[Federal Register Volume 75, Number 36 (Wednesday, February 24, 2010)]
[Proposed Rules]
[Pages 8287-8292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-3701]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[Docket No. DEA-320P]
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: Notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration (DEA) is proposing to 
control the chemical precursor ergocristine as a List I chemical under 
the Controlled Substances Act (CSA). Clandestine laboratories are using 
this

[[Page 8288]]

chemical as a substitute for the List I chemicals ergotamine and 
ergonovine to illicitly manufacture the schedule I controlled substance 
lysergic acid diethylamide (LSD).
    If finalized as proposed, handlers of ergocristine would be subject 
to the chemical regulatory provisions of the CSA and its implementing 
regulations, including 21 CFR parts 1309, 1310, 1313, and 1316. This 
rulemaking does not propose the establishment of a threshold for 
domestic and international transactions of ergocristine. As such, all 
transactions involving ergocristine, regardless of size, would be 
regulated. This rulemaking also proposes to specify 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 would be 
regulated and subject to control under the CSA if this rule is 
finalized as proposed.

DATES: Written comments must be postmarked and electronic comments must 
be submitted on or before April 26, 2010. Commenters should be aware 
that the electronic Federal Docket Management System will not accept 
comments after midnight Eastern Time on the last day of the comment 
period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-320P'' on all written and electronic correspondence. 
Written comments sent via regular or express mail should be sent to 
Drug Enforcement Administration, Attention: DEA Federal Register 
Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. 
Comments may be sent to DEA by sending an electronic message to 
<a href="/cdn-cgi/l/email-protection#b3d7d6d29dd7dac5d6c1c0dadcdd9dc3dcdfdad0caf3c6c0d7dcd99dd4dcc5"><span class="__cf_email__" data-cfemail="650100044b010c130017160c0a0b4b150a090c061c251016010a0f4b020a13">[email protected]</span></a>. Comments may also be sent 
electronically through http://www.regulations.gov using the electronic 
comment form provided on that site. An electronic copy of this document 
is also available at the http://www.regulations.gov Web site. DEA will 
accept attachments to electronic comments in Microsoft Word, 
WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept 
any file format other than those specifically listed here.
    Please note that DEA is requesting that electronic comments be 
submitted before midnight Eastern Time on the day the comment period 
closes because http://www.regulations.gov terminates the public's 
ability to submit comments at midnight Eastern time on the day the 
comment period closes. Commenters in time zones other than Eastern Time 
may want to consider this so that their electronic comments are 
received. All comments sent via regular or express mail will be 
considered timely if postmarked on the day the comment period closes.

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:
    Posting of Public Comments: Please note that all comments received 
are considered part of the public record and made available for public 
inspection online at http://www.regulations.gov and in the Drug 
Enforcement Administration's public docket. Such information includes 
personal identifying information (such as your name, address, etc.) 
voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted 
and the comment, in redacted form, will be posted online and placed in 
the Drug Enforcement Administration's public docket file. Please note 
that the Freedom of Information Act applies to all comments received. 
If you wish to inspect the agency's public docket file in person by 
appointment, please see the ``For Further Information'' paragraph.

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. LSD has 
been abused for its hallucinogenic properties since the 1960s. 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. The LSD ``trip'' is composed of perceptual and psychic 
effects. A user may experience the following perceptual effects: Visual 
distortion in the size and shape of objects, movements, color, sound, 
touch, and the user's own body image. The user may report ``hearing 
colors'' or ``seeing sounds.'' The psychic effects experienced by the 
user may include feelings of obtaining true insight, intensified 
emotions, sudden and dramatic mood swings, impairment of attention, 
concentration and motivation, distortion of time, and 
depersonalization.
    High doses of LSD can induce a ``bad trip'' characterized by 
intense anxiety or panic, confusion, and combative behaviors. After a 
LSD trip, a user may also experience fatigue, acute anxiety, or 
depression for 12 to 24 hours. LSD is commonly abused by teenagers and 
young adults in connection with ``raves,'' nightclubs, and concert 
settings.
    LSD is most commonly found in the form of small squares of paper, 
called blotter, that are generally decorated with artwork or designs, 
perforated, soaked in liquid LSD solution, and dried. Each square 
represents one dose of LSD. There have been some instances of blotter 
paper being found impregnated with hallucinogens other than LSD. For 
example, the hallucinogens 2,5-dimethoxyamphetamine (DMA) and 4-bromo-
2,5-dimethoxyamphetamine (DOB) have been found on blotter paper passed 
off as LSD.
    Other forms of LSD include tablets (known as microdots), gelatin 
squares (known as window pane), and impregnated sugar cubes. LSD has 
also been available in gel wraps which look like ``bubble-wrap'' 
packing material, and are blue in color. LSD is also distributed in 
liquid form which often is packaged in small bottles typically sold as 
breath drops. Additionally, LSD has been embedded in candy such as 
``Gummy Worms,'' ``Sweet Tarts,'' ``Smarties,'' and ``Pez.'' The most 
common venues for retail LSD

[[Page 8289]]

distribution are ``raves,'' dance clubs, and concerts.
    According to the National Forensic Laboratory Information System 
(NFLIS), Federal, State, and local forensic laboratories analyzed 1,785 
and 1,368 exhibits of LSD in 2000 and 2001, respectively. In 2002, the 
number of LSD exhibits dropped dramatically to 198 due to the seizure 
of a large clandestine LSD laboratory in Kansas. The number of LSD 
samples analyzed by Federal, State, and local forensic laboratories 
remained low for 2003 and 2004 with 362 and 338 LSD exhibits, 
respectively. However, there appears to be a slight increasing trend 
seen in 2005, 2006 and 2007, with 521, 590, and 844 exhibits reported, 
respectively. This trend appears to carry over into 2008 since NFLIS 
data, entered as of December 29, 2008 already documents 839 LSD 
exhibits.

Control Status

    Lysergic acid diethylamide is in schedule I of the CSA (21 U.S.C. 
812). LSD precursors, lysergic acid and lysergic acid amide, are both 
schedule III controlled substances (21 U.S.C. 812(b)). The LSD 
precursors ergotamine and ergonovine are regulated as List I chemicals 
under the CSA.

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. Although theoretically possible, manufacture of LSD from 
morning glory seeds is not economically feasible and these seeds never 
have been found to be a successful starting material for LSD 
production. The List I chemicals ergotamine and ergonovine are not 
widely available in the United States, and their purchase by other than 
established pharmaceutical firms is suspect. Therefore, ergotamine and/
or ergonovine used in clandestine LSD laboratories are believed to have 
been acquired from sources located abroad. Only a small amount of 
ergotamine or ergonovine is required to produce LSD in large batches. 
For example, 25 kilograms of ergotamine tartrate can produce five or 
six kilograms of pure LSD crystal that, under ideal circumstances, 
could be processed into 100 million dosage units. Thus, clandestine LSD 
manufacturers need import only a small quantity of precursor material.

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.
    In late 2000, in the largest clandestine LSD laboratory seizure 
ever made by the DEA, agents seized approximately 41.3 kilograms (90.86 
pounds) of LSD, manufactured in a clandestine laboratory set up in a 
missile silo near Wamego, Kansas. On November 6, 2000, two clandestine 
laboratory operators were moving the illegal laboratory when they were 
arrested. The clandestine laboratory operators utilized the chemical 
ergocristine as the unregulated source of precursor material for the 
production of the LSD. A total of 19 kilograms of ergocristine was 
seized. According to court testimony, the two defendants previously 
clandestinely manufactured LSD in Santa Fe, New Mexico, where every 
five weeks the clandestine laboratory produced about 2.2 pounds of LSD, 
approximately 10 million doses that cost less than one cent a dose to 
produce and would sell for as much as $10 a dose. According to court 
testimony, the LSD was shipped to California and later to Europe for 
distribution.
    The El Paso Intelligence Center's National Seizure System data show 
that five clandestine LSD laboratories have been seized since 2001. 
According to law enforcement reporting, the seized laboratories were 
operated by a small number of experienced chemists and were of limited 
capacity: three of which produced less than two ounces, and two of 
which produced between two and eight ounces per batch.

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. The ergocristine used by the clandestine laboratory operator 
arrested in conjunction with the November 2000, clandestine LSD 
laboratory in Wamego, Kansas, was obtained through a chemical supplier 
in Germany who obtained the ergocristine from a chemical source firm 
operating out of the Czech Republic.
    In the 2005 International Narcotics Control Board (INCB) report 
titled ``Precursors and Chemicals Frequently Used in the Illicit 
Manufacture of Narcotic Drugs and Psychotropic Substances,'' the INCB 
reported that in response to Czech authorities expression of concern 
over orders for ergocristine, INCB scrutiny over such shipments led to 
the one kilogram seizure of ergocristine by Panamanian authorities in 
early 2005. The INCB further reported that following the seizure, a 
further order was received from the Netherlands Antilles. The shipment 
of ergocristine was followed and a clandestine LSD laboratory 
identified. In that report, the INCB urged governments to exercise 
vigilance in regard to shipments of ergot alkaloids (such as 
ergocristine) and related substitutes not under international control.
    This rule proposes the addition of both domestic and import/export 
controls on ergocristine (and its salts). 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.

Regulation of Ergocristine as a List I Chemical

    The CSA, specifically 21 U.S.C. 802(34) and 21 U.S.C. 802(35), and 
its implementing regulations at 21 CFR 1310.02(c), provide the Attorney 
General with the authority to specify, by regulation, additional 
chemicals as ``listed 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 
proposes the regulation of ergocristine as a List I

[[Page 8290]]

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.
    If finalized as proposed, handlers of ergocristine will become 
subject to the chemical regulatory provisions of the CSA, including 21 
CFR parts 1309, 1310, 1313, and 1316. This rulemaking does not propose 
the establishment of 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, DEA is proposing that all ergocristine transactions, 
regardless of size, shall be regulated transactions as defined in 21 
CFR 1300.02(b)(28). As such, if finalized as proposed, 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.

Chemical Mixtures Containing Ergocristine

    This rulemaking also proposes that chemical mixtures containing 
ergocristine 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 make 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, if this rule is 
finalized as proposed, unless the ergocristine manufacturer is granted 
an exemption by the application process discussed below. If finalized, 
this proposed rule will modify the Table of Concentration Limits in 21 
CFR 1310.12(c) 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

    If finalized as proposed, the designation of ergocristine as a List 
I chemical will subject 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. Upon publication of a final rule, 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)).
    Upon publication of a final rule, any person manufacturing, 
distributing, importing, or exporting ergocristine or a chemical 
mixture containing ergocristine will become 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 
proposing to establish 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 30 days after publication of 
a Final Rule implementing regulations regarding ergocristine. 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 on the effective 
date of the Final Rule. Therefore, all transactions of ergocristine and 
chemical mixtures 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

[[Page 8291]]

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 1316 
Subpart A.

Regulatory Certifications

Regulatory Flexibility Act and Small Business Concerns

    The Deputy 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 Deputy Administrator 
certifies that this rule will not have a significant economic impact on 
a substantial number of small entities.

Executive Order 12866

    The Deputy 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 proposed 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 
$120,000,000 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 proposed to be 
amended 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:

    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:


Sec.  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)(vii) as paragraphs (g)(1)(iii) through 
(g)(1)(viii), and adding

[[Page 8292]]

a new paragraph (g)(1)(ii) to read as follows:


Sec.  1310.04  Maintenance of records.

* * * * *
    (g) * * *
    (1) * * *
    (ii) Ergocristine and its salts
* * * * *
    4. Section 1310.09 is amended by adding new paragraph (k) to read 
as follows:


Sec.  1310.09  Temporary exemption from registration.

* * * * *
    (k)(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 Section 1310.12 of 
this part, 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 Section 1310.13 of 
this part on or before (30 days after publication of a Final Rule 
implementing regulations regarding ergocristine). 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(c) 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 number          Concentration            Special conditions
----------------------------------------------------------------------------------------------------------------
                                                List I Chemicals
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Ergocristine and its salts..............            8612  Not exempt at any           Chemical mixtures
                                                           concentration.              containing any amount of
                                                                                       ergocristine and its
                                                                                       salts are not exempt.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: February 12, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-3701 Filed 2-23-10; 8:45 am]
BILLING CODE 4410-09-P


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