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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. 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')."[4]

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.).[4]

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.).[4]


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.[4] 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.[4] 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[6][7], 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.[7] 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[4]:

  • 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[4]:

  • 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).

LAAF reporting and submissions requirements

Sections § 1.1152 and § 1.1153 of LAAF makes it clear a comprehensive package of analytical reports and other documentation is required for submission to the FDA after a LAAF-accredited analysis takes place at the lab. This includes test results, notifications, reports, studies, and required documentation, based off several scenarios. Broadly speaking, each component of the submitted package should include the name and physical address of the LAAF-accredited lab, an appropriate laboratory contact with email and phone number, and "an identification unique to the test results, report, notification, or study."[4]

The LAAF program places additional requirements on portions of the submission package. Regarding test results, the lab must include the name and street address of the test client (the owner or consignee) and any appropriate U.S. Customs and Border Protection entry and line numbers. As previously mentioned, sampling and analysis documents will also need to be submitted, including sampling plans, sample collection reports, sampler's qualifications, validation study details, verification study details, method modification and deviation justifications, and certification of the results, complete with name, title, and signature of the certifier. If any non-standard methods were used, the lab may also be asked to provide further details.[4]

For the actual full analytical report, which must be submitted with the above mentioned items, the lab must include[4]:

  • all components referenced in sections 7.8.2.1 and 7.8.3.1 of ISO/IEC 17025:2017
  • documentation of references for the analytical method used
  • name and signature of the analyst who completed each analytical, validation, and verification step, along with date
  • calculations made
  • additional references, in color where available, such as chromatograms, charts, graphs, photographs, etc.
  • complete identification of the reference standards used, addressing source and purity, while noting concentration, units used, preparation conditions, storage conditions, reference standard preparer, date of preparation, expiration date, chemical balance, solvent used, etc.
  • copies of labels from sample container used or any other labeling required as part of the evaluation process
  • all original raw data acquired during the course of the analysis
  • relevant supporting information such as storage location, instrument printout, and photocopies of original labels and documentation that came with the sample/product
  • identification of software used
  • associated certificates of analysis for standards and software
  • an information packet of qualifications for each analyst involved, including curriculum vitae, training records for the methods used, and other documentation demonstrating the analyst's ability to perform the method used

Finally, labs may qualify to submit abridged analytical reports rather than full analytical reports, particularly after they've managed to submit five error-free full analytical reports in a row and are in good standing with the FDA's LAAF program. In addition to the previously mentioned documentation that must be sent with test results, the abridged analytical report will only require the components referenced in sections 7.8.2.1 and 7.8.3.1 of ISO/IEC 17025:2017, as well as the quality control results, "including the expected result and whether it is acceptable."[4]

As of February 2022, it's not clear exactly how reports will need to be submitted. Section § 1.1110 states, "All applications, reports, notifications, and records submitted to FDA under this subpart must be submitted electronically and in English unless otherwise specified." Section § 1.1152 adds that "the results of all testing required to be conducted under this subpart directly to FDA via the location specified by the website described in § 1.1109, unless another location is specified by FDA."[4] Presumably details of the submission process will become clearer once sufficient laboratories are LAAF-accredited.

LAAF records requirements

The LAAF-accredited lab has a few additional records requirements placed on them. All "records created and received while [the laboratory] is LAAF-accredited that relate to compliance" with LAAF will need to be retained for five years after their date of creation. Such documents include:

  • accreditation, proficiency test, and comparison program results and related documentation;
  • documentation of food testing performed under LAAF;
  • all the components of FDA submission packets;
  • communications with the FDA and clients (owner or consignee) regarding food testing, including initial requests;
  • documentation of internal investigations, audits, and corrective actions related to LAAF testing;
  • documentation of suspension, probation, scope reduction, disqualification, or withdraw of LAAF accreditation

Additionally, those records must be accessible in a timely fashion for review and copying by the FDA. The rule also notes that they should be available "for electronic submission upon written request of an authorized officer or employee of FDA," noting if an electronic format is requested, the files should be submitted with 10 business days of request.[4] Finally, "significant amendments" to these records need to be tracked to their previous or original versions. This version control requirement means lab must retain all necessary versions, including the original. Any version control scheme should include the date of an amendment, the personnel responsible for the amendment, and a "conspicuous" notice on the original document indicating a change has been made and where to view that change.


What considerations should laboratory informatics software developers have with their solutions in regards to LAAF?

Whether a laboratory information management system (LIMS) or some other informatics solution, the laboratory informatics software developer can ensure its solution better meets the needs of a LAAF-accredited laboratory in several ways.

Sample acquisition


Analyses


Reporting

The informatics vendor will want to ensure or re-verify their solution's reporting module is able to address the needs of ISO/IEC 17025:2017. For reference, the report components addressed in sections 7.8.2.1 and 7.8.3.1 of ISO/IEC 17025:2017 include:

  • report title
  • name and address of the laboratory
  • location of activity performed (even at a mobile or third-party location)
  • unique identification or report components as being part of a complete report
  • clear identification of the end of the report
  • customer name and contact information
  • method used
  • unique identification, description, and condition of a sample and container
  • sampling date and reception date
  • dates of laboratory performance activities
  • date report is issued
  • reference to a sampling plan, methods, or other sources relevant to the validity and application of the results
  • statement of exclusive relation between the items tested, sampled, or calibrated and the actual results
  • results, with units of measurement
  • deviations from, additions to, or exclusions from the method
  • identification of the individual authorizing or finalizing the report
  • identification of results from external providers
  • specific test conditions (e.g., environmental conditions)
  • statement of conformity with requirements or specifications
  • measurement uncertainty presented in a same unit as or in a term relative to the measurand
  • opinions and interpretations of the results


Further reading


References

  1. 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. 
  2. 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. 
  3. "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. 4.00 4.01 4.02 4.03 4.04 4.05 4.06 4.07 4.08 4.09 4.10 4.11 4.12 4.13 4.14 "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. 
  5. "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. 
  6. Gust, J.C. (January 2004). "Developing a Proficiency Testing Plan for your Laboratory" (PDF). Measurement Science Conference 2004. https://www.nist.gov/system/files/documents/pml/wmd/labmetrology/dev-prof-test-gust.pdf. Retrieved 18 February 2022. 
  7. 7.0 7.1 Association of Public Health Laboratories (February 2018). "Proficiency Testing Due to Accreditation" (PDF). Laboratory Costs of ISO/IEC 17025 Accreditation: A 2017 Survey Report. pp. 10–11. https://www.aphl.org/aboutAPHL/publications/Documents/FS-2018Feb-ISO-IEC-Accreditation-Costs-Survey-Report.pdf. Retrieved 18 February 2022.