Certified Group, the Melville, N.Y.-based food-safety testing company, has received FDA approval for its validated analytical method covering perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) in frozen clams — giving seafood importers a regulatory-grade testing pathway as PFAS scrutiny at U.S. ports intensifies. The method was developed under direct FDA guidance and is formally cleared for frozen clam matrices, with the laboratory reporting that expanded PFAS analysis is available across nearly all seafood substrates.
The approval arrives against a backdrop of mounting import enforcement. FDA Import Alert 99-48, which authorizes detention without physical examination for shipments flagged for chemical contamination, has increasingly been cited in PFAS-related holds on bivalves and finfish entering U.S. commerce. Importers facing detained shipments typically must furnish independent laboratory evidence of compliance before FDA will release cargo, making a validated, agency-approved method operationally critical. Certified Group did not disclose the number of detained shipments that triggered the method's development or the cost of the testing service.
PFAS — per- and polyfluoroalkyl substances, a class of thousands of synthetic compounds — have drawn intensifying regulatory attention across food categories. In seafood, wild-caught bivalves and freshwater species have shown elevated PFAS uptake in peer studies, and several state agencies have issued consumption advisories for recreationally harvested clams and mussels in industrial watersheds. The EPA finalized maximum contaminant levels for PFOA and PFOS in drinking water in 2024, and FDA has been expanding its analytical surveillance work across food matrices, including aquaculture-raised species and imported shellfish. Industry observers note that frozen clams — a high-volume import commodity from Asia and Europe — represent a logical first validation target given their documented PFAS exposure pathways and commercial significance.
For importers and brokers operating under FDA Form 482 notices or Import Alert detention orders, the availability of an FDA-approved method from an accredited third-party lab reduces the evidentiary risk in contesting a hold. Without a formally validated method, laboratories must apply ad hoc analytical approaches whose acceptability FDA can challenge. Certified Group's cleared protocol standardizes that process for clams and, the company indicates, can be extended to finfish, shrimp, and other shellfish on request.
The broader supply-chain implication is a likely acceleration of PFAS pre-shipment testing among importers sourcing from regions with documented industrial PFAS contamination. Processors and importers who have not yet incorporated PFAS screening into their supplier-qualification or traceability programs may face growing pressure from retail buyers and foodservice customers seeking documentation of clean supply chains. Certified Group did not provide a timeline for additional species-specific FDA method validations beyond frozen clams. This article was produced by Crabs Blue, part of the Food & Beverage Magazine network.
Written by Michael Politz, Author of Guide to Restaurant Success: The Proven Process for Starting Any Restaurant Business From Scratch to Success (ISBN: 978-1-119-66896-1), Founder of Food & Beverage Magazine, the leading online magazine and resource in the industry. Designer of the Bluetooth logo and recognized in Entrepreneur Magazine's "Top 40 Under 40" for founding American Wholesale Floral, Politz is also the Co-founder of the Proof Awards and the CPG Awards and a partner in numerous consumer brands across the food and beverage sector.