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In case food defense-related news has escaped your attention lately, a continuing pattern of intentional adulteration and economic fraud incidents have been reported by both private and government media sources around the globe in 2018. Examples of recent intentional adulteration—economic and otherwise—includes:
- Australian-sourced fresh strawberries, intentionally adulterated with sewing needles, with subsequent copycat metal contamination incidents, were discovered in New Zealand and Singapore, causing consumer injury and significantly disrupting global trade;
- The seizure of 45 tons of quality-expired, chemically-treated tuna from three seafood processing businesses in Spain that marketed and sold the seafood as “fresh;”
- Two Missouri-based U.S. pet food ingredient companies and several individuals were convicted on a misdemeanor count of selling misbranded pet food ingredients for economic gain (i.e. they substituted inferior ingredients)—the company was ordered to pay $7 million;
- A man from Belmont, Miss., plead guilty in a U.S. District Court to diverting a possible 180 truckloads of packaged food and beverage products from 10 companies that were destined for destruction or use in animal feed, reselling these same goods for human consumption on the open market and also falsifying records on the purported “destruction” of these goods;
- A seafood business owner in Newport News, Va., was charged with committing Lacey Act (as amended) and the Food, Drug, and Cosmetic Act (FD&CA) (as amended) violations for blending foreign-sourced crab meat with Atlantic blue crab and mislabeling the crabmeat as “Product of USA;” and
- In December 2018, after a long State food fraud investigation, the New York Attorney General reported the “common practice” of seafood fraud as verified by “rampant” high levels of species mislabeling found in genomically-tested seafood samples taken from New York State supermarket chains.
These examples are what new FDA Food Safety Modernization Act (FSMA) intentional adulteration regulations, soon to be implemented, address. Regardless of the perpetrator’s motive (e.g., terrorism, sabotage, extortion, counterfeiting, theft, or economically motivated adulteration), intentional or unintentional food tampering can cause serious harm to humans and animals.
The arrival of FDA “Mitigation Strategies to Protect Food Against Intentional Adulteration” (or as it’s perhaps better known, “Intentional Adulteration (IA) Rule”), originally published as a Final Rule in the Federal Register on May 27, 2016 (81 FR 34166), will soon usher in new regulatory requirements for large food businesses that must follow this rule. This requires certain businesses that manufacture, process/pack, or hold food must not only be already registered with FDA as a Food Facility, but now must meet provisions of Section 415 of the FD&CA, conduct a formal Vulnerability Assessment, and develop and implement a Food Defense Plan. One of seven FSMA rules, the implementation of the IA Rule has not come too soon. An upcoming implementation and compliance date of July 26, 2019, is nearly upon us. If you must comply and haven’t already addressed required facility tasks that underpin the rule, the time to act is now!
IA Rule Basics
Acts of intentional adulteration may take several forms: acts intended to cause wide-scale public health harm, such as acts of terrorism focused on safety of the food supply, and acts of disgruntled employees, consumers, or competitors and their economically motivated adulteration for financial gain. Acts intended to cause wide-scale public health harm are associated with intent to cause significant human morbidity and mortality. Other forms of adulteration are typically not intended to cause wide-scale public health harm, although public harm results from unintended adulteration consequences that are unknown to the perpetrator prior to an attack. Attacks intended to cause public health harm to both humans and animals are appropriately ranked as the highest risk.