Bottles, Cans, and Bans The Latest Dispatch from the BPA Battlefields

Transcription

1 Bottles, Cans, and Bans The Latest Dispatch from the BPA Battlefields Timothy J. Coughlin Thompson Hine LLP 3900 Key Center 127 Public Square Cleveland, Ohio (216) (216) [fax] Return to course materials table of contents

2 Timothy J. Coughlin is a partner in Thompson Hine s product liability and business litigation practice groups. He is chair of the firm s mass and toxic tort group. He focuses his litigation practice on mass toxic tort, product liability, and commercial litigation on a national basis. Tim has represented clients in more than 23 states and Canada. Tim is the lead counsel for a number of chemical companies and the industry trade association on national litigation involving chemical exposures.

3 Bottles, Cans, and Bans The Latest Dispatch from the BPA Battlefields Table of Contents I. Introduction A. What Is BPA? B. What Is the Concern? II. The Science A. BPA Exposures B. BPA in Humans C. Animal Studies Reproductive and development effects Neurological effects Immunological effects Carcinogenic effects D. Health Effects in Human Studies III. Governmental Regulation and Positions A. The U.S. NTP B. U.S. EPA C. U.S. FDA IV. Current and Pending Legislation and Banning A. United States B. Canada C. France D. Denmark V. Litigation Attachment Bottles, Cans, and Bans The Latest Dispatch from the BPA Battlefields v Coughlin v 531

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5 Bottles, Cans, and Bans The Latest Dispatch from the BPA Battlefields I. Introduction Bisphenol A ( BPA ) is the subject of ever-increasing scrutiny by both consumer groups and governmental bodies in the U.S. and abroad. In some countries, legislation has been passed banning BPA s use in products targeted for use by infants and children. Similar legislation is currently being proposed or has been passed in a number of states, and the list of states considering such legislation is ever expanding. This legislation raises concerns in numerous legal fields such as product liability, consumer protection law, and governmental regulation. Consumers, through various media outlets, are becoming more aware of alleged toxic effects of products containing BPA, with particular attention being paid to products produced for infants and children. As the wave of concern, scientifically justified or not, about alleged product safety swells, manufacturers and distributors of these products and their components could become targets for litigation or banning legislation. A. What Is BPA? BPA is a hardening additive that is used primarily to make polycarbonate plastic and epoxy resins. Polycarbonate plastics are used in a number of applications, including medical equipment, bicycle helmets, safety glasses, automobile bumpers, compact discs and DVDs, and most notably, baby bottles and sippy cups. Epoxy resins are used in many coatings and other applications, including protective liners in metal cans for canned foods and beverages. Given the variety of products that may contain BPA, it is important for manufacturers to determine whether their products contain BPA and be aware of studies that are driving the current attention to its use and legislative reaction. B. What Is the Concern? BPA s molecular shape may mimic estrogen, the female hormone. Some studies reportedly show that BPA, at a sufficiently high dose, acts as an endocrine-disruptor in animals, including early onset of sexual maturation, altered development and tissue organization of the mammary gland and decreased sperm production in offspring. Other studies reportedly suggest that BPA may be most harmful in the stages of early development. Previous U.S. reports estimate that over 90 percent of Americans have BPA trace residues in their bodies, and that trace amounts of the chemical are transferred from food and beverage containers, especially when the plastic is heated, exposed to strong dishwashing chemicals, or comes into contact with acidic substances. A recent Harvard study also reports that BPA leaches into cold beverages during normal consumption and that BPA levels in the urine of test subjects were significantly raised during regular consumption from BPA-containing products. (Carwile et al., 2009) Yet studies have consistently shown that BPA is noncarcinogenic at levels currently experienced by consumers. Concern regarding the chemical surged, however, in September The National Toxicology Program s ( NTP ) Center for the Evaluation of Risks to Human Reproduction issued a monograph on BPA stating that low-dose studies of BPA provide limited evidence of adverse effects on development in laboratory animals. The monograph went on to state, however, that there is some concern about Bottles, Cans, and Bans The Latest Dispatch from the BPA Battlefields v Coughlin v 533

6 the effects of BPA on the brain, behavior, and prostrate gland of fetuses, infants, and children at current human exposures levels. It is this statement that has led to an increase in both legislation and litigation in the U.S and abroad. II. The Science A. BPA Exposures Under normal circumstances humans are exposed to very low doses of BPA. Most human exposure occurs from residues contained in food or beverages that have been in contact with the two main products manufactured with BPA: polycarbonate plastic, which is used in water bottles, baby bottles, tableware and food storage containers; and epoxy resins, which provide a protective lining in food and beverage cans to prevent contamination. Despite contact with packaging and containers, the concentrations of BPA in food and beverages are very low. This fact, in addition to the low toxicity of BPA, means that the risk to humans from BPA exposure in food and beverages is low. (Goodman, 2009; Goodson et al., 2002) B. BPA in Humans Since humans efficiently convert BPA into rapidly excreted, toxicologically inactive forms, BPA does not accumulate after ingestion. Human exposure to BPA can be estimated based on measurements 534 v DRI Annual Meeting v October 2010

7 of BPA in serum, plasma, and urine. BPA levels in urine are a more reliable biomarker of human exposure. (Goodman, 2009; Pritchett et al., 2002) C. Animal Studies In 1997, scientists from Fredrick vom Saal s laboratory reported that young mice that had been exposed to low levels of BPA in utero (through oral dosing of pregnant mice) had increased prostate weights. (Nagel et al., 1997) This led to the lowdose hypothesis; namely, exceedingly low doses of BPA could lead to developmental and reproductive health effects that might not be observed at higher doses. With the exception of a minority view (vom Saal and Hughes, 2005; vom Saal et al., 2007), there is a clear international consensus about safe dose levels and the enormous gap between demonstrably toxic levels for any endpoint and human exposure levels. (Goodman, 2009) 1. Reproductive and development effects BPA may mimic estrogen at very high doses. (Hughes, 2005; Goodman et al., 2006, 2008; vom Saal et al, 2007) Because humans are exposed to quite low doses of BPA (~ ug/kg/day in adults based on urine biomonitoring), animal studies of low doses (e.g., <5 mg/kg/day) are more relevant for determining risks to human health than studies with higher animal doses. Based on more than 130 reproductive and developmental studies (and several dozen supporting studies) conducted in animals with dose <5mg/kg/day and an examination of the whole body of evidence endpoint by endpoint, there is an overwhelming preponderance of lack-of-effect findings compared with findings of effect, over a wide variety of reproductive and developmental toxicity and points. (Gray et al., 2004; Goodman et al., 2006, 2008) 2. Neurological effects There is no consistent evidence that low doses of BPA cause adverse effects on behavioral endpoints, including 1) sensory/motor behaviors and reflexes (e.g., Ema et al., 2001; Palanza et al., 2002); 2) frequently measured gross behaviors of ambulation, rearing, grooming, and defecation (e.g., Farabollini et. al. 1999; Ema et al., 2001; 3) complex cognitive behaviors (e.g., Ema et al., 2001; Kubo et al., 2001; Carr et al., 2003; Negishi et al., 2003, 2004); 4) complex emotional behaviors such as impulsivity, anxiety, and pain perception (e.g., Farabollini et al., 1999; Sashihara et al., 2001; Aloisi et al., 2002; Adriani et al., 2003); and 5) social behaviors such as play, aggression, maternal behavior, and sexual behavior (Farabollini et al., 1999, 2002; Dessi-Fulgheri et al., 2002; Palanza et al., 2002; Kawai et al., 2003; Kubo et al., 2003). Some studies suggest that low BPA doses cause masculinization of female behavior or feminization of male behavior on individual measures, but there has been no convincing or consistent pattern of effect that supports this conclusion. (e.g., Farabollini et al., 1999, 2002; Kubo et al., 2001; Dessi-Fulgheri et al., 2002; Adriani et al., 2003) 3. Immunological effects Because there are natural interactions between the immune system and estrogens, several investigators have studied whether BPA can alter immune function. The data are currently insufficient for Bottles, Cans, and Bans The Latest Dispatch from the BPA Battlefields v Coughlin v 535

8 drawing firm conclusions about possible immunological effects at relatively low doses (such as those experienced by humans). In light of several multigenerational studies reporting no pathology indicative of immune system dysfunction at low doses (Ema et al., 2001; Tyl et al., 2002, 2008), the findings reported in these studies are unlikely to be indicative of potential human risks. 4. Carcinogenic effects Because BPA may mimic an estrogenic effect, several researchers have examined whether it could also be carcinogenic. BPA was first tested for carcinogenicity by the U.S. National Toxicology Program ( NTP ) in a lifetime feeding bioassay using rats and mice. The NTP report concluded that [u] nder the conditions of this bioassay, there was no convincing evidence that BPA was carcinogenic for F344 rats or B6C3F1 mice of either sex. (NTP, 1982) Based on the available data, none of the prominent governmental and international organizations classify BPA as a carcinogen. The NTP, in its latest (11th) edition of the NTP Report on Carcinogens (NTP, 2005), does not list BPA as a carcinogen, nor does the International Agency for Research on Cancer ( IARC ), a division of the World Health Organization, nor does the U.S. EPA in its Integrated Risk Information System (IRIS; U.S. EPA, 1993). The European Union also concludes that BPA has no carcinogenic potential, based on the results of the NTP study. (EU, 2003) D. Health Effects in Human Studies There have been few completed studies focused on the possible health effects of BPA in humans. Thus far, Sugiura-Ogasawara et al. (2005) examined miscarriages, Takeuchi and Tstsumi (2002) and Takeuchi et al. (2004) studied polycystic ovarian syndrome and obesity, Hiroi et al. (2004) evaluated endometrial hyperplasia and endometrial cancer, Yamada et al. (2002) examined chromosomal abnormalities in fetuses, and Yang et al. (2006) studied reproductive parameters (number of children and ratio of sons to daughters), self-reported endocrine-related symptoms, and chromosomal abnormalities. All these studies have major methodological shortcomings, which makes their results difficult to interpret. All studies were based on one BPA measurement per person. Because of the short half-life of BPA, the degree of exposure over the putative period of causation of the observed effects is unknown. It is also doubtful that BPA measurements in all of these studies were accurate. (Goodman, 2009) Sugiura-Ogasawarea et al. (2005) compared miscarriages in cases and controls and median BPA levels in cases and controls were equal. Takeuchi and Tstsumi (2002) and Takeuchi et al. (2004) examined BPA levels in healthy men and women and in women with polycystic ovarian syndrome ( PCOS ). The authors reported BPA levels were correlated with women who were obese, with PCOS, and with several hormone levels but it is unclear whether BPA levels were causal or a result of these conditions or hormones. Yamada et al. (2002) reported lower BPA concentrations in the serum of women carrying normal fetuses than that in those carrying fetuses with chromosomal abnormalities, but levels in the amniotic fluid from karyotypically normal and abnormal fetuses were not statistically different. Yang et al. (2006) reported no association between BPA exposure and endocrine-related symptoms, chromosomal abnormalities, or reproductive parameters. 536 v DRI Annual Meeting v October 2010

9 Taken together, the human studies conducted thus far do not support or refute the hypothesis that BPA exposure leads to adverse reproductive or developmental health effects in humans. In one occupational cohort study, current workers from BPA-exposed and control factories were recruited. The workers were exposed to very high BPA levels in their workplace. It was reported that exposed workers had consistently higher risk of male sexual dysfunction across all domains of male sexual function than the unexposed workers. The findings, while all self-reported, provide the first evidence that exposure to BPA in the workplace could have an adverse effect on male sexual dysfunction. (Li et al., 2009) III. Governmental Regulation and Positions Several governmental bodies have undertaken reviews in response to claims of low-dose BPA toxicity (e.g., mg/kg/day). Humans are exposed to much lower levels of BPA, around ug/kg/ day in adults (based on urine biomonitoring). Thus far, no review has concluded that adverse effects that are reported to occur below the traditionally defined no-effect level are sufficiently plausible to constitute a health threat. Regulatory studies using standardized toxicity measures for global regulation thus far have supported the safety of current low levels of human exposure to BPA. Regulatory reviews have been conducted by: European Commission Joint Research Centre ( ECJRC ), the European Scientific Committee on Food ( SCF ), the European Food Safety Authority ( EFSA ), the European Union Scientific Committee on Toxicity, Ecotoxicity and the Environment ( CSTEE ), the Japanese Ministry of Economy, Trade, and Industry ( METI ), the Japanese Ministry of Environment, the U.S. Food and Drug Administration ( U.S. FDA ), Health Canada, the U.S. NTP, and NTP s Center for the Evaluation of Risks to Human Reproduction ( CERHR ). In addition, the U.S. FDA and Australia-New Zealand, Canada, and Europe have all confirmed BPA s use to make protective linings for metal-based food and beverage cans is safe. Even though the regulators have concluded BPA may be safe for low-level usage, many of these agencies are currently still reviewing additional studies and conducting independent studies of the potential health effects of BPA. In a press release on July 9, 2010, EFSA stated that its panel of scientists is reviewing more than 800 publications about BPA. To date, EFSA stated that it would maintain the Tolerable Daily Intake ( TDI ) at 0.05 mg/kg bw per day. After considering the Stump study (Stump et al., 2010), which led Denmark to ban BPA in materials for food for children from birth to three years-of-age, the panel concluded that the study does not provide enough evidence to change its TDI recommendation. A. The U.S. NTP In April 2008, NTP issued a draft brief on BPA, in which it stated: The NTP concurs with the conclusion of the CERHR Expert Panel on Bisphenol A that there is some concern for neural and behavioral effects in fetuses, infants, and children in current at current human exposures. The NTP also has some concern for Bisphenol A exposure in these populations based on effects in the prostate gland, mammary gland, and an earlier age for puberty in females. (NTP, 2008) NTP had negligible concern that exposure of pregnant women to BPA would result in fetal/ neonatal mortality, birth defects, reduced birth weight or growth of offspring, or that BPA would cause reproductive effects in nonoccupationally exposed adults. NTP also had minimal concern for reproduc- Bottles, Cans, and Bans The Latest Dispatch from the BPA Battlefields v Coughlin v 537

10 tive effects in workers exposed to higher levels in occupational settings. (NTP 2008 Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A). B. U.S. EPA Currently, the Environmental Protection Agency is considering initiating rulemaking under the Toxic Substances Control Act ( TSCA ) to add BPA to its chemical concern list and to develop data to further study the environmental effects of BPA. March 2010 EPA action plan: add BPA to chemical concern list require information on concentrations in surface water, ground water, and drinking water require manufacturers to provide test data research ways to reduce exposures, including identification of substitutes further evaluate the potential disproportionate impact on children or other subpopulations C. U.S. FDA In January 2010, the FDA said, studies have supported the safety of BPA. However recent studies using novel approaches have (raised) some concerns. Therefore, FDA is carrying out studies to clarify uncertainties. In its Draft Assessment of BPA, the FDA reported that it believed 5 mg/kg/day level exposure was safe and, in its updated materials, the FDA vowed to continue its evaluation of BPA through its National Center for Toxicological Research with studies that include: physiological based pharmacokinetic modeling with rodents and nonhuman primates rodent subchronic in dose-response relationship in the prostate and mammary glands for oral administration of BPA, including potential metabolic changes and cardiovascular endpoints, using an in utero phase, mimic bottle feeding, and various dose ranges rodent behavioral/neuroanatomical pilot studies for dose levels related to behavioral, neuroanatomical, neurochemical, and hormonal endpoints Comments to FDA s Assessment and Position: We urge the FDA to ban all BPA in food and beverage containers. American Nurses Association. Current levels of exposure to BPA are not safe and BPA should not be allowed for use in food packaging. Natural Resources Defense Council The FDA should not allow BPA to be used as a food contact substance or food additive as its safety has not been demonstrated. Consumers Union Given the body of literature indicating health risks, the numerous unanswered question, we strongly urge FDA to abandon [the] 5 mg/kg/day dose of BPA [limit], which cannot assure safety for humans. Breast Cancer Action and Fund, Community Access National Network, Consumer Federal of America, Government Accountability Project, National Consumers League, 538 v DRI Annual Meeting v October 2010

11 National Research Center for Women & Families Cancer Prevention and Treatment Fund, and U.S. Public Interest Research Group. We urge the Agency to stop relying on discredited, industry-funded studies, discard the proposed no effect level of 5 mg/kg-day, adopt a protective safe exposure limit that comports with the overwhelming weight of scientific evidence, and take immediate action to remove BPA from canned foods, baby formula and baby food. Environmental Working Group IV. Current and Pending Legislation and Banning A. United States More than 20 states, the District of Columbia, and the United States Congress have introduced or enacted legislation banning the use of BPA in certain products. The bans and proposed bans target BPA used in baby bottles, sippy cups, and formula containers as well as BPA used in food containers, including beverage containers and water bottles. In May 2009, Minnesota became the first state to ban BPA in baby bottles and sippy cups. The Minnesota statute, which went into effect on January 1, 2010, prohibits manufacturers and wholesalers from selling any product, containing BPA, that can be filled with food or liquid and is intended for use by children under three years of age. By January 1, 2011, the law will prohibit retailers from selling any such products, without exception. Given the steps being taken by the U.S. Congress and the legislatures of states including California, Michigan, New York, Oregon, and Washington on BPA, it is clear that additional bans on BPA are on the way. (See attached chart for status of legislation in U.S.). Legislation banning the use of BPA has also been introduced in both the House of Representatives and the Senate as the Ban Poisonous Additives Act of 2009, which is still under consideration. The Act would ban any food container that is composed, in whole or in part, of BPA or any container that can release BPA into food, although under certain circumstances a waiver could be granted for the container as long as a prominent warning of the potential health effects associated with BPA is displayed on the container s label. On April 15, 2010, the Safe Chemicals Act of 2010 was introduced in the Senate and the Toxic Chemicals Safety Act of 2010 was introduced in the House of Representatives. Both Acts would amend TSCA to provide the EPA with additional authority to regulate the use of chemicals, including BPA, and would require the chemical industry to submit certain safety testing data to the EPA. In addition, in May 2010, Senator Dianne Feinstein introduced a controversial amendment to ban the use of BPA in food and drink containers in the pending FDA Food Safety Modernization Act (S. 510). The move threatens the success of the Act as the Grocery Manufacturers of America ( GMA ) and the Chamber of Commerce threatened to oppose the bill if it contained Feinstein s proposed language. The American Chemistry Council and other interest groups have also voiced concerns and opposition to the amendment. The biggest concern to outright banning of the use of BPA is that there is currently no safe alternative to the use of BPA epoxy resins in metal can linings. (GMA s president and CEO, Pamela Bailey s letter to Senate leadership) John M. Rost, chairman of the North American Metal Packaging Alliance, which represents the canned food and beverage industry, said BPA has been used safely in metal Bottles, Cans, and Bans The Latest Dispatch from the BPA Battlefields v Coughlin v 539

12 food packaging for decades. They have been deemed safe by regulatory agencies around the world. He also said there hasn t been a case of food-borne illness resulting from a failure of metal packaging since the industry began using BPA in its linings more than 30 years ago. (Layton, Washington Post, Feb. 23, 2010). B. Canada Despite its regulatory research finding that low-level exposures are safe, in 2008, Canada became the first country to ban BPA in baby bottles. We have immediately taken action on bisphenol A because we believe it is our responsibility to ensure families, Canadians and our environment are not exposed to a potentially harmful chemical. (Tony Clement, Canada minister of health, Oct. 2008) (emphasis added). Billed as a precautionary and prudent move, in June 2010, Canada s government proposed a Consumer Product Safety Act that would, among other things, add polycarbonate baby bottles that contain BPA to the schedule of prohibited products. Although our science tells us that exposure levels to newborns and infants are below the level that cause effects, we believe that the current safety margin needs to be higher. We have concluded that it is better to be safe than sorry, Clement said. C. France Also in June 2010, the French National Assembly passed a law to ban BPA in baby bottles but rejected an amendment that would have prohibited its use in all food-related plastic containers. The law bans the manufacture, importation, exportation, and marketing of baby bottles containing BPA until the French food safety agency issues an opinion approving BPA use. D. Denmark In March 2010, the Danish government, together with the Danish People s Party, decided to invoke the principle of precaution and introduce a temporary national ban on BPA in materials in contact with food for children from birth to three years of age (infant feeding bottles, feeding cups, and packaging for baby food). The Danish Minister of Food said: From DTU Food we have received an assessment based on new comprehensive studies of rats. Danish experts say there is no clear evidence that bisphenol A has harmful effects on the behaviour observed. However, the experts find that the new studies raise uncertainties about whether even small amounts of bisphenol A have an impact on the learning capacity of new-born rats. In my opinion these uncertainties must benefit the consumers, so we will utilize the precautionary principle to introduce a national ban. V. Litigation After the NTP draft report was issued in early 2008, plaintiffs attorneys nationwide began filing numerous consumer class action complaints, alleging breach of express and implied warranties allegedly accompanying BPA-containing products, negligent and intentional misrepresentation, unjust enrichment, and violations of various state consumer protection laws. The target defendants were manufactures of products used by infants (such as baby bottles and sippy cups), manufacturers of baby formula, and retail outlets that sold these products. So far, there has been limited litigation in state courts, but the lawsuits filed in or removed to federal court have been numerous enough to be consolidated in MDL s. 540 v DRI Annual Meeting v October 2010

13 In May 2010, in a consumer class action MDL against manufacturers of baby bottles, sippy cups, baby formula, and retailers, the U.S. District Court for the Western District of Missouri ordered discovery into defendants knowledge of BPA health effects and communications with consumers about the presence or absence of BPA. (In Re: Bisphenol-A (BPA) Polycarbonate Plastic Products Liability Litigation, MDL No. 1967). A second BPA MDL has been consolidated in the Western District of Kentucky involving suits against an aluminum bottle manufacturer that claimed its products were BPA-free when they were lined with BPA-containing resins. (In Re: Sigg Switzerland (USA), Inc., Aluminum Bottles Marketing and Sales Practices Litigation, MDL No. 2137). Manufacturers and retailers have company as targets of litigation. After the NRDC gave the FDA 90 days to its request that the FDA drop the acceptable level of BPA lower than 5 mg/kg/day, the NRDC filed a lawsuit against FDA for not acting on its petition. ( hea_ a.pdf). The litigation promises to expand in other ways. Industries other than the baby product industry that are involved in the production and distribution of BPA-containing products that come into contact with humans are likely future targets, particularly those that manufacture or supply food containers or their components. Furthermore, the types of claims are likely to expand. Plaintiffs have not yet, but likely will, assert claims for personal injury as a result of exposure to BPA. Until that time, manufacturers of BPA and BPA-containing products may face claims for medical monitoring. Many states recognize a cause of action for medical monitoring, through which consumers can require manufacturers to establish a fund to pay for future medical tests and surveillance that consumers claim are necessary due to their or their children s alleged exposure to a product. Like consumer class actions, medical monitoring claims in some states do not require a plaintiff to have sustained a physical injury. In addition, medical monitoring claims often are filed as class actions, increasing the complexity and scope of discovery and case management strategies. Despite the science, the controversy regarding BPA is not going away. The furor of the press and nongovernmental organizations over a chemical with a clean record may well be a warning of things to come. Bottles, Cans, and Bans The Latest Dispatch from the BPA Battlefields v Coughlin v 541

14 Attachment Status of Federal and State BPA Legislation (updated 7/8/10) STATE Federal STATUS House Bill 1523 and Senate Bills: S.593 and S. 753 (i.e. BPA-Free Kids Act) Status: The bills are under consideration. Summary: The bills ban BPA from baby bottles, sports water bottles and reusable containers. The bills would also ban BPA from canned foods where safe alternatives exist and require labeling where they don t, and would give the FDA authority to modernize its process for reviewing food packaging additives like BPA. Effective Date: 180 days after enactment. District of Columbia Council Bill 521 Status: The bill was introduced on January 16, 2009 and is currently pending approval in the House Committee on Government Operations and the Environment. Summary: The bill prohibits the manufacture, sale, offer for sale, or distribution in commerce of any product intended for use by children under the age of 6 that contains BPA. Effective Date: 180 days after the effective date of this act. California SB 797 Toxics-Free Babies and Toddlers Act Status: The bill was introduced in early 2009; passed July 1, 2010 by Assembly and moves back to Senate for approval or amendment. Summary: Prohibits the manufacture, sale or distribution of any bottle or cup that contains BPA, at a level above 0.1 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 3 years of age or younger. Applies to manufacture, sale or distribution on or after January 1, Connecticut House Bill: 6572; Public Act No Status: Enacted June 3, 2009 Summary: The bill bans the manufacture, sale, and offer to sell or distribute of any infant formula or baby food that is stored in a plastic container, jar or can that contains BPA. However, a person may sell or distribute his or her existing 542 v DRI Annual Meeting v October 2010

15 STATE STATUS inventory of infant formula or baby food, containers, jars or cans containing BPA from October 1, 2011 until October 1, 2012 provided the person can demonstrate that such containers, jars or cans were purchased or acquired prior to October 1, 2011, in a quantity comparable to the containers, jars or cans purchased or acquired during the same period of the prior year. Effective Date: October 1, 2011 Delaware Assembly/Senate Bill: None Status: While Delaware has not introduced any form of BPA legislation, six companies: Playtex Products, Gerber, Evenflow, Avent America, Dr. Brown s and Disney First Years; said they would stop the sale of plastic polycarbonate baby bottles in the U.S. This is in response to action by Connecticut attorney general Richard Blumenthal, and the attorney generals in Delaware and New Jersey. Summary: N/A Effective Date: N/A Hawaii House Bill 1633 Status: The bill is pending approval in the House Committee on Judiciary. The bill provides that the legislative reference bureau shall perform a study, working with information from the Centers for Disease Control, investigating the risks involved in the use of BPA in consumer products, including children s toys and childcare products. The legislative reference bureau will then submit its findings, including any suggested legislation to the legislature no later than 20 days prior to the convening of the 2010 Regular Session. Summary: The bill, as introduced, prohibits the manufacture, sale, or distribution of any toy or child care article that is intended for use by a child under 3 years of age and contains BPA. The bill requires that manufacturers use the least toxic alternative when replacing BPA and phthalates in accordance with this part. Manufacturers cannot replace BPA with carcinogens rated as A, B, or C by the United States Environmental Protection Agency s list of chemicals evaluated for carcinogenic potential; or reproductive toxicants that cause birth defects, reproductive harm, or developmental harm as identified by the United States EPA. Effective Date: January 1, 2050 Illinois Illinois House Bill 2845 Current as of 5/6/ Bottles, Cans, and Bans The Latest Dispatch from the BPA Battlefields v Coughlin v 543

16 STATE STATUS Status: Pulled from consideration (advocates did not have the votes to pass it). Summary: Bill would have banned the use of BPA in plastic containers (e.g. baby bottles, etc.) if designed primarily for use by children younger than 3, and bans BPA use in all sports bottles. Effective Date: proposed July 1, Note: The City of Chicago passed a law (Municipal Ordinance ) banning the sale, after 2010, of any empty food or drink container containing BPA that is intended for use by children younger than 3 years old. Maryland 2009 Maryland House Bill 15; Senate Bill 213 Status: Signed into law July 1, Summary: Prohibits the manufacture, sale, or distribution of bottles or cups for children under 4 years old that contain Bisphenol-A. Companies must use a least-toxic alternative when manufacturing such products. Effective Date: January 1, Massachusetts H.B Status: Under consideration (by Joint Committee on Public Health). Summary: Bill directs the Massachusetts Department of Public Health to classify BPA as a hazardous substance when contained in products manufactured, sold, or distributed in Massachusetts. Effective Date: January 1, 2010 Note: On August 4, 2009, the Massachusetts Dept. of Public Health issued a warning instructing parents to keep children away from products containing BPA. Senate Bill 432 Status: Under consideration (by Joint Committee on Environment, Natural Resources, and Agriculture). Summary: Prohibits the manufacture, sale, or distribution of any toy or childcare article intended for use by a child under 3 that contains BPA. Manufacturers must use the least-toxic alternative. Current as of 5/6/ v DRI Annual Meeting v October 2010

17 STATE STATUS Effective Date: January 1, 2010 Michigan House Bill 4522 Status: Under consideration (by the House Committee on the Great Lakes & the Environment). Summary: Prohibits manufacture and sale of any product designed for use in children 7 or younger that contains a detectable amount of BPA. Effective Date: Not listed Minnesota Senate Bill 247, House Bill 326 Montana House Bill 454 Status: Passed and signed by Governor Summary: Prohibits manufacturer or wholesaler from selling any product, containing BPA, that can be filled with food or liquid and is intended for use by children under 3 (exemption for used children s products). The law also prohibits retailers from selling any such products, without exception. Effective Date: Manufacturers and wholesalers: January 1, 2010; Retailers: January 1, Status: Bill failed to pass. Summary: Would have banned the manufacture, sale, and distribution of any (1) container that contains BPA if that container is designed to contain liquid/food for use primarily by children 3 or younger, (2) container containing BPA at greater than 0.5 parts per billion, and (3) sports water bottle containing BPA. Effective Date: July 1, 2010 New Jersey Assembly Bill 2112, Senate Bill 1804 Status: Under consideration Summary: Bans sale or distribution of food or beverage packages/containers made or composed with BPA. Effective Date: January 1, 2010 Current as of 5/6/ Bottles, Cans, and Bans The Latest Dispatch from the BPA Battlefields v Coughlin v 545

18 STATE STATUS New York Assembly Bill 6919 Status: Passed the state Assembly, and passed the state Senate on June 24, 2010; sent to Governor Paterson for signature. Summary: Bans manufacture, sale, or distribution of any toy or child care product containing BPA intended for use by a child under 14. Effective Date: Baby bottles and cups (December 1, 2010), toys (December 1, 2011), and other food/beverage containers (December 1, 2012). Note: Suffolk (2009), Albany (2009), and Schenectady (2010) Counties have banned beverage containers containing BPA for use by children under 3 years old. North Carolina H.B. 945 ( The Studies Act of 2009 ) Status: Enacted September 10, 2009 Oregon H.B Summary: This Act provides for studies by the Commission, Statutory Oversight Committees and Commissions, and Other Agencies, Committees, and Commissions for several purposes. As to BPA, Part VI (Environmental Review Commission Studies), Section 6.11 allows the Commission to study ways to phase out Polybrominated Diphenyl Ethers (PBDEs) and BPA in flame-retardant products. Status: Pending Summary: A person may not willfully or knowingly manufacture, distribute, sell or offer for sale in the state any liquid or food in a commercially available container made or lined with BPA if the liquid or food is intended primarily for consumption by a child under 3. A person may not willfully or knowingly manufacture, distribute, sell or offer for sale in the state any commercially available container made or lined with BPA if the liquid or food is intended primarily for consumption by a child under 3. S.B Current as of 5/6/ v DRI Annual Meeting v October 2010

19 STATE STATUS Status: Following a vote of 15 for and 15 against, this bill did not pass the Senate. (February 16, 2010) Pennsylvania H.B. 221 Summary: A person may not willfully or knowingly manufacture, distribute, sell or offer for sale in the state any commercially available child s beverage container (defined as an empty baby bottle or cup designed to be filled with liquid intended primarily to be used by a child who is under three years of age) made with BPA. A person who manufactures any child s beverage container made with BPA shall make a reasonable effort to notify any person who distributes, sells or offers for sale the manufacturer s containers made with BPA at least 90 days before the law goes into effect (July 1, 2011). Provides for the recall of products containing BPA. Status: Referred to Consumer Affairs Summary: Amends Unfair Trade Practices and Consumer Protection Law act to prohibit the manufacture, sale or distribution of any bottle, cup or other container that contains BPA at a level above 0.1 ppb if the container is designed or intended to be filled with any liquid, food or beverage primarily for consumption from that container by infants or children three years of age or younger. Does not apply to any liquid, food or beverage in a can or jar that contains BPA. When replacing BPA, manufacturers shall use the least toxic alternative and shall not replace BPA with carcinogens rated by the EPA as A, B, or C carcinogens or substances listed as known or likely carcinogens, known to be human carcinogens, likely to be human carcinogens or suggestive of being human carcinogens, as described in the List of Chemicals Evaluated for Carcinogenic Potential. Manufacturers shall not replace BPA with reproductive toxicants that cause birth defects, reproductive harm or developmental harm, as identified by the EPA. H.R. 94 Rhode Island H 5038 Status: Adopted April 28, 2009 Summary: A resolution urging the Congress of the United State and the Food and Drug Administration to encourage the use of reduced BPA in the manufacture of plastic food containers and bottles and to eliminate the importation, sale and advertising of polycarbonate baby bottles. Current as of 5/6/ Bottles, Cans, and Bans The Latest Dispatch from the BPA Battlefields v Coughlin v 547

20 STATE STATUS Status: Referred to House Health, Education Welfare on April 2, 2009 Committee recommends measure to beheld for further study. Texas H.B Summary: On or after January 1, 2010, a person may not manufacture, sell, or distribute in commerce any toy of child care article intended for use by a child under the age of 6 years and containing BPA. In complying with this subsection, a person shall use the least toxic alternative when replacing BPA and phthalates and may not replace BPA or phthalates with (1) carcinogens rated by the United States EPA as group A, B, or C carcinogens or (2) reproductive toxicants that cause birth defects, reproductive harm, or development harm as identified by the United States EPA. Any person that violates any provision of this section is guilty of a misdemeanor, and upon conviction shall be subject to fine not exceeding $10,000 for each violation. Status: The bill was introduced on February 2, 2009 and referred to Public Health Committee for approval on March 3, Summary: The bill bans the manufacture and sale of cosmetics, jewelry, toys, or any product used for sucking, teething, feeding or facilitating sleep for children under the age of 3 containing BPA. Effective Date: The intended effective date was September 1, However, the legislation has not been enacted. Vermont S. 76 (introduced 2/9/09); H 373 (introduced 3/4/09) Status: Referred to the Committee on Natural Resources and Energy. Summary: Beginning July 1, 2009, no person or entity shall manufacture, sell, or distribute in commerce any food or beverage container, child care article, or toy containing BPA in any concentration. Manufacturers shall use the least toxic alternative when replacing BPA. Manufacturers shall not replace BPA with carcinogens rated by the U.S. EPA as A, B, or C carcinogens or substances listed on the EPA s List of Chemicals Evaluated for Carcinogenic Potential as known or likely carcinogens, known to be human carcinogens, likely to be human carcinogens, or suggestive of being carcinogens. Manufacturers shall not replace BPA with reproductive toxicants that the EPA has identified as causing birth defects, reproductive harm, or developmental harm. A violation of this section shall be deemed a violation of the Consumer Fraud Act. S. 247 (introduced January 5, 2010) Current as of 5/6/ v DRI Annual Meeting v October 2010

21 STATE STATUS Status: Signed into law May 20, Summary: Beginning July 1, 2012, no person or entity shall manufacture, sell, or distribute in commerce in this state (1) any reusable food or beverage container containing BPA, (2) any infant formula or baby food stored in a plastic container or jar that contains BPA. Beginning July 1, 2014, no person or entity shall manufacture, sell, or distribute in commerce in this state any instant formula or baby food stored in a can that contains BPA. Manufacturers shall use the least toxic alternative when replacing BPA. Manufacturers shall not replace BPA with carcinogens rated by the U.S. EPA as A, B, or C carcinogens or substances listed on the EPA s List of Chemicals Evaluated for Carcinogenic Potential as known or likely carcinogens, known to be human carcinogens, likely to be human carcinogens, or suggestive of being carcinogens. Manufacturers shall not replace BPA with reproductive toxicants that the EPA has identified as causing birth defects, reproductive harm, or developmental harm. A violation of this section shall be deemed a violation of the Consumer Fraud Act. The Department of Health shall identify one or more BPA-free containers, including cans, for use in Vermont s women, infants, and children (WIC) program. Washington H.B / SB 6248 Status: Signed into law March 19, Summary: Beginning July 1, 2011, no manufacturer, wholesaler, or retailer may manufacture, knowingly sell, offer for sale, distribute for sale, or distribute for use any bottle, cup, or other container, except a metal can, that contains BPA if that container is designed or intended to be filled with any liquid, food, or beverage primarily for the consumption from that container by children three years of age or younger and is sold or distributed without containing any liquid, food, or beverage. A manufacturer of products that are restricted under this chapter must notify persons that sell the manufacturer s products in Washington about the provisions of this chapter no less than 90 days prior to the effective date of the restrictions. A manufacturer of these products shall recall the product and reimburse the retailer or any other purchaser for the product. A manufacturer, wholesaler, or retailer that knowingly violates this chapter is subject to civil penalty not to exceed $5,000 for each violation in the case of a first offense. In the case of repeat violators, civil penalty may not exceed $10,000 for each repeat offense. Current as of 5/6/ Bottles, Cans, and Bans The Latest Dispatch from the BPA Battlefields v Coughlin v 549

22 STATE STATUS Retailers who unknowingly sell products that are restricted from sale under this chapter are not subject to the civil penalties under this chapter. Wisconsin A.B. 405 / S.B. 271 Status: Approved by Senate on January 26, Effective 90 days after publication, if passed. Summary: No person may manufacture or sell, or offer for sale, at wholesale in this state a child s container (defined as an empty baby bottle or spill-proof cup primarily intended by the manufacturer for use by a child 5 years of age or younger) that contains BPA. A manufacturer or wholesaler who sells or offers for sale in this state a child s container shall ensure the container is clearly labeled as not containing BPA. The department may commence an action in the name of the state to restrain by temporary or permanent injunction a violation of this section. The department or district attorney may commence an action in the name of the state to recover a forfeiture to the state of not less than $100 nor more than $10,000 for each violation of this section. Any person who violates this section maybe fined not more than $5,000, imprisoned for not more than one year in the county jail, or both. Each child s container manufactured, sold, or offered for sale in violation of this section constitutes a separate violation. The department may order a manufacturer or seller of a child s container in violation of this section to recall the container or to repair any defects in a container that has been sold. This section does not apply to the sale of a used child s container. If the court imposes a fine for a violation of this section, the court shall impose a BPA surcharge equal to 50% of the amount of the fine. Current as of 5/6/ v DRI Annual Meeting v October 2010