National Competent Authorities for the implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes A working document on the development of a common education and training framework to fulfil the requirements under the Directive - Replacing consensus document of 18-19 September 2013 - Brussels, 19-20 February 2014 The Commission established an Expert Working Group (EWG) to develop a common education and training framework for the EU to fulfil the requirements under Articles 23, and 24 of Directive 2010/63/EU on the protection of animals used for scientific purposes. All Members States and main stakeholder organisations were invited to nominate experts to participate in the work. The EWG met on 22 - 23 February and 19-20 September 2012, and 3-4 July 2013. The objectives of the EWG were to develop a common framework to facilitate meeting the requirements for competence of all those involved in use and care of animals for scientific purposes and free movement of personnel. This document is the result of the work of the EWG meetings (including those on Project Evaluation/Retrospective Assessment1 and Inspection and Enforcement2), discussions with the Member States as well as legal input from the Commission. It was endorsed by the National Competent Authorities for the implementation of Directive 2010/63/EU at their meeting of 19-20 February 2014 with the exception of Appendix V3. Disclaimer: The following is intended as guidance to assist the Member States and others affected by Directive 2010/63/EU on the protection of animals used for scientific purposes to arrive at a common understanding of the provisions contained in the Directive and to facilitate its implementation. All comments should be considered within the context of this Directive 2010/63/EU. It provides some suggestions on how the requirements of the Directive may be met. The content of the document does not impose additional obligations beyond those laid out in the Directive. Only the Court of Justice of the European Union is entitled to interpret EU law with legally binding authority. 1 http://ec.europa.eu/environment/chemicals/lab_animals/pdf/Endorsed_PE-RA.pdf 2 http://ec.europa.eu/environment/chemicals/lab_animals/pdf/endorsed_inspection-enforcement.pdf 3 All contents are fully supported, however, national competence issues prevent formal endorsement of Annex V related to training of Inspectors by the National Competent Authorities for Directive 2010/63/EU. 1 The table of contents: Legal background - Article 23 of Directive 2010/63/EU .......................................................... 4 The education and training framework objectives and structure ............................................... 4 The Educational Process under Directive 2010/63/EU ............................................................. 5 Understanding Article 23(2) requirements ............................................................................ 6 The process ............................................................................................................................. 6 Academic qualifications for functions (a), (b), (c) and (d) ........................................................ 7 PART A Modular Training and Learning Outcomes ................................................................................ 9 Quality criteria for a training module .................................................................................... 9 Terminology used ................................................................................................................. 10 Specialisation for species ..................................................................................................... 10 Exemptions to Modular Training for functions (a), (b), (c) and (d) .................................... 11 Training Modules with the respective Learning Outcomes ................................................. 12 Assessment of Learning Outcomes .......................................................................................... 12 Assessment/pass-fail criteria ................................................................................................ 12 Mechanisms for Supervision and Assessment of Competence ................................................ 13 Qualities required of a good supervisor .............................................................................. 13 The supervision process ....................................................................................................... 13 Assessment of competence .................................................................................................... 14 Review/maintenance of competence ..................................................................................... 14 Continuing Professional Development (CPD) ......................................................................... 15 Recording of Training and Supervision ................................................................................... 15 PART B Approval / Accreditation of Courses ....................................................................................... 16 How should a Training Course be approved / accredited? ................................................. 16 Information requirements for the Course Approval / Accreditation .................................... 17 Principles for an Approval / Accreditation Process ............................................................ 18 Responsibilities of those approving / accrediting courses ................................................... 18 2 Framework for mutual acceptance ........................................................................................... 18 Proposal for an EU Platform and Information Portal on Education & Training ............... 19 PART C Roles, tasks and training for functions in Articles 24 and 25 .................................................. 21 Person(s) responsible for overseeing the welfare and care of animals in Article 24(1)(a) . 21 Person(s) responsible for ensuring information is available on the species housed in the establishment in Article 24(1)(b) .......................................................................................... 23 Person(s) responsible for education, competence and CPD of staff in Article 24(1)(c) ..... 25 Person(s) carrying out project evaluation in Article 38 ...................................................... 27 Designated Veterinarian in Article 25 ................................................................................. 28 Use of live animals for the purposes of education and training ............................................... 31 Justification for the use of live animals in education ........................................................... 32 Justification for the use of live animals in training .............................................................. 32 Project applications and evaluations for the use of animals in education and training ..... 33 Transition from “training” to “working under supervision” .............................................. 35 Appendix I: Modules and the related Learning Outcomes ..................................................... 36 Part 1: Modular structure .................................................................................................... 36 Part 2: Learning Outcomes .................................................................................................. 38 Part 3: Modules .................................................................................................................... 39 Part 4: Learning Outcomes, Measurable verbs and Critical Thinking ............................... 71 Appendix II: Illustrative examples of assessment criteria for Learning Outcomes ............... 74 Appendix III: Illustrative examples of Competence Assessment .......................................... 82 Appendix IV: Training Record Template ............................................................................... 87 Appendix V: Recommendations for Person(s) carrying out inspections under Article 34 .... 92 Inspector Module .................................................................................................................. 95 3 Legal background - Article 23 of Directive 2010/63/EU4 Competence of personnel 1. Member States shall ensure that each breeder, supplier and user has sufficient staff on site. 2. The staff shall be adequately educated and trained before they perform any of the following functions: (a) carrying out procedures on animals; (b) designing procedures and projects; (c) taking care of animals; or (d) killing animals. Persons carrying out the functions referred to in point (b) shall have received instruction in a scientific discipline relevant to the work being undertaken and shall have species-specific knowledge. Staff carrying out functions referred to in points (a), (c) or (d) shall be supervised in the performance of their tasks until they have demonstrated the requisite competence. Member States shall ensure, through authorisation or by other means, that the requirements laid down in this paragraph are fulfilled. 3. Member States shall publish, on the basis of the elements set out in Annex V, minimum requirements with regard to education and training and the requirements for obtaining, maintaining and demonstrating requisite competence for the functions set out in paragraph 2. 4. Non-binding guidelines at the