Introducing TKPlate - food safety without animal testing?
A new platform for modelling and predicting the toxicity of chemicals and what happens to them inside humans and animals marks an important milestone on the road to a future with less or no animal testing in food safety.
Historically, safety assessments of chemicals in food and feed (as well as for medicines, consumer products, industrial and other chemicals) have relied on evidence from animal experiments. This core practice in evaluating risks Viela vai darbība, kas potenciāli var izraisīt nelabvēlīgu iedarbību uz dzīviem organismiem vai vidi from chemicals has, by and large, ensured the safety of our food since the 1950s.
However, society and scientists are increasingly questioning this practice, both for ethical and scientific reasons. We all want to reduce the suffering of the animals – improvements have been made in recent years thanks to promotion of the three Rs – to replace, reduce, and refine animal testing.
The use of alternative tools to generate more representative information about toxicokinetics (TK) (how the body manages chemicals) and toxicity/toxicodynamics (TD) (what chemicals do to the body) is becoming a reality too.
Step forward, “TKPlate”!
Predicting toxicokinetics and toxicity with open-access software
Scientists at EFSA and several top European research organisations teamed up to create “TKPlate”. It is an online platform that offers a space and a suite of tools for scientists and regulators to model and predict TK and TD properties.
Two senior scientists at EFSA – toxicologist Jean-Lou Dorne, and statistician/modeller Jose Cortiñas Abrahantes – are leading this work.
Jean-Lou: “The idea for TKPlate started in 2014 with a scientific report on alternative methods to animal testing that could be used by EFSA’s experts. The report proposed the development of a series of TK and TD models. Toxicokinetics tells us how the body absorbs, distributes, metabolises and excretes the chemical. Toxicodynamics explores the toxic effects on molecules, cells, tissues, organs or a whole organism.”
Jose: “Between 2015 and 2020, EFSA developed these TK models and produced many case studies for a range of species relevant to EFSA’s work: humans, test animals like rats and mice, farm animals and other species that have a role in the food and feed chain such as earth worms. We contracted out to academic partners and national agencies important parts of the work, which have resulted in several successful doctorates by young scientists.”
Unique in the food safety area – what can TKPlate do?
|
Jean-Lou: “As far as we are aware, this platform is unique in the food and feed safety area.”
“It allows risk assessors and others involved in toxicology to model TK and TD processes in all the species included in the platform. Basically, you select the species, the chemical or group of chemicals, input parameters such as the type of exposure, then you run the models with a click.
“It calculates the concentrations of chemicals inside the body from the intakes (TK) and predicts the effects (TD) they can cause. These results can directly replace animal data, reducing the need for new experiments. It works in the opposite direction too; we can estimate exposure if there is data such as blood or urine concentrations. It has many more features including TK-TD modelling and a tool for assessing risks from chemical mixtures.
“You get an automated report at the end that provides details of all the inputs and outputs, data and graphs. This can go directly into the scientific assessment as part of the evidence base.”
Creating the platform – a mammoth effort
TKplate is more than just models, but they are an important part of what the platform offers.
Jose: “The types of models in TKPlate are complex to develop as they reflect a conceptual framework about how a substance interacts with an organism. Of course, all models are a simplification of reality, so the challenge lies in trying to capture the process as accurately as possible, reducing the complexity to achieve something generalisable.
“Trying to mimic the full process within the organism is not realistic, so the challenge is to consider which components to retain to make them as resilient as possible if our assumptions are inaccurate or faulty.
|
“Well-developed models like these, including testing and validation, take at least a year to develop, depending on the complexity of the organism and all components that you want to include. It’s a mammoth effort and the researchers who produced them deserve our thanks. As well as the models produced between 2015 and 2020, others are still being developed today.”
Reliability of TK models
With tools like TKPlate now becoming viable, the focus turns to their reliability as evidence sources.
Jean-Lou: “As with all scientific information, the predictions provided by these models have variability and uncertainty, depending on the data available for the species and the chemical you’re testing. These are reported transparently in a range of case studies using international standards to assess the reliability of each model.”
Jose: “All the modelling work we outsourced required extensive tuning, testing and validation, using not only existing experimental animal data but also additional lab data generated by the contractors. The case studies tested the model results in different contexts and for different species, producing results that are coherent with our expectations. As a result, we’re confident in the reliability and robustness of the models.”
Is TKPlate being used in risk assessments yet?
The integration of the TK models into a user-friendly interface – the platform launched today – is an important step to implement their use in chemical risk assessment at EFSA and beyond.
Carlos Gonçalo das Neves is EFSA’s Chief Scientist and an avid promoter of “New Approach Methodologies” (NAMs) developments such as TKPlate.
Carlos: “The potential of TKPlate and other NAMs tools like it are astonishing. Some software-based NAMs are already in use at EFSA and playing a growing role in some of our risk assessments.
“TKPlate is not being used in EFSA’s assessments yet, but applications of its models are being explored to optimise the platform and to prioritise training for our staff and experts across Europe. This will support its use in risk assessment by EFSA’s scientific panels, hopefully in a near future. And of course we can and want to roll out this support to other EU agencies and national authorities.
|
“We are on the cusp of a new era in chemical risk assessment, which will see not only a welcome reduction in the need for animal testing, much requested by our citizens, but also further improvements in the quality and relevance of the data used in our assessments. I really hope TKPlate will represent a big step forward in this direction.
“Scientific advisory bodies like EFSA are lining up to deliver risk assessments with NAMs. It’s important that regulators and society are reassured that all outputs for supporting decision-making are based on sound science. We are confident that that TKPlate will do its job.”
- Editorial – TKPlate 1.0: An Open-access platform for Toxicokinetic and Toxicodynamic modelling of chemicals in food and feed safety
- Technical report - User Guide for TKPlate 1.0: An open access platform for implementing new approach methodologies in chemical risk assessment through toxicokinetic and toxicodynamic modelling
- Technical report - Applications of TKPlate 1.0 for toxicokinetic and toxicodynamic modelling of chemicals: Case Studies
- External scientific report - Further development of a web-based open-source platform for Toxicokinetic and Toxicodynamic modelling: TKPlate 1.0
How to contact us
EFSA Media Relations Office
Tel. +39 0521 036 149
E-mail: press [at] efsa.europa.eu (Press[at]efsa[dot]europa[dot]eu)
(Only if you are a member of the press)
Ask a Question Service
You have a question about EFSA’s work? Contact our Ask a Question service!