[Federal Register Volume 62, Number 189 (Tuesday, September 30, 1997)]
[Proposed Rules]
[Pages 51072-51074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25362]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[DEA-156P]
RIN #1117-aa43
Listed Chemicals; Proposed Establishment of Thresholds for Iodine
and Hydrochloric Gas (Hydrogen Chloride Gas)
agency: Drug Enforcement Administration (DEA), Justice.
action: Notice of proposed rulemaking.
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summary: The Comprehensive Methamphetamine Control Act of 1996 (MCA)
establishes that, effective October 3, 1996, iodine and hydrogen
chloride gas are List II chemicals under the Controlled Substances Act
(CSA). The inclusion of these chemicals under the CSA requires that
each regulated person must keep records and file reports as specified
in Title 21 Code Federal Regulations (21 CFR) Part 1310. Since the MCA
did not establish thresholds for iodine and hydrogen chloride gas,
recordkeeping and reporting requirements became applicable to all
domestic transactions of these chemicals. While this notice of proposed
rulemaking is proposing a domestic threshold of 0.0 kilograms for
hydrogen chloride gas, it proposes to set a domestic threshold of 0.4
kilograms for iodine. This iodine threshold will remove the
recordkeeping requirement for many iodine transactions.
This notice of proposed rulemaking also proposes to reinsert the
table in 21 CFR 1310.04(f)(2)(iv), listing thresholds for exports,
transshipments, and international transactions to designated countries
set forth in 1310.08(b). The DEA's final rule regarding implementation
of the Domestic Chemical Diversion Control Act of 1993, published on
June 22, 1995 [60 FR 32447] inadvertently omitted the table from the
section.
dates: Written comments or objections must be received on or before
December 1, 1997.
addresses: Comments and objections should be submitted in quintuplicate
to the Deputy Assistant Administrator, Office of Diversion Control,
Drug Enforcement Administration, Washington, D.C. 20537, Attention: DEA
Federal Register Representative/CCR.
for further information contact: Frank Sapienza, Chief, Drug and
Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, Washington, D.C. 20537, Telephone (202)
307-7183.
supplementary information: The MCA was signed into law on October 3,
1996, Section 204 of the MCA amends Section 102(35) of the CSA (21
U.S.C. 802(35)) to include iodine and hydrogen chloride gas as List II
chemicals. Section 204(b) (1) and (2) of the MCA also states that
``iodine shall not be subject to the requirements for listed chemicals
provided in section 1018 of the Controlled Substances Import and Export
Act (21 U.S.C. 971).'' Therefore, the MCA does not impose import/export
requirements on iodine. The MCA, however, does not ``limit the
authority of the Attorney General to impose the requirements for listed
chemicals provided in section 1018 of the Controlled Substances Import
and Export Act (21 U.S.C. 971).'' Although the DEA is not imposing
import/export restrictions on iodine at this time, the DEA is currently
reviewing available data on iodine to determine if such controls are
warranted.
Prior to the MCA, hydrogen chloride gas, also known as anhydrous
hydrochloric acid, was already a List II chemical under the CSA (21 CFR
1310.02(b)(8)). Pursuant to 21 CFR 1310.08, all domestic and import
transactions of hydrogen chloride gas have been exempt from the
regulatory controls under the CSA. In addition, all exports,
transshipments and international transactions of hydrogen chloride gas
have been exempt from the regulatory controls except those to all South
American countries and Panama. Exports to all South American countries
and Panama above a threshold of 27 kilograms have been regulated
transactions (21 CFR 1310.08(b)). The MCA amends the CSA to impose only
domestic controls on iodine and domestic and international controls on
hydrogen chloride gas.
The majority of the clandestine laboratories seized in the United
States manufacture methamphetamine, a Schedule II controlled substance.
Since 1990, more than 2,400 methamphetamine laboratories have been
seized in the United States by the DEA. The most frequently used
synthesis among clandestine laboratory operators today is the
ephedrine/pseudoephedrine reduction method which utilizes hydriodic
acid. Hydriodic acid is a List I chemical with a domestic threshold of
one liter. With the increased controls on hydriodic acid, clandestine
laboratory operators have turned to producing their own hydriodic acid
or using iodine directly in the synthesis. Clandestine laboratory
[[Page 51073]]
operators, since 1992, have been utilizing iodine either directly in
the ephedrine/pseudoephedrine reduction method or have been using
iodine to produce hydriodic acid, the traditional reducing agent in the
ephedrine/pseudoephedrine reduction method. Hydrogen chloride gas, on
the other hand, can be used in the clandestine synthesis of most
controlled substances to convert the basic form of a controlled
substance to its hydrochloride salt. It is often used in the illicit
production of methamphetamine.
Certain provisions of the CSA and its regulations are applicable
only to regulated transactions involving listed chemicals. For purposes
of defining a regulated transaction (21 U.S.C. 802(39)), the CSA
provides that the Attorney General may impose a threshold amount for
each listed chemical. A threshold amount is established to determine
whether a receipt, sale, importation or exportation within a calendar
month or multiple transactions by an individual within a calendar month
are considered regulated transactions. If the transaction is considered
a regulated transaction, then they are recordkeeping and reporting
requirements as specified in 21 CFR 1310.
The DEA examined several types of information in proposing a
domestic threshold for iodine: legitimate use in industry, including
the quantities normally required for such uses; quantities purchased by
clandestine laboratory operators; quantities seized at clandestine
laboratory sites; and its use in the production of methamphetamine. The
number of clandestine laboratories using iodine in the synthesis of
methamphetamine has increased drastically in the past five years. In
1992, the DEA documented that 18 of the 228 (approximately 6 percent)
methamphetamine clandestine laboratories seized by DEA used iodine.
During 1996, at least 290 methamphetamine clandestine laboratories
seized by DEA used iodine. The majority of these clandestine
laboratories are producing small quantities (i.e., less than one-half
kilogram) of methamphetamine. Seizures of iodine at the clandestine
laboratory sites ranged from approximately 10 grams to 3,000 kilograms.
The DEA cannot determined the source of all of the iodine seized at
clandestine laboratory sites due to clandestine laboratory operators
removing the original labels or transferring the iodine to other
unmarked containers. At those sites where iodine was seized in its
original containers, DEA identified that the iodine was being purchased
from either veterinary supply stores, feed and tack/farm supply stores
or chemical distributors.
The DEA sought information from legitimate handlers of iodine
(i.e., manufacturers, end-users, distributors, and veterinary, feed and
farm supply stores/companies) to determine the uses of iodine and the
quantities typically found in legitimate transactions. Of particular
interest to DEA was the sale of relatively small quantities of iodine
for cauterization of a hoof wound and for the treatment of thrush. The
DEA sought information from over 300 veterinary suppliers and feed and
farm supply stores to determine if the stores sold iodine. Of the 300
stores and suppliers which provided information, only nine sold iodine.
Several suppliers and end-users stated that a two-ounce bottle of
iodine would last a rancher or a farrier several months and that,
typically, an individual would purchase at the most 3-2 ounce bottles
(approximately 0.2 kilograms) at a time.
Based on this information, the DEA is proposing a domestic
threshold of 0.4 kg for iodine. This would ensure the most effective
controls on the diversion of iodine while minimizing the impact on
industry, particularly for small businesses such as veterinary, feed,
and farm supply stores.
The proposed domestic threshold of hydrogen chloride gas is based
upon several items: its legitimate use in industry; quantities used by
legitimate industry; and quantities of hydrogen chloride gas seized at
clandestine laboratories.
Hydrogen chloride gas is sold in cylinders. Traditionally,
cylinders of hydrogen chloride gas have been seen mostly at
methamphetamine clandestine laboratory sites in the western part of the
United States. Most of the cylinders seized at the clandestine
laboratory sites contain approximately 60 pounds of hydrogen chloride
gas. Small cylinders which contain 0.5 pounds of hydrogen chloride gas
have also been seen at some laboratory sites.
The DEA gathered information on the legitimate uses of hydrogen
chloride gas in the United States. The major uses of hydrogen chloride
gas were determined to be in the cotton industry, the electronic/
silicon industry, the pharmaceutical industry and other industries for
use in chemical syntheses. All of these industries use large quantities
of hydrogen chloride gas for their manufacturing processes. Generally,
thousands of pounds are involved in single transactions with the
exception of smaller quantities (i.e., single or multiple cylinders)
being used by research, analytical or synthetic laboratories. There are
also safety issues regarding the handling of hydrogen chloride gas.
Since the majority of hydrogen chloride gas transactions involve
thousands of pounds and to ensure the most effective controls on the
diversion of hydrogen chloride gas, the DEA proposes a domestic
threshold of 0 kg for hydrogen chloride gas. A threshold of 0 kg means
that all sales of hydrogen chloride gas would be regulated.
Before the MCA was passed, hydrogen chloride gas, also known as
anhydrous hydochloric acid, was already a List II chemical under the
CSA (21 CFR 1310.02(b)(8)). All domestic and import transactions, and
exports, transshipments and international transactions, except those to
all South American countries and Panama, have been exempt from
regulatory controls under the CSA. Exports, transshipments and
international transactions of hydrogen chloride gas to all South
American countries and Panama above a threshold of 27 kilograms have
been regulated transactions pursuant to 21 CFR 1310.08(b). These
transactions became regulated due to the DEA having evidence that
hydrogen chloride gas was being diverted from illicit channels to
illicit channels for cocaine hydrochloride production in these
countries. With the passage of the MCA, both domestic and international
controls apply to hydrogen chloride gas.
The DEA is also including in this proposed Federal Register notice
the reinsertion of the table in 21 CFR 1310.04(f)(2)(iv), listing
thresholds for exports, transshipments, and international transactions
to designated countries set forth in 1310.08(b). The DEA's final rule
regarding implementation of the Domestic Chemical Diversion Control Act
of 1993, published on June 22, 1995 [60 FR 32447] inadvertently omitted
the table from the section.
The Deputy Assistant Administrator of DEA's Office of Diversion
Control 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. Controls on
iodine apply to iodine crystals. These controls do not pertain to
common household products such as iodine tinctures of iodide salts. The
proposed iodine rulemaking applies only to those companies
manufacturing and distributing iodine in larger volumes. Recordkeeping
requirements will not impact researchers or other end-users. Further,
this proposed rule is not a significant regulatory action
[[Page 51074]]
pursuant to the criteria of Executive Order 12866, since the 0.4 kg
iodine threshold does not affect small businesses and since there is
not a large industry for hydrogen chloride gas. Therefore, this
proposed rule has not been reviewed by the Office of Management and
Budget.
This action has been analyzed in accordance with the principles and
criteria in Executive Order 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 Part 1310
Drug traffic control, Reporting and recordkeeping requirements.
For reasons 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 1310.02 is proposed to be amended by revising paragraph
(b)(8) and adding paragraph (b)(11) to read as follows:
Sec. 1310.02 Substances covered.
* * * * *
(b) List II chemicals:
* * * * *
(8) Hydrochloric acid (Including Hydrogen chloride gas)
* * * * *
(11) Iodine
* * * * *
3. Section 1310.04 is proposed to be amended by adding new
paragraphs (f)(2)(ii) (H) and (I), and revising (f)(2)(iv) to read as
follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(f) * * *
(2) * * *
(i) * * *
(ii) Domestic Sales
------------------------------------------------------------------------
Threshold by
Chemical volume Threshold by weight
------------------------------------------------------------------------
* * * * *
(H) Iodine.................... N/A.............. 0.4 kilograms.
(I) Hydrogen chloride gas..... N/A.............. 0.0 kilograms.
------------------------------------------------------------------------
(iii) * * *
(iv) Exports, Transshipments and International Transactions to
Designated Countries As Set Forth in Sec. 1310.08(b).
------------------------------------------------------------------------
Threshold by
Chemical volume Threshold by weight
------------------------------------------------------------------------
(A) Hydrochloric acid......... 50 gallons....... N/A.
(1) Hydrogen chloride gas..... N/A.............. 27 kilograms.
(B) Sulfuric acid............. 50 gallons....... N/A.
------------------------------------------------------------------------
* * * * *
4. Section 1310.08 is proposed to be amended by adding new
paragraphs (f) and (g) to read as follows:
Sec. 1310.08 Excluded transactions
* * * * *
(f) Import and export transactions of iodine.
(g) Import transactions of hydrogen chloride gas.
Dated: July 21, 1997.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 97-25362 Filed 9-29-97; 8:45 am]
BILLING CODE 4410-09-M