DEA Issues Final Rule Requiring Electronic Filing of Permits, Declarations, Ending ACE Pilot

Under the final rule, "DEA registrants or regulated persons applying for permits (DEA Forms 161, 161R, 161R-EEA, and 357) or filing notifications or reports with the DEA will apply or file directly with DEA electronically through the Diversion Control Division secure network application," the agency said. Import and export declarations (Forms 236, 486 and 486A) are also replaced with an electronic process, it said. "Upon receipt of a complete declaration through the Diversion Control Division secure network application, DEA will provide the importer or exporter with the notice of receipt that must then be filed with CBP as part of the CBP import or export filing through ACE, or any successor system. DEA will also transmit the declaration information electronically to CBP so that customs officers can validate importations and exportations subject to DEA regulations," the agency said.

Applications for transshipment permits and advance notifications of transshipments will still be allowed to be submitted on paper, DEA said. Electronic filing of this data is not “feasible” because foreign internet users are blocked by the Justice Department’s firewall and will not be able to access the secure network application for electronic filing, it said.

The secure network application is accessible via the DEA Office of Diversion Control website (here). The system will automatically alert users if they try to submit an application, declaration, notice, report or other required submission but do not complete all required fields or enter data that is not valid or is inaccurate, DEA said in its proposed rule (see 1609150034), largely unchanged in the final rule. Importers and exporters will also use the website to obtain information on approved permits and DEA’s receipt of completed declarations, notices, returns and reports, it said.

The final rule takes effect Jan. 30, though compliance with the final rule's provisions isn't required until June 27, 2017, DEA said. As of Jan. 30, DEA will end its ACE pilot, having judged the pilot has "successfully tested the functionality for electronic submission of data related to the importation and exportation of controlled substances and listed chemicals," it said. "At that time, all importers, exporters, and brokers will be able to use ACE to electronically file required data and documentation associated with the importation and exportation of controlled substances and listed chemicals," DEA said.

DEA to Assign Unique Identifiers After Submission Complete

Applications, declarations, notices and reports filed through the electronic system will not be deemed filed by the agency until DEA assigns a “single use, randomly-generated, unique identifier” in the form of a “transaction identification number,” or a “permit number” in the case of permit applications, DEA said. The transaction identification number for import and export declarations, notices and reports will be assigned after DEA reviews the filing for completeness and accepts it. The permit number will be issued once DEA approves the permit application. Importers and exporters will use the assigned permit or transaction identification number to access the filing via the secure network application. In its proposed rule, DEA said that the current Web Tracking Number will still be assigned automatically, but does not signify that the submission has been accepted.

Refiling required if shipment denied release. Importation or exportation of any shipment denied release by CBP at the port of entry or port of export “for any reason," including denials not based on violations of DEA regulations, will have to be reported to DEA within five business days, DEA said. The agency will prohibit importation or exportation of any shipment denied release for any reason without resubmission of the permit application or declaration and issuance of a new permit or transaction identification number, DEA said.

Some amendments no longer allowed. Importers and exporters will still be allowed to make some amendments to their permits and declarations, but other amendments will no longer be allowed. For example, DEA will no longer allow importers and exporters to amend filed import and export permits and declarations to add a new controlled substance or replace a controlled substance with another controlled substance. Similarly, DEA will no longer allow importers and exporters to amend information on the authorization to import or export from a foreign government. Amendments that affect the total base weight of a controlled substance, other than those amending a permit when a shipment barely exceeds the allowed amount, will have to be made at least three days before the date of release by a customs officer, DEA said. All other amendments have to be filed one day in advance, it said.

Advance Notice of 15 Days Still Required, but May Proceed if Accepted Sooner

Import and export declarations for controlled substances and listed chemicals still need to be filed at least 15 days in advance of the anticipated date of release by a customs officer at the port of entry or export. However, importers and exporters will be able to proceed with the import or export transaction as soon as the transaction identification number has been issued, regardless of whether 15 days have elapsed, DEA said.

Listed chemical waiver period reduced. Currently, DEA may grant a waiver of the 15-day advance notice requirement for listed chemical imports by “regular importers” and export transactions with “regular customers.” DEA will still grant these waivers, but will no longer waive the full 15 days. Instead, the importer or exporter will have to provide at least three days' advance notice.

Declarations now expire. DEA is setting an expiration date for declarations of 180 days after a declaration is deemed filed by DEA, consistent with the 180-day expiration date for permits, it said.

Tablet and Encapsulated Machine Import/Export Notices Required 15 Days in Advance

DEA is requiring the submission of new DEA Form 452, Reports for Regulated Machines, for imports, exports and domestic regulated transactions of tableting and encapsulating machines, it said. The new form will be submitted via the electronic secure network application, and be issued a transaction identification number upon its acceptance. The form must be submitted to DEA 15 days in advance of the date of arrival at the port of entry or port of export. Currently, these notifications are due “on or before the date of importation or exportation.”

Deadlines Changed to Calendar Days

DEA is making changes throughout its import and export regulations to provide that expiration period, filing dates and other deadlines are calculated as calendar days unless otherwise noted. For example, import and export permits now expire after 180 days, rather than six months.

(See the final rule for more changes, including updates to definitions, requirements for new electronic reports, and new provisions for unlimited re-exportation of controlled substances within the European Economic Area.)

(Federal Register 12/30/16)