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So, starting off with the Bioterrorism Act, this came into place after the events of September
11th in the U.S. when our government, FDA, realized we really don't know who's shipping
food into the United States, nor do we know who's producing food within the U.S. There
is no central registration or database of companies.
Shipments would arrive right into our ports, be taken off the ship, put into the port,
waiting for FDA to release them. And at that time you would, FDA would learn what was in
the container. So effective in October of 2003, FDA required a registration. Companies
were required to register what's called their facility or your actual factory, or your warehouse.
In addition they, companies, are required announcement what's called prior notice, which
is a notification that you must give to FDA electronically saying, we have a shipment
that's coming to the U.S. This is when it will arrive, this is what's in the shipment,
etc. I'll touch on that in a moment.
If you were exporting to the US in 2003, you would have had to have registered by that
deadline of December 12th. If you are just starting and just planning to export, you'll
need to register before your first shipment goes to the U.S.
And again, it's registration of a physical location, or what's called facility, that
manufactures, processes, packs, or stores food or beverages. And again, when I say food
or beverages, that also includes dietary supplements.
So, it's not an office. It's not your, if you're a broker or a trader, it's a physical
location that's producing or warehousing a food product. FDA gives each of the registrants,
each location an eleven digit number, and this applies to both U.S. and foreign companies,
so a company in the U.S. must also register.
The one difference is foreign companies must also designate what's called a a U.S. agent.
And the U.S. agent's role is to act as a communications link between FDA and the foreign company.
They must be physically present in the U.S. and they must be available 24 hours a day,
7 days a week to answer any questions that FDA may have of the company exporting the
product.
The agent -- as the word agent implies -- is not a commercial agent, but it's an agent
for the purposes of FDA. The agent is answering questions FDA may have as though they are
answering for the manufacturer or for the registered firm. FDA also looks to the agent
for scheduling inspections. FDA wants to come to Vietnam to inspect your factory, they will
contact your U.S. agent and give them a notification and a letter indicating that they would like
to come inspect your factory.
Your customer may act as your U.S. agent; again, as long as they're in the US, as long
as they're available 24/7. However, keep in mind that if you have more than one customer
and your doing shipments to lots of different customers, FDA is always going to call that
one U.S. agent that you designated in your registration.
So if you have a problem with a shipment that you've done to customer #2 or 3 and customer
#1 has been listed as your U.S. agent, FDA will being calling that customer #1 to ask
about the shipment that you've sent to customer #3. So you do need to careful, if you have
many customers, in choosing your agent.
We do, obviously, as isstated in our materials. And here we do act as U.S. agents. We're U.S.
agents for about four thousand food and, food companies -- food and beverage companies around
the world. Registration. Once your registered, FDA provides just a number; it's an eleven
digit number. We provide -- as a company -- a certificate indicating the date you've been
registered and indicating that your registration as of that date is in good standing.
It can be provided to your buyers in the U.S. to verify that you have indeed registered.
The information that you're given by FDA is actually just an eleven digit number. They
don't give you any document that you could really present to any customers. Companies
should register on their own. You are testing in a registration that all the information
is accurate and complete, and doing it for there's a, registering a factory without their
knowledge is not permitted.
Each factory needs their own number. So, let's say your company has three locations, you
would register all three locations if you were producing food or beverages at those
three locations for the US. Now because brokers, traders, transporters, they don't technically
manufacture a product they are not required to register.
Warehouses are required, whether it's a public warehouse, or your own private warehouse,
or warehouses, they are required to register. So you may have three factories and one warehouse,
you would register four facilities and have four different numbers.
When the regulation came out in 2003 FDA estimated around 420,000 companies around the world
would need to register.
As of about two years ago, 367,000 companies have registered, and 216,000 of those are
foreign companies.
Now to give you an idea of how active FDA is, because of budgetary and personal constraints,
it's very hard for them to get out. Obviously, you can't possibly inspect that quantity of
In their best year, which was in 2007, FDA inspected a little over one thousand companies
outside the United States. So, a pretty small number when you figure 216,000 are registered.
To give you an idea of some quick numbers here, Vietnam, quite a few companies companies
are registered with FDA. Over 5,000 companies are registered with FDA. And I can tell you
from experience, a lot of those are in the seafood sector.
But, you know, you can have some comparisons here. China has 20,000, over 20,000, registered
firms. Canada, bordering the U.S., 14,000. So really for southeast Asia, Vietnam has
quite a large number, and that's fairly indicative of how active the exports are here.
The second section of the regulation prior notice requires companies to submit information
to FDA in advance of a shipment arriving in the United States. So you have to notify FDA
that you have a shipment coming so that they then can decide if they want to inspect that
shipment prior to it actually arriving into the port.
Prior notice is not an approval. Once you submit the shipping information to FDA you
get back a bar-coded confirmation. But that doesn't mean that it's an approval; it doesn't
mean FDA will inspect or won't inspect.
All it means is, you have told FDA you have a shipment coming, and they have acknowledged
that you submitted the information you're required to submit.
This bar-coded confirmation, you don't have to send it along with your shipping documents,
but in the case of sending samples--For example, if you're sending over a box with some food
samples to the US to a potential buyer, or to a trade show, I would strongly recommend
you put a copy of the prior notice with the actual package.
Before the prior-notice regulation existed, as I indicated before, a container would arrive
right into the port, maybe even come off the ship, go into a warehouse and then FDA would
be told there's something for them to inspect or to review. With the prior notice they know
far in advance that a shipment is coming, and they can plan and use their resources
accordingly, to inspect or to take samples, because they, again, know in advance what's
coming and they can better screen what's arriving and decide if they are indeed going to inspect.
There are time frames, minimum time frames for filing prior notice. If it's going by
air cargo, four hours. If it's coming by sea, eight hours. If it's coming by mail; express
carriers; DHL; TNT; FedEx; you should file a prior notice before your shipment departs.
Put it with your package. Anyone can file prior notice as long as they have knowledge
of the shipment details.
In order to file it, you'll need to know the name of the manufacturer, their registration
number, the port of entry, the estimated time of arrival, the importer's name and address,
the quantity of what's in the container, the product code, the FDA code, the harmonized
tariff schedule code. So all of that information gets submitted to the FDA then they generate
this confirmation.
We offer a service where we do help with prior notice filings. You can do it directly on
our website in Vietnamese and we will submit the data to FDA on your behalf and we'll return
to you the confirmation. And our turnaround time is about 30 minutes.
So once you submit that information to us we'll submit it very quickly and get it back
to you.
You will need to supply your eleven-digit number for your facility. And if you're a
trader or a broker and you're buying from other companies, you'll need to find out their
number so that you can submit their number along with their name and address when you're
submitting the prior notice.