Schedules of Controlled Substances: Temporary Placement of Five Synthetic Cannabinoids Into Schedule I, 71635-71638 [2010-29600]
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Federal Register / Vol. 75, No. 226 / Wednesday, November 24, 2010 / Proposed Rules
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and other information in your case
record, we will try to resolve it. * * *
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(Emphasis added). We provide similar
definitions of the terms ‘‘marked’’ and
‘‘extreme’’ in the listings section for
children, with criteria appropriate to
childhood.
Why are we providing a limited
reopening of the public comment
period?
In response to the NPRM, we received
many public comments that seemed to
misunderstand our current policy, what
changes we were proposing, and how
the proposals might affect adults and
children. We believe that much of the
confusion was caused by our failure to
provide sufficiently detailed
information about our current policies
and where our proposals came from. We
apologize for that omission, which we
have corrected in this notice.
Although we received a wide variety
of comments, we are reopening the
public comment period on a limited
basis to specifically address the
misunderstanding of our current and
proposed policy regarding the use of
standardized tests. We are requesting
public comment only on this issue in
light of the clarification we are
providing in this notice.
Many commenters focused on two
aspects of our proposed rule: (1) A
definition of ‘‘marked’’ based on a
standardized test score that is two
standard deviations below the mean;
and, (2) a separate definition of
‘‘marked’’ based on functioning that
would be the equivalent of such a score
if there were a standardized test. As
discussed above, neither of these
proposals represents new policy; both
are based on our longstanding rules.
However, some commenters said that
our proposal would encourage our
adjudicators to use standardized tests.
Many said that we should drop all
reference to standardized tests in the
mental illness sections of the proposed
rules and that the change would reduce
the number of children and adults with
serious mental disorders who qualify for
disability benefits. Some who are
already beneficiaries or who have family
members who are beneficiaries were
concerned that they would lose their
benefits.
We did not intend for, and do not
believe that, our proposed rules would
do any of these things. The childhood
mental disorders listings have contained
a provision defining ‘‘marked’’ limitation
as a score that is two standard
deviations below the mean on a
standardized test for 20 years. We
developed those rules with information
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we received from a group of mental
health experts. We did not propose to
change that provision or the way we
determine disability in children with
serious mental disorders. We proposed
only to extend the provision to adults
since it has worked well in childhood
claims.
The proposed rules for adults and
children do not state that adjudicators
should obtain standardized tests,
encourage them to do so, or indicate
that there are standardized tests for all
serious mental disorders. Rather, our
proposed rules state only that if a person
has a standardized test and the scores
are two standard deviations below the
mean, the test will show that the person
has a ‘‘marked’’ limitation. Consistent
with our current childhood rules, the
proposed rules also state that
adjudicators must not rely on the results
of standardized tests alone but must
consider all of the evidence in the
person’s case record.
Since the beginning of 2001, our
functional equivalence regulation has
contained an alternative rule defining
‘‘marked’’ limitation for children based
on functioning that would be consistent
with a score on a standardized test that
is two standard deviations below the
mean, if there were such a test. As with
the provision for actual scores from an
actual test, the rule provides that we
will find that the child has a marked
limitation if the child is functioning at
that level. The regulation section, like
the proposed rule for the mental
disorders listings, also provides other
definitions for the term ‘‘marked.’’ We
began using this regulation in 1997, 13
years ago. The number of awards of
children who apply for SSI has not
fallen since that time.13 Given this
experience, we believe that it was
appropriate to include the rule in both
the adult and child mental disorders
listings.
Perhaps most importantly, it appeared
that many commenters did not
understand that we do not deny a
person’s claim merely because his or her
impairment(s) does not meet or
medically equal the criteria of our
listings. As under our current rules,
adults with mental disorders who
cannot perform their past work or a
significant number of jobs in the
national economy considering their age,
education, and work experience would
still be able to qualify under other rules
we have for finding persons disabled.
13 You may look up our award data for children
under SSI by year in the SSI Annual Statistical
Report, available at: https://www.socialsecurity.gov/
policy/docs/statcomps/ssi_asr/2009/ssi_asr09.pdf.
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We also want to make clear that we
do not reexamine the entitlement of
beneficiaries when we revise listings.
When we periodically perform
continuing disability reviews to
determine if beneficiaries are still
disabled, we continue to use the same
listing section we used to make our
most recent favorable decision.14 Thus,
beneficiaries who qualified under a
current listing would continue to
qualify as long as their impairments
continued to meet or medically equal
the current listing.
In light of the importance of this issue
and the widespread misunderstanding
of our proposed rules, we are reopening
the comment period for the limited
purpose of allowing interested persons
to provide any additional comments
they may have on our proposed policy
regarding the use of standardized tests.
Michael J. Astrue,
Commissioner of Social Security.
[FR Doc. 2010–29577 Filed 11–23–10; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–345N]
Schedules of Controlled Substances:
Temporary Placement of Five
Synthetic Cannabinoids Into
Schedule I
Drug Enforcement
Administration (DEA), U.S. Department
of Justice.
ACTION: Notice of Intent.
AGENCY:
The Deputy Administrator of
the Drug Enforcement Administration
(DEA) is issuing this notice of intent to
temporarily place five synthetic
cannabinoids into the Controlled
Substances Act (CSA) pursuant to the
temporary scheduling provisions under
21 U.S.C. 811(h) of the CSA. The
substances are 1-pentyl-3-(1naphthoyl)indole (JWH–018), 1-butyl-3(1-naphthoyl)indole (JWH–073), 1-[2-(4morpholinyl)ethyl]-3-(1naphthoyl)indole (JWH–200), 5-(1,1dimethylheptyl)-2-[(1R,3S)-3hydroxycyclohexyl]-phenol (CP–
47,497), and 5-(1,1-dimethyloctyl)-2[(1R,3S)-3-hydroxycyclohexyl]-phenol
(cannabicyclohexanol; CP–47,497 C8
homologue). This intended action is
based on a finding by the DEA Deputy
SUMMARY:
14 See 404.1594(c)(3)(i), 416.994(b)(2)(iv)(A), and
416.994a(b)(2).
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Administrator that the placement of
these synthetic cannabinoids into
Schedule I of the CSA is necessary to
avoid an imminent hazard to the public
safety. Finalization of this action will
impose criminal sanctions and
regulatory controls of Schedule I
substances under the CSA on the
manufacture, distribution, possession,
importation, and exportation of these
synthetic cannabinoids.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, Ph.D., Chief,
Drug and Chemical Evaluation Section,
Office of Diversion Control, Drug
Enforcement Administration, 8701
Morrissette Drive, Springfield, VA
22152, telephone (202) 307–7183, fax
(202) 353–1263, or e-mail
ode@dea.usdoj.gov.
SUPPLEMENTARY INFORMATION:
Background
The Comprehensive Crime Control
Act of 1984 (Pub. L. 98–473), which was
signed into law on October 12, 1984,
amended section 201 of the CSA (21
U.S.C. 811) to give the Attorney General
the authority to temporarily place a
substance into Schedule I of the CSA for
one year without regard to the
requirements of 21 U.S.C. 811(b) if he
finds that such action is necessary to
avoid imminent hazard to the public
safety. The Attorney General may
extend the temporary scheduling up to
six months. A substance may be
temporarily scheduled under the
emergency provisions of the CSA if it is
not listed in any other schedule under
section 202 of the CSA (21 U.S.C. 812)
or if there is no exemption or approval
in effect under 21 U.S.C. 355 for the
substance. The Attorney General has
delegated his authority under 21 U.S.C.
811 to the Administrator of DEA (28
CFR 0.100). The Administrator has
redelegated this function to the Deputy
Administrator, pursuant to 28 CFR,
appendix to subpart R, section 12.
Section 201(h)(4) of the CSA (21
U.S.C. 811(h)(4)) requires the Deputy
Administrator to notify the Assistant
Secretary for Health, delegate of the
Secretary of Health and Human
Services, of her intention to temporarily
place a substance into Schedule I of the
CSA. Comments submitted by the
Assistant Secretary for Health in
response to this notification, including
whether there is an exemption or
approval in effect for the substance in
question under the Federal Food, Drug
and Cosmetic Act, shall be taken into
consideration before a final order is
published.
In making a finding that placing a
substance temporarily into Schedule I of
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the CSA is necessary to avoid an
imminent hazard to the public safety,
the Deputy Administrator is required to
consider three of the eight factors set
forth in section 201(c) of the CSA (21
U.S.C. 811(c)). These factors are as
follows: (4) History and current pattern
of abuse; (5) The scope, duration and
significance of abuse; and (6) What, if
any, risk there is to the public health.
Synthetic Cannabinoids
Synthetic cannabinoids have been
developed over the last 30 years for
research purposes to investigate the
cannabinoid system. No legitimate nonresearch uses have been identified for
these synthetic cannabinoids. They have
not been approved by the U.S. Food and
Drug Administration for human
consumption. These THC-like synthetic
cannabinoids, 1-pentyl-3-(1naphthoyl)indole (JWH–018), 1-butyl-3(1-naphthoyl)indole (JWH–073), 1-[2-(4morpholinyl)ethyl]-3-(1naphthoyl)indole (JWH–200), 5-(1,1dimethylheptyl)-2-[(1R,3S)-3hydroxycyclohexyl]-phenol (CP–
47,497), and 5-(1,1-dimethyloctyl)-2[(1R,3S)-3-hydroxycyclohexyl]-phenol
(cannabicyclohexanol; CP–47,497 C8
homologue), are so termed for their
THC-like pharmacological properties.
Though they have similar properties to
delta-9-tetrahydrocannabinol (THC)
found in marijuana and have been
found to be more potent than THC in
animal studies. Numerous herbal
products have been analyzed and JWH–
073, JWH–018, JWH–200, CP–47,497,
and cannabicyclohexanol have been
identified in varying mixture profiles
and amounts spiked on plant material.
Factor 4. History and Current Pattern of
Abuse
The emergence of these synthetic
cannabinoids represents a recent
phenomenon in the designer drug
market. Since the initial identification
of JWH–018 in December 2008, many
additional synthetic cannabinoids with
purported psychotropic effects have
been identified in related products. The
popularity of these THC-like synthetic
cannabinoids has greatly increased in
the United States and they are being
abused for their psychoactive
properties. Primarily found laced on
plant material, these synthetic
cannabinoids are also being abused
alone as self-reported on Internet
discussion boards. This abuse has been
characterized by both acute and long
term public health and safety problems.
Even though there is no accepted use for
these synthetic cannabinoids, multiple
shipments of JWH–018 and JWH–073
have been intercepted by U.S. Customs
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and Border Protection in 2010, with one
being in excess of 50 kilograms.
Additionally, bulk loads of JWH–018
and JWH–200 have been seized by law
enforcement in 2010. In Casper,
Wyoming, products seized in a raid,
which were laced with synthetic
cannabinoids, were found in
conjunction with illicit drugs.
The products containing these THClike synthetic cannabinoids are
marketed as ‘‘legal’’ alternatives to
marijuana and are being sold over the
Internet and in tobacco and smoke
shops, drug paraphernalia shops, and
convenience stores. These synthetic
cannabinoids alone or spiked on plant
material have the potential to be
extremely harmful due to their method
of manufacture and high
pharmacological potency. DEA has been
made aware that smoking these
synthetic cannabinoids for the purpose
of achieving intoxication and
experiencing the psychoactive effects is
identified as a reason for emergency
room visits and calls to poison control
centers.
As of October 15, 2010, 15 states in
the United States, European and
Scandinavian countries have controlled
one or more of the synthetic
cannabinoids DEA is temporarily
scheduling here.
Factor 5. Scope, Duration and
Significance of Abuse
According to forensic laboratory
reports, the first appearance of these
synthetic cannabinoids in the United
States occurred in November 2008,
when U.S. Customs and Border
Protection analyzed ‘‘Spice’’ products.
From January 2010 through September
2010, the National Forensic Laboratory
Information System, a national
repository of drug evidence analyses
from forensic laboratories across the
United States, reported over 500
exhibits relating to these synthetic
cannabinoids from various States
including Alabama, Arkansas,
California, Florida, Hawaii, Iowa,
Indiana, Kansas, Kentucky, Louisiana,
Minnesota, Missouri, North Dakota,
Nebraska, Nevada, Oklahoma,
Pennsylvania, South Carolina,
Tennessee, and Virginia. Additionally,
the American Association of Poison
Control Centers (AAPCC) has reported
receiving over 1,500 calls as of
September 27, 2010, relating to products
spiked with these synthetic
cannabinoids from 48 states and the
District of Columbia.
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Factor 6. What, if Any, Risk There Is to
the Public Health
JWH–018, JWH–073, JWH–200, CP–
47,497, and cannabicyclohexanol share
pharmacological similarities with the
Schedule I substance THC. Health
warnings have been issued by numerous
state public health departments and
poison control centers describing the
adverse health effects associated with
these synthetic cannabinoids and their
related products including agitation,
anxiety, vomiting, tachycardia, elevated
blood pressure, seizures, hallucinations
and non-responsiveness. Case reports
describe psychotic episodes,
withdrawal, and dependence associated
with use of these synthetic
cannabinoids, similar to syndromes
observed in cannabis abuse. Emergency
room physicians have reported
admissions connected to the abuse of
these synthetic cannabinoids.
Additionally, when responding to
incidents involving individuals who
have reportedly smoked these synthetic
cannabinoids, first responders report
that these individuals suffer from
intense hallucinations. Detailed
chemical analysis by DEA and other
investigators have found these synthetic
cannabinoids spiked on plant material
in products marketed to the general
public. The risk of adverse health effects
is further increased by the fact that
similar products vary in the
composition and concentration of
synthetic cannabinoids(s) spiked on the
plant material.
Self-reported abuse of these THC-like
synthetic cannabinoids alone and
spiked on plant material appear on
Internet discussion boards. According to
self-reports, these substances are
cannabis-like (or THC-like) in their
psychoactive effects and are more
potent than THC in this regard. The
most common route of administration of
these synthetic cannabinoids is by
smoking, using a pipe, water pipe, or
rolling the drug-spiked plant material in
cigarette papers.
The marketing of products that
contain one or more of these synthetic
cannabinoids is geared towards teens
and young adults. Despite disclaimers
that the products are not intended for
human consumption, retailers promote
that routine urinalysis tests will not
typically detect the presence of these
synthetic cannabinoids.
Furthermore, a number of the
products and synthetic cannabinoids
appear to originate from foreign sources
and are manufactured in the absence of
quality controls and devoid of
regulatory oversight. These products
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and associated synthetic cannabinoids
are readily accessible via the Internet.
DEA has considered the three criteria
for placing a substance into Schedule I
of the CSA (21 U.S.C. 812). The data
available and reviewed for JWH–073,
JWH–018, JWH–200, CP–47,497, and
cannabicyclohexanol indicate that these
synthetic cannabinoids each have a high
potential for abuse, no currently
accepted medical use in treatment in the
United States and are not safe for use
under medical supervision.
Based on the above data, the
continued uncontrolled manufacture,
distribution, importation, exportation,
and abuse of JWH–018, JWH–073, JWH–
200, CP–47,497, and
cannabicyclohexanol pose an imminent
hazard to the public safety. DEA is not
aware of any recognized therapeutic
uses of these synthetic cannabinoids in
the United States. As required by
section 201(h)(4) of the CSA (21 U.S.C.
811(h)), the Deputy Administrator in a
letter dated October 6, 2010, notified the
Assistant Secretary of Health of the
intention to temporarily place five
synthetic cannabinoids in Schedule I.
In accordance with the provisions of
section 201(h) of the CSA (21 U.S.C.
811(h)) and 28 CFR 0.100, the Deputy
Administrator has considered the
available data and the three factors
required to support a determination to
temporarily schedule five synthetic
cannabinoids: 1-butyl-3-(1naphthoyl)indole, 1-pentyl-3-(1naphthoyl)indole, 1-[2-(4morpholinyl)ethyl]-3-(1naphthoyl)indole, 5-(1,1dimethylheptyl)-2-[(1R,3S)-3hydroxycyclohexyl]-phenol, and 5-(1,1dimethyloctyl)-2-[(1R,3S)-3hydroxycyclohexyl]-phenol in Schedule
I of the CSA and finds that placement
of these synthetic cannabinoids into
Schedule I of the CSA is necessary to
avoid an imminent hazard to the public
safety.
Because the Deputy Administrator
finds that it is necessary to temporarily
place these synthetic cannabinoids into
Schedule I to avoid an imminent hazard
to the public safety, the final order, if
issued, will be effective on the date of
publication of the order in the Federal
Register. JWH–018, JWH–073, JWH–
200, CP–47,497, and
cannabicyclohexanol will be subject to
the regulatory controls and
administrative, civil and criminal
sanctions applicable to the manufacture,
distribution, possession, importing and
exporting of a Schedule I controlled
substance under the CSA. Further, it is
the intention of the Deputy
Administrator to issue such a final order
as soon as possible after the expiration
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of thirty days from the date of
publication of this notice and the date
that notification was transmitted to the
Assistant Secretary for Health.
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Administrator hereby
certifies that this rulemaking has been
drafted in accordance with the
Regulatory Flexibility Act (5 U.S.C.
601–612), has reviewed this regulation,
and by approving it certifies that this
regulation will not have a significant
economic impact on a substantial
number of small entities. This action
provides a notice of intent to
temporarily place 1-butyl-3-(1naphthoyl)indole, 1-pentyl-3-(1naphthoyl)indole, 1-[2-(4morpholinyl)ethyl]-3-(1naphthoyl)indole, 5-(1,1dimethylheptyl)-2-[(1R,3S)-3hydroxycyclohexyl]-phenol, and 5-(1,1dimethyloctyl)-2-[(1R,3S)-3hydroxycyclohexyl]-phenol into
Schedule I of the CSA. DEA is not aware
of any legitimate non-research uses for
these synthetic cannabinoids in the
United States.
Executive Order 12988
This regulation meets the applicable
standards set forth in Sections 3(a) and
3(b)(2) of Executive Order 12988 Civil
Justice Reform.
Executive Order 13132
This 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.
Unfunded Mandates Reform Act of 1995
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
(adjusting for inflation) in any one year,
and it will not significantly or uniquely
affect small governments. Therefore, no
actions were deemed necessary under
the provisions of the Unfunded
Mandates Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as
defined by 804 of the Small Business
Regulatory Enforcement Fairness Act of
1996 (Congressional Review Act). This
rule will not result in an annual effect
on the economy of $100,000,000 or
more; a major increase in costs or prices;
or significant adverse effects on
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competition, employment, investment,
productivity, innovation, or on the
ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.
DEPARTMENT OF HOMELAND
SECURITY
List of Subjects in 21 CFR Part 1308
[Docket No. USCG–2010–0062]
Administrative practice and
procedure, Drug traffic control,
Reporting and recordkeeping
requirements.
RIN 1625–AA00
Under the authority vested in the
Attorney General by section 201(h) of
the CSA (21 U.S.C. 811(h)), and
delegated to the Deputy Administrator
of the DEA by Department of Justice
regulations (28 CFR 0.100, and section
12 of the Appendix to Subpart R), the
Deputy Administrator hereby intends to
order that 21 CFR part 1308 be amended
as follows:
AGENCY:
33 CFR Part 165
Safety Zone; Fleet Week Maritime
Festival, Pier 66, Elliot Bay, Seattle,
WA
Coast Guard, DHS.
Supplemental notice of
proposed rulemaking.
ACTION:
[FR Doc. 2010–29600 Filed 11–23–10; 8:45 am]
The Coast Guard proposes to
amend its regulation establishing a
permanent safety zone extending 100
yards from Pier 66, Elliot Bay, WA to
ensure adequate safety during the
parade of ships and aerial
demonstration for Fleet Week. This
supplemental notice of proposed
rulemaking introduces revisions to
enforcement dates, times and location of
this safety zone. This safety zone is
necessary in order to restrict vessel
movement for participant and spectator
safety in the proximity of Pier 66, Elliot
Bay, WA to provide unencumbered
access for response craft in the event of
an emergency during the annual parade
of ships and aerial demonstration.
DATES: Comments and related material
must be received by the Coast Guard on
or before December 27, 2010.
ADDRESSES: You may submit comments
identified by docket number USCG–
2010–0062 using any one of the
following methods:
(1) Federal eRulemaking Portal:
https://www.regulations.gov.
(2) Fax: 202–493–2251.
(3) Mail: Docket Management Facility
(M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue, SE., Washington, DC 20590–
0001.
(4) Hand Delivery: Same as mail
address above, between 9 a.m. and
5 p.m., Monday through Friday, except
Federal holidays. The telephone number
is 202–366–9329.
To avoid duplication, please use only
one of these four methods. See the
‘‘Public Participation and Request for
Comments’’ portion of the
SUPPLEMENTARY INFORMATION section
below for instructions on submitting
comments.
BILLING CODE 4410–09–P
FOR FURTHER INFORMATION CONTACT:
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
1. The authority citation for 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 new paragraphs (g)(1), (2), (3),
(4), and (5) to read as follows:
§ 1308.11
Schedule I.
*
*
*
*
*
(g) * * *
(1) 5-(1,1-Dimethylheptyl)-2-[(1R,3S)3-hydroxycyclohexyl]-phenol-7297
(Other names: CP-47,497)
(2) 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3hydroxycyclohexyl]-phenol-7298
(Other names: cannabicyclohexanol
and CP-47,497 C8 homologue)
(3) 1-Butyl-3-(1-naphthoyl)indole7173
(Other names: JWH-073)
(4) 1-[2-(4-Morpholinyl)ethyl]-3-(1naphthoyl)indole-7200
(Other names: JWH-200)
(5) 1-Pentyl-3-(1-naphthoyl)indole7118
(Other names: JWH-018 and AM678)
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Coast Guard
Dated: November 15, 2010.
Michele M. Leonhart,
Deputy Administrator.
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SUMMARY:
If
you have questions on this proposed
rule, call or e-mail LTJG Ashley M.
Wanzer, Sector Puget Sound Waterways
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Management Division, Coast Guard;
telephone 206–217–6175, e-mail
SectorSeattleWWM@uscg.mil. If you
have questions on viewing or submitting
material to the docket, call Renee V.
Wright, Program Manager, Docket
Operations, telephone 202–366–9826.
SUPPLEMENTARY INFORMATION:
Public Participation and Request for
Comments
We encourage you to participate in
this rulemaking by submitting
comments and related materials. All
comments received will be posted
without change to https://
www.regulations.gov and will include
any personal information you have
provided.
Submitting Comments
If you submit a comment, please
include the docket number for this
rulemaking (USCG–2010–0062),
indicate the specific section of this
document to which each comment
applies, and provide a reason for each
suggestion or recommendation. You
may submit your comments and
material online (via https://
www.regulations.gov) or by fax, mail, or
hand delivery, but please use only one
of these means. If you submit a
comment online via https://
www.regulations.gov, it will be
considered received by the Coast Guard
when you successfully transmit the
comment. If you fax, hand deliver, or
mail your comment, it will be
considered as having been received by
the Coast Guard when it is received at
the Docket Management Facility. We
recommend that you include your name
and a mailing address, an e-mail
address, or a telephone number in the
body of your document so that we can
contact you if we have questions
regarding your submission.
To submit your comment online, go to
https://www.regulations.gov, click on the
‘‘submit a comment’’ box, which will
then become highlighted in blue. In the
‘‘Document Type’’ drop down menu
select ‘‘Proposed Rule’’ and insert
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If you submit your comments by mail or
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E:\FR\FM\24NOP1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 226 (Wednesday, November 24, 2010)]
[Proposed Rules]
[Pages 71635-71638]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29600]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-345N]
Schedules of Controlled Substances: Temporary Placement of Five
Synthetic Cannabinoids Into Schedule I
AGENCY: Drug Enforcement Administration (DEA), U.S. Department of
Justice.
ACTION: Notice of Intent.
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SUMMARY: The Deputy Administrator of the Drug Enforcement
Administration (DEA) is issuing this notice of intent to temporarily
place five synthetic cannabinoids into the Controlled Substances Act
(CSA) pursuant to the temporary scheduling provisions under 21 U.S.C.
811(h) of the CSA. The substances are 1-pentyl-3-(1-naphthoyl)indole
(JWH-018), 1-butyl-3-(1-naphthoyl)indole (JWH-073), 1-[2-(4-
morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200), 5-(1,1-
dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP-47,497), and
5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol
(cannabicyclohexanol; CP-47,497 C8 homologue). This intended action is
based on a finding by the DEA Deputy
[[Page 71636]]
Administrator that the placement of these synthetic cannabinoids into
Schedule I of the CSA is necessary to avoid an imminent hazard to the
public safety. Finalization of this action will impose criminal
sanctions and regulatory controls of Schedule I substances under the
CSA on the manufacture, distribution, possession, importation, and
exportation of these synthetic cannabinoids.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, 8701 Morrissette Drive, Springfield, VA
22152, telephone (202) 307-7183, fax (202) 353-1263, or e-mail
ode@dea.usdoj.gov.
SUPPLEMENTARY INFORMATION:
Background
The Comprehensive Crime Control Act of 1984 (Pub. L. 98-473), which
was signed into law on October 12, 1984, amended section 201 of the CSA
(21 U.S.C. 811) to give the Attorney General the authority to
temporarily place a substance into Schedule I of the CSA for one year
without regard to the requirements of 21 U.S.C. 811(b) if he finds that
such action is necessary to avoid imminent hazard to the public safety.
The Attorney General may extend the temporary scheduling up to six
months. A substance may be temporarily scheduled under the emergency
provisions of the CSA if it is not listed in any other schedule under
section 202 of the CSA (21 U.S.C. 812) or if there is no exemption or
approval in effect under 21 U.S.C. 355 for the substance. The Attorney
General has delegated his authority under 21 U.S.C. 811 to the
Administrator of DEA (28 CFR 0.100). The Administrator has redelegated
this function to the Deputy Administrator, pursuant to 28 CFR, appendix
to subpart R, section 12.
Section 201(h)(4) of the CSA (21 U.S.C. 811(h)(4)) requires the
Deputy Administrator to notify the Assistant Secretary for Health,
delegate of the Secretary of Health and Human Services, of her
intention to temporarily place a substance into Schedule I of the CSA.
Comments submitted by the Assistant Secretary for Health in response to
this notification, including whether there is an exemption or approval
in effect for the substance in question under the Federal Food, Drug
and Cosmetic Act, shall be taken into consideration before a final
order is published.
In making a finding that placing a substance temporarily into
Schedule I of the CSA is necessary to avoid an imminent hazard to the
public safety, the Deputy Administrator is required to consider three
of the eight factors set forth in section 201(c) of the CSA (21 U.S.C.
811(c)). These factors are as follows: (4) History and current pattern
of abuse; (5) The scope, duration and significance of abuse; and (6)
What, if any, risk there is to the public health.
Synthetic Cannabinoids
Synthetic cannabinoids have been developed over the last 30 years
for research purposes to investigate the cannabinoid system. No
legitimate non-research uses have been identified for these synthetic
cannabinoids. They have not been approved by the U.S. Food and Drug
Administration for human consumption. These THC-like synthetic
cannabinoids, 1-pentyl-3-(1-naphthoyl)indole (JWH-018), 1-butyl-3-(1-
naphthoyl)indole (JWH-073), 1-[2-(4-morpholinyl)ethyl]-3-(1-
naphthoyl)indole (JWH-200), 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-
hydroxycyclohexyl]-phenol (CP-47,497), and 5-(1,1-dimethyloctyl)-2-
[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol; CP-47,497 C8
homologue), are so termed for their THC-like pharmacological
properties. Though they have similar properties to delta-9-
tetrahydrocannabinol (THC) found in marijuana and have been found to be
more potent than THC in animal studies. Numerous herbal products have
been analyzed and JWH-073, JWH-018, JWH-200, CP-47,497, and
cannabicyclohexanol have been identified in varying mixture profiles
and amounts spiked on plant material.
Factor 4. History and Current Pattern of Abuse
The emergence of these synthetic cannabinoids represents a recent
phenomenon in the designer drug market. Since the initial
identification of JWH-018 in December 2008, many additional synthetic
cannabinoids with purported psychotropic effects have been identified
in related products. The popularity of these THC-like synthetic
cannabinoids has greatly increased in the United States and they are
being abused for their psychoactive properties. Primarily found laced
on plant material, these synthetic cannabinoids are also being abused
alone as self-reported on Internet discussion boards. This abuse has
been characterized by both acute and long term public health and safety
problems. Even though there is no accepted use for these synthetic
cannabinoids, multiple shipments of JWH-018 and JWH-073 have been
intercepted by U.S. Customs and Border Protection in 2010, with one
being in excess of 50 kilograms. Additionally, bulk loads of JWH-018
and JWH-200 have been seized by law enforcement in 2010. In Casper,
Wyoming, products seized in a raid, which were laced with synthetic
cannabinoids, were found in conjunction with illicit drugs.
The products containing these THC-like synthetic cannabinoids are
marketed as ``legal'' alternatives to marijuana and are being sold over
the Internet and in tobacco and smoke shops, drug paraphernalia shops,
and convenience stores. These synthetic cannabinoids alone or spiked on
plant material have the potential to be extremely harmful due to their
method of manufacture and high pharmacological potency. DEA has been
made aware that smoking these synthetic cannabinoids for the purpose of
achieving intoxication and experiencing the psychoactive effects is
identified as a reason for emergency room visits and calls to poison
control centers.
As of October 15, 2010, 15 states in the United States, European
and Scandinavian countries have controlled one or more of the synthetic
cannabinoids DEA is temporarily scheduling here.
Factor 5. Scope, Duration and Significance of Abuse
According to forensic laboratory reports, the first appearance of
these synthetic cannabinoids in the United States occurred in November
2008, when U.S. Customs and Border Protection analyzed ``Spice''
products. From January 2010 through September 2010, the National
Forensic Laboratory Information System, a national repository of drug
evidence analyses from forensic laboratories across the United States,
reported over 500 exhibits relating to these synthetic cannabinoids
from various States including Alabama, Arkansas, California, Florida,
Hawaii, Iowa, Indiana, Kansas, Kentucky, Louisiana, Minnesota,
Missouri, North Dakota, Nebraska, Nevada, Oklahoma, Pennsylvania, South
Carolina, Tennessee, and Virginia. Additionally, the American
Association of Poison Control Centers (AAPCC) has reported receiving
over 1,500 calls as of September 27, 2010, relating to products spiked
with these synthetic cannabinoids from 48 states and the District of
Columbia.
[[Page 71637]]
Factor 6. What, if Any, Risk There Is to the Public Health
JWH-018, JWH-073, JWH-200, CP-47,497, and cannabicyclohexanol share
pharmacological similarities with the Schedule I substance THC. Health
warnings have been issued by numerous state public health departments
and poison control centers describing the adverse health effects
associated with these synthetic cannabinoids and their related products
including agitation, anxiety, vomiting, tachycardia, elevated blood
pressure, seizures, hallucinations and non-responsiveness. Case reports
describe psychotic episodes, withdrawal, and dependence associated with
use of these synthetic cannabinoids, similar to syndromes observed in
cannabis abuse. Emergency room physicians have reported admissions
connected to the abuse of these synthetic cannabinoids. Additionally,
when responding to incidents involving individuals who have reportedly
smoked these synthetic cannabinoids, first responders report that these
individuals suffer from intense hallucinations. Detailed chemical
analysis by DEA and other investigators have found these synthetic
cannabinoids spiked on plant material in products marketed to the
general public. The risk of adverse health effects is further increased
by the fact that similar products vary in the composition and
concentration of synthetic cannabinoids(s) spiked on the plant
material.
Self-reported abuse of these THC-like synthetic cannabinoids alone
and spiked on plant material appear on Internet discussion boards.
According to self-reports, these substances are cannabis-like (or THC-
like) in their psychoactive effects and are more potent than THC in
this regard. The most common route of administration of these synthetic
cannabinoids is by smoking, using a pipe, water pipe, or rolling the
drug-spiked plant material in cigarette papers.
The marketing of products that contain one or more of these
synthetic cannabinoids is geared towards teens and young adults.
Despite disclaimers that the products are not intended for human
consumption, retailers promote that routine urinalysis tests will not
typically detect the presence of these synthetic cannabinoids.
Furthermore, a number of the products and synthetic cannabinoids
appear to originate from foreign sources and are manufactured in the
absence of quality controls and devoid of regulatory oversight. These
products and associated synthetic cannabinoids are readily accessible
via the Internet.
DEA has considered the three criteria for placing a substance into
Schedule I of the CSA (21 U.S.C. 812). The data available and reviewed
for JWH-073, JWH-018, JWH-200, CP-47,497, and cannabicyclohexanol
indicate that these synthetic cannabinoids each have a high potential
for abuse, no currently accepted medical use in treatment in the United
States and are not safe for use under medical supervision.
Based on the above data, the continued uncontrolled manufacture,
distribution, importation, exportation, and abuse of JWH-018, JWH-073,
JWH-200, CP-47,497, and cannabicyclohexanol pose an imminent hazard to
the public safety. DEA is not aware of any recognized therapeutic uses
of these synthetic cannabinoids in the United States. As required by
section 201(h)(4) of the CSA (21 U.S.C. 811(h)), the Deputy
Administrator in a letter dated October 6, 2010, notified the Assistant
Secretary of Health of the intention to temporarily place five
synthetic cannabinoids in Schedule I.
In accordance with the provisions of section 201(h) of the CSA (21
U.S.C. 811(h)) and 28 CFR 0.100, the Deputy Administrator has
considered the available data and the three factors required to support
a determination to temporarily schedule five synthetic cannabinoids: 1-
butyl-3-(1-naphthoyl)indole, 1-pentyl-3-(1-naphthoyl)indole, 1-[2-(4-
morpholinyl)ethyl]-3-(1-naphthoyl)indole, 5-(1,1-dimethylheptyl)-2-
[(1R,3S)-3-hydroxycyclohexyl]-phenol, and 5-(1,1-dimethyloctyl)-2-
[(1R,3S)-3-hydroxycyclohexyl]-phenol in Schedule I of the CSA and finds
that placement of these synthetic cannabinoids into Schedule I of the
CSA is necessary to avoid an imminent hazard to the public safety.
Because the Deputy Administrator finds that it is necessary to
temporarily place these synthetic cannabinoids into Schedule I to avoid
an imminent hazard to the public safety, the final order, if issued,
will be effective on the date of publication of the order in the
Federal Register. JWH-018, JWH-073, JWH-200, CP-47,497, and
cannabicyclohexanol will be subject to the regulatory controls and
administrative, civil and criminal sanctions applicable to the
manufacture, distribution, possession, importing and exporting of a
Schedule I controlled substance under the CSA. Further, it is the
intention of the Deputy Administrator to issue such a final order as
soon as possible after the expiration of thirty days from the date of
publication of this notice and the date that notification was
transmitted to the Assistant Secretary for Health.
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this rulemaking has
been drafted in accordance with the Regulatory Flexibility Act (5
U.S.C. 601-612), has reviewed this regulation, and by approving it
certifies that this regulation will not have a significant economic
impact on a substantial number of small entities. This action provides
a notice of intent to temporarily place 1-butyl-3-(1-naphthoyl)indole,
1-pentyl-3-(1-naphthoyl)indole, 1-[2-(4-morpholinyl)ethyl]-3-(1-
naphthoyl)indole, 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-
hydroxycyclohexyl]-phenol, and 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-
hydroxycyclohexyl]-phenol into Schedule I of the CSA. DEA is not aware
of any legitimate non-research uses for these synthetic cannabinoids in
the United States.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Reform.
Executive Order 13132
This 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.
Unfunded Mandates Reform Act of 1995
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 (adjusting for inflation) in any one year, and it
will not significantly or uniquely affect small governments. Therefore,
no actions were deemed necessary under the provisions of the Unfunded
Mandates Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as defined by 804 of the Small
Business Regulatory Enforcement Fairness Act of 1996 (Congressional
Review Act). This rule will not result in an annual effect on the
economy of $100,000,000 or more; a major increase in costs or prices;
or significant adverse effects on
[[Page 71638]]
competition, employment, investment, productivity, innovation, or on
the ability of United States-based companies to compete with foreign-
based companies in domestic and export markets.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
Under the authority vested in the Attorney General by section
201(h) of the CSA (21 U.S.C. 811(h)), and delegated to the Deputy
Administrator of the DEA by Department of Justice regulations (28 CFR
0.100, and section 12 of the Appendix to Subpart R), the Deputy
Administrator hereby intends to order that 21 CFR part 1308 be amended
as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
1. The authority citation for 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 new paragraphs (g)(1), (2),
(3), (4), and (5) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(g) * * *
(1) 5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol-
7297
(Other names: CP-47,497)
(2) 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol-
7298
(Other names: cannabicyclohexanol and CP-47,497 C8 homologue)
(3) 1-Butyl-3-(1-naphthoyl)indole-7173
(Other names: JWH-073)
(4) 1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole-7200
(Other names: JWH-200)
(5) 1-Pentyl-3-(1-naphthoyl)indole-7118
(Other names: JWH-018 and AM678)
Dated: November 15, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-29600 Filed 11-23-10; 8:45 am]
BILLING CODE 4410-09-P
