```

[Federal Register Volume 77, Number 201 (Wednesday, October 17, 2012)]
[Proposed Rules]
[Pages 63766-63771]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25509]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-357]

Schedules of Controlled Substances: Placement of Methylone Into 
Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration (DEA) proposes placing 
3,4-methylenedioxy-N-methylcathinone (methylone) 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 proposed action is pursuant to 
the CSA which requires that such actions be made on the record after 
opportunity for a hearing through formal rulemaking.

DATES: DEA will permit interested persons to file written comments on 
this proposal pursuant to 21 CFR 1308.43(g). Electronic comments must 
be submitted and written comments must be postmarked on or before 
December 17, 2012. Commenters should be aware that the electronic 
Federal Docket Management System will not accept comments after 
midnight Eastern Time on the last day of the comment period.
    Interested persons, defined at 21 CFR 1300.01 as those ``adversely 
affected or aggrieved by any rule or proposed rule issuable pursuant to 
section 201 of the Act (21 U.S.C. 811),'' may file a request for 
hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 
1316.45 and 1316.47. Requests for hearing, notices of appearance, and 
waivers of participation must be received on or before November 16, 
2012.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-357'' on all electronic and written correspondence. 
DEA encourages all comments be submitted electronically through http://www.regulations.gov using the electronic comment form provided on that 
site. An electronic copy of this document and supplemental information 
to this proposed rule are also available at the http://www.regulations.gov Web site for easy reference. Paper comments that 
duplicate the electronic submission are not necessary as all comments 
submitted to www.regulations.gov will be posted for public review and 
are part of the official docket record. Should you, however, wish to 
submit written comments via regular or express mail, they should be 
sent to the Drug Enforcement Administration, Attention: DEA Federal 
Register Representative/OD, 8701 Morrissette Drive, Springfield, VA 
22152. All requests for hearing must be sent to Drug Enforcement 
Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, VA 22152.

FOR FURTHER INFORMATION CONTACT: Alan G. Santos, Associate Deputy 
Assistant Administrator, Office of Diversion Control, Drug Enforcement 
Administration; Mailing Address: 8701 Morrissette Drive, Springfield, 
Virginia 22152; Telephone: (202) 307-7165.

SUPPLEMENTARY INFORMATION:
    Posting of Public Comments: Please note that all comments received 
are considered part of the public record and made available for public 
inspection online at http://www.regulations.gov and in the DEA's public 
docket. Such information includes personal identifying information 
(such as your name, address, etc.) voluntarily submitted by the 
commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all of the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted, 
and the comment, in redacted form, will be posted online and placed in 
the DEA's public docket file. Please note that the Freedom of 
Information Act applies to all comments received. If you wish to 
inspect the agency's public docket file in person by appointment, 
please see the For Further Information paragraph.

Request for Hearing, Notice of Appearance at or Waiver of Participation 
in Hearing

    In accordance with the CSA, this action is a formal rulemaking ``on 
the record after opportunity for a hearing.'' 21 U.S.C. 811(a). Such 
proceedings are conducted pursuant to the provisions of the 
Administrative Procedure Act (5 U.S.C. 556 and 557) and 21 CFR 1308.41. 
Pursuant to 21 CFR 1308.44(a)-(c), requests for hearing, notices of 
appearance, and waivers of participation may be submitted only by 
interested persons, defined at 21 CFR 1300.01 as those ``adversely 
affected or aggrieved by any rule or proposed rule issuable pursuant to 
section 201 of the Act (21 U.S.C. 811).'' Such requests or notices must 
conform to the requirements of 21 CFR 1308.44(a) or (b) and 1316.47 or 
1316.48, as applicable. A request or notice should state, with 
particularity, the interest of the person in the proceeding and the 
objections or issues, if any, concerning which the person desires to be 
heard. Any waiver must conform to the requirements of 21 CFR 1308.44(c) 
and 1316.49, including a written statement regarding the interested 
person's position on the matters of fact and law involved in any 
hearing.
    Please note that pursuant to 21 U.S.C. 811(a), the purpose and 
subject matter of the hearing is restricted to ``(A) find[ing] that 
such drug or other substance has a potential for abuse, and (B) 
mak[ing] with respect to such drug or other substance the findings 
prescribed by subsection (b) of section 812 of this title for the 
schedule in which such drug is to be placed * * *'' Requests for 
hearing, notices of appearance at the hearing, and waivers of 
participation in the hearing should be submitted to DEA using the 
address information provided above.

Legal Authority

    The DEA implements and enforces Titles II and III of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970, often 
referred to as the Controlled Substances Act and the Controlled 
Substances Import and

[[Page 63767]]

Export Act (21 U.S.C. 801-971), as amended (hereinafter, ``CSA''). The 
implementing regulations for these statutes are found in Title 21 of 
the Code of Federal Regulations (CFR), parts 1300 to 1321. Under the 
CSA, controlled substances are classified in one of five schedules 
based upon their potential for abuse, their currently accepted medical 
use, and the degree of dependence the substance may cause. 21 U.S.C. 
812. The initial schedules of controlled substances by statute are 
found at 21 U.S.C. 812(c) and the current list of scheduled substances 
are published at 21 CFR Part 1308.
    The CSA permits these schedules to be modified by providing that 
scheduling of any drug or other substance may be initiated by the 
Attorney General (1) on his own motion; (2) at the request of the 
Secretary of HHS, or (3) on the petition of any interested party. 21 
U.S.C. 811(a). The Attorney General may, by rule, ``add to such a 
schedule or transfer between such schedules any drug or other substance 
if he (A) finds that such drug or other substance has a potential for 
abuse, and (B) makes with respect to such drug or other substance the 
findings prescribed by subsection (b) of section 812 of this title for 
the schedule in which such drug is to be placed * * *'' 21 U.S.C. 
811(a). The findings required for the placement of a controlled 
substance in Schedule I are: ``(A) The drug or other substance has a 
high potential for abuse. (B) The drug or substance has no currently 
accepted medical use in treatment in the United States. (C) There is a 
lack of accepted safety for use of the drug or other substance under 
medical supervision.'' 21 U.S.C. 812(b).

Background

    On September 8, 2011, the Administrator of the DEA published a 
Notice of Intent to temporarily place 3,4-methylenedioxy-N-
methylcathinone (methylone) along with two other synthetic cathinones 
(4-methyl-N-methylcathinone (mephedrone) and 3,4-
methylenedioxypyrovalerone (MDPV)) into Schedule I pursuant to the 
temporary scheduling provisions of the CSA (76 FR 55616). Following 
this, on October 21, 2011, the Administrator published a Final Order in 
the Federal Register (76 FR 65371) amending 21 CFR 1308.11(g) to 
temporarily place these three synthetic cathinones into Schedule I of 
the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 
811(h). This Final Order, which became effective on the date of 
publication, was based on findings by the Administrator of the DEA that 
the temporary scheduling of these three synthetic cathinones was 
necessary to avoid an imminent hazard to the public safety pursuant to 
21 U.S.C. 811(h)(1). At the time the Final Order took effect, Section 
201(h)(2) of the CSA (21 U.S.C. 811(h)(2) (2011)) required that the 
temporary scheduling of a substance expire at the end of one year from 
the date of issuance of the scheduling order, and it provided that, 
during the pendency of proceedings under 21 U.S.C. 811(a)(1) with 
respect to the substance, temporary scheduling of that substance could 
be extended for up to six months.\1\ Under this provision, the 
temporary scheduling of methylone expires on October 20, 2012, unless 
extended pursuant to 21 U.S.C. 811(h)(2). An extension until April 20, 
2013, is being ordered by the Administrator in a separate action.
---------------------------------------------------------------------------

    \1\ On July 9, 2012, President Obama signed the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144) (FDASIA), 
which amended several provisions of the CSA. Subtitle D of FDASIA is 
titled the ``Synthetic Drug Abuse Prevention Act of 2012.'' In 
particular, FDASIA amended Schedule I of section 202(c) of the CSA 
to include mephedrone and MDPV but not methylone, and amended 
section 201(h)(2) to increase the maximum timeframes for temporary 
scheduling. Public Law 112-144, Sections 1152(b) and 1153.
---------------------------------------------------------------------------

    As described in the October 21, 2011, Final Order, methylone is a 
designer drug of the phenethylamine class and is structurally and 
pharmacologically similar to amphetamine, 3,4-
methylenedioxymethamphetamine (MDMA), cathinone and other related 
substances. The addition of a beta-keto ([beta]-ketone) substituent to 
the phenethylamine core structure produces a group of substances that 
have [beta]-keto-phenethylamine as the core structure. Methylone has a 
[beta]-keto-phenethylamine core structure. Methylone has been used as 
research chemical. Based on the review of the scientific literature, 
there are no known medical uses for methylone. The Assistant Secretary 
of Health for the U.S. Department of Health and Human Services (HHS) 
has advised that there are no exemptions or approvals in effect for 
methylone under section 505 (21 U.S.C. 355) of the Federal Food, Drug 
and Cosmetic Act.

Proposed Determination To Schedule Methylone

    This NPRM proposes the permanent scheduling of methylone pursuant 
to 21 U.S.C. 811(a)(1). On March 30, 2012, DEA requested a scientific 
and medical evaluation and scheduling recommendation from the Assistant 
Secretary of Health for HHS for methylone, mephedrone and MDPV pursuant 
to 21 U.S.C. 811(b). Upon receipt and evaluation of the scientific and 
medical evaluation and scheduling recommendation from the Assistant 
Secretary,\2\ DEA concluded its analysis of all other relevant data for 
the proposal to place methylone into Schedule I of the CSA.
---------------------------------------------------------------------------

    \2\ DEA received from HHS Evaluation and Recommendation 
documents with respect to methylone, but not for mephedrone and 
MDPV. However, mephedrone and MDPV are listed as Schedule I 
substances under FDASIA.
---------------------------------------------------------------------------

    Included below is a brief summary of each factor as analyzed by HHS 
and DEA, and as considered by DEA in the scheduling decision. Please 
note that both the DEA and HHS analyses are available under 
``Supporting and Related Material'' of the public docket for this 
proposed rule at www.regulations.gov under docket number DEA-357.
    1. The Drug's Actual or Relative Potential for Abuse: The abuse 
potential of methylone is associated with its ability to evoke 
pharmacological effects similar to those evoked by the Schedule I and 
II substances such as cathinone (Schedule I), methcathinone (Schedule 
I), 3,4-MDMA (Schedule I), amphetamine (Schedule II), methamphetamine 
(Schedule II), and cocaine (Schedule II). These Schedule I and II 
substances have a high potential for abuse.
    The legislative history of the CSA suggests the following four 
prongs to consider in determining whether a particular drug or 
substance has potential for abuse: \3\
---------------------------------------------------------------------------

    \3\ Comprehensive Drug Abuse Prevention and Control Act of 1970, 
H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); 1970 U.S.C.C.A.N. 
4566, 4601.
---------------------------------------------------------------------------

    i. There is evidence that individuals are taking the drug or other 
substance in amounts sufficient to create a hazard to their health or 
to the safety of other individuals or to the community; or
    ii. There is significant diversion of the drug or substance from 
legitimate drug channels; or
    iii. Individuals are taking the substance on their own initiative 
rather than on the basis of medical advice from a practitioner licensed 
by law to administer such drugs; or
    iv. The drug is a new drug so related in its action to a drug or 
other substance already listed as having a potential for abuse to make 
it likely that the drug or other substance will have the same potential 
for abuse as such drugs, thus making it reasonable to assume that there 
may be significant diversion from legitimate channels, significant use 
contrary to or without medical advice, or that it has a substantial 
capability of creating hazards to the health of the user or to the 
safety of the community.

[[Page 63768]]

    With respect to the first prong, a number of case reports and case 
series have shown that individuals are taking methylone and products 
containing methylone in amounts sufficient to induce adverse health 
effects similar to those induced by amphetamine, methamphetamine, and 
MDMA, Schedule I and II substances. These effects included elevated 
body temperature, increases in heart rate and respiratory exchange, 
changes in blood pressure, seizures, erratic behavior, and coma. Even 
death has been reported following the abuse of methylone or products 
containing methylone. Further, law enforcement encounters indicate the 
occurrence of a fatal automotive accident that was caused by a driver 
under the influence of a product containing methylone.
    In considering evidence of significant diversion of the drug or 
substance from legitimate drug channels under the second prong, it must 
be noted that as of October 21, 2011, methylone has been temporarily 
controlled as a Schedule I substance and thus has not been legally 
available unless for research purposes. However, the National Forensic 
Laboratory Information System (NFLIS), which details over 2,500 reports 
from state and local forensic laboratories, identified methylone in 
drug related exhibits for a period from January 2009 to June 2012 from 
42 states. The System to Retrieve Information from Drug Evidence 
(STRIDE), which details reports from federal forensic laboratories, 
identified methylone in 220 drug related exhibits from a period from 
January 2009 to June 2012.
    For the third prong, HHS states that there is no currently accepted 
medical use for methylone and no medical practitioner is currently 
licensed by law to administer methylone. Indeed, the FDA has not 
approved a new drug application (NDA) for methylone for any therapeutic 
indication, and no investigational new drug (IND) application for 
methylone is currently active. Thus, with no accepted medical use or 
administering practitioners, individuals currently using products 
containing methylone are doing so on their own initiative without 
medical advice from a practitioner licensed to administer methylone.
    With regard to the fourth prong, HHS states that methylone produces 
pharmacological effects similar to those produced by the Schedule I and 
II central nervous system (CNS) substances such as amphetamine, 
methamphetamine, cocaine, and MDMA which have a high potential for 
abuse. Methylone, like these Schedule I and II substances, affects the 
concentrations of the neurotransmitters dopamine, serotonin and 
norepinephrine in the CNS. In drug discrimination assays, methylone 
substitutes for MDMA, amphetamine, methamphetamine, and cocaine, which 
suggests that methylone will likely produce subjective effects in 
humans similar to these substances and have a similar pattern of abuse. 
Methylone, like methamphetamine, amphetamine, and cocaine, is a CNS 
stimulant and produces locomotor stimulant activity in animals.
    Methylone has no known medical use in the United States but 
evidence demonstrates that methylone is being abused by individuals for 
its psychoactive effects. Methylone has been encountered by law 
enforcement throughout the United States as reported in NFLIS and in 
STRIDE databases suggesting that individuals are abusing methylone. 
Methylone has also been identified during the toxicological screening 
of individual human urine samples which also demonstrates that 
individuals are abusing this substance. In addition, information from 
poison centers indicates the abuse of synthetic cathinones which likely 
include methylone. The American Association of Poison Control Centers 
(AAPCC) \4\ reported in a press release that poison centers took 304 
calls in 2010 regarding synthetic cathinone exposures and 6,138 calls 
in 2011. As of September 12, 2012, poison centers have received 2,251 
calls relating to these products this year. These calls were received 
in poison centers representing at least 47 states and the District of 
Columbia. Although methylone may not be specifically identified during 
exposure calls or identified by toxicology testing by AAPCC, it is 
likely that some of these retail products described by the callers 
contained methylone, based on the identification of methylone in 
approximately 26% of all synthetic cathinones related exhibits reported 
to NFLIS from January 2009 to June 2012.
---------------------------------------------------------------------------

    \4\ AAPCC is a non-profit, national organization that represents 
the poison centers of the United States.
---------------------------------------------------------------------------

    State public health and poison centers have warned of the dangers 
associated with the use of synthetic cathinones and their associated 
products being found on the designer drug market. In response to the 
abuse of methylone and other synthetic cathinones, as of September 
2012, at least 42 states have emergency scheduled or enacted 
legislation placing regulatory controls on some or many of the 
synthetic cathinones including mephedrone, methylone, MDPV and/or a 
defined general class of cathinones. At least 27 states specifically 
control methylone. Numerous local jurisdictions have also placed 
controls on methylone and other synthetic cathinones. All five branches 
of the U.S. military prohibit military personnel from possessing or 
using synthetic cathinones including methylone.
    Methylone has been reported to cause a number of adverse effects 
that are characteristic of stimulants like methamphetamine, 
amphetamine, and cocaine. Adverse effects associated with the 
consumption of methylone include those typical of a sympathomimetic 
agent such as palpitations, hyperthermia, seizures, hyponatremia, 
bruxism, sweating, hypertension, tachycardia, headache, palpitations, 
thirst, mydriasis, tremor, fever, sweating, and hypertension. Other 
effects that have been reported from the use of methylone include 
psychological effects such as confusion, psychosis, paranoia, 
hallucinations, combativeness, and agitation. Finally, reports of death 
for individuals abusing methylone indicate that methylone is a serious 
public health threat.
    2. Scientific Evidence of the Drug's Pharmacological Effects, If 
Known: In the recommendation from HHS for the placement of methylone in 
Schedule I of the CSA, HHS states that based on the results of 
preclinical studies and the toxicological profile observed in emergency 
room cases and medical examiner cases it is probable that methylone 
produces pharmacological effects in humans that are similar to those 
produced by the Schedule I and II substances amphetamine, 
methamphetamine, cocaine, and MDMA. These findings are based on 
published data on the release of monoamines, inhibition of reuptake of 
monoamines, and in vivo studies (microdialysis, locomotor activity, 
body temperature, drug discrimination) and are also based on data from 
studies (locomotor, drug discrimination, in vitro receptor binding, and 
functional assays) conducted by National Institute on Drug Abuse (NIDA) 
contract researchers. The preclinical data showed that methylone can 
substitute for MDMA or amphetamine in rats trained to discriminate 
amphetamine or MDMA, respectively. Methylone, like methamphetamine, 
amphetamine, and cocaine, is a CNS stimulant and produces locomotor 
stimulant effects in animals. Methylone, like methamphetamine, has a 
rewarding effect as evidenced by conditioned place preference tests. 
Methylone is an inhibitor of dopamine, serotonin and norepinephrine 
uptake and also causes the release of these neurotransmitters in

[[Page 63769]]

the CNS. Furthermore, studies show that methylone, like MDMA, can be 
cytotoxic to liver cells. HHS further states that the toxicological 
profile observed in emergency room and medical examiner cases involving 
methylone demonstrate that the pharmacological profile observed in 
humans is in accordance with preclinical data.
    3. The State of Current Scientific Knowledge Regarding the Drug or 
Other Substance: Methylone is a [beta]-ketophenethylamine (i.e., 
synthetic cathinone) that is structurally and pharmacologically similar 
to amphetamine, methamphetamine, MDMA, cathinone and other related 
substances. Methylone can be prepared from its corresponding ketone by 
a two-step synthesis. Studies indicate that humans metabolize methylone 
and metabolites of methylone have been found in the urine samples of 
humans and animals given methylone. Research in anti-depressant and 
anti-parkinson agents resulted in the synthesis and patenting of 
methylone. According to HHS, methylone has no approved medical use in 
the United States, does not have an approved NDA, and is not currently 
marketed in the United States in an FDA-approved drug product. A drug 
has a ``currently accepted medical use'' if all of the following five 
elements have been satisfied: the drug's chemistry is known and 
reproducible; and there are adequate safety studies; and there are 
adequate and well-controlled studies proving efficacy; and the drug is 
accepted by qualified experts; and the scientific evidence is widely 
available. 57 Fed. Reg. 10499 (March 26, 1992). According to HHS, there 
are no published clinical studies involving methylone. DEA has also not 
found any references to clinical studies involving methylone's efficacy 
and safety in the scientific and medical literature. Although the 
chemistry of methylone is known and has been reproduced, as mentioned 
above there are no clinical studies involving methylone. Thus, 
methylone has no currently accepted medical use in treatment in the 
United States and there is a lack of accepted safety for use of 
methylone under medical supervision.
    4. Its History and Current Pattern of Abuse: Methylone is a 
synthetic cathinone that emerged on the United States' illicit drug 
market in 2009 and prior to its temporary control was perceived as 
being a `legal' alternative to cocaine, methamphetamine, and MDMA. 
Methylone is falsely marketed as ``research chemicals,'' ``plant 
food,'' or ``bath salts'' and has been sold at smoke shops, head shops, 
convenience stores, adult book stores, and gas stations and can also be 
purchased on the Internet under a variety of product names (White Dove, 
Explosion, Tranquility etc.). It is commonly encountered in the form of 
powders, capsules, and tablets. The packages of these commercial 
products usually contain the warning ``not for human consumption.'' 
Poison centers reported a large number of toxic exposures to these 
products as indicated by the number of exposure calls related to 
synthetic cathinones. A large majority of these exposures were by 
intentional abuse, misuse, or suspected suicide. Most of these 
exposures were described as acute. AAPCC data also identified the most 
common route of administration for the synthetic cathinones as 
inhalation/nasal. Information from published scientific studies 
indicate that the most common routes of administration for methylone is 
ingestion by swallowing capsules or tablets or nasal insufflation by 
snorting the powder. Evidence from poison centers, published case 
reports, and law enforcement encounters suggest that the main users of 
methylone are young adults. These substances are popular among youths 
and young adults with males appearing to abuse methylone more than 
females. There is evidence that methylone may be co-ingested with other 
substances including other synthetic cathinones, pharmaceutical agents, 
or other recreational substances.
    5. The Scope, Duration, and Significance of Abuse: Evidence that 
methylone is being abused is confirmed by drug courts,\5\ calls to 
poison centers, and encounters by law enforcement. Methylone has been 
identified in specimens from individuals submitted for testing by drug 
court participants. Drug courts submitted to DEA 18 reports that detail 
the analysis of biological specimens that contained synthetic 
cathinones. Methylone was mentioned in 5 of these reports. Evidence 
from poison centers also indicates that the abuse of synthetic 
cathinones like methylone is widespread. The AAPCC reported in a press 
release that poison centers took 304 calls in 2010 regarding synthetic 
cathinone exposures and 6,138 calls in 2011. As of September 12, 2012, 
poison centers have received 2,251 calls relating to these products 
this year. These calls were received in poison centers representing at 
least 47 states and the District of Columbia. Methylone may not have 
been specifically mentioned during the exposure calls but it is likely 
that some of these retail products described by the callers contained 
methylone based on the identification of methylone in approximately 26% 
of all synthetic cathinones related exhibits reported to NFLIS from 
January 2009 to June 2012. Evidence of the increased abuse of methylone 
is supported by law enforcement encounters of methylone. Forensic 
laboratories have analyzed drug exhibits received from state, local, or 
federal law enforcement agencies that were found to contain methylone. 
The National Forensic Laboratory Information System (NFLIS) is a 
program sponsored by DEA's Office of Diversion Control. NFLIS compiles 
information on exhibits analyzed in state and local law enforcement 
laboratories. The System to Retrieve Information from Drug Evidence 
(STRIDE) is a DEA database which compiles information on exhibits 
analyzed in DEA laboratories. NFLIS and STRIDE together capture data 
for all substances reported by forensic laboratory analyses. Methylone 
has been encountered by law enforcement as reported in NFLIS.\6\ NFLIS 
details 2,797 reports from state and local forensic laboratories 
identifying methylone in drug related exhibits for a period from 
January 2009 to June 2012 from 42 States. NFLIS registered 4 reports 
from 3 states containing methylone in 2009. However, there were 71 
reports from 18 states related to these substances registered in NFLIS 
in 2010 and there were 1,655 reports from 41 states in 2011. From 
January to June 2012 there were 1,067 reports from 36 states. STRIDE 
also details 220 reports from federal forensic laboratories identifying 
methylone in drug related exhibits for a period from January 2009 to 
June 2012. STRIDE (which reports data from 6 DEA laboratories) 
registered 1 exhibit pertaining to methylone in 2009. There were 7 
exhibits pertaining to the trafficking, distribution and abuse of 
methylone registered in STRIDE in 2010 and 107 drug exhibits in 2011. 
In 2012, 105 drug exhibits pertaining to the trafficking, distribution 
and abuse of methylone were recorded in the STRIDE database.
---------------------------------------------------------------------------

    \5\ Drug courts were developed to achieve a reduction in 
recidivism and substance abuse among nonviolent, substance abusing 
offenders by increasing their likelihood for successful 
rehabilitation through early, continuous, and intense judicially 
supervised treatment, mandatory periodic drug testing, and the use 
of appropriate sanctions and other rehabilitation services. Drug 
courts analyze specimens from participants for new and existing 
drugs of abuse.
    \6\ State and local forensic drug reports from January 2009 to 
June 2012, analyzed on September 12, 2012. The 2012 drug reports are 
likely to be incomplete as of September 12, 2012, due to laboratory 
reporting lag time.

---------------------------------------------------------------------------

[[Page 63770]]

    At selected United States ports of entry, the U.S. Customs and 
Border Protection (CBP) has encountered shipments of products 
containing methylone. The most commonly identified synthetic cathinone 
was methylone. As of July 2012, methylone was identified in 127 of 330 
shipments encountered by CBP from June 2008 to July 2012. These 
shipments of methylone were in powdered form ranging from gram to 
multi-kilogram quantities. Most of the shipments of these synthetic 
cathinones that contained methylone originated in China and were 
destined for delivery throughout the United States to places like 
Alaska, Arizona, Arkansas, California, Colorado, Florida, Hawaii, 
Illinois, Kansas, Louisiana, Oklahoma, Oregon, Missouri, Nevada, New 
Mexico, Tennessee, Texas, Washington, and West Virginia.
    Concerns over the abuse of methylone and other synthetic cathinones 
have prompted many states to control these substances. As of September 
2012, at least 42 states have emergency scheduled or enacted 
legislation placing regulatory controls on some or many of the 
synthetic cathinones including methylone. In addition, the U.S. Armed 
Forces prohibited the use of synthetic cathinones including mephedrone, 
methylone and MDPV.
    6. What, if any, Risk There is to the Public Health: Law 
enforcement, military, and public health officials have reported 
exposure incidents that demonstrate the dangers associated with 
methylone to both the individual abusers and other affected 
individuals. Numerous individuals have presented at emergency 
departments following exposure to methylone or products containing 
methylone. Case reports describe presentations to emergency departments 
of individuals exposed to methylone with symptoms that include 
tachycardia, headache, palpitations, agitation, anxiety, mydriasis, 
tremor, fever, sweating, and hypertension. Some individuals under the 
influence of methylone have acted violently and unpredictably causing 
harm, or even death, to themselves or others. In addition, individuals 
suspected of driving under the influence of intoxicating substances 
have been found to have positive test results for methylone and some of 
these incidents involving methylone intoxications have resulted in the 
deaths of individuals. There are at least three reported deaths in 
which methylone was ruled as the cause of death by the medical examiner 
or after an autopsy and there are many reports in which methylone was 
implicated (i.e., the primary cause of death is not methylone toxicity) 
in deaths. Additionally, products containing methylone and other 
synthetic cathinones often do not bear labeling information regarding 
their ingredients, and if they do it may not contain the expected 
active ingredients or identify the health risks and potential hazards 
associated with these products.
    7. Its Psychic or Physiological Dependence Liability: According to 
HHS, there are no studies or case reports that document the psychic or 
physiological dependence potential of methylone. However, HHS states 
that because methylone shares pharmacological properties with those of 
the Schedule I and II substances amphetamine, methamphetamine, cocaine, 
and MDMA, it is probable that methylone has a dependence profile 
similar to that of these substances which are known to cause substance 
dependence.
    8. Whether the Substance is an Immediate Precursor of a Substance 
Already Controlled Under the CSA: Methylone is not considered an 
immediate precursor of any controlled substance of the CSA as defined 
by 21 U.S.C 802(23).
    Conclusion: Based on consideration of the scientific and medical 
evaluation and accompanying recommendation of HHS, and based on DEA's 
consideration of its own eight-factor analysis, DEA finds that these 
facts and all relevant data constitute substantial evidence of 
potential for abuse of methylone. As such, DEA hereby proposes to 
schedule methylone as a controlled substance under the CSA.

Proposed Determination of Appropriate Schedule

    The CSA establishes five schedules of controlled substances known 
as Schedules I, II, III, IV, and V. The statute outlines the findings 
required to place a drug or other substance in any particular schedule. 
21 U.S.C. 812(b). After consideration of the analysis and 
recommendations of the Assistant Secretary for Health of HHS and review 
of all available data, the Administrator of DEA, pursuant to 21 U.S.C. 
812(b)(1), finds that:
    (1) 3,4-methylenedioxy-N-methylcathinone (methylone) has a high 
potential for abuse;
    (2) 3,4-methylenedioxy-N-methylcathinone (methylone) has no 
currently accepted medical use in treatment in the United States; and
    (3) There is a lack of accepted safety for use of 3,4-
methylenedioxy-N-methylcathinone (methylone) under medical supervision.
    Based on these findings, the Administrator of DEA concludes that 
3,4-methylenedioxy-N-methylcathinone (methylone) including its salts, 
isomers and salts of isomers, whenever the existence of such salts, 
isomers, and salts of isomers is possible, warrants control in Schedule 
I of the CSA (21 U.S.C. 812(b)(1)).

Requirements for Handling Methylone

    Methylone is currently scheduled on a temporary basis in Schedule I 
and is subject to the CSA regulatory controls and administrative, 
civil, and criminal sanctions applicable to the manufacture, 
distribution, possession, dispensing, importing, and exporting of a 
Schedule I controlled substance, including those listed below. These 
controls on methylone will continue on a permanent basis if this rule 
is finalized as proposed:
    Registration. Any person who manufactures, distributes, dispenses, 
imports, exports, engages in research or conducts instructional 
activities with methylone or who desires to manufacture, distribute, 
dispense, import, export, engage in research or conduct instructional 
activities with methylone would need to be registered to conduct such 
activities pursuant to 21 U.S.C. 822 and 958 and in accordance with 21 
CFR Part 1301.
    Security. Methylone would be subject to Schedule I security 
requirements and would need to be manufactured and distributed pursuant 
to 21 U.S.C. 823 and in accordance with 21 CFR 1301.71, 1301.72(a), (c) 
and (d), 1301.73, 1301.74, 1301.75(a) and (c), 1301.76.
    Labeling and Packaging. All labels and labeling for commercial 
containers of methylone which is distributed on or after the effective 
date of the finalization of this rule would need to be in accordance 
with 21 CFR 1302.03-1302.07, pursuant to 21 U.S.C. 825.
    Quotas. Quotas for methylone will be established based on 
registrations granted and quota applications received pursuant to part 
1303 of Title 21 of the Code of Federal Regulations.
    Inventory. Every registrant required to keep records and who 
possesses any quantity of methylone would be required to keep an 
inventory of all stocks of methylone on hand pursuant to 21 U.S.C. 827 
and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Every 
registrant who desires registration in Schedule I for methylone would 
be required to conduct an inventory of all stocks of the substance on 
hand at the time of registration.
    Records. All registrants would be required to keep records pursuant 
to 21 U.S.C. 827 and in accordance with 21

[[Page 63771]]

CFR 1304.03, 1304.04, 1304.21, 1304.22, and 1304.23.
    Reports. All registrants required to submit reports pursuant to 21 
U.S.C. 827 and in accordance with 21 CFR 1304.33 would be required to 
do so regarding methylone.
    Order Forms. All registrants involved in the distribution of 
methylone would be required to comply with the order form requirements 
pursuant to 21 U.S.C. 828 and 21 CFR 1305.
    Importation and Exportation. All importation and exportation of 
methylone would need to be done in accordance with 21 CFR Part 1312, 
pursuant to 21 U.S.C. 952, 953, 957, and 958.
    Criminal Liability. Any activity with methylone not authorized by, 
or in violation of, Subchapter I Part D and Subchapter II of the CSA 
occurring on or after effective date of the finalization of this 
proposed rule would be unlawful.

Regulatory Analyses

Executive Orders 12866 and 13563

    In accordance with 21 U.S.C. 811(a), this proposed scheduling 
action is subject to formal rulemaking procedures done ``on the record 
after opportunity for a hearing,'' which are conducted pursuant to the 
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for 
scheduling a drug or other substance. Such actions are exempt from 
review by the Office of Management and Budget pursuant to Section 
3(d)(1) of Executive Order 12866 and the principles reaffirmed in 
Executive Order 13563.

Executive Order 12988

    This proposed regulation meets the applicable standards set forth 
in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice 
Reform to eliminate ambiguity, minimize litigation, establish clear 
legal standards, and reduce burden.

Executive Order 13132

    This proposed rulemaking does not preempt or modify any provision 
of State law; nor does it impose enforcement responsibilities on any 
State; nor does it diminish the power of any State to enforce its own 
laws. Accordingly, this rulemaking does not have federalism 
implications warranting the application of Executive Order 13132.

Executive Order 13175

    This proposed rule will not have tribal implications and will not 
impose substantial direct compliance costs on Indian tribal 
governments.

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information under 
the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    For the reasons set out above, 21 CFR Part 1308 is proposed to be 
amended to read 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 amended by adding a new paragraph (d)(36) to 
read as follows:

Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *
    (36) 3,4-Methylenedioxy-N-methylcathinone (Methylone)--7540
* * * * *

    Dated: October 10, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-25509 Filed 10-16-12; 8:45 am]
BILLING CODE 4410-09-P
```