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  






          ---------------------------
          <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  
               ----------------------
          <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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          |               |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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          $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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          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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                                                             AB 1455 (Hill)
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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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                                                             AB 1455 (Hill)
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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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          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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               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  































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          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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