[Federal Register: March 1, 2005 (Volume 70, Number 39)]
[Proposed Rules]
[Page 9889-9892]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01mr05-18]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-254P]
RIN 1117-AA90
Control of Sodium Permanganate as a List II Chemical
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Controlled Substances Act (CSA) provides the Attorney
General with the authority to specify, by regulation, additional
chemicals as ``List II'' chemicals if they are used in the manufacture
of a controlled substance in violation of the CSA. The Drug Enforcement
Administration (DEA) is proposing the addition of sodium permanganate
as a List II chemical because of its direct substitutability for
potassium permanganate (a List II chemical) in the illicit production
of cocaine.
As a List II chemical, handlers of sodium permanganate would be
subject to CSA chemical regulatory controls including recordkeeping,
reporting, and import/export requirements. DEA has determined that
these controls are necessary to prevent the diversion of this chemical
to cocaine laboratories.
DEA is also proposing that a cumulative threshold of 55 kilograms
and 500 kilograms be established (respectively) for domestic and
international transactions. As such, all transactions which meet or
exceed these quantities (in a calendar month) shall be considered
regulated transactions, subject to recordkeeping, reporting and/or
import/export notification requirements. Additionally DEA is proposing
that sodium permanganate chemical mixtures having less than or equal to
15 percent sodium permanganate shall qualify for automatic exemption
from CSA chemical regulatory controls pursuant to 21 CFR part 1310.
All handlers of the List II chemical sodium permanganate would also
be subject to the applicable civil and criminal penalty provisions
found in 21 U.S.C. 841, 842, 843, 959 and 960.
DATES: Written comments must be postmarked, and electronic comments
must be sent, on or before May 2, 2005.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-254'' on all written and electronic correspondence.
Written comments being sent via regular mail should be sent to the
Deputy Administrator, Drug Enforcement Administration, Washington, DC
20537, Attention: DEA Federal Register Representative/CCD. Written
comments sent via express mail should be sent to DEA Headquarters,
Attention: DEA Federal Register Representative/CCD, 2401 Jefferson-
Davis Highway, Alexandria, VA 22301. Comments may be directly sent to
DEA electronically by sending an electronic message to
dea.diversion.policy@usdoj.gov. Comments may also be sent
electronically through http://www.regulations.gov using the electronic
comment form provided on that site. An electronic copy of this document
is also available at the http://www.regulations.gov Web site. DEA will
accept attachments to electronic comments in Microsoft word,
WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept
any file format other than those specifically listed here.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud Ph.D., Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, Washington DC 20537 at (202) 307-7183.
SUPPLEMENTARY INFORMATION: The Controlled Substances Act (CSA) and its
implementing regulations, specifically 21 U.S.C. 802(35) and 21 CFR
1310.02(c), provide the Attorney General with the authority to specify,
by regulation, additional chemicals as ``List II'' chemicals if they
are used in the manufacture of a controlled substance in violation of
the CSA. This authority has been delegated to the Administrator of DEA
by 28 CFR 0.100 and redelegated to the Deputy Administrator under 28
CFR 0.104 (subpart R) Appendix section 12.
This Notice of Proposed Rulemaking (NPRM) proposes the addition of
sodium permanganate as a List II chemical. Additionally, this NPRM
proposes that a threshold of 55 kilograms and 500 kilograms be
established (respectively) for domestic and international transactions.
DEA is also proposing that chemical mixtures (containing sodium
permanganate) having less than or equal to 15 percent sodium
permanganate shall qualify for automatic exemption from CSA chemical
regulatory controls pursuant to 21 CFR part 1310. Since DEA recognizes
that the concentration limit exemption criteria cannot identify all
mixtures that should receive exemption status, DEA has implemented an
application process to exempt additional mixtures (21 CFR 1310.13).
This application process was finalized in a Final Rule published in the
Federal Register May 1, 2003 (68 FR 23195). Under the application
process, manufacturers may submit an application for exemption for
those mixtures that do not qualify for automatic exemption. Exemption
status can be granted if DEA determines that the mixture is formulated
in such a way that it cannot be easily used in the illicit production
of a controlled substance and the listed chemical cannot be readily
recovered (i.e., it meets the conditions in 21 U.S.C. 802(39)(A)(v)).
An application may be for a single or a multiple number of
formulations.
Sodium Permanganate Industry and Legitimate Uses
Sodium permanganate is an inorganic oxidant that is a direct
substitute for potassium permanganate. Due to its high solubility in
water, sodium permanganate has distinct advantages over potassium
permanganate in many industrial applications. It is becoming widely
used for industrial purposes, including (1) printed circuit board
production, (2) pharmaceutical and chemical synthesis, (3) soil and
groundwater remediation, (4) metal cleaning formulations, (5) acid mine
drainage and (6) hydrogen sulfide odor control.
DEA has identified only one domestic producer of sodium
permanganate. However, sodium permanganate is also imported into the
United States and there are at least three other major suppliers of
sodium permanganate in the United States.
The U.S. firm that manufactures sodium permanganate distributes it
through 15-20 major authorized distributors and more than 100 branch
distributors. This U.S. supplier has advised DEA that it is aware of
``one
[[Page 9890]]
[sodium permanganate] manufacturer in Germany, more than one
manufacturer in China and at least nine suppliers in other countries.''
Reason for This Control Action
Sodium permanganate is directly substitutable for potassium
permanganate, an important List II chemical used illicitly in the
production of cocaine. Potassium permanganate is widely used as an
oxidizing agent for removing impurities from coca base in the illicit
production of cocaine. Potassium permanganate is utilized because it
produces an aesthetically pleasing, white, crystalline form of cocaine
hydrochloride, which is easily marketed.
Because of its importance in cocaine production, potassium
permanganate has been the target of international cooperative efforts
to monitor potassium permanganate shipments and prevent its diversion.
This effort remains an international priority involving the competent
authorities of 22 countries.
Recently, the world's largest producer of potassium permanganate (a
U.S. company) informed DEA of its recent conversion of production
processes away from potassium permanganate and toward the increased
production and distribution of sodium permanganate. Because of sodium
permanganate's direct substitutability for potassium permanganate, this
company has agreed with DEA concerns regarding the potential illicit
use of sodium permanganate as a direct substitute for potassium
permanganate in cocaine processing. This producer advised DEA that it
would welcome the control of sodium permanganate as a listed chemical.
Even though production of sodium permanganate has historically been
limited, sodium permanganate has been seized by law enforcement at
illicit cocaine laboratories in Latin America. As reported in the 2001
and 2002 Statistical Summary on Drugs compiled by the Organization of
American States (OAS), Inter-American Drug Abuse Control Commission
(CICAD), the Government of Colombia (as reported by the Colombian
Ministerio de Justicia y del Derecho, Direccion Nacional de
Estupefacientes) reported the seizure of 1,400 kilograms of sodium
permanganate in 1997, 236 kilograms in 1998 and 404 kilograms in 1999.
Because of its direct substitutability for potassium permanganate
and increased production, DEA sees the urgent need to regulate sodium
permanganate as a List II chemical to prevent its diversion to cocaine
laboratories. Hence, this NPRM proposes that sodium permanganate become
subject to the same CSA regulatory controls which have been put forth
for potassium permanganate. As such, sodium permanganate would become
subject to List II chemical controls, including recordkeeping,
reporting, and import/export requirements as specified in 21 CFR parts
1310 and 1313.
Regulatory Controls That Would Apply to This Chemical
DEA is proposing that sodium permanganate become subject to the
same chemical controls as apply to potassium permanganate, due to its
direct substitutability in cocaine processing. As a List II chemical,
sodium permanganate would be subject to the chemical regulatory control
provisions and civil and criminal sanctions of the CSA. As such,
recordkeeping, reporting and import/export notification requirements
(as described in 21 CFR parts 1310 and 1313) shall apply. As a List II
chemical, manufacturers, distributors, importers and exporters of
sodium permanganate will not be required to register with DEA pursuant
to the provisions of 21 CFR part 1309.
Handlers of this chemical would be required to maintain records and
meet CSA import/export notification requirements for ``regulated
transactions'' involving sodium permanganate. The CSA (21 U.S.C.
802(39)) defines the term ``regulated transaction'' as a
``distribution, receipt, sale, importation, or exportation of, or an
international transaction involving the shipment of, a listed chemical,
or if the Attorney General establishes a threshold amount for a
specific listed chemical,'' a transaction involving a threshold amount.
The CSA, therefore, provides the Attorney General with authority to
establish a threshold amount for listed chemicals if the Attorney
General so elects.
DEA is proposing the establishment of a threshold of 55 kilograms
for domestic transactions and 500 kilograms for international
transactions. Consequently, all transactions which meet or exceed these
threshold quantities would be considered regulated transactions and be
subject to recordkeeping, reporting and import/export notification
requirements of the CSA.
Regulatory Requirements for Persons Handling Regulated Transactions of
Sodium Permanganate
Records and Reports. The CSA (21 U.S.C. 830) requires certain
records to be kept and reports to be made involving listed chemicals.
Regulations describing recordkeeping and reporting requirements are set
forth in 21 CFR part 1310. A record must be made and maintained for two
years after the date of a regulated transaction involving a List II
chemical. Only a distribution, receipt, sale, importation, or
exportation of a regulated mixture at or above the established
threshold (e.g. 55 kilograms for domestic transactions and 500
kilograms for international transactions) is a regulated transaction
(21 CFR 1300.02(b)(28)).
Each regulated bulk manufacturer of a regulated mixture shall
submit manufacturing, inventory and use data on an annual basis (21 CFR
1310.05(d)). Bulk manufacturers producing the mixture solely for
internal consumption, e.g., formulating a non-regulated mixture, are
not required to submit this information. Existing standard industry
reports containing the required information are acceptable, provided
the information is readily retrievable from the report. 21 CFR 1310.05
requires that each regulated person shall report to DEA any regulated
transaction involving an extraordinary quantity, an uncommon method of
payment or delivery, or any other circumstance that causes the
regulated person to believe that the listed chemical will be used in
violation of the CSA.
Imports/Exports. All import/exports and brokered transactions of
regulated mixtures shall comply with the CSA (21 U.S.C. 957 and 971).
Regulations for importation and exportation of listed chemicals are
described in 21 CFR part 1313.
Administrative Inspection. Places, including factories, warehouses,
or other establishments and conveyances, where regulated persons may
lawfully hold, manufacture, or distribute, dispense, administer, or
otherwise dispose of a listed chemical or where records relating to
those activities are maintained, are controlled premises as defined in
21 CFR 1316.02(c). The CSA (21 U.S.C. 880) allows for administrative
inspections of these controlled premises as provided in 21 CFR part
1316 subpart A.
Specific Requirements That Will Apply to Regulated Chemical Mixtures
Containing Sodium Permanganate
Upon publication of a Final Rule, a chemical mixture that is
regulated because it contains greater than 15 percent sodium
permanganate will be treated as a List II chemical. Transactions that
meet or exceed the cumulative monthly threshold of 55 kilograms for
domestic transactions and 500 kilograms for international
[[Page 9891]]
transactions shall be regulated transactions.
The regulatory requirements for regulated chemical mixtures
containing List II chemicals are the same as for regulated chemical
mixtures containing List I chemicals, except that registration
requirements do not apply. Therefore, the same requirements for records
and reports, imports/exports (except that pertaining to 21 U.S.C. 957),
and administrative inspection, as outlined above, apply to handlers of
List II regulated chemical mixtures.
Persons who submit an application for exemption (21 CFR 1310.13)
and whose application is pending or subsequently denied by DEA would be
required to comply with all chemical control requirements, including
recordkeeping and reporting, effective 30 days from date of publication
of the final rulemaking. Therefore, all transactions of the chemical
mixture would be regulated, if above threshold, while an application
for exemption is pending or awaiting correction. This is necessary
because not regulating these transactions could result in increased
diversion of chemicals desirable to cocaine traffickers.
Potential Impact of Regulation Upon Industry
In an effort to better estimate the potential impact of this
proposed action, DEA conducted an analysis of various data sources
relating to the manufacture, distribution, and use of the
permanganates. This included an analysis of current chemical producers
and marketing directories (to identify companies listing themselves as
sources of these chemicals).
As previously stated in this NPRM, the DEA has identified only a
limited number of companies which distribute sodium permanganate which
has been either domestically produced or imported. While sodium
permanganate has industrial uses, DEA has not been able to identify any
``household'' uses for this chemical. Therefore, the number of firms
that are likely to be affected by this proposed regulation is
relatively small.
This proposed regulation is not considered to have an impact upon a
substantial number of firms, given the limited distribution of this
chemical. Additionally, it is likely that the CSA recordkeeping
requirements are already being met as part of normal business practice.
Since sodium permanganate is being proposed as a List II chemical there
is no registration requirement. Additionally, DEA is proposing a
cumulative threshold of 55 kilograms for domestic transactions and 500
kilograms for international transactions. Therefore, small transactions
involving research quantities of sodium permanganate will not be
subject to regulatory requirements.
Invitation for Input Regarding the Legitimate Uses for These Chemicals
This NPRM solicits input regarding: (1) The nature of the
legitimate sodium permanganate industry; (2) the legitimate uses of
sodium permanganate at all levels of distribution (including industrial
uses and use by individual end-users at the retail level of
distribution); (3) the potential impact such regulatory controls may
have on legitimate industry (particularly with respect to the impact on
small businesses); (4) the potential number of individuals/firms which
may be affected by increased regulatory requirements; and (5) any other
information on the manner of manufacturing, distribution, consumption,
storage, disposal, and uses of sodium permanganate by industry and
others. Comments must be submitted on or before May 2, 2005.
Regulatory Certifications
Regulatory Flexibility Act
The Deputy 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. As noted previously,
this NPRM is not considered to have an impact upon a substantial number
of firms, given the limited distribution of this chemical. Further,
this impact is being limited by the fact that DEA is proposing to list
sodium permanganate as a List II chemical, rather than the more
stringent requirements of a List I chemical. Additionally, it is likely
that the CSA recordkeeping requirements are already being met as part
of normal business practice. The cumulative threshold of 55 kilograms
for domestic transactions and 500 kilograms for international
transactions proposed here would remove from regulatory control small
transactions involving research quantities of sodium permanganate.
Executive Order 12866
The Deputy Administrator further certifies that this rulemaking has
been drafted in accordance with the principles in Executive Order 12866
Section 1(b). It has been determined that this is a ``significant
regulatory action''. Therefore, this action has been reviewed by the
Office of Management and Budget. DEA has identified only one United
States firm which manufactures sodium permanganate. This firm supports
control of sodium permanganate as a List II chemical.
Paperwork Reduction Act
This NPRM proposes the addition of sodium permanganate as a List II
chemical under the Controlled Substances Act. As a List II chemical,
there is no requirement of registration to handle this chemical.
Further, as most persons who handle this product are end-users and, as
such, are not required to maintain records or file reports, there is no
impact on these persons.
Handlers of sodium permanganate that distribute above threshold
quantities, are required to maintain records. Normal business records
are deemed adequate if they contain the information required in 21 CFR
1310.06. As normal business records meet DEA's regulatory requirements,
the maintenance of these records does not fall under the parameters of
the Paperwork Reduction Act. Further, DEA is proposing that persons
importing and exporting this List II chemical in quantities of greater
than 500 kilograms, cumulatively, per month, must provide DEA with
advance notification of these transactions. As DEA does not have any
information on which to base an estimate of the impact of this new
reporting requirement for persons importing or exporting sodium
permanganate in quantities greater than 500 kilograms, cumulatively,
per month, DEA will adjust the burden related to this information
collection (OMB control number 1117-0023 ``Import/Export Declaration:
Precursor and Essential Chemicals'') upon its renewal.
Executive Order 12988
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Reform.
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.
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
[[Page 9892]]
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 $114,000,000 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.
List of Subjects in 21 CFR Part 1310
Drug traffic control, List I and List II chemicals, Reporting and
recordkeeping requirements.
For reasons set out above, it is proposed that 21 CFR part 1310 be
amended as follows:
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES [AMENDED]
1. The authority citation for part 1310 continues to read as
follows:
Authority: 21 U.S.C. 802, 830, 871(b), 890.
2. Section 1310.02 is proposed to be amended by adding a new
paragraph (b)(12) to read as follows:
Sec. 1310.02 Substances covered.
* * * * *
(b) * * *
(12) Sodium Permanganate........................................ 6588
* * * * *
3. Section 1310.04 is proposed to be amended by adding new
paragraphs (f)(2)(i)(H) and (f)(2)(ii)((J) to read as follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(f) * * *
(2) * * *
(i) * * *
(H) Sodium permanganate.......... N/A.......... 500
kilograms.
* * * * *
(ii) * * *
(J) Sodium permanganate.......... N/A.......... 55
kilograms.
* * * * *
4. Section 1310.12 is proposed to be amended by revising paragraph
(c) introductory text and adding to the table in paragraph(c) an entry
in alphabetical order for ``Sodium Permanganate'' to read as follows:
Sec. 1310.12 Exempt chemical mixtures.
* * * * *
(c) Mixtures containing a listed chemical in concentrations equal
to or less than those specified in the ``Table of Concentration
Limits'' are designated as exempt chemical mixtures for the purpose set
forth in this section. The concentration is determined for liquid-
liquid mixtures by using the volume or weight and for mixtures
containing solids or gases by using the unit of weight.
Table of Concentration Limits
----------------------------------------------------------------------------------------------------------------
DEA chemical
code number Concentration (percent) Special conditions
----------------------------------------------------------------------------------------------------------------
List I Chemicals.
* * * * * * *
List II Chemicals.
* * * * * * *
Sodium Permanganate.................... 6588 15% by Weight.............
* * * * * * *
----------------------------------------------------------------------------------------------------------------
Dated: December 30, 2004.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05-3913 Filed 2-28-05; 8:45 am]
BILLING CODE 4410-09-P