[Federal Register Volume 66, Number 173 (Thursday, September 6, 2001)]
[Rules and Regulations]
[Pages 46519-46521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22321]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1313

[DEA-197F]
RIN 1117-AA53


Waiver of Advance Notification Requirement To Import Acetone, 2-
Butanone (MEK), and Toluene

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Final rule.

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SUMMARY: This rule finalizes, without change, the Notice of Proposed 
Rulemaking (NPRM) published in the Federal Register on October 25, 
2000, (65 FR 63822; as corrected at 65 FR 67796, November 13, 2000) to 
amend DEA regulations to waive the advance notification requirement to 
import the solvents acetone, 2-Butanone (MEK), and toluene, which are 
regulated as List II chemicals. DEA determined that the advance 
notification requirement is not necessary for these chemicals for 
effective chemical diversion control. No comments to the NPRM were 
received. This change to the regulations will ease regulatory burdens 
for the regulated industry and administrative burdens for DEA.

EFFECTIVE DATE: October 9, 2001.

FOR FURTHER INFORMATION CONTACT: Patricia M. Good, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION:

What Does This Final Rule Accomplish?

    This final rule finalizes, without change, the Notice of Proposed 
Rulemaking (NPRM) published in the Federal Register on October 25, 2000 
(65 FR 63822; as corrected at 65 FR 67796), to amend Title 21, Code of 
Federal Regulations (CFR) Sec. 1313.12 to waive the advance 
notification requirement for imports of the solvents acetone, 2-
Butanone (MEK), and toluene, which are regulated as List II chemicals. 
This rule also finalizes a number of technical corrections to the 
regulations.

By What Authority Is DEA Waiving the Advance Notification Requirement?

    The intent of the chemical control provisions of the Controlled 
Substances Act (CSA) is to curb the diversion of regulated chemicals to 
the illicit manufacture of controlled substances. This diversion can 
occur through distribution, importation and exportation of these 
chemicals. One of the principal components of chemical control with 
respect to imports and exports is the requirement that advance 
notification be provided to DEA prior to an importation or exportation 
of a listed chemical (21 U.S.C. 971). This advance notification allows 
DEA an opportunity to review the transaction and determine whether it 
might result in diversion of the chemical to the illicit manufacture of 
a controlled substance. The advance notification requirement is 
conditioned by the provision that DEA can waive the requirement for 
imports or exports of listed chemicals for which the Administrator 
determines that such advance notification is not necessary for 
effective chemical diversion control (21 U.S.C. 971(e)(3), 21 CFR 
1313.12(c)(2) and 21 CFR 1313.21(c)(2)).

Why Is DEA Waiving the Advance Notification Requirement for Importation 
of Acetone, 2-Butanone (MEK), and Toluene?

    DEA has determined that the advance notification requirement for 
acetone, 2-Butanone, and toluene is not necessary for effective 
chemical diversion control and, therefore, is waiving this requirement 
for these three List II chemicals.
    Acetone, 2-Butanone (MEK) and toluene are widely used as industrial 
chemicals in the United States. The principal concern for DEA in regard 
to these solvents is their use in the illicit manufacture of cocaine. 
Cocaine is manufactured overseas; at this time, it is not manufactured 
in the United States. Diversion of these solvents for illegal 
manufacture of controlled substances has not been identified as a 
significant problem in the United States.

What Comments Did DEA Receive Regarding the Proposed Rule?

    DEA received no comments to the NPRM.

What Will Be Required for Imports of Acetone, 2-Butanone (MEK), and 
Toluene?

    With waiver of the advance notification requirement, importers of 
acetone, 2-Butanone (MEK) and toluene will not be required to submit 
individual DEA Form 486s in advance of each importation. Instead, 
importers will submit summary quarterly reports of all import 
transactions as described in 21 CFR 1313.12(e) pursuant to 21 U.S.C. 
971(e)(3).

What Is the Impact of This Rulemaking on the Regulatory Burden for the 
Regulated Industry?

    This final rule reduces the paperwork burden for the regulated 
industry. Approximately two thirds of all 15-day advance notifications 
of importation (on average 2000 advance notifications annually) are for 
the solvents acetone, 2-Butanone (MEK), and toluene, equating to an 
initial paperwork burden reduction of 420 hours. In lieu of this 
paperwork requirement, DEA is requiring that importers of acetone, 2-
Butanone (MEK) and toluene complete a quarterly summary report of all 
transactions. This quarterly summary report is estimated to impose a 
regulatory burden of 200 hours per year. Therefore, this change creates 
a net reduction of 220 annual paperwork burden hours for the regulated 
industry.

[[Page 46520]]

Technical Corrections to the Regulations

    DEA also proposed a number of technical corrections to the 
regulations, which are finalized in this rulemaking.
    In 21 CFR 1313.12(b) and 21 CFR 1313.21(b) the reference to the 
``Drug Control Section'' is being changed to the ``Chemical Control 
Section'' to reflect organizational changes within DEA. In 21 CFR 
1313.21(e), the text noting that no DEA Form 486 is required for 
exportations subject to 21 CFR 1313.21(c)(2) was inadvertently omitted. 
This text has been reinserted. Further, an error occurred in 21 CFR 
1313.21(e) relating to exports where the word ``importation'', rather 
than the word ``exportation'', was inadvertently used in the sentence: 
``The report shall contain the following information regarding each 
individual importation:''. The word ``exportation'' is being 
substituted to correct this error.

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy Assistant Administrator hereby certifies that this 
rulemaking has been drafted in accordance with the Regulatory 
Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation, and by 
approving it certifies that this regulation will not have a significant 
economic impact on a substantial number of small entities. Waiving the 
15-day advance notification requirement for imports of acetone, 2-
Butanone, and toluene will ease the regulatory burden for the regulated 
industry.

Executive Order 12866

    The Deputy Assistant Administrator further certifies that this 
rulemaking has been drafted in accordance with the principles in 
Executive Order 12866 Section 1(b). DEA has determined that this is not 
a significant regulatory action. This rulemaking will ease regulatory 
burdens for the regulated industry. Therefore, this action has not been 
reviewed by the Office of Management and Budget.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
Sections 3(a) and 3(b)(2) of Executive Order 12988.

Executive Order 13132

    This rulemaking does not preempt or modify any provision of state 
law; nor does it impose enforcement responsibilities on any state; nor 
does it diminish the power of any state to enforce its own laws. 
Accordingly, this rulemaking does not have federalism implications 
warranting the application of Executive Order 13132.

Paperwork Reduction Act

    This rulemaking waives the advance notification requirement for 
acetone, 2-Butanone and toluene. This change creates a net reduction of 
220 annual paperwork burden hours for the regulated industry.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by state, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.

Small Business Regulatory Enforcement Fairness Act of 1996

    This rule is not a major rule as defined by Section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996. This rule 
will not result in an annual effect on the economy of $100,000,000 or 
more; a major increase in costs or prices; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.

Plain Language Instructions

    The Drug Enforcement Administration makes every effort to write 
clearly. If you have suggestions as to how to improve the clarity of 
this regulation, call or write Patricia M. Good, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, telephone (202) 307-7297.

List of Subjects in 21 CFR Part 1313

    Administrative practice and procedure, Drug traffic control, 
Exports, Imports, List I and List II chemicals, Reporting and 
recordkeeping requirements.

    For the reasons set out above, 21 CFR part 1313 is amended to read 
as follows:

PART 1313--[AMENDED]

    1. The authority citation for part 1313 continues to read as 
follows:

    Authority: 21 U.S.C. 802, 830, 871(b), 971.


    2. Section 1313.12 is amended by revising paragraphs (b) and (f) to 
read as follows:


Sec. 1313.12  Requirement of authorization to import.

* * * * *
    (b) A completed DEA Form 486 must be received at the following 
address not later than 15 days prior to the importation: Drug 
Enforcement Administration, P.O. Box 28346, Washington, DC 20038.
    A copy of the completed DEA Form 486 may be transmitted directly to 
the Drug Enforcement Administration, Chemical Control Section, through 
electronic facsimile media not later than 15 days prior to the 
importation.
* * * * *
    (f) The 15 day advance notification requirement set forth in 
paragraph (a) has been waived for imports of the following listed 
chemicals:
    (1) Acetone.
    (2) 2-Butanone (or Methyl Ethyl Ketone or MEK).
    (3) Toluene.
    3. Section 1313.21 is amended by revising paragraph (b) and the 
introductory text of paragraph (e) to read as follows:


Sec. 1313.21  Requirement of authorization to export.

* * * * *
    (b) A completed DEA Form 486 must be received at the following 
address not later than 15 days prior to the exportation: Drug 
Enforcement Administration, P.O. Box 28346, Washington, DC 20038. A 
copy of the completed DEA Form 486 may be transmitted directly to the 
Drug Enforcement Administration, Chemical Control Section, through 
electronic facsimile media not later than 15 days prior to the 
exportation.
* * * * *
    (e) For exportations where advance notification is waived pursuant 
to paragraph (c)(2) of this section, no DEA Form 486 is required, 
however, the regulated person shall file quarterly reports to the Drug 
Enforcement Administration, Chemical Control Section, P.O. Box 28346, 
Washington, DC 20038, by no later than the 15th day of the month 
following the end of each quarter. The report shall contain the 
following information regarding each individual exportation:
* * * * *


[[Page 46521]]


    Dated: August 27, 2001.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 01-22321 Filed 9-5-01; 8:45 am]
BILLING CODE 4410-09-P