Control of Ergocristine, a Chemical Precursor Used in the Illicit Manufacture of Lysergic Acid Diethylamide, as a List I Chemical, 17778-17781 [2011-7548]
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Federal Register / Vol. 76, No. 62 / Thursday, March 31, 2011 / Rules and Regulations
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
DEPARTMENT OF JUSTICE
7. The authority citation for 21 CFR
part 522 continues to read as follows:
21 CFR Part 1310
Drug Enforcement Administration
■
[Docket No. DEA–320F]
Authority: 21 U.S.C. 360b.
§ 522.1081
RIN 1117–AB24
Illicit Production of LSD
[Amended]
8. In paragraph (b)(2) of § 522.1081,
remove ‘‘Nos. 058639 and 063323’’ and
in its place add ‘‘No. 058639’’.
■
Control of Ergocristine, a Chemical
Precursor Used in the Illicit
Manufacture of Lysergic Acid
Diethylamide, as a List I Chemical
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Final rule.
AGENCY:
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
Authority: 21 U.S.C. 360b.
■
[Removed]
10. Remove § 524.520.
§ 524.1580c
[Amended]
11. In paragraph (b) of § 524.1580c,
remove ‘‘Nos. 000010, 000069, and
050749’’ and in its place add ‘‘Nos.
000010 and 000069’’.
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
12. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
§ 558.485
[Amended]
13. In § 558.485, in paragraph (b)(3),
remove ‘‘010439’’.
■
§ 558.625
[Amended]
14. In § 558.625, remove and reserve
paragraphs (b)(42) and (b)(45).
■
§ 558.630
[Amended]
15. In § 558.630, remove and reserve
paragraph (b)(4); and in paragraph
(b)(5), remove ‘‘010439,’’ and ‘‘016968,’’.
■
Dated: March 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–7560 Filed 3–30–11; 8:45 am]
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BILLING CODE 4160–01–P
This rulemaking finalizes a
February 24, 2010, Notice of Proposed
Rulemaking in which DEA proposed to
control the chemical precursor
ergocristine as a List I chemical under
the Controlled Substances Act (CSA).
Clandestine laboratories are using this
chemical as a substitute for the List I
chemicals ergotamine and ergonovine to
illicitly manufacture the schedule I
controlled substance lysergic acid
diethylamide (LSD).
This rule is being finalized as
proposed. Therefore, handlers of
ergocristine shall be subject to the
chemical regulatory provisions of the
CSA and its implementing regulations.
This rulemaking does not establish a
threshold for domestic and international
transactions of ergocristine. As such, all
transactions involving ergocristine,
regardless of size, shall be regulated.
This rulemaking also specifies that
chemical mixtures containing
ergocristine will not be exempt from
regulatory requirements at any
concentration. Therefore, all
transactions of chemical mixtures
containing any quantity of ergocristine
shall be regulated and subject to control
under the CSA.
DATES: This rulemaking becomes
effective May 2, 2011. Persons seeking
registration must apply on or before
May 2, 2011 to continue their business
pending final action by DEA on their
application.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, PhD, Chief, Drug
and Chemical Evaluation Section, Office
of Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152; telephone: (202)
307–7183.
SUPPLEMENTARY INFORMATION:
SUMMARY:
9. The authority citation for 21 CFR
part 524 continues to read as follows:
■
§ 524.520
Background
Lysergic acid diethylamide (LSD) is a
synthetic schedule I hallucinogen. It is
the most potent hallucinogen known
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and only microgram amounts are
required to produce overt
hallucinations. It induces a heightened
awareness of sensory input that is
accompanied by an enhanced sense of
clarity, but reduced ability to control
what is experienced.
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LSD has been manufactured illegally
since the 1960s. A limited number of
chemists, probably less than a dozen,
are believed to be manufacturing nearly
all of the LSD available in the United
States. Clandestine laboratory operators
must adhere to precise and complex
production procedures, and production
of LSD is relatively difficult.
LSD has historically been produced
from lysergic acid, which is made from
ergotamine or ergonovine, substances
derived from an ergot fungus on rye, or
from lysergic acid amide, a chemical
found in morning glory seeds.
Movement to Ergocristine as LSD
Precursor and Largest LSD Laboratory
Ever Seized by DEA
Because of the existing CSA
regulatory controls on the LSD
precursors lysergic acid, lysergic acid
amide, ergotamine, and ergonovine,
clandestine laboratory operators have
sought uncontrolled sources of
precursor material for the production of
LSD. This has led to the illicit
utilization of the precursor chemical
ergocristine as a direct substitute for
ergotamine and ergonovine for the illicit
production of LSD. In fact, the largest
clandestine LSD laboratory ever seized
by DEA utilized ergocristine as the LSD
precursor. Recipes documenting
procedures for utilizing ergocristine in
LSD synthesis are easily found on the
Internet.
Availability of the Precursor Chemical
DEA has determined that ergocristine
is readily available from commercial
chemical suppliers. DEA has identified
at least three suppliers of ergocristine, of
which one distributor is located
domestically; the other two are based in
Germany and the Czech Republic.
This rule implements both domestic
and import/export controls on
ergocristine (and its salts). As noted in
the February 24, 2010, Notice of
Proposed Rulemaking (75 FR 8287),
such controls are deemed necessary for
law enforcement to identify domestic
and international transactions in
ergocristine, due to growing concerns
regarding its use for the illicit
manufacture of LSD.
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Federal Register / Vol. 76, No. 62 / Thursday, March 31, 2011 / Rules and Regulations
Regulation of Ergocristine as a List I
Chemical
The CSA, specifically 21 U.S.C.
802(34), and its implementing
regulations at 21 CFR 1310.02(c),
provide the Attorney General with the
authority to specify, by regulation,
additional chemicals as List I
chemicals’’ if they are used in the
manufacture of a controlled substance
in violation of the CSA, and are
important to the manufacture of the
controlled substance. Ergocristine is
being used in clandestine laboratories as
the precursor material for the illicit
manufacture of the schedule I controlled
substance LSD. This rule implements
the regulation of ergocristine as a List I
chemical because DEA finds that it is
used in the illicit manufacture of the
controlled substance LSD and is
important to the illicit manufacture of
the controlled substance LSD.
Handlers of ergocristine shall be
subject to the chemical regulatory
provisions of the CSA, including 21 CFR
parts 1309, 1310, 1313, and 1316. This
rulemaking does not establish a
threshold for domestic and import
transactions of ergocristine pursuant to
the provisions of 21 CFR 1310.04(g).
Due to the high potency of LSD, even a
single gram (i.e., 1/28th of an ounce) of
ergocristine can be used illicitly to make
thousands of dosage units of LSD.
Therefore, all ergocristine transactions,
regardless of size, shall be regulated
transactions as defined in 21 CFR
1300.02(b)(28). As such, all ergocristine
transactions will be subject to
recordkeeping, annual manufacturer
reporting of inventory and use data,
import/export controls, and other CSA
chemical regulatory requirements.
Comments
DEA did not receive any comments in
response to the February 24, 2010,
Notice of Proposed Rulemaking
(NPRM), which proposed the control of
ergocristine. Therefore, this rule
finalizes the NPRM, as proposed.
As such, effective May 2, 2011,
handlers of ergocristine shall be subject
to the chemical regulatory provisions of
the CSA and its implementing
regulations, including 21 CFR parts
1309, 1310, 1313, and 1316.
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Chemical Mixtures Containing
Ergocristine
Chemical mixtures containing
ergocristine will not be exempt from
regulatory requirements at any
concentration, unless an application for
exemption of a chemical mixture is
submitted by an ergocristine
manufacturer and the application is
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reviewed and accepted by DEA under
21 CFR 1310.13 (Exemption by
Application Process). Since even a small
amount of ergocristine is able to be used
in the illicit manufacture of a significant
amount of LSD, the control of chemical
mixtures containing any amount of
ergocristine is necessary to prevent the
illicit extraction, isolation, and use of
the ergocristine. Therefore, all chemical
mixtures containing any quantity of
ergocristine will be subject to CSA
control, unless the ergocristine
manufacturer is granted an exemption
by the application process discussed
below. The Table of Concentration
Limits in 21 CFR 1310.12(c) is hereby
modified to reflect the fact that chemical
mixtures containing any amount of
ergocristine are subject to CSA chemical
control provisions.
Exemption by Application Process
DEA has implemented an application
process to exempt chemical mixtures
from the requirements of the CSA and
its implementing regulations (21 CFR
1310.13). Under the application process,
manufacturers may submit an
application for exemption for those
mixtures that do not qualify for
automatic exemption. Exemption status
can be granted if 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 cannot be
readily recovered (i.e., it meets the
conditions in 21 U.S.C. 802(39)(A)(vi)).
Requirements for Handling List I
Chemicals
The designation of ergocristine as a
List I chemical subjects ergocristine
handlers to all of the regulatory controls
and administrative, civil, and criminal
sanctions applicable to the manufacture,
distribution, importing, and exporting of
a List I chemical. Persons potentially
handling ergocristine, including
regulated chemical mixtures containing
ergocristine, will be required to comply
with the following List I chemical
regulations:
Registration. Any person who
manufactures, distributes, imports, or
exports a List I chemical, or proposes to
engage in the manufacture, distribution,
importation, or exportation of a List I
chemical, must obtain a registration
pursuant to the CSA (21 U.S.C. 822,
957). 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 ergocristine. Different
locations operated by a single entity
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require separate registration if any
location is involved with the
manufacture, distribution, importation,
or exportation of ergocristine. 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 ergocristine chemical
mixture will be subject to the
registration requirement under the CSA
as well.
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 (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)).
Any person manufacturing,
distributing, importing, or exporting
ergocristine or a chemical mixture
containing ergocristine will be subject to
the registration requirement under the
CSA. 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 DEA
to immediately issue registrations for
those activities. Therefore, to allow
continued legitimate commerce in
ergocristine, DEA is establishing in
21 CFR 1310.09, a temporary exemption
from the registration requirement for
persons desiring to engage in activities
with ergocristine, provided that DEA
receives a properly completed
application for registration on or before
May 2, 2011. The temporary exemption
for such persons will remain in effect
until 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 May 2, 2011.
Therefore, all transactions of
ergocristine and chemical mixtures
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Federal Register / Vol. 76, No. 62 / Thursday, March 31, 2011 / Rules and Regulations
containing ergocristine 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
ergocristine, nor does it supersede State
or local laws or regulations. All
handlers of ergocristine must comply
with applicable State and local
requirements in addition to the CSA
regulatory controls.
Records and Reports. The CSA
(21 U.S.C. 830) requires that certain
records be kept and reports be made
with respect to listed chemicals.
Regulations describing recordkeeping
and reporting requirements are set forth
in 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 readily
retrievable from the report.
Title 21 CFR 1310.05(a) requires that
each regulated person shall report to
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.
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.
Import/Export. All imports, exports,
and international transactions of a listed
chemical shall comply with the CSA
import and export provisions including
21 U.S.C. 957 and 971. Regulations for
importation and exportation of List I
chemicals are described in 21 CFR part
1313.
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Security. All applicants and
registrants shall provide effective
controls against theft and diversion of
chemicals as described in 21 CFR
1309.71.
Administrative Inspection. Places,
including factories, warehouses, or
other establishments and conveyances,
where registrants or other regulated
persons may lawfully hold,
manufacture, distribute, dispense,
administer, or otherwise dispose of a
regulated chemical/chemical mixture or
where records relating to those activities
are kept or required to be kept, are
controlled premises as defined in
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.
Regulatory Certifications
Regulatory Flexibility Act and Small
Business Concerns
The Administrator hereby certifies
that this rulemaking has been drafted in
accordance with the Regulatory
Flexibility Act (5 U.S.C. 601–612). DEA
has been able to identify only one U.S.
distributor that lists ergocristine among
its products. Because most of the firm’s
product source appears to be located
outside the U.S. and because DEA has
not been able to identify any U.S.
manufacturer that produces a product
containing ergocristine, DEA does not
consider it likely that this domestic
distributor would be subject to the rule,
unless they imported ergocristine. The
only probable legitimate commerce in
this chemical appears to be the use of
ergocristine as precursor material for the
synthesis of a research compound. If
used for this purpose, then there would
be a registration and recordkeeping
requirement for this distributor to
import the ergocristine. Such use would
likely be extremely limited. Therefore,
the Administrator certifies that this rule
will not have a significant economic
impact on a substantial number of small
entities.
Executive Order 12866
The Administrator certifies that this
rulemaking has been drafted in
accordance with the principles in
Executive Order 12866 Section 1(b). It
has been determined that this is ‘‘a
significant regulatory action.’’ Therefore,
this action has been reviewed by the
Office of Management and Budget. DEA
has not conducted an economic analysis
of the final rule because DEA has been
able to identify only one company with
a U.S. address that lists ergocristine
among its products. DEA was able to
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identify only two foreign firms that list
ergocristine as a product. These firms
appear to sell ergocristine as an active
pharmaceutical ingredient, but a search
of the Food and Drug Administration’s
database of approved drugs did not
identify any drug with ergocristine as an
active ingredient. Consequently, DEA
does not believe that at this time any
firm conducting legitimate business is
likely to have to comply with the rule.
Executive Order 12988
This regulation meets the applicable
standards set forth in Sections 3(a) and
3(b)(2) of Executive Order 12988, Civil
Justice Reform.
Executive Order 13132
This rulemaking does not preempt or
modify any provision of State law; nor
does it impose enforcement
responsibilities on any State; nor does it
diminish the power of any State to
enforce its own laws. Accordingly, this
rulemaking does not have federalism
implications warranting the application
of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the
expenditure by State, local, and Tribal
governments, in the aggregate, or by the
private sector, of $126,400,000 or more
(adjusted for inflation) in any one year,
and will not significantly or uniquely
affect small governments. Therefore, no
actions were deemed necessary under
the provisions of the Unfunded
Mandates Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as
defined by Section 804 of the
Congressional Review Act/Small
Business Regulatory Enforcement
Fairness Act of 1996 (Congressional
Review Act). This rule will not result in
an annual effect on the economy of
$100,000,000 or more; a major increase
in cost or prices; or significant adverse
effects on competition, employment,
investment, productivity, innovation, or
on the ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.
List of Subjects in 21 CFR Part 1310
Drug traffic control, Exports, Imports,
Reporting and recordkeeping
requirements.
For the reasons set out above, 21 CFR
part 1310 is amended as follows:
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17781
Federal Register / Vol. 76, No. 62 / Thursday, March 31, 2011 / Rules and Regulations
4. Section 1310.09 is amended by
adding new paragraph (l) to read as
follows:
PART 1310—RECORDS AND
REPORTS OF LISTED CHEMICALS
AND CERTAIN MACHINES
■
1. The authority citation for part 1310
continues to read as follows:
§ 1310.09 Temporary exemption from
registration.
■
*
Authority: 21 U.S.C. 802, 827(h), 830,
871(b), 890.
2. Section 1310.02 is amended by
adding a new paragraph (a)(30) to read
as follows:
■
§ 1310.02
Substances covered.
*
*
*
*
*
(a) * * *
(30) Ergocristine and its salts 8612
*
*
*
*
*
■ 3. Section 1310.04 is amended by
redesignating paragraphs (g)(1)(ii)
through (g)(1)(ix) as paragraphs
(g)(1)(iii) through (g)(1)(x), and adding a
new paragraph (g)(1)(ii) to read as
follows:
§ 1310.04
Maintenance of records.
*
*
*
*
*
(g) * * *
(1) * * *
(iii) Ergocristine and its salts
*
*
*
*
*
*
*
*
*
(l)(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 ergocristine
and its salts, including regulated
chemical mixtures pursuant to
§ 1310.12, is temporarily exempted from
the registration requirement, provided
that DEA receives a properly completed
application for registration or
application for exemption for a
chemical mixture containing
ergocristine and its salts pursuant to
§ 1310.13 on or before May 2, 2011. 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
ergocristine and its salts whose
application for exemption is
subsequently denied by DEA must
obtain a registration with DEA. A
temporary exemption from the
registration requirement will also be
provided for those persons whose
applications for exemption are denied,
provided that 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
DEA takes final action on their
registration application.
5. Section 1310.12 is amended by
adding in alphabetical order an entry
‘‘Ergocristine and its salts’’ in the table
‘‘Table of Concentration Limits’’ to read
as follows:
■
§ 1310.12
*
Exempt chemical mixtures.
*
*
(c) * * *
*
*
TABLE OF CONCENTRATION LIMITS
DEA chemical
code No.
Concentration
Special conditions
*
Not exempt at any concentration.
*
*
*
Chemical mixtures containing any amount of ergocristine
and its salts are not exempt.
List I Chemicals
*
*
Ergocristine and its salts ........
*
*
*
*
8612
*
*
*
*
*
ACTION:
Dated: March 21, 2011.
Michele M. Leonhart,
Administrator.
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9515]
RIN 1545–BH20
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Correcting amendment.
This document describes
correcting amends to final and
temporary regulations concerning the
treatment of certain intercompany gain
with respect to stock owned by
members of a consolidated group. These
regulations provide for the
redetermination of intercompany gain as
excluded from gross income in certain
transactions involving stock transfers
between members of a consolidated
group. These errors were made when
the agency published final and
temporary regulations (TD 9515) in the
Federal Register on Friday, March 4,
2011 (76 FR 11956).
BILLING CODE 4410–09–P
Guidance Under Section 1502;
Amendment of Matching Rule for
Certain Gains on Member Stock;
Correction
This correction is effective on
March 31, 2011, and is applicable on
March 4, 2011.
DATES:
Internal Revenue Service (IRS),
Treasury.
AGENCY:
13:25 Mar 30, 2011
*
SUMMARY:
[FR Doc. 2011–7548 Filed 3–30–11; 8:45 am]
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*
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John
F. Tarrant, (202) 622–7790 or Lawrence
FOR FURTHER INFORMATION CONTACT:
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*
*
M. Axelrod, (202) 622–7713 (not tollfree numbers).
SUPPLEMENTARY INFORMATION:
Background
The final and temporary regulations
(TD 9515) that are the subject of this
document are under section 1502 of the
Internal Revenue Code.
Need for Correction
As published, the final and temporary
regulations (TD 9515) contain errors that
may prove to be misleading and are in
need of clarification.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
Correction of Publication
Accordingly, 26 CFR part 1 is
corrected by making the following
correcting amendments:
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]]>Agencies
[Federal Register Volume 76, Number 62 (Thursday, March 31, 2011)]
[Rules and Regulations]
[Pages 17778-17781]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7548]
=======================================================================
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-320F]
RIN 1117-AB24
Control of Ergocristine, a Chemical Precursor Used in the Illicit
Manufacture of Lysergic Acid Diethylamide, as a List I Chemical
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This rulemaking finalizes a February 24, 2010, Notice of
Proposed Rulemaking in which DEA proposed to control the chemical
precursor ergocristine as a List I chemical under the Controlled
Substances Act (CSA). Clandestine laboratories are using this chemical
as a substitute for the List I chemicals ergotamine and ergonovine to
illicitly manufacture the schedule I controlled substance lysergic acid
diethylamide (LSD).
This rule is being finalized as proposed. Therefore, handlers of
ergocristine shall be subject to the chemical regulatory provisions of
the CSA and its implementing regulations. This rulemaking does not
establish a threshold for domestic and international transactions of
ergocristine. As such, all transactions involving ergocristine,
regardless of size, shall be regulated. This rulemaking also specifies
that chemical mixtures containing ergocristine will not be exempt from
regulatory requirements at any concentration. Therefore, all
transactions of chemical mixtures containing any quantity of
ergocristine shall be regulated and subject to control under the CSA.
DATES: This rulemaking becomes effective May 2, 2011. Persons seeking
registration must apply on or before May 2, 2011 to continue their
business pending final action by DEA on their application.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, 8701 Morrissette Drive, Springfield, VA
22152; telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION:
Background
Lysergic acid diethylamide (LSD) is a synthetic schedule I
hallucinogen. It is the most potent hallucinogen known and only
microgram amounts are required to produce overt hallucinations. It
induces a heightened awareness of sensory input that is accompanied by
an enhanced sense of clarity, but reduced ability to control what is
experienced.
Illicit Production of LSD
LSD has been manufactured illegally since the 1960s. A limited
number of chemists, probably less than a dozen, are believed to be
manufacturing nearly all of the LSD available in the United States.
Clandestine laboratory operators must adhere to precise and complex
production procedures, and production of LSD is relatively difficult.
LSD has historically been produced from lysergic acid, which is
made from ergotamine or ergonovine, substances derived from an ergot
fungus on rye, or from lysergic acid amide, a chemical found in morning
glory seeds.
Movement to Ergocristine as LSD Precursor and Largest LSD Laboratory
Ever Seized by DEA
Because of the existing CSA regulatory controls on the LSD
precursors lysergic acid, lysergic acid amide, ergotamine, and
ergonovine, clandestine laboratory operators have sought uncontrolled
sources of precursor material for the production of LSD. This has led
to the illicit utilization of the precursor chemical ergocristine as a
direct substitute for ergotamine and ergonovine for the illicit
production of LSD. In fact, the largest clandestine LSD laboratory ever
seized by DEA utilized ergocristine as the LSD precursor. Recipes
documenting procedures for utilizing ergocristine in LSD synthesis are
easily found on the Internet.
Availability of the Precursor Chemical
DEA has determined that ergocristine is readily available from
commercial chemical suppliers. DEA has identified at least three
suppliers of ergocristine, of which one distributor is located
domestically; the other two are based in Germany and the Czech
Republic.
This rule implements both domestic and import/export controls on
ergocristine (and its salts). As noted in the February 24, 2010, Notice
of Proposed Rulemaking (75 FR 8287), such controls are deemed necessary
for law enforcement to identify domestic and international transactions
in ergocristine, due to growing concerns regarding its use for the
illicit manufacture of LSD.
[[Page 17779]]
Regulation of Ergocristine as a List I Chemical
The CSA, specifically 21 U.S.C. 802(34), and its implementing
regulations at 21 CFR 1310.02(c), provide the Attorney General with the
authority to specify, by regulation, additional chemicals as List I
chemicals'' if they are used in the manufacture of a controlled
substance in violation of the CSA, and are important to the manufacture
of the controlled substance. Ergocristine is being used in clandestine
laboratories as the precursor material for the illicit manufacture of
the schedule I controlled substance LSD. This rule implements the
regulation of ergocristine as a List I chemical because DEA finds that
it is used in the illicit manufacture of the controlled substance LSD
and is important to the illicit manufacture of the controlled substance
LSD.
Handlers of ergocristine shall be subject to the chemical
regulatory provisions of the CSA, including 21 CFR parts 1309, 1310,
1313, and 1316. This rulemaking does not establish a threshold for
domestic and import transactions of ergocristine pursuant to the
provisions of 21 CFR 1310.04(g). Due to the high potency of LSD, even a
single gram (i.e., 1/28th of an ounce) of ergocristine can be used
illicitly to make thousands of dosage units of LSD. Therefore, all
ergocristine transactions, regardless of size, shall be regulated
transactions as defined in 21 CFR 1300.02(b)(28). As such, all
ergocristine transactions will be subject to recordkeeping, annual
manufacturer reporting of inventory and use data, import/export
controls, and other CSA chemical regulatory requirements.
Comments
DEA did not receive any comments in response to the February 24,
2010, Notice of Proposed Rulemaking (NPRM), which proposed the control
of ergocristine. Therefore, this rule finalizes the NPRM, as proposed.
As such, effective May 2, 2011, handlers of ergocristine shall be
subject to the chemical regulatory provisions of the CSA and its
implementing regulations, including 21 CFR parts 1309, 1310, 1313, and
1316.
Chemical Mixtures Containing Ergocristine
Chemical mixtures containing ergocristine will not be exempt from
regulatory requirements at any concentration, unless an application for
exemption of a chemical mixture is submitted by an ergocristine
manufacturer and the application is reviewed and accepted by DEA under
21 CFR 1310.13 (Exemption by Application Process). Since even a small
amount of ergocristine is able to be used in the illicit manufacture of
a significant amount of LSD, the control of chemical mixtures
containing any amount of ergocristine is necessary to prevent the
illicit extraction, isolation, and use of the ergocristine. Therefore,
all chemical mixtures containing any quantity of ergocristine will be
subject to CSA control, unless the ergocristine manufacturer is granted
an exemption by the application process discussed below. The Table of
Concentration Limits in 21 CFR 1310.12(c) is hereby modified to reflect
the fact that chemical mixtures containing any amount of ergocristine
are subject to CSA chemical control provisions.
Exemption by Application Process
DEA has implemented an application process to exempt chemical
mixtures from the requirements of the CSA and its implementing
regulations (21 CFR 1310.13). Under the application process,
manufacturers may submit an application for exemption for those
mixtures that do not qualify for automatic exemption. Exemption status
can be granted if 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 cannot be readily
recovered (i.e., it meets the conditions in 21 U.S.C. 802(39)(A)(vi)).
Requirements for Handling List I Chemicals
The designation of ergocristine as a List I chemical subjects
ergocristine handlers to all of the regulatory controls and
administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, importing, and exporting of a List I
chemical. Persons potentially handling ergocristine, including
regulated chemical mixtures containing ergocristine, will be required
to comply with the following List I chemical regulations:
Registration. Any person who manufactures, distributes, imports, or
exports a List I chemical, or proposes to engage in the manufacture,
distribution, importation, or exportation of a List I chemical, must
obtain a registration pursuant to the CSA (21 U.S.C. 822, 957).
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 ergocristine. Different
locations operated by a single entity require separate registration if
any location is involved with the manufacture, distribution,
importation, or exportation of ergocristine. 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
ergocristine chemical mixture will be subject to the registration
requirement under the CSA as well.
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 (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)).
Any person manufacturing, distributing, importing, or exporting
ergocristine or a chemical mixture containing ergocristine will be
subject to the registration requirement under the CSA. 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 DEA to immediately issue
registrations for those activities. Therefore, to allow continued
legitimate commerce in ergocristine, DEA is establishing in 21 CFR
1310.09, a temporary exemption from the registration requirement for
persons desiring to engage in activities with ergocristine, provided
that DEA receives a properly completed application for registration on
or before May 2, 2011. The temporary exemption for such persons will
remain in effect until 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 May 2, 2011.
Therefore, all transactions of ergocristine and chemical mixtures
[[Page 17780]]
containing ergocristine 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 ergocristine, nor does it supersede
State or local laws or regulations. All handlers of ergocristine must
comply with applicable State and local requirements in addition to the
CSA regulatory controls.
Records and Reports. The CSA (21 U.S.C. 830) requires that certain
records be kept and reports be made with respect to listed chemicals.
Regulations describing recordkeeping and reporting requirements are set
forth in 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 readily retrievable from the report.
Title 21 CFR 1310.05(a) requires that each regulated person shall
report to 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. 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.
Import/Export. All imports, exports, and international transactions
of a listed chemical shall comply with the CSA import and export
provisions including 21 U.S.C. 957 and 971. Regulations for importation
and exportation of List I chemicals are described in 21 CFR part 1313.
Security. All applicants and registrants shall provide effective
controls against theft and diversion of chemicals as described in 21
CFR 1309.71.
Administrative Inspection. Places, including factories, warehouses,
or other establishments and conveyances, where registrants or other
regulated persons may lawfully hold, manufacture, distribute, dispense,
administer, or otherwise dispose of a regulated chemical/chemical
mixture or where records relating to those activities are kept or
required to be kept, are controlled premises as defined in 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.
Regulatory Certifications
Regulatory Flexibility Act and Small Business Concerns
The Administrator hereby certifies that this rulemaking has been
drafted in accordance with the Regulatory Flexibility Act (5 U.S.C.
601-612). DEA has been able to identify only one U.S. distributor that
lists ergocristine among its products. Because most of the firm's
product source appears to be located outside the U.S. and because DEA
has not been able to identify any U.S. manufacturer that produces a
product containing ergocristine, DEA does not consider it likely that
this domestic distributor would be subject to the rule, unless they
imported ergocristine. The only probable legitimate commerce in this
chemical appears to be the use of ergocristine as precursor material
for the synthesis of a research compound. If used for this purpose,
then there would be a registration and recordkeeping requirement for
this distributor to import the ergocristine. Such use would likely be
extremely limited. Therefore, the Administrator certifies that this
rule will not have a significant economic impact on a substantial
number of small entities.
Executive Order 12866
The Administrator certifies that this rulemaking has been drafted
in accordance with the principles in Executive Order 12866 Section
1(b). It has been determined that this is ``a significant regulatory
action.'' Therefore, this action has been reviewed by the Office of
Management and Budget. DEA has not conducted an economic analysis of
the final rule because DEA has been able to identify only one company
with a U.S. address that lists ergocristine among its products. DEA was
able to identify only two foreign firms that list ergocristine as a
product. These firms appear to sell ergocristine as an active
pharmaceutical ingredient, but a search of the Food and Drug
Administration's database of approved drugs did not identify any drug
with ergocristine as an active ingredient. Consequently, DEA does not
believe that at this time any firm conducting legitimate business is
likely to have to comply with the rule.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice
Reform.
Executive Order 13132
This rulemaking does not preempt or modify any provision of State
law; nor does it impose enforcement responsibilities on any State; nor
does it diminish the power of any State to enforce its own laws.
Accordingly, this rulemaking does not have federalism implications
warranting the application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by State, local, and
Tribal governments, in the aggregate, or by the private sector, of
$126,400,000 or more (adjusted for inflation) in any one year, and will
not significantly or uniquely affect small governments. Therefore, no
actions were deemed necessary under the provisions of the Unfunded
Mandates Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as defined by Section 804 of the
Congressional Review Act/Small Business Regulatory Enforcement Fairness
Act of 1996 (Congressional Review Act). This rule will not result in an
annual effect on the economy of $100,000,000 or more; a major increase
in cost or prices; or significant adverse effects on competition,
employment, investment, productivity, innovation, or on the ability of
United States-based companies to compete with foreign-based companies
in domestic and export markets.
List of Subjects in 21 CFR Part 1310
Drug traffic control, Exports, Imports, Reporting and recordkeeping
requirements.
For the reasons set out above, 21 CFR part 1310 is amended as
follows:
[[Page 17781]]
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. Section 1310.02 is amended by adding a new paragraph (a)(30) to read
as follows:
Sec. 1310.02 Substances covered.
* * * * *
(a) * * *
(30) Ergocristine and its salts 8612
* * * * *
0
3. Section 1310.04 is amended by redesignating paragraphs (g)(1)(ii)
through (g)(1)(ix) as paragraphs (g)(1)(iii) through (g)(1)(x), and
adding a new paragraph (g)(1)(ii) to read as follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(g) * * *
(1) * * *
(iii) Ergocristine and its salts
* * * * *
0
4. Section 1310.09 is amended by adding new paragraph (l) to read as
follows:
Sec. 1310.09 Temporary exemption from registration.
* * * * *
(l)(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 ergocristine and its salts,
including regulated chemical mixtures pursuant to Sec. 1310.12, is
temporarily exempted from the registration requirement, provided that
DEA receives a properly completed application for registration or
application for exemption for a chemical mixture containing
ergocristine and its salts pursuant to Sec. 1310.13 on or before May
2, 2011. 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 ergocristine and its salts whose
application for exemption is subsequently denied by DEA must obtain a
registration with DEA. A temporary exemption from the registration
requirement will also be provided for those persons whose applications
for exemption are denied, provided that 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 DEA takes final action on their
registration application.
0
5. Section 1310.12 is amended by adding in alphabetical order an entry
``Ergocristine and its salts'' 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
----------------------------------------------------------------------------------------------------------------
List I Chemicals
* * * * * * *
Ergocristine and its salts........... 8612 Not exempt at any Chemical mixtures containing
concentration. any amount of ergocristine
and its salts are not
exempt.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: March 21, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-7548 Filed 3-30-11; 8:45 am]
BILLING CODE 4410-09-P
