Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Proposed Rules 8287 

phone number). You may also submit 

comments through the Internet at 

http://www.regulations.gov. 

Commenters wishing the FAA to 

acknowledge receipt of their comments 

on this action must submit with those 

comments a self-addressed, stamped 

postcard on which the following 

statement is made: ‘‘Comments to FAA 

Docket No. FAA–2010–0028 and 

Airspace Docket No. 10–AWP–1.’’ The 

postcard will be date/time stamped and 

returned to the commenter. 

All communications received on or 

before the specified closing date for 

comments will be considered before 

taking action on the proposed rule. The 

proposal contained in this action may 

be changed in light of comments 

received. All comments submitted will 

be available for examination in the 

public docket both before and after the 

closing date for comments. A report 

summarizing each substantive public 

contact with FAA personnel concerned 

with this rulemaking will be filed in the 

docket. 

Availability of NPRMs 

An electronic copy of this document 

may be downloaded through the 

Internet at http://www.regulations.gov. 

Recently published rulemaking 

documents can also be accessed through 

the FAA’s Web page at http:// 

www.faa.gov/air_traffic/publications/ 

airspace_amendments/. 

You may review the public docket 

containing the proposal, any comments 

received, and any final disposition in 

person in the Dockets Office (see 

ADDRESSES section for address and 

phone number) between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. An informal docket 

may also be examined during normal 

business hours at the office of the 

Western Service Center, Operations 

Support Group, Federal Aviation 

Administration, 1601 Lind Avenue, 

SW., Renton, WA 98055. 

Persons interested in being placed on 

a mailing list for future NPRMs should 

contact the FAA’s Office of Rulemaking, 

(202) 267–9677, for a copy of Advisory 

Circular No. 11–2A, Notice of Proposed 

Rulemaking Distribution System, which 

describes the application procedure. 

The Proposal 

The FAA is proposing an amendment 

to Title 14 Code of Federal Regulations 

(14 CFR) part 71 to replace the DOBNE 

waypoint with the KENNO waypoint to 

provide additional lateral separation 

from the boundary of R–2508 and Q–15. 

The FAA has determined that this 

segment of Q–15 does not provide 

adequate separation from R–2508. The 

operational benefits of this change will 

positively impact the day-to-day traffic 

flow on Q–15 within the NAS. 

Area Navigation Routes are published 

in paragraph 2006 of FAA Order 

7400.9T, dated August 27, 2009 and 

effective September 15, 2009, which is 

incorporated by reference in 14 CFR 

71.1. The Area Navigation Route listed 

in this document would be 

subsequently published in the Order. 

The FAA has determined that this 

proposed regulation only involves an 

established body of technical 

regulations for which frequent and 

routine amendments are necessary to 

keep them operationally current. 

Therefore, this proposed regulation: (1) 

Is not a ‘‘significant regulatory action’’ 

under Executive Order 12866; (2) is not 

a ‘‘significant rule’’ under Department of 

Transportation (DOT) Regulatory 

Policies and Procedures (44 FR 11034; 

February 26, 1979); and (3) does not 

warrant preparation of a regulatory 

evaluation as the anticipated impact is 

so minimal. Since this is a routine 

matter that will only affect air traffic 

procedures and air navigation, it is 

certified that this proposed rule, when 

promulgated, will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the United States Code. 

Subtitle I, Section 106 describes the 

authority of the FAA Administrator. 

Subtitle VII, Aviation Programs, 

describes in more detail the scope of the 

agency’s authority. 

This rulemaking is promulgated 

under the authority described in 

Subtitle VII, Part A, Subpart I, Section 

40103. Under that section, the FAA is 

charged with prescribing regulations to 

assign the use of the airspace necessary 

to ensure the safety of aircraft and the 

efficient use of airspace. This regulation 

is within the scope of that authority as 

it modifies an RNAV route in California. 

Environmental Review 

This proposal will be subject to an 

environmental analysis in accordance 

with FAA Order 1050.1E, 

‘‘Environmental Impacts: Policies and 

Procedures,’’ prior to any FAA final 

regulatory action. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

The Proposed Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

proposes to amend 14 CFR part 71 as 

follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

1. The authority citation for part 71 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 

1963 Comp., p. 389. 

§ 71.1 [Amended] 

2. The incorporation by reference in 

14 CFR 71.1 of FAA Order 7400.9T, 

Airspace Designations and Reporting 

Points, dated August 27, 2009 and 

effective September 15, 2009, is 

amended as follows: 

Paragraph 2006 Area Navigation Routes 

* * * * * 

Q–15 LOMIA to CHILY 

LOMIA WP 

(Lat. 39°13′12′′ N., long. 119°06′23′′ W.) 

RUSME WP 

(Lat. 37°29′39′′ N., long. 117°31′12′′ W.) 

KENNO WP 

(Lat. 37°17′53′′ N., long. 117°18′37′′ W.) 

BIKKR WP 

(Lat. 36°34′00′′ N., long. 116°45′00′′ W.) 

DOVEE Fix 

(Lat. 35°26′51′′ N., long. 114°48′01′′ W.) 

CHILY Fix 

(Lat. 34°42′49′′ N., long. 112°45′42′′ W.) 

Issued in Washington, DC, February 17, 

2010. 

Paul Gallant, 

Acting Manager, Airspace and Rules Group. 

[FR Doc. 2010–3747 Filed 2–23–10; 8:45 am] 

BILLING CODE 4910–13–P 

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. 

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 


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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 

dea.diversion.policy@usdoj.gov. 

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 


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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 


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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 


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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 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 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: 

§ 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 


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8292 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Proposed Rules 

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

follows: 

§ 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: 

§ 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: 

§ 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 concentration.Chemical mixtures 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2010–0009; FRL–9115–8] 

Approval and Promulgation of Air 

Quality Implementation Plans; Virginia; 

Opacity Source Surveillance Methods 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA proposes to approve the 

State Implementation Plan (SIP) 

revision submitted by the 

Commonwealth of Virginia for the 

purpose of updating methods for 

determining compliance with opacity 

standards for existing, new and 

modified stationary sources in Virginia. 

In the Final Rules section of this 

Federal Register, EPA is approving the 

State’s SIP submittal as a direct final 

rule without prior proposal because the 

Agency views this as a noncontroversial 

submittal and anticipates no adverse 

comments. A detailed rationale for the 

approval is set forth in the direct final 

rule. If no adverse comments are 

received in response to this action, no 

further activity is contemplated. If EPA 

receives adverse comments, the direct 

final rule will be withdrawn and all 

public comments received will be 

addressed in a subsequent final rule 

based on this proposed rule. EPA will 

not institute a second comment period. 

Any parties interested in commenting 

on this action should do so at this time. 

DATES: Comments must be received in 

writing by March 26, 2010. 

ADDRESSES: Submit your comments, 

identified by Docket ID Number EPA– 

R03–OAR–2010–0009 by one of the 

following methods: 

A. http://www.regulations.gov. Follow 

the on-line instructions for submitting 

comments. 

B. E-mail: 

fernandez.cristina@epa.gov. 

C. Mail: EPA–R03–OAR–2010–0009, 

Cristina Fernandez, Associate Director, 

Office of Air Program Planning, 

Mailcode 3AP30, U.S. Environmental 

Protection Agency, Region III, 1650 

Arch Street, Philadelphia, Pennsylvania 

19103. 

D. Hand Delivery: At the previouslylisted EPA Region III address. Such 

deliveries are only accepted during the 

Docket’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. EPA–R03–OAR–2010– 

0009. EPA’s policy is that all comments 

received will be included in the public 

docket without change, and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 


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