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July 18, 2002

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For final rule see: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2002_register&docid=02-23878-filed

BZP and TFMPP: DEA Notice of Intent to Schedule

[Federal Register: July 18, 2002 (Volume 67, Number 138)]
[Proposed Rules]               
[Page 47341-47343]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jy02-23]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA-226 N]

 
Schedules of Controlled Substances: Temporary Placement of 
Benzylpiperazine and Trifluoromethylphenylpiperazine 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 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-
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 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 
below.

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

[[Page 47342]]

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 
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 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 
published.
    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 Certifications

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 
Reform.

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 
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 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 
follows:

    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.
* * * * *


[[Page 47343]]


    Dated: July 9, 2002.
John B. Brown, III,
Deputy Administrator.
[FR Doc. 02-17901 Filed 7-17-02; 8:45 am]
BILLING CODE 4410-09-M

 

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