Will EU Regulatory Battles Over Endocrine Disruptors Translate to US Litigation?

Posted by David Schwartz on Posted on

There is a battle raging in the European Union on an issue that is recognized in the US only by environmental scientists, policy wonks, and activists: the regulatory status of endocrine disrupting chemicals. As we have written before, this debate could have dramatic implications for litigation in the US. Such litigation could involve claims that personal care products, food, household cleaners, agricultural chemicals, pharmaceutical products, and occupational exposures are “disrupting the endocrine system” and thereby giving rise to a wide variety of adverse health outcomes.

If these allegations sound wide-ranging and vague, that’s because they are. If you are the least bit science-minded, the following questions come to mind: (1) what does it mean to disrupt the endocrine system? and (2) what kind of adverse health outcomes have been shown to be caused by endocrine disrupting chemicals? Yet, these unanswered questions have not prevented unfounded and wholly unscientific assertions being made in the scientific literature. For example, Leonrado Trasande (Paediatrics professor at New York University School of Medicine) recently wrote:

“Research has suggested a more than 99% probability that these chemicals contribute to disease and disability.”

In the prestigious journal Nature, no less. He also stated in that same piece that removal of certain endocrine disrupting chemicals “could help to prevent autism and loss of cognition.” No definitions, no scientific citations. As Geoffrey Kabat so aptly states in his post in the Genetic Literacy Project:

“When activists deftly exploit public anxiety, weak but fashionable hypotheses can take on a life of their own, becoming a “regime of truth” that cannot be questioned. However, the self-serving overstatement of what is known is not without consequences.”

Endocrine Disrupting Chemical Regulatory Landscape in Europe

The European Union has introduced specific legislative obligations aimed at phasing out EDCs in water, industrial chemicals, plant protection products and biocides. This initiative dates back to a 2012 European Commission conference (Endocrine Disruptors: Current challenges in science and policy). The report that issued (State of the Art of the Assessment of Endocrine Disruptors) was finalized by a contractor hired by the European Commission at the end of January 2012. A listing of substances targeted for further evaluation (as to their role as endocrine disruption) is available.

The European Commission has been working on a proposal for science-based criteria for endocrine disrupting chemicals. However, there has been a great deal of dissent in the scientific community about the adequacy of the proposed criteria to define what constitutes an endocrine disrupting chemical. For example, a group of toxicology journal editors wrote a critical editorial concluding that the Commission was proposing an approach lacking “adequate scientific evidence.” Following the publication of this open letter, a number of other scientists criticized its approach in two separate responses (see here and here).

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Indeed, this is a highly-politicized issue in Europe going back to the European Parliament’s involvement in the original pesticides and biocides legislation. Therefore, high-quality science does not appear to be a priority, but rather a political fix. To illustrate the political nature of the debate, since the proposal for criteria for endocrine disrupting chemicals was initially proposed in June 2016, the European Commission has not been able to gain agreement from its members on a set of criteria. Despite numerous votes that have been scheduled, as of March 1, 2017, a final vote has not been conducted. Indeed, on February 27, 2017, ten members of parliament sent a letter to the European Commission asking to preserve the exception (referred to as a “derogation”) in the European Union’s proposed endocrine disrupting chemical criteria. In this letter, they argue that a change from “negligible exposure” to “negligible risk” was “scientifically more robust” and they assert that it would minimize negative impacts on international trade.

Much of the scientific debate revolves around definitions. Interestingly, some of the same authors who were critical of the conclusions made by the toxicology journal editors offered some important criticisms of their own in a subsequent paper. In this paper, these scientists offer the following four specific scientific issues that must be addressed to understand whether specific chemicals should be considered endocrine disrupting chemicals and whether or not these chemicals have well established health risks:

  1. The lack of rigorous and reliable definitions of terms
  2. Appropriate scientific discussion of the role of the endocrine system and the action of hormones in the body
  3. Establishing sufficient evidence of harm when talking about adverse events
  4. Transparent and systematic methods of reviewing the endocrine disrupting chemical literature

The problems that arise from the types of issues raised in this scientific piece are highlighted in the debate surrounding the chemical bisphenol-A (BPA) and attempts to replace it. For example, when parents see the words “BPA-free” on a product intended for their infants, they make assumptions about the safety of the product. Yet, other related chemicals that may have similar properties, have been used as a replacement for BPA. Thus, without rigorous and proper definitions, we may, as one journalist put it, be playing “whack-a-mole” with hazardous chemicals.

Endocrine Disrupting Chemical Regulatory Activity in the US

The regulation of endocrine disrupting chemicals in the US has a long history, going back to the endocrine disruptor screening program (EDSP), which began at the EPA in the 1990s. The EDSP uses a two-tiered approach to screen pesticides, chemicals, and environmental contaminants for their potential effect on estrogen, androgen and thyroid hormone systems. The EDSP is outlined in two Federal Register Notices published in 1998.

In 2015, EPA released EPA released its reviews of the Tier 1 screening assay results for the first 52 pesticide chemicals in the EDSP, and for each chemical, EPA decided whether additional (Tier 2) testing is necessary.

Risk of Endocrine Disrupting Chemical Litigation in the US

If personal injury or class action litigation proceeds in the US, it likely will not be against endocrine disrupting chemicals as a class. Rather, it is more likely that the plaintiff bar will begin to characterize specific chemical agents as endocrine disrupting chemicals and use US and European Union regulatory actions as a basis for the fact that these chemical agents are indeed harmful to human health. As stated at the outset, a host of chemicals can be implicated, including personal care products, food, household cleaners, agricultural chemicals, pharmaceutical products, and occupational exposures. Personal injury lawsuits are already proceeding against specific pesticides that are listed by regulatory agencies (and inappropriately accepted by many scientists) as endocrine disrupting chemicals.

While it is unclear exactly what types of injuries may be pursued by the plaintiff bar – based on statements made in the published scientific literature, as well as in the popular press –allegations may range from autism to birth defects to cancer.

It will be critical, therefore, for relevant product manufacturers and potential defendants in these law suits to be ready for the coming onslaught. For example, it will be important to maintain a detailed awareness of the voluminous scientific findings relevant to putative endocrine disrupting chemicals, including published research articles, book chapters, and talks at symposia and scientific meetings.

 

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