[Federal Register: March 12, 2007 (Volume 72, Number 47)]
[Rules and Regulations]
[Page 10925-10928]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12mr07-8]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-137F3]
RIN 1117-AA31
Exemption of Chemical Mixtures
AGENCY: Drug Enforcement Administration (DEA), U.S. Department of
Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: On December 15, 2004, the Drug Enforcement Administration
(DEA) published a Final Rule corrected January 4, 2005) that
implemented new regulations concerning chemical mixtures that contain
any of the 27 listed chemicals. The Final Rule added a new provision
not previously raised by DEA in any proposed rulemaking. This newly
introduced provision exempted domestic and import transactions in
chemical mixtures that are regulated solely due to the presence of the
List II solvent chemicals acetone, ethyl ether, 2-butanone, or toluene
from the Controlled Substances Act (CSA) recordkeeping and reporting
requirements. Because this exemption was not previously proposed in any
rulemaking, DEA implemented this exemption on an interim basis and
requested public comment on this exemption provision.
Based upon a review of all comments, DEA is finalizing this
exemption. As such, domestic and import transactions in chemical
mixtures containing the List II chemicals acetone, ethyl ether, 2-
butanone, and toluene shall be exempt from CSA chemical recordkeeping
and reporting requirements.
DATES: This Final Rule is effective March 12, 2007.
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:
I. Background
Historical Legal Status of Chemical Mixtures
The Chemical Diversion and Trafficking Act of 1988 (CDTA), (Pub. L.
100-690) created the definition of ``chemical mixture'' (21 U.S.C.
802(40)), and exempted chemical mixtures from regulatory control. The
CDTA established 21 U.S.C. 802(39)(A)(vi), as amended by Title VII of
Public Law 109-177, to exclude ``any transaction in a chemical
mixture'' from the definition of a ``regulated transaction.'' The
exemption of all chemical mixtures, however, provided traffickers with
an unregulated source for obtaining listed chemicals for use in the
illicit manufacture of controlled substances.
To remedy this situation, the Domestic Chemical Diversion Control
Act of 1993 (Pub. L. 103-200) (DCDCA), enacted in April 1994, subjected
chemical mixtures containing listed chemicals to CSA regulatory
requirements, unless specifically exempted by regulation. The DCDCA,
therefore, subjected all regulated chemical mixtures to recordkeeping,
reporting, and security requirements of the CSA. Additionally, the
DCDCA added a registration requirement for handlers of regulated List I
chemical mixtures.
The DCDCA, however, also amended 21 U.S.C. 802(39)(A)(vi), as
amended by Title VII of Public Law 109-177, to provide the Attorney
General with the authority to establish regulations exempting chemical
mixtures from the definition of a ``regulated transaction'' ``based on
a finding that the mixture is formulated in such a way that it cannot
be easily used in the illicit production of a controlled substance and
that the listed chemical or chemicals contained in the mixture cannot
be readily recovered'' (21 U.S.C. 802(39)(A)(vi) as amended by Title
VII of Pub. L. 109-177). This authority has been delegated to the
Administrator of DEA by 28 CFR 0.100 and redelegated to the Deputy
[[Page 10926]]
Administrator under 28 CFR Appendix to Subpart R, section 12.
Prior to publication of a final rulemaking, chemical mixtures
containing listed chemicals have been treated as exempt from CSA
regulatory control. Regulations regarding the exemption of chemical
mixtures were initially proposed by DEA on October 13, 1994, as part of
its proposed regulations to implement the DCDCA (59 FR 51888). In
response to industry concerns, the proposed regulations were withdrawn
on December 9, 1994, (59 FR 63738).
DEA proposed new regulations regarding the exemption of chemical
mixtures by publishing a new NPRM entitled ``Exemption of Chemical
Mixtures'' on September 16, 1998 (63 FR 49506). DEA proposed the
following three-tiered approach to identify which chemical mixtures
qualify for automatic exemption: (1) It contains a listed chemical at
or below an established concentration limit; or (2) it falls within a
specifically defined category; or (3) the manufacturer of the mixture
applies for and is granted a specific exemption for the product.
On December 15, 2004, DEA published a final rule which specified
criteria used to determine whether chemical mixtures qualify for
automatic exemption from CSA chemical regulatory controls for 27 listed
chemicals (69 FR 74957; corrected at 70 FR 294, January 4, 2005). Those
chemical mixtures that do not meet the exemption criteria are treated
as regulated chemicals and therefore, subject to CSA chemical
regulatory controls.
Chemical Mixture Definition
Title 21 U.S.C. 802(40) defines the term ``chemical mixture'' as
``a combination of two or more chemical substances, at least one of
which is not a List I chemical or a List II chemical, except that such
term does not include any combination of a List I chemical or a List II
chemical with another chemical that is present solely as an impurity.''
Therefore, a chemical mixture contains any number of listed chemicals
along with any number of non-listed chemicals. A combination of only
listed chemicals is, therefore, not a chemical mixture pursuant to the
CSA definition. As such, the regulatory controls pertaining to each
individual listed chemical are applicable.
It is DEA's longstanding policy that the combination of a listed
chemical in an inert carrier is not considered a chemical mixture. An
inert carrier can be any chemical that does not interfere with the
listed chemical's function but is present to aid in the delivery of the
listed chemical so it can be used in some chemical process. Examples
include, but are not limited to, solutions of listed chemicals such as
methylamine in water or hydrogen chloride dissolved in water or
alcohol. Persons who question if their formulations are chemical
mixtures should contact DEA for guidance.
New Interim Chemical Mixture Exemption Category
The Final Rule published on December 15, 2004, (69 FR 74957;
corrected at 70 FR 294, January 4, 2005) also added, on an interim
basis, a new exemption category. DEA determined that certain solvent-
based mixtures involving silicon-based products, paint-related
materials, and other solvent-based chemical mixtures containing
acetone, ethyl ether, 2-butanone, and toluene are not likely to be
diverted domestically. These solvent chemicals are mostly a concern
because they are used in cocaine and heroin processing, which occurs
outside the United States.
Therefore, the December 15, 2004 rulemaking created a new exemption
category for these mixtures. Domestic and import transactions in
chemical mixtures that are regulated solely due to the presence of the
List II solvent chemicals acetone, ethyl ether, 2-butanone, or toluene
were removed, on an interim basis, from the definition of a regulated
transaction by adding a new paragraph to 21 CFR 1310.08. Methyl
isobutyl ketone, also a List II solvent chemical, was not included
because domestic and import transactions in that chemical have already
been excluded from the definition of a regulated transaction at 21 CFR
1310.08.
This new exemption (for domestic and import transactions in
chemical mixtures containing the List II chemicals acetone, ethyl
ether, 2-butanone, and toluene) was not discussed in the original NPRM
published on September 16, 1998 (63 FR 49506). Therefore, this
exemption was implemented on an interim basis with opportunity for
public comment in the December 15, 2004 rulemaking (69 FR 74957;
corrected at 70 FR 294, January 4, 2005). DEA solicited comments on
this portion of the rulemaking.
II. Comments Received Regarding the Interim Regulations
DEA received three comments in response to the December 15, 2004,
rulemaking (69 FR 74957) from interested parties. Two comments were
from trade associations, and one comment was from a chemical
manufacturer. In general, the comments supported efforts by DEA to
regulate chemical mixtures that have potential use to drug traffickers.
Each comment specifically supported finalization of the exemption for
domestic and import transactions for chemical mixtures containing the
List II solvent chemicals acetone, ethyl ether, 2-butanone, and
toluene.
Two comments, however, requested that the exemption be expanded to
include certain exports of such chemical mixtures. The comments
suggested that DEA only regulate exports of such mixtures to certain
specific countries of concern. Given the applicability of such solvents
for both cocaine and heroin processing, however, the geographic regions
of concern are extremely widespread. Additionally, DEA has concerns
that exports of solvent chemical mixtures can be subject to re-
exportation from destination countries. DEA believes that such exports
of chemical mixtures should not be exempted since exports of these
chemical mixtures could have significant potential for diversion.
Therefore, these chemical mixtures, unless otherwise exempt, are
subject to the export and other CSA chemical regulatory requirements.
One commenter expressed concerns regarding the regulatory language
found in 21 CFR 1310.08(l) stating that, ``Domestic and import
transactions in chemical mixtures that contain acetone, ethyl ether, 2-
butanone, or toluene unless regulated because of being formulated with
another listed chemical above the concentration limit'' shall be
excluded transactions. The commenter stated that the regulatory
language does not make it clear that this exemption applies if the
mixture contains more than one of these chemicals (i.e. contains two or
more of the following: acetone, ethyl ether, 2-butanone or toluene).
The commenter expressed concerns that enforcement officials may deem
chemical mixtures containing more than ``one'' of these solvents as
regulated if the total quantity exceeded the List II concentration
limits. DEA agrees. Therefore, DEA is modifying 21 CFR 1310.08(l) to
read, ``Domestic and import transactions in chemical mixtures that
contain acetone, ethyl ether, 2-butanone, and/or toluene, unless
regulated because of being formulated with other List I or List II
chemical(s) above the concentration limit'' shall be excluded.
Clarification of Concentration Limits
As DEA stated in its Final Rule establishing concentration limits
for the vast majority of chemical mixtures (69 FR 74957, December 15,
2004), and
[[Page 10927]]
codified at 21 CFR 1310.14(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 from specified
provisions set forth in that section. The concentration limit is set at
35 percent (by weight or volume) for the cumulative amount of acetone,
methyl ethyl ketone (MEK), methyl isobutyl ketone (MIBK), toluene, and
ethyl ether. Therefore, the table in 21 CFR 1310.14(c) specifies that
for exports, the limit applies to the specific chemical or any
combination of acetone, ethyl ether, 2-butanone, methyl isobutyl
ketone, and toluene, if present in the mixture by summing the
concentrations for each chemical. For example, an export involving a
chemical mixture containing 20 percent acetone and 20 percent ethyl
ether would not be exempt because the cumulative total of 40 percent
exceeds the 35 percent concentration limit.
Final Action Taken in This Rulemaking
After considering all comments, DEA has decided to exempt domestic
and import transactions in chemical mixtures that contain acetone,
ethyl ether, 2-butanone, and/or toluene under 21 CFR 1310.08 pursuant
to 21 U.S.C. 802(39)(A)(iii) because regulation of such transactions
has been determined to be unnecessary for the enforcement of the CSA.
DEA determined that there is not a significant risk of domestic
diversion for these chemical mixtures.
Specific Requirements That Will Apply to Regulated Chemical Mixtures
Containing List II Chemicals Upon Publication of This Final Rule
The above exemption only exempts such chemical mixtures from the
domestic recordkeeping and import notification requirements. All other
CSA chemical regulatory provisions, as specified in detail in the
December 15, 2004 rule [69 FR 74957; corrected at 70 FR 294, January 4,
2005], shall apply.
III. Exemption Authority
The CSA authorizes DEA, pursuant to 21 U.S.C. 802(39)(A)(iii), to
remove certain transactions in listed chemicals from the definition of
a regulated transaction that are unnecessary for enforcement of the
CSA. Based on comments to the Federal Register proposed rule
``Exemption of Chemical Mixtures'' (63 FR 49506, September 16, 1998),
DEA identified certain transactions in mixtures of acetone, ethyl
ether, 2-butanone, and toluene that are unlikely sources for diversion.
DEA was informed that tens of thousands of domestic transactions in
these chemical mixtures occur annually. DEA determined that the
regulation of domestic and import transactions in mixtures containing
the chemicals acetone, ethyl ether, 2-butanone, and toluene were
unnecessary for enforcement of the CSA and should be removed from the
definition of a regulated transaction.
Since the NPRM to this rulemaking did not discuss this exemption,
the public did not have the opportunity to comment on the exclusion of
these transactions from the definition of a regulated transaction.
However, to avoid unnecessary burdens on affected companies during
the pendency of proceedings in this matter, DEA decided to include as
part of its December 15, 2004, Final Rule an interim rule, with request
for comment, removing these transactions from the definition of a
regulated transaction. Now that DEA has had the opportunity to solicit
and review comments, the exemption is being finalized in this rule.
IV. Regulatory Certifications
Regulatory Flexibility Act
DEA has become aware that a substantial number of chemical mixtures
that are not useful to traffickers could potentially be regulated if
the chemical mixtures that are subject to this rulemaking were not
excluded from certain regulatory requirements. DEA determined that the
regulation of these chemical mixtures is not necessary for enforcement
of the CSA. Therefore, DEA decided to exempt these chemical mixtures
from regulatory controls by exemption of certain types of transactions.
DEA notes that the List II solvent chemicals acetone, ethyl ether,
2-butanone, and toluene contribute to the largest number of potentially
regulated chemical mixtures of List II chemicals. To limit the number
of potentially regulated chemical mixtures to those necessary for
enforcement of the CSA, DEA decided to define all domestic and import
transactions of mixtures in these List II solvent chemicals as exempt
transactions. This exemption applies to all persons that handle these
chemical mixtures and not only to those who are represented in the
comments. DEA previously implemented this exemption and is finalizing
the exemption in this rulemaking.
In accordance with the Regulatory Flexibility Act (5 U.S.C.
605(b)), the Deputy Administrator has reviewed this regulation and by
approving it certifies that this regulation will not have a significant
economic impact upon a substantial number of small entities.
Executive Order 12866
This regulation has been drafted and reviewed in accordance with
Executive Order 12866, Section 1(b), Principles of Regulation. DEA has
determined that this rule is a ``significant regulatory action'' under
Executive Order 12866, Section 3(f), Regulatory Planning and Review,
and accordingly this rule has been reviewed by the Office of Management
and Budget. This rule finalizes an exemption for domestic and import
transactions involving the List II chemicals acetone, ethyl ether, 2-
butanone, and toluene.
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.
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
$118,000,000 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.
Congressional Review Act
This rule is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act). 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.
Paperwork Reduction Act
This rulemaking finalizes an exemption provision which reduced the
paperwork burden on handlers of acetone, ethyl ether, 2-butanone and
toluene. By exempting domestic and import transactions involving
chemical mixtures containing these List II chemicals DEA is not
subjecting these
[[Page 10928]]
transactions to CSA recordkeeping and reporting requirements. Domestic
and import transactions involving chemical mixtures containing acetone,
ethyl ether, 2-butanone and toluene are not subject to the following
information collections: DEA information collection 1117-0023: Import/
Export Declaration for List I and List II Chemicals [imports only]; and
DEA information collection 1117-0029: Annual Reporting Requirement for
Manufacturers of Listed Chemicals.
List of Subjects In 21 CFR Part 1310
Drug traffic control, List I and List II chemicals, Reporting and
Recordkeeping requirements.
0
For the reasons set out above, 21 CFR part 1310 is amended to read as
follows:
PART 1310--[AMENDED]
0
1. The authority citation for part 1310 continues to read as follows:
Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.
0
2. Section 1310.08 is amended by revising paragraph (l) to read as
follows:
Sec. 1310.08 Excluded Transactions.
* * * * *
(l) Domestic and import transactions in chemical mixtures that
contain acetone, ethyl ether, 2-butanone, and/or toluene, unless
regulated because of being formulated with other List I or List II
chemical(s) above the concentration limit.
Dated: March 1, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-4314 Filed 3-9-07; 8:45 am]
BILLING CODE 4410-09-P