[Federal Register Volume 67, Number 139 (Friday, July 19, 2002)]
[Proposed Rules]
[Pages 47493-47494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17903]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[DEA-222A]
RIN 1117-AA64


Chemical Mixtures Containing gamma-Butyrolactone

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration (DEA) is soliciting 
information on chemical mixtures that contain the List I chemical 
gamma-butyrolactone (GBL). Specifically, DEA is interested in learning 
what products contain GBL, and what concentrations of GBL and other 
chemicals are used in their formulations. DEA is also interested in how 
chemical mixtures containing GBL are packaged, distributed, used, and 
their availability at the retail level. DEA is seeking this information 
to help determine whether there are chemical mixtures (as defined in 21 
U.S.C. 804(40)) containing GBL which should be exempt from the 
regulations governing listed chemicals, pursuant to 21 U.S.C. 
802(39)(A)(v). Exempt chemical mixtures are those formulations that 
contain any listed chemical, but are not subject to the regulatory 
controls of the Controlled Substances Act (CSA) that pertain to listed 
chemicals.
    On September 16, 1998, DEA published a notice of proposed 
rulemaking in the Federal Register (63 FR 49506) that proposed 
regulations to define exempt chemical mixtures. Because GBL was not 
then a listed chemical, regulations defining potential exempt chemical 
mixtures were not proposed. The information being requested in this 
advance notice of proposed rulemakig (ANPRM) will be used to help 
propose regulations to define what chemical mixtures containing GBL may 
be exempt.

DATES: Written comments must be submitted on or before September 17, 
2002.

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 Diversion Control, Drug 
Enforcement Administration, Washington, DC 20537; Telephone (202) 307-
7183.

SUPPLEMENTARY INFORMATION:   

What Is GBL and How Is It Used?

    GBL is gamma-butyrolactone, an important industrial chemical. It is 
also a List I chemical used in the illicit production of gamma-
hydroxybutric acid (GHB), a Schedule I controlled substance (21 U.S.C. 
812(c)). GBL is produced domestically in tens of thousands of tons per 
year. The legitimate manufacturers of GBL consume most of it for 
conversion into other industrial chemicals. The remaining amount is 
used in other industries with application to agriculture, electronics, 
textiles, coatings, and various other areas. Pure GBL has no household 
uses and is not available for sale at the retail level. However, it may 
be a component in some products sold at the retail level such as paint 
strippers.

How and Why Is GBL Regulated by DEA?

    GBL has been identified as the principal precursor used in the 
clandestine manufacture of the Schedule I controlled substance GHB. 
Public Law 106-172, the ``Hillory J. Farias and Samantha Reid Date-Rape 
Drug Prohibition Act of 1999,'' amended 21 U.S.C. 802(34) be 
designating GBL as a List I chemical. Since February 18, 2000, GBL has 
been subject to CSA regulatory controls. The CSA requires that all 
handlers of GBL must register as set forth in Title 21, Code of Federal 
Regulations (CFR), part 1309 and keep records and make reports as set 
forth in 21 CFR part 1310. Currently, only, GBL, but not its chemical 
mixtures, is subject to these controls. Until regulations which 
delineate criteria and procedures for exempting specific GBL-containing 
chemical mixtures are finalized, according to 21 U.S.C. 802(39)(4)(v), 
DEA has treated GBL-containing chemical mixtures as being exempt from 
the chemical regulatory requirements of the CSA.

Why Is DEA Interested in Learning About Chemical Mixtures 
Containing GBL?

    DEA is in the process of establishing regulations that define which 
chemical mixtures are exempt from CSA regulatory controls. The CSA 
defines the term ``chemical mixture'' as ``a combination of two or more 
chemical substances, at least one of which is not a List I chemical or 
a List II chemical, except that such term does not include any 
combination of a List I chemical or a List II chemical with another 
chemical that is present solely as an impurity.'' The CSA further 
allows exemption of chemical mixtures ``based on a finding that the 
mixture is formulated in such a way that it cannot be easily used in 
the illicit production of a controlled substance and that the listed 
chemical or chemicals contained in the mixture cannot be readily 
recovered.''
    A notice of proposed rule making (NPRM) regarding the exemption of 
chemical mixtures was published in the Federal Register on September 
16, 1998 (63 FR 49506). The NPRM proposed regulations to identify if a 
chemical mixture is automatically exempt from CSA regulatory controls. 
When the NPRM was published, GBL was not a regulated chemical. 
Therefore, regulations addressing the exemption of chemical mixtures 
containing GBL were not proposed.
    The NPRM proposed a concentration limit for each listed chemical. 
If a listed chemical is found in a chemical mixture at or below the 
concentration limit, the mixture is exempt. Also proposed were 
categories of exempt chemical mixtures and an application process. The 
application process is a means to exempt chemical mixtures not 
automatically exempted by regulation. These approaches were well 
received by the regulated industry and may be proposed to identify 
exempt chemical mixtures containing GBL.

What Is DEA Requesting in This ANPRM?

    To propose regulations in line with the above approaches, DEA is 
interested in learning about formulations that contain GBL. While some 
formulations containing GBL have been identified, DEA is not aware of 
the entire scope of mixtures containing GBL, including how they are 
used, traded, and their chemical composition. DEA invites all 
interested persons to provide the Administration with any information 
on chemical mixtures containing GBL. Both quantitative and qualitative 
information is requested. If the concentration of a chemical(s) varies 
in a formulation, DEA

[[Page 47494]]

is interested in the range of concentrations. Also of interest is how 
the mixtures are packaged, distributed, type of application, and the 
target market (e.g., type of industry, availability at retail, Internet 
sales). This information will be used to propose regulations to exempt 
those chemical mixtures that, according to 21 U.S.C. 802(39)(A)(v), are 
``formulated in such a way that it cannot be easily used in the illicit 
production of a controlled substance and that the listed chemical or 
chemicals contained in the mixture cannot be readily recovered.''
    Such information may be submitted to the address listed above and 
is requested by September 17, 2002. Information designated as 
confidential or proprietary will be treated accordingly. The release of 
confidential business information that is protected from disclosure 
under Exemption 4 of the Freedom of Information Act, 5 U.S.C. 
552(b)(4), is governed by section 310(c) of the CSA (21 U.S.C. 830(c)) 
and the Department of Justice procedures set forth in 28 CFR 16.7.

    Dated: July 1, 2002.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 02-17903 Filed 7-18-02; 8:45 am]
BILLING CODE 4410-09-M