BILL ANALYSIS                                                                                                                                                                                                    �



                                                                  AB 2425
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          Date of Hearing:  April 29, 2014

                            ASSEMBLY COMMITTEE ON HEALTH
                                 Richard Pan, Chair
                     AB 2425 (Quirk) - As Amended:  April 8, 2014
           
          SUBJECT  :  Laboratories: review committee.

           SUMMARY  :  Provides for a temporary exemption from complying with  
          existing regulations for law enforcement laboratories engaging  
          in forensic alcohol analysis tests if the laboratory is  
          accredited and provides the exemption only until the Department  
          of Public Health (DPH) updates their existing regulations.

           EXISTING LAW  :  

       1)Requires DPH to adopt and publish regulations for the operation  
            of law enforcement laboratories engaged in the performance of  
            blood alcohol level tests of blood, urine, tissue and breath  
            samples from persons involved in traffic accidents or traffic  
            violations. 

       2)Requires the blood alcohol level tests of breath samples to be  
            performed in accordance with regulations adopted by DPH, which  
            establish procedures to be used by law enforcement agencies in  
            administering these tests.

       3)Requires laboratories to follow the standards of accreditation  
            agencies for proficiency testing.

       4)Requires laboratories to ensure all breath alcohol instruments  
            and calibrating devices are products listed as conforming by  
            the federal Department of Transportation.

       5) Requires DPH to establish a forensic alcohol review committee,  
            with specified membership.

       6)Requires the review committee to review the existing regulations  
            and develop amendments to the existing regulations and submit  
            them to the California Health and Human Services Agency.

       7)Requires DPH to adopt regulations adopting the review committee's  
            recommendations.

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








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          committee.

           COMMENTS  :

           1)PURPOSE OF THIS BILL  .  According to the author, although the  
            review committee was created to updated DPH's archaic  
            regulations for forensic blood alcohol analysis and has met  
            regularly over the last 10 years, DPH and the Health and Human  
            Services Agency (HHSA) have yet to approve any regulatory  
            changes. The author states DPH regulations were written in  
            1971 and have not been updated in nearly 30 years and many  
            sections are outdated or inconsistent with California law,  
            current health advisories, and modern instrumentation and  
            technology.  Another issue the author highlights is that  
            complying with the regulation's requirements for college  
            degrees and coursework is difficult because degrees have  
            changed and cross-referencing them with courses from the 1980s  
            is challenging and creates unnecessary workload and backlog.   
            Regulations make no mention of modern technology that has  
            advanced data processing systems and mobile breath instruments  
            that allow laboratories to reach new levels of efficiency and  
            accuracy.  For example, the National Institute of Standards  
            and Technology (NIST) traceable dry gas standards allows for  
            scientists to check the calibration of their instruments with  
            every single subject breath test, versus every 10 days with a  
            solution as required by the current regulations 

            The author argues DPH's unwillingness to approve new  
            regulations impedes the review committee from completing the  
            work the Legislature has tasked them to do.  The author  
            concludes the antiquated regulations compromise public safety  
            and prosecution of drunk drivers. 

           2)BACKGROUND  .  Prior to 1969, laboratories performing forensic  
            alcohol analysis were largely unregulated. The forensic  
            community recognized a need for consistency and guidelines to  
            provide the most accurate forensic alcohol testing. In 1969,  
            legislation was passed authorizing the Department of Health  
            Services (DHS), a predecessor to DPH, to adopt regulations for  
            the testing of biological samples for alcohol content from  
            persons subject to the implied consent provisions of the  
            Vehicle Code.  The new law required DHS to form an Advisory  
            Committee on Alcohol Determination comprised of district  
            attorneys, public defenders, coroners, criminalists,  
            pathologists, and analytical chemists.  The committee met in  








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            1970, and DHS regulations, commonly referred to as Title 17,  
            were put in place in 1971.  All laboratories engaged in the  
            performance of forensic alcohol analysis, by or for a law  
            enforcement agency, were now licensed and subject to these  
            regulations. The regulations were last revised in 1986.  Only  
            laboratories performing alcohol analysis for law enforcement  
            were required to be licensed.  All other laboratories and all  
            other forensic disciplines were, and remain, exempt from state  
            regulation.

           3)DPH REGULATORY PROGRAM  .  Significant complaints about the  
            program date back to the mid-1980s.  These complaints grew and  
            culminated in a request for an audit by the Bureau of State  
            Audits which was carried out and the audit report was  
            published in 1999.  The audit by the Bureau of State Audits,  
            Department of Health Services: The Forensic Alcohol Program  
            Needs to Reevaluate its Regulatory Efforts, concluded that the  
             primary focus of DHS  and additional cumbersome requirements  
            were doing little to improve the work of alcohol laboratories.  
             (At the time, DHS was still the administering agency.)  The  
            audit documented significant waste that was occurring as a  
            result of the requirements of the program.  Shortfalls and  
            flaws in the regulations were also identified.  Finally, the  
            audit recommended the department rely more on the  
            accreditation requirements to avoid duplication and free  
            resources for more useful activities.

            An example cited in the Bureau of State Audits report as being  
            burdensome is the requirement that laboratory personnel be  
            present when peace officers were being trained on breath  
            alcohol equipment.  For large departments with hundreds, or  
            even thousands of officers, this seemed like it wasted  
            resources by requiring the presence of laboratory personnel  
            when there were other officers who were capable of doing the  
            training.  The audit report recommended this practice be  
            reassessed.  

            In 2004, the Legislature responded to the identified issues  
            and problems with the program and enacted SB 1623 (Johnson),  
            Chapter 337, Statutes of 2004.  The bill's purpose was to  
            reduce the unnecessary costs of complying with the DHS  
            regulatory program, streamline the regulatory requirements,  
            and develop regulations that actually reflected the state of  
            technology and practice in labs.  SB 1623 took the unusual  
            step of eliminating the requirement that DHS license the labs.  








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             In addition, it established the Forensic Alcohol Review (FAR)  
            Committee.  The FAR Committee is comprised of scientific, law  
            enforcement and legal representatives and was given the  
            authority to evaluate regulations and provide revisions that  
            will ensure the competence of laboratories and employees to  
            prepare, analyze, and report the results of biological samples  
            tested for alcohol content and comply with applicable laws. 

           4)SUPPORT  .  According to the sponsor, the Santa Clara County  
            District Attorney's Office, the failure to update the  
            regulations has put public safety at risk.  Since the last  
            update in 1986, the sponsor explains, there have been many  
            changes in the instrumentation and technology surrounding the  
            testing of specimens, the process by which it's done,  
            education requirements for laboratory employees, and  
            California statutes concerning driving under the influence.   
            The sponsor argues this bill recognizes how important it is  
            for the regulations to be incompliance with the law and  
            current laboratory standards and will allow the concepts  
            developed by the review committee to be adopted into  
            regulation.

           5)PREVIOUS LEGISLATION  .  

             a)   AB 599 (Hall) of 2009 would have exempted forensic  
               alcohol laboratories are accredited by the American Society  
               of Crime Laboratory Directors/Laboratory Accreditation  
               Board, or by another accrediting body approved by the FAR  
               Committee, from the requirement to comply with state  
               regulations pertaining to forensic alcohol laboratories.   
               AB 599 was vetoed by Governor Schwarzenegger who said it  
               was an improper delegation of state regulatory authority to  
               a private entity and directed stakeholders to work with DPH  
               on alternative solutions to improve regulation of labs.

             b)   SB 1623 (Johnson), Chapter 337, Statutes of 2004,  
               eliminated the licensing authority of DHS over forensic  
               alcohol laboratories and created the forensic alcohol  
               review committee,

             c)   SB 1849 (Johnson) of 2000 would have required DHS to  
               adopt regulations governing the operation of forensic  
               alcohol laboratories and required DHS to convene a review  
               committee to review the regulations and would have allowed  
               labs that meet accreditation standards to be licensed if  








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               DHS determines that the standards meet or exceed those in  
               regulations.  SB 1849 was vetoed by Governor Davis who said  
               he was confident DHS would make progress in responding to  
               the audit report and if it did not, he would consider  
               signing legislation in the future.

           1)POLICY COMMENT.   This Committee has seen a number of bills  
            introduced this year to address the issue of DPH not  
            developing timely and appropriate regulations in specific  
            areas.  Perhaps given the broad and significant  
            responsibilities of DHS, it is not surprising some efforts  
            will lag.  However, the Committee may want to consider if DPH  
            is revealing, albeit indirectly, that some of these programs  
            are of very low priority in the overall priorities of public  
            health generally and DPH specifically.  If the programs are of  
            such low priority, it raises the question whether it is worth  
            administering the program.  In the case of law enforcement  
            laboratories that conduct blood alcohol testing, the first  
            step in eliminating state regulation was taken by eliminating  
            the licensing requirement 10 years ago.  
           REGISTERED SUPPORT / OPPOSITION  :  

           Support 
           
          County of Santa Clara District Attorney's Office

           Opposition 

           None on file.

           
          Analysis Prepared by  :    Roger Dunstan / HEALTH / (916) 319-2097