02-17903. Chemical Mixtures Containing gamma-Butyrolactone

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Advance notice of proposed rulemaking.

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 [phone].

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 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.