An Interview with FSVP Agent, Brigitte Lehat
When it comes to importing food safely into the United States, understanding the FDA’s approach to hazard identification is key. We sat down with Brigitte Lehat, an FSVP (Foreign Supplier Verification Program) agent at Ken Lehat & Associates (KLA), to discuss how the FDA classifies hazards, how suppliers manage contamination risks, and what documentation importers need to stay compliant.
The Three Main Hazard Categories
Interviewer:
Thank you for your time today, Brigitte. Let’s start with the basics. What are the three process-step hazard categories that the FDA recognizes in the manufacturing process?
Brigitte:
The FDA recognizes three main hazard categories: chemical, biological, and physical.
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Chemical hazards include contaminants such as pesticide residues, which should not be present in food. Under the Produce Safety Rule, suppliers using pesticides must stop applying them well before harvest, often weeks in advance. They then send their products to a third-party lab for testing and obtain a Certificate of Analysis (COA) to confirm the food meets pesticide safety limits. Independent verification is essential; it can’t just be done internally.
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Biological hazards include Salmonella, E. coli, and other microorganisms that can cause illness.
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Physical hazards occur when materials like metal fragments or broken glass accidentally enter food during processing.
Understanding Maximum Residue Level (MRL)
Interviewer:
Most food products have some level of contamination risk, whether from pesticides, microbes, or other residues. How do foreign suppliers control for these risks?
Brigitte:
Third-party labs analyze the products and report whether pesticides are “not detected” or “detected below the MRL” (Maximum Residue Level). Ideally, nothing should be detected. But if traces are found, they must be below the MRL, which represents the maximum level considered safe for human consumption.
Interviewer:
What does “maximum residue level” really mean? Does it guarantee that no one will ever get sick, or does it just mean the risk is extremely low?
Brigitte:
It means the level is so low that it’s not considered dangerous to the public. These thresholds are established by the FDA and international bodies such as the United Nations and Codex Alimentarius.
There’s never zero risk, but it’s statistically insignificant. Maybe one in a million people could be affected. The risk is so minimal that it’s not regarded as a public health concern.
Interviewer:
And what about biological hazards? Do they work the same way?
Brigitte:
No. Biological hazards are treated differently. There’s no acceptable level for pathogens like E. coli or Salmonella. Any detection is considered unacceptable and requires corrective action.
Controlling Hazards
Interviewer:
How do you determine which biological, chemical, and physical hazards are likely enough to require controls in a food’s hazard analysis?
Brigitte:
It depends on the specific type of food. For example, eggs have a higher risk of Salmonella, so strict controls are required no matter how good the facility is. The FDA enforces regulations such as the Egg Products Inspection Act (EPIA) and the Pasteurized Milk Ordinance (PMO) for dairy. These rules exist because certain hazards are inherently more likely in those foods.
Hazard analysis must be done on a per-product basis. Each food has its own risk profile. Even within a single process, new risks can arise. Salmonella, for instance, might appear later in production even if earlier samples tested clean.
Balancing Supplier and Importer Responsibilities
Interviewer:
How should importers balance relying on a supplier’s hazard analysis versus doing their own independent assessment?
Brigitte:
Importers should never rely solely on supplier claims. They need independent verification, such as third-party lab tests and up-to-date Certificates of Analysis.
For ready-to-eat products, importers should also test shipments upon arrival. The FDA routinely tests products at ports and monitors country-specific risks. If a country has an outbreak, the FDA increases testing for similar imports
Documentation and Verification Expectations
Interviewer:
What level of documentation does the FDA expect in a hazard analysis to show that all foreseeable hazards have been identified and evaluated?
Brigitte:
The FDA expects verified documentation. It’s not enough to list hazards and controls in a plan; there must be proof that controls are implemented and verified for each shipment.
When I review plans, I always ask companies to show their logs and verification records. They need evidence that they’re actively monitoring and confirming that their controls are working as intended.
About Brigitte Lehat
Brigitte Lehat is an FSVP agent with certifications from CalAgX (2010), HACCP Certification (2017), FSPCA Certificates for Human and Animal Food (2017) and Product Rule Certification (2017 & 2025). She started her trading career in the food and beverage sector founding Art De Vivre Co., importing French wine between 1983 and 1988. With certifications in export training and U.S. food-safety regulations, she combines academic rigor, on-the-ground sourcing, and cross-cultural trade skills to facilitate hassle-free U.S. product entry. She is an FSVP agent for Ken Lehat & Associates (KLA).