New regulation on the use of animals in experimentation from July 1 2015

Background for the EU-directive and the New Norwegian regulation of animal experimentation 

• New knowledge on animal welfare
• Better quality on research in Europe
• Promote Researcher mobility by harmonization
• Competition on equal premises with EU

• Stronger and more explicit focus on the 3Rs (Replacement, Reduction, Refinement) 
• Ban of experiments causing severe pain, fear or any other harm that can be long-lasting and that cannot be relieved.
• Severe experiments need special justification (based on harm-benefit assessment) 
• Protection of more species
  • In addition to vertebrate animals,  cephalopoder and cyclostomata, decapodes and honey bees are protected by the regulation 

Competence

• Demonstration and documentation of theoretical and practical skills for all persons doing animal studies
• Continuous professional education and updating of knowledge and skills, is demnaded and must be documented

Application for animal Experiments

• Lower threshold for application – baseline is everything compared to insert a needle
• Severity classification, 4 categories (low, moderate, severe or terminal)
• Ban use of wild-caught, threatened or stray animals without special justification
• Project summaries will be available for the general public
• Retrospective evaluation of experiments

Responsibility for animals in experiments.

The primary investigator (project license holder) is responsible for their experiments.

He/she is has to safeguard that

1. Cause of any unnecessary pain, fear, lasting harm of other negative impact is eliminated as soon as possible

2. That the study is performed in exact accordance with the approval and decision made by Mattilsynet

3. Any deviations and compensatory actions are recorded.

Application must include:

• Publication of project summary
• Severity assessment must be included (low, moderate, severe or terminal)
• Other euthanasia methods than those described in appendix C in the regulation needs special justification
• New demands to application for changes

Project summary should be easily understandable to the public.

Project summary shall be anonymous and do not contain names and addresses of the user or persons involved.

The project summary shall include:

1. Purpose of the study
2. Expected harm/severity for the animals
3. Expected benefit for science or society
4. How many and what kind of animals will be used (totally in this experiment)
5. How are compliance with the requirements for replacement, reduction and refinement safeguarded

Project summary shall not contain information that is subject to confidentiality obligation under the law on public administration (Forvatningsloven)

The application will be processed as quickly as possible, and within 40 or 55 working days, depending on its complexity.

For application of changes in FOTS the following must be described:

1. The purpose of the change
2. What exactly is changed.
3. A updated project summary including

a) Purpose of the study
b) Expected harm/severity for the animals
c) Expected benefit for science or society
d) How many and what kind of animals will be used (totally in this experiment)
e) How compliance with the requirements for replacement, reduction and refinement is safeguarded

  4. If the change cause a different level of severity or benefit of the experiment
 5. How many, and which animals are influenced by the change

The application will be processed as quickly as possible, and within 40 or 55 working days, depending on its complexity.

Mattilsynet charge administrative fees for the FOTS applications

The fees can be found here

The institution shall establish an animal welfare body (AWB) (norw: “Dyrevelferdsenhet”)

Read more about the AWB at UiB here

An overview of severity classes and examples