[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]



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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