DEA Establishes a Zero Threshold for Gamma Butyrolactone (GBL)

Date: Oct 15, 2003

Synopsis: On October 10, 2003, the Drug Enforcement Administration (DEA) established a zero kilogram threshold for domestic, export, and import transactions of GBL ("zero-threshold rule"), while exempting certain large single GBL transactions from DEA record-keeping requirements.1 The rule has no impact on mixtures that contain GBL.

Details:2 A common industrial cleaner, GBL was made a List I chemical several years ago because it is a precursor for the "date-rape" drug gamma-hydroxybutric (GHB), i.e., when taken orally, the human body converts GBL into GHB. 3 At that time, all parties who manufactured, distributed, imported, and/or exported GBL had to both: (1) register annually with DEA and (2) maintain records of all regulated GBL transactions. 4 More recently, DEA proposed formalizing this zero-threshold rule for GBL transactions, while exempting some large, single-container GBL transactions from record-keeping, but not DEA registration, requirements. 5

Specifically, on October 24, 2001, DEA proposed an exemption from the definition of a "regulated transaction" for domestic, export, and import of GBL in amounts of 16,000 kilograms (about 16 tons) or more in a single container. 6 However, based on comments that the DEA received following its proposal, the agency determined that GBL transactions of amounts as low as 4,000 kilograms (about 4 tons) were unlikely to be diverted for illegal drug use. 7 Thus, DEA lowered the exemption threshold to 4,000 kilograms or more for a single-container GBL transactions. This exemption means that companies or individuals handling single-container GBL transactions of 4,000 kilograms or more do not have to keep records of the transactions. 8 Nevertheless, the exempt parties still need to register annually with the DEA. In addition, handlers of less than 4,000 kilograms of GBL in a single container must continue to comply with both the registration and recordkeeping requirements outlined in 21 C.F.R. Parts 1309, 1310, and 1313.

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

1 See 21 C.F.R. Part 1310.

2 This article is not intended to provide legal advice and is only a discussion of the DEA's zero threshold standard. If you manufacture, distribute, import, or export GBL, you likely have to comply with federal and state regulations and should seek legal advice.

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

4 65 Fed. Reg. 21,645 (2000) (emphasis added); see also Federal Regulations Affecting Gamma Butyrolactone (GBL) and DEA Proposes Exemption for Large Transactions in Gamma Butyrolactone (GBL), on this website or available upon request.

5 66 Fed. Reg. 53,748 (2001).

6 Id..

7 Docket No. DEA-203F, RIN 1117-AA52, http://www.deadiversion.usdoj.gov/fed_regs/ rules/2003/fr0910.htm.

8 See 21 C.F.R. Part 1310.