Endocrine Disruptors 
Summary of a position paper of the CRO Forum's 
Emerging Risk Initiative 
November 2012
 Endocrine disruptors (EDC) are 
substances that interfere with hormones 
 Hormones are specialised chemical 
substances which regulate many 
physiological processes and bodily 
functions 
 The system of specialised glands, cells, 
tissues and receptors regulating complex 
bodily functions by the use of hormones 
is called the endocrine system 
Emerging Risk Management | Endocrine Disruptors 
The endocrine system 
2 
Definition and background 
CRO Forum 2012
 EDC disturb the hormonal activities of organisms and can thus 
lead to adverse health effects 
 EDC can act by 
1. Mimicking natural hormones by binding to their receptors, triggering 
physiological reactions at abnormal times or amplifying the activity of natural 
hormones (agonistic effect) 
2. Blocking hormone receptors preventing the binding of natural hormones, leading 
to a reduction in their activities (antagonistic effect) 
3. Indirectly affecting biosynthesis, transport or deactivation of natural hormones 
(agonistic or antagonistic effects) 
 EDC may cause health disorders such as: 
– Breast and ovary cancer, testes and prostate cancer 
– Genital malformations 
– Retarded sexual development 
– Declining sperm count 
– Obesity 
– Neurological disorders (e.g. retarded development of memory) 
Emerging Risk Management | Endocrine Disruptors 
3 
Why EDC are of concern
 First evidence suggesting that some chemicals could impact hormonal 
processes was gathered from observations following the exposure of 
individuals to high concentrations of certain substances 
 This resulted in increased efforts to investigate the potential endocrine 
disrupting properties of certain chemicals 
Emerging Risk Management | Endocrine Disruptors 
4 
History 
The DES case 
 From the 1940s to the 1970s pregnant 
women were treated with diethyl-stilbestrol 
(DES) against miscarriage 
 Offspring had an increased risk of 
developing certain forms of cancer later 
in life 
 DES was banned in 
the 1970s 
The Seveso catastrophe 
 In 1976, a chemical plant explosion in 
Seveso, Italy released large amounts of 
dioxin 
 Following the event, several health 
disorders (incl. impacts on semen 
quality and hormonal 
levels) were observed 
in the affected 
population
 Evidence for potential endocrine disrupting properties of certain 
substances was obtained from observations of reproductive disorders in 
animals 
 Alligators in Lake Apopka, Florida: malformations and 'feminisation' of 
male alligators after a pesticide spill 
Emerging Risk Management | Endocrine Disruptors 
5 
Potential impacts on the environment 
http://en.wikipedia.http://maps.google.ch/ org/wiki/File:Crocnest.JPG
1. Pharma 
 pharmaceutical doses of EDC (e.g. contraceptives) 
 vaccine-additives, dental sealants, haemodialysis materials 
2. Consumer goods 
 polymer products containing Bisphenol-A (BPA) 
 poly fluorinated chemicals (PFC) used as surfactants 
3. Food & beverage 
 natural compounds in plants (phyto-estrogens), e.g. soy 
products 
 remains of pesticides, cleaning chemicals or chemicals 
from food containers 
4. Agriculture 
 pesticides (e.g. DDT) 
Emerging Risk Management | Endocrine Disruptors 
6 
Sources of EDC
Measures at various levels are necessary to prevent EDC and other organic 
micro pollutants from entering the hydrological cycle and/or to remove them 
again: 
1. Measures at the source: regulatory measures, incentive systems, 
intelligent product design, measures to influence consumer behaviour, 
technical measures 
2. Removal of EDC during waste water treatment: upgrade of waste water 
treatment plants necessary (4th cleaning stage, e.g. using powdered 
activated carbon or ozonization) 
3. Removal of EDC from drinking water: necessary due to limitations of the 
first two steps and higher demands on water quality; suitable methods 
are activated-carbon filtering, nano filtration, microfiltration, 
ultrafiltration, reverse osmosis 
Emerging Risk Management | Endocrine Disruptors 
7 
Risk Mitigation: Goal to remove of EDC 
from the hydrological cycle
Research in Emerging Risks Pathways 
Emerging Risk Management | Endocrine Disruptors 8
Loss costs developments 
Emerging Risk Management | Endocrine Disruptors 9
 The focus of regulation has mainly been on testing, screening and 
monitoring chemicals containing EDC 
 Another major objective is preventing or limiting the use of EDC, 
especially with regard to products mainly used by children 
 EU: REACH (2007) regulates the registration, evaluation and authorisation 
of chemicals 
 US: broad range of regulation and involved agencies (EPA, FDA, …) 
 Rest of world: movements to ban the use of BPA in baby bottles and other 
infant products in various countries 
Emerging Risk Management | Endocrine Disruptors 
10 
Regulation of EDC
 There is currently no EDC exclusion in product liability policies 
 Claims and litigation: 
– BPA 
– Atrazine 
– Corexit 
 Insurance loss scenarios: 
– Product liability / product recall 
– Environmental liability 
– Workers' compensation / employers' liability 
– Directors & Officers 
– Life & Health (re)insurance 
Emerging Risk Management | Endocrine Disruptors 
11 
EDC and insurance
 EDC are a truly emerging risk. There is strong evidence for negative 
effects on animal organisms and mounting evidence for effects on human 
health. A direct proof of human health problems and EDC-pollution could 
not be clearly established. However results from animal experiments can 
– to a certain degree – be extrapolated. (competent signals) The 
widespread use and the severe negative and long-term harm to life should 
keep awareness high. 
 Regulation and e. g. liability for clean-water serve as an example for the 
precautions that could help to minimize the risk. 
 Meanwhile the production and release of new EDC is increasing, and the 
environmental and human exposure is growing. Environmental liability 
might lead to an increase in legal actions. Claimants are from a very broad 
array of potentially jeopardized groups such as waterworks, farmers, 
house-owners, tourism/natural reservation agencies, fisheries etc. Under 
US-jurisdiction these claims will drive up defense costs. 
Emerging Risk Management | Endocrine Disruptors 
12 
Summary of current status
 When a causal relationship between human hazard and the discharge of 
EDC has been established, all lines of liability insurance could be affected 
 Key concerns in this regard are 
– environmental stability of EDC 
– long-term exposure 
– late disease onset 
 Insurers should enter a risk dialogue with the EDC producing industries, 
regulators and suppliers 
 Use and release of EDC should be minimised, and EDC should be removed 
from waste water and drinking water 
Emerging Risk Management | Endocrine Disruptors 
13 
Summary of current status
Emerging Risk Management | Endocrine Disruptors 14
Legal notice 
15 
©2014 Swiss Re. All rights reserved. You are not permitted to create any modifications 
or derivative works of this presentation or to use it for commercial or other public purposes 
without the prior written permission of Swiss Re. 
The information and opinions contained in the presentation are provided as at the date of 
the presentation and are subject to change without notice. Although the information used 
was taken from reliable sources, Swiss Re does not accept any responsibility for the accuracy 
or comprehensiveness of the details given. All liability for the accuracy and completeness 
thereof or for any damage or loss resulting from the use of the information contained in this 
presentation is expressly excluded. Under no circumstances shall Swiss Re or its Group 
companies be liable for any financial or consequential loss relating to this presentation.

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RSCH presentation

  • 1. Endocrine Disruptors Summary of a position paper of the CRO Forum's Emerging Risk Initiative November 2012
  • 2.  Endocrine disruptors (EDC) are substances that interfere with hormones  Hormones are specialised chemical substances which regulate many physiological processes and bodily functions  The system of specialised glands, cells, tissues and receptors regulating complex bodily functions by the use of hormones is called the endocrine system Emerging Risk Management | Endocrine Disruptors The endocrine system 2 Definition and background CRO Forum 2012
  • 3.  EDC disturb the hormonal activities of organisms and can thus lead to adverse health effects  EDC can act by 1. Mimicking natural hormones by binding to their receptors, triggering physiological reactions at abnormal times or amplifying the activity of natural hormones (agonistic effect) 2. Blocking hormone receptors preventing the binding of natural hormones, leading to a reduction in their activities (antagonistic effect) 3. Indirectly affecting biosynthesis, transport or deactivation of natural hormones (agonistic or antagonistic effects)  EDC may cause health disorders such as: – Breast and ovary cancer, testes and prostate cancer – Genital malformations – Retarded sexual development – Declining sperm count – Obesity – Neurological disorders (e.g. retarded development of memory) Emerging Risk Management | Endocrine Disruptors 3 Why EDC are of concern
  • 4.  First evidence suggesting that some chemicals could impact hormonal processes was gathered from observations following the exposure of individuals to high concentrations of certain substances  This resulted in increased efforts to investigate the potential endocrine disrupting properties of certain chemicals Emerging Risk Management | Endocrine Disruptors 4 History The DES case  From the 1940s to the 1970s pregnant women were treated with diethyl-stilbestrol (DES) against miscarriage  Offspring had an increased risk of developing certain forms of cancer later in life  DES was banned in the 1970s The Seveso catastrophe  In 1976, a chemical plant explosion in Seveso, Italy released large amounts of dioxin  Following the event, several health disorders (incl. impacts on semen quality and hormonal levels) were observed in the affected population
  • 5.  Evidence for potential endocrine disrupting properties of certain substances was obtained from observations of reproductive disorders in animals  Alligators in Lake Apopka, Florida: malformations and 'feminisation' of male alligators after a pesticide spill Emerging Risk Management | Endocrine Disruptors 5 Potential impacts on the environment http://en.wikipedia.http://maps.google.ch/ org/wiki/File:Crocnest.JPG
  • 6. 1. Pharma  pharmaceutical doses of EDC (e.g. contraceptives)  vaccine-additives, dental sealants, haemodialysis materials 2. Consumer goods  polymer products containing Bisphenol-A (BPA)  poly fluorinated chemicals (PFC) used as surfactants 3. Food & beverage  natural compounds in plants (phyto-estrogens), e.g. soy products  remains of pesticides, cleaning chemicals or chemicals from food containers 4. Agriculture  pesticides (e.g. DDT) Emerging Risk Management | Endocrine Disruptors 6 Sources of EDC
  • 7. Measures at various levels are necessary to prevent EDC and other organic micro pollutants from entering the hydrological cycle and/or to remove them again: 1. Measures at the source: regulatory measures, incentive systems, intelligent product design, measures to influence consumer behaviour, technical measures 2. Removal of EDC during waste water treatment: upgrade of waste water treatment plants necessary (4th cleaning stage, e.g. using powdered activated carbon or ozonization) 3. Removal of EDC from drinking water: necessary due to limitations of the first two steps and higher demands on water quality; suitable methods are activated-carbon filtering, nano filtration, microfiltration, ultrafiltration, reverse osmosis Emerging Risk Management | Endocrine Disruptors 7 Risk Mitigation: Goal to remove of EDC from the hydrological cycle
  • 8. Research in Emerging Risks Pathways Emerging Risk Management | Endocrine Disruptors 8
  • 9. Loss costs developments Emerging Risk Management | Endocrine Disruptors 9
  • 10.  The focus of regulation has mainly been on testing, screening and monitoring chemicals containing EDC  Another major objective is preventing or limiting the use of EDC, especially with regard to products mainly used by children  EU: REACH (2007) regulates the registration, evaluation and authorisation of chemicals  US: broad range of regulation and involved agencies (EPA, FDA, …)  Rest of world: movements to ban the use of BPA in baby bottles and other infant products in various countries Emerging Risk Management | Endocrine Disruptors 10 Regulation of EDC
  • 11.  There is currently no EDC exclusion in product liability policies  Claims and litigation: – BPA – Atrazine – Corexit  Insurance loss scenarios: – Product liability / product recall – Environmental liability – Workers' compensation / employers' liability – Directors & Officers – Life & Health (re)insurance Emerging Risk Management | Endocrine Disruptors 11 EDC and insurance
  • 12.  EDC are a truly emerging risk. There is strong evidence for negative effects on animal organisms and mounting evidence for effects on human health. A direct proof of human health problems and EDC-pollution could not be clearly established. However results from animal experiments can – to a certain degree – be extrapolated. (competent signals) The widespread use and the severe negative and long-term harm to life should keep awareness high.  Regulation and e. g. liability for clean-water serve as an example for the precautions that could help to minimize the risk.  Meanwhile the production and release of new EDC is increasing, and the environmental and human exposure is growing. Environmental liability might lead to an increase in legal actions. Claimants are from a very broad array of potentially jeopardized groups such as waterworks, farmers, house-owners, tourism/natural reservation agencies, fisheries etc. Under US-jurisdiction these claims will drive up defense costs. Emerging Risk Management | Endocrine Disruptors 12 Summary of current status
  • 13.  When a causal relationship between human hazard and the discharge of EDC has been established, all lines of liability insurance could be affected  Key concerns in this regard are – environmental stability of EDC – long-term exposure – late disease onset  Insurers should enter a risk dialogue with the EDC producing industries, regulators and suppliers  Use and release of EDC should be minimised, and EDC should be removed from waste water and drinking water Emerging Risk Management | Endocrine Disruptors 13 Summary of current status
  • 14. Emerging Risk Management | Endocrine Disruptors 14
  • 15. Legal notice 15 ©2014 Swiss Re. All rights reserved. You are not permitted to create any modifications or derivative works of this presentation or to use it for commercial or other public purposes without the prior written permission of Swiss Re. The information and opinions contained in the presentation are provided as at the date of the presentation and are subject to change without notice. Although the information used was taken from reliable sources, Swiss Re does not accept any responsibility for the accuracy or comprehensiveness of the details given. All liability for the accuracy and completeness thereof or for any damage or loss resulting from the use of the information contained in this presentation is expressly excluded. Under no circumstances shall Swiss Re or its Group companies be liable for any financial or consequential loss relating to this presentation.

Editor's Notes

  • #9: Phenomenon The Phenomenon stage commences with the creation/introduction/expansion of products/services/processes that creates a possible change in exposure. It continues until all the exposure from the product/service/process is abated.  Damage Emergence The Damage Emergence stage commences with the observation of damages to a person, property, or reputation which are believed to be linked to a Phenomenon. Damage Emergence is the second stage to occur in the path chronologically, however dependent on the nature of the damage, it is not always the second stage to be identified. This is particularly problematic when the damage results in latent Bodily Injury Claims.  Competent Signals Competent Signals are theoretical or empirical doubts of the correlation between Phenomenon and Damage. These signals may be sent by individual competent observers or through scientific studies. At this stage there is generally no concrete proof of a clear “causal” link to the phenomenon; however due to the concern of a possible link, this is the stage where the actions taken to mitigate exposure will be most effective.  Interest Group Action Interest Groups, which the project team defined as a group of persons having a common identified interest that often provides a basis for action, can include lobbyists, media, consumer groups, Non-Governmental Organizations, political interest groups, attorney groups, etc.  At this stage in the path, an increased amount of activity by one or more of these groups can be seen and often results in an increase in public concern. Again, this stage does not necessarily include scientific proof of an increase in exposure, but it is an opportunity for Swiss Re to examine and quantify exposure to potential losses from the identified phenomenon.  In some cases, this stage may occur prior to real damage occurring due to a perceived fear of future damage. A recent example of this is the high level of media interest in Carbon Nanotubes, which can be used in complex engineering structures or everyday items such clothes. They have become an item of concern due to being likened in shape to Asbestos.  Causal Link Causal link is the establishment of a clear cause and effect relationship between the phenomenon and damage emergence. This may be based on professional opinion or scientific study, but at this stage the Causal Link is not legally validated. Despite this, the establishment of a clear causal link is likely to clear the way for valid claims in the Legal Action for Compensation stage.  Regulation Regulation is the governmental intervention on the acknowledgement of the potential risks of a Phenomenon. Governments usually act upon either the Proportional Principle or the Precautionary Principle. The Precautionary Principle implies that there is a responsibility to intervene and protect the public from exposure to harm where scientific investigation discovers a plausible risk. The Proportional Principle is a way of applying the Precautionary Principle, which states that the benefit of an action or policy must be weighed against the potential risks. It is important to distinguish which principle the government is using when they intervene on a Phenomenon to understand if the potential exposure is great enough to cause a significant number of claims.  Legal Action for Compensation Legal action for compensation is the emergence of litigation based on alleged damage caused by the phenomenon. The court must be persuaded to take the view that a sufficiently strong Causal Link has been established in order to succeed in a Legal Action for Compensation. The burden of proof and the use of class action lawsuits as a method to receive compensation for the damages caused by the phenomenon varies significantly by country, however the Emerging Risks that were studied indicated that the United States has seen the largest amounts of compensation awards paid as a result of legal actions. The United States (due mainly to the prevalence of jury trials) also appears to have a more flexible approach to the standards required to prove causal links.  
  • #12: BPA Especially in the US, claims for a variety of adverse health effects, ranging from cancer to reproductive or developmental abnormalities and from mental illness to obesity, have been based on the exposure to products containing endocrine disruptors. Most of this litigation is focused either on polychlorinated biphenyls (PCB) or, more recently, on bisphenol-A (BPA). While some of the PCB-lawsuits led to high settlements, all, like the aforementioned BPA-claims, involve numerous legal controversies. Among them are causation aspects (in regard to medical, general and specific causation) and the evidence standards applicable for scientific experts in court. As far as plaintiffs did not suffer any personal injury, as in most consumer fraud lawsuits, establishing legal standing was difficult. Atrazine Atrazine is seen as an EDC. Since 2004 it is a subject of litigation on both the federal and state levels of US courts. The plaintiffs claim that exposure to atrazine at any level is harmful to human health. The lawsuits seek class-action remedies, financial penalties and payment for water filtration based on their water being harmful to human health. A recent settlement awarded 105 million USD for the upgrade of water-treatment facilities. Corexit In 2010, Corexit was used in large quantities in the Deepwater Horizon oil spill. The first analysis of the 57 chemicals found in Corexit formulas 9500 and 9527 showed that the dispersant could contain cancer-causing agents, hazardous toxins and endocrine disrupting chemicals. Part of the massive multidistrict litigation for the oil spill involves claims by those who have allegedly suffered injuries from exposure to Corexit. The defendants are BP, Transocean, Halliburton, Cameron International, Nalco – the manufacturer of the dispersant Corexit – and numerous others.