Statistics on foodborne diseases are startling, to say the least: Each year, such illnesses are responsible for the hospitalization of approximately 128,000 people, as well as 3,000 deaths and 48 million illnesses, according to the Centers for Disease Control and Prevention (CDC). As shocking as these numbers are, perhaps the more disturbing fact is that such a significant health burden is largely preventable.
In 2011, Congress passed the FDA Food Safety Modernization Act (FSMA), with the chief goal of proactively preventing foodborne illnesses. Significantly, FSMA’s Foreign Supplier Verification Programs for Food Importers (FSVP) shifts the burden of food safety to importers and requires that imported food meet U.S. safety standards.
FSVP requirements can be complex, but they don’t have to be overwhelming, says public health expert Roy Costa in his live webinar for ProfEdOnDemand. In his presentation, Costa lays out the responsibilities of importers, as well as the impacts of FDA requirements on U.S.-based businesses.
Decide Who the Importer Is
So who has to follow FSVP regulations? The FDA does exempt certain firms (and foods) from the ruling. For those not exempt, the FDA defines an importer as “the U.S. owner or consignee of an article of food that is being offered for import into the United States.”
But U.S.-based food supply agents may be on the hook as well. The FDA goes to say that if “there is no U.S. owner or consignee of an article of food 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, as confirmed in a signed statement of consent to serve as the importer under the FSVP regulations.”
Whether it’s owner, consignee, agent, or representative—as far as the FDA is concerned, there’s only one importer. In circumstances where more than one company meets the above definitions, the FDA leaves it to the companies to agree who will act as the single, official FSVP importer.
Important: Each FSVP importer must have a data universal numbering system (DUNS) number. This is a number unique to your business and is typically used for business credit.
Keep Thorough Records for FDA Review
Under FSVP regulations, importers bear a substantial compliance burden, including the responsibility to:
- Determine existing or reasonably foreseeable hazards with each food imported;
- Perform hazard analyses and evaluate each foreign supplier’s performance;
- Evaluate risks due to hazards and foreign supplier performance;
- Conduct necessary supplier verification or compliance checks (by on-site audit, testing, review of food safety records, or third-party vendor documentation); and
- Implement required corrective actions.
Further, importers are required to develop an FSVP for each food they import from a foreign supplier. That means that if the importer trades four food items sourced from three different facilities, the importer must develop 12 FSVPs.
When it comes time for FDA review, the importer must also be able to provide auditors with a food safety plan, documented foreign supplier verification procedures, a thorough corrective action plan, and a Good Manufacturing Practice system.
Keep Track of Dates
FSVP compliance also comes with “you’d better be up to speed by” deadlines.
At a quick glance, it can be easy to think that the required compliance dates are based on the size of the importer, but they’re actually based on the size of the foreign supplier (with one exception). As listed on the FDA’s website, the compliance dates are as follows:
- May 30, 2017: This deadline applied to importers who source from foreign suppliers with more than 500 employees.
- March 19, 2018: This upcoming deadline applies to importers who source from foreign suppliers with fewer than 500 employees.
- March 18, 2019: This deadline applies to “very small businesses” (importers or foreign suppliers), which the FDA defines as businesses whose average annual global sales over the last three years is less than $1 million.
Importers who work with foreign suppliers of varying sizes will need to make sure they balance relevant, disparate compliance dates and plan accordingly. Additionally, note that compliance dates may vary based on type of business and/or qualified facilities.
Food Safety Depends on You
With the onus of ensuring foreign food safety now shifted to importers—and FSVP final rule compliance deadlines either already passed or looming—it’s more important than ever to get your ducks in a row to be able to comply with the new food safety regulations.
As an importer, you are now responsible for assessing your foreign suppliers’ food safety practices, as well as keeping track of their compliance history. That’s why, Costa says, understanding of who controls the hazards and establishing clear communication in the supply chain is so key.