European Partnership for Alternative Approaches to Animal Testing Siegfried Breier, Gernot Klotz CoC

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European Partnership for Alternative Approaches
to Animal TestingSiegfried Breier, Gernot
KlotzCo-Chairs, Work Group 4Implementation
of the 3Rsin Regulation and Decision Making
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Concept
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Mandate

• Identification of hot spots, double and
  unnecessary testing
• Existing legislation
• Up-coming legislation
• Implementation
• Global requirements
• Challenges for the implementation of 3Rs
• Identification and evaluation of drivers
• Assessment of current and evolving practice for
  reporting of animal use
• Appropriate measures to improve implementation of
  3Rs in legislations

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Objectives and actions in 2006

• Define targets in action plan and adequate
  roadmap
• Regulatory review focussed on pharmaceuticals,
  chemicals, cosmetics and plant protection sectors
• Identification of hot spots, potential for
  unnecessary duplication of testing as well as
  problems in the implementation of 3 Rs in
  assessment strategies
• May November 2006 Five workshops and several
  informal meetings with experts from industry,
  authorities, academia and animal welfare
  (background documents and presentations available
  on EPAA website)

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Members

• Astra Zeneca
• BASF
• Bayer AG
• Covance
• DG ENTR
• DG ENV

JRC DG SANCO EFSA EFPIA EMEA Eurogroup for
Animals
GSK Henkel Johnson Johnson Pfizer Syngenta
Plus experts from various competent authorities
and sectors in specific workshops
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Different Legal Requirements

• Different targets and different mechanisms to
  achieve the respective legal objectives
• Testing requirements are varied within relevant
  Community legislation for specific areas
• Test methods are mainly established in guidelines
  and/or legislation

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Hot Spots, Duplication and Unnecessary Testing

• All complex toxicological endpoints, such as
  carcinogenicity and reproductive toxicity entail
  a significant number of animals per test
• Statistical reports on the number of animals used
  for experimental or other scientific purposes do
  not allow an accurate breakdown of figures for
  specific sectors or endpoints
• Potential for additional, unnecessary or double
  testing in all areas

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Challenges for Implementation of3 R approaches
in assessment strategies

• Complex legal situation
• Lack of awareness regarding the availability of
  3R approaches
• Lack of harmonisation of testing requirements at
  international level
• Costs of application of 3R approaches
• Confidence in traditional test methods and impact
  of liability issues

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Next steps
1. Cycle 2006
2. Cycle 2007 ff
EPAA Conference December 18th, 2006

• reporting of animals

• first integration and evaluation across sectors

Recommendations for appropriate measures to
improve
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Thank You! More hard work in 2007!!