BILL ANALYSIS                                                                                                                                                                                                    



                                                                  AB 599
                                                                  Page  1

          Date of Hearing:   April 21, 2009

                            ASSEMBLY COMMITTEE ON HEALTH
                                  Dave Jones, Chair
                  AB 599 (Hall) - As Introduced:  February 25, 2009
           
          SUBJECT  :   Forensic blood alcohol testing laboratories.

           SUMMARY  :   Exempts a laboratory that is accredited in forensic  
          alcohol analysis by the American Society of Crime Laboratory  
          Directors/Laboratory Accreditation Board (ASCLD/LAB) or by  
          another accrediting body approved by the Forensic Alcohol Review  
          Committee (review committee) from oversight by the Department of  
          Public Health (DPH).   
           
          EXISTING LAW  : 

          1)Requires laboratories engaged in forensic alcohol analysis by  
            or for law enforcement agencies for the purposes of  
            determining alcohol concentration in persons involved in  
            traffic accidents or violations (forensic alcohol  
            laboratories) to comply with DPH regulations in existence on  
            December 31, 2004, until those regulations are revised, as  
            specified.

          2)Prohibits DPH from requiring licensing of forensic alcohol  
            laboratories, notwithstanding licensing requirements in  
            regulations in 1) above.

          3)Requires forensic alcohol laboratories to follow the ASCLD/LAB  
            guidelines for annual external proficiency testing, as  
            specified.  (Proficiency testing in forensic alcohol analysis  
            is a quality assurance activity in which a laboratory or  
            analyst analyzes samples to determine whether they correctly  
            identify the alcohol concentration of the samples.)

          4)Requires DPH to establish the review committee with specified  
            membership to review DPH regulations concerning forensic  
            alcohol laboratories, suggest revisions, and provide these  
            suggested revisions to the California Health and Human  
            Services Agency (CHHSA) for approval.  Requires DPH to adopt  
            CHHSA-approved recommendations of the review committee.  

           Existing Regulations  :









                                                                  AB 599
                                                                  Page  2

          1)Require each forensic alcohol laboratory to have a valid  
            license issued in accordance with regulations, and establish  
            qualifications for licensing, including staffing and personnel  
            functions and qualifications, maintenance of a quality control  
            program, satisfactory performance in proficiency tests  
            conducted by DPH, and passing on-site inspections.  However,  
            SB 1623 (Johnson), Chapter 337, Statutes of 2004, eliminates  
            the licensing authority of DPH while leaving regulations in  
            place until revised, as specified. 

          2)Require organizations conducting training for forensic alcohol  
            analysts to obtain approval from DPH, and authorize DPH to  
            contract with qualified persons to administer examinations of  
            applicants for analysts. 

          3)Specify the procedures and conditions for collecting blood,  
            urine, and breath samples for analysis.

          4)Require each forensic alcohol laboratory to file with DPH a  
            detailed and current written description of methods used for  
            forensic alcohol analysis, including calibration procedures  
            and a quality control program for each method, and for these  
            descriptions to be readily available to those performing  
            analyses and to DPH. 

          5)Establish forensic alcohol laboratory performance standards,  
            including accuracy and precision within 5% of the known value  
            of a sample and adequate specificity for traffic law  
            enforcement, among others, as evaluated by DPH through  
            proficiency tests. 

          6)Specify procedural standards, and require a specified quality  
            control program, for methods of forensic alcohol analysis.  

          7)For breath alcohol analysis, authorize the use of breath  
            analysis instruments outside of forensic alcohol laboratories  
            by non-forensic alcohol laboratory analysts only if such  
            places and persons are under the jurisdiction of a  
            governmental agency or licensed forensic alcohol laboratory,  
            as specified. 

          8)Require forensic alcohol analysis instruments to meet  
            specified federal standards.  For each person tested, require  
            two samples which result in blood alcohol determinations that  
            differ by no more than 0.02%.  Specify test procedures, error  








                                                                  AB 599
                                                                  Page  3

            tolerances, and frequency for performance testing of breath  
            alcohol testing equipment. 

          9)Require forensic alcohol laboratories to maintain records of  
            personnel, analysis samples and results, quality control  
            program, proficiency tests, equipment performance tests, and  
            training. 

           FISCAL EFFECT  :   This bill has not been analyzed by a fiscal  
          committee.

           COMMENTS  :   

           1)PURPOSE OF THIS BILL  .  According to the author, DPH oversight  
            of a laboratory that is accredited by ASCLD/LAB results in a  
            duplicative process, wasting thousand of dollars a year, and  
            does nothing to ensure that the highest quality of forensic  
            blood alcohol testing is achieved in the State of California.   
            The author states this bill is needed because the removal of  
            DPH oversight of ASCLD/LAB accredited laboratories would  
            eliminate the duplicative process that is currently in place,  
            resulting in savings of taxpayer resources and allowing for  
            more regular inspection by DPH of non-accredited laboratories.  
             The author contends the accreditation of crime laboratories  
            through ASCLD/LAB would ensure a higher standard for crime  
            laboratories that has not been achieved under the oversight of  
            DPH.

           2)FORENSIC ALCOHOL LABORATORIES  .  According to DPH, in  
            California, 38 forensic alcohol laboratories conduct alcohol  
            analysis and other forensic tests.  City, county, and state  
            governmental law enforcement agencies operate 28 of these  
            forensic alcohol laboratories, and ten are private  
            laboratories.  Some of these private laboratories provide  
            testing services for law enforcement through contractual  
            arrangements with cities and counties.  Twenty-six of the  
            forensic alcohol laboratories (all governmental) are  
            accredited by ASCLD/LAB.  The 38 forensic alcohol laboratories  
            annually conduct approximately 200,000 alcohol tests,  
            including breath alcohol tests conducted by law enforcement  
            officials. 

           3)dui  .  According to the Department of Motor Vehicles (DMV),  
            there were nearly 204,000 driving under the influence of  
            alcohol (DUI) arrests in California in 2007, for a rate of 863  








                                                                  AB 599
                                                                  Page  4

            per 100,000 licensed drivers.  Approximately 3% of DUI arrests  
            were felony arrests and 97% were misdemeanor arrests.  Of all  
            DUI arrests, three-quarters led to convictions for DUI, and  
            7.4% led to convictions for alcohol-related reckless driving.   
            DMV reports that the 1,489 alcohol-involved fatalities  
            represented 37.5% of the state's motor vehicle-related deaths.  
             DMV also reports there were 30,783 traffic injuries that  
            involved alcohol use. 

           4)DPH FORENSIC ALCOHOL PROGRAM  .  According to the DPH Web site,  
            the conviction and removal of drunk drivers from California's  
            streets and highways provides important public health and  
            safety benefits.  DPH notes that in 2005, alcohol-related  
            collisions killed 1,719 California residents, and thousands  
            more were injured.  DPH states enforcement of the state's DUI  
            laws by testing for concentration of alcohol in persons  
            involved in traffic violations is a critical component of the  
            state's efforts to control drunk driving.  The goals of the  
            Forensic Alcohol Program (FAP) are to ensure the competency of  
            forensic alcohol laboratories, the qualifications of the  
            employees of the laboratories, and the accuracy of breath  
            alcohol testing procedures used by law enforcement agencies.   
            DPH states that unlike other forensic testing, which typically  
            yields qualitative results, forensic alcohol testing is  
            quantitative, and accuracy is critically important when the  
            difference between a blood alcohol concentration of 0.07% and  
            0.08% determines whether a law has been violated. 

          DPH states that SB 1623 removed its statutory authority to  
            license forensic alcohol laboratories.  DPH also ceased  
            routine onsite inspections at that time, but maintains  
            authority to conduct inspections for cause, and is still  
            required to regulate forensic alcohol laboratories.  The DPH  
            forensic alcohol analysis regulatory program staff includes  
            three chemists and one administrative support position.  

           Proficiency Tests  .  DPH annually requires two proficiency  
            testing events of each forensic alcohol laboratory, and  
            laboratories are required to participate in an additional  
            ASCLD/LAB-approved proficiency test and provide these results  
            to DPH.  Each proficiency testing event includes four samples  
            at two levels of alcohol concentration.  Laboratories that use  
            more than one method for forensic alcohol analysis must submit  
            test reports for each method used.  A laboratory must reach a  
            finding within 5% of the correct answer in order to pass.  If  








                                                                  AB 599
                                                                  Page  5

            a laboratory does not pass, DPH works with the laboratory to  
            correct the problem.  

           Laboratory Personnel  .  DPH regulations allow only DPH-approved  
            forensic alcohol supervisors, analysts, and trainees to  
            perform forensic alcohol analysis.  DPH approves individuals  
            nominated by their laboratories based on education and  
            experience, demonstrated accuracy in the analysis of  
            proficiency test samples provided by DPH, and successful  
            completion of an examination prescribed by DPH.  DPH states  
            that it generally reviews nominees' qualifications within one  
            week, and provides examinations for nominees three to four  
            times per year.  DPH states it has not recently received  
            complaints about the frequency of examinations. 

           Forensic Alcohol Methods  .  DPH no longer requires each forensic  
            alcohol laboratory to annually submit its lab procedures for  
            review.  However, laboratories are still required to maintain  
            detailed and current written descriptions of each method and  
            to make them available to DPH on request. 

           Training Programs  .  Laboratories providing training for persons  
            to meet requirements for forensic alcohol testing, for  
            example, for law enforcement officers operating breath alcohol  
            instruments, must submit descriptions of the training to DPH  
            for review and approval. 

           5)Review committee  .  Pursuant to SB 1623, in 2005, DPH  
            established the review committee to review DPH regulation of  
            forensic alcohol laboratories and recommend revisions to limit  
            the regulations to those that are reasonably necessary to  
            ensure the competence of the laboratories.  The review  
            committee membership is required to include eight members  
            representing prosecuting attorneys; defense attorneys; law  
            enforcement; coroners, medical examiners, or pathologists;  
            criminalists; toxicologists; crime laboratory directors; and,  
            DPH.  According to DPH, the review committee has met eight  
            times but has not yet completed its determinations.  Last  
            year, the review committee created a subcommittee to develop  
            draft regulations.  The subcommittee has met three times and  
            has drafted revisions to existing regulations.  The review  
            committee met on April 10, 2009 to review the draft  
            regulations developed by the subcommittee.   
           
           6)ASCLD/LAB ACCREDITATION  .  According to the 2006 ASCLD/LAB  








                                                                  AB 599
                                                                  Page  6

            Accreditation Program Overview, the ASCLD/LAB-International  
            laboratory accreditation program uses International Standards  
            Organization (ISO) standard "ISO/IEC 17025 General  
            requirements for the competence of testing and calibration  
            laboratories," published in 2005.  ISO/IEC 17025 is not  
            specific to forensic alcohol analysis labs, but instead  
            applies to testing and calibration laboratories generally.   
            ASCLD/LAB-International published supplemental requirements  
            for the accreditation of forensic science laboratories, which  
            include the following disciplines: controlled substances;  
            trace evidence; biology; questioned documents; digital  
            evidence; toxicology; firearms and toolmarks; latent prints;  
            and, crime scene.  Additionally, ASCLD/LAB-International  
            published supplemental requirements for the accreditation of  
            breath alcohol calibration laboratories.  

          The ASCLD/LAB-International accreditation criteria address  
            numerous aspects of laboratory operations, and generally  
            require a lab to have a procedure to address a specific issue  
            but in many areas are not prescriptive as to the specific  
            methods for accomplishing a given objective.  For example, the  
            criteria for personnel include a requirement that the  
            management of the laboratory formulate the goals with respect  
            to education, training, and skills of the laboratory  
            personnel.  The supplemental requirements for the  
            accreditation of breath alcohol calibration laboratories also  
            generally are not prescriptive as to how a lab must accomplish  
            an objective.  For example, the laboratory must have a  
            director whose responsibilities and authorities must be  
            defined, or documentation to support calibrations must be such  
            that another competent analyst could evaluate what was done  
            and interpret the data.  However, the ASCLD/LAB criteria do  
            specify that an analyst who works in breath alcohol  
            calibration must have a baccalaureate or advanced degree in a  
            natural science, toxicology, criminalistics, or a closely  
            related field. 

          ASLCD/LAB grants accreditation for five years, provided a  
            laboratory continues to meet standards, including completion  
            of an annual report and participation in prescribed  
            proficiency testing programs.  A new application and on-site  
            inspection are required every fifth year.
           7)BUREAU OF state auditS report  .  In 1999, the California Bureau  
            of State Audits (BSA) published a report that concluded the  
            DPH (then Department of Health Services (DHS)) FAP needed to  








                                                                  AB 599
                                                                  Page  7

            reevaluate its regulation of forensic alcohol laboratories.   
            BSA stated DPH's efforts emphasized reviewing written methods,  
            did not focus on issues that would improve laboratories'  
            analyses, and were not completed promptly.  BSA recommended  
            the FAP should spend more time on site visits and increase  
            proficiency testing, noting that proficiency testing evaluates  
            the abilities of the analysts but also indirectly assesses the  
            laboratory's written methods.  The BSA report also noted that  
            FAP review might duplicate a great deal of the ASCLD/LAB's  
            evaluation and might not be fully necessary.  FAP responded by  
            stating that it was implementing recommendations to ensure  
            timely reviews, and would be able to double its staffing and  
            therefore be able to improve timeliness and increase  
            inspections.  FAP also responded that ASCLD/LAB does not  
            actually have performance standards or procedure requirements  
            specific to forensic alcohol analysis, among other concerns.  

           8)PREVIOUS LEGISLATION  .  

             a)   SB 1623 eliminates the licensing authority of DHS (now  
               DPH) over forensic alcohol laboratories, and requires  
               laboratories to ensure that blood alcohol testing  
               instruments and calibrating devices meet specifications,  
               and follow ASCLD/LAB guidelines. 

             b)   SB 1849 (Johnson) of 2000 would have required DHS (now  
               DPH) to revise regulations of laboratories engaged in  
               breath alcohol testing in accordance with specified  
               reference materials and to submit the proposed regulations  
               to a review committee.  SB 1849 would have also required  
               DPH to license a laboratory accredited by ASCLD/LAB to  
               perform forensic alcohol tests, if the director of DPH  
               determined that ASCLD/LAB's published standards met those  
               of DPH regulations, and would have exempted an accredited  
               laboratory from departmental regulations, except  
               proficiency testing requirements.  Governor Davis vetoed SB  
               1849, stating:

                    While the August, 1999 report by the Bureau of  
                    State Audits regarding the DHS forensic alcohol  
                    regulatory program raised some serious concerns,  
                    I am confident that the DHS can address the  
                    issues that have been raised and am directing DHS  
                    to make these concerns a high priority.









                                                                  AB 599
                                                                  Page  8

                    In addition, this bill goes beyond the  
                    recommendations of the Bureau of State Audits.   
                    If I am not convinced that sufficient progress  
                    has been made by DHS within the next year, I will  
                    consider signing a modified version of this bill.

           9)SUPPORT  .  Numerous proponents, including the Ventura County  
            Sheriff's Department, the District Attorney of Santa Clara  
            County, the San Diego County Sheriff's Department, the  
            Sheriff-Coroner Department of San Bernardino County, the  
            Sheriff-Coroner Department, County of Orange, the Los Angeles  
            County Sheriff's Department, and the City and County of San  
            Francisco Police Department, write in support of this bill  
            that DPH regulation of forensic alcohol laboratories is  
            duplicative and unnecessary to ensure the highest quality, and  
            this bill will allow DPH to direct limited resources to  
            regulating non-accredited laboratories.  Proponents further  
            argue that ASCLD/LAB standards are much higher than those of  
            DPH, and pertain not only to alcohol but other forensic  
            laboratory functions as well.
           10)OPPOSITION  .  The California Attorneys for Criminal Justice  
            (CACJ) and the California DUI Lawyers Association (CDLA) write  
            in opposition to this bill that it precludes public  
            participation and oversight of critical regulations,  
            negatively impacts DMV hearings related to driver's license  
            suspensions, and disrupts standardized approaches to DUI  
            cases.  CACJ and CDLA write that DMV is authorized to take an  
            administrative action to suspend the driver's license of  
            anyone arrested for DUI; this administrative action enjoys  
            shortcuts based on the Evidence Code which allow DMV to base  
            its case on documentary evidence rather than requiring live  
            testimony from witnesses.  CDLA states one of the shortcuts  
            relies on the regulations governing forensic alcohol  
            laboratories based on a presumption that a government agent  
            performs its duties properly.  The regulations provide the  
            basis for the presumption that the results obtained by the  
            forensic alcohol laboratory are reliable.  CACJ and CDLA write  
            that the blood alcohol reports are proper only if the  
            individual who conducted the analyses and prepared the reports  
            comply with the regulations.  CDLA writes that without the  
            regulations, there will be no official duty to follow any  
            specific standard and DMV will be forced to call witnesses to  
            establish that the ASCLD/LAB accreditation criteria form an  
            adequate basis for reliable results.  CDLA further argues that  
            under this bill, laboratories could choose whatever means they  








                                                                  AB 599
                                                                  Page  9

            desired to meet the accreditation criteria because the  
            criteria allow the individual laboratories to justify their  
            procedures.  CDLA states the ASCLD/LAB standards are not  
            specific and that accreditation is a five-year cycle.  CDLA  
            states accreditation is a good thing but should not take the  
            place of regulation, and exception from regulation will open a  
            floodgate of litigation.  CDLA suggests as an alternative to  
            this bill that the work of the review committee be adopted in  
            statute, thereby preserving the intent of SB 1623. 

           11)POLICY QUESTIONS  . 

             a)   Given the importance of ensuring the safety of our  
               roads, the magnitude of the DUI problem, and the potential  
               consequences of a DUI conviction, is it prudent to  
               relinquish regulation of forensic alcohol laboratories?  

             b)   The review committee has had a subcommittee working on  
               draft regulations.  Should the Legislature consider  
               enacting in statute the revised regulations if they are  
               approved by the review committee? 

           REGISTERED SUPPORT / OPPOSITION  :   

           Support 

           California Association of Crime Lab Directors (sponsor)
          American Federation of State, County, and Municipal Employees,  
          AFL-CIO
          California Peace Officers' Association 
          California Police Chiefs Association 
          City and County of San Francisco Police Department
          District Attorney, County of Santa Clara
          Los Angeles County Sheriff's Department
          San Diego County Sheriff's Department
          Sheriff-Coroner Department, County of Orange
          Sheriff-Coroner Department, San Bernardino County
          Ventura County Sheriff's Department
           Opposition 
           
          California Attorneys for Criminal Justice
          California DUI Lawyers Association
           
          Analysis Prepared by  :    Allegra Kim / HEALTH / (916) 319-2097