Export Compliance Daily is a Warren News publication.

Critical Testing and Training Begins for Brokers Following Release of FDA Guide for ACE Implementation

Some five months out from the Nov. 1 deadline for cargo release in the Automated Commercial Environment, filers and software developers are shifting into overdrive to implement Partner Government Agency (PGA) message set requirements, said customs brokers and programmers in interviews. Given the large volume of imports regulated by the Food and Drug Administration, that agency’s release of its final Supplemental Guide on May 12 marks an important step, followed closely by the draft release of CBP’s ACE Business Rules implementation guide three days later.

The trade community and government agencies hope to avoid a repeat of Australia’s disastrous rollout of its own customs IT system in 2005, which saw trade grind to a halt as cargo piled up at ports awaiting clearance. Filers and software developers were given only three months to develop and test, resulting in weeks of rejected entries and data privacy issues, according to a post-mortem commissioned by the Australian Customs Service (here).

CBP took the episode to heart, switching from plans for a one-time release of ACE to a series of major releases, and eventually its “Agile” approach of modular releases. That approach will be tested over the next few months as November 1 approaches, said Ken Bargteil, a customs broker who sits on the Trade Support Network and chairs the National Customs Brokers & Forwarders Association of America’s ACE Strategy Task Group. The staged release “has worked well up until now, but we’re looking at a compression of events, a convergence of functionality, all being delivered toward the end of this timeframe,” said Bargteil. “Right now, we’re in May. We’re just getting some of these requirements. There isn’t a whole lot of wriggle room.”

The final release of FDA’s Supplemental Guide (here) allows the process of coding, testing and training to begin in earnest for software developers and filers of FDA-regulated entries. The document is the product of months of discussions within the FDA ACE/International Trade Data System working group, consisting of 65 importers, brokers and customs brokers and about 25 CBP and FDA officials, said participant Sandra Scott of SEKO Logistics. A single importer and one software developer have since been engaged in “end-to-end” testing to make sure it works before an FDA pilot begins in July (see 1503240065), she said.

Development of FDA’s PGA message set was complicated by the addition of new data requirements by the agency, said Celeste Catano of Kewill, a software developer. Even after narrowing them down in response to feedback from the ACE/ITDS working group, the number of data fields FDA requires for regular filing and prior notice will “at least double,” said Catano, also a working group participant. The agency is also setting different data requirements for each commodity, moving away from “one screen fits all” approach, she said. “It’s going to be a lot more complicated to piece out.”

Nonetheless, the new system will be “a lot better” in some respects, said Catano. Now that FDA has segregated its message set by type of commodity, users filing a particular commodity may only see fields required for that commodity, saving them the work of having to figure out which data elements are needed, she said. Compared to ACS, FDA’s ACE guidance documents “have a lot more rules and substance to them that give us better guidance as to when you need certain things,” said Catano. “We’ll all be able to make it a lot better.”

Catano expects all of Kewill’s FDA programming to be out by July, in time for the pilot. Other developers are taking a more piecemeal approach, putting out components as they are developed for each FDA-regulated commodity, such as food, drugs, medical device and biologics, she said. Although the pilot will have limited participation, FDA will open its ACE programming up to more filers before November so they can get experience ahead of the deadline. “They really have a compressed timeframe to do this,” said Catano. The “goal for most people” is to have everything ready so people can start to file “late summer,” she said. Given that such a big chunk of entries are FDA-regulated, the agency “really needs to get that going ahead of time,” said Catano.

In the meantime, customs brokers are working not only with software developers, but also internally and with importer clients to ensure they continue to get the right data in the correct format, said Cindy Allen, vice president of U.S. customs brokerage at DHL Global Forwarding. Before programming even begins, DHL is conducting a review of FDA’s supplemental guide with an eye to designing business processes. Only once those concepts are tested will its software developer begin coding, followed by testing, recoding, and retesting to implement any fixes or adjustments, said Allen, who headed CBP’s ACE Business Office until she moved to DHL in 2012. DHL is also allowing time for any changes that will have to be made if issues come up in the FDA ACE pilot, she said.

At the same time, DHL is in the process of going to its importer clients to inform them of new data elements and formatting that will be required by Nov. 1, said Allen. In many cases, those importers will in turn have to go back to where they get the data -- their suppliers -- to relay what they’ll need. Many large importers have an electronic data interchange system (EDI) feed from their suppliers, so that system will need to be redesigned, she said. Importers will then need to change their own programming to get data from their suppliers to DHL, and DHL will need to test that the feed from its importer works. Finally, DHL will need to test the end-to-end process to make sure the data is successfully making it from the supplier, to the importer, to DHL, to CBP and out to the PGAs, said Allen.

Given that FDA is one of many PGAs for which ACE filing will be required in November, the work involved in that process is no small feat. “We’re quite concerned at this point that we’re going to have enough time,” said Allen. “I’m going to have to do that 15 times between now and November,” she said. “We’re quite concerned about the resources that are going to be required to do all of that work, and do that for each one of our clients.” Even if the importer can get the data DHL requires for filing, any breakdown in the chain of automation could mean DHL employees have to manually key it in, requiring more resources and adding more costs for the client, said Allen.

There's some concern that CBP’s November deadline is too ambitious. “From a software development point of view, the current lead time for design, development and deployment of the bulk of the ACE Entry Summary and Cargo Release is now simply way too short,” said Uwe Sartori of Advanced Transportation Systems (ATS). Programming requirements for all PGAs should have been released in 2014, which would have allowed ATS to integrate its development into normal day-to-day development work, he said. Instead, ATS, a small company with a single programming team to bring its PGA message sets online, will be working "overtime from now through October” to meet the deadline, said Sartori. PGA programming, which ATS intends to start in June for a September release, will have to compete with completion of ACE Cargo Release deployment, he said.

“The trade really needs to speak up and have CBP rethink their deadline approach,” said Sartori. Borne out of a desire to turn off ACS so ACS maintenance dollars can be put into ACE development, there is nothing in the 2014 ITDS executive order that mandates the November deadline, he said. “As one who has been involved with CBP through the Trade Support Network since 2001, I can appreciate the shift from a glacial pace to a more robust one,” said Sartori. “However, the new ACE race pace is unrealistic. With the very late releases of CATAIR documentation, the November 1 deadline is going to be extremely challenging to meet,” he said.

Given the challenges, filers should be in communication with their software vendors to “make sure that they understand the exigencies of the situation,” said Bargteil. The developer will need to build in enough time for the filer to receive the software dates, incorporate them into its system, and have its employees properly trained and ready to begin on Nov. 1, he said. “Any prudent filer will try to be ready long before that to get some experience on the system,” said Bargteil. “To leave that until the last minute would be a very big mistake.”

According to Scott, filers shouldn’t leave testing of FDA requirements in ACE to the limited number of pilot participants. Importers or brokers that work with FDA, or any PGAs, need to be contacting those agencies to see about the possibility of testing, she said. “That’s going to be critical.”