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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. The rule 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')."

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.

Accreditation bodies and laboratories that have been or are seeking to be be recognized by the FDA as able to LAAF-accredit or be LAAF-accredited, respectively, are also affected by this rule. Accreditation bodies seeking to accredit labs to the LAAF rule must be able to demonstrate compliance with ISO/IEC 17011:2017 and the membership and signatory requirements of the International Laboratory Accreditation Cooperative (ILAC) and its Mutual Recognition Arrangement (MRA), as well as other obligations laid out by LAAF (e.g., conflict of interest requirements, laboratory assessment and corrective action requirements, records and reporting requirements, etc.).

For each method of food 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 with the last 12 month. 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.).

How does LAAF affect laboratories who are or want to become LAAF-accredited?

Broadly speaking, most competitive and well-established food and environmental testing laboratories will already be ISO/IEC 17025:2017 certified. However, those labs who are or want to be LAAF-accredited will need to ensure or re-verify that "each method of food testing for which it is or will be LAAF-accredited" meets the section seven method selection, verification, and validation requirements set out in ISO/IEC 17025:2017. LAAF also mandates proficiency testing for each of the lab's LAAF-intended methods, with the proficiency test needing to have occurred within the last 12 months and results needing to have been submitted to the FDA within 30 calendar days of receipt. Most accreditation bodies that certify a lab to ISO/IEC 17025:2017 either make strong recommendations for or requirements of proficiency testing once or twice a year, but not all labs interested in LAAF accreditation may participate in proficiency testing. Non-certified labs interested in food safety testing will have to weigh the costs of ISO/IEC 17025:2017 accreditation and any proficiency testing associated with it against the LAAF-mandated circumstances of testing and how common they will be, as the costs are typically not trivial. This process may be more challenging for those labs with non-standard methods that don't readily fall under an existing proficiency testing program, requiring a comparable and approved comparison program.

The lab will also need to take into consideration sampling, analysis, and reporting requirements.

LAAF sampling requirements

The lab will also need to capture and submit the necessary LAAF-specified sample information with results reporting, including the:

• sampler's qualifications (first time only; reference previously submitted qualifications in subsequent submissions);
• documented sampling plan, including name of the sampler and sampling firm;
• sample collection reports for each sample, including product code, sample environment, date of sampling, lot number, sample size, sample identity, sample quantity, sample collection procedures and preparations, chain of custody, and methods used to ensure validity of analysis; and
• in the case of FDA-determined variances or deviations from sampling plans and documentation, advanced notice of sampling ("48 hours before each of the next 10 occasions") with unique identification and necessary identifying, demographic, explanatory, and chronology information.

LAAF analysis requirements

For analyses, the LAAF-accredited lab will also be required to ensure the:

• analyses are conducted solely on the sample or representative sample received from the sampling firm;
• analyst is qualified to conduct the analysis on the sample, including having demonstrable experience with the LAAF-accredited test method, and complies with conflict of interest requirements (i.e., no gifts, gratuity, or other items of value in receipt for the analysis);
• appropriate LAAF-accredited test method (the method must be properly verified) or FDA-approved method outside the scope of LAAF-accreditation associated with the sample is used; and
• testing process and results are documented "to account for all information that is required to be included in a full analytical report" (see the next section).

Further reading

• Association of Public Health Laboratories (February 2018). "Laboratory Costs of ISO/IEC 17025 Accreditation: A 2017 Survey Report" (PDF). pp. 16. https://www.aphl.org/aboutAPHL/publications/Documents/FS-2018Feb-ISO-IEC-Accreditation-Costs-Survey-Report.pdf.