[Federal Register Volume 81, Number 238 (Monday, December 12, 2016)]
[Proposed Rules]
[Pages 89402-89407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29523]
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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: Notice of proposed rulemaking.
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SUMMARY: The Drug Enforcement Administration is proposing to designate
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. APAAN is used in clandestine
laboratories to illicitly manufacture the schedule II controlled
substances phenylacetone (also known as phenyl-2-propanone or P2P),
methamphetamine, and amphetamine and is important to the manufacture of
these controlled substances. This action does not propose the
establishment of a threshold for domestic and international
transactions of APAAN. As such, all transactions involving APAAN,
regardless of size, would be regulated. In addition, this action
proposes that chemical mixtures containing APAAN would not be exempt
from regulatory requirements at any concentration. Therefore, all
transactions of chemical mixtures containing any quantity of APAAN
would be regulated pursuant to the Controlled Substances Act.
DATES: Electronic comments must be submitted, and written comments must
be postmarked, on or before January 11, 2017. Commenters should be
aware that the electronic Federal Docket Management System will not
accept comments after 11:59 p.m. Eastern Time on the last day of the
comment period.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-379'' on all correspondence, including any
attachments.
The Drug Enforcement Administration 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. Paper comments that duplicate the electronic submission are
not necessary and are discouraged. 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/ODW, 8701 Morrissette Drive, Springfield,
Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion
Control, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received 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 name, address, etc.)
voluntarily submitted by the commenter. The Freedom of Information Act
(FOIA) applies to all comments received. If you want to
[[Page 89403]]
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
generally 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 proposed rule is available at http://www.regulations.gov for easy reference.
Legal Authority
The DEA implements and enforces titles II and III of the
Comprehensive Drug Abuse Prevention and Control Act of 1970, as
amended. 21 U.S.C. 801-971. Titles II and III are referred to as the
``Controlled Substances Act'' and the ``Controlled Substances Import
and Export Act,'' respectively, and are collectively referred to as the
``Controlled Substances Act'' or the ``CSA'' for the purpose of this
action. The DEA publishes the implementing regulations for these
statutes in title 21 of the Code of Federal Regulations (CFR), chapter
II. The CSA and its implementing regulations are designed to prevent,
detect, and eliminate the diversion of controlled substances and listed
chemicals into the illicit market while providing for the legitimate
medical, scientific, research, and industrial needs of the United
States. Controlled substances have the potential for abuse and
dependence and are controlled to protect the public health and safety.
The 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 her 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 as a list I chemical, the United States will fulfill
its obligations under the 1988 Convention.
APAAN is a primary precursor for the manufacture of phenylacetone
(also known as phenyl-2-propanone (P2P) or benzyl methyl ketone),
methamphetamine, and amphetamine. Throughout the 1970s, methamphetamine
was illicitly produced in the United States, primarily with the
precursor chemical P2P. In response to the illicit use of P2P, the DEA
controlled P2P as a schedule II controlled substance in 1980 pursuant
to the ``immediate precursor'' provisions of the CSA, specifically 21
U.S.C. 811(e). Clandestine laboratory operators responded by developing
a variety of synthetic methods for producing P2P.
Congress and the DEA responded with the implementation of controls
on P2P precursor chemicals such as phenylacetic acid (and its salts and
esters), acetic anhydride, benzyl cyanide, benzaldehyde, and
nitroethane, all of which are controlled as listed chemicals. 21 CFR
1310.02 (a)-(b). However, clandestine laboratory operators soon
adjusted to these controls on P2P (and its precursors). As an
alternative for methamphetamine production, clandestine laboratory
operators used the precursors ephedrine and pseudoephedrine, and as an
alternative for amphetamine production, they used the precursor
phenylpropanolamine.
This led Congress and the DEA to implement stringent controls on
the manufacture, distribution, importation, and exportation of
ephedrine (its salts, optical isomers, and salts of optical isomers),
pseudoephedrine, and phenylpropanolamine (controlled as list I
chemicals), and pharmaceutical products containing these chemicals. The
international community soon took similar measures.
With the growing problem of illicit drug production, the issue of
precursor chemical control has gained global attention. International
efforts to prevent the illicit production of amphetamine-type
stimulants (including amphetamine and methamphetamine), and
international control of precursors, have made significant progress.
International controls on precursors were established under article 12
of the 1988 Convention.\1\ The 1988 Convention established two
categories of controlled illicit drug precursor substances: Table I and
Table II.\2\ Two international entities have played a crucial role in
this effort: The United Nations Commission on Narcotic Drugs (CND)
[[Page 89404]]
and the International Narcotics Control Board.
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\1\ Dec. 20, 1988, 1582 U.N.T.S. 95.
\2\ Table I and Table II are annexed to the Convention.
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In response to domestic and international controls on amphetamine
and methamphetamine precursors, clandestine laboratory operators have
continued to explore alternate methods of making these illicit drugs,
including developing techniques to manufacture their own precursors and
diverting other precursors to produce these precursors. This has led
clandestine laboratory operators to utilize the P2P precursor APAAN.
Clandestine laboratory operators currently use APAAN to manufacture
P2P, which they then convert to methamphetamine and amphetamine.
APAAN
APAAN also goes by the names: 1-cyano-1-phenylpropan-2-one; 2-
phenylacetoacetonitrile; 2-acetyl-2-phenylacetonitrile; alpha-acetyl-
benzene acetonitrile; phenyl aceto-acetonitrile; [alpha]-
acetylphenylacetonitrile; 3-oxo-2-phenylbutanenitrile; CAS Number:
4468-48-8; and Identification Number: UN3439.
The DEA has long been aware of APAAN's potential illicit use as a
primary precursor for the production of P2P. The synthesis of P2P from
benzyl cyanide involves the manufacture of APAAN prior to the final
synthesis of P2P. Therefore, benzyl cyanide and APAAN share the same
synthetic pathway in the production of P2P. In the late 1980's the DEA
advocated for the Congressional control of the P2P precursor benzyl
cyanide as a list I chemical.
Due to the lack of industrial uses of APAAN, there has historically
been a lack of available product for potential diversion. In recent
years, however, large international seizures of APAAN have been made,
primarily in Europe, which suggest there is a ready supply of APAAN
from international chemical manufacturers.
While the DEA has encountered one clandestine laboratory in the
United States utilizing this synthetic pathway in recent years, the
DEA's European counterparts have made a large number of APAAN seizures.
For calendar years 2009 through 2014, the European Commission has
documented at least 113 seizures and stop shipments, involving over 80
metric tons of APAAN. Many of these seizures were associated with
seizures of P2P and amphetamine. Many of these APAAN seizures
originated from chemical suppliers based in Asia.
The DEA has determined that APAAN is now readily available from
commercial chemical suppliers and has identified 34 potential suppliers
in China, 6 potential suppliers in the United States, 2 in Russia, and
1 each in Bulgaria, Cameroon, the Czech Republic, France, and Germany.
The DEA is concerned about the ease with which APAAN serves as a
precursor chemical for illicit controlled substance production and with
the international trafficking in this chemical. The international
community echoes this concern. As noted above, the CND has added APAAN
to Table I of the 1988 Convention. Therefore, the DEA is proposing the
designation of APAAN as a list I chemical.
Proposed Designation of APAAN and Its Salts, Optical Isomers, and Salts
of Optical Isomers as a List I Chemical
The CSA, specifically 21 U.S.C. 802(34), and its implementing
regulations at 21 CFR 1310.02(c), provides the Attorney General with
the authority to specify, by regulation, a chemical as a ``list I
chemical'' if the chemical is used in the manufacture of a controlled
substance in violation of the CSA and is important to the manufacture
of these controlled substances. Clandestine laboratory operators are
using APAAN as the precursor material for the illicit manufacture of
P2P, methamphetamine, and amphetamine. These three substances are all
controlled substances under the CSA. APAAN is a primary precursor for
P2P, for subsequent conversion to methamphetamine or amphetamine.
Therefore, APAAN is important to the manufacture of a controlled
substance. This action proposes the designation of APAAN as a list I
chemical because the DEA finds that APAAN is used in the illicit
manufacture of these controlled substances and is important to the
illicit manufacture of these controlled substances.
If finalized, handlers of APAAN would become 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 propose the
establishment of a threshold for domestic and import transactions of
APAAN in accordance with the provisions of 21 CFR 1310.04(g).
Therefore, the DEA is proposing that all APAAN transactions, regardless
of size, will be regulated transactions as defined in 21 CFR
1300.02(b). As such, if finalized, 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
This rulemaking also proposes that chemical mixtures containing
APAAN would 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
(Exemption by Application Process). Since even a small amount of APAAN
yields a significant amount of P2P, the DEA believes that regulation of
chemical mixtures containing any amount of APAAN is necessary to
prevent the illicit extraction, isolation, and use of the APAAN.
Therefore, all chemical mixtures containing any quantity of APAAN would
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 proposes the modification of 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
If finalized as proposed, the designation of APAAN as a list I
chemical will subject APAAN 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, importing, and exporting
of a list I chemical. Upon publication of a final rule, persons
potentially handling APAAN, including regulated chemical mixtures
containing APAAN, would be
[[Page 89405]]
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. Consistent with 21 CFR parts 1309 and 1310, separate
registrations will be required for manufacturing, distribution,
importing, and exporting of APAAN. Different locations operated by a
single entity require separate registration if any location is involved
with the manufacture, distribution, importation, or exportation of
APAAN. Further, a separate registration is required for each principal
place of business at one general physical location where list I
chemicals are manufactured, distributed, imported, or exported by a
person. 21 CFR 1309.23. Any person manufacturing, distributing,
importing, or exporting an APAAN chemical mixture will be subject to
the registration requirement under the CSA as well.
The DEA notes that warehouses are exempt from the requirement of
registration and may lawfully possess list I chemicals, if the
possession of those chemicals is in the usual course of business or
employment. 21 U.S.C. 822(c)(2), 21 U.S.C. 957(b)(1)(B). For purposes
of this exemption, the warehouse must receive the list I chemical from
a DEA registrant and shall only distribute the list I chemical back to
the DEA registrant and registered location from which it was received.
All other activities conducted by a warehouse do not fall under this
exemption; a warehouse that distributes list I chemicals to persons
other than the registrant and registered location from which they were
obtained is conducting distribution activities and is required to
register as such. 21 CFR 1309.23(b)(1).
Upon publication of a 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 proposing to
establish 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 on or before 30 days after publication of a final rule
implementing regulations regarding APAAN. 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 the 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 would be required to
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 will be
required to 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 characteristics 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 would need to be 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 would be required to
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, would be unlawful, and may subject the person to
administrative, civil, and/or criminal action.
Regulatory Analyses
Executive Orders 12866 and 13563
This notice of proposed rulemaking, which proposes the designation
of APAAN as a list I chemical, has been developed in accordance with
the 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
[[Page 89406]]
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 to import 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 proposed rule would not have an
annual effect on the economy of $100 million or more and is not a
significant regulatory action.
Executive Order 12988
This proposed regulation 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 proposed rulemaking does not have federalism implications
warranting the application of Executive Order 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
This proposed 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 proposed
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 proposed 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 if the proposed rule is
finalized. 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
proposed 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 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 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 proposed to be
amended as follows:
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND 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) in the table ``List I chemicals'' to read as
follows:
Sec. 1310.02 Substances covered.
* * * * *
(a) * * *
------------------------------------------------------------------------
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(1) Alpha-phenylacetoacetonitrile and its salts, optical 8512
isomers, and salts of optical isomers (APAAN)..........
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* * * * *
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),
[[Page 89407]]
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 new 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 Section 1310.12 of
this part, 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 Section 1310.13 of
this part on or before (30 days after publication of a Final Rule
implementing regulations regarding APAAN). 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 paragraph (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
----------------------------------------------------------------------------------------------------------------
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.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: December 2, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-29523 Filed 12-9-16; 8:45 am]
BILLING CODE 4410-09-P