AAEI Takes Action on ACE as Deadline Approaches
August 31, 2016
AAEI has alerted the Department of Homeland Security (DHS) and the Food and Drug Administration (FDA) to the possibility of major problems for importers and exporters in the face of the upcoming October 1, 2016 mandatory transition date for the Automated Commercial Environment (ACE), which requires that filings can become completely electronic in ACE.
AAEI sent a letter to DHS Deputy Secretary Alejandro Mayorkas stating that the deadline set by US Customs and Border Protection (CBP) jeopardizes two very important programs for US importers and exporters: reconciliation and drawback.
In the letter, AAEI states, “CBP has not been able to make these substantial new record sets available for software providers and trade filers to test transmissions and messages in ACE. Moreover, no business rules or necessary regulatory changes have been promulgated, and CBP personnel have not been trained on these new processes, and likely will not be trained, until a few weeks before the implementation date.”
AAEI is requesting CBP to immediately make drawback and reconciliation filings available fully in the certification environment so that software providers, filers and claimants can test the electronic processes and provide CBP with feedback to ensure that these systems work correctly before shutting down ACS filings. AAEI also requests CBP to implement drawback and reconciliation in the ACE production environment on October 1st, allowing companies who are ready to file despite the short testing period to begin testing the system in production.
AAEI also filed comments with the FDA on the agency’s requirements for import data in ACE, despite the agency’s denial for an extension to file them. AAEI noted that “there is confusion within FDA about data elements that are optional and mandatory…. How many data elements being requested are what the FDA already have? Why are we being asked to submit this on a transactional basis if it is already retained by FDA?”
AAEI added, “It is a huge burden on the trade and FDA and all government systems to provide all this identical and repetitive data on every single line of every single entry into perpetuity.”
The comments include specific concerns with the FDA’s ACE requirements, including Scope/Applicability; Definitions; Data Elements that Must Be Submitted in ACE for FDA-Regulated Products; Human Drugs; Animal Drugs; Medical Devices; Food; Biological Products, HCT/Ps, and Related Drugs and Medical Devices; and, Technical Amendments.
As AAEI put it in the comments, “The FDA’s Proposed Rule would be a huge drain on the resources of companies who need to generate, furnish and retain such a large set of data.”