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July 18, 2002

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Addendum Sept. 2002: 2C-T-7 Scheduled.

 

2-C-T-7: Intent to Schedule

[Federal Register: July 18, 2002 (Volume 67, Number 138)]
[Proposed Rules]               
[Page 47343-47345]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jy02-24]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA-227N]

 
Schedules of Controlled Substances: Temporary Placement of 2,5-
Dimethoxy-4-(n)-propylthiophenethylamine 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 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 intended action is 
based on a finding by the DEA Deputy Administrator that the placement 
of 2C-T-7 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 2C-T-7.

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:

What Is Temporary Scheduling?

    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 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 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 Deputy Administrator of DEA (28 
CFR 0.100).

What Criteria Must Be Considered in Determining Temporary Scheduling?

    In making a finding that placing 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.

What Is 2,5-Dimethoxy-4-(n)-propylthiophenethylamine?

    2,5-dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7), a 
phenethylamine, is structurally related to the Schedule I 
phenethylamine 4-bromo-2,5-dimethoxyphenethylamine (2C-B), 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 (Pikal: 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, emotionally, 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.

What Information Was Considered in Respect to Making the Finding of 
Imminent Hazard to the Public Health?

    DEA, as required by 21 U.S.C. 811(h)(3), considered the following 
three factors set forth in paragraphs (4), (5) and (6) of 21 U.S.C. 
811(c) in its decision to temporarily schedule 2C-T-7. The information 
relevant to the three factors is summarized below.

21 U.S.C. 811(c)(4) Its History and Current Pattern of Abuse

    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 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

[[Page 47344]]

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-disopropyl-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; whereas in the Netherlands (``Blue Mystics''), and in 
Canada (``Red Raspberry'') the bulk powder is being processed into 
tablets.

21 U.S.C. 811(c)(5) the Scope, Duration and Significance of Abuse

    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 ``Tweety-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. It is being sold under the ``street 
names'' Blue Mystic, T7, Beautiful, Tweety-Bird Mescaline or Tripstay. 
To date, DEA has not identified a clandestine laboratory synthesizing 
2C-T-7.

21 U.S.C. 811(c)(6) What, If Any, Risk There Is to Public Health

    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 Other Factors Were Taken Into Consideration?

    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 The Role of the Assistant Secretary for Health in Temporary 
Scheduling?

    As required by section 201(h)(4) of the CSA (21 U.S.C. 811(h)(4)), 
the Deputy Administrator has notified the Assistant Secretary for 
Health, delegate of the Secretary of Health and Human Services, of his 
intention to temporarily place 2C-T-7 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 2C-T-7 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 distribution and abuse of 
2C-T-7 poses an imminent risk to the public safety. There are no 
recognized therapeutic uses of this substance 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 2C-T-7 under the CSA and finds 
that placement of 2C-T-7 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 2C-T-7 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 in the Federal Register. 2C-T-7 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 2C-T-7 into Schedule I of the 
Controlled Substances Act.

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 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

[[Page 47345]]

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 Deputy 
Administrator of the DEA by Department of Justice regulations (28 CFR 
0.100), the Department 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)(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: July 9, 2002.
John B. Brown, III,
Deputy Administrator.
[FR Doc. 02-17902 Filed 7-17-02; 8:45 am]
BILLING CODE 4410-09-M

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