CBP Sets 'Tight' June 15 Deadline for FDA Entries and Entry Summaries

CBP’s June 15 mandatory use date for filing electronic entries and entry summaries in ACE is tight, leaving little time to implement the latest FDA changes to its ACE programming and smooth out remaining issues, said customs brokers and software developers shortly after the agency announced the deadline. As detailed in a Federal Register notice (here), CBP will as of June 15 require filing in ACE of FDA entries and entry summaries under entry types 01, 03, 06, 11, 23, 51 and 52, the Automated Commercial System “will no longer be a CBP-authorized [electronic system] for purposes of processing these electronic filings,” said the agency. Though CBP said it will monitor implementation, CBP should ease in enforcement to give the trade community time to adjust, said one broker.

For now, the legacy ACS will remain the electronic system for FDA-regulated entries and entry summaries of entry types 02, 07, 08, 09, 12, 21, 22, 31, 32, 34, 38, 41, 42, 43, 44, 45, 46, 61, 62, 63, 69 and 70, said CBP’s notice. CBP has yet to announce a mandatory date for entries subject to quota, though it has indicated it plans to begin using ACE for quota in July (see 1603160037).

The deadline leaves little more than a month for the trade community to get ready for full filing in ACE, and comes shortly after deployment of several changes to FDA’s PGA message set included in the most recent version of the agency’s supplemental guide (see 1604200042). That’s too close for comfort for some. “Too soon!” said Amy Magnus of A.N. Deringer. “The deadline is tight,” said Celeste Catano of Kewill.

CBP will deploy those PGA message set changes into the live ACE system on May 31, “which gives the trade just 15 days to verify that everything is working correctly,” said Catano. Some of the changes are not compatible with current versions of FDA programming, said Fany Flores-Pastor of Descartes System Group. “This is not good,” she said. “We are discussing with CBP to see if they can make it backward compatible for at least a month or so, and allow the trade to update their systems accordingly. I really hope CBP will allow this and not risk the June 15 deadline,” said Flores-Pastor.

Nonetheless, initial reaction to the deadline "wasn't bad at all" when CBP informed Trade Support Network leadership on a call earlier this week, given recent high rates of ACE filing for FDA, Flores-Pastor said. “I believe that the trade has been waiting for CBP to provide a deadline for FDA so brokers can finally get their importers to give the new information needed to file ACE entries with FDA,” said Flores-Pastor. Some importers have not been as eager to cooperate given that there were not deadlines, she said. Flores-Pastor said trade readiness as at a point where she doesn’t “anticipate a big impact to the trade,” though a month of lead time is “probably not” enough for everybody. The Customs Commercial Operations Advisory Committee (COAC) urged CBP to announce its FDA ACE deadline in a recommendation adopted at its April 27 meeting (see 1604270050).

Given current issues related to FDA entries and the overall ACE system, CBP and FDA should allow the trade community some leeway after the deadline, said Cindy Allen of Trade Force Multiplier. “I think that there are still some significant challenges with the messaging for FDA entries between the two agencies systems: ACE release and FDA's Predict system,” she said. “I hope that both CBP and FDA take a soft approach in implementation and that enforcement is not going to be a hard line stance,” Allen said. “There are also known issues within ACE between ACE Release and the Truck Manifest module. Given the volume of FDA goods at the Northern and Southern border, this will add another layer of complexity in determining causes of missed releases and confused FDA messages. In the next month it's my hope that the CBP development team will focus on resolving the PGA messaging issues that currently exist to facilitate the deadline,” said Allen.