Most food companies work hard to take the proactive precautions and practical steps required by the Food Safety Modernization Act (FSMA) and other applicable laws and regulations to ensure that the food products they produce, package, transport, store or sell are safe for consumers to eat. Some companies, however, continue to ignore or, at times, let their guard down regarding, the good practices those laws embody. Others fail to adequately oversee the practices of supply partners. As a result, despite unprecedented education about and devotion of resources to food safety since enactment of FSMA in 2011, mistakes continue to happen, recalls proliferate and consumers continue to unknowingly face adulterated and misbranded food products.
For unwary and wary food companies alike, cautionary tales abound. Valuable lessons can be learned from the mistakes, intentional and unintentional, of others. Those accounts warrant telling and repeating.
Consider, for example, the recent fate of Sullivan Harbor Farm. In a 15-page complaint filed in federal court, the U.S. Food and Drug Administration (FDA) alleged that its investigation of the seafood processing plant uncovered numerous food safety deficiencies, including the processor’s failure to:
1. Implement a Hazard Analysis and Critical Control Points (HACCP) plan with sufficient controls to prevent known food safety hazards
2. Verify that controls used were effective
3. Monitor the controls
4. Maintain records reflecting the controls
5. Take corrective actions when practices failed to prevent food-safety issues
6. Handle food and packaging and sanitize surfaces in a manner that protected against contamination
This was not the first time that FDA had cited Sullivan Harbor Farm for food safety-related lapses. As a result, FDA requested that the Court enjoin further operations until Sullivan Harbor Farms agreed to clean its facility, implement an adequate HACCP plan and comply with other applicable laws and regulations to the satisfaction of FDA. In a 22-page consent decree entered on February 12, 2016, Sullivan Harbor Farm agreed to entry of an extensive injunction that provides that its future operations are contingent on completion of a comprehensive food safety overhaul, including retention of independent experts to oversee development and implementation of a new HACCP plan and other food safety-related systems.
The acts of others outside the four walls of your facility can cause a food company similar harm. The horse meat scandal in Europe continues to serve as a stark reminder of that lesson. Although that incident did not cause a widespread foodborne illness epidemic, it did cause consumer outrage, much less cause many to question how this could happen. The incident was all the more puzzling because it ensnared several large companies with well-known brands and sophisticated food safety regimens.
The answer to the quandary appears straightforward. Companies within that food supply chain did not adequately evaluate or oversee their direct supply partners or the suppliers of their partners.
Implementation of meaningful controls over internal operations and external supply chains is not easy. But there is no choice but to devote the time and effort to do so. Companies no longer can fly under the radar of governmental scrutiny, hoping that their practices and those of their partners will not be tomorrow’s bad news.
Stated otherwise, under the new food safety regime, the buck stops with each food company. It therefore is important that food companies take heed of the lessons that Sullivan Harbor Farm, the horse meat scandal and many other food adulteration or misbranding occurrences provide. The take away? Understand the laws, regulations, practices and protocols that govern your food-related business. And do the opposite of Sullivan Harbor Farm and the others who cut corners.
With respect to internal operations, companies must continually engage in proactive, realistic and ongoing assessment and action, including:
• Identification and analysis of known or reasonably foreseeable hazards that may cause adulteration or misbranding of food products
• Implementation of science-based measures to prevent or minimize the likelihood of the hazards identified
• Oversight of preventive controls to make sure that they are being carried out
• Verification designed to make sure that preventative controls are effective and up-to-date with technological advancements
• Corrective actions procedures to correct both isolated production problems and more systemic flaws with the preventative control systems
• Protection against intentional adulteration or misbranding
• Record review and record-keeping and access protocols
• A recall protocol in the event a problem occurs despite the other control.
Of course, even a well-designed food safety regimen may be fail without adequate buy-in from top management and well-trained employees who are able to implement all aspects of the plan.
Managing external relations requires that a company employ similar rigor in an effort to assess and understand with whom it is dealing and form strong, transparent relationships that meet its need, including:
• Conducting due diligence in preparation for the supply relationship, including assessment of the laws, regulations and protocols to which a the potential supply partner is subject to make sure that they mesh with the company’s needs
• Negotiating thoughtful supply agreements with precise terms
• Overseeing supply partners, including audits as needed of partner operations
• Building sufficient flexibility into the relationship to allow for change where needed to meet food safety obligations or other needs
• Retaining broad termination rights should the supply relationship fail to meet the company’s food safety obligations or other needs
Could this—the fate of Sullivan Harbor Farm or the companies that sold horse meat to unsuspecting consumers—happen to you? Perhaps it is probable for the unwary or to the company who believes it can ignore or skirt the law. But for companies who take heed of the valuable lessons the food safety mishaps of others provide, such a troubling result is unlikely.
John T. Shapiro, Esq., is a partner and member of the Food Industry Team at Freeborn & Peters LLP (Chicago).