Congratulations, Dr. McGuinness, on your appointment as executive director of the European Chemicals Agency (ECHA).
ECHA plays a central role in the implementation of the European Union’s legislation on chemicals, and biocidal products. Moreover, the agency’s approach to this mandate will become ever more significant under the ambitious European Green Deal commitments and Chemicals Strategy for Sustainability (CSS).
In our changing geopolitical, social, economic and technological landscape, it is vital to conceive of ECHA’s core mandates of ensuring safety, promoting replacement of animal testing, and enhancing competitiveness and innovation as connected rather than competing, and guided by a unifying vision and robust strategy to achieve the EU’s laudable aims under the CSS.
The European Parliament has observed that “the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA) have put in place strategies to actively reduce and replace animal testing, but the European Chemicals Agency (ECHA) still has to put in place a reduction and replacement strategy”. Examples of ambitious targets for phasing out of animal tests and phasing in of new approach methods (NAMs) and next-generation risk assessment (NGRA) approaches in the chemical space have been articulated by Canada, South Korea, and the United States. They have also been requested by an overwhelming majority of MEPs and more than 1. 4 million respondents to a recent European Citizens Initiative.
Now is the time for ECHA to develop an ambitious strategy, structures, systems and culture that remove barriers to the preferential use and acceptance of suitable NAM and NGRA approaches, consistent with EU law. Humane Society International/Europe, an ECHA-accredited stakeholder organisation, would be happy to work with ECHA and any interested parties to develop future-focused plans, build capacity, and find other ways to help ECHA fulfill its legal obligations. This includes protecting humans and the environment, while ensuring animal testing is only used as a last resort.
HSI recently published a peer-reviewed article with suggestions for modernizing the EU’s overall approach to chemical safety and regulation. The latter included changes that could be made to REACH, which would need political approval through the forthcoming legislative process. The latter include:
- Establishing a new scientific committee on application of NAMsA committee comprised of independent experts in NAM/NGRA-based safety assessment of chemicals could better equip ECHA and member countries to deal with topics related to animal testing, such as testing proposals, review of waiver requests, and review of current practices to ensure they are in line with the last-resort principle. Such a committee could also contribute to the development and implementation of an ambitious reduction and replacement strategy and roadmapand provide independent advice and recommendations to foster and increase the use ofnon-animal methods by registrants.
- Better facilitating grouping and read-acrossGrouping and read-across are oft-cited as a success story as they are the most frequently used adaptations. However, ECHA’s Read-Across Assessment Framework sets the bar excessively high, and the extent to which these approaches either contribute to a reduction in animal use, or trigger additional animal testing due to properties of concern among one or more members of a chemical group, warrants further scrutiny. It should go without saying that the use of alternative approaches to trigger-increased animal testing is contrary to both the letter and spirit of EU law.One way to improve the current approach to grouping and read-across could be for ECHA to encourage and facilitate data sharing across similar substances where relevant information could be read-across. EFSA has proposed that lower priority chemicals could be identified by NAMs informed about adverse outcomes pathways. This would reduce the amount of chemicals within an assessment group and decrease animal testing. It could also be replicated in REACH.
- Augmenting reporting criteriaEvery three years, ECHA publishes a report on the use of alternatives to animal testing. This report could be improved to include: ECHA’s work on the promotion of alternatives to animal testing; the rate of regulatory acceptance of the alternatives submitted, per endpoint; recommendations for registrants and to ECHA itself to improve the rate of regulatory acceptance; and the number and type of new vertebrate tests conducted and requested, with corresponding guidelines for in vitro tests (to ascertain if there is a potential noncompliance).
In 2019, the Administrator of the U.S. Environmental Protection Agency issued an inspiring all-staff memo that read: “Through scientific innovation and strategic partnerships, we can protect human health and the environment by using cutting-edge, ethically sound science in our decision-making that efficiently and cost-effectively evaluates potential effects without animal testing.” In so doing, he charged “all agency leaders to take actions consistent with this vision and to elevate our efforts to the next level”.
It is our hope, Dr. McGuinness, that your leadership can inspire a similar shift in ECHA’s internal culture around animal-free safety science — from a pervasive negative bias that seems to regard NAMs as inferior and leading to a reduction in safety, to a more positive and constructive view that acknowledges the benefits of novel approaches, takes an objective approach to uncertainty, and is motivated to work cooperatively with all stakeholders to get to a ‘yes’ on animal replacement or reduction whenever possible. We wish you all the best as you start your new job.
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