An upward trend in U.S food recalls during the past decade and a recent spike in recalls due to hidden allergens underscore the importance of global food supply chain management and Good Manufacturing Practices (GMPs).

The complex global food supply chain, involving the sourcing of multiple ingredients from numerous suppliers, is often linked to a higher risk of recalls due to microbial or chemical hazards. To combat the upward trend in recalls and improve the safety of imports, the Food and Drug Administration (FDA) is expected to implement several key regulations of the Food Safety Modernization Act (FSMA) this year to bolster preventive controls and supplier verification.

Surge in Allergen Recalls
Since the implementation of the Food Allergen Labeling and Consumer Protection Act (FALPCA) in 2006, undeclared allergens have been a leading reason for FDA food recalls.  In fact, the annual number of FDA food recall events due to the “Big 8” allergens (wheat, crustacean shellfish, eggs, fish, peanuts, milk, tree nuts and soybeans) steadily increased between the years 2006 and 2012. The major allergens triggered 34% of all FDA food recalls in 2014 and were the leading reason for recalls of FDA-regulated food products during the first half of 2015.

During the first six months of 2015, undeclared allergens triggered more than half of all food recalls recorded within the FDA Enforcement Report. In fact, greater than 150 food recall events were attributed to undeclared peanut or almond in cumin or products containing cumin. The initial spike in cumin-related recalls subsided in February but later resurged. In fact, 64% of all recalls due to undeclared allergens in cumin occurred between April and June.

The detection of high levels of peanut protein in cumin was first reported by Canadian officials last November. Economically motivated adulteration was suspected as the source. The incident prompted demands for increased testing of cumin, but subsequent testing found lower levels of peanut protein, which suggested unintentional contamination. The majority of recalls of cumin or products containing cumin this year were due to the potential presence of an allergen, but not necessarily the detection of an allergen.

The allergens most commonly identified in FDA recalls this year include peanut, milk, soy, egg, wheat and tree nuts. Due to the cumin issue, seasonings were the food product type most commonly recalled due to allergens so far this year. Bakery products, confectionery products, dairy products and sauces were also commonly involved in allergen-related recalls.

Microbial contaminants and other reasons
Based on a review of FDA food recall data for the first six months of 2015, the leading reasons for food recalls included: undeclared allergens (53%), microbial contaminants (25%), non-allergen labeling errors (7%), improper GMPs (5%), and foreign matter (4%).

Within the past decade, several infamous foodborne illness outbreaks and hundreds of food product recalls have been attributed to a microbial hazard associated with a single ingredient, typically spices or nuts.

To date, food recalls due to microbial contaminants are on pace to equal the total number of FDA food recalls recorded in 2014 due to microbial reasons. Listeria monocytogenes, Salmonella, Staphylococcus aureus, and Clostridium botulinum were the microbial pathogens most commonly identified in FDA recalls this year.

In addition to undeclared allergens and microbial contaminants, labeling errors (other than allergens), foreign matter, and processing errors round out the top five reasons for FDA food recalls this year. In comparison to last year, the number of recalls due to chemical contaminants such as heavy metals, drug residues and pesticides has declined.

FSMA rules target supply chain risks
While food safety risks associated with the global supply chain are well known, the recent cumin incident serves as a reminder that firms must actively monitor their supply chain for intentional and unintentional adulteration.

In recent years, several cases of large-scale outbreaks and recalls have been linked to a single ingredient supplied to a myriad of manufacturers. Examples include events involving Salmonella in nuts and spices, and melamine in wheat gluten that resulted in recalls of hundreds or thousands of finished food products.

A surge in recalls and foodborne illness outbreaks prompted legislators to develop the Food Safety Modernization Act (FSMA). Under the law, the FDA must implement regulations impacting foreign and domestic firms, including rules for preventive controls, the accreditation of third-party auditors, and the Foreign Supplier Verification Program (FSVP).

Later this month, FDA will finalize the FSMA rule for preventive controls for human food, which will require facilities to conduct a hazard analysis and implement a written food safety plan. Moreover, the rule would revise the current Good Manufacturing Practices (cGMPs), including a provision to prevent allergen cross-contact during manufacturing.

Final rules implementing the FSMA requirements for a Foreign Supplier Verification Program (FSVP) and the accreditation of third-party auditors are due by October 31, 2015. The FSVP final rule will require U.S. importers to conduct risk-based foreign supplier verification activities. To ensure proper control of hazards, import verification activities might include a review of foreign supplier food safety records, sampling and testing, on-site auditing, and other appropriate methods.

To facilitate the inspection of imported products and foreign food facilities, FDA will issue a final rule for the auditing and certification of foreign food facilities and food. The rule would establish requirements for accreditation bodies seeking recognition from FDA, and requirements for the accreditation of third-party auditors.

FSMA authorizes the FDA to impose a mandatory food recall if the responsible party declined to issue a voluntary product recall. FDA can impose a recall if the agency suspects a product is adulterated, misbranded or a potential health risk. The FSMA food recall authority applies to all registered facilities that manufacture, process, pack, distribute, receive, hold or import food. Although the FDA was granted this authority in 2011, the agency has exercised this mandate only twice.

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