Date="03/12/93" Citation="58 FR 13533" Group="legal" Type="RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION, JUSTICE" Subject="Schedules of Controlled Substances; Temporary Placement of Alpha-ethyl tryptamine Into Schedule I"

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 Schedules of Controlled Substances; Temporary Placement of Alpha- ethyltryptamine Into Schedule I AGENCY: Drug Enforcement Administration, Justice. ACTION: Final rule.

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 Schedules of Controlled Substances; Temporary Placement of Alpha- ethyltryptamine Into Schedule I AGENCY: Drug Enforcement Administration, Justice. ACTION: Final rule. + ------------------------------------------------------------ SUMMARY: The Administrator of the Drug Enforcement Administration (DEA) is issuing this final rule to temporarily place alpha- ethyltryptamine into Schedule I of the Controlled Substances Act (CSA) pursuant to the emergency scheduling provisions of the CSA (21 U.S.C. 811(h)). This action is based on the finding by the DEA Administrator that the placement of alpha-ethyltryptamine in Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. As a result of this rule, the criminal sanctions and regulatory controls of Schedule I substances under the CSA will be applicable to the manufacture, distribution, and possession of alpha-ethyltryptamine. EFFECTIVE DATE: March 12, 1993. FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-7183. SUPPLEMENTARY INFORMATION: The Comprehensive Crime Control Act of 1984 (Pub. L. 98-473), which was signed into law on October 12, 1984, amended section 201 of the Controlled Substances Act (CSA) (21 U.S.C. 811) to give the Attorney General the authority to temporarily place a substance into Schedule I of the CSA if he finds that such action is necessary to avoid an imminent hazard to the public safety. A substance may be temporarily scheduled under the emergency provision of the CSA if that substance is not listed in any other schedule under Section 202 of the CSA (21 U.S.C. 812) or if there is no approval or exemption in effect under 21 U.S.C. 355 of the Food, Drug, and Cosmetic Act for the substance. The Attorney General has delegated his authority under 21 U.S.C. 811 to the Administrator of DEA (28 CFR 0.100). A notice of intent to temporarily place alpha-ethyltryptamine into Schedule I of the CSA was published in the Federal Register on January 14, 1993 (58 FR 4370). The Administrator transmitted notice of his intention to temporarily place alpha-ethyltryptamine into Schedule I of the CSA to the Assistant Secretary for Health of the Department of Health and Human Services. In response to this notification, the Food and Drug Administration has advised DEA that there are no exemptions or approvals in effect under 21 U.S.C. 355 of the Food, Drug, and Cosmetic Act for alpha- ethyltryptamine and that the Department of Health and Human Services has no objection to DEA's intention to temporarily place alpha-ethyltryptamine into Schedule I of the CSA. In making a finding that placing a substance temporarily in Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety the Administrator is required to consider three of the eight factors set forth in section 201(c) of the CSA (21 U.S.C. 811(c)). These factors are as follows: (4) History and current pattern of abuse; (5) The scope, duration and significance of abuse; and (6) What, if any, risk there is to the public health. Alpha-ethyltryptamine has been classified as a central nervous system (CNS) stimulant as well as a tryptamine hallucinogen. Chemically it is ALPHA-ethyl-1H-indole-3-ethanamine or 3-(2-aminobutyl) indole. It is structurally similar to N,N-dimethyltryptamine (DMT) and N,N-diethyltryptamine (DET) both of which are hallucinogens controlled in Schedule I of the CSA. Available data indicate that alpha-ethyltryptamine produces some pharmacological effects qualitatively similar to those of other Schedule I hallucinogens. DEA first encountered alpha-ethyltryptamine in 1986 at a clandestine laboratory in Nevada. Several exhibits of alpha- ethyltryptamine have been analyzed by DEA and state forensic laboratories since 1989. Individuals in Colorado and Arizona have purchased several kilograms of this substance as the acetate salt from chemical supply companies and have distributed and sold quantities to individuals for the purpose of human consumption. Touted as an MDMA (3,4-methylenedioxymethamphetamine)-like substance, it has been trafficked as "TRIP" or "ET". Distribution and use have been primarily among high school and college-age individuals. In Arizona, the death of a 19-year-old female was attributed to acute alpha-ethyltryptamine toxicity. Illicit use has been documented in both Germany and Spain where two deaths have resulted from alpha-ethyltryptamine overdose. Alpha-ethyltryptamine acetate was marketed by the Upjohn Company in 1961 as an antidepressant under the trade name of Monase. After less than one year of marketing, Upjohn withdrew its New Drug Application when it became apparent that Monase administration was associated with the development of agranulocytosis. Recent scientific data also suggest that this substance may produce neurotoxicity similar to the neurotoxic effects produced by MDMA and PCA (para-chloroamphetamine). In light of its CNS stimulatory and hallucinogenic properties similar to those of DMT, DET and MDMA, its association with agranulocytosis and its possible neurotoxicity, the continued uncontrolled availability of alpha-ethyltryptamine poses an imminent hazard to public safety. In accordance with the provisions of section 201(h) of the CSA (21 U.S.C. 811(h)) and 28 CFR 0.100 the Administrator has considered the three factors required for a determination of whether temporarily scheduling alpha-ethyltryptamine under the CSA is necessary to avoid an imminent hazard to the public safety. Based on a consideration of these factors and other relevant information, the Administrator finds that placement of alpha- ethyltryptamine into Schedule I of the CSA on a temporary basis is necessary to avoid an imminent hazard to the public safety. The following regulations are effective with respect to alpha- ethyltryptamine on March 12, 1993, except for those individuals registered with DEA in accordance with part 1301 or part 1311 of title 21 of the Code of Federal Regulations, who currently possess alpha-ethyltryptamine may continue to do so pending DEA's receipt of an application for amended registration no later than April 12, 1993: 1. Registration. Any person who manufactures, distributes, delivers, imports or exports alpha-ethyltryptamine or who engages in research or conducts instructional activities with respect to alph-ethyltryptamine or who proposes to engage in such activities must be registered to conduct such activities in accordance with parts 1301 and 1311 of title 21 of the Code of Federal Regulations. 2. Security. Alpha-ethyltryptamine must be manufactured, distributed and stored in accordance with secsec1301.71-1301.76 of title 21 of the Code of Federal Regulations. 3. Labeling and Packaging. All labels and labeling for commercial containers of alpha-ethyltryptamine must comply with requirements of secsec1302.03-1302.05, 1302.07 and 1302.08 of title 21 of the Code of Federal Regulations. 4. Quotas. All persons required to obtain quotas for alpha- ethyltryptamine must submit application pursuant to secsec1303.12 and 1303.22 of title 21 of the Code of Federal Regulations. 5. Inventory. Every registrant required to keep records and who possesses any quantity of alpha-ethyltryptamine is required to take an inventory of all stocks of this substance on hand pursuant to secsec1304.11-1304.19 of title 21 of the Code of Federal Regulations. 6. Records. All registrants to keep records pursuant to secsec1304.21- 1304.27 of title 21 of the Code of Federal Regulations must do so regarding alpha-ethyltryptamine. 7. Reports. All registrants required to submit reports in accordance with secsec1304.34-1304.37 of title 21 of the Code of Federal Regulations shall do so regarding alpha-ethyltryptamine. 8. Order Forms. All registrants involved in the distribution of alpha-ethyltryptamine must comply with the order form requirements of secsec1305.01-1305.16 of title 21 of the Code of Federal Regulations. 9. Importation and Exportation. All importation and exportation of alpha-ethyltryptamine must be in compliance with part 1312 of title 21 of the Code of Federal Regulations. 10. Criminal Liability. Any activity with alpha-ethyltryptamine not authorized by, or in violation of, the CSA or the Controlled Substances Import and Export Act occurring on or after March 12, 1993 is unlawful. The Administrator of the DEA hereby certifies that the temporary placement of alpha-ethyltryptamine into Schedule I of the CSA will have no significant impact upon entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This action involves the temporary control of a substance with no currently approved medical use in the United States. The temporary scheduling of alpha-ethyltryptamine is not a major rule for the purposes of Executive Order (E.O.) 12291 of February 17, 1981. It has been determined that drug scheduling matters are not subject to review by the Office of Management and Budget (OMB) pursuant to the provisions of E.O. 12291. Accordingly, this proposed emergency scheduling action is not subject to provisions of E.O. 12778 which are contingent upon review by OMB. This regulation both responds to an emergency situation posing an imminent danger to the public safety, and is essential to a criminal law enforcement function of the United States. This action has been analyzed in accordance with the principles and criteria in E.O. 12291, and it has been determined that the temporary placement of alpha-ethyltryptamine into Schedule I of the CSA does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Narcotics, Prescription drugs, Reporting and Recordkeeping requirements. Under the authority vested in the Attorney General by section 201(h) of the CSA (21 U.S.C. 811(h)), and delegated to the Administrator of the DEA by Department of Justice regulations (28 CFR 0.100), the Administrator hereby amends 21 CFR part 1308 as follows: PART 1308-SCHEDULES OF CONTROLLED SUBSTANCES 1. The authority citation for 21 CFR part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871b, unless otherwise noted. 2. Section 1308.11 is amended by adding paragraph (g)(5) to read as follows: sec1308.11 Schedule I. * * * * * (g) * * * (5) alpha-ethyltryptamine, its optical isomers, salts and salts of isomers-7249. Some other names: etryptamine; ALPHA-ethyl-1H-indole-3-ethanamine; 3-(2-aminobutyl) indole. * * * * * Dated: March 8, 1993. Robert C. Bonner, Administrator of Drug Enforcement. [FR Doc. 93-5734 Filed 3-11-93; 8:45 am] BILLING CODE 4410-09-M