Gary Ryan - Comment

The FDA is amending its prior notice requirement to require an additional data element showing whether "the article" has been refused entry in any country. First of all, "the article" is not specific enough. Does "the article" refer only to the specific shipment to be covered by the prior notice or does it apply to the same type of merchandise from the same manufacturer or shipper that was refused customs entry? Shouldn't the refusal be more specific? If the shipment was refused customs entry because it arrived on non-complaint wooden pallets, was returned to the shipper, the shipment reloaded on compliant pallets, it appears the shipment would have to be reported; however, not because the product itself was refused entry. In most cases the prior notice is filed by the importer, or its agent. The importer may be totally unaware, and the shipper will not tell them, whether a shipment was rejected elsewhere. Holding the importer liable for what is found later to be a false decalaration does not seem reasonable.