05-2212. Chemical Mixtures; Temporary Waiver of Import/Export Requirements

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Temporary waiver of import/export requirements.

SUMMARY:

On December 15, 2004, the Drug Enforcement Administration (DEA) published a final rule that implemented regulations pertaining to chemical mixtures that contain any of 27 listed chemicals regulated under the Controlled Substances Act (21 U.S.C. 801 et seq.). That rulemaking became effective on January 14, 2005.

Following publication of the final rule, certain segments of the chemical industry expressed concerns to DEA regarding difficulty in fully complying with DEA import/export notification requirements as specified in 21 CFR part 1313 by this deadline. Therefore, in order to avoid interruption of legitimate import/export distributions, DEA is providing a waiver of the import/export reporting requirements as specified in 21 CFR part 1313 until May 14, 2005. As such, regulated persons will temporarily not be required to submit advance notification for import, export and transshipment transactions for chemical mixtures regulated solely due to the presence of these 27 listed chemicals until May 14, 2005. This temporary waiver applies only to import, export and transshipment notification requirements; all other chemical control requirements set forth in the final rulemaking published on December 15, 2004, shall remain in full force and effect.

DATES:

Effective February 4, 2005. The new deadline for providing import, export and transshipment notification for regulated chemical mixtures containing these 27 listed chemicals will be May 14, 2005.

FOR FURTHER INFORMATION CONTACT:

Christine A. Sannerud, Ph.D., Chief, Drug & Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, telephone [phone]

SUPPLEMENTARY INFORMATION:

On December 15, 2004, the Drug Enforcement Administration (DEA) published a final rule (69 FR 74957) that implemented regulations pertaining to chemical mixtures that contain any of 27 listed chemicals regulated under the Controlled Substances Act (CSA). That rulemaking became effective on January 14, 2005.

Following publication of the final rule concerns were raised by various segments of the chemical industry regarding their difficulty in fully complying with DEA import/export notification requirements as specified in 21 CFR part 1313 by this deadline. DEA received correspondence from two national chemical associations and from one major chemical producer. Additionally, DEA received verbal communication from industry that expressed concerns regarding the large number of potentially affected mixtures and the difficulty industry was having in meeting deadlines for submitting import/export notification. After carefully considering the concerns expressed by industry, DEA has decided to postpone the implementation of the import/export notification requirements as specified in 21 CFR part 1313 until May 14, 2005. This temporary waiver shall apply only to chemical mixtures which became regulated under the December 15, 2004 final rule (69 FR 74957).

While the submission of import, export and transshipment information to DEA is an important provision in countering the potential diversion of these materials, this temporary waiver is being provided to allow industry ample time to ensure their full compliance with CSA import/export regulatory requirements as specified in 21 CFR part 1313. As such, DEA will be temporarily waiving the requirement for regulated persons to submit advance notification for import, export and transshipment transactions for chemical mixtures which are regulated solely due to the presence of the 27 listed chemicals which were the subject of the December 15, 2004 final rule. This temporary waiver applies only to import, export and transshipment notification requirements. All other chemical control requirements set forth in the final rulemaking published on December 15, 2004 (69 FR 74957) shall remain in full force and effect.

The new deadline for providing import, export and transshipment notification for regulated chemical mixtures containing these 27 listed chemicals will be May 14, 2005.

Provisions of December 15, 2004 Final Rule (69 FR 74957) Which Do Not Change

For any person distributing, importing, or exporting any amount of a regulated mixture containing a List I chemical, the CSA requires that person to obtain a DEA registration. DEA recognizes that it is not possible for persons who are subject to the registration requirement to immediately complete and submit an application for registration and for DEA to immediately issue registrations for those activities. Therefore, in order to allow continued legitimate commerce in regulated mixtures, the December 15, 2004 final rule established a temporary exemption from the registration requirement (in 21 CFR 1310.09) for persons desiring to engage in activities with regulated mixtures that are subject to registration requirements, provided that DEA receives a properly completed application for registration or an application for exemption (pursuant to 21 CFR 1310.13) for their chemical mixture(s) on or before February 14, 2005. The temporary exemption from registration for such persons will remain in effect until DEA takes final action on their application(s).

Any person whose application for exemption is subsequently rejected by DEA must obtain a registration with DEA. A temporary exemption from the registration requirement will also be provided for these persons, if DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has not been approved. The deadline for submission of an application for registration, or an application for exemption, remains February 14, 2005 in order to obtain the temporary exemption from registration.

None of the temporary exemptions discussed in this rulemaking suspend applicable federal criminal laws relating to the regulated mixtures, nor does it supersede state or local laws or regulations. All handlers of a regulated mixture must comply with applicable state and local requirements in addition to the CSA regulatory controls.

Dated: January 28, 2005.

William J. Walker,

Deputy Assistant Administrator, Office of Diversion Control.