Bisphenol A & Phthalates

Bisphenol A (BPA) and phthalates are both found in plastics. BPA is a plastic strengthener, while phthalates are plastic softeners. Studies have linked both chemicals with injuries in animals, and have suggested that they also pose risks to humans. Some states have restricted the use of these chemicals, and many others are considering similar restrictions. Although only a few lawsuits have been filed to date, it is possible that we could see a large number of claims involving these chemicals in the future, especially if additional research confirms a causal link between exposure and injury in people.

Background

Bisphenol A (BPA) is a chemical compound used mainly in the production of certain hard plastics. It is found in items including baby bottles, water bottles, liners of food and beverage containers, CDs and DVDs, dental sealants and eyeglasses. BPA helps protect the contents of cans from corrosive metal, and can help extend the shelf life of products. However, when plastics break down due to high heat or use, BPAs can leach out. Phthalates, used to soften plastic, are used in hundreds of products, including IV tubes, bottles, shower curtains, children’s’ toys and cosmetics.

Injuries and Damages

Studies have shown that more than 90% of the test population had detectable levels of BPA in urine samples. According to the Washington Post, more than 100 published studies have identified possible health concerns stemming from BPA. A recent report issued by the National Toxicology Program identified a link between BPA and early puberty, urinary tract problems and other health issues in lab rats. The report states the possibility that BPA “could alter human development,” and could affect neural and behavioral development in fetuses, infants and children. However, the evidence was limited, and the report called for additional research. Other studies have linked BPA to cancers, heart disease and diabetes.

Studies funded by industry groups have not found a link between BPA and adverse health effects. These industry groups argue that studies linking possible health issues with animals should be disregarded; it does not mean that humans will be affected by low-levels of BPA. In December of 2008 the FDA stated that it would continue to recommend that BPA was safe for use unless additional testing and research found otherwise. The Chief of the FDA's Office of Food Additive Safety stated that she did not feel that there was sufficient data to justify banning BPA. Several newspaper investigations contend that the FDA’s conclusion was based in large part on the industry funded studies and was therefore subject to question. Congress has begun investigating whether there has been any undue industry influence in the regulating of BPA.

Many companies that use and manufacture BPA have voluntarily taken steps to remove it from their products. Sunoco, a BPA manufacturer, wants its customers to guarantee that BPA will not be included in food or water containers meant for children under three years old. Six major baby bottle manufacturers have agreed to stop using BPA in bottles as part of an agreement with the attorneys’ general of three states. Toys R Us and Walmart are among the stores that have begun to remove products with BPA from their inventory.

Phthalates have been linked to possible abnormalities in the reproductive tract, thyroid damage, asthma, and early onset of puberty. Studies have also found lower testosterone in males who have higher levels of certain phthalates. Phthalates appears to impact males more than females due to the biological differences in the development sex organs. Some experts contend that phthalates may be responsible for an increase of the hypospadias birth defect, the incomplete development of the male organs. In 2003, The American Academy of Pediatrics that phthalates are a health concern and the more research into its effects was needed. The FDA website states that “it’s not clear what effect, if any, phthalates have on health,” and that “at the present time, FDA does not have compelling evidence that phthalates, as used in cosmetics, pose a safety risk.

Legislation and Regulation

In 2009, bills to ban the use of BPA in all food and beverage containers were introduced in Congress. However, manufacturers who can demonstrate that there was no current alternative to using BPA in a product would be able to obtain a renewable waiver. Suffolk County, in New York, became the first jurisdiction in the U.S. to ban BPA from being used in sippy cups and baby bottles. Almost 20 states are considering legislation restricting BPA in some manner. Canada has banned BPA in baby products. It has added BPA to the list of toxic substances.

Phthalates are banned by most European countries in the manufacturing of toys. California and Washington have passed laws banning certain phthalates from certain toys starting in 2009. Phthalates are also subject to regulation in California under Proposition 65, which prevents in-state businesses in from knowingly and intentionally exposing people to dangerous carcinogens. According to an Arnold and Porter article, there have been a number of Proposition 65 suits filed involving phthalates.

The Consumer Products Safety Improvement Act, enacted by Congress in 2009, imposes stricter safety standards on products, and limits the amount of certain types of phthalates that can be in children’s toys or other products. Companies that manufacture or import these products are required to have their products tested by an independent laboratory and certified. The Consumer Product Safety Commission opposes the ban and believes that children are not at risk of injury. According to their, children would have to put toys containing phthalates in their mouths for extended periods of time every day to put them at even the slightest risk of health problems; further research showed that children only put toys in their mouths for less than two minutes a day.

Liability and Insurance

Liability issues for BPA are similar to those of other chemical risks. Liability issues can include:

• Title IX violations
• Public nuisance
• Negligence

There have not been any insurance cases to date involving phthalates or BPAs. However, we can expect that any cases will involve the same types of coverage issues commonly found in toxic tort claims, including trigger of coverage, number of occurrences, and allocation.

Litigation

In August of 2008 multi-district litigation was created for BPA related suits in the Western District of Missouri. When the motion to create the MDL was filed, there were 14 other actions pending. Additional actions were filed while the motion was pending. Defendants in the litigation include retailers such as Target and Wal-Mart; manufacturers such as Avent and Evenflo; and companies such as CVS Caremark Corp. and Rite Aid.

Nalge Nunc International Corp., the maker of Nalgene plastic sports bottles, has been named a defendant in a class action suit. The plaintiffs accuse the company of violations of California’s Business and Professional Code as well as breach of implied warranties and fraudulent concealment. The complaint alleges that the company was aware of the risks of BPA, but that it continued to assert that it was safe. Nalge has already announced that it plans to utilize BPA free alternatives in its Nalgene Outdoor line of products.

A class action suit was filed in California state court in March of 2008 against five companies who manufacture baby bottles as well as retailers who sell the bottles. The plaintiffs claim that BPA is known to have adverse effects in animals, such as hormonal and neurological problems. The manufacturers named were Gerber Novartis AG, Evenflo Co., Playtex Products Inc., Avent America, Inc. and Dr. Browns. The complaint alleges intentional and negligent misrepresentation and violations of California statutes. The plaintiffs seek injunctive relief preventing the defendants from advertising products that contain BPA without a prominent notice of the presence of the chemical, as well as restitution for the value of all sales during the class period of baby products that contain BPA.

To date there has been very little litigation relating to phthalates. A complaint has been filed against Apple alleging that the iPhone contains phthalates in the headphone cord. Possible defendants in future phthalate litigation could include manufacturers of all products that contain phthalates, such as cosmetics, medical devices, toys, plastics and hospitals.

Future Outlook

It is expected that more lawsuits will be filed against manufacturers alleging that they were aware of the potential dangers of BPAs or phthalates, and failed to warn of the risks or negligently misrepresented the safety of their products. An increasing number of retailers have stated that they will not sell products that contain phthalates or BPA. Whether BPAs and phthalates become a major issue for insurers will depend in large part upon whether further research confirms that these chemicals can pose a danger to humans.

In the News

2017

• ‘BPA-free’ meets ‘fake news’ - Steven Hentges, American Chemistry Matters, American Chemistry Council (03/29/2017)
  Thanks to years of attention to bisphenol A (BPA), used primarily to make polycarbonate plastic and epoxy resins, there is now quite a bit of attention to various alternatives described generically as “BPA-Free“.
• In BPA safety war, a battle over evidence - Warren Cornwall, Science Mag (02/09/2017)
  In the 1930s, a U.K. biochemist made a curious observation that today remains at the center of a raging debate about chemical safety. He noticed that the synthetic chemical bisphenol A (BPA) weakly mimics the human hormone estrogen.
• The BPA debate is back, as workers exposed to levels 70 times the average - Olga Oksman, Guardian (01/22/2017)
  A 2008 ruling by the Federal Drug Administration (FDA) found that low exposure to chemical is safe...However, a new study - the first of its kind in the US - has looked at the exposure levels of people who come into contact with high doses of BPA, and found that employees who directly handle the plasticizing chemical had urine levels of BPA around 70 times greater than that of the average US adult...Currently, the Occupational Safety and Health Association (Osha) does not set any workplace exposure limit for BPA. Without Osha exposure limits for the chemical, manufacturing works who are concerned by their exposure don't have any real recourse when to avoiding the chemical on the job.

2016

• House Approves Bill to Regulate Toxic Chemicals - Matthew Daly, Associated Press through the Fulton Sun (05/24/2016)
  The House on Tuesday easily approved a bipartisan bill that would for the first time regulate tens of thousands of toxic chemicals in everyday products from household cleaners to clothing and furniture.

2013

• Pass it on: The Lasting Danger of Toxic Chemicals - Deidre Imus, FoxNews.com (12/02/2013)
  Well-known chemicals like DEET, bisphenol A (BPA), certain phthalates, nicotine and others have been shown to have similar "transgenerational" effects, meaning health side effects turn up in the great-grandchildren of the initially exposed generation. 

2012

• US won't ban chemical BPA from food packages - Yahoo!News (04/02/2012)
  US regulators on Friday rejected an appeal by environmental groups to ban an industrial chemical known as bisphenol-A, saying there was not enough scientific evidence of harm in humans.

2011

• Court Rejects Bid to Spur U.S. Regulation of BPA - Jeremy Jacobs, New York Times (06/17/2011)
  A federal appeals court today ruled against the Natural Resources Defense Council's effort to force the Food and Drug Administration to limit bisphenol A (BPA) in food additives. The ruling is a blow to NRDC's efforts for stricter regulations on BPA.
• Hitting the Bottle - Dominique Browning, New York Times (05/08/2011)
  Manufacturers might be removing BPA, a chemical used to harden certain plastics, from their products, but they are substituting chemicals that may be just as dangerous, if not more so.

2010

• Canada Declares BPA, a Chemical in Plastics, to Be Toxic - Ian Austin, New York Times (10/13/2010)
  The government of Canada formally declared bisphenol A, a chemical widely used to create clear, hard plastics, as well as food can liners, to be a toxic substance on October 13th. 
• In Feast of Data on BPA Plastic, No Final Answer - Denise Grady, New York Times (09/06/2010)
  The research has been going on for more than 10 years. Studies number in the hundreds. Millions of dollars have been spent. But government health officials still cannot decide whether the chemical bisphenol-A, or BPA, a component of some plastics, is safe.  
• Disputed chemical bisphenol-A found in paper receipts - Lindsey Layton, Washington Post (07/27/2010)
  As lawmakers and health experts wrestle over whether a controversial chemical, bisphenol-A, should be banned from food and beverage containers, a new analysis by an environmental group suggests Americans are being exposed to BPA through another, surprising route: paper receipts.
• New E.P.A. Scrutiny Is Set for a Chemical in Plastics - John M. Broder, New York Times (03/29/2010)
  The Environmental Protection Agency plans to add bisphenol-A, or BPA, a plastic widely used in food packaging and plastic bottles, to its list of chemicals of concern because of potential adverse impacts on the environment and human and animal health. 

Additional Items

• BisphenolA
  This website is a comprehensive resource for environmental, health and safety information about bisphenol A (BPA).
• Phthalate Information Center
  The Phthalate Esters Panel (the Panel) of the American Chemistry Council is composed of all major manufacturers and some users of the primary phthalate esters in commerce in the United States. Panel members include: BASF Corporation, Eastman Chemical Company, ExxonMobil Chemical Company, and Ferro Corporation. Teknor Apex Company, a major user of the materials, is an associate member.
• U.S. Department of Health and Human Services
  Statement by Norris Alderson, Director Office of Science and Health Coordination FDA on the Safety of Bisphenol-A (BPA) and Phthalates.