[Federal Register: August 11, 2006 (Volume 71, Number 155)]
[Proposed Rules]
[Page 46144-46155]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11au06-24]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-257P]
RIN 1117-AA93
Changes in the Regulation of Iodine Crystals and Chemical
Mixtures Containing Over 2.2 Percent Iodine
AGENCY: Drug Enforcement Administration (DEA), U.S. Department of
Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: This Notice of Proposed Rulemaking (NPRM) proposes changes in
the regulation of the listed chemical iodine pursuant to the chemical
regulatory provisions of the Controlled Substances Act (CSA). The Drug
Enforcement Administration (DEA) believes that this action is necessary
in order to remove deficiencies in the current regulatory controls,
which are being exploited by drug traffickers who divert iodine (in the
form of iodine crystals and iodine tincture) for the illicit production
of methamphetamine in clandestine drug laboratories. This NPRM proposes
(1) the movement of
[[Page 46145]]
iodine from List II to List I; (2) a reduction in the iodine threshold
from 0.4 kilograms to zero kilograms; (3) the addition of import and
export regulatory controls; and (4) the control of chemical mixtures
containing greater than 2.2 percent iodine.
This NPRM proposes regulatory controls that will apply to iodine
crystals and iodine chemical mixtures that contain greater than 2.2
percent iodine. This regulation will therefore control iodine crystals
and strong iodine tinctures/solutions (e.g., 7 percent iodine) that do
not have common household uses and instead have limited application in
livestock, horses and for disinfection of equipment. Household products
such as 2 percent iodine tincture/solution and household disinfectants
containing iodine complexes will not be adversely impacted by this
regulation.
If finalized as proposed, persons conducting regulated transactions
involving iodine would need to be registered with the DEA, would be
subject to import/export notification requirements of the CSA, and
would be required to maintain records of all regulated transactions
involving iodine regardless of size.
DATES: Written comments must be postmarked, and electronic comments
must be sent, on or before October 10, 2006.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-257P'' on all written and electronic correspondence.
Written comments via regular mail should be sent to the Deputy
Administrator, Drug Enforcement Administration, Washington, DC 20537,
Attention: DEA Federal Register Representative/ODL. Written comments
sent via express mail should be sent to DEA Headquarters, Attention:
DEA Federal Register Representative/ODL, 2401 Jefferson-Davis Highway,
Alexandria, VA 22301. Comments may be sent directly to DEA
electronically by sending an electronic message to
dea.diversion.policy@usdoj.gov. Comments may also be sent
electronically through http://www.regulations.gov using the electronic
comment form provided on that site. An electronic copy of this document
is also available at the http://www.regulations.gov Web site. DEA will
accept attachments to electronic comments in Microsoft Word,
WordPerfect, Adobe PDF, or Excel file formats. DEA will not accept any
file format other than those specifically listed here.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537 at (202) 307-7183.
SUPPLEMENTARY INFORMATION:
I. Background Information on Iodine
Congress placed iodine in List II by amending Section 102(35) of
the CSA (21 U.S.C. 802(35)) by passage of Public Law 104-237, the
Comprehensive Methamphetamine Control Act of 1996 (MCA) on October 3,
1996. Iodine became a regulated chemical because of its use in the
clandestine manufacture of the Schedule II controlled substances
amphetamine and methamphetamine. Methamphetamine is the leading
clandestinely manufactured controlled substance in the United States.
Faced with the growing threat of methamphetamine abuse in the
United States and the ease with which methamphetamine is clandestinely
produced using iodine, the DEA is proposing to increase the regulatory
controls on iodine in an effort to prevent the diversion of iodine to
clandestine drug laboratories.
Legitimate Uses of Iodine
Iodine is important to the chemical and allied industries primarily
as a chemical intermediate used to make new chemical products for
industry and research. These products have application in sanitation
(as disinfectants), animal feed, pharmaceuticals, as catalysts, heat
stabilizers, and in various other industrial applications. Most iodine
is consumed by industry. Those who purchase iodine for end use, whether
they are individuals or businesses, would be subject to CSA chemical
regulatory controls to the extent that they must present identification
and provide other information that helps assure the seller that his or
her proposed use of the chemical is legitimate. See 21 U.S.C. 830 and
21 CFR 1310.07.
Iodine has powerful bactericidal action and is used for
disinfecting unbroken skin before surgery. Iodine also may be employed
as a weak solution for the first-aid treatment of small wounds and
abrasions.
The standard definition for iodine topical solutions, and other
iodine containing products, is specified in the United States
Pharmacopeia (U.S.P.). The U.S.P. lists two strengths of iodine
solution and two strengths of iodine tincture. The U.S.P. specifies
formulations for iodine topical solution, strong iodine solution,
iodine tincture, and strong iodine tincture in the official monographs.
Commercially available iodine solutions and tinctures are
summarized in the following table:
Concentration of Iodine Products Per 100 ml
----------------------------------------------------------------------------------------------------------------
Sodium Iodide Potassium
Iodine (gm.) (gm.) Iodide (gm.)
----------------------------------------------------------------------------------------------------------------
Iodine Topical (w/ water)....................................... 1.8-2.2 2.1-2.6 ..............
Strong Iodine (w/ water)........................................ 4.5-5.5 .............. 9.5-10.5
----------------------------------------------------------------------------------------------------------------
As shown on the table, the solutions are formulated in two
concentrations of iodine. They are specifically named as iodine topical
solution and strong iodine solution. Iodine topical solution two
percent U.S.P. is defined as having in each 100 ml, not less than 1.8
grams and not more than 2.2 grams of iodine, and not less than 2.1
grams and not more than 2.6 grams of sodium iodide. Only water is used
as the solvent. Strong iodine solution U.S.P. contains in each 100 ml,
not less than 4.5 grams and not more than 5.5 grams of iodine and not
less than 9.5 grams and not more than 10.5 grams of potassium iodine.
The U.S.P. defines iodine tincture as containing, in each 100 ml,
not less than 1.8 grams and not more than 2.2 grams of iodine, and not
less than 2.1 grams and not more than 2.6 grams of sodium iodide. The
same weight amounts of iodine and sodium iodide are used as in the
iodine topical solution except that alcohol is used in 44 to 50 percent
[[Page 46146]]
concentration. The target concentration of iodine is 2 percent. Strong
iodine tincture is defined as containing, in each 100 ml, not less than
6.8 grams and not more than 7.5 grams of iodine and not less than 4.7
grams and not more than 5.5 grams of potassium iodide. The alcohol
content is between 82.5 and 88.5 percent. The target iodine
concentration is 7 percent.
Iodine two percent tincture and solution U.S.P. are sold at a wide
variety of retail outlets and have household application as antiseptic
and antimicrobial products. These products will not become regulated
under the proposed regulation. In contrast, however, iodine crystals
and iodine chemical mixtures containing over 2.2 percent iodine have no
household use and are available only from specialty retailers. Iodine
solutions (in excess of 2.2 percent iodine) are used as an antiseptic
in the care of livestock and horses and as disinfectants for equipment
and areas where livestock are kept. Some iodine solutions are used in
saltwater aquariums, to test for the presence of starch, and as stains
in some laboratory tests. This NPRM proposes regulating these chemical
mixtures, but provides for the possibility of exemption as discussed
later in this rule.
Iodine crystals have also been historically used by campers to
purify water. Today, however, most of the water treatment products
available to campers utilize iodide salts and are not the subject of
this regulation. DEA, however, has identified two marketed products
that contain iodine for water purification. Under this NPRM, these
products would be subject to control.
There are other iodine containing products that have household use
and are widely sold in retail settings. Iodine products classified as
iodophors consist of iodine complexed with surfactant compounds (e.g.
poloxamer-iodine complex) or with nonsurfactant compounds (e.g.
polyvinyl pyrrolidone-iodine complex (povidone-iodine)). These
complexes allow the iodine to be continually delivered. Such complex
solutions in water or alcohol are better tolerated than iodine tincture
and solutions with comparable efficacy. Considering the necessary time
of application and the correct dilution, these complexes are used for
general disinfection, hand disinfection, as well as for skin
disinfection prior to surgery or venipuncture. Some of these iodine
complexes are also used for the treatment of burns and of different
skin lesions. Since these complex products do not have applicability as
a source of iodine at clandestine drug laboratories, DEA is proposing
that these products be specifically exempted in 21 CFR 1310.12(d)(4).
This provision would be automatically exempt from CSA controls ``Iodine
products classified as iodophors which exist as an iodine complex to
include poloxamer-iodine complex, polyvinyl pyrrolidone-iodine complex
(i.e. povidone-iodine), undecoylium chloride iodine, nonylphenoxypoly
(ethyleneoxy) ethanol-iodine complex, iodine complex with phosphate
ester of alkylaryloxy polyethylene glycol, and iodine complex with
ammonium ether sulfate/polyoxyethylene sorbitan monolaurate.''
DEA is aware that the element iodine is a constituent in certain
pharmaceutical products (e.g. potassium iodide and others) sold over-
the-counter or pursuant to a prescription. Potassium iodide is
available for use in the event of a nuclear incident to protect the
thyroid gland of exposed individuals. The element iodine is also a
constituent in products sold as radioisotopes (e.g. radioactive iodine)
which find widest use in the treatment of hyperthyroidism and in the
diagnosis of certain disorders (e.g. thyroid dysfunction). The greatest
use has been made of sodium iodide I\131\. DEA is also aware of other
radiolabeled material, such as sodium iodide I\123\, which is available
for scanning/imaging purposes in disease diagnosis. Note that these
iodide compounds are not the subject of this NPRM. As such, the
proposed regulatory controls will not apply to any of these iodide
salts or radiolabeled iodine. Additionally, these proposed regulatory
controls will not apply to any iodide material commonly dispensed
pursuant to a prescription. Instead, this NPRM is limited only to the
regulation of iodine crystals and chemical mixtures that contain iodine
in the form of the iodine tinctures and iodine solutions described
above.
This NPRM proposes regulatory controls that will apply to iodine
crystals and iodine chemical mixtures that contain greater than 2.2
percent iodine. The vast majority of products having household
application will not be adversely impacted by this regulation.
Why Traffickers Use Iodine
Due to the regulatory controls placed on the listed chemical
hydriodic acid, drug traffickers began using iodine as a substitute
chemical in the illicit production of methamphetamine and amphetamine,
both Schedule II controlled substances. Hydriodic acid became a
regulated chemical upon enactment of the Chemical Diversion and
Trafficking Act of 1988 (Pub. L. 100-690). Hydriodic acid, like iodine,
was initially regulated as a List II chemical. Hydriodic acid was
reclassified as a List I chemical by enactment of the Crime Control Act
of 1990 (Pub. L. 101-647).
The Domestic Chemical Diversion Control Act of 1993 (DCDCA) (Pub.
L. 103-200) required that handlers of List I chemicals be registered.
This increased regulatory control and made it more difficult for
traffickers to acquire hydriodic acid. Faced with this difficulty,
traffickers began to substitute iodine for hydriodic acid for the
illicit production of methamphetamine and amphetamine.
Iodine is commonly used with the List I chemicals phosphorus or
hypophosphorous acid and ephedrine or pseudoephedrine to manufacture
methamphetamine, which is now the most prevalent method used by
traffickers. The List I chemicals phenylpropanolamine or
norpseudoephedrine can be made into amphetamine by the same method.
Current Regulatory Controls on Iodine and Need for Increased Regulation
In response to the increased use of iodine in clandestine drug
laboratories, Congress controlled iodine as a List II chemical by
amending Section 102(35) of the CSA (21 U.S.C. 802(35)) by passage of
Public Law 104-237, the Comprehensive Methamphetamine Control Act of
1996 (MCA) on October 3, 1996.
Although iodine became subject to CSA chemical regulatory controls,
traffickers have exploited certain deficiencies in these controls to
divert iodine. Only certain domestic distributions are regulated
transactions, and distributions below the 0.4 kilogram cumulative
threshold (about one pound), within a calendar month, are not regarded
as regulated transactions. Import and export transactions of iodine are
not regulated, regardless of the quantity distributed. Additionally,
because iodine is a List II chemical, handlers of iodine are not
required to register with DEA. These loopholes have been exploited by
drug traffickers and the businesses that supply them.
While the regulatory controls placed on iodine apply to iodine
crystals, they have not pertained to iodine tinctures (which are
considered chemical mixtures). Drug traffickers are currently
circumventing CSA regulatory controls via the diversion of iodine
tinctures. Traffickers have learned that the tinctures can serve as a
ready source of iodine crystals when the tincture is subjected to the
appropriate chemical reaction.
[[Page 46147]]
Existing regulations pertaining to iodine have proved to be
inadequate to prevent diversion. Traffickers have been able to make
undocumented purchases of iodine crystals (up to the existing threshold
of 0.4 kilograms), make unlimited purchases of iodine tincture, and
make undocumented import and export shipments of iodine. Additionally,
because iodine is a List II chemical and distributors are not
registered, it is difficult for DEA to identify all handlers of
regulated material.
This NPRM proposes changes to the regulatory control of iodine in
an effort to prevent the diversion of iodine for the illicit production
of methamphetamine and amphetamine.
Use of Iodine in Clandestine Drug Laboratories
Iodine is a major chemical used in the illicit manufacture of
methamphetamine and amphetamine. DEA's El Paso Intelligence Center
(EPIC) maintains the official U.S. database of clandestine laboratories
seized by Federal, State, and local law enforcement. As reported by
EPIC, the number of clandestine methamphetamine laboratories using
iodine was 2243, 2774, 4015, 4326, and 4904 for the calendar years
1999, 2000, 2001, 2002, and 2003, respectively. The number of
laboratories reported to have used hydriodic acid over the same years
was 644, 661, 735, 746, and 650, respectively. The increased use of
iodine over hydriodic acid is seen going back to 1997, the earliest
year that such information is available from EPIC's database.
The data for clandestine labs seized only by federal authorities
show similar trends. STRIDE (System to Retrieve Information on Drug
Evidence) is a DEA maintained database that includes reports of
clandestine laboratory seizures made primarily by DEA. STRIDE reports
that between 1990 and 1994, the number of clandestine laboratories that
used hydriodic acid was much greater than those using iodine. Although
hydriodic acid became a List I chemical in 1990, handlers were not
required to register until 1993. By 1994, the number of DEA cases
involving iodine surpassed the number for hydriodic acid, and this has
continued to the present time. This trend indicates that regulatory
controls governing the handling of hydriodic acid were effective in
causing traffickers to seek an alternate to hydriodic acid, in the form
of iodine, which had less stringent regulatory controls.
Commercial iodine chemical mixtures, reported as iodine tincture,
have also been identified as significant sources of iodine in
clandestine methamphetamine laboratories. The number of iodine tincture
seizures reported by EPIC has steadily increased from 71 seizures in
calendar year 1999, 397 seizures in calendar year 2000, 1154 seizures
in calendar year 2001, 1679 seizures in calendar year 2002, to 2252
seizures in calendar year 2003. Thus, iodine and iodine tincture have
increasingly been used as chemicals in the illicit production of
controlled substances within the United States.
International Scope of Problem
The illicit production of methamphetamine is also an international
problem. Mexican drug trafficking organizations operating out of Mexico
and California began to dominate the illicit production and
distribution of methamphetamine in the United States around 1994. This
followed years of control by independent, regional outlaw motorcycle
gangs, supplemented by numerous independent, smaller-scale producers.
Mexican organizations now produce and supply the majority of the
methamphetamine illicitly available in the United States, using large-
scale laboratories based in Mexico and the Southwestern United States.
Outlaw motorcycle gangs and small independent producers remain active
in domestic methamphetamine production, but not on the same scale as
the Mexican traffickers. The Mexican organizations' ready access to
essential chemicals on the international market has greatly facilitated
their ability to produce large amounts of methamphetamine.
Seizures along the Mexican border illustrate the need for import/
export control of iodine. The United States Bureau of Immigration and
Customs Enforcement (ICE) reports seizures at Southern California ports
of entry. In Calendar Year 2001, ICE reported that there were 26
seizures of iodine totaling 2140 kilograms. In Calendar Year 2002,
there were 20 seizures totaling 1605 kilograms, and in Calendar Year
2003, there were 19 seizures totaling 971 kilograms. The smuggling of
iodine illustrates the need for additional international controls.
Although iodine seizures have been declining, these quantities remain
significant. The decrease may reflect a changing pattern of production
by large methamphetamine manufacturing organizations, which have
shifted some production, via large capacity clandestine labs, from
California to Mexico.
II. Proposed Changes to the Regulation of Iodine
Moving Iodine Into 21 CFR 1310.02(a) (List I)
The Controlled Substances Act (CSA) and its implementing
regulations, specifically 21 U.S.C. 802(35) and 21 CFR 1310.02(c),
provide the Attorney General with the authority to specify, by
regulation, the addition or deletion of any chemicals as listed
chemicals if they are used in the manufacture of a controlled substance
in violation of the CSA. This authority has been delegated to the
Administrator of DEA by 28 CFR 0.100 and redelegated to the Deputy
Administrator by 28 CFR 0.104 Appendix to Subpart R Section 12.
The definition in 21 CFR 1300.02 (b)(19), defines ``List II
chemical'' as a chemical, other than a List I chemical, specifically
designated by the Administrator in 21 CFR 1310.02(b), that ``is used in
manufacturing a controlled substance in violation of the Act.'' 21 CFR
1300.02(b)(18) defines the term ``List I chemical'' to mean ``a
chemical specifically designated by the Administrator in 21 CFR
1310.02(a) * * * that * * * is used in manufacturing a controlled
substance in violation of the Act and is important to the manufacture
of a controlled substance.''
The DEA is proposing to remove iodine from 21 CFR 1310.02(b) (List
II) and to place it in 1310.02(a) (List I) because, based on the
information provided above, iodine is a chemical that is important to
the manufacture of the controlled substances methamphetamine and
amphetamine. If placed in List I, 21 U.S.C. 822(a)(1) requires that
persons who distribute iodine must be registered with DEA. Based on its
experience with hydriodic acid and other List I chemicals, DEA believes
that List I regulatory controls for iodine will help curtail its
widespread use in the clandestine manufacture of methamphetamine and
amphetamine. List I regulatory controls would dictate that handlers of
iodine, including persons who manufacture, import, export, or
distribute iodine, would be required to register with DEA. Retail and
wholesale outlets that sell iodine crystals and covered tinctures/
solutions would also be required to register.
Prior to receiving a DEA chemical registration, handlers are
subject to a pre-registration investigation by DEA in order to
determine the legitimacy of the business per criteria specified under
21 U.S.C. 823(h). Registration also provides the DEA with the identity
of all businesses that handle List I chemicals.
[[Page 46148]]
A business that sells a List I chemical in violation of the law or
regulations can have its registration revoked and be prevented from
handling List I chemicals. The registration requirement is a
disincentive to casual handlers of iodine, who might be used
unwittingly by methamphetamine cooks.
Regulation of Import and Export Transactions
When iodine was controlled as a listed chemical by the
Comprehensive Methamphetamine Control Act of 1996, the bill
specifically exempted it from import and export controls. The MCA,
however, also explicitly provided that Congress was not limiting the
authorization of the Attorney General to impose the import and export
provisions of the CSA on iodine. See Public Law 104-237, Sec. 204.
Because of the international flow of iodine in the production and
distribution of methamphetamine, DEA has determined that the addition
of import and export controls on iodine is necessary. Therefore, 21 CFR
1310.08 is proposed to be amended to remove imports and exports of
iodine as excluded transactions. Thus, iodine would become subject to
the import and export notification provisions of the CSA.
Elimination of the Iodine Threshold
Transactions involving listed chemicals--including cumulative
transactions in a single calendar month--below a quantity threshold,
specified pursuant to 21 U.S.C. 802(39)(A), are excluded from the
definition of ``regulated transaction.'' Currently, the threshold for
iodine is 400 grams (0.4 kilograms). Thresholds denote a quantity below
which regulation is not necessary for law enforcement purposes.
However, DEA has determined that the regulation of all transactions of
regulated iodine products is necessary in order to prevent diversion.
Thus, DEA is proposing to remove the threshold for iodine. Therefore,
all transactions of regulated iodine products would be considered
regulated transactions regardless of size.
Household uses for the regulated iodine products proposed to be
controlled as List I chemicals by this NPRM are very limited. These
regulated iodine materials (i.e. iodine crystals and tinctures and
solution of greater than 2.2 percent iodine) are used in specialized
applications, such as antiseptics in the care of large animals,
sanitation for dairies, chemical lab tests, and as a source of iodine
in saltwater aquariums. For some of the uses, two ounces can last
several months.
DEA considered adjusting the threshold to exclude transactions of
two ounces or below from regulatory control. However, the most common
smaller size iodine container that DEA identified in clandestine
laboratories is two ounces, which contains 56 grams of iodine. DEA
estimates that 56 grams of iodine can produce over 50 grams of pure
methamphetamine. Therefore, DEA determined that a 2-ounce quantity is
useful to traffickers and should be regulated.
III. Proposed Regulation To Identify Exempt Iodine Chemical Mixtures
Definition of Chemical Mixtures
The CSA (21 U.S.C. 802(40)) defines the term ``chemical mixture''
as ``a combination of two or more chemical substances, at least one of
which is not a List I chemical or a List II chemical, except that such
term does not include any combination of a List I chemical or a List II
chemical with another chemical that is present solely as an impurity.''
Therefore, a chemical mixture contains any one or more listed chemical
along with any number of non-listed chemicals.
DEA does not consider a chemical mixture to mean the combination of
a listed chemical with an inert carrier. An inert carrier can be any
chemical that does not interfere with the listed chemical's function
but is present to aid in the delivery of the listed chemical so it can
be used in some chemical process. Examples include, but are not limited
to, solutions of listed chemicals such as methylamine in water or
hydrogen chloride dissolved in water or alcohol.
Iodine tinctures and solutions are considered chemical mixtures
because they require the addition of iodine and an iodide salt into a
water or water/alcohol solution. It is not simply iodine dissolved in
an inert carrier. These iodine tinctures and solutions are therefore
chemical mixtures in the regulatory sense.
Regulation of Chemical Mixtures
The Chemical Diversion and Trafficking Act of 1988 (Pub. L. 100-
690)(CDTA) created the definition of ``chemical mixture'' (21 U.S.C.
802(40)), and exempted chemical mixtures from regulatory control. The
CDTA established 21 U.S.C. 802(39)(A)(v) to exclude ``any transaction
in a chemical mixture'' from the definition of a ``regulated
transaction.'' This exemption of all chemical mixtures provided
traffickers with an unregulated source for obtaining listed chemicals
for use in the illicit manufacture of controlled substances.
The Domestic Chemical Diversion Control Act of 1993 (DCDCA),
enacted in April 1994 subjected chemical mixtures containing listed
chemicals to CSA regulatory requirements, unless specifically exempted
by regulation. These requirements include recordkeeping, reporting, and
security for all regulated chemical mixtures with the requirement added
by the DCDCA of registration for handlers of regulated List I chemical
mixtures.
The DCDCA also amended 21 U.S.C. 802(39)(A)(v) to provide the
Attorney General with the authority to establish regulations exempting
chemical mixtures from the definition of a ``regulated transaction.''
However, exclusion from this definition can only be made ``based on a
finding that the mixture is formulated in such a way that it cannot be
easily used in the illicit production of a controlled substance and
that the listed chemical or chemicals contained in the mixture cannot
be readily recovered.'' DEA has established the following three-tiered
approach to identify which chemical mixtures qualify for automatic
exemption: (1) The mixture contains a listed chemical at or below an
established concentration limit; or (2) the mixture falls within a
specifically defined category; or (3) the manufacturer of the mixture
applies for and is granted a specific exemption for the product (68 FR
23195, May 1, 2003.)
This NPRM proposes regulations that identify which iodine chemical
mixtures qualify for automatic exemption because they meet the
requirements of 21 U.S.C. 802(39)(A)(v). Once finalized, those iodine
chemical mixtures that do not qualify for automatic exemption would be
regulated chemicals, unless the manufacturer has been granted specific
exemption for their product(s) by DEA via an application process (21
CFR 1310.13).
Federal Register Publications Addressing Iodine Chemical Mixtures
Regulations regarding the exemption of chemical mixtures, including
those containing iodine, were initially proposed by DEA on October 13,
1994, as part of its proposed regulations to implement the DCDCA (59 FR
51888). In response to industry concerns, the proposed regulations
regarding the exemption process for chemical mixtures were withdrawn on
December 9, 1994 (59 FR 63738). DEA proposed new regulations regarding
the exemption of chemical mixtures by publishing a new NPRM entitled
``Exemption of Chemical Mixtures'' in
[[Page 46149]]
the Federal Register (63 FR 49506, September 16, 1998).
Iodine chemical mixtures, including iodine tinctures and solutions,
were not a serious concern to law enforcement at the time DEA was
drafting the 1998 proposed regulations regarding chemical mixtures.
Therefore, a 20 percent concentration limit was proposed for iodine.
In addition to information obtained from DEA investigations, open
sources, and communication with the regulated community, DEA also
relies on comments to the NPRM to help establish final regulations.
Comments to the NPRM ``Exemption of Chemical Mixtures'' informed DEA
that seven percent iodine chemical mixtures are being used in the
illicit manufacture of methamphetamine. Based on this information and
the mounting evidence gathered by DEA that iodine is being extracted
from these chemical mixtures for illicit purposes, DEA determined that
the proposed concentration limit of 20 percent for iodine is too high
compared to the concentration of iodine contained in mixtures being
diverted by traffickers. Therefore, the final chemical mixture
rulemaking published on December 15, 2004 [69 FR 74957], withdrew the
iodine portion. Instead, DEA decided to address the iodine chemical
mixture issue separately and is doing so under this NPRM. Since seven
percent iodine tincture and solutions are the predominant iodine-
containing chemical mixtures diverted by traffickers, DEA has
determined that these chemical mixtures should be subject to CSA
chemical regulatory controls. Two percent iodine tincture and solutions
are also diverted, but DEA has not documented the frequent diversion of
these materials at clandestine laboratories. Therefore, DEA does not
intend to regulate the two percent iodine tincture or solution at this
time.
DEA is also aware of other materials that contain iodine. Examples
include iodophor complexes such as poloxamer-iodine and povidone-
iodine. These materials are not of concern to DEA as a source of iodine
for clandestine laboratories. This NPRM proposes that these materials
be specifically exempted from CSA chemical regulatory controls pursuant
to 21 CFR 1310.12 by adding a new paragraph (d)(4) which will exempt
``Iodine products classified as iodophors which exist as an iodine
complex to include poloxamer-iodine complex, polyvinyl pyrrolidone-
iodine complex (i.e. povidone-iodine), undecoylium chloride iodine,
nonylphenoxypoly (ethyleneoxy) ethanol-iodine complex, iodine complex
with phosphate ester of alkylaryloxy polyethylene glycol, and iodine
complex with ammonium ether sulfate/polyoxyethylene sorbitan
monolaurate.''
Exemption by Application Process
DEA recognizes that the 2.2 percent iodine concentration limit and
category exemption criteria cannot identify all mixtures that should
receive exemption status. DEA has implemented an application process to
exempt additional mixtures (21 CFR 1310.13). This application process
was finalized in the Federal Register Notice (68 FR 23195) published
May 1, 2003. Under the application process, manufacturers may submit an
application for exemption for those mixtures that do not qualify for
automatic exemption. Exemption status can be granted if DEA determines
that the mixture is formulated in such a way that it cannot be easily
used in the illicit production of a controlled substance and the listed
chemical cannot be readily recovered (i.e., it meets the conditions in
21 U.S.C. 802(39)(A)(v)). An application may be for a single or a
multiple number of formulations. All chemical mixtures which are
granted exemption via the application process will be listed in 21 CFR
1310.13(i).
Specific Requirements That Will Apply to Regulated Chemical Mixtures
Containing Iodine
DEA is proposing that a chemical mixture that is regulated because
it contains greater than 2.2 percent iodine will be treated as a List I
chemical. Therefore, the same requirements for registration, records
and reports, imports/exports (except that pertaining to 21 U.S.C. 957),
and administrative inspection, as outlined below, apply to handlers of
regulated chemical mixtures.
Requirements That Apply to Regulated List I Chemicals and Their
Regulated Chemical Mixtures
In light of the proposal to place iodine in 21 CFR 1310.02(a) (List
I) and to control chemical mixtures containing greater than 2.2 percent
iodine, the following requirements for List I chemicals are outlined.
Chemical mixtures that are not exempt or excluded under any provision
of these regulations, either by concentration limit, general category
or as a result of DEA action on a specific application for exemption,
shall be considered regulated chemical mixtures. Persons interested in
handling List I chemicals, including regulated chemical mixtures
containing List I chemicals, must comply with the following:
1. Registration. Any person who manufactures or distributes a List
I chemical, or proposes to engage in the manufacture or distribution of
a List I chemical, must obtain a registration pursuant to the CSA (21
U.S.C. 822). Regulations describing registration for List I chemical
handlers are set forth in 21 CFR part 1309.
Separate registration is required for distribution, importing, and
exporting. Different locations operated by a single entity require
separate registration if any location is involved with the
distribution, import, or export of a List I chemical. Any person
distributing, importing, or exporting a regulated List I chemical
mixture is subject to the registration requirement under the CSA. DEA
recognizes, however, that it is not possible for persons who
distribute, import, or export iodine, upon its placement in List I, to
immediately complete and submit an application for registration and for
DEA to issue registrations immediately for those activities. Therefore,
to allow continued legitimate commerce in iodine, DEA is proposing to
establish in 21 CFR 1310.09 a temporary exemption from the registration
requirement for persons desiring to distribute, import, or export
iodine, provided that DEA receives a properly completed application for
registration on or before 60 days from the date of publication of a
final rule. The temporary exemption for such persons will remain in
effect until DEA takes final action on their application for
registration.
The temporary exemption applies solely to the registration
requirement; all other chemical control requirements, including
recordkeeping and reporting, will remain in effect. Additionally, the
temporary exemption does not suspend applicable federal criminal laws
relating to iodine, nor does it supersede state or local laws or
regulations. All handlers of iodine must comply with their state and
local requirements in addition to the CSA and other federal regulatory
controls.
2. Records and Reports. The CSA (21 U.S.C. 830) requires that
certain records be kept and reports be made that involve listed
chemicals. Regulations describing recordkeeping and reporting
requirements are set forth in 21 CFR Part 1310. A record must be made
and maintained for two years after the date of a transaction involving
a listed chemical, provided the transaction is a regulated transaction.
Each regulated bulk manufacturer of a regulated mixture shall
submit manufacturing, inventory and use data on an annual basis (21 CFR
1310.05(d)). Bulk manufacturers producing the
[[Page 46150]]
mixture solely for internal consumption, e.g., formulating a non-
regulated mixture, are not required to submit this information.
Existing standard industry reports containing the required information
are acceptable, provided the information is readily retrievable from
the report.
Title 21 CFR 1310.05 requires that each regulated person shall
report to DEA any regulated transaction involving an extraordinary
quantity of a listed chemical, an uncommon method of payment or
delivery, or any other circumstance that the regulated person believes
may indicate that the listed chemical will be used in violation of the
CSA.
3. Import/Export. All imports/exports of a listed chemical shall
comply with the CSA (21 U.S.C. 957 and 971). Regulations for
importation and exportation of List I chemicals are described in 21 CFR
1313. Separate registration is necessary for each activity (21 CFR
1309.22).
4. Security: All applicants and registrants shall provide effective
controls against theft and diversion of chemicals as described in 21
CFR 1309.71.
5. Administrative Inspection. Places, including factories,
warehouses, or other establishments and conveyances, where regulated
persons may lawfully hold, manufacture, or distribute, dispense,
administer, or otherwise dispose of a regulated chemical/chemical
mixture or where records relating to those activities are maintained,
are controlled premises as defined in 21 CFR 1316.02(c). The CSA (21
U.S.C. 880) allows for administrative inspections of these controlled
premises as provided in 21 CFR 1316 Subpart A.
The goal of this rulemaking is to deny traffickers unregulated
access to iodine while minimizing the burden on legitimate industry.
Persons who obtain a regulated chemical but do not distribute the
chemical are end users. End users are not subject to CSA chemical
regulatory control provisions such as registration or recordkeeping
requirements. Some examples of end users are those who chemically react
iodine and change it into a non-listed chemical, formulate iodine into
an exempt chemical mixture or consume it in some industrial process, or
use it for water treatment or sanitation.
Regulatory Certifications
Regulatory Flexibility and Small Business Concerns
The Regulatory Flexibility Act (5 U.S.C. 600-612) requires agencies
to determine whether a proposed rule will have a significant economic
impact on a substantial number of small entities (SEISNOSE). If an
agency finds that there is a SEISNOSE, the agency must consider whether
alternative approaches could mitigate the impact on small entities. The
size criteria for small entities are defined by the Small Business
Administration (SBA) in 13 CFR 121.201. As discussed below, DEA has
researched the production and marketing of iodine to determine whether
the proposed rule could have a SEISNOSE.
The majority of firms potentially subject to the proposed rule are
considered small entities under the Small Business Administration
definitions for the affected sectors.\1\ The only firms for which the
rule would have a significant economic impact are those with revenues
or sales of less than about $100,000 a year; the initial registration
time and fee would represent one percent of their revenues. Economic
Census data indicate that even the smallest firms in the affected
sectors have sales well above the $100,000 a year level.\2\
Consequently, DEA concludes the proposed rule is unlikely to have a
significant economic impact on a substantial number of small entities.
DEA recognizes, however, that there may be a very small number of firms
marketing specialty products that may be adversely affected because
they offer no other products. DEA is seeking comment on whether there
could be a significant economic impact on a substantial number of small
entities.
---------------------------------------------------------------------------
\1\ See Table 3 for the SBA size standards for affected
entities.
\2\ See Table 3 for the average revenue for the smallest firms.
---------------------------------------------------------------------------
Initial Regulatory Flexibility Analysis
Potential Universe of All Affected Entities
In broad terms, three companies produce iodine in bulk and
distribute it to other companies that either use it in chemical
manufacturing, purify it and repackage it, or simply repackage it for
further sale. There may be a third step at the manufacturing level
where iodine crystals or solutions are purchased in bulk from companies
that purified it and are then repackaged for retail sales. Although
some iodine products are likely to follow the normal distribution chain
of manufacturer to wholesaler to retailer, others do not. Most chemical
manufacturers are likely to purchase iodine directly from other
manufacturers. Some of the ``manufacturers'' of iodine products appear
to sell both to retail outlets and directly to consumers. Many of the
manufacturers offer catalogue and Internet sales.
In addition to the three manufacturers that produce iodine as a
bulk chemical, DEA identified 43 firms that have developed material
safety data sheets (MSDSs) for iodine products that would be covered by
the proposed rule; five of these are already registered as chemical
manufacturers. It is not possible to determine whether the DEA
registrants produce iodine at registered locations or whether any of
the 43 firms produce iodine products at multiple locations.\3\ Eight
other chemical manufacturers list iodine as a product; one of these is
registered as a chemical importer and exporter. There may be other
firms producing iodine for industrial uses whose MSDSs are not publicly
available.\4\ DEA is seeking comments on whether such information
exists that could help in further identifying the entities the rule
will potentially impact.
---------------------------------------------------------------------------
\3\ The CSA requires that each location where a controlled
substance or List I chemical is handled have a separate
registration.
\4\ OSHA requires the manufacturer of a chemical to develop an
MSDS. Other firms that package or distribute the chemical must
provide the MSDS, but generally use the MSDS acquired from the
original manufacturer. MSDSs must be made available to employees and
to firms that purchase the chemical, but publishing them for the
general public is not required.
---------------------------------------------------------------------------
DEA identified 15 other manufacturers of iodine products. It is
likely that these firms purchase iodine crystals and repackage them or
purchase crystals or concentrated solutions and dilute them prior to
repackaging. Because some of these firms may operate at multiple
locations and because it is likely that not all manufacturers have been
identified, the analysis estimates that there are between 75 and 90
manufacturers of iodine products.
Iodine products may be handled by a variety of wholesalers. The
livestock and science kit products could be handled by drug, chemical,
or agricultural wholesalers. Current Duns data indicate that 267
wholesalers distribute animal medicines; these are the wholesalers most
likely to be distributing iodine products for horses. Some of these
distributors may already be registered to handle controlled substances.
The 2002 Economic Census for the wholesale industry indicated that
about 1,115 agricultural wholesalers/retailers may carry tack shop
materials. It is possible that other chemical wholesalers may be
providing iodine to manufacturers of iodine products, but DEA considers
it more likely that these manufacturers purchase iodine in bulk
directly from chemical manufacturers. DEA has not identified
[[Page 46151]]
any data that indicate the number of wholesalers who distribute
aquarium chemicals, but as there appears to be only one such covered
product marketed specifically for aquariums (Kent Marine Lugol
solution), it may not be handled by a large number of wholesalers.
Similarly, Census classifications do not cover camping goods or science
kits at the wholesale level. The Web site for Polar Pure lists only two
wholesale distributors. Overall, DEA estimates that the number of
wholesalers may range from 300 to 1,400. DEA seeks comments on such
approximation.
At the retail level, tinctures are sold by tack shops; 2005 Duns
data list about 4,080 such retailers. Agricultural retailers may also
sell these products for livestock, but these are included in the
wholesale estimate because the Census combines agricultural wholesalers
and retailers in a single classification. Veterinarians may also sell
the products, but would not be subject to registration because they are
already registered to handle controlled substances.
The 2002 Census indicated that there were 5,039 pet stores that
sold aquarium supplies. A check of two large chains, which have more
than 1,400 stores between them, indicates that although both stock some
iodine supplements, neither stock Lugol's solution. DEA estimates that
between one percent and five percent of pet stores would carry iodine
either as crystals or strong tinctures. Although nursery/garden
retailers and building supplies/garden retailers sell pet supplies, it
is unlikely that any of them carry covered iodine products.
The Census listed about 1,524 sporting good specialty stores that
carry camping supplies. DEA has included 5 percent to 10 percent of
them. Mail order and Internet outlets sell all of the iodine products.
DEA has no basis for estimating how many of these outlets sell iodine
products without being associated with either wholesale or retail
outlets that would be included in other counts. DEA has included 50 to
100 of these, but recognizes that these numbers could be either too low
or too high. Table 1 presents the estimated low to high range of
potentially regulated entities.
Table 1.--Potentially Regulated Universe
------------------------------------------------------------------------
Low High
------------------------------------------------------------------------
New manufacturers............................. 75 90
Wholesalers................................... 300 1,400
Tack shops.................................... 2,040 4,080
Pet supplies.................................. 50 250
Camping supplies.............................. 75 150
Other......................................... 50 100
-------------------------
Total..................................... 2,590 6,070
------------------------------------------------------------------------
The estimates in Table 1 represent the number of outlets that may
currently handle products that would be subject to the proposed rule.
In estimating the number of new registrants, however, DEA has to
consider whether these outlets will elect to register and continue
selling the products. For almost all of the entities listed in Table 1,
iodine products are a minor item. The manufacturers, wholesalers, and
mail order/Internet suppliers routinely collect the information DEA
would require under the proposed rule; this information is necessary
for them to ship the product. Other than the registration fees, the
rule would not impose a burden on them although it is possible that
some of these outlets may elect to drop iodine products rather than be
subject to DEA rules.
Store retailers face a different situation. Not only are their
revenues usually lower than those of manufacturers and wholesalers, but
they are also unlikely to routinely collect all of the information DEA
requires for these transactions. Because the cost of the iodine
products is low ($5 to $20), many of the transactions may be in cash.
To teach their clerks what is required, explain to customers why the
information is needed, transcribe the data, and maintain the record may
be too great a burden for a specialty product that is unlikely to be in
high demand and for which reasonable substitutes exist. DEA expects,
therefore, that most store retailers will stop carrying these products
and direct their customers to substitutes or to mail order or Internet
sources. This shift would, in turn, likely reduce the number of
wholesale distributors handling the products. Table 2 provides a more
likely estimate of the potential number of new registrants, but even
these estimates are likely to be high because most wholesale and retail
outlets may elect to avoid DEA regulation.
Table 2.--Potential Number of Registrants
------------------------------------------------------------------------
Low High
------------------------------------------------------------------------
New manufacturers............................. 75 90
Chemical wholesalers.......................... 150 700
Other......................................... 50 100
-------------------------
Total..................................... 275 890
------------------------------------------------------------------------
Small Entities Likely To Be Affected by This Rule
The SBA standards for the potentially affected sectors are shown in
Table 3 as are the average sales or value of shipments (for
manufacturers) for the smallest firms reported in the 2002 Economic
Census:
Table 3.--Small Business Standards for Sectors
----------------------------------------------------------------------------------------------------------------
Size standard Average sales/smallest firms**
----------------------------------------------------------------------------------------------------------------
Inorganic chemical manufacturers....... 1,000 FTE*................... $4.25 million.
Pharmaceutical manufacturers........... 750 FTE...................... $824,000.
Miscellaneous manufacturers............ 500 FTE......................
Chemicals wholesalers.................. 100 FTE...................... $1 million.
Sporting goods and pet stores.......... $6.5 million................. $345,000 (sporting)
$274,000 (pet).
Electronic/mail order shopping......... $23 million.................. $528,000 (electronic)
$497,000 (mail).
----------------------------------------------------------------------------------------------------------------
* FTE is an abbreviation for Full Time Equivalent (Employees).
** 1 to 4 FTE except for inorganic chemical, where data available only for 5-9 FTE.
[[Page 46152]]
Because of the size standards, it is highly likely that a
substantial number of the firms that will be regulated will be
considered small businesses. DEA has no information on the number of
potentially regulated entities that would be classified as small and is
seeking comment on this issue.
The three main manufacturers of iodine are large firms; two of the
three are also foreign-owned and the third is a joint venture with
foreign firms.
Specific Requirements Imposed That Would Impact Small Entities
Firms that handle iodine will be required to register with DEA. At
present, the registration fee is $595; the reregistration fee is $477.
Each of the firms will also be required to become familiar with DEA's
regulations, to maintain records of each sale, and to report to DEA on
unusual sales and thefts/losses. Bulk manufacturers must file annual
reports, but these reports already apply to iodine as a List II
chemical, so impose no new burden. DEA specifies that normal business
records may be used to meet the requirements of records of sales.
Importers and exporters would be required to file an advance
notification for each importation or exportation.
DEA estimates that it takes a firm a half hour to complete and
submit a registration, which can be done online. In addition, DEA
estimates that it will take four hours to become familiar with the
regulations that apply. DEA assumes that rule familiarization and
registration will be done by managerial staff. The cost for initial
compliance for firms in manufacturing, wholesale, and retail sectors is
shown in Table 4. Wage rates are based on November 2004 BLS industry
data and loaded with fringe and overhead. Fringe rates are based on BLS
``Employer Costs for Employee Compensation--December 2005'' for
management for goods producing and service industries, as applicable.
Overhead is loaded at 56 percent of compensation, based on the most
recent Grant Thornton survey.
Table 4.--Initial Compliance Cost per Firm
----------------------------------------------------------------------------------------------------------------
Total cost
Sector Wage rate Total labor with fee
----------------------------------------------------------------------------------------------------------------
Manufacturing................................................... $127 $573 $1,168
Wholesale....................................................... 98 442 1,037
Retail.......................................................... 60 269 864
Mail order/Electronic........................................... 91 408 1,003
----------------------------------------------------------------------------------------------------------------
A comparison of the initial compliance costs in Table 4 with the
annual revenues or sales of the smallest firms shown in Table 3
indicates that the costs do not approach one percent of sales or
revenues of the smallest firms in each sector and, therefore, do not
impose a significant economic burden on firms. The recurring costs for
renewal are lower (a half hour of labor plus the reregistration fee).
DEA estimates that completing the advance notification (Form 486) for
imports and exports requires less than 15 minutes. DEA is seeking
comments on these estimates.
Reporting and Recordkeeping Requirements
Firms subject to the rule will be required to maintain records of
sales. The records required include the date of the sale; the name,
quantity, and form of packaging of the chemical; the method of
transfer; and the type of identification used by the purchaser and any
unique number on that identification. Routine sales records for credit
card or mail order sales will include the required information.
Manufacturers and wholesalers, which normally sell products through
purchase orders, will not have to create any additional records. As
noted above, retailers that have cash sales would have to create new
records if they continue to sell the products. Because these products
represent such a small percentage of any store's sales and there are
products that can be substituted for them, DEA considers that it is
unlikely that retailers will register and continue to sell iodine
products.
Importers and exporters would have to file a Form 486 15 days in
advance of any importation or exportation. If the importer meets the
requirements to be a regular importer, the person must file the form on
or before the date of importation, but does not require DEA approval.
Similarly, exporters that have an established business relationship
with a foreign customer need to file the form by the date of
exportation.
Alternatives
Pursuant to the requirements of the RFA, DEA has evaluated
alternatives to this proposed rule and determined that no reasonable
alternatives exist. This NPRM proposes changes to the regulatory
control of iodine in an effort to prevent the diversion of iodine for
the illicit production of methamphetamine and amphetamine. Providing
small businesses with alternatives and/or exemptions from the proposed
rule would eliminate the regulatory objective behind the rule. DEA has
proposed ways to lessen the regulations' economic impact on all
entities covered by the rule. This NPRM proposes regulatory controls
that will apply to iodine crystals and iodine chemical mixtures that
contain greater than 2.2 percent iodine thereby eliminating the
majority of products that use iodine from the requirements of this
regulation.\5\ Also, this proposed rule allows manufacturers to seek
exemption for additional mixtures of iodine that do not qualify for
automatic exemption under 21 CFR 1310.13. DEA seeks comments on
reasonable alternatives to this rule that will serve to lessen its
impact on small businesses while maintaining the regulatory objective
of regulating iodine crystals and strong tinctures and chemical
mixtures containing over 2.2 percent iodine.
---------------------------------------------------------------------------
\5\ See the section in this regulation on the legitimate uses of
iodine.
---------------------------------------------------------------------------
Additional Impact Issues Raised
DEA expects that most store retailers will elect not to sell iodine
crystals or strong tinctures rather than registering and maintaining
sales records. Most iodine products with household applications would
not be subject to the rule. DEA considered whether the loss of product
sales would have a significant economic impact on retailers. DEA will
seek comment on this issue, but in general does not expect an impact.
These products make up a very small part of the sales of any pet or
sporting goods store. Eliminating the product line is unlikely to have
a noticeable effect on sales even if customers continue to seek the
products from on line or mail order sources. In most cases, customers
will be able to purchase substitutes that are no more expensive, and in
some cases, are less expensive. DEA, therefore, expects that
[[Page 46153]]
the impact on sales at the retail level will be minimal.
The impact on manufacturers, with one possible exception, is also
likely to be minimal. DEA's research indicates that the manufacturers
who produce iodine tinctures and crystals for use with livestock and
fish also produce and market the substitutes. If sales of these iodine
products decline, it is likely that the sales of substitutes will
increase. Many of these companies also sell directly to customers
through catalogues and on line. Because the sales records required
under the rules are the same records the companies create for mail
order or on line sales, there would be no burden beyond registration
for these firms to meet these requirements. The one exception is a
small company that apparently markets a single product using iodine
crystals. To the extent that in-store sales of its product decline and
are not replaced with on line sales, the rule could have a significant
impact on the firm.
Executive Order 12866
The Deputy Administrator hereby certifies that this rulemaking has
been drafted in accordance with Executive Order 12866, Section 1(b). It
has been determined that this rule is a ``significant regulatory
action''. Therefore, this action has been reviewed by the Office of
Management and Budget.
This proposed rule would impose new regulatory requirements on
businesses choosing to handle iodine tinctures, iodine crystals and
chemical mixtures containing iodine including registration with DEA,
recordkeeping, the submission of certain reports regarding import and
export transactions to DEA, and security requirements. DEA believes
that the requirement of recordkeeping for regulated transactions
involving iodine tinctures, crystals and chemical mixtures containing
iodine are already accomplished through the maintenance of business
records as a usual and customary business practice. Likewise, security
occurs as a normal part of good business practice. DEA believes these
new regulatory requirements are necessary to prevent the diversion of
iodine to the illicit production of methamphetamine and amphetamine.
Based on the costs and number of regulated entities discussed in
the previous section, DEA estimates that the total cost of initial
compliance with the proposed rule would range from $293,000 to
$931,000; annual costs thereafter could range from $146,000 to
$469,000.
Costs of Methamphetamine Abuse/Benefits of Rulemaking
Methamphetamine is the most prevalent controlled substance
illicitly synthesized in the United States. The clandestine
manufacture, distribution and abuse of methamphetamine are serious
public health problems. Despite considerable efforts by Federal, state,
and local law enforcement, the illicit trafficking and abuse of
methamphetamine continue.
According to the 2003 National Survey on Drug Use and Health,
approximately 12.3 million Americans ages 12 and older reported trying
methamphetamine at least once during their lifetimes, representing 5.2%
of the population ages 12 and older. Approximately 1.3 million (0.6%)
reported past year methamphetamine use and 607,000 (0.3%) reported past
month methamphetamine use. In 2004, the Monitoring the Future Study
which assesses the extent of drug use among adolescents (8th, 10th and
12th graders) indicated that 6.2 percent of high school seniors
reported some prior lifetime use of methamphetamine, statistically
unchanged from 2003. Some prior lifetime use of methamphetamine was
reported by 5.3 percent of 10th grade students.
The consequences of methamphetamine use appear to be trending
upward. The Drug Abuse Warning Network (DAWN) data indicate that the
estimated number of emergency department (ED) mentions for
methamphetamine increased steadily, from 10,447 in 1999, to 13,505 in
2000, to 14,923 in 2001, and to 17,696 in 2002, although the percentage
increase from 2001 to 2002 is not statistically significant. Similarly,
the estimated rate of ED mentions per 100,000 population has increased
from 4 in 1999, to 5 in 2000, to 6 in 2001, to 7 in 2002. Statistically
significant increases in methamphetamine ED mentions were reported by
San Francisco (19.4%), Seattle (35.3%), and Atlanta (39.0%) between
2001 and 2002. (Note: A visit to the emergency department is referred
to as an episode, and every time a drug is involved in an episode it is
counted as a mention.) According to the DAWN 2002 mortality data, areas
with the highest number of methamphetamine drug-related deaths were
those in the Midwest and Western areas, including Phoenix (132), San
Diego (81), Las Vegas (72), Dallas (46), and San Francisco (38).
The El Paso Intelligence Center (EPIC) reports that there were
10,349 methamphetamine laboratories seized in the U.S. in FY 2004 (as
reported through April 12, 2006). Another rising cost of the
methamphetamine problem is the cost of cleaning up the toxic side
effects of methamphetamine production. Clandestine laboratory sites
must be remediated and chemicals seized at clandestine laboratories
must be removed, and that removal is very expensive. During FY 2004,
DEA administered 10,061 state and local clandestine laboratory cleanups
at a cost of $18.6 million.
The total social and monetary costs from trafficking and abuse of
methamphetamine are abundant. Costs include those incurred to treat
medical consequences of abuse, loss of life and injury to users and by
users to bystanders, abandonment of the children of methamphetamine
abusers (and corresponding cost of social services), theft and property
damage resulting from abuse, loss of employment and productivity,
increased costs to law enforcement, cost of prosecution and
incarceration for crimes associated with drug use, and increased costs
due to cleanups of lab sites. Benefits obtained from implementation of
iodine controls, to counter illicit methamphetamine production, greatly
exceed costs necessary to implement such controls. However, DEA is
seeking public comment on any effect this rule may have on markets.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Reform.
Executive Order 13132
This rulemaking does not preempt or modify any provision of state
law; nor does it impose enforcement responsibilities on any state; nor
does it diminish the power of any state to enforce its own laws.
Accordingly, this rulemaking does not have federalism implications
warranting the application of Executive Order 13132.
Paperwork Reduction Act
This rule proposes changes to the regulation of iodine and proposes
regulations to identify iodine chemical mixtures that are exempt from
CSA regulatory controls pertaining to chemicals. Under this proposal,
persons who handle chemical mixtures with concentration levels of
iodine 2.2 percent and less will not be subject to CSA regulatory
controls, including the requirement to register with DEA.
This Notice of Proposed Rulemaking would require persons handling
iodine crystals, strong iodine tinctures and chemical mixtures
containing iodine to
[[Page 46154]]
register with DEA and to report import and export transactions
involving regulated transactions in these chemicals to DEA.
For purposes of this proposed rulemaking, DEA has estimated the
population of persons potentially required to register with DEA to
handle iodine and its chemical mixtures to be between 275 and 890.
However, some of these persons may already be registered with DEA and
others may decide to no longer handle such products rather than
registering. Therefore, DEA is specifically seeking input from industry
regarding the number of persons who might be affected by this
rulemaking. DEA will not be amending its information collection
regarding chemical registration [OMB information collection 1117-0031
``Application for Registration under Domestic Chemical Diversion
Control Act of 1993 and Renewal Application for Registration under
Domestic Chemical Diversion Control Act of 1993''] pending receipt of
comments regarding the impact of this regulation. DEA will amend its
information collection, as warranted, based on the public comment
received.
Further, this NPRM would require persons importing and exporting
products containing iodine crystals, tinctures and chemical mixtures
controlled by this rule to report such imports and exports to DEA. DEA
cannot accurately estimate how many such transactions occur annually
and, thus, the impact of this reporting requirement to the regulated
industry. DEA is seeking comment from the regulated industry regarding
the impact of this proposed regulation and will amend its information
collection regarding the reporting of import and export transactions
[OMB information collection 1117-0023 ``Import/Export Declaration:
Precursor and Essential Chemicals''], as warranted, based on the public
comment received.
DEA is also soliciting comments on the impact of recordkeeping
requirements upon handlers of regulated iodine products and any
potential impact upon public health given any reduction in availability
of regulated products, especially where it can be quantified.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by state, local, and
tribal governments, in the aggregate, or by the private sector, of
$114,000,000 or more in any one year, and will not significantly or
uniquely affect small governments. Therefore, no actions were deemed
necessary under the provisions of the Unfunded Mandates Reform Act of
1995.
Small Business Regulatory Enforcement Fairness Act of 1996
This rule is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996. This rule
will not result in an annual effect on the economy of $100,000,000 or
more; a major increase in cost or prices; or significant adverse
effects on competition, employment, investment, productivity,
innovation, or on the ability of United States-based companies to
compete with foreign-based companies in domestic and export markets.
List of Subjects in 21 CFR Part 1310
Drug traffic control, Exports, Imports, List I and List II
chemicals, Reporting and recordkeeping requirements.
For the reasons set out above, 21 CFR part 1310 is proposed to be
amended as follows:
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES [AMENDED]
1. The authority citation for part 1310 continues to read as
follows:
Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.
2. Section 1310.02 is amended by adding a new paragraph (a)(28) and
removing paragraph (b)(11) to read as follows:
Sec. 1310.02 Substances covered.
* * * * *
(a) * * *
(28) Iodine 6699
* * * * *
3. Section 1310.04 is amended by removing paragraph (f)(2)(ii)(H);
redesignating (f)(2)(ii)(I) as (f)(2)(ii)(H); and adding a new
paragraph (g)(1)(vi) to read as follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(g) * * *
(1) * * *
(vi) iodine
* * * * *
Sec. 1310.08 [Amended]
4. Section 1310.08 is amended by removing paragraph (f) and
redesignating paragraphs (g) through (l) as paragraphs (f) through (k).
5. Section 1310.09 is amended by adding new paragraph (h) to read
as follows:
Sec. 1310.09 Temporary exemption from registration.
* * * * *
(h) Each person required by section 302 of the Act (21 U.S.C. 822)
to obtain a registration to distribute, import, or export regulated
iodine, including regulated iodine chemical mixtures pursuant to
Sec. Sec. 1310.12 and 1310.13, is temporarily exempted from the
registration requirement, provided that DEA receives a proper
application for registration or application for exemption for a
chemical mixture containing iodine on or before [60 days from date of
publication of a final rule]. The exemption will remain in effect for
each person who has made such application until the Administration has
approved or denied that application. This exemption applies only to
registration; all other chemical control requirements set forth in the
Act and parts 1309, 1310, and 1313 of this chapter remain in full force
and effect. Any person who distributes, imports or exports a chemical
mixture containing iodine whose application for exemption is
subsequently denied by DEA must obtain a registration with DEA. A
temporary exemption from the registration requirement will also be
provided for these persons, provided that DEA receives a properly
completed application for registration on or before 30 days following
the date of official DEA notification that the application for
exemption has not been approved. The temporary exemption for such
persons will remain in effect until DEA takes final action on their
registration application.
6. Section 1310.12 is amended by revising the introductory text of
paragraph (c), by adding an entry for ``Iodine'' in alphabetical order
in the table of paragraph (c), and adding new paragraph (d)(4) to read
as follows:
Sec. 1310.12 Exempt chemical mixtures.
* * * * *
(c) Mixtures containing a listed chemical in concentrations equal
to or less than those specified in the ``Table of Concentration
Limits'' are designated as exempt chemical mixtures for the purpose set
forth in this section. The concentration is determined for liquid-
liquid mixtures by using the volume or weight and for mixtures
containing solids or gases by using the unit of weight.
[[Page 46155]]
Table of Concentration Limits
----------------------------------------------------------------------------------------------------------------
DEA chemical Concentration
List I chemicals code number (percent) Special conditions
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Iodine.................................. 6699 2.2
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(d) * * *
* * * * *
(4) Iodine products classified as iodophors which exist as an
iodine complex to include poloxamer-iodine complex, polyvinyl
pyrrolidone-iodine complex (i.e. povidone-iodine), undecoylium chloride
iodine, nonylphenoxypoly (ethyleneoxy) ethanol-iodine complex, iodine
complex with phosphate ester of alkylaryloxy polyethylene glycol, and
iodine complex with ammonium ether sulfate/polyoxyethylene sorbitan
monolaurate.
Dated: July 6, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6-12353 Filed 8-10-06; 8:45 am]
BILLING CODE 4410-09-P