Whatever their view, the experts are all in agreement with keynote speaker Professor Thomas Hartung as he addresses the audience.
Thomas is speaking at the Lush Prize Conference, where campaigners, industry, scientists and regulators from across Europe gathered today (10/11/16) to discuss the opportunities, successes and threats to 21st century alternative testing.
He continues: “There are 85 million industry chemicals that have been synthesized,” Thomas says. “We have tested very few of them - 10 per cent of that number - and that was before REACH.”
It is estimated that there are 30-60,000 chemicals to test under REACH, and 31st May 2018 brings the final REACH deadline. When it costs approximately $1 million to carry out one test on one substance, this is a matter of economic importance, as well as a health and environmental issue.
Thomas explains that REACH legislation is open to read-across, which involves filling data gaps from structurally similar chemicals. The data from this is more accurate than from animal tests.
He also highlights how companies often don’t realise that others have already carried out a test on a particular chemical. “This data is not accessible in a searchable form. So we downloaded the entire REACH database and by natural language processes we made it searchable.”
One of the problems with REACH is the complexity of the legislation. To help clarify, Laura McCabe from Health and Safety Executive outlines what data will be required for 2018.
She highlights the One Substance One Registration (OSOR) rule, where a substance needs to only undergo tests once under REACH regulations.
She says: “The benefit of One Substance One Registration, is that data will be shared, and this should avoid the duplication of animal tests.”
She also explains that under REACH, non-animal testing is now the default approach for gathering information about skin irritation, eye irritation, and skin sensitisation.
Alternative testing is not an issue confined to Europe. Dr Julia Baines is from the Peta International Science Consortium (PISC), which was created to bring together the expertise of PETA affiliates from around the world.
She stresses the importance of promoting the use of alternative tests: “One test for one substance can consume thousands of animals. We have heard there are tens of thousands of chemicals to be tested, so it is quite possible that it will affect millions of animals - they will suffer and die because of this legislation.”
PISC is working with companies to help them develop testing strategies that do not need animal testing, as thousands of animals are being used in potentially avoidable tests. Julia says: “We have excellent non-animal tests, but we need to make sure these are used and accepted.”
The Last Resort principle means animal testing should only be used under REACH when there is no viable alternative. Julia explains: “The ECHA (European Chemicals Agency) does have a responsibility to ensure registrants have used non-animal testing methods wherever possible.”
Julia ends with a serious message: “Approximately 800,000 animals died as a result of REACH. This number is set to skyrocket so it is more important than ever that we work to minimise the REACH death toll and aim to ensure non animal tests are used wherever possible.”
Dr Gerry Kenna of the Safer Medicines Trust goes some way to suggest how this can be implemented by examining the parallels between drug safety and chemical safety. His organisation aims to replace poorly performing studies with more predictive human biology-based methods, for human efficacy and safety testing of pharmaceuticals and other chemicals.
In relation to testing methods, Gerry highlights the importance of considering how much of a compound someone is likely to be exposed to on a day to day basis - or, what the risk is.
Anything that could cause adverse health effects, harm or damage, is a hazard. The extent to which someone is subjected to the hazard is referred to as its exposure. To illustrate, Gerry asks the audience to think of this like a shark and a human. If there’s a Great White in the water, and you’re bobbing around on a canoe, you’re at a very high exposure to the hazard, and therefore at great risk. If you’re safely sunbathing on the beach, the exposure is minimal, and you’re at no risk of a Jaws style attack.
“We know many drugs cause toxicity and we also know that in many cases there is a much safer drug that is very similar to the toxic one,” Gerry continues. “Many people have been arguing that there must be a smarter way to work, so we can work out the bad compounds quickly. This is the holy grail of toxicity.”
Offering some optimism, Emily McIvor from Humane Society International (HSI) considers what opportunities REACH might provide, alongside the risks. She suggests that the way REACH manages its animal testing process could be replicated across different sectors, to ensure that multiple tests on the same chemical are avoided.
She shows her frustration, however, at the REACH process: “We know that human relevant data is needed but because sufficient animal methods don’t exist regulators are in limbo."
She’s pleased the ombudsman has made an absolute decision that animal testing must only happen as a last resort, but is quick to point out: “The reality of REACH is that it is really very hard to make the European Commision or ECHA actually stick to their rules.”
Her message is clear: “We need to mobilize further to turn our vision into reality.”
Although there is a positive feeling about developments in chemical science, the frustrations felt in the face of REACH are still clear at the Lush Prize Conference. Those thoughts are perhaps summarised most accurately with the wise words of John Maynard Keynes:
“The difficulty lies, not in the new ideas, but in escaping from the old ones.”