[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
