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evil_lurker
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Iodine and tincture going List I
DEA is at it again. Iodine and Tincture over 2.2% going List I soon.
Posted On: Sep 05 2006 At: 11:31:29 PM
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Proposed Rule: Changes in the Regulation of Iodine Crystals and
Chemical Mixtures Containing Over 2.2 Percent Iodine
Federal Register: August 11, 2006 (Volume 71, Number 155)
Page 46144-46155
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 ofiodine 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 iversion 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 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 I131. DEA is also aware of other radiolabeled
material, such as sodium iodide I123, 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 andamphetamine,
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 dministrator 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 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.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.
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1 See Table 3 for the SBA size standards for affected
entities.2 See Table 3 for the average revenue for the smallest firms.
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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.
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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.
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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.
T
he 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
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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
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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.
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5 See the section in this regulation on the legitimate uses of
iodine.
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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 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.
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
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woelen
Super Administrator
Posts: 8012
Registered: 20-8-2005
Location: Netherlands
Member Is Offline
Mood: interested
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The turds are going on, but this one is not that bad. I read that iodide salts of any form are not affected by these regulations. Salts like KI, NaI
still can be purchased freely and hence, it is easy to make free iodine. Making free iodine from KI or NaI really is easy, just dissolve the salt in
some excess dilute mineral acid and add an excess of 3% H2O2. The iodine quickly settles and can easily be rinsed and separated from the liquid. Use
of excess H2O2 does not result in further oxidation to iodate.
Methcooks also will learn to know that iodides can be used instead, and I'm afraid that it will not take a long time, that iodide salts also will be
regulated.
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Polverone
Now celebrating 21 years of madness
Posts: 3186
Registered: 19-5-2002
Location: The Sunny Pacific Northwest
Member Is Offline
Mood: Waiting for spring
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I think methcooks already know that iodides can be easily processed. I suppose I better take advantage of the window of opportunity to order a couple
kg of NaI. With considerable effort, phosphorus can be made from phosphates, but it would be the very rare amateur who has the means and patience to
obtain iodine from seaweed.
[Edited on 9-6-2006 by Polverone]
PGP Key and corresponding e-mail address
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The_Davster
A pnictogen
Posts: 2861
Registered: 18-11-2003
Member Is Offline
Mood: .
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I can't see Canada being too far behind in such legislation, too bad, I really enjoy iodine chemistry(not drugs) especially the hypervalent stuff.
Sigh. Stocking is getting monotonous.
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phase_dancer
Harmless
Posts: 15
Registered: 30-6-2003
Location: Australia
Member Is Offline
Mood: Happy
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Iodine and iodide salts have been listed Cat # 2 in Australia for some time. Non-account holders wishing to purchase must sign an end user
declaration. Check page 8 of the Code of Practice for Supply Diversion into Illicit Drug Manufacture
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garage chemist
chemical wizard
Posts: 1803
Registered: 16-8-2004
Location: Germany
Member Is Offline
Mood: No Mood
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"End User Declaration", I had to sign several of those in the last year.
I germany, the end user declaration is not only for chems with a potential for abuse, but also for chemicals that pose certain health risks (such as
suspected carcinogenic potential).
For example, if you purchase dichloromethane you have to sign such a declaration and list the purposes you're gonna use the substance for.
The last declaration I had to sign was for acetic anhydride (but this was because of abuse potential, and because AA is a watched substance).
You will eventually have to sign such declarations too.
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woelen
Super Administrator
Posts: 8012
Registered: 20-8-2005
Location: Netherlands
Member Is Offline
Mood: interested
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Is there any risk involved in signing such an end-user declaration? Your name is associated to all kinds of chemical purchases of the not so nice kind
and I'm afraid that could result in an unwanted visit of the police or some other officials.
And if you sign such a thing, then suddenly you can purchase much more chemicals? I'm really surprised to read that you can buy acetic anhydride, by
simply signing an end-user declaration. I thought that such chems like AA only could be purchased if you have a company, or are affiliated to some
official lab, university or whatever.
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mrjeffy321
Hazard to Others
Posts: 149
Registered: 11-6-2005
Member Is Offline
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I wonder if this will be effected,
http://www.jeffersequine.com
I cannot link directly to the product due to the CGI, but do a search for "Iodine 7% Tincture", and it will pop right up.
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pantone159
National Hazard
Posts: 589
Registered: 27-6-2006
Location: Austin, TX, USA
Member Is Offline
Mood: desperate for shade
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Aaarghhhh.... 
This means that the single most reliable method for disinfecting water in the backcountry (camping) will go away. The 'iodine' tablets (which are not
elemental iodine) work fine but will eventually go bad, elemental iodine is however sure to work even if many years old.
Stocking up on elemental iodine is not so attractive as the stuff is a pain to store.
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neutrino
International Hazard
Posts: 1583
Registered: 20-8-2004
Location: USA
Member Is Offline
Mood: oscillating
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I store mine in a teflon-lined vial without problem.
Have a look at these:
3.75 mL
7.5 mL
15 mL
30 mL
Go forth and stock up while you still can. 
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Chemist514
Hazard to Self
Posts: 68
Registered: 12-5-2006
Member Is Offline
Mood: No Mood
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End User Dec's...
Woelen : I figured id be a "lab rat" for this (I'm new to the hobby and pretty much just play with a chemistry set with my kids, if you see any of my
back posts thats pretty obvious.) as im still purchasing the chems in my chemistry sets list of contents i came to one they said i couldnt buy...
potassium permanganate
On further inquire it turned out that it would be ok if i signed a form.. not much on it really, other then exactly what im doing with the chem (ie:
reactant's, mechanism, products etc) AND a huge bunch of legal mumbo jumbo threatening me with masive legal assult if i RESELL it. Id say 80% of it
was making sure it never leaves your hands.
That was in Canada and from a medium size chemical supplier, its been about 4-5 months no phone calls or black helicoptors yet. :>
Hope its some info you can use.
I need a less impressive nickname.. as i have no skillz.
gotta make time for that later, all the best people!
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woelen
Super Administrator
Posts: 8012
Registered: 20-8-2005
Location: Netherlands
Member Is Offline
Mood: interested
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| Quote: | Originally posted by neutrino
I store mine in a teflon-lined vial without problem.
Have a look at these:
3.75 mL
7.5 mL
15 mL
30 mL
Go forth and stock up while you still can. |
Wow, these look very interesting. Are they also compatible with bromine, or are the caps eaten, and/or does the bromine slowly leak out of them? Did
you ever try storing some bromine in such a small bottle? I'm inclined to order a lot of these nice little things, only wonder how much the shipping
will be to Europe from this company. Their prices are good.
@Chemist514: It is good that you can still buy chemicals from a chemical supply house. Where I live, not a single chemical supply house is willing to
sell to individuals. You have to be affiliated with a lab, or a company of the correct type. I have found my ways in the mean time and have found
alternative ways. Also in Canada, there is a company, which sells a whole bunch of interesting chems, without any paperwork, even to people in Europe.
So, they certainly should sell to you as a Canadian citizen. Send a U2U if you want to know the source. I do not post it here, k3wls may also be
reading this.
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chloric1
International Hazard
Posts: 1137
Registered: 8-10-2003
Location: GroupVII of the periodic table
Member Is Offline
Mood: Stoichiometrically Balanced
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Ahem, with every passing day global communist tyranny tightens its death grip. COME ON ARMAGEDDEN!
[Edited on 9/10/2006 by chloric1]
Fellow molecular manipulator
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neutrino
International Hazard
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Registered: 20-8-2004
Location: USA
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I store my bromine and iodine in caps with Teflon-lined caps. I haven’t noticed any leakage, although I haven’t really checked that well.
I should note that my vial liners are home-made from 1mm Teflon sheet. I don’t have any experience with Cynmar’s vials, but I expect they should
work equally well.
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The_deadly_dustbin
Harmless
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| Quote: | Originally posted by woelen
Is there any risk involved in signing such an end-user declaration? Your name is associated to all kinds of chemical purchases of the not so nice kind
and I'm afraid that could result in an unwanted visit of the police or some other officials.
And if you sign such a thing, then suddenly you can purchase much more chemicals? I'm really surprised to read that you can buy acetic anhydride, by
simply signing an end-user declaration. I thought that such chems like AA only could be purchased if you have a company, or are affiliated to some
official lab, university or whatever. |
The answer to this is a definite: "That depends on....!"
In oder to cover their asses the few chemical supply companies that still sell to individuals in Germany keep track of your purchases. If you call
them up to tell them: "I'd like to order some Bezaldehyde, Alanine, Iodine, Phosphorous, Methylenechloride and ummmmm let's see..... oh yeah add some
Acetic Anhydride and a Kilo of Potassiumpermanganate" you'l probably only hear the "click" at the other end of the line. It' mostly a matter of having
a good relationship with the guys from the chemical supply house. If they know you for some time you'll get a lot of the "supicious" stuff in small
amounts (let's say 250 g). Also the list of watched substances in Germany isn't as long as the List 1 and 2 in the US. The GÜG just has the direct
precursors (Ephedrine, Saffrole, Piperonal, P2P etc) scheduled as list one. The list 2 chems (Potasiumpermanganate, Acetic Anhydride etc.) are not
really easy to obtain, but there will be no jackbooted thugs kickin' in your door 2 days after you recieved them.
But here the cops don't have a eye on drug-precursors (The Netherlands and Polan/Tchech Republic are close enough to keep the prices for stimulants
pretty low and ther's little need for some chem-hacks to make their own). There was however a surge of search and seizure due to some morons selling
pyro-chems to underaged idiots over the internet and the German government uses war on terrorism as a good opportunity to tighten the screws.
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quicksilver
International Hazard
Posts: 1820
Registered: 7-9-2005
Location: Inches from the keyboard....
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Mood: ~-=SWINGS=-~
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| Quote: | Originally posted by woelen
Is there any risk involved in signing such an end-user declaration? Your name is associated to all kinds of chemical purchases of the not so nice kind
and I'm afraid that could result in an unwanted visit of the police or some other officials.
And if you sign such a thing, then suddenly you can purchase much more chemicals? I'm really surprised to read that you can buy acetic anhydride, by
simply signing an end-user declaration. I thought that such chems like AA only could be purchased if you have a company, or are affiliated to some
official lab, university or whatever. |
I think one should be realistic. Most all of us are already ON a Hell of a lot of lists. Have you ever purchased any chems from a major supplier?
Joined a club or organization for hobbiests or at a university? Posted on boards such as this one? We are already on (possibly) multiple lists! Being
on a list doesn't mean anything beyond being on the list. Remember when CPSC was ending "the letter" to customers of pyrotechnic outlets? They had a
seriously large list from the customers of 4 major outlets (they claimed). They did this to "curb" m80 manufacture (rediculous as it may seem). If you
don't break the law I doubt that anyone would bother you. Big government is your friend. InterPol has a 'net monitor desk with dozens of people monitoring websites around the globe and maintaining databases for individual
countries (but that is mostly about child abuse, etc). but this monster -=IS=- loose gentelmen....
[Edited on 13-9-2006 by quicksilver]
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UniversalSolvent
Harmless
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Fuckers. Iodine is some pretty useful stuff; mixing up NI3 is a good conversation starter.
But all is well as long as I can get some potassium iodide, sodium bisulfate, and manganese dioxide; that way, I can sublimate my own crystals. The
last two, I think, have no drug potential. If I know Washington bureucrats, KI will never be banned, unless they want their childrens' thyroids
toasted with fallout during a bombing.
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Nerro
National Hazard
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Registered: 29-9-2004
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NI3 is pretty stupid for as far as uses for I2 go. They are much more usefull for doing things like catalysing grignard reactions etc.
About being on lists, It's pretty likely that every member here has been added to a bunch of government lists by now. As if a password on whimsy would
keep the gov's back. Echelon probably took less time to figure it out than we need to type it!
#261501 +(11351)- [X]
the \"bishop\" came to our church today
he was a fucken impostor
never once moved diagonally
courtesy of bash
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Sandmeyer
National Hazard
Posts: 784
Registered: 9-1-2005
Location: Internet
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Mood: abbastanza bene
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Haha, let's face it - the empire is powered by Methedrine (TM).
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S.C. Wack
bibliomaster
Posts: 2419
Registered: 7-5-2004
Location: Cornworld, Central USA
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Mood: Enhanced
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Final rule effective 3 weeks from now:
[For some reason the site is not sending me "final rule.pdf", but "final". Save to disk and add .pdf to file name if this happens to you too.]
[Edited on 9-7-2007 by S.C. Wack]
Attachment: final rule.pdf (136kB)
This file has been downloaded 1074 times
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evil_lurker
National Hazard
Posts: 767
Registered: 12-3-2005
Location: United States of Elbonia
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Mood: On the wagon again.
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What a fucking crock of shit regulation.
Don't the idiots at the DEA know that iodide salts can easily be used to make elemental iodine?
Not all chemicals are bad. Without chemicals such as hydrogen and oxygen, for example, there would be no way to make water, a vital ingredient in
beer.
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not_important
International Hazard
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Registered: 21-7-2006
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| Quote: | Originally posted by evil_lurker
Don't the idiots at the DEA know that iodide salts can easily be used to make elemental iodine? |
Yes, they do. That's next, ask an Australian.
All the regulations are done to target the current "top threat" Move something into a tightly controlled category, and something else takes its place.
Soon candidates for political office will be arguing for tighter controls on the replacement substance, and the cycle repeats.
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DerAlte
National Hazard
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Location: Erehwon
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Evil_lurker puts it succinctly above. But I am perfectly sure that both the DEA and the professional illicit drug makers have expert chemists who are
perfectly aware that iodides can make iodine – even high school chemistry students do. Methamphetamine is so easy to make that a cottage industry
has grown up in every state. The big boys will not be inconvenienced. Ban HI? Make it in situ. Ban red P and I? reduce an iodide. Ban iodides? Ban the
element in any compound? (Ban = declare a controlled substance). The big boys don’t go buying pseudoephedrine pills from your friendly local
pharmacist, either. They import it by the ton from China. Cheap. The little guys blow themselves up.
The entire DEA paradigm is flawed. The origins of the current policy stem from good old maryjane, labeled as the gateway to the hard stuff. A plant
that grows wild from southern Chile right up into Canada, all over Africa, most of Europe and Asia. Of ancient usage in the east and far east. If you
haven’t watched Reefer Madness, you missed a hilarious Hollywood “C” comedy that today looks like a satire – a cult favorite.
Whenever you restrict a substance you increase its value, especially on the street. That makes the addicts antsy. If the price goes out of their
range, they resort to crime to get the dough they need… A vicious cycle. Amphetamines are not new. When I was a kid they were called Bennies, and a
few used them at college under the mistaken impression they made you more alert for exams. Hyper, more likely – a swift route to drop-out status.
Prohibition was tailor made for organized crime. ‘Just say no’ to a kid and he thinks you’re pulling an adult fast one on him, especially if
he’s a bit dim and street ‘wise’. There must be a point to the crap! Drug education may help if it’s lurid and graphic enough. ‘But you
can’t show that to kids – it’s just too horrible…’
Trying to restrict every precursor and precursor’s precursor is impossible. Where do you stop? As my father used to say, a clever chemist can make
anything, and the big boys hire good chemists. The garage outfits read the Web, and some renegade is bound to come up with a new process on some site
or another. Bureaucracy makes its living by rule making. Nobody ever told them to use common sense.
Regards,
DerAlte
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roamingnome
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considering that scientific discovery is the knife edge that our society follows... i.e we are all useing electricity now...
dont these fools know that techniques are coming of age.. from laser beams to mail order genetic tools
that 2% iodine isnt going to make a lick o difference on any conceivable level....
i bet they are still useing blackberries... its the iphone people
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JustMe
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This just makes me feel so sick. It is hard for me to imagine the difficulties one has to go through for chemistry to be a hobby. I mean I remember
when it was my hobby back around 1968-71 and I could go to a local laboratory supply company and buy almost anything. Between that and photography
shops one could put together a really good lab.
My heart goes out to the modern day chemistry hobbiest - I don't think I could do it... well, I guess if I was so inclined, I'd probably rely heavily
on eBay. Gentlemen, I feel your pain. 
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