FDA Seeing Continued Rapid Increase in ACE Filing

TUCSON, Ariz. -- Filing of Food and Drug Administration entries in the ACE continues its rapid rise, with the latest data from the agency showing a “high percentage” of filers using ACE and the number of entries filed in the system “drastically” increasing since January, said Dominic Veneziano, director of FDA’s Division of Import Operations, at the National Customs Brokers & Forwarders Association of America annual conference on April 19.

As of March 27, FDA had processed 162,142 entries, with 40,609 of that total being non-disclaimed entries covering 123.672 entry lines and 121,533 being disclaimed entries with a 291,627 lines. A total of 25,907 entries had been filed only in the week before the statistics were compiled. Some 1,067 filers are now filing FDA entries in ACE as of March 27, an increase of 41 from only one week earlier. As of early February, 24,000 entries from 500 filers had been filed in ACE (see 1602040022). Brokers and forwarders are “doing a tremendous job of getting on board,” Veneziano told the audience.

Though the agency has now become comfortable to end its ACE filing pilot on May 2 (See 1603300011), Veneziano still had no definitive answer on when ACE filing would become mandatory for ACE entries. “December 2016,” said Veneziano, referring to the overall administration deadline for full implementation of ACE. Unlike other PGAs, CBP has yet to provide even a soft target for FDA filing in ACE (see 1602080042). FDA will continue to monitor the increase in ACE filing, but for now it “[doesn’t] have an answer yet” as to when that filing will become mandatory,” said Veneziano.

Despite its progress, FDA is still working to work out several kinks in its ACE filing capability. FDA is looking into the current two-hour delay as data is transferred from CBP to FDA after initial validation, which could cause issues for truck shipments with short lead times. Customs brokers in the audience raised issues with current procedures for processing entries by line. Veneziano said the capability was put in place for the trade’s sake in order to increase efficiency by allowing for release of the rest of a shipment when a few lines are held. But one broker said the current system is “convoluted,” with piecemeal notifications of lines being release causing brokers difficulties in monitoring their shipments. Another in the audience said brokers are having to use a manual process to satisfy the requirement to prorate entered value by line. Veneziano said he’d take both issues back to FDA staff for resolution.

Meanwhile, FDA’s 24/7 ACE help desk is close to up and running. The agency has found a contractor to take calls and provide entry status upon request, and expects to bring the help desk online in “hopefully about a month,” said Veneziano. Also on the near horizon are guidance documents FDA is developing on the Foreign Supplier Verification Program and Voluntary Qualified Importer Program. One key desire of the trade community – the ability to modify FDA entries rather than cancel them if inside the agency’s “five-day” window – is farther out. Eventually, FDA will get its data from CBP ten days in advance, and give the trade community five days to correct it, said Veneziano. However, he doesn’t see that happening until fiscal year 2017, he said.