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Now other agencies you will likely have heard of if you are exporting to the U.S. or planning
to: the U.S Department of Agriculture has the Food Safety Inspection Service, and the
Animal, Plant and Health Inspection Service. They also oversee the National Organic Program.
That is the program that if you are producing organic products and would like to become
certified, that program is regulated and overseen by the U.S. Department of Agriculture.
The Department of Justice oversees alcohol, alcoholic beverages.
And lastly, I would point out that the Department of Homeland Security, U.S. Customs and Border
Protection, they oversee the importation and exportation of all products coming into the
United States. Not just food, but computers, automobiles, all types of products ultimately
have the oversight of the U.S. Customs and Border Protection.
The role of CBP, Customs and Border Protection, is very straight forward. When products first
arrive, they fall under the jurisdiction of C.B.P. The U.S. importer of record, your customer
here in the United States, will hire a customs broker who is licensed by CBP to submit an
entry, or filing. And the entry is filed using all of the documents that you as the foreign
manufacturer, you as the exporter will be supplying to your US importer.
So, documents like the bill of the commercial invoice, the packing list, those are the types
of documents you'll submit to your customer or to your customer's bank. They in earned
will provide them to their customs broker, who will in turn submit all of this data electronically
to customs and border protection.
Now, if your product is an FDA regulated product, which is what I assume yours would be. FDA
is then notified via the entry system, so it's notified by the customs and border protection
that there is a FDA regulated product that is arriving into the United States. F.D.A.
will have various options once notified by customs and border protection that product
is arriving.
They will be able to review the entry and determine if they wish to simply release the
product and allow it into commerce in the United States. They could choose to further
review the entry and determine if they have questions about the shipment. A specific answers
that they might want to have or they could choose also to physically go in and inspect
the container.
They could open it up in the port, and they could also pull samples of the product for
testing purposes if they so choose. They also could refuse entry of the product. So that's
sort of the process that FDA will go through when a container arrives. Now they have a
decision tree that is difficult to see on this slide, but if you have a copy of the
presentation, you can enlarge it and see the actual decision tree or the process that they
actually go through, much of it automated when a shipment actually arrives into the
port.
We have 317, approximately 317 official ports of entry in the United States. So your shipments
could arrive, technically, into any of those ports of entry. Most of you will be shipping
to a main port of entry like Los Angeles or Miami or New York. Now, what the FDA does
in revealing your entering depends in large part on a number of factors; the history of
the country, the history of the manufacturer the history of the importer and when I say
history, I mean has there been a problem in the past with a particular country and a particular
product?
Has there been a problem with the particular importer? Is the product you're shipping in
a category of high risk? For example, if you're shipping drugs to the United States, FDA scrutinizes
those more closely. If you're shipping a food product, they will look at the risk level
of that particular food product.
So if it's a fresh juice, or if it's fresh or even frozen seafood, or if it's a canned
product. Those are higher risk products that may warrant FDA taking a closer look at the
entry, and perhaps having interest in actually looking at the product physically, or even
in pulling samples for testing purposes.
FDA did release a software program in 2007 called Predict. Predict The risk based evaluation
for dynamic import compliance targeting is a fancy word for they have a computer program
that lets them input data, and based on the data that they import, it then assigns in
essence a risk level that allows them to decide if they would like to take a closer look at
a particular shipment.
So they will input data about, again, any violative histories of a particular product,
of a particular importer or foreign manufacturer. They may have data from previous shipments
that you've done, a laboratory analysis. They may have data that resulted from an inspection
of your factory in the past.
All of this information then goes into that software and to predict and again it then
helps them determine what risk level they evaluate your shipment to be. And based then
on that risk level, again they can decide if they want to release the shipment with
no further questions or no further information needed, or if they'd like to physically inspect
the goods prior to releasing that product.