European governmental and private centers specializing in the validation of in vitro, in silico, or alternative methods to reduce, refine, and/or replace the use of animals in regulatory toxicology include the following:
European Centre for the Validation of Alternative Methods (ECVAM)
ECVAM was established in 1991 pursuant to a requirement in Directive 86/609/EEC that the European Commission (EC) and its member states actively support the development, validation, and acceptance of methods to replace, reduce, or refine the use of animals in laboratories. The specific duties of ECVAM are to:
- "Coordinate the validation of alternative test methods at the European Union [EU] level
- Act as a focal point for the exchange of information on the development of alternative test methods
- Set up, maintain, and manage a database on alternative procedures
- Promote dialogue between legislators, industries, biomedical scientists, consumer organizations, and animal welfare groups, with a view to the development, validation, and international recognition of alternative test methods"; to this end, has organized more than 60 scientific workshops and task forces
In addition to these core activities, ECVAM has taken on a lead role in:
- Developing internationally recognized validation criteria of new and revised test methods
- Sponsoring independent scientific peer reviews of alternative methods/strategies and publishing statements of validity issued by the ECVAM Scientific Advisory Committee (ESAC) to encourage regulatory acceptance and use of appropriate 3Rs methods
- Establishing the European Reference Laboratory for Alternative Tests (CORRELATE) and advancing, as a project manager and/or lead laboratory, several multi-year, multi-million-Euro integrated research projects aimed at moving away from animal testing for such complex endpoints as acute toxicity, skin sensitization, and reproductive toxicity
- Coordinating international validation studies, including collaborative efforts in partnership with Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) in the United States, the Japanese Center for the Validation of Alternative Methods (JaCVAM) in Japan, and the international Organisation for Economic Cooperation and Development (OECD)
- Supporting the development of integrated testing strategies, including serving as the EC lead for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Guidance on Information Requirements and Chemical Safety Assessment
- Encouraging EU regulatory acceptance of new test methods determined to be scientifically valid
Other AltTox pages with information on ECVAM:
Fund for the Replacement of Animals in Medical Experiments (FRAME)
Within a decade of Russell and Burch's proposal in 1959 of the 3Rs concept of reduction, refinement, and replacement, FRAME was established as a registered charity to advance alternatives to animal experiments in the United Kingdom. Since that time, FRAME has come to be recognized as a leading national and international authority on the 3Rs and toxicology through the following activities:
- Laboratory-based research: FRAME funds an Alternatives Laboratory at the University of Nottingham, which has been involved in the development and optimization of numerous in vitro assays for endpoints such as acute toxicity, ocular and dermal irritation, phototoxicity, and embryotoxicity and has been an active participant in a number of international validation studies for these and other toxicological endpoints.
- Publications: Since the mid-1970s, FRAME has published the peer-reviewed bimonthly journal Alternatives to Laboratory Animals (ATLA), which reports the results of original research as well as workshop and conference proceedings, news items and commentaries, and other information related to the development, validation, acceptance, and use of the 3Rs in toxicology and research.
- Analysis and Advocacy: "FRAME conducts literature-based scientific studies to investigate the justification for using animals in laboratory research and to promote the adoption of the Three Rs strategy wherever possible." Recent initiatives include the development of integrated testing strategies for use under REACH and in the evaluation of endocrine modulating effects; identification of opportunities for the revision and deletion of OECD Test Guidelines; the potency testing and cosmetic use of Botulinum toxin; the use of dogs, cats, nonhuman primates, and transgenic animals in testing and research; testing requirements for food additives and vaccines; and the identification of biomarkers as refinement endpoints. The results and recommendations of these analyses are regularly communicated to government authorities and other key stakeholders through FRAME's involvement in expert committees, scientific conferences, and workshops, as well as through publication in ATLA and other journals.
German Center for the Documentation and Evaluation of Alternatives to Animal Experiments (ZEBET)
Established in 1989 as part of the German Federal Institute for Risk Assessment (BfR), ZEBET is a government center mandated to "bring about the replacement particularly of legally prescribed animal experiments with alternative test methods" by documenting and assessing 3Rs methods, and, as appropriate, "pushing through their recognition both nationally and internationally." Within Germany, ZEBET plays a role in the enforcement of the country's Animal Welfare Act, advising national authorities with respect to available alternatives to animal experiments and preparing expert opinions in response to applications for authorization of animal research projects. ZEBET also maintains a publicly accessible alternatives database, which contains summaries of approximately 800 books, journals, laws, regulations, guidelines, pharmacopeia, dissertations, conference proceedings, and more.
ZEBET is also directly involved in the development and validation of in vitro and other alternative toxicological testing methods, both in-house and through extramural research grants. For example, ZEBET:
- Led the development and successful validation of the in vitro 3T3 NRU Phototoxicity Test, in which mouse fibroblast cells are exposed to a test substance in the presence and absence of UV light to evaluate the potential for sunlight-induced toxicity
- Helped to pioneer the use of mouse embryonic stem cells to screen for agents that might harm developing embryos
- Served as the lead laboratory for the successful ECVAM validation of the Embryonic Stem Cell Test
- Participates in the related EU research initiative, ReProTect, which aims to develop an integrated, non-animal testing strategy for reproductive and developmental toxicity endpoints
- Has been a leading advocate for ending one-year pesticide dosing studies in dogs
- Is represented on the ECVAM Scientific Advisory Committee (ESAC)
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