http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-1800.htm
[Federal Register: January 28, 2003 (Volume 68, Number 1 8) ]
[Proposed Rules]
[Page 4127-4130]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ja03-21]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[DEA-238N]
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.
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SUMMARY: The Deputy Administrator of the Drug Enforcement
Administration (DEA) is issuing this notice of intent to temporarily
place alpha-methyltryptamine (AMT) and 5-
[[Page 4128]]
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.
SUPPLEMENTARY INFORMATION:
Background
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-
[[Page 4129]]
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 Certifications
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.
[[Page 4130]]
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:
Authority: 21 U.S.C. 811, 812, 871b, unless otherwise noted.
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,
Deputy Administrator.
[FR Doc. 03-1800 Filed 1-27-03; 8:45 am]
BILLING CODE 4410-09-M
