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To: EFSA
Re: Potential adverse health effects associated with BPA exposures

Prof. Klaus-Dieter Jany Chair of the CEF Panel European Food Safety Authority Largo N. Palli 5/A 43121 Parma, Italy 23rd June 2010

Dear Prof. Jany,

We are writing to welcome the announcement on the European Food Safety Authority (EFSA) website that the CEF panel will be considering ‘hundreds of studies in its review and analysis of the most recent scientific literature’ in its review of the TDI of bisphenol-A in food contact products.

Over the last decade and a half, a substantive body amounting to several hundred peer reviewed scientific papers, have been published that have highlighted potential adverse health effects associated with BPA exposures, at internal doses relevant to levels of biologically active BPA found in humans.

As a March 2010 Review (Vandenberg et al) of 80 bio-monitoring studies of BPA in Environmental Health Perspectives makes clear; ‘The two toxicokinetic studies performed to date, which suggest that human exposure is negligible, have significant flaws and are therefore not reliable for risk assessment purposes.’

However, in its prior risk assessments of BPA, EFSA only relied on a small number of studies rather than the much larger number that the United States Food and Drug Administration recently recognised as valid and of high utility in its risk assessment of BPA, and which led the FDA to express concern about the health hazards posed by BPA.

Only a tiny minority of studies have articulated that BPA exposure is completely safe, and many of these research papers have been criticised in academic commentaries and responses as having serious flaws, but it is these few flawed studies that EFSA previously relied on to declare BPA safe.

For example, a letter co-authored by 24 scientists published in the February 2010 edition of Toxicological Sciences states; ‘Publishing studies that conclude no harm in response to low doses of endocrine disrupting chemicals, when the studies did not include a positive control (Tyl et al., 2002), included inappropriate doses of positive controls (Ryan et al., 2009; Tyl et al., 2008), or included positive controls that showed no effect (Cagen et al., 1999), is inappropriate in peer-reviewed journals (Myers et al., 2009a,b; vom Saal and Welshons, 2006). Such studies violate basic principles of study design.’

Many scientific studies are now calling into question the safety of BPA. For example, a recent study has highlighted that BPA may contribute to metabolic disorders relevant to glucose homeostasis, and suggests that BPA may be a risk factor for diabetes (Alonso-Magdalena et al., 2010). Moreover, experiments at Yale university report that BPA may induce altered developmental programming (Bromer et al.,2010), and Doherty et al (2010) of Yale university have published a study which raises the concern about epigenetic effects of BPA on the regulation of the mammary gland, with potential implications for breast cancer risk. Endometriosis is also a concern as work by Signorile et al (2010) highlights that pre-natal exposure of mice to bisphenol-A causes an endometriosis-like response in female offspring.

It is therefore our opinion that any objective and comprehensive review of the scientific literature will lead to the conclusion that action is necessary to reduce the levels of BPA exposure, particularly in groups at highest risk, namely young infants and pregnant mothers. There are an increasing number of countries that are either already committed to this course of action, or have signalled that they will soon be undertaking similar measures.

We share the concerns of these Governments and regulators and believe that reducing BPA exposure to these groups is both scientifically sound and in the best interest of public health.

As such, we call on you as the Chair of the CEF panel and the CEF Committee Members in their ongoing review to include all relevant studies, including bio-monitoring studies, and based on that evidence we conclude that there is a strong scientific mandate for action.

Yours sincerely,

_Benson Akingbemi, Associate Professor, Department of Anatomy, Physiology and Pharmacology, Auburn University, Auburn, USA. _Prof. Dr. Ibrahim Chahoud, Institute of Clinical Pharmacology and Toxicology, Dept. of Toxicology, Charité - Universitätsmedizin Berlin _André Cicolella, Dipl Eng chemist-toxicologist. _Prof. Patricia Hunt, Meyer Distinguished Professor, School of Molecular Biosciences, Washington State University _Prof. Maricel V. Maffini. Ph.D. Research Assistant Professor. Department of Anatomy and Cellular Biology, Tufts University School of Medicine _Jane Muncke, Ph.D, Environmental Toxicologist, Emhart Glass SA, Switzerland. _John Peterson Myers, Ph.D., Chief Scientist, Environmental Health Sciences, Charlottesville VA. _Angel Nadal, PhD, Professor of Physiology, Instituto de Bioingeniería and CIBERDEM, Universidad Miguel Hernández de Elche, Spain. _Dr John Newby, Medical Information Scientist for the Cancer Prevention Society and Former Member of the Developmental Toxico-Pathology Research Group, Department of Human Anatomy & Cell Biology, Faculty of Medicine, University of Liverpool. _Prof. Jörg Oehlmann, Goethe University Frankfurt am Main, Institute for Ecology, Evolution and Diversity. _Prof. Nicolas Olea, MD, University of Granada, University hospital. _Prof. Gail S. Prins, PhD, Professor of Physiology, Department of Urology, University of Illinois at Chicago. _Prof. Fredrick vom Saal, Curators Professor of Biological Sciences, University of Missouri-Columbia. _Prof. Pietro Giulio Signorile, President of the Italian Endometriosis Foundation. _Prof. Carlos Sonnenschein, MD, Department of Anatomy and Cellular Biology, Tufts University, School of Medicine. _Prof. Ana M Soto, MD, Department of Anatomy and Cell Biology, Tufts University, School of Medicine. _Prof. Hugh S. Taylor, M.D., Professor of Molecular, Cellular and Developmental Biology, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University. _Laura N. Vandenberg, PhD, Postdoctoral Fellow, Center for Regenerative and Developmental Biology, Tufts University. _Prof. Cheryl S. Watson, PhD, Professor, Biochemistry & Molecular Biology Dept. University of Texas, Medical Branch, Galveston. _Prof. Andrew Watterson, Occupational and Environmental Health Research Group, University of Stirling. _Prof. R. Thomas Zoeller, Biology Department, Morrill Science Center, University of Massachusetts.   _Action for Breast Cancer, Malta _Alliance for Cancer Prevention, UK _Arnika, Czech Republic _Association for Environmental and Chronic Toxic Injury, Italy _Austrian section of ISDE (International Society of Doctors for the Environment), Austria _Breast Cancer Fund, USA _Breast Cancer UK, UK _BUND / Friends of the Earth Germany, Germany _Cancer Prevention and Education Society, UK _ChemSec –International Chemical Secretariat, International _CHEM Trust, UK _Chemical Sensitivity Network, Germany _Clean Air Action Group, Hungary _Comité pour le Développement Durable en Santé, France _Danish Consumer Council, Denmark _The Danish Ecological Council, Denmark _Eco-Accord Program on Chemical Safety, Eastern Europe, Caucasus and Central Asia _EcoAid, Germany _Ecologistas en Acción, Spain _Environmental Health Fund, USA _Environment Illinois, USA _European Environmental Bureau, EU _Finnish Association for Nature Conservation, Finland _Friends of the Earth Spain, Spain _Global 2000 / Friends of the Earth Austria, Austria _Health and Environmental Network, Europe _Health Care Without Harm, International _Indiana Toxics Action, USA _Instituto Sindical de Trabajo Ambiente y Salud, Spain _The Irish Doctors’ Environmental Association, Ireland _Italian Endometriosis Foundation, Italy _Plastic Planet, Austria _Rachel’s Friends Breast Cancer Coalition, USA _Réseau Environnement Santé, France _Society for Sustainable Living, Czech Republic _Unison, UK _VHUE e.V., Germany _Women in Europe for a Common Future, Europe _Women’s Environmental Network, Scotland _Women’s Voices for the Earth, USA _WWF European Policy Office, Europe

References _Vandenberg LN, Chauhoud I, Heindel JJ, Padmanabhan V, Paumgartten FJ, Schoenfelder G 2010. Urinary, Circulating and Tissue Biomonitoring Studies Indicate Widespread Exposure to Bisphenol A. Environ Health Perspect :-. doi:10.1289/ehp.0901716 http://ehp03.niehs.nih.gov/article/... _vom Saal FS, Akingbemi BT, Belcher SM, Crain DA, Crews D, Guidice LC, Hunt PA, Leranth C, Myers JP, Nadal A, Olea N, Padmanabhana V, Rosenfeld CS, Schneyer A, Schoenfelder G, Sonnenschein C, Soto AM, Stahlhut RW, Swan SH, Vandenberg LN, Wang H, Watson CS, Welshons WV and Zoeller RT. 2010. Flawed Experimental Design Reveals the Need for Guidelines Requiring Appropriate Positive Controls in Endocrine Disruption Research. Toxicological Sciences 2010 115(2):612-613; doi:10.1093/toxsci/kfq048 http://toxsci.oxfordjournals.org/cg... _Alonso-Magdalena P, Vieira E, Soriano S, Menes L, Burks D, Quesada I, et al. 2010. Bisphenol-A Exposure during Pregnancy Disrupts Glucose Homeostasis in Mothers and Adult Male Offspring. Environ Health Perspect :-. doi:10.1289/ehp.1001993 http://ehp03.niehs.nih.gov/article/... _Bromer JG, Zhou Y, Taylor MB, Doherty L, Taylor HS. Bisphenol-A exposure in utero leads to epigenetic alterations in the developmental programming of uterine estrogen response. FASEB J. 2010 Feb 24. [Epub ahead of print] PubMed PMID: 20181937. _Doherty L, Bromer JG, Zhou Y, Aldad TS and Taylor HS. In Utero Exposure to Diethylstilbestrol (DES) or Bisphenol-A (BPA) Increases EZH2 Expression in the Mammary Gland: An Epigenetic Mechanism Linking Endocrine Disruptors to Breast Cancer. Hormones and Cancer. DOI: 10.1007/s12672-010-0015-9. http://www.springerlink.com/content... _Signorile PG, Spugnini EP, Mita L, Mellone P, D’Avino A, Bianco M, Diano N, Caputo L, Rea F, Viceconte R, Portaccio M, Viggiano E, Citro G, Pierantoni R, Sica V, Vincenzi B, Damiano G. Mita DG, Baldi F and Baldi A. Pre-natal exposure of mice to bisphenol A elicits an endometriosis-like phenotype in female offspring. General and Comparative Endocrinology. doi:10.1016/j.ygcen.2010.03.030.

Last updated on 14 June 2011

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