The Food and Drug Administration (FDA) is changing its computer system to utilize more technology and streamline the process of differentiating between high risk food and drugs, and low risk foods and drugs. The Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system is replacing the Operational and Administrative System for Import Support (OASIS) system.
As can be told by the acronyms the new system will use computer technology to target foods that are high risk and use less "human" based assets. There will be less people deciding what might be dangerous and more computers deciding what might be dangerous. At the same time they are moving more inspectors into the field overseas. What this means for importers can be both good and bad depending on the importer. The FDA stresses it depends on the accuracy of the data provided to them which will decrease the need for detentions, reviews, exams and sampling.
The more accurate the data provided to the FDA the less likely that goods will be reviewed. For importers that have good data from the manufacturers and the information provided is “consistent, accurate and complete,” then the inspections, request for documents, and reviews will be fewer than the previous system. They emphasize the more the importer concentrates on insuring "CAC" the less exams, sampling, and detention there will be.
Most importers are not aware of the data we provide the FDA for their imports so I will briefly explain it. There are three basic data elements that the FDA is looking for to decide the risk, the 1) Manufacture Identification, (MID), 2) the PN registration number, and 3) the product code. The FDA wants these data elements to be “consistent, accurate and complete.”
The Manufacture ID is a code used to identify the manufacturer of the food product. The FDA conducts routine inspection of overseas food facilities, therefore it is important to know that your manufacture is producing safe food. The MID is constructed by using the address of the facility. The first two letters are the country code, the next three letters are the first three letters of the manufacturer’s first name, the second three letters are the first three letters of the manufacturer’s second name, the next four digits are first four digits of the manufacturer’s street address, and the last three letters are the first three letters of the manufacturer’s city.
For example if the company was: Food Makers Inc. 123 Main Street, Big City France. The MID would be FRFOOMAK123BIG. This is simple but many times shipper give different information on the bill of lading, the commercial invoice and their web site as to their address and company name.
The FDA claims that it is typical for one manufacturer to have 6 different manufacturer’s ID codes. The problem is that overseas address systems are different than our own. Some times the letter from one language will translate to different roman characters by different people. Furthermore, many overseas producers have several names they use concurrently for their businesses. It is often hard to differentiate on the invoice between town, county or province.
For example, Aziendia Agricola, precedes many vineyard names. But many times they will use the commercial name of the vineyard on invoices. To be consistent it would be best to get a copy of the exact name and address as they filed with their Prior Notice registration. It is also important though that the information they used to filed with the FDA prior notice be accurate.
It would be good for us to go over with you and the information given by your supplier to make sure we are on the same page and that we have consistent information used to file. Even if we have been handling you products for many years it will be worth the time to spend a little time ensuring that we have and file using accurate information. Then in turn we would help to ensure that your products continue to enter the U.S. smoothly and quickly.
The third area that we should also check to help insure that your product are imported easily is ensuring we are using the proper “Product Code.” The product code is two digits three letters and two more digits. The first two digits are the general product division. The first letter and last two digits are the specific product divisions. These are pretty self explanatory as long we have a decent description of the goods then we can figure these out consistently. It is the second two letters where accuracy and consistency issues arise.
The first letter is the packaging that is used. Many invoices do not specify the packaging method. It is important that we get this information from your supplier in order to use the proper product code. The second letter that poses problem represents the sterilization method used. The possible sterilization methods and packaging codes are as follows:
Packaging: Sterilization Method:
A- Fabric Acidified
B- Ceramic Earthenware Aseptic Packed
C- Glass Commercially Sterile
D- Laminated Cultured/ Cure
E- Metal Heat Treated
F- Paper Not Specified
G- Plastic Naturally Dried
H- Non Flex Plastic Package Food Not Commercially Sterile
J- Wood Pasteurized
M- Multiple Containers Raw, Frozen
V- Vacuum Packed Raw, Fresh
W- Wax Raw Refrigerated
Y- Not Specified Ultra pasteurized
Based on the specific food it is easy to foresee that it should fall in under a particular sterilization method. If sterilization method and packaging method do not match up with the food it is easy to see why the food should not be admitted into the US. The broker will need to have accurate information from the importer, from the supplier, or have detailed information on the invoices. Especially where is not obvious, however, for a bottle of beer, we would know that it is packed in glass and cultured. But other items are not so obvious.
If the broker can get this information they can help you to have fewer problems with the FDA. Most customers never have any problem and never know what information we file to clear their shipments. However, it would still be a good idea to insure we are using the accurate data to insure we have no problems in the future. On the other hand customers who have had problems should talk with us to get the right information and eliminate problems with the FDA.
The new system can really help the good importers insure that they have fewer problems with the FDA and that products are delivered faster and safer.