Food Safety Is Not Documentation, but Culture – U.S. Correspondence by Jay Lee (164)

‘Food Safety Culture’: The FDA’s Smart Era Blueprint Built on Four Core Pillars

From Regulation-Centered to Organization-Centered—Attitudes and Behaviors as Key Factors

Korean Companies Vulnerable Due to Certification Focus… Active Executive Involvement Required

△ Jay Lee, CEO of J&B Food Consulting

For several years now, the U.S. Food and Drug Administration (FDA) has been announcing and implementing its New Era of Smarter Food Safety Blueprint, a vision for food safety in the smart era. This blueprint is built on four pillars: first, tech-enabled traceability; second, smarter prevention and response to food safety incidents; third, modernization of new business models and retail; and fourth, food safety culture.

Food safety culture has already been adopted and implemented within the BRC (British Retail Consortium) certification scheme. The intent is to move beyond food safety certifications that focus solely on document control and instead evaluate whether a company has a structural system that genuinely protects food safety. This shift acknowledges that even certification schemes and regulatory inspections can have blind spots.

In recent years, the FDA has clearly changed the direction of food safety regulation. Moving away from a traditional framework centered on documentation and records, the FDA now views food safety culture—namely, an organization’s attitudes and behaviors toward food safety—as a core element.

When consulting with Korean food companies, many proudly note that they hold HACCP certification and have established food safety plans aligned with U.S. FDA regulations. However, the FDA does not stop there. The questions it asks are far more fundamental.

Do employees understand why these processes must be followed?

Is there a structure that ensures issues are reported immediately when they arise?

Is senior management truly involved in food safety?

If a company cannot clearly answer these questions, then no matter how perfect the paperwork may be, the FDA will consider it to have a weak food safety culture.

One of the most dangerous organizational structures is treating food safety as solely the responsibility of the quality team. A common structural weakness among Korean companies is limiting food safety accountability to a specific department. The FDA’s Smarter Food Safety Blueprint explicitly requires active involvement from top management. Organizations where executives lack understanding of food safety, remain disconnected from operations, or intervene only during crises struggle to earn the FDA’s trust—regardless of how many certifications they hold.

Companies with weak food safety cultures tend to show common warning signs.

First, employees follow regulations without understanding the reasons behind them. Checklists are completed, but staff cannot explain why a particular process is important.

Second, there is a tendency to hide problems rather than disclose them. Minor foreign material findings or process deviations go unreported under the mindset of “not making a big issue.” The FDA does not see this as a simple mistake but as intentional concealment. In the U.S., voluntary recalls are common, and the FDA does not penalize companies for proactively recalling products.

Why are Korean exporters particularly vulnerable when it comes to food safety culture?

The reason is simple. Korea’s food safety system has long evolved around certifications and results. In contrast, the FDA focuses on processes, behaviors, and decision-making structures.

Going forward, FDA regulation will ask this fundamental question:

Is this a company capable of making the right decisions when problems arise?

Only when Korean food companies can confidently answer “yes” will they become truly sustainable exporters in the U.S. market.

Tags: #FoodSafety #FDA

Machine translated

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