[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),
[[Page 52875]]
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