Fed Regist. 2010 Jun 29;75(124):37301-7.
This rulemaking finalizes a November 12, 2008, Notice of Proposed Rulemaking in which DEA proposed that chemical mixtures that are 70 percent or less gamma-butyrolactone (GBL), by weight or volume, be automatically exempt from regulatory controls under the Controlled Substances Act (CSA). DEA is seeking through this rulemaking to exempt only those chemical mixtures that do not represent a significant risk of diversion. This regulation makes GBL chemical mixtures, in concentrations greater than 70 percent, subject to List I chemical regulatory requirements of the CSA, except if exempted through an existing categorical exemption. DEA is taking this action because there is a serious threat to the public safety associated with the ease by which GBL is chemically converted to the schedule I controlled substance gamma-hydroxybutyric acid (GHB). DEA recognizes that concentration criteria alone cannot identify all mixtures that warrant exemption. As a result, DEA regulations provide for an application process by which manufacturers may obtain exemptions from CSA regulatory controls for those GBL chemical mixtures that are not automatically exempt under the concentration criteria.
本规则制定最终确定了2008年11月12日发布的拟议规则制定通知，其中美国缉毒局提议，按重量或体积计，γ-丁内酯（GBL）含量为70%或更低的化学混合物应自动免于《受控物质法》（CSA）的监管控制。美国缉毒局通过此次规则制定寻求仅豁免那些不存在重大转移风险的化学混合物。本规定使浓度高于70%的GBL化学混合物受CSA第一类化学品监管要求的约束，除非通过现有的类别豁免获得豁免。美国缉毒局采取这一行动是因为GBL可轻易化学转化为附表一受控物质γ-羟基丁酸（GHB），这对公共安全构成严重威胁。美国缉毒局认识到仅靠浓度标准无法识别所有应获豁免的混合物。因此，美国缉毒局的规定提供了一个申请程序，制造商可据此为那些根据浓度标准不能自动豁免的GBL化学混合物申请免于CSA监管控制。
