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DEA Proposes Overhaul of Import/Export Regs, Would Require Electronic Filing of Permits, Declarations

The Drug Enforcement Administration is proposing changes to its regulations that would require electronic filing of permit applications, import and export declarations, and other required filings and reports for the importation and exportation of controlled substances, listed chemicals, and tableting and encapsulating machines. The agency’s proposed rule (here) would eliminate paper filing of most DEA-required submissions entirely, instead requiring importers and exporters to file via the DEA Office of Diversion Control “secure network application,” DEA said. DEA would then provide information to CBP “to validate importations subject to DEA regulations,” it said.

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Applications for transshipment permits and advance notifications of transshipments would still be allowed to be submitted on paper, DEA said. Electronic filing of this data would not be “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. For other filings and reports, allowing continued paper submission would needlessly increase the burden on agency staff, DEA said. “If importers and exporters were permitted to continue submitting paper documents, the DEA would have to manually transcribe the paper information into an electronic format for transmission to the [International Trade Data System, or] ITDS. Such an intermediary step would cause unnecessary delay and is subject to error.”

The secure network application will be accessible via the DEA Office of Diversion Control website. 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. Importers and exporters would also use the website to obtain information on approved permits and DEA’s receipt of completed declarations, notices, returns and reports.

DEA to Assign Unique Identifiers After Submission Complete

Applications, declarations, notices and reports filed through the electronic system would “generally” 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 would be assigned after DEA reviews the filing for completeness and accepts it. The permit number would be issued once DEA approves the permit application. The current Web Tracking Number would still be assigned automatically, but would not signify that the submission has been accepted.

Unique identifier to access data, provide to broker for release. Importers and exporters would use the assigned permit or transaction identification number to access the filing via the secure network application. The importer or exporter would then be “responsible for forwarding official record information to their broker or any other of their agents needing the information contained therein to complete the release process through customs.”

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” would be prohibited without resubmission of the permit application or declaration and issuance of a new permit or transaction identification number, DEA said. “For example, if a customs officer denied release of controlled substances at the port of entry because of a violation of another agency’s regulation (e.g., U.S. Food and Drug Administration), customs officials would not allow entry until after the reason for denial was adequately addressed and the DEA has issued a new permit or transaction identification number,” it said.

Some amendments no longer allowed. Importers and exporters would still be allowed to make some amendments to their permits and declarations, but other amendments would no longer be allowed. For example, DEA is proposing to no longer allow importers and exporters to amend filed import and export declarations to add a new controlled substance or replace a controlled substance with another controlled substance, though they would still be able to remove a controlled substance. Similarly, DEA would no longer allow importers and exporters to amend information on the authorization to import or export from a foreign government. See DEA’s notice for more changes to allowed amendments.

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

Import and export declarations for controlled substances and listed chemicals would 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 would 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. “The 15-day advance notification period currently required by DEA regulations is now used to review notifications. Under this proposal, that review period would occur prior to the issuance of the transaction identification number. Therefore, the DEA would no longer need additional processing time after the issuance of the transaction identification number.” However, DEA would retain the 15-day period “to ensure enough time for the DEA to review the submission for completeness and conduct any necessary follow-up prior to the import/export transaction.”

Option to deem filed on date of submission. DEA is proposing the option of deeming a submission filed on the date it is submitted, rather than the date the transaction number was submitted, if a listed chemical import or export declaration or other filing was complete at the time of filing and no additional follow-up is required. “However, if a chemical importer or exporter made a submission on the last day that would comply with the reporting deadline, and DEA review subsequently found the submission not to be complete, then he or she would be in violation of the regulation,” 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.” However, “with the implementation of the ITDS, it would be difficult for customs officers to clear a shipment of relevant listed chemicals without first receiving appropriate information from the DEA.” Under the proposal, DEA would still grant waivers, but would no longer waive the full 15 days. Instead, the importer or exporter would still have to provide at least three days' advance notice.

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

DEA is proposing 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 would be submitted via the electronic secure network application, and be issued a transaction identification number upon its acceptance. The form would have to 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 proposing amendments 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 would expire after 180 days, rather than six months. “This change corresponds with business rule policies that will be built into the DEA’s electronic systems of records for the impacted applications, notices, and other filings that will be required to be electronically submitted to the DEA.”

(See the proposed rule for more changes, including updates to definitions, new requirements for reporting of shipments of tableting or encapsulating machines that CBP denied release, and requirements for new electronic reports.)