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DEA Interim Final Rule Amends Reporting Requirements for Imports, Exports Involving List I and II Chemicals, Etc.

The Drug Enforcement Administration has issued an interim final rule, effective May 9, 2007, to require additional reporting for import, export, and international transactions involving all List I and List II chemicals, and to implement section 716 of the Combat Methamphetamine Epidemic Act of 2005 (CMEA).

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Written comments must be postmarked, and electronic comments must be sent, on or before May 9, 2007.

(Among other things, Section 716 of the CMEA extends the current reporting requirements, as well as the current exemption for regular importers and regular customers, to post-import and post-export transactions of List I and List II chemicals.)

Highlights of DEA's Interim Final Rule

DEA's interim final rule includes the following amendments:

Revised DEA Form 486. DEA is revising the existing DEA Form 486, Import/Export Declaration. Changes being made include (partial list):

changing the title of the form to "Import/Export Declaration for List I and List II Chemicals" to more accurately characterize the use of the form;

adding a check box for "international transaction" in addition to existing fields for "import" and "export;" and

adding fields for reporting by importers of the person to whom the listed chemical will be transferred, the downstream customer, per requirements of the CMEA, etc.

(Effective May 9, 2007, all U.S. importers and exporters of List I and List II chemicals must use the revised DEA Form 486 to notify DEA of their imports and exports.)

Only "regular" importers/customers may qualify for waiver of advance notice. 21 CFR 1313.12 (Requirement of authorization to import) is amended by revising paragraph (c) to add the requirement that, to qualify for a waiver of the 15 day advance notice, not only does the importer have to be known to DEA as a regular importer, but also that the customer must meet the requirements in 21 CFR 1313.05 to be regarded as a regular customer.

All persons previously granted regular importer status will be required to provide advance notification of imports with information regarding transferees, even for customers that they did business with in the past. If the 15-day notification period elapses without DEA taking action, then that importer is granted regular importer status for all imports of that particular chemical intended for the specified customer.

Importer must provide information on transferee. 21 CFR 1313.13 (Contents of import declaration) is amended by requiring the importer to provide information regarding the person or persons to whom the importer intends to transfer the chemical.

Specified transfer requirements for importers, exporters, brokers/traders. 21 CFR 1313.16 is added to specify requirements regarding transfers after importation, 21 CFR 1313.26 is added to specify requirements regarding transfers after exportation, and 21 CFR 1313.32 is amended to specify requirements for brokers and traders regarding international transactions. These requirements specify what the U.S. importer, exporter, broker, or trader must do if an originally planned sale falls through and the importer or exporter arranges a subsequent spot market sale.

DEA states that for brokers and traders, the situation is somewhat more complicated because the broker or trader does not control the sale. If a transaction is not completed, the broker or trader could be asked to find another buyer for the chemical or the broker or trader may not be involved in arranging the subsequent sale. If the broker or trader arranges a subsequent sale to replace the previously arranged transaction, this transaction is a new transaction and must be reported as such; a return declaration must be filed when the transaction is completed.

Return declaration must be sent to DEA within 30 days of transaction. 21 CFR 1313.17(a), 1313.27(a), and 1313.35(a) are added to specify the requirement that within 30 days of the completion of a transaction, the importer, exporter, broker, or trader must send DEA a return declaration containing information regarding the transaction, including the name of the transferee, date the import, export, or international transaction and any subsequent transfer occurred, the name of the chemical transferred, the actual quantity transferred, the container, and any other information that DEA may specify.

Amendment to DEA Form 486 must be filed if not originally completed. 21 CFR 1313.17(b), 1313.27(b), and 1313.35(b) are added to specify the requirement that if an importation, exportation, or international transaction reported on a DEA Form 486 fails to be completed, the importer, exporter, broker, or trader must file an amendment to the Form 486 to notify DEA.

Revision of definitions for "established business relationship," etc. Certain definitions relating to listed chemicals in 21 CFR 1300.02 are being revised or amended. The definition of "established business relationship" is being revised to remove language regarding foreign customers; this definition is now a general definition relating to any business relationship, either import or export. Further, parts of this definition are moved to new 21 CFR 1313.05 (Requirements of an established business relationship).

The definition of "established record as an importer" is being revised by moving certain information into new 21 CFR 1313.08. Finally, the definition of "regular customer" is being revised to update the cross reference.

-written comments must be postmarked/electronic comments must be sent on or before May 9, 2007

DEA contact - Mark Caverly (202) 307-7297

DEA interim final rule (D/N DEA-292I, FR Pub 04/09/07) available at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/07-1718.pdf