BILL ANALYSIS                                                                                                                                                                                                    

                                 SENATE HEALTH
                               COMMITTEE ANALYSIS
                       Senator Ed Hernandez, O.D., Chair

          BILL NO:       AB 1319                                     
          AUTHOR:        Butler                                      
          AMENDED:       May 10, 2011                                
          HEARING DATE:  June 22, 2011                               
          REFERRAL:      Environmental Quality                       

                          Product safety: bisphenol A


          Enacts the Toxin-Free Infants and Toddlers Act, prohibiting 
          the sale, manufacture, or distribution of any infant 
          formula, liquid, baby food, beverage, baby bottle or cup 
          intended primarily for children under three, that contains 
          bisphenol A (BPA) on or after July 1, 2013, as specified.

                             CHANGES TO EXISTING LAW  

          Existing law:
          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 in 
          concentrations exceeding 0.1 percent.  Defines a "child 
          care article" as all products designed or intended by the 
          manufacturer to facilitate sleep, relaxation, or the 
          feeding of children, or to help children with sucking or 
          teething.  Requires manufacturers to use the least toxic 
          alternative when replacing phthalates in products.


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

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

          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.
          Under the Safe Drinking Water and Toxic Enforcement Act of 
          1986 (commonly known as Proposition 65), requires the 
          Governor to publish and annually revise a list of chemicals 
          that have been scientifically proven to cause cancer or 
          reproductive toxicity each year. Prohibits any person in 
          the course of doing business in California from knowingly 
          exposing any individual to a chemical known to the state to 
          cause cancer or reproductive toxicity.

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

          Prohibits the sale of children's jewelry containing lead or 
          This bill:
          Enacts the Toxin-Free Infants and Toddlers Act, prohibiting 
          the sale, manufacture, or distribution in commerce of any 
          bottle or cup that contains BPA at a level above 0.1 parts 
          per billion (ppb), if its primary intent is to be filled 
          with liquids, foods, or beverages for infants or children 
          three years of age or younger, on and after July 1, 2013. 

          Prohibits the sale, manufacture, or distribution of any 
          infant formula, liquid, baby food, or beverage containing 
          BPA at a level above 0.1 ppb if its primary intent is to be 
          consumed by infants or children three years of age or 
          younger, on and after July 1, 2013.


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          Exempts medical devices, as defined, and food and beverage 
          containers designed or intended primarily to contain 
          liquid, food, or beverages for consumption by the general 

          Requires that the maximum amount of BPA allowable be based 
          on the infant formula, liquid, baby food, or beverage as it 
          is intended or directed to be consumed.

          Requires that the above provisions no longer be implemented 
          if the Department of Toxic Substances Control (DTSC) adopts 
          regulations regarding the use of BPA in an abovementioned 
          item and DTSC posts a notice on its web site regarding the 

          Specifies that these provisions are not intended to 
          prohibit or restrict DTSC from adopting regulations to 
          limit exposure to or reduce the level of hazard posed by 

          Requires manufacturers to use the least toxic alternative 
          when replacing BPA in items specified by this bill. 

          Prohibits manufacturers from replacing BPA with carcinogens 
          or reproductive toxicants as identified by the US EPA or 
          listed in the Safe Drinking Water and Toxic Enforcement Act 
          of 1986, as specified. 

          Makes a number of findings and declarations related to BPA, 
          its pervasiveness in humans and the environment, and its 
          health effects.

                                 FISCAL IMPACT  

          This bill is keyed non-fiscal.

                            BACKGROUND AND DISCUSSION  

          According to the author, AB 1319 is a child safety measure 
          that seeks to protect infants and toddlers from a harmful 
          toxin that leaches into babies' milk and food.  The author 


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          asserts that while most consumers believe that everyday 
          products are tested for dangerous chemicals and determined 
          to be safe by government authorities, the reality is that 
          many children's products contain toxic chemicals, such as 
          BPA, 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, the author claims 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, which indicate 
          that BPA leaches into food and beverage products and is 
          toxic at even extremely low doses.

          The author believes it is in the best interest of 
          California to reduce infants' and toddlers' exposure to BPA 
          as soon as possible. The author argues that California's 
          Green Chemistry program will not come to fruition soon 
          enough to protect the 550,000 babies born in California 
          each year from the health risks of BPA. Furthermore, the 
          author claims that infant formula and baby food is exempted 
          by law from the Green Chemistry program. 

          According to the federal Centers for Disease Control and 
          Prevention (CDC), BPA is used to manufacture polycarbonate 
          plastics. This type of plastic is used to make a wide 
          variety of consumer products, including some types of 
          beverage and food containers, compact disks, plastic 
          dinnerware, impact-resistant safety equipment, including 
          shatter-resistant baby bottles, automobile parts, 
          sunglasses and toys. BPA epoxy resins are often used in the 
          protective linings of food cans, in dental sealants, and in 
          other products. 

          BPA has been used for more than 40 years in the manufacture 
          of many hard plastic food containers such as baby bottles 
          and reusable cups as well as the lining of metal food and 
          beverage cans, including canned liquid infant formula.  
          Trace amounts of BPA can be found in some foods packaged in 
          these containers.


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          BPA exposure
          General exposure to BPA at low levels comes from eating 
          food or drinking water stored in containers that have BPA. 
          Small children may be exposed by hand-to-mouth and direct 
          oral contact with materials containing BPA. Dental 
          treatment with BPA-containing sealants also results in 
          short-term exposure. In addition, workers who manufacture 
          products that contain BPA can be exposed.

          According to a National Toxicology Program (NTP) Draft 
          Brief on BPA issued in April of 2008, diet is the primary 
          source of exposure to BPA for most people, although air, 
          dust, and water (including skin contact) are also possible 
          sources of exposure.  According to the NTP, BPA can migrate 
          into food from containers with internal epoxy resin 
          coatings and from polycarbonate plastic products such as 
          baby bottles, tableware, food containers, and water 
          bottles.  The degree to which BPA migrates from 
          polycarbonate containers into liquid appears to depend more 
          on the temperature of the liquid than the age of the 
          container, and higher temperatures cause more migration.  
          Short-term exposure can occur following application of 
          certain dental sealants or composites made with BPA-derived 

          According to the NTP Draft Brief, the highest estimated 
          daily intakes of BPA in the general population occur in 
          infants and children because, relative to their size, they 
          eat, drink, and breathe more than adults.  The CDC found 
          detectable levels of BPA in 93 percent of a large, 
          representative sample of people six years and older.  
          People with the lowest household incomes had higher levels 
          of BPA than people in the highest income bracket.  

          The NTP Draft Brief cited estimates that formula-fed 
          infants younger than six months and infants six to twelve 
          months had much higher intake levels of BPA than breast-fed 
          infants less than six months of age, and higher than adults 
          in the general population, due to polycarbonate formula 
          bottles, epoxy formula can linings, canned foods, and 
          polycarbonate tableware.  Baby's Toxic Bottle, a February 
          2008 report released by a coalition of U.S. and Canadian 
          public health and environment groups, concluded that the 
          amount of leaching from heated baby bottles is within the 
          range to cause harm in animals and is therefore a health 


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          concern for infants.  

          Health impacts of BPA
          NTP states that it is difficult to draw conclusions about 
          developmental or reproductive effects of BPA from human 
          studies due to factors such as lack of variation in 
          exposure, small sample size or lack of adjustment for 
          potential confounders.  However, a group of scientists 
          convened by the National Institutes of Health have 
          concluded that animal studies of BPA should be considered a 
          valid indicator of potential harm to humans.  

          NTP finds that there is some concern for neural and 
          behavioral effects in fetuses, infants, and children at 
          current human exposures to BPA.  NTP also has some concern 
          for effects in the prostate gland, mammary gland, and early 
          onset of puberty in females associated with BPA exposure to 
          fetuses, infants, and children.  Also, NTP did not find 
          sufficient evidence to rule out the possibility that BPA 
          exposure is associated with obesity and diabetes, decreased 
          sperm production and motility, and abnormal sperm formation 
          associated with infertility.  

          NTP concluded that several human studies, including one in 
          occupationally exposed male workers, collectively suggest 
          hormonal effects of BPA exposure in adults.  Examples of 
          hormonal effects of BPA include increased testosterone in 
          men and women, polycystic ovary syndrome, recurrent 
          miscarriages, and chromosomal defects in fetuses.  In 
          laboratory animals, developmental exposure to BPA at doses 
          comparable to human exposures appear to cause changes that 
          may increase the risk of breast cancer later in life.  NTP 
          expressed negligible concern that exposure of pregnant 
          women to BPA will result in fetal or neonatal mortality, 
          birth defects or reduced birth weight and growth in their 
          offspring.  NTP has negligible concern that nonoccupational 
          exposure to BPA has reproductive effects and minimal 
          concern that occupational exposures to BPA cause 
          reproductive harm.

          Reduced use of BPA 
          Numerous manufacturers and retailers have decreased or 
          halted sales of children's products containing BPA, and 
          quickly increased the availability of BPA-free products.  
          Wal-Mart announced in April 2008 that it would immediately 


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          halt sales of baby bottles, "sippy cups," pacifiers, food 
          containers, and water bottles made with BPA in its Canadian 
          stores, and that it would stop selling baby bottles made 
          with BPA in its U.S. stores in early 2009.  Toys "R" Us 
          also announced it would stop selling baby bottles and other 
          baby feeding products containing BPA by the end of 2008.  
          Whole Foods has stopped selling polycarbonate baby bottles 
          and child drinking cups.  Eden Foods has eliminated BPA in 
          cans for some foods.  According to the Milwaukee Journal 
          Sentinel, gas and chemical maker, Sunoco, citing 
          uncertainty over the safety of BPA, announced in March 2009 
          that it will require its customers to guarantee that they 
          will not use BPA in food and water containers for children 
          under three years.  

          California's Green Chemistry Initiative 
          For the last century, environmental protection has 
          concentrated on storing and disposing hazardous waste. 
          Green chemistry is a fundamentally new approach to 
          environmental protection, transitioning away from managing 
          toxic chemicals at the end of the lifecycle, to reducing or 
          eliminating the toxicity of chemicals from the start. Green 
          chemistry is the design of chemical products and processes 
          that reduce or eliminate the use or generation of hazardous 
          substances. Green chemistry applies across the life cycle 
          of a chemical product, including its design, manufacture, 
          and use.  It intends to address chemicals before they 
          become hazards, with the goal of making chemicals and 
          products "benign by design." 

          The California Green Chemistry Initiative (Initiative) was 
          launched in April 2007 as a collaborative arrangement with 
          the California Environmental Protection Agency (CalEPA) 
          boards, departments and offices, as well as other state 
          agencies. The initiative seeks to identify options to 
          significantly reduce the impacts of toxic chemicals on 
          public health and the environment, and its purpose is to 
          develop policy options for implementing green chemistry 
          principles and promote better coordination of laws intended 
          to manage single chemicals.  As the lead agency for the 
          Initiative, DTSC has conducted a broad public process to 
          generate ideas and develop overall policy goals, and has 
          made recommendations for a comprehensive green chemistry 
          policy framework for the state.  In December 2008, the 
          Initiative released six policy recommendations for 


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          establishing a comprehensive Green Chemistry program in 
          California, of which Governor Schwarzenegger signed two 
          into law:  
                 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.
          DTSC completed a two-year process of stakeholder and public 
          involvement and issued a draft regulation in June 2010.  
          DTSC submitted a proposed regulation to the Office of 
          Administrative Law (OAL) in September 2010 that included 
          changes made as a result of the stakeholder and public 
          input process.  The Green Chemistry Proposed Regulation for 
          Safer Consumer Products was submitted to the state OAL to 
          begin the official rulemaking process.  In December 2010, 
          the California Office of Environmental Health Hazard 
          Assessment (OEHHA) released proposed regulations that seek 
          to implement the mandate of SB 509 and identify four 
          general categories of hazard traits: 
                 Toxicological Hazard Traits; 
                 Environmental Hazard Traits; 
                 Exposure Potential Hazard Traits; and, 
                 Physical Hazard Traits.

          Status of the Green Chemistry Initiative
          AB 1879 (Feuer), Chapter 559, Statutes of 2008, required 
          DTSC to adopt regulations by January 1, 2011, to: (1) 
          establish a process by which chemicals or chemical 
          ingredients in products may be identified and prioritized 
          for consideration as being chemicals of concern, and (2) 
          adopt regulations to establish a process by which chemicals 
          of concern in products, and their potential alternatives, 
          are evaluated to determine how best to limit exposure or to 
          reduce the level of hazard posed by a chemical of concern. 

          In a letter to Assemblymember Mike Feuer in December 2010, 
          CalEPA Secretary Linda Adams claims that the most recent 
          draft of green chemistry regulations raised substantive and 


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          valid concerns from the chemicals industry, environmental 
          groups, scientists and legislative leaders. As a result, 
          Secretary Adams requested that DTSC take additional time to 
          be responsive to the concerns raised, and that DTSC 
          reconvene the Green Ribbon Science Panel early in 2011 to 
          further vet the programmatic issues that were brought to 
          DTSC's attention via the public comment process.  In March 
          2011, Secretary Adams hosted stakeholder meetings to hear 
          concerns and to discuss next steps.  The Green Ribbon 
          Science Panel has essentially been asked to start over and 
          has now organized itself into three subcommittees to 
          address any issues pertaining to the earlier aspects of the 
          process in the regulations: 
                           Product Identification and 
                           Chemical identification and 
                    prioritization , and
                           De Minimis and Unintentionally-Added 

          Each subcommittee met twice in April this year, and the 
          issues discussed in the subcommittees were further 
          discussed at the full Green Ribbon Science Panel meeting 
          this past May. DTSC now hopes to issue new draft 
          regulations by August of this year.

          Legislative hearings on toxics
          In January 2006, the Assembly Environmental Safety and 
          Toxic Materials Committee and the Assembly Health Committee 
          held a joint informational hearing on the health effects of 
          phthalates and BPA on children.  During the hearing, the 
          manufacturers and industries that use phthalates and BPA in 
          children's products claimed that the levels at which people 
          are exposed to these chemicals pose no risk.  A leading 
          researcher on the effects of BPA testified on the 
          similarities between effects of low doses of BPA on 
          laboratory animals and human health trends, such as 
          prostate disease, obesity, decreased sperm counts, early 
          puberty in females, and hyperactivity.  The researcher also 
          testified that industry-funded studies show no health 
          effects of BPA exposure, while government-funded studies 
          generally show effects.  The researcher showed that low 
          doses, not high doses, of BPA stimulate proliferation of 
          human prostate cancer cells, and that elevated levels of 
          BPA in the blood are associated with recurrent 


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          miscarriages, obesity, and polycystic ovarian disease. 

          In February 2009, August 2010, and February 2011, the 
          Assembly Committees on Environmental Safety and Toxic 
          Materials, Health, and Natural Resources held oversight 
          hearings on the Green Chemistry Initiative.  
          Representatives from DTSC and OEHHA reported on their 
          progress in implementing Green Chemistry.  
          Other actions on BPA
          In January 2010, the federal Food and Drug Administration 
          (FDA) announced that, on the basis of results from recent 
          studies using novel approaches to test for subtle effects, 
          both the NTP at the National Institutes of Health and the 
          FDA have some concern about the potential effects of BPA on 
          the brain, behavior, and prostate gland in fetuses, 
          infants, and young children.  The FDA stated that it would 
          carry out in-depth studies to answer key questions and 
          clarify uncertainties about the risks of BPA in cooperation 
          with the NTP and FDA's National Center for Toxicological 
          Research.  In March 2010 the EPA declared BPA a "chemical 
          of concern." It later announced it would initiate an 
          assessment under its Design for the Environment (DfE) 
          program, to encourage reductions in BPA releases and 
          exposures. The DfE environmental and health assessment is 
          expected to be completed in the latter half of 2011.  

          There have also been attempts in Congress to ban BPA.  In 
          2009, U.S. Senators Dianne Feinstein and Chuck Schumer 
          introduced S. 593 and Congressman Edward Markey introduced 
          H.R. 1523 to establish a federal ban on BPA in all food and 
          beverage containers.  Congressman John Dingell also 
          introduced the federal Food Safety Enhancement Act, H.R. 
          2749, which would have required the Secretary of the U.S. 
          Department of Health and Human Services to examine the 
          evidence concerning BPA. 
          In October 2008, the Canadian government announced that it 
          would ban the use of BPA in baby bottles, and take measures 
          to limit the release of BPA in the environment.  In March 
          2009, Suffolk County, New York became the first place in 
          the nation to enact a BPA ban.  Minnesota has also banned 
          BPA in baby bottles and cups, and in June 2009 Connecticut 
          acted to ban BPA in all children's feeding products, 
          including formula cans, and the full range of reusable food 


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          and beverage containers.  In August 2010, the Maine Board 
          of Environmental Protection voted unanimously to ban the 
          sale of baby bottles and other reusable food and beverage 
          containers made with BPA as of January 2012.
          The European Food Safety Authority, however, and the United 
          Kingdom Food Standards Agency recently reaffirmed their 
          position that BPA is safe at a daily intake below 0.05 
          milligrams/kilogram of body weight.  

          Prior legislation
          SB 797 (Pavley) of the 2009-10 Session was substantially 
          similar to this bill. SB 797 failed concurrence on the 
          Senate Floor. 
          SB 509 (Simitian), Chapter 560, Statutes of 2008, requires 
          DTSC to establish a Toxics Information Clearinghouse, as 
          specified, and defines terms relating to a Green Chemistry 
          program to be administered by DTSC.
          SB 1713 (Migden) of 2008 contained provisions similar to 
          this bill and would have prohibited the sale, manufacture 
          or distribution in commerce of food containers for children 
          that contain BPA above a specified level.  SB 1713 failed 
          passage on the Assembly Floor.
          AB 1879 (Feuer), Chapter 559, Statutes of 2008, requires 
          DTSC, by January 1, 2011, to adopt regulations to establish 
          a process to identify and prioritize chemicals or chemical 
          ingredients in products that may be considered a "chemical 
          of concern," in accordance with a review process, as 

          AB 1108 (Ma), Chapter 672, Statues of 2007, prohibits the 
          use of phthalates in toys and childcare products designed 
          for babies and children under three years of age.
          AB 2694 (Ma) of the 2007-2008 Session would prohibit a 
          person, firm, or corporation from manufacturing, selling, 
          or exchanging, having in his or her possession with intent 
          to sell or exchange, or expose, or offer for sale or 
          exchange to any retailer, any toy or child care article or 
          any other product intended for use by, or for the care of, 
          a child 12 years of age or younger, that contains a 
          lead-bearing substance, as defined.  AB 2694 was set to be 


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          heard in the Senate Health Committee, but was cancelled at 
          the request of the author.
          Arguments in support 
          Several supporters, including Environment California, Great 
          Beginnings for Black Babies, the US Autism and Asperger 
          Association, and the Silicon Valley Toxics Coalition, all 
          claim that there are many alternatives for the products 
          that are the subjects of AB 1319, and some major 
          manufacturers have already taken the responsible path 
          toward eliminating these hazards from their products. They 
          believe that AB 1319 will help ensure that products laden 
          with BPA are not channeled towards poorer communities.  

          The American Academy of Pediatrics, California (AAP-CA) 
          believes that while it is difficult to establish a causal 
          link, existing and emerging data are sufficient to warrant 
          banning BPA in products that are used for food consumption 
          by infants and children including infant formula and baby 
          food. The California WIC (Women, Infants and Children 
          program) Association believes that while breastfeeding is 
          best for infants, proper nutrition for infants should 
          strive to be BPA-free. To enforce that belief, CA WIC 
          provides BPA-free powdered infant formula to WIC clients.  
          CA WIC notes that WIC recipients often shop in discount 
          stores, which are least likely to sell BPA-free products.
          Arguments in opposition
          Several opponents, including the California Chamber of 
          Commerce, the Consumer Specialty Products Association and 
          the American Chemistry Council, all believe AB 1319 runs 
          contrary to the consensus of the scientific community and 
          of international regulatory agencies that have concluded 
          that BPA is safe as used. Opponents assert that the FDA has 
          not recommended that families change the use of infant 
          formulas or foods, because the benefit of a stable source 
          of good nutrition outweighs the potential risk of BPA 
          exposure.  Opponents also claim that BPA does not 
          accumulate in the body and is rapidly eliminated in urine. 
          Opponents dispute the notion that alternatives are readily 
          available, and claim that any alternative coating is merely 
          a candidate material until safety and performance are 
          thoroughly evaluated. 


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                                  PRIOR ACTIONS

           Assembly Environmental Safety and Toxic Materials:6- 2
          Assembly Health:                        12- 7
          Assembly Floor:                         42- 29

          1.  Double Referral.  This bill has also been referred to 
          the Senate Environmental Quality Committee.

          Support:  Black Women for Wellness (co-sponsor)
                    Consumers Union (co-sponsor)
                    Environmental Working Group (co-sponsor) 
                    Physicians for Social Responsibility-Los Angeles 
                    Alliance of California Autism Organizations 
                    American Academy of Pediatrics, California
                    The American Congress of Obstetricians and 
                    Asian Communities for Reproductive Justice 
                    Autism One 
                    Autism Research Institute 
                    Breast Cancer Fund 
                    California League of Conservation Voters 
                    California Medical Association 
                    California Nurses Association
                    California WIC Association 
                    Californians for a Healthy & Green Economy 
                    Center For Environmental Health     
                    Children Now 
                    Clean Water Action
                    Consumer Federation of California
                    County of Los Angeles Board of Supervisors 
                    County of Santa Clara Board of Supervisors 
                    EcoMom Alliance 
                    Environment California 
                    First 5 Fresno County
                    First 5 LA 
                    Food & Water Watch Green to Grow 


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                    Great Beginnings for Black Babies 
                    Healthy Child Healthy World 
                    Los Angeles County Board of Supervisors
                    Making Our Milk Safe (MOMS) 
                    Moms Advocating Sustainability 
                    Natural Resource Defense Council 
                    Planned Parenthood Advocacy Project Los Angeles 
                    Planned Parenthood Affiliates of California
                    Planning and Conservation League
                    Reproductive Justice Association of Los Angeles 
                    SF Environment 
                    Sierra Club of California 
                    Silicon Valley Toxics Coalition 
                    St. John's Well Child and Family Center 
                    Teens Turning Green 
                    U.S. Autism & Asperger Association 
                    United States Senator Dianne Feinstein 
                    One individual

          Oppose:AdvaMed- Advanced Medical Technology Association
                    American Chemistry Council
                    California Chamber of Commerce
                    California Citizens Against Lawsuit Abuse
                    California Grocers Association
                    California Healthcare Institute
                    California League of Food Processors\
                    California Manufacturers and Technology 
                    Can Manufacturers Institute
                    Civil Justice Association of California
                    Consumer Specialty Products Association
                    Grocery Manufacturers Association
                    Industrial Environmental Association
                    International Formula Council
                    Juvenile Products Manufacturers Association
                    National Federation of Independent Business
                    North American Metal Packaging Alliance, Inc.

                                   -- END --


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