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Title: What do Laboratory Accreditation for Analyses of Foods (LAAF) labs require out of a LIMS?

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: December 2023

Food and beverage labs and the LAAF program

The Food Safety Modernization ACT (FSMA) 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." The FSMA was amended in December 2021 to include the Laboratory Accreditation for Analyses of Foods (LAAF) rule, mandating that "testing of food in certain circumstances" be performed by LAAF-accredited laboratories, as part of the overarching goals of the FSMA. (However, the FDA notes that these testing scenarios represent "certain tests that are already occurring" in the food industry and aren't new.) The FDA emphasizes that testing of food includes "the analysis of human or animal food, as well as testing of the food growing or manufacturing environment (i.e., 'environmental testing')."

The "certain circumstances" of LAAF-mandated 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.

For each method of food and beverage testing that is or will be LAAF-accredited, laboratories seeking LAAF accreditation must be able to demonstrate compliance with ISO/IEC 17025:2017 and show that each method has also successfully passed a proficiency test or comparable program within the last 12 months. It must also show that it uses appropriate reference materials or quality control samples for each sample batch tested under the LAAF rule. Of course, the lab must also comply with other obligations laid out by LAAF (e.g., conflict of interest requirements, documentation of qualifications and conformance, analytical requirements, records and reporting requirements, etc., addressed in the next section).

LAAF accreditation is voluntary, and labs from both the United States and outside the U.S. are able to participate in the LAAF program. As of the beginning of December 2023, there are 24 accredited laboratories and seven accreditation bodies. The number of accredited labs is expected to grow (though the list of "certain circumstances" is limited, in turn likely limiting the number of labs finding it worth accrediting to the LAAF program), as the LAAF program won't come into effect until well after "there is sufficient LAAF-accredited laboratory capacity for the food testing covered by the final rule." That capacity number isn't known, but as more labs become LAAF-accredited, they will increasingly wish to ensure their informatics systems (e.g., laboratory information management systems [LIMS]) can not only help them continue to meet ISO/IEC 17025 requirements (which are referenced in LAAF and likely already in place for most high-level food and beverage labs) but also the additional requirements placed on the lab by the LAAF program itself.

LIMS requirements for labs accredited to LAAF

A food and beverage laboratory accredited to ISO/IEC 17025 is already likely to use a LIMS within their operations. That LIMS ideally addresses numerous standard user requirements for ISO/IEC 17025-accredited food and beverage labs, including tools for the provision of preloaded and configurable sample types and analytical test methods of the food and beverage industry; the management of documents, images, and attachments, with versioning and release controls; development of regulatory-driven safety plans, including building HACCP steps into laboratory workflows; and improvement of reaction time to non-conformances, including automatically messaging suppliers and re-prioritizing or pausing related activities. (For more on this, see How can a LIMS assist food and beverage industry compliance with ISO 22000 and ISO/IEC 17025?.)