The Laboratory Accreditation for Analyses of Foods (LAAF) Program is an FDA program established under the Food Safety Modernization Act (FSMA) in 2022 to improve the accuracy and reliability of certain food testing through standardized accreditation requirements and increased regulatory oversight.
Under the LAAF program, the FDA recognizes accreditation bodies (ABs) that assess and accredit laboratories to specific LAAF requirements. In certain situations, food testing must be performed by a LAAF-accredited laboratory.
Many laboratories interested in LAAF are also involved in or accredited to the AOAC Guidelines and requirements. However, AOAC accreditation is not required to be eligible for the LAAF Program. Laboratories can pursue LAAF accreditation independently of the AOAC Program, provided they meet the applicable LAAF requirements.
Learn more about the AOAC Laboratory Accreditation Program here.
Eligibility Requirements
To become a LAAF-accredited laboratory, the organization must demonstrate it is capable of conducting each method of food testing for which it will be LAAF-accredited, and meet all the following requirements:
- Accreditation to ISO/IEC 17025:2017 for each method by a recognized AB
- Successfully pass proficiency testing (PT), provided by a competent provider within the last 12 months for each method on the desired scope
- Ensure its procedures for monitoring the validity of test results includes the use of reference materials (RM) or quality control samples with each batch it tests
- Comply with all additional requirements for LAAF-accredited laboratories under this subpart while LAAF-accredited
Impartiality and Conflict of Interest
Impartiality is essential to the integrity of food laboratory testing. Under 21 CFR § 1.1147, LAAF-accredited laboratories must meet specific impartiality and conflict-of-interest requirements in addition to the general requirements of ISO/IEC 17025:2017. A LAAF-accredited laboratory must ensure that employees, contractors, and agents that are involved in food testing:
- Do not accept money, gifts, gratuities or anything of value from owner or consignee of food being tested
- Do not charge testing fees and recover direct testing costs independently of the test results
- Do not allow financial relationships or incentives to influence or appear to influence the outcome of testing
- Identify risks to impartiality on an ongoing basis and systems to eliminate those risks
For LAAF-accredited laboratories, these requirements add another layer of confidence that test results are reliable and unbiased, helping to support regulatory trust, protect public health, and maintain confidence in the food testing process.
Proficiency Testing (PT)
For continued LAAF Accreditation, laboratories must have successful proficiency testing for each method on the LAAF accredited Scope of Accreditation within a 12-month period. This is required for as long as the laboratory remains accredited to the LAAF guidelines.
LAAF-accredited laboratories are required to send results of proficiency testing to their recognized AB within 30 calendar days of receipt, regardless of the outcome. These results can be submitted via email or using the A2LA’s F104 Proficiency Testing Data Submission Form to the point of contact. Additional requirements for proficiency testing can be found in A2LA’s R103 General Requirements: Proficiency Testing for ISO/IEC 17025 Laboratories.
If the LAAF-accredited laboratory determines there is no proficiency testing program available or practicable for a method, it may use a comparison program. The laboratory must request approval from the recognized AB regarding the determination prior to using a comparison program in lieu of an annual proficiency test. The laboratory is required to demonstrate competency through participation in the comparison program.
Method Validation and Verification
If a LAAF-accredited laboratory conducts food testing using a validated method (in accordance with the requirements of ISO/IEC 17025:2017 7.2.2) for a specific intended use, but the LAAF-accredited laboratory has not previously applied the method under this section, the LAAF-accredited laboratory must have verified it can properly perform the method for the specific intended use (21 CFR § 1.1151 METHODS OF ANALYSIS).
If a circumstance occurs where a LAAF-accredited laboratory needs to use a method outside of its scope, they may need to submit a written request to FDA requesting permission to do so. FDA may approve the request if both following conditions are satisfied:
- A new method or methodology has been developed and validated but no reasonably available laboratory has been LAAF-accredited to perform such method or methodology, and
- The use of such method is necessary to prevent, control, or mitigate a food emergency or foodborne illness outbreak.
The laboratories are not required to submit their validation or verification records before reporting results under the LAAF Program. However, submitting these records alongside a live entry may delay the review and acceptance of results while the FDA reviews the documentation; any identified issues may cause further delays. When records are required, laboratories must provide the FDA with the full validation or verification package, including all supporting raw data, such as chromatograms, LOD/LOQ data, and complete microbiological confirmation records. A summary alone is not acceptable unless the FDA has provided specific approval, as outlined in 21 CFR § 1.1153(a)(1). Additionally, all LAAF testing results must be submitted to the FDA, regardless of outcome, including negative or non-detect results.
Communication: Check the Dashboard
The FDA’s LAAF Program Dashboard is used to apply for the program and submit required results, reports, and studies to the FDA. The dashboard also provides a way to submit and view required import notifications and access program updates. Laboratories are responsible for ensuring their dashboard information is accurate and up to date, including testing capacities, contact information and scope of accreditation. The AB is responsible for providing the FDA with the laboratory information submitted during the accreditation process and ensuring it is entered into the system prior to or during the application process. The AB does not determine a laboratory’s acceptance into the FDA LAAF Program. The AB conducts the assessment on behalf of the FDA, while the FDA retains responsibility for program acceptance.
- The name and street address of the LAAF-accredited laboratory;
- A point of contact for the LAAF-accredited laboratory, including email and telephone number, whom FDA may contact with questions or comments;
- An identification unique to the test results, report, notification, or study
If a laboratory identifies any inaccuracies in submitted information, it must immediately notify the FDA and submit a corrected version in accordance with ISO/IEC 17025:2017, Section 7.8.8. Any opinions or interpretations included in submissions must meet Section 7.8.7, while statements of conformity to specifications or standards must meet Section 7.8.6. Laboratories should ensure all submissions are true, accurate, unambiguous and compliant before sending them to the FDA.
If food testing laboratories seeking LAAF have any questions pertaining to program requirements and eligibility, please contact FSMA Technical Assistance Network (TAN) and if there are questions pertaining to LAAF program application and implementation, please contact FDALAAFInquiry@fda.hhs.gov.
Learn more about A2LA’s Laboratory Accreditation for Analyses of Foods (LAAF) Program here, or request a free accreditation estimate today.