Implementation of the Combat Methamphetamine Epidemic Act of 2005; Notice of Transfers Following Importation or Exportation; Temporary Stay of Certain Provisions

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Interim final rule with request for comment; temporary stay of provisions.

SUMMARY:

On April 9, 2007, the Drug Enforcement Administration (DEA) published an Interim Final Rule with Request for Comment in the Federal Register (72 FR 17401) implementing the provisions of section 716 of the Combat Methamphetamine Epidemic Act of 2005 (CMEA) (21 U.S.C. 971 as amended), enacted March 9, 2006, which required additional reporting for import, export, and international transactions involving all List I and List II chemicals. Subsequent to publication of the Interim Final Rule, DEA received both written and verbal comments from the regulated industry requesting the delay of the effective date of the rulemaking to allow industry more time to fully comply with the new provisions. The rule became effective May 9, 2007. After careful consideration of the comments received, DEA is temporarily staying the provisions of the Interim Final Rule with Request for Comment published April 9, 2007, by 30 days, from May 9, 2007 to June 8, 2007.

DATES:

Effective May 22, 2007, through June 7, 2007, the provisions of 21 CFR 1313.12(c)(1)(ii), 1313.13(c)(5), 1313.16, 1313.17, 1313.26, 1313.27, 1313.32(d), 1313.32(e), and 1313.35 are temporarily stayed.

FOR FURTHER INFORMATION CONTACT:

Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537 at (202) 307-7297.

SUPPLEMENTARY INFORMATION:

Background

On March 9, 2006, the President signed the Combat Methamphetamine Epidemic Act of 2005 (CMEA), which is Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005 (Pub. L. 109-177). On April 9, 2007, the Drug Enforcement Administration (DEA) published an Interim Final Rule with Request for Comment (72 FR 17401) implementing section 716 of the CMEA. That section addressed the importation, exportation, and international transactions of all List I and List II chemicals. Briefly, section 716 of the CMEA (21 U.S.C. 971 as amended) 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. With implementation of the Interim Final Rule with Request for Comment, importers, exporters, brokers, and traders are required to notify DEA, before the transaction is to take place, of certain information regarding their downstream customers. This person is referred to as the “transferee” of the United States importer, exporter, broker or trader. Notification occurs on a new DEA Form 486. If the transferee changes, or the quantity of the chemical is increased after initial notification to DEA, the importer, exporter, broker or trader must file an amended DEA Form 486 with DEA. Within 30 days after the importation, exportation, or international transaction is completed, the importer, exporter, broker, or trader must send DEA a return declaration containing information regarding the transaction. The requirements of section 716 and the implementing regulations were discussed extensively in DEA's Interim Final Rule with Request for Comment published April 9, 2007. This Interim Final Rule became effective May 9, 2007.

Comments Received

Subsequent to publication of the Interim Final Rule, DEA received two written requests for a delay of the effective date of the rule, one from a national chemical association and the other from a large chemical company. Commenters indicated that more time was needed to fully comply with the provisions of the Interim Final Rule. Commenters also sought clarification regarding procedural implementation of the rule. DEA also received verbal communications from other organizations and individual registrants regarding procedural concerns and requests for clarification regarding the rule.

Temporary Stay of Provisions

After careful consideration of the concerns expressed by the regulated industry, DEA is temporarily staying certain provisions of the Interim Final Rule with Request for Comment published April 9, 2007. Specifically, DEA is temporarily staying the following provisions:

• The waiver of the 15-day advance notification requirement for importations of a listed chemical for which the importer intends to transfer the listed chemical to a person who is a regular customer of the chemical;
• The requirement that importers, exporters, brokers and traders notify DEA of the transferee of the listed chemical;
• The requirement that importers, exporters, brokers and traders amend the advance notification (DEA Form 486) if the transferee changes or the quantity of the chemical to be transferred increases; and
• The requirement that importers, exporters, brokers and traders file return declarations regarding importations, exportations, and international transactions with DEA.

These provisions are being temporarily stayed until June 8, 2007.

This temporary stay applies only to those provisions implemented by section 716 of CMEA. All other provisions regarding the importation, exportation, and international transactions involving List I and List II chemicals remain in full force and effect.

Implementation of the Interim Final Rule Published April 9, 2007

The following implementation guidance is provided pursuant to the temporary stay of 21 CFR 1313.12(c)(1)(ii), 1313.13(c)(5), 1313.16, 1313.17, 1313.26, 1313.27, 1313.32(d), 1313.32(e), and 1313.35.

Effective June 8, 2007, all United States importers, exporters, brokers and traders of List I and List II chemicals must use the revised DEA Form 486 to notify DEA of their imports, exports, and international transactions. This revised form is available on the Diversion Control Program Web site, http://www.deadiversion.usdoj.gov.

Persons who submit import, export, and international transaction advance notifications to DEA on the new form prior to June 8, 2007, are not required to provide a return declaration to DEA regarding those transactions.

Effective June 8, 2007, all persons previously granted regular importer status will no longer hold that status. Every import of a List I and List II chemical must be reported to DEA not later than 15 days prior to the proposed importation. This report must include the name of the person to whom the chemical is proposed to be transferred and the amount of the chemical proposed to be transferred. As DEA discussed in the April 9, 2007, Interim Final Rule, DEA will evaluate each proposed importation based not only on the chemical to be imported but on the transferee information supplied by the importer as well. This process will allow for the establishment of regular customer status by transferees of United States importers, and for establishment of regular importer status by importers importing a specific listed chemical intended for sale to a specific customer.

Effective June 8, 2007, all persons importing, exporting, and conducting international transactions involving List I and List II chemicals must provide return declarations to DEA.

Pursuant to the authority of the Attorney General to promulgate and enforce rules and regulations under the Controlled Substances Act (21 U.S.C. 871(b)), as delegated to the Deputy Assistant Administrator of the Office of Diversion Control by 28 CFR Part 0, Appendix to Subpart R, section 7, effective May 22, 2007, through June 7, 2007, the provisions of 21 CFR 1313.12(c)(1)(ii), 1313.13(c)(5), 1313.16, 1313.17, 1313.26, 1313.27, 1313.32(d), 1313.32(e), and 1313.35 are temporarily stayed.