Last week, the U.S. Food and Drug Administration (“FDA”) classified a large-scale recall of more than 55,000 pounds of frozen blueberries that may have been contaminated with listeria monocytogenes as a Class 1 recall,[i] its most serious risk level.[ii]This recall highlights a critical reality for the produce and processed food industries: contamination events can arise at multiple stages of the supply chain, and both growers and food manufacturers have distinct but complementary obligations under FDA’s Produce Safety Rule and Current Good Manufacturing Practices (“CGMP”) regulations, which are designed to prevent such events.

Produce Growers: The Produce Safety Rule

FDA’s Produce Safety Rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits (such as blueberries), vegetables, mushrooms, and sprouts intended for human consumption.[iii] The Produce Safety Rule addresses key areas where contamination can occur at the farm level, such as:

• Agricultural Water. Water used in harvest operations, including irrigation, washing, and cooling, must meet safety standards to avoid introducing harmful microorganisms. Growers must conduct annual pre-harvest agricultural water assessments evaluating the nature and location of water sources, application methods, and surrounding environmental conditions.[iv]
• Worker Health, Hygiene, and Training. Farms are required to prevent contamination from workers with communicable diseases. Among other things, the rule has specific requirements meant to ensure cleanliness and avoid contamination. It also requires all personnel who harvest or handle produce, along with their supervisors, to receive food-safety training.[v]
• Biological Soil Amendments. The rule establishes standards for the use of raw animal manure and compost as soil amendments, given that untreated manure is a potential source of listeria and other pathogens.[vi]
• Domesticated and Wild Animals. Growers must take measures to prevent animal intrusion into growing areas and inspect for evidence of fecal contamination during the season.[vii]

Food Manufacturers: CGMP, Hazard Analysis, and Preventative Controls 

Because frozen blueberries are a processed food product,[viii] the manufacturing facility responsible for freezing, packaging, and holding the product is subject to FDA’s CGMP, Hazard Analysis, and Preventive Controls for Human Foods regulations.[ix] This extensive set of regulation sets out a series of obligations to establish and follow risk based controls. Those involved with processing produce should be intimately familiar with these concepts, such as:

• CGMPs. FDA requires baseline sanitation, personnel hygiene, equipment design, and facility maintenance for food facilities.[x]
• Hazard Analysis and Risk-Based Preventive Controls. FDA also requires food processors to develop and implement written food safety plans that include a hazard analysis identifying known or reasonably foreseeable biological (such as listeria bacteria), chemical, and physical hazards, and then design and follow procedures aimed at preventing those hazards.[xi] Thus, produce processors, such as those freezing blueberries, must consider risks that a product may be contaminated with listeria and have measures that significantly minimized or prevent such risks.
• Supply-Chain Program. Food processors may rely on certificates of analysis or other verification techniques provided by suppliers, but they still must ensure that the suppliers are qualified to provide such assurances. In the context of frozen produce, this means the processing facility may need to audit upstream growers to verify that they are implementing appropriate controls to prevent pathogen contamination. [xii]

Risks of Non-Compliance

Failure to comply with these requirements exposes growers and food manufacturers to significant legal and regulatory consequences, including civil and criminal charges.[xiii] FDA has a range of enforcement tools available, including warning letters, import alerts, mandatory food recalls, and may seek injunctions to prevent further operations at a facility. In serious cases, FDA may refer matters to the U.S. Department of Justice for criminal prosecution, which can result in fines and imprisonment. It was not long ago that corporate officers of the Peanut Corporation of America were sentenced to decades in prison for their involvement in a salmonella outbreak that sickened 714 people, killed nine, and triggered one of the most wide-spread food recalls in American history.[xiv]

Firms that have been subject to recalls may find themselves facing more frequent inspections and closer examination of their food safety systems. A pattern of non-compliance, or inadequate response to a recall event, could escalate to more serious enforcement actions. In contrast, firms that can demonstrate robust food safety plans, thorough recordkeeping, and prompt corrective actions may be better positioned to manage regulatory engagement following a recall. 

Beyond regulatory liability, non-compliance can result in severe operational and reputational harm resulting from a foodborne outbreak. Product recalls and personal injury lawsuits are costly and may cause contractual liabilities, loss of customer relationships, and damage to brand reputation that can take years to repair.

Conclusion

The frozen blueberry recall is a timely reminder that food safety is a shared responsibility across the supply chain. Companies in the produce and processed food sectors should treat this recall as an opportunity to assess their compliance posture, ensure their food safety plans are current and effectively implemented, and confirm that personnel are properly trained. Proactive investment in food safety compliance is far less costly than responding to a contamination event, recall, or enforcement action. 

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