FSMA Import Rules
The FDA’s Food Safety Modernization Act (FSMA)
- Signed into law by President Obama on January 4, 2011
- It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it
Foundational rule within FSMA- Foreign Supplier Verification Programs (FSVP)
- Importers of food for humans and animals
- Final compliance date- May 30, 2017
- The final rule requires that importers of foods and or food ingredients perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.
If your business is the Importer of the goods, FSMA and the rules on FSVP require you to-
- Establish a U.S. based operating company
- Have an email address of your U.S. based operator
- Have the unique facility identifier of your U.S. based facility (the FDA has determined that an acceptable facility identifier is a DUNS number). A DUNS number can be obtained free of charge via the Dun and Bradstreet website
- Have the FDA registration number of the facility producing the goods, as well as your FDA registration number as the importer and holder of goods
Note that all of these details will need to be provided with the goods on arrival into the U.S. from the 30th of May 2017. Failure to provide these details may result in the goods being impounded on arrival into the U.S., and could cause significant interruption of supply.
You as the FSMA Importer, are required to have the following documents available to the FDA within 24 hours if and when audited-
- A full copy of the Hazard Analysis that for each product you are importing into the USA
- Where a hazard has been identified within your Hazard Analysis, full list of each of the Preventative Controls that are being applied to control that hazard
- The name and qualifications of the individual who conducted the Hazard Analysis
- A full copy of your Supplier Verification Procedures, and a full copy of the verification activities that are being conducted for each item you are importing
Please note that each of the documents above need to be marked with the date on which the document was completed, and signed by the qualified individual who was responsible for completing the analysis.
Going forward, it will be required that the Hazard Analysis be reviewed, and as necessary updated, no less than every 3 years, when changes or incidents occur, or when new information becomes available.
Please note: This is a brief overview of the requirements for Importers of food products into the United States. For more detailed information please click here.