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The Future of Endocrine Disruption Testing and its Impact on Health and Society

Endocrine disruption has gained increased public attention in recent years. One chemical which has attracted a great deal of attention is bisphenol A (BPA), a component of polycarbonate plastics produced worldwide. It was and still is commonly found in water bottles, baby bottles, the lining of aluminum cans, and other food-storage containers. It has been discovered, however, that BPA is an Endocrine Disrupting Chemical (EDC), and large public outcry has spurned a dramatic decrease in products that use BPA.

The United States Food and Drug Administration (FDA) has no current bans on the use of BPA, although many US States have restricted the use of BPA in children’s bottles and feeding containers. Similarly, BPA is banned in the production of baby bottles in all European Union countries.  Some EU countries have individually placed further restrictions while others have deemed it low-risk. In France, a law being enacted this year suspends ‘the manufacture, import, export and marketing of all food containers’ that contain BPA. In Switzerland, it has been determined that such products have no risk to the consumer, though the government advises using BPA-free baby bottles.

Research into the effects of BPA and how they may vary based on exposure levels remains ongoing, however, studies have indicated that it can exhibit estrogenic properties and impact the endocrine system at multiple pathways. Potential effects of BPA include obesity, impaired neurological development, altered thyroid function, sexual and reproductive changes and heightened risk of certain cancers. Perhaps what is most alarming, however, is that BPA is just a single example of an endocrine disruptor. Many compounds used in consumer-market applications may carry endocrine disruption risk, each with a wide range of potential physiological implications.

Unfortunately, health effects in humans are only part of the problem. Endocrine disruptors may cause serious damage to wildlife and ecosystems, especially aquatic animals and environments. Mutations caused in fish and amphibians are potential outward indicators of far reaching impacts that threaten entire species.

For these reasons, governments and regulatory bodies worldwide are establishing standards for the assessment and permissible use of chemicals that may act as endocrine disruptors.

In a recent article by Trasande et al., (2015) in The Journal of Clinical Endocrinology & Metabolism, it is estimated that diseases and disorders caused by endocrine disruption contribute costs in the hundreds of billions of Euros per year in the EU alone. As the consequences of the presence of EDCs in daily life become more apparent and better understood, screening such substances from development pipelines is becoming increasingly important.

In 2009-2011 CeeTox, now part of Cyprotex, contributed to pre-validation and validation studies for the US Environmental Protection Agency (EPA) which examined recombinant receptors as a means to assess estrogen and androgen binding potential of test substances in vitro. Other in vitro endocrine disruption assays exist and the US EPA Office of Prevention, Pesticides, and Toxic Substances (OPPTS) has used several to help assess endocrine disruption potential of test substances (OPPTS Guideline Series 890. These assays, when utilised together for assessment of potential EDCs, aid in determining if further testing may be required.

The industry is eagerly awaiting a decision from the European Union (EU) on recommendations for testing endocrine disruptors especially in the context of the Plant Protection Products Regulation (EC) 1107/2009 and the Biocidal Products Regulation (EU) 528/2012. The EU Commission has held a number of separate roundtable meetings with stakeholders, member states and MEPs, respectively. A conference on endocrine disruptors, organised by the European Commission, is also due to take place on the 1st June 2015 in Brussels to update on the impact assessment process and to exchange views. Once this process is finalised, we can expect definition of future policy in the European Union with respect to endocrine disruption.