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[Federal Register: March 31, 2011 (Volume 76, Number 62)]
[Rules and Regulations]               
[Page 17778-17781]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr11-6]                         

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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
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