[Federal Register: February 4, 2005 (Volume 70, Number 23)]
[Rules and Regulations]
[Page 5925-5926]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04fe05-5]
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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]
BILLING CODE 4410-09-P