BILL ANALYSIS                                                                                                                                                                                                    



                                                                  SB 797
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          Date of Hearing:   June 30, 2009

           ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS
                                Wesley Chesbro, Chair
                     SB 797 (Pavley) - As Amended:  June 25, 2009

           SENATE VOTE  :   21-16
           
          SUBJECT  :   Product safety: bisphenol A.

           SUMMARY  :   Prohibits the sale, manufacture or distribution of a  
          bottle or cup or a liquid, food or beverage in a can, jar or  
          plastic bottle that contains bisphenol A if the item is  
          primarily intended for children three years of age or younger.   
          Specifically,  this bill  :

          1)Enacts the Toxin-Free Infants and Toddlers Act.


          2)Prohibits the sale, manufacture or distribution of any bottle  
            or cup that contains bisphenol A, at a level above 0.1 parts  
            per billion (ppb), if the bottle or cup is designed or  
            intended to be filled with a liquid, food, or beverage  
            intended primarily for consumption by children three years of  
            age or younger.



          3)Prohibits the manufacture, sale, or distribution of a liquid,  
            food, or beverage in a can, jar, or plastic bottle containing  
            bisphenol A, or lined with a material containing bisphenol A,  
            at a level above 0.1 ppb, if the liquid, food, or beverage is  
            intended primarily for consumption children three years of age  
            or younger.



          4)Exempts from the above prohibitions food and beverage  
            containers designed or intended primarily to contain liquid,  
            food, or beverages for consumption by the general population.



          5)Requires manufacturers to use the least toxic alternative when  
            replacing bisphenol A in containers.








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          6)Prohibits manufacturers from replacing bisphenol A with  
            carcinogens or reproductive toxicants as identified by the  
            United States Environmental Protection Agency (US EPA) or as  
            listed in the Safe Drinking Water and Toxic Enforcement Act of  
            1986 (Proposition 65).


          7)Makes legislative findings and declarations.

           EXISTING LAW  :

          1)Prohibits the sale, manufacture or distribution in commerce of  
            toys, child care articles or products that can be placed in a  
            child's mouth that contain phthalates, as defined.

          2)Prohibits the manufacture, sale and distribution of toys that  
            are contaminated with any toxic substance.

          3)Under the Safe Drinking Water and Toxic Enforcement Act of  
            1986 (Proposition 65):

             a)   Requires the office of Environmental Health Hazard  
               Assessment (OEHHA) to publish a list of chemicals known to  
               cause cancer or reproductive toxicity and to annually  
               revise the list.

             b)   Prohibits the discharge or release of a chemical known  
               to the state to cause cancer or reproductive toxicity into  
               water, or onto or into land from which the chemical may  
               pass into drinking water.

             c)   Prohibits the knowing and intentional exposure of people  
               to a chemical known to the state to cause cancer or  
               reproductive toxicity without first giving clear and  
               reasonable warning.

          4)Requires the Department of Toxic Substances Control (DTSC), to  
            adopt regulations by January 1, 2011, to identify and  
            prioritize chemicals of concern, to evaluate alternatives, and  
            to specify regulatory responses to limit exposure or to reduce  
            the level of hazard posed by a chemical of concern found in  
            consumer products.








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          5)Requires DTSC to establish an online, public Toxics  
            Information Clearinghouse that includes science-based  
            information on the toxicity and hazard traits of chemicals  
            used in daily life.

          6)Under the Toxic Substances Control Act of 1976 (TSCA),  
            authorizes US EPA to track industrial chemicals produced or  
            imported into the United States.

           FISCAL EFFECT  :   Unknown.

           COMMENTS  :

           Purpose  :  According to the author's office, "SB 797 is a child  
          safety measure that seeks to protect infants and toddlers from a  
          harmful toxin that leaches into babies' milk and food.  While  
          most consumers believe that everyday products are tested for  
          dangerous chemicals and determined to be safe by government  
          authorities, the reality is many children's products contain  
          toxic chemicals, such as bisphenol A, that have been shown to  
          cause harm to children's health and the environment.  BPA has  
          been linked to a number of long-term health impacts such as  
          birth defects, reproductive harm, impaired learning,  
          hyperactivity and breast and prostate cancer.  Because  
          children's bodies are growing and developing, they are  
          especially vulnerable to the effects of BPA.  Regulation of BPA  
          in children's products is woefully inadequate and has not kept  
          pace with the explosion of government funded peer reviewed  
          studies in the last few years indicating a problem with BPA in  
          food and beverage products.  While the author fully supports the  
          Green Chemistry Initiative, the author believes BPA poses a  
          clear and present danger and it may be several years before the  
          Initiative is implemented and regulatory reform will not occur  
          fast enough to protect children against a health risk that is  
          well known and alternative products are available."

           What is bisphenol A  ?  According to the National Toxicology  
          Program (NTP) at the US Department of Health and Human Services,  
          bisphenol A, also known as BPA, is a chemical produced in large  
          quantities for use primarily in the production of polycarbonate  
          plastics and epoxy resins.  Polycarbonate plastics have many  
          applications including use in certain food and drink packaging,  
          water and infant bottles, compact discs, impact-resistant safety  
          equipment, and medical devices.  Polycarbonate plastics are  








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          typically clear and hard and marked with the recycle symbol "7"  
          or may contain the letters "PC" near the recycle symbol.  Epoxy  
          resins are used as lacquers to coat metal products such as food  
          cans, bottle tops, and water supply pipes.  Some polymers used  
          in dental sealants or composites contain bisphenol A-derived  
          materials.  In 2004, the estimated production of bisphenol A in  
          the United States was approximately 2.3 billion pounds, most of  
          which was used in polycarbonate plastics and resins.

           Pathways of exposure:   The NTP maintains that the primary source  
          of exposure to bisphenol A for most people is through diet.   
          While air, dust, and water are other possible sources of  
          exposure, bisphenol A in food and beverages accounts for the  
          majority of daily human exposure.  Bisphenol A can migrate into  
          food from food and beverage containers with internal epoxy resin  
          coatings and from consumer products made of polycarbonate  
          plastic such as baby bottles, tableware, food containers, and  
          water bottles.  Bisphenol A can also be found in breast milk and  
          dental sealants or composites.  Workers may be exposed during  
          the manufacture of bisphenol A and bisphenol A-containing  
          products.

          Biomonitoring studies show that human exposure to bisphenol A is  
          widespread.  In 2004, the Centers for Disease Control and  
          Prevention (CDC) found detectable levels of bisphenol A in 93%  
          of 2517 urine samples from people 6 years and older (the study  
          did not include children younger than six).  The NTP study shows  
          that the highest estimated daily intakes of bisphenol A in the  
          general population occur in infants and children.
           
          Health concerns related to bisphenol A  :  The scientific  
          literature on bisphenol A is complex, rapidly expanding and  
          seemingly pointing toward negative human health effects due to  
          bisphenol A exposure.  The NTP-CERHR Monograph on the Potential  
          Human Reproductive and Developmental Effects of Bisphenol A is  
          the most thorough scientific literature review completed by a  
          governmental agency to date.  Released in September 2008, the  
          monograph was prepared following a formal review and evaluation  
          process that included public comment and peer review.  Regarding  
          bisphenol A exposure, the NTP found:

                 Some concern for effects on the brain, behavior, and  
               prostate gland in fetuses, infants, and children at current  
               human exposures to bisphenol A.









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                 Minimal concern for effects on the mammary gland and an  
               earlier age for puberty for females in fetuses, infants,  
               and children at current human exposures to bisphenol A.

                 Negligible concern that exposure of pregnant women to  
               bisphenol A will result in fetal or neonatal mortality,  
               birth defects, or reduced birth weight and growth in their  
               offspring.

                 Negligible concern that exposure to bisphenol A will  
               cause reproductive effects in non-occupationally exposed  
               adults.

                 Minimal concern for workers exposed to higher levels in  
               occupational settings.

          (Note that the possible levels of concern, from lowest to  
          highest, are negligible concern, minimal concern, some concern,  
          concern, and serious concern.)

          Since a similar bill was heard in the Assembly last year, dozens  
          of additional studies chronicling potential adverse effects of  
          bisphenol A exposure have been published in scientific journals,  
          including studies with findings beyond potential reproductive  
          and developmental toxicity.  For example, a study published in  
          the September 17, 2008 issue of the Journal of the American  
          Medical Association found that higher levels of urinary  
          bisphenol A in humans is associated with cardiovascular disease,  
          diabetes and liver-enzyme abnormalities.

           California's Green Chemistry Initiative  :  In 2007, DTSC  
          commenced developing the California Green Chemistry Initiative,  
          and in December, 2008, it released six policy recommendations  
          for establishing a comprehensive Green Chemistry program in  
          California.  Last year, the Governor signed AB 1879 and SB 509  
          into law, which enacted two of the six recommendations.  AB 1879  
          (Feuer and Huffman) Chapter 559, Statutes of 2008, requires DTSC  
          to adopt regulations by January 1, 2011 to identify and  
          prioritize chemicals of concern, to evaluate alternatives, and  
          to specify regulatory responses where chemicals of concern are  
          found in consumer products.  SB 509 (Simitian) Chapter 560,  
          Statutes of 2008, requires DTSC to establish an online, public  
          Toxics Information Clearinghouse that includes science-based  
          information on the toxicity and hazard traits of chemicals used  
          in daily life.








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          The Green Chemistry program should yield a comprehensive process  
          to identify and manage chemicals of concern and their  
          alternatives.  However, the program is in the developmental  
          stage and there are not yet chemicals being considered at this  
          time.  AB 1879 and SB 509 did not specifically preclude the  
          Legislature from acting on chemicals that pose threats to public  
          health and the environment.

           

          Bisphenol A and Proposition 65  :  OEHHA is the lead agency for  
          the implementation of Proposition 65.  The Developmental and  
          Reproductive Toxicant Identification Committee (DARTIC) of  
          OEHHA's Science Advisory Board advises and assists OEHHA in  
          compiling the list of chemicals known to the state to cause  
          reproductive toxicity.  DARTIC, which is compiled of qualified  
          scientific experts, will consider the listing of bisphenol A at  
          its next meeting on Wednesday, July 15, 2009.



           Trends in bisphenol A management:   As anxiety about the health  
          effects of bisphenol A exposure rises and more studies on the  
          chemical are published, the trend is to restrict bisphenol A in  
          products intended for use by children, especially.  Last year,  
          Canada became the first country in the world to ban the import  
          and sale polycarbonate baby bottles containing bisphenol A.  The  
          government also pledged to spend $1.7 million over three years  
          to study the chemical.  This year, Minnesota and Connecticut  
          passed similar bans, as did the city of Chicago and counties in  
          California and New York.  A ban is under consideration in New  
          York.  A nationwide ban has also been proposed by Congress.


          In March, six baby bottle manufacturers confirmed their  
          intention to stop using bisphenol A in their bottles sold in the  
          US but will continue to sell the bottles in the UK.  Major  
          retailers and manufacturers, such as Wal-Mart and Toys R Us,  
          have publically promised to phase out the use of bisphenol A in  
          children's products.

           Setting standards in statute:   The sponsors of the bill indicate  
          that bisphenol A has been shown to adversely affect human health  








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          with exposure in the parts per trillion range, down to 25 parts  
          per trillion and lower.  To be adequately protective of public  
          health, sponsors indicate that independent scientists point to a  
          detectable level of 0.01 ppb bisphenol A.  However, the sponsors  
          note that 0.1 ppb, the standard in the bill, is the lowest level  
          of bisphenol A that is reliably detectable at this time.  Is it  
          appropriate to set standards in statute, where they cannot be  
          readily adjusted after consideration of new scientific evidence  
          or advances in technology, or is it more effective to set  
          standards through the regulatory process, which is more dynamic?

           State authority and oversight:   Just like California's current  
          prohibition on the use of phthalates in children's products,  
          this bill does not extend express enforcement authority to any  
          state agency.  Enforcement of the provisions of this bill would  
          most likely occur under Unfair Competition Law.  Additionally,  
          since Health and Safety Code 25257.1 (c) prohibits DTSC from  
          duplicating or adopting conflicting regulations for product  
          categories already regulated or subject to pending regulation,  
          it is unclear if, in the future, DTSC could take any action on  
          the products covered by this bill, even under the Green  
          Chemistry program.  Should a state agency, such as DTSC, be  
          expressly authorized to enforce the provisions of this bill?

           Regrettable alternatives  :  When a specific substance is banned,  
          the alternative may result in even more severe public health and  
          environmental consequences than were brought about by the  
          original substance.  To avoid this problem, alternatives to  
          bisphenol A should be analyzed to limit exposure and to reduce  
          the level of hazard they may pose.  Additionally, hazard traits  
          beyond carcinogenicity and reproductive toxicity (such as  
          endocrine disruption, neurological damage, etc.) should be  
          considered when determining allowable alternatives.  Such a  
          process is delineated in the Green Chemistry Initiative.

           Arguments in support  :  According to the Consumers Union,  
          "Consumers Union was one of the first organizations to test and  
          report on bisphenol A in consumer products, warning consumers  
          about the potential risks almost a decade ago.  Since Consumers  
          Union's first study, more than a hundred studies have been  
          published showing a wide range of adverse effects in animals at  
          low doses of bisphenol A, doses that approximate current levels  
          circulating in the human population.  In just this past year,  
          studies have linked BPA exposure to human health problems like  
          infertility, diabetes, and cardiovascular risk."  Environmental  








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          Working Group contends, "When the federal government will not  
          act or drags its feet, it can become necessary for a state to  
          lead the way when it comes to protecting children from the most  
          toxic chemicals in consumer products?  California cannot afford  
          to wait to see how the recently enacted Green Chemistry process  
          will work for a chemical like BPA because it is clear that we  
          might wait years for that process to be worked out.  We know  
          right now that BPA is harmful and action is needed now."  Breast  
          Cancer Fund writes, "BPA is known to disrupt the endocrine  
          system...  There are over 200 studies that document the adverse  
          impacts of this dangerous chemical on human development? Safe  
          alternatives for BPA are already on the market."
           
          Arguments in opposition:   The Civil Justice Coalition of  
          California opposes the bill because they contend that the  
          science behind the proposed ban is weak; banning bisphenol A  
          will lead to more lawsuits; scientists, not legislators, should  
          decide chemical safety; and this bill already died (in the form  
          of SB 1713, 2009).  A coalition of other opponents, including  
          the American Chemistry Council and the California Chamber of  
          Commerce, contend that, "The scientific evidence supporting the  
          safety of BPA has been comprehensively examined by many  
          government and scientific bodies worldwide in recent years?   
          These bodies have all reached conclusions that consistently  
          support the continued safe use of bisphenol A in its current  
          applications?  Assessing chemical and product safety is a  
          complex undertaking, requiring extensive scientific expertise  
          and rigorous analysis.  It is for this reason that the  
          California Legislature last year adopted in a bi-partisan manner  
          arguably the world's most comprehensive chemical management  
          regulatory program for consumer products?  The Green Chemistry  
          program is the most appropriate venue for assessing consumer  
          product and chemical safety.  SB 797 would circumvent the  
          science-based Green Chemistry program?"

           Proposed committee amendments  :  The committee may wish to  
          consider the following amendments, which, due to time  
          constraints, the author will need to take in the Assembly Health  
          Committee.

          1)Integrate the proposed bisphenol A ban, as specified by this  
            bill, with the Green Chemistry process as specified in Health  
            and Safety Code Sections 25252 and 25253, as established by AB  
            1879 (2008).









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          2)Add:  Notwithstanding 25257.1 (b) and (c), nothing in this  
            section shall prohibit or restrict the authority of the  
            department to take actions on a chemical or chemical  
            ingredient pursuant to Sections 25252 and 25253.

           Prior legislation  :  In 2008, Senators Migden and Perata authored  
          SB 1713, an almost identical bill to SB 797.  SB 1713 failed  
          passage on the Assembly floor.  
           
           Double referral  :  This bill was double-referred by the Assembly  
          Rules Committee to the Assembly Health Committee.  
           
           REGISTERED SUPPORT / OPPOSITION  :
           
          SUPPORT

           Environmental Working Group (sponsor)
          Alliance of California Autism Organizations
          Asian Health Services
          Asian Law Caucus 
          Breast Cancer Fund
          Breastfeeding Task Force of Greater Los Angeles
          California Association of Sanitation Agencies (CASA)
          California League of Conservation Voters (CLCV)
          California Nurses Association 
          California Nurses Foundation
          California State PTA
          California Teamsters Public Affairs Council
          California Public Interest Research Group (CALPIRG)
          California WIC Association
          Clean Water Action
          Commonweal
          Consumer Federation of California  
          Consumers Union
          County of Los Angeles 
          County of Marin Board of Supervisors
          County of Santa Clara Board of Supervisors
          County and City of San Francisco
          Diane Feinstein, United State Senator
          Environment California
          Environmental Working Group
          Heal the Bay
          Healthy Child Healthy World
          Making Our Milk Safe (M.O.M.S.)
          Mothers of Marin Against the Spray 








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          Natural Resource Defense Council
          Physicians for Social Responsibility: Los Angeles
          Planned Parenthood Affiliates of California
          Planning and Conservation League 
          San Diego Coast Keeper 
          Service Employees International Union (SEIU)
          Sierra Club, California
          The Women's Foundation of California
          Zero Breast Cancer

           OPPOSITION

           American Chemistry Council
          California Chamber of Commerce
          California Citizens Against Lawsuits Abuse
          California Council for Environmental and Economic Balance
          California Grocers Association 
          California League of Food Processors
          California Manufacturers and Technology Association
          Can Manufacturers Institute 
          Chemical Industry Council of California
          Civil Justice Association of California 
          Consumer Specialty Products Association
          Grocery Manufacturers Association 
          Industrial Environmental Association
          International Formula Council 
          Juvenile Products Manufacturers Association
          North American Metal Packaging Alliance, INC. (NAMPA)
          Pharmaceutical Research and Manufacturers of American (PhRMA)
          Santa Barbara Technology and Industry Association


           Analysis Prepared by  :    Shannon McKinney / E.S. & T.M. / (916)  
          319-3965