Date="03/17/94" Citation="59 FR 12562" Group="legal" Type="PROPOSED RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA), JUSTICE" Subject="Elimination of Threshold for Ephedrine"

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1310 Elimination of Threshold for Ephedrine AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Proposed rule.

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1310 Elimination of Threshold for Ephedrine AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Proposed rule. + ------------------------------------------------------------ SUMMARY: The DEA proposes to eliminate the threshold for ephedrine under provisions of the Chemical Diversion and Trafficking Act of 1988 (CDTA) in order to reduce the diversion of ephedrine to clandestine laboratory operators. This would subject all transactions involving bulk ephedrine and single entity ephedrine drug products to the applicable provisions of the Controlled Substances Act (CSA). DATES: Written comments and objections must be received on or before May 2, 1994. ADDRESSES: Comments and objections should be submitted in quintuplicate to the Administrator, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/CCR. FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537 Telephone (202) 307-7183. SUPPLEMENTARY INFORMATION: Ephedrine is the primary precursor utilized in the clandestine synthesis of methamphetamine and methcathinone, both potent central nervous system (CNS) stimulants controlled under the CSA. The public health risks from the abuse of these drugs are well known and documented. Ephedrine is a listed chemical under the Chemical Diversion and Trafficking Act of 1988 (CDTA) (Pub. L. 100-690). Under provisions of the CDTA (21 U.S.C. 802(34)(c)), thresholds were originally assigned to each listed chemical. The CDTA imposes reporting and recordkeeping requirements for regulated transactions which meet or exceed these threshold amounts of a listed chemical. The Domestic Chemical Diversion Control Act (DCDCA) of 1993 (Pub. L. 103-200) was recently enacted and will become effective on April 16, 1994. This Act amends the CSA to permit that no threshold be established for a listed chemical via modification of 21 U.S.C. 802(39)(A) by redefining the term "regulated transaction'' as a "distribution, receipt, sale, importation, or exportation, or an international transaction involving shipment of a listed chemical, or if the Attorney General establishes a threshold amount for a specific listed chemical, a threshold amount, including a cumulative threshold amount for multiple transactions'' of a listed chemical. By not establishing a threshold for a listed chemical, all regulated transactions regardless of size are subject to CDTA reporting and recordkeeping requirements. In addition, the DCDCA further modifies the definition of a "regulated transaction'' by removing the exemption of those transactions involving products which are marketed or distributed lawfully in the U.S. under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), if these products contain ephedrine or its salts, optical isomers, or salts of optical isomers as the only active medicinal ingredient or contain ephedrine in combination with therapeutically insignificant quantities of another active medicinal ingredient (21 U.S.C. 802(39)(A)(iv)). The DCDCA also provides that the Attorney General shall by regulation remove this exemption for drug products that the Attorney General finds are being diverted in order to obtain a listed chemical for use in the illicit production of a controlled substance. The threshold for ephedrine was originally established as 1.0 kilogram for domestic and import/export transactions, after internal study and industry consultation (54 FR 31657). The threshold of 1.0 kilogram of ephedrine base is equivalent to greater than 48,000 ephedrine 25 mg tablets or capsules. Thresholds are continuously reviewed by DEA to determine if they are satisfactory to prevent diversion without overburdening industry. Current evidence indicates that the threshold for ephedrine of 1.0 kilogram is not adequate to prevent the diversion of ephedrine to clandestine laboratory operators. Clandestine laboratory operators are obtaining and utilizing ephedrine in quantities much less than the current 1.0 kilogram threshold in the illicit production of methamphetamine and methcathinone. The DEA has determined that in order to ensure the maximum effectiveness of the CDTA in curtailing the diversion of ephedrine, there should be no threshold for ephedrine. Subsequently, all regulated transactions of ephedrine are subject to reporting and recordkeeping requirements of the CDTA regardless of size. While seizures of clandestine methamphetamine laboratories have decreased significantly since the passage of the CDTA, more than 1200 methamphetaime laboratories have been seized in the United States since 1990. The majority of these laboratories utilized ephedrine as the precursor. In 1992, greater than 68 percent of the methamphetamine laboratories seized utilized ephedrine. A preliminary review of 1993 methamphetamine laboratory seizure data indicates that ephedrine was the precursor utilized in approximately 75 percent of these laboratories. In addition to its use as the preferred precursor for the production of methamphetamine, ephedrine is also utilized in the synthesis of methcathinone. The clandestine manufacture of methcathinone, a methamphetamine analogue known on the street as "Cat'', has been identified in the U.S. since 1991, when five laboratories were seized. Methcathinone was temporarily placed in Schedule I on May 1, 1992, pursuant to the emergency scheduling provisions of the CSA (21 U.S.C. 811(h)). Effective October 15, 1993, methcathinone was permanently controlled in Schedule I (58 FR 53404). Methcathinone (N-methylcathinone) is manufactured in clandestine laboratories via the oxidation of ephedrine. Since June of 1991, all clandestine methcathinone laboratories seized utilized ephedrine as the precursor. These laboratories were located in Indiana, Illinois, Michigan, Washington and Wisconsin. The number of methcathinone laboratory seizures continues to grow from six in 1992 to 21 laboratories in 1993. Methcathinone is usually produced in small batches. Seizures of illicit methcathinone laboratories indicate that batch sizes routinely utilize less than 20 grams of ephedrine. The vast majority of this ephedrine is obtained via the purchase of over- the-counter (OTC) ephedrine 25 mg tablets sold in bottles of 1000 dosage units or less. Batch sizes of methamphetamine produced at clandestine labs can vary greatly. Recent information indicates that methamphetamine is also produced in small batches via a procedure known as the "cold process.'' This procedure has utilized quantities of 40 grams or less of ephedrine. The smuggling of bulk ephedrine and the purchase of OTC ephedrine tablets are the primary sources of ephedrine utilized at these clandestine laboratories. Ephedrine tablets make up a significant portion of the more than 10 metric tons of ephedrine reportedly seized at clandestine laboratories between 1990 and 1992. This material may be purchased from several different sources at below threshold quantities. The purchase of regulated chemicals from several suppliers in quantities below established thresholds is a common method of diversion and continues to occur with ephedrine. A comparison of U.S. hospital/pharmacy purchase data with the quantities of ephedrine seized at clandestine laboratories indicates that the use of ephedrine for clandestine laboratories is much greater than amounts purchased by these types of distribution outlets. Drug products containing ephedrine are used legitimately to treat asthma and other conditions. They are available as OTC products from pharmacies, hospitals and other distribution outlets. Ephedrine products, which are lawfully marketed and distributed under the Federal Food Drug and Cosmetic Act and contain other active medicinal ingredients in therapeutically significant concentrations, are currently exempt from the reporting and recordkeeping requirements imposed under the CDTA. Of the oral OTC products available for medicinal treatment of chronic asthma, these ephedrine combination products are the products more frequently dispensed by pharmacies and hospitals. The elimination of a threshold for ephedrine does not impose any additional requirements on pharmacies, hospitals or points of distribution which distribute only those ephedrine products which are exempted. The Acting Administrator, Drug Enforcement Administration, hereby certifies that this proposed rulemaking will have no significant impact upon entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This proposed rule only eliminates the existing threshold for which ephedrine transactions must be reported and records maintained. It only impacts firms involved with small bulk transfers of ephedrine or distribution of single entity ephedrine tablets/capsules. This proposed rule is not a significant regulatory action and therefore need not be reviewed by the Office of Management and Budget pursuant to Executive Order 12866. This action has been analyzed in accordance with the principles and criteria in E.O. 12612, and it has been determined that the proposed rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. List of Subjects in 21 CFR 1310 Drug Enforcement Administration, Drug traffic control, Reporting and recordkeeping requirements. For reasons as set out above, 21 CFR part 1310 is proposed to be amended as follows: PART 1310-[AMENDED] 1. The authority citation for part 1310 continues to read as follows: Authority: 21 U.S.C. 802, 830, 871(b). 2. Section 1310.04 is proposed to be amended by revising the introductory text to paragraph (f); removing paragraph (f)(1)(iii); redesignating paragraphs (f)(1)(iv) through (f)(1)(xxiv) as (f)(1)(iii) through (f)(1)(xxiii) respectively; and adding a new paragraph (g) to read as follows: sec 1310.04 Maintenance of records. * * * * * (f) For those listed chemicals for which thresholds have been established, the quantitative threshold or the cumulative amount for multiple transactions within a calendar month, to be utilized in determining whether a receipt, sale, importation or exportation is a regulated transaction is as follows: * * * * * (g) For listed chemicals for which no thresholds have been established, the size of the transaction is not a factor in determining whether the transaction meets the definition of a regulated transaction as set forth in sec 1310.01(f). All such transactions, regardless of size, are subject to recordkeeping and reporting requirements as set forth in part 1310. (1) Listed Chemicals For Which No Thresholds Have Been Established: (i) Ephedrine, its salts, optical isomers, and salts of optical isomers (ii) [Reserved] (2) [Reserved] Dated: February 28, 1994. Stephen H. Greene, Acting Administrator of Drug Enforcement. [FR Doc. 94-6234 Filed 3-16-94; 8:45 am] BILLING CODE 4410-09-M ------------------------------------------------------ The Contents entry for this article reads as follows: Chemical Diversion and Trafficking Act of 1988; implementation: Ephedrine; threshold elimination, 12562