[Federal Register Volume 70, Number 23 (Friday, February 4, 2005)]
[Rules and Regulations]
[Pages 5925-5926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2212]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1310 and 1313

[Docket No. DEA-137N]
RIN 1117-AA31


Chemical Mixtures; Temporary Waiver of Import/Export Requirements

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Temporary waiver of import/export requirements.

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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 (202) 307-
7183

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

[[Page 5926]]

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.
[FR Doc. 05-2212 Filed 2-3-05; 8:45 am]
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