- Food Safety Modernization Act (FSMA)
- Lab Accreditation for Analyses of Foods Rule
FSMA: Laboratory Accreditation for Analyses of Foods (LAAF) Program Rule
The Laboratory Accreditation for Analyses Foods (LAAF) establishes guidelines for food testing in specific situations. It does so by improving the reliability and accuracy of testing through uniform standards and enhanced FDA oversight.
Specifically, it provides mechanisms for the FDA to remove or admit foods from import alerts or detained imported food designations. It also provides increased capacity for the FDA to address identified or potential food safety problems.
While the rule does not directly affect food and beverage industry members, it regulates their testing partners.
The FDA will enforce the rule once it achieves sufficient laboratory capacity, giving affected parties six months' notice. Implementation is ongoing. Currently, LAAF accreditation is only required for mycotoxin testing.
The Rule is part of FSMA, short for the Food Safety Modernization Act.
How the Rule achieves its goal
LAFF establishes guidelines for FDA recognition of accreditation bodies, which then certify qualifying laboratories. When the FDA issues a LAAF action, food industry members must use accredited laboratories, which test samples and submit results directly to the FDA.
The LAAF rule applies to a very limited scope of food testing and when the FDA issues a directed Food Laboratory Order.
Who must comply with the rule?
The LAAF rule directly governs laboratories and accreditation bodies. It impacts food industry members when the FDA requires testing for identified violations of the Federal Food, Drug & Cosmetics Act (FFDCA) or suspected safety problems.
Food and beverage industry
The FDA may require LAAF-accredited testing for “identified food safety problems” (an article of food is adulterated or otherwise violates the Food, Drugs & Cosmetics Act) or “suspected food safety problems” (the FDA has a basis in fact about a specific article of food or production facility).
Specific commodities subject to LAAF-approved testing are:
- Sprouts
- Shell eggs
- Bottled water
The LAAF rule also applies to imported foods
LAAF-accredited lab testing is required for industry members:
- Seeking removal from import alerts,
- Seeking admission of detained foods,
- Appealing detention orders,
- Addressing safety concerns under FDA regulations.
Laboratories and accreditation bodies
Accreditation bodies must be recognized by the FDA. They in turn can grant accreditation to laboratories who meet requirements. Requirements for laboratories include:
- ISO/IEC17025 accreditation
- Satisfying conflict-of-interest requirements
- Frequency and method of laboratory assessment
- Laboratory oversight
- Reporting and recordkeeping
- Any requirements mandated by the Recognized Accrediting Body
Non-compliance consequences for the food & beverage industry
Products under FDA Warning Letters, import alerts, or detention require inspection and corrective action,which may include LAAF-accredited laboratory testing. Non-compliance may result in an injunction preventing interstate distribution, with repeat violators facing higher risk. The FDA's most severe action is product seizure, including impoundment of items already in the market.
How to find an LAAF-accredited laboratory for food testing
LAAF-accredited laboratories can be found through the FDA's online registry or through recognized accreditation bodies. Laboratories vary in their approved testing scope.
FDA public registry
The FDA’s public registry lists approximately 50 LAFF-accredited laboratories across North America, in the United States, Mexico, and Canada including their locations, certifying bodies, testing scopes, and contact information.
Recognized Accreditation Body
Eight Recognized Accreditation Bodies currently certify LAAF laboratories. When searching their websites, specify 'Food Testing' or 'LAAF' to find relevant certifications:
- AIHA LAP, LLC, Falls Church, VA, USA
- American Association for Laboratory Accreditation (A2LA), Frederick, MD, USA
- ANSI National Accreditation Board (ANAB), Fort Wayne, IN, USA
- International Accreditation Service, Inc (IAS), Brea, CA, USA
- Jamaica National Agency for Accreditation, Kingston, JM
- Mexican Accreditation Entity, a.c., Mexico City, Mexico City, MX
- Perry Johnson Laboratory Accreditation, Inc., Troy, MI, USA
- Standards Council of Canada, Ottawa, Ontario, CA
How to verify if a laboratory is LAAF-accredited
Laboratory LAAF accreditation can be verified through either the FDA's public register or the certifying Recognized Accreditation Body.
Reason for the Rule
The FDA established LAAF in response to food import testing fraud documented in a 1998 Senate Committee hearing, where importers selectively submitted only passing test results (“testing into compliance”) or manipulated samples.
History
The LAAF was established as part of the Food Safety Modernization Act of 2011. As the FSMA addresses a wide range of food safety concerns, LAAF provides uniformity and establishes a high standard for food testing.
Timeline
- December 2021: The FDA issues its final rule establishing the LAAF program.
- February 2022: LAFF is officially adopted. Accreditation bodies begin applying to become recognized.
- July 2022: The FDA posts its registry of six Recognized Accredited Bodies.
- May 2024: The FDA announces sufficient laboratory resources for LAAF mycotoxin testing.
- December 2024: Importers and consignees of foods must begin using LAAD-accredited facilities for FDA-mandated mycotoxin testing.
In the news
(Updated February 2025)
- Those Subject to LAAF Program Must Now Use LAAF-Accredited Laboratory for Mycotoxins Testing (December 2024)