BILL ANALYSIS                                                                                                                                                                                                    �



                                                               AB 1615
                                                                       

                      SENATE COMMITTEE ON ENVIRONMENTAL QUALITY
                        Senator S. Joseph Simitian, Chairman
                              2011-2012 Regular Session
                                           
           BILL NO:    AB 1615
           AUTHOR:     Miller
           AMENDED:    March 29, 2012
           FISCAL:     Yes               HEARING DATE:   June 18, 2012
           URGENCY:    No                CONSULTANT:      Rebecca 
           Newhouse
            
           SUBJECT  :    ALKALINE HYDROLYSIS

            SUMMARY  :    
           
            Existing law  :

           1) Under the Cemetery Act (Business and Professions Code �9780 
              et seq.), specifies requirements for the licensure and 
              administration of crematories by the Cemetery and Funeral 
              Bureau (bureau).  

           2) Defines terms related to cremated remains and specifies 
              requirements for crematories, including their operation, 
              the identification of remains, record keeping, and 
              requirements for accepting human remains, instruction and 
              personnel training, among other provisions. (Health and 
              Safety Code �8341 et seq.)

           3) Specifies requirements regarding the transportation, 
              disposition, appropriate conduct with, disclosure 
              statements and storage of cremated and human remains, among 
              other provisions. (Health and Safety Code �7000 et seq.)

           4) Under the Porter-Cologne Water Quality Control Program 
              (Water Code �13000 et seq.), the State Water Resources 
              Control Board (SWRCB) has authority over water quality 
              policy and also establishes nine Regional Water Quality 
              Control Boards (regional boards) to oversee water quality 
              at the local/regional level.

           5) Specifies requirements regarding water permits, small water 
              systems, water recycling criteria, domestic water quality 









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              and monitoring, maximum contaminant levels, compliance 
              requirements, surface water treatments and hazardous waste 
              management and standards, among other requirements. 
              (California Code of Regulations, Title 22)

           6) Requires the Department of Toxic Substances Control to 
              issue hazardous waste permits and impose conditions on 
              those permits specifying requirements for the storage, 
              treatment, or disposal of hazardous waste. (Health and 
              Safety Code �25200)

           7) Under the auspices of the US EPA, pursuant to the federal 
              Clean Water Act, the SWRCB and the nine regional boards are 
              responsible for the review and approval of Publicly Owned 
              Treatment Works pretreatment (the process of removing 
              pollutants from industrial wastewaters before they are 
              discharged into municipal sewage treatment systems) 
              programs, and for granting National Pollution Discharge 
              Elimination System (NPDES) permits, which outline the 
              pretreatment program monitoring and reporting requirements 
              for POTWs and other dischargers of pollutants into 
              navigable waters. 

           8) Under the Sanitary District Act of 1923 (Health and Safety 
              Code �6400), authorizes the formation of sanitation 
              districts which may make and enforce all necessary and 
              proper regulations for sanitary purposes not in conflict 
              with any state laws.  The Act specifies that a violation of 
              a regulation or ordinance of a district is a misdemeanor 
              punishable by imprisonment in the county jail not to exceed 
              30 days, or by a fine not to exceed one thousand dollars, 
              or by both.

            This bill  :  

           1) Specifies requirements for the licensure and administration 
              of hydrolysis facilities by the bureau.  

           2) Defines terms related to hydrolyzed remains and specifies 
              requirements for hydrolysis facilities, including their 
              operation, identification of remains, record keeping, and 
              requirements for accepting human remains, instruction and 
              personnel training, among other provisions.  Among other 









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              terms, the bill defines the following terms related to 
              hydrolyzed remains, including: 

              a)    "Hydrolysis," a process involving three steps, 
                 namely:

                 i)         The reduction of the body of a deceased 
                      person to its essential chemical components by a 
                      chemical process using heat, high pressure, water 
                      and potassium hydroxide to dissolve human tissue 
                      within a hydrolysis container.

                 ii)        The use of the least amount of potassium 
                      hydroxide possible that is still effective for 
                      complete dissolution.

                 iii)       Processing the remains after the removal from 
                      the hydrolysis chamber. 

              b)    "Hydrolyzed remains," meaning the bone fragments of a 
                 human body that are left after hydrolysis in a 
                 hydrolysis facility.

              c)    "Hydrolysis facility," meaning a building or 
                 structure containing one or more vessels for the 
                 reduction of bodies of deceased persons by alkaline 
                 hydrolysis.

              d)    "Hydrolysis vessel," meaning the enclosed space 
                 within which the hydrolysis of human remains is 
                 performed.


           3) Specifies requirements regarding the transportation, 
              disposition, appropriate conduct with, disclosure 
              statements and storage of hydrolyzed remains, among other 
              provisions. 

           4) Requires the bureau to require an applicant to prove 
              compliance with all applicable laws, rules, regulations, 
              ordinances, and orders, and prohibits the bureau from 
              issuing a hydrolysis facility license until the bureau is 
              satisfied that the public interest, human health, and 









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              environmental quality will be served by the applicant. 

           5) Requires an applicant to obtain all relevant permits from 
              local and state agencies to demonstrate compliance with 
              hazardous waste, water quality, and drinking water 
              standards, including, but not limited to, Health and Safety 
              Code �25200 et seq., Title 22 of the California Code of 
              Regulations and the Porter-Cologne Water Quality Act (Water 
              Code �1300 et seq.).

           6) Requires that a hydrolysis facility applicant be inspected 
              annually by the Certified Unified Program Agencies.

           7) Requires that allowable hydrolysis vessels for the 
              disposition of human remains shall meet or exceed State 
              Department of Public Health and federal Centers for Disease 
              Control and Prevention requirements for complete 
              destruction of human pathogens.


            COMMENTS  :

            1) Purpose of Bill  .  According to the author, AB 1615 creates 
              a permitting, licensing and regulatory statute in the 
              Business and Professions and Health and Safety codes for 
              alkaline hydrolysis that parallels existing permitting, 
              licensing and regulatory statutes for traditional cremation 
              and paves the way for new business opportunity and job 
              creation in the state by introducing regulations for the 
              commercial operation of new, safe and environmentally 
              responsible, end of life alternatives for the people of 
              California.  The author notes that unlike cremation by 
              incineration, alkaline hydrolysis does not pollute the air, 
              and emits 20 times less CO2.  The author further states 
              that alkaline hydrolysis neutralizes embalming fluids and 
              toxins to protect soil and underground water from 
              pollutants.

            2) Background  .  Alkaline hydrolysis (also known by trademark 
              names, including BIO Cremation and Resomation) is a process 
              by which human or animal tissue can be dissolved into their 
              chemical components.  The process involves subjecting the 
              body to a basic, or alkaline, solution and is typically 









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              accomplished by immersing the body in a solution with a 
              high concentration of potassium hydroxide (pH 14).  
              Hydroxide is able to react with and break down (or 
              hydrolyze) the organic material, including fats, 
              carbohydrates, proteins, and nucleic acids, that make up 
              our body into their simpler components, namely amino acids 
              and peptides, sugars, fatty acids and nucleotides.  
              Although alkaline conditions will break down organic 
              material without applied heat, increasing the temperature 
              significantly increases the rate of decomposition.  Some 
              hydrolysis vessels use applied pressure to increase the 
              temperature to nearly double that of the normal boiling 
              point of water and can therefore accomplish complete 
              dissolution of tissue within two to three hours.  After the 
              effluent from the hydrolysis procedure is drained, 
              nonhydrolyzable bone fragments are recovered, rinsed and 
              subsequently pulverized into a powder that can be disposed 
              of in a manner analogous to cremated remains.  Plastics and 
              biocompatible metals used in the body as stents, 
              prosthetics and pacemakers, should not readily react with 
              sodium hydroxide and could also be recovered at the 
              completion of hydrolysis.

              The process has been used for years to dispose of animal 
              carcasses at veterinary, biotech and pharmaceutical 
              settings.  The University of Florida, Gainesville, was the 
              first to use the technology for medical school cadavers and 
              the Mayo Clinic and the UCLA medical school have since 
              adopted the technology for disposal of human bodies.  The 
              use of alkaline hydrolysis as a commercial alternative to 
              cremation or burial is currently legal in Minnesota, Maine, 
              Oregon, Colorado and Florida.  

            3) Where does the hydrolysis effluent go  ?  Bones and 
              hydrolysis effluent (from 100 to 300 gallons depending on 
              the engineering of the hydrolysis vessel) are left over at 
              the completion of the hydrolysis process.  The fluid waste 
              is described as a viscous alkaline, coffee-colored liquid.  
              One way for a facility to potentially dispose of the 
              effluent would be to discharge the liquid to the sewer 
              system to be processed in the local wastewater treatment 
              plant and ultimately discharged to surface water.  The 
              other possibility is that the effluent could be directly 









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              discharged to surface water. 

              Under AB 1615, a facility intending to discharge their 
              effluent to the regional sewer system would be subject to 
              the rules and regulations of their local sanitation 
              district.  Sanitation districts have various requirements 
              for commercial and industrial wastewater discharge 
              including pH level, concentration of organic material, 
              total dissolved material, fats, oils and grease, 
              temperature, heavy metals, dissolved chemicals, and 
              effluent viscosity.  AB 1615 requires hydrolysis facilities 
              applying for licensing to prove their compliance with the 
              local waste water discharge requirements to the bureau. 

              If a facility intended to discharge the hydrolysis effluent 
              directly to surface water, AB 1615 requires them to apply 
              for an NPDES permit from the appropriate Regional Water 
              Quality Control Board, and demonstrate NPDES permit 
              compliance to the bureau before they could be licensed, and 
              therefore authorized, to conduct hydrolyses. 
               
              In addition to meeting local requirements for sewer 
              discharge, or state and federal requirements for surface 
              water discharge, AB 1615 specifies that the hydrolysis 
              facility applying for a license from the bureau must obtain 
              all relevant permits from local and state agencies to 
              demonstrate compliance with hazardous waste, water quality 
              and drinking water standards and must also prove compliance 
              with all applicable laws, rules, regulations, ordinances 
              and orders to the bureau.  

            4) An alternative to cremation  .  During cremation, the organic 
              components are oxidized to CO2 in temperatures approaching 
              1000 C and can take two to four hours depending on the 
              size of the body.  In comparison, because the alkaline 
              water is heated to upwards of 200 degrees for two to three 
              hours (if the vessel is pressurized), alkaline hydrolysis 
              has the potential to use much less energy during the 
              procedure than cremation, ultimately translating to fewer 
              CO2 emissions, in addition to avoiding additional CO2 
              release from burning the body.  According to the EPA, coal 
              and oil-fired power plants are currently the dominant 
              emitters of mercury in the US, so less energy usage during 









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              hydrolysis as compared to cremation may indirectly lead to 
              less mercury released into the environment.  However, the 
              energy savings during the hydrolysis procedure may be 
              attenuated by the fact that alkaline hydrolysis requires 
              large amounts of sodium or potassium hydroxide, both of 
              which are commonly produced on the industrial scale through 
              electrolysis. 

              Temperatures reached during cremation are capable of 
              vaporizing mercury and releasing it into the atmosphere.  
              Pollutants, such as NOx, can also be released during 
              cremation.  Because of the lower temperature and lack of 
              reactivity between potassium hydroxide and amalgam, there 
              is less risk of mercury in fillings contaminating the 
              water.  However, there is a possibility that some 
              relatively small quantity of mercury and other heavy metals 
              accumulated in fatty tissues in individuals over a 
              lifetime, as well as unmetabolized pharmaceuticals, may be 
              released in to the hydrolysis effluent.  Concentrations of 
              these contaminants are likely to be low, and after the 
              hydrolysis process, reduced even further. 

              One area of concern regarding the use of alkaline 
              hydrolysis is that many embalming chemicals used to 
              preserve bodies for viewing are highly toxic, and some, 
              including formaldehyde and phenol, are carcinogenic.  
              Unpublished initial studies from Mayo Clinic samples show a 
              95 percent reduction in formaldehyde after an alkaline 
              hydrolysis procedure at high temperature and pressure, 
              however these results are unclear regarding the identity of 
              the end products of the reaction.

                        Amendment needed:  Because of the 
                   preliminary nature of the data, as well as the 
                   lack of data regarding the fate of toxics other 
                   than formaldehyde used in the embalming process 
                   after the hydrolysis procedure, and the 
                   potential impact of toxic embalming chemicals 
                   on small water treatment systems, amendments 
                   should prohibit bodies that have been embalmed 
                   from undergoing alkaline hydrolysis. 

            1) Is the bureau the appropriate agency to ensure compliance 









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              with environmental regulations  ?  The language in the bill 
              clearly states that an alkaline hydrolysis facility 
              applying to the bureau for licensure must obtain all 
              relevant permits to demonstrate compliance with hazardous 
              waste, water quality, and drinking water standards and that 
              in order to be licensed, the applicant must provide proof 
              of their compliance with all applicable laws, rules, 
              regulations, ordinances, and orders to the bureau.  Is the 
              bureau, without any input from departments with expertise 
              in the area of water quality regulation and toxic or 
              hazardous material regulation, the appropriate entity to 
              determine whether an alkaline hydrolysis facility applicant 
              has proven their compliance to ensure environmental 
              quality? 

                        Amendment needed:  An amendment is needed 
                   to require the bureau, in consultation with the 
                   appropriate state agency or agencies, to develop 
                   regulations specifying which permits from local 
                   and state agencies are necessary to demonstrate 
                   compliance with hazardous waste, water quality 
                   and drinking water standards, as well as any 
                   other documentation necessary for a hydrolysis 
                   facility applicant to prove compliance with all 
                   applicable environmental rules and regulations.

            1) Minimum requirements for a licensed hydrolysis vessel  .  
              Studies have shown that most pathogens, including viruses 
              and bacteria, are effectively sterilized with high pH or 
              high temperature solutions.  However, infectious proteins, 
              or prions, have been found to be much more resilient to 
              standard sterilization methods.  According to the CDC, the 
              combination of applied heat and chemical solution is the 
              most effective treatment for inactivating prions. They 
              recommend exposing surfaces or instruments to 121 C at pH 
              13 to inactivate prions. 

                        Amendments needed:  Although the bill 
                   specifies that the allowable hydrolysis vessels 
                   meet parameters specified by the California 
                   Department of Public Health and the Center for 
                   Disease Control, amendments are needed to 
                   require the bureau, in consultation with the 









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                   appropriate state agency, to adopt regulations 
                   for the specific requirements of allowable 
                   hydrolysis vessels regarding the minimum 
                   temperature and duration of the hydrolysis to 
                   ensure the destruction of pathogens, and adopt 
                   regulations specifying the requirement that 
                   acceptable hydrolysis vessels must be automated 
                   and manufactured for the specific purpose of 
                   performing hydrolysis on deceased human bodies.  
                   The bureau should also require hydrolysis 
                   vessels that use applied pressure to be 
                   certified by an appropriate organization, such 
                   as the American Society of Mechanical Engineers. 


              Currently the bill defines hydrolysis as a process that 
              uses heat, pressure and potassium hydroxide to dissolve 
              tissue.  Although the process takes significantly longer, 
              hydrolysis does not require applied pressure.  In addition, 
              other bases like sodium hydroxide could potentially be used 
              to complete the hydrolysis process. 

                        Amendments needed:  Amendments are needed 
                   to modify the definition of alkaline hydrolysis 
                   to allow, but not require, the use of applied 
                   pressure and to include sodium hydroxide, in 
                   addition to potassium hydroxide, as the 
                   allowable chemical method for the alkaline 
                   hydrolysis process. 

            1) Should there be more specificity in the bill regarding the 
              records of the hydrolysis  ?  The bill currently requires 
              certain records be kept for each hydrolysis, including the 
              referring funeral director, name of deceased, date of 
              hydrolysis, name of hydrolysis vessel operator, date the 
              body was inserted into and removed from the hydrolysis 
              vessel, as well any documentation of compliance with 
              appropriate environmental and safety laws.  Upon audit, or 
              investigation of an alkaline hydrolysis facility, records 
              of the pH of the hydrolysis effluent would assist the 
              determination of compliance with local and state 
              regulations, since effluent with a pH above 12.5 is 
              considered hazardous, and the facility would be required to 









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              dispose or treat it according to applicable hazardous waste 
              laws and local sanitation district requirements.  
              Similarly, records of the duration and temperature of the 
              hydrolysis would assist the determination of compliance of 
              the facility with regulations regarding sterilization of 
              pathogens.  

                        Amendments needed:  The bill should 
                   require that the pH of the effluent, duration of 
                   hydrolysis and corresponding temperature, and 
                   pressure in the vessel, if applicable, be added 
                   to the list of information required to be 
                   recorded. 

            1) Worker safety training requirements and safety equipment  .  
              Potassium and sodium hydroxide are highly corrosive 
              substances that can cause severe burns upon contact and 
              irreversible lung damage if inhaled. Hydrolysis employees 
              that will work with and around hydrolysis vessels and 
              alkaline solutions should be given the appropriate training 
              regarding the safe handling of basic solutions, as well as 
              acidic solutions, if applicable. Appropriate safety 
              equipment, including eye washes and emergency showers, 
              should also be available to employees in the accidental 
              exposure.

                        Amendments needed:  Procedures and 
                   precautions regarding the safe handling of high 
                   pH solutions, and if applicable, low pH 
                   chemicals, should be included in employee 
                   training and tests for those workers who will 
                   work directly with the alkaline hydrolysis 
                   vessels or large quantities of alkaline 
                   solution.  Hydrolysis facilities applying for a 
                   license should also demonstrate their compliance 
                   with all state and federal laws and regulations 
                   regarding worker safety. 

            1) Consistency  .  Under AB 1615, the definition of hydrolysis 
              specifies that whenever possible, the least amount of 
              potassium hydroxide that is still effective for complete 
              dissolution of remains.  However, the disclosure statement 
                states that "the process may not result in complete 









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              dissolution."  This inconsistency should be clarified. 

            2) Arguments in support  .  Supporters of this measure say that 
              hydrolysis is a safe and environmentally friendly way to 
              handle the deceased.  They also state that this measure 
              allows for the necessary change and advancement for the 
              "end of life" options for families. 

            3) Arguments in opposition  .  The California Catholic 
              Conference, Inc. states that AB 1615 does not effectively 
              distinguish between 'cremated remains' and 'hydrolyzed 
              remains,' and that alkaline hydrolysis was not designed to 
              dispose of dead human bodies.  They also note that while 
              they do not believe the process is 'evil,' they do find it 
              to be a particularly casual, and perhaps disrespectful, 
              disposition of human remains. Orange County Water District 
              is concerned that AB 1615 fails to provide the necessary 
              safeguards to protect the public from the risk of prions, 
              as well as the potential introduction of toxic embalming 
              fluids into the wastewater stream.  They further add that 
              the funeral industry is fundamentally unregulated and they 
              cannot trust that individual permittees would have the 
              technical skill to ensure that harmful chemicals are not 
              introduced into the wastewater stream. They also argue that 
              the energy requirements for the system are understated, and 
              that there is a large carbon footprint associated with the 
              process.  

            4) Technical amendments  . 

              a)    The definition of hydrolysis vessel should be 
                 broadened to include other hydrolysis vessel components 
                 that are not precisely within "enclosed space" but are 
                 necessary for the safe and proper functioning of the 
                 equipment. 

              b)    The word "remains" should be added after the word 
                 "hydrolysis" on page 7, line 14. 

              c)    The word "manger" should be changed to "manager" on 
                 page 3, line 14.

            5) Related legislation  .  The following are related to the 









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              licensing and regulation of the practice of alkaline 
              hydrolysis:
               
              a)    AB 2283 (Miller) of 2010 defines alkaline hydrolysis 
                 as a type of cremation and required the bureau to adopt 
                 regulations for the operation of alkaline hydrolysis 
                 chambers.  The bill was held in the Senate Environmental 
                 Quality Committee at the request of the author. 

              b)    AB 4 (Miller) of 2011 authorizes the bureau to 
                 license and regulate hydrolysis facilities and 
                 hydrolysis facility managers, as specified.  AB 4 was 
                 held on the Assembly Appropriations Committee Suspense 
                 File.

            6) Double referral to Senate Business, Professions and 
              Economic Development  Committee  .  If this measure is 
              approved by this committee, the do pass motion must include 
              the action to re-refer the bill to the Senate Business, 
              Professions and Economic Development Committee.


            SOURCE  :        Assemblymember Miller  

           SUPPORT  :       Association of California Cremationists
                          Cemetery and Mortuary Association of California
                          Cremation Association of North America
                          Matthews Cremation
                          2 Individuals  

           OPPOSITION  :    California Catholic Conference, Inc.  
                          Orange County Water District