[Federal Register Volume 65, Number 79 (Monday, April 24, 2000)]
[Rules and Regulations]
[Pages 21645-21647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9988]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[DEA Number 199F]
RIN 1117-AA52


Placement of Gamma-Butyrolactone in List I of the Controlled 
Substances Act (21 U.S.C. 802(34))

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Final rule.

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SUMMARY: Public Law 106-172, signed into law on February 18, 2000, and 
known as the ``Hillory J. Farias and Samantha Reid Date-Rape Drug 
Prohibition Act of 1999,'' amends section 102(34) of the Controlled 
Substances Act as amended (CSA) by designating gamma-butyrolactone 
(GBL), the precursor to gamma-hydroxybutyric acid (GHB), as a List I 
chemical. Reflecting this change in stature, the Drug Enforcement 
Administration (DEA) is amending its regulation to reflect the status 
of GBL as a List I chemical subject to the requirements of the CSA and 
its regulations. Establishment of a threshold for GBL will be the 
subject of a separate rulemaking. Therefore, unless and until a 
threshold is established, any distribution of GBL is a regulated 
transaction as described by 21 CFR 1300.02(b)(28). All handlers of GBL 
must comply with the CSA regulatory requirements pertaining to List I 
chemicals as described in the body of this document.

FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug and 
Chemical Evaluation Section, Office of Diversion Control, Drug 
Enforcement Administration, Washington, DC 20537.

DATES: Effective: April 24, 2000.
    Registration application deadline: DEA must receive a properly 
completed DEA-510 registration application with fee from handlers of 
GBL on or before July 24, 2000.

SUPPLEMENTARY INFORMATION:

What Is DEA Doing and Whom Does It Effect?

    GBL is gamma-butyrolactone, the precursor used in the clandestine 
production of gamma-hydroxybutyric acid (GHB). This Final Rule deals 
solely with amending 21 CFR 1310.02(a) to reflect that GBL is a List I 
chemical as established by Public Law 106-172. Consequently any person 
who imports, exports, or distributes GBL must register with DEA and 
make required records and reports.

What Authority Does DEA Have To Do This?

    On February 18, 2000, Public Law 106-172 was enacted. This law 
requires the Attorney General (AG) to add gamma-hydroxybutyric acid 
(GHB) to Schedule I no later than April 18, 2000. Effective on February 
18, 2000, Congress also specifically designated the GHB precursor, 
gamma-butyrolactone (GBL) as a List I chemical.

Why Is This Being Published as a Final Rule?

    This publication amends 21 CFR 1310.02(a) to reflect the fact that 
Congress made GBL a List I chemical. For regulatory purposes, this 
action leaves DEA no discretion. Therefore, DEA is publishing this 
action as a Final Rule.

Why Was Control of GBL Necessary?

    Law enforcement authorities have identified GBL in many GHB 
clandestine laboratories and documented its use as a precursor in the 
clandestine synthesis of GHB. There are no chemical substitutes for GBL 
as a precursor in the clandestine synthesis of GHB. Congress recognized 
that control of GBL as a List I chemical is necessary to prevent 
diversion for use in the illicit production of GHB and made it a List I 
chemical. This Final Rule amends 21 CFR 1310.02(a) to reflect the fact 
that GBL is a List I chemical subject to the requirements of the CSA 
and its regulations.

Is GBL Subject to Any Other Controls Under the CSA?

    In addition to GBL functioning as a chemical precursor for the 
manufacture of GHB, it also produces psychoactive effects. If taken for 
human consumption, GBL and other chemicals, including 1,4-butanediol, 
are swiftly converted into GHB by the body. Abuse of these and other 
GHB-like substances is a significant law enforcement and public health 
problem. GBL and 1,4-butanediol are structurally and pharmacologically 
similar to GHB and are often substituted for GHB. Under certain 
circumstances they may satisfy the definition of a controlled substance 
analogue (21 U.S.C. 802(32)). Congress expressly contemplated this 
possibility by amending 21 U.S.C. 802(32) to state that the designation 
of GBL or any other chemical as a Listed chemical does not preclude a 
finding that the chemical is a controlled substance analogue and 
subject to the provisions of 21 U.S.C. 813.

Is There a Threshold for Transactions in GBL?

    Public Law 106-172 did not establish a threshold for regulated 
transactions involving GBL. Therefore, the DEA is reviewing available 
data, including that provided by commenters in response to the Federal 
Register publication ``Industrial Uses and Handling of Gamma-
butyrolactone; Solicitation of Information'' (63 FR 56941), regarding 
an appropriate threshold. This will be the subject of a separate 
rulemaking and will provide an opportunity for public comment. Until 
and unless a threshold is established, all covered transactions 
involving any amount of GBL are subject to the CSA regulatory 
requirements.
    Each regulated person who engages in a regulated transaction 
involving GBL must keep a record of the transaction and file reports 
under certain circumstances (21 CFR 1300.02(b)(28)). If a threshold is 
established for GBL, the recordkeeping and reporting requirements will 
only apply to transactions, including cumulative

[[Page 21646]]

transactions, which meet or exceed the threshold (21 CFR part 1310). 
These transactions also include the importation and exportation of GBL.

Are Chemical Mixtures Containing GBL Subject to Control?

    Chemical mixtures containing GBL will be treated the same as 
chemical mixtures containing any listed chemical. Currently, chemical 
mixtures containing listed chemicals are not subject to regulation. 
However, DEA is conducting a separate rulemaking to develop regulations 
governing the distribution of chemical mixtures that contain listed 
chemicals. A Notice of Proposed Rulemaking that addresses regulation of 
chemical mixtures containing listed chemicals was published in the 
Federal Register on September 16, 1998, (63 FR 49506). Because GBL was 
not a listed chemical at that time, the issue of GBL was not addressed. 
Therefore, DEA will publish a Notice of Proposed Rulemaking followed by 
a comment period to address the regulation of chemical mixtures 
containing GBL.

As a List I Chemical, What Specific Requirements Apply to GBL?

    Persons interested in handling GBL must comply with the following:
    1. Registration. Any person who manufactures or distributes GBL, or 
proposes to engage in the manufacture or distribution of GBL, shall 
obtain a registration pursuant to the CSA (21 U.S.C. 822). Regulations 
describing registration for List I handlers are set forth in 21 CFR 
part 1309.
    Separate registration is required for retail distribution, non-
retail distribution, importing, and exporting. Different locations 
operated by a single entity require separate registration if any 
location is involved with the distribution, import, or export of GBL. 
Effective Friday, February 18, 2000, any person distributing, 
importing, or exporting GBL became subject to the registration 
requirement under the CSA. DEA recognizes, however, that it is not 
possible for persons who distribute, import, or export GBL to 
immediately complete and submit an application for registration and for 
DEA to immediately issue registrations for those activities. Therefore, 
in order to allow continued legitimate commerce in GBL, DEA is 
establishing in 21 CFR 1310.09 a temporary exemption from the 
registration requirement for persons desiring to distribute, import, or 
export GBL, provided that DEA receives a properly completed application 
for registration to DEA on or before July 24, 2000. The temporary 
exemption for such persons will remain in effect until DEA takes final 
action on their application for registration. The temporary exemption 
applies solely to the registration requirement; all other chemical 
control requirements, including recordkeeping and reporting, remain in 
effect. Additionally, the temporary exemption does not suspend 
applicable federal criminal laws relating to GBL, nor does it supersede 
state or local laws or regulations. All handlers of GBL must comply 
with their state and local requirements in addition to the CSA 
regulatory controls.
    2. Records and Reports. The CSA (21 U.S.C. 830) requires that 
records are kept and reports are made that involve 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 transaction involving a List I chemical, 
provided the transaction is a regulated transaction. Because a 
threshold has not yet been established, a distribution, receipt, sale, 
importation, or exportation of GBL in any amount is a regulated 
transaction (21 CFR 1300.02(b)(28)).
    Each regulated bulk manufacturer of GBL shall submit manufacturing, 
inventory and use data on an annual basis (21 CFR 1310.05(d)). Bulk 
manufacturers that produce GBL solely for internal consumption 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.
    3. Import/Export. All imports/exports of GBL shall comply with the 
CSA (21 U.S.C. 957 and 971). Regulations for importation and 
exportation of List I chemicals are described in 21 CFR part 1313. 
Separate registration is necessary for each activity (21 CFR 1309.22).
    4. 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 GBL 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.

Regulatory Flexibility and Small Business Concerns

    Public Law 106-172 amended the CSA to make GBL a List I chemical 
effective February 18, 2000. DEA has no discretion in this matter. This 
Final Rule simply makes the necessary amendment to the regulations to 
bring them into conformance with the new requirement of the law. 
However, to insure the orderly continuation of legitimate commerce DEA 
is providing in the Final Rule temporary exemption from the 
registration requirement for persons handling GBL provided that DEA 
receives a properly completed application for registration on or before 
July 24, 2000.
    This Final Rule deals solely with amending 21 CFR 1310.02(a) to 
reflect the placement of GBL in List I by Public Law 106-172. It does 
not address a threshold; therefore, economic impact is based on 
registration. DEA will address the issue of a threshold and its impact 
in a separate Notice of Proposed Rulemaking followed by a comment 
period.
    Prior to enactment of Public Law 106-172, DEA had been aware of the 
possibility that GBL could become regulated under the CSA pending the 
scheduling of GHB in the CSA. Anticipating this, DEA sought information 
on the manufacturing, distribution, consumption, storage, disposal, and 
uses of GBL from legitimate handlers of GBL. DEA published a notice in 
the Federal Register on October 23, 1998, titled, ``Industrial Uses and 
Handling of Gamma-butyrolactone; Solicitation of Information'' (63 FR 
56941). The DEA received eight responses, one each from the three GBL 
manufacturers, one from a European association, and four from end-
users. Information on the extent of distributors and wholesalers of GBL 
was not provided.
    In the absence of specific information from the industry, DEA must 
estimate the number of companies distributing GBL. GBL is a common and 
widely used industrial solvent, therefore DEA is assuming that whoever 
distributes the common solvents acetone, toluene, or methyl ethyl 
ketone is likely to distribute GBL. DEA has identified approximately 
1,400 firms that distribute one or more of these chemicals.
    Provided the number of GBL handlers is 1,400, the initial total 
registration cost would be $833,000, based on the current new 
application fee of $595.00 for each

[[Page 21647]]

individual company. The total annual re-registration cost, based on the 
present renewal fee of $477.00 for each individual company, would be 
$667,800. It should be noted that DEA published a proposed rule in the 
Federal Register on December 1, 1999 (64 FR 67216) that proposed to 
reduce the new application fee to $326.00 and the renewal fee to 
$171.00 for each individual company, respectively. If finalized, these 
revised fees would reduce the total burden for initial registration and 
for annual re-registration to $456,400 and $239,400, respectively. In 
addition to the specific dollar cost, the registration requirement 
would require an annual reporting burden of 700 hours. This is based on 
the estimated one-half hour required to complete and submit an 
application for registration or re-registration. Therefore, in 
accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), the 
Deputy administrator has reviewed this application 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. The 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.

Administrative Procedure Act--Good Cause Exemption

    DEA finds that there is good cause to exempt this action from the 
notice and comment requirements of Section 553 of the Administrative 
Procedures Act on the grounds that notice and comment are unnecessary. 
Public Law 106-172 amended the CSA to make GBL a List I Chemical 
effective February 18, 2000. This action is a conforming amendment to 
21 CFR 1310.02(a) to make the regulations consistent with the 
requirements of the law. DEA has no discretion in this action and can 
not deviate from what Congress has enacted. Therefore, DEA is 
publishing this action as a Final Rule. To ameliorate this final 
action, DEA has included a temporary exemption from the registration 
requirement for persons handling GBL provided that DEA receives a 
properly completed application for registration on or before July 24, 
2000.

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 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.

Executive Order 13132

    This regulation will not have substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on distribution of power and responsibilities among the 
various levels of government. Therefore, in accordance with Executive 
Order 13132, it is determined that this rule does not have sufficient 
federalism implications to warrant the preparation of a Federalism 
Assessment.

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, Washington, DC 20537, 
Telephone (202) 307-7297.

List of Subjects in 21 CFR Part 1310

    Drug traffic control, Reporting and recordkeeping requirements.

    For reasons set out above, 21 CFR part 1310 is amended as follows:

PART 1310--[AMENDED]

    1. The authority citation for part 1310 continues to read as 
follows:

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

    2. Section 1310.02 is amended by adding a new paragraph (a)(24) to 
read as follows:


Sec. 1310.02  Substances covered

* * * * *
    (a) List I chemicals:
* * * * *

(24) gamma-Butyrolactone (Other names include: GBL; Dihydro-2       2011
 (3H)-furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic
 acid lactone; gamma-hydroxybutyric acid lactone)................
 


    3. Section 1310.09 is amended by adding a new paragraph (c) to read 
as follows:


Sec. 1310.09  Temporary exemption from registration

* * * * *
    (c) Each person required by section 302 of the act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export GBL is 
temporarily exempted from the registration requirement, provided that 
the DEA receives a proper application for registration on or before 
July 24, 2000. The exemption will remain in effect for each person who 
has made such application until the Administration has approved or 
denied that application. This exemption applies only to registration; 
all other chemical control requirements set forth in parts 1309, 1310, 
and 1313 of this chapter remain in full force and effect.

    Dated: April 14, 2000.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 00-9988 Filed 4-21-00; 8:45 am]
BILLING CODE 4410-09-M