Rules - 2003
FR Doc 03-1800
[Federal Register: January 28, 2003 (Volume 68, Number 18)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
Schedules of Controlled Substances: Temporary Placement of Alpha-methyltryptamine and 5-methoxy-N,N-diisopropyltryptamine Into Schedule I
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of intent.
SUMMARY: The Deputy Administrator of the Drug Enforcement Administration (DEA) is issuing this notice of intent to temporarily place alpha-methyltryptamine (AMT) and 5-
methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT) into Schedule I of the Controlled Substances Act (CSA) pursuant to the temporary scheduling provisions of the CSA. This intended action is based on a finding by the DEA Deputy Administrator that the placement of AMT and 5-MeO-DIPT into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. Finalization of this action will impose the criminal sanctions and regulatory controls of a Schedule I substance on the manufacture, distribution, and possession of AMT and 5-MeO-DIPT.
FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Telephone (202) 307-7183.
The Comprehensive Crime Control Act of 1984 (Pub. L. 98-473) amended section 201 of the CSA (21 U.S.C. 811) to give the Attorney General the authority to temporarily place a substance into Schedule I of the CSA for one year without regard to the requirements of 21 U.S.C. 811(b) if he finds that such action is necessary to avoid an imminent hazard to the public safety. The Attorney General may extend the temporary scheduling up to 6 months. 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 exemption or approval in effect under 21 U.S.C. 355 for the substance. The Attorney General has delegated his authority under 21 U.S.C. 811 to the Deputy Administrator of DEA (28 CFR 0.100).
Section 201(h)(4) of the CSA (21 U.S.C. 811(h)(4)) requires the Deputy Administrator to notify the Assistant Secretary for Health, delegate of the Secretary of Health and Human Services, of his intention to temporarily place a substance into Schedule I of the CSA. Comments submitted by the Assistant Secretary for Health in response to this notification, including whether there is an exemption or approval in effect for the substance in question under the Federal Food, Drug and Cosmetic Act, shall be taken into consideration before a final order is published.
In making a finding that places a substance temporarily into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Deputy 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-methyltryptamine and 5-methoxy-N,N-diisopropyltryptamine
Alpha-methyltryptamine (AMT) and 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT) are tryptamine (indoleethylamine) derivatives and share several similarities with the Schedule I tryptamine hallucinogens, alpha-ethyltryptamine (AET) and N,N-dimethyltryptamine (DMT), respectively. Several other tryptamines also produce hallucinogenic/stimulant effects and are controlled as Schedule I substances under the CSA (bufotenine, diethyltryptamine, psilocybin and psilocin). Although tryptamine itself appears to lack consistent hallucinogenic/stimulant effects, substitutions on the indole ring and the ethylamine side-chain of this molecule result in pharmacologically active substances (McKenna and Towers, J. Psychoactive Drugs, 16: 347-358, 1984).
The chemical structures of AMT and 5-MeO-DIPT possess the critical features necessary for hallucinogenic/stimulant activity. Thus, both AMT and 5-MeO-DIPT are likely to have a pharmacological profile substantially similar to other Schedule I tryptamine derivatives such as DMT and AET. In drug discrimination studies, both AMT and 5-MeO-DIPT substitute for 1-(2,5-dimethoxy-4-methylphenyl)-aminopropane (DOM), a phenethylamine-based hallucinogen in Schedule I of the CSA. The potencies of DOM-like discriminative stimulus effects of these and several other similar tryptamine derivatives correlate well with their hallucinogenic potencies in humans (Glennon et al., Eur. J. Pharmacol. 86:453-459, 1983).
AMT shares other pharmacological properties with Schedule I hallucinogens such as AET. AMT increases systolic and diastolic arterial blood pressures. The behavioral effects of orally administered AMT (20 mg) in humans are slow in onset, occurring after 3 to 4 hours and gradually subside after 12 to 24 hours, but may last up to 2 days in some subjects. The majority of the subjects report nervous tension, irritability, restlessness, inability to sleep, blurry vision, mydriasis and equate the effects of a 20 mg dose to those of 50 micrograms of lysergic acid diethylamide (LSD) (Hollister et al., J. Nervous Ment. Dis., 131: 428-434, 1960; Murphree et al., Clin. Pharmacol. Ther., 2: 722-726, 1961). AMT also produces hallucinations
and dextroamphetamine-like mood elevating effects.
5-MeO-DIPT also produces pharmacological effects similar to those of other Schedule I hallucinogens such as DMT. The synthesis and preliminary human psychopharmacology study on 5-MeO-DIPT was first published in 1981 (Shulgin and Carter, Comm. Psychopharmacol. 4: 363-369, 1981). 5-MeO-DIPT is an orally active hallucinogen. Following oral administration of 6-10 mg, 5-MeO-DIPT produces subjective effects with an onset at about 20-30 minutes, a peak at about 1-1.5 hours and a duration of about 3-6 hours. Subjects who have been administered 5-MeO-DIPT are talkative and disinhibited. 5-MeO-DIPT causes mydriasis. High doses of 5-MeO-DIPT produce nausea, jaw clenching, muscle tension and overt hallucinations with both auditory and visual distortions.
History and Current Pattern of Abuse
The popularity and use of hallucinogenic/stimulant substances at raves (all-night dance parties) and other social venues have been a major problem in Europe since the 1990s. In the past several years, this activity has spread to the United States. The Schedule I controlled substance 3,4-methylenedioxymethamphetamine (MDMA or Ecstasy) and its analogues are the most frequently abused drugs at these raves. Their abuse has been associated with both acute and long-term public health and safety problems. Raves have also become venues for the trafficking and abuse of new, non-controlled substances distributed as legal substitutes for, or in addition to, MDMA. 5-MeO-DIPT and AMT belong to such a group of substances.
Data gathered from published studies, supplemented by reports on Internet websites indicate that these are often administered orally at doses ranging from 15-40 mg for AMT and 6-20 mg for 5-MeO-DIPT. Other routes of administration include smoking and snorting. Data from law-enforcement officials indicate that 5-MeO-DIPT is often sold as "Foxy" or "Foxy Methoxy", while AMT has been sold as "Spirals" at least in one case. Both substances have been commonly encountered in tablet and capsule forms.
Scope, Duration and Significance of Abuse
According to forensic laboratory data, the first encounter of AMT and 5-MeO-
DIPT occurred in 1999. Since then, law enforcement officials in Arizona, California, Colorado, Delaware, Florida, Idaho, Illinois, Iowa, New Jersey, Oregon, Texas, Virginia, Washington, Wisconsin and the District or Columbia have encountered these substances. According to the Florida Department of Law Enforcement (FDLE), the abuse by teens and young adults of AMT and 5-MeO-DIPT is an emerging problem. There have been reports of abuse of AMT and 5-MeO-DIPT at clubs and raves in Arizona, California, Florida and New York. Many tryptamine-based substances are illicitly available from United States and foreign chemical companies and from individuals through the Internet. A gram of AMT or 5-MeO-DIPT as bulk powder costs less than $150 from illicit sources on the Internet. DEA is not aware of any legitimate medical or scientific use of AMT and 5-MeO-DIPT. There is recent evidence suggesting the attempted clandestine production of AMT and 5-MeO-DIPT in Nevada, Virginia and Washington, DC.
Public Health Risks
AMT and 5-MeO-DIPT share substantial chemical and pharmacological similarities with other Schedule I tryptamine-based hallucinogens in Schedule I of the CSA (AET and DMT). This makes it likely that these drugs cause similar health hazards. Tryptamine, the parent molecule of AMT and 5-MeO-DIPT, is known to produce convulsions and death in animals (Tedeschi et al., J. Pharmacol. Exp. Ther. 126:223-232, 1959). AMT and 5-MeO-DIPT, similar to other tryptaine- or phenethylamine-based hallucinogens, through the alteration of sensory perception and judgment can pose serious health risks to the user and the general public. Further, there have been several self-reports on Internet websites describing the reported abuse of these substances in combination with other controlled drugs, namely MDMA, marijuana, gamma hydroxybutyric acid (GHB) and 2,5-dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7). This practice of drug abuse involving combinations poses additional health risks to the users and the general public. Available information indicates that AMT and 5-MeO-DIPT lack any approved therapeutic use in the United States. The safety of these substances for use in humans has not been studied.
DEA has considered the three criteria for placing a substance into Schedule I of the CSA (21 U.S.C. 812). The data available and reviewed for AMT and 5-MeO-DIPT indicate that these substances each have a high potential for abuse, no currently accepted medical use in treatment in the United States and are not safe for use under medical supervision.
Role of the Assistant Secretary for Health in Temporary Scheduling
Section 201(h)(4) of the CSA (21 U.S.C. 811(h)(4)) requires the Deputy Administrator to notify the Assistant Secretary for Health, delegate of the Secretary of Health and Human Services, of his intention to temporarily place substances into Schedule I of the CSA. Comments submitted by the Assistant Secretary for Health in response to the notification regarding AMT and 5-MeO-DIPT, including whether there is an exemption or approval in effect for the substances in question under the Federal Food, Drug and Cosmetic Act, shall be taken into consideration before a final order is published.
Based on the above data, the continued uncontrolled distribution and abuse of AMT and 5-MeO-DIPT pose an imminent risk to the public safety. DEA is not aware of any recognized therapeutic uses of these substances in the United States.
In accordance with the provisions of section 201(h) of the CSA (21 U.S.C. 811(h)) and 28 CFR 0.100, the Deputy Administrator has considered the available data and the three factors required for a determination to temporarily schedule AMT and 5-MeO-DIPT in Schedule I of the CSA and finds that placement of AMT and 5-MeO-DIPT into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety.
Because the Deputy Administrator finds that it is necessary to temporarily place AMT and 5-MeO-DIPT into Schedule I to avoid an imminent hazard to the public safety, the final order, if issued, will be effective on the date of publication of the Federal Register. AMT and 5-MeO-DIPT will be subject to the regulatory controls and administrative, civil and criminal sanctions applicable to the manufacture, distribution, possession, importing and exporting of a Schedule I controlled substance under the CSA. Further, it is the intention of the Deputy Administrator to issue such a final order as soon as possible after the expiration of thirty days from the date of publication of this notice and the date that notification was transmitted to the Assistant Secretary for Health.
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this rulemaking has been drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation, and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small entities. This action provides a notice of intent to temporarily place AMT and 5-MeO-DIPT into Schedule I of the CSA. DEA is not aware of any legitimate uses of AMT and 5-MeO-DIPT in the United States.
Executive Order 12988
This regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
Executive Order 13132 Federalism
This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule will not has sufficient federalism implications to warrant the preparation of a Federalism Assessment.
Unfunded Mandates Reform Act
This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of 1995.
Small Business Regulatory Enforcement Fairness Act of 1996
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control, Narcotics, Prescription drugs, Reporting and record keeping 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 Deputy Administrator of the DEA by Department of Justice regulations (28 CFR 0.100), the Deputy Administrator hereby intends to order that 21 CFR part 1308 be amended as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
1. The authority citation for 21 CFR part 1308 continues to read as follows:
2. Section 1308.11 is to be amended by adding paragraph (g)(6) and (7) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(g) * * *
(6) Alpha-methyltryptamine (AMT), its isomers, salts and salts of isomers: 7432.
(7) 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT), its isomers, salts and salts of isomers: 7439.
* * * * *
Dated: January 10, 2003.
John B. Brown, III,
[FR Doc. 03-1800 Filed 1-27-03; 8:45 am]
BILLING CODE 4410-09-M
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).