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The FDA Food Safety Modernization Act (FSMA) final rule on Laboratory Accreditation for Analyses of Foods (LAAF)

What is the Food Safety Modernization ACT (FSMA)?

The FSMA is U.S. legislation that was signed into law in January 2011, giving the U.S. Food and Drug Administration (FDA) broader authority to regulate how the country's food supply is grown, harvested, and processed. The FSMA gives the FDA additional powers towards the prevention of food-borne risks, the inspection of food-related facilities, the enforcement of compliance controls and violations, the response to food supply threats, and the imposition of stricter controls on imported goods. The FSMA was largely born out of "high-profile outbreaks related to various foods" in the 2000s and recognition that "a breakdown at any point on the farm-to-table spectrum can cause catastrophic harm to the health of consumers and great disruption and economic loss to the food industry."

What is the Laboratory Accreditation for Analyses of Foods (LAAF) rule?

The LAAF rule is an amendment to the FSMA, as originally required by FSMA's Section 202 (a), that mandates laboratory "testing of food in certain circumstances" (more specifically, "certain tests that are already occurring") be performed by LAAF-accredited laboratories, as part of the overarching goals of the FSMA. As currently written, "owners and consignees" of food products or environments subject to FSMA-driven food testing are directly affected. The "certain circumstances" of testing include when:

• growing, harvesting, packing, or holding environments for sprouts test positive for Listeria species or L. monocytogenes as part of normal mandated environmental testing;
• egg producers of 3,000 or more laying hens, who have have already mandated tests on molting and non-molting pullets and hens, reveal Salmonella enteritidis during environmental testing;
• bottled drinking water facilities reveal Escherichia coli in their approved product and operations water sources as part of mandated environmental testing;
• the FDA issues a directed food laboratory order to any owner or consignee, specifying a particular food product or environment be tested for an identified or suspected food safety problem;
• the FDA conducts evidence-based hearings prior to a mandatory food recall order;
• the FDA reviews the corrective action plan for a registered food facility ordered to be suspended;
• the FDA examines submitted evidence as part of an administrative detention appeal process;
• a food article (that has arrived to the U.S., or has had an FDA-approved representative sample submitted prior to arrival) is submitted for admission of import or being offered for import into the U.S., to better ensure that the food article meets or exceeds the applicable requirements; and
• a food article impacted by an import alert (that has arrived to the U.S., or has had an FDA-approved representative sample submitted prior to arrival) requires successful consecutive testing in order to be removed from the import alert.