Rule2022-24155
Specific Listing for 1-boc-4-AP, a Currently Controlled List I Chemical
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 9, 2022
Effective
November 9, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 216 (Wednesday, November 9, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
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</html>Indexed from Federal Register on November 9, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.