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Article related to: People and perspectives
"What we need now is courage"
Over 200 regulators, scientists and industry hazard assessors came together at ECHA in April to discuss how new approach methods can be used to improve chemical safety. The benefits of these methods are clear – they contribute to better toxicology, lower the demand for animal testing and raise competitiveness as companies will be better able to predict the hazard potential of their products.
We spoke with some of the participants of the workshop to get an insight into the current and future use of these methods.
Why is developing new approach methods important?
Dr Thomas Hartung, Johns Hopkins University
"They are cheaper and faster and allow us to take advantage of the knowledge of the past. REACH has created the largest toxicological database on industrial chemicals in the world and with the new approach methods, we can take full advantage of this data to reduce the need for testing in the future."
Professor Bob van de Water, Leiden University
"From the science perspective, we have to develop methods that are more appropriate for the human situation. These can be, for example, stem cell-derived methods where we more closely mimic the human situation. As for regulatory affairs, the main issue is to prove that these methods can better predict the human situation."
Dr Elisabet Berggren, Joint Research Centre, European Commission
"Compared to traditional animal studies, new approach methods are based on the science and knowledge of how a chemical enters the body, reacts in it and interacts with the biological system. They save animal lives, but they also give a more robust scientific understanding, and can save costs and time. For authorities, screening for chemicals of concern is easier. New approach methods can also speed up the finding of less toxic alternatives."
Dr Anette Mehling, BASF
"We are starting to understand the modes of action induced by chemicals when they react with biological systems. Registrants will be able to read-across better, group their substances and categorise them correctly. This will lead to regulators having more confidence in the data submitted by companies."
Dr Bennard van Ravenzwaay, BASF
"Additional methodologies will improve the quality of read across cases, which the regulators will appreciate. The registrants, on the other hand, will know more surely where they stand if they do their job right."
Dr Russell Thomas, US EPA
"In the US, we intend to use new approaches to more efficiently and quickly evaluate chemicals for safety. New approaches will also help us better understand how chemicals interact with important biological processes and cause toxicity. When we understand how chemicals interact with these processes that happens, we can make better judgements about their relevance to human health."
How can they reduce animal testing?
"The first step is to analyse the REACH database to know the limitations of the animal-based methods. If you think that animal studies are perfect, you will never use new methods. From the data, we know that some of the animal experiments cannot be reliably duplicated. For example, if you retest a substance that is a severe eye irritant, you have a 20 % chance that it comes out as a mild irritant and 10 % chance for a non-irritant result. This shows that the assay is not perfect.
The next step is to compare chemicals with similar properties. We can analyse 15 000 substances in the REACH database and see what the neighbouring chemicals are and conclude on the most probable property. This is a very big step forward and can be even better than doing the animal experiment."
Prof. van de Water
"It all depends on case studies, which need to be developed and validated. If from 20-40 case studies done with alternative models, we get the same conclusion in 95 % of the cases, we will have sufficient confidence on the alternative method and its ability to predict an in vivo situation.
What we also have to realise is that animals do not fully predict the human situation. According to knowledge from the pharmaceutical industry, 70 % of human adversities are predicted in in vivo models. If we can get to 80 % with in vitro models, we are doing a better job for human safety. We have to remember, of course, that it's all based on animal studies."
Dr van Ravenzwaay
"Any accepted read across case will reduce testing on animals. If alternative approaches help to increase the likelihood of acceptance, they will contribute to reducing animal testing."
What are the next steps – when can these methods be more widely used?
"The most important thing is access to the data. People should be able to mine the data and use computational tools to set priorities. I applaud ECHA for making this data available."
Prof. van de Water
"There are already methods that can be used to identify hazards and to check whether hazards identified with in vitro are relevant for in vivo situations. However, there is no overall strategy to replace the animal studies. Hopefully, with the case studies, some of the new methods can be integrated to the strategies for safety testing in the coming years."
"The regulatory acceptance or the confidence in using the approaches is not yet there. As soon as people are comfortable with the predictions these tests make, they will become more popular."
Dr van Ravenzwaay
"What we need now is courage. Courage from registrants to do these studies and courage from the authorities to accept them. We need a few success cases, which will entice registrants to do more studies. This will, in turn, lead to increases in data, better read-across cases and more likely acceptance by authorities."
"I know that chemical similarity is important for the authorities. However, I appeal to the authorities: open up a little and let the biological data speak for itself. If the biology is right, the read across is right. By increased acceptance of biology-based approaches for read across, there are great opportunities to reduce testing on animals."
"These methods are already being used in the US, particularly in the evaluation of chemicals affecting the endocrine system. We are using these methods to identify the chemicals we are most concerned about. There are also proposals by our government to start using these alternative methods instead of traditional methods for evaluating chemicals potentially disrupting the estrogen system."
It's important that both sides of the Atlantic are using these methods in a harmonised way. We need to continue discussions for a more harmonised approach."
Watch the video reportage from the workshop.
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Committee for Risk Assessment:
4-7 and 12-13 June
9-13 and 16-20 September (tentative)
Committee for Socio-Economic
9-13 and 16-20 September
Management Board meeting:
Member State Committee:
24-28 June (tentative)
Biocidal Products Committee: