BILL ANALYSIS
SENATE COMMITTEE ON PUBLIC SAFETY
Senator Mark Leno, Chair A
2009-2010 Regular Session B
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AB 1455 (Hill) 5
As Amended June 14, 2010
Hearing date: June 22, 2010
Health & Safety Code
JM:mc
PSEUDOEPHEDRINE AND RELATED PRODUCTS:
SALES LIMITS AND ELECTRONIC TRACKING OF SALES
HISTORY
Source: Consumer Healthcare Products Association; California
State Sheriffs' Association
Prior Legislation:SB 484 (Wright) - 2009, failed passage in
Assembly Public Safety
SB 276 (Vasconcellos) - Ch. 276, Stats. 2003
AB 154 (La Suer) - Ch. 13, Stats. 2001
AB 162 (Runner) - Ch. 978, Stats. 1999
Support: Shasta County Sheriff; San Bernardino County Sheriff;
Tuolumne County Sheriff; Chief Probation Officers of
California; California Probation, Parole and
Correctional Association; California Law Enforcement
Association of Record Supervisors; Mariposa County
Sheriff-Coroner; Butte County Sheriff; Humboldt County
Sheriff; El Dorado County Sheriff-Coroner; Alameda
County Sheriff; Del Norte County Sheriff; Mono County
Sheriff; Napa County Sheriff; Nevada County Sheriff;
Bayer Health Care; California Chamber of Commerce;
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Amador County Sheriff; Sacramento County Sheriff; Rite
Aid; San Bernardino County Sheriff; Santa Barbara
County Sheriff; Santa Cruz County Sheriff; California
Peace Officers Association (if amended); Molina
Healthcare; California Healthcare Institute; California
Manufacturing & Technology Association; California
Society of Health-System Pharmacists; California
Retailers Association; Pfizer; Johnson & Johnson;
California District Attorneys Association (in concept);
sanofi-aventis; Peace Officers Research Association of
California
Opposition:American Civil Liberties Union (unless amended);
Privacy Right Clearinghouse (unless amended); Oregon
State Sheriffs Association; Oregon District Attorneys
Association; Oregon Association of Chiefs of Police;
Oregon Narcotics Enforcement Association; Oregon
Alliance for Drug Endangered Children; Oregon
Methamphetamine Task Force; National Narcotic Officers
Association Coalition; Kentucky Narcotics Officers
Association; California Public Defenders Association
Assembly Floor Vote: No longer relevant
KEY ISSUES
SHOULD CALIFORNIA LAW CONFORM TO FEDERAL LAW PROVIDING THAT A
PERSON IN AN OVER-THE-COUNTER TRANSACTION MAY BUY NO MORE THAN 3.6
GRAMS OF PSEUDOEPHEDRINE OR A RELATED PRODUCT IN A SINGLE
TRANSACTION AND NO MORE THAN 9 GRAMS IN ANY 30-DAY PERIOD?
SHOULD ANY PURCHASER OF PSEUDOEPHEDRINE OR RELATED PRODUCTS BE
REQUIRED TO PROVIDE VALID PHOTO IDENTIFICATION AND SIGN A PAPER OR
ELECTRONIC LOG THAT RECORDS THE TRANSACTION DATE, AMOUNT OF THE
PRODUCT PURCHASED AND THE NAME AND ADDRESS OF THE PURCHASER?
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SHOULD SALES OF SUCH PRODUCTS BE TRACKED THROUGH AN ELECTRONIC
RECORDING SYSTEM THAT IS AVAILABLE TO LAW ENFORCEMENT AND RETAINED
BY THE RETAILER FOR NO MORE THAN TWO YEARS?
SHOULD RETAILERS BE REQUIRED TO CONFIRM THROUGH THE TRACKING SYSTEM
THAT THE SALE OF PRODUCT DOES NOT EXCEED STATUTORY LIMITS?
SHOULD VIOLATION BY A RETAILER OF THE GRAM-WEIGHT LIMITS OR SALES
PROCEDURES BE A MISDEMEANOR, WITH A FINE OF UP TO $10,000, FOR
REPEATED CONVICTIONS?
SHOULD RETAILERS BE SUBJECT TO SPECIFIED CONFIDENTIALITY RULES AND
BE LIABLE FOR MONEY DAMAGES AND AN ADMINISTRATIVE FINE FOR NEGLIGENT
USE OR HANDLING OF THE DATA?
SHOULD THE CALIFORNIA DEPARTMENT OF JUSTICE BE DIRECTED TO
CONCLUDE A MEMORANDUM OF UNDERSTANDING WITH THE NATIONAL
ASSOCIATION OF DRUG DIVERSION INVESTIGATORS, OR A SIMILAR
ENTITY, TO PROVIDE RETAILERS WITH ACCESS TO AN ELECTRONIC SYSTEM
FOR RECORDING SALES OF PSEUDOEPHEDRINE OR RELATED PRODUCTS?
PURPOSE
The purposes of this bill are to 1) specifically provide in
California law that retail sales of pseudoephedrine and related
products to a single customer are limited to 3.6 grams per
transaction and 9 grams in any 30-day period; 2) require the
purchaser to provide a valid photo identification and sign a
paper or electronic log reflecting the person's identity and the
amount and date of the purchase; 3) require retailers to record
this information in an electronic tracking system and to inform
purchasers that the information will be provided to law
enforcement to prevent illegal sales; 4) require retailers in
selling the product to access the tracking system; 5) forbid
sales that violate the gram weight limits and identification
requirement; 6) direct the Department of Justice (DOJ) to enter
into memorandum of understanding with the National Association
of Drug Diversion Investigators, or a similar entity, so as to
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allow retailers to have access to the tracking system; 7)
provide that neither the state nor DOJ shall bear any costs for
the development, installation or maintenance of the system; 8)
provide that the state shall impose no fee on a retail
distributor or manufacturer to defray costs for oversight or use
of the system; 9) provide that pseudoephedrine sales data shall
be subject to specified confidentiality rules for medical
records; 10) provide that retail distributors shall maintain the
data no longer than two years; and 11) state legislative
findings that a law enforcement investigation from a single
transaction in violation of purchase limits shall be supported
by probable cause.
Existing law , with specified and detailed exceptions, prohibits
disclosure of medical information without the authorization of
the patient. Medical information shall be disclosed pursuant to
a court order or a warrant issued to a law enforcement agency.
Other specific exceptions are enumerated. (Civ. Code 56.10.)
Existing law provides that medical information can be disclosed
"when otherwise specifically required by law." (Civ. Code
56.10, subd. (b)(9).)
Existing provisions of the California Constitution state that
all people have inalienable rights, including the right to
pursue and obtain privacy. (Cal. Const. Art. I, 1.)
Existing law classifies controlled substances in five schedules
according to their dangerousness and potential for abuse.
(Health & Saf. Code 11054-11058.)
Existing law includes the CURES (Controlled Substance
Utilization Review and Evaluation System) system to provide for
the electronic monitoring of the prescribing and dispensing of
Schedule II, III and IV controlled substances. CURES provides
for the electronic transmission of Schedule II, III and IV
prescription data to the Department of Justice (DOJ) at the time
prescriptions are dispensed. (Health & Saf. Code 11165.)
Existing law provides that pharmacists, in filling a controlled
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substance prescription, shall provide to DOJ the patient's name,
date of birth, the name, form, strength and quantity of the
drug, and the pharmacy name, pharmacy number and the prescribing
physician information. (Health & Saf. Code 11165, subd. (d).)
Existing law provides that a licensed health care practitioner
eligible to prescribe Schedule II, III or IV controlled
substances, or a pharmacist, may make a written request to the
DOJ for the history of controlled substances dispensed to an
individual based on the data in CURES. (Health & Saf. Code
11165.1, subd. (a).)
Existing law provides that the DOJ may initiate the referral of
the history controlled substances dispensed to an individual,
based on the CURES data, to licensed health care practitioners
and pharmacists, as specified. (Health & Saf. Code 11165.1,
subd. (b).)
Existing law provides that the history of controlled substances
dispensed to a patient based on CURES data that is received by a
practitioner or pharmacist shall be considered medical
information, as specified. (Health & Saf. Code 11165.1, subd.
(c).)
Existing law provides that prescriptions for controlled
substances must be made on special security forms to prevent
copying or forgery of prescriptions. (Health & Saf. Code
11162.1.)
Existing law requires practitioners other than pharmacists who
prescribe or administer a controlled substance classified in
Schedule II to make a record containing the name and address of
the patient, date, and the character, name, strength, and
quantity of the controlled substance prescribed, as well as the
pathology and purpose for which the controlled substance was
administered or prescribed. (Health & Saf. Code 11190, subd.
(a)-(b).)
Existing law requires prescribers who are authorized to dispense
Schedule II, III or IV controlled substance in their office or
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place of practice to record and maintain information for each
such prescription that includes the patient's name, address,
gender, and date of birth, prescriber's license and license
number, federal controlled substance registration number, state
medical license number, NDC number of the controlled substance
dispensed, quantity dispensed, diagnosis code, if available, and
original date of dispensing. This information shall be provided
to DOJ on a monthly basis. (Health & Saf. Code 11190 subd.
(c).)
Existing law includes a detailed regulatory scheme for the
production and distribution of specified chemicals that may be
precursors to controlled substances. (Health & Saf. Code
11100.)
Existing law provides that producers and users of precursor
chemicals (Health & Saf. Code 11100) must obtain a permit from
DOJ. Applications for permits must include documentation of
legitimate uses for regulated chemicals. (Health & Saf. Code
11106.)
Existing law provides that "[s]elling, transferring, or
otherwise furnishing or obtaining any [restricted] substance
specified in subdivision (a) of [Health & Saf. Code] Section
11100 without a permit is a misdemeanor or a felony." (Health &
Saf. Code 11106, subd. (j).)
Existing law provides that any person or entity that sells or
transfers one of a list of specified chemical precursors,
including pseudoephedrine, must obtain the purchaser's proper
identification, as specified, and a letter of authorization from
the purchaser which includes the purchaser's business license
number or DEA registration, the address of the business and a
description of how the chemical is to be used. The information
must be retained "in a readily available manner" for three
years. (Health & Saf. Code 11100, subd. (c).)
Existing law requires any person or entity that sells,
transfers, or otherwise furnishes a specified chemical
precursor to another person or entity must submit a report to
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the DOJ, generally within 21 days, of all of each
transaction. The report must include the identification
information about the purchaser. (Health & Saf. Code
11100, subd. (d).)
Existing law provides that violation of restricted chemical
reporting requirements (for transferring or obtaining restricted
chemicals) is misdemeanor. A first-time violation is punishable
by a county jail term of up to 6 months, a fine of up to 5,000,
or both. A subsequent violation is an alternate
felony-misdemeanor, punishable by a prison term of 16 months,
two years or three years for a felony, a county jail term of up
to 1 year, a fine of up to $100,000, or both such fine and
imprisonment. (Health & Saf. Code 11100, subd. (f).)
Existing law requires specified recording and tracking of
transactions involving laboratory glassware, apparatus and
chemical reagents where the value of the material exceeds $100.
The purchaser must present valid identification. The bill of
sale must be retained for 3 years, as specified. The document
must be presented to law enforcement upon request A violation
of these provisions is a misdemeanor punishable by imprisonment
in a county jail not exceeding 6 months, by a fine not exceeding
$1,000, or both. (Health & Saf. Code 11107.)
Existing law provides that it is unlawful for a retailer to (i)
sell in a single transaction more than three packages, or 9
grams, of a product that he or she knows to contain ephedrine,
pseudoephedrine, norpseudoephedrine, or phenylpropanolamine.
With specified exceptions, the three package-9 grams per
transaction limitation applies to any product lawfully furnished
over the counter pursuant to applicable federal law. This
offense is a misdemeanor, punishable by a county jail term of up
to 6 months, a fine of up to $1,000, or both. (Health & Saf.
Code 11100, subd. (g)(3).)
Existing federal law includes the Health Insurance Portability
and Accountability Act of 1996 (HIPAA) which, subject to
specified exceptions and procedures, provides that medical
information shall be confidential. (Pub. Law 104-191; 45 CFR
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160, 164.)
Existing federal law (21 USC 830 (e) and 844 (a)) -- the
Combat Methamphetamine Epidemic Act (CMEA) -- includes very
detailed restrictions and requirements the for retail sale of
ephedrine, pseudoephedrine, norpseudoephedrine or
phenylpropanolamine. These restrictions include, in part:
No more than 3.6 grams in a single transaction.
No more than 9 grams per customer in a one-month period.
If the drug is obtained through postal or similar
delivery, no more than 7.5 grams can be so obtained.
Seller must maintain a written or electronic logbook of
each sale, including the date of the transaction, the name
and address of the purchaser and the quantity sold.
The purchaser must present valid identification, as
specified, and the seller must verify the identification.
The purchaser must sign a paper or electronic logbook,
as specified.
The seller must maintain these documents, as specified.
Law enforcement shall have access to the information
pursuant to regulations adopted by the Department of
Justice.
Existing federal law provides the following penalties:
Violation of the 9 gram purchase limit is a misdemeanor.
Violation of record-keeping laws is a misdemeanor, with
specified exceptions.
Violation of the distribution limits is punishable by
imprisonment for up to five years (pursuant to the federal
sentencing guidelines).
Distribution of pseudoephedrine with knowledge that it
will be used to manufacture a controlled substance, or
intentional evasion of record keeping or reporting
requirements, is subject to imprisonment for up to 10
years, or up to 20 years, as specified. (21 USC 841 (c)
and 844 (a).)
Existing federal law includes an exception to the log book
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recording of transactions in the case of a transaction that
involves a single package that contains not more than 60
milligrams<1> of psuedoephedrine. (21 USC 841
(e)(1)(A)(iii).)
Existing federal law requires retailers to retain purchase
information for at least two years. (21 USC 841 (v)(6).)
Existing federal regulations provide the following as to the
privacy of retail pseudoephedrine transactions:
To protect the privacy of individuals who purchase
scheduled listed chemical products, the disclosure of
information in logbooks under Sec. 1314.15 is
restricted as follows:
(a) The information shall be disclosed as appropriate
to the Administration and to State and local law
enforcement agencies.
(b) The logbook information shall not be accessed,
used, or shared for any purpose other than compliance
with this title or to facilitate a product recall.
(c) A regulated seller who in good faith releases
information in a logbook to Federal, State, or local
law enforcement authorities is immune from civil
liability for the release unless the release
constitutes gross negligence or intentional, wanton,
or willful misconduct. (21 CFR 1314.45.)
This bill repeals the existing statutory provisions for
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<1> By way of illustration, a single 12-hour extended release
allergy-decongestant tablet typically contains 120 milligrams of
pseudoephedrine.
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over-the-counter sales of pseudoephedrine<2> and related
products and replaces them with new sales limits.
This bill includes or retains an exception for pseudoephedrine
sold or provided pursuant to a prescription.
This bill provides for specified procedures for the sale of
pseudoephedrine products.
This bill provides that a violation of the sales limits or
required procedures is a misdemeanor, punishable on a first
conviction by a fine of up to $1,000, a jail term of up to six
months, or both. Upon a subsequent conviction, the maximum jail
term is one year and the maximum fine is $10,000.
This bill includes the following required procedures and sales
limits:
A retailer must store pseudoephedrine products in a
locked cabinet or behind the counter.
A retailer may sell no more than 3.6 grams of
pseudoephedrine within 24 hours and no more than 9 grams in
a 30-day period.
As in federal law (CMEA), the data recording
requirements shall not apply to sale of a single package
containing no more than 60 milligrams of a product
containing pseudoephedrine.
The retailer must record the following at the time of
making a pseudoephedrine transaction:
o The date of the transaction.
o The type of identification used by the
purchaser, the agency issuing the identification and
the identification number.
o The name, date of birth and address of the
purchaser, as verified by a photo identification.
o The name of the product sold, the quantity of
packages and the total gram amount of pseudoephedrine
-----------------------
<2> Pseudoephedrine is the most commonly sold of the chemicals
or drugs covered by this bill. References to pseudoephedrine
alone in this analysis include the other chemicals covered by
the terms of this bill. - ephedrine, norpseudoephedrine or
phenylpropanolamine
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involved in the sale.
o The name or initials of the person making the
sale.
The retailer shall immediately transmit the information
about the sale and the purchaser to the electronic
monitoring system for the purpose of determining whether or
not the sale would exceed statutory limits.
The purchaser must provide valid identification, as
specified.
The purchaser must sign a written or electronic log.
The log must reflect the following:
o Transaction date.
o The agency issuing the identification used by
the purchaser and the number of the identification.
o The name and address of the purchaser.
o The amount and kind of product sold.
This bill provides that a retailer shall not maintain a separate
copy of the transaction information, except as required by
federal data collection law.
This bill provides that in the event of a failure of the data
system that makes compliance with the data collection rules in
this bill, sales records shall be maintained in a written log or
in alternative electronic form.
This bill requires the retailer to give notice to customers
explaining the identification and purchase data will be provided
to law enforcement pursuant to this bill and federal law.
Notice may be given electronically, in writing or through signs.
This bill provides that the retailer need not keep records of
pseudoephedrine transactions in a separate log or location from
those required by federal law.
This bill states that the Legislature finds that probable cause
is necessary before law enforcement can begin an investigation
based on a single transaction made in violation of
pseudoephedrine purchase limits.
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This bill provides that data collected on over-the-counter sales
of pseudoephedrine shall be maintained for no longer than two
years.
This bill provides retail distributors shall, pursuant to Civil
Code Section 56.101, preserve the confidentiality of the
information in the system and shall be subject to suit for
damages and an administrative penalty as authorized in Civil
Code Section 56.36.
This bill provides that the DOJ shall enter into a memorandum of
understanding with the National Association of Drug Diversion
Investigators or comparable organization to provide
pseudoephedrine retailers with access to an electronic
authorization and monitoring system.
This bill provides that law enforcement access to the database
system shall be recorded by means of a unique access code for
each person using the system. Access records shall be
maintained by DOJ.
This bill provides that the system shall provide retail
distributors with an immediate real-time alert if a person
attempts to purchase pseudoephedrine in violation of the limits
and procedures in this bill.
This bill provides that the data system shall conform to the
Federal Bureau of Investigation's Criminal Justice Information
Systems security standards and may be audited annually.
This bill provides that neither the DOJ nor any state agency
shall bear any cost for developing, installing or maintaining
the system.
This bill provides that the state shall impose no fee on a
retailer distributor or manufacturer to defray administrative or
other costs for oversight or use of the system.
This bill authorizes the department to enter into any agreement,
contract or memorandum of understanding (MOU) with any law
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enforcement agency to provide instant access to information
collected through the pseudoephedrine tracking system.
This bill provides that it shall not become operative unless all
of the following occur:
The BNE enters into an MOU with the National Association
of Drug Diversion Investigators or a comparable
organization.
The BNE determines that a "substantial" number of retail
distributors have access to the system.
180 days have passed from the date of the BNE
certification.
This bill provides that the MOU shall require that a retail
distributor's access to the database shall be limited to sales
by that distributor, and solely for complying with federal
(CMEA) or California data collection law, or to respond to an
authorized law enforcement request.
This bill preempts all local ordinances or regulations
concerning the over-the-counter sale of pseudoephedrine
products.
This bill includes the following definitions concerning sellers
of pseudoephedrine:
"Retail distributor" means a grocery store, general
merchandise store, drug store, or related entity that sells
pseudoephedrine products only for personal use to walk-in
customers or in face-to-face transaction. The parent
company of a retailer is not a retail distributor for
purposes of this bill.
"Drug store" "general merchandise store" or "grocery
store" means such an entity as described in a certain
sections of specified classification manual published by
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the U.S. Office of Management and Budget in 1987<3>.
"Sale for personal use" means a sale of pseudoephedrine
in a single transaction to an individual customer for
legitimate medical use. Sale for personal use also
includes sales to employers to be dispensed to employees
from first-aid kits or medicine chests.
This bill includes a January 1, 2017, sunset.
RECEIVERSHIP/OVERCROWDING CRISIS AGGRAVATION
The severe prison overcrowding problem California has
experienced for the last several years has not been solved. In
December of 2006 plaintiffs in two federal lawsuits against the
Department of Corrections and Rehabilitation sought a
court-ordered limit on the prison population pursuant to the
federal Prison Litigation Reform Act. On January 12, 2010, a
federal three-judge panel issued an order requiring the state to
reduce its inmate population to 137.5 percent of design capacity
-- a reduction of roughly 40,000 inmates -- within two years.
In a prior, related 184-page Opinion and Order dated August 4,
2009, that court stated in part:
"California's correctional system is in a tailspin,"
the state's independent oversight agency has reported.
. . . (Jan. 2007 Little Hoover Commission Report,
"Solving California's Corrections Crisis: Time Is
Running Out"). Tough-on-crime politics have increased
the population of California's prisons dramatically
while making necessary reforms impossible. . . . As a
result, the state's prisons have become places "of
extreme peril to the safety of persons" they house, .
. . (Governor Schwarzenegger's Oct. 4, 2006 Prison
Overcrowding State of Emergency Declaration), while
contributing little to the safety of California's
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<3> Codes 5912, 5311 to 5319 and 5411 (drug store, general
merchandise store and grocery store respectively) of the
Standard Industrial Classification Manual of the Office of
Management and Budget, 1987 edition
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residents, . . . . California "spends more on
corrections than most countries in the world," but the
state "reaps fewer public safety benefits." . . . .
Although California's existing prison system serves
neither the public nor the inmates well, the state has
for years been unable or unwilling to implement the
reforms necessary to reverse its continuing
deterioration. (Some citations omitted.)
. . .
The massive 750% increase in the California prison
population since the mid-1970s is the result of
political decisions made over three decades, including
the shift to inflexible determinate sentencing and the
passage of harsh mandatory minimum and three-strikes
laws, as well as the state's counterproductive parole
system. Unfortunately, as California's prison
population has grown, California's political
decision-makers have failed to provide the resources
and facilities required to meet the additional need
for space and for other necessities of prison
existence. Likewise, although state-appointed experts
have repeatedly provided numerous methods by which the
state could safely reduce its prison population, their
recommendations have been ignored, underfunded, or
postponed indefinitely. The convergence of
tough-on-crime policies and an unwillingness to expend
the necessary funds to support the population growth
has brought California's prisons to the breaking
point. The state of emergency declared by Governor
Schwarzenegger almost three years ago continues to
this day, California's prisons remain severely
overcrowded, and inmates in the California prison
system continue to languish without constitutionally
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adequate medical and mental health care.<4>
The court stayed implementation of its January 12, 2010, ruling
pending the state's appeal of the decision to the U.S. Supreme
Court. On Monday, June 14, 2010, the U.S. Supreme Court agreed
to hear the state's appeal in this case.
This bill does not appear to aggravate the prison overcrowding
crisis described above.
COMMENTS
1. Need for This Bill
According to the author:
AB 1455 implements a statewide electronic tracking in
retail outlets to monitor all over-the-counter (OTC)
pseudoephedrine (PSE) purchases in real-time to
prevent "smurfing" where criminals go from
store-to-store attempting to exceed the legal purchase
limits established in federal law.
Methamphetamine is a powerful psychostimulant drug
that impacts the central nervous system, is highly
addictive, and can be synthesized with a basic
understanding of chemistry from chemicals that are
commonly available to consumers. In 2008, law
enforcement in California seized 119 methamphetamine
labs, including 15 super labs that have the capability
of producing more than ten pounds. A principal
ingredient in clandestine methamphetamine production
is pseudoephedrine/ephedrine and its isomers and/or
----------------------
<4> Three Judge Court Opinion and Order, Coleman v.
Schwarzenegger, Plata v. Schwarzenegger, in the United States
District Courts for the Eastern District of California and the
Northern District of California United States District Court
composed of three judges pursuant to Section 2284, Title 28
United States Code (August 4, 2009).
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salts, which are also common decongestant ingredients
in many OTC cold and allergy medications.
Federal law regulates the retail sale of PSE products.
The laws prohibit sale of more than 3.6 grams in a
single transaction, and more than 9.0 grams in a
one-month. A seller must maintain a written or
electronic log of each sale, including the transaction
date, name and address of the purchaser, and the
quantity sold. A purchaser must present valid
identification, verified by the seller. The purchaser
must sign a paper or electronic logbook that must be
maintained by the seller. California retailers comply
with federal law, but the records are not coordinated.
AB 1455 centralizes this information and makes it
available in real-time.
The electronic tracking system will be funded by
industry and administered by the National Association
of Drug Diversion Investigators (NADDI), which will
support the database. The state Department of Justice
will enter into a Memorandum of Understanding with
NADDI to ensure appropriate access to the system for
retailers, and access for law enforcement. Retailers
cannot access database information; they only input
information into the system. Law enforcement is the
only entity with access to the information in the
database.
When a consumer seeks to purchase any OTC
PSE-containing product from a retailer, the retailer
will be required to input the federally-mandated
consumer information into the electronic database.
Retailers will access the system through either a
web-based interface, where the only requirement is a
computer with internet access, or direct interface
with the database. The system will instantly
electronically alert the retailer if the consumer is
about to purchase amounts in excess of the amounts
authorized by law. If an alert is received by the
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retailer, the sale cannot be made. Any retailer
making a sale without entering the information into
the central database through this system, or making a
sale notwithstanding an alert, will be subject to
prosecution for a misdemeanor. A second conviction is
punishable by up to one year in county jail and a
$10,000 fine.
2. Restrictions on Pseudoephedrine in Other States
According to the 2010 Drug Threat Assessment by the U.S.
Department of Justice, 45 states have enacted limits on
purchases of pseudoephedrine. Laws vary in other states. (2010
Threat Assessment, USDOJ., pp. 66-67.) Twenty states have made
pseudoephedrine a scheduled drug (controlled substance),
although most of those states create an exception for over the
counter sales consistent with federal law. Forty-three states
have imposed point-of-sale restrictions, and 26 have enacted
pseudoephedrine tracking laws. (Ibid.)
Oregon has required a prescription for pseudoephedrine purchases
since 2006. Mississippi will require a prescription in July,
2010.
According to the sponsor, the following states have electronic
tracking of pseudoephedrine sales: Alabama, Arkansas, Florida,
Illinois, Iowa, Kansas, Kentucky, Louisiana, Missouri, Oklahoma,
South Carolina, and Washington. (See Comment # 18 for a
discussion of Oregon's experience with reduced methamphetamine
laboratory incidents.)
3. Standard Packages of Pseudoephedrine - How Much are 3.6 Grams
and 9 Grams?
A standard pseudoephedrine tablet contains 30 milligrams. The
tablets are sold in blister packages of 24 or 28 tablets. The
recommended dose is up to two tablets every four to six hours,
but no more than eight tablets a day. This bill, as amended on
June 14, 2010, exempts from data collection requirements single
dosage packs of up to 60 milligrams.
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A box of 48 tablets contains 1440 milligrams (1.44 grams) of
pseudoephedrine. A box of 24 tablets contains 720 milligrams
(.720) grams of pseudoephedrine. Under federal law, a person
may in a single day buy no more than two boxes of 48 tablets and
a box of 24 tablets, or 120 tablets. At the recommended maximum
dose of 8 tablets per day, 3.6 grams is a 15-day supply. The
maximum monthly purchase amount - 9 grams - is approximately 306
tablets, a 38-day supply. The Mayo Clinic website warns not to
continue taking the medicine for more than 7 days if symptoms do
not improve.
Tables of Packaging, Sales Limits and Dosages<5>
-------------------------------------------------------------------
|Package |Tablet |Milligrams |Grams per |
| |weight |per |Package |
| | |Package | |
|----------------+----------------+----------------+----------------|
|48 tablets |30 |1440 |1.44 |
| |milligrams | | |
| |- .03 | | |
| |grams | | |
|----------------+----------------+----------------+----------------|
|24 tablets |30 |720 |.720 |
| |milligrams | | |
| |- .03 | | |
| |grams | | |
-------------------------------------------------------------------
-----------------------------------------------------------------
|Daily |Packages |Tablet |Maximum |
|Limit | |limit |Dosage |
|---------------+----------------+----------------+---------------|
|3.6 grams |2 packs of |120 |15 days |
| |48 tabs, | |at |
| |and | |maximum |
-------------------------
<5> These charts assume that the pseudoephedrine tablet contains
nothing but pseudoephedrine. The actual amount of the drug in a
tablet may be somewhat less than the weight of the tablet.
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AB 1455 (Hill)
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| |1 pack of | |of 8 |
| |24 tabs | |tablets |
| | | |per day |
| | | | |
-----------------------------------------------------------------
-------------------------------------------------------------------
|Monthly |Packages |Tablet |Dosage |
|limit | |limit | |
|----------------+----------------+----------------+----------------|
|9 grams |6.25 packs |300 |38 days at |
| |of 48 | |maximum of |
| | | |8 tabs per |
| | | |day |
| | | | |
-------------------------------------------------------------------
4. Funding for and Development of the Electronic Tracking System
This bill specifically states which entities will not pay for
the electronic tracking system. Those entities include the
state generally and the California Department of Justice
specifically. The bill does not provide who will pay for the
system and how the funds will be collected.
Representatives of the sponsor have stated that manufacture
(including those who re-label products as their own) will pay
for the system. The sponsor's representatives also stated that
retailers would need no more than an Internet connection to
access the system. No special equipment would be necessary, and
a retailer will not be charged to access the system. Chain
drugstores, could adapt existing electronic systems into the
database.
Kentucky received a grant from the federal COPS program of over
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AB 1455 (Hill)
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$564,000 for the "Methcheck" program for 2008-2010 budget cycle.
SHOULD A PRIVATE CONTRACTOR OPERATE A DATABASE OF PERSONAL
INFORMATION THAT IS USED TO DETERMINE IF A PROSPECTIVE
OVER-THE-COUNTER SALE OF PSEUDOEPHEDRINE IS LEGAL?
5. National Association of Drug Diversion Investigators (NADDI)
The bill essentially provides that the National Association of
Drug Diversion Investigators (NADDI) would reach an MOU with the
state DOJ to develop the tracking system. The system could not
be activated until certified by DOJ.
NADDI (est. 1989) is a national non-profit organization that,
according to its website, "facilitates cooperation between law
enforcement, healthcare professionals, state regulatory agencies
and pharmaceutical manufacturers in the investigation and
prevention of prescription drug abuse and diversion. NADDI also
sponsors and conducts specialized educational seminars and
conferences." NADDI is based Maryland. The association has 21
state chapters, including California.
WHICH ENTITIES WILL ACTUALLY PAY FOR THE DEVELOPMENT, OPERATION
AND MAINTENANCE OF THE ELECTRONIC TRACKING SYSTEM, AND HOW WILL
FUNDS BE COLLECTED AND APPLIED?
IF THE TRACKING SYSTEM IS NOT CERTIFIED BY THE DEPARTMENT OF
JUSTICE, WHAT LAWS AND REGULATIONS WILL GOVERN THE RETAIL SALE
OF PSEUDOEPHEDRINE?
6. Privacy Concerns from Recording Pseudoephedrine Sales in a
Database that can be Accessed by Law Enforcement and
Pseudoephedrine Retailers
California law includes relatively stringent medical privacy
rules. Unless a specified exception applies, such as a court
order or warrant, medical information can only be disclosed with
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the authorization of the patient. The federal Health Insurance
Portability and Accountability Act of 1996 (HIPAA) rules also
require confidentiality of medical information, with specified
exceptions. It appears that HIPAA controls over any conflicting
state laws.
Covered entities may disclose protected health information (not
pseudoephedrine sales) to law enforcement officials for
specified law enforcement purposes, such as court orders, to
identify suspects or witnesses, to find missing persons,
information about a crime victim, notice of death and related
matters.
As explained above, the CMEA federal regulations grant law
enforcement great access to the information. A purchaser's
information shall be disclosed "as appropriate" to federal,
state or local law enforcement. Arguably, confidentiality is
relatively high for purposes other than law enforcement. That
is, the information shall not be accessed, used, or shared for
any purpose other than to ensure compliance with the CMEA or to
protect public health and safety in a product recall. The CMEA
regulations provide civil immunity for information released to
law enforcement. Immunity does not apply if the release
constitutes intentional misconduct or gross negligence. (21 CFR
1314.45.)
This bill requires retailers to electronically record personal
information from each person who buys pseudoephedrine or related
products. This information is then entered into a database that
can be accessed, apparently in real time, by law enforcement.
As amended on June 14, 2010, the bill provides that a retail
distributor can retain information for no more than two years,
except as required under the federal CMEA. The retailer may not
keep a copy of the information, except as required by federal
law.
The recent amendments also make a retail distributor's use of
the system subject to Section 56.101 of the Civil Code, which
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AB 1455 (Hill)
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provides that a health care provider, health plan,
pharmaceutical company, or contractor that creates, uses, stores
or maintains, or destroys medical records shall preserves the
confidentiality of the information in the records. Negligence
as to medical records by an entity subject to Section 56.101 is
liable, pursuant to Section 56.36, for an administrative penalty
and a suit for money damages.
IS CONFIDENTIALITY OF PURCHASER INFORMATION PROTECTED BY
PROHIBITING A RETAIL DISTRIBUTOR FROM RETAINING THE INFORMATION
FOR MORE THAN TWO YEARS, BY SUBJECTING A NEGLIGENT RETAILER TO
SUIT AND AN ADMINISTRATIVE FINE, AND BY A PROHIBITION ON COPYING
THE INFORMATION?
DOES THE BILL ADEQUATELY LIMIT THE LENGTH OF TIME THAT THE
PRIVATE VENDOR OR LAW ENFORCEMENT CAN RETAIN THE DATA?
Federal law requires retailers to record the same information as
is required by this bill, and federal law provides that the
information can be electronically recorded. However, federal
law does not include a single database into which all
transactions are recorded. According to a July, 2007 story
published by MSNBC about the Kentucky tracking law, privacy
advocates raised concerns about a system through which law
enforcement<6> can access data about drug store customers. The
advocates stated that the vast majority of pseudoephedrine
purchases are legitimate and that there was no reason for law
enforcement to information about people making such purchases.
Law enforcement representatives responded that the system is
simply an investigative tool, and does not provide probable
---------------------------
<6> Representatives of the sponsor submit that the data already
in the system would not be accessible to a retail clerk. (This
appears to be based on the experience of the Appriss Company
system used in Kentucky.) The only information provided by the
system to the clerk at the time of a sale is whether or not a
sale is prohibited. The system does not reveal the reason for
the prohibition. The clerk would give the customer a number to
call for an explanation of the denial of sale.
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AB 1455 (Hill)
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cause for search or arrest.
Arguably, law enforcement has no use for any information in the
system except where a sale has been denied or the prospective
purchaser presented a questionable identification. Perhaps
privacy concerns could be limited if the bill specified the
circumstances under which law enforcement could obtain access to
information in the database.
The bill apparently does not limit the time law enforcement can
retain the information. This raises the issue whether or not
some other law limits the time law enforcement, or the entity
operating the database, may retain the information.
SHOULD THE BILL SPECIFICALLY PROVIDE THAT LAW ENFORCEMENT MAY
OBTAIN DATA FROM THE TRACKING SYSTEM ONLY WHERE A PERSON
ATTEMPTED TO PURCHASE PSEUDOEPHEDRINE IN VIOLATION OF STATUTORY
LIMITS OR THE PERSON USED AN APPARENTLY INVALID IDENTIFICATION?
ARE PRIVACY AND ABUSE CONCERNS LIMITED BY THE REQUIREMENT THAT
EACH LAW ENFORCEMENT OFFICER MUST ACCESS THE DATABASE WITH A
UNIQUE IDENTIFIER THAT SHALL BE RETAINED AND MAY BE AUDITED BY
DOJ?
7. Notice to Purchasers that Their Information will be Provided
to Law Enforcement
As amended on June 14, 2010, the bill requires a retailer to
give notice - electronically, in writing or by signs - that the
purchaser's information will be provided to law enforcement so
as to determine the legality of the transaction under California
law and the federal CMEA. Privacy advocates have argued that
such a notice is necessary and reasonable.
Under existing law, physicians do prescribe pseudoephedrine; and
pharmacies supply the drug without recording the transactions in
the log book (paper or electronic) required by federal law for
over-the-counter sales. California law currently exempts
prescription dispensation of pseudoephedrine from
over-the-counter sales limits. It appears that prescriptions
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AB 1455 (Hill)
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will also not be subject to the reporting requirements in this
bill. (Health & Saf. Code 11100, subd. (e).)
It can be argued that a person should also be informed that the
drug is available by prescription and that such transaction are
not subject to the data collection rules. Giving consumers
reasonable notice that pseudoephedrine is available by
prescription could ease privacy concerns.
SHOULD CONSUMERS BE INFORMED THAT THEY MAY OBTAIN
PSEUDOEPHEDRINE BY PRESCRIPTION WITHOUT BEING ENTERED IN THE
DATABASE FOR OVER-THE-COUNTER SALES?
WOULD ANY PRIVACY PROBLEMS CREATED BY THE NEW DATABASE MAINLY
AFFECT CONSUMERS WHO CANNOT AFFORD A PRESCRIPTION FOR
PSEUDOEPHEDRINE?
8. Probable Cause Concerning Investigations Based on a Single
Prohibited Transaction
As amended on June 14, 2010, the bill provides the following:
"The Legislature finds [that probable cause is required] to
trigger an investigation in connection with an individual whose
requested purchase is denied a single time." This is an unusual
construction. Ordinarily, a probable cause requirement would be
stated directly.
The California Constitution provides that admissibility of
evidence that a criminal defendant argues was seized illegally
is determined by the federal constitution. (In re Lance W.
(1985) 37 Cal.3d 873.) In the context of this bill, where a
defendant argues that the police did not have probable cause to
investigate him or her based on a single purchase denial, the
admissibility of evidence taken from the database (and
additional information directly flowing from that information)
would be determined under federal Fourth Amendment
constitutional law on invalid searches. If probable cause is
not required by the federal constitution under such
circumstances, the evidence would be used against the defendant.
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In discussions about this bill, representatives of the ACLU have
argued that requiring collection of pseudoephedrine purchase
data and granting law enforcement essentially unfettered access
to such information violates numerous constitutional provisions.
They have also argued that the CURES program, under which DOJ
tracks prescriptions for controlled substances, is also
constitutionally invalid or suspect. Committee counsel has not
found any cases directly challenging the federal CMEA data
tracking requirements. Nor has counsel found any cases directly
challenging the constitutionality of CURES.
WILL A LEGISLATIVE FINDING THAT PROBABLE CAUSE MUST BE
ESTABLISHED BEFORE A SINGLE PROHIBITED TRANSACTION TRIGGERS AN
INVESTIGATION HAVE ANY REAL EFFECT IN A CRIMINAL PROSECUTION?
IS THE CONSTITUTIONALITY OF FEDERAL PSEUDOEPHEDRINE DATA
COLLECTION RULES AND THIS BILL, IN ADDITION TO SIMILAR DATA
COLLECTION FOR CONTROLLED SUBSTANCE PRESCRIPTIONS, SUBJECT TO
CHALLENGE?
9. The CURES Program - Electronic Monitoring of Controlled
Substance Prescriptions, Private Contractor
The CURES program was established in 1997 by AB 3042 (Takasugi)
in response to recommendations of the Controlled Substance
Prescription Advisory Council. (SCR 74, 1992.) CURES was
initially intended to electronically monitor the prescribing and
dispensing of Schedule II controlled substances such as
oxycodone. CURES provides for real-time electronic transmission
of specified prescription data to DOJ. Essentially the data is
analyzed for indications that controlled substances are being
improperly prescribed, or that drug abusers are obtaining
prescriptions from many doctors (doctor shopping). Physicians
and pharmacists, in addition to law enforcement, have access to
CURES data through PAR - patient activity reports. A private
contractor - Infinite Solutions Inc. (ISI) - collects CURES data
for DOJ.
DOES THE EXISTING CURES SYSTEM USE EXTENSIVE REAL-TIME DATA
TRACKING AND MONITORING OF CONTROLLED SUBSTANCE PRESCRIPTIONS
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AND PATIENTS?
10. Decongestant Medications - Efficacy Comparisons
Many consumers rely on pseudoephredine products to ease nasal
congestion because these products are effective. Because one
does not need a prescription to buy them, these medications are
readily available to those without medical insurance or access
to physicians for non-emergency treatment.
In recent years, because of restrictions on the sale and
distribution of pseudoephredine, the pharmaceutical industry has
developed and marketed alternative or substitute products.
These substitute decongestants are kept on open shelves in drug
stores and other retail shops, while pseudoephedrine products
must be kept behind the counter or in a locked cabinet. It
appears that the most commonly used substitute is phenylephrine.
A recent article by Gayle Nicholas Scott, Pharm. D.,<7> reviewed
the relative efficacies of pseudoephredine and phenylephrine.
Dr. Scott concluded: "Phenylephrine appears to have less
decongestant activity than pseudoephedrine ." She also noted
that phenylephrine has a shorter half-life than pseudoephedrine
thus requiring more frequent use.
WOULD THIS BILL ALLOW THOSE WITHOUT LIMITED ACCESS TO
PHYSICIANS, OR LIMITED FUNDS FOR TREATMENT, TO OBTAIN AN
EFFECTIVE MEDICATION WITHOUT A PRESCRIPTION?
DOES THE AVAILABILITY OF PRESCRIPTIONS FOR PSEUDOEPHEDRINE LIMIT
PRIVACY CONCERNS ABOUT THE DATABASE?
11. New "Shake and Bake" or "One-Pot" Method for Making Small
Batches of Methamphetamine
---------------------------
<7> Dr. Scott wrote the article as a consultant to Sportpharm, a
company that supplies medical supplies and drugs to athletic
organizations. Sportpharm is relied upon by organizations such
as USA Track and Field, the national governing body for track
and field, including anti-doping issues.
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Recent media and law enforcement reports have noted that a new
process for making methamphetamine on a small scale is rapidly
growing in popularity. This process is typically called "shake
and bake" or "one pot" because the drug is usually made in a
2-liter bottle or a similar closable container and typically
produces an amount for personal use. This method requires much
less pseudoephedrine than required to make methamphetamine in a
full clandestine lab. Nevertheless, as with the full laboratory
method, the one pot method is very dangerous. The chemicals can
explode and even create fireballs.
The shake and bake method essentially involves mixing crushed
pseudoephedrine tablets, a substance such as ammonia nitrate
(which can be found in instant cold packs for icing injuries),
lithium battery strips, drain cleaner (or similar product) and
water. The materials create a chemical reaction in a single
bottle. Recipes typically call for about 200 tablets of
pseudoephedrine. This amount falls within the monthly legal
limit.
WILL THE "SHAKE AND BAKE" OR "ONE POT" METHAMPHETAMINE METHOD,
WHICH USES RELATIVELY SMALL AMOUNTS OF PSEUDOEPHEDRINE, MAKE IT
MORE DIFFICULT TO PREVENT DIVERSION OF PSEUDOEPHEDRINE?
12. U.S. DOJ Attributes Rise in Laboratory Discoveries to
Development and Increase in the One-Pot, Small-Scale
Cooking Method
The 2010 Methamphetamine Threat Assessment published by the U.S.
DOJ National Drug Intelligence Center noted that an increasing
proportion of "laboratory" seizures or incidents result from
one-pot or shake and bake manufacturing:
Domestic methamphetamine laboratory seizures increased
from 3,096 laboratories in 2007 to 3,950 in 2008 to
5,308 in 2009 (see Figure 3 on page 5). Analysis of
laboratory seizure data indicate that the increase-71
percent since 2007-primarily is due to an increase in
the prevalence of small-scale "one pot," or "shake and
bake," lithium ammonia method laboratories (see text
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box). In fact, of the small-scale laboratories seized
between 2007 and 2009, the number of small-scale
lithium ammonia method laboratories increased 158
percent overall- from 1,583 in 2007 to 2,584 in 2008
to 4,089 in 2009.
Domestic superlab seizures did not change
significantly during this period. The number of
superlabs [capable of producing 10 lbs. or more of the
drug in a cycle] seized increased only slightly from
2007 (11) to 2008 (17) before decreasing in 2009 (14).
? 13 [superlabs] were seized in California and one in
Georgia. Rising methamphetamine production in 2009 was
realized in six of the nine Organized Crime Drug
Enforcement Task Force regions, with the most notable
increase occurring in the Great Lakes Region ? [T]he
total number of ?laboratories seized in the [region] ?
increased 62 percent, from 1,012 in 2008 to 1,640 in
2009. Of the 1,640 reported laboratories seized in
the region in 2009, most (1,332) were capable of
producing only 2 ounces or less of methamphetamine per
production cycle.
It appears that one-pot cooking may create less danger to the
public than traditionally cooking methods that create relatively
large quantities of toxic chemicals. An August 2009, AP story
stated that the one-pot methods produces enough for only a "few
hits." While there is substantial danger that a one-pot or soda
bottle used to make a small batch of methamphetamine could
explode, the danger appears to mainly be to the cooker and
persons in the immediate vicinity. However, the AP report noted
that the explosive power of one-pot cooking can cause
particularly intense fires, including a fire in an apartment.
Traditional cooking methods created a risk of explosion of the
building where the cooking took place. There have been reports
of entire apartments exploding. (WKRG.com, Mobile-Pensacola,
July 7, 2009.) In addition, traditional methods produce
relatively large amounts of waste chemicals that are abandoned
at the manufacturing site or dumped into the environment.
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Children are particularly subject to contamination by
methamphetamine manufacturing. The toxic residue from a one-pot
recipe is typically left in a 2-liter soda bottle.
The federal DOJ has reported that superlabs (at least 10 lb.
capacity per cycle) are still being discovered in California and
that superlabs have used smurfed pseudoephedrine. Nevertheless,
the one-pot or shake and bake method appears to present less
danger to the public and the environment than large-scale
operations.
DO MANY OF THE METHAMPHETAMINE LABORATORIES FOUND IN RECENT
YEARS REFLECT GROWING USE OF THE SMALL-SCALE ONE-POT OR SHAKE
AND BAKE METHOD?
13. Concerns over Continuing Demand for Methamphetamine;
Involvement of Drug Trafficking Organizations, or Cartels, in
Methamphetamine Trafficking
As long as demand for the drug is high, eliminating California
manufacturing of methamphetamine will not diminish use of the
drug if the drug remains available from others sources,
especially Mexico. Any policy change that results in an
increase in importation of methamphetamine from Mexico, even a
law that has the substantial benefit or reducing illicit
laboratories in California, could adversely affect public
safety. Law enforcement and media sources have recently noted
an increase in violence used by Mexican drug trafficking
organizations (DTOs) in the United States, including significant
increases in violence related to Mexican DTOs in border states.
(Mexican Drug Cartel Violence Spills Over, Alarming U.S., New
York Times, March 22, 2009.)
Media and law enforcement reports noted an increase in
involvement by Mexican DTOs in the methamphetamine trade when
states across the country greatly restricted the availability of
pseudoephedrine. A January 23, 2006, article in the New York
Times entitled, "Potent Meth Floods in as States Curb Domestic
Variety," described the intended and unintended consequences of
reducing access to pseudoephedrine in Midwest states. Law
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enforcement and health officials found:
Laboratory seizures dropped dramatically (from 120 to 20
a month in Iowa);
Burn injuries from handling toxic chemicals decreased
greatly in Iowa;
Demand remained constant, and even increased among women
in Iowa;
Decreases in removal of children because parents cooked
meth was offset by an increase in removals based on
parental use;
Mexican cartels increased distribution of meth;
Methamphetamine became more potent and addictive;
Overdoses increased; and
Methamphetamine prices increased, as did burglaries, in
Iowa.
WILL MEXICAN DRUG TRAFFICKING ORGANIZATIONS MEET THE DEMAND FOR
METHAMPHETAMINE, WITH ASSOCIATED HARMS?
14. 2010 U.S. Department of Justice Methamphetamine Analysis:
Dominance by Mexican Drug Trafficking Organizations (DTOs),
Widely Available Product, Lowest Prices and Greatest Purity
Since 2005, Reduced Domestic Production and Laboratories
The U.S. Department of Justice, National Drug Intelligence
Center, publishes extensive reports about drug use and
trafficking. The DOJ/DEA reports data for each state and
publishes narrative reports for each state. The agency also
publishes an annual "threat assessment" that tracks and projects
drug trends. The overall 2010 Threat Assessment was published
in February, 2010.
The separate 2010 Threat assessment for methamphetamine was
recently published in the New York Times prior to release by the
National Drug Intelligence Center. The Times stated that the
report was likely not publicly released by the government
because of concerns over relations between the U.S. and the
government of Mexico. The Times story states that the
assessment "portrays drug cartels as easily able to circumvent
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PageF
the Mexican government's restrictions on the importing of
chemicals used to manufacture meth, which has reached its
highest purity and lowest price in the United States since
2005." (U.S. Delays Report tying Meth to Mexico, New York
Times, June 8, 2010, italics added.)
The Executive Summary of the 2010 methamphetamine threat
assessment presents a relatively pessimistic portrait of the
situation in the United States. Arguably, the only positive
conclusion in the assessment is that "[a]s Mexican ? production
increases, the need for domestic production will decrease.
Preliminary first-quarter 2010 data on methamphetamine
laboratory seizures reflect a downward trend in domestic
production - the result of restored availability of
Mexico-produce product."
The report states:
After gradually declining since 2006, domestic
methamphetamine availability is at a 5-year high as
a result of increasing large-scale production of the
drug in Mexico and, to a lesser extent, the increasing
prevalence of small-scale production in the United
States. Mid-2009 indicators, particularly increased
methamphetamine seizures along the Southwest Border
and seizures of bulk pseudoephedrine and
pseudoephedrine analogs entering Mexico, point to a
renewed ability of Mexican DTOs to acquire precursor
chemicals. This has led to resurgence in
methamphetamine production in Mexico. Moreover, the
increased use of nonephedrine-based methods of
methamphetamine production by Mexican DTOs, along with
seizures in Mexico of large-scale methamphetamine
laboratories that used nonephedrine-based production
methods, confirms increased production in Mexico.
At the same time, seizures of methamphetamine
laboratories in the United States rose for the second
year in a row, primarily because of the growing
prevalence of small-scale "onepot," or "shake and
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bake," laboratories. As a result, overall
methamphetamine availability is high and increasing,
as evidenced by supplies of the purest methamphetamine
available in U.S. markets since 2005, at prices that
currently reflect a 5-year low. As Mexican
methamphetamine production increases, the need for
domestic production will decrease. Preliminary
first-quarter 2010 data on methamphetamine laboratory
seizures reflect a downward trend in domestic
production-the result of the restored availability of
Mexico-produced methamphetamine in U.S. drug markets.
(DOJ 2010 Meth. Threat Assess., p.1, italics added.)
The amount of methamphetamine shipped into the U.S. by Mexican
DTOs in 2009 exceeded the amount shipped in 2005, the year that
pseudoephedrine restrictions began in Mexico. The amount of
methamphetamine seized along the border in 2009 was 1,000
kilograms (43%) higher than the last year in which
pseudoephedrine importation was not limited in Mexico.
The 2010 DOJ methamphetamine threat assessment attributed much
of the increase in Mexican production to the use of the P2P
(using phenyl-2-propanone) method. In contrast, the United
Nations - through the International Narcotics Control Board
(INCB) - has noted that Mexican DTOs have contracted with
pseudoephedrine manufacturers in Asia. (Precursors, INCB 2008
report, pp. 7-8.) Further, the 2009 DOJ threat assessment noted
that Mexican DTOs would have little difficulty obtaining
pseudoephedrine in Central and South America. (2009 National
Drug Threat Assessment, DEA, pp. 13-16.)
The United Nations has reported that Mexican cartels have set up
operations in Africa and the Middle East in order to obtain
methamphetamine precursors. The report stated: "Africa remains
a major area of diversion of precursors of amphetamine-type
stimulants." The final destination for these chemicals was
identified as Mexico. The report noted: "Organized criminal
groups have made use of fictitious companies and falsified
import authorizations ? [in Africa]." (Precursors, INCB 2008
report, pp. 7-8.)
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Chart - Southwest Border Seizures of Methamphetamine (Kilograms)
-------------------------------------------
|2005 |2,918 |
|---------------------+---------------------|
|2006 |2,798 |
|---------------------+---------------------|
|2007 |1,860 |
|---------------------+---------------------|
|2008 |2,201 |
|---------------------+---------------------|
|2009 |3,477 |
-------------------------------------------
TO WHAT EXTENT IS DOMESTIC METHAMPHETAMINE PRODUCTION DECREASING
AS A RESULT OF WIDELY AVAILABLE AND INEXPENSIVE METHAMPHETAMINE
PRODUCED IN MEXICO?
15. DEA Analysis of California Methamphetamine Situation
The 2008 DEA summary for the California methamphetamine
situation follows:
? Methamphetamine is the primary drug threat in
California. Mexican (DTOs) ? dominate the production
and distribution of high-quality meth, while a
secondary trafficking group, composed primarily of
Caucasians, operates small, unsophisticated
laboratories. Clandestine laboratories can be found
in any location ? In recent years, there has been a
decrease in the number of meth labs seized in
California and an increase in the number of meth labs
just south of the border in Mexico. Rural areas in
the Central Valley are the source of much of the meth
produced in California and seized elsewhere. Within
California itself, Hispanics and Caucasians are the
almost exclusive consumers of meth. ?. As the supply
of pseudoephedrine from Canada has diminished after
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PageI
successful law enforcement operations, there has been
a noticeable increase in pseudoephedrine and ephedrine
seized that originated from China. Restrictions on
pseudoephedrine importation into Mexico,
balance-of-power issues among rival Mexican cartels,
and increased [Mexican] enforcement efforts ? have all
significantly impacted methamphetamine manufacturing
and the smuggling of finished product into the Los
Angeles area.
16. California and Federal Statutes on Pseudoephedrine
Sales Limits - Smurfing to Obtain Chemicals to Make
Methamphetamine
Despite limits on purchases of pseudoephedrine, laboratory
incidents in California rose in 2008 to 346. (As noted above,
the increase in laboratory incidents could be attributable in
significant part to the use of one-pot or one container cooking
methods.) Many law enforcement agencies, including the DEA,
have concluded that the rise in laboratories in 2008 resulted
from an increase in "smurfing" of pseudoephedrine. Smurfing
involves purchases of small amounts of pseudoephedrine from
numerous drug stores. While smurfers may violate federal law in
purchasing more than 9 grams in a month - although each purchase
would not be over the 3.6 gram limit - the lack of adequate law
enforcement personnel and resources to manually review purchase
logs and absence of a database for tracking purchase or the
personnel allows smurfing to continue.
As noted above, the 2010 DOJ methamphetamine threat assessment
attributes much of the increase in laboratory incidents
nationally to the increasing use of small-batch one-pot method
of making methamphetamine.
17. Methamphetamine Lab Incidents, Pseudoephedrine Sales
Laws, Methamphetamine Threat Assessment for the Future
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DEA data on methamphetamine lab incidents<8> in California,
2003- 2208:
-----------------------------------------------------
|2003 |1,281 |
|--------------------------+--------------------------|
|2004 |767 |
|--------------------------+--------------------------|
|2005 |468 |
|--------------------------+--------------------------|
|2006 |353 |
|--------------------------+--------------------------|
|2007 |221 |
| | |
|--------------------------+--------------------------|
|2008 |346 |
-----------------------------------------------------
18. Oregon Law Requires a Prescription for
Pseudoephedrine; Prescription Proponents Attribute the Drop
in Oregon Meth Laboratories to that Law
The 2008 DEA report on drug trends in Oregon stated that
methamphetamine is readily available, potent and widely used in
Oregon. The DEA stated: "Reported clandestine laboratory
seizures have been declining, and the local drug market has been
increasingly supplied with methamphetamine from other
southwestern states and Mexico. Mexican drug trafficking
organizations dominate the methamphetamine supply in the Pacific
Northwest."
Proponents of the Oregon law that requires a prescription for
pseudoephedrine attribute the dramatic reduction of
methamphetamine laboratory incidents in Oregon to the
prescription law. They argued that the law prevents "smurfing"
---------------------------
<8> A laboratory "incident" is defined by the DEA as including
labs, dumpsites and chemical or glassware seizures. Thus, the
number of laboratory incidents does not necessarily reflect the
number of labs actually producing methamphetamine
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of pseudoephedrine through multiple over-the-counter purchases
of the drug in an amount allowed by law.
WOULD THE OREGON APPROACH BE MORE EFFECTIVE IN REDUCING THE METH
LAB PROBLEM THAN THE APPROACH PROPOSED BY THIS BILL?
WOULD THE OREGON APPROACH ADVERSELY AFFECT CONSUMERS WHO CANNOT
AFFORD A PRESCRIPTION? IF SO, WOULD ITS INTENDED BENEFITS
OUTWEIGH ITS POTENTIAL ADVERSE CONSEQUENCES?
Meth Lab Incidents in Oregon 2003-2008
-----------------------------------------------------
|2003 |419 |
|--------------------------+--------------------------|
|2004 |417 |
|--------------------------+--------------------------|
|2005 |189 |
|--------------------------+--------------------------|
|2006 |55 |
|--------------------------+--------------------------|
|2007 |22 |
| | |
|--------------------------+--------------------------|
|2008 |21 |
| | |
-----------------------------------------------------
19. Drug Demand and Treatment Issues
It has been argued that the only lasting solution for the
problems created by methamphetamine use and manufacturing is to
reduce demand through treatment. While funding for treatment
programs is very limited in these difficult economic conditions,
it is also costly to incarcerate methamphetamine offenders.
UCLA analyzes the Substance Abuse and Crime Prevention Act
(SACPA - Prop. 36 in 2000). UCLA researchers concluded that
SACPA has save $2.00 for every $1.00 spent on the program.
Where a person completed the program, every $1.00 spent saved
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$4.00. The UCLA researchers found that progress has been made
in treating methamphetamine abusers. The 2008 report concluded:
"Proposition 36 substantially reduced incarceration costs and
resulted in greater cost savings for some eligible offenders
than for others." (UCLA SACPA Report, 2008, p. 11.)
SHOULD THE STATE CONCENTRATE METHAMPHETAMINE CONTROL EFFORTS ON
REDUCING DEMAND FOR THE DRUG?
DOES STEADY DEMAND FOR METHAMPHETAMINE MAKE IT LIKELY THAT NEW
SELLERS WILL MEET THE DEMAND WHEN OTHERS ARE INCARCERATED?
20. Argument in Support
(More)
The Consumer Healthcare Products Association (CHPA), the trade
association representing U.S. manufacturers of nonprescription
medicines, argues in support:
In California today, there is no mechanism to prevent
criminals who are involved in the illegal trafficking
of PSE from buying as many packages of PSE-containing
products as they want. While federal law limits
consumers' purchases of this ingredient to 3.6 grams
per day and 9 grams in 30 days, the logbook
requirements that simply require each store to keep
sales records do not prevent determined meth cooks
from going from store to store to acquire PSE.
With NPLEx in place, retailers will obtain
pre-approval from the system to make a sale, and
over-limit sales are denied, stopping illegal sales
before they happen. The sales data are maintained in
a highly secure environment and, under federal law and
the provisions of AB 1455, are legally available only
to law enforcement. Manufacturers fully fund NPLEx,
so there is no charge to retailers, states, or law
enforcement. In the states with the most critical
meth lab problems, electronic tracking has been the
policy solution of choice for addressing PSE
diversion. Twelve states require retailers and
pharmacists to utilize a state-wide PSE sales tracking
system, including six of the ten states hardest hit by
meth labs.
Meth labs are dangerous, toxic, and costly to
remediate. Preserving access to a safe and effective
medicine, while also preventing it from falling into
the wrong hands, benefits both consumers and the State
of California. CHPA is committed to delivering an
effective PSE sales e-tracking system in California
and is pleased to offer our strong support and
endorsement for the legislation that would enable this
solution for stopping meth cooks.
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21. Argument in Opposition
The Kentucky Narcotics Officers Association (KNOA) argues that
this bill will be ineffective. The Kentucky organization
argues:
This bill follows the electronic tracking program ? in
Kentucky. The vendor [for] ? California under AB 1455
is the same vendor that provides those services in
Kentucky. We regret to inform you that the electronic
tracking method that your committee is now considering
has failed miserably in Kentucky to reduce meth labs.
Our initial hopes for its success proved groundless.
Not only has electronic tracking not succeeded in
reducing meth labs, but we now have more meth labs
than we have ever had. The failure of electronic
tracking in Kentucky has caused [KNOA] to seek
legislation ? that is modeled after the extremely
successful Oregon approach under which pseudoephedrine
products can only be sold [by] prescription.
Some [argue] ? that the increase in Kentucky meth labs
was due to the electronic tracking system helping
police find more meth labs. But out of 741 meth labs
in 2009 we have tracked only 52 of those directly
related to [electronic tracking]. The industry
[argues] that the system is free. It cost Kentucky
law enforcement over $1.5 million to clean up labs in
2009.
WOULD THE ELECTRONIC TRACKING APPROACH PROPOSED BY THIS BILL
REDUCE THE INCIDENCE OF METH LABS?
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