DACOPA, Danish Consensus Platform for 3R Alternatives to Animal Experimentation

Since the ECOPA General Assembly in November 2011 in Madrid the ECOPA secretary Mardas Daneshian has been compiling the quarterly “ecopa corner” in the journal ALTEX. The corner introduces the national platforms and provides information on their ongoing activities, thus providing visibility to an international audience. The corners have been well received and it is recommended that each national platform continues to submit relevant updates on a regular basis to benefit from this opportunity. If your platform has not yet been introduced, please provide Mardas with relevant information on your goals and projects.

ECOPA would like to collect examples of national challenges for the upcoming general assembly in Switzerland on 20th November organized by the Swisstox as the 25th Anniversary meeting of the 3R research Foundation. Please have a look at this and register here. ECOPA would like to encourage the exchange of experiences with the new Directive and kindly asks for national reports on the status besides what is collected by the Commission and displayed here.

As the president of ECOPA I was invited to the 1st European Conference on the Replacement, Reduction and Refinement of animal experiments in Ecotoxicology, to be held at the Swiss Federal Institute of Aquatic Science and Technology (Eawag, Dübendorf) in Switzerland from June 28th-29th 2012 by the FP7 project Euroecotox with a very informative and most interesting program presenting the current progresses and challenges for 3R in ecotoxicology. Hopefully this area will be able to bypass many of the obstacles met by animal use in human toxicology by jumping directly into animal (fish and bird) free ecotoxicology and much attention should also be given to education of new ecotoxicologists in the prospects of cell cultures and in silica/QSAR modelling.

Recent inspiring activities defining new approaches to safety testing implementing the 3Rs were a CAAT workshop presented in Brussels published in ALTEX and an AXLR8 workshop entitled "Roadmap to Next Generation Safety Testing under Horizon 2020".

Lisbeth Knudsen


FINCOPA: Finnish Consensus Platform for Alternatives to Animal Experimentation

Fincopa´s year has been nicely busy and productive. A big effort was the organization of the joint meeting of Scandinavian Society for Cell Toxicology and Fincopa on September 21-23, 2011. The president of Fincopa, Tuula Heinonen, acted as the chairperson for the meeting. The seminar was held in Tampere in a nice location by the large lake but close to the city. The theme was “Towards toxicity assessment without animals” which refers to Replacement under 3Rs. The theme was discussed in connection with the lectures in five oral sessions as well as in the Poster session:

  1. Status of EU projects and new developments to replace animal experiments
  2. Impact of the council adopted updated Directive 86/609/EEC, 2010/63/EU
  3. A new paradigm. Away from histopathology-based toxicity assessment
  4. Optimal in vitro cellular model
  5. Significance of biological barriers in toxicity risk assessment
  6. Poster session
The speakers as well as participants (over 100 from 15 different countries) were from different stakeholders of academy, government and industry. The abstract book contained 53 abstracts, and advanced technical solutions were presented by 12 companies in an interesting exhibition. Proceedings will soon be published in the Toxicology in Vitro.

Second marked effort was the commenting of the draft Finnish law that contained implementation of the Directive 2010/63/EU. The implementation of the directive by the Ministry of Agriculture and Forest (the responsible ministry) has proceeded well ahead and according to the schedule.

Annual meeting was organized in May 2012 without scientific session. The scientific workshop will be organized in autumn 2012 in Helsinki. The theme there is Refinement. The challenge for Fincopa is clearly the maintenance of the web page.

Tuula Heinonen


Germany

The requirements of European Directive 2010/63/EU on the protection of animals used for scientific purposes must be implemented into national law in all Member States in 2012. In Germany, where the protection of animals has been enshrined as a state goal in the Constitution since 2002, this has led to the submission of two drafts for a new Animal Protection Act, both of which also include changes to numerous other aspects of animal welfare.

The changes that must be implemented in Germany to comply with the Directive are new provisions for the use of non-human primates in experiments, the banning of experiments that involve severe pain, suffering or distress that is likely to be long-lasting and cannot be ameliorated, and the extension of protection to fetuses in the third trimester of pregnancy.

The draft compiled by the governing coalition (CDU and FDP) was discussed in the German Federal Assembly (Bundesrat) on July 6. The federal states demanded numerous further improvements including a total ban of experiments on great apes unless they aim to preserve the species, the introduction of statutory permission requirements for commercial dog schools – ensuring the specialized expertise of the employees, the obligation to label and register cats and dogs, the ban of “rodeo” shows if they involve pain and distress, the ban of fur farms and the cloning of farm animals. Previously, the Committee for Agriculture of the Bundesrat supported by 17 German animal welfare institutions as well as the German Judicial Society for the Animal Law Protection (Deutsche Juristische Gesellschaft für Tierschutzrecht - DJGT) demanded a complete ban of the display of wild animals in circuses and stated that the relevant clause in the draft was regressive in comparison to the current law.

The draft promoted by the opposition parties was developed by the Green party and is supported by the Social-Democrats (SPD) and the Left party (die Linke). It aims to ban the experimental use of great apes and additionally requires the abolition of horse branding (microchip implants should be used instead), castration of piglets without anesthesia, breeding resulting in the development of extreme characteristics detrimental to the health and welfare of animals, and the use of certain wild animals in circuses. It further introduces a shift of responsibility and accountability for animal welfare issues to producers.

The two competing drafts have sparked lively public discussion on the issue of animal protection in Germany. It remains to be seen how the time line stipulated by the Directive will dictate the final compromise that will become the new law.

Mardas Daneshian


EU research corner

The carcinoGENOMICS project ended by the end of April 2012, with a final Annual meeting and the Final Capacity Building Meeting entitled 'Is the gap filled?'. In this, final meeting representatives of the different groups and stakeholders of the carcinoGENOMICS project met with regulators. This resulted in a series of recommendations to follow-up and to be kept in mind for an eventual carcinoGENOMICS follow-up project in the future. Below there is a short summary attached of what has been achieved during the whole project period. The detailed outcome, resulting of the project work, will be published in a booklet that will be available to download on the carcinoGENOMICS website by the end of August 2012. It will also be possible to download it via the e-book application for iPad/iPhone.

The major aim of carcinoGENOMICS was the development of in vitro methods for assessing the carcinogenomic potential of compounds, serving all kinds of purposes, i.e. the safety of chemical, pharmaceutical, consumer products etc.

Therefore, the discriminative power between genotoxic (GTX) and non-genotoxic (NGTX) carcinogens of a battery of mechanism based in vitro tests covering the most important target organs, i.e. liver, lung and the kidney, was evaluated.

Although the degree of applicability and information depth of the potential tests identified is different for the different organs, the overall task was achieved to a major extent. Thereby, a basis is laid for a number of follow-up activities, e.g. addressing testing of consumer goods such as cosmetics in much more detail, where animal testing for risk assessment is banned in the EU anyhow.

Of major importance was the very positive interaction with regulators of European registration and licensing agencies including the competent authorities of Member States, early on in the project. Similarly, the worldwide context was brought in by organizing an international conference with participation of regulators of the US and others- a satellite to the world congress for alternatives in Rome.

These activities resulted in an intense dialogue between developers, potential users in industrial settings and regulators of authorities, who finally have to accept the applicability of novel alternative procedures for risk assessment in carcinogenesis, e.g. when faced by the submission documents from the enterprises in life sciences. This dialogue has to be pursued.

When highlighting major achievements, and the conclusions to be drawn from these, the following has to be stated:
  • a crucial step in this as in all FP projects regarding alternative methodology, is the identification of “reference” compounds, a series which can be used by others now,
  • the mass of data out of the genomics analyses of all organ cell systems were collated and screened in new techniques and tools, e.g. an integrative pathway analysis of multiple –omics data sets, something that will assist analysis in future
  • the in vitro-based assays for carcinogenicity screening of the diverse partners for liver, kidney and lung, analyzed across the project finally enabled a prevalidation - on this basis, future activities can be easily conceived, and must be pursued in order to use the outstanding value of the project work and results
  • the experimental expertise and procedural knowledge in cell systems and result analyzing accumulated in this project and its partner groups, especially for kidney and liver, should be taken up in future R&D program projects of the EU – and in so far, the brochure of August 2012 will hopefully help and make sure that the status reached in this area is known to the scientific community.


Currently within the ESNATS consortium, a test battery is being developed to assess different aspects of prenatal toxicity such as functional impairments and changes in the differentiation capacity after exposure to well selected reference compounds. More specifically, a test battery, consisting of 3-4 robust test systems, covering different critical time windows of neuronal cell differentiation, is being trained with prenatal toxicants covering various toxicological mechanisms and leading to the identification of panel marker genes covering a wider range of prenatal toxicity. The project will be extended by 6 months and a final workshop on the results will, most likely, be organized on the occasion of the EUSAAT-Linz-meeting on Friday September 6, 2013. Therefore, save the date for this event!

Manon Vivier


Policy corner

Safer regulation for biocidal products
Read more >

European Union Strategy for the Protection and Welfare of Animals 2012-2015.
Read more >

Commission Regulation (EU) No 640/2012 of 6 July 2012.
Read more >

EURL ECVAM issues recommendation on three alternative-to-animal testing methods for carcinogenicity.
Read more >

Report on the ICCVAM-NICEATM/ECVAM Scientific Workshop on Alternative Methods to Refine, Reduce or Replace the Mouse LD50
Assay for Botulinum Toxin Testing.
Read more >


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Joint Information Day on "Organotypic 3D-cell culture models and engineered tissues"
For registration contact.
25 October 2012
Konstanz, Germany
Details available soon here.
 
 
ecopa Annual Conference
19th - 20th November 2012
Zürich Switzerland
Details available here.


 
 
International Primatological Society XXIV Congress
13-17 August 2012
Veracruz, Mexico

38th Annual NCAB-AALAS Seminar
23-24 August 2012
Washington DC, USA

Education in pain research: study design, ethics and experimental reporting
27-31 August 2012
Milan, Italy

Primates: A practical environmental enrichment workshop
3-5 September 2012
Rijswijk, the Netherlands

3rd International Lhasa Symposium
5-6 September 2012
Cambridge, UK

Meeting of Scientific Advisory Committee, SACTAM
5-6 September 2012
Durham (NC), USA

Linz 2012 17th European Congress on Alternatives to Animal Testing/EUSAAT 2012 14th Annual Congress of EUSAA
5-8 September 2012
Linz, Austria

NC3Rs Animal Technicians' Symposium 2012
11 September 2012
London, UK

NC3Rs 2012 CRACK IT Challenges competition launch event
12 September 2012
London, UK

IACUC Animal Welfare Education Program
19-20 September 2012
Little Rock (AR), USA

International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing
19-21 September 2012
Ames (IA), USA

The American Society for Cellular and Computational Toxicology: 1st Annual Meeting
21 September 2012
Bethesda (MD), USA

LAVA Autumn Conference 2012
24-25 September 2012
York, UK

Consensus Meeting: Harmonisation of the Care and Use of Agricultural Animals in Research
26-28 September 2012
Gardermoen, Norway

LASA / UFAW 3Rs Section Meeting
28 September 2012

IACUCs, IBCs & IRBs: Harmonization, Integration & Implementation ... Promoting a Culture of Collaboration
1-2 October 2012
Babson Park (MA), USA

Meeting the Requirements of the Animal Welfare Act: a Workshop
October 3-4, 2012
Beltsville, MD

SCAW's IACUC Training Workshops
4 October 2012
San Diego (CA), USA

2012 NC3Rs/BPS/PhysSoc Symposium – Models of experimental pain: opportunities and challenges
11 October 2012
London, UK

Fish and amphibian embryos as alternative models in toxicology and teratology
11-12 October 2012
Paris, France

BCLAS-ESLAV-ECLAM Symposium
15 October 2012
Liege, Belgium

European Society of Toxicology in Vitro 2012 International Conference, ESTIV2012
16-19 October 2012
Lisbon, Portugal

Joint Workshop on “Organotypic behavior of 3D-cell culturing models to maintain functional capacity: moving from phenotyping to mechanisms
(by invitation only)
22-24 October 2012
Konstanz, Germany

Joint Information Day on “Organotypic 3D-cell culture models and engineered tissues
25 October 2012
Konstanz, Germany

AALAS 2012 National Meeting
4-8 November 2012
Minneapolis (MN), USA

RSPCA/UFAW Rodent Welfare Group meeting 2012
5 November 2012
Hertfordshire, UK

EPAA Annual Conference 'Global cooperation on 3Rs'
16 November 2012
Brussels, Belgium

LASA Winter Meeting 2012
28-30 November 2012

SCAW’s Annual Winter Conference
3-4 December 2012
San Antonio (TX), USA

Alternative In Vitro Methods to Characterize the Role of Endocrine Active Substances (EASs) in Human Hormone-targeted Tissues
17 December 2012
Rome, Italy

 
 
Compulsory
microchipping of dogs

Deadline: 08 August 2012

Measures on animal cloning for food production in the EU
Deadline: 03 September 2012

Consultation on the Protection of Animals at the Time of Killing
Deadline: 03 September 2012


 
 
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