BILL ANALYSIS SB 797 Page 1 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. SB 797 Page 2 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. SB 797 Page 3 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 SB 797 Page 4 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. SB 797 Page 5 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. SB 797 Page 6 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 SB 797 Page 7 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 SB 797 Page 8 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). SB 797 Page 9 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 SB 797 Page 10 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