[Federal Register: September 10, 2003 (Volume 68, Number 175)]
[Rules and Regulations]
[Page 53290-53292]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10se03-7]
[[Page 53290]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR PART 1310
[Docket No. DEA-203F]
RIN 1117-AA52
Establishment of a Threshold for Gamma-Butyrolactone
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Final rule.
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SUMMARY: On October 24, 2001, DEA published a Notice of Proposed
Rulemaking titled ``Establishment of a Threshold for Gamma-
Butyrolactone'' (66 FR 53746) that proposed a zero kilogram threshold
and the exemption of transactions of 16,000 kilograms (net weight) or
more in a single container. This final rule establishes a zero kilogram
threshold for domestic, export, and import transactions of gamma-
butyrolactone (GBL) and excludes from the definition of a ``regulated
transaction'' all transactions of 4,000 kilograms (net weight) or more
in a single container. The DEA is reducing the weight required for
exclusion from what was proposed in response to a comment that showed
that transactions of 4,000 kilograms or more in a single container are
not likely to be diverted.
EFFECTIVE DATE: This final rule is effective October 10, 2003.
FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug and
Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537.
SUPPLEMENTARY INFORMATION:
I. Background
Action Being Taken in This Rulemaking
This rulemaking amends Title 21 of the Code of Federal Regulations
(CFR) 1310.04(g)(1) by adding a new paragraph to establish that GBL is
not assigned a threshold. In addition, 21 CFR 1310.08 is being amended
by adding a new paragraph to identify as an ``excluded transaction,''
transactions in GBL of 4,000 kilograms (net weight) or more in a single
container. This rulemaking applies to import, export, and domestic
(including retail) transactions. All transactions in GBL, unless
defined in 21 CFR 1310.08, are regulated transactions. Persons who
handle GBL must be registered with DEA, even if their distributions are
excluded from the definition of a ``regulated transaction.'' Regulated
persons include manufacturers who distribute, distributors, importers,
and exporters of GBL.
Illicit Use of GBL
Law enforcement authorities have identified GBL in gamma-
hydroxybutyric acid (GHB) clandestine laboratories and documented its
use as a GHB precursor. GBL is a necessary chemical precursor in the
clandestine synthesis of GHB because, to date, no other chemical has
been substituted for GBL in this process. Congress recognized this and
controlled GBL as a List I chemical upon enactment of Pub. L. 106-172
on February 18, 2000.
GBL is a unique chemical precursor. It can be converted to GHB by a
simple chemical reaction or it can be ingested directly, without
running a chemical reaction. That is, the body efficiently converts GBL
to GHB when ingested. Because GBL is converted to GHB by the body's own
action, GBL is routinely substituted for GHB to obtain the same type of
intoxication. Congress recognized this and adopted in Pub. L. 106-172 a
new subparagraph to 21 U.S.C. 802(32), the section of the Controlled
Substances Act (CSA) that defines a ``controlled substance analogue.''
The subparagraph maintains that the placement of GBL, or any other
chemical, as a listed chemical does not preclude a finding that the
chemical is a controlled substance analogue. DEA recognizes this
concern of Congress that GBL is being used as a direct substitute for a
Schedule I controlled substance. Although GBL is a chemical commodity
when used by legitimate industry, diversion of GBL can be tantamount to
diversion of a Schedule I controlled substance when it is intended for
human consumption.
Steps Leading to This Rulemaking
GBL was placed in the CSA as a List I chemical effective February
18, 2000, by enactment of Pub. L. 106-172, the ``Hillory J. Farias and
Samantha Reid Date-Rape Drug Prohibition Act of 1999'' (65 FR 21645,
April 24, 2000). That law, however, did not establish a threshold.
Consequently, all transactions in GBL are regulated transactions as
described in 21 CFR 1300.02(b)(28) until publication of this final
rule.
The final rule titled, ``Placement of Gamma-Butyrolactone in List I
of the Controlled Substances Act (21 U.S.C. 802(34))'' was published in
the Federal Register on April 24, 2000 (65 FR 21645). It amended 21 CFR
1310.02(a) (List I chemicals) to reflect the status of GBL as a List I
chemical. For regulatory purposes, DEA had no discretion in taking this
action. Therefore, 21 CFR 1310.02(a) was amended as a final rule. Since
it was published as a final rule, a threshold was not established
because the process of notice and comment would have been circumvented.
A Notice of Request for Information was published in the Federal
Register on October 23, 1998, at 63 FR 56941. The Notice was published
in anticipation of GBL becoming a listed chemical. In response to that
Notice, DEA received information on how GBL is distributed. In a Notice
of Proposed Rulemaking, published in the Federal Register on October
24, 2001 (66 FR 53746), a zero threshold was proposed along with a
means to exclude large scale industrial-type transactions from the
definition of a ``regulated transaction.'' DEA learned of these large-
scale transactions by comment in response to the Notice of Request for
Information.
Thresholds and How They Are Used
Transactions involving listed chemicals that are not exempt by
statute may be removed from the definition of ``regulated transaction''
(21 U.S.C. 802(39)) if regulation of such transactions is determined to
be unnecessary for purposes of law enforcement. One option for doing so
includes the establishment of a quantity threshold under 21 U.S.C.
802(39)(A).
DEA determined that it is necessary for purposes of law enforcement
that no threshold be established for GBL. In the Notice of Proposed
Rulemaking (NPRM) published at 66 FR 53746, DEA gave reasons why no
threshold should be established. These included the small weights of
GBL diverted for production of GHB and the fact that GBL is substituted
directly, without chemical conversion, for GHB. No comments were
received objecting to a zero threshold. Therefore, 21 CFR 1310.04(g)(1)
is being modified to add a new paragraph to include GBL, thus
finalizing that no threshold is established. This means that all
transactions in GBL, except those defined at 21 CFR 1310.08(k), are
regulated transactions. If the transaction is considered a regulated
transaction, recordkeeping and reporting requirements as specified in
21 CFR Part 1310 apply.
Exclusions and How They Are Used
DEA is authorized to remove certain categories of transactions from
the definition of a ``regulated transaction.'' Under 21 U.S.C.
802(39)(A)(iii) the agency may, by regulation, exempt ``any category of
transaction or any category of transaction for a specific listed
chemical or chemicals specified by
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regulation of the Attorney General as excluded from this definition as
unnecessary for enforcement of this subchapter or subchapter II of this
chapter.'' DEA is amending 21 CFR 1310.08 to exclude from the
definition of a ``regulated transaction,'' transactions involving 4,000
kilograms (net weight) or more in a single container. This amendment is
in response to a comment to the NPRM and is different than what the DEA
originally proposed. Adopting the suggestion in the comment is expected
to give more comprehensive regulatory relief to industry without
significantly increasing the risk of diversion.
DEA would like to emphasize that the exclusion applies only to
transactions of one or more single containers holding 4,000 kilograms
(net weight) or more of GBL. That is, in multi-container shipments, it
is a regulated transaction if any container has less than 4,000
kilograms or if the 4,000 kilograms is reached only by combining the
weight of GBL in each container.
II. Comments
DEA received one comment in response to the Notice of Proposed
Rulemaking ``Establishment of a Threshold for Gamma-Butyrolactone''
published at 66 FR 53746. The comment generally supported the proposal
and offered comments on specific issues.
The comment informed DEA that some tank truck shipments of bulk
chemicals are made by single segmented compartments. The minimum weight
of GBL distributed by these bulk shipments is 9,000 pounds or 4,086
kilograms. Therefore, under the proposed exclusion of bulk
distributions of 16,000 kilograms (net weight), these 4,086 kilogram
shipments would be regulated. DEA was not aware of the lower minimum
bulk shipment at the time the exclusion was proposed. DEA determined
that this lower net weight for bulk shipments would not pose a greater
risk of diversion and, therefore, based on the comment received, is
providing an exclusion for domestic, import, and export distributions
of gamma-butyrolactone weighing 4,000 kilograms (net weight) or more in
a single container. This action will eliminate all industrial
distributions identified by DEA that are not at significant risk of
diversion.
The commenter requested clarification as to whether a DEA Form 486
will continue to be required for bulk export shipments. A DEA Form 486
is necessary only for exports involving regulated transactions. If the
transaction is excluded from the definition of a ``regulated
transaction'' pursuant to 21 CFR 1310.08, a DEA Form 486 is not
necessary. If the export does not meet the conditions in 21 CFR
1310.08, a DEA Form 486 is necessary.
The commenter requested clarification of the definition of ``non-
regulated transaction.'' A non-regulated transaction is specified in 21
CFR 1310.08 as an ``excluded transaction'' pursuant to 21 U.S.C.
802(39)(A)(iii). An excluded transaction is not subject to the
recordkeeping or reporting requirements of 21 U.S.C. 830(a) and (b)
except that 21 U.S.C. 830(b)(1)(C) applies to all regulated persons.
That is, all regulated persons are required to report any unusual or
excessive loss or disappearance of a listed chemical.
The definition of a ``regulated person'' is given at 21 U.S.C.
802(38) to include anyone who manufactures, distributes, imports, or
exports a listed chemical, or acts as a broker or trader for an
international transaction involving a listed chemical. Except for
persons acting as brokers or traders for an international transaction,
regulated persons handling any List I chemical are required to register
pursuant to 21 U.S.C. 822. This registration requirement also applies
to those regulated persons who are involved in only ``excluded
transactions.'' In the case of this final rule, persons who only
distribute 4,000 kilograms (net weight) or more of GBL in a single
container are not subject to recordkeeping and reporting requirements
but are required to register. A regulated person does not include
someone who receives a listed chemical and consumes it by making a
chemical mixture, as defined at 21 U.S.C. 802(40), or changes the
listed chemical into a non-listed chemical by means of a chemical
reaction.
Regulatory Flexibility and Small Business Concerns
This final rule will not have a significant economic impact on
small business. Pub. L. 106-172 amended the CSA to make GBL a List I
chemical effective February 18, 2000. Regulatory impact due to
registration requirements was addressed in the final rule ``Placement
of gamma-butyrolactone in List I of the Controlled Substances Act (21
U.S.C. 802(34))'' (65 FR 21645). In that final rule, DEA concluded that
making GBL a List I chemical would not have a significant economic
impact. That conclusion was based on an estimated number of new
registrants and that all distributions in GBL are regulated. This final
rule does not add new regulatory controls. In fact, it eliminates some
large-scale industrial transactions from the definition of ``regulated
transaction,'' thus, granting additional relief to industry. DEA
identified 4,000 kilograms as the minimum amount available by tank-
truck. DEA determined that clandestine operations will have difficulty
handling tank-truck shipments but will be able to divert self-contained
shipments of GBL, i.e., containers of 55-gallons or less. Therefore,
DEA is exempting tank-truck sized shipments (4,000 kilograms or more,
net weight) from the requirements of this regulation.
New 21 CFR 1310.04(g)(1)(v) and 1310.08(k) are being added in this
final rule. The designations of these new paragraphs are different than
what was originally proposed because the CFR has been modified since
the proposal was published.
In accordance with the Regulatory Flexibility Act (5 U.S.C.
605(b)), the 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 not a ``significant regulatory action''
under Executive Order 12866, Section 3(f), Regulatory Planning and
Review, and accordingly this rule 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 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 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.
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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 cost 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.
0
For the reasons set out above, 21 CFR part 1310 is amended to read as
follows:
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES
0
1. The authority citation for part 1310 continues to read as follows:
Authority: 21 U.S.C. 802, 830, 871(b).
0
2. Section 1310.04 is amended by adding a new paragraph (g)(1)(v), to
read as follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(g) * * *
(1) * * *
(v) gamma-Butyrolactone (Other names include: GBL; Dihydro-2(3H)-
furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid
lactone; gamma-hydroxybutyric acid lactone)
* * * * *
0
3. Section 1310.08 is amended by adding a new paragraph (k) to read as
follows:
Sec. 1310.08 Excluded transactions.
* * * * *
(k) Domestic, import, and export distributions of gamma-
butyrolactone weighing 4,000 kilograms (net weight) or more in a single
container.
Dated: September 2, 2003.
Karen P. Tandy,
Administrator.
[FR Doc. 03-22963 Filed 9-9-03; 8:45 am]
BILLING CODE 4410-09-P