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FDA Proposes to Require Testing by Accredited Labs to Remove Food From Import Alert, Prove Admissibility

The Food and Drug Administration is proposing a new accreditation scheme for food testing laboratories that would require importers to use accredited laboratories in some circumstances, including getting food they import off import alerts and proving admissibility of food that is initially refused admission.

Required under the Food Safety Modernization Act, FDA’s proposed rule would create a framework for recognizing accreditation bodies, which would in turn accredit food testing laboratories. Results of food testing conducted by laboratories under the program would be required to be sent directly to FDA. Only labs accredited under FDA’s scheme would be able to conduct food testing in certain circumstances, such as when a food safety problem is identified or suspected, when FDA issues a food testing order, or to meet FDA-mandated testing requirements for sprouts, shell eggs and bottled drinking water.

Specifically for importers, use of accredited food testing labs would be mandated to support removal from an import alert through consecutive testing of the food at issue. FDA declined in the proposal to say how many consecutive tests would be sufficient to remove a food from an import alert, though it noted that standard practice is to submit evidence related to five non-violative shipments.

Accredited food testing labs would also have to be used to support admission of an article of food under Section 801 of the Federal Food, Drug and Cosmetic Act. Under that section, FDA may refuse admission of an imported food if it appears to be adulterated or misbranded, but the owner or consignee may subsequently provide evidence to the agency to convince it to admit the food.

The use of accredited laboratories by importers in these circumstances would replace the existing framework of private laboratories currently relied upon by importers. FDA says insufficiently clear standards for testing and sampling across FDA districts has contributed to a lack of consistency under the current system. The agency also says that the existing model has resulted in concerns over practices such as “testing into compliance,” where multiple samples from a shipment are tested but only those that would allow a shipment to enter are submitted to FDA.