NCBFAA Calls on FDA to Keep ACE Data Elements Optional, Revise Key Definitions in Proposed Regs

Some of the data elements FDA is considering making mandatory have been optional for over 20 years, the NCBFAA said. “ACE should not cause a change [to] this policy,” it said. For some, like API and intended use code, the information may not be immediately available to the filer, or even to the importer, causing them to have to reach up the supply chain for the data. Currently, filers can say the data element is unknown, which may result in delays in getting a “may proceed” but also allows the entry to be filed immediately so CBP can process it and potentially release it to the importer’s premises while FDA reviews the shipment. This is especially important for modes of transport with short lead times, like air cargo and land borders, the NCBFAA said. Making some of these currently optional data elements mandatory could result in backlogs of cargo at the port, and storage and demurrage costs, it said.

Also problematic are FDA’s proposed definitions for “owner or consignee” and “filer,” the NCBFAA said. FDA is proposing to define “owner or consignee” as the “person eligible to make entry,” but that implicates several parties to a shipment, including the customs broker. Rather, FDA should follow its own lead in the Foreign Supplier Verification Program rule and define the “owner or consignee” as the person with a direct financial interest in the product that caused the product to be imported. The ACE filer under the proposed regulations is currently defined as the person who is authorized to submit the required data. However, “submission” of required data is the responsibility of the importer, which is often not the same as the filer, the NCBFAA said. The definition of “ACE filer” should be changed to reflect the role of the filer as the party that “transmits” the data, it said.

The NCBFAA welcomed FDA’s proposal to allow submission of the total value of the entire entry, rather than the value of each entry line. However, the current proposal would simultaneously require that the total value reflect the value on the invoice and also be no greater than the value declared to CBP. That would be impossible in many cases where the invoice value includes non-dutiable charges not declared to CBP, such as freight and brokerage, the NCBFAA said. FDA should keep its requirement that the value submitted to FDA is the same as on the invoice, but allow the FDA value to exceed the CBP value, it said. But because freight and other charges appearing on the invoice are not broken out at the line level, FDA should continue to allow submission of the total value of the entry so the filer doesn’t have to go through the burdensome task of prorating these charges, it said.

The trade group’s letter also called on FDA to make several other changes to its proposed rule. FDA should enhance its product code builder so filers are better able to meet the new mandatory produce code data element requirement, it said. FDA should also make optional a proposed mandatory data element for “detailed quantity descriptions for each layer of packaging (starting with the outermost/largest package to the innermost/smallest package),” which could create a lot of work for filers without much meaningful benefit for the agency. FDA should eliminate a data element requirement for the contact information of a party to the shipment, which duplicates the already mandatory data element for importer of record contact information, the NCBFAA said. The effective date of the final rule should be 60 days after publication, rather than 30, to give the trade community time to integrate any changes, it said. Comments on FDA’s proposed rule are due Aug. 30. The Association of America Exporters and Importers recently requested an extension of the comment period (see 1608160031).