DEA Proposes Exemption for Large Transactions in Gamma Butyrolactone (GBL)

Date: Dec 18, 2001

Synopsis: The Drug Enforcement Administration (DEA) recently proposed to exempt large, single-container transactions in GBL from applicable record-keeping requirements once the regulation becomes final. However, handlers of such GBL transactions will still be required to register with the DEA.

Details[i]: On February 18, 2000, Congress enacted the Date-Rape Drug Prohibition Act, outlawing gamma hydroxybutyric acid (GHB), popularly known as the “date-rape drug.” This Act gave DEA the authority to regulate gamma-butyrolactone (GBL), a precursor chemical that can be synthesized into GHB.[ii]  On April 24, 2000, DEA published a Final Rule, making GBL a List I chemical. Those who manufacture, distribute, import, and export a List I chemical such as GBL must register annually with DEA and maintain records of all regulated transactions.[iii]  Due to the fact that the Final Rule did not establish a GBL threshold, all transactions involving GBL are currently “regulated transactions.”

On October 24, 2001, DEA proposed an exemption from the definition of a “regulated transaction” for domestic, export, and import GBL transactions of 16,000 kilograms (about 16 tons) or more in a single container.[iv]  The exemption is intended to help minimize the potential impact of GBL regulations on legitimate industry, while preventing diversion.[v]  If finalized, the proposal will exempt handlers oflarge, single-container GBL shipments from recordkeeping requirements for suchtransactions.  However, handlers of such GBL transactions will still be requiredto register with the DEA and record all other transactions.

GBL has legitimate uses, for example, as an industrial cleaner.  DEA has found that most GBL intended forlegitimate use is transported in large quantities in single containers.[vi]  Conversely, the most DEA-documented diversion orattempted diversion of GBL occurs with containers ranging from 500-grams to 55-gallons. [vii]  Thus, by exempting large,single-container quantities of GBL, DEA hopes to remove regulatory restrictions fromlegitimate GBL handlers, while not providing a loophole for those seeking to divert thechemical for illegal use.[viii] 

For all other transactions in GBL, DEA proposes formalizing thecurrent “zero kilogram” threshold.[ix]  If finalized, all transactions in GBL (other thanthe large, single-container transactions subject to the exemption) will continue to besubject to the registration and recordkeeping requirements outlined in 21 C.F.R. Parts1309, 1310, and 1313. 

Comments on the proposal may be submittedto DEA through December 24, 2001.  Theexemption does not go into effect until it is finally approved by DEA.  Until that time, all GBL transactions areregulated.

For more information, contact DouglasJ. Behr at (202) 434-4213 or behr@khlaw.com.

[i] This article is not intended to provide legal advice and is only a discussion of the DEA’s proposed threshold and exemption for GBL.  If you manufacture, distribute, import, or export GBL, you may have to comply with federal and state regulations and should seek legal advice.

[ii] Date-Rape Drug Prohibition Act, Pub. L. No. 106-172, 114 Stat. 7 (2000) (codified as amended at 21 U.S.C. §§ 801-971 (2000)).

[iii] 65 Fed. Reg. 21,645 (2000); see also Federal Regulations Affecting Gamma Butyrolactone (GBL), on this website.

[iv] 66 Fed. Reg. 53,748 (2001).

[v] Id.

[vi] Id.

[vii] Id.

[viii] Id.