Presentation: Working together as Industry & Regulatory Communities to make Safety Decisions without Animal Testing

Julia Fentem, Carl Westmoreland, Gavin Maxwell, Paul Russell, Matthew Dent & Paul Carmichael

EPAA Annual Conference, Brussels, 29th October 2019

The theme for the EPAA annual conference in Brussels in October 2019 was “Building Confidence for the use of 3Rs”. To do so it is critical that we work together across all stakeholders, in an open and transparent manner, to lead for regulatory change in replacing animal testing. 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 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 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 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. 

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 NAMs: APCRA – ‘accelerating the pace of chemical risk assessment’.  This could step-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.  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 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.

View the presentation slides here.

A replay of the webcast of this presentation is available at: (starts at 12 minutes, 14 seconds).

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