Do FDA rules discriminate against imports?

12/21/2011 07:04:00 AM
Tom Karst

 Do FDA rules discriminate against imports?

The Fresh Produce Association of the Americas submittted a thoughtful comment to the FDA on the issue of  "Food Safety Modernization Act: Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012."

Here is a point made in the document that contends proposed re-inspection fees constitute a trade barrier. From the FPAA and Lance Jungmeyer:

Furthermore, the proposed “import fees” fees for removal from “Detention Without Physical Examination/DWPE” may be viewed as trade barriers because they are not fees that are also assessed on domestic products. For imported produce, when a positive sample occurs, the product is put on DWPE (product removed from market and no longer allowed to be imported) and is not removed until there is a petition and a process, including “5 clean samples.” Under FSMA, FDA is proposing to charge $224/hour for the work of removal from DWPE, which will cost importers (or whatever entity requests the removal) potentially tens of thousands of dollars. 

In contrast, when domestic producer experience a positive sample, there is a recall. FDA charges a fee only when the producer does not cooperate with a  mandatory recall. For the same situation of a positive sample, the imported product is subject to significant fees while the domestic product is subject to minimal or no fees. Accordingly, a core principle of the World Trade Organization is “national treatment.” Member countries of the WTO cannot discriminate between imported and domestic products in terms of regulatory burden and/or fees.  

An additional factor is that for the “domestic and foreign facility re-inspection fees,” the differential between the domestic rate of $224/hour and the foreign rate of $325 / hour does not reflect the actual scope of costs incurred. To the extent that this differential is justified by the difference in travel time, the rate needs to be a sliding scale or country by country based on distance/time. Mexico and Canada, our largest food trading partners, are within a reasonable distance and should have a rate closer to that of the domestic rate than to that of faraway countries such as those in Asia.

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