Federal
Register Notices > Rules
- 2006 >
Changes in the Regulation of Iodine Crystals and Chemical
Mixtures Containing Over 2.2 Percent Iodine
FR Doc E6-12353 [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]
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.
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
|
Iodide (gm.)
|
Sodium Iodide (gm.) |
Potassium Iodine (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
Sector
|
Wage rate
|
Total labor
|
Total cost 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
List I chemicals
|
DEA chemical code number |
Concentration (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
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
|