U.S. FDA EXPORT REGULATIONS – Part 2: Import Procedure & Regulations Overview



now other agencies you will likely have heard of if you are exporting to the US or planning to the US 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 US Department of Agriculture the Department of Justice overseas alcohol alcoholic beverages and lastly I would point out that the Department of Homeland Security US 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 US Customs and Border Protection the role of CBP Customs and Border Protection is very straightforward when products first arrived they fall under the jurisdiction of CBP 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 a 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 u.s. importer so documents like the bill of lading the commercial invoice the packing list those are the types of documents you'll submit to your customer or to your customers bank they in turn 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 a FDA regulated product which is what I assume yours would be FDA's then notified via the entries system so it's notified by customs and border protection that there is an FDA regulated product that is arriving into the United States FDA 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 specific answers that they might want to have or they could choose also to physically go 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 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 of like Los Angeles or Miami or New York now what the FDA does in reviewing your entry 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 a particular importer is the product you're shipping in a category of high risk for example if you're shipping drugs to the nited 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 a fresh or even frozen 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 predictive risk-based evaluation for dynamic import compliance targeting this 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 violent of 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 base that 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

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