Laboratory Accreditation for Analyses of Foods, Final Regulatory Impact Analysis

The rule will require that testing of food in certain circumstances be performed by a participating laboratory (participating lab) accredited to the new standards established by the rule by a recognized accreditation body (participating AB), and for the test results to be submitted to us. The costs of the rule will primarily be incurred by participating ABs, participating labs, shell egg producers, sprouts producers, bottled drinking water manufacturers, owners and consignees of import related food, and us. In rare circumstances, firms will have participating labs conduct tests for several reasons including for evidence to be removed from an order suspending registration, prior to issuance of a mandatory recall, for an appeal of an administrative detention order, and under a Directed Food Laboratory Order. We will incur costs to establish and maintain the program for recognizing ABs that apply to participate in our program, evaluating participating ABs and reviewing the performance of participating labs, and for reviewing associated documents and reports.

The benefits of the rule include a reduction in the number of foodborne illnesses from fewer false negative test results for covered import related food and for covered tests of shell eggs, sprouts, and bottled drinking water. We anticipate cost savings from clarifications of the process for compiling, submitting, and reviewing analytical reports for covered import related food, including a reduced reporting burden. There will be less revenue lost from fewer false positive test results for covered import related food and for covered tests of shell eggs, sprouts, and bottled drinking water and other food.

Regulatory Impact Analysis

Laboratory Accreditation for Analyses of Foods (PDF 1.04MB)

Docket: FDA-2019-N-3325