CBP Announces ACE PGA Message Set Pilots for FDA Imports

CBP is seeking pilot participants to test Food and Drug Administration data filing and release through the Automated Commercial Environment (ACE), said CBP in a notice (here). The FDA partner government agency (PGA) message set pilot will test the submission of electronic "data elements required by the FDA’s cargo admissibility process under the auspices of ACE for those commodities regulated by the FDA that are being imported or offered for import" into the U.S., said CBP.

The pilot is open to brokers and self-filers who can file ACE Entry Summaries certified for cargo release and file prior notices or entries for FDA-regulated goods, said CBP. The pilot will test electronic filing of data elements currently required by FDA for formal and informal consumption entries. For FDA-regulated imports, the FDA collects data on FDA product codes, country of production, manufacturer and shipper information and ultimate consignee. The FDA also accepts Affirmation of Compliance codes that a filer may use to help expedite the review process.

Upon "successful completion of the FDA PGA Message Set test, it is anticipated that CBP will decommission the legacy" Automated Commercial System/Operational and Administrative System for Import Support interface for the new ACE/OASIS interface, said CBP. The use of ACE and the FDA message set "will enable the trade community to have a CBP-managed “single window” for the submission of data required by the FDA during the cargo importation and review process," CBP said. "For FDA-regulated food products requiring prior notice, the necessary PGA data elements must be submitted prior to the time of arrival of the merchandise."

Although the notice doesn't include a firm start date, CBP said the pilot actually began last week (here). Test participants "may be subject to civil and criminal penalties, administrative sanctions, liquidated damages, or discontinuance from participation in this test," for several reasons, including a failure to deposit duties in a "timely manner," said CBP. The pilot will initially only be conducted at certain ports of entry, as listed in CBP’s PGA message set pilot implementation schedule. Requests to participate in the APHIS pilot should be emailed to steven.j.zaccaro@cbp.dhs.gov, with the subject line “PGA Message Set FDA Test FRN-Request to Participate.”

(Federal Register 08/27/15)