[Federal Register Volume 76, Number 62 (Thursday, March 31, 2011)]
[Rules and Regulations]
[Pages 17778-17781]
From the Federal Register Online via the Government Publishing 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.
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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
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DEA chemical
code No. Concentration Special conditions
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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.
* * * * * * *
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* * * * *
Dated: March 21, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-7548 Filed 3-30-11; 8:45 am]
BILLING CODE 4410-09-P