Rules - 2002
[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 2,5- Dimethoxy-4-(n)-propylthiophenethylamine 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 2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) 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 2C-T-7 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 2C-T-7.
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.
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 up to 6 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) 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 Is 2,5-Dimethoxy-4-(n)-propylthiophenethylamine?
2,5-dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7), a phenethylamine, is structurally related to the Schedule I phenethylamine 4-bromo-2,5-dimethoxyphenethylamine (2C-B), 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 has those structural features of phenethylamines which are necessary for stimulant and/or hallucinogenic activity; 2C-T-7 is a sulfur analogue of 2CB. Based on these structural features. 2C-T-7 is likely to have a pharmacological profile similar to 2CB and other Schedule I hallucinogens. The similarity in the effects of 2C-T-7 and 2CB has been supported by Shulgin and Shulgin (Pikal: A Chemical Love Story; pp. 569-570, 1991) and by "self-reports" on the Internet. Shulgin and Shulgin (1991) reported that at an oral dose of 20 mg or 30 mg, 2C-T-7 produced visual hallucinations. They concluded that in terms of being an acceptable hallucinogen, 2C-T-7 was comparable to 2CB and mescaline. Self-reports on the Internet have described the hallucinations resulting from the self-administration of 2C-T-7 as being very 2CB-like; consisting of persistent multiple images, overlaid patterns, and trails. The subjective effects of 2C-T-7 have also been described as being similar to those of 2CB; mood lifting, sense of well being, emotionally, volatility, increased appreciation of music, and psychedelic ideation.
DEA is not aware of any approved therapeutic use of 2C-T-7 in the United States. The safety of this substance for use in humans has never been demonstrated.
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) in its decision to temporarily schedule 2C-T-7. The information relevant to the three factors is summarized below.
21 U.S.C. 811(c)(4) Its History and Current Pattern of Abuse
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 "new non-controlled" substances in place of or in addition to "Ecstasy." 2C-T-7 is one such substance.
Illicit use of 2C-T-7 was first reported in Germany in 1997. 2C-T-7 was placed under the control of German law on January 20, 1998. In October of 1999, 2C-T-7 tablets were being sold in the Netherlands under the trade name "Blue Mystic". Illicit use of 2C-T-7 was reported in Sweden in January of 2000. Currently 2C-T-7 is controlled under the Swedish law pertaining to goods which are dangerous to the public. French Customs authorities reported seizing tablets in 2001 that contained 10 mg of 2C-T-7.
Abuse of 2C-T-7 in the United States was first reported in 1997; an individual posted his experience associated with the oral ingestion of 20 mg of 2C-T-7 on the Lycaeum website on the Internet. In the year 2000, the abuse of 2C-T-7 by young adults began to spread in the United States as evidenced by widespread discussion on drug website forums and the sale of the substance from an Internet company. The information being discussed on these websites includes the route of administration, recommended doses, and narratives from individuals describing their experiences and effects after self-administering 2C-T-7.
Self-reported experiences and other information posted on these websites indicate that 2C-T-7 is being abused orally (10-50 mg) or intranasally; the
oral route is the most common route of abuse. The powder is being mixed in liquids or placed in gelatin capsules. Information posted on these websites indicates that 2C-T-7 is being taken alone or with other drugs; such as MDMA, ketamine, cannabis, N,N-disopropyl-5- methoxytryptamine ("Foxy Methoxy") and N,N-dipropyltryptamine (DPT).
Information gathered by DEA 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; whereas in the Netherlands ("Blue Mystics"), and in Canada ("Red Raspberry") the bulk powder is being processed into tablets.
21 U.S.C. 811(c)(5) the Scope, Duration and Significance of Abuse
State and local law enforcement agencies reported 2C-T-7 exhibits seized in the states of Texas and Wisconsin. In Wisconsin, two unrelated exhibits were submitted to the Wisconsin State Crime Laboratory for analysis; the first exhibit consisted of two clear capsules containing 16 to 18 milligrams of white powder and two paper packets. One packet contained 450 milligrams of tan powder and the other paper packet contained 869 milligrams. The powder in these exhibits was identified as 2C-T-7. These two capsules were sold to an informant as "Tweety-Bird Mescaline." The second exhibit analyzed by the Wisconsin State Crime Laboratory was shown to be a mixture of 2C-T-7 and N,N-dipropyltryptamine (DPT). 2C-T-7 has also appeared in illicit traffic in Tennessee, Washington, and Oklahoma, as evidenced by the 2C-T-7 related deaths in these states. It is being sold under the "street names" Blue Mystic, T7, Beautiful, Tweety-Bird Mescaline or Tripstay. To date, DEA has not identified a clandestine laboratory synthesizing 2C-T-7.
21 U.S.C. 811(c)(6) What, If Any, Risk There Is to Public Health
2C-T-7 shares those structural similarities with 2CB and other phenethylamines (i.e., DOB, and DOM), which makes it likely to produce similar public health risks. 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 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 resulted from the co-abuse of 2C-T-7 with MDMA. They both occurred in April of 2001. One young man died in Tennessee while another man died in the state of Washington.
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 2C-T-7 indicate that it has a high potential for abuse, no currently accepted medical use in treatment in the United States and is not safe for use under medical supervision.
What Is The Role of the Assistant Secretary for Health in 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 2C-T-7 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 2C-T-7 under the Federal Food, Drug and Cosmetic Act, shall be taken into consideration before a final order is published.
Based on the above data, the continued distribution and abuse of 2C-T-7 poses an imminent risk to the public safety. There are no recognized therapeutic uses of this substance in the United States.
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 the available data and the three factors required for a determination to temporarily schedule 2C-T-7 under the CSA and finds that placement of 2C-T-7 into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety.
Because the Deputy Administrator finds that it is necessary to temporarily place 2C-T-7 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 in the Federal Register. 2C-T-7 will be subject to the regulatory controls and administrative, civil and criminal sanctions applicable to the manufacture, distribution, possession, importing and exporting of a Schedule I controlled substance under the CSA. 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 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 provides a notice of intent to temporarily place 2C-T-7 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 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 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 § 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 Recordkeeping 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 Department 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:
2. Section 1308.11 is to be amended by adding paragraph (g)(5) to read as follows:
* * * * *
(g) * * *
(5) 2,5-dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7), its optical isomers, salts and salts of isomers--7348.
* * * * *
Dated: July 9, 2002.
John B. Brown, III,
[FR Doc. 02-17902 Filed 7-17-02; 8:45 am]
BILLING CODE 4410-09-M