In the United States, the U.S. Food and Drug Administration (FDA) says, “about 15% of the food supply is imported from more than 200 countries or territories, including 32% of fresh vegetables, 55% of fresh fruit, and at least 94% of seafood Americans eat each year.”
As a result, the feds have taken a closer look at imported food over the last decade, starting with the Food Safety Modernization Act (FSMA). Near the end of 2015, the FDA published its final rule for implementing the Foreign Supplier Verification Program (FSVP), a significant provision of FSMA.
FSVP mandates that anyone importing food into the United States implement specific risk-based actions to ensure the products meet U.S. safety standards. On March 19, 2018, most imported food shipments became subject to FSVP requirements. TraceGains spoke with regulatory attorney Marc Sanchez to help clear up some of the confusion surrounding FSVP.
How the rule applies is one of the first questions companies ask about FSVP. Various parties can be involved in a shipment as it enters the country, so how does the law define the importer? Since the FSVP rule lays responsibility at the importer’s feet, the logical first step is to identify the importer. Is it the buyer, the owner, the consignee, or maybe even the broker?
According to Sanchez, the U.S. owner or consignee is the person in the United States who owned the food at the time of entry, purchased the food, or agreed in writing to buy the food. This definition might seem straightforward, but it can get more complicated quickly.
“For example, suppose there’s no U.S. owner or consignee at entry,” Sanchez points out. “In that case, the importer is the U.S. agent or representative of the foreign owner or consignee, as confirmed in the signed statement of consent. Companies need to have an agent if they import into the United States.”
The FDA allows brokers, on behalf of their clients, to import food into the United States. In this case, then, who’s the importer? Brokers often assume they’re not responsible for the imported food since they don’t see or touch it. On the other hand, the broker’s clients typically believe they’re not responsible because the broker is bringing the food into the country.
“When in doubt, look for the individual with a financial interest, or whoever controls or interacts with the foreign supplier,” Sanchez adds. “You’re not looking at the intermediaries, but at the consignee, owner, or U.S. agent. The takeaway here is to document extensively to ensure that if the FDA questions who the importer of record is, you can provide adequate proof.”
However, it’s worth noting that the FSVP rule allows companies to hold importers accountable for ensuring the products they bring into the country meet the same safety standards as domestically produced foods. Sanchez says that’s a significant shift in the way companies have done business in the past.
In the wake of the pandemic and ongoing safety worries, the FDA has issued several temporary policies for food manufacturers and importers – one of which is the relaxation of FSVP onsite audit requirements. This guidance offers details about the specific cases under which the FDA won’t enforce onsite audit requirements. It also spells out conditions for when it would allow receiving facilities and FSVP importers to resume onsite audits.
For more information about this complex provision of FSMA, check out our eBook, “FSMA FSVP Guide” here.
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