The U.S. Food & Drug Administration’s (FDA) new Foreign Supplier Verification Program (FSVP) for Importers of Food for Humans and Animals is in full force, and food importers must be compliant or face significant penalties. Unfortunately, many companies don’t know (1) that it exists; (2) that they fall under the regulation; and (3) what it means.
As nearly all coffee consumed in the United States is imported, FSVP is significantly relevant to the coffee industry. Coffee importers must be aware of the new regulation, and ensure that they’re compliant.
“Educate to enforce”
Like many new federal regulations, the FDA is offering companies time to learn what it means to them, and implement processes to become compliant. This period – where the regulation is in full effect, but isn’t being enforced yet – is commonly known as “educate to enforce.” While inquiries are already being made, the penalties for non-compliance aren’t being handed out yet. But they will be at some point soon, and Welke Customs Brokers USA has gone on a something of an educational tour, offering seminars throughout the country on how coffee importers must become compliant with FSVP.
What’s the purpose of FSVP?
On the surface, FSVP, a stipulation of the Food Safety Modernization Act (FSMA), which was signed into law in January, 2011, requires importers to have processes in place to ensure that food coming into the United States is produced in a manner that provides the same level of public health protection as U.S. regulations require. Hard to argue with, as U.S. regulations for the public good are as stringent as anywhere else in the world.
Like most governmental regulations, much of the onus in the requirement is on those playing by the rules to implement compliance processes, to weed out bad actors. Under FSVP, every food import coming into the country must fall under someone’s responsibility – and it needs to be a legitimate entity, that is then liable for any malfeasance. We have not yet heard many instances of companies being identified as the problem, as the FDA is still in an educational phase on the regulations, but there are certainly a few, as in the Canadian “non-resident” importer whose address of record was a condo in Florida. As you can imagine, that operation was shut down fairly quickly.
Who’s affected?
Which companies fall under FSVP is the question that has caused significant confusion. The FDA’s web site lists tens of thousands of companies as “resident importers,” and we’ve found all kinds of problems with the list. There are companies that don’t import, companies that are out of business and companies whose role in the supply chain shouldn’t make them the FDA importer.
That last category is the one to focus on, however, as we’ve learned that many of the companies listed as falling under FSVP are so only because somewhere along the line they were listed as the importer-of-record on an entry. Warehousing companies, trucking companies, Customs brokers, even retail franchisees have made the list, and are targets for an FSVP audit. Unfortunately, it doesn’t even have to be you who filled out the form. If your company is in the FDA’s database as an importer, you’re on the hook (for now).
This leads to two paths, of course: (1) you’re actually a coffee importer, and need to take the necessary steps to become compliant with FSVP; or (2) you’re not a coffee importer, and need to get yourself removed from the list.
What steps should companies be taking?
If you’re the importer-of-record, there are a few options for determining your foreign suppliers’ compliance to FSVP, enabling import into the U.S. Those options include:
Importers have the flexibility to tailor supplier verification activities to unique food risks and supplier characteristics. The options include:
- Annual on-site audits of the supplier’s facility – generally required for higher-risk foreign suppliers. However, the importer can choose another means of verification provided that the importer documents that the alternate choice provides adequate assurances that the foreign supplier is producing the food in accordance with applicable U.S. safety standards.
- Sampling and testing
- A review of the supplier’s relevant food safety records
If you’re not an importer, but were somehow listed as an FDA importer at some point, unfortunately companies are experiencing a bit of a challenge trying to get their name off the list. Your first step is to contact FDA, though, which you can do through www.fda.gov.
What are the penalties, and when will they be enforced?
For companies looking to follow the law, what if something goes wrong? There are varying levels of penalty for non-compliance, but it is important for importers to work on FSVP-compliant policies now. Yes, things happen, but having a compliance policy in place is the most effective way to mitigate stricter penalties in the event of a problem. Promptly taking corrective actions if you determine that a foreign supplier’s processes aren’t up to U.S. standards is critical.
Penalties range from discontinuation of imports from the foreign supplier until the problem has been adequately addressed to seizure and injunction to significant fines. At the very least, non-compliance will create a roadblock in your supply chain, as FDA field staff have the authority to detain import entries that violate the rules – either the specific product, or the products of a specific foreign supplier.
While it’s not being fully enforced yet, FSVP is in full effect. Given the “educate to enforce” leeway that FDA has granted, the time is now for coffee importers to get to know the regulations, get a firm handle on your role in the supply chain, and make sure you – or your importers – have compliance processes in place.
More information on FSVP is available at www.fda.gov.
