[Federal Register Volume 67, Number 183 (Friday, September 20, 2002)]
[Rules and Regulations]
[Pages 59163-59165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23877]
[[Page 59163]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[DEA-225F]
Schedules of Controlled Substances: Temporary Placement of 2,5-
dimethoxy-4-(n)-propylthiophenethylamine Into Schedule I
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Final rule.
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SUMMARY: The Deputy Administrator of the Drug Enforcement
Administration (DEA) is issuing this final rule to temporarily place
2,5-dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) into Schedule I
of the Controlled Substances Act (CSA) pursuant to the temporary
scheduling provisions of the CSA. This final action is based on as
finding by the Deputy Administrator of the DEA that the placement of
2C-T-7 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 2C-T-7.
EFFECTIVE DATE: September 20, 2002.
FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and
Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, (202) 307-7183.
SUPPLEMENTARY INFORMATION:
Under What Authority Is 2C-T-7 Being Temporarily Scheduled?
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 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 temporarily7 scheduled under the emergency
provisions 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 Administrator of DEA (28 CFR 0.100). The Administrator has
redelegated this function to the Deputy Administrator, pursuant to 28
CFR 0.104.
A notice of intent to temporarily place 2C-T-& into Schedule I of
the CSA was published in the Federal Register on July 18, 2002 (67 FR
47343). The Deputy Administrator transmitted notice of his intention to
temporarily place 2C-T-7 into Schedule I of the CSA to the Assistant
Secretary for Health of the Department of Health and Human Services
(DHHS). 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 2C-T-7 and DHHS has no objection to DEA's intention to
temporarily place 2,5-dimethoxy-4-(n)-propylthiophenethylamine into
Schedule I of the CSA.
What Factors Were Considered in the Determination To Temporarily
Schedule 2,5-dimethoxy-4-(n)-propylthiophenethylamine?
As set forth under 21 U.S.C. 811(h), the Deputy Administrator has
considered the available data and the following three factors under the
CSA (21 U.S.C. 811(c)) that are required for a determination to
temporarily schedule a substance:
4. Its history and current pattern of abuse;
5. Scope, duration and significance of abuse; and
6. What, if any, risk there is to the public health.
Additionally, 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 2C-T-7 indicate that it has a high potential
for abuse, no currently accepted medical use in treatment in the United
States and is not safe for use under medical supervision.
What Is 2,5-dimethoxy-4-(n)-propylthiophenethylamine?
2,5-dimethoxy-4-(n)-propylth-phenethylamine (2C-T-7), a
phenethylamine, is structurally related to the Schedule I
phenethylamine 4-bromo-2,5-dimethoxyphenethylamine (2CB), and other
hallucinogens (e.g., 2,5-dimethoxy-4-methylamphetamine (DOM), and 1-(4-
bromo-2,5-dimethoxyphenyl)-2-aminopropane (DOB)) in Schedule I of the
CSA. 2C-T-7 has those structural features of phenethylamines which are
necessary for stimulant and/or hallucinogenic activity; 2C-T-7 is a
sulfur analogue of 2CB. Based on these structural features, 2C-T-7 is
likely to have a pharmacological profile similar to 2CB and other
Schedule I hallucinogens. The similarity in the effects of 2C-T-7 and
2CB has been supported by Shulgin and Shulgin (Pihkal: A Chemical Love
Story; pp. 569-570, 1991) and by ``self-reports'' on the Internet.
Shulgin and Shulgin (1991) reported that at an oral dose of 20 mg or 30
mg, 2C-T-7 produced visual hallucinations. They concluded that in terms
of being an acceptable hallucinogen, 2C-T-7 was comparable to 2CB and
mescaline. Self-reports on the Internet have described the
hallucinations resulting from the self-administration of 2C-T-7 as
being very 2CB-like, consisting of persistent multiple images, overlaid
patterns, and trails. The subjective effects of 2C-T-7 have also been
described as being similar to those of 2CB; mood lifting, sense of well
being, emotionality, volatility, increased appreciation of music, and
psychedelic ideation.
DEA is not aware of any approved therapeutic use of 2C-T-7 in the
United States. The safety of this substance for use in humans has never
been demonstrated.
Why Is 2C-T-7 Being Controlled?
The continued trafficking and abuse of 2C-T-7 poses an imminent
hazard to public safety. The abuse of stimulant/hallucinogenic
substances in popular all night dance parties (raves) and in other
venues has 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 MDMA and its analogues, collectively
known as Ecstasy, are the most popular drugs abused at these raves.
Their abuse has been associated with both acute and long-term public
health and safety problems. These raves have also become venues for the
trafficking and abuse of ``new non-controlled'' substances in place of
or in addition to ``Ecstasy.'' 2C-T-7 is one such substance.
Illicit use of 2C-T-7 was first reported in Germany in 1997. 2C-T-7
was placed under the control of German law on January 20, 1998. In
October of 1999, 2C-T-7 tablets were being sold in the Netherlands
under the trade name ``Blue Mystic''. Illicit use of 2C-T-7 was
reported in Sweden in January of 2000. Currently 2C-T-7 is controlled
under the Swedish law pertaining to goods which are dangerous to the
public. French Customs authorities reported seizing tablets in 2001
that contained 10 mg of 2C-T-7.
Abuse of 2C-T-7 in the United States was first reported in 1997; an
individual
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posted his experience associated with the oral ingestion of 20 mg of
2C-T-7 on the Lycaeum website on the Internet. In the year 2000, the
abuse of 2C-T-7 by young adults began to spread in the United States as
evidenced by widespread discussion on drug website forums and the sale
of the substance from an Internet company. The information being
discussed on these websites includes the route of administration,
recommended doses, and narratives from individuals describing their
experiences and effects after self-administering 2C-T-7.
Self-reported experiences and other information posted on these
websites indicate that 2C-T-7 is being abused orally (10-50 mg) or
intranasally; the oral route is the most common route of abuse. The
powder is being mixed in liquids or placed in gelatin capsules.
Information posted on these websites indicates that 2C-T-7 is being
taken alone or with other drugs, such as MDMA, ketamine, cannabis, N,N-
diisopropyl-5-methoxytryptamine (``Foxy Methoxy'') and N,N-
dipropyltryptamine (DPT).
Information gathered by DEA indicates that 2C-T-7 has been
purchased in powder form over the Internet and distributed as such. In
the United States, capsules containing 2C-T-7 powder also have been
encountered. In the Netherlands (``Blue Mystics'') and in Canada (``Red
Raspberry''), the bulk powder is being processed into tablets.
State and local law enforcement agencies reported 2C-T-7 exhibits
seized in the states of Texas and Wisconsin. In Wisconsin, two
unrelated exhibits were submitted to the Wisconsin State Crime
Laboratory for analysis; the first exhibit consisted of two clear
capsules containing 16 to 18 milligrams of white powder and two paper
packets. One packet contained 450 milligrams of tan powder and the
other paper packet contained 869 milligrams. The powder in these
exhibits was identified as 2C-T-7. These two capsules were sold to an
informant as ``Twenty-Bird Mescaline.'' The second exhibit analyzed by
the Wisconsin State Crime Laboratory was shown to be a mixture of 2C-T-
7 and N,N-dipropyltryptamine (DPT). 2C-T-7 has also appeared in illicit
traffic in Tennessee, Washington, and Oklahoma, as evidenced by the 2C-
T-7 related deaths in these states. To date, DEA has not identified a
clandestine laboratory synthesizing 2C-T-7.
2C-T-7 shares those structural similarities with 2CB and other
phenethylamines (i.e., DOB, and DOM) which makes it likely to produce
similar public health risks. Sensory distortion and impaired judgment
can lead to serious consequences for both the user and the general
public. 2C-T-7 can have lethal effects when abused alone or in
combination with other illicit drugs. To date, three deaths have been
associated with the abuse of 2C-T-7. The first death occurred in
Oklahoma during April of 2000; a young healthy male overdosed on 2C-T-7
following intranasal administration. The co-abuse of 2C-T-7 with MDMA
will pose a significant health risk if 2C-T-7 popularity increases in
the same venues as with MDMA. The co-abuse of 2C-T-7 with MDMA has
resulted in lethal effects. The other two 2C-T-7 related deaths
resulted from the co-abuse of 2C-T-7 with MDMA. They both occurred in
April of 2001. One young man died in Tennessee while another man died
in the state of Washington.
What Is the Effect of This Final Rule?
While the issuance of this final order, 2C-T-7 becomes subject to
regulatory controls and administrative, civil and criminal sanctions
applicable to the manufacture, distribution, dispensing, importing and
exporting of a Schedule I controlled substance.
1. Registration. Any person who manufactures, distributes,
dispenses, imports or exports 2C-T-7 or who engages in research or
conducts instructional activities with respect to 2C-T-7 or who
proposes to engage in such activities must submit an application for
Schedule I registration in accordance with part 1301 of Title 21 of the
Code of Federal Regulations (CFR) by October 21, 2002.
2. Security. 2C-T-7 is subject to Schedule I security requirements
and must be manufactured, distributed and stored in accordance with
Sec. Sec. 1301.71, 1301.72(a), (c), and (d), 1301.73, 1301.74,
1301.75(a) and (c) and 1301.76 of the Title 21 of the Code of Federal
Regulations.
3. Labeling and Packaging. All labels and labeling for commercial
containers of 2C-T-7 which are distributed on or after October 21,
2002. Shall comply with requirements of Sec. Sec. 1302.03-1302.07 of
Title 21 of the Code of Federal Regulations.
4. Quotas. Quotas for 2C-T-7 are established pursuant to part 1303
of Title 21 of the Code of Federal Regulations.
5. Inventory. Every registrant required to keep records and who
possesses any quantity of 2C-T-7 is required to keep inventory of all
stocks of this substance on hand pursuant to Sec. Sec. 1304.03,
1304.04 and 1304.11 of Title 21 of the Code of Federal Regulations.
Every registrant who desires registration in Schedule I for 2C-T-7
shall conduct an inventory of all stocks of 2C-T-7 on or before October
21, 2002.
6. Records. All registrants are required to keep records pursuant
to Sec. Sec. 1304.03, 1304.4 and Sec. Sec. 1304.21-1304.23 of Title
21 of the Code of Federal Regulations.
7. Reports. All registrants required to submit reports in
accordance with Sec. 1304.31 through Sec. 1304.33 of Title 21 of the
Code of Regulations shall do so regarding 2C-T-7.
8. Order Forms. All registrants involved in the distribution of 2C-
T-7 must comply with the order form requirements of part 1305 of Title
21 of the Code of Federal Regulations.
9. Importation and Exportation. All importation and exportation of
2C-T-7 shall be in compliance with part 1312 of Title 21 of the Code of
Federal Regulations.
10. Criminal Liability. Any activity with 2C-T-7 not authorized by,
or in violation of, the CSA or the Controlled Substances Import and
Export Act occurring on or after September 20, 2002 is unlawful.
Regulatory Certification
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
temporarily places 2C-T-7 into Schedule I of the CSA.
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 have 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
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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 Sec. 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 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 28 CFR 0.100, and redelegated to the Deputy
Administrator pursuant to 28 CFR 0.104, the Deputy 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:
Sec. 1308.11 Schedule I.
(g) * * *
(5) 2,5-dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7), its
optical isomers, salts and salts of isomers--7348.
* * * * *
Dated: September 6, 2002.
John B. Brown, III,
Deputy Administrator.
[FR Doc. 02-23877 Filed 9-19-02; 8:45 am]
BILLING CODE 4410-09-M