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Statement to the Bisphenol A (BPA) Subcommittee of the Science Board to the Food and Drug Administration

Submitted in response to FDA meeting to discuss the draft assessment of BPA for use in food containers; Request for Public Comment FDA-2008-N-0038
September 16, 2008

Hello.  My name is Dr. Beth Jordan.  I am an internist, formerly of the Mayo Clinic, and I currently serve as the medical director of the Association of Reproductive Health Professionals (ARHP).

For nearly 50 years, ARHP has established itself as the leading source for trusted medical education and information on reproductive and sexual health. ARHP educates health care providers, informs consumers, and impacts public policy. Through convening teams of organizational colleagues and respected experts, ARHP advocates for reproductive health advances and educates professionals across specialties. ARHP is well-positioned as the leader in providing credible, evidence-based programs on all that is current and urgent in reproductive health. Our membership is composed of 11,000 member professionals who provide reproductive health services or education, conduct reproductive research, or influence reproductive health policy.

Thank you for the opportunity to speak to you today on the topic of Bisphenol A (BPA) use in food containers.

We come before the BPA Subcommittee today to urge you to do two things as you consider the draft assessment of BPA for use in food contact applications:

  1. Use all existing research on health effects of BPA to make a final determination about whether or not it is safe
  2. Let any action the FDA takes with regard to BPA be driven by the precautionary principle

The FDAs current draft assessment concludes that BPA is safe for use in food containers.  According to the draft, this conclusion is based on two studies both of which are funded by institutions that have a financial stake in the outcome of the FDAs decision. 

While the science is still emerging, whats presently known about BPA is worrisome.  Human exposure to BPA, an endocrine disrupting chemical compound used to create countless consumer products, is widespread.  Emerging research reveals that low-levels of BPA that were previously thought not to be harmful may now be associated with negative health outcomes. For example, this research indicates that BPA may be related to increased trends in humans regarding: abnormal penile/urethral development in males and early maturation in females, increased neurobehavioral disorders such as attention deficit hyperactivity and autism, increase childhood and adult obesity and Type 2 Diabetes Mellitus, regional decreases in sperm count, and increased hormonally-mediated cancers such as prostate and breast cancers.

Informed by this research from the environmental sciences, and by confirmatory research in laboratory animals who are exposed to levels of Bisphenol A that are relevant to human exposures, the scientific community is becoming increasingly concerned about BPAs adverse effects upon humans, particularly women of reproductive age, pregnant women, developing embryos, and young children. These concerns are based on a growing body of toxicology assessments demonstrating that low dose exposure levels can not be deemed safe based on high dose studies in the case of BPA.

Two points are chief among ARHPs concerns about the FDAs current draft assessment.

  1. Safety evaluations of chemicals should take into account the entire existing body of research.  To date, over 100 publicly and privately funded studies have been completed or performed on the health effects of BPA exposure.  To make its determination, the FDA used two of the 100+ existing studies both of which followed Good Laboratory Practices, or GLP a set of standards commonly used by industry-based researchers. The FDA should strongly consider using the vast body of research available from non-GLP studies. Many university-based and independent researchers dont use GLP standards because of the high costs associated but are still using research methodology and design considered to be among the best in the world.
  2. The two studies the FDA used to reach its conclusion are among the twenty or so industry funded studies.  Currently, there is a concern expressed among valued scientists that all BPA scientific studies are not created equal.  Of the industry funded studies, none have found BPA to have health effects.  However, over 100 studies have been conducted by independent NIH funded scientists on the effects of BPA exposure and all have found health effects.  This level of disparity among studies, particularly when the sharp contrast exists along funding lines, is alarming.

The FDA should reconsider its current assessment and bring to bear the weight of all existing research on BPA safety to reach its determination.  In doing so, the FDA will ensure that the public benefits from all we currently know about low-dose chronic exposure to BPA.

ARHP supports the use of evidence-based science to inform clinical decision making. Unfortunately we do not always have the data we want to make the best recommendations to our patients. But absence of a certain kind of evidence does not necessarily mean evidence of absence of harm. Ethical concerns prevent us from ever being able to conduct randomized double-blinded placebo controlled studies on pregnant women looking at various effects of various levels of exposure to BPA, or other endocrine disruptors like phthalates, Polybrominated Flame Retardants, Dioxin, Pesticides and perfluorinated compounds. Scientific uncertainty will therefore continue to exist.  For several reasons, even when all the existing research on the health effects of BPA is considered, the FDA may not be able to reach a final conclusion on the safety of BPA exposure to the general public. 

The Precautionary Principle is generally defined as the following: When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically. In this context the proponent of an activity, rather than the public, should bear the burden of proof. The process of applying the precautionary principle must be open, informed and democratic and must include potentially affected parties. It must also involve an examination of the full range of alternatives, including no action.

In the face of scientific uncertainty and credible threats of harm, ARHP supports precautionary action in the form of governmental recommendations to decrease overall BPA exposure.  The absence of scientific certainty should not be used to justify a lack of action to protect public health from possible harm.  In the absence of a consensus, the burden of proof should be on the institutions making claims of safety.  Until proof of safety is established we urge the FDA to take measures to decrease chronic low-dose exposure to BPA in the general public, particularly in pregnant women and infants.

In sum, our two recommendations to the BPA Subcommittee are to:

  1. Use all the existing research to inform the FDAs consideration of BPAs safety; and
  2. Use the precautionary principle in the absence of scientific certainty when taking any action that will affect public health, particularly with regards to BPA exposure to pregnant women and infants.

Thank you for the time to address the committee on this important issue that potentially affects the health and lives of countless women and children.