CBP, FDA To Allow Some Leniency for June 15 ACE Deadline Until ACS Offline

CBP and Food and Drug Administration officials outlined transition procedures for the June 15 ACE mandatory use date for most FDA cargo release and entry summary submissions, during a June 9 webinar conducted by the agencies and the National Customs Brokers & Forwarders Association of America. CBP will on June 15 begin rejecting ACE entries that are flagged for FDA but are not accompanied by partner government agency (PGA) data, a CBP official said. However, the legacy ACE remains online and available as a fallback until July 23, and CBP will handle ACS filers on a “case-by-case basis” until that date, sending error messages and reaching out to non-ACE filers to get them aboard, he said. As CBP has previously said (see 1605270002), the agency will shut off ACS on July 23 and filers will “no longer have the ACS alternative,” the official said.

FDA will have its 24/7 help desk online by the June 15 transition date, and is currently training its staff to “respond to any concerns that may come up during the transition,” said Jessica Aranda of FDA. CBP will soon send out a CSMS message announcing the phone number, she said. FDA’s A.J. Seaborn says he expects FDA will be more lenient when examining filers in audits covering the transition period. FDA is currently looking at revamping its entire filer evaluation process, Seaborn said. There’s an understanding that there “has to be flexibility and leniency in this transition period,” he said.

FDA is currently working on making its error messaging more precise and understandable so the filer better knows what to correct, though the work won’t be completed by the June 15 transition, Aranda said. Currently, messaging is “a bit general,” at times giving the wrong impression to the filer as to the location of the error. FDA also plans to automate the paper notices of action it sends out when the agency conducts additional review of a shipment, Seaborn said. A proposed rule the agency plans on publishing in the “near future” will allow FDA to send out electronic versions of the notice, “allowing more expeditious notification” to the filer, importer and consignee, he said. The notices, which will be sent through FDA’s Import Trade Auxiliary Communications System (ITACS), will be account-based so there’s no chance that entry information will wind up in the wrong hands, Seaborn said.

Addressing questions surrounding the recent increase in the de minimis level from $200 to $800 (see 1603010043), Seaborn said the transition changes little from FDA’s perspective. FDA will “still focus our resources on higher-risk products coming in, regardless of the value,” and will continue to request formal entry on products valued at less than $2,500, including Section 321 shipments, for high risk products, he said. Prior notice is still required regardless of value. FDA is currently looking at its internal policies for Section 321 shipments, and working with the Border Interagency Executive Committee (BIEC) to harmonize Section 321 policies where possible, Seaborn said. Longer term, the BIEC is currently discussing the possibility of giving PGAs access to the Automated Manifest System (AMS), and how PGAs would build manifest data into their targeting and admissibility systems, he said.