[Federal Register Volume 68, Number 175 (Wednesday, September 10, 2003)]
[Rules and Regulations]
[Pages 53290-53292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22963]



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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