Schedules of Controlled Substances: Placement of 10 Specific Fentanyl-Related Substances in Schedule I
| Published date | 03 March 2021 |
| Citation | 86 FR 12296 |
| Record Number | 2021-04214 |
| Section | Proposed rules |
| Court | Drug Enforcement Administration |
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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Proposed Rules
For the reasons discussed, I certify
this proposed regulation:
(1) Is not a ‘‘significant regulatory
action’’ under Executive Order 12866,
(2) Would not affect intrastate
aviation in Alaska, and
(3) Would not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
The Proposed Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA proposes to amend 14 CFR part
39 as follows:
PART 39—AIRWORTHINESS
DIRECTIVES
■1. The authority citation for part 39
continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13 [Amended]
■2. The FAA amends § 39.13 by adding
the following new airworthiness
directive:
Airbus Helicopters Deutschland GmbH
(AHD): Docket No. FAA–2021–0126;
Project Identifier MCAI–2020–00266–R.
(a) Comments Due Date
The FAA must receive comments on this
airworthiness directive (AD) by April 19,
2021.
(b) Affected ADs
None.
(c) Applicability
This airworthiness directive (AD) applies
to Airbus Helicopters Deutschland GmbH
(AHD) Model MBB–BK 117 D–2 helicopters,
certificated in any category, with a Titanium
(Ti) bolt part number EN3740–060022F
marked with manufacturer monogram ‘‘D’’ or
with an illegible manufacturer monogram,
installed on the aft connection of the tail
rotor ball bearing control.
(d) Subject
Joint Aircraft System Component (JASC)
Codes: 1430, Fasteners; and 6720, Tail Rotor
Control System.
(e) Unsafe Condition
This AD defines the unsafe condition as a
Ti-bolt with hydrogen embrittlement. This
condition could result in failure of the tail
rotor ball bearing control Ti-bolt and
subsequent loss of tail rotor control.
(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
(g) Required Actions
(1) Within 50 hours time-in-service or 3
months, whichever occurs first, remove any
Ti-bolt identified in paragraph (c) of this AD,
located on the aft connection of the tail rotor
ball bearing rod end (item 5) and at the input
lever (item 2) as shown in Figure 1 to Airbus
Helicopters Alert Service Bulletin (ASB) No.
ASB MBB–BK117 D–2–00A–001, Revision 1,
dated October 16, 2019, from service.
(2) As of the effective date of this AD, do
not install a Ti-bolt identified in paragraph
(c) of this AD on the aft connection of the tail
rotor ball bearing control of any helicopter.
(h) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, Strategic Policy
Rotorcraft Section, FAA, has the authority to
approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19.
In accordance with 14 CFR 39.19, send your
request to your principal inspector or local
Flight Standards District Office, as
appropriate. If sending information directly
to the manager of the certification office,
send it to the attention of the person
identified in paragraph (i)(1) of this AD.
Information may be emailed to: 9-ASW-FTW-
AMOC-Requests@faa.gov.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
(i) Related Information
(1) For more information about this AD,
contact Matt Fuller, AD Program Manager,
General Aviation & Rotorcraft Unit,
Airworthiness Products Section, Operational
Safety Branch, FAA, 10101 Hillwood Pkwy.,
Fort Worth, TX 76177; telephone (817) 222–
5110; email matthew.fuller@faa.gov.
(2) For service information identified in
this AD, contact Airbus Helicopters, 2701 N.
Forum Drive, Grand Prairie, TX 75052;
telephone (972) 641–0000 or (800) 232–0323;
fax (972) 641–3775; or at https://
www.airbus.com/helicopters/services/
technical-support.html. You may view the
referenced service information at the FAA,
Office of the Regional Counsel, Southwest
Region, 10101 Hillwood Pkwy., Room 6N–
321, Fort Worth, TX 76177. For information
on the availability of this material at the
FAA, call (817) 222–5110.
(3) The subject of this AD is addressed in
European Union Aviation Safety Agency
(EASA) AD No. 2019–0258, dated October
18, 2019. You may view the EASA AD on the
internet at https://www.regulations.gov in the
AD Docket.
Issued on February 22, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives
Compliance & Airworthiness Directive,
Aircraft Certification Service.
[FR Doc. 2021–03955 Filed 3–2–21; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–476]
Schedules of Controlled Substances:
Placement of 10 Specific Fentanyl-
Related Substances in Schedule I
AGENCY
: Drug Enforcement
Administration, Department of Justice.
ACTION
: Notice of proposed rulemaking.
SUMMARY
: The Drug Enforcement
Administration proposes placing N-(1-
(2-fluorophenethyl)piperidin-4-yl)-N-(2-
fluorophenyl)propionamide (2′-fluoro
ortho-fluorofentanyl), N-(1-(4-
methylphenethyl)piperidin-4-yl)-N-
phenylacetamide (4′-methyl acetyl
fentanyl), N-(1-phenethylpiperidin-4-
yl)-N,3-diphenylpropanamide (b′-
phenyl fentanyl; 3-phenylpropanoyl
fentanyl), N-phenyl-N-(1-(2-
phenylpropyl)piperidin-4-
yl)propionamide (b-methyl fentanyl), N-
(2-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)butyramide
(ortho-fluorobutyryl fentanyl; 2-
fluorobutyryl fentanyl), N-(2-
methylphenyl)-N-(1-
phenethylpiperidin-4-yl)acetamide
(ortho-methyl acetylfentanyl; 2-methyl
acetylfentanyl), 2-methoxy-N-(2-
methylphenyl)-N-(1-
phenethylpiperidin-4-yl)acetamide
(ortho-methyl methoxyacetylfentanyl),
N-(4-methylphenyl)-N-(1-
phenethylpiperidin-4-yl)propionamide
(para-methylfentanyl; 4-
methylfentanyl), N-(1-
phenethylpiperidin-4-yl)-N-
phenylbenzamide (phenyl fentanyl;
benzoyl fentanyl), N-(1-
phenethylpiperidin-4-yl)-N-
phenylthiophene-2-carboxamide
(thiofuranyl fentanyl), including their
isomers, esters, ethers, salts, and salts of
isomers, esters, and ethers, in schedule
I of the Controlled Substances Act.
These ten specific substances fall within
the definition of fentanyl-related
substances set forth in the February 6,
2018, temporary scheduling order.
Through the Temporary Reauthorization
and Study of the Emergency Scheduling
of Fentanyl Analogues Act, which
became law on February 6, 2020,
Congress extended the temporary
control of fentanyl-related substances
until May 6, 2021. If finalized, this
action would make permanent the
existing regulatory controls and
administrative, civil, and criminal
sanctions applicable to schedule I
controlled substances on persons who
handle (manufacture, distribute, reverse
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distribute, import, export, engage in
research, conduct instructional
activities or chemical analysis, or
possess), or propose to handle 2′-fluoro
ortho-fluorofentanyl, 4′-methyl acetyl
fentanyl, b′-phenyl fentanyl, b-methyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl.
DATES
: Comments must be submitted
electronically or postmarked on or
before April 2, 2021.
Requests for hearing and waivers of
an opportunity for a hearing or to
participate in a hearing must be
received on or before April 2, 2021.
ADDRESSES
: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–476’’ on all electronic and
written correspondence, including any
attachments.
•Electronic comments: Interested
persons may file written comments on
this proposal in accordance with 21 CFR
1308.43(g). The Drug Enforcement
Administration (DEA) encourages that
all comments be submitted
electronically through the Federal
eRulemaking Portal which provides the
ability to type short comments directly
into the comment field on the web page
or to attach a file for lengthier
comments. Please go to http://
www.regulations.gov and follow the
online instructions at that site for
submitting comments. Upon completion
of your submission you will receive a
Comment Tracking Number for your
comment. Please be aware that
submitted comments are not
instantaneously available for public
view on Regulations.gov. If you have
received a Comment Tracking Number,
your comment has been successfully
submitted and there is no need to
resubmit the same comment.
Commenters should be aware that the
electronic Federal Docket Management
System will not accept comments after
11:59 p.m. Easter Time on the last day
of the comment period.
•Paper comments: Paper comments
that duplicate the electronic submission
are not necessary. Should you wish to
mail a paper comment in lieu of an
electronic comment, it should be sent
via regular or express mail to: Drug
Enforcement Administration, Attn: DEA
Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield,
Virginia 22152.
•Hearing requests: Interested persons
may file a request for hearing or waiver
of hearing pursuant to 21 CFR 1308.44
and in accordance with 21 CFR 1316.45
and/or 1316.47, as applicable. All
requests for hearing and waivers of
participation must be sent to: Drug
Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive,
Springfield, Virginia 22152. All requests
for hearing and waivers of participation
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT
:
Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control
Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (571) 362–3249
SUPPLEMENTARY INFORMATION
:
Posting of Public Comments
Please note that all comments
received in response to this docket are
considered part of the public record.
They will, unless reasonable cause is
given, be made available by the Drug
Enforcement Administration (DEA) for
public inspection online at http://
www.regulations.gov. Such information
includes personal identifying
information (such as your name,
address, etc.) voluntarily submitted by
the commenter. The Freedom of
Information Act applies to all comments
received. 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 made
publicly available, 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 made
publicly available 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 made
publicly available, 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.
Comments containing personal
identifying information and confidential
business information identified as
directed above will be made publicly
available in redacted form. If a comment
has so much confidential business
information or personal identifying
information that it cannot be effectively
redacted, all or part of that comment
may not be made publicly available.
Comments posted to http://
www.regulations.gov may include any
personal identifying information (such
as name, address, and phone number)
included in the text of your electronic
submission that is not identified as
directed above as confidential.
An electronic copy of this document
and supplemental information to this
proposed rule are available at http://
www.regulations.gov for easy reference.
Request for Hearing or Waiver of
Participation in a Hearing
Pursuant to 21 U.S.C. 811(a), this
action is a formal rulemaking ‘‘on the
record after opportunity for a hearing.’’
Such proceedings are conducted
pursuant to the provisions of the
Administrative Procedure Act, 5 U.S.C.
551–559. 21 CFR 1308.41–1308.45; 21
CFR part 1316, subpart D. Interested
persons may file requests for hearing or
notices of intent to participate in a
hearing in conformity with the
requirements of 21 CFR 1308.44(a) or
(b), and include a statement of interest
in the proceeding and the objections or
issues, if any, concerning which the
person desires to be heard. Any
interested person may file a waiver of an
opportunity for a hearing or to
participate in a hearing together with a
written statement regarding the
interested person’s position on the
matters of fact and law involved in any
hearing as set forth in 21 CFR
1308.44(c).
All requests for a hearing and waivers
of participation must be sent to DEA
using the address information provided
above.
Legal Authority
The Controlled Substances Act (CSA)
provides that proceedings for the
issuance, amendment, or repeal of the
scheduling of any drug or other
substance may be initiated by the
Attorney General (delegated to the
Administrator of DEA pursuant to 28
CFR 0.100) on his own motion. 21
U.S.C. 811(a). This proposed action is
supported by a recommendation from
the Assistant Secretary for Health of
U.S. Department of Health and Human
Services (HHS) (Assistant Secretary) and
an evaluation of all other relevant data
by DEA. If finalized, this action would
make permanent the existing temporary
regulatory controls and administrative,
civil, and criminal sanctions of schedule
I controlled substances on any person
who handles or proposes to handle 2′-
fluoro ortho-fluorofentanyl, 4′-methyl
acetyl fentanyl, b′-phenyl fentanyl, b-
methyl fentanyl, ortho-fluorobutyryl
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1
HHS’ scientific and medical evaluation for the
other five fentanyl-related substances (benzodioxole
fentanyl, fentanyl carbamate, ortho-fluoro
isobutyryl fentanyl, ortho-fluoroacryl fentanyl, and
para-fluoro furanyl fentanyl) is ongoing. DEA will
not further discuss these five substances in this
proposed rule.
2
In November 2019, the Director-General of the
World Health Organization recommended to the
Secretary-General that crotonyl fentanyl be placed
in Schedule I of the Single Convention. On May 7,
2020, the Secretary-General advised the Secretary of
State of the United States, by letter, that during its
63rd session in March 2020, the Commission on
Narcotic Drugs voted to place crotonyl fentanyl in
Schedule I of the Single Convention (CND Mar/63/
2).
3
Comprehensive Drug Abuse Prevention and
Control Act of 1970, H.R. Rep. No. 91–1444, 91st
Cong., Sess. 1 (1970); reprinted in 1970
U.S.C.C.A.N. 4566, 4603.
fentanyl, ortho-methyl acetylfentanyl,
ortho-methyl methoxyacetyl fentanyl,
para-methylfentanyl, phenyl fentanyl,
and thiofuranyl fentanyl.
Background
On February 6, 2018, pursuant to 21
U.S.C. 811(h)(1), the then-Acting
Administrator of DEA published an
order in the Federal Register (83 FR
5188) temporarily placing fentanyl-
related substances, as defined in that
order, in schedule I of the CSA upon
finding that these substances pose an
imminent hazard to the public safety.
The 10 substances named in this
proposed rule (2′-fluoro ortho-
fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl) meet the existing
definition of fentanyl-related
substances. On April 19, 2019, DEA
specifically identified four of these 10
substances (2′-fluoro ortho-
fluorofentanyl, b′-phenyl fentanyl,
ortho-methyl acetylfentanyl, and
thiofuranyl fentanyl) as meeting the
definition of fentanyl-related
substances. 84 FR 16397. Although DEA
did not issue a Federal Register
publication to identify the other six
substances, the February 6, 2018,
temporary scheduling order emphasized
that, even still, a substance is controlled
by virtue of the order if it falls within
the definition of fentanyl-related
substances. 83 FR 5188, 5189. As
discussed below in Factor 3, all 10
substances meet the definition as they
are not otherwise controlled in any
other schedule (i.e., not included under
another Administration Controlled
Substance Code Number) and are
structurally related to fentanyl by one or
more of the five modifications listed
under the definition.
That temporary order was effective
upon the date of publication. Pursuant
to 21 U.S.C. 811(h)(2), the temporary
control of fentanyl-related substances, a
class of substances as defined in the
order, as well as the 10 specific
substances already covered by that
order, was set to expire on February 6,
2020. However, as explained in DEA’s
April 10, 2020, correcting amendment
(85 FR 20155), Congress overrode and
extended that expiration date until May
6, 2021, by enacting on February 6, 2020
the Temporary Reauthorization and
Study of the Emergency Scheduling of
Fentanyl Analogues Act (Pub. L. 116–
114, sec. 2, 134 Stat. 103). By operation
of law, the temporary control of
fentanyl-related substances, which
includes these 10 covered substances,
will remain in effect until May 6, 2021,
unless DEA permanently places them in
schedule I prior to May 6, 2021. As
discussed in the above Legal Authority
section, proceedings under 21 U.S.C.
811(a) may be initiated by the
Administrator of DEA on his own
motion.
The Acting Administrator, on his own
motion, is initiating proceedings to
permanently schedule the following 10
fentanyl-related substances: 2′-fluoro
ortho-fluorofentanyl, 4′-methyl acetyl
fentanyl, b′-phenyl fentanyl, b-methyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl. DEA gathered the
available information regarding the
pharmacology, chemistry, trafficking,
actual abuse, pattern of abuse, and the
relative potential for abuse for these 10
fentanyl-related substances, as well as
for six other fentanyl-related substances
(benzodioxole fentanyl, crotonyl
fentanyl, fentanyl carbamate, ortho-
fluoro isobutyryl fentanyl, ortho-
fluoroacryl fentanyl, and para-fluoro
furanyl fentanyl). On April 3, and
October 2, 2019, the then-Acting
Administrator submitted this data to the
Assistant Secretary, and requested that
HHS provide DEA with a scientific and
medical evaluation and a scheduling
recommendation for the 16 fentanyl-
related substances named above, in
accordance with 21 U.S.C. 811(b) and
(c).
Upon evaluating the scientific and
medical evidence, on July 2, 2020, the
Assistant Secretary submitted to the
Acting Administrator, HHS’s scientific
and medical evaluation and scheduling
recommendation for 11 of the 16
fentanyl-related substances, including
the 10 named substances in this
proposed rule as well as crotonyl
fentanyl.
1
Upon receipt of the scientific
and medical evaluation and scheduling
recommendation from HHS, DEA
reviewed these documents and all other
relevant data, and conducted its own
eight-factor analysis of the abuse
potential of the 10 substances in
accordance with 21 U.S.C. 811(c). On
October 2, 2020, DEA issued a final
order (85 FR 62215) for crotonyl
fentanyl to remain as a schedule I
substance under the CSA in order to
meet the United States’ obligations
under the 1961 Single Convention on
Narcotic Drugs (Single Convention),
March 30, 1961, 18 U.S.T. 1407, 570
U.N.T.S. 151, as amended.
2
As such,
crotonyl fentanyl will not be discussed
further in this scheduling action.
Proposed Determination To
Permanently Schedule 2′-Fluoro ortho-
Fluorofentanyl, 4′-Methyl Acetyl
Fentanyl, b-Methyl Fentanyl, b′-Phenyl
Fentanyl, ortho-Fluorobutyryl fentanyl,
ortho-Methyl Acetylfentanyl, ortho-
Methyl Methoxyacetyl Fentanyl, para-
Methylfentanyl, Phenyl Fentanyl, and
Thiofuranyl Fentanyl
As discussed in the background
section, the Acting Administrator is
initiating proceedings to permanently
add 2′-fluoro ortho-fluorofentanyl, 4′-
methyl acetyl fentanyl, b-methyl
fentanyl, b′-phenyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl to schedule I. DEA
has reviewed the scientific and medical
evaluation and scheduling
recommendation from HHS, and all
other relevant data, and conducted its
own eight-factor analysis of the abuse
potential of these 10 substances.
Included below is a brief summary of
each factor as analyzed by HHS and
DEA, and as considered by DEA in its
proposed scheduling action. Please note
that both the DEA and HHS 8-Factor
analyses and the Assistant Secretary’s
July 2, 2020, letter are available in their
entirety under the tab ‘‘Supporting
Documents’’ of the public docket for
this action at http://
www.regulations.gov under Docket
Number ‘‘DEA–476.’’
1. The Drug’s Actual or Relative
Potential for Abuse: The term ‘‘abuse’’ is
not defined in the CSA. However, the
legislative history of the CSA suggests
that DEA consider the following criteria
when determining whether a particular
drug or substance has a potential for
abuse:
3
(a) There is evidence that individuals are
taking the drug or drugs containing such a
substance in amounts sufficient to create a
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While law enforcement data is not direct
evidence of abuse, it can lead to an inference that
a drug has been diverted and abused. See 76 FR
77330, 77332, Dec. 12, 2011.
5
NFLIS is a DEA program and a national forensic
laboratory reporting system that systematically
collects results from drug chemistry analyses
conducted by state and local forensic laboratories
in the United States. The NFLIS database also
contains Federal data from U.S. Customs and
Border Protection (CBP). NFLIS only includes drug
chemistry results from completed analyses.
hazard to their health or to the safety of other
individuals or to the community; or
(b) There is significant diversion of the
drug or drugs containing such a substance
from legitimate drug channels; or
(c) Individuals are taking the drug or drugs
containing such a substance on their own
initiative rather than on the basis of medical
advice from a practitioner licensed by law to
administer such drugs in the course of his
professional practice; or
(d) The drug or drugs containing such a
substance are new drugs so related in their
action to a drug or drugs already listed as
having a potential for abuse to make it likely
that the drug will have the same potentiality
for abuse as such drugs, thus making it
reasonable to assume that there may be
significant diversions 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.
The abuse potential of 2′-fluoro ortho-
fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl is associated with
their pharmacological similarity to other
schedule I and II mu-opioid receptor
agonist substances, which have a high
potential for abuse. Similar to morphine
and fentanyl, these 10 substances have
been shown to bind and act as mu-
opioid receptor agonists.
These 10 substances have no
approved medical use in the United
States and have been encountered on
the illicit drug market. The use of some
fentanyl-related substances has been
associated with adverse health
outcomes, including death. The
appearance of several substances
structurally related to fentanyl in the
illicit drug market has resulted in a
significant increase in drug overdose
deaths in the United States. According
to the Centers for Disease Control and
Prevention (CDC) overdose death data
for 2018, there continues to be an
increase in the number of deaths related
to synthetic opioids. Opioids were
involved in about 70 percent of all drug-
involved overdose deaths in 2018.
Further, CDC reports demonstrate that
the increase in synthetic opioid
overdose deaths are largely attributed to
an increase in the supply of illicitly
manufactured fentanyl and substances
structurally related to fentanyl. Because
2′-fluoro ortho-fluorofentanyl, 4′-methyl
acetyl fentanyl, b-methyl fentanyl, b′-
phenyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl,
ortho-methyl methoxyacetyl fentanyl,
para-methylfentanyl, phenyl fentanyl,
and thiofuranyl fentanyl are not Food
and Drug Administration (FDA)-
approved drug products, a practitioner
may not legally prescribe them, and
these substances cannot be dispensed to
an individual. Therefore, the use of 2′-
fluoro ortho-fluorofentanyl, 4′-methyl
acetyl fentanyl, b-methyl fentanyl, b′-
phenyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl,
ortho-methyl methoxyacetyl fentanyl,
para-methylfentanyl, phenyl fentanyl,
and thiofuranyl fentanyl is without
medical advice, and accordingly leads
to the conclusion that these 10
substances are abused for their
opioidergic properties.
There are no legitimate drug channels
for 2′-fluoro ortho-fluorofentanyl, 4′-
methyl acetyl fentanyl, b-methyl
fentanyl, b′-phenyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl as marketed FDA-
approved drug products, but these
substances are available for purchase
from legitimate chemical companies for
research purposes. However, despite the
limited legitimate research use of these
10 substances, reports from public
health and law enforcement data
indicate that all 10 substances are being
abused and taken in amounts sufficient
to create a hazard to an individual’s
health. Data from forensic databases can
be used as an indicator of illicit activity
with drugs and abuse
4
within the
United States. According to the National
Forensic Laboratory Information System
(NFLIS),
5
which collects and analyzes
drug exhibits submitted to Federal,
State, and local forensic laboratories,
there were 235 total reports of seven of
the 10 substances (4′-methyl acetyl
fentanyl, b-methyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, para-methylfentanyl,
phenyl fentanyl, and thiofuranyl
fentanyl) between 2017 and 2020
(queried on July 16, 2020). In 2017 and
2018, U.S. Customs and Border
Protection (CBP) reported that two other
of the 10 substances (2′-fluoro ortho-
fluorofentanyl and b′-phenyl fentanyl)
have been positively identified in seized
drugs, respectively. In 2018, ortho-
methyl methoxyacetyl fentanyl was
positively identified in an exhibit
submitted to NMS laboratories for
analysis by the Department of
Homeland Security. Consequently, the
positive identification of the 10
substances in law enforcement
encounters indicates that these
substances are being abused, and thus
pose safety hazards to the health of
users.
2. Scientific Evidence of the Drug’s
Pharmacological Effects, if Known: 2′-
fluoro ortho-fluorofentanyl, 4′-methyl
acetyl fentanyl, b-methyl fentanyl, b′-
phenyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl,
ortho-methyl methoxyacetyl fentanyl,
para-methylfentanyl, phenyl fentanyl,
and thiofuranyl fentanyl are
pharmacologically similar to other
schedule I and schedule II mu-opioid
receptor agonist substances. The abuse
potential (assessed by drug
discriminative studies) of 2′-fluoro
ortho-fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl show that these
substances share discriminative
stimulus effects similar to fentanyl and
morphine. Similar to schedule I and II
opioid analgesics, these 10 substances
bind to and activate the mu-opioid
receptor. Additionally, behavioral
studies in animals demonstrate these 10
substances produce analgesic effects
similar to fentanyl and morphine. Pre-
treatment with naltrexone, an opioid
antagonist, attenuated analgesic effect of
these 10 substances, as well as fentanyl
and morphine. These data indicate that
the 10 substances are mu-opioid
receptor agonists with effects on the
central nervous system. Data from drug
discrimination studies showed that
these 10 substances share discriminative
stimulus effects similar to those of
morphine. Thus, it is concluded from in
vitro and in vivo pharmacological
studies that the effects of the 10
substances are similar to that of fentanyl
and morphine and are mediated by mu-
opioid receptor agonism.
3. The State of Current Scientific
Knowledge Regarding the Drug or Other
Substance: 2′-Fluoro ortho-
fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl are synthetic
opioids of the 4-anilidopiperidine
structural class, which includes
fentanyl. As defined in the February 6,
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2018, temporary order, fentanyl-related
substances include any substance not
otherwise controlled in any schedule
(i.e., not included under any other
Administration Controlled Substance
Code Number) that is structurally
related to fentanyl by one or more of the
following modifications:
(A) Replacement of the phenyl
portion of the phenethyl group by any
monocycle, whether or not further
substituted in or on the monocycle;
(B) substitution in or on the phenethyl
group with alkyl, alkenyl, alkoxyl,
hydroxyl, halo, haloalkyl, amino or
nitro groups;
(C) substitution in or on the
piperidine ring with alkyl, alkenyl,
alkoxyl, ester, ether, hydroxyl, halo,
haloalkyl, amino or nitro groups;
(D) replacement of the aniline ring
with any aromatic monocycle whether
or not further substituted in or on the
aromatic monocycle; and/or
(E) replacement of the N-propionyl
group by another acyl group.
According to the February 6, 2018,
temporary scheduling order, the
existence of a substance with any one,
or any combination, of above-mentioned
modifications (see Figure 1) would meet
the structural requirements of the
definition of fentanyl-related
substances. The present 10 substances
fall within the definition of fentanyl-
related substances by the following
modifications:
1. 2′-Fluoro ortho-fluorofentanyl:
Substitution on the phenethyl group
with a halo group and substitution on
the aniline ring (meets definition for
modifications B and D);
2. 4′-methyl acetyl fentanyl:
Substitution on the phenethyl group
with an alkyl group and replacement of
the N-propionyl group by another acyl
group (meets definition for
modifications B and E);
3. b-methyl fentanyl: Substitution on
the phenethyl group with an alkyl group
(meets definition for modification B);
4. b′-phenyl fentanyl: Replacement of
the N-propionyl group by another acyl
group (meets definition for modification
E);
5. ortho-fluorobutyryl fentanyl:
Substitution on the aniline ring and
replacement of the N-propionyl group
with another acyl group (meets
definition for modifications D and E);
6. ortho-methyl acetylfentanyl:
Substitution on the aniline ring and
replacement of the N-propionyl group
with another acyl group (meets
definition for modifications D and E);
7. ortho-methyl
methoxyacetylfentanyl: Substitution on
the aniline ring and replacement of the
N-propionyl group with another acyl
group (meets definition for
modifications D and E);
8. para-methylfentanyl: Substitution
on the aniline ring (meets definition for
modification D);
9. phenyl fentanyl: Replacement of
the N-propionyl group by another acyl
group (meets definition for modification
E); and
10. thiofuranyl fentanyl: Replacement
of the N-propionyl group by another
acyl group (meets definition for
modification E).
No study has been undertaken to
evaluate the efficacy, toxicology, and
safety of the 10 substances in humans.
It can be inferred from data obtained
from animal studies that these 10
substances have sufficient distribution
to the brain to produce depressant
effects similar to that of other mu-opioid
receptor agonists such as fentanyl. Data
from in vitro receptor binding studies
show that these 10 substances, similar
to fentanyl, display high selectivity for
the mu-opioid receptor over other
opioid receptor subtypes.
There are no FDA-approved
marketing applications for a drug
product containing 2′-fluoro ortho-
fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl for any therapeutic
indication in the United States.
Moreover, there are no clinical studies
or petitions which have claimed an
accepted medical use in the United
States for these 10 substances.
4. Its History and Current Pattern of
Abuse: 2′-Fluoro ortho-fluorofentanyl,
4′-methyl acetyl fentanyl, b-methyl
fentanyl, b′-phenyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl, like other
substances structurally related to
fentanyl, are disguised as a ‘‘legal’’
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6
If evidence of prescription or illicit use was not
available, fentanyl was categorized as illicitly-
manufactured fentanyl (‘‘IMF’’) because the vast
majority of fentanyl overdose deaths involve IMF.
Gladden RM, O’Donnell J, Mattson CL, Seth P.
Changes in Opioid-Involved Overdose Deaths by
Opioid Type and Presence of Benzodiazepines,
Cocaine, and Methamphetamine—25 States, July–
December 2017 to January–June 2018. MMWR Morb
Mortal Wkly Rep. 30; 68(34):737–744.
alternative to fentanyl. Between 2017
and 2020, law enforcement officials in
the United States encountered these 10
substances.
5. The Scope, Duration, and
Significance of Abuse: 2′-Fluoro ortho-
fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl, similar to other
substances structurally related to
fentanyl, are often used as recreational
drugs. The recreational use of these 10
substances and other fentanyl-related
substances continues to be of significant
concern as the United States currently is
in the midst of an opioid epidemic.
These substances are distributed to
users, often with unpredictable
outcomes. Because users of these
fentanyl-related substances and their
associated drug products are likely to
obtain these substances through
unregulated sources, the identity,
purity, and quantity are uncertain and
inconsistent, thus posing significant
adverse health risks to abusers.
Evidence that these 10 substances are
being abused and trafficked is
confirmed by law enforcement
encounters. NFLIS contained 235
reports of 4′-methyl acetyl fentanyl, b-
methyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl,
para-methylfentanyl, phenyl fentanyl,
and thiofuranyl fentanyl from Federal,
State, and local forensic laboratories
between 2017 and 2020. In 2017 and
2018, CBP reported that 2′-fluoro ortho-
fluorofentanyl and b′-phenyl fentanyl
have been positively identified in seized
drugs, respectively. In 2018, ortho-
methyl methoxyacetyl fentanyl was
positively identified in an exhibit
submitted to NMS laboratories for
analysis by the Department of
Homeland Security.
6. What, if Any, Risk There Is to the
Public Health: The increase in opioid
overdose deaths in the United States has
been exacerbated by the availability of
potent synthetic opioids such as
fentanyl and structurally related
substances in the illicit drug market.
These substances have a history of being
trafficked as replacements for heroin
and other synthetic opioids.
Increasingly, law enforcement has
encountered fentanyl and substances
structurally related to fentanyl in
counterfeit prescription opioids, heroin,
and other street drugs such as cocaine,
methamphetamine, and synthetic
cannabinoids. Fentanyl is a potent
synthetic opioid that is primarily
prescribed for acute and chronic pain
and is approximately 100 times more
potent than morphine. As such, fentanyl
has a high risk of abuse, dependence
and overdose that can lead to death.
Because fentanyl-related substances, as
defined in the February 6, 2018,
temporary order, have similar chemical
structure to fentanyl, these substances
are expected to have similar biological
effects. In in vitro and in vivo studies,
2′-fluoro ortho-fluorofentanyl, 4′-methyl
acetyl fentanyl, b-methyl fentanyl, b′-
phenyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl,
ortho-methyl methoxyacetyl fentanyl,
para-methylfentanyl, phenyl fentanyl,
and thiofuranyl fentanyl produced
pharmacological effects similar to
fentanyl. Thus, these 10 substances pose
the same qualitative public health risks
as heroin, fentanyl, and other mu-opioid
receptor agonists.
According to a CDC report, from 2013
to 2017, opioid-related overdose deaths
in the United States increased 90
percent from 25,052 to 47,600. The
increase in the number of opioid-related
deaths was primarily driven by illicitly
manufactured fentanyl.
6
According to
CDC 2018 provisional data, there were
68,500 drug overdose fatalities; of those,
47,600 (∼69 percent) involved an opioid.
The use of some fentanyl-related
substances has been associated with
adverse health outcomes, including
death.
7. Its Psychic or Physiological
Dependence Liability: There are no pre-
clinical and clinical studies that have
evaluated the dependence potential of
2′-fluoro ortho-fluorofentanyl, 4′-methyl
acetyl fentanyl, b-methyl fentanyl, b′-
phenyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl,
ortho-methyl methoxyacetyl fentanyl,
para-methylfentanyl, phenyl fentanyl,
and thiofuranyl fentanyl. These 10
substances are mu-opioid receptor
agonists, and discontinuation of the use
of mu-opioid receptor agonists such as
fentanyl and morphine is known to
cause withdrawal indicative of physical
dependence. Opioid withdrawal
includes nausea and vomiting,
depression, agitation, anxiety, craving,
sweats, hypertension, diarrhea, and
fever.
8. Whether the Substance Is an
Immediate Precursor of a Substance
Already Controlled Under the CSA: 2′-
Fluoro ortho-fluorofentanyl, 4′-methyl
acetyl fentanyl, b-methyl fentanyl, b′-
phenyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl,
ortho-methyl methoxyacetyl fentanyl,
para-methylfentanyl, phenyl fentanyl,
and thiofuranyl fentanyl are not
considered immediate precursors of any
controlled substance of the CSA as
defined by 21 U.S.C. 802(23).
Conclusion: After considering the
scientific and medical evaluation
conducted by HHS, HHS’s scheduling
recommendation, and DEA’s own eight-
factor analysis, DEA finds that the facts
and all relevant data constitute
substantial evidence of the potential for
abuse of 2′-fluoro ortho-fluorofentanyl,
4′-methyl acetyl fentanyl, b-methyl
fentanyl, b′-phenyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl. As such, DEA
hereby proposes to permanently
schedule 2′-fluoro ortho-fluorofentanyl,
4′-methyl acetyl fentanyl, b-methyl
fentanyl, b′-phenyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl in schedule I of 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 CSA
also 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
recommendation of the Assistant
Secretary for Health of HHS and review
of all other available data, the Acting
Administrator of DEA, pursuant to 21
U.S.C. 811(a) and 21 U.S.C. 812(b)(1),
finds that:
(1) 2′-Fluoro ortho-fluorofentanyl, 4′-
methyl acetyl fentanyl, b-methyl
fentanyl, b′-phenyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl have a high
potential for abuse.
According to HHS, 2′-fluoro ortho-
fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl, similar to fentanyl,
are mu-opioid receptor agonists. These
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Although there is no evidence suggesting that 2′-
fluoro ortho-fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl fentanyl,
ortho-fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl methoxyacetyl
fentanyl, para-methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl have a currently accepted
medical use in treatment in the United States, it
bears noting that a drug cannot be found to have
such medical use unless DEA concludes that it
satisfies a five-part test. Specifically, with respect
to a drug that has not been approved by the FDA,
to have a currently accepted medical use in
treatment in the United States, all of the following
must be demonstrated:
i. The drug’s chemistry must be known and
reproducible;
ii. there must be adequate safety studies;
iii. there must be adequate and well-controlled
studies proving efficacy;
iv. the drug must be accepted by qualified
experts; and
v. the scientific evidence must be widely
available.
57 FR 10499 (1992), pet. for rev. denied, Alliance
for Cannabis Therapeutics v. DEA, 15 F.3d 1131,
1135 (D.C. Cir. 1994).
8
2′-fluoro ortho-fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl fentanyl,
ortho-fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl methoxyacetyl
fentanyl, para-methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl, are covered by the February 6,
2018, temporary scheduling order, and are currently
subject to schedule I controls on a temporary basis,
pursuant to 21 U.S.C. 811(h). 83 FR 5188.
substances have analgesic effects, and
these effects are mediated by mu-opioid
receptor agonism. HHS states that
substances that produce mu-opioid
receptor agonist effects in the central
nervous system (e.g., morphine and
fentanyl) are considered as having a
high potential for abuse. Data obtained
from drug discrimination studies
indicate that 2′-fluoro ortho-
fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl fully substituted for
the discriminative stimulus effects of
morphine.
(2) 2′-Fluoro ortho-fluorofentanyl, 4′-
methyl acetyl fentanyl, b-methyl
fentanyl, b′-phenyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl have no currently
accepted medical use in treatment in
the United States.
According to HHS, there are no FDA-
approved new drug applications for 2′-
fluoro ortho-fluorofentanyl, 4′-methyl
acetyl fentanyl, b-methyl fentanyl, b′-
phenyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl,
ortho-methyl methoxyacetyl fentanyl,
para-methylfentanyl, phenyl fentanyl,
and thiofuranyl fentanyl in the United
States. There are no known
therapeutical applications for these
fentanyl-related substances and thus
they have no currently accepted medical
use in the United States.
7
(3) There is a lack of accepted safety
for use of 2′-fluoro ortho-fluorofentanyl,
4′-methyl acetyl fentanyl, b-methyl
fentanyl, b′-phenyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl under medical
supervision.
Because 2′-fluoro ortho-
fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl have no FDA-
approved medical use and have not
been thoroughly investigated as new
drugs, their safety for use under medical
supervision is undetermined. Thus,
there is a lack of accepted safety for use
of 2′-fluoro ortho-fluorofentanyl, 4′-
methyl acetyl fentanyl, b-methyl
fentanyl, b′-phenyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl under medical
supervision.
Based on these findings, the Acting
Administrator of DEA concludes that 2′-
fluoro ortho-fluorofentanyl, 4′-methyl
acetyl fentanyl, b-methyl fentanyl, b′-
phenyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl,
ortho-methyl methoxyacetyl fentanyl,
para-methylfentanyl, phenyl fentanyl,
and thiofuranyl fentanyl, including their
isomers, esters, ethers, salts, and salts of
isomers, esters, and ethers warrant
continued control in schedule I of the
CSA. 21 U.S.C. 812(b)(1).
Requirements for handling 2′-fluoro
ortho-fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl.
If this rule is finalized as proposed, 2′-
fluoro ortho-fluorofentanyl, 4′-methyl
acetyl fentanyl, b-methyl fentanyl, b′-
phenyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl,
ortho-methyl methoxyacetyl fentanyl,
para-methylfentanyl, phenyl fentanyl,
and thiofuranyl fentanyl would
continue
8
to be subject to the CSA’s
schedule I regulatory controls and
administrative, civil, and criminal
sanctions applicable to the manufacture,
distribution, reverse distribution,
dispensing, importation, exportation,
research, and conduct of instructional
activities, including the following:
1. Registration. Any person who
handles (manufactures, distributes,
reverse distributes, dispenses, imports,
exports, engages in research, or
conducts instructional activities or
chemical analysis with, or possesses) 2′-
fluoro ortho-fluorofentanyl, 4′-methyl
acetyl fentanyl, b-methyl fentanyl, b′-
phenyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl,
ortho-methyl methoxyacetyl fentanyl,
para-methylfentanyl, phenyl fentanyl,
and thiofuranyl fentanyl, or who desires
to handle 2′-fluoro ortho-fluorofentanyl,
4′-methyl acetyl fentanyl, b-methyl
fentanyl, b′-phenyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl is required to be
registered with DEA to conduct such
activities pursuant to 21 U.S.C. 822,
823, 957, and 958, and in accordance
with 21 CFR parts 1301 and 1312.
2. Security. 2′-Fluoro ortho-
fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl are subject to
schedule I security requirements and
must be handled and stored pursuant to
21 U.S.C. 821, 823, and in accordance
with 21 CFR 1301.71–1301.93. Non-
practitioners handling 2′-fluoro ortho-
fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl also must comply
with the employee screening
requirements of 21 CFR 1301.90–
1301.93.
3. Labeling and Packaging. All labels
and labeling for commercial containers
of 2′-fluoro ortho-fluorofentanyl, 4′-
methyl acetyl fentanyl, b-methyl
fentanyl, b′-phenyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl must be in
compliance with 21 U.S.C. 825 and
958(e), and be in accordance with 21
CFR part 1302.
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4. Quota. Only registered
manufacturers are permitted to
manufacture 2′-fluoro ortho-
fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl in accordance with
a quota assigned pursuant to 21 U.S.C.
826 and in accordance with 21 CFR part
1303.
5. Inventory. Any person registered
with DEA to handle 2′-fluoro ortho-
fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl must have an initial
inventory of all stocks of controlled
substances (including these substances)
on hand on the date the registrant first
engages in the handling of controlled
substances pursuant to 21 U.S.C. 827
and 958, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11.
After the initial inventory, every DEA
registrant must take a new inventory of
all stocks of controlled substances
(including 2′-fluoro ortho-
fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl) on hand every two
years pursuant to 21 U.S.C. 827 and 958,
and in accordance with 21 CFR 1304.03,
1304.04, and 1304.11.
6. Records and Reports. Every DEA
registrant is required to maintain
records and submit reports with respect
to 2′-fluoro ortho-fluorofentanyl, 4′-
methyl acetyl fentanyl, b-methyl
fentanyl, b′-phenyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl, pursuant to 21
U.S.C. 827 and 958(e), and in
accordance with 21 CFR parts 1304 and
1312.
7. Order Forms. Every DEA registrant
who distributes 2′-fluoro ortho-
fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl is required to
comply with the order form
requirements, pursuant to 21 U.S.C. 828
and 21 CFR part 1305.
8. Importation and Exportation. All
importation and exportation of 2′-fluoro
ortho-fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl must be in
compliance with 21 U.S.C. 952, 953,
957, and 958, and in accordance with 21
CFR part 1312.
9. Liability. Any activity involving 2′-
fluoro ortho-fluorofentanyl, 4′-methyl
acetyl fentanyl, b-methyl fentanyl, b′-
phenyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl,
ortho-methyl methoxyacetyl fentanyl,
para-methylfentanyl, phenyl fentanyl,
and thiofuranyl fentanyl not authorized
by, or in violation of, the CSA or its
implementing regulations is unlawful,
and could subject the person to
administrative, civil, and/or criminal
sanctions.
Regulatory Analyses
Executive Orders 12866 (Regulatory
Planning and Review) and 13563
(Improving Regulation and Regulatory
Review)
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 (OMB)
pursuant to section 3(d)(1) of Executive
Order (E.O.) 12866 and the principles
reaffirmed in E.O. 13563.
Executive Order 12988, Civil Justice
Reform
This proposed regulation meets the
applicable standards set forth in
sections 3(a) and 3(b)(2) of E.O. 12988
to eliminate drafting errors and
ambiguity, minimize litigation, provide
a clear legal standard for affected
conduct, and promote simplification
and burden reduction.
Executive Order 13132, Federalism
This proposed rulemaking does not
have federalism implications warranting
the application of E.O. 13132. The
proposed rule does not have substantial
direct effects on the States, on the
relationship between the National
Government and the States, or the
distribution of power and
responsibilities among the various
levels of government.
Executive Order 13175, Consultation
and Coordination With Indian Tribal
Governments
This proposed rule does not have
tribal implications warranting the
application of E.O. 13175. It does not
have substantial direct effects on one or
more Indian tribes, on the relationship
between the Federal Government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal Government and Indian tribes.
Regulatory Flexibility Act
The Acting Administrator, in
accordance with the Regulatory
Flexibility Act, 5 U.S.C. 601–602, has
reviewed this proposed rule and by
approving it, certifies that it will not
have a significant economic impact on
a substantial number of small entities.
On February 6, 2018, DEA published an
order to temporarily place fentanyl-
related substances, as defined in the
order, in schedule I of the CSA pursuant
to the temporary scheduling provisions
of 21 U.S.C. 811(h). DEA estimates that
all entities handling or planning to
handle 2′-fluoro ortho-fluorofentanyl, 4′-
methyl acetyl fentanyl, b-methyl
fentanyl, b′-phenyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl have already
established and implemented the
systems and processes required to
handle these substances which meet the
definition of fentanyl-related
substances.
There are currently 57 registrations
authorized to handle the fentanyl-
related substances as a class, which
include 2′-fluoro ortho-fluorofentanyl,
4′-methyl acetyl fentanyl, b-methyl
fentanyl, b′-phenyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl, as well as a
number of registered analytical labs that
are authorized to handle schedule I
controlled substances generally. These
57 registrations represent 51 entities, of
which eight are small entities.
Therefore, DEA estimates eight small
entities are affected by this proposed
rule.
A review of the 57 registrations
indicates that all entities that currently
handle fentanyl-related substances,
including 2′-fluoro ortho-fluorofentanyl,
4′-methyl acetyl fentanyl, b-methyl
fentanyl, b′-phenyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl
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methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl, also handle other
schedule I controlled substances, and
have established and implemented (or
maintain) the systems and processes
required to handle 2′-fluoro ortho-
fluorofentanyl, 4′-methyl acetyl
fentanyl, b-methyl fentanyl, b′-phenyl
fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-
methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl. Therefore, DEA
anticipates that this proposed rule will
impose minimal or no economic impact
on any affected entities; and thus, will
not have a significant economic impact
on any of the eight affected small
entities. Therefore, DEA has concluded
that this proposed rule will not have a
significant effect on a substantial
number of small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded
Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has
determined and certifies that this action
would not result in any Federal
mandate that may result ‘‘in the
expenditure by State, local, and tribal
governments, in the aggregate, or by the
private sector, of $100 million or more
(adjusted annually for inflation) in any
1 year . . . .’’ Therefore, neither a Small
Government Agency Plan nor any other
action is required under UMRA of 1995.
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. This action would
not impose recordkeeping or reporting
requirements on State or local
governments, individuals, businesses, or
organizations. An agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
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, DEA
proposes to amend 21 CFR part 1308 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),
956(b), unless otherwise noted.
■2. In § 1308.11:
■a. Redesignate paragraph (75) as
paragraph (b)(84);
■b. Add paragraph (b)(83);
■c. Redesignate paragraphs (b)(65)
through (71) as paragraphs (b)(76)
through (82);
■d. Add a new paragraph (b)(75);
■e. Redesignate paragraphs (b)(60)
through (64) as paragraphs (b)(70)
through (74);
■f. Add a new paragraph (69);
■g. Redesignate paragraphs (b)(56)
through (59) as paragraphs (b)(65)
through (68);
■h. Add a new paragraph (64);
■i. Redesignate paragraph (b)(55) as
paragraph (b)(63);
■j. Add new paragraphs (b)(61) and
(62);
■k. Redesignate paragraphs (b)(45)
through (54) as paragraphs (b)(51)
through (60);
■l. Add new paragraph (b)(50);
■m. Redesignate paragraphs (b)(37)
through (44) as paragraphs (b)(42)
through (49);
■n. Add a new paragraph (b)(41);
■o. Redesignate paragraph (b)(36) as
paragraph (b)(40);
■p. Add a reserved paragraph (b)(39);
■q. Redesignate paragraphs (b)(22)
through (35) as paragraphs (b)(25)
through (38);
■r. Add a reserved paragraph (b)(24);
■s. Redesignate paragraphs (b)(17)
through (21) as paragraphs (b)(19)
through (23); and
■t. Add new paragraphs (b)(17) and
(18).
The additions to read as follows:
§ 1308.11 Schedule I.
* * * * *
(b) * * *
(17) Beta-methyl fentanyl (N-phenyl-N-(1-(2-phenylpropyl)piperidin-4-yl)propionamide; other name: b-methyl fentanyl) ............... 9856
(18) Beta′-phenyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N,3-diphenylpropanamide; other names: b′-phenyl fentanyl; 3-
phenylpropanoyl fentanyl) ....................................................................................................................................................................... 9842
*******
(41) 2′-Fluoro ortho-fluorofentanyl (N-(1-(2-fluorophenethyl)piperidin-4-yl)-N-(2-fluorophenyl)propionamide; other name: 2′-
fluoro 2-fluorofentanyl) ............................................................................................................................................................................ 9829
*******
(50) 4′-Methyl acetyl fentanyl (N-(1-(4-methylphenethyl)piperidin-4-yl)-N-phenylacetamide) .............................................................. 9819
*******
(61) ortho-Fluorobutyryl fentanyl (N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide; other name: 2-fluorobutyryl
fentanyl) ..................................................................................................................................................................................................... 9846
(62) ortho-Methyl acetylfentanyl (N-(2-methylphenyl)-N-(1-phenethylpiperidin-4-yl)acetamide; other name: 2-methyl
acetylfentanyl) ........................................................................................................................................................................................... 9848
*******
(64) ortho-Methyl methoxyacetyl fentanyl (2-methoxy-N-(2-methylphenyl)-N-(1-phenethylpiperidin-4-yl)acetamide; other name:
2-methyl methoxyacetyl fentanyl) ........................................................................................................................................................... 9820
*******
(69) para-Methylfentanyl (N-(4-methylphenyl)-N-(1-phenethylpiperidin-4-yl)propionamide; other name: 4-methylfentanyl) ........... 9817
*******
(75) Phenyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylbenzamide; other name: benzoyl fentanyl ........................................... 9841
*******
(83) Thiofuranyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylthiophene-2-carboxamide; other names: 2-thiofuranyl fentanyl;
thiophene fentanyl) ................................................................................................................................................................................... 9839
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1
See 63 FR 57356 (October 27, 1998).
2
As originally promulgated, the NO
X
SIP Call
also addressed good neighbor obligations under the
1997 8-hour ozone NAAQS, but EPA subsequently
stayed and later rescinded the rule’s provisions
with respect to that standard. See 65 FR 56245
(September 18, 2000); 84 FR 8422 (March 8, 2019).
3
CAIR had separate trading programs for annual
sulfur dioxide emissions, seasonal NO
X
emissions,
and annual NO
X
emissions.
* * * * *
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021–04214 Filed 3–2–21; 8:45 am]
BILLING CODE 4410–09–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R04–OAR–2020–0129; FRL–10020–
85–Region 4]
Air Plan Approval; AL; NO
X
SIP Call
and Removal of CAIR
AGENCY
: Environmental Protection
Agency (EPA).
ACTION
: Proposed rule.
SUMMARY
: The Environmental Protection
Agency (EPA) is proposing to approve a
State Implementation Plan (SIP)
revision submitted by the State of
Alabama through a letter dated February
27, 2020, to add regulations maintaining
compliance with the State’s Nitrogen
Oxide (NO
X
) SIP Call obligations for
large non-electricity generating units
(non-EGUs), to repeal the State’s
previously sunsetted NO
X
Budget
Trading Program regulations, and to
repeal the State’s Clean Air Interstate
Rule (CAIR) regulations. EPA is also
proposing to conditionally approve into
the SIP state regulations that establish
monitoring and reporting requirements
for units subject to the NO
X
SIP Call,
including alternative monitoring
options for certain sources for NO
X
SIP
Call purposes. In addition, EPA is
proposing to make ministerial changes
to reflect the State’s renumbering of an
existing regulation for ‘‘New
Combustion Sources.’’
DATES
: Comments must be received on
or before April 2, 2021.
ADDRESSES
: Submit your comments,
identified by Docket ID No. EPA–R04–
OAR–2020–0129 at
www.regulations.gov. Follow the online
instructions for submitting comments.
Once submitted, comments cannot be
edited or removed from Regulations.gov.
EPA may publish any comment received
to its public docket. Do not submit
electronically any information you
consider to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Multimedia submissions (audio, video,
etc.) must be accompanied by a written
comment. The written comment is
considered the official comment and
should include discussion of all points
you wish to make. EPA will generally
not consider comments or comment
contents located outside of the primary
submission (i.e., on the web, cloud, or
other file sharing system). For
additional submission methods, the full
EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
www2.epa.gov/dockets/commenting-
epa-dockets.
FOR FURTHER INFORMATION CONTACT
:
Steven Scofield, Air Regulatory
Management Section, Air Planning and
Implementation Branch, Air and
Radiation Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth
Street SW, Atlanta, Georgia 30303–8960.
The telephone number is (404) 562–
9034. Mr. Scofield can also be reached
via electronic mail at scofield.steve@
epa.gov.
SUPPLEMENTARY INFORMATION
:
I. Background
Under Clean Air Act (CAA or Act)
section 110(a)(2)(D)(i)(I), also called the
good neighbor provision, states are
required to address the interstate
transport of air pollution. Specifically,
the good neighbor provision requires
that each state’s implementation plan
contain adequate provisions to prohibit
air pollutant emissions from within the
state that will significantly contribute to
nonattainment of the national ambient
air quality standards (NAAQS), or that
will interfere with maintenance of the
NAAQS, in any other state.
In October 1998 (63 FR 57356), EPA
finalized the ‘‘Finding of Significant
Contribution and Rulemaking for
Certain States in the Ozone Transport
Assessment Group Region for Purposes
of Reducing Regional Transport of
Ozone’’ (NO
X
SIP Call). The NO
X
SIP
Call required eastern states, including
Alabama, to submit SIPs that prohibit
excessive emissions of ozone season
NO
X
by implementing statewide
emissions budgets.
1
The NO
X
SIP Call
addressed the good neighbor provision
for the 1979 ozone NAAQS and was
designed to mitigate the impact of
transported NO
X
emissions, one of the
precursors of ozone.
2
EPA developed
the NO
X
Budget Trading Program, an
allowance trading program that states
could adopt to meet their obligations
under the NO
X
SIP Call. This trading
program allowed the following sources
to participate in a regional cap and trade
program: Generally EGUs with capacity
greater than 25 megawatts (MW); and
large industrial non-EGUs, such as
boilers and combustion turbines, with a
rated heat input greater than 250 million
British thermal units per hour (MMBtu/
hr). The NO
X
SIP Call also identified
potential reductions from cement kilns
and stationary internal combustion
engines.
To comply with the NO
X
SIP Call
requirements, in 2001, the Alabama
Department of Environmental
Management (ADEM) submitted a
revision to add new rule sections to the
SIP-approved version of Alabama
Administrative Code Chapter 335–3–1,
General Provisions, and Chapter 335–3–
8, Control of Nitrogen Oxides
Emissions. EPA approved the revision
as compliant with Phase I of the NO
X
SIP Call in 2001. See 66 FR 36919 (July
16, 2001). The approved revision
required EGUs and large non-EGUs in
the State to participate in the NO
X
Budget Trading Program beginning in
2004. In 2005, Alabama submitted, and
EPA approved, a SIP revision to address
additional emissions reductions
required for the NO
X
SIP Call under
Phase II. See 70 FR 76694 (Dec. 28,
2005).
In 2005, EPA published CAIR, which
required several eastern states,
including Alabama, to submit SIPs that
prohibited emissions consistent with
revised ozone season (and annual) NO
X
budgets. See 70 FR 25162 (May 12,
2005); see also 71 FR 25328 (April 28,
2006). CAIR addressed the good
neighbor provision for the 1997 ozone
NAAQS and 1997 fine particulate
matter (PM
2.5
) NAAQS and was
designed to mitigate the impact of
transported NO
X
emissions with respect
to ozone and PM
2.5.
CAIR established
several trading programs that EPA
implemented through federal
implementation plans (FIPs) for EGUs
greater than 25 MW in each affected
state, but not large non-EGUs; states
could submit SIPs to replace the FIPs
that achieved the required emission
reductions from EGUs and/or other
types of sources.
3
When the CAIR
trading program for ozone season NO
X
was implemented beginning in 2009,
EPA discontinued administration of the
NO
X
Budget Trading Program; however,
the requirements of the NO
X
SIP Call
continued to apply.
On October 1, 2007 (72 FR 55659),
EPA approved revisions to Alabama’s
SIP that incorporated requirements for
CAIR. Consistent with CAIR’s
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