[Federal Register Volume 66, Number 206 (Wednesday, October 24, 2001)]
[Proposed Rules]
[Pages 53746-53749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26741]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[DEA-203P]
RIN 1117-AA52


Establishment of a Threshold for Gamma-Butyrolactone

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: DEA is proposing a zero kilogram threshold for domestic, 
export, and import transactions of gamma-butyrolactone (GBL), a List I 
chemical and the precursor to gamma-hydroxybutyric acid (GHB), a 
Schedule I controlled substance. DEA is concerned that GBL packaged in 
individual containers is convenient to traffickers and at risk of 
diversion. Therefore, DEA is proposing to regulate containers that can 
be easily transported, stored, and generally dealt with in clandestine 
settings.
    However, most GBL produced is used in captive markets or 
transported in large quantities in single containers. This material is 
less likely to be diverted. Therefore, this NPRM proposes to exempt 
from the definition of a ``regulated transaction'' all transactions of 
16,000 kilograms (net weight) or more in a single container.
    Pub. L. 106-172, the ``Hillory J. Farias and Samantha Reid Date-
Rape Prohibition Act of 1999,'' made GBL a List I chemical. 
Accordingly, DEA published a Final Rule, on April 24, 2000, (65 FR 
21645) conforming its regulations to this Act and making GBL a List I 
chemical. Because that Final Rule did not establish a threshold, all 
transactions in GBL are regulated transactions as described by 21 CFR 
1300.02(b)(28). The removal from the definition of a ``regulated 
transaction'' that DEA proposes in this NPRM for large (i.e., over 
16,000 kilograms) transactions of GBL will help minimize the potential 
impact of this rule on legitimate industry while preventing diversion.

DATES: Written comments must be received on or before December 24, 
2001.

ADDRESSES: Comments should be submitted to the Deputy Assistant 
Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, Attention: DEA Federal Register 
Representative/CCR.

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

SUPPLEMENTARY INFORMATION:

What Is GBL and Why Is It Being Regulated Under the Controlled 
Substances Act (CSA)?

    GBL is gamma-butyrolactone, the precursor used in the clandestine 
production of the Schedule I controlled substance gamma-hydroxybutyric 
acid (GHB). Since 1990, DEA has documented over 15,600 overdoses and 
law enforcement encounters in 46 states with GHB. DEA has documented 71 
GHB-related deaths. The GHB obtained in the vast majority of these 
encounters is by conversion of GBL.
    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 Prohibition Act of 1999'' (65 FR 21645, April 
24, 2000). That law, however, did not establish a threshold. As a 
result of the law not establishing a threshold, all transactions in GBL 
are regulated transactions as described in 21 CFR 1300.02(b)(28).
    DEA has identified the source for illicit GHB as being 
clandestinely synthesized from GBL. Law enforcement agencies have 
encountered GHB on at least 1,700 occasions, including more than 180 
clandestine laboratories and more than 750 seized and analyzed 
laboratory exhibits. GHB has only recently been scheduled in the CSA as

[[Page 53747]]

a controlled substance and GBL regulated as a List I chemical.
    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 could not be 
established at that time because that would circumvent the notice and 
comment process. Therefore, DEA is proposing to establish a threshold 
for GBL in this NPRM to allow opportunity for public comment.
    Law enforcement authorities have identified GBL in many 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), which is the section of the 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.

What Amounts of GBL Are Diverted for Conversion to GHB?

    DEA is aware that GBL is diverted in a variety of sizes to produce 
GHB. Unscrupulous suppliers, including those operating through the 
internet, supply different size containers to the public. GBL diverted 
from well-known and well-established reputable companies has also been 
identified. At least fifteen companies operated internet sites that 
sold GBL and potassium hydroxide or sodium hydroxide. The latter two 
chemicals are used to convert GBL to GHB in a simple one-step chemical 
reaction. These sites sold GBL either separately or in ``GHB kits.'' A 
kit contains premeasured amounts of GBL and potassium hydroxide or 
sodium hydroxide, as needed to produce GHB. GBL has been made available 
to anyone who desires it in quantities ranging from 75, 150, and 450 
grams, to 55-gallon drums. Most DEA documented diversion or attempted 
diversion of GBL is in 500-gram, three-kilogram, one-gallon, three-
gallon, five-gallon, and 55-gallon sizes. Usually, multiple containers 
are found at GHB manufacturing sites. However, because GBL has only 
recently been made a listed chemical and GHB a scheduled substance, law 
enforcement has only recently been involved with diversion of GBL and 
mostly concerned with large-scale diversion.

What Transactions of GBL Are of Concern?

    GBL is an industrial chemical. Most GBL produced is consumed by the 
producer or transported in large quantities. DEA is concerned that GBL 
packaged in smaller individual containers is convenient to traffickers 
and higher risk of diversion. DEA is proposing to regulate containers 
that can be easily transported, stored, and generally dealt with in 
clandestine settings.
    The largest size container identified by DEA, short of a tank-
truck, is a 55-gallon (500-pound) drum. This size, as well as smaller 
sizes (see above), have been marketed to the public, used for 
conversion to GHB, and encountered in clandestine GHB laboratories. 
Therefore, to address diversion of GBL in 55-gallon and smaller 
containers, DEA is proposing that no threshold be established. However, 
because DEA is concerned with these smaller size containers and because 
large-scale industrial distributions of GBL by tank-truck and rail car 
containers have not, and are not, likely to be diverted this proposal 
includes an exemption for large container industrial distributions.
    This notice proposes that large, single-container distributions of 
GBL are exempt from the definition of a regulated transaction. DEA 
identified approximately 16,330 kilograms as the smallest bulk size 
distribution in a single container. A tank-truck is used to transport 
that amount. Therefore, DEA is proposing that distributions of GBL in 
single container shipments of 16,000 kilograms (35,200 pounds) (net 
weight) or more be excluded from the definition of a regulated 
transaction for domestic, import and export distributions. According to 
this proposal, transactions involving multiple containers each holding 
less than 16,000 kilograms are regulated, even if the aggregate weight 
is over 16,000 kilograms.

Why Is DEA Proposing This Rulemaking?

    The purpose of this notice is to propose a zero threshold for 
distribution of GBL, to propose a regulatory exemption for large bulk 
transactions, and obtain comments on this approach. DEA is soliciting 
further information on the type and extent of transactions in GBL. This 
information is required to help minimize the potential impact on 
industry while maintaining necessary regulatory controls.

What Is a Threshold and Why Are Thresholds Used?

    Transactions involving listed chemicals that are not exempt by 
statute (e.g. certain transactions in chemical mixtures) 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. Two options for doing so include a 
categorical exemption under 21 U.S.C. 802(39)(A)(iii) or the 
establishment of a quality threshold under 21 U.S.C. 802(39)(A).
    The CSA provides that the Attorney General may establish a 
threshold amount for each listed chemical. A threshold amount is 
established to determine whether a receipt, sale, importation or 
exportation within a calendar month or cumulative transactions by an 
individual within a calendar month are considered regulated 
transactions. If the transaction is considered a regulated transaction, 
recordkeeping and reporting requirements as specified in 21 CFR part 
1310 apply.

Why Is DEA Proposing This Threshold?

    Because GBL is easily converted to GHB, GBL is desired by persons 
not experienced in chemistry and finds its way into both household and 
traditional clandestine laboratory settings. That is, GBL is converted 
to GHB for ``individual use'' and by traffickers for wider 
distribution. Therefore, the control of GBL is necessary for relatively 
small quantities of GBL used to make ``individual use'' amounts of GHB.

[[Page 53748]]

    DEA is proposing a zero threshold for domestic, import, and export 
transactions to capture all quantities of GBL that can be easily used 
in a clandestine laboratory. In addition, this chemical is efficiently 
converted to GHB when ingested. Therefore, the zero threshold is 
proposed to regulate distribution of a chemical that can be, and is, 
directly converted into and substituted for a Schedule I controlled 
substance.
    DEA identified GBL in quantities as small as 75 grams being sold 
unconcernedly to the public by unscrupulous persons. If a threshold 
above zero is established for GBL, DEA believes that individuals will 
obtain GBL at a quantity below the established threshold, not only from 
legitimate distributors, but also from businesses that will cater to 
this market.
    The DEA is aware that most businesses that manufacture and/or 
distribute GBL have recognized its abuse and attempted to prevent its 
diversion, even before the chemical became a regulated chemical. The 
GBL that is sold irresponsibly to the general public is not 
manufactured clandestinely. All GBL is produced by legitimate 
manufacturers. GBL diverted from legitimate and responsible companies 
has been identified at clandestine GHB laboratories and at sites where 
GBL is knowingly diverted. Chemical companies that are concerned about 
public safety still find it difficult to prevent diversion of their 
products. However, if records are kept for all transactions, and the 
buyer understands that the sale is reportable to DEA, persons who 
intend to use the chemical illegitimately will be discouraged from 
ordering.

What Is an Exemption and Why Are Exemptions Used?

    In addition to setting quantity-based thresholds, DEA is authorized 
to remove certain categories of transactions from the definition of 
``regulated transactions.'' Under 21 U.S.C. 802(39)(A)(ii) the agency 
may, by regulation, exempt ``any category of transaction of any 
category of transactions for a specific listed chemical or chemicals 
specified by regulation of the Attorney General as excluded from this 
definition as unnecessary for enforcement of this subchapter or 
subchapter II of this chapter.''

What Exemptions Is DEA Proposing and Why?

    DEA is proposing to exempt large single container distributions of 
GBL based on industry's response to an earlier solicitation of 
information. DEA published a request for information entitled 
``Industrial Uses and Handling of Gamma-butyrolactone; Solicitation of 
Information'' in the Federal Register on October 23, 1998 (63 FR 56941) 
in anticipation that GBL may become a regulated chemical. Interested 
persons supplied DEA with pertinent information. Of the eight 
respondents, three were manufacturers, one a European business 
association, and four were end-users. There was no response from 
distributors of GBL, except that the three manufacturers also 
distribute.
    Domestic manufacturers informed DEA that tens of thousands of tons 
are produced annually. Most GBL is consumed by the manufacturer or 
transported in net weight of tens of thousands of pounds. The smallest 
tank-truck size identified by DEA, from the response to the Federal 
Register request for information, is 16,330 kilograms (net weight). GBL 
shipped by tank-truck needs to be transferred to a holding container. 
This equipment implies shipment is made to an established industrial 
location having facilities able to handle large quantities of 
industrial chemicals. It is likely that the added difficulty, cost, 
equipment, and complexity in handling this type of large bulk shipment 
would deter diversion. Therefore, DEA is proposing to exempt shipments 
of 16,000 kilograms (35,200 pounds) (net weight) or more in a single 
container from the definition of a regulated transaction, pursuant to 
21 U.S.C. 802(39)(A)(iii).

What Alternatives Has DEA Considered, and Why Were They Not Chosen?

    As an alternative to the above exemption, DEA considered proposing 
a threshold of multiple quantity 55-gallon drums. However, DEA 
determined that while clandestine operations would have difficulty 
handling tank-truck shipments they will be able to divert smaller, 
self-contained receptacles of GBL, i.e., containers of 55-gallons or 
less. Accordingly, DEA declined to propose a threshold of multiple 
quantity 55-gallon drums.
    DEA also considered exempting smaller quantities of GBL, such as 
those below 75 grams. However, because these smaller quantities would 
be desirable to those who would manufacture ``individual use'' 
quantities of GHB, or consume the GBL without chemical conversion to 
GHB, DEA decided not to propose this exemption. Further, most 
legitimate GBL is distributed in larger quantities. Quantities of 75 
grams and less is restricted mostly to chemical clearinghouses that 
supply researchers. The amount of GBL distributed in these quantities 
is relatively small. The minimal regulatory relief from exemption of 
small quantity distributions in GBL, weighed against its diversion 
without fear of reprisal, convinced DEA not to propose small quantity 
exemptions.

Regulatory Certifications

Regulatory Flexibility, and Small Business Concerns

    This NPRM 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 were 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 NPRM does not add new 
regulatory controls. In fact, it proposes to eliminate some large-scale 
industrial transactions from the definition of ``regulated 
transaction,'' thus granting additional relief to industry. DEA 
identified approximately 16,330 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 proposing to exempt tank-truck sized 
shipments (16,000 kilograms or more, net weight) from the requirements 
of this regulation.
    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 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

[[Page 53749]]

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.

Paperwork Reduction Act

    This rulemaking imposes no recordkeeping or reporting requirements 
on registrants. No information collection request is necessary.

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.

Plain Language Instructions

    The DEA 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, Drug Enforcement Administration, Washington, DC 
20537, telephone (202) 307-7297.

List of Subjects in 21 CFR Part 1310

    Drug traffic control, List I and List II chemicals, reporting 
requirements.
    For the reasons set out above, 21 CFR part 1310 is proposed to be 
amended to read 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 1310.04(g)(1) is proposed to be amended by adding a new 
paragraph to read as follows:


Sec. 1310.04  Maintenance of records.

* * * * *
    (g) * * *
    (1) * * *
    (ii) Gamma-Butyrolactone (Other names include: GBL; Dihydro-2(3H)-
furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid 
lactone; gamma-hydroxybutyric acid lactone)
* * * * *
    3. Section 1310.08 is proposed to be amended by adding a new 
paragraph (j) to read as follows:


Sec. 1310.08  Excluded transactions.

* * * * *
    (j) Domestic, import, and export distributions of gamma-
butyrolactone weighing 16,000 kilograms (net weight) or more in a 
single container.

    Dated: October 16, 2001.
Asa Hutchinson,
Administrator.
[FR Doc. 01-26741 Filed 10-23-01; 8:45 am]
BILLING CODE 4410-09-M