[Federal Register Volume 68, Number 173 (Monday, September 8, 2003)]
[Proposed Rules]
[Pages 52872-52875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22684]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-247P]


Schedules of Controlled Substances: Placement of 2,5-Dimethoxy-4-
(n)-propylthiophenethylamine, N-Benzylpiperazine and 1-(3-
Trifluoromethylphenyl)piperazine Into Schedule I of the Controlled 
Substances Act

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Administrator of the Drug Enforcement Administration (DEA) 
is issuing this notice of proposed rulemaking to place 2,5-dimethoxy-4-
(n)-propylthiophenethylamine (2C-T-7), N-Benzylpiperazine (BZP), and 1-
(3-trifluoromethylphenyl)piperazine (TFMPP) into Schedule I of the 
Controlled Substances Act (CSA). This proposed action is based on data 
gathered and reviewed by the DEA. If finalized, this proposed action 
would continue to impose the criminal sanctions and regulatory controls 
of Schedule I substances under the CSA on the manufacture, 
distribution, and possession of 2C-T-7, BZP, and TFMPP.

DATES: Comments must be received on or before October 8, 2003.

ADDRESSES: Comments and objections should be submitted to the 
Administrator, Drug Enforcement Administration, Washington DC 20537, 
Attention: DEA Federal Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and 
Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, DC 20537, (202) 307-7183.

SUPPLEMENTARY INFORMATION: On September 20, 2002, the Deputy 
Administrator of the DEA published two final rules in the Federal 
Register amending Sec.  1308.11(g) of Title 21 of the Code of Federal 
Regulations to temporarily place 2C-T-7 (67 FR 59163), and BZP and 
TFMPP (67 FR 59161) into Schedule I of the CSA pursuant to the 
temporary scheduling provisions of 21 U.S.C. 811(h). These final rules, 
which became effective on the date of publication, were based on 
findings by the Deputy Administrator that the temporary scheduling of 
2C-T-7, BZP, and TFMPP was necessary to avoid an imminent hazard to the 
public safety. The CSA (21 U.S.C. 811(h)(2)) requires that the 
temporary scheduling of a substance expire at the end of one year from 
the date of issuance of the order. However, if proceedings to schedule 
a substance pursuant to 21 U.S.C. 811(a)(1) have been initiated and are 
pending, the temporary scheduling of a substance may be extended for up 
to six months. Under this provision, the temporary scheduling of 2C-T-
7, BZP, and TFMPP, which would expire on September 19, 2003, may be 
extended to March 19, 2004. This extension is being ordered by the DEA 
Administrator in a separate action.
    In accordance with 21 U.S.C. 811(b) of the CSA, DEA has gathered 
and reviewed the available information regarding the pharmacology, 
chemistry, trafficking, actual abuse, pattern of abuse, and the 
relative potential for abuse of 2C-T-7, BZP, and TFMPP. The 
Administrator has submitted these data to the Acting Assistant 
Secretary for Health, Department of Health and Human Services. In 
accordance with 21 U.S.C. 811(b), the Administrator also requested a 
scientific and medical evaluation and a scheduling recommendation for 
2C-T-7, BZP, and TFMPP from the Acting Assistant Secretary for Health. 
The Food and Drug Administration (FDA) has notified the 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, BZP, or TFMPP. A search of the 
scientific and medical literature revealed no indications of current 
medical use of 2C-T-7, BZP, or TFMPP in the United States.

2,5-Dimethoxy-4-(n)-propylthiophenethylamine

What is 2,5-dimethoxy-4-(n)-propylthiophenethylamine?

    2,5-dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7), a 
phenethylamine hallucinogen, 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 is a sulfur analogue of 2CB. Both substances have the 
structural features necessary for stimulant and/or hallucinogenic 
activity. Based on its structural similarity to 2CB, one would expect 
2C-T-7's pharmacological profile to be qualitatively similar to 2CB if 
evaluated in preclinical and clinical studies.
    2C-T-7 is being abused for its action on the central nervous system 
(CNS),

[[Page 52873]]

and for its ability to produce euphoria with 2CB-like hallucinations. 
2C-T-7 has not been approved for medical use in the United States by 
the FDA. The safety of this substance for use in humans has never been 
demonstrated.
    Drug discrimination studies in animals have indicated that 2C-T-7 
is a psychoactive substance capable of producing hallucinogenic-like 
discriminative stimulus effects (i.e., subjective effects). 2C-T-7's 
subjective effects were shown to share some commonality with LSD; it 
partially substituted for LSD up to doses that severely disrupted 
performance in rats trained to discriminate LSD (Committee on Problems 
on Drug Dependence, Drug Evaluation Committee, Personal Communication). 
Like 2CB, DOM, and DOB, 2C-T-7 displays affinity for central serotonin 
receptors. Radioligand binding assays showed that 2C-T-7 affinity for 
the 5-HT receptor system was selective. Self-reports indicate that the 
hallucinogenic effects of 2C-T-7 are comparable to those of 2CB and 
mescaline.

Why is 2C-T-7 Being Controlled?

    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 other controlled substances. 2C-T-7 made its appearance in the 
``rave'' scene in Wisconsin, Oakland, California, and the Atlanta, 
Georgia areas.
    The abuse of 2C-T-7 by young adults in the United States began to 
spread in the year 2000. Since that time, 2C-T-7 has been encountered 
by law enforcement agencies in Northern Wisconsin, Texas, Tennessee, 
Washington, Oklahoma, Atlanta, Georgia, and the San Francisco, 
California areas. DEA information shows that 2C-T-7 has been observed 
at local ``rave'' parties in California and part of the Southeastern 
United States.
    Information gathered by DEA also 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.
    An Internet company was identified as a source of 2C-T-7 being sold 
in the United States. The business was operated from the owner's 
residence. Law enforcement authorities in Tennessee made a controlled 
purchase of 2C-T-7 from this Internet company; 250 mg of 2C-T-7 was 
purchased for $150.00. The owner has been charged with the distribution 
of 2C-T-7 and other products. 2C-T-7 has been clandestinely produced in 
the United States. A clandestine laboratory, identified as the supplier 
of 2C-T-7 to this Internet company, was seized in 2002 by DEA in Las 
Vegas, Nevada. 2C-T-7 has been sold as ``Tweety-Bird Mescaline.'' It 
has also been found in combination with N,N-dipropyltryptamine (DPT).
    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's 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 occurred in April 2001 and resulted from the co-
abuse of 2C-T-7 with MDMA. One young man died in Tennessee while 
another man died in the state of Washington.

N-Benzylpiperazine and 1-(3-trifluoromethylphenyl)piperazine

What are N-Benzylpiperazine and 1-(3-trifluoromethylphenyl)piperazine?

    N-Benzylpiperazine (BZP) and 1-(3-trifluoromethylphenyl)piperazine 
(TFMPP) are piperazine derivatives. BZP was first synthesized as a 
potential antiparasitic agent. It was subsequently shown to possess 
amphetamine-like and some antidepressant activity, but was not 
developed for marketing. TFMPP is an industrial chemical and shares 
some pharmacological similarities with 3,4-
methylenedioxymethamphetamine (MDMA or Ecstasy). Both BZP and TFMPP are 
primarily used as chemical intermediates and have no accepted medical 
use in the United States. The safety of these piperazines for use in 
humans has never been demonstrated.
    The available evidence suggests that the pharmacological effects of 
BZP and TFMPP are substantially similar to amphetamine and MDMA, 
respectively. The abuse liability studies conducted by the Drug 
Evaluation Committee of the College on Problems of Drug Dependence 
indicate that rhesus monkeys consistently self-administer BZP and 
exhibit stimulant-like behavioral effects following BZP self-
administration sessions. BZP fully generalizes to amphetamine's 
discriminative stimulus in monkeys. TFMPP generalizes to MDMA's 
discriminative stimulus effects and serves as discriminative stimulus 
in rats. Serotonergic mechanisms mainly underlie the discriminative 
stimulus effects of TFMPP.
    Consistent with the above-mentioned animal studies, it has been 
shown that BZP is about 20 times more potent than amphetamine in 
producing stimulant-like subjective and cardiovascular effects in 
humans (Bye C, et al., Eur. J. Clin. Pharmacol. 6: 163-169, 1973). 
Similarly, Campbell and colleagues (Eur. J. Clin. Pharmacol. 6: 170-
176, 1973), using a double-blind clinical study involving 18 subjects 
with a history of amphetamine dependence, reported that the nature and 
the time-course of behavioral, autonomic and subjective effects 
following BZP administration are similar to those of amphetamine. BZP 
was found to be about 10 times more potent than amphetamine in this 
study.
    Self-reports suggest that the subjective effects of BZP are 
stimulant-like and TFMPP is an active hallucinogen. These reports 
collectively suggest that BZP has amphetamine-like subjective and 
reinforcing effects, while TFMPP might have MDMA-like subjective 
effects in humans. Similar to other classical hallucinogens, TFMPP also 
binds to serotonin receptors. TFMPP, similar to MDMA, has been shown to 
release 5-HT from central serotonergic neurons through uptake carrier-
dependent mechanism (Pettibone D and Williams M, Biochem. Pharmacol. 
33: 1531-1535, 1984; Auerbach SB, et al., Neuropharmacol. 30: 307-311, 
1991).

Why are BZP and TFMPP Being Controlled?

    The initial indication of the abuse of BZP and TFMPP appeared in 
late 1996. An individual in Santa Barbara, California, promoted the use 
and sale of these and other ring-substituted phenylpiperazines homologs 
(i.e., 3-chlorophenyl-piperazine and 4-methoxyphenylpiperazine) through 
the Internet.
    The abuse of BZP/TFMPP has been growing as evidenced by the 
increasing encounters by law enforcement agencies since the late 
1990's. BZP powder, or tablets containing BZP alone or in combination 
with TFMPP, have been

[[Page 52874]]

seized by federal and state/local law enforcement agencies in 21 states 
and Washington DC. Since 2000, there have been 77 cases involving 
seizures of BZP/TFMPP with total of over 33,000 tablets/capsules and 
752,000 grams of powder. Although both BZP and TFMPP have legitimate 
uses as chemical intermediates, they are being purchased illegally from 
Internet chemical supply houses. They are sold in powder or liquid form 
or formulated into tablets and sold on the Internet for human 
consumption. These substances are being promoted as legal alternatives 
to MDMA and sold as ``Ecstasy'' or as ``BZP'', ``A2'', ``legal E'', or 
``legal X''. Law enforcement data indicate that these piperazines are 
mainly encountered as tablets, with imprints of logos commonly seen on 
MDMA tablets.
    The available scientific evidence as discussed above suggests that 
BZP and TFMPP share substantial pharmacological similarities with the 
Schedule II controlled substance amphetamine and the Schedule I 
controlled substance MDMA, respectively. The risks to the public health 
associated with amphetamine and MDMA, both substances with high 
potential for abuse, are well known and documented. BZP is about 10 to 
20 times more potent than amphetamine in producing stimulant-like 
subjective, euphoric and cardiovascular effects in humans. TFMPP, 
similar to MDMA, produces hallucinogenic effects. BZP and TFMPP can 
alter sensory and judgment processes and thus can cause serious adverse 
health consequences for both the user and the general public. DEA is 
aware of several instances where BZP and TFMPP have been used in 
combination and sold as counterfeit MDMA, a Schedule I controlled 
substance. In 2001, a report from a university in Zurich, Switzerland 
details the death of a young female which was attributed to the 
combined use of BZP and MDMA. The above data show that the continued, 
uncontrolled tablet production, distribution and abuse of BZP and TFMPP 
pose an imminent hazard to the public safety. There are no recognized 
therapeutic uses of these substances in the United States.
    The Administrator, based on the information gathered and reviewed 
by her staff and after consideration of the factors in 21 U.S.C. 
811(c), believes that sufficient data exist to support the placement of 
2C-T-7, BZP, and TFMPP into Schedule I of the CSA pursuant to 21 U.S.C. 
811(a). The specific findings required pursuant to 21 U.S.C. 811 and 
812 for a substance to be placed into Schedule I are as follows:
    (1) The drug or other substance has a high potential for abuse.
    (2) The drug or other substance has no currently accepted medical 
use in treatment in the United States.
    (3) There is a lack of accepted safety for use of the drug or other 
substance under medical supervision.
    Before issuing a final rule in this matter, the DEA Administrator 
will take into consideration the scientific and medical evaluation and 
scheduling recommendation of the Department of Health and Human 
Services in accordance with 21 U.S.C. 811(b). The Administrator will 
also consider relevant comments from other concerned parties.
    Interested persons are invited to submit their comments, 
objections, or requests for a hearing in writing, with regard to this 
proposal. Requests for a hearing should state with particularity the 
issues concerning which the person desires to be heard. All 
correspondence regarding this matter should be submitted to the 
Administrator, Drug Enforcement Administration, Washington, DC 20537. 
In the event that comments, objections or requests for a hearing raise 
one or more questions that the Administrator finds warrants a hearing, 
the Administrator shall publish a notice in the Federal Register 
summarizing the issues to be heard and setting the time for the 
hearing.

What Is the Effect of This Proposed Rule?

    This proposed rule, if finalized, would continue to subject those 
who handle 2C-T-7, BZP, and TFMPP to the regulatory controls and 
administrative, civil and criminal sanctions applicable to the 
manufacture, distribution, dispensing, importing and exporting of a 
Schedule I controlled substance.

Regulatory Certification

Regulatory Flexibility Act

    The Administrator hereby certifies that this proposed 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 
permanently places 2C-T-7, BZP, and TFMPP 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 proposed rulemaking 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 proposed rulemaking 
will not have sufficient federalism implications to warrant the 
preparation of a Federalism Assessment.

Unfunded Mandates Reform Act

    This proposed rulemaking 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 proposed rulemaking 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.

    For the reasons set out above, 21 CFR part 1308 is proposed to be 
amended as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

    1. The authority citation for part 1308 continues to read as 
follows:

    Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted.

    2. Section 1308.11 is proposed to be amended by:
    a. Redesignating existing paragraphs (d)(6) through (d)(27) as 
paragraphs (d)(7) through (d)(28),
    b. Adding a new paragraph (d)(6),
    c. Redesignating existing paragraphs (d)(28) through (d)(31) as 
paragraphs (d)(30) through (d)(33),
    d. Adding a new paragraph (d)(29),

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    e. Redesignating existing paragraphs (f)(2) through (f)(7) as 
paragraphs (f)(3) through (f)(8),
    f. And adding a new paragraph (f)(2) to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *
    (6) 2,5-dimethoxy-4-(n)-propylthiophenethylamine (other name: 2C-T-
7)--7348.
    * * *
    (29) 1-(3-trifluoromethylphenyl)piperazine (other name: TFMPP)--
7494.
* * * * *
    (f) * * *
    (2) N-Benzylpiperazine (some other names: BZP, 1-
benzylpiperazine)--7493.
* * * * *

    Dated: September 2, 2003.
Karen P. Tandy,
Administrator.
[FR Doc. 03-22684 Filed 9-5-03; 8:45 am]
BILLING CODE 4410-09-P