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BZP and TFMPP: DEA
Notice of Intent
[Federal Register: July 18, 2002 (Volume 67, Number 138)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
Schedules of Controlled Substances: Temporary Placement of
Benzylpiperazine and Trifluoromethylphenylpiperazine into Schedule I
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of intent.
SUMMARY: The Deputy Administrator of the Drug Enforcement
Administration (DEA) is issuing this notice of intent to temporarily
place N-Benzylpiperazine (BZP) and 1-(3-trifluoromethylphenyl)
piperazine (TFMPP) 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 BZP and TFMPP 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 BZP and TFMPP.
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-
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 for up to six 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) its 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 Are BZJP TFMPP?
BZP and TFMPP are piperazine derivatives. BZP was first synthesized
in 1944 as a potential antiparasitic agent. DEA is not aware of
therapeutic applications for BZP or TFMPP. BZP and TFMPP have no
accepted medical use in treatment in the United States. The safety for
use of these two substances has not been determined. They are available
primarily as chemical intermediates in syntheses. The two substances
are similar in chemical structure and are often found and abused
together in tablets or powder form.
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). The information relevant to the three factors is summarized
21 U.S.C. 811(c)(4) Its History and Current Pattern of Abuse
Abuse of BZP was first reported in late 996 in California. BZP and
TFMPP are being encountered in several regions of the U.S. and their
abuse has spread rapidly from the states where they were initially
encountered. Over the past few years, in the United States, BZP and
TFMPP have increasingly been found in similar venues as the popular
club drug 3,4-methylenedioxymethamphetamine (MDMA, also known as
Ecstasy). BZP and TFMPP are also sold as MDMA and are targeted to the
youth population. The tablet form often bears imprints commonly seen on
MDMA tablets such as a fly, crown, heart, butterfly, or bull's head
logos in pink, tan, white, or green. BZP and TFMPP have also been found
in powder form or liquid form packaged in small convenience sizes sold
on the Internet. Illicit distributions occur through smuggling of bulk
powder through organizations with connections to overseas sources of
supply. The bulk powder is then processed into capsule, tablet, or pill
form and distributed through organized networks. These organizations
also distribute other controlled substances such as MDMA, 2C-B,
marijuana and anabolic steroids.
21 U.S.C. 811(c)(5) the Scope, Duration, and Significance of Abuse
The increasing abuse of BZP and TFMPP in the United States is
evidenced by increasing encounters by law enforcement agencies. DEA,
State and local enforcement agencies reported BZP and TFMPP in drug
exhibits seized in the states of California, Connecticut, Florida,
Illinois, Indiana, Iowa, Louisiana, Minnesota, Nevada, Texas, Virginia,
and Wisconsin. In the past year, thirty-one seizures were reported and
amounted to over 21,000 tablets and 1000 pounds of powder. BZP asnd
TFMPP are being promoted as legal alternatives to MDMA. They are often
sold as ``Ecstasy'', or as ``BZP'', ``A2'', ``legal E'' or
``legal X''. BZP and TFMPP, with their easy availability and their so-
called legal status, are becoming drugs of abuse in the United States.
21 U.S.C. 811(c)(6) What If Any, Risk There Is To the Public Health
As with amphetamine and MDMA, the effects of BZP are stimulant-like
and those of TFMPP are hallucinogen-like. The risks to the public
health associated with MDMA and amphetamine, both substances with high
potential for abuse, are well known and documented. BZP acts as a
stimulant similar in effect to MDMA or amphetamine, producing euphoria
and inducing cardiovascular effects in humans, including increased
heart rate, systolic blood pressure and pulse rate. TFMPP, at
approximately 100 mg. produces hallucinogenic effects similar to those
produced by MDMA. TFMPP is a serotonin releasing agent and binds to
serotonin receptors in the brain. In 2001, a report from University in
Zurich, Switzerland details the death of a young female which was
attributed to the combined use of benxypiperazine 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.
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 BZP and TFMPP indicate that they have a high
potential for abuse, no currently accepted medical use in treatment in
the United States and are not safe for use under medical supervision.
What Is the Role of the Assistant Secretary for Health in the Temporary
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 BZP and TFMPP 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 BZP or TFMPP under the Federal Food, Drug and
Cosmetic Act, shall be taken into consideration before a final order is
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
all the available data and the three factors required for a
determination to temporarily schedule BZP and TFMPP under the CSA and
finds that placement of BZP and TFMPP into Schedule I of the CSA is
necessary to avoid an imminent hazard to the public safety.
When Will This Rule Take Effect?
Because the Deputy Administrator finds that it is necessary to
temporarily place BZP and TFMPP 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 of the Federal Register. BZP and
TFMPP will be subject to the regulatory controls and administrative,
civil and criminal sanctions applicable to the manufacture,
distribution, importing, exporting and possession of a Schedule I
controlled substance. 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 Flexibility Act
The Deputy Administrator hereby certifies that this rulemaking has
been drafted in accordance with the Regulatory Flexible 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 notice of
intent to temporarily place N-Benzylpiperazine (BZP) and 1-(3-
trifluoromethylphenyl)piperazine (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
Executive Order 13132 Federalism
This rule will not 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 E.O. 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 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 Record keeping
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 Deputy 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
Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.
2. Section 1308.11 is to be amended by adding paragraphs (g)(3) and
(4) to read as follows:
* * * * *
(g) * * *
(3) N-benzylpiperazine (some other names: BZP; 1-benzylpiperazine),
its optical isomers, salts and salts of isomers--7493.
(4) 1-(3-trifluoromethylphenyl) piperazine (other name: TFMPP), its
optical isomers, salts and salts of isomers--7494.
* * * * *
Dated: July 9, 2002.
John B. Brown, III,
[FR Doc. 02-17901 Filed 7-17-02; 8:45 am]
BILLING CODE 4410-09-M
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