[Federal Register Volume 82, Number 134 (Friday, July 14, 2017)]
[Rules and Regulations]
[Pages 32457-32461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14878]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[Docket No. DEA-379]
RIN 1117-ZA04


Designation of Alpha-Phenylacetoacetonitrile (APAAN), a Precursor 
Chemical Used in the Illicit Manufacture of Phenylacetone, 
Methamphetamine, and Amphetamine, as a List I Chemical

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: The Drug Enforcement Administration (DEA) is finalizing the 
designation of the chemical alpha-phenylacetoacetonitrile (APAAN) and 
its salts, optical isomers, and salts of optical isomers, as a list I 
chemical under the Controlled Substances Act (CSA). The DEA proposed 
control of APAAN, due to its use in clandestine laboratories to 
illicitly manufacture the schedule II controlled substances 
phenylacetone (also known as phenyl-2-propanone or P2P), 
methamphetamine, and amphetamine. This rulemaking finalizes, without 
change, the control of APAAN as a list I chemical.
    This action does not establish a threshold for domestic and 
international transactions of APAAN. As such, all transactions 
involving APAAN, regardless of size, shall be regulated. In addition, 
chemical mixtures containing APAAN are not exempt from regulatory 
requirements at any concentration. Therefore, all transactions of 
chemical mixtures containing any quantity of APAAN shall be regulated 
pursuant to the CSA. However, manufacturers may submit an application 
for exemption for those mixtures that do not qualify for automatic 
exemption.

DATES: Effective date: August 14, 2017.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION:

Legal Authority

    The Controlled Substances Act (CSA) gives the Attorney General the 
authority to specify, by regulation, chemicals as list I or list II 
chemicals. 21 U.S.C. 802 (34) and (35). A ``list I chemical'' is a 
chemical that is used in manufacturing a controlled substance in 
violation of title II of the CSA, and is important to the manufacture 
of the controlled substance. 21 U.S.C. 802(34). A ``list II chemical'' 
is a chemical (other than a list I chemical) that is used in 
manufacturing a controlled substance in violation of title II of the 
CSA. 21 U.S.C. 802(35). The current list of all listed chemicals is 
published at 21 CFR 1310.02. Pursuant to 28 CFR 0.100(b), the Attorney 
General has delegated his authority to designate list I and list II 
chemicals to the Administrator of the Drug Enforcement Administration.
    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). When the United States 
receives notification that a chemical has been added to Table I or 
Table II of the 1988 Convention pursuant to article 12, 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. In addition, the 1988 Convention requires 
the United States to take other specified measures related to that 
chemical, including measures related to its international trade.

Background

    By a letter dated April 9, 2014, the Secretary-General of the 
United Nations informed the United States Government that the chemical 
alpha-phenylacetoacetonitrile (APAAN) was added to Table I of the 1988 
Convention. This letter was prompted by a March 19, 2014, decision at 
the 57th Session of the United Nations Commission on Narcotic Drugs 
(CND) to add APAAN to Table I. As a Party to the 1988 Convention, the 
United States is obligated, pursuant to article 12, to take measures it 
deems appropriate to monitor the manufacture and distribution of APAAN 
within the United States and to prevent its diversion. Article 12 also 
obligates the United States to take other specified measures related to 
APAAN, including measures related to its international trade. By 
designating APAAN, which is a primary precursor for the manufacture of 
phenylacetone (also known as phenyl-2-propanone (P2P) or benzyl methyl 
ketone), methamphetamine, and amphetamine, as a list I chemical, the 
United States will fulfill its obligations under the 1988 Convention.

Designation of APAAN and Its Salts, Optical Isomers, and Salts of 
Optical Isomers as a List I Chemical

    On December 12, 2016, DEA published a Notice of Proposed Rulemaking 
(NPRM) proposing control of APAAN, due to its use in clandestine 
laboratories to illicitly manufacture the schedule II controlled 
substances phenylacetone (also known as phenyl-2-propanone or P2P), 
methamphetamine, and amphetamine. 81 FR 89402. In response to the NPRM, 
only one comment was received. This comment was supportive of the DEA's 
proposed control of APAAN. As such, this rulemaking finalizes the 
control of APAAN as a list I chemical.
    On the effective date of this final rule, handlers of APAAN shall 
be subject to the chemical regulatory provisions of the CSA, including 
21 CFR parts 1309, 1310, 1313, and 1316. Since even a small amount of 
APAAN can make a significant amount of P2P, this action does not 
establish a threshold for domestic and import transactions of APAAN in 
accordance with the provisions of 21 CFR 1310.04(g). Therefore, all 
APAAN transactions, regardless of size, will be regulated

[[Page 32458]]

transactions as defined in 21 CFR 1300.02(b). As such, all APAAN 
transactions will be subject to recordkeeping, reporting, import and 
export controls, and other CSA chemical regulatory requirements. In 
addition, each regulated bulk manufacturer shall submit manufacturing, 
inventory, and use data on an annual basis.

Chemical Mixtures of APAAN

    Under this final rulemaking, chemical mixtures containing APAAN 
shall not be exempt from regulatory requirements at any concentration, 
unless an application for exemption of a chemical mixture is submitted 
by an APAAN manufacturer, and the application is reviewed and accepted 
and the mixture exempted by the DEA under 21 CFR 1310.13. Therefore, 
all chemical mixtures containing any quantity of APAAN shall be subject 
to CSA control, unless the APAAN manufacturer is granted an exemption 
by the application process in accordance with 21 CFR 1310.13. This rule 
modifies the ``Table of Concentration Limits'' in 21 CFR 1310.12(c) to 
reflect the fact that chemical mixtures containing any amount of APAAN 
are subject to CSA chemical control provisions.

Exemption by Application Process

    The DEA has implemented an application process to exempt certain 
chemical mixtures from the requirements of the CSA and its implementing 
regulations. 21 CFR 1310.13. Manufacturers may submit an application 
for exemption for those mixtures that do not qualify for automatic 
exemption. Exemption status may be granted if the DEA determines that 
the mixture is formulated in such a way that it cannot be easily used 
in the illicit production of a controlled substance, and that the 
listed chemical or chemicals cannot be readily recovered. 21 CFR 
1310.13(a)(1)-(2).

Requirements for Handling List I Chemicals

    The designation of APAAN as a list I chemical shall subject APAAN 
handlers (manufacturers, distributors, importers, and exporters) to all 
of the regulatory controls and administrative, civil, and criminal 
actions applicable to the manufacture, distribution, importing, and 
exporting of a list I chemical. Upon publication of this final rule, 
persons handling APAAN, including regulated chemical mixtures 
containing APAAN, shall be required to comply with the following list I 
chemical regulations:
    1. Registration. Any person who manufactures, distributes, imports, 
or exports APAAN, or proposes to engage in the manufacture, 
distribution, importation, or exportation of APAAN, must obtain a 
registration pursuant to 21 U.S.C. 822, 823, 957, 958. Regulations 
describing registration for list I chemical handlers are set forth in 
21 CFR part 1309.
    Upon publication of this final rule, any person manufacturing, 
distributing, importing, or exporting APAAN or a chemical mixture 
containing APAAN will become subject to the registration requirement 
under the CSA. The DEA recognizes, however, that it is not possible for 
persons who are subject to the registration requirement to immediately 
complete and submit an application for registration and for the DEA to 
immediately issue registrations for those activities. Therefore, to 
allow continued legitimate commerce in APAAN, the DEA is establishing 
in 21 CFR 1310.09, a temporary exemption from the registration 
requirement for persons desiring to engage in activities with APAAN, 
provided that the DEA receives a properly completed application for 
registration or exemption of a chemical mixture on or before August 14, 
2017. The temporary exemption for such persons will remain in effect 
until the DEA takes final action on their application for registration 
or application for exemption of a chemical mixture.
    The temporary exemption applies solely to the registration 
requirement; all other chemical control requirements, including 
recordkeeping and reporting, would become effective on the effective 
date of this final rule. Therefore, all transactions of APAAN and 
chemical mixtures containing APAAN will be regulated while an 
application for registration or exemption is pending. This is necessary 
because not regulating these transactions could result in increased 
diversion of chemicals desirable to drug traffickers.
    Additionally, the temporary exemption does not suspend applicable 
federal criminal laws relating to APAAN, nor does it supersede State or 
local laws or regulations. All handlers of APAAN must comply with 
applicable State and local requirements in addition to the CSA 
regulatory controls.
    2. Records and Reports. Every DEA registrant must maintain records 
and reports with respect to APAAN pursuant to 21 U.S.C. 830 and in 
accordance with 21 CFR part 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.
    Each regulated bulk manufacturer of a listed chemical must submit 
manufacturing, inventory, and use data on an annual basis. 21 CFR 
1310.05(d). Existing standard industry reports containing the required 
information will be acceptable, provided the information is separate or 
readily retrievable from the report.
    21 CFR 1310.05(a) requires that each regulated person shall report 
to the DEA any regulated transaction involving an extraordinary 
quantity of a listed chemical, an uncommon method of payment or 
delivery, or any other circumstance that the regulated person believes 
may indicate that the listed chemical will be used in violation of the 
CSA and its corresponding regulations. Regulated persons are also 
required to report any proposed regulated transaction with a person 
whose description or other identifying characteristic the 
Administration has previously furnished to the regulated person; any 
unusual or excessive loss or disappearance of a listed chemical under 
the control of the regulated person; any in-transit loss in which the 
regulated person is the supplier; and any domestic regulated 
transaction in a tableting or encapsulating machine.
    3. Importation and Exportation. All importation and exportation of 
APAAN must comply with 21 U.S.C. 957, 958, and 971 and be 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 (21 U.S.C. 880) allows 
for administrative inspections of these controlled premises as provided 
in 21 CFR part 1316, subpart A.
    6. Liability. Any activity involving APAAN not authorized by, or in 
violation of, the CSA, will be unlawful, and may subject the person to 
administrative, civil, and/or criminal action.

Regulatory Analyses

Executive Orders 12866 and 13563

    This final rulemaking, which adds APAAN as a list I chemical, has 
been developed in accordance with the

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principles of Executive Orders 12866 and 13563. The DEA followed the 
principles of these Executive Orders, even though it has been 
determined that this action is not a significant regulatory action.
    To determine whether this action is a significant regulatory 
action, the DEA utilized a least cost option analysis. At the outset, 
the DEA determined that the primary costs of this rule would come from 
complying with the registration, recordkeeping, reporting, and export 
and import requirements set forth in the CSA. Therefore, under the 
least cost option, an entity would choose to discontinue the sale of 
APAAN if proceeds from the sale are less than the cost of complying 
with the rule.
    The DEA has not identified any industrial uses of APAAN by domestic 
entities and its potential usage appears to be limited to research. 
Based on independent research following a 2013 United Nations 
Questionnaire/Survey on APAAN, the DEA identified three entities that 
have each imported APAAN. Two of the three entities had average annual 
sales of APAAN totaling $13 during the analysis period. The third 
entity had average annual sales of APAAN totaling $1,440 during the 
same period. Other chemical distributors list APAAN in their chemical 
catalogs. However, these entities do not manufacture APAAN, instead 
opting to purchase APAAN from international sources to fill special 
orders. These entities do not stock APAAN in inventory and the vast 
majority had no previous sales of APAAN.
    The registration fee for importers of a list I chemical is $1,523 
per year. Based on the least cost option, these three entities would 
choose to discontinue the sale of APAAN because complying with the rule 
is more costly. Thus, the annual economic impact of the rule is $1,467 
(total annual sales of APAAN from the three affected entities). 
Therefore, this is evidence that this rule will not have an annual 
effect on the economy of $100 million or more and is not a significant 
regulatory action.

Executive Order 13771

    Executive Order 13771, titled ``Reducing Regulation and Controlling 
Regulatory Costs,'' was issued on January 30, 2017 and published in the 
Federal Register on February 3, 2017. 82 FR 9339. Section 2(a) of 
Executive Order 13771 requires an agency, unless prohibited by law, to 
identify at least two existing regulations to be repealed when the 
agency publicly proposes for notice and comment or otherwise 
promulgates a new regulation. In furtherance of this requirement, 
section 2(c) of Executive Order 13771 requires that the new incremental 
costs associated with new regulations, to the extent permitted by law, 
be offset by the elimination of existing costs associated with at least 
two prior regulations. The interim guidance from the Office of 
Management and Budget (OMB), issued on February 2, 2017, explains that 
for Fiscal Year 2017 the above requirements only apply to each new 
``significant regulatory action that imposes costs.'' Because the DEA 
has determined that this final rulemaking is not a ``significant 
regulatory action,'' the requirements of Executive Order 13771 have not 
been triggered.

Executive Order 12988

    This rule meets the applicable standards set forth in sections 3(a) 
and 3(b)(2) of Executive Order 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

    This rulemaking does not have federalism implications warranting 
the application of Executive Order 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

    This rule does not have tribal implications warranting the 
application of Executive Order 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 (RFA), 5 U.S.C. 601-612, has reviewed this rule and by 
approving it certifies that it will not have a significant economic 
impact on a substantial number of small entities. The purpose of this 
rule is to designate APAAN as a list I chemical under the CSA. No less 
restrictive measures (i.e., non-control or control in list II) would 
enable the DEA to meet its statutory obligation under the CSA and its 
international obligations of the 1988 Convention. The DEA estimates 
that this rule affects three small entities. As discussed above, the 
DEA compared the dollar value of APAAN sales to the cost of 
registration. Further, the DEA assumed that if the cost of registration 
is more than the dollar value of APAAN sales, then each entity would 
discontinue the sale of APAAN.
    Two entities earned $13 in annual sales of APAAN while the third 
entity earned $1,440 in annual sales of APAAN. The cost of registration 
alone is $1,523 for each entity. Therefore, the DEA anticipates that 
each entity will discontinue the sale of APAAN because the cost of 
compliance is greater than the annual sales. As a result, the annual 
economic impact of the rule is $1,467.
    Using 1% of annual revenue as the criteria for significant economic 
impact, the DEA estimates that none of the three small entities will 
experience a significant economic impact. The cost of the rule as a 
percentage of annual revenue for the three entities is, 0.00044%, 
0.00036%, and 0.038%, respectively, which is less than 1% of the 
entities' annual income. Therefore, the rule will not have a 
significant effect on a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    On the basis of information contained in the ``Regulatory 
Flexibility Act'' section above, the DEA has determined and certifies 
pursuant to the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 
1501 et seq., 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 
$100,000,000 or more (adjusted for inflation) in any one year. 
Therefore, neither a Small Government Agency Plan nor any other action 
is required under provisions of the UMRA of 1995.

Paperwork Reduction Act

    This action does not impose a new collection of information 
requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-
3521. The DEA does not anticipate that it will receive new registration 
applications for the purpose of engaging in transactions involving this 
chemical. The transactions in this chemical of which the DEA is aware 
are very small, and it does not appear to the DEA that it would be 
economically justifiable because DEA believes there is no legitimate 
market for manufacturing or engaging in commercial transactions in this 
chemical. This action would not impose recordkeeping or reporting 
requirements on State or local governments, individuals, businesses, or 
organizations. An agency may not

[[Page 32460]]

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 rule is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act). This rule will not result in an annual 
effect on the economy of $100 million or more. It will not cause a 
major increase in costs or prices; or significant adverse effects on 
competition, employment, investment, productivity, innovation, or on 
the ability of the United States-based companies to compete with 
foreign based companies in domestic and export markets. However, the 
DEA has submitted a copy of this final rule to both Houses of Congress 
and to the Comptroller General.

List of Subjects in 21 CFR Part 1310

    Drug traffic control, Exports, Imports, Reporting and recordkeeping 
requirements.

    Accordingly, for the reasons set forth in the preamble, part 1310 
of title 21 of the Code of Federal Regulations is amended 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 part 1310 continues to read as follows:

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


0
2. Amend Sec.  1310.02 by redesignating paragraphs (a)(1) through 
(a)(30) as paragraphs (a)(2) through (a)(31), respectively, and adding 
a new paragraph (a)(1) to read as follows:


Sec.  1310.02  Substances covered.

* * * * *
    (a) * * *

(1) Alpha-phenylacetoacetonitrile and its salts, optical            8512
 isomers, and salts of optical isomers (APAAN)..........
 

* * * * *

0
 3. Amend Sec.  1310.04 by redesignating paragraphs (g)(1)(i) through 
(g)(1)(x) as paragraphs (g)(1)(ii) through (g)(1)(xi), respectively, 
and adding a new paragraph (g)(1)(i) to read as follows:


Sec.  1310.04  Maintenance of records.

* * * * *
    (g) * * *
    (1) * * *
    (i) Alpha-phenylacetoacetonitrile and its salts, optical isomers, 
and salts of optical isomers (APAAN)
* * * * *

0
4. Amend Sec.  1310.09 by adding paragraph (n) to read as follows:


Sec.  1310.09  Temporary exemption from registration.

* * * * *
    (n)(1) Each person required under sections 302 and 1007 of the Act 
(21 U.S.C. 822, 957) to obtain a registration to manufacture, 
distribute, import, or export regulated alpha-phenylacetoacetonitrile 
(APAAN) and its salts, optical isomers, and salts of optical isomers, 
including regulated chemical mixtures pursuant to Sec.  1310.12, is 
temporarily exempted from the registration requirement, provided that 
the DEA receives a properly completed application for registration or 
application for exemption for a chemical mixture containing alpha-
phenylacetoacetonitrile (APAAN) and its salts, optical isomers, and 
salts of optical isomers, pursuant to Sec.  1310.13 on or before August 
14, 2017. The exemption will remain in effect for each person who has 
made such application until the Administration has approved or denied 
that application. This exemption applies only to registration; all 
other chemical control requirements set forth in the Act and parts 
1309, 1310, 1313, and 1316 of this chapter remain in full force and 
effect.
    (2) Any person who manufactures, distributes, imports or exports a 
chemical mixture containing alpha-phenylacetoacetonitrile (APAAN) and 
its salts, optical isomers, and salts of optical isomers whose 
application for exemption is subsequently denied by the DEA must obtain 
a registration with the DEA. A temporary exemption from the 
registration requirement will also be provided for those persons whose 
applications for exemption are denied, provided that the DEA receives a 
properly completed application for registration on or before 30 days 
following the date of official DEA notification that the application 
for exemption has been denied. The temporary exemption for such persons 
will remain in effect until the DEA takes final action on their 
registration application.

0
5. Amend Sec.  1310.12(c) by adding in alphabetical order an entry 
``Alpha-phenylacetoacetonitrile, and its salts, optical isomers, and 
salts of optical isomers. (APAAN)'' in the table ``Table of 
Concentration Limits'' to read as follows:


Sec.  1310.12   Exempt chemical mixtures.

* * * * *
    (c) * * *

                                          Table of Concentration Limits
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                                           DEA chemical
                                             code No.            Concentration            Special conditions
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Alpha-phenylacetoacetonitrile, and its             8512   Not exempt at any           Chemical mixtures
 salts, optical isomers, and salts of                      concentration.              containing any amount of
 optical isomers. (APAAN).                                                             APAAN are not exempt.
 
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    Dated: July 10, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-14878 Filed 7-13-17; 8:45 am]
BILLING CODE 4410-09-P