[Federal Register Volume 87, Number 216 (Wednesday, November 9, 2022)]
[Rules and Regulations]
[Pages 67550-67553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24155]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[Docket No. DEA-1046]


Specific Listing for 1-boc-4-AP, a Currently Controlled List I 
Chemical

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: The Drug Enforcement Administration (DEA) is establishing a 
specific listing and DEA Chemical Control Number for tert-butyl 4-
(phenylamino)piperidine-1-carboxylate (also known as 1-boc-4-AP; and 
CAS Number: 125541-22-2) and its salts as a list I chemical under the 
Controlled Substances Act. Although 1-boc-4-AP is not specifically 
listed as a list I chemical of the Controlled Substances Act with its 
own unique Chemical Control Number, it has been regulated as a list I 
chemical in the United States since May 15, 2020, as a carbamate of N-
phenylpiperidin-4-amine, a list I chemical. Therefore, DEA is simply 
amending the list I chemicals list in its regulations to include a 
separate listing for 1-boc-4-AP, a currently controlled list I 
chemical.

DATES: Effective date November 9, 2022.

FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical 
Evaluation Section, Diversion Control Division, Drug Enforcement 
Administration; Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION: tert-Butyl 4-(phenylamino)piperidine-1-
carboxylate (also known as 1-boc-4-AP) is a chemical that is 
structurally related to N-phenylpiperidin-4-amine (also known as N-
phenyl-4-piperidinamine, 4-anilinopiperidine, and 4-AP). N-
Phenylpiperidin-4-amine, including its amides, its carbamates, and its 
salts, is listed as a list I chemical at 21 CFR 1310.02(a). See 85 FR 
20822 (April 1, 2020) (effective May 15, 2020). The chemical structure 
of 1-boc-4-AP defines it as a carbamate of N-phenylpiperidin-4-amine. 
Accordingly, under 21 CFR 1310.02(b), 1-boc-4-AP, as a carbamate of N-
phenylpiperidin-4-amine, is and continues to be a regulated list I 
chemical.\1\
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    \1\ N-phenylpiperidin-4-amine, including its amides, its 
carbamates, and its salts, has been subject to list I chemical 
regulations since May 15, 2020, pursuant to a final rule (April 15, 
2020; 85 FR 20822).
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Legal Authority

    The Controlled Substances Act (CSA) and the Drug Enforcement 
Administration's (DEA) implementing regulations give the Attorney 
General, as delegated to the Administrator of DEA (Administrator), the 
authority to specify, by regulation, a chemical as a ``list I 
chemical.'' \2\ This term refers to a chemical that is used in 
manufacturing a controlled substance in violation of subchapter I 
(Control and Enforcement) of the CSA and is important to the 
manufacture of the controlled substance.\3\ The current list of all 
list I chemicals is available in 21 CFR 1310.02(a).
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    \2\ 21 U.S.C. 802(34) and 871(b) and 21 CFR 1310.02(c).
    \3\ 21 U.S.C. 802(34) and 21 CFR 1300.02(b).
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    In addition, the United States is a Party to the 1988 United 
Nations Convention Against Illicit Traffic in Narcotic Drugs and 
Psychotropic Substances (1988 Convention), December 20, 1988, 1582 
U.N.T.S. 95. Under Article 12 of the 1988 Convention, when the United 
States receives notification that a chemical has been added to Table I 
or Table II of the 1988 Convention, the United States is required to 
take measures it deems appropriate to monitor the manufacture and 
distribution of that chemical within the United States and to prevent 
its diversion, including measures related to international trade.

Background

    In a letter dated May 27, 2022, the United Nations Office on Drugs 
and Crime, in accordance with Article 12, paragraph 6 of the 1988 
Convention, informed the Permanent Mission of the United States of 
America to the United Nations (Vienna) that the Commission on Narcotic 
Drugs (CND) decided to place the chemical 1-boc-4-AP in Table I of the 
1988 Convention (CND Dec/65/5) at its 65th Session on March 16, 2022.

[[Page 67551]]

As discussed above in this final rule, 1-boc-4-AP--by virtue of being a 
carbamate of N-phenylpiperidin-4-amine--has been regulated as a list I 
chemical of the CSA since May 15, 2020.\4\ Therefore, all regulations 
and criminal sanctions applicable to list I chemicals have been and 
remain applicable to 1-boc-4-AP.
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    \4\ 85 FR 20822 (April 15, 2020).
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Effect of Action

    As discussed above, this rule does not affect the continuing status 
of 1-boc-4-AP as a list I chemical in any way. This action, as an 
administrative matter, merely establishes a separate, specific listing 
for 1-boc-4-AP in list I of the CSA and assigns a DEA chemical control 
number for the substance. This action will allow DEA to effectively 
monitor regulated transactions of 1-boc-4-AP, including the 
manufacture, distribution, importation, or exportation of 1-boc-4-AP, 
and to provide accurate reporting to the International Narcotics 
Control Board.

Chemical Mixtures of 1-boc-4-AP

    Pursuant to the final rule published on April 15, 2020,\5\ chemical 
mixtures containing 1-boc-4-AP have been and continue to be subject to 
regulatory requirements at any concentration--unless a manufacturer 
submits to DEA an application for exemption of a chemical mixture, DEA 
accepts the application for filing, and DEA exempts the chemical 
mixture in accordance with 21 CFR 1310.13 (Exemption of chemical 
mixtures by application).
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    \5\ 85 FR 20822.
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    Since even a small amount of 1-boc-4-AP can potentially yield a 
significant amount of controlled substances, DEA believes that the 
continued regulation of chemical mixtures containing any amount of 1-
boc-4-AP as a list I chemical is necessary to prevent its illicit 
extraction, isolation, and use. 1-boc-4-AP is already subject to 
domestic control under list I as a carbamate of N-phenylpiperidin-4-
amine, and DEA's current regulations provide that a chemical mixture 
containing any amount of N-phenylpiperidin-4-amine is a List I 
chemical. As a technical, conforming change in connection with the 
separate listing of 1-boc-4-AP, this rule modifies the ``Table of 
Concentration Limits'' in 21 CFR 1310.12(c) to reflect that a chemical 
mixture containing any amount of 1-boc-4-AP is subject to CSA chemical 
control provisions, including 21 CFR parts 1309, 1310, 1313, and 1316. 
No additional requirements are being imposed.
    DEA has implemented an application process to exempt certain 
chemical mixtures from the requirements of the CSA and its implementing 
regulations.\6\ Manufacturers may submit an application for exemption 
for those mixtures that do not meet the criteria set forth in 21 CFR 
1310.12(d) for an automatic exemption. Pursuant to 21 CFR 1310.13(a), 
DEA may grant exempt status to a chemical mixture by publishing a final 
rule in the Federal Register, if DEA determines that: (1) The mixture 
is formulated in such a way that it cannot be easily used in the 
illicit production of a controlled substance, and (2) the listed 
chemical or chemicals cannot be readily recovered.
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    \6\ 21 CFR 1310.13.
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Requirements for Handling List I Chemicals

    The listing of 1-boc-4-AP as a list I chemical continues to subject 
handlers (manufacturers, distributors, importers, and exporters) and 
proposed handlers to all of the regulatory controls and administrative, 
civil, and criminal actions applicable to the manufacture, 
distribution, importation, and exportation of a list I chemical. Since 
May 15, 2020, persons handling 1-boc-4-AP, including regulated chemical 
mixtures containing 1-boc-4-AP, have been required to comply with list 
I chemical regulations, including the following:
    1. Registration. Any person who handles (manufactures, distributes, 
imports, or exports), or proposes to engage in such handling, of 1-boc-
4-AP or a chemical mixture containing 1-boc-4-AP, must obtain a 
registration pursuant to 21 U.S.C. 822, 823, 957, and 958. Regulations 
describing registration for list I chemical handlers are set forth in 
21 CFR part 1309.
    2. Records and Reports. Every DEA registrant must maintain records 
and submit reports to DEA with respect to 1-boc-4-AP pursuant to 21 
U.S.C. 830 and in accordance with 21 CFR 1310. Pursuant to 21 CFR 
1310.04, a record must be made and maintained for two years after the 
date of a transaction involving a listed chemical, provided the 
transaction is a regulated transaction.
    3. Importation and Exportation. All importation and exportation of 
1-boc-4-AP must be done in compliance with 21 U.S.C. 957, 958, and 971 
and in accordance with 21 CFR part 1313.
    4. Security. All applicants and registrants must provide effective 
controls against theft and diversion in accordance with 21 CFR 1309.71-
1309.73.
    5. Administrative Inspection. Places, including factories, 
warehouses, or other establishments and conveyances, where registrants 
or other regulated persons may lawfully hold, manufacture, distribute, 
or otherwise dispose of a list I chemical or where records relating to 
those activities are maintained, are controlled premises as defined in 
21 U.S.C. 880(a) and 21 CFR 1316.02(c). The CSA allows for 
administrative inspections of these controlled premises as provided in 
21 CFR part 1316, subpart A.\7\
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    \7\ 21 U.S.C. 880.
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    6. Liability. Any activity involving 1-boc-4-AP not authorized by, 
or in violation of, the CSA is unlawful, and would subject the person 
to administrative, civil, and/or criminal action.

Regulatory Analyses

Administrative Procedure Act

    An agency may find good cause to exempt a rule from certain 
provisions of the Administrative Procedure Act (APA) (5 U.S.C. 553), 
including notice of proposed rulemaking and the opportunity for public 
comment, if it is determined to be unnecessary, impracticable, or 
contrary to the public interest.
    As discussed above, 1-boc-4-AP is currently and continues to be 
regulated as a list I chemical as a carbamate of N-phenylpiperidin-4-
amine.
    Pursuant to 5 U.S.C. 553(b)(3)(B), DEA finds that notice and 
comment rulemaking is unnecessary and that good cause exists to 
dispense with these procedures. The addition of a separate listing for 
1-boc-4-AP and its DEA chemical control number in the list of list I 
chemicals in 21 CFR 1310.02(a) makes no substantive difference in the 
status of this chemical as a list I chemical, but instead is ``a minor 
or merely technical amendment in which the public is not particularly 
interested.'' National Nutritional Foods Ass'n v. Kennedy, 572 F.2d 
377, 385 (2d Cir. 1978) (quoting S. Rep. No. 79-752, at 200 (1945)). 
See also Utility Solid Waste Activities Group v. E.P.A., 236 F.3d 749, 
755 (D.C. Cir. 2001) (the ``unnecessary'' prong ``is confined to those 
situations in which the administrative rule is a routine determination, 
insignificant in nature and impact, and inconsequential to the industry 
and to the public'') (internal quotations and citation omitted). This 
rule is a ``minor'' or ``technical'' amendment to 21 CFR 1310 as it is 
``insignificant in nature and impact, and inconsequential to the 
industry and

[[Page 67552]]

public.'' Therefore, publishing a notice of proposed rulemaking and 
soliciting public comment are unnecessary.
    In addition, because 1-boc-4-AP is already subject to domestic 
control under list I as a carbamate of N-phenylpiperidin-4-amine and no 
additional requirements are being imposed through this action, DEA 
finds good cause exists to make this rule effective immediately upon 
publication in accordance with 5 U.S.C. 553(d)(3). DEA is concerned 
that delaying the effective date of this rule potentially could cause 
confusion regarding the regulatory status of 1-boc-4-AP. 1-boc-4-AP is 
currently regulated as a list I chemical, and this level of control 
does not change with this rulemaking.

Executive Orders 12866 and 13563, Regulatory Planning and Review and 
Improving Regulation and Regulatory Review

    This rule was developed in accordance with the principles of 
Executive Orders (E.O.) 12866 and 13563. This rule is not a significant 
regulatory action under E.O. 12866. 1-boc-4-AP is already regulated as 
a list I chemical in the United States, as a carbamate of the list I 
chemical N-phenylpiperidin-4-amine. In this final rule, DEA is merely 
making an administrative change by amending its regulations to 
separately list 1-boc-4-AP as a list I chemical and to assign the DEA 
chemical control number 8336 to this chemical. A separate listing for 
1-boc-4-AP will not alter the status of 1-boc-4-AP as a list I 
chemical. Accordingly, this rule has not been reviewed by the Office of 
Management and Budget (OMB).

Executive Order 12988, Civil Justice Reform

    This 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 rulemaking does not have federalism implications warranting 
the application of E.O. 13132. The 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 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 Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to 
rules that are subject to notice and comment under section 553(b) of 
the APA or other laws. As noted in the above section regarding the 
applicability of the APA, DEA determined that there is good cause to 
exempt this final rule from notice and comment. Consequently, the RFA 
does not apply.

Unfunded Mandates Reform Act of 1995 (UMRA)

    In accordance with the UMRA, 2 U.S.C. 1501 et seq., DEA has 
determined and certifies that this rule will 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 
$100,000,000 or more (adjusted annually for inflation) in any 1 year * 
* *.'' Therefore, neither a Small Government Agency Plan nor any other 
action is required under the UMRA.

Paperwork Reduction Act

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

Congressional Review Act

    This final rule is not a major rule as defined by the Congressional 
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is 
submitting a copy of this final rule to both Houses of Congress and to 
the Comptroller General.

List of Subjects 21 CFR Part 1310

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

    Accordingly, for the reasons set forth in the preamble, DEA amends 
21 CFR part 1310 as follows:

PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN 
MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES

0
1. The authority citation for 21 CFR part 1310 continues to read as 
follows:

    Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.


0
2. In Sec.  1310.02, add reserved paragraph (a)(38) and paragraph 
(a)(39) to read as follows:


Sec.  1310.02  Substances covered.

* * * * *
    (a) * * *
    (38) [Reserved]

 (39) 1-boc-4-AP (tert-butyl 4-(phenylamino)piperidine-1-           8336
 carboxylate) and its salts......................................
 

* * * * *

0
3. In Sec.  1310.04:
0
a. Redesignate paragraphs (g)(1)(iii) through (xviii) as paragraphs 
(g)(1)(iv) through (xix), respectively; and
0
b. Add new paragraph (g)(1)(iii).
    The addition reads as follows:


Sec.  1310.04  Maintenance of records.

* * * * *
    (g) * * *
    (1) * * *
* * * * *
    (iii) 1-boc-4-AP (tert-butyl 4-(phenylamino)piperidine-1-
carboxylate) and its salts.
* * * * *

0
4. Section 1310.12 is amended by adding in alphabetical order in the 
table in paragraph (c) an entry for 1-boc-4-AP (tert-butyl 4-
(phenylamino)piperidine-1-carboxylate) and its salts to read as 
follows:


Sec.  1310.12  Exempt chemical mixtures.

* * * * *
    (c) * * *

[[Page 67553]]



                                          Table of Concentration Limits
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                                           DEA chemical
                                             code No.            Concentration            Special conditions
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                                                List I Chemicals
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                                                  * * * * * * *
1-boc-4-AP (tert-butyl 4-                           8336  Not exempt at any           Chemical mixtures
 (phenylamino)piperidine-1-carboxylate)                    concentration.              containing any amount of
 and its salts.                                                                        1-boc-4-AP (tert-butyl 4-
                                                                                       (phenylamino)piperidine-1-
                                                                                       carboxylate) and its
                                                                                       salts are not exempt.
 
                                                  * * * * * * *
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* * * * *

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
November 1, 2022, by Administrator Anne Milgram. That document with the 
original signature and date is maintained by DEA. For administrative 
purposes only, and in compliance with requirements of the Office of the 
Federal Register, the undersigned DEA Federal Register Liaison Officer 
has been authorized to sign and submit the document in electronic 
format for publication, as an official document of DEA. This 
administrative process in no way alters the legal effect of this 
document upon publication in the Federal Register.

Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-24155 Filed 11-8-22; 8:45 am]
BILLING CODE 4410-09-P