What Do Class I Recall Trends Tell Us About Food Safety Management?

Over the past five years, the U.S. food industry—and those supplying the U.S.—have seen regulatory expansion in food production and handling systems with the advent of the Food Safety Modernization Act (FSMA). But, what impact have the mandated controls and management system requirements had on keeping contaminated food out of the marketplace. As 2018 draws near, TUV USA was curious to examine Class I recall trends of the past five years as a barometer of enhanced food safety management success.

Since 2013 (pre-FSMA implementation), the number of Class I recall events has steadily climbed, including the number of recalls for (potential) contamination from Listeria monocytogenes, which remains on the rise in 2017.

2013 – 2017 Class I recall trends observed via FDA Enforcement Reports¹ include the following:

• For 2017 (through October 31), 277 Class I recall events were initiated, recalling 966 products

• Steady increase in the number of Class I recall events from 2013 - 2016 at a rate of 21% and 25% for years 2015 and 2016, respectively

• Undeclared allergens and Salmonella, Listeria monocytogenes, or E. coli contamination account for 90% or more of products recalled under Class I events

• Sharp increase in Class I recalls for pathogen contamination (notably L. monocytogenes) over undeclared allergens in 2016 and 2017 (to date) as compared to previous years

• Recalls for L. monocytogenes increased by nearly 50% in 2017 (to date) and 140% in 2016 as compared with 2015

• Increased recall events by other countries in 2017 as compared with previous years


¹ U.S. Food and Drug Administration, Enforcement Reports




By: Ashley Smejkal & Lori Carlson

November 2017



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The following line graph depicts trends in Class I recalls for all events, undeclared allergens, and pathogen contamination from 2013 – 2016.

In consideration of these trends, what can we glean from increased Class I recalls, the impact of FSMA, and ever-increasing number of production sites certified to a GFSI benchmarked food safety management scheme?

• Is increased environmental monitoring as required by new versions of GFSI schemes and FSMA’s Preventive Controls regulation helping detect L. monocytogenes in the plant environment and sequester potentially contaminated products?

• Are improved labeling verification systems and allergen control monitoring catching undeclared allergens at an increased rate?

• Is increased food safety training resulting from Preventive Controls regulation helping producers and manufacturers better recognize hazards and identify them both within their plant and across their supply chain?

• Is an increased commitment to growing a food safety culture encouraging company leadership to invest in hazard monitoring and detection through equipment, testing and staff training?

• Is the recall reporting process for companies, including reporting from other countries selling products in the U.S., becoming more streamlined and understood?

The increase in Class I recalls is understandably the result of numerous improvements in food safety management over the past 5 years resulting from heightened regulation, increased scheme rigor, and an alignment of both to keep potentially harmful products out of the hands of consumers. Will 2018 and beyond see the food industry on the same trajectory of increased Class I recalls and pathogen detection; how will food safety priorities of the next 5 years shift and what impact will this have on recall trends?


About the Authors

Lori Carlson provides independent technical writing, training and consultation services to the food and beverage industry. She has over a decade of experience in verification and validation, risk assessment, food safety and quality management systems, GFSI benchmarked schemes, regulatory compliance, and third party certification. Lori has authored numerous white papers, magazine articles and guidance documents and has contributed to the development of various food safety standards and food professional training courses for GFSI scheme owners and certification bodies. Contact the author through LinkedIn.

Ashley Smejkal supports TUV USA’s Food Division team as Project Coordinator ensuring excellence in client satisfaction for new and renewal certification audits.

Ashley has more than a decade of experience in customer service and sales within the food service industry. Additionally, she served in administrative and marketing positions for a start-up biotechnology company helping to launch new products in the medical device industry.

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