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Dated: July 20, 2007. Persons seeking registration must business information to be redacted Deborah J. Spero, apply on or before August 24, 2007 in within the comment. If a comment has Acting Commissioner, Customs and Border order to continue their business pending so much confidential business Protection. final action by DEA on their application. information that it cannot be effectively [FR Doc. E7–14406 Filed 7–24–07; 8:45 am] Written comments must be postmarked, redacted, all or part of that comment BILLING CODE 9111–14–P and electronic comments must be sent, may not be posted on http:// on or before September 24, 2007. www.regulations.gov. ADDRESSES: To ensure proper handling Personal identifying information and DEPARTMENT OF JUSTICE of comments, please reference ‘‘Docket confidential business information No. DEA–284I’’ on all written and identified and located as set forth above Drug Enforcement Administration electronic correspondence. Written will be redacted and placed in the comments being sent via regular mail agency’s public docket file, and, where 21 CFR Part 1310 should be sent to the Deputy possible, posted online. If you wish to inspect the agency’s public docket file [Docket No. DEA–284I] Administrator, Drug Enforcement Administration, Washington, DC 20537, in person by appointment, please see RIN 1117–AB11 Attention: DEA Federal Register the FOR FURTHER INFORMATION paragraph. Representative/ODL. Written comments FOR FURTHER INFORMATION CONTACT: Elimination of Exemptions for sent via express mail should be sent to Christine A. Sannerud, PhD, Chief, Drug Chemical Mixtures Containing the List DEA Headquarters, Attention: DEA & Chemical Evaluation Section, Office I Chemicals Ephedrine and/or Federal Register Representative/ODL, of Diversion Control, Drug Enforcement 2401 Jefferson-Davis Highway, Administration, Washington, DC 20537, telephone (202) 307–7183, fax (202) AGENCY: Drug Enforcement Alexandria, VA 22301. Comments may Administration (DEA), Department of be sent directly to DEA electronically by 353–1263, or e-mail [email protected]. Justice. sending an electronic message to SUPPLEMENTARY INFORMATION: ACTION: Interim rule with request for [email protected]. I. Background comments. Comments may also be sent electronically through http:// Status of Dietary Supplements SUMMARY: This Interim Rule removes the www.regulations.gov using the Containing Ephedrine and/or Controlled Substances Act (CSA) electronic comment form provided on Pseudoephedrine exemptions for chemical mixtures that site. An electronic copy of this Dietary supplements containing the containing ephedrine and/or document is also available at the List I chemicals ephedrine or pseudoephedrine with concentration http://www.regulations.gov Web site. pseudoephedrine are regulated as limits at or below five percent. The DEA will accept attachments to chemical mixtures under the Controlled Combat Methamphetamine Epidemic electronic comments in Microsoft Word, Substances Act (CSA). DEA originally Act of 2005 (CMEA) added additional WordPerfect, Adobe PDF, or Excel file exempted these products from CSA controls on ephedrine and formats only. DEA will not accept any regulatory control if the total pseudoephedrine and mandated that file format other than those specifically concentration of the ephedrine and/or DEA limit the domestic production and listed here. pseudoephedrine was at or below five importation of materials containing Posting of Public Comments: Please percent, in an effort to reduce the ephedrine and pseudoephedrine to note that all comments received are regulatory burden on the dietary and quantities necessary for medical, considered part of the public record and nutritional supplement industry (68 FR scientific and other legitimate purposes made available for public inspection 23195, May 1, 2003). However, on (21 U.S.C. 952(a)(1) as amended). DEA online at http://www.regulations.gov. February 11, 2004, the Food and Drug is eliminating exemptions for these Such information includes personal Administration (FDA) issued a Final chemical mixtures. As such, all identifying information (for example, Rule (69 FR 6787) declaring dietary ephedrine and pseudoephedrine name, address, etc.) voluntarily supplements containing ephedrine chemical mixtures, regardless of submitted by the commenter. adulterated under the Federal concentration and form, shall be subject If you want to submit personal Food, Drug, and Cosmetic Act (the to the regulatory provisions of the CSA. identifying information (such as your FFD&C Act) because these dietary DEA is not prohibiting the name, address, etc.) as part of your supplements present an unreasonable importation, exportation, manufacture, comment, but do not want it to be risk of illness or injury. Effective April or distribution of chemical mixtures posted online, you must include the 12, 2004, the rule prohibits the sale of containing ephedrine or phrase ‘‘PERSONAL IDENTIFYING dietary supplements containing pseudoephedrine in concentrations less INFORMATION’’ in the first paragraph ephedrine alkaloids such as than or equal to five percent. Rather, of your comment. You must also place (also known as Ma Huang, sida DEA is regulating the importation, all the personal identifying information cordifolia and pinellia). The effect of the exportation, manufacture, and you do not want posted online in the FDA rule was to ban the lawful distribution of these chemical mixtures first paragraph of your comment and marketing of these products. by requiring persons who handle these identify the information you want DEA notes that the FDA ban addresses chemical mixtures to register with DEA, redacted. only the marketing of dietary maintain certain records common to If you want to submit confidential supplements containing ephedrine business practice, and file certain business information as part of your alkaloids. The raw materials used to reports, regarding these chemical comment but do not want it to be posted manufacture these dietary supplements mixtures. Chemical mixtures containing online, you must include the phrase are not restricted by the FDA ban. the List I chemicals ephedrine and ‘‘CONFIDENTIAL BUSINESS Accordingly, to control those materials, pseudoephedrine will still be available INFORMATION’’ in the first paragraph DEA must address the importation, for use. of your comment. You must also exportation, manufacture, or DATES: Effective August 24, 2007. prominently identify confidential distribution of chemical mixtures with

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concentration limits of ephedrine and/ alkaloids include sea grape, yellow initial success in curtailing the or pseudoephedrine at or below five horse, joint fir, popotillo, and country diversion of chemicals, traffickers soon percent. The importation, exportation, mallow. Although the proportions of the found and took advantage of certain manufacture, and distribution of various ephedrine alkaloids in botanical shortcomings in the law. In the United chemical mixtures with concentration species vary from one species to States (U.S.), traffickers were able to limits at or below five percent another, in most species used obtain needed supplies by purchasing ephedrine and/or pseudoephedrine are commercially, ephedrine is typically the products that were exempted from addressed by the CSA and its predominant in the raw regulation under the CDTA. Such implementing regulations. As there yet material. In addition to chemical products include chemical mixtures. may be legitimate uses for chemical mixtures from synthetic sources, this Chemical Mixture Definition mixtures with concentration limits at or rulemaking includes those sources below five percent, the importation, that contain the ephedrine alkaloids, The CDTA created a definition of exportation, manufacture, and ephedrine and/or pseudoephedrine. ‘‘chemical mixture’’ (21 U.S.C. 802(40)), distribution of these chemical mixtures The names desert herb, squaw tea, and exempted chemical mixtures from (for purposes other than use in dietary Brigham tea, and Mormon tea refer to the definition of ‘‘regulated supplements containing ephedrine North American species of ephedra that transaction.’’ (21 U.S.C. 802(39)(A)(vi) alkaloids) are not prohibited by either do not contain ephedrine alkaloids but as amended by CMEA) Chemical FDA’s ban regarding the marketing of have been misused to identify mixtures are defined as ‘‘a combination such dietary supplements or by DEA ephedrine alkaloid containing of two or more chemical substances, at law and regulations. Accordingly, as ingredients. This rulemaking does not least one of which is not a list I discussed further below, for DEA to pertain to species of ephedra that do not chemical or a List II chemical, except regulate the importation, exportation, contain ephedrine and/or that such term does not include any manufacture, and distribution of pseudoephedrine. combination of a List I chemical or a chemical mixtures containing ephedrine List II chemical with another chemical Combat Methamphetamine Epidemic that is present solely as an impurity.’’ and/or pseudoephedrine with Act of 2005 (CMEA) concentration limits at or below five (21 U.S.C. 802(40)) percent, DEA must remove these On March 9, 2006, the President signed the Combat Methamphetamine Chemical Mixtures Containing chemical mixtures from their exempt Ephedrine and Pseudoephedrine status under CSA regulations. Epidemic Act of 2005 (CMEA), which is DEA recognizes that ephedra Title VII of the USA PATRIOT Ephedrine and pseudoephedrine are materials containing ephedrine and/or Improvement and Reauthorization Act List I chemicals. Listed chemicals that pseudoephedrine are used legitimately of 2005. The CMEA mandates that DEA are classified as List I chemicals are by practitioners of Traditional Chinese limit the domestic production and important to the manufacture of Medicine. This rulemaking does not importation of materials containing controlled substances. Chemical restrict the utilization of such material ephedrine and pseudoephedrine mixtures containing both these List I for such legitimate purposes. This (including ephedra) to quantities chemicals include dietary and rulemaking will simply require necessary for medical, scientific and nutritional supplements. Prior to FDA’s importers and suppliers of such material other legitimate purposes (21 U.S.C. 826 2004 Final Rule, dietary and nutritional to comply with DEA recordkeeping, and 952(a)(1) as amended). DEA is supplements containing both of these registration, quota and import/export concerned about the illicit use of chemicals were readily available in the requirements. ephedra type material in the clandestine U.S., commonly sold to the public in production of methamphetamine. While drug and grocery stores, health and Plant Material Included in This the legitimate market for dietary nutrition stores, and through direct Regulatory Action supplements containing such material marketing campaigns. These dietary and The ephedrine alkaloids, including, has been cut by FDA’s recent action, nutritional supplements contained among others, ephedrine, DEA has seen an increasing number of ephedra plant material, or extracts from pseudoephedrine, norephedrine, N- requests for importation of below-five the ephedra plant. If these dietary and methylephedrine, norpseudoephedrine, percent ephedrine and/or nutritional supplements met certain N-methylpseudoephedrine, are pseudoephedrine material. DEA notes criteria under the FFD&CA, they were chemical that occur naturally that there may be legitimate uses for not recognized as drugs under the in some botanicals, but can be these chemical mixtures. However, in FFD&CA, but nonetheless were synthetically derived. The ingredient light of FDA’s action, DEA is concerned considered to be chemical mixtures sources of the ephedrine alkaloids about the intended purpose of such governed by DEA law and regulations. include raw botanicals (i.e., ) and material, especially given that such In contrast, over-the-counter (OTC) and extracts from botanicals. Ma Huang, material has been seized in clandestine prescription drug products containing ephedra, Chinese Ephedra, and epitonin drug laboratories. these listed chemicals are not are several names used for botanical considered chemical mixtures (as long Chemical Mixture Regulatory Control ingredients, primarily from Ephedra as they are in final FDA approved History sinica Stapf, ephedra equisetina Bunge, labeled package form) and instead are Ephedra intermedia var. tibetica Stapf The Chemical Diversion and specifically addressed in 21 U.S.C. and Linne. (the Trafficking Act of 1988 (Pub. L. 100– 802(39)(A)(iv) and (v) as amended by ), that are sources of ephedrine 690) (CDTA) was passed by Congress to CMEA. Also see 21 CFR alkaloids (including ephedrine and curtail the diversion of specific 1300.02(b)(28)(i). pseudoephedrine). Other plant sources chemicals used in the illicit that contain such ephedrine alkaloids manufacture of controlled substances. Initial Chemical Mixture Controls include Sida cordifolia L. and Pinellia The CDTA established recordkeeping Prior to the Domestic Chemical ternata (Thunb.) Makino. Common and reporting requirements necessary Diversion Control Act of 1993 (DCDCA), names that have been used for the for DEA to identify and track chemical enacted in April of 1994, transactions various plants that contain ephedrine diversion. While the CDTA achieved involving all chemical mixtures

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(including dietary supplements) were regulatory controls. Additionally, the Recent FDA Action Pertaining to Dietary exempt from recordkeeping, registration NPRM defined an application process Supplements Containing Ephedrine and other chemical regulatory control by which manufacturers may apply for Alkaloids requirements of the CSA. The DCDCA an exemption for chemical mixtures that In 2004, FDA issued a Final Rule amended the CSA (21 U.S.C. do not qualify for automatic exemption. declaring dietary supplements The DEA proposed that each chemical 802(39)(A)(v)) to limit the application of containing ephedrine alkaloids be assigned a concentration limit that, if the above stated exemption and ‘‘adulterated’’ under the FFD&C Act (69 found at or below the limit, will cause provided the Attorney General with the FR 6787, February 11, 2004). FDA the mixture to be treated as exempt from authority to exempt a chemical mixture issued this rule after concluding that specific provisions of the CSA. This containing a listed chemical if it is these products present an unreasonable ‘‘formulated in such a way that it cannot quantitative approach to identifying risk of illness or injury. FDA’s Final be easily used in the illicit production regulated mixtures was considered Rule prohibits the sale of these products of a controlled substance’’ and ‘‘the necessary due to the complexity of and FDA has been seizing dietary listed chemical or chemicals contained chemical-based commodities and the supplements containing ephedrine in the mixture cannot be readily huge variety of products. These criteria alkaloids since the Final Rule became recovered.’’ As such, only those were expected to exempt the vast effective in April 2004. The FDA Final chemical mixtures meeting these criteria majority of chemical mixtures Rule addressed the marketing of dietary would be exempted from control. Until containing listed chemicals from supplements containing ephedrine regulations which delineated criteria regulatory control. The NPRM included alkaloids; it did not address the and procedures for exempting specific the proposed creation of a ‘‘Table of chemical mixtures were finalized, as a Concentration Limits,’’ in 21 CFR importation, exportation, manufacture practical interpretation of the law, DEA 1310.12. This table lists the or distribution of ephedrine and/or treated all chemical mixtures, including concentration limits for each listed pseudoephedrine chemical mixtures dietary and nutritional supplements, as chemical. with concentration limits at or below being exempt from the chemical In recognition that not all mixtures five percent, if the chemical mixture is regulatory requirements of the CSA. that qualify for exemption can be not being marketed as a dietary (Note that OTC and prescription drug identified by concentration or category, supplement containing ephedrine products are not considered chemical the DEA also proposed an application alkaloids. DEA notes that there yet may mixtures and are addressed separately process to exempt additional mixtures be legitimate uses for such mixtures. As under 21 U.S.C. 802(39)(A)(iv)). Unless which are not likely to be diverted for there yet may be legitimate uses for exempted pursuant to law and use in the illicit production of chemical mixtures with concentration regulations, the requirements for controlled substances. limits at or below 5 percent, the chemical mixtures included registration DEA originally proposed a importation, exportation, manufacture, for certain handlers of List I chemicals, concentration limit of two percent for and distribution of these chemical recordkeeping, reporting and security. chemical mixtures containing ephedrine mixtures (for purposes other than use in and/or pseudoephedrine. However, dietary supplements containing Concern Regarding Chemical Mixtures based on the comments received from ephedrine alkaloids) are not prohibited Some chemical mixtures can be and the NPRM (63 FR 49506, Sept. 16, by either FDA’s ban regarding the have been used by traffickers in the 1998), DEA determined that a five marketing of such dietary supplements illicit manufacture of controlled percent concentration limit would be or by DEA law and regulations. In spite substances. This exemption provided more appropriate. On May 1, 2003, DEA of FDA’s ban, and corresponding traffickers with an unregulated source published a Final Rule (68 FR 23195) reduction in legitimate need for these for obtaining these chemicals. To which established a concentration limit chemical mixtures, DEA has seen a address these problems, the DCDCA of five percent for chemical mixtures significant increase in the number of amended the exemption to provide that which contain ephedrine and/or import requests for ephedra, sparking a only those chemical mixtures specified pseudoephedrine. concern that these chemical mixtures by regulation would be exempt from the If the concentration of the total are being diverted for use in the illicit definition of ‘‘regulated transaction.’’ ephedrine and/or pseudoephedrine was manufacture of methamphetamine. Regulations regarding the exemption at or below the five percent limit in a of chemical mixtures were initially chemical mixture, the mixture was Combat Methamphetamine Epidemic proposed by DEA on October 13, 1994 automatically exempted from the Act of 2005 (CMEA) (59 FR 51888). In response to industry registration, reporting, recordkeeping On March 9, 2006, the President concerns, the proposed regulations were and security requirements of the CSA. signed the USA PATRIOT Improvement withdrawn on December 9, 1994 (59 FR That Final Rule primarily addressed and Reauthorization Act of 2005 which 63738). After consulting with the those chemicals encountered in dietary included the Combat Methamphetamine private sector and carefully considering and nutritional supplements. Epidemic Act of 2005 (CMEA) (Title VII industry and other concerns, new The May 1, 2003, Final Rule also of Pub. L. 109–177). The CMEA placed regulations regarding chemical mixtures established an exemption for the additional controls on ephedrine and were proposed on September 16, 1998 category of products consisting of pseudoephedrine and tasked DEA with (63 FR 49506). The comment period, unaltered harvested plant material in 21 limiting the domestic production and which was twice extended, closed on CFR 1310.12(d)(1). Finally, that rule importation of ephedrine and April 16, 1999. provided for a process whereby a pseudoephedrine materials to quantities There are thousands of chemical manufacturer of a product which would necessary for medical, scientific and mixtures in legitimate commerce, the otherwise be subject to regulation may other legitimate purposes (21 U.S.C. 826 majority of which are not useful to the request an exemption for that specific and 952(a)(1) as amended). illicit laboratory operator. The NPRM product. This process allows chemical The CMEA imposed new proposed criteria for the determination mixtures not automatically exempt by requirements regarding the retail sale of of whether a chemical mixture would be the concentration limit to be considered scheduled listed chemical products automatically exempt from CSA for exempt status under the CSA. (products containing ephedrine,

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pseudoephedrine, or Congressional mandate of restricting DEA is concerned that these products phenylpropanolamine, that may be such material to quantities necessary for would be more widely diverted for marketed or distributed lawfully in the medical, scientific, and other legitimate illicit production of methamphetamine, United States under the FFD&CA as purposes (21 U.S.C. 826 and 952(a)(1) as particularly as traffickers look for easily- nonprescription products). In a separate amended). Without removing the obtainable product due to the new retail rulemaking, ‘‘Retail Sales of Scheduled exemption for these products, DEA sales, quota and import restrictions Listed Chemical Products; Self- would be unable to effectively limit the imposed by CMEA. importation of ephedrine and Certification of Regulated Sellers of DEA Concerns Regarding Recent pseudoephedrine, as required by the Scheduled Listed Chemical Products’’ Importations [Docket No. DEA–291, RIN 1117–AB05] CMEA. (71 FR 56008, September 26, 2006; Recently DEA has seen an increasing Present Concerns: Use at Illicit number of requests for importation of corrected at 71 FR 60609, October 13, Laboratories 2006), DEA promulgated regulations large shipments of ephedra material in implementing these provisions. The DEA is also authorized to remove an concentrations below the five percent CMEA also subjects material containing exemption for particular exempt ephedrine and pseudoephedrine ephedrine, pseudoephedrine and chemical mixtures if it finds evidence of exemption limit. Traditionally, such phenylpropanolamine to manufacturing diversion pursuant to 21 CFR ephedra extract material has always and import restrictions. Specifically, the 1310.12(e). This regulation provides that been between 6–8 percent ephedrine CMEA requires that importers of all should DEA find such evidence, it can and/or pseudoephedrine. listed chemicals provide DEA with ‘‘issue, and publish in the Federal As noted above, DEA has seen information regarding the transferee, Register, notification of the removal of chemical mixtures with concentration limits of ephedrine and/or (i.e., the downstream customer) of the an exemption.’’ Interested parties are pseudoephedrine at or below five chemical, as well as information invited to file written comments or percent in clandestine regarding the quantity of the chemical to objections to the order within 60 days methamphetamine laboratories. be transferred. Importers are further of the date of publication. If any Subsequent to implementing regulations required to provide DEA with a return comment or objection raises ‘‘significant which allowed an exemption for below declaration regarding each import after issues regarding any finding of fact or five percent material, DEA has the transaction is completed (CMEA conclusion of law upon which the order is based, [DEA] shall immediately witnessed increased ability of section 716, 21 U.S.C. 971(d) and (g), as suspend the effectiveness of the order’’ clandestine laboratory operators to amended). In a separate rulemaking, and reconsider the application for extract ephedrine and pseudoephedrine ‘‘Implementation of the Combat exemption in light of the comments from various bulk materials (including Methamphetamine Epidemic Act of received. low concentration mixtures). These 2005; Notice of Transfers Following At most methamphetamine extraction procedures are shared via the Importation or Exportation’’ [Docket No. laboratories seized in the U.S., the Internet. While these mixtures may DEA–292, RIN 1117–AB06] (72 FR precursor material was obtained via the contain low concentrations of ephedrine 17401, April 9, 2007; Temporary Stay of diversion of OTC ephedrine or and/or pseudoephedrine, they can be a Certain Provisions 72 FR 28601, May 22, pseudoephedrine products marketed in ready source of supply for 2007), DEA promulgated regulations tablet and capsule form. While the vast methamphetamine traffickers. implementing these provisions. Further, majority of products seized at illicit Therefore, due to the existing the CMEA requires that the notice of methamphetamine laboratories were clandestine methamphetamine importation (DEA Form 486) for OTC drug products, ephedra and ma laboratory problem and the illicit use of ephedrine, pseudoephedrine, and huang extracts containing ephedrine, N- extracts and dietary supplements phenylpropanolamine ‘‘shall include all methylephedrine, N- (containing ephedrine and related List I information known to the importer on methylpseudoephedrine, chemicals) as precursor material for the the chain of distribution of such norpseudoephedrine, clandestine production of chemical from the manufacturer to the phenylpropanolamine, and methamphetamine, and the new importer.’’ (CMEA section 721, 21 pseudoephedrine, and dietary limitations imposed by the CMEA, DEA U.S.C. 971(h) as amended). In a separate supplement products (containing is removing the exemption for chemical rulemaking, ‘‘Information of Foreign ephedra and ma huang extracts) have mixtures having a total concentration of Chain of Distribution for Certain List I been seized. At this time, the frequency less than (or equal to) five percent Chemicals’’ [Docket No. DEA–295, RIN with which these dietary supplement ephedrine or pseudoephedrine and is 1117–AB07], DEA is promulgating products and extracts are encountered is removing the exemption for unaltered regulations to implement this provision. small. From 1998 through 2005, DEA ephedra plant material. Finally, the CMEA requires DEA to has documented 20 methamphetamine establish import and production quotas laboratories where ephedra materials Action Taken in This Interim Rule for ephedrine, pseudoephedrine, and have been seized. The source of This Interim Rule announces the phenylpropanolamine (CMEA sections precursor chemicals in a seized removal of the exemption for chemical 713 and 715, 21 U.S.C. 826 and 952 as clandestine laboratory is often not mixtures having a total concentration of amended). In a separate rulemaking, evident, so it is likely that the number ephedrine and/or pseudoephedrine of ‘‘Import and Production Quotas for of seized laboratories that used such five percent (or less). By removing these Certain List I Chemicals’’ [Docket No. mixtures is actually greater. Ephedra, exemptions, all chemical mixtures DEA–293, RIN 1117–AB08] (72 FR therefore, can and is being diverted for containing ephedrine and/or 37439, July 10, 2007) DEA promulgated use as a precursor material for the illicit pseudoephedrine will be regulated regulations to implement these production of methamphetamine. Were chemical mixtures subject to control provisions. DEA not to regulate chemical mixtures under the Controlled Substances Act, DEA is removing the exemption for containing ephedrine and/or including registration, recordkeeping, five percent ephedrine and/or pseudoephedrine at or below the reporting, and security controls. This pseudoephedrine, in part, to fulfill the current five percent concentration limit, action will be effective August 24, 2007.

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This rulemaking also removes the 2007. The temporary exemption for products containing these chemicals, exemption for the category of products such persons will remain in effect until and uses or attempts to use the Postal consisting of harvested plant material DEA takes final action on their Service or any private or commercial which is specified in 21 CFR application for registration. carrier must file monthly reports of each 1310.12(d)(1). Harvested plant material The temporary exemption applies such transaction. (i.e., ephedra) that contains ephedrine, solely to the registration requirement; Imports/Exports. All imports/exports N-methylephedrine, N- all other chemical control requirements, and brokered transactions of regulated methylpseudoephedrine, including recordkeeping and reporting, mixtures containing ephedrine and/or norpseudoephedrine, are effective on August 24, 2007. pseudoephedrine shall comply with the phenylpropanolamine, and/or Therefore, all transactions of chemical CSA (21 U.S.C. 952, 957 and 971). pseudoephedrine, meeting the mixtures containing ephedrine or Regulations for importation and definition of chemical mixture, shall no pseudoephedrine will be regulated, if at exportation of List I chemicals are longer be exempt from CSA provisions, or above threshold, while an application described in 21 CFR part 1313. Separate even when the plant material is for registration or exemption is pending. registration is necessary for each activity unaltered from its natural state. This is necessary because not regulating (21 CFR 1309.22). these transactions could result in II. Provisions Specifically Applying to Security. Regulated persons must increased diversion of chemicals provide effective controls and Regulated Chemical Mixtures desirable to drug traffickers. Containing These List I Chemicals procedures to guard against theft and Additionally, the temporary diversion of regulated mixtures. Effective August 24, 2007, any exemption does not suspend applicable Regulated persons must store the chemical mixture that contains federal criminal laws relating to the regulated mixtures in containers sealed ephedrine or pseudoephedrine will be regulated mixture, nor does it supersede so that tampering will be evident; if the treated as a List I chemical. Transactions state or local laws or regulations. All mixture cannot be stored in a sealed that meet or exceed the cumulative handlers of a regulated mixture must container, access to the chemicals must monthly threshold for the listed comply with applicable state and local be controlled (21 CFR 1309.71). chemical, set forth at 21 CFR 1310.04, requirements in addition to the CSA Administrative Inspection. Places, shall be regulated transactions. Persons regulatory controls. including factories, warehouses, or interested in handling a regulated Records and Reports. The CSA (21 other establishments and conveyances, mixture must comply with the U.S.C. 830) requires certain records to where regulated persons may lawfully following: be kept and reports to be made hold, manufacture, or distribute, Registration. Any person who involving listed chemicals. Regulations dispense, administer, or otherwise manufactures, distributes, imports or describing recordkeeping and reporting dispose of a regulated mixture or where exports a regulated mixture, or proposes requirements are set forth in 21 CFR records relating to those activities are to engage in such activities, with respect Part 1310. A record must be made and maintained, are controlled premises as to a regulated mixture containing a List maintained for two years after the date defined in 21 CFR 1316.02(c). The CSA I chemical, shall obtain a registration of a regulated transaction involving a (21 U.S.C. 880) allows for administrative pursuant to the CSA (21 U.S.C. 822). List I chemical. Only a distribution, inspections of these controlled premises Regulations describing registration for receipt, sale, importation, exportation, as provided in 21 CFR Part 1316 List I chemical handlers are set forth in brokerage or trade of a regulated mixture Subpart A. 21 CFR part 1309. above the established threshold is a Separate registration is required for regulated transaction (21 CFR Regulatory Certifications manufacture, distribution, importing, 1300.02(b)(28)). and exporting. A separate registration is Each regulated bulk manufacturer of a Administrative Procedure Act required for each principal place of regulated mixture shall submit The Administrative Procedure Act business at one general physical manufacturing, inventory, and use data (APA) generally requires that agencies, location where List I chemicals are on an annual basis (21 CFR 1310.05(d)). prior to issuing a new rule, publish a manufactured, distributed, imported, or Bulk manufacturers producing the notice of proposed rulemaking in the exported by a person (21 CFR 1309.23). mixture solely for internal consumption, Federal Register. The APA also Effective August 24, 2007, any person e.g. formulating a nonregulated mixture, provides, however, that agencies may be manufacturing, distributing, importing, are not required to submit this excepted from this requirement when or exporting any amount of a regulated information. Existing standard industry ‘‘the agency for good cause finds (and mixture will become subject to the reports containing the required incorporates the finding and a brief registration requirement under the CSA. information are acceptable, provided the statement of reasons therefor in the DEA recognizes, however, that it is not information is readily retrievable from rules issued) that notice and public possible for persons who are subject to the report. procedure thereon are impracticable, the registration requirement to 21 CFR 1310.05 requires that each unnecessary, or contrary to the public immediately complete and submit an regulated person shall report to DEA interest.’’ 5 U.S.C. 553(b)(B). application for registration and for DEA any regulated transaction involving an With publication of this interim rule, to immediately issue registrations for extraordinary quantity, an uncommon DEA is invoking this ‘‘good cause’’ those activities. Therefore, in order to method of payment or delivery, or any exception to the APA’s notice allow continued legitimate commerce in other circumstance that causes the requirement based on the combination regulated mixtures, DEA is establishing regulated person to believe that the of several extraordinary factors. Section in 21 CFR 1310.09 a temporary listed chemical will be used in violation 713 of the CMEA (21 U.S.C. 826 as exemption from the registration of the CSA. Section 1310.03(c) requires amended) requires the establishment of requirement for persons desiring to that regulated persons who engage in a production quotas for the List I engage in activities with regulated transaction with a nonregulated person chemicals ephedrine, pseudoephedrine, mixtures, provided that DEA receives a or who engage in an export transaction and phenylpropanolamine. DEA properly completed application for that involves ephedrine or implemented these requirements in a registration on or before August 24, pseudoephedrine, including drug separate rulemaking, ‘‘Import and

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Production Quotas for Certain List I the new requirements limiting with the rule.’’ 5 U.S.C. 553(d)(3). As Chemicals’’ [Docket No. DEA–293, RIN importation of ephedrine, discussed previously, DEA has recently 1117–AB08] (72 FR 37439, July 10, pseudoephedrine, and seen a significant increase in the 2007). DEA cannot establish such quotas phenylpropanolamine, as well as the number of requests for importation of if certain products containing these List establishment of production and import large quantities of these chemical I chemicals are not regulated. To not quotas for these three List I chemicals, mixtures. After the recent FDA action regulate these products while at the necessitate that DEA remove the which bans dietary supplements same time establishing production concentration limit for these previously containing such material, DEA has not quotas would create a loophole which exempt chemical mixtures. Engaging in been able to determine the legitimate traffickers could exploit domestically. traditional notice and comment need for importation of such material. CMEA also mandates that imports of rulemaking would prevent DEA from DEA is concerned about the potential ephedrine, pseudoephedrine, and complying with the mandates of CMEA illicit use of such material for phenylpropanolamine are prohibited to limit the importation and domestic clandestine methamphetamine except for such quantities as the production of these materials. manufacture, particularly as traffickers Attorney General (DEA by delegation) Were DEA not to regulate chemical look for easily-obtainable product due to finds necessary to provide for medical, mixtures containing ephedrine and/or the retail sales limits recently imposed scientific, or other legitimate purposes pseudoephedrine at or below the by the CMEA. Delaying the effective (CMEA section 715, 21 U.S.C. 952 as current five percent concentration limit, date of this rule could provide a amended). DEA is further required to DEA is concerned that these products significant loophole for domestic illicit establish import quotas for these three would be more widely diverted for methamphetamine manufacturers to List I chemicals. In order for DEA to illicit production of methamphetamine, take advantage of for their illegal establish quotas and meet its obligation particularly with the new quota and activities. Therefore, DEA finds good to prohibit imports except those import restrictions imposed by CMEA. cause not to delay the effective date of necessary to provide for a medical, Accordingly, DEA finds that it is this rule. scientific, or other legitimate purpose, impracticable to conduct notice and Regulatory Flexibility Act as required by the CMEA, DEA must comment rulemaking regarding the exercise regulatory control over removal of the exemption for chemical The Deputy Administrator hereby chemical mixtures containing mixtures with concentration limits at or certifies that this rulemaking has been pseudoephedrine and ephedrine. To below the current five percent limit. If drafted in accordance with the exercise this control, DEA must DEA did not act in this manner, provisions of the Regulatory Flexibility eliminate the exemption for chemical traffickers would have ready access to Act (RFA) (5 U.S.C. 605(b)). The (RFA) mixtures containing these List I chemical mixtures which DEA has applies to rules that are subject to notice chemicals. demonstrated are being used currently and comment. As explained above, DEA DEA is concerned about the to illicitly manufacture has determined that public notice and increasing number of requests for methamphetamine. Allowing such illicit comment are not necessary. importation of below-five percent manufacture to continue during the Consequently, the RFA does not apply. ephedrine or pseudoephedrine material. pendancy of rulemaking would be DEA notes, however, that as explained After the recent FDA action which bans contrary to the public interest and the in the discussion under Executive Order dietary supplements containing such intent of the Combat Methamphetamine 12866, the costs of this rule are low, material, DEA has not been able to Epidemic Act of 2005. The broad scope requiring only registration, maintenance determine the legitimate need for of the new law, as well as the expedited of records, reports on unusual importation of such material. Therefore, effective dates, is a clear reflection of transactions, thefts or losses, and mail in an effort to eliminate the Congress’ concern about the nation’s order transactions, and security. Other undocumented importation and growing methamphetamine epidemic than the registration fee and the reports, domestic distribution of such material, and its desire to act quickly to prevent these requirements can generally be met and to comply with all of the new further illicit use of these chemicals. by standard business practices. requirements imposed by the CMEA In light of these factors, DEA finds DEA has determined that dietary discussed above, DEA is removing these that ‘‘good cause’’ exists to issue this supplements containing ephedrine exemptions. interim rule without engaging in alkaloids, including bulk material used As has been discussed previously in traditional notice and comment to formulate these supplements, are the this rulemaking, DEA has seized rulemaking. In so doing, DEA recognizes principal chemical mixtures that chemical mixtures containing ephedrine that exceptions to the APA’s notice and contain ephedrine and/or and/or pseudoephedrine with comment procedures are to be pseudoephedrine. Dietary supplements concentrations of less than five percent ‘‘narrowly construed and only containing such ephedrine alkaloids at 20 domestic clandestine laboratories reluctantly countenanced.’’ Am. Fed’n have been banned by FDA. Due to (1) over the past several years. The source of Gov’t Employees v. Block, 655 F2d The CMEA mandate that DEA limit the of precursor chemicals in a seized 1153, 1156 (D.C. Cir. 1981) (quoting domestic production and importation of clandestine laboratory is often not New Jersey Dep’t of Envt. Prot. v. EPA, materials containing ephedrine and evident, so it is likely that the number 626 F.2d 1038, 1045 (D.C. Cir. 1980)). pseudoephedrine to quantities of seized laboratories that used such Based on the totality of the necessary for medical, scientific and mixtures is actually greater. Further, the circumstances associated with the other legitimate purposes; (2) the CMEA specifically prohibits all CMEA, DEA finds that invocation of the elimination of the previous lawful status importation of ephedrine, ‘‘good cause’’ exception is justified. of such products as dietary pseudoephedrine, and Further, the APA also provides that, supplements; and (3) the potential illicit phenylpropanolamine except those while agencies are generally required to use of such products as precursor quantities which the Attorney General publish final rules at least 30 days material for illicit production of finds to be necessary for medical, before they become effective, they may methamphetamine, DEA is removing the scientific, and other legitimate be exempt from this requirement as well exemption for low concentration purposes. These seizures, coupled with ‘‘for good cause found and published material, including harvested plant

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material. This industry is comprised date of shipment; all of this information traffickers to manufacture controlled mainly of small businesses, as defined is available from standard business and substances illicitly. by U.S. Small Business Administration shipping records. These reports may be DEA notes that the lawful marketing (SBA) regulations (13 CFR part 121). filed electronically. The security of dietary supplements containing this However, the lawful marketing of requirements do not exceed standard material has been banned by FDA. As dietary supplements containing business practices for the protection of such, this regulatory action is expected ephedrine alkaloids has been banned by both the security and quality of these to impact no manufacturers, whose FDA. As such, this regulatory action is products. DEA has not determined the product can still lawfully be marketed not expected to impact any number of firms potentially affected by under the FFD&CA. manufacturers whose product can still the rule, but does not expect it to be Therefore, as the impact of this lawfully be marketed under the high. regulation is minimal, DEA is making FFD&CA. Persons who import or minor adjustments to the OMB distribute chemical mixtures containing Executive Order 12988 information collections entitled ephedrine and/or pseudoephedrine at or This regulation meets the applicable ‘‘Application for Registration Under below the previously-exempt five standards set forth in Sections 3(a) and Domestic Chemical Diversion Control percent concentration limit will be 3(b)(2) of Executive Order 12988. Act of 1993 and Renewal Application affected by this rule. This rule will not for Registration under Domestic have a significant economic impact on Executive Order 13132 Chemical Diversion Control Act of those persons. However, DEA is seeking This rulemaking does not preempt or 1993’’ (OMB control number 1117– comment specifically regarding the modify any provision of state law; nor 0031, DEA Form 510), ‘‘Report of Mail potential impacts of this regulation. does it impose enforcement Order Transactions’’ (OMB control DEA is not prohibiting the responsibilities on any state; nor does it number 1117–0033), and ‘‘Import/ importation, exportation, manufacture, diminish the power of any state to Export Declaration for List I and List II or distribution of chemical mixtures enforce its own laws. Accordingly, this Chemicals’’ (OMB control number containing ephedrine or rulemaking does not have federalism 1117–0023). DEA is specifically seeking pseudoephedrine in concentrations less implications warranting the application comment regarding the number of than or equal to five percent. Rather, of Executive Order 13132. persons who may be affected by this DEA is regulating the importation, regulation. exportation, manufacture, and Unfunded Mandates Reform Act of 1995 Congressional Review Act distribution of these chemical mixtures This rule will not result in the This rule is not a major rule as by requiring persons who handle these expenditure by State, local, and tribal defined by Section 804 of the Small chemical mixtures to register with DEA, governments, in the aggregate, or by the Business Regulatory Enforcement maintain certain records common to private sector, of $120,000,000 or more Fairness Act of 1996 (Congressional business practice, and file certain (adjusted for inflation) in any one year, Review Act). This rule will not result in reports, regarding these chemical and will not significantly or uniquely an annual effect on the economy of mixtures. Chemical mixtures containing affect small governments. Therefore, no $100,000,000 or more; a major increase the List I chemicals ephedrine and actions were deemed necessary under in costs or prices; or significant adverse pseudoephedrine will still be available the provisions of the Unfunded effects on competition, employment, for use. Mandates Reform Act of 1995. investment, productivity, innovation, or Executive Order 12866 Paperwork Reduction Act on the ability of United States-based This regulation has been drafted and companies to compete with foreign- The Drug Enforcement reviewed in accordance with Executive based companies in domestic and Administration is eliminating the Order 12866, section 1(b), Principles of export markets. Regulation. DEA has determined that current exemption for chemical this rule is a ‘‘significant regulatory mixtures with concentration limits of List of Subjects in 21 CFR Part 1310 action’’ under Executive Order 12866, the List I chemicals ephedrine and/or Drug traffic control, Exports, Imports, section 3(f), Regulatory Planning and pseudoephedrine of less than or equal to List I and List II chemicals, Reporting Review, and accordingly this rule has five percent. This means that all and Recordkeeping requirements. chemical mixtures containing the List I been reviewed by the Office of I chemicals ephedrine and/or For the reasons set out above, 21 CFR Management and Budget (OMB). part 1310 is amended as follows: The rule will impose relatively low pseudoephedrine are regulated chemical costs on regulated persons. Other than mixtures, regardless of concentration PART 1310—RECORDS AND the annual registration fee of $1,247, limits. REPORTS OF LISTED CHEMICALS there are few costs associated with the Due to this change in the regulations, AND CERTAIN MACHINES [AMENDED] rule. The records required on regulated all persons who import, export, transactions can be met with standard manufacture, or distribute chemical I 1. The authority citation for part 1310 business records. Reports on unusual mixtures containing these two List I continues to read as follows: sales, thefts, and losses will be filed chemicals will be required to register Authority: 21 U.S.C. 802, 827(h), 830, infrequently by any one person. Those with DEA. They will also be required to 871(b), 890. file reports regarding certain who sell covered mixtures and deliver I 2. Section 1310.09 is amended by transactions, should certain criteria be them to the end user through the mail adding a new paragraph (j) to read as met. or other delivery services will have to follows: file a monthly report. The monthly DEA does, however, provide a report requires only the registrant’s mechanism whereby a person may seek § 1310.09 Temporary exemption from name and registration number, the an exemption from these regulatory registration. purchaser’s name and address, the requirements for a specific chemical * * * * * shipping address (if different), the name mixture, if DEA determines that such a (j) Each person required by section and quantity of the chemical, and the chemical mixture cannot be used by 302 of the Act (21 U.S.C. 822) to obtain

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a registration to manufacture, distribute, chapter remain in full force and effect. I 3. Section 1310.12 is amended as import, or export regulated chemical Any person who manufactures, follows: mixtures which contain ephedrine, and/ distributes, imports, or exports a I A. By revising the Table of or pseudoephedrine, pursuant to chemical mixture whose application for Concentration Limits in paragraph (c) by Sections 1310.12 and 1310.13, is exemption is subsequently denied by revising the entries for ‘‘Ephedrine, its temporarily exempted from the DEA must obtain a registration with salts, optical isomers, and salts of registration requirement, provided that DEA. A temporary exemption from the optical isomers’’ and ‘‘Pseudoephedrine, DEA receives a properly completed registration requirement will also be its salts, optical isomers, and salts of application for registration or provided for these persons, provided optical isomers’’; and application for exemption on or before that DEA receives a properly completed August 24, 2007. The exemption will application for registration on or before I B. By removing paragraph (d)(1) and remain in effect for each person who has 30 days following the date of official redesignating paragraphs (d)(2) through made such application until the DEA notification that the application for (d)(5) as paragraphs (d)(1) through (d)(4) Administration has approved or denied exemption has not been approved. The as follows: that application. This exemption applies temporary exemption for such persons § 1310.12 Exempt chemical mixtures. only to registration; all other chemical will remain in effect until DEA takes control requirements set forth in parts final action on their registration * * * * * 1309, 1310, 1313, and 1315 of this application. (c) * * *

TABLE OF CONCENTRATION LIMITS

DEA chemical Concentration code number (percent) Special conditions

List I Chemicals

******* Ephedrine, its salts, optical isomers, and salts of 8113 Not exempt at any con- Chemical mixtures containing any amount of optical isomers. centration. ephedrine and/or pseudoephedrine, and their salts, optical isomers and salts of optical iso- mers are not exempt due to concentration, un- less otherwise exempted.

******* Pseudoephedrine, its salts, optical isomers, and 8112 Not exempt at any con- Chemical mixtures containing any amount of salts of optical isomers. centration. ephedrine and/or pseudoephedrine, and their salts, optical isomers and salts of optical iso- mers are not exempt due to concentration, un- less otherwise exempted.

*******

List II Chemicals

*******

* * * * * LIBRARY OF CONGRESS makes technical corrections to that interim regulation. Dated: July 2, 2007. Copyright Office Michele M. Leonhart, DATES: Effective on July 25, 2007. Deputy Administrator. 37 CFR Part 202 FOR FURTHER INFORMATION CONTACT: [FR Doc. E7–14295 Filed 7–24–07; 8:45 am] Tanya Sandros, Acting General Counsel, [Docket No. RM 2007–7] or Nanette Petruzzelli, Special Legal BILLING CODE 4410–09–P Advisor to the Register for Technical Amendments to online Reengineering, Copyright Office, Library registration of claims to copyright; of Congress, Washington, DC 20540. corrections Telephone: (202) 707–8380. Telefax: AGENCY: Copyright Office, Library of (202) 707–8366. Congress SUPPLEMENTARY INFORMATION: The ACTION: Interim Regulations for online Copyright Office published an interim registration; correction. regulation in the Federal Register on July 6, 2007, which, for the purpose of SUMMARY: The Copyright Office implementing an online registration published in the Federal Register on system, amended its regulations July 6, 2007, an interim regulation governing the procedures by which the implementing an online copyright public submits, and the Office registration system. This document processes, copyright registrations and

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