FDA Continues to Study BPA

Bisphenol A (BPA) is a chemical used in the production of plastics and resins, such as some water bottles and the coatings of some food cans. It is also used in some consumer goods, such as compact discs and thermal cash register tapes. And it has generated controversy about its impact on human health and development.

   The Food and Drug Administration’s assessment is that the scientific evidence at this time does not suggest that the very low levels of human exposure to BPA through the diet are unsafe.
   The agency has performed extensive research on BPA, has reviewed hundreds of other studies, and is continuing to address questions and potential concerns raised by certain studies.
   FDA scientists have also recently determined that exposure to BPA through foods for infants is much less than had been previously believed and that the trace amounts of the chemical that enter the body, whether it’s an adult or a child, are rapidly metabolized and eliminated.
   Dennis M. Keefe, Ph.D., director of FDA’s Office of Food Additive Safety, and other officials at FDA say the agency takes all concerns about BPA seriously and is evaluating them as part of the agency’s ongoing oversight of food safety.
Because of some studies in young animals that raised potential concerns about the safety of BPA, there has been particular concern about its use in infant bottles and training (sippy) cups, FDA has been supporting industry efforts to find alternatives to BPA in the manufacture of these and other products, Keefe says.

Potential Concerns about BPA

BPA has been used since the 1960s to make polycarbonate plastics and epoxy resins. These hard, clear plastics are often used in containers that store food and beverages, such as some water bottles. The resins are also used to protect foods from microbial and other contamination by coating the inside of metal products, such as some food cans.
   Research has shown that people are exposed to BPA because small amounts can migrate into the food and beverages from their containers. Reports from some animal studies have raised potential concerns that BPA exposure may cause multiple health problems, including reproductive disorders, diabetes and cardiovascular disease.
There have also been studies that contend that BPA is a hazard to people too. But FDA—as well as the European Food Safety Agency (EFSA)— has carefully assessed these studies and finds no convincing evidence to support that belief.
   The regulatory agency must objectively weigh all the evidence, says Keefe. “We make public health decisions based on a careful review of well performed studies, not based on claims or beliefs. We have to perform an unbiased evaluation of the data,” he says.
   FDA is continuing its research and monitoring of studies to address uncertainties raised about BPA.

FDA’s Findings

With the support of the National Institute of Environmental Health Sciences (NIEHS) and the National Toxicology Program (NTP), scientists at FDA’s National Center for Toxicological Research (NCTR) have been studying BPA.
The NCTR researchers have been conducting in-depth studies of BPA since September 2008, when a report by the NIEHS and NTP called for more research into the potential toxic effects of BPA on fetuses, infants and children.

NCTR’s findings include:
* The level of BPA from food that could be passed from pregnant mothers to the fetus is so low that it could not be measured. Researchers fed pregnant rodents 100 to 1 000 times more BPA than people are exposed to through food, and could not detect the active form of BPA in the fetus eight hours after the mother’s exposure.
* Exposure to BPA in human infants is from 84 to 92 percent less than previously estimated.
   NCTR researchers report that they were able to build mathematical models of what happens to BPA once it’s in the human body. These models showed that BPA is rapidly metabolized and eliminated through feces and urine. They found that BPA is “exactly the opposite” from some other toxins, like dioxin, that can stay in the body’s tissues for months or even years.
   The center’s toxicology research has not found evidence of BPA toxicity at low doses in rodent studies, including doses that are still above human exposure levels.

Bisphenol A – Indispensable for High-grade Plastic

DVDs, cell phones, protective helmets, cars and solar panels are examples of the many products containing the high-performance plastic polycarbonate. It makes our lives safer, more pleasant and more environmentally friendly. Polycarbonate is based on bisphenol A, or BPA, an important chemical intermediate that has been studied and used safely for more than 50 years.
   Strong, lightweight, highly transparent, plus durable, easy to shape and easy to recycle: polycarbonate combines numerous useful properties that make the material suitable for a wide range of innovative applications. It is an important tool for fuel-saving mobility and sustainable building. Bayer discovered polycarbonate and is currently among the world's largest producers.
Indispensable in the production of this versatile plastic is bisphenol A, which with global annual production of approximately 4.5 million metric tons is one of the world’s most important industrial chemicals. It is also one of the most thoroughly studied chemical substances. BPA has been subjected to intensive study and assessment by government agencies around the world. They have found the substance to be safe for both consumer and commercial use within its intended applications, including food contact.


No equivalent alternatives

There are no equivalent, well-studied and technically feasible alternatives for Bisphenol A. Polycarbonate made with a component other than Bisphenol A would not have the same superior technical properties.
In its intended uses, bisphenol A is not expected to negatively impact the environment, nor does it represent a health risk for humans. Firmly bound in the plastic, only trace amounts of it can migrate. In the slight amounts to which humans can be exposed, it is non-carcinogenic and would not be expected to cause adverse effects on fertility.
     In addition, in all studies recognized by global health authorities, it would not be expected to have a negative impact on the endocrine system as a result of normal food intake. Bisphenol A therefore is not considered to be an endocrine disruptor when used as intended.
   In contrast, some researchers maintain that bisphenol A in very small - but not at greater - quantities results in adverse health effects. This is referred to as the low-dose hypothesis. But it has been rejected by many governments and leading scientists around the world because adverse health effects from BPA are not seen in scientific studies specifically designed by regulatory agencies to evaluate chemicals for adverse health effects in humans.

Proven in over 50 years of use: the widespread material polycarbonate

Polycarbonate is found in cars and houses and cell phones; it decorates our homes and provides for better light. It helps to save energy, enhances safety and makes us more comfortable: the high-performance plastic polycarbonate. Thanks to the combination of many useful properties, it is used virtually everywhere. And even after 50 years of use, there is still no end in sight to the potential applications for this proven material from Bayer MaterialScience.
   Lightweight, hard and highly transparent, plus robust, durable, easy to shape and easy to recycle: all properties that qualify polycarbonate for a wide range of applications. These same properties are also what enable the material to play a role in meeting key challenges of our time, such as sustainable building, better medical care and environmentally compatible mobility.
   Cars weigh less thanks to lightweight components of polycarbonate, reducing fuel consumption and protecting the climate. The plastic can, for example, replace heavier glass parts, enabling weight savings of up to 50 percent. A concept study developed by Bayer MaterialScience for the automotive industry shows just how broad ranging the possible uses are today. The model of a complete rear hatch, including the glazing, turn signals, brake lights and tail lights, was cast in a single step.
   Another domain of polycarbonate is modern lighting technology. For instance, polycarbonate lenses bundle the light of light-emitting diodes. Long used in automotive headlamps, LEDs are now making their way into houses and apartments. One important reason is that they use much less energy and last longer than conventional light bulbs. Polycarbonate sheets also have a role to play in sustainable building. Not only do they enable extraordinary architecture on roofs and facades, they also keep out the heat and help to save energy.
   The material offers numerous advantages over glass in buildings. Polycarbonate lets in just as much light, but offers greater design freedom and – thanks to its high breaking resistance – greater security. The material’s strength and durability are what drives the high demand for it in the IT industry. One current example is the cases of ultrabooks, the particularly small and lightweight computers popular today. Polycarbonate has long been used for optical data media, such as CDs and DVDs.
   The plastic is also commonplace in medical technology, particularly when standard materials are unable to meet the stringent requirements for the products. Polycarbonate’s exceptional strength is used in equipment for needle-free injections, for example.