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==Food and beverage labs and the LAAF program== | ==Food and beverage labs and the LAAF program== | ||
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<ref name="FDAFoodBill10Arch" /> 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."<ref name="HamburgFood11Arch">{{cite web |url=http://www.foodsafety.gov/news/fsma.html |archiveurl=https://web.archive.org/web/20110107124402/http://www.foodsafety.gov/news/fsma.html |title=Food Safety Modernization Act: Putting the Focus on Prevention |author=Hamburg, M.A. |work=FoodSafety.gov |date=January 2011 |archivedate=07 January 2011 |accessdate=06 December 2023}}</ref> 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<ref name="FDALabAccred21">{{cite web |url=https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/laboratory-accreditation-analyses-foods-final-regulatory-impact-analysis |title=Laboratory Accreditation for Analyses of Foods, Final Regulatory Impact Analysis |publisher=U.S. Food and Drug Administration |date=03 December 2021 |accessdate=06 December 2023}}</ref>, 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.<ref name="FRLab21">{{cite web |url=https://www.federalregister.gov/documents/2021/12/03/2021-25716/laboratory-accreditation-for-analyses-of-foods |title=Laboratory Accreditation for Analyses of Foods |author=U.S. Food and Drug Administration, Health and Human Services Department |work=Federal Register |date=03 December 2021 |accessdate=06 December 2023}}</ref>) 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')."<ref name="FRLab21" /> | |||
Labs from both the United States and outside the U.S. are able to participate in the LAAF program.<ref name="KlemmLab23">{{cite web |url=Laboratory Requirements for the FDA LAAF Accreditation Program |author=Klemm, K. |work=ANSI Blog |date=26 April 2023 |accessdate=06 December 2023}}</ref> As of the beginning of December 2023, there are 24 accredited laboratories and seven accreditation bodies.<ref name="FDALAAFDash23">{{cite web |url=https://datadashboard.fda.gov/ora/fd/laaf.htm |title=Laboratory Accreditation for Analyses of Foods Program |work=FSMA Data Dashboard |publisher=U.S. Food and Drug Administration |date=2023 |accessdate=06 December 2023}}</ref> | |||
Labs from both the United States and outside the U.S. are able to participate in the LAAF program.<ref name="KlemmLab23">{{cite web |url=https://blog.ansi.org/anab/laboratory-requirements-fda-laaf-accreditation/ |title=Laboratory Requirements for the FDA LAAF Accreditation Program |author=Klemm, K. |work=ANSI Blog |date=26 April 2023 |accessdate=06 December 2023}}</ref> As of the beginning of December 2023, there are 24 accredited laboratories and seven accreditation bodies.<ref name="FDALAAFDash23">{{cite web |url=https://datadashboard.fda.gov/ora/fd/laaf.htm |title=Laboratory Accreditation for Analyses of Foods Program |work=FSMA Data Dashboard |publisher=U.S. Food and Drug Administration |date=2023 |accessdate=06 December 2023}}</ref> The number of accredited labs is expected to grow, 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."<ref name="FDALabAccLAAF23">{{cite web |url=https://www.fda.gov/food/food-safety-modernization-act-fsma/laboratory-accreditation-analyses-foods-laaf-program-final-rule |title=Laboratory Accreditation for Analyses of Foods (LAAF) Program & Final Rule - Frequently Asked Questions |publisher=U.S. Food and Drug Administration |date=26 October 2023 |accessdate=06 December 2023}}</ref> That capacity number isn't known, but as more labs become LAAF-accredited, they will increasingly wish to ensure their informatics systems can not only help them continue to meet ISO/IEC 17025 requirements but also the additional requirements placed on the lab by LAAF. | |||
==LIMS requirements for labs accredited to LAAF== | ==LIMS requirements for labs accredited to LAAF== | ||
Revision as of 20:38, 6 December 2023
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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
Introduction
Food and beverage labs and the LAAF program
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[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] 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[3], 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.[4]) 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')."[4]
Labs from both the United States and outside the U.S. are able to participate in the LAAF program.[5] As of the beginning of December 2023, there are 24 accredited laboratories and seven accreditation bodies.[6] The number of accredited labs is expected to grow, 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."[7] That capacity number isn't known, but as more labs become LAAF-accredited, they will increasingly wish to ensure their informatics systems can not only help them continue to meet ISO/IEC 17025 requirements but also the additional requirements placed on the lab by LAAF.
LIMS requirements for labs accredited to LAAF
Conclusion
References
- ↑ Cite error: Invalid
<ref>tag; no text was provided for refs namedFDAFoodBill10Arch - ↑ 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 06 December 2023.
- ↑ "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 06 December 2023.
- ↑ 4.0 4.1 U.S. Food and Drug Administration, Health and Human Services Department (3 December 2021). "Laboratory Accreditation for Analyses of Foods". Federal Register. https://www.federalregister.gov/documents/2021/12/03/2021-25716/laboratory-accreditation-for-analyses-of-foods. Retrieved 06 December 2023.
- ↑ Klemm, K. (26 April 2023). "Laboratory Requirements for the FDA LAAF Accreditation Program". ANSI Blog. https://blog.ansi.org/anab/laboratory-requirements-fda-laaf-accreditation/. Retrieved 06 December 2023.
- ↑ "Laboratory Accreditation for Analyses of Foods Program". FSMA Data Dashboard. U.S. Food and Drug Administration. 2023. https://datadashboard.fda.gov/ora/fd/laaf.htm. Retrieved 06 December 2023.
- ↑ "Laboratory Accreditation for Analyses of Foods (LAAF) Program & Final Rule - Frequently Asked Questions". U.S. Food and Drug Administration. 26 October 2023. https://www.fda.gov/food/food-safety-modernization-act-fsma/laboratory-accreditation-analyses-foods-laaf-program-final-rule. Retrieved 06 December 2023.
