The European Chemicals Agency (ECHA) and the Joint Research Centre scientists have a key role to play in meeting the demand of EU citizens and industry, who want to see a big reduction in mandatory animal testing via new methodologies, Dr Julia Fentem told EURACTIV in an interview.
EURACTIV SPECIAL REPORT ON ALTERNATIVES TO ANIMAL TESTING
The scientific knowledge and non-animal models and tools we now have available enable us to take those decisions responsibly in most cases without any new animal testing,” she said.
Dr Julia Fentem is the head of Unilever’s Safety and Environmental Assurance Centre (SEAC). She spoke to EURACTIV.com ahead of the 2019 conference of the European partnership for alternative approaches (EPAA) “Building confidence for the use of 3Rs” on 29 October.
How many animals die annually from testing worldwide? Do you have data regarding the EU?
Statistics for most countries are not available. The EU leads the way in promoting data transparency on animals used for scientific purposes, and in ensuring implementation of the Three Rs principles, i.e. to replace, reduce and/or refine the use of laboratory animals wherever possible. The Directive 2010/63/EU introduced new requirements for data reporting by the EU member states, and the Commission is required to publish the collated EU data in the new format for the first time in November. Since the scope and criteria have been broadened from reports issued in the past, it is difficult to predict actual numbers.
Could you explain what the 3Rs (Replacement, Reduction and Refinement) approach is? Do you have a practical example?
The concept of the Three Rs, and the underpinning philosophy and principles, was first articulated 60 years ago (in 1959) by Russell & Burch in their book “The Principles of Humane Experimental Technique”. The approach is designed to avoid any unnecessary animal use or suffering in scientific experiments and testing.
These principles are the underpinning of the EU animal protection legislation first introduced in 1986 (Directive 86/609/EEC) and updated in 2010 (Directive 2010/63/EU). Whilst many steps have been taken to reduce the numbers of animals use for product safety assessment purposes since the 1980s, and to refine any studies that were absolutely essential so that the animals involved experienced the minimum suffering possible, the animal testing ban implemented under the EU Cosmetics Regulation was the driver for full replacement of animals by non-animal approaches.
How are you planning to build confidence in the 3Rs as a way to avoid or replace the use of animals?
We must continue to build the confidence to use both existing and new 3Rs approaches for decision-making by all stakeholders, particularly by government regulators and scientists in industry. This is particularly critical when those decisions have consequences for public health, consumer safety and our planet (environmental sustainability). We must be confident that decisions which are made based on applying new 3Rs, non-animal science and novel tools are fully protective of human health and our environment.
We are looking to build confidence by helping to develop the capability and capacity needed with new and much wider groups of industrial and government safety assessors across the world, and also by training our next generation of safety assessors very differently (e.g. in non-animal safety science and exposure-based human health and environmental safety assessment) from how toxicologists and eco-toxicologists were educated in the past. To be confident in our decisions as safety assessors, it is critical we develop skills and experience in how non-animal data are applied in an integrated way to make decisions.
The European Partnership for Alternative Approaches to Animal Testing (EPAA) has a key role to play in continuing to help build the knowledge and expertise needed, e.g. through establishing user forums and holding working sessions where case studies and real-life complex product safety assessments can be discussed by multi-disciplinary groups of regulatory and industrial scientists to increase use and acceptance of new approach methodologies (NAMs).
There are good training programmes run by trade associations, and some university courses where the 3Rs approaches are included. There are also now a few new global partnership initiatives – such as the Animal-Free Safety Assessment (AFSA) collaboration being coordinated by Humane Society International – which will increase our global reach with new non-animal safety assessment training materials and approaches targeted for industrial and regulatory safety assessor communities.
What are the main regulatory challenges to push the 3Rs forward, especially in the EU?
As a safety scientist having worked in the area of non-animal approaches for almost 30 years, for an NGO, in government and in industry, I believe that the scientific knowledge and non-animal models and tools we now have available enable us to take those decisions responsibly in most cases without any new animal testing. For example, computational modelling of human biology responses to relevant chemical exposures, and generating relevant data with human cells and tissues, are often more scientific ways to ensure we protect consumers and ensure that our products are safe for them.
Whilst that is my view of the current status of our safety science (and the future also looks positive as we start to leverage new cutting-edge technologies), many of the current regulatory approaches are still based mainly on traditional animal toxicology testing. Here, we also have to openly acknowledge that animal test data are not always fully predictive of human responses, and we often apply various so-called ‘safety factors’ when extrapolating those data to humans.
A big challenge is one of mindset – it does require a different way of thinking, and for us all to embrace the new science and technology opportunities, to lead for both scientific and regulatory change. This is increasingly the challenge for today’s regulators: how do they best keep up with the latest scientific developments, and how do regulations and guidelines keep up with the safety science and assessment approaches we are now experienced in and confident to use to make decisions within some of our companies.
In the chemicals’ safety assessment area, an excellent international governmental collaboration initiative has been taken in the past few years to accelerate the application of new approach methodologies: APCR- ‘accelerating the pace of chemical risk assessment’.
This could change progress in the implementation of 3Rs, non-animal approaches for chemicals registration and evaluation purposes. This is a priority need in the EU, where consumers, NGOs and industry want to see a big reduction in mandatory animal testing, and where there is a clear leadership role for the European Chemicals Agency (ECHA) regulators and the Joint Research Centre scientists to play in driving the changes needed, working in collaboration with other key stakeholders and leading scientists.
What could the next European Commission and Parliament do in this respect?
Mandatory animal testing for new chemicals is an area to put more focus on, building on the international governmental collaboration that is now in place (APCRA above). The US EPA announced a policy change in September 2019 to eliminate funding for all mammalian studies by 2035 and committed funding to advance research on new approach methodologies (NAMs). A similar commitment from the EU Commission and Parliament would be a significant step in also demonstrating that its world-leading 3Rs legislation, now in place for over 30 years, continues to drive the reduction and replacement of animal testing that EU citizens increasingly expect.