EK šalje na recenziju prijedlog dokumenta o genetički izmijenjenim životinjama

Dear FELASA BoM representatives,

The European Commission sent their draft guidance document on genetically altered animals (GAA) for review. Please distribute to the relevant colleagues (i.e., association members and other stakeholders like animal welfare officers who are not members etc) and send comments to FELASA Secretariat felasa@husmail.com by Friday 25th June 2021. Please see attached and Susanna’s explanation below:

“The guidance document on GAA under Directive 2010/63/EU is reaching its final stages.

We are grateful for the feedback and contributions received from you and your experts throughout the process starting from the EWG that was convened in 2018 and the work by the respective sub-groups since then.

As discussed at the NCP20, please find attached the draft final version of the Guidance for Genetically Altered Animals under Directive 2010/63/EU on the protection of animals used for scientific purposes.

The process has been lengthy, but we hope that the extensive exchanges and several revisions will have allowed us to develop a guidance document that will be useful for all involved.

The order of sections has been changed to render the document more user-friendly.  We have some specific comments concerning the previously commented sections:

  • Sections on Animal Welfare Assessments and Transfer document was finalised on the basis of the last round of feedback (including experts), and presentation aligned between species. We do not expect any further changes to be requested to this section.
  • Section on Three Rs implementation has received numerous comments both from MS and experts. The most difficult task has been to set an appropriate level of detail in the guidance in an area where technological advances are rapid. Because the development of this guidance has taken some time, it already became apparent that in some cases too detailed recommendations were emerging, which were already becoming outdated. It is important to strike the right balance between clear presentation of principles and approaches to be respected when addressing GAA and the level of detail in recommendations. As a result, you may find that some of the detailed comments received from your experts are not incorporated in this final draft. Furthermore, where feedback from the experts was mixed and conflicting, the related recommendation will highlight the area of concern and recommend that the latest scientific advice on the topic is sought. We do not expect any further changes to be requested to this section.

We would like your comments and feedback, if any, for parts of the document that have not been previously commented on:

  • Section 1 – Administrative procedures
  • Section 5 – Reporting
  • Annex II – Project application and evaluation for the creation and maintenance of GAA lines
  • Annex IV – Glossary of terms

Sections on Administrative procedures (1) and Reporting (5) have been drafted on the basis of the legal texts of both the Directive and related Commission Implementing Decision 2020/569/EU.

  • The section on Administrative procedures is based on the principle that GAA authorisations should be at the level of disease areas (see Article 3(2) ‘a programme of work having a defined scientific objective and involving one or more procedures’) and using simplifications permitted under the Directive, where appropriate and permitted.  This section is supported by Annex II aiming to address key elements from the perspective of the project applicant and project evaluator.
  • The section on reporting was largely driven by the type of questions received in feedback during previous interactions with NCPs and experts. This section also aims to address problems that were encountered during the preparation of the first implementation report in 2018 and statistical reports since 2015.

For Annex II, specifically we ask you to:

  • Consider whether the service projects type descriptions are helpful
  • Consider whether text split by different service project types is helpful or could be simplified by combining all service types
  • Provide comments and suggestions to improve clarity

For Annex IV, please check for omissions, and where considered necessary suggest alternate definitions / wording to improve clarity.

As a final comment, please note that we intend to amend the flow chart on page 17 for the final version of the guidance: on the second row, middle box “Mating two GA lines to create a new line” will have an exception added, stating “When crossing/backcrossing two lines of non-harmful phenotype and it can be reasonably expected that the new line will not result in a harmful phenotype, the requirement for a project authorisation may not apply.”

When providing your feedback, please bear in mind that these guidance documents do not impose obligations beyond the Directive. Their aim is to provide ways to facilitate common understanding and implementation.

Depending on national situation, some elements may not be relevant to your processes. However, their inclusion may be of guidance to others.”

Take care
Dr J-P Mocho MRCVS MVDr DVM
FELASA Honorary Secretary