63766 Federal Register / Vol. 77, No. 201 / Wednesday, October 17, 2012 / Proposed Rules 

Federal Deposit Insurance Corporation. 

Robert E. Feldman, 

Executive Secretary. 

[FR Doc. 2012–25495 Filed 10–16–12; 8:45 am] 

BILLING CODE 6714–01–P 

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 


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Federal Register / Vol. 77, No. 201 / Wednesday, October 17, 2012 / Proposed Rules 63767 

1On 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. 

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. 

3Comprehensive 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. 

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-Nmethylcathinone (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. 

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 

(b-ketone) substituent to the 

phenethylamine core structure produces 

a group of substances that have b-ketophenethylamine as the core structure. 

Methylone has a b-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. 

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

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. 


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63768 Federal Register / Vol. 77, No. 201 / Wednesday, October 17, 2012 / Proposed Rules 

4AAPCC is a non-profit, national organization 

that represents the poison centers of the United 

States. 

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. 

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 


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Federal Register / Vol. 77, No. 201 / Wednesday, October 17, 2012 / Proposed Rules 63769 

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. 

6State 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. 

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 bketophenethylamine (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 twostep 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. 


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63770 Federal Register / Vol. 77, No. 201 / Wednesday, October 17, 2012 / Proposed Rules 

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-Nmethylcathinone (methylone) has a high 

potential for abuse; 

(2) 3,4-methylenedioxy-Nmethylcathinone (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-Nmethylcathinone (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 


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Federal Register / Vol. 77, No. 201 / Wednesday, October 17, 2012 / Proposed Rules 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: 

§ 1308.11 Schedule I. 

* * * * * 

(d) * * * 

(36) 3,4-Methylenedioxy-Nmethylcathinone (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 

POSTAL SERVICE 

39 CFR Part 111 

Implementation of Full-Service 

Intelligent Mail Requirements for 

Automation Prices 

AGENCY: Postal ServiceTM. 

ACTION: Proposed rule. 

SUMMARY: The Postal Service is 

proposing to revise Mailing Standards 

of the United States Postal Service, 

Domestic Mail Manual (DMM®) 

throughout various sections to modify 

eligibility requirements for mailers to 

obtain automation prices for First-Class 

Mail®, Standard Mail®, Periodicals®, 

and Bound Printed Matter® when 

mailing postcards, letters, and flats. 

Effective January 2014, use of ‘‘fullservice’’ Intelligent Mail® would be 

required to obtain automation prices. 

Additionally, the 10/24 transitional 

barcoded tray label format would be 

eliminated and mailers would be 

required to use the 24-digit Intelligent 

Mail barcode (IMbTM) format on tray, 

tub, and sack labels. 

DATES: We must receive your comments 

on or before November 16, 2012. 

ADDRESSES: Mail or deliver written 

comments to the Manager, Product 

Classification, U.S. Postal Service, 475 

L’Enfant Plaza SW., Room 4446, 

Washington, DC 20260–5015. You may 

inspect and photocopy all written 

comments at USPS® Headquarters 

Library, 475 L’Enfant Plaza SW., 11th 

Floor N., Washington, DC by 

appointment only between the hours of 

9 a.m. and 4 p.m., Monday through 

Friday by calling 1–202–268–2906 in 

advance. Comments and questions can 

also be emailed to 

mailingstandards@usps.gov using the 

subject line ‘‘full-service January 2014.’’ 

FOR FURTHER INFORMATION CONTACT: 

Ana Cikowski, email: 

ana.cikowski@usps.gov, phone: 202– 

268–8079. 

Himesh Patel, email: 

himesh.a.patel@usps.gov, phone: 

703–280–7498. 

William Chatfield, email: 

william.a.chatfield@usps.gov, phone: 

202–268–7278. 

SUPPLEMENTARY INFORMATION: On April 

20, 2012, the Postal Service published 

an advance notice of proposed 

rulemaking in the Federal Register (77 

FR 23643–23647) to require use of fullservice Intelligent Mail to obtain 

automation prices for First-Class Mail 

(FCM), Standard Mail, Periodicals, and 

Bound Printed Matter (BPM) when 

mailing postcards, letters, and flats. 

Background 

In January 2009, the Postal Service 

offered the mailing industry two 

Intelligent Mail options for automation 

discounts: basic-service and full-service. 

Currently, a large number of mailers are 

using these options and reaping 

significant benefits and value. 

When using the full-service option, 

mailers are required to: Apply unique 

Intelligent Mail barcodes (IMb) to 

identify each letter, postcard, and flat 

mailpiece; individually meet the 

eligibility requirements for automation 

prices according to class and shape; 

apply unique Intelligent Mail tray 

barcodes (IMtb) on trays, tubs, and 

sacks; apply unique Intelligent Mail 

container barcodes (IMcb) on placards 

for containers, such as pallets; schedule 

appointments through Facility Access 

and Shipment Tracking (FAST®) if their 

mail is accepted at an origin facility and 

entered at a downstream USPSTM

processing facility; and use an approved 

electronic method to transmit to the 

Postal Service mailing documentation 

and postage statements. If the mailing is 

being prepared or presented on behalf of 


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