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

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

phone number). You may also submit operational benefits of this change will proposes to amend 14 CFR part 71 as comments through the Internet at positively impact the day-to-day traffic follows: http://www.regulations.gov. flow on Q–15 within the NAS. Commenters wishing the FAA to Area Navigation Routes are published PART 71—DESIGNATION OF CLASS A, acknowledge receipt of their comments in paragraph 2006 of FAA Order B, C, D, AND E AIRSPACE AREAS; AIR on this action must submit with those 7400.9T, dated August 27, 2009 and TRAFFIC SERVICE ROUTES; AND comments a self-addressed, stamped effective September 15, 2009, which is REPORTING POINTS postcard on which the following incorporated by reference in 14 CFR 1. The authority citation for part 71 statement is made: ‘‘Comments to FAA 71.1. The Area Navigation Route listed continues to read as follows: Docket No. FAA–2010–0028 and in this document would be Airspace Docket No. 10–AWP–1.’’ The subsequently published in the Order. Authority: 49 U.S.C. 106(g), 40103, 40113, postcard will be date/time stamped and 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– The FAA has determined that this 1963 Comp., p. 389. returned to the commenter. proposed regulation only involves an All communications received on or established body of technical § 71.1 [Amended] before the specified closing date for regulations for which frequent and 2. The incorporation by reference in comments will be considered before routine amendments are necessary to 14 CFR 71.1 of FAA Order 7400.9T, taking action on the proposed rule. The keep them operationally current. Airspace Designations and Reporting proposal contained in this action may Therefore, this proposed regulation: (1) Points, dated August 27, 2009 and be changed in light of comments Is not a ‘‘significant regulatory action’’ effective September 15, 2009, is received. All comments submitted will under Executive Order 12866; (2) is not amended as follows: be available for examination in the a ‘‘significant rule’’ under Department of public docket both before and after the Transportation (DOT) Regulatory Paragraph 2006 Area Navigation Routes closing date for comments. A report Policies and Procedures (44 FR 11034; * * * * * summarizing each substantive public February 26, 1979); and (3) does not Q–15 LOMIA to CHILY contact with FAA personnel concerned warrant preparation of a regulatory with this rulemaking will be filed in the LOMIA WP evaluation as the anticipated impact is ° ′ ″ ° ′ ″ docket. (Lat. 39 13 12 N., long. 119 06 23 W.) so minimal. Since this is a routine RUSME WP Availability of NPRMs matter that will only affect air traffic (Lat. 37°29′39″ N., long. 117°31′12″ W.) An electronic copy of this document procedures and air navigation, it is KENNO WP (Lat. 37°17′53″ N., long. 117°18′37″ W.) may be downloaded through the certified that this proposed rule, when promulgated, will not have a significant BIKKR WP Internet at http://www.regulations.gov. (Lat. 36°34′00″ N., long. 116°45′00″ W.) Recently published rulemaking economic impact on a substantial number of small entities under the DOVEE Fix documents can also be accessed through (Lat. 35°26′51″ N., long. 114°48′01″ W.) the FAA’s Web page at http:// criteria of the Regulatory Flexibility Act. CHILY Fix www.faa.gov/air_traffic/publications/ The FAA’s authority to issue rules (Lat. 34°42′49″ N., long. 112°45′42″ W.) regarding aviation safety is found in airspace_amendments/. Issued in Washington, DC, February 17, You may review the public docket Title 49 of the United States Code. 2010. Subtitle I, Section 106 describes the containing the proposal, any comments Paul Gallant, authority of the FAA Administrator. received, and any final disposition in Acting Manager, Airspace and Rules Group. person in the Dockets Office (see Subtitle VII, Aviation Programs, [FR Doc. 2010–3747 Filed 2–23–10; 8:45 am] ADDRESSES section for address and describes in more detail the scope of the phone number) between 9 a.m. and 5 agency’s authority. BILLING CODE 4910–13–P p.m., Monday through Friday, except This rulemaking is promulgated Federal holidays. An informal docket under the authority described in may also be examined during normal Subtitle VII, Part A, Subpart I, Section DEPARTMENT OF JUSTICE 40103. Under that section, the FAA is business hours at the office of the Drug Enforcement Administration Western Service Center, Operations charged with prescribing regulations to assign the use of the airspace necessary Support Group, Federal Aviation 21 CFR Part 1310 Administration, 1601 Lind Avenue, to ensure the safety of aircraft and the SW., Renton, WA 98055. efficient use of airspace. This regulation [Docket No. DEA–320P] Persons interested in being placed on is within the scope of that authority as RIN 1117–AB24 a mailing list for future NPRMs should it modifies an RNAV route in California. contact the FAA’s Office of Rulemaking, Environmental Review Control of Ergocristine, a Chemical (202) 267–9677, for a copy of Advisory Precursor Used in the Illicit Circular No. 11–2A, Notice of Proposed This proposal will be subject to an Manufacture of Lysergic Acid Rulemaking Distribution System, which environmental analysis in accordance Diethylamide, as a List I Chemical describes the application procedure. with FAA Order 1050.1E, ‘‘Environmental Impacts: Policies and AGENCY: Drug Enforcement The Proposal Procedures,’’ prior to any FAA final Administration (DEA), Department of The FAA is proposing an amendment regulatory action. Justice. to Title 14 Code of Federal Regulations ACTION: Notice of proposed rulemaking. (14 CFR) part 71 to replace the DOBNE List of Subjects in 14 CFR Part 71 waypoint with the KENNO waypoint to Airspace, Incorporation by reference, SUMMARY: The Drug Enforcement provide additional lateral separation Navigation (air). Administration (DEA) is proposing to from the boundary of R–2508 and Q–15. control the chemical precursor The Proposed Amendment The FAA has determined that this ergocristine as a List I chemical under segment of Q–15 does not provide In consideration of the foregoing, the the Controlled Substances Act (CSA). adequate separation from R–2508. The Federal Aviation Administration Clandestine laboratories are using this

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chemical as a substitute for the List I time zones other than Eastern Time may appointment, please see the ‘‘For chemicals ergotamine and ergonovine to want to consider this so that their Further Information’’ paragraph. illicitly manufacture the schedule I electronic comments are received. All Background controlled substance lysergic acid comments sent via regular or express diethylamide (LSD). mail will be considered timely if Lysergic acid diethylamide (LSD) is a If finalized as proposed, handlers of postmarked on the day the comment synthetic schedule I hallucinogen. It is ergocristine would be subject to the period closes. the most potent hallucinogen known chemical regulatory provisions of the FOR FURTHER INFORMATION CONTACT: and only microgram amounts are CSA and its implementing regulations, Christine A. Sannerud, PhD, Chief, Drug required to produce overt including 21 CFR parts 1309, 1310, and Chemical Evaluation Section, Office hallucinations. LSD has been abused for 1313, and 1316. This rulemaking does of Diversion Control, Drug Enforcement its hallucinogenic properties since the not propose the establishment of a Administration, 8701 Morrissette Drive, 1960s. It induces a heightened threshold for domestic and international Springfield, VA 22152; telephone: (202) awareness of sensory input that is transactions of ergocristine. As such, all 307–7183. accompanied by an enhanced sense of transactions involving ergocristine, clarity, but reduced ability to control regardless of size, would be regulated. SUPPLEMENTARY INFORMATION: what is experienced. The LSD ‘‘trip’’ is This rulemaking also proposes to Posting of Public Comments: Please composed of perceptual and psychic specify that chemical mixtures note that all comments received are effects. A user may experience the containing ergocristine will not be considered part of the public record and following perceptual effects: Visual exempt from regulatory requirements at made available for public inspection distortion in the size and shape of any concentration. Therefore, all online at http://www.regulations.gov objects, movements, color, sound, transactions of chemical mixtures and in the Drug Enforcement touch, and the user’s own body image. containing any quantity of ergocristine Administration’s public docket. Such The user may report ‘‘hearing colors’’ or would be regulated and subject to information includes personal ‘‘seeing sounds.’’ The psychic effects control under the CSA if this rule is identifying information (such as your experienced by the user may include finalized as proposed. name, address, etc.) voluntarily feelings of obtaining true insight, DATES: Written comments must be submitted by the commenter. intensified emotions, sudden and postmarked and electronic comments If you want to submit personal dramatic mood swings, impairment of must be submitted on or before April 26, identifying information (such as your attention, concentration and motivation, 2010. Commenters should be aware that name, address, etc.) as part of your distortion of time, and the electronic Federal Docket comment, but do not want it to be depersonalization. Management System will not accept posted online or made available in the High doses of LSD can induce a ‘‘bad comments after midnight Eastern Time public docket, you must include the trip’’ characterized by intense anxiety or on the last day of the comment period. phrase ‘‘PERSONAL IDENTIFYING panic, confusion, and combative ADDRESSES: To ensure proper handling INFORMATION’’ in the first paragraph behaviors. After a LSD trip, a user may of comments, please reference ‘‘Docket of your comment. You must also place also experience fatigue, acute anxiety, or No. DEA–320P’’ on all written and all the personal identifying information depression for 12 to 24 hours. LSD is electronic correspondence. Written you do not want posted online or made commonly abused by teenagers and comments sent via regular or express available in the public docket in the first young adults in connection with mail should be sent to Drug paragraph of your comment and identify ‘‘raves,’’ nightclubs, and concert settings. Enforcement Administration, Attention: what information you want redacted. LSD is most commonly found in the DEA Federal Register Representative/ If you want to submit confidential form of small squares of paper, called ODL, 8701 Morrissette Drive, business information as part of your blotter, that are generally decorated with Springfield, VA 22152. Comments may comment, but do not want it to be artwork or designs, perforated, soaked be sent to DEA by sending an electronic posted online or made available in the in liquid LSD solution, and dried. Each message to public docket, you must include the square represents one dose of LSD. [email protected]. phrase ‘‘CONFIDENTIAL BUSINESS There have been some instances of Comments may also be sent INFORMATION’’ in the first paragraph blotter paper being found impregnated electronically through http:// of your comment. You must also with hallucinogens other than LSD. For www.regulations.gov using the prominently identify confidential example, the hallucinogens 2,5- electronic comment form provided on business information to be redacted dimethoxyamphetamine (DMA) and that site. An electronic copy of this within the comment. If a comment has 4-bromo-2,5-dimethoxyamphetamine document is also available at the so much confidential business (DOB) have been found on blotter paper http://www.regulations.gov Web site. information that it cannot be effectively passed off as LSD. DEA will accept attachments to redacted, all or part of that comment Other forms of LSD include tablets electronic comments in Microsoft Word, may not be posted online or made (known as microdots), gelatin squares WordPerfect, Adobe PDF, or Excel file available in the public docket. (known as window pane), and formats only. DEA will not accept any Personal identifying information and impregnated sugar cubes. LSD has also file format other than those specifically confidential business information been available in gel wraps which look listed here. identified and located as set forth above like ‘‘bubble-wrap’’ packing material, Please note that DEA is requesting will be redacted and the comment, in and are blue in color. LSD is also that electronic comments be submitted redacted form, will be posted online and distributed in liquid form which often is before midnight Eastern Time on the placed in the Drug Enforcement packaged in small bottles typically sold day the comment period closes because Administration’s public docket file. as breath drops. Additionally, LSD has http://www.regulations.gov terminates Please note that the Freedom of been embedded in candy such as the public’s ability to submit comments Information Act applies to all comments ‘‘Gummy Worms,’’ ‘‘Sweet Tarts,’’ at midnight Eastern time on the day the received. If you wish to inspect the ‘‘Smarties,’’ and ‘‘Pez.’’ The most comment period closes. Commenters in agency’s public docket file in person by common venues for retail LSD

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distribution are ‘‘raves,’’ dance clubs, LSD crystal that, under ideal Availability of the Precursor Chemical and concerts. circumstances, could be processed into DEA has determined that ergocristine According to the National Forensic 100 million dosage units. Thus, is readily available from commercial Laboratory Information System (NFLIS), clandestine LSD manufacturers need chemical suppliers. DEA has identified Federal, State, and local forensic import only a small quantity of at least three suppliers of ergocristine, of laboratories analyzed 1,785 and 1,368 precursor material. which one distributor is located exhibits of LSD in 2000 and 2001, domestically; the other two are based in respectively. In 2002, the number of Movement to Ergocristine as LSD Germany and the Czech Republic. The LSD exhibits dropped dramatically to Precursor and Largest LSD Laboratory ergocristine used by the clandestine 198 due to the seizure of a large Ever Seized by DEA laboratory operator arrested in clandestine LSD laboratory in Kansas. conjunction with the November 2000, The number of LSD samples analyzed Because of the existing CSA by Federal, State, and local forensic regulatory controls on the LSD clandestine LSD laboratory in Wamego, laboratories remained low for 2003 and precursors lysergic acid, lysergic acid Kansas, was obtained through a 2004 with 362 and 338 LSD exhibits, amide, ergotamine, and ergonovine, chemical supplier in Germany who respectively. However, there appears to clandestine laboratory operators have obtained the ergocristine from a be a slight increasing trend seen in sought uncontrolled sources of chemical source firm operating out of 2005, 2006 and 2007, with 521, 590, and precursor material for the production of the Czech Republic. 844 exhibits reported, respectively. This LSD. This has led to the illicit In the 2005 International Narcotics trend appears to carry over into 2008 utilization of the precursor chemical Control Board (INCB) report titled since NFLIS data, entered as of ergocristine as a direct substitute for ‘‘Precursors and Chemicals Frequently December 29, 2008 already documents ergotamine and ergonovine for the illicit Used in the Illicit Manufacture of 839 LSD exhibits. production of LSD. In fact, the largest Narcotic Drugs and Psychotropic clandestine LSD laboratory ever seized Substances,’’ the INCB reported that in Control Status by DEA utilized ergocristine as the LSD response to Czech authorities Lysergic acid diethylamide is in precursor. Recipes documenting expression of concern over orders for ergocristine, INCB scrutiny over such schedule I of the CSA (21 U.S.C. 812). procedures for utilizing ergocristine in shipments led to the one kilogram LSD precursors, lysergic acid and LSD synthesis are easily found on the seizure of ergocristine by Panamanian lysergic acid amide, are both schedule Internet. III controlled substances (21 U.S.C. authorities in early 2005. The INCB 812(b)). The LSD precursors ergotamine In late 2000, in the largest clandestine further reported that following the and ergonovine are regulated as List I LSD laboratory seizure ever made by the seizure, a further order was received chemicals under the CSA. DEA, agents seized approximately 41.3 from the Netherlands Antilles. The kilograms (90.86 pounds) of LSD, shipment of ergocristine was followed Illicit Production of LSD manufactured in a clandestine and a clandestine LSD laboratory LSD has been manufactured illegally laboratory set up in a missile silo near identified. In that report, the INCB since the 1960s. A limited number of Wamego, Kansas. On November 6, 2000, urged governments to exercise vigilance chemists, probably less than a dozen, two clandestine laboratory operators in regard to shipments of ergot alkaloids are believed to be manufacturing nearly were moving the illegal laboratory when (such as ergocristine) and related all of the LSD available in the United they were arrested. The clandestine substitutes not under international States. Clandestine laboratory operators laboratory operators utilized the control. must adhere to precise and complex chemical ergocristine as the unregulated This rule proposes the addition of production procedures, and production source of precursor material for the both domestic and import/export of LSD is relatively difficult. production of the LSD. A total of 19 controls on ergocristine (and its salts). LSD has historically been produced kilograms of ergocristine was seized. Such controls are deemed necessary for from lysergic acid, which is made from According to court testimony, the two law enforcement to identify domestic ergotamine or ergonovine, substances defendants previously clandestinely and international transactions in derived from an ergot fungus on rye, or manufactured LSD in Santa Fe, New ergocristine, due to growing concerns from lysergic acid amide, a chemical Mexico, where every five weeks the regarding its use for the illicit found in morning glory seeds. Although clandestine laboratory produced about manufacture of LSD. theoretically possible, manufacture of 2.2 pounds of LSD, approximately 10 LSD from morning glory seeds is not Regulation of Ergocristine as a List I million doses that cost less than one Chemical economically feasible and these seeds cent a dose to produce and would sell never have been found to be a for as much as $10 a dose. According to The CSA, specifically 21 U.S.C. successful starting material for LSD court testimony, the LSD was shipped to 802(34) and 21 U.S.C. 802(35), and its production. The List I chemicals implementing regulations at 21 CFR California and later to Europe for ergotamine and ergonovine are not 1310.02(c), provide the Attorney distribution. widely available in the United States, General with the authority to specify, by and their purchase by other than The El Paso Intelligence Center’s regulation, additional chemicals as established pharmaceutical firms is National Seizure System data show that ‘‘listed chemicals’’ if they are used in the suspect. Therefore, ergotamine and/or five clandestine LSD laboratories have manufacture of a controlled substance ergonovine used in clandestine LSD been seized since 2001. According to in violation of the CSA, and are laboratories are believed to have been law enforcement reporting, the seized important to the manufacture of the acquired from sources located abroad. laboratories were operated by a small controlled substance. Ergocristine is Only a small amount of ergotamine or number of experienced chemists and being used in clandestine laboratories as ergonovine is required to produce LSD were of limited capacity: three of which the precursor material for the illicit in large batches. For example, 25 produced less than two ounces, and two manufacture of the schedule I controlled kilograms of ergotamine tartrate can of which produced between two and substance LSD. This rule proposes the produce five or six kilograms of pure eight ounces per batch. regulation of ergocristine as a List I

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chemical because DEA finds that it is application for exemption for those which it was received. All other used in the illicit manufacture of the mixtures that do not qualify for activities conducted by a warehouse do controlled substance LSD and is automatic exemption. Exemption status not fall under this exemption; a important to the illicit manufacture of can be granted if DEA determines that warehouse that distributes List I the controlled substance LSD. the mixture is formulated in such a way chemicals to persons other than the If finalized as proposed, handlers of that it cannot be easily used in the illicit registrant and registered location from ergocristine will become subject to the production of a controlled substance which they were obtained is conducting chemical regulatory provisions of the and that the listed chemical cannot be distribution activities and is required to CSA, including 21 CFR parts 1309, readily recovered (i.e., it meets the register as such (21 CFR 1309.23(b)(1)). 1310, 1313, and 1316. This rulemaking conditions in 21 U.S.C. 802(39)(A)(vi)). Upon publication of a final rule, any does not propose the establishment of a person manufacturing, distributing, threshold for domestic and import Requirements for Handling List I importing, or exporting ergocristine or a transactions of ergocristine pursuant to Chemicals chemical mixture containing the provisions of 21 CFR 1310.04(g). If finalized as proposed, the ergocristine will become subject to the Due to the high potency of LSD, even a designation of ergocristine as a List I registration requirement under the CSA. single gram (i.e., 1/28th of an ounce) of chemical will subject ergocristine DEA recognizes, however, that it is not ergocristine can be used illicitly to make handlers to all of the regulatory controls possible for persons who are subject to thousands of dosage units of LSD. and administrative, civil, and criminal the registration requirement to Therefore, DEA is proposing that all sanctions applicable to the manufacture, immediately complete and submit an ergocristine transactions, regardless of distribution, importing, and exporting of application for registration and for DEA size, shall be regulated transactions as a List I chemical. Upon publication of to immediately issue registrations for defined in 21 CFR 1300.02(b)(28). As a final rule, persons potentially those activities. Therefore, to allow such, if finalized as proposed, all handling ergocristine, including continued legitimate commerce in ergocristine transactions will be subject regulated chemical mixtures containing ergocristine, DEA is proposing to to recordkeeping, annual manufacturer ergocristine, will be required to comply establish in 21 CFR 1310.09 a temporary reporting of inventory and use data, with the following List I chemical exemption from the registration import/export controls, and other CSA regulations: requirement for persons desiring to chemical regulatory requirements. Registration. Any person who engage in activities with ergocristine, manufactures, distributes, imports, or provided that DEA receives a properly Chemical Mixtures Containing exports a List I chemical, or proposes to completed application for registration Ergocristine engage in the manufacture, distribution, on or before 30 days after publication of This rulemaking also proposes that importation, or exportation of a List I a Final Rule implementing regulations chemical mixtures containing chemical, must obtain a registration regarding ergocristine. The temporary ergocristine not be exempt from pursuant to the CSA (21 U.S.C. 822, exemption for such persons will remain regulatory requirements at any 957). Regulations describing registration in effect until DEA takes final action on concentration, unless an application for for List I chemical handlers are set forth their application for registration or exemption of a chemical mixture is in 21 CFR part 1309. Consistent with 21 application for exemption of a chemical submitted by an ergocristine CFR parts 1309 and 1310, separate mixture. manufacturer and the application is registrations will be required for The temporary exemption applies reviewed and accepted by DEA under manufacturing, distribution, importing, solely to the registration requirement; 21 CFR 1310.13 (Exemption by and exporting of ergocristine. Different all other chemical control requirements, Application Process). Since even a small locations operated by a single entity including recordkeeping and reporting, amount of ergocristine is able to make require separate registration if any would become effective on the effective a significant amount of LSD, the control location is involved with the date of the Final Rule. Therefore, all of chemical mixtures containing any manufacture, distribution, importation, transactions of ergocristine and amount of ergocristine is necessary to or exportation of ergocristine. Further, a chemical mixtures containing prevent the illicit extraction, isolation, separate registration is required for each ergocristine will be regulated while an and use of the ergocristine. Therefore, principal place of business at one application for registration or exemption all chemical mixtures containing any general physical location where List I is pending. This is necessary because quantity of ergocristine will be subject chemicals are manufactured, not regulating these transactions could to CSA control, if this rule is finalized distributed, imported, or exported by a result in increased diversion of as proposed, unless the ergocristine person (21 CFR 1309.23). Any person chemicals desirable to drug traffickers. manufacturer is granted an exemption manufacturing, distributing, importing, Additionally, the temporary by the application process discussed or exporting an ergocristine chemical exemption does not suspend applicable below. If finalized, this proposed rule mixture will be subject to the federal criminal laws relating to will modify the Table of Concentration registration requirement under the CSA ergocristine, nor does it supersede State Limits in 21 CFR 1310.12(c) to reflect as well. or local laws or regulations. All the fact that chemical mixtures DEA notes that warehouses are handlers of ergocristine must comply containing any amount of ergocristine exempt from the requirement of with applicable State and local are subject to CSA chemical control registration and may lawfully possess requirements in addition to the CSA provisions. List I chemicals, if the possession of regulatory controls. those chemicals is in the usual course Records and Reports. The CSA (21 Exemption by Application Process of business (21 U.S.C. 822(c)(2), 21 U.S.C. 830) requires that certain records DEA has implemented an application U.S.C. 957(b)(1)(B)). For purposes of this be kept and reports be made with process to exempt chemical mixtures exemption, the warehouse must receive respect to listed chemicals. Regulations from the requirements of the CSA and the List I chemical from a DEA describing recordkeeping and reporting its implementing regulations (21 CFR registrant and shall only distribute the requirements are set forth in 21 CFR 1310.13). Under the application process, List I chemical back to the DEA part 1310. Pursuant to 21 CFR 1310.04, manufacturers may submit an registrant and registered location from a record must be made and maintained

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for two years after the date of a Regulatory Certifications Executive Order 13132 transaction involving a listed chemical, Regulatory Flexibility Act and Small This rulemaking does not preempt or provided the transaction is a regulated Business Concerns modify any provision of state law; nor transaction. does it impose enforcement Each regulated bulk manufacturer of a The Deputy Administrator hereby responsibilities on any state; nor does it listed chemical will be required to certifies that this rulemaking has been diminish the power of any state to submit manufacturing, inventory, and drafted in accordance with the enforce its own laws. Accordingly, this use data on an annual basis (21 CFR Regulatory Flexibility Act (5 U.S.C. rulemaking does not have federalism 1310.05(d)). Existing standard industry 601–612). DEA has been able to identify implications warranting the application reports containing the required only one U.S. distributor that lists of Executive Order 13132. information will be acceptable, ergocristine among its products. Unfunded Mandates Reform Act of 1995 Because most of the firm’s product provided the information is readily This rule will not result in the source appears to be located outside the retrievable from the report. expenditure by state, local, and tribal U.S. and because DEA has not been able Title 21 CFR 1310.05(a) requires that governments, in the aggregate, or by the to identify any U.S. manufacturer that each regulated person shall report to private sector, of $120,000,000 or more produces a product containing DEA any regulated transaction involving (adjusted for inflation) in any one year, ergocristine, DEA does not consider it an extraordinary quantity of a listed and will not significantly or uniquely likely that this domestic distributor chemical, an uncommon method of affect small governments. Therefore, no would be subject to the rule, unless they payment or delivery, or any other actions were deemed necessary under imported ergocristine. The only circumstance that the regulated person the provisions of the Unfunded probable legitimate commerce in this believes may indicate that the listed Mandates Reform Act of 1995. chemical appears to be the use of chemical will be used in violation of the ergocristine as precursor material for the Congressional Review Act CSA and its corresponding regulations. synthesis of a research compound. If This rule is not a major rule as Persons are also required to report any used for this purpose, then there would defined by Section 804 of the proposed regulated transaction with a be a registration and recordkeeping Congressional Review Act/Small person whose description or other requirement for this distributor to Business Regulatory Enforcement identifying characteristics the import the ergocristine. Such use would Fairness Act of 1996 (Congressional Administration has previously likely be extremely limited. Therefore, Review Act). This rule will not result in furnished to the regulated person; any the Deputy Administrator certifies that an annual effect on the economy of unusual or excessive loss or this rule will not have a significant $100,000,000 or more; a major increase disappearance of a listed chemical economic impact on a substantial in cost or prices; or significant adverse under the control of the regulated number of small entities. effects on competition, employment, person; any in-transit loss in which the investment, productivity, innovation, or regulated person is the supplier; and Executive Order 12866 on the ability of United States-based any domestic regulated transaction in a The Deputy Administrator certifies companies to compete with foreign- based companies in domestic and tableting or encapsulating machine. that this rulemaking has been drafted in export markets. Import/Export. All imports, exports, accordance with the principles in and international transactions of a listed Executive Order 12866 Section 1(b). It List of Subjects in 21 CFR Part 1310 chemical shall comply with the CSA has been determined that this is ‘‘a Drug traffic control, Exports, Imports, import and export provisions including significant regulatory action.’’ Therefore, Reporting and recordkeeping 21 U.S.C. 957 and 971. Regulations for this action has been reviewed by the requirements. importation and exportation of List I Office of Management and Budget. DEA For the reasons set out above, 21 CFR chemicals are described in 21 CFR part has not conducted an economic analysis part 1310 is proposed to be amended as 1313. of the proposed rule because DEA has follows: Security. All applicants and been able to identify only one company registrants shall provide effective with a U.S. address that lists PART 1310—RECORDS AND controls against theft and diversion of ergocristine among its products. DEA REPORTS OF LISTED CHEMICALS chemicals as described in 21 CFR was able to identify only two foreign AND CERTAIN MACHINES firms that list ergocristine as a product. 1309.71. 1. The authority citation for part 1310 These firms appear to sell ergocristine continues to read as follows: Administrative Inspection. Places, as an active pharmaceutical ingredient, including factories, warehouses, or but a search of the Food and Drug Authority: 21 U.S.C. 802, 827(h), 830, other establishments and conveyances, Administration’s database of approved 871(b), 890. where registrants or other regulated drugs did not identify any drug with 2. Section 1310.02 is amended by persons may lawfully hold, ergocristine as an active ingredient. adding a new paragraph (a)(30) to read manufacture, distribute, dispense, Consequently, DEA does not believe as follows: administer, or otherwise dispose of a that at this time any firm conducting § 1310.02 Substances covered. regulated chemical/chemical mixture or legitimate business is likely to have to where records relating to those activities * * * * * comply with the rule. (a) * * * are kept or required to be kept, are (30) Ergocristine and its salts 8612 controlled premises as defined in 21 Executive Order 12988 * * * * * CFR 1316.02(c). The CSA (21 U.S.C. This regulation meets the applicable 3. Section 1310.04 is amended by 880) allows for administrative standards set forth in Sections 3(a) and redesignating paragraphs (g)(1)(ii) inspections of these controlled premises 3(b)(2) of Executive Order 12988, Civil through (g)(1)(vii) as paragraphs as provided in 21 CFR 1316 Subpart A. Justice Reform. (g)(1)(iii) through (g)(1)(viii), and adding

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a new paragraph (g)(1)(ii) to read as the registration requirement, provided subsequently denied by DEA must follows: that DEA receives a properly completed obtain a registration with DEA. A application for registration or temporary exemption from the § 1310.04 Maintenance of records. application for exemption for a registration requirement will also be * * * * * chemical mixture containing provided for those persons whose (g) * * * ergocristine and its salts pursuant to applications for exemption are denied, (1) * * * Section 1310.13 of this part on or before provided that DEA receives a properly (ii) Ergocristine and its salts (30 days after publication of a Final completed application for registration * * * * * Rule implementing regulations on or before 30 days following the date 4. Section 1310.09 is amended by regarding ergocristine). The exemption of official DEA notification that the adding new paragraph (k) to read as will remain in effect for each person application for exemption has been follows: who has made such application until denied. The temporary exemption for the Administration has approved or such persons will remain in effect until § 1310.09 Temporary exemption from denied that application. This exemption DEA takes final action on their registration. applies only to registration; all other registration application. * * * * * chemical control requirements set forth 5. Section 1310.12(c) is amended by (k)(1) Each person required under in the Act and parts 1309, 1310, 1313, adding in alphabetical order an entry Sections 302 and 1007 of the Act (21 and 1316 of this chapter remain in full ‘‘Ergocristine and its salts’’ in the table U.S.C. 822, 957) to obtain a registration force and effect. ‘‘Table of Concentration Limits’’ to read to manufacture, distribute, import, or (2) Any person who manufactures, as follows: export regulated ergocristine and its distributes, imports or exports a salts, including regulated chemical chemical mixture containing § 1310.12 Exempt chemical mixtures. mixtures pursuant to Section 1310.12 of ergocristine and its salts whose * * * * * this part, is temporarily exempted from application for exemption is (c) * * *

TABLE OF CONCENTRATION LIMITS

DEA chemical code number Concentration Special conditions

List I Chemicals

******* Ergocristine and its salts ...... 8612 Not exempt at any concentra- Chemical mixtures containing tion. any amount of ergocristine and its salts are not exempt.

*******

* * * * * standards for existing, new and A. http://www.regulations.gov. Follow Dated: February 12, 2010. modified stationary sources in Virginia. the on-line instructions for submitting Michele M. Leonhart, In the Final Rules section of this comments. B. E-mail: Deputy Administrator. Federal Register, EPA is approving the State’s SIP submittal as a direct final [email protected]. [FR Doc. 2010–3701 Filed 2–23–10; 8:45 am] rule without prior proposal because the C. Mail: EPA–R03–OAR–2010–0009, BILLING CODE 4410–09–P Agency views this as a noncontroversial Cristina Fernandez, Associate Director, submittal and anticipates no adverse Office of Air Program Planning, comments. A detailed rationale for the Mailcode 3AP30, U.S. Environmental ENVIRONMENTAL PROTECTION approval is set forth in the direct final Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania AGENCY rule. If no adverse comments are 19103. 40 CFR Part 52 received in response to this action, no D. Hand Delivery: At the previously- further activity is contemplated. If EPA listed EPA Region III address. Such [EPA–R03–OAR–2010–0009; FRL–9115–8] receives adverse comments, the direct deliveries are only accepted during the final rule will be withdrawn and all Approval and Promulgation of Air Docket’s normal hours of operation, and public comments received will be special arrangements should be made Quality Implementation Plans; Virginia; addressed in a subsequent final rule Opacity Source Surveillance Methods for deliveries of boxed information. based on this proposed rule. EPA will Instructions: Direct your comments to AGENCY: Environmental Protection not institute a second comment period. Docket ID No. EPA–R03–OAR–2010– Agency (EPA). Any parties interested in commenting 0009. EPA’s policy is that all comments ACTION: Proposed rule. on this action should do so at this time. received will be included in the public DATES: Comments must be received in docket without change, and may be SUMMARY: EPA proposes to approve the writing by March 26, 2010. made available online at http:// State Implementation Plan (SIP) www.regulations.gov, including any revision submitted by the ADDRESSES: Submit your comments, personal information provided, unless Commonwealth of Virginia for the identified by Docket ID Number EPA– the comment includes information purpose of updating methods for R03–OAR–2010–0009 by one of the claimed to be Confidential Business determining compliance with opacity following methods: Information (CBI) or other information

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