STAFF ANALYSIS OF ASSEMBLY BILL 1319 (Butler)Page 1

SENATE HEALTH

COMMITTEE ANALYSIS

Senator Ed Hernandez, O.D., Chair

BILL NO: AB 1319A

AUTHOR: ButlerB

AMENDED: May 10, 2011

HEARING DATE: June 22, 20111

REFERRAL:Environmental Quality3

CONSULTANT:1

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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, 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.

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 EnvironmentalProtection 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.

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 provisionsno 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 EPAor listed in theSafe 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 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’sGreen 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

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 93percent 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.

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 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 MilwaukeeJournal 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 theybecome hazards, with the goal of making chemicals and products “benign by design.”

The California GreenChemistry 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 principlesand promote better coordination of laws intended to manage single chemicals. As the lead agency for the Initiative, DTSChas conducted a broad public process togenerate 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 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 letterto 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 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 anyissues 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, theAssembly 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.

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.