Rules - 2003
FR Doc 03-22684 [Federal Register: September 8, 2003
(Volume 68, Number 173)] [Proposed Rules]
From the Federal Register Online via GPO Access
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.
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.
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),
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
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 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:
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),
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,
[FR Doc. 03-22684 Filed 9-5-03; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).