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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[1] 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."[2]
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)[3], that mandates laboratory "testing of food in certain circumstances" (more specifically, "certain tests that are already occurring"[4]) be performed by LAAF-accredited laboratories[5], 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[4]:
- 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.).
References
- ↑ U.S. Food and Drug Administration (23 December 2010). "Food Bill Aims to Improve Safety". U.S. Food and Drug Administration. Archived from the original on 26 December 2010. https://web.archive.org/web/20101226031457/https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm237758.htm. Retrieved 18 February 2022.
- ↑ Hamburg, M.A. (January 2011). "Food Safety Modernization Act: Putting the Focus on Prevention". FoodSafety.gov. Archived from the original on 07 January 2011. https://web.archive.org/web/20110107124402/http://www.foodsafety.gov/news/fsma.html. Retrieved 18 February 2022.
- ↑ "Full Text of the Food Safety Modernization Act (FSMA)". U.S. Food and Drug Administration. 13 December 2017. Archived from the original on 01 July 2019. https://web.archive.org/web/20190701000423/https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma. Retrieved 18 February 2022.
- ↑ 4.0 4.1 "Laboratory Accreditation for Analyses of Foods". Federal Register. 3 December 2021. https://www.federalregister.gov/documents/2021/12/03/2021-25716/laboratory-accreditation-for-analyses-of-foods. Retrieved 18 February 2022.
- ↑ "Laboratory Accreditation for Analyses of Foods, Final Regulatory Impact Analysis". U.S. Food and Drug Administration. 3 December 2021. https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/laboratory-accreditation-analyses-foods-final-regulatory-impact-analysis. Retrieved 18 February 2022.
