12296 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-FTWAMOC-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 FentanylRelated 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)-Nphenylacetamide (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)-Nphenylbenzamide (phenyl fentanyl; 

benzoyl fentanyl), N-(1- 

phenethylpiperidin-4-yl)-Nphenylthiophene-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 


jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Proposed Rules 12297 

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, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, 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, bmethyl fentanyl, ortho-fluorobutyryl 


jbell on DSKJLSW7X2PROD with PROPOSALS
12298 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Proposed Rules 

1HHS’ 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). 

3Comprehensive 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 fentanylrelated 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 orthofluorofentanyl, 4′-methyl acetyl 

fentanyl, b-methyl fentanyl, b′-phenyl 

fentanyl, ortho-fluorobutyryl fentanyl, 

ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, 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 orthofluorofentanyl, 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, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, 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, orthofluoro isobutyryl fentanyl, orthofluoroacryl 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 fentanylrelated 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 orthoFluorofentanyl, 4′-Methyl Acetyl 

Fentanyl, b-Methyl Fentanyl, b′-Phenyl 

Fentanyl, ortho-Fluorobutyryl fentanyl, 

ortho-Methyl Acetylfentanyl, orthoMethyl Methoxyacetyl Fentanyl, paraMethylfentanyl, 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, orthofluorobutyryl fentanyl, ortho-methyl 

acetylfentanyl, ortho-methyl 

methoxyacetyl fentanyl, paramethylfentanyl, 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 


jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Proposed Rules 12299 

4While 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. 

5NFLIS 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 orthofluorofentanyl, 4′-methyl acetyl 

fentanyl, b-methyl fentanyl, b′-phenyl 

fentanyl, ortho-fluorobutyryl fentanyl, 

ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, 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 muopioid 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 druginvolved 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, orthofluorobutyryl fentanyl, ortho-methyl 

acetylfentanyl, ortho-methyl 

methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and 

thiofuranyl fentanyl as marketed FDAapproved 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, orthofluorobutyryl 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 orthofluorofentanyl and b′-phenyl fentanyl) 

have been positively identified in seized 

drugs, respectively. In 2018, orthomethyl 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, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, 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. Pretreatment 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 muopioid receptor agonism. 

3. The State of Current Scientific 

Knowledge Regarding the Drug or Other 

Substance: 2′-Fluoro orthofluorofentanyl, 4′-methyl acetyl 

fentanyl, b-methyl fentanyl, b′-phenyl 

fentanyl, ortho-fluorobutyryl fentanyl, 

ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and 

thiofuranyl fentanyl are synthetic 

opioids of the 4-anilidopiperidine 

structural class, which includes 

fentanyl. As defined in the February 6, 


jbell on DSKJLSW7X2PROD with PROPOSALS
12300 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Proposed Rules 

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 fentanylrelated 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 orthofluorofentanyl, 4′-methyl acetyl 

fentanyl, b-methyl fentanyl, b′-phenyl 

fentanyl, ortho-fluorobutyryl fentanyl, 

ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, 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, orthofluorobutyryl fentanyl, ortho-methyl 

acetylfentanyl, ortho-methyl 

methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and 

thiofuranyl fentanyl, like other 

substances structurally related to 

fentanyl, are disguised as a ‘‘legal’’ 


jbell on DSKJLSW7X2PROD with PROPOSALSEP03MR21.102</GPH>
Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Proposed Rules 12301 

6 If evidence of prescription or illicit use was not 

available, fentanyl was categorized as illicitlymanufactured 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 orthofluorofentanyl, 4′-methyl acetyl 

fentanyl, b-methyl fentanyl, b′-phenyl 

fentanyl, ortho-fluorobutyryl fentanyl, 

ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, 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, bmethyl 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 orthofluorofentanyl and b′-phenyl fentanyl 

have been positively identified in seized 

drugs, respectively. In 2018, orthomethyl 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 preclinical 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 eightfactor 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, orthofluorobutyryl fentanyl, ortho-methyl 

acetylfentanyl, ortho-methyl 

methoxyacetyl fentanyl, paramethylfentanyl, 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, orthofluorobutyryl fentanyl, ortho-methyl 

acetylfentanyl, ortho-methyl 

methoxyacetyl fentanyl, paramethylfentanyl, 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, orthofluorobutyryl fentanyl, ortho-methyl 

acetylfentanyl, ortho-methyl 

methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and 

thiofuranyl fentanyl have a high 

potential for abuse. 

According to HHS, 2′-fluoro orthofluorofentanyl, 4′-methyl acetyl 

fentanyl, b-methyl fentanyl, b′-phenyl 

fentanyl, ortho-fluorobutyryl fentanyl, 

ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and 

thiofuranyl fentanyl, similar to fentanyl, 

are mu-opioid receptor agonists. These 


jbell on DSKJLSW7X2PROD with PROPOSALS
12302 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Proposed Rules 

7Although 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 orthofluorofentanyl, 4′-methyl acetyl 

fentanyl, b-methyl fentanyl, b′-phenyl 

fentanyl, ortho-fluorobutyryl fentanyl, 

ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, 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, orthofluorobutyryl fentanyl, ortho-methyl 

acetylfentanyl, ortho-methyl 

methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and 

thiofuranyl fentanyl have no currently 

accepted medical use in treatment in 

the United States. 

According to HHS, there are no FDAapproved 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, orthofluorobutyryl fentanyl, ortho-methyl 

acetylfentanyl, ortho-methyl 

methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and 

thiofuranyl fentanyl under medical 

supervision. 

Because 2′-fluoro orthofluorofentanyl, 4′-methyl acetyl 

fentanyl, b-methyl fentanyl, b′-phenyl 

fentanyl, ortho-fluorobutyryl fentanyl, 

ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and 

thiofuranyl fentanyl have no FDAapproved 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, orthofluorobutyryl fentanyl, ortho-methyl 

acetylfentanyl, ortho-methyl 

methoxyacetyl fentanyl, paramethylfentanyl, 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, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, 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, orthofluorobutyryl fentanyl, ortho-methyl 

acetylfentanyl, ortho-methyl 

methoxyacetyl fentanyl, paramethylfentanyl, 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 orthofluorofentanyl, 4′-methyl acetyl 

fentanyl, b-methyl fentanyl, b′-phenyl 

fentanyl, ortho-fluorobutyryl fentanyl, 

ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, 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. Nonpractitioners handling 2′-fluoro orthofluorofentanyl, 4′-methyl acetyl 

fentanyl, b-methyl fentanyl, b′-phenyl 

fentanyl, ortho-fluorobutyryl fentanyl, 

ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, 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, orthofluorobutyryl fentanyl, ortho-methyl 

acetylfentanyl, ortho-methyl 

methoxyacetyl fentanyl, paramethylfentanyl, 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. 


jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Proposed Rules 12303 

4. Quota. Only registered 

manufacturers are permitted to 

manufacture 2′-fluoro orthofluorofentanyl, 4′-methyl acetyl 

fentanyl, b-methyl fentanyl, b′-phenyl 

fentanyl, ortho-fluorobutyryl fentanyl, 

ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, 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 orthofluorofentanyl, 4′-methyl acetyl 

fentanyl, b-methyl fentanyl, b′-phenyl 

fentanyl, ortho-fluorobutyryl fentanyl, 

ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, 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 orthofluorofentanyl, 4′-methyl acetyl 

fentanyl, b-methyl fentanyl, b′-phenyl 

fentanyl, ortho-fluorobutyryl fentanyl, 

ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, 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, orthofluorobutyryl fentanyl, ortho-methyl 

acetylfentanyl, ortho-methyl 

methoxyacetyl fentanyl, paramethylfentanyl, 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 orthofluorofentanyl, 4′-methyl acetyl 

fentanyl, b-methyl fentanyl, b′-phenyl 

fentanyl, ortho-fluorobutyryl fentanyl, 

ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, 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, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, 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 fentanylrelated 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, orthofluorobutyryl fentanyl, ortho-methyl 

acetylfentanyl, ortho-methyl 

methoxyacetyl fentanyl, paramethylfentanyl, 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 fentanylrelated substances as a class, which 

include 2′-fluoro ortho-fluorofentanyl, 

4′-methyl acetyl fentanyl, b-methyl 

fentanyl, b′-phenyl fentanyl, orthofluorobutyryl fentanyl, ortho-methyl 

acetylfentanyl, ortho-methyl 

methoxyacetyl fentanyl, paramethylfentanyl, 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, orthofluorobutyryl fentanyl, ortho-methyl 

acetylfentanyl, ortho-methyl 


jbell on DSKJLSW7X2PROD with PROPOSALS
12304 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Proposed Rules 

methoxyacetyl fentanyl, paramethylfentanyl, 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 orthofluorofentanyl, 4′-methyl acetyl 

fentanyl, b-methyl fentanyl, b′-phenyl 

fentanyl, ortho-fluorobutyryl fentanyl, 

ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, 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 


jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Proposed Rules 12305 

1See 63 FR 57356 (October 27, 1998). 

2As originally promulgated, the NOX 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). 

3CAIR had separate trading programs for annual 

sulfur dioxide emissions, seasonal NOX emissions, 

and annual NOX 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; NOX 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 (NOX) SIP Call obligations for 

large non-electricity generating units 

(non-EGUs), to repeal the State’s 

previously sunsetted NOX 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 NOX SIP Call, 

including alternative monitoring 

options for certain sources for NOX 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/commentingepa-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’’ (NOX SIP Call). The NOX SIP 

Call required eastern states, including 

Alabama, to submit SIPs that prohibit 

excessive emissions of ozone season 

NOX by implementing statewide 

emissions budgets.1 The NOX SIP Call 

addressed the good neighbor provision 

for the 1979 ozone NAAQS and was 

designed to mitigate the impact of 

transported NOX emissions, one of the 

precursors of ozone.2 EPA developed 

the NOX Budget Trading Program, an 

allowance trading program that states 

could adopt to meet their obligations 

under the NOX 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 NOX SIP Call also identified 

potential reductions from cement kilns 

and stationary internal combustion 

engines. 

To comply with the NOX 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 NOX

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 NOX

Budget Trading Program beginning in 

2004. In 2005, Alabama submitted, and 

EPA approved, a SIP revision to address 

additional emissions reductions 

required for the NOX 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) NOX

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 (PM2.5) NAAQS and was 

designed to mitigate the impact of 

transported NOX emissions with respect 

to ozone and PM2.5. 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 NOX

was implemented beginning in 2009, 

EPA discontinued administration of the 

NOX Budget Trading Program; however, 

the requirements of the NOX 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 


jbell on DSKJLSW7X2PROD with PROPOSALS