[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