[Federal Register Volume 59, Number 52 (Thursday, March 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6234]


[[Page Unknown]]

[Federal Register: March 17, 1994]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

 

Elimination of Threshold for Ephedrine

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Proposed rule.

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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