Advancing Humane Methods Through Harmonisation Activities

Regulatory acceptance of non-animal techniques in one region or country is an open door to international harmonisation and the wider statutory elimination of animal methods. The Science Consortium and its members contribute to harmonisation efforts through the following:

• Membership in the European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM) Stakeholder Forum (ESTAF)
• Stakeholder status with the European Chemicals Agency (ECHA)
• Stakeholder status with the European Medicines Agency (EMA)
• Participation in the OECD as a member of the International Council on Animal Protection in OECD Programmes (ICAPO)
• Participation in the International Organization for Standardisation (ISO)
• Participation in the review of international pharmaceutical and veterinary test guidelines (ICH and VICH)

EURL ECVAM Stakeholder Forum (ESTAF)
The Science Consortium is a member of the EURL ECVAM Stakeholder Forum (ESTAF). EURL ECVAM has a critical role in determining the scientific acceptance and regulatory use of alternative methods both within the EU and globally. Involvement in this forum provides the Science Consortium with the opportunity to influence the policy of this institution. Membership of ESTAF allows the Science Consortium to contribute to the validation process of in vitro methods at key stages, including commenting on EURL ECVAM recommendations on validated test methods.

ECHA
As an ECHA Accredited Stakeholder Organisation (ASO), the Science Consortium contributes to the flow of information from industry to ECHA and vice versa. ECHA is the regulatory agency that oversees the administration of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, and as an ASO, the Science Consortium is invited to comment on the activities of ECHA and is granted access to Member State Committee meetings. The Science Consortium also participates as a member of Partner Expert Groups in the preparation of guidance documents aimed at meeting the REACH testing requirements. These activities allow the Science Consortium to encourage the use of non-animal methods to meet the requirements of REACH.

EMA
The Science Consortium is registered with the European Medicines Agency (EMA) stakeholder database. The EMA is a decentralised agency of the European Union responsible for ensuring all available medicines on the EU marketplace are safe, effective, and of high quality. As an active member of the database, the Science Consortium can participate in discussions about EMA regulations and stay up-to-date on EMA activities, as well as receive invitations to EMA conferences and workshops on specific topics within our area of expertise.

OECD
The Science Consortium works extensively with the Organisation for Economic Co-operation and Development (OECD) through the International Council on Animal Protection in OECD Programmes (ICAPO). ICAPO has a voice at the OECD because Science Consortium members recognised the OECD’s importance in animal testing matters early on and spearheaded the formation of an international coalition of animal protection groups, which was accepted by the OECD as a recognised NGO, on a par with environmental and industry NGOs, in 2002. Since the founding of ICAPO, Consortium member scientists have provided scientific expertise to support ICAPO’s efforts. When participating in ICAPO activities, Consortium scientists represent animal protection organisations from North America, Europe, and Japan.

The Science Consortium’s OECD work has included participation in expert groups developing in vitro assays for endocrine active chemicals, a guidance document to minimise testing overall for endocrine active chemicals, a framework to minimise fish testing for ecotoxicology, a strategy for expediting acceptance of non-animal methods, a test guideline that would halve the number of animals used in developmental toxicity testing, and a strategy for including metabolism in non-animal assays. As a representative of the Science Consortium, PETA US has been very involved in the development of the Adverse Outcome Pathway (AOP) approach.

Representation from the Science Consortium is critical to ensuring that the OECD’s proposed international test standards for both human health and ecological safety use non-animal methods and approaches. The Science Consortium regularly prepares detailed scientific comments on behalf of ICAPO on a wide range of new test guidelines and those undergoing revision. This allows the Science Consortium to influence the development and validation of test guidelines from an early stage. Since test guidelines that require animals are still in use and continue to be developed, our work at the OECD helps to ensure that the best possible science and animal welfare standards (namely reduction and refinement strategies) are included in these test guidelines wherever possible.

Consortium scientists attend the Working Group of the National Coordinators of the Test Guidelines Programme (WNT), which oversees the work of the OECD test guidelines programme. The WNT reports to the Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology (Joint Meeting), which is the policy body overseeing the OECD Chemicals Programme. As a member of ICAPO, the Consortium also participates on the OECD Working Party on Manufactured Nanomaterials (WPMN).

ISO
Science Consortium member PETA US participates on the US Technical Advisory Group to ISO Technical Committee (TC) 229 Nanotechnologies. ISO TC 229 develops standards and guidance documents that shape the direction of nanotechnology testing. In this capacity, Science Consortium members help to develop and standardise in vitro testing strategies for nanomaterials and work toward the implementation of these non-animal approaches.

ICH and VICH
When divergent national testing standards for human and veterinary drugs result in increased animal experimentation, the Science Consortium petitions the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH; as a member of the International Council for Animal Protection in Pharmaceutical Programmes (ICAPPP)), the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), and the European Directorate for the Quality of Medicines and HealthCare (EDQM) to foster harmonisation practices that make use of available non-animal methods. These activities engage ICH, VICH, and EDQM in efforts to support the harmonisation of in vitro technical requirements.