WHY IS IT OF UTMOST IMPORTANCE IF IMPORTING FDA MERCHANDISE?

May 27, 2017 will be the start date for the US FDA to begin implementation of the Foreign Supplier Verification Program or FSVP. Per FDA website “The final rule requires that importers 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.” Further, FSVP “…is a program that importers covered by the rule must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls of produce safety regulations, as appropriate, and to ensure that the suppliers food is not adulterated and is not misbranded with respect to allergen labeling."

The FDA website cited below bullet points actions which importers are responsible to undertake:

• Determine known or reasonably foreseeable hazards with each food
• Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance
• Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities
• Conducting supplier verification activities
• Conducting corrective actions

FDA notes that “Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food…” An FSVP is needed for all food coming to the United States. If an importer sources one particular food from numerous suppliers, each supplier will need an FSVP.

So who is the FSVP importer? Quoting the FDA website citation below “For the purposes of FSVP, an importer is the U.S. owner or consignee of a food offered for import into the United States.” It is important to note that if there is no U.S. owner at the time of entry into the U.S., then the foreign owner of the food must appoint a U.S. agent. Per the Federal Register published November 27, 2015, “If the article of food has not been sold or consigned to a person in the United States at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry. JAS Forwarding USA Inc. cannot fulfill this function."

What to do? Now is the time to get familiar with these regulations. First, confirm if you are importing food. If so, then focus a great deal of attention on developing a process for FSVP for each supplier. It is important that each importer check the rules and confirm if they are by definition the FSVP importer. Also note that starting on May 27, 2017, each importer’s broker will need for each line of food product importing into the U.S., the name, contact information, DUNS#, and FDA registration number of the FSVP Importer. This information will be reported in ACE at time of entry starting on May 27.

While it is reasonable to expect a soft launch with regards to compliance and targeting by FDA, it is important to proactively work toward compliance quickly. If you need help determining what this means for you, contact JAS Forwarding USA Inc. Compliance today and we can help!

https://www.fda.gov/food/guidanceregulation/fsma/ucm361902.htm

https://www.federalregister.gov/documents/2015/11/27/2015-28158/foreign-supplier-verification-programs-for-importers-of-food-for-humans-and-animals

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