Ethinyl Oestradiol: bitter pill for the precautionary principle

Abstract

Many decades of research have shown that when released to the environment, a group of hormones known as oestrogens, both synthetic and naturally occurring, can have serious impacts on wildlife. This includes the development of intersex characteristics in male fish, which diminishes fertility and fecundity. Although often sublethal, such impacts may be permanent and irreversible. This chapter describes the scientific evidence and regulatory debates concerning one of these oestrogens, ethinyloestradiol (EE2), an active ingredient in the birth control pill. First developed in 1938, it is released to the aquatic environment via wastewater treatment plants. Although it is now clear that wildlife species are exposed to and impacted by a cocktail of endocrine disrupting chemicals, there is also reasonable scientific certainty that EE2 plays a significant role, and at vanishingly low levels in the environment. In 2004 the Environment Agency of England and Wales accepted this, judging the evidence sufficient to warrant consideration of risk management. In 2012, nearly 75 years after its synthesis, the European Commission proposed to regulate EE2 as a EU-wide 'priority substance' under the Water Framework Directive (the primary legislation for protecting and conserving European water bodies). This proposal was subsequently amended, delaying any decision on a regulatory 'environmental quality standard' until at least 2016. This is in part because control of EE2 will come at a significant price. Complying with proposed regulatory limits in the environment means removing very low (part per trillion) levels of EE2 from wastewater effluents at considerable expense. Is this a price we are willing to pay? Or will the price of precautionary action be simply too high — a pill too bitter to swallow? To what extent is society, which has enjoyed decades of flexible fertility and will also ultimately pay for the control and management of its unintended consequences, involved in this decision? And what could this mean for the many thousands of other pharmaceuticals that ubiquitously infiltrate our environment and which could have sublethal effects on aquatic animals at similarly low levels?