FDA and USDA utilize many extensive and exhaustive regulations, guidance, etc., that coexist to prevent hazards, misbranding, economic fraud, and such from entering our national food supply. These preemptive regulatory programs give us structure on how to anticipate and circumvent hazardous, adulterated, and/or counterfeit food products, but many can be conjoined with our existing supply chain management and domestic positive product-release programs. Regardless of what we have been held individually accountable for by FDA or USDA, we are all required to know and adhere to all pertinent regulations.
One great concern in recent times is misbranding/mislabeling of food products. FDA does not require pre-approved labels. Thus, the onus is on us to ensure proper labeling for whatever part of the supply chain we control. However, there are some regulations that apply to imported foods that help to ensure that all FDA-regulated imported products meet the same standards as are required of domestic goods. Like domestic foods, imported products must be pure, wholesome, safe to eat, produced under sanitary conditions—and contain informative and truthful labeling in English.
One of the most important enforcement pieces for this is Import Alerts. For example, Import Alert 16-04 is a Detention Without Prior Examination (DWPE) with Surveillance; it is one of the many alerts designed to safeguard U.S. borders, markets, and consumers. For a DWPE, an FDA-regulated food item is placed on hold until the importer verifies its compliance. Import Alert 16-04, for example, focuses on seafood misbranding—which has long been a key issue of food fraud. This Import Alert requires that seafood not be misbranded/mislabeled; in other words, the label must correctly and truthfully identify the product. (To view Import Alerts, visit www.fda.gov/Forindustry/ImportProgram/ImportAlerts.)
A 2013 Forbes article, “Fake Fish on Shelves and Restaurant Tables Across USA, New Study Says,” discussed that very issue. Because the species of a fish fillet is virtually impossible to identify without DNA testing, fish fraud often involves the passing off of cheaper species of fish for more expensive and desirable species. To determine if a supplier, or prospective supplier, is on FDA’s list of having misbranded seafood, FDA’s Import Alert website can be consulted. FDA lists, by Import Alert number and country, the processors that are subject to inspections.
Once we have the exact species identified, we then may enlist the data provided by the FDA Seafood List (www.accessdata.fda.gov/scripts/fdcc/?set=seafoodlist). The Seafood List is a searchable compendium from the Regulatory Fish Encyclopedia (RFE) of approximately 1,700 species of shellfish and finfish. It provides listings, by species, of the only acceptable market or common names allowed by FDA on product labels. The list can be searched by the species or common name.
The FDA Seafood List is an invaluable resource for any seafood purchaser/importer. One of the major causes for misbranding of seafood may be traced back to regional, vernacular or colloquial names. In other words the local name, even centuries old, is not a trusted resource for seafood labeling. Some seafood that has been found to be noncompliant are sole (flounders and turbot have been used); lobster (a foreign country name for a species of true crayfish is Red Claw Lobster); catfish (using lower-cost imported fish of Basa, Tra, etc.). The United States Pharmacopeial Convention (USP) states: “Food fraud in the context of food ingredients refers to the fraudulent addition of non-authentic substances or removal or replacement of authentic substances without the purchaser’s knowledge for economic gain of the seller. It is also referred to as economic adulteration, economically motivated adulteration, intentional adulteration, or food counterfeiting.” The motivation may be money but the outcome may be extremely hazardous. As such, labels must identify all allergens, as an anaphylactic allergic reaction may cause severe illness or in some cases death. If the species identity is incorrectly listed, an allergic consumer has no way of identifying a potential harm.
Throughout the U.S. and on our borders, regulators have set sound scientific programs for isolating and rejecting products that do not meet the extensive regulations. We must verify that what we purchase meets or exceeds these regulations at all times.
We must always know the complete history of where and by whom our product is processed; it is our responsibility to know the complete supply chain of all foods. To do so, for seafood, we must validate and verify the exact species that we purchase. We may verify that our supply chain validates the actual fish that is used for the species listed, but we may not rely solely on others to verify our properly labeled seafood products. To do that, we can enlist the use of photos, third-party verification, facility inspections, etc. It sounds exhaustive, but it is important that we do whatever is necessary to ensure we keep our word on product identity.
Additionally, we must ensure that we know and understand all the governing regulations that apply to any product or ingredient we use, the critical limits, the science from which much of it is derived, and our customers’ expectations. It also can be prudent to develop “operating limits” that are more restrictive than regulatory “critical limits.” Imposing our own operating limits, when applicable, allows us some wiggle room to construct an additional barrier for preventing deviations from the scientific, food safety, or regulatory “critical limits.” Many regulatory, academic, and industry groups offer informative classes, websites, alerts/updates, and other valuable resources and information on these food safety must-knows. We must ensure that we are extremely knowledgeable in every aspect of our operations. Continuous improvement is a must, and industry and academia is a great place to start reinforcing and upgrading our programs to always be in compliance with—or exceed—regulations.
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