Source: https://www.federalregister.gov/documents/2010/12/20/2010-31854/schedules-of-controlled-substances-placement-of-5-methoxy-nn-dimethyltryptamine-into-schedule-i-of
Timestamp: 2018-11-21 13:51:36
Document Index: 431381054

Matched Legal Cases: ['§\u20091301', '§\u20091302', '§\u20091304', '§\u20091304', '§\u20091304', 'art 1305', 'art 1312']

Federal Register :: Schedules of Controlled Substances: Placement of 5-Methoxy-N,N-Dimethyltryptamine into Schedule I of the Controlled Substances Act
A Rule by the Drug Enforcement Administration on 12/20/2010
79296-79300 (5 pages)
Docket No. DEA-331F
https://www.federalregister.gov/d/2010-31854 https://www.federalregister.gov/d/2010-31854
With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), including its salts, isomers and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act (CSA). This action by the DEA Deputy Administrator is based on a scheduling recommendation from the Assistant Secretary for Health of the Department of Health and Human Services (DHHS) and a DEA review indicating that 5-MeO-DMT meets the criteria for placement in schedule I of the CSA. This final rule will impose the criminal sanctions and regulatory controls of schedule I substances under the CSA on the manufacture, distribution, dispensing, importation, exportation, and possession of 5-MeO-DMT.
In accordance with 21 U.S.C. 811(b) of the CSA, DEA gathered and reviewed the available information regarding the pharmacology, chemistry, trafficking, actual abuse, pattern of abuse, and the relative potential for abuse of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT). On February 21, 2007, the Deputy Administrator of the DEA submitted these data to the Assistant Secretary for Health, Department of Health and Human Services. In accordance with 21 U.S.C. 811(b), the Deputy Administrator also requested a scientific and medical evaluation and a scheduling recommendation for 5-MeO-Start Printed Page 79297DMT from the Assistant Secretary for Health.
5-MeO-DMT is related to the schedule I hallucinogens N,N-dimethyltryptamine (DMT), 2,5-dimethoxy-4-methylamphetamine (DOM), lysergic acid diethylamide (LSD) and mescaline in its pharmacological properties and hallucinogenic effects. In animal drug discrimination studies, DOM, LSD, mescaline, DMT, and alpha-methyltryptamine (AMT) fully substitute for the discriminative stimulus cue of 5-MeO-DMT. In in vitro receptor binding studies, 5-MeO-DMT, similar to DMT and other schedule I hallucinogens, binds to central serotonin 2 (5-HT2) receptors. Anecdotal reports from humans who have used 5-MeO-DMT describe hallucinogenic effects similar to those produced by DMT. 5-MeO-DMT, however, is reported to be 4 to 5-fold more potent than DMT when administered by inhalation, sublingual or oral (if encapsulated) routes of administration.
The risks to the public health associated with the abuse of 5-MeO-DMT are similar to the risks associated with those of schedule I hallucinogens. There have been reports of emergency room admissions and a death associated with the abuse of 5-MeO-DMT. 5-MeO-DMT has never been approved by the Food and Drug Administration (FDA) for marketing as a human drug product in the United States and there are no recognized therapeutic uses of 5-MeO-DMT in the United States.
On December 18, 2008, the Principal Deputy Assistant Secretary for Health, Department of Health and Human Services (DHHS), sent the Deputy Administrator of the DEA a scientific and medical evaluation and a letter recommending that 5-MeO-DMT and its salts be placed into schedule I of the CSA. Enclosed with the letter was a document prepared by FDA entitled, “Basis for the Recommendation To Control 5-Methoxy-Dimethyltryptamine (5-MeO-DMT) in Schedule I of the Controlled Substances Act.” The document contained a review of the factors which the CSA requires the Secretary to consider (21 U.S.C. 811(b)).
After a review of the available data, including the scientific and medical evaluation and the scheduling recommendation from DHHS, the Deputy Administrator of the DEA published a Notice of Proposed Rulemaking entitled “Schedules of Controlled Substances: Placement of 5-Methoxy-Dimethyltryptamine into Schedule I of the Controlled Substances Act” on August 21, 2009 (74 FR 42217), which proposed placement of 5-MeO-DMT in schedule I of the CSA. The proposed rule provided an opportunity for all interested persons to submit their written comments on or before September 21, 2009.
Length of comment or request for hearing period: Several commenters felt that the length of the comment or request for hearing period was too short and requested that the comment or request for hearing period be extended, to as much as 24 months. Some commenters noted the need to research pharmacological, religious or other evidence regarding 5-MeO-DMT and prepare comments and stated there was not enough time before the comment period closed to obtain or prepare this information.
In response to these comments, DEA does not believe that a further extension or reopening of the comment or request for hearing period is necessary or warranted. Pharmacological and abuse data on 5-MeO-DMT are publicly available and easily retrievable. The period for comments and requests for hearings with regard to the Notices of Proposed Rulemaking was thirty (30) days from the date of publication of each Notice of Proposed Rulemaking. Interested persons who wished to submit written data, views or arguments have had ample opportunity to use the information in the medical and scientific literature, which are available to the public from various resources (e.g., U.S. National Library of Medicine, public libraries, and Web sites of scientific journals), along with the supplemental information provided by DEA (i.e., DEA's scheduling review document and FDA's scientific and medical evaluation and scheduling recommendation) as well as other sources of information such as publications by Federal agencies (e.g., reports from DEA's NFLIS, National Institute on Drug Abuse's (NIDA) National Survey on Drug Use and Health, Substance Abuse and Mental Start Printed Page 79298Health Services Administration's Drug Abuse Warning Network, and NIDA's Monitoring the Future) to submit meaningful comments on 5-MeO-DMT that can be supported by data or scientific arguments. These data are publicly available and easily retrievable. DEA has considered the amount of time needed to obtain and review documents and supporting materials relevant to the commenter's position, prepare the comment, and submit the comment and finds that a 30-day comment period provides a meaningful opportunity for interested persons to submit comments or request a hearing. While commenters indicated that an extension of the comment period would allow time for further research regarding 5-MeO-DMT, DEA notes that this scheduling action does not prevent such research from occurring. Any person wishing to conduct research using 5-MeO-DMT may do so provided that the person has obtained a schedule I researcher registration with DEA, has the appropriate research protocols in place with FDA, and meets all other requirements.
Use of http://www.regulations.gov: Several commenters discussed the use of http://www.regulations.gov, the government's online Federal Docket Management System (FDMS). Commenters stated that the document reopening the comment period was posted to the electronic docket on http://www.regulations.gov on October 28, 2009, but that certain supporting materials were not posted until November 3, 2009. In a related comment, a commenter objected to the “splitting” of the electronic docket for the reopening of the comment period from the electronic docket for the Notice of Proposed Rulemaking. The commenter indicated that “splitting” the dockets made it difficult to view all docket components and made it “extremely difficult to communicate to others where and how to locate, view, or comment on Docket No. DEA-331.”
Control of DMT: One commenter questioned the evidence considered by DEA to make the findings to control “DMT.” DEA finds that this comment is not relevant to the present scheduling action as this Final Rule pertains to the scheduling of 5-MeO-DMT. However, if the commenter intended to refer to 5-MeO-DMT and not DMT, the reasons for controlling 5-MeO-DMT have already been provided.
Constitutional concerns: Several commenters raised concerns that the proposed rule would substantially impair religious liberty. The commenters raised two specific concerns with respect to religion. First, the commenters questioned the proposed rule on the ground that the CSA, which authorizes this rulemaking, violates both the Free Exercise Clause and the Establishment Clause of the First Amendment. DEA has fully considered these concerns, and does not believe any change in the rule is necessary. With respect to the Free Exercise Clause, one commenter claimed that the CSA is not a neutral law of general applicability under Employment Division v. Smith, 494 U.S. 872 (1990), because the CSA includes exemptions for the use of alcohol, certain research and medical uses of certain substances, and the sacramental use of peyote by the Native American Church. This concern has been raised previously in litigation, and courts have concluded that the CSA does not interfere with the free exercise of religion in violation of the First Amendment. See Olsen v. Mukasey, 541 F.3d 827 (8th Cir. 2008); O Centro Espirita Beneficiente Uniao do Vegetal v. Mukasey, No. 00-1647 (D. N. M. June 16, 2008). The commenter raised similar concerns about the CSA with respect to the Establishment Clause of the First Amendment. Once again, courts have Start Printed Page 79299upheld the validity of the CSA in the face of related challenges and concluded that the statute does not represent an establishment of religion in contravention of the First Amendment. Peyote Way Church of God v. Thornburgh, 922 F.2d 1210 (5th Cir. 1991); United States v. Valazquez, 2009 WL 2823730 (W.D. Okla. Aug. 31, 2009).
Another commenter suggested that if the final rule scheduling 5-MeO-DMT is issued without change, DEA should consider “providing special exemption for religious use.” The commenter did not provide any specific details about the kind of exemption that he believed would be appropriate. Accordingly, DEA lacks the information necessary to evaluate this comment.
Security. 5-MeO-DMT is subject to schedule I security requirements and must be manufactured, distributed and stored in accordance with §§ 1301.71; 1301.72(a), (c), and (d); 1301.73; 1301.74; 1301.75(a) and (c); and 1301.76 of Title 21 of the Code of Federal Regulations on or after January 19, 2011.
Labeling and Packaging. All labels and labeling for commercial containers of 5-MeO-DMT which are distributed on or after January 19, 2011 must comply with the requirements of §§ 1302.03 through 1302.07 of Title 21 of the Code of Federal Regulations on or after January 19, 2011.
Inventory. Every registrant required to keep records and who possesses any quantity of 5-MeO-DMT must keep an inventory of all stocks of 5-MeO-DMT on hand pursuant to §§ 1304.03, 1304.04 and 1304.11 of Title 21 of the Code of Federal Regulations on or after January 19, 2011. Every registrant who desires registration in schedule I to handle 5-MeO-DMT must conduct an inventory of all stocks of the substance.
Records. All registrants who handle 5-MeO-DMT must keep records pursuant to §§ 1304.03, 1304.04, 1304.21, 1304.22, and 1304.23 of Title 21 of the Code of Federal Regulations on or after January 19, 2011.
Reports. All registrants required to submit reports in accordance with § 1304.33 of Title 21 of the Code of Federal Regulations must do so regarding 5-MeO-DMT on and after January 19, 2011.
Order Forms. All registrants involved in the distribution of 5-MeO-DMT must comply with the order form requirements of part 1305 of Title 21 of the Code of Federal Regulations on and after January 19, 2011.
Importation and Exportation. All importation and exportation of 5-MeO-DMT must be in compliance with part 1312 of Title 21 of the Code of Federal Regulations on or after January 19, 2011.
This rule will not result in the expenditure by State, local and Tribal governments, in the aggregate, or by the private sector, of $126,400,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of 1995.Start Printed Page 79300