Export Services classifies
countries according to their disease status. As an example, let’s say
that country A is known to be infected with
virulent Newcastle disease, a poultry disease considered a
select agent in the U.S. Viruses that were grown in eggs or
egg products originating from country A would
not be allowed into the United States unless
the material was safety treated or safety tested at our Foreign
Animal Disease Diagnostic Lab. Another example, a common
nutrient, fetal bovine serum, is acceptable if it originated
in the U.S., Canada, Australia, or New Zealand because these
countries are considered free of foot and mouth disease and
other diseases of interest. The disease status of the
exporting countries can be found on our website in the
Animal Products Manual, appendix C. The method of
inactivation should be provided if the material or
components are high risk or if the material comes from a country endemic
for select agents. Here are the directions
to the web information. You’d start at usda.aphis.gov
and drill down into imports, imports and exports then
animal and animal products. The list of foreign
country disease status and the no permit required
guidelines are here. If you click on organisms and
vectors, instead of animals and animal products, you’ll
find contact information and various permit forms. We are currently
revising our site content for organisms and vectors. This is in an effort to improve and streamline our
permitting process. We are always happy to answer
questions before, during, or after the application. Contact information is listed
on this slide and I’ll be happy to take questions at the
general question session. Thank you.>>Thank you Dr. Dufficy. Now we have another
USDA guest speaker, Dr. Shirley Wager-Page will
discuss best permitting policy in protecting American
agriculture and environment. Dr. Page?>>Thank you Dr. Mueller
and I want to thank the CDC for inviting us to participate
in this, this important session. My name is Shirley
Wager-Page, I am the chief of the Pest Permitting
Branch for Plant Protection and Quarantine, PPQ, USDA
APHIS in Riverdale, Maryland. And first I want to talk a
little bit about our authority and it’s under the authority
of The Plant Protection Act, the Secretary of Agriculture may
prohibit or restrict movement into or through the
United States or interstate commerce including
territories and possessions of plant pests, plants,
and plant products and associated articles. This authority is to
prevent the introduction into or dissemination within the
United States of a plant pest or noxious weed in order
to protect plant health. This authority also includes under the plant pests
select agents. PPQ issues permits
for the movement of commodities including
fruit, vegetables, plants, wood and wood products and
these commodities, excuse me, are intended to be
free of plant pests, therefore they will not
be discussed further in this presentation. The Pest Permitting
Branch issues permits and others documents authorizing
the movement of plant pests. Permits include requirements that provide the appropriate
level of safeguarding to prevent the dissemination
of these pests into or through the United States. Impediments to foreign commerce and travel are minimized
whenever possible that is because we are issuing permits
for a wide-range of plant pests and federal noxious weeds that
have varying levels of risk. The implementing regulations
are found in part 7, Code of Federal Regulations,
7CFR, specifically 7CFR 330 and 360, which provide
the specific authority to grant plant pest permits. A part 330 permit is
required for the importation or interstate movement
and subsequent movement of plant pests, biological
control organisms, and associated articles. For instance, soil would be
considered an associated article or some of the plant pests are
imported into the United States or move interstate with host
materials that are required for their life cycle
and sometimes these, these host materials are
also regulated articles. Similarly, a part 360 permit
is required for importation, movement interstate, or
release into the environment of federal noxious weeds. Customs and Border Patrol
enforce these regulations at U.S. ports and
border crossings. Well who needs a
plant pest permit? Any U.S. resident who wants
to move live plant pests, biocontrol agents, parasitic
plants, federal noxious weeds or soil into or through the
United States requires a permit. PBQ uses the ePermits database
to process permit applications, which you have just heard
that process described. That’s the same 1 that is
used by Veterinary Services. The permit holder is
the responsible party and not the exporter or shipper and permits are
non-transferrable. We have permit types
according to movement. Permits are issued
for, as we said before, interstate movement,
importation, environment release, and environmental release
includes field studies, and continued curation
of the following: invertebrate organisms
and arthropods, plant pathogenic microbes,
which are fungi, viruses, and bacteria, nematodes,
mollusks, federal noxious weeds, soil, and biocontrol organisms. Some of these organisms
are also regulated by other federal agencies
and we often consult with those agencies when
developing permit requirements. Plant pests can be
designated either direct or indirect plant pests. An example of an indirect
plant pest is a vector. We also may be an impact
on a beneficial organism such as a pollinator would be an
indirect effect on plant health. Continued curation
extends the retention of a regulated article. The permit types, according to
intended use, are as follows. For research and lab, growth
chambers and greenhouse, field research, which is
typically restricted to 10 acres or less, organism isolation and identification and/or
taxonomic studies from soil and other related
materials, diagnostic samples for identification
of plant pests, organisms for taxonomic studies, evaluation of microbial bio
pesticides and biocontrol, further biocontrol properties. Some of these are permits where
the plant pest identification and taxonomy are unknown. Basically, they’re diagnostic
or the isolation identification and taxonomic studies. We have a requirement that
after the studies are completed to identify the plant pest
that another permit is sought for its use after
it’s identified. There are additional intended
uses for regulated organisms and associated articles,
religious and cultural purposes, educational use, commercial
sale and distribution, display, human and animal consumption. In this category of
intended use these tend to be lower risk organisms and often they are being
released into the environment. Intended use is, is
a contributing factor to the potential plant
health risks associated with regulated articles
and we regulate them on the level of risk presented. The following are the
regulatory decisions that we make following the
receipt of an application. They could result in the
issuance of a permit, denial of the application
for a permit, withdrawal or voiding the application,
which is done by the applicant generally
after some discussion with us, cancellation or suspension of
a permit that’s post issuance if something is found that safeguarding
cannot be maintained, or a letter of no
jurisdiction or a letter of no permit required. And I will go into these
in a little more depth. The regulatory decision
to issue a permit happens after evaluations and reviews, permit applications
are completed and it will specify the required
safeguarding for the purpose of preventing the
dissemination of plant pests into the United States. In the case of say, for
instance, a select agent some of this evaluation has been
done prior to the application and there are lists;
however, for the majority of plant pests the evaluation is after we’ve received
the application. Some of the pests are well
known, are in our database, and others are new to
the permitting process and require further evaluation. Permit conditions provide the
required safeguarding measures to ensure safe movement,
containment, use, and disposal of regulated articles. This includes the type of
movement that can be included such as hand carry, whether
we require bonded carriers, also the level of containment,
packaging during movement, and the treatments
or types of disposal so that the pest is
devitalized prior to disposal or during the disposal process. We also deny permits
and an application for a permit will be denied if needed safeguards
cannot be arranged to prevent dissemination
of plant pests into or through the United States. We also have 2 other
documents that we use. The first is a letter of no
jurisdiction, which is issued if the article is not a plant
pest or biocontrol organism. This letter helps to facilitate
the movement of, of organisms through the port of entry
because it indicates that the organism has been
evaluated and we have found that it is not a
plant pest; however, in that letter we direct the
applicant to other agencies where we believe that the
organism may be regulated. A letter of no permit
required may be received for proposed movement of certain
organisms recognized as common and widespread within the United
States, generally organisms that are cosmopolitan. R30 is very broad and it
includes all plant pests. It is not, does not exclude
those that may be low risk. Interstate movement, we do have
policy, the plant protection and quarantine does
not have the authority to regulate interstate, that’s
within the state movement of organisms, unless a federal
permit was previously, if a, unless a federal permit
was previously issued for the organisms and that says that the organism
entered the state from without either another
state or an importation. The original permit
must be amended or a new permit issued
for this movement. The new destination and permittee information
will be included on the permit as well as the origin,
intended use, and movement type
previously authorized. And this is a way of
tracking the permit from the entry through
its disposal. About 50% of our permits
require containment. Containment facilities
are required for pests that are assessed by the
pest-permitting branch to be medium to high risk to
agriculture or the environment. These plant pests need special
containment features and/or handling procedures
that will ensure that they are not disseminated
into the environment. We have about 4 different
levels. We do not use the BLS criteria
for plant pests; however, the highest level is equivalent. Containment, there are many
considerations, excuse me, containment is typically
required for organisms of foreign origin,
dependent upon the plant, level of pest risk
and the consequences of unintended release, therefore
are there host materials within the country? It says, presence of host,
climatic and ecosystem factors in North American is
primarily a temperate country. There is not as much risk if
we have tropical organisms but that is evaluated. Mobility of the plant pests,
spread, airborne, waterborne, and vectors, likelihood of
introduction, establishment, and spread if released
into the environment and that would be an unintended
release so we would look at the likelihood of its ability
to escape and the availability of treatments to
devitalize the organisms and that would also be are there
pesticides and so on available if there should be a breech? Compliance and enforcement,
Customs and Border Protection and PPQ field operations
staff perform inspections and identifications. They are responsible for
enforcement actions pertaining to noncompliance that are taken at the port and border
crossings. PPQ personnel work in 17 plant
inspection stations located throughout the United States. PPQ field operations and headquarter staff
are responsible for conducting periodic and unannounced compliance
inspections of containment facilities. These are, generally our
permits are 3-year duration, inspections are annually
and, or could be more often. Violations of 7CFR330 in
field locations are referred to APHIS’s Investigation
and Enforcement Services or the Struggling Interdiction
and Trade Compliance Staff. Thank you. We also have a customer
service number, which is listed, both a direct number
and a toll free number and we also have an inbox to
prefer to send email to us and we will get back
to you in response to your questions or concerns. And listed also at the end of
this presentation are a number of URLs for additional
information on our webpage. And I will be happy to take
questions during the question and answer period. Thank you.>>Thank you Dr. Wager-Page. That was very informative. Before I introduce
the next speaker I’d like to remind the
registered participants to please submit your
questions to [email protected] That’s [email protected] Still another new speaker this
year is Dr. Romalito Lapitan from the U.S. Customs
and Border Protection. He will present border
management and control of imported materials. Dr. Lapitan?>>Thank you Dr.
Mueller and thank you for inviting me to
this presentation. It’s a pleasure to
represent CBP in this forum. I belong to the agriculture
programs and trade liason with the U.S. Customs
and Border Protection and just a little clarification,
we talk of Customs and Border Protection,
we are the folks that man the ports of entry. There is also, we are the
ones that wear black uniforms. There is the Border Patrol
that wears the green uniform and they’re the ones that
manage the, the borders that’s in between ports of entry. Today I’m going to
be talking about, I’m going to give you
insights on the regulatory and enforcement roles
of CBP but I’m going to be specifically
focusing on the missions and the agriculture mission of the agriculture programs in
the Trade Liason Office. I ‘m going to be also talking
about partners, our partnership and alliances with
other agencies and some of the regulatory requirements
from CBP perspectives on the importations of
infectious biological agents and infectious substances
and vectors. So I’m going to be
limiting my presentation to, to that, to that window. I mean, because I can always
still talk about the plants and animals but for this, for
this presentation I’m going to limit my presentation
to the biological agents. And then I’m going to
give you examples of some of the enforcement actions
that we have done in the past and recommend at the
very end, some of the, and this is what we do for,
to our trade stakeholders to recommend what
are those things that can possibly facilitate
processing of their entries through ports of entry. APTL within Customs and Border
Protection provides leadership, the expertise, and innovation in
protecting American agriculture and natural resources. We have 4 divisions under APTL, the agriculture oversight
protection, operation ensures that there is consistent
implementation of inspection procedures
at the ports of entry. The Ag Policy and
Planning provides guidance to our agricultures specialists, the cadre of agriculture
specialists we have manning the border on pest exclusion and the
ag safeguarding ensures that, ensures compliance
of agricultural trade in a cargo environment. And we have another division
called the Ag Bioterror Countermeasures, which
I presently lead, and we develop programs to
prevent deliberate entry of bio threats and
other potential tools of ag in bioterrorism. So from this you can deduce
that APTL covers both compliance and security, which is
security being part of Customs and Border Protection. APTL manages a cadre of
agriculture specialists that are manning our ports
of entry across the nation. We operate under statutory
authority of 7 and 9, title 7, title 9 under the
Plant Protection and Animal Protection
Act, respectively. So CBP oversees all
imports and agricultures, APTL oversees all
agriculture imports. And we support other
federal agencies as well as state agencies and assist
them in the enforcement of their own import regulations. In so doing we actively network with the intelligence community
to, to also perform that role as well as we trade to make sure
that they are in line with us, in tune with us, in getting through legitimate
trade process. One of the agencies that
we support, the CDC, CDC provide us guidance for
the importation of materials or animals
such as dogs and materials such as bust meat and
NHPs or non-human primates. They also directly
communicate with the Office of Field Operations
within CBP and in the, at the DHS level
they issue alerts, alerts on disease outbreaks
to Office of Health, Office of Health Affairs,
which is also part of the whole department
of Homeland Security. We have about 328
ports of entry. About 15 of them are in the pre-clearance stations
outside of the United States. We have a cadre of 2400
agriculture specialists scattered all over the nation
at different ports of entry and they’re staffing
about 180 of them. No worries about that because
APTL develops training modules to actively train officers that
are manning those ports of entry without agriculture specialists
and agriculture procedures. If any, if there’s any
discrepancies found that’s related to agriculture
they have to refer that to agriculture
specialists for adjudications. We have talked about this and apparently this doesn’t
apply any more as far as restrictions on
where select agents can, can go through so apparently now
select agents can go through any of the ports of entry. All biological imports such
as select agents, toxins, etiologic agents, cell and
tissue culture and so on and so forth are required
to file a formal entry. You can do this yourself,
being the importer of record, and/or you can do
this through brokers. Brokers can easily
facilitate this. But 1 of the requirements that CBP has are
advanced notification and this is not just
CBP requirements but this is also Bioterrorism
Act requirement, or called BTA. For instance the entry should
be filed in air cargo no less than 4 hours prior to arrival. In land, border, and
rail no less than 2 hours and sea no less than 24 hours. Now CBP also developed programs,
we call Trusted Trade Program like CTPAT, which stands for Customs Trade
Partnership Against Terrorism. What that does, what
that program is, it provides opportunity for like
importers, brokers, and so on and so forth the trade
zone, I mean trade operators to actually enroll in
this particular program and have shipments or
entries pre-cleared so that when they get to ports of entry
processing is facilitated. And if you notice that
when they’re involved in the CTPAT it only requires
30 minutes notification. One of the reasons why we
require advance notification is because we do advanced
screening. Understand that we only have
so many officers as well as agriculture specialists
in the fields and we, we get millions of
entries per day. So advanced screening is a way by which we can adjudicate
shipments, that way when they
get through the ports of entry then release
is facilitated it and we can only focus on
those high risk shipments. Upon arrival all agriculture
imports are actively referred for agriculture inspection. When we get, for instance,
biological packages, when we get biological cargo,
we don’t physically open them but we do document review and document review
pretty much is looking at all the documentation
that should associate or should be accompanying
the shipments and this includes form 2,
letter of authorization, letter of no jurisdiction,
permits and there’s some APHIS
requirements like some letter of declaration indicating,
for instance, like if you’re importing cell
or tissue culture for human, in vitro or in-vivo research
then they shouldn’t come from a facility that’s
processing say chickens or poultry that may have
exotic or Newcastle disease. If everything is okay and
compliant they’re release, they’re conditionally released
into the United States. Conditionally because we have,
CBP reserves 30 day, I mean, 30 days to recall
that shipment if later on we found some
derogatory information about, associated with that
shipment; however, if there’s some discrepancy what
we do is we make arrangements with the broker or the
importer of record of, and, refer the shipments
to either CDC or VS, depending in whose jurisdiction
it is for adjudication. Now do biological entries get
into a passenger environment like airports and seaports? Yes they do. In fact, a lot of the
enforcement actions that we have are actually
in a passenger environment. Like in cargo, CBP
have developed programs for trusted travelers. In the case of air, air travel, we have developed the global
entry and we also have the, the automated passenger control,
which is available for U.S. seas as well as Canadians
and those citizens of visa-waiver countries. What that does is they
actually go into a separate lane and they have a kiosk where
they run their passport and the machine runs
their biometrics and the, the machine then spit out
a receipt that they hand over to the officer
at the egress in which there are
times that they get into some random questioning
but that’s all that happens and then they, they
exit the premise. Those regular travelers like
foreign nationals, for instance, go through the primary lanes
for admissibility checks as well as passenger screening,
asking them for declarations if they’re bringing
any fruits, vegetables or any biological products. If they’re not bringing in
any quarantine materials or prohibited products then
they’re, they’re good to go. But 1 of the thing that we have
as a second layer of checks, we have canine rovers around
the, around the airport or around the vicinity
to actually make sure if there’s any undeclared
items in the baggage that those little
guys can detect them. That’s a second layer of checks. In the land border we have
also Trusted Traveler Program. In the Canadian border
we have the Nexus and southern border
we have the Sentry. It’s essentially the same
theme as the global entry where they go on separate
lanes but at the same time in the land border they do go
through basically the checks too because we do get a lot of
foreign nationals coming through the land border. If there are QMIs or
quarantine materials or biological products either
found or declared then they go into agriculture inspection. They go into intensive
questioning, more intensive questioning
and all their luggages go through x-ray or
non-intrusive inspection. If there’s any QMI
they’re seized. If there’s any biological
import then we go through the same
requirement as that in cargo, we look for permits and other
materials or other documents that should accompany
the, the shipments. If, and then we refer them to
CDC or VS, Veterinary Services, or the local veterinary medical
officers for adjudication. If they’re okay then
they’re released and if they’re not then we,
again, we transfer custody for adjudication by USDA or CDC. Now I mentioned about something, materials that should
be declared because if those
materials, if, for instance, if there’s undeclared
quarantine materials that was detected
by K-9 then that may result in some CBP action, which
is usually a penalty, prior to release. International garbage is 1
of the critical pathway for and potential entry pathway
for like pathogenic pests and diseases and is 1 of those
things that we highly regulate. And in collaboration
with USDA we, we develop compliance agreements
with carriers, with haulers and with incinerators
to make sure that, and also we develop training
and materials, training programs to make sure, and
guidance, to make sure that those international
garbage are properly disposed. If we found some high profile
interception like, for instance, an actionable pest or a
first-time interception pest, which is new to science
or a select agent coming through a passenger environment
then it generates what we call a significant agriculture
incident report. This is some kind of alert
that’s generated and circulated within CBP to make sure that
everyone is notified about it. Because 1 of the thing that we
have found out is port hopping, and that’s 1 of those things
that we’re trying to make sure that we have a good handle of. It also generates
what we call an AEA, which is an agriculture
enforcement alert, which is a watered-down
version of the SAR and we distribute,
we disseminate these to partner federal agencies as
well as state, state agencies. We generate this twice a week. Enforcements action, this
is 1 of those things that, that we do that, this is
an example of 1 of them, like a traveler coming from Peru on a bus via Mexico,
entering Laredo. He declared that he’s got
some pharmaceuticals in there which happen to be
vaccines,Bacillus anthracis, all those virulent ones although
these are probably the weak viruses because they’re
vaccines, but they don’t have any permit. This would generate
that SAR. One of the, 1 of the unique
thing about this traveler was that with that declaration
we were forced to actively inspect the
luggage and we found out a lot of undeclared QMIs. This generated penalty. One of those things
that are close and dear to CDC are bushmeat. We get that a lot through ports
of entry like Washington, JFK, and Atlanta from countries,
Western African countries as well as Central
African countries. We, so we seize them and refer
them to either Fish and Wildlife and transfer custody to
Fish and Wildlife and CDC. In conclusion, just to summarize
and reiterate, the role of CBP, we oversees all imports and we assist all other federal
agencies and I think there’s about 47 of them, in enforcing
their import regulation. But it is the, the other
agencies like CDC, for instance, that has statutory and
regulatory responsibilities for protecting humans, in the
case of FDA the food system, in the case of Fish and
Wildlife, endangered species. And 1 of those things that
we, we put together to take, as a take home message to
the trade stakeholders is that be familiar with the
guidance that’s put together by the regulatory agencies because they’re the
same guidance we enforce at the port of entry. Like if they need
all the documents that should accompany
the shipment, make sure that they’re
all in there. If, if it requires to be carried
through the air environment or cargo environment then it
has to go through that and, you know, the kind of carrier
that it should go through. And just be aware
that in the process, if there’s any discrepancies
found then it’s going to cause a lot of delays. The notification
requirements, just make sure that you meet the notification
requirements per BTA and Customs’ requirements
because those are the ones that should be, there’s
no movement without satisfying
those requirements. And the earlier presentation
actually had shown that you have to input the port of entry
where it’s going to go to. If there’s a discrepancy on
that, say if it’s going to go to say Minneapolis
and it happens to land in Arizona there is a
problem, there is an issue and that’s going to cause delay. And again, we kind of recommend
to subscribe and enroll in our program because
that’s really, that’s, that would benefit a lot
and I’m sure a lot of you as travelers have gained from
being or from having enrolled in the global entry,
especially if you’re going through a new one that
should help you a lot. And with that I say thank
you for having me here.>>Thank you Dr. Lapidan,
that was informative. Again, before I introduce
the last speaker for today, reminder to our registered
participants, our lines are still
open for questions. Please send your questions
to [email protected] Again, that is
[email protected] No spaces. Although the system may not
be perfect, the importation of biological select
agents and toxins over the past decade has
been extremely safe and out of nearly 200 biological
select agents and toxin imports there has
not been a single incident of theft, loss, or release. Safe and secure importation of biological select agents is
a complex and important process. As society continues to
evolve we should expect to see increasing
importation activity of biological select
agents and toxins and other hazardous substances
that is why ongoing intra- governmental activity
such as development of the ITDS will be critical
in improving the system. Today’s webcast itself
is a great example of this intra-governmental
collaborative activity. We will continue to work
with partners within and outside the government to
improve the safety, security, efficiency of select
agent transfers and other critical imports. Having said that, our last
speaker for today, Bill Stephens of the Department
of Transportation. He will discuss DOT safety
regulations and requirements for transporting
infectious substances. Bill?>>Thank you Dr. Mueller. Thank you Von McClee
also and the CDC folks, for inviting us to
be a part of this. DOT PHMSA, Pipeline and Hazardous Material
Safety Administration, we do a lot of outreach
throughout the country and this is part of it so
that we can get out there and help you gather
the information for transporting
infectious substances or any other hazardous materials
out there safely for the public. And speaking of that I,
myself, Bill Stephens, I am the national team lead for the Select Agent
Program within the DOT. I have 5 regions total and
there’s 4 other investigators like myself who have
been trained to do specific select agent
inspections throughout the country. I have trained them
personally and we are out there to see the facilities that
do these shipping items. Want to make sure for safe
transportation, obviously. This particular guidebook that
we put out is free of charge and you can get it
off of our website. You can order hundreds if you
like and distribute it out. We want you to have the
information so this is where your tax dollars
are going. But if you follow this little
pamphlet guide that we have out here you don’t
need me up here, is basically what it amounts to. Everything I’m going to be telling you today is
coming out of that pamphlet. Unfortunately, the CDC has
only allowed me to talk for about 20 minutes
today, okay? In doing so we’re going
to have to cut some of my other program short
because I normally talk about cat A materials,
I talk about cat B, regulated medical waste and
some other issues, particularly about how we conduct
inspections. You’re getting the
short version today. We’ve got objectives
just like everyone else. We are going to find
an overview here of the regulatory requirements
for your 6.2 materials. We’re going to talk about your
package selections, your marking of these packages and labeling, your shipping paper
requirements, emergency response information,
very important and, of course, transportation security plan
and training requirements. So we’re going to
go through these because this transportation
security plan is much different than the CDC or the
APHIS security plan. We do regulate this 49CFR
for governing the packaging and safe transportation out
here in the public community. We want to make every
shipment safe. There are something like a
million and a half shipments of hazardous materials
every year. That’s an awful lot to govern
and to make safe out there on the road but it does come out of this little
pamphlet here, the CFR49. So if you’re not familiar with
that 1, you’re more familiar with the 7 and 9
let’s add this 1. Category A, infectious
substance, that’s what we’re going to be
speaking of today particularly. Of course, it is the 2814
and 2900 class 6.2 materials. Packaging requirements,
this is in your 49CFR. If you take nothing
away today from my part of the presentation here, take these references
in our regulation. The general packaging rules,
whether it’s a spec pack or a non-spec, if you’re
shipping hazardous materials know that section because
they’re general in nature. The requirements for all haz
mat regardless is the next 1. Changes regarding infectious
substances and mixed contents and then you have
exceptions under 173, 134, which will let you
out of some things but not necessarily select
agent stuff, obviously. The category A select
agent material, it could be a category
A infectious substance and not be a select agent but a select agent is an
infectious substance affecting humans, 196, 197, and 199,
which we are not going to be talking about, and then
the tests and requirements for these particular
packages that you need for select agent shipping. The category A packaging,
you’ve all seen this. This is on a little
pamphlet also. It is basically what we
want to call a triple pack. This triple pack is made up of your infectious substance
being inside of a vial. You’ll have some
absorbant material in there if that is a liquid, of course. If that vial were to break we
want it absorbed and be safe. We want your packaging material,
bubble wrap or something, around that vial or
2 vials or 3 vials, possible with bubble wrap,
to keep it from shifting around inside the inner package,
you’re secondary package, which must be watertight, okay? The secondary packaging, whether
it’s going by air or not, must meet air transportation
requirements for a pressure differential
package. Your plastic bag or your
can must be pressure tested and certified for a
different altitude, okay, 95 KPA pressure vapor,
pressure difference. Obviously, between the primary
and secondary packaging, once we close it and put the
secondary in the outer package, we’re going to put our
list of contents in there. That’s normally where
your form 2 goes and any other information you
want the receiver to have, okay? And then your package, of
course, is labeled appropriately with your infectious substance
label, which changes October 1st of this year, about 3 weeks ago. Make sure you are using
the appropriate ones because we will write
that violation up because it has been there
for a while and coming forth. Now it’s mandatory. It is a UN specification package and this particular 1 it
is marked UN4G class 6.2. This particular package is
only for infectious substances. It has been put through
rigorous testing, back on the preceding
slide of 178.609, to where there was a
30-foot drop test performed on this package after it was
frozen or a 30-foot drop test after it was watered down for
an hour to simulate 2 inches of rain fall got on it. We’re going to drop
it from 30 feet. We’re going to drop a 15-pound
rod onto the package from 4 feet and see if we can bust
that package and get to the inside there
where the vial is. There are rigorous standards
that must be passed in order to get this classification,
okay? Very rigorous packaging. That’s why it is a
safe package, okay? A very well known carrier
who’s wanting to get into the business had the
DOT there, we were there from the southern region
to represent and explain to them the safety
elements of this package and why their people should not
be afraid to handle it, okay? Your marking on the
package, real quick like, this is just certification that it did undergo the
testing requirements of 609 with a 30-foot drop test. We get a 4GU; 4G tells
me it’s a fiberboard box. The U tells me that
it was tested with a very fragile inner
package inside there, i.e. glass. Did it pass all the
required tests and didn’t break the glass? We can submit now
and put a U there, which means you can put any
kind of inner package in there that you want, a plastic
bottle, a metal can, any kind of inner package to hold your product
will go in that box. If it does not have a U
you will have to do it with the tested package
it came with and it may be a plastic
bottle with a wide lid on it, it comes in a kit if you will, don’t substitute
the inner packaging. That will get you
in trouble quickly. Class 6.2, obviously,
again very specific to infectious substances,
cat A material. We will have on there the
year it was manufactured. Combination package must be
manufactured within 2 years of a particular test date, okay? So that test date is only good
for 2 years on the test report and during that manufacturing
process he can make a whole bunch of them, okay, and not
use them until 5 years later because he made so many of them. That package is still
good, okay? It is still good because it
was tested and was still made that same way it was
originally done 5 years ago. U.S.A. and then the
test report number. The plus tells me it’s a third
party tester, someone out there who is in the testing
program business, he has put these packages
through all the tests, plus AA identifies who he is. In this particular case, a
company up in Minneapolis. And then his test report number. I can call up the
company and say send me that test report number and
I’ll have it on my phone in just a few minutes so
that I can check to see if you are using the
right inner packaging for the material,
for the package. Okay? We can find out thus
whether you are using a certified tested package. So a class A package
here is very important. Do not substitute
the inner packaging. Testing of packages. We talked a moment ago,
we’re going to wet that box for an hour to represent 2
inches of rain on that thing and then we’re going to
subject it to a drop test. We’re going to freeze
it down to zero degrees and then subject it. We’re going to drop
that 15-pound rod on it. We’re going to put dry ice in
there if it does call for it and thus certifies it and
then, of course, the variations to get the U. We can use
a smaller inner package. Instead of a half-gallon
bottle maybe we can go to a quart bottle but it’s got
to be of the same makings of it, the same cylinder size, the
same wide openings of it. It just can’t be something
little now just because you want to throw something in there. It’s got to be of
similar design. Watch yourself if you
change the inner packaging. You can put less
number in there. Obviously, it may
have been tested with 10 vials in there, okay? You can put less in
there, it’s not a problem. Marking requirements, on
the package we’re going to put the proper
shipping name UN2814, which will be infectious
substances affecting humans UN2814 and no technical name,
no technical name is going to go on the package, okay? Why? We don’t want Joe Johnny
out there handling this stuff to know necessarily
what’s inside of it, okay? Continental US shipments and all
leave this name off the package. CDC, this works with them,
this is our exception but at last CDC now have their
policy for lost in the crowd. We want that cat A package to
look like this cat A package that has a select agent, okay? We don’t want anybody
to know the difference. Who needs to know
the difference? The shipper and the
receiver, okay? The shipper affixes
the information, identification infectious
substance label, the orientation arrows if you
need it and your dry ice label if you need that 1 also. So that’s your package
marking requirements. There’s your label. It changes, first and basically
what it does is take off the notify CDC if there’s
any package damage. Don’t call them on regular
infectious substances, okay? They don’t want to hear it. Your shipping papers, you’ve
got to have shipping papers. You’ve got the identification
number first, UN2814. Proper shipping name, again, here’s the technical
name problem again. Don’t put the technical
name on the shipping paper. Where does the shipping
paper go? On top of the package, okay? We don’t put it on the box
why are we going to put it on a piece of paper that
goes on top of the box? Okay? Let’s don’t tell them,
let’s keep it lost in the crowd. So we can and must put
something in there so we have, in the regulations, suspected
category A infectious substance to go in your parenthesis
for your technical name. So something must be in there
and our regulations tell you to use this and we will
help the CDC out, okay? We’ve got a hazard class. There’s no packing group. We want to know the type of
package and your unit quantity. It’s a box, okay? It’s a cylinder,
whatever it happens to be. Your shipper certification and your emergency
response telephone number. This is about what
it would look like. And you’re, let’s
back up 1 here. And very important about the
emergency response telephone number, if you put 1 on there,
if you put your cellphone on there you live
with that thing until the package has arrived and I mean literally
live with it. That means go to
the shower with it. That means set it
beside your bed. That’s the number that
they’re going to call if there’s an incident
out there and they want to know what they got and
how to handle it, okay? Or you can use Chemtrec
or Infotel or any 1 of the other emergency
response people, okay? But who knows better about
what they actually have than the shipper? Very important. Your security plan,
mine is different than yours is with
the 7 or 9 CFR. I want to know your
transportation security elements. I want to look at your security
plan and I will try to drag out elements in there that
would meet our requirements and I’m also going to suggest
to you how about putting all of this good information,
do a cut and paste and do it in another tab for us because
I don’t want to go through all that stuff that the
CDC requires, all right, but it’s simple. But your plan, just like
the CDC, you have to have in it a risk assessment, okay,
for transportation purposes. What could happen? What do you have? How could it get away? You’re going to do an
assessment of the risks. You’re going to address
personnel security. You’re going to tell us what
measures have you got in place to ensure John Doe
that you’re going to let him work back
there is a good John Doe. What kind of background
checks are you doing? Your DOJs, your SRAs, all
of this, put this in writing but put it in my
side of the plan so I don’t have to
dig for it, okay? You’re going to address
unauthorized access, yes you’re going to give
me something in general about your keycards
and your locks, and your eyeball identification,
whatever it’s going to be to include how does a visitor
get there in the first place? Okay? If you tell me
on the security plan that all visitors will have
their photo identification checked and you don’t do it
you’ve got a violation right there, you’ve failed to comply
with your security plan, okay? And I’m going to be looking
at it and if I get there and spend 3 hours
or 4 hours with you and all I showed you was
a business card you’ve got a problem. You’ve got a problem. And, of course, en
route security. How can I cover en
route security? I don’t carry it, I
don’t transport it, but you go to that carrier,
Fed Ex most of the time in this country for ground
and air, and you get a letter from them saying that,
hey, I do comply with 49CFR for en route security plan
and I have a plan in place. That’s all you can do. Okay? Because you don’t
carry it actually, you don’t say I don’t pick
up hitchhikers, I don’t stop for lunch, I leave
the truck locked. I do all of these different
things en route because you have to say how do I make my self
confident my product is going to get from A to B, all right? Tell me that the CDC says hey
there’s a form 2 involved, the entity that wants
it contacts them. The entity that sends it, they
communicate back and forth. Tell me all of these things. When you send it and you
give it to that Fed Ex guy and you hold your breath
tell me that, okay, until that receiver
gets it, signs it, an authorizer receiver, and then
calls you back and say I got it. Tell me those things in general. I happen to know
it, okay, excuse me. Put it in writing. Put it in writing. Other requirements that we
have is haz mat training. This comes under 172.704
in our regulation. Everybody has to have
haz mat training. This is a hazardous
material, okay? You’re going to tell us about general awareness
and familiarization. Have you taught that
person how to read the 49CFR when it comes to
a haz mat table? Have you taught that person
how to make shipping papers? If he can’t read the table he
can’t make a shipping paper, okay? Have you told him what kind
of labeling goes on the box, marking goes on the
box, and the box itself? What specifics do we need and
classified as general awareness? Safety, OSHA HAZCOM
Right To Know Program. Function specific,
the person closing that UN certified box has
to close it a certain way with a certain tape
or a certain method. Has that person been trained
on how to close that package and maybe it’s 1 or 2 persons
in the whole operation, they need function specific
training for closing of that package or
documenting a shipping paper. Document that training. Security awareness. We’ve got a free CD
that’ll help you out. It’s 18 minutes long, got
10-minute question at the end. It says look over your shoulder. Be cognizant. In depth security, if
you have a security plan, which the only reason you have to have 1 is you ship any
amount of a select agent. Not just infectious substance, only a select agent requires a
security plan, train the people on the security plan
who have a need to know. So anyone shipping infectious
substances must be trained, to put it mildly. We covered a lot real
quick, obviously, about the shipping papers,
the packaging going on, the training requirements,
the security plan. These are all things
that we inspect for when we go to your facility. This is our help desk
in D.C. They have a lot of very informed people up
there to include the people out of the standards office
and 1 of our attorneys. They’re there during
the course of the day up till 5 o’clock local time,
maybe 4 o’clock, 5 o’clock, and they will be
very helpful to you if you do have any questions. And that’s my information
there and we’ll be sitting on the panel in just
a few minutes so we’ll do questions then. Thank you for your attention.>>Thank you Bill.>>Thank you.>>And thank you
speakers and presenters for providing our audience
with a wealth of information. Now we are open for the
question and answer sessions. If the SMEs please
take your seats. Miranda Scott will preside the
question and answer session.>>Good afternoon. Our first question
for the afternoon, how far in advance should an
applicant submit an application for an import permit?>>Well, I’ll attempt to
answer the first question and allow my colleagues
from APHIS who also issue permits
to answer that question. Typically, we ask that the
applicant submit the application at least 15 days in advance if
no inspection required; however, if you are renewing
your application we ask that you submit it at
least 2 months in advance to prevent your permit
from expiring, to give you an adequate
amount of time to receive that import permit.>>For veterinary service
permitting we ask 6 weeks in advance. We try to get them
done in 2 to 3 weeks. If you want to submit early they
can go in a queue and wait and, for example, you can, you
can apply 2 months in advance or 3 months in advance but it’ll
sit there in the queue waiting to that, for that 6-week period.>>For pest permitting it
varies. Usually the average is
about 60 days; however, if it’s for field release or
requires containment facility, inspections for a first time
inspection it may take longer and certainly contact us by
those contact numbers provided and we can begin to
work with you ahead of submitting an application to determine what
would need to be done.>>For animal importations
we generally ask for 2 weeks in advance. We almost always get
them out sooner than that but in case we have staff
shortages or whatnot we try to get them in 2 weeks. For registration for
non-human primate importers, that’s a much more
difficult and lengthy process. Probably you would want to be
thinking about 3 to 4 months at a minimum for that.>>Our next question, as part of the CDC inspection
process should the information for the inspectors include
occupational health measures and medical surveillance
details?>>As far as the CDC’s
inspection process we’re mainly concerned with biosafety
measures and ensuring that you have the proper
biosafety measures in place for the material that
you’re importing. So those biosafety measures can
include biological, I’m sorry, occupational health measure
that you may have in place and also medical surveillance
that you may have in place for your staff.>>Under 42CFR7154 is
there a requirement to report laboratory incidents
that result in a potential or known occupational exposure
and/or environmental release to the import permit program?>>No, at this time
under 42CFR71.54 that is not a requirement.>>Please clarify the correct
party authorized to issue and sign the permit not required
certification statement.>>For the CDC’s import
permit regulation only applies to applicants or importers within the U.S. Our regulations
do not apply to foreigners so for those specific
regulations, that certification
statement, which is stated in the regulations themselves,
are only for importers within the U.S. so they
would be the recipient. There are times, unfortunately,
where we have an importer who is a sender and a recipient. That’s mainly for individuals
who are collecting samples out in the field and importing
them back into the U.S. for receipt at their laboratory. But as far as our regulations and certification
statement it applies to individuals in the U.S. only.>>Can the APHIS ePermit system
be used for select agents?>>No. There is a separate
select agent permitting process which should go through that.>>Will CBP maintain
the materials at the appropriate storage
temperature as written on the box while
they are quarantine?>>When, when we, when we
intercept any material that, that other agencies
have jurisdiction to, we transfer custody to,
to the regulating agency. We do not have the facilities to actually store any biological
materials at the ports of entry. The only, the only facility
that we, that we have to store any interception
are live birds. That’s the only ones
that we’ve got.>>What if you do not
know the port of entry for the specimens you ordered?>>For the CDC if you
do not know the port of entry we do allow
you to include unknown in that specific section. As far as filling out
the application we do ask that you provide a port of
entry but there are times where we can understand that
you are not aware of which port that the material would enter
so we do allow the ability to include unknown
in that section.>>For APHIS if you
do not know the port of entry there is a function
you can write as applicable.>>Section A on the CDC import
permit application is designated for the permittee, which
has been defined only as the person requesting
the permit. The address entered in section
A must be the physical address where the product will
be worked with or stored. What if the importer or
owner of the materials for which a permit is required
is sending the materials to a third party
storage facility?>>If that importer is
sending that material to a third party they should, that third party
should’ve been included on the final destination
section of the application. Section A is specifically
for the location where the material will
be received initially but we do allow the
flexibility for you to provide us additional
recipients of the material that you may have
collaborational activities with and so in that final destination
section you would include that third party and inform us of that third party
in the next section.>>What is the purpose
of bacteria subculture at least 4 times
before importing?>>That would be for APHIS,
yes, we want to make sure that the cultures
are pure cultures, there’s no contamination.>>Will renewal inspections be
conducted by CDC inspectors? If so, how often?>>At this time we’re
considering inspection, conducting inspections
on a 2-year cycle. Right now that is our plan. I’m not sure of a
definite time beyond this but right now we’re hoping
to do renewal inspection on a, on a 2-year cycle.>>Is there regulation
of sea turtles by any agency other
than CDC, QBHSB?>>We don’t regulate
sea turtles. That’s probably a Fish and
Wildlife thing as it’s an endangered species.>>Okay. For the
web-based application what if an applicant does
not have a middle name? Is the middle name optional?>>Yes the, the middle
name is, is optional. We understand that there
are some individuals that do not have a middle name so that will not be a
requirement for filling out the web-based application.>>Okay. And this question
is for Mr. Stephens. Fed Ex will refuse to ship the
category A package unless we list what is inside. Although it is not required by law they will send
the package back. How should this be handled?>>You could ask them to show
you in the regulation what they, excuse me, you could
ask them the regulation where they are citing. All we’re talking about what’s
in the box as a technical name, it says not to go
on the package. All Fed Ex carriers
know they do not have to see 1 on the package. On the shipping paper,
at the same time, they should see either the
technical name or as showed on the slide earlier, suspected
category A infectious substance. So, again, something must
be in the parenthesis for the technical name on the
shipping paper and, of course, those requirements are in
172.202 section of our book that you could reference him.>>Okay. Is there
an expiration date for the category A shipping box?>>No. Again, if your test
report was done January 2011, we’ll say, that test report and any manufacturing
is good for 2 years. Any manufacturing after, say, February 2013 must have a new
test report associated with it. But if he made a bunch of
packaging and manufactured them and the Label Master or
Uline or anybody else who was holding a bunch of the
packages, it is still a good, viable package as long as you have the current
closure information and test information on it. Not a problem.>>What happens if we have a new
sender during the permit year? Can we amend our current permit or do we need to
apply for a new 1?>>I’m talking for APHIS, yes you can amend your existing
permit to change sender, shipper, or even in cases
of the permittee name.>>For, for the CDC we do allow
the ability to amend permits under special circumstances,
for additional senders that are not included on your
original permit we will ask that you submit a
new application to add the additional
sender to your permit if not originally indicated
on the initial application.>>For pest permitting
they can amend these on a case-by-case
basis but generally if nothing else is changed
we’ll send an amended permit.>>What are some of the
organisms and vectors likely to warrant an inspection when
applying for a VS permit?>>All BSL3 organisms
would require inspection. There are some BSL2s that
would require inspection and we are working on getting
a list of those organisms but they would include things
like PED virus, low path AI, delta coronavirus, swine delta
coronavirus, I’m blanking, lentogenic Newcastle
disease virus, I’m sorry, non-infectious Newcastle
disease virus, that’s the new nomenclature,
and mycobacterium.>>Thank you. Is an import permit required
to import trophies, mounts, rugs, of animal origin?>>In general those items
would be disinfected or rendered non-infectious
prior to shipping, in which case they would
not require a permit. If, on the other hand, they have
not been rendered non-infectious and there’s not an
accompanying statement to that effect then they would
have to be permitted by us, yes.>>If an applicant has evidence
such as a certificate of origin for fetal bovine
serum, will the send, still need to apply
for a USDA permit? Can the certificate be submitted
to justify an exemption?>>Well unfortunately we
would not accept a certificate of foreign origin. We strictly require that fetal
bovine serum certificate used that has to be U.S., Canadian,
or Australian origin, basically which are countries
which are free of FMD. We have something an FSB
certificate is oriented from a known infected
country and they said that they have treated it but currently we are
not accepting that.>>Please discuss the proper
procedures for applying for a CDC worldwide permit. Is it required that all senders
be provided on section B?>>Yes it is required for
all senders to be provided on section B. We do also
have what we call a section B continuation form that allows
you to include multiple senders We understand that there are
some large entities that have over 300 senders
but, unfortunately, for your initial
application we would like to know all the
specific entities that you will be
receiving material from.>>And this question can be
for everyone on the panel. Have you received
fraudulent applications? If so what actions are taken?>>From APHIS I have not seen
any fraudulent applications so far. I have, we have seen a lot
of incomplete applications so we encourage everyone when they submit the
application please be careful to provide every
information that you think that it is necessary to
support your application.>>For CDC, since we’ve
conducted these inspections, we started doing this in
April of 2013, we have come into chances where we have
encountered fraudulent applications or applications
that were submitted incorrectly or with inaccurate
information, I would say. So because of that there have
been situations where we had to revoke or suspend permits because of the information
being inaccurate or situations where we’ve discovered
that places did not exist. So there, there is
that possibility there and we have put in parameters
in our program to ensure that fraudulent applications
or applications with incorrect information
does not receive a permit from our program. So yes, that has happened
before for us and we have since resolved those
types of situations.>>Has the DOT handout
Transporting Infectious Substance Safely dated
2006 been updated?>>No it hasn’t but it’s
as current as it was then.>>Okay. Will the
CDC and USDA continue to maintain separate import
permit programs in the future?>>Because the CDC and the USDA
have separate regulations the programs will be, continue
to be separate; however, we will continue to work
on collaborational projects to improve the communication
among both agencies. For you all’s awareness,
we spent the last couple of days planning and coming
up with challenges and gaps for both agencies and how we
can overcome those gaps together and we’ve also planned
projects, future projects for, for all agencies, actually
that are at this table and how we can move
forward in the future about better collaboration
between the agencies and improving communication. So those are the types
of things that we’re, that we’re considering
to improve the, our efforts going
forward and we’re hopeful that this will also improve
the efficiency of the process for importation and
continue to maintain a safe and secure importation
process for, for everyone.>>Is there a list of infectious
disease biological bacteria virus names to check if you need
to import or a import permit?>>For APHIS, no,
currently we do not have 1. As we mentioned before that
we are trying to create 1 but 1 should remember that there
will never be a complete list. Things are evolving and a
biologigal agent that is not important we do not
consider pathogenic maybe tomorrow it will be. So it will be an,
always a working list, which will be periodically
updated. But currently we do not
have 1 and we are trying to make 1 as soon as we can.>>For the CDC, currently we
have a list but, as we all know, it’s not an all-inclusive list
and we have tallied up agents from different public
health agencies and scientific organizations
so we’ve come up with a general list but
not a all-inclusive list for applicants to use
if they’re filling out our import permit
application but I think everyone
should be aware that, this list is not
all-inclusive, of course.>>For the pest permits we have
listed our regulated article database, which is
an ever-changing list but we encourage people
to just send us an inquiry and then we’ll tell them
the regulatory status.>>If we already have a
transportation security plan for hazardous materials
do we need a separate plan for select agents and toxins?>>No, you would not. The only reason that you would
have 1 is for the select agents in the first place unless
you’re doing something under the 172.802 requirements. So there are some
clickability portions in there where if you’re doing a
PIH, an inhalation or you’re doing mass quantities,
anything 800 gallon package or more, but usually in this
case the only reason you have a transportation security plan is
because you do the select agent. So, by all means,
that 1 should suffice. Now, if you have 1 for other
purposes you better include the information for the
infectious side, okay?>>Are CDC import permits
needed for domestic shipments of Mycobacterium
tuberculosis like MRS?>>I, I think this is
2 different things. For, I will address the
Mycobacterium tuberculosis, for importation of that at
this time we are not requiring domestic approval or transfer
authorization from the CDC for domestic transfer of
Mycobacterium tuberculosis. No for MRS, specifically,
if you are importing MRS into the country we will
issue a condition of issues on your permit stating
that you have to receive additional
approval from our program prior to transferring MRS
to another recipient within the United States.>>For APHIS, excuse me, we are
not permitting MRS at this time and we will provide
Mycobacterium tuberculosis permits.>>Okay. And this is a
2-part question for CDC. How long should an
applicant allow after submitting application
to receive notification from the CDC on whether
the permit is granted? The first case, an
inspection is not required and then the second case where
an inspection is required.>>Well, in, in both cases
honestly you should receive notification 1 way or the other
whether or not you’re going to receive an inspection. Typically, you receive
notification from our program within 7 business days as to
whether or not an import permit, I’m sorry, an inspection
is required. Of course, there are times where it may take a
little longer depending on the specific workload. Now, just for approval
of a permit that does not require import
permit, it usually takes us about 7 to 10 days, a lot
of times less than 7 days if there are is no errors on
that specific application. But, of course, there are many
times where there are errors on the application and it
may take a little bit longer for the permittee to receive
that particular permit because we have to wait on a
response from the permittee so a lot of this also depends
on the permittee themselves, and whether or not they respond
in an adequate amount of time as to how long it would take
us to, to issue the permit without the inspection.>>This question is
for Susan Loring. Does the CDC provide preferred
vendors for failure testing?>>No, we’re not giving
recommendations of who to hire. There, there are a lot of
companies out there that do that type of testing but
there’s no requirement to hire an outside
company either. As long as you have
personnel onsite who have sufficient knowledge about how your own HVAC
system works you can do the tests yourselves.>>The next question is
also for Susan Loring. Is the HVAC failure
testing required annually?>>Our current policy states that once the failure
tests are reviewed and approved there’s
no requirement to perform them again as long
as major changes are not made to the HVAC system or major
problems noted with it.>>And this is a
question for CDC. With regards to the new online
application regarding section E number 4, scientific name, is
there any way to choose all of the below or,
more accurately, all not including
items requiring other specialized permits?>>Some of you are referring to
the new web-based application that will be released very soon. But as of right now selecting
all of the above does not, is not allowed but I do think
that it is an excellent idea that we will take back to the
developers to consider using for applicants who are importing
every single thing possible. So all of the above selection
will definitely be something that we will consider for
our new web-based application so thank you for that,
for that recommendation.>>Do we have to
include en route security and transportation plan
for hand carry samples?>>Oh yes. Hand carrying, obviously
we’re like the CDC, we don’t recommend that. We, we’d much prefer you go to
a certified courier, carrier, Fed Ex, whoever it might be. But there are instances
out there, we know, where universities have distance
situations so when I do a, a check of your transportation
security plan and you explain those things
to me I want to see it in writing, too, to cover it. it may include doing things at
midnight with police escort, we would love to see that
you’ve got a good policy where it’s a 2-man concept
while you’re carrying this, not to go out there alone
and say I can just run down the street 2 miles
with Fed Ex all by myself at 5 o’clock and leave. The package never makes
it, you never make it, let’s have a transportation
security plan that’s going to cover that.>>If my entity ships both
toxins and controlled substances such as DEA-regulated products
are there any restrictions on this being shipped
in the same box?>>A toxin and what in there?>>DEA-regulated substances.>>Yes, we, we need to
keep those separate. Your toxins are going to call for a different haz mat
description, which would fall under normally toxin 6.1
material unless it is an infectious substance toxin,
derived from a living source, et cetera, and it’s still
infectious then you would be changing the name to
infectious substances affecting humans 2814. So yes, by all means,
ship them separately and classify them
correctly as a 6.1 toxin or as a 6.2 infectious
substance.>>That concludes our question and answer portion
of the webinar. Thank you.>>Could I have a chance
to make some comments?>>Sure.>>Okay. If I may, just to
catch people up on things if you haven’t already, the Ebola issue obviously is
a subject of interest today. CDC, all of these agencies
have been working diligently with the DOT on how are
we going to handle this for transporting it away,
whether it’s an apartment full of materials or whether
it’s regular bagged trash of some sort. Obviously, this is not
regulated medical waste. Regulated medical waste and
infectious substances are 1 in the same is how
we classify it. If it is a category B infectious
substance we can change the name when we’re going to waste, to regulated medical
waste and UN3291. Category A, infectious
substance, cannot be changed over to regulated medical
waste, thus, it would have to go out in those same
specification packages that we spoke about before. When the packages, no,
is not large enough to handle the contents of
what you are getting out, we have come up with
working diligently with respected haulers
out there special permits. Special permits are
allowed by the regulation and a little deviation,
a little compromise to where we’re not going to
comply with the regulation but we’re going to
be just as safe with it during the
transportation. So if the carrier can provide
this safe enough for us to recognize it we will
allow a special permit for them to do certain things. Different haulers have
gone in specifically because we had immediate
things to take care of and we provided packaging
exceptions and specifics about how to handle these
Ebola contaminated issues. There is a standard special
permit now out that is on our website, 16 point,
16279 is the number, and only the haulers can
technically have this and they will have to
apply to us to be a party to this special permit in
order for them to haul it in anything but a class 6.2. Class 6.2, as I talked about the
special testing requirements, these are tested requirements
also but to a lesser standard, what we call a packing
group 2 standard. So we will allow
triple packaging with certain tested thick bags. We will talk about disinfectant. We will talk about closing the
package securely and we’ll talk about securing it on the load. Everyone must be trained on the
operation of the special permit who will be carrying it
and also the shipper, which is why I really
want to bring this up because you are going to be still signing the
certification statement that you’re shipping infectious
substances affecting humans and that it has been packaged
and readied for transportation in accordance with
this special permit. So when a hauler comes in
and you’ve got the situation and all, ask for
this special permit. You can get it off the
website, study it, et cetera. But it is out there. Also, the DOT has put out on
our website some general DOT guidance for preparing
your packages for Ebola-contaminated
waste for transportation. So this is on our website also. Please look it up and it’s
general requirements, obviously. And there have been several
haulers who have already come in to ask for party status on
this general special permit, if you will, but currently
because of the situation now in New York, but out in
Texas and here in Atlanta, we had to address these
issues immediately and those special
permits are normally valid for about a month or 2 months. This general guideline or the general special
permit will normally cover about 2 years’ operation
to handle this. So that’s what the DOT
has on their website. If you’re interested please
go on it and you can go to our special permits section
under permits and approvals and type in 16279
and get a copy. Thank you.>>Our division, Deputy Director
of the Division of Select Agents and Toxins will give the
closing remarks, Mark Hemphill.>>Thank you Lourdes. In providing the closing remarks for today’s import permit
webcast, I first want to acknowledge our federal
partners from the Department of Agriculture, Animal and
Plant Health Inspection Service or APHIS, the Department of
Homeland Security, Customs and Border Protection or
CBP, and the Department of Transportation Office of
Hazardous Material Safety, and of course, our CDC
colleagues from the Division of Global Migration
and Quarantine. Thank you for taking the time
out of your busy schedules to participate in
today’s webcast. It’s much appreciated. I also want to recognize
Von McClee, the CDC Import Permit Branch
Chief and Diane Mardon, our Division Training
Coordinator, for making today’s
webcast possible. Thank you. For those that registered
and listened to today’s webcast I hope
today’s webcast provided you with a better understanding
of the regulatory requirements for the importation of
substances, vectors, or animals that contain or
may contain human pathogens or an agricultural pest
or agricultural pathogen. I also hope that this
webcast also gave you a better appreciation of why these
regulations are important for the safety and
security of our country. In summary, you heard today from
the Department of Transportation that they provide
regulations for packaging and labeling requirements for
the transport of pathogens to ensure that those handling
the package during its travel from overseas into
its final destination in the United States are not
exposed to its contents or if that package becomes
damaged during transit and does leak its contents
we immediately know what was in the package so
appropriate steps can be taken to minimize the risk to the
person potentially exposed and to the surrounding
environment. The permits issued daily by
APHIS and CDC help ensure that the recipients
of these packages in the United States have
the appropriate facilities to safely handle and
contain these pathogens. And the U.S. Customs and Border
Protection, along with APHIS and DGMQ inspectors at the ports of entry daily screen
these packages coming into the United States
to ensure compliance with these regulations,
regulations that are designed with the ultimate goal of protecting the United States’
public and our agriculture from the exposure or
spread of these pathogens. This is our second
webcast devoted to the import regulations. We want to hear from you so that
we may improve future webcasts to meet your needs. Those that registered for today’s webcast will receive
an email from [email protected] with a link to a survey. Please take a moment
to complete the survey and provide us your valuable
feedback on today’s webcast. And lastly, a video
of today’s webcast, the PowerPoint presentations of
the speakers, and the answers to the questions
that we received from you during today’s
program will be posted on the website shown
on the this slide in approximately 3 to 4 weeks. All registered participants will
receive an email notification when this material is
posted on the website. On behalf of everyone that made
today’s webcast possible I want to thank you for taking
the time to listen to this important information
and to ask questions. This concludes the 2014
Import Permit Webcast. Thank you. [ Applause ]

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