BILL ANALYSIS Ó SENATE HEALTH COMMITTEE ANALYSIS Senator Ed Hernandez, O.D., Chair BILL NO: AB 1319 A AUTHOR: Butler B AMENDED: May 10, 2011 HEARING DATE: June 15, 2011 1 REFERRAL: Environmental Quality 3 CONSULTANT: 1 Orr 9 SUBJECT Product safety: bisphenol A SUMMARY Enacts the Toxin-Free Infants and Toddlers Act, prohibiting the sale, manufacture, or distribution of any infant formula, liquid, baby food, or beverage 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. Continued--- STAFF ANALYSIS OF ASSEMBLY BILL 1319 (Butler) Page 2 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 cadmium. 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. STAFF ANALYSIS OF ASSEMBLY BILL 1319 (Butler) Page 3 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 population. 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 regulations. 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 BPA. 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 asserts that while most consumers believe that everyday STAFF ANALYSIS OF ASSEMBLY BILL 1319 (Butler) Page 4 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. BPA 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. BPA exposure STAFF ANALYSIS OF ASSEMBLY BILL 1319 (Butler) Page 5 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 material. 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 concern for infants. STAFF ANALYSIS OF ASSEMBLY BILL 1319 (Butler) Page 6 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 halt sales of baby bottles, "sippy cups," pacifiers, food STAFF ANALYSIS OF ASSEMBLY BILL 1319 (Butler) Page 7 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 (Cal/EPA) 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 establishing a comprehensive Green Chemistry program in STAFF ANALYSIS OF ASSEMBLY BILL 1319 (Butler) Page 8 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 valid concerns from the chemicals industry, environmental STAFF ANALYSIS OF ASSEMBLY BILL 1319 (Butler) Page 9 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 a issues pertaining to the earlier aspects of the process in the regulations: Product Identification and Prioritization, Chemical identification and prioritization , and De Minimis and Unintentionally-Added Chemicals. 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 miscarriages, obesity, and polycystic ovarian disease. STAFF ANALYSIS OF ASSEMBLY BILL 1319 (Butler) Page 10 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 and beverage containers. In August 2010, the Maine Board STAFF ANALYSIS OF ASSEMBLY BILL 1319 (Butler) Page 11 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 passage on the Assembly 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 specified. 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 heard in the Senate Health Committee, but was cancelled at STAFF ANALYSIS OF ASSEMBLY BILL 1319 (Butler) Page 12 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. PRIOR ACTIONS STAFF ANALYSIS OF ASSEMBLY BILL 1319 (Butler) Page 13 Assembly Environmental Safety and Toxic Materials:6- 2 Assembly Health: 12- 7 Assembly Floor: 42- 29 COMMENTS 1. Double Referral. This bill has also been referred to the Senate Environmental Quality Committee. POSITIONS Support: Black Women for Wellness (co-sponsor) Consumers Union (co-sponsor) Environmental Working Group (co-sponsor) Physicians for Social Responsibility-Los Angeles (co-sponsor) Alliance of California Autism Organizations American Academy of Pediatrics, California The American Congress of Obstetricians and Gynecologists 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 Commonweal 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 Great Beginnings for Black Babies STAFF ANALYSIS OF ASSEMBLY BILL 1319 (Butler) Page 14 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 County 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 Association 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 --