LII:FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors
Title: FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors
Author for citation: Shawn E. Douglas
License for content: Creative Commons Attribution-ShareAlike 4.0 International
Publication date: February 21, 2022
On January 4, 2011, the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) was signed into law, giving the FDA more powers to protect the U.S. food supply and the people who depend on it. The legislation initially indicated that a laboratory accreditation program would be developed within "two years after the date of enactment"; however, such a program wasn't finalized until December 2021. That program and associated rule, called the Laboratory Accreditation for Analyses of Foods (LAAF), was published in the Federal Register on December 3, 2021, effective February 1, 2022.
This brief article examines FSMA and the LAAF rule and how they affect laboratories that are and want to become LAAF-accredited. Additionally, the article examines what a laboratory informatics vendor may want to consider when updating their solutions to address the needs of a LAAF-accredited lab.
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" 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')."
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 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.).
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 method selection, verification, and validation requirements set out in section seven of 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 proficiency test 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 of compliance 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 LAAF's sampling, analysis, reporting, and record keeping requirements.
LAAF sampling requirements
The lab will need to capture and submit the necessary LAAF-specified sampling information along 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(s), 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 submission requirements
Sections § 1.1152 and § 1.1153 of LAAF make 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."
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.
For the actual full analytical report, which must be submitted with the above mentioned items, the lab must include:
- all components referenced in sections 18.104.22.168 and 22.214.171.124 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 in the analyses
- 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 sampling documentation that must be sent with test results, the abridged analytical report will only require the components referenced in sections 126.96.36.199 and 188.8.131.52 of ISO/IEC 17025:2017, as well as the quality control results, "including the expected result and whether it is acceptable."
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." 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; and
- 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. Finally, "significant amendments" to these records need to be tracked to their previous or original versions. This version control requirement means the 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 make 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. A quality solution should already address most of the following requirements, but the vendor may need to make a few minor adjustments to ensure better support for the LAAF-accredited lab.
Sample acquisition and client management
Product and/or sample registration should be able to accurately capture submitted information and product state. Assuming the product is submitted for sampling, this includes product identifier(s), lot number, shipping container, client name and street address, and observations about the status of the received product. Whether the lab samples the product or a third party does the sampling, reception should also include sampling time and date, sample size, sample identifier(s), sample quantity, sample collection procedures and preparations, and chain of custody. Some of these details may be captured as part of a client management module of the system, though most will be documented at registration. However, LAAF also requires additional sampling documentation to be captured and sent by the lab. Can the informatics solution attach qualifications documents to a client record? Can sampling plans, sample collection reports, and advance notice of sampling documentation be captured, stored, and linked to registered products or samples, scheduled analyses, or analytical reports? Can a received product and/or sample be designated as LAAF-related in the system?
As the LAAF rule notes, analyses can be either food-related or environmental in nature. As such, the informatics solution should be flexible enough to address the subtleties of these types of analyses and the sample matrices associated with them. The well-designed system will likely come preconfigured with multiple test types for food and environmental testing. However, the system will need to be configurable in its tests and workflow management to allow for the addition of new and customized tests and method-related workflows. This prompts a few questions. Can an existing or new test or workflow be flagged as being LAAF-specific and marked as validated for LAAF? Or is there some other means to ensure a LAAF-related sample can only be connected with a LAAF-accredited test method or workflow? Can a custom, FDA-approved method outside the scope of LAAF-accreditation be entered into the system and marked as being LAAF-useable? The system also should ensure an analyst assigned to a LAAF-specific product, sample, or test is qualified to conduct a LAAF analysis (which, by extension, means the system should be able to flag an analyst as LAAF-qualified). Finally, the entire analytical process that runs through the system should be capturing all the necessary details for what the FDA considers a "full analytical report" (see next section).
Reporting and information packet submission
A quality informatics system will capture information and data from reception to final archiving of results. The LAAF rule highlights the importance of ISO/IEC 17025:2017 and its demands for reporting results. While the informed vendor will already address those requirements in its solution, the vendor will still 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 184.108.40.206 and 220.127.116.11 of ISO/IEC 17025:2017 and required by the LAAF rule include:
- report title
- name and address of the laboratory
- location of activity performed (even at a mobile or third-party location)
- unique identification of 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
However, there's more that the rule requires a LAAF-accredited lab to report. These additional requirements can be met more readily with a reporting tool that allows for highly configurable reports. This would allow for elements such as U.S. Customs and Border Protection entry and line numbers, references to the analytical method used, name and signature of the analyst(s), calculations made, certificates of analysis, and the many other elements mentioned prior. (See the bullet points in the section on LAAF reporting and submissions requirements for more.) Given that LAAF-accredited labs, under certain conditions, are able to submit abridged analytical reports to the FDA, a configurable reporting module will allow the lab to select either a full or abridged analytical report based on their current FDA-approved status with LAAF.
Finally, the LAAF rule currently indicates electronic reporting of the full submission package, though details on how this is to be done are sparse as of February 2022. The FDA will likely update submission rules, which the vendor should be attentive to in case a special electronic submission type is mandated.
As mentioned prior, the LAAF rule imposes some records requirements on the laboratory, requiring document management, archiving, retention, and versioning tools to allow the lab to more readily meet those requirements. The LAAF-accredited lab will inevitably collect many documents as part of becoming accredited and enacting tests under the LAAF rule, beyond just test results. Does the system have the ability to manage multiple document formats? Is there sufficient secure storage? Can emails and other externally-generated documents be fed into and stored in the system? Given the five-year retention rule, the system should be flexible enough to handle retentions of that length, even if the documents and data are compressed and archived. It should be relatively painless to be able to retrieve all those records, in a timely fashion for regulatory purposes. Documents also need to be version-controlled should "significant amendments" need to be made. Can the system retain all version of a document or dataset? Does the versioning procedure include the date of a change and identify the personnel responsible for the change? Can a "conspicuous" notice be added to the original document indicating a change has been made and where to view that changed document?
The Laboratory Accreditation for Analyses of Foods or LAAF rule has been a long time coming, as part of a mandate set out in the FDA's Food Safety Modernization Act. The intent with LAAF appears to be the provision of an accreditation program for laboratories participating in the critical role of ensuring the safety of the U.S. food supply. LAAF provides additional structure to the labs wishing to fulfil that role, ensuring they do it accurately and effectively. LAAF accreditation will not impact all food and environmental labs in the U.S., only those that choose to take up the role. Once accrediting bodies set up their LAAF accreditation programs, labs can begin the accreditation process and soon after conduct analyses of samples that fall under the umbrella of LAAF testing. These labs will not only need to be accredited to ISO/IEC 17025:2017 but also follow a number of other procedures, including proficiency testing, a critical component of LAAF. Reporting will also be strict, at least initially, until the lab qualifies for abridged reporting.
Given the intricacies and costs of being LAAF-accredited, a LAAF-accredited lab will lean on their laboratory informatics solutions to help the lab stay compliant. Established and knowledgeable informatics vendors will already have functionality in place in their solutions—typically a LIMS—to address the requirements of ISO/IEC 17025:2017. However, they will also likely need to make a few tweaks to their solutions to address the needs of a LAAF-accredited lab. For example, tests and workflows will likely require a "flag" to indicate to users whether or not a test or workflow is LAAF-related. The reporting module will need to be robust and flexible, allowing for the automated and manual placement of required information into the reports and other documents required with LAAF. And fully-featured document management, document retention, and version control will also be critical. Ultimately, the solution will ideally assist the LAAF-accredited lab with the rigorous requirements of accreditation through its feature set.
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