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The goal of FDA’s Food Safety Modernization Act (FSMA) is to get the food industry, guided by the helpful hand of our regulatory agencies, to better protect the health and wellbeing of our consuming public. We’ve heard it all before – FSMA focuses on preventing food safety issues rather than reacting to food safety issues, perhaps after illnesses or deaths have already occurred. With a heavy reliance on imported food products in the USA, a major focus of FSMA is to create a level playing field between domestic and imported food safety standards.
But when speaking to many in the seafood industry, an industry where imports account for over 80% of the product consumed in the USA, the overarching message is that seafood is exempt from FSMA. Therefore, it is business as usual for the seafood industry. Right?
Confusion regarding FSMA within the seafood industry
“The message at most major seafood conferences is that seafood is exempt from all FSMA requirements, and this simply isn’t true”, says Scott Zimmerman, Founder and CEO of Safe Quality Seafood Associates (SQSA), LLC. “The exemption position is causing quite a bit of confusion, and the mixed message remains.”
Taking a step back, the seafood industry has been operating under HACCP for many years. The industry has done a wonderful job in identifying food safety hazards and building appropriate plans to control those hazards. And that is why seafood companies can kick back, relax, and allow all other non-seafood food sectors to worry about FSMA.
Not so fast.
Is Seafood HACCP enough?
Under FSMA, food importers must adhere to the Foreign Supplier Verification Program (FSVP) requirement – a requirement that the seafood community is exempt from. FSVP goes further than the Seafood HACCP program in that each import firm must have a Qualified Individual to review and validate that the HACCP plans of their foreign suppliers are adequate, and furthermore, must conduct a separate analysis of any potential food safety hazard associated with the transit of those products. Zimmerman states that, “Seafood HACCP only requires one of six affirmative steps to verify compliance, whereas food importers who need to comply with FSVP need to have a multi-faceted approach to supplier verification.” FSMA and FSVP is forcing the food import community to put more skin in the game when compared to seafood.
Could this mean there is potential for change to Seafood HACCP as we know it? If FSMA requires more out of food importers – more than simply importing from a supplier with a HACCP plan – is it possible that Seafood HACCP could follow in FSMA’s footsteps, requiring seafood importers to follow a verification system similar to FSVP? A logical progression would be that seafood firms will need to have a Qualified Individual on the payroll to verify that HACCP plans are adequate. “A number of seafood companies that I work with are hiring me to assist them with developing a more robust verification program”, says Zimmerman. “They’re going through the process, not because the current regulations require them to do so – because they don’t – but they believe it is the right this to do in an effort to have control over their supply chain. I also believe that we will see changes to Seafood HACCP in the near future, so the industry might as well get out ahead of this now.”
Exemption from FSVP does not exempt importers and their foreign suppliers from increased inspections and enforcement mandated under FSMA.
With FSMA comes the possibility of increased inspection and enforcement. Seafood importers have already experienced an increase in FDA visits to their “seafood importer establishments”, the name that FDA warning letters use in place of “office”.
Just recently, a Vietnamese seafood exporter resumed shipments of frozen tuna after being ordered by the FDA to keep their products out of the US stream of commerce. This order came after an inspection of a Long Island, New York based importer that revealed “serious deviations” in its seafood HACCP requirements.
“Inspections are picking up”, says Zimmerman. “Seafood importers are receiving written warnings and are being placed on Import Alert for not complying with CFR 123.12.”
Putting the issue of available resources aside, FSMA requires the FDA to have more boots on the ground overseas, performing physical plant inspections of food processing plants, including seafood establishments. If the plant processes a Ready-to-Eat item, this introduces the possibility of “swabathons”, the food industry granted name for FDA inspections (feels a bit more like an investigation) where hundreds of environmental swabs are taken in order to find listeria on or around food contact surfaces.
When it comes to enforcement, FSMA gives the FDA far more authority under the Mandatory Recall Authority provision. This allows the FDA to mandate a recall when there is a “reasonable probability” of adulteration. Now, it is unlikely that we will see situations escalate to the point where the heavy hand of regulators comes down on seafood companies. All companies will first be given the opportunity to conduct a voluntary recall, and only if the company fails to do so is when the FDA will take further mandatory recall action. But let’s face it – no company would opt out of a voluntary recall and allow for a mandatory recall to happen. That would be brand suicide. So, this enhanced authority, while likely never to come into play, is casting its influential shadow.
In the end, yes, the seafood industry is exempt from some pretty significant pieces of FSMA. However, this does not absolve seafood firms from all things FSMA, especially from the perspective of enforcement of these broader laws that are now in place to protect the consuming public. Zimmerman concludes, “the seafood industry is far from exempt when it comes to FSMA. And while many processors and distributors have already committed to GFSI benchmarked audits, these audits may not address all aspects of the new federal regulations. It is going to be the responsibility of suppliers and importers to address the nuances of these new requirements and determine where compliance gaps may exist.”
“The message at most major seafood conferences is that seafood is exempt from all FSMA requirements, and this simply isn’t true.”
Founder and CEO
Safe Quality Seafood Associates (SQSA), LLC.