"Endocrine disruption will be the health concern that defines the 21th century", claimed Dr Carol Kwiatkowski at the public hearing in Brussels 3 May 2011. Representatives from industry, NGOs and the policy and scientific communities discussed how to move from ambition to action regarding endocrine disrupting chemicals. In addition, the SIN List was extended with 22 chemicals identified as endocrine disrupting chemicals of very high concern
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The public hearing on endocrine disrupting chemicals was arranged by ChemSec and held at Stanhope Hotel, Brussels. Around 75 people attended. Many informative presentations helped to explore and clarify the issue from various perspectives, and the debate climate was friendly but intense. Per Rosander, acting director of ChemSec, welcomed all participants and introduced the day's programme. He expressed his desire for a fruitful discussion on how to move from ambition to action and tackle the very urgent issue of endocrine disrupting chemicals. "We cannot just wait and discuss, we have to act and get this in motion!" said Per.
Video summary of the public hearing. 24 minutes.
Filmed documentation of all presentations
"Regulatory toxicology is blind to EDCs"
The moderator Jacki Davis introduced the first speaker, John Peterson Myers, a scientist with many years experience on EDCs and human health, as well as co-author of the best-selling "Our Stolen Future". Translated into 15 languages, Myers identified the most important success of the book as stimulating millions of dollars in funding for important research.
Myers described the scientific revolution initiated through this research, and compared studying EDCs using traditional toxicological endpoints to studying space with common binoculars. Traditional toxicological endpoints are unable to pick up the adverse effects of EDCs, according to Myers. One reason for this is that EDCs interact with gene expression. Gene interaction occurs even at very low concentrations, and the adverse effects can be delayed for decades and even generations. Exposure in the womb can cause effects for a lifetime. "These are effects at concentration levels that could not even be measured 20 years ago: Parts per billion levels!" said Myers.
John Peterson Myers, Environmental Health Sciences
Endocrine disruption is also challenging to study since it is not possible to predict a low-dose response from a high-dose experiment. Effects at lower doses may in fact be much stronger or of a completely different character from the effects seen at higher doses. Safety margins and threshold values may not exist. 10-15 percent of the chemicals found in all of us are likely to be endocrine disrupting, according to Myers.
Myers also addressed a common misunderstanding: that effects of EDCs in animal studies occur only at irrelevantly high concentration levels. In his presentation, Myers presented data demonstrating that the average human bisphenol A exposure is higher than the levels causing adverse effects in numerous animal studies. "This is in fact good news!" said Myers. "Now that we have found these connections to some of our most serious health threats, we can in fact do something about them. Therefore this meeting is necessary and well timed."
"The tools are available, but we need to act now"
Ninja Reineke from WWF was the next speaker, and her focus was the regulatory history of EDCs. Reineke started by showing the audience a report from 1996, which even then clearly described the problems with EDCs and called for swift actions. Since that time, however, very little has happened. "All this time, exposure has continued and scientific evidence increased. Very limited measures have been taken, and then only addressing single chemicals in specific uses," said Reineke.
Reineke also outlined the processes of REACH and how they can be used to control exposure to hazardous substances through inclusion of substances on a candidate list and subsequent evaluation of these through the routes of authorisation or restriction. "After spending 150 million euro in the EU EDC research strategy, European citizens have the right to have an outcome," said Reineke.
A major obstacle in the regulation of EDCs has been the lack of an agreed definition as to what an EDC is. Existing definitions demand proof of exact mode of action of a chemical in order to classify it as an EDC. "If we wait until we can establish exact mode of actions, we will delay decisions for decades. We need to base decisions on available knowledge and not on lack of knowledge. EDCs should be treated as substances of very high concern within REACH, be put on the candidate list and controlled through authorisation," argued Reineke.
"The SIN List is the fast track to substitution"
ChemSec´s Jerker Ligthart presented the new SIN List and the methodology behind it. He described the difference between the new substances on the SIN List 2.0 List and the ones earlier included, with the latest update focusing solely on chemicals' endocrine disrupting properties.
Ligthart described the process of filtering down 553 substances on the European Commission's list of endocrine disrupting chemicals to the 22 on the SIN List 2.0.
Jerker Ligthart, ChemSec
"There are many more substances than these 22 that have endocrine disruptive properties. Our scope was to include only those that could be identified as ‘Substances of Very High Concern' according to the REACH criteria," said Ligthart. "We already have the science in place; it is time to make use of the information. It is time for action!" he concluded.
"The health concern that defines the 21th century"
Dr Carol Kwiatkowski, from The Endocrine Disruption Exchange (TEDX) research team in the US, gave a video presentation on the methodology of the scientific evaluation of substances for possible inclusion in the SIN List.
Carol Kwiatkowski explained that three experienced scientists from TEDX had worked with evaluation of ChemSec´s substances, one of them was Dr. Theo Colborn. An extensive literature review was performed and the available literature was filtered down to original, high-quality, peer-reviewed studies of relevance for the endocrine disruptive properties of the substances. Many human epidemiological studies were removed because of failure to control for other exposures, said Kwiatkowski.
The three reviewers examined the studies and then described the significant findings in a database handed over to ChemSec. The findings were described and not interpreted by the three reviewers. Still, Kwiatkowski ended her talk by a strong statement: "The more we learn and understand on endocrine disruptive chemicals, the clearer it becomes that endocrine disruption will be the health concern defining the 21th century."
"The SIN List is definitely a useful tool to work with"
Two companies and one investment agency were invited to talk about their experiences using the SIN List for their chemical management. Ian Brunning from Boots in UK was one of them. "We think it is a worthwhile investment. It gives us time to make plans for substitution and we can keep our shelf stocks. It makes good business sense," he said.
Annelise Larsen from IKEA pointed to the lack of information along the supply chain as a major obstacle in chemicals management for companies. She also called for clearer regulation on EDCs, saying, "It is very difficult to work without legislations on this. We need to make a lot of more decisions ourselves and set our own criteria and standards, which is a lot of work!"
Amandine Marqués from MSCI, an institute that develops criteria to rate companies in order for investors to reduce their financial risks, stressed the benefits of the SIN List. "For our clients there are two ways to look at chemical regulation: There are the risks of continuous use of SVHCs, and there are the advantages of finding safer alternatives. For us the SIN List is currently the most comprehensive way to work with this issue," she said.
"The SIN List acts like a shadow government"
After lunch, a panel debate was held which aimed to explore the issue of EDCs from different perspectives and discuss possible solutions. In the panel where:
- Patrick Murphy, team Co-ordinator for Biocides, Endocrine Disruptors and Mixtures, Dg Environment, European Commission
- Dr. Frauke Stock, german Federal Environment Agency (UBA)
- Finn Pedersen, Deputy Head of Division, Danish Environmental Protection Agency
- Per Rosander, Acting Director, ChemSec
- Dr. Erwin Annys, Director REACH / Chemicals Policy, Cefic European Chemical Industry Council
- Dr. Daryl Ditz, Director, Chemicals Program, Center for International Environmental law (CIEl)
All panel members started by giving an introductory remark. Patrick Murphy, DG Environment at the European Commission, said that EDCs are scientifically challenging to regulate since they are defined by a mode of action and not by an adverse endpoint, thereby creating difficulty in drawing regulatory conclusions.
Daryl Ditz, from Center for International Environmental Law, expressed a strong sympathy for companies stuck in the middle between suppliers and consumers, and described the SIN List a very useful guidance tool for both companies and member states.
Frauke Stock, from the German Federal Environment Agency, is involved in Germany's proposal of a substance for the candidate list based on its endocrine disrupting properties, and stressed the need for action. "Criteria and strategies would be very good to have, but we do not need to wait for them to get the work started. We can start now," she said. Erwin Annys from European Chemical Industry Council, on the contrary, stressed the need for criteria before taking further actions.
Erwin Annys, Cefic, Frauke Stock, German Federal Environment Agency, and Daryl Ditz, CIEL.
Finn Pedersen, from the Danish Environmental Protection Agency, which has submitted a restriction dossier for the combination of four phthalates, said, "We think it is more important that we have the right substances on the candidate list than having many substances on the list. The candidate list is only one way to work with this."
Many issues were covered in the subsequent open debate, including cocktail effects, and how to use the candidate list. However, much of the focus was on the SIN List. One of the panellists was of the opinion that ChemSec is not ambitious enough in compiling the list, focusing only on REACH relevant substances rather than pushing for action more broadly. Daryl Ditz, on the other hand, commented on the strong influence of the SIN List on REACH implementation. "The SIN List is acting as a shadow government, which identifies and communicates which Substances of Very High Concern to prioritise," said Ditz.
Some panellists also suggested green lists or positive lists, while representatives from industry argued that more lists just risked generating more confusion.
Another panelist argued that it can be dangerous to focus only on the substances on the SIN List, since other substances could be missed. "If it would stop with these 22, the SIN List would be a failure, replied Rosander from ChemSec. Instead, more substances could be added as new evidence emerges.
Finn Pedersen commented on the usefulness of tools such as the SIN List, noting that Denmark has its own list and that the SIN List could be even more useful than the candidate list. "The candidate list is not systematically developed; it is only a random list," he said.
Finally the panel members were asked to give a few key priorities for policy, business, and science to overcome the deadlock on EDCs.
Finn Pedersen and Erwin Annys both suggested that developing green chemistry could be a good way for chemical industry to move forwards. Frauke Stock appealed to companies. "You should be proactive and do what you think that your customers would want you to do," she said. Stock also called for a better dialogue between scientists and regulators. Daryl Ditz asked for scientists to provide possible solutions and not only descriptions of the problem.
Per Rosander, ChemSec
"I see a willingness to make the system work"
Per Rosander gave some final remarks and closed the conference. His reflections on the day included Pete Myer's call to find new ways to work in toxicology. Rosander also stressed that we need to be creative and brave in how we incorporate this information into legislation. "I see openings; I see a willingness to make the system work. We have different roles in this, and that adds to the dynamics and creativity. I feel optimistic," he concluded.
